helena BioSciences C Series Operator's Manual
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helena BioSciences C Series Operator's Manual

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Helena Biosciences Operator Manual:
Helena C-1, Helena C-2, Helena C-4
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
HL-2-P-3448 Rev. 3
Operator Manual
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Summary of Contents for helena BioSciences C Series

  • Page 1 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 HL-2-P-3448 Rev. 3 Page 1...
  • Page 2 Helena Biosciences Operator Manual: Helena C-1, Helena C-2, Helena C-4 Updates Operator Manual Revision Date of Issue Amendments Rev.1 2019-12 First edition Rev. 2 2020-06 Minor updates throughout prior to the first distribution of the instrument. Rev.3 2020-07 Correction to accessories listed on page 9.
  • Page 3 The purchaser of a Helena C-Series instrument acquires rights of use for this software Trademarks Helena C-Series is a trademark of Helena Biosciences Europe. Other product names used in this Operator's Manual are trademarks of the respective companies.

  • Page 4: Table Of Contents

    Helena Biosciences Operator Manual: Helena C-1, Helena C-2, Helena C-4 Introduction ..........................7 Symbols ..........................7 Views of the device ......................8 Consumables / Accessories ....................9 Intended use ........................10 1.4.1 Comparison of the Helena C-Series Family ..............10 1.4.2 Test Methods ......................
  • Page 5 Helena Biosciences Operator Manual: Helena C-1, Helena C-2, Helena C-4 Hidden Functions ........................43 Reset to factory default ....................43 Working with TECAM Smart ....................44 Cleaning and maintenance ...................... 45 Cleaning .......................... 45 Decontamination ......................45 Regular maintenance ...................... 45 Appendix ..........................
  • Page 6 Helena Biosciences Operator Manual: Helena C-1, Helena C-2, Helena C-4 List of figures Figure 1: Top view – Helena C-1 ......................8 Figure 2: Rear view ..........................8 Figure 3: Side view ..........................8 Figure 4: Determination of turning point in clotting method ..............14 Figure 5: System Information .......................

  • Page 7: Introduction

    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.

  • Page 8: Views Of The Device

    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...

  • Page 9: Consumables / Accessories

    Helena Biosciences Operator Manual: Helena C-1, Helena C-2, Helena C-4 CONSUMABLES / ACCESSORIES Helena C-Series products available Product Description C-1X Helena C-1 1 x single channel semi-automated coagulation analyser with starter kit. C-2X Helena C-2 1 x two channel semi-automated coagulation analyser with starter kit.

  • Page 10: Intended Use

    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.
  • Page 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 Reagent Barcode Input LOT + Expiry...

  • Page 12: Test Methods

    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 anti- coagulation drugs like Heparin or Warfarin.

  • Page 13: Measurement Principle

    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.

  • Page 14: Clotting Method (Pt, Aptt

    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.

  • Page 15: Safety Information

    1.5.2 SAFETY INFORMATION FOR MATERIALS Use only Helena Biosciences Europe approved and labelled material like cuvettes, spare parts or reagents for which the instrument is intended and validated for.

  • Page 16: Safety Information Regarding Risk Of Health

    Helena Biosciences Operator Manual: Helena C-1, Helena C-2, Helena C-4 1.5.3 SAFETY INFORMATION REGARDING RISK OF HEALTH Bleeding or Thrombosis Diagnosis and medication of the human coagulation system based on false results may lead to critical bleeding or thrombosis. For risk reduction it is essential to follow the suggestions below.

  • Page 17: Safety Information For Cleaning, Maintenance And Servicing

    Helena Biosciences Operator Manual: Helena C-1, Helena C-2, Helena C-4 1.5.4 SAFETY INFORMATION FOR CLEANING, MAINTENANCE AND SERVICING Authorized service only! Carry out only the measures listed in this operator’s manual for maintenance, repair and replacement. Improper manipulation of the device will void the manufacturer's liability obligations and may make service calls necessary, including payments which are not covered by warranty.

  • Page 18: Electrical Safety

    The instrument must be recycled as required by guideline WEEE (2012/19/EU). As of the 19 February 2007, Helena Biosciences Europe products meet the European Union Waste Electrical and Electronic Equipment (WEEE) Directive. When supplied as B2B EEE the producer invokes regulation 12.2 and passes all WEEE obligations to the end user.

  • Page 19: Installation Of The Helena C-Series

    Helena Biosciences Operator Manual: Helena C-1, Helena C-2, Helena C-4 INSTALLATION OF THE HELENA C-SERIES SCOPE OF DELIVERY Contents of standard delivery package for Helena C-1, Helena C-2 and Helena C-4: Contents Helena C-Series Instrument Power Supply Cable with EU, UK & US adaptors Single Cuvettes (x100) Reagent Containers, Ø22.5 mm (x5)

  • Page 20: Conditions Of Operation

    Helena Biosciences Operator Manual: Helena C-1, Helena C-2, Helena C-4 CONDITIONS OF OPERATION Ambient conditions: Operating Temperature 15 to 30 °C Humidity < 70% rel. humidity Elevation above NN sea level < 3,000m Free of dust Grade 2 Impact resistance According to IEC/EN 61010-1, 8.2.2...

