ML20211B063
| ML20211B063 | |
| Person / Time | |
|---|---|
| Issue date: | 08/23/1999 |
| From: | Jankovich J, Samson Lee NRC |
| To: | |
| Shared Package | |
| ML20211B049 | List: |
| References | |
| SSD, NUDOCS 9908240213 | |
| Download: ML20211B063 (19) | |
Text
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REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES )
SAFETY EVALUATION OF DEVICE F_Qi NR-0726-D-801-S DATE: August 23, 1999 PAGE: 1 OF 16 DEVICE TYPE: Brachytherapy HDR Remote Afterloader MODEL: GammaMed 12it, GammaMed 12i DISTRIBUTOR: Frank Barker Associates, Inc.
33 Jacksonville Road, Bldg. #1 Towaco, NJ 07082 I
l MANUFACTURER: Isotopen-Technik Dr. Sauerwein, GmbH Bergische Str. 16 D-5657 Haan, Germany I
SEALED SOURCE MODEL DESIGNATION: RTS Models 721, 724 i
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ISOTOPE: MAXIMUM ACTIVITY:
Iridium-192 12 curies (444 GBq) l Depleted Uranium 26 lbs. (12 kg) l l
LEAK TEST FREOUENCY: 6 months l
PRINCIPAL USE: (V) General Medical Use CUSTOM DEVICE: YES NO X 9908240213 990823 PDR RC
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REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE 1
l HQ1 NR-0726-D-801-S DATE: August 23, 1999 PAGE: 2 OF 16 DEVICE TYPE: Brachytherapy HDR Remote Afterloader DESCRIPTION:
The Model GammaMed 12it High Dose Rate ,(HDR) remote afterloading brachytherapy irradiator is a mobile unit designed for the controlled irradiation of cancerous tissue with a predetermined dose delivered directly to the affected tissue by placing the radioactive source inside the tumor. This is accomplished by moving either an RTS Model 721 or 724 capsule, through an applicator, which is inserted into the patient and through the tumor, to a series of preset incremental positions for specified dwell times. This provides a dose profile which can be customized to deliver maximum damage to the cancerous tissue with minimal damage to healthy tissue. The source used in the device contains a nominal activity of 10 curies (370 GBq), maximum activity of 12 curies (444 GBq), of iridium-192.
1 The unit contains 24 ports through which the source may be i sequentially passed in order to provide for irradiation at various locations within the patient, each with a unique dose l profile requirement. The unit may be preprogrammed to pass the source assembly through each port to which a source guide tube (SGT) and applicator are connected in any desired order.
However, the unit is equipped with a sensor which prevents the source from passing through any port which does not have a SGT connected. A typical treatment consists of entering the l treatment plan into the computer, connecting the SGTs to the appropriate channel, connecting the appropriate applicators to the SGTs, inserting the applicators into the patient and initiating the treatment sequence.
l The basic unit consists of a depleted uranium shield, a dummy and live source with identical dimensions, two source drive mechanisms (ona each for the live and dummy sources), an indexer which selects the appropriate port, source position limit switches and optical sensors, an emergency hand crank, a built-in Geiger-Muller radiation monitor, a control panel with associated
- computer, a backup battery, and associated electronics. The unit is mounted on a mobile trolley, measures 42" (1050 mm) long by 21" (520 mm) wide by 36" (900 mm) high, has a mass of 250 lbs l
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i REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE !
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HQ1 NR-0726-D-801-S DATE : August 23, 1999 PAGE: 3 OF 16 DEVICE TYPE: Brachytherapy HDR Remote Afterloader ;
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DESCRIPTION: (Cont'd)
(112 kg).
Security from unauthorized use of the device / source is provided by means of a mechanical / electrical key lock located on the control console.
Prior to actual treatment using the live source, the dummy source is automatically cycled through the channel which has been programmed for use in order to test for any obstructions, proper length of SGT/ applicator combination (SGT/ applicator combinations I must be a fixed length), and to verify that a SGT is correctly connected to the selected channel. The SGT/ applicator length is verified by attempting to extend the dummy source 0.4" (10 mm) past the maximum treatment position. If the drive motor does not encounter resistance due to the source reaching the end of the applicator, an interrupt is initiated, treatment is halted, and the error message " Probe Tube too long" is displayed at the control console. Likewise, if any of the other tests fail, a treatment interrupt is initiated a similar error message is generated at the control console. The operator must acknowledge these error messages at the control console prior to continuing ,
treatment or beginning any new treatments. Once the error I message has been acknowledged, treatment may be canceled or continued. If the treatment is continued, the unit will retest the channel that failed to ensure the fault has been corrected.
The dummy source can also be used to verify actual source position as compared to programmed source position. This may be accomplished either by fluoroscopy (during treatment) or by means of a special clear glass applicator through which the source can be viewed and which has markings that indicate relative source position. As an additional check, the actual position of the live source can also be viewed (remotely) using this adapter.
After the dummy source has been cycled through the selected channel the actual source goes through its preprogrammed sequence. If an obstruction is detected using the live source or if the SGT is not correctly connected or absent, a treatment interrupt will be initiated and an error message will be l
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REGISTRY OF RADIOACTIVE-SEALED SOURCES AND DEVICES l SAFETY EVALUATION OF DEVICE l
l HQ1 NR-0726-D-801-S DATE %umist 23, 1999 PAGE: 4 OF 16 DEVICE TYPE: Brachytherapy HDR Remote Afterloader DESCRIPTION: (Cont'd) generated at the control console. As with the dummy source, if an error is encountered, the-error message must be acknowledged prior to treatment being resumed.. If treatment is resumed, the unit will retest the channel using the dummy source prior to the live source being,sent out.
Source position is controlled by means of an incremental position encoder and several optical limit switches. Whenever the source is being extended to the distal end.of the applicator, the length of the source is measured using the limit' switches and encoder.
If the length of the source is not within 0.2" (5 mm) of the specified value (every source assembly should be the same length) ;
an emergency abort is initiated and an. error message is generated i at the control console. The length of~the live source as well as the dummy source is checked in this~ manner for each channel selected. Once the length of the source and the length of the SGT/ applicator combination are verified, the distal end of the applicator is used as the reference point for source position.
If at any time the source fails to be correctly positioned or an l emergency situation is encountered, the source may be retracted quickly by pressing any of the emergency retract buttons located on the trolley or control console. Additionally, each unit may ,
be interlocked to the treatment room door. Therefore, any time l the door would be opened, the source would automatically retract.
If at any time the source fails to completely retract under theae circumstances (source should retract within 5 seconds), an emergency hand crank (located on the GammaMed unit) may be used to manually retract the source. This emergency crank can only be used to retract the live source and cannot be used to extend either the live or dummy sources. If the emergency crank fails to retract the source, the operator may physically remove the SGT/ applicator containing the source from the patient and, using remote handling equipment (e.g. forceps), place the source in a storage container provided by the manufacturer.
The unit is mounted on a portable trolley which can be raised or lowered, depending on user requirements, by a hydraulic cylinder attached to a manual foot pump. The trolley has wheels for
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l REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES i SAFETY EVALUATION OF DEVICE I NR1 NR-0726-D-801-S DATE: Aufsst 23, 1999 PAGE: 5 OF 16 1
DEVICE TYPE: Brachytherapy HDR Remote Afterloader !
DESCRIPTION: (Cont'd) portability which can be locked for treatment. The trolley also houses the battery backup system. In case of a power failure, ;
the battery backup will supply enough power to retract the source and retain the treatment plan in memory. Treatment cannot be continued until AC power has been restored and battery voltage ;
has been restored to a level sufficient to perform a source retract. If at any time during treatment battery voltage drops below the value necessary to perform a source retract, the source l will be retracted and an error message will be generated.
The unit is remotely controlled at the control console. From this console the user may start treatment, interrupt or abort treatment by pressing either the INTERRUPT or EMERGENCY buttons (source will be retracted in either case), view the entire treatment plan and the current treatment being performed, and l view any error messages received. An interrupt or an emergency i abort.may either be initiated by the operator.or by the unit !
under certain circumstances. In either situation (operator or unit initiated) the result will be the same as for unit initiated interrupts and emergency aborts which are discussed below.
An interrupt occurs when the unit detects an unexpected situation that has interfered or may interfere with treatment and that is not considered an emergency situation. In most situations the operator is able to correct the situation and continue the treatment from the point where the interrupt occurred. An example of an interrupt would be if the unit detected an obstruction in a source guide tube or a loose source guide tube.
The unit would initiate an interrupt, return the source to the stored position, and notify the operator of the reason for the interrupt via a beep and message at the control console. Once the error has been corrected and the command to continue treatment is issued, the unit will attempt to continue the treatment using the dummy source. If no errors are detected, treatment will continue.
An emergency abort occurs when the unit detects a situation where treatment cannot continue and harm to the patient or unit is possible. Following an emergency abort, an emergency error
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l' REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION-OF DEVICE HQL NR-0726-D-801-S DATE: Auglst 23, 1999 PAGE: 6 OF 16 DEVICE TYPE: Brachytherapy HDR Remote Afterloader DESCRIPTION: (Cont'd) message screen will be displayed at the control console which indicates the reason for the. emergency abort, the time the error occurred, the channel selected, and the position of the source at the time the abort occurred. The treatment is canceled by the unit and not allowed to resume until the operator has reviewed and acknowledged the error message and reentered the treatment I plan. The operator is given two indications that an emergency abort has occurred. First, the source is driven back into the stored position at twice the normal speed; second, a beep is sounded at the control console and the emergency error message screen is automatically displayed. The operator may not bypass the emergency error message screen by initiating a reset of the l computer. Additionally, the error message is retained in memory I even if AC power is lost. Examples of an emergency situation would be if the sensed position of the source did not correspond to the calculated position or if the length of the source was measured to not be within specifications.
The treatment plan is stored in the control console as well as the computer. During treatment, each plan is compared for consistency. If any discrepancies in the treatment plans are found, the treatment is immediately halted and an error message is generated. Also during treatment, source dwell times are controlled by two independent clocks, one in the computer and the 1 other in the GammaMed unit. If the clocks differ by greater than I 0.2 seconds, the treatment is halted and an error message is l generated.
