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Bayer HealthCare ADVIA 60 Operator's Manual

Bayer HealthCare ADVIA 60 Operator's Manual

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ADVIA® 60 Hematology System
Operator's Guide
Closed Tube Model
075D0002-01 Rev. A, 2003-09

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Summary of Contents for Bayer HealthCare ADVIA 60

  • Page 1 ADVIA® 60 Hematology System Operator’s Guide Closed Tube Model 075D0002-01 Rev. A, 2003-09...
  • Page 2 If the system is used in a manner differently than specified by Bayer HealthCare LLC, the protection provided by the equipment may be impaired. See warning and hazard statements.
  • Page 3 The LED stops blinking and the tube holder carriage moves down when the sampling is completed. Shutdown procedure 1. Perform a general cleaning/rinse cycle of the ADVIA 60 Hematology System using the STAND BY key on the front panel. This cycle lasts for approximately one (1) minute. The instrument will cycle into the STAND BY mode.

  • Page 5: Table Of Contents

    Table of Contents CHAPTER 1. INTRODUCTION ................... 1-1 1.1. INTENDED USE ..........................1-1 1.2. PRESENTATION ..........................1-2 1.3. OPEN TUBE AND CLOSED TUBE MODELS ..................1-2 1.4. NOTES ............................. 1-2 CHAPTER 2. INSTALLATION ..................2-1 2.1. INSPECTION ............................ 2-1 2.2. UNPACKING ............................. 2-1 2.3.
  • Page 6 4.3. STUDY OF GENERAL FLAGS ......................4-6 4.3.1. Platelet flags ..........................4-7 4.3.2. HGB flag ............................. 4-7 4.3.3. WBC Flags ..........................4-7 4.3.4. Comments on the flagging capabilities ................... 4-8 CHAPTER 5. DESCRIPTION ..................5-1 5.1. INSTRUMENT ........................... 5-1 5.1.1. Front panel and command keys ....................5-1 A - Using the keyboard ........................
  • Page 7 7.5.4. QC print targets ......................... 7-16 7.5.5. QC statistics ..........................7-17 7.5.5.1. Select statistics ........................7-17 7.5.5.2. Select level ..........................7-17 7.5.6. QC Graphs ..........................7-18 7.5.6.1. Select graphs ........................7-18 7.5.6.2. Select level ..........................7-18 CHAPTER 8. INSTRUMENT CONFIGURATION ............8-1 8.1. RESULTS OPTIONS ........................8-1 8.1.1.
  • Page 8 9.1.3.1. Backflush ..........................9-2 9.1.3.2. Drain chambers ........................9-2 9.1.3.3. Prime reagents ........................9-2 9.1.3.4. Concentrated cleaning ......................9-3 9.1.3.5. Mechanical checks ....................... 9-4 9.1.3.6. Cycle functions ........................9-6 9.1.3.7. Technician functions ......................9-6 9.1.3.8. Automatic cleaning ......................9-6 9.1.4 Disposal of System Waste and Supplies .................. 9-6 9.2.

  • Page 9: Chapter 1. Introduction

         (Closed Tube) system is a fully automated (Microprocessor controlled) hematology analyzer used for the in vitro diagnostic testing of whole blood specimens. ADVIA 60- CT16 - WBC, LYM%, LYM#, MON%, MON#, GRA%, GRA#, - RBC, HGB, HCT, MCV, MCH, MCHC, RDW, PLT, MPV, and 3 distribution curves: WBC, RBC, PLT.

  • Page 10: Presentation

    1.4. NOTES Bayer HealthCare retains the right to make changes to the instrument and this document. Your local technical support provider or distributor will provide the latest revision of this document. No part of this document may be copied or reproduced in any form or by any means without prior written consent of Bayer HealthCare.

  • Page 11: Chapter 2. Installation

    CHAPTER 2. INSTALLATION 2.1. INSPECTION A thorough inspection is performed prior to the release of an ADVIA 60- Hematology System. It is important to verify receipt of all parts. Notify any descrepancies with the carrier. As instructed, the installation procedures must be followed in the order listed below.

  • Page 12: Package Contents

    O ring 6 mm x 1.5 mm FAA 036 A O ring 0.74 mm x 1.02 mm FAA 054 A ADVIA 60 common installation kit XEA 312 A Table 2.1 - The ADVIA 60- common installation kit (XEA 312 A) includes :...

  • Page 13: Working Conditions

    2.4.2. Location ADVIA 60- should be placed on a clean and level table or work station. Please note that ADVIA 60- printer and reagents weigh approximately 30 kilograms (66 lbs). Avoid exposure to sunlight. Proper ventilation requires that a space of at least 20 cm (8 inches) must be left behind the apparatus.

  • Page 14: Connection Check

    2. INSTALLATION Push the black plastic carriage locking clip as far as possible to the left and place the sample needle carriage as far forward as possible to the right-hand side. Check that the aspiration needle is not bent and make sure it is in its upper position. 1 - Carriage locking clip 2 - Sample needle carriage 3 - Needle...

  • Page 15: Reagent Pack Connections

    : they should be 1 Amperes, 220 Volts Slow-Blow. Diag.2.8 2.6. REAGENT PACK CONNECTIONS The ADVIA 60 Hematology System TIMEPAC ® Reagents includes the entire set of reagents in a "Pack" and is able to receive the waste liquids. Three soft pockets contain the 3 reagents sysDIL ®...

