GUIDE STERILIZATION AND DISINFECTION CLEANING,
CLEANING,DISINFECTIONANDSTERILIZATIONGUIDERevision 5.2Copyright 2016, Brainlab AG Germany. All rights reserved.
TABLE OF CONTENTSTABLE OF CONTENTSGENERAL INFORMATION .7Contact Data and Legal Information .7Contact Data .7Legal Information .8Symbols .9Symbols Used in This Guide .9Hardware Symbols.10Hardware .13Using the Hardware .13Documentation .14User Guides .14REPROCESSING .15Initial Use and Re-Use of Instruments .15Fundamental Notes.15Cleaning and Disinfection .17Basics .17Pretreatment .18Automatic Cleaning and Disinfection.19Manual Cleaning and Disinfection .21Usability Check .23Sterilization.24Basics .24Prior to Sterilization .25Steam Sterilization .26Low Temperature Plasma Sterilization (LTP Sterilization).28Sterilization Trays for Steam Sterilization .29Sterilization Trays for LTP and Steam Sterilization .32Reusability .35Instrument Stability.35BRAINLAB IGS INSTRUMENTATION .37General Instrumentation .37Instrument Calibration Matrix, Rev. 4 (ICM4) (41874).37Instrument Adapter Kits (55050, 55060, 55065) .38Instrument Adapter Offset (55013) .39Reference Array, X-Press (52410, 52411) .40Cleaning, Disinfection & Sterilization Guide Rev. 5.23
TABLE OF CONTENTSBone Fixator “1-Pin”, X-Press (Size S (52421), M (52422) and L (52423)).42“1-Pin” Wrench, X-Press (52424) .44Bone Fixator “2-Pin”, X-Press (52420) .45“2-Pin” Drill Template, X-Press (52425) .46Instrument Adapter - StarLock Interface (55080, 55085).47Drill Guide Standard.48Drill Guide Depth Control (41839-50) .49Sharp Trocar for Drill Guide Tube 1.8 mm (41839-75).51Drill Guide Kit - Trocar and Tissue Protection Sleeve (55839-xx) .52Camera Handle Sleeve (18652-01).54Sterilization Tray for Steam Sterilization (523xx) .55Sterilization Tray for LTP Sterilization .56Brainlab Pointers.58Multiple-Tip-Pointer and Paint Pointer Tip Set .60Cranial and ENT Instrumentation .61Reference Clamp Universal (41734) and Standard Cranial Reference Array (41725, 41728, 41735).61Vario Reference Arm for Mayfield Headholder (52001) .63VarioGuide (55950) .65Frameless Biopsy System (55940).68Skull Reference Set .71Screwdriver, Drill and Handle for Skull Reference Set.72Reference Headband Star (41877) .73Z-touch Rev. 2 (18370-10) .74Z-touch Rev. 1 (41985) .76Softouch (18390-10A) .77Adapter for Rectangular Instruments (55105) .79Adapter for Cylindrical Instruments (55110).80Suction Tube - StarLink Interface (55790-xx) .81Microscope Adapter Sets (41767-xx) .82Ultrasound Adapter with Latch Lock.83Ultrasound Adapter with Special Clamp Lock.84Ultrasound Adapter with Ring Lock .85Ultrasound Adapter with Jaw Lock .86Ultrasound Adapter with Vise Lock.87Ultrasound Registration Phantom (22630) .88IGSonic Adapter Base (41860-5D, 41860-35A).89IGSonic Adapter Array (22595) .90Fluoroscopic and Trauma/ACL Instrumentation .91Fluoro 3D/2D Registration Kit (55720) .91Fluoro Registration Kit, Rev. 2 (55705).92Fluoro Registration Kit, Rev. 1 (41705).93Reflective Disks (55775) .94Reflective Disks (for Fluoro Registration Kit, Rev. 1) (41775) .95Fluoro Registration Kit for Ziehm Vision FD Vario 3D C-arm (55730) .96xSpot .97xSpot Correction Plate and Accessories .98Reference Array for Trauma Implants (53500) .99Calibration Insert for Synthes LISS/LCP (53510) .100Calibration Insert for Synthes LFN 9-11 mm (53511) and 12-16 mm (53512) .101ACL Tibial Drill Guide (52475) and ICM4 Validation Insert (52476) .1024Cleaning, Disinfection & Sterilization Guide Rev. 5.2
TABLE OF CONTENTSHip Instrumentation .103Hip Caliper (52876) .103Pinless Femur Reference Array (52400) .104Adapter for Surgical Motor System (41840) .105Cup Reamer Adapter (41879-02, -03, -04).106Adapter for Cup Inserter (41851).107Femoral Broach Adapter “DePuy” (41852-01) .108Stem Position Verification Tool (52872, 52873) .109Brainlab Offset Reamer Handle (52481-xx).110Brainlab Offset Cup Impactor Universal (52856, 52855-xx). 