scienion sciREADER CL2 Product information sheet

sciREADER CL2
Original user manual
Hardware
EN

Original user manual
Type designation: CL2XN
Description: The user manual serves as a description of working with the
device sciREADER CL2 and software.
Software version: 1.6.50 and higher Document version: 1.4
Software: sciREADCL2 Last revision: July 25, 2019
!!!Keep for further use!!!
Before you start using the device, get familiar with user manual.
European Union:
Other Countries Research use only.
©Scienion AG, all rights reserved.
Manufaturer:
Scienion AG
Bussines ID No.: DE813228678
Registered office:
Volmerstr. 7b
12489 Berlin
Germany
Tel.:
+ 49(0)30-6392-1700 or
[phone]
Websites:
[email protected]
[email protected]
www.scienion.com
Scienion AG, 2019, Original user manual, sciREADER CL2 2

Contents
1. Introduction 4
1.1. Safetyandgeneralwarnings.................................. 5
1.2. Intendeduse .......................................... 6
1.3. Licenseagreement ....................................... 8
1.4. Warrantyconditions ...................................... 8
2. Description of the device and accessories 9
2.1. Checking the supplied components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
2.1.1. All-in-One PC IS included in the package . . . . . . . . . . . . . . . . . . . . . . 9
2.1.2. All-in-One PC is NOT included in the package . . . . . . . . . . . . . . . . . . . 10
2.2. Instructions for unpacking the sciREADER CL2 device .................. 10
2.3. Description of the main parts of the device . . . . . . . . . . . . . . . . . . . . . . . . . 11
2.3.1. Frontview ....................................... 11
2.3.2. Rearview........................................ 12
2.3.3. Microtiterplatetray.................................. 12
3. Hardware installation 14
4. First run 15
5. Device diagnostics, correct function check 16
5.1. Autodiagnostics......................................... 16
5.2. USBdiagnostics ........................................ 19
6. Care and Maintenance 20
6.1. Cleaning............................................. 21
6.2. Autodiagnostics......................................... 21
6.3. Preparing the device for shipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
6.3.1. The device is functional . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
6.3.2. The device is out of order . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
6.4. Device storage and handling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
7. Troubleshooting 24
7.1. Error states caused by improper use of the device . . . . . . . . . . . . . . . . . . . . . . 24
7.2. Hardwareerrormessages.................................... 24
7.3. Information for emergency situation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
8. Contact information 26
9. Technical specifications 27
10.Disposal 28
A. Decontamination Protocol 29
Scienion AG, 2019, Original user manual, sciREADER CL2 3

1. Introduction
sciREADER CL2 , sciREADCL2 and its specialized application modules are designed for the analysis of
images of microtiter plate wells in the standard 128 x 86 mm format (laboratory slides etc.), especially
for the analysis of the microblot array tests (multiplexes). As a component of the sciREADER CL2
device, the application modules ensure comfortable device control and the acquisition of high-quality
images.
Using sciREADCL2 , automated analysis, evaluation and archiving of completed tests can be performed.
This manual describes how to work with the sciREADER CL2 device. Here you will find the procedures
and instructions for working with the system.
Everyone who will use the device must become acquainted with the operating instructions. Before you
start to use the device sciREADER CL2 , carefully read the operating instructions for the device and
follow all the given instructions.
For following proper installation and using the software, read the user guide for work with
sciREADCL2.
Used symbols and icons
Please pay particular attention to notifications with these icons.
Icon Attention/Warning is used to alert or warn the user.
The Information/Note icon is used to alert the user to some important information.
Icon Error is used to alert the user to error conditions.
The Danger Icon is used to warn the user against the risk of accident.
The Alert icon is used to warn users against the risk of electric shock.
Labels and safety marks on the product
Please pay particular attention to labels placed on the device:
The Alert icon is used to warn users against the risk of electric shock.
The WEEE symbol, indicating separate collection for WEEE - Waste of electrical and
electronic equipment.
The CE mark.
Scienion AG, 2019, Original user manual, sciREADER CL2 4

