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AUTION EYE AI-4510 Urine Particle Analysis System is a fully automated urine particle analyzer for in vitro diagnostic use. AUTION EYE AI-4510 is intended for the quantitative measurement of red blood cells (WBC) and squamous epithelial cells (SQEC), the semi-quantitative measurement of bacteria (BACT) and crystals (CRYS) and the qualitative measurement of white blood cell clumps (WBCC), non-squamous epithelial cells (NSE), hyaline casts (HYAL), non-hyaline casts (NHC), yeast (YST), mucus (MUCS) and sperm (SPRM) in urine samples. A trained operator can set criteria for flagging speciment analyte image decisions should be reviewed and reclassified as necessary by a trained technologist. The AUTION EYE AI-4510 analyzer can be used as a standalone unit or combined with an AUTION MAX AX-4060 urine chemistry analyzer.

The AI-4510 System (AUTION EYE AI-4510) is a fully automated urine particle analyzer for in vitro diagnostic use that uses flow cell digital imaging technology in a clinical laboratory setting. Based on images captured in the flow method, the instrument automatically classifies the images of various formed elements. The AI-4510 System can quantitatively measure RBC, WBC, and SQEC; semi-quantitatively measure BACT, and CRYS; and qualitatively measure WBCC, NSE, HYAL, NHC, YST, MUCS and SPRM in urine samples. In addition, the AI-4510 System allows trained operators to manually review and reclassify all the element images collected by the system.

iQ200 System: The iQ200 automated urine microscopy system is an in vitro diagnostic device used to automate the complete urinalysis profile, including urine test strip chemistry panel and microscopic sediment analysis. Optionally, the iQ200 analyzer can be used as a stand-alone unit, or the results from the iQ200 analyzer can be combined with other urine chemistry results received from an LIS. It produces quantative or qualitative counts of all formed sediments present in urine, including cells, casts, crystals, and organisms. A competent human operator can set criteria for auto-reporting and flagging specimens for review. All instrument analyte image decisions may be reviewed and overridden by a trained technologist. iChemVELOCITY Automated Urine Chemistry System: The iChem VELOCITY automated urine chemistry system is an in vitro diagnostic device used to automate the urine chemistry analysis profile using iChem VELOCITY Urine Chemietry Strips. The iChemVELOCITY can be used as a stand-alone system, as well as in an iQ200 Series system, a configuration given the proprietary name iRICELL as it is designed to be hardware and software compatible with iQ200 Series systems. It produces quantitative results for specific gravity; semi-quantitative results for glucose, blood, leukocyte esterase, bilirubin, urobilinogen, pH, protein, ketones and ascorbic acid: and qualitative results for nitrite, color and clarity. iChemVELOCITY strips are intended for use only with the iChemVELOCITY analyzer. In particular, they are not intended for visual reading. The iChem VELOCITY is not intended to be used as a Point of Care (POC) analyzer. These measurements are used to aid in the diagnosis of metabolic disorders, kidney function anomalies, urinary tract infections, and liver function. Tests performed using the iChemVELOCITY are intended for clinical laboratory use and in vitro diagnostics use only.

The iQ200 System auto-identifies and processes specimens in 10-position racks by mixing. sampling, and analyzing automatically. The iQ200 Series Automated Urine Microscopy system presents a specimen sandwiched between enveloping layers of lamina to a microscope coupled to a CCD (charge coupling device) video camera. This lamination positions the specimen exactly within the depth of focus and field of view of the objective lens of the microscope. The iQ200 System provides automatic sample handling for automated intelligent microscopy and automatic analyte classification for improved data reporting, presentation and management. Specimens are aspirated by an autosampler rather than poured manually. Individual particle images are isolated within each frame. The Auto-Particle Recognition (APR) software, uses size, shape, contrast and texture features to classify each image into one of 12 categories: RBCs, WBCs, WBC Clumps, Hyaline Casts, Unclassified Casts, Squamous Epithelial Cells, Non-squamous Epithelial Cells, Bacteria, Yeast, Crystals, Mucus and Sperm. Additionally, 27 predefined sub-classifications are available for identifying specific types of casts, crystals, non-squamous epithelial, dysmorphic, and others. Particle concentration is calculated using the number of particles images and the volume analyzed. User-defined release criteria are checked and results are sent to an operator review screen or directly uploaded to the LIS based on these criteria. Specimen results can be edited, imported, and exported. The iQ Body Fluids Module is a software program that runs on the iQ Series Systems and automates body fluid sample handling, capturing particle images in a manner similar to that of the urinalysis application. The iQ200 Series System uses a CCD camera to capture images from each sample. The iChemVELOCITY is an automated urine chemistry system performing measurements of defined physical and chemical constituents in urine. The system utilizes iChemVELOCITY urine chemistry test strips which are read in the Strip Reader Module (SRM) by measuring light reflectance. The device is a fully automated, computer-controlled urine chemistry analyzer intended for use only with iChemVELOCITY Urine Chemistry Strips for the measurement of ten urine chemistry analytes from the chemistry strip plus the measurement of specific gravity using an electronic refractometer assembly and the qualitative measurement of color and clarity by optical absorbance and scattering methods, respectively. It produces quantitative results for specific gravity; semi-quantitative results for glucose, blood, leukocyte esterase, bilirubin, urobilinogen, pH, protein, ketones and ascorbic acid; and qualitative results for nitrites, color and clarity. The primary function of the iQ200 and iChemVELOCITY analyzers is to process samples and provide results to the workstation. The primary functions of the workstation are: user interface, system control, results processing, data storage, and external communications. The analyzers run embedded code on micro controllers and the workstation software runs Microsoft Windows 7 or Windows XP Operating System (OS). The workstation can be connected to: A printer for creating reports; A Laboratory Information System (LIS) for receiving test orders and releasing results.

