service manual - nrc

W GE Medical Systems

Technical Publications

Revision 2

ATC Option for use with the

Millennium TMMG Nuclear Imaging System

Service Manual

Printed for

GE Medical Systems

GE Medical Systems: telex 3797371 P.O. Box 414, Milwaukee, Wisconsin, 53201 U.S.A. (Asia, Pacific, Latin America, North America)

GE Medical Systems - Europe. Telex 698626 283 rue de la Miniere, B.P.34, 78533, Buc Cedex, France

COPYRIGHT@ 1999 BY ELGEMS LTD.

Acquisition and/or processing software and the related documentation are

confidential and proprietary information of ELGEMS Ltd. Only licensees of

ELGEMS Ltd. have a right to use the information contained herein. Only

licensees specifically granted copy and/or transfer rights have the right to copy

and/or transfer the information. Any unauthorized use, disclosure, assignment,

transfer or reproduction of this confidential information will be prosecuted to

the full extent of the Law.

DISCLAIMER

ELGEMS Ltd. shall not be liable nor obligated in any manner in respect of

bodily injury and/or property damage arising from the use of this software if

such use is not in strict compliance with instructions and safety precautions

contained in the relevant operating manuals and in all supplements thereto, in

all product labels, and according to all terms of warranty and sale of this

software, nor if any change not authorized by ELGEMS Ltd. is made to the

software contained herein.

WARNING

User provided programs or scripts are NOT validated nor warranted by

EL GEMS Ltd.

The use of data obtained using such programs is the sole responsibility of the

user.

Users exchanging files and diskettes should beware of the risk of software viruses.

Published by ELGEMS Ltd. P.O. Box 170 Tirat Hacarmel 30200 Israel. Tel: 972-4-8563666 Fax: 972-4-8577663

ELGEMS Publication Number MAN xxxx

LIST OF REVISIONS

ECO REV DATE DESCRIPTION PAGES IAPPROVED BY

Procedures for operating the ATC option on the Millennium MG system.

Corrections requested by NRC

Additions and Corrections requested by NRC

_______ j I

All

1-5, 1-10, 1-11, 3-7, 5-2, & 5-4.

1-12 & 5-4

Sergio Steinfeld

Sergio Steinfeld

Sergio Steinfeld

0

1

2

April 1999

May1999

July 1999

I I

TABLE OF CONTENTS

SECTION PAGE

CHAPTER 1 - SAFETY AND REGULATORY

1.1 Safety Guidelines ........................................................................................ 1-1 1.1.1 General ....................................................................................................... 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 General H azards ......................................................................................... 1-3 1.3.2 Electrical H azards ...................................................................................... 1-3 1.3.3 Radiation 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 Regulatory Inform ation ................................................................................. 1-12

CHAPTER 2 - DESCRIPTION

2.1 Overview ......................................................................................................... 2-1 2.1.1 General ....................................................................................................... 2-1 2.1.2 D escription of the ATC Option .................................................................. 2-1 2.1.3 Option Content ........................................................................................... 2-4 2.1.4 Prerequisites ............................................................................................... 2-5 2.1.5 Pioneer Kit .................................................................................................. 2-5 2.1.6 Installation Equipm ent ............................................................................... 2-5 2.2 Installation Procedure ..................................................................................... 2-6 2.3 Schedule .......................................................................................................... 2-6 2.4 Block D iagram ................................................................................................ 2-7

CHAPTER 3 - HARDWARE INSTALLATION

3.1 Overview ......................................................................................................... 3-1 3.2 Equipm ent Required ...................................................................................... 3-1 3.3 H ardw are Installation ...................................................................................... 3-1 3.4 Installing the cables ........................................................................................ 3-2 3.5 M ounting the Line Source into the Rod Unit .................................................. 3-3 3.6 Radiation Leakage Test ................................................................................... 3-6

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

TABLE OF CONTENTS (Continued)

SECTION PAGE

CHAPTER 4 - ATTENUATION CORRECTION CHECKS AND SYSTEM CALIBRATION

4.1 INTRODUCTION .......................................................................................... 4-1 4.2 Shutter Function and rod motion check .......................................................... 4-1

