8 - ELECTROMAGNETIC COMPATIBILITY
This device complies with the requirements of IEC 60601-1-2:2015 on the electromagnetic compatibility of medical devices. This includes
immunity to radiofrequency electric fields and electrostatic discharge as well as all the applicable requirements of the standards.
Compliance with electromagnetic compatibility standards does not guarantee total immunity of the product. Some devices (mobile
phones, pagers, etc.) may interrupt operation if used near medical devices.
RECOMMENDED DISTANCES BETWEEN RADIO-COMMUNICATION DEVICES
The MOBYNEB aerosol therapy device is designed to operate in an electromagnetic environment where radiated RF disturbance is
under control. The customer or user of the MOBYNEB aerosol therapy device can help prevent electromagnetic interference by leaving
a minimum distance between mobile and portable RF communication devices (transmitters) and the MOBYNEB aerosol therapy device.
The table below shows the recommended distances for the MOBYNEB aerosol therapy device based on the maximum output of the
radio communication devices.
Nominal maximum
transmitter output [W]
Separation distance [m] at the transmitter frequency
150 kHz to 80 MHz
d = 1,2 x √P
80 MHz to 800 MHz
d = 1,2 x √P
800 MHz to 2.5 GHz
d = 2,3 x √P
0,01
0,12
0,12
0,23
0,1
0,38
0,38
0,73
1
1,2
1,2
2,33
10
3,8
3,8
7,3
100
12
12
23
The recommended separation distance d in metres [m] for transmitters with a nominal maximum transmitter output not shown in the
table can be calculated using the equation applied to the transmitter frequency, where P is the nominal maximum transmitted output
in Watt [W] declared by the manufacturer.
Note 1. For 80 MHz and 800 MHz, apply the distance for the higher frequency interval.
Note 2. These guidelines may not apply in all situations. Electromagnetic propagation is influenced by the absorption and reflection
of structures, objects and persons.
9 - OPERATING AND STORAGE CONDITIONS
9.1 - OPERATING CONDITIONS
- Temperature range +5°C to +40°C
- Relative humidity 15% to 93%
- Atmospheric pressure 700 hPa to 1060 hPa
9.2 - STORAGE CONDITIONS
- Temperature range -25°C to +50°C
- Relative humidity less than 93%
- Atmospheric pressure 700 hPa to 1060 hPa
10 - SPARE PARTS
Only original spare parts must be used.
11 - WARRANTY CONDITIONS
The manufacturer is liable for the safety, reliability and performance of the device, provided that it is used in accordance with the
instructions and for the intended purpose only, and any repairs are carried out by the manufacturer or an approved service centre.
The manufacturer declines all liability and the warranty will be invalidated if the user fails to follow the instructions and the important
notes contained herein.
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TECHNICAL
UPDATES
Air Liquide Medical Systems S.r.l. periodically reviews and modifies all its medical devices in order to improve their performance, safety
and reliability. The instruction booklets are updated accordingly to include any new or changed features.
If the booklet accompanying the device gets damaged or mislaid, a replacement copy can be obtained from the manufacturer by quoting
the data shown on the rating plate.
13 - COPYRIGHT
The information contained in this booklet must not be used for any purpose other than the reason for which it is provided.
This booklet is the property of Air Liquide Medical Systems S.r.l. and no part of it may be reproduced without the manufacturer’s written
permission. All rights reserved.
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