5
CONTRAINDICATION
Itisinappropriateforpeoplewithseriousarrhythmiatousethis
ElectronicSphygmomanometer.
PRODUCT DESCRIPTION
BasedonOscillometricmethodologyandsiliconintegratedpressure
sensor,bloodpressureandpulseratecanbemeasuredautomacally
andnon-invasively.Thescreenwillshowbloodpressureandpulserate.
Themostrecent4×30measurementscanbestoredinthememorywith
dateandmestamp.TheElectronicSphygmomanometerscorresponds
tothebelowstandards:IEC60601-1:2005+A1:2012(E)/EN60601-
1:2006/A11:2011(Medicalelectricalequipment--Part1:General
requirementsforbasicsafetyandessenalperformance),IEC60601-
1-2:2014/EN60601-1-2:2015/AC:2010(Medicalelectricalequipment
--Part1-2:Generalrequirementsforbasicsafetyandessenal
performance-Collateralstandard:Electromagneccompability
-Requirementsandtests),IEC80601-2-30:2009+AMD1:2013/
EN80601-2-30:2010/A1:2015(Medicalelectricalequipment–Part
2-30:Parcularrequirementsforthebasicsafetyandessenal
performanceofautomatednon-invasivesphygmomanometers)EN
1060-1:1995+A2:2009(Non-invasivesphygmomanometers-Part
1:Generalrequirements),EN1060-3:1997+A2:2009(Non-invasive
sphygmomanometers-Part3:Supplementaryrequirementsfor
electro-mechanicalbloodpressuremeasuringsystems).ISO81060-2
:2013(Non-InvasiveSphygmomanometers-Part2:ClinicalValidaon
OfAutomatedMeasurementType).
CONTENTS AND DISPLAY INDICATORS
MX86005 - IFU - 11.2020.indd 5MX86005 - IFU - 11.2020.indd 5 2020/12/14 16:372020/12/14 16:37