annex 3 - electromagnetic safety standards

This device conforms to IEC 60601-1-2:2014 Electro Magnetic Compatibility (EMC) standard. Nevertheless, special precautions need to be observed:

PRECAUTION - The use of the B4C wireless sensor adjacent to or stacked with other equipment should be avoided. If such use is necessary, the device and the other equipment should be observed to verify that they are operating normally.

PRECAUTION - Only original charging cables and accessories shipped with the B4C System should be used. Do not use them in any other equipment or device. The use of accessories other than those specified may result in increased emissions or decreased immunity of the device.

PRECAUTION - The B4C System is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or user of the B4C System helps to prevent electromagnetic interference by maintaining a minimum distance of 30cm (12 inches) between portable or mobile RF communication equipment (transmitters) and the B4C System.

Appendix Table 3-1: Compliance Information for Electromagnetic Emissions Requirements Based on IEC 60601-1-2: 2014.

Guidance and manufacturer’s declaration—electromagnetic emissions
The B4C System is intended for use in the electromagnetic environment specified below. The customer or user of the B4C System must ensure that it is used in such an environment.
Emission test	Compliance	Electromagnetic environment—guidance
RF emissions CISPR 11	Group 1	The B4C System uses RF energy only for its internal functions. As such, their RF emissions are very low and unlikely to cause any interference with nearby electronic equipment.
RF emissions CISPR 11	Class B	Although the B4C System is intended to be used in professional healthcare establishments only, RF emissions levels are also compatible with domestic environments, or environments that are connected to the public low-voltage electricity distribution network.
Harmonic Emissions IEC 61000-3-2	N.A.	The B4C wireless sensor is internally powered and cannot be connected to power outlets connected to a power grid.
Voltage Fluctuations/Flicker Emissions IEC 61000-3-3	N.A.

Appendix Table 3-2: Compliance Information for Electromagnetic Immunity Requirements Based on IEC 60601-1-2: 2014.

Guidance and manufacturer’s declaration – electromagnetic immunity
The B4C System is intended for use in the electromagnetic environment specified below. The customer or user of the B4C System must ensure that it is used in such an environment.
Immunity test	IEC 60601-1-2 test level	Compliance level	Electromagnetic 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	Avoid touching the exposed metalic pins of both the external battery and sensor when they are detached.
Electrical fast transient/ burst IEC 61000-4-4	N.A.	N.A.	The B4C wireless sensor is internally powered and cannot be connected to power outlets connected to a power grid. The sensor has no connection to ground, telecom systems or any other equipment. There is no electrical connection to the patient and there is no cable connected to the sensor.
Surge IEC 61000-4-5	N.A.	N.A.
Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11	N.A.	N.A.
Conducted RF IEC 61000-4-6	N.A.	N.A.
Radiated RF electromagnetic fields IEC 61000-4-3	3 V/m 80 MHz to 2.7 GHz 80 % AM at 1 kHz	3 V/m 80 MHz to 2.7 GHz 80 % AM at 1 kHz	Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches)
Proximity fields from RF wireless communications equipment IEC 61000-4-3	See table 3-3	See table 3-3
Power frequency (50/60Hz) magnetic field IEC 61000-4-8	30 A/m (50Hz or 60Hz)	30 A/m (60Hz)	This test level assumes a minimum distance between the ME EQUIPMENT or ME SYSTEM and sources of power frequency magnetic field of at least 15 cm.

Appendix Table 3-3: Test specifications for ENCLOSURE PORT IMMUNITY to RF wireless communications equipment. Table based on Table 9 of IEC60601-1-2:2014

Test specifications for ENCLOSURE PORT 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 to 390	TETRA 400	Pulse modulation 18 Hz	1.8	0.3	27
450	430 to 470	GMRS 460, FRS 460	FM ± 5 kHz deviation 1 kHz sine	2	0.3	28
710	704 to 787	LTE Band 13, 17	Pulse modulation 217 Hz	0.2	0.3	9
745
780
810	800 to 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 to 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 to 2570	Bluetooth, WLAN, 802.11 b/g/n , RFID 2450, LTE Band 7	Pulse modulation 217 Hz	2	0.3	28
5240	5100 to 5800	WLAN 802.11 a/n	Pulse modulation 217 Hz	0.2	0.3	9
5500
5785

Attached Table 3-4: Cabinet Interface Immunity Specifications to Proximity Magnetic Fields. Table based on Table 11 of NBR IEC 60601-1-2:2017/Em1:2022.

Test frequency (MHz)	Modulation	Immunity test level (A/m)
80 kHz	CW	8
134,2 kHz	Pulse modulation 2,1 kHz	65
13,56 MHz	Pulse modulation 50 kHz	7,5

Guidance and manufacturer’s declaration—electromagnetic emissions

Guidance and manufacturer’s declaration – electromagnetic immunity