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BRACHYTHERAPY SOLUTIONS FOR TREATING SKIN CANCER APPLICATORS & ACCESSORIES

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Page 1: BRACHYTHERAPY SOLUTIONS FOR TREATING SKIN … · Page 8 TO ORDER: applicators@varian.com C 0086 GM11004370 Catheter Flap Set – CT Compatible / MR Compatibility: Conditional Qty.*

BRACHYTHERAPY SOLUTIONS

FOR TREATING SKIN CANCER

APPLICATORS & ACCESSORIES

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BrachyTherapy Applicators & Accessories Page 3 © 2013 Varian Medical Systems, Inc.

Intraoperative and Surface Applicators and Accessories

GM11004440 Mould Applicator Set – CT Compatible / MR Compatibility: Conditional 5

GM11004370 Catheter Flap Set – CT Compatible / MR Compatibility: Conditional 7

GM11010080 Surface Applicator Set with Leipzig-style Cone 9

GM11004590 Surface Applicator Set 11

Third-party H.A.M. Applicators 13

Accessories Standard Imaging Fixture and Ion Chamber for Commissioning 14

Some products might not be available in certain countries. Please contact your local representative for specifi c product registration status in your country.

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BrachyTherapy Applicators & Accessories Page 5 © 2013 Varian Medical Systems, Inc.

Afterloader: GammaMedplus iX™ / GammaMedplus™ Modality: HDR, PDR

Mould Applicator Set CT Compatible / MR Compatibility: ConditionalIntended for: HDR or PDR intraoperative and superficial brachytherapy

GM11004440

The Mould Applicator Set is used for the treatment of individual extremities, for bone tumors, and for surgical implanting (24-hour maximum implant time) as part of the IORT treatment. The 320 mm length and ample flexibility combine to provide optimal adaptation to a patient’s anatomy.

• Suitable for intraoperative and superficial brachytherapy • CT Compatible • MR Compatibility: Conditional for 1.5 and 3 Tesla, if used without channel markers and mandrins • Mould probes of 2.8 mm diameter (reusable) and 1.84 mm diameter (disposable) • Equipped with stabilizing obturators for easy insertion • Elastomer material construction provides increased flexibility for easy placement as well as luminal rigidity which prevents kinks • Steam sterilizable

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Page 6 www.varian.com/brachytherapyTO ORDER: [email protected]

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GM11004440 Mould Applicator Set – CT Compatible / MR Compatibility: Conditional

Qty.* Product # Components of the Applicator Set

5 GM11002290 Mould probe, 1.84 diameter x 320 mm with mandrin

5 GM11002280 Mould probe, 2.8 mm diameter x 320 mm

1 GM11003810 Leak stop buttons, non-sterile, pack of 50

4 GM11009960 Sterilization plugs, cream (pack of 25)

Required Accessories

1 GM11008210 Basic Accessory Kit, GammaMedplus

Optional Components and Accessories

1 GM11003100 Mandrin, 320 mm

1 GM11003740 Red buttons, 9.5 mm diameter, non-sterile, pack of 50

1 GM11003850 Green buttons, 9.5 mm diameter, non-sterile, pack of 50

1 GM11003760 Blue buttons, 9.5 mm diameter, non-sterile, pack of 50

1 GM11003690 Yellow buttons, 9.5 mm diameter, non-sterile, pack of 50

1 GM11003780 Violet buttons, 9.5 mm diameter, non-sterile, pack of 50

1 GM11003790 White buttons, 9.5 mm diameter, non-sterile, pack of 50

1 GM11003800 Universal fi xation buttons, radiopaque, non-sterile, pack of 100

1 GM11003770 Channel marker clips coded 13-24

1 GM11009620 X-ray marker BV set I, up to 320 mm applicators, coded 1-6

1 GM11009630 X-ray marker BV set II, up to 320 mm applicators, coded 7-12

1 GM11001390 Source guide tube support, GammaMed units only

*Quantity indicated is the quantity included with the kit. Quantity associated with each part number is one (1) unless otherwise indicated in the product description.

