For Research Use Only. Not for use in diagnostic procedures.
CyFlow® Software Version 1.0 RUO
Doc. No.: CY-S-3068RIFUEN | Doc. Rev
.: 032 | 17-05-2018 | EN | CN 383
Imprint
Original Operating Manual
Sysmex Partec GmbH
Am Flugplatz 13
D-02828 Görlitz Germany
www.sysmex-partec.com
All rights reserved. No part of this manual may be reproduced, transcribed or translated in any form
or by any means electronic or otherwise, without the prior permission of Sysmex Partec GmbH.
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 medical 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 1–11,
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 6.5. This
chapter also is suitable to get to know the functioning of your device.
In the second part, chapter 12, 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 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.
In this operating manual, warnings are indicated by a signal word. Hazards
are categorised into hazard levels with consequences of differing severity.
Type of hazard
This will result in death or have a serious impact on health.
Information about avoiding the hazard.
1Introduction
Type of hazard
This could result in death or have a serious impact on health.
Information about avoiding the hazard.
Type of hazard
This may have a minor impact on health.
Information about avoiding the hazard.
Type of hazard
This could result in material damage.
Information about avoiding the hazard.
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.
For Research Use Only. Not for use in diagnostic procedures.
The device is a flow cytometer, it offers automation for routine use and
flexibility for research use in the field of flow cytometric applications.
The applications cover:
Multi-colour analysis of immune cells for research purposes;
Leukocyte counting/rare event analysis for research purposes;
Microbiological analysis;
Fermentation control;
Bead-based assays for research purposes;
Particle and cell concentration analysis based on True Volumetric
Absolute Counting;
Particle size and fluorescence distribution analysis.
2.2 Prohibited use
Never use the device with organic solvents as this can destroy the fluidic
system. Only use particles with a diameter < 100 µm. Only use Sysmex
approved fluids for sheath, cleaning and decontamination.
Never for use in diagnostic procedures.
2.3 Reasonably foreseeable misuse
Only use this device as a sensitive measuring device. It should:
NOT be used as personal computer.
NOT be used with chemicals harmful to the device (household sanitisers
The device may only be used by personnel properly instructed in its
handling. The manufacturer, authorised distributor or a person authorised by
the operator (and trained by either the manufacturer or an authorised
distributor) must provide instruction in handling the device with the help of
this operating manual.
The device is aimed for a large spectrum of users, from beginners to
experts. In the best case an expert is around – so, if you are a beginner, let
her/him help you.
Access to the device is not permitted to insufficiently qualified personnel.
2.4.1 User qualification groups
Instructed personnel
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.
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.
Authorised service personnel
Personnel conducting technical service must be authorised by Sysmex.
Please contact the service department of your local Sysmex representative.
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 60825-1:2015).
Never 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 of laser light of laser class IIIb.
2.9 Electrical safety
The main electrical source used must be grounded or earthed due to local
specifications.
2 Safety
Please place the device in such a way that the electrical power cord can
easily be unplugged. Removable power cords should not be replaced by
inadequate wiring.
Beware of possible voltage when changing the fuse (T 4.0 A 250 V).
2.10 Alterations to the device
Unauthorised alterations to the device can result in risks and hazards.
Therefore, unless expressly permitted by the manufacturer, no alterations
may be made to the device.
If the device is altered, appropriate tests and trials must be performed to
ensure the continued safe use of the device.
Your CyFlow® Cube device is a fully equipped desktop Flow Cytometer
(FCM). Which features a modular optical concept. This allows different
lasers with different wavelength ranges be used as light sources and the
detection of up to 8 optical channels (parameters).
The device allows the optics to be optimised for any application simply by
exchanging optical filters and mirrors. The device runs with an internal PC.
Data acquisition, device control, and data analysis are controlled and
performed by the software.
Fig. 3.1 Front and left side of the device
14CyFlow
1 On switch
2 Sample port
3 Ports for external devices
The device contains the flow cuvette, the optics, the fluidics, the computer
unit and data acquisition electronics. No work steps inside the device are
necessary.
The main components of the device are:
Control elements
The device is operated via keyboard and mouse. The On switch is located
on the top, when the display of the device is lifted up. The power switch is
located on the rear side of the device.
Computer interface ports
The computer interface ports connect the device with additional optional
electronic devices. They are located on the left side of the device.
3Overview
Sheath fluid bottle and waste bottle
The sheath fluid transports the sample flow during the measurement.
The connecting ports for the tubings of the sheath fluid bottle and waste
bottle are located inside the device. The tubings are preinstalled. The sheath
fluid bottle and waste bottle are located in the sliding compartment at the
rear side of the device.
