i Operation, Installation and Service Manual

Serial numbers and date of installation information must be supplie

Se numbers

Operation, Installation andService Manual

RFID Contrast Identification Accessory forMEDRAD® Stellant CT Injection System

with Certegra™ Workstation

Operation, Installation and Service Manual i

1 Introduction ......................................................................................1

1.1 Intended Use.................................................................................................................................................... 11.2 Certifications.................................................................................................................................................... 11.3 Contraindications........................................................................................................................................... 21.4 Required Training ........................................................................................................................................... 21.5 Symbols............................................................................................................................................................. 21.6 Definition of Terms ........................................................................................................................................ 31.7 System Configuration.................................................................................................................................... 3

2 Using the RFID Reader.......................................................................7

2.1 Conditions for Valid RFID Reading............................................................................................................. 72.2 In the Charging Base ..................................................................................................................................... 82.3 Removed from Charging Base..................................................................................................................... 9

3 Troubleshooting the RFID Reader...................................................11

3.1 Checking State of CWS ...............................................................................................................................113.2 Checking RFID Reader Connection (in Charging Base) .......................................................................113.3 Checking RFID Reader (in Charging Base)..............................................................................................113.4 Checking RFID Reader (out of Charging Base) ......................................................................................113.5 Determining if RFID Reader is in Sleep mode........................................................................................123.6 Determining if RFID Reader is Out of Range .........................................................................................123.7 Determining if RFID Reader is Paired with the CWS ............................................................................12

3.7.1 Pairing the RFID Reader...................................................................................................................133.7.2 Unpairing the RFID Reader .............................................................................................................15

3.8 Determining if the RFID Tag may be Defective.....................................................................................15

A Audio and Visual Feedback Indicators ...........................................17

B Prerequisites for RFID Reader.........................................................19

B.1 Charging the RFID Reader ..........................................................................................................................20

C Installation......................................................................................23

C.1 Tools Required...............................................................................................................................................23C.2 Installation.....................................................................................................................................................23C.3 Configuring CWS for the RFID Reader ....................................................................................................26C.4 System Setup .................................................................................................................................................27

D RFID Reader Battery........................................................................29

D.1 Replacing the Battery..................................................................................................................................29D.1.1 Tools Required ...................................................................................................................................29D.1.2 Replacing the Battery ......................................................................................................................29

D.2 Proper Disposal of Battery .........................................................................................................................32

E Cleaning the RFID Reader................................................................33

E.1 Cleaning the RFID Reader Window ..........................................................................................................33

ii RFID Contrast Identification Accessory for MEDRAD® Stellant Injection System with Certegra™ Workstation

E.2 Cleaning the RFID Reader Housing..........................................................................................................33

F Dimensions ......................................................................................35

G Environmental Specifications ........................................................37

G.1 Operating .......................................................................................................................................................37G.2 Non-operating (Transportation and Storage).......................................................................................37G.3 Wireless Communication ...........................................................................................................................37

H Replacement Parts List...................................................................39

Operation, Installation and Service Manual 1 - 1

1 Introduction

This document provides instructions on how to use the radio frequency identification (RFID) Contrast Identification Accessory (RFID Reader) for the MEDRAD® Stellant with Certegra™ Workstation (CWS). The RFID Reader is only to be used with the MEDRAD Stellant with CWS.

Use the RFID Reader to read the RFID tags on prefilled cartridges (CT - PFC) containing CT contrast media. The associated data (product name, concentration, volume, expiration date, lot/batch number) will be automatically transferred and displayed on the CWS Informatics panel.

NOTE: Bayer has certified RFID reading of prefilled CT cartridges for Iopamiron (Bayer), Omnipaque (Daiichi-Sankyo), and Iomeron (Eisai). Other contrast brands that may contain RFID tags are not certified to work with the current solution.

1.1 Intended Use

The RFID Reader is intended to automatically capture the information listed above from prefilled CT cartridges and transfer that information to the Certegra Workstation.

1.2 Certifications

The RFID Reader complies with IEC 60950-1 and Japan Radio Law. The RFID Reader is an approved accessory to the MEDRAD Stellant with CWS, which complies with IEC 60601-1.

The RFID Reader complies with part 15 of the FCC Rules. Operation is subject to the following two conditions:

1. This device may not cause harmful interference, and

2. This device must accept any interference received, including interference that may cause undesired operation.

Changes or modifications not expressly approved by the party responsible for compliance could void the user’s authority to operate the equipment.

