TM
EVOLIS Twin Plus System
User Manual
REF
93502-m-EN
LOT
V1.00 – 0805
Revision of the manual: May 2008 – English
Software version: 1.00
IVD
We reserve the right to make changes in the course of technical development without prior
notice.
Copyright - Software
The software for the EVOLISTM Twin Plus analyzer has been licensed
to Bio-Rad for worldwide distribution. The EVOLISTM Twin Plus
software is the intellectual property of STRATEC Biomedical Systems
AG. Intellectual property rights shall remain with STRATEC
Biomedical Systems AG.
You are entitled to use the EVOLISTM Twin Plus software at your
place of work only.
Any violations of property rights or copyright or trademark may be
subject to legal action.
MicrosoftTM and WindowsTM are registered trademarks of Microsoft
Corporation.
Copyright - User manual
This manual is the copyright of Bio-Rad Laboratories and must not
be copied or reproduced in any form without prior consent.
Bio-Rad
3, boulevard Raymond Poincaré - B.P. 3
92430 Marnes-la-Coquette - France
Phone: +33 (0)1 47 95 60 00
Fax: +33 (0)1 47 41 91 33
Table of Contents
EVOLIS Twin Plus Version 1.00 – User Manual
Table of Contents
About This Manual............................................................................................... V
Bio-Rad Technical Support.................................................................................. V
Typographical Conventions ................................................................................ VI
Safety Instructions ............................................................................................. VII
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1
System Overview.............................................................9
1.1
Instrument Description.......................................................................9
1.2
Software Overview ............................................................................11
2
Daily Routine Operation................................................13
2.1
2.1.1
2.1.2
Getting Started ..................................................................................13
Check Liquid Levels (Start-Up Maintenance) .....................................13
Start-Up ...............................................................................................14
2.2
Prepare and Load Samples ..............................................................16
2.3
Check and Validate the Worklist .....................................................18
2.4
2.4.1
2.4.2
2.4.3
2.4.4
2.4.5
Complete the Loading Process .......................................................22
Wash Solutions and Rinse Fluid .........................................................23
Dilution Plates (if any) .........................................................................23
Pipetting Tips ......................................................................................24
Reagents .............................................................................................25
Test Plates ..........................................................................................26
2.5
Run .....................................................................................................28
2.6
2.6.1
2.6.2
Run Results .......................................................................................29
Understanding / Validating Result Reports .........................................30
Export Results .....................................................................................32
2.7
2.7.1
2.7.2
End of Run .........................................................................................33
Unload / End of Run Maintenance ......................................................33
Shutdown / End of Day Maintenance..................................................34
3
Advanced Information...................................................35
3.1
Assays................................................................................................36
3.2
Barcodes ............................................................................................38
3.3
Samples..............................................................................................40
3.4
Reagents and Controls.....................................................................41
3.5
Non Bio-Rad Kits...............................................................................46
3.6
Dilution Plates and Diluents.............................................................47
3.7
Pipetting Tips ....................................................................................48
3.8
Logs....................................................................................................49
3.9
Schedule ............................................................................................51
3.10
Multi-Assay per Plate........................................................................52
III
Table of Contents
EVOLIS Twin Plus Version 1.00 – User Manual
IV
3.11
Pipetting Errors .................................................................................54
3.12
Pausing a Run / Emergency Stop....................................................56
3.13
Continuous Loading .........................................................................57
3.14
Flags ...................................................................................................59
3.15
Recalculate Results ..........................................................................61
3.16
Import .................................................................................................63
3.17
Export .................................................................................................65
3.18
Users Rights and Passwords...........................................................66
3.19
Demo Mode and Connections..........................................................68
3.20
General Maintenance Tasks and Maintenance Schedule .............69
4
Troubleshooting ............................................................75
A.
Appendices ....................................................................81
A 1.
Technical Specifications ..................................................................82
A 2.
Accessories and Consumables .......................................................84
A 3.
Data Label ..........................................................................................87
A 4.
Symbols and Abbreviations.............................................................88
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About This Manual
EVOLIS Twin Plus Version 1.00 – User Manual
About This Manual
Important Notice
This manual contains all information needed:
•
to operate the EVOLIS Twin Plus system on a daily basis with Bio-Rad
predefined assays,
•
and to perform regular maintenance routines.
All first-time users should have read this manual carefully before operating
the EVOLIS Twin Plus system.
Installation, configuration and servicing of the system can be performed by
Bio-Rad authorized personnel only and are not described in this manual.
Advanced functions (e.g. assay programming, sample archiving) that require
specific training are also not described in this manual.
Users must not perform any operation not described in this manual.
If in doubt, please contact Bio-Rad Technical Support before performing the
intended operation.
Bio-Rad Technical Support
Worldwide technical support for Bio-Rad products is available on the Web
at: http://www.consult.bio-rad.com
For information on how to contact directly your local Bio-Rad representative
or service engineer, please visit also the above website and select your
country.
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V
Typographical Conventions
EVOLIS Twin Plus Version 1.00 – User Manual
Typographical Conventions
Warning messages are indicated by this symbol and printed in boldface italics. Non compliance with these instructions may result in the
operator getting hurt or contracting an infection, or the instrument
being damaged.
Notes are indicated by this symbol and printed in bold-face type. Non
compliance with these recommendations may result in the test results
being invalidated or unreliable results or having to abort a run.
Menus
Are printed in bold-face type.
Example: Select the File menu.
Menu items
Are printed in bold-face type, separated from the menu by a vertical line.
Example: select the File | New menu item.
Buttons/Icons
Are printed in bold-face type with < > signs.
Example: Click the <Open> button.
(numbered lists) 1.
Identify sequences of actions to be performed by the operator.
Software messages
Are printed in italics when quoted in the general text.
Example: "Duplicate patient ID [...].
* Remove patient tubes and verify which one should be used."
VI
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Safety Instructions
EVOLIS Twin Plus Version 1.00 – User Manual
Safety Instructions
EVOLIS Twin Plus is a fully automated microplate analyzer including
functions such as sample preparation, test performance, photometric
measurement and data evaluation.
EVOLIS Twin Plus is designed and manufactured in accordance with the
safety requirements for electronic and medical measuring devices. If the law
lays down regulations on the installation and/or operation of microplate
analyzers, then it is the operator's responsibility to adhere to them.
The manufacturer has done everything possible to guarantee that the
equipment functions safely, both electrically and mechanically. The systems
are tested by the manufacturer and supplied in a condition that allows safe
and reliable operation.
The user has to observe the information and warnings contained in this
manual in order to ensure safe operation of the instrument.
Please adhere to the following safety instructions when handling or
operating the system:
• The instrument may only be operated by specialized personnel
who have been trained on the use of the system.
• The instrument may only be operated by specialized personnel
who are aware of the potential risks connected with the use of
hazardous chemical and microbiological agents. Adequate
personal protective equipment should be worn at all times.
• Use the system only for the designated application.
• Use only the consumables described herein (microplates, primary
tubes, pipetting tips, etc.).
• The manufacturer assumes no liability for any damages, including
those to third parties, caused by improper use or handling of the
system.
• The system is designed according to the regulations of IEC 1010-1
or EN 61010-1 for electrical measuring systems.
• The instrument should be opened, serviced and repaired by
qualified personnel only.
• The operator may only perform the maintenance work described in
this manual. Use only the parts described in this manual for
servicing.
• The instruments are live. Improper handling may cause damage.
• Do not take off the protective cover during a run and do not reach
into the working area. If you open the flap of cover, verify that the
movement of the pipettor has stopped before you reach in the
working area.
• Use grounded connectors to connect all instrument and
peripherals to mains supply.
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VII
Safety Instructions
EVOLIS Twin Plus Version 1.00 – User Manual
•
•
•
•
•
VIII
If you can see that the unit has become unsafe to use, switch it off
and disconnect it from the power supply.
If liquid gets inside the instrument, disconnect the power cord and
clean the respective parts using appropriate cleaners (in particular
those spots that are crucial to operation).
Spare fuses must match the values specified by the system
manufacturer.
The tests and maintenance work recommended by the
manufacturer should be performed to make sure that the operator
remains safe and that the instrument continues to function
correctly.
Any service and maintenance work not described in this User
Manual must be performed by Bio-Rad Service Engineers.
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1. System Overview
EVOLIS Twin Plus Version 1.00 – User Manual
1
System Overview
1.1
Instrument Description
➊
➋
➐
➏
➎
➒
➑
➓
➍
➌
Figure 1: System Overview
Touchscreen
System cover
Wash solutions, trap flask and vacuum flask
Sample and reagent loading unit
Pipettor
Microplate loading and pipetting position
Back compartment (washer, incubators and photometer)
Tip racks
Dilution plates / large reagent bottles (diluent)
Tip evacuation slide (& tip waste bag [not visible])
Power switch and connection panel (not visible)
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1. System Overview
EVOLIS Twin Plus Version 1.00 – User Manual
1) Do not use sharp metallic objects to operate the touchscreen!
The touchscreen may be operated directly with your finger or with any
non metallic touchscreen pen.
2) Always use the handle to open and close the instrument cover!
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1.2. Software Overview
EVOLIS Twin Plus Version 1.00 – User Manual
1.2
Software Overview
Main screen (Worklist)
➊
➋
Figure 2: Software Overview
Main toolbar
Worklist toolbar
Main toolbar icons
<File>
<Stop>
<New Worklist>
<Load Tips>
<Open>
<Utilities>
<Save>
<Windows>
<Print>
<Help>
<Import>
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1. System Overview
EVOLIS Twin Plus Version 1.00 – User Manual
Worklist toolbar icons
<Worklist
Parameters>
<Scroll> (Page Up)
<Schedule>
<Scroll> (Line Up)
<Plate Layouts>
<Edit Panel…>
<Reagent List>
<Edit Options…>
<Instrument Status>
<Other Options…>
<Log View>
<Start>
<Job List>
<Scroll> (Line Down)
<Sample Archiving>
<Scroll> (Page Down)
The Worklist toolbar is displayed only when a worklist is open. In other
windows (e. g. Result report window), the left-hand side toolbar is
different. The upper toolbar ("main toolbar") is always visible.
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2.1. Getting Started
EVOLIS Twin Plus Version 1.00 – User Manual
2
Daily Routine Operation
2.1
Getting Started
2.1.1
Check Liquid Levels (Start-Up Maintenance)
➊
➋
Figure 3: System liquid and liquid waste containers
System liquid container
Liquid waste container
1. Make sure the system liquid container is full or almost full and correctly
connected to the system.
2. Make sure the liquid waste container is empty and connected to the
system.
The system-liquid container and the waste container must always be
positioned lower than the instrument itself.
When reconnecting the containers, make sure the level sensors and
tubings are correctly set.
See also
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Prepare system-liquid, Decontaminate waste container, see Section 3.20.
13
2. Daily Routine Operation
EVOLIS Twin Plus Version 1.00 – User Manual
2.1.2
Start-Up
1. Make sure the instrument cover is closed; switch on the system with
the switch located on the right-hand side of the instrument. On the
touchscreen, WindowsTM starts automatically.
2. On the screen, double-click on the EVOLIS Twin Plus icon to start the
EVOLIS Twin Plus software.
3. The Log-On dialog box is displayed. Click <Log-On>.
Figure 4: Logging in
4. In the Make a Selection dialog box, all registered users are displayed.
Click on your user name.
5. Use the touchscreen keyboard to enter your password, then click
<OK>.
6. The instrument initializes and all modules are checked. At the end of
the initialization process the Selftest window is displayed.
Figure 5: Self-Test window
If all instrument modules have a "Passed" status, you can safely start
working with the system.
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2.1. Getting Started
EVOLIS Twin Plus Version 1.00 – User Manual
See also
Users and passwords, see Section 3.18.
Demo Mode, see Section 3.19.
Incorrect password, see Section 4.
Initialization failure, see Section 4.
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2. Daily Routine Operation
EVOLIS Twin Plus Version 1.00 – User Manual
2.2
Prepare and Load Samples
Check visually the quality of the samples you are intending to process
(clots, foam…). To avoid clots, proper treatment (e.g. centrifugation)
of patient samples is recommended.
1. Make sure all sample tubes have barcode labels.
2. Place the sample tubes in the sample racks (rack code $T) provided
with the EVOLIS Twin Plus system.
3. Make sure all barcode labels face right.
4. On the EVOLIS Twin Plus system, one of the yellow LEDs in front of
the sample and reagent unit should be lit. If no LED is lit, reinitialize the
barcode scanner by inserting a sample rack on any track (all the way
down the track) and removing it immediately.
5. Take the first sample rack you want to load and insert it on the track
marked by the yellow LED. Push it in evenly so that all sample
barcodes can be read by the integrated barcode scanner.
If the rack has been correctly read, a brief sound is heard and the
yellow LED on the next track lights up.
If the rack has not been correctly read, the sound is repeated three
times and the first LED keeps flashing. Pull out the rack and insert it
again.
6. If the rack has been correctly read, wait until the following dialog box is
displayed.
Figure 6: Loaded samples with test orders
In this dialog box, the sample IDs read by the barcode scanner are shown
on the left-hand side and the assay names are listed in the top buttons.
Checkmarks show which tests are selected for each loaded sample. If there
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2.2. Prepare and Load Samples
EVOLIS Twin Plus Version 1.00 – User Manual
are no checkmarks and/or no tests displayed in the upper buttons, see
Section 3.16.
7. Click the green arrow to scroll down the list of loaded samples and
make sure all sample IDs have been correctly read.
8. Click the <Close> button to close this dialog box.
On the EVOLIS Twin Plus system, another yellow LED lights up to
indicate where you should load the next sample rack.
9. Insert the second sample rack and wait for the Patient Editor dialog
box to open again.
10. Repeat these steps until all sample racks are loaded.
For proper barcode identification, sample racks must be loaded one
after the other as described above. Never try to load several racks at a
time without waiting for the Patient Editor dialog box to open.
See also
Unreadable sample barcodes, see Section 3.2.
