EVOLIS System

User Manual

0001387-EN (Instrument) 89601

V2.4-2109-1

Revision of the manual: September 2021 – English

Software version: 2.4
We reserve the right to make changes in the course of technical development without prior
notice.

Copyright - Software
The software for the EVOLIS analyzer has been licensed to Bio-Rad for
worldwide distribution. The EVOLIS software is the intellectual property of
STRATEC SE. Intellectual property rights shall remain with STRATEC SE.

You are entitled to use the EVOLIS software at your place of work only.

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.

Trademarks
BIO-RAD is a trademark of Bio-Rad Laboratories, Inc.
EVOLIS is a trademark of Bio-Rad Europe, GmbH in certain jurisdictions.
All trademarks used herein are the property of their respective owner.

Warranty
The EVOLIS analyzer and associated accessories are covered by a
standard Bio-Rad warranty. Contact your local Bio-Rad Laboratories office
or reseller for the details of the warranty.

Bio-Rad User manuals (eIFUs) for Bio-Rad's Infectious

3, boulevard Raymond Poincaré Disease instruments are available for download
92430 Marnes-la-Coquette - France from downloads.bio-rad.com.

Phone: +33 (0)1 47 95 60 00

Fax: +33 (0)1 47 41 91 33
 Table of Contents
EVOLIS Version 2.4 – User Manual

Table of Contents

About This Manual ............................................................................................... V

Bio-Rad Technical Support .................................................................................. V
Typographical Conventions and Abbreviations .................................................. VI
Safety Instructions ............................................................................................. VII
Warning Labels ................................................................................................... IX

1 System Overview ........................................................... 11

Intended Use ......................................................................................11
User Profile ........................................................................................11
Instrument Description .....................................................................13
Software Overview ............................................................................16
Installation .........................................................................................18
1.5.1 First Login............................................................................................19
1.5.2 Files Types and Default Directories ....................................................22

2 Daily Routine Operation................................................ 24

Getting Started ..................................................................................24
2.1.1 Check Liquid Levels (Start-Up Maintenance) .....................................24
2.1.2 Start-Up ...............................................................................................25
Prepare and Load Samples ..............................................................27
Check and Validate the Worklist......................................................29
Complete the Loading Process .......................................................33
2.4.1 Wash Solutions and Rinse Fluid .........................................................34
2.4.2 Dilution Plates and Diluent (if any) ......................................................35
2.4.3 Pipetting Tips.......................................................................................36
2.4.4 Reagents .............................................................................................37
2.4.5 Test Plates ..........................................................................................38
Run .....................................................................................................40
Run Results .......................................................................................42
2.6.1 Understanding / Validating Result Reports .........................................43
2.6.2 Export Results .....................................................................................45
End of Run .........................................................................................46
2.7.1 Unload / End of Run Maintenance ......................................................46
2.7.2 Log Off.................................................................................................47
2.7.3 Shutdown / End of Day Maintenance ..................................................48

3 Advanced Information................................................... 49
Assays ................................................................................................50
Barcodes ............................................................................................52
Samples..............................................................................................55
Reagents and Controls .....................................................................57

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Table of Contents
EVOLIS Version 2.4 – User Manual

Non Bio-Rad Kits ...............................................................................67

Dilution Plates and Diluents.............................................................68
Pipetting Tips.....................................................................................70
Logs ....................................................................................................71
Schedule ............................................................................................73
Multi-Assay per Plate ........................................................................74
Pipetting Errors .................................................................................76
Pausing a Run / Emergency Stop ....................................................78
Continuous Loading .........................................................................79
Flags ...................................................................................................81
Recalculate Results ..........................................................................83
Network Connection and Cybersecurity .........................................85
Import .................................................................................................88
Export .................................................................................................90
User Management .............................................................................91
3.19.1 Windows User Groups and Access Rights .........................................91
3.19.2 EVOLIS User Groups and User Access Rights ..................................92
3.19.3 Password Management ......................................................................95
Demo Mode ........................................................................................97
General Maintenance Tasks and Maintenance Schedule .............98
Software Maintenance ....................................................................105
Disposal of an EVOLIS System......................................................108

4 Troubleshooting .......................................................... 109

A. Appendices .................................................................. 117

A 1. Technical Specifications ................................................................118
A 2. Accessories and Consumables .....................................................121
A 3. Data Label ........................................................................................124
A 4. Flags .................................................................................................125
A 5. Revision History ..............................................................................126

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 About This Manual
EVOLIS Version 2.4 – User Manual

About This Manual

Important Notice
This manual contains all information needed:
 to operate the EVOLIS 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 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.

A revision history showing the changes made to this manual compared to the
previous version can be found in Appendix A 5.

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.

Your EVOLIS system can also be connected to Bio-Rad's remote instrument

monitoring and support system (BRiCare). This completely safe system allows
Bio-Rad Technical Support to gain access (with your permission only!) to your
system remotely and solve any problems much faster. To know more about
this possibility, please ask your local Bio-Rad Technical Support.

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Typographical Conventions and Abbreviations
EVOLIS Version 2.4 – User Manual

Typographical Conventions and Abbreviations

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.

Software terms Names of software windows, menus and buttons are printed in bold type.
Examples: Open the Worklist window.
Select the File menu.
Click the Save button.

(numbered lists) 1. Numbered lists identify sequences of actions to be performed by the

operator.

Software messages 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."

Abbreviations used in this manual

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

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 Safety Instructions
EVOLIS Version 2.4 – User Manual

Safety Instructions

EVOLIS is a fully automated microplate analyzer including functions such as

sample preparation, test performance, photometric measurement and data
evaluation.

EVOLIS 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 Version 2.4 – 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.

For a patient/user/third party in the European Union and in countries

with an identical regulatory regime (Regulation 2017/746/EU on in vitro
diagnostic medical devices); if, during the use of this device or as a
result of its use, a serious incident occurs, please report it to the
manufacturer and to your national competent authority.

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 Warning Labels
EVOLIS Version 2.4 – User Manual

Warning Labels

A number of warning labels are positioned on the EVOLIS System

itself. These are described in the table below.
Before using the system, please take time to check that all labels
described in the table are actually present on your EVOLIS System. If
some labels are missing or unreadable, please call Bio-Rad Technical
Support. Missing or unreadable labels will result in unidentified risks.
They must be replaced.
After confirming the presence of all labels, please take time to read the
explanations below carefully and understand the risks associated with
all instrument areas and components signaled by these warning labels.
If you have any doubt about why a warning label has been positioned
on a specific area or component of the system or about what you are
supposed to do, or not do, in relation to a warning, please request the
assistance of your laboratory supervisor. Further explanations can
also be obtained from Bio-Rad Technical Support.

Label Meaning Location on the instrument *

General warning General warning labels are positioned:
Identifies potentially dangerous elements, • on the back panel (2) *, waste and system
e.g. do not lean on, do not disconnect, liquid connectors,
handle with care… • on the door of the samples and reagents
loading unit (1),
• on the door of the microplate loading
compartment (1).

Biohazard Biohazard labels are positioned:

Identifies zones or components that may be • on the tip waste container (1),
contaminated and are potentially infectious. • on the waste liquid container (1),
Strictly follow all local and national • on the washer manifold (1),
provisions, legislation and laboratory • on the small washer aspiration bottles (2)
regulations on using or handling (located in the drawer),
biohazardous equipment or material.
• on the tip ejection cover (1).
Improper use or handling may result in
severe contamination of the user and/or the
environment.
Cut injury hazard A cut injury hazard label is positioned:
The needles of the washer manifold are • on the washer manifold (1).
sharp and may be contaminated! Avoid
handling the manifold unless absolutely
necessary. If unavoidable, wear cut-resistant
gloves and operate carefully to prevent
potential injuries to hands.

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Warning Labels
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Label Meaning Location on the instrument *

Electrical hazard An electrical hazard label is positioned:
Do not touch the power switch with wet • on the back panel, next to the main power
hands. Turn off the instrument before you connector/switch (1) *.
disconnect the power cord.
End-users must not otherwise interfere with
electrical components.
Laser beam hazard A laser beam hazard label is positioned:
Looking directly into a laser beam may cause • next to the loading bay barcode scanner (1).
eye injuries / irritations.
Never look directly into the laser beam. Do
not use devices such as mirrors or mirroring
objects (watches, jewelry…) within the
trajectory of the laser beam.
A class 2 laser is used.

* A wildcard character signals labels located on parts of the instrument which

may not be directly accessible to end-users.

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 1. System Overview
EVOLIS Version 2.4 – User Manual

1 System Overview

Intended Use

The EVOLIS system is a fully automated ELISA (Enzyme-Linked

Immunosorbent Assay) microplate analyzer. The instrument is controlled via
a Windows-based software specifically designed and developed for this
purpose. The EVOLIS system is an in vitro diagnostic medical device.

The EVOLIS system is able to perform the complete sample processing

(including sample and reagent barcode identification, sample pre-dilution,
sample and reagent dispensing, incubations, wash processes, plate transport)
as well as photometric reading, and quantitative and qualitative calculation of
results.
The analyses are performed according to pre-defined assays supplied by Bio-
Rad for use with Bio-Rad reagent kits. The EVOLIS software also allows
users to define their own assays for use with non-Bio-Rad reagents provided
they have received adequate training.

The EVOLIS system includes the ability to import worklists from the LIS
(Laboratory Information System) and export results to the LIS (bidirectional
communication).

User Profile

When using an EVOLIS system, user profiles and access rights are defined
at two levels:
 Access rights for the Windows environment.
 User rights in the EVOLIS software.

Windows environment
Under default settings, three pre-defined Windows user categories and four
pre-defined user accounts are available on the computer provided by Bio-Rad
with the EVOLIS system:

User categories User accounts

"User"
Standard user "Evolis"
(This account is strictly reserved for Bio-Rad.)
Local administrator "local_admin"

Administrator (This account is strictly reserved for Bio-Rad.)

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1. System Overview
EVOLIS Version 2.4 – User Manual

The Windows "Standard user" category is intended for all groups of EVOLIS
software users.
The Windows "Local administrator" category is intended for the laboratory's IT
Specialist.
The Windows "Administrator" category is strictly reserved for Bio-Rad
authorized personnel.

EVOLIS software
Under default settings, two pre-defined user groups are available in the
EVOLIS software:
 Supervisors,
 Users.

The "Supervisors" user group is intended for lab managers and senior
laboratory personnel. The supervisor is a trained biologist with several years
of experience in the field of infectious disease diagnostics. At least one
"Supervisor"-level user is required per system (or per site if several systems
are installed on the same site). If the system is used as intended, this person
is able to recognize and avoid dangers.
The supervisor is able to instruct routine users on assay protocols in
connection with Bio-Rad products within the bounds of the intended use.

The "Users" user group is intended for routine users of the system. When
installing the system, Bio-Rad Technical Support will pre-set the access rights
of this group in accordance with the requests of the lab manager. Similarly, if
additional user groups need to be created (e.g. "Advanced users",
"Trainees"…), Bio-Rad Technical Support will define the corresponding
access rights in accordance with the requests of the lab manager. All these
users operate under the supervision and responsibility of the lab manager.

It is always the lab manager's responsibility to make sure that each

operator is assigned to a user group which corresponds to his/her
skills and level of technical training.
Bio-Rad assumes no liability for cases in which insufficiently skilled /
trained users, whether fraudulently or otherwise, made use of access
rights normally reserved for "Supervisor"-level users.

For more information on user management, see Section 3.19.

For more information on the laboratory's IT Specialist's role, see Section
3.19.1.

