Pentra XLR Daily Guide PDF [PDF]

Zitiervorschau

Hematology Analyzer

Daily Guide Ref: RAB290CEN

Daily Guide

Daily Guide Ref: RAB290CEN

Contents 1. Revisions..................................................................................................1

6. Running Blood Specimen................................................................15

2. Software Overview...............................................................................2

6.1. To Run the Specimen in Rack Mode............................................................ 15 6.2. To Run the Specimen in STAT Mode............................................................15

2.1. Contextual Toolbar Description..................................................................... 2 2.2. Function Toolbar Description........................................................................ 3 2.3. Main Menu Buttons...................................................................................... 4 2.4. Logs Menu Buttons......................................................................................4 2.5. Quality Assurance Menu Buttons...................................................................5 2.6. Service Menu Buttons.................................................................................. 6 2.7. Settings Menu Buttons................................................................................. 6 2.8. Cycle Selection Button................................................................................. 7

3. Start of Day............................................................................................. 8 3.1. To Check the Waste Container Level............................................................. 8 3.2. To Switch the Printer On .............................................................................. 8 3.3. Starting the Instrument................................................................................. 8

4. Running Quality Control Blood..................................................... 11 4.1. To Run a Control Blood in Rack Mode......................................................... 11 4.2. To Run a Control Blood in STAT Mode.........................................................11 4.3. To Check Control Blood Results..................................................................12

5. Worklist...................................................................................................13 5.1. To Create a New Order in Grid View............................................................ 13 5.2. To Create a New Order in Rack View........................................................... 13 5.3. To Search Orders.......................................................................................14

Daily Guide Ref: RAB290CEN

7. Results Matching................................................................................17 7.1. Sample Identification..................................................................................17 7.2. To Manually Match Results......................................................................... 17

8. Results Management........................................................................ 18 8.1. To Filter Results......................................................................................... 18 8.2. To Customize Results.................................................................................18 8.3. To Validate Multiple Results........................................................................ 18 8.4. To Validate a Single Result..........................................................................19 8.5. To Reject Multiple Results...........................................................................19 8.6. To Reject a Single Result............................................................................ 19 8.7. To Rerun a Sample Manually.......................................................................20 8.8. To Print your Results.................................................................................. 20 8.9. To Send Results to the LIS..........................................................................20

9. Results Interpretation.......................................................................22 9.1. General Alarms.......................................................................................... 22 9.2. Morphology Alarms.................................................................................... 24 9.3. Suspected Pathologies...............................................................................29 9.4. Analyzer Alarms......................................................................................... 31 9.5. Statistical Function Alarms..........................................................................32 9.6. Delta Check...............................................................................................32

i

10. Archives............................................................................................... 34 10.1. To View Archived Results..........................................................................34 10.2. To View Exported Results......................................................................... 34 10.3. To Print Archived Results.......................................................................... 34 10.4. To Send Archived Results to the LIS.......................................................... 35 10.5. To Delete Archived Results....................................................................... 35

11. End of Day...........................................................................................36 11.1. Statistics................................................................................................. 36 11.2. To Change Operator.................................................................................36 11.3. Stopping the Instrument........................................................................... 37

Daily Guide Ref: RAB290CEN

ii

Revisions

1. Revisions Index

Reference

Software Version

Document Date Issued

A

RAB290AEN

2.0.x

June 2013

B

RAB290BEN

2.0.x

November 2013

C

RAB290CEN

2.2.x

April 2014

This document applies to the latest software version listed and higher versions. When a subsequent software version changes the information in this document, a new electronic edition (DVD-ROM and/or online help) is released and supplied by HORIBA Medical. To update a paper document, please contact your local HORIBA Medical representative. ■ This instrument is intended for professional use only. ■ The user manual is supplied on the DVD-ROM and must be consulted prior to operating the instrument. ■ Please refer to the user manual for potential hazards and risks, technical specifications and performance data. ■ This document is only a guide for daily usual operations and cannot replace the instrument user manual.

If a problem occurs or an alarm is displayed during the instrument operation, refer to the user manual instructions for recommendations. If the problem persists, please contact your local HORIBA Medical representative.

Documentation DVD-ROM instructions To view or to print the user manual or any other document included in the Documentation DVD-ROM, place it into a computer drive and follow the instructions. YOUR LOCAL REPRESENTATIVE:

Daily Guide Ref: RAB290CEN

1

Software Overview Contextual Toolbar Description

2. Software Overview The Pentra XLR includes a software application that allows you to navigate in the various menus. The touch screen allows easy and direct access to all functions via icons.

Press the icon or use the external mouse to activate corresponding functions.

2.1. Contextual Toolbar Description Depending on the screen currently displayed, buttons of the contextual toolbar may change. Buttons listed below are the most commonly displayed: Help: displays the help.

Print/Send: allows to print data.

The main menu includes the following items: ■ The contextual toolbar (horizontal), which provides functionalities related to the screen currently displayed. ■ The function toolbar (vertical), which provides a direct access to other functionalities. ■ The main menu buttons (center of the screen), to enter the submenus. ■ StartUp to perform a Startup cycle manually. ■ ShutDown to perform a Shutdown cycle manually. ■ The status bar (bottom of the screen), which gives indication on the date, time, software version, operator code and the cycle in progress.

Daily Guide Ref: RAB290CEN

Detail: displays more details regarding the current screen.

Insert: inserts new data.

2

Software Overview Function Toolbar Description

Delete: deletes an item or data.

