ML20151L565
| ML20151L565 | |
| Person / Time | |
|---|---|
| Issue date: | 07/21/1997 |
| From: | Steven Baggett, John Lubinski NRC |
| To: | |
| Shared Package | |
| ML20151L556 | List: |
| References | |
| SSD, NUDOCS 9708070043 | |
| Download: ML20151L565 (20) | |
Text
. _.. _. _. _. _,. ~.. -. _... -
-.__._~______.___.._._m.=..
l l
I I
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES l
SAFETY EVALUATION OF DEVICE
}
(AMENDED IN ITS ENTIRETY)
HQ1 NR-726-D-101-S DATE: July 21, 1997 PAGE: 1 OF 15 i
DEVICE TYPE: ~ Brachytherapy HDR Remote Afterloader l
i MODEL:
GammtMed 12it, GammaMed 121 l
l L
L DISTRIBUTOR:
Frank Barker Associates, Inc.
L 33 Jacksonville Road, Bldg. #1 Towaco, NJ 07082 MANUFACTURER:
Isotopen-Technik Dr. Sauerwein, GmbH l
Bergische-Str. 16 D-5657 Haan, Germany i
l-SEALED SOURCE MODEL DESIGNATION:
RTS Models 721, 724 p
i ISOTOPE:
MAXIMUM ACTIVITY:
l Iridium-192 12 curies (444 GBq)
Depleted' Uranium
-26 lbs. (12 kg) l I
i LEAK TEST FREOUENCY:
6 months
)
i l
PRINCIPAL USE: (V) General Medical Use i
l CUSTOM DEVICE:
YES NO X
l
{
9700070043 970725 PDR RC SSD PDR s?
i i -
=
~.
_ - = -. _. -
~. _ _. - - -
l.
l REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (AMENDED IN ITS ENTIRETY) i NO: NR-726-D-101-S~
DATE: July 21, 1997 PAGE: 2 OF 15 l
DEVICE TYPE:
Brachytherapy HDR Remote Afterloader l
DESCRIPTION:
l The Model GammaMed 12it High Dose Rate (HDR) remote afterloading i
brachytherapy irradiator is a mobile unit designed for the controlled irradiation of cancerous tissue with a predetermined l
dose delivered directly to the affected tissue by placing: the l
radioactive source insioe 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 i
customized to deliver maximum damage to the cancerous tissue with minimal damage to healthy tissue.
The source used in the device l
contains a nominal activity of 10 curies (370 GBq), maximum l
i activity of 12 curies (444 GBq), of iridium-192.
l The unit contains 24 ports through which the source may be I
sequentially passed in order to provide for irradiation at i
various locations within the patient, each with a unique dose j
i 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 i
source from passing through any port which does not have a SGT j
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 l
switches and optical sensors, an emergency hand crank, a built-in j
j Geiger-Mnller 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
(112 kg).
i Security from unauthorized use of the device / source is provided by means of a mechanical / electrical key lock located on the control console.
T
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (AMENDED IN ITS ENTIRETY)
NO: NR-726-D-101-S DATE: July 21, 1997 PAGE: 3 OF 15 DEVICE TYPE:
Brachytherapy HDR Remote Afterloader l
DESCRIPTION: (Cont'd) l 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) l past the maximum treatment position.
If the drive motor does not l
encounter resistance due to the source reaching the end of the applicator, an interrupt is initiated, treatment is halted, and l
the error message " Probe Tube too long" is displayed at the l
control console.
Likewise, if any of the other tests fail, a l
treatment interrupt is initiated a similar error message is generated at the control console.
The operator must acknowledge l
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 u t will retest the channel that failed to ensure the fault has ceen corrected.
l The dummy source can also be used to verify actual source l
position as compared to progranmed 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.
l After the dummy source has been cycled through the selected l
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 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 discal end of the applicator, the length 4
1 i
l l
l REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (AMENDED IN ITS ENTIRETY)
NO: NR-726-D-101-S DATE: July 21, 1997 PAGE: 4 OF 15 DEVICE TYPE:
Brachytherapy HDR Remote Afterloader i
DESCRIPTION: (Cont'd) 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 l
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 l
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 i
either the live or dummy sources.
If the emergency crank fails i
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.
