iHealth Neo BP5S Manuale d'uso - Pagina 12
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(2) This device must accept any interference received, including interference that may cause undesired
operation of the device.
This device complies with RSS-247 of industry Canada. Operation is subject to the condition that this device does not
cause harmful interference.
This Class B digital apparatus complies with Canadian ICES-003(Cet appareil numérique de classe B est conforme à
la norme NMB-003 du Canada).
This equipment complies with IC radiation exposure limits set forth for an uncontrolled environment. This equipment
should be installed and operated with minimum distance of 5mm between the radiator and your body. This
transmittermust not be co-located or operating in conjunction with any other antenna or transmitter.
Cet appareil est conforme à la norme (s) RSS exempte de licence d'Industrie Canada. Le fonctionnement est soumis
aux deux conditions suivantes:
(1) Cet appareil ne doit pas causer d'interférences nuisibles
(2) Cet appareil doit accepter toute interférence reçue, y compris les interférences susceptibles de provoquer un
fonctionnement indésirable de l'appareil.
Cet équipement est conforme aux limites d'exposition au rayonnement du CI établies pour un environnement non
contrôlé. Cet équipement doit être installé et utilisé à une distance minimale de 5mm entre le radiateur et votre corps.
Cet émetteur ne doit pas être co-situé ou fonctionner conjointement avec une autre antenne ou émetteur.
CE Statement
The CE Mark applies to products regulated by certain European health, safety and environmental protection
legislation. The CE Mark is obligatory for products it applies to: the manufacturer affixes the marking in order to be
allowed to sell his product in the European market.
Hereby,
[ANDON HEALTH CO.,
LTD.] declares that the equipment is in compliance with Directive 2014/53/EU.
The full text of the EU declaration of conformity is available at the following internet address: www.ihealthlabs.eu
The product is manufactured by
[ANDON HEALTH CO.,
LTD.], the address is:
No. 3 Jinping Street, YaAn Road,
Nankai District, Tianjin 300190, China.
OTHER STANDARDS AND COMPLIANCES
The Wireless Blood Pressure Monitor corresponds to the following standards:
IEC 60601-1Edition 3.1 2012-08/EN 60601-1:2006/A1:2013 (Medical electrical equipment
-- Part 1: General requirements for basic safety and essential performance);
IEC 60601-1-2:2014/EN 60601-1-2:2007/AC:2010(Medical electrical equipment -- Part
1-2: General requirements for basic safety and essential performance - Collateral
standard: Electromagnetic compatibility - Requirements and tests);
IEC80601-2-30:2009+AMD1：2013/EN 80601-2-30:2010/A1：2015(Medical electrical
equipment –Part 2-30: Particular requirements for the basic safety and essential
performance of automated non-invasive sphygmomanometers);
EN 1060-1: 1995 + A2: 2009 (Non-invasive sphygmomanometers - Part 1: General
requirements),;
EN 1060-3: 1997 + A2: 2009 (Non-invasive sphygmomanometers - Part 3: Supplementary
requirements for electro-mechanical blood pressure measuring systems);
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