Electromagnetic Compliance (Emc) - Invacare Sonata Manual Del Usuario

Invacare® Sonata
Type B Applied Part
Applied Part complying with the specified requirements for
protection against electrical shock according to IEC60601-1.
(An applied parts is a part of the medical equipment which
is designed to come into physical contact with the patient
or parts that are likely to be brought into contact with
the patient.)
Sound level: 45 to 50 dB (A)

9.6 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 B
CISPR 11(partly)
Harmonic
emissions
Class A
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 60601–1–2 test level Compliance level
Electrostatic
± 6 kV contact
discharge (ESD)
± 8 kV air
IEC 61000-4-2
± 2 kV for power supply
Electrostatic
lines
transient / burst
± 1 kV for input/output
IEC 61000-4-4
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 for 5 cycles
on power supply
70% U
input lines
for 25 cycles
IEC 61000-4-11
< 5% U
for 5 sec
24
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.
± 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 ) 40% U
T T
)for 5 cycles
(30% dip in U ) 70% U
T T
for 25 cycles
(>95% dip in U ) < 5% U
T T
for 5 sec
* IPX6 classification means that the electrical system is
protected against water projected in powerful jets from any
direction.
The bed is not provided with a mains switch, so the
mains plug is the only separation from the mains.
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 )
Mains power quality should be that of a typical
T T
commercial or hospital environment. If the
user of the medical bed requires continued
(60% dip in U
T T
operation during power mains interruptions, it is
recommended that the medical bed be powered
from an un-interruptible power supply or a
(30% dip in U )
T T
battery.
U is the a. c. mains voltage prior to application
(>95% dip in U )
T
T T
of the test level.
1574228-E