BrachyTherapy - 700 Harris Street

Suire 109

USA re1 + l 434 977 8495 fix + I 434 244 7181

VA R i A N i chariorresvliir, VA 22x13

medica l s y s t e m s

www.varim.com

October 11,2007

Document Control Desk U.S. Nuclear Regulatory Commission Washington DC 20555

Re: Written Notification for 10 CFR 21 Report

Varian Medical Systems, Inc. is submitting this Written Notification based on the potential applicability of 10 CFR 21 to an event involving a High Dose Rate Afterloader that occurred at City of Hope Hospital in Duarte. California on July 15.2007. Facsimile notication was sent to the USNRC on September 17,2007.

This correspondence is being submitted in compliance with 10 CFR 2121(d)(3)(ii) and contains complete information that is related to the event.

If necessary, please contact me at (434) 951-8675, or email to rick.oiccolo@varian.com.

Richah G. Piccolo. CHP Varian Brachytherapy RSO

Copy: Regional Administrator USNRC, Region I 475 Allendale Road King of Prussia, PA 19406-1415

Encl: 1. Warning label 2. CTB VS-366A 3. Vansource Customer Emergency Training Course - Issue 1 4. Vansource Customer Emergency Training Course - Issue 2

. .> 4

1

W h)

Written Notification in accordance with IOCFR21.21 (d)(3)(ii) and 1 OCFR21.21 (d)(4)

1. Name and address of the individual or individuals informing the Commission.

Richard G. Piccolo Varian Medical Systems, Inc 700 Harris Street, Ste 109 Charlottesville VA 22902

2. ldentification of the facility, the activity, or the basic component supplied for such facility or such activity within the United States which fails to comply or contains a defect.

VariSource HDR Afterloader model 200 VariSource HDR Afterloader model ID

3. ldentification of the firm constructing the facility or supplying the basic component which fails to comply or contains a defect.

The VariSource HDR Afterloader is manufactured by:

Varian-TEM Ltd. Gatwick Road Crawley, West Sussex RH102RG United Kingdom

4. Nature of the defect or failure to comply and the safety hazard which is created or could be created by such defect or failure to comply.

Nature of the defect or failure

The active source can become dislodged from the internal tungsten safe a the emergency source retract hand crank is used when the active source is safely parked in the internal shield.

1. This event can only occur if the operator turns the emergency hand crank while the source is safely parked.

2. The emergency source retract hand crank is to be used only when the active source is in the "out" or "exposed" position. It is not designed, nor intended to be operated when the source is safely parked.

3. The emergency hand crank is only connected to the active source wire. It is not connected to the dummy source and its operation has no effect on the dummy source.

There have been 4 events where the active source wire has been pulled from the VariSource shield by improper use of the emergency hand crank.

lncan Hospital - Mexico City, Mexico - 2/27/04 University of Kentucky, Lexington - 4/4/06 New York Presbyterian, NYC - 4/20/07 City of Hope, Duarte - 7/15/07

Page 1 of 12

Varian investigated these events and it was determined that each was the result of operator error due to improper use of the emergency hand crank. In three events an untrained person initiated the event

lncan -initiated by a junior physicist with no record of training University of Kentucky - initiated by therapy students with no prior training City of Hope - initiated by a physicist that had not been trained on the unit

Safety hazard - unintended radiation exposure from the source being outside the tungsten shield.

In each event the radiation exposure has been very low. An analysis of all four events shows the following:

Total collective dose equivalent for 4 events - 468 mrem Average dose equivalent per event - 117 mrem Highest individual dose equivalent - 66 mrem Average individual dose equivalent - 28 mrem

Using in-house procedure, Varian performed a hazard analysis for a hypothetical worst case scenario. This time and motion study assumed a 12 Ci lr-192 source with a patient in the room attended by two clinicians. The estimate also includes the dose to Varian personnel during recovery of the source. The analysis estimates a collective dose of 313 mrem with the highest individual dose of 151 mrem being received by one Varian employee during source recovery.

The hazard analysis considers both the severity of the exposure and the probability of the event occurring. In this scenario:

Severity of the exposure is Negligible, meaning it is not likely to result in injury or illness, Probability is Remote, meaning that it is unlikely to occur, but is possible during the life of an individual item; and reasonably expected to occur in the installed base. Taken together the Risk of this event IS Acceptable within the context of the Varian hazard analysis procedure.

5. The date on which the information of such defect or failure to comply was obtained

July 15, 2007 - City of Hope Hospital in Duarte, California

6. In the case of a basic component which contains a defect or fails to comply, the number and location of all such components in use at, supplied for, or being supplied for one or more facilities or activities subject to the regulations in this part.

There are 191 VariSource HDR units in the United States. Locations where the units are used in the United States are given in the table below. There are more than 191 hospital and clinic sites listed below since in several instances physics services are contracted to several hospitals using a transportable HDR unit.

