W GE Medical Systems

W GE Medical Systems P.O. Box 414, W-709

Milwaukee, WI 53201-0414

1 April, 1999

Larry Camper Materials Safety Branch/MNS/NMSS

a" N Mail Stop T-8F5 SWashington, D.C. 20555-0001

Attn: Mr. Camper

Dear Mr. Camper:

General Electric Medical Systems (GEMS) purchased the worldwide Nuclear Medicine business and associated assets from Elscint, Ltd. of Haffa, Israel, which owned Bscint, Inc. GEMS now owns all aspects of Bscint1s Nuclear Medicine and all of Elscints Nuclear Medicine business assets have been transferred to GEMS, Including the Attenuation Correction (ATC) Option described in the attached application for license.

Sincerely,

Safety and Regulatory for X-Ray, Nuclear Medicine & PET

Tel: 414-544-3061 Pager: 414-558-7686 Fax 414-548-5197 Email: [email protected]

EL rOMS ELscint General Electric Medical Systems E ELGEMS Ltd. * P.O. Box 170 e Tirat Hacarmel 30200 ISRAEL. Tel: 972-4-972-4-8563660. Fax: 97244577662

Sergio Steinfeld, Tel: 9724-8563642, Email: [email protected]

April, 1999

Dear Reviewer

It is the Intention of GE Medical Systems to market the Attenuation Correction Option (ATC) for use on their dual head Nuclear Medicine Imaging Systems (Millenium MG gamma camera). This option includes two sub-assembly devices called ATC Rod Units containing a radioactive line source. This application is submitted for the purposes of the NRC conducting a radiation safety evaluation and for registration of this device, which Is designed to contain by-product material.

The information contained within this application follows the format of the guide Consolidated Guidance About Materials Licenses: Applications for Sealed Source and Device Evaluation and Registration - NUREG-1556 Vol. 3 dated on July 1998.

We would like to inform you that our representative in GEMS is: Mr. James E. Beebe, Ph.D. X-ray Projects - Safety & Regulatory Phone : 414-544-3889 Fax : 414-544-3061 E-Mail : James.Beebe0med.-ge.com

Kindly contact me if you have any questions in this report.

Sincerely

Sergiot r/nfeld MG AT ystem Engineer R&D D pt Tel: (972) 4-8563642 Fax: (972) 4-8577662 Email: sergio [email protected]

ELGEMS Ltd. Mail Address: P.O.Box 170 - Tirat Hacarmel 30200 - ISRAEL Location: Hayozma St. 10 - Tirat Hcarrmel 30200 - ISRAEL

I

TABLE OF CONTENTS

INFORMATION PAGE

First Page Information 1 Description 2 Labeling 7 Diagrams 8 Conditions of Normal Use 8 Prototype Testing 11 External Radiation Levels 12 Quality Assurance and Control 12 Limitations and Other Considerations of Use 12 Safety Analysis Summary 17

Appendices

Appendix A - Engineering Drawings Appendix B - Operation Manual Appendix C - Service Manual Appendix D - DuPont Pharmaceutical Data Appendix E - Labels Appendix F - Radiation Measurements Appendix G - Prototype Testing Appendix H- Source Packing Information Appendix I - Quality Assurance Program

Notes: I.The pages in the application letter are numbered sequentially (19 pages)

2.The pages in appendixes A, D, E, F, G, H, and I are numbered starting with the letter of the appendix, followed by the sequential page number.

3. The pages in Appendix B have a footer title P/N 490-3102-06

4. The pages in Appendix C have a footer title PIN 490-3102-07

2

Registry of Radioactive Sealed Sources and Devices Safety Evaluation of Sealed Source

NO.: NR- -S- -S DATE: PAGE 1 of 19

SOURCE TYPE: MG ATC Rod Unit - Attenuation Correction System for Nuclear Medicine

MODEL: ATC Rod Unit PIN ASM 000415

MANUFACTURER: ELGEMS Ltd. Mail Address: P.O.Box 170 - Tirat Hacarmel 30200 - ISRAEL Location: Hayozma St. 10 - Tirat Hacarmel 30200 - ISRAEL

DISTRIBUTOR:

ISOTOPE:

Gadolinium 153

GE Medical Systems 3000 North Grand View Blvd. Waukesha, WI 53188 USA

MAXIMUM ACTIVITY

2 x 450 millicuries (2 x 16.6 GBq)

LEAK TEST FREQUENCY: 6 Month

PRINCIPAL USE:

CUSTOM SOURCE:

CUSTOM USER:

(V) General Medical Use

X YES NO

N/A - This device is not specifically designed or constructed to the order of a single licensee.

atc_nrcregupd.doc


NO.: NR- -S- -S DATE: PAGE 2 of 19 SOURCE TYPE: MG ATC Rod Unit - Attenuation Correction System for Nuclear Medicine

DESCRIPTION:

a) Details Of Construction: The MG ATC option includes two MG ATC Rod Unit (the device) each one containing a 450 mCi Gd153 radioactive line source. Each MG ATC Rod Unit is being installed on its base unit on the inner and outer ring of the Gantry, where the head detectors are also assembled. Both MG ATC Rod Unit devices have identical electromechanical infrastructure and independently controlled by the Acquisition Station. The mechanics of the MG ATC Rod Unit device is based on linear source surrounded by five main elements. From both sides of the source are two cheeks that are made of lead in their internal side for shielding and aluminum cast structure from the outside. Along the source there is a lead collimator to control the radiation coming out from the source. At the two ends of the source there are the end units that hold these three parts together. The rear (back end) one contains a solenoid that activates the tungsten shutter that blocks the radiation from coming out through the collimator. The front unit (front end) has a bearing for the shutter and an indicator for the shutter position. These two units are made of lead and brass for shielding in aluminum cast casing.

The materials that the product is made of are usually non-corrosive like lead, brass, tungsten and aluminum. The steel parts are zinc plated if they are internal and painted if they are external parts.

Details of construction, materials, dimension and tolerances can be found in the engineering drawings in appendix A.

Details of assembly methods, QC and integrity verification can be found in appendix I, Quality Assurance Program, Assembly and QC test Instructions.

b) Describe radiation safety features of device.

The MG ATC Rod Unit was designed as beam limited device equipped with a long live collimated source of Gadolinium -153. The source is solid sealed with an activity of 16.6 GBq (450 mCi). The rod source Gd 153 is sealed with the exposed end having an additional 3.0 mm brass filter strip which reduces the equivalent source activity to 244 mCi for scanning purposes and extends the source life. When the device is in use, only the active area of the line source is directly towards the front of the collimator aperture

atcnrc_regupd.doc




The shutter mechanism is equipped with Tungsten cylinder bar attached to a rotational spring solenoid, which remains closed when the source is not in use, when power is lost to the device or when detecting potential failures. Thus radiation is not unnecessarily emitted. In the event of any malfunction, a mechanical Lever should be used by the user to force and lock the shutter in the closed position.

A yellow light, located on the ATC Base unit, indicates when the shutter is open and the radioactive source is exposed.

Reference: Appendix A, Engineering Drawings: Isometric Draws. No. 7, 8, 9, 10, 11, 12 & 13. Collimator Draw. No. MEC 003452

Appendix B, Operation Manual, pp. 1-3, 1-4, 1-5, 2-7, 2-8, 2-9, 3-7, 3-8, 3-9.

Appendix B, Service Manual, pp. 1-5, 1-6.

c) Description of the shielding and method for securing the source in device.

The Gd-1 53 sealed line source is glued by DuPont to a grove on a source holder made of carbon steal SAE 1020 (see manufacturing drawing A-22 in Appendix A). The black oxide treatment applied on it, is a corrosion protective treatment complying with MIL-C-13924 CLASS 1 standard. Details of the adhesive used by DuPont to fix the source can be found in appendix D, page D-3.

The source holder is contained within a coarse pitch collimated enclosure, which is shielded when not in use. The source, collimator and the shutter mechanism are enclosed in a lead-shielded rod.

The source is exposed (shutter opened) by rotating a tungsten cylinder between the source holder and the collimator slit. The tungsten cylinder is mounted on a spring solenoid, which remains closed when the source is not in use, during power failure or to the device, or when detecting potential malfunctions.

Reference: Appendix A, Engineering Drawings: Isometric Draws. No. A-1112/13/14118 Collimator Draw. No. 531- 3102

atcnrc=e.rg_upd.doc




d) Description of the on-off mechanism and on-off indicators.

On-off mechanism There is no separate power on-off for the device. The devices are installed on the camera gantry and connected to the camera. Power is supplied to the device when the Gantry is turned on.

On-off indicators

1) A yellow LED indicates when power is supplied to the spring solenoid and thus the shutter is opened and the radioactive source is exposed. Standing on any side of the Gantry, the operator is able to see the LEDs located on both Rod Units.

2) A mechanical Lever attached to the shutter indicates the actual shutter position, i.e., closed or open. The Lever is located inside a window at the extreme end of each device unit. The shutter position is shown by the label attached next to the Lever, where" I " indicates that the shutter is open, and "0O" indicates that the shutter is closed. The Lever can be manually set and locked the closed shutter position in the event of any malfunction. The operator is able to see the levers of both Rod Units.

3) When the MG ATC option is activated, the rods start to scan axially and the shutter is opened. A warning message is displayed on the GenieAcq Acquisition Station (Status Area) as follows:

This message warns the operator that the source shutter is open and transmission photons are being acquired.

Reference: Appendix A, Engineering Drawings: Isometric Draw. No. A-17

Appendix B, Operation Manual, pp. 1-3, 1-4, 1-5, 2-7, 2-8, 2-9, 3-7, 3-8, 3-9

Appendix C, Service Manual, pp. 1-5, 1-6

e) Shutter or source position mechanism to exposing the source.

The shutter mechanism is equipped with tungsten cylinder bar attached to a rotational spring solenoid, which remains closed when the source is not in

atclc..n regupd.doc



use, when power is lost to the device or when detecting potential failures. Thus radiation is not unnecessarily emitted. The radiation beam is blocked when the tungsten-shielded shutter is closed. The radiation beam is accessible for human exposure when the shutter is open.

Detailed description The solenoid is a 45 degrees rotary type with front haft extension and return spring provided.

The tungsten bar is assembled to the Rod Clamp Inside (see drawing A14) which is attached to the solenoid shaft. When the solenoid is not energized,

the tungsten bar is positioned between the collimator and the source holder blocking the transmission radiation (see drawings A-12 and A-15). Because the non-centered position of the tungsten bar referenced to the solenoid axis shaft, the bar will perform a rotation displacement of 450 when the solenoid is energized. At that position the tungsten bar moves away between the collimator and the source holder allowing transmission of the radiation (see drawings A-13 and A-16).

Reference: Appendix A, Engineering Drawings, pp. A-12, 13, 14, 15, 16.

f) Testing for proper operation of on-off mechanism and indicator.

The two slotted switches sense both positions of the tungsten rod shutter: - closed position, when one switch is "On" and the second "Off' i.e. the radiation from the line source is blocked - fopen position when the first switch is UOff" and the second "On", the radiation is emitted out through the collimator. A plate connected to the rotational clamp, moves between the optical switches when the solenoid is energized or not. The shutter test, performed every power on of the system, performs a three stages cycle (close/open/close) of the shlutter mechanism checking the right status of both optical switches at each stage. Furthermore, the optical switches are on line monitored by the system, also when the MG ATC option is not activated, in order to assure the normally shutter close position.

Reliability and diaQnostic tests The report results of the shutter mechanism reliability, diagnostics and power failure safe-fail can be found on appendix G, MG ATC Rod Shutter test report, test No. 453-3201-0002.

atcnrc-reg-upd.doc




The failure rate acceptance criteria for the slotted switch is zero. The life test, performed on the shutter with a 2500 times open/close cycle, equals to 12 month life without any failure. In case of failure, specific instructions are provided to the user to close and locked the shutter and call service personnel.

Reference: Appendix G, Prototype Testing, Shutter Mechanism Report. Appendix B, MG ATC Option Operator's Manual, pp. 3-7, 3-8, 3-9.

g) State the radioactive source classification according to the system

in ANSI N542.

Radioactive Source Model Designation:

Supplier: DuPont Pharma, 331 Treble Cove Rd., N. Billerica MA 01862

Model: Transmission Line Source NES 8429 NRC Registration: MA-0476-S-1 17-S Standards: N542-1977 ANSI class 77C32314

Radionuclides and Maximum Activity:

Radionuclide - Gadolinium 153 Max. Activity - 450 mCi +20% (16.6 GBq), -10% (on request delivery date) Form - Sealed Source. Note: Two sources used per system. 900 mCi total per system

Reference: Appendix D, DuPont Pharmaceutical Data, pp. D-3 +D-10

atcnrcregypd.doc




LABELING:

a) description of the labeling for the device.

Each device will be labeled with the following information:

1. Label I - Warning Label pin 705-3671-0901 Warning: Radioactive Material Enclosed. Universal Radioactive Symbol Label Isotope ID (Gd153) Activity Level in MBq Date of mfg. (Month/Date/Year)

2. Label 2- MG ATC ROD SER. No. Label pin LBL000343 Manufacturer name and logo. Unit model name Serial number

3. Label 3 - Open/Close Label pin 705-3685-5102 Open/Close (position of the shielded shutter)

The sealed source container will be labeled with the following information:

4. Label 4- Sealed Line Source Label Caution - Radioactive Material Transmission Line Source NES 8429 Radionuclide: Gd 153 Activity: 450 mCi Date: YY/MM/DD Lot Number: S8429X-GXXXX Company ID (DuPont)

5. Label 5- Transmission Source Installation/Renewal label Instruct the service personnel to mount the source container to the source holder of the MG ATC option.

Reference: Appendix E, Labels

b) How and where the labels are attached.

The Shielded Source Holder label will be affixed by the service personnel installed the source, in accordance with the Sealed Line Source label.

atcnrc_regupd.doc




The MG ATC manufacturer will affix the device identification label to the rod Cover.

The MG ATC manufacturer will affix the Mechanical Lever label close to the Lever window of the shielded rod.

The source manufacturer will affix the Sealed Line Source label to the source ship container. (NRC registration NR-0476-S-1 17-S)

The source installation/renewal label will be affixed on the source ship container by the MG ATC manufacturer,.

The Labels are made of Lexan and are attached to the device by Mac-Tac adhesive.

Reference: Appendix B, Operation Manual, pp. 2-11, 2-12 Appendix C, Service Manual, pp. 1-10, 1-11 Appendix E, Labels

DIAGRAMS: See appendix A - Engineering Drawings

Contents page Isometric Projection Drawings list A3 Engineering Drawing list A4 Isometric Projection drawings A5-A1 8 Engineering Drawings A19-A46

CONDITIONS OF NORMAL USE:

a) Description of the planned use of the device.

The MG ATC Attenuation Correction option provides the operator with the means to measure the patient body attenuation effects on patient images, and to correct for those effects, thereby reducing attenuation artifacts in single photon emission computed Tomography (SPECT) images.

The attenuation is measured using a radioactive source on one side of the patient, and measuring the transmission of the photons that travel through the patient and arrive at the detector. The transmission is measured at a range of angles, using an acquisition similar to that for a step-and-shoot SPECT acquisition. This data is reconstructed to obtain attenuation coefficients in the transaxial sections.

atcnrc_regupd.doc




The ATC Rod unit device, which includes the Gadolinium 153 source holder, the shielded housing, the coarse pitch collimator, and the shutter mechanism, is aligned and scanned along the long axis of the patient. A radiation beam of gamma rays goes through the patient and detected by the detector. Two identical ATC Rod units are mounted, one opposite each detector, allowing acquisition of 1800 SPECT data with a 900 gantry rotation.

The ATC Rod Unit is designed to hold the sealed source holder, the shielded

housing, the collimator and the shutter mechanism.

Reference: Appendix B, Operation Manual, chapter 3, pp. 1-1, 1-2

b) Is it portable or Installed in a fixed location ?

The device is installed on the ATC Base Unit, which is permanently mounted to a dual head Anger camera gantry, such as the Millennium MG System.

There are two devices, each one being installed on its base unit on each inner and outer ring of the Gantry, where the head detectors are also assembled. The device will not be use for a mobile van unit. The devices are fixed. Only authorized service personnel, or someone licensed by NRC or an Agreement State, may handle the device.

c) Identify the extremes of environment and operating conditions.

The ATC Rod Unit is designed for use in controlled clinical conditions and should not be subjected to conditions exceeding those specified by ANSI 542.

The transportation of the device and the source container to the site is done separately. The device, not including the line source, is transported from the device manufacturer (ELGEMS). The source container, which includes the source holder with the line source glued, is transported from the source MANUFACTURER (DuPont Pharmaceuticals) to the site, on a shipping box in compliance with U.S. Department of Transportation packaging specifications for USA DOT 7A Type A radioactive material (49CFR 178.350).

d) Types of users.

Physicians and other healthcare professionals.

e) Location of use.

Hospitals, clinics and other healthcare facilities.

atc_nrcreg_.upd.doc



f) Occasions when persons will be near the device.

Patients will be near the device when they undergo a scan procedure on a gamma camera on which the device has been installed. Operators will be near the device during scan setup and acquisition. Service personnel will be near the device during installation, maintenance and testing.

g) Frequency of these occasions.

Patients and/or operators will be near the device whenever gamma cameras (with MG ATC attenuation correction system) are used to acquire data. Typical patient workload is 10 patients/day. Service personnel will be near the device at initial installation planned preventive maintenance (every 6 month) and service visits.

h) Expected useful life of the device.

10 years.

atcnrcreg_upd.doc




PROTOTYPE TESTING:

The completed prototype tests are discussed in Appendix G, Prototype Testing. The tests

include:

Radiation Leak Test

MG ATC Rod Shutter Test The purpose of the test is to check the circuitry design and reliability of the shutter mechanism.

Effect of Basic Transportation on Transmission Line Source Radiation Leakage The transportation of the device and the source container to the site is done separately. The device, not including the line source, is transported from the device manufacturer (ELGEMS). The source container, which includes the source holder with the line source glued, is transported from the source MANUFACTURER (DuPont Pharmaceuticals) to the site, on a shipping box in compliance with U.S. Department of Transportation packaging specifications for USA DOT 7A Type A radioactive material (49CFR 178.350).

In order to demonstrate how vibration test are satisfactory for the transportation of the device to the site, we performed the following tests:

a) Basic Transportation Test (MIL-STD-810D, Method 514.2 Procedure 1) of the device without the source holder. See report in appendix G page G-9.

b) The source holder, with the glued sealed source, was sent within the shipping container to us (ELGEMNS) by the source manufacturer (DuPont Pharmaceuticals) on a type A package. See test report Radiation Leakage from the Transmission Source Shipping Container in appendix F page F-14.

c) Assembly the source holder (b) into the device after the Basic Transportation test (a) and measure the device radiation leakage. See test report: Effect Of Basic Transportation (vibration) on Transmission Line Source Radiation Leakage on a device that have being performed a Basic Transportation Test, appendix G , page G-8.

Transmission Rod Unit Drop Test The test was performed in accordance with ANSI N542-1977 class 2 including leak and survey test results.

atcnrc_regupd.doc




EXTERNAL RADIATION LEVELS:

Transmission Source Rod Radiation Profile Test reports a) In-Beam exposure measurements inside transmission field of view were 55.7

mR/h, 50.4 mR/h and 32 mR/h at distances of 5, 30 and 60 cm from the rod external surface respectively.

b) Out-Beam exposure measurements inside and outside transmission field of view are closed to background radiation and confirm the radiation is spatially limited.

c) The maximal value of the radiation leakage of 0.05 mR/h was observed at a distance of 5 cm at the front end of both rods and at 100cm and more, the radiation measurement was less than 0.01 mR/h.

Patient Exposure Test reports that a radiation exposure rate of 30.4 ± 0.4 mR/h in the center of the radiation beam at distance of 50 cm from the both sources.

Radiation Exposure for Workers and other Personnel test reports: a) The maximal exposure to hand of the worker during source exchange procedure

(for 10 sec exchange) is less than 0.04 mrem and typically 0.01 mrem. b) For other personnel the dose is minimal: the source is contained all the time

inside the radiation shielding of the rod (radiation leak is less that 0.1 mrem/hour).

Radiation Leakage from the Transmission Source Shipping Container test reports that the measurements comply to transmission line sources shipping container design specifications. The shipping box is a type A package provided by the source supplier DuPont.

See in appendix F, Transmission Source Rod Radiation Profile Test (F3/F1 1)

QUALITY ASSURANCE AND CONTROL:

See in appendix I, Quality Assurance Program, Assembly and QC Test Instructions.

LIMITATIONS AND OTHER CONSIDERATIONS OF USE:

* Installation

a) Installation procedure

Reference: Appendix C, Service Manual, ch. 3, section 3.3

b) Who will install the device

atcnrcjre8gpd.doc




The ATC Rod Unit is to be installed by Service representatives of GE Medical

Systems.

c) Integrity inspection of the device received on the site.

The integrity of the device received from the manufacturer (ELGEMS) is checked by GE personnel during the MG ATC system installation according to the following instructions in the Millenium MG ATC Service Manual (appendix C):

1) Hardware Installation, chapter 3. , Section 3.6, Radiation Leakage Test. The device is checked for radiation leaks after completing the installation. The test is performed according to the requirements of ANSI N542, Appendix A: Dry Wipe Test.

2) Attenuation Correction Checks and System Calibration, chapter 4., Section 4.2, Shutter Function and Rod Motion Check. The purpose of this test is to ensure the functionality of the shutter mechanism.

* Radiological Safety Instructions

a) Precautions or warning labels.

All precautions or warning labels are discussed in Section Labeling

b) Specific instructions for safe operation and maintenance of the device

Reference: Appendix B, Operation Manual, chapter 2, pp. 3-7, 3-8, 3-9, 4-5, 4-6 Appendix C, Service Manual, pp. 1-3, 1-4, 4-1, 3-3, 3-6, 5-1

c) Leak testing instructions.

The sources contained in these devices shall be tested for leakage at time intervals not exceeding six months. Leak testing shall be in accordance with the individual license requirements issued by the NRC or Agreement State. Leak test; N542, Appendix A: Dry wipe test, should be performed on the rod by wiping all external surfaces of the shielded rod with dry filter paper. The user has no access to the internal line source. Surfaces measuring activity level less than 5 nCi are considered to be free from leakage.

Reference: Appendix B, Operation Manual, pp. 2-9. 4-5 Appendix C, Service Manual, pp. 1-7, 3-6

atc_nrcreg_.ypd.doc



SOURCE TYPE: MG ATC Rod Unit - Attenuation Correction System for Nuclear Medicine d) Identify service operations not to be done by user.

Repair, installation, source replacement, and training of the MG ATC option will be conducted by representatives of GE Medical Systems only

Reference: Appendix B, Operation Manual, pp. 1-3, 2-7, 2-8, 3-9, 4-1 Appendix C Service Manual, pp. 1-3, 1-4, 3-3, 5-1

e) Procedures to control radiation hazards in damage or malfunctions.

1) If power to the gantry or MG option fails, a spring mechanism will pull the tungsten cylinder shutter to the closed position shielding the source.

2) Incorrect indication of the shutter position should not occur, due to the design of the unit. If any malfunction of the shutter mechanism could occur, the mechanical lever indicator correctly indicates the position of the shutter since the mechanical indicator is part of the drive mechanics.

3) Damage to the outer housing resulting in access to the exposure source or causing the source shutter shield to be stuck in an exposure position, is unlikely. The source is entirely enclosed by the housing. Exposure of the source (as postulated above) could only occur if the unit was severely damaged while it was scanning. This is unlikely, due to the intended use of the device.

4) In case the device is accidentally damaged, specific instructions are described in the Operation and Service Manual.

Reference: Appendix B, Operation Manual, pp. 2-8, 2-9 Appendix C, Service Manual, pp. 1-4, 1-5, 1-6

f) Caution against tampering with of modifying the device or unauthorized removal of the source contained in the device.

The source is contained within a rod, which is held in place with structural screws that are not intended to be unscrewed by the user or service engineer. Warning instructions are specified in the safety chapter of the Operation Manual, to discourage unauthorized access to the source.

Reference: Appendix B, Operation Manual, pp. 2-8, 3-9, 4-1. Appendix C, Service Manual, pp. 1-3, 1-4.

atc.nrcregupd.doc



SOURCE TYPE: MG ATC Rod Unit - Attenuation Correction System for Nuclear Medicine g) Instruction for source insertion and removal.

Only GE personnel (trained in source handling), or someone licensed by NRC or Agreement State may insert, remove, or handle the source used in this device.

Reference : Appendix B, Operation Manual, pp. 1-3, 2-7, 2-8, 3-9, 4-1 Appendix C, Service Manual, pp. 1-3, 1-4, section 3.5, section 5.1.

h) Recommendations for disposal of the device (source).

Only GE personnel (trained in source handling), or someone licensed by the NRC or Agreement State, are responsible for disposal of their sources. Sealed sources used with the ATC Rod Unit should be returned to the supplier (DuPont Pharmaceuticals).

Reference: Appendix C, Service Manual, pp. 3-6, 5-4.

Servicingq

Type and extent of services to be offered to customer. for the following services:

Who is responsible

Radiation survey. Repair Leak test Source replacement Relocation Training Installation Maintenance Calibration

Distributor X (installation) X X (installation) X X X X X X

Note: Only GE personnel (trained in source handling), or someone licensed by the NRC or Agreement State may insert, remove, or handle the sources used in this device.

Maintenance to be done by the user

The device maintenance activities to be done by the user are explained in the appendix B, Millenium MG ATC Option - Operator's Manual, chapter 4 Maintenance as follows:

1) Cleaning Parts of the MG ATC Option - page 4-5

atc_nrcreg_upd.doc

User X

X

X



SOURCE TYPE: MG ATC Rod Unit - Attenuation Correction System for Nuclear Medicine 2) Radiation Leakage Test - page 4-5

Maintenance to be done by the vendor

The device maintenance activities to be done by the vendor are explained in appendix C, Millenium MG ATC Option - Service Manual, chapter 5 - Planned Maintenance as follows:

1) Source Replacement - page 5-1 2) Led inspection - page 5-6

atc nrcreg-upd.doc




SAFETY ANALYSIS SUMMARY:

The safety analysis of the ATC Rod Unit states the following:

1) Source Installation :

The Gd-1 53 sealed line source is glued to a grove on a source holder made of carbon steal SAE 1020 (see manufacturing drawing A-22 in Appendix A). The black oxide treatment applied on it is corrosion protective treatments complying with MIL-C-13924 CLASS 1 standard. Details of the adhesive used by DuPont to fix the source can be found in appendix D, page D-3. The source holder is shipped to the site in a shielded source container. A detailed description of the instructions and drawings for mounting/replacing the

line source is written in the appendix C MG ATC Service Manual, section 3.5 and section 5.1. A set of mechanical drawings of the parts involved were included in appendix H Line Source Packaging Information (drawings H-4 + H17). The following list of engineering part names and their representative names in the Manual will be helpful: Source Container-Assy 18 Draw. No. 119170000 (H-4). Cover Plate - Rod Zvill Cover Inside Draw. No. 11904101 (H-5). Piston - Rod Zvill Buhna Draw No. 119040107 (H-10) Aluminum Plunger- Rod Zvill Bush Draw. No. 11904108 (H-1 1). The installation procedure concept is based on the following main steps:

a) Mounting the Source Container to the Rod Unit after removing the cover plates from both units.

b) Screwing the plunger to the piston, which was already screwed to the source holder by the source manufacturer. There is no need of any pressure, just inserting the rectangular end of the plunger into the piston protruding and securing the fastening plunger nut in the CW direction.

c) Pushing the plunger all the way in, transferring the source holder into the Rod Unit. When the source holder is properly located inside, the mark on the plunger is in line with the end of the source container.

d) Turning the Aluminum plunger CW to unlock the source holder from the piston and pulling both the plunger and piston all the way out.

e) Releasing the plunger from the piston by turning it CCW and replacing the end cover plates.

