ML20198D277
| ML20198D277 | |
| Person / Time | |
|---|---|
| Issue date: | 08/10/1998 |
| From: | Steven Baggett, John Lubinski NRC |
| To: | |
| Shared Package | |
| ML20138M147 | List: |
| References | |
| SSD, NUDOCS 9812230054 | |
| Download: ML20198D277 (11) | |
Text
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t REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE i
NO.: NR-1049-D-101-S DATE: Aug. 10, 1998 PAGE 1 OF 8 DEVICE TYPE: Attenuation Correction Transmission Scan Box l
l
- MODEL: 2180897 l
l DISTRIBUTOR: GE Medical Systems j 3000 N. Grandview Blvd., W-641 Waukesha, WI 53188 i
l MANUFACTURER: DBA Systems, Inc.
1200 South Woody Burke Road Melbourne, FL 32902-0550 1
- SEALED SOURCE MODEL DESIGNATION: DuPont RadioPharmacueticals
! NES8423 l-l l
ISOTOPE: MAXIMUM ACTIVITY:
Gadolinium-153 500 millicuries (18.5 GBq) i l
l l
- i. LEAK TEST FREOUENCY: 6 months l
' PRINCIPAL USE: (V) General Medical Use t
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CUSTOM DEVICE: YES X NO t
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REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE NO,: NR-1049-D-101-S DATE: PAGE 2 OF 8 Aug. 10, 1998 DEVICE TYPE: Attenuation Correction Transmission Scan Box DESCRIPTION:
The box consists of a gadolinium-153 line source placed in a lead '
collimator, two lead shielded parking positions (one at each end of travel of the source), a motor and mechanisms for moving the collimator. The collimator consists of the gadolinium rod
' resting in a lead trough with a 4.3 mm (0.17 in) thick bottom, and sides that are 2.4 mm (0.09 in) thick. The trough is bonded with epoxy inside a lead top cover for an additional 2.2 mm (0.09 in) of shielding. The top of this cover has a recessed
~ channel in it for placement of filter strips. The entire lead assembly is epoxied in an aluminum housing for structural j strength and protection. The ends of the housing have' access l holes for the source to be loaded by the supplier. The access l holes are then sealed with 2.8 mm (0.11 in) thick lead plugs and bonded.with epoxy into place.
l The radioactive line source is placed in a lead collimator (by the source manufacturer), which covers the source on all sides except for one; a 2 mm (0.08 in) by 4 mm (0.16 in) rectangular slot allows radiation to escape in only one direction with minimal scatter. This collimator is bonded into an aluminum housings with epoxy. A filter is bonded with epoxy over the l slot. . Removable strips, are attached by two screws, one at each end, in front of beam opening to attenuate the radiation to a l desired activity. After the source has decayed for one half-life, this filter can be removed by service personnel to bring the beam intensity back to its original value without replacing the source.
The entire assembly is enclosed entirely in a 2 mm (0.08 in) thick aluminum' cover, held together by eight screws. Overall dimensions of the device are 584.5 mm (23.01 in) in length, 381.5 mm (15.02 in) in width, and 68.5 mm (2.70 in) in height.
Neither the source nor drive mechanism are accessible during normal operation, l
L A low-power motor drives the source assembly along two rails by a i timing belt connected to one end of the collimator. Another l timing belt, connected to the other end of the collimator, drives the position display unit moving a millimeter scale behind a window in the cover. Motion of the source is under the control of a circuit board, which controls moving the source from one parking position to the other, at a requested speed, on command from a computer. Speeds can range from sweep times of 3 seconds t
l REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE NO,: NR-1049-D-101-S DATE: Aug. 10, 1998 PAGE 3 OF 8 DEVICE TYPE: Attenuation Correction Transmission Scan Box DESCRIPTION: (cont.)
(patient scans) to 1000 seconds (calibration). The line source moves away from the gantry during one transmission acquisition, then toward the gantry on the next, along two parallel guides which are 225 mm (8.86 in) long and 210 mm (8.27 in) apart. If the source does not reach its position in the expected time, drive control is dropped and the source is retracted by a return spring mechanism.
At both ends of the scanning range there are shielded parking positions. The source is shielded when it is positioned in one of the two lead shielded park positions. It is exposed for human use or calibrations when it is moved out of a shielded park position.
Three light emitting diodes (LED) indicate whether the source is shielded (parked) or exposed. Each parking position is indicated by one of two green LEDs on the scan box. A yellow LED indicates that the source is exposed between these two positions. In addition, a mechanical indicator, driven by the source as it travels, displays the source position in millimeters. The display is white when the source is beneath a lead shutter in a park position and yellow when it is exposed.
In the event that power is lost or an emergency stop is initiated, a torsional spring mechanism returns the source to the park position nearest to the gantry. All motion of the collimator may be mechanically locked to a parked and shielded position by i
pressing the lock button. The design does not allow the source position to be locked when it is not in park. This mechanical lock can only be unlocked by use of a key.
l During transport or service of the source, a 4 mm (0.16 in) lead I cap is used to cover the collimator to prevent the release of radiation.
Two Scan Boxes (model 2180897 devices) are used in conjunction
! with the GE Optima Nuclear Medicine System Tomography Gantry to provide the means to measure the attenuation effects of the anatomy on patient images. The scan boxes, each placed across from one detector to be on opposite sides of the patient during scanning, are permanently mounted.by two bolts to the Optima gantry and rotate with the gantry during tomographic scans. Each source moves axially to the rotation of
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. .: i REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE ;
1 4
NO, NR-1049-D-101-S DATE: Aug. 10, 1998 PAGE 4 OF 8 l DEVICE TYPE: Attenuation Correction Transmission Scan Box !
DESCRIPTION: (cont.)
the gantry when a tomographic scan is being acquired.
