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5. Preparation for use
5.1. Cleaning and sterilization
Cleaning and sterilization as described below must be carried out before initial use and before
each subsequent use as the Ambu® Aura40 is delivered non-sterile.
The Ambu® Aura40 can be used a maximum of 40 times provided the recommended cleaning,
sterilization and handling procedures are followed. Proper cleaning and sterilization of the device
is essential to ensure continued safe usage up to 40 times.
A record card for sterilization of the Ambu® Aura40 accompanies every device from delivery.
To ensure a proper documentation of the sterilization cycles, the record card should be completed
each time the Ambu® Aura40 is sterilized.
Ambu A/S has validated the instructions provided in 5.1.1. and 5.1.2. as being capable of preparing
an Ambu® Aura40 for re-use. Any deviation from the instruction provided should be properly
evaluated for effectiveness and potential adverse consequences.
5.1.1. Cleaning instruction
It is recommended to follow the described validated manual or automated cleaning procedure to
ensure proper cleaning.
It is important to keep the manual vent closed during cleaning to prevent exposure of the inflation
valve to any liquid.
See figure
A. Closed manual vent.
The Ambu® Aura40 should be kept moist between the time of use and subsequent cleaning.
Remove excess soil with disposable cloth/paper wipe. Thoroughly rinse the Ambu® Aura40 in cold
running tap water to avoid protein coagulation.
It is recommended to use one of the two following cleaning methods:
To ensure proper cleaning of the airway tube a soft bristle brush is recommended. Brushes should
fit tightly, but be able to move back and forth in the area being cleaned. Never use hard brushes or
other materials that might damage the silicone cuff or surface.
Remove all cleaning residues by thoroughly rinsing the cuff and the airway tube in running warm
tap water for 1 minute. Make sure that the water passes through the tube. Closely examine the
Ambu® Aura40 to ensure that all visible foreign matter has been removed. Repeat the above
procedure if necessary. If liquid is noticed in the inflation valve, shake the pilot balloon and tap
the inflation valve and manual vent against a towel to remove excess liquid. Dry the device using
a soft clean cloth.
Manual Cleaning Procedure
1. Rinse device under running cold utility (tap) water for a minimum of one minute to remove
visible soil.
1.1. While rinsing, flush the inside of the airway tube with 20 ml of utility (tap) water.
1.2. Use a soft bristle lumen brush to brush the airway tube for a minimum of 15 seconds.
2. Prepare a detergent bath using Neodisher Mediclean Forte or an equivalent detergent solution
at the detergent manufacturer’s recommendation.