Page 2 of 12

Terrabonne General Medical Center Cape Cod Hospital Carilion Health Svstems - Roanoke

8120 Main St,. Houma LA 70360 27 Park Street Hyannis MA 02601

Page 3 of 12

__ Virginia Carolinas Medical Center Cedars Medical CenterICancer Healthcare Associates PA Central Mississippi Medical Center Centre Community Hospital/Mount Nittany Medical Center

2013 South Jefferson Street Roanoke VA 24014 1000 Blythe Blvd Charlotte NC 28203

1321 NW 14th Street Miami FL 33136 1850 Chadwick Drive Jackson MS 39204

1800 East Park Avenue State College PA 16803

Dubois

East Jefferson General Hospital Eastern Regional Medical Center Edward (Hospital) Center for

Durango Cancer Center 100 Hospital Avenue Dubois PA 15801

4200 Houma Blvd. Metairie LA 70006 1331 East Wyoming Ave Philadelphia PA 19124

co xxx

. . Radiation. Therapy Edwards Cancer Center Emory Clinic - Crawford Long Hospital Erlanger Hospital (Baroness Campus) Evanston Hospital - Northwestern

120 Spaulding Dr.,. Naperville IL 60566 1612 Hospital Parkway Bedford TX 76022 26 Pine Atlanta GA 30308 975 East Third Street Chattanooga TN 37403

Page 4 of 12

Healthcare Exempla Lutheran Hospital Geisinger Health System Good Samaritan-Los Gatos CA Good Shepherd Hospital - Barrington Illinois Great Falls Clinic Gundersen Lutheran Medical Center

2650 Ridge Avenue Evanston IL 60201 8200 W. 38th Avenue Wheat Ridge CO 80033 1000 East Mountain Drive Wilkes-Barre PA 18711 15400 National Averhe Los Gatos CA 95032

450 West Highway 52 Barrington IL 60010 3000 15th Ave South Great Falls MT 59404 1836 South Avenue La Crosse WI 54601 Judd Cancer Trmt Cntr,

Hamilton Medical Center - Dalton GA Harper Grace Hospital

Henrico Doctor's Hospital Hershey Medical Center

1200 Memorial Dr Dalton GA 30722 6071 West Outer Drive Detroit MI 48325 7603 Forest Avenue, Ste 106 Richmond VA 23229 500 University Drive Hershey PA 17033

Page 5 of 12

Mt. Sinai - Miami Beach Nebraska Medical Center

4300 Alton Rd Miami Beach FL 33140 4367 Emile Street Omaha NE 68198 3537 South Interstate-35

Network Cancer Care - Denton TX Network Cancer Care - Plano TX New Mexico Oncology (aka NM

East, Suite 120 Denton TX 76210 5948 W. Parker Road Plano TX 75093

Penrose - St.'Francis Health Services 1 2215 North Cascade Avenue I Springs Pocono Medical Center (The Dale and I I East I I

180907

(Gainesville) North Star Lodge Cancer Center Northeast Louisiana Cancer Institute -

1021 NW 64th Terrace Gainesville FL 32605 281 1 Tieton Drive Yakima WA 98902

Page 6 of 12

Glenwood Northeast Louisiana Cancer institute - Monroe

503 McMillan Road West Monroe LA 71291

41 1 Calypso Drive Monroe LA 71201 3060 Salt Creek Lane, Suite Arlington

Frances Hughes Cancer'Center) Pomona Valley Hospital Medical Center Porter Adventist Hospital - Centura Health Providence Hospital (Anchorage AK) Providence Hospital (Everett WA) Providence Medford Cancer Center (Medford)

231 E Brown Street Stroudsburg PA 18301

1910 Royalty Drive Pomona CA 91767

2525 S Downing Street Denver co 80210 3200 Providence Drive Anchorage AK 99519 1717 13'h Street Everett WA 98201

11 11 Crater Lake Ave Medford OR 97504

aseo de Valencia

Southwest Regional Cancer Center 1 901 W 38th Street

stin Cancer Center qmi Hosnitnl Inc

Austin TX 78705 ~ ~

g Branch Regional Cancer

Page 7 of 12

St. Jude's Hospital (Vantage Radiation Oncology) St. Luke's - Mountain States Tumor

* 101 E Valencia Mesa Drive Fullerton CA 92634

Institute - Idaho St. Luke's Hospital of Kansas City St. Mary Cowin Hospital St. Mary's Hospital - Evansville IN St. Mary's Regional Hospital (Reno)

St. Michaels Medical Center

Page 8 of 12

656 Addison Ave West Twin Falls ID 83301 4401 Wornall Road Kansas City MO 641 11 1008 Minnequa Avenue Pueblo co 81004 3801 Bellemeade Ave. Evansville IN 47714 235 W 6th St Reno NV 89520 268 Martin Luther King Jr Blvd Newark NJ 07105

New St. Peters University Hospital St. Vincent Cancer Center St. Vincent Hospital (Green Bay WI) St. Vincent's HosDital - Portland

254 Easton Avenue Brunswick NJ 08903 325 West 15th Street New York NY 10011 835 S Van Buren Green Bay WI 54301

-*

University of Minnesota Medical

7. The corrective action which has been, is being, or will be taken; the name of the individual or organization responsible for the action; and the length of time that has been or will be taken to comDlete the action.