4.3 Blank Scan Acquisition ................................................................................... 4-6

4.3.1 Definition ................................................................................................... 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 Definition ................................................................................................... 4-7 4.4.2 Frequency of Calibration ............................................................................ 4-7 4.4.3 Procedure .................................................................................................... 4-7 4.5 Transmission Scan Uniformity Test ............................................................... 4-8 4.5.1 General definition ....................................................................................... 4-8 4.5.2 M easurement Condition ............................................................................. 4-8 4.5.3 M easurement equipment ............................................................................ 4-9 4.5.4 M easurement procedure ............................................................................. 4-9 4.5.5 Calculation and analysis ............................................................................. 4-9 4.6 Reporting values ............................................................................................. 4-9

CHAPTER 5 - PLANNED MAINTENANCE

5.1 Source Replacement ........................................................................................ 5-1 5.1.1 Disassembling the Rod Units ..................................................................... 5-2 5.1.2 Dismounting the Expended Line Sources .................................................. 5-3 5.2 Led Inspection ................................................................................................. 5-6 5.3 QC Procedure .................................................................................................. 5-6

MG ATC Service Manual Rev. No. 2 P.N. 490-3201-07 ii July 27, 1999

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. 2 P.N. 490-3201-07 1-1 July 27, 1999

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.

1.2 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.

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.

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.

CAUTION

(Cautious 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.

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

Rev. No. 2 July 27, 19991-2

1.1.2

Safety and Regulatory Safety Definitions

Safety and Regulatory Hazards

1.3

1.3.

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.

Radiation HazardsRA DL"TION


Rev. No. 2 July 27, 19991-3

HAZARDS

1 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 burns 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

1.3.3

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

WARNING Z/\ 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

Safety and Regulatory Hazards

Safety and Regulatory

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.

WARNING

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.


Rev. No. 2 July 27, 19991-4

Hazards

Safety and Regulatory Radiation Safeguards

1.4

Figure 1-1. ATC Rod Unit


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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. 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.

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. F

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.

Lever-

Safety and Regulatory Radiation Safeguards


Lever Lock Locking Screw Lever

Lever Locked Lever Unlocked

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


Rev. No. 2 July 27, 19991-6

Radiation Safeguards


1.5 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.


Rev. No. 2 July 27, 19991-7

Radiafion'Leak Test


1.6

1.6.1

SYMBOLS USED

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

C Alternating Current

S Protective Earthing Point

ION / Power

O OFF / Power OFF

0 OFF (only for part of equipment)

@ ) ON (only for part of equipment)

* Type B Equipment

.m J Input Power

G + Output Power

.1_. Functional Earth Ground

zj k Warning, Caution - consult accompanying documents

A Electrical Shock Hazard


Rev. No. 2 July 27, 19991-8

Symbols Used

1.6.2 System Specific Symbols

The system has a label with the following symbols.

Table 1:

Symbol Meaning

Shutter Unlocked

I Shutter Locked

i Shutter Open

O Shutter Closed


Rev. No. 2 July 27, 19991-9

Symbols UsedSafety and Regulatory

1.7 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.

(D 0

Figure 1-3. Rod Unit Safety Labels

0o

/ /

Figure 1-4. ATC Safety Labels


Rev. No. 2 July 27,19991-10

Safety LabelsSafety and Regulatory


Table 2. Safety Labels

WARNING: RAQKACWE MATERIA ENCUtOS 153 G 1- Msq On___

HANDLNG ftkuetbr: mw10r =• • AI08,N*3Vjd

P/N 490-3201-07 Chan 3 &5 5

VENWB) Nl 3U.I7~~XJ= 35401M APFMqTMAW ja8~E pemwm fAN EQ0#W LSM1M ~1MS"YNGTESMJ L&D0fl24

Shutter Status Label 70-5-3671-5102

2

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

705-3671-0802


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Safety Labels

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 601-1-2. 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 IEC 601-1-2 for immunity Class 1. The operating conditions are classified on the basis of performance criteria as defined in IEC 801-2.

The equipment complies with the following standards:

10 CFR Part 19 "Notices, Instructions and Reports to Workers: Inspections and Investigations"

10 CFR Part 20 "Standards for Protection Against Radiation"

10 CFR Part 32 "Specific Domestic Licences to Manufacture or Transfer Certain Items Containing By-product Material"

10 CFR Part 35 "Medical Use of By-product Material"


Rev. No. 2 July 27, 19991-12

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


Description

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 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:

b Communication with the host to manage the following functions:

motion control

scan range settings

limit sensing

parking absolute locations

b 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.


