Abbott CELL-DYN 3200 System Operator's Manual

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CELL-DYN

3200 System Operator's Manual

9140181K—July 2002

We welcome you to the role of Operator of the CELL-DYN 3200 System. Using

state-of-the-art technology, we have designed your instrument to function

consistently and dependably on a day-to-day basis.

The CELL-DYN 3200 System is backed by dedicated professionals who excel in

engineering, training, and technical expertise. As you are a valued customer, we

will teach you how to operate, maintain, and troubleshoot your system.

For continuing service, we also provide telephone technical assistance should you

need additional information or assistance in diagnosing a problem. This service is

available 7 days a week, 24 hours a day in the United States.

If a problem should arise that cannot be resolved by telephone, on-site support is

offered by Abbott's Field Service Representatives. Our Field Service

Representatives are extensively trained in all aspects of Abbott instrumentation,

which assures proficiency in diagnosing, isolating, and correcting problems.

Abbott Laboratories is dedicated to manufacturing the highest quality, most

reliable instrumentation available. We look forward to serving your needs in any

way possible.

United States: 1 (800) CELL DYN or 1 (800) 235-5396

Abbott Diagnostics Customer Support Center:

200 Abbott Park Road

Abbott Park, Il 60064

Canada: 1 (800) 387-8378

For customers outside the U.S., call your local Hematology Customer Support

Representative.

The CELL-DYN 3200 is a multiparameter hematology analyzer designed for in

vitro diagnostic use in clinical laboratories.

The entire contents copyrighted 1995, 1998, 1999, and 2001 by Abbott

Laboratories. Abbott Laboratories' software programs are protected by copyright.

All rights are reserved. The software was developed solely for use with Abbott

Laboratories equipment and for in vitro diagnostic applications as specified in the

operating instructions. No part of this document may be reproduced, stored, or

transmitted in any form or by any means (electronic, mechanical, photocopied,

recorded, or otherwise) without the prior written permission of Abbott

Laboratories.

