ML20206U034
| ML20206U034 | |
| Person / Time | |
|---|---|
| Issue date: | 05/21/1999 |
| From: | Bhachu U, Jankovich J NRC |
| To: | |
| Shared Package | |
| ML20206U022 | List: |
| References | |
| SSD, NUDOCS 9905250017 | |
| Download: ML20206U034 (11) | |
Text
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (CORRECTED PAGES 1, 4 & 8) l HQ1 NR-687-D-105-S DATE: Fby 21, 1999 PAGE: 1 QE_2 DEVICE TYPE: Teletherapy Unit MODEL: Theratron 780 Series (780, 780C, T780E, Phoenix, Elite 80) l MANUFACTURER / DISTRIBUTOR:
Theratronics International, Ltd.
(formerly Atomic Energy of Canada Ltd.)
l 413 March Road P.O. Box 13140 Kanata, Ontario, Canada K2K 2B7 l
l SEALED SOURCE MODEL DESIGNATION: AECL C-146 or C-151 Theratronics C-146 or C-151 ISOTOPE: MAXIMUM ACTIVITY:
Cobalt-60 15,000 Ci (555 TBq) w/ optional source i i
drawer i 13,400 Ci (495.8 TBq) w/ lead source l drawer.
Depleted Uranium Shielding 302 lbs (137 kg)
LEAK TEST FREOUENCY: 6 months PRINCIPAL USE: (C) Medical Teletherapy CUSTOM DEVICE: YES X NO 9905250017 990521 PDR RC e SSD PDR T B b d 5 O X ,/
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES I SAFETY EVALUATION OF DEVICE l (CORRECTED PAGES 1, 4 & 6)
NO: NR-687-D-105-S DATE: Fby 21, 1999 PAGE: 2 OF 9 DEVICE TYPE: Teletherapy Unit DESCRIPTION:
The Theratron 780 Series is a rotational teletherapy unit with the head and beam stopper on a "C" arm which rotates about the patient. Functionally, it is identical to the Theratron 60 and Theratron 80 models. It 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 unic'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 unit is designed to treat a source-to-axis distance (SAD) of 80 cm (31.5 in) and the beam center line position is accurate to within 1 mm (0.04 in). A steel encased, lead filled optional beam stopper attenuates 99.7 percent 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 unit stands 88.5 inches (2.25 m) high with a maximum source-to-floor distance of 77.5 inches (1.97 m). The distance between the source and the back of the unit is 94 inches (2.39 m).
The unit normally uses a Theratronics Model C-146 or C-151 sealed source. A maximum activity of 15.0 kCi is allowed for sources containing pellets. The standard head is designated for sources of up to 12,000 Rhm or approximately 13,400 Rhm with an optional source drawer containing an 8 inch (20.3 cm) or 8.5 inch (21.6 cm) uranium alloy (alloyed with 8% molybdenum and weighing 26.5 lbs (12.0 kg) or 27.9 lbs (12.7 kg); Model G9-140 or G22-140) or tungsten insert (Model G22-140A).
The source head assembly consists of a lead filled, cast steel shell 44.25 inches (1.13 m) long by 21 inches (53.3 cm) high by 24.25 inches (61 cm) wide secured to the arm by means of a rectangular steel casting. An unalloyed, depleted uranium or tungsten billet (enlarged May 1975) is located within the source head as part of the shielding for the "OFF" position. A 2.5 inch (6.4 cm) diameter by 21.5 inch (54.5 cm), brass encased, lead filled source drawer moves horizontally through a distance of 13 inches (33 cm) in 1.5 seconds by a pneumatic system linked to the source drawer. Alternatively, a uranium filled source drawer
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (CORRECTED PAGES 1, 4& 8)
HQ1 NR-687-D-105-S DATE: May 21, 1999 PAGE: 3 OF 9 DEVICE TYPE: Teletherapy Unit DESCRIPTION (cont'd):
(Model G9-140 or G22-140) or tungsten filled source drawer (Model G22-140A) may be used.
Precise alignment of the source drawer and beam defining light, located at the front end of the drawer, is ensured by guide pins attached to the ends of the drawer which mate in U grooves located at the two extreme end positions.
The teletherapy source is held in the source cavity by a source sleeve, tungsten or depleted uranium plus a 8% molybdenum alloy plug and a retaining ring. The pneumatic system is designed through the use of relays, solenoids, valves, and sensing switches so that the drawer automatically retracts to the "OFF" position in the event of power failure or loss pressure. A lead
]
steel auxiliary shield was added May 1975 in front of the source '
drawer to prevent streaming.
The lead and depleted uranium (both alloyed and unalloyed) or tungsten collimation assembly defines a field size which can be varied from a 3.5 cm square at 31.5 inches (80 cm) from the source (about 240 maximum subtended angle). The unit comes equipped with the 17.7 inch (45 cm) SDD collimator trimmer bars as a permanent attachment. The 21.7 and 25.6 inch (55 and 65 cm) trimmer bars are attached with screws to the 17.7 inch trimmer bars.
The head will swivel through 359' and does not angle forward or backward. Beam orientation can be limited by two mercury switches.
