For in vitro diagnostic use. Instrument CoaguChek INRange IVD CoaguChek® INRange INS_4107 07404379174 CoaguChek INRange Japan (Bulk) CoaguChek® INRange 07613336142073 Meters Not Available Not Available The CoaguChek® INRange system, consisting of the CoaguChek INRange meter and the CoaguChek XS® PT Test PST test strip, is intended for the determination of prothrombin time (PT) in fresh capillary blood. It is intended for use by properly selected and appropriately trained patients and their respective caregivers.The prothrombin time (PT) test is a general coagulation test to monitor Vitamin K Antagonist therapy.The CoaguChek INRange system is intended for single patient self-testing only. It is not intended for use in a professional setting. en Measuring & Sampling Detection systemAmperometric (electrochemical) determination of the PT time after activation of the coagulation with human recombinant thromboplastinUser interfaceIntuitive user interface with color display, on/off, enter, back, and up/down buttonSample applicationOutside the meter top-and 2 sides: left or right,-dosing options Operating conditionsOperating conditions Temperature+ 15°C to + 32°C (59°F to 90°F)Humidity10 - 85%Maximum altitude4300 m (14,000 ft)Placement-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 INR0.8 - 8.0InterfaceUSB (Type B) and BluetoothPowerBattery - Four 1.5v AAA alkali-manganese batteries# of tests per set of batteries:Up to 60 tests or 1 yearSize145 x 75 x 30 mmWeight135 g (without batteries)Memory400 Test ResultsAuto power offAuto off after 2 minutes of inactivitySample material Sample materialSample type: Fresh capillary 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)Display DisplayColorDisplay of target range en