Factor Test
Perform the Rate/CM Correction Factors Test whenever you change the reflectometer lamp and encounter unacceptable quality control values on multiple tests, or when instructed to do so by your Customer Support Representative.Ensure that the reflectometer iris is adjusted properly before performing the Rate/CM Correction Factors test. If you don’t know how to adjust the reflectometer iris, see the instructions in the next section, “Reflectometer Iris Adjustment.”
To perform this procedure you will need:
• VITROS White Reference Slides (Part Number 994723)
• VITROS Black Reference Slides (Part Number 994724)
NOTE: White Reference Slides are also referred to as White Correction Factor (WCF) Slides.
Black Reference Slides are also referred to as Black Correction Factor (BCF) Slides.
To access the Rate/CM Correction Factors test screen and begin using the Rate/CM Correction Factors test feature:
1. Touch RATE/CM CORRECTION FACTOR on the Setup/Adjustments screen.
The next screen will read:
“Warning: Adjustments made to the mechanism may result in significant changes in analyzer performance. All adjustments should be made by qualified personnel only. If adjustments are made, all changes should be saved on a backup diskette.”
— If you don’t know how to backup information to a diskette, see Chapter 10,
“Options,” in the Operator’s Manual.
2. Touch CONTINUE to proceed with the Rate/CM Correction Factors test.
Rate/CM Correction Factor Test
3. Wait while the incubator and slide transport mechanisms initialize.
The screen will display the wavelengths and white slide assay values. The prompt line will ask if you want to use the current assay numbers.
DIAGNOSTICS – Setup/Adjustments – Rate/CM Correction Factors Oct 09 92 14:13:12 VX.XX**250 SS1 SS2 ST INC R/C PM INOP
LAB COMP : TESTING COMPLETE
SAMPLING OFF ON
> Use current assay numbers? (Y/N):
SA20B Wavelength White Slide Assay
340 nm 0.44020
400 nm 0.76700
460 nm 0.82310
540 nm 0.83690
600 nm 0.83770
630 nm 0.83800
670 nm 0.84120
680 nm 0.84140
RETURN TO MAIN DIAG
MENU
RETURN HELP
Rate/CM Correction Factor Test
4. Compare the displayed assay values to the assay values on the carton of White Reference Slides.
— If the correct values are not on the screen, type “N” for no. Then type the correct assay value from the carton, and press the Enter key on the keyboard for each of the wavelengths displayed.
— If the values are correct, type “Y” for yes and press the Enter key on the keyboard.
The screen will display the wavelengths, assays, and current white correction factors.
DIAGNOSTICS – Setup/Adjustments – Rate/CM Correction Factors Oct 09 92
1) Empty used slide bin and put in a clean catch cloth.
2) Lift incubator cover and put White slide on labelled slot.
3) Insert White Correction Factor Slide completely into incubator.
4) Lower incubator cover and touch START.
SA20C Wavelength White Slide Assay Current WCF
340 nm 0.44020 0.38012
400 nm 0.76700 0.72690
460 nm 0.82310 0.81089
540 nm 0.83690 0.82392
600 nm 0.83770 0.81384
630 nm 0.83800 0.81181
670 nm 0.84120 0.81211
680 nm 0.84140 0.81185
RETURN TO MAIN DIAG
MENU
RETURN START HELP
Rate/CM Correction Factor Test
5. Lift the top right cover of the analyzer.
6. Open the incubator cover.
Incubator Cover
Rate/CM Correction Factor Test
7. Place a White Reference Slide on the labeled slot at the front of the incubator.
Position the slide with the ribbed side down, notch toward the incubator.
8. Push the slide into the incubator so that the incubator cap closes.
9. Close the incubator cover and touch START. The analyzer will reposition the slide.
10. The analyzer will now display the wavelengths and black slide assay values. The prompt line will ask if you want to use the current assay numbers. Compare the displayed black assay values to the assay values on the carton of Black
Reference Slides.
— If the values on the screen are not the same as the values on the carton, type
“N” for no. Then type the correct assay values from the carton for each of the wavelengths displayed.
— If all the values are correct, type “Y” for yes and press the Enter key on the keyboard.
11. The screen will display the wavelength, assays, and current black correction factors.
12. Place a Black Reference Slide on the labeled slot at the front of the incubator.
Position the slide with the rib side down, and line up the notch in the slide with the label in front of the incubator slot.
Slide Incubator
Rate/CM Correction Factor Test
13. Push the slide into the incubator so that the incubator cap closes.
14. Close the incubator cover and touch START.
— The analyzer will reposition the slide.
— The test takes approximately twelve minutes to complete 92 read cycles.
The screen displays and updates the number of cycles completed until it reaches approximately 84 read cycles. The screen will then go blank because of the screen-saver feature of the analyzer. Touch the screen or press any key on the keyboard to reactivate the screen.
— The analyzer will discard the used white and black reference slides automatically. Do not reuse these slides.
— The new correction factors are displayed on the summary screen when the test is finished.
DIAGNOSTICS – Setup/Adjustments – Rate/CM Correction Factors Oct 09 92
Wavelength New WCF White Dr S.D. New BCF Black Dr S.D.