Non-standard sample tubes, duplicate sample tubes, see Section 3.3.
Import test orders, see Section 3.16.
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2. Daily Routine Operation
EVOLIS Twin Plus Version 1.00 – User Manual
2.3
Check and Validate the Worklist
Whenever you load patient samples corresponding to imported test
requests, as described above, the system automatically suggests an
appropriate worklist. All you need to do is to check and validate this worklist.
1. In the upper toolbar, click the <New Worklist> button. This opens the
Set-up Panel dialog box showing the worklist automatically suggested
by the system.
➊
➋
➌
Figure 7: Check Worklist
Plates zone
Plate Layout
Assays zone
The Plates zone shows how many plates are included in the worklist.
The Assays zone shows the name(s) of the assay(s) assigned to this
plate and above, the actual plate layout is presented.
2. Click successively on each plate listed in the Plates zone to see how
the worklist is organized (plate layouts and tests programmed on each
plate).
3. List and prepare the Bio-Rad kits that you will need to process the
assays included in this worklist.
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2.3. Check and Validate the Worklist
EVOLIS Twin Plus Version 1.00 – User Manual
4. As a general rule, it is recommended to accept the worklists suggested
by the system. Click <OK> to validate the worklist.
Declare reagent lots
When you click <OK> to accept the worklist in the Set-up Panel dialog box,
the following dialog box is displayed.
Figure 8: Declare reagent lots
1. Take the kit package you intend to use for the first test. Note the batch
number, printed on the box next to the
indication.
2. Click the <Edit Batch Number…> button. In the Make a Selection
dialog box, select the batch number corresponding to the one printed
on the kit box.
The kit Batch Number and the Expiry Date are automatically updated.
Figure 9: Updated batch number and expiry date
3. Click <OK> to validate and repeat these steps for the other kits/tests
included in the worklist.
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2. Daily Routine Operation
EVOLIS Twin Plus Version 1.00 – User Manual
printed on the kit package is not listed in the
If the batch number
Make a Selection dialog box, this means the kit you are intending to
use is the first one from a new batch that has not yet been entered in
the kit lot tracking database. You can click <Add Kit…> to enter it now
as described in Section 3.4.
It is not possible to use two boxes of the same type of kit with
different batch numbers in the same run.
If batch numbers and expiry dates are already listed in the Lot
Specific Values dialog box when this dialog box opens, these are from
the batch used in the last run!
To update this data it is essential that you always click <Edit Batch
Number…> and select the correct batch number from the Make a
Selection dialog box.
Worklist window
Once you have declared the reagent lots for all kits/tests in the Lot Specific
Values dialog box, the worklist window is displayed.
Figure 10: Worklist window
1. Click the various buttons in the first column of the worklist toolbar (in
the left-hand side of the screen) to review the worklist. If something is
incorrect and you need to go back to the Set-up Panel dialog box, click
<Edit Panel…>.
20
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2.3. Check and Validate the Worklist
EVOLIS Twin Plus Version 1.00 – User Manual
2. Click the <Reagent List> button to display the list of all required
reagents.
Figure 11: Reagents' list
3. If you want to print that list (recommended), click the <Print> button in
the upper toolbar.
4. Click the <Start> button in the worklist toolbar to open the Load dialog
box and complete the loading process.
See also
Edit plate ID, see Section 2.4.5.
Optimize schedule, see Section 3.9.
Multi-assay per plate, see Section 3.10.
Add external controls, see Section 3.4.
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2. Daily Routine Operation
EVOLIS Twin Plus Version 1.00 – User Manual
2.4
Complete the Loading Process
When you click the <Start> button in the worklist toolbar the Load dialog
box opens showing you where to load all required resources.
➊
➋
➍
➌
Figure 12: Load dialog box
Wash solutions and rinse fluid
Pipetting tips
(if any) Dilution plates, diluent, archive plates
Samples and reagents
1. Load all required resources as described in this dialog box. The
detailed loading procedure for each resource type is described in the
following pages. It is recommended to follow the indicated loading
sequence. When done, click <OK>.
In the Load dialog box, clicking on any resource displays the details
(name, volume…) of this resource.
For samples and reagents, use the Zoom tool to make clicking easier.
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2.4. Complete the Loading Process
EVOLIS Twin Plus Version 1.00 – User Manual
2.4.1
Wash Solutions and Rinse Fluid
Figure 13: Load wash solutions
The second part of the reagent list you previously printed (see Figure 11)
indicates which quantity of each solution is required for the planned worklist.
1. Fill each wash solution container with the appropriate solution. The
containers are color-coded (on the screen and on the tubings
connected to the container caps). Fill and reconnect the containers one
at a time to avoid mix-ups. Click successively on each container in the
Load dialog box to display the name of the wash solution you have to
fill in that container. Under default settings, the red-capped container is
reserved for rinse fluid (deionized water).
2. When reconnecting the containers, make sure the level sensors (inside
the containers) and the outside tubing are correctly positioned.
If you mix-up wash solutions (fill a solution in the wrong container),
this cannot be detected by the system. It is the operator's
responsibility to make sure each wash solution has been loaded in
the appropriate container.
2.4.2
Dilution Plates (if any)
➊
Blue
Green
Green
➋
➌
Figure 14: Load dilution and archive plates (if any)
No dilution plate and no archive plate required
Dilution plate (green) required
Dilution plate (green) and archive plate (blue) required
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2. Daily Routine Operation
EVOLIS Twin Plus Version 1.00 – User Manual
See Section 3.6 on how to load dilution plates and diluent.
The sample archiving function is not described in this user manual. If you
want to use this function, please contact your local Bio-Rad representative.
Special conditions may apply.
2.4.3
Pipetting Tips
Figure 15: Load tips
1. Load the pipetting tips. Color code is as follows.
Gray
Brown
Red
Gray
Load a full tip rack with 96 X 1100 µl tips.
Brown
Load a full tip rack with 96 X 300 µl tips.
Red
The respective (1100 µl or 300 µl) incomplete tip racks
should already be loaded (remaining tips from the previous run). Just
check that the required number of tips is available in each rack
(required number is indicated by small figure in upper part of the rack
picture).
2. When inserting the tip racks, make sure the slot in the tip rack is
correctly positioned.
After inserting the tip racks, push them down firmly again to make
sure they are level.
Always observe the position of the tip racks defined in the Load dialog
box! Using a short tip instead of a long one may cause splashing and
contamination. Using a long tip instead of a short one may cause the
pipettor to crash and be damaged. Note that the system can be
configured to perform an automatic tip size check. For more
information, please call Bio-Rad Technical Support.
See also
24
Tip management options, Reloading tips during a run, see Section 3.7.
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2.4. Complete the Loading Process
EVOLIS Twin Plus Version 1.00 – User Manual
2.4.4
Reagents
a) Before
b) After
Figure 16: Load reagents
The first part of the reagent list you previously printed (see Figure 11)
indicates all the reagents required for the planned worklist.
1. Open the kits you prepared for this worklist. Load all reagents and
controls listed in the first part of the list on the reagent racks.
2. Make sure all barcode labels face right.
3. Remove the bottle caps.
4. Insert the reagent racks one by one on the EVOLIS Twin Plus
instrument on the tracks marked by a flashing yellow LED.
If an error message is displayed when you insert the large reagent rack
(rack $1), see Section 3.4.
When all reagents are loaded, in the Load dialog box, all reagents
should be shown in the rack loading unit. The Unallocated resources
corner (top right) should be empty (see above Figure 16 b).
5. Check visually once again that all resources have been loaded as
depicted in the Load dialog box and click <OK>.
Before going further, make sure all caps on reagent bottles and control
vials have been removed!
If you intend to re-use controls and reagents later, store all caps
appropriately to avoid any mix-up when recapping and storing the
bottles.
See also
Non-barcoded reagent bottles, Unreadable barcodes, see Section 3.2.
Size-adaptors for reagent bottles, Control racks, Unstable reagents, see
Section 3.4.
Large reagent bottles (diluents), see Section 3.6.
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2. Daily Routine Operation
EVOLIS Twin Plus Version 1.00 – User Manual
2.4.5
Test Plates
When you click <OK> in the Load dialog box, the Load Plate dialog box is
displayed. The system assigns a default name to each plate:
"Plate NYYMMDDXX"
(in which: N = Plate rank in the current worklist, YY = Year, MM = Month, DD
= Day, XX = Plate rank for that date).
Figure 17: Load plates
1. To enter a customized Plate ID, click the <Plate ID…> button and enter
a new plate ID via the keyboard. The plate ID you enter will replace the
"Plate N" part of the default name. The system will still add the
"YYMMDDXX" tag to your customized name.
For example, if you enter "HIV_" instead of "Plate 1", the final Plate ID
will be: "HIV_YYMMDDXX".
2. Take the microplate out of the respective Bio-Rad kit. Make sure the
microplate includes enough strips (at least as many strips as shown in
the Plate Layout of the Load Plate dialog box.).
3. Lift the instrument cover and load the microplate into the plate support
at the back of the instrument deck.
A1
4. Make sure the A1 corner of the microplate is at the rear right and
corresponds to the A1 mark on the plate support.
Push the microplate down firmly so that its surface is perfectly
horizontal.
5. Click <OK>. The microplate moves in. The Load Plate dialog box is
closed then reopens to let you load the next microplate.
6. Repeat these steps for each microplate included in the worklist.
Always load full strips! Even if you use microplates with breakable
wells and only some wells are required on some strips, do not remove
unrequired wells.
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2.4. Complete the Loading Process
EVOLIS Twin Plus Version 1.00 – User Manual
See also
Microplate identification (no barcode identification), see Section 3.2.
Multi-assay per plate, see Section 3.10.
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2. Daily Routine Operation
EVOLIS Twin Plus Version 1.00 – User Manual
2.5
Run
Once you click <OK> after loading the last microplate, the run starts
automatically.
Figure 18: Schedule view during the run
Once the run has started, it is recommended to avoid any interference
with the system unless prompted by a message on the screen.
You can nevertheless follow what the system is currently doing by toggling
between these different views.
Schedule view The Schedule view provides a chronological presentation
of the current processing (see Figure 18 above and Section 3.9).
Log view The Log view records all processing events and actions as they
are performed (see Section 3.8).
Instrument status view the Instrument status view is useful to check
incubation temperatures or whether some racks are fully processed (light
indicator turns from red to green when a rack is fully processed).
See also
Schedule, see Section 3.9.
Logs, see Section 3.8.
Continuous loading, see Section 3.13.
Reloading tips during a run, see Section 3.7.
Errors during the run, see Section 3.11.
Emergency stop, see Section 3.12.
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2.6. Run Results
EVOLIS Twin Plus Version 1.00 – User Manual
2.6
Run Results
As soon as the processing of a plate is finished, the system generates the
result report for this plate. The system generates one result file per plate, not
per worklist or per assay.
Figure 19: Result window
You can review the result report on the screen (use the scroll buttons in the
left-hand side toolbar) or click the <Print> button (upper toolbar) to obtain a
printout.
An "auto-print" option is available. If this option is enabled, the result report is
printed automatically when displayed on the screen. For more information on
this option and how to enable it, please call Bio-Rad Technical Support.
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2. Daily Routine Operation
EVOLIS Twin Plus Version 1.00 – User Manual
2.6.1
Understanding / Validating Result Reports
When using Bio-Rad predefined assays, the result report always includes
the following sections.
➐
➊
➋
➌
➑
➍
➎
➏
Page 1
Page 2 / Page…
Figure 20: Printed result report
General information & Important warnings
Expected kit components
Incubation information
Reader values (OD values)
Validation criteria
Quantitative results
Qualitative results
Combined report
Depending on the type of test, additional information may be included such
as:
30
•
Verify Dispense – If one or more Dispense verification steps were
included in the assay processed on the plate, the Result Report includes
a corresponding number of "Verify Dispense" sections (generally on the
first page, before the "General info" section). In these, you can check if
some wells have not been correctly pipetted/ dispensed into. These
wells are displayed in red.
•
Graphs – For some tests (e.g. quantitative, semi-quantitative tests), the
result report includes concentration or standard/concentration graphs.
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2.6. Run Results
EVOLIS Twin Plus Version 1.00 – User Manual
When reviewing a result report, observe the following recommendations.
1. Check the Validation criteria section
If this section includes one or more FAILED mentions (in bold red type),
some major error occurred.
All results on the plate are invalid. You must retest all samples on that
plate!
2. Check the Important warnings section
This section (at the end of the General information section) signals cirtical
events that occurred during the run and may have had a negative impact on
the results.
WARNING! Assay was paused for […].
WARNING! Ambient temperature tolerance of […]°C was exceeded (…°C).
WARNING! Incubator tolerance of +/- …°C was exceeded (…°C).
WARNING! Results have not been processed using the original assay.
WARNING! Shaking problem during incubation.
WARNING! Results obtained from a recalled plate map.
WARNING! The Washer may have run out of reagent during processing.
Reagent […], barcode […], was not found in the kit database.
[Reagent "…"] manually assigned to posn. […]
Plate barcode entered manually.
ATBarco time difference: […].
Removed wells: [...]
Restored wells: […]
If this section includes any of these warnings, all results on the plate
must be individually reviewed and validated by the laboratory
supervisor.
3. Review the Combined report
The Combined report displays the results per sample of all samples on the
plate).
Pay special attention to:
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•
The results of the control wells (NC, PC, etc.) in the top part of the
Combined report.
•
The Flag column. For more information on flags, their meaning and
consequences, see Section 3.14.
•
Wildcard signs (*) or (*****). These indicate that no value could be read
(e.g. the wells were not correctly dispensed) or that no result could be
calculated (e.g. if the values read were not within the test validation
criteria).
31
2. Daily Routine Operation
EVOLIS Twin Plus Version 1.00 – User Manual
See also
Flags, see Section 3.14.
Recalculate results, see Section 3.15.
Expected kit components, see Section 3.4.
