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Horiba ABX Micros 60 - User manual

1. 1 5 1 4 Statistics and Quality Control eee eese esee eene ener nena 1 5 1 5 COO OE E M 1 5 1 6 eru 1 5 1 7 Measurements and Computation 1 5 1 8 OUTPUTS e 1 5 ABE 1 6 1 10 Barcode Reader Options 1 6 2 Physical Specifications 222 eco eoe 1 6 2 1 Power Requirements 1 6 2 2 Operating Temperature Humidity 1 6 2 3 Dimensions and Weight eee eese enne eene nnne enne 1 6 CLR ree A 1 6 2 5 Minimum Sample 1 6 2 6 Dilution 1 7 2 7 Counting Aperture 1 7 2 8 Hemoglobin Measurement 1 7 3 Summary of Performance Data eene eene nente neon eset neenon 1 8 3 1 Precision Reproducibility sees eee eene eene e
2. 2 8 253 12 MEM E 2 8 LCPNDUMM 2 9 8 3 9 WBC E 2 9 ABX Micros User Manual RABO42IEN 1 ABX Micros GO 1 Description 1 1 Overview 1 LCD screen display 2 Key pad control panel 3 Smart card reader optional 4 Reagent compartment 5 Sample probe and analysis Start bar 1 2 Front view covers opened 1 Carriage Assembly 2 Sample probe and Analysis Start bar f T 3 WBC HGB Chamber 4 RBC Chamber 2 RABO42IEN User Manual ABX Micros GO Description amp Technology Technology 1 3 Left side view covers opened 1 Diluent Temperature Sensor 2 Liquid Syringe 3 Valve Block 4 Vacuum Waste Chamber 2 Technology 2 1 Sampling 1 Blood Collection tube cap is removed 2 The Tube is placed beneath the sample probe 3 The Tube is move upwards and the sample probe enters into the blood 4 The Manual sample bar is pressed and aspiration of 10pl of Blood occurs 5 Needle Carriage assembly moves to the Left over the WBC HGB Chamber 6 The External Sample probe rinses 7 Blood sample is delivered into the WBC Chamber for the First dilution 8 Aspiration of 28 of diluted blood from the WBC Chamber 9 Needle Carriage assembly moves to the Right over the RBC PLT Chamber 10 The External Sample probe rinses 11 Diluted Blood sample is delivered into the RBC Chamber for the
3. eee eere 1 16 4 3 7 MCHC Mean Corpuscular Hemoglobin Concentration 1 16 4 3 8 RDW Red cell Distribution Width 1 16 4 329 PET Platelets er pa eur eo Pau geo 1 17 4 3 10 MPV Mean Platelet Volume 1 17 4 3 11 LYM 4 Lymphocyte count Absolute Number 1 18 4 3 12 LYM Lymphocyte Percentage 1 18 4 3 13 MON Monocyte count Absolute Number 1 18 ABX Micros User Manual RABO42IEN 1 ABX Micros GO 4 3 14 MON Monocyte 1 18 4 3 15 GRA Granulocyte count Absolute Number 1 18 4 3 16 GRA 95 Granulocyte Percentage eere 1 18 5 Reagent Specifications a ee Saa na Pe Eoo SU 1 19 6 Reagent Consumption eee eee eee e eee een eene enne sees 1 20 7 Waste Handling Procedure ccce ee ecce eee eee eee eee eee eene e nete nno eere eo ette en 1 20 2 RABO42IEN User Manual ABX Micros GO Specifications Technical Specifications V1 7 0 1 Technical Specifications V1 7 0 WBC RBC and PLT Histograms Quantitative Flags Parameter selection by choice of So
4. 5 17 8 ipis Me 5 17 8 1 7 5 17 8 2 Running Patient Samples 5 18 8 3 Transmission Of Resulls DO aee E ERN Ode RE PETENS 5 18 5 19 8 5 5 19 8 6 Reprint Results TR ALL 5 20 8 7 Reprint From To TR FROM TO 5 20 8 8 Clear Card Erasing All Results from the Card 5 21 ABX Micros User Manual RABO42IEN 1 ABX Micros GO 1 Setup overview The ABX Micros GO has several operator options in this section Specific Laboratory limits see 3 Laboratory Limits page 7 Date and time formats see 5 Date and Time page 14 Results format see 2 Results Options page 3 RS 232 options see 6 Host Computer Options page 15 Special functions see 4 Special Functions page 10 These options can be configured according to the operator s needs through the SETUP Menu functions Accessing Setup Menu Main menu 5 Setup Menu overview Tab 5 1 Menu Setup overview SETUP 2 Chg lab limits 1 Low limits 2 High limits 3 Print limits 1 SCL 2 SCH 3 MIC 4 Flag limits 4 L1 2 RABO42IEN User Manual ABX Micros GO Setup Results Options Tab 5 1 Menu Meetup overview 4 Date
5. 1 6 Summary of Performance Data eerte eei ee eaae oe Se eee a ER sg eee riie 1 8 inca N 1 13 Reagent Specifications 52 eor ceto topo eure eor o ase REP SESS TERRE eK RR 1 19 Reagent CONSUMPTION 1 20 Waste Handling Proced r iiie eoe cierre ta oes eoe voee tero Eee o eoa Pe RN YER raro 1 20 Section 3 pel iiio Rc P 3 1 Startup checks eere eet teer eee eene oe ee Yves oe Nast ec pase pare cree uae a ERU u 3 2 Daily Quality Control amp Calibration verification 3 5 Sample selection and identification 3 6 RUNNING SAMPleS A 3 8 RESULTS 3 10 EEE 3 15 Section 2 Description amp technology essesssessssssessessesssesseesesssessees 2 1 Description Technology Section 4 Quality Assurance tenia du DEO RP E duravit Ea DR HR ur 4 1 Quality Mo Tu H 4 2 icu 4 11 Section 5 Setup sesiis 5 1 KIIEO uc 5 2 HzdcEsnqnpgpee 5 3 Laboratory eem 5 7 Special FUNCOMS A 5 10
6. 4 19 ABX Micros User Manual RABO42IEN 1 ABX Micros 6 1 Quality Control 1 1 Functions It is highly recommended that you use the ABX MINOTROL Quality Control blood product when running Q C on the ABX Micros GO analyzer This product is specifically designed for use with the ABX Micros GO analyzers Call your local HORIBA Medical Customer Service Representative for information and ordering of this specialized product The ABX Micros GO 05 0 Quality Control program contains 5 different functions in its menu Quality Control overview 1 Automatic to analyze commercial control bloods and store results on the Quality Control smart card see 1 2 Q C Automatic With Q C Smart Card page 2 2 Analysis to analyze commercial control blood with fixed WBC Thresholds specifically for use Without a Smart Card see 1 3 Q C Analysis Without Q C Smart Card page 7 3 Print Targets to print QC product target values fromthe QC Smart Card Only see 1 4 Q C print targets only with Q C smart card page 8 4 Statistics to print the cumulative statistics for commercial control bloods from the QC Smart Card Only see 1 5 Q C statistics only with Q C smart card page 8 5 Graphs to print the Levey Jennings graphs of the commercial Control blood products from the QC Smart Card Only see 1 6 Q C Graphs Only with Q C smart card page 9 When running
7. eene eene enne 3 15 6 2 2 Results Rejected 3 16 6 2 3 Results Comparable 3 16 6 2 4 HGB Blank Reference 3 16 6 3 Morphology Flags iatan aaea eese a Eai 3 17 6 3 1 Flags PLT Distribution curve eene eene tenens 3 17 6 3 2 Flags on WBC Distribution curve 3 17 ABX Micros User Manual RABO42IEN 1 ABX Micros GO 1 Startup checks needs to be emptied During the operation do not remove the reagent tubes and the waste liquid tube under any condition At the beginning of each day before running a Startup check if the waste container 1 1 Reagent level checks Make sure a Startup and a Control Blood have been performed after a reagent replacement 1 1 1 Bottled units Individual reagents first thing prior to Startup is checking the levels of each reagent before operating the system If a reagent level is Low replace the reagent and prime the new reagent using the following steps through the instrument menus Never pour reagent from one container into another Any type of contamination present A in the old reagent will affect the new reagent Unacceptable background counts will most likely occur especially for PLT s Always use the reagents caps provided with the instrument to pr
8. eene nennen enne nnne enne nennen een 6 13 1 6 Automatic Cleaning ne E ERR AE PURO SERERE 6 13 1 7 Manual Probe Cleaning ec eeeeee eese eene eene n nene tenen nenne 6 13 1 7 1 Unblocking the Sample Probe eeeeeeeeeee eene eene nenne 6 14 1 7 2 Replacing the Sample Probe 6 15 1 8 Extended Concentrated Cleaning cseeeeee esee eee eene eene enne nennen 6 15 2 Troubleshooting 6 17 BV OVEPVICW ses 6 17 2 2 Problem Identification nen nnne 6 17 2 2 1 System Operations P M 6 17 2 72 Dc 6 17 272 3 PIECISION occas oe esee x ec dip eoa eene 6 18 2 24 Calibration 6 18 2 3 Troubleshooting Parameters eene eene nennen 6 18 2 3 1 Problems on all Parameters csse 6 19 2 3 2 Problems on RBC PLT parameters only 6 20 2 3 3 Problems on WBC HGB parameters only 6 21 2 4 Troubleshooting System Operations eene eene nnne 6 22 2 5 Troubleshooting Specific ERROR Messages
9. MON 9 MON GRA 2 4 Printer Selection This sub menu allows the selection of the printer to be used along with the ABX 60 4 basic different model types of printers specifically designed to operate with the ABX Micros GO analyzer Selecting printer Main menu 5 Setup 1 Results 4 Printer Use Up or Down arrow key to choose one of the 5 printer as follows 1 Reserved 1 for Epson LX series printers 2 Reserved 2 for Star printers 3 Reserved 3 for Seiko Thermal printers 4 Standard for Citizen Dot Matrix printers 5 None for Use with External Computers Press the Enter key to confirm use as an Extended Q C Package or and L I S connection This selection is also used if The 5 None printer selection is used for an External Computer that is specifically 4 aprinter is not going to be used in conjunction with the ABX Micros GO analyzer Once the Printer type has been selected verify that a result will print from your selection proceed as described in 2 1 Reprint Results page 3 Now verify that the last result ran will transmit to the printer and printout from the printer selection previously made 2 5 Temperature Printout This sub menu allows the operator to have visual confirmation of the diluent temperature displayed on the results printout between the specified limits 18 C 32 C or 65 F to 85
10. Fig 4 4 Passed Calibration printout included in the statistical calculations This first sample is considered as a Calibrator The to the right of RUN 1 indicates that the first calibration sample is not 4 material prime The instrument wait for the operator to press any key to return to the MAIN MENU ABX Micros User Manual RABOA42IEN 15 ABX Micros GO 2 2 9 Calibration Failed the screen display Rejected and saved coefficients can be displayed by using the Up and Down arrow keys on the front panel Press the Esc key to return to Main Menu In order for ABX Micros GO to Fail Calibration the data must meet the statistical criteria which contain 2 conditions 1 The Coefficient of Variations are out of thier specified limits as indicated in Tab 4 2 Coefficient of variation limits page 15 2 The difference between the Target value and the Mean for each parameter that failed calibration is greater than 2090 When ABX Micros GO Fails calibration the results will be printed out the Calibration coefficients are Rejected and the previous coefficients will remain unchanged in memory and the screen will indicate CALIBRATION FAILED When the Calibration STATUS indicates FAILED on one or more parameters even though stating OK on the other parameters Calibration will not take place When the calibration fails the operator may restart the ca
11. 6 23 3 LCRITASO TSIAUETPE 6 24 ABX Micros User Manual RABO42IEN 1 ABX Micros GO 1 Maintenance One of the principle factors contributing to accurate and reliable results is a well maintained instru ment The ABX GO is designed to keep this maintenance automatically to a minimum providing that the operator is aware of its schedule This section of the manual will describe the daily and periodic maintenance procedures 1 1 Daily Maintenance These cleaning procedures are required daily to maintain optimum performance of your ABX Mi cros 6O creased reliability of your system It is important that you monitor your analyzer for the T Failure to perform any of these recommended cleaning procedures can result in de types of specimens that may cause pre mature cleaning other than routine 1 1 1 Startup and Standby Cycles At the beginning of each business day a Startup cycle must be performed This can be done either automatically or or manually which ever the system has been set up for See Section 5 4 3 Choosing Startup Cycle page 5 11 Running manually a Startup cycle Press the Startup key of the front panel At the end of each business day a Standby cycle should be performed Once the Standby cycle is complete you may power off the instrument or leave it in the standby mode overnight Running manually a Standby cycle Press the Standby key of the front panel of Protein bui
12. General recommendations calibration The calibration on HORIBA Medical instruments is an exceptional procedure which must be carried out particularly in case of certain technical interventions installation maintenance service intervention The calibration should not be carried out to compensate a drift on a result due for example to a clogging of the instrument Running control blood Mix the sample gently and thoroughly Remove the cap from the sample tube Place the sample beneath the sample probe Raise up the tube so that the sample probe lowers into the blood and press the manual sam ple bar or press the Startup key The analysis cycle will begin If any results are out of their acceptable ranges perform the following steps 1 Rerun the Control blood 2 Clean the system see Section 6 1 3 6 Concentrated Cleaning page 6 11 Re run the sample 3 Open a new vial of control material 4 Call your local HORIBA Medical Technical support representative before re Calibrating the system ABX Micros User Manual RABO42IEN 5 ABX Micros GO 3 Sample selection and identification 3 1 Sample identification modes 3 1 1 US Mode configuration see Section 5 4 7 Choosing sample identification mode page 5 14 for v The Sample Identification modes are selected from the Setup menu in the system selecting the Mode for your daily operations This mode requires a patient identification on e
13. Fig 6 8 Door page 9 to open the pneu matic protection door 8 RABO42IEN User Manual ABX Micros GO Maintenance amp Troubleshooting Maintenance Fig 6 8 Door Unscrew the 3 cover fixation screws A and loosen the 2 screws B under the reagent flap Fig 6 9 Cover page 9 Remove the cover pull it backward and lift it up to the rear of the instrument Fig 6 9 Cover 1 3 3 Backflush This service function will allow the operator to clean the counting chamber apertures in case of blockage Performing a backflush cycle Main menu 4 Service 1 Backflush Press the Enter key Open the instrument door and verify that liquid is being pulled through the apertures watch for few micro bubbles in the count tubing coming from the count head When the backflushing starts verify that liquid is being pushed back through the apertures watch for few micro bubbles coming into the chambers through the count head ABX Micros User Manual RABO42IEN 9 ABX Micros GO If you cannot see any micro bubbles moving through tubing or in the chambers the aperture may still be blocked In this case perform a Concentrated Cleaning Section 6 1 3 6 Concentrated Clean ing page 6 11 1 3 4 Drain Chambers This service function will allow the operator to check for proper chamber draining and to maintain some of the parts of the hydraulic manifold as it flushes waste out of the instrument Drain
14. Very Small Erythrocytes Microcytes Erythrocyte s fragments Schistocytes and WBC fragments may interfere with the proper counting of Platelets and cause elevated Platelet counts Agglutinated Red Blood cells May trap platelets causing an erroneously Low platelet count The presence of agglutinated RBC s may be detected by observing abnormal MCH and MCHC values and by careful exmination of a stained blood smear Giant Platelets in Excessive Numbers May cause an erroneously low platelet count since these Large platelets may exceed the Upper Threshold limit for platelets and are not counted as platelets Chemotherapy Cytotoxic and Immunosuppressive drugs may increase the fragility of these cells which may cause Low platelet counts Reference Manual methods may be necessary to obtain an accurate platelet count Hemolysis Hemolyzed specimens contain Red blood cell Stroma which may cause elevated platelet counts A C D Blood Blood anti coagulated with Acid Citrate Dextrose may contain Platelet Aggregates which could give falsely low platelet counts RBC Inclusions Erythrocyte inclusions such as Howell Jolly bodies Heinz bodies Siderotic and Basophilic granules etc may produce considerably elevated platelet counts Platelet Agglutination Clumped Platelets due to poor collection techniques or platelet satellitosis caused by EDTA activation of Immunoglobulins may cause a Low platelet count and or an elevated WBC
15. key Enter new value Use the key for placing the decimal point in the correct order Press the Enter key Select the next parameter to edit using Up or Down arrow key Repeat the same steps to modify values Press the Esc to return to the Chg Lab Limits Menu ABX Micros User Manual RABO42IEN 7 ABX Micros GO 3 3 Print Limits This Chg Lab Limits sub menu allows the operator to print out the current Laboratory Limits and Morphology Flag values Changing Laboratory limits Main menu 5 Setup 2 Chg Lab Limits 3 Prt Limits Press the Enter Key The current Laboratory Limits will automatically print out as shown in Fig 5 1 Laboratory limits printout page 8 LIMITS DATE 01 20 2002 TIME 10 54 LOW HIGH WBC 3 5 10 0 103 mm RBC 3 80 5 80 106 mm HGB 11 0 16 5 9 4 HCT 35 0 50 0 MCV 80 97 um MCH 26 5 33 5 pg MCHC 31 5 35 0 9 4 PLT 150 390 103 mm MPV 6 5 11 0 um RDW 10 0 15 0 LYM 17 0 48 0 9MON 4 0 10 0 43 0 76 0 LYM 1 2 3 2 103 MON 0 3 0 8 103 GRA 1 2 6 8 103 mm Flags SCL 8 0 SCH 8 0 MIC 8 0 WBC Flags 11 8 0 2 8 0 61 15 0 63 8 0 Fig 5 1 Laboratory limits printout Verify your entries Check each parameter to make sure that you have entered the correct number and placement of the decimal point PCT and PDW are not available in the United States These par
16. Beal Time DIES CAU CDU when entering the time Startup cycle not initiated Press the Startup key to run a Startup Enter correct value between 0 to 99 999 for sample Run Out of range Target value in Autocalibration Enter the correct target value Bad Value MINI XXX MAXI XXX error Out of range run number in Autocalibration Enter the correct run number between 3 to 11 Cal coefficient out of range Enter the coefficient within the range specified in Calibration amp Quality Control section Correct your value to be within the specified ranges given If unable to be within the w Minimum and Maximum values are displayed with the corresponding error message range specified call your local HORIBA Medical Technical Support Representative 3 Menu Overview Tab 6 7 Menu RESULTS 1 RESULTS Parameters 1 Pat ID Run Flags Parameters 2 Tab 6 8 Menu QC 1 Automatic QC Smart card menu Select OP lot Select level 1 Low 2 Normal 3 High 2 Analysis 3 Print targets QC Smart card menu Select OP lot Select level 1 Low 2 Normal 3 High 24 RABO42IEN User Manual ABX Micros GO Maintenance amp Troubleshooting Menu Overview Tab 6 8 Menu QC 4 Statistics QC Smart card menu Select OP lot Select level 1 Low 2 Normal 3 High Tab 6 9 Menu CALIBRATION 2 Coefficients 1 Calibration coefficients Password WBC RBC HGB H
17. Date and 5 15 Host COmputer yo de dE Rana dod 5 16 Barcode Setup Memory Card Section 6 Maintenance amp Troubleshooting 6 1 M P 6 2 Urs 6 18 o ee eger eese 6 25 ABX Micros User Manual 421 17 ABX Micros 60 10 User manual modifications 10 1 Corrections associated to V1 7 0 Software version 1 7 0 Version Updates Introduction 2 declaration of conformity Introduction 3 Weee directive Introduction 8 Identification Label Introduction 11 PRP Specification removed eee rete ades Introduction 11 Installation procedure removed technical manual Introduction 13 Package content eee xe ee evo Introduction 13 360 Chap 1 5 link GD Reagent leaflets eret tree cous eet roe terree Chap 1 5 Heat Output DoD e
18. PCT and PDW have not been established as indications for this product in the United States The use of PCT and PDW should be restricted to Research Use Only highly recommended that each laboratory establish its own Normal ranges based upon v Expected values will vary with sample population and or geographical location It is the local population ABX Micros User Manual RABO42IEN 11 ABX Micros GO 3 7 Accuracy The Accuracy performance was proven by analyzing approximately 200 patient specimens on the ABX Micros GO along with a commercially available Reference Analyzer located in 3 different locations throughout the United States The following table summarizes the data Tab 1 12 105 mm 198 0 992 0 997 0 995 RBC 105 mm 198 0 995 212 0 995 204 0 990 HGB g dl 188 0 994 212 0 998 204 0 985 HCT 90 198 0 980 212 0 994 204 0 982 MCV um 198 0 988 212 0 987 204 0 980 MCH pg 188 0 969 212 0 962 204 0 962 MCHC g dl 188 0 311 212 0 654 204 0 471 RDW 90 198 0 950 212 0 944 204 0 895 PLT 105 mm 169 0 994 201 0 981 198 0 926 MPV um 191 0 639 204 0 709 203 0 863 Lymphocytes 90 98 0 975 110 0 991 119 0 461 Monocytes 98 0 552 104 0 787 119 0 461 Granulocytes 90 98 0 969 105 0 990 119 0 968 Reference Analyzers Baker System 9000 Coulter S Plus IV Coulter JT n Number of specimens analyzed R Correlation coefficient from the regression curve Reference ABX Micros GO As m
19. Technology Technology Number of cells Cell size Fig 2 4 RBC Pulses electronically calculated and smoothed RBC Distribution curve Number of cells Cell size Fig 2 5 PLT pulses electronically calculated and smoothed PLT distribution curve RBC Histogram is an electronic Distribution and mathematical calculation of the RBC s placed into 256 Channels of volumetric sizing from 30fl to 300fl PLT Histogram is an electronic distribution and mathematical calculation of the PLT s placed into 128 channels of volumetric sizing from 2fl to a mobile threshold between the high end platelets to the Low end Red Blood Cell Thresholds fl femtoliters A microscopic volumetric unit of measurement This is 3 dimentional measurement used to determine the volume of Microscopic particles 2 3 2 HGB The Hemoglobin measurement is based on a Startup cycle This cycle includes a Hemoglobin Blank test sequence which includes 2 Hemoglobin blank measurements Each analysis cycle run after Start up also has a Hgb Blank measurement which is compared to the initial Start up Hgb Blank Each analysis cycle run thereafter compares the Hgb Blank reading to the previous cycle Hgb Blank reading During the WBC analysis cycle 0 5ml of Lyse Reagent is added to 2 05ml of diluted blood in the WBC Chamber The Lyse reagent contains potassium ferricyanide Fe Cn K and potassium cyanide KCN This lysing reagent breaks down the RBC Cell membra
20. decreasing linearly to 50 relative humidity at 40 C 104 Avoid exposure to direct sunlight Avoid exposure to air conditioning and or heating ducts 2 3 Dimensions and Weight S Height iieri nennt Approximately 440mm 16 5 inches e Width tr Approximately 360mm 14 2 inches Approximately 330mm 12 6 inches Weight rne Approximately 14Kgs 31 lbs 2 4 Wastes Automatic disposal Waste handling according to Local National regulations 2 5 Minimum Sample Volume Minimum blood sample requirement 50ul 6 RABO42IEN User Manual ABX Micros GO Specifications Physical Specifications 2 6 Dilution Ratios ME M Approximately 1 250 S RBC PLT 2 ette eroe nnn Approximately 1 15000 2 7 Counting Aperture Diameter dle 80 Lola 50um 2 8 Hemoglobin Measurement Performed in the WBC HGB Chamber Light source LED Light Emiting Diode at wavelength 550nm ABX Micros GO User Manual RABO42IEN 7 ABX Micros GO 3 Summary of Performance Data 3 1 Precision Reproducibility The ABX Micros GO was initially calibrated with Minocal Calibrator Lot N MCAL 325 Expiry Date 11 05 2002 Three levels of ABX Minotrol 16 control material Lot N M243 were run in duplicate twice daily for 20 days The results were used to quantify within run precision SD of the run means SD o
