MXA51005
61
EN
Certifi cation performed by the notifi ed body EZU Prague No. 1014.
The product has been clinically evaluated and is registered by
the Ministry of Health 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/ECC, as last amended, when used as intended. 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 | [email protected]
14.
EMC OF A MEDICAL DEVICE
14.1
EMISSIONS LIMITS BY ENVIRONMENT
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) his 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 EMISSI )
ONS 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.