ML20055F479

Package of Registries of Radioactive Sealed Sources & Devices for GA-645-S-101-S,GA-688-D-101-S & NR-687-D-101-S

ML20055F479
Person / Time
Issue date:	06/06/1988
From:	NRC
To:
Shared Package
ML20055F476	List: ML20055F475 ML20055F479
References
FOIA-90-299 NUDOCS 9007170214
Download: ML20055F479 (27)

Text

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REGISTRY OF RADI0 ACTIVE SEAJED SolTRCES ~ AND DEVICES SAFETY EVALUATION OF-SEAIID SOURCE (Amended in its entirety) 3 CA645S1015 DATE:

June 6, 1988 PACE:

1 of 8 i

SEALED SOURCE TTPE:

Sealed brachytherapy source 3

MODEL1 200 (Old Model No. 100) l

_MA MTFACTURER/DI STRIBUTOR:

Theragenics. Corporation 900 Atlanta Drive,LN.W.-

Atlanta, Georgia 30318 i

ISOTOPE:

Pall.2dium-103 MAXIMUM ACTIVITY:

Not to exceed 10 millicuries each-i.-

(

)

_1.EAK TEST FREQUENCY:

i l'

l' PRINCIPLE USE:

General Medical'Use

.i CUSTOM SOURCEt.

TES X

N0

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CUSTOM OSER:

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9007170214 900709 m

PDR FDIA.

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e REGISTRY OF'RADI0 ACTIVE SEALED SOURCES AND DEVICES-SAFETY EVALUATION OF SEALED SOURCE (Amended in its entirety)

NO: CA645510lS DATE:

June'6; 1988-PACE:-2 of.8-i I

SEALED SOURCE TYPES-Sealed brachytherapy source I

f DESCRIPTION:

The Model 200 Palladius' Seed consists of a cylindrical titanium tube sealed at both ends with laser velded' titantus end, cups.' ; Enclosed in the tube'. are two palladium-103 plated graphite cyltaders. and - 4 lead rod 1 X-ray. markerito identify the position-of implanted seeds on ~ a. radiograph.

The = cylindrical-tube is 0.177 inch - (4.5 U_]

in overall length f and 0.032 inch - (0. 81 mm) - in diameter.

All of the titanium material is coc:me rcia11y. pure ASTM B265-78, Crade 2.

The lead-and; graphite are both 99.99*T. pure.

The radioactivei pa11adium-103 is: electrolytically plater, upon all. outer surface of 'the graphite substrate.

I IABELINC:

The size of the !! ode l 200 Palladiuto Seed precludes. any engraved. etched for-printed labeling.

The seeds will be shipped in :a--small vial inside a lead-vial. holder.

The lead vial = holder.will. be'.placed inside. _ Labeling that 'will.

be af fixed-to each of these' containers are illustrated, in Figures 1,

2, ; 3, and 4.

4 i

DIACRAM:

Figure five shows the material of construction, dimensions, method of sealing,

f and the relationship of all major components for the Model 200 palladiurs Seed.

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c RECISTRY OF RADI0 ACTIVE SEA.IED SOURCES.93 DEVICE $

SATETY EVALUATION'OF SE' LED SOURCE (Amended in its entirety) rio n_

CA64551018

,DATE:

June 6, 1988' PACE: 3 of 8

(

J SEALED SOURCES TYPEt, Sealed brachytherapy source CONDITIONS OF NORMAL USE:

. The Model 200 Palladium Seed is intended to be used as 's permanent ' interstitial

' implant.

The soft therapeutic X-ray (20-23 kev) emitted by the Palladium Seed interact with the tissue to be treated.

Palladium Seeds are indicated for tumore with the following characteristics:

o Localized o Unresectable 7

o Low to moderate radiosensitivity

-. i The tumors may be of the following types o Superficial o Intrathor cic o Intraabdominal o Lung, Pancreas, Prostrate (Stage A or B) o Residual following external radiation o Recurrent l.

The seeds are designed to withstand temperatures and pressures: up to 272'F' (133'c) and 30 psig for 30 minutes.

Nominal autoclaving conditions, are 250'F (121'c) at 15 psis for 15 minutes.

.The seeds are capable. of withstanding -

4 moderate to severe challenges-to their. integrity.

