Pearl Edition

http://www.toshibamedicalsystems.com ©Toshiba Medical Systems Corporation 2017. All rights reserved. Design and speci cations subject to change without notice. MCACL0013EA 2017-08 TMSC/D/Printed in Japan

Toshiba Medical Systems Corporation meets internationally recognized standards for Quality Management System ISO 9001, ISO 13485. Toshiba Medical Systems Corporation Nasu Operations meets the Environmental Management System standard ISO 14001. TBA, Pearl Edition and Made for Life are trademarks of Toshiba Medical Systems Corporation. Other company and product names appearing in this document may be trademarks or registered trademarks of their perspective holders. Compactness and Safety

This compact system is designed to provide increased safety. The transparent top covers allow system operation to be viewed without opening the covers. The arms for the monitor and keyboard can be positioned flexibly and can be installed on the left or right of the system.

High Reliability

Final reaction volume of as low as 70 μL* The cuvette manufacturing process has been improved, producing hard-glass reaction cuvettes with high washing efficiency and minimized distortion. Measurement with a final reaction volume of as low as 70 μL is now possible. * Depending on the characteristics of the reagent, photometry may sometimes not be possible with this volume Minimum sample volume of as low as 1.0 μL The minimum sample volume has been reduced to 1.0 μL, which lowers the Streamlined system with patient burden. enhanced performance Exceptional Efficiency

“Pearl” in the name “Pearl Edition™” represents purity and a long healthy life. The HbA1c measurement unit* automates the complicated manual operations required for HbA1c This advanced system facilitates speedy and versatile measurement workflows measurement. and has both an attractive design and extremely reliable system performance. The sample (whole blood or blood cells) can simply be set in the system, and The system adapts to advancing clinical demands with flexibility and accuracy. the pretreatment step (hemolyzation) is performed automatically, making the procedure easy and efficient. * Option It is compact and easy to use, and provides an especially comfortable Sample carry-over of 0.1 ppm or less measurement environment. The improved sampling probe washing efficacy enables increased efficiency in the measurement environment. Division of samples is no longer necessary because the same sample can also be used in the immunoassay system. ™

Pearl Edition

2 3 Dual-disk double-circle sampler STAT position for measurement Swift and flexible measurement for increased measurement with top priority efficiency The STAT position is given higher priority A dual-disk double-circle universal than the urgent sample positions on the workflow through elegant and sampler, which can accept up to 100 disk sampler, and other measurements sample containers of various types, is are interrupted for this measurement. employed. The inner disk and outer disk The dedicated STAT position control smooth operation can be scanned separately, allowing screen simplifies operation. urgent sample processing and urgent rerun to be performed efficiently. Simple “Set and Go” operation permits a rapid processing speed of Samples with and without barcodes can Refrigerated sampler for control be set together for measurement. measurement at desired timing maximum 1200 tests/hour for up to 100 different types of tests. The refrigerated All the tests can be entrusted to the system with confidence. sampler provides dedicated positions for calibrators and controls, facilitating Refrigerated sampler interval control STAT position measurement. Scan switches

Universal sampler Dedicated adapters and cups for accurate measurement using the microvolume sampling function* The sampling reliability for microvolume Selection of optimal scan timing samples can be according to run environment improved by the The standard configuration includes the use of dedicated sample ID unit, enabling the support adapters and cups. of two scan modes: Scan on Scan * Option and Sampling-End Scan. Processing for additional samples can be started immediately during measurement, Easy-to-use inner disk cup without requiring operation from the holder plates console, reducing the processing time. Inner disk cup holder plates are Scanning is started immediately after the Scan on Scan provided, allowing sample cups to be instruction for scanning is issued. set directly, improving the operability Sampling-End Scan Scanning is started after the end of sampling. for calibration.

4 5 Smooth and efficient operational flow

The system incorporates advanced technologies to provide a smooth and efficient operational flow. It includes a highly reliable sample clot detection unit and reaction cuvettes with excellent washing efficiency. In addition, it provides extremely accurate test results and prepares reports promptly, making it a complete system with outstanding all-round performance.

