Related Manuals for SYSMEX CyFlow Cube 6 V2m
Summary of Contents for SYSMEX CyFlow Cube 6 V2m
- Page 1 CyFlow™ Cube 6 V2m Operating Manual With CyView™ 1.8 Doc. No.: CY-S-3061R-V2mIFUEN | Rev: 002 | Rev. date: 03-02-2020 | EN | CN 1432...
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Page 3: Table Of Contents
Typographical conventions ................. 8 1.2.1 Safety information ....................8 1.2.2 Text highlights ..................... 9 General conditions .................... 10 CE compliance ....................10 Sysmex representatives ..................11 Authorised distributors ..................11 Safety ....................... 12 Intended Use ....................12 Prohibited use ....................12 Reasonably foreseeable misuse ............... - Page 4 Table of contents 6.1.3 Priming the device .................... 25 6.1.4 Performing a quality check ................26 6.1.5 Analysing a quality check .................. 27 Performing a measurement (Sample Port) ............28 Saving acquired data ..................29 Performing intermediate cleaning ..............29 Shutdown procedure ..................
- Page 5 Table of contents 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 ................
- Page 6 Table of figures - Figures 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 ......................
- Page 7 Table of figures - Tables 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.
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Page 8: Introduction
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. -
Page 9: Text Highlights
1 Introduction 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. -
Page 10: General Conditions
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;... -
Page 11: Sysmex Representatives
1 Introduction 1.5 Sysmex representatives Find address and contact data of your local Sysmex representative also at www.sysmex-partec.com. Table 2: Representative's contacts Sysmex Europe GmbH Europe, Middle East and Africa Bornbarch 1, 22848 Norderstedt, Germany Phone: +49 40 5 27 26-0... -
Page 12: Safety
Instructed personnel have to be trained by qualified personnel or personnel authorised by Sysmex to operate the device within the scope of the intended use. They have to be able to assess if the device can be safely used and are proficient in handling hazardous substances. -
Page 13: User Qualification Matrix
Qualified personnel Qualified personnel have in-depth knowledge of the device and the applications. They have been trained by personnel authorised by Sysmex to operate the device, to perform cleaning and certain maintenance operations. Qualified personnel have a scientific or technical education and several years of experience in flow cytometry and are proficient in handling hazardous substances. -
Page 14: Personal Protective Equipment
Always meet the national and international guidelines and regulatory standards for PPE (personal protective equipment). Find Safety Data Sheets to our products at www.sysmex-partec.com 2.9 Laser radiation hazards The device is equipped with a class IIIb laser unit. If the housing of the device is closed, the laser class of the laser unit is classified as a laser class I (EN 60825-1). -
Page 15: Electrical Hazards
2 Safety Only authorised service personnel is allowed to open the housing of the device. Laser light of laser class IIIb can be emitted if the housing of the device is damaged or the laser protection is removed. Serious injuries of the eyes and the skin are the results of emission by laser light of class IIIb lasers. -
Page 16: Overview
3 Overview 3 Overview 3.1 Device NOTICE Glass parts breakable Objects put on the glass top or display of the device damage or may break the glass. • Do not place any objects on or scratch the glass top or display of the CyFlow™... - Page 17 3 Overview Figure 2: Ports for external devices Item Item Item USB port HDMI port Serial port Ethernet port USB port Ethernet port Audio port Audio port USB port USB port USB port DVI port Keyboard port Mouse port Figure 3: Rear side of the device Item Item Tubing connection Waste bottle...