  • Page 16: Reagent And Waste Handling Precautions

    The ADVIA 60- responds to the UL 3101 norm. Refer to the Declaration of Conformity Statement for details. System performance is guaranteed by Bayer HealthCare under the following condi- tions only: - services and repairs are provided by your local technical support provider or distributor - the electrical supply of the laboratory follows the national or international regulations - the system is operated under the following instructions.

  • Page 17: Connection

    Lock the connector in place by tightening the 2 screws on each end of the connector to the ADVIA 60- . Attach the other end of the cable to the printer and lock the printer connector in place by the means of the 2 clips located on the connector itself.
  • Page 18 2. INSTALLATION From the MAIN MENU, move the cursor to the function SERVICE and press ENTER. The service menu is displayed : SERVICE > 2 DRAIN CHAMBER HH : MM 3 PRIME REAGENTS Move the cursor to PRIME REAGENTS and press the ENTER key. Select the function CHANGE PACK and follow the instructions given by the LCD in order to install the pack.

  • Page 19: Chapter 3. Specifications

    31°C decreasing linearly to 50% relative humidity at 40°C. - Smart Card option : * Reader : GCI 400 - ADVIA 60 SETpoint Calibrator memory card : - GFM 2K - Patient memory card : - MCOS 24K (capacity : 60 CBCs)
  • Page 20 3. SPECIFICATIONS - Storage capacity : Number of QC available # of QC Aspirations/day QC8P card QC16P card Table 3.1 - Hemoglobin : * HGB/WBC chamber, LED 550 nm. - Size of apertures : * WBC = 80 µm * RBC/PLT = 50 µm - Final dilutions : * WBC = approximately 1/250 * RBC / PLT = approximately 1/15000...
  • Page 21 3. SPECIFICATIONS - Reagent pack * Total capacity : 4.2 liters - Measuring principles: * WBC.RBC.PLT = Impedance change * Hematocrit = Numeric integration * HGB = Cyanmethemoglobin method (550 nm) - Barcode reader option: * EAN 8, EAN 13, C 39, C 128, ITF (2/5), CODABAR, STF, C 93 with or without checksum.

  • Page 22: Expected Values

    3. SPECIFICATIONS - Carryover : Carry-over was tested by analyzing samples with high concentrations of WBC's, RBC's, HGB and PLT's. Each sample was run in triplicate, followed by three background cycles. The % carryover is calculated using the following formula : Background 1 - Background 3 Carryover = --------------------------------------------- X 100...
  • Page 23 3. SPECIFICATIONS - Accuracy : Approximately 200 patient specimens were analyzed on the ADVIA 60- and the ADVIA ® 120 Hematology Systems at three different locations. The following table summarizes the data: SITE 1 SITE 2 SITE 3 PARAMETER WBC (x 10 0.996...

  • Page 24: Reagent Specifications

    Physio-chemical properties : Boiling point : About 100°C, pH : neutral. 3.2.2. Lyse : sysLYSE (1 x 200 mL) For in vitro diagnostic use as an eythrocyte-lysing agent for leukocyte counting, differentiation, and hemoglobin determination on the ADVIA 60 Hematology system. Composition : · Potassium cyanide, 0.03%.

  • Page 25: Detergent : Sysklen

    3. SPECIFICATIONS 3.2.3. Detergent : sysKLEN Function : For in vitro diagnostic use in hte cleaning of the Advia 60 Hematology system. Composition: Organic buffer, < 0.2%. Physio-chemical properties: Boiling point : around 100°C, pH = 9.7 ± 0.2 at 20°C.

  • Page 26: Caps Of The Sampling Tubes

    3. SPECIFICATIONS 3.3.2. Caps of the sampling tubes Some caps of the sampling tubes are more adapted to "cap piercing" sampling systems. Plastic caps cannot be used. Rubber caps can be of different quality materials. Use the best quality materials in order to avoid any rubber particles entering the sample tube when the cap is pierced. It is also recommended to use caps specially designed to avoid any blood retention in the upper part of the cap.
  • Page 27 3. SPECIFICATIONS Following the manual differential white blood cell count, the WBC assay value must be corrected for the presence of nucleated red blood cells. The formula utilized for correcting the WBC parameter, when nucleated red blood cells are present, is: counted WBC X 100 CORRECT WBC: -------------------------------------...
  • Page 28 3. SPECIFICATIONS HGB (Hemoglobin): Turbidity of the blood sample - Due to any number of physiologic and/or therapeutic factors may produce falsely elevated HGB results. To obtain accurate hemoglobin results when increased turbidity of the blood sample occurs, determine the cause of the turbidity and follow the appropriate method below : 1.
  • Page 29 3. SPECIFICATIONS RDW (Red Blood Cell Distribution Width): The red blood cell distribution width is a function of the RBC count. The red blood cell dilution contains all of the formed elements in the blood : erythrocytes, leukocytes and platelets. During the counting of the erythrocytes (Red Blood Cells) platelets are not included in RBC count since their size falls below the minimum threshold.
  • Page 30 3. SPECIFICATIONS Agglutinated erythrocytes - May trap Platelets, causing an erroneous MPV result. The presence of agglutinated erythrocytes may be detected by observation of the abnormal MCH and MCHC values and by careful examination of the stained blood film. Chemotherapy - May also affect the sizing of PLTs. CAUTION: Blood samples collected in EDTA will not maintain a stable Mean Platelet Volume.

