INDEX TECHNICAL SERVICE BULLETIN

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1 CELL-DYN 3200/SL (109) Index ABBOTT ADD INDEX TECHNICAL SERVICE BULLETIN PRODUCT: CELL-DYN 3200/SL (109) DATE: 29-JUL-98 TSB # IMPLEMENTATION SUBJECT EFFECTIVITY DATE I - See TSB CELL-DYN 3200/SL Fan 22-JUL N - See TSB Revision C, Version 1.4 Software 06-JUL N - AF & below Revision B v1.3 Software Upgrade 10-JUN N - AF & below New Autoloader Mixer and Lifter Assemblies 10-JUN N - AF & below New Hemaglobin Flow Cell Assembly 15-MAY N - See TSB Block II Retrofit 01-JUL A I - See TSB RBC/PLT Threshold Setting 20-MAR I - See TSB RBC/PLT Threshold Setting CANCELLED

2 TSB# CELL-DYN 3200/SL Fan Page 6 ABBOTT ADD TECHNICAL SERVICE BULLETIN SUBJECT: TSB#: CELL-DYN 3200/SL Fan ORIGINATOR: Raymond Lopretto PRODUCT: APPROVED: David Bannister CELL-DYN 3200/SL (109) Trademark: CELL-DYN is a registered trademark of Abbott Laboratories REF. ECO: Dev.1449 IMPLEMENTATION: Immediate Next Service Call Next Failure Optional Instruments Requiring Modification: 60035AF and below TSB Part/Kit #: TSB Effectivity/ Part(s) Availability: 22-JUL-98 TSB Tracking by Serial # required (IMMEDIATE TSB's ONLY) YES NO Upgrade Time: 0.2 hr Validation Time: 0.2 hr Total Mod. Time: 0.4 hr **NOTE** The instrument must be at TSB Level n/a prior to performing this TSB. I. DISTRIBUTION: Worldwide. II. PURPOSE: To change the direction of the fan to increase cooling air flow and help HGB drift issues. III. ADMINISTRATIVE NOTES: Reversing the fan may cause a physical interference between the fan blades and the wire mesh filter on Block 2 CD3200. Remove the wire mesh filter and replace with a fan guard ( part number ) on Block 2 CD3200 and Block 2 Retrofitted CD3200. Any CD3200 still in Block 1 configuration does not need the guard replaced until TSB CD3200 Block 2 Retrofit has been completed. IV. SPECIAL TOOLS: This modification does not require any special tools.

3 TSB# CELL-DYN 3200/SL Fan Page 7 V. PARTS: Fan guard part number REPLACED PARTS: Do not return any parts. COMPATIBILITY: All CD3200 VI. PROCEDURE: MODIFICATION STEPS: 1. With the CD3200 powered off remove the left side cover to gain access to the fan assy ( see picture above ) Disconnect the power cord to the fan and remove the four screws mounting the fan assy to the frame. Once removed note that the arrow on the fan is pointing inward this is the the direction of the air flow. Now remove the four screws holding the fan to the fan mounting assy and reverse the fan, so that the arrow is now pointing outward. If the CD3200 is Block 2 release or Block 2 Retrofit replace the wire mesh with the fan guard (P/N# ).

4 TSB# CELL-DYN 3200/SL Fan Page 8 6. Remove fan filter to gain an additional increase in air flow Reinstall the fan assembly, and fan power cord then replace the left side cover. Power on the CD3200 and verify operation. CHECKOUT: Verify the direction of air flow is now flowing outward, and verify the operation of the CD3200 by running controls. MODIFICATION CONTROL STICKER UPDATE: Check box 10 on the Modification Control Sticker. END OF DOCUMENT

5 TSB# Revision C, Version 1.4 Software Page 9 ABBOTT ADD TECHNICAL SERVICE BULLETIN SUBJECT: TSB#: Revision C, Version 1.4 Software ORIGINATOR: Randy Lloyd PRODUCT: APPROVED: Dave Bannister 7/6/98 CELL-DYN 3200/SL Trademark: CELL-DYN is a registered trademark of Abbott Laboratories REF. ECO: IMPLEMENTATION: Immediate Next Service Call Next Failure Optional Instruments Requiring Modification: All Instruments using version 1.1 or above TSB Part/Kit #: 06H93-01 TSB Effectivity/ Part(s) Availability: 06-JUL-98 TSB Tracking by Serial # required (IMMEDIATE TSB's ONLY) YES NO Upgrade Time: 60 Min Validation Time: 10 Min Total Mod. Time: 70 Min **NOTE** The instrument must be at TSB Level n/a prior to performing this TSB. I. DISTRIBUTION: Hematology Field Service Worldwide, Hematology CSC, TSR's, Hardware Specialist, and HTSS's. II. PURPOSE: Revision C, Version 1.4 software is being released as a mandatory upgrade for all CD3200 instruments currently using Version 1.1 or above software. The previous version 1.3 is not necessary to upgrade to version 1.4. The Version 1.4 upgrade kit (06H93-01) will be distributed to all CD3200 customer sites. The kit includes complete instructions, and is designed to be installed by the customer. For detailed information about the changes and additions refer to the customer documentation attached to this TSB. The Version 1.4 upgrade kit includes the following: 1) Version 1.4 software diskettes 1 & 2 2) Letter to the customer 3) Upgrade Instructions

6 TSB# Revision C, Version 1.4 Software Page 10 4) Summary of Changes and additions (for Rev B, V1.3) 5) Summary of Changes and additions (for Rev C, V1.4) 6) Flagging Summary 7) Addendum to calibrator and control assay sheets III. ADMINISTRATIVE NOTES: The Version 1.4 upgrade includes important corrections and additions to be implemented on a next service call basis. Version 1.4 will be installed on all CD3200 instruments currently using version 1.1 or higher software. Because the previous version 1.3 upgrade was not sent to all CD3200 customers, all of the features of version 1.3 are also included in version 1.4. The summary of changes and additions for both versions are included in the version 1.4 kit. The version 1.4 upgrade kits will be delivered to all CD3200 customers sites. The kit includes installation instructions (attached) designed to guide the customer through performing the upgrade. It is recommended that FSRs follow up with all CD3200 customers on a next service call basis to insure that this important upgrade has been completed. The FSR should offer assistance with performing the upgrade if the customer has not already completed it. Important Note: After installing Version 1.4 software, the customer should then begin using the revised control and calibrator assay values that are given in the addendum enclosed in the customer kit, and attached to this TSB. FSRs are recommended to read the attached customer documents carefully.

7 TSB# Revision C, Version 1.4 Software Page 11 ABBOTT DIAGNOSTICS DIVISION CELL-DYN 3200 System June 1998 Software Upgrade, Revision C, v1.4 Upgrade Kit List Number 06H93-01 Dear CELL-DYN 3200 Customer, It is with great pleasure that I introduce Software Upgrade, Revision C, v1.4, for the CELL-DYN 3200 Hematology System. This software version is the result of Abbott Laboratories continued commitment to provide our valued hematology customers with the highest quality of products and services available. Software Upgrade, Revision C, v1.4, is an operation- and data-enhancement package that improves overall system operation. This package includes everything you need to install software Revision C, v1.4, on your CELL-DYN 3200 System(s). Installation Disks (#1 and #2) Summary of Changes and Additions (Revision B, v1.3 and Revision C, v1.4) NOTE: Software version 1.4 includes v1.3 and v1.4 changes. Installation Instructions Flagging Summary Addenda to CELL-DYN 3000 Calibrator and Control assay sheet. To complete this upgrade, you will need: The current CELL-DYN 3200 SET-UP Disk CELL-DYN 3000 Controls 3-5 normal patient samples approximately one hour of time for the system to install the new software The CELL-DYN 3200 system automatically installs the new software, but during this time is unable to run specimens or retrieve results. It is very important that the system is kept ON, except when directed otherwise by the software Installation Instructions. Inappropriate interruptions during the installation process may result in the loss of stored data. This software upgrade requires no hardware modification or assistance by Field Service. IMPORTANT NOTES: Software Upgrade Revision C, v1.4, is mandatory and must be installed on all systems, whether using Revision A, v1.1 or Revision B, v1.3. Changes have been made to WBC and RBC/PLT flagging, therefore all specimens run after the

