ML20198G261
| ML20198G261 | |
| Person / Time | |
|---|---|
| Issue date: | 12/21/1998 |
| From: | Jankovich J NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | Kay S ELSCINT, INC. |
| Shared Package | |
| ML20198G268 | List: |
| References | |
| SSD, NUDOCS 9812290038 | |
| Download: ML20198G261 (1) | |
Text
_
[r December 21, 1998 Mr. Steven M. Kay Director, Regulatory Affairs and Quality Assurance Elscint, Inc.
22 Paris Avenue Rockleigh, NJ 07647
Dear Mr. Kay:
1 Based on the information submitted in your letter dated November 11,1998, we continue to conclude that the Model Transact Transmission Line Source Housing is acceptable for licensing purposes in accordance with the conditions of the enclosed registration certificate (NR-1032-D-101-S).
Please be advised that you must manufacture and distribute the product in accordance with the statements and. representations contained in your application, with enclosures thereto, Ad the Information set out in your registration certificate. As a general rule, you must request and
~
l.
obtain an amendment to the certificate before you make changes or modifications to the information submitted to obtain the certificate.
Please read over the registration certificate in its entirety and notify us immediately of any errors or omissions.
l-
- You are obligated to notify us promptly in writing should you decide to no longer manufacture or offer service support for the product.
l-a Please be aware that, as a holder of an NRC registration, you may be subject to the NRC's licensing fees in accordance with 10 CFR Part 170, and annual fees in accordance with 10 CFR Part 171. If you have any questions concerning the fee requirements, please contact the License Fee and Debt Collection Branch at (301) 415-6096.
l-if you have any questions, please contact me at (301) 415-7904 or Mr. John Lubinski at (301) 415-7868.
l Sincerely, 5
John 1. Jankovich, Sr. Engineer Materials Sa'oty Branch Division of Industrial and Medical Nuclear Safety Office of Nuclear Material Safety
Enclosure:
As stated l
cc w/ encl: SKimberley, LFDCB Distribution:
IMNS r/f SSD-98-99 NE01 l~
SSD File # NR-1032-D-101-S DOCUMENT NAM 6; H:\\SSDFILES\\ LETTERS \\N1032101. CMP To receive a copy of this document,Indcate in the box: 'C' = Copy without attachment / enclosure
'E' = Copy with attachment / enclosure "N" - No copy OFFICE -
IMNS J t' JMNS
, lld l
l NAME JJankovich/jj rf'[
JLubinski#
DATE 12M//98 V //
12/tf98 0
OFFICIAL RECORD COPY I f 9812290038 981221
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REGISTRY OF' RADIOACTIVE SEALED-SOURCES AND DEVICES L
SAFETY' EVALUATION OF DEVICE (AMENDMENT OF PAGE 1 OF 7, December 21, 1998)
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NO.: NR-1032-D-101-S DATE: October 24, 1997 PAGE 1 OF 7 l
l DEVICE TYPE: Transmission Line Source Housing i.
l MODEL:
Transact l.;
DISTRIBUTOR:
Elscint, Inc.
22 Paris Avenue Rockleigh,.'NJ 07647-2605 MANUFACTURER:
Elscint, Ltd.
f PB 550, Haifa 31004 l
Israel t-SEALED SOURCE MODEL DESIGNATION:
North American Scientific Model MED3604 i
JSOTOPE:
MAXIMUM ACTIVITY:
Gadolinium-153 300 millicuries (11.1 Gbq)
LEAK TEST FREOUENCY:
6 Months PRINCIPAL USE:
(B) Medical Radiography CUSTOM DEVICE:
YES X
NO L
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REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE NO,: NR-1032-D-101-S DATE: October 24, 1997 PAGE 2 OF 1 DEVICE TYPE:
Transmission Line Source Housing DESCRIPTION:
The Transact is intended for use with the Cardial gamma camera, and contains 300 millicuries per source housing.
Two source housings are usually installed on each Cardial gamma camera.
The source housing is designed to hold a sealed source installed by the user, and is manufactured and distributed as an accessory device not containing radioactive material.
The outside dimensions of the device are 36 x 120 x 475 mm (1.42 x 4.72 x 18.70 inches).
It is constructed of aluminum and steel, with lead shielding.
The source rod is mounted in a cavity on a rotating rod within a lead shield /collimator.
The source is exposed (shutter opened) by rotating the rod so that the source faces the collimator slit.
This rotating rod is mounted on a solenoid.
In case of a power failure or interrupt, a spring mechanism rotates the rod back to the closed position.
The source can also be returned to the closed position by use of a manual lever on the end of the device.
A yellow LED on the gantry and the open position of the manual lever indicate that the source is in the open position.
An unlit LED and the closed position of the manual lever (when the lever is not visible in the lever window) indicates that the source is in the closed position.
The thin fan-shaped beam is collimated such that the beam angle in the fan plane and with the shutter open, at 30 cm (11.81 inches) from the collimator slit is approximately 20 degrees.