112Brainlab Straight Cup Impactor “Universal” (52858) .114Knee Instrumentation.1164 in 1 Cutting Block Template (Manufacturer Specific) .1165 in 1 Cutting Block Adapter “Zimmer NexGen” (41848) .117CAS Cutting Block Kit “Universal” (52480) .118Femoral and Tibial Cutting Block Adapter Kit “Universal II” (41888) .122Femoral and Tibial Cutting Block Adapter “Universal” (41866-77) .123Femoral Cutting Block Adapter “ENDOPLUS” (52463).124Femoral and Tibial Cutting Block Adapter “Smith & Nephew Genesis UNI” (41838).125Patella Tracking Array (52466).126Tibial Cutting Block Adapter “Biomet Oxford” (52854) .127Cut Verification Tool “Biomet Oxford” (52853) .128Tibial Cutting Block Adapter “ENDOPLUS” (41866-71) .129Fine-Adjustable Cutting Block - Femur Kit.130Knee Plane Tool Kit.137ClearLens Bone Fixator 2-Pin (53239/53240) .138ClearLens Pointer Handle - Knee (53237).140ClearLens Knee Plane Tool - Interface (53238).141Spinal Instrumentation .142Calibration Inserts 3.6 mm and 6.3 mm (53520, 53521).142Spine Reference X-Clamp (Size S (55751) and L (55752)) .143Radiolucent Spine Reference Clamp (55756) .145Spine Reference Kit, Anterior/Lateral/Oblique (55070-xx) .147Spinal IGS Instruments (55830-xx) .149Pedicle Access Needle (55843) .150EM TRACKING INSTRUMENTS .151Pointers .151EM Pointer (18099-02A, 18099-02B, 18099-02C).151EM Unsterile Registration Pointer (18099-23) .153References.155EM Instrument Reference (18099-05) .155EM Patient Reference (18099-04).157EM Patient Reference (18099-24).158EM Skull Reference Set .160EM Sterilization Trays .162Sterilization Trays for Steam Sterilization (18099-07, 18099-08, 18099-08A).162Cleaning, Disinfection & Sterilization Guide Rev. 5.25
TABLE OF CONTENTSINTRAOPERATIVE IMAGING INSTRUMENTS .163Automatic Image Registration System for GE .163iMRI Registration Matrix for GE Head Holder (19202).163V-Inset for GE Head Holder (52006) .165iMRI Registration Matrix for Noras Head Holder (19102) .166Component Overview and Disassembling.166iMRI Registration Matrix for Noras Head Holder (19102) .168iCT and iMRI Reference Equipment .170Cranial Reference Unit DrapeLink (19152).170Radiolucent Adapter for DORO Skull Clamp (19153-02).171Radiolucent Adapter for Mayfield Skull Clamp (19153-01) .172Scanner References .173Scanner Reference Hardware for NeuroLogica BodyTom (19134) .173Adhesive Flat Markers iCT (19141).174Adhesive Flat Markers for Scanners (19143, 19144).175INDEX .1776Cleaning, Disinfection & Sterilization Guide Rev. 5.2
GENERAL INFORMATION1GENERAL INFORMATION1.1Contact Data and Legal Information1.1.1Contact DataSupportIf you cannot find information you need in this guide, or if you have questions or problems, contactBrainlab support:RegionTelephone and FaxEmailUnited States, Canada, Central andSouth AmericaTel: 1 800 597 5911Fax: 1 708 409 1619us.support@brainlab.comBrazilTel: (0800) 892 1217UKTel: 44 1223 755 333SpainTel: 34 900 649 115France and French-speaking regionsTel: 33 800 676 030Africa, Asia, Australia, EuropeTel: 49 89 991568 44Fax: 49 89 991568 811JapanTel: 81 3 3769 6900Fax: 81 3 3769 6901support@brainlab.comExpected Service LifeUnless specifically stated otherwise, there is no defined service life for instruments. The end ofservice life depends on wear and damage during use. Repeated reprocessing has minimal effecton the service life time.FeedbackDespite careful review, this manual may contain errors.Please contact us at igs.manuals@brainlab.com if you have suggestions as to how we canimprove this manual.ManufacturerBrainlab AGKapellenstr. 1285622 FeldkirchenGermanyCleaning, Disinfection & Sterilization Guide Rev. 5.27
Contact Data and Legal Information1.1.2Legal InformationCopyrightThis guide contains proprietary information protected by copyright. No part of this guide may bereproduced 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/orother 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 theBrainlab 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 InstructionsWhen a surgical instrument reaches the end of its functional life, clean the instrument of allbiomaterial/biohazards and safely dispose of the instrument in accordance with applicable lawsand regulations.Only dispose of electrical and electronic equipment in accordance with statutoryregulations. For information regarding the WEEE (Waste Electrical and ElectronicEquipment) directive, leaning, Disinfection & Sterilization Guide Rev. 5.2
