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This device conforms to IEC 60601-1-2:2014 Electro Magnetic Compatibility (EMC) standard. Nevertheless, special precautions need to be observed:
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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 contact ±2 kV, ±4 kV, | 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.
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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. |
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Test specifications for ENCLOSURE PORT IMMUNITY to RF wireless communications equipment.
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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 |
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Cabinet Interface Immunity Specifications to Proximity Magnetic Fields.
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