{ "ProductData": { "ID": "INS_2009", "ProductType": "Instrument", "BrandName": "cobas u 411 urine analyzer", "ProductNameAddition": "", "RegulatoryDisclaimer1": "For in vitro diagnostic use.", "DisclaimerGroup1": "IVD", "RegulatoryDisclaimer2": null, "DisclaimerGroup2": null, "RegulatoryDisclaimer3": null, "SampleType": [ ], "LicenseDisclaimers": [ ], "RelatedLinks": "", "Clone": "", "ControlTissue": [ "" ], "ISOtypes": "", "Species": [ "" ], "StainLocalization": [ "" ], "ProductNameGlobal": "cobas u 411" }, "ProductImageDetails": { "ImagePath": "https://pim-media.roche.com/Images/INS_2009_cobas_u_411.jpg", "ImageType": "Image main" }, "Product2Taxonomy": { "Product2TaxonomyReferences": [ { "StructureSystemIdentifier": "1", "StructureSystemName": "GPCH", "NodeID": "2159", "StructureNodeStatus": "", "NodeName": "" }, { "StructureSystemIdentifier": "OWP_Family", "StructureSystemName": "Product Families", "NodeID": "110", "StructureNodeStatus": "valid", "NodeName": "cobas" }, { "StructureSystemIdentifier": "OWP_Product_Types", "StructureSystemName": "Product Types", "NodeID": "10-000-00", "StructureNodeStatus": "valid", "NodeName": "Analyzer Instruments and Systems" }, { "StructureSystemIdentifier": "Lab_Type", "StructureSystemName": "Lab Types", "NodeID": "050-00", "StructureNodeStatus": "valid", "NodeName": "Core Lab" }, { "StructureSystemIdentifier": "Product_Solutions", "StructureSystemName": "Product Solutions", "NodeID": "120", "StructureNodeStatus": "valid", "NodeName": "Urinalysis" }, { "StructureSystemIdentifier": "Applications", "StructureSystemName": "Applications", "NodeID": "99-00-00", "StructureNodeStatus": "invalid", "NodeName": "" }, { "StructureSystemIdentifier": "OWP_Techniques", "StructureSystemName": "Techniques", "NodeID": "999-00", "StructureNodeStatus": "invalid", "NodeName": "" }, { "StructureSystemIdentifier": "Disease_Areas", "StructureSystemName": "Disease Areas", "NodeID": "99-00-00", "StructureNodeStatus": "invalid", "NodeName": "" }, { "StructureSystemIdentifier": "Pathogens", "StructureSystemName": "Pathogens", "NodeID": "99-00-00", "StructureNodeStatus": "invalid", "NodeName": "" }, { "StructureSystemIdentifier": "Health_Topics", "StructureSystemName": "Health Topics", "NodeID": "99-00-00", "StructureNodeStatus": "invalid", "NodeName": "" } ] }, "Product2Materials": { "P2MaterialReferences": [ { "MaterialNum": "04906969001", "MaterialDescription": "cobas u 411 urine analyzer", "RegisteredProductName": "cobas u 411 urine analyzer", "GTIN": "04015630925636", "ProductCategoryText": "Instruments", "OldMaterialNumber": "", "PackSizePIM360": "Not Available", "PackSizeDescPIM360": "Not Available", "MaterialAnnotation": "", "ReadyForUse": "", "OrderInformation": "" } ] }, "Product2Products": { "Product2ProductReference": [ ] }, "ProductSpec": [ { "ProductSpecVariant": { "Chapters": [ { "Name": "Intended Use", "Value": "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.", "Language": "en", "Country": "US", "Code": "Intended Use" }, { "Name": "Specification", "Value": "Analyzer specifications

System description	Continuous load urine analyzer for test strips	Parameters: Spec. gravity pH Leukocytes Nitrite Protein Glucose Ketone Urobilinogen Bilirubin Erythrocytes Color
Precision	Intra-System Precision Control Test M Inter-System Precision Control Test M	≤ 0.5% Remission ≤ 1.5% Remission
Robustness	accepted bending of test strips -wet -dry 2 mm	4 mm 2 mm
Software and data handling
CPUs	Software version 3.2: Intel XScale PXA255 Cygnal 8051 Software version 3.3: Intel XScale PXA168 Cygnal 8051
Operating system	LINUX
Memory	Software version 3.2: 32 MB Flash-Memory 32 MB DRAM Software version 3.3: 128 MB Flash-Memory 128 MB DRAM
Bus architecture	CAN fieldbus
Data storage internal external	Flash-Memory USB port
Interfaces	USB Port: 1 x USB RS232 ports: 3 x RS232 (Sediment Terminal, Barcode Scanner, Host)
Display	Software 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.
Printer	Internal thermal-printer (112 mm)
Samples
Sample handling	Manual by user
Throughput (theoretical throughput)	600 test strips per hour
Incubation time	60 seconds
Instrument cycle time	6.0 seconds
Calibration	Reference Strip on board for internal calibration Recommended calibration with calibration strip: once a month	Control Test M Control Test M
Measuring unit	Light source Wavelength Sensor	20 LEDs 470 nm, 555 nm, 620 nm 11 wide range photo sensors
Physical dimensions	Height Width Depth Weight	260-360 mm 425 mm  340-375 mm approx. 12 kg
Power requirements	Line voltage Line frequency Power Consumption Overvoltage Category Fuse	100 V – 125 V (-15% / +10%) and 200 V – 240 V (-15% / +10%) 50 Hz (+/- 5%) or 60 Hz (+/-5%) 60 VA II (IEC 61010-1) T 2.5A 250V
Environmental conditions	Temperature Running conditions Transportation and storage Humidity Running conditions Transporation and storage Pollution degree Altitude	15 – 32°C (59 – 89.6°F) -25 – 60 °C (-13 – 140 °F) 10% – 95% at no condensation 30% - 80%, non-condensing 10% - 95%, non-condensing 2 (IEC 61010-1) 0 – 2000 m, air pressure 80 to 106 kPa

", "Language": "en", "Country": "XG", "Code": "Specification" } ] } } ] }