Page 1 ADVIA 70 Hematology System Operator's Guide Part No. 083D0001-01...
Page 2 Bayer Corporation. WARNING If the ADVIA 70 Hematology System is used in a manner not specified by Bayer Corporation, the protection provided by the equipment may be impaired. See Appendix B for warning and hazard statements.
Page 3: Table Of Contents
This Manual and Training ..................1-6 SECTION 2 — SETTING UP THE SYSTEM ............2-1 Unpacking the System....................2-2 Setting up the Autosampler (optional)..............2-3 Placement of the ADVIA 70 Hematology System .............2-5 General Environment..................2-5 Power Requirements ..................2-5 Space Requirements ..................2-6 Setting up the ADVIA 70 Hematology System ............2-6 ADVIA 70 Reagents...................2-6...
Page 4 ADVIA 70 Lyse....................2-8 Waste ........................2-8 Computer......................2-8 Computer Monitor....................2-9 Printer (optional)....................2-9 Keyboard ......................2-9 Pointing Device....................2-9 Starting the System ....................2-10 Software Configuration ...................2-10 Auxiliary Menu ......................2-11 Patient Ranges and Action Limits ..............2-13 Autorecount Feature..................2-15 Printer (optional)....................2-16 Transfer Settings .....................2-17 Date/Time and Regional Settings ..............2-18 Customize Report....................2-20...
Page 5 Hematocrit Determination (Hct) ................3-18 Mean Cell Hemoglobin Determination (MCH)............3-18 Mean Cell Hemoglobin Concentration Determination (MCHC).......3-18 Red Cell Distribution Width (RDW).................3-19 Mean Platelet Volume Determination (MPV) ............3-19 Plateletcrit Determination (Pct) ................3-19 Platelet Distribution Width (PDW)................3-19 Clog Detection ......................3-20 Patient Action Limits and Normal Ranges...............3-20 SECTION 4 —...
Page 6 SECTION 5 — DATA ARCHIVE ................5-1 File System Description....................5-1 Data Archive ......................5-1 Maintenance Log....................5-2 System Log......................5-2 SECTION 6 — DATALOG ...................6-1 General........................6-2 Opening the Datalog....................6-2 Searching the Datalog ....................6-3 Searching by Sequence Number...............6-4 Searching by Patient ID Number ...............6-5 Searching by Patient Name................6-6 Displaying Results ....................6-7 Changing the Patient ID....................6-8 Transferring Data......................6-9...
Page 7 Quality Control Results..................8-10 Submitting Control Data by Disk..............8-12  X Analysis ......................8-12 Establishing  X Target Values................8-14 Activating  X Analysis..................8-14  X Alert ......................8-14 Viewing or Printing  X Graphics ..............8-15 Reviewing Sample Results................8-15 Reviewing Batches ..................8-15 SECTION 9 — MAINTENANCE ................9-1 General........................9-2 Maintenance Log ......................9-3 Adding an Event to the Maintenance Log............9-3...
Page 8 Hematology Flags....................10-7 APPENDIX A — SYSTEM SPECIFICATIONS ........... A-1 Operating Characteristics ..................A-2 Parameters Reported ..................A-2 Scientific Principles....................A-3 Sampling Features....................A-3 Volume Required for Each Analysis..............A-3 Dilution Ratios ....................A-3 Cell Counting Aperture Size ................A-3 Cycle Time......................A-3 Waste Analysis ....................A-3 Performance Specifications ..................A-4 Computer Hardware ....................A-5 Processor and Memory ..................A-5 Display.......................A-5...
Page 9: Figures
APPENDIX B — OPERATIONAL HAZARDS, PRECAUTIONS, AND LIMITATIONS...................... B-1 General........................B-2 Documentation ......................B-3 Electrical Hazards.....................B-3 Instrument Precautions.....................B-3 Reagent Precautions ....................B-3 Maintenance Precautions ..................B-4 Calibration Precautions.....................B-4 Procedural Precautions and Limitations ..............B-5 Results Limitations....................B-5 Limitations of the Hct Determination..............B-6 Limitations of the Platelet Count................B-7 Interpretation of Results....................B-7 APPENDIX C —...
Page 10 Figure 2-11 Printers Window..................2-16 Figure 2-12 Transfer Settings Box .................2-17 Figure 2-13 Date and Time Properties..............2-18 Figure 2-14 Regional Settings ................2-19 Figure 2-15 Laboratory Information Window............2-20 Figure 2-16 Misc Information Window ..............2-21 Figure 2-17 Customer Report Setup Dialog Box ...........2-22 Figure 2-18 Wake Up / Shutdown Dialog Box............2-23 SECTION 3 —...
Page 11 Figure 6-3 Search by Sequence Number ..............6-4 Figure 6-4 Search by Patient ID ................6-5 Figure 6-5 Search by Patient Name .................6-6 Figure 6-6 Results window ..................6-7 Figure 6-7 Changing Patient ID ................6-8 Figure 6-8 Datalog Print Window................6-9 SECTION 7 — CALIBRATION PROCEDURES Figure 7-1 Calibration Menu ..................7-2 Figure 7-2 Calibration Run..................7-3 Figure 7-3 Calibration Summary Window ..............7-4...
Page 12 Figure 9-5 Prime Reagents Window................9-6 Figure 9-6 Preventive Maintenance.................9-8 Figure 9-7 Cleaning the Apertures.................9-10 SECTION 10 — TROUBLESHOOTING Figure 10-1 Normal FS-WA ...................10-8 Figure 10-2 Normal EX-SWA.................10-8 Figure 10-3 N Flag Scattergram ................10-8 Figure 10-4 B Flag Scattergram ................10-9 Figure 10-5 B Flag Scattergram ................10-9 Figure 10-6 L Flag Scattergram................10-10 Figure 10-7 L Flag Scattergram................10-10 FIGURES...
Page 13 Damaged Containers....................4 ADVIA 70 Diluent......................4 ADVIA 70 Lyse......................4 ADVIA 70 KLEEN ......................4 ADVIA 70 Sheath......................4 ADVIA 70 TESTpoint Controls and SETpoint Calibrators ..........5 Laboratory Precautions....................5 Supplementary Data .....................5 Service Assistance ....................6 This Manual and Training..................6...
