Huntleigh dopplex Intraoperative Probe Mode D'emploi page 4

RECOMMENDED CLEANING AND STERILISATION
NON STERILE - PRE-CLEAN AND STERILISE BEFORE USE
Only use 1 sterilisation method
Limitations on
If probe is damaged Do Not re-use.
reprocessing
Do Not exceed the number of uses.
On completion remove a cut-out from the tracking label.
Pre-clean the IOP8 prior to sterilisation by any of the following techniques
Automatic A typical operating cycle is:-
Washer
Disinfector
Ultrasonic bath
Follow manufacturers instructions
Manual cleaning
Only undertake when other mechanical methods are unavailable.
/ washing
Take necessary precautions when manual cleaning / washing.
Use hand hot water with detergent (pH 5 - 5.5). Use bottlebrush if necessary.
Always use established temperatures, pressures and holding periods
On completion remove a cut-out from the tracking label.
Vacuum Autoclaving - 1
Vacuum Autoclaving - 2
ETO
Steris System 1
Visually inspect for damage.
Inspection
Packaging
Pack each probe individually. Use suitable container for sterilisation technique.
Storage No particular requirements
After use
Containment and transportation
Preparation for cleaning
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.
WARNINGS
6 Autoclave Cycles
30 ETO Cycles
30 Steris System 1 Cycles
Pre-cleaning instructions
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)
Sterilisation
Temperature (min/max)
134 / 137°C
121 / 123°C
55°C
51 / 56°C
Instructions - after use
Remove gross debris, place in an enzyme solution or tap water.
Reprocess as soon as possible
IOP8 has no removable parts.
Pressure (min/max)
2.0 / 2.2 bar
1.1 / 1.2 bar
Atmospheric-non-
pressure
4
Do not exceed 137°C
Holding Period (min/max)
3.0 / 3.5 minutes
15.0 minutes
6 hours cycle duration
25 / 30 min cycle