Romtech CardiacConnect Cardiac 10300 Instructions For Use Manual page 17

CardiacConnect
Instructions for Use
IFU-10300, Rev. 1
Guidance and Manufacturers Declaration – Electromagnetic Immunity
The ROMTech CardiacConnect
below. The customer or the user of the ROMTech CardiacConnect
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 lines
IEC 61000-4-11
TM
Rehabilitation System Model 10300
TM
is intended for use in the electromagnetic environment specified
IEC 60601
Test Level
±4 kV air
±8 kV Contact
±2 kV for power
supply lines
100 kHz repetition
frequency
±1 kV line to line
±0.5kV line to line
0%, ½ cycle at 0°, 45°,
90°, 135°, 180°, 225°,
270°, 315°
0%, 1 cycle.
70%, 30 cycles
0%, 300 cycles
Page 17 of 25
TM
should assure that it is used in
Compliance
Level
±4 kV air
±8 kV Contact
Not applicable
Not applicable
Not applicable
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%
Not applicable
Not applicable
Not applicable