Aesculap Orthopaedics Hip Platform - USA

Similar documents
Aesculap Implant Systems

CHIMNEY CENTRIFUGAL FAN KAMIN OPERATION MANUAL

Aesculap Implant Systems

Wireless keypad RKB1. Data sheet. Device identification number:

t Instruction Manual GAS BBQ "Bloomfield" Version 2017, Item No. 3160UK

Automatic Burner Controls IFS 110 IM

Built-in oven INSTRUCTION MANUAL C17MR02.0B

Compact oven with microwave. CM636GB.1 siemens-home.com/welcome. Register your product online

Dishwasher SHEM78WH5N. en-us Operating instructions fr-ca Notice d'utilisation

General-Purpose AC Servo. MELSERVO-J4 Servo amplifier INSTRUCTION MANUAL TROUBLE SHOOTING

Configuration Software G3800 X015. User Manual Preliminary Data December 2002

INSTALLATION AND OPERATING MANUAL

< Apparecchiatura di controllo di fiamma > RIVELAZIONE FIAMMA MONO - BI ELETTRODO. SAITEK srl

UNIVERSAL QUERSTROMZERSPANER UNI-CUT Series QZ

EBA 20 EBA 20 C Repair instructions

UF GENERAL DESCRIPTION 2. SHORT-FORM DATA 3. ORDER NUMBERS 4. MARKINGS BUFFER UNIT 1/11

L4188A,B; L4189A,B; L6188A-C; L6189A-C Aquastat Controllers

User Manual. If you have any issues or questions, please contact us via

FC121-ZA / FC122-ZA / FC123-ZA / FC124-ZA

SWIMMING POOL HEAT PUMP UNITS. Installation & Instruction Manual DURA+ - series

ir33+ Electronic controller User manual

The effect of the fire detectors on gas turbine reliability

SmartCella/SmartCella 3PH. Electronic controllers for cold rooms. User manual NO POWER & SIGNAL CABLES TOGETHER READ CAREFULLY IN THE TEXT!

I' I ', \~ Minnesota Extension Service University of Minnesota. AG-Ml-0556 Revised Leonard B. Hertz. (After) (Before) I,, l.

User manual. EVD evolution twin. Driver for 2 electronic expansion valves. Integrated Control Solutions & Energy Savings READ CAREFULLY IN THE TEXT!

Single Package Heat Pump. important:

ir33+ platform ir33+, ir33+wide, ir33+ small wide easy wide y easy small wide Electronic controller User manual

MEMOIRSS ORDERING INFORMATION NOTES T01-A INSTALLATION INSTRUCTIONS (4.8L) VITREOUS CHINA ONE-PIECE TOILET(4.8L) K-3451T-*/K-3453T-*

R8182D,E,F,H,J Combination Protectorelay Primary Control and Aquastat Controller

Process firing system PF 19

UltraCella. Electronic control for Cold Rooms. User manual NO POWER & SIGNAL CABLES TOGETHER READ CAREFULLY IN THE TEXT!

L8151A Triple Aquastat Relay

User manual. EVD evolution. electronic expansion valve driver. Integrated Control Solutions & Energy Savings READ CAREFULLY IN THE TEXT!

Exercises in causal loop diagrams (CLD s)

Two-Stage Compression Centrifugal Chiller

AS Medizintechnik GmbH Sattlerstrasse 15, Tuttlingen, Germany Tel 07461/ Fax 07461/

Technical Data. Specifications are typical and given at 23 C & 50% relative humidity unless stated.

MEMOIRS ORDERING INFORMATION T01-L INSTALLATION INSTRUCTIONS

KATHRYN ORDERING INFORMATION NOTES T01-A INSTALLATION INSTRUCTIONS 4.8 TM COMFORT HEIGHT 1-PC EB TOILET K-3940

CONVENTUS CAGE TM PH Procedure Instruments Instrument Tray Cleaning and Sterilization

Compressed Air Dryers

CONVENTUS CAGE TM PH Procedure Instruments Instrument Tray Cleaning and Sterilization

EVD evolution. electronic expansion valve driver. User manual. Integrated Control Solutions & Energy Savings

MEMOIRS ORDERING INFORMATION T01-K INSTALLATION INSTRUCTIONS

Instruction of use. Flexible Naso-Pharyngo- Laryngofiberscope,

RIALTO HOW TO USE THESE INSTRUCTIONS ORDERING INFORMATION NOTES T01-A INSTALLATION INSTRUCTIONS


L4006,7,8; L6006,7,8 Aquastat Controllers

UltraCella. Electronic control for Cold Rooms. User manual NO POWER & SIGNAL CABLES TOGETHER READ CAREFULLY IN THE TEXT!

MTS 5100 Media Test Set. Mini OTDR and Optical Test Set for Fiber Networks. Wavetek MTS-5100 Specs Provided by

CLEANING INSTRUCTIONS

PADDY DRYING IN A VIBRATION-ASSISTED VACUUM INFRARED DRYER

Performance Rating of Central Station Air-handling Unit Supply Fans

Instructions for Use Spinal Punches IFU

Q7100A,C Thermostat Subbases

Doepke. ProLine NG. Configuration Software for the Dupline Bus System. User Manual. ProLine NG Version 1.20 and newer. May 2010, Version 1.

ADAIR ORDERING INFORMATION NOTES T01-A INSTALLATION INSTRUCTIONS VITREOUS CHINA TWO-PIECE TOILET K-9338T/K-9338T-S

I.F.U Re/Processing Reusable Medical Devices

L7224A,C; L7248A,C,L Oil Electronic Aquastat Controllers

Why Mendel Succeeded. Why Mendel Succeeded. Mendel chose his subject carefully. Mendel chose his subject carefully. Mendel chose his subject carefully

THE EFFECTIVENESS OF FIRE DETECTION SYSTEMS IN DIFFERENT DIMENSIONS ÚČINNOSŤ SYSTÉMOV POŽIARNEJ DETEKCIE V RÔZNYCH ROZMEROCH

ASHRAE Standard Solutions Guide. Real-World Applications and Single Source Compliance Strategies

RONALD G. BILLY JR. THIS ADDENDUM CONSISTS OF THREE (3) PAGES AND ATTACHMENTS:

EMAX 2 PLUS AND XMAX CLEANING AND STERILIZATION BASKET. Mechanical/Automated Cleaning and Sterilization Guide in a Variety of Applications

INSTALLATION AND USERS GUIDE

Q7100A,C,D Thermostat Subbases

Stainless Steel Condensing Boiler Connection Instructions To Additional Heating Devices

Analysis on the Operating Characteristics of a Household Dehumidifier

CONVENTUS CAGE TM - DR Procedure Instruments Instrument Tray. Equipment Cleaning and Sterilization

ComPact Air Drive II USER S MANUAL

ADVANCED TAPCHANGER CONTROL TO COUNTERACT POWER SYSTEM VOLTAGE INSTABILITY

Q7300L Series 2000 Commercial Thermostat Subbases

GCL design series Part 1: GCL performance as a fluid barrier

Integra Salto Talaris and Integra XT Non-Sterile Device Reprocessing. Instructions for Use. 4. Manual Cleaning Instructions

RESIDENTIAL & GARDEN LIGHTS

Highly efficient heat dissipation units using free cooling. Free Line. You can count on us...

