DN:KD-5985-SMSY01 V3.0 Operation Guide
Template version:1
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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-48cm/8 21/32
’’-18 29/32’’ (three kind of cuff circumference: 22cm-30cm/8
21/32
’’-11 13/16’’, 30cm-42cm/11 13/16’’-16 17/32’’(Optional), 42cm-48cm/16 17/32’’-18
29/32
’’(Optional)) .
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 monitor can also show the average reading of the
measurements. The voice function will ease the operation. The 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), IEC
80601-2-30
：
2009+Cor.2010/EN 80601-2-30:2010(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:
