CyStain™ VitalCount | Quality Check with CyView™ 1.8 Doc. No.: 7 QC IFU EN | Rev: 001 | Date: 25-06-2021 | EN | CN 2138
CyStain™ VitalCount reagents
Quality Check Manual
Страница 1: ...CyStain VitalCount Quality Check with CyView 1 8 Doc No 7 QC IFU EN Rev 001 Date 25 06 2021 EN CN 2138 CyStain VitalCount reagents Quality Check Manual...
Страница 2: ...stributors 4 3 Overview 5 3 1 CyView script 5 3 2 FCS Express template 5 3 3 Quality Check material 5 3 4 QC material LOT dependency 6 4 Operation 7 4 1 Software 7 4 2 Quality Check procedure 7 4 2 1...
Страница 3: ...21 3 1 Identification The Quality Check procedure is applicable to Reagent Reagent kit Name CyStain VitalCount Manufacturer Sysmex Partec GmbH REF 05 5029 Device Name CyFlow Cube 6 V2m Software CyView...
Страница 4: ...kits For analysis of the results they are combined with associated FCS Express templates that are automatically launched during the QC procedure It is necessary to apply specific Quality Check scripts...
Страница 5: ...C measurements The templates can also be used to analyse data from QC measurements manually The results can be exported 3 3 Quality Check material The QC procedure uses the following material s For fu...
Страница 6: ...ds green LOT was used The Quality Check is designed solely for QC material stated in chapter 3 3 Quality Check material Similar products such as Count Check Beads green REF 05 4011 are not suitable Ma...
Страница 7: ...ileges of Main User level or above Administrator LOT and FCS Express template match see chapter 3 4 QC material LOT dependency CyStain VitalCount configuration is active1 Priming has been performed Sa...
Страница 8: ...nfiguration file containing suitable gain values for all parameters can be saved on the device It is recommended to maintain the default name for the configuration file Continue by running a Quality C...
Страница 9: ...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 Select each with QC material and inse...
Страница 10: ...ice 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 If the beads signals are not w...
Страница 11: ...s such as spaces Figure 13 Exemplary QC report Page 1 2 before Enter Quality Check material information after Enter Quality Check material information Description Description 1 Input field Quality Che...
Страница 12: ...esults switch to the Batch tab within FCS Express and click Run Choose a suitable file folder and assign a data name A PDF report will be generated and saved into the selected folder Results If all te...
Страница 13: ...eck the flow rate settings Check that the Waste bottle is closed properly and that the bottle is not cracked Check all visible tubes and make sure that they are not pinched Make sure that no air bubbl...
Страница 14: ...at no air bubbles are trapped in the Inline Filter of the Sheath Fluid bottle Check threshold Perform a priming procedure Perform a cleaning procedure Refill the Sheath Fluid Sheath Fluid should be re...
Страница 15: ...QC material Perform a priming procedure Perform a cleaning procedure Adjust gain values for all parameters Count Check Beads green measurement is not within 20 range of the LOT specific concentration...
