EVOLIS Twin Plus User Manual EN (English)

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EVOLIS Twin Plus System

TM

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

1 System Overview.............................................................9
1.1 Instrument Description.......................................................................9
1.2 Software Overview ............................................................................11

2 Daily Routine Operation................................................13


2.1 Getting Started ..................................................................................13
2.1.1 Check Liquid Levels (Start-Up Maintenance) .....................................13
2.1.2 Start-Up ...............................................................................................14
2.2 Prepare and Load Samples ..............................................................16
2.3 Check and Validate the Worklist .....................................................18
2.4 Complete the Loading Process .......................................................22
2.4.1 Wash Solutions and Rinse Fluid .........................................................23
2.4.2 Dilution Plates (if any) .........................................................................23
2.4.3 Pipetting Tips ......................................................................................24
2.4.4 Reagents .............................................................................................25
2.4.5 Test Plates ..........................................................................................26
2.5 Run .....................................................................................................28
2.6 Run Results .......................................................................................29
2.6.1 Understanding / Validating Result Reports .........................................30
2.6.2 Export Results .....................................................................................32
2.7 End of Run .........................................................................................33
2.7.1 Unload / End of Run Maintenance ......................................................33
2.7.2 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

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Table of Contents
EVOLIS Twin Plus Version 1.00 – User Manual

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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IV User Manual Code: 93502-m-EN
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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User Manual Code: 93502-m-EN V
Typographical Conventions
EVOLIS Twin Plus Version 1.00 – User Manual

Typographical Conventions

Warning messages are indicated by this symbol and printed in bold-


face 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."

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VI User Manual Code: 93502-m-EN
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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Safety Instructions
EVOLIS Twin Plus Version 1.00 – User Manual

• 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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VIII User Manual Code: 93502-m-EN
1. System Overview
EVOLIS Twin Plus Version 1.00 – User Manual

1 System Overview

1.1 Instrument Description


➐ ➎


➑ ➍

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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10 User Manual Code: 93502-m-EN
1.2. Software Overview
EVOLIS Twin Plus Version 1.00 – User Manual

1.2 Software Overview

Main screen (Worklist)

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
<Scroll> (Page Up)
Parameters>

<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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12 User Manual Code: 93502-m-EN
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 Prepare system-liquid, Decontaminate waste container, see Section 3.20.

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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.


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

If the batch number printed on the kit package is not listed in the
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…>.

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20 User Manual Code: 93502-m-EN
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.



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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22 User Manual Code: 93502-m-EN
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)

Green Green Blue

➊ 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 Load a full tip rack with 96 X 1100 µl tips.
Gray Brown Red 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 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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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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28 User Manual Code: 93502-m-EN
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
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2.6.1 Understanding / Validating Result Reports

When using Bio-Rad predefined assays, the result report always includes
the following sections.

➊ ➐

➌ ➑


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:
• 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:
• 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).

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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 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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2.7.2 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.

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3. Advanced Information
EVOLIS Twin Plus Version 1.00 – User Manual

3 Advanced Information

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

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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 pre-
defined 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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3.2 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.

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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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3.3 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.

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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.

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
With calibrator vials included in most Bio-Rad kits.
height-adaptors

Special cases
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
Without sample tubes). Control transferred into tubes should not be loaded on
height-adaptors
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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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>.

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42 User Manual Code: 93502-m-EN
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. 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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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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3.5 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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46 User Manual Code: 93502-m-EN
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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3.7 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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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 Bio-
Rad 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

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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3.10 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 Bio-
Rad kits have removable strips, a 2-digit code is engraved on each
strip for easy identification.

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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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3.11 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 Bio-
Rad 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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3.12 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, Pressure monitoring flags. These flags can be reported only if the pressure
P_min_low, monitoring function is enabled. In case of recurring pressure monitoring
P_stop_high, flags, call Bio-Rad Technical Support.
P_static_high, P_max_high Aspiration pressure too high Clot
P_static_low, P_min_low Aspiration pressure too low Foam or air
P_mean_low 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

flagged (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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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 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.
Users 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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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 Bio-
Rad 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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3.20. General Maintenance Tasks and Maintenance Schedule
EVOLIS Twin Plus Version 1.00 – User Manual

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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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


Æ on Plate 1
CTRL CV Pipettor High Vol BR.asy
CTRL Washer Aspirate ETP BR.asy 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 Set-
up Panel dialog box.