NOTE: This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures:

QReorient or relocate the receiving antenna.

QIncrease the separation between the equipment and receiver.

QConnect the equipment into an outlet on a circuit different from that to which the receiver is connected.

QConsult the dealer or an experienced radio/TV technician for help.

CAUTION

Manually enter the proper Pressure Limit in order to avoid component damage and potential operator/patient injury. The RFID Reader does not read or transfer pressure limit from the RFID tag to the CWS.

1 - 2 RFID Contrast Identificatoin Accessory for MEDRAD® Stellant CT Injection System with Certegra™ Workstation

1.3 Contraindications

None known.

1.4 Required Training

This device is intended to be used by individuals with adequate training and experience in diagnostic imaging studies.

1.5 Symbols

Laser Light Do not stare into beamClass 2 Laser Product

MR-Unsafe: These are products which must not be used in an MRI environment.

Compliance Mark for Japan Radio Law.

Japan Automatic Identification System Association.

Recycle batteries following hospital protocols and local environmental regulations.

Indicates separate collection for Electrical and Electronic Equipment per Directive 2002/96/EC. Refer to the following website for additional information:www.weee.bayer.com

Dispose of batteries properly in accordance with hospital and local regulations. Do not incinerate.


1.6 Definition of Terms

NOTE: Indicates that the information that follows is additional important information or a tip that will help the user to recover from an error or point to related information within the manual.

1.7 System Configuration

Figure 1 - 1: Reading and Confirming RFID Information

WARNINGIndicates that the information is a warning. Warnings advise you of circumstances that could result in injury or death to the patient or operator. Read and understand the warnings before operating the injection system.

CAUTIONIndicates that the information is a caution. Cautions advise you of circumstances that could result in minor or moderate injury to the patient or operator. Read and understand the cautions before operating the injection system.


The RFID Reader is comprised of the following components:

Figure 1 - 2: RFID Reader and Charging Base attached to CWS

RFID Reader Charging Base attached to CWS

RFID Reader

Charging Pins

Pairing Barcode

Unpair Button

Light Emitting Diode (LED) Indicators

Primary Button

Charging Contacts


When reading qualified RFID tags, the RFID Reader will capture the following contrast information:

Q Product Name

Q Concentration

Q Volume

Q Expiration Date

Q Lot/Batch Number

Figure 1 - 3: Press “Fluids” to Review RFID Tag Information (see Figure 1-4)

Figure 1 - 4: Fluid Panel displaying RFID Tag Information

CAUTION

Manually enter the proper Pressure Limit in order to avoid component damage and potential operator/patient injury. The RFID Reader does not read or transfer pressure limit from the RFID tag to the CWS.


Figure 1 - 5: Data Confirmation displaying RFID Tag Information


2 Using the RFID Reader

The RFID Reader can be used both in the Control room and the Scanner room to capture and transfer CT contrast information to the CWS. The RFID Reader can stay in its Charging Base on the CWS, where it remains activated. The RFID Reader also works separately, away from the CWS.

NOTE: It is recommended that whenever the RFID Reader is not being used, it is placed in its Charging Base to maintain its battery charge.

2.1 Conditions for Valid RFID Reading

The RFID can read the RFID tag on the prefilled CT cartridge if the system is not engaged in arming, holding, or injecting. If the system is engaged in arming, holding, or injecting, the reading cannot be done until the activity is complete.

Figure 2 - 1: Home Screen


2.2 In the Charging Base

To use the RFID Reader stored in the Charging Base:

1. Make sure that the RFID Reader is active (green LED on) or charging (red and green LEDs alternating on).

NOTE: If the RFID Reader is not active, refer to subsections 3.2 and 3.3.

2. Hold the RFID tag for the disposable prefilled CT cartridge in front of the RFID Reader.

The device will emit an audible high-pitched beep and the green LED will flash. When the green LED flashes again and a second beep occurs, the RFID Reader has successfully transferred the fluid information to the CWS.

3. Check the Informatics panel on the CWS to confirm that the correct fluid information is displayed.

Figure 2 - 2: Transferring Fluid Information to CWS


2.3 Removed from Charging Base

To use the RFID Reader:

1. Remove the RFID Reader from its Charging Base.

NOTE: If the RFID Reader remains inactive for more than one minute, it will enter Sleep mode (green LED off). If this happens, press and release the primary button on the RFID Reader to activate it (wait to see that green LED is on). The RFID Reader will emit an audible ticking sound as it attempts to reconnect to the Charging Base, followed by three ascending beeps to indicate the connection is complete.

