Cleaning Instruction; Sterilization Instruction - Ambu Aura40 Manual Del Usuario

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CAUTION
Handle the Ambu Aura40 carefully as it is made of silicone, which can be torn or punctured.
Avoid contact with sharp or pointed objects.
WARNING
Do not replace or disassembly any components of the Ambu Aura40 as is may cause
product failures.

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
CAUTION
Liquid in the inflation system may cause premature inflation valve failure.
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:
A) Manual cleaning
Wash the device thoroughly in water using a mild detergent until all adherent visible soil is
removed. It is recommended that the Ambu Aura40 is washed with neodisher® MediClean
forte (manufactured by Dr. Weigert). The working solution should be prepared by using 30 ml
of detergent per litre water. The Ambu Aura40 should be immersed in the working solution
and allowed to soak for 15 minutes.
CAUTION
All detergents should be used in the recommended dilution/concentration, temperature, water
quality (e.g., ph, hardness), and exposure (soak or contact) time, in accordance with the detergent
manufacturer's directions.
WARNING
Do not use germicides, disinfectants, or chemical agents such as glutaraldehyde, ethylene oxide,
phenol-based cleaners, iodine-containing cleaners or quaternary ammonium compounds to clean or
sterilize the Ambu Aura40. The material absorbs such substances, resulting in exposure of the patient
to potentially severe tissue burns and possible deterioration of the device. Do not use an Ambu Aura40
that has been exposed to any of these substances.
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492 4610 40 Aura40_V03_0810.indd 8-9
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.
B) Automated cleaning
After rinsing under cool running tap water soak the device in a mild detergent such as
Neodischer® MediClean forte (manufactured by Dr. Weigert) or Endozime® (manufactured by
Ruhof Corporation). Prepare the solution according to the manufacturer's instructions using
warm tap water and soak for 30 minutes.
After soaking place the devices in an automated washer.
The following automated cleaning procedure ahs been validated in a STERIS 444 washer
Phase
Recirculation time (minutes)
Water temperature
Pre-wash 1
2:00
Cold tap water
Enzyme wash
2:00
Hot tap water
Wash
2:00
66°C
Rinse 1
0:15
Hot tap water (60°C)
Table 4. Automated cleaning procedure
CAUTION
Effective cleaning must be carried out to achieve proper sterilization
After automated washing the device must be removed from the washer and dried with a soft
clean cloth. The lumen must be dried using filtered pressurized air.

5.1.2 Sterilization instruction

The only recommended sterilization method is steam autoclaving. Strictly adhere to the following
validated instruction to ensure proper sterilization and to prevent damage.
The manual vent must be in open position. The Ambu Aura40 should be placed in an appropriate
steam autoclave-proof bag before steam autoclaving. Ensure that the pack is large enough to
contain the device without stressing the seals.
Detergent type and concentration
N/A
Neodisher MediClean forte (5/8 fl�oz / gallon water; 38 ml / 5 litre
water)� Endozime (1 fl�oz / gallon water; 32 ml / 5 litre water)
Neodisher MediClean forte (5/8 fl�oz / gallon water; 38 ml / 5 litre
water)� Endozime (1 fl�oz / gallon water; 32 ml / 5 litre water)
N/A
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8/23/2010 1:21:24 PM

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