Precautionary Statement ( )

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1 Precautinary Statement ( ) Bimet Orthpedics, Inc P.O. Bx 587 Date: 05/06 56 East Bell Drive Warsaw, Indiana USA Recmmendatins fr the Care and Handling Bimet Premier II Acetabular Driver Handle and EZ Clean Acetabular Reamer Surgical Instruments and Instrument Cases DESCRIPTION Bimet instruments and instrument cases are generally cmpsed f aluminum, stainless steel, and/r plymeric materials. The cases may be multi-layered with varius inserts t hld surgical instrumentatin in place during handling and strage. The inserts may cnsist f trays, hlders, and silicne mats. The instrument cases are perfrated t allw steam t penetrate these varius materials and cmpnents. The instrument cases will allw sterilizatin f the cntents t ccur in a steam autclave utilizing a sterilizatin and drying cycle that has been validated by the user fr the equipment and prcedures emplyed at the user facility. Instrument cases d nt prvide a sterile barrier and must be used in cnjunctin with a sterilizatin wrap t maintain sterility. Materials Aluminum Stainless Steel Plymeric Materials DISCLAIMER Bimet instrument cases are intended t prtect instrumentatin and facilitate the sterilizatin prcess by allwing steam penetratin and drying. Bimet has verified thrugh labratry testing that ur instrument cases are suitable fr the specific sterilizatin methds and cycles fr which they have been tested. Health care persnnel bear the ultimate respnsibility fr ensuring that any packaging methd r material, including a reusable rigid cntainer system, is suitable fr use in sterilizatin prcessing and sterility maintenance in a particular health care facility. Testing shuld be cnducted in the health care facility t ensure that cnditins essential t sterilizatin can be achieved. Bimet des nt accept respnsibility r liability fr any claims r cmplaints arising frm r related t a lack f cleanliness r sterility f any medical devices supplied by Bimet that shuld have been prperly cleaned and/r sterilized by the end user prir t use. CLEANING AND DECONTAMINATION Full Assembly Remval f Grss Cntaminatin n the full assembly. The effectiveness f subsequent decntaminatin prcesses

2 depends n prir remval f grss sil as it may be impaired by dried r cagulated prtein. Grss sil shuld be remved under running water using a mechanical aid such as a brush with rigid nyln bristles. Care shuld be taken t avid splashing and generating aersls by hlding instruments belw the surface f the water in a sink int which water is running and cntinuusly draining. Instruments shuld nt be held under a running tap, as this is likely t result in splashing. Operatives shuld wear prtective equipment including glves and gggles. Care shuld be taken t avid penetrating r cutting injuries. Disassembly T remve the actetabular reamer, pull back the thumb trigger away frm the acetabular reamer end. Rtate the acetabular reamer t remve. T remve the tissue prtectr cllar, depress the plunger pin n the shaft f the handle. Slide the tissue prtectr cllar ver the plunger pin sliding the tissue prtectr cllar past the cnnecting end fr the active pwer surce t remve. The three (3) cmpnents may be cleaned per the recmmendatins within this instructin fr use listed belw. Washing/Disinfecting- It is recmmended that the disassembled instruments be decntaminated using an autmatic washer-disinfectin unit utilizing thermal disinfectin. This shuld preferably be f the ultrasnic r cntinuus tunnel prcess type. The cabinet type is an acceptable alternative if a cntinuus prcess machine is nt available. (Typical initial cleaning temperature is at r belw 95 F (35 C), fllwed by a ht water disinfectant rinse where the surface temperature f the instruments shuld reach a minimum temperature f 160 F (71 C) fr a minimum f 3 minutes, 176 F (80 C) fr a minimum f 1 minute, r 194 F (90 C) fr 1 secnd.) Cmpatible detergents and rinse aids may be used as recmmended by the manufacturer f the washer-disinfectin unit. These detergents and/r rinse aids, hwever, shuld be f neutral r near neutral ph. Excessively acidic r alkaline slutins may crrde aluminum instruments. PREPARATION AND ASSEMBLY After cleaning/disinfecting, the disassembled instruments shuld be reassembled and placed in their prper lcatins in the instrument cases. Assemble the tissue prtectr cllar past the cnnecting end fr the active pwer surce tward the acetabular reamer end. Nte that the large diameter f the tissue prtectr cllar must g tward the acetabular reamer end. Depress the pin n shaft handle and slide ver t cmplete tissue prtectr cllar assembly. Once cleaned the handle assembly and individual acetabular reamers may be placed int the instrumentatin case fr sterilizatin prcessing.

