R-Biopharm RIDA qLine autoBlot User manual

User Manual
RIDA qLine®autoBlot
https://clinical.r-biopharm.com

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RIDA qLine® autoBlot | User manual

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User manual
RIDA qLine® autoBlot
REF ZG3101:
Version 2.00 (2022-03-30)
Pegasus Revision 1.6.1
© Copyright 2022 by R-Biopharm AG
R-Biopharm AG reserves the right to
modify its products and services at any
time. This guide is subject to change
without notice. Although prepared to
ensure accuracy, R-Biopharm AG assumes
no liability for errors or omissions, or
for any damages resulting from the
application or use of this information.
The content of this manual is the property
of R-Biopharm AG and is copyrighted.
Except as specified in the End User License
Agreement, any reproduction in whole or
in part is strictly prohibited.
© 2022 R-Biopharm AG, Darmstadt,
Germany
R-Biopharm AG
An der neuen Bergstraße 17
64297 Darmstadt, Germany
+49 (0) 61 51 - 8102-0
+49 (0) 61 51 - 8102-40
[e-mail]
www.r-biopharm.com

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RIDA qLine® autoBlot | User manual
Inhalt
1 Introduction 6
1.1 Intended purpose 6
1.2 Purpose oft the document 6
2 Product Overview 7
2.1 Glossary 9
3 Technical Specications 9
4 Safety & General
Information 10
4.1 Unpacking and installation 10
4.2 Accessories provided
with the instrument 11
4.3 Consumables required but not
provided with the instrument 13
4.4 Instrument labeling 14
4.5 Detailed Personal Safety
Information 14
4.6 Environmental Conditions 15
4.6.1 Bench Space 15
4.6.2 Disconnection guidelines 15
4.6.3 Ventilation 15
4.6.4 General 16
4.7 Initial Setup 16
4.7.1 Lubricate (grease)
the Probe O-Ring 17
4.7.2 Mount and Connect
the Touchscreen 17
4.7.3 Powering the Instrument 19
4.7.4 System Start-up
and Initialisation Check 19
4.7.5 Critical Errors 21
5 System Overview 22
5.1 AutoBlot Component Guide 22
5.2 Installation of Accessories 22
6 System Operation 24
6.1 The System Menu 25
6.1.1 Information Tab 25
6.1.2 Logging Tab 26
6.1.3 Installed Scripts Tab 27
6.1.4 Installed Firmware Tab 27
6.2 Determining the IP address
of the instrument 28
6.2.1 Pre-requisites 28
6.2.2 Activating Engineering 28
6.2.3 Viewing the Internet
Protocol (IP) address 29
6.3 Connecting to the instrument
to RIDA qLine® Soft 30
6.3.1 Device settings for
RIDA qLine® Soft 31
6.3.2 Full automatic processing 32
7 Assay processing 33
7.1 Creating a Worklist 33
7.2 Running a Work-list 34
7.3 Transfer Exception Handling 38

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7.4 Obtaining Work-list
Information Directly from
the Instrument 41
7.5 Standalone Imaging 42
7.6. Accessing Stored Images 42
8 Automated Cleaning
Routine 43
9 QC test using
RIDA qLine® Soft 45
10 Instrument Shutdown 47
11 Troubleshooting 49
11.1 Simple Troubleshooting 49
11.1.1 Visual Inspection 49
11.1.2 Mechanics 50
11.1.3 Fluidics 50
11.1.4 Initialisation 50
11.1.5 Critical Error Messages 51
12 Cleaning the Instrument 51
13 Disposal 52
14 Corrective action/
Notication
to authorities 53
15 Technical Support 53
16 Conformity
IEC 61326-2-6
and RoHS3 53
17 Limited Warranty 54
18 Version Number 55
19 Appendix 55
19.1 Appendix II: Synopsis
of Symbols used in
manual & on instrument 55
19.2 Touchscreen Icons 57
19.3 Appendix III -
Cyber Security Statements 58
19.4 Appendix IV - RIDA qLine®
autoBlot-INSTALLATION
CHECKLIST 60
19.5 Appendix V - RIDA qLine®
autoBlot - DECONTAMINATION
CERTIFICATE 63
19.6 Assay protocol 65

