Standard CT-MR Applicator Set User Manual

Contact Information

Contact Information MANUFACTURER Nucletron B.V Subsidiary of Elekta AB Waardgelder 1 3905 TH VEENENDAAL The Netherlands Tel.: +31 318 557 133

TECHNICAL SUPPORT contact your local representative for technical SUPPORT or visit www.elekta.com

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Contact Information

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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 and ISO 13485. For this reason mark

NUC-T374-12

is used.

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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.

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.

Legal manufacturer

Conventions The following are samples of how warnings, cautions and notes appear throughout this document. The text within the samples explains their intended use: 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.

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Preface

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.

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 © Elekta. All rights reserved. No part of this document may be reproduced in any form without written permission from the copyright holder. Trademarks All trademarks of Elekta products are the property of Elekta. Acknowledgment of other trademarks Elekta acknowledges the trademarks and registered trademarks of other manufacturers that we use in this document. Referenced documents Elekta does not supply all the documents that we refer to in this document with the equipment. Elekta reserves the right to make the decision on which of the documents we supply with the equipment.

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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 ...1 Manufacturer ...1 Related Publications ...1 Intended Use ...2 Compatible Devices ...2 Contraindications ...3 Adverse Reactions ...3 Product Description ...3 8.1 Product Identification and Revisions ...5 8.2 Technical Data ...6 8.3 Relevant Standards ...6 8.4 Graphical Symbols for Medical Device Labeling ...6 8.5 Magnetic Resonance Imaging (MRI) ...7 Life Expectancy ...7 Traceability ...9 Transport and Storage Conditions ...9 Single Use and Reusable Parts ...9 Sterile and Non-sterile Delivered Parts ...9 Cleaning and Sterilization...10 14.1 Pre-processing ...10 14.2 Cleaning and Disinfection ...10 14.2.1 Brushing ...10 14.2.2 Cleaning ...10 14.2.3 Rinsing ...11 14.2.4 Drying ...11 14.3 Sterilization ...11 14.3.1 Materials ...12 14.3.2 Product Revisions...13 14.3.3 Recommended Sterilization Processes ...13 14.3.4 Details of the processes ...14 14.4 Post-processing...15 Preparations for Use ...16 Inspection of the Parts before Use ...17 Insertion Procedure ...17 Immobilize the Applicator ...20 Imaging Procedures ...21 19.1 X-Ray Imaging...21 19.2 MR Imaging ...23 microSelectron; Distance to most Distal Dwell Position ...24 20.1 Using X-Ray Catheters...24 20.1.1 Markers ...25 20.1.2 Identification of the Channels with Markers ...26 20.1.3 Identification of the Most Distal Dwell-Position ...26 20.1.4 Distance of Applicator Tip to Most Distal Dwell-Position ...27 20.2 Using MR Line Markers ...27 20.2.1 Markers ...28

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22. 23.

24. 25. 26. 27.

28.

x

20.2.2 Identification of the Channels with Markers ...29 20.2.3 Identification of the Most Distal Dwell-Position ...29 20.2.4 Distance of Applicator Tip to Most Distal Dwell-Position ...29 Flexitron; Distance to most Distal Dwell Position ...30 21.1 Using X-Ray Catheters...30 21.1.1 Markers ...31 21.1.2 Identification of the Channels with Markers ...32 21.1.3 Identification of the Most Distal Dwell-Position ...32 21.1.4 Distance of Applicator Tip to Most Distal Dwell-Position ...33 21.2 Using MR Line Markers ...33 21.2.1 Marker ...34 21.2.2 Identification of the Channels with Markers ...35 21.2.3 Identification of the Most Distal Dwell-Position ...35 280.5 mm ...35 21.2.4 Distance of Applicator Tip to Most Distal Dwell-Position ...35 Verify Treatment Planning ...35 Treatment ...36 23.1 microSelectron Transfer Tube Identification ...36 23.2 Flexitron Transfer Tube Identification ...37 23.3 Applicator Tube Identification ...37 23.4 Connect the Transfer Tubes ...38 23.5 Check the Connections ...39 23.6 Treatment Execution ...39 Removal Procedures ...39 Disassembly Procedures...40 Disposal Procedures ...40 Quality Assurance ...41 27.1 Inspection Before Use ...41 27.2 Regular inspection...41 27.3 Calibration of the X-Ray Markers ...42 27.4 Check the length of the Transfer Tubes ...42 Parts List ...43 28.1 Standard CT/MR Applicator Set ...43 28.2 Optional Parts...43 28.3 Required Accessories ...44

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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 See “How to contact Nucletron Offices” at the start of this manual for all manufacturer's and branch offices data.

