EN LIAISON® QG 23 Reva

Quick Guide
According to Software Version 2.30
200/008-618,A-10/2010
200/008-618,A-10/2010
Quick Guide
Appendix to Quick Guide
Annexes (8)
DiaSorin Deutschland GmbH

von Hevesy-Strasse 3 D-63128 Dietzenbach
Tel. +49 .60 74.40 1.400 Fax +49 .60 74.40 1.420
E-Mail: information@diasorin.de
This document is referred to the highest access level.

Working with lower level access may cause lack of some functionalities.
Contents
1. Illustrations
Pag. 7
2. System daily usage procedure
Pag. 9
3. Definitions & glossary
Pag. 11
4. Preparations
Pag. 13
4.1. Switching on the system
Pag. 13
4.1.1. Normal
Pag.
4.1.2. 3 or more days of stop
Pag.
4.2. Switching off the system
Pag. 16
4.2.1. Normal
Pag.
4.2.2. 3 or more days of stop
Pag.
4.3. Replenishing system consumables
Pag. 18
4.3.1. Wash/System Liquid
Pag.
4.3.2. Starter Reagents
Pag.
4.3.3. Reaction Modules
Pag.
4.3.4. Waste tank
Pag.
4.3.5. Waste bag
Pag.
4.4. Integrals
Pag. 23
4.4.1. New Integrals
Pag.
4.4.2. Used Integrals not inserted
Pag.
4.4.3. Used Integrals already inserted
Pag.
4.5. Loading in Reagent Area
Pag. 24
4.6. Samples
Pag. 26
4.6.1. Rules for all sample types
Pag.
4.6.2. Patient samples
Pag.
4.6.3. Light Check
Pag.
4.6.4. Controls
Pag.
4.6.5. External calibrators (only for certain kits)
Pag.
4.7. Loading in Sample Area
Pag. 28
4.7.1. Opening Sample Area
Pag.
4.7.2. Loading racks
Pag.
4.7.3. Closing Sample Area
Pag.
4.7.4. Error messages
Pag.
4.8. Saving data
Pag. 35
4.8.1. Use
Pag.
4.8.2. Procedure
Pag.
13
15
16
17
18
19
21
22
22
23
24
24
26
27
27
27
28
28
28
32
32
35
35
4.9. Electronic Instructions for Use

4.10. Centering pipettor needles
Pag. 37
Pag. 39
5. Checking instrument status

5.1. Consumables
5.1.1. Wash/System Liquid, Starter Reagents
and Reaction Modules
5.1.2. Temperatures and voltages
5.1.3. Waste tank Waste bag
Pag. 41
Pag. 41
6. System Test
6.1. Loading racks
6.2. Selecting tests
6.3. Evaluating results
Pag. 45
Pag. 45
Pag. 45
Pag. 46
7. Using and calibrating a kit

7.1. Loading a kit
7.2. Checking calibration status
7.3. Calibration
7.4. Finishing use of a kit
Pag. 49
Pag. 49
Pag. 49
Pag. 50
Pag. 53
8. Running tests
Pag. 55
9. Managing results
9.1. Displaying results
9.2. Validating results
9.3. Daily Lab Journal and Valid menu
Pag. 59
Pag. 59
Pag. 60
Pag. 60
10. Routine maintenance

10.1. Daily maintenance
10.1.1. Clean the instrument
10.1.2. Check system liquids
10.1.3. Save data
10.2. Weekly maintenance
10.2.1. Switch off the system
10.2.3. Switch on the system
10.2.5. Center pipettor needles
10.2.6. Save data
Pag. 63
Pag. 63
Pag.
Pag.
Pag.
Pag. 64
Pag.
Pag.
Pag.
Pag.
Pag.
Pag.
Pag. 41
Pag. 42
Pag. 43
63
63
63
64
64
64
64
64
64
10.2.7. Depletion of "Message box"

Pag. 64
10.2.8. CLEAN Tool
Pag. 65
10.3. Monthly maintenance
Pag. 66
10.3.1. Switch off the system
Pag. 66
10.3.2. Differential Switch functionality testing
Pag. 66
Pag. 66
10.3.4. Switch on the system
Pag. 66
10.3.5. Decontamination and fluidic cleaning
Pag. 67
Pag. 69
10.3.7. Center pipettor needles
Pag. 69
10.3.8. Save data
Pag. 69
Pag. 69
10.3.10. Wash / System Liquid container cleaning procedure
Pag. 69
1. Illustrations
Legend
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
14.
15.
16.
17.
Pipettors (left & right)

Cuvette loader
Stacker
Sample Area
Reagent Area
Incubator loader
Washer loader
Incubator
Washer transport
Washer lift
Diluters (left & right)
Back-transport
Pusher
Measure chamber
Barcode reader
Waste bag
Starter Area
Teacher
Legend
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
(with consumables part numbers)

Light Check
Starter reagents
Wash/System liquid
Integrals
Reaction modules
Wash/System liquid tank
Waste tank
A rack
C rack
L rack
P rack
Waste bag
(319101)
(319102)
(319100)
(319130)
(450003)
2. SYSTEM DAILY USAGE PROCEDURE

LIAISON may only be used by authorised personnel.
In the event of problems or doubts about using the system,
contact the Technical Assistance Service.
1. If the 3 or more days of stop procedure has been carried out on the system,
follow the procedure listed at point 4.1.2.
2. With the system on, switch on the monitor and load the necessary integrals into the
Reagent Area (see chap. 7). They must shake for at least 30 before any use.
3. Carry out an instrument check (see chapter 5).
4. Carry out a System Test and check the results obtained (see chapter 6).
5. After the integrals have been shaking into the Reagent Area for at least 30,
calibrate them if necessary (see chap. 7).
6. Run tests (see chapter 8), validate and print the results (see chapter 9).
7. Repeat steps 5 and 6 as necessary until the end of the work session.
8. Upon finishing the session, check the LIAISON user maintenance report form
(annexed) and, if necessary, carry out monthly or weekly maintenance, otherwise
carry out daily maintenance (see chap. 10); fill in the form. Monthly maintenance
already includes both weekly and daily maintenance procedures, which are thereby
automatically carried out. Weekly maintenance also includes all daily maintenance
procedures.*
9. For short periods of inactivity (for example, overnight and weekends) switch
off the monitor, keeping PC and instrument on.
For periods of inactivity of 3 days or more, follow the procedure shown in
point 4.2.2. This procedure is recommended also for periods of inactivity of minor
length (for example, weekends).
10. Prepare the Wash/System Liquid for next session (see point 4.3.1).
*Note: maintenance can be carried out at any time between two work sessions. It is
recommended to carry out maintenance either in the morning or evening, to avoid
interrupting daily work sessions. Failure to carry out maintenance or incorrect
maintenance procedures will jeopardise test results and cause interruptions
in daily sessions to allow for extra maintenance interventions.
10
3. DEFINITIONS & GLOSSARY

System: The complete structure installed in the lab
Instrument: Part of LIAISON System that contains only the LIAISON

Analyzer and two tanks, but not PC, printer and cables
Prime: Start-up cycle for individual parts of instrument involved in fluidics,

carried out by usage of Wash/System Liquid and Starter Reagents
Clearing: Initialization cycle to eliminate Reaction Modules in the instruments
paths
Kit: Set of consumables used to carry out a specific assay; in some cases, as
well as the Integral it has 2 external calibrators
Samples: Anything that can be introduced by operator into Sample Area racks,
including patient samples, controls, Light Check and external calibrators
Back Transport
Barcode Reader
BGW
Chamber Lift
Chamber Transport
Cleaning Kit
Cuvette Loader
CV%
Geometric curve check
Incubator
Incubator Loader
Integral
LC-le
Moves the reaction module back from pusher

to incubator for next incubation
Assembly to read the barcode
Test to check quality of instrument washing
Dispensation head of starters
Moves the reaction module inside into the
measure chamber
A kit used for maintenance, made of:
CLEAN Solution, to clean needles
PUMP Solution, to clean starter pumps
Two belts to transport reaction modules into
the Stacker
Statistical variable that shows dispersion rate
of measurements
Disqualification criterion for a calibration,
based on a range in which a certain geometric
figure must lie.
16 position assembly in which reaction
modules are incubated
Moves reaction modules from the first
pipetting position to the incubator
Reagent cartridge (made up of vials) to be
inserted into the Reagent Area
Test to verify accuracy of the left dispensing
pipettor, carried out by Light Check solution
11
LC-ri
Light Check
Measurement Chamber
Pipetting areas
Pusher
Rack (Patient Rack)
Reaction module
Reagent Area
RLU
Sample Area
Signal Range
Stacker
Starter reagents (Starters)
Teacher
Temperature: Air
Temperature: Reagent
Vial
Wash Station
Wash/System Liquid
Washer Lift
Washer Loader
Washer Transport
Waste bag
Test to verify accuracy of the right dispensing