Minimum sample volume of 1.0 μL Highly flexible reagent Durable hard-glass cuvettes Electrolyte measurement Piezoelectric stirrers for effective The low sample volume required for compartments that support that can be washed effectively unit provided in the standard mixing of the reaction liquid measurement reduces the patient various bottle sizes Hard-glass reaction cuvettes manufactured configuration The vibration-type stirrers use burden. The system supports bottle sizes of by casting are used. These cuvettes can The installed electrolyte measurement piezoelectric elements and mix the 20 mL, 50 mL, 55 mL, 70 mL, 90 mL, and be washed effectively and their need unit can simultaneously measure three reaction liquid effectively. Mixing 100 mL, and the use of mixed bottle for periodic replacement is reduced. electrolytes (Na+, K+, Cl-) in serum or and washing is completed in a sizes is possible. The reagent 1 carousel During analysis, the reaction cuvettes urine. It uses our unique integrated measurement cycle time of 4.5 seconds. accepts up to 65 reagent bottles* and are automatically multi-ion sensor, which has excellent The simple structure of the stirrer allows the reagent 2 carousel accepts up to 56 washed with deionized maintainability with easy replacement easy maintenance. reagent bottles*. Reagents from various water and two types procedures. manufacturers can be used. of detergents (acidic * When the 55-mL reagent bottle racks are used and alkaline) in preparation for the next measurement.

6 7 OSS* function for improved MultiAssay function for running Sophisticated and flexible processing efficiency multiple assays in the same The OSS function optimizes the reaction cuvette measurement order automatically Multiple wavelengths and read timings Versatile and adaptable measurement based on the information set for each can be set for each sample. With the measurement assay. Reagent carry- MultiAssay function, two or more over is minimized and processing assays can be run sequentially in the functions serving a wide range of efficiency is improved significantly. same reaction cuvette to improve * OSS: Optimized Sampling Sequence measurement efficiency.

clinical needs Example of measurement Assay A Assay B Flex Rate function for Abs decreasing the retest ratio Advanced functions have been incorporated to improve For high-concentration samples that measurement efficiency. Reruns can be performed automatically normally require retesting after dilution, and smoothly, enabling prompt reporting of the highly accurate the Flex Rate function calculates the concentration based on the data Time results obtained. acquired during the Flex Rate read SR1 R2

timing and reports the result. This Assays that can be run in sequence in the same reaction cuvette reduces the need for retesting after Example 1 Hb (hemoglobin) HbA1c dilution and allows prompt result reporting. Example 2 Total cholesterol LDL cholesterol

Flex Rate function

Abs 1 2 Automatic rerun function for retesting of the sample with the sample volume increased or decreased or with the sample diluted Time SR1 R2 Urgent rerun or standard rerun is 1 Flex Rate read timing 2 Main read timing performed based on the rerun logic check. The rerun sample volume is increased or decreased or the sample is Recalculation function for diluted for rerun automatically according calculation using different to the setting. An urgent rerun can be measurement conditions ordered by an external host computer. Recalculation of the measurement results based on different calibration curves and assay parameters is Process monitor for display of possible. This is particularly useful when the status of the tests currently evaluating new assays. being run The real-time status of the processes Cuvette Analyzer function from sampling to result reporting are displayed clearly on the screen. The for statistical analysis of operator can estimate the reporting measurements for research time for urgent samples by just The mean value, coefficient of variation, glancing at the display. standard deviation, and range can be calculated automatically for test replicates. This is particularly useful when conducting research. Stop Pause STAT Measurement

