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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 PURENEB device, 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
