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M-170DFU00-20 - V7 - Mise en activité le 01/08/2024
C
ONTENTS
Product description ........................................................................................................................................................... 4
Presentation of the system .............................................................................................................................................. 8
Installation ....................................................................................................................................................................... 11
Device configuration ....................................................................................................................................................... 14
Use .................................................................................................................................................................................... 22
Cybersecurity ................................................................................................................................................................... 27
In case of problems ........................................................................................................................................................ 27
Cleaning and maintenance .............................................................................................................................................. 32
Transport of the device .................................................................................................................................................. 34
Technical characteristics ............................................................................................................................................... 35
EC Marking ....................................................................................................................................................................... 42
End of life disposal of the device ................................................................................................................................... 42
Néa
Manuel patient NEA Anglais
Intended purpose .................................................................................................................................................. 4
Indications ............................................................................................................................................................. 4
Contra-indications ................................................................................................................................................ 4
Warnings/Precautions ......................................................................................................................................... 5
Potential undesirable side effects ..................................................................................................................... 7
Target patient groups .......................................................................................................................................... 7
Intended users ...................................................................................................................................................... 7
Environment of use .............................................................................................................................................. 7
Clinical benefits ..................................................................................................................................................... 7
Essential performance of the device ................................................................................................................ 7
List of authorized accessories ........................................................................................................................... 8
Views of the device .............................................................................................................................................. 9
Meaning of symbols ............................................................................................................................................ 9
Standard installation .......................................................................................................................................... 11
Re-installation of the side cover ...................................................................................................................... 12
Installation with cigarette lighter (optional) ................................................................................................... 12
Filling the tank (if applicable)............................................................................................................................ 13
Filter installation ................................................................................................................................................. 13
User interface description ................................................................................................................................. 14
Features of the device ....................................................................................................................................... 16
How to set the device ........................................................................................................................................ 17
Starting treatment .............................................................................................................................................. 22
Stopping treatment ............................................................................................................................................ 22
Use when oxygen is added (optional) ............................................................................................................. 22
Use of the SD card .............................................................................................................................................. 23
Use of the ModCom or ModCom+ (optional) ............................................................................................... 24
Helpful tips ........................................................................................................................................................... 27
Device Messages................................................................................................................................................ 29
Error messages ................................................................................................................................................... 31
Daily ....................................................................................................................................................................... 32
Weekly .................................................................................................................................................................. 32
Monthly ................................................................................................................................................................. 33
Pre-transport precautions ................................................................................................................................. 34
Air travel ............................................................................................................................................................... 34
Performance of the device ............................................................................................................................... 35
Humidifier performance .................................................................................................................................... 35
Conditions of use ................................................................................................................................................ 36
Transport and storing conditions .................................................................................................................... 36
Electrical characteristics ................................................................................................................................... 36
Physical characteristics .................................................................................................................................... 37
Electromagnetic compatibility ......................................................................................................................... 37
Special characteristics according to the standard ISO 80601-2-70:2020 ............................................... 39
Functional diagram of the internal pneumatic circuit ................................................................................. 41
Special characteristics according to the standard ISO 80601-2-74 ......................................................... 42
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