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Vaginal CT/MR Multi Channel Applicator Set REF 110.750
NUC-T377-01A
User Manual
Doc.No.777.00171MAN - 00C
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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NUC-T374-07
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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NUC-T374-07
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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