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Page 18: Components Of The Device
3 Overview Figure 4: Sample port at the right side of the device Item Item Start electrode Sample holder Stop electrode Sample port injection needle Sample tube 3.2 Components of the device The device contains the flow cuvette, the optics, the fluidics, the computer unit and data acquisition electronics. -
Page 19: Sample Port With Electrodes
3 Overview 3.2.4 Sample port with electrodes The Sample port is located on the right side of the device. The Sample port holds the Sample tube during the measurement. The start and stop electrodes of the Sample port allow the independent determination of exactly 200 μl volume for each sample. -
Page 20: Scope Of Delivery
20% - 85% 3.3 Scope of delivery The following items are available through Sysmex and distributors authorised by Sysmex, also the list should help the user identifiy what is already part of the scope of delivery. -
Page 21: Accessories And Spare Parts
3 Overview 3.4 Accessories and spare parts Visit our website http://www.sysmex-partec.com or contact your local Sysmex representative for further information about our products. Table 8: Reagents Item Content REF No. Sheath Fluid 5000 ml 04-4007_R Sheath Fluid tap 1 piece... -
Page 22: Transport And Storage
4 Transport and storage 4 Transport and storage In order to transport the device to a different location all external data and supply connections have to be disconnected. The device should be carried in an upright position. The device is supplied in packaging that protects it against damage and contamination. Please retain the packaging. -
Page 23: Installation
5 Installation 5 Installation 5.1 Positioning the device Carefully select the place where to position and operate the device, it should not be moved without disconnecting its components. Comply with the following criteria when positioning the device: • Place the device on a solid, dry and clean horizontal surface. •... -
Page 24: Operation
6 Operation 6 Operation Due to heavy use of software-related content in the following chapter, please also refer to chapter 11 Software. 6.1 Start-up procedure NOTICE Old Sheath Fluid Old Sheath Fluid affects the sample flow through the flow cuvette. •... -
Page 25: Priming The Device
6 Operation Requirements • The login dialogue is displayed. • User access must be set up. • Login and password must be known to log into the software. Procedure 1. Enter your login. 2. Enter your password. 3. Click [Login] or press [Enter]. 6.1.3 Priming the device Prime mode is available as a start-up process for the device. -
Page 26: Performing A Quality Check
6 Operation 6.1.4 Performing a quality check NOTICE Specific quality check procedures It is recommended to perform a suitable quality check procedure for the planned application • Refer to the particular daily quality check procedures described within the specific assay manuals Calibration Beads A quality check (QC) procedure is available for the device. -
Page 27: Analysing A Quality Check
6 Operation INFORMATION Gain values Controls for Gain adjustments are only available at Main User Level or above. 6.1.5 Analysing a quality check INFORMATION FCS Express™ opens automatically once the Quality Check procedure has finished. The Quality Check (QC) is analysed automatically by FCS Express™. Requirements •... -
Page 28: Performing A Measurement (Sample Port)
6 Operation 6.2 Performing a measurement (Sample Port) NOTICE Sample Preparation High particle concentrations might clog the device. • Dilute or filter sample if necessary • Mix sample well before analysis INFORMATION Refer to specific measurement procedures in the respective assay and reagent labelling for detailed descriptions. -
Page 29: Saving Acquired Data
6 Operation Figure 8: Selecting Work Mode Procedure 1. Select [Work mode]. 2. Connect the Sample tube to the Sample port until the Sample tube audibly clicks. 3. Choose Measure mode and define parameters. 4. Press [Start]. 5. If a stop condition is set, wait until acquisition stops. If no stop condition is set, click [Stop] to stop the acquisition. -
Page 30: Shutdown Procedure
6 Operation Figure 10: Intermediate Cleaning INFORMATION Intermediate Cleaning Intermediate Cleaning reduces the possibility of cross contamination and background signals. Requirements • Sample tube with 2 ml Cleaning Solution • Sample tube with 2 ml Sheath Fluid Procedure 1. Connect a Sample tube filled with Cleaning Solution. 2. -
Page 31: Switching Off The Device
Refer to the FCS Express™ manual and tutorials for detailed information about the software. Designated FCS Express™ templates for reporting are provided by Sysmex. Refer to the specific assay manuals for guidance. CyFlow™ Cube 6 V2m | Operating Manual | February 2020... -
Page 32: Troubleshooting
7 Troubleshooting 7 Troubleshooting 7.1 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. 7.1.1 Sheath Fluid, waste and other fluids Fault Remedy... -
Page 33: Measurements And Data Acquisition
7 Troubleshooting Fault Remedy The result of the Calibration Check within the software if you have loaded the correct Beads measurement is not configuration file for your measurement. in the preselected regions of Shake the bottle vigorously (e.g. by vortexing) and repeat the original configuration the measurement. -
Page 34: Maintenance
8 Maintenance 8 Maintenance Servicing is to be performed by an authorised service engineer. Please contact your local Sysmex representative for further instructions. Table 11: Maintenance activities Activity Qualification requirement Regular maintenance Instructed personnel, Qualified personnel, Authorised service personnel Other maintenance... -
Page 35: Maintenance Procedures
8 Maintenance Procedure Frequency Chapter Activity Preventive Every 12 months Technical service maintenance or if troubleshooting applies 8.2 Maintenance procedures 8.2.1 Sheath Fluid refilling NOTICE Bent Tubing When screwing or unscrewing a bottle and its respective Cap, it is advantageous to twist the bottle instead of the lid. •... -
Page 36: Other Maintenance
8 Maintenance 8. Move the Cap gently up and down several times while keeping the Inline Filter covered in Sheath Fluid to remove air bubbles from the Inline Filter. 9. Screw down the Cap by turning the Bottle. Do not twist the Tubing and the Sensor cable. -
Page 37: Technical Service
Preventive maintenance must be realised by Authorised service personnel of Sysmex only. 8.4.2 Defective device Treatment of defective devices can be realised at the installation site or at Sysmex localities. How to deal with the defective device is determined by how grave the errors are. -
Page 38: Disposal
9.1 Disposal of device Electrical and electronic equipment must be disposed of separately from normal waste. Please contact your local Sysmex representative, since this device must be specially treated before disposal. 9.2 Disposal of components Generally, all components and fluids must be disposed of in accordance with your local regulations and acceptable laboratory procedures. - Page 39 9 Disposal 2. Secure Cap and Tubing on a clean surface in a stable manner. 3. Dispose of Sheath Fluid according to your local legislation and its associated labelling. 4. Screw down the Cap by turning the Bottle. Do not twist the Tubing and the Sensor cable.
