DN:KD-927-SMSY01 V2.0 Operation Guide
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INTENDED USE
Fully Automatic Electronic Sphygmomanometer 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-44cm (approx. 8 21/32
″
-17 5/16
″
).
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 Sphygmomanometers 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), 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)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).