8 TSB# Revision C, Version 1.4 Software Page 12 Revision C, v1.4 upgrade will be compared to this new flagging criteria. It is not necessary to return disks or other materials to Abbott Laboratories. As with other CELL-DYN products, many changes and improvements have come from customer feedback. Abbott Laboratories encourages customer input and remains committed to meeting your needs. If you have questions about Revision C, v1.4, please call the Abbott Customer Support Center at CELL-DYN ( ) in the U.S. International Customers, please contact your local Customer Support Representative. Thank you for your continued support of Abbott Laboratories and CELL-DYN products. Sincerely, Sherb Edmondson CELL-DYN 3200 System Hematology Product Manager

9 TSB# Revision C, Version 1.4 Software Page 13 ABBOTT DIAGNOSTICS DIVISION CELL-DYN 3200 System June 1998 Summary of Changes and Additions Software Upgrade Revision C, v1.4 Upgrade Kit List Number 06H93-01 The following is a summary of changes and additions contained within the Software Upgrade Revision C, v1.4, for the CELL-DYN 3200 Hematology System. Note: If you have any questions please contact the Customer Support Center, at CELL-DYN ( ) for U.S. Customers. For International Customers, please contact your local Customer Support Representative. System Upgrades: Changes to the QC flowscript reduce the WBC (WOC) bias on patient specimens when run as Patient Specimen Type rather than as QC Specimen Type. The Shear Valve Assembly can be automatically reset for normal operation after a cleaning by pressing RESTORE. There is no need to re-initialize the instrument before continuing operation. Sample mixing has been optimized to reduce the formation of bubbles in tubes during the mixing process. The in-line blood sensor now has enhanced air bubble detection capabilities. Samples run as FWBC Specimen Type use a new flowscript that yields improved WBC Differential information. Data Station Upgrades: The Worklist now accepts DOB entries beyond the first page; this was a limitation on the previous software version. Algorithm Upgrades: A WBC flag will occur when the WOC and NOC counts do not agree within predetermined

10 TSB# Revision C, Version 1.4 Software Page 14 limits; confirmation is required before reporting these results. Improvements have been made to FWBC flagging sensitivity. Other flagging changes are described in the Flagging Summary ( A) included in this upgrade kit.

11 TSB# Revision C, Version 1.4 Software Page 15 ABBOTT DIAGNOSTICS DIVISION CELL-DYN 3200 System June 1998 Installation Instructions Software Upgrade Revision C, v1.4 Upgrade Kit List Number 06H93-01 The following instructions take you step-by-step through the procedure for installing Software Upgrade Revision C, v1.4, which is mandatory for systems running Rev. A, v1.1 and Rev. B, v1.3. Note: If you have questions, please contact the Customer Support Center, at CELL-DYN ( ) for U.S. Customers. For International Customers, please contact your local Customer Support Representative. Required Items: CELL-DYN 3200 Revision C, v1.4 System Installation Disks #1 and #2 Current CELL-DYN 3200 SET-UP Disk ( ) 3 to 5 normal patient specimens Low-, normal- and high-level controls Approximately 1 hour to complete the installation Installation Procedure Preparation for installation: 1. Run and print the results for 3-5 normal patient specimens. 2. Run and print the results of the low-, normal- and high-level controls. 3. Verify control recovery with existing assay sheet. 4. Save patient specimens and controls to re-run after installation is completed. 5. Perform Daily Shutdown; when STANDBY appears in the Status Box, continue on to Backup of Current Calibration Factors and Operator-Selected Limits and Ranges. Backup of Current Calibration Factors and Operator-Selected Limits and Ranges This software upgrade will not affect calibration factors, results in the Calibration Log, QC Log, Worklist Log, Error Log, Maintenance Log, or any operator-selected items in the SETUP menu. Backing up this information is a safeguard against the rare event of a power failure during the upgrade installation process. Backing up assures recovery of current settings if a problem occurs. Note: Entries typed at the DOS prompts are not case sensitive.

12 TSB# Revision C, Version 1.4 Software Page With the MAIN MENU screen displayed, press the F12 key then the F8 key. The following message displays: CD3200 Program Terminated (0) C:\CD3200> 2. Insert the current CELL-DYN 3200 SET-UP Disk ( ) into the Instrument s Diskette Drive A (located on the right side-panel of the instrument). Press and hold the Ctrl and Alt keys, then press the Delete key on the keyboard; this resets the instrument s Data Station. 3. When the DOS prompt Select (A) Abort; (S) Save; (R) Restore: [A, S, R]? displays, type s (Save). The following files are saved. Nonvol QC Log Calibration Log Worklist Log Error Log Note: If the message Write Protect Error Writing Drive A displays, eject the SET-UP Disk. Unlock the disk by sliding the write-protect tab on the disk s corner. Reinsert the disk and press the R key on the keyboard. 4. When the following prompt displays, the backup is complete: A:\> 5. Remove the SET-UP Disk from the diskette drive and return it to the Diskette Box on the rear of the instrument. 6. Turn the instrument OFF. Installation of New System Software: Insert CELL-DYN 3200 Revision C, v1.4, System Installation Disk #1 into the diskette drive and turn the instrument power ON. Note: Disk #1 will install automatically. When instructed by the screen message, remove Disk #1. Insert CELL-DYN 3200 Revision C, v1.4, System Installation Disk #2 into the diskette drive and follow the screen instructions. The instructions describe configuring information for the CS [Closed Sampler] or SL [Sample Loader] models. Type Y to continue. When the following appears: Choose [a] Abort; [s] SL model; or [c] CS model [a, s, c], determine the appropriate system model and input [s] for the SL model or [c] for the CS model. Note: Selecting an incorrect system model will cause improper instrument operation.

13 TSB# Revision C, Version 1.4 Software Page 17 When C:\CD3200> appears on the screen, turn the instrument power OFF and remove Disk #2. Installation is now complete and the instrument can be initialized as described in the following section. Initializing the System: Turn ON the instrument power switch. Note: The initialization process may take 3-5 minutes. DO NOT turn the instrument power OFF during this process. After the system has initialized, run a background, rerun the 3-5 normal patient specimens, and the low-, normal- and high-level controls to verify recovery of results. Please refer to the attached Addendum for new target assigned values for the CELL-DYN 3000 Controls. After installation of version 1.4 software, use the updated assigned values in the addendum for confirmation of results. If you have questions regarding software, Revision C, v1.4, please call the Abbott Customer Support Center at CELL-DYN ( ). International Customers, please contact your local Customer Support Representative. Thank you for your continued support of Abbott Diagnostics and our CELL-DYN products. Sincerely, Sherb Edmondson CELL-DYN 3200 System Hematology Product Manager

14 TSB# Revision C, Version 1.4 Software Page 18 ABBOTT DIAGNOSTICS DIVISION CELL-DYN 3200 Software Revision C, v1.4 Flagging Summary June 1998 Upgrade Kit List Number 06H93-01 PATIENT SPECIMEN TYPE FLAG or DESCRIPTION WBC DFLT (NLMEB) RRBC/NRBC NWBC FWBC CRITERIA Declining WOC kinetic rate detected and more than 10% of WBC count in Region N1. Default thresholds were used for determining the 5-part Differential or declining WOC kinetic rate detected. Declining WOC kinetic rate detected and more than 2.9% WBC count in Region N1. More than 2.9% WBC Count in Region N1. Declining WOC kinetic rate detected and/or more than 15% Lymphs in RBC region. CAUSE & ACTION Unusual pathology suspected. Evaluate other suspect flags as directed in the Operator's Manual. Review smear. Confirm the WBC value by an alternate method, according to your lab protocol. Confirm Differential. Abnormal clusters or abnormally low number of cells. Review smear. If appropriate, and if no other suspect flags are displayed, report WBC and Differential. RRBC suspected to be present. Repeat specimen in RRBC Mode to eliminate RRBCs. NRBCs may also be present. Potentially significant number of NWBCs (non-wbcs) below the dynamic threshold on the 0/10 degree scatterplot. Review smear to determine cause of interference. Fragile WBC suspected. Repeat specimen in FWBC mode to obtain valid WBC count.

