Itamar Medical EndoPAT 2000, Руководство по эксплуатации

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Itamar Medical Ltd.
Endo PAT
TM
x Device 74 Operation Manual
APPENDIX C: MANUFACTURING DECLARATIONS ACCORDING
TO IEC 60601-1-2
Electromagnetic Compatibility
Notes

The
EndoPAT
TM
x
requires special precautions with regard to electromagnetic
compatibility.

It must be installed and prepared for use as described in section 3 - Installing the System.

Certain types of mobile telecommunication devices such as mobile telephones are likely to
interfere with the
EndoPAT
TM
x.

The recommended separation distances in this paragraph must therefore be complied with.

The
EndoPAT
TM
x
must not be used near or on top of another device. If this cannot be
avoided, it is necessary - before clinical use – to check the equipment for correct operation
under the conditions of use.

The use of accessories other than those specified or sold by Itamar Medical as replacement
parts may have the consequence of increasing the emissions or decreasing the immunity of
the unit.
Electromagnetic Emissions

EndoPAT TM x is intended for use in the electromagnetic environment specified in the
following tables 1, 2, 3, 4, 5, 6 and 6a below.

The user and/or installer of the unit must ensure that it is used in such an environment.
Table 1 – from IEC 60601-1-2:2014
Guidance and manufacturer's declaration – electromagnetic emissions – EndoPAT
TM
x (EPX)
The EDx is intended for use in the electromagnetic environment specified below; The customer or the user of the EPX should assure that it is
used in such an environment.
Emissions test Compliance Electromagnetic environment - guidance
RF emissions CISPR 11 Group 1 Class B
The EPX 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.
Harmonic emissions
IEC 61000-3-2
Class B
The EPX 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.
Voltage fluctuations/ flicker
emissions
IEC 61000-3-3
Complies