EKO DUO Manuel De L'utilisateur page 4

1.4
Caution
CAUTION
•
To reduce the risk of device interference, keep
DUO at least 2 meters away from all RF emitters
including Wifi routers and radios when operating
or charging.
•
To reduce the risks associated with infection
follow all cleaning and disinfecting instructions
included in this manual. Establish and follow a
cleaning and disinfecting schedule after each use.
•
To reduce the risks associated with inaccurate
data acquisition store and operate this device only
as instructed in this manual. It is recommended
that the battery be recharged within thirty minutes
of the LED indicator turning red. Recharge the
battery using only the wireless charging pad
provided with the device.
•
DO NOT immerse the device in a liquid or subject
it to any sterilization processes other than those
described in this manual. The device is non-sterile.
•
To reduce the risks associated with very strong
electromagnetic fields avoid using the device
near strong radio frequency (RF) signals or
portable and/or mobile RF devices. If sudden
or unexpected sounds are heard, move away
from any radio transmitting antennas. Using
accessories, transducers, and cables not
produced by Eko may result in increased RF
emissions or decreased immunity of DUO.
•
Please read, understand, and follow all safety
information contained in these instructions prior
to using DUO. It is recommended that these
instructions be retained for future reference.
•
DUO contains a Bluetooth Class 2 wireless
data link. The maximum radio frequency field
strength generated by the device is below three
volts per meter, a level that is considered safe to
use with other medical devices. However, audio,
video, and other similar equipment may cause
electromagnetic interference. If such devices are
encountered and cause interference, immediately
move DUO away from that device and/or turn the
Bluetooth feature OFF.
•
To reduce the risks associated with
environmental contamination follow applicable
regulations when disposing of this device. DUO
contains a rechargeable battery; please properly
dispose of the device as mandated by local
directives.
•
No modification of this equipment is allowed.
There are no repairable parts inside DUO.
•
Disperse any static electricity before using the
unit.
•
Warning: MR-unsafe! Do not expose the device
to a magnetic resonance (MR) environment. The
device may present a risk of projectile injury due
to the presence of ferromagnetic materials that
can be attracted by the MR magnet core. Thermal
injury and burns may occur due to the metal
components of the device that can heat during
MR scanning. The device may generate artifacts
in the MR image. The device may not function
properly due to the strong magnetic and radio
frequency fields generated by the MR scanner.
•
This device does not detect or measure all heart
rate, heart rhythm and heart waveform changes.
•
The device has not been tested for use on infants
weighing less than 10kgs.
•
Conductive parts of electrodes and associated
connectors for Type BF Applied Parts, including
the neutral electrode, should not contact other
conductive parts including earth.
•
Do not use DUO while it is charging.
•
Do not use on patients with cardiac pacemakers
or other electronic implanted devices.
•
Do not use the DUO on a portion of the body with
too much body fat, body hair or very dry skin, a
successful recording may not be possible.
•
Do not use DUO while charging your mobile
device, this will cause electrical interference with
the ECG signal.
•
Do not store the DUO in extremely hot, cold,
humid, or wet conditions.
•
Do not expose to strong electromagnetic fields.
•
Do not use as sole basis for medication or
treatment decisions.
•
Do not take a recording if the electrodes are dirty.
Clean them first.
•
Do not use the DUO over broken skin or wound
areas.
P.
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