Lights on the source head and on the control panel indicate the "On" and "Off" positions. A fluorescent red-tipped rod extends approximately 5 inches (12.7 cm) through the front end of the unit top head cover and mechanically indicates the source position. The source drawer retracts to the "Off" position when the pneumatic prescure drops, power fails, or the treatment room door is opened; the unit must then be reset at the control panel to continue treatment. Alarms on the unit (bell or buzzer) and at the control console (high frequency tone) sound off when the unit is first turned on, if an emergency push-button is
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (CORRECTED PAGES 1, 4& 8)
HQ1 NR-687-D-105-S DATE: Fby 21, 1999 PAGE: 4 OF 9 DEVICE STPE: Teletherapy Unit DESCRIPTION (cont'd):
depressed, or if the treatment table collision detector operates.
In emergency, the source drawer can be mechanically pushed to the "Off" position by use of an emergency T-bar.
The unit can contain uranium shielding as follows:
Source head Billet (Unalloyed depleted U-238) - 203 lbs Source head Primary Definer (unalloyed depleted U-238) -
17 lbs Collimator Trimmer Bars (45, 55, 65 cm)
(unalloyed depleted U-238) -
12 to 16 lbs Beam Shaping Block (U-238 alloyed with 8%
molybdenum) -
12 lbs Round Uranium Source Drawer (U-238 alloyed with 8% molybdenum) -
27 lbs 300 lbs max The Theratron 780 series consists of five device types the 780, 780C, T780E, Phoenix and Elite 80. The difference between the units lie primarily in the peripheral equipment. The 780C differs from both the 780 and Phoenix in that is has dual timers instead of a single timer. The dual timer on the console measure time by monitoring source drawer position and movement time. Any difference in the preset variance time will cause the drawer to be returned to the shielded position.
The 780C and the Phoenix have the following components that differ from the 780.
. A detent pin has been provided with the T-Bar to allow locking of the source drawer in the shielded position.
. The penumbra trimmer will be tungsten instead of depleted uranium.
. The filter rails / beam shaping rails assembly has been modified to allow a greater distance to the table top and provide for easier loading of beam shaping equipment.
. Patient set-up controls are located on the overhead unit and on a hand control unit.
i REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (CORRECTED PAGES 1, 4& 8)
NO: NR-687-D-105-S DATE:May 21, 1999 PAGE: 5 OF 9 DEVICE TYPE: Teletherapy Unit DESCRIPTION (cont'd):
The Phoenix has the following components that differ from both the 780 and 780C models.
. The head swivel is not a standard feature, instead the !
collimator is permanently directed at the isocenter. If the head swivel is supplied as an option it will be manual driven.
- The collimator, x, y, and rotation drives are manually driven. Also the Phoenix has directly driven mechanical scales in place of electronic readouts.
The Model T780E includes modifications that enable this model to meet, in addition to the specifications for the other models, the provision of the International Electrotechnica. "ammission 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 l " 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, j interlocks, and external connections.
l The Model Elite 80 includes the design features of the Model i T7802 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 730 Series.
The control system of the Elite 80 teletherapy unit is equipped with electronic operator controls with respect to the push-bottom style controls used on the Model 780 series. Functionally, the two control systems are identical.
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE l (CORRECTED PAGES 1, 4 & 8)
ND1 NR-687-D-105-S DATE: thy 21,1999 PAGE: 6 OF 9 DEVICE TYPE: Teletherapy Unit LABELING:
l Each source holder is identified by stamped characters 0.09 in.
high x 0.01 in. (2.3 mm X 0.25 mm) maximum depth with the l pertinent source drawer serial number. The drawer is also l identified on both end faces in characters 0.09 in high x 0.01 in. deep (2.3 mm X 0.25 mm) with the inscription " CAUTION-RADIOACTIVE MATERIAL - URANIUM." The source housing is labeled in j accordance with 10 CFR 20.1904.
1 DIAGRAM:
See Attachments 1 and 2.
CONDITIONS OF NORMAL USE:
The Model 780 Series Teletherapy Unit is designed for use in hospital or clinic environments for the treatments 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 i
used to surround the treatment area. Considering the shielded room environment in which the device is used, the probability of severe conditions including accidents and fires is small.
EXTERNAL RADIATION LEVELS:
The manufacturer has determined that the head can be loaded with up to 12,000 Rhm with a normal source drawer or approximately 13,400 l I
Rhm with a steel encased source drawer containing uranium or tungsten shielding. The average dose rate readings taken from points around the device do not exceed 2 mR/hr (0.2 Sv/hr) and at no point exceeds 10 mR/hr (1 Sv/hr). Small areas of reduced protection, however, are acceptable in evaluating the maximum i exposure rate providing the average over 100 square centimeters at l one meter from the source does not exceed 10 mR/hr (1 Sv/hr). The device meets the requirements stated above according to the National Council on Radiation Protection (NCRP) No. 33 4.2.2. The Model T780E also meets the International Electrotechnical Commission Standard IEC 601-2-11, 1987. The Model Elite 80 meets the International Electrotechnical Commission Standard IEC 601-2-11, Second Edition 1997.
l l
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES j SAFETY EVALUATION'OF DEVICE (CORRECTED PAGES 1, 4 & 8) 4 HQ1 NR-687-D-105-S DATE: Fby 21, 1999 PAGE: 7 OF 9 DEVICE TYPE: Teletherapy Unit 0,UALITY ASBURANCE AND CONTROL:
Theratronics International Limited maintains a quality assurance and control program which has been deemed acceptable for licensing purposes by NRC. A copy of the program is on file with NRC.
