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iHealth Track - KN-550BT Manual

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This device bears the CE conformity mark. The quality of this wireless device has been veried and
conforms to the provisions of the IEC 60601-1:2005 corr.1 (2006) + corr.2 (2007)/EN 60601-1:2006/AC:2010
(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);IEC80601-2-30:2009+Cor.：2010 (Medical electrical equipment –Part 2-30:
Particular requirements for the basic safety and essential performance of automated non-invasive
sphygmomanometers).
R&TTE mention: Hereby, iHealth declares that the BP Track KN-550BT is in compliance with the essential
requirements and other relevant provisions of Directive 1999/5/EC. Directive 1999/5/EC Declaration of
Conformity and all iHealth certication and regulatory documents can be downloaded on the following
link: https://www.ihealthlabs.eu/support/certications.
For information regarding potential electromagnetic or other interference between the iHeath Track Blood
Pressure Monitor and other devices together with advice regarding avoidance of such interference, please
visit www.ihealthlabs.eu/support/electromagnetic. It is suggested that the Wireless Blood Pressure Monitor
should be operated at least 10 metres away from electric or wireless devices (e.g. routers, microwave oven,
etc.). 15
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