The control console contains one RADIATION WARNING light and the GammaMed unit contains two RADIATION WARNING lights (one on each side). The lights are controlled by a Geiger-Muller radiation monitor which is installed in the GammaMed unit. The lights are preprogrammed to illuminate whenever greater than approximately 0.3 rem /hr - (3 mSv/hr) is detected. This provides the user positive indication that the source is extended or secured as well as an indication that the source may not have fully retracted. This may be confirmed by the operator viewing the SGT (which is constructed of translucent material) to determine if the source cable is visible. If the radiation monitor detects l
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE' HQ1 NR-0726-D-801-S' DATE: August 23, 1999 PAGE: 7 OF 16 DEVICE TYPE: Brachytherapy HDR Remote Afterloader DFSCRIPTION: (Cont'd) levels greater than 0.3 rem /hr two seconds after a retract has been initiated, audible (continuous beeping) and visual (flashing lights) alarms will indicate this condition a'nd the error message
" radiation" will be displayed on the control console screen.
A printout is generated during each treatment which highlights the treatment performed. If any error messages are generated they will be included in the printout. With this printout and the record stored in the computer, the user will be able to determine the exact time the error occurred and the position and status of the source. This printout also can be used as a permanent record of the patients treatment.
A review of the treatment planning software is beyond the scope of this safety analysis. Software design and testing analysis is performed by the Food and Drug Administration for medical devices.
The GammaMed 121 is substantially the same as the GammaMed 12it.
The devices incorporate the same source drive mechanism, indexer, electronic control system, safety features, and interlocks. The only differences between the devices are:
- 1. physical appearance - the GammaMed 12it has an outer housing that affords greater protection of the shield and source to meet Type A transport packaging requirements.
- 2. the mechanisms for controlling height and movement of the head of the unit and the unit stand.
The GammaMed 12i was originally registered with the State of New York by Mick-Radio Nuclear Instruments and the GammaMed 12it was originally registered with NRC by RTS Technology, Inc. However, l Frank Barker Associates, Inc. has taken responsibility for l
distribution of the devices within the U.S. RTS will continue to supply the sources to the customers for the devices.
1 REGISTRY'OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF. DEVICE N_Qi NR-0726-D-801-S DATE: August 23, 1999 PAGE: 8 OF 16 DEVICE TYPE: Brachytherapy HDR Remote Afterloader
, t DESCRIPTION: (Cont'd)f 1 Cylindrical. transport containers,provided by the manufacturer (see: Attachment 4),Eare used. for transpor.tation and temporary storage of new or used seal'ed: sources'. ;During an installation process the'old sealed-source is removed"from the device and placed'into the transport--containeri while the.new source is taken out of the transport container and inserted it into the !
device. Two different ports (one.for the new source and'one for j the used source)'are joined;to a cylindrical Wolfram (tungsten i alloy) shield mass approximately4 2" (50 mm) in diameter and 2.6"
.(67-mm) high by stainless steel' channels (tubing). Each sealed source is-held in placeLby a lever. The interior of the container has 33 lbs ' (15 kg) of lead for additional shielding.
Overall dimensions.of<the container are approximately 6.2" (158 mm) in' diameter and 13.9" (354 mm) high. Total weight is approximately 55 lbs. (25 kg) . A handle is attached for hand carrying.
LABELING:
The Model 121 includes the following five labels:
- 1. The manufacturers identification label which is constructed of aluminum and contains the manufacturer's name, model nmdaer and ' serial number. It is mounted on the rear of the stand.
2 Two radiation labels, one is silk screened on each side of the stainless steel sleeve that covers the depleted uranium i shield. Each label-includes the word radioactive, the I ' radiation symbol, and the isotope and capacity of the device.
L 3.- A lexan label, attached to the rear of the device, that indicates the inclusion of 26 lbs. (12 kg) of depleted uranium and includes the name, address, and telephone number of.the' distributor.
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE NO: NR-0726-D-801-S DATE: Auglst 23, 1999 PAGE: 9 OF 16 DEVICE TYPE: Brachytherapy HDR Remote Afterloader LABELING (Cont'd):
- 4. A stainless steel source identification which is supplied with the source assembly. It is attached with adhesive on j top of the device. J The Model 121t includes the following five labels:
- 1. The manufacturers identification label which is constructed of aluminum and contains the manufacturer's name, model j number, serial number, isotope and capacity of the device, and Type A package identification. It is mounted on the rear of the device. )
2 Two radiation labels, one on each side of the device, ,
contain the word radioactive and the radiation symbol.
- 3. A lexan label that indicates the inclusion of 26 lbs. (12 kg) of depleted uranium and includes the name, address, and telephone number of the distributor. It is located on top of the device.
- 4. A stainless steel source identification which is supplied with the source assembly. It is attached with adhesive on ,
the side of the device. i The Transport Container bears:
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- 1. A metal identification plate,.on the side, that contains the I standard radiation symbol, isotope, maximum activity, total weight, serial number, and manufacturer's name.
- 2. A circular metal plate, on the top, with the same information.
DIAGRAM:
See Attachments 1-4.
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE JiQ;. NR-0726-D-801-S DATE: August 23, 1999 PAGE: 10 OF 16 DEVICE TYPE: Brachytherapy HDR Remote Afterloader CONDITIONS OF NORMAL USE:
The afterloaders-are. designed to be used in conditions typically associated with hospitals _and medical facilities for the treatment of cancerous tumors. Treatment is typically performed with device and patient located in the same room. Therefore, these environs would fit for human occupancy.
Frank Barker Associates claims the Model GammaMed 12it is designed to be easily transported from one location to another and that conditions of transport would be typical of those of other medical products. In support of this claim, Frank Barker Associates has submitted test procedures and results which indicate the unit has been subjected to and passed Type A package testing.
.The devices are not designed to be subjected to temperatures greater than 104*F (4 0*C) .
PROTOTYPE TESTING:
RTS tested a prototype unit of the GammaMed 12it to the requirements for a DOT specification 7A, Type A package. No reduction in the structural integrity or shielding efficiency of the unit was noted by RTS following the testing. However, some deformation of the package was noted as a result of the Free Drop, Corner Drop, Compression, and Penetration tests.
Frank Barker Associates claims that Model GammaMed 12i units have been in use in the U.S. since 1989 and other similar devices have been in use in the U.S. and the UK for more than 10 years prior with no major instances of a failure of the units reported.
Frank Barker Associates claims that a prototype GammaMed 12it, containing only dummy sources, has been shipped to various hospitals and trade shows around the U.S. for demonstration purposes for over a year with no reduction in operability and no damage to the unit except scratches.
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REGISTRY OF. RADIOACTIVE SEALED SOURCES AND DEVICES
, SAFETY ~ EVALUATION OF DEVICE 4
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HQ.;_ NR-0726-D-801-S DATEL August :23,' 1999 PAGE: 11 OF 16 DEVICE TYPE: Brachytherapy HDR Remote Afterloader PROTOTYPE TESTING (Cont'd):
Prototypes of the Modelsl721 and 724 source assemblies have received ANSI.N542-1977 classifications of 77C53312, been subjected,to a repetitive, tensile-force, cyclic test using a 13 lb~(58 N) load (approximately three times the maximum, load the Model:GammaMed 12it may exert) repeatedly' applied and released 100 times,fand have been.shown to withstand a tensile force of up to 30 lbs (133 N). . Additionally, a prototype Model 721 remained operational after being subjected to 30,000 complete operational
. cycles and a prototype Model 724 remained operational for up to 20,000 complete operational cycles.
EXTERNAL RADIATION LEVELS:
Frank Barker Associates reported the following dose rates for a Model GammaMed 12it when loaded with 12 curies of Iridium-192.
The dose. rates were extrapolated from. actual measurements of a GammaMed 12it. loaded with 9.6 curies (355 GBq) of Iridium-192.
Surface 10 cm (3.94") 20 cm (7.87") 1m (39.4")
Top 1. 9 (19)- 1.0(10) 0. 5 (5) < 0.1 (<1)
Right 1. 0 (10) - 0.5(5) 0.4 (4) <0.1 (< 1 )
Front <0.1 (<1) < 0.1 (<1 ) < 0.1 (<1 ) < 0.1 (<1)
Left 1.0(10) 0. 5 (5) 0.4 (4) 0.1 l
Rear 2.5(25) 1.0(10) 0.4 (4) < 0.1 (<1 ) l Bottom 0.4(4) 0. 3 (3) 0.1(1) < 0.1 (< 1 )
Dose rates are listed in mR/hr with-the pSv/hr in parentheses. Locations of measurements are with respect.to the outer housing of the device.
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n-REGISTRY OF RADIOACTIVE SEALED' SOURCES AND DEVICES
. SAFETY EVALUATION OF DEVICE HQ1 NR-0726-D-801-S' DATE: Augmt 23, 1999 PAGE: 12 OF 16 DEVICE' TYPE: Brachytherapy HDR Remote Afterloader EXTERNAL RADIATION LEVELS (Cont'd):
- Frank Barker Associates. reported the following dose rates for a Model GammaMed 121-.when loaded with 12' curies of Iridium-192.
The dose rates were extrapolated ~from_ actual measurements of a GammaMed 121: loaded with'11.2; curies (414. GBq) Rof Iridium-192.
Surface 5 cm ' (2 " ) 230 cm (11.8") 1m (39.4")
jgga 6.1(61) 1.7(17) 0.3(3) < 0.1 (<1)
Right 4.7(47) 1.7(17) >
0.2 (2) < 0.1 (<1 )
Front 1.4(14) 0.9(9) 0.2 (2) < 0.1 (<1)
Left 5.4(54) 1.7(17) 0.4 (4) <0.1 (<1)
Rear - 0.4 (4 ) 0.2 (2) <0.1(<1) <0.1(<1)
Bottom' 4.1(41) 1.3(13) 0.2 (2) < 0.1 (< 1 )
Dose rates are listed in mR/hr with the pSv/hr in parentheses.
'OUALITY ASSURANCE AND CONTROL: ,
The. devices are manufactured under the quality assurance program of Isotopen-Technik Dr. Sauerwein, GmbH in accordance with the requirements of the German government for devices containing radioactive-material.
