67
EN
MXA51006
(85956141BM03SJ)
15.1 EMISSIONS LIMITS BY ENVIRONMENT
Certifi cation performed by the notifi ed body EZÚ Prague No. 1014.
The product has been clinically evaluated and is notifi ed in the Register of
Medical Devices of the Czech Republic as a medical device class. IIb.
JABLOTRON ALARMS a.s. declares that the product BM-03 is designed and
manufactured in accordance with the harmonization legislation of the European Union:
Directive No. 93/42/EHS, as last amended. The original Declaration of Conformity is at
www.monitornanny.com
After use, the battery should not be thrown into the bin, but returned to a collection point.
Although it is free of any harmful materials, do not dispose of it in normal waste, but in
special containers or collection points for the disposal of small electrical equipment, or
hand it over to the dealer or directly to the manufacturer.
PRODUCTION, DISTRIBUTION AND SERVICE:
JABLOTRON ALARMS a.s.
Pod Skalkou 4567/33, 466 01, Jablonec nad Nisou, Czech Republic
www.monitornanny.com
Phenomenon
Professional medical facilities
a)
Home health care
a)
RF emissions propagated by
conduction and radiation
CISPR 11
CISPR 11
c) d)
Harmonic distortion
see IEC 61000-3-2
b)
see IEC 61000-3-2
Voltage fl uctuations and fl icker
see IEC 61000-3-3
b)
see IEC 61000-3-3
a) For information on the intended use environment.
b) This test is not applicable in this environment if the ME devices and ME systems used are connected to the
public power supply network and the power supply is otherwise within the scope of the basic EMC standard.
c) ME instruments and ME systems intended for use in aircraft must meet the requirements of RF EMISSIONS
pursuant to ISO 7137. The conducted RF EMISSION test is only performed for ME instruments and ME
systems that are intended for connection to an aircraft’s on-board network. ISO 7137 is identical to RTCA
DO-160: 1989 and EUROCARD ED-14C: 1989. The latest editions are RTCA DO-160G:2010 and EROCAE
ED-14G:2011. Therefore, section 21 (category M) of a newer edition, such as [39] or [40], should be used.
d) Standards applied for other modes or the EM transport environments for which they apply. Examples of
standards that could apply are CISPR 25 and ISO 7637-2.
15.
EMC OF A MEDICAL DEVICE
Summary of Contents for BM-03
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