Frequently Asked Questions
Precision is a check of the instrument's routine operation and is designed to verify proper instrument performance. Precision may be used as part of troubleshooting and should always be run prior to calibration to ensure successful calibration. A proper precision check requires a fresh, normal whole blood sample < 4 hours old at beginning of the procedure and < 8 hours old at end of the procedure, processed 10 to 20 times (as specified in analyzer Operator’s Manual), making sure sample is well mixed between runs. Verify precision by comparing CV% values for designated parameters to specifications listed in CELL-DYN Operator's Manual, Section 6: Calibration, Pre-calibration Worksheet. These reference CV% values for fresh, normal whole blood have been determined according to regulatory recommendations.
CD1000 Series
Where can I find the serial number for my instrument?
The serial number is located near the power switch on the right side of the instrument.
What are the acceptable limits for the CV% on the Open Mode Precision Procedure done as a pre-calibration requirement?
The CV % limits are found in the Operator’s Manual
CD1800 Operator’s Manual, 9140390C- March 2004, Sect 4, page 4-15, Table 4.7
CD1700 Operator’s Manual, 9140264D- August 2004, Sect 4, page 4-18, Table 4.7
During a recent inspection, the inspector discussed running a background before running a patient sample. Is this required before each patient?
The Operator’s Manual, under Running Specimens states, “If the system is idle for 15 minutes or more, a normal background should be run immediately prior to running patient specimens.”
CD1800 Operator’s Manual, 9140390C- March 2004, Sect 5, page 5-49 under Normal Background
CD1700 Operator’s Manual, 9140264D- August 2004, Sect 5, page 5-4 Daily Start-up Procedure, step 4d
RUBY/CD3000 Series
How do I establish QC ranges?
The expected ranges published by manufacturers are generally too broad for effective Quality Control. Therefore, each laboratory should establish acceptable ranges. These ranges may be determined by evaluating three to six months of data (data from the Interlaboratory QC Program may be used) for a particular level of control. The individual SD (standard deviation) values may be averaged as follows:
SD = standard deviation of values in that group
i = the last group of values
The resulting long-term instrument SD and the laboratory-established mean for each lot number should be used to monitor instrument performance.
Example: Your new Lot mean for WBC is 2.0, with a 1SD (from historical data) of 0.1 multiplied by 2 would be 0.2, i.e. WBC 2.0(+/-0.2) or 1.8-2.2.
Information can be found in the CELL-DYN 3200 ® System Operator’s Manual, Section 11.
Where can I find CV% for Precision for CD3200?
CELL-DYN ® 3200 System Operator’s Manual, Section 4 or see attached table.
The stated CV% in the following Table represents the instrument precision at a
95% confidence level from N = 20 replicate runs based on the same sample.
How do I move my QC data from one file to other file on the CELL-DYN 3200?
- From the QC MENU screen, use the Arrow keys on the keyboard to move the cursor to the file containing the specimen to be moved.
- Press [VIEW QC LOG].
- Use the Arrow keys on the keyboard to position the cursor at the result that is to be moved.
- Press [MOVE SPECIMEN] to again display the VIEW QC LOG screen.
- Use the Arrow keys on the keyboard to move the cursor to the file in which the results are to be placed.
- Press [MOVE TO FILE] to move the results to the designated file.
NOTE: The result is moved to the end of the list of data that is currently in the file. - The VIEW QC LOG screen of the original file is displayed showing that the results have been moved.
Information can be found in the CELL-DYN 3200 ® System Operator’s Manual; Section 11.
SAPPHIRE/ CD4000 Series
Why is my CD4000 printer no longer printing my reports after a service visit?
Your Service Representative may have disabled the printer by changing its settings during troubleshooting. Check your print setup screen and make sure all settings are correct. If any are not, modify them appropriately and print a test page. If all settings are correct and reports are still not printing, contact Customer Support for assistance in troubleshooting the issue.
Why does my Sapphire Brother 2700CN printer shut down/ stop printing every time it sits idle for any period of time? I have to keep restarting it to print.
The Brother printer is designed to go into power save mode (sleep mode) when idle to reduce operation costs, unless this mode is turned off. If the printer is going into power save, please contact Customer Support for directions to disable the sleep mode.
eQC
I received the following message during monthly upload “Errors were detected while reading the (low/normal/high) level file.” What does this message mean?
During monthly upload, you must select the correct lot in use in the upload data screen at the time QC was run for that month. If the lot number selected does not match the Lot information on the downloaded disk, this message will occur.
If you continuously use the same file each month and purge your monthly QC data after upload, all lot and expiration data information will be deleted. You must re-enter lot and expiration date prior to the next monthly upload, even if same lot is in use for subsequent months.
