Lunar Prodigy

426
PRODIGY Service Manual Part Number: LUN7396 Revision: C

Transcript of Lunar Prodigy

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PRODIGY

Service Manual

Part Number: LUN7396 Revision: C

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This document contains confidential or proprietary information of GE-Lunar Corp. neither the document nor the information is to be reproduced, distributed, used or disclosed, either in whole or in part, except as specifically authorized by GE-Lunar Corp.

GE-LUNAR Corporation makes no warranty of any kind with regard to this material, and shall not be held liable for errors contained herein or for incidental or consequential damages in connection with the furnishings or use of this manual.

Read through this manual thoroughly before attempting to service any components. Unauthorized service may void system warranties or service contracts. Consult the GE-LUNAR Customer Support Department prior to attempting any servicing:

608-828--2663

608-826-7107 (Fax)

g is a registered trademark of General Electric Company.

PRODIGY® is a trademark of GE-LUNAR Corporation.

Windows NT® is a trademark of Microsoft Corporation

Copyright© 2000 by GE-LUNAR Corporation.

Madison, Wisconsin. All rights reserved.

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READ THIS FIRST

Using This Manual:

A person who will be performing service work on the PRODIGY should use this manual in the following manner:

Read the Safety and Overview Chapters to familiarize yourself with the scanner as a whole and with the general function of the circuit boards.

Chapter 3 should be understood completely as it explains the Diagnostics Software (built in – requires a password for access).

The Chapter 4 and Chapter 5 contain common procedures and troubleshooting information and can be read as needed, but are good sources of information.

When a problem arises, Chapter 4 should be referenced. Check the table of contents for Chapter 4 to see if the problem being experienced is described. If so, refer to the appropriate page. If not, try to generalize the problem (e.g. the Detector is repeatedly running into the front of the scanner and reversing and then running back into the front of the scanner. This is a mechanical problem in general, specifically with Transverse Mechanics, check that subsection of Chapter 4 for the subsystem experiencing the fault.

This manual commonly references other Sections and pages of the manual as needed, so often procedures in the Chapter 5 Appendix are referred to as ways to solve problems described in Chapter 4.

Information Requested By GE-LUNAR:

When requesting assistance from GE-LUNAR, please provide the following information:

System Number (DF+xxxxx)

Institution or Doctor's name

Location

Complete list of symptoms

Names and part numbers of parts needed for service

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In addition to the information above, an Error Log printout and QA’s and QA history or other failing diagnostic test printout (Alignment Test etc.) will also help to improve the accuracy of our diagnosis:

For problems with specific patient scans, it is recommended that you copy the scan files to diskette, and send it, with a description of the problem, to the Applications Department at GE - LUNAR.

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1 1112Safety

Chapter 1:Safety This chapter highlights safety devices and features a Service Engineer should know before servicing a PRODIGY system.

Chapter Contents:

1.0 General Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-151.1 Symbols and labels found on the PRODIGY . . . . . . . . . . . . . . . . . . 1-15

1.1.1 External Symbols. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-151.1.2 Internal Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-161.1.3 Labels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-16

1.2 Emergency Stop Button . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-191.3 Laser Exposure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-201.4 Shutter Indicator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-211.5 Cautions, Warnings, and Notes . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-21

1.5.1 Caution Statements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-211.5.2 Warning Statements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-221.5.3 Note Statements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-22

1.6 Safety Concerns . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-221.6.1 Pinch points . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-221.6.2 Laser safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-231.6.3 Radiation safety. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-241.6.4 Scatter Radiation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-24

1.7 Controlling Computer and Accessories . . . . . . . . . . . . . . . . . . . . . . 1-261.7.1 Electrical Safety. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-261.7.3 Peripheral Configurations . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-261.7.4 Standard room configuration (system no. DF+12000 and greater)1-

261.7.5 Small room configuration (system no. DF+12000 and higher) 1-271.7.6 Scanner power output configuration (system no. DF+11999 and

lower) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-271.7.7 Wall outlet configuration (system no. DF+11999 and lower) . . 1-27

Figure 1-1. The PRODIGY Display Panel . . . . . . . . . . . . . . . . . . . . . . . 1-19Figure 1-2. Laser Warning Label (U.S. systems only) . . . . . . . . . . . . . . 1-20Figure 1-4. Laser Warning Label (International systems only) . . . . . . . . 1-20Figure 1-5. Source (x-rays) off - Shutter closed (green) . . . . . . . . . . . . . 1-21

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Figure 1-6. Source (x-rays) on - Shutter open (yellow). . . . . . . . . . . . . . 1-21Figure 1-7. Potential Pinch Points on the PRODIGY . . . . . . . . . . . . . . . 1-23Figure 1-8. PRODIGY Iso-Dose Diagram . . . . . . . . . . . . . . . . . . . . . . . . 1-25

This document contains confidential or proprietary information of GE-Lunar Corp. Neither the document nor the information therein is to be reproduced, distributed, used or disclosed, either in whole or in part, except as specifically authorized by GE-Lunar Corp.

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1.0 General Safety• DO NOT attempt to service the PRODIGY without first reading this

manual.

• DO NOT attempt any repairs without prior instructions from authorized LUNAR personnel.

• In order to maintain electrical safety and electromagnetic compatibility, the Lunar PRODIGY is only to be connected to a computer, printer, and peripherals that are certified to be compliant with IEC 950/EN 60950 Safety of information technology equipment, including electrical business equipment and IEC 601-1-2 Medical electrical equipment, Part 1: General requirements for safety, 2. Collateral Standard: Electromagnetic compatibility - Requirements and tests.Emergency Stop Button

1.1 Symbols and labels found on the PRODIGY1.1.1 External Symbols

• The following symbols are found on the PRODIGY, in the Operators manual, and in the Service Manual.

Attention: contains important safety information such as the location of a pinch point.

Emergency Stop Button: shows the location of the emergency stop button.

Power On: shows the location of the Power On indicator and the switch position for Power On.

Power Off: shows the switch position for Power Off.

Laser On: shows the location of the Laser On indicator. It is found only on systems delivered internationally.

This document contains confidential or proprietary information of GE-Lunar Corp. Neither the document nor the information therein is to be reproduced, distributed, used or disclosed, either in whole or in part, except as specifically authorized by GE-Lunar Corp.

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Shutter Open: shows the location of the Shutter Open indicator.

X-ray On: shows the location of the X-Ray On indicator.

Type B Equipment: shows that the scanner has Type B protection against electrical shock.

1.1.2 Internal Symbols

• The following symbols are found inside the PRODIGY, and in the Service Manual.

Protective Earth: shows the location of a Protective Earth Terminal.

Functional Earth: shows the location of a Functional Earth Terminal.

1.1.3 Labels

• The following labels are found on the PRODIGY Scanner.

Laser Caution Label: Shows that the scanner uses a Class II laser. This label is not found on systems shipped to Canada.

Laser Caution Label: Canada only

This document contains confidential or proprietary information of GE-Lunar Corp. Neither the document nor the information therein is to be reproduced, distributed, used or disclosed, either in whole or in part, except as specifically authorized by GE-Lunar Corp.

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Tube Head Assembly Label (system number DF+12000 and greater): This label gives tube head assembly and x-ray source characteristics information. It is located on the tube head assembly and the foot panel of the scanner.

Tube Head Assembly Label (system number DF+11999 and lower): This label gives tube head assembly and x-ray source characteristics information. It is located on the tube head assembly and the foot panel of the scanner.

A definition of each symbol on this label follows:

Inherent Filtration

Tube Insert

X-ray Source

Focal Point

System Label (system number DF+12000 and greater): This label gives system input power requirements and compliance information. It is located on the foot panel of scanners. The CE mark shows compliance with UL/CSA and the Medical Device Directive 93/42/EEC.

System Label (system number DF+11999 and lower): This label gives system input power requirements and compliance information. It is located on the foot panel of scanners. The CE mark shows compliance with UL/CSA and the Medical Device Directive 93/42/EEC.

This document contains confidential or proprietary information of GE-Lunar Corp. Neither the document nor the information therein is to be reproduced, distributed, used or disclosed, either in whole or in part, except as specifically authorized by GE-Lunar Corp.

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High Voltage Power Supply: This label gives high voltage power supply (x-ray generator) information. It is located on the positive and negative power supplies, and foot panel of the scanner.

X-ray Controller: This label shows x-ray controller compliance. It is located on the foot panel of the scanner.

Collimator Assembly: This label gives collimator assembly information. It is located on the collimator and foot panel of the scanner.

Warning Label and Radiation Symbol: The Warning label shows that the system uses ionizing radiation. It is found only on systems delivered in the United States. Always obey instructions for safe operation.

Radiation Label: This label shows that the system uses ionizing radiation.

Grounding Reliability Label: This label states that grounding reliability can only be maintained when using a “Hospital Grade” or “Hospital Only” receptacle. It is only found on systems delivered in the United States.

This document contains confidential or proprietary information of GE-Lunar Corp. Neither the document nor the information therein is to be reproduced, distributed, used or disclosed, either in whole or in part, except as specifically authorized by GE-Lunar Corp.

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1.2 Emergency Stop Button• The Emergency Stop Button is a round red button located on the scanner

display panel (see Figure 1-1). When pressed, power is removed from the X-ray tube head, the laser, and the shutter is closed. Power is also removed from the scan arm motors, allowing the operator/patient to push the scan arm out of the way.

Figure 1-1. The PRODIGY Display Panel

This document contains confidential or proprietary information of GE-Lunar Corp. Neither the document nor the information therein is to be reproduced, distributed, used or disclosed, either in whole or in part, except as specifically authorized by GE-Lunar Corp.

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1.3 Laser Exposure• The PRODIGY is equipped with a Class II Laser device. This laser is

used for patient positioning. A Class II rating indicates a low power visible laser that is not normally hazardous to eyesight but has the potential to be hazardous if viewed directly for an extended period of time. Because of this potential hazard, DO NOT stare directly into the beam while the laser is in operation, and DO NOT allow the beam to shine directly into the patients' eyes. No specific eye protection is required with a Class II laser.

• A amber laser-on indicator, located on the front of the scan arm, is lit when the laser is on. The program activates the laser during positioning for an image acquisition. The program then turns off the laser when you begin the scan. The emergency stop button will turn off the laser.

• There is a caution label (Figure 1.2) on the scan arm near the Display Panel.

Figure 1-2. Laser Warning Label (U.S. systems only)

Figure 1-3. Laser Warning Label (Canadian Systems only)

Figure 1-4. Laser Warning Label (International systems only)

Note: DO NOT STARE INTO THE BEAM while the laser is operating.

This document contains confidential or proprietary information of GE-Lunar Corp. Neither the document nor the information therein is to be reproduced, distributed, used or disclosed, either in whole or in part, except as specifically authorized by GE-Lunar Corp.

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1.4 Shutter Indicator• This symbol is used to indicate an open-shutter condition in accordance

with the safety standards established by the International Electrotechnical Commission (IEC).

Figure 1-5. Source (x-rays) off - Shutter closed (green)

Figure 1-6. Source (x-rays) on - Shutter open (yellow)

• This symbol appears near the yellow X-ray shutter-open indicator light. The X-ray shutter-open indicator light is located on the Display Panel on the scan arm near the front.

Note: When the x-ray on / shutter open symbol appears in literature associated with the PRODIGY scanner, it will be used to indicate that the procedure being described results in an open-shutter condition. During these times personnel should exercise caution to avoid excessive exposure to the X-rays.

1.5 Cautions, Warnings, and Notes• This manual contains warning and caution statements wherever

appropriate for your safety. The warnings and cautions used throughout the manual are based on the safety standards established by the International Electrotechnical Commission (IEC). In addition, the manual uses notes to attract the reader's attention to important information.

1.5.1 Caution Statements

A caution statement reflects a condition that, if not avoided, could cause equipment or property damage.

This document contains confidential or proprietary information of GE-Lunar Corp. Neither the document nor the information therein is to be reproduced, distributed, used or disclosed, either in whole or in part, except as specifically authorized by GE-Lunar Corp.

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1.5.2 Warning Statements

A warning statement reflects a potentially hazardous condition that, if not avoided, could result in serious injury.

1.5.3 Note Statements

Note: This symbol turns the reader's attention to important information which may otherwise be overlooked.

1.6 Safety Concerns1.6.1 Pinch points

The Warning label below identifies the location of possible pinch points

Because the PRODIGY Densitometer contains moving parts, there are places on the scanner where there is a danger of pinching. Operators should be aware of these pinch points to avoid injury to

the patient or themselves. When the scanner arm is in motion, make sure possible pinch point locations are clear at all times. Labels applied at the LUNAR factory indicate the location of the pinch points. The pinch points and their labels are shown in the figure 1-7.

This document contains confidential or proprietary information of GE-Lunar Corp. Neither the document nor the information therein is to be reproduced, distributed, used or disclosed, either in whole or in part, except as specifically authorized by GE-Lunar Corp.

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Figure 1-7. Potential Pinch Points on the PRODIGY

Do not touch the AC Surge Suppressor (located on the AC terminal block) it may be hot.

Do not electrically connect the isolation transformer bolt head to ground, doing this will short out the transformer

Scan table isolated outlet strip must be appropriately connected.

1.6.2 Laser safety

DO NOT STARE INTO THE LASER BEAM during patient positioning and Quality Assurance procedures.

The label that follows is located on the scanner arm and shows the location of the laser aperture.

This document contains confidential or proprietary information of GE-Lunar Corp. Neither the document nor the information therein is to be reproduced, distributed, used or disclosed, either in whole or in part, except as specifically authorized by GE-Lunar Corp.

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1.6.3 Radiation safety

X-ray exposure: The system makes radiation when electric voltage is supplied to, and current flows through, the x-ray tube. During a measurement, the shutter opens to let a beam of radiation pass through the scanner table and patient. The radiation field at the table top is 19.2 mm x 3.3 mm. Lead oxide shielding surrounds the x-ray tube insert inside the tube housing assembly and reduces radiation levels around the scanner table.

Skin entrance dose: Table 1 of the PRODIGY Operators Safety and Specifications manual shows irradiation times and skin entrance doses.

1.6.4 Scatter Radiation

• There is some scatter radiation from the PRODIGY when it is running. Figure 1-8 shows the radiation dosages while the scanner is running at 3.00 mA at certain distances.

• These dosages are relatively insignificant as the allowed yearly dosage for a person working with radiation emitting equipment is 5000 mRem. Radiation however should be avoided when possible.

This document contains confidential or proprietary information of GE-Lunar Corp. Neither the document nor the information therein is to be reproduced, distributed, used or disclosed, either in whole or in part, except as specifically authorized by GE-Lunar Corp.

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Figure 1-8. PRODIGY Iso-Dose Diagram

This document contains confidential or proprietary information of GE-Lunar Corp. Neither the document nor the information therein is to be reproduced, distributed, used or disclosed, either in whole or in part, except as specifically authorized by GE-Lunar Corp.

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1.7 Controlling Computer and Accessories1.7.1 Electrical Safety

IEC and UL/CSA certification

IEC: To maintain electrical safety, all computer equipment and accessories connected to the scanner must meet all IEC requirements for safety, such as IEC 950, "Safety of information technology equipment, including electrical business equipment," and IEC 801-5, "EMC Surge Immunity Requirements." The computer and all accessories must have the CE label.

UL/CSA: To maintain electrical safety, all computer equipment and accessories connected to the scanner must have safety agency approvals for UL/CSA.

1.7.2 Electromagnetic interference

Although the scanner meets safety standards regarding electromagnetic interference (EN60601-1-2), you may still experience a loss of performance under extreme electromagnetic conditions. Maximize the distance between the scanner and other equipment, and use a dedicated power line, to avoid interference to and from the scanner.

1.7.3 Peripheral Configurations

The correct connection of the computer and all peripherals is necessary to maintain electrical safety. The signal cable of the scanner is intended only for connection to an approved computer. Call LUNAR Support or your LUNAR

distributor before adding peripherals.

Note: The scanner's output power strip can be used to supply the Host PC with isolated power. If it is to be used the following conditions must be met. If the conditions cannot be met, the scanner's output power strip cannot be used.

Note: See also Peripheral Block Diagrams - Section 2.2.3

1.7.4 Standard room configuration (system no. DF+12000 and greater)

The computer, peripherals, and all other equipment must be located more than 1.83 m from the scanner. Use an outlet strip to power the computer and all peripherals. The outlet strip must be mounted off the floor so that it does not touch other equipment. If your outlet strip was provided by LUNAR, it has a maximum output of 15A, 120VAC. Only system-related equipment should be powered by the outlet strip.

This document contains confidential or proprietary information of GE-Lunar Corp. Neither the document nor the information therein is to be reproduced, distributed, used or disclosed, either in whole or in part, except as specifically authorized by GE-Lunar Corp.

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A modem and/or network connection can be made at any time if you are using the standard room configuration.

1.7.5 Small room configuration (system no. DF+12000 and higher)

You must power the computer, peripherals, and all other equipment with an isolating transformer if the room is too small to maintain at least 1.83 m of separation between the scanner and all other equipment.

The isolation transformer supplied by LUNAR has a maximum output of 400/500VA. Only system-related equipment should be powered by the isolation transformer. Failure to use an isolation transformer can cause leakage currents in excess of 100 microamperes.

A modem and/or network connection can only be made in the small room configuration if all exposed metal surfaces of the computer and peripherals are out of the patient environment.

1.7.6 Scanner power output configuration (system no. DF+11999 and lower)

LUNAR recommends that you use scanner power output to provide isolated power to the computer and all peripherals. The power strip must be mounted off the floor such that it does not touch other equipment. The computer and ALL peripherals must be powered by the scanner. All other equipment must not be powered by the scanner and must be located more than 1.83 m from the scanner. Failure to use scanner power output can cause leakage currents in excess of 100 microamperes.

If a network and/or modem connection is needed, refer to the wall outlet configuration.

1.7.7 Wall outlet configuration (system no. DF+11999 and lower)

As an option to scanner power output, a wall outlet can be used to power the computer and peripherals. Isolated power from the scanner must not be used to power any equipment if a wall outlet is used. All exposed metal surfaces of the computer, peripherals, and other equipment must be located more than 1.83 m from the scanner.

A network and/or modem connection can be made to the computer if power is supplied from a wall outlet as described above.

This document contains confidential or proprietary information of GE-Lunar Corp. Neither the document nor the information therein is to be reproduced, distributed, used or disclosed, either in whole or in part, except as specifically authorized by GE-Lunar Corp.

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This document contains confidential or proprietary information of GE-Lunar Corp. Neither the document nor the information therein is to be reproduced, distributed, used or disclosed, either in whole or in part, except as specifically authorized by GE-Lunar Corp.

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2 1112System Overview

Chapter 1:System Overview This chapter provides an overview of the PRODIGY system.

• In addition the chapter contains a brief discussion of major sub-systems and illustrations of the PRODIGY power system.

• This Chapter contains the PRODIGY Block Diagrams

2.0 PRODIGY System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-332.0.1 PRODIGY Electronics . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-33

2.1 Electronics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-352.1.1 Cautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-352.1.2 Electronics Pan . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-352.1.3 Scan Arm. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-362.1.4 Power specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-36

2.2 PRODIGY Block Diagrams. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-382.2.1 PRODIGY I (System numbers DF+11999 and lower) Power Distribution Block Diagram (AC entrance) . . . . . . . . . . . . . . . . . 1-382.2.2 PRODIGY System Block Diagram PRODIGY I System Block Diagram . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-392.2.3 PRODIGY I Peripheral Configuration Block Diagrams . . . 1-402.2.4 PRODIGY II System / Power Block Diagram . . . . . . . . . . 1-41

2.3 PRODIGY Fusing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-422.4 PRODIGY I (system numbers DF+11999 and lower) Single Board Controller . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-43

2.4.1 SBC Functions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-432.4.2 SBC Reset. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-432.4.3 SBC / Host PC Interface . . . . . . . . . . . . . . . . . . . . . . . . . . 1-44

2.5 PRODIGY II Combined Single Board Controller (cSBC) (systems DF+12000 and greater) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-45

2.5.1 cSBC System Architecture . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-452.5.2 cSBC Functions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-462.5.3 TRANS / LONG MOTOR Control and Status . . . . . . . . . . . . . 1-502.5.4 AGS ROLL . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-512.5.5 AGS DAC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-512.5.6 SCANNER RESET . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-522.5.7 GE-LUNAR Model 7861 X-ray Generator Errors. . . . . . . . . . . 1-532.5.8 DC FAIL. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-54

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2.5.9 DCA / AGS / BIAS DAC's . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-542.5.10 KV/mA DAC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-552.5.11 ARC/FIL DAC. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-552.5.12 PEAK DAC. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-552.5.13 MAX PLD Peripherals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-552.5.14 Interrupts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-562.5.15 MASTER RESET. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-562.5.16 SUICIDE RESET . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-572.5.17 MISC OUT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-572.5.18 MISC IN . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-572.5.19 Stepper Motor Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-582.5.20 OMI Input . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-592.5.21 Patient Positioners. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-592.5.22 Limit Switches . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-592.5.23 X-ray Source Control / Mechanical Interlocks . . . . . . . . . . . . 1-592.5.24 Shutter / Collimator Drive. . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-602.5.25 End of Exposure Alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-602.5.26 Panel LED's . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-602.5.27 HVPS Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-602.5.28 ADC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-612.5.29 mA Low Range . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-612.5.30 Detector Interface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-612.5.31 Communications Ports. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-622.5.32 Debug RS-232 Port . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-622.5.33 Diagnostic LED's . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-62

2.6 Power Distribution (PRODIGY II Systems DF+1200 and greater) . . 1-642.7 Tube Head and X-ray Insert . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-65

2.7.1 X-ray generation and Spectrum. . . . . . . . . . . . . . . . . . . . . 1-652.8 X-ray Generator (High Voltage Power Supply(ies)) . . . . . . . . . . . . . 1-662.9 MAX Board (PRODIGY I systems DF+11999 and lower only) . . . . . 1-67

2.9.1 MAX Board Function . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-672.9.2 Dedicated +28VDC power supply . . . . . . . . . . . . . . . . . . . 1-67

2.10 XORB Board (PRODIGY I Systems DF+11999 and lower only). . . 1-682.11 Detector Sub System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-69

2.11.1 Detector Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-692.11.2 Detector Operation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-692.11.3 Detector Daughter Board Overview. . . . . . . . . . . . . . . . . 1-702.11.4 Detector Daughter Board Operation . . . . . . . . . . . . . . . . 1-712.11.5 Detector Mother Board Overview. . . . . . . . . . . . . . . . . . . 1-722.11.6 Detector Mother Board Operation . . . . . . . . . . . . . . . . . . 1-72

2.12 FOINK (PRODIGY I Systems DF+11999 and lower only) . . . . . . . 1-742.12.1 FOINK Functions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-742.12.2 Motion Control and Detection . . . . . . . . . . . . . . . . . . . . . 1-74

2.13 Display Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-752.14 Audible X-RAY OFF Signal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-77

This document contains confidential or proprietary information of GE-Lunar Corp. Neither the document nor the information therein is to be reproduced, distributed, used or disclosed, either in whole or in part, except as specifically authorized by GE-Lunar Corp.

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2.15 X-Ray Collimator Subsystem . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-782.16 PRODIGY Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-79

2.16.1 Component specifications . . . . . . . . . . . . . . . . . . . . . . . . 1-792.16.2 Functional specifications . . . . . . . . . . . . . . . . . . . . . . . . . 1-792.16.3 Maximum scan area (long x transverse) . . . . . . . . . . . . . 1-792.16.4 Programs. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-802.16.5 Environmental specifications. . . . . . . . . . . . . . . . . . . . . . 1-802.16.6 Storage and transport environment. . . . . . . . . . . . . . . . . 1-812.16.7 X-ray generator (system no. DF+12000 and higher). . . . 1-812.16.8 X-ray generator (system no. DF+11999 and lower) . . . . 1-832.16.9 GE-LUNAR 8022 x-ray tube . . . . . . . . . . . . . . . . . . . . . . 1-852.16.10 GE-LUNAR 8743 x-ray tube head assembly (system no. DF+12000 and higher) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-862.16.11 LUNAR 6838 x-ray tube head assembly (system no. DF+11999 and lower) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-872.16.12 Laser specifications. . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-882.16.13 Compatible components . . . . . . . . . . . . . . . . . . . . . . . . 1-892.16.14 FDA Certified Components (USA Only) . . . . . . . . . . . . 1-89

2.17 Secondary Calibration / Daily QA . . . . . . . . . . . . . . . . . . . . . . . . . . 1-912.17.1 Secondary Calibration overview . . . . . . . . . . . . . . . . . . . 1-912.17.2 Starting the Daily QA (secondary calibration) . . . . . . . . . 1-91 Peak Test. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-922.17.3 Tests Performed in the Secondary Calibration . . . . . . . . 1-922.17.4 QA Database. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-94

Figure 2-9. PRODIGY System Exploded View of External Covers and associated hardware . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-33Figure 2-10. PRODIGY I NTC thermistor on the Primary Terminal Block1-35Figure 2-11. PRODIGY I Power Distribution Block Diagram . . . . . . . . . 1-38Figure 2-12. PRODIGY I (systems DF+11999 and lower) Block Diagram1-39Figure 2-13. PRODIGY I (Systems DF+11999 and lower) Peripheral Configuration Block Diagrams . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-40Figure 2-14. PRODIGY II System / Power Block Diagram . . . . . . . . . . . 1-41Figure 2-15. Detector Block Diagram . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-69Figure 2-16. Detector Daughter Board Operation . . . . . . . . . . . . . . . . . 1-71Figure 2-17. PRODIGY Detector Module . . . . . . . . . . . . . . . . . . . . . . . . 1-73Figure 2-18. PRODIGY display panel. . . . . . . . . . . . . . . . . . . . . . . . . . . 1-75Figure 2-19. Reference axis and target angles for tube head assembly 1-85Figure 2-20. Anode heating/cooling curves . . . . . . . . . . . . . . . . . . . . . . 1-86Figure 2-21. Cathode emission characteristics . . . . . . . . . . . . . . . . . . . 1-88Figure 2-22. X-ray tube assembly heating/cooling curves . . . . . . . . . . . 1-88Figure 2-23. PRODIGY Daily QA printout with expected values . . . . . . 1-95

Table 2-1. PRODIGY I (Systems DF+11999 and lower) Fuses . . . . . . . 1-42Table 2-2. PRODIGY II (systems DF+12000 and greater) Fuses. . . . . . 1-42Table 2-3. PRODIGY Component Specifications . . . . . . . . . . . . . . . . . . 1-79

This document contains confidential or proprietary information of GE-Lunar Corp. Neither the document nor the information therein is to be reproduced, distributed, used or disclosed, either in whole or in part, except as specifically authorized by GE-Lunar Corp.

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Table 2-4. X-ray generator technical information. . . . . . . . . . . . . . . . . . . 1-81Table 2-5. Table 4. X-ray generator technical information. . . . . . . . . . . . 1-83Table 2-6. LUNAR 8022 X-ray tube technical information. . . . . . . . . . . . 1-85Table 2-7. LUNAR 8743 x-ray tube assembly technical information. . . . 1-86Table 2-8. LUNAR 6838 x-ray tube assembly technical information. . . . 1-87Table 2-9. Laser specifications.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-88Table 2-10. FDA certified components (system no. DF+12000 and higher).1-89Table 2-11. FDA certified components (system no. DF+11999 and lower).1-90

This document contains confidential or proprietary information of GE-Lunar Corp. Neither the document nor the information therein is to be reproduced, distributed, used or disclosed, either in whole or in part, except as specifically authorized by GE-Lunar Corp.

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2.0 PRODIGY SystemThe PRODIGY includes the patient table and frame, X-ray tube, X-ray generator, detector, and arm. Its physical specifications are summarized in section 2.15.

The PRODIGY has a mechanical design with two separate motion systems that are capable of simultaneous operation. These are transverse, and longitudinal. Both motion systems are driven by stepper motors.

2.0.1 PRODIGY Electronics

The internal components of the scanner are safely secured by a number of panels, including the scanner's tabletop.

Figure 2-9. PRODIGY System Exploded View of External Covers and associated hardware

• The front and side panels are secured by screws from the inside.

• The rear panel is secured by screws from the outside.

• The table top is screwed down from the top.

Note: Primary Service access to the electronics of the scanner is through the table top.

This document contains confidential or proprietary information of GE-Lunar Corp. Neither the document nor the information therein is to be reproduced, distributed, used or disclosed, either in whole or in part, except as specifically authorized by GE-Lunar Corp.

PRODIGY Service Manual (Rev C - 2000) System Overview 2-33

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• The Detector electronics (in the scan arm) are secured by an upper and lower shroud, held in place by screws.

• Each metal panel is grounded to the electronics pan.

It is not usually necessary to remove the front and back panels for most service needs. However, if access is needed to the Front and Rear Longitudinal Carriages, these can be removed.

The back panel is secured by hex socket head-head screws and must be slid out of the way, for it is between the Arm Column and the frame.

If access is needed to the detector, Transverse Limit Switches or the other components mounted above in the arm, the covers of the arm must be removed.

• The upper scan arm shroud can be removed by loosening the two screws holding it in place (on the back of the arm column) and tipping it forward.

• The lower cover is held in place by four screws, two in the front and two in the back, be sure to remove the ground wire for the metal portion of the lower cover as well

This document contains confidential or proprietary information of GE-Lunar Corp. Neither the document nor the information therein is to be reproduced, distributed, used or disclosed, either in whole or in part, except as specifically authorized by GE-Lunar Corp.

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2.1 Electronics2.1.1 Cautions

PRODIGY electronics are static sensitive, take static control precautions before servicing scanner circuitry.

PRODIGY I electronics use Negative Temperature Coefficient (NTC) thermistors to limit the in rush current of the AC isolation transformer and the Detector Mother Board. These devices have a high resistance when cold and decrease in resistance when warm.

Figure 2-10. PRODIGY I NTC thermistor on the Primary Terminal Block

• A cool down period of 30 seconds is required before power is turned on on the system.

PRODIGY I ONLY: Failure to allow the system to “cool down” may cause the circuit breaker for the AC line to trip and / or the + 12VDC for the Detector Mother Board (DMB) will not come up to +12 VDC.

Note: The error log entry "DMB Power Cycle observed" is an indicator that the DC power to the Detector Mother Board has been interrupted and the system should be powered down for 30 seconds to restore power to the Detector Mother Board.

PRODIGY I ONLY: The NTC’s can get hot - they are located on the AC terminal block and on the DC terminal block be careful when servicing these areas of the scanner.

2.1.2 Electronics Pan

This document contains confidential or proprietary information of GE-Lunar Corp. Neither the document nor the information therein is to be reproduced, distributed, used or disclosed, either in whole or in part, except as specifically authorized by GE-Lunar Corp.

PRODIGY Service Manual (Rev C - 2000) System Overview 2-35

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The electronic components of the PRODIGY are mounted on the grounded Electronics Pan which is horizontally fastened inside the frame.

Note: Appendix 2 A contains a layout drawing of the Electronics Pan for PRODIGY I and PRODIGY II systems.

PRODIGY I Systems (System numbers DF+11999 and lower):

• There are four low-voltage linear DC power supplies (under 30VDC), and two high-voltage DC power supplies (to supply 76kV to the x-ray tube) on the pan.

• In addition to the power supplies, the electronics mounting chassis holds four printed circuit boards, a stepper motor controller, the audible alarm, an AC entrance/line filter/fuse holder, an isolation transformer and a terminal strip for AC power distribution to the Host PC and peripherals.

PRODIGY II Systems (System numbers DF+12000 and greater):

• There is one low-voltage DC switching power supply (under 30VDC), and one high-voltage DC power supply (x-ray generator - supplies 76kV to the x-ray tube) on the pan.

• In addition to the power supplies, the electronics mounting chassis holds one printed circuit board, a stepper motor controller, and an AC entrance/line filter/fuse holder.

2.1.3 Scan Arm

• The scan arm contains one high-voltage power supply (1000VDC / +12 VDC input) is located in the upper arm near the X-ray detector and provides power to the Detector Array.

• The scan arm also houses the detector and 5 associated printed circuit boards, and a stepper motor contoller.

2.1.4 Power specifications

Leakage current

• Total System with Isolation Transformer: <100 microamperes.

• Scanner Table alone: <100 microamperes.

Scanner input power

• PRODIGY I ONLY: The scanner has 12 different nominal inputs: 100, 110, 115, 120, 125, 127, 200, 220, 230, 240, 250, and 254 VAC. During installation, the scanner is configured for the nominal input which best matches the voltage on site.

This document contains confidential or proprietary information of GE-Lunar Corp. Neither the document nor the information therein is to be reproduced, distributed, used or disclosed, either in whole or in part, except as specifically authorized by GE-Lunar Corp.

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• PRODIGY II ONLY: The scanner can accept any AC input between 100 and 254 VAC.

• Voltage may fluctuate ±10% from the nominal value without a loss of scanner performance.

• The nominal input (range of inputs) can be found on the system label.

• The rated power input is 1500 VA.

• The input power must meet IEEE 519-1992 for power quality and total harmonic distortion (THD <5%).

Scanner output power (PRODIGY I system numbers DF+11999 and lower only)

• The scanner has 3 different nominal outputs: 100, 120, 240 VAC.

• The nominal voltage output of the scanner is shown on the system label.

• The computer and all peripherals which use the scanner output power must be rated for this voltage.

• The maximum power output is 400 VA.

This document contains confidential or proprietary information of GE-Lunar Corp. Neither the document nor the information therein is to be reproduced, distributed, used or disclosed, either in whole or in part, except as specifically authorized by GE-Lunar Corp.

PRODIGY Service Manual (Rev C - 2000) System Overview 2-37

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2.2 PRODIGY Block DiagramsThe block diagrams for the PRODIGY system follow:

2.2.1 PRODIGY I (System numbers DF+11999 and lower) Power Distribution Block Diagram (AC entrance)

Figure 2-11. PRODIGY I Power Distribution Block Diagram

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2.2.2 PRODIGY System Block Diagram PRODIGY I System Block Diagram

Figure 2-12. PRODIGY I (systems DF+11999 and lower) Block Diagram

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PRODIGY Service Manual (Rev C - 2000) System Overview 2-39

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2.2.3 PRODIGY I Peripheral Configuration Block Diagrams

Figure 2-13. PRODIGY I (Systems DF+11999 and lower) Peripheral Configuration Block Diagrams

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2.2.4 PRODIGY II System / Power Block Diagram

Figure 2-14. PRODIGY II System / Power Block Diagram

This document contains confidential or proprietary information of GE-Lunar Corp. Neither the document nor the information therein is to be reproduced, distributed, used or disclosed, either in whole or in part, except as specifically authorized by GE-Lunar Corp.

PRODIGY Service Manual (Rev C - 2000) System Overview 2-41

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2.3 PRODIGY Fusing

All fuses are 250V, low breaking capacity (25A minimum)

Table 2-1. PRODIGY I (Systems DF+11999 and lower) Fuses

PRODIGY II (systems DF+12000 and greater) Fuses

All fuses are 250V, low breaking capacity (25A minimum)

Table 2-2. PRODIGY II (systems DF+12000 and greater) Fuses

PRODIGY I (system numbers DF+11999 and lower) Fuses

Fuse Rating Type*

F1 (Computer AC) T 2.0 AL 5x20MM

F2 (Computer AC) T 2.0 AL 5x20MM

F3 (+5, +/-12 VDC PS (1)) T 1.25 AL 5x20MM

F4 (+5, +/-12 VDC PS (2)) T 1.25 AL 5x20MM

F5 (+26VDC PS) T 2.5 AL 5x20MM

F6 (+28VDC PS) T 0.63 AL 5x20MM

F7 (+5, +/-12VDC PS (1)) T 1.25 AL 5x20MM

F8 (+5, +/-12VDC PS (2)) T 1.25 AL 5x20MM

F9 (+26 VDC PS) T 2.5 AL 5x20MM

F10 (+28 VDC PS) T 0.63 AL 5x20MM

MAX PCB F1 F 0.5 AL 1/4x1 1/4 in.

Fuse Rating Type

Condor PS F1 F3.15 AH 5x20 mm

Condor PS F2 F3.15 AH 5x20 mm

COndor PS F3 F3.15 AH 5x20 mm

This document contains confidential or proprietary information of GE-Lunar Corp. Neither the document nor the information therein is to be reproduced, distributed, used or disclosed, either in whole or in part, except as specifically authorized by GE-Lunar Corp.

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2.4 PRODIGY I (system numbers DF+11999 and lower) Single Board Controller

2.4.1 SBC Functions

The microprocessor-based Single Board Controller (SBC) provides overall operation and control of the scan table.

Control Functions

• Control of x-ray source power supplies, and shutter / collimator in a fail safe manner.

• Provides control signals for two external stepper motor drives (Centent) to scan patient in a fail safe manner and senses limit switch actuation at the limits of travel (via FOINK see 2.11).

• Controls the detector array (communicates with the Detector Mother Board, section 2.10.2).

• Responds to external scanner failure signals (interrupts generated by SBC, FOINK see 2.11, and Detector Mother Board see 2.10).

Communication

• Communicates with PC host via an optically isolated RS-422 interface.

• Collects data from the detector array.

2.4.2 SBC Reset

All SBC circuitry resets when the microprocessor resets. This is done during power up, and can also be done over the communication port (via the host), through connections to other circuit boards (especially the Detector Mother Board, as a fail-safe shutdown), the by pressing the reset button on the SBC, by pressing the Emergency Stop Button on the arm, or when a fault is detected by the SBC or the FOINK (section 2.11.1).

Error Conditions Sensed by the SBC:

• Loss of Communications with the Detector Mother Board (DMB).

• Loss of Communications with the Host PC.

• Limit Switch tripped when shutter is open.

• Limit Switch depressed when commands are being sent.

• Failure in x-ray source kV programming

This document contains confidential or proprietary information of GE-Lunar Corp. Neither the document nor the information therein is to be reproduced, distributed, used or disclosed, either in whole or in part, except as specifically authorized by GE-Lunar Corp.

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• Interrupt sent by FOINK

The DMB will reset the SBC if it detects an error.

Error Conditions of the DMB sensed by the SBC:

• PLD programming failure

• Loss of +5 or +12 VDC

• Loss of Communications with SBC

• Corrupt FIRMWARE

• FLASH RAM Failure

• DTR Reset button on the DMB is pressed

2.4.3 SBC / Host PC Interface

The SBC communicates with the Host PC via an RS-422 interface. This is a serial connection capable of transmitting more data than a standard RS-232 port. As it is not a standard serial port a RS-485 card must be installed into one of the Host PCs expansion slots and the port must be configured correctly for the PRODIGY to operate correctly (see DXPC2000 chapter 5 appendices).

This document contains confidential or proprietary information of GE-Lunar Corp. Neither the document nor the information therein is to be reproduced, distributed, used or disclosed, either in whole or in part, except as specifically authorized by GE-Lunar Corp.

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2.5 PRODIGY II Combined Single Board Controller (cSBC) (systems DF+12000 and greater)

The cSBC printed wiring board (PWB) is an eight layer rectangular board measuring 7.400" x 8.100". The PWB is mounted in the via four mounting holes located 1/4" from each corner and 2 additional interior mounting holes. The components are primarily surface mount, with board connectors, headers and a few single-style ICs being the only exceptions.

Four layers were dedicated for routing layers. Sensitive signals were noted and routed manually and isolated from more powerful signals to reduce signal interference and crosstalk on the same routing layer. The main power and ground planes were stacked adjacently on the central inner layers to increase inter-planar capacitance thus reducing ground bounce and power supply noise. Traces on the top and bottom layers were kept as short as reasonably possible and tapped down to an internal trace layer through vias.

Component placement is arranged to separate analog from digital circuitry. Further isolation was achieved by segmenting the power and ground planes into analog and digital sections and denying analog/digital plane overlap, thus preventing digital noise from coupling into the analog section. All scanner control I/O is run via connectors located on the +24V plane section. The +24V plane is fully optically isolated from both the analog and digital plane areas to prevent motor noise from coupling into the analog section, to prevent DC switching noise from radiating on scanner cables, and to prevent ESD presented at cable inputs from reaching the digital IC's.

2.5.1 cSBC System ArchitectureThe cSBC employs an Intel 80C251 micro-controller as its processor. This processor provides 1K of on-board RAM and no on-board ROM. The controller is clocked at 16 MHz using a crystal.

cSBC Memory Space

The cSBC is designed to support a JEDEC-standard, non-volatile FLASH memory device up to 512K x 8 bits in size for code and fixed data. The board supports either 128K or 512K SRAM memory device as needed for program volatile memory. Complete address decoding is provided via the MAX PLD, the CBSC bus master, allowing the address space to be arbitrary and changed via the PLD code. The 80251 can address four 64K segments, referred to as 0x00, 0x01, 0xFE and 0xFF as per Intel literature. The firmware has the ability to map any FLASH or SRAM segment to any CPU segment via SFR’s in the MAX PLD.

FLASH RAM

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At startup the CPU executes the boots code which programs the FLEX PLD and then maps in either NT or Prodigy runtime firmware as appropriate based on the most significant bit of the CCA REV register. To switch from boot code to run code the firmware jumps to SRAM and executes a code snippet which pages the boot code out of 0xFF and the desired firmware into 0xFF. The snippet then jumps from SRAM back to 0xFF to execute the firmware. A boot jumper, JP4 is provided to optionally force the CPU to remain in the boot code. When the boot jumper is installed the boot code runs the host port at 115.2KB.

SRAM

The cSBC contains a single 128K x 8 bit SRAM which provides read/write memory. The SRAM's segments are arbitrarily mapped to any CPU segment by the CPU mapping registers.

2.5.2 cSBC Functions

The microprocessor-based Single Board Controller (cSBC) provides overall operation and control of the scan table.

FLEX PLD Peripherals

The majority of scanner related programmable logic functionality is contained in the FLEX PLD, an Altera EPF6024AQC208-3 device. Device programming is handled exclusively by the CPU. On each cold boot the CPU reprograms the FLEX devices from an image stored in it's FLASH. As such a firmware download of a new FLEX image is required to permanently upgrade the PLD code.

The functional components of the programmable logic are discussed in the following subsections. Polarity of operation can be inferred from bit names and use of preceding slash for inverted logic bits.

Note that ports A-F are reloaded with default values at time of CPU reset and remain in the default state until SCANNER_RESET has been cleared and new values are written by the firmware. Defaults for port F and all other registers are invoked at power up only.

PORT A

Bit Name R/W

Def. Description

0 trans_enable R/W 0 Transverse motor enable – low blocks trans motor pulses and forces Centent drive to standby current level.

1 /trans_fwd R/W 0 Transverse motor direction control.

2 /shutter_open_ctrl R/W 1 Shutter solenoid control.

3 trans_lsw_override R/W 0 Transverse limit switch override – prevent limit switch contact from blocking step pulses at hardware level.

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4 long_enable R/W 0 Longitudinal motor enable – low blocks trans motor pulses and forces Centent drive to standby current level.

5 /long_fwd R/W 0 Longitudinal motor direction control.

6 long_lsw_override R/W 0 Longitudinal limit switch override – prevent limit switch contact from blocking step pulses at hardware level

7 /collimator_open_ctrl R/W 1 Collimator solenoid control.

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PORT B

PORT C

Bit Name R/W

Def. Description

0 /trans_front_lsw R N/A Transverse front limit switch position.

1 /trans_back_lsw R N/A Transverse back limit switch position.

2 /long_foot_lsw R N/A Longitudinal foot limit switch position.

3 /long_head_lsw R N/A Longitudinal head limit switch position.

4 trans_count_eq[0] R N/A Set when transverse step counter equals zero.

5 long_count_eq[0] R N/A Set when longitudinal step counter equals zero.

6 /shutter_open_sense R N/A Shutter limit switch position.

7 /collimator_open_sense R N/A Collimator limit switch position.

Bit Name R/W

Def. Description

0 /long_rev_pos R N/A Patient positioner (joystick) input.

1 /long_fwd_pos R N/A Patient positioner (joystick) input.

2 /trans_rev_pos R N/A Patient positioner (joystick) input.

3 /trans_fwd_pos R N/A Patient positioner (joystick) input.

4 /hvps_ac_relay R/W 1 Enable AC power to X-ray HVPS.

5 /motor_fail_enable R/W 1 Arm logic to shutdown scanner if OMI inputs not sensed.

6 ags_enable R/W 0 Enable detector automatic gain control feedback circuit.

7 /motor_power R/W 1 Enable 24VDC to the stepper motor drives (a.k.a. Centents).

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PORT D

PORT E

Bit Name R/W

Def. Description

0 flex_max_i/o_[0] R/W 0 Output signal to MAX PLD (diagnostic use only).

1 flex_max_i/o_[1] R/W 0 Output signal to MAX PLD (diagnostic use only).

2 flex_max_i/o_[2] R/W 0 Output signal to MAX PLD (diagnostic use only).

3 flex_max_i/o_[3] R/W 0 Output signal to MAX PLD (diagnostic use only).

4 flex_diag_3 R/W 0 Firmware controlled diagnostic LED.

5 pit_enable R/W 0 Enable Programmable Interval Timer output pulses.

6 flex_diag_1 R/W 1 Firmware controlled diagnostic LED.

7 /laser_on R/W 1 Patient locator laser control.

Bit Name R/W

Def. Description

0 low_range_dac R/W 0 Switches mA DAC from 2.048V to 0.500V reference.

1 trans_motor_accel R/W 0 Enables motor interrupt on every micro step.

2 low_range_adc R/W 0 Switches ADC from 5.000V to 0.500V reference.

3 long_motor_accel R/W 0 Enables motor interrupt on every micro step.

4 hvps_vendor_id R N/A For 7681 supply, 0 = Spellman, 1 = Bertan.

5 iq_hvps R N/A Set by resistor placement to indicate 0311/0312 supplies.

6 /hvps_enable_status R N/A Enable status monitor from 7681 supply.

7 /power_up R N/A Set to indicate cold boot.

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PORT F

PORT G

2.5.3 TRANS / LONG MOTOR Control and Status

Dual axis stepper motor control is provided entirely by the FLEX PLD. To make a typical move the firmware loads a starting velocity into the 16 bit VELOCITY register, the total number of steps for the move into the 16 bit TARGET register, and step at which to next interrupt the CPU into the 16 bit STEP register. Velocity is in terms of periods of the 2.0MHz fundamental clock per micro step pulse to the stepper drive. The drives provide 10 micro steps per full step. The firmware can track move status by reading the 16 bit READ register.

Bit Name R/W

Def. Description

0 /motion_fail_enable R/W 1 Arm scanner shutdown if OMI pulses w/o step pulses.

1 long_motor_fail_axis R/W 0 Motor fail circuitry axis control, clear for transverse.

2 /hvps_enable R/W 1 Enable output to 7681 supply.

3 flex_diag_2 R/W 0 Firmware controlled diagnostic LED.

4 /arm_estop_sense R N/A Emergency stop sense bit.

5 spare_jmp_[1] R N/A Unused input, resistor or jumper selectable on CCA.

6 spare_jmp_[0] R N/A Unused input, resistor or jumper selectable on CCA.

7 cpu_p1_2 R N/A Firmware controlled diagnostic LED.

Bit Name R/W

Def. Description

0 adc_mux_[0] R/W 0 ADC analog MUX input selection control bit.

1 adc_mux_[1] R/W 0 ADC analog MUX input selection control bit.

2 adc_mux_[2] R/W 0 ADC analog MUX input selection control bit.

3 adc_mux_[3] R/W 0 ADC analog MUX input selection control bit.

4 adc_mux_enable R/W 0 ADC MUX output enable control.

5 8ms_clock R/W 0 Clock output provided to MAX PLD.

6 unused N/A N/A For expansion.

7 unused N/A N/A For expansion.

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As part of the setup for a move the host and/or firmware must enable the motors via the /motor_power, trans_enable, and long_enable outputs and setup the trans_lsw_override, long_lsw_override, /motion_fail_enable, /motor_fail_enable, and long_motor_fail_axis outputs as desired. If the system is in scanner reset for any reason the FLEX PLD will over-ride the /motor_power output and prevent 24V power from reaching the motor drives. Addressing for the motor control interface is provided below.

2.5.4 AGS ROLL

This is a read only 8 bit register which returns the count of AGS roll-over events since the previous read of the register. The AGS roll counter is reset on read only - it is not tied to the PIT's sample clock.

2.5.5 AGS DAC

This port provides R/W access to the AGS circuit's 8 bit U/D counter. The counter is tied via a dedicated 8 bit bus to the AGS DAC. The DAC's analog voltage is tied to the gain control input of the variable gain amplifier (VGA) used to control gain of the detector input signal. As such the firmware can read this counter to determine the current DAC voltage level and hence gain level. If ags_enable is low this port gives the firmware direct control of the AGS DAC as a parallel R/W device. If ags_enable is high, the firmware can write to the port but the DAC will continue to respond to UP/DOWN requests from the AGS DCA circuitry and hence quickly return to the AGS current operating voltage.

HE/LE COUNTERS

These read only ports provide access to the 16 bit event counters which are incremented each time the DCA circuitry detects an input pulse within the HE or LE windows (as defined by the LEL, LEH, HEL, and HEH DAC settings). These counters are read in two 8 bit bus cycles, MSB then LSB. The event counters themselves consist of a counting element and a bus element. On the rising edge on the PIT output pulse the counting elements are latched to the bus element. The PIT output is also tied to CPU external INT 1 and as such the firmware interrupt handler then has until the next rising PIT edge to read the counters before the bus elements are latched over with the next sample count and data is lost.

PIT MSB/LSB

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The PLD provides a programmable interval timer (PIT) to the CPU. The PLD prescales it's input clock to generate a PIT base clock of 100KHz. The CPU writes a 2 byte word to the PIT reload register MSB/LSB. The CPU then raises the pit_enable bit to start the timer. In response to the rising edge on the pit_enable, the PIT loads the reload word into it's counting element and begins counting down. When the count rolls under the PIT asserts /SAMPLE_INT, reloads the counting element, and begins another count down sequence. The /SAMPLE_INT line is tied internally to the HE and LE event counters and causes a synchronous latch of both counting elements. The /SAMPLE_INT line is also tied to the processor's 2nd external interrupt line, /INT1. The CPU interrupt handler reads the latched event counters and ships the data to the host.

2.5.6 SCANNER RESET

The scanner reset register is used to provide failsafe shutdown operation of the scanner. A falling edge on any of the inputs to this register will latch the current value of the register and drop the /SCAN_FAIL_ANY output. The MAX PLD latches the master reset register and raises CPU_RESET in response to the falling edge on /SCAN_FAIL_ANY. The MAX PLD also provides SCANNER_RESET as the logical OR of CPU_RESET and!/SCAN_FAIL_ANY. The FLEX PLD uses it's SCANNER_RESET input as the enable bit to the tri-state buffers used to drive all safety critical output lines including shutter control, HVPS relay control, motor relay control, etc. As such the scanner is locked into a fail-safe mode whenever SCANNER_RESET is asserted.

The MAX's master reset register will remain latched until the next rising edge on the HOST_RTS input. When the cSBC is latched into reset by a scanner error it will remain in CPU reset until the host drops the RTS line and re-asserts it. It will remain in scanner reset until the CPU reads the scanner reset register following the next raising edge of the RTS line at which the condition causing the /SCAN_FAIL_ANY has been cleared. The firmware passes the value of the reset registers to the host to allowing the host to display appropriate error messages to the operator. The host will be unable to perform any scanner related operations until the SCANNER_RESET has been cleared. Red diagnostic LED's (see 2.5.33) are provided for both scanner and CPU reset lines. The CPU reset line is tied to the host CTS output such that the host sees a CTS event when the cSBC enters CPU reset. The host code provides a CTS event handler which reads the reset registers and prompts the user accordingly.

