User Manual Q&AAnswer
Jan 29, 2025 - 10:16 PM
The ORTHOFIX M6-C Artificial Cervical Disc Surgical Instruments should be cleaned and sterilized before each use. Here is the recommended cleaning and sterilization process:
1. Manual Cleaning Process:
- Disassemble any instrument that can be disassembled.
- Rinse the instruments under running tap water, using a syringe to flush lumens and hard-to-reach areas. Actuate any knobs, clamps, or joints during this process.
- Prepare an enzymatic cleaning solution, such as Enzol®, according to the manufacturer's instructions.
- Fully immerse the instruments in the enzymatic cleaning solution and allow them to soak for at least one minute.
- Use a soft bristle brush to thoroughly clean any crevices or difficult-to-clean areas. Flush lumens and small spaces with a syringe. Actuate any knobs, clamps, or joints during this process.
- Rinse the instruments with reverse osmosis or de-ionized (RO/DI) water for at least one minute. Flush lumens and hard-to-reach areas with a syringe. Actuate any knobs, clamps, or joints during 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.
- Rinse the instruments with RO/DI water for at least one minute. Flush lumens and hard-to-reach areas with a syringe. Actuate any knobs, clamps, or joints during this process.
- Dry the instruments using a clean, lint-free cloth or pressurized air (20psi) to avoid damage to the surface.
- Visually inspect the instruments for cleanliness. If they are not visually clean, repeat the entire cleaning process.
2. Automated Cleaning Process:
- Follow the same steps as the manual cleaning process, but instead of manually cleaning, place the instruments into an automated washer for processing.
- Run a validated cycle with the following parameters:
- Pre-wash 1: 2 minutes, cold tap water
- Enzyme Wash: 2 minutes, hot tap water with Enzol® (1 oz/gallon)
- Wash 1: 2 minutes, 65.5°C with ValSure® Neutral Detergent (¼ oz/gallon)
- Thermal Rinse (PURW Rinse): 1 minute, 90°C
- Drying: 7 minutes, 90°C
3. Sterilization Process:
- Wrap the M6-C Surgical Instrument Tray in two layers of an FDA-cleared sterilization wrap, such as Halyard Health H600.
- Sterilize the instruments using a pre-vacuum autoclave with the following validated cycle parameters:
- Temperature: 132°C (270°F)
- Full Exposure Time: 4 minutes
- Dry Time: 60 minutes (45-minute cycle time followed by a 15-minute dwell in the sterilizer with the door opened for cooling)
Please note that these cleaning and sterilization instructions are provided as a general guide. It is essential to follow the specific instructions provided by your healthcare facility and the manufacturer's recommendations for the best results and to ensure the safety and effectiveness of the instruments.
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