SYSMEX CyStain VitalCount User manual
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
Table of contents
2 CyStain™ VitalCount QC Procedure | QC Manual | June 2021
Table of contents
1Identification ..............................................................................................................3
2Introduction................................................................................................................4
2.1About this document......................................................................................4
2.2About the procedure.......................................................................................4
2.3Installation and alteration ..............................................................................4
2.4Sysmex representatives.................................................................................4
2.5Authorised distributors..................................................................................4
3Overview.....................................................................................................................5
3.1CyView™script...............................................................................................5
3.2FCS Express™ template ................................................................................5
3.3Quality Check material ...................................................................................5
3.4QC material LOT dependency........................................................................6
4Operation....................................................................................................................7
4.1Software...........................................................................................................7
4.2Quality Check procedure ...............................................................................7
4.2.1Setting up the Quality Check ............................................................................ 7
4.2.2Running a Quality Check .................................................................................. 8
4.2.3Analysing the Quality Check with FCS Express™.......................................... 11
4.3Measurement procedure ..............................................................................12
5Troubleshooting ......................................................................................................13
5.1Fault, cause and remedy..............................................................................13
5.1.1Sheath Fluid, waste and fluids ........................................................................ 13
5.1.2QC Procedure ................................................................................................. 14
1 Identification
CyStain™ VitalCount QC Procedure | QC Manual | June 2021 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™ 1.8 and above
Manufacturer Sysmex Partec GmbH
REF CY-S-3061R-V2m
2 Introduction
4 CyStain™ VitalCount QC Procedure | QC Manual | June 2021
2 Introduction
2.1 About this document
This document will guide through the Quality Check (QC) procedure of the CyStain™
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™ Cube
6 V2m for measurements with the CyStain™ VitalCount reagent 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
and FCS Express™ templates corresponding to the used QC material LOT.
2.3 Installation and alteration
The first installation must be performed by authorised service personnel.
No alterations should be made to the scripts and templates, unless expressly permitted by
the manufacturer. After alteration of scripts or templates appropriate tests and trials must
be performed to ensure safe use.
2.4 Sysmex representatives
Find address and contact data of your local Sysmex representative at
www.sysmex-flowcytometry.com
2.5 Authorised distributors
To receive an overview of authorised distributors nearby, please contact your local Sysmex
representative.
3 Overview
CyStain™ VitalCount QC Procedure | QC Manual | June 2021 5
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™ templates are used to automatically analyse the results of QC
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 further information please refer to the
device manual.
NOTICE
Count Check Beads green specificity
This QC procedure was designed for the use with Count Check Beads
green (REF 05-4011_R). Similar products such as Count Check Beads
green (REF 05-4011) are not suitable for use.
Always use the recommended reagents.
Light source Item Content REF
Blue Laser Count Check Beads green 50 tests 05-4011_R
3 Overview
6 CyStain™ VitalCount QC Procedure | QC Manual | June 2021
3.4 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).
“LOT N° mismatch” will be displayed in the FCS Express™ templates, if a template not
matching the Count Check Beads 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.
Matching LOT and template
The LOT number (LOT No) of the Count Check Beads green is composed of
“NN00YYMMDD”. They are compatible with the script / template version, identical to the
first 4 digits of the LOT No“NN00”.
To check if the LOT matches, start the FCS Express™ template manually and type in the
LOT Noof the Count Check beads green. If the LOT Nodoes not match “LOT N° mismatch”
will be displayed.
Find the template at: “C:\ProgramData\PartecGmbH\Cube_18\templates\Quality Control”
4 Operation
CyStain™ VitalCount QC Procedure | QC Manual | June 2021 7
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™. Refer to FCS Express™ manuals and tutorials for detailed
information about the software.
4.2 Quality Check procedure
4.2.1 Setting up the Quality Check
Requirements
Logged in to CyView™ with privileges 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
Sample tube with 850 μl Count Check Beads green, see chapter 3.3 Quality Check
material
Sample tube with 1500 μl Sheath Fluid
Procedure
Figure 6:Selecting Work Mode
1. Select [Work Mode].
2. Switch Measure Mode Sample Source to “Sample Port”.
3. Connect the Sample tube with 850 µl Count Check Beads green.
4. Click [Start].
5. Adjust gain values in a way that the signals of the Count Check Beads green appear
exactly in the center of the quality gate “QC (CCB)” within the main Plot.
DQC Plot 1 DQC Plot 2
Figure 7:Adjust gain values
1E.g. VitalCount_A_AK01_Robby.cvc85
4 Operation
8 CyStain™ VitalCount QC Procedure | QC Manual | June 2021
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. Switch Measure Mode (Sample Mixing) to “High”.
12. Switch Measure Mode (Sample-to-Sample Cleaning) to ”Intensive”.
13. Switch back to “Prime Mode” and save the configuration file as …_Robby.
Result
The configuration 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 Check.
4.2.2 Running a Quality Check
The QC procedure controls background, laser power, optical alignment, gate positioning
and counting precision.
Requirements
Logged in to CyView™ with privileges of Main User or Administrator
LOT and FCS Express™ template match, see chapter 3.4 QC material LOT
dependency
CyStain™ VitalCount configuration is active
Priming has been performed
96-Well Plate is selected with QC material in the following order (e.g. A1)
- e.g. A1 well with 200 μl Count Check Beads green
4 Operation
CyStain™ VitalCount QC Procedure | QC Manual | June 2021 9
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. Select each with QC material and insert the Wellname “QC”. The correct order for
the QC material is important when measuring the wells.
6. Click “Back to CyView”.
Figure 11:CyView TrayLayout
4 Operation
10 CyStain™ VitalCount QC Procedure | QC Manual | June 2021
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.
If the beads signals are not within the predefined region, adjust the gain
values , see chapter 4.2.1 Setting up the Quality Check.
Results
The QC procedure results can be analysed in FCS Express™. Continue by analysing the
Quality Check with FCS Express™.
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