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The firmware can also initiate a reset sequence in response to fatal error conditions by writing a 'death code' to the suicide reset register. Resets can also be initiated by the manual push button on the cSBC and by a low 5VDC power condition as sensed by the MAX705 supervisor. The scanner register is also latched at the end of read cycles such that current status can be ascertained by a double read. A bit map of the scanner reset register is provided below

2.5.7 GE-LUNAR Model 7861 X-ray Generator Errors

The HVPS error register is used to monitor the status of the 7681 X-ray source HVPS. If the register value is not equal to 0xF when /hvps_enable is low, the FLEX will raise the HVPS_ERROR_INT output to the MAX PLD. The MAX PLD latches this into the IIR register and issues an interrupt to the CPU. As such status of the HVPS is monitored when the unit is enabled. The handler for HVPS interrupt reads this register to determine the cause of the interrupt. The HVPS register is also latched at the end of read cycles such that current status can be ascertained by a double read. A bit map of the register is provided below.

Bit Name R/W

Def. Description

0 /thermostat_open_sense

R N/A Tube head thermostat over temperature.

1 /external_estop_sense R N/A Emergency stop input from external options block.

2 /dc_power_fail R N/A Loss of one or more of +5VDC,+12VDC,-12VDC, or +24VDC.

3 /long_motor_fail R N/A Motor failure detected on longitudinal axis.

4 /trans_motor_fail R N/A Motor failure detected on transverse axis.

5 /dmb_error R N/A DMB dropped it’s CTS indicating a DMB reset event.

6 /motion_fail R N/A OMI pulses detected without step pulse (manual arm motion).

7 /watchdog_reset R N/A Watchdog time-out indicates firmware crash.

Bit Name R/W

Def. Description

0 /hvps_error_0 R N/A Error code bit from 7681 supply.

1 /hvps_error_1 R N/A Error code bit from 7681 supply.

2 /hvps_error_2 R N/A Error code bit from 7681 supply.

3 hvps_enable_status R N/A Set when /hvps_enable == /hvps_eanble_status

4 Unused N/A N/A Expansion room.

5 Unused N/A N/A Expansion room.

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2.5.8 DC FAIL

The DC fail error register latches the status of the DC power monitors at the time of reset. If scanner reset code indicates /dc_power_fail the firmware can read this register to identify the specific DC source failure. The register is also latched at the end of read cycles such that current status can be ascertained by a double read.

2.5.9 DCA / AGS / BIAS DAC's

The cSBC uses a single 10 bit octal DAC, the Linear Technology LTC1660, to generate the AGS and DAC window reference voltages and the bias program voltage. The DAC utilizes a serial interface and as such is not accessed with a traditional CPU write cycle. To load the device the firmware writes to the DAC address listed above, in response to which the MAX drops the /CS line to the device. The firmware then manipulates the local serial bus clock and data lines to load the DAC setting. The desired DAC channel address in encoded into the first 4 bits of the output data word. A read is then made to the DAC address, in response to which the MAX raises the /CS line. See device data sheet and analog section below for further DAC details.

6 Unused N/A N/A Expansion room.

7 Unused N/A N/A Expansion room.

Bit Name R/W

Def. Description

0 /plus_scanner_fail R N/A Loss of +24V power input.

1 /plus_analog_fail R N/A Loss of +12V power input.

2 /minus_analog_fail R N/A Loss of -12V power input.

3 Unused N/A N/A Expansion room.

4 Unused N/A N/A Expansion room.

5 Unused N/A N/A Expansion room.

6 Unused N/A N/A Expansion room.

7 Unused N/A N/A Expansion room.

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2.5.10 KV/mA DAC

The cSBC uses a single 12 bit dual DAC, the Linear Technology LTC1454, to generate the HVPS kV and mA program voltages. The DAC utilizes a serial interface and as such is not accessed with a traditional CPU write cycle. To load the device the firmware writes to the DAC address listed above, in response to which the MAX drops the /CS line to the device. The firmware then manipulates the local serial bus clock and data lines to load the DAC setting. Both DAC channels must be written together, CHA (kV) first followed by CHB (mA) in a 24 bit stream packet. A read is then made to the DAC address, in response to which the MAX raises the /CS line. See device data sheet and analog section below for further DAC details.

2.5.11 ARC/FIL DAC

The cSBC uses a single 10 bit dual DAC, the Linear Technology LTC1661, to generate the HVPS filament limit and arc detect threshold voltages. The DAC utilizes a serial interface and as such is not accessed with a traditional CPU write cycle. To load the device the firmware writes to the DAC address listed above, in response to which the MAX drops the /CS line to the device. The firmware then manipulates the local serial bus clock and data lines to load the DAC setting. The desired DAC channel address in encoded into the first 4 bits of the output data word. A read is then made to the DAC address, in response to which the MAX raises the /CS line. See device data sheet and analog section below for further DAC details.

2.5.12 PEAK DAC

The cSBC uses a 12 bit DAC, the Linear Technology LTC8043, to generate the detector peak gain voltage. The DAC utilizes a serial interface and as such is not accessed with a traditional CPU write cycle. To load the device the firmware manipulates the local serial bus clock and data lines to output load the DAC setting and then performs a write/read cycle to the DAC address listed above to pulse the DAC's load line low. See device data sheet and analog section below for further DAC details.

2.5.13 MAX PLD Peripherals

The programmable logic section is based on an Altera MAX EPM7128STC100-15 device. The configuration pins for this device are taken to a JTAG style 10 pin header to allow for in-circuit programming of the device from the Altera Byte-Blaster. The MAX device is FLASH based (non-volatile) and is programmed at the time of CCA assembly. The functional components of the programmable logic are discussed in the following subsections.

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2.5.14 Interrupts

The CPU's interrupt capacity is effectively increased by running several interrupt signals to a register in the MAX PLD and tying the register output to the CPU external INT 0 input. The firmware interrupt handler for INT 0 then reads this register to identify the source of the interrupt and handles it accordingly. The firmware then writes a bit masked '1' back to the IIR to clear the bit of the interrupt it has serviced (the R/C in the table stands for READ/CLEAR).

2.5.15 MASTER RESET

The master reset register will force a CPU and scanner reset condition on the falling edge of any of its listed inputs. The contents of the register will be latched at the time of reset such that when the CPU next comes out of reset the firmware can read the register to determine what caused the preceding reset and report the appropriate code to the host. If the reset was cause by the CPU_RST_WR input, the suicide reset register contains the specific error code. If the reset was cause by the /SCAN_FAIL_ANY input, the scanner reset register contains the specific error code.

The CPU and scanner resets will remain latched until the next rising edge of the RTS input. At this time the CPU reset will be cleared if /POWER_RESET bit is not asserted and the scanner reset will be cleared if /SCAN_FAIL_ANY is high.

Bit Name R/W

Def. Description

0 HOST_UART_INT R/C N/A Host UART interrupt.

1 DEBUG_UART_INT R/C N/A Debug UART interrupt.

2 DMB_UART_INT R/C N/A DMB UART interrupt.

3 HVPS_ERROR_INT R/C N/A HVPS error interrupt.

4 8mS_CLOCK R/C N/A 8ms clock tick interrupt from FLEX PLD.

5 POWER_FAIL_INT R/C N/A Power down pending in 5ms interrupt from DC supply.

6 Unused N/A N/A Expansion room.

7 Unused N/A N/A Expansion room.

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2.5.16 SUICIDE RESET

The CPU Reset SFR is a byte register into which the CPU can write a failure code. In response to the write the MAX PLD will store the failure code and assert the CPU_RESET line. The CPU_RESET line will be released on the next rising edge of the host RTS, at which time the CPU will be able to read the bit code from this SFR to determine the cause of the previous reset.

2.5.17 MISC OUT

The misc. output register is used to control the misc. output functions listed in the following table.

Bit Name R/W

Def. Description

0 /POWER_RESET R N/A MAX705 supervisor detects VCC < 4.65V.

1 /HOST_RTS R N/A RTS reset request from host via comm line.

2 /MANUAL_RESET R N/A Push button pressed.

3 Unused R N/A Expansion room, reads as ‘1’.

4 Unused R N/A Expansion room, reads as ‘1’.

5 Unused R N/A Expansion room, reads as ‘1’.

6 CPU_RST_WR R N/A Write to the suicide register, read suicide reg for error code.

7 /SCAN_FAIL_ANY R N/A Scanner reset register latched, read scanner reg for error code.

Bit Name R/W

Def. Description

0 Unused N/A N/A Expansion room.

1 MAX DIAG_2 R/W 0 Firmware controlled diagnostic LED.

2 DMB HWPT R/W 0 Enable direct connect of host and DMB XCVR’s, bypassing UART’s, for maximized scan data bandwidth DMB to host.

3 RESET OVERRIDE R/W 1 Enable override of CPU_RESET signal. Set to 1 on power-up such that firmware can load the FLEX PLD at power-up regardless of the host RTS state.

4 Unused N/A N/A Expansion room.

5 Unused N/A N/A Expansion room.

6 Unused N/A N/A Expansion room.

7 Unused N/A N/A Expansion room.

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2.5.18 MISC IN

The misc. output register is used to control the misc input functions listed in the following table

2.5.19 Stepper Motor ControlThe stepper motors use the same interface design as used on IQ and Prodigy. The FET exhibits a lower voltage drop and hence provides more available power at the drives for a given source voltage - essentially recovering the voltage lost in dropping the DC supply from the 26V used on IQ/Prodigy to the 24V which is readily available in commercial switchers. Diodes are placed in series on the Centent power lines to prevent back EMF generated when the arm is moved manually from reaching the 24V planes and damaging the cSBC. A dual FET circuit is used to minimize the voltage drop on the 24V plane due to in-rush current when the motors are enabled. A circuit in the FLEX implements a 2 stage turn on when the firmware lowers /motor_enable. Q15 is enabled first to provide 24V to the Centents through R381 and R384, thus limiting the in-rush current. After the current pulse has stabilized Q14 is enabled to bypass the inrush limiting resistors. Q15 is then disabled and the motors are at full power. An PTC is provided on the source of Q15 such that the current limiting resistors will not be smoked if Q15 is inadvertently left enabled.

Bit Name R/W

Def. Description

0 BOOT JUMPER R N/A JP4, placed to force firmware to remain in boot code.

1 CPU_P1_2 R N/A Input from CPU port 1, pin 2 (diagnostic use only).

2 Unused N/A N/A Expansion room.

3 Unused N/A N/A Expansion room.

4 Unused N/A N/A Expansion room.

5 Unused N/A N/A Expansion room.

6 Unused N/A N/A Expansion room.

7 Unused N/A N/A Expansion room.

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2.5.20 OMI InputThe optical motion interrupt (OMI) sub-system connects to the transverse and longitudinal OMI CCA's. The OMI CCA's are located on the far end (the gear end farthest from the motor) of each drive axis. When the axis is in motion a small toothed wheel spins through the OMI opto's beam and pulses are sensed back on the cSBC. In this manner the system can sense a drive circuit, motor, or belt failure which might otherwise result is a concentrated exposure point during a patient scan. The OMI inputs are similar to those used on the DPX-IQ. 74LS14's are added for hysteresis which provides a clean direct interface to the PLD. As on Prodigy, logic in the FLEX PLD is used to qualify the CH A and CH B inputs into a single 'valid motion' output. Based on the phases of the square wave inputs on CH's A&B, the FLEX is able to sense a change in direction. The circuit provides hysteresis to reject false motion inputs resulting from scanner vibration when a wheel edge stops in the center of the opto beam at the end of a move.

2.5.21 Patient PositionersFour optically isolated inputs are provided for patient positioning. These are used by the firmware to implement a joystick mode which is used in conjunction with the laser to position the X-ray beam as desired over the patient immediately prior to a scan. 74LS14 inverters are used to provide hysteresis and isolate the FLEX PLD inputs from the slow rise times of the opto output signals.

2.5.22 Limit SwitchesFour optically isolated inputs are provided for limit switches. These are used by the firmware to define the transverse and longitudinal table limits. 74LS14 inverters are used to provide hysteresis and isolate the FLEX PLD inputs from the slow rise times of the opto output signals.

2.5.23 X-ray Source Control / Mechanical InterlocksThe cSBC is designed such that a high on the scanner reset net disables all scanner functionality and assures a know, fail safe, state. All scanner control outputs are driven by the FLEX PLD. The FLEX outputs drive the low side of a PS2501 opto coupler emitter. The far side of all these opto circuits are configured such that the opto has to be energized for the scanner function to be active. As such the FLEX has to sink current to energize the opto and activate the desired scanner function. Internally the FLEX code defines these outputs as tri-state buffers, each of which has their enable line tied to the scanner reset net. As such a scanner reset will force all these FLEX scanner outputs to a high impedance state, de-energizing the opto's and disabling the scanner.

The FLEX device is SRAM based and hence must be reprogrammed by the CPU at power up. When the device is not programmed all I/O pins default to the high impedance state. As such the scanner will also be in a fail safe state when the FLEX is not programmed. The CPU port 1, pin 2 also runs directly to the FLEX's ENABLE pin.

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The cSBC provide a failsafe mechanism independent of the programmable logic via the +5V_IO circuit. If one or more of either the E-stop, external E-stop, or tube thermostat is open, the FET driving the +5V_IO net from the +5VDC plane will be disabled. The +5V_IO net provides power to the emitter anode of all opto's which drive critical scanner functions. As such the scanner will enter a failsafe state in response to these mechanical interlocks, even in the event of a PLD device failure. The +5V_IO FET will also be disabled by either a HOST_RTS or CPU_RESET.

2.5.24 Shutter / Collimator DriveThe shutter and collimator solenoid drive circuits are the same as that used on Prodigy I. The FLEX drives an isolation opto which in turn switches a pair of FET's to control solenoid current. The first FET is used for an initial 'hard hit' on open commands. It presents 24V directly to the solenoid for several hundred msec's, resulting in a large initial current pulse to the solenoid. The second FET provides the 'hold' current through a pair of current limiting power resistors. The hold FET is tied directly to the /shutter_open_ctrl bit. Note that the collimator drive is populated only for NT-A and IQ upgrades which use the old style IQ collimator assembly. The nominal values of the power resistors is changed between the NT and Prodigy II BOM's to support both the traditional linear solenoid of IQ, and the rotary solenoid of Prodigy. A jumper or DNP'd resistor is used to drive the IQ_SHUTTER line to the FLEX such that both mechanical and optical shutter limit switches are supported.

2.5.25 End of Exposure AlarmAn on-board end of exposure alarm is provided. The alarm chosen is the board mount equivalent of that used on Prodigy I.

2.5.26 Panel LED's

The 4 panel LED's, power on, X-ray on, source exposed, and laser on, are all driven PS2501-2 opto's through 750R0 / 1W current limiting resistors.

2.5.27 HVPS Control

The HVPS analog control interface is designed to provide maximum performance at minimum cost. A single, 16 channel multiplexed, 16 bit, high accuracy, ADC is used in conjunction with several lower cost, lower bit resolution DAC's. Absolute accuracy of DAC's is poor but errors are calibrated out by the firmware which monitors the actual DAC output via the ADC. In this scenario DAC integral non-linearity (INL) specs are not important, sufficient differential non-linearity (DNL) is all that is required. Serial DAC's and ADC's are chosen to conserve board space and simplify routing. Serial parts are typically also lower cost as their maximum bandwidth is limited by the serial baud rate.

The HVPS AC is enabled via a relay controlled by the cSBC. The line is primarially used to disable the HVPS by removing the AC to the HVPS via the relay. AC Power to the HVPS can be left on for up to one hour after generation of x-rays to prevent AC cycling between concurrent scans.

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A jumper and/or DNP'd resistor pad is provide to drive the IQ_HVPS line, which the firmware reads to determine which HVPS it is intended to operate. The PWB provides lemo style connector pads for use with the traditional 0311/0312 HVPS and MAX CCA. For the 7681 HVPS the lemos are DNP'd and a single DB-25 connector is used to control the HVPS. Tranzorb pads are provide on the PWB and are expected to be populated only if deemed necessary by EMC testing. An opto bank is also provided to support the digital interface to the 7681. See Lunar dwg 7681-SPC for details.

2.5.28 ADCThe Burr Brown ADS8320 16 bit, serial, single channel ADC was chosen for the cSBC for its high resolution, and excellent accuracy.

An Analog devices AD586 +5V voltage reference is used. The part was selected for it low noise and high accuracy

Overall the ADC and reference give the cSBC +/-5mV analog accuracy 11.2 DAC's

A single LTC1454 12 bit, serial, dual channel, DAC is used to provide the kV and mA program voltages. The part was chosen for it low cost, ready availability at national distributors, and excellent DNL specifications. The DAC is used in the x2 configuration such that the full scale output is twice the reference voltage. Voltage outputs feed back to the ADC MUX such that firmware can calibrate out DAC INL errors.

A single LTC1661 10 bit, serial, dual channel, DAC is used to provide the arc threshold and filament current limit input voltages to the new 7681 HVPS. The part was chosen for it low cost, ready availability at national distributors, and reasonable DNL specifications. Voltage outputs are not fed back to the ADC MUX as high accuracy is not required on these threshold inputs.

2.5.29 mA Low RangeTo support future scan modes, an mA low range circuit is provided. The FLEX PLD provides a control bit by which the firmware can switch the mA DAC reference voltage from 2.048V to 0.5V, hence decreasing the LSB size, hence allowing the firmware to take smaller voltage steps when ramping to low uA settings. A second control bit is provided to switch the ADC from 5.0 to 0.5V reference.

2.5.30 Detector InterfaceThe cSBC provides a RS-422 communications post to the Detector Mother Board. The CSBC does not participate in any Detector data manipulation, all analysis and Detector control is performed at the DMB.

This document contains confidential or proprietary information of GE-Lunar Corp. Neither the document nor the information therein is to be reproduced, distributed, used or disclosed, either in whole or in part, except as specifically authorized by GE-Lunar Corp.

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2.5.31 Communications PortsHost RS-422 Port

The host I/O port provides optical isolation per medical leakage requirements of EN 60601-1-1, Annex BBB, section 7. QT's 6N136 opto's are used to provide the required 115.2KB operational bandwidth and the required 2500 Vrms standoff at a reasonable price. Opto inputs and outputs are routed through the MAX PLD to support the hardware pass though mode to the DMB. A DB-9 female connector is provided on the host side of the isolation barrier. RS-232 is supported by populating the XCVR U26. RS-422 is supported by U21 and U37, the RS-422 XCVR's. A simple charge pump circuit is used to generate +5V_ISO on the host side of the barrier. Prodigy II will populate the RS-422 section and run at 115.2KB.

2.5.32 Debug RS-232 Port

The debug port is provided such that the firmware can echo status messages and other information to a dumb terminal to support debugging, development, testing, and servicing. The port is fully driven by a 16550 compatible UART is fully connected to a DB-9 header using the standard PC comm port pinout. The firmware can be configured to accept input from the debug port if required. The port is expected to be depopulated in the final production BOM to minimize cost.

2.5.33 Diagnostic LED's16 diagnostic LED's are provided by the cSBC. Functionality is listed below

LED

Color Function Description (status indicated when lit)

D13 Green +24V +24V DC input from supply present.

D14 Green +12V +12V DC input from supply present.

D15 Green -12V -12V DC input from supply present.

D7 Green +5V +5V DC input from supply present.

D16 Red FLEX CONFIG FLEX PLD not programmed.

D20 Red CPU RESET CPU in reset mode.

D19 Red SCANNER RESET Scanner in reset (failsafe) mode.

D27 Red AGS ROLL AGS roll over or under detected.

D29 Amber FLEX DIAG 1 Diagnostic LED for misc use by firmware, control reg in FLEX.

D31 Amber FLEX DIAG 2 Diagnostic LED for misc use by firmware, control reg in FLEX.

D22 Amber MAX DIAG 2 Diagnostic LED for misc use by firmware, control reg in MAX.

D28 Amber TRANS OMI Valid transverse motion sensed by OMI circuitry.

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D22 Amber LONG OMI Valid longitudinal motion sensed by OMI circuitry.

D25 Amber HE COUNT Valid high energy photon event sensed by DCA circuitry.

D23 Amber LE COUNT Valid low energy photon event sensed by DCA circuitry.

D21 Amber HVPS ENABLE 7681 HVPS enabled.

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2.6 Power Distribution (PRODIGY II Systems DF+1200 and greater)

The PRODIGY II system reduces scanner cost by using a single switching DC power supply which provides +5,+/-12, and +24VDC. The supply is connected directly to the cSBC via J14. J13 is provided as a power out connector to run power to the DMB for Prodigy II. 0R0 bypass resistor are provided to allow flexibility in grounding and filtering schemes. The PWB is divided into 4 ground plane regions - DGND for +5V digital returns, AGND for +/-12V analog returns, SCNGND for +24V returns, and ISO_GND for the host I/O island. Large zeners and rectifiers are provided for over-voltage and reverse-voltage protection. Standard capacitor filter banks are provided. For EMC all cable exits other than host and DMB I/O are located over the 24V planes. The 24V plane is separated from the 5V plane via optical isolation to prevent 5V noise from reaching cables (radiated EMC) and to prevent motor noise and ESD pulses from reaching the digital and analog IC's. The 24V plane contains primarily power FET switches and power resistors used to control scanner motors, X-ray source, LED, etc. The +/-12V planes contain analog electronics used for detector and HVPS control. A +12V regulator is used to produce 12VDC for the Centent drives of off +24VDC, maintaining isolation from the +12V plane. An additional +5V regulator is used to make 5V for the OMI's of off +12V motors. 4 opto channels are used to sense the presence of the 4 DC input voltages. The opto outputs are used to drive 4 green power on indicator LED's and to allow the CPU to detect power outs.

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2.7 Tube Head and X-ray InsertThe Tube Head consists of an oil-filled metal housing which contains a fixed-anode X-ray Insert (essentially a vacuum tube diode), lead-type shielding, collimating devices, a filament transformer, electrical connectors, and a Cerium (K-edge) filter.

THe X-ray generator provides a constant 76kV potential. mA control circuit regulates the fialment current via filament temperature to amintain the programmed current emission. The X-ray generator only provides mA monitor and mA limiting. PRODIGY I systems (DF+11999 and lower) have MAX CCA, PRODIGY II systems (DF+12000 and greater have mA control internal to the x-ray generator.

2.7.1 X-ray generation and Spectrum

• The X-ray Insert converts current into x-rays by accelerating the electrons across a large potential from the cathode into a tungsten target on the anode.

• The x-rays produced by the x-ray insert are filtered by the cerium filter to produce a dual energy spectrum. The x-ray spectrum has peaks at 62 and 38 kV.

• Insert potential is provided by a/the High Voltage Power Supply(ies).

• The tube current is set by the (c)SBC at 0.15 mA or 3.00 mA depending on the acquisition type.

• Tube Current is set by the (c)SBC and regulated by the MAX Board (PRODIGY I) or the Power Supply (PRODIGY II systems).

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2.8 X-ray Generator (High Voltage Power Supply(ies)) The PRODIGY X-ray production system combines a constant potential x-ray generator (consisting of either one or two high voltage power supplies) and an X-ray tube. The x-rya generator provides a continuous output of 38 kV each and up to 5 mA (PRODIGY I) or 3.5 mA (PRODIGY II) to the X-ray tube. The x-ray insert anode is composed of a tungsten alloy. The specifications of the X-ray generation subsystem is outlined in section 2.16.7.

• The High Voltage Power Supply(ies) provide the anode/cathode potential to the X-ray insert.

• PRODIGY I scanners use two high-voltage power supplies (±40kVDC). During normal operation, 76kVp is applied (+38kV at the anode and -38kV at the cathode).

• PRODIGY II scanners use a single high-voltage power supply (±40kVDC). During normal operation, 76kVp is applied (+38kV at the anode and -38kV at the cathode).

• The High Voltage Power Supplies are controlled by the (c)SBC.

• These power supplies are powered by the AC line voltage and have their own built in fusing.

• The AC power is routed thru the isolation transformer (PRODIGY I Only) and the supply(ies) are enabled via a relay (see section 2.1.1).

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2.9 MAX Board (PRODIGY I systems DF+11999 and lower only)

2.9.1 MAX Board Function

• The Tube Head and MAX Board work with the dedicated +28VDC power supply to supply tube head current.

• The current is set by the SBC (see section 2.4).

• MAX board actually regulates current to the filament transformer in the Tube Head.

2.9.2 Dedicated +28VDC power supply

• The +28 VDC dedicated power supply is switched on (for fail-safe purposes) by a solid-state relay.

• When errors are detected by the SBC, (for example, loss of arm motion) the relay will switch off and prevent production of x-rays.

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2.10 XORB Board (PRODIGY I Systems DF+11999 and lower only)

The XORB printed circuit board provides protection to various circuits (low voltage) from transients within the HVPS and tube head (see 2.1.1 for location).

• There may be occasional static discharges within the Tube Head. The transients caused by these static discharges (arcs) are shunted to ground through the array of transorbs present on the XORB board.

• There is no safety hazard to personnel, however, the electronics could be damaged were no protection provided.

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2.11 Detector Sub System2.11.1 Detector Overview

• 16 individual CZT (cadmium zinc telluride) crystals which convert X-ray energy directly to electrical charge

• The charge pulse generated by the individual detectors is directly proportional to the photon energy that generated the charge pulse (see 2.16.9 for spectrum information).

• The array of 16 CZT crystals each act as pixel detectors, from which the data is combined to form the densitometry data set.

• The Detector electronics amplify, discriminate and counts x-rays for all 16 detector elements.

• The detector communicates with the SBC.

• The Detector has 5 PCB associated with it, the Detector Mother Board (DMB) and 4 identical Detector Daughter Boards (DDB’s).

• The detector has its own dedicated High Voltage Power Supply, used for supplying detector bias.

2.11.2 Detector Operation

Figure 2-15. Detector Block Diagram

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The Detector is held at 450 VDC bias. When a X-ray strikes the detector an electron pair is created (small black arrows in the block diagram). This charge pair induces a small amount of current in the CZT crystal.

A charge sensitive pre-amp then converts the current to voltage and passes the signal along to the Detector Daughter Board for processing and analysis. The signal out of the pre-amp is a +5 to +10 millivolt DC signal, each event on each channel creates a small “blip”.

2.11.3 Detector Daughter Board Overview

• Each DDB processes the data from 4 of the 16 detector elements simultaneously.

• Each detector element is handled as a separate channel.

• Each DDB is responsible for:

• Pulse Shaping

• Gain Adjust

• Energy discrimination (high or low energy)

• Event counting

• Each DDB is electronically identical

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Figure 2-16. Detector Daughter Board Operation

2.11.4 Detector Daughter Board Operation

Gain Stage / Pulse Shaping

The Detector Daughter Board takes the +5 to 10 millivolt signal, strips off the DC offset and shapes the pulse into a bi-polar pulse. This signal is further amplified to 2.4 VDC and is then fed to a bank of 4 pairs of comparators.

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The four fine gain control comparators are set up in two windows around the High Energy signal. If the signal falls into the lower window a signal is sent to the programmable logic (PLD). The PLD then sends an amplify signal to a DAC which in turn increases gain slightly at the pulse shaping amplifier, so that the High Energy Signal is +2.4 VDC. If the High Energy signal falls into the upper window, the fine gain is adjusted down slightly by the same mechanism at the pulse shaping amplifier, again so that the High Energy Signal is + 2.4 VDC.

The fine gain adjust is applied to the entire signal on a particular channel at the pulse shaping amplifier, therefore the Low Energy Signal’s gain is adjusted along with the High Energy Signal.

The 4 comparators of the Gain Stage are set by digital to analog converters (DAC’s) which use reference values stored in the Flash RAM of the Detector Mother Board.

Energy Discrimination and Pulse Counting

The amplified and gain adjusted pulse is simultaneously fed to a second bank of 4 comparators which are divided again into two sets of windows. The windows of the Discrimination stage are centered around the High and Low Energy pulses. These comparators are also set by DAC’s which are set by the DMB Flash RAM.

Each time a pulse falls into the High Energy window, a counter in the programmable logic (PLD) is ticked, the same happens for the Low Energy window. These two data signals are then passed to the DMB, which transmits the data to the SBC.

2.11.5 Detector Mother Board Overview

• Contains 4 slots for the DDB’s (see figure 2-9)

• Contains a slot for the Test Point Board (part of the PRODIGY tool kit see figure 2-9)

• The Detector Mother Board provides +5 V, ±12 V plus digital and analog grounds to the Detector Daughter Boards.

• The Detector Mother Board communicates with the SBC via RS-422 link.

• The patient positioning laser is controlled by the SBC via the DMB (See figure 2-9).

2.11.6 Detector Mother Board Operation

The Detector Mother Board (DMB) contains a processor and Flash RAM, which supplies programming data to the detector subsystem. The data for all comparator settings is stored here (set values), detector Bias programming data, firmware to program the PLD’s of the 4 DDB’s, the Peak value calculation operation for the detector (see section 2.17 for a discussion of the Secondary Calibration (QA)).

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If the Flash RAM is corrupt, the DMB will read from the Firmware on the SBC. The Flash RAM can be reprogrammed from the Host / SBC.

The DMB has a processor, which is responsible for performing the Peak calculation during a Secondary Calibration (QA), programming the 4 DDB PLD’s and handles all communications with the SBC. The DMB processor sends the SBC status reports and echoes back all commands that are sent to it.

The DMB will reset the SBC if it detects an error.

Error Conditions of the DMB sensed by the SBC:

• PLD programming failure

• Loss of +5 or +12 VDC

• Loss of Communications with SBC

• Corrupt FIRMWARE

• FLASH RAM Failure

• DTR Reset button on the DMB is pressed

Figure 2-17. PRODIGY Detector Module

1 = Test Point Board, 2 = Detector Daughter Boards (4), 3 = Patient Positioning laser and Detector Mother Board Interface, The Detector Mother Board is the horizontal circuit board

that the DMB’s and Test Point Board are plugged into.

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2.12 FOINK (PRODIGY I Systems DF+11999 and lower only)

2.12.1 FOINK Functions

• The FOINK Board optically isolates control circuitry (SBC) from the rest of the scanners electronics (see pan layout Appendix 2B).

• Shutter solenoid

• Scanner Motor Controllers

• Display Panel indicators and controls

• Monitors 5 different interrupts, all of which are capable of resetting the SBC (shutting down x-ray production)

• Emergency Stop Switch - open circuit - (loss of signal - failsafe)

• Tube Head Thermocouple - circuit open (loss of signal - failsafe)

• Longitudinal Motion Interrupt - source open no movement (OMI)

• Transverse Motion Interrupt - source open no movement (OMI)

• Failure of the +28 VDC Power Supply

2.12.2 Motion Control and Detection

• Motor pulses, RUN/HOLD signals and direction are generated by the SBC.

• The RUN/HOLD signals are optically isolated on the FOINK board before being sent to the Centent motor drivers. The Centents supply current to the stepper motor windings.

• Both the transverse and longitudinal drive systems have slotted disks attached which pass through optical interrupters (OMI) for motion detection. Should motion stop during patient scanning, the FOINK sends an interrupt to the SBC, which is reset and x-ray production is halted.

• Limit switches at each end of the scanner and each end of the arm signal the SBC whenever motion reaches either end or side of the scanner. If a limit switch is tripped during a patient scan, the motor associated with the tripped limit switch is halted, the SBC is reset and the shutter is closed.

• There is a dedicated DC power supply for the motion control circuitry, supplying +26VDC. The +26VDC ground is isolated from the logic ground to reduce noise (see section 2.1.1 for location)

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2.13 Display Panel• The Display Panel of the PRODIGY, located on the front face of the

upper arm, is the main operator interface outside the host computer.

Figure 2-18. PRODIGY display panel

• Four indicators display system status.

• A green Light Emitting Diode (LED) indicates a power-on condition; it lights when the +26VDC power supply comes on.

Power on LED is lit whenever scan table power is on.

• A yellow LED indicates if the laser is on

The laser on LED is lit when the SBC signals the DMB to turn the laser on, the LED is switched on by the DMB.

• An amber X-ray On LED indicates that x-rays are being produced (current is flowing through the X-ray Insert), though exposure is not necessarily taking place.

The X-ray on LED is lit when more than X current is flowing through the X-ray insert.

• The yellow Shutter Open LED comes on is the Shutter open and exposure possible.

The Shutter open LED is controlled by the SBC, the SBC will allow the shutter to open even if the lamp is not lit (shutter open indicator is also on the PC controller screen).

Note: It is not recommended that scanner operation be continued if These LED's signal the operator of exposure to x-rays and must be replaced as soon as possible.

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• Rocker switches on the panel allow operator control of the beam position.

The Rocker switches are enabled by the SBC via the FOINK.

Note: The rocker switches are also referred to as the joystick in the PRODIGY Service Manual and the PRODIGY Service Software.

• The Emergency stop button (red), is to be used only in emergency situations; it resets the (c)SBC and halts x-ray production.

The FOINK or cSBC detects if this normally closed circuit is opened (fail-safe operation).

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2.14 Audible X-RAY OFF Signal• An audible signal notifies the operator that there is a “safe” condition

when the Shutter is closed.

• The FOINK or cSBC board senses the closure of the Shutter or the cessation of current through the X-ray Insert (+28VDC Power Supply or Model 7861 HVPS) and switches on the audible signal if either of these occur during an exposure.

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2.15 X-Ray Collimator Subsystem• The Shutter is actuated by a rotary solenoid using +26 VDC, the voltage

is reduced to a holding voltage of 12VDC after the shutter is opened.

• This solenoid is controlled by signals generated on the SBC, and optically isolated through the FOINK board on PRODIGY I systems.

• An optical interrupter (OMI) detects the shutter open condition and reports shutter position information back to the (c)SBC.

• This assembly is located on top of the X-ray Tube Head.

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2.16 PRODIGY Specifications2.16.1 Component specifications

Table 2-3 gives specifications for standard components shipped with the PRODIGY system.

Table 2-3. PRODIGY Component Specifications

*Depth is measured from the front edge of the scanner table to the back edge of the scanner arm. Height is measured from the top of the scanner arm to the bottom of the scanner arm.

*Width is measured from the front edge of the scanner table to the back edge of the scanner arm. Height is measured from the top of the scanner arm to the bottom of the scanner arm.

#Some languages may require 1024x768x16-bit color to fit the translated software text on the screen

@GE-LUNAR Recommends Diskeeper Lite (Executive Software - http://www.execsoft.com - Glendale, California, USA)

2.16.2 Functional specifications

General specifications

Focal spot to image receptor distance is 67 cm. Attenuation equivalence of patient support table is 0.7 mm Al.

2.16.3 Maximum scan area (long x transverse)

Component Specifications

Scanner table*Dimensions: 262.3 cm x 109.3 cm x 128.3 cm

Weight: approximately 272.16 kgMaximum patient weight supported: 136 kg

Console table 78.5 cm x 63.3 cm x 48.1 cm

Computer

Greater than 266Mhz Pentium128 MB RAM

Greater than 1GB hard disk17” SVGA monitor (800x600x16-bit color)

LS-120 Super driveCD ROMModem

Windows® NT version 4.0 operating system with service pack 6

Internet Explorer version 4.01 with service pack 2Fast Serial I/O board (LUNAR part number 7151)

Printer HP DeskJet 930CW x D x H—44.0 x 40.0 x 19.6 cm

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• AP Spine Measurements40.3 cm x 18 cm

• Femur Measurements20.2 cm x 18 cm

• Dual Femur Measurements20.2 cm x 18 cm (each femur - two scan areas)

• Total Body Measurements197.5 cm x 60 cm measurement field

2.16.4 Programs

Note: Depending on the number of options purchased, not all of the options listed below may be included with the PRODIGY system software:

• AP spine measurement and analysis

• Femur measurement and analysis

• Total Body measurement and analysis.

• Forearm measurement and analysis

• Lateral spine measurement and analysis

• Quality Assurance

2.16.5 Environmental specifications

Operational environment

Adhere to the specifications that follow during scanner operation:

• •Ambient Space (Interior Subcomponents)–For scanner operation and servicing, do not block the area around the scanner table. Make sure there is a minimum clearance of 30.5 cm at the head and foot ends of the scanner table, at least 15.2 cm for the arm side, and 45.7 cm for the operator side.

• Ambient Space (Ventilation)–Do not block the cooling vents on the computer and scanner table. Make sure there is 15.2 cm from the console table to the wall for cable clearance and computer plugs.

• Dust, Fumes and Debris–Install the system in a clean, ventilated area. Dust and other airborne debris can cause the diskette drive heads and other sensitive mechanical components to malfunction. GE-LUNAR recommends that smoking is not permitted in the scanner room.

This document contains confidential or proprietary information of GE-Lunar Corp. Neither the document nor the information therein is to be reproduced, distributed, used or disclosed, either in whole or in part, except as specifically authorized by GE-Lunar Corp.

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• Humidity–Make sure the humidity for the scanner area is 20%–80%, non-condensing.

• Static Electricity–Install and operate the system in a static-free area. Adhere to minimum humidity requirements to prevent malfunctions caused by static electricity.

• Shock and Vibration–Make sure the scanner table does not receive shock greater than 1 G for more than 1 millisecond. Make sure the scanner table does not receive vibrations greater than 0.25 G at 5 Hz.

• Temperature–Make sure the temperature during system operation is 65°F–81°F (18°C–27°C).

Note: When the system is turned off, or there is a power failure, allow the system to be on and let it warm for one hour. After one hour, complete a Quality Assurance procedure.

2.16.6 Storage and transport environment

Adhere to the specifications that follow for scanner storage and transportation:

• Humidity, 0% to 95% non-condensing.

• Atmospheric pressure, 500 to 1060 hPa.

• Temperature, -40° to 70° C.

2.16.7 X-ray generator (system no. DF+12000 and higher)

Table 2-4. X-ray generator technical information.

Classification Class I Equipment IEC 601-2-7 5.1

Degree of protection against electrical shock Type B equipment IEC 601-2-7 5.2

Protection against ingress of liquids Ordinary medical electrical equip-ment IEC 601-2-7 5.3

Connection to supply mains Power supply cord IEC 601-2-7 6.1g)

Mode of operation Continuous IEC 601-2-7 6.1m)

Maximum X-ray tube voltage 76 kV IEC 601-2-7 6.1m)

Maximum X-ray tube current 3 mA IEC 601-2-7 6.1m)

Rated mains voltage 100-240 VAC IEC 601-2-7 6.1j)1

Number of phases in mains 1 IEC 601-2-7 6.1j)2

Mains frequency 50/60 Hertz IEC 601-2-7 6.1j)3

This document contains confidential or proprietary information of GE-Lunar Corp. Neither the document nor the information therein is to be reproduced, distributed, used or disclosed, either in whole or in part, except as specifically authorized by GE-Lunar Corp.

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Required over-current releases 15 Amp dedicated service IEC 601-2-7 6.1j)5

Heat dissipative components

X-ray tube dissipates 243W max. into surrounding air through forced air convection. Flow rate: 36 m3/h (approx.) Temp. rise of air stream

25° C (approx.)

IEC 601-2-7 6.1t)

Allowable high voltage supplies Spellman SBD40PN280X2890 orBertan 2907.

IEC 601-2-7 6.8.1and 50.2.101-102

Allowable tube head assemblies LUNAR model 8743 or equivalent IEC 601-2-7 6.8.1and 50.2.101-102

Original language of accompanying docu-ments English IEC 601-2-7 6.8.1

Maximum continuous kV, mA at nominal rated kV 76 kV, 3 mA IEC 601-2-7 6.8.2

1)

Maximum intermittent kV, mA at nominal rated kV 76 kV, 3 mA IEC 601-2-7 6.8.2

1)

Maximum continuous kV, mA at maximum mA 76 kV, 3 mA IEC 601-2-7 6.8.2

2)

Maximum intermittent kV, mA at maximum mA 76 kV, 3 mA IEC 601-2-7 6.8.2

2)

Continuous kV, mA for maximum electric output power 76 kV, 3 mA IEC 601-2-7 6.8.2

3)

Intermittent kV, mA for maximum electric output power 76 kV, 3 mA IEC 601-2-7 6.8.2

3)

Nominal electric power 0.243 kW IEC 601-2-7 6.8.24)

Lowest current time product0.20 mAs. Parameters: 76 kV, 0.10

mA, 2 seconds.

IEC 601-2-7 6.8.25)

Nominal shortest irradiation times 2 seconds. IEC 601-2-7 6.8.26)

Method of x-ray tube voltage measure-ment

Voltage divider in high voltage power supply.

IEC 601-2-7 50.106.1

Method of x-ray tube current measure-ment

Shunt resistor in high voltage supply return line.

IEC 601-2-7 50.106.2

X-ray tube assembly reference axisLine normal to the tube port, cen-

tered on tube port as shown in Figure 4.

IEC 601-2-7 6.1j)5) 50.107.1

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2.16.8 X-ray generator (system no. DF+11999 and lower)

Table 2-5. Table 4. X-ray generator technical information.

Reference loading conditions 8.21 x 105 Joules, 3 mA, 76 kV for 1 hour.

IEC 601-1-3 29.204.2

Focal spot to Image Receptor distance 67 cm IEC 601-1-3 29.203.2

Attenuation equivalence of patient support table. 0.7 mm Al IEC 601-1-3

29.206.2

Classification Class I Equipment IEC 601-2-7 5.1

Degree of protection against electrical shock Type B equipment IEC 601-2-7 5.2

Protection against ingress of liquids Ordinary medical electrical equip-ment IEC 601-2-7 5.3

Connection to supply mains Power supply cord IEC 601-2-7 6.1g)

Mode of operation Continuous IEC 601-2-7 6.1m)

Maximum X-ray tube voltage 76 kV IEC 601-2-7 6.1m)

Maximum X-ray tube current 5 mA IEC 601-2-7 6.1m)

Rated mains voltage 100, 110, 115, 120, 125, 127, 200, 220, 230, 240, 250, and 254 volts IEC 601-2-7 6.1j)1

Number of phases in mains 1 IEC 601-2-7 6.1j)2

Mains frequency 50/60 Hertz IEC 601-2-7 6.1j)3

Required over-current releases 20 Amp dedicated service IEC 601-2-7 6.1j)5

Heat dissipative components

X-ray tube dissipates 305W max. into surrounding air through forced air convection. Flow rate: 36 m3/h (approx.) Temp. rise of air stream

25° C (approx.)

IEC 601-2-7 6.1t)

Allowable high voltage supplies

Spellman X2112/X2113/ rev. K and higher. Bertan 2411P and 2411N

rev. A and higher. LUNAR p/n 0311 and 0312.

IEC 601-2-7 6.8.1and 50.2.101-102

Allowable tube head assemblies LUNAR model 6838 or equivalent IEC 601-2-7 6.8.1and 50.2.101-102

Original language of accompanying docu-ments English IEC 601-2-7 6.8.1

This document contains confidential or proprietary information of GE-Lunar Corp. Neither the document nor the information therein is to be reproduced, distributed, used or disclosed, either in whole or in part, except as specifically authorized by GE-Lunar Corp.

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Maximum continuous kV, mA at nominal rated kV 76 kV, 4 mA IEC 601-2-7 6.8.2

1)

Maximum intermittent kV, mA at maximum kV 76 kV, 5 mA IEC 601-2-7 6.8.2

1)

Maximum continuous kV, mA at maximum mA 61 kV, 5 mA IEC 601-2-7 6.8.2

2)

Maximum intermittent kV, mA at maximum mA 76 kV, 5 mA IEC 601-2-7 6.8.2

2)

Continuous kV, mA for maximum electric output power 76 kV, 4 mA IEC 601-2-7 6.8.2

3)

Intermittent kV, mA for maximum electric output power 76 kV, 5 mA IEC 601-2-7 6.8.2

3)

Nominal electric power 0.4 kW IEC 601-2-7 6.8.24)

Reference current time product7.89 mAs. Parameters: 76 kV, 2.63

mA, 3 seconds.

IEC 601-2-7 6.8.25)

Nominal shortest irradiation times 3 seconds. IEC 601-2-7 6.8.28)

Repetition rate for loading during tests

No specific wait period was imposed.

Time between tests was approxi-mately

20 seconds.

IEC 601-2-7 50.104.4

Method of x-ray tube voltage measure-ment

Voltage divider in high voltage power supply.

IEC 601-2-7 50.106.1

Method of x-ray tube current measure-ment

Shunt resistor in high voltage supply return line.

IEC 601-2-7 50.106.2

X-ray tube assembly reference axisLine normal to the tube port, cen-

tered on tube port as shown in Figure 4.

IEC 601-2-7 6.1j)5) 50.107.1

Reference loading conditions 1.09 x 106 Joules, 4 mA, 76 kV for 1 hour. IEC 601-1-3

Leakage radiation was measured at the following loading factors. 3mA, 76 kV IEC 601-1-3

Focal spot to Image Receptor distance 67 cm IEC 601-1-3

Attenuation equivalence of patient support table. 0.7 mm Al IEC 601-1-3

This document contains confidential or proprietary information of GE-Lunar Corp. Neither the document nor the information therein is to be reproduced, distributed, used or disclosed, either in whole or in part, except as specifically authorized by GE-Lunar Corp.

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Figure 2-19. Reference axis and target angles for tube head assembly

2.16.9 GE-LUNAR 8022 x-ray tube

Table 2-6. LUNAR 8022 X-ray tube technical information.

Nominal anode input power 361 Watts IEC 613/1989

Maximum anode heat content 6000 Joules IEC 613/1989

Anode heating and cooling curves Refer to figure 5. IEC 613/1989

Anode target material Tungsten IEC 601-2-28

Reference axis Refer to figure 4. IEC 601-2-28

Target angle 78° (reference to nor-mal) IEC 601-2-28

Nominal focal spot values 0.5 IEC 336/1982

Maximum useful voltage 95 kVp Not Applica-ble

Maximum filament current 2.2 Amperes Not Applica-ble

This document contains confidential or proprietary information of GE-Lunar Corp. Neither the document nor the information therein is to be reproduced, distributed, used or disclosed, either in whole or in part, except as specifically authorized by GE-Lunar Corp.

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Figure 2-20. Anode heating/cooling curves

2.16.10 GE-LUNAR 8743 x-ray tube head assembly (system no. DF+12000 and higher)

• Beam filtration is permanently fixed with a minimum 2.9 mm Aluminum-equivalent.

Table 2-7. LUNAR 8743 x-ray tube assembly technical information.

Inherent filtration >2.9 mm Al/70 kV IEC 522/1976

Filament characteristics Refer to Figure 6. IEC 613/1989

Nominal x-ray tube voltage76 kV - Anode to Cathode

38 kV - Anode to Earth38 kV - Cathode to Earth

IEC 613/1989

Single load rating 228 W (3 mA, 76 kV) for up to 15 min. IEC 613/1989

Serial load rating

228 W (3 mA, 76 kV) for up to 15 min. with a

5 min. cool down time between mea-surements.

IEC 613/1989

Maximum x-ray tube assembly heat con-tent 260 Kjoules IEC 613/

1989

X-ray tube assembly heating and cooling curves Refer to Figure 7. IEC 613/

1989

This document contains confidential or proprietary information of GE-Lunar Corp. Neither the document nor the information therein is to be reproduced, distributed, used or disclosed, either in whole or in part, except as specifically authorized by GE-Lunar Corp.

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2.16.11 LUNAR 6838 x-ray tube head assembly (system no. DF+11999 and lower)

• Beam filtration is permanently fixed with a minimum 2.9 mm Aluminum-equivalent.

Note: Beam quality has a minimum first half-value layer of 3.2 mm of Al at 76 kV.

Table 2-8. LUNAR 6838 x-ray tube assembly technical information.

Maximum continuous heat dissipation 243 Watts (3mA x 76kV + 15W fila-ment)

IEC 613/1989

Maximum symmetrical radiation field 3.5 mm/19.4 mm at a distance from the focal spot of 220 mm.

IEC 806/1984

Dimensions 17 cm x 19.4 cm x 11 cm IEC 601-2-28

Weight 8.6 kg IEC 601-2-28

Inherent filtration >2.9 mm Al/70 kV IEC 522/1976

Filament characteristics Refer to Figure 6. IEC 613/1989

Nominal x-ray tube voltage76 kV - Anode to Cathode

38 kV - Anode to Earth38 kV - Cathode to Earth

IEC 613/1989

Single load rating361 W (4.75 mA, 76 kV) for up to 4

min., 59 sec.

IEC 613/1989

Serial load rating

361 W (4.75 mA, 76 kV) for up to 4 min.,

59 sec. with a 10 min. cool down time between measurements.

IEC 613/1989

Maximum x-ray tube assembly heat con-tent 260 kJoules IEC 613/1989

X-ray tube assembly heating and cooling curves Refer to Figure 7. IEC 613/1989

Maximum continuous heat dissipation 361 Watts IEC 613/1989

Maximum symmetrical radiation field 3.5 mm/19.4 mm at a distance from the focal spot of 220 mm. IEC 806/1984

Dimensions 17 cm x 19.4 cm x 11 cm IEC 601-2-28

Weight 8.6 kg IEC 601-2-28

This document contains confidential or proprietary information of GE-Lunar Corp. Neither the document nor the information therein is to be reproduced, distributed, used or disclosed, either in whole or in part, except as specifically authorized by GE-Lunar Corp.

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Figure 2-21. Cathode emission characteristics

Figure 2-22. X-ray tube assembly heating/cooling curves

2.16.12 Laser specifications

Table 3-9 gives the specifications for the GE-LUNAR laser.

Table 2-9. Laser specifications.

Output Power <1mWWavelength 635nm

Beam Diameter at aperture 4x1mm

Aspect Ratio 4.0 to 1Divergence 24 degrees

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2.16.13 Compatible components

For customers located internationally, make sure the computer is certified to local requirements. The computer must meet the minimum requirements that follow:

• Greater than 266MHz Pentium

• 128 MB RAM

• Greater than 1GB Hard Disk

• 8X CD ROM

• 14” SVGA monitor with at least 800x600x16-bit color

• Windows NT version 4.0 operating system with service pack

• Internet Explorer version 4.01 with service pack 2

2.16.14 FDA Certified Components (USA Only)

Tables 2-9 and 2-10 list components certified to the FDA for use with PRODIGY scanners and is updated periodically. Contact GE-LUNAR for a current listing of compatible components.

Table 2-10. FDA certified components (system no. DF+12000 and higher).

Radiant Exposure 0.0001 WIntegrated Radiance 46 W

Current Draw 105 mAVoltage Input 4-6 VDCSafety Rating Class II

Component Description LUNAR Model #

X-ray Controller LUNAR single board controller 7635

High Voltage Power Supplies

Bertan1 Model: 2907Spellman2 Model:

SBD40PN280X2890

76817681

Tube Head Assembly LUNAR X-Ray Tube Head Assembly 8743

Collimator LUNAR PRODIGY Collimator Assem-bly 8915

1Bertan High Voltage Corp., 121 New South Road, Hicksville, NY2Spellman High Voltage Electronics Corp., 475 Wireless Boulevard, Hauppauge, NY

Table 2-9. Laser specifications. (continued)

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Table 2-11. FDA certified components (system no. DF+11999 and lower).

