Wash I.S.E. Module: It is used for a complete extra wash with appropriate solutions (ISE Cleaning Solution and Enzymatic Solution) of the fluidic circuit of the ISE module This
2. OPERATING THE I.S.E MODULE 1 PARAMETERS
Go to the Global list or the Current Tray list select ISE, and then click Parameters to display the screen showing analytical parameters: General Parameters, Serum’s Parameters, and Urine’s Parameters.
N.B.: the I.S.E. parameters have been optimized for this analyzer. The parameter fields marked with an asterisk should not be modified. Biotecnica Instruments S.p.A. shall not be held liable for unreliable results if the I.S.E. parameters are changed.
The General Parameters is displayed first (Figure 1), to access the other parameters click on the corresponding tags.
GENERAL PARAMETERS: In this page it is possible to program the general parameters for the ISE. The I.S.E. module test parameters are preset and should not be modified because the I.S.E. module has been designed to operate best with the parameters supplied by Biotecnica. The description and use of the parameters is very similar for what is described for clinical chemical parameters, see that section for more information.
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Sample µl: Sample volume expressed in µl,default value is 30µl for BT3000 Plus and 23 µl for BT3500.
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Serum dilution 1:: Sets dilution ratio between sample and reagent, default value is set at 14.*
Reagent dilution 1: Sets dilution ratio for concentrated reagent, default value is 9. Using this parameter the analyzer prepares (dilutes) the working reagents such as Reference (Baseline) Solution and Buffer Solution, which are CONCENTRATED.1st Unit: Enter value in the corresponding field and enable 2nd Unit to enter a second value and
instantly a new textbox appears where the user can enter the second unit and the second unit’s conversion factor. In case of double units, the test values are expressed with two results. In analytical calibrations, the first measurement unit is used.
Figure 1
Number of Washes: Normally one wash is usually sufficient. To set a different number of washes (maximum 9) use up/down arrow keys v or enter the value directly into the box. This option allows the user to set the number of washes that will be run at the end of dispensing the reagent used for the programmed test.
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Incubation Time: Incubation time expressed in seconds, default value is 2 seconds.*
Reading Time: Analysis’ reading time, expressed in seconds, default value is set at 4seconds.Decimals: For setting the number of decimal digits in test results (Automatic or Custom). If a value is not specified, then the analyzer automatically assigns number of decimal digits using the Floating point algorithm.
Electrodes in use (K Na Cl CO2): Click the check boxes to select the electrodes to be used among those available here. This command selects or deselects electrode. When an electrode By-pass is used it is necessary to deselect the electrode which is not used to prevent continuous errors during calibration. If the selection of electrodes being used is modified, it is necessary to repeat the calibration.
SERUM’S PARAMETERS: Here it is possible to assign the Normal range (Figure 2) for each electrode and, if needed the panic range for pathological repetition. The programming of the normal range values for Man, Woman and Child is assigned specifically to each electrode. To assign the normal (and panic) range to each electrode, click corresponding tag.
To visualize the Panic range, click Re-run pathological checkbox. If Re-run pathological option is selected, the analyzer will repeat all pathological results outside the given range.
Figure 2
URINE’S PARAMETERS: In addition to the same functions as the Serum’s Parameters, it also has the µl Water field (Figure 3). This is used for entering the volume in µl of water that must be used for washing the hydraulic circuit at the end of a test determination.
Note: The CO2 electrode is automatically
excluded In Urine’s parameters (it does not appear even if it is present in the electrodes in use).
The Instrumental factor and Shift fields are available for both serum and urine, separated by single electrode.
Figure 3
• Instrumental factor: introduces a correction of the final datum of the executed test; it can be used to adjust the data of the executed test with different types or analytical methods or instruments. Calculation: final result = value x instrumental factor.
• Shift: the function introduces a quantitative correction of the final datum of the executed test; it can be used to adjust the data of the executed test with different types or analytical methods or instruments. Calculation: final result = value + shift.
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NOTE: When the following parameters are used at the same time: Instrumental factor and Shift, External dilution factor and Urine 24/h (in the patient’s data), the calculation made by the analyzer will be as follows:
[(obtained result x External dilution factor x Instrumental factor) + Shift] x Urine 24/h
At the end of programming press the Save button to save the inserted data, otherwise press Cancel.
2.2. PROGRAMMING STANDARDS AND CONTROLS
INSERTING STANDARDS: Go to the Global list or the Current Tray list. Select ISE, and then click Standards to display the Standard parameters for ISE (Figure 4). Standards programming (automatic or on request) follows the same procedure of Clinical Chemistry (Chapter C, paragraph 1.5. Calibrations). For system calibration, two known standards (Low and High) are required.
The Calibration parameters of the module and the relevant slopes calculated for each electrode are displayed together. Here it is possible to set an automatic standardization timer and assign two positions for low and high standards (same as clinical chemistry procedure outlined in Chapter C, paragraph 1.5.).
Low standard position and High standard position: write in these fields or select with up/down arrow keys v the positions for I.S.E. calibrators.
Timed re-run: It is possible to program automatic execution of calibration using this parameter. The analyzer will issue a warning message when the programmed standardization ends. If the reagents and standards are present, then one can directly perform the calibration. Insert the standardization time by enabling Time selection and program the corresponding field. One can enter interval of hours or days in this field.
Figure 4
Last Standardization: The time and date of last test positive calibration are shown here. Slope: After each calibration, the calculated values for the slopes are updated in these fields. Calculated slope values must be within the indicated ranges.
Slope Min / Max: By double- clicking the textboxes, slope ranges are individually set for each electrode. Refer to test methodology for correct values. The slope values are important for verifying a correct calibration and the electrodes status. When a slope is out of range, it will probably mean that the electrode must be replaced.
Standard Low/High: Double clicking in the appropriate fields it is possible to program the concentration values of the two standards for each electrode. Every time standards are changed, the set points must be changed as well. Refer to the kit insert or to the standards label for the correct values.
BSF: This parameter is a Base Line Factor and is used for Cl and CO2. It must be set to 5. It is a linearity correction factor.