1.1. Safety and general warnings
The user of this device is obliged to become familiar with this manual before starting to use
the device and is further obliged to proceed according to this manual.
If the device is used contrary to chapter 1.1 Safety and general warnings and the user does
not follow the instructions in this chapter, it may result in injury to the operator, damage to
the device, or the loss of warranty.
Terms of use
The device must be placed on a stable base, connected together with a PC, and for normal use the
following principles must be complied with:
The device can be used in indoor areas for environmental pollution degree 2, and only for the
purposes referred to in the instructions in 1 Introduction.
Protect the device from hits, falls, vibration and shakes.
Do not place samples, agents or any liquids on the surface of the device.
The normal temperature of the environment for using the device is 15 - 40
∘
C, at a maximum
relative humidity of 80%.
The minimum working space (without PC):
–Dimensions (width, height, depth) 250 x 230 x 430 mm.
–The minimum load capacity of the table is 25 kg (the weight of the device: 17 kg).
– The space in front of the doors must be free of any barriers that could prevent the ejection
of the tray.
– The air vents and the fan must remain clear, otherwise the service life of the product may
be significantly reduced. The ventilation openings are located on the sides of the device
(the distance from the surrounding barriers must not be less than 1 cm). The fan is located
in the rear part of the device (its distance from surrounding barriers must not be less than
10 cm).
The device can be used at transient overvoltage up to the category II overvoltage level and during
temporary overvoltage occurring in the power feed from the grid.
sciREADER CL2 device is designed in accordance with relevant legal regulation for electromagnetic
compatibility (EMC).
Only supported formats of input samples can be used - standard SBS microtiter plate format,
slide holder: 128 x 86 mm.
Samples must be handled according to the principles of handling of biological material and with
increased caution.
Use only original accessories provided by the manufacturer.
In case of any uncertainties during the use of the device, contact the service department or
support (see contacts below).
Attention
The device must be placed on a firm base.
Scienion AG, 2019, Original user manual, sciREADER CL2 5

The device cannot come into contact with liquids.
Do not switch on the device immediately after you bring it in from the cold into warmth - dew
may form on the device components. We recommend at least a 30-minute acclimatization.
Do not dismantle the device, except for dismantling the cover for access to the work area of the
device (more in section 6 Care and Maintenance).
Do not make interventions into the structure of the device.
Do not insert objects other than the dish of the supported format into the working area of the
device.
Do not use force on the accessible mechanical parts of the work space of the device.
Using any kind of tool or instrument to open the doors is not allowed. Do not open the doors
using force. Do not press down on the tray with force.
Do not open the doors and do not try to handle the dish tray with force during scanning.
Do not touch any other part of the device than those that are intended for this purpose.
Do not modify and do not interchange the cables endings.
Use the power cord and USB cable that were supplied with the device.
Do not remove the central grounding pin of the power cable under any circumstances.
Protect the cables against mechanical damage (bending, pinching), avoid inappropriate handling
of cables. Do not expose the cables to heat sources. In the case of power cable damage, stop
using the cable. Consult next steps with the staff of the Service Department.
Do not use the device in case of its damage. Contact the manufacturer and follow its recommendations.
It is not allowed to alter or modify the device or any of its parts in any way.
Servicing and repairs must be carried out only by personnel of the Service Department at Scienion
AG.
Contact service support
If the device is damaged, do not use it; contact the manufacturer and follow its recommendations.
Volmerstr. 7b
12489 Berlin
Germany
+ 49(0)30-6392-1700 or [phone]
[email protected]
[email protected]
www.scienion.com
e-mail: supp[email protected]
Residual risks
The device was subjected to risk analysis. Based on this analysis, device construction and design meet
current technical equirements.
Despite the correct usage of the device, and following all safety instructions, residual risks due to the
method of usage must also be considered.
Residual risks can be minimized by respecting all safety instructions given by this user manual.
1.2. Intended use
Scienion AG, 2019, Original user manual, sciREADER CL2 6