-It ' is possible. through -

rough handling, high temperatures or crushing ' that = a. seed could leak or be ruptured.

If such an occurence does happen, th'e ra is little or. no biological hazard due to the non-toxic nature and' physical foria of the. internal components.

PROTOTYPE TESTUNlI The Palladius goods were subjected to four prototype tests to ' demonstrate their integrity under expected ' stresses-of use f or 1 accidents.

These tests provided evaluation.under ' the following conditions:

1) Autoclaves. 2) Impact,.

-t

3) Percussica -and 4) Band.

The tests were conducted generally.as suggested in NBS Handbook 126,. ANSI H542-1977 - Appendix. C 'and ANSI -N44.1-1973.

Brachytherapy seeds containing Pd-103 sealed - in a ' cube of dimensions as shown in figure 5 do not entirely fit the classifications or Definitions 'in > the referenced ANSI. s tandards.

Some - modifications of the. test conditions - were

. required.

These prototype tests for the Model 200 Palladium Seed follow closely the modified ANSI prototype tests that were performed by the 3M* Company for their. approved I-125 Seeds'.

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i REGISTRY OF.RADI0 ACTIVE SEALED SOURCES A!!D DEVICES SAFETY EVALDATION OF SEALED SOURCE (Amended in its entirety)

No CA6l.5S 1015 -

DATE:

June 6, 1988 PACE:

t. of 8

~

i SEALED SOURCE TYPE:

Sealed brachytherapy source EXTERNAL RADIATION /LEVEIJ:

llodel 200 Average Dose Rate-(mR/br)

$_eed Activity at 5 cm at 30 co-t 0.5 met (comp) 25.86 0.718 5.0 mci (Comp 258.60 7.180 QUALITY ASSURANCE AND CONTROL:

The major quality control tests that are used include the; following:

After Completion of Seed Assembly-Visual inspection to verify proper seating of the t i tan' Lura and cups in the titanium tubes and verify overall seed integrity.

Af ter Laser Welding Visual optical inspection to check cleanliness; and soundness of velds and verify overall seed integrity.

Dimensional checks performed to verify that the seeds are within specifications.

X-ray to verify the seed was loaded correctly..

Af ter Irradiation i

Autoclave leat tiikat perforised to verify no leakage of radioactive. palladium.

The radiation activity level of each seed, is measured using.a Capintec - Dose Calibration apparatus or, equivalent so seeds of the same Curie level can

-be grouped.together.

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ioll E REGISTRY'0F RADI0 ACTIVE SEALED SOURCES Af?D DEVICES l

~ SAFETT EVALUATION OF SEALED SOURCE

/

a (Amended in its entirety)'

t NO:

CA6k",P 015 DATE: June'6, 1984 Pacts 5 of 8 SEALED SOURCE TYPE:'

' Sealed brachytherapy source IIMITATIONS AND/OR OTHEE ~ CONSIDERATIONS OF USE:

A.

Palladium seeds are licensed; by the State' of Georgia for distribution te persons Itcensed ' pursuant - to (9)(c) and. (2)(c) of Chapter 290-5-23, Schedule C,

C oup VI, or under _ equivalent licenses - of the 'U.S.

Nuclear.

Regulatory Commtssion,'an Agreement State orLa 1.icensing State..

B.>

The seeds will be

1007, leak te'sted by thei manu fac tu rer : prior to distribution.

No further leak; testing is, necessary due to the: 16 '. 9 7 d ay half-life.-

C. -- The vial should. remain. in the lead pig. during storage. ' When - transporting seeds within the hospital, an appropria'te carrier with adequate ~ shielding should be used.

t D.

Adequate-radiation' protection should be used'during' implantation procedures, l:

however. in many instances in-surgery, radiation' protective barriers are-l not-practical, thus the medic'al personnel must rely upon; speed and distance to minimize radiation exposure.

E.

The titanium encapsulation provides very good - biocompatibility_ along with excellent corrosion resistance but it is not designed to be used in a

'i concentrated acid-environment:due to the chemical. reaction.

F.- The use of Palladium Seeds, as with other brachytherapy sources, is-- not recommended <for ' the-treatment of tumors ' in generally ~. poor-or ulcerated-condition.

G.- The radiomative Palladium Seeds are not. sterile when shipped.. hence a sterilizatish process must be performed.