pipettor, carried out by Light Check solution
Control provided as lyophilised material
Reading area in which chemical reaction and
measurements occur
Dispensation area for samples and reagents
Transports reaction modules to back-transport
or measure chamber
Module to be filled with sample tubes (9 or 12
positions)
Plastic module consisting of 6 cavities in which
immunometric reaction can take place
Integral loading area
Relative
Light
Unit
(signal
strength
measurement unit)
Sample lodging area
RLU range in which results for a specific assay
must lie
Magazine (7 levels) in which reaction modules
are stored inside the instrument
Reagents dispensed during the readings to
generate chemiluminescente signal
Tool to check centering of pipettor needles
Environment temperature
Reagent Area cooling temperature
Container for just one reagent; more vials
form an integral
Each of the two washing wells for pipettor
needles
Solution (to be diluted 1:10 in distilled H20)
used to wash pipettor needles and reaction
module cavities
Mobile washing head for reaction modules
Moves reaction modules from incubator to
Washer Transport
Transports reaction modules underneath the
Washer Lift, in one cavity per time steps
Container for used reaction modules
12
4. PREPARATIONS
4.1. Switching on the system

4.1.1.
Normal
4.1.1.1.
Switch on PC, Monitor, and Printer.
4.1.1.2.
Run LIAISON
4.1.1.3.
The following window appears:
4.1.1.4.
Type user name and password, then wait for the following message
to appear:
4.1.1.5.
Switch on the instrument and wait for the LEDs in Sample Area
guides (not occupied by any racks) to change to green.
program pressing the icon
on desktop.
13
4.1.1.6.
4.1.1.7.
Then click the

priming.
icon and await initialisation, clearing and
During initialisation, it is possible that the following message appear:
it informs that the system is starting to shake the magnetic particles

and so integrals are not ready for use. Confirm with
4.1.1.8.
Attention!
While the instrument is initializing, it is forbidden to touch
any part of it (opening flaps, exchanging bottles, ),
otherwise the following routine could be affected.
14
4.1.1.9.
Lastly, the main menu window appears:
4.1.1.10. Attention!
The instrument must remain on for at least 1 hour before
starting use (after power has been off for 30 or more).
4.1.2.
3 or more days of stop
4.1.2.1.
Attention!
This procedure must be carried out also after a short period of
inactivity, if the procedure 4.2.2 was previously carried out.
4.1.2.2.
Substitute distilled H2O bottles with Starters bottles.
4.1.2.3.
Substitute the tank of distilled H2O with a tank containing

Wash/System Liquid (see 4.3.1).
4.1.2.4.
If the system is off, switch on according to 4.1.1.
4.1.2.5.
The first time that a System Test will be carried out (see 6.2), it
should be ran at least twice with values given in the 2 columns of
table below:
15
Section
Type
Cycles
Pipettor
Washer
Chamber Set A
BGW
LC - le
LC - ri
Reaction modules
Values Values
1st run 2nd run
10
10
10
0
0
0
10
10
10
1
1
1
4.2. Switching off the system

4.2.1.
Normal
4.2.1.1.
From the main menu select
4.2.1.2.
The following window appears :
select
16
4.2.1.3.
From the window:
select
4.2.1.4.
If the system will not be used for several hours, switch off the
monitor.
4.2.1.5.
If the system will not be used for a long time, remove integrals and
switch off instrument, PC and printer.
4.2.2.
3 or more days of stop
4.2.2.1. Attention!
It is possible to carry out this procedure for short periods of
inactivity too (for example, during weekends).
4.2.2.2. When the work session is finished, substitute Starters with two
distilled H2O bottles, preferably at 35 40 C.
4.2.2.3. Substitute Wash/System Liquid with distilled H2O.
4.2.2.4. Run a System Test selecting the values at least equal to the
following (see 6.2):
Section
Type
Values
Cycles
4.2.2.5.
Pipettor
10
Washer
10
Chamber Set A
10
Reaction modules BGW
0
LC - le
0
LC ri
0
The normal switching-off procedure can now be initiated (see 4.2.1).
17
4.3. Replenishing system consumables

4.3.1.
Wash/System Liquid
4.3.1.1.
Attention!
Wash/System Liquid can only be replenished when the
system is ON but inactive, meaning when no tests are
running.
4.3.1.2.
The deionised water to be used for the dilution of the Wash/System

Liquid should be defined according to CLSI guidelines for laboratory
water, Instrument Feed Water type (<5 S/cm or > 0,2 M). The
water should not come from a stock container where moulds or
sediments could be present.
4.3.1.3.
Attention!
The use of water of an inadequate quality may cause
anomalous Background and LightCheck values.
4.3.1.4.
Prepare Wash/System Liquid pouring 9 L of distilled H20, then add a
bottle labelled as LIAISON Wash/System Liquid (1 L) taking care to

minimize presence of foam.
4.3.1.5.
Leave the tank to settle for at least 6 hours without connecting it to

the instrument.
4.3.1.6.
If a previously used tank is refilled, wait 6 hours anyway before using

again.
4.3.1.7.
Connect the tank to the instrument.
4.3.1.8.
Run a System Test, selecting the values at least equal to the

Section
Type
Cycles
Pipettor
Washer
Chamber Set A
BGW
LC - le
LC - ri
Reaction modules
Values
10
10
3
1
1
1
18
4.3.2.
Starter Reagents
4.3.2.1.
Attention!
Starters can only be replaced when instrument is inactive,
meaning no tests are running.
4.3.2.2.
Remove cover from Starter area.
4.3.2.3.
Remove used bottles and replace them with fresh bottles, as

illustrated below:
taking care to insert Starter LIAISON
1 in position A1 and/or
Starter LIAISON 2 in position A2, respecting right connections (the

tubes have labels for the corresponding colors of each position).
4.3.2.4.
Attention!
Starter pooling is prohibited.
The area concerned bears the following label:
4.3.2.5.
When this procedure is finished, replace the Starter area cover.
19
4.3.2.6.
Run a System Test, selecting the values at least equal to the

Section
Type
Cycles
Pipettor
Washer
Chamber Set A
BGW
LC - le
LC - ri
Reaction modules
Values
3
3
10
1
1
1
4.3.2.7.
Attention!
In case the batches of old and new Starter were different, it is
necessary to recalibrate all the kits (see Chapter 7).
4.3.2.8.
In case it is necessary to check the level of remaining liquid into

starter bottles, the following cautions have to be respected:
o
o
o
The bottle shall not be reversed upside down

The bottle shall not be shaken and has to be tilted only the essential
The bottle shall not loose contact with the walls of the starter tray:
Bottle is kept in touch

with the starter tray
20
The starter level capacitive LED shall remain on:
Starter Level LED

is ON
4.3.3.
Reaction Modules
4.3.3.1.
Use only DiaSorin approved Reaction Modules.
4.3.3.2.
Insert Reaction Modules on the Stacker belts when not in motion,

taking care to seize at least 4 Reaction Modules and to leave the
longest side of the 6 cavities facing the instrument, as illustrated
below:
4.3.3.3.
About once a month, let the instrument work without loading Reaction
Modules. When the following message appears:
21
start again loading Reaction Modules.

4.3.3.4.
4.3.4.
The stacker should possibly be filled prior the starting of the routine,
limiting the necessity to add new reaction modules while the analyzer
is working and as consequence also limiting the operator intervention.
Waste tank
Empty the waste tank, and afterwards its recommended to add 200 mL
of commercial hypochlorite or bleach.
4.3.5.
Waste bag
Substitute the waste bag when full (100 Reaction Modules), then push
the button
(see also 5.1.3).
22
4.4. Integrals
ATTENTION!
Please check that the handle is correctly aligned with the
reagent integral before loading into the analyzer. Please contact
your local DiaSorin Technical Service if you have any questions.
1. Right
2. Wrong
4.4.1.
New integrals
If the kit is new, or it has been used and placed in a refrigerator for
storage, before inserting check:
4.4.1.1.
that the covers have been removed from each vial;
4.4.1.2.
that no foreign material or liquid is present on the vial membranes;
4.4.1.3.
that the vials contain no bubbles.
23
4.4.2.
Used Integrals not inserted

If the kit has been used before and stored in the refrigerator, before
inserting it into the instrument, check:
4.4.2.1.
that no foreign material or liquid is present on vial membranes;
4.4.2.2.
that vials have no bubbles.
4.4.3.
Used Integrals already inserted

If the kit is already inserted in instrument, check:
4.4.3.1.
that no foreign material or liquid is present on vial membranes;
4.4.3.2.
that it is properly fitted and fastened inside reagent area (magnetic

particle vial rotating); if not fastened, leave inserted for 30 minutes.
4.5. Loading in Reagent Area

4.5.1.
Attention!
No integral can be extracted while active, meaning with its
number on a red background (see Annex Symbols associated
with integrals).
Furthermore, Sample Area & Reagent Area doors must never
be open at the same time .
24
4.5.2.
Open Reagent Area door and automatically the corresponding menu will
appear:
4.5.3.
Attention!
If an integral of the same test is already inserted, insert the new
integral in a guide more to the right of the placed integral.
4.5.4.
Load the Integral with a continuous motion, until it locks at the end of
the lane.
4.5.5.
If the following message appears:
extract the Integral and repeat loading.