GENERAL INFORMATION1.2Symbols1.2.1Symbols Used in This GuideWarningsWarnings are indicated by triangular warning symbols. They contain safety-criticalinformation regarding possible injury, death or other serious consequences associatedwith equipment misuse.CautionsCautions are indicated by circular caution symbols. They contain safety-critical informationregarding possible problems with the device. Such problems include device malfunctions,device failure, damage to device or damage to property.NotesNOTE: Notes are formatted in italic type and indicate additional useful hints.Cleaning, Disinfection & Sterilization Guide Rev. 5.29
Symbols1.2.2Hardware SymbolsSymbols and Abbreviations on Hardware ComponentsSymbolExplanationType B Applied Part according to IEC 60601-1Type BF Applied Part according to IEC 60601-1CautionWarning, laser radiationPotential equalization pointMR SafeMR UnsafeMR Conditional: The number shown on each label specifies the MR environment inwhich the device can be used with cautionDo not reuseNon-SterileDo not resterilizeSterilized with ethylene oxideProduct manufactured with components that do not contain natural rubber latexFragile, handle with careDo not use if packaging is damagedKeep away from sunlight10Cleaning, Disinfection & Sterilization Guide Rev. 5.2
GENERAL INFORMATIONSymbolExplanationKeep dryStorage conditions for temperature: The specified temperature range is shown oneach label.Storage conditions for relative humidity non-condensing: The specified humidityrange is shown on each label.Storage conditions for air pressure: The specified air pressure range is shown oneach label.Quantity of products in packagingBatch numberSerial numberArticle numberUse by month YYYYDate of manufactureManufacturerAuthorized representative in the European CommunityIPXYIngress Protection according to IEC 60529 X Protection against ingress of solid objects Y Protection against ingress of liquidOn/off switchStandby switch to bring the device into standby modeAcoustic power output of integrated ultrasound probes complies with FDA Track 3and IEC 60601-2-37Consult the operating instructionsCleaning, Disinfection & Sterilization Guide Rev. 5.211
SymbolsSymbolExplanationFollow the instructions for use12Cleaning, Disinfection & Sterilization Guide Rev. 5.2
GENERAL INFORMATION1.3Hardware1.3.1Using the HardwareCareful Hardware HandlingOnly trained medical personnel may operate system components and accessoryinstrumentation.As Brainlab navigation instruments are precalibrated, handle all parts with extreme care.System components and accessory instrumentation comprise precise mechanical parts.Handle them carefully.Cleaning, Disinfection & Sterilization Guide Rev. 5.213
Documentation1.4Documentation1.4.1User GuidesReading User GuidesThe user guides describe complex medical devices and surgical navigation software that must beused 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 timesAvailable User GuidesUser GuideSoftware User Guides14Contents Overview of treatment planning and image-guided navigation Description of OR system setup Detailed software instructionsInstrument User GuidesDetailed instructions on instrument handlingCleaning, Disinfection andSterilization GuideDetails on cleaning, disinfecting and sterilizing instrumentsSystem User GuidesComprehensive information on system setupTechnical User GuideDetailed technical information on the system, including specifications and compliancesCleaning, Disinfection & Sterilization Guide Rev. 5.2
REPROCESSING2REPROCESSING2.1Initial Use and Re-Use of Instruments2.1.1Fundamental NotesResponsibility Use only approved devices (washer-disinfector, sterilizer) and validated product-specificprocedures Apply the validated parameters in each re-use cycle Pay close attention to your hospital’s hygiene guidelinesThe reprocessing personnel are responsible for ensuring that reprocessing achieves thedesired 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 foreffectiveness and potential adverse effects. If processes are altered, the desired effect maynot be achieved. Brainlab excludes any liability in this case.Only use reprocessing procedures described in this guide. Other procedures could resultin material damage, corrosion, fatigue, breakage, or decrease the weight bearing capabilityof the instrument.NOTE: All transparent packaging and other packaging, protective caps and foils etc. must beremoved before using the products.Disassembling InstrumentsDisassemble/reassemble/unscrew instruments as described in the corresponding sections.DisposablesFigure 1Disposable products are for single-use only. Do not attempt to reprocess any disposables.Cleaning, Disinfection & Sterilization Guide Rev. 5.215