In addition, Frank Barker Associates subjects each device to an incoming quality assurance program consisting of the following:
- General inspection of the device for completeness and shipping damage.
- Inspect the indexer for proper installation and operation.
Inspect the drive mechanisms for proper installation and
-operation.
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REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION CF DEVICE NO: NR-0726-D-801-S DATE: Auglst 23, 1999 PAGE: 13 OF 16 DEVICE TYPE: Brachytherapy HDR Remote Afterloader OUALITY ASSURANCE AND CONTROL (Cont'd):
Inspect the electronics for proper installation and operation.
Inspect the brake mechanism for proper operation, (
j Inspect the computer and associated hardware for proper operation. )
l Install the GammaMed program and verify that the program {
properly detects faults and that all safety features of the {
program are performed correctly. '
l Inspect the SGTs and applicators for proper length and i condition.
Perform a source exchange and check unit for normal operation.
LIMITATIONE AND/OR CONSIDERATION OF USE:
The Models GammaMed 12it and GammaMed 12i shall be distributed only to persons specifically licensed by the NRC or an Agreement State.
The devices shall not be subjected to temperatures greater than 104*F (40*C). J The devices shall be leak tested at intervals not to exceed 6 months using techniques capable of detecting the presence )
of 0.005 microcurie (185 Bq) of removable contamination. l
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- Handling, storage, use, transfer, and disposal are to be i determined by the licensing authority. In view that the l
sources used in this device exhibit high dose rates, the l sources should be handled only by experienced licensed
! personnel following the manufacturer's instructions.
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REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE EQ1 NR-0726-D-801-S DATE: Augtst 23, 1999 PAGE: 14 OF 16 DEVICE TYPE: Brachytherapy HDR Remote Afterloader LIMITATIONS AND/OR CONSIDERATION OF USE (Cont' d) :
The devices.shall be initially installed and tested for proper operation of all systems prior to any treatment of humans. Installation shall only be performed by Frank fj Barker Associates or persons specifically licensed by the I NRC or an Agreement State to install the devices.
The Models GammaMed 12it and GammaMed 12i afterloaders shall 1 only be used with RTS Models 721 and 724 source assemblies or with other source assemblies as specified in a registration certificate issued by the NRC or an Agreement State. l 1
- REVIEWER NOTE: The GammaMed 12it has been tested to Type A package requirements. However, the device may only be used at locations as listed on a license issued by NRC or an Agreement State. Following transport from one location to another, the device must be properly installed by persons )
specifically licensed by NRC or an Agreement State to install the devices at the new location.
- REVIEWER NOTE: The built-in radiation monitor is a redundant safety feature and is not deemed to meet the requirement for an independent room monitor or portable survey meter.
REVIEWER NOTE: Policy and Guidance Directive 86-4 should be followed when licensing this device.
- REVIEWER NOTE: The GammaMed 12i was originally registered with the State of New York by Mick-Radio Nuclear Instruments ,
and the GammaMed 12it was originally registered with NRC by l RTS Technology, Inc. However, Frank Barker Associates, Inc.
has taken responsibility for distribution of the devices within the U.S. RTS will continue to supply the sources to the customers for the devices.
This registration sheet and the information contained within the references shall not be changed without the written consent of the NRC.
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REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE NO: NR-0726-D-801-S DATE: Auglst 23, 1999 PAGE: 15 OF 16 DEVICE TYPE: Brachytherapy HDR Remote Afterloader LIMITATIONS AND/OR CONSIDERATION OF USE (Cont'd):
- REVIEWER NOTE: There are 18 units sold and still in use.
All service for these units, including source replacement, will be performed by MDS Nordion. Their address is 413 March Road, PO Box 13140, Kanata, Ontario Canada K2K 2B7.
SAFETY ANALYSIS
SUMMARY
- I Frank Barker-Associates, Inc. will no' longer distribute or service the Gamma products. As a distributor, no changes were 1 made to the product since the last amendment. l Based on our review of the information and test data cited below, that no major failure of either device has been reported, and that the Type A packaging of the GammaMed 12it provides additional protection to the exposure device, we conclude that the Model GammaMed 12it and GammaMed 12i are acceptable for licensing purposes.
Furthermore, we conclude that the devices would be expected to maintain their containment integrity for normal conditions of use which might occur during the uses specified in this registration sheet.
I REFERENCES :
The following supporting documents for the Model GammaMed 12it and GammaMed 12i afterloaders are hereby incorporated by reference and are made a part of this registry document:
- RTS technology, Inc. application dated Jrne 6, 1991, and subsequent letters dated August 28, 1992, January 19, 1993, September 9, 1993, and September 10, 1993, with enclosures thereto.
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REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES
-SAFETY' EVALUATION OF DEVICE HQJ,NR.07.26-D'-80bS. DATE: . August 23, 1999' PAGE: 16 OF 16 DEVICE TYPE: Brachytherapy HDR Remote A'fterloader
' REFERENCES (Cont' d) : 4
-* Frank Barker. Associates, Inc. letters dated June 2, 1995,
- May 8,'1995, May 10, 1995, July 28, 1994, July 8, 1994, November 11, 1993, and June 4, 1996, with enclosures thereto.
- Operator's Manual for the GammaMed 12it received from Frank.
Barker Associates on July 27, 1994.
- ' Frank Barker Associates, Inc. letter dated June 29, 1999 and August 12, 1999.
- Frank' Barker Associates,.Inc. facsimile dated August 4, 1999 and August 13,- 1999.
ISSUING' AGENCY:
)
l U.S. NUCLEAR REGULATORY COMMISSION '
~Date Anone M - looo Reviewer X' '~"!d' es .,
Seiffig J. Lee f
Date August 23, 1999 Concurrence P -
(/ Johd P. Jankovich l l
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1 REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES l SAFETY EVALUATION OF DEVICE l 1
l NO.: NR-0726-D-801-S DATE: August 23, 1999 ATTACHMENT 1
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August 23, 1999 Mr. Jeffrey A. Smith Vice President Frank Barker Associates, Inc.
33 Jacksonville Road, Bldg 1 Towaco, NJ 07082
Dear Mr. Smith:
This letter is in reference to your letter dated June 29,1999, requesting to transfer the registration certificate NR-726-D-101-S to inactive status. This certificate has been transferred to inactive status as you have requested. The registration number for the certificate has been changed. The new registration numberis NR-726-D-801-S.
Please review the registration certificate (copy enclosed) in its' entirety and notify us immediately if there are any errors or omissions.
If you have any questions call me at (301) 415-5787 or Dr. John Jankovich at (301) 415-7904.
. Sincerely,
/s/
Seung J. Lee, Mechanical Engineer Materials Safety and Inspection Branch Medical, Academic and Commercial Use Safety Branch Division of Industrial and Medical Nuclear Safety, NMSS
Enclosure:
As stated cc w/ encl: SKimberley, LFDCB Distribution: p MSB r/f NMSS r/f SSD-99-48 NE0k/
SSD File # NR-726-D-801-S DOCUMENT NAME: H:\SJL\NR726801. CMP T
- receive a copy of this document, indicate in the box: "C" = Copy without attachmentrenclosure "E" = Copy with attachment' enclosure "N" = No copy OFFICE MSIB lE MSIB 1. l 6 l l l NAME Slee <f1 JJankovichf f DATE 08/09/98 08/.23/98 Y J OFFICIAL RECORD COPY M .n 'i& W ~j (4
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l-i REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES l SAFETY EVALUATION OF DEVICE NO: NR-0726-D-801-S DATE: August 23, 1999 PAGE: 1 OF 16 DEVICE TYPE: Brachytherapy HDR Remote Afterloader MODEL: GammaMed 12it, GammaMed 12i DISTRIBUTOR: Frank Barker Associates, Inc.
33 Jacksonville Road, Bldg. #1 Towaco, NJ 07082 1
MANUFACTURER: Isotopen-Technik Dr. Sauerwein, GmbH Bergische Str. 16 D-5657 Haan, Germany SEALED SOURCE MODEL DESIGNATION: RTS Models 721, 724 ISOTOPE: MAXIMUM ACTIVITY:
Iridium-192 12 curies (444 GBq)
Depleted Uranium 26 lbs. (12 kg)
LEAK TEST FREOUENCY: 6 months l PRINCIPAL USE: (VT General Medical Use l t CUSTOM DEVICE: YES NO X n %Y 'Db u'& 1%y-
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE e
HQ1 NR-0726-D-801-S DATE: Aug2st 23,1999 PAGE: 2 OF 16 DEVICE TYPE: Brachytherapy HDR Remote Afterloader DESCRIPTION:
The Model GammaMed 12it High Dose Rate (HDR) remote afterloading brachytherapy irradiator is a mobile unit designed for the controlled irradiation of cancerous tissue with a predetermined dose delivered directly to the affected tissue by placing the radioactive source inside the tumor. This is accomplished by moving either an RTS Model 721 or 724 capsule, through an applicator, which is inserted into the patient and through the tumor, to a series of preset incremental positions for specified dwell times. This provides a dose profile which can be customized to deliver maximum damage to the cancerous tissue with minimal damage to healthy tissue. The source used in the device contains a nominal activity of 10 curies (370 GBq), maximum activity of 12 curies (444 GBq), of iridium-192.
The unit contains 24 ports through which the source may be sequentially passed in order to provide for irradiation at various. locations within the patient, each with a unique dose profile requirement. The unit may be preprogrammed to pass the source assembly through each port to which a source guide tube (SGT) and applicator are connected in any desired order.
However, the unit is equipped with a sensor which prevents the source from passing through any port which does not have a SGT connected. A typical treatment consists of entering the treatment plan into the computer, connecting the SGTs to the appropriate channel, connecting the appropriate applicators to the SGTs, inserting the applicators into the patient and initiating the treatment sequence.
