Page 1 • Operating Instructions • Calibration • Quality Control • Precautions, Limitations and Hazards • Maintenance • Troubleshooting • Printer • Sample Loader • Bar Codes ENTIRE CONTENTS COPYRIGHT ABBOTT LABORATORIES ABBOTT LABORATORIES 1993 ABBOTT PARK, IL 60064 U.S.A. PRINTED IN THE U.S.A.
Page 2: Table Of Contents
Proprietary Information ........2 Abbott Instrument Warranty .......3 Text Conventions .
Page 3 Search Book TOC Go Back Sample Loader ........2-8 Installation .
Page 4 Search Book TOC Go Back Parameter Flagging Messages ......3-27 Dispersional Data Alerts ......3-28 Suspect Parameter Flags .
Page 5 Search Book TOC Go Back Chapter 5. Operating Instructions Introduction ......... .5-1 Data Station Program Overview .
Page 6 Search Book TOC Go Back Sample Analysis on the CELL-DYN 3000CS ....5-80 Running Samples ......5-81 Daily Shutdown .
Page 7 Search Book TOC Go Back Manual Calibration Overview ......6-24 Introduction ........6-24 Guidelines .
Page 8 Search Book TOC Go Back Closed Mode Procedures ........6-59 Mode To Mode Auto-Cal, Sampler Loader Procedure .
Page 9 Westgard Rules ........7-15 CELL-DYN 3000 Westgard Rules ....7-15 X-B Analysis .
Page 10 Search Book TOC Go Back Daily ..........9-13 Daily Maintenance Procedures .
Page 11 Search Book TOC Go Back Troubleshooting Tips and Techniques ....10-38 Introduction ........10-38 Troubleshooting the Background Count .
Page 12 Bar Code Types and Characteristics ....A-2 CELL-DYN 3000 Bar Code Specifications ....A-3 Bar Code Label Specifications .
Page 13 Search Book TOC Go Back NOTES Master Table of Contents - 12 CELL-DYN® 3000 System Operator’s Manual 9140240E — May 1995...
Page 14 CELL-DYN 3000CS ......1-2 Figure 1.3: CELL-DYN 3000 System Components ... 1-5 Figure 1.4: CELL-DYN 3000 Analyzer Front View .
Page 15 Search Book TOC Go Back Figure 5.7: X-B Setup Screen ......5-13 Figure 5.8: QC Range Entry Screen ..... .5-17 Figure 5.9: QC Means/Limits Entry Screen .
Page 16 Calibration Log Screen ..... . . 6-17 Figure 6.5: Auto-Calibration Screen for CELL-DYN 3000 ..6-17 Figure 6.6: Whole Blood Auto-Cal Screen .
Page 17 Search Book TOC Go Back Figure 9.11: Data Station Rear Panel ..... .9-31 Figure 9.12: Special Protocols: Extended Auto-Clean Screen . . .9-33 Figure 9.13: Transducer Assembly —...
Page 18 Search Book TOC Go Back Figure 12.4: Sample Loader ......12-4 Figure 12.5: Operation Keyboard .
Page 19 Search Book TOC Go Back NOTES Master Table of Contents - 18 CELL-DYN® 3000 System Operator’s Manual 9140240E — May 1995...
Page 20 Search Book TOC Go Back List of Tables Table 3.1: Parameter Flagging Messages ....3-27 Table 3.2: Interpretive Messages ......3-34 Table 4.1: Dimensions —...
Page 21 Search Book TOC Go Back NOTES Master Table of Contents - 20 CELL-DYN® 3000 System Operator’s Manual 9140240E — May 1995...
Page 22: Introduction
For your continuing service, we also provide telephone technical assistance, should you need additional information or assistance in diagnosing a problem. This service is available by calling the Abbott Customer Support Center at 1 (800) CELL DYN or 1 (800) 235-5396.
Page 23: Proprietary Information
The CELL-DYN 3000 instrument system is covered by one or more of the following U. S. Patents: 4,710,021; 4,726,237; 5,017,497; and 5,378,633.
Page 24: Abbott Instrument Warranty
CELL-DYN 3000 Series Customers. 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 3.
Page 25 The CELL-DYN 3000 Series Hematology Systems are manufactured by Abbott Diagnostics, a wholly owned subsidiary of Abbott Laboratories, Abbott Park, IL 60064, U.S.A. Please direct all inquiries concerning information in this manual to the foregoing address. Direct all inquiries regarding equipment...
Page 26: Text Conventions
Search Book TOC Go Back Text Conventions The following text conventions are used in this manual: INFORMATION PRESENTATION Note, Important INDENTED, ALL CAPITALS, BOLD ALL CAPITALS, UNIVERSAL BOLD Screen or Menu display Data entry field <Within Brackets, Universal Bold, Text matches screen> Universal Bold, Text matches screen Bulletin Message Status Condition...
Page 27: Safety Icon Conventions
Search Book TOC Go Back Safety Icon Conventions This icon is used in major hazard situations where an DANGER: immediate hazard presents a threat of serious injury. This icon represents the highest level of any hazardous situation. Represents a hazard level between caution and WARNING: danger.
Page 28: Revision Status
9211420A Original Issue Not Applicable 9211420B Section 1-8: Heading added "1-8 Red Cell Parameters" Figures renumbered in Table of Contents 92420-01C Name change from Unipath to Abbott and changed PN 9211420 to List No. 92420-01 9140240D 6/93 All pages 9140240E 5/95 All pages CELL-DYN®...
Page 29 Search Book TOC Go Back Manual Revision Log on the next page is provided to document revisions to this manual. The user should record the appropriate information and sign and date this log to provide a permanent record. CELL-DYN® 3000 System Operator’s Manual 9140240E —...
Page 30: Manual Revision Log
Search Book TOC Go Back Manual Revision Log Revision* Date Incorporated Revision Incorporated By ____________________ ____________________ ________________________________________ ____________________ ____________________ ________________________________________ ____________________ ____________________ ________________________________________ ____________________ ____________________ ________________________________________ ____________________ ____________________ ________________________________________ ____________________ ____________________ ________________________________________ ____________________ ____________________ ________________________________________ ____________________ ____________________ ________________________________________ ____________________ ____________________ ________________________________________ ____________________ ____________________ ________________________________________ ____________________ ____________________ ________________________________________ ____________________ ____________________ ________________________________________...
Page 31 Search Book TOC Go Back NOTES CELL-DYN® 3000 System Operator’s Manual 9140240E — May 1995...
Page 32: Chapter 1. System Description
Chapter 1 Search Book TOC Go Back System Description Chapter Table of Contents Introduction ..........1-1 Intended Use.
Page 33 Chapter 1 Table of Contents Search Book TOC Go Back Rear Panel ......... .1-15 Fans.
Page 34: Introduction
Chapter 1 Search Book TOC Go Back System Description Introduction The CELL-DYN® 3000 is a multi-parameter, automated hematology analyzer designed for in vitro diagnostic use in clinical laboratories. The instrument has two versions, the automated Sample Loader or manual closed sampler.
Page 35: Figure 1.2: Cell-Dyn 3000Cs
System Description Chapter 1 Search Book TOC Go Back Analyzer Data Station Figure 1.2: CELL-DYN 3000CS The CELL-DYN 3000CS is equipped with a built-in manual closed sample aspiration module referred to as the closed sampler. The closed sampler aspirates blood from a closed collection tube that has been inserted in the sampler module.
Page 36: Intended Use
System Description Search Book TOC Go Back Intended Use The CELL-DYN 3000 generates the following hematologic measurements on EDTA anticoagulated whole blood: WBC — White Blood Cell or Leukocyte count NEU — Neutrophil absolute count %N — Neutrophil percent LYM — Lymphocyte absolute count %L —...
Page 37 System Description Chapter 1 Search Book TOC Go Back NOTES CELL-DYN® 3000 System Operator’s Manual 9140240E — May 1995...
Page 38: System Components
Go Back System Components Analyzer Data Station Figure 1.3: CELL-DYN 3000 System Components The two main modules of the CELL-DYN 3000 are depicted in Figure 1.3. Analyzer The Analyzer contains the hardware to aspirate, dilute and analyze each whole blood specimen.
Page 39: Analyzer Components
Closed Sample Lower Front Cover Aspiration Module Figure 1.4: CELL-DYN 3000 Analyzer Front View Upper Front Cover The removable upper front cover protects the upper flow panel. It contains a window that allows the operator to view the shear valve. The cover is removed by lifting it up and away from the mounting brackets.
Page 40 Chapter 1 System Description Search Book TOC Go Back Lower Front Cover The removable lower front cover protects the lower flow panel. To remove the cover, first remove the upper front cover then disconnect the grounding wire from the clip mounted to the flow panel and lift up on the cover to free it from the mounting brackets.
Page 41: Flow Panel
System Description Chapter 1 Search Book TOC Go Back • The quick adjust levers which are located on either side of the tube retainer. The levers are used to raise or lower the tube retainer in order to securely hold the collection tube in the proper position •...
Page 42 Chapter 1 System Description Search Book TOC Go Back • HGB Diluent syringe — delivers a specific volume of Diluent to transport the blood from the shear valve to the HGB mixing chamber • HGB Lyse syringe — dispenses a specific volume of Hemoglobin Lyse into the HGB Mixing chamber at the same time as the diluted sample is dispensed into the HGB Mixing chamber •...
Page 43: Figure 1.5: Analyzer Flow Panel Components
System Description Chapter 1 Search Book TOC Go Back Figure 1.5: Analyzer Flow Panel Components 1-10 CELL-DYN® 3000 System Operator’s Manual 9140240E — May 1995...
Page 44 Chapter 1 System Description Search Book TOC Go Back RBC/PLT Metering Assembly The RBC/PLT metering assembly contains a precision-bore glass tube with a set of optical detectors, one upper and one lower, mounted on it. It is used to meter a fixed volume of the RBC/PLT dilution to ensure that an accurate volume is counted during the RBC/PLT measurement portion of each cycle.
Page 45: Left Side Panel
System Description Chapter 1 Search Book TOC Go Back Overflow Chamber The overflow chamber is used to collect excess fluid from the mixing chambers. WBC Mixing Chamber The glass WBC mixing chamber is used to mix the WBC dilution. HGB Mixing Chamber The glass HGB mixing chamber is used to mix the HGB dilution.
Page 46: Figure 1.6: Analyzer Left Side Panel Components
Chapter 1 System Description Search Book TOC Go Back Pinch Valves Analyzer Air Inlet Power Switch Filter Auto Sampler Connector Diluent Reservoir Waste Sensor Sheath Connector Reservoir HGB Lyse Inlet Tube Hemoglobin Connector Lyse Reservoir Diluent Inlet Tube Connector Air Inlet Filter Sheath Inlet Tube...
Page 47 System Description Chapter 1 Search Book TOC Go Back Sheath Reservoir The Sheath reservoir maintains the Sheath reagent supply within the Analyzer. Hemoglobin Lyse Reservoir The Hemoglobin Lyse reservoir maintains the Hemoglobin Lyse supply within the Analyzer. Normally Closed Valves The three normally closed valves prevent the reagents in the reservoirs from draining down into the Analyzer when the Analyzer power is turned OFF.
Page 48: Rear Panel
Chapter 1 System Description Search Book TOC Go Back Hemoglobin Lyse Inlet Tube Connector This color-coded (blue) port is used to connect the Hemoglobin Lyse inlet tube with its associated cap, sinker and label. Waste Outlet Tube Connector This color-coded (black) port is used to connect the waste outlet tube. Rear Panel The components visible on the rear panel of the Analyzer are depicted in Figure 1.7.
Page 49 Analyzer Power Connector This receptacle is used to connect the main power cord to the Analyzer. RS-232 Connector This port is used by Abbott personnel. Data Station Connector This connector is used to attach the cable that provides communication between the Data Station and the Analyzer.
Page 50: Data Station
Data Station Overview The Data Station contains the video display monitor, computer and keyboards. The CELL-DYN 3000 operations are controlled by high-speed microprocessors that monitor system status, perform the various analytical routines used by the instrument, perform diagnostic checks and store result data.
Page 51: Front Panel
System Description Chapter 1 Search Book TOC Go Back Front Panel Video Display Screen A 14-inch diagonal, high-resolution video display screen with 16-color illumination displays all alphanumeric and graphic data. Soft Keys A row of eight unlabeled pressure-sensitive soft keys is located directly below the screen.
Page 52: Right Side Panel
Chapter 1 System Description Search Book TOC Go Back Standard Computer Keyboard The standard computer keyboard connects to the rear panel of the Data Station and contains a complete set of alphabetic, numeric and special function keys used for data entry and manipulation. The F1 to F8 function keys on this keyboard correspond to the soft keys on the Data Station.
Page 53: Rear Panel
System Description Chapter 1 Search Book TOC Go Back Contrast Control This control adjusts the contrast of the video display screen. Brightness Control This control adjusts the brightness of the video display screen. Power Switch This is the main power switch for the Data Station. Rear Panel components located on the rear panel of the Data Station depicted in...
Page 54 Chapter 1 System Description Search Book TOC Go Back The fan cools the Data Station. Monitor Video Cable The monitor video cable provides video input to the monitor. It connects to the monitor video connector. External Computer Port The External Computer Port is used to interface the Data Station to a Laboratory Information System (LIS).
Page 55: Printer
Use of reagents other than those specified in this manual is not recommended as instrument performance can be affected. Each CELL-DYN 3000 system is tested at the factory using the specified reagents and all performance claims were generated using these reagents.
Page 56: Cell-Dyn Reagents
Chapter 1 System Description Search Book TOC Go Back CELL-DYN Reagents Diluent (L/N 99231-01) CELL-DYN Diluent is formulated to: • Dilute the RBCs, PLTs and Hemoglobin • Maintain the stable diluted cell volume of each red cell and platelet during the count and sizing portion of the measurement cycle •...
Page 57 System Description Chapter 1 Search Book TOC Go Back NOTES 1-24 CELL-DYN® 3000 System Operator’s Manual 9140240E — May 1995...
Page 58: Chapter 2. Installation
Chapter 2 Search Book TOC Go Back Installation Chapter Table of Contents Introduction ..........2-1 Initial Preparation .
Page 59 Chapter 2 Table of Contents Search Book TOC Go Back NOTES Table of Contents-2 CELL-DYN® 3000 System Operator’s Manual 9140240E — May 1995...
Page 60: Introduction
Installation Introduction Installation of the CELL-DYN® 3000 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 and may void the warranty.
Page 61: Initial Preparation
The instrument is shipped from the factory as follows: CELL-DYN 3000SL • Analyzer • Data Station • Sample Loader with accessories • CELL-DYN 3000 Accessory Kit • Printer • Reagents, Calibrator, and Controls necessary for installation CELL-DYN 3000CS • Analyzer •...
Page 62: Waste Requirements
Chapter 2 Installation Search Book TOC Go Back • The location should have nonporous, non-absorbing work surfaces and flooring which can be easily cleaned and disinfected using recommended procedures. Waste Requirements Allow room for a suitable waste container or position the instrument to permit the waste to be routed directly to a drain.
Page 63: Graphics Printer
Search Book TOC Go Back When interfaced with the CELL-DYN 3000, the printer can be configured as either a graphics printer for graphic reports or a ticket printer for blank or pre-printed tickets. The same model printer can be used for either configuration, but if both tickets and graphics reports are required two printers must be installed.
Page 64: Ticket Printer
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 Customer Support Center for assistance at 1 (800) CELL DYN or 1 (800) 235-5396 (U.S. customers only).
Page 65: Figure 2.1: Data Station Rear Panel
Installation Chapter 2 Search Book TOC Go Back Graphics Printer Port Ticket Printer Port Figure 2.1: Data Station Rear Panel 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 back of the printer and plug the other end into a grounded outlet.
Page 66 Chapter 2 Installation Search Book TOC Go Back Loading Individual Tickets in the Ticket Printer 1. Be sure that the printer is turned ON and the printer cable is connected to the ticket printer port on the back of the Data Station. If the connection is incorrect, turn the Data Station power OFF, change the position of the cable and turn the power back ON.
Page 67: Sample Loader
Installation Chapter 2 Search Book TOC Go Back Sample Loader Installation A metal pedestal is shipped with the CELL-DYN 3000SL. This pedestal has an attached platform for the Sample Loader. The pedestal is placed under the Analyzer and the Sample Loader is set on the platform. Data Station Analyzer Sample Loader...
Page 68: Fluid Tubing Connection
Chapter 2 Installation Search Book TOC Go Back 3. Remove the power cord from the sample loader accessory kit and inspect the cord and connector for damage. Connect the cord to the power connector on the right side panel. Plug the three- prong end into an available power outlet.
Page 69: Tube Racks Setup
Installation Chapter 2 Search Book TOC Go Back 2. Connect the red tube (aspiration waste fluid) connector to the red tube attached to the lower port of the aspiration needle wash block. Figure 2.3. 3. Connect the clear tube (aspiration rinse fluid) connector to the clear tube attached to the upper port of the aspiration needle wash block.
Page 70: Power On
Chapter 2 Installation Search Book TOC Go Back 5. Place five racks in the open area to the left of the tower and five racks in the open area to the right of the tower. Push all of the right side racks toward the Analyzer.
Page 71 Installation Chapter 2 Search Book TOC Go Back 2. Test Sample Loader operation by running several blood samples. If necessary, refer to the directions given in the Routine Operation section of Chapter 5, Operating Instructions. 3. Confirm that the background count is acceptable before running patient samples.
Page 72: Chapter 3. Principles Of Operation
Chapter 3 Search Book TOC Go Back Principles of Operation Chapter Table of Contents Overview ..........3-1 Sample Aspiration .
Page 73 Chapter 3 Table of Contents Search Book TOC Go Back PLT Measurement ........3-22 Platelet Parameters .
Page 74: Overview
The three independent measurement channels used in the CELL-DYN 3000 are: • The optical channel for determining the WBC count and differential data •...
Page 75: Sample Aspiration
Principles of Operation Chapter 3 Search Book TOC Go Back Sample Aspiration There are two modes of whole blood sample aspiration on the CELL- DYN 3000. The operator selects the mode of aspiration from the Data Station 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 76: Rbc/Plt Analysis
Chapter 3 Principles of Operation Search Book TOC Go Back 2. The sample segment and sheath are then routed to the WBC mixing chamber where the dilution is bubble mixed. The final dilution is 1:51. 3. The action of the WBC peristaltic pump transfers the WBC dilution from the WBC mixing chamber to the sample feed nozzle in the WBC flow cell.
Page 77: Instrument Rinsed
Principles of Operation Chapter 3 Search Book TOC Go Back Instrument Rinsed 1. The open sample aspiration probe is rinsed internally and externally with Diluent. 2. The needle used in either closed mode is rinsed internally and externally with Diluent. 3.
Page 78: Wbc Measurement
Chapter 3 Principles of Operation Search Book TOC Go Back WBC Measurement Overview This section gives an overview of the WBC measurement. The details are discussed in the sections covering the optical bench and the differential. The optical channel is used for the determination of WBC data. A 1:51 dilution of the sample is made with the Sheath reagent.
Page 79: Introduction To Flow Cytometry
Search Book TOC Go Back Introduction to Flow Cytometry The CELL-DYN 3000 uses flow cytometric techniques to analyze the WBC subpopulations. This section gives a brief introduction to the principles of flow cytometry. “Flow cytometry is a process in which individual cells or other biological...
Page 80: Figure 3.1: Wbc Flow Cell
Combining the information from the two scatter measurements provides more accurate discrimination between cell populations than either single measurement. (See Figure 3.2 for an example of the light scatter measured by the CELL-DYN 3000.) CELL-DYN® 3000 System Operator’s Manual 9140240E — May 1995...
Page 81: Sheath Reagent
Principles of Operation Chapter 3 Search Book TOC Go Back Various Angles Focused of Scattered Light Laser Beam ° Scatter ° Scatter ° D Scatter ° Scatter Figure 3.2: WBC Light Scatter Sheath Reagent The Sheath reagent is an integral part of the WBC analysis. White blood cells diluted in the Sheath reagent maintain cellular integrity close to their native state.
Page 82: Figure 3.3: Optical Bench
Chapter 3 Principles of Operation Search Book TOC Go Back The light source is a vertically polarized 5 mW helium-neon laser with a wavelength of 632.8 nm. The laser beam passes through a cylindrical lens which changes the shape from a circle to an ellipse. The beam is then directed through a 125 µm slit which blocks the weaker outer edges.