2. Hold the device next to the RFID tag of the disposable prefilled CT cartridge.

Important! Do not press the primary button on the RFID Reader while reading an RFID tag if the green LED is on. This action turns off the RFID reader and activates the laser.

The RFID Reader will emit a high-pitched beep and the green LED will flash. If this does not occur, hold the front of the RFID Reader against the RFID tag until it reads the data from the prefilled CT cartridge.

When the green LED flashes again and a second beep occurs, the RFID Reader has successfully transferred the fluid information to the CWS.

NOTE: If the RFID Reader is out of range of the Charging Base, it cannot transfer the fluid data to the CWS. The RFID Reader will emit an audible ticking sound, which will continue until the RFID Reader is within range (ticking sound is limited to one minute).

Figure 2 - 3: Fluid Information Displayed on CWS Informatics Panel

3. Check the Informatics panel on the CWS to confirm the correct fluid information is displayed.

NOTE: If the RFID does not read the RFID tag on the prefilled CT cartridge, check to see if the system is engaged in arming, holding, or injecting. If it is, the reading cannot be done until the activity is complete.

NOTE: When the RFID Reader is out of the Charging Base, it can hold a charge for four hours.


3 Troubleshooting the RFID Reader

If there is trouble with the RFID Reader, one of the following may be the cause.

Q The Charging Base is not properly connected to the CWS

Q The RFID Reader is not properly seated in the Charging Base

Q The RFID Reader is not charged

Q The RFID Reader is in sleep mode

Q The RFID Reader is out of range

Q The RFID Reader is not paired to the CWS

Q The RFID tag may be defective

3.1 Checking State of CWS

If the RFID does not read the RFID tag on the prefilled CT cartridge, check to see if the system is engaged in arming, holding, or injecting. If it is, the reading cannot be done until the activity is complete.

3.2 Checking RFID Reader Connection (in Charging Base)

To check the RFID Reader is properly connected to the CWS:

1. Verify the CWS is turned on (verify green light above Power button is on).

2. Verify the RFID Reader cable is properly plugged into the CWS USB port.

NOTE: The CWS may require rebooting at this point.

3.3 Checking RFID Reader (in Charging Base)

1. Verify the RFID Reader is seated properly in its Charging Base (at least one LED is on or flashing).

3.4 Checking RFID Reader (out of Charging Base)

To check that the RFID Reader is properly charged:

1. Verify the RFID Reader is active (green LED on).

NOTE: If the RFID Reader’s red LED is flashing, it indicates that the battery is low.


3.5 Determining if RFID Reader is in Sleep mode

If the RFID Reader is not in its Charging Base, it will automatically go into Sleep mode after one minute of inactivity. This is indicated by three distinctive beeps that change pitch from high to low, along with all LEDs turning off. If the RFID Reader is not in its Charging Base and no LEDs are on or flashing, it may be in Sleep mode.

To wake the RFID Reader from Sleep mode:

1. Press and release the RFID Reader’s primary button.

The red and green LEDs should flash at the same time, and the RFID Reader will emit an audible ticking noise, followed by three ascending beeps. The green LED will turn on.

Figure 3 - 1: RFID Reader Waking from Sleep Mode

NOTE: The RFID reader must be active (green LED on) to read a tag.

3.6 Determining if RFID Reader is Out of Range

The RFID Reader has wireless communication with its Charging Base, which provides a communication range of nine meters (30 ft.) of unobstructed free space between the RFID Reader and its Charging Base.

If an RFID tag is scanned while out-of-range, the RFID Reader will emit a high-pitched beep and the green LED will flash to indicate that the fluid data was captured, followed by an audible ticking noise to indicate that the RFID Reader is out-of-range.

Once the RFID Reader is in-range and active, the green LED will flash again and the RFID Reader will emit a second beep, confirming the RFID Reader has successfully transferred the fluid information to the CWS. If the RFID Reader is not returned to in-range within one minute, the RFID Reader will enter sleep mode and the fluid data will be lost.

