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horiba Yumizen G405 User Manual
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horiba Yumizen G405 User Manual

Coagulation analyzer
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Coagulation Analyzer: Yumizen G405
User Manual
Ref: RAB365AEN

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Summary of Contents for horiba Yumizen G405

  • Page 1 Coagulation Analyzer: Yumizen G405 User Manual Ref: RAB365AEN...
  • Page 3 User Manual User Manual Ref: RAB365AEN...
  • Page 5 Contents Foreword ............................3 1. Revisions ............................ 4 2. Legal Information ........................5 Introduction ........................... 9 1. Warning and Precautions ....................10 2. Operational Conditions ...................... 13 3. Labels and Connections ....................17 4. Printer ............................20 Specifications ..........................21 1. Technical Specifications ....................22 2.
  • Page 6 2. Quality Control ........................44 Workflow ............................47 1. Start of Day ..........................48 2. Running Controls ........................49 3. Running Analyses ......................... 52 4. Results Management ......................54 5. End of Day ..........................57 Settings ............................59 1. To Create a New User ......................60 2.
  • Page 7 ............................ 4 2. Legal Information ........................5 2.1. Declaration of Conformity......................5 2.2. Notice of Liability..........................5 2.3. Trademarks............................ 5 2.4. Graphics............................5 2.5. Document Symbols........................6 2.6. Typographical Conventions......................6 2.7. Copyright © 2024 by HORIBA ABX SAS..................7 User Manual Ref: RAB365AEN...
  • Page 8 This document applies to the latest software version listed and higher versions. When a subsequent software version changes the information in this document, a new electronic edition is released and supplied by HORIBA Medical. To update a paper document, please contact your local HORIBA Medical representative. User Manual Ref: RAB365AEN...
  • Page 9 The information in this manual is distributed on an "As Is" basis, without warranty. While every precaution has been taken in the preparation of this manual, HORIBA Medical will not assume any liability to any persons or entities with respect to loss or damage, caused or alleged to be caused...
  • Page 10 Used for windows titles, dialog boxes The Main Menu window is displayed. titles or tabs titles. More information on www.horiba-abx.com/ External links can be used to retrieve documentation. information from a web site. User Manual Ref: RAB365AEN...
  • Page 11 2.7. Copyright © 2024 by HORIBA ABX SAS All rights reserved. No part of this publication may be reproduced or transmitted in any form or by any means, electronic, mechanical, photocopying, recording, or otherwise, without the prior written permission of HORIBA Medical.
  • Page 12 Foreword Legal Information User Manual Ref: RAB365AEN...
  • Page 13 Introduction Contents Introduction 1. Warning and Precautions ....................10 1.1. Limited Warranty.......................... 10 1.2. Safety Precautions........................11 2. Operational Conditions ...................... 13 2.1. Environment..........................13 2.2. Location............................13 2.3. Grounding............................ 13 2.4. Humidity and Temperature Conditions..................14 2.5. Electromagnetic Environment Check...................14 2.6.
  • Page 14 1.1. Limited Warranty Please refer to the terms and conditions expressly agreed by HORIBA Medical for the provision of the Product to know the extent of the warranty. Nevertheless, the Warranties are conditioned on: (i) no repairs, modifications or alterations being made to the Product other than by HORIBA Medical or its authorized representatives;...
  • Page 15 Normal wear and tear is excluded, including any expendable items that comprise part of the Product (such as fuses, light bulbs and lamps). HORIBA Medical does not warrant or guarantee that any Product will be secure from cyber threats, hacking or similar malicious activity. Products that are networked, connected to the internet, or otherwise connected to computers or other devices must be appropriately protected by Buyer and/or end user against unauthorized access.
  • Page 16 Introduction Warning and Precautions All accessible surfaces of the instrument can be potentially contaminated by human specimens. Disposable gloves and lab coat must be worn by the operator. Local and national regulations must be applied in all the operations. The manufacturer uses disinfectant products for instrument decontamination and highly recommends it to decontaminate your instrument.
  • Page 17 Operational Conditions 2.1. Environment The operation of the Yumizen G405 should be restricted to indoor location use only. The instrument is designed for safety from voltage surges according to INSTALLATION CATEGORY II and POLLUTION DEGREE 2 (IEC 61010-1). Please contact your local representative for information regarding operation locations when it does not comply with the recommended specifications.
  • Page 18 Use only the main supply cable and the external power supply delivered with the instrument. If a new main supply cable or a new external power supply is needed, please contact your local HORIBA Medical representative to obtain it. Main power supply voltage fluctuations must not exceed +/- 10% of the nominal voltage.