2.6.2
Export Results
1. Once you have reviewed and validated the results, click the <Export
Results> button in the left-hand side toolbar to export the results to the
LIS (or to another folder or network location).
If you do not click the <Export Results> button, when you try to close
the displayed result file, the system asks you again if you want to
export the results.
Figure 21: Export prompt
2. Click <Yes> to export the results and close the file, click <No> to close
the file without exporting the results.
See also
32
Export, see Section 3.17.
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2.7. End of Run
EVOLIS Twin Plus Version 1.00 – User Manual
2.7
End of Run
2.7.1
Unload / End of Run Maintenance
Be careful when unloading as some items (test plates, dilution plates,
sample tubes, etc.) may contain contaminated material. Discard in
accordance with local regulations on biological hazardous waste.
Figure 22: Unload plates
1. Unload the microplates one by one, each time this message is
displayed. When removing the microplate from the plate support, lift
carefully to avoid spilling.
As stated in the message, once you have unloaded the first microplate,
you need to re-close the instrument cover, click <OK>, and wait for this
message to be displayed again before you can unload the next
microplate.
2. Unload reagent and sample racks, dilution plate and diluent (if any).
Store reusable resources (e.g. reagents) in accordance with the
conditions prescribed in the kit inserts.
Dispose of test plates, dilution plates and sample tubes in accordance
with local regulations for biological hazardous waste.
3. If your system is configured to reuse partial tip racks, do not unload the
tip racks unless they are completely empty. If your system is configured
to use only full tip racks, unload or refill the partially used tip racks.
4. Check the bag of the tip ejection waste container. If full or nearly full,
replace as described in Section 3.20.
5. Check the liquid waste level in the liquid waste container. If full or
nearly full, decontaminate and empty as described in Section 3.20. If
necessary, refill the liquid-system container.
You can now either start a new run or shutdown the system as described in
the following Section.
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2. Daily Routine Operation
EVOLIS Twin Plus Version 1.00 – User Manual
2.7.2
Shutdown / End of Day Maintenance
1. Make sure all processing has ended. Perform the end of run
maintenance described above.
2. Close the EVOLIS Twin Plus software. Select File | Exit from the
menu bar or click the X icon in the top right-hand corner of the
EVOLIS Twin Plus software window.
3. Exit Windows.
4. Wait until Windows displays the following message:
"It is now safe to turn off your computer".
5. Switch off the system (switch on right-hand side of the instrument).
Always exit the EVOLIS Twin Plus software and the Windows software
before switching off the system!
6. Open the instrument cover and wipe the tip adapter (pipettor head)
using a soft lint-free cloth moistened with 70% Ethanol.
7. Inspect the instrument (inner and outer surfaces) for stains and spills. If
necessary, clean as described in Section 3.20.
34
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3. Advanced Information
EVOLIS Twin Plus Version 1.00 – User Manual
3
Advanced Information
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3.1
Assays
3.2
Barcodes
3.3
Samples
3.4
Reagents and Controls
3.5
Non Bio-Rad Kits
3.6
Dilution Plates and Diluents
3.7
Pipetting Tips
3.8
Logs
3.9
Schedule
3.10
Multi-Assay per Plate
3.11
Pipetting Errors
3.12
Pausing a Run / Emergency Stop
3.13
Continuous Loading
3.14
Flags
3.15
Recalculate Results
3.16
Import
3.17
Export
3.18
Users Rights and Passwords
3.19
Demo Mode and Connections
3.20
General Maintenance Tasks and Maintenance Schedule
35
3. Advanced Information
EVOLIS Twin Plus Version 1.00 – User Manual
3.1
Assays
The EVOLIS Twin Plus system is supplied with pre-defined assay protocol
files (APF). Under default settings, these assay files (files with an *.asy
extension) are stored in the C:\BioRad\2PS\Resources\APF directory.
Determining which assay file to use
Each pre-defined assay file corresponds to a specific Bio-Rad test. To
determine which assay file you should use for a given test, please refer to
the EVOLIS Twin Plus APF Manual which includes a correspondence table
between Bio-Rad kits and EVOLIS Twin Plus assay files.
Note that in some cases, the same kit can be used with different assay files;
for example, when the same kit can be used for a qualitative and a
quantitative test, a different assay has to be selected for each test. It is
therefore essential to select the appropriate assay.
If in doubt, you can open and review the predefined assay files as described
below or call Bio-Rad Technical Support for advice on which assay to use.
Disclaimer - Bio-Rad pre-defined assays are validated for use with
Bio-Rad kits only. Bio-Rad accepts no liability when using Bio-Rad predefined assays with non Bio-Rad kits.
Similarly, Bio-Rad accepts no liability for user-defined assays.
Opening and reviewing a pre-defined assay file
Before processing an assay (especially if it is the first time you are using this
assay), you may want to review the various steps to be performed, the task
sequence, the incubation times, the reagents used, etc.
To open and print an assay file:
1. In the main toolbar, click the <Open> button. this opens the Make a
selection dialog box.
2. In the Make a selection dialog box, select the "Assay file (*.asy)" icon
and in the next dialog box, select the assay file you want to review.
3. Use the scroll buttons to scroll down the list or the <Filter…> button to
find the file you need more easily.
For example: enter "hiv" with the keyboard to display all assay files with
"HIV" in the assay file name.
4. A password prompt is displayed if the assay file is password protected.
Click <Don't Know Password>. The assay file is displayed.
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3.1. Assays
EVOLIS Twin Plus Version 1.00 – User Manual
Figure 23: Assay file
Review it on the screen or click the <Print> button in the upper toolbar to
review the printout.
If you need help in understanding the contents of an assay file, please
call Bio-Rad Technical Support.
APF upgrades
New APF (Assay Protocol Files) versions are regularly released. These
include new Bio-Rad pre-defined assays but also new versions of existing
assays, validated for the most recent software version.
The best way to avoid problems is to install new software and APF versions
as soon as possible. Using old software versions with newly released APF
files or vice-versa is either impossible or may lead to errors and/or loss of
guarantee.
If you want to upgrade your system or inquire about the latest available
versions, call Bio-Rad Technical Support.
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3. Advanced Information
EVOLIS Twin Plus Version 1.00 – User Manual
3.2
Barcodes
Sample barcodes
It is recommended to use only barcoded sample tubes. When installing the
system, your Bio-Rad Service Engineer will help you make sure the barcode
labels you generally use on sample tubes are adequately read by the
system's integrated barcode scanner.
Unreadable sample barcodes
If, when you insert a rack, the system fails to read a sample barcode, when
the Patient Editor dialog box opens (see Section 2.2), the respective
sample ID (on the left-hand side of the dialog box) is replaced with a
<None> button.
1. Click <Close> and remove the rack.
2. Make sure the sample tube is correctly positioned (barcode label facing
right), note the sample ID and reinsert the rack.
3. When the patient Editor dialog box is displayed again, if the barcode
still cannot be read, click the <None> button, enter the sample ID via the
touchscreen keyboard and click <OK>.
In the result report (in the Combined report), the respective sample will
have a "ManID" flag to indicate that it has been manually identified.
Reagent barcodes
It is recommended to use only barcoded reagent bottles. Most Bio-Rad kit
bottles are pre-barcoded. For non-barcoded reagent bottles, Bio-Rad
supplies separate sets of barcode labels for each type of kit. Please order
the appropriate barcode labels and attach them to the bottles before use.
Unreadable reagent barcodes
If, when you load the reagent racks (see Section 2.4.4), the system fails to
read a reagent barcode, in the Load dialog box, the respective reagent is
considered as unloaded and remains in the Unallocated resources corner
instead of being shown on a reagent rack.
38
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3.2. Barcodes
EVOLIS Twin Plus Version 1.00 – User Manual
Figure 24: Unreadable reagent barcode
1. Click on that reagent in the Unallocated resources corner to
determine which reagent could not be read.
2. Remove the reagent rack on which this reagent is loaded, make sure
the reagent bottle is correctly positioned (barcode label facing right)
and note its position on the rack.
3. Reinsert the rack. If the system fails to read the barcode again, click on
the reagent in the Unallocated resources corner, then click on the
rack position in which you actually loaded the bottle to allocate the
reagent manually into the rack.
In the result report, a warning will be added to the Important warnings
section to indicate that this reagent was manually allocated. It is the
operator's responsibility to ensure that no error was made (wrong rack
position) when allocating reagents manually.
Microplate barcodes
The EVOLIS Twin Plus system is not equipped with a barcode reader for
microplates. Microplates can only be identified manually by the operator.
If the operator mixes up microplates from different kits (e.g. loads a
plate from an HIV kit for an HCV test), this will not be detected by the
system. It is therefore essential to make sure to load the correct
microplate for each test.
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3. Advanced Information
EVOLIS Twin Plus Version 1.00 – User Manual
3.3
Samples
Non standard sample tubes
The standard sample racks ($T) accommodate up to 16 tubes with a
diameter between 10 and 16 mm and a height not exceeding 10 cm.
If you need to use smaller size tubes (e.g. pediatric or Eppendorf tubes),
narrower tubes or tubes with a specific shape, contact Bio-Rad Technical
Support to adapt and re-align your racks accordingly. The adapted racks will
be identified by colored stickers and, in the Load dialog box; these racks will
be displayed in the corresponding color and identified by a different code
letter.
The EVOLIS Twin Plus system cannot accommodate sample tubes
exceeding 10 cm in height. The samples must be transferred into smaller
tubes to be processed.
Duplicate samples
If you load two samples tubes with the same barcode, an error message is
displayed.
"Duplicate patient ID [...].
* Remove patient tubes and verify which one should be used."
Remove one of the sample tubes or use another barcode on one of the
tubes.
40
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3.4. Reagents and Controls
EVOLIS Twin Plus Version 1.00 – User Manual
3.4
Reagents and Controls
Reagent and control racks
Most reagent bottles included in Bio-Rad kits can be directly loaded onto the
reagent and control racks supplied with the EVOLIS Twin Plus system.
Standard racks
Large reagent rack (Rack code $1) 8 reagent bottles (Ø 39 mm x 2 et
Ø 35 mm x 6) can be loaded on this rack. For diluent bottles with a diameter
greater than 39 mm, see Section 3.6.
With
height-adaptors
Control rack (Rack code $2) 16 control vials can be loaded on this rack.
This rack is specially designed (with height-adaptors on the bottom of each
loading position) to make it possible to load directly the small control and
calibrator vials included in most Bio-Rad kits.
Special cases
Without
height-adaptors
Rack for controls transferred into tubes (Rack code 3) This rack
(without height-adaptors on the bottom of individual loading positions) is
intended for controls that have been transferred into tubes (identical to
sample tubes). Control transferred into tubes should not be loaded on
ordinary sample racks (Rack code $T).
Adaptors for small diameter bottle Small diameter reagent bottles
(Ø 25 mm) can be loaded on a large reagent rack ($1) when using special
size-adaptors provided with the system.
It is the operator's responsibility to make sure that all reagents are
correctly loaded and, more specifically:
• That controls transferred into tubes are not loaded on a $2 rack
(without height-adaptors) or on an ordinary sample rack $T.
• That small diameter bottles are not loaded on the $1 reagent rack
without using a size-adaptor.
Incorrectly loaded reagents can cause pipetting errors or even induce
damage to the pipettor itself.
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3. Advanced Information
EVOLIS Twin Plus Version 1.00 – User Manual
Rack loading error (large reagent rack)
Because of the grid located above the sample and reagent unit, the large
reagent rack can only be loaded on certain tracks (otherwise the pipettor
cannot get through the grid to aspirate from the bottles). If you load the rack
on an unsuitable track, the following message is displayed.
"The rack has not been positioned in the sample rack in a manner
compatible with the grid.
* Please replace the rack in another track."
In that case, click <OK>, remove the rack, wait for another yellow LED to
light up indicating on which track to reload the rack.
Unstable reagents (extemporaneous reagents)
Some unstable reagents have to be prepared separately and loaded on the
instrument only after the run has begun. If an unstable reagent is required, it
will be listed in the Reagent requirements list (see Figure 11) and, in the
Schedule view of the run, a symbol (purple lozenges) in the "Additional
resources" line allows you to know when the reagent will have to be loaded
(see Section 3.9).
When the Load dialog box opens (see Section 2.4), load all required
reagents except the unstable reagent. Allocate the unstable reagent
manually, i.e. click on that reagent in the Unallocated resources corner
then click on the rack position where you will later load it.
Before the reagent is actually needed, the system prompts you with an
acoustic signal and a message on the screen to prepare and load the
reagent:
"Prepare [name of reagent] and load in […] minutes".
It is recommended that you do not wait until this message is displayed
to prepare the reagent (i.e. you should anticipate its preparation).
1. Click <OK> to close this message. The processing of the worklist
continues and when the indicated time span is over, the Load dialog box
is displayed again with an additional message:
"Please load the requested items as soon as possible as the system is
paused".
2. Remove the reagent rack in which you initially allocated the unstable
reagent.
3. Place the reagent bottle in the position indicated in the Load dialog box.
4. Reinsert the rack and only then click <OK>.
42
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3.4. Reagents and Controls
EVOLIS Twin Plus Version 1.00 – User Manual
Reagent Lot Tracking
The EVOLIS Twin Plus software includes a kit database used for kit lot and
reagent lot tracking. If the lot tracking function is enabled, when you load
reagents for a run, the system checks that they correspond to the kit lot data
stored in the database.
If you want to use the lot tracking function, your Bio-Rad Service Engineer
will enable it when installing the system and you then need to declare each
new kit lot in the kit database as described below.
The use of an external (handheld) barcode scanner is strongly
recommended for this procedure. If this equipment was not installed
initially, please ask your Bio-Rad Service Engineer for assistance
before installing one yourself.
1. Select the Utilities | Add Kit… menu item. This opens the Kit
Information dialog box.