3.7 Determining if RFID Reader is Paired with the CWS

If the RFID Reader is not paired correctly, it will not be able to transfer CT contrast fluid information to the CWS. When this happens, the RFID Reader will emit a low-pitched beep and the red LED will illuminate when trying to send information to the CWS.

To verify the RFID Reader is paired to the Charging Base, perform the following:

1. Remove the RFID Reader from the Charging Base and wait for the RFID Reader to enter sleep mode (all LEDs off).

2. Place the RFID Reader into the Charging Base.


Q If the RFID Reader responds with ticking following by the three ascending beeps, the RFID Reader is paired with that base.

Q If the RFID Reader responds with repeated ticking followed by a low beep and a red LED flash, the RFID Reader is not paired with the base.

3.7.1 Pairing the RFID Reader

NOTE: The RFID Reader uses wireless communication technology to communicate with its Charging Base. The RFID Reader will be paired with its Charging Base as part of the CWS installation and configuration.

Figure 3 - 2: Wireless Communication

Whenever the CWS is powered up, the Charging Base will automatically communicate with its RFID Reader. This is indicated by a steady ticking sound that ends with three ascending beeps to indicate that the pairing was successful.

As illustrated next, to manually pair the RFID Reader device with its Charging Base (post-installation, if needed):

1. Remove the RFID Reader from its Charging Base. Press and hold the unpair button on the Charging Base for three seconds.

Figure 3 - 3: Pressing and Holding Unpair Button

Press and Hold Unpair Button on Charging Base for Three Seconds


2. Press and hold the RFID Reader’s primary button to turn on the barcode laser and scan the pairing barcode located inside the Charging Base. The barcode laser will turn off when the pairing barcode is read. The device will emit a ticking sound. This indicates that the pairing process has started.

3. When the pairing process is complete, three ascending beeps occur. The RFID Reader can now be used with the paired Charging Base for the associated CWS.

Figure 3 - 4: Pairing the Charging Base with the RFID Reader

Press and Hold RFID Reader’s Primary Button


3.7.2 Unpairing the RFID Reader

The RFID Reader can be unpaired from its Charging Base by pressing and holding for three seconds the unpair button located inside the Charging Base. This action ends the wireless communication between the device and the Charging Base associated with the CWS.

Figure 3 - 5: Unpairing the RFID Reader

NOTE: It is not recommended to unpair an RFID Reader device from its Charging Base, as this will disable the functionality of the RFID Reader.

3.8 Determining if the RFID Tag may be Defective

The RFID Reader will emit a low-pitched beep and the red LED will flash to indicate there is an issue with reading the RFID tag. Alternatively, the RFID Reader may give no response if the RFID tag is defective.

To troubleshoot RFID tag function, read a second tag of the same product to see if the RFID Reader is able to read it properly.

Operation, Installation and Service Manual A - 17

A Audio and Visual Feedback Indicators

Refer to the table below for the various audio and visual feedback indicators used by the RFID Reader as part of its operation.

Meaning Tone LEDs

General

Power up - Red/GreenFlash once

Establishing wireless connection to base Ticking repeating every 0.5 second -

Successful connection to Charging Base Three ascending beeps Green Flash once

Unsuccessful connection to Charging Base Long low beep RedFlash once

Charging and ready to read RFID tag - Red/GreenFlash multiple times

Active and ready to read RFID tag - Green

Battery low - Red Flash multiple times

Entering sleep mode Three descending beeps -

Sleep mode or no power (depleted battery or base unpowered) - -

RFID Reading

Successful RFID read Short high beep Green Flash once

Successful fluid information display on CWS Long high beep Green Flash once

- Unsuccessful fluid information display on CWS- Unsuccessful connection to Charging Base- CWS not in “idle” state (see Section 2.1)

Long low beep RedFlash once

Wireless Connection


Successful wireless connection Three ascending beeps -

Unsuccessful wireless connection Long low beep RedFlash once

A - 18 RFID Contrast Identificatoin Accessory for MEDRAD® Stellant CT Injection System with Certegra™ Workstation

Base Pairing


Successful Charging Base pairing Three ascending beeps -

Unsuccessful Charging Base Pairing Long low beep RedFlash Once

Operation, Installation and Service Manual B - 19

B Prerequisites for RFID Reader

In order to use the RFID Reader with Certegra Workstation:

Q The physical CWS must be the model UTC515 (WCRU 84217204) with OS Image, Rev. B or higher

Q The CWS must have Certegra version 4.32 or higher, including the starter package

Q The Charging Base must be plugged into the CWS USB port

Q The Charging Base must be paired with the RFID Reader

Q The RFID Reader must be charged

Figure B - 1: CWS Home Screen

B - 20 RFID Contrast Identificatoin Accessory for MEDRAD® Stellant CT Injection System with Certegra™ Workstation

B.1 Charging the RFID Reader

Make sure the RFID Reader base cable is plugged into the CWS USB port (located on the back of the display) as shown in Figure B-2.

