DN:KD-752-SMSY01 V1.0 Operation Guide
3/19
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 wrist. The cuff circumference is
limited to
14cm-19.5cm(approx. 5 1/2
″
-7 11/16
″
).
PACKAGE CONTENTS
1 Wireless Blood Pressure Monitor With Attached Wrist Cuff
1 Operation Guide
1 Storage Case
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 4
×
60 measurements can be stored in the
memory with date and time stamp. The Electronic Sphygmomanometer corresponds to the
below standards: IEC 60601-1Edition 3.1 2012-08/EN 60601-1:2006/A1:2013 (Medical
electrical equipment -- Part 1: General requirements for basic safety and essential
performance), IEC60601-1-2:2014/EN 60601-1-2:2015 (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);ISO81060-2
：
2013(Non-Invasive Sphygmomanometers - Part
2: Clinical Validation Of Automated Measurement Type).