Study on the quantitative feasibility of rainwater harvesting in small islands

MECHANICAL LINETYPE LEGEND MINIMUM MISC MISCELLANEOUS MEDIUM PRESSURE STEAM RETURN MEDIUM PRESSURE STEAM SUPPLY NOT TO SCALE OUTSIDE AIR

AS Medizintechnik GmbH Sattlerstrasse 15, Tuttlingen, Germany Tel 07461/ Fax 07461/

Engineer Programming Quick Guide

O-6. Mechanical 008 REFER TO ENLARGED MECHANICAL ROOM PLAN. Electrical. Basement Storage. Hallway 009. Theater Storage 010 TYPICAL CEILING MOUNTED

Table of Contents. English

Instructions for Use. Air Power Line II. Power tools for endoprosthetics and traumatology.

Geometric Shapes Generation in Songket Designs Using Shape Grammar

Significant Earnings Growth Opportunities. Christopher Coughlin Executive Vice President and CFO

FLASH PAK STERILIZATION CONTAINER SYSTEM

Morgan Stanley Global Industrials CEOs Unplugged Conference

The Curators of the University of Missouri

L7224A,C; L7248A,C,L Oil and Electric Boiler Electronic Aquastat Controllers

Q7300H Series 2000 Commercial Thermostat Subbases

INSTRUCTION MANUAL W-400

CAUTION: ELECTRICAL HAZARD

SOLAR FEATURES TANK FEATURES

Complex constrained CA urban model: Long-term urban form prediction for Beijing metropolitan area

mini-kool series INSTALLATION, OPERATION & MAINTENANCE rev 05/01

INSTRUCTIONS FOR USE & STERILIZATION FOR INSTRUMENTS

International Journal of Engineering Research & Science (IJOER) ISSN: [ ] [Vol-2, Issue-10, October- 2016]

MODEL CW MANUFACTURER WATER CLOSET ADA COMPLIANT AMERICAN STANDARD (OR APPROVED EQUAL) CHAMPION PRO 211AA.104 CADET PEDESTAL SINK

SterilContainer S for use in the Steris V-PRO 60 Low Temperature Sterilization System

USER S MANUAL WITH REFERENCE TO THE STANDARDS IN USE FLYWHEEL SLICERS MOD. 370V-330V

Transcription:

Aesculap Orhopaedics Hip Plaform USA Page Page Page 6 Page Page Page Page 9 nsrucions for use/technical descripion Orhopedic and Traumaology nsrumen Ses nsrucions for use/technical descripion Ben cup nserion nsrumen wih Thread nsrucions for use/technical descripion Flexible shaf for drill bis nsrucions for use Hinge screwdriver SW. nsrucions for use Screwdriver SW, SOP AS 0009 (TA00) TA00 TA00 TA00 TA00 nsrucions for use nserion insrumen for sealing cap, ben nsrucions for use/technical descripion Deph Gauge SOP AS 00 (TA00) TA006 9 Page 0 nsrucions for use Targeing devices SOP AS 00 (TA009) Page 0 nsrucions for use/technical descripion Universal argeing device for he supine and laeral posiion SOP AS 006 (TA00) Page nsrucions for use/technical descripion Aceabular reamers and sandard reamer shafs SOP AS 00 (TA06) Page nsrucions for use/technical descripion Mios reamer shaf SOP AS 000 (TA06) Page nsrucions for use/technical descripion THA rasp handle SOP AS 00 (TA0) Page nsrucions for use/technical descripion nsrumen se: Excia T TA06 SOPAS000 Rev. / Page

Preparaions a he place of use TANr. 00 Orhopedic and raumaology insrumen ses / Änd.Nr. 09 f applicable, rinse nonvisible surfaces preferably wih deionized waer, wih a disposable syringe for example. Remove any visible surgical residues o he exen possible wih a damp, linfree cloh. Transpor he dry produc in a sealed wase conainer for cleaning and disinfecion wihin 6 hours. Preparaions before cleaning Symbols on produc and packages Cauion, general warning symbol Cauion, see documenaion supplied wih he produc Fixaion screws which permanenly connec he various componens mus no be disassembled. Disassemble separable insrumen (e.g. wih se screws) prior o cleaning. Fixaion screws which connec he various componens mus no be disassembled Producspecific safey noes on he reprocessing procedure Use cleaning and disinfecing agens according o he manufacurer s insrucions which are approved for use, for example, on aluminum, plasic maerials, and highgrade seel, do no aack sofeners (e.g. in silicone). Observe specificaions regarding concenraion, emperaure and exposure Do no exceed he maximum permied cleaning emperaure of 0 C. Scope These insrucions for use apply o insrumens wih lumens or indenaions, as well as collapsible insrumens ha are composed enirely or in par of nonsensive maerials (e.g. sainless seel, PEEK or silicon). The orhopedic/raumaology insrumen se is used in orhopedic or rauma surgery, e.g. for procedures involving implanaions of endoprosheses or fracure implans. Safe handling and preparaion Federal law resrics his device o sale by, or on order of a physician! Ensure ha he produc and is accessories are operaed and used only by persons wih he requisie raining, knowledge, or experience. Read, follow, and keep he insrucions for use. Use he produc only in accordance wih is inended use, see. Remove he ranspor packaging and clean he new produc, eiher manually or mechanically, prior o is iniial serilizaion. Sore any new or unused producs in a dry, clean, and safe place. Prior o each use, inspec he produc for loose, ben, broken, cracked, worn, or fracured componens. Do no use he produc if i is damaged or defecive. Se aside he produc if i is damaged. Replace any damaged componens immediaely wih original spare pars. Operaion Do no use oxidizing chemicals (e.g. HO), which could cause bleaching/layer loss of he produc. Use suiable cleaning/disinfecing agens if he produc is pu away in a we condiion. To preven foam forma ion and reduced effeciveness of he process chemicals: Prior o mechanical cleaning and disinfecion, rinse he produc horoughly wih running waer. Moun jaws proecion on he produc. Manual cleaning wih immersion disinfecion Chaper Manual cleaning/disinfecion and subchaper: Manual precleaning wih brush and subsequen mechanical alkaline cleaning and hermal disinfecion Always carry ou a funcion check prior o using he produc. Validaed reprocessing procedure General safey insrucions Adhere o naional sauory regulaions, naional and inernaional sandards and direcives, and local, clinical hygiene insrucions for serile processing. 0 ml disposable syringe Drying phase: Use a linfree cloh or medical compressed air Chaper Manual cleaning wih immersion disinfecion Chaper Mechanical cleaning/disinfecion wih manual precleaning and subchaper: 0 ml disposable syringe Connec componens wih lumens and channels direcly o he rinsing por of he injecor carriage. Chaper Manual precleaning wih a brush Keep working ends open for cleaning. Place insrumens in he ray wih heir hinges open. Manual cleaning/disinfecion Prior o manual disinfecing, allow waer o drip off for a sufficien lengh of ime o preven diluion of he dis infecing soluion. For paiens wih CreuzfeldJakob disease (CJD), suspeced CJD or possible varians of CJD, observe he relevan naional regulaions concerning he reprocessing of producs. Afer manual cleaning/disinfecion, check visible surfaces visually for residues. Repea he cleaning /disinfecion process if necessary. Mechanical reprocessing should be favored over manual cleaning as i gives beer and more reliable resuls. Manual cleaning wih immersion disinfecion Successful processing of his medical device can only be ensured if he processing mehod is firs validaed. The operaor/serile processing echnician is responsible for his. The recommended chemisry was used for validaion. Phase Sep T Conc. [%] qualiy Disinfecing cleaning > Aldehydefree, phenolfree, and QUATfree concenrae, ph ~ 9 nermediae rinse Disinfecion Aldehydefree, phenolfree, and QUATfree concenrae, ph ~ 9 V Final rinse FDW V Drying RT f here is no final serilizaion, hen a virucidal disinfecan mus be used. For he laes informaion on reprocessing and maerial compaibiliy see also he Aesculap exrane a www.exrane.bbraun.com The validaed seam serilizaion procedure was carried ou in he Aesculap serile conainer sysem. General informaion Dried or affixed surgical residues can make cleaning more difficul or ineffecive and lead o corrosion. Therefore he ime inerval beween applicaion and processing should no exceed 6 h; also, neiher fixaing precleaning emperaures > C nor fixaing disinfecing agens (acive ingredien: aldehydes/alcohols) should be used. Excessive measures of neuralizing agens or basic cleaners may resul in a chemical aack and/or o fading and he laser marking becoming unreadable visually or by machine for sainless seel. Residues conaining chlorine or chlorides e.g. in surgical residues, medicines, saline soluions and in he service waer used for cleaning, disinfecion and serilizaion will cause corrosion damage (piing, sress corrosion) and resul in he desrucion of sainless seel producs. These mus be removed by rinsing horoughly wih demineralized waer and hen drying. Addiional drying, if necessary. Only process chemicals ha have been esed and approved (e.g. VAH or FDA approval or CE mark) and which are compaible wih he produc s maerials according o he chemical manufacurers recommendaions may be used for processing he produc. All he chemical manufacurer's applicaion specificaions mus be sricly observed. Failure o do so can resul in he following problems: Opical changes of maerials, e.g. fading or discoloraion of ianium or aluminum. For aluminum, he applicaion/process soluion only needs o be of ph > o cause visible surface changes. Maerial damage such as corrosion, cracks, fracuring, premaure aging or swelling. Do no use meal cleaning brushes or oher abrasives ha would damage he produc surfaces and could cause corrosion. Furher deailed advice on hygienically safe and maerial/valuepreserving reprocessing can be found a www.aki.org, link o Publicaions, Red Brochure Proper mainenance of insrumens. : F: RT: Drinking waer Fully desalinaed waer (demineralized, low microbiological conaminaion: drinking waer qualiy a leas) Room emperaure he informaion on appropriae cleaning brushes and disposable syringes, see Validaed cleaning and dis infecion procedure. Phase Fully immerse he produc in he cleaning/disinfecan for a leas min. Ensure ha all accessible surfaces are moisened. Clean he produc wih a suiable cleaning brush in he soluion unil all discernible residues have been removed from he surface. f applicable, brush hrough nonvisible surfaces wih an appropriae cleaning brush for a leas min. Mobilize nonrigid componens, such as se screws, links, ec. during cleaning. Thoroughly rinse hrough hese componens wih he cleaning disinfecan soluion (a leas five imes), using a disposable syringe. Page

