Grundig BP101U - Compliance Level

overvoltage: Il;
pollution degree:2
• The risk of patient and user can be lowered to acceptable level.
• The unit might not meet its performance specification if stored or
• Used outside the following specified temperature, humidity and Altitude ranges.
• The unit satisfies the requirements of IEC60601-1 Medical electrical equipment,
IEC 60601-1-2: Electromagnetic compatibility –Requirements and tests
IEC 80601-2-30: Non-invasive sphygmomanometers - Part 1: Requirements and test methods for
non-automated measurement
Type EN 1060-3: Non-invasive sphygmomanometers - Part 3: Supplementary requirements for
electro-mechanical blood pressure measuring systems
EMC Table
• Guidance and manufacture’s declaration
GUIDANCE AND MANUFACTURE’S DECLARATION – ELECTROMAGNETIC EMISSION
The Digital Blood Pressure Monitor is intended for use in the electromagnetic environment specified below. The
customer of the user of the Digital Blood Pressure Monitor should assure that it is used in such an
environment.
Emission test
Compliance
Electromagnetic environment – guidance
RF emissions CISPR 11 Group 1
The Digital Blood Pressure Monitor use 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.
RF emission CISPR 11
Class B
The Digital Blood Pressure Monitor 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 Emissions IEC 61000-3-2
Not
applicable
Voltage fluctuations/ flicker emissions
IEC 61000-3-3
Not
applicable
GUIDANCE AND MANUFACTURE’S DECLARATION – ELECTROMAGNETIC IMMUNITY
The Digital Blood Pressure Monitor is intended for use in the electromagnetic environment specified below. The
customer or the user of Digital Blood Pressure Monitor should assure that it is used in such an environment.
Immunity test
IEC 60601 test
level
Compliance
level
Electromagnetic environment - guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2
±6 kV contact
±8 kV air
±6 kV contact
±8 kV air
Floors should be wood, concrete or ceramic tile. If floor
is covered with synthetic material, the relative humidity
should be at least 30%.
Power frequency
(50Hz/60Hz)
magnetic field IEC
61000-4-8
3A/m 3A/m
Power frequency magnetic fields should be at levels
characteristic of a typical location in a typical
commercial or hospital environment.
Note: UT is the a.c. mains voltage prior to application of the test level
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