Gima 35134 Manuel De L'utilisateur page 223

Electromagnetic compatibility
Levels of compliance with the EN 60601-1-2:2015 standard
- ESD immunity 15kV for air discharge 8 kV for contact discharge (EN 61000-4-2)
- 2kV/100kHz burst immunity (EN 61000-4-4) power supply/1kV signals
- Surge immunity (EN 61000-4-5): 1kV common/2kV differential
- Magnetic field (EN 61000-4-8): 30A/m
- Dip Immunity: 0% 0.5 cycles; 0% 1 cycle; 70% 25 cycles (50Hz) and 30 cycles (60Hz);
Breaks: 250 cycles (50Hz); 300 cycles (60Hz)
- Immunity to RF currents in the range 150kHz-80MHz (EN 61000-4-6) 3V modulation 80% 1kHz
6V modulation 80% 1kHz for the following frequency ranges:
6.765 MHz ÷ 6.795 MHz
13.553 MHz ÷ 13.567 MHz
26.957 MHz ÷ 27.283 MHz
40.66 MHz ÷ 40.70 MHz
- CISPR 11 class A emissions
- EN 61000-3-2 class A Harmonic currents
- PST, DT, DC Flickers
Field (V/m)
3
27
28
9
28
28
28
9
WARNINGS:
Even though it complies with EN 60601-1-2, the medical device (DEVICE NAME) may interfere with other
appliances nearby. The device should not be used next to or stacked with other equipment. Install the device
away from other equipment which radiates high frequencies (short waves, microwaves, electrosurgical units,
mobile phones).
The use of this device near to or placed on other appliances should be avoided, as this can lead to its incorrect
operation. In these cases, the device and the other equipment should be kept under observation to verify their
normal operation.
Transportable RF communications equipment (including peripherals such as antenna cables and external
antennas) should be used no less than 30 cm (12 inches) away from any part of the [EM EQUIPMENT or EM
SYSTEM], including the cables specified by the MANUFACTURER. Otherwise, performance degradation of
this equipment may occur"
The device is designed to operate in an electromagnetic environment in which RF radiated disturbances are
under control. The customer or the operator can help prevent electromagnetic interference by ensuring a mini-
mum distance between mobile and portable RF communication devices (transmitters) and the medical device,
as recommended below, in relation to the maximum output power of the radio communication devices.
Operator's Manual for Patient Monitor
RF field immunity (EN 61000-4-3):
Frequency
80MHz ÷ 2700MHz
380MHz ÷ 390MHz
430MHz ÷ 470MHz
704MHz ÷ 787MHz
800MHz ÷ 960MHz
1700MHz ÷ 1990MHz
2400MHz ÷ 2570MHz
5100MHz ÷ 5800MHz
98
Modulation
1kHz AM 80%
18Hz PM 50%
18Hz PM 50%
217Hz PM 50%
18Hz PM 50%
217Hz PM 50%
217Hz PM 50%
217Hz PM 50%