Source replacement will be approximately yearly.
During source removal and installation, the shipping container that the source is shipped from the source manufacturer in is screwed to the source cavity of the source housing.
The source, mounted in its metal holder, is pushed from the shipping container into the device.
The alignment of the shipping container and the source housing prevents any bending of the source during the installation process.
The device is portable to the extent that it can be detached from the gantry by the operator for secure storage when not in use.
The source remains in the source housing at all times, including storage.
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i REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE NQmi NR-1032-D-101-S DATR: October 24, 199/
PAGE 3 OF 7 DEVICE TYPE:,Tranamission Line Source Housing DIAGRAM:
See attachments 1 and 2.
LABELING:
The outside cover of each source housing will contain three labels.
The labels are made of Lexan attached to the source housing by Mac-Tac adhesive.
The labels contain the following information:
Label 1:
the words " Warning: Radioactive Material Enclosed" radiation trefoil symbol
- Gd-153 activity
- date of manufacture (mm/dd/yy)
Label 2:
e distributor name model number and serial number of device e
Label 3, attached next to the manual on/off lever:
the words " CAUTION: RADIATION IS ON WHEN RED TIP IS VISIBLE' CONDITIONS OF NORMAL USEt The source housing will be used as an accessory installed on a scintillation camera system in a clinical environment of a nuclear medicine imaging facility, and may be removed from the camera system when not in use for storage.
The source housing is intended for use only in clean medical (benign) environments.
The device should not be subjected to conditions exceeding those specified by the ANSI 77C64444 rating for source performance.
PROTOTYPE TESTING:
The manufacturer reports that the source housing passed shutter testing that simulated approximately 18 years of use; passed MIL-STD-810D, Method 514.2 Procedure 1, for vibration caused by transportation; and passed drop testing from typical mounting height.
)
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE NO.: NR-1032-D-101-S DATE: October 20 1997 PAGE 4 OF 7 DEVICE TYPE:
Transmission Line Source Housing PROTOTYPE TESTING (cont. ) :__
No bend test was performed on the source rod, due to the fact that the source should not experience bending during use, installation, and removal.
During use, the source remains in a rod source holder and does not leave the source housing.
During installation, the shipping container that the source is shipped from the source manufacturer in is screwed to the source cavity of the source housing.
The source, mounted in its metal holder, is pushed from the rigid shipping container into the source housing.
The alignment of the shipping container and the source housing prevents any bending of the source during the installation process.
The source housing itself is rigid, preventing bending of the source within the source housing.
EXTERNAL RADIATION LEVELS:
The following are the dose rates reported by the manufacturer, using a 300 millicurie (11.1 GBq) Gd-153 source.
Max. Radiation Level (mrem /hr) / (uSv/hr)
Distance (cm/in)
Shutter open*
Shutter closed contact
<6.0/0.060
<0.08/0.0008 30/11.81
<4.0/0.040
<0.04/0.0004 100/39.37
<0.5/0.005
<0.02/0.0002
- values are for collimator plane.
Since the beam is highly collimated, the values outside the collimator plane would be equal to the shutter closed values.
The manufacturer reports that for a 300 millicurie (11.1 GBq) source, a typical source exchange, lasting approximately 10 seconds, would result in an exposure of less than 0.027 mrem (0.00027 uSv) to the hands, with a typical exposure nearer to 0.006 mrem (0.00006 uSv).
l l
A typical patient procedure (assuming 15 minutes), two 300 mci (11.1 GBq) sources, and considering only the contribution from the Transact source housing), would result in a patient exposure of less than 4.2 mrem /hr (0.042 uSv/hr) at 30 cm (11.81 inches),
with a patient dose less than 2.15 mrem (0.0215 uSv).
l l
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l.-
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE HQ 1 NR-1032-D-101-S DATE: October 24, 1997 PAGE 5 OF 7 l
DEVICE TYPE:
Transmission Line Source Housing
(
OUALITY, ASSURANCE AND CONTROL:
The manufacturer states that the source housings are designed and manufactured in accordance with the ISO 9001 standard.
The QA/QC procedures include:
L
- An initial inspection of incoming materials to ensure that I
all parts are manufactured according to the standard drawings.
- Before shipment, each source h'ousing is tested as follows:
Radiation levels:
measurements are made to ensure that i
radiation level measurements with shutter in the closed position are within specification limits, l
Shutter reliability:
tested to 1080 cycles with sources without failure, the equivalent of l
approximately one year's work.
Note that the sources are usually replaced on a yearly basis, and inspection and maintenance will be performed on the source housing at that time.
Power failure:
check to ensure that the fail safe functicn operates properly.
- Upon initial source loading and subsequent source exchanges, l
the opening of the source-shipping container will be wipe tested.
This testing is in lieu of wipe testing of the source proper; due to loading procedures, the source is not L
directly accessible for wipe testing.
