Liaison XL

LIAISON® XL
I0050
LIAISON®XL LAS
I0050LAS
User Manual
Revision D
200/008-930 (03/2012)
DISCLAIMER
The information contained herein is based on experience and knowledge relating to the subject matter as acquired by
DiaSorin S.p.A.
DiaSorin is not liable for any loss or damage, including consequential or special damages resulting from the use and or
misuse of the contained information be it negligence or other fault.
This document refers to access at the highest level. Working with lower level access may cause a lack of some
functionalities.
LIAISON®XL may only be used by authorized and trained personnel.
This document cannot be considered substitutive of official trainings supported by DiaSorin.
In the event of problems or doubts about using the system, contact the local support.
A document that states the list of LIAISON®XL Software Versions that are covered by the present User Manual
revision will be provided separately.
DiaSorin S.p.A.
Strada per Crescentino snc - 13040 Saluggia (Vercelli) - Italy
www.diasorin.com
DiaSorin S.p.A. 2012. All rights reserved

Table of Contents
Table of Contents
Table of Contents ............................................................................................I
1 Introduction ..................................................................................... 1-1

1.1 Description ......................................................................................................... 1-1
1.2 Customer Support .............................................................................................. 1-2
1.3 Proprietary statement ........................................................................................ 1-2
1.4 Authorization and disclaimers about Documentation .................................... 1-3
1.5 LIAISON® XL Warranty ....................................................................................... 1-4
1.6 DiaSorin Warranty .............................................................................................. 1-4
1.7 Messages, Notes and Symbols ......................................................................... 1-5
1.8 Hazard Instructions .......................................................................................... 1-11
1.9 Safety residual risks for User.......................................................................... 1-24
LIAISON XL - Instructions for use TOC - I

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Table of Contents
1.10 Instrument Labelling and Safety Labels......................................................... 1-34

1.11 Operational Precautions and limitations........................................................ 1-58
1.12 Installation of the System ................................................................................ 1-61
1.13 Removal of the System .................................................................................... 1-62
2 PC security measures..................................................................... 2-1

2.1 Introduction ........................................................................................................ 2-1
2.2 Unauthorized Local Access .............................................................................. 2-1
2.3 Malware ............................................................................................................... 2-2
2.4 Unauthorized access via network ..................................................................... 2-4
2.5 System update .................................................................................................... 2-4
2.6 Local/network printing ....................................................................................... 2-5
2.7 Remote access ................................................................................................... 2-6
2.8 Privacy ................................................................................................................ 2-7
3 Measuring Principle of the LIAISON®XL Immunoassays ............ 3-1

3.1 Explanations for Steps of Assays .................................................................... 3-1
3.2 Measuring Principle ........................................................................................... 3-4
TOC - II LIAISON XL - Instructions for use

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Table of Contents
3.3 Measuring Function Description ...................................................................... 3-5

3.4 Calibration (quantitative) ................................................................................... 3-6
3.5 Calibration (qualitative) ..................................................................................... 3-8
4 System Description......................................................................... 4-1

4.1 Overview ............................................................................................................. 4-1
4.2 Use of the Modules .......................................................................................... 4-16
4.3 Accessories and Consumables ...................................................................... 4-43
5 Use of the System ........................................................................... 5-1

5.1 Safety and Hints ................................................................................................. 5-1
5.2 Typographical Conventions .............................................................................. 5-2
5.3 Daily activities plan ............................................................................................ 5-5
5.4 Start-up ............................................................................................................... 5-6
5.5 Check Cuvettes, Disposable Tips, Starter Reagents and Liquid Containers 5-9
5.6 Load Patient Samples or Controls and Assign Assays ................................ 5-51
5.7 Integrals, Calibrators, Ancillary reagents ...................................................... 5-70
5.8 Start Worklist .................................................................................................... 5-85
LIAISON XL - Instructions for use TOC - III

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Table of Contents
5.9 Results .............................................................................................................. 5-87

5.10 Routine errors ................................................................................................ 5-102
5.11 Unloading........................................................................................................ 5-103
5.12 Shut Down/End of Day Maintenance ............................................................ 5-111
6 Software Functions ......................................................................... 6-1

6.1 General ................................................................................................................ 6-1
6.2 Header ............................................................................................................... 6-13
6.3 Main Category Loading.................................................................................... 6-17
6.4 Main Category Results..................................................................................... 6-37
6.5 Main Category Events ...................................................................................... 6-79
6.6 Main Category Definitions ............................................................................... 6-86
6.7 Main Category System ................................................................................... 6-114
6.8 Main Category Diagnostics ........................................................................... 6-137
6.9 Main Category Maintenance .......................................................................... 6-141
6.10 Main Category Status .................................................................................... 6-148
6.11 External Backup Viewer................................................................................. 6-160
TOC - IV LIAISON XL - Instructions for use

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Table of Contents
7 Quality Control (QC) ....................................................................... 7-1

7.1 Working Method ................................................................................................. 7-1
7.2 Working Procedure for Users ........................................................................... 7-6
7.3 Functions of the Quality Control Application .................................................. 7-7
8 Maintenance .................................................................................... 8-1

8.1 Safety and Hints ................................................................................................. 8-1
8.2 Scheduled Maintenance Tasks ......................................................................... 8-6
8.3 Light Check......................................................................................................... 8-6
8.4 Preparation of Liqui-Nox® solution ................................................................... 8-7
8.5 Load and Unload the Cleaning Solution Bottle ............................................... 8-7
8.6 Clean the pipettor probes ................................................................................ 8-12
8.7 Clean the analyzer interior .............................................................................. 8-13
8.8 Clean the primary and the intermediate tanks............................................... 8-14
8.9 Clean the covers .............................................................................................. 8-30
8.10 Cuvette removal ............................................................................................... 8-30
8.11 Automated actions performed by the system ............................................... 8-31
LIAISON XL - Instructions for use TOC - V

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Table of Contents
9 Troubleshooting and Error Messages .......................................... 9-1

9.1 Error Messages and Information Messages .................................................... 9-1
10 Technical Data ............................................................................... 10-1

10.1 Power Requirements ....................................................................................... 10-1
10.2 Laser of the Bar-code Scanner ....................................................................... 10-2
10.3 Computer and Connections ............................................................................ 10-3
10.4 Dimensions ....................................................................................................... 10-5
10.5 System Clearance ............................................................................................ 10-6
10.6 Weight ............................................................................................................... 10-7
10.7 Environmental Conditions............................................................................... 10-7
10.8 Noise ................................................................................................................. 10-8
10.9 Temperature Range ......................................................................................... 10-8
10.10 Water quality..................................................................................................... 10-9
11 Appendix A: Cuvette Instruction for Use .................................... 11-1

11.1 Intended Use..................................................................................................... 11-1
11.2 Materials Provided ........................................................................................... 11-1
TOC - VI LIAISON XL - Instructions for use

Rev. D
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11.3 Handling ............................................................................................................ 11-1

11.4 Storage .............................................................................................................. 11-2
11.5 Warnings and Precautions for Users ............................................................. 11-2
11.6 Meaning of Symbols ........................................................................................ 11-3
12 Appendix B: Tip Instruction for Use ............................................ 12-1

12.1 Intended Use..................................................................................................... 12-1
12.2 Materials Provided ........................................................................................... 12-1
12.3 Handling ............................................................................................................ 12-1
12.4 Storage .............................................................................................................. 12-2
12.5 Warnings and Precautions for Users ............................................................. 12-2
12.6 Meaning of Symbols ........................................................................................ 12-3
LIAISON XL - Instructions for use TOC - VII

Rev. D
1 Introduction
1 Introduction
This manual was created to assist the laboratory user with the utilization of the LIAISON®XL and LIAISON®XL LAS chemiluminescence
analyzer (see chapter 1.1.1). This manual includes specific definitions as well as handling and maintenance of the instrument.
1.1 Description
The LIAISON®XL is a fully automated chemiluminescence analyzer, performing the complete sample processing (sample pre-dilutions,
sample and reagent dispensing, incubations, wash processes) as well as the measurement and evaluation. The instrument is controlled via
the PC LIAISON®XL software. This software, which was specifically designed for this purpose, allows the user to process the pre-defined
assays. The clear structure with intuitive user-guidance allows simple and quick operation of daily routine jobs.
For LIAISON®XL LAS see chapter 1.1.1.
1.1.1 Intended Use

This manual covers the following products:
 LIAISON®XL: Diagnostic System that measures chemiluminescence. It is intended strictly for professional In-vitro-Diagnostic use. It is
to be used only with Chemiluminescence Immunoassays, authorized by DiaSorin S.p.A. for the LIAISON®XL Analyzer.
 LIAISON®XL LAS: Modified version of the LIAISON®XL Diagnostic System, designed to allow compatibility with certain types of
laboratory automation systems.
All the references to LIAISON®XL are intended also for LIAISON®XL LAS. Specific references to LIAISON®XL LAS
are explicitly indicated.
LIAISON XL - Instructions for use Page 1-1

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1 Introduction
Please check with DiaSorin S.p.A the compatibility between a lab automation system and LIAISON®XL LAS.
1.2 Customer Support
If you have any questions about the LIAISON®XL Diagnostic System, please contact your local DiaSorin Customer Support Representative to
get answers to your inquiries.
1.3 Proprietary statement
The LIAISON®XL System software programs and system documentation are protected by copyright laws. All rights are reserved. The
software and manual were developed solely for use with the LIAISON®XL and LIAISON®XL LAS System and for in vitro diagnostic
applications as specified in the operating instructions.
The information, documents and related graphics published herein (the "Documentation" or “Document”) are the sole property of DiaSorin
S.p.A. Permission to use the Information is granted, provided that:
 use of the Documentation is for operating DiaSorin products by DiaSorin trained personnel or informational use only;
 the copyright notice appears on all copies;
 the Documentation is not modified in any way; and
 no graphics are used separately from accompanying text.
Each person assumes full responsibility and all risks arising from use of the Documentation. The Documentation may include technical
inaccuracies or typographical errors. DiaSorin S.p.A.reserves the right to make additions, deletions, or modifications to the Documentation at
any time without any prior notification.
Page 1-2 LIAISON XL - Instructions for use

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1 Introduction
1.4 Authorization and disclaimers about Documentation
The information contained herein is based on experience and knowledge relating to the subject matter as acquired by DiaSorin S.p.A.
This Document refers to access at the highest level. Working with lower level access may cause a lack of some functionality.
The user manual and the LIAISON®XL Chemiluminescence analyzer are to be used by authorized personnel only. Operate the Instrument
following the indications and procedures described in the operating instructions for the LIAISON®XL Analyzer.
Follow all warnings, cautions, and notes indicated on the LIAISON®XL Analyzer and in the operating instructions. Failure to do this may result
in human injuries or damage to instrument.
No part of this document may be reproduced, stored, retrieved, or transmitted in any form or by any means without the prior written permission
of DiaSorin S.p.A.
All samples, if any (printouts, graphics, displays, screens, etc.), are for information and illustration purposes only and shall not be used for
clinical or maintenance evaluations. Data shown in sample printouts and screens do not reflect actual patient names or test results.
The Documentation was developed to be used by DiaSorin S.p.A trained personnel, by other persons knowledgeable or experienced with the
operation and service of the product identified, or under the direct supervision and with cooperation from DiaSorin S.p.A technical sales or
service representatives.
This Document cannot be considered substitutive of official trainings supported by DiaSorin.
In no event shall DiaSorin S.p.A or its affiliates be liable for any damages or losses incurred in connection with or arising from the use of the
Documentation by persons not fully trained by DiaSorin S.p.A. This limitation shall not apply to those persons knowledgeable or experienced
with the operation and service of the product identified, or under the direct supervision and with cooperation from DiaSorin S.p.A technical
sales or service representatives.
In the event that any user of the Information should make any questions, comments, suggestions, ideas or any other kind of oral, written or
electronic feedback to DiaSorin, any information submitted therewith shall be considered non-confidential, and DiaSorin shall be free to
reproduce, edit, publish or otherwise use such information for any purposes whatsoever including, without limitation, the research,
development, manufacture, service, use, or sale of products incorporating such information and no liability will be borne by DiaSorin in
connection with its content, including its truthfulness and accuracy and its non-infringement of any other person's proprietary rights.
Updates to the Documentation may be provided in either paper or electronic format. Always refer to the latest documents for the most current
information.
In the event of problems or doubts about using the system, contact your local support representative.

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1 Introduction
1.5 LIAISON® XL Warranty
DiaSorin warrants instruments sold by DiaSorin or any of its related company to be free from defects in workmanship and materials during
normal use by the original purchaser. Unless otherwise expressly agreed to in writing by DiaSorin, this warranty shall continue for a period of
one year, commencing twenty-one (21) days from the date of shipment to the original purchaser, or until title is transferred from the original
purchaser, whichever occurs first (the "Warranty Period").
If any defects occur during the Warranty Period, contact your DiaSorin S.p.A Service Representative immediately, and be prepared to furnish
information including the serial number, the model number, and pertinent details concerning the defect.
This Warranty does not cover defects or malfunctions which: (1) are not reported to DiaSorin S.p.A during the Warranty Period and within one
week of occurrence; (2) result from chemical decomposition or corrosion; (3) are caused primarily by failure to comply with any requirements
or instruction contained in the applicable DiaSorin S.p.A User Manual; or (4) result from maintenance, repair, or modification, performed
without DiaSorin's authorization, (5) related to normal wear and tear.
DiaSorin S.p.A’s liability for all matters arising from the supply, installation, use, repair, and maintenance of the instrument, whether arising
under this Warranty or otherwise, shall be limited solely to the repair or (at DiaSorin S.p.A’s sole discretion) replacement of the instrument or
of components thereof. Replaced parts shall become the property of DiaSorin S.p.A. In no event shall DiaSorin be liable for injuries sustained
by third parties, consequential damages, and/or lost profits.
The warranty does not cover the software included in the system, which is subject to the warranty stated in the Software License Agreement.
The warranty is country dependent, based on local legal requirements.
The foregoing is the sole warranty made by DiaSorin S.p.A regarding the instrument, and DiaSorin specifically disclaims all other warranties,
expressed or implied, including the warranties of merchantability and fitness implied for a particular purpose.
1.6 DiaSorin Warranty
DiaSorin S.p.A makes no representations or warranties of any kind or nature with respect to the documentation. DiaSorin S.p.A hereby
disclaims all representations and warranties, whether express or implied, created by law, contract or otherwise, including, without limitation,
any warranties of merchantability, fitness for a particular purpose, title or non-infringement. In no event shall DiaSorin S.p.A be liable for any
damages of any kind or nature, including, without limitation, direct, indirect, special (including loss of profit) consequential or incidental
damages arising from or in connection with the existence or use of the information, regardless of whether DiaSorin S.p.A. has been advised
as to the possibility of such damages.

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1 Introduction
1.7 Messages, Notes and Symbols
The symbols described hereafter are used in the current manual, on the instrument and on its packaging.
1.7.1 Display of Warnings and Notes
The signal word "Danger" and the relating pictograph describe immediate dangers.
The non-observance of a danger warning is immediate and will result in death or at least serious irreversible injury.
Damage to the system or an adverse effect on the system function cannot be excluded.
The signal word "Warning" and the relating symbol describe potential dangers.
The non-observance of a warning is potential and can result in death or at least serious irreversible injury. Damage
to the system or an adverse effect on the system function cannot be excluded.
The signal word "Caution" and the relating symbol describe potential dangers/problems.
The non-observance of safety instructions can result in minor injuries. Damage to the system or an adverse effect
on the system function cannot be excluded.
The signal word “Caution” describes potential problems. The non-observance of a caution instruction can result in
damage to the system or an adverse effect on the system functionality.

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The signal word "Note" describes potential problems. The non-observance of notes can result in an adverse effect
on the system function.
1.7.2 Utilized Warning Symbols
Caution, risk of danger to person or damage to equipment! Consult instructions for use!
Biohazard!
Electrical hazard!
Laser hazard!
Caution, hot surface!
Mechanical hazard!
Cut injury hazard!
Automatic start-up!
No objects shall be put on the opening flaps.

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1 Introduction
Disconnect mains power connector before servicing!
Power Supply characteristics
Maximum supported load for extensible board.
Maximum load for printer support.
Water Tank
Wash Solution Tank
Cleaning Solution Tank
Liquid Waste Tank
Indication of the location of Main Switch / Emergency Stop button.

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1 Introduction
Close the drawer*
* available on instruments with cabinet drawers
Don’t step*
Stumble hazard*

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1.7.3 Other Symbols
Manufactured by
In Vitro Diagnostic
Lot number
Expiration date
Temperature limitations
CE mark
ID number
Serial number
Canadian Standard Association international compliance
RoHS compliance

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1 Introduction
Consult instructions for use
Disposal of Electrical and Electronic Equipment

In the European Union, electrical and electronic equipment must not be disposed of with
other household-type waste. It must be collected separately. Please observe the relevant
legal regulations effective in the respective country.
Left side HIBC Barcode (according to secondary data structure of ANSI/HIBC 2.3 – 2009
standard)
E.g: +$+22100000020%
Right side HIBC Barcode (according to primary data structure of ANSI/HIBC 2.3 – 2009
standard)
E.g: +E125I005000

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1 Introduction
1.8 Hazard Instructions
1.8.1 General Safety

The following safety instructions must be observed at all times, both before and during operation of the system.
The Instructions for use is provided for user safety and gives important instructions for the handling of the system described.
 Before starting use of the LIAISON®XL Diagnostic System, read the following explanations for safety carefully, and understand the
contents completely. User must be trained before being allowed to operate the system.
 Keep the Instructions for use near the system.
 When using reagents or chemicals, a properly well-ventilated room should be the responsibility of the user. Failure to comply may result in
health issues.
 For maintaining safety, do not modify the LIAISON®XL Diagnostic System, do not change the components or accessories, do not use
parts either than the specified, and do not remove the safety devices.
 Installation and service of the system or changes in the installation may never be performed by non-authorized persons not approved by
DiaSorin S.p.A. Multiple plug sockets different from the one as installed by DiaSorin or its representative personnel are not allowed.
 Do not perform any operations or functions not described in the operating instructions. If trouble occurs on the Diagnostic System, contact
DiaSorin S.p.A., or an authorized representative.
 Cautions indicated on the LIAISON®XL Diagnostic System and in the operating instructions are prepared after careful examination;
however, phenomenon beyond prediction may occur. When performing operation and maintenance, it is imperative to follow the
instructions correctly.
 It is mandatory to allow DiaSorin S.p.A. personnel, or an authorized representative, to perform all scheduled and exceptional interventions
on the LIAISON®XL Diagnostic System that have been indicated as necessary to guarantee the full operational conditions of the system.
 The Instructions for use must be accessible to the user at all times.

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To guarantee the full operational conditions of the LIAISON®XL Diagnostic System, it is mandatory to allow
DiaSorin S.p.A. personnel, or any field service authorized representative, to perform all scheduled (two
preventive maintenances per year) and unscheduled interventions, whereby required under particular
circumstances, including but not limited to inappropriate use, over extraordinary workloads or any inconsistent
use in respect of DiaSorin guidelines or recommendations. Ordinary analyzer workload is considered up to 500
determinations (assay results) per day.
Failure to adhere to the IFU may result in harm for the user or 3rd party persons, damage to the system or
adversely affect assay result. See section Operational precautions and limitations, chapter 1.11.
1.8.2 Liability
The LIAISON®XL Diagnostic System is designed and manufactured in accordance with the safety requirements for electronic and medical
systems. It is the operators’ responsibility to comply with local and national law's regulations and laboratory procedures for installation and
operation of the instrument.
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 information contained herein is based on experience and the best knowledge relating to the subject matter as acquired by DiaSorin S.p.A.
DiaSorin is not liable for any loss or damage, including consequential or special damages resulting from the use and or misuse of the
contained information be it negligence or other fault of personnel and/or contractors.
 The instrument may only be used in accordance with its intended use.
 Use only the consumables and accessories described herein (e.g. disposable tips, cuvettes).
 The manufacturer assumes no liability for any damages, including those to third parties, caused by improper use or handling of the
system.

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Improper use of the system may result in wrong assay results, damage of the system and personal injury.

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1.8.3 Electrical Hazards

The LIAISON®XL Diagnostic System does not pose uncommon electrical hazards to operators if it is installed and operated without alteration
and is connected to a power source that meets required specifications. See Electrical requirements in chapter 10.1.
National rules and local regulations for the safe electrical operation of the system must be observed.
Basic electrical hazard awareness is essential to the safe operation of any system. Only qualified personnel should perform electrical
servicing.
Elements of electrical safety include, but are not limited to the following:
 Where appropriate, the Analyzer is installed with additional external switch for residual current circuit-breakers with over-current
protection.
 Where appropriate it is integrated in UPS device.
 Use only connection and extension cables with a protective conductor and sufficient capacity (performance, power) to connect the system
and the peripheral devices to the mains supply.
 Use a properly grounded electrical outlet of correct voltage and current handling capability.
 Never interrupt the grounding contacts.
 Grounding of the system and its peripheral devices to the same protective earth potential must be ensured.
 The multi plug possibily supported can be used only as installed by DiaSorin or its representative personnel. Do not add any other device
to the supplied multi plug.
 Determine and correct the cause of a blown fuse or thrown circuit breaker before attempting to resume operation of the system.
 Do not disconnect any electrical connection or service any electrical or internal components while the power is on.
 Keep liquids away from all connectors of electrical or communication components.
 Do not touch any switches or outlets with wet hands.
 Keep the floor dry and clean under and around the Analyzer.
 Disconnect the Analyzer power cord before cleaning major liquid spills.
 Clean spilled fluids immediately.

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 Damaged connecting cables must be replaced immediately.
 No objects may be placed on the connecting cables.
 Connecting cables must be routed so that they cannot be squeezed or damaged.
 Connecting cables must be routed so that they do not lie in accessible or drivable areas.
 Immediately separate the defective system from the mains supply, if a safe usage is no longer possible.
 Secure the defective system against reconnection.
 Label the defective system clearly as being defective.
 Switch off the system, separate it from the mains supply and protect it against restarting. When system is secured start cleaning,
disinfection, decontamination, maintenance or repair operations.
 Ensure that the system is free from personnel and that all covers are attached and closed before reconnecting the system to the mains
supply.
 Ensure the positioning of the system during installation is so that the power supply and mains switch are easily accessible.
Electrocution/Fire Hazard!
Non-observance of rules and regulations may cause serious personal injury with lethal consequences and material
damage.
Improper connection of the system and the peripheral devices to mains supply can cause serious personal injury
with lethal consequences and material damage (e.g. fire).
Damaged connecting cables can cause serious personal injury with lethal consequences and material damage
(fire).
Defective systems can result in serious injury with lethal consequences and material damage (e.g. fire).
In case of accidental spilling or dropping on electrical or electronical parts or connections, switch off the system and
unplug from the mains supply. When the system is secured, call Service support.

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Danger of Electrocution or Mechanical Injury

If the system is not separated from the main supply before maintenance operations, serious injury with lethal
consequences due to electrocution may occur. Additionally, there is the danger that the system starts and may
cause injury (e.g. contusion, cuts etc.) to the person working with the system.
Danger due to Improper Positioning of Installation

Improper placement of the system can cause accidents with serious injuries with lethal consequences, fire or
serious system damages because the system cannot be switched off or be separated from the main supply.
1.8.4 Physical Hazards
1.8.4.1 Laser Light Hazards
 Never look directly into the laser beam.

 Do not introduce optical devices into the system.
 Remove watches and reflective jewelery before operating the laser.
 Caution during operation and testing the laser (bar-code scanner) must be taken due to the laser class (class 2).
Eye Injury due to Laser Radiation

Laser radiation can cause eye irritations when looking into the laser beam for a long period of time.
Wrong usage of operating elements or of adjustments or the non-observance of processes can cause a dangerous
emission of laser radiation.

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1.8.4.2 Heavy objects
 Use proper lifting techniques when handling full tanks (water, wash, and waste), the full waste basin and the full waste bin.
 Use care when handling the tanks to reduce the risk of injury.
 Use care when handling the waste basin and the waste bin, in order to avoid falls of contaminated materials.
1.8.4.3 Trip Hazards
The LIAISON®XL Diagnostic System is equipped with power cords and various computer connectors. To avoid tripping hazards, ensure cords
are properly stowed.
In the event of a damage, prejudice or personal injury occurring in connection with the use of the LIAISON®XL
Diagnostic System, user shall immediately contact the local DiaSorin Representative.
1.8.5 Mechanical Hazards

The LIAISON®XL Diagnostic System is an automated system that operates under computer control. As with most automated equipment, there
is potential for injury and bodily harm from moving mechanical components whenever the system is in operation.
The LIAISON®XL Diagnostic System minimizes mechanical hazards by providing guards to protect against accidental contact with moving
components, and encoding the software with safety features.
During operation of the Analyzer, user is potentially exposed to the following moving mechanical components:
 Pipettor arms and probes;
 Cuvette loading mechanism (auger);
 Cuvette orientation mechanism (sorter).
Basic elements of mechanical safety include, but are not limited to:
 Avoid contact with the sharp metal edges.
 Never bypass or override a safety device.
 Keep all protective covers and barriers in place.

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 Never perform manual tasks on the work surface of the system.
 Never allow any part of your body to enter a range of mechanical movement during system operation.
 Do not wear articles of clothing or accessories that could catch on the system.
 Keep pockets free of items that could fall into the system.
 The right pipettor probe is sharp and potentially contaminated with infectious material. Avoid contact with the probe tip.
 Do not attempt to resolve a cuvette jamming in the cuvette loader and sorter area when the Analyzer is running.
 Use caution when performing maintenance or cleaning procedures.
 Be aware that, in the event of a system malfunction or an unexpected sequence of movements, reflex actions could occur, causing injury.
 Select the placement of the system so that the ventilation slots are not blocked or covered.
 Select the placement of the system so that air can circulate.
 Never cover ventilation slots.

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1.8.6 Biological Hazards

Performing the following activities user may be exposed to potentially infectious materials:
 Handling samples, reagents, calibrators, and controls;
 Cleaning spills;
 Handling and disposing of waste;
 Performing maintenance procedures;
 Performing cleaning or decontamination procedures.
The following information will help the user in minimizing the impact of this exposure.
User should consider all clinical samples, reagents, calibrators, controls, and used reaction vessels and consumables (e.g. tips, cuvettes) that
contain human-sourced material as potentially infectious. User should consider all system surfaces or components that have come in contact
with human-sourced material as potentially infectious. No known test method can offer complete assurance that products derived from human-
sourced material will not transmit infection. Therefore, all products derived from human-sourced materials and system components exposed to
human-sourced materials should be considered potentially infectious.
Precautions include, but are not limited to the following:
 Observe local and national provisions, legislation and laboratory regulations.
 Use appropriate disposable gloves.
 Use an appropriate lab coat.
 Use an appropriate eye protection.
 Avoid contact between skin/mucous membrane and samples/test reagents or parts of the instrument.
 Do not pipette by mouth.
 Do not eat, drink, smoke, apply cosmetics or handle contact lenses when handling human-sourced material or contaminated system
components.
 Use proper personal protective equipments when interacting with the probe for maintenance or cleaning procedures.
 Clean, disinfect and decontaminate the system immediately if potentially infectious material has been spilled.

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 Any reagent spills should be washed with a chemical use sodium hypochlorite solution with 0.5% active chlorine (e.g. dilution 1:10 of a
solution at 5% active chlorine) and disposed of as though potentially infectious.
 All samples, biological reagents and materials used in the assays must be considered potentially able to transmit infectious agents. They
should therefore be decontaminated and disposed of in accordance with the prevailing regulations and guidelines of the agencies holding
jurisdiction over the laboratory, and the regulations of each Country.
 Liquid waste must be decontaminated with a chemical use sodium hypochlorite solution with 0.1% active chlorine (e.g. dilution 1:50 of a
solution at 5% active chlorine) for at least half an hour.
 Do not use broken or chipped tubes or bottles.
 Observe the instructions in the package inserts for a correct use of the reagents.
Risk of infection!
All internal parts of the system, that are not defined as user interfaces and for which specific procedures are described,
must be treated as being potentially infectious. Improper handling of infectious parts can cause skin irritations,
illnesses and possibly death.
Disposal of Infectious Waste

Potential infectious material and all parts that may come in contact with potential infectious material must be disposed
according to the local and national provisions, legislation and laboratory procedures.

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1.8.7 Chemical Hazards
User may be exposed to hazardous chemicals when handling reagents, calibrators and controls.
Exposure to hazardous chemicals is minimized by following instructions provided in the assay-specific documentation (such as a package
insert) and on product-specific labels, and product-specific MSDS (Material Safety Data Sheets).
In general, observe the following precautions when handling chemicals:
 Consult MSDS for safe use instructions and precautions.
 Avoid contact with skin and eyes. If contact with material is anticipated, wear impervious gloves, protective eye wear, and clothing.
 Maintain good housekeeping. Do not eat, drink, or store food and beverages in areas where chemicals are used.
 Seek medical attention if irritation or signs of toxicity occur after exposure.
1.8.8 Spill clean-up

Clean spills in accordance with established biosafety practices and follow instructions in the MSDS (Material Safety Data Sheets). In general,
safe work practices for cleaning spills include:
 Wear appropriate personal protective equipment, such as gloves, eye wear and lab coat.
 Absorb the spill with absorbent material.
 Wipe the area clean with an appropriate disinfectant such as a chemical use sodium hypochlorite solution with 0.5% active chlorine (e.g.
dilution 1:10 of a solution at 5% active chlorine).
1.8.9 Waste handling and disposal

Each facility is responsible for labeling all waste tanks and characterizing its waste stream to ensure waste is disposed in accordance with the
appropriate local regulations.
See the manufacturer's assay-specific documentation (such as a package insert or reagent application sheet), the product-specific label, or
the product-specific MSDS (Material Safety Data Sheet).

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1.8.10 Caution on electromagnetic wave interference
1.8.10.1 Electromagnetic wave interference given by LIAISON®XL to other equipment
The LIAISON®XL Analyzer has been designed and manufactured in compliance to the applicable EMC standards.
Use the cables attached at the installation for connection between the devices in the system. The proper use of the specified cables minimizes
electromagnetic wave interference.
Installation and service of the system or changes in the installation may never be performed by non-authorized persons not approved by
DiaSorin S.p.A. Movable multiple plug sockets different from the one installed by DiaSorin personnel are not allowed.
However, there is no guarantee that the LIAISON®XL Analyzer will not cause electromagnetic wave interference.
a. When the LIAISON®XL Analyzer may be the cause, turn off the power of this Instrument and check radio and television
reception.
b. If it is improved, the LIAISON®XL Analyzer probably is the cause.
1.8.10.2 Electromagnetic wave interference that may be given to the LIAISON®XL Analyzer
If the LIAISON®XL Analyzer is used near equipment that generates strong electric and magnetic field, noises may enter the Instrument to
affect the performances and functions.
Use the cables attached at the installation for connection between the devices in the system. The proper use of the specified cables minimizes
electromagnetic wave interference.
Installation and service of the system or changes in the installation shall be performed only by authorized persons approved by DiaSorin
S.p.A. Movable multiple plug sockets different from the one installed by DiaSorin personnel are not allowed.
However, there is no guarantee that the LIAISON®XL Analyzer will not be affected by electromagnetic wave interference.

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a. When other equipment may be the cause, turn off the power of the equipment and check the functions of the LIAISON®XL
Analyzer.
b. If they are improved, interference from the equipment is probably the cause.
Try the following to correct the issues.
a. Move the LIAISON®XL Analyzer further away from the equipment that may be the cause.
b. Connect the power cord of the LIAISON®XL Analyzer to an outlet that is on a different circuit from the equipment that may be the
cause.
c. Check the electromagnetic wave interference does not affect the other equipment, which is connected with this Analyzer.
Transient Emissions and Interference Resistance

The instrument meets the requirements described in standard IEC 61326 on transient emissions and interference
resistance.
 This instrument was developed and tested according to CISPR11 Class A. It can cause radio interference in
domestic environment. In this case it may be required to take action to eliminate such interference.
 Before setup and operation of the instrument, the electromagnetic environment should be evaluated.
 Do not use the instrument in the vicinity of sources with excessive electromagnetic radiation (e.g. unshielded,
deliberately operated high frequency sources) since they could interfere with the proper operation of the
instrument.

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1.9 Safety residual risks for User
The aim of this section is to bring to user’s attention the status of residual risks despite the inherent safe design measures, safeguarding and
complementary protective measures adopted by the Manufacturer to lower the risks to an acceptable level.
User must read carefully this section to understand the residual risks and learn the recommended instructions to work safely with the
LIAISON®XL Diagnostic System.
If further clarification should be needed, it is recommended to contact the local DiaSorin representative.
1.9.1 Definitions
(a) "hazard" means a potential source of injury or damage to user’s health;
(b) "danger zone" means any zone within and/or around machinery in which a user is subject to a risk to his/her health or safety;
(c) "exposed person" means any user wholly or partially in a danger zone;
(d) "user" means the person or persons operating, maintaining and cleaning the machinery;
(e) "risk" means a combination of the probability and the severity of an injury or damage to health that can arise in a hazardous situation;
(f) "guard" means a part of the machinery used specifically to provide protection by means of a physical barrier;
(g) "protective device" means a device (other than a guard) which reduces the risk, either alone or in conjunction with a guard;
(h) "intended use" means the use of machinery in accordance with the information provided in the instructions for use;
(i) "reasonably foreseeable misuse" means the use of machinery in a way not intended in the instructions for use, but which may result from
readily predictable human behaviour.

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1.9.2 Inherent safe design and manufacturing process
The Analyzer has been designed and manufactured following the applicable regulations and harmonized standards.
In regards of risk management, the Analyzer has been designed and manufactured applying a risk management process, based upon the ISO
standard 14971:2007 (Medical devices – Application of risk management to medical devices). By the application of the standard, through an
iterative process of risk analysis, the manufacturer has:
 Determined the limits of the Analyzer, which include the intended use and any reasonably foreseeable misuse;
 Identified the hazards and the associated hazardous situations that can be generated by the use of the machinery;
 Estimated the risks for hazardous situations, taking into account the severity of the potential harm (injury or damage to health) and the
probability of its occurrence by the application of an appropriate FMEA (Failure Mode Effect analysis) methodology;
 Evaluated the risks, with a view of determining whether risk reduction has been required;
 Reduced the risk for hazardous situations by the identification, implementation and verification of the effectiveness of appropriate risk
control measures.
The above mentioned process will be actively maintained by the Manufacturer until the retirement of the LIAISON®XL Diagnostic System from
the market. The Manufacturer has also established procedures to review post production information in order to ensure the appropriate safety
degree and to maintain the IVD Analyzer always adequate to the so called “state of the art” as per, and in compliance with, the European
Community Directive 98/79/EC related to IVD Medical Devices.
The LIAISON®XL Diagnostic System has been designed and constructed so that it is fitted for its function, and can be operated, adjusted and
maintained without putting persons at risk when these operations are carried out under the conditions foreseen, but also taking into account
any reasonably foreseeable misuse thereof.
The aim of measures taken is to eliminate any risk throughout the foreseeable lifetime of the machinery including the phases of transport,
assembly, dismantling, disabling and scrapping.
In selecting the most appropriate methods, DiaSorin has applied the following principles, in the given order:
 to eliminate or to reduce risks as far as possible (inherently safe machinery design and construction),
 to take the necessary protective measures in relation to risks that cannot be eliminated,
 to inform users of the residual risks due to any shortcomings of the protective measures adopted,
 to indicate whether any particular training is required and specify any need to provide personal protective equipment.

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Where possible, the Analyzer has been designed and constructed to prevent abnormal use if such use would create a risk.
Where appropriate, the instructions draw the user's attention to ways — if the experience has shown might occur — in which the machinery
should not be used. The instructions have to be carefully read, paying attention to all warnings, taking into account the way the Analyzer has
to be operated and which are the abnormal uses forbidden.
The LIAISON®XL Diagnostic System is supplied with all the special equipments and accessories essential to allow safely using and
maintaining. No other tools from the ones supplied by the Manufacturer must be used; use of unapproved items may endanger user’s safety
and/or health.
In no event shall DiaSorin S.p.A or its affiliates be liable for any damages or losses incurred in connection with or
arising from the use of unapproved items used to operate or maintain the Analyzer.
1.9.3 Materials and products

The materials and products of which the Analyzer is made and the agents and reagents used on it do not endanger the user’s safety or health,
apart from remaining biohazard and chemical risks and the interference they might cause with electrical and mechanical risks. In particular, in
the areas where biological fluids are used, the Analyzer has been designed and constructed to prevent risks due to filling, use, recovery or
draining.
1.9.3.1 Waste liquid tank
When user removes one waste liquid tank to empty it, he/she has to disconnect the level sensor first and then the tubing; reinserting the tank
in the Analyzer, user is required to reconnect the tubing first and then the level sensor, to prevent the risk of leakage due to a missing
reconnection of the tubing.
If one waste tank level sensor is not correctly reconnected, the Analyzer stops using it. The same occurs if the level
sensor is out of order.
A joint connector may be installed in some instrument configurations in place of the separate sensor and liquid
connector. The joint connector allows to manage the insertion/ removal of waste sensor and tubing as a single task.
See chapter 5.5.6.3 for details.

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For safe use it is strictly forbidden:

 to alter or modify the level sensor function and/ or use Analyzer without liquid waste tank correctly connected to
the tubing, apart if a direct drain connection (see chapter 4.2.9.6) is used for waste disposal;
 to use cracked or broken tanks.
During a liquid waste tank disconnection, the user has to prevent dripping of infectious liquid from the tubing waste, when unplugging it. The
user has to wear gloves, lab coat and use paper to dry the tubing. In order to minimize the possibilities of contamination of cabinet areas, a
specific slot of the waste basin shall be used to position disconnected waste sensors and tubings (applicable to instruments with cabinet
drawers).
After the tubing and level sensor have been disconnected, the user is asked to carefully handle the tank to prevent spillage and corner, edge
or side shocks.
If an accidental tank shock should occur, before reassembling the tubing and sensor, the user is asked to accurately check the plastic surface
to detect whether any crack or break occurred. If any crack or break is detected, the tank must not be used and it must be replaced.
The assessment about residual risks has highlighted that a tank crack generated by a shock may also not be detected by the user. In this
case a basin can prevent the spillage; because of shape, dimensions and volumes, it does not produce other risks for handling or mechanical
interference.
1.9.4 Design of Analyzer to facilitate handling

Where appropriate, according with remaining risks evaluation results, tanks are equipped with handles in order to facilitate gripping; because
of shape, dimensions and volumes, it does not produce other risks for handling or mechanical interference.
1.9.5 Ergonomics
The LIAISON®XL Diagnostic System has been designed taking into account the ergonomic principles to reduce at minimum discomfort,
fatigue, physical and psychological user’ stress under the intended conditions of use.

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1.9.6 Safety and reliability of control systems
Control systems are managed in the Analyzer control software. A fault in the hardware or in the software of the control system does not lead
to hazardous situations: in case of HW or SW fault the Analyzer cannot work.
Software interface of Analyzer is validated against foreseeable risks: errors in the control system logic do not lead to hazardous situations.
The software is designed to help the user in following the right sequence of operations to be performed to run the Analyzer. Reasonably
foreseeable human errors during operation do not lead to hazardous situations. The Analyzer cannot start un-expectedly because there are
several operations to perform before having it started.
The parameters of the machinery do not change in an uncontrolled way, and may not lead to hazardous situations: the system set up
parameters are not accessible to users. They are managed by Field Service Engineers only.
If the stop command has already been given, the Analyzer cannot be prevented from stopping.
No moving parts of the machinery or pieces held by the Analyzer can fall or be ejected: there are no parts that fall as consequence of a stop
command.
Where applicable, a tip could be ejected into the appropriate waste solid bag as a consequence of a stop command. It does not lead to risks
because it is part of the intended use of the Analyzer.
It is strictly forbidden using the Analyzer with the solid waste container closed without the solid waste bag on. A SW counter notifies the user
when the solid waste bag is full and needs to be replaced. To ensure an appropriate replacement of the waste bag without affecting the
ongoing operation of the Analyzer, the system allows 15’ from the opening to the closing of the solid waste container, due to the presence of
an intermediate case. User is asked to wear gloves when handling the solid waste container and bag.
1.9.6.1 Main Cover Opening before or after a “moving” status – safe use
The interlock protective device (i.e the cover sensor) remains fully effective or gives a stop command also in case is out of order. In particular
intended uses, because of specific requirement related to initializing, diagnostic, service or maintenance status and different access profile
levels, opening the interlocked cover does not set the Analyzer to a stop command. In details, the System behaves as follows:
 Whenever the system is in status “initializing” and the main cover will be recognized as open, then the System stops moving; in case the
user access level is an end-user level (strictly lower than Field Service Engineer level) the consequence will be that, within a few seconds,
the Analyzer will stop all movements;
 The same would be true if the main cover opening occurs in combination with the status “maintenance”, in case the user access level is
an end-user level (strictly lower than Field Service Engineer level);

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 The same would be true if the main cover opening occurs in combination with the status “running”, in case the user access level is an end-
user level (strictly lower than Field Service Engineer level);
 In case the main cover opening occurs in combination with the status “service” (i.e. during a diagnostic task), then the open cover
condition will be ignored, as there is a pop-up (given at the beginning of a diagnostic action) that reminds to close covers;
 If the SW will not be communicating with the Analyzer (e.g. if the PC should be switched off), then the Analyzer will halt itself anyway
(within about 4 seconds);
 If the main cover is opened while the pipettor arms are working during a routine, the System will stop the ongoing routine and get the
status “halted”; the routine interruption may be avoided pressing the button “Pause” and waiting for no less than 30’’ before opening the
cover. In both cases there is no risk of moving pipettor arms while the cover is open.
It is strictly forbidden to alter and / or to modify the intended use conditions and functions of interlocked cover. When
open cover condition is ignored, it is strictly forbidden to touch moving parts while running or getting closed to them
with hands, arms, shoulders or face/ head.
No operation must be performed touching moving parts while they are running!
The EMERGENCY STOP can be obtained by cutting energy supply acting on the MAIN SWITCH.

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An emergency stop device would not lower the risk because it would not reduce the stopping time in comparison with
the Analyzer’s main switch.
1.9.6.2 Emergency stop – safe use
The following conditions may occur and have to be followed after an emergency stop is given:
 after the instrument is turned back on, the software believes that the communication with the Analyzer is lost and it will interrupt the
communication;
 whenever the PC and the Analyzer are turned on together, there will be no movement at all, and the communication will be kept off; in
order to start the communication up, the only way is that the user will press the “Init” button in the software;
 any other action performed before or after turning on the Analyzer will not start the communication up, therefore nothing will move on the
machinery;
The emergency stop function of the main switch is available and operational at any time, regardless of the operating
mode.
1.9.7 Failure of the power supply

The interruption, the re-establishment after an interruption or the fluctuation in whatever manner of the Analyzer power supply does not lead to
dangerous situations.
Particular attention must be paid on the following aspects:
 the Analyzer does not start unexpectedly: a SW command given by the user is always necessary to restart movements of the Analyzer;
 the setting parameters of the Analyzer do not change in an uncontrolled way when in case power supply fluctuations or failures should
occur, not therefore leading to hazardous situations; such parameters are not erasable by the electrical power interruption;
 the Analyzer is not prevented from stopping if the command has already been given;
 no moving parts of the Analyzer or pieces held by it can fall or are ejected in case of power supply failure;

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 automatic or manual stopping of the moving parts, whatever they may be, are unimpeded;
 the protective devices remain fully effective or give a stop command also in case they are out of order (please: read also chapter 1.9.6.1)
1.9.8 Protection against mechanical hazards

The durability of the materials used is adequate for the nature of the working environment foreseen by DiaSorin S.p.A., in particular as regards
the phenomena of fatigue, ageing, corrosion and abrasion. To date, there is no evidence of parts showing to be weak.
Insofar as their purpose allows, accessible parts of the Analyzer have no sharp edges, no sharp angles and no rough surfaces likely to cause
injury.
The moving parts of the Analyzer are designed and constructed in such a way as to prevent risks of contact which could lead to accidents or,
where risks persist, are fitted with guards or protective devices or warning signals.
A remaining mechanical hazard is related to moving parts.
Even if the residual mechanical risk is deemed acceptable, the user might be exposed to biohazard risk in case of
minor injury (e.g. cut or scratch).
To prevent mechanical risk, user must not stand close to moving parts of the Analyzer when the routine is running.
To prevent biohazard risk, user must wear the personal protective device as per Good Laboratory Practice and
according to local regulations.
For safe use it is strictly prohibited:

 to touch moving parts of the Analyzer while they are running;
 to touch Analyzer parts, accessories or tools potentially infected without wearing the personal protective devices;
 to assemble / disassemble tanks tubings without wearing glasses or a protective mask or visor;
 to handle samples, reagents or any other biological liquid or agent without wearing coat and gloves;
 to enter the loading bay for sample racks with hand or fingers while the Analyzer is running;

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 to alter and or to modify fixed or interlocked movable guards;
 to use the Analyzer in end-user intended use without fixed or interlocked movable guards.
1.9.9 Protection against electrical hazards

The LIAISON®XL Diagnostic System is designed, constructed, equipped and installed in such a way that all hazards of an electrical nature
are or can be prevented. The Analyzer is designed and constructed to prevent or limit the build-up of potentially dangerous electrostatic
charges.
Where appropriate, the Analyzer is installed with additional external switch for residual current circuit-breakers with over-current protection.
Where appropriate it is integrated in UPS device.
National rules and local regulations for the safe electrical operations of the system must be strictly observed.
The Analyzer is not designed and constructed to be operated in a potentially explosive atmosphere. The Analyzer
must not be installed and used in a laboratory with potentially explosive atmosphere.
End user is responsible to assess that such requirement is respected before allowing Diasorin S.p.A. or its affiliates
to install the Analyzer.
For safe use it is strictly prohibited:

 To interrupt the electrical grounding contacts;
 To add any other device to the multi plug supplied with the Analyzer (if available) with the exception of those
installed by DiaSorin authorized representatives;
 To damage connecting cables or not replacing them if damaged;
 To place objects on the connecting cables;
 To leave connecting cables in accessible or drivable areas where they can become additional risk;

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 To not immediately disconnect the Analyzer from the main supply, if a safe usage is no longer possible;
 To cover the switches or have them inaccessible;
 To use the Analyzer if any switch or controls device is damaged.
1.9.10 Protection against noise hazards

Analyzer is designed and constructed in such a way that risks resulting from the emission of airborne noise are reduced to the lowest level,
taking account of technical progress and the availability of means of reducing noise, in particular at source. For technical data regarding noise
emission, refer to chapter 10.8.
The A-weighted emission sound pressure level at workstations does not exceed 70 dB(A).

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1.10 Instrument Labelling and Safety Labels
This section provides information on the instrument labelling, with particular focus on the safety labels.
Safety labels are used on the LIAISON®XL system and in the documentation to identify potentially dangerous conditions. Before starting to
use the Analyzer, user has to identify these labels and understand the type and degree of potential hazard.
Missing Warnings
Missing or unreadable warning labels or type labels can result in non-identified dangers which can cause serious
personal injury and/or material damage.
 Check the system for missing or unreadable warning labels and type labels.
 Missing or unreadable warning labels or type labels must be replaced.
1.10.1 Instrument Serial Label

Instrument Serial Label (LIAISON®XL LIAISON®XL LAS
Figure 1-1) reports general information about the system (refer to paragraph 1.7.2 for the detailed explanation of symbols): it contains also the
Instrument Serial Number, the unique identifier of each instrument.

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LIAISON®XL LIAISON®XL LAS
Figure 1-1: Instrument Serial label
Instrument Serial Label is placed in the cabinet, at the top right corner of the wall separating the tank area from the PC area (Figure 1-2).

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Figure 1-2: Instrument Serial label positioning
1.10.2 Power Label

The Power Label, reporting all the characteristics of the power supply to use, is placed on the right side cover, near the switch of the system
(Figure 1-3).

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Figure 1-3: Power label
1.10.3 Emergency Stop Label

In case of emergency, the Analyzer can be automatically stopped using the main switch available at the right side of the instrument. In order to
inform properly the user about the positioning of the emergency stop, a specific label is placed on the front side of the right blind cover (Figure
1-4).

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Figure 1-4: Emergency stop label
1.10.4 Laser Hazard Labels

A laser hazard label is positioned on the left side of the sample loading bay (Figure 1-5).

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Figure 1-5: Sample Area labels
1.10.5 Pipettor Label

Generic warning labels are positioned on left and right arms (Figure 1-6).

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Figure 1-6: Pipettor labels
1.10.6 Solid Waste Labels

A bio-hazard label is placed on the front cover of the solid waste drawer (Figure 1-7).

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Figure 1-7: Solid Waste Drawer label
The same bio-hazard symbol is also placed on solid waste bags and on both lateral walls of the solid waste bin (Figure 1-8, see also chapter
4.2.9.8).
All these symbols indicate the users the presence of contaminated materials (tips and cuvettes) inside.

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Figure 1-8: Solid Waste Bin label
1.10.7 Liquid Waste Labels

A bio-hazard symbol is placed on the front side of each liquid waste tank (Figure 1-9), together with a label indicating the content. These
symbols indicate the users the presence of contaminated liquids inside.
In case of instruments not equipped with cabinet drawers, the same bio-hazard symbol is also placed at both sides of the front face of the
waste basin (Figure 1-9, see also chapter 4.2.9.5), informing the user to pay attention to spillage of contaminated liquid inside.
In case of instruments equipped with cabinet drawers, the same symbols are placed on the floor of the waste basin (see chapter 1.10.17).

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Figure 1-9: Liquid Waste tank and basin labels
1.10.8 Water Label

A symbol, indicating the presence of water inside, is placed on the front side of the water tank and intermediate tank (Figure 1-10).

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1.10.9 Wash Label

A symbol, indicating the presence of wash solution inside, is placed on the front side of the wash solution tank and intermediate tank (Figure
1-10).
A red line indicating the 9 L level is also available on the front side of the tank: this reference helps the user during the preparation of the wash
solution.
For the preparation of the wash solution, refer to the Instruction for Use (IFU) provided with the System Liquid bottles.
1.10.10 Cleaning Solution Label

A symbol, indicating the presence of cleaning solution inside, is placed on the front side of the tank (Figure 1-10).

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a) Tanks b) Intermediate tanks

Figure 1-10: “Water”, “Wash” and “Cleaning Solution” labels
1.10.11 “Do not open cover” Label

It is strictly forbidden to open the left top cover of the instrument while the system is running; as a reminder, a label containing this message
(Figure 1-11) is applied to the front of the top cover (Figure 1-12).
The label is available in all different languages supported by LIAISON®XL system; during the installation of the system, the field service
engineer takes care of applying to the cover a label in the proper language.

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Figure 1-11: “Do not open cover” label – English version
Figure 1-12: “Do not open cover” label positioning

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1.10.12 Top Cover Labels

A caution and a bio-hazard label, informing the user about the possible dangers associated to the contact with the inner parts of the
instrument, are placed on the internal face of the top cover (Figure 1-13).
Risk of infection!
As indicated by the labels applied to the interior face of the left top cover, all internal parts of the system, that are not
defined as user interfaces and for which specific procedures are described, must be treated as being potentially
infectious. For this reason:
 Open the left top cover only if strictly necessary.
 Wear appropriate protection devices (disposable gloves, lab coat, eye protection) before coming into contact with
the internal parts of the system.
Figure 1-13: Top Cover labels

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In order to prevent possible hand crushings during the opening/ closure of the top covers, two specific warning labels are placed on the
available metal bar, respectively under the left (Figure 1-14.a) and the right (Figure 1-14.b) top covers.
a) b)
Figure 1-14: “Danger of crushing hands” labels

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1.10.13 Extensible board label

A label with the indication of the maximum tolerated load is placed into the right front corner of the extensible board (Figure 1-15).
Figure 1-15: Extensible board label
1.10.14 Printer support label

A label with the indication of the maximum supported load is placed into the right front corner of the printer support (Figure 1-16Errore.
L'origine riferimento non è stata trovata.).

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Figure 1-16: Printer support label

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1.10.15 Flap Labels

No objects shall be put on the flaps of reagent area, sample area and starter area when they are opened. In order to avoid possible
misunderstandings of users, a specific label is applied to the flaps (Figure 1-17, Figure 1-18 and Figure 1-19).
Bio-hazard labels are also applied to the sample and reagent flaps, informing the user to pay attention to the possible presence of spills of
infectious liquids caused by sample or reagent improper handling.
Figure 1-17: Flap labels – Sample Area

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Figure 1-18: Flap labels – Reagent Area
Clean immediately spills present on flaps, following what indicated in chapter 1.8.6 and 1.8.8.

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Figure 1-19: Flap label – Starter Reagent Area
1.10.16 Cuvette Reservoir Label

A red line indicating the maximum level of cuvettes that can be loaded without causing mechanical crashes of the system is available on the
cuvette reservoir (Figure 1-20).