4.5.6.
Check that the Integral is well inserted, the barcode reads correctly and
the kit has the right name.
25
4.5.7.
Close the Reagent Area door and allow the newly inserted kit to agitate
for at least 30 minutes. The remaining time is below each integral
picture.
4.5.8.
In case the barcode scanner is not working, see the procedure listed in
4.7.5
4.6. Samples
4.6.1.
Rules for all sample types
4.6.1.1.
Only use sample holders and patient racks authorized by DiaSorin and
comply to the following specs:
rack type
B
W
E
F
I
A
J
K
N
Q
X
Y
Z
C
L
P
use
15 mm (internal diameter)
only for DiaSorin control special vials
only for DiaSorin glass vials
(e.g. Light-Check)
only for Eppendorf pediatric tubes
4.6.1.2.
Remove covers from sample holders (if present).
4.6.1.3.
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 L plus the volume required to run the test.
4.6.1.4.
Check for and remove air bubbles.
26
4.6.1.5.
4.6.2.
Attention!
Air bubble formation or clotting of the samples must be
avoided as these may alter the liquid detection functionality
and hence cause unreliable results.
Patient samples
4.6.2.1.
Check for the absence of clots and threads.
4.6.2.2.
Apply the bar-code at the correct height.
4.6.2.3.
Insert the samples in the correct rack, filling each slot starting at the
first slot, ensuring that the bar code is clearly visible through the side
opening of the rack.
4.6.2.4.
Each sample tube has to be inserted in the rack till the bottom of the
rack itself.
Tubes must not be kept raised
4.6.3.
Light Check
4.6.3.1.
Reconstitute the Light Check.
4.6.3.2.
Insert the reconstituted Light Check bottle into the first slot of a rack
L, ensuring that bar code is clearly visible through the side opening
of the rack.
4.6.4.
Controls
4.6.4.1.
If necessary, reconstitute controls (see the respective Instructions for

Use).
4.6.4.2.
If it is not possible to insert control bottles in any rack, transfer the

contents into sample tubes approved by DiaSorin or in bottles as the
ones used for Light Check (order# 9515281), applying the bar-code
if available.
4.6.4.3.
Insert the controls into a proper rack (rack A for tubes of the same
type as used for patient samples, rack C for special size bottles, rack
27
L for bottles as the ones used for Light Check).
4.6.5.
External calibrators (only for certain kits)
4.6.5.1.
Prepare calibrators as explained in documentation provided with the

kit.
4.6.5.2.
If necessary, apply bar-code at the correct height.
4.6.5.3.
Insert calibrators into a proper rack, making sure the bar code is
clearly visible through the side opening of the rack.
4.7. Loading in Sample Area

4.7.1.
Opening Sample Area
With the Reagent Area door closed, open the Sample Area door; the following
window will appear:
4.7.2.
Loading racks
Attention! Before inserting the rack, it is necessary to wait for the

barcode beam to activate
28
4.7.2.1.
Insert the rack in a lane of the Area with continuous motion. If a Light
Check or a CLEAN Tool have to be run, select a lane between 10, 11
or 12. In case of error, see 4.7.4.
4.7.2.2.
Repeat step 4.7.2.1 for all necessary racks.
4.7.2.3.
Afterwards the occupied positions of Sample Area are displayed in the

Rack Station area, as illustrated below:
by selection of a single rack, the samples present in each rack position

can be viewed.
Note: enabled positions may be 9 instead of 12.
4.7.2.4.
For every sample inserted, it is possible to verify its characteristics

through the colored circles beside the position numbers (id colour)
and in the Sample-ID column (sample code).
The sample code consists of a possible identification symbol,
followed by the proper identification and, for Light Checks and
external calibrators, another identification symbol and information
about calibrator.
The following table correlates sample types and related identification
colours and symbols:
29
Sample type
Identification Identification
symbol
color
Patient with
normal priority
1234
Patient with
STAT priority
1234
Light Check
External
calibrator
Control
4.7.2.5.
Example
$LC-$
$S100$A17.0
#1234
If the barcode is absent or not readable, the corresponding sample

can be manually entered, selection the position in the rack and
proceeding as follows:
4.7.2.5.1.
4.7.2.5.2.
for patient samples:
from the keyboard, key-in the sample code, following the

conventions given in 4.7.2.4:
press TAB or ENTER and type again the sample code;

the first entry is blind;
as soon as the system verifies that the same value has

been entered twice, a blue box surrounds the field:
press TAB or ENTER to confirm and leave the field;
for Light Check:
press the icon
from the assay list on the right, select LC-le:
30

4.7.2.5.3.
4.7.2.5.4.
for external calibrators:
press the icon
from the assay list on the right, select the related test;
from the keyboard, complete the sample code, following

the conventions given in 4.7.2.4 and the related
Instruction for Use;
press TAB or ENTER and type again the first entry, that
is blind;
as soon as the system verifies the correct entry, a yellow

box surrounds the field:
for controls:
press
; the following window will appear:
31
select the required control from the list and confirm by

pressing
; if the list doesnt show the control, it
will be necessary to add it (see C.2);
the following window will appear on the right:
in which it is possible to select the field Start in next

run, and then to select the tests to be associated to the
control, that will be performed when pressing
4.7.3.
Closing Sample Area
Close the Sample Area and proceed with operations.
4.7.4.
Error messages
4.7.4.1.
If one or more positions on the inserted rack are empty or the

barcode is absent or damaged, the following message appears:
32
Reply with
4.7.4.2.
and check the position of each barcode.
If the Rack itself is not correctly inserted into the Sample Area, the
system then gives one of the following messages:
In this case, extract the rack from the Sample Area and re-insert it.
33
4.7.5.
Barcode Scanner Recovery

In case the barcode scanner is not working, it is possible to perform
the following steps to try to recover:
Press the button
Press the button
The following dialog will appear:
Type the string 2A 48
Press the button
and then confirm with
34
4.8. Saving data

4.8.1.
Use
4.8.1.1.
This procedure saves current system status, and specifically:
4.8.1.2.
The procedure is used in two different situations:
4.8.2.
both validated and not validated results;

data on the racks present in the Sample Area;
data on the integrals present in the Reagent Area;
assay and control related information;
calibration data;
"Message box".
to save the work on a daily basis;

to allow Technical Assistance to check system behaviour.
Procedure
4.8.2.1.
In case of involving Technical Assistance, make sure that all integrals

involved in current problem are present on board and recognized by
the system. If an integral is no longer available, replace it with one
from the same lot.
4.8.2.2.
Exit the software (following steps 4.2.1.1 to 4.2.1.3).
4.8.2.3.
Insert a writable floppy disk in the floppy drive or insert a USB stick in
a free USB port.
4.8.2.4.
Open the LIAISON

appear, as shown:
Tools folder on the desktop; its content will
35
4.8.2.5.
Select
. This opens the window:
4.8.2.6.
In case a USB stick is used, it is necessary to browse to the right

folder (usually E:\ or F:\)
4.8.2.7.
Highlight the File Name: field and key-in a name for the new file
(for example, 713data where 713 are the last 3 numbers of the
instrument serial number) and press
.
Attention: the file name is limited to a maximum of 8
characters long.
4.8.2.8.
Once saved, the LIAISON Tools menu reappears. Remove the

floppy disk and store it correctly.
4.8.2.9.
Enter again the software (following steps 4.1.1.2 to 4.1.1.8).
4.8.2.10. It's possible to delete the content of the Daily LabJournal (see
9.3).
36
4.9. Electronic Instructions for Use

