Vaginal CT-MR Multi Channel Applicator User Manual

How to contact Nucletron Offices

HOW TO CONTACT NUCLETRON OFFICES Unless otherwise stated the service dispatch call number is the main telephone number.

BeNeLux

Nucletron B.V. PO Box 930 3900 AX VEENENDAAL Waardgelder 1 3905 TH VEENENDAAL The Netherlands Tel.: +31 318 557 133 Service: +31 318 557 111 E-mail [email protected] Web site: www.nucletron.com

Nucletron B.V. PO Box 930 3900 AX VEENENDAAL Waardgelder 1 3905 TH VEENENDAAL The Netherlands Tel.: +31 318 557 236 Fax: +31 318 557 190 Service: +31 318 557 111 E-mail [email protected] Web site: www.nucletron.com

Germany Theranostic Medizintechnik GmbH Obere Dammstrasse 8-10 D-42653 Solingen Tel.: +49 212 5875 153 Fax: +49 212 5875 269 Service: +49 212 5875 333 E-mail: [email protected] Web site: www.theranostic.de

Italy Nuclital srl Viale Elvezia no. 52 20900 (MB) Tel.: +39 039 322848 / 323148 Fax: +39 039 323913 E-mail: [email protected]

Europe / Middle East and Africa

Head Office and Manufacturer:

France Nucletron S.A.S. 17/19 Boulevard du Mont d’Est Immeuble Le Michel Ange 93160 NOISY LE GRAND Tel.: +33 148 15 50 64 Fax: +33 143 03 28 15 E-mail: [email protected]

Russia Nucletron Representation Office Moscow Krzhizanovskogo str. B 14 b.,3 117218 Moscow Tel.: + 74 95 363 5188 Fax: + 74 95 363 5188 E-mail: [email protected]

United Kingdom

Spain

Nucletron UK Ltd. Nucletron House Chowley Oak Tattenhall CHESTER CH3 9EX Tel.: +44 1 829 771111 Fax: +44 1 829 770979 E-mail: [email protected]

Nucletron S.A. Avda. de Castilla, 2 Parque Empresarial San Fernando e Edificio Francia, Planta 2 , Esc. A 28830 San Fernando de Henares (Madrid) Tel.: +34 918 250 067 Fax: +34 918 250 069 Service: +34 918 250 068 E-mail: [email protected]

Sweden Nucletron Scandinavia AB Box 1704 Klostergatan 12 SE–751 47 Uppsala Sweden Tel: +46 18 565 000 Fax: +46 18 565 011 E-mail: [email protected]

NUC-T380-30

How to contact Nucletron Offices

HOW TO CONTACT NUCLETRON OFFICES USA Nucletron 7021 Columbia Gateway Drive Suite 200 Columbia, MD 21046 Tel.: +1 800 336 2249 Tel.: +1 410 312 4100 Fax: +1 443 769 1570 E-mail: [email protected]

North and South America

Unless otherwise stated the service dispatch call number is the main telephone number.

Canada Nucletron Canada Inc. Gateway Business Building 2 320 March Road, suite 100 Kanata, Ontario K2K 2E3 Canada Tel: +1 800 826 2258 / +1 613 886 1103 Fax: +1 613 592 6559 E-mail: [email protected]

Australia

Nucletron Asia Pacific Ltd. Room 1005, Tower 2, Silvercord, 30 Canton Road, Tsim Sha Tsui, Kowloon, HONG KONG Tel.: +852 2311 2683 / 2684 / 3025 Fax: +852 2311 3672 E-mail: [email protected]

Nucletron Pty. Limited 1b Little Commodore Street Newtown NSW 2042 Sydney Tel.: +61 2 9517 1300 Fax: +61 2 9517 1311 Email: [email protected]

China

India

Nucletron Asia Pacific Ltd. Beijing Representative Office Room 2008, Tower A, North Ring Center, No.18, Yu Min Road Xicheng District, Beijing 100029, China Tel.: +86 10 8225 4965 / 4967 Fax: +86 10 8225 4963 E-mail: [email protected] Web site: www.nucletron.com

