4535 679 62381 Rev B

4535 679 62381 Rev B

Philips Medical Systems (Cleveland), Inc. Nuclear Medicine 595 Miner Road Cleveland, Ohio 44143, U.S.A.

TITLE: GEMINI GXL SITE PLANNING GUIDE

AUTHOR: Ken Hrovat DATE: 06/08/05

APPROVED BY: DATE:

ABSTRACT: The Philips GEMINI PET/CT Imaging Systems are a family of

integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) systems suitable for a wide range of diagnostic applications. This site Planning guide details siting specifications intended specifically for the Gemini GXL with 16 slice CT system referred to as the Gemini GXL system.

REVISION HISTORY

Rev Date Control No. Author Comment 01 06/03/04 Jeff Marini Initial Draft 02 10/20/04 Jeff Marini 2nd Draft 03 11/30/04 Jeff Marini 3rd Draft 03a 05/31/05 Ken Hrovat 3rd Draft A 06/08/05 Ken Hrovat Released

B 09/12/05 2011922 Ken Hrovat Revised - See page 4 for changes

PHILIPS MEDICAL SYSTEMS 4535 679 62381 Rev B

©Philips Medical Systems (Cleveland) Inc. 2005, Cleveland, Ohio, proprietary and confidential information, refer to front page

©Philips Medical Systems (Cleveland) Inc. 2005 Unpublished work - All rights reserved under the copyright laws of the United States

all pages of this document contain proprietary and confidential information of Philips Medical Systems (Cleveland), Inc. and are intended for exclusive use by current Philips personnel. Copying, disclosure to others or other use is prohibited without the express

written authorization of Philips Law Department. Report violations of this requirement to the Philips Law Department, Cleveland, Ohio 44143 U.S.A.

SECTION I…INTRODUCTION

SECTION II…GENERAL REQUIREMENTS SECTION III…ROOM LAYOUTS SECTION IV…FLOOR LOADING SECTION V…FLOOR AND ANCHOR DETAILS SECTION VI…NETWORKING SECTION VII…SHIPPING INFORMATION SECTION VIII…RADIATION SAFETY



FORWARD:

The site selection process is the first step in acquiring any PET/CT imaging system. Careful planning during this initial stage is essential to long term success of your PET/CT imaging program. As an aid in selecting a proper site, Philips Medical Systems has prepared this Site Planning Guide. The information presented in this guide will assist in planning a site for the Gemini GXL PET/ CT system. Key specifications that would affect the physical layout of the facility are indicated. Use the ‘Recommended’ and ‘Minimum’ layouts to visualize how the system would fit into any existing room configuration. The information provided in this guide should be used only as a “rough guideline” to support you during the initial stage of your site selection. The siting of a Philips Medical PET/ CT system requires the analysis of many factors that can directly impact site construction, installation and final image quality. Therefore, it is essential to obtain a detailed analysis of all architectural, electrical, mechanical, environmental and in some cases, geographical factors and occurrences. Philips Medical Systems will supply site planning assistance for all phases of design and planning which will include a proposed equipment layout of the customer’s site, based on information provided by the customer. After the proposed layout has been approved, Philips Site planning will develop a final installation drawing for each site.

DISCLAIMER:

The information and drawings set forth in this document and all rights in and to inventions disclosed herein and patents which might be granted thereon disclosing or employing the materials, methods, techniques or apparatus described herein are the exclusive property of Philips Medical Systems. Further, Philips Medical Systems reserves the right to revise this publication and to make changes from time to time in the content hereof without obligation of Philips Medical Systems to notify any person or organization of such revision or changes. This document is protected by copyright’. No copies of this information or drawings shall be made without the prior consent of Philips Medical Systems.



