Arthrex

S3 Lateral Traction Sling Connector

D-720771-A1 AR-1650 Shoulder Suspension System Cleaning and Sterilization Directions Feb 2016

14 Pages

Cleaning and Sterilization Directions for Use for Reusable Connection Devices for Use with AR-1650 Shoulder Suspension System  AR-1650-02 Arm Sleeve Connector  AR-1650-03 Lateral Traction Sleeve Connector  The Cleaning and Sterilization directions apply to the S3 Arm Sleeve Connector (AR-1650-02) and the S3 Lateral Traction Sling Connector (AR-1650-03)... or further directions for use regarding the Arthrex® Shoulder Suspension System please refer to the S3 System IFU (D-720764)... WARNING: Failure to properly sterilize device could cause exposure to contaminant... Automatic Cleaning Procedure AR-1650-02 & AR-1650-03 1... repare the detergent Neodisher® Mediclean Forte at ¼ oz/per gallon of lukewarm tap water in an ultrasonic bath... ully immerse the devices in the prepared detergent and sonicate for 10 minutes... emove the devices from the detergent and transfer them into the washer for processing... he washer parameters that have been validated are shown below in Table 1... he motor speed should be set to high... Manufactured For: Arthrex, Inc... 370 Creekside Blvd Naples, FL 34108, USA 1-(800) 934-4404  Arthrex GmbH Erwin-Hielscher-Strasse 9 81249 München, Germany +49 89 909005-0  Allen Medical Systems 100 Discovery Way Acton, MA 01720 (978) 266-5401  Hill Rom SAS B...  14 Z...  du Talhouet 56330 Pluvigner, France Tel... 33 (0) 2 97 50 92 12 Fax... 33 (0) 2 97 50 92 00  D-720771-A1 08 FEB 2016   Table 1: Validated Washer Parameters for the AR-1650-02 & AR-1650-03... Phase Pre-Wash 1 Wash 1 Rinse 1 Rinse 2 Thermal Disinfection Drying  Recirculation time (minutes) 3:00 10:00 3:00 3:00 5:00 6:00  Temperature Cold tap water 65... C 50°C 50°C 90°C 115°C  Detergent type and Concentration N/A Neodisher® Mediclean Forte ¼ oz/gallon N/A N/A N/A N/A  Steam Sterilization for AR-1650-02 & AR-1650-03  Sterilizer Type: Preconditioning Pulses: Minimum Temperature: Full Cycle Time: Minimum Dry Time: Cool-Down Time:  Prevacuum 4 132°C 4 minutes 30 minutes 30 Minutes outside of chamber on a wire rack  Sterilizer Type: Minimum Temperature: Full Cycle Time: Minimum Dry Time: Cool-Down Time:  Gravity 132°C 15 Minutes 50 Minutes 30 minutes outside of chamber on a wire rack  Manufactured For: Arthrex, Inc... 370 Creekside Blvd Naples, FL 34108, USA 1-(800) 934-4404  Arthrex GmbH Erwin-Hielscher-Strasse 9 81249 München, Germany +49 89 909005-0  Allen Medical Systems 100 Discovery Way Acton, MA 01720 (978) 266-5401  Hill Rom SAS B...  14 Z...  du Talhouet 56330 Pluvigner, France Tel... 33 (0) 2 97 50 92 12 Fax... 33 (0) 2 97 50 92 00  D-720771-A1 08 FEB 2016
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