Counterweights are added to the gantry to balance the weight of the scan boxes. The option (two model 2180897 scan boxes plus counterweight) weighs approximately 50 kg (110.23 lb). The 2180506 model number is the model number for this Attenuation Correction Option.
The scan boxes are powered from the Optima gantry and do not have their own separate on-off mechanism. Installation of a box consists of attaching the box with two bolts to the rotational ring of the gantry, and connecting the scan box power cord connector to a receptacle on the gantry. Power is supplied to.the ACTSB when the gantry is turned on.
LABELING:
A label, supplied by the source manufacturer, is affixed to the source housing and contains the radiation trefoil symbol, l isotope, source model number, lot number, activity, and date of assay. The source manufacturer will also supply a redundant label which will be attached to the outside of the scan box by GE Medical Systems personnel.
A device identification label is affixed to the outside of the device contains the manufacturer's name, distributor's name, model number, serial number, and power ratings.
DIAGRAM:
I See attachments 1 - 3.
CONDITIONS OF NORMAL USE:
i i
These devices are used by physicians and other health care professionals in controlled clinical conditions at temperatures between 13 and 27 C (55.4 - 80.6 F).
! Patients will-be near the device when undergoing a scan l procedure. Operators will be near the device during setup and acquisition.
The suggested working life of these devices is 10 years.
According to GE, typical patient workload is 8 patients per day.
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i REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE NO.- NR-1049-D-101-S DATE: kag. 10, 1998 PAGE 5 OF 8 DEVICE TYPE: Attenuation Correction Transmission Scan Box PROTOTYPE TESTING:
Evaluation of the Attenuation Correction option was performed at l
two clinical sites for 14 and 11 months. During this evaluation period, typical patient throughput of 5-10 patients per day was conducted on each Optima (approximately 2000 patients each).
Over 300 transmission scans (uEing these Attenuation correction boxes) were conducted. No hardware failure of the boxes were reported. This information is indicative of typical use and vibration that the scan boxes would be subjected to.
GE Medical Systems performed a drop test on a prototype unit.
The drop height was one meter (39.4 in), which is twice the normal height of the device during installation or removal. GE reported that there was no increase in radiation levels around the device or source holder after the drop. The source mechanism operation was verified after the drop: the source holder retracted back into the shielded position, after being pulled into the scan area.
In addition, four prototypes units were subjected to a reliability test. GE reported that the devices operated flawlessly for 4,160,000 scans. In a 10 year lifetime, GE estimates that, 640,000 scans would expected assuming 250 working days / year, and 8 patients / day with 32 scans per patients.
l EXTERNAL RADIATION LEVELS:
The following maximum dose rates were reported by GE Medical for two Model 2180897 Scan Boxes, each containing e 200 mci Gd-153 source (filter removed) as part of the Model 2180506 Option:
In-Beam Distance Exposure Shielded i
(inches) (cm) (mR/hr) (pSv/hr) (mR/hr) (pSv/hr) l 1.97 5 9.6 96.0 0.020 0.20 11.81 30 7.2 72.0 0.012 0.12 39.37 100 0.008 0.08 0.008 0.08 Note: 100 cm is in direct line of the beam but is shielded by detector. The air gap between source and detector is 60 cm.
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE NO,: NR-1049-D-101-S DATE : Aug. 10, 1998 PAGE 6 OF 8
~
DEVICE' TYPE: Att'enuation Correction-Transmission Scan Box EXTERNAL RADIATION LEVELS: (cont.)
Not in Beam Distance Exposure Shielded (inches) (cm) (mR/hr) (pSv/hr) (mR/hr) (pSv/hr) 1.97 5 0.49 4.9 0.027 0.27 11.81 30 0.023 0.23 0.012 0.12 39.37 100 0.008 0.08 0.008~ 0.08 Note: 100 cm is in direct line of the beam but is shielded by detector. The air gap between source and detector is 60 cm.
A typical patient:will receive a dose approximately equal to that measured at 30 cm from two scan boxes. GE estimates the dose to
~
i the patient for a 64-view tomographic acquisition with a 500 mci i source will be 0.345 mR (3.4 5 pSv) .
OUALITY ASSURANCE AND CONTROL:
GE. maintains a quality assurance and control program which has been deemed acceptable for licensing purposes by the NRC. A copy
- of their. program is on file with NRC.
All products are manufactured and tested in accordance with the FDA's Good Manufacturing Practices, ISO 9001 and EN46001 standards.
DBA Systems assembles and tests each box. GE conducts final
- acceptance on each box verifying overall scan box performance, operation of the safety features, and presence of product labels.
GE Medical Systems is audited four times a year (1 internal and 3 external). The audit. includes review processes, procedures and documentation'for design, manufacturing, sourcing, material acceptance, complaints, product changes, quality policy,
[ management reviews and personnel training.
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REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE.
NO,: NR-1049-D-101-S DATE: Aug. 10, 1998 PAGE 7 OF 8 DEVICE TYPE: Attenuation Correction Transmission Scan Box LIMITATIONS AND/OR OTHER CONSIDERATIONS OF USE:
- The device shall be distributed to persons specifically
. licensed by the NRC or an Agreement State.
- Handling, storage, use, transfer, and disposal: To be determined by.the licensing authority. j
- The device shall be leak tested at intervals not to exceed .
6 months using techniques capable of detecting l 0.005 f microcurie - (185 Bq) of removable contamination.
- The sources are to be loaded by the source manufacturer into I
.the assembled collimator.
- The following! services are to be performed only by persons specifically : licensed to do so by the NRC or an Agreement State: radiation surveys, repair, source replacement, removal or changing of-filter, relocation, training, and installation.
- The following services may be performed by the user: leak testing, moving the whole optima system short distances'with
-scanners attached provided the sealed source is locked in shieldied position, and any other maintainence tasks which do not affect the shielding or movement of the sealed source.
- This registration sheet and'the information contained within the references shall not be changed without written consent u of the NRC.
i SAFETY ANALYSIS
SUMMARY
Based on'the review of the Model 2180897 Attenuation Correction l.