Sterilization'may be accomplished by eitheir ethylene ~ ' oxide (Eto) or by. steam (autoclave) l prior' to-implantation.

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REGISTRY OF RADI0 ACTIVE SEALED SOURCES AND DEVICES

^

' SAFETY EVALUATION OF' SEALED SOURCE (Amended in its entirety) l l

l NO s_.

CA645S101S DATE:

June 6, 1988 PAC'E :

6 of 8 l

L SEALED SOURCE TYPE:

Sealed brachytherapy source t

I SAFETY ANALYSIS

SUMMARY

' We Model, 200 Palladium Seeds were subjected to Autoclave. Impact,. Percussion, and Be-1 tests to iverify their ' structural integrity - under both normal and-abnormal usage.. 'ne-seeds successfully passed these tests lwhich generally follow ANSI N524-1977 ANSI N44.1-1973 and ANSI N44.2-1973.

The Model 200 Palladium Seeds should not' be subjected to temperaturesigreater than lF. (13 3'C) or ' pressures. greater than 30 pais.

Under the abnornal

-conditions of fire or explosion, these conditions undoubtedly will be: exceeded.

Failure or rupture ' of a seed could permit ' release of.the palladium pellets.

l This physical form of the radioactive content. of' the seed ~ has ' no tendency l:

to pulverize into airborne respirable. particles --(see ANSI N44.1-1973,:Section 5.2).

Release of Pd-103 as a ' vapor is considered very remote.

As a memher of the platinum group of metals, it has a characteristically lov vapor: pressure of 1.6X 10-4 atm. at its melting point of 2826*F - (1550'C).

Chemically,- the palladium. is insoluble in water.

Although not designed for a concentrated i

~ a acid environment, it is only slightly attacked by sulfuric - and-hydrochloric i

acids.

In the event of' seed failure when implanted -in - the l body tissue, it has been shown that palladium is biocompatible.'

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RECISTRY OF RADI0 ACTIVE SEALED SOURCES Al(D DEVICES i

SAFETY EVALUATION OF SEALED. SOURCE No s_

CA645S1018 DATE: LJune 6, 1988 PACE,7 of 8 SEALED SOURCE TTFE _

Scaled brachytherapy source

REFERENCES:

This Certificate of Registration is based on information and test data contained in the following supporting documentsLvhich are hereby incorporated by reference and made a part of this ' registry document:

' 1.

Hilaris, B.S..

ed.Handb'ook of Interstitial Brachytherapy.

Publishing:

J Sc ience s : Crou p, Inc., Acton MA. 1975.

2.

NCRP Report No.

37 NCRP Publication, P.

O.

Box 30175, Washington, DC 20014.

'3.

NCRP Report No. '40 - NCRP Publication.

P.

O.

Box 30175.. Washington, DC 20014 4.- NCRP Report No. 41 NCRP Publication, P.

O.

Box 30175 Washington, DC

.20014 5.

NCRP Reporr, No. 48 NCRP Publication, P.O. Boa 30175, Washington, DC 20014 6.

NCRP Report No. 49 NCRP Publication.

P.O.

Box 30175, Washington, DC 20014 l

7.

Ling, C. Proceedings of Fourth International Conference 'on A dical Physics, Ottava, Canada ~, July 1976.

8.

Harper, Paul V. and Lathrop " Palladium-103 se Therapeutic'Radiatien Source" Nuclear Medicine.-Stuttgart, P.R.C.,

1965.:

9.

Theragenics Corporation application dated March 3.

1986 and enclosures thereto.

i 10.

Let ter - from Theragenics Corporation dated - March. 5, 1986 and enclosures thereto.

11.

Letter free Theragenics Corporation dated July 3, 1986.

12.

Letter from Theragentes Corporation dated March 15, 1988 and enclosure thereto.

13.

Letter from Theragenics Corporation dated March 21, 1988.

(

14.

Letter from Theragenics Corporation dated May 13, 1988 and enclosures thereto.

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REGISTRY OF RADI0 ACTIVE SEALED SOURC?S AND DEVICES L

. SAFETY EVALUATION OF SEALED SOCTRCE' 1.

i

~

(Amended inLtes-entirety)

NO: CA645S101S DATE:

June 6, 1988 PACE:

8 of 8 i

SEALED SOURCE TYPE:~

Sealed brachytherapy source ISSUING ACENCT:

Georgia Department of Human Resources

[

Radiological Health Section-DATE:

b - d - 88 REVTEWER:

81 M-u l

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DATEi d*b 8I CONCURAD CE:

AtAu (4/, 7j[ad L

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fptygsibin'g/cgf Apkj Q y

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17edi'onuclide Elrechytherapy Source Total Apparent Ap'tivity-mci l

comp.