Overview

Description

3ase Unit

Yellow Warning

RADIATION

BEAMS

Rod UnitsWarning LED

Figure 2-1. ATC Assembly - General View

Yellow Warning LED

Rods Moved to Parking Position

Yellow Warning LED

Figure 2-2. ATC Assembly with Rod Units in Park Position


Rev. No. 2' July 27, 19992-3

Overview

Description

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:

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

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

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

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

MG ATC Service Manual Rev. No. 2

P.N. 490-3201-07 2-4 July 27, 1999

Overview

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

MG ATC Service Manual Rev. No. 2Z P.N. 490-3201-07 2-5 July 27, 1999

Description Overview

Installation Procedure

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

* 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.

0 One day to create the option specific correction maps


Rev. No. 2 July 27, 19992-6

Description

Description Block Diagram

2.4 BLOCK DIAGRAM

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

HAND-HELD CONTROLLER

COLISSIOr' SENSOR

GENIE P & R " ECG

TRIGGER

STARCAM 3000 4000 40001

COLISSION [COLLIMATO7RSENSOR

COLLIMATOR

COLLIMATOR

CART

Figure 2-3. System Block Diagram


Rev. No. 2 July 27, 19992-7

IMODE

Description Block Diagram

Block DiagramDescription


Rev. No. 2July 27, 19992-8

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 0'. 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.

MG ATC Service Manual Rev. No. 2' P.N. 490-3201-07 3-1 July 27, 1999

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

M-8 SCREWS (x7) / 4,Z-

ATC BASE 473-3201-0

M-12 SCREWS (x2)

- ROD HOLDER #4 502-3201-10

M-6 SCREWS (x6)

Figure 3-1. ATC Assembly


Rev. No. 2' July 27, 19993-2

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

The t53Gd 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.

Note]The 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 00.

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 ihe 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).

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

Rev. No. 2' July 27, 19993-3

WARNING

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

Mounting the Line Source into the Rod UnitHardware Installation


Source Holder . Securing Screws

Cover Plate

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

4 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).


Rev. No. 2' July 27, 19993-4



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

0 O~f

Figure 3-4. Mounting the Source into the Rod


Rev. No. 2. July 27, 19993-5


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 225' 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

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

Radiation Leakage TestHardware Installation

Hardware installation Radiation Leakage 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 5nCi (185 Bq) the machine is considered non-leaking

0

if I II

Surfaces to / be wiped

Figure 3-5. Checking for Radiation Leaks


Rev. No. 2, July 27, 19993-7

Radiation Leakage TestHardware Installation

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

NOTE: 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.


Rev. No. 2 July 27, 19994-1

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

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 The shutter Lever is in the Verify that the shutter was opened, OPEN ("I") 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

to the CLOSE ("0") position Verify that the shutter was closed, the the yLOw led i oFF.

mechanical Lever changed position to

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 (1"") position. to OPEN ("I") 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.


Rev. No. 2, July 27, 19994-2



Power off fail- safe+ 1- 1-

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 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

The shutter Lever is in the OPEN ('I") position. The Yellow Led is ON.

Verify that the shutter was closed, the The shutter Lever changes mechanical Lever change to CLOSE to the CLOSE ("0") position ("I") 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) = 1

(active low) t: 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 ("1") position OPEN ("I') position and the The yellow led is ON. Yellow Led is ON.


Rev. No. 2' July 27, 19994-3



lype Get input stage

Verify: Bit 3- shutter fully open

(active low) = 0 Bit 4 -shutter close

(active low) = 1

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 Verify: Bit 3- shutter fully open

(active low) = 1 Bit 4 -shutter close

(active low) = 0 Type

Rod motion test_____ +

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.

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

Bit 4 -shutter close (active low) = 1

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

Bit 3- shutter fully open (active low) = 1

Bit 4 -shutter close (active low) = 0

I t -r

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

______ J. I.


Rev. No. 2, July 27, 19994-4

Shutter Function and rod motion checkAttenuation Correction Checks And System Calibration


Type

Set output state 00010001

Bit 0- inner limit switch

(active low) = 1 Bit 1- outer limit switch

(active low) = 0 Type

COUNTMOVE

PREPREMOVE

80000

STARTMOVE

Verify that the Rod starts moving towards the inner position till reaching the limit switch.

Type

Set output-state 00010001

-Bit 0- inner limit switch (active low) = 0

Bit 1- outer limit switch (active low) = 1


(active low) 0 1

Bit 1- outer limit switch

(active low) 0 0

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


(active low) = 0

Bit 1- outer limit switch

(active low) = 1


Rev. No. 2" July 27, 19994-5


Attenuation Correction Checks And System Calibration Blank Scan Acquisition

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.


