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Vaginal CT/MR Applicator Set Part Number101.001
User Manual
090.612ENG –04
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.
Important Notices ...1 Related Publications ...1 Intended Use ...2 Compatible Devices ...2 Contraindications ...3 Adverse Reactions ...3 Product Description ...3 7.1 Product Identification and Revisions ...4 7.2 Technical Data ...5 7.3 Relevant Standards ...5 7.4 Graphical Symbols for Medical Device Labeling ...5 7.5 Magnetic Resonance Imaging (MRI) ...6 Life Expectancy ...7 Traceability ...7 Transport and Storage Conditions ...8 Reusable Parts...8 Non-sterile Delivered Parts ...8 Cleaning and Sterilization...8 13.1 Pre-processing ...8 13.2 Cleaning and Disinfection ...8 13.2.1 Brushing ...8 13.2.2 Cleaning ...9 13.2.3 Rinsing ...9 13.2.4 Drying ...9 13.3 Sterilization ...10 13.3.1 Materials ...10 13.3.2 Product Revisions...11 13.3.3 Recommended Sterilization Processes ...11 13.3.4 Details of the Processes ...12 13.4 Post-processing...13 Preparations for Use ...13 Inspection of the Parts before Use ...14 Insertion Procedure ...15 16.1 Intrauterine Treatment ...15 16.2 Rectal or Vaginal Treatment ...16 16.3 Immobilize the Applicator ...17 Imaging Procedures ...19 17.1 X-Ray Imaging...19 17.2 MR Imaging ...21 microSelectron; Distance to most Distal Dwell Position ...22 18.1 Using X-Ray Catheters...22 18.1.1 Markers ...23 18.1.2 Identification of the Most Distal Dwell-Position ...24 18.1.3 Distance of Applicator Tip to Most Distal Dwell-Position ...24 18.2 Using MR Line Markers ...25 18.2.1 Markers ...25
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20. 21.
22. 23. 24. 25.
26.
x
18.2.2 Identification of the Most Distal Dwell-Position ...26 18.2.3 Distance of Applicator Tip to Most Distal Dwell-Position ...26 Flexitron; Distance to most Distal Dwell Position ...27 19.1 Using X-Ray Catheters...27 19.1.1 Markers ...27 19.1.2 Identification of the Channel with Markers ...28 19.1.3 Identification of the Most Distal Dwell-Position ...29 19.1.4 Distance of Applicator Tip to Most Distal Dwell-Position ...29 19.2 Using MR Line Markers ...31 19.2.1 Markers ...32 19.2.2 Identification of the Most Distal Dwell-Position ...32 19.2.3 Distance of Applicator Tip to Most Distal Dwell-Position ...32 Verify Treatment Planning ...33 Treatment ...33 21.1 Connect the Transfer Tubes ...33 21.2 Check the Connections ...35 21.3 Treatment Execution ...35 Removal Procedures ...35 Disassemble the Applicator ...36 Disposal Procedures ...36 Quality Assurance ...37 25.1 Regular inspection...37 25.2 Calibration of the X-Ray Markers ...37 25.3 Check the length of the Transfer Tubes ...37 Parts List ...38 26.1 Main Parts Vaginal CT/MR Applicator Set...38 26.2 Optional Parts...38 26.3 Required Accessories ...38
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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. 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 User Manual
777.00160MAN
Flexitron Cobalt-60 User Manual
777.00271MAN
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
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
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User Manual 3. Intended Use The Vaginal CT/MR Applicator is intended for gynecological brachytherapy procedures for cancer treatment of the vagina, cervix, endometrium and rectum. 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.
4. Compatible Devices The Vaginal CT/MR applicator is compatible with the following Nucletron transfer tubes, X-ray catheters and MR line markers: 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
Description
Part number
Compatible Afterloader
MR Line Markers
110.290
microSelectron and Flexitron
Compatible X-ray Catheters:
Compatible MR Line Markers:
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User Manual 5. 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.