2.2. Function Toolbar Description

STOP: stops the instrument (emergency stop). Edit: allows to modify data.

Alarm: displays the list of alarms. Validate: validates an action.

Worklist: opens the worklist. Cancel: cancels an action.

Start Rack: runs an automatic sampling. Return: goes back to the previous screen.

STAT Mode: runs a manual sampling. Quit: quits the application.

Report: opens the list of reports.

Archive: opens the archived results.

Daily Guide Ref: RAB290CEN

3

Software Overview Main Menu Buttons

2.3. Main Menu Buttons

Service: opens the service menu.

StartUp: launches a Startup cycle. Settings: displays the settings screen. ShutDown: launches a Shutdown cycle.

Logs: opens the instrument logs menu.

2.4. Logs Menu Buttons Quality Assurance: gives access to QC, XB, calibration and repeatability. Maintenance: displays the list of maintenance procedures performed. Run in Progress: displays a list of the samples currently running. Data Handling: displays logs related to patients. Status: displays the reagents monitoring screen. Host: displays events related to sent or printed data.

Errors: displays the list of all the errors that occurred on the instrument.

Daily Guide Ref: RAB290CEN

4

Software Overview Quality Assurance Menu Buttons

Blank Cycle: displays blank cycle results.

2.5. Quality Assurance Menu Buttons

XB: displays the XB graphs. Calibration: displays events related to calibration. Quality Control: displays active blood controls and gives access to QC Management screen. Settings: displays settings performed on the instrument.

Within Run: allows you to perform a repeatability test on the instrument. Quality Control: displays events related to quality assurance.

Calibration: allows you to calibrate the instrument. Reagents: displays events related to reagents.

Logs per Day: displays all the events that occurred at a given date.

Daily Guide Ref: RAB290CEN

5

Software Overview Service Menu Buttons

2.6. Service Menu Buttons

Only certified HORIBA Medical technicians have access to the Technician Menu. The button will be grayed out for any other user.

Miniclean: launches a short rinsing cycle of the counting chambers.

Concentrated Cleaning: starts a concentrated cleaning procedure using ABX Minoclair.

2.7. Settings Menu Buttons

AutoClean: launches a cleaning cycle using ABX Cleaner.

Rules: allows to define rules for printing, sending to host and for rerun conditions.

Super User Menu: gives access to customer maintenance.

System: allows to set various system options such as date and time or printer options.

Technician Menu: (reserved to technicians) gives access to advanced maintenance.

Save/Restore: allows to save and restore the software configuration.

Users: allows to define operator profiles. The head of the laboratory designates who the Super User is. Super User is made of three additional menus: ■ Mechanical System which allows the management of mechanical cycles. ■ Hydraulic System which allows the management of hydraulic cycles. ■ Others which facilitates certain maintenance procedures, and allows to force calibration coefficient values and RET parameters.

Daily Guide Ref: RAB290CEN

Type Parameter Setting: allows to configure the instrument according to the blood type run.

6

Software Overview Cycle Selection Button

Soft Parameters: allows to edit software options.

Quality Assurance: allows to define CV for calibration, QC and repeatability. The XB mode is also set here.

2.8. Cycle Selection Button CBC/DIFF/RET: allows you to choose the test you want to perform

To perform a RET analysis, you need to activate the RETIC box and then select RET by pressing CBC/DIFF/RET.

Daily Guide Ref: RAB290CEN

7

Start of Day To Check the Waste Container Level

3. Start of Day Check the alignment of the paper if the printer used is a tractor feed printer.

3.1. To Check the Waste Container Level

Press the ON/OFF switch.

1. Check the level of waste in the container. 2. If it needs to be emptied, refer to the Maintenance and Troubleshooting > Replacement Procedures > To Replace Reagents > To Replace the Waste Container chapter of the user manual. When disposing of waste, protective clothing must be worn (lab coat, gloves, eye protection, etc.). Follow your local and/or national guidelines for biohazard waste disposal. ■ At the beginning of each day, before startup, check if the waste container needs to be emptied. ■ During instrument operation, do not remove the reagent tubes and the liquid waste tube under any circumstance.

Waste must be handled according to your local and/or national regulations.

3.3. Starting the Instrument

3.3.1.

To Switch the Instrument On

1. Switch the instrument on. 2. Wait during initialization. 3. Log in to the application. Refer to the Start of Day > Starting the Instrument > To Log In to the Application chapter.

3.3.2.

To Log In to the Application

3.2. To Switch the Printer On 1. Select a user name. 2. Enter your password. Make sure that the printer has enough paper for daily operations. If not, add some paper following the instructions of the printer user guide.

Daily Guide Ref: RAB290CEN

3. (Optional) Select Disable Auto Loader if you want to work in STAT mode only.

8

Start of Day Starting the Instrument

4. Select the following options: ■ Erase Worklist ■ Reset AutoNumbering ■ Archive Reports This step can only be performed when you start the instrument for the first time of the day. The first two options are optional, depending on your laboratory's rate of analysis. It is highly recommended to select the third option at the first startup of each day.

3.3.4.

Instrument Startup

Startup is used to control the analyzer before running analysis. It can be launched manually, or automatically depending on the application settings.

3.3.4.1. To Perform a Manual Startup Access: Main Menu > StartUp

5. Press OK.

1. Press StartUp.

3.3.3.

