12
Product testing has shown that the Ambu Oval Plus Silicone Resuscitator is fully functional
after 30 full reprocessing cycles, as listed in Table 1, with the exception of the oxygen
reservoir bag, which can be sterilized a maximum 15 times or chemically disinfected a
maximum 30 times�
It is the user’s responsibility to qualify any deviations from the recommended cycles and
methods of processing, and to monitor that the recommended number of reprocessing
cycles is not exceeded�
Always perform a test of functionality prior to each use (see section 4�2�2�)
Procedures for reprocessing
MANUAL CLEANING
1� Rinse the components under running cold utility (tap) water to remove gross soil�
2� Prepare a detergent bath using a cleaning detergent solution, e�g� Neodisher®
MediClean Forte or equivalent, for the removal of residues of dried and denatured
blood and proteins, using the detergent manufacturer’s recommended concentration�
3� Fully immerse the components to keep them submerged in the solution according to
the detergent instruction label� During the soak time thoroughly clean the components
with a soft brush and flush the bags and lumens until all visible soil is removed�
4� Thoroughly rinse the articles by fully immersing them in tap water, agitating and
allowing them to set for a minimum of 3 minutes�
5� Repeat the previous step two more times for a total of three rinses using a fresh batch
of tap water each time�
6� Dry the components with a clean lint-free cloth and compressed air�
AUTOMATED CLEANING AND THERMAL DISINFECTION (NOT APPLICABLE FOR
OXYGEN RESERVOIR TUBE)
1� Rinse the components under running cold utility (tap) water to remove gross soil�
2� Place the components onto a manifold rack or in a wire basket contained inside
the washer�
3� Select the cycle as listed in table 2:
Stage
Recirculation
time (minutes)
Temperature
Detergent type
and concentration
Pre-wash
02:00
Cold tap water
N/A
Wash
01:00
43 °C (110 °F)
tap water
Neodisher® MediClean Forte
or an equivalent detergent
using manufacturer’s
recommended concentration
Rinse
05:00
43 °C (110 °F)
tap water
N/A
Thermal
disinfection
05:00
91 °C (196 °F)
N/A
Dry Time
07:00
90 °C (192 °F)
N/A
Table 2: Automated cleaning procedure for Oval Plus Silicone Resuscitator
(not applicable for oxygen reservoir tube).
CHEMICAL DISINFECTION
1� Equilibrate the bath of Cidex OPA, or an equivalent OPA (ortho-phthalaldehyde),
disinfectant at the temperature specified in the OPA disinfectant manufacturer’s
instructions�
2� Ensure the minimum effective concentration (MEC) of the OPA disinfectant using the
OPA test strips specified in the OPA disinfectant manufacturer’s instructions�
3� Fully immerse the device in the OPA and ensure that all air bubbles are removed from
the device surface by agitating the device�
4� Allow the device to soak for the time specified by the OPA disinfectant manufacturer’s
instructions�
5� Thoroughly rinse the device by fully immersing it in purified water, agitating and
allowing it to set for a minimum of 1 minute� During the rinse, flush the bag with the
purified water�
6� Repeat step 5 two more times for a total of 3 rinses using a fresh batch of purified
water each time�
7� Dry the device using a sterile lint-free cloth�
