Cortex CryoPro Gebrauchsanweisung Seite 49

INSTRUCTIONS
Cleaning: Manual
Disinfection
Drying
Maintenance, inspection, and testing
Packaging
Sterilization
Storage
Additional information
Manufacturer contact
The instructions provided above have been validated by the manufacturer of the medical device as being capable of preparing the contact probes for
reuse. It remains the responsibility of the processor to ensure that the processing, as actually performed using equipment, materials, and personnel in
the processing facility, achieves the desired result. This requires verification and/or validation and routine monitoring of the process.
Date issued: 2025-01-31
Cleaning agent: Prolystica 2X Concentrate Neutral Detergent from the manufacturer Steris. Composition
of the detergent is shown below:
Name
Ethoxylated Alcohol Surfactant
Poly(oxy-1, 2-ethaediyl), .alpha.-phenyl-.omega.-hydrixy-
1-Octanamine, N, N-dimethyl-, N-oxide
Methyl-oxirane polymer with oxirane
Cleaning instructions:
1. Dilute the detergent in tap water (1 ml detergent per 1 liter of water, as worst-case dosage).
2. Once the protective silicone caps are mounted, immerse the entire contact probe in the solution and
leave for 5 minutes.
3. Carefully remove the contact probe from the solution and brush the contact probe for minimum 1
minute to remove visible debris. Use a soft nylon brush that does not scratch the surface.
4. Rinse the contact probe under running water and brush until visibly clean for at least 1 minute. Tap water
can be used.
The cleaning procedure must be performed prior to sterilization.
The CryoPro contact probes are not intended to be disinfected. A sterilization instruction is provided
below.
Dry the contact probe with a clean lint-free wipe and prepare for sterilization.
1. Inspect the contact probe for any visible debris.
2. Inspect the contact probe for any signs of a compromised surface. The contact probe must be
discarded in such case, as scratches or loosening of the surface coating may bring the patient into
contact with underlaying materials or debris that are not biocompatible.
Place the cleaned contact probe in a single pouch suitable for steam sterilization (sterilization test
validated with WIPAK STERIKING® See-through Heat-sealable Pouches).
Make sure that the silicone vent tube is not attached, and that the protective silicone cap and stud are in
place during the sterilization process to prevent steam/water from entering the lumen inside the device.
In case water is trapped inside the probe it will freeze during use and block the nitrogen flow.
Processing parameters that have been validated to effectively reach a sterility as-surance level (SAL) of
1x10-6 are summarized below:
Autoclave cycle type
Gravity displacement
(Type N autoclave)
Allow the sterilized devices to properly cool to room temperature in a dedicated area with minimum traffic
and air flow for minimum 30 minutes.
Do not open the sterilization pouch until the device has been transported to the point of use. The silicone
vent tube should not be attached until the device has been transported to the point of use.
CryoPro contact probes must be stored at regular room temperature and humidity. Apart from that, there
are no special storage requirements and no restrictions on shelf-life.
The contact probes are intended to be sterilized before use and can be stored according to the
specifications of the sterilization pouch manufacturer.
Cortex Technology, Niels Jernes Vej 6B, 9220 Aalborg, Denmark
Phone: +45 98574100, Email: cortex@cortex.dk
Temperature Exposure time (Min.)
121 °C (250 °F) 15 minutes
Product identifier
(CAS No) 68439-46-3
(CAS No) 9004-78-8
(CAS No) 2605-78-9
(REACH No) 01-2119409076-45-0002
(CAS No) 9003-11-6
Drying time (Min.)
20 minutes
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