  • Page 19 Before instrument removal from use, transportation or disposal, perform a general cleaning and a draining of your instrument. 2.9. Installation A representative must install your instrument and software. Package content: ■ Yumizen G405 ■ External power supply ■ User manual ■ Paper rolls for integrated printer ■ Touch screen pen User Manual...
  • Page 20 ■ Magnetic stirrers ■ Adapter for 4 mL vials ■ Cuvettes (500 pcs) Only HORIBA Medical approved materials should be used with the Yumizen G405. 2.10. Package Factory package of the analyzer Yumizen G405 and its implements consists of: ■ corrugated cardboard Package protects analyzer and its implements from adverse factors of outside environment.
  • Page 21 Introduction Labels and Connections Labels and Connections 3.1. Serial Number Label The serial label is located at the back of the instrument. 3.2. Manufacturing Date The manufacturing date is included in the instrument serial number (format: YYYYMMDD). User Manual Ref: RAB365AEN...
  • Page 22 Use only the main supply cable and the external power supply delivered with the instrument. If a new main supply cable or a new external power supply is needed, please contact your local HORIBA Medical representative to obtain it. User Manual...
  • Page 23 Introduction Labels and Connections 3.5. Instrument Peripherals Connections 1 = USB (Keyboard, Mouse, Printer, Barcode reader) 2 = Ethernet connection All peripheral devices should comply with relevant standards. User Manual Ref: RAB365AEN...
  • Page 24 Introduction Printer Printer Use the printer supplied or approved by HORIBA Medical. The Yumizen G405 includes an integrated ticket printer. Contact your local HORIBA Medical representative for more information about printer compatibility and consumable part numbers. User Manual Ref: RAB365AEN...
  • Page 25 Specifications Contents Specifications 1. Technical Specifications ....................22 1.1. Intended Use..........................22 1.2. Analysis Methods......................... 22 1.3. Throughput Analyses........................22 1.4. Reagent............................23 1.5. Sample............................23 1.6. Sample Collection and Mixing..................... 23 1.7. Instrument Characteristics......................24 2. Cybersecurity Description ....................25 2.1. Operating Environment........................ 25 2.2.
  • Page 26 Technical Specifications 1.1. Intended Use The Yumizen G405 is a 4-channel semi-automated blood coagulation analyzer. The instrument can analyze decalcified plasma samples using clotting, chromogenic and immunoturbidimetric methods. The analyzed data can be stored, displayed and reported. The instrument has several functions, including built-in thermal printer and connectivity to use automatic reagent handling by barcode system.
  • Page 27 Specifications Technical Specifications Instrument Throughput Unit - Test Yumizen G405 PT/hr 1.4. Reagent Vial Accepted ■ 30 mm outer diameter vials ■ 22 mm outer diameter vials (with adaptor) Reagents Management ■ Manual reagent identification ■ Barcode reagent identification (optional) Sampling ■...
  • Page 28 Use established good laboratory working practice when collecting specimens. Otherwise, patient results may be impacted. For additional information on collecting venous blood samples, refer to CLSI document H21-A5 and HORIBA Medical Hemostasis Preanalytical Guidelines available online at https://www.horiba.com/int/medical/. Consider all specimens, reagents, calibrators, controls, etc. that contain human specimen extracts as potentially infectious! Use established, good laboratory working practices when handling specimens.
  • Page 29 Cybersecurity Description Cybersecurity Description For additional information about specifications for software, hardware, network characteristics, and security controls refer to the cybersecurity whitepaper. For more detailed information, please contact your local HORIBA Medical representative. 2.1. Operating Environment 2.1.1. Hardware Configuration ■ Color LCD touch screen: 15.5 x 8.5 cm 2.1.2.
  • Page 30 Specifications Cybersecurity Description 2.4. User Access Control Mechanism Number of account types: 3 The user and the laboratory manager cannot modify the setup and calibration passwords. Only the technician can modify them. User account Method of identifying users Access rights 2 - Service Specific Technician password to type when Everything...
  • Page 31 Use only the main supply cable and the external power supply delivered with the instrument. If a new main supply cable or a new external power supply is needed, please contact your local HORIBA Medical representative to obtain it. ■ Maximum input voltage range: from 100 V to 240 V (+/- 10%), 50 Hz to 60 Hz ■...
  • Page 32 Specifications Physical Specifications Clinical and Laboratory Standards Institute 1998 Standards for Water: Type I Bacteria (CFU/mL) <10 Resistivity (megaohm-cm at 25°C (77°F)) >10 (must be measured in-line) SiO2 mg/L <0.05 Total Solids mg/L Total Oxidizable Organic Carbon mg/L <0.05 It is common practice for laboratories to use local distilled water. However the growth of bacterial elements interferes in hemostasis.