Page 14: Section 1 - Introduction
Intended Use ® The ADVIA 70 Hematology System is intended for the in vitro quantitative determination of the following parameters: • white blood cell count (WBC) with a 5-part differential grouped as: neutrophils (Neut) lymphocytes (Lymp) monocytes (Mono) eosinophils (Eos) basophils (Bas) •...
Page 15: Reagents, Calibrators, And Controls
In the (optional) Autosampler Mode, the system sequences the operation of the thirty tube ADVIA 70 autosampler, mixes the blood samples, pierces the tube cap (septum), aspirates the needed amount of whole blood, automatically dilutes the sample, and performs the analysis.
Page 16: Damaged Containers
ADVIA 70 Lyse must be used with ADVIA 70 Diluent. This reagent is stable for 30 days after opening. ADVIA 70 KLEEN ADVIA 70 KLEEN is an enzyme-based, azide-free, isotonic, cleaning solution and wetting agent.
Page 17: Advia 70 Testpoint Controls And Setpoint Calibrators
Whole-blood calibrators and controls are used to calibrate and verify accurate operation of the ADVIA 70 Hematology System. ADVIA 70 SETpoint Calibrator is a commercially prepared whole-blood product with assigned values traceable to reference methods. Once they are opened, calibrators are stable for 5 days.
Page 18: Service Assistance
Service Assistance If the ADVIA 70 Hematology System does not operate properly, follow the directions in Section 10 - Troubleshooting. If the problem cannot be corrected with the information and procedures presented, contact your distributor or Bayer technical service for assistance.
Page 19: Section 2 - Setting Up The System
SECTION 2 — SETTING UP THE SYSTEM Unpacking the System ..................2 Setting up the Autosampler (optional)................3 Placement of the ADVIA 70 Hematology System ..........5 General Environment....................5 Power Requirements ....................5 Space Requirements ....................6 Setting up the ADVIA 70 Hematology System ............6 ADVIA 70 Reagents.....................
Page 20: Unpacking The System
Figure 2-1 Rear Panel View Unpacking the System 1. Unpack the equipment carefully and examine all items for damage. File a claim with the shipping carrier immediately if physical damage is discovered. 2. Check the equipment received against the packing list to ensure that the shipment is complete.
Page 21: Setting Up The Autosampler (Optional)
7. Manually remove the front part of the slide valve and the red and white label. Spread one drop of slide valve lubricant on the surface of the front part. Replace the front part of the slide valve and ensure the part is correctly placed by matching the pin on the slide valve part to the groove in the mounting shaft.
Page 22: Figure 2-3 Left Side Of The Autosampler
4. Connect the red, waste-line tubing to the waste-line port at the back of the autosampler. Allow it to drain into the waste container or sink. 5. Remove the front cover of the autosampler, being careful not to disconnect the 24-pin cable connecting the front cover to the body of the autosampler. 6.
Page 23: Placement Of The Advia 70 Hematology System
Placement of the ADVIA 70 Hematology System You must place the ADVIA 70 Hematology System in a location that meets the following installation requirements: General Environment The environment must be as free as possible from dust, mechanical vibrations, loud noises, and electrical interference. Avoid proximity to brush-type motors, flickering fluorescent lights, and electrical contacts that regularly open and close.
Page 24: Space Requirements
70 reagents only. ADVIA 70 Reagents The ADVIA 70 reagent system consists of either a 10-L or 20-L container of ADVIA 70 Diluent, a 5-L container of ADVIA 70 KLEEN, a 10-L container of ADVIA 70 Sheath reagent, and a 500-mL container of ADVIA 70 Lyse. This quantity of reagent is enough for about 500 tests, although the actual number will depend on the daily workload.
Page 25: Supply Tubing Assemblies
Remove the cap and seal from the ADVIA 70 Diluent container and replace it with the cap and supply tube. Slide the tube down through the cap until it touches the bottom of the container.
Page 26: Advia 70 Sheath
Remove the cap and seal from the ADVIA 70 Sheath reagent container and replace it with the cap and supply tube. Slide the tube down through the cap until it touches the bottom of the container.
Page 27: Computer Monitor
Computer Monitor The system is equipped with a color monitor connected to the computer unit. The Windows 2000 settings for the monitor are 256 colors with 800 x 600 pixel screen resolution. The monitor screen provides .28 mm dot pitch or better. Connect the monitor power cable and the video cable to the receptacles on the rear of the computer.
Page 28: Starting The System
Figure 2-6 Main Menu Software Configuration The ADVIA 70 Hematology System is a flexible laboratory instrument that can be tailored to your work environment. You can set options for each of the following features that are specifically addressed by the system software: •...
Page 29: Auxiliary Menu
• patient normal ranges • action limits Participating physicians, pathologists and laboratory staff should discuss these topics and then set the necessary options. Auxiliary Menu From the Main Menu (Figure 2-6), press F8 to open the Auxiliary Menu (Figure 2-7). Figure 2-7 Auxiliary menu Subsequent lower-level menus and options configure the system for site-specific preferences.
Page 30 F3 - Transfer Settings Choose this option to configure the data output stream for the laboratory information system. F4 - Date / Time Choose this option to set the analyzer clock and calendar. The date and time screen and printout formats are selected here. F5 - Customize Report Choose this option to select the format of the printed reports and the site-specific data for the report heading.
Page 31: Patient Ranges And Action Limits
Patient Ranges and Action Limits The normal range and action limit data are intended to assist the user by calling attention to unexpected results that need immediate attention. This is subjective in nature and varies with the patient and practice. The default values supplied are useful as a guide when working with a normal patient population.
Page 32: Figure 2-9 Set/Review Patient Range
of a range should be one month greater than the From Age To Age the previous range. There are provisions for eight ranges. For the last range, leave the blank to indicate that there is no maximum for the range. To Age 4.
Page 33: Autorecount Feature
Autorecount Feature The ADVIA 70 Autosampler is equipped with a feature called Autorecount. This feature automatically reruns a processed sample that displays values outside the action limits set in the system for RBC, WBC, Hgb, MCV/Hct, Plt, or MCHC. To select this feature: 1.
Page 34: Printer (Optional)
Printer (optional) To choose a printer With this option, any printer that is accessible to Windows 2000 may be chosen as the default printer for reports. 1. From the Auxiliary Menu, press to open the Windows 2000 printer selection window (Figure 2-11). 2.