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Figure 1-20: Cuvette reservoir label
1.10.17 Cabinet Drawer Labels

The following labelling applies only to instruments with cabinet drawers.
“Close the drawer” label informs the user to always close the drawers once the loading/ unloading of tanks is completed. A label is placed on
the top part of the handle of each drawer (Figure 1-21 and Figure 1-22, ref.a).
“Don’t step” labels inform the user that it is forbidden to step onto the drawers both when the tanks are inserted or extracted. A label is placed
on the floor of each tank slot (Figure 1-21 and Figure 1-22 ref.b).
“Stumble hazard” labels inform the user to pay attention not to fall down when the drawers are out of the cabinet. A label is placed on each
side of each drawer (Figure 1-22, ref.c).

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“Bio-hazard” labels inform the user to pay attention to spillage of contaminated liquid in the area of the waste basin occupied by waste tanks.
A label is placed on the slot of each waste tank (Figure 1-21, ref.d).
Figure 1-21: “Close”, “don’t step” and “bio-hazard” label positioning

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1 Introduction
Figure 1-22: “Close”, “don’t step” and “stumble hazard” label positioning

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1 Introduction
1.10.18 LAS Expansion Labels

“Danger of crushing hands” labels (Figure 1-23) are placed on each side of the LAS expansion module,informing the user not to put hands in
the area where the sample arm is moving (see also chapter 4.1.6).
These labels apply only to LIAISON®XL LAS system.
Figure 1-23: “Danger of crushing hands” labels for LIAISON®XL LAS

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1 Introduction
1.11 Operational Precautions and limitations
This section describes the operational requirements, precautions, and limitations to ensure user safety and accurate assay results.
User must follow these requirements to help ensure proper system performance.
Not following the requirements and precautions provided can impact the system and assay performance and may cause damage to the
system or adversely affect assay results.
1.11.1 General requirements
 Ensure the system is out of direct sunlight, heat and drafts, and away from any heat generating device. Exposure to heat and drafts can
interfere with the ability of the system to maintain an operating temperature that is within the acceptable range.
 Maintain the required space on all sides of the system. For more information about space requirements, see chapter 10.5. This space
buffer is essential for:
o Accurate temperature control of the system;
o Adequate cooling of electrical components;
o Easy access for disconnecting the power cord when required;
o Easy access for maintenance.
Danger due to Overheating

Improper positioning (installation or operation) of the system or improper environment may cause fire or serious
system damage in case of overheating.
 Leave the system power on continuously unless instructed otherwise in a maintenance or troubleshooting procedure, or unless an
emergency situation occurs.
 Perform maintenance procedures as recommended in chapter 8.
 Do not attempt any maintenance that is not specified in the documentation provided by DiaSorin S.p.A.
 In case of user injury, keep the potential contaminant agent for a subsequent analysis.

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1 Introduction
1.11.2 Forbidden foreseeable misuse
The following list includes (but is not exhaustive) a set of forbidden foreseeable misuses identified by the Manufacturer. The user must
carefully read below notes and follow the indicated safe way to operate to avoid risk of harm.
 Troubleshooting operations to resolve cuvette jamming performed while moving parts are active. Intended use: operation is allowed when
moving parts are inactive.
 Introduce body parts in the hazard area while the Analyzer is active with moving parts. Intended use: any needed operation is allowed
when moving parts are inactive.
 Operate the Analyzer without the solid waste bag and container onboard unless during waste bag replacement. Intended use: waste bag
and its container must be onboard unless during waste bag replacement.
 Operate the Analyzer with no liquid waste tank connected. Intended use: a liquid waste tank must always be connected before operating.
This restriction is not applicable if waste tubing is directly connected to a laboratory drain.
1.11.3 System operation
1.11.3.1 Precautions and Requirements before operation
Before beginning to operate the system, the user has to:

 Read this manual thoroughly to understand full functionality of the system and associated hazards.
 Read the sections of the reagent manufacturer's assay-specific documentation that are associated with:
o Warnings and precautions;
o Safety precautions.
 Verify that the solid waste container is equipped with the appropriate bag.
 Verify that the liquid waste containers are not full and correctly positioned.

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1 Introduction
1.11.3.2 Precautions during operation
 Keep all drawers and covers closed if not unless instructed otherwise in a described procedure.
 Do not disconnect any electrical connection while the power is on.
 Respond to system warnings during processing.
 Dispose of all waste material according to local regulations.
 Remove all samples and integrals from the system in case of an emergency stop.
1.11.4 Handling of reagents and consumables

See the manufacturer's assay-specific documentation (such as a package insert), the specific product label, the appendixes of the present
manual or the Material Safety Data Sheet (MSDS) for detailed information, including hazard symbols.
1.11.5 Handling of specimens

Carefully read the reagent manufacturer's assay-specific documentation and the chapter 5.6.1 of the present manual for information about
specimen collection, preparation, and storage.
Consider all system surfaces or components that have been in contact with human-sourced materials as potentially infectious.
1.11.6 Limitation of result interpretation

Any assay result supplied by the Analyzer does not aim to be released as medical advice or service without approval by authorized medical
personnel.
Assay results must be used with other clinical data such as patient symptoms, other test results, patient history, clinical data, information
available from clinical evaluation, and other diagnostic procedures.
The LIAISON®XL has been validated for its intended use only. However, errors can occur due to potential operator errors and LIAISON®XL
System technology limitations. If assay results are inconsistent with clinical evidence, additional testing is suggested to confirm the result.

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1 Introduction
Clot Detection System
Notwithstanding the Analyzer is equipped with a clot detection system, the user is not authorized by DiaSorin to load
consciously on the Analyzer sample tubes containing clots. Any default of the system related to a relevant
unappropriate use is in the sole responsibility of the user.
1.12 Installation of the System
Installation
Please note that the LIAISON®XL system may only be installed by authorized service personnel.
The Analyzer is not designed and constructed to be operated in a potentially explosive atmosphere. The Analyzer must
not be installed and used in a laboratory with potentially explosive atmosphere.
Customer is responsible to assess that the above requirement is respected before allowing DiaSorin S.p.A. or its
affiliates installing the Analyzer.
Note Technical Data

See chapter "Technical Data" (see chapter 10) for power requirements, computer and connections, installation
dimensions, weight and environmental conditions.

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1 Introduction
After the installation, the user of the LIAISON®XL system receives an installation qualification which documents the
proper installation of the LIAISON®XL system.
1.13 Removal of the System
If the system must be shipped to a new location, user shall contact the local DiaSorin field service representative for assistance.
Removal
The removal of the LIAISON®XL system must be performed by authorized service personnel.
Reinstallation
If the LIAISON®XL system moves within the plant, the authorized service personnel must perform a complete
reinstallation. If this reinstallation is omitted, this can cause damage of the system or irregular pipetting performance.

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2 PC security measures
2.1 Introduction
LIAISON®XL software is intended to be used in a controlled environment. Access is allowed only to trained and authorized users.
Nevertheless, usage of the system may undergo the risk of unauthorized access, leading to possible data loss, corruption or unauthorized
distribution.
Furthermore, updates to the software modules provided with the system (e.g. Operating System) must be distributed under controlled process,
to ensure that the system still behaves according to its intended use after the update.
This chapter describes the policy followed by DiaSorin and partners regarding how software elements are kept updated on systems installed
in end-user environment.
2.2 Unauthorized Local Access
2.2.1 Potential issues

Usage of the system is supposed only to trained and authorized users, who are supposed to follow the intended use of the system.
Unauthorized users could access or damage a computer system without the owner's informed consent. Consequences may be software and
data loss, corruption or unauthorized distribution.

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2.2.2 Protection measures

Access to the LIAISON®XL software is based on an access rights structure that allows system operation only to authorized users:
 operating the system, including access to any data, is only possible when typing a user identifier (made of “user name” and
“password”), that is unique for each end-user;
 “user name” is unique and cannot be re-assigned;
 both “user name” and “password” must be at least 8 characters long;
 for each “user name”, a “password duration” can be set; within the time frame based on “password duration”, the system will force the
user to change the “password” ;
 each user can change his/her own password;
 since, during installation of the system, for every user one default "password" will be inserted. it will be in the care of DiaSorin and
partners personnel to inform the end-users to modify her/his password at the first usage;
 it’s possible to define a “session expiration time”, i.e. a time interval after which the system logs-off the current user;
 end-users are logged into Operating System with a restricted account;
 end-users have no means to overcome the LIAISON®XL software application, i.e. they have no access to the Operating System and
other applications.
2.3 Malware

Usage of LIAISON®XL computer could lead to voluntary or involuntary introduction of malicious software, like virus, worms, spywares. This
malicious software (also called malware) is designed to infiltrate or damage a computer system without the owner's informed consent.
Consequences may be software and data loss, corruption or unauthorized distribution.
The introduction of such malicious software may occur:
 via network;

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 via a local USB device;
 via a local CD-Rom.

The state-of-art, worldwide spread approach is to provide a network firewall, a personal firewall and an integrated protection tool, generically
called antimalware. This approach looks not adequate for the LIAISON®XL computer for several reasons:
 the network firewall should be installed by network administrators, who in this case are end-users in regards to DiaSorin, therefore
DiaSorin has no control on the network firewall in terms of adequateness and update frequency;
 an antimalware must be kept up-to-date to be efficient, therefore almost daily updates are necessary; the sole mode to perform
frequent updates is to connect the computer to the internet, but:
o it cannot be ensured that all computers are connected to the internet, and also for those connected the connection cannot be
guaranteed upfront, while a malware can be introduced in any moment, even without internet connection;
o furthermore, a daily update of the antimalware would necessary mean that the updates are managed directly by antimalware
producer; therefore, the system configuration would be frequently updated, while DiaSorin could not guarantee a continuous
validation update in such continuously changing configuration; for example, an antivirus could unexpectedly recognize as
malware and delete files, that are necessary part of the validated environment, with the consequence of potential
malfunctioning of the software.
For all these reasons, an alternative integrated approach has been chosen:
 all the Operating System service and ports, that are not strictly required for the validated applications, will be blocked on the computer;
 the Operating System integrated firewall is activated, and configured such that all remote access to the system is denied (excluding
single specific ports needed for remote access authorized by DiaSorin);
 on the Operating System, the AutoRun for all USB storage devices will be disabled;
 it is prohibited to install any CD-Rom or Floppy Disk USB device;
 importing infected files from USB devices or CD-Rom is prevented by design, as end-users will have access on the computer to the
sole features allowed by the LIAISON®XL, i.e. will not have access to the Operating System features, and LIAISON®XL will allow to
import only files with specific proprietary extensions, disregarding any file with different extension;
 as additional protection, a specific and defined antimalware is installed on Liaison XL, mainly counting on its heuristic detection
methods. No other antimalware can be installed on Liaison XL.

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2.4 Unauthorized access via network

A LIAISON®XL computer connected to a network could be accessed by unauthorized persons, causing unpredictable effects on installed
software and data. Consequences may be software and data loss, corruption or unauthorized distribution.

A personal firewall is an application which controls network traffic to and from a computer, permitting or denying communications based on a
security policy.
The Operating System integrated firewall is activated, to ensure incoming access from a remote station is denied.
Theoretically, only computers connected to a network require a personal firewall, but for the sake of uniformity all computers provided with
Liaison XL will be protected with the Operating System personal firewall.
2.5 System update

The Operating System and the other software modules installed on LIAISON®XL computer may require to be updated from time to time, in
order to fix the discovered issues. Typically these are network vulnerabilities.

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Introducing continuous changes into the software modules introduces also a connected technical risk: the more changes are introduced, and
the more frequently they are, the more risks would accumulate in these regards. The described protection measures against external
intrusions is considered safe enough to face the known risks on the LIAISON®XL computer, that is strictly controlled and shielded even if
vulnerabilities would be discovered.
For these reasons, the Operating System and the other software modules installed on LIAISON®XL computer will be updated only if such
change is due to known technical reasons.
2.6 Local/network printing

There are two possible printing device types that can be used (only one per system):
 a local printer;
 a network printer.
The usage of a local printer, installed by DiaSorin on LIAISON®XL systems as “default printer”, requires installing printer drivers that could
affect the system with consequences like software and data loss.
The usage of a network printer, configured by DiaSorin on LIAISON®XL systems as “default printer”, requires to install printer drivers, that
may be not available for the LIAISON®XL computer, or to rely on Operating System printing service, that could affect the system with
consequences like software and data loss.

The local printer models, installed by DiaSorin on LIAISON®XL systems, are validated against their intended use. No printers that did not pass
the validation test will be installed on LIAISON®XL systems.

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The usage of a network printer will be supported:

 By installing printer drivers, provided that a printer model validation is carried out
o through the definition of a predefined set of “standard printer models”
o via dedicated validation for any additional printer model
 or relying on the Operating System printing service, without installing printer drivers
2.7 Remote access

LIAISON®XL systems may be connected to DiaSorin field personnel computers for the purpose of troubleshooting, customer support, and
software update. This will be managed through a dedicated application that requires software installation on both Liaison XL computer and
field personnel computers.
The connection may be established through two alternative approaches:
 via modem (point-to-point);
 via network (internet-based).
The availability of either modem connection, network connection or no connection may vary depending on countries and specific user
technical infrastructure.
Presence of such application could be lead to systems remotely accessed by unauthorized persons, causing unpredictable effects on installed
software and data. These situations could lead to consequences such as software and data loss, corruption or unauthorized distribution.

The remote connection will be hosted on a communication channel that undergoes cryptography. This prevents unauthorized users from
observing the channel.
DiaSorin guarantees that only authorized personnel are allowed to perform remote connection.

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2.8 Privacy

LIAISON®XL produces analytical results that refer to the health condition of patients.
Therefore, a potential risk of spreading health patient data may exist in regards to:
A. DiaSorin personnel (directly or indirectly involved in technical activities on the laboratory systems)
B. DiaSorin partners personnel (directly or indirectly involved in technical activities on the laboratory systems)
C. DiaSorin suppliers personnel (indirectly involved in technical activities on the laboratory systems)
Patient health data could be potentially available to the above mentioned personnel in the following situations:
1. during a technical intervention on laboratory systems, personnel of type “A” or “B” may need to access the LIAISON®XL software that
may contain patient health data, therefore check such data on the screen or print data as hard copy;
2. personnel of type “A”, “B” or “C” could retrieve patient health data as part of data exchanged in electronic or paper format, as part of
technical troubleshooting or maintenance activities that involve such personnel.
Furthermore, users different from above listed types could get in contact with patient health data.
Specific country regulations may require different means to overcome the listed potential issues.

The following measures are adopted in order to make the system compatible with the known regulatory requirements. Measures, that are
already listed and described in the present chapter and are in place to protect the patient health data, are not repeated here.
1. Both the patient health data and the demographics are encrypted;
2. If the patient health data have been exchanged on electronic format, this will happen through a encrypted channel;
3. It is possible to manually perform a complete back-up of patient health data;
4. It is possible to schedule automated back-up of patient health data;

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5. Sample identifier (SID) as well as patient identifier (PID), are conceived as an anonymous sequence of alphanumeric characters, that
the end-users may use in combination with their laboratory system, in which all the patient information are maintained, and particularly
the patient demographics;
6. The system can perform all the analyses without the need to insert the patient demographics;
7. The system allows to fill the fields "name" and "last name" present in the patient information,
8. In case the fields "name" and "last name" (patient demographics) are filled:
a. the access to such data will be restricted on the system to specific users, for whom the laboratory responsible people will ask
for activation (during system installation);
b. such measure regards the display on screen and the printed hard copies of such information, either directly from the Personal
Computer connected to the system, or from any other Personal Computer on which the LIAISON®XL software is installed, to
which the data bases are loaded after exporting from the system Personal Computer;
c. such measure covers both the direct visualization of information (e.g. the reading on screen of health data in combination with
demographics), and indirect search (e.g. the possibility to go back from health data to the SID and from the SID to the
personal data);
d. therefore, not explicitely authorized users will not have the rights to get access to patient demographics, not even in case the
user provided the database containing patient demographics.
As it regards the responsibilities of end-users, where local regulations require so, the end-user is responsible for the following behavior:
on LIAISON®XL SID and PID must not refer to the patient; such traceability shall be kept on the laboratory tracing systems.
In regards to the responsibilities of DiaSorin, where local regulations require so, DiaSorin responsibility is configured as follows:
a. DiaSorin will solicit the respect of the applicable privacy regulations, if there should be evidence that a LIAISON®XL is used without
compliance to the rules stated by applicable privacy regulations;
b. DiaSorin is not liable for improper use of data generated through the LIAISON®XL once data is outside of the boundaries of the
system itself, i.e. after data has been written, printed, or sent in electronic format to other laboratory systems.

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3 Measuring Principle of the LIAISON®XL Immunoassays
®
3 Measuring Principle of the LIAISON XL
Immunoassays
3.1 Explanations for Steps of Assays
Assays (also defined as “tests”) that run on the LIAISON®XL are divided into major categories:
 1-step assays
 2-step assays
 3-step assays
The numbered steps refer to the required amount of incubation sequences for a test. An incubation sequence is described as the amount of
times a sample must enter the incubator during the run.
These categories are described in detail below.

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3.1.1 Test Procedure 1-Step Assay
A 1-step assay refers to a test or assay that

has:
 1 incubation sequence (the time of
incubation may range depending on the
assay).
 1 wash sequence (the amount of washing
for this sequence is assay dependent).
Most assays that are 1-step have an incubation
time of 10 minutes. The figure below is only an
example. Pipetting sequences are also assay
dependent.
Figure 3-1: Example of test procedure “1-step assay”

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A 2-step assay refers to an assay that has:
 2 incubation sequences (the time of
incubation may range depending on the
assay).
 1 or 2 wash sequences (the amount of
washing for each sequence is assay
dependent).
Most assays that are 2-step have an
incubation time of 10 minutes each. The figure
below is only an example. Pipetting sequences
are also assay dependent.
Figure 3-2: Examples of test procedure “2-step assay”

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A 3-step assay refers to an assay that has:
 3 incubation sequences (the time of incubation may range depending on the assay).
 1 to 3 wash sequences (the amount of washing for each sequence is assay dependent).
3.2 Measuring Principle
 After the last wash cycle has been completed, the cuvette is transported into the Reader.
 When the cuvette reaches the position under the injection head, starter reagent 1 will be injected.
 After an appropriate pump delay time (2.55 sec minimum) the starter reagent 2 will be injected into the cuvette to start the
chemiluminescence reaction.
 After the measuring delay time of 0.1 sec, the measuring signal is obtained and integrated over the measuring period (3.0 sec for most
assays).
Figure 3-3: LIAISON®XL kinetic curve

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3.3 Measuring Function Description
 The chemically emitted light is measured by a selected highsensitive, low-noise photomultiplier [PMT]. The linear measuring range of the
photomultiplier is 300 – 650 nm. The light peak of the chemiluminescence is emitted at a wavelength of 420 nm.
 The PMT is operating as an ultra-fast photon counter. The pulses are amplified by a rapid electronic amplifier. A circuit, which suppresses
the PMT signal-noise is also implemented in the PMT box.
 Not the number of counts, but the Relative Light Units [RLU] are used as units of the measurement for the raw data.

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3.4 Calibration (quantitative)

Data reduction is performed using a master curve
with 2-point recalibration.
The starting point of data reduction is the master
curve, stored in the analyzer.
To compensate for differences between reagent
lots, different analyzers and environmental
conditions, assay calibration must be run and
validated according to the indications reported in
the assay Instructions for Use (indications may
vary per assays).
The measuring signals of the calibrators allow the
shift of all master curve points to a working curve,
corresponding with the actual conditions during
measurement. See the following example.
Figure 3-4: Calibration concept: example

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Brief description:  The stored master curve is generally defined with 10 master curve base points.
 Two calibrators with defined concentration values are measured. These measured signals (RLU) are compared with the master curve
signal of the corresponding calibrator concentrations.
 The relative difference between the measured RLU and the master RLU of the calibrators is calculated and a linear extrapolation is
performed between the recalculated RLU (Y-axis) and the logarithmic (Log) concentrations (X-axis).
 Based on appropriate compensation factors, a re-adjustment of the master curve points is made in order to achieve, by a “cubic spline
function”, the working curve.
Wrong Results!
For continuous safety of the diagnostic results, quality control measures are to be maintained, such as routine
controls or calibration issues, which are defined in this Operating Instruction.
 Safe and intended function of the LIAISON®XL Diagnostic System can only be expected with the use of
LIAISON®XL controls approved by DiaSorin S.p.A.
 Observe instructions in IFU of the reagents for Qualiy Control of the assay.

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3.5 Calibration (qualitative)
The calculation of a reference level, the cut off (CO), is performed as a linear combination of terms, dependant upon system base signal and
calibrators’ RLU. Formula applied is the following:
CO  a  RLU cal1  b  RLU cal 2  c

Analytical result is reported as index, the ratio of the unknown sample signal RLUsample vs the CO:
RLU sample
I
CO
Two kinds of QCal are possible, depending upon the number of calibrators:
1. in one point qualitative, only calibrator 1 is present: coefficients given are a and c only;
2. in two points qualitative, both calibrator 1 and 2 are present: all three coefficients a, b and c are given.
Validation of calibration is possible if results scored by the calibrator(s) lie within the related acceptance ranges.
After validation, the cut off is then calculated from the formula above.

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4 System Description
4.1 Overview
4.1.1 Materials required but not provided

In order to perform immunoassays, the following materials are needed beside specific assay kits:
LIAISON ® XL Cuvettes (code X0016).

LIAISON ® XL Disposable Tips (code X0015).
LIAISON ® XL Starter Kit (code 319200).
LIAISON ® Wash/System Liquid (code 319100).
LIAISON ® XL Waste Bags (code X0025).

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4.1.2 LIAISON® XL System
1 Left blind cover

2 Left top cover
3 Right top cover
4 Right blind cover
5 Front Module (throw in for cuvettes, drawers for disposable tip trays,
loading bays for samples, reagents and starter reagents)
6 Cabinet for liquid tanks, waste liquid tanks, solid waste and PC
7 Extensible board
8 Integrated re-suspension tool
9 Touch screen
Opening the cover during system operations may result in operation interruption and no reported results.
In case it would be necessary to open the cover, make sure to pause the pipettors (see chapter 6.2.1) and wait for 30’’
before opening the cover. This action avoids unnecessarily not reporting results.
Remove the pause condition (see chapter 6.2.1) after cover closure to allow pipettor regular operations.

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Figure 4-1: LIAISON®XL system

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4.1.3 System Modules
Figure 4-2: LIAISON®XL system modules
1 Cuvette transport (Auger)

2 Cuvette orientation mechanism (Sorter)
3 Disposable Tip Drawers
4 Loading bay for sample racks
5 Reader

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6 Loading bay for reagents and ancillaries
7 Incubator and Wash / Waste station
8 Washer
9 Pump Rack
10 Starter Reagent Pumps
11 Air pipettor with disposable tip adapter for sample pipetting (Left Arm)
12 Pipettor with steel needle for reagent pipetting (Right Arm)
4.1.4 Flaps and Drawers
Figure 4-3: LIAISON®XL flaps and drawers

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1 Left Top Cover

2 Right Top Cover
3 Touch screen
4 Reservoir for cuvettes
5 Drawers for disposable tip trays
6 Loading bay for sample racks
7 Loading bay for reagents (integrals or ancillary reagents)
8 Loading area for starter reagents
9 Extensible board

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4.1.5 Cabinet
4.1.5.1 Cabinet without drawers
Figure 4-4: LIAISON®XL cabinet without drawers

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Figure 4-5: LIAISON®XL tanks and intermediate tanks
10 Liquid waste tanks

11 Solid waste drawer (for cuvettes and disposable tips)
12 Water tank
13 Wash buffer tank
14 Cleaning solution tank
15 PC
16 Intermediate tank (Water)
17 Intermediate tank (Wash buffer)
18 Waste basin

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4.1.5.2 Cabinet with drawers
New cabinet drawers have been equipped on board of LIAISON® XL analyzers starting from August 2011.
The difference between instruments with and without drawers is the mechanical configuration of the cabinet, the
execution of assays on board of the instruments is unaltered.
Figure 4-6: LIAISON®XL cabinet with drawers

Rev. D
1 Left drawer
2 Liquid waste tank, Left
3 Liquid waste tank, Right
4 Cleaning solution tank
5 Waste basin
6 Solid waste drawer
7 Right drawer
8 Water tank
9 Intermediate tank (Water)
10 Wash buffer tank
11 Intermediate tank (Wash buffer)
12 PC
13 Cabinet doors

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4.1.6 LIAISON® XL LAS System

A modified version of the LIAISON®XL Diagnostic System, called LIAISON®XL LAS, is designed to allow compatibility with certain types of
laboratory automation systems (LAS). As can be noticed in Figure 4-7, the pipettor module is expanded, in order to allow the sample arm to
aspirate samples coming from a laboratory automation system.
LAS expansion
for left arm
Sample arm with

picked up tip
Sample tube
Laboratory
automation
system (LAS)
Figure 4-7: LIAISON®XL LAS system

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A dedicated cover (Figure 4-8 and and Figure 4-9) is mounted as a physical guard to protect the user from contact with the moving pipettor
arm.
LAS
expansion
top cover
Figure 4-8: LIAISON®XL LAS – Front view

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LAS
expansion
top cover
Figure 4-9: LIAISON®XL LAS – Lateral view

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4.1.7 Glossary
Anything that can be introduced by operator into Ancillary Area rack, including external reagents for
Ancillary (reagents)
some kits and Light Check
Barcode Reader Assembly to read the sample barcode
BGW Test to check quality of instrument washing
Control Rack 9 positions module to host some types of control bottles and external calibrators
Cuvette Single cavity plastic module, in which immunometrical reaction can take place
CV% Statistical variable that shows dispersion rate of measurements
Incubator 80 positions assembly in which cuvettes are incubated and pipetted
Part of LIAISON® XL system that contains only the LIAISON® XL analyzer and tanks, but not PC,
Instrument
printer and connection cables
Integral Reagent cartridge (made up of vials) to be inserted into the Reagent Area
Holder used for the handling of integrals outside the instrument. Up to 14 integrals can be transported
Integral Holder
together.
Set of reagents used to carry out a specific assay; it may consist of one or more integrals, external
Kit
calibrators and ancillary reagents.
LC-le Test to verify accuracy of the left dispensing pipettor, carried out by Light Check solution
LC-ri Test to verify accuracy of the right dispensing pipettor, carried out by Light Check solution
Light Check Test tool provided as lyophilised material
Light Check adaptor Plastic adaptor used to insert the Light Check bottles into the Ancillary Area rack
Reader Reading area in which chemical reaction and measurements occur
Start-up cycle for individual parts of instrument involved in fluidics, carried out by usage of DI Water,
Prime
Wash Buffer, Starter Reagents and Cleaning Solution
Pusher Exchanges cuvettes between incubator and washer or cuvette loading mechanism
Rack Holder 12 positions holder used for the handling of sample and control racks outside the instrument.

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Reagent Area Integral and ancillary loading area
RF-Tag Micro-chip present on integrals, starters and ancillaries to allow recognition and data storage
RLU Relative Light Unit (signal measurement unit)
Sample Area Loading area for samples
Sample Rack 12 positions module to host sample tubes
Anything that can be introduced by operator into Sample Area racks, including patient samples,
Samples
controls and external calibrators
Solid Waste Bin Plastic removable container to increase safety during waste bag disposal
Solid Waste Drawer Drawer of the system used to host waste bags and the solid waste bin (if equipped)
Starter (reagents) Reagents dispensed during the reading to generate chemiluminescent signal
System The complete structure installed in the laboratory
Tip Single cavity plastic probe used to aspirate samples with left pipettor arm
Tray 96 positions modules equipped in the Disposable Tip drawers to host tips
Vial Container for just one reagent; more vials form an integral
Wash Buffer Solution (to be diluted 1:10 in distilled H20) used to wash cuvettes
Wash Station Washing well for right pipettor needle
Waste Bag Container for used cuvettes and tips
Waste Basin Container used to collect spillage of contaminated liquid coming from broken waste tanks

Rev. D
4.2 Use of the Modules
In the following chapters, the individual modules and their use are explained.
4.2.1 Touch Screen and On Screen Keyboard

The integrated touch screen is needed to use the system. All inputs are made with a stylus (tip R0.8 or over) or finger directly on the touch
screen. The usage of an external keyboard or mouse is not validated therefore it is not supported.
Touch Screen Handling

 Operate with a stylus (tip R0.8 or over), or with a finger without applying excessive pressure.
 Avoid using sharp edged or hard articles.
 Avoid drawing lines along with the edge of the housing which may damage the PET/FILM and cause the failure of the touch panel due to
extreme force.
 Keep the surface clean by executing periodic maintenance (see chapter 8.9).
Improper use could damage the touch screen surface.
Use:
 Mouse emulation:
o Mouse pointer: Touch the screen with a finger or a stylus and the mouse pointer will follow the moving object.
o Single mouse click: Touch the screen once.
o Double mouse click (double click): Touch the screen twice. Do not wait between the first and the second touch.

Rev. D
 On screen keyboard (alphanumeric inputs, e.g. A - Z, 0 - 9, etc):

The LIAISON®XL software provides for input boxes an on screen keyboard to enter letters or numbers. The on screen keyboard is shown
automatically after touching an input box. A smaller version is provided for numerical input. The keyboard shows on the top left corner the
current edit field content.
Figure 4-10: On screen keyboard (alphanumerical version)
4.2.2 Barcode Reader

A handheld barcode reader (Figure 4-11.a) is supplied with the system, in order to allow the user to read bi-dimensional barcodes for control
definition.
A dedicated support (Figure 4-11.b) can be placed in the cabinet, just in front of the PC, and can be used to hold the barcode reader when it is
not in use (Figure 4-13); the support can be fixed to the system using the velcro strips (Figure 4-12) attached by the technician during the
installation.
Do not use the handheld barcode reader for purposes different from reading bi-dimensional control definitions.

Rev. D
a) Barcode reader b) Barcode reader support

Figure 4-11: Barcode reader and barcode reader support
Figure 4-12: Velcro labels for barcode reader support

Rev. D
Figure 4-13: Barcode reader position
4.2.3 Reservoir for Cuvettes

The reservoir for cuvettes allows continuous loading of the LIAISON®XL system with cuvettes. The cuvettes must be loaded in units of 200
pieces (1 bag) and remain in the reservoir until they are utilized. The management of the cuvettes in the system is performed by the
LIAISON®XL software.
The loading of the cuvettes is described in chapter 5.5.1.

Rev. D
4.2.4 Drawers for Disposable Tip trays

With two independent drawers for disposable tip trays, a continuous refilling of disposable tips and therefore an uninterrupted operation of the
system is possible.
Every drawer can be filled with up to three disposable tip trays with 96 disposable tips each. The loaded disposable tip trays are recorded by
the LIAISON®XL software (see chapter 6.10.2). An automatic consumption meter allows the exact indication of the disposable tips still present
in the instrument.
The loading of the disposable tip trays is described in chapter 5.5.2.
LEDs A LED below the relevant drawer shows the current usage status:
Description Status Action
The drawer is closed and currently being used. LED ON Do not open
the drawer.
The drawer is closed and not in use. LED OFF It is possible

to open the
drawer.
The drawer is open. LED slow It is possible
flashing to close the
drawer.
Table 4-1: LEDs on the disposable tip drawers

Rev. D
4.2.5 Loading Bay for Sample Racks

The loading bay for sample racks allows continuous loading of the LIAISON®XL system with samples. The samples in the tubes are placed in
special racks and loaded in one of the 10 lanes afterwards. As support, a LED below each lane indicates the relevant usage status (see
below).
To prevent confusion, a distinct identification number must be assigned to every sample in the LIAISON®XL software. This sample ID can be
entered either by scanning the bar-code using the barcode scanner located in the loading bay for sample racks or typing it manually.
See chapter 1-16 for Laser Safety.
To ensure the bar-code scanner can read the bar-code label correctly, the bar-code label must be of a good quality, thus meaning it shall
match Category A or B (according to ANSI X3.182 standard) or category 4 and 3 (according to ISO/IEC 15416 standard).
In addition, the following specifics shall be matched:
1) The module width (i.e. the width of the smallest bar or gap in the barcode) shall be in the range 0.167 mm ≤ width ≤ 0.5 mm.
2) For Codabar and 2/5 Interleaved typologies, the bar width ratio (i.e. the comparison in bar widths between the narrow modules and the
wide modules) shall be in the range 1:2.5 ≤ ratio ≤ 1:3 (if 0.167 mm ≤ width < 0.2 mm) or in the range 1:2 ≤ ratio ≤ 1:3 (if 0.2 mm ≤ width ≤
0.5 mm).
Regarding the positioning, the barcode must be applied to the grey section in the middle of the tube as shown in Figure 4-14.
Figure 4-14: Bar-code label on the tube

Rev. D
Length of tube: Max. length of bar-code (lbar code)

66 mm (2.60 in.) 32 mm (1.26in.)
75 mm (2.95 in.) 41 mm (1.61in.)
100 mm (3.94 in.) 66 mm (2.60in.)
Table 4-2: Length of bar-code label
Ensure that the bar-code labels face towards the left (open side of the rack) when loading otherwise they cannot be properly read.
In addition to the sample racks, racks with calibrators and controls may be loaded in the loading bay for sample racks.
The loading with racks is described in chapter 5.6.

Rev. D
LEDs A LED below each lane indicates the current usage status when the flap is open, while the status “slow flashing” is not shown with the flap
closed:
Description Status Action

The sample rack is currently being used or could be used soon for LED ON Do not remove
a test. it
Without sample rack in the lane: LED OFF Do not load a
sample rack in
 The lane is not activated, and cannot be used to load a sample this lane
rack.
With sample rack in the lane: LED OFF It is possible to
remove it.
 The samples of this rack are not used or scheduled.
The lane is activated, and can be used to load a sample rack. LED slow flashing Insert the next
sample rack
(once per second)
into this lane.
The sample rack has not been recognized. LED fast flashing Remove the
sample rack
(three times per
and insert it
second)
again.
Table 4-3: LEDs on the loading bay for sample racks

Rev. D
4.2.5.1 Sample Racks
A sample rack is a holder to store patient samples (placed in sample tubes) for use on the analyzer. The sample rack (also known as "patient
rack" or "rack") is designed to hold up to 12 sample tubes (bar-coded or non-bar-coded) and is to be inserted into the analyzer in a way such
to be registered by the analyzer and supports the sample tubes during aspiration by the sample probes.
Only the supplied LIAISON®XL approved sample racks may be used. The use of unauthorized rack types is
prohibited and may cause damage to the system.
All sample racks have the same structure as pictured and described below. The positions are numbered from 1 through up to 12 with number
1 starting farthest away from the handle.
Figure 4-15: Sample rack A

Rev. D
1 Handle
2 Sample rack identification bar-code label
3 Sample tube positions with position bar-code label and a clamp for correct position holding of sample tube
4 Clamp to lock the sample rack into the loading bay for sample racks
4.2.5.2 Control Racks
A control rack is a holder to store some types of control bottles and external calibrators for use on the analyzer. The control rack (also known
as C rack) is designed to hold up to 9 bottles (bar-coded or non-bar-coded) and is to be inserted into the analyzer in a way such to be
registered by the analyzer and supports the bottles during aspiration by the sample probes.
A set of 2 control racks is provided with each instrument.
Only the supplied LIAISON®XL control racks may be used. The use of unauthorized rack types is prohibited and may
cause damage to the system.
Control racks have the structure as pictured and described below. The positions are labeled from A through up to I with label A starting
farthest away from the handle.

Rev. D
Figure 4-16: Control Rack
1 Handle
2 Control rack identification bar-code label (%C)
3 Bottle positions with position bar-code label and position holding
4 Clamp to lock the control rack into the loading bay of the analyzer
5 Control bottles or external calibrators placed inside the rack

Rev. D
4.2.5.3 Rack Types, Tube Diameter and Dead Volume
There are 19 different types of racks (see the table below). The different types of racks refer to the inner diameter and the total height of the
sample tubes and are important for the proper management of samples. As can be noticed, together with standard rack types, 6 typologies (X,
Y, Z, D, G, H) can be directly customized by field service engineers according to user requirements.
Rack type: Internal diameter of the sample Total height of the sample Dead volume:
tubes: tubes:
Q 6 mm ≤ 55 mm 150 µL
N 7 mm ≤ 55 mm 150 µL
K 8 mm ≤ 55 mm 150 µL
J 9 mm 56 mm - 65 mm 150 µL
A 10 mm 86 mm - 100 mm 150 µL
I 11 mm 86 mm - 100 mm 200 µL
F 12 mm 86 mm - 100 mm 250 µL
E 13 mm 86 mm - 100 mm 300 µL
W 14 mm 86 mm - 100 mm 350 µL
B 15 mm 86 mm - 100 mm 400 µL
D Request Technical Assistance Request Technical Assistance Request Technical Assistance
G Request Technical Assistance Request Technical Assistance Request Technical Assistance
H Request Technical Assistance Request Technical Assistance Request Technical Assistance
X Request Technical Assistance Request Technical Assistance Request Technical Assistance
Y Request Technical Assistance Request Technical Assistance Request Technical Assistance
Z Request Technical Assistance Request Technical Assistance Request Technical Assistance

Rev. D
Rack type: Internal diameter of the sample Total height of the sample Dead volume:
tubes: tubes:
C Use only for DiaSorin special
large vials (i.e. some types of
control bottles or external
calibrators)
L Used only for DiaSorin glass vials 55 ± 0.5mm
(i.e. some types of control bottles
or external calibrators)
P Used only for pediatric tubes
Table 4-4: Rack types and sample tubes parameters
According to the above table, the size of the tubes that may be inserted in the sample racks ranges from 6 through 15 mm internal diameter.
Dead Volume The dead volume is the amount of liquid left in the sample tube that cannot be pipetted by the pipettor due to mechanical limitations and
calculations. A specific dead volume level exists for each specific tube type. When an assay is run, the user must have a minimum of the
sample amount needed to run the assay plus the dead volume amount in order to run the assay effectively.
Example:
A user wants to run 2 tests with one sample. The sample liquid is in a sample tube with 15mm diameter. According to the assay Instructions
for use, the assay requires 20µL per test. The user will have to have a total of 440µL in the tube.
Summary:
 Tubes with 15mm diameter: 400µL (dead volume)
 2 tests with 20µL: 40µL (usable sample volume)
 Total volume needed: 440µL
In the case of plasma gel separator containers, the amount of sample should be at least 500µL plus the volume
required to run the test.

Rev. D
Insufficient or Missing Patient Sample Liquid
Insufficient or missing patient sample liquid might create erroneous sample aspirations. Therefore, a warning
message will be given together with an audible signal. The test must be repeated after a sufficient level of sample
has been inserted.

Rev. D
4.2.6 Loading Bay for Reagents (Integrals and Ancillary Reagents)
Figure 4-17: Front view of the loading bay for reagents
1 Lane for ancillary reagents and additional reagents

2 25 lanes for integrals
3 LEDs for each lane
4 Flap

Rev. D
The loading bay for reagents allows a continuous loading of the LIAISON®XL system with reagents in the form of integrals or ancillary
reagents. As a guide, a LED below each lane indicates the relevant usage status (see below).
Integrals:
 Up to 25 integrals can be used at the same time.
 Integrals can be loaded directly into one of the 25 lanes according to the specifications of the LIAISON®XL.
 For the front position of the integral, a stirrer drive is provided. With the stirrer drive, magnetic particles can be evenly distributed in the
reagent.
Ancillary reagents:
 Up to 4 ancillary reagents or reagents can be used at the same time.
 Ancillary reagents must be placed in an ancillary rack with adapters before usage. Then, the ancillary rack can be loaded in the special
lane (on the very left) according to the specifications of the LIAISON®XL software.
Before using integrals or ancillary reagents, read the IFU (instructions for use) provided in the reagent package
(storage, preparation)!
Observe instructions for a correct re-suspension of magnetic particles.
Always use an ancillary rack in combination with the system it has been provided with.
The information included in the integral or ancillary reagent (RFID label) is read and used in the LIAISON®XL software.
The loading bay for reagents is cooled during the complete operation (incl. stand-by mode). The liquid inside the integrals and ancillary
reagents are cooled to 13°C +/- 2°C.

Rev. D
To avoid temperature errors of the reagent loading bay, it should be opened only briefly for loading and unloading.
The system will beep to remind to close the reagent bay flap.
A LED below each lane indicates the current usage status when the flap is open, while the status “slow flashing” is not shown with the flap
closed:
LEDs Description Status Action
The integral or ancillary reagents are currently being used or LED ON Do not remove it.
scheduled for a test.
The integral or Ancillary reagents are not used or scheduled. LED OFF It is possible to
remove it.
The lane is activated, and can be used to load an integral or the LED slow flashing It is possible to
ancillary rack. insert an integral
(once per second)
or the ancillary
rack into this lane.
The integral or ancillary reagents have not been recognized. LED fast flashing Remove the
integral and insert
(three times per
it again.
second)
Table 4-5: LEDs on the loading bay for reagents
4.2.6.1 External Reagents
DiaSorin external reagents are delivered in vials separated from the integral, for example lyophilized kit reagents, or Light Check for
troubleshooting.
These vials are of appropriate dimensions made to fit dedicated adaptors for the ancillary rack. This is the only rack type to be used for these
vials.
External kit reagents, that shall be used as part of a test routine, are provided mounted on a specific non removable adaptor. Reagents like
Light Check, that are not to be used as part of a regular test routine, are to be inserted into adaptors provided with the instrument.

Rev. D
®
The information included in the reagent (RFID label) is read from the system and used in the LIAISON XL software.
4.2.7 Integrated re-suspension tool

The integrated re-suspension tool is a solid state magnetic device which aids in the dispersal of microparticles prior to placement of a
LIAISON®XL reagent integral on the LIAISON®XL system.
For a LIAISON®XL reagent integral to perform as intended, the microparticles must be completely and homogeneously re-suspended. The
integrated tool is designed to assist in the preparation of the reagent integral by magnetically drawing the paramagnetic microparticles away
from the bottom of the reagent integral microparticle vial. With subsequent agitation of the vial automatically performed by the instrument over
a 15 minutes time span, the operator is ensured of a properly prepared reagent integral.
4.2.7.1 Use of the integrated re-suspension tool
1. Slide the reagent integral into the slot until it is fully engaged;
2. Allow the reagent integral to remain in the tool for at least 30 seconds;
3. Remove the integral and inspect for the presence of particles at the bottom of the vial: if microparticles are still present at the bottom,
repeat procedure as many times as needed to have a complete removal;
4. After a complete removal of particles from the bottom of the vial has been achieved, insert the integral in an available slot in the
reagent area and let it agitate for 15 minutes before starting a run.

Rev. D
4.2.8 Area for Starter Reagents

The area for starter reagents contains the starter reagents (LIAISON®XL Starter Kit). The starter reagent bottles are provided with removable
screw caps that are to be removed to allow the insertion of the dedicated tubing. Correct emplacement is ensured by a clamp holding on a
reset on the bottle neck. A RFID in the back of the bottle identifies starter reagents and tracks consumption. Since the starter reagents are
light sensitive, the flap of the area must always be closed.
To prevent confusion, the information included in the starter reagent (RFID label) is read from the system and used in the LIAISON®XL
software.
To allow continuous exchange, each position contains one LED which indicates the relevant usage status (see below).
Please read the instructions for use (IFU) concerning the starter reagents (LIAISON®XL Starter Kit).
Always keep the starter reagent area closed to avoid light.
An LED indicates for each position the current usage status when the flap is open, while the status “slow flashing” is not shown with the flap
closed :

Rev. D
LEDs Description Status Action
The starter reagent is currently ready to be used for a test. LED ON Do not remove it.
The loaded starter reagent is not used or scheduled. LED OFF It is possible to remove
it.
The lane is activated, and can be used to load a starter bottle. LED slow flashing Insert a starter reagent
(once per second) at this position.
The starter reagent has not been recognized or it is the wrong LED fast flashing Remove the starter
type. reagent completely and
(three times per
insert it again.
second)
Table 4-6: LEDs on the area for starter reagents

Rev. D
4.2.9 Cabinet
All large-volume containers for the liquid supply and disposal are located in the cabinet. In addition, there is a container with a foil bag for the
solid waste and a bottle for routine cleaning of the system lines. Some additional devices (waste basin, waste bin) are used to increase safety
in the handling of contaminated materials.
4.2.9.1 Water
The water container together with a docking container allows the refilling of water without interruption of the operation of the LIAISON®XL. A
sensor hereby controls the current liquid level and requests the user to refill water at a certain residual volume. For refilling, the user removes
the water container (10 L) and returns it to its original position after refilling. A corresponding docking connector provides the leak proof
connection between the two containers.
4.2.9.2 Wash buffer
The wash buffer container together with a docking container allows the refilling of wash buffer without interruption of the operation of the
LIAISON®XL. A sensor hereby controls the current liquid level and requests the user to refill wash buffer at a certain residual volume. For
refilling, the user removes the wash buffer container (10 L) and returns it to its original position after refilling. A corresponding docking
connector provides the leak proof connection between the two containers.
4.2.9.3 Cleaning solution
The cleaning solution container has a volume of 2 liters. Level in bottle is not tracked by the system. The user must ensure that enough liquid
is present for required task before starting a maintenance routine.
4.2.9.4 Liquid waste
See Biological safety in chapter 1.8.6.

Rev. D
®
To allow a continuous operation of the LIAISON XL, the system is provided with two independent liquid waste containers (2x10 L). As soon
as one of the two containers is full, the system automatically switches to the second container and the user is requested to empty the relevant
container. At the container itself, there is an LED indicating the usage status (see below).
LEDs LED Status Description Action

ON The container is currently being used or Do not remove it.
scheduled for a test.
OFF The container is not used or scheduled. It is possible to remove it.
Table 4-7: LEDs on the waste containers
4.2.9.5 Waste basin
A waste basin is placed in the cabinet of the instrument to host waste tanks. This solution is used to avoid a potential contamination of the
cabinet caused by spillage of contaminated liquid from a broken waste tank. Different versions of the waste basin are installed on instruments
with or without cabinet drawers.
Refer to chapter 1.10.7 for labelling and chapter 5.5.6.3 for removal procedures.
4.2.9.6 Direct drain configuration
LIAISON®XL system supports also a direct drain configuration, where a waste tube can be directly connected to the system allowing to
dispose liquid waste directly into a collector drain. In this case liquid waste containers and basin shall not be installed in the instrument.
Direct drain is an optional solution, all systems are shipped with waste containers. In case of specific request of the users, direct drain
configuration can be implemented by field service engineers during the installation of the instrument or at a later point in time.

Rev. D
Tubing from
the
instrument
Drill hole in the

separation sheet
Hole in the
metal, position of
tube fitting with Cabinet Floor:
strain relief tube goes From the
through and out separation panel
of the system. onwards, the
tubing is covered
by a protection
conduit.
Figure 4-18: Direct drain connection, back view
Direcr Drain Installation

Please note that the direct drain configuration may only be installed by authorized service personnel.

Rev. D
The maximum height of the waste tubing must not exceed 90 cm above floor, with the outlet of the tubing on 80 cm.
The tubing has a length of 3 m outside the cabinet.
4.2.9.7 Solid waste drawer
Next to the liquid waste containers, there is a drawer for solid waste (cuvettes and disposable tips) accumulated in the LIAISON®XL system.
To simplify disposal, and contain biological hazards, the container is provided with a foil bag.
To allow continuous operation during the exchange of the foil bag, the system is provided with an additional container. In this additional
container, the accumulating solid waste is collected during the replacement of the foil bag and put into the solid waste drawer automatically
upon reclosing the solid waste drawer. The filling level of both containers is controlled by the LIAISON®XL software.
4.2.9.8 Solid waste bin
In order to increase the safety during waste bag disposal, a solid waste bin can be placed in the dedicated drawer of the cabinet, in order to
host the waste bag. The available handles allow the user to remove and reinsert it into the waste drawer, thus avoiding any contact with the
bag during the disposal phase.
Refer to chapter 1.10.6 for labelling and chapter 5.5.7.2 for use.

Rev. D
4.2.10 Incubator
In addition to heating, the incubator includes a conveyor belt for the transport of up to 80 cuvettes. The conveyor belt moves every single
cuvette to various positions (washer or pipetting positions) when needed.
The working temperature range (36.5 °C – 38.5 °C) is reached at the latest after a heating time of 1 hour. If the temperature falls below or
exceeds the expected range value during operation, a warning is issued.
The current temperature of the incubator can be found in the LIAISON®XL software in the main category Status sub category Temperatures
(see chapter 6.10.3).
4.2.11 Pipettors
The LIAISON®XL system is provided with two independent pipettors to distribute samples and reagents throughout the testing processes. The
two pipettors can aspirate variable liquid volumes of samples or reagents and dispense them into the cuvettes in the incubator.
Sample Pipettor A pipettor working with disposable tips aspirates liquid from a specified sample, control or external calibrator and dispenses it into a cuvette.
The LIAISON®XL software associates the dispensed sample and the test to be processed to the cuvette.
This pipettor, located on the left side of the system, can only reach the loading bay for samples during a test routine, and additionally the
ancillary area in the loading bay for reagents during a maintenance routine.
Additionally, the sample pipettor allows the transferal of liquid from one cuvette to another in order to perform sample pre-dilutions.The use of
disposable tips prevents cross-contamination between samples, controls or external calibrators.
Reagent Pipettor A stainless steel probe pipettor aspirates liquid from one or more reagent vials (integral or ancillary reagent) and dispenses it into a cuvette.
The inside and outside of the steel probe is cleaned in the wash station after the process step, in such a way as to prevent cross-
contamination between different reagents..
Checks To ensure the correct take-up of liquid, both pipettors are provided with a liquid level detection system and volume aspiration and dispensing
monitoring. The combination of the two allows for the aspiration of liquid(s) from the appropriate position and for the control of the accuracy of
the dispensation. Additionally, the left pipettor can detect whether there are clots in a sample.

Rev. D
4.2.12 Washer
In the washer, several cuvettes can be processed at the same time. Cuvettes in the washer can be transported either back to the incubator or
into the reader after processing, according to the sequence of the requested assay. The washer needles are rinsed after every aspiration
cycle.
4.2.13 Reader
The dispensing of the two starter reagents and the chemiluminescence measurement are carried out in the reader, equipped with a high
sensitivity photomultiplier. The reader is sealed from all outside light influences. The two independently controlled injection pumps for injection
of the starter reagents are placed outside the reader: each of them operates with a constant volume of 200 µL to inject starter reagents into
the cuvette. One injection of each of the two starter reagents (starter 1 and starter 2) is needed in order to develop the chemiluminescent
reaction.
The geometrical arrangement of the injectors in the Reader ensures that the injection of starter 1 is directed against the wall of the cuvette.
Starter 2 is injected straight into the cuvette. This ensures optimum re-suspension of the magnetic particles. After each individual
measurement and before cuvette disposing, the reaction solution is drawn from the cuvette by an aspiration needle. Once completed this
operation, the cuvette is then disposed off into the waste bag.
4.2.14 Visual Alarm

On top of the LIAISON®XL system a visual alarm system may be installed as an option.
The visual alarm system shall provide the user with visual warnings of the system functionality over short distances. It shows a visual signal
about fatal and system errors.
The mute and auto-mute functionality for the beeper also turn off the visual alarm.
4.2.15 Printer
An USB printer can be connected to the Analyzer by authorized DiaSorin service personnel; a dedicated support can be added to the right
side of the instrument, in order to allow a proper placing of the printer. Both local and network printers are supported; the printer connected to
the Analyzer shall be set as “default printer”.
Print only hard copies. Never change the destination printer.

Rev. D
4.2.16 Holders
4.2.16.1 Rack Holder
A dedicated holder (Figure 4-19) is available for handling of sample and control racks outside the instrument. Up to 12 racks can be
transported at the same time using this holder.
Figure 4-19: Rack holder with equipped racks
4.2.16.2 Integral Holder
A dedicated holder is available for handling of reagent kits outside the instrument. Up to 16 kits can be transported at the same time using this
holder; dedicated positions are available to host kits composed by 2 integrals.

Rev. D
4.3 Accessories and Consumables
In order to facilitate tests requested by the user, the instrument requires the following:
Cuvettes – Vessels in which the immuno-chemical reaction between the sample and reagents occurs. The measurement of the immuno-
chemical reaction is also achieved in these vessels.
Disposable Tips – The vessels used to transport sample from the laboratory container to the cuvette.
Samples – Liquids obtained from patients in the form of blood, serum, plasma, or urine necessary for determining the results of a certain test
for a certain patient.
Reagents – Groups of biological or chemical agents scientifically combined to assess a certain status of a sickness or disease of a given
patient.
These above listed items must be added by the user as pertaining to the respective tests and the amount of tests wanted.
Use only the consumables and accessories described herein and approved by DiaSorin S.p.A.
The Instructions for use for accessories and of consumables are provided for user safety and give important
instructions for the handling. The IFU for the consumables can be found in the appendix of this manual.
See chapter 5.5 and chapter 5.7 for the use of accessories and consumables.