15 TSB# Revision C, Version 1.4 Software Page 19

16 TSB# Revision C, Version 1.4 Software Page 20 ABBOTT DIAGNOSTICS DIVISION CELL-DYN 3200 Software Revision C, v1.4 Flagging Summary June 1998 Upgrade Kit List Number 06H93-01 RRBC and FWBC SPECIMEN TYPES FLAG or DESCRIPTION WBC DFLT (NLMEB) CRITERIA NOC not equal to WOC and the delta exceeds expected limits and/or NOC/WOC data does not fit algorithm criteria. Default thresholds were used for determining the 5-part Differential or declining WOC kinetic rate detected. CAUSE & ACTION Unusual pathology. Evaluate other suspect flags as directed in the Operator's Manual. Review smear. Confirm the WBC value by an alternate method, according to your lab protocol. Confirm Differential. Abnormal clusters or abnormally low number of cells. Review smear. If appropriate, and if no other suspect flags are displayed, report WBC and Differential. NRBC NOC > WOC and N1 Region is > 2.9%. NRBCs suspected but do not interfere with the WOC. Refer to the LABORATORY WORKSHEET* screen to obtain estimate of NRBCs. Review smear. If appropriate, and if no other suspect flags are displayed, report WOC and Differential. RRBC WOC > NOC and NI Region is > 2.9%. RRBC suspected. If appropriate, and if no other flags are displayed, report WBC and Differential. NWBC NOC = WOC and N1 > 2.9% (WOC is the reported WBC). Potentially significant number of NWBCs (non-wbcs) below the dynamic threshold on the 0/10 degree scatterplot. Review smear to determine cause of interference. FWBC NOC > WOC. Fragile WBCs suspected. Review smear and confirm LYM value. If appropriate, and if no other suspect flags are displayed, report WBC and Differential.

17 TSB# Revision C, Version 1.4 Software Page 21 NOC NOC not equal to WOC and NOC was chosen for WBC count. If no other suspect flags are displayed, report WBC. WOC NOC not equal to WOC and WOC was chosen for WBC count. If no other suspect flags are displayed, report WBC. * For laboratory use only.

18 TSB# Revision C, Version 1.4 Software Page 22 ABBOTT DIAGNOSTICS DIVISION CELL-DYN 3200 Software Revision C, v1.4 Flagging Summary June 1998 Upgrade Kit List Number 06H93-01 PATIENT,RRBC, and FWBC SPECIMEN TYPES FLAG or DESCRIPTION BAND CRITERIA 1) Region % Estimate > 12.5% of total WBC. 2) Ratio of Bands/Neuts > 50%. 3) CV of Neut cluster on 0 deg axis exceeds expected limit. CAUSE & ACTION Bands suspected to be present. Review smear and follow lab review criteria. Refer to the LABORATORY WORKSHEET* screen for more information. IG Region % Estimate > 3% of total WBC. IGg IGs suspected to be present. Review smear and follow lab review criteria. Refer to the LABORATORY WORKSHEET* screen for more information. BLAST Region % Estimate > 1% of total WBC. Blasts suspected to be present. Review smear and follow lab review criteria. Refer to the LABORATORY WORKSHEET* screen for more information. Var Lym 1) Region % Estimate > 10% of total WBC. 2) Neut/Lym ratio falls below expected criteria. 3) Absolute Lymph or mononuclear count exceeds expected limits and Lymph / monocyte ratio exceeds expected criteria. Variant Lymphs suspected to be present. Review smear and follow lab review criteria. Refer to the LABORATORY WORKSHEET* screen for more information. * For laboratory use only.

19 TSB# Revision C, Version 1.4 Software Page 23 ABBOTT DIAGNOSTICS DIVISION CELL-DYN 3200 System June 1998 Addenda to CELL-DYN 3000 Calibrator Lot # CD3050 and CELL-DYN 3000 Tri-Level Hematology Control Lot # 0077 Target Assigned Values Dear CELL-DYN 3200 Customer, Attached are addenda to the CELL-DYN 3000 Calibrator Lot # CD3050 and CELL-DYN 3000 Tri-Level Hematology Control Lot # 0077 with new Target Assigned Values for CELL-DYN 3200 Systems using Software Revision C, v1.4. If you have questions about Revision C, v1.4, please call the Abbott Customer Support Center at CELL-DYN ( ) in the U.S. International Customers, please contact your local Customer Support Representative. Thank you for your continued support of Abbott Laboratories and CELL-DYN products. Sincerely, Sherb Edmondson CELL-DYN 3200 System Hematology Product Manager

20 TSB# Revision C, Version 1.4 Software Page 24 CELL-DYN 3000 Control Tri-Level Hematology Control FOR USE WITH REVISION C, v 1.4 SOFTWARE ONLY Experation Date 06 AUG Day Open-Vial Stabillity Abnormal Low Lot No. L0077 Instrument Parameter Assay Value Mean Range CELL-DYN 3200, WBC (WOC) K/µL 2.4 ± 0.3 NOC (WBC) K/µL 2.7 ± 0.3 NEU K/µL 1.6 ± 0.6 NEU % 67.1 ± 7.0 LYM K/µL 0.4 ± 0.6 LYM % 16.3 ± 7.0 MONO K/µL 0.2 ± 0.2 MONO % 9.5 ± 5.0 EOS K/µL 0.1 ± 0.1 EOS % 4.1 ± 3.0 BASO K/µL 0.1 ± 0.5 BASO % 3 ± 5.0 RBC M/µL 2.43 ± 0.15 HGB g/dl 6.5 ± 0.3

21 TSB# Revision C, Version 1.4 Software Page 25 HCT % 15.6 ± 1.5 MCV fl 64 ± 5.0 MCH pg 26.7 ± 2.0 MCHC g/dl 41.7 ± 3.0 RDW % 15.8 ± 3.0 PLT K/µL 66 ± 25.0 MPV fl 6.2 ± 2.0

22 TSB# Revision C, Version 1.4 Software Page 26 CELL-DYN 3000 Control Tri-Level Hematology Control FOR USE WITH REVISION C, v 1.4 SOFTWARE ONLY Experation Date 06 AUG Day Open-Vial Stabillity Normal Lot No. L0077 Instrument Parameter Assay Value Mean Range CELL-DYN 3200, WBC (WOC) K/µL 8.4 ± 0.6 NOC (WBC) K/µL 8.5 ± 0.6 NEU K/µL 5.2 ± 1.5 NEU % 61.6 ± 7.0 LYM K/µL 1.9 ± 0.8 LYM % 22.6 ± 10.0 MONO K/µL 0.8 ± 0.5 MONO % 9.5 ± 5.0 EOS K/µL 0.2 ± 0.2 EOS % 2.6 ± 3.0 BASO K/µL 0.3 ± 0.5 BASO % 3.7 ± 6.0 RBC M/µL 4.15 ± 0.18 HGB g/dl 13.1 ± 0.4

23 TSB# Revision C, Version 1.4 Software Page 27 HCT % 25.9 ± 2.5 MCV fl 62.5 ± 4.0 MCH pg 31.6 ± 2.0 MCHC g/dl 50.6 ± 3.0 RDW % 12.4 ± 3.2 PLT K/µL 215 ± 25.0 MPV fl 5.7 ± 2.0