6. Adverse Reactions There are no known adverse reactions.
7. Product Description Model Part number 101.001
Vaginal CT/MR Applicator Set
Description The Vaginal CT/MR Applicator Set is a gynecological applicator for brachytherapy procedures. The applicator set has intrauterine tubes, a vaginal tube and cylinders in different diameters to optimize the dose distribution and to reduce the mucosal dose. 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 intrauterine tube or vaginal tube guides the radioactive source of the afterloader and provides additional treatment options due to different curvatures. The applicator is connected to the afterloader using transfer tubes. Optional Smit Sleeves CT/MR are available for easy cervical insertion of the applicator; see section 26. The optional Applicator Clamp (part number 189.931 or part number 189.932) can assist in immobilization of the applicator; see section 16.3. The main parts are delivered non-sterile. For the complete parts list, please refer to section 26.
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User Manual Vaginal CT/MR Applicator Set 1: Cylinders 2: Intrauterine Tube 3: Perineal Bar
4: Cylinder fixation 5: Sterilization cap
5
1 4
2 3
Figure 1: The Vaginal CT/MR Applicator Set
7.1
Product Identification and Revisions
On most applicator parts, the part-number is engraved, for example 101.005-06. 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 101.005 is engraved. Some very small parts do not have a part-number engraved at all. 101.005 – 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.
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User Manual The following figure shows an example product evolution. No Revision
Revision 03
Revision 05
Revision 04
Revision 06
Timeline Figure 2: Product Evolution by Revisions; example.
7.2
Technical Data
The typical dimensions are:
Intrauterine Tube diameter 6 mm,
length = 40 mm
Intrauterine Tube diameter 6 mm,
length = 60 mm
Intrauterine Tube diameter 6 mm,
length = 80 mm
Cylinders 20 mm
Cylinders 25 mm
Cylinders 30 mm
Cylinders 35 mm
7.3
Relevant Standards
MDD classification: Accessory to a Class IIb device. FDA classification: Accessory to a Class II device. IEC 60601-1, type B (subclause 5.2): Protection against electric shock.
7.4
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)
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User Manual Label
Description
Use by
Do not use after the date shown (year-month)
REF
Reference number
F
French size MR Safe
7.5
Magnetic Resonance Imaging (MRI)
The following table lists the MR classification of the product for MR imaging. Part-description
MR classification
Vaginal CT/MR Applicator Set
MR Safe
MR Safe All parts of the Vaginal CT/MR Applicator Set that are intended to be inserted into the patient are MR safe. The following parts that are used in combination with the applicator are not allowed to be used in or being in the vicinity of the MRI device:
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. 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.
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User Manual 8. Life Expectancy Main parts: Part no.
Description
Life Expectancy
101.001
Vaginal CT/MR Applicator Set
Typical expected reuse life of 3 years. Delivered non-sterile.
Inspect the items prior to clinical use, see section 15. Optional parts: Part no.
Description
Life Expectancy
189.566
Smit Sleeves CT/MR
Single Use.
For use with Intrauterine Tubes (6 mm)
Delivered sterile.
Sterilization Box
Typical expected reuse life of 3 years.
101.015
Delivered non-sterile.
Inspect the items prior to clinical use, see section 15. Required accessories: Part no.
Description
Life Expectancy
101.065
X-ray Catheter Set CT/MR GYN for microSelectron
These parts have their own user manual
110.400
X-ray Catheter Set CT/MR GYN for Flexitron
These parts have their own user manual
110.290
MR Line-marker Set
These parts have their own user manual
Transfer Tubes
These parts have their own user manual
Inspect the items prior to clinical use, see section 15.
9. 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.
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User Manual 10. Transport and Storage Conditions Store the product in a dry place. Temperature Range: Humidity: Pressure Range:
0C - 50C (32F - 122F) Non-condensing Atmospheric pressure with normal variations
11. 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.
WARNING Do not reuse devices that were used for patients indicated with CreutzfeldtJakob disease.
12. 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.
13. Cleaning and Sterilization 13.1
Pre-processing
1. Visual inspection of the product is required before use. 2. If any manufacturing residue exists, follow the defined cleaning instructions. 3. Before clinical use the product must be sterilized, following the defined procedure.
13.2
Cleaning and Disinfection
13.2.1 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).
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User Manual 13.2.2 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. 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.
13.2.3 Rinsing 1. Rinse all parts in distilled water for 5 minutes (if not automatically rinsed in the washer/disinfector).