2. Select which cycle you want to perform:

To Control the Reagents Access: Main Menu > Status

The system can manage HORIBA Medical reagents automatically (levels and expiration date). It informs the user about the reagents status at the end of the instrument start, or displays an alarm message in the Status screen if a reagent runs low or has expired. However, it is recommended to check the reagent levels and expiration date before starting the system. To do so, you need to: 1. Check the level of the reagent bottles from the software.

2. Visually check the lot number and expiration date on the reagent bottles. 3. If a reagent bottle has to be changed, refer to the Maintenance and Troubleshooting > Replacement Procedures > To Replace Reagents chapter of the user manual.

Daily Guide Ref: RAB290CEN

A RETIC BLANK CYCLE must be performed before the first RET analysis of each day. 3. Wait until the cycle is over. Either cycle takes about 3 minutes 30 seconds. Blank cycles (cycles without any blood specimen) are performed during the startup cycle. The startup passes if the background counts are within acceptable limits: Parameter

Background count limits

WBC

≤ 0.3 x 103/mm3

RBC

≤ 0.03 x 106/mm3

HGB

≤ 0.3 g/dL

PLT

≤ 7 x 103/mm3

9

Start of Day Starting the Instrument

Parameter

Background count limits

LMNE

< 0.30#

RET

< 300#

Results of the startup are saved and can be consulted in the Blank Cycle logs. It is possible to run analyses after a failed startup cycle but a "Startup Failed" message is displayed on the following cycles. Refer to the Maintenance and Troubleshooting > Troubleshooting Procedures > Operation Problems > Startup Failed chapter of the user manual for more information.

If the system is not used for a period superior to 36 hours, it is mandatory to power it down. This eliminates startup problems, as well as the possibility of the dilution chambers evaporating.

3.3.4.2. To Schedule an Automatic Startup Access: Main Menu > Settings > System > Cycle Option

When you schedule an Automatic Startup, it is run as soon as connections with the instrument and reagents level have been checked. 1. Press Edit in the contextual toolbar. 2. In the StartUp area, select Automatic. 3. In the Begin the day area, specify the startup time.

4. Press Validate in the contextual toolbar. Results of the startup are saved and can be consulted in the Blank Cycle logs.

Daily Guide Ref: RAB290CEN

10

Running Quality Control Blood To Run a Control Blood in Rack Mode

4. Running Quality Control Blood 4.2. To Run a Control Blood in STAT Mode ■ Before analyzing any patient blood samples, it is recommended to perform quality control analysis on three levels of control blood material (low, normal and high) to make sure that the instrument is performing within the specified ranges of the quality control material. ■ Check control status in the Quality Control tab. If necessary, create a control. Refer to the Quality assurance > Quality Control chapter of the user manual.

It is recommended to run control bloods daily to check the performance of the instrument. Make sure you created the control lot before running it so that it is not run like a blood sample. RET controls can only be run in STAT mode. To run a control blood in STAT mode, you need to:

4.1. To Run a Control Blood in Rack Mode

1. Prepare your control blood according to the specific instructions detailed in the control blood leaflet (temperature, mixing, etc.). 2. Press STAT Mode to open the tube holder door. 3. Enter the lot number either manually or using the external barcode reader.

It is recommended to run control bloods daily to check the performance of the instrument. Make sure you created the control lot before running it so that it is not run like a blood sample. RET controls can only be run in STAT mode. To run a control blood in Rack mode, you need to: 1. Prepare your control blood according to the specific instructions detailed in the control blood leaflet (temperature, mixing, etc.). 2. Place the tube on a rack. Make sure that the barcode label is visible for the internal barcode reader. 3. Place the rack on the rack loader. 4. Press Start Rack.

4. Press Validate in the contextual toolbar. 5. Gently mix the control blood. 6. Put the tube in the tube holder and close the door to start sampling. When placing your tube in the tube holder, make sure that you are using the appropriate position and that the cap can be pierced. If not, remove the cap before closing the door. 7. When the door opens, remove the tube from the tube holder and recap it if needed. When the analysis is complete, the QC results are automatically saved in Quality Assurance > Quality Control.

When the analysis is complete, the QC results are automatically saved in Quality Assurance > Quality Control.

Daily Guide Ref: RAB290CEN

11

Running Quality Control Blood To Check Control Blood Results

4.3. To Check Control Blood Results Access: Main Menu > Quality Assurance > Quality Control

1. Select a control lot. 2. Press Detail in the contextual toolbar. 3. Check that the results are within control target values range. 4. If results are out of range, perform a concentrated cleaning and rerun the control blood. Refer to the Maintenance and Troubleshooting > Maintenance > Hydraulic Maintenance > To Perform a Concentrated Cleaning chapter of the user manual. If results are still out of range, please contact your local HORIBA Medical representative.

Daily Guide Ref: RAB290CEN

12

Worklist To Create a New Order in Grid View

5. Worklist 3. Select the test to perform by pressing CBC/DIFF/RET.

5.1. To Create a New Order in Grid View

To perform a RET analysis, you need to activate the RETIC box and then select RET by pressing CBC/DIFF/RET.

Access: Main Menu > Worklist

1. Press Insert in the contextual toolbar. 2. Enter all the information related to the blood sample and to the patient.

If you do not select the test that needs to be performed, the default test will be performed. 4. Press Validate in the contextual toolbar.

5.2. To Create a New Order in Rack View Access: Main Menu > Worklist

1. Press Rack View to display the rack view. 2. Enter the rack number using the external barcode reader. 3. Select an empty position to enter a new sample tube. If the tube position is not empty, both sample and patient information is displayed.