' Transmission Scan ~ Box Option, we conclude that the device is j; acceptable for' specific licensing purposes.
I Furthermore, we conclude that the device would be expected to maintain.it's containment integrity for normal conditions of use
'and. accidental-conditions which might occur during uses specified
'in this certificate.
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REGISTRY OF RADIOACTIVE SEALED SOURCES-AND DEVICES
-SAFETY EVALUATION OF DEVICE l
NO.: NR-1049-D-101-S DATE: Aug. 10, 1998 PAGE 8 OF 8
,.. DEVICE TYPE: Attenuation Correction Transmission Scan Box
REFERENCES:
]
The following-supporting documents for the Model 218089"/ ,
Attenuation Correction Transmission Scan Box are hereby incorporated by reference and are made a part of this registry l document. j i
- GE Medical Systems' application dated March 28, 1997, with enclosures thereto. l
- GE Medical Systems' letters dated March 19, 1998, May.8, 1998, June 12, 1998,. July 9, 1998, July 17, 1998, July 21, )
1998, and July 29, 1998, with enclosures.thereto.
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ISSUING AGENCY:
U.S. Nuclear Regulatory Commission
//
Date: Aug. 10, 1998- Reviewer: . hLubinski
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Date: Aug. 10, 1998 Concurrence: /' ~{/,'/y <
l Steven L. Baggett l
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REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE NO.: NR-1049-D-101-S DATE: Aug. 10, 1998 ATTACHMENT 1 fi'l p
! Transmission Line Source $g; NES XXXX Radionucude: Od-153 i:oj f l ;=, Activity: 100(.X ber: MCI$)D00000(-XXX Date: XX/XX jjg o cc 2
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Device Identification Label
- f. (Affixed to outside of scan box)
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE NO.- NR-1049-D-101-S DATE: Aug. 10, 1998 ATTACHMENT 2 i
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l Attenuation Correction Transmission Scan Box (GE Medical Model 2180897)
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE .
& NR-1049-D-101-S DATE: Aug. 10, 1998 ATTACHMENT 3
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- s Shown above are two Scan Boxes (model 2180897) and associated equipment as part of the Attenuation Correction Option (model 2180506) for the GE Optima Tomography Gantry i
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e pw UNITED STATES NUCLEAR REGULATORY COMMISSION f WASHINGTON, D.c. 20665-0001
,g* August 10, 1998 Glenn Stricklin GE Medical Systems 3000 N. Grandview Blvd., W-641 Waukesha, WI 53188
Dear Mr. Stricklin:
This is in reference to your affidavits dated March 17.1998, May 7,1998, and July 10,1998, and the letters dated July 17,1998, July 21,1998, and July 29,1998, in which you requested that pages, or portions of pages from the Optima AC program document, AS, A10; B7, B45, 847-B52, B54-857, B59-B65, B87-885, B87-B88; C5-C25; E2; F2-F7, F10-F11, and F14 of GE Medical Systems' (GEMS) application dated March 28,1997, as well as, the information attached in response to item 8 (GE Procedure OPT-856 and DHR0100) of GEMS' letter dated March 19,1998, be withheld from public disclosure pursuant to 10 CFR 2.790. A non-proprietary version of the Optima AC proprietary pages has been submitted for placement in the Public Document Room. GE Medical Systems' submitted multiple letters in response to the NRC's repeated questioning that its documents and attachments contained information which is not proprietary. See enclosure for NRC corresponder,ce.
The information is being withheld from public disclosure for the following reasons:
- a. Information that discloses a process, method, or apparatus, including supporting data and analyses, where prevention ofits use by GEMS' competitors without license from GEMS constitutes a competitive economic advantage over other companies:
- b. Information which, if used by a competitor, would reduce his expenditure of resources or improve his competitive position in the design, manufacture, shipment, installation, assurance or quality, or licensing of a similar product.
We have reviewed your application and the material in accordance with the requirements of 10 CFR 2.790 and, on the basis of GE Medical Systems' statements, have determined that the information sought to be withheld contains trade secrets or proprietary commercial information regarding specifications of the design and fabrication process.
Therefore, we have determined that the pages listed above will be withheld from public disclosure pursuant to 10 CFR 2.790(b)(5) and Section 103(b) of the Atomic Energy Act of i 1954, as amended.
g Withhol+g from public inspection shall not affect the right, if any, of persons properly and directly ../,1cerned to inspect the documents. If the need arises, we may send copies of this information to our consultants working in this area. We will, of course, ensure that the consultants have signed the appropriate agreements for handling proprietary information.
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G. Stricklin If the basis for withholding this information from public inspection should change in the future, such that the information could then be made available for public inspection, you should promptly notify the NRC. You also should understand that the NRC may have cause to review this determination in the future, for example, if the scope of a Freedom of Information Act request includes your information. In all review situations, if the NRC needs additional information from you or makes a determination adverse to the above, you will be notified in advance of any public disclosure.
Sincerely, Steven L. Baggett, Deputy Branch Chief Materials Safety Branch Division of Industrial and Medical Nuclear Safety Office of Nuclear Material Safety and Safeguards
Enclosure:
NRC Corrywondence with GE Medical Systems' Concerning Withholding of Proprietary Information Distribution: . , _ . _ .
jj, IMNS r/f RS80-97-30Pg, NE01 UL l DOCUMENT NAME: H:\ERIC\ MISC \GE.AFF
- See Previous Concurrence To receive a copy of this document, indicate in the boa: "C' = Copy without attachment / enclosure "E* = Copy with attachment / enclosure "N' = No copy OFFICE MSB lE MSB E OGC E l
NAME ECompton
- SBaggett
- MPSiemien
- DATE 07/23/98 07/23/98 07/24/98 OFFICIAL RECORD COPY
e
'e G. Stricklin additionalinformation from you or makes a determination adverse to the above, you will be notified in advance of any public disclosure.
