CLEANING, DISINFECTION AND STERILIZATION GUIDE Revision 5.2 Copyright 2016, Brainlab AG Germany. All rights reserved. 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 3 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