The exchange procedure is based on the same concept. Note: Detailed instructions and drawings can be found in the appendix C MG ATC Service Manual, section 3.5 and section 5.1.

atc-nrc-regN.upd.doc




The entire Source Container is safely shielded containing lead parts along the tube and on both ends.

Reference: Appendix A, Engineering Draw. pp. A-14, A-22. Appendix H, Source Packaging Information. Appendix B, Service Manual, section 3.3, 5.1. Appendix F, Radiation Measurements, Radiation Leakage from

Transmission Source Shipping Container.

2) Source shipping :

The source holder with the source glued is stored within a shielded lead-shipping container. The lead-shipping container is transported to the site within a " Type A" package (U.S. Department o Transportation packaging specifications for USA DOT 7A Type A radioactive, aerial -49CFR 178.350) with the appropriate labeling.

Reference: Appendix H, Source Packaging Information. DuPont document subject: Gd-153 Source Holder dated at 28/01/98.

Appendix E, Labels, Sealed Source Label. DuPont fax dated 1/7198.

3) Dose

Radiation dose to patients for a typical attenuation correction procedure has being determined as being less than 2mR.

Reference: Appendix F, Radiation Measurements. Patient Exposure Test Radiation Exposure for Workers and other Personnel.

4) Source Shielding :

Shielding within the source holder reduces radiation levels to acceptable values from all sides of the rod.

Reference: Appendix F, Radiation Measurements. Transmission Source Rod Radiation Profile Test.

5) Power Failure:

The shutter mechanism is equipped with a spring solenoid which remains closed when the device is not in use, when power is lost to the

device, or when detecting potential failures. Then, a tungsten cylinder, mounted on

atcnrcregupd.doc



the spring solenoid, rotates to the position between the source holder and the collimator slit, i. e., blocking the radiation.

In case of any malfunction, a mechanical Lever can be used by the user to manually set and lock the shutter in its closed position.

Reference: Appendix A, Engineering Drawings. Isometric Draws. No. 10,11,12 & 13.

Appendix G, Prototype Testing. Shutter Mechanism Test Report

Appendix B, Operation Manual, pp.1-5, 2-8, 2-9, 3-7, 3-8, 3-9 Appendix C, Service Manual, pp. 1-4, 1-5, 1-6.

6) Labels & Caution/Warning hazards :

Caution labels are affixed to the ATC Rod Unit. Identification of the source is indicated by a label placed on the front of the

ATC Rod Unit, when the source is installed. Caution/Warnings hazards are included in the Operation and Service Manuals.

Reference: Appendix B, Operation Manual, pp. 2-7, 2-8, 2-10, 2-11, 3-9, 4-1 Appendix C, Service Manual, pp. 1-10, 1-11 Appendix E, Labels

REFERENCES: no references

J ISSUING AGENCY:

U.S. Nuclear Regulatory Commission

Date: Reviewer : Name of 11. Reviewer

Date: Reviewer : _ _ _ _ Name of 2ha. Reviewer

atcnrc'regupd.doc

EL.OEMS MG-ATC

MG ATC Rod Unit

Appendix A Engineering Drawings

ATCNRCAPPA.DOC A-1

EL EMS Contents

Isometric Projection drawings list Engineering Drawings list Isometric Projection drawings Engineering Drawings

ATCNRCAPPA.DOC

MG-ATCPage

A3 A4 A5-A18 Al 9-A44

A-2

EL OEMS MG-ATC Isometric Projection drawings list page

Draw. No. 1 - All Assembly Rod Unit (from back-end to front-end parts view) A-5 Draw. No. 2 - All Assembly Rod Unit (from front-end to back-end parts view) A-6 Draw. No. 3 - Front-end parts Assembly - front view A-7 Draw. No. 4 - Front-end parts Assembly - rear view A-8 Draw. No. 5 - Back-end parts Assembly - front view A-9 Draw. No. 6 - Back-end parts Assembly - rear view A-10 Draw. No. 7 - Front-end exploded view - internal parts A-11 Draw. No. 8 - Front-end combined view - shutter close A-12 Draw. No. 9 - Front-end combined view - shutter open A-13 Draw. No. 10 - Front-end view of Solenoid, Shutter and Collimator - general A-14 Draw. No. 11 - Front-end view of Solenoid, Shutter and Collimator - shutter close A-1 5 Draw. No. 12 - Front-end view of Solenoid, Shutter and Collimator - shutter open A-16 Draw. No. 13 - Mechanical Lever view - shutter positions A-17 Draw. No. 14 - Source Holder and source A-18

ATCNRCAPPA.DOC A-3

EL EMS MG-ATC

Engineering Drawings List

Rod Cov. Cast (Aluminum) Rod Cover Mold ( Lead) Rod Cover Mach. Rod Source's House Rod Clamp Inside Rod Cover Adj Outer Collimator - MG ATC L/ S Arm Cast (Aluminum) US Arm Mold ( Lead) Left Rod Mach R/S Arm Cast (Aluminum) R/S Arm Mold (Lead) Right Rod Mach

S-Rod Cover Adjustment Inside

Rod Cover Inside Rod Lead Justment Outer Rod Plate Inside Rod Plate Lead Front Inside Rod Lead Plate Cover InsideRod Lead PlateRod Lead Cover Rod Lead Outside Up Rod Lead Outside Rod Source Lead Finish Rod Rod Filter 1.5 mm -

Page

Draw. No. MEC-003510 Draw. No. MEC-003509 Draw. No. MEC-003508 Draw. No. 119040005 Draw. No. MEC-003917 Draw. No. MEC-003500 Draw. No. MEC-003452 Draw. No. MEC-003504 Draw. No. MEC-003505 Draw. No. MEC-003512 Draw. No. MEC-003506 Draw. No. MEC-003507 Draw. No. MEC-003511 Draw. No. MEC-003915 Draw. No. MEC-003516 Draw. No. MEC-003517 Draw. No. MEC-003522 Draw. No. MEC-003952 Draw. No. MEC-003987 Draw. No. MEC-003923 Draw. No. 119040043 Draw. No. MEC-003955 Draw. No. MEC-003990 Draw. No 119040046 Draw. No. 119040099 Draw. No. 56131020200

A-19 A-20 A-21 A-22 A-23 A-24/1,2,3 A-25 A-26 A-27 A-28 A-29 A-30 A-31 A-32 A-33 A-34 A-35 A-36 A-37 A-38 A-39 A-40 A-41 A-42 A-43 A-44

ATCNRCAPPA.DOC A-4

Draw. No.1 - All Assembly Rod Unk (from back - end to front - end parts, isometric view)

SFront-end parts assembly Isometric draws No. 3/44j

General: length - 653.1 mm width - 50 mm height- 57 mm weight - 7.3 kg

A-5FL

Back-end parts assembly Isometric draws No. 5 / 6

zlx=

C( Draw. No.2 - AII'ssembly Rod Unit (from front - end to back - end parts, isometric view)

General :length - 653.1 mm width - 50 mm height - 57 mm weight- 7.3 kg.

yi ~•J.

braw." No. 3 - Front-end parts Asse( "ly Isometric front view

Draw. NC(: - Front-end parts Assembly Isometric rear view

Isometric rear view

Rod Cover Adj Outer Draw. No. MeC oc3

R/S Arm Draw. MEC oo35o6 Draw. NeCc 00 3 5o7 Draw. Hmc oo354.4

Rod Cover Draw. MeCoOo5 5o02

Draw. MSC oX3•3,o5 Draw. mme oo•5•o

Rod Lead Outside'D a_D~•W _, __.__ _____99

Draw. N eC oo3qqo Draw. 3,t Oo 5Draw. cc3o

A-8

II

Draw. No. 5 - Back-end parts Assem(I Isometric front view

LU SArm Draw. tC'(_.oo3;o Draw. ,ec. >03505 Draw. Njc oo15 1 z

Collimator .

Rod Cover Adjustment Inside Draw. No. MC _oo00917"

Rod Lead Plate_Draw,..o jpIEC oOO5:

RIS Arm Draw. MEC oo35o6I Draw. rE- oo 3,50Draw.t4_ 00 35441

A-9

furaw. No. 6 - Back-end partsAssembly' Isometric rear view C

Rod Lead Plate Cover R F Rod Plate Inside - D•L r w o f ' ut

[Drb~w. No. Mcc oo0at'zz

Rod Plate Lead Front InsideI Drwo, Mec oo •,q"5_'.

R/S Arm Draw. m•ec oo3506

D ra w .M q . o o 3 5 o' .

i.t .. . •- -. ..... J. . Solenoidl

&{ L±QMe R ~,od Cover Adjustment inside "i

Ia Drw C~.te

oRI:

Draw. Pa-C oo35oq Draw. fecoo 3sog A~n Draw.Hecc 00350If

___________________________ I '

r•

Draw. No. 7 - Front-end exploded virw 0

Internal parts

R/S Arm Cast (Aluminium )-Draw Mec-- o035O0 R/S Arm Mold ( Lead )-Draw. Ner- oo3.o7Right Rod Mach-Draw. ku-c-oo "35.4,

Y

XJz

Draw. No. 8 Front-end combined view Shutter close

A-IZ

C

x izv i x__Jz

Draw. No. 9 Front-end combined view Shutter open

A-13

C

Y

J Z

C

Draw. No. 10 - Front-end view of Sol( )id, Shutter and Collimator - General C

Rod Clamp Inside Draw. tIf-_C-0039f7l

Y

x11A-4

Draw. No. 11 Front-end view of Solenoid, Shutter and Collimator (Shutter close )

(

A-1

S.1 I.-

Y

x ]z

C

C

Y

x IZ

CDraw. No. 12 Front-end view of Solenoid, Shutte and Collimator ( Shutter open )

I Draw. No. 13 - Mechanical Lever - Shutter ositions -C ISource~oo0

ource Closed & Locked

A-i7-

Source Closed

C Draw. No. 14- urce Holder and source

Rod SOL SKI

I Rod Source's House --r-. o.... 11040

IDraw. No. 119040005

"" Y'

SECTION AA

MANU. TECH:SAND CASTING MATER IAL:A356 R20___, HEAT TREATMENT:T5 R20_TYPFINISH:SAND

BLAZING DRAFT ANGLE:2 DEC. GENERAL TOL. :+/- 1MM GENERAL FILLET;R=3MM

MECO03510 AA

0 90C 3-~LIE NAME, DA0 IsE. rEUR PEA PROJCTION. ASSEMBL W1*-(*ý DrE S I*LE fC _I :;7, 14c0 025109 I,-F"b-9 12:01A IN G

4A0 9S

C ~ ~~NEW DOCLP.ENr - '~ E

A

20

SECTION AA

MECO0.3509 AA

kg 0. 60!201 707802856 LEAD INOT KG 26 2 ea - .Dci7 OIMECDOJ5 7DAA ROD COVER CAST. 1

REMARK~S or OWO.NO. UN ITS QUANT I TY U/%ý CA-A..OQ NO. NAME7

NAME? CA__ rE EuOEA r , , ,,N E G .0 2 0 N A ),4 E P C Q ~ 5 8S ' E F

A-?O

C-270.i TYPx2 I I I I Ih

6

Al \1 I

o 05

R19

00

L0)

06.5+0.5 TYPx2 NOTES: 1. NO SHARP EDGES. .04•• 3 TYPx2 . 0 A 2. FINISH: PAINT GE#1-70000130313

C14 EXTERNAL PAINT ONLY. x MASK LEAD WHILE PAINTING.

MEC003508 AA

_. 1 00 ý70 M.COOJ509 ROD COVER MOLD. C'(Z

REMARKS or OWC.N. UNITS OUANTITY u AALOG NO, NAME No

SECTION AA 04-l TYPx2 t,.o srP-

x NA,, DATE f EURPEA, Rj~rC

OETAIL B SCALE 2:1

vYE A

4-40 UNC , 0.5 X 45"

S0.51-0 =A Ck 4P

SCALE 2:1

<I..

0

VIEW A SCALE •:1

MATERIAL: SAE1020 (1Ox20std.) FINISH: BLAK OXIDEPERI1,~22SL~,

DETAIL 0 SCALE 2:1

ELGEMS LTD. P.O.B. 170

Tirat Hacarmel 30200

ALL DIMENSIONS ARE IN MILLIMETERS UNLESS OTHERWISE SPECIFIED

I

)

_CETAIL C

NOTE.

0.2 X

I,

J!

FINISH:- BLACK OXIDE PER MIL-Q-13924 CLASS I i,

I -- I I -- -� --

ZONhE Z ApNE1 OESCROP I omI APPR. W AE R ev CI4A1N ORID. I

I � easel n IC

NAMI- OA i i- IA)HUI-LAN 014()JiýC 1 1C.N. eMI N I AS;E:MILY NAW

T"SIGNLR 4.02 9ý 0114"Slems fool 1: W 0 !F". ?ýG-ATC ROD'ASSY is-Im Fin-Ift R- - FiNi

CHECKER GILAD 8. k r 24ý= Zo- SH No. 1 -,0,0,0,4.-,1,5, APPROVAL YOSSI M. 214.02 9 F125 0 1 NAME

COmlEmIS PROPIN tLGE.S LIU. fol.."of SýF.C-FSC 2.0: 1 . ROD COVER ADJ. OUTER

0.2 1 z- ORAWING No,

2 I 0EG*

LAST OP. FOTOT-E [I P130 VERS. M. REV.

ý;;'Gf He NEXT OP. FSHEET I CIF3

II I II

XkMECO03500 AA

. I ~ Im 0.03110OI 731,50310475 jBRASS RNO BAR 70MM? RFMARIKS..,re DW(,NO,__ I uNiTrs QUANr iTY jU/MfA-Al.Or, NO, NAME �NO

jA 2'-4.1

" Al 0008 AI

C

SECTION B-BFOR PART LIST SEE PAGE1 MECO03500 AA

i FINI SH

ASSEMBLY NAME ROD ASSY . . .. .. .o0(

.. 2sA., NAMEI 2 FRO2.0:1.01DRO COVER ADJ. OUTER 01 T~..NT SPEC:W.O. fl

R E- .-.. l [IV VERS. CH. REV.

No. X Y Descr. Tol.

1 0.0 0.0

2 -4.0 -5.5 SEE No.10

3 -10.0 -5.5 SEEN .

4 - 4 .0 - 1 1 .5 s EE NO.i

5 -24.4 -8.5 SEE Nm.12

6 -47.0 -6.0 SEE No.9

7 -46.2 -22.0 SEE SECTION 8-9

8 -28.3 -17.8 SEE SECTIO 8e-0

9 -40.0 -38.5 SEE SECTION A-A

10 -34.0 -38.5 SESECTION A-A

11 -28.0 -38.5 SEE•SECTION A-A

12 -18.0 -38.5 SEE SECTION A-A

13 -10.0 -38.5 SEE SECTIO A-A

14 -17.6 -26.1

15 -9.9 -26.1

16 -q.9 -17.A _

17 -17.6 -17.8

FOR ECO SEE PAGE 1

PART LIST SEE PAGE1

lNI sH

,ri25 fOL.NOT Spec-p-eo 1

MECO03500 AA A',.,LMiLy NAK:

ROD ASSY Fl.ý, , , _00,00,4,1

2.0:1.0oIROD COVER ADJ. OUTER

-1 2 -'t YRS. CM(. REV.

TYPX2 DEEP

Azi-q-

C

4.0±o.I TYPX2

0. 5+o- TYPX2 1 ."- o 02

10 5OTYPx51

I 10.31

SECTION A-A SCALE 2:1

Ah -0

IC

! *.4-44.

VIEW C SCALE 2:1

YPx:

ZONE DEICRitiOm APPR._ DATE REV CI 9AXE CPO.

NEW OOCL1ENT ( 5.01.19949 0-____

1-10.21 2"25.' TYP

-- . I i - i . 2 51o

I/ IO.21EI

76.4*0.22

÷*X oV .

SECT ION B-B SCALE 2:1

NOTES: 1. REMOVE SHARP EDGES 2. MATERIAL OF PART 3 IS:

LEAD WITH 6x MAX ANTIMONY 3. TOTAL LENGTH TORSION: 30' 4. PARTS: 1 . 2 WILL HAVE

"IRIDITE PROTECTION COATING. a- 5. GLUE PARTS 2.5 & 1 TO PART 3 >" USING 2 COMPONENT EPOXY.

2 MEC003452 AA

eo 1.00 70 10.3 MM BRASS FOIL 5 9 60.0027 CHC40100005 JARALDITE 2XI7 Mr. 4

kg 1.5020j 70;30285267 JLEAD INGT KG 26 3

eo 1.00 701 1AL 6061-T6 2

eco 1.00 70_ JAL 6061-T6 1 REMARKS or DIWG.NO. UNITS CUANTITY U/M4CATAOG NO. NAME

NAME B-ATE IEUROPEAN PROJErTICN, E CU -- E•NT ASEMBLY NAME

0ESl1WR DANNY E. -y 2•01 t9 0IMENSIMS I d~l|,: Wt /DE•G

MsichcM'H c-M-6E DAND.1"FINIS CHECKER GILAD) 9. .• ' .0. SEE NOTE' No.-0 1 1lt '' 1 t '

h,.g V eL YOSS 20 Igo,.e. I AXT63 SC SL! NAME

"PrJ1 I CMG-ATC COLLIMATORCl. CO=,E,,, ,*M .,,, OF ELGES ,o FO.,,,=..,o : 1.0:2.0

'P'oi l :ovl Sý,ETE Tle I F004• I /-S. -•4.1REV

NOTE: MANU.TECH:SAND CASTING MATERIAL:A356 HEAT TREATMENT:T5 FINISH:SAND BLAZING DRAFT ANGLE:2 DEG. GENERAL TOL.:+/- 1.5MM GENERAL FILLEr:R-3MM

\/ 250 TOL.0V SPECII(IO

I 1.5

1.0:2.51LUS ARM CAST

IM•eI~I-IcVl-I-S.Cl' REYi

C

w.

wiI

L (0

31_ 100 TYPx5 "-1- -,18

c

SECTION A-A 1:1

A-2-7

OEC.FO.Arm, DATE REV C"Am" qOft.

NEw oocuwNrN 14.07.1999 0

AA

MCCO03505 AA

1kq 7.001201 7:,180285267 ILEAD INOT KG 265 2 eo 7. 00ý70 M.EC0O35O4AA JLS ARM CAST 1

REMARKS of OWO.NO. UNITS OUIANTITY ulA~C.A..!OG NO. INAME NO.

h~iNec., .3A0Is..' ASSEXTL NAME3I IsEE O

c

ul�fl

U

- f A

544 +0.05

VIEW CNOTES: 1:I 1. NO SHARP EDGES. 2. FINISH: PAINT GE#1-70000130313

EXTERNAL PAINT ONLY. MASK LEAD WHILE PAINTING.

A-28

8.9 TYPx4

VIEW D 1:1

UNC#6-32 \ DEEP 15+3 TYPx2

-ui

D

SECTION BB 1:1

MEC003512 AA

125 I 02.0 LEFT ROD MACH. TI•t.m•o• socl o-ito :I{ I

PING N'.

VERS VA,. REV.

C IFU--

Uc-4Li

BY::45

u-

u U

V) Z6N LLI I 1ý 0 1%

+ z (D z M C*4 -:LLJ < tr) tAi -i

C-) -i LLI W z LAJ<M -. <-J-i

I--- - I-- x < <

-cr V) ý- cr cr

LL) =) Lu I-- - LL- LL) W z ý- < z < z z

0 < < w - cr W LLJ

Z MMXLC:)Oo

Z�E OESCftIPTI�4 OATE fttv I CNU4OE �O. I

I I

I I-I*It-.o6 19941 a

SECTION A-A 1:1

C

.7

MECO03507 AA

k~g 17.001201 70180285267 ILEAD INGT KG 26 2

ea I .O00 70 ME.COO3506AA JRIS ARM CAST 1

REMARKS or DWC.NO. UNITSIQUANTITY JU/ACA-ALOC NO. INAME NO._ I ' I NAME" Clt EUOPAN•e+e PROJECTION. E--':.PmPlif Asse~ME.Y NAME•

o,.+.+.o CINNY E..-we MG-ATC ROD ASSY TI -aA - 029FINISH

0A.•. E "O,,O..,15

La -1.0:2. 0R/S ARM MOLD•.-'

r;rat m.aca,.rm •o•s 0700 ,, Is Erae NETP. MCIi[031 I F"Eir -1 0 c1 1Po rVEqS, C'•. REV.

I APPA.ZONE DESCRIPTION DATE REV I C"ANGE MO. I

C

D I -II

II I II

C

A

UNC#6-32 DEEP 15+3 TYPx2

7 AA

NOTES:

1. NO SHARP EDGES. 2. FINISH: PAINT GE#1-70000130313

EXTERNAL PAINT ONLY. MASK LEAD WHILE PAINTING.

A-34

eao 1 o.o00701 M COOJ507AA IRIS ARM MOLD.• IREMARKS or WOW.NO. JUN ITS I ULANT ITY _ U~/%d CA-ALOG NO. INAME ]O

',NAME D ATE, EUOENPRJC: ASSEMBLY NAME

DESim IAN E. ,F;1 4.02.9'°•s='":• ' MG-ATC ROD ASSY C H E CK E R. . G I L A D B,• I , / J R " -1 4 .0 . 'E " O E'. • s , , , , 4 - 1 5 APPROV ,AL IYO SS I tf ,K L . 2 .02 . • ,, 2 S :. . " N•A M E.

I •"• I1.0:2.0tRIGHT ROD MACH.,' qFr~lr P-4l• .R ~ ' LCN tO L 't,NOT SPE -I[€ TOI2 .

.,w ,,•uu•'m•o ~l p.•,l!.•0 2 l• 3RAwNG No.

ri•ed Ndcv,ý 0200 ls'oof NEXT OP. I S-EEr T OF I ! Ss. ,A. R•v.

rIa OESCRIPY.ON APPA. .ATE REV CHANGE ORO.

NEW DOCUM.ENT 14.02.1999 0

54JI~lL

-,mj

Si~~4p~W f

166L 7L 'S

IUGw~IedCIp eAlqOJe -841 l U!S. IBU161JO S841 :AdO

29-v

1 Z91JIM

%.4MN S1INS

issL. Ilg

iI.

17'V Nw hI1

T--T

I''

I I 1W21 i-i I�i1)M

We's.

)

)

'Is .v

ra-Soilal

3M t:*g-I

me-

sibsoo 7GW

I :

C IMW VCV 10. 1 ..

II I I I I

5.0 (STKJ

/-2.0 X 450 v/2PL

24.5

1..

-HEAT TREAT!ENT FINAL TREATMENT 6E A T

bIDEA Machine 0levetopment. Design

.....oduc.tion Ltd

DESIGN BORIS j12/08/97 DRAWN BORIS a26/0/981

MAP

gun ow"hlf 9fCI~fI

oumloI"u OnE In m.

m-I.s ±Ot ±0 2 hlA.fl 10,1

N8 (NO

A 1 CAE:2 : 1

9.0.'m ummm ur "m nLUm - 0- -Wmwm a~ Wawa mUw. a-= r

"mlem" wj V-TRANSACT

ROO LEAD JUSIMENT OUTER

WG NO -REV:

M E C 0 0 9 1 8 , A

I I�.m I I I -. -�

-Is

Aq-34?

VAlt AM

S"Lumo SWEET Ca __ _j

- IFT

DATE SIGN

I CHECK SHLOMO rAppon

1�31

0 4.7.0.30 2PL

-OA 0.101 A C

82.0° *2.00* 2PL

4PL

jbOPY: The original is in the f archive department

I 15. 12. 19g7

,� GEMS

f450 X 1o.0

v 8Aw.-UM U =Ltf @ a" - Pm. -MM" a W. ~ 1 wow f~ 3v W -W

C

I

C

5.0 tSTK]-s.

.5 X 450 PL

HEAT TREATMENT FINAL TREATM'ENT [MATERIAL OTY

LEA I

b IDEA Machine Development. Design

& Production Ltd.

DATE SIGN

IN.ES CrIMOW IEI ID

OUEWdIHfm AK KMan.

QW. UM*1 ±0 . 2 *ARSM, 101S

Kfl9JL VVB O.5X45-

FINISH

DESIGN BORES 1?/1O/97

DESIG BALE I S 39/10/9 CHECK SHLOMOj

N8 (NO-)

SC31ALE: 2: 1

Ri=' V-TRANSACTFU .UjM

PORT NAME

ROD PLATE LEAO FRONT INSIDE

ME-C 003q52 IY A_________________________________________________________________ cm___ J.

UQUMM WLWM 19 - POO" -W MW ~ UVWW U18~ WVA .29" k .. W

P EV. IR MSWTIm 81V 1 P

B

F

6

A-3b�I4t flMfl

I

NAME

C ~-28.5-

4

I I I�F V I I I

37.0

L_________ .1. 1��

42.0 -

HEAT TREATMENT F INAL TREATMENT IMTRA T

_I Iz~zILEADb DEA

Machine Devetopment, Design & Product ion Ltd.

SIGN

DESIG GAB1 2-/01/981 DRAWN GABS 128/01/98j

oCHEI SHLOMO ___ ___

DIMMrNU~ AKl IN m.

UN. 1U.11; ! 0 .2

REHM MA.L SWP 1M O.SX45'

N8 (NO

A CL :

Flu mpUEmjW \ELS\ROO\L-098

PART NAIE

ROD LEAO PLATE COVER INSIDE

OtrIENSION T=2.O0(1STK I

I REY: IUHE q0 3q 87- A

I APPRS I SH-01 * 1 1 fl - I

B

-i-A

58.0

DATE

A -3ir ý =URN is am ým - ý -mm"m m WIMA-0 ~ wum MýN r 04

C

-42.0-

733.5

'it

HEAT TREAThF.NT F INAL TREATMENT MATERIA L0 CTY

I _ __ 4 LEAD T=2M

IDEA Machine Development. Design

& Product ion Ltd.NAJ( DATE SIGN FINtSN

DESi~IG BOR IS 12/08/911____ 1 DRAWNi BOR IS 19/01/98 ___

CHECK SHLOrIO I___ =d

au. Km.-, !0. 2

iwmwl m. smml EmUs 0 .5X451

N8 (NO

%31SCAE: : SHET OFF

APPR- I ALM

lImA p V-TRANSAC

'" ^\ELS\ROO\L -091 PART NAM

ROD LEAD PLATE

DIMENSION

Fm -NO:-- REV:

SmEC oo39?2ý AI

NI

H

co

A-36

NAME DATE S IGN FINISH

§[email protected]ý M ý ý0 - - -l""M 6 W-0-0 l0" WMOMW

jrn. ILls: I CCXI WT1� I SAWS I *..I Ii i i I I

I II I I I

I I I I I

1 .0

-2.0 (STK]

HEAT TREATMENT FINAL TREATMENT IMTRA T

I. IIILEAD jIbIDEA

Machine Devetopment. Design & Production Ltd.

-f-I-I

DATE S IGN

DESIGN GABI1 27/01/981 1___

DRAIM GABI1 28/01/98 ___

*PPRO I SHLOMOAPMW ISHLOM

WEISS 20-ISNI CFE

010W OL ME O .SXS

FINISHN8 (NO

~\SCALE' : SHEET F

Imoom =m is No P3.M" w - Wfw 0 W.6 No -mm I

""~'" "4VAR ICAM ELS

FIINw*w\ELS\ROO\L- 100 PART NAM

ROD LEAD COVER OI1ENSION

I m NO: IAf# tq04001 1 A YE:II S

C, I I

NAPE

A-3q

iI I

. I KV. I LYN.' ' I MXRWTICK I 0ýw I am

i

I -- �

! i i1I I

11.5

•)IDEA Machine DeveLopment, Design

& Produclion Lid.

DATE

NESSN nInomwlC IVIES OIPEN310" NK IN -.