Nucletron India Pvt Ltd. No. 3, D’Silva Road Mylapore Chennai 600 004 Tel.: +91 44 24992877 / 24991871 Fax: +91 44 24991967 E-mail: [email protected] Web site: www.nucletron-india.com

Nucletron Asia Pacific Ltd. Shanghai Representative Office Room 1704, Wangjiao Plaza, No.175, Yan An East Road, Huangpu District, Shanghai, 200002, China Tel.: +86 21 6373 4380 / 4381 Fax: +86 21 6373 4383 E-mail: [email protected] Web site: www.nucletron.com

Asia Pacific

Hong Kong

Singapore Nucletron Asia Pacific Ltd. Singapore Representative Office 3 Science Park Drive The Franklin # 02 – 12/25 Suite 38 Singapore 118223 Tel.: +65 6779 1248 Fax: +65 6778 5238 E-mail: [email protected]

Your Distributor / Agent

NUC-T380-30

Preface

Preface Identification Manuals are identified by a part number. There are two types of part numbers: Example 1: Example 2

The part number is printed at the bottom of the title page. Numbers printed on other pages are for internal revision control and may differ.

CE Classification Manuals made for products that have been CE (Conformité Européenne) marked have the CE mark on the front page. The number behind the CE Mark defines the responsible notified body. Nucletron systems are classified according to IEC 60601-1 as Class I, type B. Nucletron systems meet the relevant provisions of the European Medical Device Directive 93/42/EEC or the European Active Implantable Medical Device Directive 90/385/EEC; this is based on conformity of the products and the quality system according to ISO 9001:2008 and ISO 13485:2003. For this reason mark

NUC-T374-07

is used.

v

Preface

Symbols Symbol

Location: Near or on the type identification plate.

Meaning

Remarks

Symbol for separated collection of electrical and electronic equipment per Directive 2002/96 of the European Parliament and the Council of the European Union (Directive on Waste of Electrical and Electronic Equipment WEEE). If applicable to the type of device, it indicates legally imposed obligations within EU member states, Iceland, Norway and Switzerland when the equipment is disposed of, at the end of its life-time. Legal manufacturer

Owners of marked equipment should contact the organization that imported the equipment into their country, when they want to dispose of the equipment, at the end of its lifetime. The Directive prioritizes re-use of equipment over reuse of components over re-use of materials over disposal as waste. Article 5 part 2d allows producers to decline the return of any used equipment that is or may be biologically or radiologically contaminated.

Conventions Throughout this manual certain conventions are used. These are Warnings, Cautions and Notes. They provide a means of prioritizing information to be brought to the attention of the user. They are given as follows: Warning: Designates a possibly dangerous situation. Non-observance may lead to death or the most severe injuries

Caution: Designates a possibly harmful situation. Non-observance may lead to minor injuries or damage to the product.

Note: Designates a possibly harmful situation. Non-observance may lead to damage to the product or the environment.

Precautions The user is expected to use the product (soft and hardware) in accordance with the instructions given in this manual, which must be read before the system is used. Any unauthorized deviation from the procedures laid down in this manual can affect the contractual obligations between purchaser and vendor. Warning: Do not modify any part of Nucletron supplied computer's hardware, software or software configuration. Installing or running an application that has not explicitly been approved by Nucletron may compromise patient safety and will result in termination of all warranty and service contracts.

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Preface

Warning: The Nucletron products are designed for use and maintenance using only parts available from Nucletron. No liability for failure can be accepted by Nucletron through the use of parts obtained from other suppliers unless written permission is obtained from Nucletron.

Copyright All rights reserved. No part of this manual may be reproduced or transmitted in any form whatsoever, including photocopying and recording without written permission of the copyright holder: Nucletron B.V., PO Box 930, 3900 AX VEENENDAAL, The Netherlands.

Concerning this Publication Information contained in this publication is subject to change without notice. Whenever the equipment is delivered with a documentation medium such as a CD or DVD, the user shall always check the medium for latest information. This information is part of Release Notes and Document Upgrade files. Neither Nucletron B.V. and its subsidiaries nor anyone else who has been involved with the development, production or delivery of the documentation be liable for any special, incidental or consequential damages, whether based upon breach of warranty, breach of contract, negligence, strict liability in tort or any other legal theory. This manual was originally drafted in the English language.