Packaging Phase Rinse/flush he produc horoughly (all accessible surfaces) under running waer. Mobilize nonrigid componens, such as se screws, joins, ec. during rinsing. Drain any remaining waer fully. Place he produc in is holder or on a suiable ray. Pack rays appropriaely for he inended serilizaion process (e.g. in serile Aesculap conainers). Ensure ha he packaging provides sufficien proecion agains reconaminaion of he produc during sorage. Phase Fully immerse he produc in he disinfecan soluion. Mobilize nonrigid componens, such as se screws, joins, ec. during rinsing. Rinse lumens a leas imes a he beginning of he exposure ime using an appropriae disposable syringe. Ensure ha all accessible surfaces are moisened. Phase V Rinse/flush he produc horoughly (all accessible surfaces). Mobilize nonrigid componens, such as se screws, joins, ec. during final rinse. Rinse lumens wih an appropriae disposable syringe a leas five imes. Drain any remaining waer fully. Mechanical cleaning/disinfecion wih manual precleaning The cleaning and disinfecion device mus be of esed and approved effeciveness (e.g. FDA approval or CE mark according o DN EN SO ). The cleaning and disinfecion device used for processing mus be serviced and checked a regular inervals. Manual precleaning wih a brush : RT: Sep Aesculap advises agains serilizing he device by flash serilizaion or chemical serilizaion. Serilizaion may be accomplished by a sandard prevacuum cycle in a seam auoclave. To achieve a seriliy assurance level of 06, Aesculap recommends he following parameers: Aesculap Orga Tray/Serile conainer (perforaed boom) Minimum cycle parameers* Phase V Dry he produc in he drying phase wih suiable equipmen (e.g. cloh, compressed air), see Validaed cleaning and disinfecion procedure. Phase Seam serilizaion Serilizaion mehod Temp. Time Minimum drying ime Prevacuum 0 F/ F min 0 min *Aesculap has validaed he above serilizaion cycle and has he daa on file. The validaion was accomplished in an Aesculap serile conainer cleared by FDA for he serilizaion and sorage of hese producs. Oher serilizaion cycles may also be suiable, however individuals or hospials no using he recommended mehod are advised o validae any alernaive mehod using appropriae laboraory echniques. Use an FDA cleared accessory o mainain seriliy afer processing, such as a wrap, pouch, ec. Sorage Sore serile producs in germproof packaging, proeced from dus, in a dry, dark, emperaureconrolled area. Technical Service T Conc. [%] qualiy Disinfecan cleaning > Aldehydefree, phenolfree, and QUATfree concenrae, ph ~ 9 Rinsing Do no modify he produc. For service and repairs, please conac your naional B. Braun/Aesculap agency. Modificaions carried ou on medical echnical equipmen may resul in loss of guaranee/warrany righs and forfeiure of applicable licenses. Drinking waer Room emperaure he informaion on appropriae cleaning brushes and disposable syringes, see Validaed cleaning and dis infecion procedure. Phase Fully immerse he produc in he cleaning/disinfecan for a leas min. Ensure ha all accessible surfaces are moisened. Clean he produc wih a suiable cleaning brush in he soluion unil all discernible residues have been removed from he surface. f applicable, brush hrough nonvisible surfaces wih an appropriae cleaning brush for a leas min. Mobilize nonrigid componens, such as se screws, links, ec. during cleaning. Thoroughly rinse hrough hese componens wih he cleaning disinfecan soluion (a leas five imes), using a disposable syringe. Aesculap mplan Sysems LLC An. Aesculap Technical Services 6 Lamber Poine Drive Hazelwood MO, 60 Aesculap Repair Holine Phone: + (00) 9 Fax: + () 90 Oher service addresses can be obained from he address indicaed above. Disposal Adhere o naional regulaions when disposing of or recycling he produc, is componens and is packaging! Phase Rinse/flush he produc horoughly (all accessible surfaces) under running waer. Mobilize nonrigid componens, such as se screws, joins, ec. during rinsing. Mechanical alkaline Machine ype: singlechamber cleaning/disinfecion device wihou ulrasound Phase Sep T qualiy Prerinse </ Cleaning / 0 FDW Concenrae, alkaline: ph = < % anionic surfacan 0. % working soluion ph = nermediae rinse >0/0 FDW V Thermal disinfecing 90/9 FDW V Drying According o he program for cleaning and disinfecion device : F: Drinking waer Fully desalinaed waer (demineralized, low microbiological conaminaion: drinking waer qualiy a leas) Check visible surfaces for residues afer mechanical cleaning/disinfecing. nspecion, mainenance and checks Allow he produc o cool down o room emperaure. Afer each complee cleaning, disinfecing and drying cycle, check ha he insrumen is dry, clean, operaional, and free of damage (e.g. broken insulaion or corroded, loose, ben, broken, cracked, worn, or fracured componens). Dry he produc if i is we or damp. Repea cleaning and disinfecion of producs ha sill show impuriies or conaminaion. Check ha he produc funcions correcly. mmediaely pu aside damaged or inoperaive producs and send hem o Aesculap Technical Service, see Technical Service. Check for compaibiliy wih associaed producs. Page