Foreword

Table of Contents

Chapters

Table of Contents

Summary of Contents for Abbott CELL-DYN 3200

Page 1 Foreword We welcome you to the role of Operator of the CELL-DYN 3200 System. Using state-of-the-art technology, we have designed your instrument to function consistently and dependably on a day-to-day basis. The CELL-DYN 3200 System is backed by dedicated professionals who excel in engineering, training, and technical expertise.
Page 2 Abbott’s labor rates then in effect. This Warranty does not cover defects or malfunctions which: 1. Are not reported to Abbott during the Warranty Period and within one week of occurrence. 2. Result from chemical decomposition or corrosion.
Page 3 Abbott’s liability for all matters arising from the supply, installation, use, repair, and maintenance of the Instrument, whether arising under this Warranty or otherwise, shall be limited solely to the repair or (at Abbott’s sole discretion) replacement of the Instrument or of components thereof. In no event shall Abbott be liable for injuries sustained by third parties, incidental or consequential damages, or lost profits.
Page 4 Canon is a registered trademark of Canon Inc. CELL-DYN is a registered trademark of Abbott Laboratories. CELL-DYN HemCal is a registered trademark of Abbott Laboratories. Epson is a registered trademark of Seiko Epson Inc. Hemogard is a registered trademark of Becton Dickinson and Company.
Page 5 Symbols The symbols listed below are used on CELL-DYN labeling, including the instrument, reagents, calibrators, controls, and this manual. Please note that Warning and Caution symbols and statements are in this manual in Section 8: Hazards. Instrument/Power related Alternating Current $&...
Page 6 Reagent related Cyanide-Free Hemoglobin/Nucleated Optical Count Lyse &1)5(( +*%12& /<6( Diluent ',/8(17 Diluent/Sheath ',/8(176+($7+ Enzymatic Cleaner Concentrate (1=<0$7,& &/($1(5 &21&(175$7( Expiration Date Hemoglobin +(02*/2%,1 Hemoglobin Hemoglobin Lyse +*% /<6( Lot Number Red Blood Cell 5%& Sheath 6+($7+ Storage temperature. (Example shows “Store at 2º–8ºC”) White Blood Cell :%&...
Page 7 Miscellaneous Authorized Representative (& 5(3 Consult instructions for use Date of Manufacture For In Vitro Diagnostic Use Legal Manufacturer List Number CELL-DYN 3200 System Operator’s Manual ® 9140181K—July 2002...
Page 8 Instrument Labeling The following labels are affixed to the CELL-DYN 3200 System: Current CELL-DYN customer’s instruments are CE Marked to the European Electro-Magnetic Compliance (EMC) and Low-Voltage Directives and have the following labels: DANGER GEFAHR DANGER PELIGRO PERICOLO LASER LIGHT WHEN OPEN.
Page 9 WARNING : SET FOR 120 VOLTS When operation at other line voltage is required, refer to operation manual for detailed instructions. WARNUNG : FUER 120 VOLT EINGESTELLT Ist der Betrieb mit einer anderen Netzspannung erforderlich, entnehmen Sie die genauen Anweisungen der Bedienungsanleitung. MISE EN GARDE : PARAMETRE POUR UTILISATION SUR 120 VOLTS Si une utilisation à...
Page 10 CLASS 1 LASER PRODUCT PN 9230702 Laser Label, Rear Panel ABBOTT DIAGNOSTICS DIVISION Abbott Laboratories Abbott Park IL, 60064 USA THIS PRODUCT CONFORMS TO THE APPLICABLE REQUIREMENTS OF 21 CFR SUBCHAPTER J AT THE DATE OF MANUFACTURE DATE OF MANUFACTURE MADE IN U.S.A.
Page 11 ABBOTT LABORATORIES Abbott Park, IL 60064 USA ABBOTT Max-Planck-Ring 2 65205 Wiesbaden Germany +49-6122-580 PN 9230751A CE Mark Label, Rear Panel WARNING: SET FOR 120 VOLTS When operation at other line voltage is required, refer to Operator’s Manual for detailed instructions.
Page 12 NOTES CELL-DYN 3200 System Operator’s Manual ® 9140181K—July 2002...
Page 13 Section 2. Installation Procedures and Special Requirements This section provides instructions for installing the CELL-DYN 3200 system. It explains proper location, installation, setup, and configuration to meet your laboratory’s specific needs.
Page 14 Section 4. Performance Characteristics and Specifications This section contains useful details on the dimensions of the instrument, proper operating environment, and performance specifications. Section 5. Operating Instructions This section contains detailed instructions to set up the instrument and explains the procedures for daily start-up and shutdown, sample collection and handling, routine operation of the instrument, sample analysis, and use of the data log.
Page 15 QC and retic patient limits, and prepare and process retic samples. Appendices Appendix A describes how to use bar codes on the CELL-DYN 3200 and contains information on bar code types and bar code labels. Appendix B lists the part numbers of components, accessories, controls, reagents, and consumables associated with the CELL-DYN 3200 System for user convenience when placing orders.
Page 16 Text Conventions Used in This Manual The following list summarizes the text conventions that are used in this manual: Information Presentation Examples MAIN MENU Menu name Sans serif font, all capital letters DATA LOG menu [RUN] Soft keys (screen label keys) Sans serif font, all capital letters, enclosed in brackets Keyboard/keypad keys...
Page 17 All work must be performed as described in the CELL-DYN Operator’s manual or as directed by an Abbott Representative. For detailed safety information, refer to Section 8: Hazards. Warnings are inserted throughout this manual to alert personnel to potential hazards.
Page 18 Revision Status Document Control Revision Section(s) Pages Revised Number(s) Date Revised and Added 9140181H 10/01 9340541B All (new tabset) 9140181J 3/02 Forward How To Use This Manual Master Table of pp. 1 through 5; 12 through 14; 19 Contents List of Figures p.
Page 19 Document Control Revision Section(s) Pages Revised Number(s) Date Revised and Added NOTE: For existing customers, pages of 9140181J will be changed to Revision K and sent with 9140181K 9140181K 7/02 Forward How To Use This Manual Master Table of pp. 1 through 5; 10; 12 through 20 Contents List of Figures pp.
Page 20 2. Record the revision date, also found in the footer, in the second column. 3. Record the current CELL-DYN 3200 System software version in the third column. 4. Write your initials or signature in the fourth column to verify that you have placed the revised page(s) in the manual.
Page 21 Pictorial Disclaimer ........ii Abbott Instrument Warranty ....... . . ii Regulatory and Safety Agency Approvals .
Page 22 Master Table of Contents Front Skirt Cover ........1-9 Status Indicator Panel .
Page 23 CELL-DYN 3200 CN-Free HGB/NOC Lyse....1-26 CELL-DYN 3200 WBC Lyse......1-26 Reticulocyte Reagent System—CELL-DYN Reticulocyte Reagent1-27...
Page 24 Master Table of Contents Normally Closed Valves........2-6 Open Left Front Cover .
Page 25 Master Table of Contents Resistant RBC........3-16 WBC Histograms .
Page 26 Master Table of Contents Performance Characteristics and Specifications ....... . 4-1 Overview.
Page 27 Master Table of Contents Operating Instructions ............5-1 Overview.
Page 28 Master Table of Contents Soft Key Description ....... . 5-68 Clear Fault.
Page 29 Master Table of Contents Flow Errors ......... . . 5-97 3 Consecutive Flow Errors .
Page 30 Master Table of Contents Calibration Procedures ............6-1 Overview.
Page 31 Master Table of Contents Enter Factor Method ......... . 6-33 Overview.
Page 32 Master Table of Contents Hazards..............8-1 Overview.
Page 33 Master Table of Contents Procedure—CS and SL Models ......9-14 Clean Aspiration Needle ....... . . 9-15 Materials Required .
Page 34 Master Table of Contents Disabling the Analyzer ....... 9-40 Procedure—Sample Injection Syringe ..... . 9-42 Procedure—HGB Lyse Syringe .
Page 35 Master Table of Contents Troubleshooting and Diagnostics ..........10-1 Overview.
Page 36 Running Controls ........11-17 CELL-DYN 3200 Westgard ®...
Page 37 Master Table of Contents Sample Loader ............. . 13-1 Overview.
Page 38 Master Table of Contents Reticulocyte Package ............14-1 Overview.
Page 39 Master Table of Contents Clear Fault........14-49 Patient Specimen.
Page 40 Overview........... . B-1 CELL-DYN 3200 Accessories ......B-1 CELL-DYN 3200 Optional Accessories .
Page 41 Tubing in a Normally Closed Valve ......2-10 Figure 2.7 CELL-DYN 3200 Printer Ports ......2-12 Figure 2.8 Analyzer With Sample Loader .
Page 42 List of Figures Operating Instructions Figure 5.1 Main Menu Screen ........5-4 Figure 5.2 Set Up Menu Screen .
Page 43 List of Figures Figure 5.41 Work List Screen - Page 1 ......5-108 Figure 5.42 Work List Screen - Page 2 .
Page 44 List of Figures Service and Maintenance Figure 9.1 First Special Protocols Screen ......9-3 Figure 9.2 Reagent Reservoir Keys .
Page 45 Analyzer With Sample Loader ......13-1 Figure 13.2 CELL-DYN 3200 Sample Loader ......13-5 Figure 13.3 Tube Labeling Requirements .
Page 46 List of Figures Figure 14.11 Units Selection Screen ....... . . 14-23 Figure 14.12 Reticulocyte Data Log Screen .
Page 47 List of Tables List of Tables Principles of Operation Table 3.1 5-Part Differential ........3-25 Table 3.2 5-Part Differential Plus Additional Parameters .
Page 48 CELL-DYN 3200 Controls/Calibrator ..... . . B-3 Table B.5 CELL-DYN 3200 Reagents ....... B-4 Table B.6 CELL-DYN 3200 Reagent Inlet/Outlet Tubing .
Page 49 (CELL-DYN 3200CS). An example of each version is shown in Figure 1.1 and 1.2. The term CELL-DYN 3200 refers to both versions unless either the Closed Sampler (CS) or Sample Loader (SL) model is specifically stated. The terms open sample and closed sample are used interchangeably with open sampler and closed sampler.
Page 50 Both models aspirate blood from open collection tubes. This method is referred to as the Open Sampler mode. Intended Use The CELL-DYN 3200 is a multiparameter, automated hematology analyzer designed for in vitro diagnostic use in clinical laboratories. The CELL-DYN 3200 generates the following hematologic measurements on EDTA-anticoagulated whole blood: WBC —...
Page 51 Section 1 Use or Function MCHC — Mean Cell Hemoglobin Concentration RDW — Red Cell Distribution Width PLT — Platelet or thrombocyte count MPV — Mean Platelet Volume PDW*— Platelet Distribution Width PCT* — Plateletcrit Retic %—Reticulocyte Percent Retic Abs—Reticulocyte Absolute Count * Clinical significance has not been established for these parameters.
Page 52 Use or Function Section 1 Overview NOTES CELL-DYN ® 3200 System Operator’s Manual 9140181H—October 2001...
Page 53 Use or Function System Components The CELL-DYN 3200 consists of three major modules, the Analyzer, Data Module, and the Display Station. The Analyzer and Data Module are housed in single chassis. The Display Station is a standalone module. Figure 1.3 lists the major subassemblies in each of the modules.
Page 54 Use or Function Section 1 System Components Analyzer Components The major components of the Analyzer are listed below and shown in Figures 1.4 through 1.8. Front Panel Right Front Cover Left Front Cover Front Skirt Cover (CS model) Sample Loader (SL model) Status Indicator Panel Closed Sample Tower Cover Open Sample Aspiration Probe with Touch Plate...
Page 55 Section 1 Use or Function Rear Panel Main Power Switch Main Power Connector Display Station Communications Connector Line Frequency and Line Voltage Select Switches Fuse Fan with Air Intake Filter Serial and Parallel Interface Ports (Data Module) Keyboard Connector Port Touch Pad Connector Port Waste Sensor Connector Waste Outlet Tube Connector...
Page 56 Use or Function Section 1 System Components Component Description Front Panel The major components of the Front Panel are depicted in Figure 1.4. A brief description of each component’s function follows. 1 Left Front Cover 2 Right Front Cover 3 Status Indicator Panel 4 Aspiration Probe 5 Touch Plate 6 Sample Loader...
Page 57 Section 1 Use or Function Front Skirt Cover (not pictured) The Front Skirt Cover protects the lower front part of the flow panel. The skirt should be removed to access the two lower Normally Closed Valves on the left side of the Flow Panel.
Page 58 Use or Function Section 1 System Components Flow Panel The major components of the Flow Panel are depicted in Figure 1.5. A brief description of Flow Panel components follows. 1 Vent Filter 2 Vent 3 Sample Transfer Peristaltic Pump 4 Waste Chambers 5 WBC Mixing Chamber 6 RBC Mixing Chamber 7 HGB Flow Cell...
Page 59 Section 1 Use or Function Syringe Assembly There are two syringe driver assemblies, each containing two syringes. Each syringe is operated by its own stepper motor. The function of each syringe is described below: • Diluent/Sheath Syringe — (1) delivers a specific volume of diluent to transport the RBC segment from the Shear Valve to the RBC/PLT Mixing Chamber and to dilute the segment prior to measurement, and (2) delivers a specific volume of diluent to transport the HGB segment from the Shear...
Page 60 Use or Function Section 1 System Components Normally Closed Valves The Normally Closed Valves prevent the backflow of reagents in critical areas when the power is turned off. Diluent Reservoir The Diluent Reservoir maintains the diluent supply for cleaning and sample dilution.
Page 61 Section 1 Use or Function Bar Code Reader The Bar Code Reader is an LED type and can accommodate Code 39, Code 128, CODABAR, and Interleaved 2 of 5 formats. On the CS model, the Bar Code Reader is located to the right of the door opening on the Door Assembly. On the SL model, the Bar Code Reader is located to the left of the Mixing Assembly on the Sample Loader.
Page 62 Use or Function Section 1 System Components Left Side Panel The only major component on the Left Side Panel is the Fan, shown in Figure 1.6. A Fan cools the internal components of the Analyzer. 1 Fan Figure 1.6 Left Side Panel 1-14 CELL-DYN ®...
Page 63 Section 1 Use or Function Right Side Panel The only major component on the Right Side Panel is the Floppy Disk Drive shown in Figure 1.7. 1 Floppy Disk Drive Slot Figure 1.7 Right Side Panel Components Floppy Disk Drive (Slot) The Floppy Disk Drive allows information to be downloaded or uploaded using a 3.5"...
Page 64 Sample Loader (SL model only). Analyzer Serial Number Label Although not an instrument component, the Analyzer Serial Number may be required when consulting with the Abbott Hematology Customer Support Center. Data Module See Subsection: Data Module Components later in this section.
Page 65 Section 1 Use or Function Waste Sensor Connector The waste-full sensor plug connects to the Waste Sensor Connector port. The ground shield on the cable should be attached to the Ground Connector on the rear panel. When the electrical sensor is tripped, the EXTERNAL WASTE FULL message is generated and the READY status is inhibited until the situation is corrected.
Page 66 Use or Function Section 1 System Components Line Frequency and Line Voltage Select Switches These switches are used to select the Line Frequency and Voltage for the Analyzer (refer to Figure 1.9). WARNING: SET FOR 120 VOLTS When operation at other line voltage is required, refer to Operator’s Manual for detailed instructions.
Page 67 Section 1 Use or Function Top Panel Flow Cell Assembly The Flow Cell Assembly contains the fluidics and hardware needed to hydrodynamically focus the RBC/PLT and WBC sample streams in the path of the laser beam for analysis. The primary components of this assembly are: •...
Page 68 Use or Function Section 1 System Components Data Module Components The major components of the Data Module are depicted in Figure 1.11. A description of each component’s function follows. 1 PC Keyboard Connector 2 COM1 (LIS Connector) 3 COM2 (Unused) 4 Analyzer BDM Diagnostics (Unused) 5 HSSL Connector...
Page 69 Section 1 Use or Function The floppy disk drive is used to update the software program and to download data. The hard drive is used to store the User Interface Software and Patient Data Log. It has sufficient capacity to store the most recent 10,000 cycles, including numeric and graphics data.
Page 70 Use or Function Section 1 System Components Display Station Components The major components of the Display Station are shown in Figure 1.12. A description of each component’s function follows. 1 Membrane Keypad Screen Controls 2 Degauss 3 Side Pincushion 4 V Size 5 V Shift 6 H Size 7 H Shift...
Page 71 Section 1 Use or Function Video Cable (not shown) The Video Cable allows data from the Data Module to be transferred to the Display Monitor. Power Cord (not shown) A built-in power cord on the Display Station connects to an outside power supply and provides power to the monitor and keypad.
Page 72 Use or Function Section 1 System Components Tower Cover The Tower Cover on the SL model, although not part of the Sample Loader, has an Interlock Sensor Switch which prevents the loader from operating if the cover is not in place. If the cover is removed during operation, the Sample Loader comes to an immediate halt, causing a fatal fault.
Page 73 The Printer is discussed in detail in Section 12: Printers. Reagent System Introduction The Reagent System is formulated specifically for the CELL-DYN 3200 Series instrument flow systems in order to provide optimal system performance. Use of reagents other than those specified in this manual is not recommended as instrument performance can be affected.
Page 74 RBC: 0.02 x M/µL HGB: 0.10 x g/dL PLT: 5.0 x K/µL CELL-DYN 3200 CN-Free HGB/NOC Lyse (List Number 03H80-02) CELL-DYN CN-Free HGB/NOC Lyse is formulated to meet the following requirements: • Rapidly lyse the red blood cells and minimize the resultant stroma •...
Page 75 (List Number 03H40-01) CELL-DYN Reticulocyte Reagent is formulated specifically to provide optimal system performance for the CELL-DYN 3200 Reticulocyte procedure. Use of reagents other than those specified in this manual is not recommended because instrument performance can be affected. Each CELL-DYN 3200 System is checked at the factory using the specified reagents and all performance claims were generated using these reagents.
Page 76 Use or Function Section 1 System Components NOTES 1-28 CELL-DYN ® 3200 System Operator’s Manual 9140181H—October 2001...
Page 77 Section 2 Installation Procedures and Special Requirements Overview Installation of the CELL-DYN 3200 should be performed by an authorized Abbott representative to ensure that all system components are functioning correctly and to verify system performance. NOTE: Installation of the Analyzer by an unauthorized or untrained person could result in damage to the system.
Page 78 The calibrator and controls needed for the installation are shipped when the instrument is shipped. This shipment includes: CELL-DYN Calibrator and Tri-level Control. If any reagents, calibrator or control materials are missing, contact the Abbott Hematology Customer Support Center for assistance. CELL-DYN ®...
Page 79 Section 2 Installation Procedures and Special Requirements Space Requirements Approximately 6 linear feet of space is required on the counter top to accommodate the instrument, display station, and printer. Sufficient space is required beneath for the reagents and the waste container (if one is used). Do not position the instrument so that it is difficult to operate the main power switch.
Page 80 Installation Procedures and Special Requirements Section 2 Overview Power Requirements Be sure that the system is located at the desired site before attempting any connections. A minimum of three power outlets are required for either model: one outlet for the Analyzer, one for the Printer, and one for the Display Station. If a Ticket Printer will also be installed, a fourth power outlet will be needed.
Page 81 Section 2 Installation Procedures and Special Requirements Tubing Installation Reagent and Waste Tubing 1. Locate the reagent tubing in the Accessory Kit. 2. Inspect each length of tubing carefully for damage or cracks. 3. Attach the non-weighted end of the tubing with the Purple WBC Lyse label to the Purple Connector on the right side of the Rear Panel.
Page 82 Installation Procedures and Special Requirements Section 2 Tubing Installation 1 Waste Full Sensor 2 Waste Outlet Connector 3 HGB Lyse Connector 4 Diluent/Sheath Connector 5 WBC Lyse Connector Figure 2.1 Reagent Inlet Panel 7. Locate the Waste-Full Sensor Plug attached to the cap's electrode wires. Insert the plug into the :DVWH 6HQVRU connector located on the Reagent Inlet Panel.
Page 83 Section 2 Installation Procedures and Special Requirements 1 Left Front Cover 2 Right Front Cover 3 Touch Plate 4 Phillips-head Screws 5 Sample Loader 6 Tower Cover Figure 2.2 Analyzer Front Covers — SL Model Open Left Front Cover To open the Left Front Cover on both the SL and CS models, gently pull on the hand hold to release it.
Page 84 Installation Procedures and Special Requirements Section 2 Tubing Installation Remove Sample Loader To access the Flow Panel, the Sample Loader on the SL Model is pulled away from the analyzer as follows: 1. Remove Tower Cover. 2. Open Left and Right Front Covers as follows. Gently pull on cover using hand hold and swing door open about 30-45 degrees.
Page 85 Section 2 Installation Procedures and Special Requirements 5. Carefully lift and pull the Sample Loader away from the instrument approximately 2-3 inches. 6. Push the Sample Loader down to lock it into place. Tubing Installation NOTE: The tubing must be installed before the power is turned ON for the instrument to operate correctly.
Page 86 1. Inspect the Flow Panel components for obvious damage and to ensure the tubing is properly positioned under all solenoid pinch valves. 2. If there is any damage, contact the Abbott Hematology Customer Support Center. 3. When the inspection of the Flow Panel is completed, turn the Main Power Switch to ON.
Page 87 Basic installation procedures follow for the Ticket and Graphics Printers. When used with the CELL-DYN 3200, the Graphics Printer prints color or black-and- white graphic reports and the Ticket Printer prints tickets or black-and-white graphic reports.
Page 88 1 Graphics Printer Port 2 Ticket Printer Port Figure 2.7 CELL-DYN 3200 Printer Ports Graphics Printer Installation Procedure 1. Assemble the printer as directed in the printer manual. 2. Make sure that the printer power switch is OFF. Plug the power cord into the printer.
Page 89 Run any self-test printouts before using the printer for the first time. These self- tests may be run any time to verify proper printer operation. The CELL-DYN 3200 software automatically controls and adjusts most print IMPORTANT conditions for the Graphics Printer, including page width. If printing is not what you expect, refer to the printer manual for guidance in making adjustments.
Page 90 Installation Procedures and Special Requirements Section 2 Printer Installation Loading Individual Tickets in the Ticket Printer Instructions are given for loading individual tickets. If fanfold, continuous-feed tickets are used, they should be loaded as directed in the printer manual for tractor- feed paper.
Page 91 Section 2 Installation Procedures and Special Requirements Sample Loader Inspection (SL Model) The Sample Loader is attached directly to the Analyzer to form an integrated unit, as shown in Figure 2.8. Four screws, two on either side, hold the Sample Loader to the Analyzer. A power cord provides power from the Analyzer to the loader, and an interface cable allows communication between the Analyzer and loader.
Page 92 Installation Procedures and Special Requirements Section 2 Printer Installation To inspect the Sample Loader: 1. Unpack the instrument from its shipping container and place it on a flat surface. 2. Remove the protective plastic. 3. Inspect the Sample Loader for signs of obvious damage and verify the loader is securely attached to the Analyzer.
Page 93 Section 2 Installation Procedures and Special Requirements Power On 1. Turn the instrument’s Main Power Switch to ON. When the initialization process is complete, press the [RUN] key to prime the instrument. When the priming process is complete, the READY light on the Analyzer’s indicator panel is lit and the message READY is displayed in the Status Box on the monitor.
Page 94 Installation Procedures and Special Requirements Section 2 Printer Installation NOTES 2-18 CELL-DYN ® 3200 System Operator’s Manual 9140181H—October 2001...
Page 95 NOTE: An increase in flags will occur in RRBC and FWBC modes. Sample Aspiration There are two modes of whole blood sample aspiration on the CELL-DYN 3200. The operator selects the mode of aspiration from the RUN screen. • The Open Sampler Mode is used to aspirate the sample from a collection tube that has been opened and is held under the open sample aspiration probe.
Page 96 Principles of Operation Section 3 Overview NOTES CELL-DYN ® 3200 System Operator’s Manual 9140181H—October 2001...
Page 97 Section 3 Principles of Operation Sample Analysis Cycle Overview NOTE: Sample and reagent volumes given in this section are stated as the nominal values. Slight differences between instruments may cause these volumes to vary. These differences are compensated for by factory-set internal dilution factors.
Page 98 Principles of Operation Section 3 Sample Analysis Cycle Overview Hemoglobin Analysis 1. The Diluent/Sheath Syringe injects 1.7 mL of diluent through the Shear Valve where the 12 µL HGB volume is transferred to the HGB Flow Cell. 2. The HGB Lyse Syringe dispenses 0.9 mL of HGB Lyse into the line after the diluent has transferred the HGB volume to the HGB Flow Cell.
Page 99 Section 3 Principles of Operation Fragile WBCs and Resistant RBCs When running samples in the normal Patient mode, the operator may suspect the presence of fragile WBCs when the FWBC flag is displayed or may suspect the presence of resistant RBCs when the RRBC and NRBC flags are displayed. In the case of samples containing fragile WBCs or resistant RBCs, an alternate method is used to measure white blood cells.
Page 100 Principles of Operation Section 3 Sample Analysis Cycle Overview Results Displayed All data is transmitted to the Data Module for analysis. Results are computed for all parameters and are displayed on the RUN screen. Results are also stored in a log format called the Data Log.
Page 101 Principles of Operation Flow Cytometry Introduction to Flow Cytometry The CELL-DYN 3200 uses flow cytometric techniques to analyze the RBC/PLT, WBC, and NOC populations. This section gives a brief introduction to the principles of flow cytometry. Flow cytometry is a process in which individual cells or other biological particles in a single file produced by a fluid stream are passed through a beam of light.
Page 102 Principles of Operation Section 3 Flow Cytometry Detection with the Optical Bench The optical bench assembly contains the components that make up the flow cytometer. It is depicted in Figure 3.1. The main purpose of the optical bench is to detect the light scattered by the cells as they pass through the flow cell.
Page 103 Combining the information from the two scatter measurements provides more accurate discrimination between cell populations than either single measurement. (See Fig. 3.3 for an example of the light scatter measured by the CELL-DYN 3200.) CELL-DYN ® 3200 System Operator’s Manual...
Page 104 Principles of Operation Section 3 Flow Cytometry WBC Measurement Overview The Optical Channel is used for the determination of WBC data. During sample aspiration, 20 µL of sample is segmented in the Shear Valve for WBC measurement. The WBC Syringe dispenses 0.973 mL of WBC lyse to the Shear Valve.
Page 105 WBC Reagent The WBC reagent used with the CELL-DYN 3200 instrument is the CELL-DYN WBC Lyse. It is an integral part of the WBC analysis. White blood cells diluted in the reagent maintain cellular integrity close to their native state. The structure of the basophils changes slightly due to the hygroscopic nature of the basophilic granules.
Page 106 Principles of Operation Section 3 Flow Cytometry Mononuclear – Polymorphonuclear Mononuclear – Polymorphonuclear Separation Identification 10° Complexity 10° Complexity Figure 3.4 Mononuclear-Polymorphonuclear Scatter Mononuclear-Polymorphonuclear Separation The scatter information is plotted with the 90° scatter on the Y axis and the 10° scatter on the X axis.
Page 107 Section 3 Principles of Operation Neutrophil – Eosinophil Neutrophil – Eosinophil Separation Identification 90° Lobularity 90° Lobularity Figure 3.5 Neutrophil-Eosinophil Scatter Neutrophil-Eosinophil Separation The scatter information is plotted with the 90°D scatter on the Y axis and the 90° scatter on the X axis. (The 90°D/90° scatterplot is shown in Figure 3.5.) Only the polymorphonuclear cells are plotted on this scatterplot.
Page 108 Principles of Operation Section 3 Flow Cytometry Mononuclear Mononuclear Separation Identification 10° Complexity 10° Complexity Figure 3.6 Mononuclear Scatter Mononuclear Separation The scatter information is plotted with the 0° scatter on the Y axis and the 10° scatter on the X axis. (The 0°/10° scatterplot is shown in Figure 3.6.) The mononuclear cells are plotted on this scatterplot.
Page 109 Section 3 Principles of Operation Finally, the instrument evaluates the area below the lymphocyte cluster but above the hardware threshold (channel 23). Any particles that fall in this area are separated from the lymphocytes by a dynamic threshold. The following cell types may be present in this region: NRBCs Unlysed RBCs...
Page 110 Principles of Operation Section 3 Flow Cytometry Resistant RBC When a specimen containing resistant RBCs is run in the routine patient mode, the lytic agent in the WBC lyse reagent may be insufficient to lyse the “resistant” cells in the time allotted for the WBC count. Consequently, unlysed RBCs can be erroneously included in the WBC count resulting in a falsely elevated value.
Page 111 WBC Histograms Figure 3.7 WBC Histograms The CELL-DYN 3200 can present the WBC scatter information as two histograms: NWBC-LYM-MONO (N-L-M) and Mono-Poly (M-P). The NOC (Nuclear Optical Count) data can also be presented as a histogram. (Refer to Figure 3.7.) These histograms may be displayed and printed at the operator’s request.
Page 112 Principles of Operation Section 3 Flow Cytometry WBC Parameters Figure 3.8 WBC Data and Scatterplots The WBC data is generally displayed as depicted in Figure 3.8. All numeric and graphic data are automatically displayed on the RUN screen in the format selected. After the WBC scatter information has been plotted and the cells have been classified into the five subpopulations, the algorithms then determine the WBC and the percent of cells in each subpopulation.