Component Description LUNAR Model #

X-ray Controller LUNAR PRODIGY single board con-troller 5447

High Voltage Power Supplies

Spellman1 Models:PTV40N200X2113PTV40P200X2112

03110312

Bertan2 Models:2411 N2411 P

03110312

Tube Head Assembly LUNAR X-Ray Tube Head Assembly 6838

Collimator LUNAR PRODIGY Collimator Assem-bly 6893

1Spellman High Voltage Electronics Corporation Hauppauge, NY2Bertan Associates, 121 New South Road, Hicksville, NY

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2.17 Secondary Calibration / Daily QA2.17.1 Secondary Calibration overview

• Daily QA (Quality Assurance) tests the integrity of the scanner so operator knows it is operating within specifications.

• Daily QA (Secondary Calibration) adjusts the calibration of the scanner to offset any changes due to the tube aging, temperature varying, or when certain components are changed.

• A third type of function, QC Phantom, is another method for testing system performance. A QC phantom is scanned using standard software and results are stored (aluminum spine in lucite).

• Daily QA ensures the system is operating properly by running 3 types of tests:

• A peak test to adjust photon counting electronics.

• A functional test that checks the indicator lights, motion system, shutter, tube output, and detector performance.

• A test that measures a secondary calibration object with different bone chambers and tissue plugs which correct for system aging and prevents long-term drifts.

• On many tests, the results must be calculated for all 16 detectors separately. The display for the test will consist of the mean value.

• All tests are run all of the time. The tests are executed and test results reported as each test completes. Test results include pass/fail and any quantitative information when appropriate.

2.17.2 Starting the Daily QA (secondary calibration)

Operator presses [F5] to start [Daily QA] which presents a plot of the last used parameter from the last Daily QA run. (Default display is the medium bone chamber.) At this point operator can interactively manipulate the data in QA database to create tables and graphs that can be printed.

Tech presses [Start] to start running Daily QA tests.

Software displays instructions to position calibration block on the table. Tech places block on tabletop silk screen and click [OK] to start.

The UI locks out all other operations except Stop button.

Scan arm moves to the "Home" position. In this case, Home is always at head of scanner for QA independent of user setting for Home.

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2.17.3 Tests Performed in the Secondary Calibration

Detector Mother Board Self Test

The DACs and Flash RAM of the Detector Mother Board are tested.

Find Block

The scanner performs a scout scan to find the block. If block is not properly positioned, the scanner will prompt the user to Reposition standard more accurately.

The software automatically finds landmarks within the secondary phantom. This reduces the need for exact positioning on the table top.

Peak Test

During this test, the shutter opens with the x-rays on.

This test adjusts the sensitivity of the photon counting electronics. The test determines the optimal voltage setting for the detector amplifier so the maximum number of photons are detected. With the shutter open the software adjusts the voltage setting for the detector amplifier, acquiring counts at the different amplifier settings.

The detector peak test then determines the optimal voltage setting for the detector amplifiers based on the results. The actual peak setting is taken from the high energy count rates, the low energy channel is essentially blocked by the brass spillover piece in the QA standard.

Beam Stop test

Measures the movement of the source shutter. A functional test checks the shutter LSW and ensures the shutter stops all photons.

Motor motion and limit switches

OMI Interrupt function - the OMI signal is tested by verifying the OMI Interpol signal is present when the scan arm is stationary.

Each motor (transverse, longitudinal) will be run between hard limits and back to home position. If the hard limits do not engage, this is a failure. Also compare steps against predetermined scan window size.

If a failure occurs the number of steps taken, the expected value and the direction the arm was traveling is noted in the error log.

Spillover test

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Measures the effect of high energy photons registering as low energy photons in the detector system. The beam passes through a brass piece that stops all low energy photons. The detector then measures the number of low energy photons detected as a measure of spillover. Spillover should be less than 13%. Spillover with the CZT detector will degrade about 0.2% per year.

Spillover Stability test

As part of the secondary calibration, the change in spillover must be calculated on a per element basis and smoothed over the last 3 passing QA's. Daily QA measures actual spillover and stores it in QA database. As part of primary calibration, the spillover value used during that calibration is stored. The delta spillover calculation using the spillover from primary calibration and the running average of the last five spillover measurements. This information is in the scan file.

Reference Value Test

The output of the x-ray tube is measured as part of a Reference Value (old term was air) measurement. This is measured at various currents between 3mA and 0.150mA.

Note: Not all currents that are ramped to / tested are used to perform patient scans.

Reference Value measurement

The HE/LE counts are measured as the number of photons counted by detector. This value is used in all bone density calculations. It must be stored in the systems data file. Limits for low/high counts -

• Reference value measurements will be performed at various currents. These reference values are stored separately for all detector elements.

• Reference Value measurements for all current settings are actually made through lucite sections of the secondary calibration block.

Reference value ratio test

The HE/LE ratio for each reference value is calculated for each tube current tested in reference value measurement.

Detector Pre-AMP test

The detector Pre-amplifiers are tested by removing detector bias and verifying that the signal out lines of the detector are not noisy.

Tissue Value Test

Tissue secondary calibration

• The system measures two tissue eqivilent materials (lucite and Acetron).

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• Store measured values for each chamber per element in QA database.

• The system determines the%fat for two different materials with different compositions.

• Three%fat values are displayed - lean, mid and fat

• These calculated%fat values are compared against expected values and checked against limits for the mean, standard deviation.

BM Chamber Measurements

The system acquires point measurements on the 3 bone chambers (approx 12 seconds / measurement) using the 3ma medium scan mode. The system determines the bone mineral content for the three chambers of different sizes and densities.

• Measured values for each chamber are stored on a per element basis in the QA database.

• These calculated BM values are compared against expected values and checked against limits for the mean, standard deviation.

• A slope is calculated and this adjustment is used as a secondary BMD calibration to offset long term drifts in system performance.

Daily QA Results

At the end of Daily QA, a report is automatically printed. If printer is not on line or fails, post an error to screen.

If Daily QA fails, post an error message that says "Unsuccessful QA - Recommend repeating procedure."

• If a QA fails the error log will contain detailed information on the failure.

Test results are saved automatically to a database.

Appropriate secondary calibration and Reference Value information is recalculated from QA database using an average of the 3 previous passing test results. This information is stored in each scan file.

A view with plot of medium bone chamber is generated, and user the user is allowed to manipulate data interactively.

2.17.4 QA Database

A historical record of system performance is maintained by storing key QA parameters in a database.

• 3mA Results - fat is hidden - only bone results are viewable

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Figure 2-23. PRODIGY Daily QA printout with expected values

Lunar Corporation 726 Heartland Trail

Madison, WI 53717

1.051 Daily QA Measurement Date 3/20/00 Time 9:07:32 AM 1.007 BMD Medium (High mA) 0.971g/cm 0.971g/cm Deviation -0.82% Trend Summary 0.957 Mean BMD Medium (High 0.971g/cm CV Total Sessions 3 0.907 1/17/00 2/8/00 3/1/00 3/23/00 _____________________________________________________________________________ Functional Tests Secondary Calibration Test Value Status Test Mean %CV Status Block Position Pass BMD

Peaking 1400-3300 Pass Large Batch1 or 2 <=1% Pass

Beam Stop <=15 Pass Medium <=2% Pass

Mechanical Test Small <=3% Pass

Transverse 620mm min Pass Tissue

Longitudinal 1980mm min Pass Lean <=50% Pass

Mean % Spillover 5% to 13% Pass Mid <=20% Pass

Spillover Stability -1% to 1% Pass Fat <=10% Pass

Reference Counts Calibration Status Pass

High mA 15% from Primary Cal System Status Ratio at High mA Ratio Pass Pass

Detector Status Pass

*The BMD & Tissue values are Batch dependent and can be found in service options *Transverse - Total counts/20 with the result in millimeters *Longitudinal - Total counts/10 with the result in millimeters *Spillover Stability is spillover with respect to time.

Prodigy LUNAR (2.10)

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3 111Service Software

Chapter 1:Service Software This chapter contains a discussion of the Service Software and the Error Log.

3.0 Diagnostic Software . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1033.0.1 To Access the Service Software:. . . . . . . . . . . . . . . . . . . 1-103

3.1 The Tools Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1043.1.1 Spectrum. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1043.1.2 Stability Run . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1043.1.3 Signal Monitor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1043.1.4 Primary Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1043.1.5 Secondary Verification. . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1043.1.6 Pileup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1043.1.7 Set Download Parameters . . . . . . . . . . . . . . . . . . . . . . . 1-1043.1.8 enCORE Composer . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1053.1.9 Error Log . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1053.1.10 Copy Configuration . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1053.1.11 User Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1053.1.12 Service Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1053.1.13 Outbox. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1053.1.14 System File Editor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-105

3.2 Tools / Diagnostics Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1053.2.1 Pileup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1053.2.2 Calibration Pileup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1053.2.3 Spillover. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1053.2.4 Count Rate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1053.2.5 Scanner Motion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1053.2.6 Scanner Detector . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1063.2.7 Scanner X-ray . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1073.2.8 Lin/Rep . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1083.2.9 Limit Switch Adjustment . . . . . . . . . . . . . . . . . . . . . . . . . 1-1083.2.10 Scanner Disconnect . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-108

3.3 Diagnostic Scan Modes - . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1083.3.1 Table Top Scan - . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1083.3.2 Alignment Scan . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1083.3.3 Beam Wobble scan . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1083.3.4 Hacksaw . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-108

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3.4 Error Log . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1083.4.1 Printing the Error Log. . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1093.4.2 Troubleshooting Help software . . . . . . . . . . . . . . . . . . . . 1-1103.4.3 Reading the Error Log . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-112

3.5 Service Options. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1143.5.1 Measure Tab . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1143.5.2 Analyze Tab . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1143.5.3 QA Tab. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1143.5.4 Serial Tab. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-114

Figure 3-1. The Tools/Diagnostics Menu . . . . . . . . . . . . . . . . . . . . . . . 1-104Figure 3-2. The Error Log Dialogue Box . . . . . . . . . . . . . . . . . . . . . . . . 1-109Figure 3-3. Error log entry details . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-110Figure 3-4. enCORE Troubleshooting help screen capture. . . . . . . . . . 1-111Figure 3-5. Sample PRODIGY Error Log . . . . . . . . . . . . . . . . . . . . . . . 1-112

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3.0 Diagnostic SoftwareNote: GE-LUNAR Diagnostic software options are not available to

the customer. This software is available to GE-LUNAR authorized representatives only.

When the software is used in the diagnostic / service mode, the Engineer performing service must verify that the scanner is taken out of service mode before returning control of the scanner to

the customer. The software will return to operators mode as soon as the software is exited and restarted. The operator mode may also be changed under the Tools/User Options menu.

The Service software gives the Technician access to all areas of the PRODIGYSoftware, DO NOT adjust AGS subsystem settings.

• The Diagnostic Software is available through the User Options Tab

3.0.1 To Access the Service Software:• Start the PRODIGYSoftware by double clicking the PRODIGY Icon on

the desk top

• Double click the Tools option on the menu bar

• When the drop down menu appears double click on User Options

• Double click on the Systems Tab on the dialogue box

• Click on Service under Display Mode

• When prompted enter the password Award (versions 2.05 and greater) Smile versions lower than 2.05)

Note: the password is case sensitive

• The Tools option on the menu bar will now contain Service Options, and Service scanning options will also be available under the F2 Measure Option

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Figure 3-1. The Tools/Diagnostics Menu

3.1 The Tools Menu3.1.1 Spectrum

Allows the service engineer to view and print the raw energy spectrum for the detector. The detector can also be repeaked from Spectrum.

3.1.2 Stability RunUsed for the detection of arcing and testing the detectors performance

3.1.3 Signal Monitor View count rates for low and high-energy channels for the detector.

3.1.4 Primary CalibrationUsed to calibrate the PRODIGY scanner See DXAP@002 PRODIGY Primary Calibration Procedure Chapter 5 Appendix C.

3.1.5 Secondary VerificationUsed in the manufacturing process

3.1.6 Pileup Used in the manufacturing process

3.1.7 Set Download Parameters

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Download and verify the Firmware versions for the (c)SBC.

3.1.8 enCORE Composer This is not a service tool - (Physical and Business Report Generator - see the enCORE Operator’s Manual for information).

3.1.9 Error Log Ability to view and print the contents of the diagnostic error log (see section 3.4)

3.1.10 Copy ConfigurationAbility to copy the scanners Error log, Configuration Files and / or QA Database to a drive on the host PC - useful when a host PC is replaced or when diagnostic information needs to be sent to GE-LUNAR.

3.1.11 User OptionsSet up user configured options for the scanner.

3.1.12 Service OptionsService Mode scanner configurations (see section 3.5).

3.1.13 Outbox Configure Printing, E-mail and Faxing options.

3.1.14 System File EditorEdit system settings for the enCORE software - do not alter these settings without GE-LUNAR Customer Support authorization.

3.2 Tools / Diagnostics Menu3.2.1 Pileup

Determines Detector parameters for multiple events occurring simultaneously - not used for service.

3.2.2 Calibration Pileup Not used for service.

3.2.3 Spillover Perform and Acquire a Spillover Measurement (test of source spectrum and/or detector resolution).

3.2.4 Count RateAcquire and print Reference Counts (count rate of detector must be performed through lucite).

3.2.5 Scanner Motion

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Control manually and perform scanner motion diagnostics and motion configuration.

•Motion Tests Tab

•Limit Switch Monitor - used to verify limit switch status

•Limit to Limit Test - used to verify limit switch positions

• Configure check box- this box must be checked when limit to limit is run to establish the scanners range of motion (scan window).

•Cable Stress Test - used to cycle Transverse and Longitudinal Mechanics - can be used to check new cables / check for binding

•Home scanner - moves mechanics to Home position

•Motion Commands Tab

•Home Position - change Arm Parking position from head to foot - does not effect where the daily QA (Secondary calibration) is performed - Move to Home - sends scan arm to home position.

Note: When the Home position is changed from the head end of the table to the foot or vice versa, the Limit to Limit test (see Motion Tests tab above) must be run with the Configure box selected.

•Move Steps - move the scan arm to a specific location on the table - move Absolute moves an absolute distance from home, Move Relative - move relative to last position

•Joystick and Laser - Enable and Control Scanner Motion manually, change motor speeds, toggle laser on and off

•Lower portion of the screen displays the status of limit switches, scan arm position, and positioning switch (joystick) status.

•Find Block Tab

•Secondary Calibration - can be used to find / verify that the scanner is able to find the different chambers on the secondary calibration (daily QA) block. THis tool can be useful for troubleshooting “cannot find Block errors” and for Transverse binding issues.

3.2.6 Scanner Detector•Detector Tests Tab

•Gain Control - adjusts the gain on the AGS amplifier used in the detector peak setting - peak adjusts only the AGS amplifier.

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•Bias Control - adjusts the bias of the detector. PRODIGY Systems run with detector bias on demand (when x-rays are present) of 450VDC.

•DCA window settings - view DCA window settings - these settings should not be edited.

•Detector status - allows the service engineer to view the detector status real time - information displayed includes Peak setting Bias setting, and DCA window settings.

•Detector AGS Tab

•AGS DAC control (verify AGS DAC settings), check on detector rollover, and check on channel count rates.

DO NOT adjust the detector Bias, DCA windows or AGS DAC settings - changes in the Detector bias, DCA windows or AGS DAC’s can change the scanner’s results.

•AGS Mode - the operate / calibrate signal (disables the AGS systems so that the detector can be peaked correctly) can be toggled.

3.2.7 Scanner X-ray•X-ray Tests Tab-

•Manual Test - Control Manually the Shutter, X-ray on Indicator and patient Positioning laser

•Automatic test - automatically toggle the Shutter, Laser and X-Ray Relay

•X-Ray Source - Turn on source (ramp and make x-rays), warm up a tube head at install or replacement.

•X-ray cycle test - cyclically ramp the source - (can be used to test ramping failures or for arcing)

•X-rays Tab

•Ramp the kV and / or the mA of the x-ray generation system and view feedback real-time. Faults are displayed and polled real-time in the window on the right.

•Ports Tab - view status of and send commands to (c)SBC ports (see section 2.4 for (c)SBC port definitions).

•Download Tab - identical to Set Download Parameters (section 3.1.7)

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•Misc. Tab- not used for service.

3.2.8 Lin/RepNot Used for Service

3.2.9 Limit Switch AdjustmentVerify and Adjust Limit switch positions.

Note: When using Limit Switch Adjustment, DO NOT alter the default settings.

3.2.10 Scanner Disconnect Disconnect the scanner from the PRODIGY software (reset the (c)SBC).

3.3 Diagnostic Scan Modes -Performed under F2 Measure - only visible when the scanner is in service mode.

3.3.1 Table Top Scan -Not used in Service

3.3.2 Alignment ScanVerify that the Source and Detector maintain a constant count rate in all areas of the scan table. Also useful for testing cables.

3.3.3 Beam Wobble scanQuantifies beam movement relative to the detector when the scanners mechanics are moving (see DXAP2010 Chapter 5 Appendices).

3.3.4 Hacksaw Calculates and sets correcton factors to align bone edges in scans (see DXAP 2007 Chapter 5 Appendices).

3.4 Error Log• The PRODIGYwill maintain an error log file whenever the scan table is in

operation. All errors, fatal or nonfatal will be logged here. The Error log gives a brief description of the error and if possible the origin of the fault.

• The error log is one of the best troubleshooting tools for scanner malfunction.

Note: To aid in a quick and accurate response when requesting assistance from GE-LUNAR, please have an error log available for review by GE-LUNAR Customer Support.

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The error log file is named errorlog.bin, this file is the current error log session. Older sessions are named errorlog.1, errorlog.2 and so on up to errorlog.4.

When requesting help from GE-LUNAR, E-mailing the current error log file and a description of the symptoms will aid in a rapid diagnosis (see Copy Configuration in section 3.1.10 for information on copying the error log to an E-mailable file).

3.4.1 Printing the Error Log.Note: The scanner does not have to be in Service mode to view or

print the Error Log.

• The Error Log is located under the Tools dropdown menu. Left click on Tools / and then on Error Log.

Figure 3-2. The Error Log Dialogue Box

• Session - The PRODIGYsoftware will maintain up to 10 “sessions” - each session is up to 100 errors.

•A new session is created by shutting down and restarting the enCORE software. A new session may also be started by clicking on the button

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•To view a session, left click on it, all errors (if present) will be shown in the box below.

•The Errors list may be printed (click on print errors) or it may be searched with the Find Error button.

•The details of the failure are shown when the error is highlighted and then right clicked on.

Figure 3-3. Error log entry details

3.4.2 Troubleshooting Help softwareThis feature is found in software versions 2.26 and greater. When an error is highlighted and the Troubleshoot button is clicked on, it opens an online enCORE troubleshooting guide to assist the service engineer in troubleshooting the system by error code.

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Figure 3-4. enCORE Troubleshooting help screen capture.

How to use the Troubleshooting Help software:

This Help software is based on Fault Tree Analysis or FTA. The fault trees are in an outline form. Each heading in the outline represents an “or” choice. For example, the basic fault below “Shutter will not close” has three possible causes: “Shutter stuck”, “Solenoid Return Spring not working”, or “Solenoid powered when it should not be”. Each of these in turn lists their possible causes.

Sample Fault Tree (from Prodigy Collimator):

Shutter will not close

I.Shutter stuck – move by hand to test

A.Slotted Wheel scraping OMI board

B.Shutter scraping Shutter Plate

II.Solenoid Return Spring not working – move by hand to test

A.Spring broken

B.Spring no longer anchored

III.Solenoid powered when it should not be

A.FOINK (PRODIGY I) problem – Test by disconnecting J1. If the shutter closes, swap the SBC. If the shutter stays open, swap the FOINK.

B.(c)SBC problem – Test as above.

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to be reproduced, distributed, used or disclosed, either in whole or in part, except as specifically authorized by GE-Lunar Corp.

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Note: This type of analysis is meant to identify all possible causes, giving the user a complete list to work from when ruling out possibilities. If a cause is not listed in the appropriate fault tree analysis, please e-mail GE-LUNAR about the discrepancy.

3.4.3 Reading the Error Log

Figure 3-5. Sample PRODIGY Error Log

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4 1112Troubleshooting

Chapter 1:Troubleshooting This chapter contains troubleshooting techniques for diagnostic failures, failing quality assurance tests, mechanical failures and imaging problems.

4.0 Diagnostic Failure Codes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1194.1 Transverse Motion failure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-119

4.1.1 Operator Induced - switch closed during scan . . . . . . . . 4-1194.1.2 Mechanical Failures - Unusual noise or irregular motion 4-1194.1.3 Loss of OMI signal. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-121

4.2 Longitudinal Motion failure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1224.2.1 Limit Switch Tripped During a Scan . . . . . . . . . . . . . . . . 4-1224.2.2 Longitudinal Binding . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1234.2.3 Loss of OMI Signal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-125

4.3 Failure of the 28V power supply . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1264.4 Emergency Stop Button . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1274.5 Tube Head Thermostat. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1274.6 Communication Error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1274.7 Other Diagnostic Failure Codes . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-127

4.7.1 Reasons For Invalid Diagnostic Failures. . . . . . . . . . . . . 4-1284.8 Failing Quality Assurance Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-128

4.8.1 Block Position . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1284.8.2 Beam Stop Action . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1284.8.3 Mean% Spillover . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1284.8.4 Reference Counts and Ratio . . . . . . . . . . . . . . . . . . . . . . 4-1294.8.5 Ratio Fluctuations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1294.8.6 Transverse or Longitudinal Mechanics . . . . . . . . . . . . . . 4-1294.8.7 Tissue Value . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1304.8.8 Bone Mineral of the Standard Chambers . . . . . . . . . . . . 4-1304.8.9 Symptoms of High and Low KV. . . . . . . . . . . . . . . . . . . . 4-131

4.9 Reference Counts. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1314.10 Arcing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-134

4.10.1 Limit Switch Tripped During Scan . . . . . . . . . . . . . . . . . 4-1354.11 Imaging Problems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-136

4.11.1 White, or Grey in the first or second scan line: . . . . . . . 4-1364.11.2 Femur Scan Problems. . . . . . . . . . . . . . . . . . . . . . . . . . 4-1364.11.3 AP-Spine Image Problems: Probable causes . . . . . . . . 4-137

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4.11.4 Broken Signal Cable . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1374.11.5 Loss of tube head current . . . . . . . . . . . . . . . . . . . . . . . 4-1374.11.6 X-Ray Relay Failure. . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1374.11.7 Unstable AC Line . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1384.11.8 Arcing. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-138

4.12 Failing Alignment Test Results . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1384.12.1 Image. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-138

4.13 Indicator Failures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1404.13.1 X-ray On LED Blinking. . . . . . . . . . . . . . . . . . . . . . . . . . 4-1404.13.2 Shutter Open LED Blinking . . . . . . . . . . . . . . . . . . . . . . 4-1404.13.3 Shutter Not Operating . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1414.13.4 End of Exposure Alarm During Scan. . . . . . . . . . . . . . . 4-141

4.14 Communications Failures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1424.15 Viewing Quality Assurance Trends . . . . . . . . . . . . . . . . . . . . . . . . 4-142

4.15.1 What to Look for in the QA History . . . . . . . . . . . . . . . . 4-1434.16 MAX Board Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1434.17 FOINK Board Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1444.18 OMI Board Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1454.19 SBC Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1454.20 XORB Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1474.21 Detector Motherboard Troubleshooting . . . . . . . . . . . . . . . . . . . . 4-1484.22 Detector Daughter Board Troubleshooting . . . . . . . . . . . . . . . . . . 4-149

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4.0 Diagnostic Failure CodesThe following conditions halt the operations of the scanner, and generate a diagnostic failure message which is displayed on the monitor screen:

All of these interrupts are detected by the cSBC

• Transverse Mechanics Failure (4.1)

• Longitudinal Mechanics Failure (4.2)

• Emergency Stop Button activated (4.3)

• X-ray source over temperature (4.4)

• DC power supply failure (4.5)

4.1 Transverse Motion failureMotion Detection

• cSBC / OMI fail to see transverse motion during a patient scan, an interrupt signal is generated and the cSBC resets and closes the shutter.

• A slotted disk at the end of the arm rotates through an infrared beam (OMI), and pulses are sent to the cSBC board when there is transverse motion.

• The transverse and longitudinal motion detection system (on cSBC) is operational during patient scans and the “find block” test of the daily QA. If the problem occurs during a quality assurance, it may be high voltage arcing or a problem with the OMI.

4.1.1 Operator Induced - switch closed during scan• Cause: When scanning, a defect in the transverse mechanics or a mis-

positioned patient may cause one of the transverse limit switches to close when the scanner is acquiring data. Closure of a limit switch prevents further operation of the motor. The shutter will close, the shutter open lamp will go out and the end of exposure alarm will sound. Seconds later the error message will appear on the screen.

Solution: If the patient is not centered on the table top or if the region being scanned is too close to a limit in transverse travel, the limit switch switch may be close while scanning. Re position the patient on the table, further away from the limit.

4.1.2 Mechanical Failures - Unusual noise or irregular motion

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If the Detector / Tube Head motion is irregular, or scraping noises are heard, the Transverse Mechanics may be binding. This symptom will typically be detected as a failure by the daily QA Mechanics Test.

• Symptom: If the Detector Array / Tube Head is not moving when scanning check:

• Mechanics are free to move

• Centent

• Stepper Motor

Troubleshooting Binding

Turn off the power to the scanner and move the affected parts by hand. Feel the motion for spots where the carriages are more difficult to move. Listen for unusual noises.

The following are common causes for Transverse Binding

• High Voltage Cable Routing

One of the most common problems is a failure of the Source and Detector to reach the rear Limit Switch due to the Tube Head running into its own high voltage cables. These cables must have a hump formed at the Rear Longitudinal Carriage that allows the lower portion of the Tube Head to pass under the cables.

The High Voltage Cables can also impede transverse motion toward the front Limit Switch. This is caused when the cables have been tied down without enough play for the Tube Head and Detector to move all the way forward. These problems should be investigated by manually tripping both Limit Switches while inspecting for cable conflicts, binding, or tension problems.

• Check to see that the bottom of the Tube Head is not hitting the Transverse Centent

• Wiring

In rare instances, the wires from the Shutter Solenoid and/or Fans can snag on the bolts that protrude through the frame on the foot end of the scanner. This is solved by properly tying down these wires.

• Transverse Belt

The Transverse Belt should not be excessively tightened or this will cause excessive binding in the transverse mechanism. It should be possible to deflect the belt by 4 cm when it is properly tightened. Sometimes the spare belt material near the clamp on the Tube Head Carriage comes into contact with the forward gear and prevents the scanner from going all the way to Home position.

• Drive Wheels

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The wheels that support the Tube Head and Detector Carriages must be adjusted so that they come into perfect contact with the Transverse Rails. These wheel are best inspected with the table top, front panel and arm covers off so one can sight down the extrusions. However, it is possible to test the wheels by preventing any wheel from turning and seeing if the carriage will still move. By preventing any wheel from turning, you should be able to tell that it slides along the extrusion while the others roll. This indicates that the wheel has not been excessively tightened down. This is least likely to be the source of transverse motion problems, as it is unlikely that the adjustment of the wheels would have become any tighter over time. They would be more likely to loosen over time and fail alignment tests (see Alignment Test, section 4.12). Adjustments can be made by loosening and rotating the eccentric bearings of any of the lower wheels.

• Gear And Pulley Positioning

Check all appropriate gears and pulleys. Verify that the set screws are tightened and the gears and pulleys are not out of position.

• Limit Switch Positioning

If the transverse motion seems to be acceptable, but the number of steps in the Quality Assurance Test is failing, check the position of the Limit Switches.

On Total Body scans, a limit switch out of position could allow the Source/Detector Carriages to hit the frame or panels before the Limit Switch is actuated.

• Transverse Motor

Check the Transverse Motor for a broken wire in one of the internal coils, or a bad electrical connection to its Centent Motor Controller.

• Transverse Centent

The Centent Motor Controller, if defective, will cause transverse motion problems. Sometimes the controller works well enough to acquire some scans, but it will not provide enough torque to complete every fast scan. The CURRENT SET voltage at terminal 11 on a properly operating controller should be 14 to 16 VDC (transverse motor wired in parallel).

The longitudinal and transverse Centents are identical, and can be exchanged. If the problem remains, the Transverse Motor should be replaced.

4.1.3 Loss of OMI signal If the error occurs consistently on the first line of a patient scan or during the find block portion of the daily QA, and the scanner is moving in the transverse direction, then check the following:

Cause: The Interrupt signal is being lost.

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Solution 1: The pulses that normally enter the cSBC board at J14 (the black wire at the center of the connector) may have stopped. These pulses are necessary to keep the cSBC from resetting. These pulses can be seen on a cSBC board LED.

Use the DPX-NT service software (Tools/Diagnostics/Scanner Motion / Motion Commands Tab) to set the joystick speed to 50 steps, enable the joystick and watch the LED. If the OMI is working the LIght will flash when the Transverse Motor is run. If the LED flashes when the mechanics are engaged, but the error still occurs, the interrupt was invalid. Check for arcing in the high voltage system or replace the cSBC.

If the LED D9 (B in figure 4-1) does not flash,

• Verify that the slotted disk at the front of the lower arm rail is in the middle of the slot between the photo diode and photo transistor.

• The slotted disk must be completely flat and remain in the center of the sensor slot during its entire rotation.

• If the slotted disk has been in physical contact with the optical sensor, the sensor may have debris on it, disassemble this mechanism, and clean the sensor and the slots of the disk.

• Check the Cable running from the cSBC to the OMI for a cable break by checking the individual wires for continuity.

4.2 Longitudinal Motion failure• cSBC/ OMI fail to see longitudinal motion during a patient scan, an

interrupt signal is generated by the cSBC which resets and closes the shutter.

• A slotted disk at the foot end of the table on the pulley for the Longitudinal Drive Belt rotates through an infrared beam (OMI), and pulses are sent to the cboard when there is transverse motion.

• The transverse and longitudinal motion detection system (on FOINK) is operational during patient scans and the find block portion of the daily QA. If the problem occurs during a quality assurance, for instance, it may be the high voltage system is arcing or the OMI may be malfunctioning.

4.2.1 Limit Switch Tripped During a Scan

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• Cause: When scanning, a defect in the longitudinal mechanics (binding) or a mis-positioned patient may cause one of the longitudinal limit switches to close when the scanner is acquiring data. Closure of a limit switch prevents further operation of the motor. The shutter will close, the shutter open lamp will go out and the end of exposure alarm will sound. Seconds later the error message will appear on the screen.

Solution: If the patient is not centered on the table top (length wise) or if the region being scanned is too close to a limit in longitudinal travel, the limit switch may be close while scanning. Re position the patient on the table, further away from the limit.

4.2.2 Longitudinal Binding• If the scan arm fails to move when scanning check the stepper motor,

and Centent, if arm motion is irregular, check for binding.

Turn off the power to the scanner and move the affected parts by hand. Feel the motion for spots where the arm is more difficult to move. Listen for unusual noises.

When moving the arm longitudinally, only push on the arm column. Pushing on the forward parts of the arm can ruin Tube Head/Detector alignment.

• Cable Track

The major impediment to longitudinal motion is the plastic Cable Track that runs through the trough at the rear of the scanner.

This track is attached at two points: at the Rear Longitudinal Carriage and to the scanner frame (low, rear and center) each spot by 4 bolts. Also, adequate slack must be left in the cables inside the Cable Track or they will stop the arm from moving fully to the foot end.

Should the Cable Track detach from the scanner frame, it will slide freely in the trough and will eventually cause trouble. This can allow the Cable Track to get in between the Rear Longitudinal Carriage and the scanner frame on the foot end preventing the tripping of the limit switch.

• Front Longitudinal Carriage Dragging

Check the distance between the front longitudinal carriage and the longitudinal rail with a go/nogo gauge (See installation Procedure DXAP2000 Chapter 5 appendices). The carriage should not rub the front rail, if necessary insert shims behind the front longitudinal carriage.

• Tube Head Cable Routing

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Problems at the head end of the scanner can be caused by a limit switch being out of position (thus the arm runs into the frame before the Limit Switch) or because the High Voltage Cables are tied down incorrectly where they snake around from the Rear Longitudinal Carriage to the panel under the Tube Head (High Voltage Cable Trough). If the cables are tied down too far toward the head end (at the point where the three tie downs are), they can run into the Longitudinal Motor Assembly and hold the arm away from the head end Limit Switch.

• Slip Clutch

A slip clutch is part of the longitudinal motion system to limit torque. This is a feature to protect the patient should he/she pinch an arm or leg between the back side of the scanner and the Arm Column. If the Slip Clutch is set too loose, it will fail to move the belt and will just "slip" as the motor turns. This may produce the following symptoms:

• failure of Quality Assurance scan Mechanics test

• compressed image in limited areas of the image

• a Longitudinal Mechanics diagnostic failure

• Gear and Pulley Positioning

Check all appropriate gears and pulleys. Verify that the set screws are tightened and the gears and pulleys are not out of position.

• Limit Switch Positioning

If the longitudinal motion seems to be acceptable, but the number of steps in the Quality Assurance Test is failing, check the position of the Limit Switches.

On Total Body scans, a limit switch out of position could allow the Source/Detector Carriages to hit the frame or panels of the scanner before the Limit Switch.

If the mechanical stop is reached before the Limit Switch is actuated, check carefully to see which part of the Arm Assembly is in contact with the Table Assembly. The front part of the Lower Transverse Extrusion is clamped to the Longitudinal Drive Cable at the front of the scanner. If the Lower Transverse Extrusion is not clamped in such a way that it forms a 90 degree angle with the length of the table, the rollers at the front end of the Lower Transverse Extrusion may strike the end of the scan table before the Limit Switch is actuated.

• Longitudinal Motor

Check the motor for a broken wire in one of the internal coils, or a bad electrical connection to the Centent Motor Controller.

• Longitudinal Centent

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The longitudinal Centent Motor Controller may be the cause of a failure. The current set voltage should be roughly 9-11 volts at terminal 11 on a properly operating controller. If this voltage is not correct, replace the Centent Controller.

The longitudinal and transverse Centents are identical, and can be exchanged. If the problem remains, the Longitudinal Motor should be replaced.

• Longitudinal Belt

The Longitudinal Belt should not be tightened too much or this will cause the brackets holding the gears to deform at either end of the scanner. When the belt is properly tightened, it should be possible to deflect the upper and lower sides of the belt so that they touch within 8 cm of the gears at either end.

• Drive Wheels

The rollers in front and the wheels in back that support the Arm must be adjusted so that they come into perfect contact with the Longitudinal Rails. Test them by preventing any wheel from turning and see if the carriage will still move. By preventing any wheel from turning, it should be possible to slide the carriage along the rail with one wheel dragging while the others roll. This indicates that the wheel has not been excessively tightened down. Adjustments can be made by loosening and rotating the eccentric bearings of any of the lower wheels.

4.2.3 Loss of OMI Signal• If the Scan Arm motion is irregular, or scraping noises are heard, the

Longitudinal Mechanics may be binding. This symptom will typically be detected as a failure by the daily QA Mechanics Test.

If the error occurs consistently after the first line of a patient scan, and the scanner is moving in the longitudinal direction, then check the following:

• Cause: The Interrupt signal is being lost.

Solution 1: The pulses that normally enter the FOINK board at J (the black wire at the center of the connector) may have stopped. These pulses are necessary to keep the FOINK board from sending an interrupt to the SBC. These pulses can be seen on a FOINK board LED.

For LED location see figure 4-1. Use the DPX-NT service software (Tools/Diagnostics/Scanner Motion / Motion Commands Tab) to set the joystick speed to 50 steps, enable the joystick and watch the LED. If the OMI / FOINK is working the LIght will flash when the Longitudinal Motor is run. If the LED flashes when the mechanics are engaged, but the error still occurs, the interrupt was invalid. Check for arcing in the high voltage system or replace the FOINK and SBC.

If the LED does not flash,

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• Verify that the slotted disk at the foot end of the scan table is in the middle of the slot between the photo diode and photo transistor.

• The slotted disk must be completely flat and remain in the center of the sensor slot during its entire rotation.

• If the slotted disk has been in physical contact with the optical sensor, the sensor may have debris on it, disassemble this mechanism, and clean the sensor and the slots of the disk.

• Check the Cable running from the FOINK to the OMI for a cable break by checking the individual wires for continuity.

4.3 Failure of the 28V power supplyThe 28 VDC power supply is only enabled when the X-ray tube is ramped, use the service software (Tools/Diagnostics/ Scanner X-ray) to attempt to ramp the Tube Head.

When the Supply is ramping the Red and Green LED’s on the MAX board will light.

If the LED’s illuminate and the go out:

• Measure the output of the 28VDC power supply, and verify that it remains constant during the voltage ramping and scanning operations.

• Check the High voltage power supplies, insure they are not arcing (Error Log - see section 3.2) and are ramping.

If the LED’s fail to light:

• This supply is turned on by the X-ray Relay, so verify that the Relay is closing. If not, then either the Relay is bad or it is not receiving the signal from the SBC via the FOINK.

• Check the continuity of the cathode, the filament may have broken, MAX board TP 4, TP 5 and TP 13 should be continuous with the Tube Head control cable connected.

• The Tube Head Thermostat is wired in series with the Relay, so if it has opened, the Relay will not be able to close.

• The 28VDC should also be measured at the Terminal Block. If not, check the continuity of the wiring and refasten all connections. Also, check the wire tie-downs for excess tension they may be putting on the wires.

• It may be necessary to check the wiring from the Terminal Block to the MAX board and to the High Voltage Power Supplies.

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4.4 Emergency Stop ButtonThe Emergency Stop button is a normally closed circuit, if it opens the Emergency Stop interrupt will be sent from the FOINK to the SBC.

• Verify that the emergency stop button is out. If it has been pressed in, press it again to release it.

• If 26VDC can be measured on both pins of FOINK connector J17, the Emergency Stop Switch and the wires connecting it to the FOINK board are good and the FOINK board should be replaced.

• If 26 VDC is missing, the Circuit is open between the FOINK and the Switch.

• Insure the switch is functional

• Check the continuity of the wires from the switch to the FOINK board.

4.5 Tube Head ThermostatThere is a thermostat inside the Tube Head. This thermostat is normally closed, but opens when the Tube Head temperature is too high.

• The thermostat will close again automatically after a cool down period of usually less than 30 minutes. If 0 VDC is measured on both pins of FOINK connector J15, the Thermostat and the wires connecting it to the FOINK board are good and the FOINK board should be replaced.

4.6 Communication ErrorThe computer is not communicating with the SBC board.

Verify communications with the SBC in the service software (Tools/Service Options Comm tab - Test Communications).

If this is unsuccessful, verify that the I/O cable from the computer to the SBC Board is secure. Also, verify that the comm port is configured correctly (see DXPC 2000 Chapter 5 appendices) and that all required drivers are present. If all fails, the SBC or computer serial port is defective.

4.7 Other Diagnostic Failure Codes

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Multiple error codes are possible. These will be displayed one after the other, but the first one displayed is probably the problem. The Error Log will always show the failures in the correct order, the others are generated as a result of the first failure.

4.7.1 Reasons For Invalid Diagnostic FailuresArcing of the x-ray high voltage system releases a large amount of electromagnetic energy. This energy creates noise in the electronic circuits and may cause the SBC to do unpredictable things, such as give invalid diagnostic errors. Arcing is usually accompanied by white, blue or black lines across patient scans (See Arcing, section 4.10).

4.8 Failing Quality Assurance TestSee chapter 2 section 12, for explanations of the various tests that are performed during the running of the Daily Quality Assurance.

If any of the QA test results fail, none of the results are considered valid. The results will be stored in the Quality Assurance History file, but these values will not be averaged with the other results for calibration purposes. In addition, the software will prevent patient scans until a passing daily QA has been completed. Recent valid QA's are necessary for accurate results.

4.8.1 Block PositionAfter starting a QA, the operator is prompted to place the QA standard n the table, if the DPX-NT fails to detect the Block in the correct orientation the QA will not progress.

• Check Block position and orientation

The scanner may not be finding the correct "Home" position. The correct "Home" position aligns the center of the x-ray beam with the center of the Brass Piece when the Standard is correctly positioned. The Air Counts must be obtained outside of the QA standard, next to the Brass Piece. If the Reference Counts are obtained with the x-ray beam passing through the Brass Piece, the Quality Assurance Scan will fail.

• Verify that the scanner limit switches are set correctly with the DPX-NT home position jig (see DXAP2000 - DPX-NT Installation Procedure Chapter 5 appendices).

4.8.2 Beam Stop ActionThe Beam Stop Action test verifies the ability of the lead shutter to attenuate x-rays from the tube head by verifying that the Background counts when the shutter is closed are lower than counts taken through the brass piece with the shutter open.

4.8.3 Mean% Spillover

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An increase in the Spillover percentage over time is an indication that the detector is losing resolution, even if the Spillover test does not fail. A large change in the Spillover can be explained in some cases by standard positioning (or a small change in the home position of the scanner). If the beam is not fully eclipsed by the brass piece during the Spillover test, the Spillover value increases dramatically.

Spillover stability is a test of detector bias drift. if the detector bias is drifting, the mean spillover value will also drift.

4.8.4 Reference Counts and RatioDuring this test the baseline is established which will later be used for comparing with the values obtained during the scan of the standard. Care should be taken that the x-ray beam is not missing the standard, nor being obstructed by the brass piece on the standard during the High and Low Air Count test.

The Ratio value should remain fairly constant over time.

4.8.5 Ratio FluctuationsThe ratio of High to Low Channel Air Counts is the way the bone density measurement is calculated by the changes in the ratio of High to Low Channel counts. The Ratio should remain constant as long as the x-ray beam quality and the resolution of the detector remain constant.

It is possible to view the Ratio trends in the Quality Assurance History. Check both the 3mA Ratio and the 150 Ratio to determine if the either Ratio has changed significantly.

The problems which could cause a change in air ratio are:

· deterioration of the resolution of the detector

· current leakage through the transorbs on the XORB board

· a faulty High Voltage Power Supply (kV unstable over time)

· changes to the x-ray tube insert

These are very difficult to diagnose by a method other than substitution of new components until the Reference Counts Ratio returns to normal.

Detector deterioration or unstable High Voltage Power Supply, will usually cause the Alignment Test Scan to fail.

The specification for XORB Board transorbs is that they must allow less than 0.5 micro amperes reverse bias current. At LUNAR, each transorb is measured by applying a 5 Volt reverse bias to the transorb and a 100 kW 1% resistor connected in series. The voltage measured across the 100 kW resistor must then be less than 50 mV.

4.8.6 Transverse or Longitudinal MechanicsFailure of this test is caused by one or more of the following:

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• Incorrect Limit Switch positioning

• Defective Limit Switch

• A mechanical constraint

• A defective Motor

• A defective Centent Motor Controller

The values recorded for these tests should remain fairly constant over time. Variations between QA's of under 25 steps should not be a cause for concern as 1 transverse step = 0.05 mm and 1 longitudinal step = 0.1 mm, so the actual variation is only a few millimeters.

If the number of steps continually increases from QA to QA, this could indicate an impediment to the scanner's motion and should be rectified (see 4.1 (Transverse) or 4.2 (Longitudinal)).

4.8.7 Tissue ValueThe tissue value should not be the sole failing parameter. The failure of this test is usually accompanied by problems with Bone Mineral values (see below) or Reference Counts Ratio trends (see above). If this is failing alone it is probably a problem with the counting system or high or low kV (4.8.9).

4.8.8 Bone Mineral of the Standard ChambersThe software contains values which it expects the scanner to measure for the scan of each chamber. If the mean of the BM measurements made for the chamber does not fall within the predefined software limits the QA will fail. If the percent coefficient of variance is over 3%, the QA will fail.

These failures will always occur if the Reference Counts or Reference Ratio test have deviated severely from normal results. However if the Reference Count results look normal, and the values are approximately equal to the numbers obtained during the scanner installation, then the counts may be unstable.

Another cause of failing on the bone chamber measuremnts can be arcing during the QA. This can be detected by examining the QA History graphically and looking for variation of the Large BM values. Note the few data points that vary. These are the early signs of arcing.

This will also be apparent (but not obvious) on the QA Results printout. The arc occurred in the third standard scan and elevated the BM values. If a customer reports a failing QA because of a bone chmaber measurement being too high, be aware that this could be an early warning of arcing. Obtain from the site the QA history file and error log for analysis. Look for variation of the Large BM values.

It is very important to notice these early warning signs of arcing so that the system can be re-greased before any damage is done to the high voltage cable connectors or the tube head.

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4.8.9 Symptoms of High and Low KVIt has been noted in a small number of cases that defective high voltage power supplies, or an arcing tube head may produce a voltage other than 76 kV. The DPX-NT monitors kV once per scan sweep.

Note: :It would be prudent in both of these cases to take a positive and negative power supply, AND a tube head. Also, the XORB test points may look normal (indicating 76 KV) in each case as well. This usually occurs where the power supplies are defective and so the monitor voltages returned to the XORB may not show the true voltage. When the tube head arcs causing the voltage to go too high, then the XORB test points may indeed show the actual voltages.

4.9 Reference Counts4.9.1 Unstable Counts

To examine the scanner's ability to count detector pulses consistently over longer periods of time, run the Alignment Test option from the service software program.

• If the "End of Exposure Alarm" rings during the time the Alignment Test scan is running, see "Alarm Pings During Scan" in section 4.13.4. If the Shutter Open or the X-ray On lamps on the front panel blink, during the test, see section 4.13 also.

• While the Alignment Test scan is running, measure the voltage at test points 1, 2, 5 and 6 of the XORB board. They should have approximately the following values respectively: -0.150VDC, 3.8VDC, 0.150VDC, and 3.8VDC.

• A pure DC voltage on an oscilloscope at test point 1 and 5 of the XORB will verify that there is constant current through the filament of the X-ray Insert.

• If there is AC ripple in excess of 0.2 Vpp, the power supplies should be replaced.

• Start and stop the x-rays several times while observing the voltage at TP3 and TP7 of the XORB board. This is the programming voltage from the SBC, and although this voltage is dependent on the feedback information returned to the SBC, the voltages at the XORB board test points should be approximately the same each time the x-rays are produced. The AC ripple on this signal must be less than 0.2 Vpp. Replace the SBC board if the proper control signal is not present.

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• When the x-rays are off between scans, verify that the shutter aperture lines up with the aperture to the Tube Head beneath. Take some alignment pictures and verify that the image is a bright, rectangular image and the entire alignment box is visible. If the alignment box is not visible, the shutter Tube Head and detector apertures are not aligned.

• Open and close the shutter to make sure that it returns to the same position each time. Turn the x-rays back on, and make sure that you obtain nearly the same count rate each time the shutter is opened.

4.9.2 No CountsWhen the table to the right of the peak graph on the Quality Assurance Results printout is entirely filled with zeros, use the Signal monitor program in the Diagnostics (see section 5.1) to create x-rays at 76 kV and 150 uA and open the Shutter for sampling. Then check the following items:

I.Is the amber X-ray On LED illuminated?

A.If it is, skip to part II.

B.If not, the voltage or current ramping has probably failed. Are both the red and green LED's on the MAX Board illuminated?

1.Voltage or Current Ramping Failures

If not, is the red LED illuminated?

a.X-ray Relay or FOINK

If not, measure the output of the 28 Volt Power Supply. Check the operation of the X-ray Relay or the FOINK Board which controls its operation. If all of the above are working, the red LED may be defective.

b.MAX Board Fuse

If so, the fuse is blown on the MAX Board (see section 4.16).

2.If the red and green MAX Board LED's are illuminated, verify the following test point voltages:

a.Current Ramping Failure

• XORB TP1 is approximately 0.150 VDC. If incorrect, go to step d. If this test point is correct, verify that XORB TP5 is also approximately 0.150 VDC. If this voltage is incorrect, substitute a new Positive High Voltage Power Supply.

b.Voltage Ramping Failure

• XORB TP2 and XORB TP6 are approximately 3.8 VDC. If these voltages are incorrect, verify that the voltages on XORB TP3 and XORB TP7 are approximately 3.8 VDC. If TP3 and TP7 are not equal the XORB jumper at J26 is set in the wrong position. If they are equal but incorrect, test the cable from the SBC to XORB, or substitute a new SBC Board.

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c.X-ray On LED

Test the X-Ray On LED by inserting it into the Power On receptacle. Replace if defective.

d.High Voltage System

• Current ramping has failed. If TP1 and TP5 are zero and do not change, check the polarity of the High Voltage Cables. The X-ray Insert is essentially a diode, and will not conduct current from the anode to the cathode.

• If either of the test points is at 1.0 VDC, the High Voltage Power Supply is delivering as much current as it possibly can, and has automatically limited the voltage.

• Check TP2 and TP6. If the voltage is approximately 3.8 VDC, the voltage has been set properly.

Feel the heat sinks on the back of the High Voltage Power Supplies. If one of the power supplies is cold, this is usually the defective one. If one is warm and the other is hot, replace the hot one. The best troubleshooting technique may be to substitute power supplies.

• If either TP2 or TP6 are incorrect, the possibility exists that one of the High Voltage Cables or the Tube Head is shorted. The short may be possible to find with an ohm meter, but often it takes several kV to break down the defective component. It will be difficult to troubleshoot this problem by any method other than part substitution.

Do not attempt to ramp the power supply above 50 kv without a cable connected, or arcing will occur near the connector.

• Ramping between 40 and 50 kV is a good way to determine whether the power supplies are able to increase voltage from 0 to 50 kV.

4.9.3 Decreasing Reference CountsA long term, continuous decrease in the Reference Counts unaccompanied by a change in Reference Ratio is a serious problem. A count rate of at least 500,000 Low Channel Reference Counts is necessary to maintain precision of results when scanning thick patients. Reference Count values should change by less than 10% from the day of installation. The possible causes are:

I.Lead Filings - Shutter Wear

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A rough edge around the shutter aperture may be wearing away on the tube head below. The lead filings fall off the shutter aperture and gather on the filter below, causing a reduction in x-rays over time. Any wear should be easily visible on the underside of the shutter paddle. If there is visible wear, the lead dust must be removed from the top of the filter. The Collimator assembly must be removed, the filter cleaned, and then the Collimator assembly reinstalled and realigned.

II.A Change in Current Control Settings

Use the Signal monitor option of the service software program to produce x-rays (Tools/Diagnostics? Scanner X-Ray). Select 76 kV and 750 µA operation.

• Verify that the SBC is properly controlling the current. TP11 of the MAX board should be approximately 0.75 volts. This voltage is dependent on feedback information from the power supplies, which makes it difficult to troubleshoot by any means other than SBC substitution.

• Check the current through the X-ray Insert. The absolute value of the voltage at test points 1 and 5 on the XORB board is proportional to the current through the X-ray Insert. 1 millivolt is equal to 1 micro-ampere of current. A current setting of 750 µA should give a reading of 0.750 VDC at test points 1 and 5. If either of these voltages vary from the expected by more than 10 millivolts, the MAX board could be at fault. If TP1 and TP5 are more than 15 millivolts apart, substitute new high voltage power supplies.

4.10 ArcingThe X-ray Tube Head Insert is an evacuated glass enclosure. An AC current is applied to the filament inside the insert. It glows like the filament in a light bulb, and electrons are boiled off into the evacuated space. A high voltage is applied between the anode and the cathode causing electrons to rush toward the anode, striking it and creating x-rays. As long as the insert is properly evacuated, there can be no internal arc. However, no insert can be totally evacuated and impurities can be ionized creating a lightning like effect; arcing. During the arc the resistance of the insert is dramatically decreased and a large amount of current flows.

