Cleaning, Disinfection and Sterilization Guide

TABLE OF CONTENTS

TABLE OF CONTENTS GENERAL INFORMATION ...7 Contact Data and Legal Information ...7 Contact Data ...7 Legal Information ...8

Symbols ...9 Symbols Used in This Guide ...9 Hardware Symbols...10

Hardware ...13 Using the Hardware ...13

Documentation ...14 User Guides ...14

REPROCESSING ...15 Initial Use and Re-Use of Instruments ...15 Fundamental Notes...15

Cleaning and Disinfection ...17 Basics ...17 Pretreatment ...18 Automatic Cleaning and Disinfection...19 Manual Cleaning and Disinfection ...21 Usability Check ...23

Sterilization...24 Basics ...24 Prior to Sterilization ...25 Steam Sterilization ...26 Low Temperature Plasma Sterilization (LTP Sterilization)...28 Sterilization Trays for Steam Sterilization ...29 Sterilization Trays for LTP and Steam Sterilization ...32

Reusability ...35 Instrument Stability...35

BRAINLAB IGS INSTRUMENTATION ...37 General Instrumentation ...37 Instrument Calibration Matrix, Rev. 4 (ICM4) (41874)...37 Instrument Adapter Kits (55050, 55060, 55065) ...38 Instrument Adapter Offset (55013) ...39 Reference Array, X-Press (52410, 52411) ...40 Cleaning, Disinfection & Sterilization Guide Rev. 5.2

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TABLE OF CONTENTS

Bone Fixator “1-Pin”, X-Press (Size S (52421), M (52422) and L (52423))...42 “1-Pin” Wrench, X-Press (52424) ...44 Bone Fixator “2-Pin”, X-Press (52420) ...45 “2-Pin” Drill Template, X-Press (52425) ...46 Instrument Adapter - StarLock Interface (55080, 55085)...47 Drill Guide Standard...48 Drill Guide Depth Control (41839-50) ...49 Sharp Trocar for Drill Guide Tube 1.8 mm (41839-75)...51 Drill Guide Kit - Trocar and Tissue Protection Sleeve (55839-xx) ...52 Camera Handle Sleeve (18652-01)...54 Sterilization Tray for Steam Sterilization (523xx) ...55 Sterilization Tray for LTP Sterilization ...56 Brainlab Pointers...58 Multiple-Tip-Pointer and Paint Pointer Tip Set ...60

Cranial and ENT Instrumentation ...61 Reference Clamp Universal (41734) and Standard Cranial Reference Array (41725, 41728, 41735)...61 Vario Reference Arm for Mayfield Headholder (52001) ...63 VarioGuide (55950) ...65 Frameless Biopsy System (55940)...68 Skull Reference Set ...71 Screwdriver, Drill and Handle for Skull Reference Set...72 Reference Headband Star (41877) ...73 Z-touch Rev. 2 (18370-10) ...74 Z-touch Rev. 1 (41985) ...76 Softouch (18390-10A) ...77 Adapter for Rectangular Instruments (55105) ...79 Adapter for Cylindrical Instruments (55110)...80 Suction Tube - StarLink Interface (55790-xx) ...81 Microscope Adapter Sets (41767-xx) ...82 Ultrasound Adapter with Latch Lock...83 Ultrasound Adapter with Special Clamp Lock...84 Ultrasound Adapter with Ring Lock ...85 Ultrasound Adapter with Jaw Lock ...86 Ultrasound Adapter with Vise Lock...87 Ultrasound Registration Phantom (22630) ...88 IGSonic Adapter Base (41860-5D, 41860-35A)...89 IGSonic Adapter Array (22595) ...90

Fluoroscopic and Trauma/ACL Instrumentation ...91 Fluoro 3D/2D Registration Kit (55720) ...91 Fluoro Registration Kit, Rev. 2 (55705)...92 Fluoro Registration Kit, Rev. 1 (41705)...93 Reflective Disks (55775) ...94 Reflective Disks (for Fluoro Registration Kit, Rev. 1) (41775) ...95 Fluoro Registration Kit for Ziehm Vision FD Vario 3D C-arm (55730) ...96 xSpot ...97 xSpot Correction Plate and Accessories ...98 Reference Array for Trauma Implants (53500) ...99 Calibration Insert for Synthes LISS/LCP (53510) ...100 Calibration Insert for Synthes LFN 9-11 mm (53511) and 12-16 mm (53512) ...101 ACL Tibial Drill Guide (52475) and ICM4 Validation Insert (52476) ...102