Figure 25: Declare reagent lots
2. With the handheld scanner, scan the main kit barcode on your kit box.
Assay Name
Batch Number
Expiry Date
Main Kit Barcode
Product Code
Figure 26: Kit information on kit package
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3. Advanced Information
EVOLIS Twin Plus Version 1.00 – User Manual
3. All general kit information (except the kit expiry date) is automatically
entered. Click the <Edit…> button next to the Expiry Date field.
4. Use the touchscreen keyboard to enter the expiry date, then click <OK>.
5. Click <Scan kit Bottles…>. This opens the following dialog box. The Kit
drop-down list shows the batch number of the kit package you have just
entered.
Figure 27: Scan kit bottles
6. Open the kit package and load all reagents and controls on the reagent
racks.
7. Load the racks one by one on the EVOLIS Twin Plus instrument on
the tracks marked by a flashing yellow LED. The individual reagent
barcodes are read and the corresponding data is displayed in the Scan
Kit Bottles dialog box (Column 1 = Reagent ID, Column 2 = Lot
number of individual reagent, Column 3 = Individual reagent expiry date
[Date format = DDMMYY]).
Some generic reagents (e.g. stop solution) are overlooked in this
process. This is normal. They do not need to be tracked.
8. Click <Close> to close the Scan Kit Bottles dialog box. In the Kit
Information dialog box, the complete kit lot data is now entered.
9. Click <OK> to save and close the Kit Information dialog box.
Expected reagent barcodes / Expected kit components
If you use the reagent lot tracking function (see above), when you load the
reagents on the instrument, the system controls that all reagent bottles
correspond to the references entered for each kit lot in the kit database.
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3.4. Reagents and Controls
EVOLIS Twin Plus Version 1.00 – User Manual
If you exchange reagent bottles between kits and the system cannot find the
expected barcodes, a message is displayed:
"Reagent Lot Tracking Error For Reagent [...]'
Expected barcode(s): [list of all reagent barcodes expected for that assay]...'
Scanned barcode: [barcode of first unexpected reagent]...'
The message tells you the expected ID and the scanned ID. A new message
is displayed for each "unexpected" reagent (i.e. reagent for which the
scanned barcode ID does not correspond to the expected barcode ID).
Click <OK> to close the message. Pull out the reagent rack and check the
reagent(s) mentioned in the message.
If you can find the correct reagent(s) with the expected barcode ID, reload
the rack with only expected reagents.
If you are unable to load the reagent bottles with the expected barcodes, you
can, if necessary, turn the incorrectly labeled bottles so that the unexpected
barcodes cannot be scanned, reload the rack and assign these reagents
manually in the Load dialog box The system then assumes that the
expected reagent has been loaded but reports the manual assignment in the
Result Report.
This is a "troubleshooting" procedure done under the operator's sole
responsibility. The operator's action is logged but it actually voids the
lot tracking function.
In the result report (see Section 2.6.1), the Expected kit components
section allows you to track after the run, which reagent lots were used for
each test. Manually allocated reagents are also shown in the Important
warnings section.
External controls
External controls (i.e. controls other than those provided in the Bio-Rad kits)
may be added to any plate.
For more information on this function, please call Bio-Rad Technical
Support.
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3. Advanced Information
EVOLIS Twin Plus Version 1.00 – User Manual
3.5
Non Bio-Rad Kits
This manual describes only how to use the EVOLIS Twin Plus system to
process Bio-Rad kits. If you want to process non-Bio-Rad kits, please ask
Bio-Rad Technical Support for assistance. Special conditions may apply.
Bio-Rad accepts no liability when using Bio-Rad pre-defined assays
with non Bio-Rad kits.
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3.6. Dilution Plates and Diluents
EVOLIS Twin Plus Version 1.00 – User Manual
3.6
Dilution Plates and Diluents
Dilution plate types
As a rule, pre-dilution plates are not included in Bio-Rad kits. When
installing the system your Bio-Rad Service Engineer will preset hardware
and software settings according to the type of dilution plates you generally
use.
Make sure to always use dilution plates corresponding to this preset
plate type. If you later want to use another type of dilution plate, you
must call your Bio-Rad Service Engineer to edit the settings.
Loading dilution plate and diluent
1. If the test requires a pre-dilution plate, this will be shown in the Load
dialog box (see Section 2.4). Dilution plates are displayed in green
(sample archiving plates are displayed in blue).
2. Before loading the dilution plate, make sure that a metal plate is
inserted in the compartment in which you intend to load the dilution
plate.
3. Load the dilution plate. Push the microplate down firmly so that its
surface is perfectly horizontal.
4. If the diluent bottle is small enough to be inserted in a reagent rack,
place it in the rack and load it with the other reagents as described in
Section 2.4.4.
If the diluent bottle is too large to be inserted in a reagent rack, load it
next to the dilution plate.
5. In that case, you have to allocate the diluent bottle manually. In the
Load dialog box, click on the diluent bottle in the Unallocated
resources corner, then click on the second dilution compartment. No
barcode identification is available when diluents are loaded in this
position.
A "cup-shape" adaptor is needed in order to load 125 ml diluent bottles
next to the dilution plate. These adaptors can be ordered from Bio-Rad
(see Accessories and Consumables' list in Appendix A 2).
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3. Advanced Information
EVOLIS Twin Plus Version 1.00 – User Manual
3.7
Pipetting Tips
Use only the pipetting tips specially supplied by Bio-Rad for the
EVOLIS Twin Plus system!
Tip management options
There are two main tip management options:
•
Either you decide to systematically load full tip racks (96 tips per rack) at
the beginning of each run,
or,
•
You allow the system to start a run with the tips left over from the
previous run (incomplete racks).
When installing the system, your Bio-Rad Service Engineer will configure
the system according to your preferred option. In the Load dialog box (see
Section 2.4), full tip racks are displayed in brown (for 300 µl tips) or gray (for
1100 µl tips), incomplete tip racks are displayed in red (for both tip sizes),
see Section 2.4.3.
If tips run out during a run
If the system anticipates that it will be necessary to reload tips during the
run, this is indicated in the Schedule view of the worklist (see Section 3.9).
When the system runs out of tips, it pauses the run and displays a message
prompting you to reload. The system cover is unlocked to let you reload the
tips. It is recommended to reload rapidly to avoid pausing the run for too
long.
For 300 µl tips only, it is possible to configure the system to abort a plate if
tips run out or to log and continue instead of pausing the run. For more
information on this option, please call Bio-Rad Technical Support.
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3.8. Logs
EVOLIS Twin Plus Version 1.00 – User Manual
3.8
Logs
Log files record in real time the steps of a run as they are performed.
Colors
Different colors are used in the log.
Black
Describes all steps that have been correctly performed.
Red
Signals any problem occurring during the run (e.g. incorrect dispense,
system paused, errors...)
Green
Signals actions taken by the operator to enable the system to resume or
continue the run.
The logs of all runs performed on the same day are aggregated in the same
log
file.
By
default,
log
files
are
saved
in
the
C:\BioRad\2PS\Resources\Event_log directory. They have a (*.log)
extension and the file name corresponds to the date on which the run(s) was
(were) performed:
e.g. "20070228.log" (YYYYMMDD)
To view the log file for the current day (during of after a run):
1. In the worklist toolbar (left-hand side of the Worklist window), click the
<Log> button.
To view the log file for runs performed on previous days:
1. In the main toolbar, click the <Open> button.
2. In the Make a selection dialog box, select the log icon and in the next
dialog box, select the log file for the day of the run you want to
investigate.
3. Once the log file is open, a <Filter…> button (in the left-hand side
toolbar) allows you narrow down your search to a specific worklist, a
specific plate and a specific sample.
When the log file is created (i.e. during a run), the scripting is done so that
the current step is always at the top while earlier steps are further down. But
when you open a formerly saved log file, the daily chronological order is
rearranged from start-up to shutdown.
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3. Advanced Information
EVOLIS Twin Plus Version 1.00 – User Manual
Use
The log is an important document. It can:
•
Be followed while the run is being processed so that you can react
quickly to correct any problem.
•
Be used, after the run is over, to check whether all steps have been
properly performed. If, for example, some results are flagged, the log
enables you to understand why.
•
Be reviewed at a later date to check how the run was processed.
The wording used in the log file is generally simple and descriptive, making it
easy to follow for any operator after minimal use of the system. If you require
assistance in understanding a particular log file, you can copy the file (from
the C:\BioRad\2PS\Resources\Event_log directory) and mail it to your BioRad Service Engineer.
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3.9. Schedule
EVOLIS Twin Plus Version 1.00 – User Manual
3.9
Schedule
Schedule view
Once a worklist is defined, the Schedule view allows you to see precisely
how the run will actually be processed and when reloading will be allowed or
required. During the run, the vertical time bar shows which step is currently
being performed.
➌
➊
➍
➋
➎
Figure 28: Schedule view
Schedule per module
Schedule per plate
Vertical time bar
Load additional resources:
Load additional tips (see Section 3.7)
Load unstable reagents (see Section 3.4)
"Brown sections" for continuous loading (see Section 3.13)
Optimize schedule function
To try and optimize the schedule (i.e. attempt to process more samples,
more tests in a shorter time), you can, before actually starting the run,
select the Edit | Optimize menu item.
The system then reschedules to calculate the best possible solution (e.g.
reorganizes the order in which the plates will be processed).
Walk-away options / Specific workloads
Depending on your laboratory organization and on the tests you usually
perform, your Bio-Rad Service Engineer, when installing the system, can
configure various options to suit your specific priorities: high throughput, less
operator intervention, use of robust or sensitive tests, etc.
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3. Advanced Information
EVOLIS Twin Plus Version 1.00 – User Manual
3.10
Multi-Assay per Plate
The EVOLIS Twin Plus system allows you, under certain conditions, to
combine several assays on the same test plate, e.g. Toxo IgG and Toxo
IgM.
If you import worklists / test orders from the LIS and you use barcoded
samples, the combination of several assays per plate is managed
automatically by the system. When suggesting a suitable worklist for the
samples you loaded, if the assays are compatible and the number of
samples is not too great, the system always tries to combine as many
assays as possible on each plate.
For the operator, performing a run with several assays per plate is very
similar to an ordinary run.
Main differences are as follows:
1. When declaring the reagent lots in the Lot Specific Values dialog box,
there is one tab per assay. Do not forget to declare the values on each
tab before clicking <OK>!
2. When you reach the Load Plate dialog box, pay special attention to the
plate layout and particularly, the number of strips used for each test.
Figure 29: Loading a multi-assay plate
3. You will need to take a microplate from each of the two (or more) kits
and rearrange the correct number of strips for each test in one
microplate.
Be careful not to mix-up strips! When microplates supplied in BioRad kits have removable strips, a 2-digit code is engraved on each
strip for easy identification.
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3.10. Multi-Assay per Plate
EVOLIS Twin Plus Version 1.00 – User Manual
Always load full strips! Even if you use microplates with breakable
wells and only some wells are required on some strips, do not remove
unrequired wells.
Always start the second (third) assay on a new strip (default setting). If
you want to avoid "loosing" some wells, please ask Bio-Rad Technical
Support for assistance as to how to solve this problem.
4. When the result report is displayed (once the processing has ended),
the results corresponding to each assay are displayed one after the
other, with the same order that they had on the plate (i.e. full results for
Assay 1, then full results for Assay 2...).
5. Similarly, when the results are exported, the results for all assays
processed on the same plate are included in the same result file.
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3. Advanced Information
EVOLIS Twin Plus Version 1.00 – User Manual
3.11
Pipetting Errors
Samples
When using Bio-Rad assays, if a pipetting error occurs on a sample, the
processing will continue normally but the error is traced in the log file and the
sample will be flagged in the Combined report according to the type of
problem detected: clot, insufficient liquid, no liquid… (see Section 3.14).
Controls and calibrators
When using Bio-Rad assays, if a pipetting error is detected on a control, the
system prompts the operator to dispense the control manually at the end of
the control dispense step. If the operator actually dispenses the control as
requested, in the Combined report, the control will have a ManPip (Manual
pipetting) flag but the results will be calculated. If the operator does not
dispense the control manually, this generally leads to a test failure (FAILED
mention in the Validation criteria section of the result report).
Reagents
When using Bio-Rad assays, if a pipetting error is detected on a reagent, a
message is displayed:
"Aspirate check failed in reagent […]"
Three options are available:
•
<Retry> The pipettor dispenses the aspirated liquid back in the source
reagent bottle and repeats the aspirate step.
•
<Abort plate> The system aborts the plate for which the reagent is
needed.
•
<Continue> The system resumes the processing but all remaining
samples requiring this reagent will have a Clot flag.
If this error message reoccurs several times in succession while the
reagent bottles seem to be correctly loaded and filled, this may signal
a pipettor hardware error. In this case, it is recommended to call BioRad Technical Support.
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3.11. Pipetting Errors
EVOLIS Twin Plus Version 1.00 – User Manual
Avoid/detect pipetting errors
The EVOLIS Twin Plus system includes a series of devices/ functions
specifically designed to avoid and detect pipetting errors.
Pre-run checks
Reagent volume check (optional but recommended)
The pipettor controls that each bottle contains enough reagent for the
planned worklist.
Sample volume check (optional)
The pipettor controls that each sample tube contains enough liquid for the
planned worklist.
Tip size check (systematic)
The pipettor controls one tip of each tip rack to make sure that long tips and
short tips have been loaded as requested in the Load dialog box.
During the run
Verify Dispense
Photometric control of adequate reagent or sample dispense.
Aspirate check / Liquid level detection
When pipetting out of a container, the pipettor controls that the liquid level
drop corresponds to the aspirated volume.
Pressure monitoring
Barometric control on aspirate steps.
When installing the system, you Bio-Rad Service Engineer will
configure these for optimal use and safety.
DO NOT attempt to change the initial settings by yourself. Always call
your Bio-Rad Service Engineer for assistance.
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3. Advanced Information
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3.12
Pausing a Run / Emergency Stop
Click the <Stop> button in the upper toolbar to pause the run. The following
dialog box is displayed.