Rev. D
5 Use of the System
5 Use of the System

Conditioning time
The system requires 1 hour for temperature conditioning of the incubator and the reagent loading bay.
In this chapter, the processing of a test from switching on the system to switching off the system for a "normal" user is described in regards to
starting a worklist.
All functions of the LIAISON®XL software are described in chapter 6.
5.1 Safety and Hints
See chapter 1.8 for all safety hazards.

Rev. D
5 Use of the System
5.2 Typographical Conventions
Software
Figure 5-1: Screen
1 Main categories:
Click on the respective tab to change the main category.
Example: Click on the System main category tab.

Rev. D
5 Use of the System
2 Sub categories:
Click on the respective tab to show details of the sub category in the sub category display.
Example: Click on the Settings sub category tab.
3 Display:
Shows all details of the selected sub category.
Example: The system shows all functions on the Settings sub category display.
4 Header:
Shows information about the system and contains the Stop, Start and Support buttons.
Example: The system status is shown on the Header.
5 Tabs:
Subdivides a sub category into different areas.
Example: Click on the Others tab.
6 Groups:
Combines functions to groups.
Example: All functions are shown in the Language group.
7 Buttons:
Click on the respective button to start a special function.
Example: Click on the Apply button.
8 Selection boxes:
Click on the arrow and select one of the shown entries.
Example: Select the YYYY-MM-DD entry of the DateFormat selection box.

Rev. D
5 Use of the System
9 Checkboxes:
Click on the square or circle box to activate a function or option.
A checkmark in a square box of a checkbox shows an activated function/option.
A point in a radio button shows an activated function/option. These types of radio buttons are organized in
groups. Only one radio button for each group can be activated.
Example: Activate the Auto log-off checkbox.
10 Input boxes:
Use the on screen keyboard to write into an input box. See also section Tooltips below.
Example: Enter the new value in the Minutes box.
- Tooltips:
Tooltips are used to inform the user about wrong values in input boxes. After entering the correct value, the
tooltips disappear. The tooltips disappear also automatically few seconds after their appearance.
Miscellaneous LEDs and signal Describes LEDs (light emitting diode) and signal lamps of the instrument.
lamps
Example: The Lane LED of the sample loading bay will illuminate.
Keys Describes special keys of the on screen keyboard.
Example: Press on the Enter key to confirm the entry.
Drives, folders, Describes special drives (hard disks, USB sticks) of the computer or special folders and files on the
and files computer.
Example: Choose D:\LiaisonXL\Share as backup path.
Prescribed Describes special parameters or values to enter into an input box.
parameters
Example: Enter 10 into the shown input box.

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5.3 Daily activities plan
Start-up  Switch-on (only if off) chapter 5.4

 Log-on
 Respect the conditioning time
Check  Check cuvettes, disposable tips, starter reagents and chapter 5.5
liquid containers
Load Integrals and  Load integrals chapter 5.7
Ancillary reagents
 Load ancillary reagents
Load Controls and  Load controls chapter 5.7
Calibrators
 Load calibrators
Calibrate integrals  Calibrate integrals chapter 5.7
Load Samples and Assign  Load patient samples chapter 5.6
Assays
 Assign assays to the patient samples
Start Worklist  Start the run chapter 5.8
Results  Check results chapter 5.9
Errors and Events  Check errors and events chapter 5.9.5
Unloading  Unload unused sample racks chapter 5.11
 Unload unused integrals
Shut Down/End of Day  No special care chapters 5.12 and 6.9
Maintenance
 If planned for today, perform periodical maintenance

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5.4 Start-up
Procedure Switch on and log-on:

1. Ensure that the cover and the flaps are closed.
2. Switch on the instrument.
3. Switch on the integrated PC.
The system starts the operating system and the LIAISON®XL software on the integrated PC.
4. After system start, the LIAISON®XL software shows the Startup display:
Figure 5-2: Startup screen

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Function Description
Backup Starts the external backup viewer application (see chapter 6.11).
LiaisonXL Starts the LIAISON®XL software (see below).
Monitor Shows the touch screen control panel, to calibrate manually the touch screen monitor.
QC Starts the long term quality control (QC) application (see chapter 7).
Shutdown Shut the PC system software and switch off the computer.
Virus Scan Starts the virus scan software. In case a virus is reported, please contact local support.
Table 5-1: Functions of the Applications sub category
5. Click on the LiaisonXL button.

The LIAISON®XL software shows the Login display:
Figure 5-3: Login

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There are several security levels of user access rights on the LIAISON®XL system. Some system functions are only
available for users with an appropriate access level (e.g. changing system options, or setting user accounts).
The system may spontaneously require to perform an automated back-up of temporary files upon pressing the
LiaisonXL button. This action will take few minutes, and will improve the PC performance. Please confirm the related
pop-up when prompted.
6. Enter the user name into the User box.

The user name is not case sensitive.
7. Enter the appropriate password into the Password box.
The password is case sensitive.
8. Click on the Login button.
9. From the STOP menu, initialize the system (see chapter 6.2.1).
The LIAISON®XL software initializes the instrument and shows the Loading Samples display.
Conditioning time:
10. Wait for 1 hour. The system requires 1 hour for temperature conditioning of the incubator and the reagent loading bay.

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5.5 Check Cuvettes, Disposable Tips, Starter Reagents and Liquid Containers
At the beginning of each run, the filling level of the liquid containers and the starter reagents must be checked, as well as sufficient cuvettes
and disposable tips available in the instrument.
Procedure 1. Click on the Status main category tab.

2. Click on the Summary sub category tab.
Figure 5-4: Sub category Summary

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It is possible to compare the indicated conditions with the actual filling levels in the relevant containers, bottles and
solid waste. If the indicated and actual filling levels are not concordant with each other, a service engineer should be
contacted if required.
Other possible Additional

(blue) (yellow) (red) status information
Water at least 30% in range 13%-30% running out (less than Disconnected "Active" tests are not
13%) counted.
Wash Buffer at least 30% in range 12%-30% running out (less than Disconnected "Active" tests are not
12%) counted.
Starter at least 80 injections less than 80 running out (0,1,2 Absent (bottle not Thresholds are
injections injections) loaded) compared with the
difference between
Present (bottle not
number of available
primed)
shots and "active"
Not Available (bottle tests. Red is reached
empty or offline) when this difference
is 0.
Cuvettes cuvettes are detected cuvette buffer is running out (less than Based on sensors
by sensors empty 3 cuvettes detected) detection

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Solid Waste no more than 1700 in range 1700-2000 nearly full (more than Pulled Out "Active" tests are not
2000) counted for yellow
(cuvettes/tips)
status.
Red threshold is
compared with the
sum of number of
cuvettes (tips) in
waste drawer and
"active" tests.
When pulled out,
there is space for no
more than 50.
Liquid Waste no more than 70% in range 70-84% nearly full (more than Absent (tank not Thresholds are
84% liquid) loaded) referred to the total
amount of the two
tanks.
"Active" tests are not
counted.
Table 5-2: Used colour code
Symbol Meaning
Container connected and active
Container connected and inactive
Container not connected
Table 5-3: Used symbols

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System Fluids Shows the usable volume of the Water and the Wash Solution containers [in percent].
Group Notice the System Fluids group:
3. Check the levels of both system fluids containers (Water and Wash Solution). If low, refill them.
Cuvettes Group Function Description

Added Bag Press on this button after refilling of cuvettes. The Cuvettes
counter incremented about 200.
(1 cuvettes bag = 200 cuvettes)
Cuvettes Shows the number of cuvettes in the instrument.
Reset Press on this button to set the Cuvettes counter to 0.
Table 5-4: Functions of the Cuvettes group
Notice the Cuvettes group:

4. Check the number of the cuvettes. If low, refill them.
Refill procedure: see chapter 5.5.1
Tips Group Shows the number of unused disposable tips in the instrument.
Notice the Tips group:
5. Check the number of the disposable tips in both drawers. If low, refill them.
Refill procedure, see chapter 5.5.2.

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Waste Group Shows the filling level of the liquid waste containers (Tank 1 and Tank2) in per cent, and Solid waste (cuvettes and disposable tips).
Reset Pressing on this button clears the counter for solid waste. The
procedure is due upon empting of the solid waste reservoir
Changes the used waste tank:
 Tank 1 > Tank2: Changes tank in use: from Tank 1 to
or
Tank 2
 Tank 1 < Tank2: Changes tank in use: from Tank 2 to
Tank 1
Table 5-5: Functions of the Waste group
See chapter 1.8.6 for Biological Safety.
Notice the Waste group:

6. Check the levels of both waste liquid containers (Tank 1 and Tank2). If full or nearly full, empty and decontaminate it.
7. Check the level of the Solid waste container. If full or nearly full, empty it. After that, click on the Reset button.
Shows remaining injection counters of all loaded starter reagents. The counter decreases after every injection.
Starter Reagents
Group
Notice the Starter Reagents group:
8. Check the levels of the starter reagent bottles. If low, load a new bottle.
The information is reported only when the starters after correctly primed by the system.

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5.5.1 Refill cuvettes
Before starting the handling procedure, consult Instruction for Use (IFU) for cuvettes.
Procedure 1. Holding the cuvette pack so that the perforated end is upright, ensure that all cuvettes in the bag are below the perforated mark.
2. Using one hand to hold the pack under the perforated mark, remove the upper end of the cuvette pack (Figure 5-5) and immediately
discard the separated piece.
Figure 5-5: Opening the cuvette pack
3. Open the cuvette loading access door on the analyzer.

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4. Continuing to hold the cuvette pack in an upright position, place the cuvette pack directly over the cuvette loading access and slowly
empty the complete contents of the cuvette pack into the loading access (Figure 5-6)
Figure 5-6: Loading the cuvette pack
5. Once the loading has been completed, close the cuvette loading access door and discard the cuvette pack.
6. Select the sub-category Summary of the category Status (refer to chapter 6.10.1). Press Added bag button corresponding to the number
of packs loaded.

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Always load the complete cuvette bag into the analyzer.
Press the button only once for each bag loaded.
Cuvettes are for single use only.
During the loading of cuvettes, verify not to exceed the maximum tolerated level, indicated by the red line available
on the cuvette reservoir (see chapter 1.10.16).

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5.5.2 Refill Disposable Tips
Before starting the handling procedure, consult Instruction fo Use (IFU) for tips.
Procedure 1. Click on the Status main category tab.

2. Click on the Disposable Tips sub category tab.
Figure 5-7: Sub category Disposable Tips

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Assign Gives the access of the drawer to the pipettor system. The
LED below the drawer on the system and the indicator above
the drawer in the software display change to yellow.
The Assign button is only available when the drawer is
closed.
Delete All Deletes all disposable tips on the single disposable tip tray.
Set All Fills the single disposable tip tray with disposable tips.
Withdraw Gives the access of the drawer to the user. The LED below
the drawer on the system and the indicator above the drawer
in the software display change to grey.
Note: If the instrument is pipetting, the pipettor will use the
other drawer. If the LED does not turn grey, the drawer cannot
be released by the system. If the drawer contains no tips, the
drawer is automatically withdrawn.
Standard buttons For standard buttons (e.g. arrow buttons, lock, Print) see
chapter 6.1.
Table 5-6: Functions of the Disposable Tips sub category
3. Click on the disposable tip tray position of drawer 1 or 2.

4. Click on the Withdraw button.
The LED below the drawer on the system is flashing off and the indicator above the drawer on the software display changes to grey.
If the system is pipetting, the pipettor will use the other drawer. If the LED does not turn grey, the drawer cannot be
released by the system. If the drawer contains no tips, the drawer is automatically withdrawn.
5. Open one of the tray access flaps on the disposable tip user box.

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Figure 5-8: Disposable tip user box
The LIAISON®XL disposable tip user box may be opened from either the top or bottom of the box. Each opening
gives the user access to 3 trays. Only one of the openings can be opened at a time.
6. Pull out the selected drawer.

7. If present, remove the empty disposable tip tray(s).
8. Using one hand, take one of the disposable tip trays by holding it on the longer side and insert it into the disposable tip drawer on the
analyzer.
9. If necessary, repeat point 8 until all positions of the drawer have been loaded.
Insertion of partially filled tip trays is possible; in this case, it is necessary to pay attention to the tip placement and to
indicate their placement on the software interface in next steps.

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Figure 5-9: Loading the tip tray
10. Close the opened drawer.

Note: this step may be performed even afterwards, before pressing the Assign button.
11. Click on the Set All button.
12. If more than one tray has been loaded in the selected drawer, click on the next refilled disposable tip tray position of the selected drawer
and click on the Set All button, too.
13. When ready, click on the Assign button.
The LED below the drawer is permanently illuminated and the indicator above the drawer on the display changes to yellow. The pipettor
has access to the drawer. From now on, to remove the drawer it is necessary to repeat this procedure from step 1, regardless if the
system is running or not.
All disposable tips are for single use only.

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5.5.3 Load and Unload Starter
The starter reagents also include 4% sodium hydroxide and a 0.12% peroxide solution. If splashes of the NaOH
solution or the alkaline peroxide solution get into eye, immediate and thorough washing with water or a suitable buffer
solution is recommended. If necessary, a physician should be consulted.
Starter pooling is prohibited!
Refer to the safety notes (see chapter 5.7)!
The LIAISON®XL Starter Kit should be kept away from direct sunlight.
Please comply with the storage and shelf life information for the starter reagents (LIAISON®XL Starter Kit).
Unload 1. Open the flap for starter reagents.

Procedure 2. The LED below the empty starter reagent bottle must be off.
If the LED is slow flashing, there is no starter reagent bottle.
Remove the cap of the empty starter reagent bottle.
3. Remove the empty starter reagent bottle.

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Load Procedure 1. Remove the locking cap of the new starter reagent bottle.
2. Place the LIAISON®XL system cap onto the new starter reagent bottle.
It is essential to ensure correct connection to starter 1 and starter 2.
3. Insert the new starter reagent bottle into the LIAISON®XL system.
4. If the LED below starts flashing fast (three times per second), the starter reagent bottle has not been recognized or it is the wrong starter
type.
5. If point 4 has been verified, remove the starter reagent bottle completely and re-insert it.
6. Close the flap for starter reagents.
The LIAISON®XL system will prime the new starter reagents automatically when possible.
In case lot numbers change, it is necessary to recalibrate all integrals. The system will disable all existing
calibrations.
Loading starter bottles in all corresponding positions at the same time helps to minimize the amount of starter shots
used for prime reasons.
The system automatically primes the starter bottles, either upon loading or whenever possible. This may lead to
delayed results or tests not starting. To ensure that test results will occur according to the expected timelines, check
when the related tests are scheduled and expected.

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5.5.4 Load and Unload the Water Tank
5.5.4.1 Instruments without cabinet drawers
Unload Procedure 1. Open the cabinet (see chapter 4.1.5).

2. Raise the front of the (empty) water container approximately 2cm (0.8inch).
3. Pull the water container out of the LIAISON®XL system.
Load Procedure 1. Place the full water container into the LIAISON®XL system.
Note the audible click.
The centering pin must fit into the intermediate container (Figure 5-12.b).
2. Close the cabinet.
5.5.4.2 Instruments with cabinet drawers
Unload Procedure 1. Open the cabinet doors.

2. Pull the right drawer out of the cabinet (Figure 5-10).

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Figure 5-10: Right drawer pulled out
3. Raise the front of the (empty) water tank approximately 2cm (0.8inch) (Figure 5-11).

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Figure 5-11: Raise water tank
4. Pull the water tank out of the LIAISON®XL system.

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Load Procedure 1. Holding the drawer by hand (Figure 5-12.Errore. L'origine riferimento non è stata trovata.a), place the full water tank into the the right
cabinet drawer of LIAISON®XL system.
The centering pin must fit the intermediate tank (Figure 5-12.Errore. L'origine riferimento non è stata trovata.b).
a) b)
Figure 5-12: Water tank insertion and fitting

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2. Push the right drawer back into the cabinet (Figure 5-13).
Figure 5-13: Right drawer insertion
3. Close the cabinet doors.

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5.5.5 Load and Unload the Wash Buffer Tank
5.5.5.1 Preparation
1. See instruction for use.
Before the wash buffer is handled or loaded into the LIAISON®XL system, the package information is to be read
thoroughly and followed by the user. Use the red line available on the tank as an aid during the preparation of the
wash solution (refer to chapter 1.10.9).
LIAISON®XL wash buffer must fulfill the requested ambient operating conditions during installation and should never
be used after defined expiration date for onboard stability.
After completion of the wash buffer preparation, the cap must be placed lightly on the container to allow proper
degassing of the wash buffer solution!
Freshly prepared or non-degassed wash buffer should not be used in the LIAISON®XL system.
The LIAISON®XL wash buffer container should be kept away from direct sunlight.

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Unload 1. Open the cabinet (see chapter 4.1.5).

Procedure 2. Raise the front of the (empty) wash buffer tank approximately 2cm (0.8inch).
3. Pull the wash buffer tank out of the LIAISON®XL system.
Load Procedure 1. Place the full wash buffer tank into the LIAISON®XL system.
The centering pin must fit into the intermediate tank (Figure 5-12.b).
Unload 1. Open the cabinet doors.

Procedure 2. Pull the right drawer out of the cabinet (Figure 5-10).
3. Raise the front of the (empty) wash buffer tank approximately 2cm (0.8inch) (Figure 5-14).

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5 Use of the System
Figure 5-14: Raise wash buffer tank
4. Pull the wash buffer tank out of the LIAISON®XL system.

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5 Use of the System
Load Procedure 1. Holding the drawer by hand (Figure 5-15), place the full wash buffer tank into the the right cabinet drawer of LIAISON®XL system.
The centering pin must fit into the intermediate tank (Figure 5-12b).
2. Push the right drawer back into the cabinet (Figure 5-13).
Figure 5-15: Wash buffer tank insertion

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5.5.6 Load and Unload the Liquid Waste Containers
Note the control light on the connector and remove only unused liquid waste containers (the control light is off). It is
possible to change the liquid waste container currently in use through the dedicated button, see chapter 6.10.1.
Unload 5.5.6.1 Instruments without cabinet drawers

Procedure
1. Open the cabinet (see chapter 4.1.5).
2. Pull the full liquid waste tank partially out of the LIAISON®XL system.
3. Raise the sensor connector locking device to open it.
4. Disconnect the sensor connector.
5. Press the connector release button while raising the liquid tube to release the contact of the connector.
6. Disconnect the liquid connector. Use a vessel and paper towels to avoid liquid spills.
7. Completely remove the waste tank.
8. Empty the waste tank and preferably add 200 mL of commercial hypochlorite or bleach.
Load Procedure 1. Connect the liquid connector.

2. Attach the tube of the liquid connector until an audible click is heard.
3. Connect the sensor connector.
4. Turn the sensor connector until the male & female grooves are aligned and press the sensor connector down until an audible click is
heard.

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®
5. Place the liquid waste tank into the LIAISON XL system.

Procedure 2. Pull the left cabinet drawer out (Figure 5-16).
Figure 5-16: Left drawer pulled out

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3. Raise the sensor connector locking device to open it.

4. Disconnect the sensor connector (Figure 5-17).
Figure 5-17: Waste sensor disconnection
5. Press the connector release button while raising the liquid tube to release the contact of the connector.
6. Disconnect the liquid connector (Figure 5-18). Use a vessel and paper towels to avoid liquid spills.

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Figure 5-18: Liquid connector disconnection
7. Put the liquid and the sensor connectors into the dedicated slot of the basin (Figure 5-19), in order to avoid liquid spills into the cabinet.

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Figure 5-19: Slot for disconnected waste tube and sensor
8. Completely remove the waste tank (Figure 5-20) from the basin.

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Figure 5-20: Waste tank removal
9. Empty the waste tank and preferably add 200 mL of commercial hypochlorite or bleach.

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Load Procedure 1. Put the waste tank back into the waste basin of the left drawer.
2. Connect the liquid connector.
3. Attach the tube of the liquid connector until an audible click is heard.
4. Connect the sensor connector.
5. Turn the sensor connector until the male & female grooves are aligned and press the sensor connector down until an audible click is
heard.
6. Push the left cabinet drawer in (Figure 5-21).
Figure 5-21: Left drawer pushed in

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5.5.6.3 Joint connector for waste
A joint connector may be installed in some instrument configurations in place of the separate sensor and liquid connector described in chapter
5.5.6.1 and 5.5.6.2. The joint connector is used to manage the insertion/ removal of the waste sensor and tubing as a single task. A
membrane element avoids splashing of liquid when the liquid connector is removed.
During the unload phase (Figure 5-22) the removal of the sensor connector also implies a removal of the liquid tubing from the dedicated
membrane; as a safety requirement, the sensor is completely disconnected before the liquid tubing is pulled completely out of the membrane.
Figure 5-22: When disconnecting the sensor, the tubing is also pulled out of the membrane

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During the load phase (Figure 5-23) the insertion of the liquid tubing into the membrane also implies the connection of the sensor; as a safety
requirement, the tubing is pushed into the membrane before the sensor is completely connected (i.e. an audible click is heard when
connection is performed).
Figure 5-23: When pushing the tubing into the membrane, the sensor is also connected

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5.5.6.4 Waste basin handling
If spillage from waste tanks occurs, liquid will be collected in the waste basin, thus preventing the cabinet area from contamination.
In case of the presence of liquid inside the waste basin, raise it up from the drawer (Figure 5-24), empty it and perform its decontamination
according to what indicated in chapter 1.8.6 and 1.8.8.
The same procedure shall be applied to handle the basin equipped on instruments without cabinet drawers.
Figure 5-24: Waste basin removal

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5.5.7 Load and Unload the Solid Waste Bag
The LIAISON®XL system does not monitor the presence of the Solid Waste Bag, therefore the user shall ensure that
it is loaded before starting a run.
5.5.7.1 Procedures without solid waste bin equipped

Unload
Procedure 1. Open the cabinet (see chapter 4.1.5) and pull the solid waste drawer out of the LIAISON®XL system (Figure 5-25).
Figure 5-25: Pull solid waste drawer out

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2. Unhook the solid waste bag from the tensioner in the back of the drawer (Figure 5-26).
Figure 5-26: Unhook the bag from the back tensioner
3. Unhook the solid waste bag from the front of the drawer (Figure 5-27).
4. Remove the solid waste bag from the drawer.
5. Close the solid waste bag with the dedicated strap (Figure 5-28) and then dispose of it.

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Figure 5-27: Unhook the bag from the front of the drawer
Figure 5-28: Close the bag with the strap

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Load Procedure 1. Place a new solid waste bag into the solid waste drawer.
2. Hook the solid waste bag to the tensioner (Figure 5-29) available in the back of the solid waste drawer (Figure 5-30).
Figure 5-29: Bag tensioner
3. Hook the solid waste bag to the front of the drawer (Figure 5-31).
4. Adjust the positioning of the bag inside the drawer (Figure 5-32), in order to guarantee the availability of the whole volume.
5. Slide the solid waste drawer into the LIAISON®XL system (Figure 5-33).
7. Select the sub-category Summary of the category Status (refer to chapter 6.10.1) and press Reset button.

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Figure 5-30: Hook the bag to the back tensioner
Figure 5-31: Hook the bag to the front of the drawer

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Figure 5-32: Adjust the bag inside the drawer
Figure 5-33: Push the drawer into the cabinet

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5.5.7.2 Procedures with solid waste bin equipped
Unload 1. Open the cabinet (see chapter 4.1.5) and pull the solid waste drawer out of the LIAISON®XL system (Figure 5-25).
Procedure 2. Unhook the solid waste bag from the tensioner in the back of the drawer (Figure 5-26).
3. Unhook the solid waste bag from the front of the drawer (Figure 5-27).
4. Remove the solid waste bin (with the bag inside) from the drawer of the instrument (Figure 5-34).
Figure 5-34: Waste bin and bag removal
5. Close the solid waste bag with the dedicated strap (Figure 5-35).
6. Without removing it from the bin, bring the waste bag to the disposal point (Figure 5-36).
7. Once near the disposal point, dispose the bag once pulled it out of the bin.

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Figure 5-35: Bag closed with the strap
Figure 5-36: Bag inside the bin brought to disposal

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Load Procedure 1. Insert the solid waste bin into the solid waste drawer (Figure 5-37).
Figure 5-37: Waste bin insertion
2. Place a new solid waste bag into the solid waste bin.
3. Hook the solid waste bag to the tensioner (Figure 5-29) available in the back of the solid waste drawer (Figure 5-30).
4. Hook the solid waste bag to the front of the drawer (Figure 5-31).
5. Adjust the positioning of the bag inside the drawer (Figure 5-32), in order to guarantee the availability of the whole volume.
6. Slide the solid waste drawer into the LIAISON®XL system (Figure 5-33).
8. Select the sub-category Summary of the category Status (refer to chapter 6.10.1) and press Reset button.

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5.6 Load Patient Samples or Controls and Assign Assays
In this section, it is described how patient samples or controls are loaded into the system and how they can be assigned to one or several
assays.
5.6.1 Load Patient Samples
Sample
Preparation
Traceability of the Diagnostic Results

For maintaining traceability of the diagnostic results, the patient sample should be handled according to the
laboratories quality system as described in the local requirements.
Maintaining Safety
For maintaining safety, the samples must fulfil the requested installation and operating conditions as stated in the
assay instruction for use.

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Sample Area Flap closure

The sample area flap must be left open only for the time necessary to load sample racks. Leaving the sample area
flap open for more than 5’, the sample barcode reader will be disabled; in this case, it would be necessary to close
the sample area flap and open it to make it work again.
Due to certain mechanical restrictions and safety precautions, the sample to be used on the LIAISON®XL system must have the following
characteristics:
 Human serum, urine or plasma may be used (sample matrix depends upon assay intended use).
 The anticoagulants citrate, EDTA and heparin may be used (allowed anticouagulants depend upon assay intended use).
 Blood should be collected aseptically by venipuncture, allowed to clot, and the serum separated from the clot as soon as possible.
 Samples having particulate matter, turbidity, lipaemia, or erythrocyte debris may require clarification by filtration or by centrifugation before
testing.
 Grossly haemolyzed or lipaemic samples as well as samples containing particulate matter or exhibiting obvious microbial contamination
should not be tested.
 Check for and remove air bubbles before testing.
 Check that the sample volume is sufficient to run the required amount of tests (as described in the "Instructions For Use" on the kits being
used).
 In case of plasma gel separator containers, the amount of sample should be at least 500 µL plus the volume required to run the test.
Air Bubble Formation or Clotting

Air bubble formation or clotting of the samples must be avoided as these may alter the liquid detection functionality
and hence cause unreliable results. To avoid clots, the samples should be treated accordingly (e.g. centrifuged) prior
to the use in the LIAISON®XL system.
After all criteria have been observed concerning the sample quality, the samples must be inserted into tubes and then into sample racks. The
following procedure explains in detail the proper steps for doing so.

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Procedure  Only load and unload racks if explicitly requested to do so.

 Only load and unload racks on the specified lanes.
 Check the correct transfer/input of all reagent and sample names.
 Remove all caps from the sample tubes.

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Error at Loading/Unloading of Racks, Reagents and Samples

Improperly loaded or unloaded racks, reagents or samples can cause wrong results due to incorrect pipetting
activities.
Only tubes of the same type may be used for each rack, to avoid problems during the aspiration of liquids. The tube
type must be approved for the relevant rack.
Do not rotate bar-coded sample tubes after placement in sample racks. Rotating tubes when placed in sample racks
may cause damage to the bar-code and render the label unfit for future usage.
Use only exact modelling of tubes and bottles to ensure correct tracking.
1. Place the sample tubes in the sample racks.

 Sample tube diameter:
Use only sample tubes according to the used rack type (see chapter 4.2.5.3).
 Bar coded patient samples:
Make sure that the bar-code labels on the individual patient samples face left so that they can be scanned by the bar-code reader when
the rack is inserted.
 Non bar coded patient samples or unreadable bar-code labels:
When using non bar coded sample tubes or tubes with unreadable bar codes, the sample ID's (SID's) must be entered manually (see
below). Note that the SID manual entry practice is considered not state-of-art as a potential source of sample mismatch, out of the system
control, leading to wrong diagnostic results.
2. Open the sample loading bay flap.
The software will show automatically the Samples sub category tab of the Loading main category tab.

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See Laser safety in chapter 1.8.4.1.
Always use the rack handle when pushing in the racks into the rack system or pulling them out again.
3. Insert the first sample rack (carefully to avoid tipping over and spilling of bottles or tubes) into the sample loading bay on the lane marked
by the flashing LED. Place the rack in front of the lane and then push evenly up to the limit stop (with the tappet in the contact opening on
the rear panel).
The rack bar codes and the individual sample tube bar codes are read. If the rack has been inserted properly all the way, the LED goes off
for this position, and starts flashing at the next position that can be loaded.
4. If there is a problem with the rack identifier, an input box appears:
 Look at the rack label letter (rack identifier) on the front of the rack.
 Enter the rack identifier manually.
 Click on the OK button.
Never load more than one rack at a time! For proper bar-code identification the racks must be loaded one after
another, as indicated by the LEDs.

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Figure 5-38: Samples display

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1 ... 10 Lanes of the loading bay for sample racks.
The display is divided into two parts:
 Upper part:
Click on the upper part (lane number and indicator) of an empty lane to load a sample rack on
this lane.
The upper part reflects also the rack status via LEDs below the lane (see chapter 4.2.5).
 Lower part:
Click on the lower part (sample rack) to select a rack. All samples will be shown in the table on
the right side.
Control Opens the control picklist and allows the selection of a control or the creation of a new control
definition. The bar-code of that control is assigned to the current (empty) SID field.
The Control button is disabled if the SID field is not empty.
Rack log The Rack Log field shows information about a loaded or selected sample rack.
 Loading errors
 Positions without bar-code or unreadable bar-code
 SID problems (e.g. duplications)
Schedule Shows the Worklist tab to create or edit worklists for samples and controls (see chapter 6.3.1.1).
Standard buttons For standard buttons (e.g. arrow buttons, lock, Print) see chapter 6.1.
Table 5-7: Functions of the Samples sub category

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The samples table shows all positions of the selected rack.

Column Description
! Shows an exclamation mark for high-priority samples (STAT).
Type Shows an empty cell for samples or a symbol for calibrators and controls:
Calibrators
Controls

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SID Shows the sample ID, calibrator ID and control ID. The SID is read via bar-code scanner or
entered by operator (if bar-code not present or unreadable).
Notes:
The SID must be unique.
Two or more samples with the same SID are not allowed to load at the same time.
Use only the following characters:
 A - Z (a - z are converted to upper case)
 0-9
 minus (-), dot (.), dollar sign ($), plus (+), percent sign (%), number sign (#), ampersand (&),
and equal (=).
 The SID of controls may not begin with #.
A SID may be 3 to 17 characters long and may not contain spaces.
The SID of external calibrators begins with a predefined prefix character and contains the assay
abbreviation or article number.
Note:
The SID field is write protected, if any of the following applies:
 the rack is in "Error"
 the SID was read via bar-code (and accepted, i.e. not deleted because of duplication or illegal
character)
 the Control button was pressed for that SID at least once since the SID was recognized (i.e.
un-pressing that button does not allow typing, it's necessary to unload and reload the rack)
 either a workorder or a patient definition for that SID is present in the work-database (visible in
the sub category All of the main category Results, see chapter 6.4.1).

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Symbol See table below.
Pending If assays are assigned to the sample: Shows all assays in status Placed or Failed for the sample.
In Process If assays are assigned to the sample: Shows all started assays in status Scheduled, Active or
Measured for the sample.
Table 5-8: Columns of the loaded samples table
Light-Check must be loaded as an ancillary reagent.

Any sample beginning with the special characters (i.e. “#” or “$”) will be displayed as control or calibrator, no matter if
they will be treated as controls or calibrators or patient samples.
5. Note the Rack Log field for information about the loaded (or selected) sample rack. The Rack Log field shows:
 Loading errors
 Empty positions (positions without tubes, without bar-coded tubes or with tubes with unreadable bar-codes)
6. Click on the rack shown and check the sample ID's in the SID column of the table.
Symbol Description
Loaded sample tube with known SID.
Loaded sample tube without bar-code or unreadable bar-

code,
or
no tube loaded. The SID is empty.

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Sample in process.
Sample off-line
(If a sample is off-line, unload it, check its conditions and
reload again when ready for use.)
Table 5-9: Symbols
Sample IDs should not contain spaces. The system will deny spaces if entered manually via the on screen keyboard
or read via bar code.
7. Check all shown SID's of the loaded sample tubes.

An incorrect SID will be replaced by an empty field (check also the Rack Log): If so:
 Click on the affected SID cell.
 Enter the correct SID.
 Repeat the steps for all incorrect SID's.
8. Load the other sample racks in the same manner.
9. Close the sample loading bay flap.
5.6.1.1 Loading Error
It is possible to obtain an error while loading a sample rack.

Typical problems may include (but are not limited to):
 Damaged bar codes on the sample rack.

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 The sample rack is inserted too fast or too slow. Ask local service support for a tutorial about proper loading speed.
 The sample rack is inserted on the wrong lane.
 The bar-code scanner of the sample loading bay is damaged.
Errors with sample racks will appear immediately.

 The lane LED of the affected sample loading bay lane will be indentified by a flashing LED.
 The Samples display of the LIAISON®XL software shows an Error note on the loaded sample rack picture.
 The Rack Log on the Samples display shows an error message when that lane is selected..
Troubleshooting:
 Remove the sample rack.
 Check and correct the bar-code labels.
 Insert the sample rack again.
 If the system cannot recognize the rack, check the bar-code scanner of the sample loading bay with another sample rack, and call service
if the error occurs again.

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5.6.2 Assign Assays to the Patient Samples
Procedure 1. Click on the Loading main category tab.

2. Click on the Samples sub category tab.
3. Select a sample rack containing identified patient or control samples.
4. Click on the Schedule button to assign assays to the patient samples.
The LIAISON®XL software will show the Worklist tab.
Figure 5-39: Worklist tab

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Rack lane Shows the lane number of the selected sample rack. This button serves also as “Select/Unselect
All” button, if the “Lock button” is set to “closed”. Click on the arrow bottons next to the Rack lane
button to show another available sample rack, and the sample list will be updated.
Sample list Shows all samples, calibrators, and controls which are present in the selected rack.
Note: empty positions are not shown.
Table 5-10: Functions
Column Description
Position Tube position in the rack.
Type Shows an empty cell for samples or a symbol for calibrators and controls (see chapter 6.3.1).
SID Shows the sample ID, calibrator ID and control ID.
! Check the checkbox for high-priority samples (STAT).
Table 5-11: Columns of the rack samples table

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Selection Group The Selection group allows assigning assays (tests) to one or more samples.
Assay Selection Assays are organized in groups. First it is necessary to choose the assay group. After that it is
in Group possible to select one or more assays.
The display of an assay shows its relation to the samples:
 Colour:
 Blue: The assay is assigned to sample(s).
 Grey: The assay is not assigned to sample(s).
 Shape:
 Solid: Reagents for the assay are loaded.
 Broken with two stripes: Reagents for the assay are not loaded.
Profile Enables to select a profile (contains several assays, see chapter 6.6.5). Use the arrow buttons to
Selection show all available profiles.
Table 5-12: Functions of the Selection group
See chapter 6.3.1.1 for further details about the Schedule tab.
5. Use the arrows next to the Rack lane button to select the desired sample rack lane.
6. Check the ! checkbox for all high-priority samples (STAT).
7. Click on the desired row(s) in the table to select one or more samples.
Use the lock button to change the selection mode (see chapter 6.1):
 Opened lock: Only one sample entry can be selected (default).
 Closed lock: It is possible to select more than one sample entry.

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It is not possible to create a worklist for selected samples and controls at the same time. Select and work up samples
separate from calibrators.
It is possible to select and work up several samples or calibrators. Additionally click on the Lock button to use the
multiple selection function.
8. Select an assay group in the Assay Selection in Group selection box in the Selection sub tab.
9. Click on the desired assay button to select one or more assays.
Use the arrows next to the assays to show all assays of the group.
Style Description
The assay is:
 currently not loaded on the machine
 not assigned to the selected sample
The assay is:
 assigned to the selected sample
The assay is:
 currently loaded on the machine
The assay is:

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Table 5-13: Assay status
As soon as a test is started, it will no longer be selected and may be assigned again, even if the previous test is still
running
10. Select a profile (contains several assays).

Use the arrows next to the profiles to show all profiles.
11. There is the possibility to assign one or more dilution factors to the assigned assays in the Dilution group (see chapter 6.3.1.1).
12. There is the possibility to change the number of replicates to the assigned assays in the Replicates group (see chapter 6.3.1.1).
13. Assign the other samples with assays in the same manner.
14. There is the possibility to specify patient personal information for every sample in the Demographics group (see chapter 6.3.1.1).
15. Click on the Store button to confirm the assignment.
The LIAISON®XL software returns to the Samples display and shows the assigned assays in the Pending column.

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5.6.3 Load Controls and Assign to Assays
Note the safety notes (see chapter 5.7)!
Preparation Before the control is utilized by the user, it must first be prepared. The instruction on the packaging box must be strictly followed.
 Check that the control volume is sufficient to run the required amount of tests (as described in the "Instructions For Use" on the kits being
used).
 Check the control specific Instruction For Use for control specific preparation.
Definition Before controls can be used, the LIAISON®XL system must recognize the controls.
1. Click on the Definitions main category tab.
2. Click on the Control sub category tab, see chapter 6.6.2.
3. For Diasorin controls, click on the Scan button to open the Control Scan Dialog.
For controls not provided with the 2 dimensional barcode, it is possible to define the controls manually: see chapter 6.6.2
4. Scan the bar-code of the control(s) with the provided external bar-code scanner.
5. Click on the Ok button.
The LIAISON®XL system shows the control(s) in the controls table.
Do note remove the external barcode scanner while operating.
Loading 1. Load controls in the same way as patient samples (see chapter 5.6.1). The upper case conversion is not performed.
The field Type in the samples table shows a special symbol for controls.

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2. When using non bar-coded control tubes or tubes with unreadable bar codes, the control ID's (SID's)/control name must be chosen
manually:
 Select the desired position in the table.
 Click on the Control button.
 Select the desired control name entry.
Only defined controls may be selected (see chapter 6.6.2).
Note: in case two controls have been defined with the same name, the system proposes the control that expires later.
 Click on the Store button.
The LIAISON®XL system adds the control ID from the chosen control name automatically to the SID field.
Assigning 3. Assign controls in the same way as patient samples (see as described in chapter 5.6.2).
Do not mix controls and patient samples at assay assignment.

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5.7 Integrals, Calibrators, Ancillary reagents
Do not use reagents that have not been authorized for the LIAISON®XL system!
It is prohibited under any circumstances to change the components of one reagent to another even if the
reagents contain the same lot number.
 Failure to follow instructions “on the box” may result in rapid deterioration of reagent life or even
immediate expiration of reagent components.
 Handling of Reagent Integrals must be followed according the the Assay IFU’s.
 In order to avoid system delays and damage to Disposable Tips all caps must be removed from the
reagent tubes or bottles before introduction into the analyzer.
 In order to avoid tipping over and spilling of bottles or tubes racks must be inserted carefully.

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 Only tubes or bottles of the same type may be used for each rack, to avoid problems during the
aspiration of liquids. The tube or bottle type must be approved for the relevant rack.
 Always insert or remove the racks/integrals into the rack system with the handle.
 Never load more than one rack or integral at a time! For proper bar-code identification the racks must be
loaded one after the other, as indicated by the LEDs.
 Bar-code labels on integrals, ancillary reagents and starters are not used in the LIAISON®XL system.
 Note the Rack Log field for information about a loaded or selected rack (e.g. errors, empty positions).
5.7.1 Load Integrals
Integral Before an integral is utilized, it must first be prepared. The instructed markings on the packaging box of the integrals must be strictly followed.
Preparation
1. Remove the desired integral from the refrigerator keeping the integral in an upright position at all times.
2. Open the shipping box containing the integral and remove the integral.
3. Visually inspect the integral vials for leaking at the membrane seals or elsewhere. If the vials are found to be leaking, the local customer
service should be notified immediately.
4. Visually inspect the integral vials for bubbles. If bubbles are present the integral can not be immediately used. The integral must either set
until all bubbles resolve, or the bubbles must be removed before usage. (If bubbles are removed, it is important not to cross contaminate
vials)
5. Carefully remove the sealing flap of each vial by pulling the tab of the seal across the membrane in a slow fluid motion (pull only the tab in
order to prevent cross-contamination of the reagent integral vials).
6. Remove all liquid from the surfaces of the membranes to prevent cross contamination of the reagent integral vials.
7. Prepare the integral according to the related assay Instruction For Use

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Loading 1. Insert the integral into the integrated re-suspension tool (see chapter 4.1.2) and wait 30 seconds (unless otherwise specified in kit IFU).
2. Open the reagent loading bay flap.
The software will automatically show the Reagents sub category tab of the Loading main category tab.
Figure 5-40: Sub category Reagents

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Calibrate Starts the calibration of a selected integral.
For assays that share calibration within kit lot, this calibration will be available for all integrals of
that kit lot, no matter if loaded on-board or not. If the calibration cannot be started (e.g. external
calibrators not loaded) a pop-up will inform the user. In this case, no calibration will be created and
no jobs will be scheduled.
View Shows the calibration dialog and selects the valid calibration for the selected integral, if any.
Calibrations
Table 5-14: Functions of the Reagents sub category
Integrals Group Function Description

1 ... 25 Shows the integrals in the reagent loading bay lanes. Click on a loaded integral to show details
(see 'Group Details').
Table 5-15: Functions of the Integrals group
Details Group Function Description

Abbreviation Abbreviation of the assay.
Article No. Identification code of the selected integral that allows the LIAISON®XL system to associate the
integral to an assay.
Booked Tests Assigned but not started tests.
Calibration Status of the calibration (e.g. valid, not valid).
Status
Expiry Date Date and time when the reagent integral will expire. Note: this is the last day when that reagent
integral is allowed to beused.

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Integral Layout Parameter that allows the LIAISON®XL system to identify the geometric characteristics of the
integral
Integral Status Status of the integral availability:
 Online: The integral is useable
 Offline: The integral cannot be used. The abbreviation is shown in grey.
Possible reasons:
 No liquid found.
 The expiration date is exceeded.
 The reagent has a data recognition issue.
 The compatible assay protocol version is not loaded.
Kit No. Kit number of the reagent integral.
LIS alias Assay name on the LIS system.
Lot No. Lot number of the reagent integral.
Master Curve ID The ID of the master curve used for this reagent integral.
On-board expiry Last date when the reagent integral can be used once it has been inserted on-board.
date
Original No. of Max. number of tests with a new integral.
tests
Remaining Remaining number of calibrations.
Calibrations
Remaining Remaining number of determinations for the selected integral.
Tests
The number is updated (decremented by one) as soon as the first aspiration event for a
determination occurs.
Table 5-16: Functions of the Details group

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3. Insert the first required integral into an empty lane of the reagent loading bay.
The LIAISON®XL software reads the RFID tag of the integral and shows the information about the integral on the display.
4. Load the other required integrals in the same manner following steps 1-3.
5. Close the reagent loading bay flap.
6. Check all loaded integrals (see chapter 5.7.1.1).
5.7.1.1 Check Integrals
Check the loaded integrals to ensure that:

 No load error (RFID reading error) occurred
 Integral to be used has a valid calibration status
 The number of remaining tests is sufficient

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Lane number
Assay name or ERROR
Calibration status (see table below)
Number of remaining tests

Agitation countdown time:
The agitation countdown time starts with 15:00 min. and stops at 00:00 min. When it
reaches 00:00, the integral can be used (unless otherwise stated in the kit IFU).
Symbol Description
no symbol No specific symbol is shown if the integral has a valid calibration.
A yellow bar indicates that an expired calibration is present.
A red bar indicates that no valid calibration is present.
A calibration is ongoing for the integral.
Table 5-17: Calibration status

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The symbol shall be considered effective only after the Finish time will be displayed on the header (see chapter
6.2).
5.7.1.2 Particular Aspects of Loading Reagents in Combi-Assays
When inserting the reagent integral of a combi-assay followed by the assignment of this assay to a sample, more measuring results can be
obtained: those of the combi-sons and the one of the combi-assay.
5.7.1.3 Lot Binding (Lot Locking)
An assay may require more than one integral for a run. The LIAISON®XL system shows the binding between the integrals in the Reagents
sub category. When selecting one integral, the other compatible integrals will be marked with a blue frame.
5.7.2 Calibrate Integrals

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A calibration cannot be started if any of the following occurs:
 another calibration is ongoing for the same integral
 another calibration is ongoing for another integral of the same lot (if that assay shares the Working Curve)
 the calibrators are external and not present onboard
 starters, calibrators, reagents are missing or empty
 starters or reagents are expired
Preparation Before an integral is utilized, it must first be prepared. The instructed markings on the packaging box of the integrals must be strictly followed.
1. Remove the desired integral from the refrigerator keeping the integral in an upright position at all times.
2. Open the box containing the integral and remove the integral.
3. Visually inspect the integral vials for leaking at the membrane seals or elsewhere. If the vials are found to be leaking, the local customer
service should be notified immediately.
4. Visually inspect the integral vials for bubbles. If bubbles are present the integral can not be immediately used. The integral must either sit
until all bubbles resolve, or the bubbles must be removed before usage. (If bubbles are removed, it is important not to cross contaminate
vials).
5. Carefully remove the sealing flap of each vial by pulling the tab of the seal across the membrane in a slow fluid motion (pull only the tab in
order to prevent cross-contamination of the reagent integral vials).
6. Remove all liquid from the surfaces of the membranes to prevent cross contamination of the reagent integral vials.
7. Prepare the integral according to the related assay Instruction For Use.
Loading 1. Load the integral (see chapter 5.7.1)

2. Load additional calibrators in the same way as patient samples (see chapter 5.6.1).
The field Type in the samples table shows a special symbol for calibrators.
3. Click on the Reagents sub category tab of the Loading main category tab.

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4. Select the affected integral in the Reagents sub category.
5. Click on the Calibrate button.
The calibration will start automatically.
When the calibration is completed, it will be automatically accepted or rejected.
6. When the calibration is completed, check if the calibration status of the affected integral is valid.
If not, exchange the integral.

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Calibration  Select the affected integral in the Reagents sub category and click on the View Calibrations button.
Report or
 Click on the Calibrations sub category tab of the Results main category tab.
 All calibrations (valid, failed, expired…) are stored on the system database: See Calibrations sub category tab
of the Results main category tab (chapter 6.4.7).
 A sample test can be performed without a valid calibration: in this case, only RLU results will be given; the
system will automatically assign a dose to all sample results performed within the last 18 hours that have an RLU
and not a dose.

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5.7.3 Load Ancillary reagents
Preparation Before the ancillary reagents are utilized by the user, they must first be prepared. The preparation includes also the pre-storage. The
instructed markings on the packaging box must be strictly followed.
1. Remove the desired ancillary reagent from the refrigerator keeping it in an upright position at all times.
2. Open the box containing the ancillary reagent and remove it.
3. Visually inspect the ancillary reagent for leaking. If any leaking is found, the local customer service should be notified immediately.
4. Visually inspect the ancillary reagent for bubbles. If bubbles are present, the ancillary reagent can not be immediately used. The ancillary
eagent must either set until all bubbles resolve, or the bubbles must be removed before usage.
5. Prepare the ancillary reagent according to the related assay Instruction For Use.
Loading 1. Open the reagent loading bay flap.

The software will shown automatically the Reagents sub category tab of the Loading main category tab.
2. Click on the Ancillary sub category tab.

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Figure 5-41: Sub category Ancillary
Withdraw If it is necessary to remove the ancillary rack during a run, press this button to suspend the
pipettor access. Insert the furthermore used ancillaries as soon as possible
Note: this could lead to test failures.
Table 5-18: Functions of the Ancillary sub category

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Column Description
No. Position of the ancillary reagent in the ancillary rack (1 to 4).
Name Name of the ancillary reagent.
Art No. Article number of the ancillary reagent (the color represents the cap color).
Lot No. Lot number of the ancillary reagent.
Serial No. Serial number of the ancillary reagent.
Exp. date Date and time when the ancillary reagent will expire.
Use by Onboard stability expiration date.
Volume Available liquid volume in the bottle.
Bound lots If there is an entry: It is only possible to use integrals of the related assay with the reported lot
number.
Table 5-19: Columns of the Ancillary sub category table
Some fields may be empty for ancillary reagents not to be used during a routine (i.e. Light Check).
Off-line Status If an ancillary reagent is off-line, the description text is displayed in grey.
Possible reasons:
 No liquid found
 The ancillary reagent has a data recognition issue.
3. Remove the ancillary rack (see chapter 4.2.6).

4. Place the ancillary reagent in the ancillary rack.

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5. Insert the ancillary rack into the left lane of the reagent loading bay.
The LIAISON®XL software reads the RFID tag of the ancillary reagent and shows the information on the display.
See chapter 5.6.1.1 for details about loading errors.

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5.8 Start Worklist
After the checking, loading and assigning of all resources, the LIAISON®XL system can start the preparation and evaluation of the samples.
Procedure 1. Click on the Start button in the header.
The LIAISON®XL system starts with the worklist.
2. Click on the Loading main category tab.
3. Click on the Samples sub category tab.
Processed samples are marked with a symbol and the assay names are shown in the In Process column of the table. See chapter 6.3.1
for all details.

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Figure 5-42: Samples display - running worklist

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5.9 Results
On the LIAISON®XL system, it is not necessary to wait for the entire processing to be finished to view the results. As soon as the processing
of one patient sample test, calibration, or control is finished, the system generates the result for it.
The completed results can be accessed via the main category Results as well as its several sub categories.
Sub Description Procedure Further

Category Details
All The sub category All shows all entries of - chapter
applied, started, and finished worklists. 6.4.1
Done The sub category Done shows only entries chapter chapter
of finished worklists with status Done. 5.9.1 6.4.4
Failed The sub category Failed shows only entries chapter chapter
of finished worklists with status Failed. 5.9.2 6.4.6
Calibrations The sub category Calibrations shows only chapter chapter
calibration entries (either valid, expired and 5.9.3 6.4.7
failed calibrations).
Controls The sub category Controls shows the chapter chapter
results of the controls. 5.9.4 6.4.8
Table 5-20: Sub categories of the main category Results featuring completed results.

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5.9.1 Results of Patient Sample Tests (Status Done)

Use the sub category Done to show only patient sample entries of finished tests with status Done.
Procedure 1. Click on the Results main category tab.

The LIAISON®XL software shows the sub category All.
2. Click on the Done sub category tab (see also chapter 6.4.4).
Figure 5-43: Sub category Done

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Archive Archives the currently selected entries. The archived entries will be shown in the sub category
Archived
Note: This button is available only if automatic archiving is not enabled.
Delete Deletes one or more entries (see chapter 6.4.1.4). The deleted entries get the status Deleted and
will be shown in the sub category Deleted.
Details Opens the Result Details display for the selected entry (see chapter 6.4.1.3).
Export Opens the Export display to export one or more entries to a text file (see chapter 6.4.1.2).
Filter Opens the Select Filter display (see chapter 6.4.1.5).
Recalc Recalculates the currently selected entries, using the most recent calibration for the assigned
assay.
Rerun Reruns all or only the selected entry/entries.
Table 5-21: Functions of the Done sub category
The usage of the Recalc feature may lead to modifications of already reported results: use it only in accordance
with laboratory procedures and local regulations.
If using the Recalc feature when no valid but expired calibrations are available, the system may use any calibration
among the expired calibrations to calculate the dose.
Column Description
Sample ID Shows the sample ID.
Assay Shows the assigned assay.
Measured Date Result date and time.

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Dilution Factor Multiplication factor for the result (only for diluted tests).
RLU Shows the raw result (in Relative Light Units).
Result Shows the dose result in user units.
Unit User defined units.
Qualitative Shows the result as qualitative evaluation (e.g. positive, negative etc.)
Label
Flags List of all flags. For details about the flags see chapter 5.9.5.
Table 5-22: Standard columns of the “Done” samples table
3. Pay attention to the Flags column!

See chapter 5.9.5 for the used flag abbreviations.
Dose calculation will be done automatically by the system as soon as a calibration is successful performed, provided
that the following conditions are met:
 the samples are successfully analysed but without a dose (i.e. in status Measured),
 the samples were run with the same kit (if the curve is not shared) or with the same lot (if the curve is shared),
and
 the samples were run not before 18 hours (after sample RLU result is available).
5.9.2 Results of Patient Sample Tests (Status Failed)

Use the sub category Failed to show only patient sample entries of finished tests with status Failed.


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2. Click on the Failed sub category tab (see also chapter 6.4.6).
Figure 5-44: Sub category Failed
Archived
Delete Deletes one or more entries (see chapter 6.4.1.4).

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assay.
Rerun Reruns the selected routine
Table 5-23: Functions of the Failed sub category
The usage of the Recalc feature may lead to modifications of already reported results: use it only in accordance
with laboratory procedures and local regulations.
If using the Recalc feature when no valid but expired calibrations are available, the system may use any calibration
among the expired calibrations to calculate the dose.
Column Description
Table 5-24:Standard columns of the “Failed” samples table

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5 Use of the System
3. Perform the next steps accordingly to the laboratory processes:

 Details: Shows details for a selected sample entry.
 Recalc: Recalculates the currently selected entries.
 Rerun: Reruns all or only the selected entry/entries.
5.9.3 Results of Calibrations

Use the sub category Calibrations to show only entries of all calibrations.

