Kitett FISIO PRO, Instructions For Use Manual

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11. Electromagnetic compatibility (EMC)
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.
Guidance and manufacturer's declaration – electromagnetic emissions
Emissions test Compliance
RF emissions (CISPR 11) Group 1
RF emissions (CISPR 11) Class B
Harmonic emissions (IEC 61000-3-2) Class A
Voltage fluctuations / flicker emissions (IEC 61000-3-3) Complies
Guidance and manufacturer's declaration – electromagnetic immunity
Immunity test IEC 60601 test level Compliance level
Electrostatic discharge (ESD)
(IEC 61000-4-2)
± 8 kV contact
± 15 kV air
± 8 kV
± 15 kV
Electrical fast transient / burst
(IEC 61000-4-4)
± 2 kV for power supply lines
± 1 kV for input/output lines
± 2 kV
± 1 kV
Surge
(IEC 61000-4-5)
± 1 kV line(s) to line(s)
± 2 kV line(s) to earth
± 1 kV line(s) to line(s)
± 2 kV line(s) to earth
Voltage dips, short interruptions
and voltage variations on power
supply input lines
(IEC 61000-4-11)
0% U
T
; 0.5 cycle
At 0°, 45°, 90°, 135°, 180°, 225°, 270° and 315°
0% U
T
; 0.5 cycle
At 0°, 45°, 90°, 135°, 180°, 225°, 270° and
315°
0% U
T
; 1 cycle
AND 70% U
T
; 25/30 cycles
Single phase: at 0°
0% U
T
; 1 cycle
AND 70% U
T
; 25/30 cycles
Single phase: at 0°
Voltage interruptions
(IEC 61000-4-11)
0% U
T
: 250/300 cycles 0% U
T
: 250/300 cycles
Power frequency (50/60 Hz)
magnetic field
(IEC 61000-4-8)
30 A/m 30 A/m
Radiated RF
(IEC 61000-4-3)
10 V/m
80 MHz to 2.7 GHz
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
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
Conducted RF
(IEC 61000-4-6)
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
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