Welch Allyn Holter System - User Manual - Manual (Page 57)

Directions for Use 53
Electromagnetic Emissions and Immunity Information
Electromagnetic Emissions
The Welch Allyn Holter Recorder is intended for use in the electromagnetic environment specified below. The customer or user of the Welch
Allyn Holter Recorder should assure that it is used in such an environment.
Emissions Test Compliance Electromagnetic Environment - Guidance
RF emissions
CISPR 11 Group 2 The Welch Allyn Holter Recorder must emit electromagnetic energy in order to perform
its intended function. Nearby electronic equipment may be affected.
RF emissions
CISPR 11 Class B The Welch Allyn Holter Recorder is suitable for use in all establishments, including
domestic establishments. The recorder has no connection to the public low-voltage
power supply network.
Harmonic emissions
IEC 61000-3-2 Not applicable
Voltage fluctuations/
flicker emissions
IEC 61000-3-3 Not applicable
Electromagnetic Immunity
The Holter recorder is intended for use in the electromagnetic environment specified below. The customer or user of the Holter recorder 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 ± 6 kV contact
± 8 kV air
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 61000-4-4 ±2 kV for power supply
lines
±1 kV for input/output
lines Not applicable.
Surge
IEC 61000-4-5 ±1 kV differential mode
±2 kV common mode Not applicable.
Voltage dips, short
interruptions, and
voltage variations on
power supply input
lines.
IEC 61000-4-11 <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
Not applicable.
Power frequency
(50/60Hz)
magnetic field
IEC 61000-4-8 3 A/m Not applicable.
Note: U
T is the a.c. mains voltage prior to application of the test level.