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Hip Instrumentation ...103 Hip Caliper (52876) ...103 Pinless Femur Reference Array (52400) ...104 Adapter for Surgical Motor System (41840) ...105 Cup Reamer Adapter (41879-02, -03, -04)...106 Adapter for Cup Inserter (41851)...107 Femoral Broach Adapter “DePuy” (41852-01) ...108 Stem Position Verification Tool (52872, 52873) ...109 Brainlab Offset Reamer Handle (52481-xx)...110 Brainlab Offset Cup Impactor Universal (52856, 52855-xx)... 112 Brainlab Straight Cup Impactor “Universal” (52858) ...114

Knee Instrumentation...116 4 in 1 Cutting Block Template (Manufacturer Specific) ...116 5 in 1 Cutting Block Adapter “Zimmer NexGen” (41848) ...117 CAS Cutting Block Kit “Universal” (52480) ...118 Femoral and Tibial Cutting Block Adapter Kit “Universal II” (41888) ...122 Femoral and Tibial Cutting Block Adapter “Universal” (41866-77) ...123 Femoral Cutting Block Adapter “ENDOPLUS” (52463)...124 Femoral and Tibial Cutting Block Adapter “Smith & Nephew Genesis UNI” (41838)...125 Patella Tracking Array (52466)...126 Tibial Cutting Block Adapter “Biomet Oxford” (52854) ...127 Cut Verification Tool “Biomet Oxford” (52853) ...128 Tibial Cutting Block Adapter “ENDOPLUS” (41866-71) ...129 Fine-Adjustable Cutting Block - Femur Kit...130 Knee Plane Tool Kit...137 ClearLens Bone Fixator 2-Pin (53239/53240) ...138 ClearLens Pointer Handle - Knee (53237)...140 ClearLens Knee Plane Tool - Interface (53238)...141

Spinal Instrumentation ...142 Calibration Inserts 3.6 mm and 6.3 mm (53520, 53521)...142 Spine Reference X-Clamp (Size S (55751) and L (55752)) ...143 Radiolucent Spine Reference Clamp (55756) ...145 Spine Reference Kit, Anterior/Lateral/Oblique (55070-xx) ...147 Spinal IGS Instruments (55830-xx) ...149 Pedicle Access Needle (55843) ...150

EM TRACKING INSTRUMENTS ...151 Pointers ...151 EM Pointer (18099-02A, 18099-02B, 18099-02C)...151 EM Unsterile Registration Pointer (18099-23) ...153

References...155 EM Instrument Reference (18099-05) ...155 EM Patient Reference (18099-04)...157 EM Patient Reference (18099-24)...158 EM Skull Reference Set ...160

EM Sterilization Trays ...162 Sterilization Trays for Steam Sterilization (18099-07, 18099-08, 18099-08A)...162

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INTRAOPERATIVE IMAGING INSTRUMENTS ...163 Automatic Image Registration System for GE ...163 iMRI Registration Matrix for GE Head Holder (19202)...163 V-Inset for GE Head Holder (52006) ...165

iMRI Registration Matrix for Noras Head Holder (19102) ...166 Component Overview and Disassembling...166 iMRI Registration Matrix for Noras Head Holder (19102) ...168

iCT and iMRI Reference Equipment ...170 Cranial Reference Unit DrapeLink (19152)...170 Radiolucent Adapter for DORO Skull Clamp (19153-02)...171 Radiolucent Adapter for Mayfield Skull Clamp (19153-01) ...172

Scanner References ...173 Scanner Reference Hardware for NeuroLogica BodyTom (19134) ...173 Adhesive Flat Markers iCT (19141)...174 Adhesive Flat Markers for Scanners (19143, 19144)...175

INDEX ...177

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GENERAL INFORMATION

1

GENERAL INFORMATION

1.1

Contact Data and Legal Information

1.1.1

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

Email

United States, Canada, Central and South America

Tel: +1 800 597 5911 Fax: +1 708 409 1619

[email protected]

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

[email protected]

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

1.1.2

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. • Dismoclean® is a trademark of BODE Chemie GmbH. • 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/en/sustainability/

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GENERAL INFORMATION

1.2

Symbols

1.2.1

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

1.2.2

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

Hardware

1.3.1

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

1.4.1

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

2

REPROCESSING

2.1

Initial Use and Re-Use of Instruments

2.1.1

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 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. NOTE: All transparent packaging and other packaging, protective caps and foils etc. must be removed before using the products.