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 1.3. Instrument Description
EVOLIS Version 2.4 – User Manual

Instrument Description

➓
➋

➊ ➎ ➏
➌ ➍

➐ ➑
➒

Figure 1: System Overview - Outside

Computer
System cover
Tip racks and dilution plates loading drawer
Sample and reagent loading unit
Tip evacuation slide & tip waste bag
Microplate loading compartment
Lower drawer (washer, incubators, and photometer)
Washer viewing window
Cooling unit (optional)
Power switch on rear panel (not visible)

For full technical data (size, weight, electrical specifications...), see

Appendix A 1.
Warning labels on the instrument are explained in the Warning Labels
Introductory Section.

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1. System Overview
EVOLIS Version 2.4 – User Manual

Figure 2: System Overview - Inside

Pipettor and pipetting arm

Dilution area (dilution plates and diluents)
Tip rack loading area
Sample and reagent unit
Microplate pipetting zone
Tip ejection station
Photometer
Washer, wash solution containers, and small washer bottles
Incubators (4) and room-temperature light-protected incubators (4)
Plate transport module
Lower drawer safety catch

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 1.3. Instrument Description
EVOLIS Version 2.4 – User Manual

Opening /closing the instrument cover

Always use the handle to open and close the instrument cover to avoid
damaging or twisting the cover.
The cover is locked during a run. Do not attempt to force it open as this can
cause a CovOp (Cover open) flag (see Section 3.14) even if the cover is not
actually opened.
The run cannot start if the cover is open or not properly closed.

Opening / closing the instrument lower drawer

The bottom drawer has two opening positions. In standard everyday use, the
drawer only needs to be opened up to its first opening position: this enables
the operator to load, unload or refill the wash solution containers (see Section
2.4.1) and perform standard maintenance tasks.
The second opening position allows the operator to access the rear part of the
drawer. This is necessary only in limited circumstances (e.g. to clean-up
severe spills...).
This is why, in normal use, a safety catch stops the drawer from being opened
all the way up to this second position. The safety catch is located on the left-
hand side of the drawer, behind the wash solution containers. Move it to the
right to unlock it.

Figure 3: Unlocking the safety catch

When opening the bottom drawer, pull evenly with both hands, one on each
side of the drawer. When closing the bottom drawer, push evenly with both
hands, one on each side of the drawer until you hear it click. Both sides should
be properly clicked in, otherwise the system cannot lock the drawer and the
run cannot start.

When the bottom drawer is open, strictly avoid leaning on it. The
drawer and/or the instrument may tip over!

Mechanical hazard - If additional wash solution is required during a

run, a message will be displayed and the system will unlock the lower
drawer to allow you to load the solution. The instrument is paused but
if the plate transport module, on the right hand side of the drawer (see
number on Figure 2), was in the process of moving a plate, it will
bring the plate to its scheduled destination before stopping.
Please be careful and wait until all movement has stopped before
opening the drawer.

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1. System Overview
EVOLIS Version 2.4 – User Manual

Software Overview

Main screen (Worklist)

Figure 4: Software Overview

Main toolbar
Worklist tree
Worklist display area

Toolbar icons

New Lot Specific Information

New Worklist Start
Open Stop
Save Load Tips
Print Backup
Import (non-functional icon)
System Maintenance (non-functional icon)

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 1.4. Software Overview
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Tree and display area

The "Tree and display area" layout is used in the EVOLIS software's most
important windows:
 worklist windows,
 assay windows,
 result windows.

Click the plus sign (+) next to the folder at the top of the tree to expand it.
Click an item in the tree to view its contents in the display area on the right-
hand side of the screen.
Click the Print toolbar button to print the contents of the display area. For
assay files and result files, selecting the top folder and clicking Print prints the
whole assay or the whole result report. Selecting an item in the tree and
clicking Print prints only the description of this individual item (assay step or
section of the result report). For worklists, only individual items can be printed:
e.g. select Reagent requirements and click Print to print the Reagent List
(see Figure 19).

Language of the EVOLIS software user interface

The EVOLIS software is currently available in the following languages:
English, Chinese, Czech, French, German, Hungarian, Italian, Japanese,
Polish, Portuguese, Romanian, Russian, and Spanish.

To change the language of the user interface:

1. Start the EVOLIS software but then select File | Close to close all open
windows.
2. Select the Utilities | Select Language menu item (if you cannot see the
Select Language menu item, make sure you have closed all open
windows as indicated in Step 1 above). This opens the Select Language
dialog box.
3. In the Select Language dialog box, use the drop-down list to select the
required language and click OK.
5. Restart the EVOLIS software.

If you performed the above procedure but the EVOLIS software remains in
English, please call Bio-Rad Technical Support.

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1. System Overview
EVOLIS Version 2.4 – User Manual

Installation

The EVOLIS system, including the EVOLIS computer and the EVOLIS
software, is installed by authorized personnel specifically trained by Bio-Rad.

End-users are not allowed to install the EVOLIS system themselves.

The EVOLIS computer must not be replaced by another computer.

The installation procedure includes the precise teaching of several modules

(pipettor, plate transport…). This is why, once an EVOLIS system is installed,
it must not be moved, even within the same laboratory, without the assistance
of Bio-Rad Technical Support.

All upgrades, including software upgrades, must be performed by Bio-Rad

Technical Support.
Installation on the EVOLIS computer of any third-party software not approved
by Bio-Rad is not permitted (for anti-virus software, see Section 3.16).

Screen savers or energy-saving automatic shut-off options on the

EVOLIS computer must be disabled as they may interfere with the
EVOLIS scheduler and affect the run.

Environmental conditions
The laboratory in which the EVOLIS system is installed must comply with the
environmental requirements (temperature, humidity…) listed in Appendix A 1
Technical Specifications.

Physical security
Your EVOLIS system should be located in a secure area. Non-lab personnel
should not be given physical access to your EVOLIS system. Your EVOLIS
system should not be left unmonitored for extended periods of time.

LIS Connection and cybersecurity

If your EVOLIS system is intended to be connected to the LIS (Laboratory
Information System), Bio-Rad Technical Support will collaborate with your
laboratory's IT Specialist to set-up and test the connection (see Section 3.16).

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 1.5. Installation
EVOLIS Version 2.4 – User Manual

1.5.1 First Login

The following procedure is to be performed by the lab manager with

the assistance of Bio-Rad Technical Support and under the
responsibility of the laboratory's IT Specialist (if different from the lab
manager - see Section 3.19.1).

The first login involves setting up user accounts and passwords both for
Windows and for the EVOLIS software.

The Windows "User" user account will be common to all operators of

the EVOLIS system within the lab.
Each laboratory must ensure the confidentiality of the password for the
Windows "User" account.

For the EVOLIS software, an individual user account must be created

for each person who will be authorized to use the EVOLIS system.

1) Windows first login

1. Start the EVOLIS computer by pressing the computer's ON/OFF switch.
Wait until the Bio-Rad logo is displayed in the center of a black screen.
Press any key on the keyboard. A Windows login prompt is displayed.

User

Figure 5: Windows first login

2. Enter "User" as user name in the top field. Do not enter anything in the
lower field (Password). Press Enter on the keyboard.
3. A message is displayed stating: "Your password has expired and must
be changed". Click OK.
4. In the next window, enter a password for the "User" user account,
confirm it and press Enter on the keyboard. This password must include
at least 8 characters.
5. A message is displayed stating: "Your password has been changed".
Click OK. The EVOLIS background window is displayed.

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Figure 6: EVOLIS Welcome screen

2) EVOLIS software first login

1. When the EVOLIS background window is displayed, start the EVOLIS
software by double-clicking the EVOLIS desktop icon.

2. The EVOLIS startup screen with the Log-On dialog box is displayed.
3. In the Log-On dialog box:
-- Bio-Rad Technical Support will have predefined a Supervisor-level
user account for the lab manager. In the User Name field, enter the user
name corresponding to this account.
-- Leave the Password field blank.
-- Select the Demo mode checkbox.

Figure 7: EVOLIS First login

4. Click OK. The Selftest window is displayed.

5. In the Selftest window, select the Utilities | Options menu item to open
the Options dialog box.
6. In the Options dialog box, go to the Password tab.

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 1.5. Installation
EVOLIS Version 2.4 – User Manual

Figure 8: EVOLIS Password registration

7. In the Password tab:

-- In the User Name field you should see the user name you entered
yourself in Step 3 above.
-- Leave the Current Password field blank.
-- Enter a personal and confidential password in the New Password and
again in the Retype Password fields (on password formats, see Section
3.19.3).
8. Click the Change button to save your new password, then click OK to
close the Options dialog box.
9. Select File | Exit to close the EVOLIS software.

As lab manager, you can now create a personal EVOLIS user account for
each person who will be authorized to use the EVOLIS system, as described
in Section 3.19.2 (if this has not been already done by Bio-Rad Technical
Support).
After that, each of these users will have to set-up their personal password as
described in the above procedure.

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1. System Overview
EVOLIS Version 2.4 – User Manual

1.5.2 Files Types and Default Directories

Under default settings the "Evolis.exe" file is installed in the following

directory:
"C:\BioRad"
and the basic software structure is as follows.

Figure 9: EVOLIS Software structure

Directory File Types

Backup Backup files (see Section 3.22).
Export Export files (see Section 3.18).
Import Import files (see Section 3.17).
Resources\Apf Assay files (see Section 3.1).
Resources\Event_log Log files (see Section 3.8).
Resources\Result Result files (see Section 2.6.1).
System System files.

These directories and files are not protected against manual deletion!
It is therefore essential to warn all users of the EVOLIS system against
manually editing or deleting them, even accidentally (particularly the
files stored in the "BioRad" and the "System" directories).

If you want to change this subdirectory structure, for example if you want to
send export files to a specific folder, do not edit folder names directly in
Windows Explorer. You need to edit the default paths and folders for each file
type from within the EVOLIS Software.
This customization is generally done by Bio-Rad Technical Support,
according to the instructions of the lab manager and of the laboratory's IT
Specialist, when installing the EVOLIS system.
If you still need to modify the subdirectory structure at a later stage, please
follow the procedure below. If in doubt, call Bio-Rad Technical Support before
making the change.

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 1.5. Installation
EVOLIS Version 2.4 – User Manual

1. Start the EVOLIS software by double-clicking the EVOLIS desktop icon

and log-in in Demo mode (see Section 3.20).

2. Select the Utilities | Options menu item to open the Options dialog box.
In the Options dialog box, go to the Directories tab.

Figure 10: Editing default directories

3. In the Directories tab, select the file type for which you want to edit the
default path/target directory and click Browse…. This open Windows
Explorer.
4. In Windows Explorer, navigate to the directory that you want to define as
new target directory for this file type. Select any file in this directory and
click Open.
Note: If the target directory is currently empty, do a right mouse click and
create an empty new *.txt document just to be able to select a file. You
can delete it later.
5. Back in the Directories tab, check that the default path for this file type
has been changed and click OK to close the Options dialog box.

Any unwarranted modifications to the EVOLIS computer or software

will void the warranty and service contract with Bio-Rad.

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2 Daily Routine Operation

Getting Started

Always wear adequate personal protective equipment: laboratory coat,

gloves and eye protection.
Always follow Good Laboratory Practices.

2.1.1 Check Liquid Levels (Start-Up Maintenance)

➊ ➋

Figure 11: 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. Deionized water is used as system-liquid.
2. Make sure the liquid waste container is empty and connected to the
system.

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 Refill system-liquid, Decontaminate waste container, see Section 3.21.

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2.1.2 Start-Up

1. Make sure the instrument cover is closed; switch on the system with the
switch located on the rear panel (when facing the instrument, you reach
the switch from the left-hand side, see Figure 1).
2. Switch on the computer, log in to the Windows predefined "User"
account and double-click on the EVOLIS icon to start the EVOLIS
software.

If you cannot see the EVOLIS icon on the desktop, this means that the
Windows account which you used when starting the EVOLIS
computer is not the account which was used to install the EVOLIS
Software. Please request first the assistance of your usual IT
specialist. If the problem persists, call Bio-Rad Technical Support.

