Electromagnetic Compatibility; Operating Conditions; Storage Conditions; Spare Parts - Air Liquide Soffio plus Manual Del Usuario

8 - ELECTROMAGNETIC COMPATIBILITY

This device complies with the requirements of IEC EN 60601-1-2:2015 on the electromagnetic compatibility of medical devices.
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.
The SOFFIO PLUS aerosol therapy device is designed to operate in an electromagnetic environment where radiated RF disturbance is
under control. The customer or user of the SOFFIO PLUS aerosol therapy device can help prevent electromagnetic interference by lea-
ving a minimum distance between mobile and portable RF communication devices (transmitters) and the SOFFIO PLUS aerosol therapy
device. The table below shows the recommended distances for the SOFFIO PLUS aerosol therapy device based on the maximum output
of the radio communication devices.
Nominal maximum transmit-
ter output [W]
0.01
0.1
1
10
100
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 apparatus, 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.
12 - 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 apparatus 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 refers only to the SOFFIO PLUS and to no other devices.
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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ENGLISH • ENGLISH • ENGLISH • ENGLISH • ENGLISH • ENGLISH •
RECOMMENDED DISTANCES BETWEEN RADIO-COMMUNICATION DEVICES
150 kHz to 80 MHz
d = 1,2 x √P
0,12
0,38
1,2
3,8
12
Separation distance [m] at the transmitter frequency
80 MHz to 800 MHz
d = 1,2 x √P
0,12
0,38
1,2
3,8
12
800 MHz to 2.5 GHz
d = 2,3 x √P
0,23
0,73
2,33
7,3
23