Daily Guide Ref: RAB290CEN

13

Worklist To Search Orders

4. Enter all the information related to the blood sample and to the patient.

5.3. To Search Orders

5.3.1.

To Search a Sample Access: Main Menu > Worklist

From the worklist, you can look for a specific sample record. To do so, you need to: 1. Press Insert in the contextual toolbar. 2. Press Search Sample. 3. Type the first characters of the sample ID in Sample ID. 4. When you have located the right sample, select it and press Validate.

5.3.2.

To Search a Patient Name

5. Select the test to perform by pressing CBC/DIFF/RET. Access: Main Menu > Worklist

You cannot create an order for a RET analysis in Rack mode.

From the worklist, you can look for a specific patient file. To do so, you need to: 1. Press Insert in the contextual toolbar. 2. Press Search Patient.

If you do not select the test that needs to be performed, the default test will be performed.

3. Type the first letters of the patient name in Patient Name. 4. When you have located the right sample, select it and press Validate.

6. Press Validate in the contextual toolbar. The cursor automatically moves to the next rack position. If there is no more position available for the current rack, the cursor moves to the next rack number.

Daily Guide Ref: RAB290CEN

14

Running Blood Specimen To Run the Specimen in Rack Mode

6. Running Blood Specimen 6.2. To Run the Specimen in STAT Mode 6.1. To Run the Specimen in Rack Mode Access: Main Menu > Worklist

RET analyses can only be performed in STAT mode.

Access: Main Menu > Worklist

RET analyses can only be performed in STAT mode. A Startup RET cycle is automatically performed before the first RET analysis of the day. A blood specimen can be run either in Rack mode or in STAT mode. To run it in STAT mode, you need to:

A blood specimen can be run either in Rack mode or in STAT mode. To run it in Rack mode, you need to:

1. Press STAT Mode to open the tube holder door.

1. Prepare your worklist.

3. Select the test to perform by pressing CBC/DIFF/RET.

2. If you work with tubes with barcode labels, place the tube on any rack, at any position. Make sure that the barcode label is visible for the internal barcode reader. 3. If you work with tubes with no barcode labels, place the tube on the rack and at the position specified in the worklist. 4. Place the rack on the rack loader.

2. Enter information about the sample.

If you do not select the test that needs to be performed, the default test will be performed. 4. Press CDR if you need a post-dilution on the sample.

5. Press Start Rack. The STAT mode can be used while analyses in Rack mode are already running. In this case, the analyses on the rack tubes are paused, and the STAT specimen is run in priority. It is not possible to use the CDR mode on RET samples.

Daily Guide Ref: RAB290CEN

15

Running Blood Specimen To Run the Specimen in STAT Mode

5. Select the appropriate dilution ratio for WBC/LMNE and for RBC/PLT/HGB.

6. Press Validate in the contextual toolbar. 7. Gently mix the blood specimen. 8. Put the tube in the tube holder and close the door to start sampling. When placing your tube in the tube holder, make sure that you are using the appropriate position and that the cap can be pierced. If not, remove the cap before closing the door. A bargraph is displayed in the status bar so that you can see the progress of the analysis. 9. When the door opens, remove the tube from the tube holder and recap it if needed. The STAT mode can be used while analyses in Rack mode are already running. In this case, the analyses on the rack tubes are paused, and the STAT specimen is run in priority.

The software automatically leaves the STAT Mode screen after 10 minutes of inactivity. If a pop-up window is displayed at the time, the software cannot leave the screen. Make sure you treat software required actions as soon as possible to prevent such a problem.

Daily Guide Ref: RAB290CEN

16

Results Matching Sample Identification

7. Results Matching You can also validate results that are not associated to an order. In this case, they will be matched to the default order (default test).

7.1. Sample Identification A sample can be identified in one of two ways: ■ through Barcode identification ■ through Rack/Position identification Identifying a sample is what allows the instrument to automatically match an order to a sample, or the operator to manually match an order to a sample.

7.2. To Manually Match Results Access: Main Menu > Reports > Match View

To match results and orders, you need to: 1. Select an unmatched order in the top area. 2. Select an unmatched result in the bottom area. 3. Press Validate in the contextual toolbar. A pop-up window prompts you to confirm. 4. Press OK. The order and the result are matched and can now be consulted in the Reports List. If the sample type is different for the order and the result, the result will be recomputed. It will be flagged in the Remarks field.

Daily Guide Ref: RAB290CEN

17

Results Management To Filter Results

8. Results Management RET results are automatically validated and cannot be customized or edited in any way.

8.1. To Filter Results 1. Select the result you want to customize to open the Report Details screen. Access: Main Menu > Reports

In the Report List, you can filter the results in order to display only the results you need. To do so, you need to: 1. Select one of the following options: ■ Unvalidated ■ Rejected ■ Validated and Transmitted ■ Validated but not Transmitted ■ Waiting for examination 2. Select the results you want to review.

8.2. To Customize Results

2. Review the results of each run using the left or right arrows. Compare the values of each run to the history values (if available). 3. Select or deselect the groups of parameters you want to show or hide for each run to create a composite report. The composite result is displayed in the Reports area. If a parameter group including alarms is selected, these alarms are associated to the composite result. 4. If you want to replace individual values manually, press Edit in the contextual toolbar to display the Report Edit screen. 5. Replace the values that need to be replaced. 6. Deselect Waiting for Examination after reviewing the result. 7. Press Validate in the contextual toolbar.

