Cleaning And Sterilization Of Cryopro® Contact Probes - Cortex Cryopro Gebrauchsanweisung

CLEANING AND STERILIZATION OF CRYOPRO® CONTACT PROBES
According to ISO 17664-1:2021 Table B.1 – Processing instructions (reusable medical devices).
Manufacturer: Cortex Technology Aps
Device(s): CryoPro® contact probes (REF CP SP, CP 1mm-30mm)
WARNINGS
Limitations on processing:
INSTRUCTIONS
Initial treatment at the point of use
Preparation before cleaning
Cleaning: Automated
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Method: Symbol:
The devices are delivered in a non-sterile state and must be cleaned and sterilized before use.
Gloves, goggles, and suitable protective clothing should be worn during the cleaning process.
Failure to remove contaminants from the surface of the contact probe could com-promise the correct
functioning, its safe use, and the subsequent sterilization process.
Only sterilization using hot steam is recommended. Other sterilization methods based on e.g. EtO gas,
liquid chemicals, dry heat, VHP, or ionizing radiation have not been validated to be effective and may
cause physical harm to the product.
To avoid burns, allow the devices too cool after sterilization (minimum 30 minutes).
Re-processing has minimal effect on the contact probes. The end of life is determined by physical
wear and tear. Do not use the contact probes if the gold coated applied part is discolored or has signs
of physical damage (e.g., scratches). The threaded brass part of the probe will turn brown/black as it
tarnishes. This is a normal process that does not affect the functionality of the product and is of purely
cosmetic concern.
The contact probes have successfully been validated to withstand up to 100 cleaning and sterilization
cycles. Replace the probe after 100 reprocessing cycles or in case of discoloration or physical damage
to the gold coating on the part that may get in contact with the patient.
To avoid contamination, the contact probe should be kept in the sterilization pouch during transport from
the autoclave to the point of use. When opening the sterilization pouch, be careful not to contaminate the
probe before use. The protective silicone cap must be replaced by the silicone vent tube and the silicone
stud must be removed before use.
At the point of use it must be inspected if the contact probe surface is intact. The contact probe must
be discarded in case of discoloration or surface defects in the gold coating.
After use, detach the contact probe from the CryoPro®. Remove any gross soiling using a clean lint-free
wipe.
Before re-use, the contact probe must be cleaned and sterilized according to the validated procedure
described below.
Replace the silicone vent tube on the contact probe with the protective silicone cap (see image below).
Also, attach the silicone stud in the brass thread, as any liquid ingress may block the nitrogen flow during
use when it freezes.
The contact probes are not suitable for ultrasonic or automated cleaning processes due to the risk of
liquid ingress that may block the nitrogen flow. Therefore, only a manual cleaning method is provided.
Silicone stud
Protective