Electromagnetic Compliance (Emc); Guidance And Manufacturer´s Declaration - Electromagnetic Immunity; Environmental Conditions - Invacare Medley Ergo Serie Manual Del Usuario

Invacare® Medley Ergo™
Type B Applied Part
Applied Part complying with the specified
requirements for protection against electrical shock
according to IEC 60601-1.
Sound level 45–50 dB
Degree of The control unit, external power supply, motors
and hand control are protected according to IPx4.
protection
(IPx4: The system is protected against water
splashed from any direction.)
The bed has no isolator (main switch). Disconnect the bed
by unplugging it from the mains socket.

7.6 Electromagnetic compliance (EMC)

Guidance and manufacturer´s declaration – electromagnetic emission
The medical bed is intended for use in the electromagnetic environment specified below. The customer or the user of the bed should assure
that it is used in such an environment.
Emissions test Compliance
RF emissions
Group I
CISPR 11(partly)
RF emissions
Class A
CISPR 11(partly)
Harmonic emissions
Class B
IEC 61000-3-2
Voltage fluctuations
/flicker emissions Complies
IEC 61000-3-3
Guidance and manufacturer´s declaration – electromagnetic immunity
The medical bed is intended for use in the electromagnetic environment specified below. The customer or the user of the bed should assure
that it is used in such an environment.
Immunity test IEC 60601 test level
Electrostatic
± 6 kV contact
discharge (ESD)
± 8 kV air
IEC 61000-4-2
Electrostatic ± 2 kV for power supply
transient / burst lines
IEC 61000-4-4 ± 1 kV for input/output lines
Surge ± 1 kV differential mode
IEC 61000-4-5 ± 2 kV common mode
< 5% U
for 0,5 cycle
Voltage dips, short
interruptions and 40% U
voltage variations on 5 cycles
power supply input
70% U
lines
25 cycles
IEC 61000-4-11
< 5% U
for 5 sec
Power frequency
(50/60 Hz) magnetic
3 A/m
field
IEC 61000-4-8
18
Electromagnetic environment - guidance
The medical bed uses RF energy only for its internal function. Therefore, its RF emissions are
very low and are not likely to cause any interference in nearby electronic equipment.
The medical bed 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.
Compliance level
± 6 kV contact
± 8 kV air
± 2 kV for power supply
lines
± 1 kV for input/output lines
± 1 kV differential mode
± 2 kV common mode
(>95% dip in U ) < 5% U
T T
for 0,5 cycle
(60% dip in U )for 40% U
T T
5 cycles
(30% dip in U ) for 70% U
T T
25 cycles
(>95% dip in U ) < 5% U
T T
for 5 sec
3 A/m

7.5 Environmental conditions

Temperature
Relative humidity
Atmospheric
pressure
Be aware that when a bed has been stored under low
temperatures, it must be adjusted to operating conditions
before use.
Electromagnetic environment — guidance
Floors should be wood, concrete or ceramic tile. If
floors are covered with synthetic material, the relative
humidity should be at least 30 %.
Mains power quality should be that of a typical
commercial or hospital environment.
Mains power quality should be that of a typical
commercial or hospital environment.
(>95% dip in U )
T T
Mains power quality should be that of a typical
commercial or hospital environment. If the user of the
(60% dip in U )for medical bed requires continued operation during power
T T
mains interruptions, it is recommended that the medical
bed be powered from an un-interruptible power supply
(30% dip in U ) for
T T
or a battery.
U is the a. c. mains voltage prior to application of the
T
(>95% dip in U )
T T
test level.
Power frequency magnetic fields should be at levels
characteristic of a typical location in a typical commercial
or hospital environment.
Storage and
Operation
transportation
-10°C to +50°C +5°C to +40°C
20% to 75%
800 hPa to 1060 hPa
1556305-F