Änd.Nr. 9 Ben cup inserion insrumen wih hread TANr. 00 0/ Änd.Nr. 9060 NTR mpac plae Universal hread Universal join NTR NT6R ND6R The ben inserion insrumen is used o implan, and if necessary explan, Aesculap hip cups. The ben shape enables operaions o be performed ha are minimally invasive and genle on he sof issue. Producspecific safey noes on he reprocessing procedure Always carry ou a funcion check prior o using he produc. Breakage of componens if he orque is oo high! Use only he inended screwdriver o ighen and fasen he cup. Do no cause an increase in orque by urning he cup opposie he complee impacor. mplanaion The inserion insrumen is applied cenrally ono he adapion sie of he cup. Ensure ha i is correcly seaed in place. The explanaion plae NT6R can be used for improved roaion conrol. Apply he inserion insrumen cenrally ono he adapion sie of he cup. Ensure ha i is correcly seaed in place. Use cleaning and disinfecing agens approved for, e.g., aluminum, plasics and highgrade seel, according o he manufacurer s insrucions. Observe specificaions regarding concenraion, emperaure and exposure Do no exceed he maximum permied cleaning emperaure of 96 C. Do no use oxidizing chemicals (e.g. HO), which could cause bleaching/layer loss of he produc. Use suiable cleaning/disinfecing agens if he produc is pu away in a we condiion. To preven foam forma ion and reduced effeciveness of he process chemicals: Prior o mechanical cleaning and disinfecion, rinse he produc horoughly wih running waer. Carry ou ulrasound cleaning: as an effecive mechanical supplemen o manual cleaning/disinfecion. as a precleaning procedure for producs wih encrused residues, in preparaion for mechanical cleaning/ disinfecion. as an inegraed mechanical suppor measure for mechanical cleaning/disinfecion. for addiional cleaning of producs wih residues lef afer mechanical cleaning/disinfecion. Manual cleaning wih ulrasound and immersion disinfecion 0 ml disposable syringe Chaper Manual cleaning/disinfec Drying phase: Use a linfree cloh or medical compressed air nser screwdriver NTR ino he opening of he inserion insrumen. Connec screwdriver NTR wih he universal join. Screw universal hread ino he cup by urning clockwise wih screwdriver NTR; his will clamp he inserion insrumen wih he cup. Explanaion Prior o explanaion, he inserion insrumen is clamped wih he cup following he procedure described in he 'implanaion' secion, see mplanaion nser explanaion plae NT6R ino one of he holes under he impac plae, unil he cone jams. Manual precleaning wih ulrasound and brush, and subsequen mechanical alkaline cleaning and hermal disinfecion 0 ml disposable syringe Connec componens wih lumens and channels direcly o he rinsing por of he injecor carriage. ion and subchaper: Chaper Manual cleaning wih ulrasound and immersion disinfecion Chaper Mechanical cleaning/disinfecion wih manual precleaning and subchaper: Chaper Manual precleaning wih ulrasound and brush Caper Mechanical alkaline Explan he hip cup by applying srong hammer blows o he explanaion plae NT6R. Page

Manual cleaning/disinfecion Prior o manual disinfecing, allow waer o drip off for a sufficien lengh of ime o preven diluion of he disinfecing soluion. Afer manual cleaning/disinfecion, check visible surfaces visually for residues. Repea he cleaning /disinfecion process if necessary. Manual cleaning wih ulrasound and immersion disinfecion : F: RT: Phase Sep T Ulrasonic cleaning nermediae rinse Conc. [%] qualiy he informaion on appropriae cleaning brushes and disposable syringes, see Validaed cleaning and disinfecion procedure. Phase Clean he produc in an ulrasonic cleaning bah (frequency khz) for a leas min. Ensure ha all accessible surfaces are immersed and acousic shadows are avoided. Clean he produc wih a suiable cleaning brush in he soluion unil all discernible residues have been removed from he surface. f applicable, brush hrough nonvisible surfaces wih an appropriae cleaning brush for a leas min. Mobilize nonrigid componens, such as se screws, links, ec. during cleaning. Thoroughly rinse hrough hese componens wih he cleaning disinfecan soluion (a leas five imes), using a disposable syringe. Phase Rinse/flush he produc horoughly (all accessible surfaces) under running waer. Mobilize nonrigid componens, such as se screws, joins, ec. during rinsing. Drain any remaining waer fully. Phase Fully immerse he produc in he disinfecan soluion. Mobilize nonrigid componens, such as se screws, joins, ec. during rinsing. Rinse lumens a leas five imes a he beginning of he exposure ime wih an appropriae disposable syringe. Ensure ha all accessible surfaces are moisened. Phase V Rinse/flush he produc horoughly (all accessible surfaces) under running waer. Mobilize nonrigid componens, such as se screws, joins, ec. during final rinse. Rinse lumens wih an appropriae disposable syringe a leas five imes. Drain any remaining waer fully. > Aldehydefree, phenolfree, and QUATfree concenrae, ph ~ 9 Disinfecion Aldehydefree, phenolfree, and QUATfree concenrae, ph ~ 9 V Final rinse FDW V Drying RT Drinking waer Fully desalinaed waer (demineralized, low microbiological conaminaion: drinking waer qualiy a leas) Room emperaure Phase V Dry he produc in he drying phase wih suiable equipmen (e.g. cloh, compressed air), see Validaed cleaning and disinfecion procedure. Mechanical cleaning/disinfecion wih manual precleaning The cleaning and disinfecion device mus be of esed and approved effeciveness (e.g. FDA approval or CE mark according o DN EN SO ). The cleaning and disinfecion device used for processing mus be serviced and checked a regular inervals. Mechanical alkaline Machine ype: singlechamber cleaning/disinfecion device wihou ulrasound Phase Sep T : F: qualiy Prerinse </ Drinking waer Fully desalinaed waer (demineralized, low microbiological conaminaion: drinking waer qualiy a leas) Check visible surfaces for residues afer mechanical cleaning/disinfecing. Cleaning / 0 FDW Concenrae, alkaline: ph = < % anionic surfacan 0. % working soluion ph = V nermediae rinse Thermal disinfecing >0/0 FDW 90/9 FDW V Drying According o he program for cleaning and disinfecion device * nspecion, mainenance and checks Allow he produc o cool down o room emperaure. Afer each complee cleaning, disinfecing and drying cycle, check ha he insrumen is dry, clean, operaional, and free of damage (e.g. broken insulaion or corroded, loose, ben, broken, cracked, worn, or fracured componens). Dry he produc if i is we or damp. Repea cleaning and disinfecion of producs ha sill show impuriies or conaminaion. Check ha he produc funcions correcly. mmediaely pu aside damaged or inoperaive producs and send hem o Aesculap Technical Service, see Technical Service. Assemble dismounable producs, see Assembling. Check for compaibiliy wih associaed producs. Packaging Place he produc in is holder or on a suiable ray. Pack rays appropriaely for he inended serilizaion process (e.g. in serile Aesculap conainers). Ensure ha he packaging provides sufficien proecion agains reconaminaion of he produc during sorage. Seam serilizaion Aesculap advises agains serilizing he device by flash serilizaion or chemical serilizaion. Serilizaion may be accomplished by a sandard prevacuum cycle in a seam auoclave. To achieve a seriliy assurance level of 0 6, Aesculap recommends he following parameers: Aesculap Orga Tray/Serile conainer (perforaed boom) Minimum cycle parameers* Serilizaion mehod Temp. Time Minimum drying ime Prevacuum 0 F/ F min 0 min Aesculap has validaed he above serilizaion cycle and has he daa on file. The validaion was accomplished in an Aesculap serile conainer cleared by FDA for he serilizaion and sorage of hese producs. Oher serilizaion cycles may also be suiable, however individuals or hospials no using he recommended mehod are advised o validae any alernaive mehod using appropriae laboraory echniques. Use an FDA cleared accessory o mainain seriliy * afer processing, such as a wrap, pouch, ec. Sorage Sore serile producs in germproof packaging, proeced from dus, in a dry, dark, emperaureconrolled area. Manual precleaning wih ulrasound and brush Phase Sep T Conc. [%] qualiy Ulrasonic cleaning > Aldehydefree, phenolfree, and QUATfree concenrae, ph ~ 9 Rinsing : RT: Drinking waer Room emperaure he informaion on appropriae cleaning brushes and disposable syringes, see Validaed cleaning and disinfecion procedure. Phase Clean he produc in an ulrasonic cleaning bah (frequency khz) for a leas min. Ensure ha all accessible surfaces are immersed and acousic shadows are avoided. Clean he produc wih a suiable cleaning brush in he soluion unil all discernible residues have been removed from he surface. f applicable, brush hrough nonvisible surfaces wih an appropriae cleaning brush for a leas min. Mobilize nonrigid componens, such as se screws, links, ec. during cleaning. Thoroughly rinse hrough hese componens wih he cleaning disinfecan soluion (a leas five imes), using a disposable syringe. Phase Rinse/flush he produc horoughly (all accessible surfaces) under running waer. Mobilize nonrigid componens, such as se screws, joins, ec. during rinsing.

