3. Automated Cleaning Cycle Parameters
■ Note:
Automated washing shall be conducted in a validated washer-disinfector in compliance to ISO 15883-1 and -2, or to an
equivalent standard. Load the device components in the washer-disinfector in accordance with manufacturer’s instruc-
tions, ensuring that the devices and lumens can drain freely. Automated washing can be included as part of a validated
washing, disinfection, and/or drying cycle in accordance to manufacturer’s instructions.
Cycle
Minimum Time
(minutes)
Water Type &
Minimum Temperature
Type of Detergent
Pre-wash
2
Cold tap water
N/A
Wash I
2
Cold tap water (< 40 °C/104 °F)
Cleaning agent
Wash II
5
Warm tap water (> 40 °C/104 °F)
Cleaning agent
Rinse
2
Warm deionized water or
purified water (> 40 °C/104 °F)
N/A
Thermal disinfection
5
≥ 93 °C/199 °F)
N/A
Dry
40
≥ 90 °C/194 °F
N/A
4. Inspect Device
Remove all devices from the washing basket.
Inspect the cannulations, sliding sleeves, etc. for visible soil. If necessary, repeat the manual pre-cleaning/automated
cleaning cycle. Confirm that all parts are free of moisture both inside and outside. A reduction of the dry time may lead
to damage to the device due to the presence of moisture. Such damage will not be covered by warranty.
▲ Precaution:
•
Automated cleaning is an additional stress for devices, especially for seals and bearings. Therefore, devices must be
properly lubricated after automated cleaning as indicated on page 37.
Care and Maintenance
Cleaning and Disinfection
Automated Cleaning Instructions with Manual Pre-Cleaning
36
Instruction for Use • UNIUM
™