2. Click on the Calibrations sub category tab (see also chapter 6.4.7).
3. Pay attention to the Status column!
See chapter 6.4.7 for the used status abbreviations (Created, Failed, Invalid, Valid, Expired, NotUsed).

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5 Use of the System
5.9.4 Results of Controls

Use the sub category Controls to show only entries of all controls.

2. Click on the Controls sub category tab (see also chapter 6.4.8).
3. Pay attention to the Flags column!
See chapter 5.9.5 for the used flag abbreviations.
5.9.5 List of Flags
A flag on results indicates that something happened during the run that may have affected the result on this sample.
The system will not report results in case of detected process anomalies.
Not reported results carry flags in order to describe the process anomalies for which that result was not reported.
Reported results may carry flags in order to inform users about the special conditions under which that result was
reported.
Each result flag may belong to one of two tables.

 If a flag from the ”invalidating flags” table is set, then the result is not reported;
 If a flag from the “informative flags” table is set, then the result is reported.
The column “Retry” tells whether a replicate may be retried without user invention or not. If it is not retried, it is set to "Failed". If it is retried
unsuccessfully a pre-defined number of times, it is also set to Failed. The retry feature is configurable by local service support.
The column “Applies to” defines to which Result the Flags are applied:
 R: Replicate,

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5 Use of the System
 W: WorkOrder (entire sample test, in case of 2 or more replicates), and
 C: Combi Assay.
The Column “Inherits” defines which result inherits the flag.
Invalidating Flags Abbr. Description Explanation Retry Applie Inherit

s to s
* Agitation speed The magnetic particel agitation was out of range while No R W,C
out of range. pipetted.
* Aspiration One aspiration did not occur in the defined time slot. No R W,C
plausibility failure
* Cycle occupation The system detected a conflict in scheduled activities. Yes R W,C
failure (normal,
dilution)
* Disposable tip The system did not have disposable tips available. Yes R W,C
not present.
* Disposable Tip The system could not pick a disposable tip assumed Yes R W,C
Pickup failure available.
* High background Too high noise in the Reader No R W,C
in PMT.
* Incubator Incubator temperature was out of range when the test was No R W,C
temperature out processed.
of range.
* Internal failure An internal error occurred. No R W,C
detected.
* Job scheduling A job scheduling failure occurred. Yes R W,C
failure
* Liquid Container A liquid container was empty. No R W,C
empty.

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5 Use of the System
Abbr. Description Explanation Retry Applie Inherit
s to s
* Measurement The system detected an error in the Reader. Yes R W,C
Chamber failure
* Mechanical error. A mechanical error occurred on the system. No R W,C
* No cuvette No cuvette was available to process the job. Yes R W,C
available
* No Mitigation No successful mitigation was performed Yes R W,C
Step performed
* Reagent pipetting A reagent was not pipetted (e.g. pipettor was paused). No R W,C
step not
executed.
* Sample pipetting A sample was not pipetted (e.g. pipettor was paused). No R W,C
step not
executed.
* Pipettor offline. The test could not be pipetted when needed. No R W,C
* Waste container Processing aborted due to full waste container. No R W,C
full.
* Starter Dispense The liquid volume aspirated from the cuvette after the Yes R W,C
Verification measurement step was lower than expected.
failure
* Starter lot change A replicate could not start due to a starter lot change No R W,C
meanwhile occurred.
* Starter reagent A scheduled Starter prime could not occur. No R W,C
temperature out
of range.
* Starter prime not Starter reagent temperature was out of range when the Yes R W,C
performed. test was processed.
* Timing violation. The pipettor was overloaded. No R W,C

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5 Use of the System
s to s
* User requested The test was aborted as per user request. No R W,C
abort
* Washer An aspiration failure was detected in the washer. Yes R W,C
aspiration failure.
C No calibration No usable calibration found. No R W,C
D Overdiluted The sample was over diluted. (Only for samples with No R W,C
sample specific dilution)
M Mathematical Math error occurred while calculating dose. No R,W,C W
error
R Ancillary not A needed ancillary was not found (vial not present or No R W,C
present. offline).
R Reagent The reagent pipettor arm found no liquid. No R W,C
depleted.
R Reagent integral A needed integral was not found (integral not present or No R W,C
not present. offline).
R Reagent integrity An aspiration or dispense failure was detected by the No R W,C
failure. reagent pipettor.
S Clot in sample An aspiration failure was detected by the sample pipettor No R W,C
detected
S Sample depleted. The sample pipettor arm found no liquid. No R W,C
S Sample integrity An aspiration or dispense failure was detected by the No R W,C
failure. sample pipettor.
S Sample not The sample was not found (tube not present or offline). No R W,C
present.
X< Combi Son Any combi son is below the assay range. No C
Below Assay
Range

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5 Use of the System
s to s
X> Combi Son Any combi son is above the assay range. No C
Above Assay
Range
XM Combi Son has Any combi son has a math error in dose calculation. No C
mathematical
error
Z Divided by zero For calculation of a combi assay result a division by zero No C
occurred
Table 5-25: List of invalidating flags (in alphabetical order)

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5 Use of the System
Informative Flags Abbr. Description Explanation ApTo Inher

& Rerun This Result matched a Rerun Rule (for patient samples W
only).
< Below assay The calculated dose is below the assay range R,W,C
range
> Above assay The calculated dose is above the assay range. If the R,W,C
range assay range high limit is not defined, than the
concentration of the last standard may be used
(depending on assays).
C Calibration The calibration used for calculation was expired. R W,C
expired
E Reagent On The used integral or ancillary had the onboard expiration R W,C
Board Stability date overdue.
Expired
NH Above normal The calculated dose is above normal range (not for R,W,C
range calibrators and controls).
NL Below normal The calculated dose is below normal range (not for R,W,C
range calibrators and controls).
Q Controls out of Only for samples. R,W,C
manufacturer
Not generated if the range is empty, for “precision”
range
controls - based on last performance of any “control
name” defined for that assay.
QE Control expired The control used was expired R W,C
QH QC above Only for controls. R,W,C
manufacturer
In case the control is above assay range, this flag is
range
generated as well.
Not generated if the control range is empty, for “precision”
controls.

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5 Use of the System
Abbr. Description Explanation ApTo Inher
QL QC below Only for controls. R,W,C
manufacturer
In case the control is below assay range, this flag is
range
generated as well.
controls.
RM Recalculated The result was recalculated upon user request. R W,C
UH QC above user Only for controls. R,W,C
range
In case the control is above assay range, this flag is
generated as well.
controls.
UL QC below user Only for controls. R,W,C
range
In case the control is below assay range, this flag is
generated as well.
controls.
X& Son Rerun A combi son matched a Rerun Rule (for patient samples C
only).
XNH Son above A combi son was above the Normal Range. C
normal range
XNL Son below A combi son was below the Normal Range. C
normal range
Table 5-26: List of informative flags (in alphabetical order)

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5 Use of the System
Flag Mask For reporting purpose some flags mask some other flags, i.e. : the presence of a flag avoids another flag of lower importance.
For example, a result with flag “S” is not provided with flag “C”, even if the calibration was expired.
Combi Results For combi assay results some flags reflected the presence of a flag into any combi son results.
The flag for a Combi Son… … becomes the flag for its Combi
Father
Math Error Son Math Error
Below Assay Range Son Below Assay Range
Above Assay Range Son Above Assay Range
Below Normal Range Son Below Normal Range
Above Normal Range Son Above Normal Range
CausedRerun Son CausedRerun
Table 5-27: Combi results flags

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5 Use of the System
5.10 Routine errors
If an error occurs that could compromise the integrity of the system or could fail a significant amount of results, the run is automatically
stopped. A message box with a message describing the error is displayed. Error messages have to be confirmed
Figure 5-45: Event Log Message
All errors and events can be shown in chapter 6.5.
Error messages are described in chapter 9.1.
If the error reoccurs, please call service.

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5 Use of the System
5.11 Unloading
It is possible to unload unused sample racks or integrals. The LIAISON®XL system shows unused resources.
5.11.1 Unload Sample Racks

Potential infectious material and all parts that may come in contact with potential infectious material must be
disposed according to the local and national provisions, legislation and laboratory procedures.
Error at Loading/Unloading of Racks and Samples

Improperly loaded or unloaded racks or samples may cause wrong results due to incorrect pipetting activities.
 Only load and unload racks if explicitly allowed by corresponding LED (see chapter 4.2.5).
Use of Racks
Remove the racks carefully out to avoid tipping and spilling of bottles or tubes.
Always remove the racks by the handle.

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5 Use of the System
Never unload more than one rack at the same time.
Unload all sample racks before shutting the LIAISON®XL system down.
1. Observe the LEDs under the sample loading bay lanes.

2. If there are LEDs off, but the lanes are occupied, then open the sample loading bay flap.
3. Hold the handle of an unused sample rack and push the sample rack against backside. Note the audible click.
4. Remove the sample rack carefully.
5. Unload other unused sample racks.
6. Close the sample loading bay flap.
Patient Samples:
If the sample tubes are not empty and will be used at a later date:
 Cover and store the patient sample according to laboratory regulations/specifications.
If the sample tubes are empty:

 Discard tubes or bottles in an appropriate manner.

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5 Use of the System
Controls and Calibrators:
If the control or calibrator is not empty:

 Place the appropriate cap on the control or calibrator.
 Place the control or calibrator in a tray in an upright position (if available).
 Place the tray into the refrigerator (see storage information in the control or calibrator instruction).
 If a tray is not available, place the control or calibrator bottle into the refrigerator in a secure upright position.
If the control or calibrator is empty:

 Discard the control or calibrator in an appropriate manner.
Use of Controls and Calibrators

Do not use controls or calibrators that have not been authorized for the LIAISON®XL system environment.

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5 Use of the System
5.11.2 Unload Integrals


Improperly loaded or unloaded racks, reagents or samples may cause wrong results due to incorrect pipetting
activities.
 Only load and unload racks if explicitly allowed by corresponding LED (see chapter 4.2.6).
Use of Integrals
Remove integrals carefully out to avoid tipping and spilling of integrals.
Do not remove integrals still in use.
Always remove the integrals by the handle.

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5 Use of the System
Never unload more than one integral at a time.
1. Observe at the LEDs under the reagent loading bay lanes.

2. If there are LEDs off, but the lanes are occupied, then open the reagent loading bay flap.
3. Hold the handle of an unused integral and remove it carefully in an upright position.
4. Unload other unused integrals.
If the integral is not empty:

 Place the integral in an integral tray in an upright position (if available).
 Place the integral tray into the refrigerator (see storage information in the integral instruction for use manual).
 If an integral tray is not available, place the integral into the refrigerator in a secure upright position.
If the integral is empty:

 Discard the integral in an appropriate manner.
Use of Integrals
Do not use integrals that have not been authorized for the LIAISON®XL system environment.

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5 Use of the System
Use of Integrals
It is prohibited under any circumstances to modify the integral setup.
5.11.2.1 Proper Storage and Handling of Integrals
Store the integral according to the related Instruction For Use.

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5 Use of the System
5.11.3 Unload Ancillary Reagents


Improperly loaded or unloaded racks, reagents or samples can cause wrong results due to incorrect pipetting
activities.
 Only load and unload racks if explicitly requested to do so.
Use of Ancillary Rack

Pull the ancillary rack carefully out to avoid tipping and spilling of bottles.
Do not remove ancillaries that are still in use.
Always remove the ancillary rack by the handle.

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5 Use of the System
1. Look at the left LED under the reagent loading bay lane (lane “A”).
2. If the LED is off, but the lane is occupied, then open the reagent loading bay flap.
3. Hold the handle of the unused ancillary rack and remove it carefully keeping it in an upright position.
If the ancillary reagent is not empty:

 Place the ancillary or reagent in a tray in an upright position (if available).
 Place the tray into the refrigerator (see storage information in the ancillary or reagent instruction for use manual).
 If a tray is not available, place the ancillary or reagent bottle into the refrigerator in a secure upright position.
If the ancillary or reagent is empty:

 Discard the ancillary reagent in an appropriate manner.
Use of Ancillary Reagents

Do not use ancillary reagents that have not been authorized for the LIAISON®XL system environment.

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5 Use of the System
5.12 Shut Down/End of Day Maintenance
The LIAISON®XL can be left on after the routine completion without any special precautions. The system
automatically goes into a “stand-by” condition after some time of inactivity.

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6 Software Functions
In this chapter, the complete LIAISON®XL software is described in detail. Hereby, the main focus is not on the general context and the
processes but on a complete description of all functions, buttons, lists etc. This chapter can therefore be considered as a reference book for
the LIAISON®XL software.
Software functions not described in this chapter are for field service engineers and developers only. All other users
do not have access rights for these special functions.
6.1 General
In this subchapter, functions are described which can be used in the complete LIAISON®XL software.
Function Symbol Description
Cancel Dismisses all changes and returns to the previous display.
Help Shows the online help (see chapter 6.1.1).
Multiselect Activate the multiselect function to select more than one entry in a list.
 Opened lock: Multiselect function is deactivated (default)
 Closed lock: Multiselect function is activated

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OK Confirms/saves all changes and returns to the previous display.
Print Click on this button to show the printer dialog (see chapter 6.1.3).
Scroll buttons Jump to the first/last page (active in case of multiple page documents).
Scroll buttons Jump to the previous/next line (active in case of multiple page documents).
Scroll buttons Jump to the previous/next page (active in case of multiple page documents).
Scroll buttons Jump to the previous/next values (active in case of multiple page documents).
Search Searches for the entered text (text field next to the button) and shows the results in
the table (see chapter 6.1.2).
Store Confirms/saves all changes and returns to the previous display.
Table sort order Sorts the rows of a table in ascending or descending order.
Click on a table headline to start the sorting. After the sorting one of the arrows are
shown next to the headline.
See chapter 6.1.2
Total Records Shows the number of rows in the table.
Table 6-1: General functions

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In some cases it is not possible to select another sub or main category. In this case a function with separate tab (e.g.
details) has been selected. Click on the OK, Store, or Cancel button to return to the sub category.
During time consuming operations typically involving a relevant amount of data, the system time (reported on the
header, see chapter 6.2) will be frozen. Once the operation has been concluded, the system will start again updating
the system time.
Multiselection
The multiple selection is guaranteed by ensuring that the related symbol is shown in the closed status: .
Performing multiple selections with the symbol shown in open status does not guarantee that all the selected items
will be processed during the subsequent requested actions (e.g. printing).

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6.1.1 On-line Help

The Help button provides access to all operating instructions and information necessary to run the system. The on-line help system is
comprised of several section tabs:
 The User Manual tab shows the on-line version of this manual.
 Short instructions to use the LIAISON®XL system are shown on the Quick Guide tab.
 The Glossary tab shows explanations about several used technical terms.
 Help regarding issues with the LIAISON®XL system is available through the Troubleshooting tab.
 The Assays tab shows information about assays.
 The Controls tab shows information about controls.
 The References tab shows information about assay references.
 The Symbols tab shows information about assay symbols.
The tabs Assays, Controls, References and Symbols are filled with the content of the mini-CD currently loaded in the CD drive. Upon
removal of the mini-CD, the information could be still available for a certain amount of time.
When selecting the Help button, the system on-line help is shown.

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Figure 6-1: Online Help screen
< or > Jumps to the previous or next page of the shown help.
Back Returns to the LIAISON®XL software main screen.
Home Jumps back to the first/main page of the shown help.
Print Prints the shown information.
Table 6-2: Functions of the Online Help

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6.1.2 Sorting and Searching

This function allows the user to sort the table entries or to search for entries.
Function Symbol Description

Search Searches for the entered text (text field next to the button) and shows the results in
the table. If there are no hits, the table will be empty.
Non alpahumerical characters may be ignored.
Table sort order Sorts the rows of a table in ascending or descending order.
Click on a table headline to start the sorting. After the sorting one of the arrows are
shown next to the headline.
Columns, that do not support sorting, will not show any arrow.
Non alpahumerical characters may be ignored.
Table 6-3: General functions
Sorting To view the table contents, it is possible to sort the shown entries.
Procedure:
1. Click on one of the table headlines to sort the complete table.
2. The entries will be sorted on the basis of the text in the selected column.
3. A small arrow next to the headline shows the sort order:
Ascending sort order All entries are sorted from 0 to 9 and A to Z
Descending sort order All entries are sorted from Z to A and 9 to 0

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For items where the logical content is more relevant than the alphabetical content, the sort order may be not
alphabetical but logical (e.g. the “Status” column for test results can be sorted according to a pre-defined non
alphabetical order that follows the natural sequence of status for a test).
The sort function is case insensitive (e.g. the item “Sample_01” is equivalent to the item “SAMPLE_01”).
Examples:
 Unsorted entries:
Column 1 Column 2
Sec_1_ID_2 Failed
Doc_34_ID_10 Done
Sec_1_ID_5 Failed
Sec_1_ID_22 ToDo
 Selected: Column 1 / Sort order: Ascending
Column 1 Column 2
Doc_34_ID_10 Done
Sec_1_ID_2 Failed
Sec_1_ID_22 ToDo
Sec_1_ID_5 Failed
 Selected: Column 1 / Sort order: Descending

Rev. D
Column 1 Column 2
Sec_1_ID_5 Failed
Sec_1_ID_22 ToDo
Sec_1_ID_2 Failed
Doc_34_ID_10 Done
 Selected: Column 2 / Sort order: Ascending

Column 1 Column 2
Doc_34_ID_10 Done
Sec_1_ID_2 Failed
Sec_1_ID_5 Failed
Sec_1_ID_22 ToDo
Searching As the system is used the result and events table’s entries will increase. To find particular entries it is possible to search for these entries.
Figure 6-2: Search entry field
Procedure:
1. Click on one of the table headlines to select the used column for the search process.
Note, the sort order of the column (see above).
2. Select the Search field.
3. Enter a text to search for.
Note that all search results must begin with this text.

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4. Click on the Enter key to close the keyboard from screen.
The LIAISON®XL software shows the first entry of the found entries. If it was already visualized, nothing on the page changes, otherwise
the system scrolls the page to the first matching entry.
5. Use the scroll buttons to look for the other found entries.
The search function shows always all entries. The function jumps entirely to the first entry of the found entries.
According to the sort order, the first found entry is the topmost entry in ascending order. The last entry is the topmost
entry in descending order.
When the search function is used, the item selection is not related to the outcome of the search.
Examples:
 Entries:
Doc_34_ID_10
Doc_39_ID_2
Sec_1_ID_5
Sec_1_ID_5
Sec_2_ID_7
Sec_2_ID_9
Sec_3_ID_4
 Search text: Sec_
 First entry found: Sec_1_ID_5
 Search text: Sec_2
 First entry found: Sec_2_ID_7

Rev. D
 Search text: (empty)
 First entry found: Doc_34_ID_10

Rev. D
6.1.3 Print Reports

It is possible to print the information (e.g. results, events, or assays) reported by the LIAISON®XL software.
1. Select desired entries.

2. Click on the Print button.
The LIAISON®XL software shows an adapted dialog.
Figure 6-3: Print Report dialog (e.g. result report)
3. Select the print options:

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 Selected Records: Prints only the selected entries
 Today’s Records: Prints only today’s entries
 All Records: Prints all entries
 Range: Activates the range section to specify the printed entries, filling the fields From and To
 Report: If more print templates are available, choose the preferred one.
4. Click on the OK button.
In case the print queue should be deleted, it is necessary to interact with the printer itself, as the system does not
allow access to the operating system functionalities related to managing the printer.

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6.2 Header
Figure 6-4: Header
Status Current system status, see Table 6-5: Status
Cycle Shows the total number of operativity cycles for the instrument.
Date Shows the current date.
Finish time Estimated finish time of the run.
Software Release version of the LIAISON®XL software.
Version
Start Starts the tests in status “placed”.
Stop Calls the STOP Menu to pause, shutdown or init the system, see chapter 6.2.1.
Support Gives access to the On-line help, see chapter 6.1.1.
Time Shows the current time.
Username The currently logged in user is shown in the middle of the upper line.
Table 6-4: Functions of the Header
In case of LAS mode ON the Finish time can be persistently shown as “Calculating”

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Status Status Description

Descriptions Not Initialized The system is not initialized: if the instrument is connected, the initialization will be started upon
pressure of the Init button from the STOP Menu.
Note: this is a non functional status. As long as the system stays in this status, there is no
guarantee about the system hardware functionalities, including (but not limited to) reagent cooling,
magnetic particles re-suspension, cuvette movement.
Initializing The system performs all actions required for mechanical initialization of all modules (e.g. from un-
powered start or by user request). The database integrity is also checked.
Standby All modules are operational, but no tests are running. All subsystem temperatures are maintained
at specified temperatures. The LIAISON®XL system will take the motor drivers offline (power-
safe). The LIAISON®XL software allows starting a new run: the system will take care of performing
the necessary activities (including primes).
In Standby mode the system supports loading of reagent integrals, samples and ancillaries.
Cuvette loading is limited because the incubation ring does not turn.
When switching from standby mode to normal operation the power-saving subassemblies are re-
initialized.
Maintenance This status is reached in two possible situations:
1. The user requested a routine while the system was in Standby status: the system sets all
assembies in normal mode and performs automatically the priming procedures.
2. The user requested a maintenance task: the system performs the foreseen maintenance
activities, while it is not possible to navigate into the graphical interface.
Ready The system is considered ready for assay processing. The LIAISON®XL software allows starting a
new run.
The LIAISON®XL system returns into Ready mode when the run is finished and can be started
again after test scheduling. After a predefined timeout, the system will return in Standby mode.
Running The LIAISON®XL system is performing tests.
New tests can also be started while the system is in Running mode.

Rev. D
Status Description
Diagnostics The user has requested the system to perform a diagnostic task.
Halted A fatal error occurred and all activities are stopped. The previous state is not recoverable.
The Halted mode can be reached from all other states. All ongoing tests will be failed.
Note: this is a non functional status. As long as the system stays in this status, there is no
guarantee about the system hardware functionalities, including (but not limited to) reagent cooling,
magnetic particles re-suspension, cuvette movement.
Table 6-5: Status
6.2.1 Stop Menu
Figure 6-5: STOP Menu
Pause Pauses the pipettor.
If the pipettor is paused already, then the button is labelled Continue. Click on the Continue
button to restart pipetting. Tests not started yet will be set to “Placed”. Tests already started will be
set to “Failed” if the pipettor would be necessary.
Shutdown Shuts down the LIAISON®XL software and the computer. Any ongoing test will be interrupted and
cannot be recovered. The next incoming pop-up allows to confirm or to abort the shutdown.
Init Aborts all ongoing operations on the instrument (if the system is running) and starts a re-
initialisation.

Rev. D
Cancel Closes the STOP Menu and returns without any changes to the previous display.
Table 6-6: Functions of the STOP Menu
While the STOP Menu is in the foreground the run is not stopped.

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6.3 Main Category Loading
With the main category Loading, the LIAISON®XL system can be completely loaded and unloaded with samples, integrals and ancillaries. In
addition to the loading/unloading, samples can be assigned to assays via the subcategory Samples.
6.3.1 Sub Category Samples

The subcategory Samples allows the loading and unloading of sample racks. For every sample tube in the racks, there is the possibility to
assign a distinct identification number. This number is either read via bar-code scanner or entered manually. Additionally, one or more assays
can be assigned to every sample. After the starting of these assays/tests, it is indicated which samples are being processed.

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Figure 6-6: Sub category Samples

Rev. D
1 ... 10 Lanes of the loading bay for sample racks.
The display is divided into two parts:
 Upper part:
Click on the upper part (lane number and indicator) of an empty lane to load a sample rack in
this lane.
The upper part reflects also the rack status via LEDs below the lane (see chapter 4.2.5).
 Lower part:
Click on the lower part (sample rack) to select a rack. All samples will be shown in the table on
the right side.
Control Opens the control picklist and allow the selection of a control or the creation of a new control
definition. The bar-code of that control is assigned to the current (empty) SID field.
The Control button is disabled if the SID field is not empty.
Rack log The Rack Log field shows information about a loaded or selected sample rack.
 Loading errors
 Positions without bar-code or unreadable bar-code
Schedule Shows the Worklist tab to create or edit worklists for samples and controls (see chapter 6.3.1.1).
Table 6-7: Functions of the Samples sub category
The samples table shows all positions of the selected rack.

Column Description
! Shows an exclamation mark for high-priority samples (STAT).

Rev. D
Type Shows an empty cell for samples or a symbol for calibrators and controls:
Calibrators
Controls
SID Shows the sample ID, calibrator ID and control ID. The SID is read via bar-code scanner or
entered by operator (if bar-code not present or unreadable).
Notes:
The SID must be unique.
Two or more samples with the same SID are not allowed to load at the same time.
Use only the following characters:
 A - Z (a - z are converted to upper case for patient samples)
 0-9
 minus (-), dot (.), dollar sign ($), plus (+), percent sign (%), number sign (#), ampersand (&),
and equal (=).
A SID may be 3 to 17 characters long and may not contain spaces.
The SID of external calibrators begins with a predefined prefix character and contains the assay
abbreviation or article number.
Note:
The SID field is write protected, if any of the following applies:
 the rack is in "Error"
 the SID was read via bar-code (and accepted, i.e. not deleted because of duplication or illegal
character)
 the Control button was pressed for that SID at least once since the SID was recognized (i.e.
un-pressing that button does not allow typing, it's necessary to unload and reload the rack)
 either a workorder or a patient definition for that SID is present in the work-database (visible in
the sub category All of the main category Results, see chapter 6.4.1).

Rev. D
Symbol See table below.
Pending If assays areassigned to the sample: Shows all assays in status Placed or Failed for the sample.
In Process If assays are assigned to the sample: Shows all started assays in status Scheduled, Active or
Measured for the sample.
Table 6-8: Columns of the loaded samples table
Symbol Description
Loaded sample tube with known SID.
Loaded sample tube without bar-code or unreadable bar code,

or
no tube loaded.
The SID is empty.
Sample in process.
Sample off-line
(If a sample is off-line, unload it, check its status and reload again when OK.)
Table 6-9: Symbols
Light-Check must be loaded as ancillary reagent.

Any sample beginning with the special characterts (i.e. “#” or “$”) will be displayed as control or calibrator, no matter
if they will be treated as controls or calibrators or patient samples.

Rev. D
6.3.1.1 Worklist Tab – for patient samples
The Worklist tab enables the assignment between samples/controls and assays.
This section describes the assignment for patient samples.
Figure 6-7: Schedule display for patient samples
Samples list Shows all samples, calibrators, and controls which are present in the selected rack.

Rev. D
Column Description
It is not possible to create a worklist for selected samples and controls at the same time. Select samples separately
from controls.
Use the Lock button to use the multiple selection function.
Selection Group The Selection group allows the user to assign assays (tests) to one or more samples.
Assay Selection Assays are organized in groups. First it is necessary to choose the assay group. After that it is
in Group possible to select one or more assays.
 Colour:
 Shape:
 Solid: An integral for the assay is loaded.
 Broken with two stripes: An integral for the assay is not loaded.

Rev. D
Style Description
The assay is:
The assay is:
The assay is:
The assay is:
As soon as a test is started, the status changes to grey (unselected) and may be assigned again, even if the previous
test is still running
Demographics After having assigned assays to a sample, the Demographics group allows the user to enter or view detailed information about one selected
Group sample.

Rev. D
Sample ID Shows the sample ID (it is not possible to edit the sample ID).
Patient ID ID of the patient.
First name First name of the patient.
Initials Patient name initials.
Last name Family name of the patient.
Date of birth Date of birth of the patient.
Patient location Location of the patient.
Sender Name or code of the doctor. Allows selecting among a pre-
defined list of senders.
Sex Gender of the patient (Female, Male, or Unknown).
Table 6-14: Functions of the Demographics group
Detailed information of the Demographics group is only shown if the user has the access right “Patient Privilege”
(see chapter 6.7.5.1).
Dilutions Group
After having assigned assays to a sample, the Dilutions group allows the user to view and change dilution work orders for the corresponding
sample(s)/assay(s).
Selected Shows all selected assay(s).
Assay(s) Note: for combi assays, the combi fathers or the combi sons will be shown, depending on specific
assays.
Dilutions Shows all available dilution factors.
available for
Note: for combi assays, it may be not possible to select more than one dilution or undiluted.
Table 6-15: Functions of the Dilutions group

Rev. D
Replicates Group After having assigned assays to a sample, the Replicates group allows to define a number of replicates different from the default number
(indicated in the assay file), up to 20. The replicates can only be increased compared to the original value.
Column Description
Assay Name of the assay.
Replicates Number of replicates.
+ Increments the selected replicate number.
- Decrements the selected replicate number.
Table 6-16: Columns of the Replicates tab table
For combi assays, the system may show the replicates for the combi father of for the combi sons.
For combi assays, the system may run combi sons with the same number of replicates, independently from the
number of replicates defined.
6.3.1.2 Worklist Tab – for control samples
The Worklist tab enables the assignment between patient samples/controls and assays.
This section describes the assignment for controls.

Rev. D
Figure 6-8: Schedule display for controls

Rev. D
Samples list Shows all samples, calibrators, and controls which are present in the selected rack.
Column Description
It is not possible to create a worklist for selected samples and controls at the same time. Select samples separately
from controls.
Use the Lock button to use the multiple selection function.
Selection Group The Selection group allows the user to assign assays to one or more controls.

Rev. D
Assay Selection Assays that are available for that control are listed and can be selected.
 Colour:
 Shape:
 Solid: An integral for the assay is loaded.
 Broken with two stripes: An integral for the assay is not loaded.
Control Details The Control Details section shows the ControlID, ControlName, Control Lot and Expiration Date
for the selected control.
Style Description
The assay is:
The assay is:
The assay is:

Rev. D
The assay is:
As soon as a test is started, the status changes to grey (unselected) and may be assigned again, even if the previous
test is still running
Controls Group The Control group allows the user to select a particular reagent integral for the ordered control tests.
Control ID The control ID (i.e. the content of the bar-code).
Name The name of that control.
Lot The control lot number.
Expiry The control expiration date.
Assay The list of all assays that are have been assigned to that control in the Selection Group.
Note: select an assay to use the “This kit” option for that assay.
Range The expected concentration range in user units, separated with “…”.
Any kit/ This kit When "Any Kit" is selected, then the system will decide which integral to use to run the control.
When "This Kit" is selected, then it is possible to decide and pick an integral from the integral list
for the assay selected in the Assay list. The selected integral will be used to run that control.
If no integral is loaded, then "Any Kit" will be selected and "This Kit" is disabled.
Lot The lot number of each integral that is loaded for the selected assay.

Rev. D
Kit The kit number of each integral that is loaded for the selected assay.
Lane The lane number where each integral is loaded for the selected assay.
Tests The number of available determinations of each integral that is loaded for the selected assay.
Table 6-21: Functions of the “Control” group

Rev. D
6.3.2 Sub Category Ancillary

The sub category Ancillary shows the ancillary reagents that are currently loaded on the instrument.
Figure 6-9: Sub category Ancillary
Withdraw If it is necessary to remove the ancillary rack during a run, press this button to suspend the
pipettor access. Re-insert the used ancillaries as soon as possible.
Note: this could lead to test failures.

Rev. D
Table 6-22: Functions of the Ancillary sub category
Column Description
No Position of the ancillary reagent in the ancillary rack.
Name Name of the ancillary reagent.
Art No. Article number of the ancillary reagent (the colour represents the cap colour).
Lot No. Lot number of the ancillary reagent.
Serial No. Serial number of the ancillary reagent.
Exp. date Date and time when the ancillary reagent will expire.
Use by Onboard stability expiration date.
Volume Available liquid volume in the bottle.
Bound lots If there is an entry, it is possible to use integrals of the related assay with the reported lot number.
Table 6-23: Columns of the Ancillary sub category table
Off-line Status If an ancillary reagent is off-line, the descriptive text is displayed in grey.
Possible reasons:

Rev. D
6.3.3 Sub Category Reagents

The sub category Reagents can be divided into the Integrals group (in the lower part) showing the reagent integrals that are currently loaded
on the instrument, and into the Details group displaying detail information for any integral that is currently selected. Moreover, the sub
category Reagents provides a button to start a calibration, and a button to view the calibrations.
Figure 6-10: Sub category Reagents
See chapter 5.7.1.1 for details about the integral status display.

Rev. D
Calibrate Starts the calibration of a selected integral.
For assays that share calibration within a kit lot, this calibration will be available for all integrals of
that kit lot, no matter if loaded on-board or not. If calibration cannot be done (e.g. external
calibrators not loaded) a pop-up will inform. In this case no calibration will be created and no jobs
will be scheduled.
View Shows the calibration dialog and selects the valid calibration for the selected integral, if any.
Calibrations
Table 6-24: Functions of the Reagents sub category
A calibration cannot be started if any of the following occurs:

 another calibration is ongoing for the same integral
 another calibration is ongoing for another integral of the same lot (if that assay shares the Working Curve)
 the calibrators are external and not present onboard
 starters, calibrators, reagents are missing or empty
 starters or reagents are expired
Integrals Group Function Description

1 ... 25 Shows the integrals in the reagent loading bay lanes. Click on a loaded integral to show details
(see 'Group Details').
Table 6-25: Functions of the Integrals group

Rev. D
Details Group Function Description

Abbreviation Abbreviation of the assay.
Article No. Identification code of the selected integral that allows the LIAISON®XL system to associate the
integral to an assay.
Booked Tests Assigned but not started tests.
Calibration Status of the calibration (e.g. valid, not valid).
Status
Expiry Date Date and time when the reagent integral will expire. Note: this is the last day when that reagent
integral is allowed to be used.
Integral Layout Parameter that allows the LIAISON®XL system to identify the geometric characteristics of the
integral
Integral Status Status of the integral availability:
 Online: The integral is useable
 Offline: The integral cannot be used. The abbreviation is displayed in grey.
Possible reasons:
 The compatible assay protocol version is not loaded.
Kit No. Kit number of the reagent integral.
LIS alias Assay name on the LIS system.
Lot No. Lot number of the reagent integral.
Master Curve ID The ID of the calibration mastercurve used for this reagent integral.

Rev. D
On-board expiry Last date when the reagent integral can be used once it has been inserted on-board.
date
Original No. of Max. number of tests with a new integral.
tests
Remaining Remaining number of calibrations.
Calibrations
Remaining Remaining number of determinations for the selected integral.
Tests
The number is updated (decremented by one) as soon as the first aspiration event for a
determination occurs.
Table 6-26: Functions of the Details group
6.4 Main Category Results
The results of the sample tests or calibrations can be accessed via the main category Results as well as its several sub categories.
Sorting and See chapter 6.1.2

Searching
6.4.1 Sub Category All

The sub category All shows all entries of applied, started, and finished worklists. This sub category does not include calibrations and archived
results.
All items that are here can be found also in one or more of the sub categories: Worklist, Ongoing, Done, Failed or Controls.

Rev. D
Figure 6-11: Sub category All
Note: only entries in status “to do”, “placed”, “measured”, “done” and “failed” can be deleted.
Download Sends a "query all" message to a LIS system to initiate transmission of workorders. The
LIAISON®XL software shows an information dialog about the progress and errors.
Export Opens the Export display to export one or more entries to a file (see chapter 6.4.1.2).

Rev. D
New Opens the New Workorder display (see chapter 6.4.1.1)
Workorders
Table 6-27: Functions of the All sub category
Column Description
Measured Date Expected result date and time.
Status Shows the status of the entry (To do, Placed, Scheduled, Active, Measured, Done, Failed), see
below.
RLU Shows the raw results (in Relative Light Units).
Flags List of flags. For details about the flags see chapter 5.9.5.
Table 6-28: Standard columns of the All sub category
Result Status Status Description

Descriptions To do sample not present on board, not started yet
Placed sample present on board, not started yet
Scheduled starting soon
Active under performance
Measured completed but no dose received
Done successfully completed

Rev. D
Failed unsuccessfully completed
Table 6-29: Result status descriptions
In case a sample test is performed with two or more replicates and its status is “failed”, in case some replicates were
still to be started they may be restarted when a new routine will start. In this case, the entire sample test would
become “active” again.

Rev. D
6.4.1.1 New Workorders
This feature allows assigning assays to samples that are not loaded on the sample area.
Figure 6-12: New worklist display
Select Works as “Select/Unselect All” button, if the “Lock button” is set to “closed”.
All/Unselect All

Rev. D
Column Description
SID Shows the sample ID.
Note: the sample ID must be unique.
! Shows an exclamation mark for samples with STAT priority.
Table 6-31: Columns of the worklist table
Selection Tab Function Description

(Patient Assay Selection Assays are organized in groups. First it is necessary to choose the assay group. After that it is
Samples) in Group possible to select one or more assays.
Table 6-32: Functions of the Selection tab – Patient Samples
Selection Tab Function Description

(Control Assay Selection Assays that are available for that control are listed and can be selected.
Samples)
Control Details The Control Details section shows the ControlID, ControlName, Control Lot and Expiration Date
for the selected control.
Table 6-33: Functions of the Selection tab– Control Samples

Rev. D
It is necessary to assign at least an assay to at least one sample in order to have access to the other features of the
New Workorder display.
Demographics Function Description

Tab Sample ID Shows the sample ID (it is not possible to edit the sample ID).
Patient ID ID of the patient.
First Name First name of the patient.
Initials Patient name initials.
Last Name Family name of the patient.
Date of Birth Date of birth of the patient.
Patient Location Location of the patient.
Sender Name or code of the doctor. Allows to select among pre-defined list of senders.
Sex Gender of the patient (Female, Male, or Unknown).
Table 6-34: Functions of the Demographics tab
Detailed information of the Demographics group is only shown if the user has the access right “Patient Privilege”
(see chapter 6.7.5.1).
This tab is not available for control samples.
Dilutions Tab Function Description

Dilutions Shows all available dilution factors.
available for Note: for combi assays, the combi fathers or the combi sons will be shown, depending on specific
assays.

Rev. D
Selected Shows all selected assay(s).
Assay(s)
Table 6-35: Functions of the Dilutions tab
Replicates Tab Column Description

Replicates Number of replicates (1 to 20).
The replicates can only be increased compared to the original value.
+ Increments the selected replicate number.
- Decrements the selected replicate number.
Table 6-36: Columns of the Replicates tab table

Rev. D
6.4.1.2 Export
The Export display allows the exporting of one or more entries to a file.
Figure 6-13: Export display
Selection Group Function Description

All Records Exports all entries from the list.
Range Exports only entries with the specified conditions By, From, and To from the list.
Selected Exports only the selected entries from the list.
Records

Rev. D
Today's Exports only today's entries from the list.
Records
Export Settings Function Description

Group The selected items shall be exported either to a File.
Export To
Format Format (R&D or Text) in which results shall be exported.
Browse Opens the Select file dialog to select a folder. This folder name will be displayed in the field next
to the browse button.
If a file with the same name, extension and path is already present, the system will prompt a pop-
up asking if the file shall be overwritten or not.
Table 6-38: Functions of the Export Settings group
6.4.1.3 Result Details
The Result Details display is used to display all available information for a test.
Note: the layout may vary depending on the sample and assay characteristics.

Rev. D
Figure 6-14: Result Details display
Dilution Factor Dilution factor for the result (only for diluted tests).
Position in Rack Tube position in sample rack where the sample was aspirated from.
Rack lane Lane in the loading bay for sample racks where the sample rack was located.
Result Time The date/time when the result was measured or the expected result time if the test is Active.
chapter 6.4.1.
Table 6-39: Functions of the Result Details display
Depending on the used assay(s) the LIAISON®XL software will show the following details/values:

Rev. D
Regular assay Combi assay
Assay Yes Yes
Dilution Factor Yes List of the dilutions
for each combi son
Position in Yes Yes
Rack
Rack lane Yes Yes
Result Time Yes Calculation date/time
Sample ID Yes Yes
Status Yes Yes (combining the
status of the combi
sons)
Table 6-40: Shown details/values
Results Group Function Description

Result Calculated mean RLU result in user units, adjusted with the dilution factor.
(Average)
Below the mean result, the qualitative label is shown (only if defined for the used assay).
Result CV Shows the coefficient of variation (%) for the concentration result.
RLU (Average) Shows the mean RLU result.
RLU CV Shows the coefficient of variation (%) of the RLU result.
Table 6-41: Functions of the Result group

Rev. D
Description
Flag Summary List of all flags associated to this specific test, displayed as complete description. For details about
the flags see chapter 5.9.5.
Replicate List containing all replicate concentration results in user units (calculated and converted for each
Results single replicate RLU result).
Replicate RLU List containing all replicate RLU results.
Flags List of flags per replicate. For details about the flags see chapter 5.9.5.
Table 6-42: Columns of the Result group tables
Depending on the used assay(s) the LIAISON®XL software will show the following result details/values:
Result Dose, Qualitative Dose and/or
(Average) label Qualitative label
Result CV Yes No
RLU (Average) Yes No
RLU CV Yes No
Flag Summary Yes Yes
Replicate Yes No
Results
Replicate RLU Yes No
Flags Yes Yes
Table 6-43: Shown result details/values

Rev. D
Reagents Group Function Description
Ancillary on- Onboard stability expiration date for the ancillary reagent (if present).
board Note: ancillaries expire at midnight of the displayed date.
expiration date
Ancillary Kit number of the used ancillary reagent (if present).
reagents kit No.
Ancillary Lot number of the used ancillary reagent (if present).
reagents lot No.
Calibration Expiration date of the calibration used for result calculation.
expiration date Note: calibrations expire at midnight of the displayed date.
Calibration ID Unique identifier of the calibration used for result calculation.
Kit expiration Shelf expiration date of the used reagent integral.
date Note: kits expire at midnight of the displayed date.
Kit Lot No. Kit lot number of the used reagent integral.
Kit No. Kit number of the used reagent integral.
Kit on-board On-board stability expiration date of the used reagent integral.
expiration date Note: kits expire on-board at midnight of the displayed date.
Starter 1 lot No. Lot number of the used starter 1.
Table 6-44: Functions of the Reagents group
For Combi Assays, this tab contains all the combi sons information.

Rev. D
Process Group Function Description

Archived by Name of the user, who was logged in when the result was archived.
Archiving Time Date and time when the result was archived.
Calculated by* Name of the user, who was logged in when the result calculation was done.
Calculation Date and time when the result was calculated.
Time*
Processed by* Name of the user, who was logged in when the test was started.
Processing Date and time when the first aspiration occurred for the test.
Time*
Note: In case of two or more replicates this time refers to the first replicate.
Sent by Name of the user, who was logged in when the result was sent to LIS.
Sent to LIS Date and time when the result was sent to LIS.
STAT [y/n]* Shows "Y" for samples with STAT priority, “N” for normal priority samples.
Table 6-45: Functions of the Process group
For the fields marked with *, in case of Combi Assays, this tab contains the information for each combi son.
Patient Group Function Description

Date of birth Date of birth of the patient.
Sender Name or code of the doctor who will analyse the result.
Gender Gender of the patient (Female, Male, or Unknown).
Location Location of the sample provenience.
Name Patient name.

Rev. D
Pat.-ID Unique ID used to identify the patient on a LIS system.
Table 6-46: Functions of the Patient group

Rev. D
6.4.1.4 Delete Data
Figure 6-15: Delete Data display
All Records Deletes all entries from the list.
Range Deletes only entries with the specified conditions By, From,
and To from the list.
Selected Deletes all selected entries from the list.
Records
Today's Deletes all entries from this day from the list.
Records
Table 6-47: Functions of the Delete Data display

Rev. D
6.4.1.5 Select Filter
Figure 6-16: Select Filter display
All Records Selects all entries from the list.
Range Selects only entries with the specified conditions By, From,
and To from the list.
Today's Selects all entries from this day from the list.
Records
Table 6-48: Functions of the Select Filter display

Rev. D
6.4.2 Sub Category Worklist

The sub category Worklist shows only entries of applied and started tests with status To do and Placed.
Figure 6-17: Sub category Worklist

Rev. D
Download Sends a "query all" message to a LIS system to initiate transmission of workorders. The
LIAISON®XL software shows an information dialog about the progress and errors.
New Opens the New Workorder display (see chapter 6.4.1.1).
Workorders
Table 6-49: Functions of the Worklist sub category
Column Description
Status Shows the status of the entry (To do, Placed).
Table 6-50: Standard columns of the worklist table

Rev. D
6.4.3 Sub Category Ongoing

The sub category Ongoing shows only entries of started worklists with status Scheduled, Active, and Measured.
Figure 6-18: Sub category Ongoing
Abort Turns the test into “failed” and aborts the related processing (see chapter 6.4.1.5).

Rev. D
assay. For Combi Assays, all results for the same assay family are recalculated.
Note: do not use for “Active” tests.
Table 6-51: Functions of the Ongoing sub category
Column Description
Status Shows the status of the entry.
Table 6-52: Columns of the ongoing tests table

Rev. D
6.4.4 Sub Category Done

The sub category Done shows only entries of finished worklists with status Done.
Figure 6-19: Sub category Done
Archived.
Note: only entries in status “to do”, “placed”, “measured”, “done” and “failed” can be deleted.

Rev. D
Rerun Reschedules one or more entries, opening a selection display (see chapter 6.4.1.5).
Note: the entries will be set either to “placed” (if the sample is present on board) or to “to do” (if the
sample is not present on board).
Table 6-53: Functions of the Done sub category
Dose calculation will be done automatically by the system as soon as a valid calibration is availble, provided that all
the following conditions are met:
 the samples are successfully analyzed but without a dose (i.e. in status Measured),
 the samples were tested with the same kit (if the curve is not shared) or with a kit from the same lot (if the curve
is shared),
 the sample RLU results were obtained no more than 18 hours before the calibration.
Column Description
Measured Date Date and time when the test was measured.
Result Shows the dose result in user units. For some Combi Assays,
this may be replaced by a qualitative result.
Unit User units.

Rev. D
Qualitative Shows the qualitative label for the result (if defined for the
Label assay).
Table 6-54: Standard columns of the tests done table

Rev. D
6.4.5 Sub Category Archived

The sub category Archived shows only archived tests. The shown entries are not present in the sub category All.
Figure 6-20: Sub category Archived

Rev. D
Upload Tries to transmit the selected entries to the LIS system (see chapter 6.4.1.2). The LIAISON®XL
software shows an information dialog about the progress and errors.
Table 6-55: Functions of the Archived sub category
Column Description
Qualitative label Shows the qualitative label for the result (if defined for the
assay).
Table 6-56: Columns of the archived tests table
The system automatically performs back-up and clean-up of archived results. Such results can be retrieved via the
External Backup Viewer (see 6.11).

Rev. D
6.4.6 Sub Category Failed

The sub category Failed shows only entries of finished tests with status Failed.
Figure 6-21: Sub category Failed
Archived

Rev. D
Rerun Reschedules one or more entries, opening a selection display (see chapter 6.4.1.5).
Note: the entries will be set either to “placed” (if the sample is present on board) or to “to do” (if the
sample is not present on board).
Table 6-57: Functions of the Failed sub category
Column Description
Table 6-58: Standard columns of the failed tests table

Rev. D
6.4.7 Sub Category Calibrations

The sub category Calibrations shows only calibration entries (in any possible status).
Figure 6-22: Sub category Calibrations
Details Opens the Calibration Details display for the selected entry (see chapter 6.4.7.1).
Disable Disables one or more selected calibration entries, i.e. changes the status of all "valid" or "created"
calibrations among the selected ones to "not used".
Note: all related integrals will need to be recalibrated if used for new testing.

Rev. D
View Reagents Opens the sub category Reagents (see chapter 6.3.3).
Table 6-59: Functions of the Calibrations sub category
Column Description
Calibration ID Internal unique ID assigned to this calibration record. This ID will be not reused even after the
calibration has been deleted.
Reagent Lot Lot number of the used reagent integral.
Kit Number Kit number of the used reagent integral.
Measured Date The date and time when the calibration RLU results were measured.
Expiry Date Date when the calibration will expire.
Note: calibrations expire at midnight of the displayed date.
Status Shows the status of the entry (Created, Failed, Invalid, Valid, Expired, NotUsed), see below.
User Name of the user, who was logged in when the calibration was started.
Table 6-60: Columns of the calibrations table
Calibration Status Description

Status Created The Calibration is just created, not yet measured.
Descriptions
Failed One of the calibrators is failed.
Note: a failed calibrator replicate out of three could be treated
as outlier, and the calibration could result as valid.

Rev. D
Invalid The calibrators were processed, but the calibration result has
been rejected by the software.
Valid The Calibration was successfully measured and calculated.
Expired The Calibration was valid but the expiration period is over.
NotUsed The status "not used" arises in any of the following situations:
 when a newer calibration is validated;
 when the calibration is manually disabled via the
button " Disable";
 when the calibration is automatically disabled because
of a starter lot change.
Table 6-61: Calibration status descriptions
6.4.7.1 Calibration Details
All calibration values are not editable.

Rev. D
Figure 6-23: Calibration details display
Assay Assay abbreviation.
Calibration ID Internal unique ID assigned to this calibration record. This ID will be not reused even after the
calibration has been deleted.
Expiry Date Date when the calibration will expire.
Lot No. Lot number of the used reagent integral.
Status Shows the status of the entry (Created, Failed, Invalid, Valid, Expired, NotUsed), see chapter
6.4.7.

Rev. D

Backfit (Dose) Displays the calibrator doses calculated on the new working curve.
CV% (RLU) Displays the percent variation coefficient for RLU results of calibrator 1 or 2.
Deviation% Displays the percent deviation from the nominal RLU value for calibrator 1 or 2. If the mean RLU is
(RLU) out of the tolerance range, the mean RLU value and the exceeded limit are shown in red . In this
case, the calibration will be invalid.
Expected Displays the nominal values of the dose of calibrator 1 or 2.
(Dose)
MaxCV% (RLU) Displays the assay max RLU CV% for calibrator 1 or 2.
Mean (RLU) Displays the mean RLU value for calibrator 1 or 2. If the mean RLU is out of the tolerance range,
the mean RLU value and the exceeded limit are shown in red . In this case, the calibration will be
invalid.
Range The allowed range for the Ratio field of the Geometric Curve Check, when defined.
(Geometric
Curve Check)
Ratio The ratio between the RLU values of two given points of the working curve, when defined a range
(Geometric is defined.
Curve Check)
The range limits are shown in red if the ratio exceeds the tolerance range. In this case, the
calibration will be invalid.
Target (RLU) Shows the nominal values of the RLU results of calibrator 1 or 2 (if applicable).
Tolerances% The tolerance range for RLU values of calibrator 1 or 2.
(RLU)
Table 6-63: Functions of the Results group
Graphics Group The Graphics group shows the plot of the actual working curve (black) and the acceptance limits derived from the master curve (green). The
concentration values are reported in user units. The graphic is available only for quantitative calibrations.

Rev. D
The software automatically adjusts the X and Y axis, in order to fit the obtained working curve.
Graphic Displays the obtained working curve.
X-Axis
 Concentration (unit: in user unit depends on assay settings; scale: logarithmic)
Y-Axis
 RLU (scale: linear)
User Unit User unit.
Master Curve ID The ID of the master curve used for this calibration.
Table 6-64: Functions of the Graphics group
Tracebility Group Function Description

Ancillary lot No. Lot number of the used ancillary reagent.
Only visible if there are ancilliaries in the reagent setup.
Ancillary kit No. Kit number of the used ancillary reagent.
Only visible if there are ancilliaries in the reagent setup.
Expiry Date (Kit) Shelf expiration date of the used reagent integral.
Flag list List of relevant result flags obtained for this calibration. For details about the flags see chapter
5.9.5.
No. (Kit) Kit number of the used reagent integral.
On-board On board stability: Last date when the reagent integral can be used once it has been inserted on-
Expiry Date (Kit) board.
Note: reagents expire at midnight of the displayed date.

Rev. D
Operator Name of the user, who was logged in when the calibration was started.
Run date/time The date and time when the calibration RLUs were measured.
Starter lot No. Lot number of the used starter 1 or 2.
Table 6-65: Functions of the Traceability group

Rev. D
6.4.8 Sub Category Controls

The sub category Controls shows the results of the controls.
Figure 6-24: Sub category Controls

Rev. D
Table 6-66: Functions of the Controls sub category
Column Description
Range The manufacturer range for the assigned assay.
Control Lot The lot number of the control.
Number
Result The dose result of the control.
Unit User units.
Result Date Result date and time.
Table 6-67: Standard columns of the controls table
6.4.8.1 Control Details
The Result Details display is used to display all available information for a control.

Rev. D
Figure 6-25: Result Details display
Control ID SID of the control
Control Lot. No. Lot number of the used control.
Control name Name of the control.
Expiry Date Shelf expiration date of the control.
Note: controls expire at midnight of the displayed date.
Manufacturer The low and high limits of this control for the assigned assay, in user units.
range
Position in Rack Tube position in sample rack where the control was aspirated from.
Rack lane Lane in the sample area where the sample rack was loaded when result was obtained.
Result Date The date when the result was measured or the expected result date if the test is Active. For
Combi Assays, it is the calculation date.