- Upon initial receipt and installation of the source housings l
and initial loading of the source, radiation level measurements are made to verify that they are within specification limits, and the shutter is tested for 180 cycles.
- After each source exchange, the shutter mechanism will be tested for correct operation in accordance with procedures that the manufacturer will provide to the user.
1
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REGISTRY OF FADICACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE NO,: NR-1032-D-101-S DATE: October 24, 1997 PAGE 6 OF 7 DEVICE TYPE:
Transmission Line Source Housing LIMITATIONS AND/OR OTHER CONSIDERATIONS OF USE:
- The source housing shall be serviced, and initially installed, by Elscint, or other persons specifically licensed by the NRC or an Agreement State to perform such a :tivities.
- The source housing shall be distributed only to persons authorized by Section 35.11 of 10 CFR Part 35, or an equivalent Agreement State regulation.
- REVIEWER NOTE: Administrative procedures are required for safe operation and maintenance of the source housing, for source exchange, and for the control, installation, removal, and storage of the source housings as the source housings are designed to allow installation on and removal from the gantry for storage.
- REVIEWER NOTE: Administrative procedures are required to ensure that after each source exchange, the shutter mechanism will be tested for correct operation in accordance with procedures that the manufacturer will provide to the user.
- REVIEWER NOTE: Administrative procedures are required to ensure that upon initial source loading and subsequent source exchanges, the opening of the source-shipping container will be wipe tested.
This testing is in lieu of wipe testing of the source proper; due to loading procedures, the source is not directly accessible for wipe testing.
- The source housing shall be leak tested at intervals not to exceed 6 months using techniques capable of detecting 0.005 microcurie (185 Bq) of removable contamination.
- Handling, storage, use, transfer, and disposal:
To be determined by the licensing authority.
- This registration sheet and the information contained within the references shall not be changed without the written consent of the NRC.
.(1
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i 1
1 i
REGISTRY OF RADIOACTIVE SEALF4 SOURCES AND DEVICES l
SAFETY EVALUATICW OF DEVICE l
NO.:. NR-1032-D-101-S DAIR1 October 24, 1997 PAGE 7 OF 7 l'
j DEVICE TYPE:
Transmission Line Source Housing I
j SAFETY ANALYSIS
SUMMARY
Based on'our review of the information and test data cited below, we conclude.that the Elscint Model Transact line source housing i
is acceptable f.or licensing purposes as specified in this certificate.
Furthermore, we conclude that the Model Transact line source housing would be expected to maintain its integrity for normal i
conditions of use and accidental conditions which might occur during uses specified in this certificate.
i l
REFERENCES:
l The following supporting documents for the Model Transact l
transmission line source housing are hereby incorporated by l
reference and are made-a part of this registry document.
- Elscint, Inc. application dated March 15, 1996, with enclosures thereto.
- Elscint, Inc. letters dated September 26, 1997, June 12, 1997, June 10, 1997, October 17, 1996, and August 5,
- 1996, with enclosures thereto.
l-L
- Elscint, Inc.
facsimiles dated October 23, 1997, l
September 30, 1997, July 23, 1997, July 6, 1997, March 12, 1997, and August 2, 1996, with enclosures thereto.
- Elscint, Israel facsimile dated June 18, 1997, with enclosures thereto.
i ISSUING AGENCY:
l U.1. Nuclear Regulatory Commission Date:
October 24, 1997 Reviewer:
MM I
- su A Mic ele L. Burgess
[
Date:
October 24, 1997 Concurrence: /
Steven L.
Baggett I
l l
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REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE h NR-1032-D-101-S DATE: October 24, 1997 ATTACHMENT 1
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REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE HQ,_I, NR-1032-D-101-S DATE: October 24, 1997 ATTACHMENT 2 x
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I December 21, 1998 Mr. Steven M. Kay Director, Regulatory Affairs and Quality Assurance Elscint, Inc.
22 Paris Avenue Rockleigh, NJ 07647
Dear Mr. Kay:
Based on the information submitted in your letter dated November 11,1998, we continue to conclude that the Model Transact Transmission Line Source Housing is acceptable for licensing purposes in accordance with the conditions of the enclosed registration certificate (NR-1032-D-101-S).
Please be advised that you must manufacture and distribute the product in accordance with the statements and representations contained in your application, with enclosures thereto, and the information set out in your registration certificate. As a general rule, you must request and obtain an amendment to the certificate before you make changes or modifications to the information submitted to obtain the certificate.
Please read over the registration certificate in its entirety and notify us immediately of any errors or omissions.
You are obligated to notify us promptly in writing should you decide to no longer manufacture or offer service support for the product.
Please be aware that, as a holder of an NRC registration, you may be subject to the NRC's licensing fees in accordance with 10 CFR Part 170, and annual fees in accordance with 10 CFR Part 171. If you have any questions concerning the fee requirements, please contact the License Fee and Debt Collection Branch at (301) 415-6098.