3. The Log-On dialog box is displayed.

Figure 12: Logging in

4. Enter your user name and password and click OK.

5. The instrument initializes and all modules are checked. At the end of the
initialization process the Selftest window is displayed.

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Figure 13: Self-Test window

If all instrument modules have a "Passed" status, you can safely start working
with the system.

See also Users and passwords, see Section 3.19.

Demo Mode, see Section 3.20.
Incorrect password, see Section 4.
Initialization failure, see Section 4.

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Prepare and Load Samples

Check visually the quality of the samples you are intending to process
(no clots, no 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 system.
3. Make sure all barcode labels face right.

4. Open the door of the samples and reagents unit. At the back of the unit,
one of the red LEDs should be lit.

5. Take the first sample rack you want to load and insert it on the track
marked by this red 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, the LED for the next track lights up.
If the rack has not been correctly read, 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 14: 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 displayed in the upper drop-down
lists. Checkmarks show which tests are selected for each loaded sample. If

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there are no checkmarks and/or no tests displayed in the upper drop-down

lists, see Section 3.17.

7. Make sure all sample IDs have been correctly read.

8. Click the Close button to close this dialog box.
On the EVOLIS system, another 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 3.17.

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Check and Validate the Worklist

Whenever you load patient samples corresponding to imported test requests,

as described above, the system automatically suggests an appropriate
worklist. All you need to do is to check and validate this worklist.

1. In the upper toolbar, click the New Worklist button. This opens the Set-
up Panel dialog box showing the worklist automatically suggested by the
system.

➊
➋

Figure 15: Check Worklist

Plate Tree
Plate Layout

The Plate Tree zone shows how many plates are included in the worklist.

2. Click on the plus sign (+) next to the first plate to expand it and see which
assay is programmed on this plate.
3. Click on the assay name (as shown above). In the Plate Layout zone,
you can now review the arrangement of the test on the plate: number of
samples to be tested, wells used for controls, etc.
If you want to review the individual sample IDs to be tested on this plate,
click the plus sign (+) next to the assay folder.
4. Repeat these steps to review successively all plates and all assays
included in the worklist.
5. List and prepare the Bio-Rad kits that you will need to process the
assays included in this worklist.

6. As a general rule, it is recommended to accept the worklists suggested

by the system. Click OK to validate the worklist.

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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 16: 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 on the Batch Number drop-down list and 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 17: 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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If the batch number printed on the kit package is not listed in the
drop-down list, 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 the Batch
Number drop-down list 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 18: Worklist window

1. Click the plus sign (+) next to the top folder to expand it. You can then
click the various items successively (worklist parameters, schedule,
plate layouts…) to review the worklist. If something is incorrect and you
need to go back to the Set-up Panel dialog box, select Edit | Panel
Definition from the menu bar.
2. Click the Reagent requirements item to display the list of all required
reagents.

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Figure 19: 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 upper 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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EVOLIS Version 2.4 – User Manual

Complete the Loading Process

When you click the Start button, the Load dialog box opens showing you
where to load all required resources.

Figure 20: Load dialog box

Wash solutions and rinse fluid

(if any) Dilution plates, diluent, archive plates
Pipetting tips
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, moving the mouse pointer over any resource
displays the details (name, volume…) of this resource.

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2.4.1 Wash Solutions and Rinse Fluid

Figure 21: Load wash solutions

The second part of the reagent list you previously printed (see Figure 19)
indicates which quantity of each solution is required for the planned worklist.

1. Open the lower drawer of the EVOLIS instrument to access the wash
solution containers.
2. 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).
3. 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.

When the bottom drawer is open, strictly avoid leaning on it. The
drawer and/or the instrument may tip over!

Mechanical hazard - If additional wash solution is required during a

run, a message will be displayed and the system will unlock the lower
drawer to allow you to load the solution. The instrument is paused but
if the plate transport module, on the right hand side of the drawer (see
number on Figure 2), was in the process of moving a plate, it will
bring the plate to its scheduled destination before stopping.
Please be careful and wait until all movement has stopped before
opening the drawer.

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2.4.2 Dilution Plates and Diluent (if any)

Diluent Diluent

Green Green

Blue

Figure 22: Load dilution and archive plates (if any)

No dilution plate and no archive plate required

Dilution plate (green) and diluent required
Dilution plate (green), diluent and archive plate (blue) required

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.

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2.4.3 Pipetting Tips

Figure 23: Load tips

1. Open the tip racks and dilution plates loading drawer.

2. Load the pipetting tips as shown in the Load dialog box. 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).
3. When inserting the tip racks, make sure the slot in the tip rack is correctly
positioned.
After inserting the tip racks, push them down again to make sure they
are level.

4. When all tip racks are loaded, check visually once again that they are all
positioned as depicted in the Load dialog box before closing the loading
drawer.

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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2.4.4 Reagents

a) Before b) After

Figure 24: Load reagents

The first part of the reagent list you previously printed (see Figure 19) 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. Open the door of the samples and reagents unit. Insert the reagent racks
one by one on the EVOLIS instrument on the tracks marked by a red
LED.
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 24 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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2.4.5 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 25: Load plates

1. To enter a customized Plate ID, click in the Plate ID… entry field 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".
If you use barcoded test plates, see Section 3.2 (end of Section).
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. Insert the microplate in a microplate holder (metal frame) provided with
the instrument. Make sure to match the A1 corner of the microplate with
the A1 mark on the plate holder.
Push the microplate down firmly so that its surface is perfectly horizontal.
4. Open the door of the microplate loading compartment and load the
microplate (on its holder) into the plate transport unit.
5. Close the door of the microplate loading compartment and click OK. The
microplate moves in. The Load Plate dialog box closes 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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Plate IDs are limited to a total of 20 characters/digits. This means that

customized plate names cannot actually exceed 12 characters/digits
plus the automatic 8-digit date and rank tag ("YYMMDDXX"). A space
is equivalent to a character.
This limit (12 characters/digits) also applies if you use barcoded
microplates.

If you use non-barcoded microplates, the system cannot detect it in

case there is an error or a mix-up between plates during the loading
stage (e.g. if you load a plate from an HIV kit for an HCV test). It is
therefore essential to make sure to load the correct microplate for each
test.

See also Barcoded test plates, see Section 3.2.

Multi-assay per plate, see Section 3.10.

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Run

Once you click OK after loading the last microplate, the run starts
automatically.

Figure 26: 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.
In particular, make sure that the door of the samples and reagents
loading unit remains closed. If you need to reload samples or reagents
during a run, operate as described in Section 3.13 but close the door
again as soon as the resources are loaded. Leaving the door open
pauses the processing and may lead to processing errors (e. g.
incubation overrun) and invalid results.

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 26 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).

The EVOLIS software does not include any auto-logout option.

The Windows standby mode is also disabled on the EVOLIS computer to
avoid any disturbance to the scheduler while the EVOLIS system is running.

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EVOLIS Version 2.4 – User Manual

It is therefore recommended, to avoid any interference but also for

data protection purposes, that the EVOLIS system be located in a
secure area and not left unmonitored for extended periods of time.

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.
Reloading wash solution during a run, see Section 2.4.1.
Errors during the run, see Section 3.11.
Emergency stop, see Section 3.12.

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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 27: Result window

You can review the result report on the screen 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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2.6.1 Understanding / Validating Result Reports

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

Figure 28: 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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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 critical
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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Additional information on result calculation

The result calculation algorithms used by the EVOLIS system for each test
(validation criteria, quantitative results, qualitative results…) are programmed
in the corresponding assay file. If you need therefore more information on how
specific results were calculated you can open and review the corresponding
assay file as described in Section 3.1.
For Bio-Rad tests, these result calculation algorithms are programmed to
reflect strictly the result calculation method described in the corresponding kit
insert. In some rare cases, small adaptations are required to take into account
differences between the manual and the automated process. These
adaptations are then documented for end-users in the "EVOLIS APF Manual".
All assays are fully validated by Bio-Rad.

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, select the Utilities |
Export Results menu item to export the results to the LIS (or to another
folder or network location).
If you do not select the Utilities | Export Results menu item, when you
try to close the displayed result file, the system asks you again if you
want to export the results.

Figure 29: 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 3.18.

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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 30: Unload plates

1. Unload the microplates one by one, each time this message is displayed.
When removing the microplate from the plate transport, lift carefully to
avoid spilling.
After unloading the first microplate, close the door of the microplate
loading compartment, 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 3.21.
5. Check the liquid waste level in the liquid waste container. If full or nearly
full, decontaminate and empty as described in Section 3.21. If
necessary, refill the liquid-system container.

You can now either start a new run immediately or log off as described in the
following Section.

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2.7.2 Log Off

The EVOLIS software does not include any auto-logout option.

The Windows standby mode is also disabled on the EVOLIS computer to
avoid any interference with the scheduler while the EVOLIS system is running.

For data protection purposes it is therefore recommended that you

manually log off the software when the run has ended until you are
ready either to start a new run or to shut down the EVOLIS system as
described in the following Section.

Logging off the EVOLIS software

To log off the EVOLIS software:
1. Select File | Close to close all open windows.
2. Select the Utilities | Log-Off/Log-On… menu item (if you cannot see
the Log-Off/Log-On… menu item, make sure you have closed all open
windows as indicated in Step 1 above). This opens the Log-On dialog
box in which both fields are blank.

Figure 31: Log-Off/Log-On

3. Leave both fields blank and do not click OK.

This way, anyone who wants to use the EVOLIS system later will have
to log in with his/her own user account.

Logging off Windows

There are several ways to log off Windows when leaving the EVOLIS
computer unattended: standby mode, change user, lock the system…

It is the laboratory's IT Specialist responsibility to decide what rules

should be enforced in this situation and to train users accordingly.

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2.7.3 Shutdown / End of Day Maintenance

1. Make sure all processing has ended. Perform the end of run
maintenance described in Section 2.7.1.
2. Close the EVOLIS software. Select File | Exit from the menu bar or click
the X icon in the top right-hand corner of the EVOLIS software window.
3. Switch off the system (switch on back panel of the instrument).

Always exit the EVOLIS software and the Windows software before
switching off the system!

4. Open the instrument cover and wipe the tip adapter (pipettor head) using
a soft lint-free cloth moistened with 70% Ethanol.
5. Inspect the instrument (inner and outer surfaces) for stains and spills. If
necessary, clean as described in Section 3.21.

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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 Network Connection and Cybersecurity
3.17 Import
3.18 Export
3.19 User Management
3.20 Demo Mode and Connections
3.21 General Maintenance Tasks and Maintenance Schedule
3.22 Software Maintenance
3.23 Disposal of an EVOLIS System

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Assays

The EVOLIS 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\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 APF Manual" which includes a correspondence table between
Bio-Rad kits and EVOLIS 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.

2. In the Open dialog box, select the assay file you want to review and click
Open.
3. 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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Figure 32: 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.

The APF files must be installed on your EVOLIS system by your

Bio-Rad Service Engineer.
An installation/upgrade procedure is included in the "EVOLIS APF
Manual". For the correct installation of the APFs, it is essential to
always follow that procedure as it also updates other required software
items (e. g. the reagent database or the plate database). This must be
done even if you intend to use your EVOLIS system only with non-
Bio-Rad reagents.
Never try to install a new APF version by simply copying and pasting
*.asy files to the "C:\BioRad\Resources\Apf" folder!

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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.
Sample IDs, whether barcoded or manually entered, are limited to 20
alphanumeric characters.

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 blank entry field.
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 in the blank entry field, enter the sample ID via
the 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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Figure 33: 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.

Barcoded test plates

The microplates included in Bio-Rad kits are generally not barcoded. The
plate-loading compartment, however, is fitted with a barcode scanner so that
you can use barcoded microplates provided you affix appropriate barcode
labels prior to loading the microplates. Your Bio-Rad Service Engineer can
help you define appropriate microplate barcode labels.