21. 00 MIC 8 00 Editing Flag values Plt and WBC Main menu 5 Setup 2 Chg Lab Limits 4 Flag Limits Press the Enter Key Choose the flag to edit using Up or Down arrow key Press the Enter key Enter new value Use the key for placing the decimal point in the correct order Press the Enter key Select the next flag value to edit using Up or Down arrow key Repeat the same steps to modify values Press the Esc to return to the Chg Lab Limits Menu 3 4 2 WBC flags Factory Default adjustment values are as L1 8 00 M2 8 00 G1 15 00 G3 8 00 ABX Micros User Manual RABO42IEN 9 ABX Micros GO 4 Special Functions The Special sub menu will allow the operator to access and edit some of the following sub menu functions such as 4 1 Changing Operator page 10 4 2 Changing the User Password page 10 4 3 Choosing Startup Cycle page 11 4 4 Setting Autocleaning frequency page 11 4 5 Printing Instrument Configuration page 12 4 6 Setting buzzer cycle page 14 4 7 Choosing sample identification mode page 14 4 1 Changing Operator 4 Operator Identifications are available and can be modified Changing operator Main Menu 5 Setup 3 Special Press the Enter key Enter system default Password 123 or the one defined by the operator Press the Enter key Select 1 Chg Op
22. 1 Declaration of conformity Latest version of the CE declaration of conformity for this instrument is available on www horiba com 1 2 Notice of liability The information in this manual is distributed on an As Is basis without warranty While every precaution has been taken in the preparation of this manual HORIBA Medical will not assume any liability to any persons or entities with respect to loss or damage caused or alleged to be caused directly or indirectly by not following the instructions contained in this manual or by using the computer software and hardware products described herein in a manner inconsistent with our product labeling 1 3 Trademarks Product names mentioned within this publication may be trademarks or registered trademarks of their respective owners 1 4 Copyright 2009 HORIBA ABX SAS All rights reserved No part of this book may be reproduced or transmitted in any form or by any means electronic mechanical photocopying recording or otherwise without the prior written permission of HORIBA Medical 1 5 Potential hazards To alert the operator of potentially hazardous conditions one of the bold captioned headings which are described below is provided wherever necessary throughout this text WARNING Flags a procedure that if not followed properly can prove to be extremely hazardous to either the operator or the environment or both CAUTION Emphasizes an operating procedure that must be follo
23. 100 4 90 105 3 80 5 80 MCH 30 6 Pg 26 5 35 5 HGB 15 0 9 4 11 0 16 5 34 1 g dl 31 5 33 5 HCT 43 9 35 0 50 0 1805 11 0 16 0 PLT 287 103 mm 150 390 8 8 um 6 5 11 0 WBC Flags LYM 39 3 20 0 45 0 2 2 103 1 2 3 2 7 3 96 4 0 10 0 MON 0 4 103 mm 0 3 0 8 AGRA 53 49 43 0 76 0 HGRA 30103 mm 1 2 6 8 RBC PLT 30 100 230 TO 30 Printed information printed is as followed 1 The Date the sample was analyzed 2 The Time the sample was analyzed 3 The Sample Identification that was entered by the Operator Run if Standard mode 4 The Sequence number of the sample run 5 The Instrument STARTUP status none in Standard mode 6 The PLT flags if any were reported 7 The 16 Parameter CBC results with limit flags and units 8 The WBC flags if any were reported 9 The 3 part Differential LMG results 10 The WBC RBC and PLT Histograms increases by increments of 1 each analysis cycle sequentially this sequential number The sequence number is updated to the number 1 each calendar day the number 4 not be modified by the operator 14 RABO42IEN User Manual ABX Micros GO Workflow Flags 5 3 ABX Micros GO OS OT18 The ABX Micros GO 05 0118 has all the same characteristics as the ABX Micros GO OS 0T16 with the exception of 2 parameters PCT and PDW which are reported on the ABX Micros GO 05
24. 11 1 08 1 20 0 94 1 00 1 00 Maximum 1 29 1 05 1 39 1 29 1 41 1 13 1 25 1 25 If any of the calibration coefficients are out of their specified ranges after calibrating the ABX Micros 60 contact your local HORIBA Medical Technical Support Representative ABX Micros User Manual RABOA42IEN 19 ABX Micros GO 20 RABO42IEN User Manual ABX Micros GO Setup Contents mc dnpMulae 5 2 2 aD Tr 5 3 2 1 Reprint c 5 3 2 2 a 5 4 5 4 2 4 Printer Selection eH RR REF Ee 5 5 2 5 Temperature Printout nennen nennt nnne nenne nnns 5 5 AEn 5 6 2 7 PANE LMG 5 6 3 Laboratory Limits dseseseccccceessvestscalecvssdeassicnvetvecst ascceesssssecsevesteessceuecssvausssseeees 5 7 3 1 Results Low noc ss i a ve OE Se sve 5 7 3 2 Results High LIMES peu Dao ene Oc ee REY 5 7 3 3 Print LIMITS roov eese se eere veo sore ere edere no ee eodd UE DUE NER VESPERE eov ea E 5 8 3 4 Morphology Flag LIMILS E Orne OH d oae HER 5 9 3 41 Platel
25. 2g dL result result D DIL HGB g dL result result D DIL HCT result result D DIL ABX Micros User Manual RABOA42IEN 15 ABX Micros GO Tab 3 2 Printed and host transmitted results WBC x10 mm result result D D o 0 RBC x10 mm result result D D ap 0 PLT x105 mm HGB 2g dL result result D D 0 PLT x10 mm HGB lt 2g dL result result D D 0 HGB g dL result result D D eme de 0 result result D D o 0 Whole Blood parameter results within visible range will still give a result value with a D indication These results require a dilution or PRP analysis for PLT of the sample 6 2 2 Results Rejected A Reject flag shown by an asterisk following the Parameters WBC RBC HCT or PLT indicates that the ABX Micros GO has analyzed that parameter for a maximum of 3 counts All 3 counts were outside the system precision limits for that specific parameter The results should be verified by re running the sample 6 2 3 Results Comparable A reportable result shown by a Dollar sign following the parameters WBC RBC HCT or PLT indicates that the ABX Micros GO has analyzed that parameter for a maximum of 3 counts Two out of three counts were within the system precision limits for that specific param
26. 3 Standard mode Running analysis Press the ID key and enter the Run See 3 1 2 Standard Mode 6 Remove the cap from the sample tube Place the sample beneath the sample probe raise the sample tube upwards so that the sam ple probe enters into the blood Press the manual sample bar and analysis will begin Press the Startup key on the front panel if the system does not respond to the Manual sample bar If the instrument has not been in operation for 1 2 hour and an analysis cycle is initiated the ABX Micros GO will start a HGB Reference cycle The message Please wait will be displayed on the LCD screen Once the HGB reference cycle is complete the message Press the sampling bar will appear 4 4 Automatic Cleaning Cycle The ABX Micros GO will perform an automatic cleaning cycle once the analysis cycles have reached the programmed cycle limit set in the Setup Menu see Section 5 4 4 Setting Autocleaning frequency page 5 11 When an Automatic cleaning cycle begins a message will appear on the screen A Manual cleaning can be requested at any time by the operator Manual Autoclean Main Menu 4 Service 8 Auto Clean 8 RABO42IEN User Manual ABX Micros GO Workflow Running Samples 4 5 End of the day rinsing It is necessary to run a Standby Shutdown cycle at the end of each day Shutdown cycle Press the Standby key on the front panel The ABX Micros GO perfo
27. 3 2 Problems on RBC PLT parameters only Tab 6 3 Problem Noted Possible Cause Corrective Action Startup Failed No results in analysis Suspicious patient results QC outside acceptable limits Poor repeatability Possible dirty aperture Possible partial blockage in sample probe Possible leakage from syringe block Possible contaminated reagent s Possible dirty apertures Has Diluent been delivered correctly into RBC chamber Possible dirty Aperture Possible leakage from syringe blocks Possible dirty chamber Possible dirty aperture Possible leakage from syringe blocks Poor calibration Possible dirty apertures Possible leakage from syringe blocks Possible dirty chamber Incorrect sample mixing 20 RABO42IEN User Manual ABX Micros GO Perform a concentrated cleaning 1 3 6 Concentrated Cleaning page 11 re run sample Remove and flush out sample probe as described in Section 6 1 7 Manual Probe Cleaning page 6 13 Check syringe block for leakage and call HORIBA Medical Technical support Check and or replace reagent s if necessary Perform a concentrated cleaning 1 3 6 Concentrated Cleaning page 11 re run sample Check for diluent delivering into cham ber call HORIBA Medical Technical support Perform a Concentrated cleaning 1 3 6 Concentrated Cleaning page 11 re run sample Check syringe blocks for leakage and call HORIBA Medical Technical suppor
28. Automatic If the operator needs to Exit Q C at any time before all levels of control bloods are analyzed it is possible to do so by following these simple steps 1 Wait until the cycle of the control level blood being analyzed is complete Exiting QC automatic Press the Esc key Valid message is displayed Press the Esc key The display returns to Start QC message Press the Esc key Exit QC message is displayed Press the Enter key QC not valid message is displayed QC not stored on the Smart card The display returns to the QC menu 1 3 Q C Analysis Without Q C Smart Card 1 Remove the Quality Control blood from the refrigerator and bring it to room temperature Entering QC Main Menu 2 QC 2 Analysis This menu will allow the operator to run a control level blood as a normal analysis cycle Without the use of a Smart Card but with specific LMG Thresholds for control level bloods Independant from the Temperature Identification of the control blood Lotit message is displayed Enter a Lot number from 1 to 10 Alphanumeric characters Use the Number keys to enter the numbers directly Use the Up or Down arrow keys to select each Alpha character Press Enter key after each Alpha entry Press the Enter key to accept it A brief HGB Blank reference measurement is performed before the analysis cycle When the HGB Blank reference measurement is complete a mess
29. Control CAL Calibrator Ground This product should be disposed of and recycled at the end of the useful life in accordance with the WEEE Directive 2002 96 CE Packaging recycling mark Content Notice of environment friendly use period All graphics including screens and printout photographs are for illustrations purposes only and are not contractual 10 RABO42IEN User Manual ABX Micros GO Introduction Labels 5 Labels 5 1 Main power label In order to replace the 2x1A Fuses located under the power plug connection on the back of the analyzer carry out the following procedure Do not remove the instrument protection cover Power OFF the analyzer Disconnect the main power cable from the back power cord receptacle on the analyzer Pull the little flap marked 250V fuse Remove the fuses from their holding receptacle Use only fuses having the following characteristics 1A TT 250V 5 2 Input Output Label Waste Connect the waste output line to the Waste position fitting Note the Waste label for Waste output Only Diluent Connect the Diluent input line to the Diluent position fitting Note the Diluent label for Diluent input Only Lyse Connect the Clear tubing marked with a MINILYSE label to a straw and place it into the Lyse reagent container Miniclean Connect the Blue tubing marked with a MINICLEAN label to a straw and place it into the Miniclean reagent c
30. F Results obtained JJ The operating temperature of the Diluent during analysis must remain in temperatures outside these limits are questionable and may not be valid ABX Micros User Manual RABO42IEN 5 ABX Micros GO Printing diluent temperature Main menu 5 Setup 1 Results 5 Print temp y n Press the Enter key Use the Up or Down arrow keys to select 1 Yes Print with Temperature 2 No Print without Temperature Press the Enter key a indicates the current state 2 6 Print Limits This sub menu will enable disable the printing of the Laboratory Limits defined as described in 3 Laboratory Limits page 7 on the results printout Printing Laboratory limits Main menu 5 Setup 1 Results 6 Print Limits Use the Up or Down arrow keys to select 1 Yes Print with with Limits 2 No Print without Limits Press the Enter key a indicates the current state 2 7 Print LMG Results This sub menu will enable disable the printing of the 3 part Differential parameters on the results printout v This Menu function is available Only on ABX Micros GO 16 and 18 parameter systems Printing LMG results Main menu 5 Setup 1 Results 7 Print LMG results Use the Up or Down arrow keys to select 1 Yes Print with LMG results 2 No Print without LMG results Press the Enter key a indicates the current state 6 RABO42IEN User Manual AB
31. MINILYSE LMG 1L or secessus Ue scs ABX ALPHALYSE 360 0 36L reagents ABX MINIPACK LMG 4 2L Calibrators leaflets msds Latest versions of these documents are available on The CD ROM RAXO55 delivered with your instrument provides Reagents Controls and 4 www horiba com 1 6 Calibration Automatic Calibration procedure Direct entering of Calibration Coefficients 1 7 Measurements and Computation Impedance change for WBC RBC PLT Spectrophotometry for HGB Impedance change for LYM MON GRA Computation from stored Data that was directly measured for MCV MCHC MPV LYM MON GRA 1 8 Outputs Hard Copy printing External output RS232 ABX Micros User Manual RABO42IEN 5 ABX Micros GO 1 9 Display LCD Screen iieri 2 Lines of 40 characters backlighted 1 10 Barcode Reader Options 8 EAN 13 39 128 ITF 20f5 CODABAR STF 93 with or without Checksum 2 Physical Specifications 2 1 Power Requirements Power supply 100V 240V 10 50 60Hz Power Consumption Maximum 65W a In use 65W Stand by mode 35W e teat output 197Kj h 187BTU h 2 2 Operating Temperature Humidity 18 to 32 C 65 to 90 F Maximum relative Humidity 80 for temperatures up to 31 C 88
32. Press the Enter key Select one of any 4 operator ID s to be edited 4 Alphanumeric characters can be typed in Use the Number keys to enter up to 4 numbers or use the Up or Down arrow keys to enter Alphabetical characters Press the Enter key Use the Up or Down arrow keys to select the next operator ID to be edited Repeat the same steps through to edit the remaining operator ID s 4 2 Changing the User Password The use of this password allows the operator to Change the Calibration Coefficients Enter the Special functions menu Change the Password itself Changing operator Main Menu 5 Setup 3 Special Press the Enter key Enter system default Password 123 or the one defined by the operator Press the Enter key 2 Chg Password then press the Enter key Use the Number keys to enter any combination of 3 numbers Press the Enter key to accept the password change Press the Esc key to save the previous password 10 RABO42IEN User Manual ABX Micros GO Setup Special Functions 4 3 Choosing Startup Cycle The Startup cycle is used daily prior to any normal operation to ensure that detergent from the Standby cycle is completely rinsed out of the system It includes a Background count which must be verified prior to any analysis of samples This is necessary to ensure that there are No extraneous interferences that may be detected as background
33. Quality Control Without the use of a Smart Card pay close attention to the Result parameter Limits if the system was programmed to print out the limits These limits Are not Quality Control limits These limits are the ones that were es tablished in the setup menu See Section 5 3 Laboratory Limits page 5 7 Verify your control results with the Assay sheet that comes with the control material Verify that each Control level parameter is within its assayed limits 1 2 Q C Automatic With Q C Smart Card 1 Remove the Quality Control blood from the refrigerator and bring it to room temperature Entering QC Automatic Main Menu 2 QC 1 Automatic This menu will move the operator through the automatic quality control process once the Smart Card is inserted Operator selection Lot identification Expiration date etc will be displayed between each step of the process 2 Insert the Quality Control Smart Card into the card reader with a firm push until you hear it click into place The ABX Micros will only accept the Quality Control Smart Card while in the Q C program It will not accept 1 A Q C card that has expired 2 A Memory Card If you have the correct card and have error messages contact your local HORIBA Medical Technical Support Representative for further instructions regarding this issue 2 RABO42IEN User Manual ABX Micros GO Quality Assurance Quality Control
34. Results page 5 65 1 2 6 Accepting or Rejecting QC Results The results from the control blood are compared to Assayed ranges stored on the Quality Control smart card If any of the parameter results are Out of Range an H High or L Low will be shown on the display and on the printout as well ABX Micros User Manual RABO42IEN 5 ABX Micros GO If a third counting sequence is initiated during the analysis cycle and a specific parameter is in question a dollar sign or a star will be shown on the display next to the parameter and the run will automatically be Rejected You MUST rerun the control blood if the display indicates RUN REJECTED PRESS A KEY TO CONTINUE If the HGB Blank is not within acceptable limits an Exclamation is displayed next to HGB and the run will automatically be rejected 1 2 6 1 Accepting results Accepting QC results Results are within acceptable limits No alarm has been triggered out Press the Esc key Valid Low is displayed Press Enter key to valid If the operator Accepts the results by pressing the Enter key they will be stored on the QC Smart card and the display will return to SELECT LEVEL as described in 1 2 3 Select commercial control level page 3 Use the Up or Down arrow keys to select the next control level for analysis 7 Once the next level has been selected Press the Enter key to load that control lev
35. TR FROM TO page 20 The ability to erase all the samples stored and re use the card if necessary 8 83 Clear Card Erasing Results from the Card page 21 To transmit your results from the memory card to a printer or to a host computer 8 3 Transmission of Results page 18 8 1 Memo On Off Turning Memo Card On off Main menu 5 Setup 7 Memo Card 1 Memo Select either 1 to enable the use of the Memory card for sample results storage or 2 Memo OFF to disable the card Press the Enter key to confirm the selection CARD will appear on the display when you start a sample analysis cycle You must w 1 If you choose 1 and are not using the memory card a message NO SMART use a memory card when analyzing samples If you do not want to use a memory card ABX Micros User Manual 421 17 ABX Micros GO make sure that the Memo card sub menu is selected for 2 MEMO OFF 2 If the STANDARD ID Mode see 4 7 Choosing sample identification mode page 14 was previously selected before turning the memo card function On the ID mode will automatically change to US mode 8 2 Running Patient Samples 1 Place the sample beneath the sample probe and press the manual sample bar to start the cycle or press the Start key to start the cycle Entering sample identification Enter the sample identification Up to 13 Alphanumeric characters U
36. The Lymphocyte percentage is determined according to the WBC count and the number of Lymphocytes The presence of NRBC certain parasites and erythrocytes that are resistant to the Lysing action may interfere with an accurate LYM count Limitations listed for the WBC count pertain to the LYM 95 count as well 4 3 13 MON 4 Monocyte count Absolute Number The Mononuclear cell count is derived from the WBC count The percentage of Large Lymphocytes Atypical Lymphocytes Lymphoblasts and an excessive number of Basophils may interfer with an accurate Monocyte count 4 3 14 MON Monocyte Percentage The Monocyte percentage is determined according to the WBC count and the number of Monocytes The presence of Large Lymphocytes Atypical Lymphocytes Lymphoblasts and an excessive number of Basophils may interfere with an accurate Monocyte count 4 3 15 GRA Granulocyte count Absolute Number The Granulocyte cell count is derived from the WBC count The excessive presence of Eosinophils Metamyelocytes Myelocytes Promyelocytes Myeloblasts and Plasma cells may interfere with an accurate Granulocyte count 4 3 16 GRA Granulocyte Percentage The Granulocyte percentage is determined according to the WBC count and the number of Granulocytes The excessive presence of Eosinophils Metamyelocytes Myelocytes Promyelocytes Myeloblasts and Plasma cells may interfere with an accurate Granulocyte 95 count 18 RABO42IEN
37. User Manual ABX Micros GO Specifications Reagent Specifications 5 Reagent Specifications Do not use the instrument operational caps when reagents are left off the instrument bloods specially designed for use with the ABX Mlicros GO analyzers The use of products not recommended by HORIBA Medical may give erroneous results or instrument operation problems Contact your local HORIBA Medical center for all information regarding the recommended products w HORIBA Medical Manufactures and Markets Reagents Calibrators and Quality Control The HORIBA Medical reagents specified for this instrument have been approved in accordance with the European Directive 98 79 CE Annex III for in vitro medical devices Refer to Reagent Leaflets for all reagent specifications calibrators leaflets msds Latest versions of these documents are available on CD ROM 55 delivered with your instrument provides reagents controls and 4 www horiba com Allow your reagents to return to room temperature before use to avoid gas bubble emissions Never pour the remaining quantity of a reagent previously being used into the new reagent replacing it This will eliminate any cross contamination to the new Reagent Never leave a reagent container open during use Use the appropriate caps provided with the instrument Order new reagent caps if lost or misplaced Check with your shipping company and verify that your reagent shipment h
38. blood cells LYM Lymphocyte Percentage LYM Lymphocyte Absolute number MON Monocyte Percentage MON Monocyte Absolute number GRA Granulocyte Percentage GRA Granulocyte Absolute number RBC Red blood cells HGB Hemoglobin HCT Hematocrit MCV Mean Corpuscular Volume MCH Mean Corpuscular Hemoglobin MCHC Mean Corpuscular Hemoglobin Concentration RDW Red cell Distribution Width PLT Platelets MPV Mean Platelet Volume PDW Platelet Distribution Width PCT Plateletcrit WBC RBC and PLT Distribution Curves PCT and PDW have not been established as indications for this product in the United Q States The use of PCT and PDW should be restricted to Research Use Only 4 1 2 Throughput Analysis Approximately 60 Samples hour 4 RABO42IEN User Manual ABX Micros GO Specifications Technical Specifications V1 7 0 1 3 Memory Capacity Smart Cards Last sample ONLY Internal Memory capacity 60 samples eere Memory Smart Card option 499 samples ecciesie Quality Control Smart Card option 1 4 Statistics and Quality Control Extended Quality Control package Optional Quality Control Smart Card option 1 5 Reagents 3 Reagents or 1 Pack of Reagents Diluent ABX MINIDIL LMG 10L ABX MINICLEAN 1L ABX MINILYSE 1L or EESTI E ABX
39. card A Maximum of 33 runs can be stored on QC Smart Card 1 complete QC RUN contains all 3 levels of controls Low Normal and High analyzed 1 time each When the card is full you must insert a New Card and press the Enter key to accept the new card information 1 2 2 Select Operator Once you have accepted the QC Smart card information the display will prompt you to select an Operator 0P Selecting operator Up amp Down arrow key to select one of 4 operators Press Enter key The chosen operator is shown by a star 1 2 3 Select commercial control level Select level of commercial control you would like to analyze first The display is as indicated Selecting Level Up amp Down arrow key to select one of 3 levels Low Normal or High Press Enter key to accept this level A message LOADING LEVEL PLEASE WAIT will be displayed The information on the QC Smart card is read at this time After the information is read off of the card ABX GO will ask if you want to run the level of commercial control selected as indicated on the display ABX Micros User Manual RABO42IEN 3 ABX Micros GO 1 2 4 Running Control blood 3 Verify that the lot number on the screen matches the lot on the Commercial control blood 4 Once the Control blood has equilibrated to room temperature Gently and thoroughly mix the level Follow the product instructions that come with the
