Orthofix M6-C Care And Handling Instructions Download Page 5

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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. 

Actuate any knobs, clamps, or joints while performing this process.

• 

Prepare an enzymatic cleaning solution, such as Enzol®, per the manufacturer’s instructions.

• 

Fully immerse the instruments in the prepared enzymatic cleaning solution and allow them to soak for a 

minimum of one minute.

• 

After the soak, use a soft bristle brush to thoroughly clean any crevices or other difficult to clean areas of 

the instruments. Flush lumens and small spaces with a syringe. A wire guide and/or pipe cleaner should be 

used to aid in cleaning lumens and other hard to reach areas. Actuate any knobs, clamps, or joints while 

performing this process.

• 

Remove the instruments from the enzymatic cleaning solution and rinse them with reverse osmosis or de-

ionized (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 process.

• 

Prepare a neutral detergent, such as ValSure® Neutral Detergent, according to the manufacturer’s 

recommendations using warm tap water in an ultrasonic bath.

• 

Fully immerse the instruments into the sonication bath and sonicate for two minutes.

• 

Remove the instruments from the neutral 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 process.

• 

Dry the instruments using a clean, lint-free cloth to avoid damage to the surface. Pressurized air (20psi) may 

be used to assist in drying.

• 

Visually inspect the surgical instruments for cleanliness. If instruments are not visually clean, then repeat the 

entire cleaning process.

Automated 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. 

Actuate any knobs, clamps, or joints while performing this process.

• 

Prepare an enzymatic cleaning solution, such as Enzol®, per the manufacturer’s instructions.

• 

Fully immerse the instruments in the prepared enzymatic cleaning solution and allow them to soak for a 

minimum of one minute.

• 

After the soak, use a soft bristle brush to thoroughly clean any crevices or other difficult to clean areas of 

the instruments. Flush lumens and small spaces with a syringe. A wire guide and/or pipe cleaner should be 

used to aid in cleaning lumens and other hard to reach areas. Actuate any knobs, clamps, or joints while 

performing this process.

• 

Remove the instruments from the enzymatic cleaning solution and rinse them with reverse osmosis or de-

ionized (RO/DI) water for a minimum of one minute. Flush lumens and small spaces with a syringe. Actuate 

any knobs, clamps, or joints while performing this process.

• 

Place the instruments into the washer for processing.

• 

Run the validated cycle parameters below.

Summary of Contents for M6-C

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

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