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INTENDED USE
Fully Automatic Electronic Sphygmomanometer is for use by medical profes-
sionals 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 inatable
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
Sphygmomanometer
PACKAGE CONTENTS
1 Blood Pressure Monitor
1 Operation Guide
1 Arm Cuff
1 Soft Storage Case
PRODUCT DESCRIPTION
Based on Oscillometric methodology and silicon integrated pressure sensor,
blood pressure and pulse rate can be measured automatically and non-inva-
sively. The LCD display will show blood pressure and pulse rate.
The most recent 2x60 measurements can be stored in the memory with date
and time stamp. The monitor can also show the average reading of the last
three measurements. The Electronic Sphygmomanometers 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 ba-
sic 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: Particu-
lar 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 measur-
ing systems). ISO81060-2 :2013(Non-Invasive Sphygmomanometers - Part 2:
Clinical Validation Of Automated Measurement Type)
ENGLISH
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