• The significant amounts of electromagnetic energy released inside the scanner can cause problems with the electronics of the scanner system and may result in abnormal operations of the scanner. An arcing scanner will have one or more of the following symptoms:

• complete lock up of the system

• a diagnostic error code message which is undefined or inappropriate

• a vertical stripe or artifact in the image of the patient's scan (effects all 16 detectors at once)

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• Transverse Motion Failure message.

To specifically locate the source of an arc, it is necessary to find out which high voltage power supply provides the excessive current. This may be done by recording the power supply current monitors at TP1 and TP5 of the XORB board with a storage oscilloscope. An arc typically draws 1.5 mA from the power supply for about 1 ms. The trigger voltage should therefore be set at 1.5V for TP1 and for TP5.

• Arcing can also occur inside the high voltage connectors. This will usually result in a plainly visible black or brown carbon track through the grease on the connector. In any case, once the high voltage connectors have been removed from the Tube Head and the power supplies, they should not be re-connected without first being cleaned and regreased (see procedure DXSE0002 in the chapter 5 appendices).

• After cleaning the old grease off of the connectors, they should be carefully inspected for carbon tracks. Look for these tracks on both the rubber cable connectors and on the phenolic sockets of the Tube Head. If such tracks are found after cleaning, the following are the options for returning the scanner to service:

• If carbon tracks are found on the rubber cable connectors, they can be removed by excising the damaged section with a sharp blade. Severe tracks can burn quite deep into the rubber, so care must taken to remove all the damaged rubber. After the carbon tracks have been removed, additional grease must be used when repacking the connection to fill in the volume of the removed rubber.

• If the above procedure requires too much rubber to be removed, or the carbon track looks very severe, another option is to replace the high voltage cable.

• Arc tracks will be impossible to see on the sockets in the Tube Head. Therefore, if arc tracks are seen on the rubber cable connectors, the sockets should be sanded with emory cloth as a precaution. After sanding the socket, remember to flush the socket with cleaning solution to remove any particles.

• If the tracking inside the socket is too severe or the carbon track cannot be removed, another option is to replace the Tube Head.

Note: IT IS VERY IMPORTANT TO REMOVE ANY CARBON TRACKS ON THESE SURFACES! Carbon tracks that are simply covered by grease or not completely removed will still provide a path for arcs to follow.

4.10.1 Limit Switch Tripped During ScanIf a Limit Switch is tripped during an install test, verify the Limit Switches' location with the Service Software (Tools/Diagnostics/Scanner Motion). If this problem occurs any time after install, see the problem description below.

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If the transverse mechanics of the scanner become imprecise, it may cause a Limit Switch to be tripped during a scan. This will usually only happen during a total body scan or during an Alignment Test test since both of these scans involve full-width scanning. Once the switch is closed, the motors stop, the End-of-Exposure Alarm sounds, the amber SHUTTER OPEN lamp turns off and after a few seconds a Diagnostic Failure appears on the screen.

• During full-width scanning, the Detector Carriage comes very close to the Limit Switches, so any imprecision will cause a Limit Switch to be tripped and the scan will be aborted with a Diagnostic Failure message for Transverse Motion Failure.

A cause of this problem is a loosening of the first drive Reduction Belt which connects the Transverse Motor to the first Reduction Pulley. This loosening causes the belt to "walk" on the pulleys causing enough imprecision in the motion to trip a switch. To tighten the belt, first remove the Pulley Shroud and loosen all four nuts that hold the motor in place. Then, while holding the motor such that the belt is pulled taught, tighten the nuts to secure the motor in place. Replace the shroud and test the scanner (an Alignment Test test works well).

If the Tube Head cables come into contact with the cable bundle entering the cable track, it may be impossible for the scanner to complete all of the necessary transverse steps away from the operator. Consequently, on each scan line the detector will move closer to the front transverse limit switch, and the switch may be eventually closed. Form the cable bundle exiting from the cable track into an arch such that the Tube Head cables will move under the arch rather than running into the bundle. This arch must not be too high. If it is, there will not be sufficient slack in the Tube Head cable bundle to allow the Tube Head to move to the front transverse limit switch. Also, if the arch is too small, it may cause too much slack when the Tube Head is at the forward side of the table. This causes the Tube Head cable bundle to rub against the inside of the front panel causing a scraping noise to be heard. If the above does not solve the problem then check the other mechanical components. Electrical components that could cause such a failure are the Centent Motor Controller, the Transverse Motor, the FOINK board or the SBC board.

4.11 Imaging Problems4.11.1 White, or Grey in the first or second scan line:

The software is not perfect in its ability to determine the correct grey level of the entire scan based on the first line of data. Sometimes the grey levels will be set incorrectly during acquisition. During analysis the grey level is easily adjusted to give a good image, and the results are not affected by this imaging problem. This problem is most often found on very thin patients. Adding extra tissue equivalent material (rice bag or saline solution) to a very thin patient may be all that is necessary to cure the symptom.

4.11.2 Femur Scan Problems

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Most image discontinuity problems occur in femur images performed at 3 mA on thin or osteoporotic subjects. These lines usually occur in the trochanter area where the x-ray beam is least attenuated by tissue.

These lines are caused by Automatic Gain Stabilizer (AGS) trying to adjust the input signal which is at an excessively high count rate. However, the AGS is not at fault, and the correct action is for the customer to attenuate the x-ray beam. Lunar normally recommends placing a rice bag (on its side to create 12 cm of patient thickness in the x-ray beam) along the side of the patient's thigh for thin or osteoporotic patients.

4.11.3 AP-Spine Image Problems: Probable causes• the shutter closes (causes the shutter open lamp to go out, and the End

of Exposure Alarm to sound).

• increase or reduction of high voltage to the detector (causes horizontal artifacts in the image).

• loss of the signal from the detector (this effects all 16 detectors at once)

• loss of current to the x-ray insert filament (28 volt power supply error message, the orange lamp to go out, and the End of Exposure Alarm to sound).

• bad x-ray relay contacts (providing power to tube head power supplies)

• reduction in AC Line voltage

• loss of proper high voltage on the x-ray tube

• faulty operation of the AGS system (white lines are short and found only where scan lines move from air into tissue).

• arcing (may cause vertical artifacts in the image)

4.11.4 Broken Signal CableThe cables which carry the voltage to the detector and return the signal from the detector array are part of the upper and lower cable bundle assemblies. Any break or significant pinch of the cable can cause reduction in counts in either or both channels. This could result in horizontal artifacts which effect all 16 detectors at once.

4.11.5 Loss of tube head currentThe tube head control cable contains the wires which provide power to the filament transformer. If the wire to the transformer center tap breaks, the x-rays will stop, the orange lamp will go off, and the end-of-exposure alarm will sound. If either of the other two wires break, the MAX board fuse will blow. Always ask the operator if a "ping" sound (the end of exposure alarm) is heard, and whether the Shutter Open or X-Ray On lamp turns off. In the case of a tube head current problem, the X-Ray On light will turn off.

4.11.6 X-Ray Relay Failure

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See section 4.16.

4.11.7 Unstable AC LineIf the customer's AC line conditions are unstable, voltages 11% below the scaners AC input configuration will begin to drop the high voltage on the x-ray tube. The counts will drop significantly with only a change of a few kV. However, this normally causes black or dark grey lines in the scan image.

4.11.8 ArcingIf the tube head is arcing, the arcs will be more likely to occur at the higher current settings. Arcing generally also causes other strange symptoms such as:

• Scanner stops in the middle of a patient or QA scan with no error message or with transverse mechanics fail

• The QA scan fails intermittently on bone chamber measurements

• The scanner periodically leaves the message on the screen "Starting X-rays Please Wait" for a longer than normal period of time (more than 10 seconds)

If you see arcing symptoms, try the following service action:

1.View the Quality Assurance History (see section 4.15). In particular note the trend in BM Values as discussed in the Failing QA's section of this chapter.

If there is evidence of failures in the mean BM value:

2.Repack the high voltage connections as described in the chapter 5 appendices. Note if an arc track is visible in the insulation compound.

3.Replacement of the tube head if no arc tracks are discovered, or if the repacking of the connectors does not eliminate all arcing symptoms.

Summary

Except for the x-ray relay, the cause of the problem will be difficult to find. Try to obtain some additional information. If the customer is hearing the end-of-exposure alarm, or seeing the yellow x-ray on lamp flickering, you can deduce the tube head control cable is bad. Likewise, it is possible to decide on the shutter/collimator/fan cable. In the case of no alarm or lamp indications, or in the case where large deviations occur in the peak, the upper and lower cable bundles should be replaced, as problems with the coaxial cable will be too expensive to troubleshoot.

4.12 Failing Alignment Test Results4.12.1 Image

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The Image is a graphic illustration of the counts recorded during the Alignment Test. A good image has a black field with evenly distributed grey dots and perhaps a few randomly distributed dots of various colors (green or blue usually).

Figure 4-6. Failing Ailigment Test

A poor Deviation Image will have lines, streaks or spots (indicating counts higher or lower than expected). When the image is analized, click first on points and then back to results, this will typically point type failing points (they will have a yellow box around them).

• The information tab (see figure 4-2) will show the test outcome (pass / fail).

• Lines or streaks going longitudinally in the image indicate an alignment problem. Recheck the alignment of the scanner including the levelness of the scanner. Also, check the scanner frame for any bending that may have occurred at the site or during shipment.

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• Lines or streaks going transversely across the Alignment Test image indicate a problem with the AGS, on the Detector Daughter Board in the detector array. Again, replace parts until a passing Alignment Test is obtained.

• Troubleshooting tip: if the Alignment test can be run with the Alignment Aperture on, this will make the test more sensitive as the beam will be further collimated to the exact size of the detector. Any failures (beam straying off the detector) will be exaggerated.

4.13 Indicator Failures4.13.1 X-ray On LED Blinking

The amber X-RAY ON LED should glow steadily once it is illuminated, until the x-rays are turned off. If the X-RAY ON LED blinks while the shutter is open for a patient scan, the End of Exposure Alarm should sound.

The amber LED is controlled by a comparator on the FOINK Board. This LED illuminates when approximately 40µA (or greater) of current is passing through the X-ray Insert. On Spellman system scanners the amber light may appear to fade out slowly when x-rays are ramped down. This due to the Spellman power supplies bleeding off current and is not a problem.

If the voltage ramping fails, the High Voltage Power Supplies must be shut completely off before a second ramping attempt is made. If the amber X-RAY ON LED turns on momentarily, then turns off for a few seconds before coming on steadily, the system is having difficulty ramping the high voltage. One of the High Voltage Power Supplies may be defective.

The SBC does not monitor the Insert current once the proper level has been reached. Therefore, if the current to the Insert is interrupted, the SBC will not recognize the problem and will not alert the computer, or terminate the exposure.

If the X-RAY ON LED blinks once the x-ray high voltage has been set, there must be a problem in one of the following areas:

• Tube Head Control Cable-The most likely cause of an intermittent problem in this circuit is a broken wire in the Tube Head Control Cable. The Red wire is most likely the broken one, as a broken blue or black wire should blow the MAX Board Fuse. Turn the scanner off and test for continuity between MAX Board test points TP4, TP5, and TP13.

• MAX Board-The MAX Board may be operating intermittently. Substitute a replacement MAX Board.

4.13.2 Shutter Open LED Blinking

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The amber Shutter Open LED is controlled by the Limit Switch on the Shutter/Collimator Assembly. If the Limit Switch is defective or improperly adjusted, the Shutter Open LED may be switched on and off. This will usually be accompanied by the sound of the End of Exposure Alarm if an exposure is underway.

If the Shutter is actually opening and closing intermittently and uncontrollably, the problem is either on the FOINK, or a broken wire between the FOINK and the Shutter/Collimator Assembly. Remove connector J11 from the FOINK Board and measure the resistance between pin 5 and pin 6. This will be a measurement of the resistance of the Shutter Solenoid and the cable through the Cable Track. If the problem occurs on every scan, run a scan while making this continuity check. If the cable and solenoid seem to be working properly, substitute a new FOINK Board.

4.13.3 Shutter Not OperatingIf the Shutter Solenoid will not open, the problem may be caused by one of the following:

• The Shutter Open LED-If the Shutter Open LED fails, a properly operating FOINK board will prevent operation of the Shutter Solenoid. Check the LED for continuity, replace it, or substitute a working amber LED temporarily.

• Solenoid Cable-Remove J11 from the FOINK Board and check continuity between pin 5 and 6 (see Shutter Open LED Blinking above).

• FOINK Board-Replace the FOINK Board.

4.13.4 End of Exposure Alarm During ScanIf the sharp "Ping" sound of the End of Exposure Alarm is heard during a scan, look at the computer display to see if a Diagnostic Failure Code is being reported. If so, see section 4.1.

If no Diagnostic Failure Code is reported, the scanner may still be in motion continuing with the scan. Abort the scan and remove the patient from the table. In any case, note the status of the SHUTTER OPEN light and the X-RAY ON light.

• Both the SHUTTER OPEN light and the X-RAY ON light are on and steady. This would indicate a faulty FOINK board. Replace it

The SHUTTER OPEN light is off. This could indicate the following:

• The LED becomes defective during the scan and since the shutter solenoid and this light are wired in series, the Shutter closed and the Alarm sounded.

• The cable to the amber Shutter Open light broke during the scan with the same result as above.

• The shutter solenoid failed and the Shutter closed followed by the Alarm sounding.

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• The FOINK is faulty.

• The SBC is faulty.

The X-RAY ON light is off. This could indicate the following:

• X-ray production has halted. This turns off the X-ray On light and sounds the Alarm.

4.14 Communications FailuresShould the scanner, host computer and or Detector Mother Board lose communications with each other, there are a number of things to check:

A good troubleshooting tool is the COMM test in Tools/Service Options - COMM tab.

Check

• the I/O cable connections at the serial port on the back of the Host computer and at the SBC. Be sure both connections are tight and that the thumb screws are used to hold the connectors firmly together.

• inspect the connector on the SBC. This connector is very fragile and may have been damaged. Be very careful when connecting the I/O cables to the SBC.

• Check and inspect the Signal Cable input at the SBC

• Check the Connection at the Detector Mother Board and the Bulkhead, where the two halves of the signal cable meet.

• Verify the power LED’s on the SBC are lit (See section 4.19)

• Verify that the Power LED’s and PLD programming LED’s are lit on the DMB (see section 4.21)

If the ports are properly configured and all power is present, and communication still fails, then the probable causes are:

• A faulty I/O cable.

• A faulty SBC.

• A faulty serial port / serial port card.

Replacement of these parts is the best troubleshooting method.

4.15 Viewing Quality Assurance Trends

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DPX-NT software includes the capability to view, print or graph data contained in the Quality Assurance database. View and print display selected results of many of the tests run during the Daily Quality Assurance in tabular form. The graph feature will graph the results of only one of the Quality Assurance parameters. All features allow for the user to select the time period to be examined.

4.15.1 What to Look for in the QA HistoryAll categories should remain steady over time. Check the PASSED column for failed QA’s. If a failing QA is found, try to determine the cause, including operator error.

The limit for % Spillover is 13%.

If any sudden jumps are noticed in the values of any of the categories, determine first if these are due to service work such as a Tube Head replacement. If service work causes a shift in the QA values, then compare present values to those obtained only after the service.

4.16 MAX Board TroubleshootingThe MAX board controls the current through the X-ray Insert in the Tube Head. DPX-NT scanners use MAX version 02B currently.

The current at a given kV across the insert is a function of insert filament temperature. The MAX board adjusts the current by regulating the filament temperature to provide the proper current as set by the SBC. The relationship is Insert µA X 1000 = SBC input (in volts DC), so for an SBC input of 5VDC, Insert µA = 5000.

The Positive High Voltage Power Supply has a current monitor output (mA MONITOR); the voltage at this output is proportional to the current passing through the X-ray Insert. This monitor voltage is connected to the MAX board as feedback (mA FEEDBACK).

What to look for

• Make sure that all connectors are fully seated.

• Check Lemo connectors for loose parts.

• Check for loose wires on the insulation displacement connectors.

• Check the position of the shorting jumpers on pin headers JB1, JB2, and JB3 for: Be sure pins 1 and 2 are connected as indicated by silk screen.

When the X-ray Relay is on, both the red and green LED's on the MAX board should be illuminated. If both are out, no power is getting to the MAX board. If only the red LED is lit, then the MAX board fuse is burned out or missing.

Electrical tests

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When the board is powered up, and x-rays are being generated, the following measurements may be performed:

With a VOM set on 200 VDC, you should measure about 18 to 21 VDC on TP's 4, 13 and 5 referenced to TP3 (GND).

Note: If an oscilloscope is available, you should see about 18 to 21 VDC on TP13. However, TP 4 & 5 should have a 36 to 42 volt peak square wave. A VOM will show the average value of the square wave, i.e. 18 to 21 VDC.

4.17 FOINK Board TroubleshootingThe FOINK is a multipurpose interface board designed for use with the DPX-NT. Operation is both analog and digital.

Optical isolation is used to isolate the +26VDC supply from the +5VDC and +12VDC (logic) supplies, and eliminate interference between the motor circuits and the event (detector) signals.

What to look for

Figure 4-7. FOINK Diagnostic LED’s

FOINK LED’s:

• A - (D10) Longitudinal OMI, when this LED flashes, the Longitudinal OMI infrared beam is

• B - (D9) Transverse OMI, when this LED flashes, the Longitudinal OMI infrared beam is

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• C- (D8) X-ray on (28 VDC supply), when this LED is lit when the +28 VDC power supply is on

• D - (D7) Mechanics engage, when LED is out the motor(s) are enabled

• E - (D6) - Errors Clear, must be lit - out when FOINK detects an error (failsafe)

• F - (D5) Reset when this LED is lit the SBC is in Reset

4.18 OMI Board TroubleshootingThe OMI board, being a rather uncomplicated device, has little in the way of things to watch for in installation and use. There are three such boards, one on the Front Longitudinal Carriage (transverse), at the foot of the scanner on the longitudinal idler shaft (longitudinal), and on the collimator (shutter open detect).

What to look for

• Check the connector to each board for proper seating.

• Examine the area where the wires attach to the board itself; it is possible the may fray or break.

• Insure that the interrupter disk does not rub against the plastic detector housing. If it does, adjust by loosening the two machine screws that attach the plastic detector, reposition the detector and re-tighten the screws.

Electrical tests

The signal from the OMI board is nominally rectangular in shape. The signal is generated when the Interrupter Disk alternately passes and occludes a light beam between the two posts on the photo-transducer. With the beam occluded by the disk, the output signal should be about 5 VDC (close counts). When the beam is allowed to pass through a slot in the disk, the signal output is near ground potential (see FOINK troubleshooting 4.17).

Symptoms of possible OMI failure

• Scanner shuts down at the beginning of a patient scan.

• Scanner shuts down unexpectedly during a scan.

• Either condition above should be accompanied by a Diagnostic Failure Transverse or Longitudinal (see section 4.0).

4.19 SBC Troubleshooting

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The SBC consists of a single circuit board that uses the 8032 microprocessor with a RS-422 interface to the Host PC and a RS-422 interface to the Detector Motherboard (DMB)

The SBC is located on the electronics pan in the front center.

Figure 4-8. DPX-NT SBC highlight indicates the location of the diagnostic LED’s

Figure 4-9. DPX-NT SBC Diagnostic LED’s

What to look for

• Green LED (C in figure 4-5) is on then you have +5VDC to the board.

• Red LED (A in figure 4-5) is on then you have +12VDC to the board.

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• Amber LED (B in figure 4-5) is on then you have -12VDC to the board.

• Red LED (E in figure 4-5) is the DTR reset line, when this LED is lit, the Detector, FOINK, or SBC are detecting an error.

When the DTR Reset Line is lit:

• Check the LED’s on the DMB (see section 4.21)

• Check the FOINK LED’s

• Check the Signal Cable

The Service Software can be used to verify communications between the Host / SBC and the DMB.

Go to Tools - Service Options - Communications Tab - test communications

• Red LED (D in figure 4-5) the scanner Reset, when this LED is lit, the communications with the Host PC are in Reset.

• Verify port settings on the Host PC (See DXPC 2000, chapter 5 Appendices)

• Verify communications cable

• Green LEDs (G and H in figure 4-5) flash when data is being received by the SBC

• Green LED (F in figure 4-5) is not assigned a function at this time.

The reset button near the communications cable connector causes a reset signal at the SBC microprocessor. Also, disconnecting the serial cable will cause a reset state until the cable is re-attached and communications reinstated.

4.20 XORB TroubleshootingThe XORB board routes a number of important signals to the rest of the system and protects the system from transients by shunting them to ground with transorbs.

What to look for

• All connectors firmly seated.

• Check to see that all wires and cables are firmly affixed to their respective connectors. Pay particular attention to Lemo connectors, since the jam nuts on the connectors are prone to be loose.

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• Check and tighten, if necessary, all mounting screws for the XORB board.

Electrical Tests

• Measure impedance between XORB ground plane and the electrical pan. It should be less than an ohm.

• There should be no low impedance (less than 10 ohms) reading between any signal or signal ground and chassis ground on the XORB when the as-associated signal connectors are disconnected.

The following test points should have the following readings:

4.21 Detector Motherboard Troubleshooting

Figure 4-10. DMB Diagnostic LED’s

Table 4-12. XORB Test Points

Test Point kV mA LimitsTP 1 76 .750 0.74 - 0.76TP 5 76 .750 0.74 - 0.76TP 1 76 3.00 2.97 - 3.03TP 5 76 3.00 2.97 - 3.03TP 2 76 .750 3.76 - 3.84TP 6 76 .750 3.76 - 3.84

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Diagnostic LED’s in figure 4-6

• A - (Green) Power +12 VDC Present

• B - (Green) Power - 12 VDC Present

• If the 12 VDC power LED’s are not illuminated power down the scanner, wait 30 seconds and power back up (see section Chapter 2.1.2)

• Check +5, +/-12 VDC Power Supply 1

• C - (Green) DMB PLD Programmed and ready

• If the DMB PLD LED is not lit verify FIRMWARE version with the Service Software (Tools/Set Download Parameters / Query), if necessary download to the DMB.

• D - (Green) DDB 1 PLD Programmed

• Verify the DDB card is seated in its socket

• E - (Green) DDB 2 PLD Programmed

• F - (Green) DDB 3 PLD Programmed

• G - (Green) DDB 4 PLD Programmed

• H - (Red) Data Sent to SBC (should flash when acquiring data)

• I - (Red) Data Sent to SBC (should flash when acquiring data)

• J - (Green) Detector Reset

• Verify Communications with the SBC

• Verify All DC voltages are Present on the DMB

• K - (Green) +5 VDC present

• Check +5, +/-12 VDC Power Supply 1

• L - Detector Mother Board Reset Button

4.22 Detector Daughter Board Troubleshooting

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Figure 4-11. Test Point Board

The Test point board gives the service engineer access to all of the signals for the individual Detector Daughter Boards

The Test Point Board is broken into 2 areas:

Analog Signals

DMB Controlled Programming Information (same data to all DDB PLD’s FIRMWARE from DMB Flash RAM)

• DCA REF - DCA Reference Levels - High and Low Energy Reference Levels for event counting windows

LEL = 1.19 VDC

LEH = 1.66 VDC

HEL = 1.96 VDC

HEH = 2.79 VDC

• AGS REF AGS Reference Levels - High and low Energy

CENTER = 2.35 VDC

LOWER = 2.00 VDC

• Detector Bias Setting (BIAS =.450VDC)

• +5 VDC Ref (+5.00 VDC)

• - 5 VDC Ref (-5.00 VDC)

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Individual Detector Signals (Stored in DMB Flash RAM)

• GAIN - combination of Peak and AGS signal gain - setting for Shaping Amplifier - visible only with Oscilloscope

• AGS - AGS amplify or Attenuate signal - visible only with Oscilloscope

• BiPolar - Bipolar signal out of the shaping Amplifier

Digital Signals

• AGS ROLL - logic signal for AGS rollover - this signal is not currently utilized by the software

• LE - Low Energy Event detected and counted

• HE - High Energy Event detected and counted

• SAMPLE - Sample clock signal

• AGS ENABLE - Operate Calibrate signal - locks out AGS for Peaking operation

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5 111Service Procedures

Chapter 1:Service Procedures This chapter contains procedures for testing and replacing parts.

The appendices are all uncontrolled copies of GMP documents and as such are subject to change without notice.

5.0 Reloading LUNAR Software . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-1555.1 Peaking the Detector . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-155

5.1.1 Peaking Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-1555.2 Tube Head Replacement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-156

5.2.1 Shelf Life . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-1575.2.2 Mounting The Tube Head . . . . . . . . . . . . . . . . . . . . . . . . 5-157

5.3 Lower Cable Bundle Replacement . . . . . . . . . . . . . . . . . . . . . . . . . 5-1575.3.1 Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-157

5.4 Upper Cable Bundle Replacement . . . . . . . . . . . . . . . . . . . . . . . . . 5-1605.4.1 Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-160

5.5 Tube Head Control Cable Replacement. . . . . . . . . . . . . . . . . . . . . 5-1625.5.1 Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-162

5.6 Tests to Perform after Service . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-1655.7 Returning Parts To LUNAR (For International Distributors) . . . . . . 5-166

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5.0 Reloading LUNAR SoftwareIt is sometimes recommended in answer to a particular problem that the software be reloaded. This can be accomplished by locating the latest version of the Lunar Software. Please note, it may also be necessary to have the customers system ID number and feature code.

Note: BE SURE OF WHICH VERSION OF SOFTWARE IS PRESENTLY BEING USED! RELOADING OLDER SOFTWARE CAN DESTROY IMPORTANT DATA.

• The about tab under the help menu of the Lunar Prodigy Software shows which version is presently on the system.

• Insert the Lunar System CDROM into the CDROM: drive

• Double click on the My Computer icon on the Windows NT desktop

• Double click on the CD ROM Drive with the LUNAR Prodigy CDROM in the drive

• Double click the Software Installation ICON

• Follow the instructions on the screen until a message is displayed confirming a successful software load.

Note: When new versions of software are released they may not be loaded in the above manner. BE SURE TO FOLLOW THE LOADING INSTRUCTIONS THAT ACCOMPANY ALL SOFTWARE UPDATES.

5.1 Peaking the DetectorThe Prodigy Detector may need to be repeaked, this is a good diagnostic tool to use when a detector is suspect.

The actual peak setting of each of the detector elements is done in the software - on the Detector Mother Board with the data from the Detector Daughter Board.

5.1.1 Peaking Procedure1) Go to the Service Mode of the Prodigy Software, open the Spectrum Option (Tools/Spectrum)

2) Place the brass spillover piece on top of the collimator aperture.

3) Click on the Peak button in the Prodigy Software toolbar.

4) Verify that all values are 2000 +/- 600.

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5.2 Tube Head ReplacementWhen a replacement Tube Head is sent to a site in the field for replacement, it is not ready for immediate installation into the scanner. Some parts from the old Tube Head must be transferred to the new Tube Head (see list below and figure 5-1).

These parts are: 1) tilt bar

2) lead ring (around filter area)

3) lead wrap

4) fan bracket

5) nuts, bolts and washers

6) collimator positioning hardware

7) the collimator assembly.

Figure 5-12. DPX Series Tube Head components

Verify that all necessary parts have been transferred to the new Tube Head before shipping the defective. LUNAR has received defectives with the lead ring, for example, still in them.

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5.2.1 Shelf LifeMany distributors have asked about the shelf life on the Tube Heads in their stock. The shelf life of the Tube Head is not accurately known, but we feel at this time that it is over two years. Perform the following Tube Head inspections on all replacements before mounting them:

1.Check the shelf for oil spots which would indicate that the Tube Head has a leak. If oil is discovered, return the Tube Head for warranty replacement.

2.Shake the Tube Head and listen for the sound of an air pocket or bubble inside. If a bubble is discovered, return the Tube Head for warranty replacement.

Note: If a Tube Head has been on the shelf for three weeks or more, perform the warm up procedure described in Procedure DXAP2001 Prodigy Source Detector Alignment.

5.2.2 Mounting The Tube HeadUse procedure DXSE0000 in this chapter's appendix for repacking the new Tube Head's high voltage connections, and refer to the installation procedures, DXAP2001 and DXAP2002 (also in this chapter's appendix), for tube head mounting and alignment procedures.

5.3 Lower Cable Bundle ReplacementNecessary tools:

• 1/8" and 5/32" Hex Wrench,

• Small Screwdriver

• Diagonal Cutters

• 3/8" Wrench

• Large and small wire ties.

5.3.1 Procedure1.Shut off the power to the scanner.

2.Take off the table top by removing four screws (two at each end).

3.Remove the head and foot end panels. At the foot end of the scan table unplug the A/C power cable to the scanner.

4.Move the scan arm to the head end of the table.

5. On your new lower cable bundle, use a diagonal cutters to cut the wire ties holding the cable together, also unfold and read the LUNAR SERVICE NOTES attached to the new cable bundle.

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6.Lay the new cable bundle flat out on the floor. Locate the end with the (2) 16 pin connectors and the yellow and orange Lemo connectors, this is the end that connects to the bulkhead, this is the end to start the install action from.

7.Locate the bulkhead on the scanner. There are (3) wire ties that hold the cable bundle in place between the bulkhead and the cable track. Before cutting any wire ties note the way the cable bundle is tied down and the way the cable lays before it enters the cable track. The new cable must be fastened in the same position and lay the same way.

8.Carefully cut the (3) wire ties between the bulkhead and the cable track with your diagonal cutters. Disconnect the large RS232 connector (Detector Signal Cable) by unscrewing the two screws on the connector.

9.Next disconnect the two white 16 pin molex connectors. These connectors have a catch lock located in the center of the housing which must be depressed to disconnect them from the bulkhead.

10.If you try to remove the cable bundle by pulling it back towards the cable track you will notice a 3 conductor gray wire cable tied to the high voltage cable bundle. This wire carries the transverse optical interrupt signal from the front carriage (we will refer to this wire as the OMI cable). To find the location of the OMI board and the front carriage follow the OMI cable. On your new Cable bundle the OMI wire is connected through the bulkhead.

11.To remove the OMI cable push the x-ray tube head all the way to the outside of the scanner (patients left side), then notice the clearance between the front panel and the high voltage cable bundle connecting to the x-ray tube head and the way the cables are tied down as you will need to wire tie them back the same way.

12.Now you can cut the (4) large wire ties and the (2) small wire ties that hold down the high voltage cable bundle and OMI cable. Then you can pull the lower cable bundle back to where it enters the cable track.

13.Next take your small screw driver and pry open (20) of the cable track plastic retaining clips that hold the cables into the track. These clips pivot at the back of the cable track and can either be removed or left in the open position so the cables can be removed.

14.Pull the old cable bundle out of the cable track towards the foot end of the table.

15.Now install the (3) conductor OMI cable from the bulkhead to the OMI BOARD. To do this you must remove the white 16 pin connector from the bulkhead labeled bulkhead 2, this connector is a part of the upper cable bundle and the new OMI cable will connect into this housing. Note the position of the wire tie that holds the upper cable bundle in place and then cut it in order to pull the connector out to install the OMI cable. Note the orientation of the existing terminals in this bulkhead connector as they slide and lock into the connector in one direction only. Where the wires enter the connector each hole is numerically labeled. Put the green wire into hole # 11, and the black wire into hole # 9, and the red wire into hole # 1.

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16.Slide the connector back into the bulkhead bracket the way it came out and fasten the upper cable bundle with a large wire tie the way it was before the original wire tie was cut.

17.Route the new OMI cable in the same position as the previous cable and connect it to the OMI board. Then tie the high voltage cable bundle and the OMI cable down to the high voltage cable trough,(there are three large wire ties near the bulkhead, two large wire ties put together to tie the high voltage cables down at the center of the high voltage cable trough, and two small wire ties to anchor the OMI cable down to the Bracket before it connects to the OMI board). Before tightening the wire ties assure that the proper clearances and no stress is applied at any of the connectors or wires. Tighten the center cable ties first (two large wire ties put together and located at the center of the high voltage cable trough). Be sure the high voltage cable bundle does not hit the front panel when the tube head is all the way toward the outside of the scanner (patients left). Then tighten the three wire ties near the bulkhead making sure that the high voltage cables do not hang over into the cut out space on the high voltage cable trough as they may hit the longitudinal motor bracket and cause positioning problems.

18.Take the new cable bundle and connect it to the bulkhead by routing the cable bundle the same way as the replace cable bundle, (note the connectors are labeled bulkhead 1 and bulkhead 2) and fasten the cable bundle down in the three spots between the cable track and the bulkhead with wire ties. Lay the new bundle down into the cable track making sure all the cables lay parallel to each other. Start replacing the clips to the cable track as far as you can. Continue the process: remove a few clips, extract the old cable bundle, add in the new cable bundle, and replace the clips.

19.To finish removing the old and installing the new cable bundle in the lower portion of the cable track you must remove a screw located at the end of the cable track. To do this use a 1/8" hex wrench and a 3/8" wrench. Once you remove the screw you can lift the cable track out of the channel it rides in and finish prying open the remaining clips. Remove the old cable bundle until it reaches the cable entrance hole, where all the cables enter the electrical pan area. Then finish installing the new cable bundle until you reach the cable entrance hole, finish clipping all the clips and then replace the cable track hold down screw (do not tighten the screw at this time).

20.Locate where all the wires from the old cable bundle terminate on the electronics pan. All of the wires are labeled except for the wires that go to the terminal block. Here is a list of wires that must be disconnected before removing the cable bundle from the pan area. SBC(J-5), FOINK(J-17), FOINK(J-12), FOINK(J-14), FOINK(J-5), FOINK(J-8), PMT/AGS(J-11)(J-11 is the yellow Lemo connector), the orange Lemo connector (connected to the H.V. Lemo box), then the last three wires connect to the Terminal block. Write down the number where the orange, blue and yellow wires go to on the terminal block and disconnect them with your small screwdriver. Carefully pull the old cable bundle through the cable entrance hole from the pan area. The old cable bundle may now be discarded.

21.Carefully feed (one connector at a time) the new cable bundle wires through the cable entrance hole into the pan area. Connect the wires to their proper locations.

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22.Then move the arm all the way down to the foot end of the scan table. At this time make sure that the Lower cable bundle and the high voltage cable bundle have some slack where the cables enter the cable track near the bulkhead area. Then make sure the cable track has at least 1/8" of clearance from hitting the frame. To adjust this slide the cable track in the trough it rides in to get the proper clearance, then tighten the screw that holds the cable track in place with a 1/8" hex wrench and a 3/8" wrench. Move the arm up and down the scan table to be sure there is nothing wrong with the cable track motion. Leave the arm at the foot end of the table.

23.Leave a little slack in the cables from the cable track to the pan area to allow all of the cables to be routed and wire tied exactly like the original cables.

24.Reconnect the A/C power cord, put the table top, pad, and end panels back on the scanner.

25.Turn on the scan table, computer, monitor and printer. Perform required tests per section 6.9 of the Prodigy Service Manual.

5.4 Upper Cable Bundle ReplacementTools Necessary:

• Small Phillips Screwdriver

• Small Slot Screwdriver

• Diagonal Cutters

• Hex Wrench Set

• Mini Molex Pin Extractor

• Large and Small Wire Ties.

5.4.1 Procedure1. Turn off the power to the scan table.

2. Remove the table top by removing the two screws at each end.

3. Remove the front panel of the scan table

4. Lastly, remove the column cover of the arm held in place by screws.

5. Remove the upper and lower arm covers by removing the (8) screws that hold it in place.

6.Open the cable track and cut the wire ties at the end of it. Disconnect all the cables coming from the cable track and remove the cable bundle as far as the top of the column (through the hole).

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7.Place the new cable bundle in the cable track and connect all cables to their appropriate positions. Close the cable track and wire tie the cables at the end of it. Route the cable bundle through the hole in the top of the column.

8.Next locate the Laser On light and disconnect it. Remove this cable to the top of the column cutting any necessary wire ties.

9.Route the new cable to the Laser On light and connect. Replace any wire ties removed in step 5.

10.From the back of the arm column follow the cables vertically down and cut all the wire ties holding the upper cable bundle to the other cable assemblies.

11.Carefully pull the upper cable bundle out towards the back of the arm and down through the holes in the column.

12.Next cut the wire ties that hold the cables down near the bulkhead, these are located in the lower rear portion of the arm.

13.Make sure the bulkhead connectors are labeled on both sides of the bulkhead bracket and then disconnect them.

14.Next remove the two (16) pin Molex housing connectors that are attached to the upper cable assemblies from the bulkhead bracket. Also disconnect the large RS 232 connector from the bulkhead bracket. Pull the housings and the Signal cable connectors out to work on them.

15.Use the mini Molex pin extractor tool and remove from bulkhead 1 pin16 and pin8. From bulkhead 2 (the lower connector) remove pin15, pin16, pin6, pin7, and pin8.

16.Now remove the old cable bundle by pulling the cable out through the back of the column. The old cable may now be discarded.

17.Next route the new cable bundle through the column wire tieing as you go.

18.Route the taped end of the cable through the hole at the bottom of the column to the bulkhead area (follow the other cables that go to the bulkhead).

19.Carefully remove the masking tape from the cable exposing the mini Molex pins and the Lemo connector. Note the orientation of the existing terminals in the bulkhead connectors and the numeric labels at each hole of the connector.

20.Replace the wires one at a time removing the wires from the old cable and replace them with the wires from the new cable.

21.Insert the connectors into the bulkhead bracket the same way they were removed and fasten the upper cable bundle with wire ties as original.

22.From the wire tie just fastened, the cables going into the arm column must not have any slack in the cables (pull the cables from the column area to remove any slack). Make sure that none of the cables hit any of the moving parts in the narrow area where the cables come from the back of the column out to the bulkhead.

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23.Mount the column cover back in place and replace the top and bottom arm covers. Replace the table top, table pad and the head and foot end panels back on to the scanner.

24.Turn on the power to the scan table. Run Required tests as prescribed in section 6.9 of the Prodigy service manual.

5.5 Tube Head Control Cable ReplacementRequired Tools:

5.5.1 Procedure1.Switch off the power to the scanner.

2. Remove the tabletop, head and foot end panels. At the foot end of the scan table unplug the A/C power plug to the scanner.

3.Move the scan arm to the head end of the table.

4.Take the black tape off the high voltage cable bundle at each end of the sleeving (open any cable track clips that are in the way as in step 8) as well as any wire ties holding the bundle in place. Next, slide the sleeving away from the tube head and remove the tape beneath the sleeving. Note the positions of each cable before removing the tape. The cables must be returned to these positions.

5.Disconnect the military-style connector and the ground wire (if one exists) from the tube head and slide the cable out of the black sleeving toward the cable track.

6.Unplug J3 and J5 on the XORB board. Also, trace the ground wire (if one exists) from the control cable and disconnect it from the power supply. Cut the wire ties holding the control cable to the pan.

7.Pry open the plastic retaining clips that hold the cables into the cable track. These clips pivot at the back of the cable track and can either be removed or left in the open position to remove the cables. The screw located at the end of the cable track near the pan must also be removed. Once this screw is removed the cable track can be lifted out of the channel it rides in and the remaining clips can be opened. Mark the position of the cable track screw on the frame to return the track to its original position.

8.Remove the old control cable. Note the position of all the cables in the cable track. They will need to be returned to the same position during this procedure.

If the cables are not returned to their original positions, cable damage will result.

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9.Feed the new cable, military connector first, through the black sleeving on the high voltage cable bundle starting near the bulkhead. The sleeving can be expanded by pushing two parts of it together to better fit the connector through.

10.Once the cable is through the sleeving, connect it to the tube head and connect the ground wire (see figures 1 and 2). Position the cables next to the high voltage cable bracket as in figure 1. The collimator control cable should come out of the cable bundle between the two high voltage cables toward the back of the scanner. Tape the cables together for several inches with three layers of electrical tape starting as close to the bracket as possible. Continue to spiral the tape around the cables as it was originally and finish by taping three layers for several inches near the bulkhead. Tape the sleeving near the bulkhead as it was originally. Pull the sleeving tight along the bundle and tape near the tube head. Wire tie the cables to the tube head high voltage cable bracket.

Figure 5-13. Profile Cable Routing Diagram

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Figure 5-14. Top Down Cable Routing Diagram

11.Lay the control cable in the cable track in the same position as the original one. Start replacing wire ties between the bulkhead and the tube head. Before tightening the wire ties assure that there is proper clearance and no stress is applied at any of the connectors or wires through the entire range of motion. Tighten the center cable ties first (two large wire ties put together and located at the center of the high voltage cable trough). Be sure the high voltage cable bundle does not hit the front panel when the tube head is all the way toward the front of the scanner. Make sure the high voltage cables do not hang into the cut out space on the high voltage cable trough. Tighten the three wire ties near the bulkhead.

12.Replace the clips to the cable track and reattach the track to the scanner frame.

13.Move the arm to the foot end of the scan table. Check that the lower cable bundle and the high voltage cable bundle have some slack where the cables enter the cable track near the bulkhead. Check that the cable track has at least 1/8" clearance of the frame. To adjust this, slide the track in its trough, then tighten the screw that holds the track in place. Move the arm up and down the table to verify that the cable track moves properly.

14.Reconnect the A/C power cord, and replace the table top and end panels.

15.Perform required tests as prescribed in section 6.9 of the Prodigy Service Manual.

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5.6 Tests to Perform after ServiceTable 5-13. Tests to Be Performed after Service

Part Replaced or Procedure Performed

Primary Calibration

Secondary Calibration /

QA

Phantom Scans

Alignment Test

+5, +/- 12 VDC Power Supply - 1 - -

26 VDC Power Sup-ply - 1 - -

28 VDC Power Sup-ply - 1 - -

Detector Mother Board or Daughter

Board1 5 3 1

Detector 1 5 3 1

Centent - 5 3 1

Collimator - 5 3 -

Laser - 1 3 -

Lower Cable Bundle - 5 3 1

MAX, FOINK, or XORB Board - 5 3 1

Motor, Belt, Pulley or Gears - 5 3 1

High Voltage Power Supply 1 5 3 1

Tube Head 1 5 3 1

SBC - 5 3 1

Tube Head Control Cable - 5 3 1

Upper Cable Bundle - 5 3 1

System Move or Installation 1 10 3 1

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5.7 Returning Parts To LUNAR (For International Distributors)

Return parts prepaid to Lunar. Please list our customs broker as intermediate consignee:

Burlington Air Express

6023 S. Howell Ave.

Milwaukee, WI 53237-0140

Shipments of defective parts being returned to LUNAR from international distributors should add the following instructions to the air bill and proforma invoice:

DEFECTIVE EXCHANGE SERVICE PART, RETURN TO VENDOR.

NO DUTIES SHOULD APPLY. ALL PARTS ARE MANUFACTURED IN THE UNITED STATES. FOR CUSTOMS CLEARANCE PLEASE NOTIFY THE BURLINGTON AIR EXPRESS IMPORT DEPARTMENT:

BURLINGTON AIR EXPRESS IMPORT DEPARTMENT

PHONE:414-482-0700

FAX:414-482-0965

WATS:800-242-3821

Note: All parts must have a completed RMA tag with them. Necessary information includes: which system they are from, and the symptoms each part exhibited in failure should be described.

NO WARRANTY OR EXCHANGE CREDITS WILL BE GIVEN UNTIL THESE CONDITIONS ARE MET!

Parts must also be returned within 90 days of LUNAR opening a service report for them (usually the day they are shipped). All parts not returned within 90 days (warranty or not) will be invoiced for at the distributor price.

Note: If it is the intention of a distributor to keep a part for their spare parts stock, they should notify the LUNAR Customer Service Department. This way, LUNAR may immediately invoice for such parts and close service reports in a more timely manner.

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QUALITY SYSTEM DOCUMENT Page 1 of 26 It is the responsibility of the user to verify this document originated from the controlled master and is the active revision prior to use. This document contains confidential or proprietary information of GE Lunar. Neither the document nor the information therein is to be reproduced, distributed, used or disclosed, either in whole or in part, except as specifically authorized by GE Lunar.

DOC. ID: DXSE3004 REVISION: A DATE: 03/06/03 WRITTEN BY: Jeff Allen

MANUFACTURING PROCEDURES

GE Medical SystemsLUNAR

g

APPROVED ON CO: L10597

TITLE: Encore Computer Swap Procedure

PURPOSE This document provides instructions for replacing and transferring customer data for Encore computers.

APPLICATION This document applies toward Encore computers.

SAFETY PRECAUTIONS None.

ASSOCIATED MATERIALS None.

DEFINITIONS None.

PROCEDURES

1. Computer Swap - Preparation. The service engineer should contact the customer and determine the following information:

a. Determine the required software version. i. Billable customers

1. Bill to upgrade to newest version. 2. No charge and use their current version.

ii. Contract/Warranty 1. A customer in a research study may require a specific

version of software. 2. Would upgrade to the latest available software version

b. Determine the required printer drivers. i. Ask the customer what kind of printer they are currently using.

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GE Medical Systems LUNAR

DOC ID: DXSE3004

REV: A DATE: 03/06/03 CO: L10597

QUALITY SYSTEM DOCUMENT Page 2 of 26 It is the responsibility of the user to verify this document originated from the controlled master and is the active revision prior to use. This document contains confidential or proprietary information of GE Lunar. Neither the document nor the information therein is to be reproduced, distributed, used or disclosed, either in whole or in part, except as specifically authorized by GE Lunar.

c. Determine the required archive media.

STARTComputer Uses Ls120 or

Zip250?

Zip250

Ls120

Billible?

More than 10disks to convert? No

Will customer pay formedia conversion?

No

Yes

Yes

Order a computerwith a Zip250 drive

Order a computerwith a LS120

No

2. Computer Swap - Order Material

a. If the customer does not have required Encore software on site, then order the customer’s current software version or the latest revision as required.

i. This is ordered from Kevin Jones in the software department. Make sure to fill out a shipping form with pertinent information (system ID, version number, shipping address, and date/time needed), and email it to Kevin.

ii. As a side note, there could be a charge for replacement or upgrade software. Contract and Warranty customers do not pay software replacement or upgrade fees (an upgrade would be anything up to 6.7). Billable customers must pay a $390.00 replacement fee (Rcat number RF209YJ) or a $1200.00 upgrade fee (Rcat number RF209SB).

b. Order the appropriate printer drivers if necessary. i. If the computer that will be installed is Windows XP, then no driver

CD is required. Computers with the Windows NT operating system and an HP940c or 930c, will require the HP 4.3 CD. The 4.3 HP

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GE Medical Systems LUNAR

DOC ID: DXSE3004

REV: A DATE: 03/06/03 CO: L10597

QUALITY SYSTEM DOCUMENT Page 3 of 26 It is the responsibility of the user to verify this document originated from the controlled master and is the active revision prior to use. This document contains confidential or proprietary information of GE Lunar. Neither the document nor the information therein is to be reproduced, distributed, used or disclosed, either in whole or in part, except as specifically authorized by GE Lunar.

driver version is made specifically for the HP930c printer. This driver will work with the HP940c printer as well. In fact, there are problems with the HP940c printer driver. This is why the 4.3 printer driver is used for the HP940c printer. This can be ordered the same way software is from Kevin Jones.

c. Order the appropriate computer via GPO.

i. Below is a list of current computer part numbers. Never order a computer part number that is older than part number being replaced.

d. e.

3. Computer Swap – Procedure

a. Unpack new computer. b. Connect monitor, mouse and keyboard to new computer. c. Power on computer. d. Remove current printer driver.

i. In Windows XP highlight and delete the printer driver. 1. Click on Start/Printers and Faxes. 2. Highlight the installed printer driver.

NT Computers Description LNR8627 Omnitech 500 MHz W/ LS-120 LNR40004 Omnitech 566MHz w/ LS-120 LNR40227 Omnitech 677MHz w/ LS-120 LNR40315 Omnitech 776MHz w/ Zip 250 LNR40324 Omnitech 766MHz w/ Zip250 LNR40591 Omnitech 900MHz w/ Zip 250

LNR40739 OT 1.2 GHz, 512 Meg RAM, 40 Gig HD,

ZIP250

MD+ Computers Descrption LNR40010 Omnitech 566MHz w/ LS-120 LNR40229 Omnitech 677MHz w/ LS-120 LNR40317 Omnitech 667Mhz w/ Zip 250 LNR40326 Omnitech 766MHz w/ Zip250 LNR40593 Omnitech 900MHz w/ Zip 250

LNR40741 OT 1.2 GHz, 512 Meg RAM, 40 Gig HD,

ZIP250

Prodigy Comp Description LNR8683 Omnitech 500 MHz w/ LS120 LNR40228 Omnitech 677MHz w/ LS-120 LNR40316 Omnitech 776MHz w/ Zip 250 LNR40325 Omnitech 766MHz w/ Zip250 LNR40592 Omnitech 900MHz w/ Zip 250

LNR40740 OT 1.2 GHz, 512 Meg RAM, 40 Gig HD,

ZIP250

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GE Medical Systems LUNAR

DOC ID: DXSE3004

REV: A DATE: 03/06/03 CO: L10597

QUALITY SYSTEM DOCUMENT Page 4 of 26 It is the responsibility of the user to verify this document originated from the controlled master and is the active revision prior to use. This document contains confidential or proprietary information of GE Lunar. Neither the document nor the information therein is to be reproduced, distributed, used or disclosed, either in whole or in part, except as specifically authorized by GE Lunar.

3. Press the <Delete> key. 4. The computer will ask, “Are you sure you want to delete the

printer?”. Click YES. 5. A message will appear, “Warning: The default printer has

been deleted.” Click OK. ii. In Windows NT you need to use the HP uninstall feature. This is

found by clicking on Start/Programs/Hewlett-Packard/HP Deskjet xxx series/uninstall. The prompt may vary slightly printer to printer. Follow the on screen prompts to uninstall the printer. If it makes you restart the computer you can skip to step 6.

e. Power off computer and connect printer. f. Power on computer and load appropriate printer driver. If using Windows

XP, the printer driver will load on its own. g. Enter Encore software and check current software version loaded, system

ID and feature code. Click on: Help/About at the top of the screen to see this information. *See figure 1 and 2.

Fig. 1

Fig. 2

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GE Medical Systems LUNAR

DOC ID: DXSE3004

REV: A DATE: 03/06/03 CO: L10597

QUALITY SYSTEM DOCUMENT Page 5 of 26 It is the responsibility of the user to verify this document originated from the controlled master and is the active revision prior to use. This document contains confidential or proprietary information of GE Lunar. Neither the document nor the information therein is to be reproduced, distributed, used or disclosed, either in whole or in part, except as specifically authorized by GE Lunar.

If the System ID and/or the feature code are incorrect, click on: Tools/User Options/Systems Tab to change them. *See figure 3 Fig. 3

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If the software version loaded is older than required, then load the correct version. If it is too new, then it must be removed from the system and the correct version must be loaded. Do the following to load older software:

i. Exit Encore. ii. Go to the Control Panel and click Add/remove programs. iii. Highlight the appropriate Lunar Program (Prodigy, DpxNT or

DpxMD), and click REMOVE. iv. In Windows Explorer, delete the C:\Program Files\Lunar or

D:\Program Files\Lunar depending where it was loaded. v. Delete any directories called C:\Data or D:\data. vi. Load the appropriate version of Encore software. vii. When loading make sure to enter the customer’s System ID and

Feature Code. h. Verify QA Block Batch Number

The batch number in the Encore software must match, the number on the QA block. The batch number can be found in Service Options, on the lower right hand corner of the Calibration tab. It will either be bath 1 or batch 2. If this number does not match the one on the QA block then change it appropriately and press Select Batch. Click OK.

i. Database Transfer **At this point the procedure will vary depending on whether or not archive media conversion is being performed or not. If the old and new computers both use the same archive media then use procedure A. If converting from LS120 to Zip250 use procedure B.

i. Procedure A: New Computer Uses the Same Archive Media As Old Computer

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1. Enter Encore software. 2. Go to the Directory Screen. 3. Create a database for each database being transferred to

the new computer, by clicking on New Database, on the left hand side of the screen.

