What To Do In The Event Of An Incident; Warranty And Limits Of Liability; Ce Declaration Of Conformity For Medical Devices - ARCHEON EOlife Instructions D'utilisation

Manufacturer statement and guidance – Electromagnetic immunity
EOlife® is designed to operate in an electromagnetic environment as defined below The user should ensure that the
device is used in such an environment
Immunity tests IEC 60601 test level
Contact: ±8kV
Electrostatic discharge (ESD)
according to IEC 61000-4-2
Air: ±2kV ±4kV, ±8kV, ±15kV
Access by power
Electrical fast transients/bursts
AC/DC:
according to IEC 61000-4-4
± 2 kV, f = 100 kHz
Shock waves/surges according Access by AC/DC power ports:
to IEC 61000-4-5 ± 0 5 kV, ±1 kV (Line/Line)
Min & max voltage:
Voltage dips, short 0% UT for 0 5 cycle
interruptions and voltage 0% UT for 1 cycle
variations according to IEC 70% UT for 25/30 cycles
61000-4-11
0 % UT for 250/300 cycles
Access by AC/DC power ports:
Conducted disturbances 3 V (0 15 MHz to 80 MHz)
according to IEC 61000-4-6 6 V (+ ISM bands)
80% MA, 1 kHz
Power frequency magnetic 30 A/m
field according to IEC 61000-4-8 50 Hz or 60 Hz
80 MHz to 2 7 GHz
Radiated disturbances AM modulation 80%, f = 1 kHz
according to IEC 61000-4-3
10 V/m: Home
EOlife® has been tested for immunity to the radio services listed below If the field strength measured on the site where
EOlife® is used exceeds the level of compliance below, it is advisable to monitor EOlife® to ensure that it is functioning
properly If this is not the case, it may be necessary to take additional measures, such as changing the direction or
location of EOlife®
380 to 390 MHz
27 V/m; PM 50%; 18 Hz
430 to 470 MHz
28 V/m; (FM ± 5 kHz, 1 kHz sin)
PM; 18 Hz
704 to 787 MHz
9 V/m; PM 50%; 217 Hz
Proximity fields from RF
wireless communications
800 to 960 MHz
equipment according to IEC
28 V/m; PM 50%; 18 Hz
61000-4-3
1700 to 1990 MHz
28 V/m; PM 50%; 217 Hz
2400 to 2570 MHz
28 V/m; PM 50%; 217 Hz
5100 to 5800 MHz
9 V/m; PM 50%; 217 Hz
50
Level of compliance
Contact: ±8 kV
Air: ±15 kV
5/50 ns, 100 kHz; ±2 kV
1 2/50 (8/20) μs LtL: ±1 0 kV
0% UT for 0 5 cycle (1 phase)
0% UT for 1 cycle
70% UT for 25/30 cycles
0% UT for 250/300 cycles (50/60 Hz)
150 kHz – 80 MHz 3 V
ISM/amateur bands 6 V
80% / 1 kHz
other as defined in RMF
30 A/m 45
50 Hz or 60 Hz
80 MHz to 2 7 GHz
Home Healthcare 10 V/m Prof Healthcare 3 V/m
80% / 1 kHz
other as defined in RMF
380 to 390 MHz
27 V/m; PM 50%; 18 Hz
430 to 470 MHz
28 V/m; (FM ±5 kHz, 1 kHz sine) PM; 18 Hz
704 to 787 MHz
9 V/m; PM 50%; 217 Hz
800 to 960 MHz
28 V/m; PM 50%; 18 Hz
XI. What to do in the event of an incident
If there is a persistent problem or a major adverse event occurs when using EOlife® (e g battery problem or sudden device
failure), ask your approved distributor what procedure to follow
Any incident occurring with the EOlife® product must be reported to the manufacturer, which must inform the Competent
Authority
XII. Warranty and limits of liability
1.
The manufacturer guarantees that the EOlife® device was manufactured in accordance with the technical
specifications, good manufacturing practices and other industrial standards and applicable regulations
2. The manufacturer undertakes to replace or refund any EOlife® product with hidden defects before the warranty
expires, providing that it receives the lot/serial number of the defective product
3. This warranty supersedes any other written or oral, express or implied, statutory or other guarantee, and no
commercial or other warranty that differs from this one will be applicable The only legal remedy in the event of
manufacturing defects is the warranty provided above This warranty does apply in the event of loss, damage,
injury or expenses incurred directly or indirectly linked to the use of EOlife®
4. The manufacturer is released from any responsibility in the event of misuse or improper handling, non-
compliance with warnings and instructions, damage occurring after EOlife® is offered for sale, or for any other
guarantee given by approved distributors
5. The manufacturer's warranty is valid for the following periods:
Product
EOlife® electronic unit
Battery
Charger
6. The manufacturer is ARCHEON, 2 Chemin des Aiguillettes, 25000 Besançon, France
XIII. CE declaration of conformity for medical devices
ARCHEON hereby declares that the product complies with the relevant provisions of Regulation (EU) 2017/745 on
medical devices
The full text of the declaration of conformity is available on the internet at www archeon-medical com
Warranty period
2 years
2 years
2 years
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