3 Surface Dose Rate m Rgm/h r.

Assay Date Total No. Of Vials Total No. Of Seeds ':-

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This Fioduct Made in U.S.A. Of Theragenics Corpot'otion Atlanta, Ga. 30318 e....u. em. c mn w

- l

'(3) Outer Container i

-a. 5 g

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Il$!'.l'!.!![$IN'.lI!OhE:{l3/)3/(l!)[E

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!'40 Atlantic Driva,14.V1, - P.O. Box 94035:

Atlanta, Georgia Ps0318 t

...g (4) Cardbox Bos-

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5ABWO!V iG/c/rG q g ;$ f e k f.x +

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i N.'Y...0.b..$.\\UUA0.0CS$:5b.&'.'h'$N$'

C Radionuclide E3rechythempy Source Toini Apparent Ac~tivity mci t

o,

- comp.

Surface Dose Rate m Rgm/h r.

l Assap' Date j

Total No. Of Vials Total No. Of Seeds'-

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This Product t

Made in U.S.A. 0y:

Ther:3Genics corporation Autanca, Ga. 30318 c

..s.,xi.,,n.m x

'(3) Outer Container

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-i< ;sg 4 r-lU I(It!!I[$I;iN, S hs O 3 Y.) 3/-Yl'l _ll,d 000 Atlantic Driva, N.V1. - P.O. Box 94035 Atlanta, Georgia 30318 I

• }'

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l (4) C.ardbox Boz

= -..

vicunr. s-Titantun. End Cup p (.030'L X.028'D.- X-.002't.)

Pd. plated graphite : pellet f

g

(.036'L. X.023'D) l-i Laser < weld seal

~15 - C j

r)

!' l i- -

Titanium Tube

' Lead:X-Ray Marker j>

(.177'L1 X.032'0D ' X.0022't.)--

(.039'l. X.020'D)

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0.17 7' l

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3 REGISTRY OF RADIOACTIVE SEALED SOURCFS AND DEVICE -

SAFETY EVALUATION OF DEVICE EL: - CA 6880105 DAU:

December. 13 1989 ragg:

1 og 7

.c

-DEVICE TYPE:

Steaa Quality Monitoring' System

.a MODEL: Model 1

.i DISTRIBUTOR:

i Tundra, Division of AECL. Inc.

5251 Office Park Drive, Suite 401 Bakerafield, CA 93309 MANUFACTURER:

l'

[

Atomic' Energy of Canada Limited,. Inc., gg 344 Slater Street, Ottawa, KIP 549, Canada 9

SEALED SOURCE MODEL DESIGNATION:

L Isotope. Products ~ Labs, Inc. Model 327 or Amersham Corporation Model-(VN.3 and CVN.4 l

ISOTOPE:

Californium 252 a

MAXIMUM ACTIVITY:

One millicurie-i MAK TEST FREOUENCY:

6 Months s

PRINCIPAL USE:

(H) Ceneral Neutron Source Application CUSTOM DEVICE:

YES X NO 4

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RECISTRY OF RADI0 ACTIVE SEALED SOURCES AND DEVICE t

SAFETY EVALUATION OF DEVICE EL:

CA 68SD101S DAU:

December 13, 1989 ZAGE:

2 of 7 DEVICE TYPE:

Steam Quality Monitoring System 7

DIERIPTION:

The Steam.. Quality-Monitoring System consists of a Neutron Beam Extractor (NBE), a Data Acquisition Processor E(DAP), a custom pipe climb.with which i

these are mounted on a steam pipe and'other ancillary components.

The NBE;is-assembled from a welded aluminium housing which is lined with. cadmium for additional shielding.

The -cast. aluminium - end cape- 'are secured with camper resistant allen bolts, removable only by personnel who have a special i

key.

As ~ the NBE contains no moving ' parts and..isi not field serviceable, the key'will not be suppli6d to TUNDRA's customers.