The basic unit consists of a depleted uranium shield, a dummy and live source with identical dimensions, two source drive mechanisms (one each for the live and dummy sources), an indexer which selects the appropriate port, source position limit switches and optical sensors, an emergency hand crank, a built-in Geiger-MQller radiation monitor, a control panel with associated computer, a backup battery, and associated electronics. The unit is mounted on a mobile trolley, measures 42" (1050 mm) long by 21" (520 mm) wide by 36" (900 mm) high, has a mass of 250 lbs
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE NQ1 NR-0726-D-801-S DATE : Austst 23, 1999 PAGE: 3 OF 16 l
DEVICE TYPE: Brachytherapy HDR Remote Afterloader DESCRIPTION: (Cont'd)
(112 kg).
Security from unauthorized use of the device / source is provided by means of a mechanical / electrical key lock located on the control console.
Prior to actual treatment using the live source, the dummy source is automatically cycled through the channel which has been programmed for use in order to test for any obstructions, proper length of SGT/ applicator combination (SGT/ applicator combinations must be a fixed length), and to verify that a SGT is correctly connected to the selected channel. The SGT/ applicator length is verified by attempting to extend the dummy source 0.4" (10 mm) past the maximum treatment position. If the drive motor does not encounter resistance due to the source reaching the end of the applicator, an interrupt is initiated, treatment is halted, and the error message " Probe Tube too long" is displayed at the control console. Likewise, if any of the other tests fail, a treatment interrupt is initiated a similar error message is generated at the control console. The operator must acknowledge these erro messages at the control console prior to continuing treatment or beginning any new treatments. Once the error message has been acknowledged, treatment may be canceled or continued. If the treatment is continued, the unit will retest the channr1 that failed to ensure the fault has been corrected.
The dummy source can also be used to verify actual source position as compared to programmed source position. This may be accomplished either by fluoroscopy (during treatment) or by means of a special clear glass applicator through which the source can be viewed and which has markings that indicate relative source position. As an additional check, the actual position of the live source can also be viewed (remotely) using this adapter.
I Af ter the dar: y source has been cycled throunh the selected channel the actual source goes through its preprogrammed sequence. If an obstruction is detected using the live source or if the SGT is not correctly connected or absent, a treatment interrupt will be initiated and an error message will be
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE NO: NR-0726-D-801-S DATE %ugust 23, 1999 PAGE: 4 OF 16 DEVICE TYPE: Brachytherapy HDR Remote Afterloader DESCRIPTION: (Cont'd)
I generated at the control console. As with the dummy source, if {
an error is encountered, the error message must be acknowledged l prior to treatment being resumed. If treatment is resumed, the unit will retest the channel using the dummy source prior to the live source being sent out. I
. Source position is controlled by means of an incremental position {
encoder and several optical limit switches. Whenever the source
{
is being extended to the distal end of the applicator, the length of the source is measured using the limit switches and encoder.
If'the length of the source is not within 0.2" (5 nmt) of the '
specified value (every source assembly should be the same length) an emergency abort is initiated and an error message is generated at the control console. The length of the live source as well as the dummy source is checked in this manner for each channel selected. Once the length of the source and the length of the SGT/ applicator combination are verified,'the distal end of the applicator is used as the reference point for source position.
If at any time the source fails to be correctly positioned or an emergency situation is encountered, the source may be retracted ,
quickly by pressing any of the emergency retract buttons located on the trolley or control console. Additionally, each unit may be interlocked to the treatment room door. Therefore, any time the door would be opened, the source would automatically retract.
If at any time the source fails to completely retract under these circumstances (source should retract within 5 seconds), an emergency hand crank (located on the GammaMed unit) may be used to manually retract the source. This emergency crank can only be used to retract the live source and cannot be used to extend either the live or dummy sources. If the emergency crank fails to retract the-source, the operator may physically remove the SGT/ applicator.containing the source from the patient and, using remote handling equipment (e.g. forceps), place the source in a storage container provided by the manufacturer.
The unit is mounted on a portable trolley which can be raised or lowered, depending on user requirements, by a hydraulic cylinder attached to a manual foot pump. The trolley has wheels for
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE NO: NR-0726-D-801-S DATE: Augmt 23, 1999 PAGE: 5 OF 16 DEVICE TYPE: Brachytherapy HDR Remote Afterloader
' DESCRIPTION: (Cont'd) portability which can be locked for treatment. The trolley also houses the battery backup system. In case of a power failure, the battery backup will supply enough power to retract the source and retain the treatment plan in memory. Treatment cannot be continued until AC power has been restored and battery voltage has been restored to a level sufficient to perform a source retract. If at any time during treatment battery voltage drops below the value necessary to perform a source retract, the source will be retracted and an error message will be generated.
The unit is remotely controlled at the control console. From this console the user may start treatment, interrupt or abort treatment by pressing either the INTERRUPT or EMERGENCY buttons (source will be retracted in either case), view the entire treatment plan and the current treatment being performed, and view any error messages received. An interrupt or an emergency abort may either be initiated by the operator or by the unit under certain circumstances. In either situation (operator or unit initiated) the result will be the same as.for unit initiated interrupts and emergency aborts which are discussed below. I An interrupt occurs when the unit detects an unexpected situation that has interfered or may interfere with treatment and that is not considered an emergency situation. In most situations the '
operator is able to correct the situation and continue the treatment from the point where the interrupt occurred. An example of an interrupt would be if the unit detected an obstruction in a source guide tube or a loose source guide tube.
The unit would initiate an interrupt, return the source to the stored position, and notify the operator of the reason for the interrupt via a beep and message at the control console. Once the error has been corrected and the command to continue i treatment is issued, the unit will attempt to continue the I treatment using the dummy source. If no errors are detected, treatment will continue.
An emergency abort occurs when the unit detects a situation where treatment cannot continue and harm to the patient or unit is
-possible. Following an emergency abort, an emergency error-
r 9
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE NO: NR-0726-D-801-5 DATE: Atypst 23, 1999 PAGE: 6 OF 16 DEVICE TYPE: Brachytherapy HDR Remote Afterloader DESCRIPTION: (Cont'd) message screen will be displayed at the control console which indicates the reason for the emergency abort, the time the error occurred, the channel selected, and the position of the source at the' time-the abort occurred. The treatment is canceled by the unit and not allowed to resume until the operator has reviewed and acknowledged the error message and reentered the treatment plan. The operator is given two indications that an emergency abort has occurred. First, the source is driven back into the stored position at twice the normal speed; second, a beep is
- sounded at the control console and the emergency error message screen is automatically displayed. The operator may not bypass the emergency error message screen by initiating a reset of the computer. Additionally, the error message is retained in memory even if AC power is lost. Examples of an emergency situation would be if the sensed position of the source did not correspond to the calculated position or if the length of the source was measured to not be within specifications.
The treatment plan is stored in the control console as well as the computer. During treatment, each plan is compared for l consistency. If any discrepancies in the treatment plans are found, the treatment is immediately halted and an error message is generated. Also during treatment, source dwell times are controlled by two independent clocks, one in the computer and the other in the GammaMed unit. If the clocks differ by greater than 0.2 seconds, the treatment is halted and an error message is l generated.
The control console contains one RADIATION WARNING light and the GammaMed unit contains two RADIATION WARNING lights (one on each side). The lights are controlled by a Geiger-Muller radiation monitor which is installed in the GammaMed unit. The lights are preprogrammed to illuminate whenever greater than approximately
) '
O.3 rem /hr (3 mSv/hr) is detected. This provides the user positive indication that the source is extended or secured as well as an indication that the source may not have fully retracted. This may be confirmed by the operator viewing the SGT (which is constructed of translucent material) to determine .f the source cable is visible. If the radiation monitor detects I i
r W
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES
. SAFETY EVALUATION OF DEVICE
.N_Qi NR-0726-D-801-S DATE: August 23, l'999. PAGE: 7 OF 16 DEVICE TYPE: Brachytherapy HDR Remote Afterloader DESCRIPTION: (Cont'd).
levels greater than 0.3 rem /hr two seconds after a retract has been initiated, audible (continuous beeping) and visual (flashing lights) alarms will indicate this condition a'nd the error message
" radiation" will be displayed on the control console screen.
A printout is generated during each treatment which highlights the treatment performed. If any error messages are generated they will be included in the printout. With this printout and the record stored in the computer, the user will be able to determine the exact time the error occurred and the position and status of the source. This printout also can be used as a permanent record of the patients treatment.
A review of the treatment planning software is beyond the scope of this safety analysis. Software design and testing analysis is ;
performed by the Food and Drug Administration for medical '
devices.
The GammaMed 121 is substantially the same as the GammaMed 12it.
The devices incorporate the same source drive mechanism, indexer, electronic control system, safety features, and interlocks. The only differences between the devices are:
- 1. physical appearance - the GammaMed 12it has an outer housing that affords greater protection of the shield and source to meet Type A transport packaging requirements.
- 2. the mechanisms for controlling height and movement of the head of the-unit and the unit stand.
The GammaMed 121 was originally registered with the State of New York by Mick-Radio Nuclear Instruments and the GammaMed 12it was originally registered with NRC by RTS Technology, Inc. However, Frank Barker Associates, Inc. has taken responsibility for l distribution of the devices within the U.S. RTS will continue to i supply the sources to the customers for the devices. !
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE NO: NR-0726-D-801-S DATE: Auglst 23, 1999 PAGE: 8 OF 16 DEVICE TYPE: Brachytherapy HDR Remote Afterloader DESCRIPTION: (Cont'd)
Cylindrical transport containers provided by the manufacturer (see Attachment 4), are used for transportation and temporary storage of new or used sealed sources. During an installation process the old sealed source is removed from the device and placed into the transport container while the new source is taken out of the transport container and inserted it into the device. Two different ports (one for the new source and one for the used source) are joined to a cylindrical Wolfram (tungsten alloy) shield mass approximately 2" (50 mm) in diameter and 2.6" (67 mm) high by stainless steel channels (tubing). Each sealed source is held in place by a lever. The interior of the container has 33 lbs. (15 kg) of lead for additional shielding.
Overall dimensions of the container are approximately 6.2" (158 mm) in diameter and 13.9" (354 mm) high. Total weight is approximately 55 lbs. (25 kg). A handle is attached for hand carrying.
LABELING:
The Model 12i includes the following five labels:
- 1. The manufacturers identification label which is constructed of aluminum and contains the manufacturer's name, model number and serial number. It is mounted on the rear of the stand.
