Table of Contents
Advertisement
Quick Links
Orthofix Inc.
3451 Plano Parkway
Lewisville, Texas 75056-9453 U.S.A.
1-214-937-3199
1-888-298-5700
www.orthofix.com
OSI-CustomerService@Orthofix.com
M6-C™ Artificial Cervical Disc Surgical Instruments
PK 0248 Rev 02
CARE AND HANDLING INSTRUCTIONS
Spinal Kinetics LLC, an Orthofix Company
501 Mercury Drive
Sunnyvale, CA 94085 USA
1-888-298-5700
English
EN
2-7
Advertisement
Table of Contents
Related Manuals for Orthofix M6-C
Summary of Contents for Orthofix M6-C
- Page 1 CARE AND HANDLING INSTRUCTIONS Spinal Kinetics LLC, an Orthofix Company Orthofix Inc. 501 Mercury Drive 3451 Plano Parkway Sunnyvale, CA 94085 USA Lewisville, Texas 75056-9453 U.S.A. 1-888-298-5700 1-214-937-3199 1-888-298-5700 www.orthofix.com OSI-CustomerService@Orthofix.com M6-C™ Artificial Cervical Disc Surgical Instruments English PK 0248 Rev 02...
- Page 2 Additionally, there is a tamp to independently adjust the posterior position of the M6-C endplates, a removal tool to remove the disc from the disc space, and general surgical instruments to assist in the distraction and mobilization of the disc space. The instruments are composed primarily of surgical stainless steel coated with ME-92 coating to increase corrosion resistance, with some instrument handles also featuring aluminum and Radel materials.
- Page 3 M6-C Operative Technique Manual. DISCLAIMER The M6-C Instrument Tray is intended to protect the M6-C Surgical Instruments and facilitate the sterilization process by allowing steam penetration and drying. Laboratory testing has verified that the instrument tray is suitable for the specific sterilization methods and cycles for which it has been tested. Health care personnel...
- Page 4 M6-C™ Artificial Cervical Disc Surgical Instruments Care and Handling Instructions WARNING: • Only trained personnel should clean and sterilize instruments as described in these Instructions for Use. Use appropriate personal protection equipment when handling contaminated instruments. • Instruments should be dried after cleaning and after any exposure to water.
- Page 5 Care and Handling Instructions M6-C™ Artificial Cervical Disc Surgical Instruments Manual Cleaning Process: • Prior to cleaning, disassemble any instrument capable of being disassembled. • Rinse the instruments under running tap water. Use a syringe to flush lumens and hard to reach areas. A wire guide and/or pipe cleaner should be used to aid in cleaning lumens and other hard to reach areas.
- Page 6 When sterilizing multiple instruments in an autoclave cycle, ensure that the sterilizer’s maximum load is not exceeded. Do not stack another instrument tray on top of the M6-C Instrument Tray during the sterilization process. The following sterilization cycle parameters were validated under laboratory conditions; however, these cycles must be re-validated by the end user to ensure that sterility can be achieved on site.
- Page 7 Orthofix should be notified immediately by telephone or written correspondence. When filing a complaint, please provide the device name and serial number, lot number, your name and address, and the nature of the complaint.
- Page 8 SPINAL KINETICS, MOTION FOR LIFE, ORTHOFIX, M6 and associated logos are trademarks or registered trademarks of Orthofix Medical Inc. or its affiliates in the U.S. and other countries. Patents: Orthofix.com PK 0248 Rev 02...
Need help?
Do you have a question about the M6-C and is the answer not in the manual?
Questions and answers