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Qardio Arm Manual

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Geharmoniseerde EN-norm welke invulling geeft aan de essentiële vereisten van
artikel 3.2 van de R&TTE-richtlijn
EN301489-1-3 V1.9.2:2011 Elektromagnetische compatibiliteit en
radiospectrumkwesties (ERM); Elektromagnetische compatibiliteit (EMC) norm
voor radioapparatuur en radiodiensten; Deel 1: Algemene technische vereisten
EN301489-1-17 V2.2.1:2012 Elektromagnetische compatibiliteit en
radiospectrumkwesties (ERM); Elektromagnetische compatibiliteit (EMC) norm
voor radioapparatuur en radiodiensten; Deel 1: Algemene technische vereisten
EN60601-1-2:2007 /AC 2010: Medische elektrische toestellen: Deel 1-2:
Algemene eisen voor basisveiligheid en essentiële prestaties - Secundaire norm:
elektromagnetische compatibiliteit
EN 55011 Groep 1 Klasse B:2009+A1:2010: Industriële, wetenschappelijke
en medische apparatuur - Radiostoringskenmerken - Grenswaarden
en meetmethoden
FCC deel B 15B:2013 Elektromagnetische compatibiliteit
Deel van de FCC-regel: 15.247 Cat: DSS (Bluetooth) Deel van de FCC-regel:
15.247 Cat: DTS (BT4.0)
EN ISO 10993-1:2009 Biologische beoordeling van medische hulpmiddelen-
Deel 1: Evaluatie en beproeving binnen een risicomanagement proces (ISO
10993-1:2009)
ANSI/AAMI SP10:2002/A1 2003(R) 2008: Handmatige, elektronische of
geautomatiseerde bloeddrukmeters
ANSI/AAMI/ISO 81060-2:2009 Niet-invasieve bloeddrukmeters Deel 2:
Klinische validatie van automatisch meettype
FCC-/IC-VERKLARINGEN
Federal Communications Commission (FCC) Statement 15.21
You are cautioned that changes or modifications not expressly approved by
the part responsible for compliance could void the user’s authority to operate
the equipment.
15.105(b)
This equipment has been tested and found to comply with the limits for a
Class B digital device, pursuant to part 15 of the FCC rules. These limits are
designed to provide reasonable protection against harmful interference in a
residential installation. This equipment generates, uses and can radiate radio
frequency energy and, if not installed and used in accordance with the
instructions, may cause harmful interference to radio communications. However,
there is no guarantee that interference will not occur in a particular installation.
If this equipment does cause harmful interference to radio or television
reception, which can be determined by turning the equipment off and on,
the user is encouraged to try to correct the interference by one or more of
the following measures:
-Reorient or relocate the receiving antenna.
-Increase the separation between the equipment and receiver.
-Connect the equipment into an outlet on a circuit different from that to which
the receiver is connected.
-Consult the dealer or an experienced radio/TV technician for help.
… 26 …


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Qardio Arm User Manual - English - 36 pages

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