NUC-T374-07

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Preface

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User Manual Table of Contents 1. 2. 3. 4. 5. 6. 7. 8.

9. 10. 11. 12.

13.

14.

15. 16. 17.

18.

19.

20.

Important Notices ... 12 Manufacturer ... 12 Related Publications ... 12 Intended Use ... 13 Compatible Devices ... 13 Contraindications ... 15 Adverse Reactions ... 15 Product Description ... 15 8.1 Technical Data ... 19 8.2 Relevant Standards ... 21 8.3 Graphical Symbols for Medical Device Labeling ... 21 Life Expectancy ... 22 Traceability ... 23 Transport and Storage Conditions ... 23 Single Use and Reusable Parts... 23 12.1 Single Use Parts ... 23 12.2 Reusable Parts ... 23 Sterile and Non-sterile Delivered Parts ... 24 13.1 Sterile Delivered Parts ... 24 13.2 Non-sterile Delivered Parts... 24 Cleaning and Sterilization ... 24 14.1 Pre-processing ... 24 14.2 Cleaning and Disinfection ... 24 14.2.1 Brushing ... 24 14.2.2 Cleaning ... 24 14.3 Rinsing ... 25 14.4 Drying ... 25 14.5 Sterilization ... 26 14.5.1 Details of the processes ... 27 14.6 Post-processing ... 27 Preparation for Use ... 27 Inspection of the Parts before Use ... 29 Assemble the Applicator ... 30 17.1 Select the Cylinder Diameter ... 30 17.2 Assemble the Cylinder ... 31 17.3 Place the Catheters with collar (optional) ... 33 17.4 Select the Intravaginal Tube or Intrauterine Tube (optional) ... 35 17.5 Assemble the Intravaginal Tube and the Cylinder ... 36 Insertion Procedures ... 37 18.1 Insert the Applicator with Intravaginal Tube... 37 18.2 Insert the Applicator with Intrauterine Tube ... 38 Immobilize the Applicator ... 39 19.1 Immobilize the applicator with the Perineal Bar ... 39 19.2 Immobilize the applicator with the Applicator Clamp ... 41 Imaging Procedures ... 42 20.1 Channel Overview microSelectron ... 43

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User Manual 20.2 20.3

21.

22.

10

Channel Overview Flexitron ... 44 X-Ray Imaging ... 45 20.3.1 X-Ray Catheters for the Intravaginal Tube or Intrauterine Tube ... 45 20.3.2 X-Ray Imaging of the Intravaginal Tube or Intrauterine Tube .. 46 20.3.3 X-Ray Catheters for the Catheters with collar 6Fx293 mm ... 47 20.3.4 X-Ray Imaging of the Catheters ... 47 20.4 CT Imaging ... 47 20.4.1 CT Marker Sets for the Catheters with collar 6Fx293 mm ... 48 20.4.2 CT-Imaging Procedure ... 48 20.5 Magnetic Resonance Imaging (MRI)... 49 20.5.1 MR Imaging of the Applicator Cylinder ... 50 20.5.2 MR Imaging of the CT/MR Intravaginal Tube or CT/MR Intrauterine Tube ... 51 Treatment Planning Information for microSelectron ... 53 21.1 Using X-Ray ... 53 21.2 X-ray Catheters for the CT/MR tubes ... 53 21.2.1 Markers ... 54 21.2.2 Identification of the Channel with Markers ... 54 21.2.3 Identification of the Most Distal Dwell-Position ... 55 21.3 X-ray Catheters for the Catheters with collar 6Fx293 mm ... 56 21.3.1 Markers ... 57 21.3.2 Identification of the Channels with Markers ... 58 21.3.3 Identification of the Most Distal Dwell-Position ... 59 21.4 Using CT ... 60 21.5 CT-Markers for the Catheters 6Fx293 mm ... 61 21.5.1 Identification of the Channels with Markers ... 62 21.5.2 Identification of the Most Distal Dwell-Position ... 62 21.6 Using MRI ... 63 21.7 MR Line Marker for the CT/MR tubes ... 63 21.7.1 Markers ... 63 21.7.2 Identification of the Channel with Markers ... 63 21.7.3 Identification of the Most Distal Dwell-Position ... 64 Treatment Planning Information for Flexitron... 66 22.1 Using X-Ray ... 66 22.2 X-ray catheters for the CT/MR tubes ... 66 22.2.1 Markers ... 66 22.2.2 Identification of the Channel with Markers ... 67 22.2.3 Identification of the Most Distal Dwell-Position ... 68 22.3 X-ray Catheters for the Catheters with collar 6Fx293 mm ... 69 22.3.1 Markers ... 69 22.3.2 Identification of the Channels with Markers ... 69 22.3.3 Identification of the Most Distal Dwell-Position ... 70 22.4 Using CT ... 71 22.5 CT-Markers for the Catheter with collar 6Fx293 mm ... 72 22.5.1 Identification of the Channels with Markers ... 73 22.5.2 Identification of the Most Distal Dwell-Position ... 73 22.6 Using MRI ... 74