24 TSB# Revision C, Version 1.4 Software Page 28 CELL-DYN 3000 Control Tri-Level Hematology Control FOR USE WITH REVISION C, v 1.4 SOFTWARE ONLY Experation Date 06 AUG Day Open-Vial Stabillity Abnormal High Lot No. L0077 Instrument Parameter Assay Value Mean Range CELL-DYN 3200, WBC (WOC) K/µL 17.4 ± 1.5 NOC (WBC) K/µL 17.7 ± 1.5 NEU K/µL 9.6 ± 1.8 NEU % 55.1 ± 7.0 LYM K/µL 4.2 ± 2.0 LYM % 24.4 ± 10.0 MONO K/µL 1.9 ± 0.6 MONO % 11.2 ± 5.0 EOS K/µL 0.5 ± 0.4 EOS % 2.7 ± 3.0 BASO K/µL 1.2 ± 0.9 BASO % 6.6 ± 7.0 RBC M/µL 4.68 ± 0.20 HGB g/dl 15.8 ± 0.5

25 TSB# Revision C, Version 1.4 Software Page 29 HCT % 30.2 ± 3.5 MCV fl 64.6 ± 4.0 MCH pg 33.8 ± 2.5 MCHC g/dl 52.3 ± 3.3 RDW % 12.1 ± 3.5 PLT K/µL 423 ± 45.0 MPV fl 5.8 ± 2.0

26 TSB# Revision C, Version 1.4 Software Page 30 CELL-DYN 3000 Calibrator A Whole Blood Calibrator for Use on CELL-DYN Hematology Systems FOR USE WITH REVISION C, v 1.4 SOFTWARE ONLY Lot No. CD3050 Expiration Date 06 AUG Day Open-Vial Stabillity Parameter CELL-DYN 3200 WBC K/µL 8.6 NOC K/uL 8.6 RBC M/µL 4.12 HGB g/dl 13.3 MCV fl 61.9 PLT K/µL 215 MPV fl N/A

27 TSB# Revision C, Version 1.4 Software Page 31 IV. SPECIAL TOOLS: Not Applicable V. PARTS: 06H93-01 Version 1.4 Software Upgrade Kit REPLACED PARTS: Not Applicable COMPATIBILITY: Version 1.4 Software is compatible with all CD3200 instruments currently using version 1.1 or higher software. VI. PROCEDURE: Refer to installation instructions attached. MODIFICATION STEPS: Not Applicable CHECKOUT: Refer to installation instructions attached. MODIFICATION CONTROL STICKER UPDATE: When the Rev C, V1.4 upgrade has been completed, mark the modification control sticker to reflect TSB 009. END OF DOCUMENT

28 TSB# Revision B v1.3 Software Upgrade Page 32 ABBOTT ADD TECHNICAL SERVICE BULLETIN SUBJECT: TSB#: Revision B v1.3 Software Upgrade ORIGINATOR: Randy Lloyd PRODUCT: APPROVED: David C. Bannister 6/3/98 CELL-DYN 3200/SL Trademark: CELL-DYN is a registered trademark of Abbott Laboratories REF. ECO: IMPLEMENTATION: Immediate Next Service Call Next Failure Optional Instruments Requiring Modification: SN 60006AF and below TSB Part/Kit #: 06H90-01 TSB Effectivity/ Part(s) Availability: 10-JUN-98 TSB Tracking by Serial # required (IMMEDIATE TSB's ONLY) YES NO Upgrade Time: 60 min Validation Time: 10 min Total Mod. Time: 70 min **NOTE** The instrument must be at TSB Level n/a prior to performing this TSB. I. DISTRIBUTION: Hematology Field Service Worldwide, Hematology CSC, TSR's, Hardware Specialist, and HTSS's. II. PURPOSE: Revision B (Version 1.3) software is being released as a mandatory upgrade for all CD3200 instruments currently using Rev A v1.1 software. The Rev B v1.3 upgrade kit (06H90-01) will be distributed to all CD3200 customer sites. The kit is designed to be installed by the customer. There will also be an optional international language package (06H91-01) to follow this release. For detailed information about the changes and additions refer to the customer documentation attached to this TSB. The Rev B v1.3 upgrade kit includes the following: A) Revision B software diskettes (1 & 2) B) Letter to the customer C) Upgrade Instructions D) Summary of Changes and additions

29 TSB# Revision B v1.3 Software Upgrade Page 33 F) Flagging Summary III. ADMINISTRATIVE NOTES: The Rev B v1.3 upgrade includes important corrections and additions to be implemented on a next service call basis. Rev B v1.3 will be installed on all CD3200 instruments currently using v1.1 software. The upgrade kits will be delivered to customers sites. The kit includes installation instructions (attached) designed to guide the customer through performing the upgrade. It is recommended that FSRs follow up on all CD3200 customers on a next service call basis to insure that the upgrade has been completed. The FSR should offer assistance with performing the upgrade if the customer has not already completed it. The international language kit (06H91-01) is an optional addition requiring V1.3 to be installed first. The international kit cannot be used on any previous software version. Languages included in the kit are: French, German, Italian, Spanish, and Japanese. The following is the Letter to the customer: ABBOTT DIAGNOSTICS CELL-DYN 3200 System May 1998 Software Upgrade, Revision B, v1.3 Upgrade Kit List Number: 06H90-01 Software Upgrade Dear CELL-DYN 3200 Customer, It is with great pleasure that I introduce Software Upgrade, Revision B v1.3, for the CELL-DYN 3200 Hematology System. This latest software version is the result of Abbott Laboratories continued commitment to providing our valued hematology customers with the highest quality of products and services available. The Software Upgrade, Revision B v1.3, was designed as an operational and data enhancement package to improve overall system operation. This package includes all the information necessary to install software Revision B v1.3 on your CELL-DYN 3200 System(s). Installation Disks (#1 and #2) Summary of Changes and Additions

30 TSB# Revision B v1.3 Software Upgrade Page 34 Installation Instructions Flagging Summary Thank you for your continued support of Abbott Laboratories and CELL-DYN products. To complete this upgrade, you will need the CELL-DYN 3200 SET-UP Disk, CELL-DYN 3000 Controls, and 3-5 normal patient specimens. The CELL-DYN 3200 internal computer system automatically completes the process of upgrading the software. The actual installation should be complete within an hour. During the software installation time period, the CELL-DYN 3200 system is unable to run specimens or retrieve results. It is very important that the system is not turned off during the upgrade process, except when instructed in the Installation Instructions. Inappropriate interruption of the installation process may result in the loss of stored data. This software upgrade does not require any hardware modification or assistance by field service. IMPORTANT NOTES: The Software Upgrade Revision B v1.3 is mandatory and must be performed on all systems. Worklist SET-UP now includes specifications for using Rack/Tube position identification for non-bar code labeled specimens. Changes have been made to WBC and RBC/PLT flagging, and therefore, all specimens run after Revision B v1.3 upgrade will use the new criteria to set flags. The instrument will now read and accept Q-label bar code identification of specific Quality Control files. It is not necessary to return any old software disks to Abbott Laboratories. As with other CELL-DYN Products, many changes and improvements have come from customer feedback. We encourage you to continue your input and we at Abbott Laboratories will remain committed to meeting your needs. If you have questions regarding this new Revision B of the software, please call the Abbott Customer Support Center at CELL-DYN ( ). International Customers, please contact your local Customer Support Representative.

31 TSB# Revision B v1.3 Software Upgrade Page 35 Sincerely, Sherb Edmondson CELL-DYN 3200 Hematology Product Manager The following is the Summary of Changes and Additions: ABBOTT DIAGNOSTICS CELL-DYN 3200 System May, 1998 Summary of Changes and Additions Software Upgrade Revision B, v1.3 The following is a summary of key changes and additions contained within the Software Upgrade Revision B, v1.3 for the CELL-DYN 3200 Hematology System. Note: If you have any questions please contact the Customer Support Center, at CELL-DYN ( ) for U.S. Customers. For International Customers, please contact your local Customer Support Representative. System Upgrades: Changes have been made to the RBC/PLT counting flow sequence to enhance precision and reduce carryover. The Shear Valve Assembly can be easily positioned for removal and cleaning, even when a system fault exists, thereby reducing the time required to remove the shear value.