Sincerely, Steven L. Baggett, Deputy Branch Chief Materials Safety Brangh Division of Industrial and Medical Nuclear Safety Office of Nuclear Material Safety and Safeguards
Enclosure:
NRC Correspondence with GE Medical Systems' Concerning Withholding of Proprietary information Distribution:
IMNS r/f SSD-97-30 NE01 DOCUMENT NAME: H:\ERIC\ MISC \GE.AFF Ts recel'ce a copy of this docurnent, indicate in the box: "C' = Copy without attachment / enclosure 'E" = Copy with attachment / enclosure 'N' = No copy OFFICE MSB y MSB ,f t C OGC C NAME ECompton O SBaggettg/g & MPSiemien h)%/
DATE 07/2f/98 07/,93 /95 ' f 07/ Ay/98 OFFICIAL RECORD COPY L- -
_ _ _ _ _ _ _ _ _ _ _ _ _ . _ i
a Enclosure 1: NRC Correspondence with GE Medical Systems' Concerning Withholding of Proprietary Information i
i CORRESPONDENCE DATE DESCRIPTION GE Medical Systems' 3/28/97 contained pages marked confidential application NRC letter (Eric Compton) 2/23/98 indicated need for affidavit in accordance with 10 CFR 2.790 GE letter (Thomas Demke) 3/19/98 contained affidavit of Glenn Stricklin dated 3/17/98 NRC letter (Steven Baggett) 4/9/98 indicated to GE that affidavit did not comply with 10 CFR 2.790 GE letter (Thomas Demke) 5/8/98 contained revised affidavit of Glenn Stricklin dated 5/7/98 NRC letter (John Lubinski) 5/29/98 requested additionalinformation concerning application GE letter (Bill Ray) 6/12/98 contained revised version of QA/QC procedures referenced in affidavit NRC letter (John Lubinski) 7/1/98 indicated to GE that much of the information was not proprietary '
GE letter (Bill Ray) 7/9/98 GE changed status of much of the material, provided updated affidavit of Glenn Stricklin dated 7/10/98 GE letter (Bill Ray) 7/17/98 Per phone conversation with John Lubinski 7/17/98, modified status of additional documents GE letter (Bill Ray) 7/21/98 Per phone conversation with Eric Compton 7/20/98, cleared up discrepancies of previous letter GE letter (Bill Ray) 7/29/98 Contained fax from UBA Systems indicating their Quality Policy non-proprietary
V ; .,
August 10, 1998 Thom s A. Demks, D.D.S.
GE Medical Systems, Nuclear Medicine 3000 N. Grandview Blvd., W-641 Waukesha, WI 53188
Dear Dr. Demke:
Based on the information and test data submitted in your application dated March 28,1997, we conclude the Model 2180897 Attenuation Correction Transmission Scan Box is acceptable for licensing purposes in accordance with the conditions of the enclosed registration certificate (NR 1049-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 annuet 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 any questions, please contact me at (301) 415-5799 ur Mr. John Lubinski at (301) 415-7868.
Sincerely,
/s/
Eric B. Compton, Engineering Aide Materials Safety Branch Division ofIndustrial and Medical Nuclear Safety Office of Nuclear Material Safety and Safeguards
Enclosure:
As stated cc w/ encl: SKimberley, LFDCB Distribution: yy7 ,, a IMNS r/f SSD-97-30 CNE011 . .a SSD File # NR-1049-D-101-S #'"" '
DOCUMENT NAME: H:\ERIC\COMPLTR\N1049101.WPD To recoh,e a copy of this document. Indicate in the boa: "C" = Copy without attachment / enclosure "E" = Copy with attachment / enclosure "N" = No copy OFFICE MSB. b MSB () (# l l NAME ECompton g JLubinski DATE 07/JS /98 07/(v/98 OFFICIAL RECORD COPY nnown w
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REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE NO.: NR-1049-D-101-S DATE: Aug. 10, 1998 PAGE 1 OF 8 DEVICE TYPE: Attenuation Correction Transmission Scan Box MODEL: 2180897 DISTRIBUTOR:_ GE Medical Systems 3000 N. Grandview Blvd., W-641 Waukesha, WI 53188 MANUFACTURER: DBA Systems, Inc.
1200 South Woody Burke Road Melbourne, FL 32902-0550 SEALED SOURCE MODEL DESIGNATION: DuPont RadioPharmacueticals NES8423 ISOTOPE: MAXIMUM ACTIVITY:
Gadolinium-153 500 millicuries (18.5 GBq)
LEAK TEST FREOUENCY: 6 months PRINCIPAL USE: (V) General Medical Use CUSTOM DEVICE: YES X NO
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REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE NO,- NR-1049-D-101-S DATE: PAGE 2 OF 8 Aug. 10, 1998 l DEVICE TYPE: Attenuation Correction Transmission Scan Box 1 1
DESCRIPTION:
The box consists of a gadolinium-153 line source placed in a lead collimator, two lead shielded parking positions (one at each end of travel of the source), a motor and mechanisms for moving the collimator. The collimator consists of the gadolinium rod I resting in a lead trough with a 4.3 mm (0.17 in) thick bottom, I and sides that are 2.4 mm (0.09 in) thick. The trough is bonded with epoxy inside a lead top cover for an additional 2.2 mm (0.09 in) of shielding. The top of this cover has a recessed ,
channel in it for placement of filter strips. The entire lead j assembly is epoxied in an aluminum housing for structural strength and protection. The ends of the housing have access holes for the source to be loaded by the supplier. The access j holes are then sealed with 2.8 mm (0.11 in) thick lead plugs and bonded with epoxy into place.
