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10. Guidance and Manufacturer’s Declaration
OMRON WheezeScan
Information for Accompanying Documents in the Scope of IEC60601-1-2:2014
Important information regarding Electromagnetic Compatibility (EMC)
This device manufactured by OMRON HEALTHCARE Co., Ltd. conforms to IEC60601-1-2:2014 Electromagnetic
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.
• During 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.
• During operation, portable RF communications device (including peripherals such as antenna cables and
external antennas) should be used no closer than 12 inches (30 cm) to any part of the device. 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
Conducted and radiated RF EMISSIONS
CISPR 11
Group1, Class B
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 and patient coupling 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
Conducted disturbances
induced by RF fields
IEC 61000-4-6
6 Vrms
150 kHz to 80 MHz
80 % AM at 1 kHz
for patient coupling port
Rated power frequency
magnetic fields
IEC 61000-4-8
30 A/m
50 Hz or 60 Hz
for enclosure port