Flexible shaf for drill bis TANr. 00 0/ Änd.Nr. 9 Sleeve Flexible shaf Connecing link Drill Pin Symbols on produc and packages Locked posiion Unlocked posiion B C A Drill bis (e.g. NTR, NT6R, NT9R) are insered in o he flexible shaf o be used for predrilling drill holes for bone screws. Producspecific safey noes on he reprocessing procedure Risk o paiens! The produc mus only be cleaned mechanically! DANGER Always carry ou a funcion check prior o using he produc. nsering he drill and engaging he lock Press he sleeve in he direcion of he flexible shaf, urn i a counerclockwise direcion and click he pin ino he unlocked posiion, see Fig. B. The flexible shaf has been unlocked. nser he hexagon connecion of he drill compleely ino he flexible shaf. Move he sleeve back in he opposie direcion and bring he pin ino he locking posiion The drill is locked now., see Fig. C. Push sleeve in he direcion of he flexible shaf and urn counerclockwise. The sleeve can be removed. The drill can be removed. Use cleaning and disinfecing agens approved for, e.g., aluminum, plasics and highgrade seel, according o he manufacurer s insrucions. Observe specificaions regarding concenraion, emperaure and exposure Do no exceed he maximum permied cleaning emperaure of 0 C. Do no use oxidizing chemicals (e.g. HO), which could cause bleaching/layer loss of he produc. Use suiable cleaning/disinfecing agens if he produc is pu away in a we condiion. To preven foam forma ion and reduced effeciveness of he process chemicals: Prior o mechanical cleaning and disinfecion, rinse he produc horoughly wih running waer. Carry ou ulrasound cleaning: as an effecive mechanical supplemen o manual cleaning/disinfecion. as a precleaning procedure for producs wih encrused residues, in preparaion for mechanical cleaning/ disinfecion. as an inegraed mechanical suppor measure for mechanical cleaning/disinfecion. for addiional cleaning of producs wih residues lef afer mechanical cleaning/disinfecion. Assembling Slide sleeve ono flexible shaf and wih connecing link lock he sleeve in place, see Fig. A. The sleeve and flexible shaf are conneced. The pin is in he locked posiion. he produc before carrying ou he reprocessing procedure Disassemble he produc immediaely afer use, as described in he respecive insrucions for use. Manual precleaning wih ulrasound and brush, and subsequen mechanical alkaline cleaning and hermal disinfecion Chaper Mechanical cleaning/disinfecion wih manual precleaning and subchaper: Preparaions a he place of use f applicable, rinse nonvisible surfaces preferably wih deionized waer, wih a disposable syringe for example. Remove any visible surgical residues o he exen possible wih a damp, linfree cloh. Transpor he dry produc in a sealed wase conainer for cleaning and disinfecion wihin 6 hours. Preparaion before cleaning Dismanle he produc prior o cleaning, see. 0 ml disposable syringe Connec componens wih lumens and channels direcly o he rinsing por of he injecor carriage. Chaper Manual precleaning wih ulrasound and brush Page 6

Hinge screwdriver SW. TANr. 00 / Änd.Nr. 6 Hinge Spring Shaf Handle The hinge screwdriver SW. is used for screwing in bone screws wih a hexagon socke SW.. Always carry ou a funcion check prior o using he produc. Push spring over hinge ono shaf in he direcion of he arrow, see Fig.. Assembling Push spring away from shaf over hinge in he opposie direcion of he arrow. he produc before carrying ou he reprocessing procedure Disassemble he produc immediaely afer use, as described in he respecive insrucions for use. Open up insrumens wih hinges. Preparaion before cleaning Dismanle he produc prior o cleaning, see. Producspecific safey noes on he reprocessing procedure Use cleaning and disinfecing agens approved for, e.g., aluminum, plasics and highgrade seel, according o he manufacurer s insrucions. Observe specificaions regarding concenraion, emperaure and exposure Do no exceed he maximum permied cleaning emperaure of 0 C. Screwdriver SW, TANr. 00 / Manual precleaning wih ulrasound and brush, and subsequen mechanical alkaline cleaning and hermal disinfecion Chaper Mechanical cleaning/disinfecion wih manual precleaning and subchaper: 0 ml disposable syringe Place insrumens in he ray wih heir hinges open. Chaper Manual precleaning wih ulrasound and brush Änd.Nr. 6 The screw driver is used o screw in he cenral sealing cap of Plasmafi and o clamp he aceabular cup o he ben inserion insrumen (NTR). Manual cleaning wih ulrasound and immersion disinfecion Manual precleaning wih ulrasound and brush, and subsequen mechanical alkaline cleaning and hermal disinfecion Page Cleaning brush 0 ml disposable syringe Drying phase: Use a linfree cloh or medical compressed air 0 ml disposable syringe Chaper Manual cleaning/disinfecion and subchaper: Chaper Manual cleaning wih ulrasound and immersion disinfecion Chaper Mechanical cleaning/disinfecion wih manual precleaning and subchaper: Chaper Manual precleaning wih ulrasound and brush