This procedure applies to test plates only. No positive identification is

available for dilution or archive plates.

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1
A

a) b)

Figure 34: Microplate barcodes

1. When attaching the barcode label on a microplate, make sure:

a) To place it on the vertical left-hand side of the microplate (the side
with the "A-H" letters).
b) That the barcode label does not protrude over the side of the
microplate (improperly placed labels can get jammed in incubators,
reader and washer causing transport errors).
2. Place the microplate in a microplate holder (metal frame) and load it as
described in Section 2.4.5, except that instead of entering a plate ID
manually and clicking OK, just click Scan and the system will
automatically identify the microplate through its barcode.
If the Verify during processing check box is selected the system will
scan the plate again, during the run, each time the plate is moved from
one module to another (e.g. from an incubator to the washer).

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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Samples

Sample type and treatment

For all Bio-Rad tests, the type of sample to be used (serum, plasma, whole
blood…) as well as any sample pretreatment that may be required are
specified in the kit insert for each test.
In case a predilution of the sample is required, this will be performed by the
EVOLIS system. To confirm this, you can open and review the corresponding
assay file as described in Section 3.1 and/or read the "EVOLIS APF Manual".
If clots are suspected, proper preparation of the samples (e.g. centrifugation)
is recommended prior loading. If a clot is detected in a sample during a run,
the sample will be flagged (see Section 3.14) and its result will not be
calculated.

Sample volume
A minimum volume of sample of 200 µl per tube is recommended. If you need
to test lower volumes, smaller sample tubes may be used but this will require
the intervention of Bio-Rad Technical Support as explained below.

Non standard sample tubes

The standard T (20 tubes) or B (22 tubes) sample racks are designed to
accommodate tubes with a diameter between 10 and 16 mm and a height not
exceeding 10 cm.

T B

Figure 35: EVOLIS sample racks

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 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."

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Remove one of the sample tubes or use another barcode on one of the tubes.

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Reagents and Controls

Reagent, controls and calibrators

For Bio-Rad tests, all reagents, controls and calibrators are included in the
kits. All information on their composition, volume, storage, handling and
preparation is provided in the kit insert.
In case a specific preparation, directly linked to their use on the EVOLIS
system is required (e.g. transfer into a tube or another type of container), all
instructions are given in the "EVOLIS APF Manual".

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 system.

-3 -2 -1 -0

Figure 36: EVOLIS reagent racks

Rack code Description & capacity

Large reagent rack
7 positions for bottles Ø < 38 mm (e.g. 30 ml / 60 ml bottles)
3 positions for bottles Ø < 28 mm (e.g. 10 ml / 10 ml bottles)
11 positions for bottles Ø < 16 mm (e.g. 5 ml vials)
-0 Notes: 1) The three 28 mm-positions as well as six of the 16-mm positions
located on the left-hand side of the rack cannot be read by the integrated
barcode scanner! Whenever possible, use the other reagent racks rather
than these positions.
2) For diluent bottles with a diameter greater than 39 mm, see Section 3.6.
Medium reagent rack
12 positions for bottles Ø < 28 mm (e.g. 10 ml / 10 ml bottles)
-1
Note: With size-adaptors, this rack can be also be used to load smaller vials
(see below).
Small reagent/control rack
20 positions for bottles Ø < 16 mm (e.g. 5 ml vials)
-2 This rack is specially designed (with height-adaptors on the bottom of each
loading position) to make it possible to load directly the small control and
calibrator vials included in most Bio-Rad kits.

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Rack code Description & capacity

Small reagent/control rack
20 positions for tubes Ø < 16 mm
-3
This rack is similar to rack -2 but without height-adaptors. Use this rack when
controls or calibrators have to be transferred into sample tubes.
Small 22-position reagent/control rack (not shown)
-4
This rack is identical to rack -2 but includes 22 positions instead of 20.

Adaptors for small diameter bottles

Small reagent bottles that are too wide to be loaded in a -2 control rack can
be loaded in the medium-size -1 reagent rack thanks to specially designed
size-adaptors.

Figure 37: Rack adaptors for small reagent bottles

The adaptors help keep the bottles correctly centered within each rack
position.

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 or a -4
reagent rack nor on ordinary T or B sample racks.
 That small diameter bottles are not loaded on the -1 reagent rack
without a size-adaptor.
Incorrectly loaded reagents can cause pipetting errors or even induce
damage to the pipettor itself.

Insufficient reagents/ controls/ wash buffers

Most Bio-Rad kits are sold in "1-microplate" format. This means that the kit
package includes one microplate and the appropriate volume of reagents,
controls and wash buffers required for the processing of the 96 wells of this
microplate. A few Bio-Rad kits are also available in "5-microplates" format, in
which case, similarly, they include the necessary reagents/controls/wash
buffers for the processing of five microplates.

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Therefore, when using Bio-Rad kits on the EVOLIS system, you should not
encounter any problems related to an insufficient volume of reagent, control
or wash buffer.
If, however, for any reason the volume of any of these liquids becomes
insufficient during a run, the consequences will be as shown in the table below.

Insufficient volume of… Consequence

Control The EVOLIS system will pause at the end of
the pipetting step and display a message
prompting the user to dispense the missing
control manually. The run resumes
automatically when the user clicks OK to close
the message after the manual dispense.
If the user does not dispense the required
control manually, the worklist will be paused
indefinitely with the risk of all plates being
invalidated.
Kit reagent Under default settings, the EVOLIS system
will complete the run as planned but all
samples processed after a kit reagent was
detected as insufficient will be flagged and
their result will not be calculated (see Section
3.14).
To avoid this, please ask Bio-Rad Technical
Support to enable the pre-run reagent volume
check option (see Section 3.11). When this
option is enabled, the EVOLIS system checks,
before the start of the run that the reagents
needed for the programmed worklist have
been loaded in sufficient quantity. If not, a
message is displayed indicating which reagent
is insufficient giving you the choice of adding a
sufficient quantity of reagent, starting the
worklist as is or aborting the worklist.
Wash buffer If a required wash buffer runs out during the
processing of a worklist, the EVOLIS system
will pause the run and prompt you to add some
wash buffer (see end of Section 2.4.1).

If you are prompted to provide additional reagent/control/wash buffer,

either during a run or during a pre-run check, always observe Good
Laboratory Practices!
Particularly, do not top up bottles with reagent from a different kit lot,
and make sure the additional reagent has been stored and prepared in
accordance with the instructions provided in the kit insert.

Special case: small worklists - Please note also that even though each kit
package includes adequate quantities of reagent/control/wash buffer to

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process one microplate, if you multiply "small" worklists, i.e. worklists with very
few samples for each test instead full-plates or even half-plates, some
reagents may run out before all the microplate wells have been used. This is
because the volume of liquid required for automated pipetting steps or wash
steps can be slightly greater than when these steps are performed manually
due to pump priming, greater dead volume or oversoak settings. Bio-Rad
Technical Support can provide assistance in optimizing your worklists to try
and avoid this.

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 19) 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.

Reagent Lot Tracking

The EVOLIS 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.

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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 38: Declare reagent lots

2. With the handheld scanner, scan the main kit barcode on your kit box.

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Assay Name

Batch Number

Expiry Date

Main Kit Barcode

Product Code

Figure 39: Kit information on kit package

3. All general kit information (except the kit expiry date) is automatically
entered.

If the general kit information is not automatically entered when you

scan the main barcode on your kit box, this means that the EVOLIS
Software cannot find some of the required kit database files (these may
have been incorrectly installed or unintentionally deleted). Please call
Bio-Rad Technical Support.

4. Enter the Expiry Date manually via the keyboard, making sure to
conform to this format: DDMMYY
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, as well as the reagents to be used with this assay.

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Figure 40: Scan kit bottles

There are two ways of entering the barcodes of individual kit components. You
can either:
 Use the handheld scanner to scan the barcodes of individual kit
components printed on the kit box.
or
 Place the kit bottles on the reagent racks and load the racks on the
EVOLIS system so that the barcode labels are scanned by the system's
integrated scanner.

Method 1 - Scan the barcodes on the kit box

1. In the Scan Kit Bottles dialog box, click the Scan Box Label... button.
This opens the Scan Barcode dialog box.

Figure 41: Scan barcodes on kit box label

2. Using your handheld scanner, scan all barcodes on the kit box
corresponding to your kit bottles. You do not need to click OK between
two scans.

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Individual
component
barcodes

Figure 42: Individual component barcodes on kit package

3. When all barcodes are scanned, click OK. This closes the Scan
Barcode dialog box. In the Scan kit bottles dialog box, you can see the
scanned barcodes.

Figure 43: Scanned barcodes

Some generic reagents (e.g. stop solution) are scanned but their
complete name is not entered. This is normal. They do not need to be
tracked.

4. Click Close to close the Scan kit bottles dialog box. In the Kit
Information dialog box, the complete kit lot data is now entered.
5. Click OK to save and close the Kit Information dialog box.

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Method 2 - Scan the reagent bottles with the EVOLIS integrated scanner
1. Open the kit package and load all reagents and controls on the reagent
racks.

2. Load the racks one by one on the EVOLIS instrument on the tracks
marked by a red LED. The individual reagent barcodes are read and the
corresponding data is displayed in the Scan Kit Bottles dialog box.
3. Click Close to close the Scan Kit Bottles dialog box. In the Kit
Information dialog box, the complete kit lot data is now entered.
4. 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.
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.

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Independent controls
Independent 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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Non Bio-Rad Kits

This manual describes only how to use the EVOLIS 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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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 plates and diluents

Green
1. If the tests you intend to process require pre-dilution plates, this will be
shown in the Load dialog box (see Figure 22). Dilution plates are
displayed in green (sample archiving plates are displayed in blue).

2. Open the tip racks and dilution plates loading drawer. The dilution area
allows you to load up to three plates.
3. Load the required dilution plate(s) as shown in the Load dialog box. Push
each plate down 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
Diluent
corner, and drag it to the correct position at the back of the dilution area.
No barcode identification is available when diluents are loaded in this
position.
Dilution
Plate

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The system cannot detect whether you have effectively loaded the
required dilution plate(s). If a dilution plate is missing, potentially
contaminated material (sample, controls) may be spilled!
It is therefore essential not to forget to load the required dilution
plate(s).

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Pipetting Tips

Use only the pipetting tips specially supplied by Bio-Rad for the
EVOLIS 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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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\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. "20210228.log" (YYYYMMDD)

To view the log file for the current day (during of after a run):
1. In the worklist tree (left-hand side of the Worklist window), select the
Active Event log item.

To view the log file for runs performed on previous days:

1. In the main toolbar, click the Open button.

2. In the Open dialog box, navigate to the C:\BioRad\Resources\Event_log

directory and select the log file for the day of the run you want to
investigate.
3. Once the log file is open, a Filter… option (in the View menu) allows you
to 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\Resources\Event_log directory) and mail it to your Bio-Rad
Service Engineer.

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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.

Figure 44: Schedule view

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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Multi-Assay per Plate

The EVOLIS system allows you, under certain conditions, to combine several
assays on the same test plate, e.g. HBe Ab (antibody) and HBe Ag (antigen).

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 45: 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.

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.

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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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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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Avoid/detect pipetting errors

The EVOLIS 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 (see Section 3.4, paragraph Insufficient reagents/
controls/ wash buffers).
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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Pausing a Run / Emergency Stop

Click the Stop button in the upper toolbar to pause the run. The following
dialog box is displayed.

Figure 46: Pause the run

You can then choose to restart the processing (Resume), to select one or
more plates and click Abort Plate(s) or abort the complete worklist. If you click
Abort Plate(s) 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 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 2.7.3.

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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 system under certain conditions.

1. Prepare the sample racks with the new samples.

2. 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.
3. Open the door of the samples and reagents unit and check the LEDs at
the back of the sample loading unit. You can remove all the racks for
which the LEDs are flashing.

