CELL-DYN 1700/1800 Software Training Simulation

The Abbott CELL-DYN® System is distributed by Abbott Laboratories, USA, Abbott Park, IL 60064 Document Control Number Revision Date Content or Pages Revised, Added, or Deleted 201908-101 Oct, 2005 New Release ©Copyright 2005 Abbott Laboratories CELL-DYN is a registered trademark of Abbott Laboratories. Any product information in this document should be used in conjunction with the latest version of the Operations Manual and Service and Support Manual. If any discrepancies in information exist within this document or any other, the latest version of the Operations Manual and/or Service and Support Manual takes precedence. All samples (printouts, graphics, displays or screens, etc.) are for information and illustration purposes only and shall not be used for clinical or maintenance evaluations.

INTRODUCTION The CELL-DYN 1700/1800 Software* Training Simulator is designed to provide a “realistic” experience of navigating within the analyzers software menus. *NOTE: The simulated software version presented is not an exact replica of the software found on the CELL-DYN 1000 series instruments but is a representation for training purposes only. The Software Simulation begins on Page 6. NAVIGATION TIPS: To navigate through the simulation use the active links outlined in red. The MAIN soft key returns to the Main Menu. The RETURN soft key returns to the Submenu from which the soft key was accessed. Not all soft key function is available in this simulation. Use this button to return to the indicated menu screen. Page numbers are for documentation purposes only and not for navigation. RECOMMENDATION: For the optimal training simulation experience, Do NOT use your keyboard to navigate through the software simulation. Use the links or follow the navigation information displayed on the screen.

OBJECTIVES Identify the Main Software Menus Practice Software Navigation

SOFTWARE OVERVIEW The operator uses Soft Keys located below the display to navigate through the analyzers system software. Pressing one of the 8 Soft Keys allows the operator to access the displayed menu. The Main Menu items are: SETUP PRIME/RUN DATA LOG QUALITY CONTROL CALIBRATION DIAGNOSTICS HELP/ERROR SPECIAL PROTOCOLS After accessing a Main Menu, submenus both for operator and service personnel use will be displayed.

Standby If STANDBY or INITIALIZED is displayed in the MAIN MENU Status Box, the Operator presses [PRIME/RUN] to bring the instrument to the READY state. Click the PRIME/RUN soft key. For the purposes of this simulation the HELP/ERROR menu is only available in the DIAGNOSTICS menu. The HELP/ERROR menu is available to the operator on every screen, and returns to the screen from which it was accessed.

Click the screen to Continue. Initializing Click the screen to Continue.

Run

Main Menu

Special Protocols Note: SPECIAL PROTOCOLS menu is the primary menu used during maintenance procedures. The MORE key displays a new menu and new soft keys that allow the Operator to perform additional procedures.

Auto Clean Note: AUTO CLEAN is used to flush and clean the entire fluidics system with enzyme solution.

Please press to return to Special Protocols Menu. Autoclean #2 The instrument cycles through the Auto Clean procedure and returns to Special Protocols. Please press to return to Special Protocols Menu. Continue

Daily Shutdown Return to Special Protocols Menu Note: DAILY SHUTDOWN is used to prepare the instrument for short periods of inactivity. Return to Special Protocols Menu Go to Special Protocols Standby Screen

Special Protocols Stand-By Return to Special Protocols Menu

Lyse Prime Return to Special Protocols Menu

Reagent Prime Return to Special Protocols Menu

Special Protocols More

Clean Sample Syringe

Clean Sample Syringe #2

Restore Sample Syringe Return to Special Protocols Menu More

Clean Diluent Syringe #1

Clean Diluent Syringe #2

Clean Diluent Syringe #3

Restore Diluent Syringe Return to Special Protocols Menu More

Clean Lyse Syringe #1

Clean Lyse Syringe #2

Restore Lyse Syringe #3 Return to Special Protocols Menu More

Probe Home

Probe Home #2 Return to Special Protocols Menu More

Drain Baths

Refill Baths Return to Special Protocols Menu More

Special Protocols More #2

1/50 Dilution Dispense

1/50 Dilution Dispense – Dispensing Screen Return to Special Protocols Menu More #2

1/250 Dilution Dispense

1/250 Dilution Dispense - Dispensing Screen Return to Special Protocols Menu More #2