2 Two radiation labels, one is silk screened on each side of the stainless steel sleeve that covers the depleted uranium shield. Each label includes the word radioactive, the radiation symbol, and the isotope and capacity of the device.
- 3. A lexan label, attached to the rear of the device, that indicates the inclusion of 26 lbs. (12 kg) of depleted uranium and includes the name, address, and telephone number of the distributor.
n REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE NO: NR-0726-D-801-S DATE: Augist 23,~1999 PAGE: 9 OF 16 I
DEVICE TYPE: Brachytherapy HDR Remote Afterloader LABELING (Cont' d) :
- 4. A stainless steel source identification which is supplied with the_ source assembly. It is attached with adhesive on top of the device.
The Model 12it includes the following five labels:
- 1. The manufacturers identification label which is constructed of aluminum and contains the manufacturer's name, model number, serial number, isotope and capacity of the device, and Type A package identification. It is mounted on the rear of the device.
2 Two radiation labels, one on each side of the device, contain the word radioactive and the radiation symbol.
- 3. A lexan label that indicates the inclusion of 26 lbs. (12 kg) of depleted uranium and includes the name, address, and telephone number of the distributor. It is located on top of the device.
- 4. A stainless steel source identification which is supplied with the source assembly. It is attached with adhesive on the side of the device.
The Transport Container bears:
l
- 1. A metal identification plate, on the side, that contains the standard radiation symbol, isotope, maximum activity, total weight, serial number, and manuf acturer's name.
- 2. A circular metal plate, on the top, with the same information.
DIAGRAM:
See Attachments 1-4.
[.
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REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE NO:.NR-0726-D-801-S. DATE: August 23, 1999 PAGE: 10 OF 16 DEVICE TYPE: Brachytherapy HDR Remote Afterloader CONDITIONS OF NORMAL USE:
Therafterloaders are designed to be used in conditions typically associated with hospitals and medical facilities for the treatment of cancerous tumors. Treatment is typically performed with device and patient located in the same room. Therefore, these environs would fit for human occupancy.
Frank Barker Associates claims the Model GammaMed 12it is designed to be easily transported from one location to another and that conditions of transport would be typical of those of other medical products. In support of this claim, Frank Barker Associates has submitted test procedures and results which indicate the unit has been subjected to and passed Type A package testing.
The devices are not designed to be subjected to temperatures greater than 104"F (40 C) .
PROTOTYPE TESTING:
RTS tested a prototype unit of the GammaMed 12it to the requirements for a DOT specification 7A, Type A package. No reduction in the structural integrity or shielding efficiency of the unit was noted by RTS following the testing. However, some deformation of the package was noted as a result of the Free Drop, Corner Drop, Compression, and Penetration tests.
Frank Barker Associates claims that Model GammaMed 12i units have been in use in the U.S. since 1989 and other similar devices have been in use in the U.S. and the UK for more than 10 years prior with no major instances of a failure of the units reported.
Frank Barker Associates claims that a prototype GammaMed 12it, l containing only dummy sources, has been shipped to various hospitals and trade shows around the U.S. for demonstration purposes for over a year with no reduction in operability and no damage to.the unit except scratches.
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE NO: NR-0726-D-801-S DATE: Augmt 23, 1999 PAGE: 11 OF 16 DEVICE TYPE: Brachytherapy HDR Remote Afterloader PROTOTYPE TESTING (Cont'd):
Prototypes of the Models 721 and 724 source assemblies have received ANSI N542-1977 classifications of 77C53312, been subjected to a repetitive, tensile force, cyclic test using a 13 lb (58 N) load (approximately three times the maximum load the Model GammaMed 12it may exert) repeatedly applied and released 100 times, and have been shown to withstand a tensile force of up j to 30 lbs (133 N). Additionally, a prototype Model 721 remained i operational after being subjected to 30,000 complete operational cycles and a prototype Model 724 remained operational for up to 20,000 complete operational cycles.
EXTERNAL RADIATION LEVELS:
Frank Barker Associates reported the following dose rates for a Model GammaMed 12it when loaded with 12 curies of Iridium-192.
The dose rates were extrapolated from actual measurements of a GammaMed 12it loaded with 9.6 curies (355 GBq) of Iridium-192.
Surface 10 cm (3.94") 20 cm (7.87") 1m (39.4")
Top 1.9(19) 1.0(10) 0.5(5) < 0.1 ( <1 )
Right 1.0(10) 0.5(5) 0.4 (4 ) < 0.1 (<1)
Front <0.1 (<1) < 0.1 (<1) < 0.1 (<1 ) < 0.1 ( < 1 )
Left 1.0(10) 0.5(5) 0.4 (4) 0.1 Rear 2.5(25) 1.0(10) 0.4 (4) < 0.1 (<1 )
Bottom 0.4 (4) 0.3(3) 0.1 (1 ) < 0.1 (<1)
Dose rates are listed in mR/hr with the pSv/hr in parentheses. Locations of measurements are with respect to the outer housing of the device. ;
l
1 -
l i
l REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE i
NO: NR-0726-D-801-S DATE: Augist 23, 1999 PAGE: 12 OF 16 DEVICE TYPE: Brachytherapy HDR Remote Afterloader j EXTERNAL RADIATION LEVELS (Cont'd): l Frank Barker Associates reported the following dose rates for a Model GammaMed 12i when loaded with 12 curies of Iridium-192. '
The dose rates were extrapolated from actual measurements of a GammaMed 12i loaded with 11.2 curies (414 GBq) of Iridium-192.
Surface 5 cm (2") 30 cm (11.8") 1m (39.4")
Top 6.1(61) 1.7(17) 0.3(3) < 0.1 (<1 )
Right 4.7(47) 1.7(17) 0.2 (2) < 0.1 (<1 )
Front 1.4(14) 0.9(9) 0.2 (2) < 0.1 (<1) j Left 5.4(54) 1.7(17) 0.4 (4 ) < 0.1 (<1 )
Rear 0.4 (4) 0.2 (2) <0.1(<1) < 0.1 (<1 )
Bottom 4.1(41) 1.3(13) 0.2 (2) < 0.1 ( < 1 )
Dose rates are listed in mR/hr with the pSv/hr in parentheses.
OUALITY ASSURANCE AND CONTROL:
The devices are manufactured under the quality assurance program of Isotopen-Technik Dr. Sauerwein, GmbH in accordance with the requirements of the German government for devices containing radioactive material.
In addition, Frank Barker Associates subjects each device to an incoming quality assurance program consisting of the following:
- General inspection of the device for completeness and shipping damage.
Inspect the indexer for proper installation and operation.
I
- Inspect the drive mechanisms for proper installation and operation.
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES '
SAFETY EVALUATION OF DEVICE I
NO: NR-0726-D-801-S DATE: August 23, 1999 PAGE: 13 OF 16 I
DEVICE TYPE: Brachytherapy HDR Remote Afterloader i l
l OUALITY ASSURANCE AND CONTROL (Cont ' d) : l 1
Inspect the electronics for proper installation and operation.
i
- Inspect the brake mechanism for proper operation.
Inspect the computer and associated hardware for proper operation.
Install the GammaMed program and verify that the program properly detects faults and that all safety features of the program are performed correctly.
Inspect the SGTs and applicators for proper length and condition.
Perform a source exchange and check unit for normal l operation.
l LIMITATIONS AND/OR CONSIDERATION OF USE:
The Models GammaMed 12it and GammaMed 12i shall be distributed only to persons specifically licensed by the NRC or an Agreement State.
The devices shall not be subjected to temperatures greater than 104*F (40*C).
The devices shall be leak tested at intervals not to exceed 6 months using techniques capable of detecting the presence of 0.005 microcurie (185 Bq) of removable contamination.
- Handling, storage, use, transfer, and disposal are to be determined by the licensing authority. In view that the sources used in this device exhibit high dose rates, the sources should be handled only by experienced licensed personnel following the manufacturer's instructions.
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE hoi NR-0726-D-801-S DATE: Augtst 23, 1999 PAGE: 14 OF 16 DEVICE TYPE: Brachytherapy HDR Remote Afterloader LIMITATIONS AND/OR CONSIDERATION OF USE (Cont' d) :
The devices shall be initially installed and tested for proper operation of all systems prior to any treatment of humans. Installation shall only be performed by Frank Barker Associates or persons specifically licensed by the NRC or an Agreement State to install the devices.
The Models GammaMed 12it and GammaMed 12i afterloaders shall only be used with RTS Models 721 and 724 source assemblies or with other source assemblies as specified in a registration certificate issued by the NRC or an Agreement State.
REVIEWER NOTE: The GammaMed 12it has been tested to Type A package requirements. However, the device may only be used at locations as listed on a license issued by NRC or an Agreement State. Following transport from one location to another, the device must be properly installed by persons specifically licensed by NRC or an Agreement State to install the devices at the new location.
REVIEWER NOTE: The built-in radiation monitor is a redundant safety feature and is not deemed to meet the requirement for an independent room monitor or portable survey meter.
REVIEWER NOTE: Policy and Guidance Directive 86-4 should be followed when licensing this device.
REVIEWER NOTE: The GammaMed 12i was originally registered with the State of New York by Mick-Radio Nuclear Instruments l and the GammaMed 12it was originally registered with NRC by l RTS Technology, Inc. However, Frank Barker Associates, Inc.
has taken responsibility for distribution of the devices within the U.S. RTS will continue to supply the sources to the customers for the devices.
This registration sheet and the information contained within the references shall not be changed without the written consent of the NRC.
l I
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REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE NO: NR-0726-D-801-S DATE: Auslst 23, 1999 PAGE: 15 OF 16 pEVICE TYPE: Brachytherapy HDR Remote Afterloader LIMITATIONS AND/OR CONSIDERATION OF USE (Cont'd):
REVIEWER NOTE: There are 18 units sold and still in use.
All service for these units, including source replacement, will be performed by MDS Nordion. Their address is 413 March Road, PO Box 13140, Kanata, Ontario Canada K2K 2B7.
SAFETY ANALYSIS
SUMMARY
Frank Barker Associates, Inc. will no longer distribute or service the Gamma products. As a distributor, no changes were made to the product since the last amendment.