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 exact 200 μL volume for each sample. The method of True Volumetric
Absolute Counting (TVAC) supported by CyFlow
the precise measurement of a fixed sample volume.
The type plate is attached to the rear side of the device.
The content of the type plate varies according to the system configuration.
The system configuration is represented by an addition to the REF number
(e.g. CY-S-3068R_N1).
The following signs are part of the type plate which has been affixed to the device.
SymbolMeaning
RUO
For Research Use Only
Manufacturer
Certification mark
Reference Number
Serial Number
Manufacturing date
Waste of Electrical and Electronic Equipment
Operating manual
Indicates the temperature limits to which the device can be
safely exposed
No direct sunlight at the installation location
Indicates the range of relative humidity to which the device
can be safely exposed
Always have at least two people carry or lift the device.
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. Place the device in the
packaging for transport and storage.
The storage environment must be dry, clean and dust-free:
Storage temperature: between 5 °C and 50 °C;
Relative humidity: between 20 % and 85 %, non-condensing.
When moving the device (packed or unpacked) or removing it from its
packaging, a person is exposed to a high risk of damaging his or her body
due to the heavy weight of the device.
At least two persons are required for transport and installation.
Carefully select the place where to position and operate the device. Comply
with the following criteria when positioning the device:
5 Installation
Place the device on a solid, dry and clean horizontal surface.
Avoid smoke, dust, vibrations, direct sunlight and any source of direct
heat.
Leave a minimum distance of 15 cm between the back of the device and
a wall to keep the ventilation effective.
Do not block the ventilation grid at the back of the device.
Do not place any objects on the device.
5.2 Installation and uninstallation
Installation, connection, disconnection and uninstallation may only be
performed by authorised service personnel and in conformity with the
applicable national rules and regulations.
Due to heavy use of software-related content in the following chapter please
also refer to chapter 12 Software description on page 50.
6.1 Inserting the Software dongle
Procedure
1. Insert the included Software dongle into an open USB port of the device.
Result
The software will check automatically in regular intervals if the dongle is
plugged in. If the dongle is not plugged in, the software will not be
functional.
6.2 Start-up procedure
Old sheath fluid
Old sheath fluid affects the sample flow through the flow cuvette.
Replace the sheath fluid at least once a week or before any daily use.
6.2.1 Switching on the device
Before switching on the device make sure the sheath fluid bottle is filled with
800 ml of clean, filtered and degassed sheath fluid and is closed with the
blue screw cap. It is recommended to replace the sheath fluid at least once a
week or before any daily use.
Requirements
The sheath fluid bottle is filled and connected to the device.
The waste bottle is empty and connected to the device.
Procedure
1. Switch on the device using the power switch on the rear side of the
device.
4. Start the software by double click the CyFlow® Software icon.
– The log-in dialogue is displayed.
– The device is, by default, set in a standard mode.
6.2.2 Logging in and logging out
Each user is assigned to a user role. Each user role has specific privileges.
Some functions of the software are not available for each user role and
availability depends on the assigned privileges.
User management
RolePrivileges
Service operatorUser administration
6Operation
Worklist creation
Logging in
Worklist management
Sample analysis
Manage Workspace and settings
Create comp setup
User administratorUser administration
Parameter properties
Assay developerManage Workspace and settings
Worklist creation
Worklist management
Sample analysis
Create comp setup
Requirements
The log-in dialogue is displayed.
User access must be set up and the user name and password must be
– If the log-in was successful the start screen is displayed.
After a specified number of unsuccessful login attempts (default 3), the
account will be locked. If the account is locked, please contact a user with
the "user administration" privilege in its user role, e. g. a user administrator.
The default settings for logins can be changed in the user management.
Procedure
1. On the File tab of the Ribbon (see chapter 12.4.1 File tab on page 58)
click the Log-out button.
– The current user is logged out.
– The log-in dialogue is displayed.
6.2.3 Performing a Prime
A Prime mode is available as a start-up process for the device. This process
includes cleaning, filling the tubes with sheath fluid and controlling the device
set-up.
The Prime should be performed in the following cases:
Starting the device for the first time of the day,
After the sheath fluid bottle has been filled,
As a trouble-shooting procedure (no/bad signals, blocking, etc.).
Requirements
Sample tube with 1.6 ml Decontamination Solution (Order No.
04-4010_R) connected.
Procedure
1. On the Cytometer tab of the Ribbon (see chapter 12.4.10 Cytometer tab
on page 105) or on the Acquire pane (see chapter 12.5.4 Acquire pane
on page 140) click the Prime button.
– The instruction dialogue for the Prime procedure is displayed.
2. Follow the instructions until the finish message is displayed.
– The device is ready for the sample measurements.