The radioactive line source is placed in a lead collimator (by ,
the source manufacturer), which covers the source on all sides !
except for one; a 2 mm (0.08 in) by 4 mm (0.16 in) rectangular slot allows radiation to escape in only one direction with minimal scatter. This collimator is bonded into an aluminum housings with epoxy. A filter is bonded with epoxy over the slot. Removable strips, are attached by two screws, one at each end, in front of beam opening to attenuate the radiation to a desired activity. After the source has decayed for one half-life, this filter can be removed by service personnel to bring the beam intensity back to its original value without replacing the source.
The entire assembly is enclosed entirely in a 2 mm (0.08 in) thick aluminum cover, held together by eight screws. Overall dimensions of the device are 584.5 mm (23.01 in) in length, 381.5 mm (15.02 in) in width, and 68.5 mm (2.70 in) in height.
Neither the source nor drive mechanism are accessible during normal operation.
A low-power motor drives the source assembly along two rails by a timing belt connected to one end of the collimator. Another timing belt, connected to the other end of the collimator, drives the position display unit moving a millimeter scale behind a window in the cover. Motion of the source is under the control of a circuit board, which controls moving the source from one parking position to the other, at a requested speed, on command from a computer. Speeds can range from sweep times of 3 seconds
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REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE NO;; NR-1049-D-101-S DATE: Aug. 10, 1998 PAGE 3 OF 8 DEVICE TYPE: Attenuation Correction Transmission Scan Box DESCRIPTION: (cont.)
(patient scans) to 1000 seconds (calibration). The line source moves away from the gantry during one transmission acquisition, then toward the gantry on the next, along two parallel guids s which are 225 mm (8.86 in) long and 210 mm (8.27 in) apart. If 1 the source does not reach its position in the expected time, drive control is dropped and the source is retracted by a return spring mechanism.
At both ends of the scanning range there are shielded parking positions. The source is shielded when it is positioned in one of the two lead shielded park positions. It is exposed for human use or calibrations when it is moved out of a shielded park position. )
Three light emitting diodes (LED) indicate whether the source is shielded (parked) or exposed. Each parking position is indicated j
- by one of two green LEDs on the scan box. A yellow LED indicites that the source is exposed between these two positions. In addition, a mechanical indicator, driven by the source as it i travels, displays the source position in millimeters. The
. display is white when the source is beneath a lead shutter in a j park position and yellow when it is exposed.
In the' event that power is lost or an emergency stop is initiated, a torsional spring mechanism returns the source to the park: position nearest to the gantry. All motion of the collimator may be mechanically locked to a parked and shielded position by ,
pressing the lock button. The design does not allow the source i position to be locked _when it is act in park. This mechanical lock can only be unlocked by use of a key.
During transport or service of the source, a 4 mm (0.16 in) lead i cap is.used to cover the collimator to prevent the release of l l radiation.
Two Scan Boxes (model 2180897 devices) are used in conjunction with the GE Optima Nuclear Medicine System Tomography Gantry to provide the means to measure the &ttenuation effects of the
- anatomy on patient images. The scan boxes, each placed across from one detector to be un' opposite sides of the patient during scanning, are permanently mounted.by two bolts to the Optima gantry and rotate with the. gantry during tomographic scans. Each source moves axially to the rotation of f
e - - - ,
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE l 1
NO : NR-1049-D-iO1-S DATE: Aug. 10, 1998 PAGE 4 OF 8 l DEVICE TYPE: Attenuation Correction Transmission Scan Box i
DESCRIPTION: (cont.)
the gantry when a tomographic scan is being acquired.
Counterweights are added to the gantry to balance the weight of the scan boxes. The option (two model 2180897 scan boxes plus counterweight) weighs approximately 50 kg (110.23 lb). The 2180506 model number is the model number for this Attenuation Correction Option.
The scan boxes are powered from the Optima gantry and do not have their own separate on-off mechanism. Installation of a box consists of attaching the box with two bolts to the rotational ring of the gantry, and connecting the scan box power cord connector to a receptacle on the gantry. Power is supplied to the ACTSB when the gantry is turned on.
LABELING:
A label, supplied by the source manufacturer, is affixed to the source housing _and contains the radiation trefoil symbol, isotope, source model number, lot number, activity, and date of i . assay. The source manufacturer will also supply a redundant
[ label which will be attached to the outside of the scan box by GE Medical Systems personnel.
l A device identification label is affixed to the outside of the device contains the manufacturer's name, distributor's name, model number,' serial number, and power ratings.
DIAGRAM:
See attachments 1 -3.
CONDITIONS OF NORMAL USE:
l These devices are used by physicians and other health care professionals in controlled clinical conditions at temperatures between 13 and 27*C (55.4 - 80.6*F).
! Patients will be near'the device when undergoing a scan
. procedure. Operators will be near the device during setup and acquisition.
. The suggested working life of these devices is 10 years.
According to GE, typical patient workload is 8 patients per day.
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE NO.: NR-1049-D-101-S DATE: Aug. 10, 1998 PAGE 5 OF 8 DEVICE TYPE: Attenuation Correction Transmission Scan Box PROTOTYPE TESTING:
Evaluation of the Attenuation Correction option was performed at two clinical sites for 14 and 11 months. During this evaluation period, typical patient throughput of 5-10 patients per day was conducted on each Optima (approximately 2000 patients each).
Over 300 transmission scans (using these Attenuation Correction boxes) were conducted. No hardware failure of the boxes were reported. This information is indicative of typical use and vibration that the scan boxes would be subjected to.
GE Medical Systems performed a drop test on a prototype unit.
The drop height was one meter (39.4 in), which is twice the normal height of the device during installation or removal. GE l reported that there was no increase in radiation levels around the device or source holder after the drop. The source mechanism operation was verified after the drop: the source holder l retracted back into the shielded position, after being pulled into the scan area.