Rev. No. 2, July 27, 19994-6

PARAMETER ENTRY

DC•.'Ectaro numer 1 Qr 2

Att'orlZuti tViicnkfS•.- N'T!m 2

Tmanstissionr mask wlh mm 72 or 60 fWo LEG..EHR

Collimator LEGP or LEHR

P e CO'rrCtion PMT

Energy Correct1"m ECOR

Spatalli C or -cliion CoS7

Blank Scan AcquisitionAttenuation Correction Checks And System Calibration

Attenuation Correction Checks And System Calibration Source Profile Scan Acquisition

BLANK SCAN ATTENUATOR COVERING DETECTORFIELD OF VIEW

/~I i v *

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.

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

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.


Attenuation Correction Checks And System Calibration Source Profile Scan Acquisition

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

DetechT numner 1 or 2

Atnuatof thickness, r.rn 2

Colfimwaor LEGP or LEHR

Ph-torrtrurrpfier Cw.rection PMT

Enlrgy Corfaacml ECOR

Sparrl Coirrion Co57

Urnrormity Correctiorn 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.

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

4.5 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.


Rev. No. 2 July 27, 19994-8

Attenuation Correction Checks And System Calibration 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, 180' 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


Rev. No. 2 July 27, 19995-1

5.1.1 Disassembling the Rod Units

1. Bring the Gantry to the "heads opposed" position by selecting this option from the Acquisition Station main menu.

2. Rotate the Gantry so that Head-I is positioned at a 900 angle. Move both heads to the maximum out position. See Figure-

Screws

Figure 5-1. Gantry in "Heads Opposed" Position

3. Turn OFF the Gantry

4. Ensure that the Shutters on both rod units are closed, i.e., the lever is in the CLOSE position. (0)

5. Disconnect Rod Power Control cable # 475-3201-2 by unplugging connector P1

6. Remove the 3 M-6 screws holding the Rod unit to the Rod Holder on Head #1, and

carefully place it on a firm flat surface

7. Repeat step 5 & 6 to remove the Rod unit from Head #2.


Rev. No. 2 July 27, 19995-2

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 5-2. 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).

Pi,

Lead Lined Aluminum Source Container

S..... ................... Location of Container - Rod

Cover Plate Securing Allen Screw Alluminum

tonf

Plunger

Figure 5-3. Source Container

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


Rev. No. 2' July 27, 19995-3



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 5-4).

6. Push the plunger half the way in Step 2 in Figure 5-4).

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 5-4).

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 5-4).

9. Push the Plunger all the way in, and carefully turn the plunger fully CW (Step 5 in Figure 5-4).

10. Pull out the Plunger, extracting the source holder from the Rod Unit into the Lead-shielded Source Container (Step 6 in Figure 5-4).

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 5-4).

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.

WARNING

/Disposal of the used line sources must be in accordance with the regulatory procedures. Only qualified trained personnel or someone licensed by NRC or an Agreement State are considered suitable for source disposal


Source ReplacementPlanned Maintenance

Planned Maintenance

0

Ja

Figure 5-4. Extracting the Line Source From the Rod


Source Replacement

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.


Rev. No. 2' July 27, 19995-6

Planned Maintenance Led Inspection

EL QEMA S P.O.Box 170 - Tirat Hacarmel 30200 ISRAEL

Tel 972-4-8563666 - Fax 972-4-8577663

Dear reviewer Mr. Seung Lee, 27/7/99

According to your letter to Mr. Beebe dated on July 7,1999, we send you the attached letter with the required information to continue the review and evaluation of MG ATC Rod Unit p/n ASM 000415. This letter replaces the one I gave you in our last meeting on the 19/7/99.

The answers and explanations were inserted into your letter (bold letters) after each required clarification.

I would also like to inform you that we received the k number K991896 of the MG ATC system submission to the FDA for 51 OK approval. Attached the reference letter from FDA.

We would like to thank you for your cooperation, answering our questions and clarifying the requested data, hoping that now, this corrected and updated submission will fulfill the completion of the review and evaluation of the device.

If you have any questio , please contact me.

Sergio Steinfeld ý'•) MG ATC System En ier R&D Dept. Tel 972-4-8563642 Fax 972-4-8577662 E-Mail : serqio steinfeldt-elgqems.com

We are in the process of reviewing you're your application for ATC Rod Unit p/n ASM 000415 Model. However, in order to continue our review, we need the following information :

1. For the MA-0476-S- 117-S dated April 1, 1999, a. Please state how the effect of two source "L" deployment and Tc-99m

transmission on the bonding capability of the epoxy were taken into consideration.