Figure 30: Pause the run
You can then choose to restart the processing (<Resume>), to select one or
more plates and click <Abort Plate> or abort the complete worklist. If you
click <Abort Plate> or <Abort Worklist>, a confirmation message will be
displayed.
Consequences of a system pause
Whenever the system is paused, a warning and the duration of the pause is
indicated in the Important warnings section of the result report (see Section
2.6.1). Pauses are also traced in the log files.
If the system is paused and you remove and reload a sample rack that
was not fully processed, any sample that will be pipetted from that rack
after you have removed and reloaded it will be flagged SplRem and that the
respective results will not be calculated.
If the system is paused and you remove and reload a reagent rack that
was not fully processed, all the samples which had not yet been pipetted
when the rack was removed will be flagged RegtRem but the corresponding
results will still be calculated.
If the system is paused but you resume the run without opening the
system cover and without removing any racks, the processing continues
normally (for all non-aborted plates).
Emergency stop
In extreme emergencies it is recommended to simply unplug the system.
In all other cases, it is preferable to pause the system as described above,
abort the worklist and shutdown normally as described in Section 2.7.2.
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3.13. Continuous Loading
EVOLIS Twin Plus Version 1.00 – User Manual
3.13
Continuous Loading
Continuous Loading is the process by which new patient samples and new
test plates are reloaded while the system is already running. This is possible
on the EVOLIS Twin Plus system under certain conditions.
1. Prepare the sample racks with the new samples.
2. Check the LEDs at the front of the sample loading unit. You can
remove all the racks for which the LEDs are flashing.
3. In the Worklist window, switch to Schedule view and check the
"Additional plates" line. Brown sections on this line indicate times when
additional plates can be loaded (all current plates are incubating and
the pipettor is inactive). It is therefore recommended to start reloading
when the vertical time bar is nearing or has just entered a brown
section.
4. Insert the first rack with new samples on the track marked by a yellow
LED. If no LED is lit, reinitialize the barcode scanner by inserting a
sample rack on any free track (all the way down the track) and
removing it immediately. When the LED lights up, insert the rack
normally.
5. Review and validate the Patient Editor for this rack and repeat the
process if you have other racks to load.
6. In the Worklist toolbar (on the left-hand side of the screen), click the
<Edit panel…> button. This opens the Set-up Panel dialog box and
you can see the new plates that have been automatically added to the
worklist.
7. Click <OK> and continue as for a normal worklist. After you have
clicked <OK> in the Lot Specific Values dialog box, the system
checks its current status.
8. Case 1) If you are still within a "brown section" (all current plates
are incubating and the pipettor is inactive), the system displays a
message stating:
Note: The current worklist has been paused.
Press the "Start" button when you are ready to proceed with the new
worklist.
…and allows you to continue the reloading process.
9. Click <OK> to close the message, then click the <Start> button in the
Worklist toolbar and reload all required resources (reagents, dilution
plates, tip racks, wash buffer, test plates) as in a normal worklist.
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10. Case 2) If you are not or no longer within a "brown section", the
system displays a message stating:
You will be able to add plates in […] minutes. Please try again then.
11. Wait until the specified time has elapsed (or until the time bar enters a
brown section in the Schedule view), then click the <Edit panel…>
button again and follow the steps described above.
When loading the resources for the new samples, it is important that
you load them as quickly as possible so that the processing is not
paused for too long.
If some of the plates of the initial worklist are already fully processed
when you are ready to reload additional plates, the system
automatically brings them forward to the loading/unloading zone so
that you can remove them before loading the additional plates.
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3.14. Flags
EVOLIS Twin Plus Version 1.00 – User Manual
3.14
Flags
Flagged results are not necessarily wrong results. A flag indicates that
something happened during the run that may have affected the result on this
patient sample.
The software uses 12 general flags and 6 pressure monitoring flags to give
an indication of the type of problem encountered.
SplRem
Sample rack removed. This flag is used if a sample rack has been removed
before it had been completely pipetted. No results are calculated for
samples that had not yet been pipetted at that stage.
RgtRem
Reagent rack removed. This flag is used if a reagent rack has been
removed during processing. This does not affect result calculation (the
results are calculated).
ManID
Manual ID. This flag is used if a sample ID has been manually assigned. .
This does not affect result calculation (the results are calculated).
If a manually assigned sample is used for several assays (through direct
pipetting or through pipetting of the same predilution made from this
sample), the ManID flag is included in the Result Report for each assay.
NoLiq
No liquid detected. Results for flagged samples are not calculated.
InsLiq
Insufficient liquid detected. Results for flagged samples are not calculated.
Clot
Clot detected. Results for flagged samples are not calculated.
PipErr
Pipettor hardware error. Results for flagged samples are not calculated.
ManPip
Manually pipetted resource. This flag is used when controls or samples have
been manually pipetted into the test plate. This does not affect result
calculation (the results are calculated).
VCFail
Validation criteria failure. Results for flagged samples are not calculated.
VDFail
Verify dispense failure. This flag is used when a reagent / sample / control
has not been correctly dispensed into a well. Results for flagged samples
are not calculated.
IncKo
Incubation overrun. This flag is used when there is a discrepancy between
the incubation temperature / time actually observed during a run and the
incubation temperature / time defined in the assay. Results for all samples
on an incorrectly incubated plate are not calculated.
REAG EXP
Reagent Expired. This flag is used when a reagent was used after its expiry
date. When an expired reagent is loaded and identified, the user is warned
that the expiry date has been reached/exceeded but can choose to override
the warning and still use the reagent for the run.
This does not affect result calculation (the results are calculated).
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P_max_high,
P_min_low,
P_stop_high,
P_static_high,
P_static_low,
P_mean_low
flagged
Pressure monitoring flags. These flags can be reported only if the pressure
monitoring function is enabled. In case of recurring pressure monitoring
flags, call Bio-Rad Technical Support.
P_max_high
Aspiration pressure too high
Clot
P_min_low
Aspiration pressure too low
Foam or air
P_stop_high
Pressure at pump stop too high
Clot
P_static_high
Static pressure too high
Clot
P_static_low
Static pressure too low
Foam or air
P_mean_low
Mean pressure too low
Foam or air
(displayed in red) This flag replaces multiple flags when results in the
Combined Report are displayed in Matrix format.
1) When results are flagged but calculated, it is the biologist's /
laboratory supervisor's responsibility to check the result report and
the log file, to find out precisely why a particular result was flagged.
Only then will it be possible to determine whether the result can be
accepted as valid or if the patient sample must be re-tested.
2) When a result has been flagged and not calculated, it is possible, in
some cases, to force the system to calculate the result in spite of the
problem that occurred (see Section 3.15). This is also done under the
biologist's / laboratory supervisor's sole responsibility.
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3.15. Recalculate Results
EVOLIS Twin Plus Version 1.00 – User Manual
3.15
Recalculate Results
When a Result report is displayed, the <Outliers…> button (in the left-hand
side toolbar) allows you to manually remove from the results some OD
values which you think are not consistent with the test or conversely to
restore a value which has been automatically removed from the calculation
by the software (flagged sample).
1) The <Outliers…> button is enabled only if you have sufficient user
rights.
2) Even if you have sufficient user rights, the Log On dialog box will be
displayed before you can access the Outliers dialog box and you will
have to log yourself on again.
Figure 31: Editing outliers
You cannot edit the values but only remove or restore them. A removed
value is displayed crossed out.
1. To remove (or restore) a value, select it with the mouse and then click
the <Remove> (or <Restore>) button.
2. Click <OK>. The program returns to the result report. Removed (or
restored) wells are listed at the bottom of the General information and
Important warnings section.
To then recalculate the results without the removed values or with the
restored values, click the <Recalculate> button (in the left-hand side
toolbar).
The new result report includes the following comment: "WARNING! Results
have not been processed using the original assay."
If several assays were processed on one plate, you can view the DO values
for each assay by clicking the <Assay Protocol> button (in the top left
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3. Advanced Information
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corner of the dialog box) and selecting the assay you want. The <Reading>
button shows the wavelength(s) used for the reading.
Recalculating flagged results
The <Restore> button of the Outliers dialog box can be used to force the
system to calculate results for flagged samples that have automatically been
removed from result calculation.
This possibility can only be used for samples with the following flags:
SplRem (Sample rack removed), VDFail (Verify dispense failure) or
IncKo (Incubation overrun).
Results that have been eliminated because of NoLiq (No liquid
detected), InsLiq (Insufficient liquid), Clot (Clot detected), PipErr
(Pipettor hardware error), VCFail (Validation criteria failure) cannot be
recalculated!
To do so:
1. In the original Result Report, display the Combined Report part.
2. Check the flagged samples.
3. If you want to recalculate some of these flagged samples, note their
locations on the plate (layout labels).
4. Open the Outliers dialog box and restore the corresponding wells
(layout labels) as described above.
5. Recalculate the Result report as described above.
6. In the recalculated Result report, the selected flagged results are now
calculated but the original flags remain.
It is the biologist's/ laboratory supervisor's responsibility to check and
validate all recalculated results.
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3.16. Import
EVOLIS Twin Plus Version 1.00 – User Manual
3.16
Import
When installing the system, your Bio-Rad Service Engineer will configure
the communication links and import process (file format, file polling
interval…) so that the EVOLIS Twin Plus can import and interpret test
orders sent by the LIS (Laboratory Information System).
The import process is then performed automatically and does not require
any user intervention.
When test orders are correctly imported, when you load barcoded samples
on the instrument, the Patient Editor is displayed with checkmarks
indicating which tests are required for the loaded samples as described in
Section 2.2.
If there are no checkmarks in the Patient Editor when it opens, this can
mean several things.
Figure 32: Patient Editor without test orders
Case 1 – Your test order files include only sample IDs but no information on
the tests to be performed (e.g. in situations where all samples are
systematically tested with the same test panel). In that case:
1. Click successively the <None> buttons located above the table and
select an assay for each column.
2. Add checkmarks manually by clicking in the appropriate table cells. Do
not forget to click the green arrow button to scroll down to the bottom of
the table.
3. When done, click <Close>.
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Case 2 – No test order for the respective sample IDs was sent by the LIS or
no test order for the respective sample IDs was received by the EVOLIS
Twin Plus. In that case:
1. Click <Close> to close the Patient Editor dialog box.
2. Click the <Import> button in the upper toolbar to manually force an
import process.
3. Reload the sample rack on the track marked by a yellow LED and wait
until the Patient Editor is displayed again.
If the Patient Editor is still blank (no checkmarks), please contact your LIS
administrator. If your LIS administrator cannot solve the problem, please call
Bio-Rad Technical Support.
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3.17. Export
EVOLIS Twin Plus Version 1.00 – User Manual
3.17
Export
When installing the system, your Bio-Rad Service Engineer will configure
the communication links so that the EVOLIS Twin Plus result files can be
exported to the LIS (Laboratory Information System) or to another folder or
network location.
Note however that the export process is not automatic. Each result file has
to be exported individually by the operator (see Section 2.6.2).
Example of export file
[HIV Ultra Ag-Ab 1P BR V13]
[Results]
Patient ID|Assay|Well|Flag|Value|S/CO|Result
""|"HIV Ultra Ag-Ab 1P BR V13"|"A1"|""|"2,0650"|"6,1950"|"PC Ag1"
""|"HIV Ultra Ag-Ab 1P BR V13"|"B1"|""|"2,1860"|"6,5580"|"PC Ab1"
""|"HIV Ultra Ag-Ab 1P BR V13"|"C1"|""|"0,1380"|"0,4140"|"NC1"
""|"HIV Ultra Ag-Ab 1P BR V13"|"D1"|""|"0,1260"|"0,3780"|"NC2"
""|"HIV Ultra Ag-Ab 1P BR V13"|"E1"|""|"0,1360"|"0,4080"|"NC3"
"000001"|"HIV Ultra Ag-Ab 1P BR V13"|"F1"|"ManID"|"0,1160"|"0,3480"|"NEG"
"000002"|"HIV Ultra Ag-Ab 1P BR V13"|"G1"|"ManID"|"0,1080"|"0,3240"|"NEG"
"000003"|"HIV Ultra Ag-Ab 1P BR V13"|"H1"|"ManID"|"0,1770"|"0,5310"|"NEG"
"000004"|"HIV Ultra Ag-Ab 1P BR V13"|"A2"|"ManID"|"0,9000"|"2,7000"|"REACTIVE"
"000005"|"HIV Ultra Ag-Ab 1P BR V13"|"B2"|"ManID"|"0,8150"|"2,4450"|"REACTIVE"
"000006"|"HIV Ultra Ag-Ab 1P BR V13"|"C2"|"ManID"|"0,6620"|"1,9860"|"REACTIVE"
"000007"|"HIV Ultra Ag-Ab 1P BR V13"|"D2"|"ManID"|"0,4760"|"1,4280"|"REACTIVE"
"000008"|"HIV Ultra Ag-Ab 1P BR V13"|"E2"|"ManID"|"0,3710"|"1,1130"|"REACTIVE"
"000009"|"HIV Ultra Ag-Ab 1P BR V13"|"F2"|"ManID"|"0,2240"|"0,6720"|"NEG"
[…]
Block export if VC fail
It is possible to systematically block the export of results when the test
validation criteria have failed.
1. Select the Utilities | Options menu item to open the Options dialog box
and select the Preferences tab.
2. To block exports if VC fail, deselect the Export results if VC fail
checkbox.
Re-export results
If you try to re-export results that have already been exported, the following
message is displayed.
"These results have already been exported to the LIMS.
Are you sure you want to export them again?"
Click <Yes> to re-export, click <No> to stop the second export.
In general, when a result is exported to the LIS, in case a second
discordant result is re-exported, due to the use of the Restore or
Remove outliers function (see Section 3.15), the user shall inform the
laboratory’s IT manager who shall undertake any action required by
the situation, because there is a risk that the LIS only takes in account
the first transfer.
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3.18
Users Rights and Passwords
User groups and user access rights
Under default settings, two pre-defined user groups are available:
Supervisors
Users
Full access group. Members of this group are allowed to use all the
functions available on the system. At least one supervisor is required per
system.