Page 113 Section 3 Principles of Operation The WBC subpopulations are further identified by the following colors: Neutrophils — yellow Lymphocytes — blue Monocytes — purple Eosinophils — green Basophils — white NOTE: The basophils are displayed as white dots but appear as black dots on color printouts.
Page 114 Principles of Operation Section 3 Flow Cytometry RBC Parameters Figure 3.9 RBC Data and Histogram All numeric and frequency size distribution data are automatically displayed on the RUN screen in the format selected. The size distribution data for the red cells is displayed graphically as a histogram using 0°...
Page 115 Red Cell Distribution Width is a measure of the heterogeneity of the RBC population. The CELL-DYN 3200 reports a relative RDW equivalent to a CV in grams per deciliter. The RDW is derived from the RBC histogram using the 20th and 80th percentiles.
Page 116 Principles of Operation Section 3 Flow Cytometry PLT Count The PLT count is expressed as thousands per microliter (K/µL). Figure 3.10 PLT Data and Histogram The Mean Platelet Volume is derived from the PLT histogram after the PLT count has been determined. The MPV is expressed in femtoliters. The Plateletcrit is the product of PLT and MPV and is analogous to the hematocrit.
Page 117 Before the HGB is measured, a reference value is obtained using the CELL-DYN 3200 Diluent/Sheath in the HGB Flow Cell. A zero or blank reading is obtained on the diluent to provide a reference to which the sample signal is compared.
Page 118 Principles of Operation Section 3 Flow Cytometry Laboratory Worksheet Screen The LABORATORY WORKSHEET screen is provided to assist the laboratory staff in data review and validation (refer to Figure 3.11.) This screen is for laboratory use only. This screen displays the 5-Part Differential plus additional parameters.
Page 119 Section 3 Principles of Operation Table 3.1 5-Part Differential Parameter Results (K/µL) 11.15 5.91 3.16 MONO 2.06 0.02 BASO 0.00 Table 3.2 5-Part Differential Plus Additional Parameters Parameter Results (K/µL) 11.15 5.91 4.80 BAND 0.00 1.11 3.16 LYMe 2.01 VARL 1.15 MONO 2.06...
Page 120 Principles of Operation Section 3 Flow Cytometry NOTES 3-26 CELL-DYN ® 3200 System Operator’s Manual 9140181H—October 2001...
Page 121 Introduction Operational messages and data flags appear on the RUN screen, on printed reports and can be transmitted to a laboratory computer system. The CELL-DYN 3200 monitors instrument conditions and data criteria that may affect the displayed results and these messages and flags are used to alert the operator. Instructions for interpreting all flags, and numeric, scatter and histogram data should be incorporated into the laboratory’s procedure and used to determine the need for further action and/...
Page 122 Principles of Operation Section 3 Operational Messages and Data Flagging Cell Populations and Flagging Fragile WBCs Typically, fragile WBCs are abnormal lymphocytes that are present in chronic lymphocytic leukemia (CLL) and are the “smudge cells” that appear when the blood smear is made. When processing samples in the Patient mode (Patient is selected as the Specimen Type in the RUN screen), if fragile WBCs are present the WBC (WOC) count may be abnormally low due to the gradual destruction of the cytoplasmic membrane of...
Page 123 Section 3 Principles of Operation Parameter Flagging Messages Table 3.3 summarizes all of the parameter flagging messages by parameter and category. Table 3.3 Parameter Flagging Messages Suspect Suspect Interpretive Parameter Dispersional Data Alerts Parameter Flags Population Flags Messages Result displays in yellow if NWBC Leukopenia below lower limit...
Page 124 Principles of Operation Section 3 Operational Messages and Data Flagging Dispersional Data Alerts These alerts are triggered by the numeric limits entered into the six Patient Limit Sets (see Section 5: Operating Instructions; Subsection: Set Up Instructions for an explanation) or taken from the instrument’s preset linearity limits. If results for a parameter exceed these limits, they are flagged on the screen and on the report.
Page 125 Section 3 Principles of Operation Data Flagging Table 3.4 Specimen Modes Patient, QC, Resistant RBC Mode Flagging (when WOC and NOC are equivalent) Descriptor/Flag Cause Suggested Action NWBC 1) When stroma interference is >1.5% of Review smear for platelet clumps, giant analyzed events and there is no platelets or low levels of NRBCs and follow declining WOC kinetic rate.
Page 126 Principles of Operation Section 3 Operational Messages and Data Flagging Table 3.4 Specimen Modes (Continued) Patient, QC, Resistant RBC Mode Flagging (when WOC and NOC are equivalent) Descriptor/Flag Cause Suggested Action DFLT(NLMEB) One or more of the following conditions If the DFLT (NLMEB) flag is accompanied by are true: the FWBC flag, repeat in the FWBC mode.
Page 127 Section 3 Principles of Operation Table 3.4 Specimen Modes (Continued) Patient, QC, Resistant RBC Mode Flagging (when WOC and NOC are equivalent) Descriptor/Flag Cause Suggested Action BAND 1) The BAND flag is triggered if any of Review a stained smear for the presence of the following conditions are met: bands and follow your laboratory’s review criteria.
Page 128 Principles of Operation Section 3 Operational Messages and Data Flagging Table 3.4 Specimen Modes (Continued) Patient, QC, Resistant RBC Mode Flagging (when WOC and NOC are equivalent) Descriptor/Flag Cause Suggested Action 1) Interference in the lower threshold Repeat the specimen. If the flag persists, region (2fL–3fL) >...
Page 129 Section 3 Principles of Operation Table 3.4 Specimen Modes (Continued) Resistant RBC and QC Modes Descriptor/Flag Cause Suggested Action (NOC) WOC > NOC in the Resistant RBC cycle Review a stained smear to determine the cause of the interference (NRBC and/or (NOC is selected as WBC count.) unlysed RRBCs).
Page 130 Principles of Operation Section 3 Operational Messages and Data Flagging Interpretive Messages Interpretive messages appear only on the graphics report and are generated when the numeric limits entered in the Patient Limit Sets are exceeded. (see Section 5: Operating Instructions; Subsection: Set Up Instructions for an explanation). These messages are printed only when the Interpretive Report option is selected on the CUSTOMIZE REPORT SCREEN.
Page 131 Section 3 Principles of Operation References 1. ICSH, The Assignment of Values to Fresh Blood Used for Calibrating Automated Cell Counters, Clinical and Laboratory Hematology 1988, 10:203-212. 2. Clinical Applications of Flow Cytometry, ASCP National Meeting, Spring 1990. 3. Shapiro, Howard, Practical Flow Cytometry, 1984. 3-37 CELL-DYN ®...
Page 132 Principles of Operation Section 3 References NOTES 3-38 CELL-DYN ® 3200 System Operator’s Manual 9140181H—October 2001...
Page 133 Section 4 Performance Characteristics and Specifications Section 4 Performance Characteristics and Specifications Overview This section is a collection of detailed information about the CELL-DYN 3200 System. Included in this section are: • Physical Specifications • Operational Specifications • Bar Code Specifications •...
Page 134 Performance Characteristics and Specifications Section 4 Overview NOTES CELL-DYN ® 3200 System Operator’s Manual 9140181H—October 2001...
Page 135 Section 4 Performance Characteristics and Specifications System Specifications Physical Specifications Table 4.1 and Table 4.2 contain physical specifications for both the CELL-DYN 3200SL and CS models. Table 4.1 Instrument Dimensions Graphics Display Ticket Printer Printer Analyzer SL Analyzer CS Monitor (Dot Matrix) (Color Bubble Jet)
Page 136 Performance Characteristics and Specifications Section 4 System Specifications Power Specifications Table 4.3 shows the power requirements for both the CELL-DYN 3200 SL and CS models. Table 4.3 Power Specifications Analyzer Input Requirements Module Voltage Frequency Max Current BTU/Hr Analyzer 110 VAC ± 10% 50/60 ±...
Page 137 Section 4 Performance Characteristics and Specifications Operational Specifications Operating Environment Indoor Use Laboratory Temperature 15–30°C (59°–86°F) Relative Humidity 20–80%, RHNC Startup/Shutdown Times Auto-Startup (from STANDBY) Approximately 5.0 minutes Auto-Startup (from power OFF) Approximately 7.0 minutes* Shutdown (to STANDBY) 10 minutes * The laser requires a 15 minute warm up time.
Page 138 Performance Characteristics and Specifications Section 4 System Specifications Throughput Table 4.5 contains sample throughput information for the CELL-DYN 3200SL and Table 4.5 Sample Throughput (Patient Mode) CS Model Samples Per Hour Open Closed SL Model Samples Per Hour Open Closed NOTE: Maximum throughput may be achieved with normal samples that do not generate any instrument operational messages.
Page 139 Section 4 Performance Characteristics and Specifications Measurement Specifications — CELL-DYN 3200SL and CS Measurement Channels Laser optics for WBC and RBC/PLT Hemoglobin Absorbance Reticulocyte % WBC (WOC) Method Laser light scatter Light source Vertically polarized 5–10 mW helium-neon laser Wave length 632.8 nm Dilution 1:50 of blood in WBC lyse...
Page 140 Performance Characteristics and Specifications Section 4 System Specifications Retic Method Laser light scatter of cells stained with New Methylene Blue Light source Vertically polarized 5–10 mW helium-neon laser Wave length 632.8 nm Dilution 1:50 of stained blood in WBC Lyse Data Collection Three angles measured: 0°, 10°...
Page 141 Section 4 Performance Characteristics and Specifications Performance Specifications Background Counts Background counts for the following parameters are acceptable up to the limits listed: WOC <0.10 K/µL <0.10 K/µL <0.02 M/µL <0.10 g/dL <5.0 K/µL RETIC <100 counts/count cycle Carryover Carryover is the degree of influence the previous sample has on the next sample and is expressed as a percent.
Page 142 Performance Characteristics and Specifications Section 4 Performance Specifications Reticulocyte % measurement carryover, as shown in Table 4.7, is calculated using actual Listmode counts, rather than using the Reticulocyte percent. It is calculated using the following formula: Background Background % Carryover = X 100 Retic Listmode - Background Count...
Page 143 Section 4 Performance Characteristics and Specifications Hemogram Parameters Precision specifications for the hemogram parameters are presented using coefficient of variation (CV). The stated CV% in the following Table represents the instrument precision at a 95% confidence level from N = 20 replicate runs based on the same sample. Table 4.8 Precision of the Hemogram Parameters (N = 20) Parameter...
Page 144 Performance Characteristics and Specifications Section 4 Performance Specifications Table 4.9 Precision of the WBC Differential Parameters (N=20) Parameter Specimen Range % 95% Confidence Limit Neutrophil % 46–75 ± 2.2 Lymphocyte % 20–45 ± 2.8 Monocyte % 3.5–11.5 ± 2.7 Eosinophil % 0.5–8.0 ±...
Page 145 It should be noted that the reference diameters of the latex particles were calculated by the manufacturer using electronic impedance volume analysis. The optical analysis on the CELL-DYN 3200 is sensitive to the refractive index of the latex particles and although the relationship is linear, a regression through zero is not possible.
Page 146 Performance Characteristics and Specifications Section 4 Performance Specifications WBC Differential Parameters Table 4.12 Accuracy of WBC Differential Parameters Parameter Correlation Coefficient Neutrophil # and % > 0.95 Lymphocyte # and % > 0.94 Monocyte # and % > 0.86 Eosinophil # and % >...
Page 147 NOTE: N=20 is based on one whole blood sample aliquotted into 4 tubes, with each tube run 5 times. The data was obtained from several CELL-DYN 3200 systems over a period of weeks. These precision values represent the typical performance from instruments that are maintained properly, are operating in acceptable environmental conditions and are using only recommended reagents and supplies.
Page 148 Standard: “Reference Leukocyte Differential Count (Proportional) and Evaluation of Instrumental Methods” as a guideline. The statistics were determined by comparing the CELL-DYN 3200 System results with results obtained from a reference CELL-DYN 3500 System. Discrepant results were arbitrated with a manual, microscopic, 400-cell differential count.
Page 149 Section 4 Performance Characteristics and Specifications Abnormalities The following tables present a list of abnormalities targeted during this evaluation and the resultant data. Table 4.16 lists the various types of specimens that the sites attempted to collect during this evaluation: Table 4.16 Abnormalities 1.
Page 150 False Positives 3.19% False Negatives = 0.53% Specificity 96.81% Sensitivity 99.47% Table 4.18 shows the manual differential and CELL-DYN 3200 differential for false negative results. Table 4.18 Analysis of False Negative Results Manual Differential CELL-DYN 3200 Morphological False 2.5% Immature grans...
Page 151 Section 4 Performance Characteristics and Specifications Sample Loader Specifications Sample Loader Physical Specifications The Sample Loader attaches to the front of the CELL-DYN 3200SL Analyzer and is an integral part of the SL model. Table 4.19 contains the physical specifications for the Sample Loader.
Page 152 Performance Characteristics and Specifications Section 4 Sample Loader Specifications Sample Loader Operational Specifications Operational specifications for the Sample Loader are given in Table 4.20. Table 4.20 Sample Loader Operational Specifications Feature Specification Rack Capacity 5 racks on the load side; 5 racks on the unload side Tube Capacity 50 (10 tubes per rack)
Page 153 Section 5 Operating Instructions Section 5 Operating Instructions Overview This section, which discusses the operation of the CELL-DYN 3200, is divided into eight major subsections: Data Module Program Overview Software Flowcharts Set Up Instructions Specimen Collection and Handling Routine Operation...
Page 154 Operating Instructions Section 5 Overview NOTES CELL-DYN ® 3200 System Operator’s Manual 9140181H—October 2001...
Page 155 Section 5 Operating Instructions Data Module Program Overview The Data Module menus are presented as key labels displayed across the bottom of the screen. Each menu is accessed by pressing the soft key located directly below the label. From left to right, these soft keys correspond to keys F1–F8 on the standard computer keyboard.
Page 156 Operating Instructions Section 5 Data Module Program Overview Feb 23, 2001 Figure 5.1 Main Menu Screen NOTE: The cursor is positioned at the <Operator ID> field when the MAIN MENU screen is displayed. An operator ID of up to three alphanumeric characters may be entered.
Page 157 Section 5 Operating Instructions Software Flowcharts Flowchart Conventions Menus are shown as square-cornered rectangles in the flowcharts, and soft keys are shown as round-cornered rectangles: MAIN MENU SET UP DATA LOG RETIC QUALITY CALIBRA- DIAG- SPECIAL DATA LOG CONTROL TION NOSTICS PROTOCOLS Soft keys are also depicted as follows in flowcharts:...
Page 158 Operating Instructions Section 5 Software Flowcharts Set Up Menu Flowchart SET UP MENU DATE/ LIMIT PATIENT QC SET UP OPERATION UNITS CUSTOMIZE REAGENT MAIN SET 1 TIME SELECTION REPORT LIMITS MENU SET UP LIMIT LIMIT LIMIT PRINT RETURN LIMIT LIMIT SET 2 SET 3 SET 4...
Page 159 Section 5 Operating Instructions Run Menu Flowchart START WORK SPECIMEN CUSTOMIZE CHANGE PRINT PRINT MAIN LOADER LIST TYPE REPORT SAMPLER TICKET REPORT CLEAR COLOR FAULT PRINT see CUSTOMIZE REPORT PRIME on SET UP MENU STOP LOADER PATIENT BACK- FRAGILE LATEX RESISTANT RETURN SPECIMEN...
Page 160 Operating Instructions Section 5 Software Flowcharts Quality Control Menu Flowchart QC MENU Ready SET UP CUSTOMIZE VIEW CUSTOMIZE MAIN FILE SET UP QC LOG LIMITS QC FILE DISPLAY PRINTOUT TURN X-B PRINT RETURN TURN X-B WBC ON RBC ON RETURN SELECT CANCEL STANDARD...
Page 161 Section 5 Operating Instructions Calibration Menu Flowchart CALIBRATION Ready ENTER CALIBRATION AUTO CLOSED PRINT MAIN FACTOR CALIBRATE SAMPLER OPEN SAMPLER RESTORE RESET ALL RETURN FACTORS TO 1.000 *WHOLE *CALIBRATOR PRINT RETURN BLOOD CLOSED PRINT RETURN SAMPLER OPEN SAMPLER RETURN QUIT START AUTO-CAL CONFIRM...
Page 162 Operating Instructions Section 5 Software Flowcharts Diagnostics Menu Flowcharts DIAGNOSTICS MENU Ready FAULT EXECUTION CNT RATE CLEAR RAW DATA MORE MAIN REPORT TIMES SUMMARY FAULTS SUMMARY RBC/PLT PRINT RETURN CNT RATE CNT RATE CNT RATE RBC/PLT CNT GRAPH CNT GRAPH CNT GRAPH RBC/PLT CNT DATA...
Page 163 Section 5 Operating Instructions Diagnostics Menu Flowchart (continued) DIAGNOSTICS MORE MORE MORE RBC LIN DATA DATA DATA DATA DATA RBC 0 RBC 10 RBC 90 SMOOTHING PRINT DIAGNOSTICS DATA DATA DATA ON/OFF RBC 0 RBC 10 RBC 90 HISTOGRAM HISTOGRAM HISTOGRAM PLT 0 PLT 10...
Page 164 Operating Instructions Section 5 Software Flowcharts Special Protocols Flowchart SPECIAL PROTOCOLS CLEAR REAGENT EMPTY/FILL CLEAN/RES DISABLE/ENAB MORE MAIN FAULT SHEAR VALVE RESERVOIR FLOW CELL ANALYZER DISABLE RETURN ANALYZER EMPTY RETURN FLOW CELL ENABLE EMPTY EMPTY EMPTY RETURN ANALYZER DIL/SHEATH HGB LYSE WBC LYSE FILL FLOW CELL...
Page 165 Section 5 Operating Instructions Set Up Instructions This section discusses the options available when the [SET UP] key is pressed. (See Figure 5.2.) These options are used to configure the system according to the laboratory’s requirements. The function of each key is discussed and set up procedures are given where applicable.
Page 166 Operating Instructions Section 5 Set Up Instructions Figure 5.3 Date/Time Set Up Screen Date/Time The [DATE/TIME] key is used to enter the date and time. This screen allows the operator to select the format for displaying the date and to change the date and time as required.
Page 167 Section 5 Operating Instructions To Set Date/Time 1. From the SET UP MENU screen, press [DATE/TIME] to display the DATE/TIME SET UP screen. 2. Type the number of the desired format at the cursor. 3. Press the Enter key on the keyboard to save the entry and advance to the DATE entry field.
Page 168 Operating Instructions Section 5 Set Up Instructions Patient Limits The [PATIENT LIMITS] key is used to enter upper and lower flagging limits for groups of patient samples. (For example, limits may be entered for adult males, adult females, neonates, etc.) The following soft key labels are displayed (See Figure 5.4.) when the [PATIENT LIMITS] key is pressed: LIMIT SET 1 LIMIT SET 2...
Page 169 Section 5 Operating Instructions Patient age is entered in Weeks and/or Years. The range for Weeks is zero to 51. The range for Years is 1 to 199. Any number input shall be interpreted by the system as “equal to or less than.” Age ranges are automatically established by using successively higher numbers.
Page 170 Operating Instructions Section 5 Set Up Instructions Figure 5.5 Diluent/Sheath Log Screen Reagent Log The [REAGENT LOG] key is used to enter current reagent information into the three reagent logs. The following soft key labels are displayed when the [REAGENT LOG] key is pressed: DELETE ENTRY DIL/SHEATH LOG...
Page 171 Section 5 Operating Instructions To Complete Reagent Log Entry 1. Press [REAGENT LOG] to display a REAGENT LOG screen. 2. If the desired reagent log is not already displayed, use the soft key to select the appropriate log. 3. Use the arrow keys on the keyboard to move the cursor to the desired entry field.
Page 172 To Delete Entries When the log is full (the log holds 10 entries), the oldest entry must be deleted to create space for a new entry. Abbott suggests that, for documentation purposes, the log be printed when it is full.
Page 173 Section 5 Operating Instructions QC Set Up Menu The [QC SET UP MENU] key is used to display a list of the QC files (see Figure 5.6) and the following soft key labels: X-B SET UP LAB ID SET UP QC LIMITS SET UP QC FILE CUSTOMIZE DISPLAY...
Page 174 Operating Instructions Section 5 Set Up Instructions X-B Setup Menu The [X-B SET UP] key is used to select the X-B SET UP screen. (See Figure 5.7.) This screen is used to enter upper and lower acceptance limits, target values, and action limits for the X-B Moving Average QC Program for both the WBC and RBC parameters.
Page 175 Section 5 Operating Instructions Lab ID Set Up The [LAB ID SET UP] key on the QC Set Up Menu is used to enter Laboratory Identification information for the QC files. This information is necessary for participants in the CELL-DYN Interlaboratory QC Program who wish to submit their results on a floppy disk.
Page 176 Operating Instructions Section 5 Set Up Instructions Figure 5.8 QC Means/Limits Entry Screen Means/Limits Entry 1. Select a file from the QC SET UP MENU screen by using the Arrow keys on the keyboard to move the cursor into the desired file. 2.
Page 177 Section 5 Operating Instructions Figure 5.9 QC Range Entry Screen Range Entry 1. Select a file from the QC SET UP screen by using the Arrow keys on the keyboard to move the cursor into the desired file. 2. Press [QC LIMITS] to display the QC RANGE ENTRY screen for the selected file. 3.
Page 178 Operating Instructions Section 5 Set Up Instructions Update From File Figure 5.10 Update From File The [UPDATE FROM FILE] key is displayed on the QC MEANS/LIMITS ENTRY and QC RANGE ENTRY screens when there are two or more results in the file. (See Figure 5.10.) When the [UPDATE FROM FILE] key is pressed, the bulletin line displays the message USE CONFIRM UPDATE TO SET MEANS AND LIMITS FROM QC FILE and the following soft key labels are displayed:...
Page 179 Section 5 Operating Instructions Procedure: Load From Disk 1. Press [QUALITY CONTROL] to display a list of QC files. 2. Use the arrow keys on the keyboard to move the cursor to the desired file. Type the file name (e.g., Low L0036) and press the Enter key on the keyboard to save the name and advance the cursor to the next file.
Page 180 Operating Instructions Section 5 Set Up Instructions Set Up QC File The [SET UP QC FILE] key is used to configure the QC file. If the file is used for a commercial control, the lot number and expiration date may be entered by pressing the [LOT NUMBER] key.
Page 181 Section 5 Operating Instructions QC File Set Up 1. Press [QC SET UP MENU] to display the QC SET UP MENU screen. 2. Use the Arrow keys on the keyboard to move the cursor to the desired QC file. 3. Type the desired alphanumeric file name. (Up to 12 characters may be entered.) 4.
Page 182 Operating Instructions Section 5 Set Up Instructions To Enter Lot Number Data 1. If necessary, from the QC FILE SET UP screen, press [LOT NUMBER] to display the <Lot Number> and <Expiration Date> entry fields. 2. The cursor is in the <Lot Number> entry field. Type the lot number and press the Enter key on the keyboard to save the entry and advance the cursor to the <Expiration Date>...
Page 183 Section 5 Operating Instructions To Enter Replicate ID Data 1. If necessary, from the QC FILE SET UP screen, press [REPLICATE ID] to display the <Replicate Id! entry field. 2. The cursor is in the <Replicate ID> entry field. Type the sample ID number (up to 12 alphanumeric characters may be entered) and press the Enter key on the keyboard to save the entry and advance the cursor to the <Westgard Rule Selection>...
Page 184 Operating Instructions Section 5 Set Up Instructions Figure 5.13 Customize QC Display Screen Figure 5.14 Customize QC Display Screen Showing Standard Groups 5-32 CELL-DYN ® 3200 System Operator’s Manual 9140181H—October 2001...
Page 185 Section 5 Operating Instructions To Customize QC Log Display 1. Select a file from the QC SET UP menu screen by moving the cursor to the desired file. 2. Press [CUSTOMIZE DISPLAY] to display the CUSTOMIZE QC DISPLAY screen for the selected file. 3.
Page 186 9. Repeat this procedure to select standard groups for other QC logs. Latex Set This key is intended to be used by Abbott Service personnel only. If the [LATEX SET] key is pressed, parameters in all groups will be affected. The [LATEX SET] key is available from the CUSTOMIZE QC DISPLAY screen for Standard Groups.
Page 187 Section 5 Operating Instructions Figure 5.15 Customize QC Printout Screen Customize Printout The [CUSTOMIZE PRINTOUT] key in the QC SET UP menu is used to customize the printout format for the QC logs. (See Figure 5.15.) The following soft key labels are displayed when the [CUSTOMIZE PRINTOUT] key is pressed: SELECT PARAMETER (Toggles to PLACE PARAMETER when pressed)
Page 188 Operating Instructions Section 5 Set Up Instructions 4. Press [SELECT PARAMETER]. The selected parameter is highlighted and the cursor moves to the first position in the group. NOTE: The key label changes to [PLACE PARAMETER] and a [CANCEL SELECTION] key is displayed. 5.
Page 189 Section 5 Operating Instructions Operation Set Up Menu The OPERATION SET UP MENU screen (see Figure 5.16) allows the operator to select screen colors, the type of bar code used, and to configure the transmission to an on-line (host) computer. The following soft key labels are displayed when the [OPERATION SET UP] key is pressed: TURN ON RETIC PKG LANGUAGE...
Page 190 Operating Instructions Section 5 Set Up Instructions The following soft keys are displayed when the [LANGUAGE] key is pressed: ENGLISH XVHG WR UHWXUQ WR WKH GHIDXOW ODQJXDJH English (name of currently displayed language) NEXT LANGUAGE RETURN Pressing the capitalized [ENGLISH] soft key allows the operator to return to English which is the default language.
Page 191 Section 5 Operating Instructions Figure 5.18 Select Color Screen Select Color The SELECT COLOR screen, shown in Figure 5.18, allows the user to select various colors for displaying parameter data and other information on the screen. The following soft keys are displayed when the [SELECT COLOR] key is pressed: RESTORE PREVIOUS RESTORE DEFAULT RETURN...
Page 192 Operating Instructions Section 5 Set Up Instructions To Change Color Settings 1. Press [SELECT COLOR] in the OPERATION SET UP MENU. 2. Use the Arrow keys on the keyboard to move the cursor to the desired location in either the Foreground or Background columns. 3.
Page 193 Section 5 Operating Instructions Figure 5.19 Bar Code Set Up Screen Bar Code Set Up The [BAR CODE SET UP] key is used to select the type of bar code to be read and to enable or disable the check digit option for the selected bar code. (See Figure 5.19.) NOTE: For more information about check digits and bar codes, refer to Appendix A, Bar Codes.
Page 194 Information System) using a direct serial link. Data may be transmitted automatically as each sample is run or at the operator’s request. The CELL-DYN 3200 also can receive patient information transmitted to it by the on-line computer. The COMPUTER SET UP screen is used to configure the transmission format to meet the requirements of the Laboratory Information System or on-line computer.
Page 195 Section 5 Operating Instructions Stop Transmiss The [STOP TRANSMISS] key is used to terminate the current data transmission to an on-line computer. When the [STOP TRANSMISS] key is pressed, the following soft key labels are displayed: CONFIRM STOP CANCEL STOP Pressing [CONFIRM STOP] causes the transmission to terminate.
Page 196 Operating Instructions Section 5 Set Up Instructions NOTE: Auto-transmitting extended data uses CPU time during the acquisition cycle. In order to reduce the time taken by this transmission, auto- transmission of extended data is only allowed at the baud rates of 38400 and 56000.
Page 197 Section 5 Operating Instructions Figure 5.21 Units Selection Screen Units Selection Menu The [UNITS SELECTION] key selects the report units for the indicated parameters. Units may be selected for each parameter individually or a set of units may be selected by pressing the appropriate soft key. (See Figure 5.21.) The following soft key labels are displayed when the [UNITS SELECTION] key is pressed: USA UNITS SI UNITS...
Page 198 Operating Instructions Section 5 Set Up Instructions Table 5.1 Report Units SI MOD SET1 SET2 Parameter Value Units Value Units Value Units Value Units Value Units WBC* 5.32 K/µL 5.32 5.32 10e9/L 5.32 10e3/µL 53.2 10e2/µL 5.15 M/µL 5.15 5.15 10e12/L 5.15 10e6/µL...
Page 199 Section 5 Operating Instructions Customize Report The [CUSTOMIZE REPORT] key is used to customize displayed and/or printed reports. When the [CUSTOMIZE REPORT] key is pressed, the screen that was displayed last will appear (Graphics Printer is the default screen). Customize Printout The [CUSTOMIZE PRINTOUT] key is used to customize the printout for the Graphics Printer and the Ticket Printer.
Page 200 Operating Instructions Section 5 Set Up Instructions Figure 5.22 Customize Printed Report Screen for the Graphics Printer Graphics Printer When the [GRAPHICS PRINTER] key is pressed, the CUSTOMIZE PRINTED REPORT screen for the Graphics Printer is displayed. (See Figure 5.22.) A description of the options available on the CUSTOMIZE PRINTED REPORT screen is given below: 1.
Page 201 12. COLOR PRINTING When this option is enabled, a color printout can be obtained on the CELL-DYN 3200 by pressing the [COLOR PRINT] key. To Customize the Graphics Report 1. Go to the Graphics Printer set up section of the CUSTOMIZE PRINTED REPORT screen (refer to Figure 5.22).
Page 202 Operating Instructions Section 5 Set Up Instructions Figure 5.23 Customize Printout Header Screen for the Graphics Report Customize Header The [CUSTOMIZE HEADER] key is used to customize the header for the graphics report. (See Figure 5.23.) Any report printed in a graphics format will be printed with this header.
Page 203 Section 5 Operating Instructions To Customize the Graphics Header 1. From any CUSTOMIZE PRINTED REPORT screen, press [CUSTOMIZE HEADER] to display the CUSTOMIZE PRINTOUT HEADER screen. Use the Arrow keys to skip a field. 2. Type the desired number of lines for the header in the indicated field. The header can include up to four lines.
Page 204 Operating Instructions Section 5 Set Up Instructions Figure 5.24 Customize Printed Report Screen for Blank Tickets Blank Ticket When the [BLANK TICKET] key is pressed, the CUSTOMIZE PRINTED REPORT screen for blank tickets is displayed. The following options are available: 1.
