Zimmer PremoPortFour, Инструкция по эксплуатации, Страница: 43 / 48

Manufacturer's EMC declaration
16
Page 37
Guidelines and manufacturer's declaration – Electromagnetic immunity
The PremoPort
Four
device is intended to be operated in an electromagnetic -
environment as indicated below. The customer or user of the PremoPort
Four
should
ensure that it is used in such an environment.
Immunity tests IEC 60601- test
level Compliance
level Electromagnetic
environment – Guidelines
Electrostatic
discharge (ESD)
according to
IEC 61000-4-2 ± 6 kV Contact
discharge
± 8 kV Air
-
discharge
± 8 kV
Air discharge Floors should be made of
wood or concrete or should
be covered with ceramic
tiles. If the floor is covered
with synthetic material, the
relative air humidity must be
at least 30%.
Rapid transient
electrical
disturbances/bursts
-
according to
IEC 61000-4-4
± 2 kV for
power cables
± 1 kV for input
and output
-
cables
Not applicable The quality of the supply
voltage should correspond
to that of a typical business
or hospital environment.
Surges according to
IEC 61000-4-5 ± 1 kV voltage
external
conductor-
external
conductor
± 2 kV voltage
external
conductor-
ground Not applicable The quality of the supply
voltage should correspond
to that of a typical business
or hospital environment.
Voltage dips, brief
interruptions and
-
fluctuations in the
supply voltage
according to
EN 61000-4-11
<5%
U
T
(>95%
dip in
U
T
) for ½
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
cycles
Not applicable The quality of the supply
voltage should correspond
to that of a typical business
or hospital environment. If
the user of the PremoPort
Four
requires continued
function even if interruptions
in the power supply occur, it
is recommended to power
PremoPort
Four
from an
uninterruptible power supply
or a battery.
Magnetic field at
power supply
frequency (50/60 Hz)
according to
IEC 61000-4-8 3 A/m 3 A/m Magnetic fields at the mains
frequency should
correspond to the typical
values found in a business
or hospital environment.
Note:
U
T
is the a.c. voltage prior to application of the test level.
Key performance features of the PremoPort
Four
are: smooth recording of
ambulatory blood pressure profiles, smooth operation of all functions.