ZOLL Medical I Ltd. U3CMCT Manual De Usuario
CMCT Monitoring System
Instructions for Use
Instructions for Use
Page 28 of 31
11
COMPLIANCES
11.1
ELECTRICAL SAFETY
•
The device complies with IEC/EN 60601-1, Edition 3.1 for general requirements of
medical electrical equipment safety:
-
Mode of operation: spot measurement
-
Degree of mobility: portable
•
The device complies with IEC 60601-1-11.
•
The device complies with IEC 60601-2-47.
•
The device complies with EC 57.
11.2
ELECTROMAGNETIC COMPATIBILITY (EMC)
•
The device complies with IEC 60601-1-2, Edition 4, Class B.
Guidance and Manufacturer’s Declaration – Electromagnetic Compatibility
Guidance and manufacturer’s declaration- electromagnetic emissions
The CMCT is intended for use in the electromagnetic environment specified below. The customer or
the user of the CMCT should assure that it is used in such an environment.
the user of the CMCT should assure that it is used in such an environment.
Emissions Test
Compliance
Electromagnetic environment-
guidance
RF emissions CISPR11
Class B
The CMCT isn’t suitable for
interconnection with other
equipment.
The CMCT is suitable for use in all
establishments other than
domestic establishments and those
directly connected to the public
low voltage power supply network
interconnection with other
equipment.
The CMCT is suitable for use in all
establishments other than
domestic establishments and those
directly connected to the public
low voltage power supply network
that supplies buildings used for
domestic purposes.
domestic purposes.
Conducted Emissions from AC main
CISPR 11
CISPR 11
Class B
Harmonic emissions IEC 61000-3-2
Class B
Voltage fluctuations/ flicker emissions
IEC 61000-3-3
IEC 61000-3-3
Class B