SYSMEX CyFlow Cube 6 V2m User manual

With CyView™ 1.8
Doc. No.: CY-S-3061R-V2mIFUEN | Rev: 002 | Rev. date: 03-02-2020 | EN | CN 1432
CyFlow™ Cube 6 V2m
Operating Manual

Table of contents
CyFlow™Cube 6 V2m | Operating Manual | February 2020
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Table of contents
1Introduction.......................................................................................................8
1.1 About this Operating Manual...............................................................................8
1.2 Typographical conventions .................................................................................8
1.2.1 Safety information...............................................................................................8
1.2.2 Text highlights.....................................................................................................9
1.3 General conditions............................................................................................10
1.4 CE compliance..................................................................................................10
1.5 Sysmex representatives....................................................................................11
1.6 Authorised distributors......................................................................................11
2Safety...............................................................................................................12
2.1 Intended Use ....................................................................................................12
2.2 Prohibited use...................................................................................................12
2.3 Reasonably foreseeable misuse.......................................................................12
2.4 User definition...................................................................................................12
2.4.1 User qualification groups...................................................................................12
2.4.2 User Qualification Matrix...................................................................................13
2.5 Environmental conditions..................................................................................13
2.6 Prohibition and warning signs on the device .....................................................13
2.7 Personal protective equipment..........................................................................14
2.8 General safety ..................................................................................................14
2.9 Laser radiation hazards ....................................................................................14
2.10 Electrical hazards..............................................................................................15
2.11 Alterations to the device....................................................................................15
3Overview..........................................................................................................16
3.1 Device...............................................................................................................16
3.2 Components of the device ................................................................................18
3.2.1 Control elements...............................................................................................18
3.2.2 Computer interface ports...................................................................................18
3.2.3 Sheath Fluid and Waste bottle..........................................................................18
3.2.4 Sample port with electrodes..............................................................................19
3.2.5 Type plate.........................................................................................................19
3.3 Scope of delivery ..............................................................................................20
3.4 Accessories and spare parts.............................................................................21
4Transport and storage....................................................................................22
5Installation.......................................................................................................23
5.1 Positioning the device.......................................................................................23
5.2 Installation and uninstallation............................................................................23
6Operation.........................................................................................................24
6.1 Start-up procedure............................................................................................24
6.1.1 Switching on the device....................................................................................24
6.1.2 Logging in.........................................................................................................24

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6.1.3 Priming the device ............................................................................................25
6.1.4 Performing a quality check................................................................................26
6.1.5 Analysing a quality check..................................................................................27
6.2 Performing a measurement (Sample Port)........................................................28
6.3 Saving acquired data........................................................................................29
6.4 Performing intermediate cleaning......................................................................29
6.5 Shutdown procedure.........................................................................................30
6.5.1 Shutdown cleaning............................................................................................30
6.5.2 Switching off the device ....................................................................................31
6.6 Software operation............................................................................................31
7Troubleshooting..............................................................................................32
7.1 Fault, cause and remedy...................................................................................32
7.1.1 Sheath Fluid, waste and other fluids .................................................................32
7.1.2 Calibration and Count Check Beads (low, medium, high)..................................32
7.1.3 Measurements and data acquisition..................................................................33
8Maintenance....................................................................................................34
8.1 Maintenance overview......................................................................................34
8.2 Maintenance procedures...................................................................................35
8.2.1 Sheath Fluid refilling .........................................................................................35
8.2.2 Inline Filter renewal...........................................................................................35
8.3 Other maintenance ...........................................................................................36
8.3.1 Device cleaning ................................................................................................36
8.4 Technical service..............................................................................................37
8.4.1 Preventive maintenance....................................................................................37
8.4.2 Defective device ...............................................................................................37
9Disposal...........................................................................................................38
9.1 Disposal of device.............................................................................................38
9.2 Disposal of components....................................................................................38
9.3 Waste disposal .................................................................................................38
9.4 Sheath Fluid disposal........................................................................................38
10 Technical data.................................................................................................40
10.1 Environmental conditions..................................................................................40
10.2 Device...............................................................................................................40
10.3 Optics ...............................................................................................................41
10.4 Fluidics .............................................................................................................42
11 Software ..........................................................................................................43
11.1 User Management ............................................................................................43
11.1.1 Login..........................................................................................................43
11.1.2 User Administration....................................................................................43
11.2 Overview...........................................................................................................45
11.2.1 Title bar......................................................................................................45
11.2.2 Drop down menu .......................................................................................45
11.2.3 Main window..............................................................................................46