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23.

24. 25. 26. 27.

28.

MR Line Marker for the CT/MR tubes ... 74 22.7.1 Markers ... 74 22.7.2 Identification of the Channel with Markers ... 74 22.7.3 Identification of the Most Distal Dwell-Position ... 75 Treatment Delivery ... 77 23.1 Verify Treatment Planning ... 77 23.2 Treatment ... 77 23.3 Connect the Transfer Tubes ... 77 Removal Procedures ... 78 Disassemble the applicator... 79 Disposal Procedures ... 81 Quality Assurance ... 81 27.1 Inspection Before Use ... 81 27.2 Regular Inspection ... 81 27.3 Calibration of the CT- and X-Ray-Markers ... 82 27.4 Calibration of the MR Line Markers... 82 27.5 Check the Length of the Transfer Tubes ... 82 Parts List... 83 28.1 Main parts Vaginal CT/MR Multi Channel Applicator Set... 83 28.2 Optional parts ... 85 28.3 Required accessories ... 87 28.3.1 Transfer Tubes ... 88 28.3.2 X-Ray Catheters for CT/MR Tubes ... 88 28.3.3 X-Ray Catheters for the Catheters with collar 6Fx293 mm ... 89 28.3.4 CT Markers ... 89 28.3.5 MR Line Markers... 89

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User Manual

1. Important Notices Nucletron’s terms and conditions of sale apply.

WARNING Carefully read all instructions before use. Observe all cautions and warnings throughout these instructions. Failure to do so may result in complications. The product should only be used by qualified physicians, trained in Brachytherapy techniques. The physician is responsible for its proper clinical use and the prescribed radiation dose. Verify all product components are clean, sterile and undamaged before use. Incorrect cleaning and sterilization can result in clinical complications.

CAUTION Federal (U.S.) and State laws restrict the sale of this product to a physician or on a physician's order.

2. Manufacturer The product is manufactured by Nucletron (address: Waardgelder 1, Veenendaal, The Netherlands). To request additional information, please contact your Nucletron branch office or agent. See "How to contact Nucletron offices" at the start of this manual for all manufacturer's and branch offices data.

3. Related Publications For microSelectron Title

Part number

microSelectron Digital – V3 User Manual

190.050

microSelectron-V2 User Manual

092.515

Transfer Tube Set GYN for microSelectron User Manual

090.684

Transfer Tube Set for Flexibles for microSelectron User Manual

090.687

X-Ray Catheter Set GYN for microSelectron User Manual

090.715

Autoradiograph Check Device User Manual

090.600

Table 3-1 microSelectron Related Publications.

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User Manual For Flexitron Title

Part number

Flexitron HDR User Manual

777.00103MAN

Flexitron PDR User Manual

777.00143MAN

Transfer Tube Sets for Flexitron User Manual

777.00109MAN

X-Ray Catheter Set GYN for Flexitron User Manual

777.00138MAN

X-Ray Markers for Flexitron User Manual

777.00111MAN

Source Position Check Ruler (SPCR) for Flexitron User Manual

777.00110MAN

Table 3-2 Flexitron Related Publications.