4. Insert the first rack with new samples on the first track marked by a red
LED.
5. Review and validate the Patient Editor for this rack and repeat the
process if you have other racks to load. After all new racks have been
loaded, close the door of the samples and reagents unit.
6. In the menu bar, select Edit | Panel Definition… . 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 upper
toolbar and reload all required resources (reagents, dilution plates, tip
racks, wash buffer, test plates) as in a normal worklist.
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.

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11. Wait until the specified time has elapsed (or until the time bar enters a
brown section in the Schedule view), then select Edit | Panel
Definition… in the menu bar 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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EVOLIS Version 2.4 – User Manual

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.

If a result is flagged you should always review the logs of the run to
attempt to understand why (see Section 3.8).

The software uses 13 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).
CovOp Cover open. This flag is used if the instrument cover has been opened during
a run. No results are calculated for samples that had not yet been pipetted
at that stage.
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.

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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).
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. Results for flagged samples are not
P_static_high, calculated.
P_static_low, P_max_high Aspiration pressure too high Clot
P_mean_low
P_min_low Aspiration pressure too low Foam or air

P_stop_high Pressure at pump stop too Clot

high

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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Recalculate Results

When a Result report is displayed, the Edit | Outliers… menu item 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 Edit | Outliers… menu item 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 47: 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, select the View | Recalculate menu item.
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 OD values
for each assay by selecting the assay you want in the Assay Protocol drop-
down list. The Reading drop-down list shows the wavelength(s) used for the
reading.

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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), CovOp (Cover open), 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) or pressure
monitoring errors 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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Network Connection and Cybersecurity

Network connection set-up

The EVOLIS system can be operated without any network connection. It is
the lab manager's responsibility to decide, in collaboration with the
laboratory's IT Specialist, whether the EVOLIS system should be connected
the laboratory's network and information system (LIS).

A Connectivity Manual (in English) is available on request.

If the EVOLIS system is to be connected to the laboratory's network, it is the

laboratory's IT Specialist's responsibility to implement the physical connection
(hardware, cables…) and enable the Windows-level connection of the
EVOLIS computer to the local network.

Bio-Rad Technical Support will configure the communication links in the

EVOLIS software according to the specifications provided by the lab manager
and the laboratory's IT Specialist (assistance from the LIS vendor may also
be required):
 Communication protocol: ASCII or ASTM.
 Bidirectional communication or result export only.
 Automatic or manual import of test orders.
 Assay names used/expected by the LIS.
 Values expected in the exported results: OD, concentration, ratio…
 And any other specific requirement.

Once the settings are defined, Bio-Rad Technical Support will test the data
transfers between the EVOLIS system and the LIS, check that they are
correctly executed and contain the required data.

Firewall / Anti-virus software

No firewall is enabled on the EVOLIS computer.
No anti-virus software is pre-installed on the EVOLIS computer.
Installation of any firewall or anti-virus software on the EVOLIS computer
needs to be validated by the customer to make sure there are no issues with
processing speed or performance issues with any of the installed programs.
The customer is also responsible for updating any firewall or anti-virus that
they have installed as well as reinstalling them if the computer needs to be
replaced by Bio-Rad for any reason.
Installation of a firewall or an anti-virus software on the EVOLIS computer can
only be performed by a user with a "local_admin" Windows account (i.e.
by the laboratory's IT Specialist - see Section 3.19.1).
Any device connected to the EVOLIS computer, including USB storage
devices, must be scanned for viruses prior to connection.

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AppLocker
AppLocker is a Windows Security Technology that controls which applications
and files a user can run. This feature is enabled on all EVOLIS computers with
a Windows 10 operating system. This also includes EVOLIS computers
upgraded to Windows 10 by Bio-Rad Technical Support.
On EVOLIS computers, AppLocker prevents, for example, Windows
"Standard users" (i.e. all end-users of the EVOLIS system logging in with the
"User" Windows account, see Section 3.19.1) from running *.exe files or
scripts from a USB drive and from copying such files from a USB drive to
specific directories of the EVOLIS computer's hard drive.
For more information on the AppLocker rules implemented on EVOLIS
Windows 10 computers, please call Bio-Rad Technical Support.

BRiCare
BRiCare is a Bio-Rad software external to the EVOLIS software that can be
used by Bio-Rad Technical Support to provide remote support through a
secure connection. It can also transmit non-sensitive data to Bio-Rad for
troubleshooting purposes.
The BRiCare applet is not enabled by default on EVOLIS computers. It is
offered to customers as an option. A separate BRiCare documentation is
available on request.

Sensitive patient data

The EVOLIS software's patient and result databases can store the following
patient personal data:
 Patient name.
 Patient birth date.
 Patient sex.

These data, however, are not required to process the samples. Only the
"Patient ID" (alphanumeric sample ID) is required for valid test orders and
results.

For cybersecurity and confidentiality purposes lab policy must ensure:

 That lab technicians and other operators of the EVOLIS system be
trained to never enter the above-mentioned sensitive patient data
manually in the EVOLIS software.
 For EVOLIS systems connected to an LIS, that LIS rules are defined
in such a way that these sensitive patient data are not sent to the
EVOLIS software.

Under default settings, all assay protocol files (APFs) validated by Bio-Rad
for EVOLIS (see Section 3.1) are programmed so that no sensitive patient
data will be included in the printed result reports.

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For EVOLIS systems connected to an LIS, Bio-Rad Technical Support, when

configuring and testing the import and export communication links in the
EVOLIS software (see the Network connection set-up paragraph above), will
also make sure that no sensitive patient data are included in the transferred
data.

It is essential that these APF settings and import/export settings in the

EVOLIS software are not edited to include sensitive patient data.

File protection
Most files types used or generated by the EVOLIS software are in proprietary
format. This means that they can only be opened and viewed, used or edited
with the EVOLIS software. This applies for example to assay files (*.apf),
panel files (*.pan), result files (*.res), log files (*.log).
Assay files can also be password-protected. All official assay files provided by
Bio-Rad are password-protected.

Lab policy must ensure that users do not tamper with EVOLIS files
(stored in the "C:\BioRad" folder and subfolders - see Section 1.5.2)
nor attempt to open or process them using third-party software.

Cybersecurity breach
In the event of an actual or suspected cybersecurity breach, please call Bio-
Rad Technical Support as soon as possible.
For more information on data recovery possibilities, see Section 3.22.

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Import

When installing the system, Bio-Rad Technical Support will configure the
communication links and import process (file format, file polling interval…) so
that the EVOLIS 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 48: 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 blank drop-down lists located above the table and
select an assay for each column.
2. Add checkmarks manually by clicking in the appropriate table cells.
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. 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 red 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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Export

When installing the system, Bio-Rad Technical Support will configure the
communication links and export process (file format, exported data…) so that
the EVOLIS 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 V20]

[Results]
Patient ID|Assay|Well|Flag|Value|S/CO|Result
""|"HIV Ultra Ag-Ab 1P BR V20"|"A1"|""|"2,0650"|"6,1950"|"PC Ag1"
""|"HIV Ultra Ag-Ab 1P BR V20"|"B1"|""|"2,1860"|"6,5580"|"PC Ab1"
""|"HIV Ultra Ag-Ab 1P BR V20"|"C1"|""|"0,1380"|"0,4140"|"NC1"
""|"HIV Ultra Ag-Ab 1P BR V20"|"D1"|""|"0,1260"|"0,3780"|"NC2"
""|"HIV Ultra Ag-Ab 1P BR V20"|"E1"|""|"0,1360"|"0,4080"|"NC3"
"000001"|"HIV Ultra Ag-Ab 1P BR V20"|"F1"|"ManID"|"0,1160"|"0,3480"|"NEG"
"000002"|"HIV Ultra Ag-Ab 1P BR V20"|"G1"|"ManID"|"0,1080"|"0,3240"|"NEG"
"000003"|"HIV Ultra Ag-Ab 1P BR V20"|"H1"|"ManID"|"0,1770"|"0,5310"|"NEG"
"000004"|"HIV Ultra Ag-Ab 1P BR V20"|"A2"|"ManID"|"0,9000"|"2,7000"|"REACTIVE"
"000005"|"HIV Ultra Ag-Ab 1P BR V20"|"B2"|"ManID"|"0,8150"|"2,4450"|"REACTIVE"
"000006"|"HIV Ultra Ag-Ab 1P BR V20"|"C2"|"ManID"|"0,6620"|"1,9860"|"REACTIVE"
"000007"|"HIV Ultra Ag-Ab 1P BR V20"|"D2"|"ManID"|"0,4760"|"1,4280"|"REACTIVE"
"000008"|"HIV Ultra Ag-Ab 1P BR V20"|"E2"|"ManID"|"0,3710"|"1,1130"|"REACTIVE"
"000009"|"HIV Ultra Ag-Ab 1P BR V20"|"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 Specialist 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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User Management

Windows / EVOLIS
On the EVOLIS system, user groups and access rights are managed at two
separate levels:
 At the Windows level.
 At the EVOLIS software level.

3.19.1 Windows User Groups and Access Rights

As described in Section 1.2, there are three pre-defined Windows user

categories and four pre-defined user accounts available on the computer
provided by Bio-Rad with the EVOLIS system.
Out of these pre-defined user accounts, two are more specifically important
for users of the EVOLIS system:
 The "User" account.
 The "local_admin" account.

Windows "User" account

The "User" account is a non-administrative Windows account. It strictly limits
the use of the EVOLIS computer to its use with the EVOLIS software and
system. All end-users are required to use this Windows account when logging
into Windows in order to use the EVOLIS system. The password for this
account is defined by the laboratory manager when logging in for the first time
(see Section 1.5.1).

It is the responsibility of each laboratory to:

 Set the password for the common Windows "User" account.
 Keep it confidential and limit access to this password to authorized
laboratory personnel.
 Store, recollect and periodically reset this password. Bio-Rad
Technical Support will not know this password.

Windows "local_admin" account

The "local_admin" account is a Windows administrator account. It is
needed for specific uses such as connecting the EVOLIS computer to a
laboratory network or installing authorized software (e.g. antivirus software,
see Section 3.16).

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The predefined "local_admin" account is intended only for the

laboratory's IT Specialist (on the role of the laboratory's IT Specialist,
see below)!
It may be used by this person to adapt the computer's settings to the
laboratory's IT environment and policies.
It must not be shared with routine users of the EVOLIS system.

The password for the Windows "local_admin" administrator account is set

and managed by Bio-Rad. It cannot be changed. It will be provided to the
laboratory's IT Specialist by Bio-Rad Technical Support.

It is the responsibility of the laboratory's IT Specialist to maintain the

confidentiality of the password for the "local_admin" Windows
administrator account.

Role of the laboratory's IT Specialist

Whereas the use of the EVOLIS system to run sample analyses is intended
for the categories of scientific personnel specified in Section 3.19.2 below,
tasks related to data protection and the administration of user accounts must
be performed by or under the supervision of the laboratory's IT Specialist.
This person shall assume the role of Windows system administrator described
above.
This person is responsible for any changes made to the EVOLIS computer's
operating system and files (see also Section 1.5.2), and for ensuring that the
laboratory's data protection policy is adequately implemented, particularly if
the EVOLIS computer is to connected to an LIS or any other network (see
Section 3.16).

In laboratories that do not have a dedicated IT Specialist, this role can be

assumed by the lab manager. In this case, Bio-Rad recommends that the lab
manager use the "local_admin" account only for Windows administrative
purposes and logs in again with the Windows "User" account when intending
to run the EVOLIS system.

3.19.2 EVOLIS User Groups and User Access Rights

Under default settings, two pre-defined user groups are available in the
EVOLIS software:
 Supervisors,
 Users.

The user profiles for these two groups are described in Section 1.2.

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Initial access rights of these two user groups are as follows.