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11.2.4 Controls.....................................................................................................47
11.3 Data management ............................................................................................48
11.3.1 Open (.fcs).................................................................................................48
11.3.2 Save (.fcs) .................................................................................................48
11.3.3 Open Configuration....................................................................................48
11.3.4 Save Configuration ....................................................................................48
11.4 Data acquisition controls...................................................................................49
11.4.1 Acquisition controls....................................................................................49
11.4.2 Device real time display.............................................................................49
11.5 Settings.............................................................................................................50
11.5.1 Compensation............................................................................................51
11.5.2 Plots ..........................................................................................................52
11.5.3 Results.......................................................................................................53
11.5.4 Regions .....................................................................................................54
11.5.5 Acquisition.................................................................................................59
11.5.6 Measure (Sample Port)..............................................................................60
12 Annex...............................................................................................................63
12.1 Abbreviations....................................................................................................63
12.2 List of software commands ...............................................................................64

Table of figures - Figures
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Table of figures - Figures
Figure 1: Front and left side of the device .......................................................................16
Figure 2: Ports for external devices.................................................................................17
Figure 3: Rear side of the device.....................................................................................17
Figure 4: Sample port at the right side of the device .......................................................18
Figure 5: Type plate........................................................................................................19
Figure 6: Selecting Prime Mode......................................................................................25
Figure 7: Selecting QC Mode..........................................................................................26
Figure 8: Selecting Work Mode.......................................................................................29
Figure 9: Selecting FCS-File Storage..............................................................................29
Figure 10: Intermediate Cleaning....................................................................................30
Figure 11: Selecting Shutdown Cleaning Mode...............................................................30
Figure 12: Login and system check window....................................................................43
Figure 13: User administration window (exemplary)........................................................44
Figure 14: Main window (5Pl.cvc85 configuration active)................................................46
Figure 15: File operations ...............................................................................................47
Figure 16: Device real time display .................................................................................47
Figure 17: Acquisition controls........................................................................................47
Figure 18: Intermediate Cleaning....................................................................................47
Figure 19: Compensation tab..........................................................................................51
Figure 20: Plots register (Histogram)...............................................................................52
Figure 21: Plots register (Dot plot)...................................................................................52
Figure 22: Results register..............................................................................................53
Figure 23: Creating a quadrant region.............................................................................55
Figure 24: Creating a vertical Region..............................................................................55
Figure 25: Create a polygonal region..............................................................................56
Figure 26: display options...............................................................................................57
Figure 27: Show Regions (density colored).....................................................................57
Figure 28: Show Regions (unicolored)............................................................................57
Figure 29: Show all events + Regions (unicolored) .........................................................57
Figure 30: Region properties...........................................................................................58
Figure 31: Acquisition register.........................................................................................59
Figure 32: Measure register............................................................................................60
Figure 33:Acquisition process for all Sample Port Measure Modes.................................61
Figure 34: Workstep register...........................................................................................62

Table of figures - Tables
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Table of figures - Tables
Table 1: Text highlights.....................................................................................................9
Table 2: Representative's contacts .................................................................................11
Table 3: User Qualification Matrix ...................................................................................13
Table 4: Safety signs on the device.................................................................................14
Table 5: Personal protective equipment (PPE)................................................................14
Table 6: Signs on the type plate of the device.................................................................19
Table 7: Scope of delivery and operation........................................................................20
Table 8: Reagents...........................................................................................................21
Table 9: Accessories and spare parts.............................................................................21
Table 10: Measure Modes ..............................................................................................28
Table 11: Maintenance activities.....................................................................................34
Table 12: Roles and privileges........................................................................................44
Table 13: Drop down menu structure for each configuration (Mainuser) .........................45
Table 14: Drop down menu structure for each configuration (User).................................46
Table 15: Acquisition controls .........................................................................................49
Table 16: Device real time display elements...................................................................49
Table 17: Manual Sample Port Measure Modes..............................................................62