4.9.1.
Electronic Instruction for use (if mini CD is available) can be accessed

directly from LIAISON software:
1 = Instructions for use for Kits
2 = Instructions for use for Controls
3 = Barcode Information and Symbols (as a link at the bottom of
Barcode Information)
3
1
2
4.9.2.
The appropriate language (given by appropriate language setting) will be

automatically searched in the mini-CD.
4.9.3.
In case no electronic IFU are available in CD-ROM, the following pop-up

is displayed:
37
4.9.4.
The Instructions for Use can be also printed (pressing
):
38
4.10. Centering pipettor needles
4.10.1.
From the main menu select
4.10.2.
The following window appears :
select
4.10.3.
and then
39
4.10.4.
With the Sample Area empty, place the Teacher (Reference Tool) in
the far right corner of the patient area as shown in the picture:
Ensure that the Teacher is tight against both the back and right side
wall of the patient area.
4.10.5.
Select
and then
4.10.6.
If the needle is not centered over the white dot on the top of the
Teacher, lightly bend the needle until it is centered.
Attention!
Its necessary to wear protective gloves to touch the needles.
4.10.7.
Select
4.10.8.
Confirm with
and then
and repeat previous step.
40
5. CHECKING INSTRUMENT STATUS

5.1. Consumables
check the three icons present to the lower right of the screen:
all three icons must be green, otherwise, certain consumables are missing or the
instrument is malfunctioning.
5.1.1.
Wash/System Liquid, Starter Reagents and Reaction

Modules
5.1.1.1.
The first icon to the left shows the presence of: Wash/System Liquid,
Starter Reagents and Reaction Modules. Specifically:
: the three components are present in sufficient quantities;
: one of the three components is about to finish;
: one of the three components is finished.

5.1.1.2.
The quantity of consumables still present on board can be obtained

with the following table:
41
Consumable
Color
Wash/System Liquid
Starter Reagents
Reaction Modules
5.1.1.3.
Available quantity
at least 2 L
less than 2 L
about 20 of working time after
turning yellow
at least (about) 50 mL
less than (about) 50 mL
about 20 of working time after
turning yellow
at least 15
less than 15
If the icon is in one of the last two conditions, click on it. This opens
the window below:
The example shows that the two Starters (indicated as Triggers A1

and A2), and the Reaction Modules are green and thus intervention
is not required, whereas the Wash/System Liquid shows yellow and
must be replenished (see 4.3).
5.1.2.
Temperatures and voltages

The second icon to the left indicates the temperature in the instrument
and supply voltage status. Specifically:
: all temperatures and voltages are within specified parameters;
: one temperature or voltage is outside specified range.
42
If the icon is in the latter state, click on it to open the window below:
The incorrect values are indicated in red. The parameter MP Rotation

Speed is Off-Range is enabled in case of malfunctioning of the
magnetic particle shaker. If the values do not become acceptable within
a short time (at most 30 minutes), contact the Technical Assistance
Service.
5.1.3.
Waste Tank Waste bag
5.1.3.1.
The third icon to the left indicates the condition of waste tank (liquid
container) and waste bag (reaction module container). Specifically:
: both the containers are not full;
: at least one the two containers is almost full;
: at least one the two containers is full.
5.1.3.2.
The state of emptiness of the containers can be obtained with the

following table:
43
Waste
Waste tank
Waste bag
5.1.3.3.
Color
Status
less than 8 L
between 8 L and 9 L
more than 9 L
less than 90 Reaction Modules
between 90 and 99 Reaction Modules
more than 99 Reaction Modules
If the icon is in one of the last two conditions, click on it to open the
window below:
This confirms that the tank needs emptying (see 4.3.4 4.3.5).
44
6. SYSTEM TEST
6.1. Loading racks
6.1.1.
Prepare the Light Check and insert it in a rack L (see 4.6).
6.1.2.
Insert the L rack containing the reconstituted Light Check in one of lanes
10, 11 or 12 in the Sample Area (see 4.7).
6.2. Selecting tests
6.2.1.
Press
to carry out session start controls.
6.2.2.
The following menu appears:
where:
Pipettor
Washer
Chamber Set A
BGW
LC-le
Lc-ri
6.2.3.
is
is
is
is
is
is
the
the
the
the
the
the
number
number
number
number
number
number
of
of
of
of
of
of
primes of the two pipettor probes

primes of the washer head
primes of the DiaSorin starters
Background tests
Lc-le tests
Lc-ri tests
The minimum necessary values are given in the following table:
45
Cycles
Normal
Before 3 or more days of non - activity
After 3 or more days of non - activity:
- run 1
- run 2
Replace Starters
Monthly maintenance:
- H20 Hypochlorite
- PUMP Solution H20
- H20 H20
- Starters System Liquid run 1
- Starters System Liquid run 2
Reactionmodules
Pipettor
3
10
Washer
3
10
Chamber
Set A
3
10
BGW
1
0
LC - le
1
0
LC - ri
1
0
10
10
3
10
10
3
10
10
10
0
1
1
0
1
1
0
1
1
10
10
10
10
10
10
10
10
10
10
10
10
10
10
10
0
0
0
0
3
0
0
0
0
3
0
0
0
0
3
Attention!
Never select more than 10 cycles for each assembly.
6.2.4.
In normal operating conditions the default values are correct.

Otherwise select suitable values, following the steps given in the
chapters corresponding to the actual situation.
6.2.5.
Press
6.3. Evaluating results

6.3.1.
Upon finishing the System Test, check that the results meet the
following specifications:
6.3.2.
6.3.3.
6.3.4.
BGW:
120 < RLU < 320;
CV% < 8
LC :
120000 < RLU < 180000;
CV% < 2.5
Difference LC-le LC-ri %
see table in 6.3.5
where the Difference LC-le LC-ri % represents the ratio of the
difference between the left and right Light Check and the average of the
two.
Note that the condition given in point 6.3.3 must be met by both Light
Checks (LC-le and LC-ri).
46
6.3.5.
To meet point 6.3.4. use the following table (in R.L.U.):
If the average of LC-le e LC-ri is

then their difference must
not exceed
6.3.6.
greater than
and less than
120000
130000
6000
130000
140000
6500
140000
150000
7000
150000
160000
7500
160000
170000
8000
170000
180000
8500
If the test results are in specifications, it means that the system has
correctly completed the following steps:
washing;
dispensing with both pipettor probes;
dispensing of starters;
reading.
6.3.7.
In the event of incorrect results, return to step 6.2 selecting only the
tests that did not produce acceptable results; if the problem persists,
contact Technical Assistance Service.
6.3.8.
Attention!
The rack cannot be extracted when in use, meaning when
its Sample Area LED is red.
6.3.9.
At this point open the Sample Area, extract the L rack, close the
Sample Area and carry out a work routine.
6.3.10.
It is recommended to mark out the results referring to the System Test,

by printing daily (see 9.3) and filing them.
47
48
7. USING AND CALIBRATING A KIT

7.1. Loading a kit
7.1.1.
If the kit is new, prepare it as instructed in 4.4.1, then load it as

described in 4.5.
7.1.2.
If the kit has already been used and stored outside the instrument,
prepare it as indicated in 4.4.2, then load it as described in 4.5.
7.1.3.
If the kit has been used and stored in the instrument, make the checks
described in 4.4.3.
7.1.4.
Attention!
Kits must be inserted one at a time, ensuring that each one is
correctly recognized before proceeding with the next.
In case different integrals for the same assays are present, the
priority is established according to remaining shaking time and
then to lane order (the farthest left first).
7.2. Checking calibration status

7.2.1.
From the main menu, select the Reagent Area to display the
corresponding menu:
49
7.2.2.
Use the two LED's (circled in yellow in previous picture) to check the
calibration status of each individual kit on board:
the left LED indicates calibration status (green: a valid calibration is
present; red: no valid calibration is present);
the right LED indicates calibration in progress (green: calibration
complete but not yet validated; red: calibration in progress; off: no
calibration in progress).
Thus the normal working condition is
7.3. Calibration
If the integral has to be calibrated:
7.3.1.
Select the integral to be calibrated; if the integral has external calibrators,

prepare them and insert them in the appropriate rack (see 4.6) and load
the rack into the Sample Area (see 4.7).
Attention:
for kits using the Shared Working Curve feature, only one
integral of a particular lot number is to be inserted onto the
system during a calibration run.
7.3.2.
Press
calibration.
in the Reagent Integral Area window to start integral
7.3.3.
In case a refill action was occurred or the analyzer was idle for too long,
the following window appears:
50
after pressing
, the system will perform primes.
After the primes are completed, the following popup will appear:
After pressing
, press
again to start the calibration.
Attention:
If the button
not start!
is not pressed again, the calibration will
51
7.3.4.
Upon finishing calibration (right LED is green), press

to define
the Working Curve (representing the results of the calibration).
7.3.5.
Press
to calculate and plot the Working Curve on the screen,
highlighting all information related to the curve itself (if there is a
previous calibration, the old one is displayed until pressing
7.3.6.
).
Attention!
The new Working Curve will not be calculated and displayed
until
is pressed.
7.3.7.
It is possible to print a "Calibration Report" pressing
7.3.8.
Then select Validate and Recalc Associated Samples.
7.3.9.
Confirm with
In this way:
52
the newly plotted Working Curve is rendered valid and active;
calibrator doses are calculated according to the new Working

