13
en
Sterilizer Type
Pre-vacuum
Pre-vacuum
Gravity
Gravity
Preconditioning Pulses
3
3
N/A
N/A
Temperature
132 °C
134 °C
134 °C
135 °C
Fully Cycle Exposure Time
04 minutes
03 minutes
10 minutes
10 minutes
Dry Time
20 minutes
20 minutes
20 minutes
30 minutes
Test Article Configuration
Individually single pouched in a 7.5" x 13" self-sealed pouch and
placed on edge in the sterilizer
Table 5. Sterilization parameters
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 10 °C / 50 °F and 25 °C / 77 °F.
5.1.3. Cleaning and sterilization recommendations
Applicable methods
Cleaning
Sterilization
Applicable
Not applicable
Manual
cleaning
Washing
machine
Gravity
displacement
Steam sterilisation
Dynamic air removal
(pre-vacuum)
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.
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.
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.