40. cause erroneous values 4 3 7 MCHC Mean Corpuscular Hemoglobin Concentration The MCHC is determined according to the HGB and HCT values The Limitations listed for HGB and HCT will have an effect on the MCHC and may cause erroneous values 4 3 8 RDW Red cell Distribution Width The Red blood cell distribution width is determined according to the RBC count The red blood cells pass through a Micro aperture that will generate electronic pulses as the cells pass through it These pulses are then Grouped according to size Thresholded and calculated to form a Histogram Distribution curve This distribution curve is then used to calculate the distribution of the Red blood cells as a percentage of the curve This curve is then used in determining the RBC size abnormalities as in Anisocytosis Agglutinated Red Blood cells May cause a falsely low RBC count and erroneous RDW s Blood samples containing the agglutinated RBC s may be detected by observing abnormal MCH and MCHC values as well as examination of a stained blood smear 16 RABO42IEN User Manual ABX Micros GO Specifications Limitations Nutritional Deficiency or Blood Transfusion May cause elevated RDW results due to Iron Vitamin B12 or Folate conditions High RDW s may also be present from Bi modal RBC distribution from Transfused Blood This will be detected by the RBC Histogram showing 2 distinctive peaks on the distribution curve 4 3 9 PLT Platelets
41. grounding to the facilities electrical ground If you are unsure of the outlet grounding contact your facilities engineer to verify the proper outlet ground 3 4 Humidity temperature conditions The ABX Micros GO must operate between temperatures of 18 to 32 C 65 to 90 F Maximum relative humidity 80 for temperatures up to 31 C 88 F If it is stored at a temperature less than 10 C 50 F the instrument should stand for 1 hour at the correct room temperature before use 3 5 Electromagnetic environment check ABX Micros GO has been designed to produce less than the accepted level of electromagnetic interference in order to operate in conformity with its destination allowing the correct operation of other instruments also in conformity with their destination In case of suspected electromagnetic noise check that the instrument has not been placed in the proximity of electromagnetic fields or short wave emissions Radar X rays Scanners Cell phones etc 3 6 Environmental protection 3 6 1 Disposable used accessories and consumables Must be collected by a laboratory specialized in elimination and recycling of this kind of material according to the local legislation 3 6 2 ABX Micros GO instrument disposal It should be disposed of in accordance with local legislation and should be treated as being contaminated with blood The appropriate biological precautions should be taken If any doubt please
42. noise which will affect the cell count See Section 3 1 3 Instrument Startup page 3 3 for more information regarding Startup This Special functions sub menu will allow the operator to choose between an Automatic or a Manual Startup 1 Auto will automatically run a Startup after the instrument warmup period once the ABX Micros has been powered ON 2 Manual will allow the operator to Manually press the Startup key to initiate the Instrument Startup cycle after instrument warmup Choosing Startup cycle Main Menu 5 Setup 3 Special Press the Enter key Enter system default Password 123 or the one defined by the operator Press the Enter key 3 Startup Select between 1 Auto 2 Manual Press the Enter key to accept the change once you have made your selection The indicates the current selection 4 4 Setting Autocleaning frequency This sub menu allows the operator to change the cycle frequency of the automatic cleaning cycle which occurs when the cycle number programmed has been reached The Default Cleaning cycle number is factory set to 50 analysis cycles The user has the option of changing this number from 1 to 99 999 This Automatic Cleaning cycle involves the use of the solution ABX Miniclean which is an enzymatic cleaner This solution breaks down protein buildup in the counting chambers and apertures the mode for startup press the Esc key until you return to the Ma
43. operator to print out a specified group of sample results starting from a specified number and ending with a specified number 1 Place the Memory card in the reader 20 RABO42IEN User Manual ABX Micros GO Setup Memory Card Printing from to Main menu 5 Setup 7 Memo Card 6 TR From To 1 Begin and press the Enter key Enter the wished starting Memo Number Press the Enter key 2 End and press the Enter key Enter the Ending Memo Number Press the Enter key 3 Send Result and press the Enter key to send the specific group of results to the printer and or the host computer The specific group of sample results will now print out individually on separate sheets of paper 8 8 Clear Card Erasing All Results from the Card This Memory card sub menu will allow the operator to delete all the Patient sample results from the card 1 Place the Memory card in the reader Erasing All results Main menu 5 Setup 7 Memo Card 7 Clear Card Press the Enter Press the Esc key until you return to the MAIN MENU performing this function This clear card function deletes all results no partial clearing 1 It is highly recommended to print out all the complete results from the card before These results can not be retrieved at any time ABX Micros User Manual RABO42IEN 21 ABX Micros GO 22 RABO42IEN User Manual ABX Micros GO Maintenance amp Troubleshooting Contents 1 Ma
44. representative w Calibration results having Error flags such as or for HGB will automatically be 4 Place the cap back onto the vial gently and thoroughly mix the material for the next calibration sample run 5 Run the remaining calibrator samples as described in 2 2 5 Running calibrator page 13 When the last sample result has been validated the ABX Mieros GO calculates the statistical calibration factors for each parameter These statistical calculations include the Mean Target Coefficient of Variation Percent difference between the Target value and the Mean Previous Calibration coefficients and the New Calibration Coefficients The Status will indicate on the printout if a parameter has Passed or Failed Calibration ABX Micros User Manual RABO42IEN 13 ABX Micros 6O 2 2 7 Verify Calibration 1 Once the calibration is complete and has Passed the Calibration criteria Press the Esc key until you have returned to the Main Menu 2 Run the remaining Calibrator material 3 times as a regular patient analysis Remember to gently and thoroughly mix the material between each sample run 3 When each cycle is complete record the results Calculate the Total and Mean values for each parameter listed Now compare the Mean value for each parameter to the Assay Mean values and ranges listed for the ABX Micros Verify that all the calculated parameters fall within the specific parameter Ranges o
45. should be restricted to indoor location use only This instrument is operational at an altitude of maximum 2000 meters 6000 feet The ABX Micros 60 is designed for safety from voltages surges according to INSTALLATION CATEGORY II and POLLUTION DEGREE 2 IEC 61010 1 Please contact your local HORIBA Medical representative if use conditions do not comply with the recommended specifications 3 2 Location The ABX Micros GO should be placed a clean and leveled table or workbench Please note that the ABX Micros GO printer and reagents weigh approximately 30 kilograms 66 lbs Avoid exposure to sunlight ABX Micros User Manual RABO42IEN 7 ABX Micros GO Place your instrument where it is not exposed to water or vapor Place your instrument where it is free from vibration or shock Place your instrument where an independent power receptacle can be used Use a receptacle different from the one used by a device that easily generate noise such as a centrifuge etc Provide a space of at least 20 cm 8 inches at the back of the instrument for arranging the power cable and tubings The power switch and input voltage supply connection should always be accessible When positioning the system for operational use leave the required amount of space for easy accessibility to these items 3 3 Grounding Proper grounding is required when installing the system Check the wall outlet ground earth for proper
46. steps hould be carried out in sequence as described below 2 2 1 System Operations The ABX Micros GO software identifies most of the mechanical or hydraulic problems A Me chanical problem gives an alarm message and stops the current cycle in progress A hydraulic problem can be noted by parameter and or morphology flags The Waste sensor also gives an error message if a hydraulic problem exists If this is the case Power OFF then ON the system and run a Startup If the problem persists during or after startup identify the source of the malfunction and ini tiate the appropriate troubleshooting procedures 2 2 2 Reagents If your Background count is unacceptable Quality Control values are out of range or your patient results are suspicious Reagent deterioration or contamination may be suspected Replace your reagents see 1 2 Reagent connections page 4 and perform a Concentrated Cleaning procedure see 1 3 6 Concentrated Cleaning page 11 If the background count is acceptable but the Quality Control values are still out of range or patient results are still suspicious continue with the indentification procedure If replacing the reagents performing a concentrated cleaning procedure does not correct the background count problem call your local HORIBA Medical Technical Support Representative for further instructions ABX Micros User Manual RABOA42IEN 17 ABX Micros GO 2 2 3 Precision In order to ve
47. the cell is the more resistance it has The smaller the cell is the less resistance it has The voltage which measures the cells is proportional to the cell size The larger the cell the higher the voltage will be The smaller the cell the lower the voltage will be These electronic voltages vary in pulse size as cells pass through the aperture The pulses are then channeled according to pulse size The pulses are then thresholded grouped then mathematically calculated to create a numerical value for the determination of 5 and PLT s 2 3 1 1 Results A certain amount of cells will pass through the Calibrated Micro aperture within a specific time frame They are then measured by pulse height Thresholded grouped by size and Mathematically calculated along with the Calibration Coefficient to give a final numerical value for both RBC s and PLT s 2 3 1 2 RBC and PLT Histograms The RBC and PLT Histograms are determined by thresholding of the electronical pulses These pulses are then grouped according to size by channeling the pulses into the correct size category The electronic pulses are smoothed mathematically and plotted on a graph il 1 29 Pulse Heig Fig 2 2 Cells passsing through the aperture creating electronic pulses Number of cells F Cell size Fig 2 3 RBC Pulses Musa REM according to the number and the size of the cells 6 RABO42IEN User Manual ABX Micros Description amp
48. their limits 13 Re run the Quality Controls to verify correct results 1 7 2 Replacing the Sample Probe Procedure 1 Enter the service Menu Entering service menu Main menu 4 Service 2 Open the main door of the ABX Micros GO see 1 3 2 Cover dismantling page 8 3 Now press the Esc key to open the tube holder door 4 Hold the sample probe mounting bracket on the upper right edge and move the sample probe Downwards until you can see the top of the probe and sample tubing 5 Remove the tubing from the top of the sample probe 6 Remove the sample probe Retaining Clip Pull the clip out horizontally towards the front of the analyzer 7 Hold the sample probe mounting bracket on the upper right edge and move the sample Upwards until the top of the probe is just below the front panel 8 Very carefully pull the sample probe slightly out of its retaining slot 9 Now hold the sample probe around the retaining collar very carefully lift up the probe so that it is free from the white needle guide Be carefull when placing the probe Try to maintain a vertical position of the probe when inserting it into the white needle guide The sample probe is fragile and may bend if not inserted into the needle guide correctly 10 Place the new sample probe in the white needle guide 11 Place the retaining collar of the probe into its slot 12 Hold the Sample probe mounting bracket on the upper right edge and mo
49. to the number of cells counted in the detection zone in comparison to the total number of Monocytes 3 The G1 flag indicates an excessive number of cells in 160fl to 2200 zone The patholog ical elements which may be found in this area will include Eosinophilia too many Eosinophils Myelocytes Neutrophil polynucleose ABX Micros User Manual RABOA42IEN 17 ABX Micros GO This flag corresponds to the number of cells counted in the detection zone in comparison to the total number of Granulocytes 4 The G2 flag indicates an excessive number of cells in the 220fl to 2508 zone This flag makes it possible to follow an abnormal Granulocyte peak displacement Some of the cell variances will include Anomalies in the cell membrane of the Granulocytes Possible Lyse flow error Fluidic errors 014 blood after 6 to 8 hours unrefrigerated Granulocyte cell size less than 250fl 5 The G3 flag indicates an excessive number of cells larger than 400fl The pathological elements which may be found in this area will include Metamyelocytes types of Large Immature Cells This flag corresponds to the number of cells counted in the detection zone in comparison to the total number of Granulocytes This cell count will be higher than the set level should be Manually verified by the examination of a stained peripheral blood smear for the presence of pathological elements As a result of
50. value parameter mean value x Current parameter coeff New parameter coeff After manually editing the calibration coefficients it is highly recommended to run Quality Control Verify that all levels of control material are within their specified parameter ranges Verify that there are no error flags H L for HGB associated with all levels of Quality control results Calibration Coefficients are as listed WBC RBC HGB HCT 18 RABO42IEN User Manual ABX Micros GO Quality Assurance Calibration PLT MPV RDW COEFF PDW COEFF PCT and PDW are not available in the United States These parameters are strictly used for research and investigational purposes only 2 2 13 1 Print Coe ficients Printing calibration coefficients Main menu 3 Calibration 2 Coefficients 2 Print Coeff The current calibration coefficients will automatically printout as indicated COEFFICIENTS DATE 01 20 2002 TIME 14 26 WBC RBC HGB HCT MPV CURRENT 0 97 0 88 1 13 1 08 0 95 0 92 RDW COEFF 1 00 PDW COEFF 1 00 Fig 4 6 Calibration Coefficients printout 2 2 14 Calibration Coefficient limits After any calibration has been performed on the ABX Micros GO Verify that all parameter calibration coefficients are within their specified ranges as indicated Tab 4 3 Calibration Coefficient limits Parameters Coefficient limits Minimum 0 89 0 73 0 83 0 87 0 99 0 75 0 75 0 75 Target 1 09 0 89 1
51. 0118 results 6 Flags These Instrument flags and alarms can be classified in 3 different groups 1 Results exceeding normal limits See 6 1 Normal Limits page 15 2 Flags linked to results that exceed the linear range of the instrument or leading to Rejected Analysis See 6 2 Flags causing analysis reject page 15 3 Flags and alarms linked to the morphology of a blood cell population See 6 3 Morphology Flags page 17 6 1 Normal Limits The H flag located next to a parameter result indicates that the value is Above the Upper limit set by the operator Section 5 3 Laboratory Limits page 5 7 The L flag located next to a parameter result indicates that the value is Below the Lower limit set by the operator 6 2 Flags causing analysis reject These flags are shown in different ways as indicated 6 2 1 Results Exceeding Linear range page 15 Results associated with an Asterisk 6 2 2 Results Rejected page 16 Dollar sign 6 2 3 Results Comparable page 16 Exclamation mark for HGB 6 2 4 HGB Blank Reference page 16 6 2 1 Results Exceeding Linear range Tab 3 1 Displayed results on screen Parameters Linearity Visible Range gt Visible Range limits 10 result result D RBC x10 mm result result D DIL PLT x105 mm HGB gt 2q dL result result D DIL PLT x10 mm HGB
52. 1 9 6 0 Cal Photometer 16 2 0 5 Backflush 7 Waste Handling Procedure If required waste can be neutralized before being discarded Follow your laboratory s protocol when neutralizing and disposing of waste Dispose of the waste container according to the local or national regulatory requirements protection etc Follow your local and or national guidelines for biohazard waste When disposing of waste protective clothing must be worn lab coat gloves eye disposal 20 RABO42IEN User Manual ABX Micros GO Description amp Technology Contents ale Ts Q 2 2 IENEUCIIEMC 2 2 1 2 Front view covers opened 2 2 1 3 Left side view covers opened 2 3 2 Technology 15 iioi es ea Eee beh ceessuseeiscescescccseesccuvessacscescsctecds Se ERES PR VEN ERU 2 3 PRIEST MEC 2 3 LRL MEET 2 4 2 2 1 iU 2 4 bitis ots D mu esae ME EE Ud 2 4 2 3 CBC Measurement Principles 2 5 RN Da 2 5 2 372 IO E 2 7 253235 UMr 2 8 2 3 4 MCV 8 MCHE 2 8 253252 RDW see vex oye envase opas diu sa TORVT LIV 2 8 LHEFJN A
53. 2 numbers and press the Enter key to save the new date Press the Esc key to exit the Date Time Menu 6 Host Computer Options The ABX Micros GO is capable of transmitting data to an external computer via the RS 232 interface connection on the back panel of the analyzer ABX Micros User Manual RABOA42IEN 15 ABX Micros GO 6 1 Host Communications 4 different Output formats are available 1 Format ARGOS No character identifiers 2 Format R amp D No character identifiers 3 Format ABX with character identifiers 4 TR OFF Transmission Off Setting output format Main Menu 5 Setup 6 Host options 1 Host Comm Select between the 4 above formats Press the Enter key to accept that specific output format 6 2 Baud Rate This sub menu allows the operator to select the rate of transmitted data to the host computer There are 5 different rates to select from 1 300 2 1200 3 2400 4 4800 5 9600 Setting Baud rate Main Menu 5 Setup 6 Host options 2 Baud rate Select between the 5 above rate Press the Enter key to accept that specific rate 6 3 Transmission This sub menu will allow the operator to send the last sample results in memory to the Host computer as a transmission acceptance verification This function is mainly used to verify transmission from the ABX Micros GO to a host computer Setting Baud rate Main Menu 5 Setup 6 Host options 3 Transmission Press the E
54. ABX Micros GO Workflow Results 5 1 4 Results Printout 5 1 4 1 US Mode RESULTS DATE 01 20 2006 TIME 09 25 ID SMITH 1234567 SEQ 27 STARTUP PASSED Plt Flags WBC 10 0 103 mm MCV 90 um RBC 4 90 105 mm MCH 30 6 Pg HGB 15 0 g dl MCHC 34 1 g dl HCT 43 9 PLT 287 10 mm Fig 3 1 US mode printout Printed information is as follows 1 The Date the sample was analyzed 2 The Time the sample was analyzed 3 The Sample Identification that the Operator had entered either Manually or Barcode 4 The Sequence number of the sample run 5 The Instrument STARTUP status 6 The PLT flags if any were reported 7 The 8 Parameter CBC results with Limit flags and units increases by increments of 1 each analysis cycle sequentially this sequential number The sequence number is updated to the number 1 each calendar day the number 4 can not be modified by the operator ABX Micros User Manual RABO42IEN 11 ABX Micros GO 5 1 4 2 Standard Mode RESULTS DATE 01 20 2006 TIME 09 25 RUN 12345 SEQ 27 STARTUP PASSED Plt Flags WBC 10 0 103 mm MCV 90 um RBC 4 90 106 mm MCH 30 6 Pg HGB 15 0 g dl MCHC 34 1 g dl HCT 43 9 PLT 287 10 mm Printed information printed is as followed 1 The Date the sample was analyzed 2 The Time the sample was analyzed 3 The Sample RUN that was entered by the Op
55. B g dL 2 0 27 0 26 26 30 03 3 96 1 8 82 3 0 80 80 90 20 39b Source 510K submission K030799 A for HGB 2 g dL and RBC gt 0 5x10 mm 3 B for HGB lt 2 g dL and RBC gt 0 5x10 mm 3 10 RABO42IEN User Manual ABX Micros GO Specifications Summary of Performance Data 3 5 Carry over Carry over was tested by analyzing samples with High Concentrations of WBC s RBC s HGB and PLT s Each sample was analyzed in triplicate followed by 3 background cycles The Carry over is calculated by using the following formula Carry over Background1 Background3 Sample3 Background3 X 100 Tab 1 10 Blood count Level 63 0 7 58 23 4 Carry over Actual 0 3 0 00 0 0 0 0 9 Carry over Claimed lt 0 5 0 59 0 590 lt 0 5 3 6 Normal Ranges These Normal ranges were established from a study performed in Somerville NJ U S A This study encompasses the central 95 of the values in the distribution of 43 Normal Healthy and Drug Free individuals These Ranges are as followed Tab 1 11 WBC 105 mm 4 7 9 6 4 9 12 3 Lymphocytes 9 23 47 19 41 Monocytes 90 3 6 2 6 Granulocytes 49 74 53 79 RBC 10 mm3 4 37 5 63 3 90 5 10 HGB g dl 13 5 16 5 12 0 15 0 HCT 41 50 37 45 MCV um 83 101 84 96 MCH 26 34 27 34 MCHC g dl 32 35 32 35 RDW 12 16 12 14 PLT 105 mm 145 355 150 330 MPV um 7 3 9 0 8 10
56. CT PLT MPV RDW COEFF PDW COEFF 2 Print Coefficients Menu SERVICE see 1 3 1 Menu Service overview page 8 Menu SETUP See Section 5 1 Setup overview page 5 2 ABX Micros GO User Manual RABO42IEN 25 ABX Micros GO 26 RABO42IEN User Manual ABX Micros GO
57. HORIBA Medical ABX Micros 60 Hematology Analyzer User Manual Ref RABO42IEN Explore the future Automotive Test Systems Process amp Environmental Medical Semiconductor Scientific HORIBA ABX Micros GO User manual RABOA2IEN vo HORIBA ABX SAS B P 7290 34184 MONTPELLIER Cedex 4 FRANCE ABX Micros GO 1 Revisions Tab 1 User Manual revisions CE WE MNA note revision RAH911AA V1 4 05 23 02 Bb RAH911AA V1 4 1 3 6 11 04 02 Ca RAH939AA V1 6 All 12 10 02 Cb ECR1354 V1 6 UL correction 1 01 09 03 Da RAH986AA V1 6 CE IVD Norms Intro 1 16 09 03 EEN RAN153AA V1 6 HORIBA Medical All 09 03 05 see 10 1 Corrections associated to FEN RAN252AA V1 7 0 V1 7 0 Software version page Intro 15 06 06 duction 18 vzo DE new version page 19 HEN IEN ECR4015 V1 7 0 New cTUVus certification Intro 1 09 07 09 This document applies to the latest software listed and higher versions 4 When a subsequent software version changes the information in this document a new electronic issue CD ROM and or online help is released and supplied by HORIBA Medical To update a paper document please contact your local HORIBA Medical representative HORIBA ABX SAS B P 7290 34184 MONTPELLIER Cedex 04 FRANCE Tel 33 0 4 67 14 15 16 Fax 33 0 4 67 14 15 17 4 RABO42IEN User Manual ABX Micros GO Introduction 1
58. L RBC 2 090 5 106 uL HGB 1 59 15 g dL HCT 2 09 45 PLT lt 5 0 300 x 10 uL Source 510K submission K030799 ABX Micros User Manual RABO42IEN 9 ABX Micros GO 3 3 Precision Repeatability Based on 20 consecutive samplings from 1 Fresh Normal Whole Blood without any alarms Tab 1 8 im WBC 2 59 10 0 x 10 uL RBC lt 2 0 5x 10 uL HGB lt 1 5 15 g dL HCT 2 09 45 PLT lt 5 0 300 x 10 uL 3 4 Linearity Linearity range The Manufacturer s tested linearity zone of the instrument using linearity kits and or human blood Linearity limits Maximum and minimum values within the instrument returns no dilution alarm Visible Range Range values given by the instrument These values above linearity limits are given as an indication They are given associated with a D flag This Visible range is outside Manufacturer s range Linearity Kits Linearity was tested using available Low Range and Full Range Linearity Test kits The Test kits were analyzed and data was computed according to the Manufacturer s instructions Human Blood Linearity was also obtained on human blood using a minimum of 5 dilution point The results of this study are as followed Tab 1 9 WBC 10 mm 0 5 122 0 100 100 150 0 3 5 RBC 10 mm 0 2 8 7 0 8 8 18 0 00 3 PLT 102 mm 10 2327 0 2200 2200 6000 10 1090 103 3 25 4990 0 4000 4000 6000 10 10 HG