The cobas u 701 microscopy analyzer is a fully automated urine microscopy system intended for the in vitro quantitative determination of erythrocytes and leukocytes, the semi-quantitative determination of squamous epithelial cells, bacteria, and hyaline casts and the qualitative determination of non-squamous epithelial cells, crystals, yeasts, mucus and sperm in urine. This system is intended to be used by trained operators in clinical laboratories. All instrument analyte image decisions may be reviewed and reclassified by a trained operator.

The cobas u 701 microscopy analyzer is a fully automated urine analysis system. It is optimized for the high-volume professional laboratory market. The cobas u 701 microscopy analyzer performs a maximum theoretical throughput of up to 116 samples per hour. The cobas u 701 microscopy analyzer consists of several major components: - Rack transport system - Liquid handling system - Cuvette cassette compartment - Centrifuge - Built-in reverse microscope with movable objective lens for focusing procedure - High resolution camera system - Touch Screen - Inbuilt Computer with the imaging and evaluation software for analyzing the sediment pictures Key functions include sample loading and transport, sample identification, sample homogenization, sample pipetting into cuvettes, centrifugation of cuvettes, image acquisition with a camera, image assessment, automatic disposal of used cuvettes, result readout, result and image memory, optional manual classification and / or re-classification of particles, manual or Automatic validation of the result, optional formats for data output including electronic result communication, data export, remote service, quality control, processing of diluted samples, washing, filling water tank, emptying liquid and solid waste. The cobas u cuvette is used by the cobas u 701 microscopy analyzer to transport, centrifuge and analyze patient and control samples. No calibration of the device is necessary for its intended use. However, there is a microscope check utilizing a reference cuvette.

The Sysmex® UF-5000 Fully Automated Urine Particle Analyzer is an automated urine particle analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. The Sysmex® UF-5000 Fully Automated Urine Particle Analyzer analyzes the following parameters in urine samples: RBC, WBC, Epithelial cells, Cast, Bacteria and flags the presence of the following: Pathologic Cast, Crystals, Sperm, Yeast like cell and Mucus.

The Sysmex® UF-5000 Fully Automated Urine Particle Analyzer is an automated urine particle analyzer that is used in the clinical laboratory to analyze formed elements in urine samples quantitatively and flag for the presence of particles/cells in the sample. It provides screening of abnormal samples, as well as automation and better efficiency in the laboratory. The analyzer reports analysis results on five enumerated parameters in urine: RBC (Red Blood Cells), WBC (White Blood Cells), EC (Epithelial Cells), CAST and BACT (Bacteria). It also reports flagging information on the following parameters in urine: Pathologic Cast; Crystal; Sperm; Yeast like cell; and Mucus. This flagging information alerts the operator for the need of further testing and/or review. The Sysmex® UF-5000 Fully Automated Urine Particle Analyzer is a dedicated system for the analysis of microscopic formed elements in urine and uses a Microsoft® Windows Operating System. The analyzer consists of the following units: (1) Main Unit which aspirates, dilutes, mixes and analyzes urine samples and processes data from the main unit and provides the operator interface with the system; (2) Sampler Unit which supplies samples to the main unit automatically; and (3) Pneumatic Unit which supplies pressure and vacuum to the main unit. The analyzer uses five reagents-UF-CELLSHEATH (sheath reagent), UF-CELLPACK CR and UF-CELLPACK SF (diluents) and UF-Fluorocell CR and UF-Fluorocell SF (both stains). The quality control material is UF-CONTROL.