10 mL Dispense

10 mL Dispense - Dispensing Screen Return to Special Protocols Menu More #2

Clean for Ship - Part 1 of Instruction

Clean for Ship - Part 2 of Instruction

Clean for Ship - Part 3 of Instruction

Clean for Ship - Complete To continue the simulation press . Note: The Operator must turn the instrument OFF using the power switch located on the side of the instrument. To return the instrument to an operational state the operator must first turn the power switch back ON. Continue

Diagnostics Menu To view the simulated DOS prompt please press . Note: Diagnostics enable the Operator or service representative to obtain information and execute programs that assist in troubleshooting. The MORE key displays a new menu and new soft keys that allow the Operator to perform additional diagnostics. The DOS prompt is accessed from Diagnostics by pressing ESC on the analyzer keyboard. Go to DOS

To DOS Prompt Return to Diagnostics Menu Note: When this screen appears, press [ALT] and [X] on the analyzer keyboard to get to the DOS prompt. The DOS Prompt program is not available in this simulation.

Raw Data Return to Diagnostics Menu Note: The Raw Measurement data for the last specimen analyzed is displayed.

Press SMOOTHING OFF to gain access to the simulated histogram screens. More Diagnostics Return to Diagnostics Menu For simulation purposes only the histogram keys are not active on this slide Press SMOOTHING OFF to gain access to the simulated histogram screens. Note: The smoothing key toggles between SMOOTHING OFF and SMOOTHING ON. This key is used to change the histogram display status. When smoothing is OFF and a histogram key is pressed, a raw data histogram data is shown.

More Diagnostics (#2)

More Diagnostics (#3)

Help/Error

Fault Log

System Status Note: SYSTEM STATUS displays or prints the current alarm status of the system.

Fault Report Note: Whenever the message Not Ready:See Diagnostics is displayed in the System Status Box, it is directing the operator to go to the DIAGNOSTICS menu and press the FAULT REPORT key and review or print the current fault status.

Service Hex Codes Return to More Diagnostics #3

Service Dec Codes Return to More Diagnostics #3

Probe Up Note: PROBE UP is used to check the up and down motion of the probe mechanism. When pressed, this key is highlighted and changes to PROBE DOWN.

Probe Down

Probe Home Note: PROBE HOME is used to check the homing operation of the probe mechanism. When pressed, this key is highlighted and changes to PROBE DOWN.

More Diagnostics (Smoothing ON) Note: The smoothing key toggles between SMOOTHING OFF and SMOOTHING ON. This key is used to change the histogram display status. When smoothing is ON and a histogram key is pressed, normalized and threshold-edited histogram data is shown along with the number of the peak channel.

WBC Histogram Note: The WBC Histogram is used to display the lysate-modified white cell count (numeric) data accumulated in each of 256 size channels. Each line contains data for 16 channels.

RBC Histogram Note: The RBC Histogram is used to display the red blood cell count (numeric) data accumulated in each of 256 size channels. Each line contains data for 16 channels.

Platelet Histogram Note: The Platelet Histogram is used to display the platelet count (numeric) data accumulated in each of 256 size channels. Each line contains data for 16 channels.

Calibration To access Dilution Factors in this simulation please press Note:When operating the analyzer, the Dilution Factors menu is accessed by pressing [9] [4] [0] [4] [3] on the analyzer keyboard.

Press PRE-DILUTE again to return to Calibration Menu. Note: The Pre-Dilute Calibration Method prepares the CELL-DYN® System to accurately measure pre-diluted samples. Refer to the CELL-DYN Operator’s Manual for additional information.

Auto-Cal Select Note: Auto-Cal is an automatic calibration program incorporated in the software. There are three methods under Auto-Cal: Calibrator, Fresh Whole Blood and MPV Latex (polystyrene).

Calibration Saved Return to Calibration submenu

Calibrator Calibration To begin the simulated calibration procedure, please press . Continue

Calibrator Calibration (cont.) Return to start of Calibrator Calibration To continue the calibration simulation press . Note: The analyzer operator uses arrow keys to place the cursor on the first parameter to be calibrated. Then to select a parameter for calibration presses the ENTER key to toggle from NO to YES. The operator then enters the reference value from the enclosed calibrator insert, without decimals. Continue

Calibrator Calibration (cont.) Return to start of Calibrator Calibration To continue the calibration simulation press . Note: The analyzer operator will press ENTER on the analyzer keyboard to toggle to YES and then enter the value from the calibrator insert, without decimals, for each parameter being calibrated. Continue

Calibrator Calibration (cont.) Return to start of Calibrator Calibration To continue the calibration simulation press . Note: The operator will press ENTER on the analyzer keyboard to toggle to YES and then enter the value from the calibrator insert, without decimals, for each parameter being calibrated. Continue