Intended use
The sciREADER CL2 is a device designed for the acquisition and processing of images of the wells of a
microtiter plate in the standard 128 x 86 mm format. It is primarily designed for the analysis of plates
with 96 wells, but also allows the analysis of plates with a different number of wells and further allows
use holder up to 4 slides.
Main application fields:
microbiology, immunology, serology;
research and development.
Because of the variability of the plate material (microtiter plate, slides etc.) and the types of analyses,
the device is equipped with several types of lighting:
Top lighting of the sample - non-transparent material.
Bottom lighting of the sample - transparent material.
In the manufacture and testing, the requirements of Directive 2006/42/EC, 2014/30/EU were applied.
The device is also intended for research and development purposes (RUO).
Missapplication
The user of this device is obliged to become familiar with this manual before starting to use
the device and is further obliged to proceed according to this manual.
If the device is used contrary to chapter 1.1 Safety and general warnings and the user does
not follow the instructions in this chapter, it may result in injury to the operator, damage to
the device, or the loss of warranty.
Preventive measures
Preventative measures will result in the elimination of residual risks, and minimise or eliminate problems
which could result from incorrect use of the sciREADER CL2.
Personnel using the device must have undergone training by a member of Scienion AG staff.
Training can be in the form of webinar or online training.
Only appropriately trained personnel are permitted to use the device.
We recommend the use of UPS (Uninterruptible Power Supply).
The device must be placed on a solid base with a minimum table load capacity of 25 kg.
In case of short–circuit, spontaneous ejection/insertion of the tray may occur, which could
result in the tray striking the user, squeezing the user by the door/tray.
Scienion AG, 2019, Original user manual, sciREADER CL2 7

In case of incorrect sample insertion, contamination of the device and its surroundings may
occur, which could have a detrimental impact on user’s health.
When handling biological material, use protective equipment.
Do not place barriers or obstacles in the area in front of the door of the device, and do not
insert any extraneous objects into the door space.
Do not insert any extraneous objects into the rack. Use only supported formats of input
samples.
Samples must always be deposited directly into the rack. For accurate placing of samples,
always use the locking elements fixed on the rack.
Do not make any alterations to, or interfere with, the device construction, and do not attempt
to manipulate the internal components of the device.
Removal of the cover is allowed only in cases of dish loosening or after device contamination.
The device must be disconnected from the power supply before manipulation.
In order to air convection, cooling and the ejection of the tray always ensure there is a space
of at least 10 – 15 cm around the device.
Incorrect choice of lighting can negatively impact the image appearance for analysis and
related diagnostics.
Failure of the user to pay proper care and attention can result in the image of the sample
being evaluated incorrectly.
1.3. License agreement
The license agreement is an integral component of the purchased version of the software product. At
the first run of the software, the responsible person is called upon to confirm the License Agreement. In
agreeing to the terms, the user agrees to be bound by all the provisions.
1.4. Warranty conditions
Damage to the equipment during unauthorized handling may lead to loss of warranty.
The rights and obligations of the seller regarding the guarantee liability shall be governed by generally
binding legal regulations.
Scienion AG, 2019, Original user manual, sciREADER CL2 8

2. Description of the device and accessories
The sciREADER CL2 device (Figure 1) is usually supplied according to the wishes of the customer as
an all-in-One PC in a similar configuration, as described in the chapter 9 Technical specifications or
without a PC.
Figure 1: The sciREADER CL2 device.
2.1. Checking the supplied components
Before putting the device into operation, please check the contents of the package according
to the check list below. In the event that any part is missing, or the device is damaged,
contact the Service Department of the manufacturer.
2.1.1. All-in-One PC IS included in the package
The installation of the software and the necessary drivers on the PC had been carried out by Scienion
AG employees before the product takeover.
Items on the Checklist:
sciREADER CL2 device
All-in-One PC, keyboard, mouse, power cable
The operating instructions are stored on a CD/DVD or a USB flash disk
Power supply cable with a plug for the EU (or possibly the US, Great Britain and others)
USB 3.0 A-B cable
Calibration plate - for verifying the correct functioning of the device
Allen wrench - for removing the locking screws
CD/DVD or USB flash drive
HW key for one software license
Quick start manual - printed
Acceptance instructions - printed
The appearance of a calibration template is shown in Figure 2.
Scienion AG, 2019, Original user manual, sciREADER CL2 9