Customer Technical Bulletin CTB-VS-366A, entitled "Clarification on the use of the emergency retract hand wheel to prevent accidental exposure" was issued to all users of the VariSource HDR unit on April 27, 2004. A copy of the CTB is enclosed The CTB will be reissued to all domestic customers by March 31, 2008.

Label- a warning label addressing the proper use of the emergency hand crank was attached to all VariSource HDR units during the 3d and 4'h quarter of 2004. A new warning label is being developed that will restate the proper use of the hand crank as well as the consequences of its improper use. The new label will be retrofitted to existing domestic units and applied to all new units during manufacturing. A copy of the current warning label is enclosed. The new warning label will be issued by March 31, 2008.

User training - a formal revision was made to user training to emphasize that this event is possible if the user makes an error by operating the emergency hand crank when the active source wire is safely parked in the tungsten shield.

Page 9 of 12

Varian User Training has always included instruction on the proper use of the emergency hand crank. Following the lncan event changes were made to the content of training that is provided to new users.

Section 4.3 of Issue 1, Varian Document AL25244000 “VariSource 200 Series Customer Emergency Training Course” contains an instruction item for use of the emergency hand crank and includes a check box to ensure the instruction is completed. This document was amended in Issue 2, effective 11/2004 to include two specific items related to how improper use can cause the active source to be pulled from the tungsten shield. In particular the new items read:

1. Active Source Wire Only (Not for Dummy Wire Manual Retract) 2. Maximum of 12 Turns or until Radiation Detector is silenced

Each instruction has a check box indidating “Confirmed to ensure that it is addressed. A copy of both Issue 1 and Issue 2 of this training item is enclosed

User training is being revised again to p r o h e more instruction on the proper use of the emergency hand crank and to further emphasize that the emergency hand crank is not attached to the dummy wire. Trainees will be required to sign or initial a specific acknowledgement that they have received and understand the training on the proper use of the emergency hand crank and the potential problems if the hand crank is improperly used. User training will be updated by March 31, 2008.

b

User manual - the User Manual was revised to provide additional instruction on the proper use of the emergency hand crank. CTB-VS-366A, “Clarification on the use of the emergency retract hand wheel to prevent accidental exposure” was issued on April 27, 2004. At that time Issue 3 (issued 04/01) of the VariSource User Manual had been in production and was being provided to all new users as part of the HDR system documentation. Issue 4 of the VariSource User Manual was approved November 2005 and contained this amended language about proper use of the hand crank.

Changes to the Instructions for the Emergencv Retract hand wheel -Chapter 6 The following section is added to the end of Table A on aape 6-4 of the Users Manual

I Caution: Do not continue to rum the hand wheel after the independent radiation monitor no longer detects radiation. In some circumstances, it is possible that excessive turning of the hand wheel on a parked wire can cause it to become dislodged from the shielding inside the Afterloader.

Do not use the manual retract hand wheel with the dummy wire. There is no connection between the manual retract hand wheel and the dummy wire.

I

The Manual is being revised again to provide additional warnings and instructions related to the proper use of the emergency hand crank and to further emphasize that the emergency hand crank is not attached to the dummy wire. The User Manual will

Page 10 of 12

be distributed to all new customers and to all existing domestic customers. The User Manual will be updated and distributed by March 31, 2008.

Engineering - Design Evaluation - The Engineering Department is in the early stages of investigating a design solution that may mitigate the ability of the wire to pull from the safe. Due to the criticality of the emergency hand crank functionality we do not anticipate having an answer to the plausibility of this solution until the first quarter of 2008.

ResDonsible orcranizafion - Varian Brachytherapy is the responsible organization within Varian Medical Systems, Inc.

Lenoth of time that will be taken to comiolete the action - Corrective action will be completed by March 31, 2008.

8. Any advice related to the defect or failure to comply about the facility, activity, or basic component that has been, is being, or will be given to purchasers or licensees.

Response is that same as in #7 above with the exception of the Engineering evaluation of a design solution.

Customer Technical Bulletin CTB-VS-366AS entitled "Clarification on the use of the emergency retract hand wheel to prevent accidental exposure" was issued to all users of the VariSource HDR unit on April 27, 2004. A copy of the CTB is enclosed. The CTB will be reissued to all domestic customers by March 31, 2008.