  • Page 31: Chapter 4. Technology

    CHAPTER 4. TECHNOLOGY 4.1. MEASUREMENT PRINCIPLES 4.1.1. RBC / WBC / PLT detection principles The counting principle used for red blood cells (RBC), white blood cells (WBC), and platelets (PLT) is based on the variation in impedance generated by the passage of cells through a calibrated microaperture.
  • Page 32 7 - Each type of cell (WBC, RBC, PLT) is analyzed by the microprocessor which also handles the cell distribution (histograms). 8 - To count the platelets, the ADVIA 60- uses high performing electronics, which avoids the use of complex hydraulic systems for the elimination of faulty impulses generated at the rear side of the aperture.

  • Page 33: Hemoglobin Measurement Principle

    3 - The result is given with the units set up in Section 8 "Instrument Configuration". 4.2. CELL DISTRIBUTION STUDY ADVIA 60- carries out volumetric distributions (histograms) for WBC and RBC on 256 analysis channels, and 128 channels for PLT with the following measuring range: * WBC = approximately 30 to 460 fL.

  • Page 34: Diluent And Lysing Action

    4.2.1.3. Volumetric study After the differential lysing action, ADVIA 60- analyzes the heights of each impulse, coming from the aperture and ranked in the 256 counting channels. A curve is obtained with number of cells on the y-axis and cell volume on the x-axis.

  • Page 35: Distribution Of Red Blood Cells

    4. TECHNOLOGY 4.2.2. Distribution of Red Blood Cells The study of the distribution of RBC detects erythrocyte anomalies linked to anisocytosis. A Red Cell Distribution Width (RDW) will enable you to follow the evolution of the width of the curve in relation to the cell number and average volume. K SD With System constant...

  • Page 36: Study Of General Flags

    4. TECHNOLOGY 4.3. STUDY OF GENERAL FLAGS With the print-out of results the following general flags may occur : following either WBC, RBC, HCT or PLT indicates that the system, analyzed the sample three times but that all three counts differed and were outside the systems precision limits. The result should be verified by repeating the sample or checked according to one of the laboratory reference methods.

  • Page 37: Platelet Flags

    If this suspicious flag occurs more than three consecutive times run the checkup procedure. 4.3.3. WBC Flags The ADVIA 60- has a system of WBC differential flags alerting the operator to the possible presence of pathological cells, abnormal volume distribution histograms or abnormal elevated populations such as in the case of the eosinophils and basophils.

  • Page 38: Comments On The Flagging Capabilities

    The lab operator can adjust the limit which triggers this flag. 4.3.4. Comments on the flagging capabilities All anomalies and/or abnormal distributions signaled by the ADVIA 60- should be verified manually for the presence of pathological elements. As a result of the differential resistance of cytoplasmic membranes in the different cell types, pathological elements can be found in a number of different zones.

  • Page 39: Chapter 5. Description

    Door to pneumatic part Piercing carriage door Front panel Diag.5.1 1 - ADVIA 60- Cover The instrument cover is fixed by the means of 5 screws. Before any attempt to remove the cover, open the pneumatic access door on the front of the system.

  • Page 40: B - Command Keys

    5. DESCRIPTION Diag.5.2 STARTUP key DELETE key STAND BY key ENTER key Identification Key (ID/SEQ) ESCAPE key Start analysis cycle key (START) Display scroll keys Numerical keyboard Cycle light indicators B - Command keys 1 - STARTUP key: When this key is pressed, a startup cycle including a cleaning and rinsing procedure is carried out.
  • Page 41 5. DESCRIPTION 5 - Numerical keyboard : keys from 0 to 9 allow the operator to enter the following figures : - Date - Calibration values - Laboratory limits - Patient number for analysis - Leukocytes differential flag values. These 2 keys pressed simultaneously will allow an automatic adjustment of the LCD.

  • Page 42: Rear Panel / Main Fuses

    5. DESCRIPTION 5.1.2. Rear panel / Main fuses Rear panel RS 232 computer connection Printer output ON/OFF switch F1,F2 Main fuses Main power socket Diag.5.3 Diag.5.4 5.1.3. Left side internal view Vacuum/pressure syringe Liquid electrovalve block 1 Dilution block Liquid electrovalve block 2 Diag.5.5 Page 5/4 075D0002-01...

  • Page 43: Front Internal View

    5. DESCRIPTION 5.1.4. Front internal view LCD display Keyboard Cycle light indicators Sampling needle carriage Start cycle key RBC chamber WBC chamber Spectrophotometer Piercing mechanism Tube holder switches Piercing carriage door switch Diag.5.6 075D0002-01 Page 5/5...
  • Page 44 5. DESCRIPTION Page 5/6 075D0002-01...

  • Page 45: Chapter 6. Startup And Sample Run

    CHAPTER 6. STARTUP AND SAMPLE RUN 6.1. STARTUP CHECKS 6.1.1. INSTRUMENT STARTUP Turn ON instrument by pressing the ON/OFF switch located on the rear panel. The display shows the following : PLEASE WAIT FOR 3 MIN ESCAPE : ESC Then the front panel LED turns from red to green to indicate that the initialization phase is completed. Wait for the end of the automatic startup cycle or press the STARTUP key, the instrument will perform a startup cycle and perform a blank cycle for a background count (an analysis cycle on reagent without any blood sample).

  • Page 46: Reagent Pack

    Sample collection should be done on venous blood by the means of vacuum or atmospheric sample collection tubes. It is possible to collect capillary blood into a microtainer with a minimum volume of 100 µL (for example in a pediatric lab.) and analyze this on the ADVIA 60- . EDTA is the recommended anticoagulent for analysis on the ADVIA 60- Samples should be processed as soon as possible, and within 6-8 hours of collection.