Urgent STAT Regular sample sample sample

8 9 Improved operational Pearl Edition ease and efficiency

Specifications Dimensions and mass with the HbA1c Number of tests performed simultaneously Up to 100 tests External dimensions Analyzer 1600 (W) × 850 (D) × 1220 (H) mm Maximum throughput Photometric tests: 800 tests/hour Console * Electrolyte tests: 600 tests/hour PC 200 (W) × 400 (D) × 360 (H) mm Measurement methods End assay, rate assay, ISE Mass Analyzer Approx. 570 kg measurement option Sample dispensing volume 1.0 to 35.0 μL (selectable in 0.1-μL steps) Console Approx. 50 kg** Sample clot detection function: Power supply Analyzer 200 VAC Provided in the standard configuration Console 100 VAC Carry-over between samples 0.1 ppm or less Power consumption Analyzer 3 kVA The HbA1c measurement option has been Reagent dispensing volume 20 to 345 μL/reagent Console 0.6 kVA (selectable in 1-μL steps) provided to meet advanced clinical requirements. * The monitor and the keyboard are installed on movable arms. Final reaction volume 70 to 360 μL The positions of the monitor and the keyboard can be adjusted as desired within the movement In addition, a sample clot detection function Sampler Dual-disk double-circle sampler ranges of the arms. (with independently driven disks) ** The console mass shown is the estimated mass when the platform for the PC, the arms for the is provided, enabling the highest level of Outer disk: 80 positions; monitor and keyboard, and the printer are included. measurement reliability to be maintained. Inner disk: 40 positions; Cup sensors: Provided in the standard configuration Example layout Sample ID unit: Provided in the standard configuration High-concentration Power distribution 3-pin outlet 3-pin outlet HbA1c measurement procedures STAT position 1 position waste tank board Automatic pretreatment Measurement Refrigerated sampler 6 positions Dispensing Sample containers Blood collection tubes, sample cups Drain Reagent compartments R1: 56 bottles (65 bottles maximum*) 500 Deionizer R2: 36 bottles (56 bottles maximum*) unit Sampling Reagent containers 20-mL, 50-mL, 55-mL, 70-mL, 90-mL, and 100-mL bottles PC Result output Reaction disk Discrete type 850 Reaction cuvettes Hard glass (light-path length: 5 mm) Whole blood Hemolyzation Reaction Reaction time Approx. 10 minutes NGSP Thermostatic control Isothermal water bath 200 1600 value Reaction temperature 37°C Stirring Piezoelectric stirrers (two) Piping Wavelengths 340 nm to 804 nm (16 fixed wavelengths) Unit: mm Power line Whole blood or Automatically S + R1 + R2 Photometric technique Reaction cuvette direct photometry, Signal line blood cells pretreated Total Hb + sample measurement monochromatic or bichromatic Pretreatment (hemolyzed) reagent HbA1c measurement measurement Online interface RS232C Blood cells Use only the specified detergents and ISE solution (all items should be genuine). * Contact us for more information on the reagents for HbA1c measurement. Data processing functions OSS, Smart Sampling, reaction time The use of detergents or an ISE solution other than those specified may lead to system malfunction course (33 points), recalculation, Flex Rate, or abnormal data. sheet form, calibration sheet, automatic The specifications and appearance are subject to change when improvements are made to the system. HbA1c measurement unit (option) featuring rerun, process monitor, skipping of automatic pretreatment of the sample insufficient sample, skipping of insufficienteagent, r display of remaining In the HbA1c measurement unit, the sample is pretreated Results obtained by TBA-120FR reagent volumes, reagent bottle vs. results obtained by HPLC (hemolyzed) automatically. HbA1c, photometric, and ISE : Sample tube with NaF changeover, reagent bottle sharing, : Sample tube with EDTA multipoint calibration curve, calibration assays can be performed in succession for a particular sample. 20.0 curve log, automatic calibration, reaction Sample clot detection can be performed when the whole test, carry-over pairs, extrapolation, 18.0 blood or blood cell sample is dispensed and when washing QC level selection, quality control (daily QC, monthly QC, real-time QC), 16.0 is performed, allowing the highest level of measurement automatic startup, automatic shutdown, accuracy to be maintained. 14.0 color correction, skipping of inappropriate cuvette, multisample measurement, Specifications for the HbA1c measurement unit 12.0 automatic sample dilution, Smart Report, user ID registration, Cuvette Analyzer, Maximum throughput Up to 200 tests/hour 10.0 (when only HbA1c tests are performed) MultiAssay, online absorbance data Final reaction volume 70 to 360 μL 8.0 transfer, online calibration data transfer Anticoagulant used EDTA or NaF * When the reagent racks for 55-mL bottles are used 6.0 Sample type Whole blood (uncentrifuged sample) or TBA-120FR (%) (NGSP value) n = 85 blood cells (obtained by centrifugation) 4.0 r = 0.9887 Options Sample dispensing volume for HbA1c assay 3.0 to 3.6 μL (selectable in 0.2-μL steps) Y = 1.0004x-0.115 Reagent dispensing volume 20 to 354 μL (selectable in 5-μL steps) 2.0 Microvolume sampling function support kit Reaction time Approx. 10 minutes 55-mL reagent bottle rack 0.0 Reagent bottle adapters (for 20-mL and 55-mL) Reaction temperature 37°C 0.0 2.0 4.0 6.0 8.0 10.0 12.0 14.0 16.0 18.0 20.0 Reagent barcode unit Method for maintaining isothermal conditions Isothermal water bath HPLC (%) (NGSP value) * The other specifications are the same as for the former TBA-120FR. HbA1c measurement unit

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