ML20217H802
| ML20217H802 | |
| Person / Time | |
|---|---|
| Issue date: | 03/16/1998 |
| From: | Steven Baggett, John Lubinski NRC |
| To: | |
| Shared Package | |
| ML20217H801 | List: |
| References | |
| SSD, NUDOCS 9804060070 | |
| Download: ML20217H802 (5) | |
Text
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l REGISTRY OF RADIOACTIVE. SEALED-SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE
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PAGE 1 OF'4 NO.: NR-8101-D-802-S DAIE1 DEVICE TYPE:
Rotational Teletherapy Unit MODEL:
Toshiba RCR-120-C1,'RCR-120-C3
. MANUFACTURER / DISTRIBUTOR:
Litton Medical Products, Inc.
Profexray Division 515 E. Touhy Avenue Des.Plaines, IL 60018 l
SEALED SOURCE MODEL DESIGNATION:
GE Drawing 106D3949 ISOTOPE:
MAXIMUM ACTIVITY:
Cobalt-60 10,000 Ci (370 TBq)
T.RAK TEST FREOUENCY:
6 Months PRINCIPAL USE:
(C) Medical Teletherapy CUSTOM DEVICE:
YES X
NO c
9004060070 900316 P DR RC SSD PDR
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE PAG 2 OF 4 NO.: NR-8101-D-802-S DATE:
NMR 16 BM DESCRIPTION:
The Toshiba RCR-120-C1 was a rotational teletherapy unit with the head and beam catcher on a "C" arm which rotated about the patient.
The Toshiba RCR-120-C3 differed from the C1 in that it had a counterweight instead of a beam catcher.
The units came with a source-to-center of rotation distance of 80 cm (31.5").
The beam catcher subtended an angle of about 70 degrees from the patient and transmitted approximately 0.05% at the beam.
The unit was 7 feet 6 inches (2.29 m) high with a maximum source-floor distance of 6 feet 5 inches (1.96 m).
The distance between the source and back of the unit was approximately 8 feet 10 inches (2.69 m).
The unit was supplied with a standard head designated as "Toshiba C10."
This head consisted of a spherical cast steel shell filled with lead.
A tungsten alloy sleeve inside the head provided additional shielding in the "off" position.
A 1.9" (4.83 cm) in diameter by 8.3" (21.08 cm) long cylindrical source drawer made of tungsten alloy fitted horizontally into the lead turntable shutter.
The teletherapy capsule was held in the source cavity, which was 30 mm (1.182") in diameter by 34.5 mm (1.36") in height, of the drawer by a threaded cap and metal retaining hoop which were placed into position inside the hot cell.
The shutter rotated in a horizontal plane from the "on" position to the "off" position by an electric motor working against a torsion spring.
In case of power failure, the shutter would return automatically to the "off" position.
The tungsten allor co111mation assembly defined a field size which could be varied from 5 cm2 (0.77 in2) to 35 cm2 (5.42 in2) at 80 centimeters from the source.
-The head swiveled 165 in either direction and tilted 130 forward from the downward position and 30 back.
Beam orientation could be limited by electrical or mechanical stops.
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE NO.: NR-8101-D-802-S DATE:
kgg j g jggg PAGE 3 OF 4 DESCRIPTION (Cont'd)-
Lights on the unit and on the control panel indicated the "on" and "off" conditions.
The mechanical source position indicator was a drum attached to the shutter drive shaft and was viewed through a window toward the top of the teletherapy head cover.
Red color indicated beam "on" condition and green color indicated beam "off" condition.
The turntable shutter retracted to the "off" position by the return spring when the power failed or when the interlocked door was opened; the unit had to then be reset to continue treatment.
In an emergency, the shutter could be mechanically rotated to the "off" position by inserting an emergency bar in the slot on top of the teletherapy head and rotating couterclockwise 180 degrees.