  • Page 47: Daily Quality Control/Calibration Verification

    6. STARTUP AND SAMPLE RUN 6.3. DAILY QUALITY CONTROL/CALIBRATION VERIFICATION Refer to your laboratory quality assurance program to ensure quality throughout the entire testing process. It is recommended that the system be controlled using Bayer TESTpoint Hematology Controls Low, Normal, and High (Prod. Nos. B03-4200-54, B03-4201-54, and B03-4202-54, respectively). Refer to the package insert supplied with the control for instructions for use.

  • Page 48: Us Mode Identification With Barcode Reader

    6. STARTUP AND SAMPLE RUN 6.3.1. US mode identification without barcode reader Press the ID/SEQ key of the front panel to enter the control ID. The identification menu is displayed : PAT. ID. ? : EXIT : ESC CURRENT: SAVE : ENTER The identification can be entered using 13 characters, letters or numbers.

  • Page 49: Standard Identification Mode

    6. STARTUP AND SAMPLE RUN 6.3.3. Standard identification mode Press the ID/SEQ key to enter the control Run #. The following menu is displayed: RUN #? : EXIT : ESC NEXT : SAVE : ENTER Enter the run number (from 1 to 9999) using the numeric keys of the front panel. Press the ENTER key to record the number (or the ESC key to save the displayed one) : A message "PLEASE CLOSE HOLDER DOOR"...

  • Page 50: Analysis

    6. STARTUP AND SAMPLE RUN 6.3.5. Analysis Install the sample tube in the tube holder and close the sample door to start the analysis if this mode has been selected or close the sample door and press the START key. Diag.

  • Page 51: Running Samples

    6. STARTUP AND SAMPLE RUN 6.4. RUNNING SAMPLES 6.4.1. Sample identification After completing the start up procedure, run a non pathological blood from the previous day, followed by the quality control analyses and then the sample analyses. 1 - Enter either the patient identification (US mode) or the patient run # (Standard mode). 2 - Install the sample tube in the tube holder and close the sample door to start the analysis if this mode has been selected or close the sample door and press the START key.

  • Page 52: Results

    6. STARTUP AND SAMPLE RUN 6.5. RESULTS When the analysis cycle is completed, results are displayed and printed out according to the setup of the instrument: 6.5.1. Displayed results The first group of parameters is displayed: MCHC 5.22 15.6 46.5 29.9 33.5 The second group of parameters can be accessed when moving the cursor to the top:...

  • Page 53: Result Printout

    6. STARTUP AND SAMPLE RUN 6.5.2. Result printout 1. US mode Diag. 6.4 On the result printout can be found: 1 - The sample identification that was entered by the operator. 2 - The sequence number. 3 - The STARTUP status. 4 - The PLT flags.
  • Page 54 6. STARTUP AND SAMPLE RUN 2. Standard mode Diag. 6.5 On the result printout can be found: 1 - The sample run # that was entered by the operator. 2 - The sequence number. 3 - The PLT flags. 4 - The CBC results. 5 - The WBC flags.

  • Page 55: Chapter 7. Calibration And Quality Control

    Calibration can be achieved in two different ways. 1 - Bayer SETpoint Calibrator (B03-4203-51) is used to calibrate the ADVIA 60- Hematology System.

  • Page 56: Smart Card Option

    7. CALIBRATION AND QUALITY CONTROL 7.2. SMART CARD OPTION When the instrument is equipped with a smart card reader proceed as follows. Install the card in the smart card reader. Make sure that the cursor is positioned on function AUTOCALIBRATION and press ENTER. Diag.

  • Page 57: Change Lot Number

    7. CALIBRATION AND QUALITY CONTROL 7.3.2. Change lot number CHANGE LOT # ? NO : ESC CURRENT : SETPOINT YES : ENTER The current lot number is displayed. If the lot number of the calibration blood has to be changed, press ENTER.

  • Page 58: Change Expiration Date

    7. CALIBRATION AND QUALITY CONTROL 7.3.3. Change expiration date The current expiration date is displayed. CHANGE EXP. DATE ? (DD.MM.YY) NO : ESC CURRENT : YES : ENTER If it is correct, press the escape key, the menu turns to the target values. If the expiration date needs to be changed, press ENTER, the following menu is displayed : EXP.

  • Page 59: Change Number Of Calibrator Samples

    NO : ESC CURRENT : YES : ENTER ADVIA 60- calibration may be performed using 3 to 11 sample aspirations. The autocalculation module performs statistics on these results in order to obtain the best calibration coefficients. In order to obtain the best calibration possible, it is recommended to run the calibration NOTE: blood a minimum of 5 times.

  • Page 60: Run Calibration

    7. CALIBRATION AND QUALITY CONTROL 7.3.6. Run calibration Prepare the calibrator according to the specific instructions (temperature, mixing, etc...). RUN CAL. ? NO : ESC YES : ENTER Press the ENTER key. The start calibration menu is displayed : START CALIBRATION # 1/X ESC TO EXIT CALIBRATION ENTER TO ASPIRATE...
  • Page 61 7. CALIBRATION AND QUALITY CONTROL A - Calibration passed : If the statistical figures are within the acceptable limits: - Coefficient of variation is within the limits given in Table 7.1 and, - The percentage difference between the target and the mean value is less than 20. The calibration passed and the results are printed out.
  • Page 62 7. CALIBRATION AND QUALITY CONTROL B - Calibration failed: If the statistical figures are not within the acceptable limits, the following menu is displayed: CALIBRATION FAILED !!! PRESS A KEY TO CONTINUE ... - Coefficient of variation is not within the limits given in Table 7.1 or, - The percentage difference between the target and the mean value is greater than 20.