Rev Revised by Revision Date Description of Changes 01 Jeff Marini 06/03/04 Initial Draft

02 Jeff Marini 10/20/04 2nd Draft Revised ‘Radiation Safety Section’

03 Jeff Marini 11/30/04 3rd Draft xxxxxxxxxxxxxxxxxxxxxxx

03a Ken Hrovat 05/31/05

3rd Draft Revised: General Requirements, Power Quality Requirements, Power Closet / Environmental Requirements and Floor Loading

A Ken Hrovat 06/08/05 Released

B Ken Hrovat 09/12/05

Revised Section 3: fig.3-3 Sys. Patient Environmental Area, Preferred Junction Box Layout, Power Quality Requirements, Incoming Power Schematic. Section 8: Radiation Safety, Radioactive Sources.



SECTION 1

INTRODUCTION SCOPE:

This manual describes site selection procedures for the Gemini GXL System. The following recommended specifications are described:

• General Requirements (Section II) • Room Layouts (Section III) • Floor Loading (Section IV) • Floor and Anchor Details (Section V) • Networking (Section VI) • Shipping Information (Section VII)

• Radiation Safety (Section VIII)



General Information The Gemini GXL system is a hybrid PET/CT system, capable of performing sequential PET and CT studies on a patient, while keeping the patient relatively motion free on an integral patient table. Images thus obtained may be later viewed as fused multi-modality images with both anatomical and functional information over layed. The system uses the Philips- Guardian-PET system and the Philips 16 Power CT. A drive and alignment system will allow the PET portion of Gemini to be moved rearward to allow unobstructed CT imaging. Figure 1.1 below, is a photograph of the Gemini GXL System.

Figure 1.1

Gantry The gantry is a 2-part unit, with the front “lobe” of the gantry housing the CT unit, and the rear housing the PET. There is a patient access port between the lobes of the system, which allows interaction between the attending technician or physician and the patient as well as providing a more open, less threatening experience for the patient. The PET portion of the gantry is actuated in the patient axial direction by a separation mechanism, which allows rearward motion of the PET system by a distance of not more than 60.1cm. Gantry controls are located on the front face of the CT and PET, with the exception of the separation switches, which are located on either side of the CT system.

Table

The couch system is a cantilevered unit that utilizes a vertically actuated patient support located in front of the system, a two stage, horizontally actuated pallet system that allows imaging in either the CT or the PET lobes of the system, and an inbore vertically actuated lifter for providing additional support to the pallet system when in the PET imaging position.

Operator’s Console

The operator’s console is, for reasons of radiation safety for the operator, located in an adjoining room, which must have a leaded glass viewport so that visual contact by the operator of the patient may be maintained. The standard operator’s console consists of two workstations, the PET reconstruction and display console and the CT display and processing console.



SECTION II

GENERAL REQUIREMENTS

The following table reflects important site selection information:

Exam Room Recommended 26’-0”L x16’-0”W (7925mm) L x (4877mm) W

Control/ Equipment Room Recommended 12’-0”L x16’-0”W (3657mm) L x (4877mm) W

Exam Room Minimum 24’-0”L x14’-0”W (7315mm) L x (4267mm) W

Control Room Minimum 8’-0”L x14’-0”W (2438mm) L x (4267mm) W

Scanner Dimensions 20’-1”L X 6’-10 ½”W (6121mm) L x (2095mm) W

Total System Weight (exam room components)

Approx. 8,475lbs. (3844kg) (excluding recon cabinet and power regulating devices)

Temperature Requirements 18-24C (64-75F) -temperature changes must not exceed 5 degrees F (3 degrees C) per hour

Humidity Requirements 30%-60% non-condensing

Heat Load: Exam room

Heat Load: Control Room

Approx. 26,000 btu/hr (20,000-CT / 6,000- PET)

Approx. 4,000 btu/hr (Pet and CT workstations + misc.)

Note 1: Add 5,300 btu/hr for Recon Cabinet Note 2: does not include power regulating devices

Floor Loading Unless the floor is reinforced concrete slab poured on grade, a Licensed structural Engineer must evaluate the floor capacity

Power Requirements: Mains Type:

Voltage:

Frequency:

Voltage Regulation:

Distribution Transformer:

Three Phase

480 VAC rms, nominal

50 or 60 Hz, nominal

± 10% Total

100 KVA, minimum

Shielding Requirements Must be determined by Radiation Supervisor/ Safety Officer.