59. LYSE bottle Close the compartment cover Fig 6 1 Reagent bottles mandatory to use specific LYSE LMG and MINIDIL LMG reagents 2 The Diluent container will be located on the bench at the same level than the instru ment 1 When the ABX Micros GO is set up with the 16 or 18 parameters mode it is 1 2 2 Alphalyse 360 Open the pack pulling the flap A and open the level window B see Fig 6 2 Opening page 5 4 RABO42IEN User Manual ABX Micros GO Maintenance amp Troubleshooting Maintenance Fig 6 2 Opening Install the Alphalyse 360 as shown on Fig 6 3 Alphalyse 360 installation page 5 Fig 6 3 Alphalyse 360 installation 1 2 3 Reagent pack connection Remove the reagent output protections as well as the waste input protection Fig 6 4 Protections page 6 ABX Micros 60 User Manual RABO42IEN 5 ABX Micros GO Fig 6 4 Protections Install the pack into the compartment of the instrument Fig 6 5 Pack installation page 6 Push the pack down in order to plug correctly the pack on the male connectors Fig 6 5 Pack installation The free male connector must be plugged on the pack upper valve in order to receive the waste liq uids Fig 6 6 Waste connector page 6 Fig 6 6 Waste connector 6 RABO42IEN User Manual ABX Micros GO Maintenance amp Troubleshooting Maintenance In order to avoid leak problems it is recommended no
60. M HQ Chap 1 6 CEIvd approved reagents correction ccccceeesseeecccceesseeccccceeseeecceeeuneeeeeeeeeaeees Chap 1 19 Addition CD ROM reagent leaflets 55 eee eene Chap 1 19 Startup Background limits management on Chap 3 3 250 standard deviation replaced by SD in Chap 4 9 Calibration general recommendations Chap 4 11 18 RABO42IEN User Manual ABX Micros GO Introduction 10 2 Corrections associated to new version Introduction 2 Updated documents Copyright modified and eene Introduction 3 New warning about reagent Chap I 20 New values of reagent consumption nnne Chap I 20 New warning about risk of wastes eene Chap III 2 Limits of CV on Control blood Chap IV 8 ABX Micros User Manual RABO42IEN 19 ABX Micros GO 20 RABO42IEN User Manual ABX Micros GO Specifications Contents 1 Technical Specifications V1 7 0 1 3 1 4 rir m 1 3 1 2 Throughput Analysis eene nennen nnn nee enne enu 1 4 1 3 Memory Capacity Smart Cards
61. RBC PLT measurement ABX Micros User Manual RABO42IEN 3 ABX Micros GO 2 2 Dilutions 2 2 1 WBC HGB Tab 2 1 WBC HGB Dilution WBC HGB Dilution Initial blood volume 10 0uL Volume of ABX Minidil LMG 2100yl Volume of ABX lyse 500 1 Final dilution ratio 1 260 Tab 2 2 WBC Measurement WBC Measurement Method Impedance Aperture diameter 80 Count Vacuum 200mb Count period 2 x 5 seconds Temperature reaction ambient Tab 2 3 HGB measurement HGB measurement Wavelength 550nm Count period 2 x 5 seconds Temperature reaction ambient 10 of blood sample contained in the sample probe is pushed with 1 2ml of ABX Minidil LMG along with 0 5ml of ABX Minidil LMG from the outer probe into the WBC HGB Chamber 0 4ml of ABX Minidil LMG is added the WBC HGB Chamber making the diluent volume 2 1ml 0 5ml of ABX lyse is added to the mixture This makes the total dilution for WBC HGB 2 2 2 RBC PIT Tab 2 4 RBC PLT dilution RBC PLT dilution Initial Diluted blood volume 30ul 1 170 Volume of ABX Diluent 2500 1 Final dilution ratio 1 15000 Tab 2 5 RBC PLT measurement RBC PLT measurement Aperture diameter 50ul 4 421 User Manual ABX Micros GO Description amp Technology Technology Tab 2 5 RBC PLT measurement RBC PLT measurement Count Vacuum 200mb Count period 2 x 5 seconds Temperature reaction ambient 28 3yl of diluted blood is aspirated from the WBC chamber The n
62. See Section 6 1 3 6 Concentrated Cleaning page 6 11 2 Perform two blank cycles to check the cleanliness of the instrument 3 Check the repeatability of the instrument by running a fresh normal whole blood sample 11 times with no alarms Discard the first result and calculate the CV on the remaining 10 runs 4 Check that the CV calculated using the remaining 10 runs meets or exceeds the specifications in 3 2 Precision Claims page 9 5 Run a control blood and check that the values are within the acceptable limits If not run a new control blood If the values are still out of the acceptable limits and instrument is clean blank cycles in conformity with the values given in the manual and repeatability is correct Acceptable CV values carry out the calibration as described in 2 1 2 Calibration procedure page 11 2 1 2 Calibration procedure 1 Run at least 4 times Calibrator without taking the values of the first result into account see 2 2 5 Running calibrator page 13 2 Calibrate the instrument on the average of the last three results according to indications of the manual see 2 2 8 Calibration Passed page 15 3 Run 3 times again Calibrator to check the values 4 Confirm the calibration while passing a control blood the values have to be returned within acceptable limits 5 After about thirty numerations analyses of the day check that values of MCV MCH and MCHC are in conformity with the u
63. The ABX Micros GO will automatically read the card and display the Lot and Expiration date of the current card It is mandatory to verify that the Quality Control Smart card being used matches the instrument type Micros GO the Lot and expiration date of the Quality Control material being used for this program 1 2 1 QC Smart card messages NO SMART CARD INSERT NEW CARD means that card has not been inserted or incorrectly or there is technical failure with the reader NEW QC means that this card is being used for the very first time XX QC RUN When the card already has Q C data on it the display will show the next sample run for Quality control i e 18 QC RUN inplace of new QC This number indicates the next Q C run after the stored runs For example 1 complete QC RUN contains all 3 levels of controls Low Normal and High analyzed 1 time each QC DIFF means that there 15 difference between the QC index in the ABX Micros GO and the QC index on the QC Smart card This usually occurs when there is confusion between 2 QC Smart cards If the operator presses the Enter key the analyzer accepts the differences and automatically equals the indexes If the operator presses the Esc key the analyzer requests a new card reads the new card information and displays it SMART CARD FULL means that the QC Smart Card has reached its limit on stored QC data and cannot store anymore on that specific
64. Time 1 Chg time 2 Date format 3 Chg date 2 Results Options This sub menu will allow the operator to access and edit some of the following sub menu functions such as Reprint the result of the last sample in the system Memory 2 1 Reprint Results page 3 To select the Histograms to printed out 2 2 Printout page 4 To select the Unit of Measurement type 2 3 Units page 4 To select the type of printer 2 4 Printer Selection page 5 To select the Temperature to be printed out 2 5 Temperature Printout page 5 To select the Patient Parameter limits to be printed out 2 6 Print Limits page 6 select the LMG s Lymphocytes Monocytes and Granulocytes to be printed out Available only for ABX Micros 6GO 0S 0T16 or 0S 0T18 parameter analyzers 2 7 Print LMG Re sults page 6 2 1 Reprint Results Reprinting last results Main menu 5 Setup 1 Results 1 Reprint results usually the very last sample analyzed either a patient sample or a quality control level v The ABX Micros GO will only hold 1 result in the system memory This result is blood only A calibrator blood result is stored in an entirely different system format ABX Micros User Manual RABO42IEN 3 ABX Micros GO The last results in memory will automatically printout with the following information 9 Date and Time the associated Identification Sample run and Sequence Number Possible flags if a
65. X Micros GO Setup Laboratory Limits 3 Laboratory Limits Laboratory Limits are commonly known as normal patient ranges These Limits will vary with population and or geographical location The default limits set on the ABX Micros GO are based on a study of normal healthy and drugfree individuals Your limits may vary based upon the applications for intended use Available functions in this menu Changing the Low parameter Laboratory limits see 3 1 Results Low Limits page 7 Changing the High parameter Laboratory limits see 3 2 Results High Limits page 7 Printing the Current Laboratory limits see 3 3 Print Limits page 8 Changing all Morphology Flag limits see 3 4 Morphology Flag Limits page 9 Changing Laboratory limits Main menu 5 Setup 2 Chg Lab Limits Use the Up or Down arrow keys to select either 1 Low Limits step to 3 1 Results Low Limits page 7 2 High Limits step to 3 2 Results High Limits page 7 3 1 Results Low Limits Editing Low limits 1 Low Limits 1 WBC Low Press the Enter key Enter new value Use the key for placing the decimal point in the correct order Press the Enter key Select the next parameter to edit using Up or Down arrow key Repeat the same steps to modify values Press the Esc to return to the Chg Lab Limits Menu 3 2 Results High Limits Editing High Limits 2 High Limits 1 WBC High Press the Enter
66. a 7290 34184 Montpellier Cadex 4 FRANCE 83 4 87 1415 16 Fax 83 467 14 15 17 MODELE MODEL NUMERO DE SERIE SERIAL NUMBER secteur 100 240 V FREQUENCE FREQUENCY PUISSANCE R ATTENTION AFIN D EVITER LES RISQUES DE CHOC ELECTRIQUE NE PAS OTER LES CAPOTS ET LES TRAPPES D ACCES APPELER UN REPARATEUR QUALIFIE DEBRANCHER LE CABLE D ALIMENTATION SECTEUR AVANT TOUTE INTERVENTION VERIFIER QUE LA TENSION EST CORRECTE N UTILISER EN REMPLACEMENT QUE DES FUSIBLES DE MEME TYPE ET DE MEME CALIBRE CAUTION TO REDUCE THE RISK OF ELECTRIC SHOCK DO NOT REMOVE COVER OR BACK REFER SERVICING TO QUALIFIED SERVICE PERSONNEL DISCONNECT THE SYSTEM FROM SUPPLY BEFORE SERVICING USE ONLY WITH CORRECT POWER VOLTAGE REPLACE ONLY WITH SAME TYPE AND RATING OF FUSE Introduction Intended use The ABX Micros GO 05 0 15 a fully automated Microprocessor controlled Hematology analyzer used for in vitro diagnostics testing of Whole Blood specimens and Whole Blood component concentrates consider the Linear Range of the component parameter and its associated JJ Important When analyzing Whole Blood component concentrates you must parameters if any These concentrates may prematurely pollute the counting aperture when analyzing them It is suggested that you perform 3 Backflushes and or a Concentrated Cleaning after analyzing the concentrates The ABX Micros GO 05 0 is availab
67. ab operator of the pres Pathological cells will of course place themselves in different zones within the WBC 4 ence of these Pathological elements Results The Lymphocytes Monocytes and Granulocytes results are given as a percentage of the entire WBC count along with absolute numbers as well to reflect on the actual WBC count itself They are presented as followed LYM LYM MON MON GRA GRA 10 RABO42IEN User Manual ABX Micros GO Workflow Contents 1 Startup Checks EMT cs 3 2 1 1 Reagent level checks 3 2 1 1 1 Bottled UNITES esee RR ree exem ree 3 2 1 1 2 Minipack Units evertere Yn ee e eese ee Pene eus Tea Yea Eve rn aaas 3 2 1 2 Printer Power and On line Checks 3 3 1 3 Instrument Startup tiene reete S en arena en Yee du 3 3 1 4 Blood Sample Collection sees eeeeee esee e nennen 3 4 2 Daily Quality Control amp Calibration verification ecce esee eee eee eene 3 5 3 Sample selection and identification _ eee eene eee eee ne eene nnne 3 6 3 1 Sample identification modes eeesceeeeseeeeeeeeeee ee eene enne 3 6 31 1 US E M 3 6 3 1 2 Standard Mode ette ete taxe 3 6 4 Ru
68. ach analysis run this mode also allows the use of a barcode reader if applicable 3 1 1 1 US mode Without barcode reader Entering Identification Press the ID key on the front panel to enter the sample ID 13 alphanumeric Numbers and or Letters characters are available Letters can be entered by using the front panel Up and Down arrow keys Press the Enter key after each Alpha character entry The Number keys can be used up to 13 consecutive characters if No alpha characters are used before pressing the Enter key The sample Identification will be held in Memory until the cycle is complete 3 1 1 2 US mode With barcode reader Entering Identification Press the ID key Place the sample in front of the reader so that the Label can be identified When the reading is complete a Beep tone is heard and the label identification will be displayed on the LCD screen Press the Enter key to save the current identification Or press the Esc key to display the previous identification this setup the Barcode Reader must be configured on the main circuit board of the ABX Micros GO If you require a barcode reader for sample identification please contact your local HORIBA Medical Service Representative for installation and setup of this device w The barcode reader is a special setup function in the system configuration Before using 3 1 2 Standard Mode If the Standard Mode identification has be
69. actices as specified in OSHA Bloodborne Pathogen Rule 29 CFR Part 1910 1030 or other equivalent biosafety procedures 4 2 1 Sample collection and mixing When collecting blood specimens venous blood is recommended but arterial blood may also be used in extreme cases Blood collection must be placed in vacuum or atmospheric sample collection tubes For USA Only For additional information on collecting venous and capillary samples refer to NCCLS document H3 A4 and NCCLS document H4 A4 sept 1999 The sample collection tube must be filled to the exact quantity of blood indicated on the tube itself Any incorrectly measured blood sample collections will show a variation in results 9 4 2 2 Sample Stability Fresh Whole Blood specimens are recommended The ICSH International Committee for Standardization in Hematology defines a Fresh blood specimen as One processed within 4 hours after collection Well mixed Whole Blood specimens collected in EDTA anti coagulant and run within eight hours after collection provide the most accurate results for all parameters The white cell size distribution may shift when specimens are assayed between 5 and 20 Minutes after collection and more than 8 hours after collection Limitations ABX Micros User Manual RABO42IEN 13 ABX Micros GO 4 2 3 Anti coagulants and their effects on whole blood This is a list of commonly used anti coagulants used for whole blood collect
70. age indicates to start the analysis 2 Once the Control blood has equilibrated to room temperature Gently and thoroughly mix the level of control blood to be analyzed Follow the product instructions that come with the control kit for proper mixing 3 Remove the cap and place the vial beneath the sample probe raise the vial upwards so that the sample probe enters into the blood 4 Press the Start key or the Manual Sample Bar on the front panel to start the cycle When the analysis cycle is complete the results are displayed and printed out as shown Fig 4 1 QC results printout page 5 ABX Micros User Manual RABO42IEN 7 ABX Micros GO 1 4 Q C print targets only with Q C smart card This Q C sub menu allows you to print out the Assay ranges of all 3 levels of control blood from the 0 Smart Card 1 Insert the Q C Smart Card into the reader with a firm push until it clicks into place Printing targets Main Menu 2 ac 3 Print targets Lot and Exp Date are displayed Press Enter key The printout will show Low limit and High limit for each parameter for each assayed level of control HIGH NORMAL and LOW 1 5 Q C statistics only with Q C smart card This Q C sub menu allows the operator to print out all the stored cumulative data for all 3 levels on the control blood The information printed out will contain all the necessary statistical data for each level The levels ca
71. ameters are strictly used for research and investigational purposes Only 8 RABO42IEN User Manual ABX Micros GO Setup Laboratory Limits 3 4 Morphology Flag Limits The factory default flag values programmed on the ABX Micros GO were set based on a study of normal cell populations These Default values can be adjusted to accommodate specific populations and or geographical locations based on those spe cific studies It is highly recommended to maintain the default values unless popula tion and or geographical location studies are known Numerous factors can contribute to constant Morphology flagging If you are experiencing constant flagging Section 6 2 3 1 Problems on all Parameters page 6 19 Also see Section 1 4 3 Known Interfering Substances page 1 14 This sub menu allows the operator to adjust the Morphology flag percentages to the specific needs of the population and or geographical location All the Morphology flag percentages can be adjusted from 0 01 to 25 00 If you Lower the present Default percentages of the flags you will make the flagging criteria More Sensitive and may increase your flagging alarms on sample analysis If you Raise the present Default percentages of the flags you will make the flagging criteria Less Sensitive and may decrease your flagging alarms on sample analysis 3 4 1 Platelet Flags Factory Default adjustment values are as follows SCL 8 00 SCH 8
72. as not encountered important temperature differences during transportation Clean any reagent spillage with water as soon as possible in order to prevent Crystallization of the reagent and Oxidation of the metal parts of the instrument Never pour reagents into the laboratory waste water drainage system Follow Local National regulations for chemical waste disposal Apply neutralization procedures when necessary It is necessary to flush the reagent lines with distilled water then dry them when the instrument is going to be shipped to any location or will be left without operating for an extended period of time Contact your Local HORIBA Medical SERVICE CENTER for more information about this procedure These reagents are used for Invitro out side the body diagnostics ABX Micros User Manual RABOA42IEN 19 ABX Micros GO 6 Reagent Consumption Make sure a Startup and a Control Blood have been performed after a reagent replacement Reagent consumption is given in milliliters ml It has been calculated from an average on 100 cycles for a specific program version Program version V1 7 0 Tab 1 13 Reagent Consumption te cleaner nor 0 5 Startup 23 2 Standby 13 9 Analysis 15 8 0 5 0 9 yl Prime All Reagents 42 0 42 0 42 0 Prime Diluent 26 2 Prime Lyse 10 4 5 4 Auto Clean 15 9 0 5 13 8 Concentrated Cleaning 16 0 0 5
73. atest Calibration Lot Number The most current Calibration Coefficients and last calibrator Target values The most current RDW calibration coeff Most current instrument software version Type of analyzer Open or Closed tube system Reagent Pack Yes or No Yes for Reagent pack No for separate Reagents Startup mode Number of parameters that the instrument reports Cycle alarm On or Off audible tone Type of Unit Measurements Type of printer selected Result printout options with or without histograms Print out the LMG s Yes or No Print the Laboratory limits with the results Yes or No Type of Host Computer communications Barcode reader Yes or No Checksum with barcode reader Yes or No The date format MM DD YY or DD MM YY Sample Identification mode Smart Card reader Yes or No The Memo card option On or Off The Instrument Run mode set for USER and USER Only The Cycle Start mode Auto or Manual The temperature of the Diluent The last 5 digits of the Instrument serial number Complete number is on the back panel of the unit The Number of Startup cycles run The Number of Standby cycles run The number of CBC cycles run The number of cycles to be run before the cleaning cycle starts The User Password The Number of samples to be run during calibration Stepper
74. contact your HORIBA Medical representative service N department 8 RABO42IEN User Manual ABX Micros GO Introduction Working conditions Y European Legislation In accordance with the European Directive 2002 96 CE known also as W E E E instruments having the above symbol and sold into a European country by HORIBA Medical or an authorised representative must be disposed of and recycled correctly at the end of its useful life Due to the local changing regulations in each country please contact your local representative for detailed and upto date information on how to appropriately dispose of the instrument 3 7 Transportation and storage conditions Condition for storage and transportation Temperature from 20 C to 50 C Prior to the shipping of an instrument by transporter whatever the 3 destination an external decontamination of instrument must be carried out ABX Micros User Manual RABO42IEN 9 ABX Micros GO 4 Graphics and symbols Switch off position Switch on position Alternating current gud Manufacturer This product conforms to the EEC Standards and Directives named in the Declaration of Conformity In Vitro Diagnostic Medical Device Caution consult accompanying Biological risks documents g Up Fragile handle with care Keep dry Do not stack Temperature limitation Batch code Catalogue number Use by Consult instructions for use O IVD Reagent
75. control kit for proper mixing 5 Remove the cap and place the vial beneath the sample probe raise the vial upwards so that the sample probe enters into the blood 6 Press the Start key or the Manual Sample Bar on the front panel to start the cycle 4 RABO42IEN User Manual ABX Micros GO Quality Assurance Quality Control 1 2 5 QC results When the control analysis cycle is complete the results are displayed QC results review Use the Up and Down arrow keys to scroll through the results The control results are printed out as indicated ac DATE 01 20 2006 TIME 09 25 LOT 4 M211 LOW EXP DATE 03 20 2006 OPERATOR OP 1 Q C 02 SEQ 4 1 STARTUP PASSED WBC 2 3 103 mm3 1 7 2 5 MCV 67 63 71 RBC 2 36 10 mm 2 27 2 57 MCH 23 6 Pg 23 6 27 6 HGB 5 6 L g dl 5 7 6 7 MCHC 35 2 g dl 35 2 41 2 HCT 15 9 14 2 18 2 RDW 12 7 9 9 9 15 9 PIT 7010 mm 52 92 MPV 9 4 um 7 4 11 4 DIFF LYM 59 6 52 7 66 7 LYM 1 3 103 mm 0 9 1 7 MON 14 2 7 4 19 4 MON 0 310 mm 0 1 0 5 GRA 26 2 19 9 33 9 0 7 103 mm 0 2 1 0 RBC PLT i 30 100 230 10 30 Fig 4 1 QC results printout histograms and parameters are all dependant upon the initial instrument setup See Printed results may vary on the amount of data displayed on the printout Limits LMG s 4 Section 5 2 7 Print LMG
76. count 14 RABO42IEN User Manual ABX Micros GO Specifications Limitations Agglutinated Red Blood cells May cause a falsely low RBC count Blood samples containing the agglutinated Red blood cells may be identified by observing abnormal MCH and MCHC values as well as examination of a stained blood smear Cold Agglutinins IgM Immunoglobulins which are elevated in Cold Agglutinins disease may lower RBC and PLT counts and increase the MCV 4 3 3 WBC White Blood Cells Leukocytes WBC results that exceed the linearity limits of the system will require a Dilution of the blood sample Re assaying the diluted blood sample will help to obtain the correct assay value As in some Leukemia patients NRBC Immature Nucleated Red Blood Cells will be counted in the WBC White Blood Cell parameter If the number of Nucleated Red Blood cells is sufficient enough to activate an L1 Alarm such interference will be detected However a Manual differential white blood cell count performed on a stained blood smear will confirm the presence of NRBC s When NRBC s are present in the WBC count the formula for correcting the WBC parameter is as followed Corrected WBC Counted WBC s 100 100 of NRBC s 100 WBC Non lysed Red Cells In particularly rare instances the erythrocytes in the blood sample may not completely lyse when lysing reagent is added in the WBC Chamber These non lysed Red blood cells may be detected on