  • Page 63: Calibration Coefficients

    7. CALIBRATION AND QUALITY CONTROL 7.4. CALIBRATION COEFFICIENTS Calibration can be achieved directly by changing the calibration coefficients when they are known. Move the cursor to function COEFFICIENTS and press ENTER. The following menu is displayed: COEFFICIENTS 1 CALIB. COEFF. HH:MM 2 PRINT COEFF.

  • Page 64: Print Coefficients

    7. CALIBRATION AND QUALITY CONTROL 7.4.2. Print coefficients From the COEFFICIENTS menu, it is possible to print the coefficient values. Move the cursor to function PRINT COEFF. and press ENTER. The printout of the coefficient values starts automatically. COEFFICIENTS DATE : 01/11/1997 TIME : HH : MM CURRENT : 0.97...

  • Page 65: Quality Control Program

    7. CALIBRATION AND QUALITY CONTROL 7.5. QUALITY CONTROL PROGRAM 7.5.1. Introduction The ADVIA 60- quality control program contains five different functions : 1 - AUTOMATIC - The function of this submenu is to allow the operator to analyze the commercial control bloods and store the results on the memory smart card.

  • Page 66: Qc - Automatic

    7. CALIBRATION AND QUALITY CONTROL 7.5.2. QC - Automatic From the QC menu, move the cursor to function AUTOMATIC and press ENTER. The AUTOMATIC menu will unfold step by step through the smart card insertion, the operator selection, the commercial control identification and lot, etc ... 7.5.2.1.

  • Page 67: Select Operator

    7. CALIBRATION AND QUALITY CONTROL List of the different messages : NEW QC : The smart card has not been used, it is the beginning of a new QC. XX QC RUN : xx QC are stored on this smart card and the index in the smart card and in the analyzer are identical.

  • Page 68: Run Commercial Control

    7. CALIBRATION AND QUALITY CONTROL 7.5.2.4. Run commercial control Prepare the commercial control according to the specific instructions (temperature, mixing, etc ... ). Install the calibrator tube in the correct holder position. Close the sample door to start the analysis if this mode has been selected or close the sample door and press the cycle button located on the front panel.

  • Page 69: Exiting Qc Automatic

    7. CALIBRATION AND QUALITY CONTROL 1 - ACCEPT: If the results are accepted they will be stored on the QC smart card and the display will return to the SELECT LEVEL. SELECT LEVEL > * 1 LOW BLOOD HH:MM 2 HIGH BLOOD It is possible to exit the QC or run another control level.

  • Page 70: Analysis

    7. CALIBRATION AND QUALITY CONTROL 7.5.3. Analysis This function ANALYSIS allows the operator to run a control as a normal analysis cycle but with specific LMG thresholds for QC blood (independant from the temperature). From the QC main menu, move the cursor to the function and press ENTER.

  • Page 71: Qc Statistics

    7. CALIBRATION AND QUALITY CONTROL 7.5.5. QC statistics The commercial control files can be printed for permanent records at any time. It is recommended to print the files at the end of each month. Each file printout includes the following information: File Name (blood level), Lot number of control, expiration date of control, date and time of print request, date and time of the run, operator and the data points for each stored quality control run, the reference means and upper and lower limits, the actual mean results of the quality controls runs, the 2 standard deviation value, and the...

  • Page 72: Qc Graphs

    ETC ..Diag. 7.9 7.5.6. QC Graphs The ADVIA 60- plots Levey-Jennings charts for each parameter of the quality control files stored. The Levey-Jennings chart will plot one point for every control data point stored. Beneath each chart, the Reference Mean, two SD value and the actual mean, two SD value and % CV are provided.
  • Page 73 7. CALIBRATION AND QUALITY CONTROL Using the UP or DOWN arrows select the commercial control level to print one set of graphs or all graphs automatically. Press ENTER and the following message appears: PRINTING QC RESULTS PLEASE WAIT... All graphs will be printed as shown in the example below. NOTE: QC graphs will be printed out even when values are equal to zero.
  • Page 74 7. CALIBRATION AND QUALITY CONTROL Page 7/20 075D0002-01...

  • Page 75: Chapter 8. Instrument Configuration

    CHAPTER 8. INSTRUMENT CONFIGURATION The ADVIA 60- has several operator options : - Specific laboratory limits. - Date and time formats. - Result format. - RS 232 options. - Special functions. These options can be configurated according to the operator needs through the SETUP function of the MAIN MENU.

  • Page 76: Reprint Results

    8. INSTRUMENT CONFIGURATION 8.1.1. Reprint results To reprint the results of the last sample in memory, move the cursor to function of the RESULTS menu and press ENTER. The results of the last sample is automatically reprinted with the date and time, the associated identification, sample run and sequence numbers, the possible flags and the histograms if their printout is selected.

  • Page 77: Printer Selection

    8. INSTRUMENT CONFIGURATION 8.1.4. Printer selection Four different printers and a no printout option can be selected from the RESULTS menu. Move the cursor to the function PRINTER and press ENTER. The PRINTER menu is displayed: PRINTER > * 1 RESERVED 1 HH:MM 2 RESERVED 2 Move the cursor to the required printer :...

  • Page 78: Print Limits

    8. INSTRUMENT CONFIGURATION 8.1.6. Print limits The laboratory limits can be printed out underneath each result when this option is selected. From the RESULTS menu, move the cursor to function and press ENTER. The PRINT LIMITS menu is displayed: PRT LIMITS >...