Page 35: Transfer Settings
Transfer Settings To select the data transfer specifications 1. From the Auxiliary Menu, press to open the data Transfer Settings (Figure 2-12) box. 2. Set the characteristics of the serial data transfer baud rate, data bits, parity, and stop bit to match the settings of the serial port on the Laboratory Information System (LIS).
Page 36: Date/Time And Regional Settings
host, select automatic transfer and the analyzer will send the data to the workstation at the completion of each measurement cycle. If this option is not selected, data is released from the system one sample at a time. 6. Click to save the settings.
Page 37: Figure 2-14 Regional Settings
To change the Regional Settings 1. From the Auxiliary Menu, press to open the Date and Time window. 2. From the Date Time window, press to open the Regional Settings Properties box (Figure 2-14). This box offers choices for the character set, the currency format, number field formats, date and time formats.
Page 38: Customize Report
Customize Report This Customize Report window offers options for entering laboratory information, miscellaneous information, and printing criteria for reports. To customize laboratory information 1. From the Auxiliary Menu, press to open the Customize Report window. 2. From the Customize Report window, press to open the Laboratory Information Menu (Figure 2-15).
Page 39: Figure 2-16 Misc Information Window
To customize miscellaneous information Because this information is optional, you do not need to perform this NOTE: procedure unless it is necessary for your laboratory. 1. From the Auxiliary Menu, press to open the Customize Report window. 2. From the Customize Report window, press to open the Misc Information window (Figure 2-16).
Page 40: Figure 2-17 Customer Report Setup Dialog Box
To chose report printing criteria 1. From the Auxiliary Menu, press to open the Customize Report window. 2. From the Customize Report window, press to open the Customer Report Setup dialog box (Figure 2-17), which allows you to choose when the system will print reports.
Page 41: Wake Up And Shutdown
Wake Up and Shutdown The ADVIA 70 Hematology System can perform the daily cleaning function without operator intervention. Placing the analyzer in shutdown status fills the counting chambers with ADVIA 70 KLEEN to prevent protein buildup. The analyzer may always be shutdown or started manually.
Page 42: Advanced Setup
Advanced Setup The Advanced Setup Menu is a protected function that is used at installation and not altered by the operator. This menu provides for selection of Language, Unit of Measurement, Calibration scheme, and the System Log. If you want to change the setup, contact your distributor or Bayer Technical Service.
Page 43: Section 3 - System Principles
SECTION 3 — SYSTEM PRINCIPLES General System Design..................2 Sequence of Operation..................2 Dilution Phase ......................2 Counting Phase ......................3 Rinse Phase ........................ 4 Elements of Impedance Cell Counting..............5 Cell Counting and Sizing (RBC, Plt) ..............7 Cell Counting (WBC)...................13 White Cell Differential..................13 Hemoglobin Determination (Hgb)..............17 Mean Cell Volume Determination (MCV) ............18 Hematocrit Determination (Hct) .................18...
Page 44: General System Design
This portion of the cycle covers the aspiration of sample and the dilution of the sample into three components. At the beginning of the cycle, the cuvettes are filled with ADVIA 70 Diluent that was used by the last cycle to rinse the previous sample residue. The Hgb measurement is made from the contents of the WBC cuvette by measurement of optical absorbency at 540 nm of the lysed WBC dilution.
Page 45: Counting Phase
delivered to the WBC counting bath or cuvette where the lysing reagent is added and mixed with the diluted sample. The second dilution then is a compound dilution of the first dilution (taken from the first dilution before the lysing reagent is added).
Page 46: Rinse Phase
WBC and RBC apertures. At the conclusion of rinsing, the WBC and RBC cuvettes are filled with ADVIA 70 Diluent and the WOC cuvette is filled with ADVIA 70 Sheath to prevent collection of dried salt in the apertures.
Page 47: Elements Of Impedance Cell Counting
Elements of Impedance Cell Counting The ADVIA 70 Hematology System determines values for white blood cells, red blood cells, and platelets through refinements of the well-established impedance method of counting and sizing cells. An electric field is created across an aperture through which blood cells suspended in isotonic diluent pass.
Page 48: Figure 3-2 Impedance Counting System Rbc/Plt
Rinse Drain Stop Valve Valve Sensor ADVIA 70 KLEEN Vacuum Reservoir To Waste Check Valve Figure 3-2 Impedance Counting System RBC/Plt Diluent can have a significant effect on cell size determination. It is important, therefore, to ensure the integrity of diluent by controlling osmolality and protecting it from contamination by bacteria, mold, and debris.
Page 49: Cell Counting And Sizing (Rbc, Plt)
The following sequence of events describes the ADVIA 70 RBC Plt method using the patented von Behrens silencer. The von Behrens silencer provides positive volume measurement and isolates cell-bearing fluid to prevent recirculation.
Page 50: Figure 3-3 Rbc/Plt Counting System - Counting In Process
Cuvette Cells Sensor Dilution Venturi Metering Tube Expansion Chamber Aperture Cuvette Rinse Drain Stop Valve Valve Sensor ADVIA 70 KLEEN Vacuum Reservoir To Waste Check Valve Figure 3-3 RBC/Plt Counting System – Counting in Process SECTION 3 — SYSTEM PRINCIPLES...
Page 51: Figure 3-4 Rbc/Plt Counting System - Counting Complete
As this occurs, the cuvette is drained of cell dilution and rinsed. In Figure 3-6, after adequate rinsing, the count valve is closed and the pressurized ADVIA 70 KLEEN backwashes the aperture to remove any protein buildup from the aperture. SECTION 3 — SYSTEM PRINCIPLES...
Page 52: Figure 3-5 Rbc/Plt Counting System - Rinsing Silencer
Cuvette Cells Sensor Dilution Metering Tube Expansion Chamber Aperture Cuvette Rinse Drain Stop Valve Valve Sensor Pressurized Vacuum Reservoir ADVIA 70 KLEEN To Waste Check Valve Figure 3-5 RBC/PLT Counting System – Rinsing Silencer 3-10 SECTION 3 — SYSTEM PRINCIPLES...
Page 53: Figure 3-6 Rbc/Plt Counting System - Backflush Aperture
Start Sensor Dilution Venturi Metering Tube Expansion Chamber Aperture Cuvette Rinse Drain Stop Valve Valve Sensor Pressurized Vacuum Reservoir ADVIA 70 KLEEN To Waste Check Valve Figure 3-6 RBC/Plt Counting System – Backflush Aperture SECTION 3 — SYSTEM PRINCIPLES 3-11...