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RIDA qLine® autoBlot | User manual
It is important to read this manual before using the instrument
Please read this manual carefully before using the instrument and make it
accessible to all users. Failure to comply with the instructions in this manual
will void the manufacturer’s warranty and may pose a risk to the user.
Ensure all users are conversant with the instrument - contact R-Biopharm AG
for any further instrument or training requirements if in any doubt before
using the instrument.
Consult User Manual where symbol (left) is seen on the instrument
1 Introduction
1.1 Intended purpose
For in-vitro Diagnostics. The RIDA qLine® autoBlot is a fully automated Analyzer for the
processing RIDA qLine® Allergy tests. The RIDA qLine® autoBlot may only be used in
combination with RIDA qLine® Allergy tests that are approved for processing and analysis.
The RIDA qLine® autoBlot must be used in combination with the RIDA qLine® Soft
software. The product is intended for professional use.
1.2 Purpose oft the document
The purpose of this document is to provide end-users with a complete overview of the
RIDA qLine® autoBlot (henceforth named as “autoBlot”) instrument, to such an extent that
once the document has been read, the reader will have an understanding of what the
instrument does and how it can be operated to fully utilise its potential.

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2 Product Overview
The AutoBlot Processor is an instrument which supports 3 dimensional robotic movement
on the X, Y and Z axes. It’s comprised of a built-in Charge-Coupled Device (CCD) scanner,
a barcode reader and a pressure sensor. Also built in to the instrument is a bespoke tilting
and orbital shaker mechanism for agitating the strips used on the instrument. The unit as
a whole is controlled via an integrated touchscreen which is running a bespoke software
controller and graphical user interface. The combination of all these features result in the
ability to completely automate the processing of R-Biopharm RIDA qLine® Allergy for
detection of specic IgE in allergy diagnostic.
Starting from sample handling and ending with images of the panels once processing has
completed.
The instrument is designed to be partnered with RIDA qLine® Soft for the band inter-
pretation of RIDA qLine® Allergy tests used on a standalone computer which resides
somewhere on the same network as the instrument. By creating work-lists and passing
them along to the instrument, the software can track the progress of a work-list and
nally interpret the results when the scanning has completed.

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RIDA qLine® autoBlot | User manual
The typical work-ow of the instrument would go as follows:
i. A user sends 1 or more work-list from RIDA qLine® Soft to the instrument.
ii. The user walks over to the instrument and selects a work-list they wish to process.
Following onscreen instructions, the user is told how to prepare the instrument.
iii. When the instrument has been loaded as requested, a panel pre-scan will begin.
This scan ensures that the correct number of test kit panels are inserted, in the
correct order. This process works by detecting the colour of each panel.
iv. When the pre-scan has veried the correctness of the panels, the sample tube veri-
cation begins. This is a process of ensuring all the correct sample tubes are loaded
into the carousel. This is done by comparing detected barcodes with the ones specied
in the work-list.
v. When the correctness of the samples have been veried, the actual processing protocol
is triggered. The protocol includes the prewashing of the membranes, the transferring
of samples from the carousel to the panels, and the continued processing of the
panels, including the dispensing and aspiration of reagents using precision piston
pumps. All samples and reagents are transferred using disposable plastic tips. All
reagents are provided as part of a kit.
vi. Once the assay has been completed, the image scanning will automatically begin to
capture an image of every panel. These images are saved on the instrument and are
made available to RIDA qLine® Soft.
vii. An optional, but recommended last step, would be to run an automated cleaning
routine with the instrument.

