TECHNICAL NOTE

Subject: Release of software version 4.2.1.1

Project: Liaison® XL, Liaison® XL LAS & Liaison® XL PMA
ID Number: 172
Revision: A
Date: 08/03/2018
Author: D.Belluto
Ref ECR / TB / DC / ECO / QH /
N.A.
FA / WS / Other:
 Service manual
 User manual
 User Service Book manual
 Quick Guide
Impact on:  Maintenance Book
 SW
 Other:
- LXL TN 006
- LXL TN 033
Attachments: Attachments:
 XL-SDI-N48-M (171220) (Rev.A) LIAISON XL Introduction to SW
V4.2.1 (all users).pdf
 XL-SDI-N47-M (171220) (Rev.A) LIAISON XL Introduction to SW
V4.2.1 (internal users).pdf
 XL-SDI-N11-T (171218) (Rev.C) Liaison XL SW V4.2.1 Installation
Procedure.pdf
 Declaration Liaison XL - Software V4.2.1.1 validated & contents
(OS compatibility).pdf
 XL-SDI-N33-T (171212) (Rev.A) LIAISON XL SW V4.2.1.1
Installation Check-List.pdf
 LXL_SW_Setup_4.2.1.1.zip
 LXL_Patch_for_DSbat_4.2.1.1.zip

Impact on the analyzer installed base : Affected Spare Parts / Kits: Estimated implementation labor time:
ALL Liaison® XL, Liaison® XL LAS, N.A. 2,5 hours.
Liaison® XL PMA.
ALL Countries except for CHINA. Note:
N.A.
Timeline:
Within 9 months from the release of Rev.
A of this TN (December 2018).

1. DISTRIBUTION ............................................................................................................................... 3
2. PURPOSE ......................................................................................................................................... 3
3. ADMINISTRATIVE NOTES ............................................................................................................... 3
3.1. SGAT ( FOR SUBS ONLY ) ..................................................................................................................... 3
3.1.1. Worksheet (WS) management ................................................................................................... 3
3.1.2. Additional information ............................................................................................................... 3
3.2. FOR DISTRIBUTORS .............................................................................................................................. 3
4. SPARE PARTS .................................................................................................................................. 4
5. PROCEDURE .................................................................................................................................... 4
5.1. INSTALLATION PROCEDURE...................................................................................................................... 4

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 5.1.1. Important remarks for the installation ........................................................................................ 4
5.1.2. Installation Check-List ............................................................................................................... 4
5.2. DOWNLOADS ....................................................................................................................................... 4
5.3. USER SOFTWARE CHANGES ...................................................................................................................... 5
5.4. USER DOCUMENTATION .......................................................................................................................... 5
5.5. UNSOLVED ANOMALIES ........................................................................................................................... 5
5.5.1. Important remarks .................................................................................................................... 5
5.6. CUSTOMER TRAINING ............................................................................................................................ 5
6. REQUALIFICATION ......................................................................................................................... 5
7. PPE .................................................................................................................................................. 6

Revision History
Revision Date Changed by Detail

A 08/03/2018 D.Belluto Initial version. Release of SW V 4.2.1.1. ALL

countries except CHINA.

DiaSorin Confidential

Potential Biohazard & Electrical Hazard.

Observe local and national provisions, legislation and laboratory regulations at all Times.

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 Subject: Release of software version 4.2.1.1
ID Number: 172 Revision: A Date: 08/03/2018 Author: D.BELLUTO

1. Distribution
All DiaSorin Subsidiaries (except CHINA) and Distributors.

2. Purpose
The aim of this Technical Note is to release the Liaison® XL SW version 4.2.1.1.

3. Administrative notes
The installation of Liaison® XL SW version 4.2.1.1 applies to Liaison® XL, Liaison® XL LAS and
Liaison® XL PMA.

During each service intervention, Field Service Engineer (FSE) and/or System Specialist (SS) has to
identify and check the root cause of the instrument failure (if any), and evaluate the related effect.
If the identified effect may lead to potential risks for the sample result and/or the end user, FSE /
SS is required to report the event to the reference Service Manager and to Corporate Service
department for the proper assessment.

3.1. SGAT ( for Subs ONLY )

Activities described in this Technical Note shall be tracked in SGAT according to the following
instructions.
3.1.1. Worksheet (WS) management
Track the activity with a “SW_UPGRADE” worksheet.
Attach the instrument requalification results listed at point 1, 2, 3 (BGW, LCL and LCR) of §6 to
the worksheet. It is not mandatory to attach the data listed at point 4 (three patient samples or
control).
It is not mandatory to attach the document Liaison® XL SW installation Check-List described at
§5.1.2 to the worksheet.
3.1.2. Additional information
After having completed the installation at §5.1, update the Machine Configuration as follows:
- Description: MAIN SOFTWARE VERSION
- Group: LXL SOFTWARE VERSION
- Subgroup: 4.2.1.1

3.2. For Distributors

The activity has to be tracked in a local traceability system.

