Emc Declaration - Plusmed pM-KN01 Mode D'emploi

EMC Declaration

The pM-KN01 needs special precautions regarding EMC and needs to be installed and put into service according to
the EMC information provided in the accompanying documents;
Portable and mobile RF communications equipment can affect the pM-KN01.
All cables and maximum length of cables, Transducers and other accessories with which the manufacturer of the
pM-KN01 claims compliance with the requirements, Accessories that do not affect compliance with the requirements
of these sub clauses need not be listed. Accessories, transducers and cables may be specified either generically or
specifically.
NOTE
Transducers and cables sold by the manufacturer of the pM-KN01 as replacement parts for internal components need
not be listed.
The use of accessories, transducers and cables other than those specified, with the exception of transducers and cab-
les sold by the manufacturer of The pM-KN01 as replacement parts for internal components, may result in increased
emissions or decreased immunity of The pM-KN01.
The pM-KN01 is intended for use in the electromagnetic environment specified below. The customer or the user of the pM-KN01 should
assure that it is used in such an environment.
Emissions test
RF emissions
CISPR 11
RF emissions
CISPR 11
Harmonic emissions
IEC 61000-3-2
Voltage fluctuations/
flicker emissions
IEC 61000-3-3
The pM-KN01 is intended for use in the electromagnetic environment specified below. The customer or the user of the pM-KN01 should
assure that it is used in such an environment.
IMMUNITY test
Electrostatic ± 6 kV contact
discharge (ESD) ± 8 kV air
IEC 61000-4-2
Electrical fast ± 2 kV for power
transient/burst supply lines
IEC 61000-4-4 ± 1 kV for input/
output
Lines
Surge ± 1 kV line(s) to
IEC 61000-4-5 line(s)
± 2 kV line(s) to earth
28
Guidance and manufacturer's declaration – electromagnetic emissions
Compliance
Group 1 The pM-KN01 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.
Class A The pM-KN01 is suitable for use in all establishments other than domestic, and may
be used in domestic establishments and those directly connected to the public low-
voltage power supply network that supplies buildings used for domestic purposes,
Class A
provided the following warning is heeded:
Warning: This pM-KN01 is intended for use by healthcare professionals only. This
equipment/ system may cause radio interference or may disrupt the operation of nearby
Complies
equipment. It may be necessary to take mitigation measures, such as re-orienting or
relocating the pM-KN01 or shielding the location.
Guidance and manufacturer's declaration – electromagnetic immunity
IEC 60601 Compliance level
test level
± 6 kV contact
± 8 kV air
± 2 kV for power
supply lines
± 1 kV for input/output
lines
± 1 kV line(s) to
line(s)
± 2 kV line(s) to earth
Electromagnetic environment – guidance
Electromagnetic environment –
Floors should be wood, concrete or ceramic tile. If floors
are covered with synthetic material, the relative humidity
should be at least 30 %.
Mains power quality should be that of a typical commercial
or hospital environment.
Mains power quality should be that of a typical commercial
or hospital environment.
guidance