06m.7•00l±0.5

me0t ALL SUPP 10M( 0 .SX45

SIGN 1 FINISH

EAS IG EITAN 26/01/98

DRAW EITAN 26/01/98 ,

CHECK SI-LOMO ____ ___

N8 (NO-)

SCALE: 2:1 SH4EET OFl

""w "VAR I CAM ELS PILE UUW* \ELS\ROO\L-0 10

PART NAIE

ROD LEAD OUTSIDE UP

OItENSION

? -003955 , I

C -------

6.5-0o.s

R 2.0

4L L2.0 [STK]

HEAT TREATHENT FINAL TREATMENT MATERIAL 0TY ILEAD. I-

5-

Fm

0

110.0LN C)

I

NAME

A-10.•I4 A'MA'

C � U S *rn10 - .� nn S �S* WYSS em. �. C- , -, I , -I I I

a

7--

I

IRIW ILTI. I I GAl! II I

d I-i-F iI I I

Trk

HEAT TREATMENT IF INAL TREATMENT I MAER IALI OTY

b IDEA Machine Development. Design

& Production Ltd.- I ¶ � I

RAW DATE S IGN

DES IGN GABI *26/01/98 ____

DR~AWN G3ABI1 26/01/98 ___

CHECK SHLOMO1 I______

SHL0110I L

lUtERs 1NcMir IS If

OIN1(6W AK fit o.

sm. lm.sI i 0. 2 MUIR: moll

U1VE LIL 34/ EM RSI0.X45*

FINISH N8 (NO

A 3 SCALE: 2:1 SH4EET F

,mmm" Mman., "r ml,. mlmwf rnrnrn w ."a.~ W win "

"""w'VAR I CAM ELS

" imm\ELS\ROIJ\L-011

PARVT NAM

ROD LEAD OUTSIDE

OIENS!ON

IOWG NO: IREV]~ IMseL- 003q901 Q

C.I Ii II II i

7.5

A-41,

g

a

I - I .-. I

I I

OESMIPTIN I CAR I OM

IKY. ILIW.I @AltYI~ Ini IAPP

I- I-I I I I

I Ii I

--- f3.2+0.2

1 .91

\ -5 X 1 .0 41 PL

HEAT TREATMENT FINAL TREATMENT I MATERIA L IOTY

I A ~2

b IDEA Machine DeveLopment. Design

& Production Ltd.

DATE S IGN

DESIGN GAB 1 121/01/981 DRAWN CM 1AB 12____01/98

G(Oc SILOMO ___ ___

APPRO I SHLOMO

UKMS orImIisIWcIFZ

OveuGaeW AK IN

mm- It" ± 0 . 2 AkV~n: 20lS

RUEW ALL l4W EMS 0 .SX45-

FINISHN8 (NO-)

A- .1. A

'~wc"VAR ICAM ELS

Fumeue\ELS\ROO\L-0 12PART NAPI

ROD SOURCE LEAD FINISH

DIMENSION

ý 'ý119040046 A ':V S

A-4Z ----

C 'H-I I

7.0-0.2

3.5 6.8 -0.1.

�1 .7

NAPIE

i i

I Kv. I OR. I OESCRIPT100

1 .00

COPY: The original is in the archive denartment

15. 12. 1997

ErCJ4

014

1 ROD FROM TUNGSTUN I DENSITY 19.3 DIAMETR 5.0 ± 0.025 MM; STRAIGHTNESS 1 0.12 MM.

FL EM; P/i "rz 7,10 ' 0o2oooo0j

A-43

S

um. ,bm mm -• P•u Mmn UK-&• n W la Qft• R 4-wo"! m

,)

tit,•wv 1.003.0+

);

I &ppo. I nAll I REyI C.AWGE ORI)

1 .5 STD

0.qm O0 1140170150-301151IRSSH 1. 5MM

[REMARKS at OWC.NO. JUN ITS IGU A;TIT U/ECINr No. NAME NO.

NAME OATE ELACPEAN PROJECrSCN. dEUt .Pl.EM ASSEMBLY NAME

2ýIESG'( DNA. - .U9IF.IO45Cd VRNACT F ILTERES ASSY

pAPesP"At .o si.'e SCL ..0:2.0FILTER - 1 .5 ITrln

.0 161If-310 fUZUU Li

tASI OP

l.-.P.l ORAWIN No.~fl

AF - t4 I:,I *v1e..e' 5. O Pu.eg ,z I. I~ I 561 VIMSA. Im 131020MO. 04-11.1.98 14:5

54.3.'

4' CA

3W-N ')I

543l' - I

! 0 1

ELOEMS MG ATC

MG ATC

Appendix B Operation Manual

ATC_ NCAPPB.DOC B-I

Millennium MG

ATC Option

N'

Operator's ManualRev.O

Table of Contents

Chapter I - Description .... Overview ..................... Base Unit ...... ............... Rod Unit .....................

Collimator ................. Shutter ................... Lever .................... Lever Locking Plate ......... Warning LED ..............

Chapter 2 - Safety ........ Safety Definitions ........... IEC Symbols Used .......... System Specific Symbols ..... Source Handling ............ Radiation Safety Devices ..... Potential Radiation Hazard ....

Radiation Leakage Test ......

. . . . . . . . . . . . . . . ....0 . * 1-1

....................... 1-1 ................................ 1-3

.1.3.. .. . . . ...... .. .. .. . 1

....... ..... ... ... ... ..... . . 1-4

....... ...... ..... .......... 1-4 ................................ 1-5

................................ 1-5

................................ 1-5

S..M.. 2-1 ........ 2-4 ......... 2-5 ........ 2-6

........ 2-7

........ 2-7

........ 2-8

........ 2-9

Chapter 3 - Operation .......................... 3-1 Overview ..................................................... 3-1 Application .................................................... 3-2 Transmission Scan Mask ........................................ 3-3 Features ..................................................... 3-4

Method of Operation ............................................ 3-5 Emission and Transmission Scanning ............................ 3-5

Transmission Source Activation Indicators ........................... 3-7 Safety Precautions ............................................. 3-7 Simultaneous Interleaved Emission/Transmission Scanning ............ 3-10

Overview ................................................. 3-10

MG ATC Operation Manual P.N. 490-3201-06

Rev. 0 December 98

K>

. . . . . . . . . . . . . . . . .

...............

...............

...............

......... o.....

............ e..

I

Acquisition Scheme ............................................ Image Prescription ......................................... Energy Set Prescription ...................................... Termination Prescription ..................................... Tem plates ................................................ Sequential Emission/Transmission Scanning ..................... Sequential Transmission Scan Prescription ......................

3-11 3-11 3-11 3-12 3-12 3-12 3-13

Chapter 4 - Maintenance......................... 4-1 Calibration Scans ........................................... 4-1 Source Profile Scan Acquisition ................................ 4-3 Radiation Leakage Test ...................................... 4-5


Rev. 0 December 98Ii

Description

Chapter1 - Description

Overview

The ATC option Is a package designed to correct for attenuation effects when imaging with the dual-head gamma camera, while both Detector Heads are positioned at 101.250 to each other (in L-shape mode). It consists of the following:

"* A pair of ATC Base Units

" A pair of moving ATC Rod Units, each assembled on its specific Base Unit and housing a sealed and shielded radioactive line source

"* Acquisition software

A Base Unit and Rod Unit Is permanently mounted on the inner, as well as the outer, Gantry Ring When the system is in H-Mode, the ATC option is Inactive and the Rod'Units are In the Parked Position. When the system is In L-Mode, the ATC Rod Units are positioned directly opposite the Detector Head. In this mode, the patient lies between the Rod Units and their opposing Detector Heads.

This chapter describes the components of the MG ATC option.


December 98 Rev. 01-1

Q.J

(Lj

Overview

Description

1--) 'ellow Warning LED

LED

Figure 1-1. ATC Option Parts Assembled on the Gantry (L-Mode)

-lJ



Overview

Description

Base Unit

The Source Holder Base Unit (ATC Base Unit) includes the motion drive mechanism of the Rod Units and their mechanical/electrical connections. A Base Unit is permanently mounted on a plate attached to each of the gantry rings (inner and outer).

Rod Unit

Each shielded Rod Unit comprises a sealed line source, a collimator, a shutter mechanism and a warning LED. The shutter controls the emission of the radiation beam through the collimator slit. The warning LED illuminates when the shutter is open, to Indicate that the radioactive source is exposed.

Ax WARNING

All handling of the rod units, including: removal, replacement, installation and repair, must be performed only by suitably qualified service personnel, authorized by the Vendor.

Each Rod Unit (see Figure 1-2) includes the following parts: "* Collimator

"* Shutter

"• Lever

"* Lever Locking Plate

"* Line Source

* Warning LED

MG ATC Operation Manual P.N. 490-3201-06 1-3

December 98 Rev. 0

Base Unit

Description Rod Unit Collimator

Top Side Lever Locking

Base Unit Side Plate

Figure 1-2. ATC Rod Unit

Collimator

The line source radiation commences through a slit collimator located at the bottom of the Rod Units. The slit collimator ensures the transmission of a narrow beam that hits only the Field Of View (FOV) of the opposite Detector, minimized dose to the patient.

Shutter

The radiation beam Is controlled through a shutter equipped with a spring, that ensures that the shutter remains closed when the source is not in use. The shutter Is automatically closed and opened according to operation mode of the system and the progress of the activated acquisition.



Description Rod Unit Lever

Lever

A mechanical Lever attached to the Shutter indicates its actual position, I.e., dosed or open. The Lever is located inside a window at the extreme end of each Rod Unit. The shutter position Is shown by the label attached next to the Lever, where 01" Indicated that the shutter is open, and "0" indicates that the shutter is dosed. The Lever can be manually set to the close position to close the shutter in case of malfunction.

Lever Locking Plate

A Locking Plate is used to lock the Lever in the closed position in case of malfunction. When the system Is functioning properly, the Locking Plate is secured in the Unlocked position, enabling automatic opening and closing of the shutter, as required according to the acquisition in progress.

Warning LED

While the shutter is Open, a yellow LED on each rod unit illuminates to indicate that the rod source Is open



Chapter 2 - Safety

General Safety

1. This product was designed and manufactured to ensure maximum safety of operation. It should be operated and maintained in strict compliance with the safety precautions, warnings and operating instructions contained herein.

2. The system has been designed to meet all the safety requirements applicable to medical equipment. However, anyone attempting to operate the system must be fully aware of potential safety hazards.

3. There are no user serviceable parts in this system. The product should be installed, maintained and serviced by qualified service personnel according to procedures laid down in the product service manuals.

4. The system in whole or In part should not be modified in any way without prior written approval by ELGEMS Ltd.

5. The owner should make certain that only properly trained, fully qualified personnel are authorized to operate the equipment. An authorized operators list should be maintained.

6. It Is Important that this Manual should be kept at hand, studied carefully and reviewed periodically by the authorized operators.

7. The manufacturer or Vendor of the equipment makes no representation, however, that the act of reading this manual renders the reader qualified to operate, test or calibrate the system.

8. Unauthorized personnel should not be allowed access to the system.

MG ATC Operation Manual Rev. 0 P.N. 490-3201-06 2-1 December 98

Safety

9. If the product does not operate properly or If It falls to respond to the controls as described in this manual, the operator should: "• First ensure the safety of the patient and then the safety of the

equipment, following the safety precautions as specified In this manual.

"• Freeze the situation and prevent any changes. "• Immediately contact the service office, report the Incident and await

further Instructions. Tel: 1-800-437-1171 Fax: (901) 387-4110

10. The images and calculations provided by this system are Intended as tools for the competent user. They are explicitly not to be regarded as a sole Incontrovertible basis for clinical diagnosis. Users are encouraged to study the literature and reach their own professional conclusions regarding the clinical utility of the system.

11. The user should be aware of the product specifications and of system accuracy and stability limitations. These limitations must be considered before making any decision based on quantitative values. In case of doubt, please consult your sales representative.

12. Electrical Shock Hazard - do not remove or open system covers or plugs. Internal circuits use high voltage capable of causing serious injury.

An electrical hazard may exist if any light, monitor or visual Indicator stays on after the system is turned off. To prevent possible injury, turn off the switch in the mains power supply box on the wall and contact your service office immediately.

Fuses blown within 36 hours of being replaced may indicate malfunctioning electrical circuits within the system. Have the system checked by qualified service personnel, and do not attempt to replace any fuse.

13. Electrical Fire - conductive fluids that seep Into the active circuit components of the system may cause short circuits that can result In electrical fires. Therefore, do not place any liquid or food on any part of the system.

To avoid electrical shocks or bums caused by the use of wrong type of fire extinguisher, make sure your fire extinguisher has been approved for use on electrical fires.

MG ATC Operation Manual December 98 P.N. 490-3201-06 2-2 Rev. 0

Safety

14. Explosion Hazard - do not operate the equipment in the presence of explosive liquids, vapors or gases. Do not plug in or turn on the system if hazardous substances are detected In the environment. If these substances are detected after the system has been turned on, do not attempt to turn off the unit or unplug it. Evacuate and ventilate the area before turning off the system.

15. Overheating - Do not block the ventilation ports of the electronic equipment. Always maintain at least 6 Inches (12 cm) clearance around the ventilation ports to prevent overheating and damage to the electronic hardware.



SafetySafety Definitions

Safety Definitions and Symbols Used

Safety Definitions

The safety instructions In this manual are used for the protection of the patient, operator and service personal. They identify hazards that will or may occur if instructions are ignored. The identified hazards are defined and classified as follows:

DANGER

Danger Is used to Identify conditions or actions for which a specific hazard is known to exist which will cause severe personal injury, death or substantial property damage if the instructions are ignored.

A WARNING

Warnings are used to identify conditions or actions for which a specific hazard is known to exist, which may cause severe personal injury, or substantial property damage If the instructions are ignored.

CAUTION Cautions are used to identify conditions or actions for which a potential hazard may exist, which will or can cause minor personal injury, or property damage if the instructions are ignored.



K)

SafetyIEC Symbols Used

IEC Symbols Used

The system may have labels with one or more of the following symbols. These symbols indicate the IEC standards to which the system conforms.

Symbol IEC Standard

\ Alternating Current

®U Protective Earthing Point

I ON / Power

O OFF I Power Off

1 O OFF (only for part of equipment)

O ON (only for part of equipment)

* Type B Equipment

4J Input Power

G+ Output Power

Functional Earth Ground

Warning, Caution - consult accompanying documents

A• Electrical Shock Hazard



Safety

System Specific Symbols

The system has a label with the following symbols.

Symbol Meaning

SShutter Unlocked

D Shutter Locked

I Shutter Open

O Shutter Closed



System Specific Symbols

SafetySource Handling

Radiation Safety

Source Handling

The sources are delivered to the hospital in shielded source containers.

1. Source handling must comply with the local regulations regarding the handling of radioactive substances.

2. Only qualified service personnel is allowed to mount the sources into the Rod Units.

Radiation Safety Devices

The ATC option includes the following safety devices:

* Shutter - which when closed, blocks the emission of the line source. Only during scanning with ATC enabled, the shutter Is open.

* Shutter Locking Plate - used to lock the shutter in Closed position in case of malfunction. In normal operation, the Shutter Locking Plate is secured in the Unlocked position, allowing automatic closing and opening of the shutter according to the acquisition in progress.

* Collimator - which minimizes the radioactivity dose to the patient and limits the radiation to the Field Of View of the opposite Detector.

* Yellow Warning LED - illuminates to Indicate that the radioactive source is exposed.



A WARNING It is prohibited to open the source containers, except during the mounting of the source into the Rod Units. This procedure must only be carried out by personnel trained in source handling.

SafetyPotential Radiation Hazard

Potential Radiation Hazard

The ATC Rod Units contain sealed line sources.

A WARNING Once acquisition commences, with the ATC option enabled, the Rod Units begin scanning, the line sources Open, and radiation transmission begins. The yellow LED illuminates to indicate that the radioactive source is exposed.

A WARNING Tampering With or modifying the ACT rod, or unauthorized removal of the source contained in this device, may result in exposure to unnecessary levels of radiation.

A WARNING

In the event of accidental damage to a Rod Unit:

1. Power Off the Gantry.

2. Verify that the shutter is Closed, I.e., the Shutter Lever on the Rod Unit is set to the 0O" position (see Figure 2-1).

3. Lock the Lever by releasing the Lock Level screw and A sliding the Locking Plate to the locked position, so that

&04 the mark is visible (see Figure 2-2).

4. Call a qualified service engineer authorized by the Vendor.

Tel: 1-800-437-1171 Fax: (901) 387-4110



Radiation Leakage Test

Lever Lock Locking Screw Lever

Figure 2.1 Figure 2.2

Figure 2-1. Shutter Lever Locked in Close Position

Figure 2-2. Shutter Lever Un-Locked in Close Position


The camera should be checked for radiation leaks at least once every six months or earlier if stipulated by local safety regulations. The radiation leak test should be performed according to the requirements of the American National Standard, Publication N542, Appendix A: Dry Wipe Test. For instructions, refer to the Radiation Leakage Test in the Maintenance Chapter 4.



Safety

K)

Radiation Safety Radiation Leakage Test

Safety

Patient Safety

For general patient safety information, refer to the Patient Safety Section In the Safety and Regulatory Chapter of the Camera Operation Manual.

1. Warn the patient not to touch the Rod Units.

Safety and Shutter Status Labels

Figure 2-3 and Figure 2-4 depict the location of the ATC safety labels and the Shutter Status Labels. The numbers used in the figures correspond to the numbers shown alongside the labels shown on the next page.

L�JI

Figure 2-3. ATC Rod Unit Labels

2-10 P.N. 490-3201-06P.N. 490-3201-06

Dec. 1998

;

2

2-10

Safety

rWARNING: ,,

RADIOACTIVE MATERIAL ENCLOSED 163Gd MBq on

705-3671-0901

705-3671-5102

2 Shutter Status Label 0

I

WARNING: DO NOT LET FINGERS, HAIR, OR CLOTHING GET CAUGHT IN THE OPENING

705,3671-0802



U

Chapter 3 - Operation

Overview

Gamma (or X-ray) radiation is attenuated when It passes through the body by absorption and scattering. In X-ray or CT imaging, different tissues are Identified, based on the degree of attenuation of the X-ray photons passing through the body of the patient. Images are obtained by processing the differences measured between the incident x-ray flow and the flow detected after transiting through the body.

Nuclear Medicine imaging uses radiopharmaceuticals that emit radiation from within the body. Attenuation (the loss of emitted photons due to photon absorption or Compton scattering), is characteristic to this type of imaging as well.

The degree of attenuation differs according to the thickness and density of the tissue that the radiation crosses on its way to the detectors. Therefore, the amount of radiation detected depends on the position of the camera with respect to the patient, and the size and shape of the patient.

The effect of attenuation Is important when the relative intensity of the images (density of counts) Is used for clinical analysis, as in SPECT imaging. Unless attenuation Is taken into account, the emission activity from the organs near the body surface is overestimated compared to the emission activity from deep within the body, which is underestimated.

The ATC option is designed to correct the attenuation effects In SPECT imaging.

In myocardial Imaging, decreased activity in the inferior wall may be caused by diaphragmatic attenuation. Breast attenuation may result in decreased activity in the anterior or upper septal walls. Attenuation correction reduces the artificial decrease in activity caused by attenuation, so that image appearance represents more accurately the actual activity distribution In the myocardium.


Primary methods of attenuation correction are based on the Chang method and assume a uniform attenuation coefficient across the body. This approximation is acceptable in areas of uniform density such as the brain and provides a reasonable correction for attenuation in such cases.

However, within the thorax the attenuation coefficients vary greatly, from low degrees of attenuation in the lungs to high degrees of attenuation In soft tissues, and even higher in skeletal tissue such as the spine and sternum. Thus an accurate correction of photon attenuation in the thorax requires measuring the local attenuation coefficient in the body.

Application

The ATC Attenuation Correction option provides the operator with the means to measure the attenuation effects of anatomy on patient images and correct for those effects, thereby reducing attenuation artifacts in SPECT Images. In order to correct for attenuation in the thorax, the shape and attenuation of the organs in the thoracic cavity must be known. The lungs, breast tissue, and myocardium are significantly different in their attenuation. The attenuation is measured by detecting the photons from a transmission source that travel through a patient. The transmission source is done at a range of angles, using an acquisition similar to that for a step and shoot SPECT acquisition. This data is reconstructed to obtain the attenuation coefficients in the transaxial sections. The MG ATC system provides the most efficient way of acquiring 180 degree cardiac SPECT data by using 90 degree rotation of its two detectors The dual transmission source design of the attenuation correction option allows a similarly efficient acquisition of the transmission data. The MG ATC transmission scanning drive Is permanently Installed and the operator does not have to spend time removing and attaching the device.


Transmission Scan Mask

An electronic transmission scan mask is available for all transmission scanning as described below. One of its main purposes is to reduce the crosstalk from the emission scan into the transmission image [9] The width of the transmission mask in the line source (X) direction is the entire detector field of view (Figure 3-4). The size of the transmission mask in the scanning (Y) direction is adjustable between 20 mm to 80 mm. This size is set in the acquisition templates as a function of the collimator selected. The transmission mask can be either positive or negative. Characteristics of these masks are described In Table 8-1.

Figure 3-1. Electronic Masking

Figure 3-1. Electronic Masking

Electronic masking, In combination with energy discrimination, Is used to discriminate between transmission and emission events. For example, in Region 1, any 100 keV event detected must be scatter from either the 140 keV technetium peak or the 167 keV thallium peak.


Rev. 0 December 983-3

Mask ta W*s c tM) *L S1I~iiiiiii ! ~l

Features

"• Parallel Transmission and Emission Geometry using two detector emission and two detector transmission imaging allows fast acquisition of 180 degree cardiac acquisitions using 90 degree gantry rotation.

" I 00keV Transmission energy allows transmission scans to be performed in patients already Injected with either 201 TI or 99m Tc.

"• Long-lived (242 day half life) solid sealed 153 Gd gamma source housed in transmission scan box.

"• Can be used to obtain transmission images with any of the MG ATC range of parallel-hole tomography collimators.

"* No collimator changing or setup required to switch from emission to transmission Imaging.

"• The ATC Rod Units are mounted permanently on the gantry. When both units are parked, there is no restriction on gantry operation in any acquisition mode.

"• Attenuation Corrected Reconstruction Algorithm installed as an upgrade to the processing features implemented on GENIE as a part of this option.



Method of Operation

Emission and Transmission Scanning.

Images Acquired

The main types of scan data acquired for Attenuation Correction are Emission and Transmission images.

" Emission Images are primarily directed at acquiring the gamma rays emitted from the radiopharmaceuticals injected into the patient.

" Transmission images are acquired with the source scanning and the detector acquires the 100kev energies emitted by the rod source and transmitted through the patient.

When a transmission scan is performed on a patient already injected with the radiopharmaceuticals, it is possible to acquire both the Emission and Transmission data into separate images. Additional images are acquired to correct for the cross-talk and scatter from the 140keV to the 100keV energy window.

* Crosstalk images are acquired with the transmission source parked and will be used to estimate the emission scatter into the 100keV transmission window.

When each study is acquired, the corresponding calibration data are referenced and these will be transferred to the processing computer for use in the reconstruction.

* Blank Scans are transmission scans with no patient. 0 Source Profile Scans are blank scans used to measure the uniformity of

the transmission source. * Uniformity Scans are flood images to measure the collimator uniformity.

Further description of these scans are found in the Calibration section of this chapter.


Types Of Tomographic Acquisitions

The tomographic data can be acquired in three ways:

• Sequential acquisitions, where a separate tomographic scan is performed for each emission and transmission scan.

0 Simultaneous acquisitions, where both the emission and transmission images are acquired at the same time per view and in one tomographic rotation.

a Simultaneous Interleaved acquisitions, where both the emission and transmission Images are acquired sequentially per each view and in one tomographic rotation.

The'ATC hardware is able to perform Sequential and Simultaneous Interleaved using multiple energy acquisitions and electronic masking to acquire the transmission and emission data into separate images.

Acquisition Templates

The same patient and many of the same acquisition parameters are used for both the emission and transmission acquisitions for attenuation corrected SPECT studies.

To facilitate the acquisition of the transmission and emission data, there are scan templates provided for most of the common heart tomography procedures. In addition, there are generic templates provided in the General' template group for:

Tempiate Name Purpose SuiiutLVVHus Tc99m Acquisln Cd Trarr isvon &Vd Tcr-jn Emrismon mgragi m

one Ur'o rotGAR

SiularOms 71201 As bc'e, but to T201

Sequemtil Tcg9m Acquivin ol Trarsm sss•n end Tc99rn Ermission wnages in two T1 As.-.tl , rquirig two I• T•.23

Sequeftia TA201 As ab: i, bul Ior r.20i ITSM)aI lrtiio-.sson scsi .4w tb ghai-Sm saens watt uno Acbv'ty

With all of these templates the user may change the acquisition time, the transmission scan time the matrix dimensions, and the start angle to suit the requirements of each study. It is not advised to change the energy session or the energy set names as these are the required names of the iterative reconstruction software.


Transmission Source Activation Indicators

While performing Acquisition of Transmission, two indicators show that the source is open and transmission radiation is exposed

(a) Warning Yellow LED is Illuminated on both rods

(b) A warning message is displayed in the status area of the Acquisition Station screen

Warning Transmission Source is Open

Safety Precautions

To ensure maximum safety of operation, the rods are fitted with numerous safety devices

(a) Radiation Shield The Source Holder is thoroughly shielded to prevent radiation leaks, which are extremely small <0.1 mR.

(b) Shutter The radiation beam Is controlled through a shutter which is fitted with a spring to ensure that the shutter remains closed when the source Is not in use. This prevents unnecessary radiation emission.

(c) Mechanical Shutter Locking Lever A mechanical Lever attached to the Shutter indicates its actual position, i.e., closed or open. The Lever is visible through a rectangular aperture at the extreme end of each Rod Unit. The shutter position Is shown by the label attached next to the Lever, where "1" indicated that the shutter Is open, and "0" indicates that the shutter Is closed (see Figure 3.3)


(d) Lever Locking Plate A sliding Lever Lock is used to secure the Lever when any electromechanical malfunction exists, preventing accidental opening.A label displays symbols, indicates the state of the Lever Lock, I.e.

Unlocked. 6 or Locked

-_0 LOCKING SCREW

LEVER LOCKING PLATE

Figure 3-2. Shutter Lever in Close Position (Unlocked)

The system continuously monitors the shutter to detect potential failures, whether or not the MG ATC option is in use. In case of malfunction or mechanical failure, the following message will be displayed In the Acquisition Station:

SOURCE OPENI

CLOSE SAFETY HANDLE

In this case, you must immediately lock the Shutter Lever Is the Close

position as follows:

1. Power Off the Gantry.

2. Check the Shutter Lever. If it is not set to the Closed (0) position, move It manually to the 0 position.



3. Referring to Figure 3-3, lock the Lever by releasing the Lock Lever screw, sliding the Locking Plate to the locked position, so that the

jITj mark is visible and re-tighten the Locking Screw.

4. Call a qualified service engineer authorized by the Vendor.

Locked Unlocked

Figure 3-3. Mechanical Shutter Locking Lever

(.J



WARNING

Do not tamperwith the Source Holders. All handling of these units, Including: removal, replacement, installation and repair must be performed only by qualified service personnel authorized by the Vendor

CAUTION

I. Do not let the 153Gd line sources remain open unnecessarily.

2. Avoid exposure to the irradiated area of the 16Gd line sources.

Simultaneous Interleaved Emission/Transmission Scanning

Overview

The Simultaneous Interleaved acquisition permits the acquisition of the same type of data as obtained in Sequential emissionltransmission scanning.

However, the emission and transmission scans are both performed sequentially In one view at a time. The Simultaneous Interleaved method is faster than the Sequential because only one rotation is required. The data collection scheme is illustrated in Figure 8-6 and shows the acquisition data In two phases for each view. All the acquisitions have the same image parameters such as matrix size, zoom, etc., and the two phases use the same energy set definitions, denoted as ES1, through ES4 in the figure.

Note: Although the emission acquisition can be either gated or non-gated, the table provides Information on non-gated imaging data.

During each time period, data is acquired into all of the energy sets. The acquisition time for each view is divided into two parts:

1. The first part Is when the transmission source is off and the emission, crosstalk, and scatter data are being acquired. No scan mask definitions are applicable since the source is off.