In addition, four prototypes units were subjected to a reliability test. GE reported that the devices operated flawlessly for 4,160,000 scans. In a 10 year lifetime, GE estimates that, 640,000 scans would expected assuming 250 working days / year, and 8 patients / day with 32 scans per patients.
l EXTERNAL RADIATION LEVELS:
The following maximum dose rates were reported by GE Medical for two Model 2180897 Scan Boxes, each containing a 200 mci Gd-153 source (filter removed) as part of the Model 2180506 Option:
i j In-Beam Distance Exposure Shielded (inches) (cm) (mR/hr) (psv/hr) (mR/hr) (pSv/hr) 1.97 5 9.6 96.0 0.020 0.20 11.81 30 7.2 72.0 0~.012 0.12 l
39.37 100 0.008 0.08 0.008 0.08 Note: 100 cm is in direct line of the beam but is shielded by detector. The air gap between source and detoctor is 60 cm.
i REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES l SAFETY EVALUATION OF DEVICE NO.: NR-1049-D-101-S DATE : Aug. 10, 1998 PAGE 6 OF 8 DEVICE TYPE: Attenuatic" Correction Transmission Scan Box EXTERNAL RADIATION LEVELS: (cont.)
Not in Beam Distance Exposure Shielded (inches) (cm) (mR/hr) (psv/hr) (mR/hr) (psv/hr) 1.97 5 0.49 4.9 0.027 0.27 11.81 30 0.023 0.23 0.012 0.12 39.37 100 0.008 0.08 0.008 0.08 Note: 100 cm is in direct line of the beam but is shielded by detector. The air gap between source and detector is 60 cm.
A typical patient will receive a dose approximately equal to that measured at 30 cm from two scan boxes. GE estimates the dose to the patient for a 64-view tomographic acquisition with a 500 mci source will be 0.345 mR (3.45 pSv).
OUALITY ASSURANCE AND CONTROL:
GE maintains a quality assurance and control program which has been deemed acceptable for licensing purposes by the NRC. A copy of their program is on file with NRC.
All products are manufactured and tested in accordance with the FDA's Good Manufacturing Practices, ISO 9001 and EN46001 standards.
DBA Systems assembles and tests each box. GE conducts final acceptance on each box verifying overall scan box performance, operation of the safety features, and presence of product labels.
GE Medical Systems is audited four times a year (1 internal and 3 external). The audit includes review processes, procedures and l
documentation for design, manufacturing, sourcing, materia]
acceptance, complaints, product changes, quality policy, management reviews and personnel training.
l
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE NO,: NR-1049-D-101-S DATE: Aug. 10, 1998 PAGE 7 OF 8 pEVICE TYPE: Attenuation Correction Transmission Scan Box LIMITATIONS AND/OR OTHER CONSIDERATIONS OF USE:
- The device shall be distributed to persons specifically licensed by the NRC or an Agreement State.
- Handling, storage, use, transfer, and disposal: To be determined by the licensing authority.
- The device shall be leak tested at intervals not to exceed 6 months using techniques capable of detecting 0.005 microcurie (185 Bq) of removable contamination.
- The sources are to be loaded by the source manufacturer into the assembled collimator.
- The following services are to be performed only by persons specifically licensed to do so by the NRC or an Agreement State: radiation surveys, repair, source replacement, removal or changing of filter, relocation, training, and installation.
- The following services may be performed by the user: leak testing, moving the whole Optima system short distances with scanners attached provided the sealed source is locked in shieldied position, and any other maintainence tasks which do not affect the shielding or movement of the sealed source.
- This registration sheet and the information contained within the references shall not be changed without written consent of the NRC.
SAFETY ANALYSIS
SUMMARY
Based on the review of the Model 2180897 Attenuation Correction Transmission Scan Box Option, we conclude that the device is acceptable for specific licensing purposes.
Furthermore, we conclude that the device would be expected to maintain it's containment integrity for normal conditions of use l and accidental conditions which might occur during uses specified l in this certificate.
_ . . . _ _ _ .m _ . . . _ . . _ _-. . _ . - - _ _ . _ . - . . ___ _. .._ . . . _ . _ _ . . . _
l REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES
' SAFETY EVALUATION.0F DEVICE NO.: NR-1049-D-101-S DATE: Aug. 10, 1998 PAGE 8 OF 8 DEVICE TYPE: Attenuation Correction' Transmission Scan Box
REFERENCES:
The following supporting documents'for-the Model 2180897 s Attenuation Correction Transmission Scan Box are hereby ;
incorporated by reference and are made a part of this registry !
document.
)
- GE Medical Sys'tems' application dated March 28, 1997, with l enclosures thereto.
- GE Medical Systems' letters dated March 19, 1998, May 8, 1998, June 12, 1998, July 9, 1998, July 17, 1998, July 21, 1998, and July 29, 1998, with enclosures thereto.
ISSUING AGENCY:
U.S. Nuclear Regulatory Commission
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9 Date: Aug. 10, 1998 Concurrence:
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REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE NO.: NR-1049-D-101-S DATE: Aug. 10, 1998 ATTACHMENT 1 lii .. g C ! Transmission Line Source 8
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REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES s SAFETY EVALUATION OF DEVICE HQ.,_;_ NR - 10 4 9 - D - 101 - S DATE: Aug. 10, 1998 ATTACHMENT 3
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l l g UNITED STATES f
NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20566-0001
\ + April 9, 1998 l l 1 l Glenn Stricklin
! GE Medical Systems 3000 N. Grandview Blvd., W-641 Waukesha, WI 53188
Dear Mr. Stricklin:
This is in reference t; the affidavit dated March 17,1998, in which you requested that pages I
- A10; B7,89, B15-B18,822-B88; C5-C25; E2; F2-F11 and F14 of the GE Medical Systems' l (GEMS) application dated March 28,1997, as well as, all information attached in response to item 8 (DBA's Manual of Quality Assurance Policies, and GE Procedure OPT-856 and l DHR0100) of GEMS' letter dated March 19,1998, for the GE Model 2180506 Attenuation I Correction Transmission Scan Box, be withheld from public disclosure pursuant to 10 CFR 2.790. i l
We have reviewed your application and the material in accordance with the requirements of ;
10 CFR 2.790 and, on the basis of GEMS' statements, have determined that portions of the l information sought to be withheld contains trade secrets or proprietary commercial information.
