Principle:

HumaCLIA 150 is an automated random-access chemiluminescent immunoassay (CLIA) IVD instrument for
quantitative, semi-quantitative and qualitative determination of levels or activity of various parameters such as
CA-125, FT3, FT4, T3, T4, TSH and PSA in human serum or plasma. In combination with HUMAN’S CLIA
reagents, it may be used as aid to diagnosis, for screening or monitoring of a range of medical conditions,
depending on the used reagent. HumaCLIA 150 is a closed system and can be used with predefined HUMAN
CLIA reagents only. For laboratory professional use only.
Specimen for analysis: SERUM or PLASMA
Specimen storage: 2-8°C ≤6 days
Chapters:
1. START UP
2. DAILY MAINTENANCE
2.1 CLEANING THE NEEDLE
2.2 MAGNET SEPARATION UNIT CLEANING
3. SHUTTING DOWN THE INSTRUMENT
4. LOAD CONSUMABLES
4.1 LOAD WASH BUFFERS
4.2 LOAD REACTION VESSELS
4.3 LOAD PRE-TRIGGER
4.4 LOAD TRIGGER
5. LOAD REAGENTS
6. PERFORM CALIBRATION
7. PERFORM QUALITY CONTROL
8. RUN SAMPLES
9. LED INDICATOR OF THE SAMPLE LOADER
10. USER MAINTAINANCE
Expected Values:

CA-125 <35 U/ml

FT3 1.71-3.71 pg/ml
FT4 0.7-1.48 ng/dl
T3 0.58-1.59 ng/ml
T4 4.87-11.72 ug/dl
TSH 0.35-4.94 uIU/ml
TOTAL PSA 0-4 ng/ml
 1. START UP

1. Check, if enough wash buffer is inside the external wash buffer tank. If not, refill it.
2. Empty liquid waste container.
3. Empty solid waste.
4. Check, if enough vessels are inside the vessel loading area. If not, refill them.
5. Open the lid of the instrument, open the reagent tray cover. Move the pipettor arm above the reagent tray.
6. Wipe the needle with wet tissue (distilled water).
7. Move the arm back above the pipettor wash station. Close the reagent tray cover, close the lid of the
instrument.
8. Switch on the PC. Wait until Windows is loaded completely.
9. Switch on the instrument. Start the software.
10. Wait until the software asks for initialization. Press Yes.
11. Wait until initialization is finished (5 min).
12. Login with user name admin and password admin, press Login.

2. DAILY MAINTENANCE

2.1 Cleaning the needle

If you already cleaned the needle when the instrument was switched OFF, follow step la to 1d.
1a. Navigate to Overview.
1b. Click on Preparation.
1c. Select Clean sample/ reagent probe and click on Perform.
1d. Follow the listed steps or - if you already cleaned the needle, click on OK.
1e. Click on OK. Switch on the instrument, wait 30 seconds, then click on INIT.
1f. Click on System Initialization and wait until Initialization is finished (5min).
1g. Quit the warning message "Analyzer lid is open" by clicking on the symbol, then click Close.

2.2 Magnet separation unit cleaning

2. Run Magnet Separation Unit Cleaning, follow step 2a. If it was done automatically by the scheduled auto
maintenance, skip it.

2a. Navigate to Utility, Maintenance and Maintenance Instructions.

Click on Magnet Separation Unit and wait until it is finished (10min).

3. SHUTTING DOWN THE INSTRUMENT

1. Be sure the instrument is in Stand-by status.

2. Click on the Power Button in the software.
3. Click on Close, proceed with OK.
4. Switch off the instrument.

4. LOAD CONSUMABLES

4.1 Load Wash Buffer

1. Navigate to Overview, click on Consumables.
2. Select the wash buffer and click on Unload. Jump to step 4, if no wash buffer is loaded.
3. Confirm with OK.
 4. Click on Load Wash buffer.
5. Select Manual Input and enter the lot number of the wash buffer manually.
6. Click Save.
7. Remove the remaining liquid from the external wash buffer tank and refill it with new prepared wash
buffer solution.

