Software Structure .1 Menu Structure

The top level structure of the system menu includes 8 functional options: analysis, review, QC, calibration, setup, service, logoff and shutdown. Operators can enter the screens to perform the functions of the analyzer through the system menu. The " " indicates there is sub-menu under the option. Refer to Figure 2-3 -- Figure 2-7 for the full menu structure.

The menu structure of service access level:

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Figure 2-3 Top level menu and QC sub-menu

Figure 2-4 Top level menu and calibration sub-menu

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Figure 2-5 Top level menu and setup sub-menu

Figure 2-6 Top level menu and setup sub-menu(2)

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Figure 2-7 Top level menu and service sub-menu

2.4.2 Password

The login service ID is "Service", password is "s 3600!", case sensitive and space required.

With service access level, you can perform all functions that are open to common users and some other special functions:

1、 Transfer factor calibration function:

1） Under whole blood mode, click "Menu"—>"Calibration"—>"Calibrator", finish the calibration successfully, exit and save the calibration factors.

2） Click "Menu"—>"Calibration"—>"Transfer factor" to enter the screen in Figure 2-8, run the sample used in the above step for 5 consecutive times under whole blood mode, check if CV(%) meets the requirements in Table 2-13; if not, cancel a abnormal result and calculate again (results of at least 5 analyses required), then check if the requirements in Table 2-13 are met.

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Figure 2-8Analysis screen of transfer factor under whole blood mode

Table 2-13 Whole blood CV range Param

eter

WBC RBC HGB MCV PLT

CV value

≤2.0% ≤1.5% ≤1.5% ≤0.5% ≤4.0%

3） Click the "Predilute" button to switch to the screen of predilute mode, as Figure 2-9 shows;

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Figure 2-9 Analysis screen of transfer factor under predilute mode

4） Click the Diluent icon, perform diluent dispensing for 7 consecutive times;

5） Add 140µl of calibrator in to the diluent, mix thoroughly and then run the mixture for more than 5 times under the predilute mode. The CV(%) values must meet the requirements of Table 2-14, and the calibration factors are within the range [0.75, 1.25].

Table 2-14 Range of CV value under predilute mode Param

eter

WBC RBC HGB MCV PLT

CV value

≤4.0% ≤2.0% ≤2.0% ≤1.5% ≤8.0%

2、 The gain of WBC and RBC can be adjusted, see Figure 2-10;

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Figure 2-10 Gain setup screen

3、 In the service setup screen, you can set up languages, software upgrade, volume of the volumetric tube, analyzer SN, sample probe positioning adjustment, background information monitoring (auto adjust of analysis time), rinse photocoupler calibration, etc.

The following section will introduce the sample probe positioning adjustment and rinse photocoupler calibration functions.

1) Sample probe positioning adjustment:

Tool: the positioning calibration clamp of sample probe sampling position

Procedure: open the cover as Figure 2-11 shows, open the sample compartment door, take out the tube holder adapter from the compartment, put the positioning calibration clamp to the sample compartment, and then close the compartment door.

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Figure 2-11 Sample compartment

Click the "Aspirate pos." under the "X direction motor" as shown in Figure 2-12, and click

"Start", then click the "Move Left" or "Move Right" button to move the sample probe to the top of the positioning hole of the fixture, check if the tip of the probe is right against the positioning hole, then click "Save" to save the setting.

Figure 2-12 Sample probe positioning adjustment

Note: the tip of the probe must be right against the positioning hole (judge by visual inspection).

2) Rinse photocoupler calibration Tool: 101 slot-headed screwdriver

Procedure: as Figure 2-13 shows, click "Menu""Setup""Service Setup""Photocoupler Cal.", the dialog box shown in Figure 2-14 will pop up.

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Figure2-13 Rinse photocoupler calibration menu

Figure2-14 Rinse photocoupler calibration screen

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①①

①① Click "Start" and then click "OK", the dialog box "Priming diluent" will pop up, then an instruction message will be displayed, use the slot-headed screwdriver to rotate the potentiometer VR1(RINSE) on the drive board (see Figure 2-15) counter-clockwise until the D22 (RINSE-LED) turns on. Note: continue to rotate the VR1 for 180 degrees after the D22 turns on.

Figure 2-15

②

②

②② Connect the connector of the rinse pickup tube to the fitting on the back panel of the analyzer, click "OK" and then click "Finish", the dialog box "Priming rinse" will pop up, check the calibration status then: if "Pass" is displayed (see Figure 2-16), that means the calibration succeeded. The reference voltage and measured voltage are displayed as "Reference(V)" (1.8-3.0V) and Actual(V) in Figure 2-16.

Figure 2-16 Note:

①

①

①① Rotate the VR1 for 180 degrees more after the D22 turns on, and make sure the LED is illuminated.

②

②

②② Do not modify the value in the edit box Max(V), Min(V) and Factor(V);

③③

③③ If calibration cannot be done successfully due to the quality of the photocoupler itself and the PCBA or photocoupler must be replaced, then recalibration is needed. The dialog box "Remove the Rinse tube from the container and press [OK] to continue."

will pop up, press [OK] to drain the tubing; then do as instructed by the prompt - "1.

Adjust rinse photocoupler potentiometer till the RINSE-LED turns on; 2 Put the Rinse tube into the container and press [OK]to close the dialog box; 3. Click [Finish] button"

to prime rinse after calibration is done.

"PASS"

displayed

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4、 The reproducibility and carryover functions are available.

Figure 2-17 Menu of reproducibility and carryover

5、 Check the replacement status of boards and CF card automatically. If the software system is started and logged in by user of service level, then a prompt will guide the user to restore the critical data.

Figure 2-18

1) If a new CF card is replaced, follow the guidance to select "Restore" and restore the critical data to the CF card.

2) If a new data board is replaced, follow the guidance to select "Backup" and backup the data to the data board.

3) If only the drive board is replaced, no special action shall be taken, the data will not be

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6、 Users of the service level can export special information, see the figure below.

Figure 2-19