For in vitro diagnostic use. Instrument CoaguChek XS Plus IVD CoaguChek® XS Plus system INS_805 05021537001 COAGUCHEK XS PLUS CARE KIT CoaguChek® XS Plus system 00365702164109 Meters Not Available Not Available The CoaguChek® XS Plus system (CoaguChek XS Plus 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 IDSample applicationOutside the meter, with top-and 2 sides (left or right)-dosing optionsMeasuring rangeINR: 0.8 - 8.0%Q: 120 - 5<br>SEC: 9.6 - 96Operating conditions Operating temperature+15°C to +32°C (59°F to 90°F)Operating humidity and altitude10% - 85% - 4300 m (14,000 ft)Handling- First option: Operate the monitor on a level surface, free of vibrations- Second option: Hold the monitor in your hand, so that it is roughly horizontalMeasuring range- INR: 0.8 - 8.0- %Q: 120 - 5- SEC: 9.6 - 96Memory- 2000 patient and 500 QC results with date and time- 60 code chip records- Operator lists with up to 5000 Operator IDs with corresponding 2nd ID- Patient lists with up to 4000 Patient IDs with corresponding 2nd and 3rd IDsInterfaceInfrared interfacePower options- Power supply adaptor: Input: 100 - 240 V / 50 - 60Hz / 400 mA; Output: 7.5 V DC/ 1.7 A- 4 x 1.5 V AA batteries (alkali - manganese)- Rechargeable battery pack (optional)Number of tests per set of batteriesApprox. 80 tests (approx. 60 tests per charging cycle if the rechargeable battery pack is used)Dimensions185 x 97 x 43 mmWeight311 g (without batteries)Sample 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 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