LIMITATIONS AND/OR CONSIDERATION OF USE:
The Theratronics International Model Theratron 780 Series Teletherapy Unit shall be distributed only to persons specifically licensed under 35.600 10 CFR Part 35 by the Nuclear Regulatory Commission or under equivalent regulations of an Agreement State.
The device shall be leak tested at six (6) month intervals using techniques capable of detecting 0.005 Ci (185 kBq) of removable contamination.
. The device shall be installed and initially tested for proper operation of the source exposure mechanism, safety warning components, labels, external radiation-levels (source exposed, source shielded) and leak tested by the manufacturer or other persons specifically licensed by the Nuclear Regulatory Commission or an Agreement State.
. 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 recommended by Theratronics International every 5 years or at source replacement.
- The device shall be installed and initially tested for proper operation of the source exposure mechanism, safety warning components, labels, external. radiation-levels (source exposed, source shielded) and leak tested by the manufacturer or other persons specifically licensed by the Nuclear Regulatory Commission or an Agreement State.
i s
I REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (CORRECTED PAGES 1, 4& 8)
NQ1 NR-687-D-105-S DATE: Fby 21, 1999 PAGE: 8 OF 9 DEVICE TYPE: Teletherapy Unit LIMITATIONS AND/OR CONSIDERATION OF USE (cont'd)
. The dual timer, introduced with the Theratron 780-C is authorized to be used ca a replacement timer for Theratron 780 units in service.
The field units are to be modified so that the operation of the dual therapy timer remains as specified in product specification G85-281, Section 2.1, submitted February 13, 1985.
- REVIEWER NOTE: The device is designed for a maximum activity of 13,400 curies when the standard lead source drawer is used. The unit may be licensed for up to 15,000 curies when any of the Models G9-140, G22-140 and G22-140A optional source drawers are used.
l
- REVIEWER NOTE: The NRC expects and encourages that maintenance be performed in accordance with the procedures and schedules contained in the user's manual provided by the manufacturer.
l e This registration sheet and the information contained within the references shall not be changed without the written consent of the Nuclear Regulatory Commission.
SAFETY ANALYSIS
SUMMARY
l l
Based on our review of the Theratron 780 Series and Elite 80, and the information and test data cited below with this amendment which corrects the maximum activity levels and source outputs, we continue to conclude that the Theratronics International Model Theratron 780 Series and Elite 80 Teletherapy Unit designs are acceptable for specific licensing purposes.
1 Furthermore, we continue to conclude that this device would be expected to maintain its containment integrity for normal conditions of use and accidental conditions which might occur during uses specified in this certificate.
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REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES l ' SAFETY EVALUATION OF DEVICE l
(CORRECTED PAGES 1, 4 & 8) l l HQ1 NR-687-D-105-S DATE: May 21, 1999 PAGE: 9 OF 9 l
DEVICE TYPE: Teletherapy Unit
REFERENCES:
The following supporting documents for the Theratron 780 Series l
and Elite 80 Teletherapy Units are hereby incorporated by l reference and are made a part of this registry document.
l l . AECL's letters dated May 18, 1972, July 17,1975, May 15, 1975, July 22, 1976, August 17,1977, February 13, 1985, May 9, 1985, October 21, 1985, and August 12, 1986 with enclosures thereto.
. Theratronics International Limited's letters dated November'17, j 1992, August 20, 1991, August 9, 1991, February 6, 1989, 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.
Submission of Theratronics International Limited QA Manual with letter dated September 29, 1997, with enclosures thereto.
. Theratronics International Limited's letters dated July 17, l 1998, November 9, 1998, December 11, 1998, and February 15, 1999, with enclosures thereto.
ISSUING AGENCY:
U. S. NUCLEAR REGULATORY COMMISSION DATE: Nby 21. 1999 REVIEWER: ; A fohn P.YJankovich, Ph.D.
~
DATE: May 21, 1999 CONCURRENCE: O' Ujagar , achu, P.Eng.
1
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (CORRECTED PAGES 1, 4& 8)
NO: NR-687-D-105-S DATE: thy 21,1999 ATTACHMENT: 1 OF 2 1
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REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (CORRECTED PAGES 1, 4& 8)
NO: NR-687-D-105-S DATE: May 21, 1999 ATTACHMENT: 2 OF 2 Ap!Llatt mlh
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Mr. C. D._ Beatty, Regulatory Affairs May 21, 1999 Thsratronics International, Ltd.
'- '413 March Street P.O. Box 13140 Kanata, Ontario, Canada K2K 287 l
Dear Mr. Beatty:
Based on the information submitted in your email dated April 9,1999, we have corrected the typographical errors pertaining to registration certificates Nos. NR-687-D-101-S and NR-687-D-105-S. Thank you for bringing these errors to our attention. The certificates with the corrections are enclosed. '
Please be advised that you must manufacture and distribute the product in accordance with the statements and representations contained in your application, with enclosures thereto, and the information set out in your registration certificate. As a general rule, you must request and obtain l an amendment to the certificate before you make changes or modifications to the information submitted to obtain the certificate.
l Please read over the registration certificate in its entirety and notify us immediately if there are any errors or omissions.
You are obligated to notify us promptly in writing should you decide to no longer manufacture or l offer service support for the product.
l Please be aware that, as a holder of an NRC registration certificate, you may be subject to the NRC's licensing fees in accordance with 10 CFR Part 170, and annual fees in accordance with 10 l CFR Part 171. If you have any questions concerning the fee requirements, please contact the License Fee and Debt Collection Branch at (301) 415-6096.
