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Utrecht Interstitial Fletcher CT/MR Applicator Set Part Number 110.270
NUC-T377-01A
User Manual
777.00077MAN - 01
User Manual Table of Contents 1. 2. 3. 4. 5. 6. 7.
8. 9. 10. 11. 12. 13.
14. 15. 16.
17.
2
Important Notices ...3 Manufacturer ...4 Related Publications ...4 Intended Use...4 Contraindications ...5 Adverse Reactions ...5 Product Description...5 7.1 Product Identification and Revisions ...9 7.2 Technical Data ...10 7.3 Relevant Standards...12 7.4 Graphical Symbols for Medical Device Labeling ...13 7.5 Magnetic Resonance Imaging (MRI) ...13 Life Expectancy...14 Traceability...16 Transport and Storage Conditions ...16 Single Use and Reusable Parts ...16 Sterile and Non-sterile Delivered Parts ...16 Cleaning and Sterilization ...17 13.1 Pre-processing ...17 13.2 Cleaning and Disinfection...17 13.2.1 Brushing ...17 13.2.2 Cleaning ...17 13.2.3 Rinsing ...18 13.2.4 Drying...18 13.3 Sterilization...18 13.3.1 Materials...19 13.3.2 Product Revisions ...20 13.3.3 Recommended Sterilization Processes...20 13.3.4 Details of the processes ...21 13.4 Post-processing...22 Preparations...23 Inspection of the Parts before Use ...24 Insertion Procedures ...24 16.1 Prepare the intrauterine tube with interstitial cervical stopper ...25 16.2 Place the adjustable fixation mechanism ...28 16.3 Prepare the interstitial ovoid tubes ...30 16.4 Insert the applicator...33 16.5 Immobilize the Applicator ...36 16.6 Insert the Needles ...37 Imaging ...43 17.1 X-Ray Imaging...43 17.1.1 X-Ray Imaging of the Applicator...43 17.1.2 X-Ray Imaging of the Needles ...45 17.2 CT Imaging...46 17.2.1 CT-Imaging of the Needles ...46 17.3 MR Imaging ...47 Utrecht Interstitial Fletcher CT/MR Applicator Set
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User Manual 18. Determine the Distance to Dwell Position 1 ...49 18.1 Distance to Dwell Position 1 using X-Ray ...50 18.1.1 Ovoid Tubes and Intrauterine Tube...50 18.1.2 ProGuide Needles ...52 18.2 Distance to Dwell Position 1 using MR imaging ...58 18.2.1 Ovoid Tubes and Intrauterine Tube...58 18.2.2 ProGuide Needles ...60 19. Verify Treatment Planning...61 20. Treatment...62 20.1 Connect the Transfer Tubes...62 21. Removal Procedures...64 22. Disassembly Procedures ...64 22.1 Remove the adjustable fixation mechanism ...64 22.2 Disassemble the applicator ...66 22.3 Disassemble the needle insertion tool...66 23. Disposal Procedures ...66 24. Quality Assurance ...67 24.1 Inspection before use ...67 24.2 Regular inspection...67 24.3 Calibration of the CT- and X-Ray-Markers ...68 24.4 Check the length of the Transfer Tubes ...69 25. Parts List ...70 25.1 Main Parts ...70 25.2 Optional Parts...71 25.3 Required Accessories ...72
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.
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User Manual 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 the addresses in the afterloader manual).
3. Related Publications Title
Part #
microSelectron-V3 User Manual
190.050
microSelectron-V3 Reference Manual
190.051
microSelectron-V2 User Manual
092.515
microSelectron-HDR Classic User Manual
090.300
microSelectron-PDR Classic User Manual
090.313
Treatment Control Station & microSelectron-HDR Classic User Manual
092.510
Smit Sleeve CT/MR User Manual
090.712
ProGuide Needle Sets User Manual
090.695
X-Ray Catheter CT-MR GYN User Guide
090.715
CT Marker Sets User Guide
090.702
MR Line Markers User Manual
777.00081MAN
Transfer Tube Sets CT/MR GYN for microSelectron
090.685
Transfer Tube Sets for flexibles for microSelectron
090.687
Autoradiograph Check Device User Manual
090.600
CT/MR Applicator Clamp
090.716
4. Intended Use The intended use of the device is intracavitary brachytherapy for cancer treatment of the cervix and endometrium. Optional needles can be placed for interstitial brachytherapy.
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User Manual The device is intended to be used with the following Nucletron afterloaders:
microSelectron-HDR / PDR Digital, V3 and V2
microSelectron-HDR Classic,
microSelectron-PDR Classic.
Please refer to the applicable user manuals.
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 110.270
Utrecht Interstitial Fletcher CT/MR Applicator Set
Description The applicator uses an intrauterine tube and two ovoid tubes. An ovoid is placed on each ovoid tube. The ovoids have holes to guide needles for interstitial treatment. This gives additional treatment possibilities. The tubes and the ProGuide needles, if placed, guide the radioactive source of the afterloader to the location where treatment is to be applied. Transfer tubes are used to connect the applicator and the needles to the afterloader. With the adjustable cervical stopper, the intrauterine tube-length can exactly be fitted to the patient's anatomy. The intrauterine tube has adjustment centimeter-markings. The external diameter of the intrauterine tube is 6 mm. Optional thin intrauterine tubes with an external diameter of 4 mm are available. A special stopper and rectal retractors are available for the 4 mm intrauterine tubes.