2. The second part is when the source is scanning and transmission, emission and scatter data are being acquired. The scan mask defined for each set positive, negative, none) is applied during the scanning phase.


Acquisition Scheme

Figure 8-6. Simultaneous Emission/Transmission Data Acquisition Scheme

For Each L View I

I

ESI Emission Energies above 10keV

ES2 EmNisson I Energies below 100keV

window 100keV

ES4 Scatter

�i�I nanamisamnr,

View Acquisition Time

Transmission Source Trans.... n•-,o Parked Sen Mask Source Scarvlrng

OFF .issn

NA�arD�&h**

I msioSri DaaI anss" ~

I .rO. stalk Data .rans .iss ... ,I

I ctter DaaI Satter data2

The data is stored in one series containing up to eight nongated image sets. Each image set is stored as a tomographic data type, which can be individually selected for cine and review.

Image Prescription

All the acquisitions have the same image parameters such as matrix size, zoom.

Energy Set Prescription

The two phases use the same energy windows and corrections, so there are a maximum of four energy sets per detector. The one mask definition for each set is only applicable when the source is scanning. When the source Is parked, the mask is off for all energy sets.



Flotale to Next VMe

I

I

Termination Prescription

Simultaneous scans require two termination conditions: time per view for the transmission scan, and time per view for the emission only scan. The total time per view is equal to the transmission and emission scan time per view. The emission scan time should not be less than the transmission scan time, because there must be a reasonable crosstalk acquisition time.

Templates

K..) Acquisition templates are provided for this form of transmission scanning, for Technetium and Thallium General Tomo acquisitions as well as for acquisitions applicable to the CEqual protocols.

Cardiac Technetium acquisitions typically use the LEHR collimator with 32stops, two detector, 90 degree rotation and the following Energy session, which result in six image sets.

SOURCE OFF 8OURCE ON ENERGY lET 9 SET NAME E SET NAME K&V WIDTH MASK

I Emission I E.mssonl2 140 20 '%VW 2 Cro alk Trarum ssion too 20 PosdVe 3 S eat1 Scattw 2 117 12 Negativ

Thallium Acquisitions usually use the LEGP collimator with 16 stops, two detector, 90 degree rotation and the following Energy sessions which will result in eight image sets:

SOURCE OFF SOURCE ON ENERGY SET E SET NAME E SET NAME KeV WIDTH MASK

t Emission I Emissont 2 6ll , •

2 Emion 3 IEffsion 4 72 20 Ne;ative 3 Cael• k rtanwrmision 100 20 PFOST

4 S.altr I Sca- 2 60 15 Negative

Sequential Emission/Transmission Scanning

The emission and transmission scanning can be performed in consecutive tomography scans.


Sequential Emission Scan Prescription

Predefined sequential AC energy session templates for 99m Tc and 201 TI can be found In the 'General > Sequential Tc99m' and 'General > Sequential T1201'which include the crosstalk acquisition window as described above. Any standard tomographic acquisition mode can be used, so the emission scan could be a multigated scan. The emission scan could be terminated on counts or triggers.

Sequential Transmission Scan Prescription

Ungated step and shoot tomographic acquisition mode is used. This is the only tomographic acquisition mode In which the user can select the transmission scanning option. During the scan the rod source starts scanning at the start of every frame and reaches the opposite park position at the end of the frame acquisition time.

The scan Is always terminated on time, not on counts. The user defines the scan time, and the acquisition time per view The scan time is 3 sec. minimum, 1000 sec. maximum.

A collimator specific blank scan correction is specified by the user. Default is the same name as the selected collimator,.

Transmission and Emission Scan Arcs

For sequential scans it is not necessary for the transmission scan starting position or scan arc to be the same as those of the emission scan. However- if the emission scan arc does not completely cover the transmission scan arc, then the emission scatter in the transmission window cannot be estimated using the emission crosstalk data. In that case, crosstalk correction of the transmission planars will not be done in the iterative recon preprocessing.


Pause/Resume

A transmission scan may be paused by the operator during the acquisition of views. If the operator pauses the scan, data acquisition is stopped immediately, while the line source will continue its travel to the end of the field of view and stop there. The current view's data Is discarded. The scan can be stopped at that point and saved, quit and not saved, restarted, or resumed. If the scan is resumed the Interrupted view is re-acquired in full.



Chapter 4 - Maintenance

A I WARNING Tampering with or modifying the ACT rod, or unauthorized removal of the source contained In this device, may result in exposure to unnecessary levels of radiation.

Maintenance of the MG ATC option includes "* Calibration Scans "• Cleaning "• Radioactive Contamination Test

Calibration Scans

Scope

This section describes how to perform the blank scan and source profile acquisitions with the attenuation correction option Installed.

Requirements

In order to process a transmission scan and produce an attenuation map, the reconstruction software requires the following calibration scans. "• Blank scans "* Source Profile scans "* Uniformity Correction Floods for Tomography



Blank Scan Acquisition

Definition A blank scan Is required for each collimator in order to process the transmission scans and produce the attenuation maps. The blank scan acquisition Is a 400 second static transmission source scan with no patient or table between the transmission scan box and the detector. Because of the high count rate, the blank scan is performed using a uniform attenuating plate on the detector to reduce the detector count rate. Frequency of Calibration Blank scans should be acquired weekly. A blank scan is required for each detector and each collimator used for transmission scanning. A full set of blank scans requires 4 scans, for the LEHR and LEGP collimators for each detector and takes around 30 minutes. Procedure Required equipment: Blank scan attenuator.

1. Fully retract the table. Fit collimators used for transmission scans.

2. Select the 'Quality Control' card, select 'Blank Scan'. Follow the instructions on the cards and enter the parameters as requested:

PARAWTO ENTRY

Dectar number I Or2 AttMer or V rckne% mm 2 Tam.ssion mask wi 1r mm 72 or 60 lor LEGPWEHR Coflirwtur LEGP or LEHR Phol•m •pllaCoftoc•n PMT

E'¶rg* correctoI ECOR S0al Cwrecwn C057

3. Use the gantry handset to rotate the detector to face upward. Adjust the Radius of Rotation to around 203mm.

4. Place the blank scan attenuating filter on the detector to be exposed as shown in Figure 3-7.



r

Figure 4-1. Blank Scan Attenuating Filte

5. Start the scan. This will take 400 seconds and the scan will build up on the display.

6. At the end of the scan, enter the name BSLEGP or BSLEHR for both detectors.

7. Remove the attenuator plate and repeat for the other detector.

8. Repeat for the other collimators used for transmission scanning.

Source Profile Scan Acquisition

Definition A source profile scan is required for each transmission scan box in order to measure the uniformity of the source so that the reconstruction can produce a blank scan at the same radius of rotation as the patient scan. The acquisition is three 400 second static transmission source scans with no patient or table between the transmission scan box and the detector. Because of the high count rate, the blank scan is performed using a uniform attenuating plate on the detector to reduce the detector count rate. The three scans are performed at a minimum, maximum and central radius of rotations to cover the full length of the rod source.


When Source Profile Scans Are Needed

Source profile scans are only acquired when the source is installed, replaced or the source filtration is changed. Each detector has a source profile which is used for all the collimators. The source profile requires three 400 second scans for each detector and takes about 30 minutes for both detectors.

Acquisition Of Source Profiles

Required equipment: Blank scan attenuator. 1. Fully Retract the table. Fit only collimators for which uniformity scans are

available. 2. Select 'Quality Control' card, select 'Source Profile'. Follow the

instructions on the cards and enter the parameters as requested:

PARAMETER ENTRY

Di.ecd number 1 ;2 Atenuaor ickness. r.ri 2

Coll.atr LEOP orLEHR Phokt•-ubpiier Cofrecbon PUT E.rgy Correc .on ECOR

Spetial COrrecijon Coe,7

Urdaonf" corrfecon LEGP or LEHR

3. Use the gantry handset to rotate the detector to face upward. 4. Adjust the Radius of Rotation to that requested on the form. 5. Place the blank scan attenuating filter on the detector to be exposed. 6. Start the scan. This will take 400 seconds and the scan will build up on

the display as shown In Figure 8-7. 7. Adjust the radius of rotation as requested on the form, and repeat the

scan. 8. Remove the attenuator plate and repeat the procedure for the other

detector. This process does NOT need to be repeated for the other collimators used for transmission scanning.



Uniformity Correction

Uniformity correction flood acquisition is described In Chapter-5, Quality Control, of the MG Millennium Operator,s Reference Manual, and not repeated here.

Cleaning Parts of the MG ATC Option

Do not use detergents or organic solvents to clean the parts. Keep the surfaces clean by wiping with a clean cloth moistenrd in 95% ethyl alcohol.


The camera should be checked for radiation leaks at least once every six months or earlier if stipulated by local safety regulations. The radiation leak test should be performed according to the requirements of the American National Standard, Publication N542, Appendix A: Dry Wipe Test.

The radiation leak test is carried out as follows:

I .Ensure that the shutter is dosed and locked

2.Using dry filter paper, thoroughly wipe all surfaces of the sealed Rod units. See Figure 4-2

3.After wiping the potentially radioactive surfaces of the Rod Units, check the filter paper.

4.If the radioactive content of filter paper is less than 5TCI the machine is considered non-leaking

1%)



Surfaces to be wiped

Figure 4-2. Checking for Radiation Leaks



E OE MS MG ATC

MG ATC

Appendix C Service Manual

ATCNRCAPPC.DOC C-1

B

Millennium MG

ATC Option

Service ManualRev.O

(%J

TABLE OF CONTENTS

SECTION PAGE

CHAPTER 1 - SAFETY AND REGULATORY

1.1 Safety G uidelines ............................................................................................ 1-1 1.1.1 G eneral ....................................................................................................... 1-1 1.1.2 Transportation and U npacking ................................................................... 1-2 1.2 Safety D efinitions ........................................................................................... 1-2 1.3 H azards ............................................................................................................ 1-3 1.3.1 G eneral H azards ......................................................................................... 1-3 1.3.2 Electrical H azards ...................................................................................... 1-3 1.3.3 R adiation H azards ..................................................................................... 1-3 1.4 Radiation Safeguards ...................................................................................... 1-5 1.5 Radiation Leak Test ........................................................................................ 1-7 1.6 Sym bols U sed ................................................................................................. 1-8 1.6.1 IEC Sym bols .............................................................................................. 1-8 1.6.2 System Specific Sym bols ........................................................................... 1-9 1.7 Safety Labels ................................................................................................. 1-10 1.8 R egulatory Inform ation ................................................................................. 1-12

CHAPTER 2 - DESCRIPTION

2.1 O verview ......................................................................................................... 2-1 2.1.1 G eneral ....................................................................................................... 2-1 2.1.2 D escription of the A TC Option .................................................................. 2-1 2.1.3 Option Content ........................................................................................... 2-4 2.1.4 Prerequisites ............................................................................................... 2-5 2.1.5 Pioneer K it .................................................................................................. 2-5 2.1.6 Installation Equipm ent ............................................................................... 2-5 2.2 Installation Procedure ..................................................................................... 2-6 2.3 Schedule .......................................................................................................... 2-6 2.4 B lock D iagram ................................................................................................ 2-7

CHAPTER 3 - HARDWARE INSTALLATION

3.1 O verview ......................................................................................................... 3-1 3.2 Equipm ent R equired ....................................................................................... 3-1 3.3 H ardw are Installation ...................................................................................... 3-1 3.4 Installing the cables.* ...................................................................................... 3-2 3.5 Mounting the Line Source into theRod Unit .................................................. 3-3 3.6 Radiation Leakage Test ................................................................................... 3-6

MG ATC Service Manual Rev. No. 0 P.N. 490-3201-07 i December. 1998

TABLE OF CONTENTS (Continued)

SECTION PAGE

CHAPTER 4 - ATTENUATION CORRECTION CHECKS AND SYSTEM CALIBRATION

4.1 IN TRODU CTION .......................................................................................... 4-1 4.2 Shutter Function and rod m otion check .......................................................... 4-1 4.3 Blank Scan A cquisition ................................................................................... 4-6 4.3.1 D efinition ................................................................................................... 4-6 4.3.2 Frequency of Calibration ............................................................................ 4-6 4.3.3 Procedure .................................................................................................... 4-6 4.4 Source Profile Scan Acquisition ..................................................................... 4-7 4.4.1 D efinition ................................................................................................ 4-7 4.4.2 Frequency of Calibration ............................................................................ 4-7 4.4.3 Procedure .................................................................................................... 4-7 4.5 Transm ission Scan Uniform ity Test ............................................................... 4-8 4.5.1 General definition ....................................................................................... 4-8 4.5.2 M easurem ent Condition ............................................................................. 4-8 4.5.3 M easurem ent equipm ent ............................................................................ 4-9 4.5.4 M easurem ent procedure ............................................................................. 4-9 4.5.5 Calculation and analysis ............................................................................. 4-9 4.6 Reporting values ............................................................................................. 4-9

CHAPTER 5 - PLANNED MAINTENANCE

5.1 Source Replacem ent ........................................................................................ 5-1 5.1.1 D isassembling the Rod Units ..................................................................... 5-2 5.1.2 Dism ounting the Expended Line Sources .................................................. 5-3 5.2 Led Inspection ................................................................................................. 5-6 5.3 Q C Procedure .................................................................................................. 5-6

MG ATC Service Manual Rev. No. 0 P.N. 490-3201-07 ii December. 1998

CHAPTER 1 SAFETY AND REGULATORY

1.1 SAFETY GUIDELINES

1.1.1 General

1. ATC option has been designed and manufactured to ensure maximum safety of operation. The equipment should be serviced in strict compliance with the safety precautions, warnings and operating instructions contained in this manual.

2. The product should be installed, maintained and serviced only by qualified service personnel according to procedures laid down in this manual. The owner should make certain that only properly trained, fully qualified service engineers are authorized to service the equipment.

3. The system has been designed to meet all the safety requirements applicable to medical equipment. However, anyone attempting to operate the system must be fully aware of potential safety hazards

4. The ATC is an option available to the Millennium MG camera. The Service Engineer must be fully acquainted with the safety precautions and guidelines specified in the System Service Manual.

5. The system in whole or in part should not be modified in any way without prior written approval by ELGEMS Ltd.

6. Do not leave the system with problems that may affect the safety of its operation. In case you have doubts concerning the system's safe operation, call the service office for further instructions and notify the customer that the system is not to be used until the problem is resolved.

7. Safe servicing requires that the field engineer has a thorough knowledge of all equipment controls and safety devices.

8. The product must be maintained according to the procedures described in the Planned Maintenance Chapter.

MG ATC Service Manual Rev. No. 0 P.N. 490-3201-07 1-1 December. 1998

Safety and Regulatory Safety Definitions

Transportation and Unpacking

1. Any damage discovered during shipment should be immediately reported to the Vendor.

2. During unpacking and installation, the system should be handled with great care, to avoid damage.

3. During unpacking and transportation, do not leave the equipment unsupervised.

4. Verify that all packages are empty after the unpacking process.

5. Before assembly, clear the area of packaging material, nails, hazardous metal pieces, dirt and rubbish.

SAFETY DEFINITIONS

Warnings, Cautions and Notes are used throughout this manual. The identified hazards are surrounded by a frame, and are used in the following way.

A• DANGER

Danger is used to identify conditions or actions for which a specific hazard is known to exist which will cause severe personal injury, or substantial property damage if the instructions are ignored.

A WARNING Warnings are used to identify conditions or actions for which a specific hazard is known to exist, which may cause severe personal injury, death or substantial property damage if the instructions are ignored.

MG ATC Service Manual P.N. 490-3201-07

Rev. No. 0 December. 19981-2

1.1.2

1.2

(%J

CAUTION

Cautions are used to identify conditions or actions for which a potential hazard may exist, which will or can cause minor personal injury, or property damage if the instructions are ignored.

Safety and Regulatory Safety Definitions

Safety and Regulatory Hazards

HAZARDS

General Hazards

1. Some repair/replacement procedures require the removal of protective covers, exposing parts at high temperatures or with pinch points. Read the safety/warning labels and follow the instructions in this manual to prevent bums or injuries.

2. Most servicing procedures direct you to remove power from the system. This is done using the Circuit Breaker located at the back of the Gantry.

3. If a procedure requires that power be maintained, you should disconnect or restrict access to all Hand-Held Controllers and the Acquisition Computer to prevent unexpected movement of the Gantry, Detectors or Table.

1.3.2 Electrical Hazards

Do not remove, or open, system covers or plugs, while the unit is powered ON. Some internal circuits operate at high voltage, capable of causing severe electric shock and/or serious injury.

1.3.3 Radiation Hazards "'XNt 11

(%)



1.3

1.3.1

NWARNING All handling of the ATC Rod Units, including: removal, replacement, installation and repair must be performed only by qualified service personnel.

WVARNING Once acquisition with the ATC option enabled begins, and the Rod Units begin scanning, the shutters open and radiation transmission commences.

While the shutter is Open, a LED on the rod unit will illuminate to indicate that the rod source is open



WARNING Tampering with or modifying the ACT rod, or unauthorized removal of the source contained in this device, may result in exposure to unnecessary levels of radiation.

A WARNIING

In the event of accidental damage to a Rod Unit:

1. Power Off the Gantry 2. Verify that the shutter is closed by looking into the

indicator window on the Rod Unit to see that the Lever is in the position marked 0 (CLOSE)

3. In case of electromechanical malfunction, the Lever and the Locking Plate should be used to Close and Lock, the shutter. See Figure 1-2.

4. Perform radiation leak check as detailed below.




Safety and Regulatory Radiation Safeguards

1.4



RADIATION SAFEGUARDS

1. The Line Sources have a fixed aperture and a limited radiation beam. The size of the radiation beam at the collimator plane is less than the detectors field of view, ensuring that radiation is not emitted to the surrounding area during attenuation correction.

2. While the ATC option is enabled, the dose rate at the collimator plane is less than 10 mRad/h. When the shutter is in the closed position, the leaking dose at the external surface of the Source Holder is less than 0.1 mRad/h.

1 Rad = 1 REM (Rad Equivalent Man). The maximum radioactive dose to which

3. A mechanical lever on each rod indicates the shutter position, i.e.,Open = I, and Closed = 0.

4. A sliding Lever Lock is used to secure the Lever when any electromechanical malfunction exists, preventing accidental opening.

A label displays symbols, indicates the state of the Lever Lock, i.e.

Locked ( or Unlocked. P

5. The system continuously monitors the position of the shutter to in order to detect potential failures. In the case of mechanical failure, the lever can be used to manually close the shutter, and a Locking Lever ensures that the shutter cannot be accidently opened. See Figure 1-1 and Figure 1-2.

K)J



Lever.

Figure 1-1. ATC Rod Unit

Lever Lock Locking Screw Lever

Lever Locked Lever Unlocked

Figure 1-2. ATC Rod Unit in "Locked" and "Unlocked" state




Safety and Regulatory Radiation Leak Test

RADIATION LEAK TEST

The camera should be checked for radiation leaks at least once every six months or earlier if stipulated by local safety regulations. The radiation leak test should be performed by the user according to the requirements of the American National Standard, Publication N542, Appendix A: Dry Wipe Test.

For details and instructions about this procedure, refer to the Radiation Leakage Test which can be found in Chapter 3 of the Service manual, or Chapter 4 of the Operator's Manual.



1.5

Safety and Regulatory Radiation Leak Test

1.6 SYMBOLS USED

1.6.1 IEC Symbols

The system may have labels with one or more of the following symbols. These symbols indicate the IEC standards to which the system conforms.

Symbol IEC Standard

( j Altemating Current

® Protective Earthing Point

I ON I Power

O OFF I Power OFF

0 OFF (only for part of equipment)

@• ON (only for part of equipment)

*Type B Equipment

,@ Input Power

(G Output Power

_ -, Functional Earth Ground

AWarning, Caution -consult accompanying documents

A Electrical Shock Hazard



Safety and Regulatory Symbols Used

1.6.2 System Specific Symbols

The system has a label with the following symbols.

Table 1:

Symbol Meaning

i Shutter Unlocked

W1 Shutter Locked

I Shutter Open

O Shutter Closed



Safety and Regulatory Symbols Used

Safety and Regulatory Safety Labels

SAFETY LABELS

Figure 1-3 and Figure 1-4 depict the location of the ATC safety labels. The numbers used in the figures correspond to the numbers shown alongside the labels shown on the next page.

1

2

1 7WARNING I A

RAItACiWACE MATERIALECOD 11~ r 1 111

Figure 1-3. Rod Unit Safety Labels

Figure 1-4. ATC Safety Labels



1.7

Q

a1 I!


d


Table 2. Safety Labels



WARNING RADIOACTIVE M�TERIAL ENCLOSED

153_Gd __ __ Bq on_

705-3671-5102Shutter Status Label2

WARNING: DO NOT LET FINGERS, HAIR, OR CLOTHING GET CAUGHT IN THE OPENING

705-3671-0802


Safety and Regulatory Regulatory Information

1.8 REGULATORY INFORMATION

The equipment complies with the IEC 601-1 standard.

This equipment generates and can radiate radio frequency energy. The equipment may cause radio frequency interference to other medical and non-medical devices and to radio communications. To provide reasonable protection against such interference, the camera complies with the emission limits for a Group 1, Class A Medical Devices as stated in EN 60601-1-2. However, there is no guarantee that interference will not occur in a particular installation.

The manufacturer is not responsible for any interference caused by using other than recommended interconnect cables or by unauthorized change or modifications to this equipment.

Unauthorized change or modifications could void the user's authority to operate the equipment.

To comply with the regulations on electromagnetic interference for a Group 1, Class A Medical Device, all interconnect cables to peripheral devices must be shielded and properly grounded. Use of cables not properly shielded and grounded may result in the equipment causing radio frequency interference in violation of the local regulations.

Due to installation in less favorable environment, this equipment may be exposed to electromagnetic and electrostatic interference. To ensure a high level of reliability when exposed to such interference, this equipment complies with the immunity requirements as stated in EN60601-1-2. for immunity Class 1. The operating conditions are classified on the basis of performance criteria as defined in EEC 801-2.



Safety and Regulatory Regulatory Information

CHAPTER 2 DESCRIPTION

2.1 OVERVIEW

2.1.1 General

Transmission Attenuation Corrected Tomography, hereafter referred to as ATC, is an option available for the dual-head variable-angle MG/CSE gamma camera.

Gamma radiation emitted from the inspected organ is attenuated by the body tissues while passing to the Gamma Detector Head. Different body tissues absorb varying amounts of radiation, depending on their structure and thickness. Therefore, the actual attenuation varies, depending on the specific patient, the angle of view, and the positioning of the patient.

The normal attenuation correction of images reconstructed from various views is based on a generic algorithm that does not consider the above factors.

The ATC option is based on attenuation correction maps created individually for each projection. These maps are based on the degree of radiation originated by an external source, which is transmitted through the patient's body, and therefore referred to as the Transmission process. The transmission of the energy used to create the attenuation correction maps and the images generated by emission of the internal radiation are acquired simultaneously by the camera. The simultaneous Transmission Emission process increases system efficiency and avoids interference with normal clinical acquisition.

The attenuation correction maps contribute to accurate reconstructions of SPECT images, and enhance lesion detection as well as volumetric quantization accuracy.

2.1.2 Description of the ATC Option

The option includes:

a. Mechanical Rod Mounting and Driving Assembly. The Transmission Rod is mounted on a carriage which travels along a linear track, which is attached to a square beam mounted perpendicularly on the gantry plate extension. A leading screw placed parallel to the beam is connected to a stepper motor axis by a coupling and timing belt. A nut on screw connects the carriage, which moves linearly when the screw rotates.

b. Transmission Rod The Transmission Line Source is a 'Gd with a half-life of 241 days. The Line Source is installed in a shielded Rod Unit, and contains a Collimator and shutter mechanism. The shutter controls and monitors Line Source emission through its Collimated opening. The spring ensures that the shutter is kept closed when the Source is not in use. An additional locking lever is used to secure the shutter in the

MG ATC Service Manual Rev. No. 0 P.N. 490-3201-07 2-1 December 1998

closed position. A mechanical lever on each rod indicates the position of the shutter, i.e. either Open or Closed. A label attached next to the lever denotes the two positions.The 153Gd line sources must be replaced once per year.While the shutter is Open, a LED on the rod unit will illuminate to indicate that the rod source is open

c. Mechanical Gantry Modifications The counterweight balance on head #2 was added to compensate for the weight of the ATC option, and ensure smooth and proper mechanical operation of the VG Lock assembly when locking the two inner bearing rings.The ATC option is permanently mounted on the two gantry rings, and the two Rods automatically move to the "park" position when not in use (see Figure 2-2). This eliminates the need to assemble/disassemble the Rods during normal operation. Acquisition with Attenuation Correction is performed in L-Mode only. A yellow warning LED indicates when the shutter is open and the source is exposed

d. Hardware support and Infrastructure

A stepped motor controller, and an additional interface card are used to:

"o Communication with the host to manage the following functions:

motion control

scan range settings

limit sensing

parking absolute locations

"o Control the shutter mechanism and sense the shutter position test points.

Additional cabling was added to supply power and control the rod, as well as a RS232 cable from the IPS unit to the GenieAcq station (Multi 10 card)

e. Software The nominal acquisition software which supports ATC is version 2.4 which includes service tests.


Description Overview

Description Overview3ase Unit

Yellow Warning

RADIATION

BEAMS

A

Rod UnitsLED

Figure 2-1. ATC Assembly - General View

Yellow Warning LED

Rods Moved to < Parking Position

Yellow Warning LED


Rev. No. 0 December 19982-3


2.1.3 Option Content

The ATC option comprises the following:

"* ATC Base Unit assembly -one for each ring (inner and outer)

"* Rod Unit- x2

"* Base Unit Cover - x2

"* Counterweight Block

"• ATC Cables:

o ATC Base Control cable P/N 475-3201-01

o ATC Rod Control and Power cable P/N 475-3201-02

o ATC LED Control cable P/N 475-3201-03

"• Lead-shielded Source Containers, PN 473-3102-0306 - x2. Each container includes a 153 Gd Line Source, attached to a Source House.

* Source Housing, PN 561-3102-4715, inserted inside the Source Container - x2

* Aluminum Plunger (used to mount and remove the Source Houses), PN 561-3102-7700

* Operation Manual, P/N 490-3201-02

• Service Manual (this manual).



2.1.4 Prerequisites

The prerequisites for the ATC option are:

"* Acquisition Software Version 2.4, distributed on a tape.

"* Multi 10 Card

2.1.5 Pioneer Kit

A Pioneer Kit has been designed to assist the service personnel in case of failures, and is mandatory for the installation.

One Pioneer Kit is required per 5 systems located in the geographic region of the field engineer.

Verify the presence and availability of the complete kits before starting the installation.

Table 2-1. Pioneer Kit

Description Part Number Quantity

Motor 2

Timing Belt 2

Micro Switch S 030000010 2

Solenoid B 01040287R 2

Motor Driver 1

2.1.6 Installation Equipment

" Tool Kit - supplied with the option

10 mm short Allen Key (a specially modified key designed to fit into a restricted space) Locking Nut Key, P.N. 561-3102-9706 Locking Nut Key L, P.N. 562-3102-0209

" Tool Kit and materials - supplied by vendor/vendor subsidiary

Round File Half round File Set of Allan Keys (inch + mm) Screwdrivers (Phillips, flat) Hammer Vacuum Cleaner



2.2 INSTALLATION PROCEDURE

The installation procedure consists of two steps, to be performed in the given order:

1. Hardware installation, described in Chapter 3

2. System Calibration, described in Chapter 4

2.3 SCHEDULE

Installation time required for ATC field upgrade:

* 6 hour for hardware installation and line sources mounting

a 4 hours for calibration

a 6 hours for the Transmission Air Frame Stability Test, which after being invoked does not require user intervention, and therefore can be run during the night.

