Arthrex
Shoulder Suspension System Cleaning and Sterilization Directions
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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). For 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. Prepare the detergent Neodisher® Mediclean Forte at ¼ oz/per gallon of lukewarm tap water in an ultrasonic bath. 2. Fully immerse the devices in the prepared detergent and sonicate for 10 minutes. 3. Remove the devices from the detergent and transfer them into the washer for processing. 4. The washer parameters that have been validated are shown below in Table 1. The motor speed should be set to high.
Manufactured For: Arthrex, Inc. 1370 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.P. 14 Z.I. 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
Recirculation time (minutes) 3:00 10:00
Temperature Cold tap water 65.5°C
Rinse 1 Rinse 2 Thermal Disinfection Drying
3:00 3:00 5:00 6:00
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. 1370 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.P. 14 Z.I. 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