User access rights Supervisors Users

Create assays Yes No
Edit assays Yes No
Change preferences Yes No
Manually remove outliers Yes No
Edit patient details Yes No
Change system setup Yes No
Edit running worklists Yes No
Administer users Yes No
Edit Worklist Options Yes No
Start Worklists Yes No
Post Results to LIMS Yes No
Restore Backups Yes No

When installing the system, Bio-Rad Technical Support will pre-set the
access rights of the "Users" group in accordance with the requests of the lab
manager. Other, more specific user groups can also be created.

When installing the system, Bio-Rad Technical Support will also create
individual user accounts for all operators of the EVOLIS system as requested
to reflect the laboratory organization.

In the EVOLIS software, an individual user account must be created for

each person who will be authorized to use the EVOLIS system.

There must be at least one "Supervisor"-level user (full access group

user) on each EVOLIS system. Typically the EVOLIS "Supervisor"-level
account is reserved for the lab manager or senior laboratory personnel.

Creating / editing / deleting a user

The laboratory's "Supervisor"-level user must be able to create, edit or delete
other EVOLIS software accounts to reflect the changes in the laboratory
personnel.

Lab policy must ensure that each operator always logs in under his/her
own user name and password.

The user accounts of operators who are no longer part of the

laboratory personnel must be deleted.

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To create a new user:

1. Select the Utilities | Options menu item to open the Options dialog box
and select the Users tab.

Figure 49: Create a new user

2. In the User Name field of the New User zone, enter the name of the
person for whom you are creating an EVOLIS user account and click
Add User.
When you click Add User, the name you just entered is also displayed
below in the User Name list of the Existing Users zone.
3. In the Available Groups zone, select a user group for this new user and
click the arrow button to transfer it to the Member Of zone.
It is possible to select more than one user group for the same user. In
that case, this user will cumulate the access rights of all selected groups.
4. Click OK.

The new user will then need to set his/her password as described in Section
1.5.1 paragraph 2) EVOLIS software first login.

Editing a user generally involves assigning a user from one user group to
another, for example upgrading a senior lab technician from the "Users" group
to the "Supervisors" group.

To do this:
1. Open the Users tab of the Options dialog box as described above.
2. In the User Name list of the Existing Users zone, select the name of
the user you want to upgrade. The Member Of zone is updated to show
the user group this user currently belongs to.
3. Use the arrow buttons to assign this user to a different user group.
4. Click OK.

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To delete a user:
1. Open the Users tab of the Options dialog box as described above.
2. In the User Name list of the Existing Users zone, select the name of
the user you want to delete and click the Delete user button.
4. Click OK.

3.19.3 Password Management

It is the responsibility of the laboratory's IT Specialist to define and

enforce a robust password policy for all EVOLIS system users.

1) Windows passwords
For more information on passwords for the "User" and "local_admin"
Windows accounts see also Section 3.19.1.
The laboratory's IT Specialist, logging in as "local_admin", can clear the
password of the Windows "User" account according to general Windows 10
procedure. A new password will then need to be set as described in Section
1.5.1 for the first login.

Windows passwords must include at least 8 characters.

2) EVOLIS software passwords

The EVOLIS software does not include any rules on password format. Even
blank passwords are technically possible.

It is therefore essential that laboratory rules be implemented to avoid

blank passwords, common passwords, "obvious" passwords, etc.
It is the laboratory's IT Specialist responsibility to define what rules
should be enforced and train EVOLIS users accordingly.

How to set or reset EVOLIS passwords

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.

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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.
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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Demo Mode

Demo mode
If you want to use the EVOLIS 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 checkbox before clicking OK.

Figure 50: Demo mode

Select Demo mode also if you install and use the EVOLIS software on a
separate computer.

To change back from Demo Mode to the normal operating mode:

1. Select File | Exit to quit the EVOLIS software.
2. Switch on the instrument.
3. Restart the software and do not check the Demo Mode item in the Log-
On dialog box.

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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 container refill

Deionized water is used as system-liquid, so no specific system-liquid
preparation is required.

Maximum fill-level = 10 liters.

1. Unscrew the cap of the system-liquid container. Place the cap, tubings
and sensor on absorbent paper.
2. Refill the container with deionized water (up to the 10 liter mark).
3. Screw the cap back on, making sure the level sensor and tubing are
correctly set.
4. If you refill the system-liquid container while the EVOLIS system was
already switched on (e.g. during the day, in-between two runs) it is
recommended that you run an automated "Prime pipettor" maintenance
after reconnecting the container.
To do this, click the System maintenance toolbar button. This opens
the System Maintenance dialog box.

Figure 51: Automated "Prime pipettor" maintenance

5. Select "Prime pipettor" and click Execute. A confirmation message is

displayed.

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6. Click Yes in the confirmation message to start the "Prime pipettor"

automated maintenance.
7. Wait until the routine is completed (progress bar disappears) and click
Close to close the System Maintenance dialog box.

If you refill the system-liquid container before starting the system, the
pipettor will be primed automatically when the EVOLIS system is
initialized (selftest procedure, see Section 2.1.2), so you do not need to
execute the "Prime pipettor" automated maintenance.
If you need to refill the system-liquid container during a run (e.g.
because a "system-liquid LOW" warning is displayed, see the
Troubleshooting table in Section 4), the process is managed
automatically by the software and you cannot execute the "Prime
pipettor" automated maintenance.

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
Microcide SQ® (diluted in deionized water at 1.6% - 16 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

Outer surfaces
Cover and handle Clean with any bactericide, virucide and
Outer panels, including washer window fungicide hospital-grade disinfectant. To
prepare and apply the disinfectant
(dilution, spray, wait, wipe...) refer to the
instructions prescribed by the product
manufacturer.
Inner surfaces
Dilution and tip rack area Same as above.
Sample and reagent unit
Test plate pipetting area
Pipettor guide rail
Bottom drawer
Plate transport unit and compartment Same as above.
Room-temperature incubators Clean once a month with the same
disinfectant as above. Spray the
disinfectant on a lint-free paper wipe and
wipe the inside of each incubator.
Heating incubators Do not clean!
Under wash solution containers Remove the containers and wipe the
bottom of the unit with a wet cloth (water
only, no disinfectant). Allow to dry or wipe
with absorbent paper.
Computer
Computer and monitor Use any standard (ammonia-free)
product recommended for the cleaning of
computers, including 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 use bleach or disinfectant which may damage metal parts. Do

not use disinfectants containing alcohol or acetone for Plexiglas
surfaces (cover).
Disinfectants must not come into contact with bearings and guides, as
otherwise the lubricant may dissolve.

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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 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.

The needles of the washer manifold are sharp and may be

contaminated! Always wear universal protective gear (gloves and lab
coat) when handling the washer.
If you ever need to lift the metal plate holding the manifold, take special
care so as to prevent the plate from falling back and the manifold
needles from causing potential injuries to hands (or damage to the
washer Z-motor).

Do not use the system until it has been checked by your Bio-Rad
Service Engineer.

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 (Microcide SQ® diluted in
deionized water at 1.6% - 16 ml per liter).

Note: In case Microcide SQ® is not available in your country, please

call Bio-Rad Technical Support for advice on an alternative product
that can be used for this purpose.

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 dialog box, click Add assay… and select the
appropriate assay:

for weekly maintenance WasherClean BR.asy

for monthly maintenance WasherManifoldDisinfect BR.asy

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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.

Note: During the monthly washer decontamination procedure,

messages will be displayed successively on the screen requiring you
to first unscrew the cap of "bottle 1" (first small washer flask), then
rescrew the cap after 15 minutes. It is therefore important that an
operator remains close to the instrument until the procedure is
completed.

Backup system files

Creating a backup of all system files is part of the monthly maintenance
routine. See Section 3.22 for more information.

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

 on Plate 1
CTRL CV Pipettor High Vol BR.asy
CTRL Washer Aspirate BR.asy  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 dialog box, click Add assay… and select the CTRL
CV Pipettor Low Vol BR.asy file.

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4. Do not add any samples. Click Add assay… again and, this time, select
the CTRL CV Pipettor High Vol BR.asy file.
5. Do not add any samples.
6. Click Add Plate… again to create the second plate.
7. Click Add assay… and select the CTRL Washer Aspirate 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 2.7.3.

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 2.7.3.

system.

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

Decontaminate the sample and reagent racks, the Prepare a decontamination solution consisting of 1.6 % (16 ml per
microplate holders (metal frames) and the tip ejection liter) Microcide SQ® and deionized water in a container/sink large
slide. enough so that you can immerse the racks, the plate holders 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 2.7.3.

system.

Decontaminate the system-liquid container Empty the container, then fill it with a decontamination solution
consisting of 1.6% (160 ml for 10 liters of deionized water)
Microcide SQ®.
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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Software Maintenance

Backup and restore

Creating a backup of all system files is recommended by Bio-Rad as part of
the monthly maintenance routine. The lab manager (in coordination with the
laboratory's IT Specialist) may decide on a more frequent schedule.

To perform the backup:

1. Click the Backup button in the upper toolbar. The System Backup
dialog box is displayed.

Figure 52: Backup system files

2. Click Backup System Files.

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\Backup directory. The path of the backup directory
can be edited as described in Section 1.5.2.
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).
For crash recovery purposes (see below) it is recommended to save a copy
of these backups either in a secure network location or on external media.

Create a complete system backup at least every month.

It is the responsibility of the laboratory's IT Specialist to define and
enforce an appropriate data archiving policy.

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Whereas backing up system files is recommended on a regular basis,

restoring system files should remain an exceptional procedure. If in
doubt, please call Bio-Rad Technical Support before restoring system
files!
It is also possible to restrict the right of restoring system files to
specific categories of EVOLIS users, e. g. "Supervisor"-level users (see
Section 3.19.2).

To restore backed up system files:

1. Click the Backup button in the upper toolbar. The System Backup
dialog box is displayed.

2. Click Restore System Files. This opens the folder where the backup
directories are stored, C:\BioRad\Backup (default) or another location if
you had changed the default target folder for backup directories. If you
want to restore backup files from external media you will need the
assistance of the laboratory's IT Specialist to copy the directories on the
EVOLIS computer first.
3. Find the "SYSyyyymmddnn" directory that you want to restore (generally
the directory with the most recent date) and double-click to open it.
4. Double-click on any file in that directory. This will restore all the files
included in the "SYSyyyymmddnn" directory (the directory itself is not
deleted).
5. At the end of the process, the following message is displayed:
"System files have been restored from
'C:\BioRad\Backup\SYSyyyymmddnn'".
Click OK to close the message.

Computer crash recovery

In the case of a computer crash or of a cybersecurity breach, Bio-Rad
Technical Support is able to replace the computer and/or re-image it to its
initial EVOLIS computer configuration.
The most recent backup directory can then be restored. Performing the
backups described above regularly is therefore essential to ensure that as
little data as possible is lost.

Software and APF upgrades

All upgrades of the EVOLIS software, including APF upgrades, must be
performed by Bio-Rad Technical Support. See also the "APF upgrades"
paragraph in Section 3.1.

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Microsoft Security Updates

Self-installing Windows Security Updates released by Microsoft are disabled
by default on the EVOLIS computer. Bio-Rad first analyzes Microsoft Security
Updates for relevancy and compatibility and then releases validated security
packages on a regular basis.

These validated security packages must be installed on all EVOLIS

computers.

Installation can be performed by Bio-Rad Technical Support if this is specified

in the laboratory's service contract.
If not, Bio-Rad will train the laboratory's IT Specialist on how to download and
install the security packages.

In case Microsoft issues an emergency update in response to a specific threat,

Bio-Rad will notify the laboratory of the availability of an emergency security
package and provide specific installation instructions if applicable.

