File No.: QR-HC21-C-C09
Xiamen Linktop Technology Co., Ltd.
Page 13 of 17
11. ELECTROMAGNETIC COMPATIBILITY
The Electronic Stethoscope has been tested and found to comply with the electromagnetic
compatibility (EMC) limits for medical devices. These limits are designed to provide
reasonable protection against harmful interference in a typical medical installation.
a) Do not use a mobile phone or other devices that emit electromagnetic fields, near the unit.
This may result in abnormal operation of the unit.
b) Caution: This unit has been thoroughly tested and inspected to assure proper performance
and operation!
c) Caution: this machine should not be used adjacent to or stacked with other equipment and
that if adjacent or stacked use is necessary, this machine should be observed to verify normal
operation in the configuration in which it will be used.
Manufacturer’s declaration – electromagnetic emissions
The Electronic Stethoscope is intended for use in the electromagnetic environments specified
below. The customer or the user of the Electronic Stethoscope should assure that it is used in
such an environment.
Emissions test
Compliance
Electromagnetic environment - guidance
RF emissions
CISPR 11
Group 1
The Electronic Stethoscope 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 emissions
CISPR 11
Class B
The Electronic Stethoscope 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.
Harmonic emissions
IEC 61000-3-2
Not applicable
Voltage function /
flicker emissions
IEC 61000-3-3
Not applicable
Manufacturer’s declaration – electromagnetic immunity
The Electronic Stethoscope is intended for use in the electromagnetic environment specified
below. The customer or the user of the Electronic Stethoscope 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
±8kV contact
±2, 4, 8, 15kV air
±8kV contact
±2, 4, 8, 15kV air
Floors should be
wood, concrete or
ceramic tile. If floors
