SYSMEX Ploidy User manual

For CyFlow™Robby 6 Autoloading Station with CyFlow™Ploidy Analyser (with CyView™ software)
Doc. No.: CY-S-3080-6PAIFUEN | Rev: 002 | Rev. date: 11-09-2020 | EN | CN 1671
CyFlow™ Ploidy Analyser
with CyFlow™ Robby 6 Autoloading
Station
Operating Manual

Table of contents
CyFlow™Robby 6 Autoloading Station | Operating Manual | September 2020 | Revision 002
3
Table of contents
1Identification ............................................................................................................5
1.1 Product information..........................................................................................5
1.2 Manufacturer.....................................................................................................5
2Presentation.............................................................................................................6
2.1 What other manuals are available? .................................................................6
2.2 What standards were applied for CE compliance? ........................................6
2.3 What typographical conventions are used in this manual?...........................6
2.3.1 Symbols in this document................................................................................7
2.3.2 Safety information ...........................................................................................7
3Safety........................................................................................................................9
3.1 General hazards................................................................................................9
3.2 Electrical hazards .............................................................................................9
3.3 Alterations to the device ..................................................................................9
4Instrument starting procedure..............................................................................10
5Priming / Initialization............................................................................................11
5.1Priming / Initialization process ......................................................................11
5.2 Work process..................................................................................................12
5.3 Shut down process.........................................................................................13
6Measurement with the Autoloading Station.........................................................14
6.1 Measure mode.................................................................................................14
6.2 General Procedure..........................................................................................16
6.3 Changing a rack..............................................................................................19
7Cleaning Procedure...............................................................................................20
7.1 Autoloader tray ...............................................................................................20
7.2 Sample Port.....................................................................................................20
7.3 Sheath Fluid and Waste bottle.......................................................................21
8Maintenance...........................................................................................................22
8.1 Regular maintenance......................................................................................22
8.2 Preventive maintenance and service.............................................................22
8.3 Transport and Storage....................................................................................22
8.4 Disposal...........................................................................................................23
9Technical data........................................................................................................24

Table of figures
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Table of figures
Figure 1: CyFlow™Robby 6 Autoloading Station Initialization .........................................10
Figure 2: User Login window...........................................................................................10
Figure 3: “PRIME” button (bright highlighted), “WORK” button and “CLEAN” button .......11
Figure 4: Go to “Measure” tab and choose the measure mode “Plate_10-40” (Example) 11
Figure 5: “WORK” is red highlighted................................................................................12
Figure 6: "CLEAN" is red highlighted...............................................................................13
Figure 7: Measure mode selection..................................................................................14
Figure 8: Changeable parameters of work step...............................................................15
Figure 9. Please insert a tray ..........................................................................................17
Figure 10. Please change tray or tray layout...................................................................17
Figure 11. Select applicable tray layout...........................................................................17
Figure 12: Layout Editor overview...................................................................................17
Figure 13: "CLEAN" symbol in the window (see down right corner).................................20

1 Identification
CyFlow™Robby 6 Autoloading Station | Operating Manual | September 2020 | Revision 002
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1 Identification
1.1 Product information
Name
CyFlow™Robby 6 Autoloading Station
Software
please see labelling of
CyFlow™Ploidy Analyser (with CyView™software)
REF
CY-S-3080-6
Versions
To be used in combination with CyFlow™Ploidy Analyser only!
CY-S-3039_V1 with CY-S-3080-6
CY-S-3039_V2 with CY-S-3080-6
CY-S-3039_V3 with CY-S-3080-6
This manual does not apply to any combination with CyFlow™Cube 6!
CY-S-3060R (with CyView™software) with CY-S-3080-6
CY-S-3060R (with CyFlow™software) with CY-S-3080-6
1.2 Manufacturer
Sysmex Partec GmbH
Arndtstraße 11a-b,
02826 Görlitz,
Germany
Phone [phone]
Fax [phone]
[e-mail]
www.sysmex-partec.com