nserion insrumen for sealing cap, ben TANr. 00 / Änd.Nr. 6 Core Locknu Tube Handle Producspecific safey noes on he reprocessing procedure The inserion insrumen is used o screw on he cenral sealing cap of Plasmafi. Always carry ou a funcion check prior o using he produc. Use cleaning and disinfecing agens approved for, e.g., aluminum, plasics and highgrade seel, according o he manufacurer s insrucions. Observe specificaions regarding concenraion, emperaure and exposure Do no exceed he maximum permied cleaning emperaure of 0 C. Carry ou ulrasound cleaning: as an effecive mechanical supplemen o manual cleaning/disinfecion. as a precleaning procedure for producs wih encrused residues, in preparaion for mechanical cleaning/ disinfecion. as an inegraed mechanical suppor measure for mechanical cleaning/disinfecion. for addiional cleaning of producs wih residues lef afer mechanical cleaning/disinfecion. Unscrew locknu from ube. Remove core wih locknu from ube. Assembling nser core in he direcion of he handle ino he ube. Screw locknu ono ube. Manual cleaning wih ulrasound and immersion disinfecion he produc before carrying ou he reprocessing procedure Disassemble he produc immediaely afer use, as described in he respecive insrucions for use. Preparaion before cleaning Deph gauge TANr. 006 / Chaper Manual cleaning/disinfecion and subchaper: Chaper Manual cleaning wih ulrasound and immersion disinfecion 0 ml disposable syringe Drying phase: Use a linfree cloh or medical compressed air Chaper Mechanical cleaning/disinfecion wih manual precleaning and subchaper: 0 ml disposable syringe Chaper Manual precleaning wih ulrasound and brush Änd.Nr. 6 Validaed HE DEPTH GAUGE S USED TO MEASURE SCREW HOLES FOR HP JONT CUPS procedure Manual cleaning wih immersion disinfecion EMOVE SCALE WTH WRE FROM THE TUBE Assembling Resricion of accuracy of measuremen if he ube and scale are no insalled in pairs! Maching pars have idenical pairing code numbers (e.g., see Fig. A) Only insall he ube and scale in pairs )NSERT WRE WTH SCALE THROUGH THE TUBE Preparaion before cleaning Dismanle he produc prior o cleaning, see. Page Manual precleaning wih ulrasound and brush, and subsequen mechanical alkaline cleaning and hermal disinfecion Dismanle he produc prior o cleaning, see. Manual precleaning wih brush and subsequen mechanical alkaline cleaning and hermal disinfecion 0 ml disposable syringe Keep working ends open for cleaning. Chaper Manual cleaning/disinfecion and subchaper: Chaper Manual cleaning wih immersion disinfecion Drying phase: Use a linfree cloh or medical compressed air 0 ml disposable syringe Chaper Mechanical cleaning/disinfecion wih manual precleaning and subchaper: Chaper Manual precleaning wih a brush

Targeing devices TANr. 009 / Änd.Nr. 6 Threaded rod Templae Bearer NTR NTR A NTR B NTR C NTR D NTR The argeing devices are used in hip cup implanaions as an orienaion guide for he surgeon. Depending on he surgical echnique, eiher he argeing device for supine posiion (NTR) or he argeing device for laeral posiion (NTR) is used. Producspecific safey noes on he reprocessing procedure Always carry ou a funcion check prior o using he produc. Use cleaning and disinfecing agens approved for, e.g., aluminum, plasics and highgrade seel, according o he manufacurer s insrucions. Observe specificaions regarding concenraion, emperaure and exposure Do no exceed he maximum permied cleaning emperaure of 0 C. Depending on he paien's posiion, selec eiher he argeing device for supine posiion (NTR) or he ar geing device for laeral posiion (NTR). Choose he correc side and on emplae use side L for lef and R for righ, see fig. A and B. Apply argeing devices o he impacor, see fig. C and D. Differen angles are indicaed on emplae as an orienaion guide. Manual cleaning wih immersion disinfecion Unscrew hreaded rod from bearer. he produc before carrying ou he reprocessing procedure Disassemble he produc immediaely afer use, as described in he respecive insrucions for use. Preparaion before cleaning Dismanle he produc prior o cleaning, see. Manual precleaning wih brush and subsequen mechanical alkaline cleaning and hermal disinfecion 0 ml disposable syringe Keep working ends open for cleaning. Chaper Manual cleaning/disinfecion and subchaper: Chaper Manual cleaning wih immersion disinfecion Drying phase: Use a linfree cloh or medical compressed air 0 ml disposable syringe Chaper Mechanical cleaning/disinfecion wih manual precleaning and subchaper: Chaper Manual precleaning wih a brush Page 9

Universal argeing device for he supine and laeral posiion 6 Threaded rod Finger knob Templae ndicaor Bearer Reaining clip Peg Slide TANr. 00 0/ Änd.Nr. 9 Symbols on produc and packages Cauion, general warning symbol Cauion, see documenaion supplied wih he produc Surgeon's direcion of vision The universal argeing device is used in hip replacemen surgery and specifically in he implanaion of a cup, as an orienaion aid for he surgeon. The argeing device can be individually adjused depending on he indicaion and operaing echnique. Always carry ou a funcion check prior o using he produc. 6 A symbol of a pair of eyes is marked on he slide. The pair of eyes shows from which side he surgeon mus view he slide o se he correc angle. The pair of eyes and paien posiion mus always be on he same side, see Fig.. The angles can be se in incremens of. Seing he paien posiion and firs posiion angle Remove bearer from slide. Se bearer o he required paien posiion (Laeral or Suspine), see Fig.. Se he deniculaion beween he bearer and slide o he required angle (inclinaion or aneversion). Reaach bearer o slide by releasing he spring. Seing he second posiion angle The correc side mus be observed and se on emplae accordingly wih L for Lef or R for Righ. Lif indicaor unil i is freely movable. Move indicaor o he correc posiion on emplae depending on he required angle, see Fig.. Se indicaor down again. The universal argeing device is now ready o use and can be mouned on he impacorn, see Fig.. Assembling Pull and hold emplae agains he spring ension in he direcion of finger knob. Align he groove of he bearer wih he rod on he peg, see Fig.. nser he peg ino he hole in he bearer as far as i will go. Roae he bearer around he peg, unil he slide is posiioned over he denificaion. Release he spring o lock he denificaion in place. Screw hreaded rod ino finger knob. To disassemble he produc, follow he seps for assembly in reverse order. he produc before carrying ou he reprocessing procedure Disassemble he produc immediaely afer use, as described in he respecive insrucions for use. Open up insrumens wih hinges. Preparaions a he place of use f applicable, rinse nonvisible surfaces preferably wih deionized waer, wih a disposable syringe for example. Remove any visible surgical residues o he exen possible wih a damp, linfree cloh. Transpor he dry produc in a sealed wase conainer for cleaning and disinfecion wihin 6 hours. Preparaion before cleaning Disassemble he produc prior o cleaning, see. Producspecific safey noes on he reprocessing procedure Risk o paiens! The produc mus only be cleaned mechanically! DANGER Use cleaning and disinfecing agens approved for, e.g., aluminum, plasics and highgrade seel, according o he manufacurer s insrucions. Observe specificaions regarding concenraion, emperaure and exposure Do no exceed he maximum permied cleaning emperaure of 0 C. Do no use oxidizing chemicals (e.g. HO), which could cause bleaching/layer loss of he produc. Use suiable cleaning/disinfecing agens if he produc is pu away in a we condiion. To preven foam forma ion and reduced effeciveness of he process chemicals: Prior o mechanical cleaning and disinfecion, rinse he produc horoughly wih running waer. Manual precleaning wih brush and subsequen mechanical alkaline cleaning and hermal disinfecion Chaper Mechanical cleaning/disinfecion wih manual precleaning and subchaper: 0 ml disposable syringe Connec componens wih lumens and channels direcly o he rinsing por of he injecor carriage. Chaper Manual precleaning wih a brush Keep working ends open for cleaning. Place insrumens in he ray wih heir hinges open. Page 0