Restricted access group.
When installing the system, your Bio-Rad Service Engineer will create new
users and preset the user rights of each group of operators as requested to
reflect your laboratory organization.
For the following procedure, an external keyboard is required (see
Section 3.19). If you do not know how to install an external keyboard,
please call Bio-Rad Technical Support.
Set/ Reset password
To set or reset a password:
1. When logging in, enter your current password in the Password field and
click <OK>. If this is the very first time you log-in, leave the Password
field blank (or enter your temporary password if a temporary password
has been defined) and click <OK>.
2. Select the Utilities | Options menu item. In the Options dialog box,
select the Password tab.
3. Enter the required data (current password, new password, confirm new
password) and click the <Change> button. A message is displayed
confirming the password change.
4. Click <OK>.
If you need to reset your password because you have forgotten it, you first
have to seek the assistance of a supervisor or of another user who is
allowed to Administer Users and who can delete your former password.
To delete your former password the supervisor has to:
1. Log in under his/ her own user name and password.
2. Select the Utilities | Options menu item to open the Options dialog box
and select the Users tab.
3. In the Users tab, display the User Name drop-down list and select the
user name of the operator whose password is to be cleared.
4. Click the <Clear Password> button. A message is displayed to confirm
that the password has been cleared.
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3.18. Users Rights and Passwords
EVOLIS Twin Plus Version 1.00 – User Manual
5. Click <OK> to close the message, then click <OK> again to close the
Users tab.
The next time you log in under your own user name, you have to reset a new
password as described above.
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3.19
Demo Mode and Connections
Demo mode
If you want to use the EVOLIS Twin Plus software without the instrument,
start-up as usual (see Section 2.1.2) but when you reach the Log On dialog
box, select the <Demo mode> button (the green dot "lights up") before
clicking the <Log On> button.
Figure 33: Demo mode
Select Demo mode also if you install and use the EVOLIS Twin Plus
software on a separate computer.
Connections
A connection panel is located on the right-hand side of the system, above
the power switch.
Figure 34: Connection panel
This connection panel allows you to connect various accessories to the
system: keyboard, mouse, USB stick, CD drive, handheld barcode scanner,
etc.
It may be necessary to restart the system after plugging in a new
device. If you have any problem installing a new device, please call
Bio-Rad Technical Support.
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3.20. General Maintenance Tasks and Maintenance Schedule
EVOLIS Twin Plus Version 1.00 – User Manual
3.20
General Maintenance Tasks and Maintenance Schedule
Always turn off the instrument before cleaning!
Always wear adequate personal protective equipment: laboratory coat,
gloves and eye protection (safety glasses, splash goggles or face
shield).
Always follow Good Laboratory Practices.
Dispose of all waste in accordance with local regulations on biological
and chemical hazardous waste.
For all maintenance not described in this manual, please call your BioRad service Engineer.
System-liquid preparation
1. To prepare a full container of system-liquid, add 2 ml of Tween 20 to 10
liters of deionized water.
Liquid waste decontamination
1. Remove cap and pour bleach into the container (without emptying the
container first). With ordinary domestic-use bleach (12° chlorine), the
volume of bleach should equal 10% of the volume of liquid waste in the
container. Bleach tablets may also be used.
2. Let it stand for a minimum of 30 minutes (or overnight).
3. Empty the container and rinse it thoroughly with tap water.
When adding bleach, it is recommended that you operate under a fume
hood as chlorine fumes may occur.
After adding bleach, do not place the waste container screw cap back
on as this may damage the sensor. Spare waste containers with
ordinary caps may be ordered from Bio-Rad.
If bleach is not allowed in your country, use the decontaminating agent
you normally use instead of bleach.
The screw cap and sensor part may be wiped with a cloth moistened with
RIVASCOP® (diluted in water at 0.4% - 4 ml per liter).
Tip waste bag replacement
1. If the waste bag is protected by an outer protection panel with
transparent cover (optional equipment), remove the cover horizontally
from the front and unclip and remove the protection panel.
2. Lift waste bag off the retaining ring and close it using the supplied lid.
3. Place new waste bag with plastic reinforcing onto the retaining ring and
push it down, making sure it is correctly clipped on.
4. Attach front protection panel and transparent cover plate again (if
applicable).
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Dispose of the (sealed) waste bag in accordance with the legal
regulations for biological hazardous waste.
Surface decontamination
The following areas:
•
cover and handle,
•
outer panels (avoiding connection panel – see Section 3.19),
•
inner instrument deck (worktable),
• rack loading unit and upper grid,
…can be cleaned with any bactericide, virucide and fungicide hospital-grade
disinfectant. To prepare and apply the disinfectant (dilution, spray, wait,
wipe...) refer to the instructions prescribed by the product manufacturer.
For the touchscreen, use any standard (ammonia-free) product
recommended for the cleaning of computer monitors. It is recommended to
spray the cleaner on a clean cloth rather than directly on the screen to avoid
any liquid leaking inside the unit.
DO NOT try to lift or remove the inner instrument deck (worktable) and
do not try to move the instrument itself! If this happens accidentally,
call your Bio-Rad Service Engineer and do not use the system before it
has been realigned.
Do not use bleach or disinfectant which may damage metal parts. Do
not use disinfectants containing alcohol or acetone for Plexiglas
surfaces (cover).
Heavy liquid overflow
In case of heavy liquid overflow (e.g. damaged tubing, faulty washer…) into
or underneath the instrument while the system is running:
1. Switch off the EVOLIS Twin Plus system immediately (directly with the
switch located on the right-hand side).
2. Disconnect the power cord.
3. Clean-up all excess liquid following good laboratory practices for
possibly contaminated liquid.
4. Unload the system and perform a surface decontamination as described
above.
5. Call your Bio-Rad Service Engineer.
Do not use the system until it has been checked by your Bio-Rad
Service Engineer.
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Washer maintenance assays
Predefined washer maintenance assays are supplied with the system. In the
weekly procedure, the washer lines and manifold are rinsed with deionized
water. In the monthly procedure, the washer manifold is decontaminated
during 15 minutes in a decontamination solution (RIVASCOP® diluted in
water at 0.4%).
To run a maintenance assay:
1. Click the <New worklist> button in the upper toolbar.
2. In the Set-up Panel dialog box, click <Add Plate…>.
3. In the Set-up Panel: Plate dialog box, click <Add assay…> and select
the appropriate assay:
for weekly maintenance
WasherClean ETP BR.asy
for monthly maintenance
WasherManifoldDisinfect ETP BR.asy
4. Click <OK> to validate the various dialog boxes until you reach the
Worklist window.
5. Click <Start> and load the required resources (tips, deionized water,
decontamination solution for the monthly procedure, standard flat-bottom
microplate).
6. Start the run and follow the instructions on the screen.
Backup system files
Creating a backup of all system files is part of the monthly maintenance
routine.
1. Click the <Utilities> button in the upper toolbar. In the Make a
Selection dialog box, select Backup. The System Backup dialog box is
displayed.
Figure 35: Backup system files
2. Click <Backup System Files>.
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3. Advanced Information
EVOLIS Twin Plus Version 1.00 – User Manual
This creates backup copies of all current files that are not part of the
standard installation and stores them, under default settings, in an individual
directory created in the C:\BioRad\2PS\Backup directory. The name of the
individual system backup directory is formed as follows: "SYSyyyymmddnn"
(y = year, m = month, d = day, n = number of backups done on that day). A
new individual directory is created each time you launch a new backup
process (the previous backup is not overwritten).
Create a complete system backup every month. Do not delete previous
system backup directories manually. Save them as a way to trace back
your system history. If necessary, archive them on external media
(USB key, CD…).
Other maintenance tasks
Users should perform only the maintenance tasks described in this manual.
All other maintenance tasks (e.g. check and replace tubing, filters, fuses,
etc.) will be performed by your Bio-Rad Service Engineer as part of the
preventive maintenance visits.
Performance evaluation assays
Predefined performance evaluation assays are supplied with the system. As
a user, it is recommended that you run every month only the following
performance evaluation assays:
CTRL CV Pipettor Low Vol BR.asy
CTRL CV Pipettor High Vol BR.asy
CTRL Washer Aspirate ETP BR.asy
Æ on Plate 1
Æ on Plate 2
To run these assays, you will need to have a special Performance
Evaluation Kit (PE Kit) that you need to order from Bio-Rad, two standard
flat-bottom microplates and two 15 ml-bottles filled with tap water (the empty
bottles are included in the PE Kit).
To run these performance evaluation assays:
1. Click the <New worklist> button in the upper toolbar.
2. In the Set-up Panel dialog box, click <Add Plate…> to create the first
plate.
3. In the Set-up Panel: Plate dialog box, click <Add assay…> and select
the CTRL CV Pipettor Low Vol BR.asy file.
4. Do not add any samples. Just click <OK> to come back to the Set-up
Panel: Plate dialog box. Click <Add assay…> again and, this time,
select the CTRL CV Pipettor High Vol BR.asy file.
5. Do not add any samples. Just click <OK> to come back to the Set-up
Panel: Plate dialog box and click <OK> again to come back to the Setup Panel dialog box.
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3.20. General Maintenance Tasks and Maintenance Schedule
EVOLIS Twin Plus Version 1.00 – User Manual
6. In the Set-up Panel dialog box, click <Add Plate…> again to create the
second plate.
7. In the Set-up Panel: Plate dialog box, click <Add assay…> and select
the CTRL Washer Aspirate ETP BR.asy file.
8. Do not add any samples. Just click <OK> to validate the various dialog
boxes until you reach the Worklist window.
9. Click <Start> and load the required resources: tips, deionized water,
reagents (color solutions from the PE Kit) and tap water bottles,
standard flat-bottom microplates.
10. Start the run and follow the instructions on the screen.
11. When the result report for each plate is displayed, review the Validation
criteria section (see Section 2.6.1) for each assay (2 assays on the first
plate!). If any of the Validation criteria sections includes a FAILED
mention (in bold red type), call Bio-Rad Technical Support.
You can run these assays at any other time also if you suspect a malfunction
of the pipettor or of the washer.
A complete performance evaluation check of all instrument modules (plate
transport, photometer, pipettor, washer, and incubators) will be performed by
your Bio-Rad Service Engineer as part of the preventive maintenance visits.
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3. Advanced Information
EVOLIS Twin Plus Version 1.00 – User Manual
Maintenance Schedule
Daily Maintenance
Perform start-up maintenance (check liquid levels)
See Section 2.1.1.
Perform end-of-day maintenance and shutdown the
system.
See Section 2.7.2.
Weekly Maintenance
Run the weekly washer maintenance assay
Create a worklist for one plate using the weekly washer
maintenance assay and run it (see above).
Perform end-of-day maintenance and shutdown the
system.
See Section 2.7.2.
Clean the instrument surfaces and work areas
See above General Maintenance Tasks.
Decontaminate the sample and reagent racks and the
tip ejection slide.
Prepare a decontamination solution consisting of 0.4 % (4 ml per
®
liter) RIVASCOP and water in a container/sink large enough so
that you can immerse the racks and the slide completely.
Before immersing the racks and slide, set aside 5 ml of the
decontamination solution for the next step (see below).
Let them soak for a minimum of 15 minutes, longer in case of spills
or stains. Overnight if possible.
Rinse them thoroughly under tap water and allow to dry.
Decontaminate the pipettor wash station
Pour the 5 ml of the decontamination solution you set aside in the
previous step into the pipettor wash station.
Let it soak for a minimum of 15 minutes (overnight if possible). Do
not empty. The liquid will drain automatically when the system is
next reinitialized.
Monthly Maintenance
Backup system files
See above General Maintenance Tasks.
Run the monthly washer maintenance assay
Create a worklist for one plate using the monthly washer
maintenance assay and run it (see above).
Run the monthly performance evaluation assays.
Create a worklist for two plates using the monthly performance
evaluation assays and run it (see above).
Perform end-of-day maintenance and shutdown the
system.
See Section 2.7.2.
Decontaminate the system liquid container
Empty the container, then fill it with a decontamination solution
®
consisting of 0.4% (40 ml for 10 liters) RIVASCOP .
Without putting the cap back on, let it stand for a minimum of 15
minutes (overnight if possible).
Empty the container and rinse it thoroughly, twice with tap water
and once with deionized water.
Before refilling and reconnecting, inspect the filter (attached to the
cap). If damaged or particularly dirty, replacements can be ordered
from Bio-Rad.
Clean the wash buffer / clean fluid bottles
The wash buffer/clean fluid bottles can be either soaked and
washed by hand according to the procedure used for laboratory
glassware or cleaned in a laboratory dishwasher. Use the same
cleaning agents as for laboratory glassware.
Do not autoclave.
Clean the bottles only, NOT the caps and sensors.
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4. Troubleshooting
EVOLIS Twin Plus Version 1.00 – User Manual
4
Troubleshooting
The table below includes only warnings/ error messages on common
problems which you as a user may attempt to solve.
1) If the problem you encounter is listed in this table, follow the
"Recommended actions" described in Column 3. If the problem
persists, call Bio-Rad Technical Support.
2) If the problem you encounter is not listed in this table:
• Note the error message and, as far as possible, the circumstances
when the problem occurred.
• If the problem occurred during a run, abort the run (see Section
3.12), shutdown the system (see Section 2.7.2) and call Bio-Rad
Technical Support.
• If the problem did not occur during a run, shutdown and restart the
system. If the problem persists (initialization failure or error
message displayed again), call Bio-Rad Technical Support.
Problem / Message
Circumstance / Possible cause Recommended actions
Initialization failure (error warnings in
the Selftest window).
Upon start-up (see Section 2.1.2), when
one or more modules do not have a
"Passed" status.
In the upper toolbar, click the <Utilities>
button, then select Selftest to reinitialize
the system.
If the problem persists, call Bio-Rad
Technical Support.
Yellow loading LEDs do not light up.
When you intend to load sample or
reagent racks and no LED is lit.