  • Page 79: Result High Limits

    8. INSTRUMENT CONFIGURATION Move the cursor next to the required parameter and press ENTER, the following menu (RBC for example) is displayed: RBC LOW ?: EXIT : ESC CURRENT : SAVE : ENTER Enter the required low value and press ENTER or press the ESC key to keep the current value. Move the cursor to the next required parameter and follow the same procedure.

  • Page 80: Flag Limits

    8. INSTRUMENT CONFIGURATION 8.2.4. Flag limits A - Platelet flag adjustment From the menu CHG LAB LIMITS, move the cursor to the function FLAGS and press ENTER. The flag menu is displayed: FLAGS LIMITS > 1 SCL <8.0> HH:MM 2 SCH <8.0>...

  • Page 81: Special Functions

    8. INSTRUMENT CONFIGURATION 8.3. SPECIAL FUNCTIONS These special functions accessible through a password allow the user to : 1 - Identify 4 users 2 - Change the password 3 - Choose the startup mode 4 - Adjust the cleaning frequency 5 - Print the internal setup of the instrument 6 - Set ON/OFF the cycle end audible signal 7 - Choose the identification mode...

  • Page 82: Change Password

    8. INSTRUMENT CONFIGURATION 8.3.2. Change password The use of a password is mandatory to access some important functions such as: - Changing the calibration factors. - Accessing the technician functions. - Changing the password. The original password is <123>. If the change is requested, move the cursor from the SPECIAL menu to function and press ENTER.

  • Page 83: Autocleaning Frequency

    8. INSTRUMENT CONFIGURATION 8.3.4. Autocleaning frequency An automatic cleaning involving a cleaner solution is normally carried out every 50 samples. The user has the possibilty to setup the automatic cleaning frequency according to the number of samples usually run in his laboratory. From the SPECIAL menu, move the cursor to the function CLEAN.

  • Page 84: Cycle End Audible Signal

    8. INSTRUMENT CONFIGURATION 8.3.6. Cycle end audible signal A cycle end audible signal (BEEP) can be set up with the SPECIAL menu. Move the cursor to the function BUZZER and press ENTER. The audible signal menu is displayed: BUZZER > * 1 ON HH:MM 2 OFF Move the cursor on the required option and press ENTER.

  • Page 85: Start Mode

    8. INSTRUMENT CONFIGURATION 8.3.8. Start mode The START MODE function allows the operator to choose between 2 different analysis starting modes: - In the automatic mode, the analysis can start directly when the operator closes the sample door, - In the manual mode, the analysis can start after closing the sample door, when the operator presses the START cycle key.

  • Page 86: Change Time

    8. INSTRUMENT CONFIGURATION 8.4.1. Change time Move the cursor to the function and press ENTER. The CHANGE TIME menu is displayed: NEW TIME (HH.MM) ? : EXIT : ESC CURRENT : SAVE : ENTER Enter the required time in the format HH.MM and press ENTER. The new time is recorded. 8.4.2.

  • Page 87: Host Options

    The ADVIA 60-CT has to be setup according to the external computer specifications. The following functions have to be used by your laboratory computer specialist only.

  • Page 88: Barcode Setup

    8.7. Patient Memory Card 8.7.1. Introduction This menu is available only if the ADVIA 60- is equipped with a smart card reader. The MEMORY program contains the seven following functions: 1 - MEMO : allows the operator to enable/disable the memory function.

  • Page 89: Memo Operation Mode

    8. INSTRUMENT CONFIGURATION 8.7.2. Memo operation mode 8.7.2.1. Memo on/off Insert the Patient Memory Card into the slot in the upper left corner of the analyzer. From the MEMOCARD menu, move the cursor to function MEMO and press ENTER. The following menu is displayed: MEMO >...

  • Page 90: Running The Samples

    8. INSTRUMENT CONFIGURATION 8.7.3. Running the samples Place the sample tube in the sample holder and close the door to start the analysis cycle. The following menu is displayed: PAT ID ? : NO SAVE : ESC CURRENT SAVE : ENTER Enter the patient identification and press ENTER.

  • Page 91: Print List

    8. INSTRUMENT CONFIGURATION 8.7.4. Print list The PRINT LIST option allows the operator to print out all the patient identifications recorded on the Patient Memory Card, the time and the date of the analysis as well as the backup number (column MEMO).

  • Page 92: Trans. All

    8. INSTRUMENT CONFIGURATION 8.7.6. Trans. all This function allows the operator to reprint or to send to the host all the results stored on the smart card. Check the quantity of paper before running a REPRINT ALL. From the MEMOCARD (Patient Card) menu, move the cursor to TRANS.

  • Page 93: Chapter 9. Maintenance And Troubleshooting

    Appendix B for recommended precautions when working with biohazardous materials. 9.1.2. Daily maintenance These cleaning procedures are required daily to maintain optimum performance of your ADVIA 60- CAUTION: Failure to perform any of these recommended cleaning procedures may result in decreased reliability of your system.

  • Page 94: Service Functions

    9. MAINTENANCE AND TROUBLESHOOTING 9.1.3. Service functions Several service functions are available for the user to clean and check his instrument. These functions are accessible from the Main menu. Move the cursor to the Function SERVICE and and press ENTER. The SERVICE menu is displayed: SERVICE >...