8.3. To Validate Multiple Results

Access: Main Menu > Reports Access: Main Menu > Reports

You can customize unvalidated results to: ■ ■ ■ ■

hide groups of parameters (RBC, PLT, WBC or DIFF), replace individual values manually, add comments about the patient, the sample or suspected pathologies, create a composite of the different runs of a sample.

Daily Guide Ref: RAB290CEN

Unvalidated results can be manually validated. To do so, you need to: 1. Select Unvalidated. 2. Select the results you want to validate.

18

Results Management To Validate a Single Result

3. Press Validate selected reports.

8.5. To Reject Multiple Results Access: Main Menu > Reports

A pop-up window prompts you to confirm. 4. Press OK.

Unvalidated results can be manually rejected. To do so, you need to: 1. Select Unvalidated.

Selected results are validated.

2. Select the results you want to reject. 3. Press Reject selected reports.

8.4. To Validate a Single Result A pop-up window prompts you to confirm. Access: Main Menu > Reports

Unvalidated results can be manually validated. To do so, you need to:

4. Press OK. Selected results are rejected.

1. Select Unvalidated. 2. Click the result you want to validate to open the Report View screen. 3. Press Validate selected reports.

8.6. To Reject a Single Result Access: Main Menu > Reports

4. Press OK. The selected result is validated.

Unvalidated results can be manually rejected. To do so, you need to: 1. Select Unvalidated. 2. Click the result you want to reject to open the Report View screen. 3. Press Reject selected reports.

A pop-up window prompts you to confirm.

Daily Guide Ref: RAB290CEN

19

Results Management To Rerun a Sample Manually

4. Press OK.

2. Press Print/Send in the contextual toolbar.

The selected result is rejected.

8.7. To Rerun a Sample Manually Access: Main Menu > Reports

3. Select one of the following options: ■ Print report list for selected rows ■ Print compact report list for selected rows ■ Print report list for all rows ■ Print compact report list for all rows ■ Print report in full page for selected rows ■ Print report in full page for all rows ■ Print the last report in full page ■ Print the run + raws in full page for selected rows 4. Press OK.

You cannot rerun a sample if it has no matched results.

You can rerun a sample manually. To do so, you need to:

You can only print the raw counts if the option has been enabled in Main Menu > Settings. Refer to the Settings > System > Printer Tab > To Enable Specific Data Printing chapter of the user manual for more information.

1. Select the result of the sample you want to rerun to open the Report View screen. 2. Press Rerun.

8.9. To Send Results to the LIS A pop-up window prompts you to confirm. 3. Press OK.

Access: Main Menu > Reports

A new order is created in the worklist.

8.8. To Print your Results Access: Main Menu > Reports

1. Select the results you want to print.

Daily Guide Ref: RAB290CEN

After each analysis cycle, validated results are automatically sent to the LIS if the option has been enabled. Refer to the Settings > Rules > Print/Transmit Conditions Tab > To Configure Transmit Conditions chapter of the user manual for more information. 1. Select the results you want to send to the LIS. 2. Press Print/Send in the contextual toolbar. 3. Select the Send tab.

20

Results Management To Send Results to the LIS

4. Select one of the following options: ■ Send the last report ■ Send the Selected Reports ■ Send all the Reports 5. Press OK.

Daily Guide Ref: RAB290CEN

21

Results Interpretation General Alarms

9. Results Interpretation Results that exceed the Panic limits are identified with an alarm:

9.1. General Alarms

■ L for results below the panic lower limit ■ H for results above the panic upper limit If an L alarm or an H alarm is triggered, you must be particularly careful when analyzing the results. Make sure you check the anteriority of the patient and rerun the sample if there is no clinical specificity.

9.1.1.

Parameter Reject

Reject flags occur whenever the difference between the two counts of a parameter is higher than the predefined limits. They indicate that the results for the flagged parameters are inconclusive, and that they should be investigated for the manual rerun status, and/or an instrument malfunction if the flag occurs on every sample. Rejected results are followed by an "*". Samples which trigger a reject cannot be validated and should be rerun.

9.1.2.

Results Exceeding Linearity Range and Visible Range

Parameter

Linearity Limits

Visible Range

> Visible Range

WBC

result

"result+D" displayed and printed "result+O" transmitted to the LIS* "result+X" transmitted to the LIS**

"--- D" displayed and printed "--- O" transmitted to the LIS* "--- X" transmitted to the LIS**

Suspicion

Results are followed by an "!" when the analyzer detects a possible anomaly during the count. The sample must be rerun.

9.1.3.

9.1.4.

