ML20212G322
| ML20212G322 | |
| Person / Time | |
|---|---|
| Issue date: | 10/24/1997 |
| From: | Steven Baggett, Michele Burgess NRC |
| To: | |
| Shared Package | |
| ML20212G311 | List: |
| References | |
| SSD, NUDOCS 9711060137 | |
| Download: ML20212G322 (9) | |
Text
. ____ _ ____ - _ __---_ _
c 4.
i..
REGISTRY OF_ RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE' NO.: NR-1032-D-101-S DATE: October 24, 1997 PAGE 1 OF"7
-DEVICE TYPE:
Transmission Line Source Housing a
-MODEL:
Transact DISTRIBUTOR:
Elscint, Inc.
505 Main Street
-Hackensack, NJ 07601 MANUFACTURER:
Elscint, Ltd.
POB 550, Haifa 31004 Israel
-SEALED SOURCE MODEL DESIGNATION:
North American Scientific Model MED3604 ISOTOPJA MAXIMUM ACTIVITY:
Gadolinium-153 300 millicuries (11.1 GBq) p-
-LEAK TEST FREOUENCY:
6 Months PRINCIPAL USE:
(B) Medical Radiography
= CUSTOM DEVICE:
YES X
NO i
9711060137 971024 PDR RC t-
- IBSD '
PDR e-
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION-OF DEVICEE NO.: NR-1032-D-101-S DATE: October 24,'1997 PAGE 2 OF 7 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 manufactur'4 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 shie]d/co111mator.
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 the.t 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 contair2r 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, includir storage.
~
Dc REGISTRY OF--RADIOACTIVE SEALED SOURCES AND DEVICES-
-SAFETY EVALUATION OF DEVICE h iNR-1032-D-101-S DI.TE:. October 24,E1997 PAGE 3'OP 7 DEVICE TYPE:
Transmission Line Source-Housing DIAGRAM:
4 Sae1 attachments 1 and.2.
LABELING:
~
j The outside-cover of each= source housing will contain three Llabels.
The labels are made of;Lexan attached,to the source-housing by_Mac-Tac adnesive.
The labels"contain thu'following information -
LabelE1:
- the words "WarningsiRadioactive;Mathrial Enclosed" l
- -radiation trefoil symbol-
- -activity-
=
- date of manufacture (mm/dd/yy) i Label 2:
- distributor'name e model. number and serial number of device
-Label 3,1 attached next to the manual on/off lever:
- the words." CAUTION: RADIATION IS ON WHEN RED TIP IS VISIBLE" CONDITIONS OF NORMAL USE:
The source housing will be used as an accessory installed on a scintillation camera system in a_ clinical environment of'a-nuclear medicineLimaging facility, and;may be removed.from the-camera-systemLwhen;not-in usenfor storage.
The source housing >is.
Lintended for use only-in clean medical (benign) - environments.
The device should not-be subjected to conditions exceeding thoce specified byEthe' ANSI 77C64444-_ rating for source performance.
PROT 3 TYPE TESTING:
L
-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 paased drop testing from typical mounting s
height.
4 W
N
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 QEyICE 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 onen*
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 uSv/hr) at 30 cm (11.81 inches),
with a patient dose less than 2.15 mrem (0.0215 uSv).
i
~
,. 4 -
l i s >
y
^
~~
m_
p 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:- Trancmission Line SourceiHousing.
OUALITY ASSURANCE AND CONTROLr The manufacturer states that the source housings-are-designedLand' manufactured.in accordance with the ISO 9001 standard.. The-QA/QC l
procedures include:
- An initial inspection of incoming materials to ensure that L
all-parts are manufactured according-to-the standard-drawings.
- Before shipment, each source housing is tested as follows:
' Radiation levels:
measurements'are made 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 1of 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 andLaubsequent-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 ccycles.
- 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.-
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE NO,1 NR-1032-D-101-S DATE: October 24, 1997 PAGE 6 OF 7 DEVICE TYPE:
Transmission Lina 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 25, 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.
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 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 lineisource housing is acceptable for licensing, purposes as specified in this certificate.
i Furthermore, we conclude:that th'e 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 sourceLhousing are_hereby incorporated by
[
reference and are made a part of this. registry-document.
- Elscint, Inc._ application dated March 15,-1996, with enclosures thereto.
L
- 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-W s-Mic ele L. Burge5s Date:
October 24. 1997 Concurrence: - M M
Steven L.
Baggett
1 T
4 REGISTRY GE RADIOACTIVE' SEALED SOURCES AND DEVICES SAFETY. EVALUATION OF DEVICE h NR-1032-D-101-S
- DATE: October 24,-1997, ATTACHMENT 1
/-
/-
/
' g l
3 Source Closed
~
Source Opened r
3
(
O60 7Q* ' O s O
/
N i
i 1
i
_ _s I
s t
Ny
- ~
O O
O O
O
_3 C
O 0
ff s
w.- _.
y_
l Collimat Line Source in Opened and Closed Positioning Source Rod
$ 8 Inserting the Source Rod Into the Source Holder
RFGISTRY OF RADIOACTIVE SEALED SOURCCS AND DEVICES SAFETY EVALUATION OF DEVICE h t NR-2032-D-101-S DATE: October 24, 1997 ATTACHMEN'I' 2 fI/'/,
/\\
(
+(
/
/
xx L -
/,. /
ss i
//
\\\\
\\'
\\\\f
,I N;;
\\
, 9/
p i,6,9'
'N g/ N, f.
' 6,
/
\\
g
/
f sss p
y
/
/
N
/
je
/
Devices as mounted on frame L
... _ _