1 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 i
l portability which can be locked for treatment.
The trolley also houses the battery backup system.
In case of a power failure, l
the battery backup will supply enough power to retract the source l
and retain the treatment plan in memory.
Treatment cannot be continued until AC power has been restored and battery voltage i
l has been restored to a level sufficient to perform a source retract.
If at any time during treatment battery voltage drops l
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
i i
l REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (AMENDED IN ITS ENTIRETY) l NO: NR-726-D-101-S DATE: July 21, 1997 PAGE: 5 OF 15 DEVICE TYPE:
Brachytherapy HDR Remote Afterloader i
DESCRIPTION: (Cont'd) 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 o
1 interrupts and emergency aborts which are discussed below.
l 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 l
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 i
. stored position, and notify-the operator of the reason for the i
interrupt via a beep and message at the control console.
Once i
the error has been corrected and the command to continue I
treatment is issued, the unit will attempt to continue the q
treatment using the dummy source.
If no errors are detected, treatment will continue.
l An emergency abort occurs when the unit detects a situation where l
treatment cannot continue and harm to the patient or unit is possible.
Following an emergency abort, an emergency error message screen will be displayed at the control console which i
j indicates the reason for the emergency abort, the time the error occurred, the channel selected, and the position of the source at I
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 I
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 i
l l
l l
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES l
SAFETY EVALUATION OF DEVICE l
(AMENDED IN ITS ENTIRETY)
NOt NR-726-D-101-S DATE:' July 21, 1997 PAGE: 6 OF 15 l
- DEVICE TYPE:
Brachytherapy HDR Remote Afterloader DESCRIPTION: (Cont'd) i j
to the calculated position or if-the length of the source was i
l measured to not be within specifications.
The treatment plan is stored in the control console as well as l
the-computer.'
During treatment, each plan is compared for l
consistency.
If any discrepancies in the treatment plans are l
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 L
0.2 seconds, the treatment is halted and an error message is generated.
t The control console contains one RADIATION WARNING light and the l.
GammaMed unit contains two RADIATION WARNING lights (one on each j
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 0.3 rem /hr (3 mSv/hr) is detected.
This provides the user i
positive indication that the source is extended or secured as l
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 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 and the error message i
" 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.
l A' review of the treatment planning software.is beyond the scope of thic safety analysis.
Software design and testing analysis is performed by the Food and Drug Administration for medical
{
devices.
i 2
--. -.. -. ~.
.- ~
f l
n l'
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (AMENDED IN ITS ENTIRETY) i l
'HQ1 NR-726-D-101-S DATE: July 21,.1997 PAGE: 7 OF 15
(
. DEVICE TYPE:
Brachytherapy HDR Remote Afterloader i
l DESCRIPTION: (Cont'd) i The GammaMed 12i is substantially the same as the GammaMed 12it l
The devices incorporate the same source. drive mechanism, indexer, electronic control system, safety features, and interlocks.
The only differences between the devices are:
i l
1.
physical appearance - the GammaMed 12it has an l
outer housing that affords greater protection of the shield and source.to meet Type A transport l
l packaging requirements.
2.
the mechanisms for controlling height and movement of the head of the unit and the unit stand.
L The-GammaMed 121 was originally registered with the State of New l
l York by Mick-Radio Nuclear Instruments and the GammaMed 12it was l
originallyLregistered with NRC by RTS Technology, Inc.
- However, Frank Barker Associates, Inc. has taken responsibility for i
distribution of the devices within the U.S.
RTS will continue to supply the sources to the customers for the devices.
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 i
placed into the transport container while the new source is L
taken out of the transport container and inserted it into the j
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" 1
(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.
L 1
a' l
l
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES i
SAFETY EVALUATION OF DEVICE (AMENDED IN ITS ENTIRETY)
HQ1 NR-726-D-101-S DATE: July 21,-1997 PAGE: 8 OF 15 DEVICE TYPE:
Brachytherapy HDR Remote Afterloader 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 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 cf 26 lbs. (12 kg) of depleted uranium and includes the name, address, and telephone number of the distributor.
4.
A stainless steel source identification which is supplied with the source assembly.
It is attached with adhesive on top of the device.
l The Model 12it includes the following five labels:
I 1.
