BRAINLAB
CLEANING and STERILIZATION GUIDE Rev 5.1
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CLEANING, DISINFECTION AND STERILIZATION GUIDE
Revision 5.1 Copyright 2015, Brainlab AG Germany. All rights reserved.
TABLE OF CONTENTS
TABLE OF CONTENTS GENERAL INFORMATION ...7 Contact Data and Legal Information ...7 Legal Information ...8
Symbols ...9 Hardware Symbols...10
Indications for Use...13 Documentation ...14
REPROCESSING ...15 Initial Use and Re-Use of Instruments ...15 Cleaning and Disinfection ...17 Pretreatment ...18 Automatic Cleaning and Disinfection...19 Manual Cleaning and Disinfection ...21 Usability Check ...22
Sterilization...23 Prior to Sterilization ...24 Steam Sterilization ...25 Low Temperature Plasma Sterilization (LTP Sterilization)...27 Sterilization Trays for Steam Sterilization ...28 Sterilization Trays for LTP and Steam Sterilization ...31
Reusability ...34
BRAINLAB IGS INSTRUMENTATION ...35 General Instrumentation ...35 Instrument Adapter Kits (55050, 55060, 55065) ...36 Instrument Adapter Offset (55013) ...37 Reference Array, X-Press (52410, 52411) ...38 Bone Fixator “1-Pin”, X-Press (Size S (52421), M (52422) and L (52423))...40 “1-Pin” Wrench, X-Press (52424) ...42 Bone Fixator “2-Pin”, X-Press (52420) ...43 “2-Pin” Drill Template, X-Press (52425) ...44 Instrument Adapter - StarLock Interface (55080, 55085)...45 Drill Guide Standard...46 Drill Guide Depth Control (41839-50) ...47 Sharp Trocar for Drill Guide Tube 1.8 mm (41839-75)...49 Drill Guide Kit - Trocar and Tissue Protection Sleeve (55839-xx) ...50 Cleaning, Disinfection & Sterilization Guide Rev. 5.1
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TABLE OF CONTENTS
Camera Handle Sleeve (18652-01)...52 Sterilization Tray for Steam Sterilization (523xx) ...53 Sterilization Tray for LTP Sterilization ...54 Brainlab Pointers...56 Multiple-Tip-Pointer and Paint Pointer Tip Set ...58
Cranial and ENT Instrumentation ...59 Vario Reference Arm for Mayfield Headholder (52001) ...61 VarioGuide (55950) ...63 Frameless Biopsy System (55940)...66 Skull Reference Set ...69 Screwdriver, Drill and Handle for Skull Reference Set...70 Reference Headband Star (41877) ...71 Z-touch Rev. 2 (18370-10) ...72 Z-touch Rev. 1 (41985) ...74 Softouch (18390-10A) ...75 Adapter for Rectangular Instruments (55005) ...77 Adapter for Cylindrical Instruments (55010) ...78 Suction Tube - StarLink Interface (55790-xx) ...79 Microscope Adapter Sets (41767-xx) ...80 Ultrasound Adapter with Latch Lock...81 Ultrasound Adapter with Special Clamp Lock...82 Ultrasound Adapter with Ring Lock ...83 Ultrasound Adapter with Jaw Lock ...84 Ultrasound Adapter with Vise Lock...85 Ultrasound Registration Phantom (22630) ...86 IGSonic Adapter Base (41860-5D, 41860-35A)...87 IGSonic Adapter Array (22595) ...88
Fluoroscopic and Trauma/ACL Instrumentation ...89 Fluoro Registration Kit, Rev. 2 (55705)...90 Fluoro Registration Kit, Rev. 1 (41705)...91 Reflective Disks (55775) ...92 Reflective Disks (for Fluoro Registration Kit, Rev. 1) (41775) ...93 Fluoro Registration Kit for Ziehm Vision FD Vario 3D C-arm (55730) ...94 xSpot ...95 xSpot Correction Plate and Accessories ...96 Reference Array for Trauma Implants (53500) ...97 Calibration Insert for Synthes LISS/LCP (53510) ...98 Calibration Insert for Synthes LFN 9-11 mm (53511) and 12-16 mm (53512) ...99 ACL Tibial Drill Guide (52475) and ICM4 Validation Insert (52476) ...100