  • Page 33 These reagents are used for in vitro diagnostic. All these reagents are manufactured by HORIBA ABX SAS. Refer to the reagent notices and material safety data sheets for Yumizen G405 available online at www.horiba-abx.com/documentation. The reagents specified for this instrument have been approved in accordance with the applicable in vitro medical devices European legislation in force.
  • Page 34 Specifications Reagents Specifications 4.3. Waste Handling Precautions The specimens, reagents, calibrators, controls, etc. and waste liquids that contain human specimen extracts are potentially infectious; all accessible surfaces of the instrument can be potentially contaminated by human specimens. Protective clothing must be worn (lab coat, gloves, eye protection, etc.). Follow your local and/or national guidelines for biohazard waste disposal.
  • Page 35 Specifications Cuvettes Specifications Cuvettes Specifications 5.1. Intended Use Yumizen G Cuvettes are single use cuvettes for Yumizen G Line semi-automated and fully automated coagulation analyzers. For in vitro diagnostic use only. 5.2. Cuvettes Reference Designation Reference Yumizen G Cuvettes 1300036425 User Manual Ref: RAB365AEN...
  • Page 36 In the Maintenance and Troubleshooting section, specific maintenance procedures are listed. The maintenance procedures identified are mandatory for proper use and operation of the Yumizen G405. Failure to execute any of these recommended procedures may result in poor reliability of the system.
  • Page 37 Software Contents Software 1. Software Overview ....................... 34 2. Software Buttons Description ..................35 3. Menus Description ....................... 37 4. Status During Analysis ....................... 38 User Manual Ref: RAB365AEN...
  • Page 38 Software Overview Software Overview The Yumizen G405 includes a software that allows you to navigate in the various screens. The touch screen allows easy and direct access to all functions via buttons. A = The information bar displays temperature date, time and functionalities related to the screen currently displayed.
  • Page 39 Software Software Buttons Description Software Buttons Description Main Screen Buttons Measure Allows you to perform a measurement. Results Allows you to access the results and the archived results. Catalogue Allows you to type reagents, calibrators and controls. Allows you to perform quality controls. Test Setup Allows you to configure tests.
  • Page 40 Software Software Buttons Description Back Allows you to go back to the previous screen. Print Allows you to print elements. Filter Allows you to set a filter. Select Allows you to select results. Archive Allows you to check the archived results. Curve Allows you to display the curve of the result.
  • Page 41 Software Menus Description Menus Description 0 - Assistant 1 - Labor Manager 2 - Service 1 - Labor Manager 2 - Service Sample measurement Measure Quick Setup Control Measurement Catalogue Test Setup Results Hardware Calibration System System Menu Info Management User Manual Ref: RAB365AEN...
  • Page 42 Software Status During Analysis Status During Analysis In addition to the steps to follow displayed on the screen, a LED gives information about the status during the analysis. Step Time counter LED color Add cuvette Add sample Add reagent 1 Add reagent 2 Add reagent 3 Add reagent 4...
  • Page 43 Quality Assurance Contents Quality Assurance 1. Calibration ..........................40 1.1. Adding Reagents and Calibrators to the Catalogue with a Barcode Reader......40 1.2. Adding Reagents and Calibrators to the Catalogue Manually.............41 1.3. To Modify the Mean Normal Value....................42 2. Quality Control ........................
  • Page 44 Quality Assurance Calibration Calibration 1.1. Adding Reagents and Calibrators to the Catalogue with a Barcode Reader 1.1.1. To Add a Reagent to the Catalogue with a Barcode Reader Access: Main Menu > Catalogue You need: ■ a barcode reader ■ target values sheets 1.
  • Page 45 Quality Assurance Calibration 2. In the Type selector field, select Calibrator. 3. Scan your vial with your barcode reader. 4. Press Value sheet. 5. Scan each line, one after another. 6. Press Apply. 7. Press Save. 1.2. Adding Reagents and Calibrators to the Catalogue Manually 1.2.1.
  • Page 46 Quality Assurance Calibration 1.2.2. To Add a Calibrator to the Catalogue Manually Access: Main Menu > Catalogue You need: ■ a barcode reader ■ target values sheets 1. Press Add. 2. In the Type selector field, select Calibrator. 3. Type the following information: ■...
