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horiba Yumizen G400 DDi User Manual
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horiba Yumizen G400 DDi User Manual

Coagulation analyzer
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Coagulation Analyzer: Yumizen G400 DDi
User Manual
Ref: RAB321FEN

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Summary of Contents for horiba Yumizen G400 DDi

  • Page 1 Coagulation Analyzer: Yumizen G400 DDi User Manual Ref: RAB321FEN...
  • Page 3 User Manual User Manual Ref: RAB321FEN...
  • Page 5 Contents Foreword ............................3 1. Document Update ........................4 2. Legal Information ........................5 Introduction ........................... 9 1. Warning and Precautions ....................10 2. Operational Conditions ...................... 14 3. Labels and Connections ....................18 4. Printer ............................21 Specifications ..........................23 1. Technical Specifications ....................24 2.
  • Page 6 2. Quality Control ........................48 Workflow ............................51 1. Start of Day ..........................52 2. Running Controls ........................53 3. Running Analyses ......................... 56 4. Results Management ......................61 5. End of Day ..........................66 Settings ............................67 1. Instrument Configuration ....................68 2.
  • Page 7 1.2. What's New?..........................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 © 2022 by HORIBA ABX SAS..................7 User Manual Ref: RAB321FEN...
  • 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. 1.2. What's New?
  • 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 First Sequence Number window is displayed. titles or tabs titles. More information on External links can be used to retrieve www.horiba-abx.com/documentation. information from a web site. User Manual Ref: RAB321FEN...
  • Page 11 2.7. Copyright © 2022 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: RAB321FEN...
  • Page 13 Introduction 1. Warning and Precautions ....................10 1.1. Limited Warranty.......................... 10 1.2. Safety Precautions........................11 1.3. Graphics and Symbols.........................12 2. Operational Conditions ...................... 14 2.1. Environment..........................14 2.2. Location............................14 2.3. Grounding............................ 14 2.4. Humidity and Temperature Conditions..................15 2.5. Electromagnetic Environment Check...................15 2.6.
  • Page 14 ■ For laboratory use only. ■ User manual must be entirely read, and personnel trained by a HORIBA Medical representative before attempting to operate the instrument. ■ The user always operates with full knowledge and appreciation of instrument warnings and alarms.
  • Page 15 Introduction Warning and Precautions If this instrument has been supplied to you by anyone other than HORIBA Medical or an authorized representative, HORIBA Medical cannot guarantee this product in terms of specification, latest revision and latest documentation. Further information may be obtained from your authorized representative.
  • Page 16 Introduction Warning and Precautions 1.3. Graphics and Symbols Switch off position Switch on position Direct current Manufacturer This product conforms to the EC Directives and In Vitro Diagnostic medical device Regulation named in the Declaration of Conformity Caution, consult accompanying Biological hazard documents Keep dry...
  • Page 17 Introduction Warning and Precautions Content Health Hazard USB connector Warning; Biological hazard This product should be disposed of and recycled at the end of the useful life in accordance with European Directive 2012/19/EU on Waste Electrical and For indoor use only Electronic Equipment (WEEE) and/or European Directive 2006/66/EC on batteries and accumulators.
  • Page 18 Operational Conditions 2.1. Environment The operation of the Yumizen G400 DDi 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 19 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 20 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 G400 DDi ■ External power supply ■ User manual ■ Paper rolls for integrated printer ■ Protective cover User Manual...
  • Page 21 ■ Magnetic stirrers ■ Adapter for 4 mL vials ■ Cuvettes (500 pcs) Only HORIBA Medical approved materials should be used with the Yumizen G400 DDi. 2.10. Package Factory package of the analyzer Yumizen G400 DDi and its implements consists of: ■...
  • Page 22 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: MMYY). User Manual Ref: RAB321FEN...
  • Page 23 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 24 Introduction Labels and Connections 3.5. Instrument Peripherals Connections 1 = Barcode Reader or USB flash drive 2 = Computer 3 = Printer All peripheral devices should comply with relevant standards. User Manual Ref: RAB321FEN...
  • Page 25 Printer Printer Use the printer supplied or approved by HORIBA Medical. The Yumizen G400 DDi includes an integrated ticket printer. Contact your local HORIBA Medical representative for more information about printer compatibility and consumable part numbers. User Manual Ref: RAB321FEN...
  • Page 26 Introduction Printer User Manual Ref: RAB321FEN...