Hip Instrumentation ...101 Pinless Femur Reference Array (52400) ...102 Adapter for Surgical Motor System (41840) ...103 Cup Reamer Adapter (41879-02, -03, -04)...104 Adapter for Cup Inserter (41851)...105 Femoral Broach Adapter “DePuy” (41852-01) ...106 Stem Position Verification Tool (52872, 52873) ...107 Brainlab Offset Reamer Handle (52481-xx)...108 Brainlab Offset Cup Impactor Universal (52856, 52855-xx)...110 Brainlab Straight Cup Impactor “Universal” (52858) ...112
Knee Instrumentation...114 4
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5 in 1 Cutting Block Adapter “Zimmer NexGen” (41848) ...115 CAS Cutting Block Kit “Universal” (52480) ...116 Femoral and Tibial Cutting Block Adapter Kit “Universal II” (41888) ...120 Femoral and Tibial Cutting Block Adapter “Universal” (41866-77) ...121 Femoral Cutting Block Adapter “ENDOPLUS” (52463)...122 Femoral and Tibial Cutting Block Adapter “Smith & Nephew Genesis UNI” (41838)...123 Patella Tracking Array (52466)...124 Tibial Cutting Block Adapter “Biomet Oxford” (52854) ...125 Cut Verification Tool “Biomet Oxford” (52853) ...126 Tibial Cutting Block Adapter “ENDOPLUS” (41866-71) ...127 Fine-Adjustable Cutting Block - Femur Kit...128
Spinal Instrumentation ...135 Spine Reference X-Clamp (Size S (55751) and L (55752)) ...136 Radiolucent Spine Reference Clamp (55756) ...137 Spine Reference Kit, Anterior/Lateral/Oblique (55070-xx) ...139 Spinal IGS Instruments (55830-xx) ...141 Pedicle Access Needle (55843) ...142
EM TRACKING INSTRUMENTS ...145 Pointers ...145 EM Softouch (18099-03) ...148
References...150 EM Patient Reference (18099-04)...151
INTRAOPERATIVE IMAGING INSTRUMENTS ...153 Automatic Image Registration System for GE ...153 Reference Unit DrapeLink for iMRI...155 V-Inset for GE Head Holder (52006) ...157
BrainSUITE iMRI Reference Package - Noras Headholder and Coil (19101)...158 iMRI Registration Matrix for Noras Head Holder (19102) ...160 iMRI Reference Array 19103...162
iCT Reference Equipment ...163 Reference Array iOP Imaging Kit (19145-01, -02) and Reference Array iOP Imaging Kit - Short (19130-01, -02) ...165 Headholder Adapter iOP Imaging DO/MF (19146-01) ...166 Radiolucent Adapter for DORO Skull Clamp (19147-06, 19153-02) ...168 Radiolucent Adapter for Mayfield Skull Clamp (19147-07, 19153-01) ...170 Headholder Adapter iOP Imaging - GE Healthcare (19131-02) ...172
Scanner References ...173 Adhesive Flat Markers iCT (19141)...174 Adhesive Flat Markers for Scanners (19143, 19144)...175
INDEX ...177
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TABLE OF CONTENTS
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GENERAL INFORMATION
1
GENERAL INFORMATION
1.1
Contact Data and Legal Information
Contact Data
Support If you cannot find information you need in this guide, or if you have questions or problems, contact Brainlab support: Region
Telephone and Fax
United States, Canada, Central and South America
Tel: (800) 597-5911 Fax: (708) 409-1619
Brazil
Tel: (0800) 892-1217
UK
Tel: +44 1223 755 333
Spain
Tel: +34 (900) 649 115
France and French-speaking regions
Tel: +33 800 676 030
Africa, Asia, Australia, Europe
Tel: +49 89 991568-44 Fax: +49 89 991568-811
Japan
Tel: +81 3 3769 6900 Fax: +81 3 3769 6901
Expected Service Life Unless specifically stated otherwise, there is no defined service life for instruments. The end of service life depends on wear and damage during use. Repeated reprocessing has minimal effect on the service life time.
Feedback Despite careful review, this manual may contain errors. Please contact us at [email protected] if you have suggestions as to how we can improve this manual.