• One day to create the option specific correction maps



Description Installation Procedure

2.4 BLOCK DIAGRAM

The block diagram is shown in Figure 2.3, provides a more detailed view of the system

HAND-HELDI CONTROLLER

SENSOR IJ C OLISON

COLLIMATOR I SENSOR

COLLIMATOR

Figure 2-3. System Block Diagram



Description Block Diagram

CHAPTER 3 HARDWARE INSTALLATION

3.1 OVERVIEW

One ATC assembly is fitted to each of the gantry rings

3.2 EQUIPMENT REQUIRED

ATC Plate 502-3201-3808

ATC Linear Base 502-3201-08

ATC Rod Holder 502-3201-10

ATC Rod 473-3201-1205

Dual Head Camera MG CSE with Acquisition Station GenieAcq

Allen Key Set Metric

Allen Key Set

Ratchet Handle 1/2" Drive

19 mm Socket 1/2" Drive

3.3 HARDWARE INSTALLATION

Install the ATC Base Adaptor, the Linear Base Plate, and the ATC Rod, according to the following instructions, which are referenced to Figure 3-1.

1. Turn ON the Gantry and bring it to the H-Mode (heads parallel) with a rotor angle of 00. Remove the Detector Cover of the upper head.

2. Fix the Adapter Plate #1 to the Main Detector Support Plate fitting the two M-12 screws first, followed by the three M-6 screws.

3. Attach the Linear Base Unit #2 to the Adapter Plate #1, and secure the seven M-8Allen Screws.

4. Assemble the ATC Rod Unit to the Linear Base Unit #2 and the Rod Holder #4, using three M-6 screws.

5. Repeat the process for the other side.


Hardware Installation Installing the cables

3.4 INSTALLING THE CABLES

The following Gantry cables must be connected to the ATC Base Unit panel:

ATC Base Control Cable

ATC Rod Control & Power Cable

ATC LED Control Cable

475-3201-01

475-3201-02

475-3201-03

ADAPTER PLATE #1 502-3201-3808

LINEAR BASE PLATE 502-3201-08

C

M-8 SCREWS Wx) )ke

.M-12 SCREWS (x2)

ROD HOLDER 54 4 502-3201-10ATC BASE 473-3201-0

M-6 SCREWS (x6)

Figure 3-1. ATC Assembly



Hardware Installation Installing the cables

Hardware Installation Mounting the Line Source into the Rod Unit

3.5 MOUNTING THE LINE SOURCE INTO THE ROD UNIT

A WARNING.

These procedures must only be carried out by a service engineer authorized by the Vendor.

The 1 3Gd Line Source is attached to a Source Holder, which is contained in a lead shielded aluminum Source Container (referred to as Source Container P/N 473-3102-03). This procedure describes the mounting of the Source Holder into the empty Rod Unit. For Line Source exchange procedure see Chapter 5 - Planned Maintenance.

NoteIThe entire procedure should be carried out while the Rod is placed securely on a flat surface. Ensure that the Shutter is closed, i.e., the lever is in the CLOSE position.

To mount the Source Holder with the Line Source into the Rod Unit:

1. Bring the Gantry to H-Mode with a rotor angle of 0'.

2. Switch OFF the power to the gantry.

3. Ensure that the Shutters on both the rod unit are closed, i.e., the lever in the CLOSED position.

4. Remove the three M6 screws holding the Rod to the Rod Holder.

5. Place the Rod carefully on a firm flat surface.

6. Remove the Cover Plate from the Rod Unit by unscrewing its two fastening Allen screws (see Figure 3.2).





Screws

Figure 3-2. Rod Unit with Cover Plate removed

7. Similarly, remove the Cover Plates from both sides of the Source Container by unscrewing heir two fastening Allen screws (see Figure 3-3).

Cover Plate Piston

Location of Container - Rod Aluminum Plunger

Cover Securing Securing Allen Screw Screws

Figure 3-3. Source Container

8. Line up the Source Container to the Rod Unit, using the locating pin protruding from the Source Container to ensure correct alignment with the Rod Unit (see Step 1 in Figure 3-4).



Hardware InstallationMontn •th LieSuceitheRdUi

Mounting the Line Source into the Rod Unit

9. Secure the Source Container to the Rod Unit, using one of original screws removed at Step 7, above (Step 2 in Figure 3-4).

10. Release the two screws which secure the Source Holder inside the Rod Unit (see Figure 3-2).

Rod

Source Container

Piston

Plunger

0fr

Figure 3-4. Mounting the Source into the Rod



Hardware Installation

11. Insert the rectangular end of the plunger into the top of the piston protruding from the Source Container (see Figure 3-3 and Step 3 in Figure 3-4). Holding the protruding section firmly, secure the fastening plunger nut in a CW direction.

12. Using the plunger, push the piston all the way in, transferring the Source Holder and Line Source from the Source Container into the Rod Unit (see Step 4 in Figure 3-4). When the Line Source is properly located inside the Rod Unit, the mark on the plunger is in line with the end of the source container.

13. Turn the Aluminum Plunger CW to unlock the Source Holder from the Pistonr and pull

the Plunger and Piston all the way out.

14. Release the Plunger from the Piston by turning it CCW.

15. Fasten the two locking screws to secure the Source Holder and attached Line Source to the Rod Unit (see Figure 3-2).

16. Unfasten the Source Container from the Rod Unit and replace the original End Plate on the Rod Unit (Steps 5 and 6 in Figure 3-4).

17. Replace the End Plate on the Source Container, and store safely. The Source Container will be required again to retrieve the expended Line Source during the replacement process.

18. Mark the Line Source manufacture date (as written on the source container) on each Rod Unit on the label marked 1 in Figure 1-3.

19. Switch ON the power to the Gantry.

20. Rotate the Gantry to rotation angle 2250 to facilitate removal of the second rod unit.

21. Switch OFF the power to the Gantry

22. Repeat Steps 2 to 18 for Head #2

3.6 RADIATION LEAKAGE TEST

After completing the hardware installation, the camera should be checked for radiation leaks. The radiation leak test should be performed according to the requirements of the American National Standard, Publication N542, Appendix A: Dry Wipe Test.


WARNING

Disposal of the used Line Sources must be in accordance with regulatory procedures

Hardware Installation Radiation Leakage Test

Hardware Installation Radioactive Contamination Test

The radiation leak test is carried out as follows:

1. Ensure that the shutter is closed and locked

2. Using dry filter paper, thoroughly wipe all surfaces of the sealed Rod Units. See Figure 3-2

3. After wiping the potentially radioactive surfaces of the Rod Units, check the filter paper.

4. If the radioactive content of filter paper is less than 50Ci the machine is considered non-leaking

Surfaces to be wiped

Figure 3-5. Checking for Radiation Leaks



Hardware Installation Radioactive Contamination Test

CHAPTER 4 ATTENUATION CORRECTION CHECKS AND SYSTEM CALIBRATION

4.1 INTRODUCTION

The purpose of this section is to provide procedures which will ensure full functionality of the

attenuation correction option

This section includes:

a. Shutter and Rod Motion Function Checks (section 4.2)

b. Blank Scan Acquisition

c. Source Profile Scan Acquisition

d. Transmission Scan Uniformity Test

OTE: To prevent unnecessary radiation exposure, ensure that no persons are in the beam path during the transmission scans

4.2 SHUTTER FUNCTION AND ROD MOTION CHECK

The purpose of the following text table is to ensure the functionality of the shutter mechanism and the system motion control.



aTTENUATION CORRECTION CHECKS and system calibration Shutter Function and rod motion check

Table 4-1. Shutter Function and rod motion check

Test Description Procedure Results Pass Fail OpenlClose test Enter the system as Service Mode and type CD 10. Then type APIMATE to enter into diagnostic and test ATC tool.

Type

Set output state 00010000 The shutter Lever is in the Verify that the shutter was opened, OPEN ("1") position. the mechanical Lever changed The Yellow Led is ON. position to OPEN ("I") position and the Yellow Led is ON.

Type Set output..state 00010001 The shutter Lever changes

Verify that the shutter was closed, the to the CLOSE (wO") position mechanical Lever changed position to The yellow led is OFF. CLOSE ("I") position and the Yellow Led is OFF. Power off fail- safe

Enter the system as Service Mode and type CD 10.

Then type APIMATE to enter into diagnostic and test ATC tool.

Type Set output state 00010000

Verify that the shutter was opened, The shutter Lever is the the mechanical Lever change position OPEN ("I") position. to OPEN ("1") position and the Yellow The Yellow Led is ON. Led is ON.

Power Off the Gantry.

Verify that the shutter was closed, the The shutter Lever changes mechanical Lever change position to to the CLOSE ("0") position CLOSE ("I") position and the Yellow is The yellow led is OFF. OFF.




Power off fail- safe

Enter the system as Service Mode and type CD 10. Then type APIMATE to enter into diagnostic and test ATC tool.

Type

Set output-state 00010000

Verify that the shutter was opened, The shutter Lever is in the the mechanical Lever change position OPEN ("I") position. to OPEN ("I") position and the Yellow The Yellow Led is ON. Led is ON.

Disconnect Power connector of the shutter control power cable 475-3102-02

Verify that the shutter was closed, the The shutter Lever changes mechanical Lever change to CLOSE to the CLOSE ("O") position ("1") position and the Yellow is OFF. The yellow led is OFF.

Shutter position sensors test

Enter the system as Service Mode and type CD 10. Then type APIMATE to enter into diagnostic and test ATC tool. Type Get Input-stage

Verify: Bit 3- shutter fully open Bit 3- shutter fully open (active low) = I

(active low) 1 1 Bit 4 -shutter close Bit 4 -shutter close (active low) = 0

(active low) t 0 Type Set output-state 00010000 Verify that the shutter was opened, The shutter Lever changes the mechanical Lever change to to the OPEN ("I") position OPEN ("I") position and the The yellow led is ON. Yellow Led is ON.




I ype Get Input stage

Verify: Bit 3- shutter fully open

(active low) = 0 Bit 4 -shutter close

(active low) = I

Type

Set output state 00010001 Verify that the shutter was closed, the mechanical Lever changed to CLOSE ("I") position and the Yellow Led is OFF Type Get input-stage


(active low) = 1 Bit 4 -shutter close

(active low) = 0 Type

1 1- 1

Rod motion test* 4- 4 4

Enter the system as Service Mode and type CD 10. Then type APIMATE to enter into diagnostic and test ATC tool. Type COUNTMOVE PREPREMOVE 80000 STARTMOVE Verify that the Rod starts moving towards the outer position till reaching the limit switch.


The Rod starts moved towards the outer position till reaching the limit switch.


Bit 3- shutter fully open (active low) = 0

Bit 4 -shutter close (active low) = I

The shutter Lever changes to the CLOSE ("0") position The yellow led is OFF.

Bit 3- shutter fully open (active low) = I

Bit 4 -shutter close (active low) = 0

aTTENUATION CORRECTION CHECKS and system calibration

4.3

4.3.1

BLANK SCAN ACQUISITION

Definition

A blank scan is required for each collimator in order to process the transmission scans and produce the attenuation maps. It is used to estimate the amount of attenuation being produced in the patient.

The start blank scan acquisition is a 400 second static transmission source scan with no patient or table between the transmission scan box and the detector. Because of the high count rate, the blank scan is performed using a uniform attenuating plate on the detector to reduce the detector count rate.

4.3.2 Frequency of Calibration

Blank scans should be acquired weekly before transmission scanning is performed. This also helps check the performance of the transmission hardware. A blank scan is required for each detector and each collimator used for transmission scanning. For a set of LEHR and LEGP collimators on each detector, a full set of blank scans requires four acquisitions, and takes around 30 minutes.However, if patient acquisitions using attenuation correction is not performed, or if only one collimator is used, then blank scans are not required on collimators not used for attenuation correction.

4.3.3 Procedure

Required equipment: Blank scan attenuator.

1. Fully retract the table. Fit collimators used for transmission scans.

2. Select the 'Quality Control' card, select 'Blank Scan'. Follow the instructions on the cards and enter the parameters as requested

3. Use the gantry handset to rotate the detector to face upward.

4. Adjust the Radius of Rotation to around 203mm.

5. Place the blank scan attenuating filter on the detector to be exposed as shown in Fig. 3-7.



PARAMETER ENTRY

Dr:em'J mmner I or2

AMonuator tCknoss, mir 2 Tfawmno mask wroz mm 72 or 60 for LEGPLEHR

COtiaor LEGP or LEHR Prflotu1oCiv Comctio• PMWI Ervrgy Correct on ECOR

Spalai Condclon COS?

Blank Scan Acquisition

aT-ENUATION CORRECTION CHECKS and system calibration

BLANK SCAN ATTENUATOR COVERING DETECTOR FIELD OF VIEW i

Figure 4-1. Blank Scan Attenuating Filter

6. Start the scan. This will take 400 seconds and the scan will build up on the display.

7. At the end of the scan, enter the name BSLEGP or BSLEHR for both detectors.

8. Remove the attenuator plate and repeat for the other detector.


4.4 SOURCE PROFILE SCAN ACQUISITION

4.4.1 Definition

A source profile scan is required for each transmission scan box in order to measure the uniformity of the source so that the reconstruction can produce a blank scan at the same radius of rotation as the patient scan. The acquisition is three 400 second static transmission source scans with no patient or table between the transmission scan box and the detector. Because of the high count rate, the blank scan is performed using a uniform attenuating plate on the detector to reduce the detector count rate. The three scans are performed at a minimum, maximum and central radius of rotations to cover the full length of the rod source.

4.4.2 Frequency of Calibration

Source profile scans are only acquired when the source is installed, replaced or the source filtration is changed. Each detector has a source profile which is used for all the collimators. The source profile requires three 400 second scans for each detector and takes about 30 minutes for both detectors.

4.4.3 Procedure

Required equipment: Blank scan attenuator.


Source Profile Scan Acquisition

aTTENUATION CORRECTION CHECKS and system calibration

4.5

1. Fully Retract the table. Fit only collimators for which uniformity scans are available.

2. Select 'Quality Control' card, select 'Source Profile'. Follow the instructions on the cards and enter the parameters as requested:

PARAMETER ENTRY

Deteodm mrbe I vr2

Attenu~tof th•,ness, mr 2

Colinmor LEGP or LEHR

Pmhi plier Cwmedbon PMT

E.wgy Corca.on ECOR Spaoai Correclon Co57 Unbrrwy rmcb-on LEG. or LEHR

3. Use the gantry handset to rotate the detector to face upward.

4. Adjust the Radius of Rotation to that requested on the form.

5. Place the blank scan attenuating filter on the detector to be exposed.

6. Start the scan. This will take 400 seconds and the scan will build up on the display as shown in Figure 8-7.

7. Adjust the radius of rotation as requested on the form, and repeat the scan.

8. Remove the attenuator plate and repeat the procedure for the other detector.


TRANSMISSION SCAN UNIFORMITY TEST

4.5.1 General definition

The Transmission Scan Uniformity Test is aimed to measure the uniformity of the air frame transmission image along and perpendicular to scan direction. Two performance parameters shall be measured and reported in each measurement: Transmission Scan Integral Uniformity and Transmission Scan Differential Uniformity. The measurements are dependent on consistency of the following factors: uniformity of the linear motion, relative deposition during scan of the transmission source image with respect to the transmission window, transmission window configuration and others.

4.5.2 Measurement Condition

The MG AC Option shall be properly installed and calibrated. The nominal transmission attenuation plates shall be installed.



Transmission Scan Uniformity Test

Reporting values.

4.5.3 Measurement equipment

Not applicable.

4.5.4 Measurement procedure

The measurements shall be implemented at the following rotation angles: 00, 900, 1800 and 2700.

A TOMO acquisition mode with AC option shall be activated with the following parameters:

"* Isotope:TRANS

"* Frame Size:64

"* Step time:20 sec

The transmission image shall be collected at each rotation angle.

4.5.5 Calculation and analysis

All the four transmission scan images shall be analyzed separately. The integral profile of the transmission scan image along scan direction shall be obtained inside full scan FOV. The Maximal and Minimal value of the profile distribution shall be obtained.

The percentage value of the Transmission Scan Integral Uniformity shall be calculated as

following:

Transmission Scan Integral Uniformity = (MAX-MIN)/(MAX+MIN) x 100%

The Transmission Scan Differential Uniformity shall be calculated as maximal difference between neighboring points of the profile distribution expressed as the percentage value of the average.

4.6 REPORTING VALUES.

The following values shall be reported as maximal value measured at all the rotation positions and expressed in %.

Transmission Scan Integral Uniformity < 10%

Transmission Scan Differential Uniformity <5%


CHAPTER 5 PLANNED MAINTENANCE

WARNING

The Planned Maintenance procedure must only be carried out only by a qualified service engineer authorized by the Vendor.

Planned maintenance consists of:

* Source replacement, which should be performed once per year, as described in Section 5-1. below

"* LED inspection - described in section 5.2

"* Quality Control (QC) procedures - described in section 5.3

5.1 SOURCE REPLACEMENT

Source replacement consist of the following steps, to be performed in the given order:

1. Disassembling the two Rod Units - described in Section 5.1.1

2. Dismounting the expended line source from one Rod Unit - described in Section 5-1.2

3. Mounting the new line source into one Rod Unit - described in Chapter 3, section 3.5

4. Dismounting the expended line source from the other Rod Unit - described in Section 5-1.2

5. Mounting the new line source into the other Rod Unit - described in Chapter 3, Section 3.5

6. Assembling the Rod Units - described in Chapter 3



5.1.1 Disassembling the Rod Units

1. Bring the Gantry to the H-Mode with a rotor angle of 00 a.

2. Turn OFF the Gantry.

3. Ensure that the Shutters on both rod units are closed, i.e., the lever is in the CLOSE position.

4. Remove the 3 M-6 screws holding the Rod to the Rod Holder and carefully place it on a firm flat surface

5. Switch ON the Gantry.

6. Rotate the Gantry to 2250 to facilitate removal of the second rod unit.

7. Switch OFF the Gantry and repeat steps 3 and 4 to remove the Rod from Head #2.



Planned Maintenance Source Replacement


5.1.2 Dismounting the Expended Line Sources

Each expended 153Gd Line Source must be extracted from the Rod Unit into an empty Lead-Shielded Source Container according to the instructions below.

1. Place the stored empty Source Containers and the Aluminum Plunger next to the removed Rod Units.

2. Remove the Cover Plate from the Rod Unit by unscrewing its two fastening Allen screws (see Figure 5.1).

Source Holder Securing Screws

Cover Plate /

Figure 5-1. Rod Unit with Cover Plate Removed

3. Similarly, remove the Cover Plates from both sides of the Source Container by unscrewing two fastening Allen screws per cover (see Figure 5.3).

- Location a 'late Securing

Pistor

urn Source Container /

Ef Container - Rod tMien Screw Alluminum Plunger

Figure 5-2. Source Container

4. Release the two screws which secure the Source Holder inside the Rod Unit (see Figure 5.1)



w Cover F

733117T=ýý -----------


Ledmine lri

5. Hold the empty Source Container in vertical position, shake it to slide the piston outwards, and then replace it on the table. Insert the rectangular end of the Plunger into the top of the piston protruding from the Source Container. Holding the protruding section firmly, secure the fastening nut in a CW direction (Step 1 in Figure 5-3).

6. Push the plunger half the way in Step 2 in Figure 5-3).

7. Line up an empty Lead-Shielded Source Container to the Rod Unit, using the locating pin protruding from the Source Container to ensure correct alignment with the Rod Unit (see Step 3 in Figure 5-3).

8. Secure the empty Source Container to the Rod Unit, using one of original screws removed at Step 3, above (see Step 4 in Figure 5-3).

9. Push the Plunger all the way in, and carefully turn the plunger fully CW (Step 5 in Figure 5-3).

10. Pull out the Plunger, extracting the source holder from the Rod Unit into the Lead-shielded Source Container (Step 6 in Figure 5-3).

11. While holding the Piston, remove the Plunger by turning the fastening Nut CCW.

12. Reassemble the Cover Plate on the free end of the Source Container.

13. Disassemble the Source Container from the Rod Unit (Step 7 in Figure 5-3).

14. Reassemble the Cover Plate on the other end of the Source Container.

15. Discard the source container with the expended source as per the local regulations for radioactive materials.



A WARNING Disposal of the used line sources must be In accordance with the

regulatory procedures. Only GE trained personnel or someone licensed by NRC or State agreement are considered suitable for source disposal



0

Figure 5-3. Extracting the Line Source From the Rod

MG ATC Service Manual P.N. 490-3201-01 5-5

Rev. No. 0 December 1998


10 Olor

Planned Maintenance Led Inspection

5.2 LED INSPECTION

1. LED inspection should be performed every six months

2. Perform Tomo acquisition with AC option and verify that the LEDs on both rods illuminate during linear scanning.

5.3 QC PROCEDURE

The procedures for weekly QC are described in section 4.3 and section 4.4. In addition to the weekly QC, a quarterly QC (every four months) should be conducted.

a. Fully retract the table. Fit a set of collimators for which uniformity scans are available

b. Select the Quality Control card. Select Transmission Scan Uniformity Test and follow the instructions displayed.

c. Verify that the reported results of the Transmission Scan Integral Uniformity and Transmission Scan Differential Uniformity comply to the required values.

MG ATC Service Manual P.N. 490-3201 -01


Planned Maintenance Led Inspection

EL OEMS MG ATC

MG ATC Rod Unit

Appendix D DuPont Pharmaceutical Data

ATCNRCAPPD.DOC D-1

FpX:978 663 0351 PAGE 1FILE No.467 01/29 '99 15:36 ID:DUPONT MERCK SOLRCES

DuPont Pharmaceuticals Company

FACSIMILE- TRANSM ISSION

To: Dr Leonid Tsukerman

Company: ELGEMS

FAX No.: 972 4 8577662

Date: Jan. 29, 1999

No. of Pages: 9 (incl. cover sheet)

From: Ron Brown

Company: DuPont Pharmaceuticals

Phone No.: (978) 671-8000

FAX No.: (978) 663-0351

EMAIL: ronaid.c.brown@ dupontpharma.com

Re: Gd-153 Source Questions per your e-mail of Jan. 27

As promised I have enclosed the item I referred to in my e-mail response of today. Please let me know if I can be of any further help.

If this message is received incomplete, please call 800-362-2668, ext. 8450.

D-2.

FILE No.467 01/29 '99 15:36 ID:DUPONT MERCK SOURCES

January 28, 1999

To: Ron Brown

From: John Sumares

Subject: Information on Gd-153 Line Sources

The following information may be provided to 'Elgems' in order for NRC to complete the evaluation of their line source holder.

Three small amounts of '3M' #2216 epoxy are used to fix the source into its holder. The locations of the epoxy are one at each end and one in the middle of the source. The total absorbed dose to the epoxy at each end of the line source is calculated to be 2 X 10E05 Grays over the service life of the line source. The total absorbed dose to he epoxy in the middle of the line source is calculated to be 6 X

,'.4E05 Grays over the service life of the line source. These calculations have the following assumptions:

1. The maximum activity for the line source is 540 mCi in 20Q

active length

2. The amount of epoxy is - 15 milligrams

3. The expected life of the source is 5 years

The total absorbed dose for the epoxy at the source ends and in the middle are below the limits for previously evaluated '3M' #2216 epoxy. There is no existing technical literature for the radiation resistance of the epoxy, however, the approved NER-462 Fe-55 source evaluation contains irradiation test results of the epoxy after 2.5 X 10E07 Grays of Sr-90/Y-90 beta radiation. This safety evaluation of the Gd-153 line source design qualifies the use of '3m' #2216 epoxy for bonding the source to the holder.

D-3

FP•X:g?8 663 0351 PAGE 2

KtGE 3FILE No.467 01/29 '99 15:37 ID;DLPONT MERCK SOURCES FX986305

06/11/1998 10:40 6177272e8S RADIATION CO3NTROL

REG;ISTpRy or RADIOACTIVE SMAED SOURCES AN4D DEVICES SAE~ETY vL'UATIOX OF SOURCE:

(Amended in its Ent~rety)

N~O: MA-0476-S.-117.S

SOURCýE TYPE: TrCanSI~i .siofl

DATE: 6/11/98

Line Source

PAGE: 1 Of 5

MOIDEL: NES-6412 , N4ES-8422 through 2NEs-8426, NES-842

9

MANFACTURER/ DISTRIBUTOR:

ISOTOPE:

LMJ4K TEST F. 0 t 1C Y

PRINCIPAL ýUSK: (W Medical Radiography

CUSTOM SOURCE: ____ YES X

Du Pont M~erck Pharmaceuticals Radiopharmaceuticals Djivisonl

331 Treble Cove Road N. Billerica, MA 01862

MAXIMUM ACTIVITY:

1000 Tmillicurie3 (37 GBq)

6 Months

NO

PAGE 01

FAX:978 663 0351

06/11/1998 10:40 6177272898 RADIATION CONTROL PAGE 82

REGISTRY'OF RADIOACTIVE SEALED SOURCES AND DEVICES

'SAFETY EVALUATION OF SOURCE (Amended in its Entirety)

NO: MA-0476-S- 1 1 7 -S DATE: 6/11/98 PAGE: 2 of .5

SOURCE TYPE: Transmission Line Source

DESCRIPTION:

The sources consist of radioactive Gd-153 uniformly i.ncorporated

into an ePOWy matrix. The Gd-153/epoxy is contained in a stiinless

steel or polymer inner tube, then inserted into a stainless steel

outer tube. Two stainless steal Gnd plugs are epoxy glued onto the

snds of the outer tub to form the encapsulation. For the Model

L.AES-S425 each end plug features a 6-32 UNC threaded hole for

attacbmient to a source holder.

ERaviewer notes: 1. This certificate no longer describes a lead storage tube which

would act as the source holder in a medical ganma camera

sys tern. 2. Refer to the medical gamna camera system device registration

certificate for soUZre holder configuration informat-On. ]

.The model number uniquely designates the active length, active

diameter, and maximum activity according to the following table:

Maximum Activity Active Dia. Active Length

Model Number (m.I•-licules /GB=,, (,nchesl'/m) (.nrches/cm)

NES-e412 300/11.1 0.06/1.52 20.00/50.8

NES-8422 500/11•5 0.0611.52 18.18/46.12

14ES-8423 600/22.2 0.06/1.52 iS.16/46.12

NES-e424 200/7.4 0.06/1.52 6.72/22.3

NES-8 4 2 5 400/14.8 0.17/4.32 9.25/23.5

NES-8426 30/1.11 0.06/1.52 7.75/19.7

.NES-6429 600122.2 0.0611.52 20.00/50.!

LABELING:

Each source is engraved with the model number, isotope, activity,

serial number, month and year of assay, and serial number.

D-5

FX:978663 0351 PA.GE 4FILE No.46-' 01/29 '99 15:37" ID:DUPONT MERCK SOURCES

FILE No.467 01/29 '99 15:37 ID:DrPC MERCK S(J.RCES FAX:978 66 0351 PAGE 5

06/11/1999 10:40 6177272098 RADIATION CONTROL PAGE e3

REGISTRY OF pRADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SOURCE

(Amended in its Entirety)

NO: MA-70476-S-I1 7 -S DATE: 6/11/98 PAGE: 3 of 5


DIAGRAM:

See attachments 1 and 2.

CONDITIONS OF NORMAL USE:

•-hese sources are designed for use as a component of a medical

.- gamma camera system used in the nuclear medicine department of a

hospital or clinic. Therefore, during normal use, the source will

be subjected only to controlled conditions suitable for human

occupancy. Extremes in environmental or operating conditions are

not expected to exceed normal room temperature and humidity

fluctuations. The useful life of the source is approximately five

years.

PROTOTYPE TESTING:

A prototype of the source design was tested in accordance with the

specifications of ANSI N542-19 7 7 and the design achieved an ANSI

classification of 77C32314.

EXTEP-NAL RADIATION LEVELS:

The characteristic radiation levels from the sources are listed in

the table below:

Distance Radiation Level

(inches/cm) (mnfhr/mCi)/ J(Sv/hr/MIq)

contact 21/5.25 1.97/5 2.1/0.525

11.8/30 0.6/0.15

The radiation level at the ends of the line source was measured to

be 2.4 mR/hr/mCi (0.6 IASv/hr/MBq).