Page 83: Wbc Differential
Principles of Operation Chapter 3 Search Book TOC Go Back The orthogonal scatter is directed through a 700 µm slit which blocks the scatter from the walls of the flow cell. A beam splitter then separates the orthogonal light scatter into two portions. One portion of the light is directed to the 90 °...
Page 84: Figure 3.4: Mononuclear-Polymorphonuclear Scatter
Chapter 3 Principles of Operation Search Book TOC Go Back Two populations of cells are clearly seen on the display. The mononuclear cells fall in the cluster in the lower left corner of the scatterplot and the polymorphonuclear cells fall in the cluster above and to the right of them.
Page 85: Figure 3.5: Neutrophil-Eosinophil Scatter
Principles of Operation Chapter 3 Search Book TOC Go Back All cells scatter a certain amount of 90 ° D light. The eosinophils scatter more 90 ° D light than any of the other cells because of the unique nature of granules they contain.
Page 86: Figure 3.6: Mononuclear Scatter
Chapter 3 Principles of Operation Search Book TOC Go Back The lymphocytes fall in the lowest large cluster. (The small population of cells below the lymphocytes contains particles that are unlikely to be WBCs.) The basophils fall in the cluster above and slightly to the right of the lymphocytes.
Page 87: Figure 3.7: Wbc Histograms
10 ° scatter on the X axis. All scatterplots may be displayed and printed at operator request. WBC Histograms The CELL-DYN 3000 can present the WBC scatter information as histograms. (See Figure 3.7.) These histograms may be displayed and printed at the operator's request.
Page 88: Wbc Parameters
Chapter 3 Principles of Operation Search Book TOC Go Back MONO-POLY Histogram The scatter information is plotted in a histogram format with the relative number of cells on the Y axis and the mononuclear and polymorphonuclear size distribution data on the X axis. LYM-BASO-MONO Histogram The scatter information is plotted in a histogram format with the relative number of cells on the Y axis and the lymphocyte, basophil and...
Page 89: Wbc Flagging
Principles of Operation Chapter 3 Search Book TOC Go Back Once the WBC count is determined, the absolute number of cells in each subpopulation is calculated by multiplying that WBC count by the percentage. The results are expressed as follows: # x 10 /µL # x 10...
Page 90: Rbc/Plt Measurement
Chapter 3 Principles of Operation Search Book TOC Go Back RBC/PLT Measurement Overview An impedance channel is used for the determination of RBC and PLT data. A 1:12,501 dilution of the sample is made with the Diluent. The cells are counted and sized using the Impedance method as they pass through the 60 x 72 µm aperture in the RBC/PLT transducer assembly.
Page 91: Rer
The CELL-DYN 3000 utilizes the volumetric metering process to regulate the count cycle and ensure that a precise volume of sample is used for the RBC/PLT measurement.
Page 92: Rbc/Plt Measurement
Chapter 3 Principles of Operation Search Book TOC Go Back The count portion of the cycle is initiated when the meniscus reaches the upper detector. The count cycle stops when the meniscus reaches the lower detector. The amount of time required for the meniscus to travel from the upper to the lower detector is called the RBC count time.
Page 93: Rbc Parameters
Principles of Operation Chapter 3 Search Book TOC Go Back The RBC count is corrected for coincidence and the pulses are edited by the RER before the MCV is derived. The PLT pulses are analyzed by the PLT algorithm as discussed in the PLT measurement section. RBC Parameters All numeric and frequency size distribution data are automatically displayed on the...
Page 94 Chapter 3 Principles of Operation Search Book TOC Go Back The Hematocrit (HCT) is the ratio of red blood cells to plasma and is expressed as a percentage of the whole blood volume. The HCT is calculated from the red blood cell count and the mean cell volume as follows: HCT = (RBC x MCV)/10 The Mean Corpuscular Hemoglobin (MCH) is the average weight of...
Page 95: Plt Measurement
Principles of Operation Chapter 3 Search Book TOC Go Back PLT Measurement Pulses counted in the RBC/PLT dilution between 1 and 35 fL are included in the PLT data. If the raw PLT count is estimated to be below a predetermined value, the instrument automatically continues to count PLTs for an extended count period.
Page 96: Figure 3.11: Plt Data And Histogram
Chapter 3 Principles of Operation Search Book TOC Go Back Figure 3.11: PLT Data and Histogram PLT Count The Platelet count is derived from the PLT histogram after the PLT data has been analyzed by the platelet algorithm. The PLT count is expressed as follows: PLT = # x 10 /µL...
Page 97: Platelet Flagging
Principles of Operation Chapter 3 Search Book TOC Go Back Platelet Distribution Width (PDW) is a measure of the heterogeneity of the PLT population. It is expressed as the geometric standard deviation. NOTE: PCT and PDW are not reportable parameters. Platelet Flagging Refer to the “Operational Messages and Data...
Page 98: Hemoglobin Measurement
Chapter 3 Principles of Operation Search Book TOC Go Back Hemoglobin Measurement Overview The HGB channel is used for the colorimetric determination of Hemoglobin. A 1:251 dilution of the sample is made with the diluent and the Hemoglobin Lyse reagent in the HGB mixing chamber. The HGB concentration is measured using a modified hemiglobincyanide method.
Page 99: Operational Messages And Data Flagging
Data Station RUN Screen, on printed reports and can be transmitted to a laboratory computer system. The CELL-DYN 3000 monitors 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, numeric, scatterplot and histogram data should be incorporated into the laboratory’s procedure and used to determine the need for further action...
Page 100: Parameter Flagging Messages
Chapter 3 Principles of Operation Search Book TOC Go Back Parameter Flagging Messages Table 3.1 summarizes all of the parameter flagging messages by parameter and category. Detailed descriptions of the messages are given on the following pages. Table 3.1: Parameter Flagging Messages Parameter Dispersional Data Alerts Suspect...
Page 101: Dispersional Data Alerts
Principles of Operation Chapter 3 Search Book TOC Go Back Dispersional Data Alerts These alerts are triggered by the numeric limits entered into the four patient limit sets (see the Set Up Instructions section of Chapter Operating Instructions, for an explanation). If results for a parameter exceed these limits, they are flagged on the screen and on the report.
Page 102 Chapter 3 Principles of Operation Search Book TOC Go Back WBC Flags WBC — displayed next to the WBC result Cause: 1. The count in a predefined region below the lymphocyte cluster on the size/complexity (0 ° /10 ° ) scatterplot is >10% of the total WBC count.
Page 103 Principles of Operation Chapter 3 Search Book TOC Go Back RBC Flags HGB — displayed next to RBC and HGB results (RBC and HGB are always displayed together) Cause: The relationship of the RBC and the HGB data do not meet expected criteria.
Page 104: Suspect Population Flags
Chapter 3 Principles of Operation Search Book TOC Go Back Action: Review the MCV and the PLT histogram. If the MCV is low and/or the histogram indicates an overlap (poor separation at the upper discriminator) in the RBC and PLT populations, review a stained smear to determine the cause and confirm the PLT count.
Page 105 Principles of Operation Chapter 3 Search Book TOC Go Back Action: Review a stained smear and follow your laboratory's review criteria. When bands are present, they are included in the total neutrophil count. IG (Immature Granulocyte) — displayed next to the NEU result The count in the region of scatter (on the 0 °...
Page 106: Interpretive Messages
Chapter 3 Principles of Operation Search Book TOC Go Back Action: Review a stained smear for nucleated red blood cells, platelet aggregates, sickle cells, or other abnormal cell types and follow your laboratory's review criteria. If NRBCs are present, they should be quantitated according to your laboratory's procedure;...
Page 107: Table 3.2: Interpretive Messages
Principles of Operation Chapter 3 Search Book TOC Go Back Table 3.2: Interpretive Messages Message Cause WBC Messages Leukopenia result exceeds the lower limit for WBC Leukocytosis result exceeds the upper limit for WBC Neutropenia result exceeds the lower limit for Neutrophil absolute number Neutrophilia result exceeds the upper limit for Neutrophil absolute number Lymphopenia...
Page 108: References
Chapter 3 Principles of Operation Search Book TOC Go Back 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.
Page 109 Principles of Operation Chapter 3 Search Book TOC Go Back NOTES 3-36 CELL-DYN® 3000 System Operator’s Manual 9140240E — May 1995...
Page 110: Chapter 4. System Specifications
Chapter 4 Search Book TOC Go Back System Specifications Chapter Table of Contents Physical Specifications — CELL-DYN 3000SL ....4-1 Power Specifications — CELL-DYN 3000SL ....4-2 Consumption .
Page 111 Chapter 4 Table of Contents Search Book TOC Go Back NOTES Table of Contents-2 CELL-DYN® 3000 System Operator’s Manual 9140240E — May 1995...
Page 112: Physical Specifications - Cell-Dyn 3000Sl
Chapter 4 Search Book TOC Go Back System Specifications Physical Specifications — CELL-DYN 3000SL Table 4.1: Dimensions Analyzer Data Station Printer Sample Loader Height 24" (61 cm) 24" (61 cm) 6" (15 cm) 17" (42 cm) Width 30" (76 cm) 15"...
Page 113: Power Specifications - Cell-Dyn 3000Sl
System Specifications Chapter 4 Search Book TOC Go Back Power Specifications — CELL-DYN 3000SL Table 4.3: Power Specifications Analyzer Input Requirements Setting Range Frequency 90—110 VAC 50/60 Hz 110—130 VAC 50/60 Hz 200—240 VAC 50/60 Hz 220—250 VAC 50/60 Hz Data Station Input Requirements Setting Range...
Page 114: Operational Specifications - Cell-Dyn 3000Sl
Chapter 4 System Specifications Search Book TOC Go Back Operational Specifications — CELL-DYN 3000SL Operating Environment Temperature Patient Samples: Room Temperature (15–30 Monocyte values exhibit a change at lower and higher temperatures. A 1.5% decrease is seen in the total monocyte percent at lower temperatures (<18 C).
Page 115: Throughput
System Specifications Chapter 4 Search Book TOC Go Back Throughput Maximum throughput = 72 samples/hour NOTE: Maximum throughput is achieved with normal samples that do not generate any instrument operational messages. Collection Tube and Sample Volume 13 mm diameter x 75 mm high with a Hemoguard style closure •...
Page 116: Bar Code Specifications - Cell-Dyn 3000Sl
Chapter 4 System Specifications Search Book TOC Go Back Bar Code Specifications — CELL-DYN 3000SL Bar Code Format The following formats with or without check digits are acceptable: • Code 39 • Interleave 2 of 5 • Codabar Bar Code Label Specifications Bar code labels must meet the following specifications: •...
Page 117: Physical Specifications - Cell-Dyn 3000Cs
System Specifications Chapter 4 Search Book TOC Go Back Physical Specifications — CELL-DYN 3000CS Table 4.4: Dimensions Analyzer Data Station Printer Height 24" (61 cm) 24" (61 cm) 6" (15 cm) Width 30" (76 cm) 15" (38 cm) 16.5" (41 cm) Depth 22"...
Page 118: Power Specifications - Cell-Dyn 3000Cs
Chapter 4 System Specifications Search Book TOC Go Back Power Specifications — CELL-DYN 3000CS Table 4.6: Power Specifications Analyzer Input Requirements Setting Range Frequency 90—110 VAC 50/60 Hz 110—130 VAC 50/60 Hz 200—240 VAC 50/60 Hz 220—250 VAC 50/60 Hz Data Station Input Requirements Setting Range...
Page 119: Operational Specifications - Cell-Dyn 3000Cs
System Specifications Chapter 4 Search Book TOC Go Back Operational Specifications — CELL-DYN 3000CS Operating Environment Temperature Patient Samples: Room Temperature (15–30 Monocyte values exhibit a change at lower and higher temperatures. A 1.5% decrease is seen in the total monocyte percent at lower temperatures (<18 C).
Page 120: Measurement Specifications
Chapter 4 System Specifications Search Book TOC Go Back Measurement Specifications — CELL-DYN 3000SL and CS Measurement Channels Impedance channel for both RBC and PLT Laser Optics for WBC and Differential Hemoglobin Absorbance WBC and Differential Method Laser light scatter Light Source Vertically polarized 5–10 mW helium neon laser Wavelength...
Page 121: Performance Specifications
System Specifications Chapter 4 Search Book TOC Go Back Performance Specifications — CELL-DYN 3000SL and CS Background Counts (acceptable up to limits listed) <0.50 K/µL <0.05 M/µL <0.20 g/dL <10.0 K/µL Precision Samples that are used to verify precision specifications should have results that fall within the laboratory's normal range.
Page 122: Wbc Differential Parameters
Chapter 4 System Specifications Search Book TOC Go Back WBC Differential Parameters Precision specifications for the WBC Differential parameters are given as a 95% confidence limit for a range of values for each of the WBC subpopulations. Table 4.8: Precision of the WBC Differential Parameters Cell Type Range 95% Confidence Limit...
Page 123: Accuracy
Book TOC Go Back Accuracy The CELL-DYN 3000 system can be calibrated to agree with reference values within the allowable calibration ranges. Both modes of operation, Open and Closed (CS and SL) may be calibrated. Thus, it is possible to compensate for differences between modes due to differing aspiration pathways or operational sequences.
Page 124: Carryover
Chapter 4 System Specifications Search Book TOC Go Back Carryover Carryover is determined by running samples with high concentrations of WBCs, RBCs, HGB and PLTs. Each sample is run in triplicate followed by three background cycles. The percent carryover is calculated using the following formula: % Carryover = Background...
Page 125 System Specifications Chapter 4 Search Book TOC Go Back NOTES 4-14 CELL-DYN® 3000 System Operator’s Manual 9140240E — May 1995...
Page 126: Chapter 5. Operating Instructions
Chapter 5 Search Book TOC Go Back Operating Instructions Chapter Table of Contents Introduction ..........5-1 Data Station Program Overview .
Page 127 Chapter 5 Table of Contents Search Book TOC Go Back Anticoagulant ........5-67 Sample Stability .
Page 128 Chapter 5 Table of Contents Search Book TOC Go Back Using the Work List Without Bar Codes ... . 5-94 Sample Analysis Procedure ..... . 5-94 Running STAT Samples .
Page 129 Chapter 5 Table of Contents Search Book TOC Go Back NOTES Table of Contents-4 CELL-DYN® 3000 System Operator’s Manual 9140240E — May 1995...
Page 130: Introduction
Chapter 5 Search Book TOC Go Back Operating Instructions Introduction This chapter discusses the operation of the CELL-DYN® 3000. It is divided into three sections: Set Up Instructions, Routine Operation Using the Data Log. The chapter also includes an overview of the Data Station computer program.
Page 131: Main Menu Screen
Operating Instructions Chapter 5 Search Book TOC Go Back Main Menu Screen The MAIN MENU Screen is divided into four sections. The upper left- hand corner shows the current version of the instrument software. The upper right-hand corner shows the current date and time, operator ID and the sequence number.
Page 132: Conventions Used In This Manual
Chapter 5 Operating Instructions Search Book TOC Go Back The MAIN MENU key labels are displayed across the bottom of the screen. Conventions Used in This Manual Please refer to the introduction of this manual for a key to style conventions used in this and other chapters.
Page 133 Operating Instructions Chapter 5 Search Book TOC Go Back NOTES CELL-DYN® 3000 System Operator’s Manual 9140240E — May 1995...
Page 134: Setup Instructions
Chapter 5 Operating Instructions Search Book TOC Go Back Setup Instructions This section discusses the options available when the [SETUP] 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 135: Figure 5.3: Date/Time Setup Screen
Operating Instructions Chapter 5 Search Book TOC Go Back DATE/TIME SETUP Dec 08 1992 15:52 Ready Operator ID Sequence # 0067 Enter desired date display option and/or set date and time: 1: Month/Day/Year 2: Day/Month/Year 3: Year/Month/Day 4: Year/Day/Month Date (Month/Day/Year): --/--/-- Time (00:00 to 23:59): --:-- RETURN Figure 5.3:...
Page 136: Procedure Date/Time
Chapter 5 Operating Instructions Search Book TOC Go Back The desired format is selected by typing the corresponding number in the entry field displayed to the left of the list (1). When the Enter key on the keyboard is pressed, the selected format is displayed in the <DATE>...
Page 137: Figure 5.4: Patient Limits Screen
Operating Instructions Chapter 5 Search Book TOC Go Back LIMIT SET 1 Jun 30 1992 11:15 Ready Operator ID Sequence # 6799 Lower Limits Upper Limits WBC: K/uL 10.2 K/uL NEU: K/uL 37.0 K/uL 80.0 LYM: K/uL 10.0 K/uL 50.0 MONO: K/uL K/uL...
Page 138: Procedure Patient Limit Sets
Chapter 5 Operating Instructions Search Book TOC Go Back NOTE: The key label for the limit set displayed on the screen is not shown. Four different sets of limits may be entered. Whenever a parameter result exceeds an entered limit, the result is displayed in color on the screen to alert the operator.
Page 139 Operating Instructions Chapter 5 Search Book TOC Go Back DILUENT LOG Dec 17 1992 16:30 Ready Operator ID Sequence # 0630 Package Size Lot Number Expiration Date Open Date 013511 02/28/93 12/02/92 013511 02/28/93 12/17/92 --------- --/--/-- --/--/-- --------- --/--/-- --/--/-- --------- --/--/--...
Page 140: Procedure Reagent Log Entry
Chapter 5 Operating Instructions Search Book TOC Go Back When the [REAGENT LOG] key is pressed, one of the logs is displayed as shown in Figure 5.5. (The name of the displayed log is indicated in the Status Box). The other two logs may be displayed by pressing the appropriate soft key.
Page 141: Figure 5.6: Qc Setup Menu Screen
Operating Instructions Chapter 5 Search Book TOC Go Back 4. Press [COMPLETE DELETION] to delete the selected entry and create a space at the bottom of the log. 5. If desired, a new entry may then be made as directed in the above Entry Procedure.
Page 142: Figure 5.7: X-B Setup Screen
Chapter 5 Operating Instructions Search Book TOC Go Back This section discusses the procedures that are used to set up the QC files. The keys are discussed in the order they are used to set up a QC file. X-B SETUP Dec 08 1992 16:10 Ready...
Page 143: Procedure X-B Setup
Operating Instructions Chapter 5 Search Book TOC Go Back The numbers on the X-B SETUP Screen shown in Figure 5.7 correspond to the following numbered options: 1. LOWER/UPPER LIMITS The Lower and Upper Limits determine which patient results will be used in the X-B Moving Average calculation. Results that fall outside these limits are automatically excluded from the X-B calculations.
Page 144 Chapter 5 Operating Instructions Search Book TOC Go Back 7. Press [RETURN] to return to the QC SETUP MENU Screen. NOTE: The X-B status is shown on the RUN Screen DISPLAY SPECIMEN Screen below the Data Station Status Box (for example, X-B: 10/IN or X-B: 13/OUT2). The number of specimens in the current X-B batch is noted (1-19).
Page 145: Range And Limit Entry And File Updating
Operating Instructions Chapter 5 Search Book TOC Go Back Range and Limit Entry and File Updating The [QC LIMITS] key is used to display the QC MEANS/LIMITS ENTRY Screen and the following soft key labels: LIMITS RANGE ENTRY or MEANS/LIMITS (The key label alternates between these two selections.)
Page 146 Chapter 5 Operating Instructions Search Book TOC Go Back QC RANGE ENTRY Jun 08 1992 10:23 Ready Operator ID Sequence # 9110 FOR NORM RD43 SL Upper Limits Lower Limits K/uL WBC: K/uL 55.3 K/uL 47.3 NEU: K/uL K/uL 37.5 31.5 LYM: K/uL...
Page 147 Operating Instructions Chapter 5 Search Book TOC Go Back 7. Press [RETURN] to save the entries and return to the QC SETUP MENU Screen. NOTE: When the entries are saved, the software checks to see if any entries would result in the upper limit being less than the lower limit.
Page 148 Chapter 5 Operating Instructions Search Book TOC Go Back 4. Type the numbers and press the Enter key on the keyboard to save each entry and advance the cursor to the next entry field. 5. Repeat step 4 until all entries have been made. 6.
Page 149 Operating Instructions Chapter 5 Search Book TOC Go Back The feature enabling the transfer of QC limits and data into a QC file from a floppy disk is not currently available. Therefore the following LOAD keys mentioned in this manual should not be used at this time: [LAB ID FROM DISK SETUP], [LOAD FROM DISK], and [WRITE QC TO DISK].
Page 150: Figure 5.10: Replicate Id Entry Screen
Chapter 5 Operating Instructions Search Book TOC Go Back QC FILE SETUP Dec 17 1992 16:36 Ready Operator ID Sequence # 0630 FOR Low Replicate ID: ------------ WESTGARD RULE SELECTION: RULE 1: Value outside 3 SD. RULE 2: Two consecutive values outside SAME 2 SD. RULE 3: Two consecutive values outside OPPOSITE 2 SD.