Rev. D
Result Time The time when the result was measured or the expected result time if the test is Active. For
Combi Assays, it is the calculation time.
chapter 6.4.1. For Combi Assays, this combines the status of the combi sons.
User Range The low and high limit of the reference range for this control, in user unit.
Table 6-68: Functions of the Result Details display

Result Calculated mean RLU result in user defined units.
(Average)
Below the mean result, the qualitative label is shown (only if defined for the used assay).
Result CV Shows the coefficient of variation (%) for the concentration result.
RLU (Average) Shows the mean RLU result.
RLU CV Shows the coefficient of variation (%) of the RLU result.
Table 6-69: Functions of the Result group
Column Description
Flag Summary List of all flags associated to this specific control, displayed as complete description. For details
about the flags see chapter 5.9.5.
Replicate List containing all replicate concentration results in user units (calculated and converted for each
Results single replicate RLU result).
Replicate RLU List containing all replicate RLU results.
Flags List of flags per replicate. For details about the flags see chapter 5.9.5.
Table 6-70: Columns of the Results group tables

Rev. D
Depending on the used assay(s) the LIAISON®XL software will show the following result details/values:
Result Dose Dose
(Average)
Result CV Yes No
RLU (Average) Yes No
RLU CV Yes No
Flag Summary Yes Yes
Replicate Yes No
Results
Replicate RLU Yes No
Flags Yes Yes
Table 6-71: Shown result details/values
Reagents Group Function Description

Ancillary on- Onboard stability expiration date.
board Note: ancillaries expire at midnight of the displayed date.
expiration date
Ancillary Kit number of the used reagent integral.
reagents kit No.
Ancillary Reagent lot number of the used ancillary reagents.
reagents lot No.
Calibration Expiration date of the calibration used for result calculation.
expiration date Note: calibrations expire at midnight of the displayed date.

Rev. D
Calibration ID Unique ID of the calibration used for result calculation.
Kit expiration Shelf expiration date of the used reagent integral.
date Note: integrals expire at midnight of the displayed date.
Kit Lot No. Lot number of the used reagent integral.
Kit No. Kit number of the used reagent integral.
Kit on-board On-board stability expiration date of the used reagent integral.
expiration date Note: integrals expire on-board at midnight of the displayed date.
Table 6-72: Functions of the Reagents group
For Combi Assays, this tab contains all the combi sons information.
Process Group Function Description

Archived by Name of the user, who was logged in when the result was archived.
Archiving Time Date and time when the result was archived or empty as long as it is not archived.
Calculated by Name of the user, who was logged in when the result calculation was done.
Calculation Date and time when the result was calculated or recalculated.
Time
Processed by Name of the user, who was logged in when the control was started.
Processing Date and time when the first aspiration occurred for the job.
Time
Note: In case of two or more replicates this time refers to the first replicate.
Table 6-73: Functions of the Process group

Rev. D
6.5 Main Category Events
In the main category Events, all messages and errors occurred are listed according to their type.
When the main category Events is opened, then that sub category will be opened too, which has new content in it, i.e.:
1. the sub category Messages will be opened as long as there are unacknowledged messages,
2. the sub category Event Log will be opened.
In case of any fatal error a pop up is immediately and automatically displayed.
Sorting and See chapter 6.1.2

Searching
6.5.1 Sub Category Event Log

The sub category Event Log lists in real time, any event that occurs on the system. This includes errors, log in data, result failures and other
information that may help troubleshooting activities.

Rev. D
Figure 6-26: Sub category Event Log
Details Shows details about the selected entry.
Select All Select all event log entries.
Standard buttons For standard buttons (e.g. arrow buttons, lock, Print) see
chapter 6.1.
Table 6-74: Functions of the Event Log sub category

Rev. D
Column Description
Message Text Shows the event message.
Date Time Shows the date and time when the event occurred.
Code Shows the code of the message.
Severity Shows the level of the event (Message, Critical event,
Warning).
Origin Shows the name of the module which originated the event.
Table 6-75: Columns of the event log table
When the Event Log sub category is opened, the event log table is sorted chronologically in descending order. The sort order can be
changed by clicking onto the headline of a column. Then the content of this column will be used as sort criterion. The sort direction can be
toggled between ascending and descending by clicking onto this headline repeatedly.
Events are described in chapter 9.1.

Rev. D
6.5.2 Sub Category Messages

The sub category Messages shows all messages that have not yet been acknowledged. Messages are special events containing information
that shall be acknowledged by the user.
Every result flag will be shown first as an error message (see chapter 5.9.5).
Figure 6-27: Sub category Messages

Rev. D
Acknowledge To accept a selected message by clicking on the Acknowledge button. The message will be
removed from the list, but it is still available in the sub category Event Log.
Details Opens the Details Event display for the selected message.
Mute Alarm Switches off the instrument beeper.
Control Displays the sub category Controls. The button is only enabled if there are a “control out of range”
events in the message list or upon login if such messages are still present. The button is disabled
after it is pressed.
Select All To select all message entries.

Table 6-76: Functions of the Messages sub category
Column Description
Message Text Shows the event message.
Date Time Shows the date and time when the event occurred.
Code Shows the code of the message.
Severity Shows the level of the event (Message, Critical, Warning).
Table 6-77: Columns of the messages table
When the Messages sub category is opened, the messages table is sorted chronologically in descending order. The sort order can be
changed by clicking onto the headline of a column. Then the content of this column will be used as sort criterion. The sort direction can be
toggled between ascending and descending by clicking onto this headline repeatedly.
Error messages are described in chapter 9.1.

Rev. D
If the error re-occurs, please call local support.
Every message triggers the audible alarm to beep. The emitted noise depends on the severity of the error. Some
errors trigger also the visible alarm, if provided.
For errors that trigger the alarms repeteadly on, use the button Mute Alarm to turn them off. Acknowledging a
message does not turn the alarms off.
Pressing the Help button when the Details Event dialog is open will bring directly to the User Manual description for
that message.

Rev. D
6.5.3 Fatal Errors
Fatal errors are a particular category of error messages that are given if the routine has been interrupted and cannot be recovered. The error
message will be shown as soon as possible.
Figure 6-28: Error Message

Rev. D
6.6 Main Category Definitions
In the main category Definitions, its subcategories are; information on assays, controls, assay groups, rerun rules and profiles which can be
accessed . Additionally, there are several editing possibilities available.
6.6.1 Sub Category Assay

In the subcategory Assay, all assays available in the LIAISON®XL system at that moment are indicated. In the table, the assay names and
the article numbers and the assignment to an assay group are indicated. There is the possibility to access further information on the individual
assays.
For loading new assays into the system, an import function is available.

Rev. D
Figure 6-29: Sub category Assay
Details Shows details about a selected assay (see chapter 6.6.1.1).
Import Imports one or more assays from a file. This function is only available if the instrument is not
running.
Table 6-78: Functions of the Assay sub category

Rev. D
If an already existing assay is imported into the LIAISON®XL system, only those parameters of that assay will be
overwritten which are not user editable. Parameters, which are user editable, will be maintained, unless differently
explained by the system.
Column Description
Assay Assay name.
LIS Alias Assay name on the LIS system.
Revision Revision number of the assay.
Article Number Article number of the assay.
Group Organisation groups.
Table 6-79: Columns of the assays table
6.6.1.1 Assay Details
Figure 6-30: Details display

Rev. D
®
If an already existing assay is imported into the LIAISON XL system, only those parameters of that assay will be
overwritten, which are not user editable. Parameters, which are user editable, will be maintained.
Abbreviation Abbreviation property of the assay.
Article No. Article number of the assay.
Country Code Country code of the assay.
Creation Date Creation date of the assay.
LIS Alias Assay name on the LIS system.
Name Assay name.
Priority Scheduling priority (1 to 200) of the assay. Assays with the highest priority number (starting from
200) will be processed before assays with lower priority number (up to 1) for samples within a rack
(in case of Random Access mode) or within the entire sample area (in case of Batch mode).
Revision Revision number of the assay. Only integrals compatible with this revision can be used.
Sample Number of replicates for patient and control samples, up to 20.
Replicates
It is only allowed to increase the number of replicates, and after to decrease but no lower than the
default number (provided in the assay file).
Changing an assay priority would trigger changes in the order of assay execution, with the possible consequence of
throughput changes.

Rev. D
For combi assays, the system may run combi sons with the same number of replicates, independently from the
number of replicates defined.
Column Description
Groups Organization groups. List of all groups, which the assay belongs to.
Table 6-81: Columns of the details table
Calibration Group Function Description

Calibration Shows the validity period for calibrations.
Interval
Calibrator Shows the number of replicates to be run for calibrations.
Replicates
Calibration Yes:
shared within
kit lot  The calibration is valid for kit lot (“Shared Working Curve” approach).
No:
 The calibration is valid for the specific integral (“Not Shared Working Curve” approach).
If the default setting is No, it is not allowed to select Yes.
Table 6-82: Functions of the Calibration group

Rev. D
Calculation Function Description
Group Conversion factor between default unit and user defined unit.
Conversion
Factor
Example:
 Default unit: g/l
 User defined unit: mg/l
 Conversion factor: 1000
Default Unit Default unit.
Digits Shows the number of significant digits to be reported for the result and related ranges/thresholds.
Result Aspect Selection for the result transmission to the host (Dose, Label, Both)
for host
transmission
Send replicates Selection for the result transmission of the replicates to the host (Yes, No)
to host
User Unit User defined unit (e.g. mg/l). See Conversion Factor above.
Table 6-83: Functions of the Calculation group
Changes of the user unit and the conversion factor affects only new results.
All dose-related ranges are shown according to the user units, as the software automatically converts them.
It is necessary to completely save the changed user unit and the conversion factor and close the Assay detail page,
before changing the Normal Range. Changing the Normal Range before closing the Assay detail page may result in
a successive update of the Normal Range performed automatically by the system, based on the new user unit and
the conversion factor.

Rev. D
Ranges Group Function Description

User Unit User defined unit.
Normal Range The low and high limit of the normal range for the assay, in user defined unit and adjusted for the
dilution factor. When a result falls into this range, it will be provided with the corresponding flag.
The low value must be smaller than the high value. The low limit is included and the high limit is
excluded.
If a limit field is left empty the LIAISON®XL software will handle this as "do not care". This allows
to define one-sided ranges ("0 ... X" or "Y .. +inifinity") as well as “0 .. +infinity”.
Assay Range Shows the low and high limit of the assay range for the assay, in user defined unit and not
adjusted for the dilution factor. When a result falls into this range, it will be provided with the
corresponding flag; it will be shown as “<” followed by the low limit or “>” followed by the high limit.
The low limit is included and the high limit is excluded.
to define one-sided ranges ("0 ... X" or "Y .. +inifinity") as well as “0 .. +infinity”.
Overdilution Shows the overdilution point for that assay, in user defined unit. If results get lower than the
Point overdilution point it will be considered not valid and therefore the results will not reported (i.e. dose
not given).
Font Opens the Select Font display to pick up a font to be assigned to the currently selected qualitative
label.
Color Opens the Select Color dialog to pick up a color to be assigned to the currently selected
qualitative label.
Table 6-84: Functions of the Ranges group

Rev. D
Column Description
Range, Low The low and high limit for that corresponding qualitative range, in user defined units, for up to 5
Limit and qualitative settings.
Range, High
The low limit is included and the high limit is excluded.
Limit,
to define one-sided ranges ("0 ... X" or "Y .. +inifinity") as well as “0.. +infinity”.
Example:
Low: empty; high: 1; Label: neg
Low: 1; high: 10; Label: eq
Low: 10; high: empty; Label: ^POS
Label The qualitative label to be applied to results within this range. That label is displayed using the
dedicated font and color defined for that label.
Table 6-85: Columns of the ranges table
Dilutions Group Shows all (0.. max. 9) sample dilution factors, which are defined for the assay.
Delete Deletes the currently selected sample dilution from the list of sample dilutions for the assay.
A dilution can not be deleted if it is used in a rerun rule or in an existing worklist entry (To do,
Placed, In process or Measured).
Table 6-86: Functions of the Dilutions group
Column Description
Factor Shows the dilution ratio as integer. The range is from 1 to 2500 and has to be unique.
No. Shows the number of the factor.
Table 6-87: Columns of the dilutions table

Rev. D
Audit Trails Shows the history of changes of the:

Group  User unit/Conversion factor
 Sample replicates
 Normal range
 Calibration shared within kit lot
If the user changes one value out of those, or imports a new assay revision, then the Audit Trails group is activated and the user is prompted
to type in a reason for the change. The audit trails are maintained after a new assay revision was imported.
Column Description
User Name of the user, who changed an entry.
Date Shows the date when the change was made.
Item Shows the changed field/function.
From Original value.
To New value.
Reason Shows the reason of change.
Table 6-88: Columns of the dilutions table

Rev. D
6.6.2 Sub Category Control

In the subcategory Control, detailed information on the control definitions can be accessed.
Figure 6-31: Sub category Control
Add Adds a new control definition (see chapter 6.6.2.2).
Delete Deletes one or more selected control definitions (see chapter 6.4.1.4).
Details Shows details about a selected control definition (see chapter 6.6.2.1).

Rev. D
Export Exports a control definition to a file.
Import Imports a control definition from a file.
Scan Enables to scan a bar-code of a control with a hand bar-code scanner, see chapter 5.6.3. The
control will be added to the list.
Standard buttons For standard buttons (e.g. arrow buttons, lock, Print), see chapter 6.1.
Table 6-89: Functions of the Control sub category
Column Description
Name Shows the name of a control definition.
Barcode Shows the bar-code of the control reagents.
Lot Number Shows the Lot number of the control reagents.
Expiry Date Shows the expiration day of the control reagents.
Manufacturer Shows the manufacturer of the control reagents.
Assays Shows all aligned assays.
Table 6-90: Columns of the controls table
6.6.2.1 Control Details
The Control Details display shows detailed information about a control definition. Several fields can be edited.
Controls must not be defined for logical combi assays: they could not result in a numerical result, therefore controls
for logical combi assays are not supported by the system..

Rev. D
Figure 6-32: Control Details display
Add Opens the Control Data Dialog to add a new assay control.
Assay Selection Shows all aligned assays.
group
Barcode-ID Bar-code of the control.
Delete Deletes the currently selected assay data control definition from the database.
Expiry Date Expiration day of the control.
Lot Number Lot number of the control.
Manufacturer Manufacturer of the control.
Name Name of a control definition. The control Name in combination with the Lot Number must be
unique. Any sequence of alphanumeric characters (spaces and "-" are allowed) can be entered as
a control Name.

Rev. D
The data above can be read with an external reader from data control chart via 2-dimensional barcode.
6.6.2.2 Add Controls
Enables user to add a new control to the LIAISON®XL system.

Add Opens the Control Data Dialog to add a new assay control.
Assay Selection Shows all aligned assays.
group
Barcode-ID Bar-code of the control.
Delete Deletes the currently selected assay data control definition from the database.
Expiry Date Expiration day of the control.
Lot Number Lot number of the control.
Manufacturer Manufacturer of the control.
Name Name of a control definition. The control Name in combination with the Lot Number must be
unique. Any sequence of alphanumeric characters (spaces and "-" are allowed) can be entered as
a control Name.

Rev. D
Control Data Column Description
Group Defines, when the control definition must be performed.
Frequency
 After Calibrations
 Every X Hours
 Every Y Hours
 Integral Begin
 Ancillary Begin
 With STAT
Manufacturer The low and high limit of this control definition in user defined units (result is expected to be in this
Range range).
Target CV Contains the target value for the variation coefficient.
Type To define whether this is a Accuracy or a Precision control.
User Range The low and high limit of the reference range for this control, in user unit.
Table 6-93: Columns of the controls table
The Manufacturer Range can be read with an external reader from data control chart via 2-dimensional barcode.
For assays that have an assay range lower limit defined, a control range lower limit set to 0 would cause the flags
QL/UL to be reported whenever the result exceeds the assay range lower limit. Otherwise, a control range lower limit
left empty does not cause a flag.

Rev. D
6.6.3 Sub Category Groups

In the subcategory Groups, there is the possibility to include assays in groups. It is necessary to include an assay in a group to be able to
assign manually a patient sample to such assay.
Figure 6-33: Sub category Groups

Rev. D
Add Shows the Group Details display to add a new assay group (see chapter 6.6.3.1).
Delete Deletes one or more selected assay groups (see chapter 6.4.1.4).
Details Shows the Group Details display to show or edit the selected assay group (see chapter 6.6.3.1).
Export Exports a group definition to a file. Note: such operation may be time consuming.
Import Imports a group definition from a file. Note: such operation may be time consuming.
Up / Down Moves the currently selected group one line up or down.
Table 6-94: Functions of the Groups sub category
Column Description
Group Name Shows the assay group name.
Assays Shows all assigned assays.
Table 6-95: Columns of the groups table

Rev. D
6.6.3.1 Group Details: Details or Add
Figure 6-34: Group Details display
Assay Group The Assay Group shows the name of all assigned assays (up to 15).
Assay Selection Shows all available assays (unless they are prevented by usage). Click on the assay button to
assign it to the group.
Group Name Name of the assay group. The assay group name must be unique. Any sequence of alphanumeric
characters (spaces and "-" are allowed) can be entered as an assay group name

Rev. D
6.6.4 Sub Category Rerun Matrix

In the subcategory Rerun Matrix, there is the possibility to indicate, modify or generate the rerun rules.
Figure 6-35: Sub category Rerun Matrix

Rev. D
Add Shows the Rerun Rule Details display to add a new rerun rule (see chapter 6.6.4.1).
Delete Deletes one or more selected rerun rules (see chapter 6.4.1.4).
Details Shows the Rerun Rule Details display to show or edit the selected rerun rule (see chapter
6.6.4.1).
Export Exports one or more selected rerun rules to a file.
Import Imports one or more selected rerun rules from a file.
Table 6-97: Functions of the Rerun Matrix sub category
Column Description
Rerun Rule Shows the name of the rerun rules. The rerun rule name must be unique.
Name
Assays Shows the assay.
Assay To Run Shows the assay that is launched if the conditions are satisfied.
Dilution Dilution factor assigned to the assay.
Status Shows the status (Enabled or Disabled) of the rerun rule.
Table 6-98: Columns of the rerun matrix table

Rev. D
6.6.4.1 Rerun Rule Details: Details or Add
Figure 6-36: Rerun Rule Details display
Enabled / Allows disabling a rerun rule without deleting it.
Disabled
Name Name of the rerun rule. The rerun rule name must be unique and not longer than 20 characters.
Any sequence of alphanumeric characters (spaces are allowed) can be entered as a rerun rule
name.

Rev. D
Conditions Group Function Description

1st Assay Mandatory assay for the rerun rule.
Assay 1
Click on the button to open a selection dialog. Pick up an assay in this dialog.
Range 1
Specifies the low and high limit of the condition range. If empty the LIAISON®XL software will treat
this as “do not care” and consider this condition as always true.
2nd Assay Optional assay for the rerun rule.
Assay 2
Click on the button to open a selection dialog. Pick up an assay in this dialog.
Range 2
Specifies the low and high limit of the condition range. If empty the LIAISON®XL software will treat
this as “do not care” and consider this condition as always true.
And/Or Evaluation condition:
 And: Range 1 and range 2 must be fulfilled (both).
 Or: Range 1 or range 2 must be fulfilled (only one).
Table 6-100: Functions of the Conditions group
Actions Group Function Description

Dilution Factor Dilution factor assigned to the assay.
Priority Whether the rerun rule is to be scheduled with Normal or STAT priority.
Repetitions Defines the number of times that assay shall be run for that sample.

Rev. D
Assay Click on the button to open a selection dialog. Pick up an assay (never run assays are excluded)
in this dialog.
Table 6-101: Functions of the Actions group
Tests, that have been started via a Rerun Rule, will not be evaluated against any Rerun Rule.
Samples, that have been erroneously removed while they were displayed as active, may not trigger a Rerun Rule
evaluation even after reloading.
The Rerun Rules are ignored by the system in case that the LAS option is ON.

Rev. D
6.6.5 Sub Category Profiles

In the subcategory Profile, there is the possibility to arrange several assays as a profile. If the user assigns assays to samples, they can
select a profile instead of all affected assays. In this way it is possible to simplify recurrently test arrangements.
Figure 6-37: Sub category Profiles

Rev. D
Add Shows the Profile Details display to add a new profile (see chapter 6.6.5.1).
Delete Deletes one or more selected profiles (see chapter 6.4.1.4).
Details Shows the Profile Details display to show or edit the selected profile (see chapter 6.6.5.1).
Table 6-102: Functions of the Profiles sub category
Column Description
Profile Name Shows the name of the profile.
Assays Shows all assigned assays.
Table 6-103: Columns of the profiles table
6.6.5.1 Profile Details: Details or Add
Figure 6-38: Profile Details display

Rev. D
Assay Selection Shows all available assays. Click on the assay button to assign it to the profile.
Assay Profile The Assay Profile group shows details about the profile.
Profile List
The list shows the name of all assigned assays.
Profile Name Name of the profile. The assay profile name must be unique. Any sequence of alphanumeric
characters (spaces and "-" are allowed) can be entered as a profile name.

Rev. D
6.6.6 Sub Category Sender

In the subcategory Sender, it is possible to store information about the sample source.
Figure 6-39: Sub category Sender
Add Shows the Sender Details display to add a new sender.
Delete Deletes one or more selected sender (see chapter 6.4.1.4).
Details Shows the Sender Details display to show or edit the selected sender.

Rev. D
Table 6-105: Functions of the Sender sub category
Column Description
Code Code of the doctor.
Name Name of the doctor.
Section Department
City Address of the doctor - city.
Table 6-106: Columns of the sender table
6.6.6.1 Sender Details: Details or Add
Figure 6-40: Sender Details display

Rev. D
City Address of the doctor - city.
Code Code of the doctor.
Comment Comment to the entry.
Name Name of the doctor.
Phone Telephone number of the doctor.
Section Department
Street Address of the doctor - street.

Rev. D
6.7 Main Category System
The main category System allows the user to adapt the LIAISON®XL system to their specific circumstances and needs.
6.7.1 Sub Category Account

The subcategory Account can be used to change the user’s own password or to log off the LIAISON®XL software.
Figure 6-41: Sub category Account

Rev. D
Current User Function Description
Details Group Shows the users allocated access rights (see chapter 6.7.5.1).
Privilege Level
Apply Applies the change of the password.
Confirm Field to re-enter the new password.
Password
Logout Allows current user to log off.
If the user logs out while the instrument is running, the run will continue. User intervention on the
hardware side (covers, containers...) will be traced, but not associated with a specific user.
Name Shows the user name.
New Password Field for the new password.
Any alphanumeric chain of 8 to 20 characters can be used as password. The password is case
sensitive.
Old Password Field for the current password.
Table 6-108: Functions of the Current User Details group

Rev. D
6.7.2 Sub Category Applications

The subcategory Applications can be used to start additional applications.
Figure 6-42: Sub category Applications

Rev. D
Viewer Starts the external backup viewer application (see chapter 6.11).
QC Starts the long term quality control (QC) application (see chapter7).
Table 6-109: Functions of the Applications sub category

Rev. D
6.7.3 Sub Category Backup

The sub category Backup provides the option to make a backup of the LIAISON®XL system files (e.g. database and settings files).
Figure 6-43: Sub category Backup
The backup function is only available while the LIAISON®XL system is in Standby , Ready, Halted or Not initialized
status, otherwise all controls and buttons are disabled.

Rev. D
Information line Shows the status of the LIAISON®XL system.
Additionally the software shows a second line with information about the creation or copying
progress (e.g. Backup finished with success).
New Backup Allows user to create a new backup.
Create 1. Select the backup type:
 Access_Rights: Saves only files to determine the defined accounts and defined
 LIS: Saves all files generated by host communication and related settings
 Database: Saves all databases for results, events, and system characteristics
 Maintenance: Saves all files related to maintenance definition
 QC: Saves files to exchange data between main software and QC Software
 All: Saves all files relevant for the software
 Troubleshooting: Saves a selection of files useful for a general troubleshooting
 Autobackup: not to be used (system driven backup)
 AllStoreLogs: Saves all the files useful for certain specific errors of the system
 AllLogArchives: Saves all older log files
 Press on the Create button.
Select a Backup Allows user to copy a backup file on an external storage device, or CD or DVD.
to Copy
1. Select the external storage device, or CD or DVD in the Select a Backup to Copy list.
Copy
2. Select an existing backup file in the backup file table.
3. Press on the Copy button. In case of CD or DVD, it must have been formatted via the Format
CD/DVD button before pressing the Copy button.
Select a Backup Allows user to prepare a CD or a DVD to be ready for file copy.
to Copy
A CD or a DVD can be formatted using such button on any LIAISON®XL system.
Format CD/DVD

Rev. D
Table 6-110: Functions of the Backup sub category
Column Description
No. Number of the backup.
Name Name of the backup file.
Size Needed storage space on external device.
Table 6-111: Columns of the backup table

Rev. D
6.7.4 Sub Category LIS/LAS
The sub category LIS/LAS is used to configure the connection between the LIAISON®XL system and a Laboratory Information System (LIS).
The connection between the LIAISON®XL system and a LIS enables the interchange of test requests and test results, while the connection
between the LIAISON®XL system and a LAS enables the instrument to pipette samples automatically routed from an external system.
Laboratory Information System (LIS) is often called a Host.
Note: For details about the interface protocol ask local service support.
Figure 6-44: Sub category LIS/LAS - LIS tab

Rev. D
LIS Tab The LIS tab is to specify the interface for exchanging information between the LIAISON®XL instrument and a LIS.
Apply Stores all changes.
Bad Frame Overwrites the ASTM1381 'Bad Frame Send <NAK> Timer’
Send <NAK>
Default: 30; Range: 30 - 99999
Timer
Baudrate Specifies the speed (baud rate) used for transmissions between the LIAISON®XL and the host.
Overwrites the ASTM1381 requirements.
Default is 9600; Values: 19200, 9600, 4800, 2400, or 1200
Busy Timer Overwrites the ASTM1381 'Busy Timer’
COM Port This field specifies the serial port used for host transmissions.
Default: 2; Range: 2, 3, 4.
Data Bits Defines the number of bits per character.
Overwrites the ASTM1381 requirements.
Default: 8; Values: 7 or 8
Date Template Must not be changed.
Delimiter Delimiters are used for outgoing messages. Incoming messages may have different delimiters.
| is the default Field delimiter
\ is the default Repeat delimiter
^ is the default Component delimiter
& is the default Escape delimiter

Rev. D
Enable Sends additional information (reagent kit no., reagent expiration date, reagent lot no., calibration
Manufacturer ID, sample rack lane, sample position in the rack) to the host.
record
Host ID Allows user to assign a name to the host.
Default is blank
Instrument ID Allows user to assign a unique instrument ID to the LIAISON®XL system. It is used to verify that a
transmission is intended for this instrument.
Default will be the instrument ID entered at installation.
LIS module Allows the LIS transmission (Yes, No).
Parity A parity bit is a bit that is added to ensure that the number of bits with value of one in a given set
of bits is always even or odd. Parity bits are used as the simplest error detecting code.
Default: None; Values: Even, Odd or None
Record ASTM A protocol file of data transmitted on ASTM1381 level can be recorded.
1381
Default: N; Values: Y or N
Record ASTM A protocol file of data transmitted on ASTM1394 level can be recorded.
1394
Default: Y; Values: Y or N
Reload Becomes enabled only when changes are made to that dialog. Reloads the current settings from
file to revoke all changes made (since last changes were applied). This makes the button disabled
again.
Respond to LIS The LIAISON®XL will respond to queries for results or not.
Query for
Results
Result Flag Sends the result flag as Short or Long text (e.g. “C” or “Calibration expired”).
Style
Send The LIAISON®XL will generate query messages during sample loading to query test orders for bar
Automatically coded patient samples.
Queries Host
for Worklist

Rev. D
Send The LIAISON®XL will upload patient results whenever results have become available.
Automatically
Default: Y; Values: Y or N
Sends All
Results
Send The result comment record is generated using repeat delimiters or not.
Compressed
Comments
Send The query for test orders is generated using repeat delimiters or not.
Compressed
Query
Send Frame Overwrites the ASTM1381 'Send Frame Timer’
Timer (No
Response)
Stop Bits Sends a stop bit (1) or not (0).
Default: 1; Values: 0, or 1
Time Template Must not be changed.
®
Timeout (Query) Within <Timeout> seconds the LIAISON XL expects a response to a query messages sent to the
host. If within <Timeout> seconds transmission of a response has not started yet the LIAISON®XL
will log in the event log that no response within timeout + SampleID without testorder.
Table 6-112: Functions of the LIS tab

Rev. D
Figure 6-45: Sub category LIS/LAS - LAS tab
LAS Tab The LAS tab is to specify the interface for exchanging information between the LIAISON®XL instrument and a LAS.
Apply Stores all changes.
COM Port This field specifies the serial port used for LAS transmission.
Default: 2; Range: 2, 4.

Rev. D
Baudrate Specifies the speed (baud rate) used for LAS transmission.
Default is 9600; Values: 9600, 19200, or 38400.
Enabled Stores all changes.
Reload Becomes enabled only when changes are made to that dialog. Reloads the current settings from
file to revoke all changes made (since last changes were applied). This makes the button disabled
again.
Table 6-113: Functions of the LAS tab

Rev. D
6.7.5 Sub Category Settings

The sub category Settings is used for user accounts management, run mode definitions and general settings.
Figure 6-46: Sub category Settings - Users tab
Users Tab There are several security levels of user access rights on the LIAISON®XL system. Some system functions are only available for users with
an appropriate access level (e.g. changing system options, or deleting results).
The purpose of the Users tab is to define the rights of each user.

Rev. D
Add Opens the User Setup display to add a new user to the systems (see chapter 6.7.5.1).
Details Opens the User Setup display to view or edit a selected user entry (see chapter 6.7.5.1).
Table 6-114: Functions of the Users tab
Column Description
User Name Shows the user name.
Access Level Shows the users allocated access rights as number (see chapter 6.7.5.1).
Privileges Shows the users allocated access rights (see chapter 6.7.5.1).
Patient Privilege Shows a * if the user has the privilege to view patient demographical data, otherwise empty.
Table 6-115: Columns of the users table

Rev. D
Figure 6-47: Sub category Settings - Others tab
Others Tab The purpose of the Others tab is to define settings related to the behaviour of the system in general.
Column Description
Mode Shows "Random Access" or "Batch", with the following meaning:
- in Random Access, the system will pipette all samples from one rack and release it as soon as
possible, then move to the next rack
- in Batch, the system will pipette from all available racks loaded in Sample Area
Software Language The language of the software. A change becomes effective after restart of the application.

Rev. D
IFU Language The language of the IFU (from the mini-CD). A change becomes effective after restart of the
application.
Date Format Date format used in the software, among the following options:
- MM/DD/YYYY
- DD.MM.YYYY
- YYYY-MM-DD
Time Format Date format used in the software, among the following options:
- 24 hrs
- 12 hrs AM-PM
Decimal Point Set the type of the decimal point, either “.” or “,”.
Result Archiving Allows selecting if results are manually or automatically moved to the Archived page.
Auto log-off If checked, the auto log-off time opens, allowing setting a time interval for auto log-off.
after ... minutes Editable only if "Auto log-off" is checked. Allows defining a time interval for auto log-off. After this
time is passed without user interaction, the log-in page will be prompted.
Auto-Backup (Days) The frequency in days when Auto Backup will be performed, i.e. when old Archived results will be
Frequency moved to an area where they are accessible via External Backup Viewer (see 6.11). The value “0”
disables the feature.
Auto-Backup (Days) After an Auto Backup the system deletes all results from the current Archived page that are older
Delete Results than specified days (see Auto-Backup (Days) Frequency). The value “0” means that no results
older than are deleted. Ignored if "Auto-Backup Frequency" = 0.
Auto mute Defines a time span, after which the audible (and visible if provided) alarm will be switched off
Interval….minutes automatically. If set to ”0” then the alarms will not be switched off.
Apply Saves the current settings.
Reload Revokes the settings made since last changes were saved.
Table 6-116: Columns of the Others tab

Rev. D
6.7.5.1 User Setup: Details or Add
The User Setup display enables to add a new user or to change the rights of a user.
Figure 6-48: User Setup display
Expiry Period The user must change his/her password by specified day.
Name Name of a user. The user name must be unique. Any sequence of alphanumeric characters
(spaces are allowed) can be entered as a user name.
Password Field for the (first) user password.
Any alphanumeric chain of characters can be used as password. The password is case sensitive.
Note: any newly added account will have the default passoword “diasorin”. It shall be changed as
soon as possible.
Password never If checked, the user does not have to change his/her password as scheduled.
expires
Patient Privilege Defines, if the user has the privilege (Yes or No) to view patient demographical data.

Rev. D
Privilege Level Defines the access rights for the user, default are:
 LabUser (1000)
 LabSuper (2000)
 LabAdmin (3000)
Table 6-117: Functions of the User Setup display

Rev. D
6.7.6 Sub Category Test Statistics

The sub category Test Statistics can be used to get information about the started tests. Among others the LIAISON®XL system shows the
amount of test results with the result done or failed for each assay.
Figure 6-49: Sub category Test Statistics
Export Exports the test statistics to a file
Month Filter: Shows only the statistic entries of the selected month.

Rev. D
Year Filter: Shows only the statistic entries of the selected year
Table 6-118: Functions of the Test Statistics tab
Column Description
Assay Name of the assay.
Successful Cals Number of successfully or unsuccessfully performed calibrations.
+ Failed Cals
Successful Number of successfully or unsuccessfully performed control determinations.
Controls +
Failed Controls
Successful Number of successfully or unsuccessfully performed patient sample determinations.
Samples +
Failed Samples
Table 6-119: Columns of the test statistics table
6.7.7 Sub Category Versions

The sub category Versions is used to inform the user about the LIAISON®XL software and the LIAISON®XL instrument firmware versions.

Rev. D
Figure 6-50: Sub category Versions
Liaison XL Shows the version of the current LIAISON®XL software version.
Version
Serial Number Shows the serial number of the LIAISON®XL instrument.
Table 6-120: Functions of the Versions sub category

Rev. D
Column Description
PC Software Shows the name of several modules of the current LIAISON®XL software.
Module
Version Shows the version.
Firmware Shows the name of the modules of the LIAISON®XL instrument.
Module
Table 6-121: Columns of the version tables

Rev. D
6.8 Main Category Diagnostics
In the main category Diagnostics and its subcategories, information about the LIAISON®XL system can be found.
Perform tasks from Diagnostics only guided by local support.

Rev. D
Figure 6-51: Main category Diagnostics
Calibrate OLV Starts an OLV calibration. The result of the calibration (OK or Failed) will be placed in the Result
field.
Clear Cuvettes Starts a command to empty the incubator, washer and reader. No more cuvettes will be requested
by the cuvette related assemblies before the incubator will not move.
Incubator Initialises the incubator after the Initialize button has pressed.

Rev. D
Initialize Starts the initialisation.
Internal/external Shows the read bar-code of the sample barcode scanner or the handheld scanner. This field is
scanner content emptied by pressing the Sample Scanner button.
Leave Leaves the diagnostics dialog, causing the system to initialise and go back to Standy mode.
Load Cuvettes Fills the empty positions in the incubator with cuvettes.
Low level Low level command as byte sequence in hexadecimal notation. It is sent to the instrument, if the
command Send button is pressed.
Reader Initialises the Reader after the Initialize button has pressed.
Pipettor Left Initialises the left pipettor arm after the Initialize button has pressed.
Arm
Pipettor Right Initialises the right pipettor arm after the Initialize button has pressed.
Arm
Reset LL2. Lane Resets the liquid levels of improperly offline vials for the integral loaded in the lane 2.
Note: After the reset, it is necessary to remove the integral from lane 2 and reload it in any
available lanes.
Note: Use this button only when recommended by DiaSorin representative.
Result Shows the result of the OLV calibration (OK or Failed).
Sample Scanner Button Sample Scanner:
 Clears the field internal/external scanner content.
Checkbox Sample Scanner:
 Initialise the sample scanner after the Initialize button has pressed.
Send Sends the entered low level command to the instrument.
Washer Initialises the washer after the Initialize button has pressed.
Table 6-122: Functions of the Options sub category

Rev. D
While the system is in Diagnostics mode, it is recommended not to initialize the system via the STOP menu.

Rev. D
6.9 Main Category Maintenance
The main category Maintenance and its subcategories allow performing necessary maintenance tasks to obtain the system performance.
6.9.1 Sub Category Schedule

In the subcategory Schedule, maintenance tasks can be managed or started. The individual maintenance tasks can be generated in such a
way that they are startable either if required or on schedule. As soon as a scheduled maintenance task is due, this is indicated by a flashing
Maintenance main category tab or Schedule subcategory tab.
Figure 6-52: Sub category Schedule

Rev. D
Details Shows details about a selected maintenance task (see chapter 6.9.1.1).
Import Opens the Select File dialog to import a saved maintenance task from a file.
Note: All existing maintenance tasks will be deleted before the system imports saved maintenance
tasks.
Perform Opens the Perform Task dialog (see chapter 6.9.1.2) and starts the selected maintenance task.
Follow the instructions on the dialogue.
The Perform button is disabled when the selected maintenance task cannot start.
Table 6-123: Functions of the Schedule sub category
Column Description
Name Name of the maintenance task.
Interval Displays the interval for the maintenance task in days or nothing (‘As needed’) if there is no
interval defined.
Due Date Shows the date and time when the next run for the maintenance task is due. The cell is empty, if
interval is 'As Needed’.
Due Shows with a color indicator upcoming maintenance tasks.
Table 6-124: Columns of the Schedule table

Rev. D
6.9.1.1 Maintenance Task Details: Details
Figure 6-53: Maintenance Task Details display
Description Description of the maintenance task.
Due Time Date and time when the next run for the maintenance task is needed. Empty if interval is 'As
Needed’.
Interval Interval for the maintenance task in (1 - 365) days or nothing (‘As needed’) if there is no interval
defined.
Procedure Shows a list with all predefined maintenance task procedures.
Table 6-125: Functions of the Maintanace Task Details display

Rev. D
6.9.1.2 Perform a Maintenance Task
Figure 6-54: Perform Task display
Abort Aborts the maintenance task procedure and closes the Perform Task display. A new maintenance
log entry will not be generated.
After a maintenance task is aborted, the system will stay in Maintenance mode. Start a rinse
procedure to flush the tubings.
Date Shows the current date.
Done This button is prompted after the last step is finished and the maintenance task failed. Allows
closing the Perform Task display.
Perform Task Shows detailed information about the current performed step.
Wizard
Procedure Shows the maintenance task steps.
Task Shows the maintenance task name.
User Name Shows the log-in name.
Table 6-126: Functions of the Perform Task display

Rev. D
After a maintenance task has been successfully completed, the Perform Task display gets closed automatically.
Before starting a maintenance task ensure that the Start button is enabled.

Rev. D
6.9.2 Sub Category Log

The sub category Log shows a list with all maintenance task entries, either successfully or unsuccessfully performed.
Figure 6-55: Sub category Log
Details Shows details about a selected maintenance log entry.
Export Opens the Save As dialog to export one or more selected maintenance log entries to a file.
Table 6-127: Functions of the Log sub category

Rev. D
Column Description
Date Shows the date and time when the maintenance task was performed.
Status Shows the result Done or Failed of the maintenance task.
User Shows the name of the user who performed the maintenance task.
Table 6-128: Columns of the Log table

Rev. D
6.10 Main Category Status
In the main category Status, the filling level of the different containers, bottles and waste containers can be accessed. Additionally, there is
the possibility to check the temperatures of the individual modules. The loading of the system with cuvettes and disposable tips is also
performed in this main category.
6.10.1 Sub Category Summary

Besides the indication of the temperatures in the individual modules and the filling level of the different containers, bottles and the waste
container, the system can be filled with cuvettes in this sub category Summary.
Figure 6-56: Sub category Summary

Rev. D

Water at least 30% in range 13%-30% running out (less than Disconnected "Active" tests are not
13%) counted.
Wash Buffer at least 30% in range 12%-30% running out (less than Disconnected "Active" tests are not
12%) counted.
Starter at least 80 injections less than 80 running out (0,1,2 Absent (bottle not Thresholds are
injections injections) loaded) compared with the
difference between
Present (bottle not
number of available
primed)
shots and "active"
Not Available (bottle tests. Red is reached
empty or offline) when this difference
is 0.
Cuvettes cuvettes are detected cuvette buffer is running out (less than Based on sensors
by sensors empty 3 cuvettes detected) detection
Solid Waste no more than 1700 in range 1700-2000 nearly full (more than Pulled Out "Active" tests are not
2000) counted for yellow
(cuvettes/tips)
status.
Red threshold is
compared with the
sum of number of
cuvettes (tips) in
waste bin and
"active" tests.
When pulled out,
there is space for no
more than 50.

Rev. D
Liquid Waste no more than 70% in range 70-84% nearly full (more than Absent (tank not Thresholds are
84% liquid) loaded) referred to the total
amount of the two
tanks.
"Active" tests are not
counted.
Table 6-129: Used colour code
Symbol Meaning
Container connected and active
Container connected and inactive
Container not connected
Table 6-130: Used symbols
System Fluids Shows the usable volume of the Water and the Wash Solution containers [in percent].
Group
Cuvettes Group Function Description

Added Bag Press this button after refilling cuvettes. The Cuvettes counter increments of 200.
(1 cuvette bag = 200 cuvettes)
Cuvettes Shows the number of cuvettes in the instrument.
Reset Press on this button to set the Cuvettes counter to 0.
Table 6-131: Functions of the Cuvettes group

Rev. D
Tips Group Shows the number of unused disposable tips in the instrument.
Waste Group Shows the filling level of the liquid waste containers (Tank 1 and Tank2) in per cent, and Solid waste (cuvettes and disposable tips).
Reset Press on this button to clear the counters.
Changes the used waste tank:
 Tank 1 > Tank2: Used tank: Tank 1
or
 Tank 1 < Tank2: Used tank: Tank 2
Table 6-132: Functions of the Waste group
Starter Reagents Shows remaining injection counters of all loaded starter reagents. The counter decreases after every injection.
Group The information is reported only when the starters after correctly primed by the system.

Rev. D
6.10.2 Sub Category Disposable Tips

In the subcategory Disposable Tips, the system can be filled with disposable tips.
Figure 6-57: Sub category Disposable Tips
The window of the Disposable Tips sub category shows on the left side both drawers for disposable tip trays and on the right side the
selected disposable tip tray of the drawer (red marked).
See chapter 5.5.2 for detailed procedure.

Rev. D
Assign Gives access of the drawer to the pipettor. The LED below the physical drawer and the indicator
above the drawer on the display change to yellow.
The Assign button is only available when the drawer is closed.
Delete All Deletes all disposable tips on the single disposable tip tray.
Set All Fills the single disposable tip tray with disposable tips.
Withdraw Gives the access of the drawer to the user. The LED below the drawer and the indicator above the
drawer on the display changes to red.
Note: If the instrument is pipetting the pipettor will use the other drawer. If there are no disposable
tips or the drawer is also opened, the pipettor stops.
Table 6-133: Functions of the Disposable Tips sub category

Rev. D
6.10.3 Sub Category Temperatures

The sub category Temperatures shows the current temperature of several modules next the module name. Additionally the Min (minimum)
and Max (maximum) temperatures are shown. In case any temperature falls out of tolerances then the value is displayed in red (see chapter
10.9 for temperature ranges) and the system will react accordinly (tests may be failed or not be started).
Figure 6-58: Sub category Temperatures

Rev. D
Unit Use this list to change the temperature unit (°C or °F).
Table 6-134: Functions of the Temperatures sub category

Rev. D
6.10.4 Sub Category Missing Resources

The sub category Missing Resources gives an approximated overview of any missing reagent or consumable, based on system estimations.
It is updated after the routine has been started.
Figure 6-59: Sub category Missing Resources
Table 6-135: Functions of the Missing Resources sub category

Rev. D
Column Description
Resource Name of the missing resource.
Amount Missing liquid volume or number of objects.
Warning Warning indicator. A missing warning indicates that that resource will be potentially missing. A
present warning indicates that that resource will be certainly missing.
Table 6-136: Columns of the Missing Resources table
Resource Amount
Ancillary Required ancillary volume for the open tests. May be followed by Lot No. and Kit No.
Cuvettes Number of missing cuvettes.
Disposable tips Number of missing disposable tips.
Integral Number of missing determinations for the open tests. May be followed by Lot No. and Kit
No.
Liquid waste container Waste volume corresponding to the missing tests.
Solid Waste Number corresponding to the missing tests due to solid waste.
Starter reagent Required starter volume for the open tests.
Wash buffer Required wash buffer volume for the open tests.
Water container Required water volume for the open tests.
Table 6-137: Meaning of Amount

Rev. D
6.10.5 Sub Category Inventory

The sub category Inventory shows a list of all loaded assays/integrals in the reagent bay including the combi assays. The dialog is updated in
regular intervals.
Figure 6-60: Sub category Inventory

Rev. D
Table 6-138: Functions of the Inventory sub category
Column Description
Assay Assay abbreviation.
Lot Lot number of the integral.
Number Number of remaining calibrated determinations.
Table 6-139: Columns of the Inventory table

Rev. D
6.11 External Backup Viewer
The external backup viewer can be used to view archived patient tests from autobackup files.
While the External Backup Viewer is running, the LIAISON®XL system software can not be accessed, but the
LIAISON®XL system software is still running and working in the background.
Main Category
Selection
Figure 6-61: Main category Selection

Rev. D
Exit Closes the External Backup Viewer and returns to the LIAISON®XL software.
Select Enables the user to open and view a selected backup file.
Selected Shows the name of the last opened backup file.
Archive
Table 6-140: Functions of the Selection main category
Column Description
No Number of the backup.
Name Name of the backup file.
Size Needed storage space on the storage device.
Table 6-141: Columns of the Selection table

Rev. D
Main Category
Results
Figure 6-62: Main category Results

Rev. D
Table 6-142: Functions of the Results main category
Column Description
and Time
RLU Shows the raw results (in Relative Light Units).
Qualitative Shows the result as qualitative evaluation (e.g. positive, negative etc.)
Label
Flags List of flags. For details about the flags see chapter 5.9.5.
Table 6-143: Columns of the Results table

Rev. D
Procedure 1. Start the external backup viewer from the sub category Applications (see chapter 6.7.2) in the main category System.
2. Enter the user name into the User box.
3. Enter the password into the Password box.
The password is case sensitive!
4. Click on the Login button.
The external backup viewer shows the main category Selection.
5. Select the desired backup file.
6. Click on the Select button.
The external backup viewer shows the Extracting Zip File dialog.
7. Click on the OK button to extract the desired backup file.
8. Click on the main category Results.
The external backup viewer shows all archived patient results from the backup file.
9. Select a result entry.
10. Click on the Details button.
The external backup viewer shows the details.
11. After the usage of the external backup viewer, click on the Exit to return to the LIAISON®XL software.

Rev. D
7 Quality Control (QC)

The quality control application supports quality control in clinical diagnostics. The purpose of QC is to find problems in an analytical system
early. Thus, QC ensures the integrity of analytical results. QC must be performed for each analytical system, and for each assay that is
performed with this system.
QC is performed by analysing control material during each analytical run, in which patient samples are tested. Control material contains a
fixed concentration (target value) of a specific analyte. Thus, testing the control material with an analytical method for this analyte should
produce an expected result (if the analytical process is performed trouble-free). If one or more results of control samples have a large
difference from the expected results, a problem in the analytical system or method may be detected.
To find out if a control result indicates an analytical problem, the control results are evaluated based on either the target value range (defined
by the producer of the control material) or on so-called "intralaboratory" limits.
Intralaboratory limits have to be calculated for each combination of: Analyzer instrument, method (assay), control material, control material lot.
7.1 Working Method
7.1.1 Accuracy and Precision Controls

Accuracy controls are evaluated against fixed limits. Precision controls are evaluated against a CV/SD (relative values).
Precision controls need a preperiod to calculate intralaboratory CV, SD and limits.

Rev. D
7.1.2 Preperiod and Control Periods

The intralaboratory limits are calculated based on gaussian distribution. In a so-called preperiod, a certain number of control samples have to
be tested with the target assay on the analytical system. From the control results of these tests, the mean and standard deviation (SD) are
calculated.
Then, the control material can be used to evaluate the integrity of analytical runs in which patient results are generated. These analytical runs
are grouped in so-called "control periods" Control results are then evaluated with regard to the mean and standard deviation values that were
calculated in the preperiod. The rules which shall be applied to evaluate control results depend on local and international regulations.
7.1.3 Cumulative Mean, SD, CV

In order to establish longer term estimates of the mean and standard deviation, the control data or calculated results may need to be
accumulated to describe performance observed over a longer periods of time. Longer term limits are often described as "cumulative limits,"
which indicates they have been calculated from cumulative means and standard deviations. [Westgard]
7.1.4 Westgard Rules

Westgard rules give indication for random errors or systematic errors in an analytical system. A Westgard rule describes how the value of one
or more control results shall be checked. If a control result violates a Westgard rule, this indicates an analytical error. Westgard rules are
based on mean and standard deviation values for the control material lot from which the control sample was taken.
There are 3 types of Westgard rules:
Position rules: 1 ZS:
A position rule is violated, if 1 control result has a value that is higher than z * SD, or if 1 control
result has a value that is lower than -z * SD.
A popular position rule is the 1 3S rule (one result above the +3*SD limit, or below the -3*SD limit).#
#
In a gaussian distribution, about 99.7 % of the values fall within a range that reaches from -3 sigma below the mean
value to +3 sigma above the mean value (sigma is the value of the standard deviation). Therefore, it would be very
unexpected (0.3 % chance) to observe a control value more than 3 SD from the mean, and such an observation usually
indicates that there is a problem in the analytical system (RiLiBÄK uses this 3 SD rule).
Range rules: x of y R ZS:

Rev. D
A range rule is violated, if the values of x out of y consecutive results have a difference of more than
z * SD. (e.g. 2 of 3 R4S)
x R ZS:
Short form of the above notation for x out of x consecutive results (e.g. 3R4S).
Trend rules x ZS:
Violated if x consecutive control results have a value that is higher than z * SD, or if x consecutive
results have a value that is lower than -1 * z * SD.
zs in the rule description can also be replaced by (x-bar, the mathematical symbol for the mean;
this is equivalent to z=0). For example, a 10 rule is violated, if 10 consecutive results are above
the mean, or if 10 consecutive results are below the mean.
x of y ZS:
A trend rule of this is violated, if x out of y consecutive control results have a value that is higher than
z * SD, or if x out of y consecutive results have a value that is lower than –1 * z * SD.
(if z is 0: that corresponds to the mean  x of y ).
x T:
For example: 7T. A rule of this type is violated, if the values of x or more consecutive results are
either monotonically increasing or monotonically decreasing.
Within material / Rules can also be applied either "within material" or "across material".
across material  For a rule which is applied "within material", all inspected results shall be from the same control material.
 For a rule which is applied "across material", all inspected results can be from more than one control material.

Rev. D
Example:
Figure 7-1: Violations within and across material
7.1.5 Multirule QC
QC rules are defined in a rule set, which contains one or more QC rules. For each assay, a dedicated rule set is used. Each control result that
is generated with this assay may not violate any one of the QC rules in this rule set. If a control result violates a QC rule, the control result may
not be considered valid until lab staff can prove contrary.
7.1.6 RiliBÄK rules

RiliBÄK are literally the guidelines of the German Medical Council and they are the acronym for the German sentence “Richtilinien der
Bundersärztekammer”. The RiliBÄK rules are designed to supply the minimum requirements for the quality of test results in medical
laboratories. Besides, those requirements tie up with the well-known ISO 15189 principles and standards as well as defining specific quality
requirements, allowable errors and uncertainty recommendations.

Rev. D
7.1.7 Levey-Jennings-Chart
For visual control of Westgard rules, the control results can be drawn into a so-called Levey-Jennings-Chart (LJC). A Levey-Jennings-Chart
displays on the x-axis the time, and on the y-axis the concentration values of the control results.
For evaluation of QC rules, the -3*SD, -2*SD, -1SD, mean, +1*SD, +2*SD and +3*SD limits are drawn as horizontal lines (see the following
graphic for a simple example of a Levey-Jennings-Chart, that indicates a 13s violation at the 1st result and a 22s violation at the 2nd and 3rd
result). The LJC should be scaled from +4*SD to -4*SD.
Figure 7-2: Example of a Levey-Jennings-Chart
Regulations do not only specify Westgard rules that controls must comply with, but the regulations also specify other limits that may depend
on the target value range that the manufacturer of the control material specifies for each control material lot.

Rev. D
7.2 Working Procedure for Users
The quality control application shall receive QC data from the LIAISON®XL software, and will import that data (import may be started by the
user).
In the quality control application, the user selects control results and triggers the software to display a chart for the selected results.
The user will be able to reject results or periods presented by the display, but not to edit or change the values. Rejected values shall still be
shown on the display but with an appropriate note, flag or comment.
If a result or period was rejected, the user shall investigate the analyzer system for the reason of the rejection (outside the QC software). The
user then shall document in the quality control application the reason and the corrective action that was taken. The user may accept a rejected
result or period.