However, the staff, in consultation with the Office of General Counsel, has determined that your affidavit does not comply with 10 CFR 2.790(b)(4). An example affidavit is enclosed for your l reference. Please note the similarity of the wording in the example affidavit to the wording in 10 CFR 2.790.
Section 2.790(b)(1) of 10 CFR Part 2 requires that each supporting application be accompanied i by an affidavit that contains a full statement of the reasons on the basis of which it is claimed that the information should be withheld from public disclosure. The section further states that the Commission will consider whether the information is of a type customarily held in confidence l by the applicant. Please note that, in general, only that information which can not be obtained through observation or measurement of components or documentation obtainable by a member l
'thheld as proprietary material.
1 i
,__N of the puplic can beehl si shl98 p o b-l l In-eddsun,10 CFR 2. 90(b)(1)(ii) requires that a non-proprietary version be submitted, in preparing the non-proprietary version p! ace brackets around the material considered to be proprietary, and white out or black out the proprietary portions, leaving the non-proprietary i portions intact.
\
With regard to the diagrams and blueprints, information typically considered to be proprietary i
! includes information such as dimensional tolerances and specific manufacturing notes or details listed on the drawing. Any additiona Mformation on the drawings would be releasable. In order to address this, please identify the specific information on each drawing that GEMS' wishes to
.' be held as proprietag.4MF pp y A proprietary versiop{with the br:.ekets)/non-proprietary version (with the marked out information) land the new affidavit must be submitted prior to the staff making its final proprietary determination. In accordance with 10 CFR 2.790(c), the information sought to be withheld will be placed in the Commission's Public Document Room unless you provide the l
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G Stricklin -
2-1 A Commission with the requested information, or a request that the letter be withdrawn, within 30 (thirty) days of the date of this letter if you have any questions concerning this matter, please contact me at (301) 415-7273.
l j Sincerely, 1
l even L. Bagg , Deputy Branch Chief Materials Safety Branch Division of Industrial and Medical Nuclear Safety i Office of Nuclear Material Safety l and Safeguards i
Enclosure:
Example Affidavit l
l l
l 4
4 i
l G Stricklin Cony .. n with the requested inforniation, or a request that the letter be withdrawn, within 30 (thirty) days of the date of this letter if you have any questions concerning this matter, please contact me at (301) 415-7273.
Sincerely, (orig. signed by)
Steven L. Baggett, Deputy Branch Chief Materials Safety Branch ,
l Division of Industrial and Medical Nuclear Safety Office of Nuclear Material Safety and Safeguards
Enclosure:
Example Affidavit l
l Distribution:
IMNS r/f SSD-97-30 NE01 DOCUMENT NAME: H:\ERIC\ MISC \GE.ADF C " ""'" "'
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AFFIDAVIT I, David J. Rohan, being duly sworn, depose and state as follows:
(1) I am Project Manager, Plant r ww ./ Renewal Projects, General Electric Company ("GE*) and have been delegaand the function of reviewing the infonnation described in paragraph (2) which is sought to be withheld, and have been authorized to apply for its withholding.
(2) 'Ibe infbreation sought to be withheld is contained in the GE proprietary report NEDC-31984P, Generic Em4andons g General searic Boi#ng Water Remaer Arwer Uprure - Sapplement 2, dated October 1992.
(3) In making this application for withholding otpropnetary information of which it is the owner, GE relies upon the exemption from disclo:ure set forth in the Freedom ofInformation Act ("FOIA'),5 USC Sec. 552(b)(4), and the Trade Secrets Act,18 USC Sec.1905, and NRC regulations 10 CFR 9.17(a)(4),
2.790(a)(4), and 2.790(d)(1) for " trade secrets and commercial or fiamaM information obtained from a person and privileged or confidential" (Exemption 4). The material for which exemption from disclosure is here sought is all " confidential commercial information", and some portions also qualify under the narrower definition of " trade secret", within the meanings assigned to thoes terms for purposes of FOIA Exemption 4 in, respectively, Critical Mass Energy Proiect v. Nuclear Regulatory Commission. 975F24871 (DC Cir.1992), and Public N=a_ N=ahh haarch Gmun v.FDA.
704F2dl280 (DC Cir.1983).
(4) Some ===al== of categories of information which 6t into the definition of proprietary information are:
Information that di=h a process, method, or apparatus, including supportag data and analyses, where preventien of its use by General Electric's competitors without th from General Electric constitutes a Wdve economic advantage over other compames; b Information which,if used by a competitor, would reduce his expenditure of resources or improve his vldve position in the design, manufacture, shipment, ine=11mtian, assurance of quality, or theias of a nimilar product;
_ _ _ _ _ _ _ _ _ _ _ d
.H
- c. Information which reveals cost or price information, prod budget or its suppliers; levels, or coaunescial strategies of General Elect
- d. Informati<=
j which reveals aspects of past, present, or future General Electric customer-funded development plans and programs, commercial value to General Electric; l e. desirable Information which discloses poentable subject maner for w to obtain patent protection. I information sought to be withhe reasons set forth in both in canaidemt to be proprietary for the (4)a. and (4)b., .