If you have any questions, please contact me at (301) 415-7904 or Mr. John Lubinski at (301) 415-7868.
Sincerely, Johnh. Jankovich, Sr. Engineer Materials Safety Branch Division of Industrial and Medical Nuclear Safety Office of Nuclear Material Safety And Safeguards
Enclosure:
As stated cc w/ encl: SKimberley, LFDCB Distribution:
IMNS r/f SSD-98-99 NE01 SSD File # NR-1032-D-101-S DOCUMENT NAME: H:\\SSDFILES\\ LETTERS \\N1032101. CMP To receive a copy of this document. Indicate in the box: "C" = Copy without attachment / enc:osure "E" = Copy with attachment / enclosure "N" = No copy OFFICE IMNS j (' JMNS
. [ld l
l NAME JJankovich/jj / f[
JLubinski Jf2 DATE 12FI/98 V //
12/24'98 0
OFFICIAL RECORD COPY f(ji.EYOu.5 $~ //0
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REGISTRY OF' RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (AMENDMENT OF-PAGE 1.OF 7, December 21, 1998)
~
.NO.; NR-1032'-D-101-S DATE: October 24, 1997 PAGE 1 OF 7
-_ DEVICE TYPE: Transmission Line Source Housing
,s i
I MODEL:
Transact 4
l I
DISTRIBUTOR:
Elscint, Inc.
t~
22 Paris Avenue Rockleigh, NJ 07647-2605 MANUFACTURER:
Elscint, Ltd.
PB 550,.Esifa 31004 Israel SEALED SOURCE'MODEL DESIGNATION:
North American Scientific Model MED3604
)
' ISOTOPE:
MAXIMUM ACTIVITY:
Gadolinium-153 300 millicuries (11.1 Gbq)
LEAK TEST FREOUENCY:
6 Months PRINCIPAL USE:
(B) Medical Radiography L:
l-
- CUSTOM DEVICE:
YES X
NO L
I i
I -.
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I i
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i REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE NO,: NR-1032-D-101-S DATE: October 24, 1997 PAGE 2 OF 7 DEVICE TYPE:
Transmission Line Source Housing DESCRIPTION:
l The Transact is intended for use with the Cardial gamma camera, and contains 300 millicuries per source housing.
Two source housings are usually installed on each Cardial gamma camera.
The source housing is designed to hold a sealed source installed by the user, and is manufactured and distributed as an accessory device not containing radioactive material.
The outside dimensions of the device are 36 x 120 x 475 mm (1.42 x 4.72 x 18.70 inches).
It is constructed of aluminum and steel, with lead shielding.
The source rod is mounted in a cavity on a rotating rod within a lead shield /collimator.
The source is exposed (shutter opened) by rotating the rod so that the source faces the collimator slit.
This rotating rod is mounted on a solenoid.
In case of r power l
failure or interrupt, a spring mechanism rotates the rod back to the closed position.
The source can also be returned to the closed position by use of a manual lever on the end of the device.
A yellow LED on the gantry and the open position of the manual lever indicate that the source is in the open position.
An unlit LED and the closed position of the manual lever (when the lever is not visible in the lever window) indicates that the source is in the closed position.
l The thin fan-shaped beam is collimated such that the beam angle in the fan plane and with the shutter open, at 30 cm (11.81 inches) from the collimator slit is hpproximately 20 degrees.
Source replacement will be approximately yearly.
During source l
removal and installation, the shipping container that the source i
is shipped from the source manufacturer in is screwed to the source cavity of the source housing.
The source, mounted in its metal holder, is pushed from the shipping container into the l
device.
The alignment of the shipping container and the source l
housing prevents any bending of the source during the installation process.
The device is portable to the extent that it can be detached from the gantry by the operator for secure storage when not in use.
The source remains in the source housing at all times, including storage.
i l
l
l t
l'.
I l
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE Npal NR-1032-D-101-S DATE: October 24, 1997 PAGE 3 OF 7 l
DEVICE TYPE:
Transmission Line Source Housing DIAGRAM 1 See attachments 1 and 2.
LABELING:
The outside cover of each source housing will contain three
[
labels.
The labels are made of Lexan attached to the source housing by Mac-Tac adhesive.
The labels contain the following information:
Label 1:
l
- the words " Warning: Radioactive Material Enclosed" radiation trefoil symbol l
l
- Gd-153 activity date of manufacture (mm/dd/yy)
Label 2:
distributor name model number and serial number of device e
Label 3, attached next to the manual on/off lever:
- the words~" CAUTION: RADIATION IS ON WHEN RED TIP IS VISIBLE" l
CONDITIONS OF NORMAL USE:
The source housing will be used as oc accessory installed on a scintillation camera system in a clinical environment of a nuclear medicine imaging facility, and may be removed from the camera system when not in use for storage.
The source housing is intended for use only in clean medical (benign) environments.