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User Manual Optional Smit Sleeves CT/MR are available for easy cervical insertion of the applicator; see section 25. 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 optional Applicator Clamp (part number 189.931 or part number 189.932) can assist in immobilization of the applicator; see section 16.5. All materials of the Utrecht Interstitial Fletcher CT/MR Applicator Set are biocompatible. The main parts are delivered non-sterile. The optional ProGuide needles and the ovoid guiding tubes are for single use only and are delivered sterile.
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User Manual The following figures give an overview of the applicator and its parts. Utrecht Interstitial Fletcher CT/MR Applicator Set 1: 2: 3: 4: 5: 6:
Ovoid Tube 1 (Right) Ovoid Tube 2 (Left) Fixation screw to fixate tubes Interstitial Ovoid Intrauterine Tube ProGuide needle (sharp or round)
7: Guiding tube ovoids 8: Insertion tool 9: Adjustable fixation mechanism 10: Sterilization caps 11: Cervical Stopper 12: Obturator 13: Screwdriver 4
5
3 6 1
2 9
10
7
11
8
7 13
6 12
Figure 1: The Utrecht Interstitial Fletcher CT/MR Applicator Set
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User Manual ProGuide Needles and Obturator ProGuide Sharp Needle 294 mm 6F
ProGuide Round Needle 294 mm 6F
This needle is implanted in the treatment volume using the proguide obturator. ProGuide Obturator 294 mm for 6F
The obturator is inserted into a needle to support the needle during insertion and to prevent kinking or breaking of the needle. The following figure shows the obturator inserted in a sharp needle.
Figure 2: The ProGuide Needles and Obturator
Fixation Parts 14: Fixation Clip
15: Rectal Retractor
14
16: Fixation Nut 16
15
Figure 3: The fixation clip, rectal retractor and its fixation nut
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User Manual Optional Intrauterine Tube (4 mm) 1: 2: 3: 4:
Ovoid Tube Stopper Rectal Retractor with slot Adjustable fixation mechanism
5: Intrauterine Tube (4 mm) 6: Sterilization caps
1 Optional Intrauterine Tube with 4 mm outer diameter 6
5
4 2
3 Figure 4: Optional Intrauterine Tube (4 mm).
7.1
Product Identification and Revisions
On most applicator parts, the part-number is engraved, for example 189.739-06. 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 189.739 is engraved. Some very small parts do not have a part-number engraved at all. 189.739 – 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 5: Product Evolution by Revisions; example.
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User Manual 7.2
Technical Data
External diameter of the intrauterine tubes and ovoid tubes: 6 mm. Optional thin intrauterine tubes with an external diameter of 4 mm are available. The diameter is larger at the tube joints. The intrauterine tube (6 mm) is available with an angle of 15º, 30º and optionally 45º. The optional intrauterine tube (4 mm) is available with an angle of 15º, 30º, 45º. For the dimensions of the ovoid pairs, see Table 1 and Table 2. Ovoid pairs are available with radius R10 and an angle of 15º: Optional ovoid pairs with radius R10 and an angle of 25º are available. The following tables list the dimensions of the ovoid pairs. For the view directions, see Figure 6 and Figure 7. Cranial-caudal view direction
Right-lateral view direction Left-lateral view direction Ventral-dorsal view direction
Figure 6: Ovoid caps: view directions
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User Manual X mm
R mm
E mm
F mm
Y mm
Height mm
110.240
15
10
0
10
17.5
30
Interstitial ovoid pair 20 mm (R10)
110.241
20
10
0
10
20
30
Interstitial ovoid pair 25 mm (R10)
110.242
25
10
2.5
10
22.5
30
Interstitial ovoid pair 30 mm (R10)
110.243
30
10
5
10
25
30
Type
Part no.
Interstitial ovoid pair 15 mm (R10)
Picture
Table 1: Dimensions of the Interstitial Ovoids
Cranial-caudal view direction
Left-lateral view direction
Right-lateral view direction
Ventral-dorsal view direction Figure 7: Ovoid caps: view directions and dimensions (mm)
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User Manual Overview of needle positions in the ovoids
Figure 8: Overview of needle positions in the ovoids
Part no.