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2.1 Glossary
Definitions Meaning
autoBlot The name of the instrument that this document is discussing.
Instrument Synonymous with “autoBlot”.
User The person who is using the autoBlot in its standard operation.
Operator Synonymous with “User”.
3 Technical Specications
Instrument type: Standalone bench top
Processing Capability: 1 to 36 samples per run
Processing Time: Typically 3.5 hours for 36 samples
Temperature Control: PID under software control
Processing Volumes: 10 mL to 1000 mL
Minimum required
sample volume:
1000 mL
Dispensing Mode &
Accuracy:
Piston Pump: +0/-5 %
Peristaltic pumps: +0/-10 %
Software: Pegasus software
Voltage & Frequency: Electrical power source at AC 100 to 240 V AC 10A
50/60Hz
Fuses: 5A UL Approved – Ø5x20mm
Dimensions: 600(H) x 620(D) x 780(W) mm
Weight: 65 kg

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RIDA qLine® autoBlot | User manual
Consumption value
(energy):
150 W (max)
Acoustic noise level (dB): ~ 60 dB
Electromagnetic emissions: Class A 30 MHz to 1000 MHz
Radiated field immunity: 10 V/m 80 MHz to 1000 MHz
3V/m 1.4 GHz to 2 GHz
1V/m 2 GHz to 2.7 GHz
4 Safety & General Information
4.1 Unpacking and installation
CAUTION: HEAVY INSTRUMENT
The instrument itself weighs 65 kg and the whole unopened container may
weigh as much as 95 kg. AT LEAST two able bodied persons are required to
move the instrument from the container.
1. Upon receipt of the instrument, visually inspect the container for any transit damage.
Any damage should be recorded prior to opening.
2. Ensure that the wooden container is placed in an upright position before attempting to
open.
3. As the container may have sharp edges, it is highly recommended that appropriate
gloves be worn for unpacking.
4. Remove the outer straps and lift off the main cover. When open, remove all accessories
from the container. Lift the wooden outer shell upwards and place to one side.
5. To lift the instrument off the base, AT LEAST two able-bodied persons are required.
One person should be positioned at the front of the instrument, and another should

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be positioned at the back of the instrument. To remove the foam side cheek, lift one
side of the instrument and have a third person remove it from the raised side. Gently
lower the instrument back down and repeat this for the other side. Remove any
protective bubble wrap and the foam top protectors that remain.
6. Remove accessory box from inside of the instrument, and remove all drive
securing apes.
7. Remove the X Rail Transit Clamp.
8. The outer shell can be collapsed at and placed onto the base of the packaging and
the lid replaced over it.
9. Inspect the instrument for any obvious signs of transit damage. Report any damage
immediately to your local representative.
10. Check that the serial number on the instrument and the delivery note are the same.
11. Unpack accessory box and check that all accessories are present. The full list of
accessories are listed in the table below.
4.2 Accessories provided with the instrument
Accessory Box A
Item Description Quantity
1 Wash Bottle Holder 1
2 Waste Bottle Holder 1
3 Wash Bottle & Lid 1
4 Waste Bottle & Lid 1
5 Reagent Bottle Holder 1

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RIDA qLine® autoBlot | User manual
6 Priming Trough 1
7 Tip Rack Holder 1
8 Touchscreen Screws & Keys 1
9 5A Fuse 2
10 Instrument Mains Lead 1
11 Ethernet Cable 1
12 Spare Packing Tape Set 1
Accessory Box B
Item Description Quantity
13 1000 mL spare Nalgene Rect. Bottle*
*Labelled “A. bidest”
1
14 Touchscreen, Mounting Arm, Cables 1
15 Waste Tip Trough 1
16 Tray (Strip Holder) 1
17 Sample Carousel 1
Software
Product Art. No.
RIDA qLine® Soft Z9995
Store all packing materials until completely satised that the instrument was delivered
safely and that it is performing to specication.

