Withings The Smart Blood Pressure Monitor, Инструкция по эксплуатации

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P/N : BP-800
0434
Guarantee
This blood pressure monitor is guaranteed for 1 year from date of purchase. The guarantee
does not apply to damage caused by improper handling, damage from leaking batteries,
accidents, not following the operating instructions or alterations made to the instrument by
third parties.
* EN60601-1-2: 2007 / AC 2010: Medical electrical equipment: Part 1-2: General requirements for
basic safety and essential performance
* EN1060-4: 2004 Non-invasive sphygmomanometers. Test procedures to determine the overall
system accuracy of automated non-invasive sphygmomanometers.
* FCC 47 CFR PART 18: Electromagnetic Compatibility
*EN 60601-1-4 :1996 /A1:1999
Medical electrical equipment -- Part 1-4: General requirements for safety - Collateral standard:
Programmable electrical medical
*EN ISO10993-1:2009 Biological evaluation of medical devices - Part 1: Evaluation and testing
within a risk management process
*EN ISO13485:2003/AC : 2009 Medical devices - Quality management systems - Requirements for
regulatory purposes
* EN ISO14971:2009 Medical devices - Application of risk management to medical devices
* EN 980:2008 :Graphical symbols for use in the labeling of medical devices
* ANSI/AAMI SP10:2002/(R)2008 -Manual, electronic, or automated sphygmomanometers