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Page 40: Technical Data
10 Technical data 10 Technical data INFORMATION This equipment has been tested and found to comply with the limits for a Class A digital device, pursuant to part 15 of the FCC Rules. It has also been tested and found to comply with the CE directive for Electomagnetic Compatibility. -
Page 41: Optics
10 Technical data Item Specification EMC class Class A Degree of protection IP 20 (according to IEC 60529) Noise level < 80 dBA Device check Count Check Beads (low, medium, high) Calibration Beads 1 µm Concentrate Calibration Beads 3 µm, ready-to-use 0.1 μm to 100 μm Particle size range Maximum data acquisition... -
Page 42: Fluidics
10 Technical data 10.4 Fluidics Item Specification Fluid system Completely closed system for Sheath Fluid and sample volumes No fluid droplets or aerosols generated nor released from the device The pressure of the closed system is below 500 mbar Flow cuvette Synthetic quartz flow cuvette with centric flow channel (capillary diameter 350 μm ×... -
Page 43: Software
11 Software 11 Software The CyFlow™ Cube 6 V2m is equipped with the CyView™ software for operation of the device. This chapter describes the software functions. Performing routine tasks using the software is described in chapter 6 Operation. 11.1 User Management 11.1.1 Login Figure 12: Login and system check window A login and a password will be given to you by a Main User or during the installation of the... - Page 44 11 Software Figure 13: User administration window (exemplary) Procedure 1. Enter Login. 2. Enter Password. 3. Click [User Administration]. Table 12: Roles and privileges Role Privileges Administrator Restricted to Authorised service personnel. Administrators can create Administrator, Main User and User logins.
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Page 45: Overview
11 Software 4. Choose Administrator or Main User role (if none is selected, the User role is applied). 5. Click [Create Account]. Delete an account (Administrator / Main User) Procedure 1. Enter Name. 2. Click [Delete Account]. Changing password (Administrator / Main User) Procedure 1. -
Page 46: Main Window
11 Software Table 14: Drop down menu structure for each configuration (User) File Tools Info AddOns Save (.fcs) FCS Express Open Manual Open Configuration Device Information (.cfg) Exit Log File About CyView™ 11.2.3 Main window Figure 14: Main window (5Pl.cvc85 configuration active) Description Description File operations... -
Page 47: Controls
11 Software 11.2.4 Controls 1 2 3 4 Figure 15: File operations Description Description Open (.fcs) FCS-File Indexing (Switch indexing of Filenames on/off) Save (.fcs) Prime Open Configuration (.cfg) Work Save Configuration (.cfg) Clean and shutdown Cube Figure 16: Device real time display Description Description Fluid level indicator... -
Page 48: Data Management
11 Software 11.3 Data management Data can be managed either using the dropdown menus or the file operations, for more information please refer to chapter 11.2 Overview. INFORMATION Data Files Measurement data will be stored in the FCS format. The FCS file will contain all measured data and the measurement settings (e.g. -
Page 49: Data Acquisition Controls
11 Software 11.4 Data acquisition controls 11.4.1 Acquisition controls The Acquistion controls allow the user to operate the device during data acquisition. Table 15: Acquisition controls Symbol Control Description [Start] Starts the selected procedure [Continue] If paused, the procedure will be continued. During a procedure, the current step will be [Skip] skipped. -
Page 50: Settings
11 Software Depiction Label Description Shows a warning when Sheath Fluid level Fluid or waste levels become indicator critical Displays the flow rate in events Events (/sec) per second Shows total number of Data (kPart) acquired events in kiloparticles Shows elapsed time in Time (sec) seconds Shows measured volume in... -
Page 51: Compensation
11 Software 11.5.1 Compensation The Compensation tab provides controls allowing you to calculate fluorescence compensation. The bottom left buttons beneath the slide bar enable and disable compensation. Figure 19: Compensation tab Switch Compensation ON / OFF Show / Hide overcompensated particles Clear compensation settings Load compensation settings Save compensation settings... -
Page 52: Plots