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BrachyTherapy Applicators & Accessories Page 7 © 2013 Varian Medical Systems, Inc.

The Catheter Flap Set is used for treatment of superficial cancers. It is designed to create a defined space between the source and the tissue, and between the source channels. The highly flexible material easily adapts to complex anatomical regions. The delivery size of the flap is 200 x 290 x 10 mm and can be reduced as needed. The catheter channels are 2 mm in diameter and are positioned on the middle axis of the flap.

• Suitable for skin/surface applications • CT Compatible • MR Compatibility: Conditional 1.5 and 3 Tesla, when all metal parts are removed • Flap is engineered to provide a consistent and defined space between the source and the tissue • Flexible material easily adapts to uneven surfaces • Large size of 200 x 290 x 10 mm can be cut to the required size • Steam sterilizable

Afterloader: GammaMedplus iX™ / GammaMedplus™ Modality: HDR, PDR

Catheter Flap Set CT Compatible / MR Compatibility: ConditionalIntended for: HDR or PDR superficial brachytherapy

GM11004370

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Page 8 www.varian.com/brachytherapyTO ORDER: [email protected]

C0086

GM11004370 Catheter Flap Set – CT Compatible / MR Compatibility: Conditional

Qty.* Product # Components of the Applicator Set

1 GM11003910 Catheter fl ap, 200 x 290 x 10 mm, 40 channels

10 GM11002290 Mould probe, 1.84 mm diameter, 320 mm length with mandrin

1 GM11003940 Channel marker clips, coded 1-12

1 GM11003800 White fi xation buttons, radiopaque, non-sterile, pack of 100

1 GM11003810 Leak stop buttons, non-sterile, pack of 50

4 GM11009960 Sterilization plugs, cream (pack of 25)

Required Accessories

1 GM11008210 Basic accessory kit, GammaMedplus

1 GM11008310 Accessory kit for Catheter Flap Set & Heyman Packing Applicator

Optional Components and Accessories

1 GM11000530 Bronchial catheters, 5Fr., sterile, GammaMedplus

1 GM11000470 Clamping adapters for 5Fr. bronchial catheter, GammaMedplus

1 GM11002260 Bronchial catheters, 1.84 mm diameter, sterile

1 GM11006270 Monofi l, 0.8 mm diameter, sterile, for bronchial catheters

1 GM11001640 Length cutting gauge for bronchial catheters, 1.84 mm

1 GM11001390 Source guide tube support, GammaMed units only

1 GM11000550 Clamping adapter for bronchial catheter 1.84 mm, GammaMedplus

1 GM11000160 Length cutting gauge for 5Fr. bronchial catheter

1 GM11009660 X-ray marker BV set Intraluminal, up to 1300 mm length, coded 1-3

*Quantity indicated is the quantity included with the kit. Quantity associated with each part number is one (1) unless otherwise indicated in the product description.

Flaps are available for intraoperative techniques:In the USA, please refer to http://www.micknuclear.com/page_iort/iort.aspIn Europe, please refer to http://www.kabe-labortechnik.de/index.php?sprache=en&akt_seite=startseite_produkte.php

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BrachyTherapy Applicators & Accessories Page 9 © 2013 Varian Medical Systems, Inc.

The Surface Applicator Set with Leipzig-style Cone is used as a cost effective replacement for superficial X-ray therapy. The optimal scattering of the tungsten alloy shielding creates a homogenous dose pattern in the area of treatment to the correct depth. A typical application for this surface applicator is the treatment of small skin cancer.