Figure 2: The calibration plate.
2.1.2. All-in-One PC is NOT included in the package
If the All-in-One PC is NOT a part of the package, the PC used to control the device must satisfy the
configuration requirements listed in chapter 9 Technical specifications. By default, a CD/DVD or USB
flash disk is supplied that contains:
Installer of device drivers,
sciREADCL2 system with the relevant modules,
Electronic version of the manual in PDF format.
Items on the Checklist:
sciREADER CL2 Device
The operating instructions are stored on a CD/DVD or a USB flash disk
Power supply cable with a plug for the EU (or possibly the US, Great Britain and others)
USB 2.0 A-B cable
Calibration plate - for verifying the correct functioning of the device
Allen wrench - for removing the locking screws
CD/DVD nebo USB flash disk
HW key for one software license
Quick start manual - printed
Acceptance instructions - printed
2.2. Instructions for unpacking the sciREADER CL2 device
The device is supplied in a properly labelled container, which should not be damaged. Otherwise, consult
with the manufacturer about the damage.
Verify that damage to the packaging did not occur during transport.
Before using the sciREADER CL2 device for the first time, disengage the locking screws located on the
rear side of the unit (Figure 3):
1. Unscrew the transport locking screws using the supplied Allen wrench.
2. Keep the screws in a safe place for possible future transport of sciREADER CL2.
The tray is now unblocked, and the device is ready to use.
Scienion AG, 2019, Original user manual, sciREADER CL2 10

Figure 3: Procedure for unlocking the locking screws.
2.3. Description of the main parts of the device
Control elements
All device controls are accessible from the front and the back of the device; these are:
Switches
Buttons
Colour LED signalling
Other necessary controls:
Keyboard
Mouse
2.3.1. Front view
Accessible from the front view (Figure 4) are all the controls that are used to turn on the device, the
device status indication, and the control for the ejection of the tray.
Figure 4: Front view.
A Doors - close the work space of the device; the doors open/close by pressing the button for the
control of the doors or the action is invoked from within the software.
B Button to turn on the Power - the system initializes the hardware and software components.
C Button to control the doors Eject and controlling the eject/retract of the plate tray.
D LED indicator - used for information on the State of the device; the individual states are
distinguished by the color, light or blinking:
Scienion AG, 2019, Original user manual, sciREADER CL2 11

LED Device status
Unlit. The device is switched off.
Blinking red, orange, green. Initialization of the device.
Blinking orange. The device is switching on.
Glows orange. The device is ready for communication with BioVendor
Analytics application, but not connected to a PC.
Glows green. The device is connected to BioVendor Analytics
application and to a PC.
Switch between red and orange. The device is shutting off.
Glows red. Device error, malfunction. Contact the service
department.
2.3.2. Rear view
Located on the rear panel of the device connectors are the connectors and the main on/off switch of the
device (Figure 5):
Figure 5: Rear view.
A Power supply connector - for connection of power supply cable
B USB HOST connector - for connecting the flash disk designated for diagnosis
C LAN connector - for connection to the terminal of a service technician
D USB DEVICE connector - for the connection of the cable that connects the device nad PC
E Fan
F Power Main button - main on/off switch for the power supply to the device
2.3.3. Microtiter plate tray
Pressing the button on the front panel or clicking the button icon from the SW environment will open
the door and the microtiter plate tray will slide out (Figure 6).
For precise placement of the plate, locking elements are mounted on the tray. It is necessary to insert a
plate in one direction, with the written label of the plate row facing into the working area of the device.
Scienion AG, 2019, Original user manual, sciREADER CL2 12

Figure 6: The appearance of the tray, the direction of the insertion of the microtiter plate
or the slide holder.
Avoid such handling of the microtiter plate and tray that would lead to:
Incorrect insertion of the plate,
Disallowed tampering with the door of the device and the tray;
The bottom of the plate must sit smugly on the bottom of the tray.
Do not touch the plate tray as it slides in/out.
Please read the 1.1 Safety and general warnings chapter again.
Scienion AG, 2019, Original user manual, sciREADER CL2 13

