Huntleigh dopplex IOP8, Instructions For Use Manual, Page: 4 / 76

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RECOMMENDED CLEANING AND STERILISATION
NON STERILE - PRE-CLEAN AND STERILISE BEFORE USE
WARNINGS
Limitations on
reprocessing
Only use 1 sterilisation method
If probe is damaged Do Not re-use.
Do Not exceed the number of uses. Do not exceed 137°C
6 Autoclave Cycles
30 ETO Cycles
30 Steris System 1 Cycles
On completion remove a cut-out from the tracking label.
Pre-cleaning instructions
Pre-clean the IOP8 prior to sterilisation by any of the following techniques
Automatic
Washer
Disinfector
A typical operating cycle is:-
Wash at ~ 65°C with detergent (pH 5-13.2)
Rinse at ~60°C - rinse aid (pH 2.0±0.5) may be added
Disinfection cycle - 93°C (max) held for 1 min. or 71°C (min) held for 3 mins.
Heat assisted drying cycle - 82°C (max)
Ultrasonic bath Follow manufacturers instructions
Manual cleaning
/ washing
Only undertake when other mechanical methods are unavailable.
Take necessary precautions when manual cleaning / washing.
Use hand hot water with detergent (pH 5 - 5.5). Use bottlebrush if necessary
Sterilisation
Always use established temperatures, pressures and holding periods
On completion remove a cut-out from the tracking label.
Temperature (min/max) Pressure (min/max) Holding Period (min/max)
Vacuum Autoclaving - 1 134 / 137º C 2.0 / 2.2 bar 3.0 / 3.5 minutes
Vacuum Autoclaving - 2 121 / 123º C 1.1 / 1.2 bar 15.0 minutes
ETO 55º C
Atmospheric-non
pressure
6 hours cycle duration
Steris System 1 51 / 56º C - 25 / 30 min cycle
Inspection Visually inspect for damage.
Packaging
Pack each probe individually. Use suitable container for sterilisation
technique
Storage No particular requirements
Instructions - after use
After use Remove gross debris, place in an enzyme solution or tap water.
Containment and transportation Reprocess as soon as possible
Preparation for cleaning IOP8 has no removable parts
The instructions provided above have been validated as being CAPABLE of preparing a device for
re-use. It remains the responsibility of the reprocessor to ensure that the reprocessing as actually
performed using equipment, materials and personnel in the reprocessing facility achieve the desired
result. This normally requires validation and routine monitoring of the process. Likewise any deviation
by the reprocessor from the instructions provided should be properly evaluated for effectiveness and
potential adverse consequences.