Page 54: Figure 3-7 Rbc/Plt Counting System - Cycle Complete
Cuvette Rinse Drain Stop Valve Valve Sensor ADVIA 70 Vacuum Reservoir KLEEN To Waste Check Valve Figure 3-7 RBC/Plt Counting System – Cycle Complete An important feature of these electrical pulses is the relationship of the pulse height to the size of the cell passing through the aperture. Larger particles or cells generate higher pulse amplitudes.
Page 55: Cell Counting (Wbc)
While the size ranges for Plts and RBCs seem to be well separated, in reality each type of cell varies widely in size. RBCs form nearly a bell shaped curve (when plotted by number of cells per size vs. size); Plts form a lognormal distribution.
Page 56: Figure 3-8 Wbc Differential - Flow Cytometer Scheme
Hydrodynamic focusing, shown in Figure 3-9, creates a monofile of cells surrounded by ADVIA 70 Sheath flowing in the center of the channel of the flowcell. As the cells pass through the laser beam, they scatter light in unique patterns dependent on the size and structure of the cell.
Page 57: Figure 3-9 Flow Cytometer - Hydrodynamic Focused Cell Monofile
Flow Cell Focused laser beam Sheath Sheath Fluid Fluid Injector Tip Figure 3-9 Flow Cytometer – Hydrodynamic Focused Cell Monofile The dilution for the WBC optical count (WOC) is prepared in the lower right chamber (Figure 3-10) at 1:40 whole blood to sheath flow reagent. The vacuum valve and the injection fill valve are momentarily opened to permit the dilution to fill the sample reservoir line.
Page 58: Figure 3-10 Woc Sample Dilution - Injection System
To Vacuum Vac/Press Pressure Valve Regulator From Sheath Pressure Refill Pressure Intake Tank Sheath Waste Reservoir Sheath Laser Control Flowcell Beam Valve Sample Reservoir Bypass Dilution Vacuum Injection Valve Injection Pump Figure 3-10 WOC Sample Dilution – Injection System The system performs a logical series of steps to determine the classification of each cell on a cell-by-cell basis.
Page 59: Hemoglobin Determination (Hgb)
Hemoglobin Determination (Hgb) The ADVIA 70 method for determining hemoglobin is an adaptation of the standard manual cyanmethemoglobin method adopted in 1958 by the ad hoc panel for the Establishment of a Hemoglobin Standard of the Division of Medical Science of the National Academy of Science (U.S.A.).
Page 60: Mean Cell Volume Determination (Mcv)
The lysing reagent in the WBC/Hgb dilution produces a colorimetric reaction. Hemoglobin is released from the erythrocytes and combines with cyanide to form a stable compound. A measurement of the concentration of the hemoglobin derivative is made using the optical absorbency of 540-nanometer light. The hemoglobin measurement is compared to a reference measurement made prior to each test when the WBC cuvette is filled with diluent.
Page 61: Red Cell Distribution Width (Rdw)
Red Cell Distribution Width (RDW) The RDW is calculated from the RBC histogram by locating the 20 percentile and 80 percentile channels in the histogram. The separation of the channels is divided by the mean channel to express the width of the histogram as a percentage.
Page 62: Clog Detection
Patient Action Limits and Normal Ranges The ADVIA 70 Hematology System compares the measured results of each patient sample to expected Patient Ranges and Action Limits as defined by each laboratory.
Page 63 If no information is available for the sample, a default set of adult ranges based on female low values and male high values is used. The normal range criteria are added to the report at printing or reviewing. If additional information of sex and or age is added after the sample has been assayed, the report may be reprinted with the correct flagging.
Page 64 3-22 SECTION 3 — SYSTEM PRINCIPLES...
Page 65: Section 4 - Daily Operating Procedures
SECTION 4 — DAILY OPERATING PROCEDURES Supplies and Accessories..................2 Specimen Collection and Handling ..............2 Startup ........................3 System Checks......................3 Dry Startup ........................3 Normal Startup ......................4 Performing the Daily Quality Control Check ............5 Open-Tube Sampling ....................7 Running Samples in Sample Saver and Direct Patient Modes without a Worklist..7 Running Samples in Direct Patient Mode with a Worklist ..........
Page 66: Supplies And Accessories
Specimen Collection and Handling WARNING Read and understand all hazards limitations, and warnings contained in Appendix B before operating the ADVIA 70 Hematology System. This is imperative for your safety. IMPORTANT Venous blood samples should be collected with EDTA anticoagulant for all assays performed on the ADVIA 70 Hematology System.
Page 67: Startup
For detailed information about collection of whole blood samples by venipuncture, refer to Procedures for the Collection of Diagnostic Blood Specimens by Venipuncture (H3-A2) published by the National Committee for Clinical Laboratory Standards. Startup System Checks • Check for sufficient reagent levels. •...
Page 68: Normal Startup
Normal Startup 1. If the Wake Up function is not being used on the system, begin daily operation by pressing the analyzer power switch and turning the computer on. If the system is equipped with an autosampler, turn on the autosampler power at this time.
Page 69: Performing The Daily Quality Control Check
4. When the second background count is completed, the system displays the results and checks them for acceptability. Acceptable results for the background count are: • WBC <= 0.3 • RBC <= 0.05 • Hgb <= 0.2 • Hct <= 0.2 •...
Page 70 4. Prepare control material as directed in the control package insert. When the green indicator light to the left of the metal sample probe is illuminated, introduce the appropriate control by immersing the sample probe into the mixed control vial. Press the start pad on either side of the probe to aspirate the control.
Page 71: Open-Tube Sampling
Open-Tube Sampling Figure 4-3 Run Menu Running Samples in Sample Saver and Direct Patient Modes without a Worklist 1. From the Main Menu, press to open the Run Menu (Figure 4-3). 2. From the Run Menu, press - Male or - Female to select the appropriate normal range.
Page 72: Section 4 - Daily Operating Procedures
4. When the green indicator light to the left of the metal sample probe is illuminated, carefully open the mixed sample vial, immerse the probe in the sample and press the start pad on either side of the probe. The indicator changes from green to white and remains illuminated until the sample is fully aspirated.
Page 73: Figure 4-4 Results Window
Figure 4-4 Results Window Figure 4-5 Worklist Menu SECTION 4 — DAILY OPERATING PROCEDURES...