The device should not be subjected to conditions exceeding those specified by the ANSI 77C64444 rating for source performance.
l PROT,OTYPE TESTING:
The manufacturer reports that the source housing passed shutter testing that simulated approximately 18 years of use; passed MIL-STD-810D, Method 514.2 Procedure 1, for vibration caused by transportation; and passed drop testing from typical mounting height.
l l
)
l l
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE NO,t NR-1032-D-101-S DATE: October 24, 1997 PAGE 4 OF 7 DEVICE TYPE:
Transmission Line Source Housing PROTOTYPE TESTING (cont.)-
No bend test was performed on the source rod, due to the fact that the source should not experience bending during use, installation, and removal.
During use, the source remains in a rod source holder and does not leave the source housing.
During installation, the shipping container that the source is shipped from the source manufacturer in is screwed to the source cavity
[
of the source housing.
The source, mounted in its metal holder, is pushed from the rigid shipping container into the source housing.
The alignment of the shipping container and the source housing prevents any bending of the source during the installation process.
The source housing itself is rigid, preventing bending of the source within the source housing.
EXTERNAL RADIATION LEVELS:
}
The following are the dose rates reported by the manufacturer, using a 300 millicurie (11.1 GBq) Gd-153 source.
Max. Radiation Level (mrem /hr)/(usv/hrl Distance (cm/ int Shutter cuen*
Shutter closed contact
<6.0/0.060
<0.08/0.0008 30/11.81
<4.0/0.040
<0.04/0.0004 100/39.37
<0.5/0.005
<0.02/0.0002
- values are for collimator plane.
Since the beam is highly collimated, the values outside the collimator plane would be equal to the shutter closed values.
The manufacturer reports that for a 300 millicurie (11.1 GBq) source, a typical source exchange, lasting approximately 10 seconds, would result in an exposure of less than 0.027 mrem (0.00027 uSv) to the hands, with a typical exposure nearer to 0.006 mrem (0.00006 uSv).
A typical patient procedure (assuming 15 minutes), two 300 mci (11.1 GBq) sources, and considering only the contribution from the Transact source housing), would result in a patient exposure of less than 4.2 mrem /hr (0.042 us r/hr) at 30 cm (11.81 inches),
with a patient dose less than 2.15 mrem (0.0215 uSv).
f l
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i i
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE NO,; NR-1032-D-101-S DATE: October 24,.1997 PAGE 5 OF 7 DEVICE TYPE:
Transmission Line Source Housing OUALITY ASSURANCE AND CONTROL:
The manufacturer states that the source housings are designed and manufactured in accordance with the ISO 9001 standard.
The QA/QC l
procedures include:
L
- An initial inspection of incoming materials to ensure that all parts are manufactured according to the standard drawings.
- Before shipment, each source h'ousing is tested as follows:
- ' Radiation levels:
measuremants are made to ensure that i
radiation level measurements with shutter in the closed i
position are within specification limits, Shutter reliability:
tested to 1080 cycles with sources without failure, the equivalent of l-approximately one year's work.
Note that the sources j
are usually replaced on a yearly basis, and inspection and maintenance will be performed on the source housing l
at that time.
Power failure:
check to ensure that the fail safe function operates properly.
- Upon initial source loading and subsequent source exchanges, the opening of the source-shipping container will be wipe tested.
This testing is in lieu of wipe testing of the i
source proper; due to loading procedures, the source is not directly accessible for wipe testing.
- Upon initial receipt and installation of the source housings and initial loading of the source, radiation level measurements are made to verify that they are within L
specification limits, and the shutter is tested for 180 cycles.
- After each source exchange, the shutter mechanism will be l
-tested for correct operation in accordance with procedures that the manufacturer will provide to the user.
l-4 J
e
~
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(
)
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE NO : NR-1032-D-101-S DATE: October 24, 1997 PAGE 6 OF 7 DEVICE TYPE:
Transmission Line Source Housing LIMITATIONS AND/OR OTHER CONSIDERATIONS OF USE:
- The source housing shall be serviced, and initially installed, by Elscint, or other persons specifically licensed by the NRC or an Agreement State to perform such activities.
- The source housing shall be distributed only to persons authorized by Section 35.11 of 10 CFR Part 35, or an equivalent Agreement State regulation.
- REVIEWER NOTE: Administrative procedures are required for safe operation and maintenanca of the source housing, for source exchange, and for the control, installation, removal, and storage of the source housings as the source housings are designed to allow installation on and removal from the gantry for storage.
- REVIEWER NOTE: Administrative procedures are required to ensure that after each source exchange, the shutter mechanism will be tested for correct operation in accordance with procedures that the manufacturer will provide to the user.
- REVIEWER NOTE: Administrative procedures are required to ensure that upon initial source loading and subsequent source exchanges, the opening of the source-shipping container will be wipe tested.
This testing is in lieu of wipe testing of the source proper; due to loading procedures, the source is not directly accessible for wipe testing.