If you have any questions, please contact me at (301) 415-5799 or Dr. John Jankovich at (301) 415-7904.
Sincerely, 3
Eric B. Compton, Engineering Aide Material Safety and Inspection Branch Division of Industrial and Medical Nuclear Safety Office of Nuclear Material Safety l and Safeguards
Enclosures:
As stated cc w/ encl: SKimberley, LFDCB Distribution:
SSSS r/f SSD-99-30 NE01b SSD File # NR-687-D-101-S SSD File #NR-687-D-105-S DOCUMENT NAME: H:\ERIC\COMPLTR\NR68710X.cor To receive a copy of this document. Indicate in the box: "C' = Copy without attachment / enclosure "E" = Copy with attachment / enclosure 'N' = No copy OFFICE MSIB C # SIB ifV C NAME ECompton f'C JJankof cW DATE 5/3 /99 5/ 3 /99' OFFICIAL RECORD COPY 9 ?J3oiSOO it - If .
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REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEV'CE (CORRECTED PAGES 1 & 7)
NO.- NR-687-D-101-S DATE: May 21, 1999 PAGE 1 OF 8 DEVICE TYPE: Teletherapy Unit MODEL: T1000, T1000E and Elite 100 l
MANUFACTURER / DISTRIBUTOR:
Theratronics International, Ltd (formerly Atomic Energy of Canada, Ltd.)
413 March Road P.O. Box 13140 Kanata, Ontario, Canada K2K 2B7 SEALED SOURCE MODEL DESIGNATION:
Theratronics Model C-146 or Model C-151 ISOTOPE: MAXIMUM ACTIVITY:
1 Cobalt-60 15,000 Curies (555 TBq) l Depleted Uranium 231 pounds (105 kg) l LEAK TEST FREOUENCY- 6 Months l
l PRINCIPAL USE: (C) Medical Teletherapy CUSTOM DEVICE: YES X NO i l
l l
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REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (CORRECTED PAGES 1 & 7)
NO.- NR-687-D-101-S DATE: Fhy 21, 1999 PAGE 2 OF 8 DEVICE TYPE: Teletherapy Unit DESCRIPTION:
The Theratron T1000, T1000E, and Elite 100 are rotational teletherapy units with the head and beam stopper on a "C" arm 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 shie'd within the source head. The units may have one of three di'ferent bases (tables).
The base with table Model 73 or Model 73M 1r 54 x 64 inches (137 x 162.6 cm). The base for Model 23T is 50 x 39 inches (127 x 251.5 cm).
The cobalt-60 sealed source is placed and secured with a 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) source to diaphragm distance. The source to diaphragm distance can be reduced to 17.7 inches (45 cm) by removing the trimmers,
I REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE I (CORRECTED PAGES 1 & 7) I NO.- NR-687-D-101-S' DATE: Fby 21, 1999 PAGE 3 OF 8 DEVICE TYPE: Teletherapy Unit DESCRIPTION { cont'd)-
with a field size varying from 2.5 to 17.2 inches !
(6.3 to 43.7 cm). i 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 l
"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 source position.
In the event of an interruption to the electrical power, the I source will automatically withdraw to the "OFF" position. In case of an emergency the source can be placed in the "OFF" I 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 l 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.
The source exposure mechanism is inspected and serviced during source exchanges or at intervals not exceeding 5 years. This 3 time period corresponds to approximately 40,000 on/off cycles. l 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 l
r REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE I (CORRECTED PAGES 1 & 7)
NO.- NR-687-D-101-S DATE: bby 21, 1999 PAGE 4 OF 8 l DEVICE TYPE: Teletherapy Unit DESCRIPTION (cont'd):
l " Beam On" and " Beam Off" positions. In order to accommodate the l additional shielding in the therapy head design, the geometry of ;
i the primary definer was also changed. Regarding electrical '
controls, modifications were made in gantry fault monitoring, interlocks, and external controls.
l l The Model Elite 100 includes the design features of the Model I
, T1000E and meets the provisions of the International l l Electrotechnical Commission Standard IEC 601-2-11, Second Edition '
l 1997. Meeting the provisions of IEC 601-2-11, Second Edition l
1997, resulted in interchanging the x and y field size parameters of the position indicators with respect to the Model 1000 Series.
l The control system of tha Elite 100 teletherapy unit is equipped l
with electronic operator controis with respect to the push-bottom style controls used on the Model 1000 series. Functionally, the l two control systems are identical.
1 LABELING:
. Each uranium component is permanently labeled with " CAUTION, l RADIOACTIVE SHIELDING URANIUM". In addition, radiation caution l plates with the radiation symbol and the words " CAUTION i RADIOACTIVE", or " CAUTION RADIOACTIVE MATERIAL" are permanently attached to the source head and cabinet. Additional labels l contain the manufacturer's name and the device model number.
l DIAGRAM: l See attachments 1, 2, and 3.
l 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. l Shielding in the form of poured concrete or lead is typically I used to surround the treatment area. Considering the shielded
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVTCE (CORRECTED PAGES 1 & 7)
NO.: NR-687-D-101-S DATE: Fby 21, 1999 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.