D-6


86/11/1998 10:40 6177272098 RADIATION CONTROL PAGE e4

REGISTRY OF 1ADOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SOURCE

(Amended in its Entirety)

NO: MA-0476-S-117-S DATE: 6/11/98 PAGE: 4 of 5


QUALITY ASSURANCE AND CONTROL:

The sources are manufactured and distributed under the guidelines bf Pu Pont Merck Pharmaceutical Company's quality assurance and

control program. The program has been deemed acceptable for

licensing purposes by the U.S. Nuclear Regulatory Commission (NXC). A 'copy of the program is on file with the Commonwealth of

(.jlassachusetts, Radiation Control Program.

LIMITATIONS AND/OR CONSIDERATION OF USE:

The sources are to be distributed to persons specifically licensed by the Commonwealth of Massachusetts, NRC, or an

Agreement State.

The sources shall not be subjected to environments which exceed their ANSI N542-1977 classification 77C32314.

The sources shall be leak tested at intervals not to exceed 6

months using techniques capable of detecting the presence of

0.005 microcurie (185 Bq) of removable contamination.

Handling, storage, use, transfer, and disposal: To be determined by the licensing authority.

LJThis registration sheet and the information contained within the

references shall not be changed without the written consent of the

Commonwealth of Massachusetts Radiation Control Program.

SAFETY ANALYSIS SUNMMARY:

Based on a review of Models NES-8412, NES-8422 through NES-8426,

and NES-8429 sealed sources, and the information and test data

cited, we continue to conclude that these sealed sources are

acceptable for specific licensing purposes. Furthermore, we

continue to* conclude that the *ealed sources would be expected to

maintain their containment integrity for "normtal conditions of use

and accidental conditions which might occur during uses specified

in this certificate.

FP.X:978 663 0351 PAGE 6


06/11/1998 10:40 6177272098 RADIATION CONTROL

REGISTRY OF RADIOACTIVE SEALED SOURCES AM DEVICES SAFETY EVALUATION OF SOURCE

(Amended in itz Entirety)

NO: MA-0476-S-11 7 -S DATE: 6/11/98 PAGE: 5 of 5.


REFERENCES:

The following supporting documents for the Models NES-8412, NES8422 through NES-8426, and NES-8429 sealed sources are hereby incorporated by reference and are made a part of the document.

* Du Pont Merck letters dated December 6, 1995, and August 1, 1996, with enclosures thereto.

Du Pont Merck facsimiles dated May 8, 1996, April 23, 1996, and November 13, 1996, with enclosures thereto.

Du Pont Merck letters dated January 22, 1998, and May 26, 1998, with enclosures thereto.

ISSUING AGENCY:

Massachusetts Department of Public Health, Radiation ControlProgram.

Date: ; /i

Q '/ Date:

Reviewer;

Concurrence: Ag stin aat o

p-8

PAGE 05

F.X :978 663 0351 PAGE 7

FILE No.467 01/29 '99 15:38 ID:DUPONT MIERCK SOURCES FAX:978 663 0351

e6/11/1998 10:40 6177272098 RADIATION CONTROL

REGISTRY OF RPDIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SOURCE

NO: MAO-0476-S-117-S DATE: 6/11/98 Attachment: 1


PAGE 8

PAGE 06

FILE No.467 01,29 '99 15:38 ID:DUPONT MrERCK SOURCES FPX:978 663 0351

06/11/1998 10:40 6177272098 RADIATION CONTROL

NO: MA-'

REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SOURCE

0476-5-117-S DATE; 6/11/98 Attac

PAGE 9

PAGE 07

:bment : 2

6-3z Nc a2X tr•

A s 9

"-4.6I *g= 3

dý4~ I~.

%@trd Ik

C3U7--0 Do N.)

4� -- s�a,

CKC NJ

P/N-'OP EME P1Ur csmtaso Mll 104 ZI•rLA"= IrC~L

NES-8425 Source

UK 2 x . =P

EL6EMS MG ATC

MG ATC Rod Unit

Appendix E - Labels

ATCNRCAPPE.DOC E-I

EL OEMS

Contents

MG ATC Rod Unit labels Identification WARNING label MG ATC SER. No. label MG ATC OPEN/CLOSE label Copy (not in scale) of DuPont sealed s Source container ( ZVIL ) label assy ZVIL ( Source Container) label

MG ATC

drawing No. 705-3201-0010 drawing No. 705-3671-0901 drawing No. LBL000343 drawing No. 705-3685-5102

ource shield label drawing No. 119200001 drawing No. 705-3671-1008

ATCENRCAPPE.DOC

Page

E-3 E-4 E-5 E-6 E-7 E-8 E-9

E-2

C

F- 3

C

No NAME PART NUMBER

1 Warning Label 705-3671-0901

2 Serial Number Label L.BL. 000 3•3

3 OPEN I CLOSE Label 705-3685-5102

ELGEMS MG ATC ROD UNIT LABEL IDENTIFICATION

Drawing Number 705-3201-0010

nl ! •o

ZONE OESCRIPTION APPR. DATE REV CHANGE ORD.

NEW DOCUHENT ._ 08.06.1995 0 P9532017

R=5 TYP

C C

"*1 WARNING: &4

RADIOACTIVE MATERIAL ENCLOSED 15 3 Gd MBq on 1 705-3671-0901

150

-I

1. MATERIAL - L EXA'. " .3 0. Y

2.FONT - DA' CGRAY PA.7-•,^,-4d

.3. BACKGROUND L IGH- G4A" A,\iTO.,- ,27

4. -TRANSPARENT

5 ADHESIVE: MAC-TAC COVER BY PAP.EP

0-.C TESTS OF 15 SECONDS RU'B I'NG WI TH I SO-PROPANOL AND METHANOL

AFTER ADHESION INSPECT T-AT THE TEXT IS READABLE A.V-, CLEAR AND THAT THE BORDER5 OF T7."E LABEL

ARE NOT FOLDED

NAME DATE EUROPEAN PRO.ECTION. EOUIPMENT ASSEMBLY NAME

DESIGNER WAINER I 'ro 21.05.9 DIMENSIONS WSI1K'OX..S0F I A •,,•21. 05.9., FINISH CHECKER YOHA A. t7-3 08.06.9,' NO -, I t V ' I ! l tI , APPROVAL WV B. 1 08.06.9 F SCALE NAME

1.0:1.0 WARNING LABEL

COSTS LrfEPCW LTD. TOL.NOT SPECIFiEO 0.5 CRAWING No.

550 ~710,51-F36711-091 .o.,. 5ST OP.6-09101

HAIFA 30O0 ISRAEL NEXT OP. IsHEET OF YER.C(. REV.

/doc.JI."mVo71O9Q1.00q 0-PJmr-5 10:5w

i-

ZONE DESCRIPTION APPR. DATE REV CHA\•E CRO.

SNEW DOCUMENT 0

I ____________________

150

1. MATERIAL - LEXAN 0.3 MM

2.FONT - DARK GRAY PANTONE 446

3. BACKGROUND LIGHT GRAY PANTONE 427

4.M -TRANSPARENT

5 ADHESIVE: MAC-TAC COVER BY PAPER

0.C. TESTS OF 15 SECONDS RUBBING WI TH WATER. ISO-PROPANOL AND METHANOL AFTER ADHESION INSPECT THAT THE TEXT IS READABLE AND CLEAR AND THAT THE BORDERS OF THE LABEL

ARE NOT FOLDED

ELGEMS PART No. LBLO00343

NAME I DATE EUROPEAN PROJECTION. EQUIPMENT ASSEMBSY NAVE

:SIGNER ANY A. 26.12.9i DIMENSIOS Idef.: M4 M CEG MG-ATC 0Z--- ,- .9Z FINISH M G A T M~iGN ONZ ANYA. 28.12.9FNS o

Z BENN H. N ._,1,

A"ROVAL ISRAEL S. VF SCALE NAME I_______o,,c,.•o~s, o-o s.,.. 1.0:1.0 MG-ATC ROD SER. No LABEL CONTENTS'PROPERTY CF ELGEMS .LTD. TOL.NOT SPECIFIED .:10M -T RO SE N LA L N~O UNA. -ORIZEO USF PERM.ITT0.

lw-IEDAWING No.

Po , LA.sT oP. -1.." 0. L o P

Tirat Israel NEXT OP. SHEET OF VERS. C-<. -V.

Projecl : CET-2. Item : L.8000343. 28-Uor-99 08:21

ZONE OESCRIPTINN APPR. CATE REV CHANGE ORD.

NEW DOCUMENr _" 0

ru') p,,"



J. BACKGROUND LIGHT GRAY PANTONE 427


o.C. TESTS OF 15 SECONDS RUBBING WITH WATER, ISO-PROPANOL AND METHANOL AFTER ADHESION INSPECT THAT THE TEXT IS READABLE AND CLEAR AND THAT. THE BORDERS OF THE LABEL

ARE NOT FOLDED

NAME DATE EUROPEAN PROJECTION. EQUIPMENT ASSEMS.V NAME

DESIGNER OANY A 28.12.9 DEFAULT OIMENSIONS : M.

CSc0ir. MI. 0 128.12. FINISH CHECKER 8ENN H. SCALE'A.E

APPROVAL ISRAEL S. SCALE NAME

1.0:1.0 V-TARANSACT OPEN/CLOSE LABEL C.,TEN S PUP•C RTY OF ELGEMS LTD. SPECtF

UNAUT;RIZO USE PEqi4TTT5. ..,sIzE DRAWING No.

PoeLAS CP 7051 % ,.511 S r:( R P0s t 70K T ,aot Rao'~m. 0200 Israel NEXT CP. i SE-' S c- V

Proiect : V-TRANSACT. It= : lock-label. 24-Feb-98 13:16

Transmission Line Source _ NES 8429 Radionuclide: Gd-153 o Activity: 450 mCi Date: XX/XX Z I I Lot Num=ber: S8429XXX-GXXXX

Soo Produc= Infornation Shwt for tafety and handling information 4

..

DL

C

03

C

No. Name PIN

1 ZVIL Label 705-3671-1008

ELGEMS

V-TransACT Zvil Unit

Labels Assembly

Drawing No. 119200001

zc. E CESCRIPTICN APPR. I oATE REV CMA.Gc- -RO.

NEW DOCUMENT "_ _ oI _ _ ~I I. _ _ - _

R=5TVl

MOUNT THI0 OIDE TO ARM EZI�\, 705-3671-1008

150



3. BACKGROUND LIGHT GRAY PANTONE 427

4. M - TRANSPARENT


0.C. TESTS OF 15 SECONDS RUBBING WI TH WATER, ISO-PROPANOL AND METHANOL AFTER ADHESION INSPECT THAT THE TEXT IS READABLE AND CLEAR AND THAT THE BORDERS OF THE LABEL

ARE NOT FOLDED

'NAME DATE EUROPEAN PROJECTION. EQUIPMENT ASSEMBLY NAME

OSS -,NER OANY A. 05.11.9 :EFAULT OIKENSIONS : .

ES;C4::":-.I DANY A. 05.11.91 FINISH

CHE:4E= GILAD 14.11.9 APPR:VAL 00V B. 14.11.9 SCALE NAME

v 1.0:1.0 ZVIL LABEL C.'%*--.TS FR.^;0=.RTT OF --'•63EMS LTD. TOt..NOT SP'C IF'lEO "

CS, or- 1 US-_- __Iw * 10CC IZ E DRAW;.N; -a

LAST 3P 17,0 11;11 __lj ___

rip Ho0 me. 0200 Isroo NEXT OP. ISHEES .

Project : CET-2. Item : zvil-lobel. 18-Jon-98 08:24 _

EL fEMS MG ATC

MG ATC Rod Unit

Appendix F- Radiation Measurements

ATCNRAAPPF.DOC F-!

EL OEMS MG ATC

Contents Page

Transmission Source Rod Radiation Profile Test F3-FI I Patient Exposure Test F12 Radiation Exposure For Workers and other Personnel F13 Radiation Leakage from the Transmission Source Shipping Container F14

ATCNRAAPPF.DOC F-2

ELscint General Electric Medical Systems 1LOE ~S ELGEMS Ltd. a P.O. Box 170 e Tirat Hacarmel 30200 ISRAELTEL: 972-4-972-44563660@ FAX: 972-4-8577662

Dr. Leonid Tsukerman, PHONE: 972-4-8563659, EMAIL: LEONIDTSUIERMAN(@ELGEMS.COM

MG ATC

Transmission Source Rod Radiation Profile Test.

REPORT

Prepared and approved by Dr. Leonid Tsukerman, Senior Physicist, Radiation Safety Officer

18 March 1999

Preface

Radiation Profile Test of the two 450mCi Gd-153 transmission radioactive sources was performed on March 1Oth 1999. The test is aimed to measure the radiation exposure obtained from MG ATC transmission sources.

The radiation measurements for iso-distances were carried out with using two radioactive sources simultaneously and reflected the superposition of the radiation exposure obtained from the both sources.

One should notice that transmission rod was designed and manufactured as beam limited device. The cross-sectional profile of count density seen on detector face (image below) is acquired without detector collimator with line source held fixed in an exposed position.

Measured sources profile full width at half-maximum (FWHM) and full width at tenth maximum (FWTM) values were 5.9 cm and 10.8 cm accordingly. So, transmission beam can be considered as spatially limited.

Test Method:

The radiation measurements were performed using BICRON Micro SievertTM meter (Rate range - lIAR~h...200mR/h; Energy lower limit - 17keV). The meter was calibrated by BICRON on Jul 1998. Next calibration due July 1999. As a weaker (decayed) source is used, the results are corrected to apply for a 450 mCi nominal source activity. Background radiation was measured for each set of the measurements by placing the meter at 3 meters from the system under test.

Each set of the radiation profile measurements was carried out on two perpendicular planes: transmission radiation plane (including in-beam and out-beam measurements) and source scan plane. No brass filter strips were used in the measurements.

The measurements were performed with shutter in both the open and the closed position:

Shutter Open:

1. In-Beam exposure measurements inside transmission field of view

Measurements were taken inside transmission field of view (between rods and detectors) in the same plane (transmission plane) as the line sources were positioned (Figure 1). Both transmission rods were moved to the center of the transmission field of view. The relative displacement between 1 and 2 source position was less than 2

umm. The positions of the reading indicated the center of the detector chamber of the exposure meter. The measurements were performed at different distance from the source holder external surface: 5, 30 and 60 cm.

2. Out-Beam exposure measurements inside and outside transmission field of view

The 2 sets of measurements were carried out, when transmission rods were moved to the outter and inner border of the transmission field of view. In both rod positions, the measurements were taken inside transmission field of view (Figures 2 and 3) at 5 cm outside the transmission plane and at different distance from the source holder external surface: 5, 30 and 60 cm. The measurements outside transmission field of view (Figures 4 and 5) were taken at distances: 5, 30 and 100 cm from the source holder external surface.

Shutter Closed - Radiation Leakage Measurements:

Both transmission rods were moved to the park position. Measurements were taken inside area between rods at distances 5, 30 and 60 cm from the rods external surface as well as outside at distances 5, 30 and 100 cm (Figure 6).

Test Results:

1. In-Beam exposure measurements inside transmission field of view

Figure 1 shows the radiation exposure rates measured inside transmission field of view in the center of the radiation beam. The maximal exposure rates at distances of 5, 30 and 60 cm are shown in the table below.

Distance to rod external surface Measured Exposure Rate [cm] [mR/hi

5 55.7 30 50.4 60 32.5

The additional measurement was carried out in order to find the point of maximal exposure rate. Maximal radiation exposure of 55.9 mR/h was detected at the distance of 25 cm from each rod. It is the minimal distance when superposition of radiation flux from both rods becomes effective.

2. Out-Beam exposure measurements inside and outside transmission field of view.

Figures 2,3 and 3,4 show the radiation exposure rates measured inside and outside transmission field of view, accordingly. All the measurements were carried out outside the radiation beam. For all the cases the maximal radiation exposure of 0.06 mR/h was detected at the distance of 30 cm at the front end of each rod. Typical value of exposure rate was 0.03 - 0.04 mR/h inside the field of view and 0.02 -0.03 mR/h outside the field of view. The results of the Out-Beam exposure measurements are very closed to background radiation and confirm the radiation beam is spatially limited.

3. Radiation Leakage Measurements

Figure 6 shows the radiation leakage measured inside and outside transmission field of view. The maximal value of the radiation leakage of 0.05 mR/h was observed at the distance of 5 cm at the front end of the both rods. At distance of 100 cm and more the radiation leakage is less than 0.01mR/h and considered as negligible compared to background.

F-S

C C

Distance from the Source Rod 15 cm 30 cm 60 cm

Figure 1. MG ATC System Radiation Measurement Results(Shutter Open): In-Beam Exposure Rates Measurements were taken in the same plane(transmission plane) as the line sources were positioned. The relative displacement between I and 2 source position was less than 2 mm. Exposure Rate is expressed in [mR/hi. The positions of the reading are shown where the center of the detector chamber of the exposure meter was placed. When measurement was done, the sources had decayed down to 297 mCi, therefore the exposure rate values were scaled to raise source activity to equivalent of 450 mCi. No filter strips were used in the measurements. Background radiation was measured of 0.004 mR/h.

60 cm

N 19

A 30 cm 5

5 cm

M

C C

Distance from the Source Rod 1

5:tm 30 cm 60 cm 5 cm

/ IDetector 1 ," I Detector 1

60 cm ... ....-. . ... . .... ..... ... .. ....... ...... .

fqf

- - -, - -- -;

'aI I

• .* jI S30 cm

-4 I

S0.02 1 003 W 3Detector 2 5 cm • o . . . . .I. . . ... ... . . . . . . . . .. . . . . . . . . .

\ ~ ~~~So,,rce Rod 2......_

Transmission field of view,

Figure 2. MG ATC System Radiation Measurement Results(Shutter Open): Inside Transmission Field of View Out -Beam Exposure Rates

The transmission rods were moved to the outter border of the field of view. Measurements were taken inside field of view and 5 cm outside the transmission plane. Exposure Rate is expressed in [mRih]. The positions of the reading are shown where the center of the detector chamber of the exposure meter was placed. When measurement was done, the sources had decayed down to 297 mCi, therefore the exposure rate values were scaled to raise source activity to equivalent of 450 mCi. No filter strips were used in the measurements. Background radiation was measured of 0.004 mR/h.

C

Distance from the Source Rod I5cm

Figure 3. MG ATC System Radiation Measurement Results(Shutter Open): Inside Transmission Field of View Out -Beam Exposure Rates

The transmission rods were moved to the inner border of the field of view. Measurements were taken inside field of view and 5 cm outside the transmission plane. Exposure Rate is expressed in (mR/h]. The positions of the reading are shown where the center of the detector chamber of the exposure meter was placed. When measurement was done, the sources had decayed down to 297 mCi, therefore the exposure rate values were scaled to raise source activity to equivalent of 450 mCi. No filter strips were used in the measurements. Background radiation was measured of 0.004 mR/h.

C

5 cm

Detector 1

0

Detector 2 - - -. -. -. . -.-.. .. . .

30 em 60 em

'11

0Z3

60 cm 14

0

o

a 30 cm C

5cem

C C

Distance from the Source Rod I

5 cm :I

30 cm

I I

100 cm

Detector 1

I ----------- LLDetector 2

Figure 4. MG ATC System Radiation Measurement Results(Shutter Open): Outside Transmission Field of View Out -Beam Exposure Rates

The transmission rods were moved to the outter border of the field of view. Measurements were taken outside field of view and 5 cm outside the transmission plane. Exposure Rate is expressed in [mR/h]. The positions of the reading are shown where the center of the detector chamber of the exposure meter was placed. When measurement was done, the sources had decayed down to 297 mCi, therefore the exposure rate values were scaled to raise source activity to equivalent of 450 mCi. No filter strips were used in the measurements. Background radiation was measured of 0.004 mR/h.

100 cm

(0U,

• 30 cm U 0

5 cm

5 cm

0

S

11

ram.

- - - - - - - - --

U

I

C C

Distance from the Source Rod I

5 em

Figure 5. MG ATC System Radiation Measurement Results(Shutter Open): Outside Transmission Field of View Out -Beam Exposure Rates

The transmission rods were moved to the inner border of the field of view. Measurements were taken outside field of view and 5 cm outside the transmission plane. Exposure Rate is expressed in [mR/hi]. The positions of the reading are shown where the center of the detector chamber of the exposure meter was placed. When measurement was done, the sources had decayed down to 297 mCi, therefore the exposure rate values were scaled to raise source activity to equivalent of 450 mCi. No filter strips were used in the measurements. Background radiation was measured of 0.004 mR/h.

100 cm

0

V e4

U

S30 cm

S I'I

$ ¢

Detector 1

Detector 2

I I

5cm Oem 5cm

.0.01

0.03 0.03:' 0 *0.04 I

.I ....

.0.021 * Detector I 0.01

I.0.01.

- - - - . I - -. L.

I.

.0201 38 60 1 0 .0 1 ....... 0.01 ..... 0.01

0 5 0 . .. .. . . .. . . ........... .......... ..

0.01 t. , 00

0.0 0.03 .. 00 .0. *00 0.001

0 01. .010.*00. .ii* .3 . ... 00 i ... 0.03 ,i , .. o. o .. 2 .. •, .0 0.05. .~2 ..... . .. ..

0.05. i 10.0.02 o 0.02 1 0.020 4

* *~. I00.0

0.01 0 .0.01 6 ITransmlsslon field of viewl

0.010 A' • .. ;: . . 01 O.l0 .Ol0 0.010

30 cm 5 cm em 100 cm

0

0.01 0

0.01

0.02

0.03 0.0,2.+

o.04 "

* 1:30cm

0.061 00.0130fcm5cm0cm s5cm 30 cm

Figure 6. MG ATC System Radiation Measurement Results(Shutter Closed): Leakage Exposure Rates The transmission rods were moved to the park position. Measurements were taken inside area between rods at distances 5, 30 and 60 cm from the rods external surface as well as outside at distances 5, 30 and 100 cm. Exposure Rate is expressed in [mR/h]. The positions of the reading are shown where the center of'the detector chamber of the exposure meter was placed. When measurement was done, the sources had decayed down to 297 mCi, therefore the exposure rate values were scaled to raise source activity to equivalent of 450 mCi. No filter strips were used in the measurements. Background radiation was measured of 0.004 mRAi.

30 cm

C>30 cm

C

0 o .o . ...........0 i * 0.0 ................ 0 o.03 0.05

n.1 0.01

100 cm

:0.01 0

0.01.

100 ci

S30 cm

O.01* 5 cm

0.01:. . 30cm

5 cm

0.01 6 0 cm

S5'cm

R

0.0s•~4 0o.01... • .o3 . ...... Detector I

I

/I ' jJ.2 I .0.02. .0.01. .. .1

Sit

0.03 0.041 Detector 2 • *0A.fl• .... ; . ..

m100 cm

100 cm

i i

- v • ml•

4

ELscint General Electric Medical Systems ELGEMS Ltd. e P.O. Box 170 e Tirat Hacarmel 30200 ISRAEL e TEL: 972-4-972-4-8563660. FAX: 972-4-8577662

Dr. Leonid Tsukerman, PHONE: 972-4-8563659, EMAIL: [email protected]

MG AC Project

Patient Exposure Test.

REPORT

Tuesday 15 December 1998

Patient Exposure Test of the 450mCi Gd-153 transmission line source of the MG AC option was performed on Nov 15, 1998.

Test Method:

The measurements were performed using BICRON Micro Sievertm meter (Rate range - lI R/h...200mR/h; Energy lower limit - 17keV). The leakage meter accuracy is ±20%. The leakage meter was calibrated by BICRON on Jul 1998. Next calibration due July 1999.

The radiation exposure rate measurements were carried out in the center of the radiation beam at distance of 50 cm from the both sources. As a weaker (decayed) source is used, the results are corrected to apply for a 450 mCi nominal source activity.

Test Results:

The results of the test demonstrate the radiation exposure rate of 30.4 ± 0.4 mR/h in the center of the radiation beam at distance of 50 cm from the both sources.

Dr. Leonid Tsukerman, Radiation Safety Officer.

F- 4Z

ELscint General Electric Medical Systems ELGEMS Ltd. e P.O. Box 170 a Tirat Hacarmel 30200 ISRAEL. TEL: 972-4-9724-8563660a FAX: 972-4-8577662

Dr. Leonid Tsukerman, PHONE: 972-4-8563659, EMAIL: LEONIDTSUKERMAN@,ELGEMS.COM

MG AC Project

Radiation Exposure for Workers and other Personnel

REPORT

Wednesday 23 December 1998

Radiation exposure for workers and other personnel of the 45OmCi Gd-153 transmission line source of the MG ATC option was estimated on basis of the test implemented on Dec 07, 1998.

Test Method:

The radiation measurements were performed using BICRON Micro SievertTm meter (Rate range - 1 gR/h...200mR/h; Energy lower limit - 17keV). The leakage meter was calibrated by BICRON on Jul 1998. As a weaker(decayed) source is used, the results are corrected to apply for a 450 mCi nominal source activity.

Test Results:

The source is only open during source exchange procedure. The maximal exposure to the hand of the worker (for 10 sec exchange) is less than 0.04 mrem and typically 0.01 mrem.

For workers and other personnel the dose is minimal : the source is contained all the time inside the radiation shielding of the source holder (radiation leak is less than 0.1 mrero/hour).

Leonid Tsukerman, Ph.D. Radiation Safety Officer.

F-13

ELr.FMS ELscint General Electric Medical Systems ELGEMS Ltd. * P.O. Box 170 * Tirat Hacammel 30200 ISRAEL. TEL: 972-4-972-4-8563660. FAX: 97244577662 Dr, Leonid Tsukerman, PHONE: 972-4-8563659, EMAIL: [email protected]

MG AC Project

Radiation Leakage from the Transmission Source Shipping Container.

REPORT

Monday 28 December 1998

The measurements of the radiation exposure rate of 450 mCi Gd-153 line transmission source shielded into the MG AC lead shipping container were performed on Dec 06, 1997.

Test Method:

All the radioactive measurements were performed using BICRON Micro SievertTM meter (Rate range - 1 pWR/h...200mR/h; Energy lower limit - 17keV). The leakage meter was calibrated by BICRON on Jul 1998. As a weaker (decayed) source is used, the results are corrected to apply for a 450 mCi nominal source activity.

The measurements were implemented at contact handling to shipping container at the center, front and rear side. The maximal values of dose rate are recorded. The results of the measurements are corrected on the source decay.

Test Results:

Measured Value Decay Corrected Value Background 0.004 ± 0.001 mR/h 0.004 ± 0.001 mR/h Front end 0.007 ± 0.001 mR/h 0.009 ± 0.001 mR/h Rear end 0.006 ± 0.001 mR/h 0.007 ± 0.001 mR/h Center 0.005 ± 0.001 mR/h 0.006 ± 0.001 mR/h

Conclusion:

The results of the measurements comply to transmission line sources shipping container design specification.

Note: The shipping cardboard box is type A package.

Leonid Tsukerman, Ph.D Radiation Safety Officer. -4

F- 4L

ELMOEMS

MG ATC Rod Unit

Appendix G - Prototype Testing

ATCNRCAPPG.DOC

MG ATC

G-1

EL EMS MG ATC

Contents Page

General G2 Radiation Leak Test G2 MG ATC Rod Shutter Test Report G3-G7 Effect of Basic Transportation (vibration) on Transmission Line Source Radiation Leakage G8-G14 Transmission Rod Unit Drop Test Report G15-G16

General

The purpose of the following tests performed on the Rod source and its operability was to ensure that during normal use conditions over the expected life of the housing, the byproduct material ( Gadolinium 153 ) will not be released to the environment, and the source will not be inadvertently unshielded.