77. count These types of specimens should be re collected in Sodium citrate anticoagulant and re analyzed For Platelets Only 4 3 10 MPV Mean Platelet Volume Giant Platelets that exceed the upper thresholding of the platelet channels may not be counted as platelets consequently these larger platelets will not be included in the instrument s calculations of the mean platelet volume Blood Samples collected in EDTA will not maintain a stable Mean Platelet Volume Platelets collected in EDTA will swell with time and temperature Agglutinated Red Blood cells May trap Platelets causing an erroneous MPV result The presence of Aggultinated erythrocytes may be detected by observing abnormal MCH and MCHC values and by careful examination of a stained blood smear Very Small Erythrocytes Microcytes Erythrocyte fragments Schistocytes and White Blood cell fragments may interfere with the proper sizing and counting of the Platelets Chemotherapy May also affect the Sizing of Platelets ABX Micros User Manual RABOA42IEN 17 ABX Micros GO 4 3 11 LYM Lymphocyte count Absolute Number The Lymphocyte count is derived from the WBC count The presence of Nucleated Red Blood cells NRBC certain Parasites and erythrocytes that are resistant to the Lysing action may interfer with an accurate LYM count Limitations listed for the WBC count pertain to the LYM count as well 4 3 12 LYM Lymphocyte Percentage
78. d call HORIBA Medical Technical support Perform a Concentrated cleaning 1 3 6 Concentrated Cleaning page 11 re run sample Mix sample just before pressing the Manual sample bar for each sample GO User Manual RABO42IEN 21 ABX Micros GO 2 4 Troubleshooting System Operations Tab 6 5 Problem Noted Possible Cause Corrective Action No Power to the unit No Display on LCD screen Motor Errors on any motor Unit is powered Off and or power cord is disconnected from power source Possible blown power fuses Possible disconnection of cable to display Possible incorrect adjustment on LCD contrast Possible Motor failure Possible disconnected cable to motor on main board 22 RABO42IEN User Manual ABX Micros GO Power On unit and or plug in power cord to power source Call HORIBA Medical Technical sup port for assistance Call HORIBA Medical Technical sup port for instructions on re connection of cable Press DEL key and Period key si multaneously re adjust contrast Check motor operation using 1 3 7 Mechanical Checks page 11 Remove main cover of the unit check all connectors call HORIBA Medical Technical support for assistance Maintenance amp Troubleshooting Troubleshooting 2 5 Troubleshooting Specific ERROR Messages Tab 6 6 Error message Corrective Action Check and or replace reagent s Perform a concentrated cleaning 1 3 6 Concentrated Cleanin
79. disinfectant product and wipe the dirty surfaces Dry with a soft cloth Products having the following microbiological properties Bactericidal Fungicidal Active on Aspergillus fumigatus Active on Mycobacterium tuberculosis B K Antiviral VIH HBV and rotavirus Product Example validated by HORIBA Medical ANIOS detergent disinfectant WIP ANIOS ref 1316 424 5 Please also refer to the W H O World Health Organization guidelines Labo ratory Biosafety Manual 2nd edition for further information 1 1 3 2 Instrument internal cleaning Y Concentrated cleaning Counting chambers and hydraulics parts are decontaminated by using the Concentrated cleaning function as described in 1 3 6 Concentrated Cleaning page 11 Y Sampling probe Sampling probe must be decontaminated as follows 1 Prepare a solution of Sodium Hypochlorite to 100ml l 2 Fill a 5ml tube with this solution 3 Run 5 analyses on bleach Q Please also refer to the W H O World Health Organization guidelines Labo ratory Biosafety Manual 2nd edition for further information ABX Micros User Manual RABO42IEN 3 ABX Micros GO 1 2 Reagent connections 1 2 1 Bottle connections Lyse and cleaning reagents are placed inside the reagent compartment see Fig 6 1 Reagent bottles page 4 Install the reagent straws and the bottle stoppers Connect the blue tube to the MINICLEAN bottle and the white tube to the
80. e 2 2 4 Change number of calibration samples page 12 proceed as follows to run an analysis on calibrator Running calibrator sample Run Cal message is displayed Press the Enter key a prime cycle is launched first 1 Now gently and thoroughly mix the Calibrator material as indicated on the Instruction sheet that comes with the calibrator 2 Place the calibrator beneath the sample probe and raise the vial upwards so that the sample probe enters into the blood 3 Press the Start key on the front panel to initiate the cycle of the first sample or press the manual sample bar The cycle will begin and the sample will be aspirated tissue to prevent any dried blood from reentering into the calibrator material Dried w Wipe any excess blood from the cap and threads of the calibrator vial with a lint free Blood re entering into the vial may give error flags and reject the sample runs 2 2 6 Calibration Results Validating results Verify that the results are within 20 of each parameter target value Press the Enter key to continue Valid calibration 1 6 message is displayed Press Enter to valid Esc to reject and to return to the first run Start calibration 2 6 message is displayed rejected The system will automatically re set itself to rerun that sample If you acquire 3 rejects continuously on the same number sample abort calibration and contact your local HORIBA Medical Technical Support
81. e 12 Possible defective motor call HORIBA Medical Techni cal support Carriage motor error Possible restriction of movement from the Down posi tion to Up home position check for restriction Needle motor error Possible defective needle sensor Proceed as described in 1 3 7 1 Check sensors test page 12 Possible defective motor call HORIBA Medical Techni cal support Possible Micro switch failure behind Piercing mecha nism check switch contact with applicator stick call HORIBA Medical Technical support for assistance Piercing motor error Restriction of movement to Up piercing position check for restriction Possible defective piercing motor call HORIBA Medi cal Technical support ABX Micros User Manual RABO42IEN 23 ABX Micros GO Tab 6 6 Error message Corrective Action Printer is Off Line reset printer See Section 5 Noprintererror 2 1 Reprint Results page 5 3 Power On and or reconnect printer to unit See Section 5 2 1 Reprint Results page 5 3 Incorrect printer setup See Section 5 2 4 Printer Printer not selected error Selection page 5 5 Use the Period key between each group of numbers when entering the date Bad Date Try again error Possible wrong date format check for the correct date format re enter the date Use the Period key be tween each group of numbers when entering the date Use the Period key between each group of numbers 2 a
82. e control kit 2 Run the Normal Level control 6 times as a regular patient analysis When the cycles are complete note only the RDW results Write down these results for future reference use 3 Calculate the Mean value for all 6 results and write it down for future reference use 4 Take the Control Assay sheet that comes with the control kit and note Only the Normal Control Mean Assay value for RDW Calculate the new RDW coefficient as followed 5 Take the Normal Control Mean Assay value for RDW Divide it by the Mean value of the Normal control ran 6 times as a sample times the current RDW calibration coefficient This will equal the New RDW Calibration coefficient 6 Proceed as described in RDW coefficient editing page 17 to enter this new value ABX Micros User Manual RABOA42IEN 17 ABX Micros GO 7 Now take all 3 levels of controls LOW NORMAL HIGH and run them 1 time each as a regular patient analysis When the cycles are complete note only the RDW results and compare them to the control Assay values for RDW on the Assay sheet Verify that the RDW results are somewhat close to the Mean Assay values and within the ranges as specified for all 3 Levels 8 The RDW calibration is now complete Be sure to monitor your RDW results and verify that they fall within your patient population 9 Verify that Normal RDW results will be within the established ranges set in the setup menu See Section 5 3 Lab
83. ed out nor will it print out the startup status unless startup has failed 5 Date and Time This Setup sub menu will allow the operator to change time see 5 1 Change Time page 15 date format see 5 2 Change the Date Format page 15 and date see 5 3 Change Date page 15 on the instrument to accommodate different time zones and geographical locations when needed 14 RABO42IEN User Manual ABX Micros GO Setup Host Computer Options 5 1 Change Time Changing time Main Menu 5 Setup 4 Date and Time 1 Chg Time Enter the Hours set for 24 hr then press the Decimal key Now enter the Minutes Press the Enter key to save 5 2 Change the Date Format This sub menu will allow the operator to change to format of the date according the Country s specifications Changing date format Main Menu 5 Setup 4 Date and Time 2 Date Format Select one of the 4 formats below 1 Month Day Year MM DD YY 2 Day Month Year DD MM YY 3 Year Month Day YY MM DD 4 Year Day Month YY DD MM Press the Enter key to accept that specific date format 5 3 Change Date This sub menu allows the operator to change the actual date once the correct format has been selected Changing date Main Menu 5 Setup 4 Date and Time 3 Chg Date Enter the first 2 numbers then press the Decimal key Enter the second 2 numbers then press the decimal key again Now enter the last
84. eedle carriage assembly moves to the right over the RBC PLT chamber 2 0ml of Diluent and the 28 of diluted blood is injected into the RBC PLT chamber from the inner sample probe 0 5ml of Diluent is added to the dilution in the chamber from the outer sample probe This makes the total dilution for the RBC PLT WBC RBC HGB a PLT 7 Diluent Lyse Sample Fig 2 1 sample dilution 2 3 CBC Measurement Principles 2 3 1 RBC PLT The RBC s and PLT s are measured by an electronic impedance variation principle This means that an electronic field is generated around the micro aperature in which the blood cells pass through The cells create a resistance in the electronic field as they pass through the Calibrated micro aperture This inturn causes an electronic pulse to be generated which is amplified measured and then mathematically calculated to create a numerical value First the 28 3yL Diluted Blood sample is diluted in an Electrolytic Diluent electronic current conducting fluid mixed then pulled through a calibrated micro aperture There are two electrodes that are placed on each side of the aperture and a constant electronic current passes between them ABX Micros User Manual RABO42IEN 5 ABX Micros GO As the blood cells pass through the aperture they create resistance Impedence in the electronic field between the two electrodes Since the current is constant and remains unchanged the larger
85. el 8 Gently and thoroughly mix the next control level blood Repeat steps 5 through Accepting QC results page 6 9 After accepting the second control level results the ABX Micros GO automatically loads the last control level without returning to the SELECT LEVEL display 10 Gently and thoroughly mix the next control level blood Repeat steps 5 through Accepting QC results page 6 11 Once the last control level has been accepted the display will indicate Storing QC results Valid QC message is displayed Press Enter key QC Stored message is displayed Press the Esc key to exit QC menu If the QC is accepted and validated the index is increased on the QC Smart card and the ABX Micros GO internal index is increased as well 1 2 6 2 Rejecting Results Error flags such as H L and for HGB on control results are NON valid results The parameters with these specific flags should be reviewed and questioned before continuing with the next level of control blood Accepting QC results Results are not within acceptable limits Alarms have been triggered out Press the Esc key Valid Low is displayed Press the Esc key to reject you have the option of re running that same control level again or selecting another level No results will be stored on the QC smart card 6 RABO42IEN User Manual ABX Micros Quality Assurance Quality Control 1 2 6 3 Exiting Q C
86. eliable and must be verified by a Manual Platelet Count 3 If the number of particles between 18fl and 25fl are too high the SCH Schizocytes flag will be triggered Suspected abnormalities include Presence of Schizocytes Presence of Platelet aggregates Verify the Platelet results on a stained blood smear 4 The SCL Small cells flag indicates the presence of small cells in the 2fl to 3fl zone The PLT results may be reported as and there may also be no PLT Histogram 6 3 2 Flags on WBC Distribution curve The ABX Micros GO 05 0116 and 05 0518 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 the excessive presence of Eosinophils and Basophils 1 Flag L1 indicates an abnormal number of cells in comparison with the Lymphocytes in the 30fl to 60fl zone The pathological elements which may be found in this area include Platelet aggregates Red blood cells This flag corresponds to the number of cells counted in the first 5 channels out of the total number of Lymphocytes 2 The M2 flag indicates an excessive number of cells in the 130fl to 160fl zone The Patholog ical elements which may be found in this area will include Lymphoblasts Myelocytes Atypical Lymphocytes Basophilia too many basophils This flag corresponds
87. en selected from the setup menu see Section 3 3 1 Sample identification modes page 3 6 proceed as follows Entering Identification Press the ID key to enter the sample Run Use the Number keys only Enter a run number from 1 to 99999 Press the Enter key to save the current Run Or press the Esc key to display the previous Run 6 RABO42IEN User Manual ABX Micros GO Workflow Sample selection and identification Once the Identification has been entered a message will appear on the LCD display stating Press the sampling bar press the manual sampling bar or press the Startup key on the front panel of the ABX Micros GO to start the analysis cycle ABX Micros User Manual RABO42IEN 7 ABX Micros GO 4 Running Samples 4 1 Preliminaries 1 Run the Quality Control blood all 3 levels and verify that the results are within their specified limits see Section 4 1 Quality Control page 4 2 2 Mix the blood sample gently and thoroughly 4 2 US mode Running analysis Press the ID key and enter the patient Identification See 3 1 1 US Mode page 6 Remove the cap from the sample tube Place the sample beneath the sample probe raise the sample tube upwards so that the sample probe enters into the blood Press the manual sample bar and analysis will begin Press the Startup key on the front panel if the system does not respond to the Manual sample bar 4
88. ene nnne nnne 1 8 3 25 PRECISION rua c 1 9 3 3 Precision Repeatability essen eene eene nnne nnn een 1 10 3 4 1 10 3 5 CANY o MERE ecavsaesuse neues Seduvensanduidstuntadedaumeuesetuavadssnecseawsdedenetaaueads 1 11 3 6 Normal Ranges 22 m 1 11 LEE era 1 12 3 8 Leucocytes Differential count 1 12 3 9 Sample stability Study reo roe Seen o te ente ean se Seed pu On ne wee aie ndn 1 12 4 Limitations B 1 13 4 1 MAINTENANCE 1 13 4 2 Blood SPECIMENS NV e Ue 1 13 4 2 1 Sample collection and mixing 1 13 4 2 2 Sample Stability gee ee 1 13 4 2 3 Anti coagulants and their effects on whole blood 1 14 4 3 Known Interfering Substances ccccsssecccesceccseeeceeeeeceeeececeneceeeeeeeeeueess 1 14 4 3 1 HET tente xe go ee ener eek aou 1 14 4 3 2 RBC Red Blood Cells Erythrocytes 1 14 4 3 3 WBC White Blood Cells Leukocytes 1 15 4 3 4 HGB Hemoglobin 1 16 4 3 5 MCV Mean Corpuscular Volume 1 16 4 3 6 Mean Corpuscular Hemoglobin
89. entioned above this clinical study was performed at 3 different sites throughout the United States 3 8 Leucocytes Differential count Not available at the time of publication 3 9 Sample stability study Not available at the time of publication 12 RABO42IEN User Manual ABX Micros GO Specifications 4 Limitations interference s it is by no means possible to guarantee that all interference s have been identified At all times results should be validated and communicated only once all information relating to the patient has been assessed and taken into account Whilst every effort is taken by HORIBA Medical to investigate and indicate all known 4 1 Maintenance In this Manual specific Start up Shutdown and Maintenance procedures are listed The Maintenance procedures listed in this manual are mandatory for the proper use and operation of the ABX Micros 60 Failure to execute any of these maintenance procedures may result in Decreased Reliability of the system High emphasis on maintaining the system is strongly suggested 4 2 Blood Specimens All Blood samples should be collected using proper technique Consider all Specimens Reagents Calibrators Controls etc that contain Human blood ML or serum as potentially infectious Use established good laboratory working practices when handling specimens Wear pro tective gear gloves lab coats safety glasses or face shields and follow other biosafety pr
90. erator 4 The Sequence number of the sample run 5 The PLT flags if any were reported 6 The 8 Parameter CBC results with Limit flags and units increases by increments of 1 each analysis cycle sequentially this sequential number The sequence number is updated the number 1 each calendar day the number 4 can not be modified by the operator 12 RABO42IEN User Manual ABX Micros GO Workflow Results 5 2 ABX Micros GO OS OT16 5 2 1 Displayed Results The first group of Parameter results are as displayed on the LCD screen once the analysis cycle is complete The second group of parameter results can be displayed as follows Parameter results review RESULTS menu Up or Down Arrow keys 5 2 2 Identification The sample identification can be reviewed on the LCD screen 5 2 2 1 US Mode Sample identification review RESULTS menu Up or Down Arrow keys 5 2 2 2 Standard Mode Runit identification review RESULTS menu Up or Down Arrow keys 5 2 3 Flags The PLT and WBC flags can be reviewed on the LCD screen PLT and WBC flags review RESULTS menu Up or Down Arrow keys ABX Micros User Manual RABO42IEN 13 ABX Micros GO 5 2 4 Result printout US mode example RESULTS DATE 01 20 2002 09 25 ID SMITH 1234567 SEQ 27 STARTUP PASSED PLT Flags WBC 7 5 103 mm 3 5 10 0 MCV 90 um 80
91. es linked to Anisocytosis The RDW will enable you to follow the evolution of the width of the RBC Histogram in relation to the number of cells and their average volume This is also a calculation of the RBC Histogram Calculations are as followed RDW 90 K SD MCV Calibration Coefficient for RDW 5 eese Standard Deviation according to statistical studies on cell distribution MCV Mean Cell Volume of the erythrocytes 2 3 6 MPV The MPV Mean Platelet Volume is directly calculated from the Platelet histogram distribution curve This calculation is almost the same as the MCV 2 3 7 PCT Thrombocrit Plateletcrit is calculated according to the formula PCT PLT 102 mm x MPV um 10 000 8 RABO42IEN User Manual ABX Micros GO Description amp Technology Technology 2 3 8 PDW The PDW Platelet Distribution Width is calculated from the Platelet Histogram Distribution curve The PDW is represented by the width of the curve between 15 of the number of platelets starting from the Low Threshold 2fl S1 and 15 of the number of platelets begining with the Variable High Threshold S2 The PDW determination area is shown by the distribution curve below Fig 2 6 Platelet distribution curve PCT and PDW are not available in the United States These parameters are strictly used for research and investigational purposes Only 2 3 9 WBC The WBC Measurement principles are based u
92. estion cycles will be performed If all 3 startup cycles fail the HGB blanck test an error w If the HGB blank test is unacceptable during the first Startup cycle 2 more startup message will be printed out stating startup failed HGB reference failed If any analysis cycles are run prior to a Startup cycle a message will be displayed on the LCD and printed out stating Startup cycle not initiated When the ABX Micros has not been used within 4 hours of the last cycle it is necessary to perform a STARTUP cycle before running an analysis cycle ABX Micros User Manual RABO42IEN 3 ABX Micros GO 1 4 Blood Sample Collection Refer to Section 1 4 2 Blood Specimens page 1 13 for collection requirements Blood samples must be gently and thoroughly mixed with a rocking or tilting motion just before placing the sample into the tube holder for the analysis cycle 4 RABO42IEN User Manual ABX Micros GO Workflow Daily Quality Control amp Calibration verification 2 Daily Quality Control amp Calibration verification Before analyzing any patient blood samples it is recommended that the Operator performs Quality Control analysis on 3 levels of Control Blood Material Low Normal and High to verify that the ABX Micros GO is performing within the specified ranges of the Quality control material Please refer to Section 4 1 Quality Control page 4 2 in order to perform the Control sample run
93. et Flags o eer nene ye eene o spen 5 9 3 4 2 WBC flags eres SUR MRRERKR 5 9 4 Special Functions ssscsecciscesssssedessscsessssccssssccsssccesesteseasdedassssecaeccescesesseevesssecess 5 10 4 1 Changing Operator aaa aue US 5 10 4 2 Changing the User Password 5 10 4 3 Choosing Startup Cycle eee ne eek 5 11 4 4 Setting Autocleaning frequency 5 11 4 5 Printing Instrument Configuration 5 12 4 6 Setting buzzer cycle end tee eee eee ete eee sua rd be sue eoo vado a 5 14 4 7 Choosing sample identification mode 5 14 5 Date Time R 5 14 5 1 CHANGE TIME iu eoe oec enun E peaux eere Yr Ya nem e Ern Ex Eee eee RE n e rer ees Exe 5 15 5 2 Change the Date Format 5 15 5 3 Change Date 5 15 6 Host Computer Options eee e ee eee eee eee eee nenne ne eee eene ette ee ette ee sone e esso 5 15 0 1 Host Commiuticatiolis eoe lode eee ye ee uere ee ne pex esa 5 16 6 2 Mtt 5 16 6 3 TKANSIMISSION exe ee sees veuve eee epe tesa eu eed eeu e ross eg 5 16 7 Barcode Setup RR
94. etc When only one parameter is affected it is necessary to look for a cause in this specific area of anal ysis The different tables listed give the noted problems for the parameter in question possible cause of the problem and the necessary user action to correct the problem 18 RABO42IEN User Manual ABX Micros GO Maintenance amp Troubleshooting 2 3 1 Problems on all Parameters Tab 6 2 Troubleshooting Problem Noted Possible Cause Corrective Action Startup Failed No results in analysis Suspicious patient results Alarm flags on most parameters QC outside acceptable limits Poor repeatability Poor Chamber drainage Out of Reagent s Contaminated Reagent s Possible dirty Apertures Blocked sample probe Possible defective Pre amp on Main Board Possible dirty Apertures Check and or replace reagent s if necessary Check and or replace reagent s if necessary Perform a concentrated cleaning 1 3 6 Concentrated Cleaning page 11 re run startup Remove and flush out sample probe as descibed in Section 6 1 7 Manual Probe Cleaning page 6 13 Call HORIBA Medical technical support for Assistance Perform a Concentrated cleaning 1 3 6 Concentrated Cleaning page 11 re run sample Possible partial blocked sample probe Remove and flush out sample probe Possible leakage from syringe blocks Possible Fibrin clot in T fitting be low WBC chamber Possible dir
95. eter The results can be reported but the parameter should be monitored for the next sample analyzed 6 2 4 HGB Blank Reference A suspicious flag shown by an Exclamation located next to the Hemoglobin result shows that the HGB Blank carried out during the analysis differs from the previous cycle s HGB Blank This means that both HGB blanks were outside the Instrument precision limits This result can be reported but the parameter should be monitored for the next sample analyzed The MCH and MCHC may also be affected by this flag depending on the severity of the results the HGB parameter in the following section of this manual Section 6 If the Exclamation flag occurs more than 3 consecutive sample runs troubleshoot 2 Troubleshooting page 6 17 16 RABO42IEN User Manual ABX Micros GO Workflow Flags 6 3 Morphology Flags 6 3 1 Flags on PLT Distribution curve The PLT Histogram has 128 channels between 2fl and 30fl A mobile Threshold Positioned to 25fl by default moves according to the Microcyte population present in the Platelet analysis area The PLT flags are as followed 1 An excessive presences of cells to the right of the Threshold area 258 will trigger the MIC Microcytes flag The Mobile threshold looks for a valley between the 25fl standard value and 18fl 2 When there is No valley between PLT and RBC populations a reject PLT flag is triggered PLT results are not r
