CELL-DYN Sapphire TM Interface Set-up Procedure for Accelerator DM Application Software Version 1.0

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1 Abbott Accelerator TM Decision Manager TM Page 1 of 20 CELL-DYN Sapphire TM Interface Set-up Procedure for Accelerator DM Application Software Version 1.0 Purpose Prepare the Accelerator Decision Manager system to communicate with one or more CELL-DYN Sapphire TM systems Module Version 1.0 Accelerator Decision Manager system software and CELL-DYN Sapphire TM Interface Driver Disk, LN 09H09-01 Tools and Materials 1. Accelerator V. 1.0 CELL-DYN Sapphire TM Interface Driver Disk, LN 09H Interface cables: PN depends on needed length. 3. CELL-DYN Sapphire TM Graphics Kit: LN 09H Optional: ISA for Digi Acceleport Xp TM Installation 5. Optional: ISA for Digi One SP installation Estimated Time Procedure: o Instrument configuration 60 min. o ADM system configuration 60 min. Total: 120 min. Important Assumptions: This procedure is based on the assumption that the server and any client hardware with corresponding operating systems have been installed and configured by an Abbott representative and that necessary interfacing hardware such as Digi Acceleport Xp TM or Digi One SP have been installed. Data Hardware connection NOTE: Use only cables provided by Abbott or cables that match Abbott specifications. 1. Verify the cable connections are secure to the ADM workstation network hub, COM port, or Digi Acceleport Xp TM, as applicable. 2. Connect the RS-232 connector to COM3 on the back of the SCC that controls the CELL-DYN Sapphire. o Digi One SP: ISA o Digi Acceleport Xp TM : ISA Graphics Hardware connection NOTE: Use only cables provided by Abbott or cables that match Abbott specifications. 1. Verify the cable connections are secure to the ADM network hub, COM port, or Digi Acceleport Xp TM, as applicable. o ATEN Converter Manual

2 Abbott Accelerator TM Decision Manager TM Page 2 of Shutdown the CELL-DYN SCC and the ADM Workstation that will be connected. 3. Connect the LPT Printer cable to the LPT1 port (directly on the motherboard) on the back of the SCC that controls the CELL-DYN Sapphire. 4. Use the ATEN SXP320A Converter to convert the Parallel to Serial port. 5. Configure the ATEN converter using the DIP switches. Configure the switches as follows (for detailed information on each switch, refer to the User s Manual supplied with the converter): 6. Make the connection as diagrammed below.

3 Abbott Accelerator TM Decision Manager TM Page 3 of 20 If connecting through the network via Digi One SP s, connect as follows: 7. Restart the Workstation PC and the Cell-Dyn SCC. 8. Verify the Workstation PC COM port settings for the Graphics port as the following (Control Panel System Hardware Tab Device Manager Ports): o Baud Rate = o Parity = None o Data Bits = 8 o Stop Bits = 1 o Flow Control = Hardware o Select OK when done, and close all windows. CELL-DYN Sapphire TM Driver Installation Instrument host configuration for Data Load the analyzer driver to the PC Workstation according to the Analyzer Driver Installation document. 1. See CELL-DYN Sapphire TM System Laboratory Information System Interface Specification Document for steps to access other Host interface settings and procedures to reset the SCC once changes are made. Analyzer Driver Installation Procedure for ADM: CELL-DYN Sapphire TM System Laboratory Information System Interface Specification, 08H09-01A (March, 2005)

4 Abbott Accelerator TM Decision Manager TM Page 4 of Click on SETUP on the left side of the SCC main menu. 3. Select LIS/AUTOTRANSMIT from menu. The following window will appear Activate Enable Auto-Transmit to transmit results from the CELL-DYN Sapphire SCC to the ADM. Note: The Auto-Transmit/Hold Criteria are defaulted to Hold, which prevents transmission of records that contain results with: Limit Set Violations, Suspect population flags, Invalid Data, or Failed Delta Check. Verify with the site to determine which, if any, of these flags will be transmitted automatically. 5. Activate Enable Work List Download automatically accept Work List entries from the LIS. 6. Enable Host Query by Specimen ID to query the LIS once the Bar Code Reader reads the Specimen ID. 7. Click on the Communication Setup The following window will appear. 8. Enter the appropriate parameters as follows: o Baud Rate = 9600 o Parity = None o Data Bits = 8 o Stop Bits = 1 o Select OK when done. 9. Select the OK button in the LIS/Auto-transmit Setup window to save the changes.