The device is expected to be subjected to approximately 40,000 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 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 j the requirements of Canadian Standards Association Standard C22.2 No. 114-1980, and the National Council on Radiation Protection l (NCRP) 33.
EXTERNAL RADIATION LEVELS:
l The manufacturer has determined that the head can be loaded with f 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/hr (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 I above according to NCRP 33 4.2.2. The Model T1000E meets the
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (CORRECTED PAGES 1 & 7)
NO.: NR-687-D-101-S DATE: Phy 21, 1999 PAGE 6 OF 8 DEVICE TYPE: Teletherapy Unit EXTERNAL RADIATION LEVELS (cont'd)-
International Electrotechnical Commission Standard IEC 601-2-11, 1987. The Model Elite 100 meets the provisions of the International Electrotechnical Commission Standard IEC 601-2-11, Second Edition 1997.
OUALITY ASSURANCE AND CONTROL:
Theratronics International Limited maintains a quality assurance and control program which has been deemed acceptable for licensing purposes by NRC. A copy of the program is on file with NRC.
LIMITATIONS AND/OR OTHER CONSIDERATIONS OF USE:
Theratronics Model T1000 and T1000E Teletherapy Units shall be distributed only to persons specifically licensed under 35.600 10 CFR Part 35 by the Nuclear Regulatory Commission or under equivalent regulations of an Agreement State.
. The device shall be installed and initially tested for proper operation of the source exposure mechanism, safety {
warning components, labels, external radiation levels
]
(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 recommended by the manufacturer every 5 years or at source replacement.
. The device shall be leak tested at intervals not to exceed six (6) months using techniques capable of detecting 0.005 microcuries (185 kBq) of removable contamination.
1
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REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (CORRECTED PAGES 1 & 7)
NO.- NR-687-D-101-S DATE: Phy 21, 1999 PAGE 7 OF 8 DEVICE TYP,0: Teletherapy Unit LIMITATIONS AND/OR OTHER CONSIDERATIONS OF USE (cont'd)-
REVIEWER NOTE: The applicant must demonstrate compliance with Subpart-I, 10 CFR Part 35 (in particular Section 35.615) before a license can be issued.
REVIEWER NOTE: The NRC expects and encourages that maintenance be performed in accordance with the procedures and schedules contained in the user's manual provided by the manufacturer.
The user can perform mai,ntenance on the device only as provided in the Model T-1000, T1000E, and Elite 100 operation manual.
This registration sheet and the information contained with the references shall not be changed without the written consent of the NRC.
SAFETY ANALYSIS
SUMMARY
Based on our review of the Theratronics' Model T1000, T1000E and Elite 100 Teletherapy devices and the information and test data 1 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 I 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 9, 1991, August 20, 1991, and November 17, 1992, and telefaxes dated February 13, 1990, and March 28, 1990, with enclosures thereto.
I i
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (CORRECTED PAGES 1 & 7)
NO.- NR-687-D-101-S DATE: Fby 21, 1999 PAGE 8 OF 8 DEVICE TYPE: Teletherapy Unit REFERENCES (cont'd)-
Theratronics International Limited's letters dated November 1, 1996, November 24, 1997, December 12, 1997, with enclosures thereto.
Submission of Theratronics International Limited QA Manual with letter dated September 29, 1997, with enclosures thereto.
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 DATE: May 21, 1999 REVIEWER:
Jdhn P. Jahkovich, Ph.D.
DATE: May 21, 1999 CONCURRENCE:
Ujagar S iachu, P.Eng.
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REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES l SAFETY EVALUATION OF DEV"E (CORRECTED PAGES 1 & 7) l 1
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NO.- NR-687-D-101-S DATE: May 21, 1994 ATTACHMENT 3
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Mr. C. D. Bratty, R::gulatory Affairs May 21, 1999 Thsratronics Int::rnational, Ltd.
413 March Street P.O. Box 13140 '
Kanata, Ontario, Canada K2K 287
Dear Mr. Beatty:
Based on the information submitted in your email dated April 9,1999, we have corrected the typographical errors pertaining to registration certificates Nos. NR-687-D-101-S and NR-687-D-105-S. Thank you for bringing these errors to our attention. The certificates with the corrections are enclosed.
Please be advised that you must manufacture and distribute the product in accordance with the statements and representations contained in your application, with enclosures thereto, and the information set out in your registration certificate. As a general rule, you must request and obtain an amendment to the certificate before you make changes or modifications to the information submitted to obtain the certificate.
Please read over the registration certificate in its entirety and notify us immediately if there are any errors or omissions.
You are obligated to notify us promptly in writing should you decide to no longer manufacture or offer service support for the product.
Please be aware that, as a holder of an NRC registration certificate, you may be subject to the NRC's licensing fees in accordance with 10 CFR Part 170, and annual fees in accordance with 10 CFR Part 171. If you have any questions concerning the fee requirements, please contact the License Fee and Debt Collection Branch at (301) 415-6096.
If you have any questions, please contact me at (301) 415-5799 or Dr. John Jankovich at (301) 415-7904.
Sincerely, 3
Eric B. Compton, Engineering Aide Material Safety and Inspection Branch Division of Industrial and Medical Nuclear Safety Office of Nuclear Material Safety and Safeguards
Enclosures:
As stated cc w/ encl: SKimberley, LFDCB :
Distribution: .
SSSS r/f SSD-99-30 NE01 !