LYM, MON, NEU, EOS, BASO, ALY and LIC replaced by "---" RBC

Normal and Panic Ranges

Results that exceed the Normal limits are identified with an alarm: ■ l for results below the normal lower limit ■ h for results above the normal upper limit

Daily Guide Ref: RAB290CEN

result

"result+D" displayed and printed "result+O" transmitted to the LIS* "result+X" transmitted to the LIS**

"--- D" displayed and printed "--- O" transmitted to the LIS* "--- X" transmitted to the LIS**

MCV, MCH, MCHC and RDW replaced by "---" *:

ABX format ASTM format ***: "Platelet Concentrate Mode" is displayed and printed when HGB < 2g/dL and PLT > 15 x 103/mm3 **:

22

Results Interpretation General Alarms

Parameter

Linearity Limits

Visible Range

> Visible Range

HGB

result

"result+D" displayed and printed "result+O" transmitted to the LIS* "result+X" transmitted to the LIS**

"--- D" displayed and printed "--- O" transmitted to the LIS* "--- X" transmitted to the LIS**

MCH and MCHC replaced by "---" HCT

result

"result+D" displayed and printed "result+O" transmitted to the LIS* "result+X" transmitted to the LIS**

"--- D" displayed and printed "--- O" transmitted to the LIS* "--- X" transmitted to the LIS**

MCH and MCHC replaced by "---" PLT

result

"result+D" displayed and printed*** "result+O" transmitted to the LIS* "result+X" transmitted to the LIS**

"--- D" displayed and printed*** "--- O" transmitted to the LIS* "--- X" transmitted to the LIS**

MPV, PCT and PDW replaced by "---" RET%

result

"result+D" displayed and printed "result+O" transmitted to the LIS* "result+X" transmitted to the LIS**

"--- D" displayed and printed "--- O" transmitted to the LIS* "--- X" transmitted to the LIS**

CDR Mode Parameter

Dilution Ratio Value

Dilution Ratio Value Visible Range

WBC

"value+D" displayed and printed "value+O" transmitted to the LIS* "value+X" transmitted to the LIS**

"--- D" displayed and printed "--- O" transmitted to the LIS* "--- X" transmitted to the LIS**

RBC

"value+D" displayed and printed "value+O" transmitted to the LIS* "value+X" transmitted to the LIS**

"--- D" displayed and printed "--- O" transmitted to the LIS* "--- X" transmitted to the LIS**

HGB

"value+D" displayed and printed "value+O" transmitted to the LIS* "value+X" transmitted to the LIS**

"--- D" displayed and printed "--- O" transmitted to the LIS* "--- X" transmitted to the LIS**

HCT

"value+D" displayed and printed "value+O" transmitted to the LIS* "value+X" transmitted to the LIS**

"--- D" displayed and printed "--- O" transmitted to the LIS* "--- X" transmitted to the LIS**

PLT

"value+D" displayed and printed "value+O" transmitted to the LIS* "value+X" transmitted to the LIS**

"--- D" displayed and printed "--- O" transmitted to the LIS* "--- X" transmitted to the LIS**

*: **:

ABX format ASTM format

It is not possible to use the CDR mode on RET samples.

*:

ABX format ASTM format ***: "Platelet Concentrate Mode" is displayed and printed when HGB < 2g/dL and PLT > 15 x 103/mm3 **:

Daily Guide Ref: RAB290CEN

Use ABX Diluent to dilute the sample when a "--- D" alarm occurs on a parameter.

23

Results Interpretation Morphology Alarms

9.2. Morphology Alarms

9.2.2.

Platelet Alarms

9.2.2.1. MICP Alarm

9.2.1.

This alarm indicates the presence of microcytes in the platelets counting area. If associated with a PLT reject "*", PLT results are not reliable.

RBC Alarms

RBC1 and RBC2 thresholds define the microcytic and macrocytic thresholds. They are calculated according to the MCV and the RDW. Microcytes are RBCs located before the RBC1 threshold and macrocytes are RBCs located after the RBC2 threshold. Microcytes values for Standard type are 5%, and Macrocytes values for Standard type are 45%. Flags are generated when results go beyond these values. Flag

Triggering conditions

MIC

MIC% > 5%

MIC+

MIC% > 10%

MIC++

MIC% > 15%

MAC

45 < MAC% LYM# H or if LYM% > LYM% H

Lymphopenia

LYM# < LYM# L or if LYM% < LYM% L

Neutrophilia

NEU# > NEU# H or if NEU% > NEU% H

Neutropenia

NEU# < NEU# L or if NEU% < NEU% L

Eosinophilia

EOS# > EOS# H or if EOS% > EOS% H

Myelemia

NEU% > NEU% H and LIC# > LIC# H

LIC

LIC# > LIC# H or if LIC% > LIC% H

ALY

ALY# > ALY# H or if ALY% > ALY% H

Left Shift

(MN or NL) and RN

Monocytosis

MON# > MON# H or if MON% > MON% H

Basophilia

BAS# > BAS# H or if BAS% > BAS% H

Pancytopenia

WBC < WBC L and RBC < RBC L and PLT < PLT L

Blasts

BAS# > BAS# H and LIC# > LIC# H and RM

WBC Interpretation Not Possible WBC < 0.1x103/mm3 or WBC > 85.0x103/mm3 or CO alarm

Daily Guide Ref: RAB290CEN

29

Results Interpretation Suspected Pathologies

9.3.2.

RBC Messages

Message

Triggered if...

Anemia

HGB < HGB L

Anisocytosis

RDW > RDW H

Microcytes

MIC Alarm

Microcytes+

MIC% > 10%

Microcytes++

MIC% > 15%

Macrocytes

MAC Alarm

Hypochromia

MCHC < MCHC l

Cold Agglutinin

MCHC > MCHC H and WBC < 91.3x103/mm3

Microcytosis

MCV < MCV L

Macrocytosis

MCV > MCV H

Erythrocytosis

RBC > RBC H

RBC Interpretation Not Possible RBC < 0.01x106/mm3 or RBC reject (or RBC > 0.03 during Startup)

Message

Triggered if...

