ML20206U050
| ML20206U050 | |
| Person / Time | |
|---|---|
| Issue date: | 02/23/1999 |
| From: | Bhachu U, Jankovich J NRC |
| To: | |
| Shared Package | |
| ML20206U022 | List: |
| References | |
| SSD, NUDOCS 9905250021 | |
| Download: ML20206U050 (11) | |
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REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (AMENDED IN ITS ENTIRETY)
NO.: NR-687-D-101-S DATE: PAGE 1 OF 8 DEVICE TYPE: Teletherapy Unit l
l MODEL: T1000, T1000E and Elite 100 MANUFACTURER / DISTRIBUTOR:
Theratronics International, Ltd l (formerly Atomic Energy of Canada, Ltd.)
l 413 March Road l P.O. Box 13140 Kanata, Ontario, Canada K2K 2B7 l
SEALED SOURCE MODEL DESIGNATION:
Theratronics Model C-146 or Model C-151 JSOTOPE: MAXIMUM ACTIVITY:
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Cobalt-60 15,000 Curies (405 GBq)
Depleted Uranium 231 pounds (105 kg)
LEAK TEST FREOUENCY: 6 Months PRINCIPAL USE: (C) Medical Teletherapy CUSTOM DEVICE: YES X NO t /{
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REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (AMENDED IN ITS ENTIRETY)
NO.- NR-687-D-101-S DATE: IU 2 3 333 PAGE 2 OF 8 DEVICE TYPE: Teletherapy Unit DESCRIPTION: 1 1
The Theratron T1000, T1000E, and Elite 100 are rotational teletherapy units with the head and beam stopper on a "C" arm I which rotates about the patient. Functionally, they are identical to the Theratron 780C except that they have a stretched arm and two hand controls supported by overhead booms.
Collimator controls are located on the hand control instead of the controls mounted on the head. They can be operated in four modes; fixed, rotational,' arc, and skip. A built-in beam-defining lamp and optical distance indicator aid the operator in establishing the correct source-to-skin distance (SSD) and patient position. The majority of the unit's functions are motor operated and can be controlled from either a hand control located near the unit, or a control console located outside the treatment room.
The units are designed to treat at a source-to-axis distance (SAD) of 39.4 inches (100 cm) and the beam center line position is accurate to within 1 0.039 inches (1 mm). A steel encased, lead ~ filled optical beam stopper attenuates 99.7% of the primary beam and reduces by the same factor radiation scattered by the patient through an angle of up to 35 from the central ray. The approximate weight of the unit is 13,000 pounds (5900 kilograms) and overall height is 111 inches (281.9 cm).
The units contain up to 231 pounds of depleted uranium shielding or may contain an optional tungsten shield within the source head. The units may have one of three different bases (tables).
The base with table Model 73 or Model 73M is 54 x 64 inches (137 '
x 162.6 cm). The base for Model 23T is 50 x 99 inches (127 x 251.5 cm).
The cobalt-60 sealed source is placed and secured with a i
stainless steel retaining ring in a lead filled, brass encased source drawer. The source drawer is attached to a pneumatic cylinder which allows horizontal movement of the sealed source.
The lead ^and depleted uranium (alloyed or unalloyed) or tungsten collimation assembly defines a field size which can be varied from 1.97 to 16.7 inches (5 to 42.5 cm) for a 21.7 inch (55 cm) l source to diaphragm distance. The source to diaphragm distance can be reduced to 17.7 inches (45 cm) by removing the trimmers,
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REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES l " SAFETY EVALUATION OF DEVICE (AMENDED IN ITS ENTIRETI)
NO.: NR-687-D-101-S DATE: '2 " PAGE 3 OF 8 DEVICE TYPE: Teletherapy Unit l l
DESCRIPTION (cont'd)1 with a field size varying from 2.5 to 17.2 inches (6.3 to 43.7 cm).
The head will swivel through 180 and does not angle forward or backward. Beam orientation is limited by two mercury switches.
Lights on the source head indicate the "On" and "Off" and source "In Transit" positions. A fluorescent red-tipped rod extends approximately 5 inches through the front end of the unit top head cover and mechanically indicates the soerce position.
In the event of an interruption to the electrical power, the source will automatically withdraw to the "OFF" position. In case of an emergency the source can be placed in the "OFF" position by an operator pushing the Emergency Off Switch. If this fails, the source drawer can be mechanically pushed to the "Off" position by use of an emergency T-bar.
