Intended Use; Contraindication; Product Description - Gima KD-595 Guía De Uso

Intended uSe

fully automatic 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 upper arm. the cuff circumference
is limited to 22cm-48cm (approx. 8 21/32"~18 29/32").
z

contraIndIcatIon

It is inappropriate for people with serious arrhythmia to use
this electronic blood pressure monitor.
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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 60 measurements can be stored in the memory with date
and time stamp. the voice function will ease the operation. the Electronic
blood pressure monitor 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), 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), anSI/aamI Sp-10:2002+a1:2003+a2:2006.
ENGLISH
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