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Summary of Contents for Arbutus Medical DrillCover Hex System
- Page 1 DrillCover Hex System INSTRUCTIONS FOR USE...
- Page 2 Arbutus Medical 560 - 828 West 10th Ave Vancouver, BC Canada V5Z 1L8 Advancing Safe Surgery Together Email: service@arbutusmedical.ca Phone: +1-778-296-2577 Website: www.arbutusmedical.ca Do not modify this equipment. Do not service the device. Service is not intended to be performed by the operator.
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Page 3: Table Of Contents
CONTENTS 1. Warnings 2. Intended Use and Technical Description 3. Inventory of Materials 4. Sterile Unloading Procedure 5. Reprocessing 6. Disposal 7. Storage DrillCover Hex System: Instructions For Use... -
Page 4: Warnings
Reorient or relocate the affected equipment. There is no significant risk of reciprocal interference posed by the device during specific investigations or treatments. Do not oil or lubricate unless with biocompatible lubricant. For more information regarding these warnings, contact Arbutus Medical. Arbutus Medical... -
Page 5: Intended Use And Technical Description
This instructions for use gives users essential information to prepare the device for use and to reprocess for re-use. The DrillCover Hex System is a battery powered drilling system equipped with a standard hex quick-change drive and reusable aseptic enclosure. The device is meant for use by orthopaedic surgeons. -
Page 6: Inventory Of Materials
3. INVENTORY OF MATERIALS Drill Battery Charger Spare Battery Nose piece DrillCover Linen Chuck Adapter Accepts drill bits Ø 0.5 - 7.4mm Chuck Key Arbutus Medical... -
Page 7: Sterile Unloading Procedure
Hex System. Two team members are required for loading. Observe when a sterile or nonsterile team member should perform each step. Arbutus Medical recommends practicing the sterile loading procedure before clinical use. Complete the loading procedure before the sterile team member is contaminated by biohazard during the procedure. - Page 8 Try re-charging the battery again or use a different charged battery. If the drill still does not operate, contact Arbutus Medical. 2. You may terminate operation of the drill by releasing the trigger. 3. Ensure toggle switch is set to forward, not reverse.
- Page 9 Ensure that the sterile team member is prepared to accept the drill without dropping the sterile Cover. DrillCover Hex System: Instructions For Use...
- Page 10 Sterile Team Member Do not let quick-release chuck come out of nose opening. 1. Keep nose piece facing up. 2. Pull back excess fabric so the quick-release chuck can be seen but it does not come out of the opening. Arbutus Medical...
- Page 11 8pH) on the linen, buckles, chuck piece and into the chuck. Enzyme concentration should follow manufacturer recommendations. Do not use a saline solution for pre-cleaning as it will damage the device. 4. Disassemble the DrillCover linen. DrillCover Hex System: Instructions For Use...
- Page 12 Nonsterile Team Member 10. Remove drill battery and click into charger. A light indicates charging. The battery takes approximately 30 minutes to charge. You many store battery in charger. Arbutus Medical...
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Page 13: Reprocessing
1. Immerse chuck key, chuck adapter and linen into a freshly prepared solution of neutral enzymatic solution designed for surgical instruments (ex. Medzyme) and allow to soak for 5 minutes. DrillCover Hex System: Instructions For Use... - Page 14 Do not wring or twist device. Hang cover in drying cabinet, or on a drying rack in front of a fan. Autoclaving the cover while wet will reduce its expected lifetime. Arbutus Medical...
- Page 15 4. If linen passes inspection, record each use on the tracking grid located on the inside of the linen, by marking one square using a laundry pen. If linen fails inspection, remove it from clinical use. DrillCover Hex System: Instructions For Use...
- Page 16 10 in sterile linens are sufficient for the chuck adapter and key. Ensure chuck is in a fully-open position. 3. Place packages in autoclave and run the autoclave using these sterilization settings: TEMPERATURE 121ºC EXPOSURE TIME 30 minutes DRY TIME 60 minutes Arbutus Medical...
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Page 17: Disposal
DrillCover linen and hardware can be disposed with other biohazardous waste or it can be sterilized and disposed as regular waste. Drill can be disposed of in common electronics recycling. 7. STORAGE Store device in a cool, dry place to maximize the lifetime of the product. DrillCover Hex System: Instructions For Use... - Page 18 ARBUTUS 560 - 828 West 10th Ave Website: www.arbutusmedical.ca Vancouver BC Canada Email: service@arbutusmedical.ca MEDICAL V5Z 1M9 Telephone: (+1) 778-296-2577...
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