The transportation of the device and the source container to the site is done separately. The device, not including the line source, is transported from the device manufacturer (ELGEMS). The source container, which includes the source holder with the line source glued, is transported from the source MANUFACTURER (DuPont Pharmaceuticals) to the site, on a shipping box in compliance with U.S. Department of Transportation packaging specifications for USA DOT 7A Type A radioactive material (49CFR 178.350).

In order to demonstrate how vibration test are satisfactory for the transportation of the device to the site, we performed the following tests:

a) Basic Transportation Test (MIL-STD-810D, Method 514.2 Procedure 1) of the device without the source holder. See report in appendix G page G-9.

b) The source holder, with the glued sealed source, was sent within the shipping container to us (ELGEMS) by the source manufacturer (DuPont Pharmaceuticals) on a type A package. See test report Radiation Leakage from the Transmission Source Shipping Container in appendix F page F-14.

c) Assembly the source holder (b) into the device after the Basic Transportation test (a) and measure the device radiation leakage. See test report: Effect Of Basic Transportation (vibration) on Transmission Line Source Radiation Leakage on a device that have being performed a Basic Transportation Test, appendix G, page G-8.

Radiation Leak Test

see Appendix F, Radiation Measurements

ATCNRCAPPG.DOC G-2

EL OEMSTest Report test No. 453-3201-0002

Subject: MG ATC Rod shutter

Division: R&D Product: MG ATC Option

Contents

1. TEST PURPOSE ..................................................

2. TEST PLAN & RESULTS .................................

3. RESULTS ANALYSIS AND CONCLUSIONS.

Appendices

•,• Test Equipment

Camera MG CSE Camera with ATC Option proto #2

See additional Test Equipment List

ATC NRCAPPG.DOC

MG ATC

Approved by Sergio Steinfeld Performed by Alon Hillel

Position System Engineer Position Electronic Engineer

Date 12/98 Date 12/98

Signature lot Signature If

Page

..... .G-5

dllym

..................................................... i............

......................................................... i.......

.......................................................................... %J- F

G-3

EL OEMS MG ATC

Test Purpose The purpose of the test was to check the circuitry design of the shutter mechanism ( power failure self-fail ).

Power Failure

The shutter mechanism is normally closed. It is equipped with a spring solenoid which remains closed when the source is not in use or when the power is lost to the MG ATC Rod unit or when detecting potential failures. Therefore, at power failure the shutter is by default closed

The source shutter mechanism is tested by sensing the position of two slotted optical switches mechanical attached to the Tungsten rod shutter which reports whether the shutter is open or close. A yellow Led is electrical connected to the slotted optical switch which changes status according to

QJ the Tungsten rod position.

Reliability

The shutter is tested for approximately 2500 openings without failure , the equivalent of one year of use. Every year the Gd-153 source is exchanged and the device is inspected. The criteria is that there be no fails within these 2500 tests. This test was performed on the VTransACT Rod unit Elgems

p/n 473-3102-0207 who's shutter infrastructure is mechanically & electrical similar to the ATC Rod unit Elgems p/n 473-3201-1205. See Appendix G on the NRC file - report 475-3685-0002

ATCNRCAPPG.DOC G-4

EL OEMS MG ATC

Test Description Results pass fail Open/Close test ..... Enter the system as Service Mode and type CD 10. Then type APIMATE to enter into diagnostic and test ATC tool.

Type

Set output state 00010000

Verify that the shutter was opened, The shutter Lever position the mechanical Lever change is on its OPEN ("I") position to OPEN ("I") position and position. The Yellow Led the Yellow Led is ON. was turn ON.

Type


Verify that the shutter was closed, the mechanical Lever change position to The shutter Lever changes CLOSE ("1") position and the Yellow to CLOSE ("0") position. Led is OFF. The yellow led is OFF. Power off fail- safe Enter the system as Service Mode and type CD 10. Then type APIMATE to enter into diagnostic and test ATC tool.

Type


Verify that the shutter was opened, The shutter Lever position 3 the mechanical Lever change is on its OPEN ("I") position to OPEN ("1") position and position. The Yellow Led the Yellow Led is ON. was turn ON.

Power Off the Gantry.

Verify that the shutter was closed, the T mechanical Lever change position to The shutter Lever changes CLOSE ("I") position and the Yellow to CLOSE (l0") position. is OFF. The yellow led is OFF.

ATCNRCAPPG.DOC G-5

EL EMS MG ATC.....] Power off fail-safe :.I:-,,,, '"I ,

Shutter D~osition sensors testEnter the system as Service Mode and type CD 10. Then type APIMATE to enter into diagnostic and test ATC tool.

Type

Get input stage


(active low) 4 1 Bit 4 -shutter close

(active low) -4 0

Type


Verify that the shutter was opened, the mechanical Lever change position to OPEN ("I") position and the Yellow Led is ON. Tvye

Enter the system as Service Mode and type CD 10. Then type APIMATE to enter into diagnostic and test ATC tool.

Type


Verify that the shutter was opened, the mechanical Lever change position to OPEN ("I") position and the Yellow Led is ON.

Disconnect Power connector of the shutter control power cable 475-3102-02.

Verify that the shutter was closed, the mechanical Lever change position to CLOSE ("I") position and the Yellow is OFF.

Bit 3- shutter fully open . (active low) -- 1

Bit 4 -shutter close (active low) -- 0

The shutter Lever position is on its OPEN ("I") position. The Yellow Led was tum ON.

ATCNRCAPPG.DOC

J

.11

V/

V

G-6

The shutter Lever position is on its OPEN (S1") position. The Yellow Led was turn ON.

The shutter Lever changes to CLOSE ("O") position. The yellow led is OFF.

i

EL OEMS MG ATC

Get input.stage


(active low) -- 0 Bit 4 -shutter close

(active low) -) 1

Type


Verify that the shutter was closed, the mechanical Lever change position to CLOSE ("I") position and the Yellow Led is OFF. Type

Get input stage


(active low) -) 1 Bit 4 -shutter close

(active low) -- 0

Bit 3- shutter fully open (active low) -- 0


The shutter Lever changes to CLOSE ("0") position. The yellow led is OFF.

Bit 3- shutter fully open (active low) -- 1


Results Analysis and Conclusions

The results analysis concludes that the shutter circuit responds to the planned criteria. The tests shows and verifies as well, the power fail -safe mechanism .

ATCNRCAPPG.DOC

3

J

N)

y

G-7

ELscint General Electric Medical Systems ELGEMS Ltd. a P.O. Box 170 e Tirat Hacarmel 30200 ISRAEL. TEL: 9724-972-44563660. FAX: 972-4-8577662

Dr. Leonid Tsukerman, PHONE: 9724-8563659, EMAIL: [email protected]

MG AC Project Effect of Basic Transportation (vibration) on Transmission

Line Source Radiation Leakage

REPORT

Prepared and approved by Dr. Leonid Tsukerman, Senior Physicist, Radiation Safety Officer Wednesday 23 December 1998

The Basic Transportation (vibration) Test of the 45OmCi Gd-153 transmission line source was performed on Dec 2, 1998. The transmission source equipped with source housing (p/n S8429, slot S8429P003) and was glued into the source holder at DuPont and shipped within shipping container.

Test Method:

All the radiation measurements were performed using BICRON Micro SievertTm meter (Rate range - l gR/hh...200mR/h; Energy lower limit - 17keV). The leakage meter was calibrated by BICRON on Jul 1998. Next calibration due July 1999.

The measurements were performed with closed shutter at contact handling to source holder. The radiation leakage were measured twice: before and after the Basic Transportation (vibration) Test performed (see Appendix, pages G9- G14). As a weaker(decayed) source is used, the results are corrected to apply for a 450 mCi nominal source activity.

Test Results:

Side of the source holder Measured and decay corrected exposure rate in iR/h

Before Vibration Test After Vibration Test Lateral sidel 15±2 14±2 Lateral side2 12±2 15±2 Upper side 11±2 10±2 Lower side 12±2 13±2 Front end 39±3 41±3 Rear end 41±3 42+3 Background(without source) 5±2 6±2

Conclusion:

There is no significant effect of the Basic Transportation (vibration) on transmission line source radiation leakage.

6-8

Environmental Laboratory

Test Report26-Nov-98

1. CUSTOMER

NAME: COMPANY: ELGEMS Ltd.

We hereby confirm that the following system was subjected to testing on 25-Nov-98.

2. SYSTEM DETAILS

SYSTEM NAME: ATC ROD SERIAL No: TOTAL No. OF SYSTEMS: I

3. TEST PERFORMED

NAME: TEST TYPE: RESULTS REQUIRED:

Basic Transportation (Vibration) Development Acceptance visual + Functional check after the test.

4. TEST SPECIFICATION

REF. STANDARD:

DESCRIPTION:

(MIL-STD-810DMethod 514.2 Procedure 1.

One hr of vibration on each axis (vertical,transverse and longitudinal) sum of 3 hr. (see plot)

5. TEST RESULTS

6-9

.I L Environmental Laboratory P.O.B. 539 , Haifa, Israel

Tel: 972-4-8316717 Fax: 972-4-8316734

TEST OPERATOR: TEST FACILITY:

EXCEPTION:

SYSTEM CHECK:

ENCLOSED RESULTS:

M.gavrk A. Shaker mfg Unholtz Dickie, model TA 1000 B. Vibration controler nifg. Gen Rad modle 2503 None

Functional check after test.

Vibration- chart

COMMENTS/RECOMMENDATIONS:See System check..

CUSTOMER REPRESENT: no

6. LAB APPROVAL

WRITTEN Signature Date CHECKED O.HERCKO Signature a "a -te 26-11-98 APPROVE M.SHAKET Signature . -"a.te 26-11-98

W. . U .ORW............ I I US

6-10

Environmental Laboratory P.O.B. 539 , Haifa, Israel Tel: 9724-8316717 Fax: 972-4"316734

I

TEST SETUP ID: HGBOXUER JgLOJ MG PC BOX 131

Hz

TEST RUN NAME: RUN1416

REF RIIS: 1ý04 AUTO:01:00:00 STATUS: Finiished CON RIIS: 1.03 TOTL:01:00:27 LEVEL : 0.08dB CHAN SEQ:1

6-41

TEST SETUP ID: MGBOXLON

.to.t MG-AC Box

Hz

TEST RUN NAME: RUN1380 23/11/98

13:15:46

D ISPLAY

IC-CON 2-CHAN2 D -DRIVE H-DR/CT -2-2/CT

DOF= 120

LNS= 500

RES=5.0 L Il=3. G UAR BIJ

97.5 Hz ?-HELP

REF RrlS: 0.73 AUTD:01:00:00 STATUS: Fin~ished CON RIIS: 0.76 TOTL:0i:00:27 LEVEL : 0.0dlB CHAN SEQ:1

6_42

TEST SETUP ID: MGBOXLON

10-1 MG AC BOX

10-2

Hz

TEST RUN NAME: RUN138G 23/11/98 19: 16:12

DISPLAY

C -CON 2-CHAN2 D-DRIVE H-DR/CT -2 -2/CT

DOF= 120 LNS= 500

RES=5.00

JAR B14

07.5 Hz ?-HELP

0.73 AUTO:0l:00:00 STATUS: FinishedA 0.~75 TOTL:01:00:28 LEVEL : O.OdB CHAN SEQ:1

REF RIIS: CON RIIS:

/): ELscint General Electric Medical Systems ELI ELGEMS Ltd. e P.O. Box 170 a Tirat Hacarmel 30200 ISRAEL. TEL: 972-4-972-4-563660. FAX: 972-44577662

Dr. Leonid Tsukerman, PHONE: 972-4-8563659, EMIAIL: [email protected]

MG AC Project

Transmission Rod Unit Drop Test.

REPORT

Wednesday 16 December 1998

The Drop Test of the transmission rod unit contained 450 mCi of the Gd-153 transmission line source was performed on November 30, 1998. The source itself as well as transmission rod unit was examined visually. Also, radiation survey and leak measurements were performed to assure the integrity of the source and source housing.

Drop test:

Method: The drop test of the prototype was implemented in accordance with ANSI N542-1977, class 2 of drop test specification. The transmission rod unit was dropped so all of the six surfaces were impacted once. The test was performed as indicated per Table 1 (10 times to a steel surface from height of 1.5 m) of the standard.

Results: The source itself as well as the rod unit was examined visually and the source integrity was checked. No damage of the source and rod unit assembly including lead shielding, which could affect on radiation shielding was observed. The source itself was not mechanically affected. No bends and fissures or even position shifts were observed.

Radiation Survey:

Method: The radiation measurements were performed using BICRON Micro SievertTP meter (Rate range - 1I pR/h...200mR/h; Energy lower limit - 17keV). The meter was calibrated by BICRON on Jul 1998. Next calibration due July 1999. The measurements were performed twice: before and after drop test. As a weaker (decayed) source is used, the results are corrected to apply for a 450 mCi nominal source activity.

Results: The results of the exposure rate measurements and decay corrected values to apply for the 450 mCi source are represented in the table below:

6-1S

Tested side of the source Before Drop After Drop holder

Measured Corrected Measured Corrected value,mR/h for 450mCi value, mR/h for 45OmCi

I value, mR/h value, Lateral sidel 0.015±0.001 0.017±0.001 0.015±0.001 0.017±0.001

Lateral side2 0.015±0.001 0.017±0.001 0.015±0.001 0.017±0.001

Upper side 0.010±0.001 0.013±0.001 0.010±0.001 0.013±0.001

Lower side 0.010±0.001 0.013±0.001 0.010±0.001 0.013±0.001

Front end 0.030±0.001 0.040±0.001 0.029±0.001 0.038±0.001

Rear end 0.035±0.001 0.046±0.001 0.035±0.001 0.046±0.001

Background 0.005±0.001 0.005±0.001 0.005±0.001 0.005±0.00o1

Leak (wipe) Test:

Method: The leak (wipe) test was implemented according to section A2.1.2 of ANSI N542-1977 standard. We wiped all the external surfaces of the source and source holder with a piece of filter paper. The activity of filter paper was measured using MG gamma-camera according to the following protocol:

1. The camera detector was shielded with LEGP collimator.

2. The background was measured using STATIC acquisition performed with the following parameters:

ISOTOPE: ENERGY WINDOW: PRESET TIME:

Gd153 ±30% 1000 sec

3. The wiping material was placed on the detector surface and shielded by the collimator.

4. The activity of the wiping material was measured using the same STATIC acquisition as for the background measurements.

All the measurements were repeated 3 times.

The equivalence between the measured count rate and wiping material activity is estimated according to the following:

1. The camera detector efficiency is about 100% for 100 keV energy peak.

2. The lnCi radioactive source will produce the gamma-flux with count rate of 37 Count/s through full 2n solid angle.

3. The activity measurement method has geometrical factor of 0.5.

6-46

Therefore, the 20 Count/s is approximately equivalent to the 1 nCi of activity.

Results: The results of the background and wiping material count rate measurements and calculated activity values are represented in table below:

Measured Measured Activity counts count rate [nCi]

[Count/s] Background 11934±104 11.9±0.1 Wiping material 12020±107 12.0±0.1 0.60±0.005

The obtained results exhibit that the wiping material count rate does not exceed the background rate. Therefore, the maximal possible activity of the wiping material does not exceed 0.6 nCi. It was concluded that the source housing and source holder have no radioactive leak more than 0.6 nCi and considered to be leak free.

Conclusion:

The source and transmission rod unit passed the drop test and demonstrated the source and shielding integrity. The radiation survey and leak tests were passed before and after the drop test was performed.

Dr. Leonid Tsukerman, Radiation Safety Officer.

j

EL OEMS MG ATC

MG ATC Rod Unit

Appendix H Line Source Packaging Information

/ X

ATC NRCAPPH.DOC H-1

EL 6EMS

Contents

Packaging information privided by DuPont

Assembling Drawing of Source Container (Zvill) Assy 18- 119170000

Engineering Drawings of Pipe ( Zvill ) :

Rod Zvill Cover Inside Rod Zvill Large Tube Rod Zvill Small Tube Rod Zvill Cover Outer Rod Zvill Cover Outside Rod Zvill Buhna Rod Zvill Bush Rod Zvil Cover Inside Rod Zvill Ring Rod Zvill Lead Inside Rod Zvill Lead Outer Rod Zvill Lead Inside Tube Lead

Draw. 119040101 Draw. 119040103 Draw. 119040104 Draw. 119040105 Draw. 119040106 Draw. 119040107 Draw. 119040108 Draw. 119040109 Draw. 119040110 Draw. 119040112 Draw. 119040113 Draw. 119040114 Draw. 56131029409

ATC NRCAPPH.DOC

MG ATC

Page

H3

H4

H5 H6 H7 H8 H9 H10 H11 H12 H13 H14 H15 H16 H17

H-2

Author: "RONALD C. BROWN 671-8000" <[email protected]> at intelge Date: 28/01/98 17:41 Priority: Normal TO: Sergio Steinfeld at ELGEMS1 CC: Dany Eliav at ELGEMS1, "JOHN E. SUMARES" <[email protected]> at INTELGE Subject: Re: Gd-153 Source holder

Sergio, Thank you for your response. Your holder will require us to certify a

new box, but that is no problem aside from a time issue. The eventual package will be as follows:

Packaging design: The shipping container will be designed to accomodate two NES8429 Gd-153

line source each of which is contained in a source holder and shield. Each line

source consists of solid Gd-153 encapsulated inside a hermetically sealed

stainless steel capsule. Each source contains 450 mCi of radioactivity and

together they do not exceed Type A quantity for shipment of radioactive materials. Each line source, source holder and shield weight is -11 pounds.

Package Description: The exterior packaging is a corrugated (single wall, 200 pound test)

cardboard carton box (29 inches long x 9 in wide x 6 in high) which is sealed with 3 in wide tape. The interior packaging is an ehtafoam insert (1 in thick)

having a cavity which contains two source holders wrapped with 'kimpack' packing

%_ aterial. The primary packaging and shielding is a lead-lined source holder and shield.

Packaging Certification: Certification of the NES8429 Gd-153 line source and source holder and

shield shipping box will be in compliance with U.S. Department of Transportation packaging specifications for USA DOT 7A Type A radioactive material (49CFR 178.350). Authorized gross weight for this shipping container is 25 pounds. Authorized contents are encapsulated line sources (normal form) containing up to

Type A quantities of radioactive material and are installed in a source holder/shield. Maximum allowable radiation level is 200 mr/hr at the external

surface and transport index of 10.

We hope this information will suffice, but please feel welcome to

contact us if we may be of further help.

Ron Brown (DuPont Merck)

H-3

i ohn I fmw 1A' I I j

PART NUMBER/ QUANTITY FOR T NAME DIMENTIONS PROJECT

ROO ZVILL ROD 119040108 1

INING RING 6.0 2

ROO ZVIL NUT 119040111 1

T HEAD CAP SCREW UNC x4"40 2 1/2"

VILL BUHNA 119040107 1

WVILL LEAD INSIDE 119040112 1

ZVILL COVER OUTER 119040105 1 ZVILL COVER JUSTMENT

OUTER 119040106 1

T HEAD CAP SCREW 1/NC x -32 _____________ 1/2' 2

UNC a 4-40 - SUNK HEAD 3/8" 2

ZVILL RING 119040110 1

ZVILL COVER OUTER 119040113 1

ZVILL LEAD INSIDE 119040114 1

ZVILL COVER INSIDE 119040101 1

ZVILL COVER JUSThENT INSIDE 119040109 1

'ILL LEAD (TV&-L:e.4J) 561-31-2-11f 1

ZVILL SMALL TUBE 119040104 1

ZVILL LARGE TUBE 119040103 1

_ FINAL TREATMENT I IATL OTY

tent. Design

now= NX a m. Mz. lm"v I

man.s

Dn Lid. m 0=

IATI SQIG FD41SH

-&EA2 1:2 A , 21 O

• al m II - -m wm wl•tplm~

m""'1 VARICAM ELS tag uklavvec

f:VJPQtLSCINTr*=\ASST1S

PMRT WE~

ASSY18 OIWtGW4O

0 NO;

+4

I

).

I I I I 3

i

• •

Imt mm

I

I.S

oinal Is in. ii arhive deoartment

15. 12. 1997

I AY me.,..�-... . nr.nt.n 3

bIDEA I'ladhifte Devlote~n Design

8, Product r. LI.

WAN PAN

"- 10. a-mv,

-aw . *jflxg

* � n -

AIAAA4 I I

-V-T*ANSACT

ROO ZYILL COVER JUSTMENT INSIDE

-H04M7

C Cd i

e-2 wcl.~ 10.101 A170

.3-

L

I I

I+

AIMINF

E I', Gr Pw M.

IN&

0110"m

A 21-4- 2:11 1 om on

--- ---- -L

.4

0 38.0 REF-

0ie.

-- - - -- - - - - - - - - - - - - - 1--pi -12.0 REF-

15.0 ') CMf~

£. ,J1

COPY: The original Is In tii, *archive deoa'4 '-isnt

15. 12. 1997

'EL GEMS I ROUND TUBE 8015

I I1�AI IM�AII�NT I FINAl TDC'AT�.CUT

I BLACK( Amflfl79

bIDEA Machine Devetopmenti Design

&Production Lid.

DATE SIGN

0WEM!N AK SlIn~ -a.II

go.u1 Wtv tom.2

M34.0 Xl .01 2 SIDES

T T3. 0 MM ) '~ MATERIAL OTT

AL 6061jj 'PM~t T K"V-TRANSACT FILE m~MIWPJ"

M~wXL w tas ROD ZV ILL LARGE

ScX11

I.U- I1� - - - ,aw.u - - U �s*U� W�W w.w* �We fl �W. .. A*

'I?. UN.

I I

Ik I~f

I I

GESIOI

�WI4

o�cx Si"-LOMOI

I"m Imm

0 3

APNM omo

I I

I HEA1 IRFATWNT I CIMAI TOCAT"Cur

*�i. LII. Ktc�:pym IS'1! INNS

II �I I.j

*16.0 REF 'OTHRU

I-J-i

COPY: The Origi-nal It lntiharch!".l deoartme~nLJ

15. 12. 1997

0 19. 0 REF

ROUND TUBE A031 ( T=1.5 MMt )

IHEAT TREATMENT IFINAL TREATM~ENT MhIATERIALOT

II 1BLACK ANODIaZE.... AL6061 -W 1

bIDEA Machine Development. Design

& Production Lid.

cEslcN BOR IS /ni CIP BORIS f6/!0/91 CHEU SHIOto ______

7-1- WILs.. I I

WLESS U"I(Ust VICIFICS

811EIISI0 AR In M.

POCK ALLUPWlREMSO.SXqg. ROD ZYILL SMAL

N8 (NO - OIf JO

IS

n f ISV-TRANSACT

-6

F

r 0

. 0 .0

INEV. LM. KSMIFTION

.n a

1 .1 _j

I We I VM

.I .

- -- -- -- -- -- -- -- -- -. .. .. . ------

DATE S [CANot

EIMIFT1" ~DAM oprm

-archiv e d Ortgingit~

15. 1Z 1997

03.5+0.2 2 PL F*70. I Al 01

SECTION A-A

14-g

HEAT TREATMENT F INAL TREATMENT : 4TRA Y

I ALODJ I NE1__-L606

b IDEA Machine DeveLopment. Design

& Product ion Ltd.

A~sIQl

TIy 4DATE

BORIS blmum

SI-IlOMO JSHLAMfl .L �- - � I ________ .L J.

slot

vaJUstai Immc wm

FIN- SI4W inNW A SN .E n so I I I

N8 (NO

I~77.Wfoh Gm- w ft psso - h "aWfts aI U*ý fli. -. v mq P..

mom wmV-TRANSACTFIlu "fmDURII

�n �onn�, -flAAPART KW!

ROD ZVILL OUTER OIIMESION

COVER

r77GO1-19040105 ~:

C REV. L41

F

I I

B

sm nmnsm nmn

A

archive department

15. 12i997\

'ELGIMHEAT TREATMENT FINHAL TREATMENTI T

I O I NE .AL6061j

b IDEA Machine Devetopment. Design

& Production Ltd.

DESIGN BORIS M001

OR"E BORIS 7/12/9

OMc SHIOMO I __ I __ - F

01WIENS AK In Mm.

M. 7L'Ss ±0. 2 ANOM1 6q

FINISH

N8 (NO-)

31CAE 2:1 1 SHET

M"weV-TRANSACT FIL MUVEflNf

PART RNAI

ROO ZVILL COVER JUSTMENT OUTER DIMENSION

- __ __ i J I _ _ _ _ _ __ _ _ _ _B

C7

ZQ

NAM~ DATE S IGN

H-43

�I4I AMA

K=t"M IMIC I om

I:

ona"a " am mmo 0 - ý - ou- 9-W 0 " "Wfthm

I-Sffc~l~fm IUu 9W~

I I

#4-40 UNC J0

66.0

62.5

-0 6.0O-OI

39.0

-24.

10.0

4. -.-5.0

-0 10.0-0.1-0 15.5-0-1

COPY: Th. orgiaii h.. archiV9 departmeint

IZ1997

'ELGIM -m 10.0 X1 .0

lo0.1 AI

HEAT TREATMENT FINAL TREATINT MTRIA

BRS I-

bIDEA Machine DeveLopment, Design

& Product on Ltd.

"MElvT

T

DATE

DESIGI I BORIS h.7/08/n 01 13BRIS h3L/12/91 fo~ jSHLOIIO -E IA

DDlJwoI5 AK IN W.

m-v"' ~s±0.2

PftOLL MW. 9M 1941 .X4S-

FINISH4

N8 (NO -1

31 cAL: 2 : 1-. ... L

9, I~ *~ maU S~,~m - ~ P - - -- -V -

rag .*lactim

PMRT HAMl

ROD ZVILL BUHNA

i H

1 0 1A

Ill. * I LIT. Iif

"Weef Pun V-TRANSACT

CAR om

SIGN

APPM 'SHLOMO

00t. 0St. 01"TO UIm4lm1 9A orna

C

4.0

SECTION A-A SCALE 4: 1

+0.10

DETAIL A SCALE 2:1

COPY: The original Is In 'h archive dfio2rtmert 4

115. z10911

GLM jtF

HEAT TREATM'ENT -FINAL TREATMfNT =MARALI CITT Y

I ALOpINE A66

bIDEA tMchine Development. Design

& production Ltd.

04.135 U4wMs9 51Mw11

DIMJIIW Alf IN M.

m.f-:t0. 2 DAWM2 10*15

Kmg &L ow Ems! O.5X451- . - Y - - 4.

DATE SIGN

oEsiGN BORIS J12/08/97

mum 3RlS J03/12/91 -jC - +L- MO-

SI-LO110

FINISHN8 (ND-)

31 SCAE x 1 SHET CJj

wfo R-A,ft w * abp " - an ow*-"* Os.M V.4 k

17.4

6.0

10.0 ±D-.1

I

A

5.70 -0.10 2PL

tyf4 4

"' ` V-TRANSACT

PATNA ELS\ROD\L-067

ROD ZVILL BUSH

0'r'No' 1190401013 A. I

I

I

+ 9-4Z

'.4

... --- c

I

C

0

0 £1.01-7

F*T o.61**

0 3.3+0.2

2PL * .0

2PL

COPY: The original is In IN~ archiv'i denoirtmont

15. 12. 1997

EL r, FMSvyHEAT TREATMENT IFINAL TREATMENT MAERAL OT Y

I ALOO I NE A66

bIDEA Maechine Oevtopment, Design

& Product ion Ltd.-� I - _

0-1?s uiw0"mr~S;Vw f pcIF I

ON-~t. Alt$ ±0m.2

"W" M m ll V-TRANSACT F ILI KIIEMIot

AWEMg.fl ISa PART NAME

EIW.L~ .545ROD ZVILL RING FINISHN

(O

SCL: 2:1 __ _ __ _ __ _ A 3 SHELET ONO 0110A, IRA' 1

H 3 off " q~ ~U UU U

(.N

.4

WES 10

DRAW

OlWcK97

NAPE

BORIS BORI11S SHLOMO QIJI lný

APPM

I

I

LINSC

.1

.COPY: The original Is In the arhve department

15. 12 1997

'EL GrEMS

-HEAT TREATMENT FINAL TREATMENT :ýAEILIOTY

bIDEA Ma~chlInePDevelopment Des ign

& Production Lid.T

m.I.*±02

~We ALL Ow~ EMS0.54

FINISNf

M SI6 BORIS 6Inlli O RA W . B O R I S 1 1 Zl2 iL" I 1- A OOCK SHLOIIO I_ _I

N8 (NO

SCALES 2:

"Mal Mu V-TRANSACT

FMA MOMf"U %FI rDflflU -onj

PMTHMIE~

ROD ZVILL LEAD INSIDE

offealSopf

"WS119040112 AyIorNMOM GnMQM " Mv MMOM - ý Ww U 0mu W -00 "" 0- v "

gwris Kgi amUW W

F

0 4.0 2 PL

0 11.0-l

OATE SIGN

�tn � ai SMUN-10 i

I

*. I.-------- u-

0 50. 0 :0:30 '3

COýPY: The original Is in the archive department

15. 12. 1997

HEAT TREATMENT I FINAL TREATHENT

bIDEA Miachine Oevetopment, Design

& Production Ltd.