The iQ 200 System is intended for analysis of urine chemistry, specific gravity, and formed sediment elements, which constitutes typical routine urinalysis. Urinalysis is ordered by physicians as a screening procedure for detection of possible abnormal metabolic or systemic disease, indicated by chemical composition of urine, and of potential renal or urinary tract disease or dysfunction, indicated by urine concentration and by the nature and distribution of urinary formed elements. Urine profile testing is commonly employed in the initial clinical evaluation of patients admitted for hospital care or undergoing physical examinations. Routine urinalysis is also indicated in diagnosis of patients with possible renal or urinary tract infection, carcinoma, or other injury, as well as for monitoring the status and effectiveness of drug, radiation, or dietary therapy, and of post-surgical or posttherapeutic recovery. The information produced by the iQ 200 System concerning the composition of patient urines is ordered at the discretion of the physician, and is part of a larger body of laboratory and other test results available to assist the physician in health assessments or differential diagnoses. Routine urinalysis findings are always subject to judgment and interpretation by physicians relative to the patient's overall clinical presentation and history.

The iQ 200 System is an in-vitro diagnostic device used to automate the complete urinalysis profile, including urine test strip chemistry panel and microscopic sediment analysis. Optionally, the iQ 200 Analyzer can be used as a stand-alone unit, or the results from the iQ 200 Analyzer can be combined with other urine chemistry results received from an LIS. It produces quantitative or qualitative counts of all formed sediment elements present in urine, including cells, casts, crystals, and organisms. A competent human operator can set criteria for auto-reporting and flagging specimens for review. All instrument analyte image decisions may be reviewed and overridden by a trained technologist. The iQ Lamina Cradle is a new accessory to be used with the iQ Series of Urine Microscopy Analyzers (K022774). The iQ Lamina Cradle is connected to the iQ Series via a 5V DC USB bus, and is under software control of the desktop computer that is part of the iQ Series. The cradle contains a RFID transceiver and antenna. In simple terms, it recognizes a legitimate IRIS RFID tag embedded in the container label of each 7 liter iQ Lamina Bottle. The software tracks the consumption of iQ Lamina. Visual warning and error messages are displayed as flags in the system software. Audio alerts are communicated through the cradle's speaker. The tracking will alert the operator when a bottle is empty or when a bottle not containing an Iris RFID chip is being used.

The Sysmex® UF-500i is an automated urine particle analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. The UF-500i analyzes the following parameters in urine samples: RBC, WBC, Epithelial Cells, Cast, and Bacteria and flags the presence of the following: Pathologic Cast, Crystal, Sperm, Small Round Cell, Yeast like cell and Mucus.

The Sysmex® UF-500i, an automated urine particle analyzer, is a dedicated system for the analysis of microscopic formed elements in urine specimens. The instrument consists of three principal units: (1) Main Unit which aspirates, dilutes, mixes and analyzes urine samples; (2) Auto Sampler Unit supplies samples to the Main Unit automatically; (3) IPU (Information Processing Unit) which processes data from the Main Unit and provides the operator interface with the system. The UF-500i is equipped with a Sampler that provides continuous automated sampling for up to 60 tubes. The instrument utilizes Sysmex flow cytometry using a red semiconductor laser for analyzing organized elements of urine. Particle characterization and identification is based on detection of forward scatter, fluorescence and adaptive cluster analysis. Using its own reagents, the UF-500i automatically classifies organized elements of urine and carries out all processes automatically from aspiration of the sample to outputting the results. Analysis results and graphics are displayed on the IPU screen. They can be printed on any of the available printers or transmitted to a Host computer.

Sysmex® UF-1000i is an automated urine particle analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. The UF-1000i analyzes the following parameters in urine samples: RBC, WBC, Epithelial Cells, Cast, and Bacteria and flags the presence of the following: Pathologic Cast, Crystal, Sperm, Small Round Cell, Yeast like cell and Mucus.

The Sysmex® UF-1000i, an automated urine particle analyzer, is a dedicated system for the analysis of microscopic formed elements in urine specimens. The instrument consists for three principal units: (1) Main Unit which aspirates, dilutes, mixes and analyzes urine samples; (2) Auto Sampler Unit supplies samples to the Main Unit automatically; (3) IPU (Information Processing Unit) which processes data from the Main Unit and provides the operator interface with the system. The UF-1000i is equipped with a Sampler that provides continuous automated sampling for up to 50 tubes. The instrument utilizes Sysmex flow cytometry using a red semiconductor laser for analyzing organized elements of urine. Particle characterization and identification is based on detection of forward scatter, fluorescence and adaptive cluster analysis. Using its own reagents, the UF-1000i automatically classifies organized elements of urine and carries out all processes automatically from aspiration of the sample to outputting the results. Analysis results and graphics are displayed on the IPU screen. They can be printed on any of the available printers or transmitted to a Host computer.

