Coronis Fusion 4MP / 6MP - EMC notice

7.5 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 Coronis Fusion 4MP / 6MP, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result.

Electromagnetic emissions

Emissions test	Compliance
RF emissions (CISPR 11)	Group 1
RF emissions (CISPR 11)	Class B
Harmonic emissions (IEC 61000-3-2)	Class D
Voltage fluctuations/ flicker emissions (IEC 61000-3-3)	Complies

This Coronis Fusion 4MP / 6MP 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:

Reorient or relocate the receiving antenna or equipment.
Increase the separation between the equipment and receiver.
Connect the equipment into an outlet on a circuit different from that to which the receiver is connected.
Consult the dealer or an experienced technician for help.

Electromagnetic immunity

Test	60601-1-2 Test level	Compliance level according TR 60601-4-2
Electrostatic discharge Immunity (IEC 61000-4-2)	± 8 kV contact ± 2 kV, ± 4 kV, ± 8 kV, ± 15 kV air	± 4 kV contact ± 2 kV, ± 4 kV, ± 8 kV air
Electrical fast transient/burst Immunity (IEC 61000-4-4)	± 2 kV/100kHz (power) ± 1 kV/100kHz (signal) All cables >3m	±2kV (5kHz or 100kHz power) ±0.5kV (5kHz or 100kHz signal) All cables >3m
Surge Immunity (IEC61000-4-5)	±0,5kV, ±1kV line-to-line ±0,5kV, ±1kV, 2kV line-to-ground	±0,5kV, ±1kV line-to-line ±0,5kV, ±1kV, 2kV line-to-ground
Voltage dips, short interruptions and voltage Variations Immunity (IEC 61000-4-11)	0% UT 0,5 cycle at 0°, 45°, 90°, 135°, 180°, 225°, 270° and 315° 0% UT 1 cycle 70% UT 25/30 cycles at 0° 0% UT 250/300 cycles	0% UT 0,5 cycle at 0°, 180° 70% UT 25/30 cycles at 0° 0% UT 250/300
Power frequency magnetic field Immunity (IEC 61000-4-8)	30 A/m 50Hz or 60Hz	3 A/m 50Hz or 60Hz
Immunity to conducted disturbances induced by RF fields (IEC 61000-4-6)	3V/ 150kHz-80MHz 6V in ISM bands 80% AM 1kHz All cables >1m	3V/ 150kHz-80MHz (ISM bands N.A.) 80% AM 1kHz All cables >3m
Radiated RF electromagnetic field Immunity (IEC 61000-4-3)	3V/m 80MHz-2,7GHz 80% AM 1kHz	3V/m 80MHz-2,7GHz 80% AM 1kHz
Immunity to proximity fields from RF wireless communications equipment (IEC 61000-4-3)	385 MHz 18Hz PM 27V/m 450 MHz 1kHz FM 28V/m 710 MHz 217Hz PM 9V/m 745 MHz 217Hz PM 9V/m 780 MHz 217Hz PM 9V/m 810 MHz 18Hz PM 28V/m 870 MHz 18Hz PM 28V/m 930 MHz 18Hz PM 28V/m 1720 MHz 217Hz PM 28V/m 1845 MHz 217Hz PM 28V/m 1970 MHz 217Hz PM 28V/m 2450 MHz 217Hz PM 28V/m 5240 MHz 217Hz PM 9V/m 5500 MHz 217Hz PM 9V/m 5785 MHz 217Hz PM 9V/m	385 MHz 18Hz PM 6V/m 450 MHz 1kHz FM 9V/m 710 MHz 217Hz PM 3V/m 745 MHz 217Hz PM 3V/m 780 MHz 217Hz PM 3V/m 810 MHz 18Hz PM 9V/m 870 MHz 18Hz PM 9V/m 930 MHz 18Hz PM 9V/m 1720 MHz 217Hz PM 9V/m 1845 MHz 217Hz PM 9V/m 1970 MHz 217Hz PM 9V/m 2450 MHz 217Hz PM 9V/m 5240 MHz 217Hz PM 6V/m 5500 MHz 217Hz PM 6V/m 5785 MHz 217Hz PM 6V/m

Test

60601-1-2 Test level

Compliance level according TR 60601-4-2

Electrostatic discharge Immunity (IEC 61000-4-2)