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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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Maintenance Schedule

Daily Maintenance

Perform start-up maintenance (check liquid levels) See Section 2.1.1.

Perform end-of-day maintenance and shutdown the See Section 2.7.2.


system.

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 See Section 2.7.2.


system.

Clean the instrument surfaces and work areas See above General Maintenance Tasks.

Decontaminate the sample and reagent racks and the Prepare a decontamination solution consisting of 0.4 % (4 ml per
®
tip ejection slide. 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 See Section 2.7.2.


system.

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

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 Upon start-up (see Section 2.1.2), when In the upper toolbar, click the <Utilities>
the Selftest window). button, then select Selftest to reinitialize
one or more modules do not have a
the system.
"Passed" status.
If the problem persists, call Bio-Rad
Technical Support.
Yellow loading LEDs do not light up. When you intend to load sample or To re-activate the barcode scanner you
reagent racks and no LED is lit. 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. After clicking <OK> in the Load dialog <Retry>: the software checks the level
* Refill reagent bottle. box or during the run. sensor again.
One of the wash solution containers is <Abort>: the worklist will be aborted.
empty.
Refill the wash solution container and
click <Retry>.
If the error persists after refilling, call
Bio-Rad Technical Support.
[...] fatal error [...]: Waste full.\ During initialization procedure or during Check that the small washer waste
* Empty waste container the run. bottle "1" (located behind the wash
solution containers) has not accidentally
Malfunction of the small washer waste fallen and that the connecting tubing is
bottle "1" (located behind the wash not twisted or pinched.
solution containers).
If the bottle is more than half full, empty
(contaminated waste!), reconnect and
click <Retry>. If the error persists,
1 please call Bio-Rad Technical Support.
Decontaminate all liquid waste as
described in Section 3.20.

[...] fatal error: System fluid low. During the initialization procedure or Refill the system liquid container (see
* Refill the system fluid container. during the run. Section 3.20). When done, click <OK>.

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Problem / Message Circumstance / Possible cause Recommended actions


[...] fatal error: System waste full. During the initialization procedure or Replace the full waste container with an
* Empty the system waste container. during the run. empty one, reconnect and click <OK>.
Decontaminate all liquid waste as
described in Section 3.20.

A kit already exists with product When referencing a new kit lot. If you are scanning the barcode on a kit
code [...] and batch number [...]. box, this means that this kit lot has
* Please enter a unique product code already been referenced in the kit
and batch number. 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.
Are the metal plates inserted below The programmed run requires a dilution Make sure you have inserted a metal
the dilution/archive plates? plate to be loaded in a slot where a large plate under each dilution plate (see
diluent bottle was loaded in the previous Section 3.6).
run.
Are you sure you want to abort all of The run is paused and you have clicked Click <Yes> or <No> as required (see
the plates? the <Abort worklist> button Section 3.12).
(confirmation message).
Are you sure you want to ABORT The run is paused and you have clicked Click <Yes> or <No> as required (see
plate [...]? the <Abort plate(s)> button (confirmation Section 3.12).
message).
Are you sure you want to export You clicked the <Export results> button. See Section 3.17.
these results to file and/or LIMS?
Aspirate check failed in reagent [...]. During the run. Liquid level detection See Section 3.11.
error on reagent aspirate step.
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 [...]! During the run. When loading an unstable Check the position of the reagent bottle
* Ensure that the bottle with barcode reagent. on the rack (see Section 3.4).
[...] is positioned correctly.
Clot detected/Aspirate check failed During the run. See Section 3.11.
in [...].
Error on reagent aspirate step.
If the error persists, please call Bio-Rad
Technical Support.
Crash recovery file detected. After power failure. <No>: System is reinitialized. Old
Do you want to try and recover the worklist will be deleted. <Yes>: The
worklist? 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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Problem / Message Circumstance / Possible cause Recommended actions