The Sysmex® UF-1000i is an automated urine particle analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. The UF-1000i analyzes the following parameters in urine samples: RBC, WBC, Epithelial Cells, Cast, and Bacteria and flags the presence of the following: Pathologic Cast, Crystal, Sperm, Small Round Cell, Yeast like cell and Mucus.

The Sysmex® UF-1000i, an automated urine particle analyzer, is a dedicated system for the analysis of microscopic formed elements in urine specimens. The instrument consists for three principal units: (1) Main Unit which aspirates, dilutes, mixes and analyzes urine samples; (2) Auto Sampler Unit supplies samples to the Main Unit automatically; (3) IPU (Information Processing Unit) which processes data from the Main Unit and provides the operator interface with the system. The UF-1000i is equipped with a Sampler that provides continuous automated sampling for up to 50 tubes. The instrument utilizes Sysmex flow cytometry using a red semiconductor laser for analyzing organized elements of urine. Particle characterization and identification is based on detection of forward scatter, fluorescence and adaptive cluster analysis. Using its own reagents, the UF-1000i automatically classifies organized elements of urine and carries out all processes automatically from aspiration of the sample to outputting the results. Analysis results and graphics are displayed on the IPU screen. They can be printed on any of the available printers or transmitted to a Host computer.

The Sysmex® UF-100i is an automated urine cell analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. The UF-100i analyzes the following parameters in urine samples: RBC, WBC, Epithelial Cells, Cast, and Bacteria and flags the presence of the following: Pathologic Cast, Crystal, Sperm, Small Round Cell, Yeast like cell.

The Sysmex® UF-100i, automated urine cell analyzer is a dedicated system for the analysis of microscopic formed elements in urine specimens. It accomplishes this by the principles of Laser Flow Cytometry and Impedance. The UF-100i attached to a commercially available reagent strip reader provides all that is required to perform an automated urinalysis profile consisting of chemistries and microscopic results.

The iQ 200 System is intended for analysis of urine chemistry, color, clarity, specific gravity, and formed sediment elements, which constitutes typical routine urinalysis. The iQ 200 System is an in-vitro diagnostic device used to automate the complete urinalysis profile, including urine test strip chemistry panel and microscopic sediment analysis. Optionally, the iQ 200 Analyzer can be used as a stand-alone unit, or the results from the iQ 200 Analyzer can be combined with other urine chemistry results received from an LIS. It produces quantitative or qualitative counts of all formed sediment elements present in urine, including cells, casts, crystals, and organisms. A competent human operator can set criteria for auto-reporting and flagging specimens for review. All instrument analyte image decisions may be reviewed and overridden by a trained technologist. The iQ 200 System is intended for analysis of urine chemistry, specific gravity, and formed sediment elements, which constitutes typical routine urinalysis. Urinalysis is ordered by physicians as a screening procedure for detection of possible abnormal metabolic or systemic disease, indicated by chemical composition of urine, and of potential renal or urinary tract disease or dysfunction, indicated by urine concentration and by the nature and distribution of urinary formed elements. Urine profile testing is commonly employed in the initial clinical evaluation of patients admitted for hospital care or undergoing physical examinations. Routine urinalysis is also indicated in diagnosis of patients with possible renal or urinary tract infection, carcinoma, or other injury, as well as for monitoring the status and effectiveness of drug, radiation, or dietary therapy, and of postsurqical or post-therapeutic recovery. The information produced by the iQ 200 System concerning the composition of patient urines is ordered at the discretion of the physician, and is part of a larger body of laboratory and other test results available to assist the physician in health assessments or differential diagnoses. Routine urinalysis findings are always subject to judgment and interpretation by physicians relative to the patient's overall clinical presentation and history.

The iQ 200 System provides automatic sample handling for automated intelligent microscopy and automatic analyte classification for improved data reporting, presentation and management. Specimens are aspirated by an autosampler rather than poured manually. Each image is analyzed and assigned a classification by an auto analyte recognition algorithm. Using these classifications and the known observation volume, microscopic analyte concentrations may be automatically reported. If results from a specimen are not autoreported, microscopic examination results are displayed on an independent Computer WorkStation. Operators can then confirm or modify analyte classifications and release reports off-line for enhanced convenience, obviating the need to process a second aliquot for review. Chemistry results from the companion ARKRAY AUTION MAX AX-4280 are automatically consolidated by the Computer WorkStation for display and reporting.