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: [email protected]

This document is referred to the highest access level. Working with lower level access may cause lack of some functionalities.

3

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. 13 4.1.2. 3 or more days of stop Pag. 15

4.2. Switching off the system Pag. 16 4.2.1. Normal Pag. 16 4.2.2. 3 or more days of stop Pag. 17

4.3. Replenishing system consumables Pag. 18 4.3.1. Wash/System Liquid Pag. 18 4.3.2. Starter Reagents Pag. 19 4.3.3. Reaction Modules Pag. 21 4.3.4. Waste tank Pag. 22 4.3.5. Waste bag Pag. 22

4.4. Integrals Pag. 23 4.4.1. New Integrals Pag. 23 4.4.2. Used Integrals not inserted Pag. 24 4.4.3. Used Integrals already inserted Pag. 24

4.5. Loading in Reagent Area Pag. 24 4.6. Samples Pag. 26

4.6.1. Rules for all sample types Pag. 26 4.6.2. Patient samples Pag. 27 4.6.3. Light Check Pag. 27 4.6.4. Controls Pag. 27 4.6.5. External calibrators (only for certain kits) Pag. 28

4.7. Loading in Sample Area Pag. 28 4.7.1. Opening Sample Area Pag. 28 4.7.2. Loading racks Pag. 28 4.7.3. Closing Sample Area Pag. 32 4.7.4. Error messages Pag. 32

4.8. Saving data Pag. 35 4.8.1. Use Pag. 35 4.8.2. Procedure Pag. 35

4

4.9. Electronic Instructions for Use Pag. 37 4.10. Centering pipettor needles Pag. 39

5. Checking instrument status Pag. 41

5.1. Consumables Pag. 41 5.1.1. Wash/System Liquid, Starter Reagents

and Reaction Modules Pag. 41 5.1.2. Temperatures and voltages Pag. 42 5.1.3. Waste tank – Waste bag Pag. 43

6. System Test Pag. 45

6.1. Loading racks Pag. 45 6.2. Selecting tests Pag. 45 6.3. Evaluating results Pag. 46

7. Using and calibrating a kit Pag. 49

7.1. Loading a kit Pag. 49 7.2. Checking calibration status Pag. 49 7.3. Calibration Pag. 50 7.4. Finishing use of a kit Pag. 53

8. Running tests Pag. 55 9. Managing results Pag. 59

9.1. Displaying results Pag. 59 9.2. Validating results Pag. 60 9.3. “Daily Lab – Journal” and “Valid menu” Pag. 60

10. Routine maintenance Pag. 63

10.1. Daily maintenance Pag. 63 10.1.1. Clean the instrument Pag. 63 10.1.2. Check system liquids Pag. 63 10.1.3. Save data Pag. 63

10.2. Weekly maintenance Pag. 64 10.2.1. Switch off the system Pag. 64 10.2.2. Clean the instrument Pag. 64 10.2.3. Switch on the system Pag. 64 10.2.4. Check system liquids Pag. 64 10.2.5. Center pipettor needles Pag. 64 10.2.6. Save data Pag. 64

5

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 10.3.3. Clean the instrument Pag. 66 10.3.4. Switch on the system Pag. 66 10.3.5. Decontamination and fluidic cleaning Pag. 67 10.3.6. Check system liquids Pag. 69 10.3.7. Center pipettor needles Pag. 69 10.3.8. Save data Pag. 69 10.3.9. Depletion of "Message box" Pag. 69 10.3.10. Wash / System Liquid container cleaning procedure

Pag. 69

7

1. Illustrations

Legend 1. Pipettors (left & right) 2. Cuvette loader 3. Stacker 4. Sample Area 5. Reagent Area 6. Incubator loader 7. Washer loader 8. Incubator 9. Washer transport 10. Washer lift 11. Diluters (left & right) 12. Back-transport 13. Pusher 14. Measure chamber 15. Barcode reader 16. Waste bag 17. Starter Area

Teacher

8

Legend (with consumables part numbers) 1. Light Check (319101) 2. Starter reagents (319102) 3. Wash/System liquid (319100) 4. Integrals 5. Reaction modules (319130) 6. Wash/System liquid tank 7. Waste tank 8. “A” rack 9. “C” rack 10. “L” rack 11. “P” rack 12. Waste bag (450003)

9

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.

11

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 instrument’s 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 Moves the reaction module back from pusher

to incubator for next incubation

Barcode Reader Assembly to read the barcode

BGW Test to check quality of instrument washing

Chamber Lift Dispensation head of starters

Chamber Transport Moves the reaction module inside into the measure chamber

Cleaning Kit A kit used for maintenance, made of:

• CLEAN Solution, to clean needles • PUMP Solution, to clean starter pumps

Cuvette Loader Two belts to transport reaction modules into the Stacker

CV% Statistical variable that shows dispersion rate of measurements

Geometric curve check Disqualification criterion for a calibration, based on a range in which a certain geometric figure must lie.

Incubator 16 – position assembly in which reaction modules are incubated

Incubator Loader Moves reaction modules from the first pipetting position to the incubator

Integral Reagent cartridge (made up of vials) to be inserted into the Reagent Area

LC-le Test to verify accuracy of the left dispensing pipettor, carried out by Light Check solution

12

LC-ri Test to verify accuracy of the right dispensing pipettor, carried out by Light Check solution

Light Check Control provided as lyophilised material

Measurement Chamber Reading area in which chemical reaction and measurements occur

Pipetting areas Dispensation area for samples and reagents

Pusher Transports reaction modules to back-transport or measure chamber

Rack (Patient Rack) Module to be filled with sample tubes (9 or 12 positions)

Reaction module Plastic module consisting of 6 cavities in which immunometric reaction can take place

Reagent Area Integral loading area

RLU Relative Light Unit (signal strength measurement unit)

Sample Area Sample lodging area

Signal Range RLU range in which results for a specific assay must lie

Stacker Magazine (7 levels) in which reaction modules are stored inside the instrument

Starter reagents (Starters) Reagents dispensed during the readings to generate chemiluminescente signal

Teacher Tool to check centering of pipettor needles

Temperature: Air Environment temperature

Temperature: Reagent Reagent Area cooling temperature

Vial Container for just one reagent; more vials form an integral

Wash Station Each of the two washing wells for pipettor needles

Wash/System Liquid Solution (to be diluted 1:10 in distilled H20) used to wash pipettor needles and reaction module cavities

Washer Lift Mobile washing head for reaction modules

Washer Loader Moves reaction modules from incubator to Washer Transport

Washer Transport Transports reaction modules underneath the Washer Lift, in one cavity per time steps

Waste bag Container for used reaction modules

13

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® program pressing the icon on desktop.

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 LED’s in Sample Area guides (not occupied by any racks) to change to green.

14

4.1.1.6. Then click the icon and await initialisation, clearing and priming.

4.1.1.7. 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.

15

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:

16

Section Type Values 1st run

Values 2nd run

Cycles Pipettor 10 10

Washer 10 10

Chamber Set A 10 10

Reaction modules BGW 0 1

LC - le 0 1

LC - ri 0 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 .

17

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 Pipettor 10

Washer 10

Chamber Set A 10

Reaction modules BGW 0

LC - le 0

LC – ri 0

4.2.2.5. The normal switching-off procedure can now be initiated (see 4.2.1).

18

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 µS/cm or > 0,2 MΩ). 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 Light–Check 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

following (see 6.2):

Section Type Values

Cycles Pipettor 10

Washer 10

Chamber Set A 3


LC - le 1

LC - ri 1

19

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.

20

4.3.2.6. Run a “System Test”, selecting the values at least equal to the following (see 6.2):

Section Type Values

Cycles Pipettor 3

Washer 3

Chamber Set A 10


LC - le 1

LC - ri 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 The bottle shall not be reversed upside down o The bottle shall not be shaken and has to be tilted only the essential o The bottle shall not loose contact with the walls of the starter tray:

Bottle is kept in touch with the starter tray

21

o The starter level capacitive LED shall remain 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:

Starter Level LED is ON

22

start again loading Reaction Modules.

4.3.3.4. 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.

4.3.4. Waste tank Empty the waste tank, and afterwards it’s 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).

23

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

1 2

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.

24

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 .

25

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.

26

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 use

B 15 mm (internal diameter)

W 14 mm (internal diameter)

E 13 mm (internal diameter)

F 12 mm (internal diameter)

I 11 mm (internal diameter)

A 10 mm (internal diameter)

J 9 mm (internal diameter)

K 8 mm (internal diameter)

N 7 mm (internal diameter)

Q 6 mm (internal diameter)

X -

Y -

Z -

C only for DiaSorin control special vials

L only for DiaSorin glass vials

(e.g. Light-Check)

P 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 µL plus the volume required to run the test.

4.6.1.4. Check for and remove air bubbles.

27

4.6.1.5. 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.

4.6.2. 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

28

“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

29

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:

30

Sample type Identification symbol

Identification color

Example

Patient with normal priority

1234

Patient with STAT priority

1234

Light Check $ $LC-$

External calibrator

$

$S100$A17.0

Control # #1234

4.7.2.5. 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. 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;

4.7.2.5.2. for Light Check:

• press the icon ;

• from the assay list on the right, select “LC-le”:

31


4.7.2.5.3. 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:


4.7.2.5.4. for controls:

• press ; the following window will appear:

32

• select the required control from the list and confirm by

pressing ; if the list doesn’t 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:

33

Reply with and check the position of each barcode.

4.7.4.2. 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.

34

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

35

4.8. Saving data 4.8.1. Use

4.8.1.1. This procedure saves current system status, and specifically:

• 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".

4.8.1.2. The procedure is used in two different situations:

• to save the work on a daily basis;

• to allow Technical Assistance to check system behaviour.

4.8.2. 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® Tools” folder on the desktop; its content will

appear, as shown:

36

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 Lab–Journal” (see 9.3).

37

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”)

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:

1

2

3

38

4.9.4. The Instructions for Use can be also printed (pressing ):

39

4.10. Centering pipettor needles

4.10.1. From the main menu select .

4.10.2. The following window appears :

select and then .

4.10.3. The following window appears:

40

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! It’s necessary to wear protective gloves to touch the needles.

4.10.7. Select and then and repeat previous step.

4.10.8. Confirm with .

41

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:

42

5.1.1.3. 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.

Consumable Color Available quantity

Wash/System Liquid

at least 2 L

less than 2 L

about 20’ of working time after turning yellow

Starter Reagents

at least (about) 50 mL

less than (about) 50 mL

about 20’ of working time after turning yellow

Reaction Modules at least 15

less than 15

43

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:

44

5.1.3.3. 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).

Waste Color Status

Waste tank

less than 8 L

between 8 L and 9 L

more than 9 L

Waste bag

less than 90 Reaction Modules

between 90 and 99 Reaction Modules

more than 99 Reaction Modules

45

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 is the number of primes of the two pipettor probes Washer is the number of primes of the washer head Chamber Set A is the number of primes of the DiaSorin starters BGW is the number of Background tests LC-le is the number of Lc-le tests Lc-ri is the number of Lc-ri tests

6.2.3. The minimum necessary values are given in the following table:

46

Cycles Reactionmodules

Pipettor Washer Chamber Set A BGW LC - le LC - ri

Normal 3 3 3 1 1 1

Before 3 or more days of non - activity 10 10 10 0 0 0

After 3 or more days of non - activity:

- run 1 10 10 10 0 0 0

- run 2 10 10 10 1 1 1

Replace Starters 3 3 10 1 1 1

Monthly maintenance:

- H20 – Hypochlorite 10 10 10 0 0 0

- PUMP Solution – H20 10 10 10 0 0 0

- H20 – H20 10 10 10 0 0 0

- Starters – System Liquid – run 1 10 10 10 0 0 0

- Starters – System Liquid – run 2 10 10 10 3 3 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. BGW: 120 < RLU < 320; CV% < 8 6.3.3. LC : 120000 < RLU < 180000; CV% < 2.5 6.3.4. 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).

47

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 greater than and less than

120000 130000 6000

130000 140000 6500

140000 150000 7000

150000 160000 7500

160000 170000 8000

170000 180000 8500

6.3.6. 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.

49

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:

50

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 in the “Reagent Integral Area” window to start integral calibration.

7.3.3. In case a refill action was occurred or the analyzer was idle for too long,

the following window appears:

51

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 is not pressed again, the calibration will not start!

52

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. The following window appears:

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:

53

• 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).

55

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

56

Note: enabled positions may be 9 instead of 12.

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 LED’s of the

selected buttons turn from red ( ) to green ( ).

8.4.6. Press to display the tests assigned to all the samples in the rack.

Press 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 from the main menu.

8.6. In case a refill action was occurred or the analyzer was idle for too long, the following window appears:

after pressing , the system will perform primes.

57

After the primes are completed, the following popup will appear:

After pressing , press again to start the programmed tests.

Attention:

If the button is not pressed again, the programmed tests will not start!.

8.7. 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.

59

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:

60

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 Lab–Journal” 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 Lab–Journal 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).