32 TSB# Revision B v1.3 Software Upgrade Page 36 The combined RBC/PLT RAW DATA used by the RBC/PLT algorithm is presented on the RAW DATA SUMMARY DISPLAY. The PLT RAW DATA information has been removed. The Sample Loader rack advance mechanism attempts to index a rack three times before reporting a fault, decreasing the frequency of operator intervention. The Sample Loader sweep arms move more smoothly to provide quieter operation. A change has been made during the sample probe washing process to prevent the potential splashing of diluent from the wash block assembly. Inappropriate setting of Vacuum Accumulator Wet and Reagent Empty faults has been eliminated. A change has been made to improve the reading of I-2 of 5 bar code labels. Data Station Upgrades: The WORKLIST has a new SET-UP option for selecting Rack/Tube position as the identifier for non-bar code labeled specimens to provide easier data entry and tracking. The instrument will now read and accept Q-label bar code identification of specific Quality Control files. The Bulletin Line displays the message Load Zone Empty when racks are no longer available for processing by the Sample Loader. Algorithm Upgrades: Improvements have been made to the PLT and RBC thresholding for more precise results. The sensitivity and specificity of the Platelet LRI and URI flags have been improved. A WBC flag will be present when the WOC and NOC counts do not agree within predetermined limits. Confirmation is required before reporting these results. The following is the Flagging Summary:

33 TSB# Revision B v1.3 Software Upgrade Page 37 FLAG or DESCRIPTI ON CRITERIA CAUSE & ACTION WBC DFLT (NLMEB) RRBC/NRBC Declining WOC kinetic rate detected and more than 10% of WBC count in Region N1. Default thresholds were used for determining the 5-part Differential or declining WOC kinetic rate detected. Declining WOC kinetic rate detected and more than 2.9% WBC count in Region N1. Unusual pathology. Evaluate other flags as directed in the Operator's Manual. Review smear. Confirm the WBC value by an alternative method, according to your lab protocol. Confirm Differential. Abnormal clusters or abnormally low number of cells. Review smear. If appropriate, and if no other flags are displayed, report WBC and Differential. RRBC present. Repeat specimen in RRBC Mode to eliminate RRBCs. NRBCs may also be present. NWBC More than 2.9% WBC Count in Region N1. Potentially significant number of NWBCs below the dynamic threshold on the 0/10 degree scatterplot. Review smear to determine cause of interference. FWBC Declining WOC kinetic rate detected and/or more than 15% Lymphs in RBC region. Fragile WBC suspected. Repeat specimen in FWBC mode to obtain valid WBC count. IV. SPECIAL TOOLS: Not Applicable V. PARTS: 06H90-01 Revision B v1.3 Software Upgrade Kit REPLACED PARTS: Not Applicable

34 TSB# Revision B v1.3 Software Upgrade Page 38 COMPATIBILITY: Revision B v1.3 software is compatible with all CD3200 instruments currently using v1.1 software. VI. PROCEDURE: The following is the Installation Instructions: ABBOTT DIAGNOSTICS CELL-DYN 3200 System May 1998 Installation Instructions Software Upgrade Revision B, v1.3 The following instructions take you through a step by step procedure for installing this new software. Note: If you have questions, please contact the Customer Support Center, at CELL-DYN ( ) for U.S. Customers. For International Customers, please contact your local Customer Support Representative. Required Items: CELL-DYN 3200 Revision B v1.3 System Installation Disks #1 and #2 CELL-DYN 3200 SET-UP Disk Normal patient samples and low, normal and high level controls Approximately 1 hour is required to complete the installation Installation Procedure Preparation for installation:

35 TSB# Revision B v1.3 Software Upgrade Page Run and print the results for 3-5 normal patient specimens. 2. Run and print the results of low, normal and high level controls. 3. Save patient specimens and controls to re-run after installation is completed. 4. Perform Daily Shutdown. When STANDBY appears in the Status Box, you may continue. Backup of Current Calibration Factors, and Operator-Selected Limits and Ranges This software upgrade will not affect the calibration factors, results in the Calibration Log, QC Log, Maintenance Log, or any operator selected items in the SETUP menu. Backing up this information is a safeguard against the rare instance of power failure during the upgrade process. Backing up assures recovery of current settings if a problem occurs. Note: All entries typed at the DOS prompts are not case sensitive. 1. With the MAIN MENU screen displayed, press F12 key then the F8 key. The following message displays: CD3200 Program Terminated (0) C:\CD3200> 2. Insert the current CELL-DYN 3200 SET-UP Disk ( ) into the Instrument s Diskette Drive A (located on the right side panel of the instrument). Press and hold Ctrl and Alt keys, then press the Delete key on the keyboard. This resets the instrument s Data Station. 3. When Select (a) Abort; (s) Save; (r) Restore: [a, s, r]? displays, type s (Save). The following files are saved. Nonvol

36 TSB# Revision B v1.3 Software Upgrade Page 40 QC Log Calibration Log Worklist Log Error Log Note: If the message Write Protect Error Writing Drive A displays, eject the SET-UP Disk. Unlock the disk by moving the write protect tab in the corner. Insert the unlocked disk and press the R key on the keyboard to try again. 4. When the following prompt displays, the backup is complete: A:\> Remove the SET-UP Disk from the diskette drive and return it to the Diskette Box on the rear of the instrument. 5. Turn instrument OFF. Installation of New System Software: Insert the CELL-DYN 3200 Revision B v1.3 System Installation Disk #1 into floppy disk drive. Turn power ON. Note: Upon boot up, software on Disk #1 automatically installs. When instructed by the screen message, remove Disk #1. Insert the CELL-DYN 3200 Revision B v1.3 System Installation Disk #2 into Drive A and follow screen instructions. Follow the instructions displayed on the screen. (The instructions describe configuring the Instrument for the CS [Closed Sampler] or SL [Sample Loader].) Type Y.

37 TSB# Revision B v1.3 Software Upgrade Page 41 The following will appear: Choose [a] Abort; [s] SL model; or [c] CS model [a, s, c]. Determine system model and input [s] for SL model or [c] for CS model. Note: Failure to select correct model will result in improper operation of the instrument. When prompted by the screen message, turn the instrument power OFF and remove Disk #2. Installation is now complete and the instrument can be initialized as described in the following section. Initializing the System: Turn ON the instrument power switch. Note: The initialization process may take 3-5 minutes. DO NOT turn the instrument power OFF during this process. After the system has initialized and run a background, rerun the 3-5 normal patient specimens and the low, normal and high level controls. If you have questions regarding this new software, Revision B v1.3, please call the Abbott Customer Support Center at CELL-DYN ( ). International Customers, please contact your local Customer Support Representative. Thank you for your continued support of Abbott Diagnostics and our CELL-DYN products. Sincerely,

38 TSB# Revision B v1.3 Software Upgrade Page 42 Sherb Edmondson CELL-DYN 3200 Hematology Product Manager END OF PROCEDURE MODIFICATION STEPS: Not Applicable CHECKOUT: Refer to installation instructions attached. MODIFICATION CONTROL STICKER UPDATE: When the Rev B v1.3 upgrade has been completed, mark the modification control sticker to reflect TSB 005. END OF DOCUMENT

39 TSB# New Autoloader Mixer and Lifter Assemblies Page 43 ABBOTT ADD TECHNICAL SERVICE BULLETIN SUBJECT: TSB#: New Autoloader Mixer and Lifter Assemblies ORIGINATOR: Randy Lloyd PRODUCT: APPROVED: David C. Bannister 6/3/98 CELL-DYN 3200/SL Trademark: CELL-DYN is a registered trademark of Abbott Laboratories REF. ECO: IMPLEMENTATION: Immediate Next Service Call Next Failure Optional Instruments Requiring Modification: 59928AF and below TSB Part/Kit #: TSB Effectivity/ Part(s) Availability: 10-JUN-98 TSB Tracking by Serial # required (IMMEDIATE TSB's ONLY) YES NO Upgrade Time: 20 Min Validation Time: 20 MIN Total Mod. Time: 40 Min **NOTE** The instrument must be at TSB Level n/a prior to performing this TSB. I. DISTRIBUTION: Hematology Field Service Worldwide, Hematology CSC, TSR's, Hardware Specialist, and HTSS's. II. PURPOSE: The Autoloader mix head has been changed to provide improved capture for Sarstedt tubes. The mixer body on the mixer assembly ( ) has been shortened by 0.060". The mixer support on the mixer lifter assembly ( ) was also shortened by 0.060" to extend its movement. This change will be transparent to the use of other types of sample collection tubes, but the older assemblies will be discontinued. III. ADMINISTRATIVE NOTES: Sarstedt is a type of tube used primarily in the European Community. Rather than create two different types of autoloader, this change will be incorporated on all Cell-Dyn 3200 autoloaders manufactured after the cut in serial number above. In order to incorporate this change on an autoloader built previous to the cut-in, both the Mix Head assembly and the Mix Head Lifter assembly will need to be changed together. Both assemblies should then be returned to the factory in Santa Clara for rework. This change is to occur on a next failure basis. Use of Sarstedt tubes by a customer should be considered a potential failure.

