Saadat Dena User Manual page 58

Electrocardiograph
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Guidance and manufacturer's declaration – Dena 1210 emissions
The Dena 1210 is intended for use in the electromagnetic environment specified below. The
customer or the user of the Dena 1210, 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
Guidance and manufacturer's declaration – electromagnetic immunity
The Dena 1210 is intended for use in the electromagnetic environment specified below. The
customer or the user of the Dena 1210 should assure that it is used in such an environment.
Immunity test
Electrostatic discharge
(ESD) IEC 61000-4-2
Electrical fast
transient/burst IEC
61000-4-4
Surge
Compliance
Group 1
Class B
Complies
Complies
Port
Enclosure
Patient coupling
Signal input/output parts
Input a.c. power
Signal input/output parts
Input a.c. power
53
Electromagnetic environment -
guidance
The Dena 1210 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 Dena 1210 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.
Compliance level
Floors should be
wood, concrete or
ceramic tile. If floors
are covered with
±8 kV contact
synthetic material, the
relative humidity
± 2 kV, ± 4 kV, ±
should be at least
8 kV, ±15 kV air
30%.
± 2 kV, 100 kHz
Mains power quality
repetition
should be that of a
frequency
typical commercial or
± 1 kV
hospital environment.
100 kHz
repetition
frequency
± 0,5 kV, ± 1 kV
Line-to-line
Mains power quality
should be that of a
± 0,5 kV, ± 1 kV,
typical commercial or
± 2 kV Line-to-
hospital environment.
ground
Electromagnetic
environment -
guidance

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