Important Information Regarding Electro Magnetic Compatibility (EMC)
This device, manufactured by OMRON HEALTHCARE Co., Ltd., conforms to the EN60601-1-2:2015 Electro Magnetic Compatibility (EMC) standard. Nevertheless, special precautions need to be observed:
- The use of accessories and cables other than those specified or provided by OMRON could result in increased electromagnetic emission or decreased electromagnetic immunity of the device, leading to improper operation.
- During measurement, the use of the device adjacent to or stacked with other devices should be avoided as it could result in improper operation. If such use is necessary, the device and the other device should be observed to verify that they are operating normally.
- During measurement, portable RF communications devices (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the device, including cables specified by OMRON. Otherwise, degradation of the device's performance could result.
- Refer to further guidance below regarding the EMC environment in which the device should be used.
Table 1 - EMISSION Limits and Compliance
| Phenomenon | EMISSION Limits | Compliance |
|---|---|---|
| Conducted and radiated RF EMISSIONS | CISPR 11 | Group1, Class B |
Note: EMISSION tests for Harmonic distortion, Voltage fluctuations, and flicker are not applicable.
IMMUNITY TEST LEVELS
Table 2 - IMMUNITY TEST LEVELS
| Phenomenon | Basic EMC standard | IMMUNITY TEST LEVELS |
|---|---|---|
| Electrostatic discharge | IEC 61000-4-2 | ±8 kV contact ±2 kV, ±4 kV, ±8 kV, ±15 kV air |
| Radiated RF electromagnetic fields | IEC 61000-4-3 | 10 V/m 80 MHz to 2.7 GHz 80 % AM at 1 kHz |
| Proximity fields from RF wireless communications equipment | IEC 61000-4-3 | See table 3 |
| Rated power frequency magnetic fields | IEC 61000-4-8 | 30 A/m 50 Hz and 60 Hz |
Note: IMMUNITY tests for Input A.C. power port, Input D.C. power port, Patient coupling port, and Signal input/output parts port are not applicable. For patient coupling port, electrostatic discharge is applicable.
Test Specifications for ENCLOSURE PORT IMMUNITY to RF Wireless Communications Device
Table 3 - Test specifications for ENCLOSURE PORT IMMUNITY to RF wireless communications device
| 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 |
| 710 745 | 704 to 787 | LTE Band 13, 17 | Pulse modulation 217 Hz | 0.2 | 0.3 | 9 |
| 780 | ||||||
| 810 870 930 | 800 to 960 | GSM 800/900, TETRA 800, iDEN 820, CDMA 850, LTE Band 5 | Pulse modulation 18 Hz | 2 | 0.3 | 28 |
| 1720 | ||||||
| 1845 1970 | 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 |
| 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 5500 5785 | 5100 to 5800 | WLAN 802.11 a/n | Pulse modulation 217 Hz | 0.2 | 0.3 | 9 |