~

The Neutron Beam Extractor (NBE) includes the following'sub assemblies:-

The encapsulated neutron source l's - enclosed in a stainless steel tube'.

The tube is filled with solid polyethylene and is screwed. into 's threaded hole machined in the moderator bulk.

The-moderator -bulk solid polyethylene surrounds the source tube and fills the. aluminium container.

A ' collimator tube which is 2" in diameter -is bored into the ? moderator: bulk.

The neutron source is centrally located within the polyethylene moderator, when not in use the beam port is directed towards the steam pipe..

j The data ' Acquisition. Processor- (DAP) Lis-mounted ldirectly opposite ' the beam' port.

The LAP consists - of the neutron detector, a microprocesser and-associated electronics, a

1ABELINC:

. These devices are labeled in.accordance ve:h Section' 30278 of: the California Radiation Cont'rol Regulations-(equivalent a 10 CFR 20.203).

The Neutron Beam Extractor, has two metallic labels on ~ each end 3"..by-4" in size stating

" CAUTION RADIOACTIVE MATERIAL".

The device also ; has a label showing the manufacturer's address, model and serial number.

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REGISTRY OF RADIOACTIVE SEALED SOURCES AND. DEVICE SAFETY EVALUATION OF DEVICE 11,:

CA 688D101s DAII:

December 13, 1989._

2AgI:

3.og 7 t

i DEVICE TYPI:

Stean Quality Monitoring System ~

4 a

DIACRAM:

+

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. *** 's F' n***'

(

COMPUTER MODULE l

' TERMINAL

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& Dis #4y Ui,,,6 Dewetor '

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cofrenator Pamkr a envi w Tube

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. NEUTRON BEAM BTRACTOR 1

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.sg s-l REGISTRY OF RADI0 ACTIVE SEALED SOURCES AND DEVICE SAFETY EVALUATION OF DEVICE E:

CA' 6 88D1013 -

DATI: December 13, 1989-FAgg: - 4 or 7 DEVICE TYPJ:

Steam Quality Monitoring System DIACRAM:

l 9

Threaded Statalese

- Steel Containment Tube

He vtron uurce, Cailferntum.252 ;

ebciend in a steel pellet i

C

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Neutron Sum port

' l,**" "'"i " "" --

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d

,,. -,,.e 3

\\ w::: :o Thrnded hele for

)-

- Polgothylene-6:

a unie % enitae Moderator NBC O -

-NSE exterior middle

.[.

vertteel tob

. housing (aluminum)-

/

. war too, Thrndeo heln for tamper-resistent

--f u I

Allen belta -

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7 ad C Temper-rs:(4 tant K y

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alien 6eit.

Neutron Beam Extractor l

y

-(NBE)

?

NBEI. oft Maln ComOonents "O

Thermecouple cobte connuter t

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.g REGISTRY OF RADICACTIVE SEALED SOURCES AND DEVICE SAFETY EVALUATION OF DEVICE

@: CAfgSD101S DAIE:

December 13, 1989 ZAq1:

5 of 7 i

l DEVICE TYII:

Steam Quality Monitoring System

-t CONDITIONS OF NORMAL USE:

These_ devices are used tio. measure steam properties in-thermal heavy oil

~

recovery projects utilizing neutron ; attenuation technology.

All work Lis performed in an open environment in designated areas.

PROTOTYPE TESTINC:

The manufacturer contends that

~

since-the Neutron Beam Extractor includes no moving parts, - life cycle testing is not relevant.

However, 'six? prototypes were built in early 1988 and' have undergone continuous bench - testing since that time.

The assessment on the INSICHT System was. performed with respect to Type A. container requirements specified in 49 CFR Part 173.401.:. No s o the r prototype testing material was provided by. the manufacturer.

t.

EXTERNAL RADIATION L'VELS:

The device is designed for radiat, ion levels at one meter from. the surface not '

to exceed over 0.2 mR/hr. per. mil 11 curie -'of Californium 252.

~ The i dose rate (mR/hr) measured at the' collimator position for all.0 millicurie source is as -

follows:

e Neutron Dose Camma Dose

' Combined Dose At 5 cm '

12.0-

'6.0' 29.8 At 30 cm 2.5 0.5 7,08 At 100 cm.

<0.25

<0.20

<1.06i j

OUALITY jdiSURANCE AND CONTR_QL:

i

.AECL Inc.

