For in vitro diagnostic use. Instrument cobas u 411 IVD cobas® u 411 urine analyzer INS_2009 04 906 969 001 4 906 969 001 04906969001 4906969001 04906969001 cobas u 411 urine analyzer cobas u 411 urine analyzer 04015630925636 Instruments Not Available Not Available The cobas u 411 urine analyzer is a semiautomated urinalysis system intended for the in vitro qualitative or semi-quantitative determination of urine analytes, including pH, leukocytes, nitrite, protein, glucose, ketones, urobilinogen, bilirubin, and blood, as well as specific gravity and color. These measurements are useful in the evaluation of renal, urinary, hepatic and metabolic disorders. This system is intended to be used by trained operators in clinical laboratories. en The cobas u 411 urine analyzer is a semi-automated, benchtop analyzer. It is designed to read the Combur10 Test M test strips which are marketed in the United States as the Chemstrip 10 UA test strips and Chemstrip10 MD test strips for urinalysis. This analyzer is intended for the measurement of bilirubin, blood, glucose, ketone, leukocytes, nitrite, pH,protein, specific gravity, urobilinogen and color (if selected). These measurements are useful in the evaluation of renal, urinary and metabolic disorders. Tests performed using the cobas u 411 are intended for prescription, in vitro diagnostic use only. Only trained personnel working in a professional laboratory environment may operate the cobas u 411 analyzer. en Analyzer specifications System descriptionContinuous load urine analyzer for test stripsParameters:Spec. gravitypHLeukocytesNitriteProteinGlucoseKetoneUrobilinogenBilirubinErythrocytesColorPrecisionIntra-System PrecisionControl Test MInter-System PrecisionControl Test M≤ 0.5% Remission≤ 1.5% RemissionRobustnessaccepted bending of test strips-wet-dry 2 mm4 mm2 mmSoftware and data handlingCPUs Software version 3.2:Intel XScale PXA255Cygnal 8051Software version 3.3:Intel XScale PXA168Cygnal 8051Operating systemLINUXMemorySoftware version 3.2:32 MB Flash-Memory32 MB DRAMSoftware version 3.3:128 MB Flash-Memory128 MB DRAMBus architectureCAN fieldbusData storageinternalexternalFlash-MemoryUSB portInterfacesUSB Port: 1 x USBRS232 ports: 3 x RS232 (Sediment Terminal, Barcode Scanner, Host)DisplaySoftware version 3.2: 5.7 inch (¼ VGA - 320 x 240 pixels) passive matrix touch screen, blue/white. Software version 3.3: 5.7 inch (¼ VGA - 320 x 240 pixels) passive matrix touch screen color.PrinterInternal thermal-printer (112 mm)SamplesSample handlingManual by userThroughput (theoretical throughput)600 test strips per hourIncubation time60 secondsInstrument cycle time6.0 secondsCalibrationReference Strip on board for internal calibrationRecommended calibration with calibration strip: once a monthControl Test MControl Test MMeasuring unitLight sourceWavelengthSensor20 LEDs470 nm, 555 nm, 620 nm11 wide range photo sensorsPhysical dimensionsHeightWidthDepthWeight 260-360 mm425 mm 340-375 mmapprox. 12 kgPower requirementsLine voltageLine frequencyPower ConsumptionOvervoltage CategoryFuse100 V – 125 V (-15% / +10%) and 200 V – 240 V (-15% / +10%)50 Hz (+/- 5%) or 60 Hz (+/-5%)60 VAII (IEC 61010-1)T 2.5A 250V Environmental conditionsTemperatureRunning conditionsTransportation and storageHumidityRunning conditionsTransporation and storagePollution degreeAltitude 15 – 32°C (59 – 89.6°F)-25 – 60 °C (-13 – 140 °F)10% – 95% at no condensation30% - 80%, non-condensing10% - 95%, non-condensing2 (IEC 61010-1)0 – 2000 m, air pressure 80 to 106 kPa en

cobas^® u 601 urine analyzer	cobas^® u 701 microscopy analyzer	cobas^® u 411 urine analyzer	Urisys^® 1100 analyzer
Automation
fully automated strip analyzer	fully automated sediment analyzer	Semi-automated bench top system	Semi-quantitative hand held device
Throughput
240 samples/hour	116 samples/hour	30-100 samples/day	50 samples/day
Test parameters
12	11	Combur-Test® strip: 10 parameters Micral-test® strip: Human Albumin	Combur-Test® strip: 10 parameters Micral-test® strip: Human Albumin

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