Ambu Oval Plus, Instructions For Use Manual

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8.2 Cleaning procedure
The following cleaning method has been validated according to the AAMI TIR 12
standard. Ambu makes no warranties concerning other cleaning and sterilisation
methods than the validated one described here. The validated method specifies
cleaning by washing machine using detergents.
Disassemble the devices prior to placing in the washer and program the washer
for the following parameters. Place devices into washer to allow for drainage:
Phase Recirculation
time (minutes)
Water
temperature
Detergent type and
concentration (if applicable)
Pre-Wash 1 02:00 Cold tap water NA
Enzyme wash 02:00 Hot tap water Enzymatic detergent
Wash 1 02:00 60.0 °C (140 °F)
(Set point)
Enzymatic detergent
Rinse 1 0:15 Hot tap water
(60.0 °C) (140 °F)
NA
Dry the devices appropriately.
Sterilisation by gravity steam autoclave running a full cycle at 134 degrees Celsius
for 10 minutes at a standard pressure and then dry 30 minutes.
8.3 Parts that can be cleaned and sterilised
Applicable methods
X Applicable O
Not applicable
Machine Washing Disinfection & sterilisation
Autoclave 134°
Patient valve X X
Bag X X
Inlet valve X X
Extension tube X X
Silicone Facemask X X
Silicone Facemask size OA X 0
Oxygen reservoir bag X X
Oxygen reservoir tube X 0
8.4 Detergents and chemical disinfectants
Use only brands that are compatible with the resuscitator materials to avoid
reduction in the lifetime of the materials. Follow the instructions of the manufacturer
of the detergent or chemical disinfectant for dilution and exposure time.
CAUTION
Avoid using substances containing phenol to clean the product. Phenol will cause
premature wear and degradation of the materials or reduced product life span.
Promptly remove all residue of cleaning materials from the resuscitator. Residues
may cause premature wear or reduced product life span.
The following steps are generally recommended. Select proper methods for the
resuscitator parts in question according to the table above.