40 TSB# New Autoloader Mixer and Lifter Assemblies Page 44 The new assemblies can be identified by the revision B marking on the box. IV. SPECIAL TOOLS:.020" feeler gauge V. PARTS: Rev B Mixer Assembly Rev B Mixer Lifter Assembly REPLACED PARTS: Both of the replaced assemblies are to be returned to the factory in Santa Clara for rework. COMPATIBILITY: The new mixer assembly and mixer lifter assembly are compatible with all Cell-Dyn 3200 autoloaders. VI. PROCEDURE: Note: This procedure is designed to reuse all the hardware and strain reliefs from the old assemblies. Do not discard any of the screws, washers, or strain reliefs on the old assemblies. Note: The slider bearing on the new mixer lifter assembly is taped into position. This is done to keep it from sliding completely off the track. If this happens, the ball bearings will escape and fall out. There is no way to restore the slider to operational condition after losing the bearings. Do not remove the tape until ready to install the mixer onto the lifter slider. When the tape is removed, be careful not to let the slider bearing slide off the track. MODIFICATION STEPS: Perform a "Daily Shutdown" with the instrument in open mode. Open the doors and remove the nose guard, and all of the autoloader skirts and covers. Remove the 4 screws underneath holding the loader assembly to the loader bracket. Rotate the loader onto its front to disconnect the vacuum/press lines and all the cables to SHM. Remove the autoloader assembly leaving the SHM mounted to the loader bracket. Turn the autoloader rightside up. Remove the strain reliefs on the front of the mixer lifter. Save the hardware and strain

41 TSB# New Autoloader Mixer and Lifter Assemblies Page 45 reliefs. (refer to figure 1) Disconnect the lifter upper sensor cable and remove the coiled strain relief. Turn the autoloader onto its front. From underneath, disconnect the air line to the lifter cylinder and to the mixer bladder. (refer to figure 2) Disconnect the cables from the mixing motor and the mix head upper sensor. From underneath, remove the 3 screws securing the lifter assembly to the autoloader baseplate. Remove the mixer and lifter assemblies together as a unit. (refer to figure 2) Remove the nyloc nut at the top of the lifter shaft. Save the nut. (refer to figure 3) Remove the 4 screws holding the mixer assembly to the slider on the lifter. Save the screws. (refer to figure 4) Note: When the mixer assembly is removed, the slider bearing will be free. Be sure to keep the slider bearing from sliding off the track. Use tape to hold the slider in place. 11. Using the same 4 screws attach the new mixer assembly to the new lifter slider. You will need to remove the tape. Be sure to align the 2 assemblies so they are square to each other before tightening the screws. 12. With the mixer secure on the slider, loosen the 2 screws holding the landing pad and square it up to the surface where it stops. When it lands square, tighten the screws. 13. Re-attach the lifter shaft with the nyloc nut. Use a feeler gauge to adjust the nut for 0.020" clearance under the nut. 14. Verify smooth operation by manually moving the lifter up and down. There should be no mechanical resistance. If necessary, loosen 2 screws securing the cylinder bracket to adjust its position to free up mechanical action. 15. Check the lifter upper sensor bracket and flag for proper alignment. 16. With the autoloader on its front, attach the assembled mixer and lifter to the autoloader baseplate with same 3 screws. 17. Route the tubing and cables through the hole in the baseplate and re-attach all of the cables and tubing, reversing the previous steps. 18. Turn the autoloader rightside up again and check for smooth operation of the lifter. There should be no mechanical friction. If necessary, loosen 2 screws securing the cylinder bracket to adjust its position to free up mechanical action. 19. Re-check the landing pad to make sure it is square to the surface it stops on. 20. Check the nyloc nut clearance to be 0.020". 21. Check the clearance of the bottom of the mix head to the top of the rack guide. It should be at least 0.020". 22. Re-attach the strain reliefs to front of the slider, and re-attach the coiled strain relief to cables.

42 TSB# New Autoloader Mixer and Lifter Assemblies Page Place the autoloader into the autoloader bracket, turn it forward and re-attach the air lines and all of the cables to the SHM. 24. Turn the autoloader rightside up and re-attach autoloader to bracket. Figure 1 To view the next section of this TSB (Figure 2) click once on this button Continue to SECTION 2 See Figure 3 in SECTION 3 of this TSB. See Figure 4 in SECTION 4 of this TSB.

43 TSB# New Autoloader Mixer and Lifter Assemblies Page 47 CHECKOUT: 1. Power up the instrument and use the autoloader diagnostics to exercise all the loader functions. 2. When finished and the loader tests OK, re-attach all the covers. Perform the cycle test from the installation procedure. 3. Perform a closed mode precision check. MODIFICATION CONTROL STICKER UPDATE: Mark the modification control sticker to reflect the status level of 004. END OF DOCUMENT END OF DOCUMENT

44 TSB# New Autoloader Mixer and Lifter Assemblies Page 48 To view the previous section of this TSB click once on this button Return to SECTION 1 SECTION 2 Figure 2 To view the next section of this TSB (Figure 3) click once on this button Continue to SECTION 3

45 TSB# New Autoloader Mixer and Lifter Assemblies Page 49 To view the previous section of this TSB click once on this button Return to SECTION 2 SECTION 3 Figure 3 To view the next section of this TSB (Figure 4) click once on this button Continue to SECTION 4

46 TSB# New Autoloader Mixer and Lifter Assemblies Page 50 To view the previous section of this TSB click once on the button Return to SECTION 3 SECTION 4 Figure 4 END OF DOCUMENT

47 TSB# New Hemaglobin Flow Cell Assembly Page 51 ABBOTT ADD TECHNICAL SERVICE BULLETIN SUBJECT: TSB#: New Hemaglobin Flow Cell Assembly ORIGINATOR: Randy Lloyd PRODUCT: APPROVED: John C Stout 05/01/98 CELL-DYN 3200/SL Trademark: CELL-DYN is a registered trademark of Abbott Laboratories REF. ECO: IMPLEMENTATION: Immediate Next Service Call Next Failure Optional Instruments Requiring Modification: AF and below TSB Part/Kit #: TSB Effectivity/ Part(s) Availability: 05/15/98 TSB Tracking by Serial # required (IMMEDIATE TSB's ONLY) YES NO Upgrade Time: 20 Min Validation Time: 10 Min Total Mod. Time: 30 Min **NOTE** The instrument must be at TSB Level n/a prior to performing this TSB. I. DISTRIBUTION: Hematology Field Service Worldwide, Hematology CSC, TSR's, Hardware Specialist, and HTSS's. II. PURPOSE: The HGB flow cell assembly has been changed to improve serviceability. A quick disconnect has been added to the cable. This change will allow the HGB flow cell to be changed without needing access to the FCM PCB located in the interior of the instrument. Except for the new quick disconnect cable, the new HGB flow cell assembly is the same as the old assembly. III. ADMINISTRATIVE NOTES: There will be a stock sweep and rework of all of the old HGB flow cell assemblies. The new HGB flow cell can be ordered as needed ( ). In order to install the new HGB flow cell on an instrument built previous to this change, the detachable cable must be ordered separately ( ). This change is to occur on a next failure basis.

