Page 1 D09755_08 Insert IQ Kit – Dispensing

EN
IQ Kit – Dispensing TEST PROCEDURE
This dispensing qualification test is based on the database preinstalled in the
software. Follow the instructions to restore the database (DB). This database
981704 creates automatically calibrators, sample requests, and the complete test flow
with critical test limits.
5 × Saline N11229
1 × AY25A N11230 Materials required but not provided
• CLRW (Clinical Laboratory Reagent Water) grade water (aseptic and

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INTENDED USE free of heavy metals) and general laboratory equipment.
This kit is used for determination of dispensing performance of Thermo
Scientific™ Gallery™, Gallery Plus, Indiko™, and Indiko Plus analyzers. • Pipette for 1500 µl manual pipetting.
Note: Software version 4.0 or newer must be used if Gallery/Gallery Plus • 2 ml sample cups.
analyzer to be tested does not contain 420 nm filter. Otherwise software
version 3.0 or newer is required. Calibration
Note 2: Updated dispensing applications are included in software version 5.3 This test is based on the database preinstalled in the software. Follow the
or newer installation package. instructions.

SUMMARY Instructions for saving factory delivered database and restoring the IQ
The dispensing qualification test (later: test) is performed for the factory database
delivered analyzer as part of the Installation Qualification (IQ) procedure by
field engineer trained by Thermo Scientific. 1. Open the user interface and log in as Main user. Factory default
password is Main user.
PRINCIPLE OF THE PROCEDURE 2. Save the factory delivered database into the workstation hard disk
In this IQ test analyzer performs an end-point dispensing test containing four drive. This is performed by selecting F5 → 2 Actions. Select from
(4) dispensing actions. The dilution performance is determined from the below Save DB.
repeatability of the sample run and calibration triplicate precision. 3. Use the name suggested as default and mark it down.
Responses are measured using analyzer preinstalled filter (405 or 420 nm).
First, the test calibration is run with yellow AY25A solution with six (6) 4. Select Restore Default DB → Yes.
different dilution ratios performed automatically by the analyzer. Three (3) 5. If testing Gallery/Gallery Plus analyzer choose from the list
replicates are performed from each calibration point. This produces 6 × 3 = “ARC_XX_IQ_disp_Gallery.bak” or if testing Indiko/Indiko Plus
18 dilutions. analyzer choose “ARC_XX_IQ_disp_Indiko.bak” database → Open
Accuracy of the triplicates is detected by the error estimate limits set in the (XX = database version).
calibration parameters. If no warnings appear in the test calibration window, 6. Restart of the user interface will happen automatically.
sample can be run.
Automatic calibration dilutions are seen in Table 1 and Table 2. 7. Log-in as Main user.
8. If analyzer is equipped with ECM/ISE unit, disable ECM/ISE unit on
Dilution Calibrator Diluents Total volume in cuvette the user interface (F5 → 7 Configuration → Analyzer → Additional
1+3 44 µl 132 µl 176 µl module = None).
1+5 30 µl 150 µl 180 µl
1+10 16 µl 160 µl 176 µl Note: If filter configuration does not include one of the filters the following

encourage use of these products in any manner that might infringe the intellectual property rights of others.
1+20 10 µl 200 µl 210 µl message will appear: "Filter is missing (test DILTESTGAx, wavelength 4xx)".
1+40 6 µl 240 µl 246 µl This message can be ignored. Follow the test procedure and choose the
1+120 2 µl 240 µl 242 µl racks according to the instructions.
Table 1. Dilution ratios in calibration of Gallery/Gallery Plus.
Run Start-up
Dilution Calibrator Diluents Total volume in cuvette 1. Fill the fresh water canister with CLRW grade water and ensure that
1+1 46 µl 46 µl 92 µl the cuvette waste bin is empty. Perform extra wash by selecting F5 →
1+2 30 µl 60 µl 90 µl 2 Actions → Extra wash.
1+10 10 µl 100 µl 110 µl
2. Load cuvettes into the analyzer.
1+15 6 µl 90 µl 96 µl
1+30 4 µl 120 µl 124 µl 3. Run Start-up.
1+100 2 µl 200 µl 202 µl 4. Re-run if Start-up fails.
Table 2. Dilution ratios in calibration of Indiko/Indiko Plus. 5. When Start-up is accepted, the analyzer goes to Idle-state on the
main screen. During the Start-up tubing are primed, photometer is
SOLUTION INFORMATION calibrated, and water blank is measured using all filter wavelengths
Saline, code N11229 5 × 20 ml used in the analyzer.
AY25A, code N11230 1 × 20 ml
Note: Solution vials have two barcodes. Turn the long barcode on the right Inserting reagents, samples, and calibrators
side towards the reagent rack barcode reader.
Saline
Concentrations/Compositions 1. Remove caps from two Saline vials. See that there are no bubbles or
Saline: foam on top of the vials.
NaCl 0.9% 2. Insert both Saline vials into the reagent rack/disk. Face the right side,
Preservative 0.02% long barcode towards the position for barcode reading.
AY25A:
Dye <0.1% Inserting the calibrator
Preservative 0.02%
1. Take the AY25A solution and mix it by gently turning upside down.
Avoid air bubbles or foam formation. Do this gentle turning at least 10
Precautions times.
Exercise the normal precautions required for handling all laboratory
reagents/solutions. 2. Pipette 1500 µl of the AY25A solution into one 2 ml sample cup and
EUH208: Contains Isothiazolone compounds. May produce an allergic recap the vial immediately.
reaction 3. Depending on analyzer filter configuration (405 or 420 nm filter) place
the sample cup to the sample rack as guided in Picture 1 or Picture 2.
Preparation
Solutions are ready-to-use.
Note: Check that there are no bubbles on the surface of the solution when
you insert vials in the analyzer.