Curve;
if there are samples present in the Daily Lab Journal

previously tested with the same integral, these are recalculated
according to the new Working Curve.
7.4. Finishing use of a kit

7.4.1.
Attention!
An integral currently being used is not to be extracted (refer to
Annex Symbols associated with integrals for related
information).
7.4.2.
Upon finishing use of a kit, it is possible to open the Reagent Area,

extract it and close the Area. If external calibrators have been used,
open the Sample Area, extract the rack and close the Area again.
7.4.3.
The Integral can always be kept on board with the instrument on,
provided that the temperatures are correct (see 5.1.2).
53
54
8. RUNNING TESTS
Attention!
If an On-Line communication protocol is enabled, the running test
procedure may differ from the following description (see App. D).
8.1.
Prepare the racks with the samples (see 4.6).
8.2.
Insert the racks in the Sample Area (see 4.7).
8.3.
Attention!
The doors in the Sample Area and Reagent Area must never be
opened at the same time.
8.4.
Assign every sample to the required tests as follows:
8.4.1.
From the Main menu, click on the Sample Area symbol:
(only if the Sample Area door is not open).

8.4.2.
The following window will appear:
Vertical bar
55

8.4.3.
Select the required sample, or select all the samples in the present rack
by clicking on the vertical bar (see picture in 8.4.2).
8.4.4.
Use the arrows

in the test area to view the test list; the tests
present on board will be shown as dark grey.
8.4.5.
Select the tests required for the selected samples. The LEDs of the
selected buttons turn from red (
8.4.6.
Press
Press
) to green (
).
to display the tests assigned to all the samples in the rack.

to select further tests for samples in the rack.
8.4.7.
For use of the STAT and Dilute functions, see App. A.
8.4.8.
Close the Sample Area door (or press

if the door is already
closed) when all the samples have been programmed.
8.5.
Start the programmed tests by pressing
8.6.
In case a refill action was occurred or the analyzer was idle for too long, the
following window appears:
after pressing
from the main menu.
, the system will perform primes.
56
After the primes are completed, the following popup will appear:
After pressing
, press
again to start the programmed tests.
Attention:
If the button
tests will not start!.
8.7.
is not pressed again, the programmed
Attention!
The Rack cannot be extracted during operation, meaning when the
LED in the Sample Area is red.
Extract only when the green LED is on.
57
58
9. MANAGING RESULTS
9.1. Displaying results
9.1.1.
Pressing
from the main menu, followed by
displays test
programming (list of performed tests, of scheduled tests with completion
time and results) as illustrated below:
9.1.2.
The sample may be in any of the following states:

PLACED the sample has been scheduled but not yet tested;
ACTIVE the sample is under test;
TO DO the routine was running but interrupted or the sample is not
present;
FAILED the test has been terminated without producing results.
9.1.3.
At the end of a successful routine, an RLU value is obtained, along with a

concentration value and, for certain tests, a label is also produced.
9.1.4.
Pressing
opens the following window:
59
select the results sorting criteria (in the Sort Criterion field) and the
order direction (in the Order field); confirm with
9.2. Validating results

9.2.1.
Results can be validated (moving them from the Daily LabJournal to

the Valid menu) by selecting the samples with F7 (if validation is
required only for a number of samples), then finally pressing
The selected results are automatically moved into the Valid menu,
accessible from the main menu by pressing
Note:
Daily validation of the Daily LabJournal results is recommended, to
avoid filling the system database.
9.3. Daily Lab Journal and Valid menu

Attention!
If an On-Line communication protocol is enabled, the Daily Lab
Journal and Valid menu may differ from the following description (see
App.D).
60
9.3.1.
The difference between the Daily Lab Journal menu and the Valid
menu is that the first contains the work list and is continually updated,
while the latter contains validated results only.
9.3.2.
In both menus it is possible to:
9.3.2.1.
SELECT tests by highlighting them and pressing F7 ;
9.3.2.2.
PRINT pressing
9.3.2.3.
DELETE a result pressing
9.3.2.4.
VIEW the results to check each individual determination and a
;
;
description of any errors, by pressing
when in the Daily Lab
Journal menu or
from the Valid Menu (in the Daily Lab
Journal there are also kit and Master Curve traceability data);
9.3.2.5.
SORT the results in chronological order, by test, by patient ID by

pressing
9.3.2.6.
9.3.3.
COMMUNICATE with the central system (see App. D);
From the Daily Lab Journal menu it is also possible to:
9.3.3.1.
9.3.4.
VALIDATE a result (see 9.2).
To print, delete or validate one or more results, after pressing the

corresponding icon, a window similar to the following appears:
61
where the following fields may be selected (where available):

if the required samples have been selected
(with F7 )
All
to work on all samples
All without flag
to work on all samples without flags
All Samples
to work on all patient and control samples
All samples without flag to work on all patient and control
samples without flags
From..To
not operative
Redirect to file
to send the content to a file
(select format, choosing between Text and
Excel, then insert a floppy disk into the drive
and type the file path in the filename field,
for example a:\data to obtain a filed named
data on the disk
Tagged
confirm with
and, if required, with
62
10. ROUTINE MAINTENANCE
ATTENTION!
In all types of maintenance, the Starters must never be pooled,
but rather totally substituted.
Do not invert the positions of the two bottles.
Replace the cover when finished.
Moreover, after refilling the Wash/System Liquid, leave it to
settle for at least 6 hours.
NOTE:
Distilled water to be used in the Liaison instrument has to be
defined according to CLSI guidelines for laboratory water
(Instrument Feed Water type: conductivity < 5 S/cm;
resistivity > 0.2 M/cm)
10.1. Daily maintenance

10.1.1.1. Empty the waste tank and preferably add 200 mL of commercial
hypochlorite or bleach.
10.1.2. Check liquid levels

10.1.2.1. Check Starter levels and replace them if not sufficient (see 4.3.2).
10.1.2.2. Check Wash/System Liquid level and replace the tanks if not sufficient
(the solution should be prepared at least 6 hours prior to use) - (see
4.3.1).
10.1.3. Save data (see 4.8)
63
10.2. Weekly maintenance
10.2.1. Switch off the system (see 4.2.1)

10.2.2.1. Clean instrument worktops with a cloth damped with an
alcoholic/disinfectant solution.
10.2.2.2. Clean the exterior parts of the two needles with a cloth damped with
water, taking great care not to bend the needles.
10.2.3. Switch on the system (see 4.1.1)

10.2.4.1. Check Starter levels and replace them if not sufficient (see 4.3.2).
10.2.4.2. Check Wash/System Liquid level and replace the tanks if not sufficient
(the solution should be prepared at least 6 hours prior to use) - (see
4.3.1).
10.2.5. Check pipettor needles reference positions (see 4.10)

10.2.7.1. Click on the rectangle to the lower left:
64
10.2.7.2. The following window appears:
10.2.7.3. Select
10.2.7.4. The selection window appears as below:
select All as shown, and confirm with
and again with
10.2.8. CLEAN Tool

Use once CLEAN Tool (part of LIAISON Cleaning Kit)
Attention!
Some LIAISON kits may require to perform CLEAN Tool more
frequently, as specified into related instructions for use.
65
10.3. Monthly maintenance
10.3.1. Switch off the instrument (see 4.2.1)

10.3.2. Check the functionality of the Differential Switch
10.3.2.1. Press the TEST button
10.3.2.2. Expected behaviour: the Differential Switch should switch off
automatically.
Attention!
In case the behaviour differs from the expected, contact technical
assistance!
Note
The Differential Switch functionality must be performed only with
instrument and PC switched off.
Note
The Differential Switch could be either external to the instrument as a
separate box or installed on the UPS.
For any doubt, contact technical assistance.
10.3.2.3. After the test has been completed successfully, it is necessary to lift
the switch back to the ON position.