4.2 Load reaction vessels

1. Navigate to Overview, click on Consumables.
2. Select the reaction vessels and click on Unload. Jump to step 4, if no vessels are loaded.
3. Confirm with OK:
4. Click on Load Reaction Vessel.
5. Select Manual Input and enter the lot number of the vessels manually.
6. Click on Save.
7. Fill the vessels into vessel loader.

4.3 Load Pre-Trigger

1. Navigate to Overview, click on Reagent Load.
2. Click on the bottle of Pre-Trigger.
3. Click on Pre/ Trigger Unload. Jump to step 6, if no Pre-Trigger is loaded.
4. Confirm with OK. Click on the bottle of Pre-Trigger.
5. Remove the existing Pre-Trigger bottle from the instrument.
6. Put the new bottle into the instrument and connect it with the right cover tubing (brown colour).
7. Click on Pre/ Trigger Load.
8. Click into the empty field next to Barcode.
9. Scan the barcode of the Pre-Trigger bottle with the barcode scanner.
10. Click on Save.
11. Quit the warning message "Pre-Trigger solution insufficient (alarm release)" by clicking on the alarm
symbol.

4.4 Load Trigger

1. Navigate to Overview, click on Reagent Load.
2. Click on the bottle of Trigger.
3. Click on Pre/ Trigger Unload. Jump to step 6, if no Trigger is loaded.
4. Confirm with OK. Click on the bottle of Trigger.
5. Remove the existing Trigger bottle from the instrument.
6. Put the new bottle into the instrument and connect it with the right cover tubing (white colour).
7. Click on Pre/ Trigger Load.
8. Click into the empty field next to Barcode.
9. Scan the barcode of the Trigger bottle with the barcode scanner.
10. Click on Save.
11. Quit the warning message "Trigger solution insufficient (alarm release)" by clicking on the alarm
symbol.

5. LOAD REAGENTS

1. If you want to run a new reagent cartridge, proceed with step 2. If you want to run an already opened
reagent cartridge, jump to step 4.
2. Mix the reagent cartridge carefully by slowly inverting them. This needs to be done, until the magnetic
particles are completely in liquid. There must be no sediment particles at the bottom.
3. Remove the hard plastic covers of the reagent cartridge. Replace them with the flexible covers (soft
caps) from the kit, squeeze the soft caps to ensure they are open.
4. Be sure the instrument is in Stand-by status.
 5. Open the lid of the instrument, open the reagent tray cover. Put the reagent cartridge to a free position of
the tray.
6. Optional: Use the rotator button to rotate the reagent tray.
7. Close the reagent tray cover, then close the lid of the instrument.
8. Wait until instrument is finished with initial mixing (5 min).
9. Quit the warning message "Analyzer lid is open" by clicking on the alarm symbol.

6. PERFORM CALIBRATION

1. Bring the standards to room temperature.

2. If you want to calibrate a new reagent lot, proceed with step 3. If you want to calibrate an already existing
reagent lot, jump to step 10.
3. Navigate into Overview, click on Calibration.
4. Click on Calibrator Setting.
5. Click on Add.
6. Scan the QR code from the inside of the kit with the barcode scanner.
7. Click on OK.
8. Select Rack Mode. Define the rack ID and the rack positions for the standards.
9. Click on Save.
10. Put the standards onto the rack. Rack ID and positions must be the same like defined in the calibration
setting.
11. Insert the rack with the standards to a free position of the instrument. Close the sample loader.
12. Navigate to Overview and click inside the Reagent carousel.
13. Click on the reagent cartridge you want to calibrate.
14. Click on Calib. Order.
15. Click the Run button of the instrument.*
16. Wait until calibration is finished.
17. Navigate to Overview and click on Calibration.
18. Click on View Calib. Status.
19. Check, if the calibration was successful. Click on Detail for more information about the calibration.
20. Click on the left area to show details on the right area.

