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User’s
Manual for OMNI Express Patient Monitor
105
037.007.0001 Rev.2
EMC
The product is in radio-interference protection class A in accordance with EN55011. The
product complies with the requirements of standard EN60601-1-
2:2007 “Electromagnetic
Compatibility -
Medical Electrical Equipment”.
NOTE:
1) Using accessories, transducers and cables other than those specified may result in
increased electromagnetic emission or decreased electromagnetic immunity of the
patient monitoring equipment.
2) The device or its components should not be used adjacent to or stacked with other
equipment. If adjacent or stacked use is necessary, the device or its components
should be observed to verify normal operation in the configuration in which it will be
used.
3) The device needs special precautions regarding EMC and needs to be installed and
put into service according to the EMC information provided below.
4) Other devices may affect this monitor even though they meet the requirement of
CISPR.
5) When the inputted signal is below the minimum amplitude provided in technical
specifications, erroneous measurements could result.
Guidance and Declaration- Electromagnetic Emissions
The device is suitable for use in the electromagnetic environment specified below. The
customer of the user of the device should assure that it is used in such an environment.
Emission Tests
Compliance
Electromagnetic Environment-guidance
Radio
frequency
(RF)
emissions CISPR11
Group 1
The device 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.
RF Emissions CISPR 11
Class A
The device is suitable for use in all
establishments other than domestic and
those indirectly 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
ELECTROMAGNETIC IMMUNITY
This section constitutes the guidance and OMNI Express Patient Monitor
’s declaration
regarding electromagnetic immunity. The OMNI Express Patient Monitor is intended for
use in the electromagnetic environment specified below. The customer or the user of the
OMNI Express Patient Monitor should ensure that it is used in such an environment.
Immunity test
IEC
60601
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 floors are covered
with synthetic material, the relative
humidity should be at least 30%.