Page 151: Procedure Qc File Setup
Operating Instructions Chapter 5 Search Book TOC Go Back QC FILE SETUP Dec 17 1992 16:35 Ready Operator ID FOR Low Sequence # 0630 Lot Number: 12345 Expiration Date (Month/Day/Year): 11/30/92 WESTGARD RULE SELECTION: RULE 1: Value outside 3 SD. RULE 2: Two consecutive values outside SAME 2 SD.
Page 152 Chapter 5 Operating Instructions Search Book TOC Go Back 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> entry field. 3.
Page 153 Operating Instructions Chapter 5 Search Book TOC Go Back CUSTOMIZE QC DISPLAY Dec 08 1992 16:07 Ready Operator ID Sequence # 0067 FOR FILE 1 Group 1: MONO EOS BASO Group 2: MCH MCHC RDW Group 3: UMT1 CNT1 Group 4: MONO EOS BASO MCH MCHC RDW...
Page 154: Procedure Customize Qc Log Display
Chapter 5 Operating Instructions Search Book TOC Go Back On the CUSTOMIZE QC DISPLAY Screen, Parameter Group 1 is displayed (in the order indicated from left to right) on the first VIEW QC LOG Screen. The remaining groups are displayed on subsequent screens that are accessed by pressing the Right Arrow key on the keyboard.
Page 155: Showing Standard Groups
Operating Instructions Chapter 5 Search Book TOC Go Back CUSTOMIZE QC DISPLAY Dec 08 1992 16:07 Ready Operator ID Sequence # 0067 FOR FILE 1 Group 1: NEU LYM MONO EOS BASO Group 2: HGB HCT MCV MCH MCHC Group 3: MPV PCT Group 4: NEU LYM MONO EOS...
Page 156 QC file to store information generated by latex particles. Information is stored for each of the four angles of scatter which are used to determine the differential. This key is intended for Abbott Service personnel. 5-27 CELL-DYN® 3000 System Operator’s Manual...
Page 157 Operating Instructions Chapter 5 Search Book TOC Go Back CUSTOMIZE QC PRINTOUT Dec 17 1992 16:49 Ready Operator ID Sequence # 0630 FOR Normal WBC %N %L %M %E %B RBC HGB HCT MCV MCH MCHC RDW PLT MPV UMT1 CNT1 MONO EOS BASO MCH MCHC RDW...
Page 158: Procedure Customize Qc Log Printout
Chapter 5 Operating Instructions Search Book TOC Go Back CNT1 and CNT2 — CNT1 is the RBC/PLT Count Time. CNT2 is the RBC/PLT Count Time for an extended count. The [STANDARD SELECTION] key is used to automatically arrange the parameters in a predetermined print group. Procedure Customize QC Log Printout 1.
Page 159: Figure 5.15: Operation Setup Menu Screen
Operating Instructions Chapter 5 Search Book TOC Go Back OPERATION SETUP MENU Dec 08 1992 16:11 Ready Operator ID Sequence # 0067 BARCODE COMPUTER RETURN SETUP SETUP Figure 5.15: Operation Setup Menu Screen The OPERATION SETUP MENU Screen (see Figure 5.15) allows the operator to configure the transmission to an on-line computer.
Page 160: Procedure Bar Code Set Up
Chapter 5 Operating Instructions Search Book TOC Go Back BAR CODE SET UP Dec 08 1992 16:12 Ready Operator ID Sequence # 0068 Bar Code Symbology (1=CODE39, 2=I2OF5, 3=CODABAR) Bar Code Check Digit SET UP Figure 5.16: Bar Code Set Up Screen The [BAR CODE SETUP] key is used to select the type of bar code to be read and to enable or disable the check digit option for a specific bar BAR CODE...
Page 161 The CELL-DYN 3000 can transmit data to an on-line computer (Laboratory Information System). Data may be transmitted automatically as each sample is run or at the operator’s request. The CELL-DYN 3000 also can receive patient information transmitted to it by the on-line computer.
Page 162 Chapter 5 Operating Instructions Search Book TOC Go Back COMPUTER SETUP Screen is used to configure the transmission format to meet the requirements of the Laboratory Information System or on-line computer. Instructions for using this option are given after the following description of the soft keys.
Page 163: Procedure Computer Setup
Operating Instructions Chapter 5 Search Book TOC Go Back Auto-transmission of NON-ALERTED graphic data When this option is enabled, histograms and scatterplots are automatically transmitted to the LIS for any sample without flagged results. 5. The remaining options are configured according to the requirements of the LIS: Transmission CTS enabled Transmission Data bits (7, 8)
Page 164: Figure 5.18: Units Selection Screen
Chapter 5 Operating Instructions Search Book TOC Go Back UNITS SELECTION Dec 08 1992 16:16 Ready Operator ID Sequence # 0070 Parameters SI MOD MIXED WBC: K/uL 10e9/L 10e3/uL RBC: M/uL 10e12/L 10e6/uL HGB: g/dL mmol/L HCT: RDW: PLT: K/uL 10e9/L 10e3/uL PCT:...
Page 165: Procedure Units Selection
Operating Instructions Chapter 5 Search Book TOC Go Back TABLE 5.1: Report Units SI MOD MIXED Parameter Value Units Value Units Value Units Value Units WBC* 5.32 K/µL 5.32 5.32 10e9/L 5.32 10e3/µL 5.15 M/µL 5.15 5.15 10e12/L 5.15 10e6/µL 16.2 g/dL 10.1***...
Page 166: Figure 5.19: Customize Displayed Report Screen
Chapter 5 Operating Instructions Search Book TOC Go Back The [CUSTOMIZE REPORT] key is used to customize the displayed and printed report. Three options are available: CUSTOMIZE REPORT CUSTOMIZE DISPLAY CUSTOMIZE PRINTOUT CUSTOMIZE HEADER The [CUSTOMIZE REPORT] key may also be accessed from the RUN Screen and the DISPLAY SPECIMEN Screen...
Page 167: Procedure Customize Display
Operating Instructions Chapter 5 Search Book TOC Go Back PARAM SET 2* PARAM SET 3* PARAM SET 4* CUSTOMIZE PRINTOUT CUSTOMIZE HEADER or CANCEL GRAPH (This key label alternates between these two selections when [SELECT GRAPH] is pressed.) SELECT GRAPH or PLACE GRAPH or TOGGLE PARAMETER (The key label alternates among...
Page 168 Chapter 5 Operating Instructions Search Book TOC Go Back NOTE: The [TOGGLE PARAMETER] key is displayed only when the cursor is positioned in the list of individual parameters displayed on this section of the screen. 5. When all parameter selections have been made, move the cursor to the top of the parameter list and use the Arrow keys on the keyboard to move the cursor to the desired scatterplot or histogram listed on the left side of this section of the screen.
Page 169 Operating Instructions Chapter 5 Search Book TOC Go Back CUSTOMIZE HEADER TOGGLE ON/OFF SETUP RESTORE HEADER (Displayed after other keys are pressed.) BLANK HEADER (Displayed after other keys are pressed.) When the [TICKET PRINTER] key is pressed, the following soft key label is also displayed: BLANK TICKET or PRE-PRNTD TICKET...
Page 170: For The Graphics Printer
Chapter 5 Operating Instructions Search Book TOC Go Back The [SETUP] key is used to return to the SETUP Menu Screen. SETUP CUSTOMIZE PRINTED REPORT Dec 08 1992 16:58 Ready Operator ID Sequence # 0630 GRAPHICS PRINTER AUTO-PRINT results for ALERTED specimens AUTO-PRINT results for NON-ALERTED specimens Print graphs for ALERTED specimens only Print PCT, PDW results...
Page 171 Operating Instructions Chapter 5 Search Book TOC Go Back When this option is enabled, scatterplots and histograms are printed only for samples with flagged results. 4. Print PCT, PDW results When this option is enabled, the results for PCT and PDW are printed on the report.
Page 172 Chapter 5 Operating Instructions Search Book TOC Go Back Procedure Customize Graphics Report 1. From the CUSTOMIZE REPORT Screen if necessary, press [GRAPHICS PRINTER] to display the CUSTOMIZE PRINTED REPORT Screen for the Graphics Printer. 2. Use the Arrow keys on the keyboard to move the cursor to the desired selection.
Page 173 Operating Instructions Chapter 5 Search Book TOC Go Back The [CUSTOMIZE HEADER] key is used to customize the header for the graphics report. (See Figure 5.21.) Any report printed in a graphics CUSTOMIZE format will be printed with this header. The following soft key labels are HEADER displayed when the [CUSTOMIZE HEADER] key is pressed: RESTORE HEADER...
Page 174: For Pre-Printed Tickets
Chapter 5 Operating Instructions Search Book TOC Go Back 6. Press the Enter key on the keyboard to save the entry and advance the cursor. 7. Repeat steps 5 and 6 for each line of the header. 8. Press [SETUP] to return to the SETUP MENU Screen.
Page 175 Operating Instructions Chapter 5 Search Book TOC Go Back When the [PRE-PRNTD TICKET] key is pressed, the CUSTOMIZE PRINTED REPORT Screen is displayed. The numbers on the screen PRE-PRNTD shown in Figure 5.22 correspond to the following numbered options: TICKET 1.
Page 176: For Blank Tickets
Chapter 5 Operating Instructions Search Book TOC Go Back CUSTOMIZE PRINTED REPORT Dec 18 1992 08:57 Ready Operator ID Sequence # 0630 TICKET PRINTER - BLANK TICKET AUTO-PRINT results for ALERTED specimens AUTO-PRINT results for NON-ALERTED specimens Print PCT, PDW results Print Limits Report Print Specific Alerts Print Manual Differential Grid for ALERTED specimens...
Page 177 Operating Instructions Chapter 5 Search Book TOC Go Back 4. Print PCT, PDW results When this option is enabled, the results for PCT and PDW are printed on the report. NOTE: Clinical significance has not been established for these parameters. Therefore, they are not reportable. 5.
Page 178 Chapter 5 Operating Instructions Search Book TOC Go Back 3. Press [TOGGLE ON/OFF] to enable or disable the selection. 4. Repeat steps 2 and 3 until all selections have been made. 5. A numeric entry is required for the <LINE-FEEDS PER PAGE FOR TICKET PRINTER>...
Page 179 Operating Instructions Chapter 5 Search Book TOC Go Back NOTES 5-50 CELL-DYN® 3000 System Operator’s Manual 9140240E — May 1995...
Page 180: Routine Operation
Go Back Routine Operation Introduction This section contains information and procedures that are recommended for the routine operation of the CELL-DYN 3000. The Sample Analysis section gives instructions for running samples on both the Sample Loader Closed Sampler versions of the CELL-DYN 3000. For convenience, instructions for running samples in the Open Mode are included in each section.
Page 181: Data Station Run Menu
Operating Instructions Chapter 5 Search Book TOC Go Back Data Station Run Menu Next ID___________ Auto Dec 18 1992 09:43 Ready Operator ID Patient___________ Sequence # 0630 Sex(M/F):- DOB:--/--/-- XB: 13/IN Open Sampler Dr_________________ Param Set: 1 Limits: 3 K/uL MONO BASO M/uL...
Page 182: Data Station Run Screen
Chapter 5 Operating Instructions Search Book TOC Go Back Data Station Run Screen The Upper Left Corner of the Data Station RUN Screen for patient samples displays the following data entry fields on lines 1–5: 1. NEXT ID This field is used to enter the ID number for the next sample to be run.
Page 183: Status Box
Operating Instructions Chapter 5 Search Book TOC Go Back Status Box The Status Box is displayed in the Top Center of the Data Station RUN Screen. It contains the following information: • Menu in use • The Status of the Analyzer — the READY, NOT READY and FAULT messages are displayed here •...
Page 184: Bulletin Line
Chapter 5 Operating Instructions Search Book TOC Go Back Bulletin Line The Bulletin Line is displayed immediately above the key labels. Messages appear in this line to identify status or fault conditions. An example of a Bulletin Line message is shown in Figure 5.25. Next ID _________Auto Dec 18 1992 09:43...
Page 185: Flagging Diagnostics Screen
Operating Instructions Chapter 5 Search Book TOC Go Back Spec ID FLAGGING DIAGNOSTICS May 28 1993 16:10 Sequence # Ready Operator ID ---- Sequence # Closed Sampler SUSPECT BAND FLAG ESTIMATE BAND REGION %: X.X% IG FLAG ESTIMATE REGION %: X.X% BLAST FLAG ESTIMATE BLAST...
Page 186 Chapter 5 Operating Instructions Search Book TOC Go Back The Spec ID and Sequence Number for the specimen displayed appears in the upper left hand corner of the display and printout. The information in the upper right hand corner displays the current operational status of the Analyzer.
Page 187: Data Station Run Screen Soft Keys
Operating Instructions Chapter 5 Search Book TOC Go Back Data Station Run Screen Soft Keys A brief description of the function of each key is given in this section. Instructions for running samples and using the Work List are given in the Sample Analysis sections of this chapter.
Page 188 Chapter 5 Operating Instructions Search Book TOC Go Back This key is used to display the WORK LIST Screen. (See Figure 5.27.) The following soft key labels are displayed when the [WORK LIST] WORK key is pressed: LIST WORK LIST ON or WORK LIST OFF (The key label alternates between these two selections.)
Page 189 Operating Instructions Chapter 5 Search Book TOC Go Back SPECIMEN TYPE Dec 18 1992 09:55 Ready Operator ID Sequence # 0630 File Name # Specimens File Name # Specimens Patient Normal FILE 12 High FILE 13 FILE 14 normal FILE 15 high FILE 16 Replicate...
Page 190 Chapter 5 Operating Instructions Search Book TOC Go Back Next ID___________Auto Dec 18 1992 09:51 Patient ___________ Ready Operator ID Sequence # 0630 Sex(M/F):- DOB:--/--/-- XB: 13/OUT2 Open Sampler Dr ___________________ Param Set: 1 Limits: 3 WBC: K/uL NEU: LYM: MONO: EOS: BASO:...
Page 191 Operating Instructions Chapter 5 Search Book TOC Go Back Dec 18 1992 09:53 Type Low 11/120 Ready Operator ID Sequence # 0630 Param Set: 1 Open Sampler WBC: K/uL NEU: LYM: MONO: EOS: BASO: COMPLEXITY ORTHOGONAL RBC: M/uL HGB: g/dL HCT: MCV: MCH:...
Page 192 Chapter 5 Operating Instructions Search Book TOC Go Back Dec 18 1992 09:51 Type BACKGROUND Ready Operator ID Sequence # 0630 Param Set: 1 Open Sampler WBC: K/uL NEU: LYM: MONO: EOS: BASO: RBC: M/uL COMPLEXITY ORTHOGONAL HGB: g/dL HCT: MCV: MCH: MCHC:...
Page 193 ELEC BKGND in the data log and are automatically excluded from the X-B analysis. The [LATEX] key is used to select the run mode for latex particles and display the RUN Screen for them. This key is used by Abbott service LATEX personnel.
Page 194 Chapter 5 Operating Instructions Search Book TOC Go Back The [RESISTANT RBC] key is used to initiate the Resistant RBC cycle. This cycle is used to process samples containing RBCs that are resistant RESISTANT to the lytic action of the Sheath reagent. The sample is held in the WBC mixing chamber for approximately 15 seconds longer than the normal mixing time.
Page 195: Procedure Resistant Rbc
Operating Instructions Chapter 5 Search Book TOC Go Back Procedure Resistant RBC 1. If necessary, from the Screen, press [CHANGE SAMPLER] to select the Open Mode. 2. Press [SPECIMEN TYPE] followed by [RESISTANT RBC] to select the Resistant RBC cycle. 3.
Page 196: Sample Collection And Handling
Chapter 5 Operating Instructions Search Book TOC Go Back Sample Collection and Handling WARNING: Potential Biohazard. Consider all clinical specimens and controls, calibrators, etc. that contain human blood or serum as potentially infectious. Use established, good laboratory working practices when handling these samples. Wear gloves, lab coats and suitable eye protection and follow other biosafety practices as specified in the OSHA Bloodborne Pathogen Rule or other equivalent biosafety procedures.
Page 197: Sample Collection
This ensures an adequate amount of blood for the Open Mode (170 µL) aspiration. Interfering Substances The CELL-DYN 3000 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.
Page 198: Sample Analysis
Chapter 5 Operating Instructions Search Book TOC Go Back Sample Analysis Introduction This section explains how samples are run on the Sample Loader and Closed Sampler instruments. Samples should not be run until the instrument has been properly started up and daily QC checks have been performed.
Page 199: Alerts And Indicators
Operating Instructions Chapter 5 Search Book TOC Go Back 2. An Auto Increment feature is available that automatically increments the sample ID number by 1 each time a sample is run. It is selected by moving the cursor to the word AUTO displayed at the end of the <NEXT ID>...
Page 200 Chapter 5 Operating Instructions Search Book TOC Go Back • Results that fall outside the range of the selected limit set are displayed in color. Yellow indicates that the result exceeded the lower limit and magenta indicates that the result exceeded the upper limit.
Page 201: Instrument Start Up
Operating Instructions Chapter 5 Search Book TOC Go Back Instrument Start Up The Analyzer and Data Station power switches should be left ON at all times. The instrument has been designed to automatically maintain itself when it is idle. If the instrument is idle for five minutes, a cleaning cycle is automatically initiated.
Page 202: Sample Analysis On The Cell-Dyn 3000Sl
Chapter 5 Operating Instructions Search Book TOC Go Back Sample Analysis on the CELL-DYN 3000SL Daily Start Up Procedure The automatic Start Up cycle is designed to prime the flow system and run background counts whenever the STANDBY or INITIALIZED message appears in the Status Box on the Data Station RUN Screen.
Page 203: Daily Quality Control Checks
Operating Instructions Chapter 5 Search Book TOC Go Back Sample Loader Operating Tips 1. All Sample Loader tubing must be connected before turning on the Sample Loader, initializing it, or changing modes. 2. All samples must be properly mixed before they are placed in the Sample Loader racks.
Page 204 Chapter 5 Operating Instructions Search Book TOC Go Back Closed Mode QC QC samples may be run on the Sample Loader using the “Q Labels,” which are bar code labels provided with the Sample Loader. Each label is designated Qx, where x indicates the file number. If these labels are placed on the control tubes, the results are automatically transmitted to the file indicated by the label.
Page 205 Operating Instructions Chapter 5 Search Book TOC Go Back 13. If the results are unacceptable, repeat the run. If the results are still unacceptable, obtain a new tube of control, be sure that it is warmed and mixed properly according to the manufacturer’s recommendations and again repeat the run.
Page 206: Running Samples
Chapter 5 Operating Instructions Search Book TOC Go Back 15. Repeat steps 12–14 for all levels of controls that were run. 16. If the results are unacceptable, repeat the run. If the results are still unacceptable, obtain a new tube of control, be sure that it is warmed and mixed properly and again repeat the run.
Page 207 Operating Instructions Chapter 5 Search Book TOC Go Back 6. When the cycle is completed, the probe moves down, the word “Ready” on the Analyzer status indicator panel is illuminated in green and the results are displayed on the Data Station RUN Screen.
Page 208: Daily Shutdown
Chapter 5 Operating Instructions Search Book TOC Go Back 4. Place the racks in the Sample Loader tray with the slotted side facing the Analyzer. NOTE: All 10 racks must be in the tray (5 on each side) for the Sample Loader to operate.
Page 209: Sample Analysis On The Cell-Dyn 3000Cs
Operating Instructions Chapter 5 Search Book TOC Go Back Sample Analysis on the CELL-DYN 3000CS Daily Start Up Procedure The automatic Start Up cycle is designed to prime the flow system and run the background counts whenever the STANDBY or INITIALIZED message appears in the Status Box on the Data Station RUN Screen.
Page 210: Running Samples
Chapter 5 Operating Instructions Search Book TOC Go Back QC (Open or Closed Mode) Procedure 1. From the Data Station 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.
Page 211 Operating Instructions Chapter 5 Search Book TOC Go Back 3. Open the well-mixed sample tube and immerse the open sample aspiration probe in the sample. 4. Press the touch plate located behind the probe to start the cycle. The word “Busy” on the Analyzer status indicator panel is illuminated in yellow.
Page 212: Daily Shutdown
Chapter 5 Operating Instructions Search Book TOC Go Back NOTE: The touch plate will not operate if the tube is not seated correctly. (If necessary, refer to the Special Procedures section in Chapter 9, Maintenance, for instructions for adjustment of the Tube Retainer.) 4.