• Suitable for skin/surface and tissue applications • Optimal scattering of tungsten shield creates a homogenous dose at the skin’s surface to the correct depth • Equipped with multiple insets which allow for optimal dose adaptation to the target area • Requires disinfection only • Modeled in the BrachyVision’s solid applicator library for calculation with Acuros BV

Not authorized for use in Canada

Afterloader: VariSource iX™ / VariSource 200™ / GammaMedplus iX™ / GammaMedplus™ Modality: HDR

Surface Applicator Set with Leipzig-style ConeIntended for: HDR superficial brachytherapy

GM11010080

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Page 10 www.varian.com/brachytherapyTO ORDER: [email protected]

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GM11010080Surface Applicator Set with Leipzig-style Cone

Qty.* Product # Components of the Applicator Set

1 GM11010170 Leipzig-style Cone for inset 30-45 mm diameter, with holder and guide

1 GM11003520 Surface cone inset 30 mm diameter, round

1 GM11003610 Surface cone inset 35 mm diameter, round

1 GM11003620 Surface cone inset 40 mm diameter, round

1 GM11003630 Surface cone inset 45 mm diameter, round

4 GM11009960 Sterilization plugs, cream (pack of 25)

Required Accessories VariSource iX and 200

1 GM19001010 ClickFit™ applicator transfer guide tube, channel 1 VariSource 200

1 AL13169000 Measurement ruler

1 AL13154000 Measurement marker wire

1 AL13119000 Measurement marker clip

Required Accessories GammaMedplus Series

1 GM11000520 Source guide tube with locking mechanism for 113 mm needles, GammaMedplus

1 GM11000330 Length gauge, GammaMedplus

Optional Components and Accessories

1 GM11008700 Universal applicator clamping device

1 GM11001390 Source guide tube support (GammaMed units only)

1 GM11003810 Leak stop button (pack of 50), non-sterile

*Quantity indicated is the quantity included with the kit. Quantity associated with each part number is one (1) unless otherwiseindicated in the product description.

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BrachyTherapy Applicators & Accessories Page 11 © 2013 Varian Medical Systems, Inc.

The Surface Applicator Set has been developed as a cost effective replacement for superficial X-ray therapy, and uses the high dose rate source of the GammaMed unit. The optimal scattering of the tungsten alloy shielding creates a homogenous dose pattern in the treatment area. Treatment of a small skin cancer is an example of a typical application for this product.

• Suitable for skin/surface and tissue applications • Optimal scattering of tungsten shield creates a homogenous dose at the skin’s surface • Equipped with a variety of insets which allow for optimal dose adaptation to the target area • Requires disinfection only • Modeled in the BrachyVision’s Solid Applicator Library for calculation with Acuros

Afterloader: GammaMedplus iX™ / GammaMedplus™ Modality: HDR

Surface Applicator SetIntended for: HDR superficial brachytherapy

GM11004590

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Page 12 www.varian.com/brachytherapyTO ORDER: [email protected]

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GM11004590 Surface Applicator Set

Qty.* Product # Components of the Applicator Set

1 GM11003660 Surface Cone inset set, 10-25 mm diameter, round

1 GM11003670 Surface Cone inset set, 30-45 mm diameter, round

1 GM11003430 Surface Cone inset set, 30-45 mm diameter, oval

1 GM11003410 Shielding for Cone, 10-25 mm diameter, with fi xation

1 GM11003580 Shielding for Cone, 30-45 mm diameter, with fi xation

Required Accessories GammaMedplus Series

1 GM11000520 Source guide tube with locking mechanism for 113 mm needles, GammaMedplus

1 GM11000330 Length gauge, GammaMedplus

Optional Components and Accessories

1 GM11001390 Source guide tube support, GammaMed units only

1 GM11008700 Universal clamping device

2 GM11009960 Sterilization plus, cream (pack of 25)

*Quantity indicated is the quantity included with the kit. Quantity associated with each part number is one (1) unless otherwiseindicated in the product description.

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BrachyTherapy Applicators & Accessories Page 13 © 2013 Varian Medical Systems, Inc.