To re-activate the barcode scanner you
can either:
The barcode scanner is in standby mode.
Insert any rack on any track and remove
it immediately.
In the upper toolbar, click the <Utilities>
button, then select Turn Scanner On.
[...] fatal error [...]: Reagent level low.
* Refill reagent bottle.
After clicking <OK> in the Load dialog
box or during the run.
<Retry>: the software checks the level
sensor again.
One of the wash solution containers is
empty.
<Abort>: the worklist will be aborted.
Refill the wash solution container and
click <Retry>.
If the error persists after refilling, call
Bio-Rad Technical Support.
[...] fatal error [...]: Waste full.\
* Empty waste container
During initialization procedure or during
the run.
Malfunction of the small washer waste
bottle "1" (located behind the wash
solution containers).
1
Check that the small washer waste
bottle "1" (located behind the wash
solution containers) has not accidentally
fallen and that the connecting tubing is
not twisted or pinched.
If the bottle is more than half full, empty
(contaminated waste!), reconnect and
click <Retry>. If the error persists,
please call Bio-Rad Technical Support.
Decontaminate all liquid waste as
described in Section 3.20.
[...] fatal error: System fluid low.
* Refill the system fluid container.
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During the initialization procedure or
during the run.
Refill the system liquid container (see
Section 3.20). When done, click <OK>.
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4. Troubleshooting
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Problem / Message
Circumstance / Possible cause Recommended actions
[...] fatal error: System waste full.
* Empty the system waste container.
During the initialization procedure or
during the run.
Replace the full waste container with an
empty one, reconnect and click <OK>.
Decontaminate all liquid waste as
described in Section 3.20.
A kit already exists with product
code [...] and batch number [...].
* Please enter a unique product code
and batch number.
When referencing a new kit lot.
If you are scanning the barcode on a kit
box, this means that this kit lot has
already been referenced in the kit
database. Exit the kit database. When
you start a run with this kit, click <Edit
Batch Number…> in the Lot Specific
Values dialog box and select the correct
batch number.
If you are entering the batch number
manually, check that you entered the
correct batch number. If the number you
entered is correct, see above.
Otherwise, try to enter the number
again.
The programmed run requires a dilution
plate to be loaded in a slot where a large
diluent bottle was loaded in the previous
run.
Make sure you have inserted a metal
plate under each dilution plate (see
Are you sure you want to abort all of
the plates?
The run is paused and you have clicked
the <Abort worklist> button
(confirmation message).
Click <Yes> or <No> as required (see
Are you sure you want to ABORT
plate [...]?
The run is paused and you have clicked
the <Abort plate(s)> button (confirmation
message).
Click <Yes> or <No> as required (see
Are you sure you want to export
these results to file and/or LIMS?
You clicked the <Export results> button.
See Section 3.17.
Aspirate check failed in reagent [...].
During the run. Liquid level detection
error on reagent aspirate step.
See Section 3.11.
Are the metal plates inserted below
the dilution/archive plates?
Section 3.6).
Section 3.12).
Section 3.12).
If the error persists, please call Bio-Rad
Technical Support.
Aspiration pressure to high
APM error (see Section 3.14).
The result will be flagged: P_max_high
Aspiration pressure to low
APM error (see Section 3.14).
The result will be flagged: P_min_low
Barcode error for reagent [...]!
* Ensure that the bottle with barcode
[...] is positioned correctly.
During the run. When loading an unstable
reagent.
Check the position of the reagent bottle
Clot detected/Aspirate check failed
in [...].
During the run.
See Section 3.11.
Crash recovery file detected.
Do you want to try and recover the
worklist?
Error on reagent aspirate step.
After power failure.
on the rack (see Section 3.4).
If the error persists, please call Bio-Rad
Technical Support.
<No>: System is reinitialized. Old
worklist will be deleted. <Yes>: The
following message appears:
"Is the system still running?"
<No>: The system initializes the
modules and continues the next worklist
step. <Yes>: The system continues with
the next worklist step.
Crash
recovery
is
not
recommended! Carefully check
the log file afterwards. If in
doubt, discard the results and
retest the samples!
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EVOLIS Twin Plus Version 1.00 – User Manual
Problem / Message
Circumstance / Possible cause Recommended actions
Duplicate patient ID [...]!
A manually entered sample ID is identical
* Edit the patient IDs so that only one to an existing sample ID.
tube is used per patient.
Check the manually entered sample ID.
It is not possible to have the same ID for
two sample tubes.
Duplicate patient ID [...].
* Remove patient tubes and verify
which one should be used.
Two loaded sample tubes have identical
barcodes.
Remove one of the sample tubes or use
another barcode for one of the tubes.
Error scheduling plate [...]
The system is unable to program the
current worklist. This message is
generally displayed after another
message stating what the problem is.
Click <OK> and try and correct the
problem indicated in the first message.
Error! Barcode [...] is not correct for
reagent [...].
During the run. When refilling a reagent
bottle.
Check the position of the reagent bottle
Error! Reagent [...] has not been
loaded!
During the run. The system prompted you
to load a reagent (e.g. unstable reagent
or reagent to be refilled) and the required
reagent was not loaded within the preset
time span.
If this message is displayed, you can still
load the required reagent but you will
need to check the results and the log file
carefully to see if the delay had an
impact. If in doubt, discard the results
and retest the samples!
Expected barcode(s): '(list of all
reagent barcodes expected for that
assay) [...]'
Lot tracking error.
Load the correct reagent bottle (from the
kit lot you have referenced in the kit
on the rack (see Section 3.4).
database - see Section 3.4).
Scanned barcode: '(barcode of first
unexpected reagent)[...]'
Please check the barcode and retry.
Incorrect password.
Try entering the password again.
You entered a wrong password.
Enter the correct password. Passwords
are case-sensitive! If you have forgotten
your password, see Section 3.18.
Insufficient volume of [...] detected.
During the run. Volume of reagent is
insufficient.
Please make sure that enough reagent
liquid is available and click <Refill
bottle>.
Otherwise, click <Abort Plate>.
Insufficient volume of [...] for the
worklist.
During pre-run reagent volume check.
Not enough reagent available in the
specified container.
Refill the specified reagent bottle.
Insufficient volume of [...], position
[...], for the worklist.
During pre-run wash solution volume
check. Not enough wash solution
available in the specified container.
Refill the specified container with the
required wash solution.
Lot number [...] does not exist!
Lot tracking error. The scanned lot
number does not exist.
Scan the correct lot number or update
the kit database.
Mean pressure too low
APM error (see Section 3.14).
The result will be flagged: P_mean_low
No disposable tips left
During the run. There are no more tips
available.
Load more tips (see Section 3.7).
No information could be found for
product code [...].
Lot tracking error. The scanned kit
barcode or the product code you entered
does not exist.
Enter the correct product code.
No kit information can be found for
this batch number.
Lot tracking error. The batch number
does not exist in the kit database.
Enter the correct batch number or
update the kit database.
No liquid detected for [...]
During the run. No liquid for reagent ... is
detected (this message is displayed only
if pre-run reagent volume check is
disabled).
Fill or reload a bottle of the required
reagent and click <Refill bottle>.
Continuous loading. The system allows
you to reload now.
See Section 3.13.
Note: The current worklist has been
paused.
Press the 'Start' button when you are
ready to proceed with the new
worklist.
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Otherwise, click <Abort Plate>.
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Problem / Message
Circumstance / Possible cause Recommended actions
Patient IDs: [...] are being run using
the same assay protocol multiple
times!
Are you sure you want to proceed?
Some of the samples in your worklist will
be tested twice with the same assay
(multiple selection).
Click <Yes> if this is intentional.
Otherwise click <No> and review the
worklist definition.
Pipette error [...] - pipetting step was
not confirmed.
Successful execution of the pipetting step
could not be confirmed.
Affected samples will be flagged: PipErr.
Please call Bio-Rad Technical Support.
Pipettor error 0x70 - Disposable tip
dropped [...].
* Please remove the tip from the
system.
The pipettor accidentally looses the tip
during a pipette or dispense step.
Available recovery options are <Retry>
or <Abort Plate>. If you click <Retry>,
the pipettor picks up another tip and
repeats the pipetting or dispensing
operation that was being performed
when the previous tip was lost.
Apart from the hazard of erroneous
results that may be caused by the
dropped tip itself (depending on where it
fell), it should be noted that clicking
<Retry> may result in the same pipetting
or dispensing operation being actually
performed twice.
Pipettor error 0x82 - Open
loop/overload error [...].
Pipettor crash during a run. Common
causes:
1) Crash in z direction, e.g. onto the rim
of a bent tube or forgotten reagent cap.
2) Horizontal crash, e.g. against an
obstacle left on the worktable.
Case 1) Try to correct the cause of the
crash (bent tube, reagent cap…) and
click <Retry>.
Case 2) Pipettor hardware may be
damaged and must be checked.
If in doubt, call Bio-Rad Technical
Support.
Please close system cover
Instrument cover is open.
Close the cover; otherwise the system
cannot start processing the worklist.
Reagent [...] is undefined
While the system checks the current
worklist.
When using Bio-Rad predefined assay
files, this error occurs only if the APF
files have not been correctly installed.
Call Bio-Rad Technical Support.
Reagent [...], barcode [...], was not
found in the kit database.
The reagent you loaded is not referenced
at all in the kit database.
Click <OK> to close the message.
Normally, if the reagent lot tracking
function is enabled, you should not use
reagents that are reported not found in
the kit database. Reference that reagent
in the kit database (see Section 3.4),
then reload the bottle.
Some barcodes were read
incorrectly. If you choose to
continue then the affected samples
will be flagged.
Continue anyway?
Unreadable sample barcode.
See Section 3.3.
Some required resources have not
been allocated to system positions!
When clicking <OK> to close the Load
dialog box. At least one required reagent
remains in the Unallocated resources
corner.
See Section 3.4.
Static pressure to high
APM error (see Section 3.14).
The result will be flagged: P_static_high
Static pressure to low
APM error (see Section 3.14).
The result will be flagged: P_static_low
When loading microplates.
Strip/well verification error!
* Please ensure that a well has been
inserted into the plate for each assay The microplate you loaded includes an
incomplete strip or not enough strips.
as shown in the plate load dialog
box.
78
Add the missing strips or wells (see
Section 2.4.5).
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3.20. General Maintenance Tasks and Maintenance Schedule
EVOLIS Twin Plus Version 1.00 – User Manual
Problem / Message
Circumstance / Possible cause Recommended actions
Suspect tip pick-up
During tip pick-up, the pipettor cannot
move deep enough into the tip and the tip
is not correctly attached.
After the error occurs the software goes
on with the next tip automatically.
Not enough system-liquid available.
Refill the system-liquid container (see
System fluid LOW.
If the error persists, the pipettor has to
be checked. Call Bio-Rad Technical
Support.
Section 3.20).
System waste FULL.
The main liquid waste container is almost
full.
Replace the full waste container with an
empty one, reconnect and click <OK>.
Decontaminate all liquid waste as
described in Section 3.20.
The disposable tips have been
incorrectly loaded.
During the tip type detection. System
detected large tips instead of small tips or
vice-versa.
After you have clicked <OK> the
software displays the Load dialog box
again so that you can check and correct
the loading position of the tip racks
(300 µl and 1100 µl tips).
The password for that user has been
cleared.
They should set a password when
they next log on.
After deleting a forgotten password.
See Section 3.18.
The pipettor is currently busy. The
pipettor shall need to be paused
whilst additional tips are loaded.
Are you sure you want to load
additional tips now?
When trying to reload tips during a run.
Click <OK> to close the message and
try again when the pipettor is inactive
(check the Schedule view of the
worklist).
The rack has not been positioned in
the sample rack in a manner
compatible with the grid.
* Please replace the rack in another
track.
When loading the large reagent rack.
Because of the grid above the sample
and reagent unit, the large reagent rack
can only be loaded on certain tracks.
See Section 3.4.
The rack in track [...] is not the same
as was originally loaded!
* Please load rack [...] in track [...].
Rack changed during refill bottle or
unstable reagent loading process.
Load the correct rack.
The reagent ID [...] is already in use
for this kit. Please enter a unique
reagent ID.
This reagent ID is already in the kit
database.
Enter a unique reagent ID.
The system is already running
another worklist.
Please wait until that worklist has
finished.
You clicked the <New Worklist> button
while the current worklist was not yet
finished.
If you want to add more samples/ plates
to a running worklist, please follow the
continuous loading procedure described
The worklist cannot be started
because some reagents have an
incorrect barcode.
* Check and reload the reagents.
Kit lot tracking error. The worklist cannot
be started until the error(s) have been
corrected.
Check that you have correctly
referenced the kits in the kit database
The worklist is currently active.
Are you sure you want to close this
window?
You tried to close the worklist window or
to close the software while the current
worklist is not finished.
Click <No> and wait until the end of the
run. If you want to abort the worklist, see
These results have already been
exported to the LIMS.
Are you sure you want to export
them again?
You tried to export results that have
already been exported.
See Section 3.17.
This will delete all patient
information and test requests! This
action cannot be undone!
Are you sure you want to delete all
patient information?
In the Patient Editor, you clicked the
<Delete All> button.
Unless you specifically want to delete all
patient information and test requests, it
is recommended to use the <Delete
(date)> aor the <Delete (Test)> buttons
instead of <Delete All>.
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in Section 3.13.
(see Section 3.4) and that you have not
exchanged reagent bottles between
different kit packages.
Section 3.12.
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4. Troubleshooting
EVOLIS Twin Plus Version 1.00 – User Manual
Problem / Message
Circumstance / Possible cause Recommended actions
Tip eject failure.
* Remove the tip from the pipettor.
The disposable tip could not be correctly
ejected from the pipettor after use.
Remove the tip manually, then click
<Retry>. The system goes on with the
next step.
If the error persists, the pipettor has to
be checked, call Bio-Rad Technical
Support.
Unable to calculate quantitative data
model. Check that there are
sufficient standards.
