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DN:KD-926-SMSY01 V1.0
Operation Guide

INTENDED USE

Fully Automatic Electronic Blood Pressure Monitor is for use by medical professionals or at
home and is a non-invasive blood pressure measurement system intended to measure the
diastolic and systolic blood pressures and pulse rate of an adult individual by using a
non-invasive technique in which an inflatable cuff is wrapped around the upper arm.The cuff
circumference is limited to 22cm-42cm(approx.8 21/32"-16 17/32").

CONTRAINDICATION

It is inappropriate for people with serious arrhythmia to use this Electronic
Sphygmomanometer.

PRODUCT DESCRIPTION

Based on Oscillometric methodology and silicon integrated pressure sensor, blood pressure
and pulse rate can be measured automatically and non-invasively. The LCD display will show
blood pressure and pulse rate. The most recent 2×60 measurements can be stored in the
memory with date and time stamp. The Electronic Sphygmomanometer corresponds to the
below standards:
IEC 60601-1:2005 +A1:2012(E)/EN 60601-1:2006/A11: 2011 (Medical
electrical equipment -- Part 1: General requirements for basic safety and essential
performance), IEC60601-1-2:2007/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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