(TUNDRA' division) will. check for conformance to theLdevice

(

dimensional specifications and ; dose rat.e specifications as defined in' their application.

A11 ' operational modes will' be verified at' time of installation.

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REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICE SAFETY EVALUATION OF DEVICE' CA 688D10 %

DAIE:

December 13, 1989 PAGE:

6 of 7 DEVICE TYPE:. Steam Quality honitoring Systes 1

LIMITATIONS AND/OR OTHER CONSIDERATIONS OF USE:

i.

4 1.

These devices shall be distributed 'only to. specific licensees of the NRC or Agreement States.

i L

2.

Installation, initial. testing and survey; training,- maintenance and repair-I shall be performed _ by AECL, manufacturer or distributor. Inc. _ or. persons specifically trained by the 1

l 3.

Dismantling and relocation shall be performed by AECL, Inc. or by persons.

specifically trained by the manufacturer or' distributor.

4 Disposal _ or transfer ~ shall be only to AECL, Icc.

t specifically licensed by' the NRC or agreements states 'to = dispose' of or ar to persons receive the device.-

5.

The device shall be tested for leakage _ and' proper functioning c of the on/off mechanism' by AECL, Inc. at time of installation. -

be conducted at intervals not to exceed-6 months by AECL, Inc. or person Leak tests shall specifically licensed to do so by the NRC.or Agreement States.

test shall be capable of-de tecting 0.005 mic' ocuries 1. : of-removable The leak contamination.

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REGISTRY OF RADICACTIVE SEALED SOURCES AND DEVICE i

E l;

SAFETY EVALUATION OF DEVICE

[

i: CA 6880101S DATI:

December 13, 1989-EAGI:

7 of 7 DEVICE TYPE:

Steam Quality Monitoring System i

i i

SAFETY ANALYSIS

SUMMARY

h i

F Based on our review of the information and test data cited below, we cone.lude that,the Model 1, Steam Quality Monitoring System is acceptable for licensing i

purposes.

Furthermore, we conclude ' that this device 1would be expecced to 3

maintain its containment integrity,- for normal conditions

'.of.

use -and 1

l accidental conditions which might occur during uses specified in-this

. certificate.

REFERENCES:

This certificate of Registration is. based on.information and test-data contained.in the following, documents which -are hereby incorporated' by reference and made a part of this registry document.

1 A. 'AECL Inc. application dated April 7, 1989, signed by Dave Parker.

I B.

AECL Inc.

letters. with attachments received November 6,

1989, December 5, 1989 and December 19 1989. all. signed by Dave Parker, C.

AECL Inc. letters with attachm'ents dated-February 23,1990, March 5,- 1990 and March 16 1990, all. signed by Dave Parker.;

D.

NBS Handbook No. 129

" ANSI N,538" Classification of-Industrial Ionizing Radiation Cauging device).,

1977.

1 s

DATE:

Net rch

.30, '/190 -

REVIEWED BY: _ '-

b-d 1

b, l N' DATE:

I CONCURRENCE:

• /

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y ISSUING AGENCY:

California Department'of Health: Services j

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REGISTRY.OF RADIOACTIVE SEALED SOURCES AND DEVICES-SAFETY EVALUATION. OF DEVICE (AMENDED):

EL_i, NR-687-D-101-S gI PAGE 1 OF 7 Anq t gg 2

]

DELICE TYPE:

' Beam Therapy Device i

MQDXLi T1000 a

\\

\\

'MARQTACTURER/DISTRIARTRR1 Theratronics-Internationa1 I

,413 March Road.

P.O. Box 13140-

-Kanata, Ontario,. Canada. K2K2B7

~ HEALED SOURCE MODEL DESIGNATIONl-Theratronics Model C-146 1

and

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=

Model C-151 ll ISOTOPE:

MAXIMUM' ACTIVITY:

. Cobalt-60

.15,000:Cories Depleted Uranium 231.: pounds j

1 i

~ !