Rev. D
7.3 Functions of the Quality Control Application
In this chapter, the complete quality control application is described in detail. Hereby, the main focus is not on the general context and the
processes but on a complete description of all functions, buttons, lists etc. This chapter can therefore be considered as a reference book for
the quality control application.
7.3.1 Header
Every available page of the QC software is provided with an header. The header consists of a thick black horizontal bar displayed at the top of
the screen view, and it contains the items listed in the next Table.
Software version The current version of QC application
Username of logged in user The current user that use the QC application
Privileges of logged in user The rights for QC of current user. User can view some screens depending of these privileges
Current Date and Time Current date and time of operating system
LiaisonXL QC application will be hidden, and one QCBackground.xml file is created. This button is
present only if the LiaisonXL MainUI is running in background.
Exit Closes the quality control application
Table 7-1: The items present in the header

Rev. D
7.3.2 Main Category Loading

This section is for the import of files. All files, new or quarantined go through the same process, however, the quarantined files may have a few
more steps in that the details are loaded up on screen for the user to check and edit where necessary.
The processes a file go through are:

 Get Data
 Check Minimum Requirements
 Has the control material already expired?
 Does the Run already exist in the database?
 Does the result belong to an open pre-period or period?
 Does the pre-period or period expire after this result/run?
 Westgard rule check
 If RiliBÄK is on, then a RiliBÄK rule check is also done.

Rev. D
7.3.2.1 Sub Category Import Data
Figure 7-3: Sub category Import Data

Rev. D
All Files Enables the quality control application to import all shown files.
Import File(s) Imports all or all selected files into the database.
Enable Multi Select Allows the user to select multiple files from the list using a touch screen
Only selected files Enables the quality control application to import only the selected files.
Table 7-2: Functions of the Import Data sub category
Column Description
File Name Name of files that are waiting to import. File name must start with: QCData string
Created Date Creation date of the file.
Table 7-3: Columns of the Import Data table.
The file names and their relative information are displayed in the table shown in the previous table only if the data
import mode is manual.

Rev. D
7.3.2.2 Sub Category Quarantine Files
Reasons for a file being quarantined include:

 Missing data (after the minimum requirements check)
 There is an error matching an analyte,
 There is an error adding information to the database.
Figure 7-4: Sub Category Quarantine Files

Rev. D
Quarantined Files Shows a list of all files held in the quarantined area. On selecting an item from the list, the fields in the rest of the screen will be populated with
the available information. Any areas where data is lacking will be displayed in red.
Lab Details Function Description

Group Address Shows the address of the laboratory.
Name Shows the name of the laboratory.
Table 7-4: Functions of the Lab Details group
Analyzer Details Function Description

Group Shows the name of the analyzer manufacturer.
Manufacturer
Name Shows the name of the analyzer.
Serial Number Shows the serial number of the analyzer.
Table 7-5: Functions of the Analyzer Details group
Assay Details Function Description

Group
Calibration Date Indicates the calibration date of the assay.
Kit No Shows the kit number of the assay.
Lot No Shows the lot number of the assay.

Rev. D
Matrix Indicates the assay matrix urine, blood etc.
Measuring Indicates the measuring method/ units used for the assay.
Method
Name Shows the name of the assay.
Table 7-6: Functions of the Assay Details group
Result Details Shows a list of all results available in the quarantined file.
Group Function Description
Cancel All data will be cleared.
Import Creates a new import file with all added details that the user had entered. After creation the file will
be imported. If there are still problems, it is re-quarantined.
Table 7-7: Functions of the Result Details group
7.3.3 Main Category Results

This section is to allow the user to view and assess the results.
The screen highlights any results that have failed or contributed to the fail of a Westgard rule, as well as give the user various viewing options
such as the x axis scale and whether they want to view the results against standard deviation values or given target values.
Should the user decide to reject a result, the period is checked against Westgard and RiliBÄK rules again to see if there are any new failure or
whether the removal of a result caused a previous fail to now pass.

Rev. D
7.3.3.1 Sub Category Results
Figure 7-5: Sub Category Results
+, - Zoom in on the centre of the graph or zoom out from the centre of the graph..
Add / View Allows to type in any new comments against the selected period(s).
Period
Comments

Rev. D
Add / View Allows to type in any new comments against the selected result(s).
Result
Comments
Apply Rule When checked, Westgard rules are applied across all periods using the selected control material.
Across Material When unchecked, westgard rules are applied to each period separately.
However, range rules are not applied across materials.
Close Period Close a period. The user will be asked if this is what they really wish to do, and if so they will have
to enter some notes before proceeding,
CV The calculated value for selected period
Edit Results Only results that have been manually entered can be edited. If the user selects a series of results
that have not been manually entered, the user will be informed they can not edit these results.
However, on selecting a series of manually entered results, the Edit Results screen will be
displayed.
Enable Multi Enables the user to select more than one result.
Select
Exclude Results On selecting an individual result from the data grid or the graph, this button will become visible. On
click, the user will be prompted to add notes before saving or rejecting the result. If the result is
part of a pre-period that has already been accepted, the result can not be rejected.
First filter level Sets a filter for the period tree (top entries of the tree).
list
1. Lab: Shows as top entries all laboratories.
2. Analyzer: Shows as top entries all analyzer. The laboratories won't be shown.
3. Assay: Shows as top entries all assays. The laboratories and analyzers won't be shown.
4. Control: Shows as top entries all controls. The laboratories, analyzers, assays, and analytes
won’t be shown.

Rev. D
Graph Displays a graph with the results on. When scrolling over a point, details about that result will be
displayed. If a result (or series of results) has a box around it, that result (along with some or all of
the results within the box) has failed a Westgard rule. Scrolling over the box will display a list of the
results that broke a particular rule.
The graph's current colour and shape code is:
 Red star: result failed rule.
 Black Diamond: normal result.
 Green Circle: Point excluded.
 Blue cross shape: Point selected.
 A large Black line now divides periods displayed in the graph
 For Precision results, the pre-period graph will be coloured in Pink.
Period tree Allows the user to drill down to find period(s) for a particular lab - analyzer - assay - analyte.
Tree view Colour scale is:
 Blue (any shade) periods with errors containing newly imported results.
 Black: Live open periods
 Grey or light Blue: Closed Periods.
Periods filter list Defines what periods will be shown in the period tree.
 All Valid Periods: All periods will be shown, except ones which have been rejected
 Open periods: Only open periods will be shown.
 Periods With Errors: Only periods with errors (Westgard and RiliBÄK) will be shown.
 Rejected Periods: Analytes etc that belong to a rejected period will be shown.
Print / Export Prints the data or exports it to a csv-file.

Rev. D
Reject Period Rejects a period. The user will be asked if this is what they really wish to do, and if so they will
have to enter some notes before proceeding.
Result table Displays a grid showing all the results for the selected period(s).
Grid view colour scheme:
 Red: result has broken a rule.
 Green: result is excluded.
 Black: normal result.
Rules Applied This button is only displayed when an assay has been selected. It will open a new screen
displaying a grid with all the rules applied to that assay in it.
Scale graph X Allows to select how the X axis on the graph should be displayed. Display factors: Day, Week, or
axis by Month
This panel only becomes visible when one or more periods is being displayed in the graph
Scroll bars Allows to scroll up and down or scroll left and right the graph to see points that cannot fit on the
graph.
Show Excluded When checked, shows the results that have been excluded from the statistics, both on the graph
Results (green circle) and in the data grid (text in green). When un checked, excluded results are not
shown.
Show Key Opens a new screen displaying the graph's current colour and shape code (see Graph).
Show periods When selected, a new screen will be displayed that will show up to 3 periods/pre-periods on 3
separately separate graphs within one page. When the screen is closed, the check box becomes unchecked.
On un-checking, the screen is closed.
Show Plot Line When checked, the line that joins each result on a graph is displayed. When un checked, the line
is not displayed.
Tabs – An Accuracy Tab is present, allowing the user to analysis results against accuracy values. Results
Accuracy tab deriving from precision controls cannot be viewed by pressing this tab, which is not selectable in
this case.

Rev. D
Tabs – A Precision Tab is present, allow the user to analysis results against precision values. Results
Precision tab deriving from accuracy controls cannot be viewed by pressing this tab, which is not selectable in
this case
Tabs – A Westgard tab is present, allowing the user to analyse results against Westgard Rules.
Westgard tab
Tabs – Rilibak A RiliBak tab is present, allowing the user to analyse results against RiliBÄK Rules.
tab
Note: This tab is only shown when RiliBÄK is enabled. If RiliBÄK is disabled, this tab is not
shown.
Use Cumulative Cumulative values are used on results.
Values
Table 7-8: Functions of the Results sub category

Rev. D
7.3.4 Main Category Settings
7.3.4.1 Sub Category Westgard Rules
A Westgard rule can be applied to a rule set, with the rule set being applied to the assay, or it can be applied directly to an assay. This screen
handles both rules applied to rule sets and rules applied to an assay.
Figure 7-6: Sub Category Westgard Rules

Rev. D
Add Rule(s) to The rule selected in the rules not included box will move into the rules included box.
Ruleset
Add Ruleset(s) This button will only become enabled when an assay is selected and a rule set not used by that
to Assay assay is selected.
On clicking, the selected rule set will move into the rule sets included in assay box.
Available This box displays a list of all assays. On selecting an assay, the various boxes on the screen will
Assays list display which rule sets and rules are or are not applied to the selected assay.
Available On load this list displays a list of all available rule sets. However if an assay has been selected,
Rulesets list then this box displays a list of all rule sets used by that assay.
Cancel The new rule set will not be added to the database.
Create New If an assay is selected when the user clicks on this button, they will be asked if they wish to apply
Ruleset the rule set to the selected assay.
Default Ruleset Selecting this option will mean that this rule set and all the rules within it will apply to all periods
created after the rule set has been created.
Name Name of a new rule set.
OK The new rule set will be added to the database.
Remove Rule The rule selected in the rules included box will become greyed out as it no longer applies to the
from Ruleset selected rule set.
Remove Ruleset This button will only become enabled when an assay is selected and a rule set used by that assay
From Assay is selected.
On clicking, the selected rule set will move into the rule sets not included in assay box.
Reset Page When this page is first loaded, a list of assays is displayed, and a list of rule sets. On clicking this
button, the view will go back to how it was when first loaded.
Rules Included The rules displayed in this list are applied to a rule set.
in Selected
Ruleset list

Rev. D
Rules Not This list is not visible initially, but becomes visible when an assay is selected from the assay list
Included in box. It displays a list of any rule sets that are not applied or used by the selected assay.
Selected
Ruleset list
Rulesets Not The rules displayed in this list are not applied to a rule set.
Included in
Selected Assay
list
X of Y zs An assay or rule set must be selected before this button becomes visible, as all rules must be
applied to one or the other.
On clicking this button, a new window will open allowing the user to create a trend rule stating (for
example) that 4 of 5 results are above a certain standard deviation.
X zs An assay or rule set must be selected before this button becomes visible, as all rules must be
On clicking this button, a new window will open allowing the user to create a position rule.
xR zs An assay or rule set must be selected before this button becomes visible, as all rules must be
On clicking this button, a new window will open allowing the user to create a range rule.
Zt or Zx An assay or rule set must be selected before this button becomes visible, as all rules must be
On clicking this button, a new window will open allowing the user to create a trend rule. This can
be a monotonical trend (Z consecutive results are increasing or decreasing) or just have z
consecutive results all above or all below the mean.
Table 7-9: Functions of the Westgard Rules sub category

Rev. D
7.3.4.2 Sub Category Default Values
This screen is to allow the user to change the Period/Pre-period default lengths. Changes to these lengths can only be performed when
RiliBÄK is disabled.
Period length types can be: Days, Results/Determination and Infinite. Pre-period length type can be: Days and Results/Determination.
Figure 7-7: Sub Category Default Values

Rev. D
Assay List of all Assays from database
Cancel Will reset the values, if an Assay has been selected from the drop down list, the details of that
Assay will be re-set.
Period Length User can choose the length type, and a length value for selected type
Pre-period User can choose the length type, and a length value for selected type
Length
Save Saves the new assay values or the changes to the existing assay values in the database.
Table 7-10: Functions of the Default Values sub category

Rev. D
7.3.4.3 Sub Category Config
This screen is to allow the user to change any configuration settings they may have created on setting up the application. In order for these
settings to take affect, the user needs to restart the application.
Figure 7-8: Sub category Config - Import Settings tab

Rev. D
Import Settings Tab page to allow the user to change the file import settings.
Tab
Cancel Re-sets the settings.
Default File Shows the location of the default files.
Location
Import Method Manual Import or File watch are the options in this box, meaning the user can manually import
the data by selecting the data to import or by file watch which processes the file when they arrive
in the default file location.
OnScreen When selected the virtual keyboard can be used.
keyboard
Quarantined Shows the location of the quarantine files.
File Location
Save Saves the settings.
Table 7-11: Functions of the Config sub category - Import Settings tab
Export Settings Tab page to allow the user to change the file export settings. In current version of QC, these paths are read-only.
Tab
Audit Export Shows the location of the audit export files.
Location
Archive File Shows the location of the archive export files.
Location

Rev. D
Results Export Shows the location of the results export files.
Location
Table 7-12: Functions of the Config sub category - Export Settings tab
RiLiBÄK Settings Tab page to allow the user to change the RiliBÄK settings.
Tab Function Description
Enable RiliBÄK If checked, RiliBÄK is turned on, if not, RiliBÄK is turned off.
Table 7-13: Functions of the Config sub category – RiLiBÄK Settings tab
Westgard Tab page to allow the user to change the Westgard settings.
Settings Tab Function Description
Enable Across Enable/disable the use of Across Material
Material
Enable Enable/disable the use of cumulative calculation
Cumulative
Calculation
Table 7-14: Functions of the Config sub category – Westgard Settings tab

Rev. D
7.3.5 Main Category Maintenance

The maintenance sub categories are to allow the user to add or edit each different aspect that creates a period.
7.3.5.1 Sub Category Lab
Figure 7-9: Sub Category Lab

Rev. D
Address Address of the laboratory.
Cancel Will reset the values, if a laboratory has been selected from the drop down list, the details of that
laboratory will be re-set. This cannot happen after details have been saved.
Lab List of available labs. If the user selects a laboratory in the list, the labs details will be filled in the
name and address fields for the user to edit. If they select [New Lab] the name and address fields
will become blank for the user to enter a new laboratory.
Name Name of the laboratory.
Save Saves the new laboratory or the changes to the existing laboratory in the database.
Table 7-15: Functions of the Lab sub category

Rev. D
7.3.5.2 Sub Category Analyzer
Figure 7-10: Sub Category Analyzer

Rev. D
Analyzer List of available analyzers. If the user selects an analyzer from the list the analyzers details will be
filled in the following fields for the user to edit.
Cancel Will reset the values, if an analyzer has been selected from the drop down list, the details of that
analyzer will be re-set. This cannot happen after details have been saved.
Lab A drop down list of all available laboratories for the user to select the one the analyzer is located
at.
Manufacturer Name of the analyzer manufacturer.
Name Name of the analyzer.
Save Saves the new analyzer or the changes to the existing analyzer in the database.
Serial Number Serial number of the selected analyzer (or blank if new analyzer).
Table 7-16: Functions of the Analyzer sub category

Rev. D
7.3.5.3 Sub Category Analyte
If the user has selected to view only assay details when installing the application, this screen will not be available.
Analyte tab will only become available upon enabling RiliBÄK. There is not possible to assign an Analyte to more than one Assay, and it’s not
possible to edit an assigned Analyte, if an open period exists for the Assay.
Figure 7-11: Sub Category Analyte

Rev. D
Analyte List of available analytes. If the user selects an analyte, the analytes name will be populated in the
field below.
Analyte Matrix This data grid displays a list of all matrix available for a particular analyte.
Assay Name An analyte can be linked to an Assay Name.
Cancel Will reset the values, if an analyte has been selected from the drop down list, the details of that
analyte will be re-set. This cannot happen after details have been saved.
Name Name of the analyte.
Save Saves the new analyte or the changes to the existing analyte in the database.
Table 7-17: Functions of the Analyte sub category

Rev. D
7.3.5.4 Sub Category Assay
If the user has selected to view only analyte details when installing the application, this screen will not be available.
Figure 7-12: Sub Category Assay

Rev. D
Assay List of available assays. If the user selects an assay, the details associated with that assay are
populated in the fields below.
If the user selects [New Assay] the fields mentioned below will be left blank.
Calibration Indicates the calibration date of the assay.
Clear When selected the Calibration field will be set to blank
Calibration Date
Cancel Will reset the values, if an assay has been selected from the drop down list, the details of that
assay will be re-set. This cannot happen after details have been saved.
Kit No Shows the kit number of the assay.
Lot No Shows the lot number of the assay.
Matrix Indicates the assay matrix urine, blood etc.
Measuring Indicates the measuring method/ units used for the assay.
Method
Name Name of the assay.
Save Saves the new assay or the changes to the existing assay in the database.
Table 7-18: Functions of the Assay sub category

Rev. D
7.3.5.5 Sub Category Control Material
Figure 7-13: Sub Category Control Material

Rev. D
Accuracy The accuracy values for a control may vary depending on the assay the control is being used with.
values for This data grid displays a list of all assays the control is associated with and their relevant accuracy
control material values.
It also allows the user to link the control with a new assay and create the accuracy values for that
assay
Bar Code Shows the bar code used for selected control material
Cancel Will reset the values, if a control has been selected from the drop down list, the details of that
control will be re-set. This cannot happen after details have been saved.
Control Material List containing all available controls. If the user selects a control, the details associated with that
control are populate in the fields below.
If the user selects [New Control.] the fields mentioned below will be left blank.
Expiry Date Shows the expiry date of the control.
Lot Number Shows the lot number of the control material
Manufacturer Shows the name of the controls manufacturer.
Matrix Shows the matrix of the control material.
Name Shows the name of the selected control or of the new control.
Save Saves the new control or the changes to the existing control in the database.
Table 7-19: Functions of the Control Material sub category

Rev. D
7.3.5.6 Sub Category Period
The Period tab allows you to select a period based on its date/time and view its details. Upon select, the Analyzer, Assay, Control Material,
Start Date and Period comments will be displayed to the user.
Figure 7-14: Sub Category Period

Rev. D
Analyzer This drop down list contains a list of available analyzers, one of which the selected period will or
does use.
Assay This drop down list contains a list of available assays, one of which the selected period will or does
use.
Cancel Will reset the values, if a period has been selected from the drop down list, the details of that
period will be re-set. This cannot happen after details have been saved.
Comments Displaying any comments the user or the system may have added when editing the period.
Control Material This drop down list contains a list of available control materials, one of which the selected period
will or does use.
Save Saves the new period or the changes to the existing period in the database.
Select Period Displays a list of period by their start date. On selecting a period, the detail relating to that period
will be displayed in the following fields. If the user is selecting to edit a period, they cannot edit the
Analyzer, assay, control material or start date.
Start Date Displays the date and time the period started or starts.
Table 7-20: Functions of the Period sub category

Rev. D
7.3.5.7 Sub Category Result
Here, the user only has the ability to add new results to an existing period. The ability to edit a result is done from the main results screen, and
only results that have been manually entered can be edited.
Figure 7-15: Sub Category Result

Rev. D
Analyzer Shows a list of all the available analyzers a result can be tested on.
Assay Shows a list of all the available assays a result can be for.
Cancel Will reset the values all back to nothing.
Comments Field to enter any comments on the result.
Concentration Field to enter the actual result (concentration values and unit)
Value & Unit
Control Material Shows a list of all the available control materials a result can be.
Evaluation Drop down list to select pass or fail as the result evaluation.
Result
Lab Shows a list of all available laboratories a result can be tested in.
Plate ID Field to enter the plate ID.
PrecAcc Selecting as to whether this result is to be compared against Precision or Accuracy
Result Date This is a facility to allow the user to select the date the result was taken.
Result ID A unique ID for the result.
Save Saves the new result to the database.
Table 7-21: Functions of the Result sub category

Rev. D
7.3.6 Main Category Audit

The application provides a mechanism for users to be able to view audit trails as per the regulatory requirements. An audit trail entry will be
written at the least during the creation, modification, maintenance and deletion of entries.
Figure 7-16: Main Category Audit

Rev. D
Audit By Dates Start and end date of the shown audit runs.
Between … And
Audit by user Name of the user who has made changes.
Export Audit Allows the user to export the audit log to a file based format (.csv).
Filter by Date Filters the shown entries by date.
Print Audit Allows the user to print the audit log straight to a printer.
Run Audit Shows the audit entries for the selected user and date.
Table 7-22: Functions of the Audit main category
Column Description
User Name Name of the user, who changed an entry.
Created On Shows the date when the change was made.
Action Shows the changes.
Property Property of the entry.
From Original value.
To New value.
Table 7-23: Columns of the Audit table

Rev. D
7.3.7 Main Category Administration
7.3.7.1 Sub Category User
Figure 7-17: Sub Category User

Rev. D
< Clear a selected role away from the User Roles list.
<< Clear all roles away from the User Roles list.
> Assign a selected role in the Available Roles list to the User Roles list.
>> Assign all roles in the Available Roles list to the User Roles list.
Available Roles Shows a list of all available roles (set of access rights).
Cancel Will reset the user data, if a user has been selected from the drop down list, the details of that user
will be re-set. This cannot happen after details have been saved.
Confirm Field to retry the new password.
Password
Delete Delete selected user.
Password Field for a new password.
Any alphanumeric chain of characters can be used as password. The password is case sensitive.
Save Saves the changed or new user data to the database.
Select User Drop down list with all available users.
User Name Shows a user name or enables to add a new user name.
User Roles Shows a list of all roles (set of access rights) for the user.
Table 7-24: Functions of the User sub category
This page is available only after login from the Desktop Shield

Rev. D
7.3.7.2 Sub Category Roles
Figure 7-18: Sub Category Roles

Rev. D
< Clear a selected feature away from the Features for Role list.
<< Clear all features away from the Features for Role list.
> Assign a selected feature in the Available Features list to the Features for Role list.
>> Assign all features in the Available Features list to the Features for Role list.
Available Shows a list of all available features (access rights).
Features
Cancel Will reset the role, if a role has been selected from the drop down list, the details of that role will be
re-set. This cannot happen after details have been saved.
Features for Shows a list of all features (access rights) for the role.
Role
Role Name Shows a role name or enables to add a new role name.
Save Saves the changed or new role to the database.
Select Role Drop down list with all available roles.
Table 7-25: Functions of the Roles sub category
This page is available only after login from the Desktop Shield

Rev. D
7.3.7.3 Sub Category Archive Data
The sub-category Archive data allows user to export the information related to closed periods. Once the selected closed periods have been
archived, they will not be present in the Results main category page. However, the user can restore those periods via the Retrieve Archived
Periods section, as shown in Figure 7-19. The closed periods can be archived to and retrieved from an external storage device.
Figure 7-19: Sub Category Archive Data

Rev. D
Archive Periods Function Description

Group
Archive periods Start and end date of the archive periode.
started between
… and
Run Archive Starts the archiving process.
Table 7-26: Functions of the Archive Periods group
Retrieve Archive Function Description

Periods Group All Files Uses all files for the retrieve process.
Archive File Shows the location of the archive files.
Location
List Shows all archive files in the selected archive file location.
Only Selected Uses only the selected files for the retrieve process.
Files
Retrieve Starts the retrieve process.
Archive
Table 7-27: Functions of the Retrieve Archive Periods group

Rev. D
8 Maintenance
8 Maintenance
In order to operate correctly, it is essential that the LIAISON®XL system is maintained in accordance with the maintenance plan and
procedures described in the instrument software.
According to given scheduling the system prompts the user for due maintenance tasks, and it guides the user through the required procedure.
Carefully observe all required steps in order to ensure proper system functionality.
8.1 Safety and Hints
See Electrical safety in chapter 1.8.3.

Rev. D
8 Maintenance
Improper MaintenanceActions
Improper maintenance Actions can result in serious personal injuries and material damage
 Follow all safety instructions in chapter 1.8 and this chapter.
 Follow the work instructions stated by the software.
 Take off watches and jewellery before performing any maintenance works.
Unapproved Maintenance Actions

Unapproved or inaccurately performed maintenance actions can result in serious personal injury and material
damage.
 Only perform maintenance actions stated by the software.
 Follow closely the steps contained in the individual instructions.
 For the maintenance actions, only use parts or reagents mentioned in this instruction.
 Tests and maintenance actions specified by the manufacturer must be performed to ensure the safe operation of
the system and the proper functioning of the system.
 All service and maintenance actions which are not described in this instruction must be performed by qualified
and authorized service technicians.
 Any changes made to the instrument that are not authorized by the manufacturer will lead to the loss of
guarantee.

Rev. D
8 Maintenance
Handling of Decontamination Products

 Pay attention in managing the decontamination products, because they may be harmful. Read the instructions of
the decontamination products before use.
 Do not mix sodium hypochlorite solution (e.g. bleach) with alcohol or any other flammable.
 Observe the proper dilution of chemicals,as stated by the SW.
Danger of Electrocution or Mechanical Injury during Required Maintenance Works on the Voltage-Carrying
System
If the system cannot be separated from the mains supply during required maintenance works, additional precautions
must be taken to avoid serious injury with lethal consequences due to electrocution or injury by the system (e.g.
contusion, cuts etc.).
 Only switch on the system if this is explicitly required.
 Only explicitly described protective covers may be opened.
 Perform the maintenance works with highest caution.
 Never touch electrical connecting contacts.
 Please note that mechanical components (e.g. pipettor) can move unexpectedly.
Disposal
The instrument, the packaging material, and all parts that have been replaced must be disposed according to the
applicable local and national provisions, legislation and laboratory procedures.

Rev. D
8 Maintenance
Cleaning, Disinfection or Decontamination

Observe the following aspects during cleaning, disinfection or decontamination because breakdowns or damages
can be the result.
 Liquid cleaning, disinfection or decontamination solutions may only be used with a moistened cleaning tissue.
They may not be poured into or sprayed into the system.
 Only cleaning, disinfection or decontamination solutions and procedures stated by the software are approved.
 Cleaning, disinfection or decontamination solutions must not come into contact with bearings and guides, as
otherwise the greasy film may dissolve!
 Cleaning, disinfection or decontamination solutions must not be used in the vicinity of circuit boards, light barriers
and perspex surfaces!

Rev. D
8 Maintenance
Unsuitable Sterilisation Method

Containers and components for liquids or waste are seriously damaged by autoclaving.
 Disinfect or decontaminate the containers and components with a suitable disinfection or decontamination
method.
 Comply with procedures stated by the software.
 Disposable materials must be incinerated.
 Liquid waste must be decontaminated with a chemical use sodium hypochlorite solution with 0.1% active chlorine
(e.g. dilution 1:50 of a solution at 5% active chlorine) for at least half an hour.
Handling/Cleaning of Optic Surfaces

Optic surfaces (e.g. scanners, lenses, sensors) must be free of dust and grease.
 Do not touch any optic surfaces.
 Only clean the optic surfaces with a softy and lint-free cloth.
 Do not use any aggressive detergents (e.g. acetone).
Touch Screen Cleaning

Improper cleaning could damage the touch screen surface.
 Use soft clothes with neutral detergent or with ethanol to clean the touch screen.
 Do not use any chemical solvent, acidic or alkaline solution.
 Do not allow liquid from soaking into the joint of film and glass which may result in peeling or malfunctioning.

Rev. D
8 Maintenance
Organic Solvents
Reagent containers and hoses (water and waste) can be seriously damaged by or become unusable because of
organic solvents.
 Never use organic solvents.
8.2 Scheduled Maintenance Tasks
LIAISON®XL system takes care of informing about the need of a maintenance task (see chapter 6.9). Please perform the scheduled
maintenance tasks as requested. Please consult the following sections for procedures.
Local service support may perform or be required to perform maintenance tasks that may be necessary for specific purposes (e.g.
troubleshooting).
Local service support is allowed to perform preventive maintenance according to DiaSorin procedures.
8.3 Light Check
The Light Check (part number 319101) is a DiaSorin product, intended to be used on the LIAISON®XL system in a dedicated maintenance
task only with the purpose of troubleshooting.
Light Check reagent contains a lyophilized material that, when mixed with the proper amount and type of water, issues a predetermined RLU
value when run on the LIAISON®XL system. It is required when running a system test on the system.
Please comply with the storage and manufacturer's directions included in the package information for the Light
Check.

Rev. D
8 Maintenance
8.4 Preparation of Liqui-Nox® solution
Before Liqui-Nox® solution is handled or loaded into the LIAISON®XL system, the package information of Liqui-Nox®
is to be read thoroughly and followed by the user.
The execution of some maintenance procedures foresees the use of a Liqui-Nox® solution (code X0022) that shall be prepared according to
the procedures reported below.
Instruction to prepare 1 L of 1% Liqui-Nox® solution:

1. Fill the cleaning solution bottle with 10 mL of Liqui-Nox® detergent;
2. Add 0.99 L of water ;
3. Place the proper cap and gently shake the container, in order to limit the formation of foam.
8.5 Load and Unload the Cleaning Solution Bottle
Before starting each weekly or monthly maintenance task, 1 L of fresh Liqui-Nox® solution shall be prepared
according to chapter 8.4.
Unload 1. Open the cabinet (see chapter 4.1.5).

Procedure 2. Disconnect the tube of the cleaning solution bottle from the cap (Figure 8-1Errore. L'origine riferimento non è stata trovata.).
3. Pull the cleaning solution bottle out of the LIAISON®XL system.
4. Remove the cap of the cleaning solution bottle.
Use a vessel and paper towels to avoid liquid spills.

Rev. D
8 Maintenance
Load Procedure 1. Place the cap on the full cleaning solution bottle.
2. Put the cleaning solution bottle into the LIAISON®XL system.
3. Reconnect the tube to the cap of the cleaning solution bottle.

Procedure 2. Pull left cabinet drawer out.
3. Disconnect the tube of the cleaning solution bottle from the cap (Figure 8-1Errore. L'origine riferimento non è stata trovata.).
Figure 8-1: Disconnect cleaning solution bottle
4. Pull the cleaning solution bottle out of the dedicated slot of the waste basin (Figure 8-2Errore. L'origine riferimento non è stata
trovata.).

Rev. D
8 Maintenance
5. Remove the cap of the cleaning solution bottle.

Use a vessel and paper towels to avoid liquid spills.
Figure 8-2: Remove cleaning solution bottle

Rev. D
8 Maintenance
Load Procedure 1. Place the cap on the full cleaning solution bottle.
2. Put the cleaning solution bottle into the dedicated slot of the waste basin (Figure 8-3Errore. L'origine riferimento non è stata trovata.).
Figure 8-3: Cleaning solution bottle slot
3. Reconnect the tube to the cap of the cleaning solution bottle (Figure 8-4).

Rev. D
8 Maintenance
Figure 8-4: Cleaning solution bottle reconnection
4. Push the left drawer back into the cabinet.


Rev. D
8 Maintenance
8.6 Clean the pipettor probes
Right and Left probes shall be cleaned during the execution of both weekly and monthly maintenance procedures, as indicated by a dedicated
pop-up that appears during the execution of the tasks.
The following procedure shall be executed to complete the cleaning:
1. Quit the Main UI;
2. Switch off the instrument and disconnect it from the main supply;
3. Open the top cover and move the right arm to a position easy to access;
4. Wipe the right arm probe with a tissue soaked with a Liqui-Nox® solution prepared according to chapter 8.4;
5. Wipe the right arm probe with a tissue soaked with DI water;
6. Wipe the right arm probe with a dry tissue;
7. Move the left arm to a position easy to access;
8. Wipe downward the left arm adapter with a tissue soaked with a Liqui-Nox® solution prepared according to chapter 8.4;
9. Wipe downward the left arm adapter with a tissue soaked with DI water;
10. Wipe downward the left arm adapter with a dry tissue;
11. If all the required cleaning procedures have been completed, reconnect the instrument to the main supply and switch it on, otherwise
continue with the execution of the other cleaning procedures.

Rev. D
8 Maintenance
8.7 Clean the analyzer interior
Some of the inner parts of the analyzer shall be cleaned during the execution of the monthly maintenance procedure, as indicated by a
dedicated pop-up that appears during the execution of the task.
3. Open the sample area flap and extract the available sample racks;
4. Once removed the sample tubes, wipe each rack with a tissue soaked with an alcoholic/disinfectant solution;
5. Wipe the surfaces of the sample module with a tissue soaked with an alcoholic/disinfectant solution;
6. Push the sample racks back into the sample area and close the flap;
7. Open the reagent area flap and extract the ancillary plate;
8. Wipe the surfaces of the ancillary plate with a tissue soaked with an alcoholic/disinfectant solution;
9. Wipe the accessible surfaces of the reagent area (i.e. the surface where lane numbers are indicated) with a tissue soaked with an
alcoholic/disinfectant solution;
10. Push the ancillary plate back into the reagent area and close the flap;
11. Open the starter reagent area flap;
12. Remove the starter bottles;
13. Wipe the surfaces of the starter reagent area with a tissue soaked with an alcoholic/disinfectant solution;
14. Insert starter bottles back into the starter reagent area;

Rev. D
8 Maintenance
8.8 Clean the primary and the intermediate tanks
Tanks and intermediate tanks containing water and wash solution shall be cleaned during the execution of the monthly maintenance
procedure, as indicated by a dedicated pop-up that appears during the execution of the task.

3. Open the cabinet right and middle doors;
4. Pull the water tank (blue cap) out and dispose the liquid;
5. Pull the wash solution tank (white cap) out and dispose the liquid;
6. Remove the water intermediate tank (6);
7. Disconnect the liquid (4) and the sensor (5) connectors from the cap of the intermediate tank;
8. Remove the wash solution intermediate tank (3);
9. Disconnect the liquid (1) and the sensor (2) connectors from the cap of the intermediate tank;
10. Remove the black cap of the water intermediate tank and dispose the liquid;
11. Remove the black cap of the wash solution intermediate tank and dispose the liquid;
12. Fill all tanks and intermediate tanks with 1 L of Liqui-Nox® solution prepared according to chapter 8.4;
13. Close all the tanks with the dedicated caps;
14. Gently shake each tank, avoiding spilling and limiting the formation of foam;
15. Empty carefully each tank and rinse it thoroughly with distilled water (to ensure an adequate rinsing, it is recommended to fill each tank at
least at half volume). Water to be used has to be defined according to CLSI guidelines for laboratory water (“Instrument Feed Water”
type);
16. Repeat the previously operation at least two more times for each tank and verify the foam has been completely removed;

Rev. D
8 Maintenance
17. Screw the caps of intermediate tanks;

18. Reconnect liquid and sensor connectors to both intermediate tanks;
19. Reinstall intermediate tanks avoiding swapping of the two of them;
20. Fill the water tank with DI Water, screw the cap and load it into the system;
21. Fill the wash tank with the dedicated solution, screw the cap and load it into the system;
22. Wait approximately 5-10 minutes in order to allow the filling of the intermediate tanks;
Figure 8-5: Intermediate tanks removal

Rev. D
8 Maintenance
For the preparation of the wash solution, refer to the Instruction for Use available in system liquid packages. Use the
red line available on the tank as help during the preparation of the wash solution (refer to chapter 1.10.9).

Preliminary 1. Quit the Main UI.
steps
2. Switch off the instrument and disconnect it from the main supply.
Wash buffer 3. Open the cabinet right and middle doors.

tanks removal 4. Pull the right drawer out of the cabinet.
5. Remove the wash buffer main tank (white cap) and dispose the liquid.

Rev. D
8 Maintenance
6. Remove the sponge placed in front of the intermediate tank (Figure 8-6).
Figure 8-6: Sponge removal

Rev. D
8 Maintenance
7. Disconnect sensor (b) and liquid (a) connectors from the intermediate tank (Figure 8-7).
Figure 8-7: Wash buffer intermediate tank connectors

Rev. D
8 Maintenance
8. Using the handle, move the intermediate tank to the front (Figure 8-8).
Figure 8-8: Wash buffer intermediate tank moved to the front

Rev. D
8 Maintenance
9. Raise the intermediate tank up (Figure 8-9) and remove it from the dedicated slot of the drawer.
Figure 8-9: Wash buffer intermediate tank raised up and removed
10. Remove the black cap of the wash buffer intermediate tank and dispose the liquid.

Rev. D
8 Maintenance
Water tanks 11. Remove the water main tank (blue cap) and dispose the liquid.
removal 12. Remove the sponge placed in front of the intermediate tank (Figure 8-10).
Figure 8-10: Sponge removal

Rev. D
8 Maintenance
13. Disconnect sensor (b) and liquid (a) connectors from the intermediate tank (Figure 8-11).
Figure 8-11: Water intermediate tank connectors

Rev. D
8 Maintenance
14. Using the handle, move the intermediate tank to the front (Figure 8-12).
Figure 8-12: Intermediate tank moved to the front

Rev. D
8 Maintenance
15. Raise water intermediate tank up (Figure 8-13) and remove it from the dedicated slot of the drawer.
Figure 8-13: Intermediate tank raised up and removed
16. Remove the black cap of the water intermediate tank and dispose the liquid.

Rev. D
8 Maintenance
Tanks cleaning 17. Fill all tanks and intermediate tanks with 1 L of Liqui-Nox® solution prepared according to chapter 8.4.
18. Close all the tanks with the dedicated caps.
19. Gently shake each tank, avoiding spilling and limiting the formation of foam.
20. Empty carefully each tank and rinse it thoroughly with distilled water (to ensure an adequate rinsing, it is recommended to fill each tank at
least at half volume). Water to be used has to be defined according to CLSI guidelines for laboratory water (“Instrument Feed Water”
type).
21. Repeat the previously operation at least two more times for each tank and verify the foam has been completely removed.
22. Screw the caps of intermediate tanks.
Water Tanks 23. Place the water intermediate tank into the dedicated slot of the drawer.
insertion 24. Holding the drawer by hand, push the intermediate tank back to the end of the slot (Figure 8-14).

Rev. D
8 Maintenance
Figure 8-14: Water intermediate tank insertion
25. Connect liquid and sensor connectors to the intermediate tank (Figure 8-11).

Rev. D
8 Maintenance
26. Put the sponge in front of the intermediate tank (Figure 8-15).
Figure 8-15: Sponge placement
27. Fill the water tank with DI Water, screw the cap and load it into the system.

Rev. D
8 Maintenance
Wash Buffer 28. Place the wash buffer intermediate tank into the dedicated slot of the drawer.
Tanks insertion 29. Holding the drawer by hand, push the intermediate tank back to the end of the slot (Figure 8-16).
Figure 8-16: Wash buffer intermediate tank insertion
30. Connect liquid and sensor connectors to the intermediate tank (Figure 8-7).
31. Put the sponge in front of the intermediate tank (Figure 8-17).

Rev. D
8 Maintenance
Figure 8-17: Sponge placement
32. Fill the wash buffer tank with the dedicated solution, screw the cap and load it into the system.
For the preparation of the wash solution, refer to the Instruction for Use available in system liquid packages. Use the
red line available on the tank as help during the preparation of the wash solution (refer to chapter 1.10.9).
33. Push the right drawer back into the cabinet.

35. Wait approximately 5-10 minutes in order to allow the filling of the intermediate tanks.

Rev. D
8 Maintenance
8.9 Clean the covers
Covers and flaps of the analyzer, together with also the monitor and the extensible board, shall be cleaned during the execution of the monthly
maintenance procedure, as indicated by a dedicated pop-up that appears during the execution of the task.
2. Switch off the instrument and disconnect it from the mains supply;
3. Wipe the external side of the covers (top covers, side covers, front covers) with a tissue soaked with an alcoholic/disinfectant solution;
4. Open reagent, sample, starter and cabinet flaps and wipe them (internally and externally) with a tissue soaked with an
alcoholic/disinfectant solution;
5. Wipe the extensible board with a tissue soaked with an alcoholic/disinfectant solution;
6. Wipe the monitor with a tissue soaked with an alcoholic/disinfectant solution;
8.10 Cuvette removal
In case one or more cuvettes should result as blocked in the accessible cuvette transportation system, it is possible to manually remove
completely the blocked cuvettes (the software would prompt a corresponding event).
The following procedure shall be executed to complete the removal:
1. Pause the pipettors from the STOP Menu
2. Wait for 30’’
3. Open the main cover
4. Remove the blocked cuvettes and throw them away

Rev. D
8 Maintenance
5. Close the main cover

6. Restart the pipettors from the STOP Menu
Never open the main cover without having paused the pipettors.
8.11 Automated actions performed by the system
The system automatically performs the following actions overnight, in order to improve the system performance:
 initialization
 automated back-up and clean-up of archived results from the Archived menu
provided that it was active and in status “Stand-by” when due.
Systems working overnight

In case the system works overnight without significant interruptions, the automatic initialization could not be
performed. It is possible to check in the Event Log when the last initialization occurred.
In case the system could not automatically perform the scheduled initialization, it is necessary to initialize the system
manually before starting a new routine.

Rev. D
9 Troubleshooting and Error Messages
9.1 Error Messages and Information Messages
This chapter describes error messages or information messages and gives instruction on error recovery.
If the error reoccurs, please call service.
The system may automatically reschedule replicates failed for a reason that could be recovered without user
intervention.
Legend
Meaning
Parameters Some error messages show details about the error. With this information, the cause or the affected
[…] sample may be found. In the error list (see below) these details will be shown as parameters (e.g.
[SID]).
Example:
 List entry:
Aborted Job [SID] [assay abbreviation] ([replicate]). Reason: Agitation speed out of range.
 Message:

Rev. D
Meaning
Aborted Job SAMPLE_12 APF (2). Reason: Agitation speed out of range.
Effect Depending on the fault category, the error will be noted differently.
In the error list (see below) the notification will be shown in the column effect.
 L: Adds an entry to the event log.
 M: Shows a Message
 S: Sounds a acoustic signal
Software Message Description Action Effect Event ID

Messages
Aborted Job [SID] [assay Agitation speed is  Start the job LMS 262.003.00001
abbreviation] ([replicate]). out of range. again.
Reason: Agitation speed
out of range.  If error
reoccurs, call
service to
check the
LIAISON®XL
system.
Aborted Job [SID] [assay Ancillary is not  Load the LMS 262.009.00001
abbreviation] ([replicate]). present. required
Reason: Ancillary not ancillary
present. reagent.
 Start the job
again.

Rev. D
Message Description Action Effect Event ID

Aborted Job [SID] [assay There is a clot in the  Check the LMS 262.136.00001
abbreviation] ([replicate]). sample probe/tube. sample.
Reason: Clot in Sample
Possible causes:  Check, if
Probe.
 Deficient correct
sample tube/rack
preparation were used.
 Incorrect  Start the job
tracking due to again.
wrong sample
rack type  If error
reoccurs, call
 Incorrect service to
tracking due to check the
wrong tube teaching.
diameter
 Tip touches the
(wet) wall of a
tube.
Aborted Job [SID] [assay There is a clot in the  Check the LMS 262.137.00001
abbreviation] ([replicate]). reagent bottle/tube. reagent.
Reason: Clot in Reagent
Possible causes:  Exchange the
Probe.
 Deficient reagent.
reagent
preparation or  Start the job
storage. again.
 Tip touches the  If error

(wet) wall of a reoccurs, call
bottle/tube. service to
check the
teaching.

Rev. D

Aborted Job [SID] [assay An internal error  Call service LMS 262.016.00001
abbreviation] ([replicate]). has occurred.
Reason: Cycle Type
(Normal, Diluent) Conflict.
Aborted Job [SID] [assay No more disposable  Load LMS 262.007.00001
abbreviation] ([replicate]). tips are available or disposable
Reason: Disposable tip found. tips.
not present.
 Start the job
again.
Aborted Job [SID] [assay The starter paused  Start the job LMS 262.001.00002
abbreviation] ([replicate]). too long. The starter again
Reason: First Starter Shot. shot volume could
be too small.
Aborted Job [SID] [assay Dirty Reader or  Call service. LMS 262.000.00004
abbreviation] ([replicate]). hardware defect.
Reason: High
Background.
Aborted Job [SID] [assay The incubator  Note the LMS 262.013.00001
abbreviation] ([replicate]). temperature is out Conditioning
Reason: Incubator of range. time of 1 hour
temperature out of range. after power-
up.
 Start the job
again.
 If error
reoccurs, call
service to
check the
incubator.

Rev. D

Aborted Job [SID] [assay An internal error  Call service. LMS 262.255.00001
Reason: Internal Error.
Aborted Job [SID] [assay A job scheduling  Start the job LMS 262.017.00001
abbreviation] ([replicate]). error has occurred. again.
Reason: Job Scheduling
Failure.
Aborted Job [SID] [assay Possible causes:  Fill wash LMS 262.005.00001
abbreviation] ([replicate]). buffer
Reason: Liquid Container  Wash buffer
container or
empty. container or
water
water container
container.
empty.
 Check
 Problems with
connectors.
the
container/instru  If error
ment reoccurs, call
connectors. service.
Aborted Job [SID] [assay Error in Reader.  Call service. LMS 262.003.00002
abbreviation] ([replicate]).
Reason: Reader detected
spikes.

Rev. D

Aborted Job [SID] [assay A mechanical error  Check LMS 262.001.00001
abbreviation] ([replicate]). has occurred. LIAISON®XL
Reason: Mechanical Error. system about
jammed
cuvettes or
disposable
tips.
 If possible,
start job
again.
 Call service to
repair the
LIAISON®XL
system.
Aborted Job [SID] [assay There are no more  Load LMS 262.004.00001
abbreviation] ([replicate]). cuvettes available. cuvettes.
Reason: No cuvette
available.  Start the job
again.
Aborted Job [SID] [assay The sample is not  Load sample. L M S 262.134.00001
abbreviation] ([replicate]). loaded or the tube
Reason: No Sample is empty.  Start the job
again.
Aborted Job [SID] [assay The reagent is not  Load reagent. L M S 262.135.00001
abbreviation] ([replicate]). loaded or the bottle
Reason: No Reagent. is empty.  Start the job
again.
Aborted Job [SID] [assay The assay  If error LMS 262.002.00002
abbreviation] ([replicate]). procedure was not reoccurs, call
Reason: No Mitigation completed. service.
Wash.

Rev. D

Aborted Job [SID] [assay An unidentified error  Call service. LMS 262.254.00001
Reason: Not Defined
Error.
Aborted Job [SID] [assay The pipettor is  Close cover. LMS 262.002.00001
abbreviation] ([replicate]). offline
Reason: Pipettor offline.  Click on the
Possible causes: Continue
button.
 Cover opened.
 OLV failure or
 Pause button
problems with
pressed.
the cover: call
 Optical liquid service.
verification
(OLV) aborted.
Aborted Job [SID] [assay The integral is not  Load integral. L M S 262.010.00001
abbreviation] ([replicate]). recognized.
Reason: Reagent Integral  Start the job
not present. again.
 If error
reoccurs, call
service.

Rev. D

Aborted Job [SID] [assay The temperature of  Note the LMS 262.014.00001
abbreviation] ([replicate]). the reagent loading Conditioning
Reason: Reagent bay is out of range. time of 1 hour
up.
 Start the job
again.
 If error
reoccurs, call
service to
check the
reagent
loading bay.
Aborted Job [SID] [assay Reagent not  Call service. LMS 262.131.00001
abbreviation] ([replicate]). pipetted.
Reason: Reagent not
pipetted.
Aborted Job [SID] [assay A reagent integrity  Check LMS 262.133.00001
abbreviation] ([replicate]). error occurred. reagent.
Reason: Reagent Integrity
Possible causes:  No reagent
Error.
problems, call
 Foam on the
service to
reagent liquid.
check
 Not enough teaching and
reagent liquid. hardware.
 Bad teaching.
 Hardware
defect.

Rev. D

abbreviation] ([replicate]). loaded.
Reason: Sample not  Start the job
present. again.
abbreviation] ([replicate]). pipetted
Reason: Sample not  Start the job
Possible causes: again.
pipetted.
 Sample rack  No sample
removed while problems, call
running. service.
 An internal error
has occurred.
Aborted Job [SID] [assay A sample integrity  Check LMS 262.132.00001
abbreviation] ([replicate]). error occurred sample.
Reason: Sample Integrity
Possible causes:  No sample
Error.
problems, call
 Foam on the
service to
sample liquid.
check
 Not enough teaching and
sample liquid. hardware.
 Bad teaching.
 Hardware
defect.

Rev. D

Aborted Job [SID] [assay The temperature of  Note the LMS 262.015.00001
abbreviation] ([replicate]). the starter reagents Conditioning
Reason: Starter Reagent area is out of range. time of 1 hour
up.
 Start the job
again.
 If error
reoccurs, call
service to
check the
area for
starter
reagents.
Aborted Job [SID] [assay An internal error  Call service. LMS 262.011.00001
Reason: Timing violation.
Aborted Job [SID] [assay During disposable  Start the job LMS 262.128.00001
abbreviation] ([replicate]). tip pick up the again.
Reason: Tip pickup failed. disposable tip
adapter reached the  If error
lower position and reoccurs, call
the tip sensor service to
detects a tip, but the check the
pick-up force was teaching.
not as high as
expected.
Aborted Job [SID] [assay Only information. - LMS 262.018.00001
abbreviation] ([replicate]).
Reason: User Requested
Abort.

Rev. D

Aborted Job [SID] [assay Both waste  Empty the LMS 262.006.00001
abbreviation] ([replicate]). containers are full waste
Reason: Waste container or one waste container(s)
full. container is full and
the other one is not
present.
Aborted Job [SID] [assay A washer aspiration  The job is LMS 262.012.00001
abbreviation] ([replicate]). error is occurred. repeated
Reason: Washer automatically.
Aspiration Failure.
 If error
reoccurs, call
service.
AM denied Assay [assay An internal error  Call service. LMS 265.001.00010
abbreviation] for Lane has occurred.
[lane number], Reason:
Method Sequence garbled
AM accepted Mitigation Only information - L 262.000.00032
Wash [Mitigation name] at
cycle [start Cycle], phase
[Start Phase] from
Position [Ancillary
position]
AM denied PipSequence An internal error  Call service. LMS 265.001.00011
[pipettor sequence has occurred.
number], Reason: [reason
number] ([reason
enumeration])

Rev. D

AM rejected Job [SID] A scheduling error  Call service. LMS 262.004.00011
[assay abbreviation] has occurred.
([replicate]) (Cycle
occupied)
AM rejected Job [SID] The ancillary is  Load LMS 262.015.00011
[assay abbreviation] removed during the ancillary.
([replicate]) (Ancillary not run.
present)  Create and
start job
again.
AM rejected Job [SID] An internal error  Call service LMS 262.001.00011
([replicate]) (Assay data
not stored)
([replicate]) (Data garbled)
([replicate]) (Diluent
Volume Out of Range)
([replicate]) (Dilution
PipSeq not stored)
([replicate]) (Ext Reag
Identifier Unknown)

Rev. D

([replicate]) (Invalid
Sample Type)
Reagent Position)
Sample Position)
([replicate]) (Job Memory
full)
([replicate]) (No Ext Reags
!= No Ext Reags by
Assay)
AM rejected Job [SID] The integral is  Load integral. L M S 262.013.00011
[assay abbreviation] removed during the
([replicate]) (Reagent run.  Create and
Integral not present) start job
again.
AM rejected Job [SID] The sample is  Load sample. L M S 262.014.00011
[assay abbreviation] removed during the
([replicate]) (Sample Rack run.  Create and
not present) start job
again.

Rev. D

([replicate]) (Too late)
([replicate]) (too many
reagents)
([replicate]) (Too many
Cuvettes)
AM rejected Job [SID] An internal error  Instrument LMS 262.016.00011
[assay abbreviation] has occurred not initialised:
([replicate]) (Wrong Initialise the
Analyzer State) instrument. If
error
reoccurs, call
service.
 Instrument
initialised: call
service.
Ancillary [ancillary name] The stability of the  Replace the LMS 256.001.00015
in position [lane] expired ancillary reagent is ancillary
expired. reagent.
Ancillary [ancillary name] The (OnBoard)  Replace the LMS 256.001.00016
in position [lane]:OnBoard stability of the ancillary
Stability expired ancillary reagent is reagent.
expired.

Rev. D

Aspirated [reagent] Only information. - L 262.000.00014
Aspirated [reagent] for Job Only information. - L 262.000.00016

[SID] [assay abbreviation]
([replicate]) (JobID [job
ID], Cycle [pipetting cycle])
AspirationPlausibilityError Error occurred  Call service. L 262.000.00022
for Job ([SID] [assay during a run.
abbreviation] ([replicate])),
Job invalidated
Assay [assay The used integral  Use an other L M S 265.000.00016
abbreviation] for Integral needs another version of the
in lane [lane number] has version of the assay assay
wrong Version definition. definition.
or
 Use an other
integral.
BGW was run with result: The background  If error L 270.001.00002
Failed. Measured RLU: maintenance task is reoccurs, call
[Rlu value]. Mean:[Mean failed service.
value] . CV:[CV value]%.
BGW was run with result: Only information. - L 270.001.00001
Passed. Measured
RLU:[RLU value].
Mean:[Mean value].
CV:[CV value]%.