Initial Use and Re-Use of InstrumentsDisposable Reflective Marker SpheresReflective marker spheres are for single-use only. Do not re-sterilize them, as sterilizationmay lead to reduced accuracy and endanger patient safety.Unscrew reflective marker spheres from all instrument components and dispose of themprior to component reprocessing.Reprocessing InstrumentsEffective cleaning and disinfection is essential for effective instrumentation sterilization.Follow the instructions for each individual instrument, as each instrument may be processeddifferently.Ensure that all components (threads, guidances, etc.) are thoroughly cleaned, disinfected andsterilized, according to the following table and its respective instrument section:StepProcedureSee1.PretreatmentPage 182.Automated or manual cleaning and disinfectionPage 193.Post-dryingPage 234.Instrument usability checkPage 235.PackagingPage 266.Steam (preferred) or LTP sterilizationPage 26
Sterilization Trays for Steam Sterilization (18099-07, 18099-08, 18099-08A).162 TABLE OF CONTENTS Cleaning, Disinfection & Sterilization Guide Rev. 5.2 5. INTRAOPERATIVE IMAGING INSTRUMEN
WFHSS-ÖGSV Basic Script Fundamentals of Cleaning, Disinfection, Sterilization Page2/30 TABLE OF CONTENTS . 1 TERMS 3 1.1 Cleaning 3 1.2 Disinfection 3 1.3 Sterilization 3 2 CLEANING 4 2.1 Detergents and methods of cleaning (summary) 5 3 DISINFECTION 7 3.1 Chemical disinfection 8 3.2 Thermal disinfection 17
Slide 1 Welcome to Cleaning, Disinfection & Sterilization, Part 2 of 2. Slide 2 One way to achieve sterilization is with steam. Steam sterilization uses 4 parameters to achieve sterilization. These include the
Basics of Cleaning, Disinfection & Sterilization for Health Care Dr. Lynne Sehulster, CDC A Webber Training Teleclass Hosted by Paul Webber paul@webertraining.com www.webbertraining.com 1 Basic Principles of Cleaning, Disinfection, and Sterilization in Health Care Lynne Sehulst
Best Practice Guidelines for Cleaning, Disinfection and Sterilization in Health Authorities - December 2011 Page 1 of 136 pages Semi Best Practice Guidelines For Cleaning, Disinfection . D. Reprocessing Products.40 8. DISINFECTION OF REUSABLE MEDICAL DEVICES .
Because sterilization of all patient-care items is not necessary, health-care policies must identify, primarily on the basis of the items' intended use, whether cleaning, disinfection, or sterilization is indicated. Multiple studies in many countries have documented lack of compliance with established guidelines for disinfection and sterilization.
Cleaning, Disinfection & Sterilization Guidelines for Ultrasound System 13 Strain relief Probe handle Liquid level Approx.10 mm - Wiping: Use a market disinfection wipe product or sterile disposable lint-free soft cloth wetted with disinfection spray and wipe all surfaces of the probe for a duration according to the manufacturer instructions. 4.
Disinfection . Failure to use disinfection products or processes appropriately . has repeatedly been associated with the transmission of . healthcare associated infections. Health Canada. Hand Washing, Cleaning, Disinfection and Sterilization. CCDR. 1998; 24S8
in Administrative Organization, Third Edition, The Free Press, Collier Macmillan Publishers, London, UK, 1976. Background Herbert A. Simon was 31 years old when he published his book "Administrative Behavior" (Simon, 76) in 1947. The aim of the book was to show how organizations can be understood in terms of their decision processes (Simon, 76, pp. ix & xxv). His central point is that decision .
