Intended Use; Contraindication; Product Description - Gima KD-558 Gebrauchsanweisung

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 (approx. 8 21/32"~18 29/32").
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CONTRAINDICATION

It is inappropriate for people with serious arrhythmia to use
this Electronic Sphygmomanometer
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IVD
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PRODUCT DESCRIPTION

PHTHALATES
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 60601-1Edition 3.1 2012-08/EN 60601-1:2006/
A1:2013 (Medical electrical equipment -- Part 1: General requirements
for basic safety and essential performance), IEC60601-1-2:2007/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),
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 + 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).
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