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.

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Initial Use and Re-Use of Instruments

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. 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 23

4.

Instrument usability check

Page 23

5.

Packaging

Page 26

6.

Steam (preferred) or LTP sterilization

Page 26

All components are delivered unsterile, unless specifically stated otherwise. Follow the reprocessing instructions prior to initial use and each subsequent 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

2.2.1

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 Dried-in residues following surgery can make cleaning difficult or ineffective and lead to corrosion. 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 it is recommend to use highly purified water (HPW).

Effective Cleaning and Disinfection Effective cleaning and disinfection is an absolute pre-condition for effective sterilization.

Do not use fixating pre-cleaning temperatures or fixating disinfecting agents.

Pay particular attention during cleaning to long narrow cannulations, threads and blind holes.

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Cleaning and Disinfection

2.2.2

Pretreatment

Procedural Note Correct pretreatment increases process efficiency, helping to reduce instrument damage and improve instrument turnaround time. It cannot replace mandatory disinfection or be omitted from the full cleaning, disinfection and sterilization procedure.

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 or other disposable devices e.g., Disposable Clip-on Remote Control.

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

2.2.3

Automatic Cleaning and Disinfection

General Information Where possible, perform automatic cleaning and disinfection in favor of manual cleaning and disinfection.

How to Clean and Disinfect Steps 1.

Unscrew and dispose of reflective marker spheres or other disposable devices e.g., Disposable Clip-on Remote Control.

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.

NOTE: Drying can be accelerated using medical grade compressed air or a clean, lint-free wipe.

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 Due to the potential danger of remnants staying present, the application of rinsing aids is not recommended.

Cleaning Devices Only use washer-disinfectors according to EN 15883.

Arrange medical devices so that cannulations do not lie horizontally and ensure that blind holes point downwards to assist drainage. All sections of each device must be accessible for ease of cleaning and penetration of cleaning agents. Ensure medical devices are arranged in such a way as to avoid causing collision or damage.

Thermo Disinfector • Ensure that the thermo disinfector has regulatory clearance in the jurisdiction in which it is being used, for example:

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Cleaning and Disinfection

- 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 (using rinse aid is not recommended).

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 neodisher MediZym neodisher MediClean forte

Manufacturer

Parameters

Disinfection

Dr. Weigert

Thermal at 90°C (194°F) for 5 According to manu- minutes. facturer’s specificaThermal at 93°C (199.4°F) for tions 10 minutes.

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.

Incompatible Solutions • Organic/inorganic, or oxidizing acids (pH < 4) • Strong alkalines (pH>12) • Aldehyde-releasing solutions • Phenol-releasing solutions • Chlorine-releasing solutions • Iodine-releasing solutions • NaOH and NaOCl-releasing solutions • Fluorine-releasing solutions To prevent damage to the devices, do not use incompatible solutions. NOTE: Consider instrument sections for specific incompatible solutions.

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REPROCESSING

2.2.4

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 Steps 1.

Unscrew and dispose of reflective marker spheres or other disposable devices e.g., Disposable Clip-on Remote Control.

2.

Fill a basin with a cleaning solution. Ensure that the cleaning detergent concentration is as according to the information provided by the detergent manufacturer. Full submersion of instruments must be possible.

3.

Transfer the instrument to the basin.

4.

Clean accessible surfaces of instruments with a soft brush.

5.

Remove the instrument from the basin no earlier than the minimum soaking time recommended by the manufacturer of the cleaning detergent.

6.

Rinse the instrument according to the information provided by the detergent manufacturer, using deionized water or HPW (fill lumen, blind holes).

7.

Dry instrument twice with filter-forced air.

How to Disinfect Steps 1.

Fill a basin with a disinfection solution. Full submersion of instruments must be possible.

2.

Transfer the instrument to the basin.

3.

Immerse instrument completely in the solution, filling all lumens and eliminating air pockets.

4.

Remove the instrument from the basin no earlier than the minimum soaking time recommended by the disinfectant manufacturer.

All sections of each device must be accessible for ease of cleaning and penetration of cleaning and disinfection agents. Ensure medical devices are arranged in such a way as to avoid causing collision or damage.

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

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