  • Page 47 Quality Assurance Calibration 3. In the Unit field, select the unit according to your test: Tests Units APTT Ratio Ratio 4. Type your new MNAPTT, MNTT or MNPT and press Save. 5. For PT also press %. 6. Readjust the calibration curve (Thivolle) points with the new MNPT. Keep the same difference between the values following the example below where the new calculated MNPT is 13.5.
  • Page 48 Quality Assurance Quality Control Quality Control Quality Control allows the user to monitor a set of analyses based on known sample values and ranges over a period of several months. Statistical computations performed on these populations allow the extraction of qualitative information related to the stability of the instrument. 2.1.
  • Page 49 Quality Assurance Quality Control 1. Press Add. 2. In the Type selector field, select Control. 3. Type the following information: ■ Name ■ Lot ■ RefNum ■ Volume ■ Expire 4. Press Value sheet. 5. Type each line, one after another. 6.
  • Page 50 Quality Assurance Quality Control User Manual Ref: RAB365AEN...
  • Page 51 Workflow Contents Workflow 1. Start of Day ..........................48 1.1. To Switch the Instrument On....................... 48 1.2. To Log in to the Instrument......................48 2. Running Controls ........................49 2.1. To Run a Quality Control......................49 2.2. To Check Control Results......................50 2.3.
  • Page 52 Workflow Start of Day Start of Day 1.1. To Switch the Instrument On Before switching the instrument on, you need to check the operational conditions described in the Introduction > Operational Conditions chapter. If you use a barcode reader, connect it to the instrument before switching the instrument on. 1.
  • Page 53 Workflow Running Controls Running Controls 2.1. To Run a Quality Control Access: Main Menu > Measure You have entered your quality control information in the Catalogue menu. You need: ■ your reagent ■ cuvettes 1. Select your test in the list. 2.
  • Page 54 If results are still out of range, please check your control or reagent stability and handling. Also check calibration setup according to the reagent type and lot used. If the problem persists, please contact your local HORIBA Medical representative. User Manual...
  • Page 55 Workflow Running Controls 2.3. To Change the Ranges Access: Main Menu > QC You have previously run a control. 1. In the list on the left, select the test. 2. Press Change range. 3. Type the new values. 4. Press Save. User Manual Ref: RAB365AEN...
  • Page 56 Workflow Running Analyses Running Analyses In case of sample manual pre-dilution with a dilution factor different than HORIBA Medical recommendations (see Reagent Quick Step Guide), the pre-dilution ratio must be considered in the reported result. 3.1. To Run an Analysis Access: Main Menu >...
  • Page 57 Workflow Running Analyses 7. Press the reagent you need to use. 8. Follow the instructions on screen during measurement. The different steps are indicated thanks to different colors and beeps. User Manual Ref: RAB365AEN...
  • Page 58 Workflow Results Management Results Management 4.1. To Sort Results Access: Main Menu > Results You can sort the result by sample ID and by date. 1. Press Filter. 2. If you need to search with the sample ID: a. Press SmpID b.
  • Page 59 Workflow Results Management 3. Press Print. 4. Press Yes. The result is printed on the ticket. 4.3. To Send Results to the LIS Access: Main Menu > Results LIS connection must be configured. 1. If you need to send one result, select the result. 2.
  • Page 60 Workflow Results Management 4.4. To Archive Results Access: Main Menu > Results 1. If you need to archive one result, select the result. 2. If you need to archive several results: a. Press Select. b. Press Multiselect. c. Select the results by pressing the gray part of the rows on the left. 3.
  • Page 61 Workflow End of Day End of Day 5.1. To Logout Press Logout. 5.2. To Switch the Instrument Off After a day of work, perform the following actions: 1. Switch the instrument off. 2. Decontaminate the instrument. Refer to the Maintenance and Troubleshooting > Maintenance Procedures > To Decontaminate the Instrument Externally chapter.
  • Page 62 Workflow End of Day User Manual Ref: RAB365AEN...
  • Page 63 Settings Contents Settings 1. To Create a New User ......................60 2. To Enable or Disable a User .....................61 3. To Change the Date and Time ..................62 User Manual Ref: RAB365AEN...
  • Page 64 Settings To Create a New User To Create a New User Access: Main Menu > System Menu > System > Manage user > Add users To perform this procedure, you need an account with the following rights: 1 - Labor Manager. 1.
  • Page 65 Settings To Enable or Disable a User To Enable or Disable a User Access: Main Menu > System Menu > System > Manage user > Add users To perform this procedure, you need an account with the following rights: 1 - Labor Manager. 1.
  • Page 66 Settings To Change the Date and Time To Change the Date and Time Access: Main Menu > System Menu > System > Date/Time To perform this procedure, you need an account with the following rights: 1 - Labor Manager. 1. Change the time and date according your timezone. 2.