Aceabular reamers and sandard reamer shafs TANr. 06 0/ Änd.Nr. 69 A B C D Sandard shaf wih nonnavigaed sleeve Sandard shaf wih navigaion sleeve Full profile reamer MOS low crosssecion reamer Rigid body adaper (for navigaion) Marking (for inserion deph) Adaper for reamer heads Locking mechanism Locking sleeve A B C D The aceabular reamers are used for preparing he implan bed for spherical hip cups. Producspecific safey noes on he reprocessing procedure Shaf adapers wih Harris, AO and Zimmer connecors are available for he individual moor handpieces. The sandard shaf is available eiher wih a nonnavigaed sleeve, see Fig. A, or wih a navigaion sleeve, see Fig. B. They are powered preferably by moor handpieces wih a maximum roaional speed of 00/ min. Breach of he pelvic floor or excessive size of he aceabulum due o applicaion of a sharp reamer or excessive pressure! Apply new reamers wih appropriae cauion. Take care o apply appropriae pressure. Prepare he aceabulum sep by sep, saring wih a small reamer. Make cerain ha he reamer profile is hemispherical. Normally, he end face of a fullprofile reamer, see Fig. C, corresponds o he correc inserion deph of he hip cup. For MOS low crosssecion reamers, see Fig. D, he inserion deph is indicaed by black marking. When he reamer baske is full: Sop he process and empy he reamer baske. A full reamer baske reduces he cuing performance and makes i difficul o open he shaf coupling. Use cleaning and disinfecing agens according o he manufacurer s insrucions which are approved for (e.g. aluminum, plasics, highgrade seel), do no aack sofeners (e.g. in silicone). Observe specificaions regarding concenraion, emperaure and exposure Do no exceed he maximum permied cleaning emperaure of 0 C. Do no use oxidizing chemicals (e.g. HO), which could cause bleaching/layer loss of he produc. Use suiable cleaning/disinfecing agens if he produc is pu away in a we condiion. To preven foam forma ion and reduced effeciveness of he process chemicals: Prior o mechanical cleaning and disinfecion, rinse he produc horoughly wih running waer. f bone or issue residue is presen, he insrumen mus be precleaned manually (using a brush). Validaed procedure Manual cleaning wih immersion disinfecion Chaper Manual cleaning/disinfec Releasing he reamer head Pull back locking mechanism and loosen he reamer head. This releases he reamer head. Dismouning he locking mechanism, see Fig. Turn and push back locking sleeve. Pull back locking mechanism. Mechanical alkaline cleaning and hermal disinfecion 0 ml disposable syringe Drying phase: Use a linfree cloh or medical compressed air Place he produc in a ray ha is suiable for cleaning Place producs in he ray wih heir hinges open. ion and subchaper: Chaper Manual cleaning wih immersion disinfecion Chaper Mechanical cleaning/disinfecing and subchaper: Assembling Mouning he locking mechanism, see Fig. Push locking mechanism ino adaper for reamer heads. Push forward and urn locking sleeve. Coupling a reamer head Pu he reamer head on adaper for reamer heads and urn he reamer head. The reamer head is locked. he produc before carrying ou he reprocessing procedure Disassemble he produc immediaely afer use, as described in he respecive insrucions for use. Preparaion before cleaning Dismanle he produc prior o cleaning, see. Page

Mios reamer shaf TANr. 06 09/ Änd.Nr. 0 6 9 0 Handle Ouer par Twocomponen inner par Adaper for reamers (bayone adaper) Locking sleeve, fronend Locking sleeve, rearend Adaper for moor nner shaf nner shaf bearing Joins Locking nu Navigaion ring Compaibiliy number 0 9 0 9 9 A The Mios reamer shaf is used in combinaion wih he appropriae Aceabular reamers for preparing he implan bed for hip cups. Shaf adapers wih Harris, AO and Zimmer coupling are available for he individual moor handpieces. The angled Mios reamer shaf is available as nonnavigable, see Fig. E, or wih rigidbody adaper for navigaion, see Fig. F. They are powered by moor handpieces wih a maximum roaional speed of 00 /min. Read and follow he Aesculap insrucions for use of aceabular reamers and reamer shafs, see TA06. Loosen rearend locking sleeve 6 by pushing and urning i. Pull ou wocomponen inner par owards he fron end. Release fronend locking sleeve by urning he sleeve. Unfold wocomponen inner par. Remove he inner shaf wih inner shaf bearing 9 and joins 0. B C Navigaed elemens To loosen, urn nu. To loosen he navigaion ring, push i in he direcion of he arrow, see Fig. F. Assembling D 6 Check ha all componens carry he same compaibiliy number, see Fig. G. Assembling of componens wih nonidenical compaibiliy numbers can lead o impaired funcionaliy of he produc. nser inner shaf wih inner shaf bearing 9 and joins 0 in one half of he inner par, see Fig. A. Place he second half of he inner par on he firs half. Push and simulaneously urn fronend locking sleeve o lock he bayone adaper, see Fig. C. nser he enire inner par in he ouer par, see Fig. B. Ensure ha he angled surfaces are lying on op of each oher. Adap he handle o he inended approach or posiioning echnique, see Adaping he handle.. Check for proper funcion by urning inner shaf by hand. Lock he reamer head o he reamer shaf via bayone adaper ; follow he insrucions for use of he reamer heads. Aach he power ool. 6 E Adaping he handle Loosen rearend locking sleeve 6 by pushing and urning i. Pull back handle, urn i o he inended posiion and engage i here. Close locking sleeve, rearend 6. he produc before carrying ou he reprocessing procedure Disassemble he produc immediaely afer use, as described in he respecive insrucions for use. Preparaion before cleaning Dismanle he produc prior o cleaning, see. F Producspecific safey noes on he reprocessing procedure Use cleaning and disinfecing agens according o he manufacurer s insrucions which are approved for highgrade seel, do no aack sofeners (e.g. in silicone). Observe specificaions regarding concenraion, emperaure and exposure Do no exceed he maximum permied cleaning emperaure of 0 C. Use suiable cleaning/disinfecing agens if he produc is pu away in a we condiion. To preven foam forma ion and reduced effeciveness of he process chemicals: Prior o mechanical cleaning and disinfecion, rinse he produc horoughly wih running waer. Carry ou ulrasound cleaning: as an effecive mechanical supplemen o manual cleaning/disinfecing. as a precleaning procedure for producs wih encrused residues, in preparaion for mechanical cleaning/ disinfecing. as an inegraed mechanical suppor measure for mechanical cleaning/disinfecing. for addiional cleaning of producs wih residues lef afer mechanical cleaning/disinfecing. G Manual cleaning wih ulrasound and immersion disinfecion 0 ml disposable syringe When cleaning producs wih movable hinges, ensure ha hese are in an open posiion and, if applicable, move he join while cleaning. Chaper Manual cleaning/disinfecion and subchaper: Chaper Manual cleaning wih ulrasound and immersion disinfecion Drying phase: Use a linfree cloh or medical compressed air Page

