ML20206U054
| ML20206U054 | |
| Person / Time | |
|---|---|
| Issue date: | 02/23/1999 |
| From: | Bhachu U, Jankovich J NRC |
| To: | |
| Shared Package | |
| ML20206U022 | List: |
| References | |
| SSD, NUDOCS 9905250022 | |
| Download: ML20206U054 (11) | |
Text
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I REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE
( (AMENDED IN ITS ENTIRETY)
NO: NR-687-D-105-S DATE: Nb 2 3 333 PAGE: 1 OF 9 l DEVICE TYPE: Teletherapy Unit l
MODEL: Theratron 780 Series (780, 780C, i T780E, Phoenix, Elite 80)
MANUFACTURER / DISTRIBUTOR:
Theratronics International, Ltd.
(formerly Atomic Energy of Canada Ltd.)
413 March Road l P.O. Box 13140 l Kanata, Ontario, Canada K2K 2B7 l
l FEALED SOURCE MODEL DESIGNATION: AECL C-146 or C-151 l Theratronics C-146 or C-151 ISOTOPE: MAXIMUM ACTIVITY:
Cobalt-60 ' 5,000 Ci (555 TBq) w/ optional source l
,', drawer l 23,400 Ci (495. 8 TBq) w/ lead source drawer.
Depleted Uranium Shielding 302 lbs (137 kg) l LEAK TEST FREOUENCY: 6 months PRINCIPAL USE: (C) Medical Teletherapy CUSTOM DEVICE: YES X NO 9905250022 990521 PDR RC
- SSD PDR
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (AMENDED IN ITS ENTIRETY)
HR1 NR-687-D-105-S DATE: ffS 2 j ggg 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 unit's functions are motor operated and can be controlled from either a hand control located near the unit or a control cons 31e 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
1 l
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES I SAFETY EVALUATION OF DEVICE (AMENDED IN ITS ENTIRETY) 00u. NR-687-D-105-S DATE: IN 2 N3 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 I 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" j position in the event of power failure or loss pressure. A lead l steel auxiliary shield was added May 1975 in front of the source j 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 j source (about 240 maximum subtended angle). The unit comes
! equipped with the 17.7 inch (45 cm) SDD collimator trimmer bars l as a permanent attachment. The 21.7 and 25.6 inch (55 and 65 cm) l 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 l unit top head cover and mechanically indicates the source l position. The source drawer retracts to the "Off" position when !
the pneumatic pressure drops, power fails, or the treatment room i door is opened; the unit must then be reset at the control panel l to continue treatment. Alarms on the unit (bell or buzzer) and l at the control console (high frequency tone) sound off when the unit is first turned on, if an emergency push-button is l l
1 j
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (AMENDED IN ITS ENTIRETY)
NO: NR-687-D-105-S DATE: f f 8 2 3 $39 PAGE: 4 OF 9 DEVICE TYPE: 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 (Unall d depleted U-238) - 203 lbs Source head Primary De iner [ nalloyed depleted U-238) <
17 lbs Collimator Trimmer ar s (45 55, 65 cm)
(unalloyed deple ed U-23 -
12 to 16 lbs Beam Shaping Block (U-23 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 drewer position and movement time. Any dif ference in the preset variance time will cause the drawer to be returned to the shielded position.
The 780C and the Phoenix have the fo] lowing 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 l on a hand control unit.
l t
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I REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES l SAFETY EVALUATION OF DECCE (AMENDED IN ITS ENTIRETY)
NO: NR-687-D-105-S DATE: PAGE: 5 OF 9 l
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 permenently 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 l meet, in addition to the specifications for the other models, 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
" 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 connections.
The Model Elite 80 includes the design features of the Model T780E 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 780 Series.
l 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 t two control systems are identical. i f
I i
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES
, SAFETY EVALUATION OF DEVICE (AMENDED IN ITS ENTIRETY)
NQ1 NR-687-D-105-S DATE: B 2 3 GH PAGE: 6 OF 9 DEVICE TYPE: Teletherapy Unit LABELING:
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 pertinent source drawer serial number. The drawer is also 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 MATEF.IAL - URANIUM." The source housing is labeled in accordance with 10 CFR 20.1904.
DIAGRAM:
1 See Attachmerits 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 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.
E_XTERNAL 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 Rhm with a steel encased source drawer containing uranium or l 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 exposure rate providing the average over 100 rquare centimeters at 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 lO "
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE ;
(AMENDED IN ITS ENTIRETY)
NQ1 NR-687-D-105-S DATE: I N 2 3 199 PAGE: 7 OF 9 DEVICE TYPE: Teletherapy Unit .
