Omron NEU-200 - Information for accompanying documents in the scope of IEC 60601-1-2:2014
By Omron Healthcare India Pvt. Ltd., 16 Apr 2021
OMRON mains-operated Nebulizer NE-U200
Applicable models: Refer to” EMC product reference table Nebulizer” Information for accompanying documents in the scope of IEC 60601-1-2:2014
Important information regarding Electro Magnetic Compatibility (EMC):
This device manufactured by OMRON HEALTHCARE Co., Ltd. conforms to IEC 60601-1-2:2014 Electro Magnetic Compatibility (EMC) standard. Nevertheless, special precautions need to be observed:
The use of accessories other than those specified or provided by OMRON could result in increased electromagnetic emission or decreased electromagnetic immunity of the device and result in improper operation.
The use of the device adjacent to or stacked with other device should be avoided because it could result in improper operation. In case such use is necessary, the device and other device should be observed to verify that they are operating normally.
Portable RF communications device (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm to any part of the device, specified by OMRON. Otherwise, degradation of the performance of the device 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 |
|
Radiated RF EMISSIONS |
CISPR 11 |
Group1, Class B |
|
Voltage fluctuations and flicker |
See IEC 61000-3-3 |
N/A |
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 for enclosure port |
|
Radiated RF electromagnetic fields |
IEC 61000‐4‐3 |
10 V/m 80 MHz to 2.7 GHz 80 % AM at 1 kHz for enclosure port |
|
Proximity fields from RF wireless communications equipment |
IEC 61000‐4‐3 |
See table 3 |
|
Electrical fast transients / bursts |
IEC 61000‐4‐4 |
N/A |
|
Surges Line‐to‐line |
IEC 61000‐4‐5 |
N/A |
|
Conducted disturbances induced by RF fields |
IEC 61000‐4‐6 |
N/A |
|
Rated power frequency magnetic fields |
IEC 61000‐4‐8 |
30 A/m 50 Hz or 60 Hz for enclosure port |
|
Voltage dips |
IEC 61000‐4‐11 |
|
|
N/A |
||
|
Voltage interruptions |
IEC 61000‐4‐11 |
N/A |
|
Note: UT is the A.C. mains voltage prior to application of the test level. |
||
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 土 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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