Important Information Required By The Fcc; Other Standards And Compliances - iHealth BP3 User Manual

IMPORTANT INFORMATION REQUIRED BY THE FCC

This device complies with Part 15 of the FCC Rules. Its operation is subject to the following two conditions:
(1) This device may not cause harmful interference, and
(2) this device must accept any interference received, including interference that may cause undesired operation.
Changes or modifications not expressly approved by iHealth Lab Inc. would void the user's authority to operate the product.
Note: This product 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 product 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 product 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.
This product complies with Industry Canada. IC: RSS-210
IC NOTICE
This device complies with Industry Canada licence-exempt RSS standard(s). Operation is subject to the following two conditi
ons:
(1) this device may not cause interference, and
(2) this device must accept any interference, including interference that may cause undesired operation of the device.
Le présent appareil est conforme aux CNR d'Industrie Canada applicables aux appareils radioexempts de licence. L'exploitation
est autorisée aux deux conditions suivantes :
(1) l'appareil ne doit pas produire de brouillage, et
(2) l'utilisateur de l'appareil doit accepter tout brouillage radioélectrique subi, même si le brouillage est susceptible d'en compromettre le fonctionnement.
The USB port for charging for charging only and can't be used to transfer data.
This product is approved in accordance to R&TTE directive transmitter.
Hereby, [iHealth Lab Inc.], declares that this [BP3L CORE] is in compliance with the essential
requirements and other relevant provisions of Directive 1999/5/EC. Directive 1999/5/EC
declaration of conformity can be downloaded on the following link :
https://www.ihealthlabs.eu/support/certications

OTHER STANDARDS AND COMPLIANCES

The Wireless Blood Pressure Monitor corresponds to the following standards:
IEC 60601-1:2005 corr.1(2006)+corr.2(2007)/EN 60601-1：2006/A11: 2011(Medical electrical equipment – Part 1: General
requirements for safety);
IEC 60601-1-2:2007 /EN 60601-1-2:2007 /AC:2010 (Medical electrical equipment – Part 1: General requirements for safety;
Collateral Standard-Electromagnetic compatibility - Requirements and tests);
EN 1060-1: 1995 + A1: 2002 + A2: 2009 (Non-invasive sphygmomanometers - Part 1: General requirements);
EN 1060-3: 1997 + A1: 2005 + A2: 2009 (Non-invasive sphygmomanometers - Part 3: Supplementary requirements for
electro-mechanical blood pressure measuring systems);
AAMI/ANSI 80601-2-30：2009/IEC 80601-2-30：2009+Cor.2010(Medical electrical equipment –Part 2-30: Particular
requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers).