Appendix 2: Emc Compliance - Saadat BP4 User Manual

Appendix 2: EMC compliance

In this section you can find information regarding Electro Magnetic Compatibility (EMC) for Digital blood pressure
monitor.
With the increased number of electronic devices such as PC's and mobile (cellular) telephones, medical devices in use
may be susceptible to electromagnetic interference from other devices. Electromagnetic interference may result in
incorrect operation of the medical device and create a potentially unsafe situation. Medical devices should also not
interfere with other devices. For conformity with the requirements for EMC (Electro Magnetic Compatibility), with the
aim to prevent unsafe situations, the EN60601-1-2 standard has been implemented. This standard defines the levels of
immunity to electromagnetic interference as well as maximum levels of electromagnetic emissions for medical devices.
Our products conform to this EN60601-1-2 standard for both immunity and emissions.
Nevertheless, special precautions need to be observed:
•
The use of accessories and cables other than those specified by manufacturer, may result in increased emission
or decreased immunity of the device.
•
The medical devices should not be used adjacent to or stacked with other equipment. In case adjacent or stacked
use is necessary, the medical device should be observed to verify normal operation in the configuration in which
it will be used.
•
During use (or measurement), portable RF communications device (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. Otherwise,
degradation of the performance of the device could result.
Refer to next pages for EMC Guidance and manufacturer's declaration.
Guidance and manufacturer's declaration –
Digital Blood Pressure Monitor
The BP4 digital blood pressure monitor is intended for use in the electromagnetic environment specified below. The
customer or the user of the patient monitor, should assure that it is used in such an environment.
Emissions Test Compliance
RF emissions
Group 1
CISPR 11
RF emissions
Class B
CISPR 11
Harmonic
emissions N/A
IEC 61000-3-2
Voltage
fluctuations/
flicker N/A
emissions
IEC 61000-3-3
Appendix 2: EMC compliance
Electromagnetic Environment - Guidance
The Digital Blood Pressure Monitor 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.
The Digital Blood Pressure Monitor 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.
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