Modem Line Dedicated analog telephone line required for remote support

Radioactivity License Requirements

F-18 – Amount as required for patient doses

Na-22 – 100µCi; IPL#GF-0227 Na-22 – 10µCi; IPL#MMS05-22-10U (Quantity 6)

Environmental Requirement The magnetic field may not exceed 1.0 Gauss at any point on the system.



SECTION III

ROOM LAYOUTS ROOM SIZE REQUIREMENTS Recommended Room Sizes Exam Room 26’-0” [7930mm] W x 16’-0” [4880mm] D Control Room/ Equip. Room 12’-0” [3660mm] W x 16’-0” [4880mm] D Minimum Room Sizes Exam Room 24’-0” [7320mm] W x 14’-0” [4270mm] D Control Room 8’-0” [2440mm] W x 14’-0” [4270mm] D

NOTE: Minimum Finished Ceiling Height is 8’-0” (2440mm) NOTE: The minimum exam room width was calculated allowing 3’-0” (910mm) on back side of system for service and 4’-0” (1220mm) on front side of system for gurney access.

Figure 3-1. Illustrates a recommended room layout size. (note: equipment closet shown mainly for size requirements. Preferred location is outside of Gemini suite.

Figure 3-2. Illustrates minimum room layout size.

• A separate Operator Station is recommended in the interest of reducing radiation exposure to the operator.

• A separate Equipment room is shown off of the control room (fig.3-1) for the power-conditioning unit.

Figure 3-3. Illustrates minimum system patient environment area.

• Non-IEC 60601 devices must be located outside the area as shown in this diagram.

RADIATION CONSIDERATIONS The isotopes used in Gemini GXL emit higher energy radiation than the isotopes used in single photon imaging - 511 keV vs. 140 keV for Tc-99m. This means that special care must be taken in the layout of the Gemini GXL suite.

INJECTION AND WAITING ROOM

A separate injection/waiting room is recommended. This room should be located so that the radiation from patients injected with FDG will not affect nearby gamma cameras. If the walls between the injection/waiting area and the Scanner Room are not shielded, the rooms should be planned so that



the injected patient is kept at least 30 ft [9 m] from the isocenter of the Scanner. This will ensure that the background radiation from the injected patient does not interfere with the operation of the Gemini.



POWER QUALITY REQUIREMENTS GEMINI SYSTEM

For further requirements see Gemini PET/CT Power Requirements 4535 671 41651

Mains Supply Supply configurations : 3 phase Y, 3 wires and Earth 1 & 2 (L1, L2, L3, PE, APE) for

Scanner Mains resistance : 200 m/Ohm line to line, max. Mains fuse (standards) : 100 A slow/fast Measured current (inrush, standby, maximum)

: Inrush 120 Amps Standby 8 Amps, 3 phase average Maximum 82 Amps (60kW scan @ 480 VAC, 0.95 PF) 10 sec.

Voltage variation : +10 %, -10 % total (absolute) limits Voltage impulse : +/- 2kV per IEC 61000-4-4 Voltage surge : +/- 2kV per IEC 61000-4-5 Voltage sag : 90%, 1 cycle, 3 sec. Static frequency variation : +/-3 Hz Dynamic frequency variation : N/A Hz/min Harmonic voltage distortion (total) : 10 % max. THDv The main power wires run in a supplied 1 5/8” (41mm) flexible hose (maximum cable length 25’-0” (7620mm) from the rear of the gantry separation unit to the main disconnect switch. This hose may be encased in ducting or a 2” (50mm) c depending on room conditions. QUALITY SYSTEM Branch power recommended : 112.5 KVA Maximum power required : 80 KVA Nominal input power : 480 VAC,+10% - 10% total (absolute) limits Line frequency range : 47 to 63 Hz Room disconnect/ circuit breaker : 100 Amps Phase to phase imbalance : 5% Max. load voltage drop range : 432 to 528 VAC total (absolute) limits Load voltage regulation : 5% Voltage drop allowed in cable : 1% Instantaneous current : 120 Amps Voltage drop in cable : 4.8 VAC Conductor impedance : Based on 1% cable voltage drop, copper wires in steel conduit Power factor : 0.85 min. PF



