Orthofix M6-C Care And Handling Instructions

CARE AND HANDLING INSTRUCTIONS

Orthofix Inc.
3451 Plano Park way
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, an Orthofix Company
501 Mercury Drive
Sunnyvale, CA 94085 USA
1-888-298-5700

M6-C™ Artificial Cervical Disc Surgical Instruments

English 2-7

EN

PK 0248 Rev 02

M6-C™ Artificial Cervical Disc Surgical Instruments Care and Handling Instructions

DEVICE DESCRIPTION

The surgical implantation of the M6-C Articial Cervical Disc requires specic surgical instruments including: a
footprint template and a trial to determine the appropriate size and position of the implant; a n cutter to create
tracks in the superior and inferior vertebral endplates; and an implant inserter to place the disc into the desired
position to aid in and ensure correct placement within the intervertebral space. 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. Surgical instruments
are provided non-sterile and are intended to be reusable.

The instruments provided in the kit include Footprint Templates, Trials, Inserters, Fin Cutters, a Tamp, Removal
Tools, an Intervertebral Distractor, a Paddle Distractor, a Distractor Spacer, a Slide Hammer, a Retainer, Retainer
Pins and Locking Nuts. All instruments are made of surgical stainless steels per ASTM F899-12b, aluminum
(mallet handle), and Radel (pin driver handle).

The M6-C Instrument Tray is composed of stainless steel, Nylon, Radel Plastic, and Silicone. The tray is multi­layered with various inserts to hold surgical instrumentation in place during handling and storage. The
instrument tray is perforated to allow steam to penetrate which will allow sterilization of the contents to occur
in a steam autoclave.

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Care and Handling Instructions M6-C™ Artificial Cervical Disc Surgical Instruments

INDICATIONS FOR USE

For M6-C™ Articial Cervical Disc Indications, Contraindications, Warnings and Precautions, and other important
medical information, please refer to the M6-C Instructions for Use available at www.orthox.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 veried that the instrument tray is
suitable for the specic 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. Orthox does not accept responsibility or liability arising from a lack of cleanliness
or sterility of any medical devices supplied by Orthox 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 specications 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 eect. 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 rst 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 nish.

• Do not use dry heat sterilization, as this may damage the instrument nish.

• Only sterilize clean instruments; sterilization is only eective on clean items.

• Store instruments in a clean, dry area.

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