Based on our review of the information and test data cited below, that no major failure of either device has been reported, and that the Type A packaging of the GammaMed 12it provides additional protection to the exposure device, we conclude that I the Model GammaMed 12it and GammaMed 12i are acceptable for licensing purposes.
Furthermore, we conclude that the devices would be expected to maintain their containment integrity for normal conditions of use which might occur during the uses specified in this registration ,
sheet.
)
REFERENCES:
The following supporting documents for the Model GammaMed 12it and GammaMed 12i afterloaders are hereby incorporated by
- reference and are made a part of this registry document.
l RTS technology, Inc. application dated June 6, 1991, and l subsequent letters dated August 28, 1992, January 19, 1993, l
September 9, 1993, and September 10, 1993, with enclosures thereto.
l t
4 REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY. EVALUATION OF DEVICE D ,
NQl. NR-0726-D-801-S DATE: August 23, 1999 PAGE: 16 OF 16 DEVICE TYPE:: l Brachytherapy HLR Remote Afterloader RE FERENCES (Cont' d) :
- Frank Barker Associates, Inc. letters dated June 2, 1995, May 8, 1995, May'10, 1995, July 28, 1994, July 8, 1994, November 11, 1993, and June 4, 1996, with enclosures thereto.
.
- Operator's Manual for the:GammaMed 12it received from Frank Barker Associates on July 27. 1994.
6
- Frank Barker Associates, Inc. letter dated June 29, 1999 and
' August 12,_1999.
- Frank Barker Associates, Inc. facsimile dated August 4, 1999 and August 13, 1999.
ISSUING AGENCY:
U.S. NUCLEAR REGULATORY COMMISSION
'r Date 'Anonne 71 1400
~
-Reviewer 7[
'~
Sedng J. Lee
/ /
Date August 23, 1999 Concurrence P - '
(/ Joh'd P. Jankovich
4 REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE NO.: NR-0726-D-801-S DATE: August 23, 1999 ATTACHMENT 1
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August 23, 1999 Mr. Jeffrey A. Smith Vice President -
Frank Barker Associates, Inc. l 33 Jacksonville Road, Bldg 1 Towaco, NJ 07082 i
l
Dear Mr. Smith:
This letter is in reference to your letter dated June 29,1999, requesting to transfer the registration certificate NR-726-D-101-S to inactive status. This certificate has been transferred to inactive status as you have requested. The registration number for the certificate has been changed. The new registration number is NR-726-D-801-S.
Please review the registration certificate (copy enclosed) in its' entirety and notify us ,
immediately if there are any errors or omissions. I If you have any questions call me at (301) 415-5787 or Dr. John Jankovich at (301) 415-7904.
Sincerely,
/s/
Seung J. Lee, Mechanical Engineer Materials Safety and Inspection Branch Medical, Academic and Commercial Use Safety Branch Division of Industrial and Medical Nuclear Safety, NMSS
Enclosure:
As stated cc w/ encl: SKimberley, LFDCB Distribution: p MSB r/f NMSS r/f SSD-99-48 NE0V SSD File # NR-726-D-801-S DOCUMENT NAME: H:\SJL\NR726801. CMP T F receive a cop r of this document, indicate in the box: "C" a Copy without attachment / enclosure "E" = Copy with attachment / enclosure "N" = No copy OFFICE MSIB E MSIB 1, l (., '
l l l NAME Slee ef1 JJankovichf f DATE 08/09/98 08/A3/98 b d OFFICIAL RECORD COPY
/ ^,c??'/^ N fj2
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE NO: NR-0726-D-801-S DATE: August 23, 1999 PAGE: 1 OF 16 DEVICE TYPE: Brachytherapy HDR Remote Afterloader l
MODEL: GammaMed 12it, GammaMed 12i DISTRIBUTOR: Frank Barker Associates, Inc.
33 Jacksonville Road, Bldg. #1 Towaco, NJ 07082 l
1 MANUFACTURER : Isotopen-Technik Dr. Sauerwein, GmbH Bergische Str. 16 D-5657 Haan, Germany i
SEALED SOURCE MODEL DESIGNATION: RTS Models 721, 724 i
l ISOTOPE: MAXIMUM ACTIVITY:
Iridium-192 12 curies (444 GBq)
Depleted Uranium 26 lbs. (12 kg)
LEAK TEST FREOUENCY: 6 months PRINCIPAL USE: (V) General Medical Use i
CUSTOM DEVICE: YES NO X M % 054De>l,5 { ('-
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE EQ1 NR-0726-D-801-S DATE: Aus2st 23,1999 PAGE: 2 OF 16 DEVICE TYPE: Brachytherapy HDR Remote Afterloader DESCRIPTION:
The Model GammaMed 12it High Dose Rate (HDR) remote afterloading brachytherapy irradiator is a mobile unit designed for the controlled irradiation of cancerous tissue with a predetermined dose delivered directly to the affected tissue by placing the radioactive source inside the tumor. This is accomplished by moving either an RTS Model 721 or 724 capsule, through an applicator, which is inserted into the patient and through the tumor, to a series of preset incremental positions for specified dwell times. This provides a dose profile which can be customized to deliver maximum damage to the cancerous tissue with minimal damage to healthy tissue. The source used in the device contains a nominal activity of 10 curies (370 GBq), maximum activity of 12 curies (444 GBq) , of iridium-192.
The unit contains 24 ports through which the source may be sequentially passed in order to provide for irradiation at various locations within the patient, each with a unique dose profile requirement. The unit may be preprogrammed to pass the source assembly through each port to which a source guide tube (SGT) and applicator are connected in any desired order.
However, the unit is equipped with a sensor which prevents the source from passing through any port which does not have a SGT connected. A typical treatment consists of entering the l
treatment plan into the computer, connecting the SGTs to the appropriate channel, connecting the appropriate applicators to the SGTs, inserting the applicators into the patient and initiating the treatment sequence.
l.
l The basic unit consists of a depleted uranium shield, a dummy and
- live source with identical dimensions, two source drive mechanisms (one each for the live and dummy sources), an indexer which selects the apprcpriate port, source position limit switches and optical sensors, an emergency hand crank, a built-in Geiger-MQller radiation monitor, a control panel with associated computer, a backup battery, and associated electronics. The unit is mounted on a mobile trolley, measures 42" (1050 mm) long by 21" (520 mm) wide by 36" (900 mm) high, has a mass of 250 lbs i
l o
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE HQ1 NR-0726-D-801-S DATE: Austst 23, 1999 PAGE: 3 OF 16 DEVICE TYPE: Brachytherapy HDR Remote Afterloader DESCRIPTION: (Cont'd)
(112 kg)'.
Security from unauthorized use of the device / source is provided by means of a mechanical / electrical key lock located on the control console.
Prior to actual treatment using the live source, the dummy source is automatically cycled through the channel which has been programmed for use in order to test for any obstructions, proper length of SGT/ applicator combination (SGT/ applicator combinations must be a fixed length), and to verify that a SGT is correctly connected to the selected channel. The SGT/ applicator length is verified by attempting to extend the dummy source 0.4" (10 mm) past the maximum treatment position. If the drive motor does not encounter resistance due to the source reaching the end of the applicator, an interrupt is initiated, treatment is halted, and the error message " Probe Tube too long" is displayed at the control console. Likewise, if any of the other tests fail, a treatment interrupt is initiated a similar error message is generated at the-control console. The operator must acknowledge these error messages at the control console prior to continuing treatment or beginning any new treatments. Once the error message has been acknowledged, treatment may be canceled or continued. If the treatment is continued, the unit will retest the channel that failed to ensure the fault has been corrected.
The. dummy source can also be used to verify actual source position as compared to programmed source position. This may be accomplished either by fluoroscopy (during treatment) or by means of a special clear glass applicator through which the source can be viewed and which has markings that indicate relative source position. As an additional check, the actual position of the live source can also be viewed (remotely) using this adapter.
After the dummy source has been cycled through the selected channel the actual source goes through its preprogrammed sequence. If an obstruction is detected using the live source or if the SGT is not correctly connected or absent, a treatment interrupt will be initiated and an error message will be
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE HQ1 NR-0726-D-801-S DATE %uglst 23, 1999 PAGE: 4 OF 16 DEVICE TYPE: Brachytherapy HDR Remote Afterloader DESCRIPTION: (Cont'd) generated at the control console.- As with the dummy source, if an error is encountered, the error message must be acknowledged prior to treatment being resumed. If treatment is resumed, the unit will retest the channel using the dummy source prior to the live source being sent out.
Source position is controlled by means of an incremental position encoder and several optical limit switches. Whenever the source is being extended to the distal end of the applicator, the length of the source is measured using the limit switches and encoder.
If the length of the source is not within 0.2" (5 mm) of the specified value (every source assembly should be the same length) an emergency abort is initiated and an error message is generated at the control console. The length of the live source as well as the dummy source is checked in this manner for each channel selected. Once the length of the source and the length of the SGT/ applicator combination are verified, the distal end of the applicator is used as the reference point for source position.
If at any time the source fails to be correctly positioned or an emergency situation is encountered, the source may be retracted quickly by pressing any of the emergency retract buttons located on the trolley or control console. Additionally, each unit may be interlocked to the treatment room door. Therefore, any time the door would be opened, the source would automatically retract.
If at any time the source fails to completely retract under these circumstances (source should retract within 5 seconds), an emergency hand crank (located on the GammaMed unit) may be used to manually retract the source. This emergency crank can only be used to retract the live source and cannot be used to extend either the live or dummy sources. If the emergency crank fails to retract the source, the operator may physically remove the SGT/ applicator containing the source from the patient and, using remote handling equipment (e.g. forceps), place the source in a storage container provided by the manufacturer.