Duplicate patient ID [...]! A manually entered sample ID is identical Check the manually entered sample ID.
* Edit the patient IDs so that only one to an existing sample ID. It is not possible to have the same ID for
tube is used per patient. two sample tubes.
Duplicate patient ID [...]. Two loaded sample tubes have identical Remove one of the sample tubes or use
* Remove patient tubes and verify barcodes. another barcode for one of the tubes.
which one should be used.
Error scheduling plate [...] The system is unable to program the Click <OK> and try and correct the
current worklist. This message is problem indicated in the first message.
generally displayed after another
message stating what the problem is.
Error! Barcode [...] is not correct for During the run. When refilling a reagent Check the position of the reagent bottle
reagent [...]. bottle. on the rack (see Section 3.4).

Error! Reagent [...] has not been During the run. The system prompted you If this message is displayed, you can still
loaded! to load a reagent (e.g. unstable reagent load the required reagent but you will
or reagent to be refilled) and the required need to check the results and the log file
reagent was not loaded within the preset carefully to see if the delay had an
time span. impact. If in doubt, discard the results
and retest the samples!
Expected barcode(s): '(list of all Lot tracking error. Load the correct reagent bottle (from the
reagent barcodes expected for that kit lot you have referenced in the kit
assay) [...]' database - see Section 3.4).
Scanned barcode: '(barcode of first
unexpected reagent)[...]'
Please check the barcode and retry.
Incorrect password. You entered a wrong password. Enter the correct password. Passwords
Try entering the password again. are case-sensitive! If you have forgotten
your password, see Section 3.18.

Insufficient volume of [...] detected. During the run. Volume of reagent is Please make sure that enough reagent
insufficient. liquid is available and click <Refill
bottle>.
Otherwise, click <Abort Plate>.
Insufficient volume of [...] for the During pre-run reagent volume check. Refill the specified reagent bottle.
worklist. Not enough reagent available in the
specified container.
Insufficient volume of [...], position During pre-run wash solution volume Refill the specified container with the
[...], for the worklist. check. Not enough wash solution required wash solution.
available in the specified container.
Lot number [...] does not exist! Lot tracking error. The scanned lot Scan the correct lot number or update
number does not exist. 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 Load more tips (see Section 3.7).
available.
No information could be found for Lot tracking error. The scanned kit Enter the correct product code.
product code [...]. barcode or the product code you entered
does not exist.
No kit information can be found for Lot tracking error. The batch number Enter the correct batch number or
this batch number. does not exist in the kit database. update the kit database.
No liquid detected for [...] During the run. No liquid for reagent ... is Fill or reload a bottle of the required
detected (this message is displayed only reagent and click <Refill bottle>.
if pre-run reagent volume check is
disabled). Otherwise, click <Abort Plate>.

Note: The current worklist has been Continuous loading. The system allows See Section 3.13.
paused. you to reload now.
Press the 'Start' button when you are
ready to proceed with the new
worklist.

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Problem / Message Circumstance / Possible cause Recommended actions


Patient IDs: [...] are being run using Some of the samples in your worklist will Click <Yes> if this is intentional.
the same assay protocol multiple be tested twice with the same assay Otherwise click <No> and review the
times! (multiple selection). worklist definition.
Are you sure you want to proceed?
Pipette error [...] - pipetting step was Successful execution of the pipetting step Affected samples will be flagged: PipErr.
not confirmed. could not be confirmed. Please call Bio-Rad Technical Support.
Pipettor error 0x70 - Disposable tip The pipettor accidentally looses the tip Available recovery options are <Retry>
dropped [...]. during a pipette or dispense step. or <Abort Plate>. If you click <Retry>,
* Please remove the tip from the the pipettor picks up another tip and
system. 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 Pipettor crash during a run. Common Case 1) Try to correct the cause of the
loop/overload error [...]. causes: crash (bent tube, reagent cap…) and
click <Retry>.
1) Crash in z direction, e.g. onto the rim
of a bent tube or forgotten reagent cap. Case 2) Pipettor hardware may be
damaged and must be checked.
2) Horizontal crash, e.g. against an
obstacle left on the worktable. 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 When using Bio-Rad predefined assay
worklist. files, this error occurs only if the APF
files have not been correctly installed.
Call Bio-Rad Technical Support.
Reagent [...], barcode [...], was not The reagent you loaded is not referenced Click <OK> to close the message.
found in the kit database. at all in the kit database. 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 Unreadable sample barcode. See Section 3.3.
incorrectly. If you choose to
continue then the affected samples
will be flagged.
Continue anyway?
Some required resources have not When clicking <OK> to close the Load See Section 3.4.
been allocated to system positions! dialog box. At least one required reagent
remains in the Unallocated resources
corner.
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