This error normally occurs only when
opening a result file (*.res) on a separate
computer (not the integrated system
computer).
Click <OK> to override the error
message and open the result file.
Unable to schedule the assay.
Possible reasons:
* No hardware found capable of
executing the assay instructions.
* No plate carrier available.
Assay requires hardware that is not
installed or more plate carriers that can
be processed by the system.
Edit worklist to delete the plate.
Unable to store control file [...].
This error normally occurs only when
opening a result file (*.res) on a separate
computer (not the integrated system
computer).
Click <OK> to override the error
message and open the result file.
Warning! Reagent [...] has expired!
(Expiry date [...].)
The expiry date of the reagent you loaded Click <OK> to close the message. You
is exceeded. The message tells you when can then either:
the expiry date was.
Start the run as is. The expired reagent
is traced in the log files and the
corresponding sample results are
flagged: REAG EXP
Unload the reagent and replace it with
an unexpired reagent. In this case, you
have to reference the new reagent in the
kit database.
You are not authorized to undertake
this action.
Please ask a supervisor for
assistance.
You do not have sufficient access rights
to perform this action.
See Section 3.18.
You cannot cancel this operation
because a new worklist has already
been scheduled. You must either
load or delete the additional plates.
Continuous loading error.
For continuous loading, follow the
You will be able to add plates in [...]
minutes. Please try again then.
During continuous loading, you have to
wait until all current plates are incubating
to add new plates.
80
procedure described in Section 3.13. To
abort some plates, see Section 3.12.
See Section 3.13.
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User Manual Code: 93502-m-EN
A. Appendices
EVOLIS Twin Plus Version 1.00 – User Manual
A.
Appendices
Last modification: 05 – 2008
User Manual Code: 93502-m-EN
A 1.
Technical Specifications ..................................................................82
A 2.
Accessories and Consumables .......................................................84
A 3.
Data Label ..........................................................................................87
A 4.
Symbols and Abbreviations.............................................................88
81
A. Appendices
EVOLIS Twin Plus Version 1.00 – User Manual
A 1.
Technical Specifications
Dimensions & Weight
Instrument size (H x W x D)
Instrument weight (without accessories)
115 x 125 x 90 cm
100 kg
Electrical
Voltage
Frequency
Power consumption
Fuse rating
100V - 240V
50 - 60 Hz
320 VA (mean)
4 AT
Operating conditions
General
Altitude
Noise level
Pollution degree
Installation class
Indoor use only.
No direct sunlight (may mislead
optical sensors and affect
performance)
15 - 30 °C
(storage 5 - 50 °C)
30 - 80 % (non-condensing)
(storage 10 - 85 % non-condensing)
< 2000 m above sea level
70 dB (A) at 1 m
2
2
Sample processing
Primary sample capacity
Dilution capacity (via tubes/plate)
Container (diameter & height)
Sample dilution
144
72/192
10-16 mm/50-100 mm
e
up to 1/10,000
Reagent processing
Calibrators & controls capacity
Reagents capacity
Reagents containers
Reagents identification
Lot & expiration management
16
16
Bio-Rad reagent bottles
internal BCR
yes
Disposable tips
Carbon tips
Volume (useable)
Liquid level & clot detection
On-board capacity (walk-away)
300-1,100 μl
10-1,000 μl
capacitive + air pressure
288 tips (3 x 96)
Temperature
Humidity
Processing features
Patient samples (100 μl/well)
Reagent (100 μl/well)
Dilution (1:10)
Precision (at 20 μl)
Accuracy (at 20 μl)
Precision (at 100 μl)
Accuracy (at 100 μl)
Incubation specifications
Number of incubators
Temperature Precision
Temperature Accuracy
82
~ 16 min/full plate
~ 4 min/full plate
~ 23 min/full plate
Single dispense
< 6% CV
< 10%
< 3% CV
< 5%
Multi-dispense
< 10% CV
< 10%
< 5% CV
< 5%
3 x ambient T
2 x from ambient T +5°C, up to 50°C
1.4°C
± 1.0°C
Last modification: 05 – 2008
User Manual Code: 93502-m-EN
A 1. Technical Specifications
EVOLIS Twin Plus Version 1.00 – User Manual
Last modification: 05 – 2008
User Manual Code: 93502-m-EN
Washer specifications
Manifold
Plate type (bottom shape)
Wash buffers
8 channels
flat, U- & V-shaped
2 x 2 l, 1 x 1 l
Photometer specifications
Reading head
Reading range
Filter wheel
Linearity (0-2.0 OD)
Precision (0-2.0 OD)
8 channels
0-3.5 OD
8 (equipped with 450, 492, 620)
1%
2.5%
Communication
Communication Port
On-line (bi-directional)
RS-232 Serial, USB 2.0, RJ-45
ASTM or ASCII format
83
A. Appendices
EVOLIS Twin Plus Version 1.00 – User Manual
A 2.
Accessories and Consumables
Description, Code No and availability are subject to change without
prior notice. Refer to the Bio-Rad catalog.
Only common accessories and consumables (i.e. for daily use) as
listed here. For all other parts not listed here, refer to the Bio-Rad
catalog or call Bio-Rad Technical Support.
P/N
RACKS
DESCRIPTION
93517
Standard sample racks (Rack code $T)
93518
Control rack (Rack code $2)
93519
Large reagent rack (Rack code $1)
93520
Size-adaptor for 15 ml reagent bottles (X 6)
90328
Tray for sample racks
90353
Barcode labels for alternative racks (U, V, W, Y, -3)
REAGENT BOTTLES
89776
Reagent bottle 15 ml (X 72)
89777
Reagent bottle 30 ml (X 72)
89778
Reagent bottle 60 ml (X 72)
89779
Reagent bottle 125 ml (X 72)
93516
Adaptor for 125 ml diluent bottles
402-5900
V-Vial Polypropylene reagent container 23 ml (X 500)
402-5820
Push caps for 23 ml V-Vial reagent containers (X 500)
CONTAINERS
89935
2-liter wash solution container, no cap, no tubing
91381
Ordinary cap for 2-liter wash solution container
89934
1-liter wash solution container, with cap, no tubing
89657
1-liter wash solution container, with cap and tubing (Red)
89661
2-liter wash solution container, with cap and tubing (Blue)
89662
2-liter wash solution container, with cap and tubing (Yellow)
93549
Tray for wash solution bottles
89984
System –liquid container, 10-liter
Spare liquid waste container with ordinary cap, no tubing, 10liter
Liquid waste container with cap and tubing, 10-liter
89985
89650
TIPS
89611
Small tips 300 µl (X 17280)
89612
Long tips 1100 µl (X 9600)
89799
Tip waste bag (X 10)
MAINTENANCE
1706531
TWEEN 20 for System-liquid preparation (100 ml)
89645
Rivascop Decontamination Solution (X 1 liter)
PE KIT (Pipettor - Washer Reagent kit for performance
evaluation)
89894
84
Last modification: 05 – 2008
User Manual Code: 93502-m-EN
A 2. Accessories and Consumables
EVOLIS Twin Plus Version 1.00 – User Manual
Barcode Labels for non-barcoded reagent bottles
Kit
P/N
Label Name
User-defined assay
89770
Evolis BC Labels UsDefin 1-5
User-defined assay
88451
Evolis BC Labels UsDefin 6-10
ANA Screen Test
88432
Evolis BC Labels ANA Screen
Anti-Centromere Test
88433
Evolis BC Lab Anti-Centromere
Anti-dsDNA
88434
Evolis BC Lab Anti-dsDNA
Anti-Jo-1 Test
88435
Evolis BC Labels Anti-Jo-1
Anti-Scl-70 Test
88436
Evolis BC Labels Anti-Scl-70
Anti-Sm Test
88437
Evolis BC Labels Anti-Sm
Anti-SmRNP Test
88438
Evolis BC Labels Anti-SmRNP
Anti-SS-A Test
88439
Evolis BC Labels Anti-SS-A
Anti-SS-B Test
88440
Evolis BC Labels Anti-SS-B
ENA(+) Screen Test
88441
Evolis BC Labels ENA(+) Screen
KALLESTAD™ Anti-TPO
97218
Evolis BC Labels KS Anti-TPO
KALLESTAD™ Anti-GBM
97219
Evolis BC Labels KS Anti-GBM
KALLESTAD™ Anti-dsDNA
97220
Evolis BC Labels KS Anti-dsDNA
KALLESTAD™ Anti-Centromere
97221
Evolis BC Lab KS Anti-Centrom
KALLESTAD™ Anti-Mitochondrial
97222
Evolis BC Lab KS Anti-Mitochon
KALLESTAD™ Anti-PR3
97223
Evolis BC Labels KS Anti-PR3
KALLESTAD™ Anti-MPO
97224
Evolis BC Labels KS Anti-MPO
KALLESTAD™ Anti-Tg
97225
Evolis BC Labels KS Anti-Tg
Platelia™ TOXO IgM TMB (72751)
88443
Evolis BC Labels Toxo-IgM
Platelia™ TOXO IgG TMB (72741)
88442
Evolis BC Labels Toxo-IgG
Platelia™ TOXO IgA TMB
97200
Evolis BC Labels Toxo-IgA
Platelia™ RUBELLA IgM TMB (72922)
88446
Evolis BC Labels RUBELLA IgM
Platelia™ RUBELLA IgG TMB (72912)
88445
Evolis BC Labels Rub-IgG
Platelia™ Aspergillus
88444
Evolis BC Labels ASPERGILLUS
Platelia™ Helicobacter pylori
90337
Evolis BC Labels H. pylori
Platelia™ M. PNEUMONIAE IgG TMB
97201
Evolis BC Lab M pneumo IgG TMB
Platelia™ M. PNEUMONIAE IgM TMB
97202
Evolis BC Lab M pneumo IgM TMB
Platelia™ CHLAMYDIA IgG TMB
97203
Evolis BC Labels CHLAMYDIA IgG
Platelia™ CMV IgG (72680)
97204
Evolis BC Labels CMV-IgM New
Platelia™ CMV IgM (72681)
97205
Evolis BC Labels CMV-IgG New
Platelia™ HSV (1 + 2) IgG
97206
Evolis BC Labels HSV-IgG
Platelia™ HSV (1 + 2) IgM
97207
Evolis BC Labels HSV-IgM
Platelia™ VZV IgG
97208
Evolis BC Labels VZV IgG
Platelia™ VZV IgM
97209
Evolis BC Labels VZV IgM
Platelia™ MEASLES IgG
97210
Evolis BC Labels Measles IgG
Platelia™ MEASLES IgM
97211
Evolis BC Labels Measles IgM
Platelia™ MUMPS IgG
97212
Evolis BC Labels Mumps IgG
Platelia™ MUMPS IgM
97213
Evolis BC Labels Mumps IgM
MONOLISA™ HBc IgM PLUS
88448
Evolis BC Labels HBc IgM PLUS
SYPHILIS TOTAL ANTIBODY (TA) EIA
89993
Evolis BC Labels Syphilis-TA
Genetic Systems™ HIV-1 Ag EIA
89991
Evolis BC Labels HIV-Ag
Platelia™ EBV-EA-D IgG
90271
Evolis BC Labels EBV-EA-D IgG
Platelia™ EBV-VCA IgG
90272
Evolis BC Labels EBV-VCA IgG
Platelia™ EBV-VCA IgM
90273
Evolis BC Labels EBV-VCA IgM
Platelia™ EB-NA-1 IgG
90274
Evolis BC Labels EB-NA-1 IgG
Last modification: 05 – 2008
User Manual Code: 93502-m-EN
85
A. Appendices
EVOLIS Twin Plus Version 1.00 – User Manual
Kit
Platelia new ToRCH panel including
Platelia™ Toxo IgG (72840)
Platelia™ Toxo IgM (72841)
Platelia™ Rubella IgG (72850)
Platelia™ Rubella IgM (72851)
Platelia™ CMV IgG (72810)
Platelia™ CMV IgM (72811)
Platelia™ HSV 1 IgG (72820)
Platelia™ HSV 2 IgG (72821)
86
P/N
97214
Label Name
Evolis BC Labels ToRCH
Last modification: 05 – 2008
User Manual Code: 93502-m-EN
A 3. Data Label
EVOLIS Twin Plus Version 1.00 – User Manual
A 3.
Data Label
EVOLIS Twin Plus
Typ XXXX
100V – 240V/ 3.2A – 1.3A/ 50Hz – 60Hz
Fuse 250 VAC, T4AH
REF
XXXXX
SN
XXXXXXXXXX
IVD
Bio-Rad
92430 Marnes-la-Coquette
France
2008-01
Figure 36: Data label
Symbols and abbreviations
V
Voltage (Power supply)
Hz
Frequency
A
Ampere
CE Marking (European Directive 98/79 CE on
in vitro diagnostic medical devices)
IVD
In vitro diagnostic medical device
Fuse rating
REF
Reference / Catalog number
SN
Serial number
Consult instructions for use
Manufacturer
Date of manufacture
WEEE
(European
Union
Directive
2002/96/CE on waste electrical and electronic
equipment – "WEEE Directive")
This product contains electrical or electronic
materials. Presence of this label on the product
means it should not be disposed of as
unsorted waste and must be collected
separately. Before disposal, contact your local
Bio-Rad representative for country-specific
instructions.
Last modification: 05 – 2008
User Manual Code: 93502-m-EN
87
A. Appendices
EVOLIS Twin Plus Version 1.00 – User Manual
A 4.
Symbols and Abbreviations
On the instrument
General hazard
Biohazard
Laser Beam Hazard
Electric Hazard
In this manual
See Typographical Conventions
See Typographical Conventions
Biohazard
APF
LIS
LIMS
LLD
OD
PC
NC
88
Assay Protocol Files
Laboratory Information System
Laboratory Information Management System – Same
as above: LIS and LIMS are used with an equivalent
meaning.
Liquid Level Detection
Optical Density
Positive Control
Negative Control
Last modification: 05 – 2008
User Manual Code: 93502-m-EN