The manufacturers identification label which is constructed of aluminum and contains the manuf acturer's n.me, 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, i
contain the word radioactive and the radiation symbol.
l l
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
m. _ __ __ _
i REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE
+
(AMENDED IN ITS ENTIRETY)
NO: NR-726-D-101-S DATE: July 21, 1997 PAGE: 9 OF 15 i
l j
DEVICE TYPE:
Brachytherapy HDR Remote Afterloader I
l l
LABELING: (Cont'd)
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.
1 2.
A circular metal plate, on the top, with the same information.
DIAGRAM:
See Attachments 1-4.
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).
l PROTOTYPE TESTING:
I l
RTS tested a prototype unit of the GammaMed 12it to the l
requirements for a DOT specification 7A, Type A package.
No l
reduction in the structural integrity or shielding efficiency of l
the unit was noted by RTS following the testing.
However, some I
j
.-m.
__m
__... _ ~ _ _ -. _ _ _ _ _. _. _. _. -.. _ _. _...... ~... ~._._...._.
4 1
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE i
(AMENDED IN ITS ENTIRETY) 1 HQ1 NR-726-D-101-S DATE: July 21, 1997 PAGE: 10 OF 15 l
' DEVICE TYPE:
Brachytherapy HDR Remote Afterloader l
' l a
PROTOTYPE TESTING: (Cont'd) i
. deformation of the package was noted as a result of the Free i
Drop, Corner' Drop, Compression, and Penetration tests, i
Frank Barker Associates claims that Model GammaMed 12i units have l
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-i purposes for over a year with no reduction in operability and no j
damage to the unit except scratches.
Prototypes of the Models 721.and 724 source assemblies have i
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 l
operational after being subjected to 30,000 complete operational cycles and a prototype Model 724 remained operational for up to 1
20,000 complete operational cycles.
l t
I I
p l
i.
i i
l' t
(
l l
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES l
SAFETY EVALUATION OF DEVICE l
(AMENDED IN ITS ENTIRETY) l NO: NR-726-D-101-S DATE: July 21, 1997 PAGE: 11 OF 15 DEVICE TYPE:
Brachytherapy HDR Remote Afterloader 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 (3 9. 4 ")
l 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) 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 i
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(c1) l 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.
Frank Barker Associates reported the following dose rates for a i
Model GammaMed 12i 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) 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)
Left 5.4 (54) 1.7(17) 0.4 (4)
< 0.1 ( < 1) j 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.
=
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (AMENDED IN ITS ENTIRETY)
HQ1 NR-726-D-101-S DATE: July 21, 1997 PAGE: 12 OF 15 DEVICE TYPE:
Brachytherapy HDR Remote Afterloader 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.
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 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.
l LIMITATIONS AND/OR CONSIDERATION OF USE:
l-The Models GammaMed 12it and GammaMed 12i shall be distributed only to persons specifically licensed by the NRC or an Agreement State.
l l
l l
I l
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES I
SAFETY EVALUATION OF DEVICE (AMENDED IN ITS ENTIRETY) i NQ1 NR-726-D-101-S DATE: July 21, 1997 PAGE: 13 OF 15 l
l DEVICE TYPE:
Brachytherapy HDR Remote Afterloader LIMITATIONS AND/OR CONSIDERATION OF USE: (Cont'd)
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 chould be handled only by experienced licensed personnel following the manufacturer's instructions.
l 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.
d 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.
l REVIEWER NOTE: The GammaMed 12it has been tested to Type A package requirements.
However, the device may only be used j
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.
l 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.
l REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (AMENDED IN ITS ENTIRETY)
HQ1 NR-726-D-101-S DATE: July 21, 1997 PAGE: 14 OF 15 DEVICE TYPE:
Brachytherapy HDR Remote Afterloader LIMITATIONS AND/OR OTHER CONSIDERATIONS OF USE (Cont.)-
i 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 i
within the U.S.
RTS will continue to supply the sources to the customers for the devices.
l This registration sheet and the information contained within the references shall not be changed without the written consent of the NRC.
SAFETY ANALYSIS
SUMMARY
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 continue to conclude that the Model GammaMed 12it and GammaMed 121 are acceptable for licensing purposes.