Page 74: Running Samples In Direct Patient Mode With A Worklist
Running Samples in Direct Patient Mode with a Worklist Worklist mode is an operating option for laboratories that prefer to run patient samples in batches. This option allows the operator to enter patient data for up to 250 samples before processing the batch. 1.
Page 75: Figure 4-7 Add Patient Window
Figure 4-7 Add Patient Window If you press after NOTE: F1, Find Match By Name F2, Find Match By ID entering the ID number or name, the system searches the demographics database for a match. If a match is found, the data is displayed and confirmation is requested.
Page 76: Running Stat Samples With A Worklist
Closed-Tube Sampling The optional ADVIA 70 autosampler has the capacity for closed tube sampling of up to 30 tubes in a batch. The ADVIA 70 Autosampler is equipped with a feature called Auto- NOTE: Recount.
Page 77 3. From the Edit Worklist window, press to add a sample carousel. 4. Enter the patient ID or name and press to locate the demographic information for the patient. If a match is located, verify that all information is correct. If the information is incorrect or no match is located, enter the full information.
Page 78: Using The Autosampler With A Worklist: Barcode Reader
(See page 15 for information on stat samples.) Using the Autosampler without a Worklist (Barcode Reader Required) The ADVIA 70 Autosampler can be used for patient sampling without using the worklist: 1. Load the autosampler carousel with the patient samples to be analyzed. Place the samples in consecutive positions starting with the first position.
Page 79: Running A Stat Sample In Autosampler Mode
At the completion of the daily workload the ADVIA 70 Hematology System is ready for shutdown. SHUTDOWN is an important part of the daily maintenance for the system. If the ADVIA 70 autosampler is being used with the system, it is imperative that the autosampler sampler be on during the shutdown process.
Page 80: Shutdown Without Wake Up
Main Menu). 2. Press to begin the shutdown process. The system delivers ADVIA 70 KLEEN to the parts of the analyzer that contact blood. Cleaning solution remains in the lines, thus clearing any sample residual and preparing the unit for the next day.
Page 81: Section 5 - Data Archive
System Log........................2 File System Description Data Archive The ADVIA 70 system computer organizes sample information to optimize retrieval. The primary file system is a Microsoft Access relational database that indexes the Patient ID, Patient Name, and Sample Sequence Number. Additional information such as date of birth, sex, and doctor is in the table.
Page 82: Maintenance Log
Maintenance Log The system maintains a log of all activities related to the required or special maintenance of the analyzer. This file is tied to the sequence number of the next sample to be filed. It is possible to analyze a sequence of events and determine the relationship of a maintenance event to sample assays.
Page 83: Section 6 - Datalog
SECTION 6 — DATALOG General ........................2 Opening the Datalog.....................2 Searching the Datalog ..................3 Searching by Sequence Number................. 4 Searching by Patient ID Number ................. 5 Searching by Patient Name ..................6 Displaying Results....................7 Changing the Patient ID ..................8 Transferring Data ....................9 Printing Data ......................9 SECTION 6 —...
Page 84: General
General On the ADVIA 70 Hematology System, the Datalog stores all results, including those of patients, background counts, and controls. The Datalog consists of a demographics database and a group of 50,000 results files in flow cytometry standard format (.FCS), including histogram data, scattergram data, raw counts, and supervisory data.
Page 85: Searching The Datalog
From the Datalog Menu you can: find sample results F1 - change the patient ID of the selected sample F3 – change or add comments to the selected sample F4 - display the results screen for the selected sample F5 - accept or reject the selected sample results F6 - transfer a selected sample data range...
Page 86: Searching By Sequence Number
Searching by Sequence Number 1. From the Datalog Menu, press to open the Datalog Search window (Figure 6-2). 2. From the Search Menu, press to open the Search by Sequential # box (Figure 6-3). Enter the sequence number and then click .
Page 87: Searching By Patient Id Number
Searching by Patient ID Number 1. From the Datalog Menu, press to open the Datalog Search window. 2. From the Search Menu, press to open the Search by ID Number box (Figure 6-4). Enter the ID number and then click .
Page 88: Searching By Patient Name
Searching by Patient Name 1. From the Datalog Menu, press to open the Datalog Search window. 2. From the Search Menu, press to open the Search by Last Name box (Figure 6-5). Enter the sequence number and then click the .
Page 89: Displaying Results
Displaying Results To display results from the Datalog 1. With one or more entries highlighted on the sample list of the Datalog Menu, press . The results will appear in the Results window, (Figure 6-6). 2. When the Results window is open, multiple options are available. You can: •...
Page 90: Changing The Patient Id
Changing the Patient ID 1. With the sample you want to change highlighted on the sample list of the Datalog Menu, press to open the Change ID box (Figure 6-7). 2. Enter the new ID number and click . The system displays the updated information in the Datalog.
Page 91: Transferring Data
3. Press to transfer the data for the range of samples to the LIS. Printing Data The ADVIA 70 Hematology System provides several options for printing data contained in the Datalog. Two basic printing formats are available: a landscape tabular presentation...
Page 92 To print the Datalog, press from the Datalog Menu to open the Datalog Print window (Figure 6-8). The following options are available: Press to print data in a landscape, F1 Print Listing by Sequence Number - tabular listing with multiple results on a page. This option prints a compact log of activity with complete accounting of all machine cycles, including controls, background counts, and rejected patient samples.
Page 93: Section 7 - Calibration Procedures
The flow cytometer must be primed and clear of bubbles. When to Calibrate The ADVIA 70 Hematology System is calibrated at the factory for size accuracy, electronic counting accuracy, and sample volume measurement accuracy. To verify that calibration, the calibration procedure described here must be used upon installation.
Page 94: How To Calibrate The System
The ADVIA 70 Hematology System is equipped to monitor red cell parameters using X values as a cross check of commercial quality control materials and calibration. A significant change in X values may indicate calibration is required. See Section 8 - Quality Control.
Page 95: Figure 7-2 Calibration Run
3. From the Main Menu window, press to open the Calibration Menu (Figure 7-1). Make sure that MCV appears in the Mode box in the lower right corner. Press to select MCV mode if necessary. 4. From the Calibration Menu, press , Run to open the Calibration Run window (Figure 7-2).
Page 96: Figure 7-3 Calibration Summary Window
7. After seven runs have been completed with no system alerts, press return to the Run Menu. Press to exit the Run Menu and open the Calibration Summary window (Figure 7-3). The system calculates results for each parameter, evaluates them against acceptable limits, and displays them for each parameter.
