acumed Polarus Instrucciones De Uso página 49

EN Instructions for use
PRE-STERILIZATION INSPECTION
• Visually inspect all devices under normal lighting to ensure that cleaning was effective. Pay close
attention to all challenging areas.
- Re-process an instrument that is not clean.
- Replace an instrument that cannot be cleaned.
• Inspect the implants and instruments for surface damage, such as nicks, scratches, and cracks. Replace
any device that is affected.
• Assess the instruments for proper use. Operate all parts and connecting mechanisms. Give careful
attention to drivers, drill bits and reamers, and instruments used for cutting or implant insertion.
Critically assess them for wear, sharpness, straightness, and corrosion. Replace any instrument that
does not perform as intended.
• Inspect all cutting edges under magnification.
- Replace an instrument if a cutting edge is dull, chipped, cracked, rolled, or otherwise deformed.
- Running a cotton cloth over the edge may help detect chipping and cracking.
• Verify the legibility of all markings and reference scales. Replace any device that is unreadable.
• Repair, replace, and/or repeat the cleaning of instruments as needed to ensure proper operation before
proceeding with sterilization.
• Lubrication ("instrument milk") may increase the useful life of surgical instruments. Do not use silicone-
based lubricants, oil, or grease, as these will interfere with steam sterilization. Only use a water-based
lubricant intended for use on surgical instruments and with steam sterilization. Use the lubricant as
directed by the manufacturer. Use critical water if dilution is required.
• Fully replenish the system trays and caddies.
STERILIZATION
• Perform sterilization using a dynamic-air-removal (prevacuum) autoclave.
- Gravity displacement sterilization is not recommended.
- Immediate use (flash) sterilization is not recommended.
• Ensure the sterilizer's maximum load limit is not exceeded when sterilizing multiple sets or devices.
• Do not stack containers as this might prevent the penetration of steam and inhibit drying.
• Refer to the sterilizer manufacturer's instructions and ensure proper installation, calibration, use, and
ongoing maintenance.
• The sterilized items should be allowed to cool to room temperature before handling. This allows for
safe handling and preventing condensation.
• Follow current industry best practice guidelines such as ANSI/AAMI ST79:2017*.
* Association for the Advancement of Medical Instrumentation (AAMI). Comprehensive guide to steam
sterilization and sterility assurance in health care facilities. AAMI ST79:2017. Arlington, VA.
• The following table shows the minimum parameters validated* to achieve a required Sterility Assurance
Level (SAL) of 10 for the system.
-6
Important:
- Sterilization parameters are only valid for devices that have been cleaned per these instructions
and are thoroughly dry.
- Sterilization parameters are only valid when the devices are properly housed in the Acumed
storage case part numbers identified in the table.
English (non-U.S.) – EN / PAGE 49