- The source housing shall be leak tested at intervals not to exceed 6 months using techniques capable of detecting 0.005 microcurie (185 Bq) of removable contamination.
- Handling, storage, use, transfer, and disposal:
To be determined by the licensing authority.
- This registration sheet and the information contained within the referencea shall not be changed without the written consent of the NRC.
i REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE NO : NR-1032-D-101-S DATE: October 24, 1997 PAGE 7 OF 7 DEVICE TYPE:
Transmission Line Source Housing SAFETY ANALYSIS
SUMMARY
Based on our review of the information and test data cited below, we conclude that the Elscint Model Transact line source housing is acceptable for licensing purposes as specified in this certificate.
Furthermore, we conclude that the Model Transact line source housing would be expected to maintain its integrity for normal conditions of use and accidental conditions which might occur during uses specified in this certificate.
REFERENCES:
The following supporting documents for the Model Transact transmission line source housing are hereby incorporated by reference and are made a part of this registry document.
- Elscint, Inc. application dated March 15, 1996, with enclosures thereto.
- Elscint, Inc. letters dated September 26, 1997, June 12, 1997, June 10, 1997, October 17, 1996, and August 5,
- 1996, with enclosures thereto.
Elscint, Inc.
facsimiles dated October 23, 1997, September 30, 1997, July 23, 1997, July 6, 1997, March 12, 1997, and August 2, 1996, with enclosures thereto.
- Elscint, Israel facsimile dated June 18, 1997, with enclosures thereto.
ISSUING AGENCY:
U.S. Nuclear Regulatory Commission Date:
October 24. 1997 Reviewer:
MM
'#-'A Mic ele L. Burgess
[
Date:
October 24, 1997 Concurrence.: /
Steven L.
Baggett
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REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE q
h NR-1032-D-101-S DATE:~ October 24, 1997 ATTACHMENT 1
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3 REGISTRY OF RADIOAC' JIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE
@ g NR-1032-D-101-S DATE: October 24, 1997 ATTACHMENT 2
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December 21, 1998 Mr. Steven M. Kay Director, Regulatory Affairs and Quality Assurance Elscint, Inc.
22 Paris Avenue Rockleigh, NJ 07647
Dear Mr. Kay:
Based on the information submitted in your letter dated November 11,1998, we continue to conclude that the Model Transact Transmission Line Source Housing is acceptable for licensing purposes in accordance with the conditions of the enclosed registration certificate (NR-1032-D-101-S).
Please be advised that you must manufacture and distribute the product in accordance with the j
statements and representations contained in your application, wi:h enclosures thereto, and the information set out in your registration certificate. As a general rule, you must request and i
obtain an amendment to the certificate before you make changes or modifications to the information submitted to obtain the certificate.
Please read over the registration certificate in its entirety and notify us immediately of any errors or omissions.
You are obligated to notify us promptly in writing should you decide to no longer manufacture or offer service support for the product.
Please be aware that, as a holder of an NRC registration, you may be subject to the NRC's licensing fees in accordance with 10 CFR Part 170, and annual fees in accordance with 10 CFR Part 171. If you have any questions concerning the fee requirements, please contact the License Fee and Debt Collection Branch at (301) 415-6096.
If you have ariy questions, please contact me at (301) 415-7904 or Mr. John Lubinski at (301) 415-7868.
Sincerely, l
John P. Jankovich, Sr. Engineer Materials Safety Branch Division of Industrial and Medical Nuclear Safety Office of Nuclear Material Safety And Safeguards
Enclosure:
As stated cc w/ encl: SKimberley, LFDCB Distribution:
f IMNS r/f SSD-98-99 NE01 v
SSD File # NR-1032-D-101-S DOCUMENT NAME: H:\\SSDFILES\\ LETTERS \\N1032101. CMP To receive a copy of this document, indicate in the box: "C' = Copy without attachtnent' inclosure "E" = Copy with attachrnent/ enclosure
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l NAME JJankovich/jj /T[
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. REGISTRY OF RADIOAC1IVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (AMENDMENT OF PAGE 1 OF 7, December 21, 1998)
NO,.:'NR-1032-D-101-S
.DATE: October 24, 1997 PAGE 1 OF 7
-DEVICE TYPE: Transmission Line Source Housing MODEL:
Tre.nsACT DISTRIBUTOR:
Elscint, Inc.
22 Paris' Avenue Rockleigh, NJ 07647-2605 MANUFACTURER:
Elscint, Ltd.
PB 550, Haifa 31004 Israel SEALED SOURCE MODEL DESIGNATION:
North American Scientific Model MED3604 ISOTOPE:
MAXIMUM ACTIVITY:
Gadolinium-153 300 millicuries (11.1 Gbq)
LEAK TEST FREOUENCY:
6 Months PRINCIPAL USE:
(B) Medical Radiography CUSTOM DEVICE:
.. YES X
NO
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t REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE l
NO,:. NR-1032-D-101-S DATE: October 24, 1997 PAGE 2 OF 7 DEVICE TYPE:
Transmission Line Source Housing i
l' DESCRIPTION:
1 l
The Transact is intended for use with the Cardial gamma camera, j
and contains 300 millicuries per source housing.