96. event Reagent pollution or oxidation Menu access Main Menu 4 Service 3 Prime then select the reagent or reagents that need to be primed 1 All Reagents 2 Diluent 3 Lyse 4 Cleaner 1 1 2 Minipack Units All Reagents and a Waste bladder are contained in one Minipack When a Reagent Pack runs low the instrument will display a message stating that the reagent pack is low This warning message is given according to the numbers of CBC cycles left in the pack To replace the Pack follow the steps through the menus Menu access Main Menu 4 Service 3 Prime 3 Prime 2 Pack unit 1 Change Pack The ABX Micros GO will show the remaining steps to follow on the LCD display Once this Pack replacement is complete the instrument automatically resets the CBC cycle counter to 160 cycles 2 RABO42IEN User Manual ABX Micros GO Workflow Startup checks 1 2 Printer Power and On line Checks Prior to instrument startup always check the printer to verify that the power is turned ON and that the LED s are in the ready state Check that the printer has sufficient paper for the daily operations Check the alignment of the paper if your printer is a tractor feed printer 1 3 Instrument Startup Power ON the instrument by pressing the ON OFF switch located on the back lower center of the rear panel The LCD display will show the following Screen display Please wait for 3 Min This indicates an instrument
97. f the daily means and the Total Imprecision with the NCCLS EP 5 Guidelines Tab 1 5 Pees na E Control Means Means sion SD M243 High 0 23 0 20 0 19 0 29 WBC M243 Normal 0 10 0 08 0 11 0 14 M243 Low 0 06 0 03 0 04 0 06 M243 High 0 05 0 04 0 04 0 06 RBC M243 Normal 0 05 0 04 0 04 0 06 M243 Low 0 04 0 03 0 03 0 04 M243 High 0 31 0 23 0 40 0 49 HGB M243 Normal 0 12 0 16 0 43 0 45 M243 Low 0 09 0 22 0 29 0 33 M243 High 0 52 0 79 0 96 1 17 HCT M243 Normal 0 56 0 51 0 74 0 91 M243 Low 0 26 0 26 0 32 0 42 M243 High 13 71 6 49 9 07 14 04 PLT M243 Normal 9 17 7 23 5 87 10 13 M243 Low 5 83 3 78 3 69 4 97 8 RABO42IEN User Manual ABX Micros GO Specifications Summary of Performance Data Tab 1 6 Control A means means sion CV M243 High 1 19 1 01 0 96 1 46 WBC M243 Normal 1 39 1 11 1 46 1 93 M243 Low 3 06 1 68 1 93 3 13 M243 High 0 9 0 62 0 78 11 RBC M243 Normal 1 02 0 88 0 8 1 24 M243 Low 1 46 1 07 1 15 1 72 M243 High 1 72 1 28 2 23 2 7 HGB M243 Normal 0 85 1 17 3 17 3 33 M243 Low 1 49 3 5 4 65 5 37 M243 High 1 06 1 62 1 96 2 39 HCT M243 Normal 1 51 1 38 2 2 47 M243 Low 1 6 1 6 1 96 2 53 M243 High 2 89 1 37 1 91 2 96 PLT M243 Normal 9 17 7 23 5 87 10 13 M243 Low 5 14 6 87 6 70 9 04 Evaluation of Precision Performance of Clinical Chemistry Devices Approved Guidelines NCCLS document EP 5 ISBN 1 56238 145 8 1999 Source 510K submission K030799 3 2 Precision Claims Tab 1 7 WBC 2 59 10 0 x 10 u
98. fections Idiopathic disease Aneurism Pregnancy Thromboembolic phenomena Diabetes etc which can elevate the WBC RBC and PLT counts along with the HGB value The specimen can be warmed up to 37 C and re analyzed immediately If warming the specimen has no effect on the count a Manual WBC RBC and or PLT count can be performed Increased Turbidity may also be seen in cases where the red blood cells are resistant to the lysing action This condition will cause a falsely elevated Hemoglobin result but may be detected by observing the abnormal MCH and MCHC values also the increased baseline on the Left leading edge of the WBC histogram Erroneous Hemoglobin results will also cause the results of the MCH and MCHC to be erroneous as well ABX Micros User Manual RABOA42IEN 15 ABX Micros GO 4 3 4 HGB Hemoglobin Turbidity of the Blood sample Any number of physiologic and or theraputic factors may produce falsely elevated Hemoglobin results To obtain accurate HGB results when increased turbidity of the blood sample occurs determine the cause of the turbidity and follow the appropriate Method below 1 Elevated WBC An extremely elevated WBC will cause excessive light scatter from the L E D In these cases use Reference Manual methods The Diluted sample should be Centrifuged and the Supernatant fluid measured with a Spectrophotometer 2 Elevated Lipids Elevated Lipids in the blood will give the plasma a mi
99. ftware Note The ABX Micros GO performs automated blood counts and requires no manual operations for aspirating blood dilutions measuring calculations print outs and computer transfer of data The parameters are given according to the Internal Setup 1 1 Parameters Tab 1 1 ABX Micros GO 5 parameters 5 parameters White Blood Cells Red Blood Cells Hemoglobin Hematocrit Mean Platelet Volume RBC Distribution Curve Tab 1 2 ABX Micros GO 8 parameters 8 parameters MCHC PLT White blood cells Red blood cells Hemoglobin Hematocrit Mean Corpuscular Volume Mean Corpuscular Hemoglobin Mean Corpuscular Hemoglobin Concentration Platelets RBC and PLT Distribution Curves Tab 1 3 ABX Micros 16 parameters 16 parameters WBC LYM LYM MON MON GRA GRA White blood cells Lymphocyte Percentage Lymphocyte Absolute number Monocyte Percentage Monocyte Absolute number Granulocyte Percentage Granulocyte Absolute number ABX Micros User Manual RABO42IEN 3 ABX Micros GO Tab 1 3 ABX Micros GO 16 parameters 16 parameters RBC Red blood cells HGB Hemoglobin HCT Hematocrit MCV Mean Corpuscular Volume MCH Mean Corpuscular Hemoglobin MCHC Mean Corpuscular Hemoglobin Concentration RDW Red cell Distribution Width PLT Platelets MPV Mean Platelet Volume WBC RBC and PLT Distribution Curves Tab 1 4 ABX Micros GO 18 parameters 18 Parameters WBC White
100. g page 11 re run startup Remove and flush out sample probe Section 6 1 7 Manual Probe Cleaning page 6 13 Re run startup Check syringe block for leakage and call HORIBA Med ical Technical support Startup Failed Possible electronic interferences Call HORIBA Medical Technical support for assistance Check and or replace reagent s Perform a concentrated cleaning 1 3 6 Concentrated Startup Failed HGB reference failed Cleaning page 11 re run startup Possible bad HGB blank reference voltage Call HORIBA Medical Technical support for assistance For Pack units remove Waste line from pack push down Pressure syringe motor error Pack units on and hold in pack waste valve push on side of pack to force air out of waste badder Reconnect waste line Check for obstruction or restriction of Waste line Waste container must be vented Possible defective motor Call HORIBA Medical Techni cal support for assistance Pressure syringe motor error separate reagent units Check syringe block moving smoothly call HORIBA Medical Technical support Possible disconnected cable from main board remove unit cover check all connectors Possible defective motor call HORIBA Medical Techni cal support Liquid syringe motor error Possible restriction of movement from the chambers to home position check for restriction Possible defective carriage sensor Proceed as described in 1 3 7 1 Check sensors test pag
101. his allows the operator to check syringe block that moves Sample Di luent and Lyse into the chambers 5 Pressure Syringe This allows the operator to check the Vacuum Waste syringe for com plete movement up and down 6 Valves This allows the operator to operate all valves on the analyzer in a sequencial order from 1 to 13 7 Chg Contrast This allows the operator to change the contrast of the LCD display 8 Park This allows the operator to place the Vacuum Waste syringe in a position suitable for long term storage of the analyzer 1 3 7 1 Check sensors test 1 Once you have accessed to the Check Sensors Menu as described in 1 3 7 Mechanical Checks page 11 press the Enter key The display will indicate Needle Sensor 0 Carriage Sensor 0 Needle Sensor Open The Main Door and move the sample needle upwards by the top support brack et If the sensor is good it turns from 0 to 1 followed by 10 stars Carriage Sensor With the sample needle in the Up position move the sample carriage towards the right If the sensor is good it turns from 0 to 1 followed by 10 stars as indicated below Needle Sensor 1 Carriage Sensor 1 y 2 Press any key to exit the function If any of these sensors remain at 0 when the mechanism has been moved call your local HORIBA Medical Technical Support Representative for assistance with this issue 1 3 7 2 LCD Contrast Adjustment The LCD Contras
102. ime 10 RABO42IEN User Manual ABX Micros GO Maintenance amp Troubleshooting Maintenance When priming reagents or pack verify that Reagent is being primed View the Chambers for reagent priming Verfiy that reagent is coming in and draining out of the chambers when a cycle is initiated Verify that there are No Air Bubbles in the reagent lines when priming 1 3 6 Concentrated Cleaning This service function allows the operator to perform a very strong cleaning of the WBC and RBC counting chambers and apertures This service function is used when frequent parameter and or morphology flags are present on nor mal patient results 1 Prepair the following solutions Minoclair or bleach containing 1295 active chlorine Running concentrated cleaning Main menu 4 Service 4 Concentrated Cleaning Press the Enter key and follow the steps that appear on screen 2 Follow the steps that appear on the displays indicated 3 Open the main cover door of the instrument as described in 1 3 2 Cover dismantling page 8 Pour 3ml of cleaner in the WBC chamber press a key to continue 4 Dispense the bleach solution you choose into the WBC chamber or into the hole on the top of the cover so that it goes into the chamber Pour 3ml of cleaner in the RBC chamber press a key to continue 5 Dispense the bleach solution you have chosen into the RBC chamber or into the hole on the top of the cover so that it goes into
103. in Menu then press the Startup key to initiate the Startup cycle This will prevent the STARTUP CYCLE NOT INITIATED message from appearing on the printout of any analysis cycle run prior to instrument Startup If the message STARTUP CYCLE INITIATED appears on the display after selecting ABX Micros User Manual RABO42IEN 11 ABX Micros GO Setting Autocleaning frequency Main Menu 5 Setup 3 Special Press the Enter key Enter system default Password 123 or the one defined by the operator Press the Enter key 4 Clean freq Enter the number of the analysis cycles to be run before cleaning Press the Enter key to save or press the Esc key to abort 4 5 Printing Instrument Configuration This sub menu allows the operator to print out the internal Instrument settings from all the menus which allow user intervention Printing Instrument Configuration Main Menu 5 Setup 3 Special Press the Enter key Enter system default Password 123 or the one defined by the operator Press the Enter key 5 Print Config Press the Enter key to run the printout of the internal setup The following information will be printed out as noted 12 RABO42IEN User Manual ABX Micros GO Setup Special Functions Date and Time of print request Laboratory Limits and Flag values Instrument Configuration heading Last operator to use Quality Control L
104. ing chambers Main menu 4 Service 2 Drain chambers Press the Enter key Verify the proper draining of the waste through the waste tubing located on the back of the instru ment if it is not flushing waste sufficiently check the waste tubing connection and verify that there is no blockage or crimping of the tubing Verify that both the WBC and RBC chambers are draining properly not slow but fairly rapid If not view the troubleshooting Section 6 2 Troubleshooting page 6 17 1 3 5 Prime Reagents This service function will allow the operator to prime reagents either individually or all at once de pending on the type of system you have Separate Reagents or Minipack 1 3 5 1 Bottle unit Priming reagents Main menu 4 Service 3 Prime 1 Bottle Unit Select 1 All Reagents or 2 3 4 according to reagent to prime Press the Enter key to start the priming 1 3 5 2 Pack unit If the current Minipack is low proceed as described in 1 2 3 Reagent pack connection page 5 to replace the Minipack and perform the following step by step instructions will be given on the dis play when installing a Minipack Replacing Pack Main menu 4 Service 3 Prime 2 Pack unit 1 Change Pack Press the Enter key to start priming Select 2 Capacity to display the analyses left with the current pack The 2 Pack Unit menu provides two more functions 4 Select 3 Prime Reagents to run a priming cycle at any t
105. intenance 6 2 1 1 Daily cm 6 2 1 1 1 Startup and Standby Cycles eene enne 6 2 1 1 2 Automatic CLEANING s eee eoe retinere eno eee enne repe ve eee E stages 6 2 1 1 3 General Cleaning of the Instrument 6 3 1 2 Reagent connections tr 6 4 1 2 1 Bottle connections cresien enne nnne nennen een 6 4 1 2 2 Alphalyse 360 scusa basis ersetinpu vete nndano RO oamb te had gentes 6 4 1 2 3 Reagent pack 6 5 1 2 4 Diluent 8 Waste connection 6 7 1 2 5 Reagent priming eeeessseeeeeeee eee eene nennen nnne nennen enter sense 6 7 1 3 Service FUnctlorns ossis Yn eoe Yn Eon a eoe aeo Ya 6 8 1 3 1 Menu Service overview enne nennen nnne 6 8 1 3 2 EDT TRETEN RET 6 8 1 38 EE 6 9 1 3 4 Drain Chambers 6 10 1 3 5 Prime Reagents nienie TAE 6 10 1 3 6 Concentrated Cleaning 6 11 1 3 7 Mechanical CHECKS 1 rere 6 11 1 4 Instrument M t 6 13 1 5 Technician Functions
106. ions Portable mobile telephones should not be used in proximity of the instrument peripheral devices should comply with relevant standards 2 1 Limited guarantee The duration of guarantee is stipulated in the sales conditions associated with the purchase of this instrument To validate the guarantee ensure the following is adhered to 1 The system is operated under the instructions of this manual 2 Only software or hardware specified by HORIBA Medical is installed on the instrument This soft ware must be the original copyrighted version 3 Services and repairs are provided by a HORIBA Medical authorized technician using only HORIBA Medical approved spare parts 4 The electrical supply of the laboratory adheres to national or international regulations 5 Specimens are collected and stored in normal conditions 6 Reagents used are those specified in this user manual 7 Proper tools are used when maintenance or troubleshooting operations are performed If this instrument has been supplied to you by anyone other than HORIBA w Medical or an authorised representative HORIBA Medical cannot guarantee this product in terms of specification latest revision and latest documentation Further information may be obtained from your authorised representative 6 RABO42IEN User Manual ABX Micros Introduction Working conditions 2 2 Safety Precautions Electronic and moving parts The following parts mus
107. ions Heparin Causes an increase in cell clumping WBC s and PLT s and modifies cytoplasmic color with Romanowsky staining Blue background An increase in HCT and MCV with high heparin concentrations gt 7 5UL capillary tube Trisodium Citrate Because the anti coagulant is liquid it includes a dilution estimated at 10 11 when filling 5ml tubes with whole blood This anti coagulant is used in coagulation It is sometimes used in hematology when an EDTA induced Pseudothrombocytopenia is suspected Acid Citrate Dextrose ACD and Citrate Phosphate Dextrose with Adenine CPDA The most commonly used anti coagulants for cell concentrates in particular Platelet concentrates is normally not used for cell counting There is no seriously known interference characteristics of the blood components Caution is advised when selecting an anti w Anti Coagulants used in blood collection may vary in the effects of changing the coagulant for analysis on the ABX Micros 60 EDTA Amoung the EDTA salts EDTA K USA and Japan EDTA USA and Europe and sometimes NA EDTA are used EDTA and EDTA are the most frequently used anti coagulants for Hematology testing Worldwide Mainly because they have been recommended by ICSH since 1993 The other EDTA salts are acceptable as well EDTA can include Pseudothrombocytopenia estimated frequency 1 800 through Platelet clumping Fluoride Was used before EDTA replaced it No side affects as k
108. lculated from the comparison study Press Enter key to accept the new value Return to Main menu pressing the Esc key The RDW calibration is normally performed by taking blood samples from 100 healthy normal and drugfree individuals These blood samples are then analyzed on instrument that has been calibrated for RDW determination The Mean and Standard Deviation are then calculated from that population analyzed The same 100 samples are then analyzed on the ABX Micros GO A population Mean is calculated and then compared to the known calculated Mean from the comparison instrument The RDW calibration coefficient for the ABX Micros GO is then calculated from the difference of the two Mean values Expected RDW values may vary with sample population and or geographical location it is highly recommended that each laboratory establish its own normal ranges based on the local population 2 2 11 RDW calibration using a Quality Control Standard The RDW may also be calibrated by using a known Quality Control Standard DEFINITION A Quality Control Standard is defined as a Commercial blood product which has been specifically developed and Assayed with set parameter Target values and ranges This product is designed to precisely measure the accuracy and linearity of the analyzer 1 Take the controls and bring them to room temperature Gently and thoroughly mix the control material as indicated on the instruction sheet that comes with th
109. ld up on the counting chambers and apertures This Standby cycle is a very The Standby mode introduces MINICLEAN into the chambers for the enzymatic cleaning important step in daily maintenance 1 1 2 Automatic Cleaning This Automatic cleaning cycle is automatically performed when the number of analysis cycles has been reached to initiate the auto clean cycle This cleaning frequency cycle can be programmed by the operator according to the workload of the Laboratory See Section 5 4 4 Setting Autocleaning frequency page 5 11 Running an automatic cleaning Main menu 4 Service 8 Auto clean Press the Enter key 2 RABO42IEN User Manual ABX Micros GO Maintenance amp Troubleshooting Maintenance 1 1 3 General Cleaning of the Instrument 1 1 3 1 External cleaning The external surfaces of the instrument must be decontaminated considering the biological environment Never spill liquids the instrument A Never use disinfectant product that contains alcohol Never use solvants or abrasive materials Wipe off any trace of blood spillage as soon as possible Always disconnect the main electrical supply before cleaning the exterior of the an alyzer Make sure that the instrument is completely dry before re connecting the elec trical power Y All contaminated surfaces Slightly wet a sponge with disinfectant product and wipe the dirty surfaces Y Stainless steel Slightly wet a sponge with
110. le in 5 8 16 and 18 parameters These parameters noted according to the system setup See Section 1 1 1 Parameters page 1 3 The Rate of determination is approximately 60 samples per hour in the optimum configuration The system is totally automated including an internal dilution system and a Graphic printer for recording all test results including flags and graphics 7 Presentation The ABX Micros GO which is small in size has 8 main parts 1 The Electrical supply 2 The Electronic Main board 3 The Dilution Pneumatics 4 The Control panel including a key pad and LCD screen 5 A Reagent compartment ABX Micros User Manual RABO42IEN 13 ABX Micros 60 6 A Printer that prints out results and Distribution curves 7 A Smart Card Reader optional for Quality Control result records and Patient result records 8 A Barcode reader optional for a direct entry of the Alphanumerical identifications ABX Micros Models Available This instrument is available in the following different models TheABX Micros GO OT This model is an Open Tube unit Without a Smart Card reader The operator must remove the cap from the blood collection tube before analyzing any sample The ABX Micros 60 05 This model 15 an Open Tube unit With a Smart Card reader The Smart Card reader gives the operator the ability to record results and perform automated Quality Control The operator must remove
111. libration again or call your local HORIBA Medical Technical Support representative for further instructions Failed Calibration printout is as follows CALIBRATION TIME 09 48 DATE 01 20 2006 OPERATOR ABC LOT MCAL212 RUN WBC RBC HGB 1P 10 2 4 50 14 0 2 9 9 4 45 14 0 3 9 7 4 41 14 0 4 10 0 4 51 14 2 5 9 9 3 65 14 1 6 9 8 4 38 14 1 MEAN 9 9 4 32 14 1 TARGET 9 9 4 54 13 5 CV 1 0 7 7 07 CHG 0 0 5 09 5 74 REJ COEFF 1 09 0 89 1 11 CURRENT 1 09 1 05 1 07 STATUS OK FAILED OK HCT PLT 38 0 242 37 4 246 37 2 237 37 9 251 31 8 254 36 8 248 36 5 247 37 2 260 6 3 2 3 1 92 5 26 1 08 1 20 1 02 1 26 FAILED OK MPV 7 6 7 9 7 7 7 7 7 5 7 5 7 7 7 7 1 8 0 0 0 94 0 94 OK Fig 4 5 Failed Calibration printout 16 RABO42IEN User Manual ABX Micros GO Quality Assurance Calibration 2 2 10 RDW Calibration The RDW calibration is a separate calibration outside the Auto calibration menu The RDW calibration coefficient default value is normally set at 1 00 RDW coefficient editing Main Menu 3 Calibration 2 Coefficients 1 Calib Coeff password 123 or the one defined by the operator in the setup menu See Section 5 4 2 Changing the User Password page 5 10 Press Enter key Select the 7 key or use the Down arrow key to select the RDW coefficient Press Enter key to edit the coefficient Enter the RDW coefficient value which has been ca
112. lky appearance This condition can occur with Hyperlipidemia Hyperproteinemia as in gammapathies and Hyperbiliru binemia Accurate Hemoglobin measurement can be achieved by using reference Manual methods and a plasma blank Increase in Turbidity may also be seen in cases where the Red blood cells are resistant to the Lysing action This condition will cause a falsely elevated HGB result but may be detected by observing the abnormal MCH and MCHC values and the increased baseline on the Left leading edge of the WBC Histogram Erroneous HGB results will cause the results of the MCH and MCHC to be erroneous as well Fetal Bloods The mixing of fetal and maternal bloods may produce a Falsely elevated Hemoglobin value 4 3 5 MCV Mean Corpuscular Volume Red Blood cell Agglutination May produce an erroneous MCV value Red blood cell agglutination may be detected by observing abnormal MCH and MCHC values as well as examination of a stained blood smear In such cases Manual methods may be required to obtain an accurate MCV value Excessive Numbers of Large Platelets and or the presence of an excessively High WBC count may interfere with the accurate determination of the MCV value Careful examination of a stained blood smear may reveal the error 4 3 6 MCH Mean Corpuscular Hemoglobin The MCH is determined according to the HGB value and the RBC count The Limitations listed for HGB and RBC will have an effect on the MCH and may