3. Hardware installation
Do not plug or unplug the device from the power supply if the main switch is turned on.
Select a suitable work space for sciREADER CL2
Make sure that you have firmly fixed stands/anti-shock buffers on the bottom side of the
device.
Make the PC all-in-One or your own PC operational according to instructions
Make the sciREADER CL2 device operational
Assemble the equipment set as shown in Figure 7.
Figure 7: Procedure for connecting the device.
1. Connect the power cord to the device. The device is supplied with a standard power cord. The
connector for the power cord is accessible from the rear side of the device.
Do not touch the power cord with wet hands. Replace a worn or otherwise damaged cable
with an approved cable after consultation with the Service Department.
2. Connect the device and the PC with a USB cable. The connector for the USB cable is on the
rear side of the device.
Plug the USB cable allways into the USB port on PC with a symbol and/or USB 3.0
connector with blue insert .
The assembly is now complete, with all the components connected.
3. Plug the power cord into the wall outlet and turn on the main power switch Power Main located
on the rear side of the device right next to the power cord.
4. Press the Power ON/OFF button located on the front of the device.
5. The device is starting up, with the automatic initialization process being accompanied by the
blinking LED on the front side of the device.
6. If the device is connected to a PC by a USB cable, the company logo appears on the display, the
LED stops blinking and only glows steadily.
7. The device is ready for use.
Scienion AG, 2019, Original user manual, sciREADER CL2 14

4. First run
Before the first run of the sciREADER CL2 device and the sciREADCL2 system, please
read the following instructions in detail.
Make the All-in-One PC operational according to the instructions
Make the sciREADER CL2 device operational
Connect the power cord to the device and connect the device with the PC via the USB cable.
Plug the power cord into the wall outlet and turn on the main power switch Power Main located
on the rear side of the device right next to the power cord.
Press the Power ON/OFF button located on the front of the device.
The device starts up automatically, with the automatic initialization process being accompanied
by the blinking LED on the front side of the device.
If the device is connected to a PC by a USB cable, the LED stops blinking and only glows steadily.
The device is ready for use.
Run the sciREADCL2 system and the application module
First of all, attach the USB Flash Drive with hardware key (USB dongle) to your PC.
If the device is connected correctly, the LED stops blinking and only glows steadily.
The standard password for the ADMIN user is "admin".
Select the application module (tile) you want to use, and start the analysis.
Inserting samples into device
To eject the tray, press the Eject button on the front of the device (the tray can also be made
to eject from the software application environment).
Place the microtiter plate or the slide holder in the right direction in the tray. For correct
placement of the plate, locking elements are mounted on the feeder tray. It is necessary to insert
the plate in one direction, with the written label of the plate row facing into the working area of
the device (so that the A1 well would be at the far end of the plate to the user’s right).
To slide in the tray, press the Eject button on the front of the device (the tray can also be made
to slide in from the software application environment).
Turning off the system and the device
Ending the system - if you have the sciREADCL2 system and any of the application modules
running, press the cross in the upper right corner.
Turning off the device - by using the Eject button slide out the tray and remove the plate,
by using the Eject button again, slide in the tray again, to turn off the device, press the
Power ON/OFF button on the front of the device - the standard shutdown is performed with a
short press of the button.
Turning off the power supply to the device - turn off the Power Main main switch located on
the rear side of the device right next to the power cord.
Hard shutdown - use in cases where it is not possible to turn off the device in the standard
manner, using the button on the front side of the device. It is performed by holding down the
Power ON/OFF button for 15 seconds or by using the switch Power Main .
Scienion AG, 2019, Original user manual, sciREADER CL2 15

5. Device diagnostics, correct function check
5.1. Autodiagnostics
The sciREADER CL2 device is equipped with an autodiagnostic module. To verify that the device and
the software is functioning correctly, follow all given instructions.
Always perform diagnostic autotest after transporting the device.
For a basic check of the functioning of the device operation, perform an analysis of a Calibration plate.
Select Autodiagnostics autotest modul
Select the module by clicking the left mouse button on the tile Autodiagnostics
on the Application selection screen. Before confirmation of the selection, the
tile will become highlighted in color. To use this module, you must to be logged
in.
Inserting Calibration plate into device
Ejection/Retraction of tray
Pressing the button triggers the Ejection/Retraction of the
microtiter plate tray.
After ejecting the tray insert the plate into the lock template. After pressing the Eject button, the
tray will slide into the working area of the device (Figure 8).
Figure 8: The appearance of the screen - Device autotest.
Run the device autotest
Scienion AG, 2019, Original user manual, sciREADER CL2 16

