Ambu aView 2 Advance Instrucciones De Uso página 5

1. Important information – Read before use
Read these Instructions for Use carefully before using the Ambu® aView™ 2 Advance.
The Instructions for Use may be updated without further notice. Copies of the current version
are available upon request. The latest version is available on ambu.com. Please be aware that
the instructions do not explain or discuss clinical procedures. They describe only the basic
operation and precautions related to the operation of the Ambu® aView™ 2 Advance.
In these Instructions for Use, the term displaying unit refers to Ambu® aView™ 2 Advance.
The terms visualization device and endoscope are used interchangeably throughout the
document and refer to compatible Ambu endoscopes and other visualization devices that
can be connected to and used with the displaying unit.
These Instructions for Use apply only to the displaying unit. For information on a specific Ambu
visualization device, refer to the relevant Instructions for Use.
According to the Spaulding's/CDC classification, the displaying unit including the mounting
bracket is a non-critical device.
1.1. Intended use
The Ambu® aView™ 2 Advance is intended to display live imaging data from compatible Ambu
visualization devices.
1.2. Indications for use
As the aView™ 2 Advance is intended to display live imaging data from compatible Ambu
visualization devices, the intended medical indication will be defined by the connected
visualization devices.
1.3. Intended patient population
As the displaying unit is intended to display live imaging data from specific Ambu
visualization devices, the intended patient population will be defined by the connected
Ambu visualization device.
1.4. Intended user profile
Healthcare professionals trained on procedures with compatible visualization devices typically
assisted by other healthcare professionals and medical technicians with knowledge of setting
up medical devices.
1.5. Clinical benefits
In conjunction with a compatible single-use visualization device, the Ambu® aView™ 2 Advance
provides visualization and inspection of hollow organs and cavities in the body.
1.6. Contraindications
None known for the displaying unit.
1.7. Potential adverse events
None known for the displaying unit.
1.8. General notes
If during the use of this device or as a result of its use, a serious incident has occurred,
please report it to the manufacturer and to your national authority.
1.9. Warnings and cautions
Failure to observe these warnings and cautions may result in patient injury or damage to the
equipment. Ambu is not responsible for any damage to the equipment or patient injury
resulting from incorrect use.
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