2 Presentation
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2 Presentation
The CyFlow™Ploidy Analyser can be operated with or without the CyFlow™Robby 6
Autoloading Station.
This manual is only valid for CyFlow™Robby 6 Autoloading Station in combination with
CyFlow™Ploidy Analyser with CyView™software.
Installation and connection of the CyFlow™Robby 6 Autoloading Station is part of the
authorised service personnel responsibilities, please contact your local Sysmex
representative.
For general information about the CyFlow™Ploidy Analyser and its components please
refer to its respective labelling.
Read all supplied labelling thoroughly before using the device. Please keep this operating
manual for future reference.
There are product data sheets for the reagent kits and application notes available. Please
also refer to these documents.
If you have any questions about the content of this operating manual or the use of the
device, contact your local Sysmex representative.
2.1 What other manuals are available?
•CyFlow™Ploidy Analyser Operating Manual (Doc. No.: CY-S-3039IFUEN)
2.2 What standards were applied for CE compliance?
The system described in this manual is marked with a CE-mark, 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
•2011/65/EC on the restriction of the use of certain hazardous
substances in electrical and electronic equipment
2.3 What typographical conventions are used in this manual?
Read the Operating Manual as well as the associated labelling thoroughly before using
the device. Please keep the Operating Manual for future reference.
The Operating Manual will help operating the device. Emphasis lays on start-up and safe
operation of the device.
If you have any questions about the content of the Operating Manual or operating the
device, please contact your local Sysmex representative.

2 Presentation
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2.3.1 Symbols in this document
To make warnings more accessible, the following symbols are used to reference the kind
of hazard
1
.
Hazard
symbol
Meaning
General hazards
Biological hazards
Electrical hazards
Beware of electrical currents and electrical shocks.
2.3.2 Safety information
Safety information and warnings are marked by symbols and signal words. Hazards are
categorized 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
These symbols are in black and white throughout this document, even though they appear in colour on the device. Their
meaning is unchanged.

2 Presentation
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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.

3 Safety
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3 Safety
3.1 General hazards
CAUTION
Moving sample needle in the autoloader
When reaching into the autoloader tray, cutting injuries of fingers could
occur.
•Do not reach into the autoloader tray.
3.2 Electrical hazards
Please place the device in such a way, that the wiring is easily accessible
to unplug and does not suffer damages in any way. Only replace
removable wiring with adequate spare parts.
3.3 Alterations to the device
Unauthorized alterations to the device or the software result in risks
towards all user groups and the device itself. Unless permitted by the
manufacturer, the device must not be altered.

4 Instrument starting procedure
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4 Instrument starting procedure
LOG-IN and Start up
The power supply switch is found at the back of the CyFlow™Ploidy Analyser next to the
main supply cable. The CyFlow™Ploidy Analyser is, in default, set in a stand-by mode.
The full activation of the CyFlow™Ploidy Analyser requires pressing the button on the top
of the machine. The display screen must be lift-up first to access it.
This will start the embedded computer, automatically start the CyView™software and load
the last employed configuration.
The following initialization dialogue between the software and the hardware (CyFlow™
Ploidy Analyser with CyFlow™Robby 6 Autoloading Station) will appear. The five check-
boxes for Cleaning up, CVC-Validator, XML-configuration, PSX-Station-Add-on and
Searching Device should show a green tick.
The CyFlow™Robby 6 Autoloading Station initializes automatically (Initialization will be
audible).
Figure 1: CyFlow™Robby 6 Autoloading Station Initialization
The User Login window will open up allowing you to login with the regular user password:
Figure 2: User Login window
Login USER
Password Cube1

5 Priming / Initialization
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5 Priming / Initialization
5.1 Priming / Initialization process
There is a PRIME mode available as a Start Up process for the device. This process
includes cleaning and filling tubes with Sheath Fluid. If a new original CFG-file will be
loaded the PRIME mode is always selected. User defined configuration files can start in
PRIME or WORK mode, depend on the status during saving.
In the following cases the PRIME mode should be performed:
•Starting the instrument for the first time → Daily initialization
•After the Sheath Fluid bottle was filled
•As trouble shooting procedure (no/bad signals, blocking, etc.)
To start the priming process, please follow the instructions below:
1. Open a configuration file and select the initialization modus by clicking on the
Initialization button. Please notice that in all Partec Master Cfg-file the Prime mode
is preset.
Figure 3: “PRIME” button (bright highlighted), “WORK” button and “CLEAN” button
2. Choose an Automate Measure mode to include the Automate in the Initialization
process.
Figure 4: Go to “Measure” tab and choose the measure mode “Plate_10-40” (Example)
3. After pressing Start the system will start the priming process automatically and
guide through the program.

