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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.

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