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DM-4000 complies with the EMC, electromagnetic compatibility, standard, IEC60601-1-2. Refer to the tables below for specific information
regarding compliance to the standard.
DM-4000, as a medical electrical equipment, needs special precautions regarding EMC and needs to be installed and put into service according to
the EMC information provided below.
Portable and mobile RF communications equipments can affect the device.
The use of accessories other than those specified in this manual may result in increased emissions or decreased immunity of the device.
DM-4000 should not be used adjacent to or stacked with other equipment.
DM-4000 is intended for use in the electromagnetic environment specified below. The customer or the user of DM-4000 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
Compliance
Group 1
Class A
N/A
Complies
Electromagnetic environment - guidance
DM-4000 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.
DM-4000 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.
Table 1 - Guidance and manufacturer’s declaration - electromagnetic emissions -
DM-4000 is intended for use in the electromagnetic environment specified below. The customer or the user of DM-4000 should assure that it is
used in such an environment.
NOTE U
T
is the a.c. mains voltage prior to application of the test level.
Immunity test
Electrostatic
discharge (ESD) IEC
61000-4-2
Electrical fast
transient/burst IEC
61000-4-4
Surge IEC 61000-4-5
Voltage dips, short
interruptions and
voltage variations on
power supply input
lines IEC 61000-4-11
Power frequency
(50/60 Hz) magnetic
field IEC 61000-4-8
IEC 60601 test level
±6 kV contact
±8 kV air
±2 kV for power supply lines
±1 kV for input/ output lines
±1 kV differential mode
±2 kV common mode
<5% U
T
(>95% dip in U
T
) for 0,5 cycle
40% U
T
(60% dip in U
T
) for 5 cycles
70% U
T
(30% dip in U
T
) for 25 cycles
<5% U
T
(>95% dip in U
T
) for 5 sec
3 A/m
Compliance level
±6 kV contact
±8 kV air
±2 kV for power supply lines
±1 kV for input/ output lines
±1 kV differential mode
±2 kV common mode
<5% U
T
(>95% dip in U
T
) for 0,5 cycle
40% U
T
(60% dip in U
T
) for 5 cycles
70% U
T
(30% dip in U
T
) for 25 cycles
<5% U
T
(>95% dip in U
T
) for 5 sec
3 A/m
Electromagnetic environment - guidance
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.
Mains power quality should be that of a
typical commercial or hospital
environment. If the user of DM-4000
requires continued operation during power
mains interruptions, it is recommended
that DM-4000 is be powered from an
uninterruptible power supply or a battery.
Power frequency magnetic fields should
be at levels characteristic of a typical
location in a typical commercial or hospital
environment.
Table 2 - Guidance and manufacturer’s declaration - electromagnetic immunity -
Care and maintenance
Because the device includes precision parts, care should be taken to avoid extreme temperature
variations, humidity, shock, dust, and direct sunlight. Do not drop or strike the device. Make
sure not to expose the unit to moisture. This unit is not water resistant.
Use only a soft, dry cloth to clean the device. Do not use gasoline, paint thinner, chemicals
such as strong soda, strong acids, oxidizing agents and reducing agents, or other strong
solvents on the unit. Since the cuffs may absorb perspiration and other fluids, inspect them for
stains and discoloration after each use. Cotton cuff shells are hand/machine-washable. Take out
bladders from inside the cuffs before washing cotton shells. Use common detergents. Air dry
thoroughly.
When storing the device, do not place heavy objects on it and do not coil AIR TUBE too tightly.
When the unit has been stored at a temperature below the freezing point, keep it for at least 1
hour in a warm place before using. Keep the batteries out of reach of children.
Do not inflate the cuff when it is not wrapped around an arm.
Do not disassemble or modify the device.
We suggest that the device be checked every 2 years. This operation may only be performed by
the manufacturer or by authorized agents of the manufacturer.