Note: Required nominal input voltage to the CT gantry is 480 VAC from the building facility supply or an additional power protection device and must meet the specifications described above. For power protection/ conditioning devices approved and available from Philips, see Section 6.4. The SSR/SSD must determine and select the proper power protection unit, in order to meet the needs of the facility for optimum and reliable operation of the CT system. Refer to appropriate Philips SSR equipment price pages for all power protection device part numbers and availability for delivery. The PET/CT family of scanners has been designed and tested to meet the following international requirements for immunity to power line disturbances. Customer sites that exceed these levels require additional input power conditioning, for reliable and continuous scanner operation. In situations where such adverse conditions persist an Un-interruptible Power Supply, (UPS) will be required. Run distances and cable/ conductor sizes from Distribution Source or Power Unit to Room Main Disconnect/ Circuit Breaker or Fuse is based on 480 VAC. Wire size for other voltages is determined by calculating size required for 1% voltage drop at 80 KVA (than maybe consult factory if assistance is required). 0 – 50 Ft (15240mm) : 4 #2 (35 mm2) Power & Isolated Ground (PE) 51 –100 Ft. (30480mm) : 4 #1 (50 mm2) Power & Isolated Ground (PE) 101– 200 Ft. (60960mm) : 4 #00 (70 mm2) Power & Isolated Ground (PE) Note: One # 8 Redundant Ground (APE) required from system disconnect to Teal or UPS Ground. Run distances and cable/ conductor sizes from Room Disconnect/ Circuit Breaker or Fuse to CT Scanner Gantry based on 480 VAC load side. 0 – 25Ft. (7620mm) : 4 #2 (34 mm2) Power & Isolated Ground (PE)

1 #8 (6 mm2) Redundant Isolated Ground (APE) Note: All of the above conductors include dedicated (earth) ground wire. To be same size as power conductors.

Power Box Descriptions Main Disconnect: 600V, 3 phase, 3 pole, w/ 100A breaker Note: Circuit breaker used shall be UL listed or recognized, rated maximum 100A; to ensure compliance to IEC 60328, verify that circuit breaker is not marked with a greek symbol, and look for VDE, TUV, NEMKO, SEMKO, DEMKO or FIMKO certification mark. Remote on / off switch: 120V, single phase



POWER CLOSET/ ENVIRONMENTAL REQUIREMENTS

The following table reflects important information related to environmental requirements For a gantry power conditioner and/ or gantry UPS.

Power closet recommended minimum * 4’-0” x 10’-0” (1220mm) x 3050mm) Unrestricted access to UPS cabinets (front: 12” (300mm) one side: 36” (910mm) Total system weight Approx. 4,000 lbs. (1814kg) (battery and elec.

Cabinet) Temperature requirements 85 F (30 C) maximum Humidity requirements 5% - 95% non-condensing Heat load 5,500 btu/hr (typical) Audible noise < 65 dBA @ 1 meter Floor loading Unless the floor is reinforced concrete slab on

grade, a licensed structural engineer must evaluate the floor capacity

Power requirements to UPS Mains type:

Voltage:

Frequency: Distribution transformer:

Three phase Delta plus protective earth 480V nominal VAC rms (other voltage configurations available as req.) 50 or 60 Hz, nominal 100 KVA, minimum

* It is required that the power conditioner and UPS be located in an environmentally controlled equipment closet. Recommended location is in an area outside of the Gemini suite.

The following table reflects important information related to environmental requirements

For gantry isolation transformer.

Cable entry/ exit Rear Total system weight Approx. 697lbs. (317kg) Temperature requirements 100 F (38 C) maximum Humidity requirements 5% - 95% non-condensing Heat load 1950 btu/hr (typical) Audible noise < 50 dBA @ 1 meter Power requirements

Mains type:Voltage:

Frequency:

Three phase Delta plus protective earth 200V – 500V 50 or 60 Hz, nominal



SECTION IV

FLOOR LOADING GENERAL FLOOR LOADING INFORMATION

Important: Unless the floor is a reinforced concrete slab poured on grade, a licensed structural engineer must evaluate the floor loading capacity.