See response on L.b

b. Please specify how the working life of the source was established. It appears in the application that the bonding capability of the epoxy was evaluated using a single source.

The Gd-153 source bonding capabilities is depended on the source selfirradiation only. The interference between the two Gd153 sources and influence of the external one (which can be only patient with administrated radiopharmaceutical) is negligible. Each Gd-153 source designed as beam limited device and attached to camera detector as shown in Operation Manual, Figure 1-1. Each source equipped with lead shielding and collimator provided strictly narrow and parallel radiation beam as shown in Appendix F of original submission, Transmission Source Radiation Profile, Page F-3. In addition, the two source "L" deployment provides no interference between the sources. The radiation dose superposition has effect only inside Transmission Field of View area between the source rods where patient body should be located.

The Gd-153 source bonding capabilities was estimated on basis of DuPont approved NER-462 Fe-55 source evaluation( see appendix D of the original submission, page D-3 ), which contains irradiation test results of the epoxy for expected life of the source of 5 years.

c. Please clarify how the manufacturing tolerance. The note 8 in Attachment 2 states that "Minimum and maximum dimensions shown are nominal values, this standard tolerances <not to exceed ±. 12> apply to each dimension. However, in the block, the tolerances are specify as ± 0.10 and + 0.05 for .xx and .xxx respectively. What tolerance is used for ATC Rod Unit. ?

Note 8 states the tolerances used (units are in inches).

2. Please provide the external radiation profiles as well as radiation exposure for workers and other personnel when the patient, already injected either TI-201 or Tc-99m, is inside the radiation beams.

Both emission radiation emitted from patient body and transmission radiation emitted from transmission sources determine the radiation exposure for workers and other personnel. According to device prototype evaluation test results (see Appendix F of the original submission file, page F-3, Transmission Source Rod Radiation Profile Test), the maximal transmission exposure from both sources does not exceed 0.02 mR/h outside transmission field of view (page F-5, §2 of Test Results). The typical value of radiation exposure is less than 0.01 mR/h. Therefore, the radiation dose from transmission sources per nuclear medicine cardiac procedure (where the device is intended to be used) is 0.01 x 15 / 60 = 0.0025 mR, where 15 min is usual procedure duration. One can conclude the transmission radiation emitted from transmission sources is comparable to regular radiation background and considered as negligible.

The emission radiation emitted from patient body and reached nuclear medicine department personnel (in terms of nuclear medicine facility technologist) is use to be much higher. For radiation worker in a nuclear medicine department, the annual effective dose received is generally of the order of 200 mR. Specifically, radiation dose to nuclear medicine technologists in cardiac procedure is 0.35 mR (Nuclear Medicine in Clinical Diagnosis and Treatment. Edited by I.P.C. Murray,..., 1998, pp.1659,1670).

Finally, the radiation dose addition to worker and other personnel in a nuclear medicine department caused by transmission source radiation is less than 1%. The dose from both emission and transmission radiation is not be exceed 10 CRF Part 20 occupational and public dose limits.

3. Please provide the radiation levels and exposure rates during other conditions of use, such as leak testing , calibration, etc.

The occupational exposure during loading and unloading of the sources is less than 0.04 mR (see Test Report in Appendix F, page F-13 of original submission).When leak testing to be performed the occupational exposure is considered to be comparable to background level (see Appendix F of the original submission, Transmission Source Rod Radiation Profile Test - page F-5, §3 )

4. Please provide the training requirements for field engineers to remove, replace, install, and repair of the Rod Units.

Qualified field engineers should take part of the MG ATC Option course in the GE Training center in Milwaukee.

5. Please provide the requirements and qualifications for the device users.

The device users should be graduates of basic training of nuclear medicine technologist (according to the local regulations). No other special requirements and qualifications are required for the device users to operate the MG AC System.

6. Please provide the corrected warning statement in Service Manual page 5-4.

Attached updated Service Manual (Rev 2). Please, remove the Rev. 1 dated on May 16, 1999 from appendix B of the response file sent on 1/6/99 and insert this updated version Rev. 2, July 27, 1999 instead.

The warning statement in page 5-4 was corrected. In page 1-12, I added references to all applicable CFR standards for the MG AC system.