Figure B - 2: CWS Rear Panel

NOTE: Be sure to only charge the RFID Reader with the provided RFID Charging Base. In addition, do not use the provided RFID Charging Base to charge any other device.

NOTE: A flashing red LED on the RFID Reader indicates a low battery. Place the RFID Reader in the USB-connected Charging Base to re-charge. While charging and ready to scan, the RFID Reader’s red and green LEDs flash alternately. When charging is complete, the RFID Reader’s green LED stays lit.

Installation and Service of RFID Reader

Operation, Installation and Service Manual C - 23

C Installation

C.1 Tools Required

Q #2 Phillips head screwdriver

C.2 Installation

1. The following instructions describe mounting the RFID Reader bracket on the right-hand side of the workstation. If it is desired to mount the assembly on the left-hand side of the workstation, disassemble the bracket by removing the two screws. This will separate the L-bracket component from the V-bracket component. Turn the L-bracket component over to mount on the right-hand side of the V-bracket component. Insert the two screws and tighten. This will permit mounting the bracket on the left-hand side of the workstation.

2. Loosen the two Charging Base mounting pin screws from the rear of the bracket.

Figure C - 1: Two Charging Base Mounting Pin Screws

3. Locate the Charging Base keyholes over the mounting pins on the bracket.

Charging Base Mounting Pins

C - 24 RFID Contrast Identificatoin Accessory for MEDRAD® Stellant CT Injection System with Certegra™ Workstation

4. Push the Charging Base down toward the front of the bracket until it snaps into place. The front edge of the Charging Base should be even with the edge of the bracket.

Figure C - 2: Snapping Charging Base onto Bracket

5. Tighten the two screws on the rear of the bracket until snug.

6. Locate the slot in the side of the display.

Figure C - 3: Slot on Side of Display

Slot


7. Align the mounting pins vertically so that they will slide into the slot. Position the bracket and Charging Base at a desired height on the side of the display.

Figure C - 4: Aligning Mounting Pins with Display Slot

8. Tighten the two screws on the bracket to hold the bracket and Charging Base in place.

Figure C - 5: Tightening Screws to Hold Bracket and Charging Base in Place

9. Remove the connector access panel on the rear of the display by removing the two screws and lifting the panel off the display.

10. Insert the USB connector from the Charging Base interface cable into one of the open USB ports.

11. Replace the connector access panel and install the two screws.

Screws


12. When the base is connected, place the RFID Reader into the base to charge the battery.

Figure C - 6: Charging Base Connected to Display

13. Power on the workstation.

14. The RFID Reader’s indicator LEDs flash, alternating between the green and red LED, to indicate the battery is charging. If only the green LED is lit, the unit is fully charged. If only the red LED is flashing, the unit is charging but the voltage/charge is too low to allow operation and charging simultaneously. Please wait until the LEDs alternate between red and green before attempting to use while in the base.

C.3 Configuring CWS for the RFID Reader

To make sure the RFID Reader is enabled, follow these steps:

1. Using the service laptop computer, remotely connect to the MEDRAD Stellant with CWS.

2. Open the Certegra Home Web page.

3. Select Configuration.

4. Scroll down to Enhanced Identification (barcode/RFID Reader).

5. Select Enable.

6. Scroll to the bottom of the page and click on Apply Changes.

7. Disconnect the laptop computer from the CWS. Power down and then restart the CWS system.


C.4 System Setup

1. When the battery in the RFID Reader has sufficient charge, the system setup can be performed.

2. Whenever the CWS is powered up, the RFID Reader Charging Base will automatically connect with the RFID Reader in the Charging Base. This is indicated by a steady ticking sound that ends with three ascending beeps to indicate that the connection was successful.

NOTE: If the RFID Reader responds with continued ticking and ending with a low beep tone and red LED flash, the RFID Reader may not be properly paired with the base. See Section 3.7.1 for pairing instructions.