Calibrator Calibration (cont.) Return to start of Calibrator Calibration To continue the calibration simulation press . Note: The analyzer operator will press ENTER on the analyzer keyboard to toggle to YES and then enter the value from the calibrator insert, without decimals, for each parameter being calibrated. Continue

Calibrator Calibration (cont.) Return to start of Calibrator Calibration To continue calibration simulation press . Note: When READY is displayed on the screen, the operator will run the calibration material from the calibration screen. Continue

Calibrator Calibration (cont.) To continue with calibration simulation press . Note: Values from Run 1 are displayed. The operator will mix the calibration material and continue to run in the current screen. Continue

Calibrator Calibration (cont.) Return to start of Calibrator Calibration To continue with the calibration simulation press . Note: Values from Run 1 and 2 are displayed. The operator will mix the calibration material and continue to run in the current screen Continue

Calibration Complete To simulate saving the calibration press the RETURN soft key highlighted with red box. Note: After three successful runs, the Factor and Mean Factor for each parameter to be calibrated are calculated by the system.

Whole Blood Calibration Note: Calibration with fresh whole blood samples is an alternative to calibration with a commercial calibrator. Refer to the CELL-DYN® Operator’s Manual for additional information.

MPV Calibration Note: This procedure is performed by an authorized Abbott representative. Refer to the CELL-DYN® Operator’s Manual for additional information.

Whole Blood Factors

Dilution Factors

Enter Factors Note: Enter Factor is an alternative to Auto-Cal that allows the Operator to manually enter calibration factors. The Enter Factor Method may be preferred when calibrating with whole blood samples. Refer to the CELL-DYN® Operator’s Manual for additional information. RESTORE FACTORS – will restore the previous calibration factors RESET ALL TO 1.00 – will reset the factors to factory setting of 1.00 Restore Factors and Reset All to 1.00 are not active during this simulation.

Quality Control For the purposes of this simulation, only the X-B and Replicates menus are available. Note: The Quality Control Menu provides access to the files for each level of control: Low, Normal, and High. Prior to running a control specimen the Operator selects the file for inclusion. Each time a QC specimen is run, the mean, standard deviation, and coefficient of variation for each parameter are calculated and updated automatically in each file.

X-B Data Note: The X-B File is used to display and print data and graphs for the red blood cell indices: MCV, MCH, and MCHC, including the date and time for each batch. The X-B algorithm provides a means of utilizing this information for quality control purposes. Refer to the CELL-DYN® Operator’s Manual for additional information.

X-B Graphs

Replicate File Note: Replicate files contain specific specimen records that were selected for inclusion in a particular replicate file prior to running those specimens To select a file the Operator uses the arrow keys to highlight the file prior to running the specimen. Replicate file Selection is not available in this simulation.

Page up and down is not available in this simulation. Replicate File #1 To observe a simulated Left or Right Scroll through the parameters press: Page up and down is not available in this simulation. Note: When accessing a Replicate or QC File on the analyzer the Operator can page Up or Down to view additional pages. Left and Right arrows are used to scroll through the complete list of parameters for all specimens displayed on a page.

Replicate File #1 (cont.) To continue simulated scroll through the parameters press: Other soft key function is not available on this screen simulation. Return to start of Replicate File #1

Replicate File #1 (cont.) To continue simulated scroll through the parameters press: Other soft key function is not available on this screen simulation Return to start of Replicate File #1

Replicate File #1(cont.) To continue simulated scroll through the parameters press: Other soft key function is not available on this screen simulation Return to start of Replicate File #1

Replicate File #1 (cont.) To continue simulated scroll through the parameters press: Other soft key function is not available on this screen simulation Return to start of Replicate File #1

Levey-Jennings WBC Note: When a control or replicate file has been selected, the Operator can display and print Levey-Jennings graphs. The file name is shown on the upper left of the screen. Print functions are not available in this simulation.

Levey-Jennings RBC

Reject Specimen Return to Replicate File #1 Note: The Operator can accept, reject, or delete the specimen indicated by the flashing cursor. When a specimen has been rejected an “R” is placed after the sequence # field and the specimen is removed from statistical calculation. If the same specimen is accepted, the “R” is removed and the specimen is included in the statistical calculations.