  • Page 21: First Installation

    Helena Biosciences Operator Manual: Helena C-1, Helena C-2, Helena C-4 FIRST INSTALLATION Inspect the packaging of the Helena C-Series instrument and accessories for any visible external damage. If the packaging is damaged, contact the transport company so that any damage to the device or accessories can be assessed.

  • Page 22: Switching On And Off

    Helena Biosciences Operator Manual: Helena C-1, Helena C-2, Helena C-4 SWITCHING ON AND OFF Switching on Connect with power supply Important Information: The instrument requires approximately 15 minutes to heat up the optic block to 37°C. Afterwards it is ready for measurement, indicated by a green dot in the top right corner of the display.

  • Page 23: Display Protection Foil

    Helena Biosciences Operator Manual: Helena C-1, Helena C-2, Helena C-4 DISPLAY PROTECTION FOIL Requirements: Type: Touch sensitive Protection foil, Ready to fix on display. Size: Same as Display (4,3”) Installation:  Clean the display before attaching the protector foil. Removing any dirt or dust particles, first with a clean wet tissue and then a dry tissue.

  • Page 24: Tecam Smart

    Helena Biosciences Operator Manual: Helena C-1, Helena C-2, Helena C-4 TECAM SMART Requirements: License: TECAM SMART fingerprint and activation code. Cable: USB, type A to B, max 3m Interface: Setting: No handshake or protocol. Barcode must be finished with carriage return.

  • Page 25: Registration

    Helena Biosciences Operator Manual: Helena C-1, Helena C-2, Helena C-4 REGISTRATION The instrument must be registered online for warranty or service issues 1) Visit the C-Series website: www.c-series.com. 2) The site provides help and instructions. Follow the Register link. 3) Enter SIN + PIN of device.

  • Page 26: Operation Of The Helena C-Series

    Helena Biosciences Operator Manual: Helena C-1, Helena C-2, Helena C-4 OPERATION OF THE HELENA C-SERIES HOMESCREEN After boot or home button following screen is displayed FIGURE 7: HOMESCREEN HELENA C-SERIES UI Element Element Name Use Function Date & Time Edit date...

  • Page 27: Input Patient Identification

    Helena Biosciences Operator Manual: Helena C-1, Helena C-2, Helena C-4 INPUT PATIENT IDENTIFICATION Call: Home screen/Optic button FIGURE 8: INPUT PATIENT ID Button UI Element Use Function Numeric keys 0-9, C, X Change or delete PID. Increment PID. Use long touch feature...

  • Page 28: Test Selection

    Helena Biosciences Operator Manual: Helena C-1, Helena C-2, Helena C-4 TEST SELECTION Call: Home screen/Test button FIGURE 9: TEST SELECTION HELENA C-2/C-4. FIGURE 10: TEST SELECTION HELENA C-1. Button UI Element Use Function PT – F12 Select test. Test keys >>...

  • Page 29: Measurement

    Helena Biosciences Operator Manual: Helena C-1, Helena C-2, Helena C-4 MEASUREMENT FIGURE 11: SCREEN DURING MEASUREMENT Button (7) during measurement Patient identification number (max 16 numbers). PT = 12.5s, 115% 0,91 INR. Result f = very low fibrinogen (weak clot).

  • Page 30: System Settings

    Helena Biosciences Operator Manual: Helena C-1, Helena C-2, Helena C-4 SYSTEM SETTINGS Menu and functions depend on instrument version Helena C-1, Helena C-2, Helena C-4. Call: Home screen/Menu button FIGURE 12: QUICKMENU HELENA C-SERIES Button Use Function Auto PID Enable/Disable the Auto PID feature.

  • Page 31: Figure 13: System Settings Helena C-2 And Helena C-4

    Helena Biosciences Operator Manual: Helena C-1, Helena C-2, Helena C-4 Results: Pressing the Results button opens the result history screen. Setup: Pressing the Setup button opens the system settings. Pressing the Sleep Button sends the device into the sleep mode. To wake the device up, touch anywhere on the screen.

  • Page 32: Test Settings

    Helena Biosciences Operator Manual: Helena C-1, Helena C-2, Helena C-4 TEST SETTINGS Call: Home screen / Test button / Settings FIGURE 14: TEST SETTING 1 Setting/Buttons UI Element Use Function LOT Number field Press the LOT text field to enter or change LOT number.