10.3.3.1. Clean instrument worktops with a cloth damped with an
alcoholic/disinfectant solution.
10.3.3.2. Clean the exterior parts of the two needles with a cloth damped with
alcohol, taking great care not to bend the needles.
10.3.3.4. Clean the starter tray with a cloth damped of water.
10.3.4. Switch on the system (see 4.1.1)
66
10.3.5. Decontamination and fluidic cleaning

10.3.5.1. Replace the starters with two bottles of distilled water, preferably at
35 - 40C.
10.3.5.2. Replace the Wash/System Liquid tank with a container filled with 2
litres of chemical use hypochlorite solution with 0.5% active chlorine.
NOTE: Instruction to prepare 2 litres of solution:
1. Fill a canister with 1.8 litres of distilled water
2. Add 200 ml of a household common bleach with a 3%-7% content of active hypochlorite
3. Place the proper cap and briskly mix the container
4. Example: in case of 5%-9% solution of active chlorine. It must be diluted 1:14 with distilled water
(about 140 mL with 1.86 L)
NOTE: Instruction to prepare 1 litre of solution:
1. Fill a canister with 0.9 litres of distilled water
2. Add 100 ml of a household common bleach with a 3%-7% content of active hypochlorite
3. Place the proper cap and briskly mix the container
4. Example: in case of 5%-9% solution of active chlorine. It must be diluted 1:14 with distilled water
(about 70 mL with 0.93 L)
10.3.5.3. Apply the rinsing procedure for Wash / System Liquid tank (see
10.3.9)
10.3.5.4. Carry out a System Test selecting the values at least equal to the
Section
Type
Cycles
Pipettor
Washer
Chamber Set A
BGW
LC - le
LC - ri
Reaction modules
Values
10
10
10
0
0
0
10.3.5.5. Replace the hypochlorite solution tank with another containing

distilled water.
10.3.5.6. Replace the two starter reagent containers filled with distilled water
with the two LIAISON PUMP Solution containers supplied with the
LIAISON Cleaning Kit.
67
Section
Type
Cycles
Pipettor
Washer
Chamber Set A
BGW
LC - le
LC - ri
Reaction modules
Values
10
10
10
0
0
0
10.3.5.8. After 10, replace the two starter reagent containers with the
LIAISON PUMP Solution with two starter reagent containers supplied
with distilled water (close the two LIAISON PUMP Solution
containers, keeping them at a temperature of 15-30C).
Section
Type
Cycles
Pipettor
Washer
Chamber Set A
BGW
LC - le
LC - ri
Reaction modules
Values
10
10
10
0
0
0
10.3.5.10.Replace the water bottles with two bottles of Starters (see 4.3.2).
10.3.5.11.Replace the tank containing distilled water with a tank of
Wash/System Liquid suitably diluted and prepared at least 6 hours
prior to use (see 4.3.1).
10.3.5.12.Launch the System Test at least twice with the values given in the
following table (see chap. 6):
Section
Type
Cycles
Pipettor
Washer
Chamber Set A
Values
1st run
10
10
10
68
Reaction modules
BGW
LC - le
LC - ri
0
0
0

10.3.6.1. Check the level of Starters and if necessary replace them if not
sufficient (see 4.3.2).
10.3.6.2. Check the Wash/System Liquid level and if necessary top up with a
solution prepared at least 6 hours prior to use (see 4.3.1).
10.3.7. Check pipettor needles reference positions (see 4.10)

10.3.9.1. Click on the rectangle to the lower left:
10.3.9.2. The following window appears:
10.3.9.3. Select
69
The selection window appears as below:
select All as shown, and confirm with
and again with
10.3.10.Wash / System Liquid container cleaning procedure

NOTE: Apply the rinsing procedure to each canister (single, primary, secondary)
10.3.10.1.Prepare 1 liter solution of 0.5% active Hypochlorite (see 10.3.4)
10.3.10.2.Discard residual liquid before cleaning the canister
10.3.10.3.Fill detergent into the canister
10.3.10.4.Close the canister
10.3.10.5.Wave the canister to and fro, avoiding spilling from rear holes of
tanks
10.3.10.6.Empty carefully the canister and rinse it thoroughly with distilled
water (to ensure an adequate rinsing, it is recommended to fill the tank at
least at half volume)
10.3.10.7.Repeat the previously operation at least two times more
70
Appendix to the
Quick Guide
According to Software Version 2.30
200/008-618,A-10/2010
Contents
APP.A: Special functions
A.1. STAT
A.2. Dilution
A.3. Autodilution
A.4. Autoreflex
Pag. 3
Pag. 3
Pag. 3
Pag. 4
Pag. 7
APP.B: Importing and updating an Assay File

B.1. Importing from mini CD
B.2. Importing from floppy disk
Pag. 9
Pag. 9
Pag. 11
APP.C: Quality control

C.1. Control management
C.2. Definition of new controls
C.3. QC status icon
Pag. 15
Pag. 15
Pag. 16
Pag. 18
APP.D: On-Line communication

D.1. Test acquisition: Query-All mode
D.2. Test acquisition: Host-Query mode
D.3. Result transmission: Valid mode
D.4. Result transmission: Not valid mode
Pag. 19
Pag. 19
Pag. 20
Pag. 20
Pag. 21
APP.E: Typing Integral data

E.1. Use
E.2. Procedure
Pag. 23
Pag. 23
Pag. 23
APP.F: Flags (in order of priority)
Pag. 25
APP.G: Annexes
Pag. 27
A.
Special functions
A.1. STAT
A.1.1. When loading a rack in the Sample Area (see 4.7), select the samples
concerned and press
Pressing
: the selected samples are shown in red.
again, the sample loses the assigned STAT priority.
A.1.2. Attention!
This function may cancel any calibration in progress.
A.2. Dilution
A.2.1. When a rack is present in the Sample Area (see 4.7), assign the tests to the
samples and then press
.
showing the assigned tests and selected sample.

A.2.2. Select the sample to dilute.
A.2.3. Select the test and then the dilution for the selected sample (the CA19-9
test in the figure). The test LED turns green.
A.2.4. The possible dilutions for the selected test are displayed to the left. Select
the desired dilution (in the figure the chosen factor is 1:100).
A.2.5. The
icon has the following two states:
: both the diluted and undiluted tests are programmed;
: only the diluted test is programmed.
A.2.6. Confirm with
A.2.7. The preceding steps can be repeated for all sample groups and for all the
tests required.
A.3. Autodilution
Attention!
Before using this function, remove all related integrals.
A.3.1. From the main menu select
A.3.2. From the left window:
select
A.3.3. From the window:
select the desired test (CA125 in the figure) and press
select
A.3.5. The following window appears:
in which the correct values for the example have already been entered.
In general:
Threshold concentration: enter the desired threshold
value;
1st Dilution Step: enter the Sample
volume (serum volume) and Buffer volume (diluent volume)
values in suitable proportions to obtain the desired Dilution
Factor;
2nd Dilution Step: if the values entered in the 1st
Dilution Step are insufficient for achieving the desired dilution,
enter the Vol. from 1st step (obtained from 1st Dilution Step)
and Buffer volume values in suitable proportions for achieving the
desired Dilution Factor;
Dilution Factor: this is the dilution factor obtained by
combining the 1st Dilution Step, with that obtained by the 2nd
Dilution Step if applied.
A.3.6. Confirm all requests with
until returning to the main menu.
A.3.7. Attention!
A.4. Autoreflex
Attention!
Before using this function, remove all related integrals.
A.4.1. Carry out steps A.3.1 to A.3.3 selecting the test (Rub-M in the example).
select
A.4.3. The following window appears:
select the desired test (Rub-Mc in the figure) and press

.
Attention!
It is not possible to select as reflex test the current test (Rub-M in
the described example).
A.4.4. Enter the reflex range values in the Reflex range 1 field.
The units of measure are indicated in the Unit: field.
A.4.5. If it is necessary to automatically foresee a second test launch in addition to
and carry out step A.4.3 again for
the one already selected, select
this test, then enter the reflex range value in the Reflex range 2 field.
A.4.6. Confirm all requests with
, until returning to the main menu.
A.4.7. Attention!
B.
Importing and updating an Assay File

B.1. Importing from mini CD
B.1.1. Check on board for the absence of integrals to the type of test for the Assay
File to import.
B.1.2. Highlight the tests list, carrying out steps A.3.1 and A.3.2.
B.1.3. Insert the mini CD into the disk reader, as shown in the following figure:
B.1.4. From the window:
select
B.1.5. The following window appears:
B.1.6. The name of one or more tests appear: highlight the first one and confirm
with
B.1.7. If the window below appears:
check that the indicated file name is correct, and if so confirm with
, otherwise select
and start again from point B.1.4.
B.1.8. The following message appears:
10
confirm by pressing
twice, until returning to the main menu.
B.1.9. Repeat steps B.1.4 to B.1.8 for all the assays contained in the mini CD.
B.1.10.
Remove the mini CD.
B.1.11.
Exit the program and switch off the PC (see 4.2.1).
B.1.12.
Switch on the PC and launch the program again (see 4.1.1).
B.2. Importing from floppy disk

B.2.1. Check on board for the absence of integrals to the type of test for the Assay
File to import.
B.2.2. Highlight the test list, carrying out steps A.3.1 and A.3.2.
B.2.3. Insert the floppy disk into the disk reader.
B.2.4. From the window:
11
select
B.2.5. From the following window:
click on
, select "A:\" as follows:
B.2.6. Select the required file (in the example, aTPO_A) and confirm with
.
B.2.7. If the window below appears:
12
check that the indicated file name is correct, and if so confirm with
otherwise select
and start again from point B.2.4.
B.2.8. The following message appears:
confirm by pressing
twice, until returning to the main menu.
B.2.9. Repeat steps B.2.4 to B.2.8 for all the necessary assays.
B.2.10.
Remove the floppy disk.
B.2.11.
Exit the program and switch off the PC (see 4.2.1).
B.2.12.
Switch on the PC and launch the program again (see 4.1.1).
13
14
C.
Quality control
C.1. Control management

C.1.1. The main differences between precision controls and accuracy controls are
as follows:
Precision
Accuracy
Frequency
Every session
Pre-period
Yes
No
Determined during
the pre-period
Determined by control
supplier
Range
C.1.2. Carry out the controls (see chap. 8).

