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1. Important information – Read before use
Read these safety instructions carefully before using the Ambu® Aura40.
The instructions for use may be updated without further notice. Copies of the current version are
available upon request. Please be aware that these instructions do not explain or discuss clinical
procedures. They describe only the basic operation and precautions related to the operation of the
Ambu® Aura40.
Before initial use of the Ambu® Aura40, it is essential for operators to have received sufficient
training in using the product and to be familiar with the intended use, warnings, cautions, and
indications mentioned in these instructions.
1.1. Warnings/Cautions
Throughout these directions for use, appropriate warnings are given describing potential safety
hazards associated with use of the Ambu® Aura40.
WARNING
The user should be familiar with the following warnings prior to use of the Ambu® Aura40.
1. The Ambu® Aura40 is delivered non-sterile and must be cleaned and sterilized before initial
use and before each subsequent use.
2. Lubricate only the posterior tip of the cuff to avoid blockage of the airway aperture or
aspiration of the lubricant.
3. To avoid trauma, do not use force at any time during insertion of the Ambu® Aura40.
4. Adhere strictly to the recommended cuff inflation volumes as specified in Table 1. Never
over-inflate the cuff after insertion.
5. In case the Ambu® Aura40 is used in a fasted patient who may have retained gastric contents,
measures should be taken to empty the stomach contents and administer appropriate
antacid therapy. Examples include, but are not limited to, moderate obesity and hiatal hernia.
6. In patients with severe oropharyngeal trauma, the Ambu® Aura40 should only be employed
when all other attempts to establish an airway have failed.
7. Use of a nasogastric tube may make regurgitation likely because the tube may interfere
with the function of the lower oesophageal sphincter.
8. The Ambu® Aura40 is flammable in the presence of lasers and electrocautery equipment.
9. Do not replace or disassemble any components of the Ambu® Aura40 as is may cause
product failures.
10. 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.
11. The manual vent must be open prior packaging for sterilization to avoid irreparable
damages to the cuff and pilot balloon.
12. Do not use and destroy the device if any one test fails.
13. Dispose of the Ambu® Aura40 in a safe manner according to local guidelines of medical waste.
14. Make sure the manual vent is closed during functional testing and clinical use.
15. Do not use the Ambu® Aura40 if the mask connector does not fit tightly into the outer end
of the airway tube.
16. Do not use the Ambu® Aura40 if the manual vent does not fit tightly or is disconnected from
the pilot balloon.
17. Do not use the Ambu® Aura40 if there are any bulges on the cuff or if there are any signs
of leakage.
