1. Important Information – Read Before Use
Read the Instructions for Use carefully before using the Ambu® aBox™ 2. 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® aBox™ 2.
In the 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/Indications for Use
The aBox 2 is intended to display live imaging data from compatible Ambu visualization
devices.
1.2. 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.
1.3. 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.
1.4. 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.
1.5. Contraindications
None known for the displaying unit.
1.6. 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.
WARNINGS
1. To avoid patient injury during procedure, be careful to check whether the image on
the screen is a live image or a recorded image and verify that the orientation of the
image is as expected.
2. To minimize risk of contamination, always wear gloves during handling of the
displaying unit and ensure that the displaying unit is cleaned and disinfected before
and after each use in accordance with chapter 9.
3. Portable radio frequency (RF) communications equipment (including peripherals
such as antenna cables and external antennas) should be used no closer than 30 cm
(12 inches) to any part of the displaying unit and the attached visualization device,
including cables specified by the manufacturer. Otherwise, this could result in
degradation of the performance of this equipment.
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