Purge QC Log Note: When a control or replicate file has been selected (file name is shown on the upper left of the screen), the Operator can purge data from the file. Pressing CONFIRM PURGE completes the purge. Pressing CANCEL PURGE cancels the purge. Once CONFIRM PURGE is pressed, data in the file is permanently erased. Confirm Purge is not available in this simulation.

Delete File Note: The Operator can accept, reject, or delete the specimen indicated by the flashing cursor. When a specimen has been rejected an “R” is placed after the sequence # field and the specimen is removed from statistical calculation. Pressing CONFIRM DELETE will complete the deletion and pressing CANCEL DELETE will cancel the deletion. Deleted specimens are not included in statistical calculations. Confirm Delete is not available in this simulation.

Data Log Note: When accessing the Data Log on the analyzer the Operator can use the Up and Down or the Left and Right arrows to scroll through and view data on the active screen. This feature is not available within this simulation.

Display Specimen

Previous Specimen

Next Specimen

Find Specimen Return to Data Log To observe a simulation of the response that occurs upon entering data for #48, as shown here on this slide, press . Note: On this screen the Operator types in a Sequence Number and then presses [ENTER] to display data. Continue

Find Specimen

Find Specimen

Transmit Data Return to Data Log Note: On this screen the Operator Enters a Start Sequence and End Sequence Number, then presses the [ENTER] key to transmit the data to their LIS.

Confirm Transmit

Print Data Log Return to Data Log Note: On this screen the Operator Enters a Start Sequence and End Sequence Number, then presses the [ENTER] key to print a Data Log section.

Setup

Reagent Log

Diluent Log

Detergent Log

Lyse Log

Date/Time Setup

Patient Limits

Help/Error

Fault Log

Patient Limits 2

Panic Limits

QC Setup

High Control File selection is not available in this simulation. Note: The Operator selects the file to setup by highlighting it using the arrow keys on the analyzer keyboard. File selection is not available in this simulation.

High Control File Setup

High Control Range Entry

Load from Disk

High Control Mean Entry

Load From Disk

Low Control File selection is not available in this simulation. Note: The Operator selects the file to setup by highlighting it using the arrow keys on the analyzer keyboard. File selection is not available in this simulation.

Low Control File Setup

Low Control Range Entry

Load From Disk

Low Control Mean/Limits

Load From Disk

X-B Setup

Lab ID Setup

Normal Control File selection is not available in this simulation. Note: The Operator selects the file to setup by highlighting it using the arrow keys on the analyzer keyboard. File selection is not available in this simulation.

Normal Control File Setup

Normal Control Range Entry

Load From Disk

Normal Control Means/Limits

Load From Disk

Replicate File File selection is not available in this simulation. Note: The Operator selects the file to setup by highlighting it using the arrow keys on the analyzer keyboard. File selection is not available in this simulation.

Replicate File Setup

Replicate File Range Entry

Replicate File Means/Limits

Computer Setup

Units Selection

Specimen Type

Normal Background Note: The selected Specimen Type is listed in the upper left of the screen.

Electrical Background Note: The selected Specimen Type is listed in the upper left of the screen.

QC Type

Low Control File selection is not available in this simulation. Note: The Operator selects the file to place the specimen in by highlighting it, then presses RETURN to return to the Run Screen. The selected File Name will be shown in the Left corner of the Run Screen. File selection is not available in this simulation.

Low Control Run Note: The selected Specimen Type and file is listed in the upper left of the screen.

Normal Control File selection is not available in this simulation. Note: The Operator selects the file to place the specimen in by highlighting it, then presses RETURN to return to the Run Screen. The selected File Name will be shown in the Left corner of the Run Screen. File selection is not available in this simulation.

Normal Control Run Note: The selected Specimen Type and file is listed in the upper left of the screen.

High Control File selection is not available in this simulation. Note: The Operator selects the file to place the specimen in by highlighting it, then presses RETURN to return to the Run Screen. The selected File Name will be shown in the Left corner of the Run Screen. File selection is not available in this simulation.

High Control Run Note: The selected Specimen Type and file is listed in the upper left of the screen.

Replicate File File selection is not available in this simulation. Note: The Operator selects the file to place the specimen in by highlighting it, then presses RETURN to return to the Run Screen. The selected File Name will be shown in the Left corner of the Run Screen. File selection is not available in this simulation.

Replicate Specimen Run Note: The selected Specimen Type and file is listed in the upper left of the screen.

Parameter Set

SUMMARY In this training program you were familiarized with: The Software Menu Structure of a CELL-DYN 1700/1800 analyzer Software Navigation