LEAK TEST'FREOUENCY:

6 Months 1

t' PRINCIPAL 13SE:

(C)' Medical Tel'etherapy

. i

.QUSTOM DEVICE:

YES

-x No 1

r 4-L I

REGISTRY OF RADIOACTIVE SEALED SOURCES AND' DEVICES SAFETY. EVALUATION OF DEVICE (AMENDED)

NO..:

NR-687-D-101-S DATE:

. APR 18 1990 PAGE 2'OF 7 i

DEVICE TYPE:

Beam Therapy Device i

DESCRIPT.LQHi The Theratron-T1000' is.a-rotational teletherapy unitLwith:the head and beam barrier on'a "C" arm 4 which rotates about the r

patient. -Functionally,'it is identical ~to-the Theratron 780C

-except'that-it has a stretched' arm (100 cm: source'to axis.

distance) and hand controls-supported by' overhead beams instead of the controls mounted on the. head.

It can'be operated'inffour modes; fixed,. rotational, arc,.and skip.

A. built-in?

~

beam-defining 71 amp 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,-orTa control; console located 4

outside the treatment room, r

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.The unit is designed to treat at.a source-to-axis distance (SAD)

L' of 100 cm and the' beam center line'positionfisiaccurate-to.within-t-1 mm. :A steel encased,' lead' filled. optical beam stopper l

attenuates 99% of the primary beam'and' reduces;by'the same factor radiation scattered by the patient through ancanglesof up-to 35o

-from the' central, ray. ETheLapproximate weight'of the unit is' i

13,000: pounds (5900 kilograms) and.overall height 11s.111 inches.

The unit contains up to 231. pounds of depleted uranium shielding-or may con'tain an optional; tungsten shield within the source

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' head. 1The unit may have.one'of:three different bases.(tables).

The base with table Model'73 orLModel'73M is'54-x 64 inches.

The i

base-for Model 23T is 50 x-99minches.

i The cobalt-60 sealed source ~1s'placed and secured /with'a a

stainless steel-retaining.rin~g in a lea'd filled, brass encased ~

L source: drawer.

The source drawer is attached to'a pneumatic-cylinder which allows horizontal. movement of-the sealed source.

The lead and. depleted uranium. (both alloyed and ' unalloyed) ~ or tungsten' collimation assembly defines a;fjeld size'which can be varied from:5--to 42.5-centimeters'(cm) for a'55'cm source to I

diaphragm. distance.

The sourcesto diaphragm' distance can be reduced-by. removing the trimmers to 451cm'with'avfield size varying from 6.'3 to 43.7 cm.-

i The head will' swivel through 1800 and does not angle forward or T

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REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF-DEVICE 4

' ( AMENDED) t EQ21 NR-687-b-101-S DATE:

4 2 AGE 3 OP'77 QEVICE TYPE:_

Beam Therapy; Device

'i DESCRIPTION (CONT.):

backward.-

switches.

Beam orientation.can be limited by two mercury n

Lights on the sourceheadLand on:the control panel indicate the i

"On" and "Off" positions.

A~ fluorescent red-tipped rod extends approximately 5 inches through the front end_of the. unit top head 4

i cover and mechanically indicates the source position.

L In the event of an interruption to the-electrical power, the source source will automatically withdraw:to the "OFF" position.

In cace of an emergency ~the source can:placed;in the "OFF" position by an operator pushing the Emergency Off Switch.

this fails, If.

"Off" position byLuse of an-emergency T-bar.the. source drawer can be Alarms on the unit (bell or buzzer) and at the control console if an emergency (high' frequency tone) sound!off when:the unit is firstl turned table collision pushbutton is. depressed,.or if the treatment detector operates.-

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The device has dual timersJ monitoring source drawer position.and movementttime. fAny'on the co differences-in the preset var!ance= time:will cause the drawer.to

-l be returned'50 the shielded position.

The source exposure mechanism is inspected Land serviced'during source exchanges or at intervals.not exceeding 5-years.

This.

time period corresponds-to approximately;40,000 On/off. cycles.

JABELING : -

a Each uranium component is permanently labeled with " CAUTION, RADIOACTIVE SHIELDING URANIUM".

The source capsule is engraved with:the manufacturer's logo, isotope,Emodel' number, serial number, and the radiation symbol.

In addition, radiatir

aution plates with~the radiation symbol and the words "CAUTIO.. RADIOACTIVE",

or." CAUTION RADIOACTIVE

. MATERIAL"are permanently attached to-the source? head'and cabinet.

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APR 181990 EQ21 NR-687-D-101-S DATE1 PAGE 4 OF 7 l

DEy1RE TYPE!_

Beam Therapy Device

~i DlhGBAML See attachments 1, 2, and 3.