Label- a warning label addressing the proper use of the emergency hand crank was attached to all VariSource HDR units during the 3d and 4'h quarter of 2004. A new warning label is being developed that will restate the proper use of the hand crank as well as the consequences of its improper use. The new label will be retrofitted to existing domestic units and applied to all new units during manufacturing. A copy of the current warning label is enclosed. The new warning label will be issued by March 31, 2008.

User training - a formal revision was made to user training to emphasize that this event is possible if the user makes an error by operating the emergency hand crank when the active source wire is safely parked in the tungsten shield.

Varian User Training has always included instruction on the proper use of the emergency hand crank. Following the lncan event changes were made to the content of training that is provided to new users.

Section 4.3 of Issue 1, Varian Document AL25244000 "VariSource 200 Series Customer Emergency Training Course" contains an instruction item for use of the emergency hand crank and includes a check box to ensure the instruction is completed. This document was amended in Issue 2, effective 11/2004 to include two specific items related to how improper use can cause the active source to be pulled from the tungsten shield. In particular the new items read:

Page 11 of 12

1. Active Source Wire Only (Not for Dummy Wire Manual Retract) 2. Maximum of 12 Turns or until Radiation Detector is silenced

Each instruction has a check box indicating "Confirmed" to ensure that it is addressed. A copy of both Issue 1 and Issue 2 of this training item is enclosed

User training is being revised again to provide more instruction on the proper use of the emergency hand crank and to further emphasize that the emergency hand crank is not attached to the dummy wire. Trainees will be required to sign or initial a specific acknowledgement that they have received and understand the training on the proper use of the emergency hand crank and the potential problems if the hand crank is improperly used. User training will be updated by March 31, 2008.

Usermanual - the User Manual was revised to provide additional instruction on the proper use of the emergency hand crank. CTB-VS-366A, "Clarification on the use of the emergency retract hand wheel to prevent accidental exposure" was issued on April 27, 2004. At that time Issue 3 (issued 04/01) of the VariSource User Manual had been in production and was being provided to all new users as part of the HDR system documentation. Issue 4 of the VariSource User Manual was approved November 2005 and contained this amended language about proper use of the hand crank.

Changes to the Instructions for the Emergency Retract hand wheel -Chapter 6

The followinp section is added to the end of Tuble A on pape 6-4 of the Users Manual

Caution: Do not continue to ium the hand wheel after the independent radiation monitor no longer detects radiation. In some circumstances, it is possible that excessive turning of the hand wheel on a parked wire can cause it to become dislodged from the shielding inside the Afterloader.

Do not use the manual retract hand wheel with the dummy wire. There is no connection between the manual retract hand wheel and the dummy wire.

The Manual is being revised again to provide additional warnings and instructions related to the proper use of the emergency hand crank and to further emphasize that the emergency hand crank is not attached to the dummy wire. The User Manual will be distributed to all new customers and to all existing domestic customers. The User Manual will be updated and distributed by March 31, 2008.

Page 12 of 12

DO NOT SCALE, IF IN DOUBT ASK

NOTES: 1. MATERIAL: SELF ADHESIVE MR PVC 0.009 THK

2. 3. TYPEFACE: HELMTICA MEDIUM

4. PRINTED CHARACTER SIZES MAY BE SCALED FROM A FULL

SUB-SURFACE PRINT

PRINT BLACK ON YELLOW (PANTONE 108C\

POSITION, SlZE AND WEIGHT TO BE CLOSE TO THOSE SHOWN

SlZE A3 PRINT W THIS DRAWING.

lmm SELF ADHESIVE DOUBLE SIDED FOAM BACKING

5. 6. FINAL ARTWORK SUBJECT TO APPROVAL BY VBT UK ENGINEER 7. 3AG si TAG h: iDEFiTliY %lid DRAWING NiJMaER AND

GENERAL WARNING SYMBOL - PRINT BLACK ON YELLOW (PANTONE 108C) BACKGROUND

APPROPRIATE ISSUE NUMBER.

100 1

Active Source Wire Emergency 1 Retractonly.Turnthehand 1 1 wheel for a maximum of 12

turns, or until the radiation alarm ceeses. Contact Varian Service

axm?tau (ENWSI)

April 27,2004

r d +I 434 977 8495 I fu+l 4342447181 i wx.v i r im.com

Medical Device Correction

Dear varisource user

The VariSource High Dosc Rate AMoadcr is subject to a labeling correction to clarify the propa USLI of ths Emagency Retract Hand wheel. This labeling OMTection applies to V a r i s W a model 200, ZOOt, and ID series.