I would like to add the following information we clarified on our last meeting of the 19/7/99 :

a) The clinical use of the Attenuation Correction System is cardiac imaging. b) The maximum radioactive activity of the device line source is 540 mCi. The

AC Attenuation Correction System includes two devices with its own line sources. See fig. 1.1 on the Operation Manual. See attached photo of both devices assembled on the dual head camera.

c) All the symbols in section 1.6, subsection 1.6.1, IEC Symbols of the Service Manual, are given in standard UL2601-1, Medical Electrical Equipment, Part 1: General Requirements for Safety, Second Edition, Clause 6. UL2601-1 is the relevant Underwriters Laboratory standard for nuclear medicine equipment, including the labels. Compliance to the UL standard is recognized by the FDA as one of their requirements for FDA clearance (510(k)) to market the NM device in the USA.

d) Attached copy of ISO 9001 Elgems certificate of approval.

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration Center for Devices and Radiological Health Office of Device Evaluation Document Mail Center (HFZ-401) 9200 Corporate Blvd.

June 03, 1999 Rockville, Maryland 20850

ELGEMS, LTD. 510(k) Number: K991896 P.O. BOX 170 Received: 03-JUN-1999 TIRAT HACARMEL, Product: MG ATC: ATTENUATION ISRAEL CORRECTION SYSTEM ATTN: LAOR DAN FOR DUAL-HEAD

VARIABLE-ANGLE GAMMA

The Center for Devices and Radiological Health (CDRH), Office of Device Evaluation (ODE), has received the Premarket Notification you submitted in accordance with Section 510(k) of the Federal Food, Drug, and Cosmetic Act (Act) for the above referenced product. We have assigned your submission a unique 510(k) number that is cited above. Please refer prominently to this 510(k) number in any future correspondence that relates to this submission. We will notify you when the processing of your premarket notification has been completed or if any additional information is required. YOU MAY NOT PLACE THIS DEVICE INTO COMMERCIAL DISTRIBUTION UNTIL YOU RECEIVE A LETTER FROM FDA ALLOWING YOU TO DO SO.

On January 1, 1996, FDA began requiring that all 510(k) submitters provide on a separate page and clearly marked "Indication For Use" the indication for use of their device. If you have not included this information on a separate page in your submission, please complete the attached and amend your 510(k) as soon as possible. Also if you have not included your 510(k) Summary or 510(k) Statement, or your Truthful and Accurate Statement, please do so as soon as possible. There may be other regulations or requirements affecting your device such as Postmarket Surveillance (Section 522(a)(1) of the Act) and the Device Tracking regulation (21 CFR Part 821). Please contact the Division of Small Manufacturers Assistance (DSMA) at the telephone or web site below for more information.

Please remember that all correspondence concerning your submission MUST be sent to the Document Mail Center (HFZ-401) at the above letterhead address. Correspondence sent to any address other than the Document Mail Cencer will not be considered as part of your official premarket notification submission. Because of equipment and personnel limitations, we cannot accept telefaxed material as part of your official premarket notification submission, unless specifically requested of you by an FDA official. Any telefaxed material must be followed by a hard copy to the Document Mail Center (HFZ-401).

You should be familiar with the manual entitled, "Premarket Notification 510(k) Regulatory Requirements for Medical Devices" available from DSMA. If you have other procedural or policy questions, or want information on how to check on the status of your submission (after 90 days from the receipt date), please contact DSMA at (301) 443-6597 or its toll-free number (800) 638-2041, or at their Internet address http://www.fda.gov/cdrh/dsmamain.html or me at (301) 594-1190.

Sincerely yours,

Marjor e Shulmn ' Consumer Safety Officer Premarket Notification Staff

Public Health Service

Iso 9000

,'i$S U r

The ýE-. ._.A

Certificate of Approval

This is to certify that the Quality Management System of

EL GEMS LTD.

has been audited by SI1 and found to comply with the Quality

Management Standard: S/ ISO 9001

And EN46001

The Certificate is granted in accordance with SII's Rules for the Cerfication of Quality Systems

(S1 procedure-002). The validity of the Certificate is subject to the continuous maintenance of the

Quality System according to the above standard, and the follow-up surveillance performed by Sll.

scope: DESIGN, MANUFACTURE AND SERVICE SUPPORT OF NUCLEAR

MEDICINE DIAGNOSTIC IMAGING SYSTEMS.

Date of initial approval: Date of issue: Date of expiration: ZI VA PA T/R

Director GeneralNo: 16563

Accredited by

h e R v A

16 .07 01 . 01 31 . 12

1997 1999 2001

- MG/CSE- A TC: Transmission Attenuation Corrected Tomoaraphv

service manual - nrc

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