  • Page 27 Specifications 1. Technical Specifications ....................24 1.1. Intended Use..........................24 1.2. Analysis Methods......................... 24 1.3. Throughput Analyses........................24 1.4. Reagent............................24 1.5. Sample............................25 1.6. Sample Collection and Mixing..................... 25 1.7. Instrument Characteristics......................26 2. Cybersecurity Description ....................27 2.1. Operating Environment........................ 27 2.2.
  • Page 28 Technical Specifications 1.1. Intended Use The Yumizen G400 DDi is a 4-channel semi-automated blood coagulation analyzer. The instrument can analyze decalcified plasma samples using coagulation, chromogenic and immunoassay 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 29 Specifications Technical Specifications Reagents Management ■ Manual reagent identification ■ Barcode reagent identification (optional) Sampling ■ Manual sampling using calibrated pipette 1.5. Sample Sample Types ■ 3.2% (109 mmol/L) sodium-citrate anticoagulated plasma in primary tube. ■ 3.2% (109 mmol/L) sodium-citrate, theophylline, adenosine and dipyramidole (CTAD) anticoagulated plasma in primary tube.
  • Page 30 Specifications Technical Specifications When collecting blood specimens, venous blood is recommended, but arterial blood may also be used in extreme cases. Blood collection must be placed in vacuum or atmospheric collection tubes. The sample collection tube has to be filled to the exact quantity of blood indicated on the tube itself.
  • Page 31 Specifications Cybersecurity Description Cybersecurity Description 2.1. Operating Environment 2.1.1. Hardware Configuration ■ Color LCD touch screen: 11.5 x 8.6 cm 2.1.2. Software Environment Operating System: Not applicable. 2.1.3. Network Condition RS232 connection 2.2. Security Software Not applicable. 2.3. Data and Equipment Interface ■...
  • Page 32 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 Technician Specific Technician password to type when Everything...
  • Page 33 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 34 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 35 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 G400 DDi 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 36 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 37 Specifications Cuvettes Specifications Cuvettes Specifications 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. Cuvettes Reference Yumizen G Cuvettes (1300036425) User Manual Ref: RAB321FEN...
  • Page 38 Limitations Limitations While every effort is taken by HORIBA Medical to investigate and indicate all known interferences, it is not possible to guarantee that all interferences have been identified. At all times, results should be validated and communicated only once all information relating to the patient have been assessed and taken into account.
  • Page 39 Software 1. Software Overview ....................... 36 2. Menus Description ....................... 37 3. Software Buttons Description ..................38 4. Status During Analysis ....................... 39 User Manual Ref: RAB321FEN...
  • Page 40 Software Software Overview Software Overview The Yumizen G400 DDi 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, which displays temperature, date, time and functionalities related to the screen currently displayed.
  • Page 41 D-dimer Protein C ATIII Chromogenic Plasminogen Nephelometric Measure Turbidimetric Result User Defined Tests Chromogenic Settings Results Access Rights: User Language Manager and Service* * Reserved to Horiba Medical Technical Date/time representative System Settings Measure Error messages User Manual Ref: RAB321FEN...
  • Page 42 Software Software Buttons Description Software Buttons Description Filter: allows you to apply filters in the results list. Mark: allows you to select several results. Details: displays the details of a result. Action: allows you to print results, export results on a USB flash drive or delete results. Print: allows you to print the current displayed results in the Result menu.
  • Page 43 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 Ready for testing Green Continuous green Add cuvette to sample area Green Blinking green Add sample...
  • Page 44 Software Status During Analysis User Manual Ref: RAB321FEN...
  • Page 45 Quality Assurance 1. Calibration ..........................42 1.1. Adding Reagents and Calibration Manually.................42 1.2. To Add Reagents and Calibration Automatically................. 45 1.3. To Modify the Mean Normal Value....................46 2. Quality Control ........................48 2.1. Managing Controls........................48 User Manual Ref: RAB321FEN...
  • Page 46 Quality Assurance Calibration Calibration Related information: ■ To Run a Control, p.53 1.1. Adding Reagents and Calibration Manually Access: Main Menu > Calibration If you are not equipped with a barcode reader, perform the following procedure. If you are equipped with a barcode reader, you can add reagents and calibration automatically.
  • Page 47 Quality Assurance Calibration 2. Press the test to calibrate. 3. Press Reagent. 4. Press one of the Reagent slot available. 5. Type the User code and press OK. 6. Type the following information: a. Type the Reagent name and press OK. b.
