Cleaning And Sterilization Recommendations; Functional Testing; Test 1 - Visual Inspection; Test 2 - Inflation/Deflation Test - Ambu Aura40 Manual Del Usuario

WARNING
The manual vent must be open prior packaging for sterilization to avoid irreparable damages to
the cuff and pilot balloon.
The following sterilization cycle according to AAMI TIR 12 is recommended.
Sterilizer type Preconditioning pulses
Gravity displacement N�A�
Dynamic air removal
3
(pre-vacuum)
Table 5. Parameters for gravity-displacement and dynamic air removal steam sterilization cycles.
The record card should be completed each time the Ambu Aura40 is sterilized.
After sterilization the Ambu Aura40 should be stored in accordance with accepted hospital
practice. The Ambu Aura40 should not be exposed to direct sunlight or elevated temperatures
during storage. Store in unopened pouches at temperature between 10ºC/50ºF and 25ºC/77ºF.

5.1.3 Cleaning and sterilization recommendations

Applicable methods Cleaning
 Applicable Manual
 Not applicable cleaning
Ambu Aura40
*
Table 6. Cleaning and sterilization recommendations
* Specific validated procedures described in 5.1.1
** Specific validated procedures described in 5.1.2

5.2. Functional testing

Functional testing as described below must be carried out before using the device. The tests
should be conducted in a manner consistent with accepted medical practice that minimizes
contamination of the Ambu Aura40 prior to insertion.
WARNING
• Do not use and destroy the device if any one test fails.
• Dispose of the Ambu Aura40 in a safe manner according to local guidelines of medical waste.
WARNING
Make sure the manual vent is closed during functional testing and clinical use
CAUTION
Always wear gloves during the preparation and insertion of the Ambu Aura40 to minimize
contamination. Make sure that the cuff protector has been removed from the cuff
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Minimum temperature Full cycle time Minimum dry time
135°C 10 Min� 30 Min�
135°C 3 Min� 30 Min�
Sterilization
Washing Gravity displacement Dynamic air removal
machine Steam sterilisation (pre-vacuum)
* ** **

5.2.1. Test 1 - Visual inspection

Closely examine the Ambu Aura40 for any damage, such as perforation, scratches, blockage,
loose parts, etc. Do not use the Ambu Aura40 if it is damaged in any way.
WARNING
Do not use the Ambu Aura40 if the mask connector does not fit tightly into the outer end of the
airway tube.
Do not use the Ambu Aura40 if the manual vent does not fit tightly or is disconnected from the pilot balloon.
Check that the airway connector on the Ambu Aura40 is fitted tightly to the airway tube.
Ensure that it cannot easily be pulled off. Do not twist the connector as this may break the seal.
Closely examine the pilot balloon for any damages and make sure that the manual vent fit tightly.

5.2.2. Test 2 - Inflation/deflation test

Make sure that the manual vent is closed prior to carrying out this test. Ambu recommends
deflating the cuff of the Ambu Aura40 completely. Once deflated, check the cuff thoroughly
for any wrinkles or folds. Over-inflate the cuff to the appropriate volume as specified in Table 7.
Check that the inflated cuff is symmetrical and smooth. There should not be any bulge nor
any sign of leakage in the cuff, pilot tubing or pilot balloon.
WARNING
Do not use the Ambu Aura40 if there are any bulges on the cuff or if there are any signs of leakage.
#1 #1½ # 2
Over-inflation
6 ml 10 ml 15 ml
Cuff volumes
Table 7. Test cuff over-inflation volumes for the Ambu Aura40
CAUTION
The inflation volumes specified in table 7 are for testing purposes only. These volumes are not to be used
during normal use of the device – the recommended standard inflation volumes can be found in Table 1.
Mask Size
#2½ # 3 # 4 # 5 # 6
21 ml 30 ml 45 ml 60 ml 75 ml
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