Page 205 Section 5 Operating Instructions 5. PRINT LIMITS REPORT When this option is enabled, the Patient Limits set that was applied to the results is printed on the report. 6. PRINT SPECIFIC ALERTS When this option is enabled, the specific flag (BANDS, LRI, etc.) replaces the “AL”...
Page 206 Operating Instructions Section 5 Set Up Instructions NOTE: The number of lines of data in the header box cannot exceed the number of lines entered in step 8 above. For example, if 1 were input, then a maximum of 1 line will be accepted in the header box. The operator may type in 2 lines of data, but only the first line will be saved when the operator exists this screen.
Page 207 Section 5 Operating Instructions 2. AUTO-PRINT RESULTS FOR ALERTED SPECIMENS When this option is enabled, results for flagged specimens are automatically printed as tickets are inserted in the printer. Flagged results are marked with an asterisk (*). 3. AUTO-PRINT RESULTS FOR NON-ALERTED SPECIMENS When this option is enabled, results for specimens that are not flagged are automatically printed as tickets are inserted in the printer.
Page 208 Operating Instructions Section 5 Set Up Instructions Figure 5.26 Customize Displayed Report Screen The screen is divided into two sections. Individual parameters are listed in the left section and the scatterplots and histograms are listed in the right section. Parameter Sets Using the [PARAM SET “X”] key, the display may be customized for four different sets of parameters.
Page 209 Section 5 Operating Instructions To Customize the Display Screen 1. From the SET UP MENU screen, press [CUSTOMIZE REPORT] and if necessary, press [CUSTOMIZE DISPLAY] to display a parameter set. 2. If desired, press [PARAM SET “X”] to select a different parameter set. 3.
Page 210 Operating Instructions Section 5 Set Up Instructions Interpretive Report Messages If the PRINT INTERPRETIVE REPORT option on the CUSTOMIZE PRINTED REPORT screen for the Graphics Printer is enabled, Interpretive Report messages are printed on the report. Some of these messages are generated from the information entered for the Patient Limits.
Page 211 Daily Shutdown Procedure Unless stated otherwise, all subsections apply to both the Sample Loader and Closed Sampler versions of the CELL-DYN 3200. For convenience, instructions for running samples in the Open Mode are repeated in each of the two Running Samples subsections.
Page 212 Operating Instructions Section 5 Routine Operation To power-up the instrument: 1. Verify that all components are properly installed (syringes, tubing in the normally closed valves, Shear Valve, etc.). 2. Verify that all reagents are properly installed. 3. Verify that all necessary cables and power cords are properly connected. 4.
Page 213 Section 5 Operating Instructions Operating the Instrument Activating The RUN Cycle On the CS model, start the RUN cycle for either the Open or Closed Mode by pressing the Touch Plate. NOTE: The door Assembly must be closed for the Closed Mode RUN cycle to be activated.
Page 214 Operating Instructions Section 5 Routine Operation Power OFF Procedure It is not necessary to turn the system OFF under normal operating conditions. The system should be turned OFF when certain maintenance procedures will be performed, when the system will be moved, or when the system will be inactive for an extended period of time (longer than 2 weeks).
Page 215 Section 5 Operating Instructions Start-Up Procedure To startup the instrument, do the following: 1. If the instrument is OFF, first turn the power ON. When INITIALIZED is displayed in the MAIN MENU Status Box, press [RUN] to prime the instrument and bring it to the READY state.
Page 216 Operating Instructions Section 5 Start-Up Procedure NOTES 5-64 CELL-DYN ® 3200 System Operator’s Manual 9140181H—October 2001...
Page 217 Section 5 Operating Instructions Run Menu The RUN menu and its sub-menus are described below, including soft keys, demographics area, Work List, and bulletin line. To display the RUN menu, press [RUN] in the MAIN MENU. If the instrument has not been primed, the priming cycle occurs before the RUN menu is displayed.
Page 218 Operating Instructions Section 5 Run Menu Fragile WBC and Resistant RBC If the specimen type selected is FRAGILE WBC, then the label “FrgWBC” appears instead of “Name” in the Demographics Section. If the specimen type selected is RESISTANT RBC, then the label “ResRBC” appears instead of “Name” in the Demographics Section.
Page 219 Section 5 Operating Instructions Center Section The Center Section of the RUN screen displays the results. A list of the parameters and results is displayed on the left side. Scatterplots and histograms are displayed on the right side. The area between the parameter data and the graphic data is used to display flagging messages.
Page 220 Operating Instructions Section 5 Run Menu PRINT REPORT/ (This key label changes to &2/25 35,17 when COLOR PRINT the color printing option is selected in the &86720,=(' 35,17(' 5(3257 screen for the Graphics Printer) MAIN SL Model Figure 5.28 Run Screen for Patient Samples - SL Model The soft keys shown on the SL model are similar to the CS model except for the first key (leftmost key label on the screen) in Closed Mode, shown below, which is used to operate the Sample Loader.
Page 221 Section 5 Operating Instructions Clear Fault The blank key label in the CS model or the [START/STOP LOADER] key label in the SL model changes to [CLEAR FAULT] whenever a system fault occurs (e.g., Diluent Empty). This key is used to clear the fault message and return the Analyzer to the READY state after corrective action has been taken.
Page 222 Operating Instructions Section 5 Run Menu Figure 5.30 Work List Screen - Page 2 The Work List is used to pre-assign sample identification, display and print criteria for samples that will be run. It is essentially a list of samples (including the pre- assigned information) that the operator intends to run on the instrument.
Page 223 Section 5 Operating Instructions Specimen Type Figure 5.31 Specimen Type Screen The [SPECIMEN TYPE] key is used to select the type of specimen that will be run. (See Figure 5.31.) When the [SPECIMEN TYPE] key is pressed, the screen displays a list of the QC files and the following soft key labels: PATIENT QC SPECIMEN...
Page 224 Operating Instructions Section 5 Run Menu Patient Figure 5.32 Run Screen Showing Patient Results The [PATIENT] key is used to display the RUN screen for patient samples. (See Figure 5.32.) Patient identification and demographics may be entered on the RUN screen after this key is pressed.
Page 225 Section 5 Operating Instructions QC Specimen Figure 5.33 Run Screen for a QC File This key is used to select a QC file designated by the position of the cursor on the screen. (Refer to Figure 5.31 for a display of QC files). After the cursor is moved to the desired file, the [QC SPECIMEN] key is pressed to display the 581 screen for the selected file.
Page 226 Operating Instructions Section 5 Run Menu Background Figure 5.34 Run Screen for Background Counts The [BACKGROUND] key is used to select the run mode and display the RUN screen for background counts. (Refer to Figure 5.34.) Results from this run option are identified by the designation %$&.*5281' in the Data Log and are automatically excluded from the X-B analysis.
Page 227 Section 5 Operating Instructions Fragile WBC Figure 5.35 Run Screen for Fragile WBC Counts The [FRAGILE WBC] key is used to select the Fragile WBC specimen type. This cycle is used to obtain an accurate WBC count for samples containing fragile WBCs.
Page 228 The [LATEX] key is used to select the run mode for latex particles and display the RUN screen for them. The LATEX screen is similar to the QC FILE screen, except that “Latex” replaces the QC File name in the Demographics Section. This key is for use by Abbott service personnel only. 5-76 CELL-DYN ®...
Page 229 Section 5 Operating Instructions Resistant RBC Figure 5.37 Run Screen for Resistant RBC Counts The [RESISTANT RBC] key is used to select the Resistant RBC specimen type. This cycle is used to process samples containing RBCs that are resistant to lysis. The sample is held in the WBC Mixing Chamber for approximately 15 seconds longer than the normal mixing time.
Page 230 Operating Instructions Section 5 Run Menu Customize Report The [CUSTOMIZE REPORT] key is discussed in the Set Up Instructions earlier in this section. Change Sampler The [CHANGE SAMPLER] key is used to select the Open or Closed Mode of operation. When the key is pressed, the mode changes from the mode currently selected to the other operating mode.
Page 231 Section 5 Operating Instructions Additional Examples of Run Menu Screens Flagging Messages An example of some flagging messages is shown in Figure 5.38. A detailed explanation of all flagging messages is given in Section 3: Principles of Operation. Figure 5.38 Display Specimen Screen Showing Flagging Messages and RBC MORPH Message 5-79 CELL-DYN...
Page 232 Operating Instructions Section 5 Run Menu Bulletin Line Messages Bulletin Line messages alert the operator to problems with the instrument or provide instructions. An example of a Bulletin Line message reading “Ticket printer unavailable” is shown in Figure 5.39. Figure 5.39 Display Specimen Screen Showing Bulletin Line Message 5-80 CELL-DYN ®...
Page 233 Section 5 Operating Instructions Laboratory Worksheet To display the LABORATORY WORKSHEET screen, press the Page Down key on the keyboard while the RUN menu is displayed or while the DISPLAY SPECIMEN screen in the DATA LOG menu is displayed. The LABORATORY WORKSHEET screen displays additional parameters as shown in Figure 5.40.
Page 234 Operating Instructions Section 5 Run Menu NOTES 5-82 CELL-DYN ® 3200 System Operator’s Manual 9140181H—October 2001...
Page 235 Section 5 Operating Instructions Sample Collection and Handling Anticoagulant All performance claims given in this manual were generated from samples collected in K EDTA. Sample Stability Any refrigerator-stored specimens should be brought to room temperature before processing. If specimens are to be run within eight hours after collection, storage at room temperature is recommended.
Page 236 Section 5 Sample Collection and Handling Interfering Substances The CELL-DYN 3200 has been designed to detect and flag samples that contain interfering substances. The following list indicates the substances that may interfere with the listed parameters. WBC: NRBCs, lytic-resistant RBCs, PLT clumps, cryoglobulin and...
Page 237 Section 5 Operating Instructions Preparing to Run Samples Before running specimens, the operator should enter data in the demographics section of the RUN screen to properly identify patient samples. Operator ID The operator should enter an Operator ID before running samples. The Operator ID is displayed on all screens and printed on the graphics report and the blank ticket report.
Page 238 Sample Mixing Proper mixing of specimens prior to sample aspiration is essential for obtaining accurate results on the CELL-DYN 3200 System. For control or calibrator mixing instructions, refer to the manufacturer’s product insert. Specimens stored at refrigerator temperatures must be brought to room temperature prior to mixing.
Page 239 Section 5 Operating Instructions Sample Analysis on the CELL-DYN 3200SL Introduction This section explains how samples are run on the CELL-DYN 3200SL model in both Open and Closed Modes. Samples should not be run until daily QC checks have been performed and the instrument is in the READY state. For convenience, directions for Daily Start Up and QC are given in each section.
Page 240 Operating Instructions Section 5 Sample Analysis on the CELL-DYN 3200SL Sample Loader Operating Tips 1. All Sample Loader tubing must be connected before turning ON the System. 2. All samples must be properly mixed before they are placed in the Sample Loader racks.
Page 241 Section 5 Operating Instructions Closed Mode QC Procedure The operator must manually stop the Sample Loader as directed in this procedure when different levels of controls are run. 1. From the RUN screen, press [SPECIMEN TYPE]. 2. Use the Arrow keys on the keyboard to move the cursor to the appropriate QC file and press [QC SPECIMEN].
Page 242 Operating Instructions Section 5 Sample Analysis on the CELL-DYN 3200SL Open Mode Analysis The Open Sampler mode aspirates the sample from an open collection tube. OPEN SAMPLER is displayed in the upper right corner of the RUN screen when this mode is selected.
Page 243 Section 5 Operating Instructions Closed Mode Analysis The Closed Sampler mode on CELL-DYN 3200SL models aspirates the sample from a closed collection tube that has been placed in a Sample Loader rack and loaded into the Sample Loader. CLOSED SAMPLER is displayed in the upper right corner of the RUN screen when this mode is selected.
Page 244 Operating Instructions Section 5 Sample Analysis on the CELL-DYN 3200SL NOTES 5-92 CELL-DYN ® 3200 System Operator’s Manual 9140181H—October 2001...
Page 245 Section 5 Operating Instructions Sample Analysis on the CELL-DYN 3200CS Introduction This section explains how samples are run on the CELL-DYN 3200CS models, both Open and Closed Modes. Samples should not be run until daily QC checks have been performed and the instrument is in the READY state. For convenience, directions for Daily Start Up and QC are given in each section.
Page 246 Operating Instructions Section 5 Sample Analysis on the CELL-DYN 3200CS QC (Open or Closed Mode) Procedure 1. In the RUN screen, press [SPECIMEN TYPE] 2. Move the cursor to the desired QC file and press [QC SPECIMEN] 3. If necessary, press [CHANGE SAMPLER] to select the desired mode. 4.
Page 247 Section 5 Operating Instructions 5. Press the Touch Plate located behind the probe to start the cycle. The yellow BUSY light on the Analyzer Status Indicator Panel is illuminated. The Status Box on the RUN screen displays messages to indicate the various stages of the cycle.
Page 248 Operating Instructions Section 5 Sample Analysis on the CELL-DYN 3200CS Closed Mode Procedure 1. Be sure that the green READY light on the Analyzer Status Indicator Panel is illuminated and READY is displayed in the Status Box on the RUN screen. 2.
Page 249 Section 5 Operating Instructions Alerts and Indicators This subsection describes information displayed on the screen as the samples are analyzed and/or when reports are printed. This subsection does not discuss how to interpret parameter flags, which are displayed after the sample is run. Refer to Section 3: Principles of Operation;...
Page 250 Operating Instructions Section 5 Alerts and Indicators 3 Consecutive Flow Errors If the Sample Loader is being used and the instrument detects one of the following: 1. Three consecutive RBC flow errors. 2. Three consecutive WOC flow errors. 3. Three consecutive NOC flow errors. The Sample Loader halts at the end of the cycle and the Bulletin line displays the appropriate message: 1.
Page 251 Section 5 Operating Instructions Daily Shutdown Procedure Daily Shutdown The Daily Shutdown Procedure consists of rinsing the Flow System. Whether or not this procedure is followed on a daily basis depends on instrument usage and the laboratory’s procedures. It may not be necessary to perform this procedure every day, since the instrument automatically goes into a STANDBY state (Automatic Shutdown) if it has been idle for four hours.
Page 252 Operating Instructions Section 5 Daily Shutdown Procedure Peristaltic Pump Tubing IMPORTANT: By removing the tubing under the Sample Transfer Peristaltic Pump, the life of the tubing is significantly prolonged. The tubing should be removed if the instrument will be idle for more than 24 hours and reinserted prior to operating the instrument.
Page 253 Section 5 Operating Instructions Prolonged Shutdown If the shutdown time is expected to exceed two weeks, follow the procedure below: 1. In the MAIN MENU, press [SPECIAL PROTOCOLS] 2. Press [AUTO CLEAN] to clean the instrument. 3. Press [PREPARE FOR SHIPPING]. Follow the instructions on the screen. 4.
Page 254 Operating Instructions Section 5 Daily Shutdown Procedure NOTES 5-102 CELL-DYN ® 3200 System Operator’s Manual 9140181H—October 2001...
Page 255 It is essentially a list of samples (including the pre-assigned information) that the operator intends to run on the instrument. Work List entries may be downloaded from a host computer to the CELL-DYN 3200 System, or the entries can be made by an operator at the instrument.
Page 256 Operating Instructions Section 5 Using The Work List Quick Guide The Work List has been designed with three objectives in mind: 1. Relieve the operator from the task of entering demographic data by downloading that data from a host. 2. Process samples quickly, efficiently, and accurately. 3.
Page 257 Section 5 Operating Instructions Work List Review General 1. The Work List is always ON. 2. A host can download Work List records at any time. The instrument will accept any record with data in the <Specimen ID> field. This field may contain a bar code number or other Specimen ID.
Page 258 Operating Instructions Section 5 Using The Work List Format 1. The Work List will be searched only when the following Specimen Types are selected in the RUN screen: Patient, Fragile WBC, or Resistant RBC. Work List cannot be used when Background or QC Specimen are selected. 2.
Page 259 Section 5 Operating Instructions CS Model — Closed Mode In the CS Closed Mode, the Work List is searched after each tube bar code is read (the RUN cycle has begun). Work List entries are matched using one of the following three methods: 1.
Page 260 Operating Instructions Section 5 Using The Work List Figure 5.41 Work List Screen - Page 1 Figure 5.42 Work List Screen - Page 2 5-108 CELL-DYN ® 3200 System Operator’s Manual 9140181H—October 2001...
Page 261 Section 5 Operating Instructions Work List Screen The two pages of the WORK LIST screen are depicted in Figures 5.41 and 5.42. Use the left and right arrow keys to scroll between the pages. 1. Sequence # The sequential number of the Work List entries is displayed in this field. The Work List holds 600 entries.
Page 262 Operating Instructions Section 5 Using The Work List 8. COLLECTION DATE AND TIME The date and time the specimen was collected may be entered in this field. Date is entered as mm/dd for month and day only with no year. Time is entered as hh/mm where hh represents the hour (from 00 to 23) and mm represents the minute (from 00 to 59).
Page 263 Section 5 Operating Instructions Delete All The [DELETE ALL] key is used to delete all data from the Work List. When the [DELETE ALL] key is pressed, the following soft key labels are displayed: CONFIRM DELETION CANCEL DELETION These keys are used to [CONFIRM] or [CANCEL] the Delete All command. Work List Set Up Refer to Work List Set Up Procedure below for a discussion of the WORK LIST SET UP screen and options.
Page 264 Operating Instructions Section 5 Using The Work List Use the arrow keys to move the cursor to the desired field. Use the [TOGGLE ON/ OFF] key to change an option and advance the cursor to the next field. ON/OFF Fields Turning fields ON or OFF in this screen affects the movement of the cursor in the WORK LIST screen when the operator makes entries to the Work List.
Page 265 Section 5 Operating Instructions Work List Set Up Menu Fields 1. SPECIMEN NAME ENTRY SELECTED This field is used to specify whether or not a specimen (patient) name will be entered into the Work List. If this option is turned OFF, the cursor will skip to the next ON field.
Page 266 Operating Instructions Section 5 Using The Work List 8. DEFAULT PATIENT LIMIT SET (1 to 6) This field is used to specify the default (pre-assigned) Patient Limit Set that is automatically assigned to each sample unless otherwise indicated in the Work List.
Page 267 Section 5 Operating Instructions Sample Analysis — SL Model The procedures described below discuss the operation of the Work List in both Open and Closed Modes using either Bar Codes or other Specimen ID for sample identification. Closed Mode On the SL model, although the RUN screen is displayed in the Closed Mode it is not possible to enter data on this screen.
Page 268 Operating Instructions Section 5 Using The Work List 7. Press [START LOADER] to begin sample processing. 8. The samples are processed in the order in which they were placed in the racks. The Sample Loader automatically stops when all samples in the last rack have been processed.
Page 269 Section 5 Operating Instructions NOTE: If the instrument is unable to read a Bar Code on the tube and is unable to read the Bar Code on the rack, a malfunction has occurred. Sample Loader processing is halted. Determine which rack position is the source of the problem before removing the rack.
Page 270 Operating Instructions Section 5 Using The Work List 6. Press [START LOADER] to begin sample processing. 7. The samples are automatically processed in the order in which they were placed in the racks. The Sample Loader automatically stops when all samples in the last rack have been processed.
Page 271 Section 5 Operating Instructions 4. Place the well-mixed sample under the Open Sample Aspiration Probe, make sure the end of the probe is deeply immersed in the sample, and press the Touch Plate to start the cycle. NOTE: Additional entries may be made to the Work List while processing takes place.
Page 272 Operating Instructions Section 5 Using The Work List 5. When all samples have been processed, check to see if all entries have been deleted from the Work List. Entries are automatically deleted from the Work List when a match occurs. Entries remaining in the Work List indicate a successful match did not occur.
Page 273 Section 5 Operating Instructions Running Samples with Bar Codes 1. If Work List records containing bar codes were downloaded from a host, perform steps a through h below. If entries are to be made by the operator at the instrument, go to step 2. a.
Page 274 Operating Instructions Section 5 Using The Work List Using the Work List with Specimen IDs To match Work List entries using Specimen ID, the operator must first enter a sample’s Specimen ID into the <Next ID> field on the RUN screen before running the sample.
Page 275 Section 5 Operating Instructions Open Mode Work List Samples Work List samples are processed in the Open Mode on the CS model in the same manner as on the SL model. For a description of this procedure, refer to Sample Analysis —...
Page 276 Operating Instructions Section 5 Using The Work List NOTES 5-124 CELL-DYN ® 3200 System Operator’s Manual 9140181H—October 2001...
Page 277 Introduction The Data Log stores all data and demographic information in a log format for the last 10,000 cycles run on the CELL-DYN 3200. The record information is stored chronologically by sequence number. Scattergrams and histograms are stored for all 10,000 records.
Page 278 Operating Instructions Section 5 Using The Data Log Figure 5.44 Data Log Screen - Page 1 When the [DATA LOG] key is pressed in the MAIN MENU, the DATA LOG menu and the following soft key labels are displayed: EDIT ID* DISPLAY SPECIMEN FIND SPECIMEN REJECT FROM X-B**...
Page 279 Section 5 Operating Instructions Edit ID The [EDIT ID] key is used to edit the Specimen ID from the DATA LOG screen. When the [EDIT ID] key is pressed, the cursor moves into the <Specimen ID> field and all key labels are blank. Edits are saved by pressing the Enter key on the keyboard. NOTE: The [EDIT ID] key is available only when the cursor is positioned next to a Patient Record.
Page 280 Operating Instructions Section 5 Using The Data Log Previous Specimen The [PREVIOUS SPECIMEN] key is used to display the results for the sequence number preceding the one currently displayed without returning to the main DATA LOG screen. Next Specimen The [NEXT SPECIMEN] key is used to display the results for the sequence number following the one currently displayed without returning to the main DATA LOG screen.
Page 281 Section 5 Operating Instructions Figure 5.46 Data Log Search Screen Find Specimen The [FIND SPECIMEN] key is used to locate a particular record by entering the Sequence number, Specimen ID number or Patient Name for the desired record. When this key is pressed, the DATA LOG SEARCH screen is displayed. (See Figure 5.46.) If the record is not found in the Data Log, the Bulletin line displays the message: NO ENTRY FOUND.
Page 282 Operating Instructions Section 5 Using The Data Log Reject From X-B If the cursor is positioned at a sample identified with a “r”, “w”, or “b” preceding the sequence number (indicating that the results are included in the XB analysis), the [REJECT FROM X-B] key label is displayed.
Page 283 Section 5 Operating Instructions Figure 5.48 Data Log Screen Showing Accept Into X-B Key 5-131 CELL-DYN ® 3200 System Operator’s Manual 9140181H—October 2001...
Page 284 Operating Instructions Section 5 Using The Data Log Customize Data Log The [CUSTOMIZE DATA LOG] key is used to customize the Data Log display. The CUSTOMIZE DISPLAY FOR DATA LOG screen (see Figure 5.49) and the following soft key labels are displayed when the [CUSTOMIZE DATA LOG] key is pressed: SELECT PARAMETER/ PLACE PARAMETER (The key alternates between the selections.)
Page 285 Section 5 Operating Instructions Figure 5.50 Customize Display for Data Log Screen Showing Group 1 Customized Select Parameter The [SELECT PARAMETER] key is used to select a parameter designated by the cursor. When the key is pressed, the selected parameter is highlighted, the label changes to [PLACE PARAMETER], and a [CANCEL SELECTION] key is displayed.
Page 286 Operating Instructions Section 5 Using The Data Log Standard Groups Pre-determined groups of parameters, called Standard Groups, may be selected by pressing the [STANDARD GROUPS] key. Refer to Figure 5.49 which shows the CUSTOMIZE DISPLAY FOR DATA LOG screen with the standard groups displayed. The following soft key labels are displayed when the [STANDARD GROUPS] key is pressed: WBC GROUP...
Page 287 Section 5 Operating Instructions Customize Printout The [CUSTOMIZE PRINTOUT] key is used to customize the printout format of the Data Log. (See Figure 5.51.) The following soft key labels are displayed when the [CUSTOMIZE PRINTOUT] key is pressed: SELECT PARAMETER/ PLACE PARAMETER (The key alternates between the selections.) STANDARD SELECTION...
Page 288 Operating Instructions Section 5 Using The Data Log Transmit Data The [TRANSMIT DATA] key is used to transmit a record to a Laboratory Information System or on-line computer. When the [TRANSMIT DATA] key is pressed, the screen prompts the operator to enter the starting and ending sequence numbers (from the lowest to the highest) for the desired transmission.
Page 289 Section 5 Operating Instructions Figure 5.52 Print Data Log Screen Data Log Codes The Data Log Codes are displayed in the Data Log in the column immediately preceding the date (see Figure 5.52). These codes are displayed in the following order: O —...
Page 290 Operating Instructions Section 5 Using The Data Log An example of codes displayed in the Data Log is shown in Figure 5.53. Figure 5.53 Data Log Codes Screen Data Log Set Up Procedures The Data Log may be configured to display and print results in the order selected by the operator.
Page 291 Section 5 Operating Instructions Figure 5.54 Customize Display for Data Log Screen Showing Standard Groups The display may be customized by selecting the individual parameters, Standard Groups of parameters or a combination of the two. In addition to the usual Hematologic parameters, the following parameters may also be displayed in the Data Log: Nuclear Optical Count...
Page 292 Operating Instructions Section 5 Using The Data Log 6. Repeat steps 3–5 until all selections have been made. 7. If desired, press the Print Screen key on the keyboard to obtain a printout of the selected groups. 8. Press [RETURN] to return to the DATA LOG screen. 9.
Page 293 Section 5 Operating Instructions Figure 5.55 Customize Printout for Data Log Screen Showing Customized Print Group Customizing the Printout The CUSTOMIZE PRINTOUT FOR DATA LOG screen (see Figure 5.55) shows the group of parameters that will be printed on a Data Log printout. A list of the available parameters is displayed under the group.
Page 294 Operating Instructions Section 5 Using The Data Log To Customize the Data Log Printout 1. From the main DATA LOG screen, press [CUSTOMIZE DATA LOG] followed by [CUSTOMIZE PRINTOUT]. 2. Use the Arrow keys on the keyboard to move the cursor to the desired parameter in the list displayed under the printout group.
Page 295 A copy of the RUN screen may be displayed for all 10,000 records in the CELL-DYN 3200 Data Log. A record is displayed by positioning the cursor at the record in the Data Log listing and pressing [DISPLAY SPECIMEN]. The record is displayed on the DISPLAY SPECIMEN screen.
Page 296 Operating Instructions Section 5 Using The Data Log To Find a Record Figure 5.57 Find Specimen Screen 1. From the MAIN MENU screen, press [DATA LOG]. 2. If the desired record is not displayed on the screen, press [FIND SPECIMEN] to display the DATA LOG SEARCH screen.
Page 297 Section 5 Operating Instructions To Edit a Record The Patient Demographics and the Parameter and Patient Limits Sets may be edited for each record. (See Figure 5.58.) Figure 5.58 Edit Specimen Screen To Edit a Specimen 1. From the MAIN MENU screen, press [DATA LOG]. 2.
Page 298 Operating Instructions Section 5 References References 1. NCCLS Standard H3-A3, Procedure for the Collection of Diagnostic Blood Specimens by Venipuncture—Third Edition; Approved Standard (1991). 2. NCCLS Standard H4-A3, Procedure for the Collection of Diagnostic Blood Specimens by Skin Puncture—Third Edition; Approved Standard (1991). 3.
Page 299 Section 6 Calibration Procedures Overview The CELL-DYN 3200 System is calibrated at the factory just prior to shipment. An Abbott Field Service Representative will assist the operator in confirming the calibration during instrument installation. Calibration may be performed using commercial calibrator or fresh whole blood samples. Only the directly measured parameters —...
Page 300 Calibration Procedures Section 6 Overview NOTES CELL-DYN ® 3200 System Operator’s Manual 9140181H—October 2001...
Page 301 NOTE: The procedure for calibrating Closed Mode differs slightly between the SL and CS models. Three methods of calibration are available on the CELL-DYN 3200 System: Auto-Calibration, Enter Factor, and Latex. 1. The Auto-Calibration method is designed to quickly and easily calibrate the system, using commercial control material or fresh whole blood.
