Sterilisation: Hand Instruments

These instructions have been validated by the manufacturer as being capable of preparing a device for re-use. It remains the responsibility of the reprocessor to ensure that the reprocessing has actually achieved the desired result. This normally requires validation and routine monitoring of the process. Any deviation by the reprocessor from these instructions should be properly evaluated for effectiveness and potential adverse effects.

Sterilisation instructions can be downloaded as PDF files. To view PDF files you will need Acrobat Reader software installed on your computer. Acrobat Reader is a registered trademark of Adobe Systems Incorporated in the United States and/or other countries.

1. WARNINGS: Instruments are not sterile upon receipt and must be sterilised before use in accordance with the following instructions. Instruments can be damaged by alkaline and acidic detergents. Always use a pH neutral detergent or solution. Do not exceed 140°C. Remove all packaging prior to cleaning and sterilisation. Contaminated instruments should be handled with gloves and eye protection should be used.

2. Limitations on Reprocessing: Repeated processing has minimal effect on these instruments. End of life is normally determined by wear and damage due to use. See Inspection. Do not place Ceramicolor instruments in direct contact with steel instruments or metal baskets as this may damage the glaze leaving a grey marking on the handle. Never clean colour-etched probes or black composite instruments in ultrasonic baths. Do not subject Flexichange instruments to dry heat sterilisation.

Instructions

3. Point of Use: Remove all excess soil with a disposable cloth paper wipe.

4. Containment and Transportation: Protect delicate or fine instruments from damage. Instruments should be reprocessed as soon as is reasonably practical following use. Instruments left standing wet may stain or corrode.

5. Preparation for Cleaning: No specific requirements. Disassembly not required.

6. Automatic Cleaning: Use only validated washing machines (HTM 2030: UK only) and validated cleaning agents suitable for both instruments and washing machine. Follow instructions issued by both the equipment and cleaning agent manufacturers. When unloading, inspect for complete removal of visible soil. If necessary, repeat cycle, or use manual cleaning before repeating cycle.

7. Maintenance: Apply a small quantity of surgical grade lubrication oil to forceps hinges prior to sterilisation.

8. Inspection and Function Testing: Visually inspect to ensure all contamination has been removed. Check for distortion, damage and wear. Cutting edges should be free of defects. Discard damaged, worn or corroded instruments. Ensure that detachable tips are secure.

9. Drying: Dry using paper towelling or dry heat not exceeding 140°C.

10. Packaging for Sterilisation: The UK Dept. of Health recommends that validated, pre-vacuum autoclaves are used for sterilising wrapped instruments. Autoclaves drawing only a post-sterilisation vacuum for drying purposes are not suitable for processing wrapped instruments. Instruments may be loaded into dedicated instrument trays or general- purpose sterilisation trays. Ensure that cutting edges are protected.

11. Sterilisation: Use only validated vacuum autoclaves (Refer to HTM2010: UK only). Do not exceed 140°C.

* Minimum holding time when nominal operating temperature and pressure have been reached.

12. Storage: Avoid contamination.

13. Additional Information: When sterilising multiple instruments in one autoclave cycle, ensure that the manufacturers stated maximum load is not exceeded. Validated ultrasonic baths may be used with validated cleaning agents. Follow instructions for use issued by both the equipment and cleaning agent manufacturers.

14. Manufacturer Contact: See brochure for telephone and address of local representative or telephone DENTSPLY Ash Instruments. Tel: +44 (0)1932 853422.