5 Priming / Initialization
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4. Connect a Sample Tube with Decontamination Solution (violet solution, Order No.
04-4010_R), press “Continue” and wait until the system finished.
5. Remove the Sample Tube, press “Continue” and wait until the system has
finished.
6. Connect the Sample Tube again, press “Continue” and wait until the system has
finished
7. At the end press “Continue”. The instrument will be cleaned and the priming
process ends.
5.2 Work process
Figure 5: “WORK” is red highlighted
•Choose the “WORK” button to measure and acquire data.

5 Priming / Initialization
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5.3 Shut down process
For the cleaning of the sample port a separate cleaning mode is available. The detail
procedure would be the following.
Figure 6: "CLEAN" is red highlighted
1. Select the “CLEAN” button by clicking on the “CLEAN” button.
2. After pressing Start the system will start the priming process automatically and
guide through the program.
3. Connect a Sample Tube with Cleaning Solution (green solution, Order No. 04-
4009_R) and press “Continue”.
4. Connect a Sample Tube with Decontamination Solution (violet solution, Order No.
04-4010_R) and press “Continue”.
5. Connect a Sample Tube with Sheath Fluid (Order No. 04-4007_R) and press
“Continue”.
6. After finishing the cleaning process CyView™will be shut down automatically.
7. Laser sources will also be switched off.
8. Switch off the PC
9. Close Windows (Start –Exit –Switch Computer Off)
10. To power off completely, use the main power switch at the back panel

6 Measurement with the Autoloading Station
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6 Measurement with the Autoloading Station
6.1 Measure mode
Each configuration file for the CyFlow™Robby 6 Autoloading Station offers a certain
number of measure modes.
•Select the registry page “MEASURE” and choose one of the default measure
modes.
Figure 7: Measure mode selection
Sample supply
Measmode
Process
Sample Port
(manual mode)
Analyse all
runs sample until its levels reaches the
stop electrode
VC of volume
a sample volume can be pre-selected
VC electrodes
START and STOP electrodes of the
sample port are used to analyse a sample
volume of 200 µl
Autoloader tray
(automate mode)
Plate_10-40
a volume between 10µl and 40µl can be
pre-selected for the measurement from a
96-Well-Plate
Plate_40-100
a volume between 40µl and 100µl can be
pre-selected for the measurement from a
96-Well-Plate
Plate_100-180
a volume between 100µl and 180µl can
be pre-selected for the measurement from
a 96-Well-Plate
Tubes_Volume
a volume can be pre-selected for the
measurement from tubes
Table 1: Definitions of different measurement modes (measmode)
The measure modes "Analyse all", "VC with volume" and "VC electrodes" deliver samples
from the Sample Port (manual mode). When operating the Robby 6 Autoloading Station
optimization of instrument settings (Gain values, definition of regions, etc.) can be done

6 Measurement with the Autoloading Station
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using the Sample Port (manual mode) before starting Sample Analysis with delivery from
the Autoloader tray (Automate mode). The other measure modes deliver samples from
the Autoloader tray of the Robby 6 Autoloading Station and define different ranges of
sample volume.
Figure 8: Changeable parameters of work step
Within this window it is necessary to place the “Device” selection to “AL 1” → the different
conditions of the measure modes are only then visible and speed and/or analysis volume
settings are changeable.
The analysis volume and the analysis speed for the respective volume range can be
selected in the field “Changeable parameters” (see below).
NOTICE
The sample uptake will be higher than the analysis volume.
Sample uptake
(fixed)
Analysis volume
(User selectable)
For 96-well-plate
50 µl
10 –40 µl
120 µl
40 –100 µl
200 µl
100 –180 µl
For tubes
400 µl + X
X = 10 –2000 µl
Table 2: Volume ranges of the Robby 6 Autoloading Station

