NSK Varios 370 - Sterilization Procedures; Autoclave Procedure and Conditions

8
CAUTION
•
Control Unit Holder is not necessary when rubber pads are applied.
Steam Sterilization Cycle
Type Gravity Displacement Pre-vacuum
Minimum Temperature
121˚C 132˚C 135˚C 135˚C
Full Cycle Time 20 minutes 15 minutes 10 minutes 10 minutes
Minimum Dry Time 10 minutes 10 minutes 10 minutes 15 minutes
NOTE
• NSK recommends sterilization according to ANSI/AAMI ST79 and EN 13060 (class B).
• Follow the manufacturer's instructions for use that came with your sterilizer.
• For more information about sterilization standards, refer the medical device regulations
specific to your location.
Fig. 6
Rubber
Pad
3-6 Rubber Pad
To prevent the control unit from slipping apply
rubber pads.
1
)
Clean bottom of the Control Unit.
2
)
Fit the Rubber Pad appropriate place as shown
on the Fig. 6.
4. Sterilization before first time use
NSK Varios components are not sold sterile and should be sterilized prior to first time you use.
Autoclave sterilization is recommended.
Please note the following when sterilize components.
Follow your local directives, standards, and guidelines.
Sterilize components in a U.S. FDA-cleared sterilization pouch, complaint to ISO 11607-1.
Ensure that you only remove dry sterile goods from the sterilizer.
Store sterile goods dust-free and dry.
Autoclave Procedure
1) Pick a tip up from the tip case. Take handpiece out of the packing bag before sterilization.
2) Insert sterilizable components into a U.S. FDA-cleared sterilization pouch, complaint to ISO 11607-1. Seal the pouch.
3) Autoclave conditions are below:
< When sterilizing a Tip>
Steam Sterilization Cycle
Type Gravity Displacement Pre-Vacuum (Dynamic Air Removal)
Minimum Temperature
132°C 135°C 132°C 134°C* 135°C
Full Cycle Time 15 minutes 10 minutes 4 minutes 3 minutes 3 minutes
Minimum Drying Time 15 minutes 30 minutes 20 minutes 30 minutes 16 minutes
* Not for use in the U.S.
<When sterilizing components except for a Tip>