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INTENDED USE
Fully Automatic Electronic 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 wrist.
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 voice function will ease the operation. The Electronic
Sphygmomanometers corresponds to the below standards: IEC 60601-1:2005
corr.1(2006)+corr.2(2007)/EN 60601-1
:
2006/A11: 2011 (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).