Envitec MySign s - Page 54

Pulse oximeter MySign
®
S
Table 2 and 4: Guidance and manufacturer`s declaration - electromagnetic immunity
Guidance and manufacturer`s declaration electromagnetic immunity
The MYSIGN S is intended
for use in the electromagnetic environment specified below. The customer or the
user of the MYSIGN S 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
If floors are covered with synthetic
material, the relative humidity should
be at least 30 %.
Bursts
IEC 61000-4-4
± 2 kV power supply
lines
± 2 kV power
supply lines
Mains power quality should be that of a
typical commercial or hospital
environment.
Surges
IEC 61000-4-5
± 1 kV differential
mode
± 2 kV common
mode
± 1 kV differential
mode
± 2 kV common
mode
Mains power quality should be that of a
typical commercial or hospital
environment.
Voltage dips, short
interruptions and
voltage variations on
power supply input
lines IEC 61000-4-11
> 95 % dip in
U
T
/ 0,5 cycles
60 % dip in
U
T
/ 5 cycles
30 % dip in
U
T
/ 25 cycles
> 95 % dip in
U
T
/ 5 sec.
> 95 % dip in
U
T
/ 0,5 cycles
60 % dip in
U
T
/ 5 cycles
30 % dip in
U
T
/ 25 cycles
> 95 % dip in
U
T
/ 5 sec.
Mains power quality should be that
of a typical commercial or hospital
environment. If the user of the MYSIGN S
requires continued operation during
power mains interruption, it is
recommended that the [Equipment or
System] be powered from an UPS or
a battery.
magnetic field Power
frequency (50/60) Hz
magnetic field
IEC 61000-4-8
3 A/m
30 A/m
Power frequency magnetic fields should
be at levels characteristics of a typical
location in a typical commercial or
hospital environment.
Conducted RF
IEC 61000-4-6
V
1
= 3 V
150 kHz – 80 MHz
6 V
Portable and mobile communications
equipment should be used no closer to
any part of the MYSIGN S, including
cables, than the recommended
separation distance calculated from the
equation applicable to the frequency of
the transmitter.
d = 0.6 √P for V1 = 6 V
Radiated RF
IEC 61000-4-3
E
1
= 3 V/m
80 MHz – 2.5 GHz
20 V/m
d = 0.18 √P 80 MHz to 800 MHz
d = 0.35
√
P 800 MHz to 2,5 GHz
Field strengths from fixed RF transmitters,
as determined by an electromagnetic
site survey
a
, should be less than the
compliance level in each frequency
range. Interference
b
may occur in the
vicinity of equipment marked with the
following symbol:
54 066-07-1002197_GA_MySignS_FDA / 06.14