&cessive nnning of the hwgeacy Rctrsct Hand wb&l when theaaive wire is parked can uulsc thc activo wire to becans dislodged fmm the shielding. The Emergency Rctnrt Hand Who21 is to be used to retract the active wire only and docs not control the dummy wire. Please set the attached Customer Technical Bulletin clarifying the Inmuctions For Us.

Please advise the appropriate personal working in your radiotherapy dqmrtment of the content of this letter and attached instructions.

We sincerely apologize for any inconvenience and thank you in advanc~ for your w-opcratbn. if you require further clarification, pleas feel free to cwtact your local Vruian Customtr Suppmi Representative.

&k H. Kamann Manager, Regulatory Affairs & Quality Systems

En: CTB-VS-366A

PNL-VS-36bA

I -1

m e d i c a l s y s t e m s I Customer

Technical Bulletin I I J

, I

RsfeMnCa Documents Series 200 mgh Dose Rate Remote Afterloader System User

Ma.nual. PIN: TM59781000 Series ID High Dose Rate Remote Afterloader System User Manual.

1. TmLE

Clarification on the use of the Emergency Retract Hand wheel to prevent accidental expoawe.

2. W NOT TURN THE EMERGENCY RETRACT HANDWHEEL WHEN THE ACTIVE WRE IS PARKED

~ ~ - R a s e refer to chapter 6 of the Series 200 High Dose Rate Remote Afterloader system User Manual. P f N: TM5978 1000 or chapter 2 of the Series ID High Dose Rate Remote Afterloader System User Manual. P/N: TM59651000 as applicable, for a discussion of the use of the emergency retract handwheel. In addition, please be aware of the following warning:

A Excessive turning of the emergency retract handwheel, after the active wire is parked, can cause it to move outside of the internal shielding. If use of the handwheel i s necessary, stop turning it as s m n the independent radiation monitor has stopped detecting radiation. It is predicted that the number of revolutions of the handwheel necessary to cause the Wire to move from the shielded position is in excess of 20.

3. THE DUMMY WIRE IS NOT CONNECTED TO THE EMERGENCY RETRACT HANDWHEEL

The handwheel is not used for retracting the dummy wire. If the dwnmy wire becomes stuck outside the afterloader, you must manually clear the obstruction to return the dummy wire to its to parked position by creating a system reset (remove and reapply power to the Afterloader.)

4130104. cm-Vs.36Bll.d~~

Varian BrachyTherapy 700 Harris Street Suite 109 Charlottesville, VA 22903

RECIEPT VERIFICATION CARD

Customer receipt verincation:

FiU out the Receipt Verification Card and FAX or e-mail immediately To Varian BrachyTherapy:

8GG-385-1322, ~ ( 9 4 9 ) 221-7631

CTB Number: CTB-V5-366A, Clarification on the use of the Emergency Retract Handle wheel to prevent accidental exposure.

Rodact Code:

Name of Institution:

Date of Receipt:

Customer Name:

Comments

Serial Number:

Varian BrachyTherapy Technical Support Contacts

~

1782221 1 Swiwlaad 1 080 0800 25 61 1 Taiwan 1 0080

I I I I I I 18882953199 I h addition, toll free access using the AT&T International direct dialing network is available in over 150 countries. TO access this number, dial first the AT&T access number in p u r area (for the access code in your area, see internet address: hm;! /www.att.com/business~ travelerlmides and accesslinternational dialine.html). Then aftm hearing the AT&T signatwe noise, and, 'Please enter the number you are calling., dial: 800360-7909

For countries not listed above or not in the AT&T International dialing network, Telephone Support may be obtained via the foIlowing numbers:

UK: +44 1293-601-327 USA: + 1-434-979-1540

Our Applications Specialists can immediately return any calls received on these numbers.

k h p p o r t Please fax your questions to Brachflkerapy Techrucal Support on:

UK: +44 1293-542-626 USA: +1-866-385.1322

+ 1-949-221-7631 . e-ldrll To submit a support request or general inquiry, please compose an ernail with a blank subject line, to: bsachvhel?Shwian.cm . Please indicate the name of your institution, your name and phone number, the product you are commenting on, and your system number (Xlcnowm), as well as the d d p t i o n of the problem or question. - Note that Customer Technical Bulletins for Varian Medical Systems may be found on the internet at: httD:/ /www.varian.comlonc/ind~.html, under 'Support'. They are organized by year of issue and title.