H.A.M. Flexible ApplicatorsBecause of its flexibility, the Harrison-Anderson-Mick (H.A.M.) Applicator easily conforms to the shape of surfaces to which it is applied. H.A.M. Applicators are provided with or without embedded catheters. An array of catheters are embedded parallel to each other spaced 10 mm apart while a consistent source-to-tissue distance of 5 mm is maintained. Embedded catheters are 130 cm long and connect directly to the remote afterloader’s indexer.

• Manufactured from Silicone Rubber (LSR) • Non-Toxic • 8 mm thick • Single use only • Delivery time per the manufacturer

For more information, visit www.micknuclear.com.

Afterloader: GammaMedplus iX™ / GammaMedplus™ Modality: HDR

Third-Party Applicators

H.A.M. ApplicatorsIntended for: HDR superficial or IORT brachytherapy

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Afterloader: VariSource iX™ / VariSource 200™ / VariSource ID™ / GammaMedplus iX™ / GammaMedplus™ Modality: HDR, PDR

Third-party Accessories

Standard Imaging Fixture and Ion ChamberIntended for: Output measurements of Varian surface applicators

BrachyTherapy Applicators & Accessories Page 14 © 2013 Varian Medical Systems, Inc.

To aid in the commissioning of the surface applicators, Standard Imaging manufactures a Surface Applicator In-Air Calibration Fixture for Varian applicators which holds a small ion chamber (Exradin A20, 0.074 cc) at a fixed distance to the surface applicator in air. With this setup, output measurements are easy to obtain and can be used to verify the output data supplied with the surface applicator sets.

• End-on measurement chamber style designed to minimize backscatter • Delivery time per the manufacturer

For more information, visit www.standardimaging.com.

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Third-party AccessoriesStandard Imaging Fixture and Ion Chamber

Qty.* Product # Components of Accessory

1 71737 Standard Imaging Surface Applicator In-Air Calibration Fixture for Varian Applicators

1 92736 Small ion chamber for Varian Applicators (Exradin A20, 0.074 cc)

1 72272 Exradin A20 300keV build up cap 0.5mm thick window, C552

1 80066-P Calibration, Therapy, UW250-M, Tungsten Anode X-Ray

1 80033 Cesium Calibration for Therapy Ion Chamber, First Point

*Quantity indicated is the quantity included with the kit. Quantity associated with each part number is one (1) unless otherwiseindicated in the product description.

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Varian Medical Systems

BrachyTherapy Offi ces USA BrachyTherapy Head Offi ce Charlottesville, VA Tel: 888.666.7847 Fax: 434.244.7181

BrachyTherapy Offi ces EuropeBrachyTherapyHaan, GermanyTel: 49.2129.551.0Fax: 49.2129.551.5

varian.com/brachytherapy

RAD 4242

© 2013 Varian Medical Systems, Inc. All rights reserved. Varian, and Varian Medical Systems are registered trademarks, and GammaMed, GammaMedplus, and VariSource are trademarks of Varian Medical Systems, Inc. All other trademarks are the property of their respective owners.

9/2013 (250)

Intended Use SummaryVarian Medical Systems’ software, afterloaders, and applicators are intended to provide radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated. 

SafetyRadiation treatments may cause side eff ects varying with the part of the body being treated. This may include, but not be limited to irritation to the mouth, respiratory system, digestive system, genitourinary system, fatigue, nausea, skin irritation, and hair loss. In a minority of patients, side eff ects can be severe. Typically, the side eff ects are temporary. Radiation treatment is not appropriate for all cancers. Treatment sessions may vary in complexity and time. Patients should discuss the treatment and side eff ects with their physicians before starting. Side eff ects of applicator placement and/or implantation may occur. These side eff ects may include, but are not be limited to, localized discomfort, bleeding, and infection or other localized side eff ects based on the location the applicator is placed. Patients should discuss the treatment and side eff ects with their physicians before starting.

Medical Advice DisclaimerVarian as a medical device manufacturer cannot and does not recommend specifi c treatment approaches. Individual treatment results may vary.