Page 213: Using The Work List
(including the preassigned information) that the operator intends to run on the instrument. A Work List can be downloaded from a host computer to the CELL-DYN 3000. The use of the Work List is optional. Detailed discussions of using the Work List with and without bar coded samples are provided in this section.
Page 214: Work List Menu
Chapter 5 Operating Instructions Search Book TOC Go Back Work List Menu The [WORK LIST] key is displayed on the Data Station RUN Screen. WORK LIST Screen and the following soft key labels are displayed WORK when the [WORK LIST] key is pressed: LIST WORK LIST ON or WORK LIST OFF...
Page 215 Operating Instructions Chapter 5 Search Book TOC Go Back Work List Screen WORK LIST Screen is depicted in Figure 5.34. The numbers on the screen shown in Figure 5.34 correspond with the following numbered options: 1. WORK LIST The status of the Work List (OFF or ON) is displayed in this field. 2.
Page 216: Work List Soft Keys
Chapter 5 Operating Instructions Search Book TOC Go Back 8. PARAM This field is used to enter the number of the Parameter Set that will be used for the sample. If no entry is made, the default (preselected) Parameter Set is used. 9.
Page 217 Operating Instructions Chapter 5 Search Book TOC Go Back The [BAR CODE ON] key is used to create a Work List for samples that are identified with bar code labels. The key label changes to [BAR BAR CODE CODE OFF] when the Bar code feature is enabled. The upper left corner of the display indicates the status of the Bar Code feature.
Page 218: Figure 5.35: Work List Setup Screen
Chapter 5 Operating Instructions Search Book TOC Go Back These keys are used to confirm or cancel the Purge Completed command. NOTE: The Purge Completed option is not available when the Bar Code feature is OFF. WORK LIST SETUP Dec 18 1992 10:09 Operator ID Ready...
Page 219 Operating Instructions Chapter 5 Search Book TOC Go Back 3. Limit Set entry selected This field is used to specify which Patient Limits are assigned to each sample. The Default Limit Set (see option 4) is used if no specification is made. 4.
Page 220: Sample Analysis Using The Work List, Sample Loader Instruments
Sample Loader Instruments NOTE: The Work List is active in the Closed Mode only on the Sample Loader version of the CELL-DYN 3000. Using the Work List with Bar Codes The Sample Loader has a built-in bar code reader that automatically reads a bar code label placed on the tube.
Page 221 Operating Instructions Chapter 5 Search Book TOC Go Back When a laboratory-generated bar code number is used (Laboratory Specimen ID option selected in the Work List Set Up), this number must be typed in the Work List <SPECIMEN ID> field. The samples are identified on the Data Station RUN Screen and in the Data Log by this...
Page 222 Chapter 5 Operating Instructions Search Book TOC Go Back 5. Type the appropriate sample identification information in the <SPECIMEN ID> and <SPECIMEN NAME> (if selected) entry fields on the Work List. Press the ENTER key on the keyboard to save the entry in each field and advance the cursor. 6.
Page 223 Operating Instructions Chapter 5 Search Book TOC Go Back Using the Work List Without Bar Codes When the Bar Code OFF option is selected, samples must be run in the order in which the information has been entered in the Work List, since the Work List is accessed sequentially as the samples are processed.
Page 224 Chapter 5 Operating Instructions Search Book TOC Go Back 6. After the information for the sample is entered, place the sample in a Sample Loader rack. Subsequent samples should be placed in the racks in the order in which the sample information is entered into the Work List.
Page 225: Sample Analysis With The Work List, Closed Sampler Instruments
Closed Sampler Instruments The Work List may be used in the Open and Closed modes on the Closed Sampler version of the CELL-DYN 3000. On CS instruments, use of the Work List is identical in both modes so they are discussed together.
Page 226 Chapter 5 Operating Instructions Search Book TOC Go Back 4. Type the appropriate sample identification information in the <SPECIMEN ID> and <SPECIMEN NAME> (if selected) entry fields on the Work List. Press the Enter key on the keyboard to save the entry in each field and advance the cursor.
Page 227 Operating Instructions Chapter 5 Search Book TOC Go Back Using the Work List with Bar Code OFF When the Bar Code OFF option is selected, the samples must be run in the order in which the information has been entered in the Work List, since the Work List is accessed sequentially as the samples are processed.
Page 228 Chapter 5 Operating Instructions Search Book TOC Go Back 9. If necessary, press [CHANGE SAMPLER] to select the desired mode. 10. Run the well-mixed samples in the order in which the information was entered in the Work List. NOTE: If desired, samples may be run with the WORK LIST Screen displayed.
Page 229 Operating Instructions Chapter 5 Search Book TOC Go Back NOTES 5-100 CELL-DYN® 3000 System Operator’s Manual 9140240E — May 1995...
Page 230: Using The Data Log
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 3000. The record information is stored chronologically by sequence number. Scatterplots and histograms are stored for the most current 2,000 records.
Page 231 Operating Instructions Chapter 5 Search Book TOC Go Back When the [DATA LOG] key is pressed, the DATA LOG Screen and the following soft key labels are displayed: DATA EDIT ID* DISPLAY SPECIMEN FIND SPECIMEN REJECT FROM X-B** CUSTOMIZE DATA LOG TRANSMIT DATA PRINT DATA LOG MAIN...
Page 232 Chapter 5 Operating Instructions Search Book TOC Go Back Spec ID R5 T1 DISPLAY SPECIMEN Dec 18 1992 09:43 Patient_____________ Ready Operator ID Sequence # 0630 Sex(M/F):- DOB:--/---/-- Sequence # 2856 Open Sampler Dr_____________ Param Set: 1 Limits: 1 WBC: 5.9 K/uL NEU: 54.0 %N...
Page 233 Operating Instructions Chapter 5 Search Book TOC Go Back The [PREVIOUS SPECIMEN] key is used to display the results for the sequence number preceding the one currently displayed without PREVIOUS returning to the main DATA LOG Screen. SPECIMEN The [NEXT SPECIMEN] key is used to display the results for the sequence number following the one currently displayed without NEXT returning to the main DATA LOG Screen.
Page 234 Chapter 5 Operating Instructions Search Book TOC Go Back SEQ # : DATA LOG SEARCH Apr 30 1993 15:23 SPEC ID: Ready Operator ID NAME : Sequence # 4659 Date Time Op Seq Specimen ID MCV PLT 5.02 16.4 93.0 501.
Page 235 Operating Instructions Chapter 5 Search Book TOC Go Back NOTE: If all samples are rejected from the current X-B batch, it is not possible to accept any of them back into the X-B analysis. CUSTOMIZE DISPLAY Dec 18 1992 10:29 Ready Operator ID Sequence #...
Page 236 Chapter 5 Operating Instructions Search Book TOC Go Back CUSTOMIZE DISPLAY FOR DATA LOG Screen displays a matrix showing the four parameter groups and a list of the available parameters. Parameter group 1 is displayed (in the order indicated from left to right) on the first DATA LOG Screen.
Page 237 Operating Instructions Chapter 5 Search Book TOC Go Back Predetermined groups of parameters, called Standard Groups, may be selected by pressing the [STANDARD GROUPS] key. Figure 5.40 STANDARD shows the CUSTOMIZE DISPLAY FOR DATA LOG Screen with the GROUPS standard groups displayed. The following soft key labels are displayed when the [STANDARD GROUPS] key is pressed: WBC GROUP RBC GROUP...
Page 238 Chapter 5 Operating Instructions Search Book TOC Go Back CUSTOMIZE PRINTOUT Dec 18 1992 10:31 Ready Operator ID Sequence # 0630 FOR DATA LOG WBC %N %L %M %E %B RBC HGB HCT MCV MCH MCHC RDW PLT MPV UMT1 CNT1 MONO EOS BASO MCH MCHC RDW...
Page 239 Operating Instructions Chapter 5 Search Book TOC Go Back The [PLACE PARAMETER] key is used to display the parameter in the location indicated by the position of the cursor. PLACE PARAMETER The [CANCEL SELECTION] key is used to cancel the selection and display the [SELECT PARAMETER] key.
Page 240: Data Log Codes
Chapter 5 Operating Instructions Search Book TOC Go Back Starting Sequence #: DATA LOG Apr 30 1993 12:58 Ready Operator ID Sequence # 3080 USE < OR > FOR MORE DATA Seq Specimen ID LYM MONO EOS BASO Date Time Op 3037 CD3019A-03 O04/29/93...
Page 241: Data Log Set Up Procedures
Operating Instructions Chapter 5 Search Book TOC Go Back DATA LOG Apr 30 1993 12:57 Ready Operator ID Sequence # 3080 USE < OR > FOR MORE DATA Seq Specimen ID WBC NEU LYM MONO EOS BASO Date Time Op 2621 9100 O04/05/93...
Page 242: Procedure Customize Data Log Display
Chapter 5 Operating Instructions Search Book TOC Go Back CUSTOMIZE DISPLAY Dec 18 1992 10:57 Ready Operator ID Sequence # 0630 FOR DATA LOG Group 1: MONO EOS BASO Group 2: MCH MCHC RDW Group 3: Group 4: MONO EOS BASO MCH MCHC RDW UMT1...
Page 243: Standard Groups
Operating Instructions Chapter 5 Search Book TOC Go Back 3. Use the Arrow keys on the keyboard to move the cursor to the desired parameter in the listing under the matrix. 4. Press [SELECT PARAMETER]. The selected parameter is highlighted and the cursor moves to the first position in Group 1. NOTE: The key label changes to [PLACE PARAMETER] and a [CANCEL SELECTION] key is displayed.
Page 244 Chapter 5 Operating Instructions Search Book TOC Go Back NOTE: This number indicates the order in which the group of parameters will be displayed (Group 1 on the first screen, Group 2 on the second, etc.). 4. Press the soft key corresponding to the desired parameter group. This group is displayed in the position indicated by the cursor.
Page 245 Operating Instructions Chapter 5 Search Book TOC Go Back Customizing the Printout CUSTOMIZE PRINTOUT FOR DATA LOG Screen (see Figure 5.45) 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 246: Data Review From The Data Log
Chapter 5 Operating Instructions Search Book TOC Go Back Data Review from the Data Log Scrolling Through the Data Log The Page Up and Page Down keys may be used to rapidly scroll through the records stored in the Data Log. Press the Page Up key to scroll backward and press the Page Down key to scroll forward.
Page 247: Procedure Record Display
Operating Instructions Chapter 5 Search Book TOC Go Back Procedure Record Display 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 248: Editing A Record
Chapter 5 Operating Instructions Search Book TOC Go Back Editing a Record The Patient Demographics and the Parameter and Patient Limits Sets may be edited for each record. (See Figure 5.47.) Spec ID EDIT SPECIMEN Dec 18 1992 13:11 Patient_____________ Ready Operator ID Sex(M/F):- DOB:--/---/--...
Page 249 Operating Instructions Chapter 5 Search Book TOC Go Back NOTES 5-120 CELL-DYN® 3000 System Operator’s Manual 9140240E — May 1995...
Page 250: References
Chapter 5 Operating Instructions Search Book TOC Go Back 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).
Page 251 Operating Instructions Chapter 5 Search Book TOC Go Back NOTES 5-122 CELL-DYN® 3000 System Operator’s Manual 9140240E — May 1995...
Page 252: Chapter 6. Calibration
Chapter 6 Search Book TOC Go Back Calibration Chapter Table of Contents Introduction ..........6-1 Calibration Materials .
Page 253 Chapter 6 Table of Contents Search Book TOC Go Back Open Mode Procedures ............6-33 Auto-Cal Using The CELL-DYN Calibrator .
Page 254 Chapter 6 Table of Contents Search Book TOC Go Back Mode To Mode Auto-Cal, Closed Sampler Procedure ... 6-70 Procedure ......... . 6-70 Determining Reference Values .
Page 255 Chapter 6 Table of Contents Search Book TOC Go Back NOTES Table of Contents-4 CELL-DYN® 3000 System Operator’s Manual 9140240E — May 1995...
Page 256: Introduction
RBC parameters using Bull’s moving average program (X-B). The calibration of the CELL-DYN 3000 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 257: Calibration Materials
Whole Blood Calibration is given in the next section. • Latex Particles Latex Particles are used to calibrate the Mean Platelet Volume. This function is only used by Abbott Service Representatives. CELL-DYN® 3000 System Operator’s Manual 9140240E — May 1995...
Page 258: General Information
• Open mode • Closed mode — Sample Loader version • Closed mode — Closed Sampler version NOTE: Each CELL-DYN 3000 has only one closed mode of operation. Both the Open and Closed modes must be calibrated individually. For convenience, the Open mode is calibrated first and the Closed mode is then referenced to it.
Page 259: Conventions Used In This Chapter
Calibration Chapter 6 Search Book TOC Go Back Complete instructions for using these criteria and a Calibration Criteria Chart are included with each procedure to facilitate the decision. The chart is depicted in Table 6.1. Table 6.1: Calibration Criteria Chart Validation Range Calibration Range Calibration Limit...
Page 260: Calibration Procedural Summary
Chapter 6 Calibration Search Book TOC Go Back Calibration Procedural Summary Table 6.2: Calibration Procedural Summary Step Choices 1. Read appropriate overview Auto-Cal Calibration Manual Calibration Mode to Mode Calibration 2. Complete Pre-Calibration Procedures 3. Open Mode Calibration Choose ONE: Procedures Auto-Cal Using Commercial Calibrator Auto-Cal Using Fresh Whole Blood*...
Page 261: Whole Blood Calibration Guidelines
Calibration Chapter 6 Search Book TOC Go Back Whole Blood Calibration Guidelines Introduction Calibration with Fresh Whole Blood Samples is an alternative to calibration with a Commercial Calibrator. This section explains the determination of reference values and gives requirements for Whole Blood Samples and calibration with them.
Page 262: Calibration Requirements For Fresh Whole Blood
Reference values 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 3000 with a hemoglobin standard designed for the calibration of specific Reference Cyanmethemoglobin Methods. The instrument uses a Modified Hemiglobincyanide Method which is not designed to analyze these standards directly.
Page 263 3. No more than two hours should elapse between the CELL-DYN 3000 run and the assay by reference methodology. If samples are run on the CELL-DYN 3000 first, assay by reference methodology should be completed within one hour. (Certain reference methodologies are sensitive to RBC swelling caused by in vitro deoxygenation.)
Page 264 Chapter 6 Calibration Search Book TOC Go Back Whole Blood Calibration Reference Values Worksheet Date:___________________________________Parameter:_______________________________________ Technologist:____________________________Method:_________________________________________ ________________________________________________________________________________________ Reference Assays Sample ID Mean Cumulative Parameter Mean CELL-DYN® 3000 System Operator’s Manual 9140240E — May 1995...
Page 265 Calibration Chapter 6 Search Book TOC Go Back NOTES 6-10 CELL-DYN® 3000 System Operator’s Manual 9140240E — May 1995...
Page 266: Calibration Overview
Auto-Cal Overview Introduction The Auto-Cal program provides an automated calibration method that prepares the CELL-DYN 3000 for calibration, calculates new calibration factors and calibrates the instrument. The Auto-Cal program allows calibration with Commercial Calibrators or whole blood samples. Auto- Cal may be performed in the following modes: •...
Page 267: Calibration Requirements For Auto-Cal
Calibration Chapter 6 Search Book TOC Go Back New calibration factors are computed for each parameter by comparing each mean to the reference value entered for that sample. If more than one sample is used, factors are computed for each parameter from each of the samples.
Page 268: Calibration Menu
Chapter 6 Calibration Search Book TOC Go Back Calibration Menu CALIBRATION MENU Screen (Figures 6.1 and 6.2) is accessed from the MAIN MENU Screen by pressing the [CALIBRATION] key. CALIBRA- CALIBRATION MENU Screen displays the current calibration TION factors for the mode indicated, the calibration method used, the date and time the factors were entered and the operator ID.
Page 269: Closed Mode Calibration Factors
Calibration Chapter 6 Search Book TOC Go Back CALIBRATION May 11 1992 10:30 Ready Operator ID Sequence # 4100 Closed Sampler Current Whole Blood Factors: Parameter Method Factor Date Time Operator WHOLE BLOOD 1.056 04/30/92 16:59 WHOLE BLOOD 1.060 04/30/92 16:59 WHOLE BLOOD 1.136...
Page 270 Chapter 6 Calibration Search Book TOC Go Back The [MAIN] key is used to return to the MAIN MENU Screen. MAIN The [ENTER FACTOR] key displays the ENTER WHOLE BLOOD FACTOR Screen showing the current Open and Closed Calibration ENTER Factors (See Figure 6.3).
Page 271 Calibration Chapter 6 Search Book TOC Go Back The [RESET ALL TO 1.00] key is used to reset all of the calibration factors to 1.00. RESET ALL TO 1.00 The [RETURN] key is used to return to the CALIBRATION MENU Screen.
Page 272 To proceed, press the key for the specimen type being used (WHOLE BLOOD, CALIBRATOR, or LATEX). WHOLE CALIBRATR LATEX CHANGE RETURN BLOOD SAMPLER Figure 6.5: Auto-Calibration Screen for CELL-DYN 3000 6-17 CELL-DYN® 3000 System Operator’s Manual 9140240E — May 1995...
Page 273 Calibration Chapter 6 Search Book TOC Go Back The [CHANGE SAMPLER] key is used to change the sample aspiration mode of the Analyzer from the currently selected mode that is CHANGE indicated on the screen. SAMPLER The [RETURN] key is used to return to the CALIBRATION MENU Screen.
Page 274 Chapter 6 Calibration Search Book TOC Go Back WHOLE BLOOD AUTO-CAL May 11 1992 10:01 Operator ID Ready Sequence # 4100 Open Sampler Enter reference value for each parameter to be calibrated: (up to 10 specimens) Spec ID # of runs (1 to 10) (2.0-25.0) (2.00-6.50)
Page 275 Calibration Chapter 6 Search Book TOC Go Back The [START AUTO-CAL] key starts the Auto-Cal program by initiating three background counts. START AUTO-CAL The [CONTINUE AUTO-CAL] key is displayed after the background counts are completed as shown in Figure 6.7. CONTINUE AUTO-CAL NOTE: The key label changes to [INTERRUPT AUTO-CAL]...
Page 276 Chapter 6 Calibration Search Book TOC Go Back WHOLE BLOOD AUTO-CAL May 11 1992 10:01 Ready Operator ID Sequence # 4100 Open Sampler Enter reference value for each parameter to be calibrated: (up to 10 specimens) Spec ID # of runs (1 to 10) (2.0-25.0) (2.00-6.50)
Page 277 Calibration Chapter 6 Search Book TOC Go Back The [REPEAT SPECIMEN] key (see Figure 6.9) is displayed when the first run of the first specimen is completed. This key is used to delete all REPEAT OPEN results (runs) for the current specimen. SAMPLER SPECIMEN NOTE: This key deletes all results for all runs of the current...
Page 278 AUTO-CAL REFERENCE VALUES. The [LATEX] key is used to display the LATEX AUTO-CAL Screen. This screen accesses the Auto-Cal program for MPV calibration with LATEX latex particles which is used by Abbott service personnel. CALIBRATOR AUTO-CAL May 11 1992 10:01...
Page 279: Manual Calibration Overview
Go Back Manual Calibration Overview Introduction The Open mode of the CELL-DYN 3000 may be calibrated without using the Auto-Cal program. CELL-DYN Calibrator or whole blood samples may be used for Manual Calibration. Whole blood samples should meet the requirements outlined in the Whole Blood Calibration section of this chapter.
Page 280: Mode To Mode Calibration Overview
Mode To Mode Calibration Overview Introduction The Open mode of the CELL-DYN 3000 is calibrated with either a commercial calibrator or fresh whole blood samples. The Closed mode is calibrated to match the Open mode using 10 different, fresh, normal whole blood samples.
Page 281: Mode To Mode Calibration Preparation
Calibration Chapter 6 Search Book TOC Go Back Mode to Mode Calibration Preparation 1. Confirm the calibration of the Open mode before calibrating the Closed mode. 2. Select 10 different fresh, whole blood samples that meet the following requirements: • Each sample should have sufficient volume to be run once in the Open mode and twice in the Closed mode.
Page 282: Pre-Calibration Procedures
Chapter 6 Calibration Search Book TOC Go Back Pre-Calibration Procedures Introduction It is advisable to perform calibration at a time when it can be completed without interruption. The Pre-Calibration Procedures in this section verify proper instrument performance to ensure a successful calibration. These steps should be completed just prior to beginning the calibration procedure itself.
