Cardiac stimulator 4427 Easypace - Instructions for use
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2.1. Electromagnetic compatibility – guidance and manufacturer’s declaration
The 4427 Easypace, like any other medical electrical equipment, needs special
precautions regarding EMC and needs to be used according to the information provided
below.
It’s important to understand that other devices (particularly portable and mobile RF
communications equipment) can affect a medical electrical device. The 4427 device
should not be used adjacent to or stacked with other equipment. In particular the
stimulator must never be used in the presence of high frequency therapeutic and
diagnostic energy sources (e.g.: electrotomes, diathermy devices, RMN etc.) which could
cause malfunctioning, temporary inhibitions of the stimulation, or asynchronous
stimulation.
Electromagnetic emissions
The 4427 device is intended for use in the electromagnetic environment specified below.
The User of the 4427 Easypace should assure that it is used in such an environment.
Emissions test Compliance Electromagnetic environment - guidance
RF emissions CISPR 11 Group 1
Class B
The 4427 device 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.
Harmonic emissions
IEC 61000-3-2
Not applicable
(a)
Voltage fluctuation/flicker
emissions IEC 61000-3-3
Not applicable
(a)
The 4427 device 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.
Electromagnetic immunity
The 4427 device is intended for use in the electromagnetic environment specified below.
The User of the 4427 Easypace 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
Compliant Floors should be wood, concrete or ceramic
tile. If floors are covered with synthetic
material, the relative humidity should be at
least 30%
Electrical fast
transient/burst
IEC 61000-4-2
± 2 kV for power
supply lines
± 1 kV for input/output
lines
Not Applicable
(a)
Mains power quality should be that of a
typical commercial or hospital environment.
Surge
IEC 61000-4-5
± 1 kV differential
mode
± 2 kV common mode
Not Applicable
(a)
Mains power quality should be that of a
typical commercial or hospital environment.
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