4130104, CJSVS-3664 6+X -. - Varian Medical Systems - BrachyThexapy Offices

109-700 Harris Street Gatwick Road BeMsche Strasse 16 Charlottesville, VA 22903 Crawley, Sussex, RH10-9RG 4278 1, Haan Tel: 434-977-8495 Tel: 44-1293-6012 19 Tcl: 49-2129551-0

Varinn Medical Systems - OncoloE~ Spotems Field Service Offices

USA United Kingdom 0e-y

unttexi states Centers

HeadqueJtors 5% Alder Drive Milpitas, CA 95035 Tel 408-32 1-9400

Northeast 100 Wahut Avenue Suite 201 Clark, %.J 07066 Tel: 732-381-5300

southeast 2250 Newmarket Parkway suite 120 Marietta, GA 30067 Tel: 770-955-1775

Midwest 200 East Howard Street suite 202 Des Plaines, 1L 600 1 8 Tel: 847-296-0660

&uthwest 403 International Pkwy Suite 503 Richardson, TX 7508 1 Tel: 972-238-7017

We& 650 East Parkndge Avenue Suite 109 Corona, CA 92879-1092 Tel: 1-909-280-4406

_. - rnternational Centers

Australla Unit 6, 81 Frenchs Forest Road (East) Frenchs Forest New South Wales 2086 Tel: 6 1-219975-8830

BrEZil Rua Vidoum, 63-Conj. 131 Itaim Bibi 04538-1 10 Sao Paulo TeI: 55-1 118294705

Denmark Lyskaer 9 DK-2730 Herfev Tel: 45-441500-100

France C.A. A. Tolbiac-kl a e n a 5, rue Watt 75644-ParisCrdex13 Tel: 33-1-53.60.X2.11

GsrBl.3Dy

D-64289 D-stadt Alsfelder Strassc 6

Tel: 494151 17313.0

I d i 8 Ground Floor, Muniapd MKT behind Dinanath Mangeshkar Hall Tejpal Road, Vile Parle (E)

I W Y

Italy

Via Brcscia 28D1 20063 Cernusco SIN (MI)

Tel 39-02-92 1.35 1

uong Xong Room 1018-20, Tower A Mandarin Plaza 14 Science Museum Road Tsimshatsui East, Kowloon Tel: 852/2724-2836

Netherlands Nederland B.V Kokermolen 2 3994 DH Houten Netherlands

P.R china 76 Zhichun Road Haidian District Beijing PRC IO0086 Tel: 86- 10/ 65 12-3667

Spain Via dos CastiUas, 33 Compl. Atica. Edif. 7 Bajo 28224 Pozuelo de Atarcon Madrid, Spain 34 91 799-4530

Switzerland Chollerstrasse 38 Postfach3363 CH-6303 Zug Tel: 41-41 1749-8844

United Kingdom Gatwick Road Cmwley, Sussex RHlO 2RG-U.K. Tel: 44-1293/53 12 44

Varian Brachytherapy

AL25244000 - VariSource 200 Series Customer Emergency V A R ~ A N m.dls.1 .r.t.mm

Training Course

Independent Treatment Room Radiation Monitor Yes 0

Slave Radiation Monitor in Console Area Yes 13

Beam on lamps Yes 0

Calibrated Survey Meter Yes 0

Patient Video Monitoring Yes

Patient Audio Monitoring Yes 0

Emergency Lighting in Treatment Room Yes 0

Emergency Lighting in console Area Yes 13

VariSource Emergency Procedures on Display Yes 0

VariSource 24hr. Emergency Dispatch or Regional Service Office Phone Number Displayed Yes 0

1 Introduction

The following information is to be presented to the site Radiation Safety Officer (RSO), authorized user and the medical physicist and provides an overview of the VariSource safety features and emergency responses. This training does not represent clinical or applications training.

US ONLY:

During all patient treatments, the authorized user and either a medical physicist or the site Radiation Safety Officer must be physically present (see US. NRC Bulletin 93-01, April 20,1993).

No 0

No 0

No 0

No 13

NO

No 0

No 0

No 0

No 0

No

The site Radiation Safety Officer shall be responsible for the formal radiation safety training as required by site policy and local regulatory requirements.

For the VariSource 200t model, this course shall be conducted with relevant personnel at all operational sites.

Page 1 of 4 AL25244000 Issue 1 EGO9606

Varian Brachytherapy

AL25244000 - VariSource 200 Series Customer Emergency V A R ~ A N medIc.1 .y.t.rn.

Training Course

3 VariSource Safety Features

Confirm that the location of the following features and the correct operation where required

Three position key switch on Console (Lock, On, Treat) Confirmed

Two position key switch on Afterloader (Lock, Treat) Confirmed

STOP switch on Aflerloader, Wall Box and Console Box Confirmed

Treatment Room Door Interlock Switch Confirmed

Last Man Out Switch Confirmed

UPS for Afterloader and Console Confirmed

Afterloader self-contained Emergency Retract Batteries Confirmed

User mode Passwords (System access and Physics mode) Confirmed

Unique 5 digit Password to deliver patient treatment Confirmed

Aflerloader Radiation Detector (with battery back-up) Confirmed

Afterloader Active Wire Lock and status indicator (200t only) Confirmed

Closed-end catheters and applicators Confirmed

Importance Of Containment Issues Discussed Confirmed

4 Retract Operations I Conditions

There are three separate levels of Active wire retract condition on the VariSource 200 Series Afterloader.

