ACIST CVi - Page 88

EMC Requirements
88 | English (USA) 2019-08 901418-003,01 ACIST | CVi® System User's Guide
10 EMC Tables
Guidance and Manufacturer’s Declaration—Immunity
e CVi system is intended for use in the electromagnetic environment specied below. e customer or
user of the CVi system should ensure that it is used in such an environment.
Immunity Test
IEC 60601
Test Level
Compliance
Level
Electromagnetic
Environment —Guidance
Electrostatic discharge (ESD)
EN/IEC 61000-4-2:2008 per
IEC 60601-1-2:2014 and
EN60601-2:2015 4th Edition
± 15 kV Air
± 8 kV Contact
Criterion A
Criterion A
Floors should be wood,
concrete or ceramic tile. If
oors are synthetic, the r/h
should be at least 30%.
Electrical fast transient/burst
EN/IEC 61000-4-4:2012
per IEC 60601-1-2:2014
and EN60601-1-2:2015
4thEdition
± 2 kV for power supply lines
± 1 kV for input/output lines
Criterion A
Criterion A
Mains power quality should be
that of a typical commercial or
hospital environment.
Surge
EN/IEC 61000-4-5:2005
+ Cor1:2009 per
IEC60601-1-2:2014
and EN60601-1-2:2015
4thEdition
± 1 kV Dierential Mode
± 2 kV Common Mode
Criterion A
Criterion A
Mains power quality should be
that of a typical commercial or
hospital environment.
Power frequency 50Hz
Voltage dips, short
interruptions and voltage
variations on power supply
input lines
EN/IEC 61000-4-11:2004
per IEC 60601-1-2:2014
and EN60601-1-2:2015
4thEdition
100% of VNOM for 10mSec
(0.5line cycle) at 0°, 45°, 90°,
135°, 180°, 225°, 270°, 315°
100% of VNOM for 20mSec
(1line cycle) at 0°.
30% of VNOM for 500mSec
(25line cycles) at 0°.
100% of VNOM for 5000mSec
(250 line cycles)
Criterion A
Criterion A
Criterion A
Criterion C
Mains power quality should be
that of a typical commercial or
hospital environment. If the
user of the CVi system requires
continued operation during
power mains interruptions, it
is recommended that the CVi
system be powered from an
uninterruptible power supply
or battery.
Power frequency 60Hz
Voltage dips, short
interruptions and voltage
variations on power supply
input lines
EN/IEC 61000-4-11:2004
per IEC 60601-1-2:2014
and EN60601-1-2:2015
4thEdition
100% of VNOM for 8.3mSec
(0.5line cycle) at 0°, 45°, 90°,
135°, 180°, 225°, 270°, 315°
100% of VNOM for 16.67mSec
(1line cycle) at 0°.
30% of VNOM for 500mSec
(30line cycles) at 0°.
100% of VNOM for 5000mSec
(300 line cycles)
Criterion A
Criterion A
Criterion A
Criterion C
Mains power quality should be
that of a typical commercial or
hospital environment. If the
user of the CVi system requires
continued operation during
power mains interruptions, it
is recommended that the CVi
system be powered from an
uninterruptible power supply
or battery.
Power Frequency
50/60 Hz
Magnetic Field
EN/IEC 61000-4-8 per
IEC60601-1-2:2014 and
EN 60601-1-2:2015
4thEdition
30 A/m Criterion A Power frequency magnetic
elds should be that of a
typical commercial or hospital
environment.