TANr. 0 THA rasp handle 0/ Änd.Nr. 9 6 9 6 THA rasp handle Rasp Rasp adaper Handle par Clamping lever Borehole for cross pin Hammer plae Pushbuon Navigaion inerface 9 Fig. The THA rasp handle is used in hip arhroplasy procedures. holds proshesisspecific form rasps, which are driven in and ou during he preparaion of he femoral marrow caviy. Producspecific safey noes on he reprocessing procedure Risk o paiens! The produc mus only be cleaned mechanically! Always carry ou a funcion check prior o using he produc. DANGER nsering he rasp in he THA rasp handle Open clamping lever. Slide rasp ino rasp adaper. Close clamping lever. Make cerain ha pushbuon is no pressed when closing he clamping lever, see Fig.. Check ha rasp is firmly mouned. Driving he rasp in and ou Fig. Risk of injury and/or damage o he produc due o incorrec applicaion of he hammer! When driving he rasp in and ou, using a hammer, only hi he hammer plae of he THA rasp handle. Removing he rasp from he THA rasp handle Unlock clamping lever by simulaneously pressing clamping lever and pushbuon in he direcion of he arrow, and open i compleely, see Fig. Use cleaning and disinfecing agens approved for aluminum, plasics, and highgrade seel for insance, according o he manufacurer s insrucions. Observe specificaions regarding concenraion, emperaure and exposure Carry ou ulrasound cleaning: as an effecive mechanical supplemen o manual cleaning/disinfecion. as a precleaning procedure for producs wih encrused residues, in preparaion for mechanical cleaning/ disinfecion. as an inegraed mechanical suppor measure for mechanical cleaning/disinfecion. for addiional cleaning of producs wih residues lef afer mechanical cleaning/disinfecion. Manual precleaning wih ulrasound and brush, and subsequen mechanical alkaline cleaning and hermal disinfecion Chaper Mechanical cleaning/disinfecion wih manual precleaning and subchaper: Remove rasp from rasp adaper. Cleaning brush: e. g. TA006 0 ml disposable syringe Keep working ends open for cleaning. Chaper Manual precleaning wih ulrasound and brush Place insrumens in he ray wih heir hinges open. Page

nsrumen se: Excia T TANr. 06 0/ A Equipmen ray (example) B Equipmen wire baske (example) C Secion of sorage emplae shee (example for disassemblable produc, locus line poins o several pars in he ray) The insrumen se is used for he implanaion of primary hip replacemen prosheses. The insrumen se conains all necessary insrumens for he preparaion of he implan bed and for he funcion checks. Safe handling and preparaion Federal law resrics his device o sale by or on order of a physician! Ensure ha he insrumen se is operaed and used only by persons wih he requisie raining, knowledge, or experience. Read, follow, and keep he insrucions for use. Follow he operaing manuals of he respecive implan sysem. Use he insrumen se only in accordance wih is inended use, see. Remove he ranspor packaging and clean he new insrumen se, eiher manually or mechanically, prior o is iniial serilizaion. Sore any new or unused insrumens ses in a dry, clean, and safe place. Prior o each use, visually inspec he conens of he insrumen se for: loose, ben, broken, cracked, worn, or fracured componens. Do no use he insrumen if i is damaged or defecive. Se aside he insrumen immediaely if i is damaged. mmediaely replace defecive or damaged insrumens wih original spare pars. A Always carry ou a funcion check prior o using he produc. B C Preparaions a he place of use Risk of gloves geing caugh or damaged when handling he insrumens or ray! Risk of injury from sharp, poined or cuing insrumens! Handle he insrumens and ray wih care. /Assembling Disassemblable insrumens are labeled on he sorage emplae shee as corresponding aricles, see Fig. C. f applicable, rinse nonvisible surfaces preferably wih deionized waer, wih a disposable syringe for example. Remove any visible surgical residues o he exen possible wih a damp, linfree cloh. Transpor he dry produc in a sealed wase conainer for cleaning and disinfecion wihin 6 hours. Preparaion before cleaning Disassemble he disassemblable insrumens prior o cleaning, see /Assembling. Remove he sorage emplae shee from he ray. Follow he insrucions for use of he disassemblable insrumens. Producspecific safey noes on he reprocessing procedure Validaed reprocessing procedure General safey insrucions Adhere o naional sauory regulaions, naional and inernaional sandards and direcives, and local, clinical hygiene insrucions for serile processing. For paiens wih CreuzfeldJakob disease (CJD), suspeced CJD or possible varians of CJD, observe he relevan naional regulaions concerning he reprocessing of producs. Mechanical reprocessing should be favored over manual cleaning as i gives beer and more reliable resuls. Successful processing of his medical device can only be ensured if he processing mehod is firs validaed. The operaor/serile processing echnician is responsible for his. The recommended chemisry was used for validaion. f here is no final serilizaion, hen a virucidal disinfecan mus be used. For upodae informaion abou reprocessing and maerial compaibiliy, see also he Aesculap Exrane a hps://exrane.bbraun.com The validaed seam serilizaion procedure was carried ou in he Aesculap serile conainer sysem. General informaion Dried or affixed surgical residues can make cleaning more difficul or ineffecive and lead o corrosion. Therefore he ime inerval beween applicaion and processing should no exceed 6 h; also, neiher fixaing precleaning emperaures > C nor fixaing disinfecing agens (acive ingredien: aldehydes/alcohols) should be used. Excessive measures of neuralizing agens or basic cleaners may resul in a chemical aack and/or o fading and he laser marking becoming unreadable visually or by machine for sainless seel. Residues conaining chlorine or chlorides e.g. in surgical residues, medicines, saline soluions and in he service waer used for cleaning, disinfecion and serilizaion will cause corrosion damage (piing, sress corrosion) and resul in he desrucion of sainless seel producs. These mus be removed by rinsing horoughly wih demineralized waer and hen drying. Addiional drying, if necessary. Only process chemicals ha have been esed and approved (e.g. VAH or FDA approval or CE mark) and which are compaible wih he produc s maerials according o he chemical manufacurers recommendaions may be used for processing he produc. All he chemical manufacurer's applicaion specificaions mus be sricly observed. Failure o do so can resul in he following problems: Opical changes of maerials, e.g. fading or discoloraion of ianium or aluminum. For aluminum, he applicaion/process soluion only needs o be of ph > o cause visible surface changes. Maerial damage such as corrosion, cracks, fracuring, premaure aging or swelling. Do no use meal cleaning brushes or oher abrasives ha would damage he produc surfaces and could cause corrosion. Furher deailed advice on hygienically safe and maerial/valuepreserving reprocessing can be found a www.aki.org, link o Publicaions, Red Brochure Proper mainenance of insrumens. Use cleaning and disinfecing agens according o he manufacurer s insrucions which Ensure ha cleaning and disinfecing agens are approved for use on aluminum, plasics and sainless seel. do no aack sofeners (e.g. in silicone). Observe specificaions regarding concenraion, emperaure and exposure Do no exceed he maximum permied cleaning emperaure of C. Use suiable cleaning/disinfecing agens if he produc is pu away in a we condiion. To preven foam forma ion and reduced effeciveness of he process chemicals: Prior o mechanical cleaning and disinfecion, rinse he produc horoughly wih running waer. Carry ou ulrasound cleaning: as an effecive mechanical supplemen o manual cleaning/disinfecing. as a precleaning procedure for producs wih encrused residues, in preparaion for mechanical cleaning/disinfecing. as an inegraed mechanical suppor measure for mechanical cleaning/disinfecing. for addiional cleaning of producs wih residues lef afer mechanical cleaning/disinfecing. Manual cleaning and wipe disinfecion Chaper Manual cleaning/disinfecion and subchaper: Sorage emplae shee Manual precleaning wih ulrasound and brush and subsequen mechanical neural or mild alkaline cleaning and hermal disinfecing Drying phase: Use a linfree cloh or medical compressed air nsrumen se Preclean all producs manually wih a suiable cleaning brush. An Equipmen ray can be cleaned fully in he ulrasonic bah Chaper Mechanical cleaning/disinfecion wih manual precleaning and subchaper: Use a 0 ml disposable syringe. Remove he wire baske and lid of he ray, and place hese in he cleaning and disinfecing machine separaely. Chaper Manual cleaning and wipe disinfecing Chaper Manual precleaning wih ulrasound and brush Chaper Mechanical neural or mild alkaline Manual cleaning/disinfecion Prior o manual disinfecing, allow waer o drip off for a sufficien lengh of ime o preven diluion of he dis infecing soluion. Afer manual cleaning/disinfecion, check visible surfaces visually for residues. Repea he cleaning /disinfecion process if necessary. Page