The unit is mounted on a portable trolley which can be raised or lowered, depending on user requirements, by a hydraulic cylinder attached to a manual foot pump. The trolley has wheels for l
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE NOi NR-0726-D-801-S DATE: Augist 23, 1999 PAGE: 5 OF 16 DEVICE TYPE: Brachytherapy HDR Remote Afterloader DESCRIPTION: - (Cont ' d) portability which can be locked for treatment. The trolley also houses the battery backup system. In case of a power failure, the battery backup will supply enough power to retract the source and retain the treatment plan in memory. Treatment cannot be continued until AC power has been restored and battery voltage has been restored to a level sufficient to perform a source retract. If at any time during treatment battery voltage drops i below the value necessary to perform a source retract, the source j will be retracted and an error message will be generated. "
The unit is remotely controlled at the control console. From this console the user may start treatment, interrupt or abort treatment by pressing either the INTERRUPT or EMERGENCY buttons (source will be retracted in either case), view the entire treatment plan and the current treatment being performed, and view any error messages received. Jb1 interrupt or an emergency abort may either be initiated by the operator or by the unit under certain circumstances. In either situation (operator or ,
unit initiated) the result will be the same as for unit initiated )
interrupts and emergency aborts which are discussed below.
)
An interrupt occurs when the unit detects an unexpected situation that has interfered or may interfere with treatment and that is not considered an emergency situation. In most situations the operator is able to correct the situation and continue the ;
treatment from the point where the interrupt occurred. An example of an interrupt would be if the unit detected an l
obstruction in a source guide tube or a loose source guide tube.
The unit would initiate an interrupt, return the source to the stored position, and notify the operator of the reason for the interrupt via a beep and message at the control console. Once the error has been corrected and the command to continue treatment is issued, the unit will attempt to continue the I
treatment using the dummy source. If no errors are detected, treatment will continue.
An emergency abort occurs when the unit detects a situation where treatment cannot continue and harm to the patient or unit is possible. Following an emergency abort, an emergency error
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE NQ1 NR-0726-D-801-S_ DATE: Augpst 23, 1999 PAGE: 6 OF 16 DEVICE TYPE: Brachytherapy HDR Remote Afterloader DESCRIPTION: (Cont'd) message screen will be displayed at the control console which indicates the reason for the emergency abort, the time the error occurred, the channel selected, and the position of the source at the time the abort, occurred. The treatment is canceled by the unit and not allowed to resume until the operator has reviewed and acknowledged the error message and reentered the treatment plan. The operator is given two indications that an emergency abort has occurred. First, the source is driven back into the stored position at twice the normal speed; second, a beep is sounded at the control console and the emergency error message screen is automatically displayed. The operator may not bypass the emergency error message screen by initiating a reset of the computer. Additionally, the error message is retained in memory even if AC power is lost. Examples of an emergency situation would be if the sensed position of the source did not correspond to the calculated position or if the length of the source was measured to not be within specifications.
The treatment plan is stored in the control console as well as the computer. During treatment, each plan is compared for consistency. If any discrepancies in the treatment plans are found, the treatment is immediately halted and an error message is generated. Also during treatment, source dwell times are controlled by two independent clocks, one in the computer and the other in the GammaMed unit. If the clocks differ by greater than 0.2 seconds, the treatment is halted and an error message is generated.
The control console contains one RADIATION WARNING light and the GammaMed unit contains two RADIATION WARNING lights (one on each side). The lights are controlled by a Geiger-MQller radiation monitor which is installed in the GammaMed unit. The lights are preprogrammed to illuminate whenever greater than approximately I 0.3' rem /hr (3 mSv/hr) is detected. This provides the user positive indication'that the source is extended or secured as well as an indication that the source may not have fully retracted. This may be confirmed by the operator viewing the SGT (which is constructed of translucent material) to determine if the source cable is visible. If the radiation monitor detects j
r 1:
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE N_Di NR-0726-D-801-S DATE: August 23, 1999 PAGE: 7 OF 16 l
l DEVICE TYPE: Brachytherapy HDR Remote Afterloader l
DESCRIPTION: ,(Cont'd) l levels. greater than 0.3 rem /hr two seconds after a retract has been initiated,. audible.(continuous beeping) and visual (flashing
' lights) alarms will indicate this condition a'nd the error message
" radiation" will~be displayed on the control console' screen.
A printout is generated during each treatment which highlights the treatment. performed. If any error messages are generated they will'be included in the printout. With this printout and the record stored in the computer,'the user will be able to determine the exact time the error occurred and the position and status of the source. This printout also can be used as a permanent record of the patients treatment.
.A review of the treatment planning software is beyond the scope of this safety analysis. Software design and testing analysis is ,
performed by the Food and Drug Administration for medical- '
devices.
The GammaMed-121 is substantially the same as-the GammaMed 12it.
The-devices incorporate the same source drive mechanism, indexer, electronic control system, safety features, and interlocks. The only differences between the devices are:
- 1. physical appearance - the GammaMed 12it has an outer housing that affords greater protection of the shield and source to meet Type A transport packaging requirements.
- 2. the mechanisms for controlling height and movement of.the head of the unit and the unit stand.
r The'GammaMed 121 was. originally registered with the State of New York by Mick-Radio Nuclear Instruments and the GammaMed 12it was originally registered with NRC by RTS Technology, Inc. However, Frank Barker ~ Associates, Inc. has taken responsibility for distribution of the devices within the U.S. RTS will continue to supply the sources to the customers for the devices.
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1 -
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-REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES-u SAFETY EVALUATION-OF DEVICE
- HQ1 NR-0726-D-801-S DATE: Austst 23, 1999 PAGE: 8 OF 16 DEVICE TYPE:- Brachytherapy.HDR Remote Afterloader DESCRIPTION: .(Cont'd)
Cylindrical transport containers provided by the manufacturer (see Attachment-4), are used for transportation and temporary l storage of new or used sealed sources. During.an installation process the old sealed source is removed from the device and placed into the transport container while the-new source is taken out of the transport container and inserted it into the device. Two different ports (oneLfor the new source and one for the used source) are joined to a cylindrical Wolfram (tungsten
- alloy) shield mass approximately 2" (50 mm) in diameter.and 2.6" (67 mm) high by stainless steel channelsL(tubing). Each sealed l - source is held in place by a lever. The interior of the container has 33 lbs. (15 kg)' of lead-for additional shielding.
'Overall dimensions of the container are approximately 6 2"
. (158,
, mm) in diameter and 13.9" (354fmm) high. Total weight is approximately.55.lbs. (25 kg) . A handle is attached for hand carrying.
- LABELING:
The Model 12i includes-the following five labels:
- 1. The manufacturers identification label which is constructed of aluminum and contains the manuf acturer's name, model number and serial number. It is mounted on the rear of the stand.
I 2 Two radiation labels, one is silk screened on each side of the stainless steel sleeve that covers the depleted uranium shield. Each .'.abel includes the word radioactive, the radiation symbol, and the isotope and capacity of the device.-
- 3. A lexan label, attached to the rear of the device, that
{ indicates the' inclusion of 26 lbs. (12 kg) of depleted I
uranium and includes the name, address, and telephone number of the distributor.
I
. i 1
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REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE l l
NO: NR-0726-D-801-S DATE: Aufpst 23, 1999 PAGE: 9 OF 16 i l
DEVICE TYPE: Brachytherapy HDR Remote Afterloader !
LABELING (Cont'd): j
- 4. A stainless steel source identification which is supplied I with the source assembly. It is attached with adhesive on top of the device.
The Model 12it includes the following five labels:
- 1. The manufacturers identification label which is constructed of aluminum and contains the manuf acturer's name, model number, serial number, isotope and capacity of the device, and Type A package identification. It is mounted on the rear of the device, j l
2 Two radiation labels, one on each side of the device, l contain the word radioactive and the radiation symbol.
- 3. A lexan label that indicates the inclusion of 26 lbs. (12 kg) of depleted uranium and includes the name, address, and telephone number of the distributor. It is located on top !
of the device.
- 4. A stainless steel source identification which is supplied with the source assembly. It is attached with adhesive on the side of the device. ]
The Transport Container bears:
- 1. A metal identification plate, on the side, that contains the standard radiation symbol, isotope, maximum activity, total weight, serial number, and manuf acturer's name.
- 2. 'A circular metal plate, on the top, with the same
! information.
i DIAGRAM:
See Attachments 1-4.
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REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE NO: NR-0726-D-801-S DATE: Ainsst 23, 1999 PAGE: 10 OF 16 DEVICE TYPE: Brachytherapy HDR Remote Afterloader CONDITIONS OF NORMAL USE:
The afterloaders are designed to be used in conditions typically associated with hospitals and medical facilities for the treatment of cancerous tumors. Treatment is typically performed with device and patient located in the same room. Therefore, these environs would fit for human occupancy.
Frank Barker Associates claims the Model GammaMed 12it is designed to be easily transported from one location to another and that conditions of transport would be typical of those of other medical products. In support of this claim, Frank Barker Associates has submitted test procedures and results which indicate the unit has been subjected to and passed Type A package testing.
The devices are not designed to be subjected to temperatures greater than 104*F (40*C).
PROTOTYPE TESTING:
RTS tested a prototype unit of the GammaMed 12it to the requirements for a DOT specification 7A, Type A package. No reduction in the structural integrity or shielding efficiency of the unit was noted by RTS following the testing. However, some deformation of the package was noted as a result of the Free Drop, Corner Drop, Compression, and Penetration tests.
Frank Barker Associates claims that Model GammaMed 12i units have been in use in the U.S. since 1989 and other similar devices have been in use in the U.S. and the UK for more than 10 years prior with no major instances of a failure of the units reported.
Frank Barker Associates claims that a prototype GammaMed 12it, containing only dummy sources, has been shipped to various hospitals and trade shows around the U.S. for demonstration purposes for over a year with no reduction in operability and no damage to the unit except scratches.
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE HQL NR-0726-D-801-S DATE: Augist 23, 1999 PAGE: 11 OF 16 DEVICE TYPE: Brachytherapy HDR Remote Afterloader PROTOTYPE TESTING (Cont'd):
Prototypes of the Models 721 and 724 source assemblies have received ANSI N542-1977 classifications of 77C53312, been subjected to a repetitive, tensile force, cyclic test using a 13 lb (58 N) load (approximately three times the maximum load the Model GammaMed 12it may exert) repeatedly applied and released 100 times, and have been shown to withstand a tensile force of up to 30 lbs (133 N). Additionally, a prototype Model 721 remained operational after being subjected to 30,000 complete operational cycles and a prototype Model 724 remained operational for up to 20,000 complete operational cycles.