Storage and Stability

Solutions are stable at 2…25 °C until the expiry date printed on the label.
AY25A solution vial must be recapped immediately after use.
Page 2 D09755_08 Insert IQ Kit – Dispensing

Gallery/Gallery Plus analyzers with 420 nm filter and

Indiko/Indiko Plus analyzers
Rack Rack
Sample cup Solution Volume
number position
01 1 2 ml AY25A 1500 µl

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Position 4
Picture 4. Sample positioning.
3. Open analyzer sample rack cover and insert the rack.
4. When analyzer has recognized the sample rack, select Start to start
analyzing the sample.

Position 1 Finishing the test run

Picture 1. Calibrator positioning.
1. When the sample results appear in the main screen, click the results.
Gallery/Gallery Plus analyzers with 405 nm filter 2. Select all 30 sample results active and print the sample results (use
Rack Rack CutePDF Writer or a printer).
Sample cup Solution Volume
number position
03 3 2 ml AY25A 1500 µl
3. x
In order to calculate the mean value ( ), the standard deviation (SD)
and the relative standard deviation (RSD, CV%) of the results, select
Ctrl + Shift + S on the keyboard.
4. Stand-by is not needed.

Restoring the original database

Restore the original customer database by following the instruction below:
1. From the main window, select F5 → 2 Actions → Restore DB.
2. Choose the same database saved before → Open.
3. Wait until the user interface has been restarted automatically.
4. If analyzer is equipped with ECM/ISE unit, log in to user interface and
Position 3 enable the ECM/ISE unit.
Picture 2. Calibrator positioning.
ACCEPTANCE CRITERIA
Calibration No error messages
4. Open the sample rack cover from the analyzer and insert the rack.
Sample results All results between 22.5–27.5

encourage use of these products in any manner that might infringe the intellectual property rights of others.
5. When the analyzer has recognized the sample rack, select Start to Count of sample results 30
start the calibration. Repeatability of sample results CV% ≤ 3.0 %

Calibration acceptance RESULTS

1. When test calibration is ready (see from the main window, right side), Mark to the IQ document for successful dispensing quality test.
click the calibration and check the results. It is suggested that a paper format copy is produced and signed by the field
2. If no warnings appear, accept the calibration. engineer.
3. If you receive warnings, do not accept the calibration. Re-calibrate by
MANUFACTURER
pressing re-calibration key. Start the calibration.
Thermo Fisher Scientific Oy
4. Print the results with CutePDF Writer to the hard disk drive (e.g. into Analyzers & Automation
My Documents folder) or a printer if available. Clinical Diagnostics
Ratastie 2, P.O. Box 100, FI-01621 Vantaa, Finland
Run the sample Tel. +358 10 329 200
1. Pipette 1500 µl of the AY25A solution into one 2 ml sample cup and www.thermofisher.com/gallery
recap the vial immediately. www. thermofisher.com/galleryplus
www. thermofisher.com/indiko
2. Depending on the analyzer filter configuration place the sample cup to www. thermofisher.com/indikoplus
the sample rack as guided in Picture 3 or Picture 4. E-mail: [email protected]

Gallery/Gallery Plus analyzers with 420 nm filter and Date of revision (yyyy-mm-dd)
Indiko/Indiko Plus analyzers 2016-06-02
Rack Rack
Sample cup Solution Volume
number position Changes from previous version
02 2 2 ml AY25A 1500 µl Precautions: EUH208 added.

Position 2
Picture 3. Sample positioning.

Gallery/Gallery Plus analyzers with 405 nm filter

Rack Rack
Sample cup Solution Volume
number position
04 4 2 ml AY25A 1500 µl