I 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 l NRC.
LIMITATIONS AND/OR CONSIDERATION OF USE: l The Theratronics International Model Theratron 780 Series Teletherapy Unit shall be distributed only to persons i specifically licensed under 35.600 10 CFR Part 35 by the I 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 l 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.
l
. 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.
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REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (AMENDED IN ITS ENTIRETY) f EB 2 31399 NO: NR-687-D-105-S DATE: 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 as 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.
- 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
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.
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 j during uses specified in this certificate. j I
I
REFERENCES:
l f
The following supporting documents for the Theratron 780 Series and Elite 80 Teletherapy Units are hereby incorporated by reference and are made a part of this registry document.
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (AMENDED IN ITS ENTIRETY) i NO: NR-687-D-105-S DATE: FEB E l :339 PAGE: 9 OF 9 l DEVICE TYPE: Teletherapy Unit 4'
REFERENCES (cont'd):
. 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.
l
. Theratronics International Limited's letters dated November 17, 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, 1998, November 9, 1998, December 11, 1998, and February 15, 1999, with enclosures thereto.
ISSUING AGENCY:
U. S. NUCLEAR REGULATORY COMMISSION DATE:
(( 2 2 .1 sp REVIEWER: d
/) v t ed g/ohn P.00 ankovich, Ph.D.
DATE: CONCURRENCE: p -
U chu, P.Eng.
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NO.: NR-687-D-105-S DATE: ATTACHMENT 1 l
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Theratron 780 Sourcehead
PAGE1 NRC FORM 567 U. S. NUCLEAR REGULATORY COMMISSION REQUEST FOR A SEALED SOURCE OR DEVICE EVALUATION
~ $Y .
INSTRUCTIONS: Send this request AND a copy of all reisted letters /applicehons and drawings to: The Seeled Source Safety Section. ATTN: Chief, OWFN Meu Stop 6 H3. Change the License Tracking System milestone to 19 and seeign to revlower code I-5.
NOTE: Retain a copy of this request with the application and back0round flies.
J OUESTER '
REGION / LOCATION:
/
TELEPHONE NUMBER t'd *r()()/C 3 lI ll R lil IV V R HQ R LFDCB DATE TYPE OF ACTION REQUESTED (Check as - o, e)
APPUCA 6NAME yg hgh/ SOURCE REVIEW AMENDMENT OF REGISTRATION SHEET MAIL CONTROL NUMdiR(S) / DEVICE REVIEW N BE p
LETTER / DATE UCENSE NUMBER (S) CUSTOM REVIEW A/M-[8 7- O- /dT ~3 COMMENTS.
N N 4/B /?? arch 5freef 740 26X /3/40 Oron bA r 01 A n tikff l AY kbY FOR SSES USE ONLY REVIEWER .
MODEL NUMBERS [/ CO Up 7/ @6 NUMBER AS$1GNED k/ C DATETECENE C6@7DM 6/[Ye / On ,T/kmben Weh S m DATE ASSIGNED DATE TO FEES N-AO TYPE OF ACTION (Indicate the number of each type) l COMMERCIAL DISTRIBUTION (FORMAL) l USE BY A SINGLE APPLICANT (CUSTOM)
SOURCE (9C) DEVICE (9A) SOURCE (90) DEVICE (98)
^
NEW NEW NEW NEW AMENDMENT AMENDMENT AMENDMENT AMENDMENT NO SAFETY EVALUATION REQUIRED j LICENSING ACTION REQUIRED IF KNOWN -
NO FEES REQUIRED NO j OTHER (Specity)
TOTAL NUMBER OF NOTES j j p REVIEW HOURS @grec((Or) $ f')F f* G E G TDr '
NUMBER OF DEFICIENCY LETTERS A bg gg heOfCe RPy[ b hOnS NUMBER OF I b/7M ! Cm e G4L DEFICIENCY CALLS FOR BILLING PURPOSES ONLY NAME CHANGE ADDRESS CHANGE j NEW REGISTRATION - ] PRODUCT INACTIVE -
ADD TO BILLING REMOVE FROM BILLING FOR FEE USE ONLY TYPE OF FEE FEE CATEGORY CMOUNT RECENED J C41tf 3c -
]9A U 98 BC 9D h CHECK NUMBER
- MATANN UPDATED k _
AS REQUIRED DATE OF CHECK LOG
( ) .b(/.) j TSYS PDATED V' " #
GPPROVED BY DATE RETURN DATE V !
NRC FORM S67 (843)
,. , &M - - - -