B - 1
B EMC and Radio Regulatory Compliance
B.1 EMC
The device meets the requirements of IEC 60601-1-2: 2014.
• Use of accessories, transducers and cables other than those specified or provided by the
manufacturer of this equipment could result in increased electromagnetic emissions or decreased
electromagnetic immunity of this equipment and result in improper operation.
• The non-ME EQUIPMENT (e.g. ITE) that is a part of an ME SYSTEM may be disrupted by the
electromagnetic interference of nearby equipment. It may be necessary to take mitigation
measures, such as re-orienting or relocating the non-ME EQUIPMENT or shielding the location.
• Use of this equipment adjacent to or stacked with other equipment should be avoided because it
could result in improper operation. If such use is necessary, this equipment and the other equipment
should be observed to verify that they are operating normally.
• This device is intended for use in professional healthcare facility environment and home healthcare
environment. If it is used in special environment, such as magnetic resonance imaging environment,
the equipment/system may be disrupted by the operation of nearby equipment.
• Portable RF communications equipment (including peripherals such as antenna cables and external
antennas) should be used no closer than 30 cm (12 inches) to any part of the this device, including
cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment
could result.
If the system is operated within the electromagnetic environment listed in Table Guidance and Declaration -
Electromagnetic Immunity, the system will remain safe and provide the following essential performance:
■ Operating mode
■ Accuracy
■ Function
■ Accessories identification
■ Data stored
■ Alarm
■ Detect for connection
Guidance and Declaration - Electromagnetic Emissions
The device is intended for use in the electromagnetic environment specified below. The customer or the user of the device
should assure that it is used in such an environment.
Emission tests Compliance Electromagnetic environment - guidance
Conducted and radiated RF
EMISSIONS CISPR 11
Group 1 The device uses RF energy only for its internal function.
Therefore, its RF emissions are very low and are not likely to
cause any interference in nearby electronic equipment.
Conducted and radiated RF
EMISSIONS CISPR 11
Class A The device is suitable for use in all establishments other than
domestic and those directly connected to the public low-voltage
power supply network that supplies buildings used for domestic
purposes
Harmonic distortion
EMISSIONS IEC61000-3-2
Class A
Voltage Fluctuations/Flicker
EMISSIONS IEC 61000-3-3
Complies
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