Service Life; Environmental Conditions For Use; Environmental Conditions For Storage And Transportation; Electrical Safety Information - Bayer HealthCare Breelib Instructions For Use Manual

Inhalation system
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11. TEChNICAL DATA

11.4. Service Life

The Breelib™ is intended for repeated use. The service life of the
components is given in the following table:
Component
Base unit
Nebuliser unit and mouthpiece
At the end of the service life, replacement is recommended to
ensure full device functionality. In the event of visible damage
or a noticeably longer nebulisation time per treatment, the
nebuliser unit must be replaced immediately.

11.5. Environmental Conditions for Use

The following table describes the ambient conditions required
for the use of the Breelib™.
Ambient temperature
0 to 40°C
Humidity range
35-85% RH, non-condensing
Ambient pressure
700 hPa to 1060 hPa
In the event of extreme fluctuations of the ambient
temperature, the device can malfunction due to condensation.
11.6. Environmental Conditions for Storage and
Transportation
Caution
RIf your device is left inside a closed vehicle, temperatures up
to 80°C can be reached. Do not expose your device to direct
sunlight for extended periods of time (for example on the
dashboard of a car).
86886863_01.indd 36
Service life
2 Years after 1
use
st
1 Month after 1
use
st
Packaging Technology Berlin SGQWX
client: 0021,GVDE
material-no.: 86886863
Reference-Code: 08CN0109
name: LF-BRO-Breelib Inhaler Starter Kit
colors:
Black /
cyan /
magenta /
yellow
version: 28.03.2019/01
Restricted Document
Ambient temperature during
transport
Ambient temperature during
storage

11.7. Electrical Safety Information

Essential performance is defined according to IEC 60601-1 to be
"performance necessary to achieve freedom from unacceptable
RISK".
Considering the intended use of the device, essential
performance is not applicable to the Breelib™ Inhalation
System.

11.8. Radio Frequency Information

Frequency band
Operating Frequency
Modulation
Nominal Output Power
The Breelib™ may be affected by portable or mobile RF (radio
frequency) communication equipment, like mobile phones or
computer equipment. In case of malfunction, increase the
distance from portable or mobile RF communication
equipment.
Detailed information is provided in chapter
"11.9. Electromagnetic Compatibility" on page 37.
36
page: 36
Bayer AG
PZ: 2780A-2
code-no.:
IFU date: 210319
country: GB/-/-
dimension: 210 x 148 mm
-10 to 35 °C
Humidity: 35-85% RH
-10 to 35 °C
Humidity: 35-85% RH
2.4 GHz ISM band
2400 to 2483.5 MHz
Frequency Hopping Spread
Spectrum (FHSS) (GFSK)
Max. 4 dBm
3/28/2019 11:16:43 AM

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