  • Page 95: Concentrated Cleaning

    9. MAINTENANCE AND TROUBLESHOOTING 9.1.3.4. Concentrated cleaning This procedure provides a strong cleaning of the RBC and WBC apertures. This cycle lasts approximately 3 minutes and involves the operator intervention to fill the chambers with sysCLEAR or diluted bleach solution. The diluted bleach solution is obtained by a 1:5 dilution of a commercial bleach solu- NOTE: tion containing from 10 to 15% of sodium hypochlorite.

  • Page 96: Mechanical Checks

    F - Valves : Move the cursor to the function VALVES and press ENTER. Closely observe the valve operations, the movement has to be straight and regular. NOTE: On the ADVIA 60- , the valve #3 is not installed. Page 9/4 075D0002-01...
  • Page 97 9. MAINTENANCE AND TROUBLESHOOTING G - Change contrast : The display contrast can be adjusted for a better readability. Move the cursor to the function CHG CONTRAST and press ENTER. The CHG CONTRAST menu is displayed: CONTRAST PRESS ENTER TO VALID HH:MM Press the UP key of the numeric keyboard to increase the contrast, or press the DOWN key to reduce the contrast.

  • Page 98: Cycle Functions

    The principal wastes associated with the use of the ADVIA 60- Hematology System are the TIMEPAC reagent containers, and the sysCLEAR reagent.

  • Page 99: Troubleshooting

    9. MAINTENANCE AND TROUBLESHOOTING 9.2. TROUBLESHOOTING 9.2.1. Overview Your ADVIA 60- may occasionally require troubleshooting if : - System operations are faulty. - The background count is unacceptably high. - Your control values are out-of-ranges, or patient results are suspicious (e.g., consistently high RBC counts or inability to verify results by manual methods).

  • Page 100: Calibration

    9.2.2.4. Calibration If the system appears to be operating properly, fresh uncontaminated reagents are being used, and the precision is within the specifications, the ADVIA 60- may need calibration. Calibrate your instrument as described in section 7. 9.2.3. Troubleshooting parameters The procedures described below should be performed whenever the precision of a parameter is not within the specifications noted above, or a parameter result is incorrect or suspicious.
  • Page 101 9. MAINTENANCE AND TROUBLESHOOTING If it is, continue. If sample probe is not in its correct position in the mixing chamber, call your local technical support provider or distributor. Diag. 9.1 Diluent dispenser : Do you see bubbles in the diluent dispenser? Is the plunger of the diluent dispenser moving up and down smoothly during sample analysis?

  • Page 102: Wbc

    9. MAINTENANCE AND TROUBLESHOOTING 9.2.3.2. WBC Check the following if only the WBC count is incorrect or suspicious. Concentrated cleaning procedure : Was the concentrated cleaning procedure performed earlier as part of the identification procedure? If not, perform the concentrated cleaning procedure. Calibration : Was the system calibrated earlier as part of the identification procedure.

  • Page 103: Rbc, Hct And Plt

    9. MAINTENANCE AND TROUBLESHOOTING HGB LED : Is the HGB LED illuminated when the system power is on? If it is and therefore all system operations are acceptable, call your local technical support provider or distributor. If the HGB LED is not illuminated when the system power is on, call your local technical support provider or distributor.

  • Page 104: Rbc

    9. MAINTENANCE AND TROUBLESHOOTING RBC chamber : Is the sample probe between the edge of the chamber and the center of the chamber, close to the bottom? If the sample probe is in its proper position in the RBC chamber (between the edge of the chamber and the center of the chamber, close to the bottom), and therefore system operations appear to be acceptable, call your local technical support provider or distributor.

  • Page 105: Hct

    The procedures described on the next pages should be performed whenever system operations are faulty. Identify the source of the malfunction and initiate the appropriate troubleshooting procedure. A "SERVICE" menu is available in the ADVIA 60- program to help the user in the troubleshooting of the hydraulic transfers and mechanical operations.

  • Page 106: Motors

    9. MAINTENANCE AND TROUBLESHOOTING Diag. 9.6 9.2.4.3. Motors After having switched on the instrument or whenever a problem occurs, the display may show some error messages concerning a failure in one of the motor initialization. These messages appear for a few seconds on the display and are as follow : - "ERROR : NEEDLE MOTOR"...

  • Page 107: Error Messages

    9. MAINTENANCE AND TROUBLESHOOTING 9.3. ERROR MESSAGES Some error messages can be displayed and require the operator intervention. Follow the instruc- tions given for each message and refer to the specified section. If the problem cannot be solved, call your local technical support provider or distributor. A - "ERROR : PRESSURE SYRINGE MOTOR": This message can be displayed at the instru- ment startup.
  • Page 108 9. MAINTENANCE AND TROUBLESHOOTING K - "ERROR : BAD DATE ! TRY AGAIN" : This message is displayed in the date change function when the new date entered is incompatible with the date format previously entered. Re-enter a correct date or change the date format. L - "ERROR : BAD TIME ! TRY AGAIN"...
  • Page 109 9. MAINTENANCE AND TROUBLESHOOTING Q - "HGB REFERENCE FAILED": this message is displayed when the instrument gives out of range HGB blank values after 3 consecutive HGB reference blank cycles. Check the expiration dates, replace the reagents if necessary or perform a concentrated cleaning. R - "4 HOURS ELAPSED BETWEEN LAST OPERATION": this message is displayed when the instrument has not been used for at least 4 hours.