61

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. COMMUNICATE with the “central system” (see App. D);

9.3.3. From the “Daily Lab – Journal” menu it is also possible to:

9.3.3.1. VALIDATE a result (see 9.2).

9.3.4. To print, delete or validate one or more results, after pressing the corresponding icon, a window similar to the following appears:

62

where the following fields may be selected (where available): Tagged 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

confirm with and, if required, with .

63

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 µS/cm; resistivity > 0.2 MΩ/cm)

10.1. Daily maintenance 10.1.1. Clean the instrument

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)

64

10.2. Weekly maintenance

10.2.1. Switch off the system (see 4.2.1) 10.2.2. Clean the instrument

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.

10.2.2.3. Empty the waste tank and preferably add 200 mL of commercial hypochlorite or bleach.

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. Depletion of "Message box"

10.2.7.1. Click on the rectangle to the lower left:

65


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.

66

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. Clean the instrument

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.

10.3.3.3. Empty the waste tank and preferably add 200 mL of commercial hypochlorite or bleach.

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)

67

10.3.5. Decontamination and fluidic cleaning

10.3.5.1. Replace the starters with two bottles of distilled water, preferably at 35° - 40°C.

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 following (see 6.2):

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.

Section Type Values

Cycles Pipettor 10

Washer 10

Chamber Set A 10


LC - le 0

LC - ri 0

68


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°-30°C).


Section Type Values

Cycles Pipettor 10

Washer 10

Chamber Set A 10


LC - le 0

LC - ri 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 Values 1st run

Cycles Pipettor 10

Washer 10

Chamber Set A 10

Section Type Values

Cycles Pipettor 10

Washer 10

Chamber Set A 10


LC - le 0

LC - ri 0

69


LC - le 0

LC - ri 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. Depletion of "Message box"

10.3.9.1. Click on the rectangle to the lower left:


10.3.9.3. Select .

70

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

Appendix to the

Quick Guide

According to Software Version 2.30

200/008-618,A-10/2010

2

Contents APP.A: Special functions Pag. 3

A.1. STAT Pag. 3 A.2. Dilution Pag. 3 A.3. Autodilution Pag. 4 A.4. Autoreflex Pag. 7

APP.B: Importing and updating an Assay File Pag. 9

B.1. Importing from mini CD Pag. 9 B.2. Importing from floppy disk Pag. 11

APP.C: Quality control Pag. 15

C.1. Control management Pag. 15 C.2. Definition of new controls Pag. 16 C.3. QC status icon Pag. 18

APP.D: On-Line communication Pag. 19

D.1. Test acquisition: “Query-All” mode Pag. 19 D.2. Test acquisition: “Host-Query” mode Pag. 20 D.3. Result transmission: “Valid” mode Pag. 20 D.4. Result transmission: “Not valid” mode Pag. 21

APP.E: Typing Integral data Pag. 23

E.1. Use Pag. 23 E.2. Procedure Pag. 23

APP.F: Flags (in order of priority) Pag. 25 APP.G: Annexes Pag. 27

3

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 : the selected samples are shown in red.

Pressing 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 . The following window appears:

showing the assigned tests and selected sample. Note: enabled positions may be 9 instead of 12.

A.2.2. Select the sample to dilute.

4

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:

5

select .

A.3.3. From the window:

select the desired test (“CA125” in the figure) and press .


select .

6

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.


7

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:

8

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

the one already selected, select and carry out step A.4.3 again for 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.


9

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:

10

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:

11

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:

12

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:

13

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).

15

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

Range Determined during the pre-period

Determined by control supplier

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 “Lot-No.” field) and should therefore be added to the list (see C.2 starting from step C.2.3).

16

C.2. Definition of new controls

C.2.1. From the main menu, press ; the following window appears to the left:

C.2.2. Press ; the following selection window appears:

C.2.3. Press the icon; the following window appears:

17

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 icon; the following window appears:

C.2.7. Fill-in the fields in the “Control Data” section as follows: Replications: number of replications Range: acceptability interval (lower and upper range) Target CV [%]: maximum value for the CV% (only for precision controls) Ref. Range: reference intervals (only for precision controls) Also select accuracy control (“Accuracy control”) or precision control (“Precision control”).

18

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

19

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 ; this opens the window below:

D.1.2. At the end of the transmission, confirm with .

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.

20

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 if the desired samples have been selected (with

F7 )

All to work on all samples All Samples to work on all patient and control samples From..To not enabled

D.3.2. Confirm with : transmission begins.

21

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:

22

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).

23

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 after the following error message:

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”.

