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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 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
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 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 60601-1:2005/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: 2009 (Non-invasive sphygmomanometers
- Part 3: Supplementary requirements for electro-mechanical blood pressure
measuring systems).
ENGLISH
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