General Title

Part number

CT Expansion Set User Manual

777.00179MAN

Catheter Set with Collar 6Fx293 mm

777.00172MAN

CT Marker Set

090.702

MR Line Markers Set

777.00081MAN

Smit Sleeve User Manual

090.712

CT/MR Applicator Clamp User Manual

090.716

Table 3-3 General Related Publications.

4. Intended Use The Vaginal CT/MR Multi Channel Applicator Set is intended for gynecologic Brachytherapy treatment of the vagina, cervix and endometrium. The device is intended to be used with the following Nucletron afterloaders: ● ●

microSelectron-HDR / PDR Digital, V3 and V2, Flexitron HDR / PDR.

Please refer to the applicable user manuals.

5. Compatible Devices The Vaginal CT/MR Multi Channel Applicator Set is compatible with the Nucletron transfer tubes and markers listed in Table 5-1 and Table 5-4:

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User Manual microSelectron Compatible Transfer Tubes Part number

Description

Compatible Afterloader

111.006

Transfer Tube Set CT/MR GYN for CT/MR tubes

microSelectron

111.031

Transfer Tube Set for 6F Catheters (channel 1-9)

microSelectron

111.041

Transfer Tube Set for 6F Catheters (channel 10-18)

microSelectron

Table 5-1 microSelectron Compatible Transfer Tubes.

microSelectron Compatible X-Ray Catheters, CT Markers and MR Markers Part number

Description

Compatible Afterloader

101.065

X-Ray Catheter Set CT/MR GYN for CT/MR tubes

microSelectron

089.089 089.090

X-Ray Catheter Set for Catheters 6F

microSelectron

110.287 189.693

CT Markers for Catheters 6F

microSelectron

110.290

MR Line Markers for CT/MR tubes

microSelectron

Table 5-2 microSelectron Compatible Markers.

Flexitron Compatible Transfer Tubes Part number

Description

Compatible Afterloader

111.650

Transfer Tube Set CT/MR GYN for CT/MR tubes

Flexitron

137.094

Transfer Tube Set for 6F Catheters (channel 1-10)

Flexitron

137.095

Transfer Tube Set for 6F Catheters (channel 11-20)

Flexitron

Table 5-3 Flexitron Compatible Transfer Tubes.

Flexitron Compatible X-Ray Catheters, CT Markers and MR Markers Part number

Description

Compatible Afterloader

110.400

X-Ray Catheter Set CT/MR GYN for CT/MR tubes

Flexitron

089.089 089.090

X-Ray Catheter Set for Catheters 6F

Flexitron

110.287 189.693

CT Markers for Catheters 6F

Flexitron

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User Manual Flexitron Compatible X-Ray Catheters, CT Markers and MR Markers Part number

Description

Compatible Afterloader

110.290

MR Line Markers for CT/MR tubes

Flexitron

Table 5-4 Compatible Markers.

6. Contraindications There are no known general contraindications for using the product. The particular medical condition and anatomy of the patient, however, may dictate the procedure to be used.

7. Adverse Reactions There are no known adverse reactions.

8. Product Description The Vaginal CT/MR Multi Channel Applicator is intended for gynecologic Brachytherapy of the vagina, cervix and endometrium. The applicator consists of a vaginal cylinder with a central channel for vaginal treatment. The vaginal cylinder has surface channels, which are equally spaced around the surface of the vaginal cylinder. The surface channels follow the shape of the cylinder's dome. Treatment catheters with collar can be inserted in the surface channels. By selectively and individually loading these catheters, the dose can be directed laterally and sculpted to the required shape, for instance for treatment of asymmetrically located tumors. The applicator is available in the following sizes, each diameter with a specified number of surface channels: ● ● ● ●

Ø 25 mm diameter with 1 central channel and 6 surface channels. Ø 30 mm diameter with 1 central channel and 8 surface channels. Ø 35 mm diameter with 1 central channel and 8 surface channels. Ø 40 mm diameter with 1 central channel and 10 surface channels (optional).

