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1. Important Information – Read Before Use
Read these safety instructions carefully before using the aView monitor. The Instruction 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
aView monitor.
1.1. Intended Use
The aView
monitor is a non-sterile, reusable digital monitor, intended to display live imaging
TM
data from Ambu visualisation devices.
1.2. 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.
aView images must not be used as an independent diagnostic of any pathology.Phy-
sicians must interpret and substantiate any finding by other means and in the light of
the patient's clinical characteristics.
2.
Do not use the aView monitor if it is damaged in any way or if any part of the func-
tional check fails.
3.
The aView is not to be used when delivering highly flammable anaesthetic gases to
the patient. This could potentially cause patient injury.
4.
The aView is not to be used in a MRI environment.
5.
Do not use aView during defibrillation.
6.
When handling the patient do not simultaneously touch the aView power socket or
docking connector.
7.
Always watch the live endoscopic image on the aView when advancing or withdraw-
ing a visualization device.
8.
To avoid risk of electric shock, this equipment must only be connected to a supply
mains with protective earth. To disconnect aView from mains remove the mains plug
from the wall outlet.
9.
Clean and disinfect the aView monitor after each use according to the instructions in
section 5. Disconnect aView from any mains power supply, remove any accessories
and make sure the aView is completely turned off before cleaning and disinfection.
10.
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 decreased electromagnetic immunity of this equipment and result in
improper operation.
11.
Electronic equipment and the aView may affect the normal function of each other. If
the aView is used adjacent to or stacked with other equipment, observe and verify
normal operation of both the aView and the other electronic equipment prior to
using it. It may be necessary to adopt procedures for mitigation, such as
reorientation or relocation of the equipment or shielding of the room in which
it is used. Consult the tables in appendix 1 for guidance in placing aView.
12.
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.
13.
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 system, including cables specified by the manufacturer. Otherwise,
degradation of the performance of this equipment could result.
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