BeneVision N1 Patient Monitor Operator’s Manual
B - 1
B
EMC and Radio Regulatory Compliance
B.1
EMC
The device meets the requirements of IEC 60601-1-2: 2014.
WARNING
•
Use of accessories, transducers and cables other than those specified or provided by the
manufacturer of this device could result in increased electromagnetic emissions or decreased
electromagnetic immunity of this device and result in improper operation.
•
Use of this device adjacent to or stacked with other device should be avoided because it could result
in improper operation. If such use is necessary, this device and the other device should be observed
to verify that they are operating normally.
•
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 device
could result.
•
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.
•
This device is intended for use in professional healthcare facility environment and home healthcare
environment only. 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.
NOTE
•
The device needs special precautions regarding EMC and needs to be installed and put into service
according to the EMC information provided below.
•
Other devices may affect this device even though they meet the requirements of CISPR.
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 device.
Conducted and radiated RF
EMISSIONS
CISPR 11
Class B
The device is suitable for use in all establishments, including
domestic establishments and those directly connected to the
public low-voltage power supply network that supplies
buildings used for domestic purposes.
Conducted and radiated RF
EMISSIONS
CISPR 11
Class A
(Used with Dock)
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
IEC 61000-3-2
Class A
The device is suitable for use in all establishments, including
domestic establishments and those directly connected to the
public low-voltage power supply network that supplies
buildings used for domestic purposes.
Voltage fluctuations and
flicker
IEC 61000-3-3
Complies