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4.3 Consumables required but not provided
with the instrument
Consumables in addition to the RIDA qLine® Allergy tests are the disposable plastic tips
(Tecan Genesis Compatible, 1000 μL non-ltered, non-sterile, clear tips. The instrument
has been designed for use with a specic type of tip, ones which will be provided by the
distributor. No attempt should be made to try and use other forms of plastic tips. Failure
to adhere to this advice may result in the failure of the instrument and will void any
warranties provided.
The Carousel uses Sample Tubes which sizes range between:
Height: 75 - 102 mm
Diameter: 12 - 17 mm
The supplied RIDA qLine® Allergy reagents must be transferred into the glass bottles for
the autoBlot before use. The tips and glass bottles for the reagents can be directly ordered
from R-Biopharm, as well as the corresponding screw caps.
Product Art. No.
RIDA qLine® Allergy A6442, A6242, A6342, A6142, A6142EC2, A6142VIET,
A6142PSMI, A6442UA1, A6242H, A6242PA,
A6342UY, A6142UZ, A6442TZA, A6342MENA,
A6442UZ, A6442BY, A6342KE, A6342BY,
A6142HVEN, A6142UY, A6442UA2, A6242GR,
A6342PH, A6242PH, A6142BY, A6242BY, A6242UY,
A6142ZW2, A6142EAWU, A6242EAWU, A6342EAWU,
A6442EAWU, AW2001, AW2002, AW2003, AW2004
RIDA qLine® autoBlot Screw
cap bottle 20 mL
Z0 011
RIDA qLine® autoBlot Screw
cap for Z0011
Z0012
RIDA qLine® autoBlot Pipet tips Z0 013
RIDA qLine® QC-Kit (for RIDA
qLine® Soft)
ZG1108

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RIDA qLine® autoBlot | User manual
4.4 Instrument labeling
Please observe and respect all caution labels shown on instrument & consumables:
4.5 Detailed Personal Safety Information
Symbol Description
Warning!
Avoid touching the instrument with wet hands, and do not attempt to
disassemble the instrument. In either case electrical shock may result,
and in both cases the warranty will be invalidated.
Warning!
The instrument will automatically stop when the Cover is opened. Never
attempt to manipulate or run the instrument with the Cover opened.
Warning!
It is recommended to wear eye protection, a laboratory coat and
protective gloves when operating the instrument / handling reagents.
If contact of any reagent occurs with skin or eyes, wash thoroughly
with water.

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4.6 Environmental Conditions
4.6.1 Bench Space
Always place the instrument on a at and solid surface while ensuring that there are no
obstruction to the Touch Screen on the right-hand side of the instrument. The minimum
bench space that required is a width of 1000 mm and a depth of 700 mm - The depth
constraint is required to ensure there is no overhang on the front of the instrument.
The instrument should be placed no further than 1 meter away from an appropriate
power source.
The door to the instrument swings upwards. When fully raised, the height from the base
of the instrument to the extreme of the door is 1000 mm. Ensure the allocated bench
location accounts for this.
4.6.2 Disconnection guidelines
In an emergency immediately turn the power off and unplug from power source.
The mains switch and mains lead connection is located on the right hand side panel of the
instrument. Do not place the instrument too close to any object that might impair
emergency disconnection in an emergency, particularly any object to the right side panel
of the instrument.
4.6.3 Ventilation
The instrument should not be placed in line with a direct draft (such as an air vent) and a
clearance of 100 mm should be afforded from any other obstruction (e.g. walls or other
instruments).

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RIDA qLine® autoBlot | User manual
4.6.4 General
The instrument should be kept free of dust, harsh solvents and acidic vapours. The
instrument should not be exposed to vibrations, harsh sunlight or unduly large variations
in temperature and humidity. Failure to abide could affect the correctness of the result.
The instrument is designed and intended for in-door use only: located on a at surface
within a typical laboratory environment, i.e.:
Altitude: Up to 2000 m
Temperature: Ambient temperature range: Between 5 - 40 ºC
Humidity: Maximum relative humidity 80 % for temperatures up to 31 °C
decreasing linearly to 50 % relative humidity at 40 °C
Mains voltage: 100 to 240 V – 10A 50/60Hz & fluctuations of up to ± 10 %
in supply
Storage conditions: from 5 ºC to 50 ºC
It’s advised to let the instrument to stand for 3 hours before applying power to avoid
problems that might arise from condensation.
4.7 Initial Setup
Once the instrument has been unpacked according to the statements in section 4.1, and
placed on suitable bench as described in section 4.6.1, the initial set-up steps can be
started.

