MEDICAL PRODUCTS

 

  STORAGE AND HANDLING

• Do not drop.
• Store in original packaging.
• Store in clean and dry conditions.
• Store on a shelf or pallet.
• If stored in a clean, dry environment, shelf life is 10+ years.

 

PREPARATION

• Product supplied as non-sterile.
• Clean before use.
• Do not use damaged product.

 

  CLEANING AND DISINFECTION

• Position products individually, avoiding contact with other items.
• Position products to allow water penetration and drainage.
• Machine clean in washer disinfectors compliant with ISO 15883.
• Use approved detergents, enzymatic or biocide cleaners, suitable for cleaning medical devices
     and surgical instruments which are compatible with polypropylene material
     (see detergent manufacturers’ guide).
• Use detergents and disinfectants with a range between 2 pH and 13 pH.
• Ultrasonic cleaning is permissible.
• Manual cleaning is permissible – separate product components and clean individually.
• Rinse with clean water.
• Dry with unwoven towels.
• Do not use abrasive materials.

 

  INSPECTION MAINTENANCE & INCIDENT REPORTING

• Visually inspect product to identify damage.
• Discard damaged product.

 

  WRAPPING

• Sterilisation wrapping sheets and pouches must be compatible with polypropylene material
     and suitable for the chosen method of sterilisation.
• Be aware that some wrapping sheets and pouches shrink during sterilisation.
• Pouches must be large enough to contain the product without stressing the seals.

 

  STERILISATION

• Moist Heat sterilisation (Steam Autoclave) at 135°C (+2°C) for a minimum of 2 minutes.
• EO Ethylene Oxide (Gas) sterilisation at maximum temperature of 65°C.
• H2O2 Hydrogen Peroxide (Plasma) sterilisation at maximum temperature of 65°C.
• Sterilisation procedures and machines to comply with the following standards AS/NZS 4187
    and amendments; ISO 17665, ISO 25424, and ISO 11135

 

  DISPOSAL

• End of life is determined by wear and tear, visual inspection, or damage to product.
• If product is contaminated treat as clinical waste and dispose of in accordance
     with clinical waste procedures.
• Product can be recycled as polypropylene, PP or the recycle number 5.WARNINGS
• Do not use abrasive powders or metal brushes as they may cause surface damage.
• For autoclaves, do not exceed 138°C.
• For washers, do not exceed 100°C.