Platelet Aggregates

Condition 1: ■ ■ ■ ■ ■ ■ ■ ■ ■

PLT < 150x103/mm3 + WBC reject, or NO + PDW > 20, or NO + MPV > 10, or NO + PLT < 150x103/mm3, or NO + WBC reject, or (L1 or LL1) + PDW > 20, or (L1 or LL1) + MPV > 10, or (L1 or LL1) + PLT < 150x103/mm3, or PDW > 20 + PLT < 120x103/mm3 (in CBC mode only, a suspicion "!" is triggered on PLT)

Condition 2:

NRBCs

■ ■ ■

LL, or WBC reject + L1, or WBC reject + LL1

Platelet Aggregates NRBCs

If conditions 1 and 2 are not satisfied and if L1 or LL1 or WBC reject

Macroplatelets

MPV > 11

PLT Interpretation Not Possible PLT < 5.0x103/mm3 or PLT reject (or SCL alarm during Startup)

9.3.3.

PLT Messages 9.3.4.

RET Messages

Message

Triggered if...

Thrombocytosis

PLT > PLT H

Thrombocytopenia

PLT < PLT L

Message

Triggered if...

Microcytosis

MICP Alarm

Reticulocytosis

RET# > RET# H and RET% > RET% H

Schizocytes

No threshold between RBC and PLT on the curves.

Reticulopenia

RET# < RET# L and RET% < RET% L

Small cells

Small cells at the beginning of the platelet curve.

Daily Guide Ref: RAB290CEN

30

Results Interpretation Analyzer Alarms

9.4. Analyzer Alarms

9.4.1.

NO Alarm

More about the NO alarm in the Results Interpretation > Morphology Alarms > LMNE Alarms chapter.

9.4.2.

MB Alarm

Meaning

Monocytes / Basophils

Conditions

The percentage of basophils found in the basophil channel is above the percentage of Lympho / Mono / Neutro raw counts found on the matrix channel.

Possible triggers

■ Small basophils in the ALY area ■ Blasts ■ Contamination of the basophil channel

CO Alarm

Meaning

Poor correlation

Conditions

The percentage of validated cells is abnormally low: correlation between resistive and optical measurements is < 50%

9.4.3.

9.4.4.

BASO+ Alarm

Conditions

The BASO+ alarm occurs on DIFF mode only. BAS% > 50%

Consequences

The basophils are not taken away from the matrix populations, and BAS% and BAS# are replaced by "---"

Daily Guide Ref: RAB290CEN

9.4.5.

WBC / LMNE / BAS Balance

If the difference between the LMNE and WBC / BAS counts is higher than the defined threshold, depending on the quantity of cells measured, a LMNE+ or a LMNE- alarm is generated.

9.4.6.

RBC / RET Balance

If the difference between the two counts is higher than the defined threshold, a BALANCE_RET+ or a BALANCE_RET- alarm is generated.

31

Results Interpretation Statistical Function Alarms

9.4.7.

Reticulocyte Alarms

You can:

Alarm

Triggered if...

Consequence

LOW_COUNT

Number of counted particles on the RET matrix < 10000 (absolute value)

"!" on all the reticulocyte parameters

LASER

Laser power output different from the one specified on your instrument

All the reticulocyte parameters are replaced by "----"

■ set the QC Failed alarm as a blocking alarm (refer to the Settings > Soft Parameters > General Tab > To Set Blocking Alarms chapter of the user manual for more information), ■ ensure the QC Failed alarm appears when you print results (refer to the Settings > Soft Parameters > General Tab > To Set Blocking Alarms chapter of the user manual for more information).

RBC alarms can also be triggered in RET mode. They are linked to the RBC morphology.

9.6. Delta Check 9.5. Statistical Function Alarms

9.5.1.

XB Alarm

The XB alarm is associated with patient quality control. It is triggered when: ■ the XB alarm is enabled (refer to the Settings > Quality Assurance > To Configure the XB Alarm chapter of the user manual for more information), ■ one of the mean values in a batch of 20 samples is outside the limits (refer to the Quality Assurance > Patient Quality Control (XB) > To Modify XB Limits chapter of the user manual for more information).

9.6.1.

Delta Check Overview

When you run an analysis, the delta check function checks the history of the patient (when available) and compares the values of the previous analyses to those of the current analysis for each parameter. The delta check is the coefficient of variation between the previous analyses and the current one. There are two different values for the delta check: ■ the absolute delta check, ■ the relative delta check.

An XB alarm can stop the instrument if you have set it as a blocking alarm (refer to the Settings > Soft Parameters > General Tab > To Set Blocking Alarms chapter of the user manual for more information).

9.6.2. 9.5.2.

QC Failed

The QC Failed alarm is triggered when the quality control results are out of range.

Daily Guide Ref: RAB290CEN

Absolute Delta Check

The absolute delta check refers to the absolute difference between the current analysis and the previous analyses. D = current value - history value

32

Results Interpretation Delta Check

The absolute delta check is then compared to the absolute delta check set by the operator (refer to the Settings > Rules > Delta Check Tab > To Change the Absolute Variation chapter for more information). ■ If D > absolute value defined by the operator and D > 0, Dabs+ is generated. ■ If D > absolute value defined by the operator and D < 0, Dabs- is generated.

9.6.3.

■ You can disable the Delta Check function if you have no use for it. Refer to the Settings > Rules > Delta Check Tab > To Enable or Disable the Delta Check Flag chapter of the user manual. ■ You can change the history validity period of the delta check if you want to. Refer to the Settings > Rules > Delta Check Tab > To Change the History Validity Period chapter of the user manual.