Strip/well verification error! When loading microplates. Add the missing strips or wells (see
* Please ensure that a well has been Section 2.4.5).
inserted into the plate for each assay The microplate you loaded includes an
as shown in the plate load dialog incomplete strip or not enough strips.
box.

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Problem / Message Circumstance / Possible cause Recommended actions


Suspect tip pick-up During tip pick-up, the pipettor cannot After the error occurs the software goes
move deep enough into the tip and the tip on with the next tip automatically.
is not correctly attached.
If the error persists, the pipettor has to
be checked. Call Bio-Rad Technical
Support.
System fluid LOW. Not enough system-liquid available. Refill the system-liquid container (see
Section 3.20).

System waste FULL. The main liquid waste container is almost Replace the full waste container with an
full. empty one, reconnect and click <OK>.
Decontaminate all liquid waste as
described in Section 3.20.

The disposable tips have been During the tip type detection. System After you have clicked <OK> the
incorrectly loaded. detected large tips instead of small tips or software displays the Load dialog box
vice-versa. 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 After deleting a forgotten password. See Section 3.18.
cleared.
They should set a password when
they next log on.
The pipettor is currently busy. The When trying to reload tips during a run. Click <OK> to close the message and
pipettor shall need to be paused try again when the pipettor is inactive
whilst additional tips are loaded. (check the Schedule view of the
Are you sure you want to load worklist).
additional tips now?
The rack has not been positioned in When loading the large reagent rack. See Section 3.4.
the sample rack in a manner Because of the grid above the sample
compatible with the grid. and reagent unit, the large reagent rack
* Please replace the rack in another can only be loaded on certain tracks.
track.
The rack in track [...] is not the same Rack changed during refill bottle or Load the correct rack.
as was originally loaded! unstable reagent loading process.
* Please load rack [...] in track [...].
The reagent ID [...] is already in use This reagent ID is already in the kit Enter a unique reagent ID.
for this kit. Please enter a unique database.
reagent ID.
The system is already running You clicked the <New Worklist> button If you want to add more samples/ plates
another worklist. while the current worklist was not yet to a running worklist, please follow the
Please wait until that worklist has finished. continuous loading procedure described
finished. in Section 3.13.

The worklist cannot be started Kit lot tracking error. The worklist cannot Check that you have correctly
because some reagents have an be started until the error(s) have been referenced the kits in the kit database
incorrect barcode. corrected. (see Section 3.4) and that you have not
* Check and reload the reagents.
exchanged reagent bottles between
different kit packages.
The worklist is currently active. You tried to close the worklist window or Click <No> and wait until the end of the
Are you sure you want to close this to close the software while the current run. If you want to abort the worklist, see
window? worklist is not finished. Section 3.12.

These results have already been You tried to export results that have See Section 3.17.
exported to the LIMS. already been exported.
Are you sure you want to export
them again?
This will delete all patient In the Patient Editor, you clicked the Unless you specifically want to delete all
information and test requests! This <Delete All> button. patient information and test requests, it
action cannot be undone! is recommended to use the <Delete
Are you sure you want to delete all (date)> aor the <Delete (Test)> buttons
patient information? instead of <Delete All>.