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. 13.2.4 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.
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User Manual 13.3
Sterilization
Precise instructions for sterilization and aeration cannot be given, because of variations in hospital sterilizers. 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. The specific process (different process phases) to carry out the recommended methods, however, can differ per hospital sterilizer. For example, autoclaving for 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. 13.3.1 Materials Materials of the Vaginal CT-MR Applicator are as follows: Part-description:
Material:
Vaginal tube
PPSU / Epoxy Poly-vinylester Glass Fiber
Intrauterine Tubes
PPSU / Epoxy Poly-vinylester Glass Fiber
Cylinder Fixation
PPSU
Set of Cylinders
PPSU
Perineal Bar
PPSU
For the relation between part-descriptions and part-numbers see the parts list in section 26.
Note: Older revisions of parts can be made out of PSU instead of PPSU. See also the following sections.
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User Manual 13.3.2 Product Revisions On most applicator parts, the part-number is engraved, for example 101.005-06. In this number, the '06' indicates the 'revision' of the product. For products produced before ca. 2005, there is no revision number engraved, for example only the number '101.005' is engraved. Some very small parts do not have a part-number engraved at all. 101.005 - 03 Part number
Revision level
13.3.3 Recommended Sterilization Processes For the different revision levels of the parts, the following sterilization-processes are valid methods: Part-description:
Valid Sterilization-process: Autoclave 121ºC
Autoclave 134ºC
EtO
Vaginal Tubes
Revision 03 or higher
Revision 06 or higher
All revisions
Intrauterine Tubes
Revision 03 or higher
Revision 06 or higher
All revisions
Cylinder Fixation
Revision 03 or higher
Revision 03 or higher
All revisions
Set of Cylinders
Revision 03 or higher
Revision 03 or higher
All revisions
Perineal Bar
Revision 03 or higher
Revision 03 or higher
All revisions
For the relation between part-descriptions and part-numbers see the parts list in section 26).
WARNING The user is responsible to validate any deviations from the recommended sterilization methods (using other sterilization methods). Nucletron will accept no responsibility for any consequences due to deviation from the defined sterilization methods.
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User Manual Additional explanation of the table: Parts can have a revision number engraved behind the part number. The following situations can exist:
All Revisions (03, 04, 05, 06, 07 or higher) or No Revision: All revisions include the parts that have no revision engraved. The indicated sterilization process is valid for all revisions of the concerning part, including parts without revision engraved or without a part-number engraved. Examples: a) All revisions of the vaginal tubes are suitable for EtO. b) All revisions of the intrauterine tubes are suitable for EtO. For intrauterine tube part 101.005 without revision for example, only EtO is valid and no autoclaving is allowed. Parts without a revision engraved are relative old parts, containing PSU material instead of PPSU and are produced before ca. 2005.
Revision 03 or higher: Examples: a) For the intrauterine tube part 101.005-03 or 101.005-05, only autoclave 121°C is valid and EtO is valid (no autoclave 134°C). b) For the perineal bar part 101.013-03, autoclave 121°C is valid, autoclave 134°C is valid and EtO is valid. Revision 06 or higher: Examples: a) For intrauterine tube part 101.005-06 or 101.005-08, autoclave 121°C is valid, autoclave 134°C is valid and EtO is valid.
13.3.4 Details of the Processes The following specifications are valid for the previous mentioned processes: Steam Autoclaving 121°C - 124°C (250°F - 255°F) If indicated in the table, then steam autoclaving may be used as the manufacturerrecommended re-sterilization method for the part. The sterilization cycle validated by the manufacturer is, for the autoclave, a standard cycle of: ● 20 minutes at 121°C (250°F) and 1 bar (14.5 psi). Steam Autoclaving 134°C - 137°C (273°F - 279°F) If indicated in the table, then steam autoclaving may be used as the manufacturerrecommended re-sterilization method for the part. The sterilization cycle validated by the manufacturer is, for the autoclave, a standard cycle of: ● 3 minutes at 134°C (273°F) and 2 bar (29 psi).
NOTE In France, the cycle is 18 minutes at 134°C - 137°C and 2 bar (29 psi). 12
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