Johnson & Johnson Codman HAKIM Mode D'emploi page 6

Table I Manufacturer's Declaration Regarding Electromagnetic Emissions
NOTE: Portable and mobile RF communication equipment can affect medical electrical equipment.
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.
Emission Test
RF Emissions CISPR 11
RF Emissions CISPR 11
Harmonic Emission
IEC 61000-3-2
Harmonic Emission
IEC 61000-3-3
Table II Manufacturer's Declaration Regarding Electromagnetic Immunity
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.
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
Vac is the AC mains voltage prior to the application of the test level.
205181-001-E.indd 6 205181-001-E.indd 6
Compliance
Group I
Class B
Class A
Complies
IEC 60601 Test Level Compliance Level
±6kV Contact ±6kV Contact
±8kV air ±8kV air
±2kV for power supply lines ±2kV for power supply lines
±1kV for input / output lines There were no I/O lines
>3m in length
±1kV differential mode ±1kV differential mode
<5% Vac (>95% dip in Vac) <5% Vac (>95% dip in Vac)
for .5 cycle for .5 cycle
40% Vac (60% dip in Vac) 40% Vac (60% dip in Vac)
for 5 cycles for 5 cycles
70% Vac (30% dip in Vac) 70% Vac (30% dip in Vac)
for 25 cycles for 25 cycles
<5% Vac <5% Vac
(>95% dip in Vac) (>95% dip in Vac)
for 5 seconds for 5 seconds
3 Amps/meter 3 Amps/meter
Electromagnetic Environment
The system does not emit electromagnetic energy in order to perform
its intended function.
The system is suitable for use at home settings.
Electromagnetic Environment Guidance
Floors should be wood, concrete or ceramic tile.
If floors are covered with synthetic materials, the relative
humidity should be at least 50%.
Mains power quality must be that of a typical commercial
or hospital environment.
Mains power quality must be that of a typical commercial or
hospital environment. There was no AC ground connection
to the unit.
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 magnetic fields must be at levels
characteristic of a typical location in a typical commercial
or hospital environment.
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