7. PERFORM QUALITY CONTROL

1. Bring the quality controls to room temperature.

 If you want to run already aliquoted and frozen quality controls, thaw and keep them at RT for 30
minutes and then mix them shortly.
 If you want to run fresh quality controls, read the IFU of the controls for how toprepare them.

2. If you want to run a new QC lot, proceed with step 3. If you want to run an already existing QC lot, jump to
step 15.
1. Navigate to QC, click on Setting.
2. Click on Add.
3. Enter QC information of level 1.
4. Select Rack Mode. Define the rack ID and the rack position for the control level 1.
5. Select the tests and click on OK.
6. Click on the QC level in the list to display the parameter details on the right area.
7. Double click on the empty field in column target value and enter the target val-ues, which are listed on
the target value sheet. Do the same for the SD value.
8. Click on Save.
9. Click on QC rules.
10. Select the assigned tests and activate 1-3S for all tests and inactivate the other rules.
11. Click on OK, then click on Close.
12. Repeat step 4-13 for control level 2.
13. Put the controls onto the rack. Rack ID and corresponding positions must be the same like defined in the
QC setting.
14. Place the rack with the controls on a free position in the sample loader.
15. Navigate to QC and click on Order.
16. Select the tests and control levels you want to run and click on Apply.
17. Select QC First and click on Save.
18. Click the Run button of the instrument.
19. Wait until QC is finished.
20. Navigate to QC and click on Results.
21. Check, if the controls are in range (1-3S) and if there is any flag listed.
22. Click on L-J-Chart.
23. Select the assay, choose the date and click on Search.
24. Click on a single point of the control for detailed result information.

8. RUN SAMPLES

1. Bring the patient samples to room temperature.

2. Navigate to Sample.
3. If you want to run samples without barcodes, proceed with step 4. If you want to run samples with
barcode, jump to step 9.
4. Enter the sample No. and define the rack ID and the rack position. Optional: Enter the sample barcode
number.
5. Select the assays you want to run for this sample number. Click on Save.
6. Repeat steps 4 and 5 for all samples you want to run or use the Batch function (see step 7 and 8).
7. If you want to enter many samples for the same assay(s), select the assay(s) and click on Batch.
8. Enter the Start Rack ID, Start Position and Sample Quantity. Click on Save. Jump to step 12.
9. Enter the sample No. and the sample barcode number.
10. Select the assays you want to run for this sample number. Click on Save.
11. Repeat steps 9 and 10 for all samples you want to run.
12. You can see all the entered samples with defined rack position and status in the list on the right area.
13. Click on a sample number in the list to show the ordered test.
14. To add a parameter, select a sample number and click on the parameter you want to add. Click on Save.
15. To enter specific patient data, select a sample number and click on Patient.
16. Enter patient data. Click on Save. Click on OK, then click on Close.
17. To change the number of replicates or to enter a manual dilution, select a sample number and click on
Options.
18. Enter number of replicates by double click in this field and/or enter manual dilution ratio. Click on Save.
19. To have a better overview of all ordered samples, click on List.
20. Check the list and put the racks onto the instrument. Attention: Put the samples on the correct rack IDs
and positions according to the order. Samples with barcode and without rack information can be put on
any free rack position.
21. Click on Close and then on the Run button of the instrument.
22. Wait until the sample run is finished.
23. Navigate to Results. Click on Current to show all sample results from today.
24. Click on a sample number in the left area to show the results in the right area.
25. Click on Details to show full traceability.
26. All sample results from yesterday and before are listed in History. Click on Search button.
27. Enter search criteria and click on OK.
 9. LED INDICATOR OF THE SAMPLE LOADER

Flashing and alternating orange:

Sample loader is moving. Do not touch inside the sample loader!

Constant green:
Rack is loaded and was not processed yet and can be removed.

Constant orange:
Rack is loaded and under processing inside the instrument and cannot be removed.
Do not insert another rack on this position!

