Caution - Eko DUO Benutzerhandbuch

1.5 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.
• 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 of the
interfering device 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.
• N o 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.
DUO - User Manual Pg 4
• 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.
• If used on a portion of the body with significant
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 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, according to the cleaning
instructions in this User Manual.
• Do not use DUO over broken skin or wound
areas.