*See figure 4 for an example of the New Database window. a. Name – This will normally be “Patients”, by default. b. Working Drive - If the new computer has Windows

XP, then the Working Drive, should be D. If Windows NT, then it should be C.

c. Working Directory - Use Windows Explorer to examine the last archive disk for the database in question. Double click on the last archive disk. There should be an Archive folder. Double click on the Archive folder to see what folder is located in it. The working directory should match this folder name. Always make sure their main database is done first.

d. Allow Archive/Restore from this workstation – This would normally be checked.

e. Archive Drive - will be set to what the drive letter for the Zip or LS120 drive is in Windows Explorer. This is usually A for LS120 ands E for Zip drive.

f. Days between Backup Prompt – The default value for this is “7”.

g. Click OK, and the New Database window will disappear.

Fig. 4

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4. Click on Edit Database. An Edit Database window will appear.

a. Set Archive Number to whatever the customer’s last disk number was for that database.

b. Click OK. The Edit Database window will disappear. *See figure 5 for an example of the Edit Database window.

Fig. 5

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5. Now the customer’s main database can be restored onto the new computer. To do this, click on Directory at the top of the screen. A drop down menu will appear. Choose Database Utilities and Restore Backup. *See figure 6

Fig. 6

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a. A Restore Backup window will appear. Insert the customer’s current archive disk. *See figure 7

Fig. 7

b. There is a file on the Archive disk called “ProdigyBackup.zip”. This file must be browsed to, by clicking on the Browse button. A Browse for Folder window will appear. *See figure 8

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Fig. 8

c. ProdigyBackup.zip is usually located in

A:\Archive\Data. If it is a Zip disk, then it will probably be E:\Archive\Data. The Data portion of the path must match the working path of the directory. If the archive disk is for a database with a working path of Data2, then it will be Data2 rather than Data.

d. Click OK. The Browse for Folder window will disappear, revealing the Restore Backup window again.

e. Under the Backup File Contents section, a list of files will appear. Click the Select All button. All of the files will become highlighted. . Only click Select All, when restoring the customer’s main database. If restoring a different database, then just highlight the Lunar.mdb file. Click OK. *See figure 9

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Fig. 9

6. A warning message will appear. Click OK. *See figure 10 Fig. 10

7. A status bar will appear in the lower left hand corner of the

Directory screen. Once it reaches 100%, a window should appear stating, “Backup files have been successfully restored”. Click OK. *See figure 11

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Fig. 11

The patient database and all the calibration information should now be on the new computer. 8. ****If the Restore backup procedure does not work, then repeat

the Restore procedure. If it still does not work, then call Customer support for help.

9. After the Restore Backup procedure is completed successfully, perform a database rebuild from the last archive disk. Insert the last archive disk. This is done in case the last time they archived they did not perform an Archive All.

10. Click Rebuild Database. Make sure “Working Directory” is selected under Source Options. *See figure 12

Fig. 12

11. The Exam List on the left hand side of the window should show all the scans that are stored on the archive disk. Click Select All. All of the scans will highlight indicating they are selected.

12. Click OK. The rebuild process will begin indicated by a status bar at the bottom.

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13. When finished a window will appear, Rebuild session completed successfully. Click OK. This window will disappear and the rebuild session will be complete. *See figure 13

Fig. 13

ii. Procedure B: New Computer Uses Different Archive Media Than Old Computer

1. Shut the computer down. 2. Disconnect the power cable to the new computer. 3. Open the computer case of the old computer. 4. Disconnect and remove the LS120 drive from the old

computer. 5. Open the computer case of the new computer. 6. Disconnect the IDE cable from the Zip 250 drive. 7. Disconnect the floppy cable from the motherboard. 8. Disconnect the power cable from the floppy drive. 9. Connect the Zip 250’s IDE cable to the LS120 drive. 10. Connect the floppy drive’s power cable to the LS120. 11. Boot the computer. 12. Press <F2> to go into the BIOS Setup screen as the

computer is booting up. Not all computers will use F2 to enter BIOS Setup.

13. In the BIOS Setup, disable the floppy controller. How this is done will vary depending on the BIOS that is on the computer in question.

14. Save the changes and exit. 15. Let the computer boot into Windows. 16. Run Windows Explorer, and verify the LS120 drive is being

recognized as the A: drive. Try to read an LS120 disk to verify this.

17. Enter Encore software. 18. Go to the Directory Screen. 19. Create a database for each database being transferred to

the new computer, by clicking on New Database, on the left hand side of the screen. A New Database window will appear. *See figure 14

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Fig. 14

If the new computer has Windows XP, then the Working Drive, should be D. If Windows NT, then it should be C. You can tell what the Working Directory should be, by using Windows Explorer to examine the last archive disk for the database in question. Always make sure their main database is done first. The Archive Drive will be set to A. Click OK, and the New Database window will disappear. 20. Click on Edit Database. An Edit Database window will

appear. *See figure 15

Fig. 15

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21. Now the customer’s main database can be restored onto the

new computer. To do this, click on Directory at the top of the screen. A drop down menu will appear. Choose Database Utilities and Restore Backup. *See figure 16

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Fig. 16

22. A Restore Backup window will appear. Insert the customer’s first archive disk. *See figure 17

Fig. 17

23. There is a file on the Archive disk called “ProdigyBackup.zip”. This file must be browsed to, by clicking on the Browse button. A Browse for Folder window will appear. *See figure 18

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Fig. 18

The ProdigyBackup.zip will be located in A:\Archive\Data. The Data portion of the path must match the working path of the directory. If the archive disk is for a database with a working path of Data2, then it will be Data2 rather than Data. 24. Click OK. The Browse for Folder window will disappear,

revealing the Restore Backup window again. 25. Under the Backup File Contents section, a list of files will

appear. Highlight the Lunar.mdb file. Click OK. *See figure 19

Fig.19

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26. A warning message will appear. Click OK. *See figure 20 Fig. 20

27. A status bar will appear in the lower left hand corner of the

Directory screen. Once it reaches 100%, a window should appear stating, “Backup files have been successfully restored”. Click OK. *See figure 21

Fig. 21

The patient database from disk 1 should be on the new computer. 28. Now the customer’s calibration information can be restored

onto the new computer. To do this, click on Directory at the top of the screen. A drop down menu will appear. Choose Database Utilities and Restore Backup. *See figure 22

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Fig. 22

29. A Restore Backup window will appear. Insert the customer’s

last archive disk. *See figure 23

Fig. 23

30. There is a file on the Archive disk called

“ProdigyBackup.zip”. This file must be browsed to, by clicking on the Browse button. A Browse for Folder window will appear. *See figure 24

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Fig. 24

The ProdigyBackup.zip will be located at A:\Archive\Data. The Data portion of the path must match the working path of the directory. If the archive disk is for a database with a working path of Data2, then it will be Data2 rather than Data. 31. Click OK. The Browse for Folder window will disappear,

revealing the Restore Backup window again. 32. Under the Backup File Contents section, a list of files will

appear. Click the Select All button. All of the files in the Backup File Contents will be highlighted. Hold the <Ctrl> button down and single click the Lunar.mdb file to deselect it. Click OK. *See figure 25

Fig. 25

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33. A warning message will appear. Click OK. *See figure 26 Fig. 26

34. A status bar will appear in the lower left hand corner of the

Directory screen. Once it reaches 100%, a window should appear stating, “Backup files have been successfully restored”. *See figure 27

Fig. 27

At this point all the calibration information from the old computer should be on the new computer.

****If the Restore backup procedure does not workthen repeat the process. If it still does not work then call Customer support for help.

35. On the directory screen, click the Restore button at the top of the screen. *See figure28

Fig. 28

36. A Restore window will appear. Place a dot next to the choice, “Restore all exams for all patients”. This will be worded “Restore

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all images for all patients”, in older software versions. Click OK. *See figure 29

Fig.29

37. The computer will ask you to insert Disk 1. *See figure 30 Fig. 30

Place the archive disk 1 in the LS120 drive and click OK. The computer will commence moving the image or exam files from archive disk 1 to the database directory. 38. Once completed, disk 1 should be devoid of scan files. Exit out of

the Encore software. 39. In Windows Explorer, copy just the scan files from disks 2 and up,

into the database directory. *** Call customer support if you run into problems copying scan files to the database directory.

40. After all the scan files from all the archive disks reside in the database directory, they must be rebuilt in the Encore software. Open up the Encore software and go to the Directory screen.

41. On the left hand side of the screen, click Rebuild Database. *See figure 31

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Fig. 31

42. A Rebuild Database window will appear. Make sure Working

Directory is set under Source Options. A list of scan files should appear in the left hand side of the window. Click the Select All button. All the scan files should be highlighted. Click OK. *See figure 32

Fig. 32

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43. The computer will commence a rebuild. A status bar will appear

in the lower left hand corner of the screen. It will be finished when 100% is reached. *** If the rebuild completes with errors, make sure that the customer has all the correct features activated. If not change feature code to activate them and repeat rebuild process.

44. Repeat steps 21 to 43 for any additional databases. Do not perform the second Restore from backup in steps 29 through 34 for databases other than the main one.

45. Once all the databases are restored and rebuilt back into the new computer, exit out of Encore and shut the computer down.

46. Disconnect the LS120 drive from the new computer. 47. Reconnect the floppy cable to the floppy drive, along with the

appropriate power cable. 48. Reconnect the IDE cable back to the Zip250 drive. 49. Close case and boot computer. 50. As the computer is booting up, press <F2> to enter the BIOS

setup. 51. Re-enable the Floppy controller. 52. Save the changes and exit. Let the computer boot up. 53. In Windows, verify that the floppy drive can read floppy disks and

is being recognized as drive A:. Verify the drive letter assigned to the Zip250 drive.

54. Enter the Encore software. 55. On the Directory screen, click on Edit Database on the right hand

side of the screen. *See figure 33 Fig. 33

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56. An Edit Database window will appear. Change the Archive Drive

to the drive letter assigned to the Zip drive. Click Ok. 57. Repeat steps 55 and 56 for each database. 58. Archive each database to Zip250 disks.

4. Computer Swap – Quality Assurance

a. Perform a QA. b. Measure a phantom c. Analyze the phantom d. Print e. Archive f. Open and print 3 different patient scans.

i. Compare these to printouts obtained from the customer to ensure they are the same.

GENERATED RECORDS List any documentation that is produced as a result of, or to provide evidence of a task being completed; specifically quality records. If none type “None.” ex. EXMA0004 - Expert Base Initial Electrical Assembly Quality Record

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DOC. ID: DXAP2000 REVISION: N DATE: 8/13/01 WRITTEN BY: Jeff Franz

MANUFACTURING PROCEDURES

GE Medical SystemsLUNAR

g

APPROVED ON CO: 7012

TITLE: Prodigy Installation Work Instructions

PURPOSE This procedure describes the steps necessary to assemble a PRODIGY scanning system at a customer's site, and to assure that the system is operating within GE-LUNAR's specifications and in compliance with applicable Federal and State regulations.

APPLICATION This procedure applies to all employees performing installation of a PRODIGY scanning system.

SAFETY PRECAUTIONS The x-ray generator produces a beam of ionizing radiation. The technician should take precautions to avoid exposing any part of their body to the x-ray beam. The PRODIGY scan table contains high voltages, the technician should take precautions to prevent electric shock.

ASSOCIATED MATERIALS DXAP0002 DEXA External Options Installation Procedure DXAP2001 PRODIGY Source/Detector Alignment DXAP2003 PRODIGY Installation Test Procedures DXAP2004 PRODIGY Installation Report DXAP2010 enCORE Centerline Offset Procedure DXAP2013 PRODIGY Split Frame Installation Procedure DXAP2015 PRODIGY Arm Slot Cover Installation DXAP2023 PRODIGY USA Label Instructions DXAP2024 PRODIGY Canada Label Instructions DXAP2025 PRODIGY France Label Instructions DXQC2022 PRODIGY Aluminum Spine Phantom Scan Procedure DXPC2000 DPX-Fan/DPX-NT PC Configuration Procedure DXAP3030 Small Room Kit Installation Instructions

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DEFINITIONS PRODIGY I Systems are defined as scanners with system numbers 11999 and lower. PRODIGY II Systems are defined as scanners with system numbers 12000 and greater. PRODIGYIII Systems are defined as scanners with system numbers 13000 and greater.

PROCEDURES 1. PREPARATION

A. Begin the installation by filling out the initial customer information on the

PRODIGY Installation Report DXAP2004. B. The remainder of the Installation Report (DXAP2004) will be completed

during procedures DXAP20001, DXAP2002 and DXAP2003.

2. UNCRATING THE SCAN TABLE

A. Remove table assembly from shipping crate by removing the Phillips head screws along the bottom edge of the shipping pallet.

B. Lift the tri-wall cardboard top off of the scanner pallet. C. The scan table assembly is attached to the wood blocks supporting it with 4

Phillips head screws. These screws are on the inside of the scan table, through the bottom frame. Remove all four screws.

D. Carefully (using a minimum of two people) lift the scan table straight up and

off of the pallet, so it rests on the ground on the casters.

E. Bring the scan table into the room. It may be placed on its back on a 4-wheel dolly (with all external panels off) if necessary.

F. If door and hallway clearance of the customer’s facility require, the scan table

may be split according to procedure DXAP2013 PRODIGY Split Frame Installation Procedure.

G. Position the scan table assembly in the room (on the casters) so the back of

the scanner is accessible (in order to install the arm).

H. Remove the arm assembly from its crate. The arm may only be set down on its backside with the Upper arm and lower extrusion pointing up.

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NOTE: The outer covers of the scan arm are fiberglass, be careful, as they will scratch or fracture easily – do not remove the foam wrapped around the arm until it is in the room where it will be installed. I. Carefully bring the scan arm assembly into room where scanner is to be

installed. Carefully remove the packing materials wrapped around the arm. J. Bring the other cartons containing the Host computer and peripherals, and

any accessories shipped with the system into the room where the scan table is to be installed and carefully unpack them

NOTE: The End Panels, Upper and Lower Back Panels, Back Ledge, Front Panel and Front Rail Cap are in the Shipping Box. K. Upon unpacking at the customer's site, verify all of the equipment listed on

the packing slip has arrived, checking the contents of the cartons against the pick list shipped with the scanner. Check off each item on the pick list as it is unpacked; include the completed pick list with the Installation Report. If there is evidence any equipment has been damaged in shipment, or if items are missing, notify GE-LUNAR Customer Care immediately. USA installers should call the DOA Hotline at 1-800-365-8627 Extension 7239.

2. MOUNTING THE SCAN ARM

A. Remove tabletop from the table assembly by removing the four 8-32 socket head screws in the tabletop.

B. Remove the two screws holding the L-shaped bracket on the high voltage

cable trough to the front longitudinal carriage. The High voltage cable trough should be wire tied to the transverse extrusion to keep it up and out of the way when the arm is mounted.

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C. Remove the front longitudinal carriage (three flathead screws) from the arm. D. Loosen the two 1/8-inch drive cable clamp screws on the bottom of the front

longitudinal carriage such that the drive cable can be slid under the clamp.

E. Slide the rollers on the front longitudinal carriage onto the front longitudinal track located on the frame assembly. Keep the carriage as far as possible towards the head end of the table assembly.

F. Slide the Front Longitudinal drive cable under the cable clamp on the front

longitudinal carriage. DO NOT tighten the cable clamp screws.

G. Gently pull the Longitudinal Drive Cable up and out of the way at the head end of the scanner, being careful not to stress the cable – pull it only as far as is required.

H. Clip the wire-tie that is holding the source / carriage (note source is on the

arm for PRODIGY II/III systems) to the back of the arm.

I. Remove the two lower adjustable wheels from the rear longitudinal carriage plate using 2-7/16” wrenches.

J. PRODIGY II/III Only - PRODIGY II/III is shipped with the source factory

aligned on the arm – place a wire tie around the extrusion on both sides of the source to hold the source in place in the center of the extrusion.

K. At the head end of the table where the cutout in the rear trough is, hold the

arm upright and position the arms lower transverse extrusion through the back of the table (see figure 1).

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13 2

Long Column

Short Column

FIGURE 1: When the arm is to be mounted it should only be allowed to rest on its back as in the illustration under the number 1 in this figure.

L. Lift the arm and hang the four wheels of the rear longitudinal carriage onto t the

upper longitudinal extrusion (this is easier if you tilt the front of the arm slightly downward).

NOTE: Be careful not to damage longitudinal and transverse belts or any components on the electronics pan.

M. Have a helper balance the arm in an upright position while you slide the front

longitudinal carriage into position and attach it with a flat head screw to the end of the lower transverse extrusion – do not completely tighten the flat head screw.

N. Re-attach the two adjustable wheels to the rear carriage, do not adjust at this

time. Cut the wire tie holding the transverse belt and run it onto the pulleys on the transverse motor and the pulley on the front longitudinal carriage.

O. Tighten the 3 flathead screws which attach the front longitudinal carriage to the

arm’s lower transverse extrusion.

P. Mount the OMI board on the 1/8” hex head screw on bottom of the front longitudinal carriage. Be sure it is properly adjusted so that the wheel between the slots fully blocks the infrared beam of the transducer. As the wheel rotates, each wheel slot should be aligned with the centerline of the transducer window.

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3. ELECTRICAL ASSEMBLY

A. Clip the wire tie holding the longitudinal cable track to the frame.

B. Remove the protective bag covering the longitudinal cable track cables and run the cables and longitudinal cable track into position, taking care not to contaminate the high voltage connectors for the x-ray tube head (PRODIGY II/III).

C. Run the longitudinal belt onto its idler pulleys.

D. The x-ray tube housing assembly is shipped upside down in a shipping

bracket in the scanner on PRODIGY I systems – PRODIGY II/III systems are shipped with the source pre-aligned on the arm. If the scanner is a PRODIGY II/III Proceed to step x of this section.

E. PRODIGY I ONLY Unbolt the tube housing assembly from the tube housing

assembly shipping bracket. It is held in place by 3 nuts.

FIGURE 2: PRODIGY I Tube housing assembly mounted in transit bracket, the arrows indicate the direction of rotation to correctly orient it for installation.

F. PRODIGY I ONLY: Turn the tube housing assembly toward the foot end of the scanner (arrow 1, Figure 2) so that the mounting studs point toward the foot end of the scanner, then holding the tube housing assembly by the sides flip the tube housing assembly over (arrow 2, Figure 2) without rotating the tube housing assembly.

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NOTE: If you leave the series of concave washers (Belleville washers) on the single stud they can serve as a guide for tipping the tube housing assembly into place correctly, if the washers fall off the stud, the tube has been tipped the wrong way.

G. PRODIGY I ONLY: Insert the top stud into the hole on the source carriage,

insuring that the Bellville washers are in place and put the nut back on the top stud to hold the tube housing assembly in place.

H. PRODIGY I ONLY: Replace the other two nuts on the two lower tube

housing assembly mounting studs on the tube housing assembly tilt bar.

I. PRODIGY I ONLY: Remove the shipping bracket from the pan (four bolts) and reattach it to the pan, with one bolt, laying it down flat.

J. PRODIGY I ONLY: Place the other 3 bolts for the mounting bracket in the

front rail. This is done for transporting the Tube housing assembly in the future should the scanner be moved.

K. Attach the cable track to the rear longitudinal carriage, the cable track

attaches to the rear longitudinal carriage bracket using (2) 10-32 x 1/2 BHCS.

CAUTION: Do not apply power to any of the electronics until connections have been checked at least twice for accuracy.

CAUTION: Do not connect or disconnect any wires with power applied to system. A. Neatly separate the following cables

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FIGURE 3: Cable Connections and layout at the rear longitudinal carriage I. OMI Cable (small gray cable, which goes to the transverse motion

detector from the bulkhead). II. Tube housing assembly Cable (large black wrapped bundle which is

connected to the tube housing assembly) III. Signal Cable (DB-9) IV. Ground cable (green/yellow cable) V. Bulkhead cable (bundle with two Molex connectors).

B. PRODIGY I ONLY: Lay the red Centent cable to the Centent (make sure red

cable is routed above longitudinal drive belt and on top of the high voltage cable trough, and under the black High Voltage cable bundle) and make connections to the Centent as Illustrated in Figure 4.

C. PRODIGY I ONLY: Hook up the transverse motor wires (over red Centent

cable, below Tube Head bundle) to the Centent in the proper configuration (see figure 4).

Bulkhead Connectors

Cable Track

Signal Cable

Red CENTENT Cable

CENTENT Motor Cable

Ground Cable

X-ray tube housing assembly Cables OMI

Cable

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GROUND

PHASE C

POWER SUPPLY GND.

+24 TO 60 VOLTS DC

PHASE A

PHASE B

PHASE D

NC

DIRECTION

STEP PULSE

+5 VOLTS DC

CURRENT SET

CENTENT CNO142

GreenBlue

BlackRed

Red/BlackWhite

OrangeUnused

See Charts

FIGURE 4: CENTENT Wiring

CAUTION: If a transverse stepper motor is not wired properly, it may stall or cause other motion errors.

Centent Pin # AMP Motor 3 Red 4 Blue 5 Green 6 Black

TABLE 1: Transverse CENTENT Motor Wires

NOTE: Throughout the following steps, wire ties will be used. Do not snug them too tightly, as damage to the cables will result.

D. PRODIGY I ONLY: Wire-tie the red Centent cable and the transverse motor

wires bundle to the high voltage cable trough (see figure 3).

3 4 5 6

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CAUTION: Secure all cables such that they do not contact the transverse motor (it gets quite hot).

E. Lay the small gray cable (OMI cable) in place along the outside (toward head) of the high voltage cable trough and connect it to the transverse OMI (Optical Motion Indicator) board (see figure 3).

F. Route the x-ray tube housing assembly cables along the longitudinal carriage

bracket, to the bulkhead bracket (see figure 3).

G. Connect the DB-9 cable at the bulkhead and tighten the mounting screws (signal cable – see figure 3)

H. Connect the Molex connectors labeled "Bulkhead 1" and "Bulkhead 2" to the

appropriate bulkhead connectors (see figure 3).

CAUTION: PRODIGY I ONLY: Be sure to attach the Bulkhead connectors correctly, if the Bulkhead connectors are reversed the Power on LED on the display panel will be damaged.

I. Connect the green/yellow ground cables to the rear carriage near the

protective earth label (see figure 3).

NOTE: The protective earth label must be in place and only green/yellow wires may be attached near it.

J. Connect the green/yellow ground cable with the spade connector to the

green/yellow ground cable at the bulkhead. K. PRODIGY II/III ONLY: Wipe the inside of the cathode and anode

receptacles and the outside of the high voltage cables with a lint free rag and ethyl alcohol. Take care not to contaminate the connectors or the receptacles after they have been cleaned.

L. PRODIGY II/III ONLY: Place a drop of silicone oil in the center of the

cathode cable and a light bead of silicone oil on the outside of the cathode connector, then gently insert the connector into the cathode receptacle on the tube housing assembly (see figure 5).

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FIGURE 5: PRODIGY II/III High Voltage connector – the arrows indicate where to place the drops of silicone oil – note also that the connectors are keyed.

M. PRODIGY II/III ONLY: Tighten the retaining ring by hand until snug, and then

tighten the 1.5mm grub screw to lock the ring into position. N. PRODIGY II/III ONLY: Repeat steps L and M for the anode high voltage

cable.

O. PRODIGY II/III ONLY: Attach the ground wire (green with yellow stripe) to the marked ground at the base of the tube housing assembly as illustrated in figure 4.

NOTE: The protective earth label must be in place and only green/yellow wires may be attached near it. P. PRODIGY II/III ONLY: Connect the two and six pin Molex connectors for the

fans and the collimator, wire tie the cables into place as illustrated in figure 6.

Q. Re-attach the high voltage cable trough to the front longitudinal carriage with the hardware that was removed.

R. Make sure that the front side of the high voltage cable trough is biased as

high as possible, without causing the bottom of the tube housing assembly to collide with the CENTENT.

Oil here

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S. Wire tie the cables in place to the two anchor positions on the rear longitudinal carriage (see figure 3).

T. Anchor the tube housing assembly cables to the high voltage cable trough.

There are four tie down locations toward the rear of the trough panel. U. The tube housing assembly cables should be tied down first in such away as

to create an arch in the cable as it leaves the cable track. This is to allow some slack in the cable when the arm moves to the foot end of the table.

V. Tie the OMI cable on the head end of the high voltage cable trough using the

two tie downs and tying to the four wire ties, securing the tube housing assembly bundle.

W. Tie the OMI cable to the tube housing assembly bundle an additional time

near the bulkhead. Tie to High Voltage bundle, also between trough and bulkhead.

R. Assure that all cables and bundles lie neatly, do not bend sharply, and are

securely in place. Wire ties should be placed where provision is made (anchors mounted to frame); wire ties should also be used to neatly bundle wires.

CAUTION: DO NOT over tighten the wire ties.

S. Install the PRODIGY Collimator on the X-ray Tube Housing Assembly and

tighten down with the 4 5/32 hex head screws provided.

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FIGURE 5: PRODIGY II/III Tube housing assembly cable dressing

T. PRODIGY II/III ONLY: Wire tie the anode and cathode high voltage cables to the L-shaped bracket on the base of the tube housing assembly (see figure 5).

U. PRODIGY II/III ONLY: verify the tube housing assembly thermostat

connection at the top of the x-ray generator.

7. AC ENTRANCE / ELECTRICAL INSPECTION

A. Install the scanner AC power cord by inserting the cord through the hole in the

scanner near the AC entrance and using the screws provided to mount the strain relief plate.

B. Run the power cord out from under the scanner to the outlet to be used, but

do not plug in.

Wire Ties

Ground Screw

Molex Connectors

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C. Re-check all electrical connections made. D. Check to see each printed circuit board is firmly mounted and properly

connected.

E. Check the other electrical assemblies to make sure they are firmly mounted and properly connected.

F. Check to see that a 20-amp or greater service is supplied to the room. It

must be dedicated to the system.

G. Install any external options if the scanner is equipped (see DXAP0002).

H. PRODIGY I ONLY: Determine the regional AC line levels by setting a meter for AC voltage measurement and at least 250 VAC full scale. Carefully measure the line voltage at the outlet that is going to be used to power the scanner.

I. PRODIGY I ONLY: Look up the AC voltage measured in table 2 and note

the recommended jumper setting in figure.

J. PRODIGY I ONLY: Set the AC Entrance jumpers on the primary terminal block according to the illustration in figure 8 for the appropriate AC voltage measured in step C.

CAUTION: Be sure the AC power cord is not plugged into the wall outlet before moving jumpers.

NOTE: The Isolation Transformer (PRODIGY I) / Power Supplies can handle occasional over voltage (surge) situations, but under voltage (brown out) situations can cause premature failure of the X-ray generation subsystem. The Isolation transformer will function correctly as long as the AC power coming in to the scanner is within 10% of the jumper setting. If the regional AC conditions occasionally fluctuate by 10% or more the use of an Uninterruptible Power Supply is advised, contact GE-LUNAR Customer Care for information.

Meter Reading (VAC)

Jumper Setting

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90 – 105 VAC 100 VAC 106 – 113 VAC 1 110 VAC

114 –118 VAC 115 VAC 119 – 123 VAC 120 VAC 124-126 VAC 125 VAC 127- 140 VAC 127 VAC 180-210 VAC 200 VAC 211- 226 VAC 220 VAC 227-236 VAC 230 VAC 237-246 VAC 240 VAC 247-252 VAC 250 VAC 253-279 VAC 254 VAC

Table 2: PRODIGY I AC Entrance Recommended Jumper Settings

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FIGURE 6: Primary AC terminal block jumper configurations

K. PRODIGY II/III ONLY: systems will automatically configure themselves for

the regional AC conditions. L. PRODIGY I ONLY: Refer to the appropriate labeling instructions depending

on the country where the scanner is being installed.

1. USA - see DXAP2023 PRODIGY US Label Installation Instructions 2. Canada – see DXAP2024 PRODIGY Canada Label Installation

Instructions 3. France – see DXAP2025 PRODIGY France Label Instructions

M. If one of the instructions above do not apply, place the appropriate voltage

configuration label (if necessary) to the PRODIGY I’s system label on the foot end panel. Labels are found in the destination kit, p/n 7830 for 220-240 VAC systems and p/n 7829 for 100 V systems.

N. PRODIGY I ONLY: Review the following conditions carefully and decide

which power set up option best suits the room in which the scan table is being installed.

CAUTION: The following is in accordance with IEC 601 and UL safety regulations. NOTE: The PRODIGY I scanner’s output power strip can be used to supply the Host PC with isolated power. If it is to be used the following conditions must be met. If the conditions cannot be met, the scanner’s output power strip cannot be used.

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1. If the PRODIGY I Scanner power (isolated power) is to be used:

a. The strip must be mounted – it cannot be on the floor. b. The strip should be mounted away from an edge – it may not

come into contact with other equipment. All other (non-isolated) electrically powered equipment must be 1.83 meters (6 feet) from the scan table.

c. The computer and all peripheral devices (monitor, printer, external disk drive, etc.) must be all powered from the outlet strip.

d. The Host computer may not be connected to a network or to a modem unless the network and / or modem is / are optically isolated from the Host PC.

e. The Host PC may be placed anywhere in the room. 2. If the scanner isolated power is not used (wall outlet):

a. No devices are to use the scanners isolated power output. b. The Host PC may be connected to a modem or to a network

without optical isolation. c. The Host PC, peripherals and any other electrically powered

equipment must be placed a minimum of 1.83 meters (6 feet) from the scan table.

O. PRODIGY I ONLY: If the PRODIGY I scanner’s isolated power is to be

used, run the output AC power cord to the area where the Host PC will be installed. If the scanners isolated power will not be used neatly coil the power cord and store it under the scan table.

P. PRODIGY I ONLY: If the isolated AC power strip is to be used, verify the AC output jumper settings on the secondary terminal block are correct for the Host PC and peripherals to be used as illustrated in figure 9.

Q. PRODIGY II/III ONLY: Install the external Isolation transformer as described in

DXAP3030 Small Room Kit Installation Instructions.

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FIGURE 7: PRODIGY I Isolated AC Power strip jumper settings

11. COMPUTER, PERIPHERAL AND CABLE SETUP

A. Remove all components from the boxes. B. Position the computer, monitor, and printer on the console table. If the

scanner’s isolated power or the isolation transformer included in the small room kit is to be used, the Host PC can be anywhere in the room. If the scanners isolated power, or isolation transformer is not used, the Host PC must be at least 1.83 meters (6 feet) from the scan table.

C. Connect the monitor, keyboard, mouse, and printer to the computer.

D. Feed the supplied paper and ink cartridges into the printer according to the

printer manufacturer’s instructions.

E. Connect the printer to LPT1 on the Host PC.

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F. Connect the monitor to the Host PC’s video card.

G. Position and set up any optional peripherals according to the manufacturer’s instructions and connect them by cable to the computer.

H. Using the cables supplied, connect the scan table to the Host computer. The

scan table uses RS-422 communications, this is via a serial card installed in one of the Host computers expansion slots. Host PC’s supplied by LUNAR have the card installed and configured. If the card needs to be installed, use procedure DXPC2000 PRODIGY / DPX-NT PC Configuration Procedure.

I. Make sure that all I/O cables are fastened at both ends to their respective

connections (by screws or clamps).

J. Verify the I/O cable at the scan table is connected tight at the HOST RS-422 (J5) connector of the controller ((c)SBC).

K. Verify that the Host PC’s input voltage select is set for the AC voltage of the

scanners isolated power or the AC voltage of the wall outlet.

L. Verify that all peripheral devices are compatible with the AC voltage of the scanners isolated power (step 8-E) or the AC voltage of the wall outlet.

M. Plug each of the AC power cables into the Host PC and peripherals set up

above into the isolated power strip, an external non-isolated power strip or the Isolation Transformer.

N. Plug the scan table power cord into the wall outlet that was checked

previously. If the scanner’s AC output is not being used, plug in the outlet strip for the Host PC and peripherals.

O. Turn on the scan table, computer, monitor, printer and any peripherals, in that

order.

12. SOFTWARE VERIFICATION / DIAGNOSTIC SOFTWARE INSTALLATION

A. When the computer boots, log in as Administrator. B. Verify that the Host PC does not have a screen saver turned on and that all

power management is turned off.

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C. If necessary, configure the Host PC to run the enCORE – PRODIGY software by following procedure DXPC2000 – DPXFan/DPX-NT PC Configuration Procedure. Return to this procedure after completing DXPC2000.

D. Start the enCORE Software by double clicking the PRODIGY Icon on the

desktop.

E. Verify that the software version shipped with the system is the same as the software version shipped on CD-ROM, if there is a discrepancy, load the software on the CD-ROM.

F. From the PRODIGY main menu, go to Options / User Options / System Tab

and enter the system number and feature code found on the PRODIGY software CD-ROM shipped with the system.

1. Tube Head Warm Up

A. Power up the scan table by turning on the power switch at the foot end of the scan table. Power up the host computer and all peripheral devices.

B. Enter the Service Mode of the Fan Software Options / User Options Service – Enter Password (Smile sw ver 1.0 – 2.05 or Award ver 2.10 +)

C. Go to Tools / Diagnostics / Scanner X-Ray (as shown in Figure 2).

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Figure 2: Scanner X-ray Test Menu

D. Click on the warm up Button as indicated in Figure 2. This process will gradually increase kV to warm the tube head insert, it will take approximately 40 minutes.

NOTE: While the Tube Head warm up is running, you may continue with the

procedure.

x. BACK PANEL and ARM SLOT COVER INSTALLATION

A. Adjust the eccentric wheels v-wheels using two 7/16 wrenches and a 9/16 wrench.

NOTE: The scan arm on the PRODIGY scanner is supported by a series of concentric (stationary) and eccentric (adjustable) bearing rollers (V wheels). The concentric rollers primarily carry the load of the arm. The eccentric rollers are

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used to stabilize and position the arm, and to adjust the free play in the mounting of the arm. A. By rotating the adjustable bearing roller on its mounting bolt, the clearance

between the wheel and the track can be adjusted.

NOTE: Normal adjustment is obtained by rotating the eccentric bearing roller with a 9/16-inch wrench, while holding the bolt that goes through the wheel with two 7/16-inch wrenches. The 7/16 bolt should be tight, and the adjustable bearing roller wheel should be tight enough that the wheel rotates when the arm is moved longitudinally, but it can be turned against the track by hand. CAUTION: If the adjustable bearing roller is over-tightened it can exert a force greater than the load rating of the longitudinal drive system, causing the slip clutch to release or the belt to jump teeth.

B. Attach the upper and lower back panels using the hardware provided (see figure

10 – page 25 of this instruction) and sure to reconnect the green/yellow ground wires near the protective earth labels (P/N 17231).

a. Adjust the rear panel height by performing the following: b. Move the scan arm to either the head or foot end of the scan table.

FIGURE 3: Adjusting the lower back panel height using a 5/32 allen key

as a guide.

c. Use a 5/32 allen key as a gauge to set the panel height (see figure 3). d. The 5/32 allen is placed on the top edge of the lower arm slot cover

guide and fits between it and the transverse extrusion. i. This provides just enough sag room for table flex when a heavy

patient is scanned, but keeps the lower panel high enough to keep the slot cover in the guides.

e. Repeat the adjustment for the opposite end of the scan table.

C. Install the Arm Slot Cover see DXAP2015 for detailed instructions

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D. Move the scan table to its final position in the room, with six to eight inches

between the wall (2 to 3 inches minimum) and the back of the arm.

E. Unscrew the casters from the bottom of the legs and replace them with glides. Store the casters inside the scanner in the front trough behind the door.

NOTE: Be careful, as the scan arm may roll away from side of the scan table being elevated.

F. With the scan arm in the center of the table, level the scan table by placing a

torpedo level alternately on the front, rear, and sides of the frame and adjust the heights of the glides to make the table level. Once the table has been leveled, it must not be moved.

G. Attach the Rear Longitudinal Drive ground cable to the cable clamp via clamp

screw. Place the upper rear longitudinal drive cable into the clamp on the longitudinal carriage keeping the turnbuckle on the head end of the clamp. Move drive cable relative to clamp so as to take up any slack in the ground cable. Tighten the clamp.

NOTE: Make sure the extrusion that carries the source is perpendicular to the front longitudinal rail H. Verify the lower front drive cable is in the clamp mounted on the front longitudinal

carriage. Verify the arm is perpendicular to the centerline of the table and that this is the natural position (i.e., no force is necessary to maintain this position). Then tighten the front clamp, accessing it from the bottom at the front of the scan table; tighten the two 1/8” hex head screws.

I. Place the head and foot end panels on the scanner (do not put the panel screws

in). J. Place the front panel and the upper front panel cap on the scanner (do not put

the panel screws in).

K. If the tube head warm up is still running, remove the upper and lower arm panels.

L. If the tube head warm up is still running, sort the panel attachment hardware according to Figure X.

13. TUBE HEAD ALIGNMENT

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A. After the tube head warm up is finished, align the tube head as instructed in the Procedure DXAP2001 PRODIGY Source-Detector Alignment. The arm upper cover may be left off until the limit switches have been verified.

14. INSTALLATION TESTING AND CALIBRATION

A. Perform the System function verification test as outlined in DXAP2003 PRODIGY Installation Test Procedures.

15. ATTACH PANELS

A. Using the illustrations in Figure 6 attach the Front, and Side panels to the scanner if they have not been mounted with the appropriate hardware (also illustrated in Figure 10).

B. Attach the tabletop using the 4 countersunk 8-32 1/8 inch socket head screws.

C. Place the table pad on the scanner in the correct orientation (zipper end at foot) and perform procedure DXAP2010 enCORE Centerline offset Procedure. When this procedure has been completed return to these instructions to complete the installation.

D. Coil and wire tie excess power cords neatly under the scanner.

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FIGURE 10: Outer Panels and Hardware

16. RECORDS

A. (U.S. Installs Only) - Completely fill out form FDA 2579 - Report of Assembly of a Diagnostic X-Ray System. Leave the appropriate copy (pink) with the customer and mail the yellow and white copies to GE-LUNAR, the blue copy stays with the installation paperwork.

B. Verify all compliance labels are affixed to the system are legible, and

completely filled out: If labeling is incomplete or inaccurate, contact GE-LUNAR Customer Support.

NOTE: US ONLY- these forms must be submitted to the federal and state agencies within 15 days of the install. It is imperative they are completely filled out and returned (yellow and white copies) to the GE-LUNAR Customer Support Department as quickly, as is possible.

C. Verify that all Scan Types in the PRODIGY software listed on the Software

Order form can be accessed.

D. Verify the system number entered matches the system number recorded on the delivery receipt.

E. Create an Emergency Repair Disk (ERD).

Click on START/ RUN in the dialogue box type rdisk Label a blank 1.44 MB 3 ½ floppy disk “EMERGENCY REPAIR DISK” Click on the Create Repair Disk button on the Repair Disk Menu Follow on screen prompts to create ERD. When process is complete (Floppy drive light is off) eject ERD. Place ERD with WINDOWS NT CD-ROM and Diskettes. Exit Repair Disk.

F. Complete the installation page of the Product Locator Card and return to the

appropriate pole as indicated on the card.

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G. (U.S. Installs only) Complete the system ID field on the GE-CARES support labels found in the software box. Apply one of the labels to the front of the host PC. Leave the other lable for the customer to place near their phone.

H. Verify that all relevant portions of DXAP2004 PRODIGY Installation Report

are complete; this is submitted to the Applications department upon return to GE-LUNAR. After review, this report becomes part of the systems Device History Record.

I. U.S. Installs Only) - Have the customer sign the delivery receipt and verify the

date of the applications training (if applicable).

J. Return all Installation paperwork to GE-Lunar

GE-LUNAR Attn: Installation Paperwork 726 Heartland Trail Madison, WI 53705 USA

GENERATED RECORDS DXAP 2004 FDA Form 2579 (USA only) Product Locator Card Delivery Receipt

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DOC. ID: DXAP2001 REVISION: J DATE: 8/13/01 WRITTEN BY: Jeff Franz

MANUFACTURING PROCEDURES

GE Medical SystemsLUNAR

g

APPROVED ON CO: 7012

TITLE: Prodigy Source Detector Alignment Procedure

PURPOSE

This procedure provides work instruction for personnel warming up and aligning the x-ray source and detector for the PRODIGY.

APPLICATION

This procedure applies to all service / applications personnel installing or repairing a Prodigy system with version 2.26 or greater software.

SAFETY PRECAUTIONS

X-ray generator produces beam of ionizing radiation. The technician should take precautions to avoid exposing any part of their body to the x-ray beam.

ASSOCIATED MATERIALS

DXAP2000 Prodigy Installation Procedure DXAP2003 Prodigy Installation Test Procedures DXAP2004 Prodigy Installation Report Form DXAP2006 Prodigy Dial Indicator Alignment Verification DXAP2011 enCORE Beam Wobble Procedure

DEFINITIONS PRODIGY I Systems are defined as scanners with system numbers 11999 and lower. PRODIGY II Systems are defined as scanners with system numbers 12000 and greater.

PROCEDURES

1. Prepare the System for Alignment

A. If the tabletop and the arm shroud covers are on the scan table, remove them now.

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I. Upper arm shroud hinges at the front, is held in place by two 5/32’” hex head screws into the back of the arm column.

II. Lower shroud is attached by 10 hex head screws, 4 at the front and 6 at the rear. The back cover of the arm column must be loosened at the top to gain access to two of the screws. Use the foam leg block to support the lower shroud while removing it. Be sure to disconnect the ground wire for the metal portion of the lower shroud.

2. PRODIGY I ONLY or TUBE HEAD REPALCEMENT ON PRODIGY II: Rough Alignment: Point to Point.

NOTE: Installation of PRODIGY II Systems skip section 2 and procede to section 3.

A. PRODIGY I ONLY: Install the film holder on detector by holding one latch pin on each side of film holder, sliding film holder along detector and releasing latch pins into dimples on the detector when the two locator pins inside film holder find the two locator holes on the underside of the detector.

B. PRODIGY I ONLY: Move detector/arm to center of table.

C. PRODIGY I or TUBE REPLACEMENT ONLY: Remove the collimator assembly (if it is on the tube head).

D. PRODIGY I or TUBE REPLACEMENT ONLY: Attach the Prodigy Alignment rod to the top of the tube head using the two 5/32” screws. These screws mount the alignment rod on the top of the Prodigy tube head in the same position as the collimator. The access hole in the alignment rod base should be toward the head and front end of the table.

E. PRODIGY I or TUBE REPLACEMENT ONLY: Adjust the length of the alignment rod by loosening the 9/64” (8-32) screw on the collar on the alignment rod. Pull the rod up, so its position relative to the film holder can be easily determined. Be careful not to damage the film holder by contacting it with the sharp end of the alignment rod.

F. PRODIGY I or TUBE REPLACEMENT ONLY: Adjust tube head in the transverse direction by using the tilt bar (loosen the 3/8” hex nut) such that the point on the alignment rod is aiming for the transverse center of the film holder.

NOTE: Tightening the tilt bar adjustment 5/32” hex head screw tilts the Tube Head toward the front; the effect of the tilt bar is unidirectional, it will only tilt the tube head toward the front of the table (see Figure1). If the adjustment screw is

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used to tilt the Tube Head too far toward the front, it must be repositioned toward the rear and readjusted forward again. Be sure to retighten the 3/8 hex nut to lock the tilt bar in position and tighten the two lower tube head mounting nuts (7/16”).

G. PRODIGY I or TUBE REPLACEMENT ONLY: Adjust the tube head in longitudinal direction by turning the spring-loaded nut at the top of the tube. This will compress or decompress the Belleville washers, which serve as a spring. Tighten or loosen the spring-loaded nut so that the point of the alignment rod is on the cross hairs of the film holder. At this time also verify that the lower two nuts that mount the tube head are tight.

FIGURE 1: Tube Head with Alignment Rod Installed – pointing at Film Holder (High voltage cable trough is not shown)

H. PRODIGY I or TUBE REPLACEMENT ONLY: At this point remove the alignment rod.

I. PRODIGY I or TUBE REPLACEMENT ONLY: Install the shutter assembly on the tube head with the four 5/32” hex head screws; also reconnect the Molex connector for the shutter electronics. Make sure the Molex connector is wire tied to the tube head so that it will not get caught between the collimator assembly and the frame when the tube head moves to home position.

Alignment Rod

Film Holder / Alignment Jig

Tilt Bar

Side View – Front to Rear End View – Head to Foot

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3. Tube Head Warm Up (If this has been performed as part of a PRODIGY II/III Install go to section 4.)

A. Power up the scan table by turning on the power switch at the foot end of the scan table. Power up the host computer and all peripheral devices.

B. Enter the Service Mode of the Fan Software Options / User Options Service – Enter Password (Smile sw ver 1.0 – 2.05 or Award ver 2.10 +)

C. Go to Tools / Diagnostics / Scanner X-Ray (as shown in Figure 2).

Figure 2: Scanner X-ray Test Menu

D. Click on the warm up Button as indicated in Figure 2. This process will gradually increase kV to warm the tube head insert, it will take approximately 40 minutes.

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4. Fine Alignment

NOTE: To speed installation, the Head, Foot and front panels may be attached with the correct hardware (see DXAP2000 figure 6) while acquiring counts for the fine alignment and the alignment photo.

A. Make sure the software is in the service signal monitor mode, if it is not go to Tools/Alignment Aid

B. Using the joystick move the detector / source to the approximate center of the longitudinal and transverse axes.

C. Click on the “Get Reference” button on the alignment aid screen

D. Place the alignment aperture on the collimator as shown in figure 3.

Figure 3: Alignment Aperture

E. Click on the “Get Alignment data” button on the Alignment Aid Main screen.

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Figure 4: Alignment Aid Main Screen

F. On the screen a graph with transmission and detector labels on the x and y axies will appear. The green boxes represent the individual detectors and the red line is the ideal transmission rate (target).

G. The column at the right gives the engineer performing the alignment the rotational, transverse and longitudinal error.

NOTE: PRODIGY II Systems are shipped with the tube head pre-aligned, proper alignment can often be achieved by adjusting the collimators position on top of the tube head by loosening the 4 5/32 collimator mounting bolts and shifting the collimator’s position.

H. Rotational Alignment - limit = +/- 1.0 degree – if necessary adjust with screws 1,2, 5 & 6 (see figure 5 ).

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Prodigy Collimator top view Prodigy Collimator top view (old style) (new style)

Figure 5: Top view of PRODIGY Collimators – numbers indicate alignment adjustment screws

Figure 6: Overview of PRODIGY Fine collimator Alignment

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1. If the rotational value is positive, the collimator requires clockwise

rotational adjustment:

a. Loosen screws 5 & 6.

b. Slowly tighten approximately ¼ turn for each degree of rotation (it may be necessary to loosen screw 7 to allow for enough rotation).

c. Take Reference and alignment data and continue to adjust until the rotational error is within 1.0 degrees of zero

d. Retighten screws 5& 6.

2. If the rotational value is negative, the collimator requires a counter-clockwise rotational adjustment:

a. Loosen screws 5 & 6.

b. Slowly tighten screw 7 ¼ turn for each degree of rotation.

c. Take Reference and alignment data and continue to adjust until the rotational error is within 1.0 degrees of zero

d. Retighten screws 5 & 6.

I. Longitudinal Alignment - Limit = +/- 1.9mm - if necessary adjust with spring washer nut.

1. If the signal on detector 1 is lower than the signal on detector 16, (negative longitudinal error) slowly tighten the spring washer nut (same nut used in rough alignment)., ¼ turn at a time.

2. If the signal on detector 16 is lower than the signal on detector 1, (positive longitudinal error) slowly loosen the spring washer nut (same nut used in rough alignment)..

3. Take Reference and alignment data and continue to adjust until the longitudinal error is within 1.0 mm of zero

J. Transverse alignment – Limit = +/- 4.5 mm – if necessary adjust with screws 8 and 2

1. Loosen screws 3 &4.

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2. Adjust the beam in the transverse direction by loosening screw 8 and then tightening screw 2 each ¼ turn.

3. Take Reference and alignment data and continue to adjust until the transverse error is within 2.5 mm of zero

4. If you need to adjust the collimator back toward the front of the scanner, loosen screw 2 and tighten screw 8 (old style collimator – new style has a spring plunger in place of screw 8).

5. Alignment Verification

A. If the brass alignment aperture is on the collimator, remove it.

B. Move the scan arm source detector to the center of the transverse and longitudinal axes.

C. Place the film jig on the detector as in step 1-C.

D. Insert a piece of film into the holder (large number "57" on film should face up and metal strip should be towards the scanner column)

E. Take an alignment film by clicking Picture button on the Alignment Aid Main screen.

F. Follow the directions on the film developer for developing the film (move the lever to 'L', insert the film, move lever to 'P', remove film, wait 20 seconds, peel apart).

G. Examine the alignment photo.

The box on the circuit board mask (from the film holder) should be entirely visible in the image on the film, if it is not, verify table level and realign the source.

Note: The box may not be centered exactly on the image as the position of the box on the film jig may not correspond to the exact location of the detector elements in the detector. As long as the entire box is visible and the Beam Wobble test (performed in the next section) passes, the source / detector is aligned.

1. The length and width of the beam image on the film should not be greater than 63.8 mm and 12.3mm respectively.

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2. Label the film with the system number, the date, and label each exposure’s location. Coat the film using the chemical sponge supplied with the film. Save this film and include it with the rest of the installation paperwork.

H. Remove the film holder from the detector

6. Beam Wobble Test

A. Perform Procedure DXAP2011 enCORE Beam Wobble Procedure.

7. Completing Required Testing

A. Refer to the Prodigy Service manual for additional tests to be performed or for installations proceed to document DXAP2003 Prodigy Installation Test Procedures.

GENERATED RECORDS Alignment Photo

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QUALITY SYSTEM DOCUMENT Page 1 of 3 It is the responsibility of the user to verify this document originated from the controlled master and is the active revision prior to use. This document contains confidential or proprietary information of GE Lunar. Neither the document nor the information therein is to be reproduced, distributed, used or disclosed, either in whole or in part, except as specifically authorized by GE Lunar.

DOC. ID: DXAP2003 REVISION: H DATE: 8/13/01 WRITTEN BY: Jeff Franz

MANUFACTURING PROCEDURES

GE Medical SystemsLUNAR

g

APPROVED ON CO: 7012

TITLE: Prodigy Installation Test Procedures

PURPOSE This procedure details the tests required to be run on a PRODIGY system upon its installation at a customer's site or when service requires.

APPLICATION

This procedure applies to all personnel installing or servicing a PRODIGY. SAFETY PRECAUTIONS The X-ray generator produces beam of ionizing radiation. The technician should take precautions to avoid exposing any part of their body to the beam. ASSOCIATED MATERIALS DXAP2000 PRODIGY Installation Procedure DXAP2001 PRODIGY Source-Detector Alignment Procedure DXAP2002 PRODIGY Primary Calibration Procedure DXAP2007 PRODIGY Hacksaw Test DXQC2022 PRODIGY Aluminum Spine Phantom Scan Procedure DEFINITIONS None. PROCEDURES These test procedures shall be performed following the assembly of the PRODIGY scanner according to procedure DXAP2000

1. CALIBRATION / SOFTWARE SETUP

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A. Perform the Primary Calibration according to Procedure DXAP2002 at this time.