3. Related Publications Title

Part number

microSelectron Digital - V3 User Manual

190.050

microSelectron Digital - V3 Reference Manual

190.051

microSelectron-V2 User Manual

092.515

Flexitron HDR User Manual

777.00160MAN

Flexitron PDR User Manual

777.00143MAN

Smit Sleeve CT/MR User Manual

090.712

X-Ray Catheter Set CT/MR GYN for microSelectron User Manual

090.715

X-Ray Catheter Set CT/MR GYN for Flexitron User Manual

777.00138MAN

MR Line Markers User Manual

777.00081MAN

Transfer Tube Set CT/MR GYN for microSelectron User Manual

090.685

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User Manual Title

Part number

Transfer Tube Set CT/MR GYN for Flexitron User Manual

777.00137MAN

Source Position Check Ruler for microSelectron User Manual

090.689

Source Position Check Ruler for Flexitron User Manual

777.00110MAN

Autoradiograph Check Device User Manual

090.600

CT/MR Applicator Clamp User Manual

090.716

4. Intended Use The Standard CT/MR Applicator is intended for gynecological brachytherapy for cancer treatment of the cervix and endometrium. The device is intended to be used with the following Nucletron afterloaders:  

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

Please refer to the applicable user manuals.

5. Compatible Devices The Standard CT/MR applicator is compatible with the following Nucletron transfer tubes and X-ray catheters: Compatible Transfer Tubes: Description

Part number

Compatible Afterloader

Transfer Tube Set CT/MR GYN for microSelectron

111.006

microSelectron

Transfer Tube Set CT/MR GYN for Flexitron

111.650

Flexitron

Description

Part number

Compatible Afterloader

X-ray Catheter Set CT/MR GYN for microSelectron

101.065

microSelectron

X-ray Catheter Set CT/MR GYN for Flexitron

110.400

Flexitron

Compatible X-ray Catheters:

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User Manual Compatible MR Line Markers: Description

Part number

Compatible Afterloader

MR Line Markers

110.290

microSelectron and Flexitron

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 implantation procedure to be used.

7. Adverse Reactions There are no known adverse reactions.

8. Product Description Model Part number 101.020

Standard CT/MR Applicator Set

Description The Standard CT/MR Applicator Set is a gynecological applicator for brachytherapy procedures. The applicator uses an intrauterine tube and two ovoid tubes. The tubes guide the radioactive source of the afterloader where treatment is to be applied. Transfer tubes are required to connect the applicator to the afterloader. The applicator is MR-safe. Its design uses composite fiber tubing, to eliminate distortion on CT or MR imaging. This enables conformal treatment planning with the use of transversal slices. The external diameter of the intrauterine tube is 6 mm. An optional thin intrauterine tube with an external diameter of 4 mm is available. The diameter is larger at the tube joints. Optional Smit Sleeves CT/MR are available for easy cervical insertion of the applicator. The optional Applicator Clamp (part number 189.931 or part number 189.932) can assist in immobilization of the applicator; see section 18.

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User Manual All materials of the Standard CT/MR Applicator which are in contact with the patient are biocompatible. The product is delivered non-sterile. The applicator set is delivered with spare knobs for the screw of the fixation mechanism. It is recommended to have at least one spare sterile knob available during treatment. If a knob becomes non-sterile, then a spare sterile knob can be used.

The following figures give an overview of the applicator and its parts. Standard CT/MR Applicator Set 1: 2: 3: 4:

Ovoid Tube Right Fixation screw to fixate tubes Ovoids Ovoid Tube Left

5: Fixation mechanism 6: Intrauterine Tube with standard tube diameter of 6 mm with fixed cervical stopper 7: Sterilization caps

7

1 2

6

3

5 4

Figure 1: The Standard CT/MR Applicator Set

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User Manual Standard CT/MR Applicator Set with optional Intrauterine Tube (4 mm) 1: 2: 3: 4:

Ovoid Tube Right Cervical Stopper Rectal Retractor Ovoid Tube Left

5: Intrauterine Tube (4 mm) 6: Sterilization caps

6 1

Optional Intrauterine Tube with 4 mm outer diameter

5 4 2

3 Figure 2: The Standard CT/MR Applicator Set with optional Intrauterine Tube (4 mm).

8.1

Product Identification and Revisions

On most applicator parts, the part-number is engraved, for example 101.039-06. In this number, the '06' indicates the 'revision' of the product. Revision means that a change or improvement is introduced, for example a change in material, without affecting the form, fit and function of the part. For products produced before ca. 2005, there is no revision number engraved, for example only the number 101.039 is engraved. Some very small parts do not have a part-number engraved at all. 101.039 – 06 Part number

Revision level

The revision of parts has consequences for example for cleaning and sterilization. Where necessary, the consequences of part revision-levels are explained in this manual. The following figure shows an example product evolution. No Revision

Revision 03

Revision 04

Revision 05

Revision 06

Timeline Figure 3: Product Evolution by Revisions; example.