6 Measurement with the Autoloading Station
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6.2 General Procedure
1. Open a configuration file .
2. Select a measure mode for the manual operation (for example “Analyze all” → go to
registry page “MEASURE” and selected the mode)
3. Connect a Sample Tube filled with 1 ml of sample to the manual sample port.
A distinct sound will occur, if the Sample Tube is inserted correctly.
4. Press “Start” →After the pre-run phase acquisition data will be displayed.
5. Optimize gain and threshold values and define regions if required.
6. When all instrument settings are optimized for your measurement press “Stop”.
7. Clean the sample port.
a) Connect a Sample Tube filled with 1.5 ml Cleaning Solution and press “CLEAN”
.
b) Repeat the procedure with 1.5 ml Sheath Fluid
8. Select the main registry page “Measure”. Within this window choose a measure mode
for the Autoloading Station.
9. Place the “Device” selection to “AL1” --> The different conditions of the measure-
modes are visible and speed and/or analysis volume are changeable.
10. Start the automate mode by pressing “Start” .
11. After the “Tray Information” window opens, type in a name for the tray to be analysed
and press “Measure New Tray”. If the window opens not directly, please check the
window bar.
12. The system recognizes if there is no tray or if the tray is not compatible to the selected
tray layout.

6 Measurement with the Autoloading Station
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Figure 9. Please insert a tray
Figure 10. Please change tray or tray
layout
Figure 11. Select applicable tray
layout
13. The layout editor will open (layout format depends on selected tray format: 96-well or
tubes (see below)), to define the position of samples and the names the individual
samples in a 96-well plate or the tube rack.
Figure 12: Layout Editor overview
14. In order to highlight a certain well (or tube) and label it for analysis simply double-click
into the respective well and type in a desired sample name followed by “Enter”. In this
way, all tray positions containing an actual sample should be labelled.
NOTICE
All tray positions without a given name will not be analysed!
15. After selecting the tray position and the labelling procedure, please click “Back to
CyView” .
Information whether inserted tray
matches selected layout
(Green = correct, Red = not correct)

6 Measurement with the Autoloading Station
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16. Start the analysis, by pressing “Start”.
The CyFlow™Robby 6 Autoloading Station will immediately move to the first selected tray
position to take-up the defined sample volume of the first sample. Next in sequence, the
sample will be forwarded towards the flow cuvette. Following a fast forward, the sample
delivery speed will lower to the selected value. A short pre-run phase of 5 µl sample will
stabilize the sample flow. During pre-run phase data will be visible on screen but will be
deleted with entry into the regular run phase.The predefined sample volume will be
analysed and at the end of the analysis data are automatically saved in .fcs format to the
following destination: C:\Cube_15\data or the pre-selected folder.
The file name is formed by: [date]_[time]_[file-index]_[customer-given name]
Information about the process will be shown in the “Tray Operation Process” window.
The FCS-file index value can be modified with the shown
selector:
NOTICE
After each sample analysis, a cleaning step to wash the sample needle is
initiated before proceeding with the next sample.
The process is stopped after the analysis of the last sample.
Unlabelled wells will not
be analysed

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6.3 Changing a rack
Three rack types are available:
•Rack for 2 x 48 well plates (see picture “48 wells”)
•Rack for 2 x 96 well plates (see picture “96 wells”)
•Tube rack (see picture “Tubes”)
To change a rack to another rack, pull out
the tray slide from the autoloader tray and
carefully remove the rack from the the top
of the tray slide, so that you see the bare-
naked tray slide top.
Attach the tube rack to the tray slide that
the notches on the tray slide fit the small
holes on the side of the rack. Position A1
(marked with “A1”) of the tube rack is in
the upper right position.
Push the tray slide completely into the
autoloader tray.
Tray slide
Rack for
2 x 96
well
plates
Tube rack

7 Cleaning Procedure
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7 Cleaning Procedure
7.1 Autoloader tray
The sample needle of the CyFlow™Robby 6 Autoloading Station will be cleaned
automatically between each sample and at the end of each measuring sequence.
7.2 Sample Port
The sample port of the CyFlow™Ploidy Analyser can be cleaned using the Cleaning
Solution (green solution, Order No 04-4009_R) followed by a Sample Tube with Sheath
Fluid. This procedure allows to reduce significantly the cross contamination and reduce
the background.
For this procedure, connect a Sample Tube with 1.5 ml Cleaning Solution and clean the
instrument by clicking on the “CLEAN” symbol .
The instrument will perform one cleaning cycle. Repeat the procedure with a Sample
Tube filled with 1.5 ml Sheath Fluid.
Figure 13: "CLEAN" symbol in the window (see down right corner)