4.1 Main (Normal) Retract A Stepper Motor retract occurs due to treatment completion, treatment interruption, or as a result of a non-emergency error.

Confirmed

4.2 D.C. Motor Emergency Retract Engagement of the Emergency Retract Motor is initiated by a self-detected emergency condition or as a result of Main (Normal) Retract failure, such as failing to park the Active Source wire.

Confirmed 0

The Emergency Retract Motor will operate until the Active wire reaches the parked position or until the Afterloader Retract Battery is drained. Site personnel are advised that the source may continue moving back into the Aflerloader anytime that the hand wheel is turning.

AL25244000 EC09606

Page 2 of 4 Issue 1

I .

Varian Brachytherapy I VARiANI med15.1 .ysram.

AL25244000 - VafiSource 200 Series Customer Emergency Training Course

4.3 Manual Retract Handwheel The manually operated Emergency Retract Handwheel is provided in the event that the Afterloader fails to retract the Active wire to the parked position

Confirmed 0

5 Emergency Procedures

It is essential that the user familiarize themselves with and regularly rehearse the procedures outlined below.

Refer to the document 'Emergency & Safety Instructions For SL77N & VS2000 Source Wires Used In VariSource HDR Afterloaders' (shipped with all source wires) for relevant Emergency Procedures

Confirmed L3

With an Inactive wire installed, VariSource personnel will disconnect the Emergency Retract Batteries extend the Inactive wire to 150.0cm under Diagnostic Mode, and remove A/C power leaving the Inactive wire extended.

Each site-designated person will perform a manual retract of the wire by turning the Emergency Handwheel until the wire is in the safe and parked position.

Confirmed

6 Emergency Procedures

Varian Oncology Systems must be immediately notified by phone and provide a written account of the occurrence as soon as possible when any activity related emergency is encountered during the use VariSource equipment.

US. contact:

24 Hours VariSource Dispatch (800) 864-1672

VariSource Service Manager Varian Oncology Systems 596 Alder Drive Milpitas, California 95035

Fax: 408-321-4430 Ph: 408-321-4494

International sites contact:

The Regional Service Ofice as applicable

Confirmed

Confirmed 0

AL25244000 Issue 1 Page 3 of 4 EC09606

Varian Brachytherapy

AL25244000 - VariSource 200 Series Customer Emergency Training Course

7 Acknowledgment of course demonstration To be copied to each member of site personnel attending training course.

Institution Name

Address

VariSource Afterloader Serial Number

Date on which training completed

VariSource Representative

Print

Sign

Customer Representative(s)

Print

Print

Print

Print

Print

Print

Print

Print

Print

Sign Position

Sign Position

Sign Position

Sign Position

Sign Position

Sign Position

Sign Position

Sign Position

Sign Position

AL25244000 EC09606

Issue 1 Page 4 of 4

Varian Brachytherapy

AL.25244000 - VariSource 200 Series Customer Emergency VA R ~ A N medical mv.1.m.

Slave Radiation Monitor in Console Area Yes 0

Beam on lamps Yes

Calibrated Survey Meter Yes 0

I I Training Course I

No 0

No 0

No 0

1 Introduction

Yes 0

Yes 5

The following information is to be presented to the site Radiation Safety Officer (RSO), authorized user and the medical physicist and provides an overview of the VariSource safety features and emergency responses. This training does not represent clinical or applications training.

No Q

No 5

us ora Y:

During all patient treatments, the authorized user and either a medical

Emergency Lighting in Treatment Room Yes tl

Emergency Lighting in Console Area Yes 0

VariSource Emergency Procedures on Display Yes 0

- . physicist or the site Radiation Safety Officer must be physically present (see U.S. NRC Bulletin 93-01, April 20, 1993).

No 0

No 0

No 0

The site Radiation Safety Officer shall be responsible for the formal radiation safety training as required by site policy and local regulatory requirements.

For the VariSource 20Ot model, this course shall be conducted with relevant personnel at all operational sites.

2

It is the responsibility of the site to ensure regulatory compliance through the provision of, maintenance and adequate testing of safety equipment and facilities.

Regulatory Compliance I Site Specific Issues

Feature

Independent Treatment Room Radiation Monitor

Available

Yes 1 No tl

Patient Video Monitoring

Patient Audio Monitoring

VariSource 24hr. Emergency Dispatch or Regional Service Office Phone Number Displayed Yes 0 No Q

AL25244000 EC12004

Issue 2 Page 1 of 6

Varian Brachytherapy

AL25244000 - VariSource 200 Series Customer Emergency V A R ~ A N m.dlc.l ny.1.m.