  • Page 67 Description and Technology Contents Description and Technology 1. Instrument Description .......................64 1.1. Front Side.............................64 1.2. Rear Side............................64 2. Measurement Principles ....................65 2.1. General Description........................65 2.2. Nephelometry..........................65 2.3. Turbidimetry..........................67 2.4. Colorimetry...........................68 2.5. Clot Waveform Analysis (CWA) (Post Check)................69 User Manual Ref: RAB365AEN...
  • Page 68 Description and Technology Instrument Description Instrument Description 1.1. Front Side A = Printer cover B = Printer cover opening button C = Touchscreen D = Incubation positions E = Reagent incubation positions F = Measuring channels G = LED indicator 1.2.
  • Page 69 Description and Technology Measurement Principles Measurement Principles 2.1. General Description The Yumizen G405 instrument is a 4 channels optical coagulometer. 2.1.1. Measurement Details Reaction method Clotting Immunological Chromogenic Measurement method Nephelometry Turbidimetry Colorimetry Measurement type Scattered light Absorbance Absorbance Calculation mode...
  • Page 70 Description and Technology Measurement Principles 2.2.2. Nephelometry Graph Description During the clot formation, the scattered light intensity increases and the kinetic curve can be obtained. The instrument measures the light intensity at 640 nm. A = End of reagent dispensing B = Lag time C = Minimum time D = Coagulation time...
  • Page 71 Description and Technology Measurement Principles Correlation between the histogram and the reaction curve 2.3. Turbidimetry 2.3.1. Turbidimetry Measurement Principle The turbidimetry is based on the measurement of the lost intensity due to the light absorption. 570 nm Measuring block Cuvette Sample Reagent Detector...
  • Page 72 Description and Technology Measurement Principles Calibration curve The D-Dimer calibration is obtained by a successive calibrator points with different concentrations. 2.4. Colorimetry 2.4.1. Colorimetry Measurement Principle The colorimetry is based on the measurement of the light intensity passing through the colored reaction.
  • Page 73 Description and Technology Measurement Principles 2.4.2. Colorimetry Graph Description Measurement curve ΔOD / min = linear regression between OD , OD and T End time First time Measuring time Example of calibration curve The AT calibration is obtained by successive dilutions of the calibrator. 2.5.
  • Page 74 Description and Technology Measurement Principles There is no coagulation. The coagulation is too weak. Measured curve data is superior to maximum value. User Manual Ref: RAB365AEN...
  • Page 75 Description and Technology Measurement Principles The maximum value depends on the test. An air bubble creates a discontinuous curve. The instrument measures the last plateau (end of reaction) for at least a minimum time. If a plateau is detected before the defined minimum recording time, the instrument does not take it into account.
  • Page 76 Description and Technology Measurement Principles User Manual Ref: RAB365AEN...
  • Page 77 Maintenance and Troubleshooting Contents Maintenance and Troubleshooting 1. Maintenance Procedures ....................74 1.1. To Decontaminate the Instrument Externally................74 2. Troubleshooting Procedures ................... 76 2.1. To Change the Printing Paper......................76 2.2. Instrument Error Messages......................76 2.3. To Check the Instrument......................77 User Manual Ref: RAB365AEN...
  • Page 78 ■ Active on Aspergillus fumigatus ■ Active on Mycobacterium tuberculosis (BK) ■ Antiviral (HIV, HBV and rotavirus) Product example recommended by HORIBA Medical: ANIOS detergent disinfectant; Wip’Anios. See also the WHO (World Health Organization) guidelines: "Laboratory Biosafety Manual, 4th edition" for more information.
  • Page 79 Maintenance and Troubleshooting Maintenance Procedures After cleaning and before starting new analyses, the measuring channels must dry for at least ten minutes at 37°C +/-0.5. User Manual Ref: RAB365AEN...
  • Page 80 For technical assistance, you can call +33 (0)4 67 14 15 16. If a mechanical or electrical problem is suspected, do not perform inspection of the analyzer by yourself. Contact your HORIBA Medical representative. 2.1. To Change the Printing Paper 1.
  • Page 81 Maintenance and Troubleshooting Troubleshooting Procedures 2.3. To Check the Instrument 1. Connect the power cable at the back of the instrument. 2. Switch the instrument on. 3. Check that the temperature at the top of the screen changes to green (37°C +/-0.5) after a few minutes.
  • Page 82 Maintenance and Troubleshooting Troubleshooting Procedures User Manual Ref: RAB365AEN...