For in vitro diagnostic use. Instrument CoaguChek XS Pro IVD CoaguChek® XS Pro system INS_2132 07 210 841 003 7 210 841 003 07210841003 7210841003 07210841003 CoaguChek Pro II Kit W-LAN DE CoaguChek Pro II 07613336163245 Meters Not Available Not Available 05 530 199 160 5 530 199 160 05530199160 5530199160 05530199160 CoaguChek XS Pro Kit USA CoaguChek® XS Pro system 00365702398108 Meters Not Available Not Available The CoaguChek® XS Pro system (CoaguChek XS Pro meter and CoaguChek XS PT Test strips) quantitatively determines prothrombin time (“PT”), using capillary blood or whole blood from a vein (nonanticoagulated venous whole blood). It is indicated for use by healthcare professionals. The system is ideally suited to monitor coagulation values in people who are taking oral anticoagulation medication (vitamin K antagonists, VKAs). en Measuring & sampling Detection systemAmperometric (electrochemical) determination of the PT/INR after activation of the coagulation with human recombinant thromboplastinUser interfaceFull graphical (TFT)Support and safety functionsQC lockout, Patient & User ID, protection with administrator ID, Barcode ScannerSample applicationOutside the meter, with top-and 2 sides (left or right)-dosing optionsOperating conditions Operating temperature+15°C to +32°C (59°F to 90°F)Operating humidity and altitude10 - 85% - 4300 mHandling- First option: Operate the monitor on a leveled surface, free of vibrations- Second option: Hold the monitor in your hand, so that it is roughly horizontalSample Material Sample typeFresh capillary whole blood or non-anticoagulated venous whole bloodSample size≥ 8 μlInterferencesRefer to the test strip package insertTest strips ISIApprox. 1.0Sensitivity to heparinNot at therapeutic levels, up to 0.8 I.U/ml for UFH and up to 2 anti-Xa.U/ml for LMWHQuality controlOn each strip, through the same channel as the blood passesStability21 months from production (+2°C to +30°C) en

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