340 nm ** 0.38175 ** 0.00055 *** 0.00097 ** 0.00081 400 nm 0.84258 ** 0.00026 *** 0.00042 ** 0.00100 460 nm 0.90888 0.00007 *** 0.00015 ** 0.00120 540 nm 0.94045 0.00008 *** 0.00074 ** 0.00115 600 nm 0.95488 0.00004 *** 0.00081 ** 0.00170 630 nm 0.95760 0.00008 *** 0.00071 ** 0.00101 670 nm 0.95473 0.00011 *** 0.00097 ** 0.00076 680 nm 0.95769 0.00008 *** 0.00078 ** 0.00129
Summary
Rate/CM Correction Factor Test
15. Display and print both the white correction factor data and the black correction factor data.
• Touch DISPLAY WHITE DATA. The White Correction Factors screen appears.
• Print the screen for your laboratory’s quality control records by pressing the PrtScr key.
• Touch DISPLAY BLACK DATA.
• Print the screen for your laboratory’s quality control records by pressing the PrtScr key.
DIAGNOSTICS – Setup/Adjustments – Rate/CM Correction Factors Oct 09 92
Wavelength White Assay Current WCF New WCF Dr S.D.
340 nm 0.35680 0.42808 ** 0.38175 ** 0.00055
400 nm 0.74230 0.86311 0.84258 ** 0.00026
460 nm 0.81610 0.91215 0.90888 0.00007
540 nm 0.83770 0.93112 0.94045 0.00008
600 nm 0.83940 0.94345 0.95488 0.00004
630 nm 0.83960 0.94681 0.95760 0.00008
670 nm 0.83630 0.95046 0.95473 0.00011
680 nm 0.83770 0.95221 0.95769 0.00008
White Correction Factors
DISPLAY
> Touch DISPLAY BLACK DATA to display more data.
Rate/CM Correction Factor Test
16. Touch RETURN to return to the Summary screen.
— The Summary screen may show two or three flashing asterisks before some correction factors or standard deviations (S.D.s). The table below explains what the asterisks mean.
Number of
Asterisks Condition
None • New correction factor (WCF or BCF) is within 5% of original value.
**
• New correction factor (WCF or BCF) is within 5% to 15% of the original value.
OR
• New White or Black Dr S.D. is more than .0002 from the original value.
***
• New correction factor (WCF or BCF) is more than 15% of the original value.
DIAGNOSTICS – Setup/Adjustments – Rate/CM Correction Factors Oct 09 92
Wavelength New WCF White Dr S.D. New BCF Black Dr S.D.
340 nm ** 0.38175 ** 0.00055 *** 0.00097 ** 0.00081 400 nm 0.84258 ** 0.00026 *** 0.00042 ** 0.00100 460 nm 0.90888 0.00007 *** 0.00015 ** 0.00120 540 nm 0.94045 0.00008 *** 0.00074 ** 0.00115 600 nm 0.95488 0.00004 *** 0.00081 ** 0.00170 630 nm 0.95760 0.00008 *** 0.00071 ** 0.00101 670 nm 0.95473 0.00011 *** 0.00097 ** 0.00076 680 nm 0.95769 0.00008 *** 0.00078 ** 0.00129
Summary
Rate/CM Correction Factor Test
17. Follow the instructions below to determine when to update correction factors.
If Summary Screen Shows: Update?
• Two asterisks (**) or no asterisks in the New WCF or White Dr S.D.
columns (no values with three asterisks)
AND
• New BCF values are all within typical range1
Yes.
Continue with step 18 on the next page.
• Two asterisks (**) or no asterisks in the New WCF or White Dr S.D.
columns (no values with three asterisks)
AND
• Any New BCF value is outside of typical range1
No.
Check for errors2 and repeat test.
Call your Customer Support Center if New BCF values are out of range after you repeat the test.
• Any New WCF or White Dr S.D.
value with three asterisks (***) AND
• New BCF values are either within or outside of typical range
Yes—if service was performed or you have a new lot of correction factor slides.3 Continue with step 18 on the next page.
Otherwise, check for errors2 and repeat test.
Call your Customer Support Center if any New WCF or White Dr S.D. values have three asterisks after you repeat the test.
1 It is common for three flashing asterisks to appear in front of New BCF values, regardless of how many times the correction factors test is repeated. Typically, BCF values should fall in the range [-0.0020 to 0.0020].
2 Check for the following errors and repeat the correction factors test.
— Ensure that the reference slides were inserted correctly. Reference slides should be inserted ribbed side down.
— Ensure that the assay values from the White or Black Reference Slide cartons were entered correctly.
3 Three asterisks in front of New WCF values usually indicates that something has changed in the analyzer’s optical system. This can happen if a service procedure has just been performed, such as the installation of a new internal reference or a new lamp.
Rate/CM Correction Factor Test
18. The prompt line will ask if you want to update the correction factors
automatically. If you update the correction factors, repeat the entire correction factors test again from step 1 to verify the new values.
— To update the correction factors automatically, type “Y” for yes and press the Enter key on the keyboard. The update takes about ten seconds.
— To end the test without updating the correction factors, type “N” for no and press the Enter key on the keyboard.
Warning: If you update the correction factors with inappropriate values, patient results may be affected. If this happens, you can manually re-enter previous correction factors from the printouts you made in step 15 using “WCF Manual Entry,” found in the Operator’s Manual.
19. Close the analyzer covers.
20. Touch RETURN to return to the Setup/Adjustments screen, or touch RETURN TO MAIN DIAG MENU to return to the main Diagnostics screen.
21. The prompt line will ask you to confirm that you want to return to the Setup/
Adjustments screen. Type “Y” for yes and press the Enter key on the keyboard.
22. The analyzer will initialize when you exit Diagnostics.
Run and evaluate quality control fluids to ensure all tests are performing correctly.