Rev. D

Calibration can not be External calibrator  Load the LS 264.002.00003
started because external for the calibration is external
calibrator "[SID]" is missing. calibrator.
missing
 Start the
calibration
again.
Calibration can not be The internal  Replace the LMS 264.003.00003
started because internal calibrator is empty. integral.
calibrator is exhausted
 Start a new
calibration for
this integral.
Calibration Data on Invalid calibration  Rerun the LMS 265.000.00013
Integral [assay for the integral. calibration.
abbreviation] in Lane [lane
number] not valid  Replace the
integral.
 Start a new
calibration for
this integral.
Calibration usable for that While the first  Wait for the L 264.001.00003
lane has already been calibration is end of the
created. running, a second first
calibration has been calibration.
started.
Checksum mismatch for Problems with the  Remove LMS 258.000.00034
flash curve: Received = vessel. vessel.
[checksum received],
calculated = [checksum  If error
calculated] reoccurs, call
service.

Rev. D

Cleaning reagent (article The Cleaning  Load cleaning L M S 270.006.00002
no: [article number]) not reagent is not reagent or set
found in ancillary bay or loaded or it is it online.
set offline. offline.
Control Definition [Control User scanned the  Import assay LMS 259.001.00001
definition name]not bar-code of a definition.
associated to Assay control reagent with
[assay abbreviation] (not hand bar-code
present in Database). scanner for an
unknown assay
definition.
Control Definition denied, Bar-code problems.  Call service. LMS 259.001.00004
wrong structure.
Control Definition for Only information. - L 259.001.00002

[control name] overwritten.
Barcode for Control Only information. - L 259.000.00003

[control name] scanned.
Control Material [control Control sample not  Load control LMS 262.000.00029
sample ID] is missing for loaded. sample.
Control [control name],
Assay [assay
abbreviation]
Cover opened by user User has opened  Close the LMS 258.000.00027
[user name] the cover. cover.
Cuvette clearing was Only information. - L 272.001.00001

requested by user

Rev. D

Cuvette loading was Only information. - L 272.002.00001
requested by user
Cuvettes bag added Only information - L 258.001.00015
Cuvettes counter reset Only information - L 258.000.00015
Cuvettes entering green Only information  . L 258.002.00014

phase
Cuvettes entering red Cuvette supply is  Load LS 258.000.00014

phase almost empty. cuvettes.
Cuvettes entering yellow Cuvette supply is  Load LS 258.001.00014

phase almost empty. cuvettes.
Older [number of deleted Only information. - L 262.000.00034

results] archived Results
were deleted
Deleted all Dilution Only information. - L 256.002.00009
Sequences
Deleted Assay Abr.: Only information. - L 256.000.00009

[abbreviation], ArtN.:
[article number], Country
Code [country code],
Assay Revision [Assay
Revision]

Rev. D

Deleted Control [control Only information. - L 256.001.00009
name]
Deleted Generic Only information. - L 256.003.00009

Sequences
Deleted Rerun Rule[rerun Only information. - L 256.004.00009

name]
Dispensed into Measuring Only information. - L 262.000.00015
Cuvette
Dispensed into Measuring Only information. - L 262.000.00017

Cuvette for Job [SID]
[assay abbreviation]
ID], Cycle [pipetting cycle])
Empty Incubator due to Only information. - LMS 262.000.00018
inconsitent state of AM
and Software
Event Log cleaned up Only information. - L 256.000.00005
automatically ([number of
remaining events] Events
remaining, [number of
deleted events] Events
deleted)
Export Assay Abr.: Only information. - L 256.000.00008
Code [country code]

Rev. D

Export Control [control Only information. - L 256.001.00008
name]
Export Dilution Sequence Only information. - L 256.002.00008

for [sample/diluent],
[volume] µl)
Export Generic Only information. - L 256.003.00008
Sequences
Export Rerun [rerun name] Only information. - L 256.004.00008
External Scanner has Only information. - L 272.005.00001

read: [read value]

Rev. D

Failed to Aspirate The disposable tip  Pick up the L 262.001.00016
[reagent] for Job [SID] has fallen off the dropped tip.
[assay abbreviation] adaptor
([replicate]), Disposable unexpectedly.  Check for
Tip lost (JobID [job ID], possible
Possible causes: contamination
Cycle [pipetting cycle])
.
 Defective tip
 If error
 Insufficient tip
reoccurs, call
pick-up force
service.
due to
excessive
friction inside
the z drive
pick-up force
due to
excessive
flexibility in the
tip tray.
Failed to Aspirate An internal error  Call service L 262.002.00016
[reagent] for Job [SID] has occurred.
([replicate]), Not Executed
(JobID [job ID], Cycle
[pipetting cycle])
Failed to Aspirate The reagent vial is  Check L 262.003.00016
[reagent] for Job [SID] empty. reagent.
([replicate]), No Liquid  If error
(JobID [job ID], Cycle reoccurs, call
[pipetting cycle]) service.

Rev. D

Failed to Aspirate Clots were detected  Check liquid. L 262.008.00016
[reagent] for Job [SID] during the run.
[assay abbreviation]  Check, if
Possible causes: correct tubes
([replicate]), Clot detected
(JobID [job ID], Cycle were used.
 Deficient liquid
[pipetting cycle]) preparation.  If error
reoccurs, call
 Incorrect
service to
tracking due to
check the
wrong rack
teaching.
type.
 Incorrect
tracking due to
wrong tube
diameter.
 Tip touches the
(wet) wall of a
tube.

Rev. D

Failed to Aspirate Clots were  Check liquid. L 262.009.00016
[reagent] for Job [SID] detected during the
[assay abbreviation] run.  Check, if
([replicate]), Integrity Error correct tubes
Possible causes: were used.
(JobID [job ID], Cycle
[pipetting cycle])  Deficient liquid  If error
preparation. reoccurs, call
service to
 Incorrect
check the
tracking due to
teaching.
wrong rack
type.
 Incorrect
tracking due to
wrong tube
diameter.
 Tip touches the
(wet) wall of a
tube.

Rev. D

Failed to Aspirate Clots were detected  Check liquid. L 262.008.00014
[reagent], Clot detected during the run.
 Check, if
Possible causes: correct tubes
were used.
 Deficient liquid
preparation.  If error
reoccurs, call
 Incorrect
service to
tracking due to
check the
wrong rack
teaching.
type.
 Incorrect
tracking due to
wrong tube
diameter.
 Tip touches the
(wet) wall of a
tube.

Rev. D

Failed to Aspirate The disposable tip  Pick up the L 262.001.00014
[reagent], Disposable Tip has fallen off the dropped tip.
lost adaptor
unexpectedly.  Check for
possible
Possible causes: contamination
.
 Defective tip
 If error
reoccurs, call
pick-up force
service.
due to
excessive
friction inside
the z drive
pick-up force
due to
excessive
flexibility in the
tip tray.
Failed to Aspirate Possible causes:  Check liquid. L 262.009.00014
[reagent], Integrity Error
 Foam on the  No liquid
liquid. problems, call
service to
 Not enough
check
liquid.
teaching and
 Bad teaching. hardware.
 Hardware
defect.

Rev. D

Failed to Aspirate The reagent vial is  Check L 262.003.00014
[reagent], No Liquid empty reagent.
Failed to Aspirate There is not enough  Check L 262.004.00014

[reagent], Not enough liquid in the reagent reagent.
Liquid vial.
Failed to Aspirate An internal error  Call service L 262.002.00014
[reagent], Not Executed has occurred.
Failed to Dispense into Problems with the  Start job once L 262.001.00017
Measuring Cuvette for Job liquid level detection again.
[SID] [assay abbreviation] during aspiration.
ID], Cycle [pipetting
cycle]), LLD-Result
Failed to Dispense into Problems with the  Call service. L 262.002.00017
Measuring Cuvette for Job optical liquid
[SID] [assay abbreviation] verification (OLV) or
([replicate]) (JobID [job the pressure check.
ID], Cycle [pipetting
cycle]), Integrity Error
Failed to Dispense into Problems with the  Call service. L 262.002.00015
Measuring Cuvette, optical liquid
Integrity Error verification (OLV) or
the pressure check.
Failed to Dispense into Problems with the  Start job once L 262.001.00015
Measuring Cuvette, LLD- liquid level detection again.
Result during aspiration.

Rev. D

Failed to interpret File [file An error has  Call service. LMS 262.000.00101
failed to interpret] occurred during the
opening file
process.
Failed to load File [file An error has  Call service. LMS 259.000.00100
failed to load] occurred during the
loading file process
Failed to load Rack File The sample rack file  Call service. LMS 265.000.00014
'[file path]' for lane [lane is missed
number].
Failed to store File [file An error has  Check hard LMS 267.001.00100
failed to store] occurred during the disk or USB
storing file process stick capacity
 Call service.
 Call service.
 Call service.

Rev. D

Failed to upload An internal error  Call service. LMS 267.000.00002
Disposable Tip has occurred.
Coordinates !
Failed to upload Integral An internal error  Call service. LMS 265.000.00002
Bay Coordinates ! has occurred.
Failed to upload Sample An internal error  Call service. LMS 264.000.00002

Coordinates ! has occurred.
Font/Color for Result Only information. - LMS 256.000.00012

Label reset while
importing Assay Abr.:
Assay Revision [Assay
Revision]
Forbidden removal of left Only information. - LMS 267.000.00003
DiTiTray
Forbidden removal of right Only information. - LMS 267.001.00003

DiTiTray
Import Generic Only information. - L 256.003.00006

Sequences
Import Assay Abr.: Only information. - L 256.000.00006

Assay Revision: [assay
revision]

Rev. D

Import Control [control Only information. - L 256.001.00006
name]
Import Dilution Sequence Only information. - L 256.002.00006

for [sample/diluent],
[volume] µl
Incomplete flash curve Only information. - LMS 258.000.00031
transmission for block
[block number].
Incubator initialization was Only information. - L 272.000.00003
requested by user
Incubator temperature in Only information. - L 258.001.00004

range
Incubator temperature out Only information. - LS 258.000.00004

of range
Initialization completed. Only information. - L 258.000.00036
Integral [assay The integral loaded  Replace the LMS 256.000.00015

abbreviation] in lane [lane] in that lane is integral
expired expired
Integral [abbreviation] in The OnBoard  Replace the LMS 256.000.00016
lane [lane]: OnBoard Stability of the integral
Stability expired integral loaded in
that lane is expired.
Integral [assay Only information. - L 265.000.00012
abbreviation] removed
from Lane [lane number].

Rev. D

Integral found at lane Only information. - L 265.000.00017
[lane number] with
ArticleNo [Art. No],
LotNo[LotNo], KitNo
[KitNo], rem.
Det.[rem.Determinations],
rem. Calibr[rem.
Calibrations] and LL [LL
values]
Integral removed from Only information. - L 265.001.00012
Lane [assay abbreviation].
Job to schedule does not The job has been  Re-start the LMS 262.000.00013
exist in DB ([SID] [assay deleted from the DB job
abbreviation] ([replicate])) after that the routine
is started
Job to transmit does not The job has been  Re-start the LMS 262.000.00012
exist in DB ([SID] [assay deleted from the DB job
abbreviation] ([replicate])) after that the routine
is started
Left Arm initialization was Only information. - L 272.000.00001
requested by user
Light Check for left arm The Light Check  If error L 270.002.00002
was run with result: Failed. task for left arm is reoccurs, call
Measured RLU: [RLU failed. service.
value]; Mean:[Mean
value]. CV:[CV value] %.

Rev. D

Light Check for left arm Only information. - L 270.002.00001
was run with result:
Passed. Measured
RLU:[RLU value];
Mean:[Mean value].
CV:[CV value]%.
Light Check for right arm The Light Check  If error recurs, L 270.003.00002
was run with result: Failed. task for right arm is call service.
Measured RLU: [RLU failed.
value]; Mean:[Mean value
. CV]: [CV value]%.
Light Check for right arm Only information. - L 270.003.00001
was run with result:
Passed. Measured RLU:
[RLU value]; Mean:[Mean
value] . CV:[CV value]%.
Light Check was run with The Light Check  If error L 270.004.00002
result: Failed. Measured task is failed. reoccurs, call
RLU: left arm: [left arm service.
RLU value]; right arm:
[right arm RLU value].
Mean: left arm [left arm
Mean value], right arm
[right arm Mean value].
CV: left arm [left arm CV
value]%, right arm [right
arm CV value] %.

Rev. D

Light Check was run with Only information. - L 270.004.00001
result: Passed. Measured
RLU: left arm: [left arm
RLU value]; right arm:
[right arm RLU value].
Mean: left arm [left arm
mean value], right arm
[right arm Mean value].
CV: left arm [left arm CV
value]%, right arm [right
arm CV value] %.
Lightcheck reagent (article Only information. - LMS 270.006.00001
no: [article number]) not
found in ancillary bay or
set offline.
Liquid Waste entering Only information. - L 258.002.00012
green phase
Liquid Waste entering red Liquid waste  Empty liquid LS 258.000.00012

phase container is almost waste
full. container.
Liquid Waste entering Liquid waste  Empty liquid LS 258.001.00012
yellow phase container is almost waste
full. container.
Left Liquid Waste Tank Only information. - L 258.001.00013
inserted
Left Liquid Waste Tank Only information. - LMS 258.000.00013

removed

Rev. D

Right Liquid Waste Tank Only information. - L 258.003.00013
inserted
Right Liquid Waste Tank Only information. - LMS 258.002.00013

removed
Loaded Rack File '[rack Only information. - L 265.001.00014

name]' for lane [lane
number].
Loaded the Assay [assay Only information. - L 265.000.00010
abbreviation] for Lane
[lane number]
Maintenance Task Only information. - LMS 270.000.00002
[Maintenance task name]
failed
[Maintenance Task name]
not performed.
Maintenance Task Only information. - L 270.000.00001
succeeded.
[Maintenance Task name]
was cancelled.
Reader initialization was Only information. - L 272.000.00005
requested by user
Mitigation Wash in cycle Only information.  If error LMS 262.001.00037

[cycle], phase [phase] reoccurs, call
failed service

Rev. D

Mitigation Wash in cycle Only information. - L 262.000.00037
[cycle], phase [phase]
performed
Mitigation Wash in cycle Only information. - L 262.000.00038
[cycle], phase [phase],
Reagent [reagent]
performed
Mitigation Wash in cycle Only information.  If error LMS 262.001.00038
[cycle], phase [phase], reoccurs, call
Reagent [reagent] failed service
Moved Job [SID] [assay Only information. - L 262.000.00019
abbreviation] ([replicate])
from [old cuvette position]
to [new cuvette position]
No Assay found for Missing the assay  Load the LMS 265.000.00015
Integral with Article definition in the DB. assay
Number [article number] in definition.
lane [lane number]
No Integral found to Missing the needed  Load the LMS 262.000.00005
schedule Job [SID] [assay integral. needed
abbreviation] ([replicate]). integral.
[reason]
No matching Diluent Missing the dilution  Call service. LMS 262.000.00024
Sequence found for Job sequence.
[SID] [assay abbreviation]
([replicate])

Rev. D

Not all needed resources Missing resources  Refill or load LMS 270.005.00001
for Maintenance are for Maintenance or missing
available, or temperatures the liquid waste resources.
are out of range or waste container is full
containers are full.  Empty liquid
waste
container
OLV Calibration failed Problems with the  Prime the LMS 272.003.00003
optical liquid pipettor
verification (OLV). intensive.
 Call service.
OLV Calibration Only information. - L 272.003.00002
succeeded
OLV Calibration was Only information. - L 272.003.00001

requested by user
Overwrite Assay Abr.: Only information. - L 256.000.00007

[Assay abbr.], ArtN.:
[Art.No ], Country Code
[Country code],Assay
Revision [Assay Revision]
Overwrite Control [control Only information. - L 256.001.00007
name]
Overwrite Rerun [rerun Only information. - L 256.004.00007

name]
Printing Failed Problems with the  Call service. LMS 271.000.00001

printer driver.

Rev. D

Quality Control The QC Software - LM 269.000.00001
[Passed/Failed] for has detected a rule
analyzer [analyzer ID], violation as
assay [Assay abbr.], described.
control name [control
name] at [Date and Time].
The rule type was [rule
type] with the comment:
[comment].
Quality Control The QC Software - LMS 269.001.00001
[Passed/Failed] for has detected a rule
analyzer [analyzer ID], violation as
assay [Assay abbr.], described.
control name [control
name] at [Date and Time].
The rule type was [rule
type] with the comment:
[comment].
Reagent Integral Only information. - L 258.001.00002
temperature in range
Reagent Integral Problems with the  Call service. LS 258.000.00002

temperature out of range reagent loading bay
cooling system.
Check PressureProfiles.txt The pressure profile  Call service. LMS 256.000.00013
Received 0x "01 23 [error file is damaged
code]",
Received checksum for An internal error  Call service. LMS 258.000.00033
flash curve invalid, has occurred
consists of [byte count]
byte.

Rev. D

Received JobId = [job ID] An internal error  Call service. LMS 258.000.00035
is invalid. has occurred
Repeat Job [SID] [assay Only information. - LMS 262.000.00023

abbreviation] ([replicate])
Import Rerun Rule [rerun Only information. - L 256.004.00006

name]
Result of OLV Calibration: Only information. - L 272.003.00004

[Result value]
Right Arm initialization Only information. - L 272.000.00002

was requested by user
RLU received: [RLU] Only information. - L 262.000.00010

([dark count corrected]/
[dark count]) for Job [SID]
([replicate])
Sample Tube for Job to The sample tube is  Load sample LMS 262.000.00021
schedule was removed removed during run. again.
([SID] [assay abbreviation]
([replicate]))
Sample Scanner has Only information. - L 272.004.00001
read: [read value]
Samples temperature in Only information. - L 258.001.00003

range

Rev. D

Samples temperature out Only information. - L 258.000.00003
of range
Scheduled Job [SID] Only information. - L 262.000.00006

([replicate]) for Cycle
[cycle], Lane [integral
lane] (finishes in [finishing
cycle], coordinate [sample
coordinate])
Scheduled Priming Only information. - L 262.000.00027
cuvette for Starterset A,
Startcycle: [start cycle],
Primecycle: [prime cycle]
Scheduled Priming Only information. - L 262.000.00028
cuvette for Starterset B,
Startcycle: [start cycle],
Primecycle: [prime cycle]
Software: Communication An internal error  Restart the LMS 258.000.00028
error. [error string] has occurred. computer and
the
instrument.
Software: Internal An internal error  Restart the LMS 258.000.00030
communication error. has occurred. computer and
[error code] the
instrument.
Software: No serial An internal error  Restart the LMS 258.000.00029
communication to device. has occurred. computer and
[error string] the
instrument.

Rev. D

Solid Waste counter reset Only information. - L 258.000.00018
Solid Waste drawer pulled Only information. - LS 258.000.00017

out
Solid Waste drawer Only information. - L 258.001.00017

pushed in
Solid Waste entering Only information. - L 258.002.00016

green phase
Solid Waste entering red The solid waste  Empty the LS 258.000.00016
phase container is almost solid waste
full. container.
Solid Waste entering The solid waste  Empty the LS 258.001.00016
yellow phase container is almost solid waste
full. container.
Start processing Integral Only information. - L 262.001.00025
Simulation File, Integrals
are not physically present
Start processing Job Only information. - L 262.000.00025
Simulation File, RLU-
Values are not measured
Start processing SLD Only information. - L 262.002.00025
Simulation File, Samples
are not physically present
Starter [A1, A2, B1 or B2] Only information. - L 258.002.00019
entering green phase

Rev. D

Starter [A1, A2, B1 or B2] The starter bottle is  Load a new LS 258.000.00019
entering red phase almost empty. starter bottle.
Starter [A1, A2, B1 or B2] The starter bottle is  Load a new LS 258.001.00019
entering yellow phase almost empty. starter.
Starter [A1, A2, B1 or B2] Only information. LMS 258.000.00021

removed during a run
Starter [A1, A2, B1 or B2] Only information. - L 258.001.00005

temperature in range
Starter [A1, A2, B1 or B2] Problems with the  Call service. LS 258.000.00005
temperature out of range cooling system of
the area for starter
reagents
Starter Bottle [article The starter bottle is  Exchange the L M S 256.002.00015
number.] in position [lane] expired. starter bottle.
expired
Starter Lot Change Only information. - L 262.000.00030
performed, switched
Starter Set [starter set
(A/B)], Starter Reagent
[starter reagent (1/2)] from
Lot [old LOT number] to
Lot [new LOT number]
Starter Priming failed Problems with the  Repeat LMS 262.000.00035
starter priming. priming.
 If error
reoccurs, call
service.

Rev. D

Stopped Analyzer due to An internal error  Call service. LMS 256.000.00010
serious event before has occurred
Switched active liquid Only information. - L 258.000.00037

waste tank from left to
right
Switched active liquid Only information. - L 258.001.00037
waste tank from right to
left
System initialized Only information. - L 256.000.00002
System Liquid entering Only information. - L 258.002.00008

green phase
System Liquid entering The Water  Refill the LS 258.000.00008

red phase container is almost Water
empty. container.
System Liquid entering The Water  Refill the L S 258.001.00008
yellow phase container is almost Water
empty. container.
System Liquid level Only information. - L 258.003.00009
sensor connected

Rev. D

System Liquid level No connection  Reconnect LMS 258.002.00009
sensor disconnected between the liquid the Water
level sensor of the container.
Water container and
the instrument.  Check
connector of
the water
container.
 Call service.
System Liquid main Only information. - L 258.001.00009
container inserted
System Liquid main Only information. - LS 258.000.00009

container removed
System resumed from Only information. - L 256.000.00014

Stand By
The CRC of the integral Problems with the  Exchange LMS 265.000.00004
inserted into lane [lane integral check sum. integral.
number] has changed
since last use.  Call service.
The FlashCurve Display An internal error  Call service LMS 268.000.00001

Tool [tool name] was not has occurred.
found at [path]
The integral inserted into Problems with the  Exchange LMS 265.000.00003
lane [lane number] has an integral RF-Tag integral.
incorrect CRC in Cluster check sum.
[cluster index]. Expected  Call service.
[expected CRC], found
[found CRC].

Rev. D

The reagent integral Only information. - LMS 265.000.00001
removed from lane [lane
number of the removed
integral] was in use.
Transmitted flash curve An internal error  Call service. LMS 258.000.00032
corrupted. (invalid has occurred.
blocknumber: [block
number], JobID [JobID])
Unscheduled Job [SID] Only information. - L 262.000.00007
([replicate]) Cycle [cycle]
User [user name] logged Only information. - L 256.000.00001
in at level [login level].
User requested Priming. Only information. - L 256.000.00003
User sent low lewel Only information. - L 272.006.00001

command: [low level
command]
Wash Liquid entering Only information. - L 258.002.00010
green phase
Wash Liquid entering red The wash buffer  Refill the LS 258.000.00010
phase container is almost wash buffer
empty. container.
Wash Liquid entering The wash buffer  Refill the LS 258.001.00010
yellow phase container is almost wash buffer
empty. container.

Rev. D

Wash Liquid level sensor Only information. - L 258.003.00011
connected
Wash Liquid level sensor No connection  Reconnect LMS 258.002.00011

disconnected between the liquid the wash
level sensor of the buffer
wash buffer container.
container and the
instrument.  Check
connector of
the wash
buffer
container.
 Call service.
Wash Liquid main Only information. - L 258.001.00011
container inserted
Wash Liquid main Only information. - LS 258.000.00011

container removed
Washer initialization was Only information. - L 272.000.00004

requested by user
Event [event description] Only information - L 256.001.00004

from [sender module]
Import Mitigation Only information - L 256.005.00006

sequence [Mitigation
sequence name]
Import Assay Group Only information - L 256.006.00006
[Assay group name]

Rev. D

Failed to import Assay Problem with the  Call service. LMS 256.020.00006
(Article number [Art. assay
number], Abbreviation
[abbreviation], Lis Alias
[LisAlias]). Reason :An
Assay with same Article
Number but different
Abbreviation or LIS Alias
exists already.
Failed to import Assay Problem with the  Call service. LMS 256.021.00006
(Article number [Art. assay
number], Abbreviation
[LisAlias]). Reason :An
Assay with different Article
Number but same
Abbreviation exists
already.
Failed to import Assay LIS alias for the  Check LMS 256.022.00006
(Article number [Art. imported assay existing LIS
number], Abbreviation already used. aliases.
[LisAlias]). Reason :An  If possible,
Assay with different Article change
Number but same LIS existing LIS
Alias exists already. alias.
Start to import Assays Only information - L 256.030.00006

from file [absolute path to
the assay file]

Rev. D

Completed import of Only information - L 256.031.00006
Assays from file [absolute
path to the assay file]
Failed to import of Assays Problem with the  Call service LMS 256.032.00006
from file [absolute path to assays file
the assay file], no Assay
was changed
Failed to import from file Problem with the file  Call service LMS 256.033.00006
[absolute path to the
assay file]
Overwrite Dilution Only information - L 256.002.00007
Overwrite Generics Only information - L 256.003.00007
Overwrite Mitigation Only information - L 256.005.00007

Sequence [Mitigation
sequence name]
Overwrite AssayGroup Only information - L 256.006.00007
[Assay Group name]
User requested Pause Only information - L 256.000.00017
User requested Continue Only information - L 256.001.00017
Failed to load File [file Problem with the file  Call service LMS 256.000.00100
name]

Rev. D

Starter loaded (Lot Only information - L 258.000.00038
Number [LotNo], Vial
Number [Vial No.], Lane
[lane No], remaining
Shots: [remaining starter
shots])
Starter loaded in lane The starter bottle  Change the LMS 258.001.00038
[starter position] is expired loaded in that starter bottle
position is expired
Starter loaded in lane Problems with the  Exchange LMS 258.002.00038
[starter lane] has incorrect starter RF-Tag starter bottle
CRC (read: [read CRC], check sum.
calculated [calculated  Call service.
CRC]
Starter loaded in lane The starter type is  Loaded the LMS 258.003.00038
[starter lane] has wrong uncorrect correct starter
type. type.
Starter removed from lane Only information - L 258.004.00038
[starter lane]
Ancillary [Ancillary name], Only information - L 258.000.00039

Lot Number [LotNo], Vial
Number [Vial No.] loaded
at position [position] (Rem.
Vol: [Rem. Volume], LL
[liquid level])

Rev. D

OBS Expired Ancillary The OnBoard  Replace the LMS 258.001.00039
[Ancillary name], Lot Stability of the ancillary
Number [Lot.No.], Vial ancillary package is package.
Number [Vial No.] loaded expired.
[liquid level])
Expired Ancillary [Ancillary The Ancillary  Replace the LMS 258.002.00039
name], Lot Numebr loaded in that ancillary
[LotNo], Vial Number [Vial position is expired package
No] loaded at position
[position] (Rem. Vol:
[Rem. Volume], LL [liquid
level])
CRC invalid (read [read Problems with the  Exchange LMS 258.003.00039
CRC], calculated ancillary check sum. ancillary
[calculated CRC]) for
Ancillary [Ancillary name],  Call service.
Lot Number [LotNo], Vial
Number [Vial No.] loaded
[liquid level])
Perform daily initialization Only information - L 258.000.00040
System status changed Only information - L 258.000.00041

from [old status] to [new
status]
Backup [backup name] Only information - L 259.000.00005
started

Rev. D

AutoBackup started Only information - L 259.001.00005
Backup completed Only information - L 259.002.00005
Backup failed The backup is not  Re-start the LMS 259.003.00005

successfully back up
completed
 Call service
Aborted Job [SID] [assay An error during the  Call service LMS 262.000.00002
abbreviation] ([replicate]). incubation phase
Reason: Incubation time has occured
exceeded
No Starters found, or Missing starters.  Load the LMS 262.001.00005
starters are not primed needed
yet, to schedule Job [SID] starters.
([replicate]).
No Ancillary found to Missing ancillary.  Load the LMS 262.002.00005
schedule Job [SID] [assay needed
abbreviation] ([replicate]). ancillary.
No Mitigation Ancillary Missing mitigation  Load the LMS 262.003.00005
found to schedule Job ancillary needed
[SID] [assay abbreviation] mitigation
([replicate]). ancillary.

Rev. D

Short Integral Agitation The agitation time - LMS 262.001.00006
Time in lane [integral lane] for the integral
for Job [SID] [assay involved in that job
abbreviation]([replicate]) is not sufficient to
ensure the correct
magnetic particles
agitation
Failed to Aspirate The reagent volume  Restart the L 262.004.00016
[reagent] for Job [SID] present into the job with a
[assay integral is not new integral
abbreviation]([replicate]), enough to perform
Not enough Liquid (JobID the pipetting Cycle.
[JobID] Cycle [Pipetting
Cycle])
Failed to Aspirate A technical problem  Call service L 262.005.00016
[reagent] for Job [SID] occurs
[assay
abbreviation]([replicate]),
No LLD Signal
(JobID[JobID] Cycle
[Pipetting Cycle])
[assay
Bad LLD Signal
(JobID[JobID] Cycle
[Pipetting Cycle])

Rev. D

[assay
LLD Position Verification
Negative (JobID[JobID]
Cycle [Pipetting Cycle])
AM denied Mitigation An internal error  Call Service LMS 262.001.00032
Wash [Mitigation name] at has occurred
[Start Phase] from
Position [Ancillary
position], Reason: PipSeq
Unknown
[Start Phase] from
Position [Ancillary
position], Reason:
Mitigation Memory full
[Start Phase] from
Position [Ancillary
position], Reason: Too
late

Rev. D

[Start Phase] from
Position [Ancillary
position], Reason: Cycle
used
[Start Phase] from
Position [Ancillary
position], Reason: Data
garbled
[Start Phase] from
Position [Ancillary
position], Reason: Too
many reagents
[Start Phase] from
Position [Ancillary
position], Reason: Invalid
Reagent position

Rev. D

[Start Phase] from
Position [Ancillary
position], Reason: Number
reagents does not match
PipSeq
[Start Phase] from
Position [Ancillary
position], Reason: Wrong
Analyzer State
AM not able to start new An internal error  Call service LMS 262.000.00039
jobs has occurred
No response to query for No response is - L 263.000.00001

workorder for SID [SID] provided from the
within [seconds] seconds host for that SID on
time
Structure error in ASTM An error with the  Call service LMS 263.000.00002
1394 message LIS protocol is
occurred
Data format error in An error with the  Call service LMS 263.000.00003
message received from LIS communication
LIS is occurred

Rev. D

Sample Tube [SID] taken The sample tube is  Check the LMS 264.000.00045
offline (Lane[lane offline. Possible sample tube
number], Tube [Position in causes: and re-loaded
rack]) it if it is OK
 Not enough
sample liquid.
 Clot detected..
Duplicate Sample ID [SID] There are on board  Change one LS 264.000.00050
(Lane [lane first two samples with of the two
occurrence], Position the same ID occurrences.
[Row first occurence]/Lane
[Lane second occurence],
Position [Row second
occurance])
Illegal Sample ID found in An illegall SID is  Correct the LMS 264.000.00051
Rack read and it is not SID involved
saved in the error.
Empty positions detected Only information - LS 264.000.00052
in Lane [lane]
Rack identifier Barcode The rack identifier  Use another LS 264.000.00053

could not be detected in barcode can not be sample rack
Lane [lane] read by the barcode
reader
Rack identifier [rack The rack identifier  Use a sample L S 264.000.00054
identifier] not found in barcode can not be rack
Lane [lane] found in the system approved for
database the
instrument.

Rev. D

Misdetection of Rack The system  Use another LS 264.000.00055
Positions in lane [lane] recognizes a sample rack
mismatch between
the rack positions
read and the rack
positions that
should be read.
Rack inserted into wrong The rack was not  Re-loaded the L S 264.000.00056
lane [lane] inserted into the sample rack
lane where the in the correct
barcode reader was lane
focus on (according to
the LEDs
indication)
AM denied Assay [assay The assay was not  Call service LMS 265.002.00010
abbreviation] for loaded
Lane[lane] Reason:
Method Sequence storage
full
Lane[lane] Reason: Lane
storage full (too many
alternative methods)
Lane[lane] Reason: Too
many pipetting sequences
(com_gen limit exceeded)

Rev. D

many Method Sequence
steps
Lane[lane] Reason:
Method Sequence too
long
Lane[lane] Reason:
Method garbled
many virtual methods
Lane[lane] Reason:
Reference to unknown
Pipetting Sequence
Lane[lane] Reason: Lane
number invalid

Rev. D

Lane[lane] Reason:
Double Aspiration in R2-
Phase
Lane[lane] Reason:
Extended Phase
mismatch
Lane[lane] Reason:
Method already stored
Lane[lane] Reason:
Invalid Measurement
Parameter
Lane[lane] Reason:
Invalid Wash Parameter

Rev. D

Integral (OBS The loaded integral  See kit IFU LMS 265.001.00017
expired)found at lane has OBS expired
[lane number] with
ArticleNo [article number],
LotNo[LotNo], KitNo
[KitNo], rem.
rem. Calibr[rem.
values]
Integral (expired)found at The loaded integral  Use another LMS 265.002.00017
lane [lane number] with is expired integral
ArticleNo [article number],
LotNo[LotNo], KitNo
[KitNo], rem.
rem. Calibr[rem.
values]
Left Arm taken online Only information - L 265.000.00018
Left Arm taken offline The Sample Arm is  Initialize the L 265.001.00018
taken offline system
 If error
reoccurs, call
service
Right Arm taken online Only information - L 265.000.00019

Rev. D

Right Arm taken offline The Reagent Arm is  Initialize the L 265.001.00019
taken offline system
 If error
reoccurs, call
service
Integral without RF-Tag The system can not  Loaded LMS 265.000.00020
Information inserted into recognize the RF- another
lane [lane] Tag for that integral integral
 If error
reoccurs call
service
Integral Reagent Flap The integral flap  Close the LMS 265.000.00021
open, please close the has been open for Reagent Flap
Flap too long

Rev. D

Integral taken offline The integral is taken  Load a new LMS 265.000.00045
(ArtNo.:[Art.No.], Lane offline due to one of integral
[lane] Positions [position the following
in integral]) problems :  If error
reoccurs and
 The integral there is call
is expired service
 The article
number of
the integral
matches a
Real Assay,
but no
version of
integral
matchs the
assay
version.
 The CRC is
wrong.
 No liquid
was found
in any vials
Ancillary Rack loaded Only information - L 266.000.00002
Ancillary Rack unloaded Only information - L 266.001.00002

Rev. D

Ancillary [ancillary name] Only information - L 266.000.00003
from position [Ancillary
position ] removed
Needed Ancillary A needed ancillary  Reload the LMS 266.001.00003
[Ancillary name] from was removed ancillary
position [Ancillary before that its
position] removed aspirate phase was
finished
Ancillary taken offline The ancillary in that  Load a new LMS 266.000.00045
(Name: [Ancillary name], position is taken ancillary
Position [Ancillary offline due to one of
position] the following  If error
problems : reoccurs, call
service
 No liquid found
 The expiration
date is
exceeded.
 The ancillary
reagent has a
data recognition
issue
(Step : [Maintenance task
step]succeeded.
(Step: [Maintenance task
step] failed

Rev. D

Washer Aspiration Error An internal error  If error LMS 270.009.00001
occurred during occurred during the reoccurs, call
Background or Background check service
Lightcheck, Replicate
[Replicate number]
Aspiration Error occurred An internal error  If error LMS 270.009.00002
for Light Check, Replicate occurred during the reoccurs, call
[Replicate number] Background check service
DarkCount Error occurred An internal error  If error LMS 270.009.00003
during Maintenance, occurred during the reoccurs, call
Replicate [Replicate Background check service
number]
Spikes detected during A spike was  If error LMS 270.009.00004
Maintenance, Replicate detected during the reoccurs, call
[Replicate Number] Maintenance task service
Sample Scanner Only information - L 272.000.00006
initialization was
requested by user
Cover closed by user Only information - L 258.001.00027
[user name]
Aborted Job [SID] [Assay A problem with the  Call service LMS 262.019.00001
Abbreviation] ([replicate]). dispensation of the
Reason: Starter Dispense starter occurred
check
Only [tips available] There are not  Load LMS 270.005.00002
disposable tips available enough disposable disposable
([needed tips] needed) tips tips

Rev. D

Manual Input of RackID Only information - L 264.000.00057
[rack ID] in lane [lane]
Illegal Sample ID [SID] An illegal SID is  Re-load the LMS 264.000.00060

(Lane[lane], Position loaded SID in the
[sample position]) correct form
Event [event ID] from Only information - L 256.000.00004
[module], Parameters:
"[parameters]"
User [user name] logged Only information - L 256.001.00001
off.
Fatal error occured during An internal error  Call service LMS

database access. occurred during the
256.000.00018
Processing stopped. access to the
database
Software started Only information - L 256.000.00019
Software closed Only information - L 256.001.00019
Disposable Tips entering Disposable tips are  Load LS

258.000.00025
red phase entering in the red disposable
phase Tips
Disposable Tips entering Disposable tips are  Load LS
258.001.00025
yellow phase entering in the red disposable
phase Tips
Disposable Tips entering Only information - L 258.002.00025
green phase

Rev. D

Communication to An internal error  Restart the LMS
analyzer lost. occured system
 If the error
reoccurs
258.001.00029
please call
service
Analyzer stopped due to The cover was  Close the LMS
open cover during opened in the cover and
258.000.00044
operation. meantime that the initialize the
system was running system
Too many cuvettes Too many cuvettes  Remove LMS
258.000.00046
loaded. This may lead to a were added. some
cuvette jam. cuvettes
Enough cuvettes already There are enough  Don’t add LMS
loaded. Adding new cuvettes for the more cuvettes 258.000.00047
cuvettes may lead to a system
cuvette jam.
Failed to import Control There might be a  Retry to LMS
Definition '[Control mismatch for import the
definition name]', Lot Control Name control
Number '[Lot No]', LotNo and Barcode
Barcode '[barcode ID]'. and the import was  If error
reoccurs call 259.000.00004
not successfully
completed service
Aborted Job [SID] [assay The job was  Restart the LMS
abbreviation] ([replicate]) aborted due to an job
Reason: Reader internal error
DarkCount out of Range  If error
262.004.00002
reoccurs, call
service

Rev. D

abbreviation] ([replicate]): aborted due to an job
Reader DarkCount internal error
average is invalid  If error
262.005.00002
reoccurs, call
service
abbreviation] ([replicate]). aborted due to an job
Reason: Reader internal error
DarkCount exceeded  If error
262.006.00002
envelope reoccurs, call
service
Error while transmitting An error occurred  Retry the LMS
data to LIS during the transmission
transmission to the
LIS  If error
263.000.00004
reoccurs call
service
Error while receiving data An error occurred  Retry the LMS
from LIS during the reception download
from the LIS
 If error
263.000.00005
reoccurs call
host service
Liaison XL LIS module Only information - L 263.000.00006
running
Liaison XL LIS module Only information - L 263.000.00007

stopped
Liaison XL LIS module The LIS module  Call service LMS

263.000.00008
could not be started cannot start for an
internal error

Rev. D

Liaison XL LIS module The LIS module  Please wait LMS
could not be stopped cannot stop for an and retry
internal error
 If error
263.000.00009
reoccurs call
service
User requested release of Only information - L 266.002.00002
Ancillary Rack
Control '[Control Name]' The control is below  Re start the LMS

was below Manufacturer the Manufacturer control
Range for Assay '[Assay Range
Abbr]'.  If error
268.000.00002
reoccurs call
service
Control '[Control name]' The control is above  Re start the LMS
was above Manufacturer the Manufacturer control 268.000.00003
Range for Assay '[Assay Range
Abbr.]'.
Control '[Control name]' The control is below  If error LMS
268.000.00004
was below User Range for the User Range reoccurs call
Assay '[Assay Abbr.]'. service
Control '[Control name]' The control is above  Re start the LMS
268.000.00005
was above User Range for the User Range control
Assay '[Assay Abbr.]'.
Dose [Dose result] Only information - L
calculated for '[SID]'
268.000.00006
[Assay Abbr.]',
CalibrationID: ‘[Cal. ID]'

Rev. D

Integral [Art.No] lot No. Only information - L
269.000.00002
[Lot.No] kit No. [Kit No]
refilled manually
User resetted the Liquid Only information - L
272.000.00007
Levels on the integral in
lane 2
Calibration for Assay The calibration of  It is LMS 256.003.00015
[Assay Abbr.] expired that assay is necessary to
expired. perform a
new
In case of combi
calibration for
father assay it is
that assay.
reported the
abbreviation of the
calibrated son.
More than 1000 Assays There are too many  Call service LMS 256.000.00027
are loaded, this is not assays stored in the
supported database.
More than 100 Dilution There are too many  Call service LMS 256.001.00027
Sequences are loaded, dilutions sequences
this is not supported stored in the
database.
More than 267 Mitigation There are too many  Call service LMS 256.002.00027
Sequences are loaded, mitigation
this is not supported sequences stored in
the database.

Rev. D

Reagent Integral No news jobs can  Wait until that L M S 258.002.00002
temperature out of range start because the the the
for too long, suspend new temperature of the temperature
jobs reagent area is out of the reagent
of range from more area back in
than 30 minutes. range and
then re-start
the jobs
 If re-occurs
call the
service
System Setting 'Software Only information - L 259.001.00007
Language' changed from
'[Old language] to '[New
language]'
System Setting 'IFU Only information - L 259.002.00007
Language' changed from
'[Old language]' to '[New
language]'
System Setting 'Date Only information - L 259.003.00007
Format' changed from
'[Old date format]' to '[New
date format]'
System Setting 'Time Only information - L 259.004.00007
Format' changed from
'[Old time format]' to '[New
time format]’

Rev. D

System Setting 'Decimal Only information - L 259.005.00007
Point' changed from '[Old
decimal point]' to '[New
decimal point]'
System Setting 'Country Only information - L 259.006.00007
Code' changed from '[Old
country code]' to '[New
country code]'
System Setting 'Auto Only information - L 259.007.00007
Backup Path' changed
from '[Old path]' to '[New
path]'
System Setting 'Backup Only information - L 259.008.00007
Path' changed from '[Old
path]' to '[New path]'
System Setting 'Automatic Only information - L 259.009.00007
Archiving' enabled
System Setting 'Automatic Only information - L 259.010.00007

Archiving' disabled
System Setting 'Eventlog Only information - L 259.011.00007

Size' changed from '[Old
size]' to '[New size]'
System Setting 'Auto log- Only information - L 259.012.00007
off' disabled

off' after '[Minutes]'
minutes enabled

Rev. D

off' changed from '[Old
setting]' to '[New setting]'
System Setting 'Auto Only information - L 259.015.00007
Backup (Days) Frequency'
changed from '[Old value]'
to '[New value]'
System Setting 'Auto- Only information - L 259.016.00007
Backup (Days) Delete
Results older than’
to '[New value]'
System Setting 'Disable Only information - L 259.017.00007
Failed Results Beeper'
enabled
Failed Results Beeper'
disabled
System Error Beeper'
enabled
System Error Beeper'
disabled
Fatal Error Beeper'
enabled

Rev. D

Fatal Error Beeper'
disabled
Sample Loading Beeper'
enabled
Sample Loading Beeper'
disabled
System Setting 'Auto Mute Only information - L 259.025.00007
Interval' changed from
'[old value]' to '[new value]'
System Setting 'Random Only information - L 259.026.00007
Access' enabled
System Setting 'Random Only information - L 259.027.00007

Access' disabled
LIS Setting 'Instrument ID' Only information - L 259.000.00008

changed from '[Old
instrument ID]' to '[New
instrument ID]'.
LIS Setting 'Host ID' Only information - L 259.001.00008
changed from '[Old host
ID]' to '[New host ID]'
LIS Setting 'COM Port' Only information - L 259.002.00008
changed from '[Old COM
Port]' to '[New COM Port]'

Rev. D

LIS Setting 'Baudrate' Only information - L 259.003.00008
to '[New value]'
LIS Setting 'Data Bits' Only information - L 259.004.00008
to '[New value]'
LIS Setting 'Stop Bits' Only information - L 259.005.00008
to '[New value]'
LIS Setting 'Parity' Only information - L 259.006.00008
to '[New value]'
LIS Setting 'Date Only information - L 259.007.00008
Template' changed from
'[Old date template]' to
'[New date template]'
LIS Setting 'Time Only information - L 259.008.00008
Template' changed from
'[Old time template]' to
'[New time template]'
LIS Setting 'Enable Only information - L 259.009.00008
Manufacturer record'
enabled
LIS Setting 'Enable Only information - L 259.010.00008
Manufacturer record'
disabled

Rev. D

LIS Setting 'Timeout Only information - L 259.011.00008
(Query)' changed from
'[Old value]' to '[New
value]'
LIS Setting 'Send Frame Only information - L 259.012.00008
Timer (No Response)'
to '[New value]'
LIS Setting 'Bad Frame Only information - L 259.013.00008
Send <NAK> Timer
(Interframe)' changed from
value]'
LIS Setting 'Delimiter Only information - L 259.014.00008
Field' changed from '[Old
value]' to '[New value]'
Component' changed from
value]'
Repeat' changed from
value]'
Escape' changed from
value]'

Rev. D

LIS Setting 'LIS module' Only information - L 259.018.00008
enabled
LIS Setting 'LIS module' Only information - L 259.019.00008

disabled
LIS Setting 'Send Only information - L 259.020.00008

Automatically Queries
Host for Worklist' enabled
Automatically Queries
Host for Worklist' disabled
Compressed Query'
enabled
Compressed Query'
disabled
Compressed Comments'
enabled
Compressed Comments'
disabled
Automatically Sends All
Results' enabled
Automatically Sends All
Results' disabled

Rev. D

LIS Setting 'Respond to Only information - L 259.028.00008
LIS Query for Results'
enabled
LIS Setting 'Respond to Only information - L 259.029.00008
LIS Query for Results'
disabled
LIS Setting 'Record ASTM Only information - L 259.030.00008
1381' enabled

1381' disabled

1394' enabled

1394' disabled
LIS Setting 'Busy Timer' Only information - L 259.034.00008

to '[New value]'
LIS Setting 'Result Flag Only information - L 259.035.00008
Style' changed from '[Old
style]' to '[New style]'
LAS Setting 'LAS module' Only information - L 259.001.00009
enabled
LAS Setting 'LAS module' Only information - L 259.002.00009

disabled

Rev. D

LAS Setting 'COM Port' Only information - L 259.003.00009
changed from '[Old COM
Port]' to '[New COM Port]'
LAS Setting 'Baudrate' Only information - L 259.004.00009
to '[New value]'
Aborted Job '[SID]' '[Assay The job was  Insert a new LMS 262.020.00001
Abbr.]' ([replicate]). aborted due to an starter bottle
Reason: Starter Reagent empty starter bottle and restart
depleted the job
Analyser is stopped The Analyser is  Check the LMS 262.001.00008
because no signal from stopped because no connection of
system liquid level sensor signal was received system liquid
from the system level sensor
liquid level sensor
 If the error re-
occurs call
the service
Analyser is stopped The Analyser is  Check the LMS 262.002.00008
because no signal from stopped because no connection of
wash liquid level sensor signal was received wash liquid
from ther wash level sensor
liquid level sensor
 If the error re-
occurs call
the service
Liaison XL LAS module Only information - L 263.030.00010
running
Liaison XL LAS module Only information - L 263.031.00010

stopped

Rev. D

Calibration for Integral in The calibration for  It is LMS 265.000.00023
lane ‘[Lane]’ is expired integral that was necessary to
’[Abbr.]’ inserted in that lane perform a
is expired new
calibration for
that integral
Analyzer could not start The Priming could  Wait until the L M S 258.000.00048
Priming due to wrong not be started system status
analyzer status because the becomes a
analyzer status is valid one
different from either
Maintenance, or
Standby, or Ready
Analyzer could not start The Fill Ring could  Wait until the L M S 258.001.00048
Clear Cuvettes due to not be started system status
wrong analyzer status because the becomes a
Maintenance, or
Standby, or Ready
Analyzer could not start The Backgound  Wait until the L M S 258.002.00048
Background due to wrong could not be started system status
Maintenance, or
Standby, or Ready

Rev. D

Analyzer could not start The Light Check  Wait until the L M S 258.003.00048
Light Check due to wrong could not be started system status
Maintenance, or
Standby, or Ready
COP denied “LAS Sample The analyzer could  None (the LMS 262.001.00043
in Position”: unknown job, not process the workcell will
job ID [job ID] sample. re-route the
sample)
COP denied “LAS Sample The analyzer could  None (the LMS 262.002.00043
in Position”: job already not process the workcell will
cancelled, job ID [job ID] sample. re-route the
sample)
Calibrator with SID [SID] The calibrator could  Restart the LMS 262.000.00045
for assay [Assay abbr.] not be scheduled calibration
failed with “Mechanical
Error” as it could not be  If the error
scheduled reoccurs, call
service

Rev. D

Liaison XL LAS Module The LAS  Check the LMS 263.000.00010
could not be started communication Liaison XL
could not be configuration
initialized for LIS and
LAS
 Check the
integrity of the
table
 If the error
reoccurs, call
service
Liaison XL LAS Module An internal system  Call service LMS 263.001.00010
could not be stopped error has occurred
LAS workcell did not The communication  Check the LMS 263.000.00011
respond with ACK or NAK with the LAS device workcell
in time was not status
successfully
completed.  Check the
LAS
connection
 If error
reoccurs, call
service

Rev. D
Analyzer
Messages Message Description Action Effect Event ID
Unknown command An internal system  Call service LMS 000.000.00002
error has occurred

error has occurred
Parameter value out of An internal system  Call service LMS 000.000.00003

range error has occurred
Read failure of permanent An internal system  Call service LMS 000.000.00005

parameter error has occurred
Error during self test Error during self test  Call service LMS 000.001.00012
Worklist command An internal system  Call service LMS 000.006.00016

execution timeout (Dev: error has occurred
[Device address], SA:
[subassembly ID])
Illegal parameter type An internal system  Call service LMS 000.000.00017
definition error has occurred
Invalid parameter index An internal system  Call service LMS 000.000.00018

error has occurred
Access to parameter not An internal system  Call service LMS 000.000.00019

allowed error has occurred
Wrong parameter unlock An internal system  Call service LMS 000.000.00020

code error has occurred

Rev. D

Illegal parameter type in An internal system  Call service LMS 000.000.00021
command error has occurred
Illegal parameter length in An internal system  Call service LMS 000.000.00022

The device [device The device cannot  Call service LMS 000.006.00032
address] be addressed
(SA:[subassembly id])
cannot be addressed
Internal CAN-bus error Internal CAN-bus  Call service LMS 000.006.00033
while command error while
transmission to a device command
transmission to a
device
Device [device The device failed  Call service LMS 000.006.00034
type,device variant,device registering to CAN-
individual] failed bus.
registering to CAN-bus,
event [event ID]

Rev. D

Connection definition An internal system  Call service LMS 000.006.00035
[[device type endpoint error has occurred
A],[port endpoint
A],[device individuum
number endpoint
A]]:[device variant
endpoint A] <-> [[device
type endpoint B],[port
endpoint B],[device
individuum number
endpoint B]]:[device
variant endpoint B] has
failed, event [CAN error
code]
Routing defintion for An internal system  Call service LMS 000.006.00036
device [device error has occurred
address]:[CAN port] has
code]
Set headless An internal system  Call service LMS 000.006.00037
communication for device error has occurred
at port [CAN port] has
code]
Set exclusive read mode An internal system  Call service LMS 000.006.00038
at port [CAN port] has error has
failed, event [CAN error occurred
code]

Rev. D

Communication to the Communication to  Call service LMS 000.006.00039
device [device address] the device is failed
(SA [subassembly]) failed,
event [event ID]
Link definition [[CAN bus An internal system  Call service LMS 000.006.00040
number A],[port A]] <-> error has occurred
[[CAN bus number
B],[port B]] has failed,
event [CAN error code]
CAN communication An internal system  Call service LMS 000.006.00041
system failed, event [CAN error has occurred
event id]
No communication from An internal system  Call service LMS 000.002.00050
PC for too long time error has
occurred
Command cannot be An internal system  Call service LMS 000.003.00066
scheduled to worklist error has occurred
(block [worklist block id],
sequence [Worklist
sequence id]), reason
[status]
Pipetting command An internal system  Call service LMS 000.003.00067
(id:[pipetting sequence error has occurred
id]) cannot be scheduled
to worklist (block [Worklist
block id], sequence
[Worklist sequence id]),
reason [status]

Rev. D

Notify handler storage An internal system  Call service LMS 000.013.00078
overflow (block [Worklist error has occurred
block id], sequence
[Worklist sequence id])
External non-maskable An internal system  Call service LMS 000.020.00080
interrupt error has occurred
Watchdog timer underflow An internal system  Call service LMS 000.020.00081

error has occurred
Main clock oscillation Main clock  Call service LMS 000.020.00082

stopped oscillation stopped
Voltage out-of-range The voltage is out-  Call service LMS 000.020.00083

of-range
Undefined instruction An internal system  Call service LMS 000.020.00084

occurred error has occurred
Arithmetic overflow An internal system  Call service LMS 000.020.00085

occurred error has occurred
System cycle belated by The system cycle is  If error LMS 000.012.00129