SSD File # NR-687-D-101-S SSD File #NR-687-D-105-S ,
DOCUMENT NAME: H:\ERIC\COMPLTR\NR68710X.cor J Ts receive a copy of this document, Indicate in the box: "C" = Copy without attachment / enclosure "E" = Copy with attachment / enclosure "N" = No copy P
OFFICE MSIB 1ASIB \fV lC l l l NAME ECompton f'C JJankohcW DATE 5/3 /99 5/ 3 /99" OFFICIAL RECORD COPY
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEu'CE (CORRECTED PAGES 1 & 7)
NO.. NR-687-D-101-S DATE: May 21, 1999 PAGE 1 OF 8 DEVICE TYPE: Teletherapy Unit MODEL: T1000, T1000E and Elite 100 MANUFACTURER /DISTRIEUTOR:
Theratronics International, Ltd (formerly Atomic Energy of Canada, Ltd.)
413 March Road P.O. Box 13140 Kanata, Ontario, Canada K2K 2B7 SEALED SOURCE MODEL DESIGNATION:
Theratronics Model C-146 or Model C-151 ISOTOPE: MAXIMUM ACTIVITY:
Cobalt-60 15,000 Curies (555 TBq)
Depleted Uranium 231 pounds (105 kg)
LEAK TEST FREOUENCY: 6 Months PRINCIPAL USE: (C) Fedical Teletherapy CUSTOM DEVICE: YES X NO M&53ST!-h iIll
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (CORRECTED PAGES 1 & 7)
NO.:.NR-687-D-101-S DATE: thy 21,1999 PAGE 2 OF 8 DEVICE TYPE: Teletherapy Unit DESCRIPTION:
The Theratron T1000, T1000E, and Elite 100 are rotational teletherapy units with the head and beam stopper on a "C" arm 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 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 co111mation 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) source to diaphragm distance. The source to diaphragm distance can be reduced to 17.7 inches (45 cm) by removing the trimmers,
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (CORRECTED PAGES 1 & 7)
NQ.; NR-687-D-101-S DATE: May 21, 1999 PAGE 3 OF 8 DEVICE TYPE: Teletherapy Unit DESCRIPTION (cont'd)-
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 i backward. Beam orientation is limited by two mercury switches. l 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 source 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.
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 '..ne specifications for the other model, the provision of tle 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
l l
I REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES l SAFETY EVALUATION OF DEVICE l (CORRECTED PAGES 1 & 7) i l NO.- NR-687-D-101-S DATE: Phy 21, 1999 PAGE 4 OF 8 i 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 !
l Electrotechnical Commission Standard IEC 601-2-11, Second Edition l l 1997. Meeting 'ne provisions of IEC 601-2-11, Second Edition i
1997, resulted in interchanging the x and y field size parameters of the position indicators with respect to the Model 1000 Series.
l The control system of the vlite 100 teletherapy unit is equipped with electronic operator ccutrols with respect to the push-bottom l style controls used on the Model 1000 series. Functionally, the l two control systems are identical.
LABELING:
Each uranium component is permanently labeled with " CAUTION,
- RADIOACTIVE SHIELDING URANIUM". In addition, radiation caution l
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.
pIAGRAM:
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
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DE"'CE (CORRECTED PAGES 1 & 7)
NO.: NR-687-D-101-S DATE: Eby 21,1999 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.
The device is expected to be subjected to approximately 40,000 On/off cycles between source changes.
PROTOTYPE TESTING:
The main difference between the T1000, T1000E, and Elite 100 models with respect te 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 hate been taken. The device is 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/hr (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 above according to NCRP 33 4.2.2. The Model T1000E meets the
4 REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (CORRECTED PAGES 1 & 7)
NO.- NR-687-D-101-S DATE: Fby 21, 1999 PAGE 6 OF 8 DEVICE TYPE: Teletherapy Unit EXTERNAL RADIATION LEVELS (cont'd)-
International Electrotechnical Commission Standard IEC 601-2-11, 1987. The Model Elite 100 meets the provisions of the International Electrotechnical Commission Standard IEC 601-2-11, Second Edition 1997.
OUALITY ASSURANCE AND CONTROL:
Theratronics International Limited maintains a quality assurance and control program which has been deemed acceptable for licensing purposes by NRC. A copy of the program is on file with NRC.
LIMITATIONS AND/OR OTHER CONSIDERATIONS OF USE-Theratronics Model T1000 and T1000E Teletherapy Units shall be distributed only to persons specifically licensed under 35.600 10 CFR Part 35 by the Nuclear Regulatory Commission or under equivalent regulations of an Agreement State.
The device shall be installed and initially tested for proper operation of the source exposure mechanism, safety warning components, labels, external radiation levels (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 recommended by the manufacturer every 5 years or at source replacement.
The device shall be leak tested at intervals not to exceed six (6) months using techniques capable of detecting 0.005 microcuries (185 kBq) of removable contamination.
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (CORRECTED PAGES 1 & 7)
NO.- NR-687-D-101-S DATE: Pby 21, 1999 PAGE 7 OF 8 DEVICE TYPE: Teletherapy Unit LIMITATIONS AND/OR OTHER CONSIDERATIONS OF USE (cont'd)-
REVIEWER NOTE: The applicant must demonstrate compliance with Subpart-I, 10 CFR Part 35 (in particular Section 35.615) before a license can be issued.