3 CARE AND HANDLING OF INSTRUMENTS 1. General. Surgical instruments and instrument cases are susceptible t damage fr a variety f reasns including prlnged use, misuse, and rugh r imprper handling. Care must be taken t avid cmprmising their exacting perfrmance. T minimize damage and risk f injury, the fllwing shuld be dne: Inspect the instrument case and instruments fr damage upn receipt and after each use and cleaning. Incmpletely cleaned instruments shuld be re-cleaned. Instruments in need f repair shuld be set aside fr repair service r returned t Bimet. Only use an instrument fr its intended purpse. When handling sharp instruments use extreme cautin t avid injury. Cnsult with an infectin cntrl practitiner t develp and verify safety prcedures apprpriate fr all levels f direct instrument cntact. 2. General Cleaning. Clean instruments prir t initial sterilizatin and as sn as pssible after use. D nt allw bld r debris t dry n the instruments. If cleaning must be delayed, place grups f instruments in a cvered cntainer with apprpriate detergent r enzymatic slutin t delay drying. Wash all instruments whether r nt they were used r inadvertently came int cntact with bld r saline slutin. 3. Ultrasnic Cleaners can be used with ht water per manufacturer's recmmended temperature (usually ºF r 32-60ºC) and specially frmulated detergents. Fllw manufacturer's recmmendatins fr prper cleaning slutin frmulated specifically fr ultrasnic cleaners. Be aware that lading patterns, instrument cassettes, water temperature, and ther external factrs may change the effectiveness f the equipment. 4. Washer-Decntaminatin Equipment will wash and decntaminate instruments. Cmplete remval f sil frm crevices and serratins depends n instrument cnstructin, expsure time, pressure f delivered slutin, and ph f the detergent slutin, and thus may require prir brushing. Be familiar with equipment manufacturers' use and peratin instructins. Be aware that lading, detergent, water temperature, and ther external factrs may change the effectiveness f the equipment. RESPONSIBILITIES OF THE USER General. Health care persnnel bear the ultimate respnsibility fr ensuring that any packaging methd r material is suitable fr use in sterilizatin prcessing and sterility maintenance. Cleaning/Decntaminatin. The health care facility is respnsible t ensure that cnditins essential t safe handling and decntaminatin can be achieved. ANSI/AAMI ST35 Safe Handling and Bilgical Cntaminatin f Reusable Medical Devices in Health Care Facilities and in Nnclinical Settings prvides guidelines fr design and persnnel cnsideratins, immediate handling f cntaminated items and transprtatin, decntaminatin prcesses, servicing repair, and prcess perfrmance. Sterility. Users shuld cnduct testing in the health care facility t ensure that cnditins essential t sterilizatin can be achieved and that specific cnfiguratin f the cntainer cntents is acceptable fr the sterilizatin prcess and fr the requirements at the pint f use. ANSI/AAMI ST33 Guidelines fr the Selectin and Use f Reusable Rigid Cntainer Systems fr Ethylene Oxide Sterilizatin and Steam Sterilizatin in Health Care Facilities cvers the selectin and use f reusable rigid sterilizatin cntainer systems. Guidelines are prvided by this standard fr cleaning and decntaminatin, preparatin and assembly, sterilizer lading and unlading, matching the cntainer system t the apprpriate sterilizatin cycle, quality assurance, sterile strage, transprt, and aseptic use. WARNINGS AND PRECAUTIONS Unless therwise indicated, instrument sets are NOT sterile and must be thrughly cleaned and sterilized prir t use. Instruments shuld NOT be flash-autclaved inside the instrument case. Flash-autclaving f individual instruments shuld be avided.

