6.5 EMC notice

General information

This device is for use in professional healthcare facility environments only.

With the installation of the device, use only the delivered external cables and power supply or a spare part provided by the legal manufacturer. Using another can result in a decrease of the immunity level of the device.

Warning: Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally.
Warning: Use of accessories, transducers and cables other than those specified or provided by the manufacturer of this equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation.
Warning: Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the Nio Color 5MP, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result.
Electromagnetic emissions

The Nio Color 5MP is intended for use in the electromagnetic environment specified below. The customer or the user of the Nio Color 5MP should assure that it is used in such an environment.

Emissions testComplianceElectromagnetic environment – Guidance

RF emissions

CISPR 11

Group 1The Nio Color 5MP uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.

RF emissions

CISPR 11

Class BThe Nio Color 5MP is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.

Harmonic emissions

IEC 61000-3-2

Class D

Voltage fluctuations/ flicker emissions

IEC 61000-3-3

Complies

This Nio Color 5MP complies with appropriate medical EMC standards on emissions to, and interference from surrounding equipment. Operation is subject to the following two conditions: (1) this device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation.

Interference can be determined by turning the equipment off and on.

If this equipment does cause harmful interference to, or suffer from harmful interference of, surrounding equipment, the user is encouraged to try to correct the interference by one or more of the following measures:

Electromagnetic immunity

The Nio Color 5MP is intended for use in the electromagnetic environment specified below. The customer or the user of the Nio Color 5MP should assure that it is used in such an environment.

Immunity testIEC 60601-1-2 test levelsCompliance levelElectromagnetic environment – guidance

Electrostatic discharge (ESD)

IEC 61000-4-2

± 8 kV contact

± 2 kV, ± 4 kV, ± 8 kV, ± 15 kV air

± 8 kV contact

± 2 kV, ± 4 kV, ± 8 kV, ± 15 kV air

Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%

Electrical fast transient/burst

IEC 61000-4-4

± 2 kV for power supply lines

± 1 kV for input/ output lines

100 kHz repetition frequency

± 2 kV for power supply lines

± 1 kV for input/ output lines

100 kHz repetition frequency

Mains power quality should be that of a typical commercial or hospital environment

Surge

IEC61000-4-5

Line to line: ± 0.5 kV, ± 1 kV

Line to ground: ± 0.5 kV, ± 1 kV, ± 2 kV

Line to line: ± 0.5 kV, ± 1 kV

Line to ground: ± 0.5 kV, ± 1 kV, ± 2 kV

Mains power quality should be that of a typical commercial or hospital environment

Voltage dips, short interruptions and voltage variations on power supply input lines

IEC 61000-4-11

0% residual voltage for 0.5 period at 0°, 45°, 90°, 135°, 180°, 225°, 270° and 315°

0% residual voltage for 1 period at 0°

70% residual voltage for 25 periods at 0°

Voltage interruptions: 0% residual voltage for 250 periods at 0°

0% residual voltage for 0.5 period at 0°, 45°, 90°, 135°, 180°, 225°, 270° and 315°

0% residual voltage for 1 period at 0°

70% residual voltage for 25 periods at 0°

Voltage interruptions: 0% residual voltage for 250 periods at 0°

Mains power quality should be that of a typical commercial or hospital environment. If the user of the Nio Color 5MP requires continued operation during power mains interruptions, it is recommended that the Nio Color 5MP be powered from an uninterruptible power supply or a battery

Power frequency (50/60 Hz) magnetic field

IEC 61000-4-8

30 A/mNot applicable [4]Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment

Conducted RF

IEC 61000-4-6

3 Vrms (6 Vrms in ISM bands)

150 kHz to 80 MHz

3 Vrms (6 Vrms in ISM bands)

-

Radiated RF

IEC 61000-4-3

3 V/m

80 MHz to 2.7 GHz

3 V/m
Immunity to RF wireless communications equipment
Test frequency (MHz)Band (MHz)ServiceModulationMaximum power (W)Distance (m)Immunity test level (V/m)
385380 – 390TETRA 400Pulse modulation 18 Hz1.80.327
450430 – 470GMRS 460, FRS 460

FM ± 5 kHz deviation

1 kHz sine

20.328
710704 – 787LTE Band 13, 17Pulse modulation 217 Hz0.20.39
745
780
810800 – 960GSM 800/900, TETRA 800, iDEN 820, CDMA 850, LTE Band 5Pulse modulation 18 Hz20.328
870
930
17201700 – 1990GSM 1800, CDMA 1900, GSM 1900, DECT, LTE Band 1/3/4/25, UMTSPulse modulation 217 Hz20.328
1845
1970
24502400 – 2570Bluetooth, WLAN, 802.11 b/g/n, RFID 2450, LTE Band 7Pulse modulation 217 Hz20.328
52405100 – 5800W LAN 802.11 a/nPulse modulation 217 Hz0.20.39
5500
5785

[4] Nio Color 5MP doesn’t contain components that are susceptible to magnetic fields.