B. Software / PC Installation Verification

I. Setup the Printer, Default, and Reference Data options as appropriate. Refer to the Operator's Manual.

I. Check the QA standard batch number on the bottom of the QA

standard. The fifth number in the serial number is the batch number – it will be a 1 or a 2.

II. Go to Tools/UserOptions/ Systems tab and verify that the batch

number matches that found on the QA standard.

C. Daily Quality Assurance tests

I. From the Main Menu, press F5 or click on the Quality Assurance to run a system calibration. Run three (3) calibrations.

II. Verify that all QA tests pass.

III. Leave the QA (calibration printouts) with the customer.

2. HACKSAW TEST

A. Perform the PRODIGY Hacksaw Test according to Procedure DXAP2007 at

this time. 3. PHANTOM SCANS NOTE: Before running any patient or phantom scans, three (3) daily QA’s (secondary calibrations) must be in the QA database for accurate results. If only one QA has been run from the system software (before the Alignment Verification), two (2) more need to be run.

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A. Scan the Encapsulated Lunar spine phantom scans according to the

Procedure DXQC2022. B. When setting up the phantom scan, verify the Patient Positioning Laser and

the Laser On light operate properly.

C. Acquire 3 Phantom scans

D. Average the results from the 3 analyzed scans, and verify that the mean is within 2or 3% of the expected value for the phantom. Record the average results of the scans and the expected result on the Install Report (DXAP2004).

NOTE: Follow the analysis instructions included with the Aluminum Spine Phantom. If not analyzed properly, the results may deviate from the expected value.

4. TEST COMPLETION

A. Perform 3 additional Daily QA (secondary calibrations) and insure all tests pass.

B. Print the QA Trend Reports (2 - 3mA and Misc.) by clicking on QA/QA Trend

Reports/Print.

C. Print the High mA Trend Report and the Misc. Trend Report.

NOTE: The software must be in Service Mode to print the QA Trend Reports.

D. Verify that the number of QA Repeats is set to 1 (QA/Settings – QA Repeats = 1).

GENERATED RECORDS 2 QA Trend Reports Alignment Verification Results 3 Aluminum Spine Phantom Results

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DOC. ID: DXAP2004 REVISION: S DATE: 8/13/01 WRITTEN BY: Jeff Franz

MANUFACTURING PROCEDURES

GE Medical SystemsLUNAR

g

APPROVED ON CO: 7012

TITLE: Prodigy Installation Check Sheet

ASSOCIATED MATERIALS DXAP2000 – PRODIGY Installation Work Instructions DXAP2003 – PRODIGY Installation Test Procedures

CHECK LIST

SYSTEM IDENTIFICATION SYSTEM NUMBER: _________________________ SCAN TABLE SERIAL NUMBER _________________________ INSTALL DATE: _________________________ IF CUSTOMER DATA ON THE DELIVERY RECIEPT IS INCOMPLETE / INCORRECT FILL IN BELOW FACILITY:__________________________________________________________________________ ADDRESS:___________________________________________________________________________________________________________________________________________________________ CITY:__________________________________STATE/COUNTRY:_________________ZIP:________ CONTACT:______________________________ PHYSICIAN:________________________________ PHONE #:__________________________________ FAX #:__________________________________ HOST PC MODEL :___________________________S/N:____________________________________ PRINTER TYPE:_____________________________________________________________________ SOFTWARE VERSION:____________________

TEST EQUIPMENT USED NONE

SETUP and TESTING

A √√ indicates a step has been completed satisfactorily, NA indicates not applicable.

All Items on Pick List present ......................................................................................................... _____

Verify 20A Dedicated Outlet ............................................................................................................ _____

Room passes criteria for Isolation or Isolation Transformer is present .................................................. _____

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Verify system alignment.................................................................................................................. _____ Verify motion control....................................................................................................................... _____

Beam Wobble Test Performed and Passed....................................................................................... _____

Verify Limit Switch Positions ........................................................................................................... _____

Hacksaw Test Performed ................................................................................................................ _____

6 QA Tests Performed .................................................................................................................... _____

Verify All Compliance Labels are correct and present......................................................................... _____

FDA Form 2579 Completed / Filed (USA ONLY)................................................................................ _____

Aluminum Phantom Scan Results

Phantom S/N____________

L2-L4 BMD

% Fat

1

2

3

Average (sum/3)

Expected Value N/A

% Difference ((ave-expected) / expected * 100) N/A

+/- 3% for Encapsulated Phantom

+/- 2% for Water Bath Phantom

(Circle One)

PASS

N/A

REPORTS PRESENT

A √√ indicates a step has been completed satisfactorily, NA indicates not applicable.

Picklist .......................................................................................................................................... _____

Alignment Photo (single exposure)................................................................................................... _____

Beam Wobble Test Results............................................................................................................. _____

QA Trend reports (High and Misc.)................................................................................................... _____

Phantom Scan Printouts (include Ancillary results)............................................................................ _____

FDA Form 2579 (Blue Copy) (USA ONLY)........................................................................................ _____

Signed (Customer) Delivery Receipt ................................................................................................._____ Installer CARES Dispatch # ______________ INSTALLER _____________________/____________________ DATE ___/___/___

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PURPOSE

This procedure specifies the methods used to install external options for a DPX-Seriesor Prodigy system.

APPLICA TION

SAFETY PRECAUTIONSNone.

ASSOCIA TED MA TERIALS

None.

DEFINITIONS

None.

PROCEDURES

This hardware facilitates two important external safety options:

1.

2.

External emergency stop switch.External indicator for x-ray generation

UNCON1'ROll£D DOCUMEN1'

Verity latest Revision

Betore Usmg

QUALITY SYSTEM DOCUMENT Page 1 of 6

This document contains confidential or proprietary information of Lunar Corp. Neither the document nor the information therein Is to be reproduced, distributed,used or disclosed, either In whole or In part, except as specIfically authorized by Lunar Corp.

This document applies toward the installation of external options for all DPX-Series or

Prodigy systems.

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QUALITY SYSTEM DOCUMENT Page 2 of 6 This document contains confidential or proprietary information of Lunar Corp. Neither the document nor the information therein is to be reproduced, distributed, used

or disclosed, either in whole or in part, except as specifically authorized by Lunar Corp.

External Options Wiring

E-StopJumper

Line INNeutral IN

Line OUTNeutral OUT

11

A2

14 12

A2 A1

11 14 12

A2 A2 A1

LineRelay

NeutralRelay

F11 F12

External E-Stop Switch

LED LED

Gnd OUT

Gnd IN

E-StopCable

Figure 1

1. EXTERNAL EMERGENCY STOP OPTION

A. The e-stop jumper must be removed and an external e-stop switch is installed as shown in Figure 1. The external e-stop must be a normally closed dry contact switch rated for 26 VDC or greater and 1 amp or greater. Without an external emergency stop, the e-stop jumper (see Figure 1) must be inserted.

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2. EXTERNAL INDICATOR OPTION

A. An external power source must be supplied by the customer. The voltage and current are limited by the ratings of the line and neutral fuses provided. Fuses with lower amperage rating for a specific application may be provided by the customer. The ratings of the factory fuses are 3.15A/250V. The external power source must be connected to the Line and Neutral IN terminal blocks. The external indicator must be connected to the Line and Neutral OUT terminal blocks (see Figure 1). An earth terminal block is provided for connecting power supply and indicator grounds if necessary. F11 and F12 are fuses for the Line IN and Neutral IN respectively. If an external indicator is not used, no external power source is needed.

3. INSTALLATION PROCEDURE

A. Fasten the DIN rail to the PEM nuts located on the pan using 2 8-32 X 3/8" screws each with a #8 flat washer and lock washer (see Figures 2-5 for locations). Some older systems may not have the PEM nuts on the pan. In that case, drill two holes in the pan 5" apart as in Figure 2. Ensure that holes do not interfere with mainframe strut located under the electronics mounting plate.

26V PS

+5/+12/-12 V PS

Terminal Blocks

Terminal Block

Isolation Transformer

AGSBoard

AC ENTRANCE

5 "

Term

inal

Blo

ck

FuseLabel

SSRELAY

Figure 2 (DPX-IQ)

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Figure 3 (Prodigy systems < DF+12000)

Terminal Block

Isolation Transformer

FuseLabel

SSRELAY

AC Inlet

External OptionsTerminal Block

Figure 4 (DPX-NT systems < NT+72000)

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Terminal Block

FuseLabel

Relay

AC Inlet

External OptionsTerminal Block

RelayFilter

STRAIN RELIEF

Figure 5

(DPX-NT systems > NT+72000 and Prodigy systems > DF+12000)

B. For systems with 3 holes for strain relief (DPX-NT and Prodigy) use supplied strain relief fittings (4549). For IQ systems with 3/4" access holes, cut the 4 5/8" piece of grommet (1029) in half. Place a small amount of cyanoacrylate based glue on the inside edge of the grommets and insert around the edge of the 3/4” diameter holes.

C. For DPX-NT systems greater than NT+72000 and Prodigy systems greater

than DF+12000, connect the external options relay cable to CSBC J26. Route the cable along side the existing relay cable.

For all other systems, connect the cable assembly (3682) to the solid state x-ray relay located on the pan. Connect the black wire terminal ring to the (-) terminal on the solid state relay and the red wire terminal ring to the (+) terminal. Route the cable from the solid state relay to the external options terminal block.

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D. For systems using a CSBC or FOINK, remove jumper J15 or J3 from the CSBC or FOINK, respectively. Connect the remaining external e-stop cable to J15 or J27, respectively. Route the cable along side the existing relay cable.

For systems using OINK, Revision E or higher, connect remaining external e-stop cable (4339) to J27. Route the cable from the OINK board to the external options terminal block, wire tying the cable to existing wires along the way. Insert the cable ends into the terminal block (see Figure 5) if necessary. Remove jumper JB1 from the OINK board.

For systems using OINK, revision 02C, locate the gray wire coming from J17 of the OINK board. Cut the gray wire approximately two inches from the OINK board connector. Strip 1/4" of insulation from both ends of the gray wire. Cut the J connector off of cable 4339 and strip 1/4" of insulation from the black and red wires. Cut the 1 1/2" piece of heat shrink tubing (5190) in half and slide it onto the red and black wires. Solder the red wire end to a gray wire end, twisting the two wires together before soldering; repeat for the black wire end and the remaining gray wire end. Place the heat shrink over the exposed wire.

E. Place the External options label (3680) on the pan. The label should be placed in close proximity to the terminal block. Leave the data boxes on the label blank if the information is unknown.

F. Secure all wires in place with wire-ties.

G. Start a QA or spine scan. Verify that the both LEDs (one near each relay) illuminate in unison with the x-ray indicator on the scanner’s display panel. Verify that scanner stops when external e-stop is engaged or e-stop jumper (see Figure 1) is removed.

GENERATED RECORDS

None.

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QUALITY SYSTEM DOCUMENT Page 1 of 25 It is the responsibility of the user to verify this document originated from the controlled master and is the active revision prior to use. This document contains confidential or proprietary information of GE Lunar. Neither the document nor the information therein is to be reproduced, distributed, used or disclosed, either in whole or in part, except as specifically authorized by GE Lunar.

DOC. ID: DXPC2000 REVISION: AP DATE: 12/19/02 WRITTEN BY: Jerry Mandt

MANUFACTURING PROCEDURES

GE Medical SystemsLUNAR

g

APPROVED ON CO: L10527

TITLE: enCORE PC Configuration Procedure for WinNT

PURPOSE This procedure is used to setup a PC and software for Drive Imaging enCORE (aka Prodigy, DPX-NT, and DPX-MD+).

APPLICATION This procedure applies to all PC’s and software. Execute appropriate procedure steps based on the model of PC to be configured and the sites requested by the sales order.

SAFETY PRECAUTIONS Disconnect the line cord from the Computer before opening the enclosure.

Precautions should be taken (e.g. wearing of grounding straps, etc.), when necessary, to ensure a static-free environment exists when handling and installing PCB’s and other static sensitive devices.

ASSOCIATED MATERIALS None.

DEFINITIONS None.

PROCEDURES Section 1. SETTING UP THE PC (Standard configuration)

Loading Application Software

A. Windows NT 4.0 Installation (not required for preloaded systems)

Section A of this procedure is used to: 1) Setup the Disk for imaging or, 2) When replacing the system drive, only if attempts to recover a corrupt system have failed. The steps described here will erase all data on the system partition. The data will not be recoverable. If the system has an

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LS120 installed, set the “first boot device “ to the CD-ROM following Section S, and skip to step # 10. (To determine if the system has an LS120- LS120 drives have the Emergency Eject holes on them.)

1. Restart the computer with the Windows NT 4.0 Workstation Setup Disk 1 in the floppy drive.

2. Wait for the computer to load Setup Disk 1. 3. Insert Windows NT 4.0 Workstation Setup Disk 2 when prompted and press

<Enter>. 4. Press <Enter> to install NT. 5. Press <Enter> to detect disk controllers. 6. Insert Windows NT 4.0 Workstation Setup Disk 3 when prompted and press <Enter> 7. Verify setup detects IDE and SCSI disk controllers. 8. Press <Enter> to continue setup. 9. Insert Windows NT 4.0 Workstation CD when prompted and press <Enter> to

continue. 10. Press <Page Down> 7 times to scroll through license agreement. 11. Press <F8> to accept agreement and continue. 12. Press <n> to install a new version of NT. 13. Verify hardware and software components:

• Computer: Standard PC • Display: Auto Detect • Keyboard: XT,AT, or enhanced keyboard (83-104 keys) • Keyboard layout: US • Pointing device: Microsoft mouse port mouse

14. Press <Enter> to continue. 15. If a partition exists, use the up/down arrow keys to highlight it. 16. Press <d> to delete the partition.

Note: Deleting a partition will permanently destroy all data on the partition. Make sure any data has been backed up so that it can be later restored. This action is irreversible.

17. Press <Enter> to continue deleting the system partition. 18. Press <L> to verify deleting the partition. 19. Press <C> to create a new partition. 20. Use the Backspace key to clear the Default Partition size and enter 3999 as the

Partition size. Press <Enter> to accept the partition size. Note: This is the maximum size for an installation partition. OTC will resize it according to our specs.

21. Press <Enter> to install the Partition. 22. Select the desired file system using up/down keys. Select “NTFS File System” and

press <Enter> to continue. 23. Wait for partition to be formatted. 24. Location for installation of NT files should be \WINNT. Press <Enter> to continue. 25. You should perform an exhaustive disk test if the software is being reloaded

because of a disk problem (i.e. hard disk failures). Press <Enter> to perform the exhaustive test. Otherwise, press <ESC> to perform a quick disk test.

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26. Wait for the disk test to complete. 27. Wait for the file copy to complete. 28. Remove the diskette/CD from the drives and press <Enter> to restart the computer. 29. Wait for the restart to complete. 30. Insert Windows NT 4.0 Workstation CD into the drive and press <OK>. 31. Press <Next> to gather information required for install. 32. Select “Typical” installation and press <Next>. 33. Type in GE Lunar Corporation for both name and organization and press <Next>. 34. Type in the Product ID from the Certificate of Authenticity and press <Next>. 35. Type in ENCORE in the Computer Name and press <Enter> 36. Do not enter a Password. Press <Next> to continue. 37. Select “Yes” to create an Emergency Repair Disk and press <Enter> to continue.

(For Imaging purposes, select NO) 38. Select “Install the most common components” and press <Next>. 39. Press <Next> to install Windows Networking. 40. Select “Do not connect this computer to a network at this time”. 41. Select <Next> to continue. 42. Select <Finish> to complete the installation. 43. Select the appropriate time zone. (Central Time(US and Canada) 44. Verify correct time and date. 45. Press <Close> to continue. 46. Press <OK> to configure the display settings. 47. Note: The video card detected may not match the current configuration. Video

drivers should be loaded according to the steps specified later in this section. 48. Press <OK> to continue setup. 49. If you answered Yes to step #37, Label a Floppy disk, insert it in the drive and press

<Next> to continue. 50. Remove the CD and/or diskette and Restart the computer when prompted. If the

system has an LS120 installed, press [F2] on boot up, enter setup and reset the first boot device to the Floppy Drive. Refer to Section S for the correct configuration.

51. Wait for the computer to restart. 52. Log in as Administrator. (No Password) and close the Welcome Window.

Setting up the Network Note: Before proceeding, copy both the I386 and SP6 folders to the HDD. This will facilitate the rest of the process. Refer to steps 5 & 7 of section U for help.

1. Insert the latest “Technical Data” CD supplied by OTC, into the CD-ROM drive. 2. Use WindowsNT Explorer (click Start, Programs, WindowsNT Explorer) to create

a Folder called C:\NT_Drivers. Explore the “Technical Data” CD and Navigate to Drivers\MBA and open either the Ca810E folder or the 815 folder depending on which type of System board is in the PC. For the 845 board go to Drivers\NIC\486x. The System board type is displayed during the POST Boot. Copy the Networking folder to the folder you just created on the Hard Disk. Right click on the Networking folder. From the drop down menu, click on copy. Move the cursor to the Hard Disk

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(C☺ and Right click on (C:\NT_Drivers). From the drop down menu, click on Paste. Close Explorer. Right click on the Networking folder and rename it to Network. Close Explorer.

3. Right click on the Network Neighborhood Icon. Select Properties. 4. When prompted to install Networking, (Make sure you’re connected to the Network),

select Yes. 5. Verify “Wired to the Network” is checked and click Next. 6. Click on “Select from List” and then “Have Disk” 7. When prompted for the drivers, type C:\NT_Drivers\Network and click OK 8. From the Select OEM option box, Select OK 9. From the Network Adapters box, click Next 10. From the Network Protocols box, check both TCP\IP and Net BEUI and click Next 11. From the Network Services box, click Next 12. Click Next to install the selected components. 13. Setup will need to copy some files from the WinNT CD. When prompted, enter

C:\Winnt\I386 for the location of the files and press Continue. 14. At the TCP\IP Setup screen, click Yes to use DHCP. 15. Click Next at the “Show Bindings for” screen. 16. Click Next to start the Network. 17. From the Computer Name and Workgroup box, click Next and then Finish. 18. Restart when prompted. 19. Uncheck the “show this screen on the next login”… Close the Welcome screen. 20. Double click on the Network Neighborhood Icon to verify the connection. You

should see other members of the Workgroup such as: • Entire Network • Npprod • ENCORE • S5y5f4 • Symposium

21.Exit the Network Neighborhood

Windows NT 4.0 Service Pack Installation – 128 Bit Security (not required for preloaded systems)

Prodigy/NT versions 2.16 and older use SP4 • Insert the “NT 4.0 Service Pack 4(SP4) CD” into the CD-ROM drive. • Wait for autorun to display Lunar CD Browser menu. • Select Install NT 4.0 Service Pack 4 (40-bit). • Select “Accept at the License Agreement” screen • Deselect “Backup files necessary to uninstall” • Press <Install> to continue. • Wait for setup to complete. • Press <Restart> when prompted.

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• Verify WinNT blue boot screen states “Microsoft Windows NT Version 4.0 Build 1381: Service Pack 4”

• Log in as Administrator. • A Message box may be displayed indicating Year 2000 issues with the

detected software components. (These issues will be resolved later in this procedure)

• Press <No> to the Y2K.TXT file question. • Remove the NT 4.0 Service Pack 4(SP4) CD from the drive. Prodigy/NT versions 2.17 and newer use SP6 (installing from CD)

• Insert the “EnCore product CD” into the CD-ROM drive. • Exit the CD browser when Autorun launches. • Navigate to NT4Sp6a\update and run update.exe • Select “Accept at the License Agreement” screen. • Deselect “Backup files necessary to uninstall” • Press <Install> to continue. • When the files are copied, the system will reboot. • Verify WinNT blue boot screen states “Microsoft Windows NT

Version 4.0 Build 1381: Service Pack 6” Prodigy/NT versions 2.17 and newer use SP6 (installing from HD) • Click Start, Run and type in C:\SP6\Update\Update.exe • Select “Accept at the License Agreement” screen • Deselect “Backup files necessary to uninstall” • Press <Install> to continue. • When the files are copied, the system will reboot. • Verify WinNT blue boot screen states “Microsoft Windows NT

Version 4.0 Build 1381: Service Pack 6” • Log in as Administrator.

Remove the EnCore product CD from the drive.

Video Driver Installation (not required for preloaded systems)

For Granite Microsystems computers (STB NITRO 3D) • Insert the diskette labeled “STB NITRO 3D Video Drivers WINNT” into

the floppy drive. • Use “Start|Settings|Control Panel|Display” to load the drivers. • Select the Settings property page. • Press <Display Type>. • Press <Change>. • Press <Have Disk>. • Enter “A:\” for “Copy manufactures files from:” and press <OK>. • Select “STB Systems, Inc. Nitro 3D (ViRGE/GX)” and press <OK>

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• Continue to common section below.

For Omni-Tech computers (Matrox G200 Video Card) • Insert the “Technical Data” CD supplied by OTC, into the CD-ROM

drive. • From My Computer, double click on the CD-ROM drive and run setup

from \Drivers\Vdc\G200-400\WinNT40. • Select the Settings property page. • Press <Display Type>. • Press <Change>. • Press <Have Disk>. • Enter “X:\Drivers\Vdc\G200\Winnt40” for “Copy manufactures files

from:” and press <OK>. (substitute X: for the appropriate CD-ROM drive designation)

For Omni-Tech computers (on Board Video) • Insert the latest “Technical Data” CD supplied by OTC, into the CD-

ROM drive. • Explorer the CD and navigate to \Drivers\MBA and open either the

Ca810E the 815 or the 845ge folder depending on which type of System board is in the PC. The System board type is displayed during the POST Boot. Open Video\WNT4 and copy the Graphics folder to C:\NT_Drivers. Rename this folder to Video.

• Open the Video folder and run Setup.exe. • At the Welcome Screen, Press Next. • At the License Agreement Screen, Press Yes. • At the Destination Location Screen, Press Next. • Remove the “Technical Data” CD • Restart the computer when prompted by clicking on Finish. • Go to Internet Explorer Section.

Common (this section applies to Video cards)

• Press <Yes> at the warning message. • Wait for the file copy to complete and press <OK> when prompted. • Remove the diskette or CD from the drive. • Press <Close> to exit the Display Type dialog. • Press <Close> to exit the Display Properties dialog. • Press <Yes> to restart the computer. • Wait for the computer to restart. • Log in as Administrator. • Press <OK> when prompted that a new display adapter has been

added. • Check the “Don’t show this message again” box and cancel the

Registration. (Do this on the second re-boot).

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• Configure Settings to: Small fonts, 65536 colors and 1024x768 (for 17” monitors) and 800x600 (for 15” monitors).

• Press <Test> to verify the settings will work properly. • Press <OK> to view the test pattern. • Press <Yes> if the pattern was displayed properly. • Press <OK> to close the Display Properties dialog.

Internet Explorer 4.01 SP2 Installation Note 1. Use SP1 for v2.16 and earlier Note 2. If your setting up a system using enCORE v3.0 and newer, use the enCORE application CD to install IE4. Use Explorer to view the contents of the enCORE CD and run ie4setup.exe from the IE4 folder. Note 3. For systems with enCORE v6.7 use the enCORE application CD to install IE6. Skip down to Press <Next> at welcome dialog.

• Insert “EnCore OS Supplement v2” into CD-ROM drive. • Wait for autorun to display Lunar CD Browser menu. • Select Install Internet Explorer 4.01. • Press <Next> at welcome dialog. • Select “Accept license agreement” • Press <Next> to continue. • Select “Standard Installation” • Press <Next> to continue. • Select “Yes” to install Desktop Update. • Press <Next> to continue. • Select “United States” for the language. • Press <Next> to continue. • Use default folder location (C:\Program Files\Plus!\Microsoft

Internet). • Press <Next> to continue. • Wait for setup to complete. • Press <OK> to continue. • Press <OK> to restart the computer. • Logon as Administrator. • Wait for configuration to complete. • Next steps are for IE4 only • Close the IE4 quick tour by clicking on the “X” in the upper right hand

corner. • Use Start/Settings/Control Panel Double click on Display. Change

the Wall Paper to None by selecting the Background Tab. • Select the Web Tab. • Deselect “View my Active Desktop as a web page” • Press <Apply> and <OK> • Remove the CD

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B. Audio Installation • Insert the latest “Technical Data” CD supplied by OTC, into the CD-

ROM drive. • Explorer the CD and navigate to \Drivers\MBA and open either the

Ca810E the 815 or the 845ge folder depending on which type of System board is in the PC. The System board type is displayed during the POST Boot. Run the Setup program. At the Welcome screen, click Next to begin the selected process.

• When the Setup is complete, click Finish and reboot when prompted. • In the Microsoft Internet Explorer Welcome Dialog box, Deselect

“Show this next time you log in” and click Close. • Remove the CD

C. Configure Additional Users (optional) • If you want to setup new users, logon as the Administrator • Use “Start|Programs|Administrative Tools (Common)| User Manager” • From main menu select |User|New User • Enter the new user’s name in Username with a password. • Keep default settings so

- User will change password at next logon - User cannot change password - Password never expires - Account is enabled - Member of ordinary users

• <OK> • Logout. • Login to confirm new user account.

D. Configure Desktop Settings (repeat for each user) 1. Login as desired user. 2. Right mouse click on an open space in the Task Bar and select

Properties to configure Task Bar properties – Clear the Check mark from Always on top option. Press Apply and OK.

3. Use “Start|Settings|Control Panel|Display” to configure display. 4. Click the Settings tab to configure the following settings. Small fonts,

65536 colors and 1024x768 (for 17” monitors) and 800x600 (for 15” monitors). If no changes were necessary, proceed to step # 7

5. Press Test to ensure video adapter can handle this resolution. 6. At the “Did you see the Bitmap properly? Prompt, press Yes if the

bitmap appears. (Select Yes before 5 second timeout resets the display settings to the previous values)

7. Press OK to set the selections and exit the display setup. 8. Double Click on the Regional Settings Icon. Select the Date Tab and Set

the short date format to mm/dd/yyyy. Click Apply and OK

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9. Double Click the System Icon. Select the Startup|Shutdown Tab and Change the boot timeout from 30 seconds to 10 seconds in “Show List for 10 seconds” Click Apply.

10. Select the Performance Tab, Click Change in the Virtual Memory box and change the Paging File size of drive “C” in both the Initial size and the Max size accordingly; Set both to 150mb for systems with 64mb physical memory. Set both to 300mb for systems with128mb physical memory.

Click Set, OK, Close and reboot when prompted. 11. Close the Control Panel

E. Install (PCI) Modem Card and Drivers (Installed on all PC’s)

Note: The 3Com PCI modem is installed using a default address and a default IRQ. These should not be changed unless you are certain there will be no conflicts. 1. Un plug the power cord, wait 5 seconds and install the Modem in

slot 3 for Prodigy and either slot 2 or 3 for Dpx-NT/MD+. 2. Plug in the power cord and boot the PC. 3. Insert the latest “Technical Data” CD supplied by OTC, into the

CD-ROM drive. Explorer the CD and navigate to Drivers\MDI\3com\Setup.exe for the 810e/815 boards or \Drivers\MDI\LPDF56K92\WinNT\Setup.exe for the 845 board. The System board type is displayed during the POST Boot.

4. Run the Setup program. 5. Press Next, Next 6. Double click on Modem from Control Panel. 7. Click Dialing Properties and set the Area code to 608

To test the Modem, use Phone Dialer found in Accessories. Prior to creating the “in-house “ image (this is the image of the operating system setup prior to Lunar Application software installation) verify/perform the following-

1. Empty the Recycle Bin. 2. Verify there are no errors from the last boot in the Event viewer (Start,

Programs, Administrative Tools, Event viewer)

F. Printer Setup: HP930c

• Copy the appropriate Print Driver folder from the Printer folder on the current enCORE application CD to C:\NT_Drivers using Explorer.

• Run the Setup program from within the folder you just copied over (i.e. “HP930c\Disk1\Setup”)

• Click Install Printer Software • Click Next at the Welcome screen

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• At the Select Port screen, Verify LPT1 is the selected port and click Next.

• At the Congratulations screen, press Done. • Close Explorer. • Set the Printer Properties by using Start|Settings|Printers, right-

mouse click and select Properties. Select the Scheduling tab and set the Priority to 50, enable Spool print documents so program finishes printing faster, and enable Start printing immediately. Click OK to apply the changes and close the printer properties.

Removing HP IO • Click Start, Programs, HP DeskJet 930C Series v2.3, HP DeskJet

930C Series v2.3 Toolbox. • Click the printer icon in the upper left corner of the Title bar. • Click About. • While holding down the CTRL key, double-click on the printer in the

middle of the screen. • A Configuration Dialog box should appear with name of your printer

highlighted. Make sure this dialog box is active (the Title bar will be highlighted, if not click anywhere in the box to make it active). Press ENTER, then click Continue. The Configuration screen should open.

• Click the “Remove HP IO” button and confirm the removal. This may take a few seconds. Control returns when the “Remove HP IO” button is grayed out.

• Deselect 4 items: Automatic two sided printing module handling, Status client, Photo tray handling and Low on ink warning.

• Close the Configuration screen. • Open the Services Icon in the Control Panel. Scroll down and

highlight the Printer Status Server. Press the Startup button and Disable the service and press OK. Next press the Stop Button and Stop the service. Close the Services program and exit the control Panel.

• Reboot the PC

G. Printer Setup: HP940c

3. Note: Use version 4.3 of the 930c print driver. HP IO is not installed with this version. H. Printer Setup: Kodak 1200

• Insert the Driver Software CD • At the Welcome screen, press Next. • At the License Agreement Screen, press Yes. • From the Select Components screen, press Next.

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• Press Next at the Destination Location dialog box. • Press Next to start coping files. • Press Next at the Printer Port screen. (The default is LPT1) • Accept the printer name by pressing Next. • Set it up as the default printer and press Next. • Press Next at the Copy Files screen. • Press the Cartridges Tab from the Properties dialog box. • Press Install the Left cartridge and then select either Black

cartridge 1 for Gray scale printing or select Install cartridge 1 for Color printing and press New.

• Press Install Right cartridge, press Install cartridge 2 and press New.

• An alignment page will print out, use it to align the cartridges according to the on screen prompt and press OK.

• Press OK to close the Properties dialog box. • Wait for the setup to complete, uncheck the “View the Readme file”

and press Finish. • The PC will reboot automatically. Remove the CD.

I. Printer Setup: HP Business Inkjet 2250 Note: The very first time the

printer is turned on it can take up to 15 minutes to initialize and warm up. Also when an ink cartridge is changed it can take a while to prime. • Insert the Driver Software CD • Select Install Print Driver • Press OK to install the software in English • Press Next at the Welcome screen and Accept the License

Agreement • With “Connect directly to this computer” selected, press Next • With Parallel selected and LPT1 highlighted, press Next • Select Custom setup and press Next • From the Components dialog box, deselect HP Business Inkjet 2250

PCL 5C driver and press Next • Press Install from the Installation Settings dialog box • Close the HP Installer help box and press Exit twice. • To Print a test page go to the properties page of the printer by

selecting Start/Settings/Printers and right clicking on the printer. Sealevel Serial Adapter – Driver Installation (PRODIGY ONLY)

Drivers for the SeaLevel serial adapter must be installed before the board can be installed. The PCI Plug and Play feature requires the manufacturers information files (*.inf) are installed first. • Login as Administrator.

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• Insert the Latest released Prodigy “Setup CD” into CD-ROM drive. • Wait for autorun to display Lunar CD Browser menu. • Select Install Serial Drivers from the Main Menu and press OK. • Close the “Advanced Ports Windows NT Configuration Utility”

screen • Exit the Prodigy Installation Menu.

J. Sealevel Serial Adapter Hardware Installation (PRODIGY ONLY) Check Jumper settings on board: J1A = On for P,P,T and off for L, L J1B = All jumpers off J1C = DIV2 on and off for DIV1 and DIV4

• Shut down computer using “Start|Shut down computer”. • Wait for prompt when safe to turn off the computer. • Pull power cord out. • Remove PC cover. • Remove blank panel from PCI slot 2 to make room for SeaLevel serial

card. Note: Slots are numbered from the inside to the outside with the inside slot being number one.

• Install the Sealevel PCI card into slot 2. (For PC’s with a Video card, use slot 4)

• Secure the card into slot using the screw removed from blank panel. • Insert power cord and turn power on. • Wait for the system to restart and login as Administrator. • From the Control Panel, (Start/Settings/Control Panel) double click

on Advanced Ports. Click on the appropriate COM port (COM3 if no modem is installed, COM4 if a modem is installed and COM2 on the 845as described below)

• Verify settings are Model 7102, PCI bus Port, and Valid Port is checked.

Note: If there is a modem in the PC, the SeaLevel card will be configured as

COM4. For the PC P/N 41122 (845 bd.), the SeaLevel card is installed as COM2

K. Application Software Installation

1. Login as Administrator. 2. Obtain the latest Production Master Application Software CD and insert it in the

CD-ROM drive. 3. Wait for autorun to display Lunar CD Browser menu. 4. Select product installation from Lunar CD Browser menu. 5. Press Yes to accept the EnCore Software License Agreement.

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6. The Default is Install required components. Accept this and press Next to continue.

7. The installation is in several parts. Restart the system (if prompted) after each component is installed.

8. If prompted at the Acrobat Reader screen, press Next, otherwise skip to step12. 9. Press Accept at the License Agreement screen. 10. Press <Next> at Install Location screen. (accept default location) 11. At the Thank You screen, press OK. 12. Press <Next > at the Product Welcome screen. 13. Press <Next> at Information screen. 14. Press <Next> at the User Information Screen. 15. Press <Next> at Install Location screen. (accept default location) 16. Leave the System# and Feature Code fields blank and press <Next> to continue. 17. Press <Next> to “Start Copying Files” 18. Press <Next> at Install Location screen. (accept default location) 19. Press <Next> to “Start Copying Files” 20. Select Yes “I want to Launch Prodigy/DPX-NT (or MD+)” now and Press Finish.

As the Software opens, you will receive a few dialog boxes. (If a Modem is installed, you’ll also get an invalid Com3 error- see the note below.)

• If Tele-D is enabled in the feature code and Outlook is not yet configured, you will be prompted with an error message from Outlook stating there is no default mail client followed by an application error message stating “Enhanced messaging API is not available. These message boxes will appear on application startup until Outlook is properly configured.

• Click OK to create a New QA Database • Click OK at “ No Primary Calibration file is specified” (Prodigy only) • Click OK at “ No Database Connections” • Set the archive path to the appropriate drive letter, if not A: and

Click OK to accept the New Database NOTE: (PRODIGY ONLY) By default the COM port in the software is [3]. If a modem is installed in the PC, follow the steps below to set the COM port to [4]. NOTE: Version 5.00 and newer auto detect which port the SeaLevel card is on and set the software accordingly. The 845 board has only one on-board Communication port so the SeaLevel card will be setup as Comm2.

From the Main Menu, Click [F6] Options, Select User Options. Check the Service box and enter the Service Mode using “Smile” as the password for version 1.3 and earlier and “Award” for version 2.1 and later, and click OK. From the Main Menu, Click [F6] Options, and select service options. Click on the Serial Tab. If a change is necessary, drop down the selection menu by clicking on the button to the right of Port and change the port accordingly. Click OK to close the Service Options box.

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Remove the CD. Exit the Software only. Do not shut down the PC at this time.

Installing Optional Interface Cards and Drives

Note: If both a modem and a Network adapter are being installed, the Audio must be disabled in the BIOS. Turn on the PC and enter the BIOS by pressing F2 when prompted. Cursor to Advanced, select Peripherals and disable the Audio by highlighting Audio and pressing enter. Select Disable and press Enter. Exit by pressing F10, save the configuration and let the PC boot. You must also remove the Audio drivers by double clicking on Multimedia from the Control Panel. Click on the Devices Tab, and click the + by the Audio Devices. Highlight the Driver and click Remove. Click Yes to the warning message. This will eliminate the service failure message displayed during NT startup.

L. Install (PCI) Modem Card and Drivers (after the SeaLevel card is installed)

Note: The 3Com PCI modem is installed using a default address and a default IRQ. These should not be changed unless you are certain there will be no conflicts. A. Prodigy Systems

1. Go to Start/Settings/Control Panel, open “Advanced Ports. Highlight Com3.Under Adapter information, click the Com Port drop down menu button and select Com4. Click OK and Yes to Restart. 2. From the Control Panel, double click Ports and click Add. 3. Select Com3 as the Com Port number. 4. Change the Base I/O Port Address to 03E8 by clicking on the down arrow to the right of the Address box. 5. Change the IRQ to 4 by clicking on the down arrow to the right of the Address box. Click OK and Don’t Restart Now. Click Close. 6. Close the Control Panel, click Start, Shutdown and Shutdown the PC. 7. Unplug the power cord, wait 5 seconds and Install the Modem in slot 3 8. Plug in the power cord, power up the PC. 9. Wait for the PC to boot and go to Start/Settings/Control Panel, open “Ports”. Highlight Com3, click Settings then Advanced and Change the Base I/O Port Address to Default by clicking on the down arrow to the right of the Address box. 10. Change the IRQ to Default by clicking on the down arrow to the right of the Address box. Click OK and Don’t Restart Now. Click OK and Close. Close the Control Panel. 11. Insert the latest Technical Data CD supplied by OTC. Navigate to \Drivers\MDI\3com\Setup.exe for the 810 and 185 board. .

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Navigate to \Drivers\MDI\LPDF56K92\WinNT\Setup.exe for the 845 board. Press Install to start the installation. 12. Press Yes to Restart. 13. Go to Start/Settings/Control Panel, open “Advanced Ports. Highlight Com3. Click Remove Port, and Yes to “Are you sure”. Click OK and Yes to restart. 14. Close the Control Panel and remove the CD.

B. Dpx-NT (MD+) Systems 1. Un plug the power cord, wait 5 seconds and install the Modem in

slot 2 or 3 2. Plug in the power cord and boot the PC. 3. Insert the latest Technical Data CD supplied by OTC Navigate to

\Drivers\MDI\3com\Setup.exe for the 810 and 185 board. . Navigate to \Drivers\MDI\LPDF56K92\WinNT\Setup.exe for the 845 board.

4. Press Install to start the installation. 5. Press Yes to Restart. 6. Remove the CD.

• Prodigy only: Use Advanced Ports from the Control Panel and Verify

COM4 is a valid PCI port. Press Cancel to avoid the reboot prompt. Prodigy only: When opening Prodigy you will receive an error message stating a “750 Serial card has been detected” or incorrect Serial Port configuration. This is because the software is by default, set to Com3. You must go into Service Options and set the Port to Com4. NOTE: Version 5.00 and newer auto detect which port the SeaLevel card is on and set the software accordingly. The 845 board has only one on-board Communication port so the SeaLevel card will be setup as Comm2. • To test the Modem, use Phone Dialer found in Accessories.

M. NIC Installation. (Network Interface Card) Note: Omni Tech PC Models # OEM-1000D01810E, 8100D05815 and the OEM-3124D00 Halyron ESG(845ge board) come with integrated Networking.

If the LAN needs to be re-installed, the Drivers can be located on the OTC Technical Data CD (Version 1.63 or newer for the 815 board) in either the “Drivers\MBA\CA810E\Networking” folder or the “Drivers\MBA\815\Networking” folder.

• Point the installation to the above folder and from the list of drivers select the “8255x-Based PCI Ethernet Adapter 10/100. This is the preferred driver although any of the drivers in the list will work just fine. Follow the prompts to complete the installation. Note: You must re-install the Service Pack. Refer to the Service Pack installation of Section A.

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• For the 845ge board navigate to \Drivers\NIC\846x\Setup.exe. From the list of drivers select the Intel Pro 100 Family adapter. Follow the instructions on Setting up the Network in Section A

SCSI Installation N. Adapter Installation

1. Insert the supplied driver CD which is packaged with the Jaz drive. If “Autorun” starts, cancel it.

2. Go to Start/Settings/Control Panel, and double click on SCSI Adapters. Click the Drivers Tab and then click on ADD.

3. Click on Have Disk. When prompted for the location of the drivers, type “X:\Drivers\NT40\Jaz Jet 2930C” (replace “X” with your CD-ROM drive letter), and press OK to continue.

4. From the “Select driver” box, press OK. 5. Enter the same path as in step #3 and press OK. 6. Restart the PC when prompted. You will receive an error message on

boot up stating, “One or more drivers…failed to start. This is ok. 7. Remove the CD and shut down the PC. (Start, Shutdown, OK) 8. Un plug the power cord, wait 5 seconds and install the SCSI adapter in

PCI slot one (the slot closest to the Power Supply). 9. Install the drive in one of the 3.5” drive bays with the provided

hardware. Connect the SCSI cable from the drive to the adapter card and connect the power cable to the drive.

10. Plug in the power cord and power up the PC. Zip Drive Installation O. Refer to LUPC0001 (Verify latest Rev) for the drive installation procedure. Zip Driver Installation

The drivers can be found on the CD that OmniTech supplies with all their PC's, (Technical Data CD, the path is \Drivers\Tad\Iomega) v1.60 (dated 12/8/00) or newer. Run Ioware.exe. 2. At the Welcome screen, press Next 3. Press Yes to the License agreement. 4. Accept the default Destination Location by pressing Next. 5. Click Close to end Setup. 6. Shut down when prompted and install the drive. 7. When re-started the installation will resume. Answer Yes if the Zip drive is

displayed. 8. Close the congratulations box and verify the operation of the drive. 9. The setup will ask if you’re installing a USB drive, Answer NO.

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The drive will be installed with the next Physical drive letter. To change the drive letter to the last Logical letter, 1. Go to Start\Programs\Administrative Tools\Disk Administrator

(you’ll need to have a disk in the Zip drive to do this) 2. Right click on the second partition of Disk 0, (E:) and select Assign

Drive Letter. Change the Drive Designation to any unused letter. Press OK and accept the Change.

3. Right click on Drive D: and select Assign Drive Letter. Set the Drive Designation to E: Press OK and accept the Change.

4. Right click on the Drive you changed in step 2 and change the drive to D:

5. Reboot the PC. This procedure can be used to switch any drive letters except A:

P. Installing Outlook 2000 1. Insert the CD and wait for Autorun to launch. 2. At the Welcome screen, enter the CD key code and press Enter. 3. Accept the Agreement and press Next. 4. Click Customize 5. From the Install Location dialog box, press Next. 6. From the Updating Windows dialog box, click the drop down

menu arrow and select “Do not upgrade Microsoft I.E”. and press Next.

7. From the Selecting Features window, click on the yellow 1 by Symantec Fax starter, select Not available and press Install Now.

8. Wait for the files to be copied and restart when prompted. Refer to DXAP2030 for Setup Procedures.

Installing Outlook 2002 Note: Version >6.0 If the system you are installing Outlook 2002 on does not have the minimum required level of functionality, you will be prompted to update the Core System, Data Access Components and Web Browsing. If prompted to update, proceed with step 2, if not skip to step 4.

1. Insert the CD and wait for Autorun to launch. 2. If prompted to update, press Next. 3. From System Files Update Setup” drop down the selection menu

and select “Do Not upgrade I.E and press Next. Reboot when prompted

4. Enter the Product key (found on the back of the case), and press Next.

5. Accept the Agreement and press Install. 6. From the Type of Installation screen, click Next. 7. Begin the installation by clicking Install. 8. When the install is complete, press OK, remove the CD and reboot

the system.

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Refer to DXAP2030 for Setup Procedures.

Q. Remote Access Service Installation 1. Right click on the Network Neighborhood Icon and select

Properties. 2. Click the Services Tab and press Add. 3. Select Remote Access Service and press OK. 4. Insert the WinNT CD when prompted (if Autorun Launches, close it)

and press Continue. 5. From the “add RAS device” dialog box, verify the modem (56k fax

internal PCI) is selected and press OK. 6. From Remote Access Setup, press continue. 7. Close the Network dialog box and press No when prompted to

restart and Re-install the appropriate Service Pack. Refer to the Service Pack installation of Section A.

R. Configure WinFax Pro (Modem software)

• Configuring Windows NT to use the fax modem.

1. In Windows NT Control Panel, (Start, Settings, Control Panel) double click the “Modems” icon. Verify that the 56K Fax INT” modem is present. If the “Modem is not present you will get the prompt asking if you want to install one. Follow the appropriate steps above.

2. Click on “Dialing Properties” and enter 608 as the area code. (The customer will have to change this later) Press Close, Close and Exit the Control Panel.

• Installing WinFax PRO

1. Insert the WinFax installation CD and wait for autorun to display WinFax Pro Menu Screen.

2. Click Install. 3. At the Welcome Screen, press Next. 4. At the License Agreement Screen, press Yes. 5. Click Next at the User Information Screen. 6. Click Next at the Destination Folder Screen. 7. The Default Setup Type is Typical, Click Next. 8. Click Next at the Select Program folder. 9. Click Next at the Start Copying Files screen. 10. At the File Copy Complete screen, click Finish to reboot. 11. Click Next at the WinFax Pro Setup (CSID) screen. (Leave the

fields blank)

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12. At the “Modems and Other Fax Devices” screen, select the “56K FAX modem” from the modem and device list if it is not already selected and click Next.

13. Click Next to Test the Modem. 14. The results of the Test list the class and speed of the Modem.

Click Next to continue. 15. With “Yes” selected in the “Enable Controller” dialog box,

press Next. 16. From the Configure E-Mail screen, click Next. 17. Press Cancel at the Online Registration screen and Yes to

“Are You Sure?” click Next. 18. From the Ready to Configure System screen, press Finish. 19. Answer NO to the Readme question. 20. Cancel the Live Update. 21. Select Yes to the Message Manager. 22. From the Phone book autolink screen, check Outlook 2000

and press OK. 23. Press Next at the Phone Book Name 24. Click on the Set Information button. 25. Click on the “Use Business Related Information” Radio button

(if not already selected) and press OK. 26. Press Finish 27. After rebooting Windows NT and logging back on, verify that the

fax icon appears on the status bar. 28. The WinFax Installation program has a bug in it. To correct it,

Click Start, then Settings, and Printers. Right click on WinFax. Select Document Defaults from the Drop down list. Click the Advanced Tab. In the WinFax Document Settings dialog box, click on Print Quality. Click on Low Resolution Fax in the Change “Print Quality” Setting Box and click OK. Right click on WinFax and Select Document Defaults again. Change the Resolution back to Normal by clicking the Advanced Tab. In the WinFax Document Settings dialog box, click on Print Quality. Click on Normal Resolution Fax in the Change “Print Quality” Setting Box and click OK.

29. Close the Printers Dialog box and remove the CD

• Configuring AutoMentor 1. Subject to change.) Verify that you select WinFax as one of the available printers from within the application and that you can fax a patient report to Lunar service or some other destination. AutoMentor is not enabled at this time.

S. Setting the CD-ROM as the first Boot Device.

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• On boot up, Press [F2] to enter Setup. • Press the → key 4 times to enter the Boot Menu. • Press the ↓ key 7 times to the first Boot Device and press <Enter>.

Cursor down to the CD-ROM and press <Enter>. Insert the Bootable CD (i.e. Windows NT Workstation) and press [F10] to save and exit setup. Windows Setup will initiate on boot up. Press <Enter> at the Welcome screen, press enter at the “mass storage detection” screen, and skip to step # 10 of section A.

Default Boot Sequence

• FDD • HDD • CD-ROM

T. PCI card slot assignment – (for PC’s with a Video Card)

• PCI Slot 1: Adaptec SCSI Card (Optional) • PCI Slot 2: Virge Nitro 3D Video Card • PCI Slot 3: EtherLink Network Card (optional) • PCI Slot 4: SeaLevel Serial Card

PCI card slot assignment – (for PC’s with on board Video and NIC)

• PCI Slot 1: Adaptec SCSI Card (Optional) • PCI Slot 2: SeaLevel Serial Card • PCI Slot 3: Modem • PCI Slot 4:

U. Creating the Image

Prior to creating the Final image (this is the image of the operating system setup with the Lunar Application software installed) verify/perform the following-

1. Empty the Recycle Bin. 2. Verify there are no errors from the last boot in the Event viewer (Start, Programs,

Administrative Tools, Event viewer) 3. Verify DMA is Enabled. DMA Check is a small utility (NT only) used to

enable/disable the DMA of the HDD. There is a copy on the network at R&D\Software(32Bit)\Utilities. Copy the file DMA check to a floppy disk, insert the disk in the PC being configured and using WindowsNT Explorer (click Start, Programs, WindowsNT Explorer), switch to the a: drive and double click on DMA check. Place a in both Enabled boxes. Press OK, then Yes to the Warning Message. Press OK at the Finished prompt.

4. For SP4 - Insert the EnCore OS Supplement v2 CD. (Exit the CD browser when Autorun launches). Using WindowsNT Explorer, copy the i386 folder from the NT4SP4a folder located on the EnCore OS Supplement v2 CD onto the Hard Disk. Rename this folder to SP4.

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5. For SP6 – Insert the EnCore product CD. (Exit the CD browser when Autorun launches). Using WindowsNT Explorer, copy the NT4SP6a folder from the EnCore product CD onto the Hard Disk. Rename this folder to SP6.

6. Using WindowsNT Explorer, create a folder on the Hard Disk called NT_Drivers and copy the following folders into it. Explore the “Technical Data” CD and Navigate to Drivers\MBA and open either the Ca810E folder or the 815 folder depending on which type of System board is in the PC. The System board type is displayed during the POST Boot. For the 845 board go to Drivers\NIC\846x. Copy the Networking folder to the folder you just created on the Hard Disk. Right click on the Networking folder. From the drop down menu, click on copy. Move the cursor to the Hard Disk (C:) and Right click on (C:\NT_Drivers). From the drop down menu, click on Paste. Right click on the Networking folder and rename it to Network. Close Explorer.

7. Using WindowsNT Explorer, copy the i386 folder from the WinNT 4.0 CD into the WinNT folder on the Hard Disk.

8. Insert the latest Production Master Application Software CD and install Dklite. After the installation is complete, defrag the HD by going to Start, Programs, Dklite.

10. All OmniTech PC models with on board LAN have networking installed. This means that you will receive an error message every time the system is booted (and every 6 minutes) if it is not connected to the Network. To avoid this message disable the DHCP Client. Go to “Start,Settings,Control Panel”. Double click on the Services Icon. Highlight “DHCP Client” and click on Startup. Click in the disabled radio button and press OK. Note: Prior to connecting a system to a LAN, the service must be re-enabled.

11. Refer to LUPC0006 to create the Image.

Section 2. Duplicating Product Software If the appropriate version of software is already loaded on the local hard disk, proceed with Step B. This can be verified by locating the appropriate folder named \product_X_XX_XXX on local hard drive; where product_X_XX_XXX is the product software version to be duplicated. A. Creating Master Software on Duplicator PC.

• Insert product “Master Setup CD” into CD-ROM drive. • Wait for Lunar CD Browser to start. • Exit Lunar CD Browser. • Create folder named \product_X_XX_XXX on local hard drive. • Copy entire contents of product “Master Setup CD” into folder created

above. • Wait for copy to complete and remove the “Master Setup CD” from the

CD-ROM drive.

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• Start Adaptec Easy CD Creator. • Select “Data CD” and press <Next> • Select entire contents of the folder product_X_XX_XXX. • Press <Add Now> to add the selected files and sub-folders to the CD

layout. Press <Next> • Select “Do not perform test” and press <Next> • Select “Create CD later” and press <Finish> • Change CD label to product_X_XX_XXX using menu command

“File|CD Layout Properties” • Save CD layout as product_X_XX_XXX.cl3 using menu command

“File|Save As” B. Create Product CD.