4 Unwrapped instrument cases DO NOT maintain sterility. STORAGE AND SHELF LIFE Instrument cases that have been prcessed and wrapped t maintain sterility shuld be stred in a manner t avid extremes in temperature, misture, and/r ther cntaminatin. Care must be exercised in handling f wrapped cases t prevent damage t the sterile barrier. The health care facility shuld establish a shelf life fr wrapped instrument cases based upn the type f sterile wrap used and the recmmendatins f the sterile wrap manufacturer. Regardless f whether wven r nn-wven materials, puches, r cntainer systems are used as the packaging methd, the user must be aware that maintenance f sterility is event-related and that the prbability f ccurrence f a cntaminating event increases ver time, with handling, and whether wven r nn-wven materials, puches, r cntainer systems are used as the packaging methd. STERILITY Unless therwise indicated, instruments are NOT STERILE and must be thrughly cleaned and sterilized prir t each use. Bimet instruments can be steam autclaved, and repeated autclaving will nt adversely affect them, unless therwise indicated in the labeling. If yu have any prblems when using Bimet instruments r instrument cases, please bring this t Bimet's r the Bimet distributr's attentin when yu return them (Instruments returned t Bimet r its distributrs shuld be cleaned and sterilized prir t shipment. ANSI/AAMI ST35 Safe Handling and Bilgical Cntaminatin f Reusable Medical Devices in Health Care Facilities and in Nnclinical Settings prvides guidelines fr return, r cntact Bimet r yur distributr fr further instructin.). Unless supplied sterile, instruments must be thrughly cleaned and sterilized prir t surgical use. Set frth belw is a recmmended minimum cycle fr steam sterilizatin that has been validated by Bimet under labratry cnditins. Individual users must validate the cleaning and autclaving prcedures used n-site, including the n-site validatin f the recmmended minimum cycle parameters described belw. Surgical instruments may be autclaved using a full cycle. Instruments that have been used in a surgical envirnment shuld be thrughly cleaned prir t autclaving. Use f ANSI/AAMI ST46 Steam Sterilizatin and Sterility Assurance in Health Care Facilities is recmmended. GRAVITY DISPLACEMENT STERILIZER (Full Cycle) 270º - 275º F (132º - 135º C) - Wrapped r unwrapped 12 minutes expsure time - 8 minutes drying time. PRE-VACUUMED STERILIZER (HI-VAC) 270º º F (132º - 135º C) - Wrapped r unwrapped 5 minutes expsure time - 8 minutes drying time. Since Bimet is nt familiar with individual hspital handling prcedures, cleaning methds, biburden levels, and ther cnditins, Bimet assumes n respnsibility fr sterilizatin f prduct by a hspital even if the general abve guidelines are fllwed. Cmments regarding Bimet devices r instruments can be directed t Attn: Regulatry Dept., Bimet, Inc., P.O. Bx 587, Warsaw, IN USA, FAX: Authrized Representative: Bimet U.K., Ltd. Watertn Industrial Estates, Bridgend, Suth Wales

5 CF31 3XA, U.K. CE 0086 CLEANING AND STERILIZATION METHODS Bimet Rigid Instrument Cases - Suitable fr Steam AutclavingAluminum, Stainless Steel, Radel (registered trademark f Amc) Prcessing Steps Remval f grss cntaminatin & disassembly Washing & Disinfecting Sterilizatin Suggested Methd By hand submerged in water with cntinuus flw with mechanical aid (e.g. brush) wearing prtective glves & gggles Disassemble instruments int individual parts Autmatic washer-disinfectin unit utilizing thermal disinfectin (ultrasnic r cntinuus tunnel prcess preferable) - Temperatures, cycles & disinfectant type used as instructed by manufacturer f washer-disinfectin unit Steam autclave Gravity Displacement Sterilizer (Full Cycle) 270º - 275º F (132º - 135º C) Wrapped r unwrapped 12 minutes expsure time - 8 minutes drying time Steam Autclave Cycle Parameters* Pre-Vacuumed Sterilizer (HI-VAC) 270º - 275º F (132º - 135º C) - Wrapped r unwrapped 5 minutes expsure time - 8 minutes drying time *Validated by Bimet under labratry cnditins, hwever, these cycles must be revalidated by the end- user t ensure that sterility can be achieved n site. When handling sharp instruments, use extreme cautin t avid injury. Cnsult with an infectin cntrl practitiner t develp and verify safety prcedures apprpriate fr all levels f direct instrument cntact. Precautins Unless therwise indicated, instrument sets are NOT Sterile and must be thrughly cleaned and sterilized prir t each use. Instruments shuld NOT be flash-autclaved inside the instrument case. Flash-autclaving f individual instruments shuld be avided, whenever pssible. Unwrapped instrument cases DO NOT maintain sterility.

Technical Data Sheet EW1 Top coats

Technical Data Sheet EW1 Top coats Tp cats Descriptin Wanda PU 2K HS is a single layer Plyurethane tpcat which ffers gd pacity, high glss, quick dry and gd weather resistance. It is suitable fr repair r verall re-sprays. 4 Wanda PU 2K HS