ProMed PBM-4.2 Instruction Leaflet page 138

EMC DECLARATION
IEC 60601-1-2:2014 ME EQUIPMENT and ME SYSTEMS identification, marking and
documents for Class B product
Instructions for use
The ME EQUIPMENT or ME SYSTEM is suitable for home environment
Warning: Don't near active HF surgical equipment and the RF shielded room of an ME system for
magnetic resonance imaging, where the intensity of EM disturbances is high.
Warning: Use of this equipment adjacent to or stacked with other equipment should be avoided because
it could result in improper operation. If such use is necessary, this equipment and the other equipment
should be observed to verify that they are operating normally.
Warning: Use of accessories, transducers and cables other than those specified or provided by the
manufacturer of this equipment could result in increased electromagnetic emissions or decreased
electromagnetic immunity of this equipment and result in improper operation."
Warning: 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 equipment (detail
model name), including cables specified by the manufacturer. Otherwise, degradation of the performance
of this equipment could result.
If any: a list of all cables and maximum lengths of cables (if applicable), transducers and other
ACCESSORIES that are replaceable by the RESPONSIBLE ORGANIZATION and that are likely to affect
compliance of the ME EQUIPMENT or ME SYSTEM with the requirements of Clause 7 (EMISSIONS)
and Clause 8 (IMMUNITY). ACCESSORIES may be specified either generically (e.g. shielded cable,
DE
load impedance) or specifically (e.g. by MANUFACTURER and EQUIPMENT OR TYPE REFERENCE).
If any: the performance of the ME EQUIPMENT or ME SYSTEM that was determined to be ESSENTIAL
PERFORMANCE
PERFORMANCE is lost or degraded due to EM DISTURBANCES (the defined term "ESSENTIAL
EN
PERFORMANCE" need not be used).
Technical description
FR
1.all necessary instructions for maintaining BASIC SAFETY and ESSENTIAL PERFORMANCE with regard
to electromagnetic disturbances for the excepted service life.
2. Guidance and manufacturer's declaration -electromagnetic emissions and Immunity.
IT Table 1
Guidance and manufacturer's declaration - electromagnetic emissions
Emissions test
ES
RF emissions CISPR 11
RF emissions CISPR 11
Harmonic emissions
NL
IEC 61000-3-2
Voltage fluctuations/ flicker emissions IEC 61000-3-3
Table 2
RU
Guidance and manufacturer's declaration - electromagnetic Immunity
Immunity Test
PL
Electrostatic discharge (ESD)
IEC 61000-4-2
SE
Electrical fast transient/burst
IEC 61000-4-4
Surge
IEC 61000-4-5
AR
and a description of what the OPERATOR can expect if the ESSENTIAL
IEC 60601-1-2
Test level
±8 kV contact
±2 kV, ±4 kV, ±8 kV, ±15 kV air
Power supply lines: ±2 kV
input/output lines: ±1 kV
line(s) to line(s): ±1 kV.
line(s) to earth: ±2 kV.
100 kHz repetition frequency
Compliance
Group 1
Class B
Not application
Not application
Compliance level
±8 kV contact
±2 kV, ±4 kV, ±8 kV,
±15 kV air
Not application
Not application
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