11 Software 11.5.2 Plots The Plots register shows and defines the individual plot properties. Number, type (histograms, dot plots) and position of the plots are defined in the configuration file. Choose different Configuration files for different layouts. INFORMATION Modification of Plots Individual plots can be selected using the arrow keys. -
Page 53: Results
11 Software Property Description Plot Y-Axis Parameter Parameter to be displayed on the y-axis Log Scale Changes the y-axis scaling from linear to logarithmic scale Scaling Switches autoscaling of the y-axis on/off Density* Switch autoscale ON/OFF ▲ Alt+ / ▼ Alt- Settings* “0”... -
Page 54: Regions
11 Software Property Description Name Defines the result name (enter manually) Numerator Events Region 1 Defines first numerator Events Region2 Defines second numerator Defines operator bewtween numerators: „+“, „-“, „x“ and „/“ are Operator possible Denominator Events Region 3 Defines first denominator Events Region 4 Defines second denominator Defines operator bewtween denominators: „+“, „-“, „x“... - Page 55 11 Software Figure 23: Creating a quadrant region Procedure 1. Move the cursor into the dot plot and right-click. 2. Select [Create Quadrants]. Edit quadrant region Move the cursor into the plot and keep the left mouse button pressed to adjust quadrants. Approach individual points with the cursor and keep the left mouse button pressed to create asymetric quadrants.
- Page 56 11 Software Edit vertical or horizontal Regions Move the cursor into the plot and keep the left mouse button pressed to adjust the intersection of horizontal and vertical Regions. Create a polygonal region Polygonal regions are only available within dot plots. Figure 25: Create a polygonal region Procedure 1.
- Page 57 11 Software Gating Figure 26: display options Procedure 1. Right-click in a histogram or Dot Plot (outside of a region). 2. Select any existing region (Reg 1-Reg x) which is labelled with [Color gating on]. 3. Choose display option. Display option Description Show all events Displays all events in pseudo 3D color...
- Page 58 11 Software Region Properties • Edit regions: Use [Alt]+ right-click within the region in the histogram / Dot Plot to edit it. • Use the arrow keys to switch between regions. Confirm modifications by pressing [Accept]. Figure 30: Region properties Property Description Name...
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Page 59: Acquisition
11 Software 11.5.5 Acquisition Multiple trigger parameters are logical “OR” connections. Figure 31: Acquisition register Property Description Light Source Flags “Laser” […] X selects the active light sources in the device Trigger Parameter Flags “FSC”, “SSC”, […], “FL4” select trigger parameters Gain Settings The bars set the PMT signal amplification for the individual optical parameter in voltage (0 –... -
Page 60: Measure (Sample Port)
11 Software 11.5.6 Measure (Sample Port) Figure 32: Measure register Automatic functions INFORMATION Autosave Autosave does not work, when the measurement is finished by clicking [end]. Property Description Autostart Activates automatic start of acquisition. With each new Sample tube the next measurement will be started until the [Stop] button is pressed. - Page 61 11 Software Measure Mode NOTICE Cleaning Cycles The different measure modes handle the cleaning differently • [Analyze all] and [VC Electrodes] include an automatic cleaning cycle after sample acquisition. The cleaning cycle will not start, if the measurement is terminated with the [End] button. •...
- Page 62 11 Software Table 17: Manual Sample Port Measure Modes Measure Mode Description True Volumetric Absolute Counting. The start and stop VC Electrodes electrode are used to measure a defined volume of 200 µl. VC of Volume An adjustable predefined volume is analysed. Analyze all Continuous acquisition of the complete sample.
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Page 63: Annex
12 Annex 12 Annex 12.1 Abbreviations Abbreviation Explanation .fcm | CFG Configuration file extension Digital Visual Interface Electromagnetic compatibility Flow cytometer .fcs | FCS Flow cytometry file standard extension Forward scatter GMDN Global Medical Device Nomenclature HDMI High Definition Multimedia Interface Code (International Protection) max. -
Page 64: List Of Software Commands
12 Annex 12.2 List of software commands Context Command Effect Acquisition [Space] Clears displayed data Create Region Double-left-click Starts creation of a region Right-click Ends creation of a region Left-click Sets dot of a region Plot Left-click+ [Alt] Increased / decreased Plot Right-click + [Alt] Opens plot options Draws a rectangle to zoom into...