Instruction For Use PMH7000
Version 2
Revision 03 23 July 2019
Page 8 of 20
As there is requirement under IEC 60601-1-2: 2007 that the detailed information on EMC environmental conditions shall
be provided to the user so as to make the device being operated safely, the technical explanation relating EMC
standards are described below. (For further details, please refer to IEC 60601-1-2: 2007).
■ Technical Information on EMC (Electromagnetic Compatibility)
Electro-medical equipment requires an adequate attention to EMC standard and specifications, and shall be used under
the following instructions.
NOTE:
・
The device requires an adequate attention to EMC standards and specifications, and shall be used under the EMC
information described in this section.
・
The device may be affected by other portable and mobile RF communication equipments.
Guidance and manufacturer
’s declaration – electromagnetic emissions
The PMH7000 is intended for use in the electromagnetic environment specified below. The customer or the user of the
PMH7000 should assure that it is used in such an environment.
Emission test
Compliance
Electromagnetic environment - guidance
RF emissions
CISPR 11
Group 1
The PMH7000 uses RF energy only for its internal function.
Therefore, its RF emission are very low and are not likely to cause
any interference in nearby electronic equipment.
RF emissions
CISPR 11
Class
B
The PMH7000 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
Class A
Voltage fluctuations/
flicker emissions
IEC 61000-3-3
Complies
Guidance and manufacturer
’s declaration – electromagnetic immunity
The PMH7000 is intended for use in the electromagnetic environment specified below. The customer or the user of the
PMH7000 should assure that it is used in such an environment.
Immunity test
IEC 60601-1 test
level
Compliance
level
Electromagnetic environment - guidance
Electrostatic
discharge(ESD)
IEC 61000-4-2
±
6kV contact
±
8kV air
±
6kV contact
±
8kV air
Floor should be wood, concrete or ceramic tile.
If floors are covered with synthetic material,
the relative humidity should be at least 30%.
Electrical fast transient /
burst
IEC 61000-4-4
±
2kV for power
supply lines
±
1kV for
input/output lines
±
2kV for power
supply lines
N/A*
Mains power quality should be that of a typical
commercial or hospital environment.
Surge
IEC 61000-4-5
±
1kV line(s) to
line(s)
±
2kV line(s) to
earth
±
1kV line(s) to
line(s)
±
2kV line(s) to
earth
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 cycle
70%
U
T
(30 % dip in
U
T
)
for 25 cycle
<5%
U
T
(>95 % dip in
U
T
)
for 5s
<5%
U
T
(>95 % dip in
U
T
)
for 0.5 cycle
40%
U
T
(60 % dip in
U
T
)
for 5 cycle
70%
U
T
(30 % dip in
U
T
)
for 25 cycle
<5%
U
T
(>95 % dip in
U
T
)
for 5s
Mains power quality should be that of a typical
commercial or hospital environment. If the user
of the PMH7000 requires continued operation
during power mains interruptions, it is
recommended that the PMH7000 be powered
from an uninterruptible power supply or
battery.
