cobas u 601 urine analyzer Providing precise and secure test results

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Providing precise and secure test results 1 of 6

Providing precise and secure test results cobas u 601 urine analyzer is a modular, analytical system platform for urine strip testing and features a fully automated solution for laboratories processing 100 1,000 urine samples per day cobas u 601 urine analyzer automates all manual steps and delivers high quality results by proven unique reagent strip design based on 50 years of experience in urine analysis and innovation, minimizing operator intervention while providing confidence in results cobas u 601 stand-alone analyzer can be upgraded on-site with the cobas u 701 module* (automated sediment microscopy) to an urine work area one platform with automated sample transportation through the entire system, with continuous loading of urine samples * In development 2 of 6

At a glance 2 1 4 3 1 cobas u 601 user interface Operates on a 19 touch screen, designed for ease of use and intuitive navigation Intuitive user interface helps the operator use the instrument correctly, and also means effective operation, less training required helping staff management Customized and assisted result management, improves TAT and optimizes workflow Convenient QC management by consolidation of QC data and results on a single platform, all the QC information can be viewed on screen including QC chart without any manual entry 2 cobas u 601 module Fully automated urine test strip analysis Throughput of up to 240 samples/hour Uses reagent strip (cobas u pack) with ascorbic acid resistance cobas u pack: 400 strips/casette with RFID labelling New techonology of photometer for strip reading: an image sensor (camera chip) performs reflectance photometric measurements on each test pad of a test strip with 4 wavelengths. The new technolgy allows the differentiation of intact and lysed erythrocytes up to 50 E/µL, avoids the measuring failures caused by dust, low sample volume or wrong test strip positioning, etc. to assure reliable results 12 parameters: ph, leukocytes, nitrite, protein, glucose, ketones, urobilinogen, bilirubin, and erythrocytes, gravity, color and clarity 3 Input buffer 4 Output buffer Loading capacity of 75 samples (15 racks/ tray, 5 samples/rack), continuous loading of urine samples Automatically starts operation after routing and priority or emergency samples loading 3 of 6

Technical specifications System Modular, analytical system platform for urine strip test, expandable and re-configurable on site with cobas u 701 module* to urine work area Types of module cobas u 601 module: urine strip measuring unit Module combinations Stand-alone: cobas u 601 urine analyzer with one cobas u 601 module Sample throughput: Up to 240 samples/hour with test strip analysis Incubation time: 60 seconds Cycle time: 15 seconds Test parameters ERY Erythrocytes and hemoglobin LEU Leukocytes NIT Nitrite PRO Protein GLU Glucose KET Ketones UBG Urobilinogen BIL Bilirubin ph SG Specific gravity COL Color CLA Clarity Consumables cobas u pack: cassette with 400 strips for urine strip analysis Onboard stability of cobas u pack is 14 days Sample input/outupt Load/unload capacity: 75 samples (= 15 racks), continuous loading/unloading Rack: 5 position rack, RD standard rack Tray: tray with 15 racks/75 samples, RD standard tray Automatically starts operation after routing, priority or emergency samples loading Sample container types Length: 65 115 mm. Diameter: 13 16 mm. Bottom: round, conical or false Minimal sample volume Test strip: 2.0 ml Test strip reduced volume (no measuring cell measurements): 1.5 ml Measurement principles Reflectance photometry: with 4 different wavelengths (465, 528, 560 and 615 nm) Refractometry: SG testing Turbimetry: clarity testing Calibration cobas u calibration strip for urine strip analysis Storage capacity Test results: up to 10,000 test results QC, photometer calibration and measuring cell calibration: up to 300 for each Operator can export all results on the analyzer, including QC and calibration results Power requirements Line voltage: 100 125 VAC, permanent connection (+10%, -15%) 200 240 VAC, permanent connection (+10%, -15%) Line frequency: 50 or 60 Hz (±5%) Regulatory requirements The cobas u 601 urine analyzer meets the protection requirements laid down in IVD Directive 98/79/EC. Furthermore, our instruments are manufactured and tested according to the following international standards: IEC 61010-1, 2 nd Edition IEC 61010-2-081, 1 st Edition IEC 61010-2-101, 1 st Edition CAN/CSA C22.2 No. 61010 2 nd Edition EN IEC 61326-1 1 st Edition EN IEC 61326-2-6 1 st Edition Operating conditions Ambient room temperature 18 to 32 C (64.4 to 90 F) Relative humidity 30 % 80 %, non condensing Physical dimensions Width (with buffers) 107.9 cm (42.48 in) Width (without buffers) 68.7 cm (27.05 in) Depth 53.2 cm (20.94 in) Height 64.4 cm (25.35 in) Weight Weight (with buffers) 92.7 kg (207.5 lb) Weight (without buffers) 80.5 kg (177.47 lb) * In development 4 of 6

50 years of experience, proven test strip technology and performance, combined with regular improvements and ongoing innovation for true confidence in results. Providing precise and secure test results Proven Combur-Test strip technology: 50 years of successful history in urine diagnostics Comparable results with same technology across all Roche urinalysis systems for efficient back-up and network solutions. Unique reagent strip construction: Ascorbic acid resistance for proven high quality results Nylon mesh ensures uniform color development through uniform penetration of the urine into the test area, seperating different reagent papers in a test pad Protected results, reduced reaction time and increased storage life of the strip by proven design. New generation of strip test system: Innovation with the new photometer technology for the test strip result reading taking inhomogenous, highresolution images of each pad, detecting the intact and lysed erythrocytes Accurate, safe results by new technology. Easy to use: Convenient cassette concept cobas u pack, humidity protected with RFID technology Minimizing of operator intervention and enhancing productivity. 5 of 6

COBAS, COBAS U and LIFE NEEDS ANSWERS are trademarks of Roche. 2014 Roche Roche Diagnostics International Ltd CH-6343 Rotkreuz Switzerland www.cobas.com 6 of 6