The device must be connected to a PC.
First of all select the type of the test based on the material of microtiter plate:
Opaque plate test,
Transparent plate test.
For easy orientation, the left panel displays all the steps that the application takes during the auto-
diagnostic test:
Basic mechanics. System checks mechanical damage of moving parts.
Lighting. System checks all lighting types.
Tray (opaque/transparent plate). System checks mechanical damage of moving parts.
Plate recognition. System check the type of inserted plate - flat or elevated plate.
Flat plate Elevated plate
Figure 9: Plate types.
After plate recognition the next steps follow:
Camera and lighting (opaque/transparent plate). Testing lighting conditions.
Plate positioning (opaque/transparent plate). System check position of the control plate in the
tray.
Well reading (opaque/transparent plate). System checks functionality of wells licalisation.
Control of setting of top lighting system (opaque plate). Control of setting of top lighting system
(transparent plate).
Well reading (opaque/transparent plate). System checks functionality of wells licalisation.
Analysis (opaque/transparent plate). System performs qualitative and qualitative colony analysis.
Well reading, adjusted Z (opaque/transparent plate). System checks functionality of wells
licalisation.
Analysis, adjusted Z (opaque/transparent plate). System performs qualitative and qualitative
colony analysis.
Scienion AG, 2019, Original user manual, sciREADER CL2 17

Before making the exposure check, the warm-up phase of 10 minutes is run for each exposure.
(Figure 10).
Figure 10: Warming up and lighting check.
After pressing the button Old tests the record of already performed test is shown.
Pressing the button Run Autotest triggers the auto-diagnostic procedure.
While running the auto-diagnostic test, for each particular test description is shown in the right part of
the screen.
Successfully-performed test is indicated by a symbol next to the test name box. If a red cross appears,
the test has not been successful.
Status IS OK. Test was sucessfully completed.
Status is NOT OK. Test was not sucessfully completed.
Figure 11: The progress of the analysis of the Calibration plate.
Scienion AG, 2019, Original user manual, sciREADER CL2 18

Please follow all given instructions how to proceed further in the section Final
recommendation.
If a test failure occurs in any step while using the diagnostic software the procedure is stopped. The
current Test result and Final recommendation are shown.
In some particular cases user is obligated to contact the Service Department and consult next steps.
5.2. USB diagnostics
sciREADER CL2 device, on its’ rear part, is equipped with USB connector intended for USB diagnostics
of device or for a service access to device.
In case of the device can not be run after hardware installation, contact the manufacturer to
learn further procedure.
Scienion AG, 2019, Original user manual, sciREADER CL2 19

6. Care and Maintenance
The user is not permitted to perform servicing of the device. In case of damage, contact the Service
Department.
If the sciREADER CL2 device is handled according to the instructions, unexpected damage
should not occur.
Do not turn the device upside down; samples could fall into the workspace.
In the case that a sample falls into the workspace, immediately switch off the device. Take
off the user-servicing cover and remove the plate.
No further interventions in the device are permitted.
Procedure for taking off the user cover
Do not open the user-servicing cover if the device is turned on and the power cord plugged
into the wall outlet.
Unscrew the side screws on the device.
Take off the user-servicing cover (Figure 12).
After removing the user servicing cover, check whether seal stickers are placed on the sides; they should
not be damaged and be positioned at the specified places.
Verify the following locations of the seal stickers:
1. The sticker is located on the corner of the front side of the device.
2. The sticker is located on the corner of the back of the device.
Figure 12: Depiction of the procedure for the removal of the user servicing cover and the
location of the stamp cover stickers.
Damage to the equipment during unauthorized handling may lead to loss of warranty.
Scienion AG, 2019, Original user manual, sciREADER CL2 20