  • Page 110: Purpose Of The Valves

    9. MAINTENANCE AND TROUBLESHOOTING 9.4. PURPOSE OF THE VALVES Valve #1 : Controls the lyse distribution Valve #2 : Cancels the pressure/vacuum in the pressure/vacuum syringe Valve #4 : Controls the cleaner input in the WBC counting head during the rinsing Valve #5 : Controls the drain of the pressure/vacuum syringe Valve #6 : Activates the vacuum needed in the WBC &...

  • Page 111: Menu Overview

    9. MAINTENANCE AND TROUBLESHOOTING 9.5. MENU OVERVIEW ADVIA 60-CT Parameters 2 SELECT LEVEL 1 - Low Select OP Parameters 1 2 - Normal 1 - Automatic 1 - RESULTS 3 - High Pat .ID / Run # 2 - Analysis...
  • Page 114 9. MAINTENANCE AND TROUBLESHOOTING Page 9/22 075D0002-01...

  • Page 115: Chapter 10. Service And Supplies

    Bleach Solution B01-4198-01 02488831 Bayer TESTpoint Hematology Controls B03-4200-54 04575197 Normal B03-4201-54 00133238 High B03-4202-54 00056756 ADVIA 60 SETpoint Calibrator B03-4203-51 09345602 Calibrator Memory Card 075-1100-02 08366266 Control Memory Card 075-1000-02 08564998 Patient Memory Card 075-1200-02 05963395 Bar Code Reader...

  • Page 116: For Service

    10.2.1 Bayer Authorized Representative Bayer Diagnostics Europe Limited Chapel Lane, Swords, Co. Dublin, Ireland 10.2.2 Bayer Offices Worldwide Manufactured by: Bayer S.A. Bayer HealthCare LLC Produtos Diagnósticos Subsidiary of Bayer Corporation Rua Domingos Jorge 1100 Diagnostics Division 04779-900 - São Paulo - SP...
  • Page 117 Centro de Atención Telefónica (CAT) Athens 151 25, Greece +55 57 28 33 12 +30 (0) 1-6883648 +55 57 28 33 06 Bayer HealthCare Co. Ltd. Bayer B.V. 20/F Gee Chang Hong Centre Health Care 65 Wong Chuk Hang Road...
  • Page 118 10. SERVICE AND SUPPLIES Bayer (South East Asia) Pte Ltd. No. 9 Benoi Sector Singapore 629844 +65-261-3389 Bayer (Pty) Ltd. Healthcare Division 27 Wrench Road Isando 1600, South Africa +27 (0) 11-921-5048 Química Farmacéutica Bayer, S.A. División Diagnósticos Calabria, 268 08029 Barcelona, España +34-93-4956500 Bayer (Schweiz) AG...

  • Page 119: Appendix A. System And Reagent Rolls

    APPENDIX A. SYSTEM AND REAGENT ROLLS A.1 System and Reagent Symbols The following symbols appear on the Advia 60 Hematology System, and the Advia 60 TIMEPAC reagent package. Warning. Biohazard Warning. Biological Risk WARNING: Indicates the risk of personal injury or loss of life if operating procedures and practices are not strictly observed.

  • Page 120: System And Reagent Symbols

    APPENDIX A. SYSTEM AND REAGENT SYMBOLS Up Navigation Down Navigation ON/OFF Ground Fuse Serial Port Printer Port The input electricity is alternating current. Caution. Risk of static discharge. Consult the instructions for use. The analyzer meets the safety requirements of Underwriters Laboratories. The analyzer meets the safety requirements of the Canadians Standards Association.
  • Page 121 APPENDIX A. SYSTEM AND REAGENT SYMBOLS Serial Number Catalog Number In Vitro Diagnostic Device Manufactured Location Authorized Representative Date of Manufacture CE Mark. Product meets the requirements of applicable European Directives. Temperature limitation (store between x°C – y°C) Batch code Use by Store upright Recycle...
  • Page 122 APPENDIX A. SYSTEM AND REAGENT SYMBOLS Page A/4 075D0002-01...

  • Page 123: Appendix B. Biohazard Protection

    APPENDIX B. BIOHAZARD PROTECTION B.1 Protecting Yourself from Biohazards BIOHAZARD All products or objects that come in contact with human or animal body fluids should be handled, before and after cleaning, as if capable of transmitting infectious diseases. Wear facial protection, gloves, and protective clothing.

  • Page 124: References

    APPENDIX B. BIOHAZARD PROTECTION • Keep your hands away from your face. • Cover superficial cuts and wounds. • Dispose of contaminated materials according to your laboratory’s biohazard control procedures. • Disinfect your work area with a 15% bleach solution. •...

  • Page 125: Appendix C. Bibliography

    APPENDIX C. BIBLIOGRAPHY C.1 Bibliography The following information was used to create the reagent information in this manual. Bessman, JD; (1986) Automated Blood Counts and Differentials, Johns Hopkins University Press Groner W, Simson E; (1995) Practical Guide to Modern Hematology Analyzers: Wiley 1-241 Corash L;...

  • Page 126: Bibliography

    APPENDIX C. BIBLIOGRAPHY Page C/2 075D0002-01...
  • Page 127 INDEX Index Autocleaning Frequency 8-9 Printer Select 8-3 Calibration 6-3, 7-2, 7-6 Change Date and Time 8-11 Change Laboratory Limits 8-4 Quality Control 6-3 Change Operator 8-7 Messages 7-13 Checks Visual 2-3 Concentrated Cleaning 9-3 Reagent Pack Connnections 2-5 Installation 2-5 Date Priming 2-7 Change 8-11...

  • Page 128: Index

    INDEX Index/2 075D0002-01...

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