Advertisement

Quick Links

CyStain™ VitalCount reagents
Quality Check Manual
CyStain™ VitalCount | Quality Check with CyView™ 1.8
Doc. No.: 7 QC IFU EN | Rev: 001 | Date: 25-06-2021 | EN | CN 2138

Advertisement

Table of Contents
loading

Summary of Contents for SYSMEX CyStain VitalCount

  • Page 1 CyStain™ VitalCount reagents Quality Check Manual CyStain™ VitalCount | Quality Check with CyView™ 1.8 Doc. No.: 7 QC IFU EN | Rev: 001 | Date: 25-06-2021 | EN | CN 2138...
  • Page 2: Table Of Contents

    Introduction ........................ 4  2.1  About this document ..................4  2.2  About the procedure ..................4  2.3  Installation and alteration ................4  2.4  Sysmex representatives ................. 4  2.5  Authorised distributors .................. 4  3  Overview ........................5  3.1  CyView™ script ....................5  3.2 ...
  • Page 3: Identification

    1 Identification 1 Identification The Quality Check procedure is applicable to: Reagent / Reagent kit Name CyStain™ VitalCount Manufacturer Sysmex Partec GmbH 05-5029 Device Name CyFlow™ Cube 6 V2m Software CyView™ 1.8 and above Manufacturer Sysmex Partec GmbH CY-S-3061R-V2m CyStain™ VitalCount QC Procedure | QC Manual | June 2021...
  • Page 4: Introduction

    VitalCount reagent kits with a CyFlow™ Cube 6 V2m. Emphasis is placed on execution and troubleshooting. Please refer to the CyFlow™ Cube 6 V2m manual for correct and safe use of the device. For questions about this manual or the use of the device, please contact your local Sysmex representative. 2.2 About the procedure The Quality Check scripts simplify and automate the QC procedure of the CyFlow™...
  • Page 5: Overview

    3 Overview 3 Overview 3.1 CyView™ script The Quality Check procedure is integrated into a CyView™ configuration file (*.cvc85) - called a CyView™ script. To access the QC procedure, the “QC”-Mode within the respective CyView™ script can be activated. 3.2 FCS Express™ template FCS Express™...
  • Page 6: Qc Material Lot Dependency

    3 Overview QC material LOT dependency The CyView™ script as well as the FCS Express™ templates are designed for a specific Count Check Beads green (05-4011_R) LOT. Check before QC procedures LOT of used Count Check Beads green and revision of the script / templates are matching (see 4.2 Quality Check procedure).
  • Page 7: Operation

    4 Operation 4 Operation 4.1 Software CyView™ is used for control of the device, data acquisition, data analysis and storage. For more information, please refer to the CyFlow™ Cube 6 V2m manual. FCS Express™ is used for reporting and analysis of data. The software can be accessed directly from within CyView™.
  • Page 8: Running A Quality Check

    4 Operation 6. Click [Stop]. 7. Connect the Sample tube with 1500 μl Sheath Fluid. Figure 8: Intermediate Cleaning 8. Activate [Intermediate Cleaning]. 9. Switch Measure Mode (Sample Source) back to “Autoloader”. 10. Switch Measure Mode (Sample Volume) to “51 – 100 µl”. 11.
  • Page 9 4 Operation Procedure Figure 9:Selecting QC Robby Mode 1. Select [QC Robby Mode]. 2. Press [Start] and follow the instructions. 3. The CyView™ Robby Autoloader AddOn will open. Assign a new Tray ID, e.g. “QCyyyymmdd”. Figure 10:CyView AddOn 4. Click [Start with new Tray]. 5.
  • Page 10 4 Operation 7. Press [Start] again to run QC Robby. Figure 12:CyView Start Robby 8. Follow the instructions and Click [Continue] to start FCS Express. NOTICE Adjusting Device Settings during a Quality Check Signals should be visible in all dotplots. The predefined QC regions indicate the position where the signals of the beads are expected.
  • Page 11: Analysing The Quality Check With Fcs Express

    4 Operation 4.2.3 Analysing the Quality Check with FCS Express™ FCS Express™ opens automatically, once the QC procedure has finished. The QC results will be analysed automatically by FCS Express™. The first 4 digits of the LOT number need to be entered (e.g. “AK01”) in the first part of the LOT N°...
  • Page 12: Measurement Procedure

    4 Operation Procedure 1. Switch to FCS Express™. Data have been transferred automatically to a predefined Layout. 2. Enter Quality Check material information for LOT N , expiry date and reference concentration for Count Check Beads green. 3. The QC results are analysed automatically. Every test performed will “Pass” or “Fail” and a summary will be displayed.
  • Page 13: Troubleshooting

    5 Troubleshooting Fault, cause and remedy If the fault you are experiencing is not described or the remedy could not solve your problem, please contact your local Sysmex representative. NOTICE User Privileges Options for troubleshooting depend on the user privileges. Controls for lasers, gain, flow rate and trigger parameter are only available at Main User level or above.
  • Page 14: Qc Procedure

    5 Troubleshooting Fault Remedy The device emits an unusual Check that the Waste bottle is closed properly and that the / noisy sound after starting bottle is not cracked. the measurement Check all visible tubing and make sure that they are not pinched.
  • Page 15 5 Troubleshooting Fault Remedy Unusal large CV values Perform a priming procedure. and/or failling Optical Perform a cleaning procedure. Alignment test within the Quality Check report Check the date of expiry of the QC material. Shake the bottle of the QC material vigorously (e.g. by vortexing) and repeat the measurement.

Table of Contents