The below numbers summarize the floor loads that this section describes in detail.

Approximate Equipment Weights: exam room C.T. Gantry: 4,200lbs. [1905kg] PET Gantry: 2,500lbs. [1134kg] Patient Table: 1,250lbs. [567kg] Separation unit; 425lbs. [193kg] Inbore Lifter; 100lbs. [45kg] Total: 8,475lbs. [3844kg] Minimum room size= 336sq.ft. [30sq.m.]

8,475lbs.[3844kg] divided by: 336sq.ft [30sq.m.] = 25.22lbs/ sq.ft. [128.1kg/ sq.m.] NOTE: Above calculations do not include a power conditioning or regulating device In the exam room; Power conditioner: 720lbs [326kg] (typical) Power regulator with UPS: 4,000lbs [1814kg] (typical) Line Matching Transformer: for 50HZ sites only w/ ups approx.600lbs [272kg] (typical)



SECTION V

FLOOR AND ANCHOR DETAILS

The Gemini GXL baseplate must be leveled and bolted to the floor. If the floor is concrete of sufficient thickness, use the anchors supplied. In all other cases, the baseplate should be through-bolted to the floor based on the site engineer of record requirements.

The Gemini GXL baseplate may be mounted on an existing floor covering. It is important that the customer provide a surface that shall be flat and level to within 1/2” along the entire length and width of the system, see “Floor Levelness Detail” Figure 5.3 for requirements. An epoxy base will be poured under the CSU and Patient Table after leveling. This procedure will be the responsibility of the Philips installation team.

• For mounting hole locations see fiqure 5.1 “Gemini GXL Baseplate Detail”.

NOTE: If the Gemini GXL System is installed in an area of seismic risk, no additional mounting hardware is required. See manufacturer for all siting specifications for optional laser light system installation.

• For laser centerline positioning see fiqure 5.2 “Gemini GXL Lap Laser Centerline Location”.



SECTION VI

NETWORKING

The Gemini GXL standard system configuration is a standalone system, which can be easily modified for networking and remote access, see networking diagram. The system consists of two workstations located in the control room. The workstations assemblies consist of the acquisition workstations for both PET and C.T.

NETWORKED CONFIGURATION WITH REMOTE WORKSTATION

Remote workstation is the term used for additional workstations connected to the Gemini GXL networked system configuration. The remote workstation, also referred to as the “doctors remote viewing station”, consists of a workstation and a monitor. The Gemini GXL system is capable of hosting multiple remote workstations. Remote workstations can only interface with one Gemini GXL system.



SECTION VII

SHIPPING INFORMATION

Both gantries of the Gemini GXL system require a minimum 48” (1220MM) door opening to pass straight through the doorway. Overall system height is 81”(2060mm). Passage under a standard 80” (2030mm) door will require that the gantry covers be removed. Refer to figure 7.1 for dolly dimensions. If required, it is possible to remove one roller lift in order to fit each gantry into an elevator. See “CT Minimum Door Height Analysis Detail” for gantry clearance under doorways. It is also possible to to reduce the overall length of each gantry by using platform dollies underneath the gantry rather than roller lifts at the ends. However, this will increase the gantry height. It is also possible to shorten the length of the patient support in order to fit it into a standard elevator. The length of the patient support may be shortened to 93” (2362mm) by using a special tilting dolly.

• For gantry access into exam room see Figure 7.1 “CT Gantry Passageway Detail”. • For minimizing the length of the Patient Support see; “Patient Support

Transporting Detail”.