Furthermore, we continue to 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
.._m
. - _.. _ ~ _ _
I l
I REGISTRY OF RADIOACTIVE SEALED SOURCES-AND DEVICES SAFETY EVALUATION OF DEVICE (AMENDED IN ITS ENTIRETY)
HQ1 NR-726-D-101-S DATE: July 21, 1997 PAGE: 15 OF 15 DEVICE TYPS:
Brachytherapy HDR Remote Afterloader
REFERENCES:
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, September 9, 1993, and September 10,
)
thereto.
~
1993, with enclosures q
1 Frank Barker Lesociates, 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.
l Operator's Manual for the GammaMed 12it received from Frank i
Barker Associates.on July 27, 1994..
2 ISSUING AGENCY-i
[
}
U.S. NUCLEAR REGULATORY COMMISSION
/',
I is Date July 21, 1997 Reviewer
/
l Jo n W.
Lubinski Date July 21, 1997 Concurrence i
7 Steven L.
Baggett 1
I I ".
I' l
I i
o i
+
x-r i
^
a J
l 1
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (AMENDED IN ITS ENTIRETY) i NO.: NR-726-D-101-S DATE: July 21, 1997 ATTACHMENT 1 i
i l
l
?
' - v, r *
,p;c;;. -
...,,.. i,..tr,
.. rl.a,y,.,.;.
y;'e., h -
.% g'7[?-,
k",.< is..
. s.
g,7, $s".8 : I' '
8 's-.hf/4.,.
f
.'".:. dsk,,. ';D ':'?f'fut'W}:: %;.?..$..
- 'V$,.'
.,. - E
- u
<wa:
j? *:d:
't.;.
- xt:
s' a,...: -
- w :n.
- ,r drl v
~.. \\
I;.' ; :.k.^;g':. c::.
., : m..;o
/
- l nmrsamMNUll%w
."r
>:=
l
.y'i..,3'.
. _. - z _ _ _- - -.. - -
==
.j v::-
? !
7F ' i '
ll I.-
9 j
if',:.'.[, ' *,' '
l c
'.f'Y'-, h$$ -
..l$ ;
$'j'4, I
t-r -
..y.y;:.gs; s
...cOwn:. ; a:p f
'7.8'l~
.;;y -
,, ;/",%yj.:s
[1
'4
- $j
- 4..?
- M.
9.a.5p.;;
'b.'y..
j;;
e:.
"%}
i.:
.. a,
q:jf
..pt'*
?~.
t r.r i
?.,
- 6 A ",f,' "
I'
,g
-,?
r '{9
' ^ '
- .=
.r..
- N.'[ I[
!!i c..
, v. -
- .s I
! "i.;[#')
8
>: S:-
.i
' l:a' s
j,pf W'i j
- h
(
l ll
..:en
. d5,ife s.-c oc.j u.4 i
t i
i f
GammaMed 12it f
l l
I
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (AMENDED IN ITS ENTIRETY)
NO.: NR-726-D-101-S DATE: July 21, 1997 b_TTACHMENT 2 O
e
,r l.
g,w 4,,/
f
~
"A F
y$
g 27 x f:
^
SOURCE HEAD
[
~<
l e-j o
q I
Height Y AJ,;stabie from 110 cm - 150 cm o
RJ'.%0n 23(P Source Head i
l S%elding (kpfeted ()ruom
-l a
f 70; 10 3
/ ~
4 4
\\, I f \\ i. e.'s i.
1 liifiACIA' ION DEvtCE '/aTH UP T
g Type A apDroved cQntainer mth 2 3 Chave$
goc -
p
- -- a no ~ ~ ~
3 actus:acie trom 70 cm to 126 cm
, - " ~
$N.scr g Ce?OM'.* Ur3%"
e l
q Y
h3 M
I O
O 10f '
e6 h,\\in.rg /g F0 o,wns.0,w m-
l REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (AMENDED IN ITS ENTIRETY)
NO.- NR-726-D-101-S DATE: July 21, 1997 ATTACHMENT 3 internal lesuitli I300
_ _. _.I. nn e n s tin g e_ l.