Relative Delta Check

The relative delta check refers to the relative difference between the current analysis and the previous analyses. D% =

current value - history value

X 100

current value + history value / 2

The relative delta check is then compared to the relative delta check set by the operator (refer to the Settings > Rules > Delta Check Tab > To Change the Relative Variation chapter for more information). ■ If D% > relative value defined by the operator and D% > 0, D%+ is generated. ■ If D% > relative value defined by the operator and D% < 0, D%- is generated.

9.6.4.

Delta Check Status

Two Delta Check alarms can appear in your results: ■ the Delta Check + alarm, ■ the Delta Check - alarm. The Delta Check + alarm appears when Dabs+ and D%+ have been triggered. The Delta Check - alarm appears when Dabs- and D%- have been triggered.

Daily Guide Ref: RAB290CEN

33

Archives To View Archived Results

10. Archives 10.2. To View Exported Results 10.1. To View Archived Results Access: Main Menu > Archive

1. To view archived results by date, you need to: a. Select the date you want to see the results of. b. Click the results you want to view to open the Report Details screen. c. Press Return to go back to the result list.

Access: Main Menu > Archive

You need to export results either on an FTP site or to an external media before you can view exported results. To view exported results, you need to: 1. Press Review Exported Reports.

2. To view archived results by patient, you need to: a. Press Reports by Patient.

b. Select the patient ID you want. You can also press Search Patient to look for a specific patient. Press Validate after you find the patient. c. Use the up and down scrollbar to see all parameters. Rejected results display crossed out parameters. d. Use the left and right scrollbar to see all runs for the patient. e. Click the results you want to view to open the Report Details screen. f. Press Return to go back to the result list.

2. Select: ■ Floppy Disk to view results from a floppy disk (if your instrument is equipped with a floppy drive) ■ USB Disk to view results from a USB key ■ NetWork to view results from the Host 3. Insert your floppy disk or your USB key if you chose one of the first two options. 4. Press OK.

10.3. To Print Archived Results Access: Main Menu > Archive

1. Select the results you want to print. 2. Press Print/Send in the contextual toolbar.

Daily Guide Ref: RAB290CEN

34

Archives To Send Archived Results to the LIS

3. For results by date, select one of the following options: ■ Print selected reports from list ■ Print compact daily report list for selected rows ■ Print all reports from list ■ Print compact daily report list for all rows

3. For results by date, select one of the following options: ■ Selected ■ All 4. Press OK.

4. For results by patient, select Print the patient reports? 5. Press OK.

10.4. To Send Archived Results to the LIS Access: Main Menu > Archive

1. Select the results you want to send to the LIS. 2. Press Print/Send in the contextual toolbar. 3. Select the Send tab. 4. For results by date, select one of the following options: ■ Send Selected Results ■ Send All Results 5. Press OK.

10.5. To Delete Archived Results Access: Main Menu > Archive

1. Select the results you want to delete. 2. Press Delete in the contextual toolbar.

Daily Guide Ref: RAB290CEN

35

End of Day Statistics

11. End of Day Statistics do not include RET analyses.

11.1. Statistics Access: Main Menu > Status

11.2. To Change Operator Access: Main Menu

You can log in as another operator without having to restart the instrument. To do so, you need to: 1. Double-click the second box of the footer. Beside the status of the reagents and the status of the racks, the Status menu also provides statistics for the current day, as well as overall statistics for the instrument. These statistics cover different aspects: ■ ■ ■ ■ ■ ■ ■ ■ ■

Percentage of run results within normal ranges Percentage of run results out of the normal range Percentage of run results out of the panic range Percentage of CBC runs Percentage of DIFF runs Percentage of reruns Number of Startup cycles Number of Shutdown cycles Number of Autoclean cycles

Daily Guide Ref: RAB290CEN

You are automatically logged-out. To log back in with your current user name, you need to reenter your password. 2. Log in with a new user account as described in Workflow > Start of Day > Starting the Instrument > To Log In to the Application chapter.

36

End of Day Stopping the Instrument

11.3. Stopping the Instrument

3. Specify the shutdown time.

11.3.1. To Perform a Manual Shutdown

11.3.3. To Switch the Instrument Off

Access: Main Menu > ShutDown

1. Press ShutDown.

4. Press Validate in the contextual toolbar.

It is highly recommended to perform a shutdown cycle before switching off the instrument. 1. Press Quit in the contextual toolbar.

2. Wait during the shutdown cycle.

2. Wait while the instrument shuts down. When the instrument is ready to be switched off, the following message appears on your screen: "It's now safe to turn off your computer." 3. Switch off the instrument.

If the system is not used for a period superior to 36 hours, it is mandatory to power it down. This eliminates startup problems, as well as the possibility of the dilution chambers evaporating.

11.3.4. To Switch the Printer Off 1. Make sure that no printout has been launched.

11.3.2. To Schedule an Automatic Shutdown

2. Switch the printer off.

Access: Main Menu > Settings > System > Cycle Option

In automatic shutdown mode, the shutdown is launched automatically every day at a predefined hour. Both Instrument and printer must be switched on 24 hours a day. 1. Press Edit in the contextual toolbar. 2. In the ShutDown area, select Automatic.

Daily Guide Ref: RAB290CEN

37

End of Day Stopping the Instrument

Daily Guide Ref: RAB290CEN

38