EXTERNAL RADIATION LEVELS:
The manufacturer determined that the head could be loaded with 10,000 curies (370 TBq) of cobalt-60 with an output of 11,800 rhm and yield an average and a maximum radiation level at 1 meter from the source of 1.17 mrem /hr (11.7 Sv/hr) and 5.3 mrem /hr (53 pSv/hr), respectively, with the source in the "off" position.
Beam "on" leakage was less than 0.01%.
LIMITATIONS AND/OR OTHER CONSIDERATIONS OF USE:
As of the effective date of this document, the Models Toshiba RCR-120-C1 and RCR-120-C3 Rotational Teletherapy Units are no longer manufactured and distributed.
However, they may still be approved for licensing purposes.
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f REGISTRY.OF RADIOACTIVE SEALED / SOURCES AND DEVICES.
' SAFETY EVALUATION OF. DEVICE C 'NR-8101~D-802-S DATE:
^ MAR 161998 pAGE 4'op 4
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REFERENCES:
This' registration certificate supersedes NR-421-D-102-U dated December 15,-1971 and is based on information included in that certificate.
ISSUING AGENCY:
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l U.S. Nuclear Regulatory Commission MAR 161998 Reviewer:
Date:
John W.
Lubinski
-- Date:
Concurrence:
b 87 #
Steven L.
Baggett t
)
PAGE1 l
NRC FORM 567 U. 8. NUCLEAR REOULATORY COMMISSION De3)
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REQUEST FOR A SEALED SOURCE OR DEVICE EVALUATION l
INSTRUCTIONS: Send this request AND a copy of all related letters /appucates and drawings to: The Sealed Source Safety Sectwi, ATTN: Chief, OWFN Mail Stop 6 H3. Change the Ucense Tracking System maestone to 19 and seeign to rev6 ewer code I-5.
f NOTE: Retain a copy of this request with the appucation and background files.
REQUESTER REGION / LOCATION:
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A)
NY"r/,CA /
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11 111 IV RV R HQ U LFDCB TELEPHONE NUMaER DATE TYPE OF ACTION REQUESTED (Check as, w.L) e APeucAurs NAME SOURCE REVIEW AMENDMENT OF REGISTRATION SHEET Ma CourRot NUMsEa(S)
DEVICE REVIEW NUMBER (S) 1JR-p i ~i) ~ t 0 l' "
LETTER /AP%, TON DATE UcENSE NUMBER (S)
CUSTOM REVIEW A;/2 W A i - 7) - :O-A IIll9/GI jDeic egd'4y } v'.MJ 5~d E % Ay /Ib'E hs Pr,e s, D i nyd FOR SSSS USE OALY i
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MODEL NUMBERS NUMBER ASSONED DAfE'RECEn%D DATE ASSGNED
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DATE TO FEES I
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//b/ff i?l.kl9 7 TYPE OF ACTION (Wa Ilie number of each type)
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l COMMERCIAL DISTRIBUTION (FORMAL) l USE BY A SINGLE APPLICANT (CUSTOM)
SOURCE (9C)
DEVICE (9A)
SOURCE (90)
DEVICE (98)
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NEW
] NEW AMENDMENT v AMENDMENT AMENDMENT AMENDMENT M NO SAFETY EVALUATION REQUIRED j UCENSING ACTION REQUIRED IF KNOWN NO FEES REQUIRED NO j OTHER (Specey)
TOTAL NUMBER OF NOTES W#'
NU B R OF DEFICIENCY LETTERS NUMBER OF DEFICIENCY CALLS FOR BILLING FtARPOSES ONLY NAME CHANGE ADDRESS CHANGE J NEW REGISTRATION -
] PRODUCT INACTIVE-ADD TO BILLING REMOVE FROM BILLING FOR FEE USE ONLY ME OHEE FEE CATEGORY L,
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]9A 98 9C 90
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AMOUNT RECErVED L
CHECn NUMBER MATANN UPDATED p p+'
y AS REQUIRED I
DATE or mECn 5)-
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j MATSYS UPDATED 6
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AS REQUIRED
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