Page 283: Instrument Logbook
• Reagent lot number changes • Troubleshooting • Problem resolution • Service calls • Software upgrades This logbook should be stored near the instrument and be accessible to all operators and Abbott Service Personnel. 6-28 CELL-DYN® 3000 System Operator’s Manual 9140240E — May 1995...
Page 284 Chapter 6 Calibration Search Book TOC Go Back CELL-DYN 3000 PRE-CALIBRATION PROCEDURES CHECK LIST Instrument:__________________________________ Date:_____________________________________________ Operator:____________________________________ ________________________________________________________________________________________ ____ 1._______ Perform all required maintenance. 2._______ Verify that all the reagent containers are at least 1/3 full and that the waste container is less than 1/2 full.
Page 285 Calibration Chapter 6 Search Book TOC Go Back 9.______ Verify the Open mode precision by analyzing a fresh, normal whole blood sample 10 times in succession. Run the sample in an empty control file and record the CVs below or attach a file printout to this document.
Page 286 Chapter 6 Calibration Search Book TOC Go Back Problems Detected ________________________________________________________________________________________ ________________________________________________________________________________________ ________________________________________________________________________________________ ________________________________________________________________________________________ ________________________________________________________________________________________ ________________________________________________________________________________________ ________________________________________________________________________________________ ________________________________________________________________________________________ ________________________________________________________________________________________ ________________________________________________________________________________________ ________________________________________________________________________________________ ________________________________________________________________________________________ ________________________________________________________________________________________ ________________________________________________________________________________________ ________________________________________________________________________________________ ________________________________________________________________________________________ ________________________________________________________________________________________ ________________________________________________________________________________________ ________________________________________________________________________________________ ________________________________________________________________________________________ ________________________________________________________________________________________ ________________________________________________________________________________________ ________________________________________________________________________________________ ________________________________________________________________________________________ ________________________________________________________________________________________ ________________________________________________________________________________________ 6-31 CELL-DYN® 3000 System Operator’s Manual 9140240E —...
Page 287 Calibration Chapter 6 Search Book TOC Go Back NOTES 6-32 CELL-DYN® 3000 System Operator’s Manual 9140240E — May 1995...
Page 288: Open Mode Procedures
Chapter 6 Calibration Search Book TOC Go Back Open Mode Procedures Auto-Cal Using The CELL-DYN Calibrator Procedure The calibration procedure has been divided into subsections that consist of a series of easy-to-follow steps. Always follow the entire procedure unless specifically directed to skip to another section. NOTE: Be sure to perform Pre-Calibration procedures and read...
Page 289: Performing The Calibration
Calibration Chapter 6 Search Book TOC Go Back 3. Type the desired number of runs (from 5 to 10) in the <# OF RUNS> field. Press the Enter key on the keyboard to save the entry and advance the cursor. 4.
Page 290 Chapter 6 Calibration Search Book TOC Go Back 7. When the background results are acceptable, press [CONTINUE AUTO-CAL]. 8. Prepare the calibrator for use according to the directions given in the package insert. Be certain to carefully read and follow directions given for warming and mixing.
Page 291: Calibration Factor Calculation
Calibration Chapter 6 Search Book TOC Go Back 10. Consecutively run the Calibrator for the remaining number of runs. Each subsequent run must pass the Reference Check and an additional internal Precision Check. If a run fails either check, the result for that parameter is highlighted and no calibration factor will be calculated for the parameter.
Page 292: Determining Which Parameters Need Calibration
Chapter 6 Calibration Search Book TOC Go Back NOTE: Delete the sign of the Factor % Diff value before entering it on the chart. 3. To determine which parameters require calibration, continue with the next section. Table 6.3: Calibration Criteria Chart Validation Range Calibration Range Calibration Limit...
Page 293 Calibration Chapter 6 Search Book TOC Go Back Press [RETURN]. When the CALIBRATION LOG Screen is displayed, indicate in the <COMMENTS> line that instrument calibration was confirmed and no changes were required. Press the Enter key on the keyboard to save the entry and advance the cursor. Be certain to retain all necessary documentation in the instrument logbook.
Page 294: Calibration For All Parameters
Chapter 6 Calibration Search Book TOC Go Back 3. Calibration Range If the factor % difference falls within the following Calibration Range, calibration is required for that parameter. CALIBRATE THE OPEN MODE as directed in this procedure, either for all parameters or specific parameters.
Page 295: Calibration For Individual Parameters
Calibration Chapter 6 Search Book TOC Go Back Type any comments in the <COMMENTS> field. Press the Enter key on the keyboard to save the entry and advance the cursor. NOTE: Comments may be added to the Calibration Log only after a calibration factor is changed or reentered.
Page 296 Chapter 6 Calibration Search Book TOC Go Back CELL-DYN 3000 Auto-Cal Calibration Worksheet Instrument:______________________________________ Date:________________________________________ Operator:________________________________________ ________________________________________________________________________________________ _______ Auto-Cal Calibration Criteria Factor Validation Range Cal Range Cal Limit Cal? %Diff* Cal Not Required Cal Required Do Not Cal** < <...
Page 297: Auto-Cal Using Whole Blood Samples
Calibration Chapter 6 Search Book TOC Go Back Auto-Cal Using Whole Blood Samples Procedure The calibration procedure has been divided into subsections that consist of a series of easy-to-follow steps. Always follow the entire procedure unless specifically directed to skip to another section. NOTE: Be sure to complete the Pre-Calibration procedures read the...
Page 298: Performing The Calibration
Chapter 6 Calibration Search Book TOC Go Back NOTE: The <# OF RUNS> entered indicates the number of times the sample will be consecutively cycled through the instrument. Each sample may be run a maximum of 10 times. 3. If desired, press [PRINT SUMMARY] to obtain a printout of the reference values.
Page 299 Calibration Chapter 6 Search Book TOC Go Back 8. Run the first whole blood sample one time. The reference value, <VALUE>, and the results of the analysis, <RUN1>, appear on the WHOLE BLOOD AUTO-CAL, RESULTS FOR SPECIMEN (N) screen display. •...
Page 300: Calibration Factor Calculation
Chapter 6 Calibration Search Book TOC Go Back 10. When all runs of a sample have been completed, the bulletin line displays the message: NEW CAL FACTOR COMPUTED. READY FOR NEXT CAL SPECIMEN Press [NEXT SPECIMEN] to run the next sample. Calibration Factor Calculation As each run of a whole blood sample is completed, a Calibration Factor is calculated and updated.
Page 301: Determining Which Parameters Need Calibration
Calibration Chapter 6 Search Book TOC Go Back Table 6.4: Calibration Criteria Chart Validation Range Calibration Range Calibration Limit Cal Not Required Cal Required Do Not Cal <1.5% < >10% >1.5% but <1.0% >10% >1.0% but < <1.0% >10% < >1.0% but <1.0% <...
Page 302 Chapter 6 Calibration Search Book TOC Go Back Be certain to retain all necessary documentation in the instrument logbook. 2. Calibration Limit If the factor % difference for a particular parameter is greater than the following value, there may be an instrument problem, as the value has exceeded the Calibration Limit.
Page 303: Calibration For All Parameters
Calibration Chapter 6 Search Book TOC Go Back Results WITHIN THE FOLLOWING CALIBRATION RANGE: >1.5% but <10% >1.0% but <10% >1.0% but <10% >1.0% but <10% >3.0% but <15% If all parameters require calibration, continue with the following section. If only specific parameters require calibration, skip to the “Calibration for Individual Parameters”...
Page 304: Calibration For Individual Parameters
Chapter 6 Calibration Search Book TOC Go Back NOTE: Comments may be added to the Calibration Log only after a calibration factor is changed or reentered. 6. If desired, press [PRINT LOG] to obtain a printout of the Calibration Log for documentation. Calibration for Individual Parameters If only certain individual parameters require calibration, continue with this section:...
Page 305 Calibration Chapter 6 Search Book TOC Go Back CELL-DYN 3000 Auto-Cal Calibration Worksheet Instrument:______________________________________ Date:________________________________________ Operator:________________________________________ ________________________________________________________________________________________ _______ Auto-Cal Calibration Criteria Factor Validation Range Cal Range Cal Limit Cal? %Diff* Cal Not Required Cal Required Do Not Cal** >10% <...
Page 306: Manual Calibration - Open Mode
Chapter 6 Calibration Search Book TOC Go Back Manual Calibration — Open Mode Procedure The calibration procedure has been divided into subsections that consist of a series of easy-to-follow steps. Always follow the entire procedure unless specifically directed to skip to another section. NOTE: Be sure to complete the Pre-Calibration steps and read...
Page 307: Calibration Factor Calculations
Calibration Chapter 6 Search Book TOC Go Back 9. Press [PRINT QC LOG] to obtain a printout of the data. 10. Press [RETURN] followed by [MAIN] to return to the MAIN MENU Screen. Calibration Factor Calculations 1. Use the mean value for each parameter from the CD MEAN file printout and the Current Open Mode Calibration Factor printout from step 3 (Preparing for Manual Calibration...
Page 308: Determining Which Parameters Need Calibration
Chapter 6 Calibration Search Book TOC Go Back Table 6.5: Calibration Criteria Chart Validation Range Calibration Range Calibration Limit Cal Not Required Cal Required Do Not Cal <1.5% >10% >1.5% but < <1.0% >10% >1.0% but < <1.0% >10% >1.0% but <...
Page 309 Calibration Chapter 6 Search Book TOC Go Back Be certain to retain all necessary documentation in the instrument logbook. 2. Calibration Limit If the factor % difference for a particular parameter is greater than the following value, there may be an instrument problem, as the value has exceeded the Calibration Limit.
Page 310: Calibrating The Open Mode
Chapter 6 Calibration Search Book TOC Go Back Calibrating the Open Mode 1. From the MAIN MENU Screen, press [CALIBRATION]. 2. Press [ENTER FACTOR] to display the ENTER WHOLE BLOOD FACTOR Screen. 3. Type the New Open Mode Calibration Factors for the parameters that require calibration into the appropriate fields in the <OPEN SAMPLER>...
Page 311 Calibration Chapter 6 Search Book TOC Go Back CELL-DYN 3000 Manual Calibration Worksheet Instrument:____________________________________ Date:___________________________________ Operator:______________________________________ ________________________________________________________________________________________ Calculate All Factors To Three Decimal Places New Open Mode Calibration Factors Assay or Ref Mean x Current Open Mode Cal Factor* = New Open Mode Cal Factor...
Page 312 Chapter 6 Calibration Search Book TOC Go Back Factor % Difference New Open Mode Factor - Current Open Mode Factor x 100 = % Diff New Open Mode Factor New Open Mode Current Open New Open Factor Mode Factor* Mode Factor x 100 = %Diff x 100 =...
Page 313 Calibration Chapter 6 Search Book TOC Go Back NOTES 6-58 CELL-DYN® 3000 System Operator’s Manual 9140240E — May 1995...
Page 314: Closed Mode Procedures
Chapter 6 Calibration Search Book TOC Go Back Closed Mode Procedures Mode To Mode Auto-Cal, Sampler Loader Procedure Procedure The calibration procedure has been divided into subsections that consist of a series of easy-to-follow steps. Always follow the entire procedure unless specifically directed to skip to another section.
Page 315: Entering The Reference Values
Calibration Chapter 6 Search Book TOC Go Back 2. From the MAIN MENU Screen, press [CALIBRATION]. 3. If necessary, press [CLOSED SAMPLER] to display the Closed Mode Calibration Factors. 4. If desired, press [PRINT] to obtain a printout of the <CURRENT WHOLE BLOOD FACTORS>...
Page 316: Performing The Calibration
Chapter 6 Calibration Search Book TOC Go Back Performing the Calibration 1. Press [START AUTO-CAL]. The instrument automatically performs three background counts. The screen displays the message: PREPARING ANALYZER FOR CALIBRATION, PLEASE WAIT... on the bulletin line. 2. If the data from the background counts is acceptable, the displayed message changes to: READY TO CALIBRATE.
Page 317 Calibration Chapter 6 Search Book TOC Go Back 9. Press the Start key on the Sample Loader. The Sample Loader will automatically run each sample for the indicated number of runs. 10. When all runs of a sample have been completed, the bulletin line displays the message: NEW CAL FACTOR COMPUTED.
Page 318: Calibration Factor Calculation
Chapter 6 Calibration Search Book TOC Go Back Calibration Factor Calculation As each run of the whole blood samples is completed, a Calibration Factor is calculated and updated. This factor is displayed in the column labeled <SPEC (N) FACTOR>. The column labeled <MEAN FACTOR> contains the average of the calibration factors for all of the whole blood samples used in the calibration.
Page 319: Determining Which Parameters Need Calibration
Calibration Chapter 6 Search Book TOC Go Back Table 6.6: Mode to Mode Calibration Criteria Chart MODE TO MODE CALIBRATION CRITERIA Validation Range Calibration Range Calibration Limit Cal Not Required Cal Required Do Not Cal <1.75% < >10% >1.75% but <1.25% <...
Page 320 Chapter 6 Calibration Search Book TOC Go Back Press [RETURN]. When the CALIBRATION LOG Screen is displayed, indicate in the <COMMENTS> line that instrument calibration was confirmed and no changes were required. Press the Enter key on the keyboard to save the entry and advance the cursor. Be certain to retain all necessary documentation in the instrument logbook.
Page 321: Calibration For All Parameters
Calibration Chapter 6 Search Book TOC Go Back 3. Calibration Range If the factor % difference falls within the following Calibration Range, calibration is required for that parameter. CALIBRATE THE INSTRUMENT as directed in this procedure, either for all parameters or specific parameters. Results WITHIN THE FOLLOWING CALIBRATION RANGE: >1.75% <1...
Page 322: Calibration For Individual Parameters
Chapter 6 Calibration Search Book TOC Go Back 5. Type any comments in the <COMMENTS> field. Press the Enter key on the keyboard to save the entry and advance the cursor. NOTE: Comments may be added to the Calibration Log only after a calibration factor is changed or reentered.
Page 323 Calibration Chapter 6 Search Book TOC Go Back 4. Confirm the calibration of the Closed Mode by running commercial controls as directed in the Post-Calibration Procedures section. 6-68 CELL-DYN® 3000 System Operator’s Manual 9140240E — May 1995...
Page 324 Chapter 6 Calibration Search Book TOC Go Back CELL-DYN 3000 Mode to Mode Calibration Worksheet Instrument:__________________________________ Date:______________________________________ Operator:______________________________________ ________________________________________________________________________________________ Mode to Mode Calibration Criteria Factor Validation Range Cal Range Cal Limit Cal? %Diff* Cal Not Required Cal Required Do Not Cal** <1.75%...
Page 325: Mode To Mode Auto-Cal, Closed Sampler Procedure
Calibration Chapter 6 Search Book TOC Go Back Mode To Mode Auto-Cal, Closed Sampler Procedure Procedure The calibration procedure has been divided into subsections that consist of a series of easy-to-follow steps. Always follow the entire procedure unless specifically directed to skip to another section. Confirm the calibration of the Open mode before performing this procedure.
Page 326: Entering The Reference Values
Chapter 6 Calibration Search Book TOC Go Back 3. If necessary, press [CLOSED SAMPLER] to display the Closed Mode Calibration Factors. 4. If desired, press [PRINT] to obtain a printout of the <CURRENT WHOLE BLOOD FACTORS> displayed on the screen. NOTE: These calibration factors are retained in the Auto-Cal Calibration Log...
Page 327: Performing The Calibration
Calibration Chapter 6 Search Book TOC Go Back Performing the Calibration 1. Press [START AUTO-CAL]. The instrument automatically performs three background counts. The screen displays the message: PREPARING ANALYZER FOR CALIBRATION, PLEASE WAIT... on the bulletin line. 2. If the data from the background counts is acceptable, the displayed message changes to: READY TO CALIBRATE.
Page 328 Chapter 6 Calibration Search Book TOC Go Back • If the first run passes this internal Reference Check, proceed to step • If the first run fails the Reference Check for any parameter, the results are highlighted and the bulletin line displays the message: THIS RESULT IS OUTSIDE THE ALLOWED LIMITS.
Page 329: Calibration Factor Calculation
Calibration Chapter 6 Search Book TOC Go Back Calibration Factor Calculation As each run of the whole blood samples is completed, a Calibration Factor is calculated and updated. This factor is displayed in the column labeled <SPEC (N) FACTOR>. The column labeled <MEAN FACTOR> contains the average of the calibration factors for all of the whole blood samples used in the calibration.
Page 330: Determining Which Parameters Need Calibration
Chapter 6 Calibration Search Book TOC Go Back Table 6.7: Mode to Mode Calibration Criteria Chart Mode to Mode Calibration Criteria Validation Range Calibration Range Calibration Limit Cal Not Required Cal Required Do Not Cal <1.75% >10% < >1.75% but <1.25% >10% <...
Page 331 Calibration Chapter 6 Search Book TOC Go Back Press [RETURN]. When the CALIBRATION LOG Screen is displayed, indicate in the <COMMENTS> line that instrument calibration was confirmed and no changes were required. Press the Enter key on the keyboard to save the entry and advance the cursor. Be certain to retain all necessary documentation in the instrument logbook.
Page 332: Calibration For All Parameters
Chapter 6 Calibration Search Book TOC Go Back 3. Calibration Range If the factor % difference falls within the following Calibration Range, calibration is required for that parameter. CALIBRATE THE CLOSED MODE as directed in this procedure, either for all parameters or specific parameters.
Page 333: Calibration For Individual Parameters
Calibration Chapter 6 Search Book TOC Go Back 5. Type any comments in the <COMMENTS> field. Press the Enter key on the keyboard to save the entry and advance the cursor. Comments may be added to the Calibration Log only after a calibration factor is changed or reentered.
Page 334 Chapter 6 Calibration Search Book TOC Go Back 3. Retain all necessary documentation in the instrument logbook. 4. Confirm the calibration of the Closed mode by running commercial controls as directed in the Post-Calibration Procedures section. 6-79 CELL-DYN® 3000 System Operator’s Manual 9140240E —...
Page 335 Calibration Chapter 6 Search Book TOC Go Back CELL-DYN 3000 Mode to Mode Calibration Worksheet Instrument:__________________________________ Date:______________________________________ Operator:______________________________________ ________________________________________________________________________________________ Mode to Mode Calibration Criteria Factor Validation Range Cal Range Cal Limit Cal? %Diff* Cal Not Required Cal Required Do Not Cal** <1.75%...
Page 336: Manual Mode To Mode Calibration
Chapter 6 Calibration Search Book TOC Go Back Manual Mode To Mode Calibration Procedure The calibration procedure has been divided into subsections that consist of a series of easy-to-follow steps. Always follow the entire procedure unless specifically directed to skip to another section. Confirm the calibration of the Open mode before performing this procedure.
Page 337: Determining The Closed Mode Mean
Calibration Chapter 6 Search Book TOC Go Back 10. Press [RETURN] followed by [MAIN] to return to the MAIN MENU Screen. Determining the Closed Mode Mean 1. From the MAIN MENU Screen, press [RUN]. 2. Press [CHANGE SAMPLER] to select the Closed mode. 3.
Page 338: Determining Which Parameters Need Calibration
Chapter 6 Calibration Search Book TOC Go Back Table 6.8: Mode to Mode Calibration Criteria Chart Mode to Mode Calibration Criteria Validation Range Calibration Range Calibration Limit Cal Not Required Cal Required Do Not Cal <1.75% >10% >1.75% but < <1.25% <...
Page 339 Calibration Chapter 6 Search Book TOC Go Back When the CALIBRATION LOG Screen is displayed, indicate in the <COMMENTS> line that instrument calibration was confirmed and no changes were required. Press the Enter key on the keyboard to save the entry and advance the cursor. Be certain to retain all necessary documentation in the instrument logbook.
Page 340: Calibration Factor Calculation
Chapter 6 Calibration Search Book TOC Go Back Results WITHIN THE FOLLOWING CALIBRATION RANGE: >1.75% but <1 >1.25% but <1 >1.25% but <1 >1.25% but <1 >3.50% but < Calibration Factor Calculation 1. Use the appropriate worksheet to calculate the New Closed Mode Calibration Factor for the parameters that require calibration as follows: (Use the Current Closed Mode Cal Factor printed at the start of this procedure.)
