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Qardio Arm Manual

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Harmonisierte EN, die wesentliche Anforderungen nach Artikel 3.2 der
R&TTE-Richtlinie enthält
EN301489-1-3 V1.9.2:2011 Elektromagnetische Verträglichkeits- und
Funkspektrumsangelegenheiten (ERM); Elektromagnetische Verträglichkeit
(EMV) für Funkeinrichtungen und -dienste; Teil 1: Allgemeine technische
Anforderungen
EN301489-1-17 V2.2.1:2012 Elektromagnetische Verträglichkeits- und
Funkspektrumsangelegenheiten (ERM); Elektromagnetische Verträglichkeit
(EMV) für Funkeinrichtungen und -dienste; Teil 1: Allgemeine technische
Anforderungen
EN60601-1-2:2007/AC 2010: Medizinische elektrische Geräte: Teil 1-2:
Allgemeine Anforderungen an die grundlegende Sicherheit und die wesentlichen
Leistungsmerkmale –Ergänzungsnorm Elektromagnetische Verträglichkeit
EN 55011 Gruppe 1 Klasse B:2009+A1:2010: Industrielle, wissenschaftliche und
medizinische Geräte – Funkstörungen – Grenzwerte und Messverfahren
FCC Teil B 15B:2013 Elektromagnetische Verträglichkeit
FCC-Vorschrift Teil: 15.247 Kat.: DSS (Bluetooth) FCC-Vorschrift Teil: 15.247
Kat.: DTS (BT4.0)
EN ISO 10993-1:2009 Biologische Beurteilung von medizinischen Geräten
– Teil 1: Beurteilung und Prüfung im Rahmen eines Risikomanagementprozesses
(ISO 10993-1:2009)
ANSI/AAMI SP10:2002/A1 2003(R) 2008: Manuelle, elektronische oder
automatische Blutdruckmessgeräte
ANSI/AAMI/ISO 81060-2:2009 Nicht-invasive Blutdruckmessgeräte Teil2:
Klinische Validierung der automatischen Messbauart
FCC-ERKLÄRUNG
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.
… 27 …


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