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Care and Handling Instructions

M6-C™ Artificial Cervical Disc Surgical Instruments

PRODUCT COMPLAINTS

Any health care professional (e.g., customer or user of this system), who has complaints or who has experienced

any dissatisfaction in the product quality, identity, durability, reliability, safety, effectiveness and/or performance,

should notify Orthofix. Further, if the device (implant or instruments) ever “malfunctions,” (i.e. does not meet

any of its performance specifications or otherwise does not perform as intended) or may have caused or

contributed to the death or serious injury of a patient, 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. Complaints may also be reported directly to

Содержание M6-C

Страница 1: ...IONS PK 0248 Rev 02 English 2 7 EN 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 Spinal Kinetics LLC...

Страница 2: ...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...

Страница 3: ...ents before each use After cleaning sterilize as directed prior to use As soon as possible after surgery instruments should be cleaned and sterilized Clean the instruments per the instructions below S...

Страница 4: ...sinfectors Part 1 General requirements terms and definitions and tests provide relevant guidelines Sterility Users should conduct testing in the health care facility to ensure that conditions essentia...

Страница 5: ...eutral detergent solution and rinse them with RO DI water for a minimum of one minute Use a syringe to flush lumens and hard to reach areas Actuate any knobs clamps or joints while performing this pro...

Страница 6: ...tion 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 Instruments should be placed...

Страница 7: ...thofix Further if the device implant or instruments ever malfunctions i e does not meet any of its performance specifications or otherwise does not perform as intended or may have caused or contribute...

Страница 8: ...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...