Page 97 F3 Manual Calibration - Laboratories with large test volumes and with an experienced technologist may wish to use X data to trim the calibration factors and use the ADVIA 70 TESTpoint Calibrator values to verify the analyzer calibration. To trim a calibration factor, enter the calibration factors using the key to move from factor to factor.
Page 98 SECTION 7 — CALIBRATION PROCEDURES...
Page 99: Section 8 - Quality Control
SECTION 8 — QUALITY CONTROL General ........................2 Quality Control System Organization ..............3 Selecting the Active Control Lot................4 Adding Controls to the System ................5 Setting Up a Quality Control File Using a Disk ............5 Setting Up a Quality Control File Manually ..............6 Deleting a Control Lot ..................7 Editing a Control File....................7 Reviewing Quality Control Results ..............8...
Page 100: General
Stabilized control material and Bull’s moving average algorithm are two independent means by which the ADVIA 70 Hematology System allows you to monitor performance. The acceptable variation in measured results of control material is dependent on several factors including instrument precision, instrument stability, control material stability, and reagent variation of different lot numbers or batches.
Page 101: Quality Control System Organization
Figure 8-1 Quality Control Menu Quality Control System Organization The ADVIA 70 Quality Control system is designed to make handling quality control data simple and straightforward. When the QC Menu is activated, the software guides the operator through each step with clarity and precision.
Page 102: Selecting The Active Control Lot
Selecting the Active Control Lot 1. From the Quality Control Menu, press to open the Control Menu (Figure 8-2). This menu provides a list of the controls on file. From this list you can select a control lot simply by clicking it. Your selection will be highlighted. Figure 8-2 Control Menu 2.
Page 103: Adding Controls To The System
Adding Controls to the System From the Control Menu, press to open the Add Control window (Figure 8-3). This menu lets you establish new QC files. Figure 8-3 Add Control Window Setting Up a Quality Control File Using a Disk Bayer control materials come with a 3.5 inch floppy disk containing the assay sheet data.
Page 104: Setting Up A Quality Control File Manually
Setting Up a Quality Control File Manually 1. From the Add Control window, press to open the Add Control - Manual window (Figure 8-4). Figure 8-4 Add Control – Manual Window 2. Enter the necessary data. You can press the key to move from line to line.
Page 105: Deleting A Control Lot
Figure 8-5 Add Control – Low Window Deleting a Control Lot From the Control Menu (Figure 8-2), select the lot to be deleted by clicking it in the list. Press to delete the control. If the control is currently selected as the active control, you may not delete it.
Page 106: Reviewing Quality Control Results
Figure 8-6 Edit Control – Low Window Reviewing Quality Control Results The ADVIA 70 Hematology System allows maintenance of all Quality Control records within the system for review and/or printing at any time. Quality control data in the Datalog is retained for fifty thousand machine cycles, which in normal installations running one hundred samples per day, would result in retention for eighteen months.
Page 107: Figure 8-7 Levy-Jennings Window
Figure 8-7 Levy-Jennings Window 4. Select the month to view from the date range by pointing and clicking the entry in the list. Press to view the Levy-Jennings chart (Figure 8-8). Press to navigate among the parameters. For a printed report, press Press for additional selections.
Page 108: Quality Control Results
Figure 8-8 Levy-Jennings Chart Quality Control Results 1. To review QC results quantitatively, press from the Quality Control Menu (Figure 8-1). 2. Select the lot number you want for the list, and then select the control level. Press for the low control, for the normal control, or for the high control.
Page 109: Figure 8-9 Control Data Window
Figure 8-9 Control Data Window Figure 8-10 Data Files Window SECTION 8 — QUALITY CONTROL 8-11...
Page 110: Submitting Control Data By Disk
5. Press to review the data in tabular form. The Data Files window (Figure 8-10) displays the selected QC results. QC sample errors, such as accidental sampling of the wrong control, can be corrected here. It is not possible to edit the values measured by the system, but a specific sample may be marked for exclusion from reports and calculation if necessary Highlight the desired sample by pointing and clicking the entry.
Page 111: Figure 8-12     X
Figure 8-11     X Menu Figure 8-12     X Target Window SECTION 8 — QUALITY CONTROL 8-13...
Page 112: Establishing  X B
Establishing     X Target Values to open the X 1. From the Quality Control Menu (Figure 8-1), press Menu (Figure 8-11). 2. From the X Menu press F4 to access the Enter X Target window (Figure 8-12). Reference values have been entered into the file.
Page 113: Viewing Or Printing  X B Graphics
Figure 8-13     X Chart Window Viewing or Printing     X Graphics To view X from the X Menu. The X graphics, press Chart (Figure 8- 13) will appear. to print X Press graphics. Each data point on the graphs represents one batch of 20 patient results.
Page 114: Figure 8-14     X
Figure 8-14     X Review Samples Window Figure 8-15     X Review Batch Window 8-16 SECTION 8 — QUALITY CONTROL...
Page 115: Section 9 - Maintenance
SECTION 9 — MAINTENANCE General ........................2 Maintenance Log....................3 Adding an Event to the Maintenance Log..............3 Adding or Editing a Comment in the Maintenance Log..........4 Printing the Maintenance Log ..................4 Reagents........................5 Changing Reagents..................... 5 Priming Reagent Lines ....................7 Monthly or Pre-Calibration Cleaning..............7 Cleaning the Slide Valve....................
Page 116: General
All maintenance functions are performed from the maintenance menu. From the Main Menu, press to select the Maintenance Menu (Figure 9-1). The ADVIA 70 software provides a series of steps to assist the operator NOTE: with the routine maintenance required to keep the analyzer operating properly.
Page 117: Maintenance Log
Figure 9-1 Maintenance Menu Maintenance Log The system maintains a log of maintenance, calibration, and quality control events. This record is automatically collected as the analyzer is used. Events such as replacement of reagents, cleaning of the apertures and slide valve, startup, shutdown, and instrument repairs are filed in sequence and synchronized with the Datalog to record all machine cycles and events.
Page 118: Adding Or Editing A Comment In The Maintenance Log
Figure 9-2 Maintenance Log Adding or Editing a Comment in the Maintenance Log 1. Select the event by clicking it in the Maintenance Log. 2. With the event highlighted, press to open the Edit Comment box. 3. Edit or enter the desired text and then click to save the change.