Flashing green:
Samples of this rack were pipetted and this rack can be removed.

10. USER MAINTENANCE

10.1 Prime/Empty - on Demand

If instrument is OFF for more than 5 days
1. Navigate to Utility, Maintenance and Maintenance instructions. Click on Prime/Empty.
2. Select all 4 points (Sample/ Probe, A Solution, B Solution, MG Dispense). Click on Next.
3. Remove the bottles of Pre-Trigger and Trigger and replace them with bottles of distilled water.
4. Disconnect the tubing of the external wash buffer tank.
5. Disconnect the tubings of the inner wash buffer tank.
6. Remove the inner wash buffer tank and pour the wash buffer into the external wash buffer tank.
7. Fill the inner wash buffer tank with distilled water and connect the tubings back to the inner wash buffer
tank.
8. Make sure, the liquid waste tank is not full. Then click on Next.
9. Follow the display screen and proceed with 'Next' after each step. (Total time 21 min: 30 sec mechanical
reset, 3 min sample probe priming, 9 min Pre-Trig-ger / Trigger priming, 9 min magnetic separation unit
priming). After the last step, click on Close.
10. Click on Prime/ Empty again. Select all 4 points (Sample/Probe, A Solution, B Solution, MG Dispense).
Click on Next.
11. Remove the bottles of Pre-Trigger and Trigger and remove the distilled water.
12. Disconnect the tubings of the inner wash buffer tank and remove the distilled water from the inner wash
buffer tank.
13. Reconnect the tubings to the emptied inner wash buffer tank.
14. Make sure, the liquid waste tank is not full. Then click on Next.
15. Follow the display screen and proceed with Next after each step. After the last step, click on Close.
16. Close the software and switch off the instrument for more than 5 days. Empty the inner wash buffer tank
(it was filled partly because of remaining liquid in the tubings).
17. After more than 5 days turned off, connect the bottles of Pre-Trigger and Trigger.
18. Fill the inner wash buffer tank with wash buffer (from the external wash buffer tank) and place the inner
wash buffer tank on the instrument.
19. Screw the caps with sensors back on the inner wash buffer tank. Then screw the cap with sensor back on
the external wash buffer tank.
20. Before working on the instrument the next time, perform Prime/ Empty first the tubings must be
connected to the correct consumables: Pre-Trigger, Trig-ger, Wash Buffer) and perform Magnetic
Separation Unit Cleaning (see chapter 2.2).
10.2 Clean the sample loader and the instruments surfaces - on demand

1. Make sure, the instrument is in Stand-by mode.

2. Clean the sample loader with wet tissue (distilled water).
3. Clean the inner and the outer surface of the instrument with wet tissue (dis-tilled water).

10.3 Daily
See Chapter 2.
10.4 Weekly
1. Switch off the instrument. Unmount the reagent tray, clean the reagent carou-sel, using a dry tissue to
clean the condense water.
2. Mount back the reagent tray.
3. Switch on the instrument, wait 30 seconds, then initialize the instrument.
10.5 Two-Weekly
1. Navigate to Overview and click on Preparation. Make sure the instrument is in Stand-by mode.
2. Select Clean aspiration probe of washing system and click on Perform. Switch off the instrument.
3. Remove magnetic separation probe unit (aspiration assembly). Clean it with wet tissue (alcohol).
Reassemble afterwards. Then click on OK.
4. Select Clean exterior of sample probe and wash cup and click on Perform.
5. Follow the listed steps in the Software.
6. Close the reagent tray cover. Click on OK. Switch on and initialize the instrument.
10.6 Monthly
1. Navigate to Overview and click on Preparation. Make sure, the instrument is in Stand-by mode.
2. Select Clean Anti-dust screen and click on Perform. Switch off the instrument.
3. Remove the two dust filters from below the instrument.
4. Clean the filters with tap water, vacuum cleaner or brush. Let them dry naturally. After replacing the
filters, click on OK.