Page 302 Section 6 General Information When to Calibrate Scheduled calibration of the CELL-DYN 3200 should conform to the guidelines established by regulatory agencies. Calibration should be confirmed on a regular basis according to the requirements governing quality control in your laboratory. In keeping with good laboratory practices, this should include daily confirmation on each shift and following a reagent lot number change.
Page 303 OSHA Bloodborne Pathogen Rule (29 CFR Part 1910.1030) or other equivalent biosafety procedures. Three types of calibration materials can be used to calibrate the CELL-DYN 3200: • CELL-DYN 22 Calibrator (List Number: 99120-01) or ™...
Page 304 Calibration Procedures Section 6 General Information NOTES CELL-DYN ® 3200 System Operator’s Manual 9140181H—October 2001...
Page 305 If problems are detected during these checks, DO NOT ATTEMPT TO CALIBRATE THE INSTRUMENT. If necessary, CALL THE ABBOTT HEMATOLOGY CUSTOMER SUPPORT CENTER FOR ASSISTANCE. After the problems have been resolved, repeat the Pre-Calibration Procedures to verify proper performance.
Page 306 Calibration Procedures Section 6 Pre-Calibration Procedures 10. Confirm that the waste container is no more than half full. If necessary, empty it as described in Section 8: Hazards; Subsection: Handling and Disposing of Biohazardous Materials. 11. Confirm that background counts are within limits. If the system has been idle for fifteen minutes or more, a Background count should be run immediately prior to running any calibration specimens.
Page 307 These samples must be less than eight hours old by the time calibration is completed. • No more than two hours should elapse between the CELL-DYN 3200 run and the assay by reference methodology or reference instrument. If samples are run on the CELL-DYN 3200 first, assay by reference methodology should be completed within one hour.
Page 308 If the CV for all parameters fall within the limits, go to step 8 to verify Closed Mode precision. If a parameter’s CV exceeds the limit, run the sample again. If the over-limit condition persists, call the Abbott Hematology Customer Support Center for assistance. 6-10 CELL-DYN ®...
Page 309 Section 6 Calibration Procedures 8.______ Verify the Closed Mode precision as follows: a. For the CS model: Use the same sample as in the Open Mode. Select an empty QC file in the SPECIMEN TYPE menu. Make sure Closed Mode is selected.
Page 310 Calibration Procedures Section 6 Pre-Calibration Procedures Problems Detected ________________________________________________________________________________________ ________________________________________________________________________________________ ________________________________________________________________________________________ ________________________________________________________________________________________ ________________________________________________________________________________________ ________________________________________________________________________________________ ________________________________________________________________________________________ ________________________________________________________________________________________ ________________________________________________________________________________________ ________________________________________________________________________________________ ________________________________________________________________________________________ ________________________________________________________________________________________ ________________________________________________________________________________________ ________________________________________________________________________________________ ________________________________________________________________________________________ ________________________________________________________________________________________ ________________________________________________________________________________________ ________________________________________________________________________________________ ________________________________________________________________________________________ ________________________________________________________________________________________ ________________________________________________________________________________________ ________________________________________________________________________________________ ________________________________________________________________________________________ ________________________________________________________________________________________ ________________________________________________________________________________________ ________________________________________________________________________________________ ________________________________________________________________________________________ ________________________________________________________________________________________ ________________________________________________________________________________________ 6-12 CELL-DYN ® 3200 System Operator’s Manual 9140181H—October 2001...
Page 311 Section 6 Calibration Procedures Calibration Menu Overview The CALIBRATION menu is accessed from the MAIN MENU by pressing the [CALIBRATION] key. The CALIBRATION menu displays the current calibration factors for the mode indicated, the date and time the factors were entered, and the operator ID.
Page 312 Calibration Procedures Section 6 Calibration Menu Figure 6.2 Calibration Menu Screen Displaying Closed Sampler Calibration Factors 6-14 CELL-DYN ® 3200 System Operator’s Manual 9140181H—October 2001...
Page 313 Section 6 Calibration Procedures Calibration Menu Soft Keys Enter Factor The [ENTER FACTOR] key is used to display the ENTER CALIBRATION FACTOR screen which displays the current whole blood factors for the displayed mode (refer to Figure 6.3). The soft keys available in this screen are: RESTORE FACTORS RESET ALL TO 1.000 RETURN...
Page 314 Calibration Procedures Section 6 Calibration Menu Calibration Log The [CALIBRATION LOG] key is used to display the CALIBRATION LOG screen for the Open or Closed Mode (refer to Figure 6.4). The soft keys available in this screen are: OPEN SAMPLER/CLOSED SAMPLER PRINT LOG RETURN The CALIBRATION LOG holds 10 entries.
Page 315 Section 6 Calibration Procedures Figure 6.4 Calibration Log Screen (CS Model) Return The [RETURN] key is used to return to the main CALIBRATION menu. Auto-Calibrate The [AUTO-CALIBRATE] key is used to display the AUTO CALIBRATION screen (refer to Figure 6.5). The AUTO CALIBRATION screen changes during the calibration process as reference values are entered and as runs are completed.
Page 316 Calibration Procedures Section 6 Calibration Menu Figure 6.5 Auto Calibration Screen The [WHOLE BLOOD] and [CALIBRATOR] keys alternate to display which type of calibration material is being used. This information is displayed in the upper left corner of the screen and stored with the updated calibration factors on the Calibration Log.
Page 317 The same reference values and the same samples should be used when calibrating both modes. Either mode may be calibrated first, but it is recommended to calibrate the primary mode first. NOTE: Calibrator is the preferred material for calibrating the CELL-DYN 3200 System. When samples are run, Auto-Cal does the following: 1.
Page 318 RUN 9 = 6.5 • RUN 10 = 6.6 The cumulative mean of 6.53 equals the sum of the values (65.3) divided by the 10 runs. 4. Save these values; they will be used to calibrate the CELL-DYN 3200 System. 6-20 CELL-DYN ®...
Page 319 Section 6 Calibration Procedures Auto-Cal Menu When the [AUTO-CALIBRATE] key is pressed in the main CALIBRATION menu, the AUTO-CALIBRATION menu is displayed (refer to Figure 6.6). Reference values are entered on this screen. The Spec ID field in the upper left corner of the screen defaults to “CAL#01” to identify the sample as a “Calibration sample.”...
Page 320 Calibration Procedures Section 6 Auto-Cal Method Figure 6.7 START AUTO CAL Key Displayed A message is displayed on the bulletin line alerting the operator to start running samples. As samples are processed, the results of each run are displayed as shown in Figure 6.8.
Page 321 Section 6 Calibration Procedures Figure 6.8 Results Display Screen As the first sample is processed, the [START AUTO-CAL] key disappears and the [DELETE A RUN] key appears. The [ACCEPT] key appears after the results of the fifth run are displayed. The following information is displayed in the lower portion of the screen: •...
Page 322 Calibration Procedures Section 6 Auto-Cal Method For example: a. Five samples have been run and the [ACCEPT] is displayed after the 5th b. The Factor % Diff for WOC is green, indicating it needs to be calibrated c. The WOC result for Run #4 is highlighted, indicating it failed a reference or precision check d.
Page 323 Section 6 Calibration Procedures Figure 6.9 ACCEPT Key Displayed Figure 6.10 Confirm Acceptance of New Factors 6-25 CELL-DYN ® 3200 System Operator’s Manual 9140181H—October 2001...
Page 324 Calibration Procedures Section 6 Auto-Cal Method Auto-Cal Procedure Open Mode ¥ Displaying the Auto-Cal Screen 1. If necessary, go to the RUN screen and press [CHANGE SAMPLER] to select the Open Mode. 2. In the MAIN MENU, press [CALIBRATION] to display the main CALIBRATION menu. 3.
Page 325 Section 6 Calibration Procedures Calibration Check During the RUN cycle, if a parameter fails the internal reference/precision checks for calibration, the value for that parameter is backlit in green on the run line, dashes are displayed in the Current Factor field, and the Mean Factor is not updated.
Page 326 If no component was changed and your calculations are correct, DO NOT CALIBRATE. CONFIRM THAT ALL PRE-CALIBRATION PROCEDURES WERE COMPLETED AND THEN CALL THE ABBOTT HEMOTOLOGY CUSTOMER SUPPORT CENTER FOR ASSISTANCE (at 1-800-CELL-DYN in the U.S.). For Customers outside the U.S. contact your local Hematology Customer Support Representative.
Page 327 7. If a parameter mean is outside the tolerance limits, perform steps 4 and 5 again. If the mean is still outside the tolerance limits, call the Abbott Hematology Customer Support Center for assistance (at 1-800-CELL-DYN in the U.S.).
Page 328 Calibration Procedures Section 6 Auto-Cal Method Entering Reference Values 1. To enter reference values for each parameter to be calibrated: a. If calibrator is used, if necessary, press [CALIBRATOR], then enter the corresponding reference (assay) value from the sheet enclosed with the calibrator material.
Page 329 Section 6 Calibration Procedures b. If the value is highlighted in green, that parameter needs to be calibrated and the new calibration factor displayed on the screen will replace the existing calibration factor when the [ACCEPT] key is pressed. Green indicates the Factor % Diff is within the range specified in column 3 of Worksheet 6, Closed Mode Calibration Range Criteria, provided in Manual Calibration Worksheets at the end of this section.
Page 330 Go to step 9 below. 8. If a parameter mean is outside the tolerance limits, perform steps 4 and 5 again. If the mean is still outside the tolerance limits, call the Abbott Hematology Customer Support Center for assistance (at 1-800-CELL-DYN in the U.S.).
Page 331 Overview The Enter Factor Calibration Method is used to enter a predetermined factor to adjust calibration when a consistent bias exists between the CELL-DYN 3200 System and a comparison analyzer. This method can also be used when calibrating the secondary mode of the system to the primary mode.
Page 332 2. Mean values should be calculated for each parameter based on 10 runs (five samples, each run twice into one QC file). These mean parameter values can then be entered as reference values on the CELL-DYN 3200 System. ICSH Recommendations When using fresh whole blood samples, reference values should be determined according to the following ICSH recommendations.
Page 333 Reference values for hemoglobin may be determined using either the reference cyanmethemoglobin method or a reliably calibrated hemoglobinometer or hematology analyzer. NOTE: DO NOT attempt to calibrate the CELL-DYN 3200 System with a hemoglobin standard designed for the calibration of specific reference cyanmethemoglobin methods. The instrument uses a modified hemoglobinhydroxyalamine method which is not designed to analyze these standards directly.
Page 334 Calibration Procedures Section 6 Enter Factor Method 2. If a mean value for each parameter based on at least 10 runs is not automatically calculated by the reference hematology instrument or hematology methods, use a calculator to determine the cumulative Reference Mean for each parameter.
Page 335 (NOC) Cumulative Mean NOTE: The WBC value obtained on the Reference Instrument should be used for calibrating both the WOC and NOC parameters on the CELL-DYN 3200 Instrument. Calibration Procedure — Open Mode Follow the procedure below for calibrating the instrument in the Open Mode.
Page 336 Calibration Procedures Section 6 Enter Factor Method 3. Obtain a printout of the current Open Sampler Calibration Factors as follows: a. If necessary, press [OPEN SAMPLER] to display the Open Sampler Calibration Factors. b. Press [PRINT] to obtain a printout of these factors. Save this printout. It will be used when completing Worksheet 1 at the end of this section.
Page 337 Section 6 Calibration Procedures 9. To determine the New Calibration Factor for each parameter: a. For Calibrator, use the values on the assay sheet and the CELL-DYN mean values determined in steps 2 through 8 above. Enter this information in columns 1 and 2 respectively of Worksheet 1, Open Mode Calibration —...
Page 338 If no component was changed and your calculations are correct, DO NOT CALIBRATE. Confirm that all Pre-Calibration procedures were completed and call the Abbott Hematology Customer Support Center for assistance (at 1-800-CELL-DYN in the U.S.). 7. Based on the results from steps 1 through 6 above, do one of the following: a.
Page 339 Section 6 Calibration Procedures Entering New Calibration Factors — Open Mode 1. In the main CALIBRATION menu, press [ENTER FACTOR]. 2. Use the arrow keys to select the first factor in the Open Sampler column to be changed. Type in the New Calibration Factor calculated in step 10 in Determining New Calibration Factors above.
Page 340 6. If a parameter’s mean is outside the stated tolerance limits, repeat steps 3 and 4 above for that parameter. If the mean is still outside the stated tolerance limits, call the Abbott Hematology Customer Support Center for assistance (at 1-800-CELL-DYN in the U.S.).
Page 341 Section 6 Calibration Procedures Calibration Procedure — Mode to Mode Follow the procedure below for calibrating the instrument in the Closed Mode. NOTE: Use the same Calibrator or Fresh Whole Blood samples for calibrating Open and Closed Modes. Determining the Closed Mode Mean 1.
Page 342 Calibration Procedures Section 6 Enter Factor Method 6. Calibrating the SL model with Calibrator or Fresh Whole Blood: a. Determine the number of runs you expect to make (6 runs should be the minimum for calibrator, 10 runs for fresh whole blood) and obtain the same number of empty 5-mL tubes containing no anticoagulant.
Page 343 CALIBRATION IS REQUIRED for that parameter. d. If no component was changed and your calculations are correct, DO NOT CALIBRATE. Confirm that all Pre-Calibration procedures were completed and call the Abbott Hematology Customer Support Center for assistance (at 1-800-CELL-DYN in the U.S.). 6-45 CELL-DYN ®...
Page 344 'R QRW FDOLEUDWH WKDW SDUDPHWHU Recheck all calculations. If the factor(s) is still outside the acceptable range, call the Abbott Hematology Customer Support Center for assistance (at 1-800-CELL-DYN in the U.S.).
Page 345 Section 6 Calibration Procedures Entering New Calibration Factors — Closed Mode 1. In the CALIBRATION menu, press [ENTER FACTOR]. 2. Use the arrow keys to select the first factor in the Closed Sampler column to be changed. Type in the New Calibration Factor calculated in Calculating New Closed Mode Calibration Factors above.
Page 346 6. If a parameter’s mean is outside the stated tolerance limits, repeat steps 3 and 4 above for that parameter. If the mean is still outside the stated tolerance limits, call the Abbott Hematology Customer Support center for assistance (at 1-800-CELL-DYN in the U.S.).
Page 347 Calibration Backup The current calibration factors should be saved on the CELL-DYN 3200 Set-Up Disk #1whenever calibration is changed. Data should also be saved whenever any Set-Up information is changed and after any service work is performed. The back-...
Page 348 This option is used when a hardware or software failure occurs and should only be used at the direction of the Abbott Hematology Customer Support Center. NOTE: In the message “Write Protect Error Writing Drive A” displays, eject the SET-UP Disk.
Page 349 Manual Calibration Worksheets Seven worksheets are provided to assist in the calculation and determination of new calibration factors for the CELL-DYN 3200 System. Three worksheets are designed for the Open Mode procedure, three worksheets for the Closed Mode procedure, and one worksheet for confirmation.
Page 350 Calibration Procedures Section 6 Manual Calibration Worksheets Worksheet 1 Open Mode Calibration — New Factors Instrument: Date: Operator: (Calculate All Factors To Three Decimal Places) Assay Value Current Open Mode Open Mode Open Mode Range Mean Ref Mean Cal Factor Cal Factor 0.700–1.300 0.700–1.300...
Page 351 1. In column 1, enter the new Factor % Diff from column 5 of the previous worksheet (disregard the sign). 2. If the new Factor % Diff exceeds the limit in column 4, DO NOT CALIBRATE. Call the Abbott Hematology Customer Support Center for assistance.
Page 352 1. In column 1, enter the % Diff from column 5 of Worksheet 4 (disregard the sign). 2. If the % Diff exceeds the limit in column 4, DO NOT CALIBRATE. Call the Abbott Hematology Customer Support Center for assistance.
Page 353 Current factor as printed by the operator in the Preparing for Manual Mode to Mode Calibration section within this procedure (Manual Mode to Mode Calibration). ** If factor exceeds limits, do not calibrate. Check all calculations and call the Abbott Hematology Customer Support Center for assistance (at 1-800-CELL-DYN in the U.S.).
Page 354 Calibration Procedures Section 6 Manual Calibration Worksheets Worksheet 7 Calibration Confirmation QC Specimen Type Sample # Mean Value of 3/5 Runs Reference or Assay Value Difference (absolute value) Tolerance Limits * 1. Select QC as the specimen type and run the calibrator or fresh whole blood sample 5 times. 2.
Page 355 Section 6 Calibration Procedures References 1. ICSH, Protocol for Evaluation of Automated Blood Cell Counters, Clinical and Laboratory Hematology 1988, 10:203, 212. 2. NCCLS standard H7-A, Procedure for Determining Packed Cell Volume by the Microhematocrit Method; Approved Standard (1985). 6-57 CELL-DYN 3200 System Operator’s Manual ®...
Page 356 Calibration Procedures Section 6 References NOTES 6-58 CELL-DYN ® 3200 System Operator’s Manual 9140181H—October 2001...
Page 357 • The location should have nonporous, nonabsorbing work surfaces and flooring that can be cleaned easily and disinfected using recommended procedures. • Place the CELL-DYN 3200 System on a hard, level surface. Locate the system: – away from direct sunlight.
Page 358 Operational Precautions and Limitations Section 7 Overview • Do not place reagent containers above the Analyzer. • The following space should be available to ensure proper ventilation: – Bench top space: approximately 6 linear feet to accommodate the instrument, display station, and printer –...
Page 359 • Never add remaining reagent from a container being replaced to a freshly opened container. This may contaminate the new reagent. • Never use a hemoglobin standard other than the one specified for the CELL-DYN 3200 System. The CELL-DYN 3200 System uses a cyanide-free reagent. Printer Precautions The printhead on dot matrix printers can get very hot during extended periods of printing.
Page 360 Operational Precautions and Limitations Section 7 Precautions NOTES CELL-DYN ® 3200 System Operator’s Manual 9140181H—October 2001...
Page 361 Abbott Representative. This section provides precautionary warnings and information necessary for the safe use of the CELL-DYN 3200 System. Supplementary warnings are inserted throughout this manual and on the instrument to alert personnel to potential hazards. Whenever hazard symbols are encountered on the instrument, users must consult the Operator’s Manual to determine the nature of the potential hazard and...
Page 362 Hazards Section 8 Overview NOTES CELL-DYN 3200 System Operator’s Manual ® 9140181K—July 2002...
Page 363 Section 8 Hazards Hazard Information and Precautions General Automated hematology instruments require the handling of whole blood and blood components by laboratory personnel. In addition, personnel must conduct maintenance to ensure proper performance of the instrument. These activities result in potential contact with infectious substances and other hazards. The following are warnings, precautions, and standard practices to help prevent injury.
Page 364 (such as the LIS connector). • Keep the floor dry. • The electrical circuit spacing of the CELL-DYN 3200 System is based on pollution degree (1) and altitude [up to 2000 M (6500 ft)] as per IEC 61010-1.
Page 365 Section 8 Hazards Physical and Mechanical Hazards Observe these basic rules for mechanical safety: • Carefully follow all procedures and instructions. • Keep all protective covers in place when processing specimens. • Never allow any part of your body to enter the region of movement of any mechanical component when the instrument is operating.
Page 366 Hazard Information and Precautions Laser Hazards The CELL-DYN 3200 Instrument is a Class 1 (Class I) Laser Product per IEC 60825-1. However, it contains a Class 3 B laser. CAUTION: Class 3 B Laser Light when open. Avoid Exposure to Beam.
Page 367 Section 8 Hazards 1 Protective Cover 2 Laser Warning Label CAUTION … CLASS 3B LASER LIGHT WHEN OPEN. AVOID EXPOSURE TO BEAM. PN 9230701E Figure 8.2 Laser Warning Label Position - Protective Cover 1 Laser Warning Label CAUTION – CLASS 3B LASER LIGHT WHEN OPEN. AVOID EXPOSURE TO BEAM.
Page 368 Hazards Section 8 Hazard Information and Precautions The Class 1 Laser Product Label (Abbott P/N 9230702), shown in Figure 8.4, consists of black lettering against a yellow background. CLASS 1 LASER PRODUCT PN 9230702 Figure 8.4 Class 1 Laser Product Label The label is located on the upper left section of the instrument’s Rear Panel and is...
Page 369 Section 8 Hazards References 1. Occupational Safety and Health Administration, 29 CFR Part 1910.1030. Department of Labor. Occupational Exposure to Bloodborne Pathogens; Final Rule. 235:64175-64182, 1991. 2. IEC 60825-1, International Electrotechnical Commission World Standards for electrical and electronic engineering, 60825: Safety of laser products, 60825-1 Part 1: Equipment classification, requirements, and users guide.
Page 370 Hazards Section 8 References NOTES 8-10 CELL-DYN 3200 System Operator’s Manual ® 9140181K—July 2002...
Page 371 Section 9 Service and Maintenance Overview The CELL-DYN 3200 is designed to require minimal routine maintenance. For example: • The fluidics are automatically rinsed between samples. • The instrument is automatically placed in the Standby state if it has been idle for four hours after the last cycle is completed.
Page 372 Service and Maintenance Section 9 Overview NOTES CELL-DYN ® 3200 System Operator’s Manual 9140181H—October 2001...
Page 373 Section 9 Service and Maintenance Special Protocols The SPECIAL PROTOCOLS menu is used to access various preventative maintenance procedures. There are two major screen levels in this menu. The first level is displayed when the [SPECIAL PROTOCOLS] soft key in the MAIN MENU is pressed.
Page 374 Service and Maintenance Section 9 Special Protocols CLEAN/RES SHEAR VAL/ CLEAN SHEAR VAL/ .H\ ODEHO DOWHUQDWHV EHWZHHQ VHOHFWLRQV RESTORE SHEAR VAL DIS/ ENAB ANALYZER/ DISABLE ANALYZER/ (.H\ ODEHO DOWHUQDWHV EHWZHHQ VHOHFWLRQV ENABLE ANALYZER MORE MAIN A brief description of the function of each soft key follows. Instructions for the detailed use of each key are given in the appropriate maintenance procedure.
Page 375 Section 9 Service and Maintenance The screen displays instructions for draining and filling the reagent reservoirs, as shown in Figure 9.2. Empty Dil/Sheath When the [EMPTY DIL/SHEATH] key is pressed, the diluent and sheath reservoirs are drained and the key toggles to [FILL DIL/ SHEATH]. When the [FILL DIL/SHEATH] key is pressed, the diluent and sheath reservoirs are refilled.
Page 376 Service and Maintenance Section 9 Special Protocols Pressing the [DISABLE ANALYZER] key prevents the Analyzer from cycling while certain maintenance procedures are performed. After the Analyzer has been disabled, the key toggles to [ENABLE ANALYZER]. When the [ENABLE ANALYZER] key is pressed, the Analyzer is returned to the state prior to disabling.
Page 377 Section 9 Service and Maintenance The [AUTO CLEAN] key is used to initiate the Auto-Clean cycle. The Shear Valve, the RBC/PLT Mixing Chamber, the WBC Mixing Chamber, the Optical Flow Cell, the HGB Flow Cell, and all of the associated fluidics are automatically cleaned and rinsed during this cycle.
Page 378 Service and Maintenance Section 9 Special Protocols NOTES CELL-DYN ® 3200 System Operator’s Manual 9140181H—October 2001...
Page 379 Overview The maintenance schedule outlined on the following page will minimize operational problems with the CELL-DYN 3200. The recommended intervals are based on instruments operating in laboratories that process samples from a general patient population. The intervals are affected by the following variables: •...
Page 380 Keep a record of routine maintenance and parts replacement to ensure proper equipment care and to assist Abbott Customer Support Specialists and Abbott Field Service Representatives in diagnosing instrument problems.
Page 381 Section 9 Service and Maintenance Replace Tubing in Normally Closed Valves Replace Syringes Replace Fuse Prepare for Shipping or Extended Period of Non-Use Clean Y Valve Flow Panel Components Figure 9.4 illustrates the Flow Panel components that may be inspected, cleaned, or replaced during normal maintenance procedures.
Page 382 Service and Maintenance Section 9 Preventive Maintenance Schedule Decontamination Procedures The OSHA Bloodborne Pathogen Rule (29 CFR Part 1910.1030) requires the decontamination of laboratory equipment prior to servicing or shipment: • Decontaminate the instrument by performing the Auto-Clean cycle. This cycle flushes all of the fluid pathways with reagents to purge any waste from the fluid pathways.
Page 383 Section 9 Service and Maintenance Daily Maintenance Procedures Auto-Clean WARNING: Potential Biohazard. Wear gloves, lab coats, and safety glasses and follow other biosafety practices as specified in the OSHA Bloodborne Pathogen Rule (29 CFR Part 1910.1030) or other equivalent biosafety procedures. The Auto-Clean Cycle is a fully automated cycle designed to clean the Shear Valve, RBC/PLT Mixing Chamber, the WBC Mixing Chamber, the Optical Flow Cell, the HGB Flow Cell, Open Sample Probe, the needle in the Tower Module,...
Page 384 Service and Maintenance Section 9 Daily Maintenance Procedures Materials Required 1. CELL-DYN Enzymatic Cleaner. Enzymatic cleaner should be used at room temperature but stored at a temperature between 2°C and 8°C (36°F and 46°F). 2. Clean VACUTAINER ® tube or other clean container 3.
Page 385 Section 9 Service and Maintenance Clean Aspiration Needle The Aspiration Needle in the Tower Module should be cleaned regularly to remove protein buildup or debris and reduce the possibility of a blockage. The procedure for cleaning the needle differs slightly on the CS and SL models. Both procedures are described below.
Page 386 Service and Maintenance Section 9 Daily Maintenance Procedures Procedure — CS Model 1. Aliquot approximately 2 mL of Enzymatic Cleaner into one of the VACUTAINER ® tubes. 2. Aliquot approximately 2 mL of diluent each into the other two VACUTAINER ®...
Page 387 Section 9 Service and Maintenance Sample Loader Tray and Tube Grippers Daily cleaning of the Sample Loader tray and tube grippers is recommended when the Sample Loader is used. Materials Required 1. Cleaning solution (0.5% sodium hypochlorite solution). See the formula for mixing this solution under Decontamination Procedures earlier in this section.
Page 388 Service and Maintenance Section 9 Daily Maintenance Procedures NOTES 9-18 CELL-DYN ® 3200 System Operator’s Manual 9140181H—October 2001...
Page 389 Section 9 Service and Maintenance Weekly Maintenance Procedures WARNING: Potential Biohazard. Wear gloves, lab coats, and safety glasses and follow other biosafety practices as specified in the OSHA Bloodborne Pathogen Rule (29 CFR Part 1910.1030) or other equivalent biosafety procedures. Sample Loader and Racks The Sample Loader surface areas and racks should be cleaned on a regular basis.
Page 390 Service and Maintenance Section 9 Weekly Maintenance Procedures 1 Tubing 2 Pump Shoe 3 Pump Wheel Figure 9.6 Sample Transfer Peristaltic Pump To check the peristaltic pump tubing, follow the procedure below: 1. In the MAIN MENU, press [SPECIAL PROTOCOLS] followed by >DIS/ENAB ANALYZER] and [DISABLE ANALYZER] to disable the Analyzer.
Page 391 Section 9 Service and Maintenance Monthly Maintenance Procedures WARNING: Potential Biohazard. Wear gloves, lab coats, and safety glasses and follow other biosafety practices as specified in the OSHA Bloodborne Pathogen Rule (29 CFR Part 1910.1030) or other equivalent biosafety procedures. Fan Filter Cleaning There is an air filter on the rear panel of the Analyzer.
Page 392 Service and Maintenance Section 9 Monthly Maintenance Procedures Materials Required 1. Running water 2. DYN-A-WIPE lint-free pads (or other lint-free pads) 3. Small vacuum cleaner (optional) Filter Cleaning Procedure 1. Perform the Daily Shutdown procedure to place the instrument in STANDBY. (Refer to Daily Shutdown Procedure in Section 5: Operating Instructions.) 2.
