OFFSET REAMER HANDLE Instructions for Assembly and Disassembly to allow Cleaning and Sterilisation

Manufacturer

IMPORTANT NOTICE When reaming bone it is essential that a firm grip on the handle is maintained to minimize any risk that the reamer cuts eccentrically.

GREATBATCH MEDICAL SA 7, L'Echelette 2534 Orvin Switzerland Tél. : +41 (0)32 358 01 11 Fax : +41 (0)32 358 01 00 e-mail : [email protected]

0459

NON STERILE

OFFSET REAMER HANDLE : INSTRUCTIONS FOR ASSEMBLY AND DISASSEMBLY TO ALLOW CLEANING AND STERILISATION GREATBATCH MEDICAL instruments are not supplied sterile and should be cleaned and sterilised before first use. Instruments should be disassembled as shown for cleaning and sterilisation. CLEANING : The instruments should be soaked, cleaned and rinsed in purified water. Mild detergent, neutral pH solutions may be used, but no strong acid, strong alkali or fat based detergent should be used. A soft bristle brush may be used to clean hard to reach recesses. -6

STERILISATION : These parts have been validated to achieve a 10 sterility assurance level using steam sterilisation with a prevacuum cycle at 134°C for 3 minutes. It is important that process parameters are validated for each facility's individual type of equipment and load configuration. Each cleaning and sterilisation facility is responsible for the procedures of cleaning and inspection to ensure that the parts are processed in a manner to achieve adequate steam penetration and drying. EtO, gas plasma and other cold techniques should not be used.

DISASSEMBLY Step 3

Extract the interior part

Step 2 Step 1

Push and twist

Open the two halves Push and twist Step 4

Step 5 Step 6 Sterilization Step 7

Clean all the pieces before placing on the tray for sterilisation

Step 8 Clean all corners and recesses

D 3.3.1.31 rev 5 - Approuvé par signature sur la fiche de vie n° 2010.159 - Document effectif depuis le 04.05.2010

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