Page 119: Reagents
Reagents Figure 9-3 Replace Reagents Window Changing Reagents 1. When replacement of a reagent is necessary, return to the Main Menu and press to open the Maintenance Menu 2. Press to choose reagents, and then press F2 to open the Replace Reagents window (Figure 9-3).
Page 120: Figure 9-4 Change Reagents Window
Figure 9-4 Change Reagents Window Figure 9-5 Prime Reagents Window SECTION 9 — MAINTENANCE...
Page 121: Priming Reagent Lines
Monthly or Pre-Calibration Cleaning Prior to any calibration or at least once a month, the operator should perform the following maintenance procedures on the ADVIA 70 Hematology System. WARNING Take proper safety precautions when performing maintenance on the system.
Page 122: Figure 9-6 Preventive Maintenance
Figure 9-6 Preventive Maintenance 6. Clean the front pad of the slide valve with deionized water using a squirt bottle or a syringe. Squirt the deionized water through both loops of the front pad and make sure the loops are free of debris. NOTE Warm water will dissolve salts more effectively than cold water.
Page 123: Cleaning The Wbc Aperture (No Disassembly)
14. Press . The instrument performs a refilling cycle. 15. Return to the Run Menu and perform five background counts. The background count values should be within acceptable limits. If counts are only slightly above acceptable levels, perform additional background counts until values are acceptable.
Page 124: Semi-Annual Maintenance
Semi-Annual Maintenance In addition to the standard monthly cleaning of the slide valve and WBC aperture, perform the following cleaning procedures every six months. When performing the semi-annual maintenance, it is not necessary to perform the WBC aperture bleaching procedure because a more thorough version is included here. Cleaning the Apertures (Disassembly Required) Use he following manual method of cleaning RBC and WBC apertures before calibration or when an obstruction cannot be removed by backflushing the...
Page 125: Annual Maintenance
8. Prepare a 20% solution of household bleach and deionized water. Remove the tubing attached to the WBC aperture. This allows the aperture to be removed from the electrode. Place the apertures in the bleach solution and make certain they are completely immersed for 15 minutes. Do not place O- rings in this solution.
Page 126 9-12 SECTION 9 — MAINTENANCE...
Page 127: Section 10 - Troubleshooting
SECTION 10 – TROUBLESHOOTING General ........................2 Overview of Troubleshooting................2 Alert or Symptom....................2 Functional Alerts ......................2 System Message Alerts ....................3 Hematology Flags......................7 SECTION 10 – TROUBLESHOOTING 10-1...
Page 128: General
General This section contains information that is helpful in locating and correcting problems that may occur during operation of the ADVIA 70 Hematology System. This section is not a complete service manual and is limited to items that are readily diagnosed and corrected by the user of the system. Routine maintenance is found in Section 9 —...
Page 129: System Message Alerts
System Message Alerts stop system operation. They are triggered by problems with basic system functions that are necessary to make any reliable measurement. ADVIA 70 Diluent – Indicates that the diluent reservoir did not refill in the prescribed time. The internal reservoir is connected to the external cube of diluent through a check valve.
Page 130 However, these factors are electronic or mechanical in nature and require service intervention to correct. ADVIA 70 Lyse- Indicates that there is air in the analyzer lyse path. There are several different conditions that can generate a Lyse alert. The most common of these conditions is an empty lyse bottle.
Page 131 The most common cause of the alert is an empty sheath flow reagent cube. Check the pickup tube in the sheath flow reagent cube to be sure that it is installed all the way to the bottom of the cube. Check for crimped or mashed tubing. There are other factors that can contribute to this alert.
Page 132 Internal Link - Indicates that the internal communication link is not responding to commands. Internal sections of the ADVIA 70 analyzer receive instruction from the Sequencer PCB via a dedicated communication network. The system measuring process is controlled by the sequencer circuit board. It communicates with the fluid control valves, pumps, sample valve, and optical processor over an internal link.
Page 133: Hematology Flags
Pierce Failure - Indicates that the needle failed to perform its task in the allotted time. Time Out - Indicates that the sample was not aspirated in the allotted time. Batch Abort - Indicates that the processing of the current sample batch was interrupted.
Page 134: Figure 10-1 Normal Fs-Wa
• At least one population count is too low in value for verification of separation. If the DIFF flag is present, the sample results must be reviewed. WBC - The WBC flag indicates that a clinically significant difference exists between the WBC impedance count (WIC) and the WBC optical count (WOC). The reported WBC count is the WIC.
Page 135: Figure 10-4 B Flag Scattergram
B - The B flag usually implies blasts. It is triggered by one or more of the following: • Distortions of the monocyte cluster. In Figure 10-4, the monocyte cluster (shown in red) is elongated causing the standard deviation of the monocytes on the FS axis to exceed the trigger point.
Page 136: Figure 10-6 L Flag Scattergram
Figure 10-6 L Flag Scattergram Figure 10-7 L Flag Scattergram In Figure 10-1, the lymphocyte cluster is essentially round and compact. This is typical of normal lymphocytes that are cleanly separated from other cell types. In Figures 10-6 and 10-7, the lymphocyte populations are elongated or dispersed. Figure 10-6 is and example of NRBCs that influence the lymphocyte region.
Page 137 APPENDIX A — SYSTEM SPECIFICATIONS Operating Characteristics ..................2 Parameters Reported ....................2 Scientific Principles...................... 3 Sampling Features....................3 Volume Required for Each Analysis................3 Dilution Ratios ......................3 Cell Counting Aperture Size..................3 Cycle Time........................3 Performance Specifications.................4 Computer Hardware....................5 Processor and Memory....................5 Display.........................
Page 138: Appendix A - System Specifications
Operating Characteristics Parameters Reported PARAMETER ABBREVIATION UNIT Measured parameters White blood cell concentration cells/µL Red blood cell concentration cells/µL Hemoglobin concentration g/dL Platelet concentration cells/µL Derived from histograms Mean red cell volume Red cell distribution width Mean platelet volume Platelet distribution width Derived from scattergrams Neutrophil percent Neut%...
Page 139: Scientific Principles
Scientific Principles Electrical impedance for cell counting and RBC and Plt sizing. Multi-Dimensional Optical Scattering (MDOS) and absorbance for white cell differential. Optical absorbance of cyanmethemoglobin for hemoglobin: Wavelength: 540 nm Bandwidth: 8 nm Sampling Features Volume Required for Each Analysis Normal mode 180 µL Sample saver...