Page 341: Completing Mode To Mode Calibration
Calibration Chapter 6 Search Book TOC Go Back 5. The CALIBRATION LOG Screen is automatically displayed. The log holds 10 entries. (The screen displays five entries. Display the other five by pressing the Page Up key on the keyboard.) When the log is full, subsequent entries cause the oldest entry to be deleted and the remaining entries to move up one line so that the current factors are added to the bottom of the list.
Page 342 Chapter 6 Calibration Search Book TOC Go Back CELL-DYN 3000 Manual Calibration Worksheet Instrument:____________________________________ Date:___________________________________ Operator:______________________________________ ________________________________________________________________________________________ Calculate All Factors To Three Decimal Places Mode to Mode Calibration Difference Closed Mode Mean - Open Mode Mean x 100 = % Diff...
Page 343 Calibration Chapter 6 Search Book TOC Go Back New Closed Mode Calibration Factors Open Mode Mean x Current Closed Mode Cal Factor* = New Closed Mode Cal Factor Closed Mode Mean Closed Current Closed Open Mode Mode Closed Mode Mode Cal Mean Mean Cal Factor*...
Page 344: Post-Calibration Procedures
3. Include documentation as to the resolution of the problem in the instrument logbook. Calibration Back-Up The current calibration factors should be saved on the CELL-DYN 3000 Set-Up Disk whenever calibration is changed. Data should also be saved whenever any Set-Up information is changed and after any service work is performed.
Page 345 Calibration Chapter 6 Search Book TOC Go Back • Analyzer Module Set Points (e.g., gains, dil factors [internal calibration factors], thresholds, pressure/vacuum settings) • RBC Editing Ratio To back up the calibration factors, proceed as follows: 1. Turn the Data Station power switch OFF. 2.
Page 346: References
Chapter 6 Calibration Search Book TOC Go Back 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).
Page 347 Calibration Chapter 6 Search Book TOC Go Back NOTES 6-92 CELL-DYN® 3000 System Operator’s Manual 9140240E — May 1995...
Page 348: Chapter 7. Quality Control
Introduction ........7-15 CELL-DYN 3000 Westgard Rules ..... . . 7-15 Rule Violations .
Page 349 Chapter 7 Table of Contents Search Book TOC Go Back NOTES Table of Contents-2 CELL-DYN® 3000 System Operator’s Manual 9140240E — May 1995...
Page 350 Chapter 7 Search Book TOC Go Back Quality Control Introduction The CELL-DYN® 3000 offers several quality control options to monitor and validate instrument performance. The options are: X-B Analysis—Bull’s moving average program applied to the RBC indices 20 QC Files—Statistical and graphical analysis of the data in each file to calculate the mean, standard deviation and coefficient of variation Westgard Rules—A multi-rule system applied to the data in each...
Page 351 Quality Control Chapter 7 Search Book TOC Go Back NOTES CELL-DYN® 3000 System Operator’s Manual 9140240E — May 1995...
Page 352: Quality Control Menu
Chapter 7 Quality Control Search Book TOC Go Back Quality Control Menu This section discusses the options available when the [QC LOGS] key on the MAIN MENU is pressed. The options used to set up the QC files are available from the QC MENU (see Figure...
Page 353: Figure 7.1: Qc Menu Screen
Quality Control Chapter 7 Search Book TOC Go Back QC MENU Mar 13 1993 15:51 Operator ID Ready Sequence # 0525 File Name # Specimens File Name # Specimens L0058A 11. PATIENT N0058A 12. FILE 12 13. FILE 13 H0058A 14.
Page 354 Chapter 7 Quality Control Search Book TOC Go Back X-B DISPLAY Mar 12 1993 14:28 Operator ID Uninitialized Sequence # 2368 Batch MCHC DATE TIME Batch MCV MCHC DATE TIME 90.36 30.34 33.70 10/17/92 13:35 89.84 29.52 32.79 12/10/92 10:38 90.23 30.34 33.82...
Page 355 Quality Control Chapter 7 Search Book TOC Go Back X-B DISPLAY Dec 22 1992 14:40 Ready Operator ID PAGE UP/DN FOR MORE DATA Sequence # 0630 MCHC 94.50 31.50 35.70 90.00 30.00 34.00 85.50 28.50 32.30 SHOW PRINT RETURN DATA Figure 7.3: The X-B Display Screen (Graph) The [PRINT] key is used to print the X-B data or graphs.
Page 356 Chapter 7 Quality Control Search Book TOC Go Back 09:56 Lot Number: 2345 Mar 15 1993 VIEW QC LOG Operator ID Exp. Date: 04/01/93 Ready Sequence # N0058A: 90/120 USE < OR > FOR MORE DATA 2723 Page 9 of 9 Upper Limits: 4.58 13.8...
Page 357 Quality Control Chapter 7 Search Book TOC Go Back 4. The remainder of the screen displays the file information and the data. The upper and lower limits entered are displayed immediately above the parameter names. The sequence number for each result is displayed to the left of the data.
Page 358 Chapter 7 Quality Control Search Book TOC Go Back 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 PURGE labels are displayed: QC LOG CONFIRM PURGE CANCEL PURGE...
Page 359 Quality Control Chapter 7 Search Book TOC Go Back Each of these keys is used to select the graphs for a group of data that correspond to the groups selected in the customize QC display option. GROUP Subsequent groups may be selected by pressing the appropriate soft keys. 1 - 4 NOTE: The soft key for the group currently shown on the screen is not displayed.
Page 360 Chapter 7 Quality Control Search Book TOC Go Back When the key is pressed, the key label changes to [ACCEPT SPECIMEN], an “R” is displayed in the column immediately left of the results and the statistics are recomputed excluding those results. (See Figure 7.6.) The data is still displayed and stored in the file but is excluded from the statistical calculation.
Page 361 Quality Control Chapter 7 Search Book TOC Go Back The feature enabling the transfer of QC limits and data from a QC file onto a floppy disk is not currently available. Therefore the following WRITE QC keys mentioned in this manual should not be used at this time: [LAB ID TO DISK SETUP], [LOAD FROM DISK], and [WRITE QC TO DISK].
Page 362: Quality Control Guide
The first section of this guide gives information about running controls and guidelines for basic assay verification. The section on Westgard Rules defines the rules used on the CELL-DYN 3000 and gives guidance for their application in the hematology laboratory. X-B analysis discussed in detail in the last section.
Page 363: Assay Verification
Quality Control Chapter 7 Search Book TOC Go Back • Store the controls at recommended temperatures. Storage in a central location in the refrigerator, away from the door if it is opened frequently, is advisable. • Carefully warm and resuspend the product according to the directions given in the package insert.
Page 364: Westgard Rules
Introduction A control rule tests the control result against control limits to determine whether the CELL-DYN 3000 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.
Page 365: Westgard Rule Violations
Quality Control Chapter 7 Search Book TOC Go Back Rule 5 (4 Four consecutive values outside same 1SD Four consecutive results fell outside 1SD on the same side of the mean Rule 6 (10x): Ten consecutive values on the same side of mean Ten consecutive results fell on the same side of the mean The rules may be used singly or in combination depending on operator...
Page 366 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 Customer Support Center for assistance at 1 (800) CELL DYN.
Page 367: X-B Analysis
The X-B algorithm provides a means of utilizing this information for quality control on the CELL-DYN 3000. 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 368: Target Value
Chapter 7 Quality Control Search Book TOC Go Back Target Value The target value for X-B is similar to the assay value for a commercial control. It is derived from the patient population analyzed on the instrument. Action Limit The action limit is the acceptable limit of variation around the target value.
Page 369 Quality Control Chapter 7 Search Book TOC Go Back NOTES 7-20 CELL-DYN® 3000 System Operator’s Manual 9140240E — May 1995...
Page 370: References
Chapter 7 Quality Control Search Book TOC Go Back 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 multi-rule control chart for the quality control of PT and APTT analyses.
Page 371 Quality Control Chapter 7 Search Book TOC Go Back NOTES 7-22 CELL-DYN® 3000 System Operator’s Manual 9140240E — May 1995...
Page 372: Chapter 8. Precautions, Limitations And Hazards
Chapter 8 Search Book TOC Go Back Precautions, Limitations and Hazards Chapter Table of Contents Limitations ..........8-1 Location Requirements .
Page 373 Chapter 8 Table of Contents Search Book TOC Go Back NOTES Table of Contents-2 CELL-DYN® 3000 System Operator’s Manual 9140240E — May 1995...
Page 374: Limitations
Location Requirements • An authorized Abbott representative must install the instrument. • Place the CELL-DYN 3000 Analyzer and Data Station on a hard, level surface. The location should have nonporous, non-absorbing work surfaces and flooring which can be easily cleaned and disinfected using recommended procedures.
Page 375: Electrical Safety Precautions
Precautions, Limitations and Hazards Chapter 8 Search Book TOC Go Back • The following space should be available to ensure proper ventilation: • Behind the Analyzer and Data Station: 6" (15 cm) • Left of the Analyzer: 6" (15 cm) •...
Page 376: Mechanical Safety Precautions
Chemical Safety Precautions Exposure to potential hazards of chemicals used in the operation and maintenance of the CELL-DYN 3000 should be prevented by the use of information on material safety data sheets (MSDS) and proper personal protective equipment, work procedures, and equipment as specified on the OSHA Hazard Communication Standard (29 CFR Part 1910.1200).
Page 377: Decontamination Procedures
Precautions, Limitations and Hazards Chapter 8 Search Book TOC Go Back Decontamination Procedures • Perform the Auto-Clean procedure. This procedure flushes all of the fluid pathways with reagents to purge any waste from the fluid pathways. (The open sample aspiration probe and the SL or CS needles are automatically rinsed after every cycle.) The surfaces of the instrument should be wiped with a nonabrasive detergent solution to remove any soiling.
Page 378: Reagent Storage And Handling
Chapter 8 Precautions, Limitations and Hazards Search Book TOC Go Back Reagent Storage and Handling • Store reagents, calibrators and controls according to the directions in the package inserts that accompany them. • Protect reagents from extreme heat and freezing during storage. Temperatures below 32°F (0°C) may cause layering that changes the tonicity and conductivity of the reagent.
Page 379: Sample Loader Precautions
Precautions, Limitations and Hazards Chapter 8 Search Book TOC Go Back Sample Loader Precautions • Samples that will be run on the Sample Loader should be collected in 13 x 75 mm tubes. The recommended tube is a 13 x 75 mm tube with a hemoguard closure that draws 3 mL of blood.
Page 380: Chapter 9. Maintenance
Chapter 9 Search Book TOC Go Back Maintenance Chapter Table of Contents Introduction ..........9-1 Preventive Maintenance Schedule .
Page 381 Chapter 9 Table of Contents Search Book TOC Go Back As Required ...............9-35 As Required Maintenance .
Page 382 Many required preventive maintenance procedures have been automated on the CELL-DYN 3000. These programs can be accessed by pressing the [SPECIAL PROTOCOLS] key on the Data Station. The SPECIAL PROTOCOLS MENU is discussed in the next section.
Page 383 Go Back The maintenance schedule outlined on the following page will minimize operational problems with the CELL-DYN 3000. The recommended intervals are based on instruments operating in laboratories that process samples from a general patient population. The intervals are affected by the volume of samples processed, the workload schedule, the operating environment and the patient population that is analyzed.
Page 384: Preventive Maintenance Schedule
Chapter 9 Maintenance Search Book TOC Go Back Preventive Maintenance Schedule The following procedures should be performed at the scheduled time intervals or as determined by each individual lab: Daily 1. Perform the Auto Clean procedure 2. Clean the SL or CS Needle Weekly 1.
Page 385: Special Procedures
Maintenance Chapter 9 Search Book TOC Go Back Special Procedures 1. Closed sampler tube retainer adjustment 2. Clean for shipping WARNING: Potential Biohazard. Follow established biosafety practices when performing maintenance, service or troubleshooting procedures. Wear gloves, lab coat, and suitable eye protection.
Page 386 WBC Flow Optical Cell Cover Bench Assembly Status Vent Mixing Sample Aspiration Indicator Accumulator Chamber Peristaltic Pump Panel Mixing Chamber READY BUSY Shear Valve Assembly FAULT WBC Transfer Flow Cell Peristaltic Pump Wash Block RBC/PLT Waste Transducer Chamber 1 Assembly Hydrophobic Filters Waste...
Page 387 Maintenance Chapter 9 Search Book TOC Go Back NOTES CELL-DYN® 3000 System Operator’s Manual 9140240E — May 1995...
Page 388: Special Protocols Menu
Chapter 9 Maintenance Search Book TOC Go Back Special Protocols Menu SPECIAL PROTOCOLS Screen (Figure 9.2) is accessed from the MAIN MENU Screen by pressing the [SPECIAL PROTOCOLS] key. SPECIAL The following soft key labels are displayed: PROTOCOLS EMPTY RBC FILL RBC (Key label alternates between these two selections.)
Page 389: Figure 9.2: Special Protocols Screen
Maintenance Chapter 9 Search Book TOC Go Back SPECIAL PROTOCOLS May 15 1993 10:01 Operator ID Ready Sequence # 2723 EMPTY EMPTY EMPTY CLEAN DISABLE MORE MAIN REAG RESV SHEAR VAL ANALYZER Figure 9.2: Special Protocols Screen A brief description of the function of each soft key follows. Detailed instructions for the use of each key are given in the appropriate maintenance procedure.
Page 390 Chapter 9 Maintenance Search Book TOC Go Back The [EMPTY WBC] key is used to drain the Sheath from the WBC flow cell. When the flow cell is empty, the key label changes to [FLUSH EMPTY SHEATH]. The display in the Status Box reads: Not Ready: See SPECIAL When the [FLUSH SHEATH] key is pressed, the flow cell is refilled with Sheath.
Page 391 Maintenance Chapter 9 Search Book TOC Go Back 12:10 SPECIAL PROTOCOLS Mar 11 1993 Operator ID Ready Sequence # 4249 FLUSH AUTO DAILY PREPARE CLEAN EXTEND MORE MAIN SHEATH CLEAN SHUTDOWN SHIPPING NEEDLE AUTOCLEAN Figure 9.3: Special Protocols Screen 2 The [FLUSH SHEATH] key is used to flush the WBC flow cell with Sheath reagent.
Page 392 Chapter 9 Maintenance Search Book TOC Go Back WARNING: Potential Biohazard. Follow established biosafety practices when performing maintenance, service or troubleshooting procedures. Wear gloves, lab coat, and suitable eye protection. Refer to Chapter 8, Precautions, Limitations and Hazards, for additional information. NOTE: Once Auto-Clean is initiated, it cannot be stopped by the operator.
Page 393 Maintenance Chapter 9 Search Book TOC Go Back The [MORE] key is used to return to the first SPECIAL PROTOCOLS Screen. MORE After certain Special Protocols, the following screen is displayed. SPECIAL PROTOCOLS Sep 14 1994 16:20 Initialized Operator ID Sequence # 3288 Special Protocol Cycle has completed.
Page 394: Daily
Chapter 9 Maintenance Search Book TOC Go Back Daily Daily Maintenance Procedures NOTE: After performing maintenance procedures, the Auto-Clean procedure should be performed. Auto-Clean The Auto-Clean procedure is a fully automated procedure designed to clean the shear valve, the WBC mixing chamber, the WBC flow cell, the HGB mixing chamber, the HGB flow cell, the RBC/PLT transducer assembly, the needle in the CS or SL version and all the associated fluidics.
Page 395 Maintenance Chapter 9 Search Book TOC Go Back CAUTION: Use powder-free gloves when performing the maintenance procedure to avoid contaminating the instrument. Materials Required 1. CELL-DYN Enzymatic Cleaner (brought to room temperature) 2. Clean test tube or container 3. Lint-free wipes or gauze 4.
Page 396: Sample Loader Aspiration Needle
Chapter 9 Maintenance Search Book TOC Go Back 9. Verify that the background counts are acceptable by running 5 background counts before running controls. If the background counts or controls are unacceptable, refer to Chapter 10, Troubleshooting. Sample Loader Aspiration Needle The aspiration needle on the Sample Loader version of the CELL-DYN 3000 should be cleaned regularly to remove protein buildup or debris and reduce the possibility of a blockage.
Page 397: Closed Sampler Aspiration Needle
Maintenance Chapter 9 Search Book TOC Go Back Closed Sampler Aspiration Needle The aspiration needle on the closed sampler version of the CELL-DYN 3000 should be cleaned regularly to remove protein buildup or debris and reduce the possibility of a blockage. Materials Required 1.
Page 398: Weekly
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 3000 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 399: Figure 9.6: Shear Valve Assembly
Maintenance Chapter 9 Search Book TOC Go Back Rear Section Center Section Front Section Retaining Screw Shear Valve Mounting Guide Lock Notch Rim Notch Figure 9.6: Shear Valve Assembly Materials Required 1. Shear valve lubricant 2. Nonabrasive, lint-free wipes 3. A container of warm water 4.
Page 400 Chapter 9 Maintenance Search Book TOC Go Back 4. Grasp the entire valve assembly firmly and pull it away from the Analyzer with a slight rocking motion until it is free of the mounting guide. NOTE: If the O-ring, and/or plastic bushing are accidentally removed with the shear valve, replace them at this time.
Page 401: Aspiration Peristaltic Pump Tubing
The tubing in the aspiration peristaltic pump needs to be replaced on a regular basis to ensure proper fluid movement through the instrument. The frequency of replacement depends on instrument use in each laboratory. Abbott recommends changing the aspiration pump tubing weekly. A peristaltic pump is depicted in Figure 9.7.
Page 402: Figure 9.7: Aspiration Peristaltic Pump
Chapter 9 Maintenance Search Book TOC Go Back Rollers Metal Bracket Metal Bracket Collar Collar Pump Release Lever Tubing Figure 9.7: Aspiration Peristaltic Pump Materials Required 1. Sample aspiration peristaltic pump tubing 2. Gloves, lab coat, and suitable eye protection WARNING: Potential Biohazard.
Page 403: Sample Loader Tray, Racks And Safety Cover
Maintenance Chapter 9 Search Book TOC Go Back Procedure 1. From the SPECIAL PROTOCOLS Screen, press [DISABLE ANALYZER]. 2. Remove the upper front cover to gain access to the peristaltic pumps. 3. Locate the sample aspiration pump to the left of the shear valve. (See Figure 9.1.)
Page 404 Chapter 9 Maintenance Search Book TOC Go Back WARNING: Potential Biohazard. Follow established biosafety practices when performing maintenance, service or troubleshooting procedures. Wear gloves, lab coat, and suitable eye protection. Refer to Chapter 8, Precautions, Limitations and Hazards, for additional information. CAUTION: Use powder-free gloves when performing the maintenance procedure to avoid contaminating the instrument.
Page 405 Maintenance Chapter 9 Search Book TOC Go Back NOTES 9-24 CELL-DYN® 3000 System Operator’s Manual 9140240E — May 1995...
Page 406: Monthly
Chapter 9 Maintenance Search Book TOC Go Back Monthly Monthly Maintenance Procedures Reagent Syringes The reagent syringes need to be cleaned on a regular basis to prevent reagent residue buildup, which may cause leakage or improper functioning. Syringes should be cleaned one at a time to ensure that each syringe is replaced in the correct position.
Page 407 Maintenance Chapter 9 Search Book TOC Go Back WARNING: Potential Biohazard. Follow established biosafety practices when performing maintenance, service or troubleshooting procedures. Wear gloves, lab coat, and suitable eye protection. Refer to Chapter 8, Precautions, Limitations and Hazards, for additional information. CAUTION: Use powder-free gloves when performing the maintenance procedure to avoid contaminating the instrument.
Page 408 Chapter 9 Maintenance Search Book TOC Go Back 9. Refill the syringe with the appropriate reagent (refer to Figure 9.1) to the level noted in step 4 above. Hold the syringe upright and tap the side gently to dislodge any bubbles that may adhere to the tip of the plunger and dispense the bubbles.
Page 409: Wbc Transfer Peristaltic Pump Tubing
WBC flow cell. The frequency of replacement depends on instrument use in each laboratory. Abbott recommends changing the WBC pump tubing monthly. A peristaltic pump is depicted in the following figure.
Page 410 Chapter 9 Maintenance Search Book TOC Go Back CAUTION: Use powder-free gloves when performing the maintenance procedure to avoid contaminating the instrument. NOTE: The sample aspiration pump tubing has a smaller diameter than the WBC transfer pump tubing and is identified by the orange collar on each end.
Page 411: Air Filters
Maintenance Chapter 9 Search Book TOC Go Back Inlet Filters Figure 9.10: Analyzer Left Side Panel Materials Required 1. Running water 2. Lint-free wipes or towels 3. Small vacuum cleaner (optional) 4. Gloves, lab coat, and suitable eye protection Analyzer Filter Procedure 1.