Two source housings are usually installed on each Cardial gamma camera.
The source housing is designed to hold a sealed source installed l
by the user, and is manufactured and dist 'buted as an accessory i
device not containing radioactive materia The outside l
dimensions of the device are 36 x 120 x 47s mm (1.42 x 4.72 x
- 18.70 inches).
It is constructed of aluminum and steel, with i
lead shielding.
i The source rod is mounted in a cavity on a rotating rod within a l
lead shield /collimator.
The source is exposed (shutter opened) l by rotating the rod so that the source faces the collimator slit.
This rotating rod is mounted on a solenoid.
In case of a power l
' failure or interrupt, a spring mechanism rotates the rod back to the closed position.
The source can also be returned to the l
closed position by use of a manual lever on the end of the device.
A yellow LED on the gantry and the open position of the manual lever indicate that the source'is in the open position.
An unlit LED and the closed position of the manual lever (when the lever i
is not visible in the lever window) indicates that the source is in the closed position.
The thin fan-shaped beam is collimated such that the beam angle in the fan plane and with the shutter open, at 30 cm (11.81 inches) from the collimator slit is approximately 20 degrees.
l Source replacement will be approximately-yearly.
During source removal and installation, the shipping container that the source is shipped from the source manufacturer in is screwed to the g
l source cavity of the source housing.
The source, mounted in its metal holder, is pushed from the shipping container into the device.
The alignment of the shipping container and the source housing prevents any bending of the source during the installation process.
1 The device is portable to the extent that it can be detached from the gantry by the operator for secure storage when not in use.
The source remains in the source housing at all times, including storage.
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l REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE l
{
HQ 1 NR-1032-D-101-S DATE: October 24, 1997 PAGE 3 OF 7 DEVICE TYPE:
Transmission Line Source Housing DIAGRAM:
See attachments 1 and 2.
1 LAR,ELING:
The outside cover of each source housing will contain three labels.
The labels are made of Lexan attached to the source l
housing by Mac-Tac adhesive.
The labels contain the following l
l information:
Label 1:
l
- the words " Warning: Radioactive Material Enclosed"
- radiation trefoil symbol
- Gd-153-
- activity l
- date of manufacture (mm/dd/yy)
Label 2:
- distributor name f
- model number and serial number of device Label 3, attached next to the manual on/off lever:
- the words
- CAUTION: RADIATION IS ON WHEN RED TIP IS VISIBLE" CONDITIONS OF NORMAL USE:
i The source housing will be used as an accessory installed on a scintillation camera system in a clinical environment of a l
nuclear medicine imaging facility, and may be removed from the camera system when not in use for storage.
The source housing is l
intended for use only.in. clean medical (benign) environments.
The device should not be subjected to conditions exceeding those specified by the ANSI 77C64444 rating for source performance.
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PROTOTYPE TESTING:
The manufacturer reports that the source housing passed shutter testing that simulated approximately 18 years of use; passed MIL-STD-810D, Method 514.2 Procedure 1, for vibration caused by
. transportation; and passed drop testing from typical mounting height.
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REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE NO,: NR-1032-D-101-S DATE: October 24, 1997 PAGE 4 OF 7 DEVICE TYPE:
Transmission Line Source Housing PROTOTYPE TESTING (cont. ) :
No bend test was performed on the source rod, due to the fact that the source should not experience bending during use, installation, and removal.
During use, the source remains in a rod source holder and does not leave the source housing.
During l
installation, the shipping. container that the source is shipped from the source manufacturer in is screwed to the source cavity of the source housing.
The source, mounted in its metal holder, is pushed from the rigid shipping container into the source housing.
The alignment of the shipping container and the source l
housing prevents any bending of the source during the installation process.
The source housing itself is rigid, preventing bending of the source within the source housing.
EXTERNAL RADIATION LEVELS:
The following are the dose rates reported by the manufacturer, using a 300 millicurie (11 1 GBq) Gd-153 source.
Max. Radiation Level (mrem /hr)/(uSv/hr)
Distance (cm/in)
Shutter open*
Shutter closed contact
<6.0/0.060
<0.08/0.0008 30/11.81
<4.0/0.040
<0.04/0.0004 100/39.37
<0.5/0.005
<0.02/0.0002
- values are for collimator plane.
Since the beam is highly collimated, the values outside the collimator plane would be i
equal to the shutter closed values.
The manufacturer reports that for a 300 millicurie (11.1 GBq) source, a typical source exchange, lasting approximately 10 seconds, would result in an exposure of less than 0.027 mrem (0.00027 uSv) to the hands, with a typical exposure nearer to 0.006 mrem (0.00006 uSv).
