Mediblink M520 - Manufacturers Declaration

19
EN
14. Manufacturer’s Declaration
M520 with MDI is intended for use in the electromagnetic environment specied
below. The customer or the user of M520 with MDI should assure that it is used
in such an environment.
Electromagnetic Emissions: (IEC60601-1-2)
Emission Test Compliance Electromagnetic Environment
RF emission CISPR 11 Group 1
M520 with MDI uses RF energy only for internal functions. Therefore, this RF
emission is extremely weak and there is little chance of it creating any kind of
interference whatsoever with nearby electronic equipment.
RF emissions CISPR 11 Class B
M520 with MDI is suitable for use in all establishments, including domestic
establishments and those directly connected to the public low voltage power supply
network that supplies buildings used for domestic purposes.
Harmonic emissions IEC 61000-3-2
Not applicable
Voltage uctuations / icker IEC 61000-3-3 Not applicable
Electromagnetic Immunity: (IEC60601-1-2)
Immunity test IEC60601-1-2 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
Floors should be wood, concrete or ceramic tile.
If oors are covered with synthetic material, the
relative humidity should be at least 30 %
Electric fast transient / burst
IEC 61000-4-4
±2 kV for power supply lines
±1 kV for input / output lines
Not applicable Mains power quality should be that of a typical
commercial or hospital environment.
Surge IEC 61000-4-5 ±1 kV di󰀨erential mode
±2 kV common mode
Not applicable 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
<5 % U
T
(95 % dip in U
T
) for 0.5 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 sec.
Not applicable Mains power quality should be that of a typical
commercial or hospital environment. If the
user of the upper arm style requires continued
operation during power mains interruptions, it is
recommended that M520 with MDI be powered
from an uninterruptible power supply or a battery.
Power frequency (50 / 60 Hz)
magnetic eld IEC 61000-4-8
3 A / m Not applicable Not applicable
Note: U
T
is the a.c. mains voltage prior to application of the test level.
Immunity test IEC60601-1-2 test level
IEC60601-1-2
test level
Electromagnetic environment – guidance
Conducted
RF IEC
61000-4-6
Radiated
RF IEC
61000-4-3
3 Vrms 150 kHz to 80 MHz
80% AM (2Hz)
3 Vrms 80 MHz to 2.5 GHz
80% AM (2Hz)
3 Vrms
3 V / m
Portable and mobile RF communications equipment should be
used no closer to any part of M520 with MDI, including cables,
than the recommended separation distance calculated from the
equation applicable to the frequency of the transmitter.
Recommend separation distance
3 V
d = 1.2×p
1 / 2
80 Mhz do 800 MHz
d = 2.3×p
1 / 2
MHz do 2.5 GHz
Where P is the maximum output power rating of the transmitter in
watts (W) according to he transmitter manufacturer and d is the
recommended separation distance in meters (m).
Field strengths from xed RF transmitters as determined by an
electromagnetic site survey
a
, should be less than the compliance
level in each frequency range
b
. Interference may occur in the vicinity
of equipment marked with the following symbol: