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21
9. Cleaning and sterilization
Instructions continued
Drying
Hot Air Dry
Maintenance
Check for obvious signs of damage – return to manufacturer if any damage is noted.
Inspection &
Function Testing
Visually inspect for damage and wear. Check probe tips for signs of bending, distortion or other damage. Connect Cryo Probe to
‘Cryomatic MKII’ console to check correct and smooth function of probe quick release coupling.
Packaging
Paper autoclave bag meeting ISO 11607 requirements with chemical indicators meeting ISO 11140-1, or follow guidance
provided in ANSI/AAMI ST79 - Refer to the product-specific instruction manual for compatibility with steam sterilisation.
Sterilisation
Cryo Probe must be cleaned prior to sterilisation. Thorough cleaning removes both micro-organisms and organic material.
Failure to remove organic material decreases effectiveness of the sterilisation procedure. After cleaning, make sure that the
instrument is carefully dried.
Place the instruments in appropriate instrument trays or pouches. Wrap or seal them adequately. Do not seal the instruments in
close contact with each other as this might impair the sterilisation effect.
Never rinse the instruments with cold water for cooling. Be careful when unloading the autoclave, the contents may be hot.
Make sure that the sterile package of the instruments is not damaged. If the package has been perforated, if the sealing has
been opened, if the packaging is wet or if the packaging is damaged in any other way, repackage and then re-sterilise the
instruments.
Disinfection is only acceptable as a precursor to full sterilisation for reusable surgical instruments. See Table 1 for recommended
sterilisation parameters using equipment meeting relevant standards. These parameters have been validated by the manufacturer as
providing effective sterilization, and are in accordance with the typical cycle parameters in ANSI/AAMI ST79 Table 5.
Steriliser manufacturer recommendations should always be followed. When sterilising multiple probes in one sterilisation cycle,
ensure that the manufacturer's maximum load is not exceeded.
It is the responsibility of the user to validate any sterilisation process that deviates from these recommendations.
Table 1
Sterilizer type
Temperature
Pressure
Exposure time
Drying time
Pre-vacuum (porous load)
134 – 137 °C (273 – 279 °F) -
3 minutes
20 minutes
NB: For users concerned with reducing the infectivity of prions, a pre-vacuum cycle of 134 – 137 °C (273 – 279 °F)
for 18 minutes with the same drying time as above has also been validated by the manufacturer