C.1.3. If the control is not recognised by the system, the following message is
displayed:
in the illustrated example, control 12345 is not on the list (in the LotNo. field) and should therefore be added to the list (see C.2 starting from
step C.2.3).
15
C.2. Definition of new controls
C.2.1. From the main menu, press

the left:
C.2.2. Press
C.2.3. Press the
; the following window appears to
; the following selection window appears:
icon; the following window appears:
16
C.2.4. Fill-in the fields in the Control Specification section as follows:

Name:
control name (up to 15 characters)
Lot-No.
lot number (up to 14 characters)
Expiry Date:
expiry date
Barcode-ID:
bar-code number (preceded by the symbol # )
C.2.5. Select the test involved by the control in the Assay Selection section.
C.2.6. Press the
C.2.7. Fill-in the fields in

Replications:
Range:
Target CV [%]:
Ref. Range:
icon; the following window appears:
the Control Data section as follows:

number of replications
acceptability interval (lower and upper range)
maximum value for the CV% (only for precision controls)
reference intervals (only for precision controls)
Also select accuracy control (Accuracy control) or precision control

(Precision control).
17
C.2.8. Confirm with
C.2.9. The window thus appears, for example, as below:
C.2.10. If controls are to be assigned to other tests, return to point C.2.5.
C.2.11. Confirm with
until returning to the main menu.
C.3. QC status icon

The last icon to the lower right of the screen shows if controls have been
performed on the system.
: All controls performed lie in the correct range or have been

displayed
: It is necessary to display the controls performed on the menu,

because one or more controls are outside of the predicted range.
This is accomplished from the main menu by pressing
18
D. On-Line Communication
If the system is part of an intranet that allows for On-Line work, certain of its
characteristics differ as explained below.
Attention!
Each test to be managed by host must be properly set.
D.1. Test acquisition: Query - All mode

D.1.1. From the Daily Lab Journal menu (see 9.1), press
opens the window below:
D.1.2. At the end of the transmission, confirm with
; this
D.1.3. At this point the system has acquired the samples to process from the
central system, along with the corresponding tests, which are inserted
into the Daily Lab Journal menu with to do status.
D.1.4. It is now possible to proceed with the normal integral and patient rack
loading: when a programmed patient is recognised in the Patient Area, it
assumes placed status in the Daily Lab Journal menu and will be
processed as soon as the
key is pressed.
19
D.2. Test acquisition: Host-Query mode

D.2.1. Insert a rack with patient samples in the Sample Area.
D.2.2. The system automatically requests from the central system the list of
tests requested for the samples present in the Sample Area, which are
inserted in the Daily Lab Journal menu with placed status and will
be processed as soon as the
key is pressed.
D.2.3. It is in any case possible to request the work list from the central system
(see D.1).
D.3. Result transmission: valid mode
D.3.1. From the Valid menu (see 9.2), press
; this opens the window:
in which it is possible to select the following fields:

Tagged
All
All Samples
From..To
D.3.2. Confirm with
if the desired samples have been selected (with

F7 )
to work on all samples
to work on all patient and control samples
not enabled
: transmission begins.
20
D.3.3. At the end of the transmission, confirm with
D.3.4. At this point the system has delivered the validated sample and
corresponding results to the central system.
D.4. Result transmission: not valid mode

D.4.1. In this mode, selecting
the Valid menu is not present:
therefore there is no option to validate the results on the LIAISON

system; this operation can only be carried out on the central system.
D.4.2. The Daily Lab Journal has two Online icons:
21
D.4.3. The system automatically sees to transmitting all results for validation to
the central system.
This operation is carried out once a certain number of ready for
transmission samples has been reached (this number is usually 6).
D.4.4. It is in any case possible to transmit any results not already transmitted to
the central system, before the system does so automatically:
press
(right icon) and carry out steps D.3.1 to D.3.4.
D.4.5. Attention!
Only the
icon, located to the lower right, permits
transmission of result for validation.
Instead, the
icon located to the lower centre, concerns acquisition
of work lists (see D.1-D.2).
22
E.
Typing Integral data

E.1.
Use
This procedure allows the system to recognize a specific Integral when the
barcode is not readable.
E.2.
Procedure
E.2.1. Insert the Integral onto the Reagent Area and press
following error message:
after the
E.2.2. Refer to annex Integral barcode data into Reagent Area for necessary
information, and take notes on a sheet.
E.2.3. Check that the field Article-No.: is selected.
E.2.4. Type the required value:
E.2.5. Press TAB or ENTER and type it again. The first entry is blind. As soon as the
system verifies that the same value has been entered twice, a green box
surrounds the field:
E.2.6. Press TAB or ENTER to reach the next field. Repeat the previous steps for all
the required fields.
E.2.7. In the field "Integral Layout", the value to be typed is 07 except for the
integrals B2MU, B2MS and "Cort", for which the value is 08.
23
E.2.8. Complete the fields Calibrators and Tolerances% with the values
available on the mini CD of the kit (see B.1): insert the mini CD and click on
into Reagent Area dialog.
If the mini CD is not available, contact the DiaSorin Customer Care.
E.2.9. When all the required fields have been inserted and TAB or ENTER has been
pressed, the integral should be recognized.
E.2.10.
If a message like the following appears:
, verify correctness of data, use mouse or Touch Screen

press
monitor to select the field to change and repeat steps E.2.3 to E.2.9.
24
F.
FLAGS (in order of priority)
Flag
<Q/>Q
11
(invalid
RLU) !
?
12
&
13
>/<
>>/<<
overdiluted
invalid
combi
partner
10
Description
Reagent aspiration skipped, because integral was removed before use
Mechanical error, e.g., pipetting error or measurement errors.
Within the "Daily Lab Journal", clicking on the button <Edit>
opens the [Detailed Sample Result] dialog box, where detailed
information about the result can be viewed.
Validity of Integral used for results has expired
The calculation of the measuring result is based on a calibration curve
whose validity has been exceeded or no calibration was performed
An incubation temperature is outside the limit for longer than 2
minutes
An incubation time deviation is more than +/- 2 minutes. The result
will be flagged if the time, when the RLU is reported from the
instrument, differs from the expected result time by more than 2
minutes.
The Reaction Module has received magnetic particles while the
magnetic particles shaker rotation speed was out of range
The control falls outside the range limit (for control results only)
Control of an Assay falls outside the range limit (for patient results
only)
The measured RLU is outside the specified signal range
Result of a combi-assay falls outside the normal range
Result of a measurement falls in a reflex zone
Result of a measurement falls outside the normal range (only for
patient tests).
Measurement result falls outside the measurement range
RLU values lower than those of the 1st point of the master curve
different from the zero point
Results of a CombiPartner or both are not valid
Appears alongside another flag; indicates presence of other errors.
Within the "Daily Lab Journal", pressing <Edit> opens the
[Detailed Sample Result] window with detailed information.
25
26
G. ANNEXES
1. System daily usage procedure
2. LIAISON User Maintenance Report

3. Symbols associated with integrals
4. Installed system features
5. System Test
6. Flags
7. Instrument diagram
8. Integral barcode data into Reagent Area
27
200/008-618,A-10/2010-Quick Guide LIAISON SW2.30_Annex 1
SYSTEM DAILY USAGE PROCEDURE 1/2
(with references to the Quick Guide)

LIAISON may only be used by authorised personnel.
In the event of problems or doubts about using the instrument,
contact the Technical Assistance Service.
1. If the 3 or more days of stop procedure has been carried out on the system,
follow the procedure listed at point 4.1.2.
2. With the system on, switch on the monitor and load the necessary integrals into the
Reagent Area (see chap. 7). They must shake for at least 30 before any use.
3. Carry out an instrument check (see chap. 5):