EXTERNAL RADIATION LEVELS:
Frank Barker Associates reported the following dose rates for a Model GammaMed 12it when loaded with 12 curies of Iridium-192.
The dose rates were extrapolated from actual measurements of a GammaMed 12it loaded with 9.6 curies (355 GBq) of Iridium-192.
l Surface 10 cm (3.94") 20 cm (7.87") 1m (39.4")
Top 1.9(19) 1.0(10) 0.5(5) < 0.1 (<1 )
Right 1.0(10) 0.5(5) 0.4(4) < 0.1 (<1)
Front <0.1(<1) < 0.1 (<1 ) < 0.1 ( < 1 ) <0.1 (<1)
Left 1.0(10) 0.5(5) 0.4 (4) 0.1 Rear 2.5(25) 1.0(10) 0.4 (4 ) <0.1(<1)
Bottom 0. 4 (4 ) 0.3(3) 0.1(1) < 0.1 (<1) l i
Dose rates are listed in mR/hr with the pSv/hr in parentheses. Locations of measurements are with respect to the outer housing of the device.
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REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE NO: NR-0726-D-801-S DATE: Auglst 23, 1999 PAGE: 12 OF 16 .
DEVICE TYPE: Brachytherapy HDR Remote Afterloader EXTERNAL RADIATION LEVELS (Cont'd):
Frank Barker Associates reported the following dose rates for a Model GammaMed 12i when loaded with 12 curies of Iridium-192.
The dose rates were extrapolated from actual measurements of a GammaMed 12i loaded with 11.2 curies (414 GBq) of Iridium-192.
Surface 5 cm (2") 30 cm (11.8") 1m (39.4")
Top 6.1(61) 1.7(17) 0.3(3) < 0.1 ( <1 ) 4 Right 4.7(47) 1.7(17) 0.2 (2) < 0.1 (<1 )
Front 1.4(14) 0.9(9) 0.2 (2) < 0.1 (<1 ) q Left 5.4(54) 1.7(17) 0.4 (4) < 0.1 (<1)
Rear 0.4 (4) 0.2 (2) < 0.1 (<1 ) <0.1 (<1 )
Bottom 4.1(41) 1.3(13) 0.2 (2) <0.1 (<1 )
Dose rates are listed in mR/hr with the pSv/hr in parentheses. !
l OUALITY ASSURANCE AND CONTROL:
The devices are manufactured under the quality assurance program of Isotopen-Technik Dr. Sauerwein, GmbH in accordance with the requirements of the German government for devices containing radioactive material.
In addition, Frank Barker Associates subjects each device to an incoming quality assurance program consisting of the following:
- General inspection of the device for completeness and shipping damage.
Inspect the indexer for proper installation and operation.
Inspect the drive mechanisms for proper installation and operation.
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE NO: NR-0726-D-801-S DATE: Aug2st 23, 1999 PAGE: 13 OF 16 DEVICE TYPE: Brachytherapy HDR Remote Afterloader OUALITY ASSURANCE AND CONTROL (Cont' d) :
Inspect the electronics for proper installation and operation.
Inspect the brake mechanism for proper operation.
Inspect the computer and associated hardware for proper operation.
Install the GammaMed program and verify that the program I properly detects faults and that all safety features of the program are performed correctly.
Inspect the SGTs and applicators for proper length and condition.
Perform a source exchange and check unit for normal operation, i
)
LIMITATIONS AND/OR CONSIDERATION OF USE: 1 The Models GammaMed 12it and GammaMed 12i shall be distributed only to persons specifically licensed by the NRC or an Agreement State.
The devices shall not be subjected to temperatures greater than 104*F (40"C).
The devices shall be leak tested at intervals not to exceed 6 months using techniques capable of detecting the presence of 0.005 microcurie (185 Bq) of removable contamination.
Handling, storage, use, transfer, and disposal are to be determined by the licensing authority. In view that the sources used in this device exhibit high dose rates, the sources should be handled only by experienced licensed personnel following the manufacturer's instructions.
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REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE NO: NR-0726-D-801-S DATE: Aussst 23, 1999 PAGE: 14 OF 16 DEVICE TYPE: Brachytherapy HDR Remote Afterloader LIMITATIONS AND/OR CONSIDERATION OF USE (Cont'd):
The devices shall be initially installed and tested for proper operation of all systems prior to any treatment of humans. Installation shall only be performed by Frank Barker Associates or persons specifically licensed by the NRC or an Agreement State to install the devices.
The Models GammaMed 12it and GammaMed 12i afterloaders shall only be used with RTS Models 721 and 724 source assemblies or with other source assemblies as specified in a registration certificate issued by the NRC or an Agreement l State.
)
REVIEWER NOTE: The GammaMed 12it has been tested to Type A package requirements. However, the device may only be used at locations as listed on a license issued by NRC or an Agreement State. Following transport from one location to another, the device must be properly installed by persons specifically licensed by NRC or an Agreement State to install the devices at the new location.
- REVIEWER NOTE: The built-in radiation monitor is a redundant safety feature and is not deemed to meet the requirement for an independent room monitor or portable survey meter.
REVIEWER NOTE: Policy and Guidance Directive 86-4 should be followed when licensing this device.
REVIEWER NOTE: The GammaMed 12i was originally registered with the State of New York by Mick-Radio Nuclear Instruments and the GammaMed 12it was originally registered with NRC by RTS Technology, Inc. However, Frank Barker Associates, Inc.
has taken responsibility for distribution of the devices l
within the U.S. RTS will continue to supply the sources to i the customers for the devices.
- This registration sheet and the information contained within the references shall not be changed without the written consent of the NRC.
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE HQ1 NR-0726-D-801-S DATE: Aupist 23, 1999 PAGE: 15 OF 16 DEVICE TYPE: Brachytherapy HDR Remote Afterloader LIMITATIONS AND/OR CONSIDERATION OF USE (Cont'd):
- REVIEWER NOTE: There are 18 units sold and still in use.
All service for these units, including source replacement, will be performed by MDS Nordion. Their address is 413 March Road, PO Box 13140, Kanata, Ontario Canada K2K 2B7.
SAFETY ANALYSIS
SUMMARY
Frank Barker Associates, Inc. will no longer distribute or service the Gamma products. As a distributor, no changes were made to the product since the last amendment.
Based on our review of the information and test data cited below, ,
that.no major failure of either device has been reported, and that the Type A packaging of the GammaMed 12it provides additional protection to the exposure device, we conclude that the Model GammaMed 12it and GammaMed 121 are acceptable for licensing purposes.
Furthermore, we conclude that the devices would be expected to maintain their containment integrity for normal conditions of use which might occur during the uses specified in this registration sheet.
RE FERENCES : l l
The following supporting documents for the Model GammaMed 12it and GammaMed 121 afterloaders are hereby incorporated by i reference and are made a part of this registry document:
- RTS technology, Inc. application dated June 6, 1991, and subsequent letters dated August 28, 1992, January 19, 1993, I September 9, 1993, and September 10, 1993, with enclosures thereto. I
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE HQ1 NR-0726-D-801-S DATE: August 23, 1999 PAGE: 16 OF 16 DEVICE TYPE: Brachytherapy HDR Remote Afterloader REFERENCES (Cont'd):
Frank Barker Associates, Inc. letters dated June 2, 1995, May 8, 1995, May 10, 1995, July 28, 1994, July 8, 1994, Movember 11, 1993, and June 4, 1996, with enclosures thereto.
Operator's Manual for the GammaMed 12it received from Frank Earker Associates on July 27, 1994.
Frank Barker Associates, Inc. letter dated June 29, 1999 and August 12, 1999.
Frank Barker Associates, Inc. facsimile dated August 4, 1999 and August 13, 1999.
ISSUING AGENCY:
U.S. NUCLEAR REGULATORY COMMISSION Date Atmner 71_ 1944 Reviewer -
Setifig J. Lee Date August 23, 1999 Concurrence ,PL Pfd4D
(/ Johd' P. Jankovich j l
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- .I REQUEST FOR A SEALED SOURCE OR DEVICE EVALUATION INSTRUCTIONS:
Send this request AND a copy of all related letters /apphcations and drawings to: The Seak rce Safety Section, ATTN: Chief, OWFN Mail Stop 6 H3 Change the License Tracking System milestone to 19 and assign to revie er codr, v NOTE: Retain a copy of this request with the application and background flies.
WEQUESTER ]{
nJdpA REGION / LOCATION:
7: R ii Riii R IV V HQ TELEPHONE 40MBER ~ DATE LFDCB TYPE OF ACTION REQUESTED (Check as appropriate)
APPUCANTS N -
SOURCE REVIEW A A 0/Jr [/ /7~
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AMENDMENT OF REGISTRATION SHEET MAL CONTROL huMBER(S) g DEVICE REVIEW NWBER(S)
W TO ATE UCENSE NUMBER (S)
LETTER 7 /A?2 9 (N99 m-a mA-nl CUSTOM REVIEW A//h- 7M- A-/N-N c ""'""
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Joum, NJ o90ga FOR SSSS USE ONLY REVEWER . NUMBERS NUMBER ASSONED nn f/ l/9 . c-in m m 5 ,/ M? 7' 99- 48 DATE4fECEIVED y '/ DATE ASSONED DATE TO FEES
'7-4 %- 9 9 7 <D 9- 9 9 9-49-99 TYPE OF ACTION (Indicate the number of each type)
MCOMMERCIAL DISTRIBUTION (FORMAL) l USE BY A SINGLE APPLICANT (CUSTOM)
SOURCE (9C) DEVICE (9A) SOURCE (9D) DEVICE (9B)
NEW NEW NEW NEW
] AMENDMENT
[ AMENDMENT AMENDMENT AMENDMENT
[ NO SAFETY EVALUATION REQUIRED NO FEES REQUIRED j LICENSING ACTION REQUIRED IF KNOWN --
j OTHER (Spec #y) NO TOTAL NUMBER OF NOTES
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ADD TO BILLING REMOVE FROM BILLING FOR FEE USE ONLY TYPE OF FEE FEE CATEGORY CMOUNT RECEIVED M
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