Kitett MINIKIT DUO, Instructions For Use Manual

Page: 16 / 78

16
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 functioning.
WARNING: Portable RF communication devices (including peripherals such as aerial cables and external aerials) should
not be within 12 inches (30 cm) of any part of the MINIKIT DUO breast pump, including cables specified by the
manufacturer. Otherwise, performance of these devices 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
EMISSION 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 (IEC 61000-3-3) Compliant
GUIDANCE AND MANUFACTURER’S DECLARATION – ELECTROMAGNETIC IMMUNITY
IMMUNITY TEST TEST LEVEL (IEC 60601) COMPLIANCE LEVEL
Electrostatic discharge (ESD) (IEC
61000-4-2)
± 8kV through direct contact
± 15kV in the air
± 8kV
± 15kV
Fast transients and bursts
(IEC 61000-4-4)
± 2kV for power lines
± 1kV for input/output lines
± 2kV
± 1kV
Transient overvoltage
(IEC 61000-4-5)
± 1kV phase-to-phase
± 2kV phase-to-earth
± 1kV phase-to-phase
± 2kV phase-to-earth
Voltage dips, short outages and
voltage variations on power
supply input lines
(IEC 61000-4-11)
0% UT ; 0,5 cycle
At 0°, 45°, 90°, 135°, 180°, 225°, 270°
and 315°
0% UT ; 0,5 cycle
At 0°, 45°, 90°, 135°, 180°, 225°, 270° and
315°
0% UT ; 1 cycle
and 70% UT ; 25/30 cycles
Single phase : at 0°
0% UT ; 1 cycle
and 70% UT ; 25/30 cycles
Single phase : at 0°
Voltage interruption
(IEC 61000-4-11)
0% UT : 250/300 cycles 0% UT : 250/300 cycles
Magnetic field at power
frequencies (50/60 Hz)
(IEC 61000-4-8)
30A/m 30A/m
RF interference
(IEC 61000-4-3)
10V/m
80 MHz to 2,7 GHz
10V/m
80 MHz to 2,7 GHz
385MHz at 27V/m
450MHz at 28V/m
710, 745, 780MHz at 9V/m
810, 870, 930MHz at 28V/m
1720, 1845, 1970MHz at 28V/m
2450 MHz at 28 V/m
5240, 5500, 5785 MHz at 9 V/m
385MHz at 27V/m
450MHz at 28V/m
710, 745, 780MHz at 9V/m
810, 870, 930MHz at 28V/m
1720, 1845, 1970MHz at 28V/m
2450 MHz at 28 V/m
5240, 5500, 5785 MHz at 9 V/m
Radiated disturbances induced by
RF
(IEC 61000-4-6)
3V
0,15MHz – 80 MHz
6V in ISM bands and amateur radio
bands between 0,15MHz and 80MHz
80% MA at 1kHz
3V
0,15MHz – 80 MHz
6V in ISM bands and amateur radio bands
between 0,15MHz and 80MHz
80% MA at 1kHz