Operator Manual Helena C-Series Family Helena C-1 • Helena C-2 • Helena C-4
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Operator Manual Helena C-Series Family Helena C-1 • Helena C-2 • Helena C-4 - 1

Helena Biosciences Operator Manual: Helena C-1, Helena C-2, Helena C-4 Operator Manual Helena C-Series Family Helena C-1 • Helena C-2 • Helena C-4 For In-Vitro Diagnostic use Instrumentation and reagents for human coagulation and haemostasis Copyright © 2020, Helena Biosciences Europe

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Operator Manual Helena C-Series Family Helena C-1 • Helena C-2 • Helena C-4 - 2

Helena Biosciences Operator Manual: Helena C-1, Helena C-2, Helena C-4 Operator Manual Revision First edition Minor updates throughout prior to the first distribution of the instrument. Correction to accessories listed on page 9.

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Operator Manual Helena C-Series Family Helena C-1 • Helena C-2 • Helena C-4 - 3

Helena Biosciences Operator Manual: Helena C-1, Helena C-2, Helena C-4 Copyright © 2020 by Helena Biosciences Europe; Neither the Operator's Manual nor any part thereof may be copied, digitally processed or otherwise transferred without written permission from Helena Biosciences Europe. The software for Helena Biosciences Europe products is the intellectual property of Helena Biosciences Europe, which the company retains all rights to usage of the software. The purchaser of a Helena C-Series instrument acquires rights of use for this software Helena C-Series is a trademark of Helena...

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Operator Manual Helena C-Series Family Helena C-1 • Helena C-2 • Helena C-4 - 4

Helena Biosciences Operator Manual: Helena C-1, Helena C-2, Helena C-4

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Operator Manual Helena C-Series Family Helena C-1 • Helena C-2 • Helena C-4 - 5

Helena Biosciences Operator Manual: Helena C-1, Helena C-2, Helena C-4

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Operator Manual Helena C-Series Family Helena C-1 • Helena C-2 • Helena C-4 - 6

Helena Biosciences Operator Manual: Helena C-1, Helena C-2, Helena C-4

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Operator Manual Helena C-Series Family Helena C-1 • Helena C-2 • Helena C-4 - 7

Helena Biosciences Operator Manual: Helena C-1, Helena C-2, Helena C-4 INTRODUCTION This device left the factory in fault-free condition regarding its safety and engineering functionality. To maintain this condition and ensure risk-free operation, the operator must comply with the safety warnings and information in this Operator's Manual. Use the Helena C-Series only in compliance with the instructions in this Operator's Manual. Otherwise, the manufacturer shall exclude the liability for any damages to the Helena C-Series, patients or operators. SYMBOLS The following standard symbols are...

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Operator Manual Helena C-Series Family Helena C-1 • Helena C-2 • Helena C-4 - 8

Helena Biosciences Operator Manual: Helena C-1, Helena C-2, Helena C-4 VIEWS OF THE DEVICE Home Screen Coloured Touch Display Complete area is prewarmed to 37°C 1 x Reagent position Ø24mm 2 x Reagent position Ø22mm (1 position will be stirred on Helena C-2 and Helena C-4) 2 x Reagent positions Ø13mm 10 x Cuvette incubation positions (x20 on Helena C-2 and Helena C-4) 1 x Cuvette measurement positions (x2 for Helena C-2, x4 for Helena C-4) FIGURE 1: TOP VIEW – HELENA C-1 5V: PC: SERVICE: PRINTER: BARCODE: Power in LIS or PC Software update Serial printer Handheld barcode scanner (serial)...