[1/10 seconds] [1/10s] belated as reported reoccurs call
service
Coordinate target missing An internal system  Call service LMS 000.016.00130
for index [target index] error has occurred
Pipettor response timeout. A pipettor response  Call service LMS 000.014.00145

Arm: [left(0)/right(1) arm], is timeout
State: [pipettor driver
state]

Rev. D

Pipettor response timeout. A pipettor response  Call service LMS 000.015.00145
Arm: [left(0)/right(1) arm], is timeout
State: [pipettor driver
state]
Pipettor write sync An internal system  Call service LMS 000.014.00146
timeout. Arm: [left (0)/right error has occurred
(1) arm]
Pipettor write sync An internal system  Call service LMS 000.015.00146
timeout. Arm: [left (0)/right error has occurred
(1) arm]
Tip eject failed. Arm: [left The tip eject is  If error LMS 000.014.00147
(0)/right (1) arm] failed. reoccurs call
service
OLV sensor calibration OLV sensor  If error LMS 000.015.00150
failed calibration failed. reoccurs call
service
OLV transportation airgap OLV transportation  If error LMS 000.015.00151
calibration failed airgap calibration reoccurs call
failed service
Reagent temperature out- The reagent  Call service LMS 000.017.00160
of-range for too long time temperature has
been out-of-range
for too long.
Ring temperature out-of- The incubator  Call service LMS 000.017.00161
range for too long time temperature has
been out-of-range
for too long

Rev. D

Too many subsequent There are too many  Call service LMS 000.017.00162
washer aspiration failures subsequent washer
aspiration failures.
cavities while starter subsequent cavities
reagent temperature out- while the starter
of-range reagent temperature
is out-of-range
RLU measurement subsequent RLU
failures measurement
failures.
Too many cuvettes Too many cuvettes - LMS 000.018.00176
removed while solid waste are removed while
drawer is opened the solid waste
drawer is opened
Internal error occurred An internal system  Call service LMS 000.012.00255
error has occurred

Supply voltage out of The supply voltage  If error LMS 002.000.00006

range ([mVolt] mV) is out of range reoccurs, call
service
Supply voltage back in The supply voltage  - L 002.000.00007
range ([mVolt] mV) is back in range

Rev. D

Circuit [circuit name] The reported voltage  If error LMS 002.000.00032
voltage out of range is out of range reoccurs call
([mVolt] mV) service
Circuit [circuit name] The reported voltage - L 002.000.00033
voltage back in range is back in range
([mVolt] mV)
error has occurred

Unable to execute An internal system  Call service LMS 004.000.00014


error has occurred

error has occurred

error has occurred

error has occurred

error has occurred

Rev. D

error has occurred

error has occurred

error has occurred

error has occurred

error has occurred







Rev. D




Command execution An internal system  Call service LMS 005.001.00016

timeout error has occurred
Not enough cuvettes There are not  Load L 005.006.00032

available enough cuvettes cuvettes
available
Not enough cuvettes There are not  Load L 005.007.00032
available enough cuvettes cuvettes
available
Replenishment of ring The refill of the  Load LMS 005.003.00033
suspended due to missing incubator is cuvettes
cuvettes suspended due to
missing cuvettes
Insufficient starter reagent An insufficient  Load a new LMS 005.007.00034
detected while priming starter reagent starter bottle
quantity is detected
while priming

Rev. D

Integrity error(s) occured A (some) integrity  If error LMS 005.000.00035
during system test error(s) occured reoccurs call
during the system service
test
Cuvette Supply is not The Cuvette Supply  If error LMS 017.000.00001
initialized is not initialized reoccurs call
service
service
service
service
Tube Heater is not The Tube Heater is  If error LMS 017.004.00001
initialized not initialized reoccurs call
service
service
service
service

Rev. D

Cuvette Supply received An internal system  Call service LMS 017.000.00002
an unknown command error has
occurred
occurred
occurred
an unknown command error has occurred
Tube Heater received an An internal system  Call service LMS 017.004.00002

unknown command error has occurred



Cuvette Supply / Tube An internal system  Call service LMS 017.000.00003

Heater received a error has occurred
parameter value out of
range
Heater had a read failure error has occurred
of permanent parameter

Rev. D

Cuvette Supply / Tube The Cuvette Supply  If error LMS 017.000.00006
Heater supply voltage out / Tube Heater reoccurs call
of range ([Volt] V) supply voltage is out service
of range
Cuvette Supply / Tube The Cuvette Supply - L 017.000.00007
Heater supply voltage / Tube Heater
back in range ([Volt] V) supply voltage is
back in range
Cuvette Supply found an The Cuvette Supply  Call service LMS 017.000.00012
error during self test found an error
during self test
during self test
during self test
during self test
Tube Heater found an The Tube Heater  Call service LMS 017.004.00012
during self test
during self test
during self test

Rev. D

during self test
Cuvette Supply received a An internal system  Call service LMS 017.000.00013
command parameter error has occurred
value out of range
value out of range
value out of range
value out of range
Tube Heater received a An internal system  Call service LMS 017.004.00013
value out of range
value out of range
value out of range
value out of range

Rev. D

Heater is unable to error has occurred
execute command
Cuvette Supply is unable An internal system  Call service LMS 017.001.00014
to execute command error has occurred


Tube Heater is unable to An internal system  Call service LMS 017.004.00014

execute command error has occurred




command which is not
implemented
implemented

Rev. D

implemented
implemented
implemented
implemented
implemented
implemented
Heater reached a timeout error has occurred
during command
execution

Rev. D

during command
execution
during command
execution
during command
execution
during command
execution
during command
execution
during command
execution
during command
execution

Rev. D

Heater received an illegal error has occurred
parameter type definition
Heater received an invalid error has occurred
parameter index
Heater received an error has occurred
unauthorized access to
parameter
Heater received a wrong error has occurred
parameter unlock code
command with illegal
parameter type
command with illegal
parameter length
Tube Heater measured The Tube Heater  Call service LMS 017.004.00034
temperature fails measured
plausibility check temperature fails the
plausibility check
plausibility check

Rev. D

plausibility check
plausibility check
Tube Heater given An internal system  Call service LMS 017.004.00035
ambient temperature fails error has occurred
plausibility check
plausibility check
plausibility check
plausibility check
Cuvette Supply can not An internal system  Call service LMS 017.000.00037
calibrate sensor error has occurred
Not initialized Not initialized  If error LMS 018.000.00001

reoccurs call
service
reoccurs call
service

Rev. D

reoccurs call
service
reoccurs call
service
reoccurs call
service
reoccurs call
service
reoccurs call
service
reoccurs call
service
reoccurs call
service
reoccurs call
service
unknown command An internal system  Call service LMS 018.000.00002
error has occurred

Rev. D

error has occurred

error has occurred

error has occurred

error has occurred

error has occurred

error has occurred

error has occurred

error has occurred

error has occurred



Rev. D

Supply voltage out of The Supply voltage  If error LMS 018.000.00006
range ([Volt] V) is out of range reoccurs call
service
Supply voltage back in The Supply voltage  - L 018.000.00007
range ([Volt] V) is back in range
Thermal or short circuit Thermal or short  Call service LMS 018.003.00008

protection of driver circuit protection of
driver
Position reached several The Position is  If error LM 018.002.00009
retries reached after reoccurs call
several retries service
Position reached several Position reached  If error LM 018.003.00009
retries several retries reoccurs call
service
service
service
Target not reached Target not reached  Call service LMS 018.002.00010

Rev. D

Command terminated A command is  Call service LMS 018.000.00011

terminated
Command terminated Command  Call service LMS 018.001.00011

terminated

terminated

terminated

terminated

terminated

terminated

terminated

terminated

terminated

Rev. D

Error during self test An error is occurred  Call service LMS 018.001.00012
during the self test
Command parameter An internal system  Call service LMS 018.000.00013

value out of range error has occurred








Rev. D












Rev. D

Command not An internal system  Call service LMS 018.000.00015

implemented error has occurred










Rev. D












Rev. D

error has occurred




Measured temperature The incubator  Call service LMS 018.001.00034

fails plausibility check measured
temperature fails the
plausibility check
plausibility check
plausibility check
Ambient temperature fails An internal system  Call service LMS 018.001.00035
plausibility check error has occurred

Rev. D


Transport blocked by An internal system  Call service LMS 018.003.00036

cuvette pushers error has occurred
Cuvette sensor can not be An internal system  Call service LMS 018.000.00037
calibrated error has occurred
Cuvette position in The cuvette position  Call service LMS 018.005.00038

transport already full in the incubator is
already full
Movement failure cuvette A movement failure  Call service LMS 018.005.00040
loader occurs for the
cuvette loader
Init position of Incubator The Initial position of  If error LM 018.003.00043
changed since last the Incubator has reoccurs call
calibration changed since last service
calibration
reoccurs call
service
error has occurred


Rev. D


range ([mVolt] mV) is out of range reoccurs call
service
Supply voltage back in The supply voltage - L 019.000.00007

driver
service
Command terminated A command is  Call service LMS 019.000.00011

terminated
Error during self test An error occurs  Call service LMS 019.000.00012



Rev. D




error has occurred




Aspiration detection Washer aspiration  If error LM 019.000.00032

failure (failed [Failed], detection failure reoccurs call
monitored [Monitored]) service
Aspiration sensor Washer aspiration  Call service LMS 019.000.00033
calibration error sensor calibration
error

Rev. D

Aspiration sensor Washer aspiration  If error LMS 019.000.00034
calibration error sensor calibration reoccurs call
error service
reoccurs call
service
reoccurs call
service
reoccurs call
service
reoccurs call
service
LCMP Pump is not LCMP Pump is not  If error LMS 020.004.00001
initialized initialized reoccurs call
service
service
error has occurred

error has occurred

error has occurred

Rev. D

error has occurred
LCMP Pump received an An internal system  Call service LMS 020.004.00002



LCMP Pump received a An internal system  Call service LMS 020.004.00003

parameter value out of error has occurred
range
range
LCMP Pump had a read An internal system  Call service LMS 020.004.00005
failure of permanent error has occurred
parameter
parameter
Supply voltage CHN 1 out The supply voltage  If error LMS 020.000.00006
of range ([Volt] V) CHN 1 is out of reoccurs call
range service

Rev. D

LCMP Pump supply The LCMP pump  If error LMS 020.004.00006
voltage out of range supply voltage is out reoccurs call
([mVolt] mV) of range service
LCMP Pump supply The LCMP pump  If error LMS 020.005.00006
Supply voltage CHN 1 The supply voltage - L 020.000.00007
back in range ([Volt] V) CHN 1 is back in
range ([Volt] V)
LCMP Pump supply The LCMP pump - L 020.004.00007
voltage back in range supply voltage is
([mVolt] mV) back in range
([mVolt] mV)
LCMP Pump supply The LCMP pump - L 020.005.00007
([mVolt] mV)
driver
driver
driver
driver

Rev. D

LCMP Pump has a LCMP pump has a  Call service LMS 020.004.00008
thermal or short circuit thermal or short
driver
LCMP Pump has a LCMP Pump has a  Call service LMS 020.005.00008
driver
service
service
service
service
LCMP Pump had to retry LCMP pump had to  If error LM 020.004.00009
positioning several times retry positioning reoccurs call
several times service
LCMP Pump had to retry LCMP pump had to  If error LM 020.005.00009

Rev. D

LCMP Pump did not LCMP Pump did not  Call service LMS 020.004.00010
reache target reache target
reache target reache target
LCMP Pump terminated LCMP Pump  Call service LMS 020.004.00011

command terminated
command
command terminated
command
LCMP Pump found an LCMP Pump found  Call service LMS 020.004.00012
error during self test an error during self
test
test

Rev. D





value out of range
value out of range




Rev. D

LCMP Pump is unable to An internal system  Call service LMS 020.004.00014






command which is not error has occurred
implemented
implemented


Rev. D


LCMP Pump reached a An internal system  Call service LMS 020.004.00016

timeout during command error has occurred
execution
execution




illegal parameter type error has occurred
definition
definition

Rev. D

error has occurred

invalid parameter index error has occurred



unauthorized access to error has occurred
parameter
parameter

wrong parameter unlock error has occurred
code
code

Rev. D

command with illegal error has occurred
parameter type
parameter type

parameter length
parameter length
High Voltage out of High Voltage out of  Call service LMS 020.000.00032
Range Range
LCMP Pump failed in LCMP Pump failed  Call service LMS 020.004.00032
automatic calibration in automatic
calibration
LCMP Pump failed in LCMP Pump failed  Call service LMS 020.005.00032
automatic calibration in automatic
calibration
Count Rate Overrun Count Rate Overrun  Call service LMS 020.000.00033
Counter Read Error Counter Read Error  Call service LMS 020.000.00034

Rev. D

Internal Error: Fifo Full An internal system  Call service LMS 020.000.00064
error has occurred
error has occurred
error has occurred
error has occurred
Hardware Error: AD5620 Hardware Error:  Call service LMS 020.000.00080

Failure AD5620 Failure
Hardware Error: Trigger Hardware Error:  Call service LMS 020.000.00096

Lightbarrier Trigger Lightbarier



Internal Error: No Injection Internal Error: No  If error LMS 020.000.00112

performed Injection performed reoccurs call
service

Rev. D

No Cuvette detected No Cuvette detected  If error LMS 020.000.00144
reoccurs call
service
reoccurs call
service
reoccurs call
service
reoccurs call
service
error has occurred

error has occurred

error has occurred


range service

Rev. D

range
Thermal or short circuit An internal system  Call service LMS 022.000.00008
protection of driver error has occurred
Target not reached An internal system  Call service LMS 022.000.00010

error has occurred








Rev. D

error has occurred




No scanner No scanner  If error LM 022.001.00039

communication communication reoccurs call
service
No scanner answer No scanner answer  If error LM 022.001.00041
reoccurs call
service
Scanner temperature too The scanner  If error LM 022.001.00042
high temperature is too reoccurs call
high service
Scanner takes too long to The scanner takes  If error LM 022.001.00043
reach the correct polygon too long to reach the reoccurs call
speed correct polygon service
speed
focus too long to focus reoccurs call
service

Rev. D

switch on laser diode too long to switch on reoccurs call
laser diode service
switch off laser diode too long to switch off reoccurs call
laser diode service
Scanner polygon speed The scanner  If error LM 022.001.00047
not ok polygon speed is not reoccurs call
ok service
Scanner not focused The scanner is not  If error LM 022.001.00048
focused reoccurs call
service
reset too long to reset reoccurs call
service
reset too long to reset reoccurs call
service
Sample barcode scanner Timeout waiting for  If error LMS 022.001.00051
was switched off a rack reoccurs call
service
1st position barcode 1st position barcode  If error L 022.001.00065
missing (/A) missing (/A) reoccurs call
service
No rack ID barcode found No rack ID barcode  If error L 022.001.00066
was found reoccurs call
service

Rev. D

Position barcode missing Position barcode  If error L 022.001.00067
missing reoccurs call
service
Wrong empty tube Wrong empty tube  If error L 022.001.00068
barcode barcode reoccurs call
service
Sample barcode too long The sample barcode  If error L 022.001.00069
is too long reoccurs call
service
Barcode ‘&’ character Barcode ‘&’  If error LM 022.001.00070
doubling failed character doubling reoccurs call
failed service
Rack position barcodes The rack position  If error L 022.001.00071
not continuously present barcodes are not reoccurs call
or more sample barcodes continuously present service
read than position or there are more
barcodes sample barcodes
than position
barcodes
Environmental The environmental  If error LS 022.000.00080
temperature is out of temperature is out of reoccurs call
range range service
Environmental The environmental - L 022.000.00081
temperature is back in temperature is back
range in range
ERROR_ERR_INTERNA An internal system  Call service LMS 022.001.00208
L_DEFAULT_BARSCAN_ error has occurred
ZYKL

Rev. D

L_DEFAULT_GETSCAN error has occurred
NERSTATUSBACKGRO
UND
L_DEFAULT_READPAR error has occurred
AMETERBACKGROUND
L_WRITEPARAMETERB error has occurred
ACKGROUND_ANZ
L_DEFAULT_WRITEPAR error has occurred
AMETERBACKGROUND
L_DEFAULT_GETBARC error has occurred
ODEBACKGROUND
L_DEFAULT_STARTPOL error has occurred
YGONBACKGROUND
L_DEFAULT_STOPPOLY error has occurred
GONBACKGROUND
L_DEFAULT_SETFOCUS error has occurred
BACKGROUND
L_DEFAULT_LASERONB error has occurred
ACKGROUND

Rev. D

L_DEFAULT_LASEROFF error has occurred
BACKGROUND
L_DEFAULT_SCANNER error has occurred
RESETBACKGROUND
L_DEFAULT_RESTOREF error has occurred
ACTORYBACKGROUND
L_DEFAULT_READ_SCA error has occurred
NNER_STATE
L_DEFAULT_WAIT_POW error has occurred
ER_ON
L error has occurred
Stirrer not initialized The stirrer is not  If error LMS 023.001.00001

initialized reoccurs call
service
error has occurred

error has occurred

error has occurred

Rev. D




range service
range
Stirrer active. Unable to An internal system  Call service LMS 023.001.00014

Stirrer command An internal system  Call service LMS 023.001.00016

execution timeout error has occurred


Rev. D

error has occurred




range service
range
range service
range
Left reagent temperature The temperature of  If error LMS 023.000.00037
out of range ([°C] °C) the left reagent bay reoccurs call
area is out of range service

Rev. D

Middle reagent The temperature of  If error LMS 023.000.00038
temperature out of range the middle reagent reoccurs call
([°C] °C) bay area is out of service
range
Right reagent temperature The temperature of  If error LMS 023.000.00039
out of range ([°C] °C) the right reagent bay reoccurs call
area is out of range service
Left Seebeck voltage too The left Seebeck  If error LM 023.000.00041
low ([Volt] V) voltage is too low reoccurs call
service
Left Seebeck voltage too The left Seebeck  If error LM 023.000.00042
high ([Volt] V) voltage is too high reoccurs call
service
Middle Seebeck voltage The middle Seebeck  If error LM 023.000.00043
too low ([Volt] V) voltage is too low reoccurs call
service
Middle Seebeck voltage The middle Seebeck  If error LM 023.000.00044
too high ([Volt] V) voltage is too low reoccurs call
service
Right Seebeck voltage too The right Seebeck  If error LM 023.000.00045
low ([Volt] V) voltage is too low reoccurs call
service
Right Seebeck voltage too The right Seebeck  If error LM 023.000.00046
high ([Volt] V) voltage is too high reoccurs call
service
Seebeck voltage The Seebeck  If error LM 023.000.00047
difference too high ([Volt] voltage difference is reoccurs call
V) too high service

Rev. D

Stirrer rotation not ok The stirrer rotation is  If error LMS 023.001.00048
not ok reoccurs call
service
I2C bus to left integral I2C bus to left  If error LMS 023.000.00049
sensor area defect integral sensor area reoccurs call
defect service
I2C bus to right integral I2C bus to right  If error LMS 023.000.00050
sensor area defect integral sensor area reoccurs call
defect service
Internal error Internal error  Call service LMS 023.001.00255

reoccurs call
service
error has occurred



service

Rev. D



error has occurred




Cleaning Solution Control The Cleaning  If error LMS 034.005.00001

is not initialized Solution device is reoccurs call
not initialized service
error has occurred

error has occurred

error has occurred

Rev. D

error has occurred

error has occurred

error has occurred
Parameter value is out of An internal system  Call service LMS 034.000.00003

Liquid Waste Control: An internal system  Call service LMS 034.003.00003

Actor is not defined error has occurred
Cleaning Solution Control: An internal system  Call service LMS 034.005.00003

Actor is not defined error has occurred


range ([mVolt] mV) is out of range reoccurs call
([mVolt] mV) service
([mVolt] mV)
Cabinet unable to execute An internal system  Call service LMS 034.000.00014
command error has occurred,

Rev. D

System Liquid Control An internal system  Call service LMS 034.001.00014
unable to execute error has occurred,
command
Wash Buffer Control An internal system  Call service LMS 034.002.00014
command
Liquid Waste Control An internal system  Call service LMS 034.003.00014
command
Solid Waste Control An internal system  Call service LMS 034.004.00014
command
Cleaning Solution Control An internal system  Call service LMS 034.005.00014
command
implemented error has occurred,





Rev. D


timeout error has occurred,






definition error has occurred,

error has occurred,

allowed error has occurred,

code error has occurred,

Rev. D


Liquid waste full The liquid waste  Empty liquid LMS 034.003.00032
containers are full waste
containers
System liquid empty The water container  Refill the LMS 034.001.00033
is empty water
container
Wash buffer empty The wash buffer  Refill the LMS 034.002.00034
container is empty wash buffer
container
System liquid entering The water container  Refill the L 034.001.00048
yellow phase is entering in yellow water
phase container
System liquid entering red The water container  Refill the LS 034.001.00049
phase is entering in red water
phase container
Wash buffer entering The wash buffer  Refill the L 034.002.00050
yellow phase container is entering wash buffer
in yellow phase container
Wash buffer entering red The wash buffer  Refill the LS 034.002.00051
phase container is entering wash buffer
in red phase container

Rev. D

Liquid waste entering The liquid waste  Empty the L 034.003.00052
yellow phase container is entering liquid waste
in yellow phase container
Liquid waste entering red The liquid waste  Empty the LS 034.003.00053
phase container is entering liquid waste
in red phase container
System liquid main The water main  Re-insert the L 034.001.00054
container removed container is system liquid
removed main
container
Wash buffer main The wash buffer  Re-insert the L 034.002.00055
container removed main container is wash buffer
removed main
container
Liquid waste container The liquid waste  Re-insert the L 034.003.00056
removed container is liquid waste
removed container
Solid waste drawer pulled The solid waste  Re-insert the L 034.004.00057
out drawer is pulled out solid waste
container
System liquid level sensor The water container  Re- L 034.001.00058
disconnected level sensor is connected
disconnected the system
liquid level
sensor

Rev. D

Wash buffer level sensor The wash buffer  Re- L 034.002.00059
disconnected container level connected
sensor is the wash
disconnected buffer level
sensor
service

range
parameter
LCMP Pump supply LCMP Pump supply  If error LMS 048.000.00006
voltage out of range voltage is out of reoccurs call
([mVolt] mV) range service
LCMP Pump supply LCMP Pump supply - L 048.000.00007
voltage back in range voltage is back in
([mVolt] mV) range
driver

Rev. D

LCMP Pump had to retry LCMP Pump had to  If error LM 048.000.00009
reach target reach target
LCMP Pump terminated An internal system  call service LMS 048.000.00011

test
value out of range

implemented
execution
definition

Rev. D

parameter
code
parameter type
parameter length
LCMP Pump failed in LCMP Pump failed  If error LMS 048.000.00032
automatic calibration in automatic reoccurs call
calibration service
service

range
parameter

Rev. D

LCMP Pump supply LCMP Pump supply  If error LMS 052.000.00006
voltage out of range voltage is out of reoccurs call
([mVolt] mV) range service
LCMP Pump supply LCMP Pump supply - L 052.000.00007
voltage back in range voltage is back in
([mVolt] mV) range
driver
LCMP Pump had to retry LCMP Pump had to  If error LM 052.000.00009
reach target reach target

command terminated
command
test
value out of range

Rev. D

implemented
execution
definition

parameter
code
parameter type
parameter length
LCMP Pump failed in LCMP Pump failed  If error LMS 052.000.00032
automatic calibration in automatic reoccurs call
calibration service

Rev. D

Peristaltic Pump is not Peristaltic Pump is  If error LMS 053.000.00001
service
Peristaltic Pump received An internal system  If error LMS 053.000.00002
an unknown command error has occurred reoccurs call
service
Peristaltic Pump received An internal system  If error LMS 053.000.00003
a parameter value out of error has occurred reoccurs call
range service
Peristaltic Pump had a An internal system  If error LMS 053.000.00005
read failure of permanent error has occurred reoccurs call
parameter service
Peristaltic Pump supply Peristaltic Pump  If error LMS 053.000.00006
Peristaltic Pump supply Peristaltic Pump - L 053.000.00007
Peristaltic Pump has a Peristaltic Pump has  Call service LMS 053.000.00008
thermal or short circuit a thermal or short
driver
Peristaltic Pump had to Peristaltic Pump had  If error LM 053.000.00009
retry positioning several to retry positioning reoccurs call
times several times service
Peristaltic Pump did not Peristaltic Pump did  Call service LMS 053.000.00010
reach target not reach target

Rev. D

Peristaltic Pump Peristaltic Pump  Call service LMS 053.000.00011
terminated command terminated
command
Peristaltic Pump found an Peristaltic Pump  Call service LMS 053.000.00012
during self test
Peristaltic Pump received An internal system  Call service LMS 053.000.00013
a command parameter error has occurred
value out of range
Peristaltic Pump is unable An internal system  Call service LMS 053.000.00014

a command which is not error has occurred
implemented
Peristaltic Pump reached An internal system  Call service LMS 053.000.00016
a timeout during error has occurred
command execution
an illegal parameter type error has occurred
definition
an invalid parameter error has occurred
index
an unauthorized access to error has occurred
parameter

Rev. D

a wrong parameter unlock error has occurred
code
a command with illegal error has occurred
parameter type
parameter length
Peristaltic Pump failed in Peristaltic Pump  Call service LMS 053.000.00032
calibration of init sensor failed in calibration
of init sensor
Peristaltic Pump is not Peristaltic Pump is  If error LMS 054.000.00001
service
an unknown command error has occurred

a parameter value out of error has occurred
range
Peristaltic Pump had a An internal system  Call service LMS 054.000.00005
read failure of permanent error has occurred
parameter
Peristaltic Pump supply Peristaltic Pump  If error LMS 054.000.00006

Rev. D

Peristaltic Pump supply Peristaltic Pump - L 054.000.00007
Peristaltic Pump has a Peristaltic Pump has  Call service LMS 054.000.00008
thermal or short circuit a thermal or short
driver
Peristaltic Pump had to Peristaltic Pump had  If error LM 054.000.00009
retry positioning several to retry positioning reoccurs call
times several times service
Peristaltic Pump did not Peristaltic Pump did  Call service LMS 054.000.00010
reach target not reach target
Peristaltic Pump Peristaltic Pump  Call service LMS 054.000.00011

terminated command terminated
command
Peristaltic Pump found an Peristaltic Pump  Call service LMS 054.000.00012
during self test
a command parameter error has occurred
value out of range
Peristaltic Pump is unable An internal system  Call service LMS 054.000.00014

a command which is not error has occurred
implemented

Rev. D

Peristaltic Pump reached An internal system  Call service LMS 054.000.00016
a timeout during error has occurred
command execution
an illegal parameter type error has occurred
definition
an invalid parameter error has occurred
index
an unauthorized access to error has occurred
parameter
a wrong parameter unlock error has occurred
code
parameter type
parameter length
Peristaltic Pump failed in Peristaltic Pump  Call service LMS 054.000.00032
calibration of init sensor failed in calibration
of init sensor
error has occurred

error has occurred

Rev. D

error has occurred





service
Reader unable to execute An internal system  Call service LMS 064.001.00014

Antenna unable to An internal system  Call service LMS 064.002.00014

General command An internal system  Call service LMS 064.000.00016

Reader command An internal system  Call service LMS 064.001.00016


Rev. D

Antenna command An internal system  Call service LMS 064.002.00016


error has occurred




RFID decoder interface. RFID decoder  If error LMS 064.000.00064

Unable to communicate interface can’t reoccurs call
with reader IC communicate with service
reader IC
Unable to communicate interface. Unable to reoccurs call
reader IC

Rev. D

Antenna interface. Unable Antenna interface.  If error LMS 064.000.00065
to communicate with Unable to reoccurs call
antenna communicate with service
antenna
antenna
RFID write/compare RFID write/compare  If error LMS 064.001.00066
check failure ([block check failure for that reoccurs call
number] block number) block number service
Wrong RFID tag receive Wrong RFID tag  If error LM 064.001.00067
length received length reoccurs call
service
Multiple RFID tags in field There are more than  If error LM 064.001.00068
one RFID tags in reoccurs call
field service
Tag timeout. No answer Tag timeout. No  If error LM 064.001.00069
received from RFID tag answer received reoccurs call
from RFID tag service
RFID reader IC error: No RFID reader IC  If error L 064.001.00070
RFID tag found error: No RFID tag reoccurs call
found service
RFID reader IC error: RFID reader IC  If error LM 064.001.00071
Checksum error error: Checksum reoccurs call
error service
RFID reader IC error: Bit RFID reader IC  If error LM 064.001.00072
collision error error: Bit collision reoccurs call
error service

Rev. D

framing error error: Bit framing reoccurs call
error service
error has occurred

error has occurred

error has occurred

error has occurred






Rev. D

service


Aspirate unable to An internal system  Call service LMS 069.003.00014




Aspirate command An internal system  Call service LMS 069.003.00016




Rev. D

error has occurred






reader IC
reader IC
antenna

Rev. D

antenna
length receive length reoccurs call
service
one RFID tag in field reoccurs call
service
RFID reader IC error: No RFID reader IC  If error LM 069.001.00070
found service
error service
error service
error service

Rev. D

Bubble for a longer time Bubble for a longer  If error LMS 069.003.00096
time reoccurs call
service
Air detected in starter There is air in the  If error LMS 069.003.00097
fluidics starter fluidics reoccurs call
service
Starter bubble sensor The sensor needs to  If error L 069.003.00099
needs to be calibrated be calibrated reoccurs call
service
error has occurred

error has occurred

error has occurred

error has occurred




Rev. D



service


Aspirate unable to An internal system  Call service LMS 070.003.00014




Aspirate command An internal system  Call service LMS 070.003.00016


Rev. D



error has occurred






reader IC
reader IC

Rev. D

antenna
antenna
length receive length reoccurs call
service
one RFID tag in field reoccurs call
service
RFID reader IC error: No RFID reader IC  If error LM 070.001.00070
found service
error service
error service

Rev. D

error service
Bubble for a longer time Bubble for a longer  If error LMS 070.003.00096
time reoccurs call
service
Air detected in starter There is air in the  If error LMS 070.003.00097
fluidics starter fluidics reoccurs call
service
Starter bubble sensor The sensor needs to  If error L 070.003.00099
needs to be calibrated be calibrated reoccurs call
service
Watchdog reset [internal Watchdog reset  Call service LMS 252.000.00001
error code]




error has occurred


Rev. D



Watchdog reset Watchdog reset  Call service LMS 253.000.00001
Insufficient parameters for An internal system  Call service LMS 253.000.00002

command [command ID], error has occurred
received [number of
received bytes] bytes
Command parameter out An internal system  Call service LMS 253.000.00003
of range. Command: error has occurred
[command ID]
Communication buffer An internal system  Call service LMS 253.000.00004
overflow error has occurred
No coordinates for An internal system  Call service LMS 253.000.00005

position [target index] error has occurred
Write failure of permanent An internal system  Call service LMS 253.000.00007



Rev. D


error has occurred




Left arm, collision An internal system  Call service LMS 253.000.00022

avoided. Moving to error has occurred
coordinate: [target index
right arm to move to], right
arm at coordinate: [left
arm actual target index]
Right arm, collision An internal system  Call service LMS 253.000.00023
avoided. Moving to error has occurred
coordinate: [target index
left arm to move to], left
arm at coordinate: [right
arm actual target index]

Rev. D

No connection to wash There is no  Call service LMS 253.000.00031
pump connection with the
wash pump
Left arm, pump error Left arm pump error  Call service LMS 253.000.00040
(noStr) [pump error]
Right arm, pump error Right arm pump  Call service LMS 253.000.00041
(noStr) [pump error] error
Left arm, pump response Left arm pump  Call service LMS 253.000.00042
timeout response timeout
Right arm, pump Right arm pump  Call service LMS 253.000.00043
response timeout response timeout
Left arm, pump error Left arm pump error  Call service LMS 253.000.00044
[pump error]
Right arm, pump error Right arm pump  Call service LMS 253.000.00045
[pump error] error
OLV controller response OLV controller  Call service LMS 253.000.00046

timeout, command response timeout,
[command ID sent to command
OLV]
Disposable tip dropped The disposable tip is  If error LMS 253.000.00048
dropped reoccurs call
service
Left arm, X-axis, home Left arm, X-axis,  Call service LMS 253.000.00100
sensor always ON when home sensor always
initialising ON when initialising

Rev. D

Left arm, Y-axis, home Left arm, Y-axis,  Call service LMS 253.000.00101
Left arm, Z-axis, home Left arm, Z-axis,  Call service LMS 253.000.00102
Right arm, X-axis, home Right arm, X-axis,  Call service LMS 253.000.00103
Right arm, Y-axis, home Right arm, Y-axis,  Call service LMS 253.000.00104
Right arm, Z-axis, home Right arm, Z-axis,  Call service LMS 253.000.00105
Left arm, X-axis, timeout Left arm, X-axis,  Call service LMS 253.000.00110
when moving to home timeout when
sensor moving to home
sensor
Left arm, Y-axis, timeout Left arm, Y-axis,  Call service LMS 253.000.00111
sensor
Left arm, Z-axis, timeout Left arm, Z-axis,  Call service LMS 253.000.00112
sensor

Rev. D

Right arm, X-axis, timeout Right arm, X-axis,  Call service LMS 253.000.00113
sensor
Right arm, Y-axis, timeout Right arm, Y-axis,  Call service LMS 253.000.00114
sensor
Right arm, Z-axis, timeout Right arm, Z-axis,  Call service LMS 253.000.00115
sensor
Left arm, X-axis, motor Left arm, X-axis,  If error LMS 253.000.00120
overload detected motor overload reoccurs call
detected service
Left arm, Y-axis, motor Left arm, Y-axis,  If error LMS 253.000.00121
detected service
Left arm, Z-axis, motor Left arm, Z-axis,  If error LMS 253.000.00122
detected service
Right arm, X-axis, motor Right arm, X-axis,  If error LMS 253.000.00123
detected service
Right arm, Y-axis, motor Right arm, Y-axis,  If error LMS 253.000.00124
detected service

Rev. D

Right arm, Z-axis, motor Right arm, Z-axis,  If error LMS 253.000.00125
detected service
Left arm, X-axis, no Left arm, X-axis, no  Call service LMS 253.000.00130
encoder steps detected encoder steps
detected
Left arm, Y-axis, no Left arm, Y-axis, no  Call service LMS 253.000.00131
detected
Left arm, Z-axis, no Left arm, Z-axis, no  Call service LMS 253.000.00132
detected
Right arm, X-axis, no Right arm, X-axis,  Call service LMS 253.000.00133
encoder steps detected no encoder steps
detected
Right arm, Y-axis, no Right arm, Y-axis,  Call service LMS 253.000.00134
detected
Right arm, Z-axis, no Right arm, Z-axis,  Call service LMS 253.000.00135
detected
Left arm, X-axis, position Left arm, X-axis,  If error LMS 253.000.00140
is out of tolerance. position is out of reoccurs call
Coordinate: [target index] tolerance. service
Left arm, Y-axis, position Left arm, Y-axis,  If error LMS 253.000.00141

Rev. D

Left arm, Z-axis, position Left arm, Z-axis,  If error LMS 253.000.00142
Right arm, X-axis, position Right arm, X-axis,  If error LMS 253.000.00143
Right arm, Y-axis, position Right arm, Y-axis,  If error LMS 253.000.00144
Right arm, Z-axis, position Right arm, Z-axis,  If error LMS 253.000.00145
Left arm, X-axis, motor Left arm, X-axis,  Call service LMS 253.000.00150
controller response motor controller
timeout. Register: [SCTL response timeout.
register], State:
[transmission state]
Left arm, Z-axis, motor Left arm, Z-axis,  Call service LMS 253.000.00152
register], State:
Right arm, X-axis, motor Right arm, X-axis,  Call service LMS 253.000.00153
register], State:

Rev. D

Right arm, Z-axis, motor Right arm, Z-axis,  Call service LMS 253.000.00155
register], State:
Motor controller watchdog Motor controller  Call service LMS 253.000.00160
reset. watchdog is reset.
Left arm, pump warning A pump warning  If error LM 253.000.00194

[warning reported by occurs for the left reoccurs call
pump] arm service
Right arm, pump warning A Right arm pump  If error LM 253.000.00195
[warning reported by warning occurs. reoccurs call
pump] service
Left arm, pump warning Left arm, pump  If error LM 253.000.00196
(noStr) [warning reported warning reoccurs call
by pump] service
Right arm, pump warning Right arm, pump  If error LM 253.000.00197
(noStr) [warning reported warning reoccurs call
by pump] service
Right arm, OLV analyze. Right arm, OLV  Call service LMS 253.000.00199
Pump steps mismatch. analyze. Pump
Expected [expected pump steps mismatch.
steps], Detected [detected
pump steps]
Left arm, X-axis, motor Left arm, X-axis,  If error LM 253.000.00200
overload detected, move motor overload reoccurs call
retried successfully detected, move service
retried successfully

Rev. D

Left arm, Y-axis, motor Left arm, Y-axis,  If error LM 253.000.00201
Left arm, Z-axis, motor Left arm, Z-axis,  If error LM 253.000.00202
Right arm, X-axis, motor Right arm, X-axis,  If error LM 253.000.00203
Right arm, Y-axis, motor Right arm, Y-axis,  If error LM 253.000.00204
Right arm, Z-axis, motor Right arm, Z-axis,  If error LM 253.000.00205
Too many subsequent diti Too many  Re start the LMS 000.014.00152
pickup failures subsequent routine
disposable tips
pickup failures  If error
occurred during the reoccurs, call
routine service

Rev. D

Maintenance process The maintenance  Re start the L 000.012.00192
aborted due to general was aborted due to maintenance
error a general error process
 If error
reoccurs call
service
Maintenance process The maintenance  Re start the L 000.012.00193
aborted due to timeout was aborted due to maintenance
condition an internal error process
 If error
reoccurs call
service
Maintenance process The maintenance  Load L 000.012.00194
aborted due to missing was aborted due to cuvettes and
cuvettes missing cuvettes re start the
maintenance
process
 If error
reoccurs call
service
Maintenance process The maintenance  After having L 000.012.00195
aborted due to offline was aborted due to initialized the
pipettor an internal error system, re
start the
maintenance
process
 If error
reoccurs call
service

Rev. D

Maintenance process Only information - L 000.012.00196
completed with integrity
errors
Maintenance process The maintenance  Change the L 000.012.00197
aborted due to was aborted due to starter and
unavailable starter unavailable starter re-start the
maintenance
 If error
reoccurs
calls ervice
Air present at the start of Only information  If error LM 069.003.00100
the aspiration reoccurs call
service
Air is present at the start Only information  If error LM 070.003.00100
of the aspiration reoccurs call
service
Internal Error: Data An internal system  Call service LMS 020.003.000
Compression failed error has occurred 65
High side drive IC failure An internal system  Call service LMS 069.000.000
or contact failure of the error has occurred 81
valve [valve number]
High side drive IC failure An internal system  Call service LMS 070.000.00081
or contact failure of the error has occurred
valve [valve number]

Rev. D
Insufficient number of An internal system  Call service LMS 252.000.00002

command parameters. error has occurred
Expected [number of
expected command
parameter bytes],
received [number of
received command
parameter bytes] bytes
OLV controller error [error An internal system  Call service LMS 253.000.00038
number] error has occurred
OLV controller warning An internal system  Call service LMS 253.000.00039

[warning number] error has occurred
Right arm, LLD/OLV An internal system  Call service LMS 253.000.00051

trigger line defect error has occurred
detected
L_DEFAULT_SCANNER error has occurred
RESETBACKGROUND
Data lost during An internal error has  Call service LMS 048.000.00033
communication occurred
Data lost during An internal error has  Call service LMS 052.000.00033
communication occurred
Too many subsequent An internal error has  Call service LMS 005.004.00036
darkcounts out-of-range occurred

reoccurs, call
service

Rev. D

error has occurred

Write failure of permanent An internal system  Call service LMS 055.000.00004



range ([Volt] V) is out of range reoccurs, call
service
range is back in range
Error during self test An error occurred  Call service LMS 055.000.00012

Enable to execute An internal system  Call service LMS 055.000.00014

command, because of error has occurred
unsupported device
address or subassembly


Rev. D

error has occurred




CAN Status Message An internal system - LMS 055.000.00031

error has recovered.
Pressure in range Information only - L 055.000.00036
Pressure out of range The pressure is out  Call service LMS 055.000.00037
of range
Pressure out of range for The pressure has  Call service LMS 055.000.00038
too long been out of range
for too long time
Liquid in vacuum line An internal system  Call service LMS 055.000.00039
detected error has occurred

Rev. D

Rev. D
10 Technical Data
10 Technical Data
10.1 Power Requirements
System
Voltage: 100 V - 240 V +/- 10 %
Frequency: 50 - 60 Hz
Power consumption: mean 400 W (550 W peak)
mean: 1365 BTU (peak: 1877 BTU)
Input current range 6 A – 2.5 A
Fuses: 250VAC T6.3AH (High breaking capacity) 5x20 mm
PC
Voltage 100 V - 240 V
Frequency: 50 - 60 Hz
Power consumption: mean: 300 W (mean: 1024 BTU)
Rated input current 8 A/ 4 A

Rev. D
10 Technical Data
10.2 Laser of the Bar-code Scanner
System
Class: Class 2 laser product
Communication RS 232 C
Available bar-codes  Codabar (set as default)
 Code 39 (set as default)
 Code 128/ EAN 128 (set as default)
 2/ 5 Interleaved (to be set)
Please check with local service support the enabling status of the bar-code types of
interest.
Barcode types not strictly compliant with this list are not allowed and must not be used on
the system.
Barcodes quality shall match Category A or B (according to ANSI X3.182 standard) or
category 4 and 3 (according to ISO/IEC 15416 standard). In addition:
 0.167 mm ≤ module width ≤ 0.5 mm
 1:2.5 ≤ bar width ratio ≤ 1:3 (if 0.167 mm ≤ module width < 0.2 mm) or
 1:2 ≤ bar width ratio ≤ 1:3 (if 0.2 mm ≤ module width ≤ 0.5 mm)
Maximal output 1.3 mW
radiation:
Pulse duration: 70 s, 35 s
Emitted wave length: 630 - 670 nm
Standards: EN 60825-1: 2001
Complies with 21 CFR 1040.10 and 1040.11 except for deviations pursuant to Laser Notice
No. 50, dated July 26th, 2001 at the date of manufacture.

Rev. D
10 Technical Data
Reading distance: 30 – 310 mm
Handheld barcode reader

Class: Class 1 LED product
Communication USB
Maximal output 0.76 mW
radiation:
Pulse duration: 10 s to 8000 s
Emitted wave length: LED 645 nm
Standards: ITE Equipment: IEC 60950-1, EN 60950-1
LED: IEC 60825-1:1993+A1+A2
EN 60825-1:1994+A1+A2
Emissions: FCC Part 15, ICES-003, CISPR 22, EN 55022
Immunity: CISPR 24, EN 55024
10.3 Computer and Connections
Hardware:
The following specifications are the minimum requirements.
Processor: Intel Dual Core E6550, 2.33 GHz or better
Memory (RAM): At least 2 GB
Hard disk: 2 physical hard disks (at least 200 GB each)
DVD-ROM burner: 16x, compatible with PC system

Rev. D
10 Technical Data
Ports: 2 serial RS 232 ports

1 parallel port
1 LAN port
At least 6 USB (4 on the rear panel and 2 in the front panel)
Modem: Internal, 56K
Monitor: 17 inch, touch screen
1280x1024 pixel (VGA connections supported)
Network 10/ 100 Mb Ethernet
Printer USB printer compatible with the installed operating system.
Both network and local printers are supported.
The printer that shall be used by Main User Interface shall be defined as “default printer”.
Software:
Operating system: Refer to the release note of the SW version to install/ installed

Rev. D
10 Technical Data
10.4 Dimensions
System complete
Width: LIAISON®XL: 150 cm (59 in)
LIAISON®XL LAS: 172 cm (68 in)
Depth: 90 cm (35.5 in), monitor excluded
Height: With closed top covers: 150 cm – 165 cm (59 in – 65 in) (height adjustment feet), monitor
excluded
With open top covers: 233 cm – 248 cm (92 in – 98 in) (height adjustment feet)

Rev. D
10 Technical Data
10.5 System Clearance
5cm
TOP
VIEW
50cm*
60cm
with and without
printer support
85cm 85cm
Figure 10-1: System Clearance
* Left lateral clearance is not applicable to LIAISON®XL LAS.

Rev. D
10 Technical Data
10.6 Weight
System complete
LIAISON®XL: 315 kg (695 lb)
®
LIAISON XL LAS: 325 kg (717 lb)
10.7 Environmental Conditions
Environmental This standard applies to equipment designed to be safe at least under following conditions:
Condition:
Indoor use.
Temperature: Operating: 15 to 32 °C
Storage: 5 to 45 °C
Transport: -20 °C to 70 °C
Humidity: Operating: 10 - 85 % non-condensing
Storage: 10 - 90 % non-condensing
Transport: 10 - 90 % non-condensing
Pollution degree: 2 (EN 61010-1:2001)
Installation Class: 2 (EN 61010-1:2001)
Sunlight: No direct sunlight.
May mislead optical sensors and affect performance.

Rev. D
10 Technical Data
Altitude: Operating up to 3000 m above mean sea level.

Storage: as required for air travel.
Dust: No excessive dust
10.8 Noise
At Operator Normal 63.9 dBA

Position
At Bystanders Positions 61.4 dBA
10.9 Temperature Range
Ambient 15°C – 32°C (59°F – 89.6°F)

Incubator 36.5 °C – 38.5 °C (97.7 °F – 101.3 °F)
Inside the system Ambient temperature ± 5°C (± 9°F)
Reagent loading bay 11°C – 15°C (51.8°F - 59°F)
Sample loading bay Ambient temperature ± 3°C (± 5.4°F)
Starter tubes 35.5°C – 37.5 °C (95.9 °F – 99.5 °F )

Rev. D
10 Technical Data
10.10 Water quality
The water to be used for the dilution and reconstitution of the Liaison XL reagents and consumables should comply with the definition of
“Instrument Feed Water”, according to CLSI standard “Preparation and Testing of Reagent Water in the Clinical Laboratory; Approved
Guideline – Fourth Edition”.
In particular, the water shall contain the following characteristics:
 pH: 5.0 – 8.0
 conductivity: <2 µSi/cm
 resistivity: > 0.5 M Ohm-cm
 TOC: < 500 ppb
 SiO2: <1.0 ppm
 Bacteria: <10 CFU/m

Rev. D
11 Appendix A: Cuvette Instruction for Use

11.1 Intended Use
Cuvettes (REF X0016) are required for the performance of the LIAISON®XL assays on the LIAISON®XL Analyzer.
Use only DiaSorin approved cuvettes.
11.2 Materials Provided
 1 shipping box containing 4 user boxes.

 Each user box contains 9 cuvette packs of 200 cuvettes per pack.
 1800 cuvettes per user box, totalling 7200 single cavity reaction cuvettes per shipping box.
 For additional details such as proper test performance of LIAISON®XL assays consult instructions for use of the assay to be performed.
11.3 Handling
For the description of the proper handling procedure, refer to chapter 5.5.1.

Rev. D
11.4 Storage
 Unopened at 0-30 °C in the original box.

 Do not expose to sunlight or humidity.
 After use, reseal the user box to protect the modules from contamination.
 Do not use after the expiration date given on the label.
11.5 Warnings and Precautions for Users
 Observe the normal precautions required for handling all laboratory reagents.
 Disposal of all waste material should be in accordance with local guidelines.
 If material packaging has been damaged upon delivery, please notify DiaSorin representative immediately. In this case, the usage of
cuvettes shall be avoided before any approval from DiaSorin.
 Any cuvettes that have not been directly loaded from the cuvette bag (intentionally or non-intentionally) are not to be utilized on the
system but should be discarded immediately.

Rev. D
11.6 Meaning of Symbols
CE Mark
IVD In Vitro Diagnostic
REF Catalogue Number
CONT Number of items contained in a bag or a box
LOT Lot Number
One time usage only
Protect from direct light
Product storage temperature
Expiration date of the product
Contact information of the manufacturer
Right side HIBC Barcode (according to primary data structure of

ANSI/HIBC 2.3 – 2009 standard).
For LIAISON®XL cuvettes: +E125X00165S
Left side HIBC Barcode (according to secondary data structure
of ANSI/HIBC 2.3 – 2009 standard)

Rev. D
12 Appendix B: Tip Instruction for Use

12.1 Intended Use
Disposable Tips (REF X0015) are required for the performance of the LIAISON®XL assays on the LIAISON®XL Analyzer.
Use only DiaSorin approved disposable tips.
12.2 Materials Provided
 1 shipping box containing 12 user boxes.

 Each user box contains 6 disposable tip trays with 96 disposable tips per tray.
 576 tips per user box, totalling 6912 single disposable tips per shipping box.
 For additional details such as proper test performance of LIAISON®XL assays consult instructions for use of the assay to be performed.
12.3 Handling
For the description of the proper handling procedure, refer to chapter 5.5.2.

Rev. D
12.4 Storage
 Unopened at 0-30 °C in the original box.

 Do not expose to sunlight or humidity.
 After use, reseal the user box to protect the modules from contamination.
 Do not use after the expiration date given on the label.
12.5 Warnings and Precautions for Users
 Observe the normal precautions required for handling all laboratory reagents.
 Disposal of all waste material should be in accordance with local guidelines.
 If material packaging has been damaged upon delivery, please notify DiaSorin representative immediately. In this case, the usage of
disposable tips shall be avoided before any approval from DiaSorin.
 Any disposable tips whose cleanness and integrity cannot be ensured (e.g. fallen to the ground) are not to be utilized on the system but
should be discarded immediately.

Rev. D
12.6 Meaning of Symbols
CE Mark
IVD In Vitro Diagnostic
REF Catalogue Number
CONT Number of items contained in a bag or a box
LOT Lot Number
One time usage only
Protect from direct light
Product storage temperature
Expiration date of the product
Contact information of the manufacturer
Right side HIBC Barcode (according to primary data structure of

ANSI/HIBC 2.3 – 2009 standard).
For LIAISON®XL tips: +E125X00155S
Left side HIBC Barcode (according to secondary data structure
of ANSI/HIBC 2.3 – 2009 standard)

Rev. D

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LIAISON® XL

DiaSorin S.p.A. 2012. All rights reserved

Table of Contents ............................................................................................I

1 Introduction ..................................................................................... 1-1

LIAISON XL - Instructions for use TOC - I

1.10 Instrument Labelling and Safety Labels......................................................... 1-34

2 PC security measures..................................................................... 2-1

3 Measuring Principle of the LIAISON®XL Immunoassays ............ 3-1

TOC - II LIAISON XL - Instructions for use

3.3 Measuring Function Description ...................................................................... 3-5

4 System Description......................................................................... 4-1

5 Use of the System ........................................................................... 5-1

LIAISON XL - Instructions for use TOC - III

5.9 Results .............................................................................................................. 5-87

6 Software Functions ......................................................................... 6-1

TOC - IV LIAISON XL - Instructions for use

7 Quality Control (QC) ....................................................................... 7-1

8 Maintenance .................................................................................... 8-1

LIAISON XL - Instructions for use TOC - V

9 Troubleshooting and Error Messages .......................................... 9-1

10 Technical Data ............................................................................... 10-1

11 Appendix A: Cuvette Instruction for Use .................................... 11-1

TOC - VI LIAISON XL - Instructions for use

11.3 Handling ............................................................................................................ 11-1

12 Appendix B: Tip Instruction for Use ............................................ 12-1

LIAISON XL - Instructions for use TOC - VII

1.1.1 Intended Use

LIAISON XL - Instructions for use Page 1-1

1.2 Customer Support

1.3 Proprietary statement

Page 1-2 LIAISON XL - Instructions for use

LIAISON XL - Instructions for use Page 1-3

1.6 DiaSorin Warranty

Page 1-4 LIAISON XL - Instructions for use

1.7 Messages, Notes and Symbols

1.7.1 Display of Warnings and Notes

LIAISON XL - Instructions for use Page 1-5

1.7.2 Utilized Warning Symbols

Caution, hot surface!

Cut injury hazard!

No objects shall be put on the opening flaps.

Page 1-6 LIAISON XL - Instructions for use

Disconnect mains power connector before servicing!

Power Supply characteristics

Maximum supported load for extensible board.

Maximum load for printer support.

Wash Solution Tank

Cleaning Solution Tank

Liquid Waste Tank

Indication of the location of Main Switch / Emergency Stop button.

LIAISON XL - Instructions for use Page 1-7

Page 1-8 LIAISON XL - Instructions for use

1.7.3 Other Symbols

Canadian Standard Association international compliance

LIAISON XL - Instructions for use Page 1-9

Consult instructions for use

Disposal of Electrical and Electronic Equipment

Page 1-10 LIAISON XL - Instructions for use

1.8 Hazard Instructions