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Care and Handling Instructions
M6-C™ Artificial Cervical Disc Surgical Instruments
INDICATIONS FOR USE
For M6-C™ Artificial Cervical Disc Indications, Contraindications, Warnings and Precautions, and other important
medical information, please refer to the M6-C Instructions for Use available at www.orthofix.com/ifu, and the
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
bear the ultimate responsibility for ensuring that any packaging method or material, including a reusable
rigid container system, is suitable for use in sterilization processing and sterility maintenance in a particular
health care facility. Testing should be conducted in the health care facility to ensure that conditions essential to
sterilization can be achieved. Orthofix does not accept responsibility or liability arising from a lack of cleanliness
or sterility of any medical devices supplied by Orthofix that should have been properly cleaned and/or sterilized
by the end user prior to use.
RECOMMENDATIONS
•
The instruments are provided non-sterile. Clean instruments 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. Strictly follow the dosage, temperature, exposure time,
and material compatibility specifications for the cleaning agent.
•
Sterilize the instruments using the steam sterilizer operating conditions below.
•
Stainless steel instruments can become stained or corroded if the cleaning and sterilization instructions
are not followed. If excessive staining is observed use demineralized water for cleaning and sterilization.
Staining may be eliminated by scrubbing the device following standard cleaning procedures. Instruments
with corrosion should be removed from use.
•
Repeated reprocessing of the instruments has minimal effect. End of life is normally determined by wear
and damage due to use.
•
After each use inspect all instruments for any damage. Discard and replace instruments as necessary.
•
After cleaning and sterilization, verify functionality prior to use.
CAUTION:
•
If sterilizing for the first time, remove all vinyl caps and packing foam prior to autoclaving.
•
Soak or rinse instruments immediately after use. To avoid risk of corrosion or staining, DO NOT exceed
15 minutes soaking time.
•
Do not use Glutaraldehyde, Chlorine, or Ammonium for soaking; this may cause damage to the
instrument finish.
•
Do not use dry heat sterilization, as this may damage the instrument finish.
•
Only sterilize clean instruments; sterilization is only effective on clean items.
•
Store instruments in a clean, dry area.