Page 393 Section 9 Service and Maintenance Extended Auto-Clean NOTE: Run Extended Auto-Clean weekly when routinely running reticulocytes. The Extended Auto-Clean cycle is a fully automated cycle designed to clean the Shear Valve, the RBC/PLT and WBC Mixing Chambers, the Optical Flow Cell, the HGB Flow Cell, the needle in the CS or SL model, and all the associated fluidics.
Page 394 Service and Maintenance Section 9 Monthly Maintenance Procedures Materials Required 1. CELL-DYN Enzymatic Cleaner (List Number 99644-01) 2. Clean test tube or container 3. DYN-A-WIPE lint-free pads (or other lint-free pads) 4. Warm water Procedure 1. Make sure the Open Sampler mode is selected. 2.
Page 395 Section 9 Service and Maintenance Diluent/Sheath Filter Replacement Procedure The Diluent/Sheath Filter is located on the front panel to the left of waste chamber #3. Replace the filter once a month, or whenever contamination is suspected. A sign of contamination is usually manifested by high platelet background, poorly defined PLT-RBC (0°/10°) scatterplot, excessive WBC flagging, or erroneous 5-part differential results.
Page 396 Service and Maintenance Section 9 Monthly Maintenance Procedures 6. Pinch off the tubing above the luer slip inlet with hemostats. Clamp the tubing above the Diluent/Sheath Filter. NOTE: Be sure not to damage the luer slip inlet port. 7. Disconnect the luer slip inlet from the used Diluent/Sheath Filter. NOTE: Use a paper towel to absorb any liquid discharged from the filter or tubing.
Page 397 Section 9 Service and Maintenance Semiannual Maintenance Procedures Printer Cleaning Every six months (or after about 300 hours of operation) turn the printer OFF, disconnect the power cord and use a clean, dry cloth to dust the area around the carriage shaft and platen or ink cartridge (depending on type of printer).
Page 398 Service and Maintenance Section 9 Semiannual Maintenance Procedures NOTES 9-28 CELL-DYN ® 3200 System Operator’s Manual 9140181H—October 2001...
Page 399 Section 9 Service and Maintenance Nonscheduled Maintenance Frequency Table 9.1 Nonscheduled Maintenance Frequency Procedure Frequency Clean Shear Valve When it is suspected of being the source of imprecision. Clean Interior of Open Sample When it is suspected of being the source Aspiration Probe of imprecision Unclog Open Sample Aspiration...
Page 400 Service and Maintenance Section 9 Nonscheduled Maintenance Frequency Procedure Frequency Replace Closed Sample Aspiration 1. When the needle is bent Needle 2. When there is a nonremovable obstruction in the needle Replace Tubing in Sample Transfer When it shows signs of indentation or Pump flattening Replace Tubing in Normally Closed...
Page 401 The shear valve is made of a ceramic material and consists of three separate sections — front, center and rear. The rear and front sections are connected to the CELL-DYN 3200 by tubing that should not be removed. NOTE: The center section is not connected by tubing and must be handled carefully, as it will break if it is dropped.
Page 402 Service and Maintenance Section 9 Nonscheduled Maintenance Procedures Procedure 1. Pull the Tower Cover up and off the instrument (Tower Door on the CS model must be open). 2. In the MAIN MENU, press [SPECIAL PROTOCOLS] followed by [CLEAN/RES SHEAR VAL@ DQG [CLEAN SHEAR VAL] This prepares the Shear Valve for removal and puts the Analyzer into the NOT READY mode.
Page 403 Section 9 Service and Maintenance 14. Align the lock notch of the center section with the mounting guide. (Lock notch faces the mounting guide, smaller rim notch faces down.) Carefully slide this section back onto the mounting arm until it is flush with the rear section.
Page 404 Service and Maintenance Section 9 Nonscheduled Maintenance Procedures Procedure WARNING: Potential Biohazard. The probe is sharp and potentially contaminated with infectious material. Avoid contact with tip of probe. 1. In the MAIN MENU, press [SPECIAL PROTOCOLS] IROORZHG E\ >DIS/ENAB ANALYZER@ DQG [DISABLE ANALYZER]. 2.
Page 405 Section 9 Service and Maintenance 5. Fill the same syringe with deionized water and inject the water into the probe from the top to rinse the probe. Repeat the procedure three times to thoroughly rinse the probe. NOTE: Empty the container or tube between rinses as necessary. 6.
Page 406 Service and Maintenance Section 9 Nonscheduled Maintenance Procedures Unclogging the Open Sample Aspiration Probe If a blockage is suspected, it may be cleared using the procedure described above in Open Sample Probe Interior Cleaning. Closed Sample Needle Interior Cleaning The Aspiration Needle in the Tower Module should be cleaned regularly to remove protein buildup or debris and reduce the possibility of a blockage.
Page 407 Section 9 Service and Maintenance 6. Carefully pull the top of the needle forward until the flange clears the slot in the bracket. Lift the needle up and out of the Wash Block and place it in the beaker or container. 1 Holding Clip 2 Aspiration Tubing 3 Vent Tubing...
Page 408 Service and Maintenance Section 9 Nonscheduled Maintenance Procedures 10. Place the needle back into the Wash Block, making sure the shorter part (vent needle) faces the instrument, and place the flange into its slot in the top bracket. 11. Reinstall the clip over the top of the needle and tighten the thumb screw. 12.
Page 409 CELL-DYN 3200 system. The syringe assemblies are depicted in Figure 9.13. Syringes on the CELL-DYN 3200 System should be cleaned only as necessary one at a time to ensure that each syringe is replaced in the correct position. Replace each syringe after it is cleaned and then remove the next one to be cleaned.
Page 410 Service and Maintenance Section 9 Nonscheduled Maintenance Procedures Materials Required 1. A large container filled with approximately 500 mL of warm, deionized water 2. DYN-A-WIPE lint-free pads (or other lint-free pads) 3. Distilled water 4. Small container of each reagent to refill the clean syringes 5.
Page 411 Section 9 Service and Maintenance Figure 9.15 Sample Loader Mounting Screws 3. Carefully lift and pull the Sample Loader away from the instrument approximately 2-3 inches. 4. Push the Sample Loader down to lock it in to place. 1 Tube Fitting 2 Sample Injection Syringe 3 Double Collar...
Page 412 Service and Maintenance Section 9 Nonscheduled Maintenance Procedures Procedure Sample Injection Syringe — 1. The syringe snaps into the holding block. To remove the syringe, place on finger behind the upper portion of the barrel and one finger behind the lower portion of the plunger.
Page 413 Section 9 Service and Maintenance Procedure Diluent/Sheath Syringe — 1. Locate the Diluent/Sheath Syringe (refer to Figure 9.17). Note that the plastic barrel of this syringe has four vertical edges, two of which fit into grooves on the holding block, and a circular plastic flange which also fits into a groove on the holding block.
Page 414 Service and Maintenance Section 9 Nonscheduled Maintenance Procedures 1 Tube Fitting 2 Luer Lock 3 Holding Block 4 Diluent/Sheath Syringe 5 Double Collar Figure 9.17 Diluent/Sheath Syringe Replacement 9. Insert the double collar on the plunger into the slot on the mounting bracket and line up the circular flange on the barrel with the slot on the holding block.
Page 415 HGB Flow Cell Manual Cleaning Procedure NOTE: This is not a routine cleaning/maintenance procedure. It should only be performed if routine methods fail or at the request of the Abbott Hematology Customer Support Center. Under normal circumstances, the Auto-Clean cycle is sufficient to ensure the cleanliness of the HGB Flow Cell.
Page 416 Service and Maintenance Section 9 Nonscheduled Maintenance Procedures 1 Solenoid 24 2 Tube Fitting 3 Shear Valve Figure 9.18 HGB Flow Cell Access Tubing Materials Required 1. Cleaning solution (1.25% sodium hypochlorite solution). See the formula for mixing this solution under Decontamination Procedures earlier in this section.
Page 417 Section 9 Service and Maintenance 5. Locate the tubing just above solenoid #24 that attaches to the HGB Flow Cell. (Refer to the previous figure.) Attach a hemostat to the tubing between the fitting and the HGB Flow Cell. 6. Disconnect the tubing from the fitting and insert the syringe. Remove the hemostat.
Page 418 Service and Maintenance Section 9 Nonscheduled Maintenance Procedures Reagent Line Cleaning The reagent lines should be cleaned if contamination is suspected. To clean the lines, refer to steps 1–4 in Preparation for Shipping or Extended Period of Non-Use later in this section. Open Sample Probe Replacement Materials Required 1.
Page 419 Section 9 Service and Maintenance Figure 9.19 Open Sample Probe Replacement 8. Hold the probe steady and reinsert the tubing over the top. Use the pliers to carefully work the tubing down the probe. Be sure the tubing is firmly seated on the probe.
Page 420 Service and Maintenance Section 9 Nonscheduled Maintenance Procedures Closed Sample Needle Replacement If the Closed Sample Aspiration Needle becomes bent or becomes clogged (and cleaning does not remove the blockage), the needle should be replaced. Materials Required 1. Gloves, lab coat, and safety glasses 2.
Page 421 Section 9 Service and Maintenance 1 Holding Clip 2 Aspiration Tubing 3 Vent Tubing 4 Needle Top 5 Vent Needle (shorter) 6 Aspiration Needle (longer) 7 Wash Block 8 Needle Mounting Assembly 9 Thumb Screw (with spring) Figure 9.20 Closed Sample Needle 4.
Page 422 Service and Maintenance Section 9 Nonscheduled Maintenance Procedures 10. Reattach the Tower Cover (Tower Door on the CS model must be open) and press into place. 11. Press [ENABLE ANALYZER] followed by [RETURN] and [MAIN] to return to the MAIN MENU. 12.
Page 423 Section 9 Service and Maintenance Normally Closed Valve Tubing Replacement Tubing in the Normally Closed Valves should be replaced when it shows signs of indentation or flattening and is impeding the flow of fluid through the tubing. Materials Required 1. Valve Tubing (12 inches) 2.
Page 424 Service and Maintenance Section 9 Nonscheduled Maintenance Procedures 1 Connectors 2 Tubing 3 Slot 4 Normally Closed Valve Figure 9.21 Tubing in Normally Closed Valve 9. Insert the new tubing section into both connectors. Make sure the tubing is pushed all the way into the connectors. 10.
Page 425 Section 9 Service and Maintenance Syringe Replacement A syringe should be replaced under the following conditions: 1. There is evidence of leaking 2. It is suspected of being a source of imprecision. Materials Required 1. Replacement syringe 2. Gloves, lab coat, and safety glasses Procedure 1.
Page 426 Service and Maintenance Section 9 Nonscheduled Maintenance Procedures 1 Power Supply 2 Fuse Holder 3 Fuse Holder Notch Figure 9.22 Fuse Replacement 5. If it has obviously failed, replace it. Note the amp reading on the fuse and be sure you replace it with the correct fuse (8-amp or 4-amp). NOTE: If the power setting is 110/120 VAC, use the 8-amp fuse.
Page 427 Section 9 Service and Maintenance Salt deposits and reagent residue may clog the flow system if they are not removed prior to a prolonged period of inactivity or shipment. In addition, the tubing should be removed from behind the Peristaltic Pump and from all of the Normally Closed Valves.
Page 428 Service and Maintenance Section 9 Nonscheduled Maintenance Procedures b. The skirt on the SL model has two removable sections adjacent to the Flow Panel. Remove the section on the left side of the Flow Panel by lifting it up and off its holding pins. 7.
Page 429 Section 9 Service and Maintenance Y Valve Cleaning The Y Valve should be cleaned whenever an obstruction in the valve is suspected. If an obstruction in suspected in the Open Mode, follow the instructions in Procedure - Open Mode below. If the Obstruction is suspected in the Closed Mode, follow the instructions in Procedure - Closed Mode which follows Procedure - Open Mode.
Page 430 Service and Maintenance Section 9 Nonscheduled Maintenance Procedures Figure 9.23 Y Valve Cleaning 9. Disconnect this tubing at the Shear Valve and place the end in the beaker to catch liquid. 10. Slowly inject the cleaning solution into the Y Valve. The liquid should pass through the Y Valve carrying any obstructing particles with it.
Page 431 Section 9 Service and Maintenance 22. If the counts are unacceptable, troubleshoot accordingly (refer to Section 10: Troubleshooting and Diagnostics; Subsection: Troubleshooting Guide). Rerun samples and confirm that problem is resolved. 23. Record the completion of this procedure in the maintenance log. Procedure - Closed Mode Gently pull on hand hold of the Right Front Cover and swing the cover open.
Page 432 Service and Maintenance Section 9 Nonscheduled Maintenance Procedures 19. Run at least three background counts. Check that the background counts are acceptable before running controls or patient samples. 20. If the counts are unacceptable, troubleshoot accordingly (refer to Section 10: Troubleshooting and Diagnostics;...
Page 433 Service and Maintenance Section 9 Nonscheduled Maintenance Procedures 9-63 CELL-DYN ® 3200 System Operator’s Manual 9140181H—October 2001...
Page 434 Service and Maintenance Section 9 Nonscheduled Maintenance Procedures 9-64 CELL-DYN ® 3200 System Operator’s Manual 9140181H—October 2001...
Page 435 This section gives instructions for identifying, troubleshooting and correcting instrument problems. It is intended as a referral guide for customer troubleshooting and optimal instrument operation. The CELL-DYN 3200 continuously monitors the status of the system and displays pertinent information in the Status Box or on the Bulletin Line.
Page 436 Troubleshooting and Diagnostics Section 10 Overview NOTES 10-2 CELL-DYN ® 3200 System Operator’s Manual 9140181H—October 2001...
Page 437 Section 10 Troubleshooting and Diagnostics Diagnostics Menu Overview This subsection describes the soft keys available from the DIAGNOSTICS MENU screens. These keys enable the operator or service representative to obtain information and execute programs that assist in troubleshooting and identify corrective action.
Page 438 Troubleshooting and Diagnostics Section 10 Diagnostics Menu Diagnostics Menu Screen The first DIAGNOSTICS MENU screen (see Figure 10.1) and the following soft key labels are displayed when the [DIAGNOSTICS] key is pressed: FAULT REPORT EXECUTION TIMES CNT RATE SUMMARY CLEAR FAULTS RAW DATA SUMMARY MORE MAIN...
Page 439 Section 10 Troubleshooting and Diagnostics Figure 10.3 Fatal Fault Report Screen Figure 10.4 Fault Report — No Fault Pending Screen 10-5 CELL-DYN ® 3200 System Operator’s Manual 9140181H—October 2001...
Page 440 Troubleshooting and Diagnostics Section 10 Diagnostics Menu Operator correctable faults (for example, waste full, diluent empty) can be cleared by pressing the [CLEAR FAULT] key after taking corrective action. After corrective action for a fatal fault, the system must be reinitialized by pressing the [INITIALIZATION] soft key in the second DIAGNOSTICS MENU screen (refer to Figure 10.9).
Page 441 Section 10 Troubleshooting and Diagnostics Figure 10.6 WOC Count Rate Data Each key displays kinetic data for the selected parameter from the last cycle run. When each key is pressed, the count rate data is displayed (see Figure 10.6) and the key label changes to [CNT GRAPH] for that parameter.
Page 442 Troubleshooting and Diagnostics Section 10 Diagnostics Menu Figure 10.7 WOC Count Rate Graph Clear Faults When the [CLEAR FAULTS] key is pressed, the Analyzer returns to the READY state if the corrective action taken resolved the problem. If the corrective action did not correct the problem, the fault status does not change.
Page 443 Section 10 Troubleshooting and Diagnostics Figure 10.8 Raw Data Summary Screen Raw Data Summary When the [RAW DATA SUMMARY] key is pressed, detailed information pertaining to the last cycle run is displayed. An example of the RAW DATA SUMMARY screen is shown in Figure 10.8.
Page 444 SOLENOID OPERATION PUMP OPERATION DRAIN ACCUMULATOR INITIALIZATION MORE MAIN Motor Operation This key should be used only by an authorized Abbott representative. The system must be initialized after this key is pressed. 10-10 CELL-DYN ® 3200 System Operator’s Manual 9140181H—October 2001...
Page 445 Section 10 Troubleshooting and Diagnostics Solenoid Operation This key should be used only by an authorized Abbott representative. The system must be initialized after this key is pressed. Figure 10.10 Pump Operation Screen Pump Operation When the [PUMP OPERATION] key is pressed, the following soft key labels (see Figure 10.10) are displayed:...
Page 446 Troubleshooting and Diagnostics Section 10 Diagnostics Menu Figure 10.11 Pump Operation Screen — Vacuum ON Vacuum On When the [VACUUM ON] key is pressed, the key label changes to [VACUUM OFF], the vacuum pump is turned ON and the screen displays the message Vacuum Is On. (See Figure 10.11.) Press the [VACUUM OFF] key to turn the pump OFF.
Page 447 Section 10 Troubleshooting and Diagnostics Figure 10.12 Inhibit Pumps Screen Inhibit Pumps When the [VACUUM] or [PRESSURE] key is pressed, the [INHIBIT PUMPS] key appears. (See Figure 10.12.) When the [INHIBIT PUMPS] key is pressed, the operation of the pumps is inhibited (no vacuum and pressure are produced), the screen displays the message Vacuum Is Inhibited, and the key label changes to [ENABLE PUMPS].
Page 448 Troubleshooting and Diagnostics Section 10 Diagnostics Menu Figure 10.13 Vacuum Test Screen Vacuum Test When the [VACUUM TEST] key is pressed, the system releases the vacuum to atmosphere and then determines the amount of time required for it to return to the correct level.
Page 449 Section 10 Troubleshooting and Diagnostics Figure 10.14 Drain Accumulators Screen Drain Accumulator When the [DRAIN ACCUMULATOR] key is pressed, the internal vacuum accumulators are drained of accumulated fluid. This key is used to correct the “Vacuum Accumulator Wet” fault. The screen displays (see Figure 10.14) the following message: After draining the accumulators, press INITIALIZATION key to return to normal operation.
Page 450 Troubleshooting and Diagnostics Section 10 Diagnostics Menu Figure 10.15 Third Diagnostics Menu Screen Third Diagnostics Menu Screen When the [MORE] key in the second DIAGNOSTICS MENU is pressed, the third DIAGNOSTICS MENU screen (see Figure 10.15) and the following soft key labels are displayed: SOFTWARE VERSION * DIGITAL READINGS *...
Page 451 Section 10 Troubleshooting and Diagnostics Figure 10.16 Voltage Readings Screen Voltage Readings When the [VOLTAGE READINGS] key is pressed, the voltage and vacuum/pressure value from a test point, measured at the moment when the key was pressed, is displayed. (See Figure 10.16.) The following additional soft key labels are displayed: FINISH SELECT * SELECT *...
Page 452 Troubleshooting and Diagnostics Section 10 Diagnostics Menu Fourth Diagnostics Menu Screen When the [MORE] key in the third DIAGNOSTICS MENU is pressed, the fourth DIAGNOSTICS MENU screen (see Figure 10.17) and the following soft key labels are displayed: RBC LIN DATA * WBC DATA * RBC DATA * PLT DATA *...
Page 453 Section 10 Troubleshooting and Diagnostics Fifth Diagnostics Menu Screen — CS Model For CS models, when the [MORE] key in the fourth DIAGNOSTICS MENU is pressed, the fifth and last DIAGNOSTICS MENU screen (see Figure 10.18) and the following soft key labels are displayed: SERIAL TEST BAR CODE ALIGNMENT * FPU TEST*...
Page 454 Troubleshooting and Diagnostics Section 10 Diagnostics Menu Serial Test The [SERIAL TEST] key is used to test the functionality of the COM1 port (referred to as the “serial interface connector”) at the rear of the instrument. This test is designed to assist in troubleshooting problems with interfacing to a Laboratory Information System (LIS).
Page 455 Section 10 Troubleshooting and Diagnostics Stop Transmiss The [STOP TRANSMISS] key is used to stop any transmission that is in progress to a LIS. When the key is pressed, any transmission in progress is aborted. Figure 10.20 Serial Test Transmit Message Screen Transmit Message When the [TRANSMIT MESSAGE] key is pressed, the message “CELL-DYN serial interface test”...
Page 456 Troubleshooting and Diagnostics Section 10 Diagnostics Menu Fifth Diagnostics Menu Screen — SL Model For SL models, when the [MORE] key in the fourth DIAGNOSTICS MENU is pressed, the fifth and last DIAGNOSTICS MENU screen (see Figure 10.21) and the following soft key labels are displayed: SERIAL TEST BAR CODE ALIGNMENT *...
Page 457 Section 10 Troubleshooting and Diagnostics Troubleshooting Guide Introduction to Troubleshooting Good troubleshooting skills are learned by using a logical, step-by-step approach to problem solving. The first step in the process is understanding normal instrument operation and preventative maintenance. A good working knowledge of the instrument is essential for identifying and resolving operational problems.
Page 458 United States: 1 (800) CELL DYN or 1 (800) 235-5396 Abbott Diagnostics Customer Support Center: 200 Abbott Park Road Abbott Park, Il 60064 Canada: 1(800) 387-8378 For customers outside the U.S., call your local Abbott Hematology Customer Support Representative. 10-24 CELL-DYN 3200 System Operator’s Manual ®...
Page 459 1. To correct a problem described in this section 2. At the request of an Abbott Customer Support Specialist. WARNING: Potential Biohazard. Follow established biosafety practices when performing maintenance, service or troubleshooting procedures.
Page 460 Troubleshooting and Diagnostics Section 10 Troubleshooting Procedures 6. Configure the RUN screen to display the appropriate graphic for the parameter(s) for which the background exceeds the specifications: Parameter Appropriate Graphic WBC histogram/scatterplots RBC and PLT histograms/scatterplots RBC and PLT histograms/scatterplots WBC, RBC and PLT histograms NOC histogram Obtain several printouts of this information by running multiple background...
Page 461 Section 10 Troubleshooting and Diagnostics Troubleshooting the “Sampling error-incomplete aspiration” Message 1. Check to see if the problem occurs in both the Open and Closed Modes of operation. If the problem is confined to one mode only, the other may be eliminated as the cause of the problem.
Page 462 Troubleshooting and Diagnostics Section 10 Troubleshooting Procedures 4. WBC: • Configure the RUN screen to display the following and obtain printouts by pressing the Print screen key on the keyboard. (This requires two printouts per sample.) Printout 1: Size-Cmp (0—10) Grn-Lob (90D—90) WBC 0—90 deg RBC 90—10 deg...
Page 463 Section 10 Troubleshooting and Diagnostics 6. NOC: • Follow the instructions given in step 5 for WBC, substituting the [NOC CNT] key for the [WOC CNT] key for displaying and printing rate and graph data. Troubleshooting Imprecise or Inaccurate Data –...
Page 464 Troubleshooting and Diagnostics Section 10 Troubleshooting Procedures NOTES 10-30 CELL-DYN ® 3200 System Operator’s Manual 9140181H—October 2001...
Page 465 Section 10 Troubleshooting and Diagnostics Instrument Conditions and Messages Overview Instrument conditions can be divided into two categories, those that generate messages, and those that do not. The messages will be displayed in the Status Box and/or the Bulletin Line. NOTE: For information on Suspect Parameter Flags, refer to Section 3: Principles of Operation;...
Page 466 Troubleshooting and Diagnostics Section 10 Instrument Conditions and Messages NOTES 10-32 CELL-DYN ® 3200 System Operator’s Manual 9140181H—October 2001...
Page 467: Table Of Contents
Section 10 Troubleshooting and Diagnostics Tables for Instrument Conditions and Messages Index of Table 10.1: Status Conditions Condition Page Ready/SB ................10-34 Selecting open/closed mode/SB .
Page 468: Ready/Sb
Troubleshooting and Diagnostics Section 10 Tables for Instrument Conditions and Messages Conditions Table 10.1 Status Each message is followed by one of the abbreviations shown below indicating where that message appears on the screen: BL — Bulletin Line SB — Status Box Ready/SB –...
Page 469: Clearing Fault/Sb
Section 10 Troubleshooting and Diagnostics Conditions (Continued) Table 10.1 Status Clearing fault/SB – – – – – – – – – – – – – – – – – Explanation/Action– – – – – – – – – – – – – – – – The [CLEAR FAULT] key was pressed after an operator-correctable fault was detected.
Page 470: No Entry Found/Bl
Troubleshooting and Diagnostics Section 10 Tables for Instrument Conditions and Messages Conditions (Continued) Table 10.1 Status No Entry Found/BL – – – – – – – – – – – – – – – – – Explanation/Action– – – – – – – – – – – – – – – – The number (sequence number or specimen ID number) entered on the DATA LOG SEARCH screen is not present in the data log.
Page 471: Loader Warning 145: Unload Area Full/Bl
Section 10 Troubleshooting and Diagnostics Conditions (Continued) Table 10.1 Status Loader Warning 145: unload area full/BL – – – – – – – – – – – – – – – – – Explanation/Action– – – – – – – – – – – – – – – – The unload area contains 5 racks.
Page 472 Troubleshooting and Diagnostics Section 10 Tables for Instrument Conditions and Messages Index of Table 10.2: General Fault Conditions Condition Page Not Ready: See DIAG or Not Ready: See Special/SB .........10-40 Uninitialized/SB .
Page 473 Section 10 Troubleshooting and Diagnostics Loader Fault 40: mix head stuck in angle position/BL......... 10-61 Loader Fault 41: mix head stuck in vertical position/BL .
Page 474: Not Ready: See Diag Or Not Ready: See Special/Sb
3. A Special Protocols procedure is in progress. MENU screen and perform the action necessary to complete the procedure. 4. System malfunction. 4. If the message occurs repeatedly, contact your Abbott Hematology Customer Support Center. 10-40 CELL-DYN ® 3200 System Operator’s Manual 9140181H—October 2001...
Page 475: Uninitialized/Sb
Section 5: Operating Instructions; Subsection: Operation Overview. If the Analyzer does not initialize, press the Print Screen key on the computer keyboard to document any screen messages, then contact your Abbott Hematology Customer Support Center. 10-41 CELL-DYN ® 3200 System Operator’s Manual...
Page 476: Printer (Graphics Or Ticket) Unavailable/Sb
Troubleshooting and Diagnostics Section 10 Tables for Instrument Conditions and Messages Table 10.2 General Fault Conditions (Continued) Printer (Graphics or Ticket) Unavailable/SB – – – - Probable Cause – – – – – – – - Corrective Action – – – 1.
Page 477: Diluent/Sheath, Hgb Lyse, Or Wbc Lyse Empty/Sb And Bl
7b.Verify tubings are fully inserted in solenoids 23, 25 (WBC Lyse) and 28, 24 (HGB Lyse). 8. Circuitry malfunction. 8. Contact your Abbott Hematology Customer Support Center. 10-43 CELL-DYN ® 3200 System Operator’s Manual...
Page 478: External Waste Full/Sb And Bl
4. Circuitry malfunction. 4. If the message appears repeatedly, contact your Abbott Hematology Customer Support Center. Shear valve position fault/BL – – – - Probable Cause – – – – – – – - Corrective Action – – –...
Page 479: Rbc Diluent Syringe Overpressure/Bl
1. Try to initialize the system. Sheath reagent distribution through the flow system. 2. If you cannot open Right Front Cover/Door contact your Abbott Hematology Customer Support Center. 3. If you can open the Right Front Cover/Door, remove the Diluent/...
Page 480: Flow Sequence Time Out /Bl
DIAGNOSTICS MENU screen. Continue processing samples. 3. If the problem recurs, contact your Abbott Hematology Customer Support Center. Command sent at incorrect time <x>/BL – – – - Probable Cause – – – – – – – - Corrective Action – – –...
Page 481: Data Acquisition Overlap/Bl
[INITIALIZATION] key on the second DIAGNOSTICS MENU screen. Continue processing samples. 3. If the fault recurs, contact your Abbott Hematology Customer Support Center. List mode data phase error/BL – – – - Probable Cause – – – – – – – - Corrective Action – – –...
Page 482: Runtime Error/Bl
[INITIALIZATION] key on the Data Module and Analyzer did not second DIAGNOSTICS MENU screen. communicate properly. If the fault recurs, power OFF and ON again. Contact your Abbott Hematology Customer Support Center if the message appears repeatedly. 10-48 CELL-DYN ®...
Page 483: Message Retransmission Failure/Bl
System. NOTE: If you wish to use the Sample Loader, reset the racks before initializing or rebooting the System. 2. If the message appears repeatedly, contact your Abbott Hematology Customer Support Center. 10-49 CELL-DYN ® 3200 System Operator’s Manual...
Page 484: Hssl Failure - Bad Incoming Messages/Bl
Components. NOTE: If you wish to use the Sample Loader, reset the racks before initializing or rebooting the System. 2. If the message appears repeatedly, contact your Abbott Hematology Customer Support Center. 10-50 CELL-DYN ® 3200 System Operator’s Manual 9140181H—October 2001...
Page 485: Hssl Failure - Bad Outgoing Commands/Bl
Components. NOTE: If you wish to use the Sample Loader, reset the racks before initializing or rebooting the System. 2. If the message appears repeatedly, contact your Abbott Hematology Customer Support Center. 10-51 CELL-DYN ® 3200 System Operator’s Manual 9140181H—October 2001...
Page 486: Hssl Failure - Receiver Hardware Error/Bl
Sample Loader, reset the racks before initializing or rebooting the System. 2. If the message appears repeatedly, contact your Abbott Hematology Customer Support Center. Monitor power-on self-test error/BL NOTE: This message pertains to a software execution monitor on the Analyzer, not the video display monitor.
Page 487: Missing Download Program/Bl
Sample Loader, reset the racks before rebooting the System. 2. If the message appears repeatedly, contact your Abbott Hematology Customer Support Center. Missing flow sequence/BL Flow sequence not present on Data Module. – – – - Probable Cause – – –...
Page 488: Dma Controller Error During List Mode Acquisition/Bl
Sample Loader, reset the racks before initializing or rebooting the System. 2. If the message appears repeatedly, contact your Abbott Hematology Customer Support Center. DMA controller setup error/BL A problem occurred during setup of the memory access controller. – – – - Probable Cause – – –...
Page 489: Download Program Timeout/Bl
Components. NOTE: If you wish to use the Sample Loader, reset the racks before initializing or rebooting the System. 2. If the message appears repeatedly, contact your Abbott Hematology Customer Support Center. 10-55 CELL-DYN ® 3200 System Operator’s Manual 9140181H—October 2001...
Page 490: Download Flow Sequence Timeout/Bl
