DN:KD-322-SMSY01 V4.0
Operation Guide
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INTENDED USE
Semi-Automatic 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-48cm (approx. 8 21/32
” -18 29/32”).
CONTRAINDICATION
It is inappropriate for people with serious arrhythmia to use this electronic blood pressure
monitor.
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 Electronic Blood Pressure Monitor corresponds to the
below standards: IEC 60601-1:2005/EN 60601-1:2006/AC:2010 (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), 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), ANSI/AAMI
SP-10:2002+A1:2003+A2:2006.