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Disposal of an EVOLIS System

Both the EVOLIS instrument and the EVOLIS computer contain electrical
and electronic materials.
In countries of the European Union, this means that they are subject to the
WEEE European Union Directive (Directive 2012/19/EU of the European
Parliament and of the Council of 4 July 2012 on waste electrical and
electronic equipment) as attested by the crossed-out wheeled bin labels on
their back panels.
They must not be disposed of as unsorted municipal waste and must be
collected separately and recycled/dismantled/eliminated in compliance with
local regulations implementing the Directive in each country.

Contact your local Bio-Rad representative for assistance and country-specific

instructions.

Before disposal
Before disposal a complete decontamination of the EVOLIS system (inner and
outer surfaces, washer, waste container, racks…) must be performed, as
described in Section 3.21.
All other used accessories and consumables must be removed from the
system and discarded as contaminated waste. In case of residual kit reagents
(including wash solutions), please refer to the disposal instructions specified
in the corresponding kit inserts.
A backup of all relevant data from the EVOLIS computer to an external media
or a secure network location must be performed. After this backup has been
performed, all sensitive data, including the EVOLIS software, must be deleted
or otherwise permanently erased from the computer (e.g. by reformatting the
disk).

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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 2.7.3) 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). one or more modules do not have a button, then select Selftest to reinitialize
"Passed" status. the system.
If the problem persists, call Bio-Rad
Technical Support.
ABORT button pressed The Stop button has been clicked during The run has been interrupted and may
a run. be continued or aborted completely (see
Section 3.12).
Aborting plate [...]. The operator clicked the Stop button You can decide to resume the run for the
during a run and then, in the Pause remaining plates or abort it completely.
dialog box, requested that the processing
of one or more plates be aborted (see
Section 3.12).
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 you sure you want to abort all of The run is paused and you have clicked Click Yes or No as required (see Section
the plates? the Abort worklist button (confirmation 3.12).
message).
Are you sure you want to ABORT The run is paused and you have clicked Click Yes or No as required (see Section
plate [...]? the Abort plate(s) button (confirmation 3.12).
message).

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Problem / Message Circumstance / Possible cause Recommended actions

Are you sure you want to export You clicked the Export results button. See Section 3.18.
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.
Barcode IC error The barcode cannot be read. Check the correct position and
readability of the barcodes (see Section
3.2) and try again. If the error persists,
call your Bio-Rad Service Engineer.
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.
Colorimeter [...] not homed The X-motor of the colorimeter is not in Select the Selftest item in the Utilities
the home position. menu to initialize the EVOLIS again. If
the problem persists, call your Bio-Rad
Service Engineer. If this error message
comes up during a run, this run has to
be aborted (see Section 3.12).
Colorimeter background light level Typically occurs when light entered the Avoid direct exposure to sunlight, close
error measurement chamber. all housing doors and covers.
Select the Selftest item in the Utilities
menu to initialize the EVOLIS again. If
the error persists, call your Bio-Rad
Service Engineer.
COMGEN error [...]. RS232 connection faulty. Check that the connection between the
EVOLIS computer and the instrument is
satisfactory. Switch on the EVOLIS
instrument again and restart the
computer.
COMGEN error 0x0A - Target ---- Call your Bio-Rad Service Engineer.
overflow error
Crash recovery file detected. After power failure. No: System is reinitialized. Old worklist
Do you want to try and recover the will be deleted. Yes: The following
worklist? 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!
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.

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Problem / Message Circumstance / Possible cause Recommended actions

Error scheduling plate [...] The system is unable to program the Click OK and try and correct the problem
current worklist. This message is 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 3.19.
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.

No response to command [...]. General software error. Communication Click Retry. If the same message is
between the EVOLIS computer and the displayed again, switch off the computer
instrument is interrupted. and restart it. Switch off and restart by
pressing directly the ON/OFF switch
(cold boot), do not perform a proper
Windows shutdown. When the computer
restarts, answer the prompts ”....worklist
...?" and ”is the analyzer still running?”
accordingly. The system starts again
and continues with the worklist in
progress.

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Problem / Message Circumstance / Possible cause Recommended actions

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.
Patient IDs: [...] are being run using Some of the samples in your worklist will Click Yes if this is intentional. Otherwise
the same assay protocol multiple be tested twice with the same assay click No and review the worklist
times! (multiple selection). definition.
Are you sure you want to proceed?
Pipettor error 0x70 - Disposable tip The pipettor accidentally loses the tip Available recovery options are Retry or
dropped [...]. during a pipette or dispense step. Abort Plate. If you click Retry, the
* Please remove the tip from the pipettor picks up another tip and repeats
system. 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.
Plate ID verification error. Plate barcode cannot be read. Missing or Check that the barcode label is correctly
* Check that […] is in the carrier. faulty barcode, incorrectly selected attached on the left-hand side of the
* Check that the barcode label is barcode type. microplate (see Section 3.2, end of
correctly attached. Section) and try again.
If the error persists, you can always
enter the Plate ID manually in the Load
Plate dialog box (see Section 2.4.5).
Plate transport %1 motor movement Error in plate transport motor no. ... . Try to locate the cause of the resistance
error. (blocking) and eliminate it and click
1. Check plate transport for Retry. If the error persists, call your
obstructions Bio-Rad Service Engineer.
Plate transport carrier error Plate holder does not move far enough Click the Retry button. If the error
into the instrument, so that the sensor persists, the plate transport has to be
barrier is not triggered. adjusted new. Call your Bio-Rad Service
Engineer.
Plate transport error. Error in plate transport in case of Try to locate the cause of the resistance
1. Check for obstructions increased resistance. (blocking) and eliminate it and click
Retry. If the error persists, call your
Bio-Rad Service Engineer.
Please close the system flap 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.

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Problem / Message Circumstance / Possible cause Recommended actions

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.
RS232 write error - command: '%1' Error in interface between the EVOLIS Check the connections between the
computer and the EVOLIS instrument. EVOLIS instrument and the EVOLIS
computer. Check that the COM Port
selected in the software (select Utilities
| System Setup) corresponds to the
COM Port that is actually used to link the
instrument to the computer.
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.
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 cover opened Instrument cover is opened. Close the cover; otherwise the EVOLIS
cannot start processing the worklist.
System fluid LOW. Not enough system-liquid available. Refill the system-liquid container (see
Section 3.21).
System waste full. During initialization procedure or during Check that the small washer waste
* Empty the system 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, please
1 call Bio-Rad Technical Support.
Decontaminate all liquid waste as
described in Section 3.21.
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 3.21.
The disposable tips have been During the tip type detection. System After you have clicked OK the software
incorrectly loaded. detected large tips instead of small tips or displays the Load dialog box again so
vice-versa. that you can check and correct the
loading position of the tip racks (300 µl
and 1100 µl tips).

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Problem / Message Circumstance / Possible cause Recommended actions

The field is too small to accept the This message is usually displayed if you Make sure that Sample IDs (on barcode
amount of data you attempted to attempt to start a worklist in which one or labels or manually entered) do not
add. Try inserting or pasting less more Sample IDs exceed 20 include more than 20 alphanumeric
data. alphanumeric characters. characters (see Section 3.2).
Note: This message is always displayed
in English.
The password for that user has been After deleting a forgotten password. See Section 3.19.
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 try
pipettor shall need to be paused 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 plate transport cannot find a Plate transport has no information about Call your Bio-Rad Service Engineer.
route from its current position to its its present position.
next destination
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 3.18.
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) or the Delete (Test) buttons
patient information? instead of Delete All.
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 message
model. Check that there are opening a result file (*.res) on a separate and open the result file.
sufficient standards. computer (not the integrated system
computer).
Unable to store control file [...]. This error normally occurs only when Click OK to override the error message
opening a result file (*.res) on a separate and open the result file.
computer (not the integrated system
computer).

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Problem / Message Circumstance / Possible cause Recommended actions

Warning! Reagent [...] has expired! The expiry date of the reagent you loaded Click OK to close the message. You can
(Expiry date [...].) is exceeded. The message tells you when 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.
Washer reagent level low error Not enough wash buffer left. Refill the wash buffer (see Section
2.4.1). When done, click the Retry
button. Then you may continue.
Washer waste pump error Error in washer waste pump. Check connections and vacuum flask
cap for leaks. If the error persists, call
your Bio-Rad Service Engineer.

You are not authorized to undertake You do not have sufficient access rights See Section 3.19.
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 abort some plates, see Section 3.12.
load or delete the additional plates.
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

A 1. Technical Specifications ................................................................118

A 2. Accessories and Consumables .....................................................121
A 3. Data Label ........................................................................................124
A 4. Flags .................................................................................................125
A 5. Revision History ..............................................................................126

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A 1. Technical Specifications

Dimensions & Weight

Instrument Size (HxWxD) 950 x 1130 x 760 mm
Instrument Weight 130 kg
Table (optional) Size (HxWxD) 550 x 1200 x 800 mm

Electrical
Line voltage, auto-switch 100 - 240 V
Frequency 50 - 60 Hz.
Input Power max. 0.5 kVA
Fuse Rating 4 A / 250 V

Operating conditions
Operating ambient temperature 15° C - 25° C
Relative humidity level max. 90 % R.H. - non condensing
Heat emission 1440 BTU/h
Noise level 65 dB(A) at 1 m

Sample Pipetting
Primary sample capacity Up to 198 samples
Dilution capacity 90 tubes or 3 dilution plates
Sample tube diameter 9 - 16 mm
Sample tube height Up to 100 mm
Sample dilution Serial dilution possible via tubes or
plates
Carry-over N.A. (disposable tips)

Reagent Pipetting
Reagent containers Bio-Rad original reagent bottles
Reagent vials volume 3, 8, 15, 30, 60, 125 ml
Last min. reagent preparation Yes
Reagent identification Internal Barcode Scanner
Lot & expiration management Yes

Disposable Tips
On-board capacity (walk-away) 480 tips of 300 and/or 1 000 µl
In-process reload Yes
Reuse partial tip racks option Yes
Tip waste capacity > 1 000 tips
Tip detection (mechanical) Yes

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Pipetting Features
Patient samples (100 µl/ well) < 18 min./ plate
Reagent (100 µl/ well) < 4 min./ plate
Dilution (1:10) < 23 min./ plate
Dilution (1:100) < 45 min./ 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%

System-liquid 1 x 10 L

Pipetting Detection
Colorimetric Yes (Verify Dispense)
Capacitive Yes (Aspirate Check)
Pressure Monitoring (barometric) Yes (Aspirate only)

Internal Barcode Scanner

Pos. Ident. of samples and reagents Yes
Microplate Ident. Yes
Reads Interleaved 2 of 5, Code 3 of 9, IATA 2
of 5, Industrial 2 of 5, UPC A & E, EAN
8 or 13, Code 128, Pharmacode,
Codabar, EAN Addendum 2 or 5
External Barcode Scanner Optional

Shaking
On the plate transport unit Yes (linear, variable time, fixed
frequency)
In the incubators Yes (linear, variable time, fixed
frequency)
In the photometer Yes (linear, variable time, fixed
frequency)

Incubation
Room-temperature incubators 4
Heated incubators 4 (independent, heatable from room-
temperature + 5°C up to 50° C)
Precision +/- 1.4° C
Accuracy +/- 1.0° C
Incubation time Programmable
Heating-up (room-temperature -> 37°C) < 30 min.
Temp. display & tracing Yes

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Washer
Capacity 1 plate, up to 3 wash buffers
Manifold 8 channels (16 needles)
Plate type (bottom shape) Flat, u- or v-shaped
Wash mode Plate & strip
Cycles 1-9
Soak time (plate mode) 0 - 999 sec.
Dispense volume 200 - 1000 µl/well
Residual volume < 6 µl in F bottom
Features top wash and bottom wash, sweep,
soak, variable pump speeds
3 Wash Buffer bottles, auto-switch 3x2L
Level sensors (on wash buffer) Yes
Alarm (insufficient liquid) Yes
Liquid waste capacity 1 x 10 L
Level sensor (on liquid waste container) Yes
Alarm (waste full) Yes
Washer rinse liquid container 1x1L
Auto-rinse function Yes

Reader (photometer)
Read modes OD and Kinetic
Capacity 1 plate
Reading head 8 channels
Read time (full plate) < 15 sec.
Light source Halogen
Dynamic range 0 – 3.0 OD
8 filter wheel (equipped 405, 450, 492, 550, 620,
690 nm)
Reading method (beam) Single / double
Filter of over-range values Yes
Linearity (0 – 2.0 OD) 1%
Accuracy (0 – 2.0 OD) +/- 0.005 or 2.5 %

Data Processing
Computer (supplied)
User Interface Software under Windows 10 and
Windows 7
Monitor & Printer (supplied)

Communication
RS-232 Serial Port Yes
On-line (bi-directional) Import formats: ASTM, ASCII, ATBarco
Export formats: ASTM, ASCII,
SRIMPORT

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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.

