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MedSource HTD8813C - 7 - EMC Declaration; Guidance and Manufacturers Declaration - Electromagnetic Immunity

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14
7 – EMC Declaration
This equipment needs to be installed and put into service in accordance with the information
provided in the ACCOMPANYING DOCUMENTS; This product needs special precautions regarding
EMC and needs to be installed and put into service according to the EMC information provided, and
this unit can be aected by portable and mobile RF communications equipment.
Do not use a mobile phone or other devices that emit electromagnetic fields near the unit. This may
result in an incorrect operation of the unit.
Caution: This unit has been thoroughly tested and inspected to assure proper performance and
operation.
Caution: This machine should not be used adjacent to or stacked with other equipment and that if
adjacent or stacked use is necessary, this machine should be observed to verify normal operation in
the configuration in which it will be used.
Guidance and Manufacturer’s Declaration – Electromagnetic Immunity
The Non-Contact Infrared Body Thermometer is intended for use in the electromagnetic environments specified below. The
customer or user of the Non-Contact Infrared Body Thermometer should ensure that it is used in such an environment.
Power Frequency
(50 Hz/60 Hz)
Magnetic Field
IEC 61000-4-8
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
Immunity Test IEC 60601 Test Level
±6 kV contact
±8 kV air
±2 kV for power supply lines
±1 kV for input/output lines
±1 kV line(s) to line(s)
±2 kV for line(s) to earth
<5% UT (>95% dip in UT) for 0.5 cycle
40% UT (60% dip in UT) for 5 cycles
70% UT (30% dip in UT) for 25 cycles
<5% UT (>95% dip in UT) for 5 secs
3 A/m
Compliance Level
±6 kV contact
±8 kV air
Not Applicable
Not Applicable
Not Applicable
3 A/m
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
the Non-Contact Thermometer requires continued
operation during mains power interruption, it is
recommended that the device be powered from an
uninterruptable power supply or battery.
Power frequency magnetic fields should be at
levels characteristic of a typical location in a typical
commercial or hospital environment.
Note: UT is the AC mains voltage prior to application of the test level.

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