How to sanitize the ORTHOFIX Lonestar Cervical Stand Alone System implants and instruments? (ORTHOFIX Lonestar Cervical Stand Alone System Instructions Manual)

Answer

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Mar 06, 2025 - 01:00 AM

The ORTHOFIX Lonestar Cervical Stand Alone System implants and instruments are provided non-sterile and will require thorough cleaning and sterilization prior to each use. Here is the recommended cleaning and sterilization process:

1. Cleaning:
- Remove excess body fluids and tissue from instruments with a disposable, non-shedding wipe.
- Soak the instruments for a minimum of 10 minutes in purified water prior to the manual or automated cleaning process.
- Use a soft cloth or a soft plastic bristle brush to remove any visible soil from the instruments.
- Lumens should be cleaned with a long, narrow, soft-bristled brush.
- Enzymatic detergent should be used for manual and automated cleaning.
- Rinse the instruments in tap water for a minimum of 3 minutes, thoroughly flushing lumens and hard-to-reach areas.
- Place the instruments in a sonication unit with prepared cleaning solution and sonicate for 10 minutes.
- Rinse the instruments in purified water for at least 3 minutes, thoroughly flushing lumens and hard-to-reach areas.
- Repeat the sonication and rinse steps.
- Remove excess moisture from the instruments with a clean, absorbent, and non-shedding wipe.
- Inspect the instruments for visible soil, repeating the cleaning steps if necessary.

2. Sterilization:
- The implants and instruments can be sterilized using either steam sterilization or rigid sterilization containers.
- For steam sterilization, use a gravity or prevac cycle at a temperature of 270°F (132°C) for 15 minutes exposure time, followed by drying for 30 minutes.
- For rigid sterilization containers, follow the manufacturer's instructions and use a prevac cycle at a temperature of 270°F (132°C) for 4 minutes exposure time, followed by drying for 30 minutes.

Note: Do not re-sterilize single-use implants that come in contact with body fluids. Non-sterile implants and instruments must be thoroughly cleaned and sterilized before each use.

Please refer to the ORTHOFIX Lonestar Cervical Stand Alone System Instructions for Use for more detailed instructions and any specific recommendations.