Important Information - Read Before Use; Intended Use; Indications For Use; Intended Patient Population - Ambu aBox 2 Instrucciones De Uso

1. Important Information – Read Before Use
Read these Instructions for Use carefully before using the Ambu® aBox™ 2. These 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® aBox™ 2.
In these Instructions for Use, the term displaying unit refers to Ambu® aBox™ 2. 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

1.1. Intended use

The aBox™ 2 is intended to display live imaging data from compatible Ambu visualization devices.

1.2. Indications for use

As the aBox™ 2 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 devices.

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® aBox™ 2 provides
visualization and inspection of hollow organs and cavities in the body.

1.6. Potential adverse events

None known for the displaying unit.

1.7. 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.

1.8. Contraindications

None known for the displaying unit.

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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