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User Manual 8.2

Technical Data

External diameter of the intrauterine tube: 6 mm. An optional thin intrauterine tube with an external diameter of 4 mm is available. The diameter is larger at the tube joints. The intrauterine tube (6 mm) is available with tube-end lengths of 40 mm, 50 mm and 60 mm. The optional intrauterine tube (4 mm) is available with an angle of 40º and a length of 50 mm.

8.3

Relevant Standards

MDD classification: Accessory to a Class IIb device. FDA classification: Accessory to a Class II device.

8.4

Graphical Symbols for Medical Device Labeling

Label

Description Sterilized with ethylene oxide gas Lot number Do not reuse (for single use only) Attention, consult accompanying documentation Date of manufacturing (year-month)

Use by

Do not use after the date shown (year-month) Reference number

F

French size MR Safe

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User Manual 8.5

Magnetic Resonance Imaging (MRI)

The following table lists the MR classification of the product for MR imaging. Part-description

MR classification

Standard CT/MR Applicator Set

MR Safe

MR Safe All parts of the Standard CT/MR Applicator Set that are intended to be inserted into the patient are made out of non conductive and non magnetic materials and are MR safe. The following parts that are used in combination with the applicator are not allowed to be in or being in the vicinity of the MRI device:       

Screwdriver Cleaning brushes CT-markers X-ray catheters Transfer tubes Stainless steel applicator clamp (part numbers 038.000 / 038.050 / 068.025), and so on.

As applicator clamp, use the CT/MR Applicator Clamp part number 189.931 or 189.932, see the applicable User Manual 090.716. MR Line Markers MR Line Markers are available to make the applicator visible on MR images. The line markers can also be used for the optional intrauterine tubes (4 mm). Note that only products with revision level 06 and higher are suitable for the line markers. Products with revision level 03, 04, 05 or no revision level are not suitable for the line markers because these tubes are too narrow for the line markers.

9. Life Expectancy Main parts: Part no.

Description

Life Expectancy

101.020

Standard CT/MR Applicator Set

Typical expected reuse life of 3 years. Delivered non-sterile.

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User Manual Optional parts: Part no.

Description

Life Expectancy

110.302

Intrauterine Tube (4 mm), length 50 mm, 40º

Typical expected reuse life of 3 years. Delivered non-sterile.

189.768

Cervical Stopper for the optional Intrauterine Tube (4 mm)

Typical expected reuse life of 3 years. Delivered non-sterile.

189.566 189.676 189.677 189.679 189.681 189.682 189.683

Smit Sleeves CT/MR

Single Use.

For use with Intrauterine Tube (6 mm)

Delivered sterile.

Smit Sleeve length 20 mm Smit Sleeve length 40 mm Smit Sleeve length 60 mm Smit Sleeve length 70 mm Smit Sleeve length 80 mm Smit Sleeve length 100 mm

Single Use. Delivered sterile.

For use with Intrauterine Tubes (4 mm) 101.015

Sterilization Box

Typical expected reuse life of 3 years. Delivered non-sterile.

189.931 189.932

CT/MR Applicator Clamp

These parts have their own user manual

Inspect the items prior to clinical use, see section 16. Required accessories: Part no.

Description

Life Expectancy

101.065 110.400

X-ray Catheter Set CT/MR GYN

These parts have their own user manual

110.287 189.693 189.039

CT-Markers

These parts have their own user manual

110.290

MR Line-marker Set

These parts have their own user manual

111.006 096.048 079.299 111.650

Transfer Tubes

These parts have their own user manual

Inspect the items prior to clinical use, see section 16.

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User Manual 10. Traceability The person in charge at the hospital should keep a record of the product (including the reference and lot number), so that changes or withdrawals can be handled promptly.

11. Transport and Storage Conditions Store the product in a dry place and in the unopened original packing. Do not use the product after the expiry date. Temperature Range:

0C - 50C (32F - 122F)

Humidity:

Non-condensing

Pressure Range:

Atmospheric pressure with normal variations

12. Single Use and Reusable Parts Single Use Parts Single use parts should not be reused. Before clinical use, inspect the parts for any shipping damage. Damaged parts should be removed from clinical use. Reusable Parts Reusable parts are designed for reuse (verify the life expectancy, see Section 8). Before clinical use, inspect the parts for any indication of unacceptable deterioration, dullness, cracking, staining, corrosion, discoloration and bending. Inspect joints and connections on play, strength or other forms of degradation. Unacceptable parts should be removed from clinical use. Do not repair the product or sharpen the points of obturators and needles.