113. motor steps 4 operator ID s Fig 5 2 internal setup printout ABX Micros User Manual RABO42IEN 13 ABX Micros GO 4 6 Setting buzzer cycle end This sub menu allows the operator to set an audible tone Beep when the analysis cycle is complete Setting buzzer Main Menu 5 Setup 3 Special Press the Enter key Enter system default Password 123 or the one defined by the operator Press the Enter key 6 Buzzer yes no 4 7 Choosing sample identification mode This sub menu will allow the operator to select as to how they want to identify their blood samples 2 options are available in this submenu 1 US Mode allows the operator to type in up to 13 Alphanumeric characters for a blood sample identification See Section 3 3 1 Sample identification modes page 3 6 for details 2 Standard Mode allows the operator to enter numbers Only from 1 to 99999 See Section 3 3 1 Sample identification modes page 3 6 for details Choosing sample identification 5 Setup 3 Special Press the Enter key Enter system default Password 123 or the one defined by the operator Press the Enter key 7 ID mode Select a mode of sample identification Press the Enter key to accept the mode Startup results will be printed out in the US Mode Only If STANDARD Mode is select for sample identification the startup results will not be print
114. n be selected individually or all at once It is highly recommended to print out all Quality Control Statistical data at the end of W each month for hard copy verification of control data Each File printout contains the following information File Name Blood Level Lot of the Control Expiration date of the control Date and Time of the print data request Date and Time of each control run Operator and Parameter results of each control run the Reference Assay Mean Upper and Lower limits the Actual Mean results of the total control runs the Standard Deviation value and the Percent Coefficient of Variation Tab 4 1 Limits of CV on Control blood WBC 790 5 4 RBC 490 3 3 HGB 5 4 3 HCT 5 4 5 4 MCV 490 3 2 5 RDW 5 5 5 PLT 15 10 7 LYM 8 8 8 9 15 14 11 12 4 3 CV are relevant when they are calculated on at least 6 values Printing Statistics Selecting Statistics Main Menu 2 QC 4 Statistics Press Enter key Use the Up amp Down arrow key to select one of the 3 levels to be printed out Or select ALL to print out the 3 levels a star shows the current selection Press Enter key to print out the statistical data 8 RABO42IEN User Manual ABX Micros GO Quality Assurance Quality Control Maintain a copy of these results each month for Quality Control Analysis verification Q C NORMAL LOTH M211 TIME 07 31 EXP DATE 02 20 06 DATE 03 19 06 N
115. n the Assay sheet If all parameters are within their specified ranges Calibration is complete 4 Run Quality Control and verify that all 3 levels of control results are within their specified ranges Verify that all control parameter results are without Flags H L and for HGB 14 RABO42IEN User Manual ABX Micros GO Quality Assurance Calibration 2 2 8 Calibration Passed In order for ABX Micros GO to Pass Calibration the data must meet the statistical criteria which contain 2 conditions 1 The Coefficient of Variations must be within their limits as indicated Tab 4 2 Coefficient of variation limits page 15 2 The difference between the Target value and the Mean for each parameter calibrated must be less than 2090 Tab 4 2 Coefficient of variation limits Ee A SH lt 2 0 lt 2 0 lt 5 0 lt 3 0 CV 2 5 Passed calibration is as follows CALIBRATION DATE 01 20 2006 TIME 09 48 OPERATOR ABC LOT MCAL212 RUN WBC RBC HGB HCT PLT MPV 1P 10 2 4 50 14 0 38 0 242 7 6 2 9 9 4 45 14 0 37 4 246 7 9 3 9 7 4 41 14 0 37 2 237 7 7 4 10 0 4 51 14 2 37 9 251 7 7 5 9 9 4 43 14 1 37 2 254 7 5 6 9 8 4 38 14 1 36 8 248 7 5 MEAN 9 9 4 44 14 1 37 3 247 7 7 TARGET 9 9 4 54 13 5 37 2 260 7 7 CV 1 0 1 0 0 7 1 0 2 3 1 8 CHG 0 0 2 25 5 74 0 73 5 26 0 0 OLD CAL 1 09 0 89 1 11 1 08 1 20 0 94 CURRENT 1 09 0 91 1 07 1 08 1 26 0 94 STATUS OK OK OK OK OK OK
116. ncluded File Name Blood Level Lot of the Control Expiration date of the control Date and Time of the print data request the Parameter Name and the Parameter graph with 40 total data points Below each graph the Reference Assay Mean Upper and Lower limits the Actual Mean results of the total control runs the Standard Deviation value and the Percent Coefficient of Variation ac NORMAL LOT M211 TIME 10 07 EXP DATE 02 20 06 DATE 01 20 06 WBC 5 10 15 20 25 30 35 40 REFERENCE MEAN 7 4 LOW 6 8 HIGH 8 0 ACTUAL MEAN 7 4 50 013 1 70 5 10 15 20 25 30 35 40 i 4 52 LOW 4 34 HIGH 4 70 ACTUAL MEAN 4 54 SD 0 06 1 37 ETC Fig 4 3 QC Graphs printout 10 RABO42IEN User Manual ABX Micros GO Quality Assurance Calibration 2 Calibration 2 1 General recommendations The calibration on HORIBA Medical instruments is an exceptional procedure which must be carried out particularly in case of certain technical interventions installation maintenance service intervention The calibration should not be carried out to compensate a drift on a result due for example to a clogging of the instrument 2 1 1 Preliminaries Before carrying out a calibration it is essential to make sure that the instrument is in perfect condition of operation and to follow the following steps 1 Carry out a Concentrated cleaning procedure
117. ne and releases the Hemoglobin within the RBC The Hemoglobin then combines with the potassium cyanide to form chromogenous cyanmethemoglobin compound This chemical compound is measured by Spectrophotometry through the optical pathway in the WBC chamber The light wavelength of measurement is at 550nm Results The Hgb results are given as such HGB Log blank value Sample value x the Calibration Coefficient ABX Micros User Manual RABO42IEN 7 ABX Micros GO 2 3 3 HCT The Hematocrit is a combination measurement of electronic pulses and mathematical calculations All the RBC pulses are grouped into various sizes Each group pulse height is then averaged all the pulse height averages are then averaged one final time for a mean average of all the RBC pulse heights This is a function of the numeric integration of the MCV Results are given as a percentage of this integration 2 3 4 MCV MCH amp MCHC MCV Mean Cell Volume is calculated directly from the entire RBC histogram Mean Cell Hemoglobin is calculated from the Hemoglobin value and the RBC count Calculations are as followed MCH pg HGB RBC x 10 pg Picograms MCHC Mean Corpuscular Hemoglobin Concentration is calculated according to the Hemoglobin and Hematocrit values Calculations are as followed MCHC g dl HGB HCT X 100 2 3 5 RDW The RDW Red cell Distribution Width is used to determine erythrocyte abnormaliti
118. ng service menu Main menu 4 Service 2 Open the main door of the ABX Micros GO see 1 3 2 Cover dismantling page 8 3 Now press the Esc key to open the tube holder door 4 Hold the Sample probe mounting bracket on the upper right edge and move the sample probe Downwards until you can see the top of the probe and sample tubing 5 Remove the tubing from the top of the sample probe 6 Place the Small paper cup just below the end of the sample probe 7 Connect a piece of tubing to the tip of the syringe and aspirate the Minoclair 8 Place the free end of the syringe tubing on the top end of the sample probe and flush the probe Verify that the solution is flowing directly into the paper cup If the Sample probe is free from blockage the solution stream will appear to be straight If a blockage is present the solution stream will appear to be flared and or 4 atan angle Flush the probe until the stream is straight 9 Once the sample probe is free from blockage carefully remove the paper cup 10 Re connect the Sample tubing to the top of the probe so that it is air tight 14 RABO42IEN User Manual ABX Micros GO Maintenance amp Troubleshooting Maintenance 11 Hold the Sample probe mounting bracket on the upper right edge and move the sample probe upwards until the tip of the sample probe is about 1 inch below the rinsing block 12 Press the Startup key and verify that the background results are within
119. nning aa Va eee e 3 8 4 1 Preliminatles seal eugancees 3 8 VELIM S 3 8 4 3 Standard mode 3 8 4 4 Automatic Cleaning Cycle 3 8 4 5 End 1 sesssccnrseeviedaiachersnmiccecscavananevdece vesteudsteceweavecsvassungwavecss 3 9 5 Results ccscccssesccsssaccoescecsceccsoossccccsamnsesssscssennsessdsssaansesscesssnaesseecscssssoosstectsssoes 3 10 5 1 ABX Micros 60 05 078 3 10 5 1 1 Displayed Results Ri 3 10 5 125 E 3 10 B oss cuspide al el aaa DU 3 10 5 1 4 Results Printob eS IET ER See EPI PER E D gVUDS Ene DePCEER ENS 3 11 5 2 ABX Micros 60 05 0 16 3 13 5 251 Displayed Results tore entro eo e eee oe Tune e eee Te a exu 3 13 5 22 3 13 Bo M du EE 3 13 5 2 4 Result printout US mode example 3 14 5 3 ABX Micros 60 05 0718 3 15 Ed 3 15 0 1 Normal 1525365 iiec ex eoe oec oe ee eee aas ede acero au qe p ee Eve eoe tua ce evo go oes 3 15 6 2 Flags causing analysis reject eene nnne 3 15 6 2 1 Results Exceeding Linear range
120. nown so far 4 3 Known Interfering Substances their normal range should be performed using reference methods or other standard laboratory procedures for the conclusive verification of these abnormal results The section below starts the list of the known limitations of automated blood cell counters which use the principle of impedance Verification of any Abnormal test result including Flagged results or results Outside 4 4 3 1 HCT Hematocrit Red Blood cell Agglutination May produce erroneous HCT and MCV values Red blood cells agglutination may be detected by observing abnormal MCH and MCHC values as well as examination of a stained blood smear in such cases Manual Laboratory methods may be required to obtain an accurate HCT value 4 3 2 RBC Red Blood Cells Erythrocytes The Red blood cell dilution contains all the formed elements in the blood Erythrocytes Leukocytes and Platelets During the counting of the RBC s Platelets are below the RBC size minimum threshold therefore they are not counted as RBC s Leukocytes White Blood cells on the other hand are included in the RBC count However since the normal ratio between Red blood cells and White blood cells is so extreme the influence of counting the WBC s during the RBC count is negligible High WBC s In rare cases where the WBC s are extremely high the RBC count may be corrected especially if the RBC count is extremely low in comparison to the high WBC
121. nter key to send the last sample results to the Host computer 16 RABO42IEN User Manual ABX Micros GO Setup Barcode Setup 7 Barcode Setup This sub menu will allow the operator to select the types of Barcode labels to be read by the reader Turning the Checksum ON or OFF gives the operator this capability once the Barcode reader has been installed correctly Setting Barcode Main Menu 5 Setup 7 Barcode Press the Enter key to access the CHECKSUM Yes or No sub menu 8 Memory Card This menu will allow the operator to have the option of storing Patient samples on a Memory card or having the Memory card function turned Off This Memory card option allows the operator to store up to 60 patient results on the card if the instrument has a card reader installed Remember the ABX Micros GO will only hold the last sample analyzed in the Internal memory The Memory Card option will allow the operator to perform the following tasks from the memory card It will allow the operator to turn the memory card function On or Off 8 1 Memo On Off page 17 Print a list of all the sample Identifications that have been stored on the card 8 4 Print List page 19 Select one sample result to Print 8 5 Reprint One result page 19 Select all sample results to Print 8 6 Reprint All Results TR ALL page 20 To select from a specific number of samples to be printed 8 7 Reprint From To
122. ny the Histograms if selected in the setup 2 2 Printout This function will disable enable the printout of the WBC RBC and PLT Histograms Selecting histograms for printout Main menu 5 Setup 1 Results 2 Printout Use Up or Down arrow key to select one of the 3 options as follows 1 results printed out with histograms 2 results printed out without histograms 3 results printed out without RBC histogram Press the Enter key to confirm 2 3 Units This sub menu allows the operator to select between 4 different Units of Measurement These units vary from country to country and are designed for international applications Choosing system units Main menu 5 Setup 1 Results 3 Units Use Up or Down arrow key to choose one of the 4 system units as follows 1 Standard 2 SI 3 International 1 4 International 2 Press the Enter key to confirm Available units are detailed in Tab 5 2 System units page 4 Tab 5 2 System units Standard st International 1 International 2 RBC HGB HCT PLT MCV MCH MCHC 103 mm 10 L 103 mm 10 L 105 mm 101 L 105 mm 101 L g dl mmol L g dl g L I L I L 103 mm 10 L 103 mm 10 L um fl fl fl pg fmol pg pg g dl mmol L g dl g L 4 RABO42IEN User Manual ABX Micros GO Setup Results Options Tab 5 2 System units Standard ist International 1 International 2 MPV um fl fl fl LYM 9 9 LYM
123. o TIME OP RBC HGB HCT MCV MCH MCHC PLT 1 01 20 06 09 57 0 2 7 4 4 58 13 6 36 3 79 29 7 37 5 279 2 01 21 06 08 23 0 1 7 3 4 52 13 2 35 3 78 29 2 37 4 247 3 01 22 06 10 57 OP 3 7 3 447 13 4 35 2 79 29 9 380 254 ETC REFERENCE WBC RBC HGB HCT MCV MCH MCHC PLT MEAN 7 4 4 52 13 4 35 79 29 6 37 5 249 LOW 6 8 4 34 128 33 75 27 6 34 5 219 HIGH 8 0 4 70 14 0 37 7 83 31 6 40 5 279 ACTUAL WBC RBC HGB HCT MCV MCH MCHC PLT MEAN 7 4 4 54 13 3 35 5 78 29 4 37 5 252 SD 0 13 0 06 0 16 0 59 0 63 0 43 0 53 11 22 CV 170 1 37 148 167 0 80 1 46 1 40 4 45 ETC Fig 4 2 QC Statistics printout 1 6 Q C Graphs Only with Q C smart card The ABX Micros GO plots Levey Jennings charts for each parameter of the Quality Control files stored on the Q C Smart card Each Levey Jennings chart will plot 1 data point per parameter per control run for every control data point stored Printing Graphs Selecting Graphs Main Menu 2 QC 5 Graphs Press Enter key Use the Up amp Down arrow key to select one of the 3 levels Or select ALL to select the 3 Levels Press Enter key to printout the Graphs The parameter charts are determined by the internal software setup See Section 1 1 1 Parameters page 1 3 for the parameters that are printed out on the Levey Jennings charts ABX Micros User Manual RABO42IEN 9 ABX Micros GO Levey Jennings charts are printed out with the following information i
124. oncentrated cleaning as described in 1 3 6 Concentrated Cleaning page 11 8 Once the cleaning cycle is complete perform a Backflush cycle see 1 Run a backflush sequence page 16 9 Perform the Backflush 2 more times 10 Press the Esc key until you return to the Main Menu 11 Press the Startup key to run a startup Verify that Background results are within their limits 12 Re run Quality Control and verify that the results are within the Assay limits listed on the control Assay sheet that comes with the controls 13 If the problem still persists repeat steps 1 through 11 again 14 If the problem still persists after the second cleaning call your local HORIBA Medical Technical Support Representative 16 RABO42IEN User Manual ABX Micros GO Maintenance amp Troubleshooting Troubleshooting 2 Troubleshooting 2 1 Overview Your ABX Micros GO may occasionally require troubleshooting if System operations are faulty 4 The Background count is unacceptably high Your Quality Control values are out of range or patient results are suspicious e g consistent ly high RBC counts or the inability to verify results by manual methods Precision is poor Calibration is drifting 2 2 Problem Identification The first step in any troubleshooting session is to identify the source of the system malfunction System operation Precision Quality Control Calibration These
125. ontainer RS 232 output connection Used only by HORIBA Medical qualified Engineers Printer connection Do not connect any printer which has not been recommended by a HORIBA Medical qualified Engineer 5 3 Biological risks label This label is located on the left side cover Fig 1 Biological risks ABX Micros User Manual RABOA42IEN 11 ABX Micros GO human blood or serum as potentially infectious Use established good laboratory working practices when handling specimens Wear protective gear gloves lab coats safety glasses and or face shields and follow other bio safety practices as specified in OSHA Blood Borne Pathogens Rule 29 CFR part 1910 1030 or equivalent bio safety procedures Consider all specimens reagents calibrators controls etc that contain QW 5 4 Internal label This label is located on the WBC chamber cover main covers must be opened to reach it Fig 2 ESD label The reagent and chambers are susceptible to cause ESD damage to the instrument motherboard when they are handled without ESD safe handling tools Make contact with the instrument ground cover screw for example before proceeding on the chambers in order to prevent electrostatic discharges W Electrostatic Sensitive Device ESD 12 RABO42IEN User Manual ABX Micros GO 5 5 Identification Label Fig 3 Identification label 6 Intended use HORIBA ABX Rus du Parc Euromadacin
126. oratory Limits page 5 7 Certain Pathological conditions will affect the RDW results See See Section 1 4 3 Known Interfering Substances page 1 14 2 2 12 Calibration coefficients The operator has the option of either Editing the current calibration coefficients or Printing the current calibration coefficients 2 2 13 The ABX Micros 60 is an accurate and reliable instrument when properly maintained Should any variation of Quality Control results outside the Assayed ranges occur after calibration it is Highly suggested that you contact your local HORIBA Medical Technical Support Representative before Manually editing the calibration coefficients Changing Calibration Coefficients Editing calibration coefficients Main menu 3 Calibration 2 Coefficients 1 Calib Coeff Enter password 123 or the one defined by the operator in the setup menu See Section 5 4 2 Changing the User Password page 5 10 Press Enter key Press Up or Down arrow keys to select the coefficient to be edited Press Enter key and enter new coefficient derived from using the below formula Press Enter key to accept the coefficient Continue to use the Up or Down arrow keys to select the next coefficient to be edited Use the same formula below to calculate the remaining coefficients Press the Esc key until you return to the Main Menu New coefficient calculation Parameter target
127. pon the same as the RBC PLT measuring principles The WBC count is performed in the WBC HGB Chamber The electronic signal processing device places and electronic threshold between the WBC s and the PLT s The electronic pulses are then placed into 256 Channels according to pulse size The pulses are then Thresholded grouped then mathematically calculated to create a numerical value for the determination of WBC s 2 3 9 1 WBC Histogram The WBC Histogram is a distribution study that reveals the following 3 types of White blood cell sub populations Lymphocytes Monocytes and Granulocytes The Diluent and Lyse of the ABX Micros GO play very important part when sizing the WBC subpopulations in the WBC distribution curve 2 3 9 2 Differential Measuring principles 9Diluent and Lysing action The Diluent preserves and prepares the WBC cell membrane for the differential reaction The Lysing reagent has a differential mode of action on the WBC cytoplasmic membranes When the Lyse reacts with the Lymphocyte cytoplasmic membrane it allows the release of water soluble cytoplasm and shrinks the membrane around the nucleous When the Lyse reagent reacts with the Monocyte cytoplasmic membrane it has an intermediate reaction which keeps the cell somewhat stable maintaining its large size in comparison to the lymphocytes ABX Micros User Manual RABO42IEN 9 ABX Micros GO When the Lyse reagent reacts with the Granulocytes it ha
128. rd to be transmitted to Printer or External computer The Memo functions for both printer and external computer include Print list of sample ID s to Printer or Computer 8 4 Print List page 19 Print one result to Printer or Computer Print all results to Printer or Computer Print specific numbers of sample results to Printer or Computer 18 RABO42IEN User Manual ABX Micros GO Choosing transmission mode Main menu 5 Setup 7 Memo Card 2 Transmission Select 1 Printer in order to transmit the memory card results to the connected printer Setup Memory Card or 2 Host comp in order to send the results to the external host computer via RS232 port Press the Enter key 8 4 Print List This Memory card sub menu allows the operator to print out a complete list of all the sample Identification numbers on the card This Sample Identifictaion list will include the following information MEMO Number in sequence The date of the analysis The Time of the analysis The Sample Identification number entered by the operator Main menu 5 Setup 7 Memo Card 3 Print List Press the Enter key PRT LIST MEMO DATE TIME 1 07 21 1999 11 45 2 07 21 1999 11 47 3 07 21 1999 11 48 4 07 21 1999 11 53 5 07 21 1999 11 55 6 07 21 1999 13 34 NAME 12 456 675 984 R456 ABC123 Fig 5 3 Printing list example 8 5 Reprint One result This Memory card sub menu allow
129. recommendations 4 11 2 1 1 Preliminaries E 4 11 2 1 2 Calibration procedure ccccsssssccceescecceseeceessscecensccceeeeeeeeeeeeceeeesces 4 11 2 2 Ia pnepbap en 4 11 2 2 1 Change lot number 4 12 2 2 2 Change Expiration date 4 12 2 2 3 Changing the target value 4 12 2 2 4 Change number of calibration samples 4 12 2 2 5 Running calibrator eeeeseeeee eese eene nennen eene eene ente 4 13 2 2 6 Calibration Results eer Enter ee ee teen pe pen ne nna PESE ETAT 4 13 2 2 7 Verify Calibration 4 14 2 2 8 Calibration Passed 4 15 2 2 9 Calibration Failed esee eene nennen ente nnne 4 16 2 2 10 RDW Calibration IE ee pee nea Pe aee eee oe eee etes Vea saa aiaia 4 17 2 2 11 RDW calibration using a Quality Control Standard 4 17 2 2 12 Calibration coefficients 4 18 2 2 13 Changing Calibration Coefficients cccssssecccssscceeseeeceeeeeceeesees 4 18 2 2 14 Calibration Coefficient limits
130. rify the precision of the instrument it is recommended to run a Fresh Normal Whole blood sample 10 times mixing between each analysis cycle After all 10 run are complete calculate the Coefficient of Variation percentage CV Compare the CV results with those listed See Section 1 3 3 Precision Repeatability page 1 10 If the precision of any parameter is not within these specifications identify the out of range pa rameter s and initiate appropriate troubleshooting procedures Calculation factors for CV determination xi n X X SD ja XXn n 1 XI Definitions X the calculated Mean n the total number of samples Xi the individual parameter value SD Standard Deviation CV SD x 100 X the CV s have been calculated compare them to the specified limits 2 2 4 Calibration If the system seems to be operating properly fresh uncontaminated reagents are being used and the precision is within the specifications the ABX Micros GO may need calibration See Sec tion 4 2 Calibration page 4 11 2 3 Troubleshooting Parameters The procedures described below should be performed whenever the precision of a parameter is not within its CV specifications or the parameter is incorrect or suspicious When all parameters are affected it is necessary to look for a common cause e g Vacuum pres sure sample aspiration chamber filling and draining correctly common reagent pollution
131. rms a complete cleaning with the enzymatic detergent Miniclean and puts the system into a Standby mode The ABX Micros GO can then be switched OFF at the end of the working day or left in this Standby mode until the next working day It also may be left in the Standby mode between long breaks during the day When the ABX Micros GO is left in the standby mode it is mandatory to perform a STARTUP cycle before returning to any analysis cycles ABX Micros User Manual RABO42IEN 9 ABX Micros 6O 5 Results When an analysis cycle has been complete results are displayed and printed out according to the Setup of the Instrument 5 1 ABX Micros GO OS OT8 5 1 1 Displayed Results The Parameter results are displayed on the LCD screen once the analysis cycle is complete 5 1 2 Identification The sample identification can be reviewed on the LCD screen 5 1 2 1 US Mode Sample identification review Results menu Up or Down Arrow keys 5 1 2 2 Standard Mode Run identification review Results menu Up or Down Arrow keys 5 1 3 Flags The PLT flags can be reviewed on the LCD screen PLT flag review Results menu Up or Down Arrow keys The Last sample result run can be displayed again at any time before running the next analysis results identification flags Last Run results review Main Menu 1 Results Up or Down 10 RABO42IEN User Manual
