6
Table I Manufacturer’s Declaration Regarding Electromagnetic Emissions
NOTE: Portable and mobile RF communication equipment can affect medical electrical equipment.
Table II Manufacturer’s Declaration Regarding Electromagnetic Immunity
Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic Environment Guidance
Electrostatic Discharge
(ESD) IEC 61000-4-2
±6kV Contact
±8kV air
±6kV Contact
±8kV air
Floors should be wood, concrete or ceramic tile.
If floors are covered with synthetic materials, the relative
humidity should be at least 50%.
Electrical fast transient /
burst IEC 61000-4-4
±2kV for power supply lines
±1kV for input / output lines
±2kV for power supply lines
There were no I/O lines
>3m in length
Mains power quality must be that of a typical commercial
or hospital environment.
Surge
IEC 61000-4-5
±1kV differential mode ±1kV differential mode Mains power quality must be that of a typical commercial or
hospital environment. There was no AC ground connection
to the unit.
Voltage dips, short
interruptions and voltage
variations on power supply
input lines
IEC 61000-4-11
<5% Vac (>95% dip in Vac)
for .5 cycle
40% Vac (60% dip in Vac)
for 5 cycles
70% Vac (30% dip in Vac)
for 25 cycles
<5% Vac
(>95% dip in Vac)
for 5 seconds
<5% Vac (>95% dip in Vac)
for .5 cycle
40% Vac (60% dip in Vac)
for 5 cycles
70% Vac (30% dip in Vac)
for 25 cycles
<5% Vac
(>95% dip in Vac)
for 5 seconds
Mains power quality must be that of a typical commercial
or hospital environment. At 95% dip for 5 seconds, the
82-3190 cycled power but returned to normal operation
without the assistance of an operator. If the uses of the
Model 82-3190 require continued operation during power
mains interruptions, it is recommended that the
Model 82-3190 be powered from an uninterruptible
power supply or a battery.
Power Frequency
(50/60 Hz) magnetic field
IEC 61000-4-8
3 Amps/meter 3 Amps/meter Power frequency magnetic fields must be at levels
characteristic of a typical location in a typical commercial
or hospital environment.
Vac is the AC mains voltage prior to the application of the test level.
The Model 82-3190 HAKIM Programmer is intended for use in the electromagnetic environment specified below. The customer or user of the
Model 82-3190 must assure that it is used in such an environment.
Emission Test Compliance Electromagnetic Environment
RF Emissions CISPR 11 Group I The system does not emit electromagnetic energy in order to perform
its intended function.
RF Emissions CISPR 11 Class B The system is suitable for use at home settings.
Harmonic Emission
IEC 61000-3-2
Class A
Harmonic Emission
IEC 61000-3-3
Complies
The Model 82-3190 HAKIM Programmer is intended for use in the electromagnetic environment specified below. The customer or user must assure
that it is used in such environment.
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