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4.7.1 Lubricate (grease) the Probe
O-Ring
Apply a small amount (approx 1mm ‘blob’) of
silicone grease to the o-ring - illustrated in Figure 1.
Place a 1000 mL tip onto the tip-picking probe, rotate
the tip on the probe twice over in order to spread the
grease over the whole o-ring, then remove the tip.
Thoroughly wipe the metal parts of the probes
(and not the o-rings) clean with tissue, so that there
is no grease left on the probes themselves.
4.7.2 Mount and Connect the Touchscreen
Figure 1: probe o-ring
Figure 2: touchscreen rear clamp
mounting
Figure 3: touchscreen-to-instrument
mounting

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RIDA qLine® autoBlot | User manual
To attach the support arm, and thus the touch screen to the instrument, 4 screws,
3 washers and two Allen keys must be retrieved from the accessory collection.
Using the longest M6x75 screw from the screw set (and appropriate M6 washer), secure
the Touchscreen rear clamp to the arm. This is illustrated within the yellow circle in Figure
2. On the opposite side, locate the smallest M4 screw in position in order to limit the tilt
movement of the Touchscreen.
It is recommended to obtain help from an assistant at this stage.
Maneuver the arm onto the bracket at the side of the instrument, ensure that the screen is
aligned correctly, then tightly clamp the bracket by using the remaining 2x M5 screws
(and appropriate M5 washers) provided in the screw set. This is illustrated within the red
circle in Figure 3. Ensure that the screen cannot move after clamping.
For anything to appear on the touch-screen, the DVI cable of the touch-screen must
be attached to the 25way connector at the side of the instrument. This connection is
illustrated within the top-most blue circle in Figure 3.
For touch-support to be enabled, the USB cable of the touch-screen must be attached to
a USB port on the instrument’s on-board computer. This connection is illustrated within
the central green circle in Figure 3.
Once all of the above has been completed, connect the power supply to the touch-screen.

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4.7.3 Powering the Instrument
To power on the instrument, insert a mains lead
into the side of the instrument while the switch state
is set to off (as denoted by the marker) as shown
in Figure 4.
Note that the instrument must be powered by
an earthed mains supply, and it is recommended
to power the instrument through an appropriate
RCD device.
Once the cable has been connected on both ends,
press the power switch until the icon is down.
Completing the former steps should have now
resulted in the instrument being turned on.
4.7.4 System Start-up and Initialisation Check
Once the instrument has been powered and the on-board computer has loaded up, the
main software application should automatically launch and begin an initialisation task.
This is a task which happens every start-up to ensure that all the core components are
fully functional and ready for use.
During the initialisation check, the instrument will move the drives to ensure everything is
okay. For this movement to start and complete, ensure the door is closed throughout the
initialisation process. The movement that should be witnessed goes as follows:
1. The Z axis will move to the home position; this consists of raising up if lowered.
2. The Y axis will move to its home position; this consists moving to the back of the
instrument.
Figure 4: The mains lead
attached to the power inlet
socket of the instrument

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RIDA qLine® autoBlot | User manual
3. The X axis will move to its home position; this consists of moving to the left hand side.
4. The carousel drive will rotate to its home position; this consists of ensuring position
1 is infront of the barcode reader.
5. The tray table will move to its home position; this consists of tilting the table.
6. The X and Y arm will move out to the tip waste trough, where the Z will perform
an eject action, followed by a return home by all axes.
If the above is successful, the master
controller checks will be ticked off and
followed by quick camera and barcode
reader checks. If all are successful, the
screen should resemble what is shown
in Figure 5. At this point, the application
can be entered by pressing start.
If anything goes wrong during initialisation,
a cross will be put next to the component
being initialised and a message will be
shown telling the user to contact technical
support. If anything goes wrong here
during the rst time set-up, please contact
your service provider.
An example of a failure screen is shown
in Figure 6. Note you will not be allowed
to enter the main application if any errors
occur.
Figure 5: The interface that is shown after
a fully successful instrument initialisation
routine
Figure 6: The interface that is shown when
there are failures in the initialization routine