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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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. |
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PRECAUTION - Only original charging cables and accessories shipped with the B4C System should be used. Do |
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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. |
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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. |
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PRECAUTION - The B4C System may be affected by equipment that emits RF signals in the environment in which it is |
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installed. Using the device close to RFID readers can cause temporary loss of wireless functionalities. |
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. |
RF emissions CISPR 11 | Class B | Although the B4C System is determined intended to be used in professional healthcare establishments only, RF emissions levels are also compatible with domestic enviromentsenvironments, or enviroments 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 the mainsa 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 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 the mainsa 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. |
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
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