Page 412: Figure 9.11: Data Station Rear Panel
Chapter 9 Maintenance Search Book TOC Go Back Data Station Filter Procedure 1. Locate the fan filter on the rear of the Data Station, if present. (See Figure 9.11.) 2. The plastic frame that holds the filter in place snaps onto the bracket that holds the fan.
Page 413: Extended Auto-Clean
Maintenance Chapter 9 Search Book TOC Go Back Extended Auto-Clean The Extended Auto-Clean procedure is a fully automated procedure designed to clean the shear valve, the WBC mixing chamber, the WBC flow cell, the HGB mixing chamber, the HGB flow cell, the RBC/PLT transducer assembly, the needle in the CS or SL version and all the associated fluidics.
Page 414: Figure 9.12: Special Protocols: Extended Auto-Clean Screen
Chapter 9 Maintenance Search Book TOC Go Back SPECIAL PROTOCOLS Nov 091992 12:25 Operator ID Ready Sequence # 0630 Hold a bottle of Cell-Dyn Enzymatic Cleaner under the probe, and press the START key When the Extended Auto-Clean process is completed, the instrument will automatically go to STANDBY.
Page 415 Maintenance Chapter 9 Search Book TOC Go Back 7. Press [START]. 8. Continue to hold the container under the probe until a beep tone is heard. Remove the container and discard the remaining enzymatic cleaner. NOTE: The complete procedure takes 2.5 hours but may be terminated after 38 minutes by pressing the [CANCEL] key.
Page 416: As Required
Chapter 9 Maintenance Search Book TOC Go Back As Required As Required Maintenance RBC/PLT Aperture Plate The RBC/PLT aperture plate is automatically cleaned during the Auto-Clean procedure. However, occasionally it may be necessary to remove the aperture plate for cleaning. Refer to the instrument logbook to find the latest baseline count time.
Page 417: Procedure
Maintenance Chapter 9 Search Book TOC Go Back Materials Required 1. Cleaning solutions: Either of the following solutions may be used to clean the aperture plate. Each solution should be prepared fresh just before use, as it will deteriorate over time. a.
Page 418: Figure 9.14: Transducer Assembly And Aperture Plate
Chapter 9 Maintenance Search Book TOC Go Back 5. Pull the red release lever located in front of the transducer out and to the right to release the aperture plate. (See Figure 9.14.) Counting Chamber Mixing Chamber Aperture Plate Release Lever Figure 9.14: Transducer Assembly and Aperture Plate...
Page 419 Maintenance Chapter 9 Search Book TOC Go Back 8. When the plate is clean, remove it from the cleaning solution and thoroughly rinse it with a stream of deionized water. Do not dry the aperture plate. 9. Insert the plate between the transducer chambers with the orientation notch on the bottom leading edge.
Page 420 NOTE: This is not a routine cleaning/maintenance procedure. It should be performed only if routine methods fail or at the request of the Abbott Customer Support Center. Under normal circumstances, the Auto-Clean procedure is sufficient to ensure the cleanliness of the HGB flow cell. If the Auto-Clean procedure fails to adequately clean the flow cell, this procedure may be used.
Page 421 Maintenance Chapter 9 Search Book TOC Go Back CAUTION: Use powder-free gloves when performing the maintenance procedure to avoid contaminating the instrument. Procedure 1. Press [SPECIAL PROTOCOLS] followed by [DISABLE ANALYZER] to disable the Analyzer. 2. Remove the front covers to gain access to the HGB mixing chamber and HGB flow cell assembly.
Page 422: Vacuum Accumulator Cleaning Procedure
Chapter 9 Maintenance Search Book TOC Go Back Vacuum Accumulator Cleaning Procedure Materials Needed 1. Large syringe (50/60 mL) 2. 400 mL of distilled water 3. Empty receptacle 4. Hemostat or clamp 5. Gloves, lab coat, and suitable eye protection WARNING: Potential Biohazard.
Page 423 Maintenance Chapter 9 Search Book TOC Go Back 8. Replace the white caps on the line. 9. Repeat Steps 4 through 8 with the other drain line. 10. Replace the upper and lower front covers on the Analyzer. 11. Power ON the Analyzer and then power ON the Data Station. 12.
Page 424: Special Procedures
Chapter 9 Maintenance Search Book TOC Go Back Special Procedures Closed Sampler Tube Retainer Adjustment It is necessary to adjust the tube retainer on the CELL-DYN 3000CS to accommodate different sized Vacutainer® tubes. The closed sampler module is depicted in Figure 9.16. Release Levers Tube (One on each side)
Page 425: Preparation For Inactivity Or Shipping
Maintenance Chapter 9 Search Book TOC Go Back Preparation for Inactivity or Shipping The Prepare For Shipping Procedure must be performed if the instrument will not be used for two weeks or more. This procedure must also be performed prior to shipping the instrument or relocating it. Salt deposits and reagent residue may clog the flow system if they are not removed prior to a period of inactivity or shipment.
Page 426 Chapter 9 Maintenance Search Book TOC Go Back 4. When the process is complete turn OFF the power to Analyzer, Data Station, and Sample Loader (if CELL-DYN 3000SL). 5. Carefully remove the reagent inlet tubes from the normally closed valves under the reagent reservoirs located on the left side panel of the Analyzer.
Page 427: Repackaging For Shipment
Hazards, for additional information. Repackaging for Shipment When the CELL-DYN 3000 is to be shipped and the original packaging is available, repackage the instrument as it was originally shipped. When the instrument is to be shipped and the original packaging is unavailable, call the Customer Support Center for assistance with repackaging the unit for shipment at 1 (800) CELL DYN.
Page 428: Chapter 10. Troubleshooting
Chapter 10 Search Book TOC Go Back Troubleshooting Chapter Table of Contents Introduction ..........10-1 Diagnostics Menu .
Page 429 Chapter 10 Table of Contents Search Book TOC Go Back NOTES Table of Contents-2 CELL-DYN® 3000 System Operator’s Manual 9140240E — May 1995...
Page 430: Introduction
Troubleshooting Guide is designed to assist the operator in identifying and resolving instrument problems. Instructions are also given for obtaining technical assistance from the Abbott Customer Support Center. The guide includes troubleshooting procedures, instructions for component replacement and troubleshooting tips and techniques.
Page 431 Troubleshooting Chapter 10 Search Book TOC Go Back NOTES 10-2 CELL-DYN® 3000 System Operator’s Manual 9140240E — May 1995...
Page 432: Diagnostics Menu
Chapter 10 Troubleshooting Search Book TOC Go Back Diagnostics Menu This section 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 433: Diagnostics
Troubleshooting Chapter 10 Search Book TOC Go Back Diagnostics 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 PRINT...
Page 434 Chapter 10 Troubleshooting Search Book TOC Go Back When the [FAULT REPORT] key is pressed, information regarding the pending fault is displayed on the screen. The screen displays the words FAULT OPERATOR CORRECTABLE FAULT REPORT: (see Figure 10.2) REPORT FATAL FAULT REPORT: (see Figure 10.3) and any additional...
Page 435 Troubleshooting Chapter 10 Search Book TOC Go Back DIAGNOSTICS MENU Jan 20 1993 12:20 Fault: See DIAG Operator ID Sequence # 2713 Fatal fault report : RBC diluent syringe overpressure RBC diluent syringe overpressure FAULT EXECUTION CNT RATE CLEAR RAW DATA MORE PRINT MAIN...
Page 436 Chapter 10 Troubleshooting Search Book TOC Go Back DIAGNOSTICS MENU Jan 20 1993 15:58 Operator ID Ready Sequence # 1917 No fault pending FAULT EXECUTION CNT RATE CLEAR RAW DATA MORE PRINT MAIN REPORT TIMES SUMMARY FAULTS SUMMARY Figure 10.4: Fault Report –...
Page 437 Troubleshooting Chapter 10 Search Book TOC Go Back DIAGNOSTICS MENU Jan 20 1993 12:29 Ready Operator ID Sequence # 2715 PLT: 767 Max % diff WBC: 311 RBC: 295 PRINT RETURN CNT RATE CNT RATE CNT RATE Figure 10.5: Count Rate Summary Screen Each key displays kinetic data for the selected parameter from the last cycle run.
Page 438 Chapter 10 Troubleshooting Search Book TOC Go Back DIAGNOSTICS MENU Jan 20 1993 12:30 Operator ID Ready Sequence # 2716 WBC : TOTAL COUNT: 5934 TIME: 0.50 1.05 1.55 2.07 2.57 3.08 3.62 4.12 COUNT: 1183 1576 1989 2359 2799 3225 RATE: 714.85...
Page 439 Troubleshooting Chapter 10 Search Book TOC Go Back DIAGNOSTICS MENU Jan 20 1993 12:29 Ready Operator ID Sequence # 2716 864.7 756.6 648.5 540.4 432.4 324.3 216.2 108.1 0.5 1.0 1.5 2.0 2.5 3.0 3.5 4.0 4.5 5.0 5.5 6.0 6.5 7.0 7.5 WBC RATE GRAPH PRINT RETURN...
Page 440 Chapter 10 Troubleshooting Search Book TOC Go Back DIAGNOSTICS MENU Jan 28 1993 12:33 Operator ID Ready Sequence # 3143 List Mode WBC: 4350 RBC: 23598 PLT: 2682 2741 Raw Count 31166 4206 Count: 6.23 Avg: 6.22 Count Time Upper: 3.53 Timeout: 6.51 HGB Sample 1: 1218...
Page 441 Troubleshooting Chapter 10 Search Book TOC Go Back When the [MORE] key on the first DIAGNOSTICS MENU Screen pressed, the second DIAGNOSTICS MENU Screen (see Figure 10.9) and the following soft key labels are displayed: MOTOR OPERATION SOLENOID OPERATION PUMP OPERATION INITIALIZATION MORE MAIN...
Page 442 Chapter 10 Troubleshooting Search Book TOC Go Back When the [PUMP OPERATION] key is pressed, the following soft key labels (see Figure 10.10) are displayed: PUMP OPERATION VACUUM ON VACUUM OFF (The key label alternates between these two selections.) PRESSURE ON PRESSURE OFF (The key label alternates between these two selections.)
Page 443 Troubleshooting Chapter 10 Search Book TOC Go Back When the [VACUUM ON] key is pressed, the key label changes to [VACUUM OFF], the vacuum pump is turned ON and the screen VACUUM displays the message VACUUM IS ON. (See Figure 10.11.) Press the [VACUUM OFF] key to turn the pump OFF.
Page 444 Chapter 10 Troubleshooting Search Book TOC Go Back This key is useful for troubleshooting pressure problems. If the pump does not turn ON when the key is pressed, the pump may be the cause of the pressure problem. When the [INHIBIT PUMPS] key is pressed, the key label changes to [ENABLE PUMPS], operation of the pumps is inhibited (no vacuum or INHIBIT pressure is produced) and the screen displays the appropriate message.
Page 445: Figure 10.13: Vacuum Test Screen
Troubleshooting Chapter 10 Search Book TOC Go Back DIAGNOSTICS MENU Jan 20 1993 12:39 Vacuum Recovery Time Test Operator ID Sequence # 2716 Time elapsed : 3.3 Figure 10.13: Vacuum Test Screen When the [PRESSURE TEST] key is pressed, the system releases the pressure to atmosphere and then monitors the amount of time required PRESSURE for it to return to the correct level.
Page 446: Figure 10.14: Third Diagnostics Menu Screen
Chapter 10 Troubleshooting Search Book TOC Go Back When the [MORE] key is pressed, the third DIAGNOSTICS MENU Screen (see Figure 10.14) and the following soft key labels are displayed: MORE DIGITAL READINGS VOLTAGE READINGS MORE PRINT MAIN DIAGNOSTICS MENU Jan 18 1993 10:21 Operator ID...
Page 447 Troubleshooting Chapter 10 Search Book TOC Go Back When the [VOLTAGE READINGS] key is pressed, the voltage and vacuum/pressure values from a test point, measured at the moment when VOLTAGE the key was pressed, is displayed. (See Figure 10.15.) The following READINGS additional soft key labels are displayed: FINISH SELECT...
Page 448 Chapter 10 Troubleshooting Search Book TOC Go Back When the [MORE] key is pressed, the fourth DIAGNOSTICS MENU Screen (see Figure 10.16) and the following soft key labels are displayed: MORE GAIN ADJUSTMNT WBC DATA RBC DATA PLT DATA MORE PRINT MAIN These keys are for service use only.
Page 449 Troubleshooting Chapter 10 Search Book TOC Go Back When the [MORE] key is pressed, the fifth and last DIAGNOSTICS MENU Screen (see Figure 10.17) and the following soft key labels are MORE displayed: AUTO-SAMP VERSION* BAR CODE ALIGNMENT* BAR CODE VERIFY* SERIAL TEST MORE PRINT...
Page 450 Chapter 10 Troubleshooting Search Book TOC Go Back This key is used to display the software version installed in the Sample Loader. The Sample Loader must be ON before the key is pressed. When AUTO-SAMP the [AUTO-SAMP VERSION] key is pressed, the screen displays the VERSION following message (see Figure 10.18): AUTO-SAMPLER SOFTWARE: followed by the version...
Page 451: Figure 10.19: Serial Test Screen
Troubleshooting Chapter 10 Search Book TOC Go Back The [SERIAL TEST] key is used to test the functionality of the external computer port (RS-232 standard), referred to as the “serial interface SERIAL connector” on the Serial Test Screen, at the rear of the Data Station. This TEST test is designed to assist in troubleshooting problems with interfacing to a Laboratory Information System (LIS).
Page 452: Figure 10.20: Serial Test Transmit Message Screen
Chapter 10 Troubleshooting Search Book TOC Go Back The [STOP TRANSMISS] key is used to stop any transmission that is in progress to an LIS. When the key is pressed, any transmission in progress STOP is aborted. TRANSMISS When the [TRANSMIT MESSAGE] key is pressed, the message “CD- 3000 serial interface test”...
Page 453 Troubleshooting Chapter 10 Search Book TOC Go Back The [DIAGNOSTICS] key is used to return to the previous DIAGNOSTICS MENU Screen. DIAGNOSTICS The [MORE] key is used to return to the first DIAGNOSTICS MENU Screen. MORE 10-24 CELL-DYN® 3000 System Operator’s Manual 9140240E —...
Page 454: Troubleshooting Guide
• Measurement — related to sample analysis Typically, hardware and software problems are corrected by an authorized Abbott service representative. Measurement problems are generally operator correctable. This category is further subdivided into problems related to sample handling, maintenance or calibration.
Page 455: Obtaining Technical Assistance
Book TOC Go Back Obtaining Technical Assistance Technical assistance is obtained by calling the Abbott Customer Support Center at 1 (800) CELL DYN. It is important to provide the Customer Support Specialist with a clear and detailed description of the problem.
Page 456: Troubleshooting Procedures
The procedures in this section are for troubleshooting purposes only. A specific procedure should be performed when indicated in this chapter or at the request of an Abbott Customer Support Specialist. WARNING: Potential Biohazard. Follow established biosafety practices when performing maintenance, service or troubleshooting procedures.
Page 457: Power Off Procedure
Troubleshooting Chapter 10 Search Book TOC Go Back Power OFF Procedure It is not necessary to power OFF the system under routine operating conditions. The system should be powered OFF if certain service is performed, if the system is moved or if the system will be inactive for an extended period of time (longer than seven days).
Page 458 Chapter 10 Troubleshooting Search Book TOC Go Back During the initialization process, the Data Station software is accessed and downloaded to the Analyzer. Once this is accomplished, all Analyzer motors and pumps are moved to their “home” positions. (Increased motor noises are normal during this process.) When the initialization has been successfully completed, the message INITIALIZED is displayed in the status box.
Page 459: Unclogging The Open Sample Aspiration Probe
Troubleshooting Chapter 10 Search Book TOC Go Back Unclogging the Open Sample Aspiration Probe The open sample aspiration probe is thoroughly cleaned whenever the Auto-Clean procedure is performed. If a blockage is suspected, it may be cleared as directed in the following procedure. Materials Required 1.
Page 460: Figure 10.21: Open Sample Aspiration Probe
Chapter 10 Troubleshooting Search Book TOC Go Back Silicon Tubing Sleeve Disconnect At This Point Open Sample Aspiration Probe Locking Bracket Wash Block Figure 10.21: Open Sample Aspiration Probe 2. Carefully insert the monofilament line into the probe and push it down through the probe until it extends from the end.
Page 461: Operator-Replaceable Components
Always wear appropriate personal protective equipment when changing any component. Operator-Replaceable Fuse The CELL-DYN 3000 has a fuse located above the power cord connector on the rear panel. It should only be replaced with the following types of fuses: For 220-volt operation, a 4-amp slow-blow fuse For 110-volt operation, an 8-amp slow-blow fuse Replacement fuses are provided in the accessory kit.
Page 462: Sample Loader Aspiration Needle Or Vent Needle
Chapter 10 Troubleshooting Search Book TOC Go Back Sample Loader Aspiration Needle or Vent Needle The Sample Loader aspiration needle or vent needle should be replaced if it is accidentally bent or if it cannot be unplugged. The Sample Loader aspiration needle and vent needle assemblies are depicted in Figure...
Page 463: Needle Assembly
Troubleshooting Chapter 10 Search Book TOC Go Back Aspiration Vent Tubing Tubing Locking Screw Locking Screw Mounting Bracket Mounting Bracket Aspiration Needle Aspiration Needle Wash Block Vent Needle Waste Tubing Vent Port Needle Wash Block Mixing Head Figure 10.22: Sample Loader Vent/Aspiration Needle Assembly Procedure 1.
Page 464 Chapter 10 Troubleshooting Search Book TOC Go Back 5. Remove the four thumbscrews from the sides of the Sample Loader tower and remove the cover. 6. Remove the two thumbscrews from the Sample Loader manual keyboard cover and remove it. (Refer to Figure 12.5, Operation Keyboard.) 7.
Page 465: Aperture
Troubleshooting Chapter 10 Search Book TOC Go Back 18. Run the two diluent tubes and verify proper needle movement. Check to be sure the background count is acceptable on the last cycle. NOTE: If either needle does not move up and down smoothly, carefully check to be sure the locking screw is tight and that the tubing attached to the needle moves freely.
Page 466: Syringes
Chapter 10 Troubleshooting Search Book TOC Go Back Syringes If a syringe is cracked or broken, it should be replaced. It may also be necessary to replace a syringe if no other solution to a problem is found. If this action is indicated by the Customer Support Center, obtain the appropriate replacement syringe.
Page 467: Troubleshooting Tips And Techniques
Troubleshooting Chapter 10 Search Book TOC Go Back Troubleshooting Tips and Techniques Introduction Effective troubleshooting is possible only when the problem is clearly recognized and the probable cause is isolated. This is always facilitated by obtaining sufficient information and data pertaining to the specific problem.
Page 468: Troubleshooting Reagent Problems
Chapter 10 Troubleshooting Search Book TOC Go Back Troubleshooting Reagent Problems If a reagent (or reagents) is suspected as the cause of a particular problem, replace the container. However, the Analyzer has reservoirs which contain a small amount of reagent to maintain the supply within the system.
Page 469: Messages
Troubleshooting Chapter 10 Search Book TOC Go Back Troubleshooting RBC Clog and Flow Error Messages 1. Remove the front covers and observe the metering tube while a cycle is in progress. Approximately 10–15 seconds after the start of the cycle, the metering tube should be flushed of all liquid. Verify that the liquid is completely flushed from the tube.
Page 470: Troubleshooting Imprecise Or Inaccurate Data
Chapter 10 Troubleshooting Search Book TOC Go Back 2. From the first DIAGNOSTICS MENU Screen, press [CNT RATE SUMMARY]. 3. Press [WBC CNT RATE] to display the data for the kinetic rate followed by [PRINT] to obtain a printout. 4. Press [WBC RATE GRAPH] to display the graph of the kinetic data followed by [PRINT] to obtain a printout.
Page 471 Troubleshooting Chapter 10 Search Book TOC Go Back If necessary, refer to the directions given in Chapter 5, Operating Instructions, for customizing the display. • Obtain printouts of the WBC kinetic data for several samples. From the first DIAGNOSTICS MENU Screen, press [CNT RATE SUMMARY].
Page 472: Messages And Fault Conditions
Chapter 10 Troubleshooting Search Book TOC Go Back Messages and Fault Conditions Overview Messages displayed on the RUN Screen in the status box or on the bulletin line are divided into two categories, instrument messages and parameter flagging Messages. Parameter flagging messages are discussed in Chapter 3, Principles of...