Interstitial ovoid pair type:
A mm
B mm
C mm
D mm
E mm
F mm
G mm
H mm
I º
110.240 110.241 110.242 110.243 110.252 110.253 110.254 110.255
15 mm (R10) 15º 20 mm (R10) 15º 25 mm (R10) 15º 30 mm (R10) 15º 15 mm (R10) 25º (optional) 20 mm (R10) 25º (optional) 25 mm (R10) 25º (optional) 30 mm (R10) 25º (optional)
27.4 32.4 37.4 42.4 27.4 32.4 37.4 42.4
6.2 6.2 6.2 6.2 6.2 6.2 6.2 6.2
n/a 12.4 12.4 13.4 n/a 12.4 12.4 13.4
n/a 7.6 12.6 15.6 n/a 7.6 12.6 15.6
n/a 15 15 15 n/a 16 15 15
7 7 7 7 7 7 7 7
7 7 7 7 7 7 7 7
n/a 8 8 8 n/a 8 8 8
15 15 15 15 25 25 25 25
Table 2: Internal measurements of needle positions in the Ovoids n/a = not applicable
7.3
Relevant Standards
MDD classification: Accessory to a Class IIb device. FDA classification: Accessory to a Class II device. IEC 60601-1, type BF (subclause 5.2): Protection against electric shock.
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User Manual 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)
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
Utrecht Interstitial Fletcher CT/MR Applicator Set
MR Safe
MR Safe All parts of the Utrecht Interstitial Fletcher CT/MR Applicator Set that are intended to be inserted into the patient are MR safe. The titanium screwdriver and obturators are not suited to be used in the MRI device during imaging. These parts can be used in the vicinity of the MRI device. 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,
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User Manual
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.
8. Life Expectancy Main parts: Part no.
Description
Life Expectancy
110.270
Utrecht Interstitial Fletcher CT MR Applicator Set
Typical expected reuse life of 3 years. Delivered non-sterile.
Optional parts: Part no.
Description
Life Expectancy
110.271
Utrecht Interstitial Fletcher CT MR Complementary Set
Typical expected reuse life of 3 years. Delivered non-sterile.
189.769
Intrauterine Tube (6 mm), 45º
Typical expected reuse life of 3 years. Delivered non-sterile.
110.296 110.298
Intrauterine Tube (4 mm), 15º, 30º and Typical expected reuse life of 45º 3 years. Delivered non-sterile.
110.300 110.272
Interstitial Ovoid Set 25º
Typical expected reuse life of 3 years. Delivered non-sterile.
101.031
Fixation Mechanism for Ovoid Tubes
Typical expected reuse life of 3 years. Delivered non-sterile.
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User Manual Part no.
Description
Life Expectancy
101.015
Sterilization Box
Typical expected reuse life of 3 years. Delivered non-sterile.
189.566
Smit Sleeves CT/MR
Single Use.
For use with Intrauterine Tubes (6 mm) Delivered sterile. 189.676 189.677 189.679 189.681 189.682 189.683
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)
Required accessories: Part no.
Description
Life Expectancy
110.230
ProGuide Needle Round 6F x 294mm (set of 5)
Single Use.
ProGuide Needle Sharp 6F x 294mm (set of 5)
Single Use.
Guiding Tube Ovoids (set of 5)
Single Use.
X-ray Catheter Set (50 cm)
Typical expected reuse life of 3 years
110.231 110.232 089.089 089.090
Delivered sterile. Delivered sterile. Delivered sterile.
Delivered non-sterile 110.287 189.693 189.039
CT Markers
These parts have their own user manual
101.065
X-ray Catheter Set CT/MR GYN
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
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User Manual 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.
10. 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:
0C - 50C (32F - 122F)
Humidity:
Non-condensing
Pressure Range:
Atmospheric pressure with normal variations
11. 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 7.5). 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.
12. 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.
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. 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.
NOTE The applicator set is delivered with spare nuts for the adjustable fixation mechanism. It is recommended to have at least one spare sterile nut available during treatment. If a nut becomes non-sterile, then a spare sterile nut can be used.
13.2
Cleaning and Disinfection
13.2.1 Brushing If necessary, clean the outside of the parts 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). 13.2.2 Cleaning Clean the parts in an automatic washer/disinfector or an ultrasonic cleaning device. In these devices, 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
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User Manual 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.
13.3
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. 18
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User Manual 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 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 The Utrecht Interstitial Fletcher 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
Interstitial Ovoid caps
PPSU
Cervical Stopper
PPSU
Adjustable Fixation Mechanism
PPSU / Titanium
Clip
PPSU
Rectal Retractors
PPSU
Screwdriver for Ovoids and Stopper Insertion Tool
Titanium
Obturators
Nitinol (Nickel – Titanium)
PPSU
For the relation between part-descriptions and part-numbers see the parts list in section 25).
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 189.739-06. 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 '189.739' is engraved. Some very small parts do not have a part-number engraved at all. 189.739 - 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
Intrauterine Tubes
Revision 03 or higher
Revision 06 or higher
All revisions
Ovoid Tubes
Revision 03 or higher
Revision 06 or higher
All revisions
Interstitial Ovoid caps
Revision 03 or higher
Revision 03 or higher
X
Cervical Stopper
Revision 03 or higher
Revision 03 or higher
All revisions
Adjustable Fixation Mechanism
Revision 03 or higher
Revision 03 or higher
All revisions
Clip
Revision 03 or higher
Revision 03 or higher
All revisions
Rectal Retractors
Revision 03 or higher
Revision 03 or higher
All revisions
Screwdriver for Ovoids and Stopper
All revisions
All revisions
All revisions
Insertion Tool
All revisions
All revisions
X
Obturators
All revisions
All revisions
X
X = Not valid
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