1 Introduction
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CyFlow™ Cube 6 V2m | Operating Manual | February 2020
1 Introduction
1.1 About this Operating Manual
This Operating Manual will help you to operate your CyFlow™ Cube device. Emphasis is
placed on the installation, start-up and safe operation of the device.
The basic principles of flow cytometry can be found in the scientific literature (e.g. Howard
M. Shapiro, Practical Flow Cytometry, Wiley 2003).
This Operating Manual comes with the device. Read this Operating Manual thoroughly
before using the device. Please keep this Operating Manual for future reference.
This Operating Manual is divided in two parts. The first part, chapter 1 to 10, gives the
user all necessary information for safe handling, scope of delivery, to set up the device
and how to operate the device properly. The general use of the software and the typical
workflows are described in chapter 6, this chapter also is suitable to get to know the
functioning of your device.
In the second part, chapter 11, you will find a description of all software functions and a
detailed description of the user interface. This chapter is for reference.
There are product data sheets and assay manuals for the reagent kits and general
application notes available. Please also refer to these documents.
If you have any questions about the content of this manual or the use of the device,
contact your local Sysmex representative.
1.2 Typographical conventions
1.2.1 Safety information
Safety information and warnings are marked by symbols and signal words. Hazards are
categorised into four levels. All warnings are structured according to the same model. The
type of hazard is stated after the signal word. Then the consequences that may result
from the hazardous situation are described. And finally, how the hazardous situation can
be avoided. If applicable a hazard symbol is portrayed, to indicate the kind of hazard.
DANGER
Names the source of the hazard
Describes the consequences of the hazard. This will result in death or
severe personal injury.
•Specifies the steps that must be taken to eliminate the hazard.
WARNING
Names the source of the hazard
Describes the consequences of the hazard. This could result in death or
severe personal injury.
•Specifies the steps that must be taken to eliminate the hazard.

1 Introduction
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CAUTION
Names the source of the hazard
Describes the consequences of the hazard. This could result in minor
injury.
•Specifies the steps that must be taken to eliminate the hazard.
NOTICE
Names the source of the hazard
Describes the consequences of the hazard. This could result in material
damage.
•Specifies the steps that must be taken to eliminate the hazard.
INFORMATION
Gives further information about the device or procedure.
1.2.2 Text highlights
To ease the reading flow, the following kinds of text highlights are used in this manual.
Table 1: Text highlights
Style
Meaning
[Brackets]
Describes an interactive element of
software. This includes paths, buttons and
tabs.
Example: Press the [Start] button.
Italic 11 pt
References instances for interaction
(names thereof) in instructions.
Example: Push the On switch on the top of
the device.
It may also be used as chapter reference.
Example: For more information, please
refer to chapter 11.1 User Management.
Italic 8 pt
Used for captions of figures (figures,
tables).
Example: Figure 20: General overview, Table 2:
Safety information
It may also be used for additional
descriptive text.
Example: Electrical hazards Beware of
electrical currents and electrical shocks
“Quotes”
Describes reference sources.
Example: Please consider our “General

1 Introduction
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Terms and Conditions of Sale and
Delivery” […]
Bold
Describes headlines of subtopics, which
need no independent chapter.
Example: Qualified personnel
Describes also specially highlighted
keywords.
Example: Names the source of the
hazard
Underlined
References external hyperlinks.
Example: www.sysmex-partec.com
1.3 General conditions
Ensure that the following conditions are met when working with the device:
•This Operating Manual must be read prior to using the device.
•Report any recurring faults or problems to your local Sysmex representative.
Sysmex Partec GmbH does not accept liability for any damage or personal injury arising
from:
•Unauthorised modifications or manipulation of the device;
•Improper use;
•Use of non-approved accessories;
•Improper handling;
•Non-compliance with this Operating Manual.
Not following these conditions will impair the safe use of the device, its components and
the safety of the user.
Sysmex Partec GmbH regulates the intended purpose of its products in the instructions
for use. The manufacturer assumes no responsibility for any application deviating from
the instructions for use stated in the product documentation (Off Label Use). We
expressly emphasize that in the event of use contrary to the intended purpose the liability
rests solely with the user.
1.4 CE compliance
The device is marked with a CE mark of conformity, which confirms the
compliance with the essential requirements of the following European
Directives:
•2014/35/EC on electrical equipment designed for use within certain
voltage limits;
•2014/30/EC on electromagnetic compatibility