(
i i
sinttal agplicator l
l l
l
--L-
- ~
- + = -[hh hll-
-j J~
- =E-il T T a C:r:-CZh
_4.l3_h.rnpur cl-Hou a. 6 o i or 12 fl. - iung a[p!icator lorr)
~ nical Applicator l
l l
l
I REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (AMENDED IN ITS. ENTIRETY)
NO.: NR-726-D-101-S DATE: July 21, 1997 ATTACHMENT 4 B-B
,. 25.19.26 l
I~
3 26.47 43 g
L
,\\,_\\
wl
\\\\s i
,_. o 16 ts_
4
. 77
\\
45 Wllr
\\
... qC
\\
10 Oig l w.1-- -
9 I
3
~
?,.
i 7
- g'
{ p-)
(
i 7
's i
d{%h-
. _1 x
cL4-b$
/
~
aI-i 1'I g %4j:P 0
p2 e
s Y
+ $)
\\
.,xo),~/~,/
% 2,
'b
-. '/
.e-y
{* <hl
. t/,/ /
6
\\\\
-1
/
j/
~ /._'
10
/
A-A j
Qf A,v-R $./,b, Q3<,N'
/
~
5,_
/
N N,-
-/
i s
/
l
/ /
^~ 5 h
b',
Q x.
n-e 1
' mSh~:.-- - - 4;,k (M~ _Q
= =
f--
J
. /,
s, -.,
ce
,g,-g,,g;,-- m q e v -.
mc
--4 2;).L_
',L':::T.?:::... B.
(
, c m :,, ve a.,
3 r, -
[ 17 f Op 9';C i' !
4' T
i r
9 i
1 l
I
ISOTOPEN-TECHNIK DR.SAUERWEIN GMBH GAMMAMED transoort container 3 Typ-A, max. Beladbarkeit: 1000 GBq (27 Ci) Ir-192, Zeichnungs-Nr.: TR 131.08.000 ACHTUNQil l
Nach dem Offnen und vor dem SchlieBen des Transportbuhnitor l
Sicherung des Strahlerkabole (OuyLest) kontrollieren. Der l
RosLstirt (Pos. 12) darf dabei nicht in einer der beiden Sicherungsbohrungen stecken.
l Entladen GannaMed (Beladen des Transportbehultersl i
- 1. GammaMed mit Adapter-Ausfahrschlauch ohne Sonde an freien Kanal anschlieBen. Den Raststift (Pos. 12) in die Sicherungsbohrung des angeschlossenen Strahlerkanals stecken, gleichzeitig den Hebel (Pos. 8) zur Seite drucken.
- 2. Strahler mit Programm "Strahlerwechsel" ausfahren. Falls nicht vorhanden, mit Hilfe der Handkurbel Strahler bis zum Anschlag ausfahren. Messen, ob der Strahler in TransportbehMlter angekommen ist.
3.
Hebel drucken, Raststift herausziehen und Hebel loslassen.
Raststift in den Beh81ter legen.
l
- 4. Ausfahrschlauch von Kanal lesen und Kabel weiter ausfahren bis Kanal vom Antrieb frei ist.
- 5. Ausfahrschlauch vom GammaMed lesen.
6.
Strahlerkabel zusammenrollen und unter den Schutzrand legen.
- 7. Behulter schlieBen und kennzeichnen.
GAMMAMED transport container 3 Type A, max. loading capacity: 1000 GBq (27 Ci) Ir-192 Drawing No.: TR 131.08-000 ATTENTIQH1 After and ll2f-QIe closing the transport container check safety of source cable (tension test).The drop-in pin must not be in one of the security bores.
Unloading GammaMed (loading of transport container) 1.
Connect GammaMed with adapter source guide tube without probe to free channel. Insert drop-in pin (pos. 12) in to security bore of connected source channel, simultaneously press lever (pos. 8) aside.
2.
Extend source with program " source change". If not available use hand crank and extend source to limit stop. Recheck i
source arrival in transport container.
3.
Press lever, pull out drop-in pin and release lever.
Place drop-in pin into container.
4.
Detach source guide tube from cable and proceed extensior. of cable until cable is released from drive.
l 5.
Release scurce guide tube from GammaMed.
l 6.
Coil source cable and place under protection rim 7.
Shut container and ma,rk, i
-