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 Subject: Release of software version 4.2.1.1
ID Number: 172 Revision: A Date: 08/03/2018 Author: D.BELLUTO

4. Spare Parts
N.A.

5. Procedure
5.1. Installation procedure
The Liaison® XL SW installation procedure is described within the following document:
 XL-SDI-N11-T (171218) (Rev.C) Liaison XL SW V4.2.1 Installation Procedure.pdf
5.1.1. Important remarks for the installation
The software upgrade will reset the file ‘BottleTypes.txt’ (the system will not maintain the data
from the pre-existing version). Right after the installation, in case of customized sample rack,
check and update the ‘BottleTypes.txt’.

In a near future, new manufactured analyzers will be equipped with a Sample Bay Top
Cover (to comply with new requirements of EN 61010-1:2010 - Safety requirements for
electrical equipment for measurement, control, and laboratory use. General requirements). For
compatibility reasons, such hardware change will not allow anymore the usage of racks “C” and
“D”. Therefore, Liaison XL SW V4.2.1.1 disables by default the recognition of C.rac and D.rac
file.

NOTE – Sample Bay Top cover is NOT intended to be installed on currently installed analyzers.
For all analyzers without the sample Bay Top cover, the usage of racks “C” and “D” is still
allowed. Once the upgrade to Liaison XL SW V4.2.1.1 is performed, as also indicated in the
Liaison XL SW V4.2.1 installation procedure, in order to restore the correct recognition:
- Copy the C.rac and D.rac files present in the folder “D:\LiaisonXL\Data\9-pos” and paste them
into the folder “D:\LiaisonXL\Data”.
5.1.2. Installation Check-List
The Liaison® XL SW installation Check-List is available within the following document:
 XL-SDI-N33-T (171212) (Rev.A) LIAISON XL SW V4.2.1.1 Installation Check-List.pdf
This document is a guideline that could be used by FSE. It is not required to be attached to
SGAT WS record.

5.2. Downloads
The software package is available on FileZilla at the following path:
- Remote site: /DATA/LXL
- Filename: LXL_SW_Setup_4.2.1.1.zip

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 Subject: Release of software version 4.2.1.1
ID Number: 172 Revision: A Date: 08/03/2018 Author: D.BELLUTO

The patch for DS.bat is available on FileZilla at the following path:

- Remote site: /DATA/LXL
- Filename: LXL_Patch_for_DSbat_4.2.1.1.zip

5.3. User software changes

The official declaration for the Customer regarding the release of the new software version is
provided with the document:
 Declaration Liaison XL - Software V4.2.1.1 validated & contents (OS compatibility).pdf
The major changes introduced with the SW V4.2.1 are described in the documents:
- For ALL USERS (including DiaSorin’s personnel, Distributor’s personnel and Customers/End
Users)
 XL-SDI-N48-M (171220) (Rev.A) LIAISON XL Introduction to SW V4.2.1 (all users).pdf
Local organizations may translate the document in local language and disclose it to the
end user after local QA approval.

- For INTERNAL USERS (including DiaSorin’s personnel and Distributor’s personnel only)
 XL-SDI-N47-M (171220) (Rev.A) LIAISON XL Introduction to SW V4.2.1 (internal
users).pdf
Local organizations may translate the document in local language but it is NOT to be
delivered to the end user.

5.4. User documentation

Information about the user documentation is provided with the document:
 Technical Note 006 (TN 006)

5.5. Unsolved anomalies

The list of the unsolved anomalies for end user is provided with the document:
 Technical Note 033 (TN 033)
5.5.1. Important remarks
The unsolved anomalies of the former software version 4.2.0.2 are still valid also for software
version 4.2.1.1.

5.6. Customer Training

By using document “XL-SDI-N48-M (171220) (Rev.A) LIAISON XL Introduction to SW V4.2.1 (all
users).pdf”, inform the customer about the new SW features and about the new revision of
User manual.

6. Requalification
In order to re-qualify the analyzer after SW installation, perform the following tasks via User
Software logging in with the USER access rights:
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 Subject: Release of software version 4.2.1.1
ID Number: 172 Revision: A Date: 08/03/2018 Author: D.BELLUTO

1. A “Background” maintenance task

2. A “LC_Left” maintenance task
3. A “LC_Right” maintenance task
4. Three patient samples or control determinations using any assay
Steps at point 4. may be performed as a follow up activity of the user’s routine, i.e. the
FSE may not run them directly but follow the user’s routine ensuring the correct system
behavior.

The above-mentioned requalification procedure is also described in the document:

 XL-SDI-N11-T (171218) (Rev.C) Liaison XL SW V4.2.1 Installation Procedure.pdf

7. PPE
Picture of the PPE: Description of the PPE: Activity:
N.A. N.A. N.A.

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