Page 140: Performance Specifications
The Plt low range is calculated for 20 or more sequential samples of abnormal low control material. When tested with a commercial linearity material having no interfering substances, the deviation of ADVIA 70 Hematology System is less than the greater of the values in the table above. APPENDIX A — SYSTEM SPECIFICATIONS...
Page 141: Computer Hardware
Two RS232/C Serial Ports – LIS, (Optional MODEM) • One parallel printer port, Centronics output • Ethernet 10 base T – link analyzer to computer (TCP/IP) • Control connector – ADVIA 70 Autosampler (Optional equipment) Printer (optional equipment) Minimum Requirements: • Windows 2000 compatible •...
Page 142: Software Characteristics
Software Characteristics Operating Systems Microsoft Windows 2000 Microsoft MSDOS Software Features Patient results • All math calculations performed automatically • Multiple language options for user interface • User-definable normal ranges and action limits for age and sex Patient or control results •...
Page 143: Alerts
RBC/WBC Flow Time • Vacuum • Hgb Sensor System Message Alert: Analyses stop • ADVIA 70 Diluent Out of Diluent • ADVIA 70 KLEEN Out of cleaner • ADVIA 70 Lyse Out of lyse • ADVIA 70 Sheath Out of sheath •...
Page 144 • External Link • Dilutor Error • Slide valve Error • Wash block Error • Injector Error • Aspirator Error • Sampler Waste Error • Cap Piercer Error • Sampler Carousel Error • Sampler Pump Error Hematology Flags: Results not validated and flags appear on report •...
Page 145: Physical Characteristics
ADVIA 70 Diluent • ADVIA 70 Lyse • ADVIA 70 KLEEN • ADVIA 70 Sheath • ADVIA 70 TESTpoint Controls • ADVIA 70 SETpoint Calibrator Power Requirements Input requirements 100/120V~ 2.0A 50/60Hz 200/240V~ 1.0A 50/60 Hz Maximum consumption 200 Watts...
Page 146: Regulatory Compliance
Regulatory Compliance United States UL 3101-1, 21 CFR 1040 Canada CSA 1010-1 Europe EN 61010-1, EN 60825-1 EN Installation Category 2 EN Pollution Level 2 A-10 APPENDIX A — SYSTEM SPECIFICATIONS...
Page 147: Appendix B - Operational Hazards, Precautions, And Limitations
APPENDIX B — OPERATIONAL HAZARDS, PRECAUTIONS, AND LIMITATIONS General ........................2 Documentation......................3 Electrical Hazards....................3 Instrument Precautions..................3 Reagent Precautions ....................4 Maintenance Precautions..................4 Calibration Precautions..................4 Procedural Precautions and Limitations ............5 Results Limitations....................5 Limitations of the Hct Determination................6 Limitations of the Platelet Count .................. 6 Interpretation of Results ..................7 APPENDIX B —...
Page 148: General
To avoid damage to the eyes, never look directly at the laser beam or at its reflection from a shiny surface. During operation, the ADVIA 70 system functions as a Class I (Class 1) Laser Product pursuant to the United States Code for Federal Regulation, Title 21, Sub- chapter J, Part 1040 (and EN 60825-1).
Page 149: Documentation
ADVIA 70 laser assemblies. All field service procedures must be followed precisely. Documentation In the documentation for the ADVIA 70 Hematology System, all hazards are categorized as follows: WARNING Indicates the risk of personal injury or loss of life if operating procedures and practices are not correctly followed.
Page 150: Reagent Precautions
The ADVIA 70 Lyse reagent container must be positioned at the same counter level as the instrument to ensure correct solution flow rates. The ADVIA 70 Diluent, ADVIA 70 Sheath, and ADVIA 70 Kleen may be at or below the level of the instrument.
Page 151: Procedural Precautions And Limitations
ADVIA 70 Hematology System. The sample analysis process of the ADVIA 70 Hematology System is monitored throughout the measurement cycle. Events that impact the reliability of the analysis result in warnings to the operator. The system records all warnings issued in either the Datalog or the System Event Log.
Page 152: Limitations Of The Hct Determination
Some white blood cells are counted along with the red blood cell count. The ADVIA 70 Hematology System measures the volume of each cell counted as a red blood cell and totals the number for the hematocrit value. A very high white cell count may help produce an erroneously high hematocrit value.
Page 153: Interpretation Of Results
Low Plt values are also affected by the reagent background counts. The ADVIA 70 Hematology System is equipped with a 0.2µ absolute filter to remove contaminants from the diluent. The Plt background count is generally less than 2 x 10 K/µL.
Page 154 APPENDIX B — OPERATIONAL HAZARDS, PRECAUTIONS, AND LIMITATIONS...
Page 155: Appendix C - Bibliography
APPENDIX C — BIBLIOGRAPHY 1. Bessman, J.D.; (1977) Eythropoiesis during recovery from macrocytic anemia: macrocytes, normocytes, and microcytes. Blood 50:995-1000 2. Bessman, J.D. and Feinstein; (1979) Blood 53(2):288 3. Bessman, J.D. and Johnson, R.K.; (1975) Erythrocyte volume distribution in normal and abnormal subjects. Blood 46:369-379 4.
Page 156 19. ICSH; (1978) Recommendations for reference method for hemoglobinometry in human blood (ISCH Standard EP6/2: 1977) and specifications for international hemoglobincyanide reference preparation (ICSH Standard EP6/3: 1977) J clin Path 31:139-143. 20. Jones A. R., Twedt D.,Hellman R.; (1995) Absolute versus proportional differential leukocyte counts;...
Page 157: Appendix D - Abbreviations
APPENDIX D — ABBREVIATIONS The following abbreviations are used in this manual. Bas: basophil CRT: cathode ray tube, the computer monitor CV: coefficient of variation Eos: eosinophil EX: extinction FCS: flow cytometry standard format, the file format for database records FS: forward scatter Hct: hematocrit Hgb: hemoglobin...
Page 158 RDW: red cell distribution width SD: standard deviation SWA: super wide-angle scatter TOF: time of flow WA: wide-angle scatter WIC: WBC impedance count WOC: WBC optical count APPENDIX D — ABBREVIATIONS...

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