Manufacturer Brainlab AG Kapellenstr. 12 85622 Feldkirchen Germany
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Contact Data and Legal Information
1.1.1
Legal Information
Copyright This guide contains proprietary information protected by copyright. No part of this guide may be reproduced or translated without express written permission of Brainlab.
Brainlab Trademarks • Softouch® is a registered trademark of Brainlab in Germany and/or the US. • StarLink® is a registered trademark of Brainlab in Germany and/or the US. • Z-touch® is a registered trademark of Brainlab in Germany and/or the US.
Non-Brainlab Trademarks • BodyTom® is a registered trademark of NeuroLogica Corporation. • DORO® is a registered trademark of pro med instruments GmbH in Germany, the US and/or other countries. • Mayfield® is a registered trademark of OMI, Inc. • neodisher® is a trademark of Chemische Fabrik Dr. Weigert GmbH & Co. KG. • CIDEX®, CIDEZYME® and STERRAD® and are trademarks of Advanced Sterilization Products (ASP), a Division of Medos International Sàrl.
CE Label • The CE label shows that the Brainlab product complies with the essential requirements of Medical Device Directive (MDD). • According to MDD, Council Device Directive 93/42/EEC, classification of the Brainlab product is defined in the corresponding Software User Guide. NOTE: The validity of the CE label can only be confirmed for products manufactured by Brainlab.
Disposal Instructions When a surgical instrument reaches the end of its functional life, clean the instrument of all biomaterial/biohazards and safely dispose of the instrument in accordance with applicable laws and regulations. Only dispose of electrical and electronic equipment in accordance with statutory regulations. For information regarding the WEEE (Waste Electrical and Electronic Equipment) directive, visit: http://www.brainlab.com/weee
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GENERAL INFORMATION
1.2
Symbols
Symbols Used in This Guide
Warnings Warnings are indicated by triangular warning symbols. They contain safety-critical information regarding possible injury, death or other serious consequences associated with equipment misuse.
Cautions Cautions are indicated by circular caution symbols. They contain safety-critical information regarding possible problems with the device. Such problems include device malfunctions, device failure, damage to device or damage to property.
Notes NOTE: Notes are formatted in italic type and indicate additional useful hints.
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Symbols
1.2.1
Hardware Symbols
Symbols and Abbreviations on Hardware Components Symbol
Explanation Type B Applied Part according to IEC 60601-1
Type BF Applied Part according to IEC 60601-1
Caution
Warning, laser radiation
Potential equalization point
MR Safe
MR Unsafe
MR Conditional: The number shown on each label specifies the MR environment in which the device can be used with caution
Do not reuse
Non-Sterile
Do not resterilize
Sterilized with ethylene oxide
Product manufactured with components that do not contain natural rubber latex
Fragile, handle with care
Do not use if packaging is damaged
Keep away from sunlight
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GENERAL INFORMATION
Symbol
Explanation Keep dry
Storage conditions for temperature: The specified temperature range is shown on each label.
Storage conditions for relative humidity non-condensing: The specified humidity range is shown on each label.
Storage conditions for air pressure: The specified air pressure range is shown on each label.
Quantity of products in packaging
Batch number
Serial number
Article number
Use by month YYYY
Date of manufacture
Manufacturer
Authorized representative in the European Community
IPXY
Ingress Protection according to IEC 60529 • X = Protection against ingress of solid objects • Y = Protection against ingress of liquid On/off switch
Standby switch to bring the device into standby mode
Acoustic power output of integrated ultrasound probes complies with FDA Track 3 and IEC 60601-2-37
Consult the operating instructions
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Symbols
Symbol
Explanation Follow the instructions for use
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GENERAL INFORMATION
1.3
Indications for Use
Using the Hardware
Careful Hardware Handling Only trained medical personnel may operate system components and accessory instrumentation. As Brainlab navigation instruments are precalibrated, handle all parts with extreme care.
System components and accessory instrumentation comprise precise mechanical parts. Handle them carefully.