Training Course

3 VariSource Safety Features

Confirm that the location of the following features and the correct operation where required

Three position key switch on Console (Lock, On, Treat)

Two position key switch on Afterloader (Lock, Treat)

STOP switch on Afterloader. Wall Box and Console Box

Emergency Stop Switch

Treatment Room Door Interlock Switch

Last Man Out Switch

UPS for Afterloader and Console

Afterloader self-contained Emergency Retract Batteries

User mode Passwords (System access and Physics mode)

Unique 5 digit Password to deliver patient treatment

Afterloader Radiation Detector (with battery backup)

Afterloader Active Wire Lock and status indicator (200t only)

Closed-end catheters and applicators

Importance Of Containment Issues Discussed

Confirmed

Confirmed

Confirmed

Confirmed

Confirmed

Confirmed

Confirmed

Confirmed

Confirmed

Confirmed

Confirmed

Confirmed

Confirmed

Confirmed

0

0

0

0

l3

0

0

0

4 Retract Operations I Conditions

There are three separate levels of Active Wire retract condition on the VanSoorce 200 Series Afterloader

4.1 Main (Normal) Retract A Stepper Motor retract occurs due to treatment completton, treatment mterruptlon, or as a result of a non-emergency error Confirmed 0

4.2 D.C. Motor Emergency Retract Engagement of the Emergency Retract Motor is initiated by a self-detected emergency condition or as a result of Main (Normal) Retract failure, such as failing to park the Active Source wire

Confirmed 0

The Emergency Retract Motor will operate until the Active wire reaches the parked position or until the Afterloader Retract Battery is drained. Site

AL25244000 EC12004

Issue 2 Page 2 of 6

I V A R i A N Varian Brachytherapy

AL25244000 - VariSource 200 Series Customer Emergency Training Course

personnel are advised that the source may continue moving back into the Afterloader anytime that the hand wheel is turning.

4.3 Active Source Wire Manual Retract Handwheel The manually operated Active Source Wire Emergency Retract Handwheel is provided in the event that the Afterloader fails to retract the Active wire to the parked position:

Active Source Wire Only (Not for Dummy Wire Manual Retract)

Maximum of 12 Turns or until Radiation Detector I S silenced

Confirmed

Confirmed 0

5 Emergency Procedures

It is essential that the user familiarize themselves with and regularly rehearse the procedures outlined below.

Refer to the VariSource 200 Series User Manual and relevant User Manual Amendment sheets for relevant Emergency Procedures.

Confirmed 0

With an Inactive wire installed, VariSource personnel will disconnect the Emergency Retract Batteries extend the Inactive wire to 150.0cm under Diagnostic Mode, and remove N C power, leaving the Inactive wire extended.

Each site-designated person will perform a manual retract of the wire by turning the Emergency Handwheel until the wire is in the safe and parked position.

Confirmed 0

6 Emergency Procedures

Varian Oncology Systems must be immediately notified by phone and provide a written account of the occurrence as soon as possible when any activity related emergency is encountered during the use VariSource equipment.

U.S. Contact:

24 Hours VariSource Dispatch (800) 864-1672

VBT North America Customer Support Manager Charlottesville. VA Ph: 434-977-8495, Extension 239

VBT Radiation Safety Officer Varian Brachytherapy Charlottesville, VA Ph: 434-977-8495, Extension 275 Confirmed 0

AL25244000 EC12004

Issue 2 Page 3 of 6

Varian Brachytherapy

AL25244000 - VariSource 200 Series Customer Emergency Training Course

International Sites Contact:

The Regional Service Office as applicable. Confirmed 0

AL25244000 Issue 2 Page 4 of 6 EC12004

Varian Brachytherapy

AL25244000 - VariSource 200 Series Customer Emergency Training Course

7 Acknowledgment of course demonstration To be copied to each member of site personnel attending training course.

Institution Name

Address

VariSource Afterloader Serial Number

Date on which training completed

VariSource Representative

Print

Sign

Customer Representative(s)

Print

Print

Print

Print

Print

Print

Sign

Sign

Position

Position

Sign Position

Sign

Sign

Position

Position

Position

Print

Print

Print

Sign

Sign

Sign

Position

Position

Position

AD5244000 Issue 2 Page 5 of 6 EC12004

Varian Brachytherapy

AL25244000 - VariSource 200 Series Customer Emergency Training Course

Am endm en t Record

Issue

E Incorp. by

C Leak

C Leak

Date 0412002 1112004

- __

~ ~~~~

Pages affected New Document, was previously TM59493000 3 Emergency Stop Switch test added 4 3 Manual Retract - clarification of usage 5 Removed reference to AL25240000 - Emergency and Safety Instructions For VS2000 Source Wires Used In VariSource HDR Afterloaders 6 Uodated contact details

EGO No. EC9606

EC12004

AL25244000 Issue 2 Page 6 of 6 EC12004