Integra MAYFIELD 2 A3100 Mode D'emploi page 17

Step 1: Decontamination after Exposure to highly infectious diseases*
When the MAYFIELD 2 System has been exposed to pathogens that resist normal disinfection methods, the product should
be handled more carefully. The following steps are recommended in accordance with the World Health Organization (WHO)
Protocol for decontamination of highly infectious diseases**:
• 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 base unit & skull clamp to automated cleaning processes until after the decontamination
procedure.
1. Remove gross debris and soil from the device components using soft cloth or paper towels. Minimize formation of
aerosols or droplets during the initial preparation of the product for decontamination.
2. Place parts in a shallow pan and add enough chlorine solution to cover the device completely. Note: Recommended
concentration is 20,000 ppm available chlorine. See Bleach Dilution section-Appendix A.
• Allow to soak for 60 minutes.
3. Remove the devices from the bleach solution and rinse components completely with water.
• The devices may then be autoclaved at 134°C for 18 minutes to one hour.
• The devices have been verified through testing to withstand this process up to 15 times without loss of
performance.
*Highly infectious diseases including but not limited to transmissible spongiform encephalopathies (TSEs) and Creutzfeldt-Jakob disease (CJD), also known as prion diseases (reference WHO/CDS/CSR/APH/2000.3,
"WHO Infection Control Guidelines for Transmissible Spongiform Encephalopathies", (Switzerland, March 1999) Section 1). ** Integra makes no claims that the following protocol is effective in neutralizing any specific
pathogens. The protocol is a recommendation from the World Health Organization (WHO) based on the best available evidence at the time of publication. As stated in the World Health Organization (WHO) Protocol
for Decontamination of highly infectious diseases. "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."(Reference WHO/CDS/CSR/APH/2000.3, "WHO Infection Control Guidelines for Transmissible Spongiform Encephalopathies", (Switzerland, March 1999) pp 29).
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