CONDITIONS OP NORMAL USE_

The Model T1000 Teletherapy Unit is designed for use in hospital linic environments for the treatment of patients with cancer oi j

conditions of use include a clean but 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, including accidents and fires is small.the probability of severe conditions 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.

EBOTOTYPE TESTING The main difference between the T1000 and the 780-C is the extended arm.

i Stress calculations by direct measurements of arm deflection were performed by the manufacturer.

i The results showed less than 1 millimetsr of deflection.

For those units that are to be placed in high earthquake risk areas additional precautions hLve been teken.

The device is bolted.in a 10 inch deep pit by concrete anchors.

then filled with high density concrete.

'The pit is t

The manufacturer certifies that Model C-146, and C-151 will meet I

the ANSI classification E46425 by comparison with Model C-165 and performance of impact tests, use since 1968 with no reported l incidents.The sealed sources-have'been in The T-1000 was also found to comply with the requirements of.

Canadian Standards Association Standards C22.2 No.

0-1982, and C32.2 No.

144-1980, and NCRP 33.

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REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (AMENDED)

HQ2:

NR-687-D-101-S DATEt AFR !3 fM0 PAGE 5 OF 7 DEVICE TYPE:

Beam Therapy Device EXTERNAL RADIATION LEVELS!

The manufacturer has determined that the head can be loaded with up to 15,000 curies of cobalt-60.

taken from points around the device do not excesd 2 mR/hr and noThe average point exceeds 10 mR/hr.

Small areas of reduced protection however, are acceptable in evaluating the maximum exposure, rate providing the average over 100 square centimeters at one' meter from the source does not exceed 10 mR/hr.

The device meets the requirements stated above according to the National Council on Radiation Protection (NCRP) no.33 4.2.2.

QUALITY ASSURANCE W_ CONTROLt Theratronics International's (formerly AECL) Quality. Assurance Program has been previously deemed acceptable by the NRC.

Theratronic's sources are used throughout hospitals = worldwide.

No radiation incidents due to capsule failure have been reported to date.

k LIMITATIONS AND/02 OTHER CONSIDERATIONS OP USE:

]

Theratronics Model T1000 Teletherapy Unit shall be o

distributed only to persons specifically~ licensed by the-NRC under Section 35.600, 10 CPR Part 30. or.under equivalent provisions in an Agreement State, The device 'shall be installed and initially. tested -for-o warning components, proper operation of the source exposure.machanism, sa labels, external' radiation' levels (source exposed, source shielded manufacturer or other persons spe)cifica).ly' licensed byand. leak te 5

the NRC or an Agreement State.

Handling, storage, use, transfer, and disposal To be-o 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.

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(AMENDED)

M921 HR-687-D-101-S DATE:

APR !8jgg PAGE 6 0F_7_

DEVICE TYPE:

Beam Therapy Device LIMITATIONS AND/OR OTHER CONSIDERATIONS OF USE (cont.):

The device'shall be leak tested at six (6) month o

4 intervals using techniques capable of detecting 0.005 microcuries of removable contamination.

o REVIEWER NOTE:

The applicant must demonstrate compliance with Section 35.600, 10 CFR Part 35 in particular Section 3B.615 before a license can,be issued.

The user can perform certain maintenance on the device (see the Model T-1000's operation manual).

This registration sheet and the information contained o

I with the references shall not be changed without the written consent of the NRC.

SMETY ANALYSIS

SUMMARY

Based on our review of the Theratronics' Model T1000 Teletherapy device and the information and test data cited below, we conclude to conclude that this device is acceptable for specific licensing purposes.

1 Furthermoye, 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.

REFERENCES _t_

The following supporting documents for the Model T1000 Teletherapy device are hereby incorporated by reference and are l

made a part of this registry document, i

o_ Theratronics' application dated June 21, 1989, and i

enclosures thereto, Theratronics' letters dated February 19, 1990, February o

19, 1990, and telefax dated February 13, 1990, with enclosures thereto.

o.

Theratronics' telefax received March 28,.1990.

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SAFETY EVALUATION OF DEVICE (AMENDED) f H h' t.NR-687-D-101-S-DATEt APR 1. 8 1990 PAGE 7 0F 7 i

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