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Documentation
1.4
Documentation
User Guides
Reading User Guides The user guides describe complex medical devices and surgical navigation software that must be used with care. It is important that all users of system, instruments and software: • Read the user guides carefully before handling the equipment • Have access to the user guides at all times
Available User Guides
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User Guide
Contents
Software User Guides
• Overview of treatment planning and image-guided navigation • Description of OR system setup • Detailed software instructions
Instrument User Guides
Detailed instructions on instrument handling
Cleaning, Disinfection and Sterilization Guide
Details on cleaning, disinfecting and sterilizing instruments
System User Guides
Comprehensive information on system setup
Technical User Guide
Detailed technical information on the system, including specifications and compliances
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REPROCESSING
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REPROCESSING
2.1
Initial Use and Re-Use of Instruments
Fundamental Notes
Responsibility • Use only approved devices (washer-disinfector, sterilizer) and validated product-specific procedures • Apply the validated parameters in each re-use cycle • Pay close attention to your hospital’s hygiene guidelines as well The reprocessing personnel are responsible for ensuring that reprocessing achieves the desired result. This normally requires validation and routine monitoring of process, equipment and materials. Any deviation by the reprocessing personnel from the instructions should be evaluated for effectiveness and potential adverse effects. If processes are altered, the desired effect may not be achieved. Brainlab excludes any liability in this case. Only use reprocessing procedures described in this guide. Other procedures could result in material damage, corrosion, fatigue, breakage, or decrease the weight bearing capability of the instrument.
Disassembling Instruments Disassemble/reassemble/unscrew instruments as described in the corresponding sections.
Disposables
Figure 1 Disposable products are for single-use only. Do not attempt to reprocess any disposables.
Disposable Reflective Marker Spheres Reflective marker spheres are for single-use only. Do not re-sterilize them, as sterilization may lead to reduced accuracy and endanger patient safety.
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Initial Use and Re-Use of Instruments
Unscrew reflective marker spheres from all instrument components and dispose of them prior to component reprocessing.
Reprocessing Instruments Effective cleaning and disinfection is essential for effective instrumentation sterilization. Follow the instructions for each individual instrument, as each instrument may be processed differently. Ensure that all components (threads, guidances, etc.) are thoroughly cleaned, disinfected and sterilized, according to the following table and its respective instrument section: Step
Procedure
See
1.
Pretreatment
Page 18
2.
Automated or manual cleaning and disinfection
Page 19
3.
Post-drying
Page 22
4.
Instrument usability check
Page 22
5.
Packaging
Page 25
6.
Steam (preferred) or LTP sterilization
Page 25
All components are delivered unsterile, unless specifically stated otherwise. Follow the reprocessing instructions prior to use.
Neutralization If instrument neutralization is required, use phosphoric solution, citric solutions or sodium hypochlorite solutions (2%) as described by the solution manufacturer. Alkaline solutions lead to severe corrosion of aluminium instruments.
Creutzfeldt-Jakob Contamination Do not use Brainlab instrumentation on patients suspected of having Creutzfeldt-Jakob disease (CJD or vCJD).
Contact with the Central Nervous System Standard reprocessing methods are not fully effective for endotoxic contaminated instruments. Endotoxic contamination can only be removed using aggressive treatments, e.g., very high temperatures. Such parameters have not been validated for Brainlab instruments.
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REPROCESSING
2.2
Cleaning and Disinfection
Basics
Authorization Cleaning and disinfection of Brainlab components may only be performed by trained reprocessing personnel. Do not clean or disinfect instruments within the Sterilization Tray, as this may result in insufficient cleaning or disinfection.
When to Clean and Disinfect Perform cleaning and disinfection directly (no later than 2 hours) after use.
Applicability Not all procedures can be applied to all instruments. This is noted in the descriptions of the individual instruments.
Recommended Water In accordance with ISO standard 17664 and European Pharmacopeia (PharmEur) and US Pharmacopeia (USP) directives, deionized water is recommended for final rinse and was used for Brainlab instrument validation. In order to avoid re-contamination of instruments we recommend using HPW (highly purified water).
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Cleaning and Disinfection
2.2.1
Pretreatment
Cleaning Detergent Cleaning detergent requirements: • Approved for instrument cleaning • Aldehyde-free (otherwise fixation of blood impurities occurs) • Officially approved regarding efficiency, for example: - FDA clearance - CE marking - Listed by DGHM/VAH/ÖGHMP • Compatible with instruments to be cleaned
How to Pretreat Steps 1.