Page 473 Troubleshooting Chapter 10 Search Book TOC Go Back NOTES 10-44 CELL-DYN® 3000 System Operator’s Manual 9140240E — May 1995...
Page 474: Summary Of Table
Chapter 10 Troubleshooting Search Book TOC Go Back Summary of Table 10.1, Instrument Status Conditions Condition Page Ready ................10-46 Selecting open/closed mode .
Page 475: Table 10.1: Instrument Status Conditions
Troubleshooting Chapter 10 Search Book TOC Go Back Table 10.1: Instrument Status Conditions The following abbreviations are used in this table: BL — Bulletin Line SB — Status Box __________________________________________________________ Ready/SB – – – – – – – – – – – – – – Explanation/Action– – – – – – – – – – – – – - The Analyzer is ready to process samples.
Page 476: Instrument Status Conditions
Chapter 10 Troubleshooting Search Book TOC Go Back Table 10.1 Instrument Status Conditions (Continued) Initialized/SB – – – – – – – – – – – – – Explanation/Action– – – – – – – – – – – – – – – The Analyzer hardware initialization is complete.
Page 477 Troubleshooting Chapter 10 Search Book TOC Go Back Table 10.1 Instrument Status Conditions (Continued) Clearing fault/SB – – – – – – – – – – – – – Explanation/Action– – – – – – – – – – – – – – – The [CLEAR FAULT] key was pressed after an operator-correctable fault was detected.
Page 478 Chapter 10 Troubleshooting Search Book TOC Go Back Table 10.1 Instrument Status Conditions (Continued) Westgard Warning — See Levey Jennings/BL. The message is displayed on the VIEW QC LOG Screen only. – – – – – – – – – – – – – – Explanation/Action– – – – – – – – – – – – – – The Westgard Rules were selected during set up of the QC file and the data in the file has violated one or more of the selected rules.
Page 479 Troubleshooting Chapter 10 Search Book TOC Go Back Table 10.1 Instrument Status Conditions (Continued) Bar Code flag not allowed to change unless Work List is purged/BL – – – – – – –– – – – – – – Explanation/Action– – – – – – – – – – – – – – – The [BAR CODE ON] or [BAR CODE OFF] key was pressed and there is an existing work list.
Page 480 Chapter 10 Troubleshooting Search Book TOC Go Back Table 10.1 Instrument Status Conditions (Continued) Auto Sampler Busy/BL – – – – – – – – – – – – – Explanation/Action– – – – – – – – – – – – – – – An action was requested during Sample Loader operation and the Sample Loader cannot perform it.
Page 481 Troubleshooting Chapter 10 Search Book TOC Go Back Table 10.1 Instrument Status Conditions (Continued) Auto Sampler cannot be started if the safety cover is off/BL – – – – – – – – – – – – – – Explanation/Action– – – – – – – – – – – – – – The Sample Loader START key was pressed and the safety interlock switch did not sense that the safety cover was in place.
Page 482 Chapter 10 Troubleshooting Search Book TOC Go Back Summary of Table 10.2, General Fault Conditions Condition Page Not Ready: See DIAG or Not Ready: See Special ......... . 10-54 Unitialized.
Page 483: Table 10.2: General Fault Conditions
Troubleshooting Chapter 10 Search Book TOC Go Back Table 10.2: General Fault Conditions The following abbreviations are used in this table: BL — Bulletin Line SB — Status Box Information for each message is listed in order from the most likely cause of the message to the least likely cause of the message.
Page 484 Chapter 10 Troubleshooting Search Book TOC Go Back Table 10.2 General Fault Conditions (Continued) Uninitialized/SB – – – – Probable Cause – – – – – – – – Corrective Action – – – – Data Station has power 1. Ensure that the Analyzer but the Analyzer is not power cord is connected to responding.
Page 485 Troubleshooting Chapter 10 Search Book TOC Go Back Table 10.2 General Fault Conditions (Continued) Printer (Graphics or Ticket) Unavailable/SB – – – - Probable Cause – – – – – – – - Corrective Action – – – – The print buffer (the 1.
Page 486 Chapter 10 Troubleshooting Search Book TOC Go Back Table 10.2 General Fault Conditions (Continued) Diluent, Lyse, or Sheath empty/SB and BL – – – – – Probable Cause – – – – – – – – Corrective Action – – – – Container is empty.
Page 487 Troubleshooting Chapter 10 Search Book TOC Go Back Table 10.2 General Fault Conditions (Continued) External waste full/SB WARNING: Potential Biohazard. Follow established biosafety practices when performing maintenance, service or troubleshooting procedures. Wear gloves, lab coat, and suitable eye protection. Refer to Chapter 8, Precautions, Limitations and Hazards, for additional information.
Page 488 Chapter 10 Troubleshooting Search Book TOC Go Back Table 10.2 General Fault Conditions (Continued) Shear Valve position fault/BL – – – – Probable Cause – – – – – – – – Corrective Action – – – – The shear valve did not 1.
Page 489 Troubleshooting Chapter 10 Search Book TOC Go Back Table 10.2 General Fault Conditions (Continued) Flow sequence time out <x,x>/BL NOTE: Characters in the brackets identify the problem flow sequence number and flow sequence name. – – – – – Probable Cause – – – – –...
Page 490 Chapter 10 Troubleshooting Search Book TOC Go Back Table 10.2 General Fault Conditions (Continued) Data acquisition overlap/BL – – – – – Probable Cause – – – – – – – – Corrective Action – – – – The timing of commun- 1.
Page 491: General Fault Conditions
Troubleshooting Chapter 10 Search Book TOC Go Back Table 10.2 General Fault Conditions (Continued) Message acknowledgment time out/BL – – – – – Probable Cause – – – – – – – – – Corrective Action – – – – Communication between 1.
Page 492 Chapter 10 Troubleshooting Search Book TOC Go Back Table 10.2 General Fault Conditions (Continued) Bad checksum in non-volatile RAM/BL – – – – – Probable Cause – – – – – – – – Corrective Action – – – – When the system was 1.
Page 493 Troubleshooting Chapter 10 Search Book TOC Go Back Table 10.2 General Fault Conditions (Continued) Auto-Sampler alarm condition <u>; see DIAG/BL – – – – – Probable Cause – – – – – – – Corrective Action – – – – – Sample Loader rack 1.
Page 494 Chapter 10 Troubleshooting Search Book TOC Go Back Table 10.2 General Fault Conditions (Continued) Auto-Sampler alarm condition <x,x> see DIAG/BL NOTE: The characters in the brackets identify the condition. – – – – – Probable Cause – – – – –...
Page 495 Troubleshooting Chapter 10 Search Book TOC Go Back NOTES 10-66 CELL-DYN® 3000 System Operator’s Manual 9140240E — May 1995...
Page 496 Chapter 10 Troubleshooting Search Book TOC Go Back Summary of Table 10.3, Sample-Related Fault Conditions Condition Page Sampling Error — Incomplete Aspiration ..........10-68 Mixing Error .
Page 497: Sample-Related Fault Conditions
Troubleshooting Chapter 10 Search Book TOC Go Back Table 10.3: Sample-Related Fault Conditions The following abbreviations are used in this table: BL — Bulletin Line SB — Status Box Information for each message is listed in order from the most likely cause of the message to the least likely cause of the message.
Page 498: Table 10.3: Sample-Related Fault Conditions
Chapter 10 Troubleshooting Search Book TOC Go Back Table 10.3 Sample-Related Fault Conditions (Continued) Mixing Error/BL MIXING ERR is displayed on the RUN Screen to the right of the MCH result. SAMPLING ERR is displayed to the right of the MCHC result. MIXING ERR is printed on the graphics report.
Page 499 Troubleshooting Chapter 10 Search Book TOC Go Back Table 10.3 Sample-Related Fault Conditions (Continued) Auto-Sampler consecutive data faults/BL – – – – – Probable Cause – – – – – – – – Corrective Action – – – – During sample processing, 1.
Page 500 Chapter 10 Troubleshooting Search Book TOC Go Back Table 10.3 Sample-Related Fault Conditions (Continued) WBC Metering Fault — Flow Error/BL WBC FLOW ERROR is displayed on the RUN Screen to the right of the NEU results. WBC FLOW is printed on the graphics report. Results for WBC and Differential are suppressed.
Page 501 Troubleshooting Chapter 10 Search Book TOC Go Back Table 10.3 Sample-Related Fault Conditions (Continued) RBC Metering Fault — Clog or Flow Error/BL CLOG or FLOW ERROR is displayed on the RUN Screen to the right of the RDW result. RBC CLOG or RBC FLOW is printed on the graphics report. Results for RBC, PLT and related parameters are suppressed.
Page 502 Chapter 10 Troubleshooting Search Book TOC Go Back Summary of Table 10.4, Non-Functional Fault Conditions Condition Page Analyzer or Data Station will not power ON..........10-74 No screen display..
Page 503: Table 10.4: Non-Functional Fault Conditions
Troubleshooting Chapter 10 Search Book TOC Go Back Table 10.4: Non-Functional Fault Conditions Analyzer or Data Station will not power ON – – – – – Probable Cause – – – – – – – – Corrective Action – – – – Power source is defective.
Page 504 Chapter 10 Troubleshooting Search Book TOC Go Back Table 10.4 Non-Functional Fault Conditions (Continued) MAIN MENU Screen is not displayed after initialization – – – – – Probable Cause – – – – – – – – Corrective Action – – – – There is a floppy disk in 1.
Page 505: Non-Functional Fault Conditions
Troubleshooting Chapter 10 Search Book TOC Go Back Table 10.4 Non-Functional Fault Conditions (Continued) The word FAULT on the Analyzer status indicator panel is illuminated in red NOTE: This type of fault is usually accompanied by a message in the status box and/or on the bulletin line.
Page 506 Chapter 10 Troubleshooting Search Book TOC Go Back Table 10.4 Non-Functional Fault Conditions (Continued) Background count is outside acceptable limits – – – – – Probable Cause – – – - – – – – Corrective Action – – – – The Analyzer front covers 1.
Page 507 Troubleshooting Chapter 10 Search Book TOC Go Back Table 10.4 Non-Functional Fault Conditions (Continued) The Data Station keyboards are not operational – – – – – Probable Cause – – – – – – – Corrective Action – – – – – The computer is perfor- 1.
Page 508 Chapter 10 Troubleshooting Search Book TOC Go Back Table 10.4 Non-Functional Fault Conditions (Continued) The Sample Loader does not power ON – – – – – Probable Cause – – – – – – – – Corrective Action – – – – The power cord is loose 1.
Page 509 Troubleshooting Chapter 10 Search Book TOC Go Back NOTES 10-80 CELL-DYN® 3000 System Operator’s Manual 9140240E — May 1995...
Page 510 Chapter 11 Search Book TOC Go Back Printer Chapter Table of Contents Introduction ..........11-1 Printing Graphics Reports .
Page 511 Chapter 11 Table of Contents Search Book TOC Go Back NOTES Table of Contents-2 CELL-DYN® 3000 System Operator’s Manual 9140240E — May 1995...
Page 512: Introduction
Chapter 11 Search Book TOC Go Back Printer Introduction The CELL-DYN® 3000 has the capability of printing graphics reports and ticket printouts. The printer can be configured as either a graphics printer for graphics reports or a ticket printer for blank or preprinted tickets.
Page 513: Loading Individual Tickets
Printer Chapter 11 Search Book TOC Go Back To print tickets, the printer cable must be connected to the ticket printer port on the back of the Data Station. (See Figure 2.1 for the location of this port.) Refer to the Customize Printout section in the Set Up...
Page 514 Chapter 11 Printer Search Book TOC Go Back Paper Selection Printhead Paper Lever Lever in (Detail View) Headgap Lever (Detail View) Single-Sheet Position Paper Guide Paper Selection Lever in Tractor-Feed (Lower) Red Line Position on Paper Shield Paper Separator Bail Lever Printer Power On/Off Switch Access Cover...
Page 515 Printer Chapter 11 Search Book TOC Go Back 7. Pull the bail lever forward. The ticket will automatically feed into place. Release the paper bail lever. 8. Be sure the printer is deselected (SEL indicator is not illuminated) and set the top of form by pressing and holding the TOF/QUIET key and pressing the FORM FEED key to move the ticket up or pressing the LINE FEED key to move the ticket down.
Page 516: Maintenance
Chapter 11 Printer Search Book TOC Go Back Maintenance Every six months (or after 300 hours of operation), use a clean, dry cloth to dust the area around the carriage shaft and platen. Be sure to remove any loose particles of paper. Do not use solvents or strong detergents on the cabinet.
Page 517: Troubleshooting
OFF, wait about five seconds, turn the power ON again and press the [PRINT] key on the Data Station screen. If the message is still displayed, there may be an internal printer error. Contact the Abbott Customer Support Center for assistance at 1 (800) CELL DYN. 11-6 CELL-DYN®...
Page 518 Chapter 12 Search Book TOC Go Back Sample Loader Chapter Table of Contents Overview ..........12-1 Labels .
Page 519 Chapter 12 Table of Contents Search Book TOC Go Back NOTES Table of Contents-2 CELL-DYN® 3000 System Operator’s Manual 9140240E — May 1995...
Page 520: Chapter 12. Sample Loader
Chapter 12 Search Book TOC Go Back Sample Loader Overview The Sample Loader for the CELL-DYN® 3000SL is an automated microprocessor-based sample-handling system designed to fit directly in front of the Analyzer. (See Figure 12.1.) The Analyzer communicates electronically with the Sample Loader and vice versa. The Sample Loader delivers blood samples (and their identification information) to the CELL-DYN 3000SL for analysis.
Page 521: Labels
Sample Loader Chapter 12 Search Book TOC Go Back Station 2 Tower Station 1 Mixing Station 3 Venting Aspirating Figure 12.2: Rack Movement The tube racks move from the right side of the tray, through the three tower stations, to the left side of the tray. (See Figure 12.2.) The rack on the right side at the back of the tray is the first to be processed.
Page 522: Bar Code Label Placement
Chapter 12 Sample Loader Search Book TOC Go Back Bar Code Label Placement All labels should be placed on the tubes securely and without flaps or edges sticking out. Labels should not cover the cap (high collar) or the bottom (tail) of the tube. (See Figure 12.3.) Excessive numbers of labels may prevent tubes from mixing properly.
Page 523: Sample Loader Components
Sample Loader Chapter 12 Search Book TOC Go Back Sample Loader Components The Sample Loader consists of a main module and a tower unit as depicted in Figure 12.4. The functions of the keys on the Sample Loader are discussed briefly in this section. The Sample Loader operation keyboard is shown in...
Page 524: Sample Loader Operation Keyboard Keys
Chapter 12 Sample Loader Search Book TOC Go Back Manual Thumbscrews Operation Keys Primary Keys Figure 12.5: Operation Keyboard Sample Loader Operation Keyboard Keys The operator controls the Sample Loader using the operation keyboard. See Figure 12.5. Primary Keys The primary Sample Loader keys are: INIT—Initiates the initialization cycle.
Page 525 These keys are used to check specific Sample Loader functions during troubleshooting or service. These keys should only be used at the direction of the Customer Support Center an authorized Abbott representative. 12-6 CELL-DYN® 3000 System Operator’s Manual 9140240E — May 1995...
Page 526: Operating Principles
Chapter 12 Sample Loader Search Book TOC Go Back Operating Principles Functional Description The Sample Loader is designed to fit directly in front of the Analyzer. A metal platform attached to the front of the Analyzer pedestal provides an extension to support the Sample Loader.
Page 527: Figure 12.6: Tower Stations
Sample Loader Chapter 12 Search Book TOC Go Back Station 3 Aspirating Station 1 Venting Station 2 Mixing Figure 12.6: Tower Stations When the tube is at Station 1 or Station 3, a plunger (vial positioning mechanism) positions the tube vertically in the rack and holds it while the tube is vented or the sample is aspirated.
Page 528 Chapter 12 Sample Loader Search Book TOC Go Back A clear plexiglass safety cover fits on top of the main Sample Loader module. This covers the tray and the processing stations to prevent aerosol contamination, exposure to the bar code reader laser and the needles while the Sample Loader is processing specimens.
Page 529: Figure 12.7: Tube Racks
Sample Loader Chapter 12 Search Book TOC Go Back Black End Rack Visual Indicator Label Bar Coded (END RACK ONLY) Position Rack ID ID Label Number Label Tube Rack Bar Coded Rack ID Label Black End Rack Sensor Label Orient Numbered End (END RACK ONLY) DOWNWARD Figure 12.7:...
Page 530 Chapter 12 Sample Loader Search Book TOC Go Back The Sample Loader bar coded rack ID label serves as the identification of tube position number 1. Bar coded position ID labels, numbers 2 through 10, used for identification of the remaining tube positions, are encoded as letters of the alphabet.
Page 531: Function Sequence
Sample Loader Chapter 12 Search Book TOC Go Back CAUTION: If a fault occurs which requires or causes the Sample Loader to be reinitialized, the operator must remove the samples that have been processed to avoid accidentally repeating a sample. Whenever the Sample Loader reinitializes, the tube rack which was under the tower when the Sample Loader stopped moves back to the starting position.
Page 532 Chapter 12 Sample Loader Search Book TOC Go Back 5. The first sample is then mixed by counter-rotation. NOTE: Tubes must be able to spin freely while in the tube racks. Tubes with excessive numbers of labels or with label flaps sticking out (Figure 12.3) will not spin properly and will trigger...
Page 533 Sample Loader Chapter 12 Search Book TOC Go Back 10. These sequences are repeated until the end rack sensor detects the end rack. When all tubes in this rack are processed, the Sample Loader automatically stops and audible beeps alert the operator that processing is completed.
Page 534: Routine Operating Procedures
Chapter 12 Sample Loader Search Book TOC Go Back Routine Operating Procedures Directions for Routine Operating Procedures with the Sample Loader given in Chapter 5, Operating Instructions. Maintenance Maintenance procedures on the Sample Loader should be performed as directed in Chapter 9, Maintenance.
Page 535 Sample Loader Chapter 12 Search Book TOC Go Back NOTES 12-16 CELL-DYN® 3000 System Operator’s Manual 9140240E — May 1995...
Page 536: Appendix A. Bar Codes
The major elements in a bar coding system are: • The computer and its software, which interpret and store bar code data (for the CELL-DYN 3000, this is accomplished by the Data Station and its software) • The scanning device which “decodes” the information can be an...
Page 537: Understanding The Label "Code
Bar Codes Appendix A Search Book TOC Book TOC Go Back Understanding the Label “Code” In all bar code symbologies, the code consists of elements (single bars or white spaces) and characters (groups of elements which stand for numbers or letters). For example, in Code 39, a widely used symbology, each code character contains nine elements, at least three of which must be wide.
Page 538: Cell-Dyn 3000 Bar Code Specifications
CELL-DYN 3000 Bar Code Specifications The CELL-DYN 3000 Sample Loader Bar Code Reader can read Code 39, Interleaved 2 of 5 and Codabar formats. The Sample Loader can read these formats interchangeably if the check digit is disabled by using the...
Page 539: Cell-Dyn Bar Code Labels
Bar Codes Appendix A Search Book TOC Book TOC Go Back Maximum Label Width 1.25 inches Minimum Quiet Zone Maximum 0.25 inches Label Length 2.0 inches Minimum Bar Length 0.5 inches Figure A.1: Bar Code Label Specifications CELL-DYN Bar Code Labels CELL-DYN 4-digit bar code labels (Code 39 Format) are available for the Sample Loader (L/N 99650-01 for one roll, or L/N 99651-01 for a box of ten).
Page 540: Bar Code Label Placement
Appendix A Bar Codes Search Book TOC Book TOC Go Back Bar Code Label Placement • All labels should be placed on the tubes securely and without flaps sticking out. (See Figure A.2.) Excessive numbers of labels may prevent tubes from mixing properly. •...
Page 541: Acknowledgment
Bar Codes Appendix A Search Book TOC Book TOC Go Back Acknowledgment The authors wish to acknowledge Computype, Inc. of St. Paul, MN for providing their booklet "Bar Coding and Productivity" to assist in the writing of this appendix. CELL-DYN® 3000 System Operator’s Manual 9140240E —...

Abbott CELL-DYN 3000 Operator's Manual

Introduction

Chapter 1. System Description

Chapter 2. Installation

Chapter 3. Principles of Operation

Chapter 4. System Specifications

Chapter 5. Operating Instructions

Chapter 6. Calibration

Quick Links

Troubleshooting

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Summary of Contents for Abbott CELL-DYN 3000