48 TSB# New Hemaglobin Flow Cell Assembly Page 52 IV. SPECIAL TOOLS: Not Applicable V. PARTS: HGB Flow Cell Assembly, CD Cable Assembly, HGB Flow Cell, CD3200 REPLACED PARTS: Discard COMPATIBILITY: The new HGB flow cell assembly and cable is compatible with all Cell-Dyn 3200 instruments. VI. PROCEDURE: The laser bench will need to be removed in order to install the new cable. Before proceeding with the modification, verify the laser bench performance is within specifications using 7.0 latex. Print out the [Calc CV] screen and the "butterfly" for later comparison. MODIFICATION STEPS: Laser Bench Removal In open mode, perform a [Daily Shutdown]. Disconnect the power cable from the outlet. Open the doors and remove the nose guard, left side cover, and top cover. Remove the large black laser bench cover. Open the flow cell cover and disconnect the 5 tubings from the top of the manifold. Carefully place the tubing inside the cover in such a way to prevent damage when the bench is removed. Mark and disconnect the 4 optical channel cables. Place them out of the way. Disconnect the laser tube high voltage cable from the laser power supply. Remove the 5 screws holding the laser bench mounting plate to the chassis. Carefully lift the bench up, tilting it up at the rear just enough to clear the frame. Rotate the bench just enough to allow the corners of the mounting plate to be placed down on top of the frame rails. Be careful not to yank the AC cable underneath.

49 TSB# New Hemaglobin Flow Cell Assembly Page reach in from the left side and disconnect the AC cable from the main power supply. 10. Remove the bench and place it in such a way to protect the power supply on the bottom. Change HGB Flow Cell Disconnect the HGB cable from J18 on the FCM PCB. Feed the old cable out through the flow panel. Remove the 4 tubings from the HGB flow cell. Remove the 2 screws securing the cover and remove it. Remove the 2 long screws holding the flow cell to the flow panel. Remove and discard the old flow cell. Install the new flow cell by reversing steps 2-4. Connect the new cable ( ) to J18 on the FCM and feed the cable through the hole in the flow panel. Connect the cable to the HGB flow cell and dress it appropriately Re-install the Laser Bench Place the bench on top of the frame as before and connect the AC cable to the main power supply. Carefully rotate the bench and lift it back in tilting it slightly down at the front. Replace the 5 screws holding the mounting plate to the chassis. Connect the high voltage cable, the 4 signal cables, and the 5 tubings (as marked). Replace the large black cover over the bench. Perform the check out below before installing the covers. CHECKOUT: 1. Power up and prime the instrument. Verify background Perform flow cell adjustment (VP-20 in CD3000 troubleshooting guide) Perform HGB current adjustment (VP-5 in CD3200 Service Manual). Verify precision and control performance. Recalibrate as necessary. MODIFICATION CONTROL STICKER UPDATE: Update the modification sticker to reflect the change. END OF DOCUMENT

50 TSB# Block II Retrofit Page 54 ABBOTT ADD TECHNICAL SERVICE BULLETIN SUBJECT: TSB#: Block II Retrofit ORIGINATOR: Randy Lloyd PRODUCT: APPROVED: John C Stout (6/23/98) CELL-DYN 3200/SL (109) Trademark: CELL-DYN is a registered trademark of Abbott Laboratories REF. ECO: IMPLEMENTATION: Immediate Next Service Call Next Failure Optional Instruments Requiring Modification: Below SN 59965AF Instrument Revision F TSB Part/Kit #: TSB Effectivity/ Part(s) Availability: 01-JUL-98 TSB Tracking by Serial # required (IMMEDIATE TSB's ONLY) YES NO Upgrade Time: 3.0 Validation Time: 0.5 Total Mod. Time: 3.5 **NOTE** The instrument must be at TSB Level n/a prior to performing this TSB. I. DISTRIBUTION: Hematology Field Service Worldwide, Hematology CSC, TSR's, Hardware Specialist, and HTSS's. II. PURPOSE: This document details the field retrofit upgrades to the Cell-Dyn 3200 instrument which are associated with the "Block II" changes. The block II changes have been incorporated to enhance the overall serviceability and manufacturability of the CD3200 instrument. Refer to ISA for detailed information on the block II manufacturing release. Some of the aspects of block II are field retrofitable and others are not. There is a retrofit kit ( ) for upgrading instruments built previous to the changes on a next service call basis. The block II manufacturing release will be instrument revision F. Previous revisions will need the upgrade.

51 TSB# Block II Retrofit Page 55 III. ADMINISTRATIVE NOTES: Expect the upgrade to take 3 hours. Due to the extensive disassembly and cable re-routing necessary, it is recommended that only experienced FSRs perform this upgrade. The kit modifications will include changing the location of the SHM2 PCB, which will be re-mounted to the inside of the left front door. This will require changing or extending all of the cables from the autoloader to SHM2. This will involve complete rework of the autoloader cabling harness. The retrofit will also require changing the power cable routed to SHM2 from the PDM in the computer door, and the flat bus cable from the CPU/DCM PCB. This will involve removal of the laser bench and opening the computer door to gain the necessary access. The retrofit kit (PN ) contains the following: (listed in part number order) Part # Qty Description x1 Coupler jack (bar code reader) x1 Terminal (quick disconnect) x1 Fan guard (wire mesh) x4 Screw, 8-32, 2" long x4 Screw, self tapping x1 Nut x4 Nyloc Nut, x2 Velcro fastener strips, 3/4" wide x4 Velcro discs, 13/16" diameter x1 Screw, Phillips, pan head, x4 Standoffs, 8-32, 1/4" long nylon x4 Washer, flat x1 Cable clamp, 1" i.d. nylon x10 Tie wrap, medium nylon x3 Twist Loc fastener, 1" i.d. nylon X1 Waste bottle, isoplast x1 Cosmetic Cover, left side x1 Fan bracket

52 TSB# Block II Retrofit Page x1 Door, left front access x2 Cover, PCB x1 Cable assembly, rack sensor x1 Cable assembly, mix motor x1 Cable assembly, mixer sensor x1 Cable assembly, bar code reader extender x1 Cable assembly, solenoid extender x1 Cable assembly, tube sensor x1 Cable assembly, ground, 10" long x1 Cable assembly, SHM / CPU x1 Cable assembly, SHM2 / PDM IV. SPECIAL TOOLS: Not Applicable V. PARTS: Upgrade kit, Block II REPLACED PARTS: Discard all replaced parts. COMPATIBILITY: The block II upgrade kit is designed to be used on all instruments built previous to the manufacturing block II release, instrument revision F. Refer to serial number information above. VI. PROCEDURE: 1) Verify all kit parts are present. Use list above. 2) Use the diagnostics to verify all autoloader functions. Be sure to check out all the sensors and the bar code reader. 3) Run 3 whole blood samples in closed mode for post retrofit comparison data. Print out the results. Be sure to identify the samples with the results.