• Insert blank CD into CD-ROM drive. • Start Adaptec Easy CD Creator. • Press <Cancel> from the CD Creator Wizard Dialog. • Open CD layout product_X_XX_XXX.cl3 using menu command

“File|Open CD Layout”. • Validate CD layout using menu command “File|Validate Layout” • If errors are encountered, go to Step A of this section to restore

required files. • Start recording process using menu command “File|Create CD” • Select option to: Test and create CD • Select <OK> to start recording. • Verify CD was created successfully.

Section 3. Configuring Application Software

• Check Sales Order for System Number and Application Sites. • Get S/W Order Form FM03-4. • Start Configurator. • Enter System Number and select the options per the sales order. • Do not enable any application that does not have okay to ship status

unless approved by Regulatory Affairs. Review table below for latest status. If Regulatory Affairs approval is granted, then enable the application and add special “Investigation” label on software.

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Application DPX-MD+

Release Status

DPX-NT Release Status

Prodigy Pro Release Status

Prodigy Oracle Release Status

Prodigy Vision Release Status

AP Spine Standard Standard Standard Standard Standard Femur Standard Standard Standard Standard Standard Total Body Optional

(Full-size Only)

Optional (Full-size Only)

Optional (Full-size Only)

Standard (Full-size Only)

Standard (Full-size Only)

Dual Femur Optional Optional Standard Standard Standard Advanced Hip Assessment

Optional Optional Optional Optional Standard

Pediatric Spine

Optional Optional Optional Optional Optional

Pediatric Total Body

Optional Optional Optional Optional Optional

Forearm Optional Optional Optional Optional Standard oneVision Optional Optional Optional Optional Standard Orthopedic Optional Optional Optional Optional Optional Lateral Optional Optional Optional Standard Standard HL7 Optional Optional Optional Optional Optional Multiuser DB Optional Optional Optional Optional Optional Teledensitometry

Optional Optional Optional Optional Standard

Dicom Optional Optional Optional Optional Standard Lateral View Not Available Not Available Optional Standard Standard Business Reports (encore composer)

Optional Optional Optional Standard Standard

Physician Reports (encore composer)

Optional Optional Optional Standard Standard

Animal body Not Available Not Available Optional. Need warning label 40122

Optional. Need warning label 40122

Optional. Need warning label 40122

All other Software Options

Internal use only

Internal use only

Internal use only

Internal use only

Internal use only

Note: Compact systems do not require a configuration feature code. They are configured in the field at the time of install using Service Options.

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Serial and System numbers: First Scanner Number First System Number DPX-NT (DPX-MD+) NTA Beta 70001 NT+70000 NTA Production 70101 NT+70000 NTB Beta 72001 NT+72000 NTB Production 72101 NT+72100 NTC Beta 73001 NT+73000 NTC Production 73101 NT+73100 DPX-NT 180 (DPX-MD+ 180) NTB-180 Beta 90001 NT-90101 NTB-180 Production NTC-180 Beta 91001 NT-91000 NTC-180 Production 91101 NT-91100 Prodigy Prodigy 1 Beta 60001 DF+10001 Prodigy 1 Production 60101 DF+10001 Prodigy 2 Beta 62001 DF+12000 Prodigy 2 Production 62101 DF+12100 Prodigy 3 Beta 63001 DF+13001 Prodigy 3 Production 63101 DF+13101 Prodigy 4 Beta 64001 DF+14001 Prodigy 4 Production 64101 DF+14101 Prodigy Compact Prodigy 3 Compact Beta 80001 DF-80001 Prodigy 3 Compact Production 80101 DF-80101 Prodigy 4 Compact Beta 81001 DF-81001 Prodigy 4 Compact Production 81101 DF-81101 Note, in each system number, the plus or minus symbol is used to denote total body option availability. This has been for historical purposes. Configurator is not conditionally tied to this convention. Application DPX-MD+ Release

Status DPX-NT Release Status

Prodigy Release Status

Production Release 6.70.021 on NT hardware

6.70.021 6.70.021

Limited release for user tests at early adopter sites

None None None

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• Configurator program automatically generates the feature code. • Select required printer, using menu command “File|Printer Setup”, to

Epson FX-880. • Print three labels. • Remove labels and place one on the S/W Production Form in the

designated area. Place the second label on the CD Diskette sleeve. Place the third label on the PC Form.

• Using Copy/Paste (Ctrl C/Ctrl V), take feature code from configuration and paste into Filemaker DB program.

• Fill out paperwork associated with software order form.

Note: Internal QA/Production software should be configured as System Number 00002 with all sites enabled.

GENERATED RECORDS DXPC2001 DPX Fan PC Configuration Form FM03-4 Software Order Form

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QUALITY SYSTEM DOCUMENT Page 1 of 7 It is the responsibility of the user to verify this document originated from the controlled master and is the active revision prior to use. This document contains confidential or proprietary information of GE Lunar. Neither the document nor the information therein is to be reproduced, distributed, used or disclosed, either in whole or in part, except as specifically authorized by GE Lunar.

DOC. ID: DXAP2011 REVISION: B DATE: 8/13/01 WRITTEN BY: Jeff Franz

MANUFACTURING PROCEDURES

GE Medical SystemsLUNAR

g

APPROVED ON CO: 7012

TITLE: enCORE Beam Wobble Procedure

PURPOSE

This procedure describes the steps necessary to perform the Beam Wobble scan for Prodigy or DPX-NT systems.

APPLICATION

This procedure applies to all employees performing installation or service of Prodigy scanners with version 2.26 or greater software.

SAFETY PRECAUTIONS The x-ray generator produces a beam of ionizing radiation. The technician should take precautions to avoid exposing any part of their body to the x-ray beam.

ASSOCIATED MATERIALS DXAP2000 Prodigy Installation Instructions DXAP2004 Prodigy Installation Report DXAP200x Prodigy Source Detector Alignment DEFINITIONS None. PROCEDURES

1. LIMIT TO LIMIT TEST

A. Remove the scanners table top (if not already removed).

B. Enter the Service Mode of the Fan Software Options / User Options Service – Enter Password (Smile sw ver 1.0 – 2.05 or Award ver 2.10 +)

C. Insure that the Front, Head and Foot Panels are minimally hanging on the scanner frame.

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D. Run the limit to limit test with the configure box checked to establish the scan window.

1. Select Tools / Diagnostics / Scanner Motion

2. Click on the configure box – there will be a check mark in the box when it is selected.

3. Click on Start in the limit to limit box

4. While the Limit to Limit test is running be sure to listen and look for anything that is binding or impeding the mechanics of the scanner. In particular: - Tube head and shutter assembly must clear tabletop and carriage bracket bolts. - Shutter assembly wiring should be correct and wire tied so they do not catch on anything - Especially watch for binding while the scan arm is moving to home

position. The Molex connector of the collimator assembly may hang up, causing the scanner to jerk when moving off of the limit switch.

- Also verify that the arm slot cover is not slipping out of the guides when the scan arm is at the head and foot of the scan table.

- The height of the High Voltage cable trough must be low enough so that the High Voltage cables do not get hung up on the stepper motor drive (CENTENT) but not so low as to cause the high voltage cables to bind.

- Insure that all moving parts are traveling to their limits without restriction or impediment.

5. Check the limit to limit values against the table below.

Direction Steps Tolerance Longitudinal 19875 +/- 25 Transverse 12475 +/- 25

6. If any of the limit to limit distances are out of spec perform the steps below, if values pass go to step 7.

I. If the front panel is on the scanner, remove it. II. Go to Tools\Diagnostics\Scanner Motion

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III. Click on Move to Home - Place the "Home Position" jig in the home corner. Verify the hole in the collimator lines up with the hole in the jig as in figure 1.

FIGURE 1: Home position Jig – verifying home position IV. If home position does not match the Home position Jig, adjust the limit

switch positions using the service software as illustrated in step A below. If home position does not need to be adjusted, proceed to step V.

a. Go to Tools/Diagnostics/Limit Switch Adjustment b. Follow the on Screen prompts – DO NOT EDIT THE DEFAULT

VALUES c. If limit switch positions are altered a Limit to Limit test (see VI

below) must be run with the configure box checked to recalibrate the scanners range of motion.

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V. Replace all exterior scan table panels (see DXAP2000 – Figure 9 for panel placement and fastener selection), with the exception of the arm shrouds.

VI. In the Service software, go to Tools / Diagnostics / Scanner

Motion. Check the configure box and then Run the Limit to Limit Test by clicking on the Start button for Limit to Limit verify that the Step Values for longitudinal and transverse are within tolerance.

NOTE: If the scan window is altered in any way (limit switch moved – scanner is reassembled) the Limit to Limit Test must be run with the configure box checked.

7. Run a second limit to limit test with approximately 250 lbs (150kg) of weight on the table top, check for binding in the arm slot cover at this time.

8. Click on Close

2. PERFORM BEAM WOBBLE A. Select Measure – use the patient Phantom Spine – if the patient does not

exist enter the following information B. Enter patient information for Spine Phantom (if it has already been entered,

go to step E). C. Enter the Directory by selecting the Directory F4 button from the main

screen. D. Open the New Patient dialog by clicking the New button on the Directory

toolbar.

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Figure 2: New Patient Dialogue Box with Spine Phantom Patient information entered in the appropriate fields.

E. Enter the patient information as illustrated in figure 2. F. Click OK to close the dialog and save the new patient information.

G. Double-click the Spine Phantom patient in the Patient List to enter the New

Measurement screen.

H. Click on Beam Wobble in the Site box (it will be highlighted blue when it is selected)

I. Verify that the table top is off and there are no objects positioned around the

table that might impede scanner motion

J. Click on position in the tool bar at the top of the screen

K. Allow the scanner to acquire reference counts in the center of the table – make sure the alignment aperture is not present.

L. When prompted, place the alignment aperture on to the collimator, then click

OK.

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M. When the scanner returns home, click on Start and allow the Beam Wobble scan to run. It will take approximately 6 minutes.

N. When the test is complete it will be analyze it by clicking on the analyze

button on the tool bar.

O. Select the Spine Phantom patient from the list and then double click on the appropriate Beam Wobble file.

a. Verify that the TEST RESULTS – Test Outcome = Pass b. If the test does not pass, look at the image, it should look

essentially like a random distribution of gray.

c. White areas with an outline indicate areas where alignment problems exist.

Figure 2: Failing Beam Wobble Image – Alignment Aid showed that the beam was biased toward detector 1 (head) – Alignment aid showed good alignment in all other areas of the scan table. Lowering the front foot corner with the glide improved the alignment in Alignment Aid.

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d. To correct these areas of mis-alignment: 1. Verify table level 2. Verify that nothing is impeding scanner motion 3. Verify count rate / alignment in Signal Monitor or Alignment Aid

in the problem areas of the scan table. 4. Adjust Table level / alignment as necessary. 5. Re-Run the Beam Wobble test 6. If the Beam Wobble test fails a second time perform

DXAP2006 Prodigy Dial Indicator Alignment Verification Procedure.

NOTE: If anything passes through the beam during this test, IT WILL FAIL.

P. When passing results have been achieved, print the results by clicking on the Print button on the toolbar.

Q. When the Beam Wobble has been completed return to DXAP2001 step 7-A

to complete the alignment.

GENERATED RECORDS

None.

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QUALITY SYSTEM DOCUMENT Page 1 of 20 It is the responsibility of the user to verify this document originated from the controlled master and is the active revision prior to use. This document contains confidential or proprietary information of GE Lunar. Neither the document nor the information therein is to be reproduced, distributed, used or disclosed, either in whole or in part, except as specifically authorized by GE Lunar.

DOC. ID: DXAP2030 REVISION: D DATE: 3/1/02 WRITTEN BY: Tom Bergman

MANUFACTURING PROCEDURES

GE Medical SystemsLUNAR

g

APPROVED ON CO: L10181

TITLE: Teledensitometry Configuration Procedure

PURPOSE This procedure is used to setup the Teledensitometry kit and any optional software for Prodigy and DPX-NT.

APPLICATION This procedure applies to certain LUNAR validated PC’s and software (Granite Microsystems where applicable and OmniTech computers). It can be used as a guideline for installing hardware and software in other computers, however there is no guarantee that this procedure will in fact work with other PCs. Execute appropriate procedural steps based on the model of PC to be configured and the number of additional Teledensitometry options ordered by the site.

• If the hardware setup is to be performed on a system running Windows XP, follow section 6. Note: After setting up Outlook, the customer should be strongly encouraged to archive their mail on a weekly basis. This backup should place the archived file on the D: drive. In the event a customer uses the recovery image and they have not archived their mail to the D: drive, it will be lost including all contacts.

• If the hardware setup is to be performed on a Prodigy system, follow section 1.

• If the hardware setup is to be performed on a DPX-NT system, follow section 2.

• If the hardware is already setup and you need to install Microsoft Outlook 2000 software, follow section 3.

• If the hardware is already setup and you need to install WinFax Pro software, follow section 4.

• If the hardware is already setup and you need to install WinFax Pro software and/or other Teledensitometry options, follow section 4 (SETTING UP WINFAX PRO SOFTWARE) and section 5 (SETTING UP TELEDENSITOMETRY SOFTWARE).

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SAFETY PRECAUTIONS None.

ASSOCIATED MATERIALS LUNAR enCORE™ Operator’s Manual P/N 8543 LUNAR Ambassador HL7 Interface Configuration Manual P/N 8596 LUNAR DICOM Operator’s Manual P/N 17663 Setting up a Multi-User Database DXPC2000 DPX-Fan/DPX-NT PC Configuration Procedure

DEFINITIONS None.

PROCEDURES Section 1. INSTALLING HARDWARE IN PCs CONNECTED TO PRODIGY A. Installing Optional Interface Cards

Note: OmniTech computers require some alterations prior to installing interface cards. If both a modem and a Network adapter are being installed, the Audio must be disabled in the BIOS. Turn on the PC and enter the BIOS by pressing F2 when prompted. Cursor to Advanced, select Peripherals and disable the Audio by highlighting Audio and pressing Enter. Select Disable and press Enter. Exit by pressing F10, save the configuration and let the PC boot. Remove the Audio drivers by double clicking on Multimedia from the Control Panel. Click on the Devices Tab, and click the + by the Audio Devices. Highlight the Driver and click Remove. Click Yes to the warning message. This will eliminate the service failure message displayed during NT startup. There are two possible types of modems that can be in the Teledensitometry kit, ISA or PCI. If there are jumpers on the card it is an ISA, if not it is a PCI card. For ISA modems go to step B, for PCI modems go to step C.

B. Install (ISA) Modem Card and Drivers

All new systems are purchased with the SeaLevel card installed as Com3. If a modem is being added, follow the steps below:

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1. Jumper the modem for Com3, IRQ 4 and install it in the outermost ISA slot.

2. Login in as Administrator and install the modem drivers by going to the Control Panel and double clicking on the Modem Icon. Check the “Don’t detect my Modem “ box and click Next.

i. Omni-Tech Systems

1. Insert the CD supplied from OTC (Technical Information

and Data) and click Have Disk. Switch to the CD drive and click Browse. Double click on Drivers|MDI|USRB. Click Open then OK. In the Manufacturers box, click U.S. Robotics Access Corp. and select the 56k fax internal modem and click Next. Select Com3 as the port to install the drivers on and click Next. Click Finish and from the Modem Properties Dialog box, click Dialing Properties and enter the Area Code. Click OK, Close.

3. Prodigy only: Use Advanced Ports from the Control Panel and change the second Com3 port to COM4. Click OK and let the computer reboot.

4. Prodigy only: Use Advanced Ports again and Verify COM4 is a valid PCI port. Select Cancel to avoid the reboot prompt.

5. Prodigy only: When opening the Prodigy program you will receive an error message stating a “750 Serial card has been detected” or incorrect Serial Port configuration. This is because the software is by default, set to Com3. You must go into Service Options and set the Port to Com4.

6. To test the Modem, use Phone Dialer found in Programs\Accessories. 7. To load WinFax Pro software go to Section 3.

C. Install (PCI) Modem Card and Drivers Note: The 3Com PCI modem is installed using a default address and a default IRQ. These should not be changed unless you are certain there will be no conflicts. For PCs in the field that already have Microsoft Windows-NT Service pack 6 installed, Go to Step 1. For PCs with Service Pack 4 go to step 3.

1. Remove the SeaLevel Serial card drivers by going to

Start|Settings|Control Panel. Select Add/Remove Programs, Highlight SUD Setup and then select Add/Remove. After the serial drivers have been removed close the Add/Remove Programs screen. Restart the PC.

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2. Go to Start|Settings|Control Panel, select Ports. Highlight Com 3 and select Delete. Exit Control Panel and power down PC.

3. Install the Modem in slot 3.

i. Omni-Tech Systems 1. Insert the supplied OTC Technical Data CD (ver 1.41 or >)

and wait for the “Autorun” to launch. Exit the autorun program on the CD. Click Start|Run and Browse. Navigate to \Drivers\MDI\3com and run Setup. Reboot when prompted. After a successful reboot you may enter setup (BIOS) and re-enable the Audio (if disabled in step 2).

2. If you have removed the SeaLevel drivers in step C.1. you must reinstall them now by inserting the Prodigy CD in the CDROM drive, wait for autorun to launch and select option #1-Serial drivers version XXX.

4. Prodigy only: Use Advanced Ports from the Control Panel and Verify

COM4 is a valid PCI port. Press Cancel to avoid the reboot prompt. 5. Prodigy only: When opening Prodigy you will receive an error

message stating a “750 Serial card has been detected” or incorrect Serial Port configuration. This is because the software is by default, set to Com3. You must go into Service Options and set the Port to Com4. i. Go to Tools|User Options|Systems tab. ii. Check the Service checkbox and enter in the appropriate

password. Select OK. iii. Go to Tools|Service Options|Serial tab. iv. Change the Com port to 4. v. Select OK to close. vi. Exit Prodigy software.

6. To test the Modem, use Phone Dialer found in Accessories. 7. To Load WinFax Pro software proceed to Section 3.

D. Adding a Network Interface Card (NIC) to an existing system

NOTE: There must be a functional network connection in order for the installation of Windows Networking to be tested. Consult with the customer’s IS department, or Network person, to determine the protocols and services required. If a workgroup (no server) is used then the specific TCP/IP address will have to be known before installing the NIC. If a DHCP Server is used, then a Computer Name and Domain must be known before installing the NIC. The Computer Name must match the one given by the Network Administrator. To change the Computer Name, Right click on Network Neighborhood from the Desktop. Answer “No” to setting up the network

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now. Go to Properties| Identification and Change. Edit the Computer Name. Do not reboot the computer now, rather shutdown and install the NIC. Follow the appropriate steps below. DICOM and HL7 features require TCP/IP protocol and default Windows Networking services to function properly. There are two types of NIC’s. A PCI NIC and an on-board NIC. To install networking with the on-board NIC go to step 2.

1. Insert the PCI NIC in PCI slot #3. 2. Connect the network cable. 3. Power-up the computer and login as the Administrator.

i. For Omnitech computers with a PCI NIC: 1. Copy the 3C90X folder (found on the OTC Technical Data

CD version 1.41 or greater) from \drivers\NIC\3com\ to the root on the C drive before starting the network install.

2. Insert the Windows NT CD in to the CD ROM drive. If the

autorun program starts, cancel out of it and leave the CD in the drive. You will need it in step 5 Win NT setup.

ii. For OmniTech computers with an on-board NIC:

1. Networking will already be installed on the PC. A DHCP Client will have been chosen but turned off to avoid the PC from trying to connect to a network every 6 minutes. To re-enable the DHCP Client go to Start|Settings|Control Panel. Select the Services icon by double clicking on it. Select DHCP Client and select Startup. Select the Automatic radio button and select OK. Select Start to start the service. Go to section 3.

4. Double-click the Network icon in the Control Panel and confirm the

installation of Windows Networking. If Windows Networking has not yet been set up you will receive a message that “Windows NT Networking is not installed. Do you want to install it now?” Select “Yes” and continue.

5. Select “Wired to the network” and press Next. 6. At the Network Setup Wizard screen, choose “Select from list”. 7. At the Select Network Adapter screen, choose “Have Disk”. 8. At the Insert Disk take the appropriate action based on the type of

Ethernet adapter. i. For a PCI NIC type c:\3c90x and select OK. ii. For an on-board NIC type c:\lan and select OK.

9. The OEM option screen should state `you have selected either the 3Com EtherLink PCI NIC or the Intel 82559 Fast Ethernet LAN on Motherboard. Select OK to continue.

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10. Select Next to continue at the Network Setup/Network Adapters screen. 11. At the Network Protocols screen, make sure TCP/IP Protocol is checked

and select Next to continue. 12. At the Network Services screen all options will be checked. Select Next

to continue. 13. Select Next to install the selected components. 14. At the Windows NT Setup screen it will state “Setup needs to copy some

Windows NT files.” Make sure that the Windows NT CD is in the CD ROM drive. If the autorun program starts, exit the autorun program and get back to the Windows NT Setup screen. Type: x:\i386 (where “x” is the drive designator of the CD ROM drive. Select Continue.

15. The TCP/IP Setup screen will appear. It will state that “If there is a DHCP server on your network TCP/IP can be configured… If you have a DHCP server, select Yes to continue. If not, select No and continue.

16. If you selected Yes, the Network Setup Wizard will start copying files from the Windows NT CD. If you selected No, you are then given the opportunity to input a specific IP address. This information will be provided by the IS personnel on site.

17. Select all services and then select Next. 18. Windows will now be ready to start the network. Select Next. 19. If a DHCP server has been chosen then the Install Wizard will ask for the

Computer Name, Workgroup and/or Domain. Make sure the Computer Name matches the one given on the network by IS personnel. It cannot be changed in this screen. Follow the onscreen directions and select Next.

20. Select Finish and Networking should be installed. 21. Remove the Microsoft Windows NT CD from the drive. 22. Click Yes to restart the computer to complete the network configuration. 23. Login as administrator. 24. Error messages may appear indicating failure of services during startup.

Dismiss these errors and continue with the following step. 25. Re-apply NT Service Pack 6 to update any files that were copied from the

NT 4.0 Workstation CD. Use Windows Explorer to look for Service Pack 6 on the C drive. If Service Pack 6 is on the C drive it will be in a folder called C:\SP6. If you do not find this folder, use the enCORE Operating System Supplement CD ROM disk provided with the Teledensitometry kit. Follow the instructions in step E to reapply Service Pack 6.

E. Windows NT 4.0 Service Pack 6 Installation – 40 Bit Security (not required for preloaded systems)

1. Insert the enCORE Operating System Supplement CD in the CD ROM drive. Wait for Autorun to launch and display the LUNAR browser menu

2. Select option 1 Install NT 4.0 SP6 - English. Service Pack 6 will be installed and the PC will restart automatically.

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Wait for the PC to boot up completely and remove the CD from the drive.

Section 2. INSTALLING HARDWARE IN PCs CONNECTED TO DPX-NT

A. Installing Optional Interface Cards

Note: OmniTech computers require some alterations prior to installing interface cards. If both a modem and a Network adapter are being installed, the Audio must be disabled in the BIOS. Turn on the PC and enter the BIOS by pressing F2 when prompted. Cursor to Advanced, select Peripherals and disable the Audio by highlighting Audio and pressing Enter. Select Disable and press Enter. Exit by pressing F10, save the configuration and let the PC boot. Remove the Audio drivers by double clicking on Multimedia from the Control Panel. Click on the Devices Tab, and click the + by the Audio Devices. Highlight the Driver and click Remove. Click Yes to the warning message. This will eliminate the service failure message displayed during NT startup. There are two possible types of modems that can be in the Teledensitometry kit, ISA or PCI. If there are jumpers on the card it is an ISA, if not it is a PCI card. For ISA modems go to step B, for PCI modems go to step C.

B. Install (ISA) Modem Card and Drivers

1. Jumper the modem for Com3, IRQ 4 and install it in the outermost ISA slot.

2. Login in as Administrator and install the modem drivers by going to the Control Panel and double clicking on the Modem Icon. Check the “Don’t detect my Modem “ box and click Next.

i. Omni-Tech Systems

1. Insert the CD supplied from OTC (Technical Information and

Data) and click Have Disk. Switch to the CD drive and click Browse. Double click on Drivers|MDI|USRB. Click Open then OK. In the Manufacturers box, click U.S. Robotics Access Corp. and select the 56k fax internal modem and click next. Select Com3 as the port to install the drivers on and click next. Click Finish and from the Modem Properties Dialog box, click Dialing Properties and enter the Area Code. Click OK, Close.

3. To test the Modem, use Phone Dialer found in Accessories.

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4. To Load WinFax Pro software go to Section 3.

C. Install (PCI) Modem Card and Drivers Note: The 3Com PCI modem is installed using a default address and a default IRQ. These should not be changed unless you are certain there will be no conflicts.

1. Install the Modem in slot 3 2. If both a modem and a Network adapter are being installed, follow the

directions above in Section 2. A. 3. Insert the supplied OTC Technical Data CD (ver 1.41 or >) and wait for

the “Autorun” to start. Click Exit in the lower Right hand corner. Select Start and then Run. Type in X:\Drivers\MDI\3com\Setup.exe. (Replace X: with your CD-ROM drive letter). Click OK.

4. Select Install to start the installation. 5. Select Yes to Restart. (On reboot enter setup and re-enable the Audio (if

disabled in step 2). 6. Remove the CD. 7. To Load WinFax Pro software go to Section 3.

D. Adding a Network Interface Card (NIC) to an existing system

There must be a functional network connection in order for the installation of Windows Networking to be tested. Consult with the customer’s IS department, or Network person, to determine the protocols and services required. If a workgroup (no server) is used then the specific TCP/IP address will have to be known before installing the NIC. If a DHCP Server is used, then a Computer Name and Domain must be known before installing the NIC. The Computer Name will have to be changed to match the one given by the Network Administrator. To change the Computer Name, Right click on Network Neighborhood from the Desktop. Answer No to setting up the network now. Go to Properties| Identification and Change. Edit the Computer Name. Do not reboot the computer now, rather shutdown and follow the appropriate steps below. DICOM and HL7 features require TCPIP protocol and default Windows Networking services to function properly. There are two types of NIC’s. A PCI NIC and an on-board NIC. To install networking with the on-board NIC go to step 2.

2. Insert the Ethernet adapter in PCI slot #3. 3. Connect the network cable. 4. Power-up the computer and login as the Administrator.

ii. For Omnitech computers with a PCI NIC: 1. Copy the 3C90X folder (found on the OTC Technical Data

CD version 1.41 or greater) from \drivers\NIC\3com\ to the root on the C drive before starting the network install.

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2. Insert the Windows NT CD in to the CD ROM drive. If the

autorun program starts, cancel out of it and leave the CD in the drive. You will need it in step 12 for Win NT setup.

iii. For OmniTech computers with an on-board NIC:

1. Networking will already be installed on the PC. A DHCP Client will have been chosen but turned off to avoid the PC from trying to connect to a network every 6 minutes. To re-enable the DHCP Client go to Start|Settings|Control Panel. Select the Services icon by double clicking on it. Select DHCP Client. Select the Automatic radio button and select OK. Select Start to start the service. Go to section 3.

5. Double-click the Network icon in the Control Panel and confirm the installation of Windows Networking. If Windows Networking has not yet been set up you will receive a message that “Windows NT Networking is not installed. Do you want to install it now?” Select Yes and continue.

6. Select Wired to the network and select Next. 7. At the Network Setup Wizard screen, choose “Select from list”. 8. At the Select Network Adapter screen, choose “Have Disk”.

a. At the Insert Disk take the appropriate action based on the type of Ethernet adapter. i. For a PCI NIC type c:\3c90x and select OK. ii. For an on-board NIC type c:\lan and select OK.

8. The OEM option screen should state `you have selected either the 3Com EtherLink PCI NIC or the Intel 82559 Fast Ethernet LAN on Motherboard. Select OK to continue.

9. Select Next to continue at the Network Setup/Network Adapters screen. 10. At the Network Protocols screen, make sure TCP/IP Protocol is checked

and select Next to continue. 11. At the Network Services screen all options will be checked. Select Next

to continue. 12. Select Next to install the selected components. 13. At the Windows NT Setup screen it will state “Setup needs to copy some

Windows NT files.” Make sure that the Windows NT CD is in the CD ROM drive. If the autorun program starts, exit the autorun program and get back to the Windows NT Setup screen. Type x:\i386 (where “x” is the drive designator of the CD ROM drive. Select Continue.

14. The TCP/IP Setup screen will appear. It will state that “If there is a DHCP server on your network TCP/IP can be configured… If you have a DHCP server, select Yes to continue. If not, select No and continue.

15. If you selected Yes, the Network Setup Wizard will start copying files from the Windows NT CD. If you selected No, you are then given the

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opportunity to input a specific IP address. This information will be provided by the IS personnel on site.

16. Select all services and then select Next. 17. Windows will now be ready to start the network. Select Next. 18. If a DHCP server has been chosen then the Install Wizard will ask for the

Computer Name, Workgroup and/or Domain. Make sure the Computer Name matches the one given on the network by IS personnel. It cannot be changed in this screen. Follow the onscreen directions and select Next.

19. Select Finish and Networking should be installed. 20. Remove the Microsoft Windows NT CD from the drive. 21. Select Yes to restart the computer to complete the network configuration. 22. Login as administrator. 23. Error messages may appear indicating failure of services during startup.

Dismiss these errors and continue with the following step. 24. Re-apply NT Service Pack 6 to update any files that were copied from the

NT 4.0 Workstation CD. Use Windows Explorer to look for Service Pack 6 on the C drive. If the SP6 folder is on the HDD, you can install it by going to C:\SP6\Update. Click on Update.exe. From the Welcome screen, Accept the License Agreement, deselect Backup and press install. If the SP6 folder is not on the HDD, proceed with step 1. If you do not find this folder, use the enCORE product CD.Follow the instructions in step E to reapply Service Pack 6.

E. Windows NT 4.0 Service Pack 6 Installation – 40 Bit Security (not required for preloaded systems) 1. Insert the product software CD. Wait for Autorun to launch and

display the LUNAR browser menu. Click exit and start Explorer. 2. Navigate to NT4sp6a\Update. Click on Update.exe. From the

Welcome screen, Accept the License Agreement, deselect Backup and press install. Restart the PC when prompted.

3. Wait for the PC to boot up completely and remove the CD from the drive.

Section 3. SETTING UP MICROSOFT OUTLOOK 2000/2002

B. Installing Outlook 2000

1. Insert the Microsoft Outlook 2000 CD into the CD ROM drive and wait for Autorun to launch.

2. At the Welcome screen, enter the Customers name and the Key Code and select Next.

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3. Click on I accept the terms in the License Agreement and select Next.

4. Select Customize. 5. From the Install Location dialog box, select Next. 6. From the Updating Windows dialog box, click the drop down menu

arrow and select “Do not upgrade Microsoft Internet Explorer” and select Next.

7. From the Selecting Features window, click on the yellow 1 by Symantec Fax starter; select Not available then select Install Now.

8. Wait for the files to be copied successfully and select Yes to restart when prompted.

9. Remove the CD from the drive.

C. Installing Outlook 2002 Note: Version >6.0 If the system you are installing Outlook 2002 on does not have the minimum required level of functionality, you will be prompted to update the Core System, Data Access Components and Web Browsing. If prompted to update, proceed with step 2, if not skip to step 4.

1. Insert the CD and wait for Autorun to launch. 2. If prompted to update, press Next. 3. From System Files Update Setup” drop down the selection menu

and select “Do Not upgrade I.E and press Next. Reboot when prompted

4. Enter the Product key (found on the back of the case), and press Next.

5. Accept the Agreement and press Install. 6. From the Type of Installation screen, click Next. 7. Begin the installation by clicking Install. 8. When the install is complete, press OK, remove the CD and reboot

the system.

New Outlook 2000/2002 Setup: If Remote Access Service (RAS) is installed, go to the appropriate section, either F or G. You can verify that RAS has been installed by right clicking on the Network Neighborhood Icon and selecting Properties. Select the Services Tab to see which services are installed.

D. Remote Access Service Installation

1. Right click on the Network Neighborhood Icon and select Properties.

2. Click the Services Tab and select Add. 3. Select Remote Access Service and select OK.

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4. Insert the WinNT CD when prompted (if Autorun Launches, close it) and select Continue.

5. From the “add RAS device” dialog box, verify the modem (56k fax internal PCI) is selected and select OK.

6. From Remote Access Setup, select continue. 7. From the Network dialog box select Close. 8. Select No when prompted to restart. 9. Install SP6.

E. Installing Windows-NT Service Pack 6 Note: If the SP6 folder is on the HDD, you can install it by going to C:\SP6\Update. Click on Update.exe. From the Welcome screen, Accept the License Agreement, deselect Backup and press install. If the SP6 folder is not on the HDD, proceed with step 1.

1. Insert the product software CD. Wait for Autorun to launch and

display the LUNAR browser menu. Click exit and start Explorer. 2. Navigate to NT4sp6a\Update. Click on Update.exe. From the

Welcome screen, Accept the License Agreement, deselect Backup and press install. Restart the PC when prompted.

3. Wait for the PC to boot up completely and remove the CD from the drive.

F. New Outlook 2000 Setup

1. Double Click on the Outlook 2000 Icon. 2. From the Outlook 2000 Startup screen select Next. 3. From the E-mail Service Options screen select Internet Only then

select Next. 4. From the “Your Name” dialog box, enter the customers name and

select Next. 5. From the “E-Mail Address” dialog box, enter the customers E-mail

address and select Next. 6. From the “E-Mail Server Names” dialog box, enter the Server type

and Incoming and Outgoing Servers and select Next. 7. From the “Internet Mail Login screen, have the customer enter their

E-mail password (and name if necessary) and select Next. 8. From the Friendly Name dialog box select Next. 9. Choose the appropriate connection type and select Next. Most likely

a Phone Line (Modem) connection. 10. Enter the location information (area code) and select Close. 11. Enter the Telephone number used to connect to the ISP and select

Next.

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12. Enter the User Name and Password used to login to the Internet and select Next.

13. From the Advanced Settings screen, select Next. 14. At the Dial-up connection Name dialog box, enter a name for the

connection (e.g. the ISP), and select Next. 15. Select Finish. 16. Select Yes to accept Outlook as the Default Manager.

G. New Outlook 2002 Setup enCORE v6.0 or newer

1. Double Click on the Outlook 2002 Icon. 2. From the Outlook 2002 Startup screen select Next. 3. From the Account Configuration screen press Next. 4. From the “E-Mail Accounts” dialog box, select the Server type

(generally POP3) and press next. 5. From “E-Mail Accounts (Internet E-Mail Settings(POP3))”, enter

the customers Name, E-mail address, Incoming/Outgoing Servers and the customers User Name and Password. Press “More Settings” and click on the Connection tab to select the connection type (i.e. Modem, LAN). Note: If selecting a Modem, you’ll need to add a Dial-Up Network Connection, press the Add button. From the “Phone book Wizard”, enter a name for the new Phone book (e.g. the ISP) and press Next.

6. Select “I am calling the Internet” and press Next. 7. Enter the Telephone number used to connect to the ISP and select

Next. 8. Press OK to close the Internet E-Mail settings dialog box. 9. Press Next to continue. 10. Select Finish.

With Outlook 2002, you’ll need to add the Personal Address book. 1. To add one go to Tools/E-mail accounts and click on Add a new

Directory or Address book and press Next. 2. Click Additional Address books and press Next. 3. Highlight Personal Address book and press Next. 4. From the Personal Address book screen press Next. 6. Press OK and exit Outlook to activate the account. 7. Go to Tools/Address book. In the Show Names from the: field,

drop down the list and select the Personal Address book. 8. Select Tools/Options and make sure that the Personal Address

book appears in all 3 fields. If the PAB does not appear in When sending mail, check names using these Address lists in the following order, select Add, highlight PAB and press Add and then Close. Use the arrows to move the PAB to the top.

9. Press Apply, OK and close the address book.

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Section 4. SETTING UP WINFAX PRO SOFTWARE

A. Configuring Windows NT to use the fax modem

1. In Windows NT Control Panel, double click the “Modems” icon. Verify

that in the list of modems there is an entry for “U.S. Robotics 56K Fax PCI” appears. If the “U.S. Robotics 56K Fax INT” entry does not appear, it must be added to NT. To add this modem to NT, check the Don’t Detect checkbox and then the Next button. Select Have Disk and insert the CD included with the modem. Change the drive letter to the root directory of the CD and continue. Select 3Com Corp. as the “Manufacturer” and U.S. Robotics 56k FAX INT as the “Model”, and select Next.

2. When the Windows NT modem “Dialing Properties” dialog appears for the U.S. Robotics 56K FAX modem, complete the “Dialing Properties” dialog as appropriate for the customer’s site. Windows NT has on-line help available for this task.

3. Don’t forget to connect the modem to the phone jack with a standard (RJ-11) phone cable.

H. Installing WinFax PRO

1. Insert the WinFax installation CD and wait for autorun to display WinFax Pro Menu Screen.

2. Select Install. 3. At the Welcome Screen, select Next. 4. At the License Agreement Screen, select Yes. 5. Select Next at the User Information Screen. 6. Select Next at the Destination Folder Screen. 7. The Default Setup Type is Typical, select Next. 8. Select Next at the Select Program folder. 9. Select Next at the Start Copying Files screen. 10. At the File Copy Complete screen, select Next. 11. Select Next at the WinFax Pro Setup (CSID) screen. (Leave the fields

blank) 12. At the “Modems and Other Fax Devices” screen, select the “56K

FAX modem” from the modem and device list if it is not already selected and select Next.

13. Select Next to Test the Modem. 14. The results of the Test list the class and speed of the Modem. Select

Next to continue.

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15. With “Yes” selected in the “Enable Controller” dialog box, select Next.

16. From the Configure E-Mail screen, select Next. 17. Select Cancel at the Online Registration screen and Yes to “Are

You Sure?” select Next. 18. From the Ready to Configure System screen, select Finish. 19. Select NO to the Readme question. 20. Select Cancel the Live Update. 21. Select Yes to the Message Manager. 22. From the Phone book autolink screen, check Outlook 2000 and

select OK. 23. Select Next at the Phone Book Name 24. Select the Set Information button. 25. Select the “Use Business Related Information” Radio button (if not

already selected) and select OK. 26. Select Finish 27. After rebooting Windows NT and logging back on, verify that the fax

icon appears on the status bar. 28. Close the Printers Dialog box and remove the CD. 29. Verify that you select WinFax as one of the available printers from

within the application and that you can fax a patient report to Lunar service or some other destination.

Section 5. SETTING UP ADDITIONAL TELEDENSITOMETRY OPTIONS

NOTE: There must be a functional network connection in order for the installation of Windows Networking to be tested. Consult with the customer’s IS department, or Network person, to determine the protocols and services required. If a workgroup (no server) is used then the specific TCP/IP address will have to be known before installing the NIC. If a DHCP Server is used, then a Computer Name and Domain must be known before installing the NIC. The Computer Name will have to be changed to match the one given by the Network Administrator. To change the Computer Name, Right click on Network Neighborhood from the Desktop. Go to Properties| Identification and Change. Edit the Computer Name and the Workgroup or Domain name. Reboot when prompted. DICOM and HL7 features require TCPIP protocol and default Windows Networking services to function properly. LUNAR factory PC’s will be setup to use a DHCP server. To change to a specific IP address:

1. Right click on the Network Neighborhood icon 2. Click on Properties 3. Click on Protocols 4. Click on TCP/IP Protocol 5. Make sure you are in the IP Address tab 6. Select the Specify an IP Address radio button

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7. Insert the correct IP address and subnet mask given by the IS support staff.

8. Click OK, Apply, OK and Restart to restart the system and complete the change to a specific IP address.

A. Setting up AutoMentor

Refer to the enCORE™ Operator’s Manual Outbox Options sections for more information.

B. Setting up EMAIL Refer to the enCORE™ Operator’s Manual Outbox Options sections for more information.

C. Setting up DICOM Refer to the DICOM Operator’s Manual for setup information.

D. Setting up HL7 Refer to the LUNAR Ambassador HL7 Interface Configuration Manual for setup information.

E. Setting up MULTI-USER DATABASE (MUDBA)

When setting up the Multi-User Database, several issues will have to be considered.

1. Where will the database reside, on the Prodigy or DPX-NT PC or other peer-to-peer network or network server drive?

2. How will the site archive data? 3. Will the site share a printer?

When sharing drives, make sure that you use the “New Share” option. Sharing the drives as “C$” can cause the sharing to be unsuccessful.

These issues should be determined by the site who is also responsible for setting up the Multi-User Database on additional PCs. When installing enCORE™ software on other networked PCs, you can install the software in a workstation mode. Note: PC must be running a supported Operating System, either WinNT or WinXP.

1. Install the software from the CD using install option number 2. 2. Launch the enCORE™ software. 3. Disregard any errors about primary calibration files. 4. Go to Tools|User Options|Systems tab and check the Auxillary

Workstation checkbox. Click OK to leave the User Options menu. 5. Close the enCORE™ application and relaunch it. 6. You will now be in the workstation mode. NOTE: you will not be able to perform patient measurements,

QA’s or simulated measurements or simulated QA’s in the worksation mode.

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Refer to the document Setting Up a Multi-User Database for further instructions.

Section 6. Windows XP setup and configuration.

All WinXP systems come with Modem and Networking factory installed and configured (Networking is setup as a Workgroup, see the site’s Network Administrator for Domain configuration). The computer name is ENCORE-XP.

NOTE: There must be a functional network connection in order for the installation of Windows Networking to be tested. Consult with the customer’s IS department, or Network person, to determine the protocols and services required. If a workgroup (no server) is used then the specific TCP/IP address will have to be known before installing the NIC. If a DHCP Server is used, then a Computer Name will have to be changed to match the one given by the Network Administrator and the will have to be changed from a Workgroup to a Domain.

• To change the Computer Name, go to Start/Control Panel/Network and Internet connections/Network connections. Drop down the Advanced menu and select Network Identification, Click the Change button. Change the name and reboot.

• To set up the PC on a Domain, follow the same steps. • To change to a specific address, go to Start/Control Panel/Network and

Internet connections/Network connections. Right click on the Local Area Network and select Properties. Double click on Internet Protocol (TCP/IP). Click the radio dial Use the following IP address and enter the correct IP address and subnet mask provided by the Network Administrator or the IS support staff.

Installing Outlook 2002

1 Insert the OL2002 CD in the CDD and wait for Autorun to launch 2. Enter the Product key (found on the back of the case), and press

Next. 3. Accept the Agreement and press Next. 4. From the Type of Installation screen, change the path from C: to

D: and click Next. 5. Begin the installation by clicking Install. 6. When the install is complete, press OK, reboot the system and

remove the CD. New Outlook 2002 Setup

Note: After setting up Outlook, the customer should be instructed to archive their mail on a weekly basis. This backup should place the archived file on the D: drive. In

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the event a customer uses the recovery image and they have not archived their mail to the D: drive, it will be lost including all contacts.

1. Double Click on the Outlook 2002 Icon. 2. From the Outlook 2002 Startup screen select Next. 3. From the Account Configuration screen press Next. 4. From the “E-Mail Accounts” dialog box, select the Server type

(generally POP3) and press next. 5. From “E-Mail Accounts (Internet E-Mail Settings (POP3))”, enter

the customers, • Name • E-mail address • Incoming/Outgoing Servers • The customers User Name and Password. • If the customer is connecting via modem, click on the More

Settings button. • Click the Connections tab and click in the radio button by

Connect using my phone line. • Under Modem click the Add button and with Dial-up to private

network selected, press Next. • From the Phone Number to Dial screen enter the Telephone

number used to connect to the ISP and select Next. • Enter a name for the connection (e.g. the ISP), and press Finish

and then OK to close the Internet E-mail Settings dialog box. • Press Test Account Settings and enter your Internet User

Name and Password. Check the box to Save this User Name and Password, click in the Me Only radio button and press Dial. You should connect to your ISP and all tests should complete with no errors. Click Close to exit the Test dialog and Next to continue.

6. From the Congratulations screen press Finish. At this point you’ll be prompted to Activate your Outlook software. You can Activate it later but should be activated prior to using the e-mail feature in the encore software.

With Outlook 2002, you’ll need to add the Personal Address book.

1. To add one go to Tools/E-mail accounts and click on Add a new Directory or Address book and press Next.

2. Click Additional Address books and press Next. 3. Highlight Personal Address book and press Next. 4. From the Personal Address book screen, point the path for the

address book to D: press OK. 10. Press OK and exit Outlook to activate the account.

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11. Start Outlook and go to Tools/Address book. 12. From the Address book, Select Tools/Options and make sure that

the Personal Address book appears in all 3 fields. If the PAB does not appear in “When sending mail, check names using these Address lists in the following order”, select Add, highlight PAB and press Add and then Close. Use the arrows to move the PAB to the top.

13. Press Apply, OK and close the address book. Archiving

1. First create a folder on the D: drive using Explorer, i.e. Outlook Archive

2. From the main tool bar, click on Tools and select Options. From the Options page, click on the Other tab. Click on the AutoArchive… button. Click browse and point the path to the folder you just created.

Section 7. TROUBLESHOOTING

CANNOT COMMUNICATE WITH THE NETWORK. If you cannot seem to communicate with the network, try the following:

1. Check the connection of the network cable into the network connector at the back of the computer.

2. Check to see if the lights next to the connector are illuminated. Both the send and receive lights should be illuminated.

3. If you are using a DHCP Client, make sure that DHCP is enabled. Refer to section D.3.ii.

4. Go to an MS DOS prompt from the desktop and ping the NIC (see example below). If this is successful then ping an address on the network. If this is not successful then you have a problem with the NIC or network setup on the PC. If you can ping the local PC but not the network then have the site contact there is staff to look into the problem further.

i. Example: If you know the address of the network card type; ping 175.100.42.110 (example of a TCP/IP address) and press Enter.

WINFAX IS INSTALLED BUT REPORTED NOT INSTALLED. After attempting to fax a report using WinFax, the system displays the error message “Printer driver is missing or the printer is not installed.” The cause of this problem is that Symantec’s installation program for WinFax does not update the Windows Registry correctly with any dependability. So even though WinFax is installed, the enCORE™ software cannot use WinFax on some installations because it cannot find WinFax’s default device mode settings. You can verify

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this is truly the cause of the problem by looking at the Windows Registry using the REGEDIT program. Confirm the absence of the Registry key named “DefaultDevMode” under the key named “HKEY_LOCAL_MACHINE\System\Current Control Set\Control\Print\Printers\WinFax”. PLEASE NOTE: incorrect use of the REGEDIT program can leave the PC inoperable!

• On the Windows ‘Start’ menu, select ‘Settings’ and then ‘Printers’. Then right-click on the ‘WinFax’ printer icon, and select ‘Document Defaults

• Under the ‘WinFax Document Settings’ tree view, expand the ‘Paper/Output’ entry and select ‘Orientation’.

• Change the ‘Orientation’ value from ‘Portrait’ to ‘Landscape’. Select ‘OK’.

• Once again select WinFax’ ‘Document Defaults …’ dialog, and then select ‘Orientation’.

• Change the ‘Orientation’ value from ‘Landscape’ to ‘Portrait’. Select ‘OK’.

• There should now be a key in the Registry named HKEY_LOCAL_MACHINE\System\Current Control Set\Control\Print\Printers\WinFax\DefaultDevMode”.

• Within Prodigy, you should be able to fax a report now.

GENERATED RECORDS None.

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DOC. ID: DXPC2004 REVISION: G DATE: 12/06/02 WRITTEN BY: Jeff Salbego

MANUFACTURING PROCEDURES

GE Medical SystemsLUNAR

g

APPROVED ON CO: L10507

TITLE: enCORE PC Configuration Procedure /Win-XP

PURPOSE This procedure is used to setup a PC and software for Drive Imaging enCORE (aka Prodigy, DPX-NT, and DPX-MD+).

APPLICATION This procedure applies to all PC’s and software. Execute appropriate procedure steps based on the model of PC to be configured and the features requested by the sales order.

SAFETY PRECAUTIONS Disconnect the line cord from the Computer before opening the enclosure.

Precautions should be taken (e.g. wearing of grounding straps, etc.), when necessary, to ensure a static-free environment exists when handling and installing PCB’s and other static sensitive devices.

ASSOCIATED MATERIALS DXPC2003 - Prodigy / DPX-NT PC Testing Procedure

MINIMUM HARDWARE SPECS • 900MHz Intel Celeron processor • 512 MB RAM • 20 GB hard drive • 8 MB video RAM • 52X CD ROM • 250 MB Zip drive • 56k Modem • 10/100 MB network card • Microsoft Windows XP Professional (SP1) • 17” monitor • Super VGA (1024 X 768) or higher resolution video adapter

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CURRENT SOFTWARE VERSIONS Current Version Notes

Operating System Microsoft WinXP w/ SP1 Emailing Software Refer to Section O *Only required for TeleD Faxing Software Refer to Section P *Only required for TeleD PROCEDURES

Section 1. SETTING UP THE PC (Standard configuration)

Loading Application Software

A. Windows XP Professional Installation (not required for preloaded systems)

Section A of this procedure is used to: 1) Setup the Disk for imaging or, 2) When replacing the system drive, only if attempts to recover a corrupt system have failed. The steps described here will erase all data on the system partition. The data will not be recoverable.

1. Restart the computer with the Windows XP Professional CD in the CDD. 2. When prompted to boot from CD, press <Enter>. If you miss the prompt, reboot and

start over. 3. Press <Enter> at the Welcome to Setup screen. 4. Press <F8> to accept agreement and continue. 5. If a partition exists, use the up/down arrow keys to highlight it. 6. Press <d> to delete the partition.

Note: Deleting a partition will permanently destroy all data on the partition. Make sure any data has been backed up so that it can be later restored. This action is irreversible.

7. Press <Enter> to continue deleting the system partition. 8. Press <L> to verify deleting the partition. 9. If necessary, repeat the deletion of all existing partitions. 10. Press <C> to create a new partition. 11. Use the Backspace key to clear the Default Partition size and enter 12500 as the

partition size. Press <Enter> to accept the partition size. 12. Cursor down to the unpartitioned space, press <C> to create a second partition.

Use the Backspace key to clear the Default Partition size and enter 20000 as the partition size. Press <Enter> to accept the partition size and create the second partition.

13. Cursor down to the unpartitioned space, press <C> to create a third partition. Press <Enter> to accept the default size and create the third partition. The 3rd partition is where the recovery image will be stored and Must be formatted as FAT32.

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14. With drive <C> highlighted, press <Enter> to install the Partition. 15. Select the desired file system using up/down keys. Select “Formatting using NTFS

File System” (the default) and press <Enter> to continue. 16. Wait for partition to be formatted. 17. Wait for the file copy to complete. 18. Leave the CD in the CDD and press <Enter> to restart the computer. Do NOT boot

on the CD. 19. Once the system restarts it will proceed with installation. 20. Accept the defaults from the Regional & Language Options screen by pressing

<Next> 21. Type in GE Medical Systems Lunar for both name and organization and press

<Next>. 22. Type in the Product ID from the Certificate of Authenticity and press <Next>. 23. Type in ENCORE-XP for the Computer Name; do NOT enter a Password and press

<Next> to continue. 24. Verify time and date; select the appropriate time zone, (Central Time(US and

Canada) and press <Next> 25. From Networking Settings, accept the default (typical) and press <Next> 26. Press <Next> to setup the PC in a Workgroup called Workgroup. 27. When all the files have been copied, the system will reboot. Wait for it to restart and

press <Next> to setup the computer. 28. When prompted to connect to the Internet press <Skip> 29. Select <NO> to the Registration, and press <Next> 30. Enter in GE Lunar as name for the user and lunar (lower case) for the password

and press <Next> 31. Press Finish/Next and the OS will boot. 32. Remove the CD 33. Click Start. Right click on My Computer and select Manage. Double click Storage

and then Disk Management. 34. Right click on (G:) and select Change Drive Letter and Paths. Click the Change

button and change the Drive Designation to (H:) temporarily. Confirm the change by pressing Yes.