Ordering Reference Description Part No

GENERAL CONSUMABLES
EVOLIS Tips 300 UL (X17280) Small tips 89611
EVOLIS Tips 1100 UL (X9600) Large tips 89612
ST Waste Bag (X1) Tip waste bag + cap (x1) 89586
ST Waste Bag (BoxX10), W/ Label
Tip waste bags + caps (x10) 89799
Biohazard
Microcide SQ® Decontamination solution
ST Setup and Cleaning Conc 90071
(236.6 ml - 8 fl oz.)
Reagent kit for performance evaluation
PE Kit Pipettor - Washer 89894
procedures on the pipettor and washer
ST Fuse, 4.0A/250V, 5X20 mm (Box/10) 10 EVOLIS Standard fuses 89608
RACKS / PLATE CARRIER
ST Reagent Rack 2, Ctrl Small reagent rack / control rack 89780
ST Reagent Rack 1, 7-15 ml Medium reagent rack 89781
ST Reagent Rack 0, 30-60 ml Large reagent rack 89782
ST Sample Rack with Numbering 1-20 Standard sample rack for 20 tubes 90433
Rack Alu 22 positions (for tube 12/13 mm) Sample rack for 22 tubes 97240
Rack position adaptors for medium
EVOLIS Insert (X6) 91488
reagent rack
ST ASSY, Plate Carrier "A1" Carrier frame for microplate 89679
EVOLIS Dilution Area Wedge Metal support for dilution plate 97215
EVOLIS SAMPLE RACK TRAY Workbench tray for sample racks 90328
BOTTLES / CONTAINERS
1 liter wash buffer bottle with red cap,
ST Bottle 1L, Wash Buf, Red W/O Filter 89657
without filter
1 liter wash buffer bottle with black cap,
ST Bottle 1L, Wash Buf, Black W/O Filter 89658
without filter
2 liter wash buffer bottle with blue cap,
ST Bottle 2L, Wash Buf, Blue W/O Filter 89661
without filter
2 liter wash buffer bottle with yellow cap,
ST Bottle 2L, Wash Buf, Yellow W/O Filter 89662
without filter
Spare 1 liter wash buffer bottle with
ST Bottle Square PVC 1000 ML, W/Cap 89934
ordinary cap
Spare 2 liter wash buffer bottle without
ST Bottle Square PVC 2000 ML, W/O Cap 89935
cap
EVOLIS cap, Wash Bottle 2L Ordinary cap for 2 liter wash buffer bottle 90282
ST Bottle, Aspirate, 1 Vacuum flask 89659
ST Bottle, Aspirate, 2 Trap flask 89660
ST Container, System-liquid, 10L System-liquid container 89984
Liquid waste container with cap and
ST Assy Waste Container 89650
tubing
Spare liquid waste container with ordinary
ST Container, Waste, 10L 89985
cap

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Ordering Reference Description Part No

EVOLIS Reagent Bottle 15ml X72 15 ml reagent bottle with cap 89776
EVOLIS Reagent Bottle 30ml X72 30 ml reagent bottle with cap 89777
EVOLIS Reagent Bottle 60ml X72 60 ml reagent bottle with cap 89778
EVOLIS Reagent Bottle 125ml X72 125 ml reagent bottle with cap 89779
23 ml reagent containers with V shaped
SARSTEDT REAGENT V-VIAL, 500/PK 12013142
bottom, with cap
PHOTOMETER
ST 405nm Optical Filter Photometer filter 89689
ST 450nm Optical Filter Photometer filter 89688
ST 492nm Optical Filter Photometer filter 89687
ST 532 nm Optical Filter Photometer filter 90397
ST 550 nm Optical Filter Photometer filter 89962
ST 570 nm Optical Filter Photometer filter 90349
ST 620nm Optical Filter Photometer filter 89686
ST 650nm Optical Filter Photometer filter 89684
ST 690nm Optical Filter Photometer filter 89685
ST Lamp, 13.8V, 30W Photometer lamp 89604
MISCELLANEOUS ACCESSORIES
CD with EVOLIS Software, APF and
Evolis CD SW+APF+IFU° 93489
Manuals
READER VERIF PLATE Photometer verification plate 89690
INCUBATOR VERIFICATION TOOL V2 IVT - Incubator verification tool 91069
UPS Nitram US 9602 2KVA Uninterruptible Power Source Device 90065
BARCODE LABELS FOR RACKS
ST SET, BC Labels Sample Rack Barcodes for standard sample racks (T) 91730
LABELSET, Sample Rack Alternativ Barcodes for other sample racks 90353
ST Set, Barcode Labels Reagent Rack Barcodes for small reagent rack (control
90290
(CTRL) rack)
ST Set, Barcode Labels Reagent Rack (7-
Barcodes for medium reagent rack 90289
15 ml)
ST Set, Barcode Labels Reagent Rack (30-
Barcodes for large reagent racks 91731
60 ml)

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Barcode Labels for non-barcoded reagent bottles

Barcode labels for non-barcoded Bio-Rad reagent bottles can be ordered
separately from Bio-Rad. Ordering references for these barcode labels can
be found in the "EVOLIS APF Manual" (this manual is included on the EVOLIS
installation CD - REF 93489).

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A 3. Data Label

Figure 53: Back panel label

Symbols
Reference / Catalog number

Serial number

Date of manufacture

Fuse rating

Manufacturer

In vitro diagnostic medical device

Caution, consult accompanying documents.

Product certified for both the U.S. and Canadian markets,

to the applicable American and Canadian standards
(NRTL).

Consult instructions for use

Compliant with European RoHS Directives (Restriction of

Hazardous Substances)
CE Marking (Regulation (EU) 2017/746 of the European
Parliament and of the Council of 5 April 2017 on in vitro
diagnostic medical devices - IVDR).
WEEE - (Directive 2012/19/EU of the European Parliament
and of the Council of 4 July 2012 on waste electrical and
electronic equipment).
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.

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A 4. Flags

In the table below, the Result calculation column indicates whether a result
will be calculated by the EVOLIS system for a flagged sample (depending on
the type of flag). The Recalculation possible column indicates whether the
operator has the possibility to "force" the system to recalculate results for
flagged samples, even if the initial results were not calculated.
For more information on interpreting and recalculating flagged results, see
Sections 3.14 and 3.15.

Flag Meaning Result Re-

calculation calculation
possible
SplRem Sample rack removed. No Yes

RgtRem Reagent rack removed. Yes Yes

CovOp Cover open. No Yes

ManID Manual ID. Yes Yes

NoLiq No liquid detected. No No

InsLiq Insufficient liquid detected. No No

Clot Clot detected. No No

PipErr Pipettor hardware error. No No

ManPip Manually pipetted resource. Yes Yes

VCFail Validation criteria failure. No No

VDFail Verify dispense failure. No Yes

IncKO Incubation overrun. No Yes

REAG EXP Reagent Expired. Yes Yes

P_max_high, Pressure monitoring flags. No No

P_min_low,
P_stop_high,
P_static_high,
P_static_low,
P_mean_low

flagged (displayed in red) This flag NA NA

replaces multiple flags when
results in the Combined Report
are displayed in Matrix format.

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A 5. Revision History

The table below lists all the changes introduced in this version of the manual
compared to the previous version. For further details on these changes,
please call Bio-Rad Technical Support.

Section (or page) Change

New in Version 2.4 of September 2021
Page VIII Revised Safety Instructions Section (added paragraph about reporting serious incidents)
Section 1.2 Revised User Profile Section
Section 1.5 Revised Installation Section
Section 1.5.1 New First Login Section
Section 1.5.2 New Files Types and Default Directories Section
Section 2.1.2 Revised Start-Up Section
Section 2.5 Revised Run Section
Section 2.7.1 Revised Unload / End of Run Maintenance Section
Section 2.7.2 New Log Off Section
Section 3.16 New Network Connection and Cybersecurity Section
Section 3.17 Revised Import Section
Section 3.18 Revised Export Section
Section 3.19 Revised User Management Section
Section 3.19.1 New Windows User Groups and User Access Rights Section
Section 3.19.2 New EVOLIS User Groups and User Access Rights Section
Section 3.19.3 New Password Management Section
Section 3.22 New Software Maintenance Section
Appendix A3 Revised Data Label Section
New in Version 2.4 of January 2021
Section 1.1 Revised Intended Use Section
Appendix A1 Revised Technical Specifications Section (Windows 10)
Appendix A2 Revised Accessories and Consumables Section
New in Version 2.3 of July 2020
Page IX Revised Warning Labels Section
Appendix A3 Revised Data Label Section (new data label; NRTL update)
New in Version 2.3 of September 2019
Page II Added Trademarks and Warranty paragraphs
Page V Revised About this Manual Section (added reference to this Revision History Section)
Revised Bio-Rad Technical Support Section (added paragraph about BRiCare remote
Page V
technical support)

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Section (or page) Change

Revised Typographical Conventions Section (and added Abbreviations' list, moved from
Page VI
Appendices)
Page IX Revised Warning Labels Section (moved from Appendices)
Section 1.1 New Intended Use Section
Section 1.2 New User Profile Section
Revised Instrument Description Section (added cross-references to the Technical
Section 1.3
Specifications and to the Warning Labels Sections)
Revised Software Overview Section (final Note moved to Section 1.5 and new paragraph on
Section 1.4
the Language of the software user interface)
Section 1.5 New Installation Section
Section 2.1 Revised Getting Started Section (Warning added)
Section 2.1.2 Revised Start-Up Section (Note added)
Section 2.4.5 Revised Test Plates Section (Note added)
Section 2.5 Revised Run Section (Warning expanded)
Revised Understanding / Validating Result Reports Section (new paragraph on Result
Section 2.6.1
calculation)
Section 3.1 Revised APF upgrades paragraph (Note added)
Section 3.2 Revised Barcodes Section (added information in Sample barcodes paragraph)
Section 3.3 Revised Samples Section (new paragraphs on Sample type and Sample volume)
Revised Reagents and Controls Section (new paragraphs on Reagent, controls and
Section 3.4
calibrators, and on Insufficient reagents/ controls/ wash buffers; Note added)
Section 3.11 Added cross-reference to the revised Reagents and Controls Section
Revised Users Rights and Passwords Section (added cross-reference to the new User
Section 3.18
Profile Section and Note)
Section 3.20 Revised Washer maintenance paragraph (two Notes added)
Section 3.21 New Disposal of an EVOLIS System Section
Section 4 Revised Troubleshooting Section (Note added)
Revised Troubleshooting Section (new error message on Sample IDs exceeding 20
Section 4
characters)
Revised Technical Specifications Section (Line voltage and Frequency specifications
Appendix A1
aligned with values on Data label)
Appendix A3 Revised Data Label Section (new data label; WEEE Directive update)
Former Appendix 4 - Symbols and Abbreviations deleted (see new Warning Labels Section
---
and revised Typographical Conventions Section)
Appendix A5 New Revision History Appendix

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