Alarms on the unit (bell or buzzer) and at the control console (high frequency tone) sound off if a failure occurs in the source )
drawer mechanism.
The devices use a dual timer control system on the console. Both timers independently measure treatment time by monitoring source drawer position and movement time. Any differences in the preset time variance will cause the drawer to be returned to the shielded position. l l
The source exposure mechanism is inspected and serviced during source exchanges or at intervals not exceeding 5 years. This time period corresponds to approximately 40,000 on/off cycles.
The Model T1000E differs from the T1000 in that this model meets, in addition to the specifications for the other model, the provision of the International Electrotechnical Commission Standard IEC 601-2-11, 1987. The modifications affect the radiation protection and electrical control systems. Regarding radiation protection, an additional tungsten shield was added to the collimator in the therapy head design to reduce incidental radiation leakage when the source is in transit stage between
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, REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (AMENDED IN ITS ENTIRETY) re ; e 339 NO.- NR-687-D-101-S DATE: PAGE 4 OF 8 DEVICE TYPE: Teletherapy Unit DESCRIPTION (cont'd):
" Beam On" and " Beam Off" positions. In order to accommodate the additional shielding in the therapy head design, the geometry of the primary definer was also changed. Regarding electrical controls, modifications were made in gantry fault monitoring, interlocks, and external controls.
The Model Elite 100 includes the design features of the Model T1000E and meets the provisions of the International Electrotechnical Commission Standard IEC 601-2-11, Second Edition 1997. Meeting the provisions of IEC 601-2-11, Second Edition 1997, resulted in interchanging the x and y field size parameters of the position indicators with respect to the Model 1000 Series.
The control system of the Elite 100 teletherapy unit is equipped with electronic operator controls with respect to the push-bottom ;
style controls used on the Model 1000 series. Functionally, the l
two control systems are identical. l LABELING:
Each uranium component-is permanently labeled with " CAUTION, RADIOACTIVE SHIELDING URANIUM". In addition, radiation caution
. plates with the radiation symbol and the words " CAUTION RADIOACTIVE", or " CAUTION RADIOACTIVE MATERIAL" are permanently attached to the source head and cabinet. Additional labels contain the manufacturer's name and the device model number.
DIAGRAM:
See attachments 1, 2, and 3.
CONDITIONS OF NORMAL USE:
The Model T1000 and T1000E Teletherapy Units are designed for use in hospital or clinic environments for the treatment of patients with cancer. Conditions of use include a clean but not sterile area, conditioned air and adequate lighting and ventilation.
Shielding in the form of poured concrete or lead is typically used to surround the treatment area. Considering the shielded
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REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (AMENDED IN ITS ENTIRETY)
NO. NR-687-D-101-S DATE: TES 2 3 m) PAGE 5 OF 8 DEVICE TYPE: Teletherapy Unit CONDITIONS OF NORMAL USE (cont'd)-
room environment in which the device is used, the probability of severe conditions including accidents and fires is small.
The source exposure mechanisms are inspected at intervals not to exceed five years, or during source replacements. l The device is expected to be subjected to approximately 40,000 l On/off cycles between source changes.
PROTOTYPE TESTING:
The main difference between the T1000, T1000E, and Elite 100 models with respect to the Model 780C is the extended arm.
Stress calculations by direct measurements of arm deflection were performed by the manufacturer. The results showed less than 0.039 inches (1 mm) of deflection. ,
For those units that are to be placed in high earthquake risk areas additional precautions have been taken. The device is l bolted in a 10 inch (25.4 cm) deep pit by concrete anchors. The pit is then filled with high density concrete.
The T-1000, T1000E and Elite 100 were also found to comply with the requirements of Canadian Standards Association Standard C22.2 No. 114-1980, and the National Council on Radiation Protection (NCRP) 33.
