Integra MAYFIELD 2 Manual De Instrucciones página 18

Decontamination:
When the MAYFIELD 2 Skull Clamp has been exposed to pathogens that resist normal disinfection
methods, the product should be handled more carefully:
• 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.
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).
• Visually confirm there are no skull pins in the Rocker Arm or Torque Screw sockets.
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.
5. Place parts in a shallow pan and add enough chlorine solution 2 to cover the device completely.
• Allow to soak for 60 minutes.
6. Remove the device from the bleach solution and rinse components completely with water.
• The Skull Clamp may then be autoclaved at 134 degrees C for 18 minutes to one hour.
• The Skull Clamp has been verified through testing to withstand this process up to 15 times
without loss of performance.
NOTE: Integra makes no claims that the following protocol is effective in neutralizing any specific
pathogens.
World Health Organization (WHO) Protocol for Decontamination of highly infectious diseases 3 :
"Immerse [instrument] in sodium hypochlorite for 1 hour; remove and rinse with water, then transfer to
open pan and heat in a gravity displacement autoclave at (121° C) or porous load (134°C) for 1 hour."
2. Recommended concentration is 20,000 ppm available chlorine. See Bleach Dilution section.
3. WHO/CDS/CSR/APH/2000.3, "WHO Infection Control Guidelines for Transmissible Spongiform
Encephalopathies", (Switzerland, March 1999) pp 29
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