Contraindications; System Description - Ambu aView 2 Advance Bedienungsanleitung

1. Important Information – Read Before Use
Read these safety instructions carefully before using the Ambu
tion for Use may be updated without further notice. Copies of the current version are availa-
ble upon request. The latest version of the Instructions for Use is available on www.ambu.com.
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 aView 2 Advance.
In this Instruction for Use, the term displaying unit refers to aView 2 Advance. This Instruction for
Use applies to the displaying unit. For information on a specific Ambu visualization device refer to
the relevant Instruction 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 displaying unit is a non-sterile, reusable monitor, intended to display live imaging data from
Ambu visualization devices.
1.2. Indications for Use
Please refer to the Instructions for Use of the compatible Ambu visualization devices for
information on the indications for use.
1.3 Contra Indications
None known for the displaying unit.
1.4. 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 system or patient injury resulting from
incorrect use.
WARNINGS
1. Use of accessories, transducers and cables other than those specified or provided by the
manufacturer of this equipment could result in increased electromagnetic emissions or de-
creased electromagnetic immunity of this equipment and result in improper operation.
2. 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.
3. To minimize risk of contamination, clean and disinfect the displaying unit after each use in
accordance with section 5.
4. Do not use the displaying unit if it is damaged in any way or if any part of the functional
check described in section 4.2 fails.
5. Portable 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 sys-
tem, including cables specified by the manufacturer. Otherwise, degradation of the perfor-
mance of this equipment could result.
6. To avoid risk of electrical shock only connect ancillary equipment, which are approved as
medical electrical equipment.
7. To avoid risk of electric shock, this equipment shall only be connected to a supply main with
protective earth.
8. 8. Use of this equipment adjacent to or stacked with other equipment should be avoided
because it could result in improper operation. If such use is necessary, this equipment and
the other equipment should be observed to verify that they are operating normally.
9. To avoid risk of electric shock do not touch the aView 2 Advance stand, VESA mount or video
out connectors while simultaneously handling the patient.
10. Only use spare parts supplied by Ambu. Do not modify the spare parts.
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® aView ™ 2 Advance. The Instruc-
CAUTIONS
1. Have a suitable backup system readily available for immediate use so the procedure can
be continued if a malfunction should occur.
2. To prevent damaging the device, do not cover the ventilation holes. This could lead to
a high surface temperature.
3. Using high frequency tools in a connected visualization device may affect the live
image. This is not a malfunction. Wait a few seconds for image to reset.
If as a result of its use, a serious incident has occurred, please report it to the manufacturer and
to your national authority.
1.5. Adverse Events
None known for the displaying unit.

2. System Description

The displaying unit is reusable. It can be connected to a range of Ambu visualization devices to
display video images. (see section 2.2 for compatible devices).
2.1. Displaying Unit Parts
Ambu aView Item number:
® ™
2 Advance
405011000
(SW versuibs v1.XX)
For aView 2 Advance model no., please check the label on the back of the displaying unit.
aView 2 Advance is not available in all countries. Please contact your local Ambu representative.
Power supplies
Ambu ® aView
x5
manufacturer: FSP Group Inc.
Ambu aView
®
part number: FSP065M-DBA
2.2. Compatible Devices
Compatible Ambu visualization devices
Ambu aScope 4 Broncho
® ™
Ambu ® aScope ™ 4 RhinoLaryngo
The listed devices may not be available in all countries. Please contact your local Ambu representative.
Please refer to the Instruction for Use of the relevant visualization device.
Bracket (e.g. for atta- Item number:
ching the monitor to
an I.V. pole)
405013100
Item number:
™ 2 Advance power supply EU/CH
405015300 (not
2 Advance power supply DK & UK)
™
UK 405015400
DK 405015500
AUS & NZ
405015100
US 405015200
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