Sterilisation: Rubber Dam Clamps

This information is based on our present knowledge. However, this shall not constitute a guarantee for any specific product features and shall not establish a legally valid contractual relationship.

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.

It is recommended that clamps be used for a maximum of 12 months. Following these guidelines during procedures may assist in minimising clamp failure due to cracking:

a. Clamps should be thoroughly rinsed after detergent cleaning.
b. Sodium hypochlorite solution containing no surfactants should be used.
c. Clamps should not be moved whilst exposed to sodium hypochlorite.
d. Clamps should be rinsed with water once treatment with sodium hypochlorite is complete.
e. Clamps should be rinsed before removal and thoroughly afterwards.
f. Exposure times should be kept to a minimum.

1. WARNINGS: Clamps are not sterile upon receipt and must be sterilised before use in accordance with the following instructions. Clamps 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 clamps should be handled with gloves and eye protection should be used.

2. Limitations on Reprocessing: Repeated processing has minimal effect on these clamps. End of life is normally determined by wear and damage due to use. See Inspection.

Instructions

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

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

5. Preparation for Cleaning: No specific requirements.

6. Automatic Cleaning: Equipment: Use only validated washing machines (HTM 2030: UK only) and validated cleaning agents suitable for both clamps 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: Discard damaged/worn clamps.

8. Inspection and Function Testing: Visually inspect to ensure all contamination has been removed. Check for distortion, damage and wear. Discard damaged, worn or corroded clamps.

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 clamps. Autoclaves drawing only a post-sterilisation vacuum for drying purposes are not suitable for processing wrapped clamps. Clamps may be loaded into dedicated clamp trays or general-purpose sterilisation trays.

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 clamps 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.

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.