3. With the battery fully charged the green LED should be illuminated. Up to four hours may be required to fully charge the battery.

4. Place an RFID tag in front of the RFID Reader. (This may be performed while the unit is charging.)

5. There will be a high-pitched beep and the green LED will flash. When the green LED flashes again and a second beep occurs, the RFID Reader has successfully transferred the fluid information to the CWS.

6. Check the Informatics panel FLUIDS section on the CWS to ensure the correct fluid information is displayed.

Operation, Installation and Service Manual D - 29

D RFID Reader Battery

The RFID Reader is powered by a lithium-ion battery. A new battery at full charge should allow operation for a full eight-hour shift given a typical use case of RFID scanning four times per hour.

Recharging a fully discharged battery will take three to four hours, depending on the level of use (scanning) while in the base.

D.1 Replacing the Battery

NOTE: The battery is only partially charged when received. When the replacement is completed it will be necessary to leave the battery in the Charging Base to fully charge the battery.

D.1.1 Tools Required

Q Small flat blade screwdriver

D.1.2 Replacing the Battery

1. Remove the two screws on the rear of the RFID Reader.

Figure D - 1: Battery Screws and Connector

2. Lift the rear cover and gasket off the RFID Reader.

3. Remove the Kapton® tape and set aside.

CAUTIONS

Q Battery replacement should only be performed by qualified personnel such as Bayer Service Personnel or system owner biomedical engineers/technicians. Improper replacement may result in property damage or personal injury.

Q To avoid risk of explosion, always use approved replacement batteries.

Q Do not disassemble the battery. There are no user-serviceable parts in the battery.

Q Do not short-circuit a battery or throw it into a fire. It can explode and cause severe personal injury.

Screws

Connector

D - 30 RFID Contrast Identificatoin Accessory for MEDRAD® Stellant CT Injection System with Certegra™ Workstation

4. Disconnect the battery from the printed circuit board by prying the connector from its socket using a small screwdriver, as shown in the next photo.

Figure D - 2: Prying Connector from Socket

5. Gently remove the battery assembly from the RFID Reader. Do not pull on the wires to remove the battery.

Figure D - 3: Removing Battery Assembly from RFID Reader

6. If not already installed on the new battery, place two Poron® pads lengthwise along the edge of the battery next to the cable.

Figure D - 4: Battery with and without Poron pads (pads shown in center photo)

Operation, Installation and Service Manual D - 31

7. Insert the battery installation fixture into the unit so it is sitting on the top side of the board where the internal Poron pads are located.

Figure D - 5: Inserting Battery Installation Fixture into Unit

8. Gently insert the battery along the side rails of the unit, with the battery label facing up. Ensure the Poron pads are not being pried away from the board on which the battery rests.

9. Gently remove the battery installation fixture after the battery has been installed into the housing. Verify the Poron pads were not damaged.

10. Plug the battery cable into the white connector of the board, as shown in Figure D-6.

NOTE: When properly connected, the red wire will face to the right, as shown in Figure D-6.

Figure D - 6: Battery Cable plugged into White Connector

11. Gently fold the red and black wires so they rest neatly on the Poron pads. DO NOT TUCK the wires in between the battery and the board. MAKE SURE the wires ARE NOT touching the silver USB connector on the board.

Figure D - 7: Proper Placement of Red and Black Wires

Set fixture over pad

D - 32 RFID Contrast Identificatoin Accessory for MEDRAD® Stellant CT Injection System with Certegra™ Workstation

12. Attach a piece of anti-static Kapton tape (provided) over the wires and Poron pads on the battery installation fixture. If no tape is provided, reuse that tape previously removed.

Figure D - 8: Anti-static Kapton Tape Applied

13. Re-install the battery cover, gasket, and screws. Ensure the battery cable is not extending into the outer edges where the battery cover sets. Be careful to not over tighten the screws.

Figure D - 9: Battery Cover

14. Verify the battery cover is properly and securely placed back onto the unit, as shown in Figure D-10.

Figure D - 10: Battery Cover Securely in Place

15. Install the RFID Reader in the charger base to complete the battery charging.

D.2 Proper Disposal of Battery

When the battery has reached the end of its useful life, the battery should be disposed of by a qualified recycler or hazardous materials handler. Do not incinerate the battery or dispose of the battery with general waste materials. Follow the local regulations.