Unscrew and dispose of reflective marker spheres.
2.
Remove coarse impurities from instruments directly after use (within a maximum of 2 hours) using running water (20-30°C) or a cleaning-disinfectant solution.
3.
Using a brush, apply detergent solution to all surfaces, threads, cannulations and holes, ensuring that all parts are cleaned. • To manually remove impurities, use only a soft brush or a clean soft tissue • Do not use metal brushes or steel wool
4.
Ultrasonic cleaning may be used to enhance initial cleaning. Make sure that: • The ultrasound bath is large enough for complete immersion of instruments • Instruments do not collide • Blind holes are filled
5.
Rinse under clean running water for at least 3 minutes, ensuring that: • Running water passes through cannulations • Blind holes are repeatedly filled and emptied
6.
Check all parts and holes for contamination residue. If residue is still visible, repeat steps.
Full Cleaning and Disinfection Perform additional full cleaning and disinfection subsequently.
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REPROCESSING
2.2.2
Automatic Cleaning and Disinfection
How to Clean and Disinfect Steps 1.
Unscrew and dispose of reflective marker spheres.
2.
Transfer instruments to washer-disinfector. Use baskets for small instruments.
3.
Start program.
4.
After program has finished, let instruments dry and then remove them.
Cleaning Detergent Requirements for cleaning detergent: • Approved for instrument cleaning • Used at the concentration recommended by manufacturer • Officially approved regarding efficiency, for example: - FDA clearance - CE marking - Listed by DGHM/VAH/ÖGHMP • Compatible with instruments to be cleaned
Cleaning Devices Only use washer-disinfectors according to EN 15883.
Thermo Disinfector • Ensure that the thermo disinfector has regulatory clearance in the jurisdiction in which it is being used, for example: - FDA clearance - CE marking - Listed by DGHM/ÖGHMP • Use only a cleaning and disinfection program with sufficient rinsing and drying steps and filtered air • Use deionized water or HPW for post-rinsing
Validation Parameters The fundamental suitability of instruments for effective automatic cleaning and disinfection was validated by an independent test laboratory in accordance with following parameters:
Cleaning Detergents
Type
Parameters
Manufacturer
Concentration
neodisher medizym neodisher MediClean forte
10 min at 93°C (199.4°F)
Dr. Weigert
According to manufacturer’s specifications
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Cleaning and Disinfection
Other Procedures If procedures other than those described above are used (for example: chemical disinfectant), the fundamental suitability and efficiency must be validated. Chemical disinfectants may lead to corrosion and abrasion of aluminum anodized instruments. To extend component’s service life, use enzymatic cleaning solvents.
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REPROCESSING
2.2.3
Manual Cleaning and Disinfection
Validation Manual cleaning and disinfection procedures have only been validated for instruments where automatic methods do not apply. This is explicitly stated in the descriptions of the individual instruments.
How to Clean and Disinfect Steps 1.
Unscrew and dispose of reflective marker spheres.
2.
Fill a basin with cleaning and disinfection solution. Full submersion of instruments must be possible.
3.
Transfer instruments to basin.
4.
Clean outer surfaces of instruments with a soft brush.
5.
Remove instruments from basin no earlier than the minimum soaking time recommended by the manufacturer of cleaning detergent and disinfectant.
6.
Rinse instruments according to the information provided by the detergent manufacturer, using deionized water or HPW (fill lumen, blind holes).
7.
Dry instruments twice with filter-forced air.
Cleaning Detergent Requirements for cleaning and disinfection detergent: • Officially approved regarding efficiency, for example: - FDA clearance - CE marking - Listed by DGHM/VAH/ÖGHMP • Compatible with instruments to be cleaned • Used at the concentration and soaking time recommended by manufacturer NOTE: Only use freshly-prepared solutions. Prevent detergent solutions from foaming.
Validated Detergents The fundamental suitability of instruments for effective manual cleaning and disinfection was validated by an independent test laboratory using the following detergents: Manual cleaning
Manual disinfection
Detergent
CIDEZYME® ENZOL
CIDEX® OPA
Manufacturer
Johnson & Johnson
Parameters
See manufacturer’s instructions.
Other Procedures If procedures other than those described are used, the fundamental efficiency must be validated.
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