A typical patient procedure (assuming 15 minutes), two 300 mci (11.1 GBq) sources, and considering only the contribution from the Transact source housing), would result in a patient exposure of less than 4.2 mrem /hr (0.042 usv/hr) at 30 cm (11.81 inches),
with a patient dose less than 2.15 mrem (0.0215 uSv).
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l REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES l
SAFETY EVALUATION OF DEVICE 1
NO.: NR-1032-D-101-S DATE: October 24, 1997 EAGE 5 OF 7 DEVICE TYPE:
Transmission Line Source Housing l
OUALITY ASSURANCE AND CONTROL-l l
The manufacturer states that the source housings are designed and manufactured in accordance with the ISO 9001 standard.
1.9
'iQC procedures include:
- An initial inspection of incoming materials to ensure that all parts are manufactured according to the standard drawings.
- Before shipment, each source h'ousing is tested as follows:
Radiation levels:
measurements are m"de to ensure that radiation level measurements with shutter in the closed position are within specification limits, Shutter reliability:
tested to 1080 cycles with sources without failure, the equivalent of approximately one year's work.
Note that the sources are usually replaced on a yearly basis, and inspection and maintenance will be performed on the source housing at that time.
Power failure:
check to ensure that the fail safe function operates properly.
- Upon initial source loading and subsequent source exchanges, the opening of the source-shipping container will be wipe tested.
This testing is in lieu of wipe testing of the source proper; due to loading procedures, the source is not directly accessible for wipe testing.
- Upon initial receipt and installation of the source housings and initial loading of the source, radiation level measurements are made to verify that they are within specification limits, and the shutter is tested for 180 cycles.
- After each source exchange, the shutter mechanism will be tested for correct operation in accordance with procedures that the manufacturer will provide to the user.
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REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE l
NO,: NR-1032-D-101-S DATE: October 24, 1997 PAGE 6 OF 7 l
l DEVICE TYPE:
Transmission Line Source Housing l
LIMITATIONS AND/OR OTHER CONSIDERATIONS OF USE:
l
- The source housing shall be serviced, and initially l
installed, by Elscint, or other persons specifically licensed by the NRC or an Agreement State to perform such activities.
- The source housing shall be distributed only to persons l
authorized by Section 35.11 of 10 CFR Part 35, or an equivalent Agreement State regulation.
- REVIEWER NOTE: Administrative procedures are required for safe operation and maintenance of the source housing, for source exchange, and for the control, installation, removal, and storage of the source housings as the source housings are designed to allow installation on and removal from the gantry for storage.
- REVIEWER NOTE: Administrative procedures are required to ensure that after each source exchange, the shutter mechanism will be tested for correct operation in accordance with procedures that the manufacturer will provide to the user.
- REVIEWER NOTE: Administrative procedures are required to ensure that upon initial source loading and subsequent source exchanges, the opening of the source-shipping container will be wipe tested.
This testing is in lieu of wipe testing of the source proper; due to loading procedures, the source is not directly accessible for wipe testing.
- The source housing shall be leak tested at intervals not to exceed 6 months using technignes capable of detecting 0.005 microcurie (185 Bq) of removable contamination.
i
- Handling, storage, use, transfer, and disposal:
To be determined by the licensing authority.
- This registration sheet and the information contained within j
the references shall not be changed without the written l,
consent of the NRC.
i l
l REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE NO,: NR-1032-D-101-S DATE: October 24, 1997 PAGE 7 OF 7 i
l DEVICE TYPE:
Transmission Line Source Housing I
SAFETY ANALYSIS
SUMMARY
Based on our review of the information and test data cited below, we conclude that the Elscint Model Transact line source housing l
is acceptable for licensing purposes as specified in this certificate.
l Furthermore, we conclude that the Model Transact line source housing would be expected to maintain its integrity for normal conditions of use and accidental conditions which might occur during uses specified in this certificate.
REFERENCES:
The following supporting documents for the Model Transact transmission line source housing are hereby incorporated by reference and are made a part of this registry document.
- Elscint, Inc. application' dated March 15, 1996, with enclosures thereto.
- Elscint, Inc. letters dated September 26, 1997, June 12, 1997, June 10, 1997, October 17, 1996, and August 5,
- 1996, with enclosures thereto.
- Elscint, Inc.
facsimiles dated October 23, 1997, September 30, 1997, July 23, 1997, July 6, 1997, March 12, 1997, and August 2, 1996, with enclosures thereto.
- Elscint, Israel facsimile dated June 18, 1997, with enclosures thereto.
ISSUING AGENCY:
U.S. Nuclear Regulatory Commission Date:
October 24. 1997 Reviewer:
- dd I
'Je%
Mic ele L. Burge5s 7
i Date:
October 24. 1997 Concurrence: /
Steven L.
Baggett l
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REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE h NR-1032-D-101-S DATE: October 24, 1997 ATTACHMENT 1 r
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