BOR IS

CAl

DNUMIES gp 3M

10v ALL MWA fol 8.SX45-

SIGN IFINISH

-4 N48 (NO0-)

"- " 0 - - . ý ~- m- ý i 44 nS =U - r - -%-EW w a

HATER IA. CITY L EAD1

"rawx"V-TRANSACT

PART HM~

ROD ZVILL LEAD OUTER

11904113J

C Ia I

I I

I I I I

1 5. -.

1�

(7'

I.

"19 PPM

0 40.0+0.2

0 30.0 .0.2

I. -

�'7)7A

ýCR

S. 0 #0.2 j

I

__LAPPRO -LSHLOMO I I SHEET an I

F

7 r/-; 7

�I. LII. ms�I,,asis SAIl i�

C

-450 X 5.0 4PL

,0 5.0 +0.2 2PL

1+10.21 A B

COPY: The original Is In the archive department

15 12. 1997

P fry.FMS.HEAT TREATMENT F1 tAL TREATMENTMA AL . o T

I_ _ _ LEAD5A M I

b) IDEA Nichine Devetopment, Design

& Production Ltd.I-,

Koff DATE

DEIG BORIS 1,2/o0/97 MM BORIS 11-/11/oe-SHL0~iO I_

APfRO I SHLOnO

SIGN

WA4.1S SlO'lI~t(lll litCllfrl @REIIqI~P hat IN -.

m. ws.', -0.2

5NNW &a. Ems O.S$45

""w' " V-TRANSACT

-' "'tLS\ROO\L-09 i PMT JA1 ROD ZVIL LEAD

F,.,NIS D N8 (NO- ) INSIDE _._, ___1"2I•?- DMENSION

[CLEr 2 OGN _ 10 0 1

• 044KN m fv "inaws w ~ avwý 0.0fow ~ uwm 0 v

C:P I%

F

I

S

i = I

I

I I I ARM SHLOM10

I

600t1

NAME DAT di~ i4UI~t UWPS"

H .OTU. LEAD

NB.1

561-3 -9. 09N.

X.

EL OEMS MG-ATC

MG ATC Rod Unit

Appendix I Quality Assurance Program, Assembly

And QC Test Instructions

ATCNRCAPPI.DOC 1-1

ELOEMS

Contents

Quality Assurance Program Assembly & QC Instructions

MG-ATC

Page

13-14 15-122

ATCNRCAPPI.DOC 1-2

EL OEMS MG-ATC

ELGEMS QUALITY PROCEDURES - OVERVIEW

Procedures And Processes

Product processes and procedures are developed in accordance with FDA's Good Manufacturing Practices ( GMP ), ISO 9001 (quality system standard) and EN46001 ( quality system standard for medical devices). ELGEMS is ISO 9001 certified.

Design

Products are designed in accordance with Elgems Phase Review Discipline ( PRD), which is a product life cycle process. The PRD describes the steps and responsibilities required from initial product concept to end-of-product life. For product design and development, it describes design specifications, output, verifications, validation, transfer and changes. It also includes processes for regulatory compliance, safety, quality, marketing requirements and user instructions. New products and major modifications to existing products are developed in accordance with the PRD. Minor changes to products are completed via the Engineering Change Order ( ECO ) process.

Manufacturing

All products are manufactured and tested in accordance with FDA's Good Manufacturing Practices ( GMP ), ISO 9001 (quality system standard ) and EN46001 ( quality system standard for medical devices . This includes:

1) Establishment of a Device Master Record including applicable drawings, list of parts and materials , assembly/test documents and shipping requirements.

2) Device History File containing assembly, test and inspection documentation per the Device Master Record for each device manufactured.

3) Defect tracking 4) Training of personnel. 5) Disposition of non-conforming material. 6) Handling , inspection and stocking of incoming and in-process parts,

materials and devices.

Purchasing

Selection of suppliers (vendors ) and purchasing of materials is conducted through the Sourcing Department per appropriate processes and procedures that comply with ISO 9001. Product, part and material specifications are defined by engineering.

User and Service Instructions

Operator and Service Manuals are written by Technical Publications staff, and reviewed by Engineering, Applications, Service and Legal Operations as appropriate. These manuals are developed per the PRD according to specific format guides, They contain

ATCNRCAPPI.DOC 1-3

EL OEMS MG-ATC

the instructions required to safely and effectively use and service the device, including applicable safety warnings and regulatory statements.

Device Training

Training on the safe, effective use of the device is conducted by the Applications staff

upon initial installation of the device and upon request of the user.

Service

Each device is supplied with a service manual that includes appropriate warnings for system and radiation safety. Product quality, safety or regulatory issues discovered during installation and servicing are forwarded to ELGEMS by our customers complaint handling systems. ( Service records are maintained on all service visits by our customers GE and Elscint )

Complaints

Product quality, safety or regulatory complaints are forwarded to the ELGEMS complaint handling process where the issues are reviewed, investigated and resolved ( as appropriate ) per documented processes and procedures, in accordance with FDA requirements.

Product Changes

All changes to existing product are routed through the Engineering Change Order ( ECO) process and approved by appropriate staff. Matters regarding safety and regulatory are reviewed and approved by members of the ECO committee. Validation is required prior to issuance of a change. The ECO process updates the Device Maser Record as appropriate.

Quality Systems Audits

The quality system of ELGEMS is audited periodically both internally and externally. Results of audits and resolution are documented and archived. These audits include ( not an all-inclusive) review of processes, procedures and documentation for:

1) Design ( including safety and regulatory requirements) 2) Manufacturing. 3) Sourcing 4) Material acceptance. 5) Complaint handling. 6) Product changes. 7) Non-conforming materials/devices. 8) Quality policy, quality manual, management reviews. 9) Personnel training (including radiation safety, as appropriate for the

business)

ATCNRCAPPI.DOC 1-4

ELOEMS Ld.

MG ATC Rod Assembly Instructions

ASM000415

ECO REV DATE NAME APPR. DESCRIPTION

E9634031 0 23/3/99 SERGIO Beach NEW DOCUMENT

~ ~'NAME DATE SI

EDITED STEINFELD 23/3/99

CHECKED AGHION 2353/99

APPROVED BEACH 23/3/99

fl CONTENTS PROPERTY OF ELGEMS LTD. NO UNAUTHORIZED USE PERMITTED.

DOCUMENT NAME: MG ATC Rod assembly Instructions I D/N: TST000047 VER: 01

PRINTING DATE: File Name: C: 23/03/99 PROCECTS\ATC\PRODUCTION\MG ATC ASSY.DOC

ELOEMS Ltd.

Contents

MG ATC Rod Assembly Procedure MG ATC Rod Assy (ASM000415) QC Tets Procedure for MG ATC Rod Unit

I-7/I-9 1-10/I-15 1-16/1-22

1. 2. 2.

DOCUMENT NAME: MG ATC Rod assembly Instructions -TD/N: TST000047 VER: 01

PRINTING DATE: File Name: C: 23/03/99 1 PROCECTS\ATC\PRODUCTION\MG ATO ASSY.DOC

MG ATC Rod Assembly Procedure

This procedure should be used in conjunction with drawing set ASM 000415

Tools and Equipment Required

1. Feeler Gauge Mytoyoyo 2. Torque meter 4 - 20 Nm 3. Torque meter.40 - 260 Nm 4. Pin insertion tool 5. Bearing insertion tool 6. Pin insertion tool M6

Environmental Requirements

The table below lists the environmental parameters required for rod assembly. The actual temperature and humidity should be entered in the last column.

Results

No Procedure Equipment Expected Obtained Name

1 Fit the left rod cover to the pin insertion tool Pin insertion The six pin and insert four of the six pin dowels (#5) into tool dowels are fitted the holes on each end of the cover. fush into the

holes on both ends of the cover.

2 Fit the 3 nut inserts (#6) into the holes on the M6 insertion Verify that the right front of the cover. Insure that the inserts tool inserts are fitted are flush with the front surface. ush

3 Insert the two remaining pin dowels Pin insertion Verify that the (#5) into the holes on the front of the cover, tool ins are fitted

fush

4 Remove the coverfrom the jig. Check visually

5 Fit the ATC collimator to the left rod cover Verify that the (sheet 2) using the 2 adaptor bushes (#3) lightly bushes are fitted coated with no 222 Loctite. Ensure that the ush bushes are fitted flush.

6 Secure the collimator to the cover using the two Torque meter Confirm that the (#4) shoulder screws torqued to 100 Ncm 40 - 260 Nm screws have been

correctly torqued

7 Fit the two long capture screws (#11 on sheet 3) Verify that the into the upper holes of the rod adj inner assembly is assembly (#7). Fit the two short capture screws correct (#12) into the lower holes

Required Measured

Parameters

Temperature 180C - 28 0C

Humidity 35%- 80%

K)

8 Fix the lead rodplate (#10) into the recessed Confirm hat the slot in the rod adj inner assembly (#7) using lead plates are epoxy adhesive.Emsure that the lead plate is fush with the fush with the outer surface. outer surface

9 Fix the lead plates (#8 & #9) to the rod adj inner Confirm hat the assembly (#7) using epoxy adhesive. Ensure that lead plates are the lead plates are tight against the inner ush with the surface, and do not protrude beyond the outer outer edges. edge.

10 Insert bearing (#17) into the rod adjust outer Bearing Confirm hat the assembly (#13) using the bearing insertion tool. insertion tool bearing is fitted The bearing should be lightly coated with Loctite flush

11 Fix the lead parts (#15, #16, & #17) to the inner Confirm hat the walls of the rod adjust outer assembly (#13) lead plates are using epoxy adhesive. Ensure that the lead flush with the plates do not protrude beyond the outer edges. outer edges

12 Fit the two opto-couplers to the metal bracket torque meter Confirm that the (#19) using the four screws (#20), washers 40 - 260 Nm screws have been (#21), and lock nuts (#22). Torque to 80 Nm correctly torqued

13 Fit the rod position indicator plate (#24) to the torque meter The pin is flush base of the inner rod clamp (#23) using screw 40 - 260 Nm with the outer no (#26). Do not tighten. Rotate the rod position surface indicator plate (#24) until the hole in the Confirm that the indicator plate lines up with the hole in the base screw has been of the inner rod clamp (#23). Insert pin (#25) correctly torqued until flush, and secure with Loctite. Torque screw (#26) to 80 Nm.

14 Insert pin (#29) into the inner rod clamp (#23) The pin is flush Ensure that the pin is flush and secure with with the outer Loctite. surface

15 Fit the Tungsten rod (#31) to the inner rod Feeler gauge Verify a gap of clamp (#23) using the rod clamp cover (#32) Torque meter 0.5 - 2.5 mm and fastening screw (#33). 4-20 Nm between the end Note: There should be a gap of 0.5 - 2.5 mm of the rod and the between the end of the rod and the base of the base of the inner inner rod clamp (#23). Torque the screw (#33) rod clamp (#23) to 5Nm, and secure with screw (#27) and bush (#28)

16 Secure the inner rod clamp (#23) to the solenoid Confirm that the (#18) using the three screws (#60), and washers screws have been (#30) to a torque of 100 Nm correctly torqued

17 Fit the outer rod clamp (#34) to the other end of Verify that the pin the Tungsten rod (#31), and insert pin (#29) into is flush. the side of the outer rod clamp (#34) Ensure that the pin is flush and secure with Loctite

18 Secure the Tungsten rod to the outer rod clamp Verify that the (#34) with the clamp (#32) and fastening screw assembly is (#36), but do not tighten. Fit setscrew (#27) and correct bush (#28) to the outer rod clamp (#34), but do not tighten.

19 Fit the outer rod cover (#37) to the solenoid Verify that the assembly (#18) using nuts (#40) and washers solenoidfastening (#39). Center the solenoid fastening shafts in shafts are in the the oval slots. Tighten the nuts lightly. center of the slots.

20 Fit the rod adj inner assembly (#7) to the outer Verify that the rod cover (#37) using the four screws (#38). assembly is Secure with Loctite 222. correct,

21 Insert the set screw (#41) into the hole on the Torque meter side of the cover. Adjust the clearance to 40- 260 Nm 20.8 ± 01 mm, and Secure with bushing (#28), and setscrew (#42). Torque nuts (#40) to 100 Nm, and secure with Loctite 222.

22 Adjust the length of the Tungsten rod (#31), by Dial type Verify that the moving the outer rod clamp (#34) along the Caliper Tungsten rod Tungsten rod until a length of 560 mm ±0.5mm length is 560 mm. is obtained

23 Tighten the fastening screw (#36) to a torque of Torque meter 4 - Confirm that the 5 Nm, and secure with setscrew (#27) and bush 20 Nm screws have been (#28) correctly torqued

24 Fasten the optocoupler assembly bracket (#19) Verify that the to the base of the rod adj inner assembly (#7) assembly is and secure with Loctite correct

25 Fit the left rod cover (#1) to the rod adj Torque meter Confirm that the assembly using screws (#11) and (#12) and 40 - 260 Nm screws hove been torque to 150 Nm correctly torqued

26 Secure the rod adjust outer assembly (#13) to Torque meter Confirm that the the left rod cover (#1) using screws (#43), 40 - 260 Nm screws have been torque to 150 Nm, and secure with Loctite 222. correctly torqued

27 Fasten the right rod cover (#46), to the left rod Torque meter Confirm that the cover (#1) using screws (#11), (#12) and (#43). 40 - 260 Nm screws have been Torque to 150 Nm, and secure with Loctite 222. correctly torqued

28 Adjust the setscrew (#58) in the rod adjust outer Dial t'pe assembly (#13), until a measurement of 18 mm caliper +0.1 is achieved. See section BB in drawing 6.

29 Fit thefilter (#45) to the left rod cover (#1)

30 Fasten connector (#18) to connector bracket Torque meter (#51) using the kit (#52) and lock-nuts (#53). 40 - 260 Nm Torque to 80 Nm

31 Secure the connector bracket (#51) to the rod Torque meter adj inner assembly (#7) using screws (#55). 40 - 260 Nm Torque to 80 Nm and secure with Loctite 222.

32 Insert pins (#59) into rod cover (#44). Secure with green Loctite and ensure that the pins are pushed to the bottom of the drilled holes.

33 Fit rod cover (#44) the rod adjust outer Torque meter assembly (#13) using screws (#43). Torque to 40 - 260 Nm 150 Nm.

34 Fasten the location screws (#49) and (#50)

35 Fit the locking device (#47) to the rod adjust outer assembly (#13), using the locker screw (#48). Ensure that the rod actuator screw (#35) is under locking device (#47)

Fit cover (#56) to the rod adj inner assembly 3 • (#7) using screws (#57), and secure with Loctite

222.

-SOLONOiý. INST-.AS

SEE PAGE 4

ASSEMBLY NAME:MC No :OPT000052 NAME: ROD ASSY DRAWING No: ASMO

Af 7

1.0 OI70~H~~O5~g47r I cR I I -0.19 1eo .00170iHSIJ35920JC SCR FLT 82 4x,116

i 1-o001701,MECO03922 ROD PLATE INSIDE 2.00170OI fSO800300a SCRW FL.T AIJ38

leo 2.001701HSOI109204C SCR PAN HEAD 4.,I1.,. led !2. 00170 10N310204C NUT LOCK 4

Io - 3071PO 272J210000o DTYPE KiT I¶Io .001701 MECOO350I ROD CON. BRACKET

1 .00 70 MEC0o0j844 Ro0 BOLT Pos. IN

S 71.D00 701 MECOOJ843 ROD BOLFT POS.

0 I I-.00701MECCOOJ92 LOCKER SCREW

_o ! 1. 00 701 MECO03997 LOCKER

I 1.0 L2j 0 5 1L RIGHT P00 MACH. 1_00701_ 0 l .IO0t7 o03ECOO.S..I. RifL TR

lea 0 1. 001701oMECOO3SOB RO0 COVER

1-- 1 6.001701HSO9349312C SCR SKT 6,3,4

ie 11.001704HS SMS9402C SCR SET xie8

1ea 1. 00 701 HS05339412F SCR SET NI 8x3r4

*ae 2.00170' HNOOI079OSC NUT HEX UNC 6

lea I 2.00i701HW0109JOO0 WSHR Lr 6

1 4.00170; NS09349208C SCR SKT i4jll2

0 I 1.001701 IJECOOJ9B16 RO0 COVER INSIDE

e00 1. 00 701HSO.93449408C SCR SKT rx o12

'0 1_.001701 MCCO04007 ROD SHUTER ACT SC.

1.00r701 MECOO3031 :RO0 CLAMP OUTER

1e .I .00 701NH09349406C SCR SKT 8r3/.8

jee I 2.00170, MECOOJ904 ROD CLAMP COY OUT ea1 ..001701TZIi0200001 pROD TUNGSTEN

go 1J.00701HWOOTO92001 WSHR FLT M3

I 1.001701 HPD23000212 PIN DOWEL 2,12

@ea J..001701MECO039-28 LOCKING GUSION 0 i2.0017O0NS0S34,403C SCRW SET 83..,16

1_ _. 001701HSO_93420_JORHEAD SKT4x3/I

be 2.00 701 HP023000212 PIN DOWEL 2,8

a, I 1. 0070 MECOO3gI9 ROD PLATE POSITI0o

1.e00 70' MECOO3917 ROD0 CLAMP INSIDE

60I4. 00101h1l1720030M NUT LOCK PLEX M13 *a cooly0vHWOOIOOOO3M WSHR FLTImi @a1I 4.00 701HS0040030 10 SCR HEAD SKT 1 £7 A

eo I 1.000701 MCO03921 PRoo SuPPORT INSIO

I I .00 .701CBLO.5J37 AT PRO0 CABLE

0 1.[00 17010B2OIO 1 BEAR.BALL 6xj3.3.

& 10 I 0.oo 0701ECOOJ9s ROD LEAD OUT UP *0 f 1.00 M70L AECOOj9 i s RO LEAD ADJ OUTE 60 1.0001

701 MCCO03990 ROD LEAD OUTSIDE

e0 [ 1.00 701[MCCOOSOO P0ROD COVER ADJ. OUT

00I 2.001701MECOOJ338 RODP BOLT INSIDE

100 2.001.0 MEC003839 R0O SOLT INSIDE

100 7-1.00170 MECOOJ952 RO0 LEAD PLATE

[t I 1.00170M1C003O923 R0O PL.LEAD FR. I,

600 .0070 MECOOJ987 RO0 LEAD PL . COV. I

I -100 701MECCO039O15 ROD COV. ADJ. IN.

0 3. 00 70 HNOOOIO060S NUT INSERT M608

00 8. 0070 FP023000410 PIN DOWEL 4,10

60 -2. 00701 HS10 10233M SHOULDER SCR £13

*a 2.00o70 MECO03.513 ADAPTER

00 7.00 70 1ECOOJ452, AC2 GATC COL.

"60 1.00 70"MECOO3S12 LEFT ROD MACH ,. or o..et 60. .C . .. WI.TS ..Ik y u 1.0.. .. .

IT C :...i* 1 CC.f S,,," MG MG ATC

.. ~ ~ i.: 2.ORODASSY

SSCR SKT NC 5.114

0230003,6 [PIN DOWEL 3J,6 sos3jj4to0 scR sr TN~r a.5,-

C

le _._00__ 1ooI7b

leo !

ROD ASSY

I. oolwo! HS

�LEFT.ROD ASSYI �OR ECO SEE PAGE 1

----- M

ASSEMBLY NAM1t:mG AC.:a: .0:2.0

N.AME: _OASSY 10 P~~

MG AT

HS .. .. ..

X3

;LEFT:ROD ASSY FOR ECO SEE PAGE I

)

I

(ii) (i')

lSV-63NN I 0V ---

30yd 33S 0033 b0.

I: I:

Ii

)

I

SOLONOID ASSY

FOR Eco SEE *ACE

OPTOCAPLERS ASSY

e-XA

ASSEM8LY AMEý-,,--AT No:OPT009052 NAME: ROD ASSY

IDRAWING No: Aftun-iý..A

VV NOII3~35

I

( )

I ODTP ASSYJ

rOR ECO SEE DAGEiSECT 098

9,

ME IF MG GATC

ASSEMBLY NAME:MG AT Pm Ic No:0PT000052 - . .=1.0:2.0 V0 ASSY NAME: ROD ASSY DRAWING No: ASM0004 S -~ 1T1r-7-T-ri ~r

)

ýCOVER P INF ASSYýI

EL 6 EMS MG-ATC

QC Test Procedure for ATC Rod Unit p/n ASM000415 mechanical assembly

Contents Equipment Needed Set-up installation Shutter test Motion Test

Equipment Needed

ATC Plate p/n 502-3201-3808 ATC Linear Base pin 502-3201-08 ATC Rod Holder pin 502-3201-10 ATC Rod pin ASM000415 Dual Head camera MG CSE with Acquisition Station GenieAcq. Allen set ( mm & inch)

Set-up installation

Power -on the Gantry and remain in H-shape mode (parallel heads) Install the ATC Base, Adapter & Linear Base Plates and the ATC Rod according to the following instructions referenced to drawing ATC Assembly:

1) Bring the gantry to H mode with a rotor angle of Odeg. Remove Detector cover of the upper head.

2) Assemble Part 1 Adapter plate ( draw. 502-3201-3808) on the main detectors support plate using two screws M=12 and three screws M=6.

3) Assemble Part 2 Linear Base plate ( draw. 502-3201-08 ) on part 1 using seven screws M=8.

4) Assemble Part 3 (ATC Rod pin ASM000415) to Part 2 with Part 4 - Rod Holder (draw. 502-3201-10) using three screws M=6.

Connect the following gantry cable to the ATC Base and ATC Rod units:

ATC Control cable p/n CBL000525 ATC Base cable p/n CBL000526 ATC Ring p/n CBL000528 ATC-API cable p/n CBLOO0530 ATC-IPS cable p/n CBLOO0531 ATC-limits cable p/n CBL000532/3/4 ATC Rod cable p/n CBL000537 ATC Led cable pin CBL000536 ATC-Acq. Station cable pin CBL000538

ATC NRCAPPI.DOC 1-16

EL EMS MG-ATC

Test Desc6ription I . Resul-ts [Pass, ___i

___Ope6nlCllse~tlst -__

ATCNRCAPPI.DOC 147

Verify that the shutter is closed, the mechanical Lever change position to CLOSE ("0Q) position and the Yellow Led is OFF.

Enter the system as Service Mode to directory c:/usr/service/io

Then type apimate input stage.prg

verify the resulting value : Hex-14 which represents the status of the opto device sensors Open/Close sensor -4 Close FullyOpen/not FullyOpen -- not F.O.

Then type apimate open.prg

Verify that the shutter was opened, the mechanical Lever change position to OPEN ("I") position and the Yellow Led is ON.

Then type apimate inpuLstage.prg

verify the resulting value: Hex-C which represents the status of the opto device sensors Open/Close sensor -) Open FullyOpen/not FullyOpen -- F.O.

Then type apimate close.prg

Verify that the shutter was closed, the mechanical Lever change position to CLOSE (uO") position and the Yellow Led is OFF.


verify the resulting value: Hex-14 which represents the status of the

The mechanical Lever change position to CLOSE ("0") position and the Yellow Led is OFF.

Resulting value: Hex-14

The mechanical Lever change position to OPEN ("I") position and the

Yellow Led is ON.

Resulting value: Hex-C



ELOEMS MG-ATCopto device sensors Open/Close sensor -4 Close FullyOpen/not FullyOpen -4 not F.O.

Powera offfail- safe -testi .. . .. _- _

Verify that the shutter is closed, the The mechanical Lever mechanical Lever change position to change position to CLOSE CLOSE ("0") position and the Yellow ("0") position and the Led is OFF. Yellow Led is OFF.

Enter the system as Service Mode to directory c:lusr/service/io

Then type apimate open.prg

Verify that the shutter was opened, The mechanical Lever the mechanical Lever change change position to OPEN position to OPEN ("I") position and ("I") position and the the Yellow Led is ON. Yellow Led is ON.

-- Power Off the Gantry.

Verify that the shutter was closed, the The mechanical Lever mechanical Lever change position to change position to CLOSE CLOSE ("0") position and the Yellow ("0") position and the is OFF. Yellow Led is OFF.

__W__ er offfall -safe -test 2Verify that the shutter is closed, the mechanical Lever change position to CLOSE ("O") position and the Yellow Led is OFF.

Enter the system as Service Mode to directory c:/usr/service/io


verify the resulting value: Hex-14 which represents the status of the opto device sensors Open/Close sensor -) Close FullyOpen/not FullyOpen -> not F.O.

Then type



ATCNRCAPPI.DOC 1-18

EL OEMS MG-ATCI apimate open.prg

Verify that the shutter was opened, the mechanical Lever change position to OPEN ("I') position and the Yellow Led is ON.


verify the resulting value : Hex-C which represents the status of the opto device sensors Open/Close sensor -4 Open FullyOpen/not FullyOpen -) F.O.

Disconnect Power connector of the shutter: ATC Control cable p/n CBL000525

Verify that the shutter was closed, the mechanical Lever change position to CLOSE ("0") position and the Yellow is OFF.

Then type apimate input~stage.prg

verify the resulting value : Hex-14 which represents the status of the opto device sensors Open/Close sensor -4 Close FullyOpen/not FullyOpen -4 not F.O.

Repeat test while disconnecting the cable ATC Rod cable pin CBL000537

The mechanical Lever change position to OPEN ("I") position and the Yellow Led is ON.

Resulting value: Hex-C

The mechanical Lever change position to CLOSE ("0") position and the Yellow is OFF.


6Rod'motion test•f. ___

Enter the system as Service Mode to directory c:Iusr/service/io


verify the resulting value : Hex-14 Resulting value: Hex-14 which represents the status of the limit switches

ATCNRCAPPI.DOC

V

1-19

EL OEMS MG-ATC

Inner limit switch -- not active Outer limit switch -- not active

Then type apimate movefwd.prg

The rod starts moving outside the rotor and will stops when reaching the outer limit switch.

Then type apimate input_.stage.prg

verify the resulting value: Hex-16 which represents the status of the limit switches Inner limit switch -- not active Outer limit switch -- active

Then type apimate moverew.prg

The rod starts moving inside the rotor and will stops when reaching the inner limit switch.

Then type apimate inputstage.prg

verify the resulting value: Hex-15 which represents the status of the limit switches Inner limit switch -4 active Outer limit switch --)not active

Then type apimate move40000.prg The rod moves to position 40000. Mark this position in the Rod static base.

Then type apimate move52800.prg The rod moves to position 52800. Mark this position in the Rod static base.

Verify 60mm+i- % mm between I marks

The rod starts moving outside the rotor and will stops when reaching the outer limit switch.


The rod starts moving inside the rotor and will stops when reaching the inner limit switch.


Verify 60mm+/- Y2 mm between marks

.1 ___________________ J.

ATCNRCAPPI.DOC

r I

V

1-20

I

(I

y ý-Zx

-T-2S

Documents

W GE Medical Systems