5 Abbott Accelerator TM Decision Manager TM Page 5 of 20 Instrument host configuration for Graphics 1. Restart the CELL-DYN Sapphire. 2. Login as o Username: admin o Password: syssetup 3. When the menu Sapphire Admin Utilities is displayed, select the Config menu and then select Set Printer Devices. Two printers will appear. o Printer A corresponds to the Graphics Printer. o Printer B corresponds to the Data/Ticket Printer. 4. Select Printer A (Graphics). 5. Choose the Generic PDF driver. 6. Click OK. Then, click Exit. 7. Click Exit Utility to exit the printer device configuration. 8. Login as a regular user: o User: cd o Password: cd or EMPTY 9. Click on the Setup button on the left of the main console screen.

6 Abbott Accelerator TM Decision Manager TM Page 6 of Click Print to configure the Graphics printer Click on the Graphics Report to configure the graphics printer settings. 12. Select Autoprint Graphics Report. 13. Under On Demand Print from Data Log, select Laboratory as the Graphics Report. 14. Click Autoprint to configure the auto print settings. 15. Select the Color setting to send the graphics in color. 16. In the section Laboratory Worksheet (to the right), check Always. 17. Click OK to exit the Autoprint Setup. Click OK to exit the Print Setup. Install the new screen layout 1. Browse the Cell-Dyn Sapphire Driver disk. 2. Proceed to the Abbott folder. 3. Copy the AbbottScreensBackup.exe file into C:\Program Files\PGP\L_MV5\Bin directory. 4. Run the AbbottScreensBackup.exe file from the Bin directory.

7 Abbott Accelerator TM Decision Manager TM Page 7 of Click on the Restore button. 6. Click on Restore All Screens (From File). 7. In the file selection dialog box, move up one directory, select the Data directory, and open the ANA- 002E4B95.txt file. 8. A success message will appear to indicate that the screen layout for the Cell-Dyn Sapphire graphics has been updated. 9. Click OK. Close the Abbott Screens Backup utility.

8 Abbott Accelerator TM Decision Manager TM Page 8 of 20 Test PDF Decoding 1. Start Gaia, if not started. 2. Double-click on the Ariane icon for the Cell-Dyn Sapphire. 3. Select Connection Log Explore File Exchange directory. This will open the folder for graphics files. The folder should be empty. Keep the folder open. 4. Return to Ariane, and select Connection Log Import File to Exchange directory. 5. Proceed to C:\Program Files\PGP\L_MV5\Data and select the ANA-002E4B95.pdf file.

9 Abbott Accelerator TM Decision Manager TM Page 9 of The file will appear briefly in the exchange directory, but will be replaced by 6 bmp files. 7. Minimize Ariane. 8. Open ADM. Select the result list for the Sapphire. 9. The result list will contain one record 4594MOD. Open the record to verify that the graphics are present. 10. Close ADM. Install PDF Archiving (optional) This option will allow the system to archive the PDF instead of deleting the files. 1. Open Ogmios Equipment Analyzers Analyzers. 2. Select the Cell-Dyn Sapphire installed. 3. Proceed to the Files tab, and then select the Options tab.

10 Abbott Accelerator TM Decision Manager TM Page 10 of Scroll down to the [Files] section and locate the ArchiveRoot= entry. 5. Enter a directory name (i.e. C:\PdfArchive_Sapphire2\) Note: Ensure that there is a \ (backslash) at the end of the directory. 6. Click OK. 7. Restart the Ariane associated with the Sapphire. 8. Check to make sure that the directory has been created. 9. Repeat the steps in the Test PDF Decoding section to verify the archival option. 10. The archive directory will now contain a PDF file with the name containing the specimen ID, date, and time. Note: When connecting multiple instruments on the same workstation, the archive directory can be shared by all of the instruments. The archive directory can be located on a network drive. Do not make the archive directory a subdirectory of the C:\Program Files\PGP\L_MV5\Transfer\CD4kGraph directory because the files in the directory will be deleted after 24 hours. Test PDF printing Note: The printing feature is only available if archiving has been activated. 1. Verify that a default printer is installed. 2. Verify that Adobe Acrobat Reader is installed and assigned to PDF files. 3. Double-click on the Ariane icon for the Sapphire.