  • Page 48 Quality Assurance Calibration 4. Press OK. 1.1.2.3. To Add the MNTT Access: Main Menu > Calibration > Screening tests > TT 1. Press Ratio. 2. Press Normal Value. 3. Type the MNTT indicated on the targets sheet. 4. Press OK. 1.1.3.
  • Page 49 Quality Assurance Calibration 2. Press the appropriate unit button: Tests Units Fibrinogen µg FEU/ml D-Dimer ATIII 3. Select the curve type as follows (User code is required): Tests Curve types Lin-Inv Fibrinogen and Factors Log-Log Lin-Lin p-p ATIII and D-Dimer It is possible to see the calibration curve pressing Graph.
  • Page 50 Quality Assurance Calibration To modify the mean normal value refer to the Quality Assurance > Calibration > To Modify the Mean Normal Value chapter. Related information: ■ Adding Reagents and Calibration Manually, p.42 ■ To Modify the Curve Type, p.44 1.3.
  • Page 51 Quality Assurance Calibration PT % Target sheet values (in seconds) New value 13.1 13.5 17.8 18.2 22.7 23.1 27.2 27.6 Related information: ■ To Configure Tests Parameters, p.69 User Manual Ref: RAB321FEN...
  • Page 52 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 53 Quality Assurance Quality Control 3. Type the name of the QC and press OK. 4. Type the Lot code and press OK. 5. Type the Year and press OK. 6. Type the Month and press OK. 7. Press Test: a. Press Name several times to find the name of the test to add. b.
  • Page 54 Quality Assurance Quality Control User Manual Ref: RAB321FEN...
  • Page 55 Workflow 1. Start of Day ..........................52 1.1. To Switch the Instrument On....................... 52 1.2. To Switch the Printer On......................52 2. Running Controls ........................53 2.1. To Run a Control.......................... 53 2.2. To Check Control Results......................54 3. Running Analyses .........................
  • Page 56 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 57 Workflow Running Controls Running Controls 2.1. To Run a Control Access: Main Menu > QC > Measure Reagents must be added in the instrument when a new reagent lot is used. Reagents and controls must be added in the instrument before running controls. To add reagents refer to the Quality Assurance >...
  • Page 58 Workflow Running Controls 5. Follow the instructions on the screen. 6. If you need to go to the previous analysis step or skip one step, press the corresponding measurement window. Two buttons appear. 7. Press Back or Next to change step. The results are stored in Main Menu >...
  • Page 59 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 60 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 61 Workflow Running Analyses 4. Press the upper part of the measurement window (white frame). 5. Type the sample ID and press OK. Measuring channels able to perform the current measurement are indicated with a green LED. 6. Follow the instructions on the screen. 7.
  • Page 62 Workflow Running Analyses 3.2. To Run an Analysis in Quick Mode Access: Main Menu > Measure The Quick mode must be activated. To activate the Quick mode go to Main Menu > System > Measure > Speed > Quick. Before running samples, the following conditions must be fulfilled: ■...
  • Page 63 Workflow Running Analyses 4. Press the upper part of the measurement window (white frame). 5. Type the sample ID and press OK. Measuring channels able to perform the current measurement are indicated with a green LED. 6. Follow the instructions on the screen. 7.
  • Page 64 Workflow Running Analyses 10. When the measurement of samples in the measuring channels ends, remove the samples. 11. When incubation has ended for the next samples located in the incubation area, place them in the measuring channels. The measurement starts for these samples. 12.
  • Page 65 Workflow Results Management Results Management 4.1. To Sort Results Access: Main Menu > Result You can sort results according to the following criteria: test, sample ID and date. 1. Press the Filter button. 2. To filter by test, press Test several times to find the name of the required test. 3.
  • Page 66 Workflow Results Management A dot displays next to the results you selected. 2. Press the Action button. 3. Press one of the following options: ■ Current ■ Marked ■ All ■ Not Printed 4. Press Print. 5. Press the Validate button. Related information: ■...
  • Page 67 Workflow Results Management 3. Press the Print button. Related information: ■ Instrument Configuration, p.68 4.3. To Send Results to the LIS Access: Main Menu > Result LIS connection must be configured. You can choose to export the current result, several results, all of them or those which have not been printed yet.
  • Page 68 Workflow Results Management 2. For several results, use the arrows and press the Mark button to select them. If not, go to next step. A dot displays next to the results you selected. 3. Press the Action button. 4. Press one of the following options: ■...
  • Page 69 Workflow Results Management 1. For several results, use the arrows and press the Mark button to select them. If not, go to next step. A dot displays next to the results you selected. 2. Press the Action button. 3. Press one of the following options: ■...