(5) The information conndence. sought 103 withhe5 is being submitted to NRC in GE, and is in fact so gheld. Its initial <W neion a and the subsequent steps taken to prevent its unauthorized disclo to the best of my knowledge and belief, cons by GE, no public disclosure has been made, and it is not ava sources. All di=%res to third parties includmg any required transmittals to NRC, have been made, or must be made, punuant to regulatory in conn.or yivyi;s.iy agreements which provide for maintenance of the (6) Initial approval of proprietary treatment manager of the originating component, of a document is made by the the person most likely to be acquidnted industry knowledge.
with the value and sensitivity of the information in relation to
'need to know" basis. Access to such documents within OE is (7)
'Ihe procedure for approval of external release of such a da-t typ requires other equivalent review by the staff manager, project manager, principal scienti authority, by the manager of the cognizant marketing funceinaeffect, competitive (or his anddelegate),
determinatina and by the Legal Operation, for nachai designation. of the accuracy of the prcpietary Diocle-es outside GE are limited to regulatory bodies, cu*=nas, and potential customerA and their agents suppliers , , -,and l' and others with a legitimate need for the informa6ca, and then only accordance with appropriate regulaton provisions orproprietary agreemen una.vn hc 2
( information identified in parngraph (2) is cl=&d as proprietary henne it contains hilad results of analytical madele, methods and processen, including w* codes, which GE has developed, obtained NRC approval of,and applied to perfonn evaluations of the power uprate condition for the nWR.
The development and approval of the BWR transent and accident analysis
/ computer codes used in this analysis was achieved at a significant cost, on the
! , order of a millina dollars, to GE.
, 'Ihe dai,y-eiit of the evaluation process along with the interpretation and
[g-g i application of the analytical results is derived from the extensive experience i
daahw that caneihites a @ GE asset.
k6 V 9 Public disclosure of the information sought to be withheld is likely to cause L d (9) substantial harm to GE's competitive position and foreclose or reduce the i availability of profit-making opportunities. 'Ihe information is part of GE's a' comprehensive BWR safety and technology base, and its commercial value 7 extends beyond the original development cost. The value of the technology base goes beyond the extensive physical hhw and analytict.1 methodology and includes development of the expertise to determine and apply the appropriate evaluation process. In addition, the technology base includes the value derrved from providmg analyses done with NRC approved methods.
'Ibe research, development, engineering, analytical and NRC review costs comprise a substantial investment of time and money by GE.
'Ihe precise value of the expertise to devise an evaluation process and apply
, the correct analytical methodology is difficult to quantify, but it clearly is substantial.
GE's E-g63tive advantage willbe lost ifits competitors are able to use the results of the GB experience to normali= or verify their own process or if they are able to claim an equivalent understanding by demanerating that they can arrive at the Mme or similar conclusions.
The valos of this information to GE would be lost if the information were dieclamad to the public. Making such information available to competitors without their having been required to undertake a similar erpaaditure of resourees would unfairly provide competitors with a windfall, and deprive GE of the opportunity to exercise its competitive advantage to seek an adequate return on its large invemment in dwA,i es d these very valuable analytical tools.
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STATE OF CALIPORNIA ) \
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COUNTY OF SANTA CLARA ) ss:
David J. Robare, being duly sw That he has read the fongoing affidorn, deposes an and N 2 Jhe best of his knowledge infoavit and the m,
\
re true Executed at San Jose, , s California rmatina, and thibelief, day of NomER i
1993.
David J. Rotare 1
\
General Electric Company ..
Subscribed and sf sworn day of befort une thi / N b
1993.
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! * & *, UNITED STATES f j NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20555 0001
+ , , , , p May 29, 1998 Thomas A. Demke, D.D.S.
GE Medical Systems 3000 N. Grandview Blvd., W-641 Waukesha, WI 53188
Dear Dr. Demke:
This letter is in response to your letter dated March 19,1998, providing additional information in support of your application. However, in order to continue our evaluation of your application, the following still needs to be addressed:
- 1. The NRC relies substantially on prototype testing to verify that the device will remain operational when subjected to conditions associated with normal handling and use, and will maintain its containment integrity (e.g., no loss of byproduct material nor significant loss of shielding) with the necessary safety features remaining operable. Specifically, GE Medical Systems needs to demonstrate that the device will maintain its integrity ,
after being subjected to repeated cycling and likely impacts during use. '
Cycle testing must demonstrate that the device will remain operation after the expected number of cycles over the years of use of the device (stated as 10 years in your application). This can be accomplished by subjecting a prototype unit to the expected number of cycles a device may encounter during its usefullife.
GE Medical Systems may demonstrate the device will withstand likely impacts encountered during use. The device does not need to remain operational after the impact but there must not be a loss of radioactive material nor significant decrease in shielding. This can be accomplished by subjecting a prototype unit to multiple drops on to a hard surface from the height of the device during normal use.
- 2. Due to the location of the mechanical indicator, if the source holder were to become stuck or an LED were to fail there would be a tendency for the operator to look at this indicator by putting his or her body into the beam. Therefore, please provide an estimate of the dose an operator might receive based on the dose rates and length of time spent in the beam. In addition, provide justification for the location of the indicator and/or indicate what measures would be needed to remedy this problem (e.g. moving the location of the indicator, implementing administrative methods including surveying the area to determine if source is shielded).
- 3. Please describe the quality control functions (e.g., audits of DBA and/or inspections or products performed by GE Medical Systems) that will be implemented by GE Medical Systems to verify that DBA is manufacturing and distributing the products in accordance with GE's application.
Please note that we are stillin the process of evaluating your request that certain information be withheld from public disclosure. This issue will be addressed in a separate letter.
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l Please provide the requested information within thirty (30) days. If you have any questions, l please contact me at (301) 415-7868 or Mr. Eric Compton at (301) 415-5799.
I Sincerely, Wind cigned tw John W. Lubinski, Mechanical Engineer Materials Safety Branch Division of Industrial and Medical Nuclear Safety Office of Nuclear Material Safety and Safeguards Distribution:
IMNS r/f SSD-97-30 NE01 DOCUMENT NAME: H:\ERIC\COMPLTR\GEMED.DEF Ta receive a copy of thle document, Indicate in the box: "C* = Copy without attachment / enclosure "E" = Copy with attachment / enclosure *N* = No copy OFFICE MSB l(; MSB j M NAME ECompton (c JLubinhki DATE 05/u /98 05/27 /98 OFFICIAL RECORD COPY