REVIEWER NOTE: The NRC expects and encourages that maintenance be performed in accordance with the procedures and schedules contained in the user's manual provided by the manufacturer.
The user can perform maintenance on the device only as provided in the Model T-1000, T1000E, and Elite 100 operation manual.
This registration sheet and the information contained with the references shall not be changed without the written consent of the NRC.
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 9, 1991, August 20, 1991, and November 17, 1992, and telefaxes dated February 13, 1990, and March 28, 1990, with enclosures thereto.
l*
l REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (CORRECTED PAGES 1 & 7)
NO.: NR-687-D-101-S DATE: May 21, 1999 PAGE 8 OF 8 DEVICE TYPE: Teletherapy Unit I
REFERENCES (cont'd)
Theratronics International Limited's letters dated November 1, 1996, November 24, 1997, December 12, 1997, with enclosures thereto.
Submission of Theratronics International Limited QA Manual with letter dated September 29, 1997, with enclosures thereto.
Theratronics International Limited's letters dated July 17, 1998, November 9, 1998, December 11, 1998, and February 15, 1999, with enclosures thereto.
ISSUING AGENCY:
U.S. NUCLEAR REGULATORY COMMISSION DATE: May 21, 1999 REVIEWER:
JdNn P. Ja'nkovich, Ph.D.
DATE: May 21, 1999 CONCURRENCE:
Ujagar S achu, P.Eng.
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REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEV'"E (CORRECTED PAGES 1 & 7)
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NO.- NR-687-D-101-S DATE: May 21, 1999 ATTACHMENT 3
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p Mr. C. D. Beatty, Regulatory Affairs Flay 21, 1999 Theratronics International, Ltd.
!- 413 March Street P.O. Box 13140 Kanata, Ontario, Canada K2K 2B7 l
Dear Mr. Beatty:
l Based on the information submitted in your email dated April 9,1999, we have corrected the l typographical errors pertaining to registration certificates Nos. NR 687-D-101-S and -
NR-687+D-105-S. Thank you for bringing these errors to our attention. The certificates with the corrections are enclosed.
Please be advised that you must manufacture and distribute the product in accordance with the statements and representations contained in your application, with enclosures thereto, and the information set out in your registration certificate. As a general rule, you must request and obtain an amendment to the certificate before you make changes or modifications to the information submitted to obtain the certificate.
Please read over the registration certificate in its entirety and notify us immediately if there are any errors or omissions.
You are obligated to notify us promptly in writing should you decide to no longer manufacture or offer service support for the product.
Please be aware that, as a holder of an NRC registration certificate, you may be subject to the NRC's licensing fees in accordance with 10 CFR Part 170, and annual fees in accordance with 10 ,
CFR Part 171. If you have any questions concerning the fee requirements, please contact the
{
License Fee and Debt Collection Branch at (301) 415-6096.
If you have any questions, please contact me at (301) 415-5799 or Dr. John Jankovich at (301) 415-7904.
Sincerely, h
Eric B. Compton, Engineering Aide Material Safety and Inspection Branch ;
Division of Industrial and ]
Medical Nuclear Safety 1 Office of Nuclear Material Safety l and Safeguards ;
Enclosures:
As stated I
cc w/ encl: SKimberley, LFDCB Distribution:
SSSS r/f SSD-99-30 NE01b SSD File # NR-687-D-101-S SSD File #NR-687-D-105-S DOCUMENT NAME: H:\ERIC\COMPLTR\NR68710X.cor To receivi e copy of this document, Indicate in the box: *C' = Copy without attachment / enclosure "E" - Copy with attachmentfenclosure "N" . No copy P # SIB ifV l,_
- OFFICE MSIB C
! NAME ECompton f'C JJankof cW l DATE 5/ 3 /99 5/ 3 /99' OFFICIAL RECORD COPY
-490T&6/ /- //'
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (CORRECTED PAGES 1 & 7)
NO.: _NR-687-D-101-S DATE: May 21, 1999 PAGE 1 OF 8 DEVICE TYPE: Teletherapy Unit i MODEL: T1000, T1000E and Elite 100 4
MANUFACTURER / DISTRIBUTOR: I Theratronics International, Ltd (formerly Atomic Energy of Canada, Ltd.)
413 March Road P.O. Box 13140 Kanata, Ontario, Canada K2K 2B7 SEALED SOURCE MODEL DESIGNATION:
Theratronics Model C-146 or Model C-151 ISOTOPE: MAXIMUM ACTIVITY:
1 Cobalt-60 15,000 Curies (555 TBq)
Depleted Uranium 231 pounds (105 kg)
LEAK TEST FREOUENCY: 6 Months PRINCIPAL USE: (C) Medical Teletherapy CUSTOM DEVICE: YES X NO
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REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (CORRECTED PAGES 1 & 7)
NO.- NR-687-D-101-S DATE: May 21, 1999 PAGE 2 OF 8 )
DEVICE TYPE: Teletherapy Unit DESCRIPTION:
The Theratron T1000, T1000E, and Elite 100 are rotational teletherapy units with the head and beam stopper on a "C" arm 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.
l l
The units are designed to treat at a source-to-axis distance 1 (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 i patient through an angle of up to 35 from the central ray. The l 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 l 251.5 cm).
l The cobalt-60 sealed source is placed and secured with a ,
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. J 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 l
source to diaphragm distance. The source to diaphragm distance can be reduced to 17.7 inches (45 cm) by removing the trimmers,
I -
l REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES l SAFETY EVALUATION OF DEuTCE (CORRECTED PAGES 1 & 7) l NO.- NR-687-D-101-S DATE: May 21, 1999 PAGE 3 OF 8 l DEVICE TYPE: Teletherapy Unit DESCRIPTION (cont'd)-
l with a field size varying from 2.5 to 17.2 inches l (6.3 to 43.7 cm).
l The head will swivel through 2 180 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 i
"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 tne source position.
