Electromagnetic Compatibility (Emc) - DTF MEDICAL kitett Fisio Pro Notice D'utilisation

Electro medical devices require special precautions against EMC and must be installed and set to operate in
accordance with the EMC information provided in this manual.
WARNING: Avoid using this unit near or stacked onto other equipment as this may cause a malfunction. If this
is necessary, this appliance and the other appliances should be monitored for normal operation.
WARNING: Use of accessories, transducers and cables other than those specified or supplied by the
manufacturer of this device may cause an increase in electromagnetic emissions or a decrease in the
immunity of this device and cause improper operation.
WARNING: Portable RF communication devices (including peripherals such as antenna cables and external
antennas) should not be used closer than 12 inches (30 cm) to any part of the FISIO® PRO breast pump,
including cables specified by the manufacturer. Otherwise, performance may be impaired.
WARNING: If the device malfunctions due to electromagnetic disturbances, the performance of the device
may be impaired and result in delayed patient care.
Wireless communication devices such as wireless home networking devices, mobile phones, cordless phones
and their bases, walkie-talkies can affect the device, and it is recommended to keep them at a distance of at
least 0.5 m from the device.
Emissions test
RF emissions (CISPR 11)
RF emissions (CISPR 11)
Harmonic emissions (IEC 61000-3-2)
Voltage fluctuations / flicker emissions (IEC 61000-3-3)
Immunity test
Electrostatic discharge (ESD)
(IEC 61000-4-2)
Electrical fast transient / burst
(IEC 61000-4-4)
Surge
(IEC 61000-4-5)
Voltage dips, short interruptions
and voltage variations on power
supply input lines
(IEC 61000-4-11)
Voltage interruptions
(IEC 61000-4-11)
Power frequency (50/60 Hz)
magnetic field
(IEC 61000-4-8)
Radiated RF
(IEC 61000-4-3)
Conducted RF
(IEC 61000-4-6)

11. Electromagnetic compatibility (EMC)

Guidance and manufacturer's declaration – electromagnetic emissions
Guidance and manufacturer's declaration – electromagnetic immunity
IEC 60601 test level
± 8 kV contact
± 15 kV air
± 2 kV for power supply lines
± 1 kV for input/output lines
± 1 kV line(s) to line(s)
± 2 kV line(s) to earth
0% U ; 0.5 cycle
T
At 0°, 45°, 90°, 135°, 180°, 225°, 270° and 315°
0% U
T
AND 70% U
T
Single phase: at 0°
0% U : 250/300 cycles
T
30 A/m
10 V/m
80 MHz to 2.7 GHz
385 MHz at 27 V/m
450 MHz at 28 V/m
710, 745, 780 MHz at 9 V/m
810, 870, 930 MHz at 28 V/m
1720, 1845, 1970 MHz at 28 V/m
2450 MHz at 28 V/m
5240, 5500, 5785 MHz at 9 V/m
3V
0,15 MHz – 80 MHz
6V in ISM bands and amateur radio bands
between 0.15 MHz and 80 MHz
80% MA at 1kHz
; 1 cycle
; 25/30 cycles
23
Compliance
Group 1
Class B
Class A
Complies
Compliance level
± 8 kV
± 15 kV
± 2 kV
± 1 kV
± 1 kV line(s) to line(s)
± 2 kV line(s) to earth
0% U ; 0.5 cycle
T
At 0°, 45°, 90°, 135°, 180°, 225°, 270° and
315°
0% U ; 1 cycle
T
AND 70% U ; 25/30 cycles
T
Single phase: at 0°
0% U : 250/300 cycles
T
30 A/m
10 V/m
80 MHz to 2.7 GHz
385 MHz at 27 V/m
450 MHz at 28 V/m
710, 745, 780 MHz at 9 V/m
810, 870, 930 MHz at 28 V/m
1720, 1845, 1970 MHz at 28 V/m
2450 MHz at 28 V/m
5240, 5500, 5785 MHz at 9 V/m
3V
0,15 MHz – 80 MHz
6V in ISM bands and amateur radio bands
between 0.15 MHz and 80 MHz
80% MA at 1kHz