4. Carry out a System Test and check the results obtained (see chap. 6):
5. After the integrals have been shaking into the Reagent Area for at least 30,
calibrate them if necessary (see chap. 7):
30
minutes
SYSTEM DAILY USAGE PROCEDURE 2/2
(with references to the Quick Guide)

6. Run tests (see chap. 8),
validate and print the results (see chap. 9).
F7
7. Repeat steps 5 and 6 as necessary until the end of the work session.
8. Upon finishing the session, check the LIAISON user maintenance report form
(annexed) and, if necessary, carry out monthly or weekly maintenance, otherwise
carry out daily maintenance (see chap. 10); fill in the form. Monthly maintenance
already includes both weekly and daily maintenance procedures, which are thereby
automatically carried out. Weekly maintenance also includes all daily maintenance
procedures.*
9. For short periods of inactivity (for example, overnight and weekends) switch
off the monitor, keeping PC and instrument on.
For periods of inactivity of 3 days or more, follow the procedure shown in
4.2.2. This procedure is recommended also for periods of inactivity of minor length
(for example, weekends).
10. Prepare the Wash/System Liquid for the next session (see 4.3.1).
*Note: maintenance can be carried out at any time between two work sessions. It is
recommended to carry out maintenance either in the morning or evening, to avoid
interrupting daily work sessions. Failure to carry out maintenance or incorrect
maintenance procedures will jeopardise test results and cause interruptions
in daily sessions to allow for extra maintenance interventions.
MAINTENANCE OPERATIONS.
Month:___________ Year:___________
Action / Maintenance type

System switching off
Differential Switch testing
Instrument cleaning
Empty waste tank
System switching on
Decontamination and fluidic cleaning
Pump tool
Check of liquid levels
Check of pipettor needles reference position
Save Data
Depletion of message box
Clean Tool
Wash/System Liquid tank cleaning procedure
Daily
(4 operations)
Weekly
(9 operations)

Monthly
(11 operations)

Check the cell referred to the day when the procedure is performed
Activity performed
Daily maintenance
Weekly maintenance
Monthly maintenance
Signature:____________________
10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31
SYMBOLS ASSOCIATED WITH INTEGRALS

Lane occupied
Not operative
May be removed
Operativeness
Operative
Do not remove
Name of test
Remaining
determinations
Absent and not launched
Absent but already launched
Calibration
status
Performed but not validated

OK - validated
Present but relaunched
Performed but not validated
(previous calibration present)
INSTALLED SYSTEM FEATURES

Attention!
Check that this description is promptly updated
after each system update.
LIAISON INSTRUMENT Nr
Software:
Windows
LIAISON
QC
Method catalogue
Barcode reader EPROM
Version:
Firmware:
COP
WMP
PIP
Diluters
Version:
Hardware:
Pipettors (old/new)
Barcode reader (normal/modified)
Nichols line (enabled/disabled)
System state ID
Description:
On-line Communication:
Test acquisition (Query-All/Host-Query)
Result transmission (valid/not valid)
Technician:
Type:
Date:
SYSTEM TEST
Minimum cycle number
Cycles
Pipettor Washer
Normal
Before 3 or more days of non-activity
After 3 or more days of non-activity:
- run 1
- run 2
Replace Starters
Monthly maintenance:
- H20 Hypochlorite
- PUMP Solution H20
- H20 H20
- Starters System Liq. run 1
- Starters System Liq. run 2
Reactionmodules
Chamber
BGW LC - le LC - ri
Set A
3
1
1
1
10
0
0
0
3
10
3
10
10
10
3
10
10
3
10
10
10
0
1
1
0
1
1
0
1
1
10
10
10
10
10
10
10
10
10
10
10
10
10
10
10
0
0
0
0
3
0
0
0
0
3
0
0
0
0
3
Specifications
BGW:
120 < RLU < 320
CV% < 8
LC :
120000 < RLU < 180000
CV% < 2.5
If the average of LC-le e LC-ri is
then their difference must not

exceed
greater than
and less than
120000
130000
6000
130000
140000
6500
140000
150000
7000
150000
160000
7500
160000
170000
8000
170000
180000
8500
FLAGS (in order of priority)

N
Flag
<Q/>Q
11
(invalid
RLU) !
?
12
&
13
>/<
>>/<<
overdiluted
invalid
combi
partner
10
Description
Reagent aspiration skipped, because integral was removed before use
Mechanical error, e.g., pipetting error or measurement errors.
Within the "Daily Lab Journal", clicking on the button <Edit>
opens the [Detailed Sample Result] dialog box, where detailed
information about the result can be viewed.
Validity of Integral used for results has expired
The calculation of the measuring result is based on a calibration curve
whose validity has been exceeded or no calibration was performed
An incubation temperature is outside the limit for longer than 2
minutes
An incubation time deviation is more than +/- 2 minutes. The result
will be flagged if the time, when the RLU is reported from the
instrument, differs from the expected result time by more than 2
minutes.
The Reaction Module has received magnetic particles while the
magnetic particles shaker rotation speed was out of range
The control falls outside the range limit (for control results only)
Control of an Assay falls outside the range limit (for patient results
only)
The measured RLU is outside the specified signal range
Result of a combi-assay falls outside the normal range
Result of a measurement falls in a reflex zone
Result of a measurement falls outside the normal range (only for
patient tests).
Measurement result falls outside the measurement range
RLU values lower than those of the 1st point of the master curve
different from the zero point
Results of a CombiPartner or both are not valid
Appears alongside another flag; indicates presence of other errors.
Within the "Daily Lab Journal", pressing <Edit> opens the
[Detailed Sample Result] window with detailed information.
INSTRUMENT DIAGRAM
Legend
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
14.
15.
16.
17.
Pipettors (left & right)

Cuvette loader
Stacker
Sample Area
Reagent Area
Incubator loader
Washer loader
Incubator
Washer transport
Washer lift
Diluters (left & right)
Back-transport
Pusher
Measure chamber
Barcode reader
Waste bag
Starter Area
Teacher
Integral barcode data into Reagent Area

EN LIAISON® QG 23 Reva

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Quick Guide

According to Software Version 2.30

DiaSorin Deutschland GmbH

This document is referred to the highest access level.

2. System daily usage procedure

3. Definitions & glossary

4.9. Electronic Instructions for Use

5. Checking instrument status

7. Using and calibrating a kit

10. Routine maintenance

10.2.7. Depletion of "Message box"

Pipettors (left & right)

(with consumables part numbers)

2. SYSTEM DAILY USAGE PROCEDURE

3. DEFINITIONS & GLOSSARY

Instrument: Part of LIAISON System that contains only the LIAISON

Prime: Start-up cycle for individual parts of instrument involved in fluidics,

Moves the reaction module back from pusher

Test to verify accuracy of the right dispensing

4.1. Switching on the system

Switch on PC, Monitor, and Printer.

The following window appears:

program pressing the icon

Then click the

icon and await initialisation, clearing and

During initialisation, it is possible that the following message appear:

it informs that the system is starting to shake the magnetic particles

Lastly, the main menu window appears:

3 or more days of stop

Substitute distilled H2O bottles with Starters bottles.

Substitute the tank of distilled H2O with a tank containing

If the system is off, switch on according to 4.1.1.

4.2. Switching off the system

From the main menu select

The following window appears :

From the window:

3 or more days of stop

4.3. Replenishing system consumables

The deionised water to be used for the dilution of the Wash/System

Prepare Wash/System Liquid pouring 9 L of distilled H20, then add a

bottle labelled as LIAISON Wash/System Liquid (1 L) taking care to

Leave the tank to settle for at least 6 hours without connecting it to

If a previously used tank is refilled, wait 6 hours anyway before using

Connect the tank to the instrument.

Run a System Test, selecting the values at least equal to the

Remove cover from Starter area.

Remove used bottles and replace them with fresh bottles, as

taking care to insert Starter LIAISON

Starter LIAISON 2 in position A2, respecting right connections (the

When this procedure is finished, replace the Starter area cover.

Run a System Test, selecting the values at least equal to the

In case it is necessary to check the level of remaining liquid into

The bottle shall not be reversed upside down

Bottle is kept in touch

The starter level capacitive LED shall remain on:

Starter Level LED

Use only DiaSorin approved Reaction Modules.

Insert Reaction Modules on the Stacker belts when not in motion,

start again loading Reaction Modules.

(see also 5.1.3).

that the covers have been removed from each vial;

that no foreign material or liquid is present on the vial membranes;

that the vials contain no bubbles.