RUNNING STANDARDS

Standards’ calibration can be run either on command or automatically at pre-determined time intervals (refer to Chapter C, paragraph 1.5. Calibrations). Both choices can coexist. The commands are Immediate Standards and Timed Standards (Fig. 3).

Immediate Standards: Once the button is clicked a list of codes appears, select the desired tests and run by pressing Run. With Select All or Deselect All commands, it is possible to select or deselect the whole list. A message will ask the user whether the calibration standards are already present in the tray or not. If the samples are already present, click Yes and calibration procedure will automatically start. Otherwise, if calibration samples aren’t already placed on the tray, click No; in this case a procedure will guide the user through samples’ insertion. By clicking over sample’s position, the tray moves itself to accommodate cup’s insertion. Once the necessary cups have been inserted, it is possible to run the calibration.

Timed Standards: Only the codes with programmed times are enabled. After selection of tests, the calibrations can be run. In this case, the interval of the automatic calibration starts when tests are run. In case the calibrations aren’t run, then the time count of calibration’s interval starts from the moment the selection was made. Once the automatic calibration time has elapsed a message appears on the screen asking the operator if the tests need to be run. If the standards and reagents are on the tray answer yes. At this point the automatic calibration time restarts.

If the message is not answered or a negative answer is given, the calibration time count starts again. The previous calibration remains in the memory. If the timing expires while the analyzer is in standby, it will be automatically moved 10 minutes forward.

Running Controls

Controls Sera can be run on command or automatically, according to programmed time intervals (refer to Chapter C, paragraph 1.4. Controls). The two modes can coexist. Commands are Immediate Controls and Timed Controls (Fig. 4).

Immediate Controls:

Clicking this button generates a list of codes. With Select All or Deselect All commands, it is possible to select or deselect the whole list.

The single levels for each type of control can be selected at the same time for all the tests present, by clicking on the relative button, which will change color from dark green to light green.

Select the desired tests and run by pressing Run.

A message will ask the user whether the control samples are already present in the tray or not. If samples are already present, click Yes and run will automatically start. Otherwise, if controls samples aren’t already placed on the tray, click No; in this case a guided procedure is presented for samples’ insertion. By clicking over sample’s position, the tray moves itself to accommodate cup’s insertion. After the insertion of necessary cups, run the controls. Timer-driven Controls:

Only the codes with programmed times are enabled.

When the listed tests are selected the controls can be executed, in this case the automatic execution time interval starts from when the test begins, if the controls are not executed the execution time count starts from when the selection is carried out. When the automatic execution time has elapsed a message appears on the screen asking the operator if the tests need to be executed. If the operator answers yes, it checks for the presence of the controls and reagents and starts the tray.

If the message is not answered or a negative answer is given, the control time count starts again. If the timing expires while the analyzer is in standby, it will be automatically moved 10 minutes forward.

Standards, Controls and Patients Run

The analyzer allows the associated running of standards, controls and patients. The standards can be processed before, during or after patients’ run. These three options provide the analyzer with maximum operating flexibility.

To run the calibrations during the patients determinations, proceed as described above. The analyzer will calculate the factors for the calibrations being run and update the result page in real time (by patient). If no errors occur in the calibrations, the results of the next patients will be calculated with the new factors at the end of the calibrations. The results of the patients before the calibrations will be calculated with the previous factors. When finished working it is possible to recalculate all the results based on the last executed calibration, again if there have not been any errors. This function is available on the result page in real time for patients (see Ch. G, par. 1. Displaying and printing results).

Press the Correction button and select the correction with standard. This way all the results will be recalculated based on the last calibration.

NOTE:

In case of analytical errors during calibrations, the analyzer displays the error type and conserves the previous validated calibrations in the analyzer memory.

1.4. SAMPLES

Entering Samples (Routine, STAT, Controls and Batch)

Samples can be entered with Insert Routine/STAT or with Insert Batch. These can be accessed from Patients main menu or from dedicated icons. Select Exit to leave the program. The represented analyses codes pertain to the list generated in the Create current tray.

Insert Routine/STAT: The following options are available in this page Global Insert/View Patients (Figure 5):

Figure 5

NOTE:

Re-run: allows tests which have been run and not archived to be re-run (repetitions) on user’s demand.

Routine: Default display of Patient positions.

STAT: Displays STAT (Single Test in Actual Time, i.e. urgent positions) positions. Control: Displays Control positions.

Standard: Displays Calibrators positions.

New Entry: Enables data entry procedure for Routine, STAT and Controls.

Extra Patients: Displays the list of patients with no assigned position. Patients selected in the work-list may be moved here ("Options" menu, "Send to extra patients" command) and then back.

Exit: To leave program New Entry Routine:

After the selection of Routine followed by confirmation through command New Entry, the patients acquisition frame is displayed (Figure 6). The programmed patient can be executed immediately or saved for later use. The programming fields and the functions are outlined below:

Figure 6A

Figure 6

Group: Select the group (Man, Woman, Child) for correct reference with normal values range.

Type: It is default set to Serum. The sample type (Serum or Urines) is selected here. If Urine is selected, then the volume of diuresis (in the 24h) is requested. This is required for processing data acquired with automatic calculation on 24 hours. If this processing is not required then leave the value at zero "0".

Assigned Group (Routine or CTRL Routine): The default setting is Routine. It is used for selecting the category (Patient or Control Serum) during sample programming. Selecting CTRL Routine the type (Known or Unknown) and levels (Level 1, 2, 3) must be specified.

NOTE:

With this type of acquisition, the controls belonging to the stored Q.C. will use the positions assigned to routine patients, not the dedicated ones.

Position: Displays the first free position from the available positions. To modify this field use horizontal arrows ⇐ ⇒or type in the desired position. Do not modify to accept.

Code: It is the identification number assigned by the user to the patient. The user can also enter the code of a patient saved in the work list, even if in execution. In this case, a message asks the user to confirm patient’s data cloning. In case of affirmative response, all the data relevant to the patient is instantly displayed and is linked to the current position. The cloning of a patient’s code allows the user to obtain one report in case different samples are used. If this option is not used, then separate reports are obtained.

Duplicate patient: By clicking on the icon, it is possible to create a worklist with the same profile (Autobatch) or else a list with sequential codes. When the patients are entered using the duplication method, their codes may be assigned by the analyzer, or it may be a progressive number. In the case of progressive number, the operator must enter the first code to be used.

Surname, Name: Enter patient’s personal data.

Draw Date: System date is automatically displayed. To modify, move mouse cursor on textbox, click and edit.

Note: Additional information to be added to the report.

External Dilution Factor: By default set to "1". It allows analysis determination on externally diluted samples. Enter in this field the external dilution factor ratio used in sample preparation. Final result is multiplied by the inserted ratio.

CAUTION!

IN THIS CASE THE PRE AND POST DILUTION FACTORS OF TEST PARAMETERS