  • Page 33: Figure 15: Test Setting 2

    Helena Biosciences Operator Manual: Helena C-1, Helena C-2, Helena C-4 Incubation: Required waiting time until adding final reagent and start measurement. The time is used for countdown. Stop: Some samples do not clot. After stop time the instrument stops measurement and reports “+++”...

  • Page 34: Review Results

    Helena Biosciences Operator Manual: Helena C-1, Helena C-2, Helena C-4 REVIEW RESULTS The device automatically stores the most recent 100 results into its memory. The most recent result is shown first. If the result history exceeds the memory, then the oldest measurement result is overwritten.

  • Page 35: Ticket System

    Helena Biosciences Operator Manual: Helena C-1, Helena C-2, Helena C-4 TICKET SYSTEM 1) Login to ticket system Visit the general C-Series support site: www.c-series.com Follow the Register link to the cuvette registration page. Enter SIN and PIN of instrument! This information can be found on the instrument license plate (label on underside of instrument), Instrument ID card, or on info screen.

  • Page 36: Figure 20: Ticket System, Input Code

    Helena Biosciences Operator Manual: Helena C-1, Helena C-2, Helena C-4 3) Transfer ticket code to instrument Open info screen (touch blinking RED LED) and then “Remaining tests=0”. The code can be transferred by manual input, barcode scanner or TECAM SMART software.

  • Page 37: Service Functions

    Helena Biosciences Operator Manual: Helena C-1, Helena C-2, Helena C-4 SERVICE FUNCTIONS Only for authorized and trained personnel. Unqualified modifications can cause problems and system errors! SYSTEM INFORMATION Call: Home screen / green or red LED FIGURE 22: SYSTEM INFORMATION...

  • Page 38: Optic Check

    Helena Biosciences Operator Manual: Helena C-1, Helena C-2, Helena C-4 OPTIC CHECK Call: Home screen / green or red LED / Optic FIGURE 23: OPTIC CHECK Button Caption Use Function (1)-(4) OPTIC xx Reset QC value. I=mA Display and change intensity of LED.

  • Page 39: System Report

    Helena Biosciences Operator Manual: Helena C-1, Helena C-2, Helena C-4 SYSTEM REPORT Call: Home screen / green or red LED / Print SYSTEM REPORT 08.10.2019 Date of report System: Helena C-4 name of system Version: Vxx.xx.xx software version SIN :...

  • Page 40: Adjust Temperature

    Helena Biosciences Operator Manual: Helena C-1, Helena C-2, Helena C-4 ADJUST TEMPERATURE Call: Home screen / Menu / Temperature 1. Switch on device and wait approx. 15 minutes until system shows 37°C on screen. 2. Fill a reagent tube/vial with 2 mL water and place it in a reagent position. Place a calibrated digital thermometer in the reagent tube and let it warm-up for approx.

  • Page 41: Overview Of Mainboard

    Helena Biosciences Operator Manual: Helena C-1, Helena C-2, Helena C-4 OVERVIEW OF MAINBOARD FIGURE 24: MAINBOARD Testpin Function: TP1 = Systick Interval, must toggle each 1ms TP2 = indicate reading of SD24 TP3 = draw homescreen TP4 = Write to EEprom...

  • Page 42: Typical Failures

    Helena Biosciences Operator Manual: Helena C-1, Helena C-2, Helena C-4 TYPICAL FAILURES Malfunction / Error Possible cause Measures Open system info and System not ready Multiple. User check red errors. Remaining tests = 0 No cuvette activated. Create a ticket.

  • Page 43: Hidden Functions

    Helena Biosciences Operator Manual: Helena C-1, Helena C-2, Helena C-4 HIDDEN FUNCTIONS RESET TO FACTORY DEFAULT System factory reset procedure: FIGURE 25: WELCOME SCREEN AND FACTORY DEFAULT How to reset to factory default: Press 3sec to spinner during boot up.

  • Page 44: Working With Tecam Smart

    WORKING WITH TECAM SMART This is an overview of TECAM. For additional information about installation and  operation contact Helena Biosciences Europe Haemostasis Technical Support. TechSupport-HS@helena-biosciences.com TECAM software is a small local LIS and combines laboratory data management, quality control and research functions in one.

  • Page 45: Cleaning And Maintenance

    Helena Biosciences Operator Manual: Helena C-1, Helena C-2, Helena C-4 CLEANING AND MAINTENANCE  Clean with a lint free cotton cloth or stick.  Never put any liquid into the optic working area or onto touch display.  Keep the device free of dust and moisture.

  • Page 46: Appendix

    Helena Biosciences Operator Manual: Helena C-1, Helena C-2, Helena C-4 APPENDIX TECHNICAL DATA Analyser Display capacitive touch sensitive TFT 4.3’’ 480x272 Measurement system 1-4 independent measurement channels wavelength of LED 405 nm Cuvette single channel cuvette for optical detection Positions (prewarmed) 5 reagent positions at 36.5 –...

This manual is also suitable for:

C-1C-2C-4

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