EXTERNAL RADIATION LEVELS:
The manufacturer has determined that the head can be loaded with up to 15,000 curies of cobalt-60. The average dose rate readings taken from points around the device do not exceed 2 mR/hr (0.02 mSv/hr) and no point exceeds 10 mR,Jhr (0.1 mSv/hr). Small areas of reduced protection, however, are acceptable in evaluating the maximum exposure rate providing the average over 15.5 square inches (100 square cm) at 39.4 inches (1 m) from the source does not exceed 10 mR/hr. The device meets the requirements stated l above according to NCRP 33 4.2.2. The Model T1000E meets the
r j REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVIC l
SAFETY EVALUATION OF DEVICE (AMENDED IN ITS ENTIRETY)
NO.: NR-687-D-101-S DATE: i:- iU PAGE 6 OF 8 DEVICE TYPE: Teletherapy Unit EXTERNAL RADIATION LEVELS (cont'd)-
i International 1987. Electrotechnical Commission Standard IEC The Model Elite 100 meets the provisions of the 601-2-11 ,
International Second EditionElectrotechnical 1997. Commission Standard IEC 601-2-11 ,
OUALITY ASSURANCE AND CONTROL:
l Theratronics International Limited maintains a quality assurance and control licensing prograr.bywhich purposes NRC.has been deemed acceptable for NRC. A copy of the program is on file with LIMITATIONS AND/OR OTHER CONSIDERATIONS OF USE:
Theratronics Model T1000 and T1000E Teletherapy Units shall be distributed 35.600 10 only to persons specifically licensed under i CFR Part 35 or under equivalent by the Nuclear Regulatory Commission regulations of an Agreement State.
The device shall be installed and initially tested for proper operation warning of the source exposure mechanism, components, safety labels, external radiation levels l (source exposed, source shielded) and leak tested by the manufacturer or other persons specifically licensed by the NRC or an Agreement Handling, storage, use, transfer, and disposal: To be determined by the licensing authority. Source transfer involves exchanging source drawers with a shipping container containing two drawer compartments. Replenishment of the two
" rider rings" supporting the source drawers is l .recommended replacement. by the manufacturer every 5 years or at source The device shall be leak tested at intervals not to exceed six (6) l months using techniques capable of detecting 0.005 microcuries (185 kBq) of removable contamination.
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REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (AMENDED IN ITS ENTIRET"'-
NO. NR-687-D-101-S DATE: fif 2 J id PAGE 7 OF 8 DEVICE TYPE: Teletherapy Unit LIMITATIONS AND/OR OTHER CONSIDETATIONS OF USE (cont'd)-
+ REVIEWER NOTE: The applicant must demonstrate compliance ,
with Subpart-I, 10 CFR Part 35 (in particular Section 35.615) I before a license can be issued.
+ The user can perform maintenance on the device only as provided in the Model T-1000, T1000E, and Elite 100 operation manual.
. This registration rheet and the information contained with the references shall not be changed without the written consent of the NRC. I SAFETY ANALYSIS
SUMMARY
Based on our review of the Theratronics' Model T1000, T1000E and Elite 100 Teletherapy devices and the information and test data cited below, we continue to conclude that this device is acceptable for specific licensing purposes.
Furthermore, we continue to conclude that these devices would be expected to maintain containment integrity for normal conditions of use and accidental conditions which might occur during uses specified in this certificate.
REFERENCES:
The following supporting documents for the Model T1000, T1000E and Elite 100 Teletherapy devices are hereby incorporated by reference and are made a part of this registry document.
+ Theratronics' application dated June 21, 1989, and subsequent letters dated February 19, 1990, May 14, 1990, August o.
1991, August 20, 1991, and November 17, 1992, and telo: axes dated February 13, 1990, and March 28, 1990, with enclosures thereto.
. Theratronics International Limited's letters dated November 1, 1996, November 24, 1997, December 12, 1997, with enclosures thereto.
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DE" ICE (AMENDED IN ITS ENTIRETY)
TEE . ) 1H NO.- NR-687-D-101-S DATE: PAGE 8 OF 8 DEVICE TYPE: Teletherapy Unit REFERENCES (cont'd)-
Submission of Theratronics International Limited QA Manual with letter dated September 29, 1997, with enclosures .
thereto. l l
- Theratronics International Limited's letters dated July 17, 1998, November 9, 1998, December 11, 1998, and February 15, 1999, with enclosures thereto.
ISSUING AGENCY:
I U.S. NUCLEAR REGULATORY COMMISSION f EB 2 3 '3H p l gk f ,
DATE: REVIEWER:
dohn P. #ankovich, Ph.D.
DATE: CONCURRENCE:
- U chu, P.Eng.
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NO.- NR-687-D-101-S DATE:
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