Operation, Installation and Service Manual E - 33

E Cleaning the RFID Reader

E.1 Cleaning the RFID Reader Window

Clean the RFID Reader’s window with a soft cloth or lens tissue dampened with water (or a mild detergent/water solution). If a detergent solution is used, rinse with a clean lens tissue dampened with water only.

E.2 Cleaning the RFID Reader Housing

Care must be taken not to get water or cleaning solutions inside any of the system components. Clean the RFID Reader’s housing with a soft non-abrasive cloth, warm water, and a mild detergent or a mild disinfectant, such as hydrogen peroxide or isopropyl alcohol. Do not use strong cleaning agents or solvents.

E - 34 RFID Contrast Identificatoin Accessory for MEDRAD® Stellant CT Injection System with Certegra™ Workstation

Operation, Installation and Service Manual F - 35

F Dimensions

Figure F - 1: Dimensions of RFID Reader

Figure F - 2: Dimensions of Charging Base

5.53 in14.04 cm

2.00 in5.07 cm

1.28 in3.26 cm

Weight is 4.2 Oz.

5.81 in14.75 cm

2.37 in6.03 cm

2.19 in5.55 cm

Weight with cable is 4.3 Oz.

F - 36 RFID Contrast Identificatoin Accessory for MEDRAD® Stellant CT Injection System with Certegra™ Workstation

Figure F - 3: Dimensions of RFID Reader and Charging Base Combined

5.81 in14.75 cm

2.37 in6.03 cm

2.19 in5.55 cm

Operation, Installation and Service Manual G - 37

G Environmental Specifications

G.1 Operating

Temperature: 10 to 40 degrees C (inclusive)

Humidity: 20 to 90 percent (inclusive), non-condensing

Air Pressure: 69 to 105 kPa (inclusive)

G.2 Non-operating (Transportation and Storage)

Temperature: -20 to 60 degrees C (inclusive)

Humidity: 5 to 100 percent (inclusive), non-condensing

Air Pressure: 57 to 106 kPa (inclusive)

G.3 Wireless Communication

Radio: Bluetooth® v2.1

Frequency: 2.402 to 2.480 MHz

G - 38 RFID Contrast Identificatoin Accessory for MEDRAD® Stellant CT Injection System with Certegra™ Workstation

Operation, Installation and Service Manual H - 39

H Replacement Parts List

* The terms “EID” and “handheld” refer to the RFID Reader.

RFID Reader Part Numbers

Description* Part Number

1 Kit, EID, Certegra 84657778

2 EID, Certegra 84654892

3 Battery, EID, Certegra 84842508

4 Assembly, Bracket, EID, Certegra 84662836

5 Ops Manual, EID, Certegra, EN 84662917

6 Ops Manual, EID, Certegra, JP 84662895

7 EID, RFID Quick Guide 84662720

H - 40 RFID Contrast Identificatoin Accessory for MEDRAD® Stellant CT Injection System with Certegra™ Workstation

1 - ii MEDRAD® <ADD-PRODUCT>

ManufacturerBayer Medical Care Inc.1 Bayer DriveIndianola, PA 15051U.S.A.Phone: +1-412-767-2400

+1-800-633-7231Fax: +1-412-767-4120

Authorized EuropeanRepresentativeBayer Medical Care B.V.Horsterweg 246199 Maastricht AirportThe NetherlandsPhone: +31(0)43-3585601Fax: +31(0)43-3656598

Authorized JapaneseRepresentative

530-00012-4-9

:+81(0) 6-6133-6250Fax: +81(0) 6-6344-2395

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Bayer reserves the right to modify the specifications and features described herein or to discontinue any product or service identified in this publication at any time without prior notice or obligation. Please contact your authorized representative from Bayer for the most current information.

All patient data that appear in this document are fictitious. No actual patient information is shown.

Bayer, the Bayer Cross, MEDRAD, Stellant, MEDRAD Stellant and Certegra are trademarks owned by and/or registered to Bayer in the U.S. and/or other countries. Other trademarks and company names mentioned herein are properties of their respective owners and are used herein solely for informational purposes. No relationship or endorsement should be inferred or implied.

© 2015-2017 Bayer. This material may not be reproduced, displayed, modified or distributed without the express prior written consent of Bayer.

84662917 Rev. G October 4, 2017

i Operation, Installation and Service Manual

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