Guidelines And Manufacturer's Statement - Electromagnetic Compatibility - Innomed Medical HS112 C-1 User Manual

12-channel ecg device with 112 mm wide built-in printer, colour touch screen lcd display
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19. Guidelines and manufacturer's statement –
electromagnetic compatibility
Guidelines and manufacturer's statements – electromagnetic noise emission
ECG was manufactured for use within the electromagnetic environment stated below. Buyer or
HS112 C-1
user of the device
HS112 C-1
Noise emission test
RF emission
CISPR 11
RF emission
CISPR 11
Guidelines and Manufacturer's Statement – electromagnetic disturbance tolerance
ECG was manufactured for use within the electromagnetic environment stated below.
HS112 C-1
Buyer or user of the device
Test for disturbance
tolerance
Electrostatic discharge
(ESD)
IEC 61000-4-2
Burst
IEC 61000-4-4
Surge
IEC 61000-4-5
Voltage drop, short
term power
interruption and
electrical fast
transients on mains
cable
IEC 61000-4-11
Mains frequency
(50/60 Hz) magnetic
field
IEC 61000-4-8
N
: U
is the mains Voltage before applying the test level.
OTE
T
R-6730-EN02-E
HS112 C-1 User Manual
must ensure that the unit is operated within this environment.
Conformity
1st group
Class B
must ensure that the unit is operated within this environment.
HS112 C-1
As per IEC 60601
Test level
± 6 kV contact
± 8 kV air discharge
± 2 kV on mains cable
± 1 kV on input /
output cable
± 1 kV differential
mode
± 2 kV common mode
<5% U
T
(>95% voltage drop
compared to U
)
T
for a period of 0,5 40% period of
U
T
(60% voltage drop
compared to U
) for a
T
period of
5 70% U
T
(30% voltage drop
compared to U
) for a
T
period of
25 <5% U
T
(>95% voltage drop
compared to U
) for 5
T
s
3 A/m
Electromagnetic environment – guideline
absorbs RF energy only for its internal
HS112 C-1
operation: Therefore RF emission is very low, and it is
not probable that it would influence the operation of
other electric devices.
can be used in any institution directly
HS112 C-1
connected to non-residential
and residential low Voltage network.
Level of conformity
± 6 kV contact
± 8 kV air discharge
± 2 kV on mains cable
± 1 kV on input / output
cable
± 1 kV differential mode
± 2 kV common mode
<5% U
T
(>95% voltage drop
compared to U
) for a
T
0,5 40% U
T
(60% voltage drop
compared to U
) for a
T
period of
5 70% U
T
(30% voltage drop
compared to U
) for a
T
period of
25 <5% U
T
(>95% voltage drop
compared to U
) for 5 s
T
3 A/m
Electromagnetic environment –
guidelines
Floor covering must be made of
wood, concrete or tile. If the floor
covering is made of plastic, relative
humidity must be minimum 30%.
Quality of mains energy must
comply with the average of
commercial or hospital
environment.
Quality of mains energy must
comply with the average of
commercial or hospital
environment.
Quality of mains energy must
comply with the average of
commercial or hospital
environment.
If the user of
HS112 C-1
continuous operation in case of
power interruption we recommend
the use of USP or operating the
machine from battery.
Level of mains frequency magnetic
field must comply with the average
of commercial or hospital
environment at a characteristic
point.
requires
63/73

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