Lenire Tinnitus Manuel D'utilisation page 18

Section E
Technical Information
The following section outlines technical information pertaining
to the Lenire device. This information is included in order to
conform to international safety standards for medical devices.
There is also important information included in the following
section relating to environmental operating conditions and use
in the vicinity of other electrical devices such as mobile phones.
Chapter 23 - Environmental Operating Conditions
Lenire should only be used in environments between 5 and 40 degrees
Celsius, relative humidity between 15% and 93%, and atmospheric
pressure of between 700 and 1060 hPa. This precludes the use at
altitudes above 3000m, unless traveling in an airplane that has the
cabin pressurised.
Chapter 24 - Radio Frequency (RF) Specications
The Lenire Controller contains a Bluetooth wireless radio module
that transmits the sound stimulus to the Headphones. If the wireless
communication is adversely aected, for example due to obstruction
or interference, gaps in sound stimulus may occur. If this should occur
during treatment, please try the following:
• Move to a location where likely sources of interference are at
least 2 meters (6½ feet) away from the Controller, Tonguetip and
Headphones. Likely sources of interference include microwave
ovens, Wi-Fi routers, smart watches and mobile phones.
• Ensure there is line-of-sight between the Controller and the
Headphones.
• Increase the distance between the Controller and the Headphones.
While this may seem counter-intuitive, the Bluetooth system
automatically increases the signal power as this distance is increased
which may reduce or eliminate gaps in the sound stimulus.
The Bluetooth radio specications are as follows:
Specication
Frequency Band
Modulation
Operating Range (Line-of-Sight) ≥ 10 meters
RF Sensitivity
Eective Radiated Power (ERP)
Page 16
Description
2.4 GHz to 2.4835 GHz
8 DPSK, PI/4 DQPSK, GFSK
0.1% BER at -88dBm
<4dBm (2.5 mW) Bluetooth Class 2
Chapter 25 - Guidance and Declaration for Electromagnetic
Compatibility
The Lenire Controller, Tonguetip and the Charger have been tested
for electromagnetic performance to the requirements of IEC 60601-1-2
which includes testing to the following standards:
• IEC 61000-4-3 (Radiated electromagnetic elds)
○ To 80 MHz to 2.7 GHz at 10 V/m
○ 2.7 GHz to 6 GHz at 3 V/m
○ Spot frequencies per IEC 60601-1-2:2014 Table 9 at up to 28 V/m
• IEC 61000-4-6 (Conducted electromagnetic elds)
○ 150 kHz to 80 MHz at 3V
○ Spot frequencies per IEC 60601-1-2:2014 at 6 V
• IEC 61000-4-2 (Electrostatic Discharge)
○ +/- 8 kV Contact Discharge
○ +/- 15 kV Air Discharge
• IEC 61000-4-8 (50 Hz/60 Hz magnetic elds) at 30 A/m
• IEC 61000-4-4 (Electrical Fast Transients)
• IEC 61000-4-5 (Surge)
• IEC 61000-4-11 (Voltage dips and interruptions)
Disturbances higher than these limits are unlikely to be encountered
in the home or professional healthcare environments. Electromagnetic
interference may result in temporary disruption of the sound stimulus
(manifesting as brief gaps of silence) as described in Chapter 25.
In addition, the Headphones have been tested to the requirements of
CISPR 35 (EN 55035), which includes testing to the following standards:
• IEC 61000-4-3 (Radiated electromagnetic elds)
○ 80 MHz to 1 GHz at 3 V/m
○ 1.8 GHz, 2.6 GHz, 3.5 GHz and 5 GHz at 3 V/m
• IEC 61000-4-2 (Electrostatic Discharge)
○ +/- 4 kV Contact Discharge
○ +/- 8 kV Air Discharge
The Lenire device is intended for use in the home
healthcare and professional healthcare environments
only. The performance of the Lenire in environments with
high electromagnetic disturbances, e.g. near magnetic
resonance imaging (MRI) or high frequency surgical
equipment has not been evaluated and the Lenire should
not be used in such environments.
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