System. 2. If the message appears repeatedly, contact your Abbott Hematology Customer Support Center. Command transmission timeout The Data Module did not receive acknowledgment of a command sent to the Analyzer within the allotted time.
Page 491: Message Reception Timeout/Bl
Sample Loader, reset the racks before initializing or rebooting the System. 2. If the message appears repeatedly, contact your Abbott Hematology Customer Support Center. Data acquisition timeout/BL The Analyzer exceeded the allotted time for data acquisition. – – – - Probable Cause – – –...
Page 492: Overflow In The Hssl Queue/Bl
Sample Loader, reset the racks before rebooting the System. 2. If the message appears repeatedly, contact your Abbott Hematology Customer Support Center. Analyzer is not communicating its mode/BL The Analyzer is not communicating whether it is an SL or CS model.
Page 493: Tower/Loader Fault 5: Communication Failure/Bl
Sample Loader, reset the racks before rebooting the System. 2. If the message appears repeatedly, contact your Abbott Hematology Customer Support Center. Tower/Loader Fault 16: direct command parameter error/BL The Analyzer command given to the module that controls the tower and loader is invalid.
Page 494: Tower/Loader Fault 17: Motor Command Timing Error/Bl
Sample Loader, reset the racks before rebooting the System. 2. If the message appears repeatedly, contact your Abbott Hematology Customer Support Center. Tower/Loader Fault 18: invalid direct command/BL The Analyzer command given to the module that controls the tower and loader is invalid.
Page 495: Tower/Loader Fault 19: Invalid Process Command/Bl
Sample Loader, reset the racks before rebooting the System. 2. If the message appears repeatedly, contact your Abbott Hematology Customer Support Center. Loader Fault 40: mix head stuck in angle position/BL The Mix Head failed to return to its vertical position.
Page 496: Loader Fault 41: Mix Head Stuck In Vertical Position/Bl
2. A failure of the magnetic reed sensor 2. If the message appears repeatedly, or related electronics has occurred. contact your Abbott Hematology Customer Support Center. Loader Fault 42: mix head not at top position/BL The Mix/Lift Assembly failed to reach its top position.
Page 497: Loader Fault 43: Mix Head Stuck At Top Position/Bl
2. A failure of the optical sensor or 2. If the message appears repeatedly, related electronics has occurred. contact your Abbott Hematology Customer Support Center. Loader Fault 44: load zone empty detector malfunction The system failed to retract mechanical arms after detecting that the load zone is empty.
Page 498: Loader Fault 45: Unload Zone Full Detector Malfunction/Bl
2. A failure of the sensor or sample 2. If the message appears repeatedly, loader mechanics has occurred. contact your Abbott Hematology Customer Support Center. Loader Fault 46: unload zone nearly full detector malfunction/BL The system is detecting an unload zone nearly full condition (4 racks in unload zone) even though there are fewer than 4 racks in the unload zone.
Page 499: Loader Fault 47: Tube Stuck In Position 3/Bl
Section 10 Troubleshooting and Diagnostics Table 10.2 General Fault Conditions (Continued) Listed are Sample Loader-related error messages referring to tube positions 3 and 4, which are Mixing Stations 1 and 2 respectively. (Refer to Figure 13.7.) Loader Fault 47: tube stuck in position 3/BL The sensor for tube position 3 in the mixing zone is sensing the presence of a tube when the tube should be lifted clear of the rack by the Mix Head –...
Page 500 Section 13: Sample Loader; Subsection: Processing Stations. 3. A failure of the sensor or related 3. If the message appears repeatedly, electronics has occurred. contact your Abbott Hematology Customer Support Center. 10-66 CELL-DYN ® 3200 System Operator’s Manual 9140181H—October 2001...
Page 501: Loader Fault 48: Tube Stuck In Position 4/Bl
Section 10 Troubleshooting and Diagnostics Table 10.2 General Fault Conditions (Continued) Loader Fault 48: tube stuck in position 4/BL The sensor for tube position 4 in the mix zone is sensing the presence of a tube when the tube should be lifted clear of the rack. –...
Page 502: Tower Fault 49: Tower Cover Open/Bl
3. A failure of the sensor or related 3. If the message appears repeatedly, electronics has occurred. contact your Abbott Hematology Customer Support Center. Tower Fault 49: tower cover open/BL The circuit formed when the Tower Cover is in place has been broken.
Page 503: Tower Fault 50: Probe Stuck At Home Position/Bl
2. Reset the racks and reset the electronics has occurred. Sample Loader. 3. The tower, motor, or related 3. If the message appears repeatedly, electronics is defective. contact your Abbott Hematology Customer Support Center. 10-69 CELL-DYN ® 3200 System Operator’s Manual...
Page 504: Tower Fault 100: Probe Unable To Reach Home Position/Bl
2. Reset the racks and reset the electronics has occurred. Sample Loader. 3. The tower, tower motor, or related 3. If the message appears repeatedly, electronics is defective. contact your Abbott Hematology Customer Support Center. 10-70 CELL-DYN ® 3200 System Operator’s Manual...
Page 505: Tower Fault 141: Invalid Tube Height/Bl
Section 10 Troubleshooting and Diagnostics Table 10.2 General Fault Conditions (Continued) Tower Fault 141: invalid tube height/BL The tube height sensor system indicates that the tube at the Aspiration Station exceeds height specification. – – – - Probable Cause – – – –...
Page 506: Tower Fault 142: No Tube Present/Bl
Then, reinstall the Loader Cover, reset the racks, and reset the Sample Loader. c. The tube height sensor flag is c. Contact your Abbott bent or the tower sensors, motor, Hematology Customer Support or related electronics are Center.
Page 507: Loader Warning 144: Excessive Cycling/Bl
Section 13: Sample Loader; Subsection: Processing Stations. 4. A failure of the sensor or related 4. If the message appears repeatedly, electronics, or loader mechanisms contact your Abbott Hematology has occurred. Customer Support Center. 10-73 CELL-DYN ® 3200 System Operator’s Manual...
Page 508: Loader Fault 147: Unload Area Hardware Malfunction/Bl
2. A failure of the sensor system or 2. Reset the racks and reset the related electronics has occurred. Sample Loader. If the message appears repeatedly, contact your Abbott Hematology Customer Support Center. 10-74 CELL-DYN ® 3200 System Operator’s Manual...
Page 509: Loader Fault 148: Tube Dropped During Mixing/Bl
NOTE: For the location of the tube sensors, refer to the figure in Section 13: Sample Loader; Subsection: Processing Stations. 3. A failure of the bladder or bladder 3. Contact your Abbott Hematology pressure system has occurred. Customer Support Center. 10-75 CELL-DYN ®...
Page 510: Loader Fault 149: Mix Zone Rack Position Error/Bl
[CLEAR FAULT], [START LOADER], [RESET LOADER]. c. A failure of the Air Cylinder or c. If the message appears the Air Cylinder pressure system repeatedly, contact your Abbott has occurred. Hematology Customer Support Center. 10-76 CELL-DYN ®...
Page 511: Loader Fault 150: Unexpected Tube In Position 4 After Rack Advance/Bl
[START LOADER], [RESET LOADER]. c. A failure of the Air Cylinder or c. If the message appears the Air Cylinder pressure system repeatedly, contact your Abbott has occurred. Hematology Customer Support Center. 2. Tube sensor in position 3 is dirty.
Page 512: Loader Fault 151: Tube Lost Moving From Position 3 To 4/Bl
[START LOADER], [RESET LOADER]. c. A failure of the Air Cylinder or c. If the message appears the Air Cylinder pressure system repeatedly, contact your Abbott has occurred. Hematology Customer Support Center 2. Tube sensor in position 4 is dirty.
Page 513: Loader Fault 152: Mix Zone Must Be Cleared For Reset/Bl
Loader Cover, reset the racks, and reset the Sample Loader. 4. A failure of the sensor system or 4. If the message appears repeatedly, related electronics has occurred. contact your Abbott Hematology Customer Support Center. 10-79 CELL-DYN ® 3200 System Operator’s Manual...
Page 514: Loader Fault 153: Rack Bar Code Read Failure/Bl
Sample Loader by pressing the [RESET LOADER] key was following keys in order: [CLEAR FAULT], pressed. [START LOADER], [RESET LOADER]. If the message appears repeatedly, contact your Abbott Hematology Customer Support Center. 10-80 CELL-DYN ® 3200 System Operator’s Manual 9140181H—October 2001...
Page 515: Loader Fault 154: Tube Position Bar Code Read Failure/Bl
2. Clean or replace the tube position scuffed or dirty. bar code label. Then, reset the racks and reset the Sample Loader. If the message appears repeatedly, contact your Abbott Hematology Customer Support Center. 10-81 CELL-DYN ® 3200 System Operator’s Manual...
Page 516: Loader Fault 156: Bar Code Reader Failure/Bl
3. Reset the racks and reset the disconnected, or the Bar code Sample Loader. If the message Reader or related electronics has appears repeatedly, contact your failed. Abbott Hematology Customer Support Center. 10-82 CELL-DYN ® 3200 System Operator’s Manual 9140181H—October 2001...
Page 517 Section 10 Troubleshooting and Diagnostics Index of Table 10.3: Sample-Related Fault Conditions Condition Page Sampling Error — Incomplete Aspiration/BL ..........10-84 3 consecutive incomplete aspirations/BL .
Page 518: Sampling Error - Incomplete Aspiration/Bl
Section 9: Service and Maintenance; Subsection: Shear Valve Cleaning. 4. Clean the Y valve as directed in Section 9: Service and Maintenance; Subsection: Nonscheduled Maintenance Procedures. 5. Contact your Abbott Hematology Customer Support Center. 10-84 CELL-DYN ® 3200 System Operator’s Manual 9140181H—October 2001...
Page 519: Consecutive Incomplete Aspirations/Bl
RUN screen. The Sample Loader continues processing. 3. If unable to resolve this problem, contact your Abbott Hematology Customer Support Center. WOC Flow Error/BL WOC FLOW ERROR is displayed on the RUN screen to the right of the EOS results.
Page 520: Noc Flow Error/Bl
Troubleshooting and Diagnostics Section 10 Tables for Instrument Conditions and Messages Table 10.3 Sample-Related Fault Conditions NOC Flow Error/BL NOC FLOW ERROR is displayed on the RUN screen under the BASO result. “NOC FLOW ER” is printed on the graphics report to the right of the LYM result. Results for WBC and Differential are suppressed.
Page 521: Rbc Flow Error/Bl
Loader operation. Loader to halt. Refer to the three previous messages and Troubleshooting Tips and Techniques earlier in this section. 2. If unable to resolve this problem, contact your Abbott Hematology Customer Support Center. 10-87 CELL-DYN ® 3200 System Operator’s Manual...
Page 522: In Place Of Results For Wbc, Rbc, Hgb Or Plt
4. Debris is present in the system. menu screen, perform an [AUTO CLEAN] and/or [EXTENDED AUTOCLEAN] cycle to clean the system. 5. Optical gains have shifted. 5. Contact your Abbott Hematology Customer Support Center. 10-88 CELL-DYN ® 3200 System Operator’s Manual...
Page 523 Section 10 Troubleshooting and Diagnostics Index of Table 10.4: Non-Functional Fault Conditions Condition Page Analyzer will not power ON............. 10-90 No screen display on the Display Monitor.
Page 524: Analyzer Will Not Power On
Check the fuse as directed in the Section 9: Service and Maintenance; Subsection: Fuse Replacement. 4. Defective power switch or other 4. Contact your Abbott Hematology system malfunction. Customer Support Center. 10-90 CELL-DYN ®...
Page 525: No Screen Display On The Display Monitor
NOTE: For the location of the VGA connector, refer to Section 1: Use or Function; Subsection: Data Module Components. 4. Defective Display Monitor or other 4. Contact your Abbott Hematology component. Customer Support Center. 10-91 CELL-DYN ® 3200 System Operator’s Manual...
Page 526: The Message "Please Check Signal Cable" Appears On The Display Monitor
Rear Panel of the Data Module. Reseat the cable and secure the connection properly. 2. Defective Data Module component. 2. Contact your Abbott Hematology Customer Support Center. 10-92 CELL-DYN ® 3200 System Operator’s Manual...
Page 527: Background Count Is Outside Acceptable Limits
Section 10 Troubleshooting and Diagnostics Table 10.4 Non-Functional Fault Conditions (Continued) Background count is outside acceptable limits – – – - Probable Cause – – – – – – – - Corrective Action – – – 1. In the second SPECIAL PROTOCOLS 1.
Page 528: The Pc Keyboard Is Not Operational
– – – - Probable Cause – – – – – – – - Corrective Action – – – 1. The internal power cord connecting 1. Contact your Abbott Hematology the Sample Loader to the Analyzer Customer Support Center. is loose or disconnected.
Page 529: The Sample Loader Beeps But Does Not Begin Processing
– – – - Probable Cause – – – – – – – - Corrective Action – – – 1. The internal cable that connects the 1. Contact your Abbott Hematology Sample Loader to the Analyzer is Customer Support Center.
Page 530 Troubleshooting and Diagnostics Section 10 Tables for Instrument Conditions and Messages NOTES 10-96 CELL-DYN ® 3200 System Operator’s Manual 9140181H—October 2001...
Page 531 Control Guide. The Quality Control Menu describes the functions of the keys in the QC MENU. The Quality Control Guide discusses the interpretation of QC data. QC Options The CELL-DYN 3200 offers several Quality Control options to monitor and validate instrument performance. The options are: X-B Analysis —...
Page 532 Quality Control Section 11 Overview NOTES 11-2 CELL-DYN ® 3200 System Operator’s Manual 9140181H—October 2001...
Page 533 Section 11 Quality Control Quality Control Menu QC Menu Softkeys This section discusses the options available when the [QUALITY CONTROL] key is pressed. The options used to set up the QC Files are available from the QUALITY CONTROL menu (see Figure 11.1) and the QC SET UP menu. Refer to Set Up QC File in Section 5: Operating Instructions for an explanation of these keys as they will not be discussed in this section.
Page 534 Quality Control Section 11 Quality Control Menu X-B Set Up Figure 11.2 X-B Set Up Screen The following soft key labels are displayed when the [X-B SET UP] key is pressed (refer to Figure 11.2): TURN X-B RBC OFF (Key label alternates between ON/OFF selections) TURN X-B WBC OFF (Key label alternates between ON/OFF selections) PRINT RETURN...
Page 535 Section 11 Quality Control X-B File Figure 11.3 X-B RBC Graphs Screen The following soft key labels are displayed when the [X-B FILE] key is pressed: X-B RBC DATA/GRAPHS (Key label alternates between selections) X-B WBC DATA/GRAPHS (Key label alternates between selections) PRINT RETURN For a description of how the X-B Program works, refer to X-B Program Operation...
Page 536 Quality Control Section 11 Quality Control Menu Figure 11.4 X-B RBC Data Screen Print The [PRINT] key is used to print the X-B data or graphs. When this key is pressed, the data for all 20 batches is automatically printed if the data is displayed. If the graphs are displayed, all ten of them are printed.
Page 537 Section 11 Quality Control View QC Log The [VIEW QC LOG] key is used to display the QC Log indicated by the position of the cursor. Figure 11.5 The View QC Log Screen Each QC Log display shows the following information (see Figure 11.5): 1.
Page 538 Quality Control Section 11 Quality Control Menu 4. The remainder of the screen displays the file information and the data. The UPPER and LOWER LIMITS and TARGET MEAN entered are displayed immediately above the parameter names. The sequence number for each result is displayed to the left of the data.
Page 539 Section 11 Quality Control Purge QC Log The [PURGE QC LOG] key is used to delete the contents of the QC Log. When the [PURGE QC LOG] key is pressed, the following soft key labels are displayed: &ONFIRM PURGE CANCEL PURGE These keys are used to [CONFIRM] or [CANCEL] the Purge QC Log command.
Page 540 Quality Control Section 11 Quality Control Menu Figure 11.7 The Levey-Jennings Menu Screen Showing Next 10 Group Each of the Group keys is used to select the graphs for a group of data that correspond to the groups selected in the Customize QC Display option. Subsequent groups may be selected by pressing the appropriate soft keys.
Page 541 Section 11 Quality Control Figure 11.8 QC Log Screen With Rejected Results When the [ACCEPT SPECIMEN] key is pressed, the “R” is deleted and the statistics are recomputed including those results. Delete Specimen The [DELETE SPECIMEN] key is used to delete the results for the specimen indicated by the cursor position.
Page 542 Quality Control Section 11 Quality Control Menu Move Specimen Procedure 1. From the QC MENU screen, use the Arrow keys on the keyboard to move the cursor to the file containing the specimen to be moved. 2. Press [VIEW QC LOG]. 3.
Page 543 Section 11 Quality Control 8. Repeat steps 3-6 to write additional desired QC file levels to disk. NOTE: The disk can store one QC file of each level. If more than one QC file of each level is saved, the new data will overwrite the previous data.
Page 544 Quality Control Section 11 Quality Control Menu NOTES 11-14 CELL-DYN ® 3200 System Operator’s Manual 9140181H—October 2001...
Page 545 The second part discusses the Westgard ® Rules used on the CELL-DYN 3200 System and gives guidance for their application in the hematology laboratory. The third part discusses the X-B Analysis program in monitoring quality control.
Page 546 Quality Control Section 11 Quality Control Guide Assay Verification New lots of control material should be analyzed in parallel with current lots prior to their expiration dates. Perform the following steps to accomplish the transition to a new lot: 1. Set up a control file for the new lot. 2.
Page 547 Running Controls Abbott recommends using CELL-DYN Control materials for performing Quality Control checks on the CELL-DYN 3200 System. Run a minimum of two levels of control at the beginning of each eight hours of operation prior to running patient samples. In addition, run controls after the following events: •...
Page 548 Overview A control rule tests the control result against control limits to determine whether the CELL-DYN 3200 shows acceptable accuracy and precision. The limits are derived from the mean and standard deviation of control measurements obtained when instrument performance is stable and acceptable. The most common rule used in Hematology Quality Control is the mean ±...
Page 549 Section 11 Quality Control The rules may be used singly or in combination depending on operator preference. Selections are made on the QC FILE SET UP screen. When a rule is selected, a plus sign is displayed to the right of the parameter name on the LEVEY-JENNINGS MENU screens.
Page 550 If a combination of rules has been violated across the three levels, determine whether the violations indicate a loss of precision or a loss of accuracy and troubleshoot accordingly. If necessary, call the Abbott Hematology Customer Support Center for assistance.
Page 551 Section 11 Quality Control Laboratories seeing specialized patient populations, e.g. pediatric hospitals or tumor centers, may need to verify these values due to “abnormal” patient populations. Target values may be verified by evaluating approximately 500 samples and comparing the X-B means for those samples to the entered target values.
Page 552 Quality Control Section 11 Quality Control Guide 12. In the Data Log, the X-B flag "r" refers to RBC, flag "w" refers to WBC, and flag "b" means the specimen has been included in both the RBC and WBC batches. 13.
Page 553 The X-B algorithm provides a means of utilizing this information for quality control on the CELL-DYN 3200 System. The X-B algorithm analyzes the indices on the patient samples run through the instrument in batches of 20. The mean of each batch is compared to a target value, and a percent deviation is computed and compared to the acceptable limits.
Page 554 Quality Control Section 11 Quality Control Guide Collect data from 25 batches of 20 specimens each for a total of 500 specimens. Data collection should be from specimens which represent the typical specimen population that is processed through the instrument. When all 25 batches are complete, print the X-B DATA DISPLAY screen for RBC.
Page 555 High High HGB/HCT will be If all efforts fail to bring results within acceptable limits, contact the Abbott Hematology Customer Support Center (at 1-800-CELL-DYN in the U.S.) for assistance. Customers outside the U.S. contact your local Hematology Customer Support Center.
Page 556 Quality Control Section 11 Quality Control Guide Establishing the X-B WBC Target Value The Target Values for X-B WBC can be established in the same way as the Target Values for the RBC indices. Each laboratory should establish its own target value for the X-B WBC parameters. It is suggested that the process be started by using the default (preset) values displayed in the following table.
Page 557 Section 11 Quality Control References 1. Cembrowski GS, Carey RN. Laboratory quality management, p. 189. 2. Westgard JO et al. A multi-rule Shewhart chart for quality control in clinical chemistry. Clin Chem 1981; 27:3:493–501. 3. Cembrowski GS, et al. Use of a multirule control chart for the quality control of PT and APTT analyses.
Page 558 Quality Control Section 11 References NOTES 11-28 CELL-DYN ® 3200 System Operator’s Manual 9140181H—October 2001...
Page 559 If ticket printing is desired for the CELL-DYN 3200, a second printer (known as the Ticket Printer) can also be connected to the system at the same time as the Graphics Printer.
Page 560 Printers Section 12 Overview NOTES 12-2 CELL-DYN ® 3200 System Operator’s Manual 9140181H—October 2001...
Page 561 Troubleshooting Refer to the printer manuals for a list of the most common printer problems and how to solve them. If the problem is not resolved, contact the Abbott Hematology Customer Support Center for assistance. If, during routine system operation, the message PRINTER UNAVAILABLE is...
Page 562 Printers Section 12 Maintenance and Troubleshooting NOTES 12-4 CELL-DYN ® 3200 System Operator’s Manual 9140181H—October 2001...
Page 563 Printers Routine Operation Graphics Printer The CELL-DYN 3200 software automatically controls and adjusts most print conditions, including page width. If printing is not what you expect, refer to the printer manual for guidance in making adjustments. If you have additional questions or experience any problems, call the Abbott Hematology Customer Support Center for assistance.
Page 564 Printers Section 12 Routine Operation 5. Raise the separator to its upright position. 6. Place a ticket on the paper separator and adjust the guides so that they barely touch the edges of the ticket. 7. Pull the bail lever forward. The ticket will automatically feed into place. Release the paper bail lever.
Page 565 Section 13 Sample Loader Section 13 Sample Loader Overview The Sample Loader for the CELL-DYN 3200SL is an automated microprocessor- based sample-handling system designed to be attached to the Analyzer (see Figure 13.1). The Sample Loader delivers mixed blood samples to the Analyzer for analysis and communicates sample identification information and the loader’s operational status to the CELL-DYN 3200SL.
Page 566 Sample Loader Section 13 Overview NOTES 13-2 CELL-DYN ® 3200 System Operator’s Manual 9140181H—October 2001...
Page 567 Section 13 Sample Loader Physical and Performance Specifications Specifications Refer to Section 4: Performance Characteristics and Specifications for complete performance specifications for the CELL-DYN 3200SL. The following information on the Sample Loader is included here for convenience. Dimensions and Weight Height 6 in (15.2 cm) Width...
Page 568 Sample Loader Section 13 Physical and Performance Specifications NOTES 13-4 CELL-DYN ® 3200 System Operator’s Manual 9140181H—October 2001...
Page 569 3 Sample Transport 4 Station 1 (tube position 3) 5 Station 2 (tube position 4) 6 Bar Code Reader 7 Tube Grippers (under Mixing Block) Figure 13.2 CELL-DYN 3200 Sample Loader 13-5 CELL-DYN ® 3200 System Operator’s Manual 9140181H—October 2001...
Page 570 Sample Loader Section 13 Sample Loader Description The Sample Transport Assembly consists of pneumatic-actuated arms that move the racks in an orderly process through the sample mixing, bar code reading, and aspiration stages of the processing cycle. There are two Sample Tube Sensors at the two Sample Mixing Stations. The sample tube is sensed at the first sample Mixing Station (tube position 3) and again at the second Sample Mixing Station (tube position 4).
Page 571 Section 13 Sample Loader Figure 13.3 Tube Labeling Requirements Rack Labels Every rack and tube position is identified by a bar code label. (See Figure 13.4.) Bar code labels on tube racks are essential for proper Sample Loader operation. The rack label must be placed on each rack ahead of tube position 1. This label serves to identify the rack and tube position 1.
Page 572 Sample Loader Section 13 Sample Loader Description Figure 13.4 Rack with Bar Code Labels ≥ NOTE: Tube bar code labels must be 3 digits. Rack labels must include Code 39. The Rack ID must be 2 digits, and the rack position must be 1 digit. 13-8 CELL-DYN ®...
Page 573 Section 13 Sample Loader RUN Screens The RUN Screens for the CELL-DYN 3200SL model, shown in Figures 13.5 and 13.6, are slightly different from the screen for the CELL-DYN 3200CS model. Figure 13.5 CELL-DYN 3200SL RUN Screen 13-9 CELL-DYN ® 3200 System Operator’s Manual 9140181H—October 2001...
Page 574 Sample Loader Section 13 Sample Loader Description Figure 13.6 Sample Loader Restart Screen Soft Keys Overview The soft key menu on the CELL-DYN 3200SL model is similar to the menu on the CELL-DYN 3200CS model except for the following: 1. The [START LOADER/STOP LOADER] key in the first position (refer to Figure 13.5).
Page 575 Section 13 Sample Loader Start Loader Pressing the [START LOADER] key displays the RESTART menu shown in Figure 13.6 (the Sample Loader remains inactive) under the following two conditions: 1. When the [STOP LOADER] key was pressed while the Sample Loader was operating 2.
Page 576 Sample Loader Section 13 Sample Loader Description Reset Loader The [RESET LOADER] key should be used to activate the Sample Loader under the following conditions: 1. When the [STOP LOADER] key was pressed and the rack under the Tower was subsequently moved 2.
Page 577 Section 13 Sample Loader Sample Loader Faults - Resume Loader Some Sample Loader-only faults do not require the Sample Loader to be re- initialized. In these cases, when the operator presses the [CLEAR FAULT] key followed by [START LOADER], a submenu is displayed showing both the [RESUME LOADER] and [RESET LOADER] keys as well as [RETURN].
Page 578 Sample Loader Section 13 Sample Loader Description 1 Tube Sensors (behind Stations 1 & 2) 2 Station 1 (tube position 3) 3 Station 2 (tube position 4) 4 Station 3 5 Bar Code Reader Figure 13.7 Sample Loader Stations Rack Movement The tube racks move from the load side, through the mixing and aspiration stations, to the unload side (refer to Figure 13.8).
Page 579 Section 13 Sample Loader 1 Rack Advance 2 Unload Side 3 Racks are pushed away from the Analyzer 4 Load Side 5 Racks are pushed toward the Analyzer 6 Aspiration Needle 7 Mixing Block 8 Station 1 9 Station 2 10 Station 3 11 Bar Code Reader Figure 13.8 Rack Movement...
Page 580 Sample Loader Section 13 Sample Loader Description If a malfunction occurs at the Mixing or Aspiration Stations, the Sample Loader halts operation and emits a beep to alert the operator. The [CLEAR FAULT] key is displayed, and a fault message is displayed on the bulletin line. Unload Side When the rack reaches the edge of the left side, a mechanical arm pushes the rack toward the front of the Sample Loader to make room for the next rack being...
Page 581 Section 13 Sample Loader Sample Identification Each rack must have a legible bar code label. If a rack has no bar code label or if the label cannot be read by the Bar Code Reader, the Sample Loader stops, and the message Loader Fault 153: rack barcode read failure is displayed on the bulletin line.
Page 582 Sample Loader Section 13 Sample Loader Description b. DO NOT move the remaining tubes in the rack, otherwise Work List entries will also have to be changed to reflect the new rack and tube positions of the remaining samples. Place the rack in the starting position.
Page 583 Section 13 Sample Loader Sample Loader Operation Prior to activating the Sample Loader, racks containing tubes to be processed should be placed on the load side of the Sample Loader (refer to Figure 13.8). Sample Loader Cycle The following sequence is a basic description of the events that occur from the time that the instrument is turned ON through the complete processing cycle.
Page 584 Sample Loader Section 13 Sample Loader Operation 6. When a tube has been properly mixed, it moves to the Vent/Aspiration Station (Station 3). a. When the Needle begins to move down, the Spinning Assembly moves down to (a) position the tube so that the stopper is pierced at or near the center, and to (b) rotate the tube so that the bar code can be read.
Page 585 Section 13 Sample Loader Operating Procedures 1. Press the [START LOADER] key in the RUN menu. Based on which condition exists (refer to the Sample Loader Description, Soft Keys subsection), either the Sample Loader will be activated or a submenu will be displayed. 2.
Page 586 Sample Loader Section 13 Sample Loader Operation NOTES 13-22 CELL-DYN ® 3200 System Operator’s Manual 9140181H—October 2001...
Page 587 Section 13 Sample Loader Routine Operating Procedures Installation For detailed instructions on how to install the SL model, refer to Section 2: Installation Procedures and Special Requirements. Running Samples Instructions for Routine Operation of the CELL-DYN 3200SL model are given in Section 5: Operating Instructions.
Page 588 Sample Loader Section 13 Routine Operating Procedures NOTES 13-24 CELL-DYN ® 3200 System Operator’s Manual 9140181H—October 2001...
Page 589 Section 14 Reticulocyte Package Overview The Reticulocyte Package software enables the operator of the CELL-DYN 3200 System to analyze a whole blood specimen for reticulocytes. The Reticulocyte specimen is prepared by using reticulocyte reagent to produce a diluted, stained sample. Reticulocyte specimens can be run as batches, or they can be run on a STAT basis.
Page 590 Reticulocyte Package Section 14 Overview NOTES 14-2 CELL-DYN ® 3200 System Operator’s Manual 9140181H—October 2001...