In the event of an interruption to the electrical power, the i 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 1
1 L.
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (CORRECTED PAGES 1 & 7)
NO.- NR-687-D-101-S DATE: May 21, 1999 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 l the primary definer was also changed. Regarding electrical
! controls, modifications were made in gantry fault monitoring, '
l interlocks, and external controls.
l 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 i 1997. Meeting the provisions of IEC 601-2-11, Second Edition l
l 1997, resulted in interchanging the x and y field size parameters l l of the position indicators with respect to the Model 1000 Series. I The control system of the Elite 100 teletherapy unit is equipped l with electronic operator controls with respect to the push-bottom style controls used on the Model 1000 series. Functionally, the two control systems are identical.
LABELING:
Each uranium component is permanently labeled with " CAUTION, l RADIOACTIVE SHIELDING URANIUM". In addition, radiation caution !
l plates with the radiation symbol and the words " CAUTION I l RADIOACTIVE", or " CAUTION RADIOACTIVE MATERIAL" are permanently j l attached to the source head and cabinet. Additional labels l l contain the manufacturer's name and the device model number.
I 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
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (CORRECTED PAGES 1 & 7)
NQ. NR-687-D-101-S DATE: Fby 21, 1999 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.
The device is expected to be subjected to approximately 40,000 On/Off cycles between source changes.
PROTOTYPE TESTING:
l 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.
i For those units that are to be placed in high earthquake risk areas additional precautions have been taken. The device is bolted in a 10 inch (25.4 cm) deep pit by concrete anchors. The pit is then filled with high density concrete. I 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/hr (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 above according to NCRP 33 4.2.2. The Model T1000E meets the l
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE l (CORRECTED PAGES 1 & 7)
NO.- NR-687-D-101-S DATE: thy 21,1999 PAGE 6 OF 8 DEVICE TYPE: Teletherapybnit EXTERNAL RADIATION LEVELS (cont'd)-
International Electrotechnical Commission Standard IEC 601-2-11, 1987. The Model Elite 100 meets the provisions of the International Electrotechnical Commission Standard IEC 601-2-11, Second Edition 1997.
OUALITY ASSURANCE AND CONTROL:
Theratronics International Limited maintains a quality assurance and control program which has been deemed acceptable for licensing purposes by NRC. A copy of the program is on file with NRC.
LIMITATIONS AND/OR OTHER CONSIDERATIONS OF USE:
Theratronics Model T1000 and T1000E Teletherapy Units shall be distributed only to persons specifically licensed under 35.600 10 CFR Part 35 by the Nuclear Regulatory Commission or under equivalent regulations of an Agreement State.
The device shall be installed and initially tested for proper operation of the source exposure mechanism, safety warning components, labels, external radiation levels (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 recommended by the manufacturer every 5 years or at source j replacement. '
l .
The device shall be leak tested at intervals not to exceed i f six (6) months using techniques capable of detecting 0.005 microcuries (185 kBq) of removable contamination. l j
REGISTRY OF P.ADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (CORRECTED PAGES 1 & 7)
NO.: NR-687-D-101-S DATE: Fby 21, 1999 PAGE 7 OF 8 DEVICE TYPE: Teletherapy Unit LIMITATIONS AND/OR OTHER CONSIDERATIONS OF USE (cont'd)*
REVIEWER NOTE: The applicant must demonstrate compliance with Subpart-I, 10 CFR Part 35 (in particular Section 35.615) before a license can be issued.
REVIEWER NOTE: The NRC expects and encourages that maintenance be performed in accordance with the procedures and schedules contained in the user's manual provided by the manufacturer.
The user can perform maintenance on the device only as provided in the Model T-1000, T1000E, and Elite 100 operation manual.
This registration sheet and the information contained with the references shall not be changed without the written consent of the NRC.
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 9, 1991, August 20, 1991, and November 17, 1992, and telefaxes dated February 13, 1990, and March 28, 1990, with enclosures thereto.
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REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (CORRECTED PAGES 1 & 7)
NO.: NR-687-D-101-S DATE: May 21, 1999 PAGE 8 OF 8 DEVICE TYPE: Teletherapy Unit REFERENCES (cont'd)-
Theratronics International Limited's letters dated November 1, 1996, November 24, 1997, December 12, 1997, with enclosures thereto.
Submission of Theratronics International Limited QA Manual with letter dated September 29, 1997, with enclosures thereto.
Theratronics International Limited's letters dated July 17, 1998, November 9, 1998, December 11, 1998, and February 15, 1999, with enclosures thereto.
ISSUING AGENCY:
U.S. NUCLEAR REGULATORY COMMISSION pc /) ec # 4 '-
DATE: May 21, 1999 REVIEWER:
Jofin P. Jh'nkovich, Ph.D.
DATE: May 21, 1999 CONCURRENCE:
Ujagar S g chu, P.Eng.
l REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (CORRECTED PAGES 1 & 7)
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