11 Abbott Accelerator TM Decision Manager TM Page 11 of Select Option Automatic printout. This option will automatically generate a printout when Ariane receives graphics from the analyzer. 5. Repeat the steps in the Test PDF Decoding section to automatically print the PDF file. 6. The PDF file should be printed on the default printer. 7. Open Ariane again, and de-select Option Automatic printout. Install Printer Grabber Software to capture the Graphics 1. When connecting multiple hematology instruments to a workstation, assure that the input directories are separate for each instrument. 2. Go to Ogmios Equipment Analyzers Analyzers. Select the Sapphire installed and go to the Files tab. 3. Change the ReceiveRoot entry under the [Files] heading to indicate a specific directory. For example: 4. Click OK to continue. 5. Unzip the C:\Program Files\PGP\L_MV5\Data\ANA- 002E4B90.zip file. Ensure that the file is unzipped into the C:\Program Files\PGP\L_MV5\ directory. 6. Go to Ogmios Jobs Advanced Processes. 7. Select the PrtCapturer process, and click on Clone.

12 Abbott Accelerator TM Decision Manager TM Page 12 of Enter a unique name for the process (i.e. Sapphire_1_PrtCapt). 9. Click Save. The system will ask, Do you want to copy send/receive codes? Click on Yes. 10. Click on the Process tab. 11. Check Start automatically. 12. Check On a Single Workstation, and select the workstation connected to the Sapphire. 13. Click on the Properties tab. Scroll down to the System heading, and record the Id number. (ADM will associate the Print Capture process with the analyzer through the Id number). 14. Click on OK. 15. Perform a Stop-and-go on Gaia. This will generate the PrtCaptXXXXXXXX.ini file (where XXXXXXXX stands for the process ID number in hexadecimal format). Note: The process may fail to start if the serial port is already in use. This is typically the case on a server, where Janus uses the COM2 port.

13 Abbott Accelerator TM Decision Manager TM Page 13 of To determine the specific PrtCapt.ini file, perform the following steps: o Convert the Id obtained in step 13 to hexadecimal. o Open Calculator (Start Run type calc OK). o Go to View and change to Scientific. o Input the Id number. o Change the standard from Dec to Hex. The number will now be converted to hexadecimal. Record the hexadecimal number, and close Calculator. 17. In C:\Program Files\PGP\L_MV5\data\ directory, open the PrtCaptXXXXXXXX.ini file in Notepad. o Change the PortNumber to the graphics port (Enter 1 for COM1, 2 for COM2, etc.). o Change the BaudRate to o StartString: String that starts the graphics capture. Set the StartString=\37\80\68\70 o EndString: String that ends the graphics capture. Set the EndString=\37\69\79\70 o NameofOutputExtent: Extension of the captured graphics file. Set the NameofOutputExtent=.tmp o LastCharToAdd: Sometimes, the name of the captured file will end with a space. This causes problems when decompressing a PDF file. This will replace the last character in the file name. Set this option to F. o WorkFilePath: The location where the decoded files are stored. This must match the ReceiveRoot= specified in the analyzer initialization file (Ogmios Equipment Analyzers Analyzers). o Save and Close the file. The file should match the following:

14 Abbott Accelerator TM Decision Manager TM Page 14 of Perform a stop-and-go on Gaia. 19. The PrtCapturer process should appear in the system tray. Note: It is common for the first PDF file to be lost after the converter is just powered on or reset. Other ADM System Configuration 1. Go to Ogmios Equipment Analyzers Analyzers. Select the Sapphire installed and go to the Files tab. [Buffer] Input: Verify the value is (one million). [Files] KeepOld: Specifies the number of hours to keep the PDF files generated by the decoder. The default is 4. Note: If the Archive directory has been created, the PDF files will be automatically saved in the archive directory, and this setting will not be relevant. [Send] Filter o Query mode: set Filter = 2. o Non-query mode: set Filter = 1. General Configuration Procedure for ADM:

15 Abbott Accelerator TM Decision Manager TM Page 15 of 20 Refer to the General Configuration Procedure for other ADM configuration steps necessary to communicate with the CELL-DYN Sapphire TM system. Instrument Assay Codes Routine request from ADM to the CELL-DYN Sapphire TM Routine results transmission from CELL-DYN Sapphire TM to ADM QC Handling Re-transmitting one or more results/samples from CELL-DYN Sapphire TM to ADM Specimen Types Alarms The default instrument assay codes are preloaded with the driver. No worklist action is required before sample information can be queried and received by the analyzer from ADM. No operator action is required before sample data can be transmitted from the analyzer to ADM unless instrument operator prefers certain Host options so that results are released manually from the analyzer. No specific decoding is performed. 1. Click DataLog. 2. Select Record to resend. Note: It is possible to retransmit multiple records that are in numerical order; otherwise each record will have to be retransmitted individually. 3. Click View Record. 4. Click Transmit to resend the numerical results. 5. Click Print. 6. Click In Color to resend the graphics. Note: The graphics will not be on the same results screen as that of the data. Specimen types may not be supported by the specific LIS to which ADM is connected. However, for specific rules related to sample types, ADM may be configured to address these for each assay. There are two kinds of alarms: Those that the Sapphire sends and which are decoded. Those that are derived from the presence of the 'Warning'-flag on certain analyses defined by the manufacturer and that need to be customized for the particular installation. General Configuration Procedure for ADM:

16 Abbott Accelerator TM Decision Manager TM Page 16 of 20 There are different alarm types sent by the Cell-Dyn: Alarms corresponding to the Data Invalidation Flags have a receive code of "00" to "31". These are normally decoded as Comments On Run. These will be displayed on the measure with receive code "COMMENT DI." Alarms corresponding to Suspect Population Flags are decoded as values of the measure "COMMENT SP", again decoded as Comments On Run. They have a receive code corresponding to the first 16 characters of the name of the flag, for example: "Asymmetric RBC". The same receive code can be used by measures to allow recovery of the confidence index. Alarms corresponding to Delta Check Flags have a receive code of "NOMA", "FAIL" and "PASS". Accelerator TM Decision Manager TM will perform and apply the delta-checks. Alarms corresponding to the field Result Status of the results. Only "W" (Warning) flag is applicable with the analyzer. Alarms corresponding to the Result Abnormal Flags in the results have a code of 1 or 2 characters like "L" or "HH". Accelerator TM Decision Manager TM can determine the reference and panic ranges therefore they are not used. See appendix A for a list of applicable Alarms. For alarms calculated from the Flag Warning, the rules may vary slightly for each laboratory. Verification Note: Assure that all Ogmios configuration steps have been completed. Note: Also, assure that Ariane and the Print Capturer process are active on the workstation connected to the analyzer. 1. Obtain a barcode from the laboratory to use for the verification. Place the barcode on either a sample or normal QC sample. 2. Create an order for a CBC using the barcode provided by the customer. An order will now be created on the analyzer. 3. Place the sample on the analyzer and run the autoloader.

17 Abbott Accelerator TM Decision Manager TM Page 17 of Once the run is complete the data will be automatically sent to ADM. 5. Maximize Ariane and verify that the communication log contains data transmission. The log will look like the following: 6. Open ADM. Proceed to the Results screen for the analyzer and open the order. 7. Verify that the graphics accompany the numerical data. 8. If PDF Archiving has been activated, proceed to the archive directory established earlier (PrtCaptXXX.ini ReceiveRoot= entry). Verify that a PDF file has been generated in the directory.