53 TSB# Block II Retrofit Page 57 4) With the instrument in open mode, perform a daily shutdown. 5) Remove the power cord from the outlet. 6) Proceed with modification steps. Then the checkout steps. MODIFICATION STEPS: I. New left door, and velcro fasteners: a) Find the new left door (PN ), 4 round velcro discs (PN ), 4 self tapping screws (PN ), 4 washers (PN ), 2 velcro strips (PN ), 1 quick disconnect terminal (PN ), 1 ground cable (PN ). b) Remove the existing left front door. Disconnect the ground cable. Save the screw and discard the cable and door. c) Place one of the round velcro discs (PN ) over the landing pad on the inside top of the new door. Align it to the bottom edge and center it on the pad. Mark the position of the hole with a pencil. Position the self tapping screw over the mark and carefully screw it in, then remove it. The material is soft enough for the screw to make its own threaded hole. Remove the screw and the debris from the hole. Then use the screw and the washer to screw the velcro disc in place. Do not overtighten. d) On the existing nose guard and right door remove the old push prongs by removing the small screw, then prying them off with pliers. Peel off any remaining adhesive backing, and make threaded holes using the self tapping screws. Apply the velcro discs. Do not overtighten. e) Remove the top cover and laser bench cover. Set them aside for now. Remove all 4 of the old push type fasteners from the frame by squeezing the tabs on either side and discard them. Apply the adhesive backed velcro strips (PN ) over the holes. Do not let the strips overlap the frame rail. Note that one strip is longer than the other. f) Attach the new left door to the hinge. Remove the nearest phillips screw along the top of the flow panel and attach the quick terminal (PN ) to the flow panel. Attach the ground cable to the terminal and screw it into the boss on the door. II. Waste Chamber 2: a) Remove waste chamber 2, from the flow panel. Replace it with the new chamber from the kit (PN ). Orient the waste chamber with the small barb to the rear. III. Fan relocation: a) Find the new fan bracket (PN ), Fan guard (PN ), x4 Screws 2" (PN ), x4 Nyloc nuts (PN ), and left side cover (PN ). b) Remove the left side panel and discard it. Remove the screws securing the fan bracket, and disconnect the AC cable from the fan. Remove the snap fit filter retainer and fan filter. Remove the screws and nuts securing the filter retainer

54 TSB# Block II Retrofit Page 58 mount, the fan, and the finger guard to the bracket. Discard the old finger guard, fan bracket, 4 nuts, and 4 screws. c) Mount the fan onto the new fan bracket using the new mesh finger guard. Be sure to observe the arrow markings on the fan body to orient it properly. The air flow arrow should be pointed in. The AC connection needs to be on the left side. Use the old retainer mount, filter retainer, and filter. Connect the AC cable and re-attach the bracket to the frame. The new cover will now fit on allowing changing of the filter without removing the cover. Leave the cover off for now to allow removal of the laser bench. IV. Replace SHM2 CPU cable and power cable: * Remove autoloader: a) Remove the autoloader bottom cover and skirt. Remove the 4 screws holding the autoloader to the mounting bracket. b) Tilt the assembly forward and rest it on its front side. This will provide clearance to reach in and disconnect the air lines and all the cables from SHM2. Remove the autoloader assembly and set it aside. * Remove laser bench: a) Remove the top cover and the large black laser bench cover. b) Open the flow cell cover and disconnect the 5 tubings from the top of the manifold. Carefully place the tubing inside the cover in such a way to prevent damage when the bench is removed. Mark and disconnect the 4 optical channel cables. Place them out of the way. c) Remove the 5 screws holding the laser bench mounting plate to the chassis. Carefully lift the bench up, tilting it up at the rear just enough to clear the frame. Rotate the bench just enough to allow the corners of the mounting plate to be placed down on top of the frame rails. Be careful not to yank the AC cable underneath. d) Reach in from the left side and disconnect the AC cable from the main power supply. Remove the bench and place it in such a way to protect the power supply on the bottom. * Open computer door: a) Disconnect all of the cables from the back of the computer assembly. b) Remove the right side cover. Loosen the two thumb screws and open up the computer door. * Change 2 cables: a) Find the new SHM2 CPU cable (PN ), and the SHM2 power cable (PN ). b) Remove the existing SHM2 CPU cable from the instrument. The easiest way to do this is to disconnect the cable from both ends (J16 SHM & J17 CPU/DCM) and cut the connectors off. This will allow the cable to feed through without cutting all the cable ties. c) With the instrument opened up, remove the existing SHM2 power cable from the instrument. The power comes from

55 TSB# Block II Retrofit Page 59 the PDM in the computer door. The easiest way to do this is to disconnect the cable from both ends and cut the connectors off. This will allow the cable to feed through without cutting all the cable ties. J12 & J13 on the PDM are the same. The existing cable should be on PDM J13, but could be on PDM J12. Be sure to disconnect and cut the correct cable. Use multimeter to check continuity if in doubt. d) Route the new SHM2 CPU cable (PN ) through to the CPU/DCM to J17. Tuck the cable underneath the existing tie wraps if there is enough slack. If not you will need to dress the cable later using new tie wraps. Route it through the center harness to the front. From there, route the SHM cable behind the flow panel across the top of the FCM over to the left side. Loosen the peri-pump and route the SHM cable through the cutout for the peri-pump. Be careful not to squeeze the cable when the peri-pump is re-tightened. Position it to leave a narrow gap on the left side. e) Observe the cable connectors on the new SHM2 power cable (PN ). The connector on the PDM end is keyed. Be careful not to get the cable reversed. Route it through to the PDM J13 and through the center harness to the front. Try to tuck it in under the existing cable ties. From there route the cable over to the right side of the flow panel where there is an extra rubber grommet through the flow panel. Route the cable through the grommet and along the autoloader mounting bracket. When the autoloader is installed the cable will be under the baseplate. when in place use extra cable ties to dress both cables as necessary. f) When both cables are routed and dressed, the computer door can be closed and the laser bench re-installed. Reverse the previous steps. Leave the autoloader aside for now. V. Relocate SHM2 PCB to the door a) Find the 4 PCB standoffs (PN ) in the kit. Screw them into the bosses in the new left side door. Be careful not to overtighten them. Remove the SHM PCB from the autoloader bracket and remove the old standoff from the bracket. Discard the old standoffs. b) Place the PCB onto the new standoffs with the solenoid connectors on the left. The power connector J12 will be on the bottom. Push the PCB onto the standoffs until it is seated. Connect the SHM2 bus cable to J16 and the power cable to J12. VI. Install and re-dress the autoloader cables. a) Find the 3 twist loks (PN ), 10 cable ties (PN ), 1 cable clamp (PN ), 1 rack sensor cable (PN ), 1 mix motor cable (PN ), 1 mixer sensor cable (PN ), 1 bar code reader cable (PN ), 1 coupler jack (PN ), 1 solenoid extender cable (PN ), 1 tube sensor cable (PN ), 2 plastic PCB cover (PN ). b) Place the autoloader on a surface to allow hand work. Remove the all of the strain reliefs and cut cable ties as necessary to remove all of the old cables. Leave the solenoid cables intact and tied together. All of the new cables have the destinations marked on each end. Use the part numbers to identify each new cable. Install the new cables to the autoloader one at a time. c) Connect the solenoid extender cable (PN ). The connections are numbered. Connect the bar code reader

56 TSB# Block II Retrofit Page 60 extender cable (PN ) using the coupler jack (PN ). d) When all the new cables are installed use cable ties to form a new cable harness to route the cables to the left side of the autoloader (for example see Figure 1 ). Make the harness as neat as possible and be sure to avoid interference with the sweep arms and index rail mechanisms. e) Place the autoloader onto the mounting bracket resting on its front side. Connect the cables to the proper destinations on the SHM2 PCB. Make a note of the locations of the cutouts in the plastic PCB cover that will go over SHM2 (PN ). Group the cables together to form a neat harness that will loop around to the top of the PCB (for example see Figure 2 ). Use cable ties as necessary to keep the cables neat. f) Re-attach the autoloader to the bracket. Find the nut (PN ), screw (PN ), and cable clamp (PN ). Fasten the cable harness to the lower door hinge using the cable clamp. (for example see Figure 2 ). CHECKOUT: 1) Power up and initialize the instrument. Use the diagnostics to verify all autoloader functions. Be sure to verify all mechanical functions, operation of all the sensors, mix head capture, and the bar code reader. 2) Install the covers on the SHMs. Install all the covers on the autoloader and the instrument. 3) Prime the instrument and perform optical flow cell adjustment (VP-20 in CD3000 troubleshooting guide). 4) Re-run the 3 comparison blood samples from step 2 of the initial procedure in closed mode. Verify all results match previous values. 5) Verify instrument whole blood precision and control recovery. MODIFICATION CONTROL STICKER UPDATE: Mark the modification sticker for TSB 002. END OF DOCUMENT

57 TSB# Block II Retrofit Page 61 TSB FIGURE 1 ESC to exit

58 TSB# Block II Retrofit Page 62 TSB FIGURE 2 ESC to exit