GREATBATCH MEDICAL SA
OFFSET REAMER HANDLE Instructions for Assembly and Disassembly to allow Cleaning and Sterilisation
2 Pages
![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 : orthoeurope@greatbatchmedical.com 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 1/2](https://images.bioclinicalservices.com.au/rl1h7wbuxiqtlspuucowpvce8aeu/320w/GREATBATCH%20MEDICAL%20SA%20-%20OFFSET%20REAMER%20HANDLE%20Instructions%20for%20Assembly%20and%20Disassembly%20to%20allow%20Cleaning%20and%20Sterilisation%20-%202010-05%20-%20Rev%205.png)
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Page 1
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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Manufacturer
IMPORTANT NOTICE When reaming bone it is essential that a firm grip on the handle is maintained to minimise 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
ASSEMBLY Each element of the instrument forms a unique set and in no instance should the parts of one be mixed with those from another reamer handle. 1. Place the interior drive chain into one half Step 2
2. Place the other half on top Step 1 Select all of the sterilized pieces Push and twist the collar to lock the two halves together
Step 4
Step 3
Step 5
Push and twist
Step 6
Introduce the interior
Step 7
Check correct assembly and the required handle orientation
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
Lit. No. 2152-e
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