English
• In US double wrap basket or instruments with an FDA cleared
sterilization wrap using appropriate wrapping techniques described
in ANSI/AAMI ST79 (For example: Simultaneous double wrapping or
sequential wrapping).
• Outside US double wrap basket or instruments in accordance with
local procedures, using standard wrap and wrapping techniques
such as those describe in ANSI/AAMI ST79.
Warning: When using a sterilization wrap the basket lid must be used.
Must follow manufacturer's instructions for any wraps used. Do not use
individual sterilization pouches. Only use indicated basket for equipment.
3. Sterilization
• Sterilize in accordance with the following guidelines.
Warning: Do not use any other sterilization method or cycle other than those
listed below which have been validated in accordance with ISO 17665.
US Steam Autoclave Instructions
Option
1. Pre-Vacuum*
2. Gravity Air
Displacement*
* Wrapped or unwrapped
Outside US Steam Autoclave Instructions
Option
1. Pre-Vacuum*
2. Pre-Vacuum*
3. Gravity Air
Displacement*
* Wrapped or unwrapped.
Caution: A drying cycle is required to avoid possible adverse effects
caused by exposure to condensation.
Notes:
• Metal devices, tools and equipment are constructed of materials
unaffected by normal environmental conditions of current standard
sterilization means, when proper operational techniques are
employed.
14
Exposure
Temperature
132°C
132°C
Exposure
Temperature
132°C
134 - 138°C
132-138°C
Exposure
Time
4 minutes
15 minutes
Exposure Time
4 minutes
3-18 minutes
15-18 minutes
Minimum Dry
Time
40 minutes
40 minutes
Minimum
Dry Time
40 minutes
40 minutes
40 minutes