Dentatus Profin PDX Manual De Instrucciones página 11

Inspection and Testing Inspection
Visually inspect for damage and wear.
- No scratches.
- Check that there is no gap between head and body.
- Check that screws are even with surface.
Testing
Check the chuck by inserting a tip. You should not be able to easily pull out the tip with your finger.
If any of the above appears, do not use the handpiece and contact the manufacturer
Packaging for Equipment
sterilization Sterile goods packing.
1. Pack individually.
2. Check that the bag is not stretched.
3. Check correct sealing.
Caution: The handpiece must be cleaned and disinfected before sterilization.
Sterilization
Equipment
Saturated steam sterilizer including fractionated pre-vacuum before sterilization phase and final post-vacuum drying (B-process).
Temperature
134°C (273°F)
Time
Minimum of 3 minutes.
Pressure
3.06 bar (27 psi).
Vacuum drying
Minimum 3 minutes.
Storage Protect from dust, dirt and humidity, UV-light (sunlight) and extreme temperature (above room temperature).
Before use ensure the sterile bag is dry, whole and clean
Additional information If delayed cleaning, corrosion may affect the surface.
1)
Automated machine for both internal and external cleaning.
2)
Sterile goods packing according to EN 868-5.
3)
Steam sterilizer shall be in accordance with standards EN 13060, EN 285 and EN ISO 17665-1.
4)
All equipment, detergents, spray, lubricants and disinfections solutions shall be CE-marked as per directive 93/42/EEC.
The instructions provided have been validated by the manufacturer of the medical device as being capable of preparing a medical device for reuse. It remains the
responsibility of the processor to ensure that the processing, as actually performed using equipment and materials in the processing facility, achieves the desired result.
This requires verification and/or validation and routine monitoring of the process.
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