WARNING Do not reuse devices that were used for patients indicated with CreutzfeldtJakob disease.

13. Sterile and Non-sterile Delivered Parts Sterile Delivered Parts Sterile delivered parts should not be reused, or used after the expiry date.

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User Manual Inspect the sterile package for seal integrity and damage to the package before opening and using the product. If biological contamination is suspected because of a defective sterile package, then the parts can be returned to Nucletron for replacement (replacements are subject to Nucletron’s terms and conditions of sale; Nucletron does not accept returned parts for re-sterilization). Nucletron cannot accept the responsibility for re-sterilization. Non-sterile Delivered Parts Verify if the part is clean, disinfected and sterile before use. Refer to the cleaning and sterilization section for correct instructions.

14. Cleaning and Sterilization 14.1

Pre-processing

1. Visual inspection of the product is required before use. 2. If any manufacturing residue exists, follow the defined cleaning instructions. 3. The parts that are for single use do not require cleaning before sterilization. 4. Before clinical use the product must be sterilized, following the defined procedure.

14.2

Cleaning and Disinfection

14.2.1 Brushing If necessary, clean the outside of the parts and the holes, by brushing with a mild detergent solution (without alcohol) until all visible soil is removed. It is best to use an enzymatic detergent (e.g. Cidezyme, Enzol). 14.2.2 Cleaning Clean the parts in an automatic washer/disinfector or an ultrasonic cleaning device. Use cleaning agents or disinfectants without alcohol. Precise instructions cannot be given, because of variations in cleaning equipment, cleaning agents and disinfectants. If you need further information about the procedures to be used, contact the manufacturer of the cleaning equipment, cleaning agents and disinfectants. Use chemical indicators or other acceptable methods to validate the effectiveness of the cleaning and disinfection. Only use cleaning equipment, cleaning agents, disinfectants and methods that comply with national laws.

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User Manual Recommended minimum sterility levels: Contact Type

Minimum Sterility Level

Contact with intact skin

Medium-level disinfection.

Contact with intact mucous membranes

High-level disinfection. Nucletron recommends sterilization whenever possible.

Close contact with non-intact skin or mucous membranes. Inserted in the sterile area of the body (interstitial).

Sterilization. Disinfectants are unacceptable for sterilization purposes.

14.2.3 Rinsing 1. Rinse all parts in distilled water for 5 minutes.

WARNING Insufficient rinsing of the product after cleaning and disinfection can cause irritation to tissue. When the product is reused for (potentially) known immuno-compromised patients, Nucletron recommends rinsing of the product with sterile water after cleaning and disinfection. Do not reuse devices that were used for patients indicated with CreutzfeldtJakob disease.

14.2.4 Drying 1. All parts should be air-dried or wiped off with a Kleen-wipe. 2. After all parts are dry they should be placed within the appropriate sterilization container.

14.3

Sterilization

Nucletron recommends certain sterilization methods in a general way (see the following sections). For example, autoclaving for 3 minutes at 134°C and 2 bar. In a general way, those recommended methods are suitable and validated for the product. Precise instructions for sterilization and aeration cannot be given, because of variations in hospital sterilizers. The specific process (different process phases) to carry out the recommended methods, however, can differ per hospital sterilizer. For example, autoclaving for

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User Manual 3 minutes at 134°C and 2 bar can take place with different process phases (i.e. how quickly is the situation of 134°C and 2 bar reached?, is there a vacuum phase? etc.). If further information is necessary regarding the specific process to be used, contact the manufacturer of the sterilizer. Use biological indicators or other acceptable methods to validate the effectiveness of the specific process of the hospital sterilizer. Only use sterilization equipment that complies with national laws. 14.3.1 Materials The Standard CT/MR Applicator parts consist of the following materials. Part-description:

Material:

Intrauterine Tubes

PPSU / Epoxy Poly-vinylester Glass Fiber

Ovoid Tubes

PPSU / Epoxy Poly-vinylester Glass Fiber

Ovoid Pairs

PPSU

Fixation Mechanism for Ovoid Tube

PPSU

Rectal Retractor

PPSU

Screwdriver

Titanium

For the relation between part-descriptions and part-numbers see the parts list in section 28).

Note: Older revisions of parts can be made out of PSU instead of PPSU. See also the following sections.

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