24

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:

press , verify correctness of data, use mouse or Touch Screen monitor to select the field to change and repeat steps E.2.3 to E.2.9.

25

F. FLAGS (in order of priority)

N° Flag Description

1 X Reagent aspiration skipped, because integral was removed before use

2 *

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.

3 E Validity of Integral used for results has expired

4 C The calculation of the measuring result is based on a calibration curve whose validity has been exceeded or no calibration was performed

5 T An incubation temperature is outside the limit for longer than 2 minutes

6 t

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.

7 A The Reaction Module has received magnetic particles while the magnetic particles shaker rotation speed was out of range

8 <Q/>Q The control falls outside the range limit (for control results only)

9 Q Control of an Assay falls outside the range limit (for patient results only)

10 (invalid RLU) !

The measured RLU is outside the specified signal range

11 ? Result of a combi-assay falls outside the normal range

12 & Result of a measurement falls in a “reflex zone”

13 >/< Result of a measurement falls outside the normal range (only for patient tests).

- >>/<< Measurement result falls outside the measurement range

- overdiluted RLU values lower than those of the 1st point of the master curve different from the “zero” point

- invalid combi partner

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.

27

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

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 Daily

(4 operations) Weekly

(9 operations) Monthly

(11 operations) 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

Check the cell referred to the day when the procedure is performed

Activity performed 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 Daily maintenance

Weekly maintenance Monthly maintenance

Signature:____________________

Lane occupied

Name of test

Remaining determinations

Operativeness

Not operative –May be removed

Operative –Do not remove

SYMBOLS ASSOCIATED WITH INTEGRALS

determinations

Calibration status

Absent and not launched

Absent but already launched

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: Version:

Windows

LIAISON®

QC

Method catalogue

Barcode reader EPROM

Firmware: Version:

COP

WMP

PIP

Diluters

Hardware: Description:

Pipettors (old/new)

Barcode reader (normal/modified)

Nichols line (enabled/disabled)

System state ID

On-line Communication: Type:

Test acquisition (Query-All/Host-Query)

Result transmission (valid/not valid)

Technician: Date:


SYSTEM TEST

Minimum cycle number Cycles Reactionmodules

Pipettor Washer

Chamber Set A

BGW LC - le LC - ri

Normal 3 3 3 1 1 1

Before 3 or more days of non-activity 10 10 10 0 0 0

After 3 or more days of non-activity:

- run 1 10 10 10 0 0 0

- run 2 10 10 10 1 1 1

Replace Starters 3 3 10 1 1 1

Monthly maintenance:

- H20 – Hypochlorite 10 10 10 0 0 0

- PUMP Solution – H20 10 10 10 0 0 0

- H20 – H20 10 10 10 0 0 0

- Starters – System Liq. – run 1 10 10 10 0 0 0

- Starters – System Liq. – run 2 10 10 10 3 3 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

200/008-618,A-10/2010-Quick Guide LIAISON®

SW2.30_Annex 6

FLAGS (in order of priority)

N° Flag Description

1 X Reagent aspiration skipped, because integral was removed before use

2 *

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.

3 E Validity of Integral used for results has expired

4 C The calculation of the measuring result is based on a calibration curve whose validity has been exceeded or no calibration was performed

5 T An incubation temperature is outside the limit for longer than 2 minutes

6 t

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.

7 A The Reaction Module has received magnetic particles while the magnetic particles shaker rotation speed was out of range

8 <Q/>Q The control falls outside the range limit (for control results only)

9 Q Control of an Assay falls outside the range limit (for patient results only)

10 (invalid RLU) !

The measured RLU is outside the specified signal range

11 ? Result of a combi-assay falls outside the normal range

12 & Result of a measurement falls in a “reflex zone”

13 >/< Result of a measurement falls outside the normal range (only for patient tests).

- >>/<< Measurement result falls outside the measurement range

- overdiluted RLU values lower than those of the 1st point of the master curve different from the “zero” point

- invalid combi partner

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. Pipettors (left & right) 2. Cuvette loader 3. Stacker 4. Sample Area 5. Reagent Area 6. Incubator loader 7. Washer loader 8. Incubator 9. Washer transport 10. Washer lift 11. Diluters (left & right) 12. Back-transport 13. Pusher 14. Measure chamber 15. Barcode reader 16. Waste bag 17. Starter Area

Teacher


Integral barcode data into Reagent Area

en_liaison®_qg_23_reva

Documents

system pag

instrument pag

data pag

results pag

use pag

kit pag

inserted pag

calibration pag