Integra MAYFIELD A3059 Manuel D'instructions page 22

EN – ENGLISH
The MAYFIELD 2 Skull Clamp (A3059 ) has been validated for the following sterilization cycle parameters:
Cycle Conditions
Wrapped, Pre-vacuum
Wrapped, Pre-vacuum
US- Alternate Cycle
Wrapped, Pre-vacuum
UK/EU Cycle
Wrapped, Pre-vacuum
German Cycle
Wrapped, Pre-vacuum
French Cycle
Note: It is the responsibility of the end user to validate alternate sterilization methods and cycles that do
not comply with the validated sterilization methods and cycles specified within this manual.
Decontamination after Exposure to Highly Contagious Diseases (WHO):
When the MAYFIELD 2 Skull Clamp has been exposed to pathogens that resist normal disinfection
methods, the product should be handled more carefully:
Note: Do not subject the Skull Clamp to automated cleaning processes until after the decontamination procedure.
1. Remove Ratchet Extension from the Clamp Base (see Figure 5).
2. Remove and dispose of skull pins if present.
3. Remove gross debris and soil from the clamp components using soft cloth or paper towels.
Minimize formation of aerosols or droplets during the initial preparation of the product for
decontamination.
4. Remove Torque Screw from Ratchet Extension.
* Steam Sterilization is validated between 132°C - 137°C with an exposure time between 4 - 18 minutes and a dry time of 60
minutes.
Steam Sterilization Validated Cycles
Sterilization
Temperature
132°C -0/+3°C
( 270°F -0/+5°F )
US cycle
132°C -0/+3°C
( 270°F -0/+5°F )
134°C -0/+3°C
( 274°F -0/+5°F )
134°C -0/+3°C
( 274°F -0/+5°F )
134°C -0/+3°C
( 274°F -0/+5°F )
• Wear appropriate personal protective equipment (eye/face protection, gloves)
• Keep soiled areas of the device moist. Do not apply gluteraldehyde, alcohol or formalin to
the device until the decontamination process is complete.
• Visually confirm there are no skull pins in the Rocker Arm or Torque Screw sockets.
Exposure Time
(minutes)
3
4
3
5*
18*
Table 7 Validated Cycles
22
Dry Time
(minutes)
30
60
30
60
60