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Operator Manual Helena C-Series Family Helena C-1 • Helena C-2 • Helena C-4 - 9

Helena Biosciences Operator Manual: Helena C-1, Helena C-2, Helena C-4 CONSUMABLES / ACCESSORIES Helena C-Series products available REF C-1X Single Cuvettes (Voucher) Stir Bars Reagent Container (22.5mm) Reagent Tube (11.0mm) Reagent Adapter 22.5 – 24.2mm Display Protection Foil TECAM Smart Software Thermal Printer Thermal Printer Paper Barcode Scanner Download cable Interface Cable Description 1 x single channel semi-automated coagulation analyser with starter kit. 1 x two channel semi-automated coagulation analyser with starter kit. 1 x four channel semi-automated coagulation analyser...

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Operator Manual Helena C-Series Family Helena C-1 • Helena C-2 • Helena C-4 - 10

Helena Biosciences Operator Manual: Helena C-1, Helena C-2, Helena C-4 INTENDED USE The Helena C-Series is designed to carry out blood coagulation tests such as PT, APTT, TT, Fibrinogen, single factor tests, chromogenic and immunoturbidometric tests (Antithrombin, D-dimer etc.) on human citrated plasma. The instrument must be used for the intended purposes and good technical condition maintained as described in this document. It is designed for use in a laboratory or clinical environment by trained operators. It is not intended for home use. 1.4.1 COMPARISON OF THE HELENA C-SERIES FAMILY...

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Operator Manual Helena C-Series Family Helena C-1 • Helena C-2 • Helena C-4 - 11

Helena Biosciences Operator Manual: Helena C-1, Helena C-2, Helena C-4 Software features Reagent Dual LOT manage two different lots for each test Test Calibration LOT, expiry and up to 5 points for each test Result Database save recent 100 results onboard Double Determination Run patient twice and display mean value Stopwatch function count up or down incubation time Result Identification Patient ID or sample ID or Auto ID Real Time Clock Start test at reagent addition No additional starter pipette required Visualise Reaction Curve TECAM Software required Link to LIS over USB or...

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Operator Manual Helena C-Series Family Helena C-1 • Helena C-2 • Helena C-4 - 12

Helena Biosciences Operator Manual: Helena C-1, Helena C-2, Helena C-4 1.4.2 TEST METHODS The following tests are provided to detect defects of the human coagulation system, which can be bleeding or thrombosis and the monitoring of anticoagulation drugs like Heparin or Warfarin. Test Helena C-Series Prothrombin Time Activated Partial Prothrombin Time Thrombin Time Factors II, V, VII, VIII, IX, X, XI, XII Protein C Lupus Screen Lupus Confirm 1.4.3 SPECIMEN COLLECTION Type: Collection: Centrifugation: Storage: Human citrated plasma Vein puncture, 1:10 mixed sodium citrate 3.2% (0.105M) 10min...

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Operator Manual Helena C-Series Family Helena C-1 • Helena C-2 • Helena C-4 - 13

Helena Biosciences Operator Manual: Helena C-1, Helena C-2, Helena C-4 1.4.4 MEASUREMENT PRINCIPLE The detection of plasma clotting is based on a photometric principle. No mechanical aids like mixing bars are required. Blood plasma is filled into a cuvette. Special reagents are added, which initiate the blood coagulation. The cuvette is transmitted by ultraviolet light during the coagulation process. When the sample starts to clot a change of light absorbance is measured. The time from measurement start, to change of light (turning point) is called clotting time and expressed in seconds...

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Operator Manual Helena C-Series Family Helena C-1 • Helena C-2 • Helena C-4 - 14

Helena Biosciences Operator Manual: Helena C-1, Helena C-2, Helena C-4 1.4.5 CLOTTING METHOD (PT, APTT,..) FIGURE 4: DETERMINATION OF TURNING POINT IN CLOTTING METHOD The final reaction in the coagulation cascade is the transformation of fibrinogen into fibrin catalysed by thrombin. Fibrin formation increases turbidity of the sample, which is measured by the photometer and stored as the extinction. The result in seconds is the time from the start of the reaction to the time of half rate of change (50% point). 1.4.6 CHROMOGENIC METHOD (ANTITHROMBIN): The change of optical signal is not...

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