35. Repeat the process till the letters are assigned as follows; 36. The Hard Drive (Disk 0) should be C: D: and G: 37. The Zip drive (Disk 1) should be E: 38. The CDD should be F: 39. Right click on the D: partition of disk 0 and select format. Enter “Applications” as

the volume label and press OK to format the partition with the NTFS file system. 40. Right click on the G: partition of disk 0 and select format. Enter “Recovery” as the

volume label, change the File System to FAT 32 and press OK to format the partition.

41. Open My Computer. Right click on C: and name the volume GE Lunar. 42. Close Computer Management.

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43. Install XP-Professional Service Pack 1 found at netserver\R&D\software(32bit)\WinXP\SP 1 Note: If you’re installing other devices that need to copy files from the WinXP CD, install them prior to installing SP1.

B. Setting up the Network (Not necessary for Imaging purposes) 1. The Network is automatically setup (in a Workgroup) as the OS is installed. 2. To verify the connection, make sure the PC is connected to the Network and go to

Start\Control Panel\Network and Internet Connections\Network Connections. 3. If the connection is disabled, double click on the Local Area Connection to Enable

service. Click on My Network places. 4. Click on View workgroup computers and verify you can see other computers in the

workgroup.

C. Configuring the Network for a Domain • Start\Control Panel\Network and Internet Connections\Network

Connections. If the connection is disabled, double click on the Local Area Connection to Enable service.

• Drop down the Advanced menu from the tool bar and select Network Identification.

• Click the Change button. Under Member of, click in the Domain radio button. Enter Lunarcorp and press OK. Note: You will need a unique computer name and Administrator rights.

• Enter User name and password and press OK. • When you’re welcomed to the domain, press OK and restart when

prompted. D. Video Driver Installation (not required for preloaded systems)

All devices are detected and installed automatically by WinXP This is where new procedures for new devices/drivers will be added.

E. Internet Explorer Installation WinXP by default is bundled with I.E. version 6. Installation is not necessary at this time. This is where update/new procedures will be added.

F. Configure Desktop Settings (repeat for each user) 1. Right mouse click on an open space in the Task Bar and select Properties to

configure Task Bar properties – Clear the Check mark from Keep the Taskbar on top of other Windows option. Remove the check mark from Hide inactive Icons, press Apply and OK.

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2. Right click in an open area of the Desktop and select Properties. Select the Desktop tab and set the Background to None. Click on Customize desktop. Remove the check mark from Run Desktop Cleanup Wizard every 60 days and press Apply

3. Click the Screen Saver tab, set the Screen Saver to None. Click the Power button and set all options under Power Schemes to Never. Press Apply and OK. 4. Click the Appearance tab and change the Windows and Buttons setting to

Windows Classic and press Apply. 5. Click the Settings tab and set the Screen resolution to 1024x768 and color

Quality =Highest (32bit) If no changes were necessary, proceed to step # 6 6. Press Yes and OK to set the selections and exit the display setup. 7. Go to Start\Control Panel. Click on Date, Time, Language and Regional Options.

Click on Regional and Language Options. Click the Customize button and then select the Date tab. Set the short date format to mm/dd/yyyy. Click Apply and OK, OK.

8. Click on Date and Time. Select the Internet Time tab and remove the check from Automatically synchronize with an Internet time server. Press Apply and OK.

9. Click the Back ← and open Performance and Maintenance. Click on the System Icon.

10. Click on the Advanced tab and then Error Reporting. Click in the Disable error reporting radio dial. Press OK. Click Settings from the Performance box and then select the Advanced tab. Click Change in the Virtual Memory box and change the Paging File size of drive “C” in both the Initial size and the Max size to 1000. Click Set, OK, OK. Reset when prompted.

11. Click on the System Restore tab and check the box for Turn of System Restore for all drives. Press Apply and a message pops up asking if you really want to stop System Restore. Press Yes.

12 Click on the Automatic Updates tab. Click in the Turn off automatic updating radio button. Press Apply and close everything up.

13.Press Start, Right click on My Computer and select Manage. Expand Services and Applications. Click on Services to disable the following service. Double click on Web Client. Stop the Service and set the Startup Type to Disabled. Press Apply and OK.

14. Open Device Manager and expand USB Controllers. Right click on the first USB Root Hub and select Properties. Open the Power Management tab and de-select the Power Save option. Press OK and close the Computer Management screen.

15. Close the Computer Management window. 16. Press Start, All Programs and select Windows Messenger. Cancel the .Net

Passport Service setup. From the Windows Messenger dialog box, drop down the Tools menu and select Options. Click the Preferences tab and remove the check mark from both “Run this program when Windows starts” and “Allow this program to run in the background”. Press OK.

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QUALITY SYSTEM DOCUMENT Page 6 of 16 It is the responsibility of the user to verify this document originated from the controlled master and is the active revision prior to use. This document contains confidential or proprietary information of GE Lunar. Neither the document nor the information therein is to be reproduced, distributed, used or disclosed, either in whole or in part, except as specifically authorized by GE Lunar.

G. Install MultiLingual User Interface (MUI) Subject to change

1. Insert the CD label Disk 1 2. At the Welcome screen, Accept the License Agreement and press Continue. 3. Check all languages in the Install Languages for menus and dialogs screen and

press OK. 4. Insert the Windows XP CD when prompted and click OK. 5. Wait for the files to copy and insert the MUI CD disk 1 and press Yes when

prompted. 6. When the fonts are installed press OK, and reboot when prompted. 7. Repeat the process with all MUI Disks. Disks 3 and 4 do not auto run

H. Install (PCI) Modem Card and Drivers (Installed on all PC’s)

With the PC shut off, unplugged and grounded, insert the Modem (supplied from OTC) in the 3rd PCI slot. Startup the PC and from the New Hardware Wizard, select install from a list or specific location (Advanced) and press Next Select Search removable media, insert the OmniTech Technical Data CD (v1.81 or higher) and press Next. The Wizard will find the driver and install it. Open the control panel, select printers and other hardware then Phone and Modem options. From the Modem Setup screen, enter 608 for the area code and press <Next> To test the Modem, use Dialer found in the WinNT folder. Open Dialer and drop down the Phone menu from the tool bar and select Dial. Enter the number to connect to, click in the Phone call radio button and press Place Call. Press Disconnect and close the Phone dialer.

I. SeaCOM Serial Adapter Hardware Installation (PRODIGY ONLY)

Check Jumper settings on board: J1A = On for P,P,T and off for L, L J1B = All jumpers off J1C = DIV2 on and off for DIV1 and DIV4 1. Copy files to the HDD and Setup prep.

• Using Explorer, create a folder on the D: drive Program Files. Create a folder in this folder called SeaCOM.

• Copy the SeaCOM drivers into this folder. • Use Explorer to run the Setup program from the SeaCOM folder

on Drive D: • From the Welcome screen, press Next. • Accept the agreement by pressing Yes.

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• Press Next at the Customer Information screen. • Accept the default Destination Location by pressing Next. • Accept the default Setup Type (Typical) by pressing Next. • Accept the default Program Folder by pressing Next. • Un Check Launch Help File and press Finish. • Shut down computer using “Start|Turn off Computer”. • Unplug the PC and Remove the cover. • Remove blank panel from PCI slot 2 to make room for SeaCOM

serial card. Note: Slots are numbered from the inside to the outside with the inside slot being number one.

• Install the SeaCOM PCI card into slot 2. Secure the card into slot using the screw removed from blank panel.

• Insert power cord and turn power on. • After the system boots, it will detect the card and the New Hardware Wizard will start.

2. Installing the Drivers

• Press Next at the New Hardware Wizard. • Press Continue Anyway from the Compatibility Warning. • Press finish to close the Wizard. • The New Hardware Wizard will start up again, press Next. • Press Continue Anyway from the Compatibility Warning. • Press finish to close the Wizard. • To Test the card, follow the steps at the end of step L.

Note: All PC’s from OTC come with a modem. The SeaCOM card will be

configured as COM4.

J. Creating the Recovery Image

Prior to creating the “Recovery “ image (this is an image of the operating system setup prior to Lunar Application software installation) verify/perform the following-

1. Empty the Recycle Bin. 2. Verify there is no errors from the last boot in the Event viewer. Start, Right click on

My Computer and select Manage. Expand Event viewer and check and clear all events from both Application and System.

3. Disable “Autoplay” for the Zip drive by installing TweakUI. Found at (\\netserver\R&D\Software (32bit)\WinXP) or see the PC setup department. Run Setup. Go with the defaults except, select Custom install and install only the TweakUI component.

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4. From the Programs menu, run TweakUI. Expand My Computer. Expand AutoPlay. Click on Types and disable AutoPlay for Removable drives.

5. Install Acrobat Reader. • Insert the enCORE CD and exit the browser • Use Explorer to run Setup from the Acrobat folder. • Click Next at the Welcome screen. • Click Next at the Destination Location screen. • Press OK to finish.

6. Remove TweakUI 7. Refer to LUPC0006 to create the Image. Make the Recovery image and copy it to G: 8. All OmniTech PC models with on board LAN have networking installed. If the

system is not connected to the Network you’ll see a red X through 2 PC’s, which means the Network cable is unplugged. To stop this from being shown on the Task bar, click the red X. Right click on the Local Area Connection and Disable it.

K. Printer Setup:

HP940c • Setup the printer (with cartridges and paper), and turn it on. Connect it

to the PC and the basic 940c print drivers that come with XP will be installed.

• Open the Control Panel/Printers folder, right click on the printer and select Properties.

• Install the Enhanced driver from HP.In the Advanced tab click on New Driver. Click Next and then Have Disk.

• Point the installation to the enCORE cd. Path = Printer\WinXP\hp940c\enu\driversWin2k_XP

• Select the .INF file and click open. Click Ok to continue • Click Next, Finish and then Ok • Open the Printers folder (if necessary) and Delete the newly installed

printer. • Restart the PC and after logging in the printer will be detected. Point

the installation to the same path as in the step above and complete the installation. Subsequent installations of the 940c printer will install the enhanced driver. (note: delete the printer prior to creating the image)

• For USB printers turn off Power Management HP Business Inkjet 2280 Note: The very first time the printer is turned on it

can take up to 15 minutes to initialize and warm up. Also when an ink cartridge is changed it can take a while to prime.

• Connect the printer to the PC and cancel the new Hardware Wizard. • Insert the HP Printer Driver CD • Select Install Printer Driver • Press OK to install the software in English

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• Press Next at the Welcome screen and Accept the License Agreement

• With “Connect directly to this computer” selected, press Next • With Parallel selected and LPT1 highlighted, press Next • Select Custom setup and press Next • From the Components dialog box, deselect the HP Business Inkjet

2280 PCL 5C driver and press Next • Press Install from the Installation Settings dialog box • At the start of the installation you’ll receive a message stating that

Microsoft has not tested the driver. Press Continue Anyway • Form the Setup Complete window deselect Register Printer and

press Finish. Exit the HP Installer by pressing Exit twice. • Set the printer as the default printer and Print a test page by going to

the properties page of the printer by selecting Start/Faxes and Printers and right clicking on the printer.

HP 5550 • Connect the printer and from the New Hardware Wizard, select install

from a list or specific location (Advanced) and press Next • Select Search removable media, insert the HP CD and press Next. • From the list of drivers, click on \enu\drivers\Win2k_xp\hpf5550k.inf

and press Next. • Print a test page. • Exit the installation and close the New hardware wizard by pressing

Finish.

L. Application Software Installation (Not installed on the recovery CD) 1. Obtain the latest Production Master Application Software CD and insert it in the CD-

ROM drive. 2. Wait for autorun to display Lunar CD Browser menu. 3. Select product installation from Lunar CD Browser menu. 4. Press Yes to accept the EnCore Software License Agreement. 5. The Default is Install required components. Accept this and press Next to

continue. 6. The installation is in several parts. Restart the system (if prompted) after each

component is installed. 7. Press <Next > at the Product Welcome screen. 8. Press <Next> at Information screen. 9. Press <Next> at the User Information Screen. 10. Press <Next> at Install Location screen. (accept default location). 11. Press Next to continue. 12. Leave the System# and Feature Code fields blank and press <Next> to continue. 13. Press <Next> to “Start Copying Files” 14. Press <Next> to “Start Copying Files”

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15. Select Yes “I want to Launch Prodigy/DPX-NT (or MD+)” now and Press Finish. As the Software opens, you will receive a few dialog boxes. (The SeaLevel COM Port will be Auto detected.)

• If Tele-D is enabled in the feature code and Outlook is not yet configured, you will be prompted with an error message from Outlook stating there is no default mail client followed by an application error message stating, “Enhanced messaging API is not available. These message boxes will appear on application startup until Outlook is properly configured.

• Click OK to create a New QA Database • Click OK at “ No Primary Calibration file is specified” (Prodigy only) • Click OK at “ No Database Connections” • Set the archive path to the appropriate drive letter, if not A: and set the

database path to D: Click OK to accept the New Database. • Remove the CD and test the SeaLevel card. Connect the PC to Test box 1

located in the PC setup room. From the main menu, select Tools/User Options. Click in the Service Check box and enter Award (Case Sensitive) as the password. Click OK twice.

• Select Tools/Service Options. Click on the Serial tab and press Test Communications. The only test that should timeout (Prodigy only) is the detector test (Waiting for ABT-TIMEOUT), all other tests should return with OK. Exit the Software only. Do not shut down the PC at this time.

M. NIC Installation. (Network Interface Card) Note: Omni Tech PC Models

# OEM-1000D01810E, 8100D05815 and the OEM-3124D00 Halyron ESG come with integrated Networking. Startup the PC and from the New Hardware Wizard, select install from a list or specific location (Advanced) and press Next Select Search removable media, insert the OmniTech Technical Data CD (v1.81 or higher) and press Next. The Wizard will find the driver and install it. Re-install Service Pack 1

N. Zip Drive Installation Hardware - Refer to LUPC0001 (Verify latest Rev) for the drive

installation procedure.

Software - All devices are detected and installed automatically by WinXP Drivers are not necessary but can be installed from Iomega’s website or PC Production

O. Installing Outlook 2002

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1. Insert the CD and wait for Autorun to launch. 2. Enter the Product key (found on the back of the case), and press

Next. 3. Accept the Agreement and press Next. 4. From the Type of Installation screen, click Next. 5. Begin the installation by clicking Install. 6. When the install is complete, press OK, remove the CD and reboot

the system. 7. After the system boots, insert the CD when prompted and press

OK. Refer to DXAP2030 for Setup/Testing Procedures.

For in-house testing purposes, Webserver must be turned on (see IT admin) • Use rdtest1 for the user name and password. (both lower case) • Incoming and outgoing servers are Webserver. • E-mail address is [email protected]

P. Installing the WinXP Fax Component 1. Click Start\Printers and Faxes. 2. Click on Set up Faxing 3. When prompted for the WinXP CD, insert the OmniTech

Recovery CD (Packaged with each system). Click OK. 4. Click on browse and point the installation to the I386 folder on

the CD. 5. Press Ok twice and wait for the installation to finish. 6. From Printers and Faxes, click on Install a local Fax Printer. 7. Close up Faxes and Printers. 8. Install SP1

• Configuring AutoMentor

1. Subject to change.) Verify that you select WinFax as one of the available printers from within the application and that you can fax a patient report to Lunar service or some other destination. AutoMentor is not enabled at this time.

Default Boot Sequence • FDD • CD-ROM • HDD

Q. PCI card slot assignment

• The 1st blank panel is for the 2nd serial port • PCI Slot 1: Adaptec SCSI Card (Optional) • PCI Slot 2: SeaLevel Serial Card

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• PCI Slot 3: Modem R. Creating the Image

Prior to creating the Final image (this is the image of the operating system setup with the Lunar Application software installed) verify/perform the following-

1. Empty the Recycle Bin. 2. Verify there are no errors from the last boot in the Event viewer (Start, Programs,

Administrative Tools, Event viewer) 3. Analyze/Defrag the HD (both drives) by going to Start, All Programs,

Accessories, System Tools, Disk Defragmenter. Run Analyze to see if Defrag is necessary. Note: All OmniTech PC models with on board LAN have networking installed. If the system is not connected to the Network you’ll see a red X through 2 PC’s, which means the Network cable is unplugged. To stop this from being shown on the Task bar, click the red X. Right click on the Local Area Connection and Disable it. Note: Prior to connecting a system to a LAN, the Connection must be re-enabled.

4. Refer to LUPC0006 to create the Image.

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Section 2. Duplicating Product Software If the appropriate version of software is already loaded on the local hard disk,

proceed with Step B. This can be verified by locating the appropriate folder named \product_X_XX_XXX on local hard drive; where product_X_XX_XXX is the product software version to be duplicated. Note: For Adaptec’s Easy CD creator instructions, refer to DXPC2000. A. Creating Master Software on Duplicator PC.

• Insert product “Master Setup CD” into CD-ROM drive. • Wait for Lunar CD Browser to start. • Exit Lunar CD Browser. • Create folder named \product_X_XX_XXX on local hard drive. • Copy entire contents of product “Master Setup CD” into folder created

above. • Wait for copy to complete and remove the “Master Setup CD” from the

CD-ROM drive. • Start NERO burning software. • Press the New button. • Select entire contents of the folder product_X_XX_XXX. • Drag and Drop the selected files and sub-folders to the CD layout. • Select File/Compilation Info, click the Label tab and name the

Volume to match the version of software. • Select File/Save.

B. Create Product CD.

• Insert blank CD into CD-ROM drive. • Start NERO burning software. • Press the New button. • Select entire contents of the folder product_X_XX_XXX. • Drag and Drop the selected files and sub-folders to the CD layout. • Click File/Write CD and then click on Write. • Press OK at the Compilation created successfully dialog. • Press Discard and remove the CD. • Validate CD layout using menu. • Apply label “Disk 1 of 2 Insert Disk, wait for AutoStart, follow directions” to

Application CD • Apply label “Mulit-Media Disk, Disk 2 of 2” to Multi-Media CD

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GE Medical Systems LUNAR

DOC ID: DXPC2004

REV: G DATE: 12/6/02 CO: L10507

QUALITY SYSTEM DOCUMENT Page 14 of 16 It is the responsibility of the user to verify this document originated from the controlled master and is the active revision prior to use. This document contains confidential or proprietary information of GE Lunar. Neither the document nor the information therein is to be reproduced, distributed, used or disclosed, either in whole or in part, except as specifically authorized by GE Lunar.

Section 3. Configuring Application Software

• Check Sales Order for System Number and Application Sites. • Get S/W Order Form FM03-4. • Start Configurator. • Enter System Number and select the options per the sales order. • Do not enable any application that does not have okay to ship status

unless approved by Regulatory Affairs. Review table below for latest status. If Regulatory Affairs approval is granted, then enable the application and add special “Investigation” label on software.

Application DPX-MD+

Release Status

DPX-NT Release Status

Prodigy Pro Release Status

Prodigy Oracle Release Status

Prodigy Vision Release Status

AP Spine Standard Standard Standard Standard Standard Femur Standard Standard Standard Standard Standard Total Body Optional

(Full-size Only)

Optional (Full-size Only)

Optional (Full-size Only)

Standard (Full-size Only)

Standard (Full-size Only)

Dual Femur Optional Optional Standard Standard Standard Advanced Hip Assessment

Optional Optional Optional Optional Standard

Pediatric Spine

Optional Optional Optional Optional Optional

Pediatric Total Body

Optional Optional Optional Optional Optional

Forearm Optional Optional Optional Optional Standard oneVision Optional Optional Optional Optional Standard Orthopedic Optional Optional Optional Optional Optional Lateral Optional Optional Optional Standard Standard HL7 Optional Optional Optional Optional Optional Multiuser DB Optional Optional Optional Optional Optional Teledensitometry

Optional Optional Optional Optional Standard

Dicom Optional Optional Optional Optional Standard Lateral View Not Available Not Available Optional Standard Standard Business Reports (encore composer)

Optional Optional Optional Standard Standard

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QUALITY SYSTEM DOCUMENT Page 15 of 16 It is the responsibility of the user to verify this document originated from the controlled master and is the active revision prior to use. This document contains confidential or proprietary information of GE Lunar. Neither the document nor the information therein is to be reproduced, distributed, used or disclosed, either in whole or in part, except as specifically authorized by GE Lunar.

Physician Reports (encore composer)

Optional Optional Optional Standard Standard

Animal body Not Available Not Available Optional. Need warning label 40122

Optional. Need warning label 40122

Optional. Need warning label 40122

CAD Optional Optional Optional Optional Optional OneScan Optional Optional Optional Optional Optional Hand Not Available Not Available Optional Optional Optional APVA Not Available Not Available IRB Only IRB Only IRB Only Absolute Fracture Risk

IRB Only IRB Only IRB Only IRB Only IRB Only

All other Software Options

Internal use only

Internal use only

Internal use only

Internal use only

Internal use only

Note: Compact systems do not require a configuration feature code. They are configured in the field at the time of install using Service Options.

Serial and System numbers: First Scanner Number First System Number DPX-NT (DPX-MD+) NTA Beta 70001 NT+70000 NTA Production 70101 NT+70000 NTB Beta 72001 NT+72000 NTB Production 72101 NT+72100 NTC Beta 73001 NT+73000 NTC Production 73101 NT+73100 DPX-NT 180 (DPX-MD+ 180) NTB-180 Beta 90001 NT-90101 NTB-180 Production NTC-180 Beta 91001 NT-91000 NTC-180 Production 91101 NT-91100 Prodigy Prodigy 1 Beta 60001 DF+10001 Prodigy 1 Production 60101 DF+10001 Prodigy 2 Beta 62001 DF+12000 Prodigy 2 Production 62101 DF+12100 Prodigy 3 Beta 63001 DF+13001 Prodigy 3 Production 63101 DF+13101

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QUALITY SYSTEM DOCUMENT Page 16 of 16 It is the responsibility of the user to verify this document originated from the controlled master and is the active revision prior to use. This document contains confidential or proprietary information of GE Lunar. Neither the document nor the information therein is to be reproduced, distributed, used or disclosed, either in whole or in part, except as specifically authorized by GE Lunar.

Prodigy 4 Beta 64001 DF+14001 Prodigy 4 Production 64101 DF+14101 Prodigy Compact Prodigy 3 Compact Beta 80001 DF-80001 Prodigy 3 Compact Production 80101 DF-80101 Prodigy 4 Compact Beta 81001 DF-81001 Prodigy 4 Compact Production 81101 DF-81101 Note, in each system number, the plus or minus symbol is used to denote total body option availability. This has been for historical purposes. Configurator is not conditionally tied to this convention. Application DPX-MD+ Release

Status DPX-NT Release

Status Prodigy Release

Status Production Release 6.70.021 on NT

hardware 6.70.021 6.70.021

Limited release for user tests at early adopter sites

7.00.286 7.00.286 7.00.286

• Configurator program automatically generates the feature code. • Select required printer, using menu command “File|Printer Setup”, to

Epson FX-880. • Print three labels. • Remove labels and place one on the S/W Production Form in the

designated area. Place the second label on the CD Diskette sleeve. Place the third label on the PC Form.

• Using Copy/Paste (Ctrl C/Ctrl V), take feature code from configuration and paste into Filemaker DB program.

• Fill out paperwork associated with software order form.

Note: Internal QA/Production software should be configured as System Number 00002 with all sites enabled.

GENERATED RECORDS DXPC2001 DPX Fan PC Configuration Form FM03-4 Software Order Form

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QUALITY SYSTEM DOCUMENT Page 1 of 6 It is the responsibility of the user to verify this document originated from the controlled master and is the active revision prior to use. This document contains confidential or proprietary information of GE Lunar. Neither the document nor the information therein is to be reproduced, distributed, used or disclosed, either in whole or in part, except as specifically authorized by GE Lunar.

DOC. ID: DXAP3031 REVISION: A DATE: 12/27/01 WRITTEN BY: Mike Buchholz

MANUFACTURING PROCEDURES

GE Medical SystemsLUNAR

g

APPROVED ON CO: L10122

TITLE: 230V Small Room Kit Installation Instructions

PURPOSE This procedure describes the steps necessary to install the 230V small room kit (including isolation transformer) at a customer's site. The isolation transformer reduces leakage currents from the computer and peripherals.

APPLICATION This procedure applies to all employees performing installation of a DPX-NT or Prodigy system. The small room kit is used whenever metal surfaces of the computer or peripherals are within 1.83 meters of the scan table (inside the patient environment).

SAFETY PRECAUTIONS Verify that power is not applied to the transformer when changing or checking the fuses.

ASSOCIATED MATERIALS None.

DEFINITIONS None.

PROCEDURES 1. VERIFY PROPER INPUT VOLTAGE

A. Measure the voltage at the wall outlet (or UPS if applicable). If the voltage is less than 180VAC, this transformer (LU8747) may not be used. If the voltage is 180VAC or more, proceed to step 2.

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QUALITY SYSTEM DOCUMENT Page 2 of 6 It is the responsibility of the user to verify this document originated from the controlled master and is the active revision prior to use. This document contains confidential or proprietary information of GE Lunar. Neither the document nor the information therein is to be reproduced, distributed, used or disclosed, either in whole or in part, except as specifically authorized by GE Lunar.

2. CONNECTING TRANSFORMER

A. Remove the label which covers the transformer input and discard it. If a UPS is being used, power the transformer and scanner from the UPS. Do not power the UPS or scanner from the transformer. This may overload the transformer.

B. The transformer may be placed on the floor, but it is best to place it on the computer cart. It should be placed such that its metal enclosure cannot easily come into contact with other equipment.

C. Verify that all peripherals have inputs which are suitable for voltages greater than 180VAC. Some peripherals may require that an input switch be appropriately set.

D. Attach all peripheral inputs to the transformer outputs using the cords provided. If an outlet strip was provided with the computer, discard it.

E. Power-up all peripherals and verify proper operation. 3. REPLACING FUSES

A. If no peripherals will power-up, it is likely that a fuse is blown. To replace the fuses, follow the steps below.

B. Unplug any cords from the transformer input. Using a standard screwdriver, open the fuse lid and remove the fuse carriage. See Figures 1 and 2.

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Figure 1 Opening the fuse lid.

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Figure 2 Removing the fuse carriage.

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QUALITY SYSTEM DOCUMENT Page 5 of 6 It is the responsibility of the user to verify this document originated from the controlled master and is the active revision prior to use. This document contains confidential or proprietary information of GE Lunar. Neither the document nor the information therein is to be reproduced, distributed, used or disclosed, either in whole or in part, except as specifically authorized by GE Lunar.

C. Replace the two fuses in the carriage with the spares taped to the transformer.

See Figure 3 for correct installation. See Figure 4 for incorrect installation.

Figure 3 Correct fuse installation.

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Figure 4 Fuse has slid out of holder. Reposition and try again. See Figure 3.

.

GENERATED RECORDS None.

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6 111Maintenance

Chapter 1:Maintenance This chapter contains brief discussions of the Preventative Maintenance procedure and Check Sheet as well as a discussion on unusual sounds and a listing of change orders associated with the Prodigy scanner.

6.0 Preventative Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-1696.1 Unusual Sounds . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-170

6.0.1 QA History. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-1696.0.2 Repacking the High Voltage Cable Connectors . 6-1696.0.3 Wear . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-1696.0.4 Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-1696.0.5 Inspection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-1696.0.6 Tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-170

6.2 Change Orders . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-170

PRODIGY Service Manual (Rev B - 1998) Maintenance6167

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6-168Maintenance PRODIGY Service Manual (Rev B - 1998)

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6.0 Preventative Maintenance• There are a number of items to be checked, cleaned and tested during a

PM visit to a site. See the Prodigy PM / Service Call Checklist in Appendix 6-A.

6.0.1QA HistoryAn important aspect of the PM is checking the QA History (see section ). This is important because when a QA is run during the PM, it should be consistent with the past QA's. Copy the QA history file to a diskette and send to the LUNAR Customer Service Department.

6.0.2Repacking the High Voltage Cable ConnectorsThe major work of a PM is the repacking of the High Voltage Cable connectors. See procedure DXSE0000 in the chapter 5 Appenices. It is VERY IMPORTANT that this procedure be understood completely before performing it!

6.0.3WearThe scanner should also be checked for signs of wear. The Shutter Assembly especially should be inspected.

Wear on these parts can cause lead shavings to fall on the filter in the x-ray beam. This can cause a drastic decline in Reference Counts, causing QA's to fail.

Also check all the scanner's moving parts for signs of wear.

• This would include wheels, pulleys, gears, bearings, belts, cables and motor assemblies.

• INSPECT CAREFULLY cables that enter the plastic cable track. These cables are subjected to a good deal of motion and thus have the potential for breakage!

• Also, when performing the various tests listed below, listen for any unusual noises that could be indications of wear.

6.0.4 CleaningCleaning the scanner is important.

• Remove dust and any debris from the electronics mounting chassis.

• Clean the transverse and longitudinal extrusions. Small bits of debris from the wheels may accumulate and impede motion.

• Clean the Shutter Assembly and the filter, if necessary (see 6.0.3).

6.0.5 Inspection

PRODIGY Service Manual (Rev B - 1998) Maintenance 6-169

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• Inspect the scanner internally and externally for obvious damage and loose connections.

• Check all PCB's for tight mounting screws.

6.0.6TestsRun all other tests according to the Prodigy PM check sheet.

6.1 Unusual SoundsA high pitched sound is normally heard when the scanner is in motion. This is caused by the high frequency motor pulses being sent from the Centent Motor Controller to the Transverse and Longitudinal Motors.

If the high pitched sound only occurs during motor operation, check the optical interrupt disks and verify that they are not rubbing against the black plastic transducer of the OMI board (see section 5.x). The disk should turn in the middle of the transducer's slot.

For other sounds of an apparent mechanical nature, check all appropriate gears and pulleys. Verify that the set screws are tightened and that the gears and pulleys are not out of position. With the scanner turned off, move the affected parts by hand to determine the exact source of the sound. Also look for rusted or worn bearings and examine the V-wheels for wear. With age, the longitudinal and transverse drive belts will dry out and start to cause noises. Treating these belts with belt dressing is a short term solution until they can be replaced.

Clicking or clunking sounds made during motor operation can be caused by belts that are riding up on their pulleys, or by a too tight bearing support. The bearing support is held to the carriage by a set screw from the rear. If this set screw is so tight that the bearing and support have no play (i.e. can be rocked 1-2 mm), it can cause a clunking sound during transverse motion. If this screw is loosened, it should be secured with Lock-Tite so it cannot work its way loose.

Pulleys that have become defective can also cause clicking and squeaking/squealing sounds. Try to isolate the movement of individual pulleys to locate the defective part.

Scraping sounds can be caused by any of the moving carriages, cables or cable track rubbing against an adjacent panel. Localize the sound and investigate the appropriate areas.

6.2 Change OrdersAs engineering changes are made to the Prodigy Scanner, they will be noted herein future revisions of this manual.

6-170Maintenance PRODIGY Service Manual (Rev B - 1998)

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QUALITY SYSTEM DOCUMENT Page 1 of 10 It is the responsibility of the user to verify this document originated from the controlled master and is the active revision prior to use. This document contains confidential or proprietary information of GE Lunar. Neither the document nor the information therein is to be reproduced, distributed, used or disclosed, either in whole or in part, except as specifically authorized by GE Lunar.

DOC. ID: DXSE0012 REVISION: G DATE: 2/28/02 WRITTEN BY: Jeff Franz

MANUFACTURING PROCEDURES

GE Medical SystemsLUNAR

g

APPROVED ON CO: L10173

TITLE: DEXA PM Work Instructions

PURPOSE This procedure describes the steps necessary to do a Planned Maintenance Check on a DEXA scanning system at a customer's site, and to assure that the system is operating within GE-LUNAR's specifications and in compliance with applicable Federal and State regulations.

APPLICATION This procedure applies to all employees performing Planned Maintenance or Site Certification of DPX Series or PRODIGY, and DPX-NT scanning systems.

SAFETY PRECAUTIONS When power is applied this equipment generates ionizing radiation. Take precautions that no part of your body passes through the x-ray beam when the equipment is energized.

ASSOCIATED MATERIALS DXAP0008 DPX-Series Installation Test Procedures DXAP2007 Prodigy Hacksaw Test DXAP3002 DPX-NT Installation Test Procedures DXQC0022 Aluminum Spine Phantom Scan Procedure DXQC2022 enCORE software Aluminum Spine Phantom Scan Procedure DXSE0036 OINK Daughter board and Limit Switch Field Replacement Instructions DXSE0038 DEXA PM Quality record

DEFINITIONS DPX Series scanners are all non- Prodigy, non- DPX-NT/MD+ scanners. enCORE based systems are all PRODIGY and DPX-NT/MD+ scanners. PRODIGY I systems are defined as PRODIGY systems with system numbers 11999 and lower. DPX-NT (A) systems are defined as DPX NT systems with system numbers 71999 and lower.

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REV: G DATE: 2/28/02 CO: L10173

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PROCEDURE

A. QA HISTORY AND ERRORLOG. 1. Perform a Quality Assurance test to insure the system is operating.

a. Verify that all tests on the QA are passing.

2. DPX Series scanners: The QA values needed may be found by viewing the QA database (F4 Database options – F2 QA History) and / or in the Daily QA printouts in the Customer’s QA binder. a. Verify that the Detector has not lost significant resolution by checking that

the high and low energy air counts have not decreased by more than 10% from the date of installation or the date of the last tube head or detector change).

b. Verify that the air ratio has not changed by more than .02. from the date of installation or last tube head or detector change (calculate from earliest QA or lookup on QA printouts).

3. Systems with enCORE software a. Copy the QA.mdb file to a diskette (Tools / Send Configuration / Select

Error Log and QA Database, make sure compress Files is selected and select Span Multiple Disks if necessary).

b. Select the appropriate drive (3 ½ floppy A: ) insert disk into drive and click OK.

c. Label with system number and PM, the file may be mailed to Service Engineering or email file to [email protected]

NOTE: This is only to gather statistical information on enCORE based systems performance, there will be no follow up regarding these QA histories.

4. Analysis of the QA History file

a. DPX Series i. Verify % Spillover is between 6.3 and 9.5 ii. Check the Air Ratio – it cannot deviate more than .02 since the last

detector / tube change iii. Check the low air counts – a change greater than 10% since the

date of last detector change indicates a failing detector iv. Check the Large standard Mass – should not deviate more than

2%

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v. If any of the above parameters are failing, call GE-Lunar Customer Support for help diagnosing the system.

1. To aid in diagnosis, email the QA.MDB file to [email protected]

5. Review the error log(s). b. DPX Series systems print from DOS prompt

i. C:\> ERRDUMP –L –N >PRN 1. See DPX Series CSB Vol 9 for DPX Series Error Log

Interpretation c. enCORE based systems Tools\ Error Log – add to instructions d. Verify that there are no hardware subsystem failures (X-ray, Detector,

Mechanical) e. Contact Lunar Service Department if any unexplained or unusual errors

are discovered in the error log. i. Error Log may be faxed to 608-826-7107 to aid in interpretation.

f. Delete error log for DPX Series (C:\LUNAR> del err_320.bin or C:\LUNAR del errlog.bin).

g. Start a new error log for enCORE-based systems by clicking on Initialize Log.

B. HOST PC MAINTENANCE

1. Clean the Printer according to the manufacturer’s instructions a. For Hewlett Packard Printers go to www.hp.com and search the support

pages for the customer’s printer model. 2. DPX series systems:

a. From a DOS prompt i. Delete contents of C:\SCRATCH and C:\PRNTMNGR directories. ii. Delete all *.CHK files in C:\ directory.

3. Software updates a. DPX Series systems: all DPX-IQ densitometers may be updated to

version 4.7e software free of charge. b. All other (non-IQ) DPX Series Densitometers should be running version

3.65 or 4.7e (if upgraded to IQ software) c. If the customer is running a version lower than 4.7e, or 3.65 ask them if

they are interested in this free update, they may get by contacting the GE-Lunar Apps line (USA) or you may order it from GE-Lunar at [email protected] or at 866-225-4771.

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d. enCORE based systems: i. Contract and Warranty customers are entitled to free software

updates (all software versions <6.0 are updates, > 6.0 is considered an upgrade and all customers must purchase it)

ii. Billable customers may purchase software updates by contacting GE-Lunar at 866-225-4771.

C. SCAN TABLE MAINTENANCE 1. Remove the scanner tabletop.

a. Power down the scan table. b. DPX Series tables – unlock the end panel doors and remove the tabletop

screws. i. DPX-IQ ii. Non DPX-IQ

c. DPX-NT – unlock the end panels and remove the tabletop screws. i.

d. PRODIGY – lift up the table pad and remove the 4 counter sunk 1/8” hex head screws in the 4 corners of the tabletop.

2. Clean the scanner interior a. Clean the electronics pan of dust and dirt. b. Wipe the dust and dirt off of the rear longitudinal rail and the transverse

rail. 3. Inspect mechanical parts and cables for wear and breakage.

a. Check all cables on the cable trough for wear b. Check the v-wheels on the rear longitudinal carriage for appropriate

tension Insert V-wheel instructions. 4. X-Ray Generator

a. Power up the scan table. b. Ramp the scanner to the appropriate kV / mA and read the test points on

the appropriate board as indicated in the X-Ray Settings table on DXSE0038.

i. DPX Series 1. Load the version specific diagnostic software from the Tools

disk – from a DOS prompt type: A:/diags/diagnos load c:/lunar

2. Enter the diagnostic software – from a C:\LUNAR prompt type: diags

3. Choose option 5 Static Counter

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ii. EnCORE based systems 1. Place the scanner in Service Mode

a. Options / User Options / check the check box for Service – Enter Password (Smile sw ver 1.0 – 2.05 or Award ver 2.10 +)

2. Go to Tools / Diagnostics / Scanner X-ray 3. Enter desired kV and ma – click on ramp

NOTE: Be sure to use your anti-static wrist strap when working on or near circuit board assemblies. .

5. Wedge Test (Rollover Test – DPX Series Only)

a. Select the Static Counter from the initial menu. When the static counter screen appears, use the arrow key to move the cursor to Operating Voltage, and enter 76.0.

b. Move the cursor to Tube Current and enter the number 150. c. Set the "Repeat" number to 20 and the "Printer" to ON.

i. If the AGS is operating properly, the low channel counts will be approximately 600,000 to 800,000 counts, and there will be fewer high channel counts in the range of approximately 400,000 to 700,000. Both counts will be stable to approximately +/- 3000 counts from one sample to the next.

d. Place the aluminum wedge test tool on the top of the collimator, with the thin edge toward the collimator’s larger aperture, and the thick edge away from the aperture. Insure that the aluminum wedge is NOT in the beam.

e. Press <Esc> and the shutter will open. Allow a 7 samples to appear on the monitor, and then slowly move the Aluminum Wedge through the radiation beam, starting with the thin edge of the wedge.

f. Move the wedge very slowly until the beam reaches an aluminum thickness of approximately 2 mm.

g. In the results displayed on the monitor, note the sample number where the high channel air counts begin to be reduced. At this point the counts in both channels should be reduced for the following samples. In other words: both the high and low channel counts must decrease consistently as the wedge enters the beam.

h. If the low channel counts increase at any point instead of decreasing, the AGS is not properly adjusted or the detector is failing.

i. This may cause "bone points" or white pixels in the image around the outside of a patient's Total Body scan and or white streaks in femur scans.

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i. Run the AGS wedge test and verify that it passes attach results to PM Check sheet.

6. Alignment verification / Mechanical / Cabling check

a. Run Air Matrix Scan i. Remove the tabletop if it is on. ii. In DIAGS select F4 QUALITY ASSURANCE TESTS, select option

3 – PERFORM AIR MATRIX SCAN. Choose 1 - Perform A Scan. Change the number of lines to the maximum value, also change the number of steps to the maximum value.

iii. Note the filename here_____________________________. This will have to be entered to analyze the data (filename format: XM followed by the 4-digit system number followed by MO.01A. Subsequent scans have extensions 01B, 01C, etc.) Then Press Esc to continue.

iv. Remove the detector collimator (non-IQ / MD systems only) and install the Air Matrix Piece (attenuation insert) or tape a 0.25 inch piece of aluminum over the detector (over on top of the collimator) to reduce the intensity of the beam.

v. Press Esc to begin the scan. The scan will take approx. 30 minutes to complete.

NOTE: If anything passes through the beam during this test, IT WILL FAIL. vi. Analyze the Air Matrix scan in DIAGS by selecting option F4

QUALITY ASSURANCE TESTS then select option 4 ANALIZE AIR MATRIX SCAN.

vii. Enter the Air Matrix file name when prompted and press the enter key.

viii. All categories must pass, see table 1 for Air Matrix values.

Category Limit Chi Squared 45 Skew +/- 0.07 Kurtosis +/- 0.07

Table 1: Failure Limits for the Air Matrix Test

ix. Print the overall values by answering Y (yes) when the software prompts

x. Return the printout of the passing Air Matrix with the PM Checksheet report (DXSE0038).

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xi. If any categories fail, check the deviation image for possible electronic or alignment problems, consult GE-Lunar OLC for assistance.

xii. Run a Daily QA from the system software, or a Peak from the diagnostic software, before trying the Air Matrix.

xiii. Once an acceptable Air Matrix scan is printed, delete the Air Matrix files (these files begin with "XM" or "XP" plus the System Number, and they are generally the only files beginning with "X" in the C:\LUNAR subdirectory).

b. Beam Wobble scan (Prodigy systems with software version 2.20 and

greater DXAP2011) or Alignment scan (Prodigy systems with software versions lower than 2.20 and DPX-NT/MD+ systems- DXAP3001) as appropriate and verify that it passes (attach the results).

7. Limit Switches a. Verify Limit Switch distances (DPX series Diags – F1 Limit Switch

Diagnostics / 1 Limit to Limit Distance; enCORE systems - tools / Diagnostics / scanner motion

b. DPX Series Only - Home the scanner c. Mark the home position on the Home Jig

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8. Replace the table top and screw down. a. DPX Series Only – Insure Home position is correct by using the Home Jig b. If necessary adjust limit switches

9. Daily QA Tests a. DPX Series only – check the peak setting on the QA last run

i. If peak is not 500 +/- 25 units adjust the peak 1. The voltage to the detector is controlled by the adjustment of

the potentiometer on the SBC board labeled HV ADJ - R43. 2. The voltage at TP18 of the SBC is equal to the detector

voltage divided by 1000. If R43 is adjusted to decrease the voltage at TP18 by 0.001, the peak will increase by 5 units.

3. The last peak value obtained during a Quality Assurance scan is stored in the Quality Assurance History database file.

DPXα

DPX-IQ / MD- 180 or DPXα w/ 4.1d or greater host

DPXL

DPX-IQ / MD- 240 or DPXL w/ 4.1d or greater host

DPX-SF

DPX-SF w/ 4.1d or greater host

PRODIGY 240cm Table

PRODIGY 180cm Table

DPX-NT / MD+ 240cm Table

DPX-NT/MD+ 180cm Table

(4-3) Transverse Steps

10920 –10960

10780-10820

12440 - 12480

12430-12470

10920 – 10960

10780-10820

12475 +/- 25

12475 +/- 25

12450 +/- 20

12450 +/- 20

(1-2) Longitudinal Steps

13360 – 13400

13280-13320

19880 - 19920

19730-19770

4225 –4265

4195-4235

19890 +/- 35

13790 +/- 35

19605 +/- 20

13530 +/-20

(3-4) Transverse Steps

10920 – 10960

10780-10820

12440 – 12480

12430-12470

10920 – 10960

10780-10820

12475 +/- 25

12475 +/- 20

12450 +/-20

12450 +/- 20

(2-1) Longitudinal Steps

13360 –13400 w/ 3.63 host

13280-13320

19880 – 19920 w/ 3.63 host

19730-19770

4225 - 4265 w/ 3.63 host

4195-4235

19890 +/- 35

13790 +/- 35

19605 +/- 20

13530 +/- 20

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If the next peak value obtained differs from the last value stored in the database by more than 50 units, the Quality Assurance scan will fail. If the peak must be shifted by more than 50 units to return it to 500 units +25, the peak must be adjusted in steps of less than 50 units (40 unit steps are recommended).

4. A complete QA must be run 5. between each step to update the Quality Assurance History

database file. 6. If the software peak setting corresponds to where both the

high and low channel counts are at a maximum, (see fig. 6.3) follow the steps outlined below. The graph on the QA will look similar to the one shown in fig 6.3 with the dashed vertical line (where the software thinks the peak is) on the graph at a point where both the high and low energy plots are maximized (the dashed curved lines). If the graph on the QA is unlike fig 6.3, go to part B of this procedure.

7. select "Peak / Set AMP Gain", then select "Perform Peak" and [Esc] to run the peak. Observe the results generated by the QA to determine if the software has selected the Amplifier Setting where both high and low channel counts are at a maximum. If not go to part B.

8. 3. If the peak requires adjustment, (is not within +/- 25 units of 500) connect a voltage meter to the SBC at TP18 (see fig 6.2). Put the meter to the VDC scale and record the voltage reading (e.g. 0.703VDC

9. Using the voltage recorded in step 3 and the peak value recorded in step 2 determine the appropriate voltage adjustment for R43.

10. To determine voltage adjustment: a. If Peak >500: New VTP18 = (Current Peak – 500)

/5 * + Old VTP18 b. Peak <500 New VTP18 = (500 – Current Peak) / 5 * –

Old VTP18 c. Do not attempt to adjust the peak by more than 40

units as an adjustment without a complete passing QA in the LUNAR software will cause a peak failure on the QA. For Peak settings that are more than 50 units away from 500 multiple adjustments are required.

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11. With your voltmeter attached to TP 18, adjust R43 (see fig 6.2) until your voltmeter reads what you determined in step 6.

12. From the main menu press F3 System Quality Assurance and place the System Standard on the table silk-screen with brass insert up and at head end of table. Press[Esc] and allow the QA to run in its entirety and to print out. Verify that QA passes.

13. If peak value is not within 25 units of 500, record peak value from the QA that was just run and the current voltage at TP 18. Using these values repeat steps A. 3-8 until Peak is within 25 units of 500 and a complete passing QA has been run.

b. Run two Daily QA’s and verify that they all pass (attach passing QA’s). i. Verify that all four-indicator lamps are functioning.

c. Start an additional Quality Assurance test and verify the function of the Emergency Stop button by using it to stop the system

10. Perform an AP Spine scan of the aluminum phantom (attach results) see

DXQC0022 (DPX Series) or DXQC2022 (enCORE based systems). a. Verify that the scanner is not “Hacksawing” – the edges on the spine

phantom image should be straight – if they are not i. Verify that the front and rear transverse pulleys are tight ii. Check for transverse binding iii. If the transverse belt is loose tighten it. iv. Prodigy Scanners – Run the Hacksaw test (DXAP2007).

b. The L2-L4 result should be within the expected range for the individual phantom.

c. % Fat result in (water based phantoms) should be within 4 to 5%. d. Verify that the Patient Positioning Switches and the Patient Locator Laser

are functioning. 11. Run a final Daily QA 12. Re check the last session in the error log and make sure it is free of hardware

errors. 13. Make a copy of the DEXA PM Check sheet for the customer, discuss any service

concerns with the system and explain work performed.

GENERATED RECORDS DXSE0038 DEXA PM Quality record

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DOC. ID: DXSE0038 REVISION: C DATE: 2/28/02 WRITTEN BY: Jeff Franz

MANUFACTURING PROCEDURES

GE Medical SystemsLUNAR

g

APPROVED ON CO: L10173

TITLE: DEXA PM Quality Record

ASSOCIATED MATERIALS DXAP0012 – DEXA PM INSTRUCTIONS CHECK LIST SYSTEM IDENTIFICATION SYSTEM NUMBER: _________________________ SCAN TABLE SERIAL NUMBER _________________________ PM DATE: _________________________ HOST PC MODEL :___________________________S/N:____________________________________ PRINTER TYPE:_____________________________________________________________________ SOFTWARE VERSION:____________________ (If Customer is a contract customer, verify that software version loaded is current – if it is not – order the current version for the customer.)

TEST EQUIPMENT USED Multimeter

TESTING

A √√√√ indicates a step has been completed satisfactorily, N/A indicates not applicable. Verify 20A Dedicated Outlet, all components ......................................................................................... _____

QA History and Error Log reviewed ......................................................................................................... _____

Mechanical Inspection Performed ........................................................................................................... _____

X-ray Settings verified (fill in table on page 2) ......................................................................................... _____

Peak Setting adjusted (DPX Series Only) ............................................................................................... _____

Detector Stability Test (Wedge) performed (DPX Series Only)............................................................... _____

Verify Limit Switch Positions.................................................................................................................... _____

3 Quality Assurance Tests Performed..................................................................................................... _____

Air Matrix or Alignment Test or Beam Wobble test performed................................................................_____

3 Aluminum Phantom Scans Performed ................................................................................................. _____

Host PC maintenance Performed............................................................................................................ _____

Printer Cleaned per OEM instructions ..................................................................................................... _____

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QA History (DPX Series Only) Installation* At PM % Difference

((Install-PM) / expected * 100)

Pass

AIR HIGH (Max = +/-10%) AIR LOW (Max =+/- 10%) LG STD MASS (Max =+/- 2%) Installation* At PM | Install – PM| Air Ratio Max = +/- 0.02 Spillover N/A Max = 6.3 – 9.5 *or date of last tube head change – check date of manufacture on compliance label X-Ray Settings

Test Point XORB

cSBC

KV mA (DPX series and PRODIGY)

(DPX-NT / MD+)

Limits (DPX series and PRODIGY)

(DPX-NT /MD+)

Actual

1 15 76 0.150 0.050 0.140-0.160

0.046-0.054

5 16 1 15 0.750 0.38 0.74 -

0.76 0.370 – 0.390

5 16 1 15 3.0 1.5 2.97 -

3.03 1.490 – 1.510

5 16 2 17 3.76 -

3.84 3.76 – 3.84

6 18 Peak Setting (DPX Series Only)

Before Adjustment After Adjustment Peak Setting

SBC TP 18

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Phantom Results

Phantom S/N____________ L2-L4 BMD % Fat

1

2

3

Average (sum/3)

Expected Value N/A

% Difference ((ave-expected) / expected * 100)

N/A

+/- 3% for Encapsulated Phantom

+/- 2% for Water Bath Phantom

(Circle One)

PASS

N/A

REPORTS PRESENT

A √√√√ indicates a step has been completed satisfactorily, NA indicates not applicable.

Beam Wobble (PRODIGY) or Alignment Test (DPX-NT/MD+) or Air Matrix (DPX Series) Results ....... _____

QA History reviewed on site .................................................................................................................... _____

Phantom Scan Printouts (include Ancillary results) ................................................................................. _____ Comments on any problems, adjustments made, parts replaced, issues, etc.: __________________________________________________________________________________________________________________________________________ _____________________________________________________________________ _____________________________________________________________________ _____________________________________________________________________ _____________________________________________________________________ _____________________________________________________________________ _____________________________________________________________________ Field Engineer ____________________/____________________ DATE ___/___/___