SHIPPING SIZES AND WEIGHTS (3 LARGEST COMPONENTS)

ITEM WIDTH DEPTH HEIGHT WEIGHT C.T. GANTRY 109” 36 5/8” 79 5/8” 4,500 LBS (on dollies, covers off) (3025mm) (932mm) (2022mm) (2038kg) PET GANTRY 106 ½” 29 1/2" 69” 2,500 LBS (on dollies, covers off) (2705mm) (750mm) (1750mm) (1133kg) PATIENT SUPPORT 107” 35” 28” 1,250 LBS (not tilted) (2720mm) (890mm) (710mm) (567kg)



SECTION VIII

RADIATION SAFETY RADIOACTIVE SOURCES The Gemini GXL system requires seven radioactive sources:

1. (7) Na-22 quality control and calibration sources

1.1 Only ILP sources are acceptable. For domestic shipments, the sources are drop-shipped from the source vendor, Isotope Product Laboratories (IPL). For export, the sources must be purchased separately from ILP local distributor. Ordering information is provided at the time of sale. Source Characteristics

ITEM NA-22 SOURCE NA-22 SOURCE Activity (nominal) 3.7MBq (100µCi) .37MBq (10µCi) Manufacturer Isotope Product

Laboratories (IPL) Isotope Product Laboratories (IPL)

IPL model number GF-0227 100µCi MMS05-22-10U Quantity 1 6 Sealed source and device registry

CA0406S1060S NUREG 1556 section 5.11(see note 1, page 34)

APPLICABLE REGULATIONS Radiation safety considerations in the design of the Gemini GXL are driven by US Nuclear Regulatory Commission (NRC), and Agreements States, regulations and guides. The NRC specifies that the maximum dose of radiation permitted for workers in the United States is 5000 Mrem per year (NRC Title 10 Part 20). This corresponds to an average dose of approximately 2.5 mrem/ hour. Note that for gamma radiation, 1mrem = 1mR = 1mrad = 10uSv. The NRC also recommends the adoption of “ALARA – As Low As Reasonably Achievable” as the operating policy of radiation safety programs.



RADIATION CONSIDERATIONS The isotopes used in Gemini GXL emit a higher energy radiation than the isotopes typically used in single photon imaging – 511keV vs. 140keV for Tc-99m. This means that special care must be taken in the layout of the Gemini GXL suite. The Gemini GXL exam room should be close to the radio pharmaceutical dispensing area and a patient waiting area. The patient waiting area is a room where the patient can wait during the uptake period, i.e. after the activity has been injected and before imaging begins. These three areas should be a reasonable distance from the offices and Nuclear medicine scanning rooms. In order to preserve optimal imaging operation, the Gemini GXL system should not be exposed to external F18 dose rates in excess of 0.3mr/hr measured at 1 meter from the gantry. The Radioactive Materials License Holder should consult the site’s Radiation Safety Officer (RSO) to define proper radiation safety requirements and procedures. RADIOACTIVE MATERIALS LICENSE Procurement of a radioactive materials license or license amendment is often the critical item in the site preparation process. The scanner cannot be installed unless the site is properly licensed. The application process can be very time-consuming., so the process should begin early. In the United States, the State is the licensing authority for Na-22 and F-18. The customer must have the proper license in order for Philips Medical Systems to authorize the source vendor to ship the radioactive sources for the scanner. The scanner cannot be installed until the licenses have been obtained. SOURCE DISPOSAL The manufacturer of the Cs-137 and Na-22 sources, Isotope Product Laboratories, will accept the return of these sources at any time for a fee.



NOTES: 1.) NUREG-1556, Section 5.1.1 Calibration and Reference Standards’ reads; Calibration and reference sources may be licensed without evaluation review by IMNS if the sources do not exceed the following;

• For beta and/ or gamma emitting material – 3.7MBq (100uCi) or ten times the quantity specified in section 30.71 Schedule B, 10 CFR 30, whichever is greater

• For alpha emitting material – 0.37 MBq (10uCi)

General Note: Source values were chosen because they represent minimal hazard to public health and safety. To license these sources, license reviewers need to identify the isotope in item 6 of the materials license, use the statement “calibration or reference sources” in item 7, and state the maximum quantity for each source in item 8. Both possession and distribution to specific licenses may be authorized.

4535 679 62381 Rev B

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