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Problem / Message Circumstance / Possible cause Recommended actions


Tip eject failure. The disposable tip could not be correctly Remove the tip manually, then click
* Remove the tip from the pipettor. ejected from the pipettor after use. <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 This error normally occurs only when Click <OK> to override the error
model. Check that there are opening a result file (*.res) on a separate message and open the result file.
sufficient standards. computer (not the integrated system
computer).
Unable to schedule the assay. Assay requires hardware that is not Edit worklist to delete the plate.
Possible reasons: installed or more plate carriers that can
* No hardware found capable of be processed by the system.
executing the assay instructions.
* No plate carrier available.
Unable to store control file [...]. This error normally occurs only when Click <OK> to override the error
opening a result file (*.res) on a separate message and open the result file.
computer (not the integrated system
computer).
Warning! Reagent [...] has expired! The expiry date of the reagent you loaded Click <OK> to close the message. You
(Expiry date [...].) 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 You do not have sufficient access rights See Section 3.18.
this action. to perform this action.
Please ask a supervisor for
assistance.
You cannot cancel this operation Continuous loading error. For continuous loading, follow the
because a new worklist has already procedure described in Section 3.13. To
been scheduled. You must either
load or delete the additional plates. abort some plates, see Section 3.12.

You will be able to add plates in [...] During continuous loading, you have to See Section 3.13.
minutes. Please try again then. wait until all current plates are incubating
to add new plates.

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A. Appendices
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A. Appendices

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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A. Appendices
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A 1. Technical Specifications

Dimensions & Weight


Instrument size (H x W x D) 115 x 125 x 90 cm
Instrument weight (without accessories) 100 kg

Electrical
Voltage 100V - 240V
Frequency 50 - 60 Hz
Power consumption 320 VA (mean)
Fuse rating 4 AT

Operating conditions
General Indoor use only.
No direct sunlight (may mislead
optical sensors and affect
performance)
Temperature 15 - 30 °C
(storage 5 - 50 °C)
Humidity 30 - 80 % (non-condensing)
(storage 10 - 85 % non-condensing)
Altitude < 2000 m above sea level
Noise level 70 dB (A) at 1 m
Pollution degree 2
Installation class 2

Sample processing
Primary sample capacity 144
Dilution capacity (via tubes/plate) 72/192
Container (diameter & height) 10-16 mm/50-100 mm
e
Sample dilution up to 1/10,000

Reagent processing
Calibrators & controls capacity 16
Reagents capacity 16
Reagents containers Bio-Rad reagent bottles
Reagents identification internal BCR
Lot & expiration management yes

Disposable tips
Carbon tips 300-1,100 μl
Volume (useable) 10-1,000 μl
Liquid level & clot detection capacitive + air pressure
On-board capacity (walk-away) 288 tips (3 x 96)

Processing features
Patient samples (100 μl/well) ~ 16 min/full plate
Reagent (100 μl/well) ~ 4 min/full plate
Dilution (1:10) ~ 23 min/full plate
Single dispense Multi-dispense
Precision (at 20 μl) < 6% CV < 10% CV
Accuracy (at 20 μl) < 10% < 10%
Precision (at 100 μl) < 3% CV < 5% CV
Accuracy (at 100 μl) < 5% < 5%

Incubation specifications
Number of incubators 3 x ambient T
2 x from ambient T +5°C, up to 50°C
Temperature Precision 1.4°C
Temperature Accuracy ± 1.0°C

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Washer specifications
Manifold 8 channels
Plate type (bottom shape) flat, U- & V-shaped
Wash buffers 2 x 2 l, 1 x 1 l

Photometer specifications
Reading head 8 channels
Reading range 0-3.5 OD
Filter wheel 8 (equipped with 450, 492, 620)
Linearity (0-2.0 OD) 1%
Precision (0-2.0 OD) 2.5%

Communication
Communication Port RS-232 Serial, USB 2.0, RJ-45
On-line (bi-directional) ASTM or ASCII format

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A. Appendices
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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 DESCRIPTION
RACKS
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, 10-
89985
liter
89650 Liquid waste container with cap and tubing, 10-liter
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
89894
evaluation)

Last modification: 05 – 2008


84 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 P/N Label Name


Platelia new ToRCH panel including 97214 Evolis BC Labels ToRCH
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)

Last modification: 05 – 2008


86 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 2008-01
France

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 Assay Protocol Files


LIS Laboratory Information System
LIMS Laboratory Information Management System – Same
as above: LIS and LIMS are used with an equivalent
meaning.
LLD Liquid Level Detection
OD Optical Density
PC Positive Control
NC Negative Control

Last modification: 05 – 2008


88 User Manual Code: 93502-m-EN

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