  • Page 70 Workflow End of Day End of Day 5.1. To Switch the Instrument Off After a day of work, perform the following actions: 1. Switch the instrument off. 2. Remove all the cuvettes. 3. Decontaminate the instrument. Refer to the Maintenance and Troubleshooting > Maintenance Procedures > To Decontaminate the Instrument Externally chapter.
  • Page 71 Settings 1. Instrument Configuration ....................68 2. To Configure Tests Parameters ..................69 User Manual Ref: RAB321FEN...
  • Page 72 Settings Instrument Configuration Instrument Configuration Setting Access menu Action Sound Main Menu > System > Settings Allows you to increase and reduce the volume, or to deactivate it. Printer Main Menu > System > Settings Allows you to activate and deactivate the printer.
  • Page 73 If you use the reagent Yumizen G PT Reco, you must also change the minimum time and lag time from this menu. HORIBA Medical recommends the activation of the parallel mode for result quality improvement. This mode allows you to perform duplicate measurement for a same sample and check the repeatability.
  • Page 74 Settings To Configure Tests Parameters b. Press the Edit button. c. Select the dimensions you want. d. Press OK. 8. To configure the parallel mode: a. Select Parallel with the arrow buttons. b. Press the Edit button. c. Press Parallel to activate the mode. d.
  • Page 75 Description and Technology 1. Instrument Description .......................72 1.1. Front Side.............................72 1.2. Rear Side............................72 2. Measurement Principles ....................73 2.1. General Description........................73 2.2. Nephelometry..........................73 2.3. Turbidimetry..........................75 2.4. Colorimetry...........................77 User Manual Ref: RAB321FEN...
  • Page 76 Description and Technology Instrument Description Instrument Description 1.1. Front Side A = Printer cover B = Printer cover opening button C = USB Type-A D = Touchscreen E = Incubation positions F = Reagent incubation positions G = Measuring channels H = LED indicator 1.2.
  • Page 77 Description and Technology Measurement Principles Measurement Principles 2.1. General Description The Yumizen G400 DDi 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...
  • Page 78 Description and Technology Measurement Principles 2.2.2. Nephelometry Graph Description During the clot formation, the scattered light intensity increases and a sigmoid-like 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 79 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 80 Description and Technology Measurement Principles 2.3.2. Turbidimetry Graph Description Measurement curve The instrument measures the optical density at 570 nm. A = End of reagent dispensing B = First time C = End time ΔOD = OD - OD End time First time Calibration curve The D-Dimer calibration is obtained by a successive calibrator points with different concentrations.
  • Page 81 Description and Technology Measurement Principles 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. 405 nm Measuring block Cuvette Sample Reagent Detector User Manual Ref: RAB321FEN...
  • Page 82 Description and Technology Measurement Principles 2.4.2. Colorimetry Graph Description Measurement curve The instrument measures the kinetic of the reaction at 405 nm. A = End of reagent dispensing B = First time C = End time D = Measuring time ΔOD / min = linear regression between OD , OD and T...
  • Page 83 Maintenance and Troubleshooting 1. Maintenance Procedures ....................80 1.1. To Decontaminate the Instrument Externally................80 2. Troubleshooting Procedures ................... 81 2.1. To Change the Printing Paper......................81 2.2. Instrument Error Messages......................81 2.3. To Check the Instrument......................82 User Manual Ref: RAB321FEN...
  • Page 84 ■ 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, 3rd edition" for more information.
  • Page 85 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 86 Incub. was overheated: The measuring block Rerun analysis or contact your is too hot or if you forgot to add reagent. local HORIBA Medical representative. Expired lot: The reagent used has expired. Enter a new lot. Barcode type error: The reagent type has Check the correct lot number.
  • Page 87 Index Analysis Instrument Method, 24 Characteristics, 26 Quick mode, 58 Configuration, 68 Run, 56 Switch on, 52 Interferences, 34 Calibration Manual creation, 42 Master curve automatic creation, 45 Send result, 63 Changing printing paper Troubleshooting, 81 Check Mean normal value, 46 Control result, 54 Measurement principle Colorimetry...
  • Page 88 Send to the LIS, 63 Sort, 61 Analysis, 56 Control, 53 Sample Identification, 25 Volume, 25 Setting Instrument, 68 Test parameter, 69 Software Buttons description, 38 Overview, 36 Switch on Instrument, 52 Printer, 52 Test Configuration, 69 Troubleshooting Changing printing paper, 81 Turbidimetry Graph description, 76 Measurement principle, 75...
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