18 Abbott Accelerator TM Decision Manager TM Page 18 of 20 Troubleshooting PGP-70126: Only NN found for RunCod XXXXXXXX This error message will occur when the decoder found a number of graphics on the page that is different from 6. This means that either one of the graphics was missed, or something that is not a graphic is recognized as one. PGP-70123: Unrecognized graph? XXXX/YYYY/ZZZZ This error message indicates that XX was recognized as a graphic name (i.e. Optical PLT), but that no matcher was found to uniquely identify the graphic type. YY and ZZ fields are texts in the PDF stream that are the vertical and horizontal axis labels. Registering New Graphics 1. Identify the graphic with a code. 2. Create or retrieve the corresponding measure definition in the database. Give it the chosen code as Receive Code. 3. Create a new section in the INI file. Give it the name GRAPHIC-LL-CCCC, where CCCC = chosen code and LL = the locale/language (EN, FR, IT, GE, and SP). 4. Fill the Code, Horizontal Axis, Vertical Axis, and Name of the section with the appropriate values. Note: It is possible that multiple combinations correspond to the same graphic code. For example, it is possible to define the code OPTPLT to refer to the graph named Optical PLT and also to the graph named Optical Platelets by having different recognizers: [GRAPHIC-EN-OPTPTL] Name=Optical PLT HorizontalAxis=... VerticalAxis=... Code=OPTPLT [GRAPHIC-EN-OPTPLT-1] Name=Optical Platelets HorizontalAxis=... VerticalAxis=... Code=OPTPLT

19 Abbott Accelerator TM Decision Manager TM Page 19 of 20 Appendix A: Sapphire Alarm Names and Codes Receive codes Short name Standard name Long Name 01 Impedance Aperture Clog Impedance Aperture Clog 03 Laser current Too High Laser current Too High 04 Hot Pot Temperature Error Hot Pot Temperature Error 05 Hot Pot Speed Error Hot Pot Speed Error 07 HGB Diluti Syrin Failed To Home HGB Diluti Syrin Failed To Home 08 Missing Reagent Tube Missing Reagent Tube 09 Incorrect Reagent Tube Incorrect Reagent Tube RBC Reagent Syrin Failed To Home RET Reagent Syrin Failed To Home WBC Reagent Syrin Failed To Home Pneumat Failure in High Pressure Pneumat Failure Medium Pressure Pneumat Failure in Low Pressure Pneumat Failure in Vacuum Range Aspirat Deposit Pump Fail ToHome RBC Reagent Syrin Failed To Home RET Reagent Syrin Failed To Home WBC Reagent Syrin Failed To Home Pneumat Failure in High Pressure Pneumat Failure Medium Pressure Pneumat Failure in Low Pressure Pneumat Failure in Vacuum Range Aspirat Deposit Pump Fail ToHome 18 Aspiration Probe Not Up Aspiration Probe Not Up 19 Insufficient Reticulo Reagent Insufficient Reticulo Reagent 20 VPM Communications Failure VPM Communications Failure 22 Insufficient sample Insufficient sample 23 RET Count Rate Error RET Count Rate Error 24 WBC Count Rate Error WBC Count Rate Error 25 RBCi Count Rate Error RBCi Count Rate Error 26 PLTi Count Rate Error PLTi Count Rate Error 27 PLTo Count Rate Error PLTo Count Rate Error 28 CD61 Opt PLT Stream Mismatch CD61 Opt PLT Stream Mismatch Flag Warning on Red Blood Cells Ric-Roc Delta Ric-Roc Delta Flag Warning on platelets Pic-Poc Delta Pic-Poc Delta Nonviable WBCs NWBC Nonviable WBCs Nonviable WBCs Bands Bands Bands Blasts Blasts Blasts Variant Lymphoid Variant Lymphoids Variant Lymphoids Immature Granulo Immature Granulocytes Immature Granulocytes

20 Abbott Accelerator TM Decision Manager TM Page 20 of 20 Unidentified Flu FP Unidentified Fluorescent Cells Unidentified Fluorescent Cells Resistant RBCs RRBC Resistant RBCs Resistant RBCs Asymmetric RBC Asym RBC Asymmetric RBC Asymmetric RBC High Number Imma IR Immature Retic Immature Retic Platelet Clumps Platelet Clumps Platelet Clumps W Warning Warning Flag Warning on at least 2 elements of the formula(%) Flag Warning on Eosinophiles %? Flag Warning on absolute Retics Flag Warning on Mean Platelet Volume Unable Find Clear Sep WBC SubPop Nb WBC event Greater than Limits Signific Nb Cell Remove WBC Diff Invalid Ret Pop or Too few Event Region Interference In Plt Histo Unable to Find Clear Separation between WBC SubPopulation Number of WBC events out of bounds Greater than preset Limits Significant Number of Cells Remove from WBC Differential Invalid Retic Population or Too few Events Region Interference In Platelet Histogram END OF DOCUMENT

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