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38
Guidance and manufacturer’s declaration - electromagnetic immunity
The HIVADOT® is intended for use in the electromagnetic environment specified
below. The customer or the user of HIVADOT® 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
±8 kV contact
±8 kV
contact
Floors should be wood,
concrete or ceramic tile.
If floor are covered with
synthetic material, the
relative humidity should
be at least 30%.
±2,4,8,15 kV air
±2,4,8,15
kV air
Electrical fast
transient/burst
IEC 61000-4-4
±2 kV for power
supply lines
±2 kV for
power
supply lines
Main power quality should
be that of a commercial or
hospital environment.
±1 kV for input/
output lines
Surge IEC
61000-4-5
± 0.5kV, ± 1 kV line(s)
to lines
± 0.5kV, ± 1
kV line(s) to
lines
± 0.5kV, ± 1 kV, ± 2
kV line(s) to earth
Voltage dips,
short interrup-
tions and volt-
age variations
on power supply
input lines IEC
61000-4-11
0% U
T
; 0.5 cycle
(0°,45°, 90°,135°,180°,
225°,270° and 315°)
0% U
T
; 1 cycle and
70% U
T
; 25/30 cycles
Single phase: at 0°
0% U
T
; 250/300
cycles
0% U
T
;
0.5 cycle
(0°,45°,
90°,135°,
180°,225°,
270° and
315°)
0% U
T
; 1 cy-
cle and 70%
UT; 25/30
cycles
Single
phase: at 0°
0% U
T
;
250/300
cycles
Mains power quality
should be that of a
typical commercial or
hospital environment. If
the user of the HIVADOT®
requires continued
operation during power
mains interruptions, it is
recommended that the
HIVADOT® be powered
from an uninterruptible
power supply or a battery.
Summary of Contents for HIVADOT
Page 1: ...DEEP OSCILLATION THERAPY DEVICE INSTRUCTION MANUAL A...
Page 44: ...44...
Page 45: ...45...
Page 46: ...46...
Page 47: ...47...
Page 48: ...Manufactured for 3541 22 04 A 2022 Compass Health Brands Corp Made in China...