The applicator’s central channel can be used for vaginal and cervix treatment. A series of intrauterine tubes expand the options of the applicator to intrauterine treatment. The Vaginal CT/MR Multi Channel Applicator can be used in combination with state of the art imaging modalities such as CT and MRI. The set is made of PPSU plastic and is MR safe. 777.00171MAN - 00C

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User Manual The set can be further completed with optional intrauterine tubes, made from the same PPSU plastic. In addition, an optional CT expansion set of Titanium intravaginal and intrauterine tubes is available. Markers for the treatment channels are available to assist in visualization of the source path on the acquired images. The applicator tube and the catheters are connected to the afterloader for treatment by using transfer tubes. All materials of the Vaginal CT/MR Multi Channel Applicator Set are biocompatible. The product is packed in a plastic suitcase and the main parts are delivered nonsterile. The catheters with collar are for single use and are delivered sterile.

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User Manual The following figure gives an overview of the applicator and its parts. Vaginal CT/MR Multi Channel Applicator parts 1. Cylinder Segment Ventral 2. Perineal Bar Lever (optional)

7. Perineal Bar Lever (optional) 8. Fixation Screw

3. Perineal Bar Ventral (optional) 4. Intrauterine Tube (optional)

9. Fixation Cap 10. Surface Channel

5. Cylinder Segment Dorsal 6. Perineal Bar Dorsal (optional)

11. Fill Tube 12. Sterilization Cap 13. Catheter with collar 6F (optional)

Figure 1: Main parts of the Vaginal CT/MR Multi Channel Applicator Set

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User Manual Model The Vaginal CT/MR Multi Channel Applicator is available per individual item and in the following set configuration: Part number

Description

110.750

Vaginal CT/MR Multi Channel Applicator Set.

Optional parts: Part number

Description

110.766

Set of Vaginal CT/MR Multi Channel Applicator components, 40mm

101.003

Intrauterine Tube CT/MR 15˚, 40 mm

101.004

Intrauterine Tube CT/MR 30˚, 60 mm

101.005

Intrauterine Tube CT/MR 45˚, 80 mm

110.787

CT Expansion Set

110.773

Perineal Bar Set

For the parts lists, please refer to section 28.

Required accessories: Part number

Description

110.800

Catheter Set with Collar 6Fx293

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User Manual 8.1

Technical Data

Applicator parts: Intravaginal CT/MR Tube

Cylinder components

Intrauterine Tube CT/MR

Diameter:

Ø 12 mm

External tube length:

286 mm

Internal channel length:

285.5 mm

Length (all diameters):

189 mm

Diameter:

Ø 25 mm, with 6 surface channels

Diameter:

Ø 30 mm, with 8 surface channels

Diameter:

Ø 35 mm, with 8 surface channels

Diameter:

Ø 40 mm, with 10 surface channels *

Diameter main tube:

Ø 12 mm

Diameter intrauterine tube:

Ø 6 mm

Tube angle / tip length:

15˚ / 40 mm

*

Tube angle / tip length:

30˚ / 60 mm

*

Tube angle / tip length:

45˚ / 80 mm

*

External tube length:

288 mm

Internal channel length:

285.5 mm

Required Accessories: Catheter with collar 6F

Outer Diameter:

6 French, or Ø 2 mm

Inner Diameter:

Ø 1.3 mm

External tube length:

293 mm

Internal channel length:

292 mm

Tip length:

1 ± 0.5 mm

* Optional parts, see also section 28.2 Optional parts.

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User Manual The following figures list the typical dimensions in millimeters.

Figure 2: Dimensions of the Cylinders

Figure 3: Dimensions of the Intravaginal CT/MR Tube and Intrauterine CT/MR Tubes

* Optional parts

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Figure 4: Dimensions of the optional Catheter with collar 6Fx293

8.2

Relevant Standards

MDD classification: Accessory to a Class IIb device. FDA classification: Accessory to a Class II device. IEC 60601-1, type B: Protection against electric shock.

8.3

Graphical Symbols for Medical Device Labeling

Label

g D Y N

Description Lot number Do not reuse (for single use only) Attention, consult accompanying documentation Date of manufacturing (year-month) Non sterile

L

Do not use if package is damaged

h

Reference number

F

French size Use by

Do not use after the date shown (year-month) MR safe

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