Page 591 RNA. This RNA can be seen with certain supravital, cationic dyes that simultaneously stain and precipitate the polyanion to form a network or reticulum. The CELL-DYN 3200 System reticulocyte method uses the thiazine dye New Methylene Blue N. The reticulocyte assay is performed in the WOC channel of the instrument.
Page 592 Reticulocyte Package Section 14 Principles of Operation Flowchart Conventions Menus are shown as square-cornered rectangles in the flowcharts, and soft keys are shown as round-cornered rectangles: MAIN MENU Ready SPECIAL SET UP DATA LOG RETIC QUALITY CALIBRATION DIAG- DATA LOG CONTROL NOSTICS PROTOCOLS...
Page 593 Section 14 Reticulocyte Package 14-5 CELL-DYN ® 3200 System Operator’s Manual 9140181H—October 2001...
Page 594 Reticulocyte Package Section 14 Principles of Operation NOTES 14-6 CELL-DYN ® 3200 System Operator’s Manual 9140181H—October 2001...
Page 595 Section 14 Reticulocyte Package Retic Menu Options This section discusses the operation of the Reticulocyte Package. It contains the following subsections: • Turning the Reticulocyte Package ON and OFF • RETIC MAIN Menu • RETIC SET UP Menu • RETIC DATA LOG Menu •...
Page 596 Reticulocyte Package Section 14 Retic Menu Options Turning the Reticulocyte Package ON and OFF Turning ON the Reticulocyte Package The [TURN ON RETIC PKG] key is located on the OPERATION SET UP MENU screen (see Figure 14.1), which is accessed from the SET UP screen. The Reticulocyte Package software is enabled when the [TURN ON RETIC PKG] key is pressed.
Page 597 2. From the OPERATION SET UP MENU screen, press the [TURN ON RETIC PKG] key to enable the Reticulocyte Package. 3. The RETIC MAIN menu screen displays. The software to analyze reticulocytes is now enabled on the CELL-DYN 3200 System. 14-9 CELL-DYN ®...
Page 598 Reticulocyte Package Section 14 Retic Menu Options Turning OFF the Reticulocyte Package The [TURN OFF RETIC PKG] key is located on the RETIC OPERATION SET UP MENU screen (see the Figure 14.2), which is accessed from the RETIC SET UP screen. The Reticulocyte Package software is disabled when the [TURN OFF RETIC PKG] key is pressed.
Page 599 Reticulocyte Package. The instrument automatically rinses, runs a background, and returns to the Standard Hematology Software. 3. The MAIN MENU displays. The software to analyze reticulocytes is now disabled on the CELL-DYN 3200 System. 14-11 CELL-DYN ®...
Page 600 Reticulocyte Package Section 14 Retic Menu Options Retic Main Menu 18:27 Feb 23 2001 SYSTEM 2.0 CD3200 RETIC MAIN MENU Operator ID Ready Retic Seq# RETIC RETIC RETIC DATA LOG RETIC RETIC RETIC SP SET UP DATA LOG DIAGNOSTIC PROTOCOLS Figure 14.3 Reticulocyte Main Menu Screen The upper left-hand corner of the RETIC MAIN menu screen shows the current revision of the instrument software.
Page 601 Section 14 Reticulocyte Package The following soft key labels are displayed on the RETIC MAIN menu screen: RETIC SET UP RETIC RUN RETIC DATA LOG DATA LOG RETIC QC RETIC DIAGNOSTIC RETIC SP PROTOCOLS The RETIC RUN menu is described in Routine Operation later in this chapter. 14-13 CELL-DYN ®...
Page 602 Reticulocyte Package Section 14 Retic Menu Options Retic Set Up Menu CD3200 RETIC MAIN MENU RETIC SET UP DATE/ RETIC QC CUSTOMIZE RETIC PT REAGENT OPERATION UNITS RETIC TIME SET UP SELECTION REPORT LIMITS SET UP MAIN SAME KEYS SAME KEYS AS IN AS IN HEMATOLOGY...
Page 603 Section 14 Reticulocyte Package The following soft keys are displayed on the RETIC SET UP menu screen: DATE/TIME RETIC PT LIMITS* REAGENT LOG RETIC QC SET UP* OPERATION SET UP* UNITS SELECTION CUSTOMIZE REPORT RETIC MAIN* * These soft keys are described in this section as they appear from left to right on the screen.
Page 604 Reticulocyte Package Section 14 Retic Menu Options 18:36 Feb 23 2001 LIMIT SET 1 Operator ID Ready Req Seq# Lower Limits Upper Limits RETIC% 0.00 35.0 RETIC ABS K/uL 1500 K/uL 0.00 M/uL 9.99 M/uL LIMIT LIMIT LIMIT LIMIT LIMIT PRINT RETURN SET 2...
Page 605 Section 14 Reticulocyte Package 5. Press the appropriate soft key to select another Limit Set and repeat steps 2– 4 to enter the desired limits. 6. Press the [RETURN] key to return to the RETIC SET UP menu. Retic QC Set Up 18:39 Feb 23 2001 RETIC QC LOG...
Page 606 Reticulocyte Package Section 14 Retic Menu Options Retic QC Limits The [RETIC QC LIMITS] key is used to display the RETIC QC RANGE ENTRY screen or the RETIC QC MEANS/LIMITS screen, and the following soft key labels: MEANS/LIMITS or RANGE ENTRY (This key label alternates between these two selections.) UPDATE FROM FILE...
Page 607 Section 14 Reticulocyte Package 18:50 Feb 23 2001 RETIC QC MEANS/LIMITS Operator ID Ready R0001 Req Seq# FOR FILE 1 Means Limits (+/-) RETIC% 5.00 1.00 RANGE UPDATE LOAD PRINT RETURN ENTRY FROM FILE FROM DISK Figure 14.8 Retic QC Means/Limits Screen QC Limits are entered by selecting the QC file from the RETIC QC LOG screen (by moving the cursor to the desired QC file) and pressing the [RETIC QC LIMITS] key.
Page 608 Reticulocyte Package Section 14 Retic Menu Options Procedure: Range Entry 1. Select a file from the RETIC QC LOG screen by using the arrow keys on the keyboard to move the cursor to the desired file. 2. Press the [RETIC QC LIMITS] key and if necessary press the [RANGE ENTRY] key to display the RETIC QC RANGE ENTRY screen for the selected file.
Page 609 Section 14 Reticulocyte Package The Westgard ® Rules are discussed in detail in Section 11: Quality Control. 19:00 Feb 23 2001 QC FILE SET UP Operator ID Ready R0001 Req Seq# FOR FILE 1 Lot Number: _ _ _ _ _ _ _ Expiration Date (Month/Day/Year): _ _/_ _/_ _ WESTGARD RULE SELECTION:...
Page 610 Reticulocyte Package Section 14 Retic Menu Options Operation Set Up Soft Key 19:02 Feb 23 2001 OPERATION SET UP MENU Operator ID Ready R0001 Req Seq# TURN OFF LANGUAGE SELECT BAR CODE COMPUTER RETURN RETIC PKG COLOR SET UP SET UP Figure 14.10 Operation Set Up Menu Screen with Reticulocyte Package Enabled The [OPERATION SET UP] key on the RETIC SET UP menu is used to display the OPERATION SET UP MENU screen.
Page 611 Section 14 Reticulocyte Package Units Selection 19:05 Feb 23 2001 UNITS SELECTION Operator ID Ready R0001 Req Seq# Parameters SI MOD SET1 SET2 10e3/µL 10e2/µL 10e9/L K/µL 10e6/µL 10e4/µL 10e12/L M/µL mmol/L g/dL g/dL 10e3/L 10e4/µL 10e9/L K/µL mL/L mL/L 10e3/L 10e4/µL 10e9/L...
Page 612 Reticulocyte Package Section 14 Retic Menu Options Procedure: Units Selection 1. From the RETIC SET UP menu, press the [UNITS SELECTION] key. 2. Choose one of the following two options: • To select a predefined set of units, press the appropriate soft key. The group of selected units is highlighted on the screen.
Page 613 RBC value, Reticulocyte Absolute Number, and Reticulocyte Flags) and all patient demographic information in a log format for each of the most current 2,000 Reticulocyte cycles run on the CELL-DYN 3200 System. The record information is stored chronologically by Reticulocyte Sequence Number. Each Reticulocyte Sequence Number will have an “R”...
Page 614 Reticulocyte Package Section 14 Retic Menu Options 15:25 Aug 02 2001 RETIC DATA LOG Operator ID Ready R0483 Req Seq# Date Time Op Seq Specimen ID COUNT RTC% RABS R469 BACKGROUND O04/16/01 09:17 TS R470 PG041-1 K04/17/01 06:26 TS 1.34 R471 PG041-2 5.84...
Page 615 Section 14 Reticulocyte Package Retic Data Log Codes The following letters are displayed on the RETIC DATA LOG screen in the column immediately preceding the date. (See the preceding figure.) Sample was run in the Open Mode. Flow Error or Fragile RBCs. NOTE: Reticulocyte results are not suppressed for Fragile RBCs but are suppressed for Flow Errors.
Page 616 Reticulocyte Package Section 14 Retic Menu Options Display Specimen 14:17 Mar 24 2001 Spec ID 222 RETIC DISPLAY SPECIMEN Operator ID Priming Name ________________ 0201 Sequence # Retic Seq #: R63 Pat ID _________ Sex ___ DOB __/__/____ Col __/__/____ --:-- Dr _______________ Cmt _________ Limits 1 RETIC%...
Page 617 Section 14 Reticulocyte Package Previous Specimen The [PREVIOUS SPECIMEN] key is used to display the results for the Reticulocyte Sequence Number preceding the one currently displayed without returning to the RETIC DATA LOG screen. Next Specimen The [NEXT SPECIMEN] key is used to display the results for the Reticulocyte Sequence Number following the one currently displayed without returning to the RETIC DATA LOG screen.
Page 618 Reticulocyte Package Section 14 Retic Menu Options Find Specimen 17:15 Mar 21 2001 RETIC DATA LOG SEARCH Seq # : R Operator ID Ready Spec ID : R0060 Retic Seq# Name : Specimen ID Patient Name Patient ID Limits Date Time Op FILE 2 O02/26/01 14:26 ACS...
Page 619 Section 14 Reticulocyte Package Print Data Log The [PRINT DATA LOG] key is used to print the Reticulocyte Data Log. When the [PRINT DATA LOG] key is pressed, the screen prompts the operator to enter the starting and ending Reticulocyte Sequence Numbers (from the lowest to the highest) for the desired printout.
Page 620 Reticulocyte Package Section 14 Retic Menu Options Data Review from the Retic Data Log Scrolling Through the Retic Data Log The Page Up and Page Down keys on the keyboard can be used to scroll rapidly through the records stored in the Reticulocyte Data Log. Press the Page Up key to scroll backward and press the Page Down key to scroll forward.
Page 621 Section 14 Reticulocyte Package Procedure: Displaying a Record 1. From the RETIC MAIN menu screen press the [RETIC DATA LOG] key. 2. If the desired record is not displayed on the screen, press the [FIND SPECIMEN] key to display the RETIC DATA LOG SEARCH screen. 3.
Page 622 The [RETIC QC] key on the RETIC MAIN menu screen is used to display the RETIC QC LOG screen. The Reticulocyte Package on the CELL-DYN 3200 System offers six QC Logs with statistical and graphical analysis of the data. The statistical analysis includes the mean, standard deviation, and coefficient of variation.
Page 623 Section 14 Reticulocyte Package View QC Log 15:51 Aug 02 2001 Lot Number : PG041-1 VIEW RETIC QC LOG Operator ID Exp. Date: 05/31/01 Ready R0483 Retic Seq# PG041-1: 15/120 Page 2 of 2 Upper Limits: 1.90 Lower Limits: 0.30 Target Mean: 1.10 DATE TIME Op...
Page 624 Reticulocyte Package Section 14 Retic Menu Options 5. The statistics are displayed below the data as follows: The number of runs used in the calculation. The mean value for the number of runs used in the FILE MEAN: calculation. The standard deviation for the number of runs used in the Std Dev: calculation.
Page 625 Section 14 Reticulocyte Package Levey-Jennings 17:16 Mar 21 2001 QC File: FILE 1 RETIC LEVEY-JENNINGS Operator ID Seq num: R7 TO R50 Ready R0060 Retic Seq# WESTGARD RULE WARNINGS PREVIOUS NEXT PRINT RETURN Figure 14.20 The Reticulocyte Levey-Jennings Screen The [LEVEY-JENNINGS] key is used to display the Levey-Jennings graphs of the data in the QC Log.
Page 626 Reticulocyte Package Section 14 Retic Menu Options Reject Specimen/Accept Specimen 14:22 Aug 02 2001 Lot Number: PG041-1 VIEW RETIC QC LOG Operator ID Exp. Date: 05/31/01 Ready R0482 Retic Seq# PG041-1: 15/120 Page 2 of 2 1.90 Upper Limits: Lower Limits: 0.30 1.10 Target Mean:...
Page 627 Section 14 Reticulocyte Package Move Specimen The [MOVE SPECIMEN] key is used to move a QC result located in one file (indicated by the cursor position) to another QC file. When the [MOVE SPECIMEN] key is pressed, the RETIC QC LOG screen is displayed, allowing the desired file to be selected.
Page 628 Reticulocyte Package Section 14 Retic Menu Options 19:19 Feb 23 2001 DIAGNOSTICS MENU Operator ID Ready R0002 Retic Seq# FAULTS EXECUTION RETIC CLEAR RETIC RETIC REPORT TIMES CNT RATE FAULTS RAW DATA MAIN Figure 14.22 Reticulocyte Diagnostics Screen The [RETIC DIAGNOSTIC] key is used to display the DIAGNOSTICS MENU screen. The soft keys displayed on this screen enable the operator or service representative to obtain information that assist in troubleshooting and in identifying the corrective action needed.
Page 629 Section 14 Reticulocyte Package Fault Report When the [FAULTS REPORT] key is pressed, information regarding any pending fault is displayed on the screen. The screen displays the words OPERATOR CORRECTABLE FAULT REPORT: or FATAL FAULT REPORT and any additional information available. If there is no fault, the screen displays the words NO FAULT PENDING.
Page 630 Reticulocyte Package Section 14 Retic Menu Options The data displayed on the screen are the kinetic data for the Reticulocyte specimen from the last run, displayed in a tabular format. (See Figure 14.23.) The total count, data acquisition intervals, and rate per second are displayed. NOTE: Time is displayed on the X-axis.
Page 631 Section 14 Reticulocyte Package Retic Raw Data 19:24 Feb 23 2001 DIAGNOSTICS MENU Operator ID Ready R0002 Retic Seq# List Mode RETIC: 1 RBC: 0 PLT: 0 NOC: 0 LRBC: 0 Raw Count RETIC: 1 RBC/PLT: 0 NOC: 0 HGB Sample 1: 1462 2: 1461 3: 1461...
Page 632 Reticulocyte Package Section 14 Retic Menu Options Retic Special Protocols Menu CD3200 RETIC MAIN MENU SPECIAL PROTOCOLS REAGENT EMPTY/FILL CLEAN/RES DISAB/ENAB RETIC RESERVOIR FLOW CELL SHEAR VALVE ANALYZER MAIN The [RETIC SP PROTOCOLS] key is used to display the SPECIAL PROTOCOLS menu.
Page 633 Section 14 Reticulocyte Package Reagent Reservoir The [REAGENT RESERVOIR] key is used to select the reagent reservoirs for emptying and filling. When the [REAGENT RESERVOIR] key is pressed, the following soft key labels are displayed. RETURN The screen displays instructions for draining and filling the reagent reservoir. EMPTY/FILL DIL/SHEATH When the [EMPTY DIL/SHEATH] key is pressed, the diluent and sheath reservoirs are drained and the key toggles to [FILL DIL/SHEATH].
Page 634 Reticulocyte Package Section 14 Retic Menu Options Disable/Enable Analyzer When the [DISAB/ENAB ANALYZER] key is pressed, a submenu is displayed showing the [DISABLE ANALYZER] and [RETURN] keys. The [DISABLE ANALYZER] key is used to prevent the Analyzer from cycling while certain maintenance procedures are performed.
Page 635 Routine Operation Overview This section contains information and procedures that are recommended for the routine operation of the Reticulocyte Package for the CELL-DYN 3200 System. This section contains the following subsections: • Retic Specimen Type Flowchart • RETIC SPECIMEN TYPE Menu •...
Page 636 Reticulocyte Package Section 14 Routine Operation Retic Specimen Type Flowchart CD3200 RETIC MAIN MENU RETIC RETIC RETIC RETIC RETIC SP RETIC DATALOG DATA LOG DIAGNOSTIC PROTOCOLS SET UP RETIC SPECIMEN TYPE PATIENT BACK- RETIC MAIN SPECIMEN SPECIMEN GROUND RETIC PATIENT SPECIMEN RETIC RUN RESULT RETIC RUN RESULT ENTER SPECIMEN ID DATA...
Page 637 Section 14 Reticulocyte Package Retic Specimen Type Menu 19:31 Feb 23 2001 RETIC SPECIMEN TYPE Operator ID Ready R0002 Retic Seq# File Name # Specimens FILE 1 FILE 2 FILE 3 FILE 4 FILE 5 FILE 6 Press QC SPECIMEN softkey to select QC FILE at cursor position. PATIENT BACK- RETIC...
Page 638 Reticulocyte Package Section 14 Routine Operation NOTE: A message describing the fault is displayed on the bulletin line. A list of fault conditions and corrective action is given in Section 10: Troubleshooting and Diagnostics. Patient Specimen The [PATIENT SPECIMEN] key on the RETIC SPECIMEN TYPE screen is used to display the first RETIC PATIENT SPECIMEN screen.
Page 639 Section 14 Reticulocyte Package • If a Y is entered, the RETIC RUN RESULT screen will display the patient demographic information and RBC value. NOTE: If no RBC value is displayed (if there is a blank space following RBC), the RBC value was suppressed due to an RBC metering fault.
Page 640 Reticulocyte Package Section 14 Routine Operation 16:29 Aug 03 2001 RETIC SPECIMEN TYPE Operator ID Ready R0484 Retic Seq# ENTER SPECIMEN ID: d17484 Press ENTER to confirm. SPECIMEN ID: D17484 was found in HEMATOLOGY DATA LOG but specimen data are more than 8 hours old . . . Enter RBC value - - - - - - - M/uL.
Page 641 Section 14 Reticulocyte Package If the Specimen ID is not found in the Standard Hematology Data Log, the fourth RETIC PATIENT SPECIMEN screen is displayed. (See the following figure.) This screen displays a place for the operator to enter the RBC value. If an entry error is made in the fourth RETIC PATIENT SPECIMEN screen, the operator may press the [CANCEL] key to return to the RETIC SPECIMEN TYPE screen.
Page 642 Reticulocyte Package Section 14 Routine Operation Retic Run Result Screen 13:47 Aug 02 2001 Spec ID D17516 RETIC RUN RESULT Operator ID Ready Name ________________ R0481 Retic Seq# Pat ID _________ Sex ___ DOB __/__/____ Col __/__/____ --:-- Dr _______________ Cmt _________ Limits 1 RETIC% 1.63...
Page 643 Section 14 Reticulocyte Package 4. <Sex (M/F)> This data entry field automatically displays the sex and 5. <DOB> birthdate of the patient if it was found in the Standard Hematology Data Log. If the information was not found in the Standard Hematology Data Log, the sex and birth date of the patient can be entered here.
Page 644 Reticulocyte Package Section 14 Routine Operation Upper Right Corner The upper right-hand corner of the RETIC RUN RESULT screen displays the following information: • The current date and time. • The Operator ID (which identifies the current operator). • The Reticulocyte Sequence Number. ("R _ _ _ _ ," which automatically increments as reticulocyte samples are run.) Center The center section of the RETIC RUN RESULT screen displays the results.
Page 645 Section 14 Reticulocyte Package QC Specimen 19:58 Feb 23 2001 Lot Number: 65185 RETIC RUN RESULT Operator ID Ready File: SCORTE 0/120 R0003 Retic Seq# RETIC % CANCEL Figure 14.33 Reticulocyte Run Result Screen for a QC Specimen When the [QC SPECIMEN] key on the RETIC SPECIMEN TYPE screen is pressed, the QC file where the cursor is positioned is opened and the RETIC RUN RESULT screen for QC specimens is displayed.
Page 646 Reticulocyte Package Section 14 Routine Operation Background 19:58 Feb 23 2001 Type: BACKGROUND RETIC RUN RESULT Operator ID Ready R0003 Retic Seq# Background Count found in Retic area For Retic Backgroound, run the Retic Reagent. CANCEL Figure 14.34 Reticulocyte Run Result Screen for a Background Specimen When the [BACKGROUND] key on the RETIC SPECIMEN TYPE screen is pressed, the RETIC RUN RESULT screen for background counts is displayed.
Page 647 EDTA or NA EDTA is the specimen of choice for Reticulocyte analysis on the CELL-DYN 3200 System. Specimens may be run up to 8 hours after collection time when stored at room temperature. NOTE: Studies have shown that reticulocytes continue to mature at room temperature.
Page 648 If the RBC value is not entered, only the % Reticulocyte value will be obtained. Interfering Substances The CELL-DYN 3200 Reticulocyte method is a nucleic acid staining method. Therefore, other substances that contain nucleic acids could potentially be enumerated by the instrument as reticulocytes. If these interfering substances are present in sufficient numbers, they may interfere with the dynamic thresholds used to obtain the CELL-DYN 3200 reticulocyte count.
Page 649 Section 14 Reticulocyte Package Procedure: Background Count 1. Select a tube from the current lot of reticulocyte reagent that will be used for the day’s testing. 2. Label the tube “Retic Background” and record the current date on the tube. NOTE: One tube may be used to check daily background counts for a one- week period, provided the reagent is not contaminated.
Page 650 NOTE: The stained control specimens may incubate for up to 30 minutes prior to processing on the CELL-DYN 3200 System. 6. Verify that the Reticulocyte Package is turned ON. For instructions on turning ON the Reticulocyte Package, refer to Retic Menu Options, Turning the Reticulocyte Package ON and OFF within this chapter.
Page 651 NOTE: The stained Reticulocyte specimens must incubate for 15 minutes but no more than 2 hours prior to processing on the CELL-DYN 3200 System. This timing will allow the Reticulocyte specimens to be processed for STAT requests. Reticulocyte specimens can also be grouped and run in batches, provided that the 2-hour incubation time limit is not exceeded.
Page 652 Reticulocyte Package Section 14 Routine Operation 3. If the Specimen ID is found, the second RETIC PATIENT SPECIMEN screen is displayed. All the available patient demographic information, and the RBC value, are shown on the screen. Proceed to step 4. If the Specimen ID is found but is more than 8 hours old, the third RETIC PATIENT SPECIMEN screen is displayed and the operator may enter an RBC value in this screen.
Page 653 Section 14 Reticulocyte Package Quality Control Guide The CELL-DYN 3200 System offers several quality control options to monitor and validate instrument performance while running the Reticulocyte Package. The options are: • 6 QC Files Statistical and graphical analysis of the data in each...
Page 654 Reticulocyte Package Section 14 Quality Control Guide Quality Control Specimens Always mix and handle commercial control material according to the directions given in the package insert. Pay particular attention to the following: • Store the CELL-DYN Retic-RITE™ controls in the refrigerator at 2°– 8° C. Store in a suitable location in the refrigerator, away from the door if it is opened frequently.
Page 655 Reticulocyte Package. All instrument conditions which adversely affect the Standard Hematology Mode of the CELL-DYN 3200 System will also apply to the Reticulocyte Package. These instrument conditions may be found in Section 10: Troubleshooting and Diagnostics.
Page 656 Reticulocyte Package Section 14 Troubleshooting Operational Messages and Data Flagging Dispersional Data Alerts The result of each run (patient, control, or background) is reviewed within the appropriate limits as entered by the operator or taken from the instrument’s preset limits. If a result for a parameter exceeds these limits, they are flagged on the screen and on the report.
Page 657 Section 14 Reticulocyte Package Data Invalidating Alerts The Reticulocyte results are not suppressed for the Data Invalidating Alerts. The alert message appears in the lower left-hand quadrant of the Display Monitor screen and on the graphics printout under the heading ALERTS. Table 14.3 Data Invalidating Alerts Alert...
Page 658 Reticulocyte Package Section 14 References References 1. National Committee for Clinical Laboratory Standards. Methods for Reticulocyte Counting (Flow Cytometry and Supravital Dyes); Approved Standard. NCCLS document H44-A (ISBN 1-56238-302-7). NCCLS, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087, 1997. 2.
Page 659 • The computer and appropriate software interprets and stores bar code data. For the CELL-DYN 3200 System, this is accomplished by the Data Station and its software. • The scanning device "decodes" the information on the bar code labels. The Tower Module on the CELL-DYN 3200 System incorporates an integral bar code reader, allowing the use of bar codes on both the SL and CS models.
Page 660 Bar Codes Appendix A Overview Understanding the Label’s Code In all bar code symbologies, the code consists of elements (single bars or white spaces) and characters (groups of elements that stand for numbers or letters). In code 39, a commonly used symbology, each code character contains nine elements, at least three of which must be wide.
Page 661 Appendix A Bar Codes Bar Code Types and Characteristics The CELL-DYN 3200 System reads four types of bar code labels: • Code 39 • Code 128 • Interleaved 2 of 5 • Codabar Code 39 Also referred to as code 3 of 9, Code 39 encodes 43 data characters: 0-9, A-Z, six symbols, and spaces.
Page 662 Bar Codes Appendix A Overview NOTES CELL-DYN ® 3200 System Operator’s Manual 9140181H—October 2001...
Page 663 Specifications Bar Code Label Formats The Bar Code Reader on the CELL-DYN 3200 System can read all four label types listed below. Code size, collection tube length, and cap style limit the number of digits to the following maximum numbers: A minimum of three digits is required.
Page 664 Bar Codes Appendix A Specifications Bar Code Label Specifications Bar code labels must be printed on good quality label stock and must meet the following specifications: • 0.25 inch minimum quiet zone on each end • 0.01 inch (10 mils) minimum narrow bar width •...
Page 665 Appendix A Bar Codes Figure A.1 Bar Code Placement Guide CELL-DYN ® 3200 System Operator’s Manual 9140181H—October 2001...
Page 666 Bar Codes Appendix A Specifications NOTES CELL-DYN ® 3200 System Operator’s Manual 9140181H—October 2001...
Page 667 Appendix A Bar Codes Bar Code Operation The system can take a number of actions depending on the Bar Code Set Up configuration and the symbology of the label. A brief description of each possible action is given below. Code 39 If the Instrument is configured for Code 39 with Check Digit ON, the Instrument will: a.
Page 668 Bar Codes Appendix A Bar Code Operation If the Instrument is configured for Code 39 with Check Digit OFF, the Instrument will: a. read all four bar code symbologies’ labels with a check digit. The bar code reader reads the entire number including the check digit and the Work List is searched.
Page 669 Appendix A Bar Codes I2of5 If the Instrument is configured for I2of5 with Check Digit ON, the Instrument will: a. read an I2of5 label with check digit. If the check digit on the label matches the check digit calculated by the Instrument, the “read”...
Page 670 Bar Codes Appendix A Bar Code Operation Codabar If the Instrument is configured for Codabar with Check Digit ON, the Instrument will: a. read a Codabar label with check digit. If the check digit on the label matches the check digit calculated by the Instrument, the “read”...
Page 671 Appendix A Bar Codes Code 128 If the Instrument is configured for Code 128, the check digit feature is automatically ON and the Instrument will: a. read a Code 128 label. If the check digit on the label matches the check digit calculated by the Instrument, the “read”...
Page 672 Bar Codes Appendix A Acknowledgment Acknowledgment The authors wish to acknowledge Computype, Inc. of St. Paul, Minnesota, for providing their booklet "Bar Coding and Productivity" to assist in the writing of this Appendix. A-14 CELL-DYN ® 3200 System Operator’s Manual 9140181H—October 2001...
Page 673 Overview This section gives a lists the part numbers of components, accessories, controls, reagents, and consumables associated with the CELL-DYN 3200 System for user convenience when placing orders. To place an order for these products, dial our toll-free Customer Service Network at 1 (800) 323-9100.
Page 674 Parts List Appendix B Overview Table B.2 CELL-DYN 3200 Sample Loader Accessories Kit List Number Quantity Name Comments 04H87-01 1 set Racks, Sample Loader Set of 5 Sample Loader racks pre- labeled with tube position numbers and rack number label CELL-DYN 3200 Optional Accessories Table B.3...
Page 675 Appendix B Parts List Table B.3 CELL-DYN 3200 Optional Accessories (Continued) Part/List Quantity Name Description Number 28561-01 Syringe, 2.5 mL For dispensing WBC Lyse or HGB Lyse reagent 28560-01 Syringe, 500 µL For injecting diluted sample into optical flow cell...
Page 676 1/case 03H40-01 Reagent, Reticulocyte 5.0 mL tubes, each tube Kit of 100 containing 3.7 mL of reagent Table B.6 CELL-DYN 3200 Reagent Inlet/Outlet Tubing (List Number 06H65-01) List Number Quantity Name Comments *8921205901 Tubing, Reagent, Diluent/Sheath Includes reagent container cap,...
Page 677 Index Index Abbott representative 10-10, 10-11 Background 4-9 ACCEPT SPECIMEN 14-38 Background Counts 1-26, 4-9, 5-74, 6-10, Accessory Kit 2-2 9-14, 9-15, 9-16, 9-24, 9-33, 9-35, 9-38, Accuracy 4-13 9-45, 9-47, 9-49, 9-52, 9-54, 10-26 Aerosol Filter 1-12 Background Counts...
Page 678 Index Calibration frequency 6-4 Calibration guidelines 6-7 Daily Shutdown 9-7 Calibration Log 6-16 Daily Shutdown cycle 5-99 Calibration Logbook 6-5 Daily Shutdown Procedure 5-99 Calibration logbook 6-5 Data Flagging 14-68 Calibration Materials 5-93, 6-5 Data Invalidating Alerts 14-69 Calibration Menu 6-13, 6-15 Data Log 5-65, 5-72, 5-73, 5-74, 5-103, Calibration overview 6-1 5-109, 5-115, 5-120, 5-125, 5-127, 5-130,...
Page 679 Index Diluent Reservoirs 1-12 Faults Conditions 1-9, 5-67, 5-69, 5-97, 10-1, Diluent/Sheath 1-26 10-31 Diluent/Sheath Inlet Tube 1-17 Faults Tables 10-1, 10-31 Diluent/Sheath Syringe 1-11 FILE MEAN 14-36 dilution ratios 3-3, 3-4 Flagging Messages 3-27 Disable analyzer 9-5, 9-6, 9-20, 9-34, 9-36, Flags 4-16, 5-77, 5-110, 10-28 9-40, 9-46, 9-47, 9-50 Flags - Suspect Parameter 3-30...
Page 680 Index Maintenance - nonscheduled 9-29 Maintenance Log 10-25 Imprecise or Inaccurate Data - Maintenance Procedures - daily 9-13 troubleshooting 10-27 Maintenance Procedures - monthly 9-21 Incomplete Aspiration 5-98, 10-27 Maintenance Procedures - semiannual 9-27 Incomplete aspiration 5-137 Maintenance Procedures - weekly 9-19 incubate 14-63 Maintenance Schedule 9-10 incubation time limit 14-63...
Page 681 Index Open Sampler aspiration 5-94 pressure pump test 10-12 Operating Environment 4-5 Pressure Test 10-14, 10-17 OPERATION SET UP MENU 14-8 Preventive Maintenance 9-9 Operational Messages 14-68 Printed Circuit Boards 1-21 Operator correctable fault 10-6, 10-23 Printer 5-59 operator correctable faults 10-8 Printer Cleaning 9-27 Operator ID 5-66, 5-85, 6-16 Printer connector 12-5...
Page 682 Index RETIC PT LIMITS 14-15 Retic QC Limit 14-18 Rack Movement - Sample Loader 13-14 RETIC QC SET UP 14-17 Rack starting position - Sample Loader 13-14 Retic Run Menu 14-6 RANGE ENTRY 14-18 Retic Run Menu Flowchart 14-4 Range Entry 14-19 RETIC RUN RESULT screen 14-53, 14-54 Raw data summary 10-9, 10-28 RETIC RUN screen 14-49, 14-59...
Page 683 Index Sample Loader Dimensions 13-3 Special Protocols Sample Loader End rack 5-89 Flowchart 5-12 Sample Loader fault 13-12 Specimen ID 14-50 Sample Loader faults 13-12, 13-13 Specimen Preparation 14-63 Sample Loader Installation 2-15 Specimen Requirements 14-59 Sample Loader Mixing Assembly 13-6 Spinner Assembly 1-12 Sample Loader Operations 13-19 Standard Groups 5-134...
Page 684 Index troubleshooting guide 10-23 Troubleshooting Imprecise or Inaccurate Warranty ii Data 10-27 Wash Block 1-11 Troubleshooting procedures 10-25 Waste 1-12, 1-17 Tube Dimensions 4-6 Waste Container 6-10 Tube Racks set up 2-16 Waste Containers 1-17 Tube Retainer 5-96 Waste Outlet Tube 1-17 Tube Retainer adjustment 1-25 Waste Sensor 1-17, 2-6 Tube Sensor Assembly 1-24...

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