± 8 kV contact

± 2 kV, ± 4 kV, ± 8 kV, ± 15 kV air

± 4 kV contact

± 2 kV, ± 4 kV, ± 8 kV air

Electrical fast transient/burst Immunity (IEC 61000-4-4)

± 2 kV/100kHz (power)

± 1 kV/100kHz (signal)

All cables >3m

±2kV (5kHz or 100kHz power)

±0.5kV (5kHz or 100kHz signal)

All cables >3m

Surge Immunity (IEC61000-4-5)

±0,5kV, ±1kV line-to-line

±0,5kV, ±1kV, 2kV line-to-ground

±0,5kV, ±1kV line-to-line

±0,5kV, ±1kV, 2kV line-to-ground

Voltage dips, short interruptions and voltage Variations Immunity (IEC 61000-4-11)

0% UT 0,5 cycle at 0°, 45°, 90°, 135°, 180°, 225°, 270° and 315°

0% UT 1 cycle

70% UT 25/30 cycles at 0°

0% UT 250/300 cycles

0% UT 0,5 cycle at 0°, 180°

70% UT 25/30 cycles at 0°

0% UT 250/300

Power frequency magnetic field Immunity

(IEC 61000-4-8)

30 A/m

50Hz or 60Hz

3 A/m

50Hz or 60Hz

Immunity to conducted disturbances induced by RF fields (IEC 61000-4-6)

3V/ 150kHz-80MHz

6V in ISM bands

80% AM 1kHz

All cables >1m

3V/ 150kHz-80MHz

(ISM bands N.A.)

80% AM 1kHz

All cables >3m

Radiated RF electromagnetic field Immunity

(IEC 61000-4-3)

3V/m

80MHz-2,7GHz

80% AM 1kHz

3V/m

80MHz-2,7GHz

80% AM 1kHz

Immunity to proximity fields from RF wireless communications equipment (IEC 61000-4-3)

385 MHz 18Hz PM 27V/m

450 MHz 1kHz FM 28V/m

710 MHz 217Hz PM 9V/m

745 MHz 217Hz PM 9V/m

780 MHz 217Hz PM 9V/m

810 MHz 18Hz PM 28V/m

870 MHz 18Hz PM 28V/m

930 MHz 18Hz PM 28V/m

1720 MHz 217Hz PM 28V/m

1845 MHz 217Hz PM 28V/m

1970 MHz 217Hz PM 28V/m

2450 MHz 217Hz PM 28V/m

5240 MHz 217Hz PM 9V/m

5500 MHz 217Hz PM 9V/m

5785 MHz 217Hz PM 9V/m

385 MHz 18Hz PM 6V/m

450 MHz 1kHz FM 9V/m

710 MHz 217Hz PM 3V/m

745 MHz 217Hz PM 3V/m

780 MHz 217Hz PM 3V/m

810 MHz 18Hz PM 9V/m

870 MHz 18Hz PM 9V/m

930 MHz 18Hz PM 9V/m

1720 MHz 217Hz PM 9V/m

1845 MHz 217Hz PM 9V/m

1970 MHz 217Hz PM 9V/m

2450 MHz 217Hz PM 9V/m

5240 MHz 217Hz PM 6V/m

5500 MHz 217Hz PM 6V/m

5785 MHz 217Hz PM 6V/m

Immunity to RF wireless communications equipment

Test frequency (MHz)	Band (MHz)	Service	Modulation	Maximum power (W)	Distance (m)	Immunity test level (V/m)
385	380 – 390	TETRA 400	Pulse modulation 18 Hz	1.8	0.3	27
450	430 – 470	GMRS 460, FRS 460	FM ± 5 kHz deviation 1 kHz sine	2	0.3	28
710	704 – 787	LTE Band 13, 17	Pulse modulation 217 Hz	0.2	0.3	9
745
780
810	800 – 960	GSM 800/900, TETRA 800, iDEN 820, CDMA 850, LTE Band 5	Pulse modulation 18 Hz	2	0.3	28
870
930
1720	1700 – 1990	GSM 1800, CDMA 1900, GSM 1900, DECT, LTE Band 1/3/4/25, UMTS	Pulse modulation 217 Hz	2	0.3	28
1845
1970
2450	2400 – 2570	Bluetooth, WLAN, 802.11 b/g/n, RFID 2450, LTE Band 7	Pulse modulation 217 Hz	2	0.3	28
5240	5100 – 5800	W LAN 802.11 a/n	Pulse modulation 217 Hz	0.2	0.3	9
5500
5785