132. s a limited reaction due to a molecule in their cytoplasmic structure which protects them from shrinking action of the lyse This inturn makes the Granulocytes the larger of the WBC sub populations in the cell differentiation After the Differential lysing action the ABX Micros GO analyses the height of each electronic pulse as the WBC s pass through the Micro aperture The pulses are then Channeled Thresholded grouped according to their size from 30fl to 450fl and calculated mathematically to create the WBC distribution curve which inturn is known as the WBC Histogram The 3 sub populations of WBC s are placed accordingly as to the number of cells and size of the cells in each group The distribution of the WBC sub populations are as followed Lymphocytes are between 30 1007 The Monocytes are between 100 150fl The Granulocytes are between 150 450fl This inturn creates the term LMG s for a 3 part WBC differential on the ABX Micros GO The Granulocytes subpopulation of the WBC s contains 3 sub populations within itself which are somewhat the same in nature 4 They all contain Cytoplasmic granuler material which stain various colors when viewed microscopically These 3 sub populations are as followed Neutrophils Eosinophils Basophils The distribution of these cells depends on the pathological and physiological conditions of the individuals analyzed distribution curve Mobile and Fixed Alarm flags will alert the l
133. s the operator to select one specific sample results from the card to be printed out That one sample results will be printed out according to the Results printout options from the RESULTS Menu such as PRINTOUT With Histograms Without Histograms Without RBC Histogram Only UNITS Standard SI Inter 1 Inter 2 ABX Micros User Manual RABOA42IEN 19 ABX Micros GO 4 PRINT LIMITS Yes or No 4 PRINT LMG s Yes or No Proceed as follows 1 Place the Memory card in the reader Printing One Result Main menu 5 Setup 7 Memo Card 4 TR One Press the Enter key Enter the MEMO number next to the sample ID number of the sample results to print the MEMO number must be known previously Press the Enter key 8 6 Reprint All Results TR ALL This Memory card sub menu will allow the operator to select all the results on the card to be printed out Verify that you have a sufficient quantity of paper in the printer for this function Each individual results will be printed out on a separate sheet of paper 1 Place the Memory card in the reader Printing All Results Main menu 5 Setup 7 Memo Card 5 TR All Press the Enter key the Esc key Wait until the printer has stopped before continuing through the sub v If you selected 5 TR ALL by error remove the memory card from the reader and press menu 8 7 Reprint From To TR FROM TO This memory card sub menu will allow the
134. se the Number keys to enter the numbers directly Use the Up and Down arrow keys to select each alpha character Press the Enter key after each alphabetical selection Then the analyzer checks to see if there is a memory card present in the card reader If the memory card has not been inserted a message will appear on the display as indicated Error No smart card Insert new card If a wrong card is inserted instead of a memory card a message will appear on the display as indicated Error Bad smart card Insert new card Remove the card insert a memord card and press the Enter key If the operator inserts the memory card in the wrong way a message will appear on the display as indicated Error Bad card insertion Insert new card Remove the memory card place the chip in the Up position and forward to the point of insertion Insert the card and press the Enter key If the memory card is full insert a new memory card and press the Enter key or print out all the results of the full card clear these results from the card and re insert the memory card then press the Enter key suggested to print out All the stored results from the card before using a new card or The Memory card can store up to 60 results When the card is Full it is highly clearing the full card 8 3 Transmission of Results This sub menu allows the operator to select as to where they want the results from the memory ca
135. sual values of the laboratory 2 2 Calibration function The ABX Micros GO Calibration can be achieved in 2 different ways 1 Calibration is performed using a Calibrator Blood sample 2 Known Calibration Coefficients can be directly entered by selecting a Calibration Menu option ABX Micros User Manual RABOA42IEN 11 ABX Micros GO Accessing the calibration function Main Menu 3 Calibration 1 Autocalibration Select one of the 4 operators 0 P defined in Section 5 4 1 Changing Operator page 5 10 Press Enter Key 2 2 1 Change lot number From the previous screen See 2 2 Calibration function page 11 proceed as follows to change the calibrator lot number Changing lot number Insert new card message is displayed Press the Esc key in order to edit all the calibration information Manually Press the Enter key to enter the new lot number of the calibrator material Lot message is displayed Enter the new Lot of the current calibrator Use the Up and Down arrow keys to enter the Alpha characters Use the Numeric keys to enter the Numbers Press the Enter key to save the new lot number 2 2 2 Change Expiration date From the previous screen See 2 2 1 Change lot number page 12 proceed as follows to modify the Expiration date Changing Expiration date Change Exp date message is displayed Press the Enter key Enter the new expiration date from
136. t Perform a Concentrated cleaning 1 3 6 Concentrated Cleaning page 11 re run sample Perform a concentrated cleaning 1 3 6 Concentrated Cleaning page 11 re run sample Check syringe blocks for leakage and call HORIBA Medical Technical support Re calibrate and rerun QC See Section 4 2 Calibration page 4 11 Perform a concentrated cleaning 1 3 6 Concentrated Cleaning page 11 re run sample Check syringe blocks for leakage and call HORIBA Medical Technical support Perform a Concentrated cleaning 1 3 6 Concentrated Cleaning page 11 re run sample Mix sample just before pressing the Manual sample bar for each sample Maintenance amp Troubleshooting 2 3 3 Problems on WBC HGB parameters only Tab 6 4 Troubleshooting Problem Noted Possible Cause Corrective Action Startup Failed No results in analysis Very high results on WBC HGB Suspicious patient results QC outside acceptable limits Poor repeatability Possible dirty aperture Possible partial blockage in sample probe Possible leakage from syringe block Possible contaminated reagent s Possible bad HGB blank reference voltage Possible dirty apertures Has Diluent been delivered correctly into WBC chamber Possible lyse flow error Possible Fibrin clot in T fitting be low WBC chamber Possible dirty Aperture Possible leakage from syringe blocks Possible dirty chamber Possible dirty apert
137. t can be adjusted as followed 1 Once you have accessed to the Chg Contrast Menu as described in 1 3 7 Mechanical Checks page 11 press the Enter key 2 Press the Up arrow key to increase the contrast or press the Down arrow key to reduce the contrast 3 When the contrast is set press the Enter key to accept the change in contrast The Contrast Menu can be accessed at any time from any other menu press and hold the Q Delete DEL key and Period key simultaneously 4 12 RABO42IEN User Manual ABX Micros GO Maintenance amp Troubleshooting Maintenance 1 4 Instrument Cycles This Service function provides the number of cycles the ABX IMiicros GO has run This cycle menu will contain 3 cycles to view as indicated 1 Startup the number of Startup cycles that the instrument has ran 2 Standby the number of Standby cycles that the instrument has ran 3 CBC the number of analysis cycles that the instrument has ran Viewing cycles number Main menu 4 Service 6 Cycles Use the Up and Down arrows 1 5 Technician Functions This Service function allows the operator to work with HORIBA Medical Technical Support in resolv ing checking and or adjusting some technical operations on ABX Micros GO This Service Menu is mainly used by the Engineers to make adjustment in the technical areas of the analyzer This Menu can be accessed only by a special password When tro
138. t not be handled or checked by the user Electrical power supply Electronic circuit boards Operator injury may occur from an electric shock Electronic components shock and injure the user Do not tamper with the instrument and do not remove any components covers doors panels and so on unless otherwise instructed within this document Moving parts It is strictly forbidden to disable sensors as it may cause operator injuries Protection covers must not be opened during instrument operations The battery may explode if it is not replaced correctly Replace only with the same or equivalent type recommanded by the manufacturer Dispose of used batteries according to the manufacturer s instructions 2 3 Biological risks A Consider all specimens reagents calibrators controls etc that contain AD human blood or serum as potentially infectious Use established good laboratory working practices when handling specimens Wear protective gear gloves lab coats safety glasses and or face shields and follow other bio safety practices as specified in OSHA Blood Borne Pathogens Rule 29 CFR part 1910 1030 or equivalent bio safety procedures HORIBA Medical uses disinfectant product for instrument decontamination and highly recommends it to decontaminate your instrument See Section 6 1 1 3 General Cleaning of the Instrument page 6 3 3 Working conditions 3 1 Environment The operation of the ABX GO
139. t to unplug several times the same reagent pack 1 2 4 Diluent amp Waste connection Connect the diluent container using the diluent straw and a 3 x 6 cristal tube 1 meter maximum on the diluent input located at the bottom of the instrument rear panel Connect the waste container using the cristal tube 3 x 6 on the waste output and place the waste container below the instrument level under the bench DILUANT DILUENT Fig 6 7 Rear connections Always follow the recommended procedures for waste disposal Never connect the in strument wastes directly to the laboratory drain pipes 1 2 5 Reagent priming 1 2 5 1 Bottles and containers set Step to 1 3 5 Prime Reagents page 10 to run the priming of the replaced reagent 1 2 5 2 Reagent pack Step to 1 3 5 Prime Reagents page 10 to run the priming after the pack replacement It is recommended not to remove the pack several times before the reagents are totally W used in order to avoid leak problems ABX Micros User Manual RABO42IEN 7 ABX Micros GO 1 3 Service Functions Several service functions are available for the operator to clean and check the instrument 1 3 1 Menu Service overview Tab 6 1 Menu VService overview SERVICE 2 Drain chambers 4 Concentrated Cleaning 6 Cycle 1 Startup 2 Standby 3 CBC 8 Autoclean 1 3 2 Cover dismantling Using the key from the installation kit turn the locker
140. the Calibration Assay sheet Use the arrow keys after entering the Month Use the arrows key after the Day Press the Enter key to save the new expiration date 2 2 3 Changing the target value From the previous screen See 2 2 2 Change Expiration date page 12 proceed as follows to modify the target values Changing target values Change target WBC message is displayed Press the Enter key Enter the new target value for WBC from the Calibration Assay sheet Press the Enter key to save and move to the next entry The next screen will indicate changing the RBC target value Repeat the same steps for RBC HGB HCT PLT and MPV 2 2 4 Change number of calibration samples From the previous screen See 2 2 3 Changing the target value page 12 proceed as follows to modify the number of samples to be run for calibration 12 RABO42IEN User Manual ABX Micros GO Quality Assurance Calibration Changing sample number Change sample message is displayed Press the Enter key Enter the number of samples you wish to run for calibration or press the Esc key of 11 In order for the instrument to provide the best mathematical data for a good calibration a Minimum of 6 sample runs is highly recommended for quality statistical calibration data The number of samples you can run for calibration is a Minimum of 3 and a Maximum 2 2 5 Running calibrator From the previous screen Se
141. the WBC Histogram with an L1 Alarm or as an elevated baseline on the Left leading edge of the Lymphocytes population in the WBC Histogram Non lysed erythrocytes will also cause a falsely elevated WBC count Following the Manual differential white blood cell count the WBC assay value Must be corrected to subtract the NRBC s from the total white blood cell count This will give a true and correct count of the actual WBC s Multiple Myeloma The precipitation of proteins in Multiple Myeloma patients may give elevated WBC counts Hemolysis Hemolyzed specimens contain Red cell Stroma which may elevate WBC counts Leukemia A very low WBC count may result in this disease state because of possible increased fragility of the leukocytes leading to some destruction of these cells during counting These white cell fragments will also interfere with the white cell partial differential parameters LYM and MON and GRA and A suspiciously low WBC count may also be seen in patients with Lymphocytic Leukemias due to the presence of abnormally Small lymphocytes which may not be counted by the instrument Chemotherapy Cytotoxins and Immunosuppressive drugs may increase the fragility of the leukocytes which may cause low WBC counts Cryoglobulins Increased levels of Cryoglobulins that may be associated with Myeloma Carcinoma Leukemia Macroglobulineima Lymphoproliferative disorders Mestastic turmors Auto immune disorders In
142. the cap from the blood collection tube before analyzing any sample OT and OS are indicated in the instrument serial number that identifies the 4 unit and model 8 Installation An HORIBA Medical representative will install your instrument software and printer 8 1 Package contents A thorough inspection is carried out on the ABX Micros GO before sending it We nevertheless recommend checking the total system as soon as it is received to report any anomalies to the carrier Verify that all of the parts from the package list are present The ABX Micros 05 0 boxes contain the following parts Instrument Printer User manual CDROM RAX056A Reagents controls amp calibrators CD ROM Daily guide RAB180 Power cable european DACO11A or power cable US DACO12A Installation kit Bottle or Pack 8 1 1 Bottle Installation kit The ABX Micros GO 0T bottle installation kit XEA 314 B includes Tab 2 Bottle installation kit DESIGNATION PART NUMBER Reagent straw L 270 mm XEA017A 3 Sampling needle GBCO69AS 1 Diluent Waste male connector EACO19A 2 Cristal tube 3x6 EAE011A 4 0 ring 6x1 5 FAA036A 1 0 ring 1 4x1 25 FAA0053A 2 Rubber stopper 2 holes FBLOO1A 1 Reagent bottle stopper XDA566A 2 14 RABO42IEN User Manual ABX Micros GO Introduction Installation Tab 2 Bottle installation kit Common installation kit XEA312B 1 8 1 2 Pack installa
143. the chamber After the solution has been added to both chambers press any key to continue The cleaning cycle will begin and a cleaning time will be displayed This concentrated cleaning cycle involves different cycles backflush aspiration rinsing which al low a good cleaning of the chambers and apertures After this procedure is complete perform a STARTUP cycle to verify that the background parameters are within their limits Once the Startup cycle has passed sample analysis may begin 1 3 7 Mechanical Checks This service function will allow the operator to move through a sub menu full of mechanical move ments that will allow them to select a specific mechanism for function verification If the operator suspects a specific mechanical failure they may then verify it in this menu If needed dismantle the covers as described in 1 3 2 Cover dismantling page 8 Running mechanical checks Main menu 4 Service 5 Mechanic Select between the 9 below functions ABX Micros User Manual RABOA42IEN 11 ABX Micros GO 1 Check Sensors Needle and Carriage This allows the operator to check the homing sensors of the sample probe and the sample carriage 1 3 7 1 Check sensors test page 12 2 Needle U D This allows the operator to check the Up and Down movement of the sample probe 3 Carriage L R This allows the operator to check the Left to Right movement of the sample carriage 4 Liquid Syringe T
144. the differential resistance of cytoplasmic membranes in the different cell types pathological elements can be found in a number of different zones This also applies to presence of Normal or non pathological cells that have been subjected to Chemotherapy or some other form of treatment which affects the alarm zones These types of treatments will result in False alarms v All Anomalies and or Abnormal distribution flags given by the ABX Micros 60 18 RABO42IEN User Manual ABX Micros GO Quality Assurance Contents 1 Quality Control 21 1 oreet perire etre eara cescdcccescicseevecensedcccescesdstsscctentscdsececcssasestsce 4 2 1 1 Ee ae aaen 4 2 1 2 Q C Automatic With Q C Smart Card 4 2 1 2 1 QC Smart card messages 4 3 1 2 2 Select Operator eene eene nennen nnne enne tense nnne 4 3 1 2 3 Select commercial control level 4 3 1 2 4 Running Control blood esses eene eene nennen nnne 4 4 ECC p 4 5 1 2 6 Accepting or Rejecting QC 4 5 1 3 Q C Analysis Without Q C Smart Card 4 7 1 4 Q C print targets only with Q C smart card 4 7 1 5 statistics only with Q C smart card 4 8 1 6 Q C Graphs Only with Q C smart card 4 9 reir B 4 11 2 1 General
145. tion kit The ABX Micros 60 01 pack installation kit XEA 332 B includes Tab 3 Pack installation kit DESIGNATION PART NUMBER Sampling needle MICROS 60 CT GBCO69AS 1 0 ring 6x1 5 FAA036A 2 O ring 0 74x1 02 FAA053A 2 Common installation kit XEA312B 1 8 2 Reagent connections See Section 6 1 2 Reagent connections page 6 4 ABX Micros User Manual RABOA42IEN 15 ABX Micros GO 16 RABO42IEN User Manual ABX Micros GO Introduction User manual contents 9 User manual contents Introduction 2 Warning and precautions es eie eee reni e to een rao ee NER ERR Ree seai kaien adag Introduction 4 Working COMCIFIONS k cess fecesstcsascnucectGetsscacedecuavsshenssasasesseudsaaestensces Introduction 5 Graphics and symbols e eres secrete eio nar see Ree Eee Rae ea Introduction 8 Introduction 9 Intended use Introduction 11 Presentation Introduction 11 Installation Introduction 12 User manual INE Introduction 15 User manual modifications eene eene nnne Introduction 16 1 Specifications assise vepres REFERS APER MEE 1 1 Techtical Specifications V1 7 0 esos eee aea ede hn ae ko Tea Er rea eae eet vo kao e iura 1 3 i EXE Ue Te Rc
146. ty Apertures Possible Fibrin clot in T fitting be low WBC chamber Possible dirty apertures Possible leakage from syringe block Possible Fibrin clot in T fitting be low WBC chamber Poor calibration Possible dirty apertures Possible leakage from syringe block Possible Fibrin clot in T fitting be low WBC chamber Poor calibration Possible Fibrin clot in T fitting be low WBC chamber Possible Vacuum Waste syringe malfunction ABX Micros Check syringe block for leakage and call HORIBA Medical Technical support Call HORIBA Medical Technical support Perform a Concentrated cleaning 1 3 6 Concentrated Cleaning page 11 re run Sample call HORIBA Medical Technical support Perform a concentrated cleaning 1 3 6 Concentrated Cleaning page 11 re run sample Check syringe block for leakage and call HORIBA Medical Technical support Call HORIBA Medical Technical support Re calibrate and rerun QC See Section 4 2 Calibration page 4 11 Perform a concentrated cleaning 1 3 6 Concentrated Cleaning page 11 re run sample Check syringe block for leakage and call HORIBA Medical Technical support Call HORIBA Medical Technical support Call HORIBA Medical Technical support Call HORIBA Medical Technical support check syringe correct operation as de scribed in 1 3 7 Mechanical Checks page 11 GO User Manual 421 19 ABX Micros GO 2
147. ubleshooting your in Q strument in this area call your local HORIBA Medical Technical Support Representative for the special password and instructions in this menu area 1 6 Automatic Cleaning Provides an automatic Cleaning cycle to run at any time when the operator wishes to clean the instrument Running cleaning Main menu 4 Service 8 Autoclean Press the Enter key Fibrin clots in the apertures and or chambers If this is the case a Concentrated Clean This Auto Clean cycle is short cycle and may provide enough cleaning action for ing is highly recommended see 1 3 6 Concentrated Cleaning page 11 1 7 Manual Probe Cleaning Concerns Unblocking Sample probe Replacing Sample probe Instrument Response Problem type Low results on all parameters in any analysis mode ABX Micros User Manual RABO42IEN 13 ABX Micros GO results on all parameters in any analysis mode Possible high backgrounds on Startup Required Tools 5 or 10ml syringe Absorbant paper 45 inch small diameter tubing Small paper Required Products ABX MINOCLAIR 0 5L P n 0401005 or bleach containing 1295 active chlorine Intervention time Approximately 15 minutes Frequency needed In case of partially blocked probe Bent probe Specific Kits or Consumable products Sample probe p n GBCO69AS 1 7 1 Unblocking the Sample Probe Procedure 1 Enter the service Menu Enteri
148. ure Possible leakage from syringe blocks Poor calibration Possible dirty apertures Possible leakage from syringe blocks Possible dirty chamber Incorrect sample mixing ABX Micros Perform a concentrated cleaning 1 3 6 Concentrated Cleaning page 11 re run sample Remove and flush out sample probe as described in Section 6 1 7 Manual Probe Cleaning page 6 13 Check syringe block for leakage and call HORIBA Medical Technical support Check and or replace reagent s if necessary Call HORIBA Medical Technical sup port for assistance Perform a concentrated cleaning 1 3 6 Concentrated Cleaning page 11 re run sample Check for diluent delivering into cham ber call HORIBA Medical Technical support Check and or replace Lyse reagent Call HORIBA Medical Technical support Perform a Concentrated cleaning 1 3 6 Concentrated Cleaning page 11 re run sample Check syringe blocks for leakage and call HORIBA Medical Technical support Perform a Concentrated cleaning 1 3 6 Concentrated Cleaning page 11 re run sample Perform a concentrated cleaning 1 3 6 Concentrated Cleaning page 11 re run sample Check syringe blocks for leakage and call HORIBA Medical Technical support Re calibrate and rerun QC See Section 4 2 Calibration page 4 11 Perform a concentrated cleaning 1 3 6 Concentrated Cleaning page 11 re run sample Check syringe blocks for leakage an
149. ve the sample probe upwards until the tip of the sample probe is about 1 inch below the rinsing block 13 Re connect the sample tubing to the top of the probe so that it is air tight 14 Hold the Sample probe mounting bracket on the upper right edge and move the sample probe upwards until the tip of the sample probe is about 1 inch below the rinsing block 15 Press the Startup key and verify that the background results are within their limits 16 Re run the Quality Controls to verify correct results 1 8 Extended Concentrated Cleaning Concerns ABX Micros User Manual RABOA42IEN 15 ABX Micros GO RBC PLT Chamber and Aperture cleaning WBC HGB Chamber and Aperture cleaning Required Tools 5ml or 10ml syringe Required Products ABX MINOCLAIR 0 5L P n 0401005 or bleach containing 12 of active chlorine Intervention Time Approximately 30 minutes Specific Kits or Consumable products None Procedure 1 Run a backflush sequence Running Backflush Main menu 4 Service 1 Backflush 1 Perform a Backflush cycle 2 more times 2 Drain the chambers Draining chambers Main menu 4 Service 2 Drain chambers 3 Open the main door of the ABX Micros GO see 1 3 2 Cover dismantling page 8 4 Locate the opening on the top of the chamber shield or not 5 Fill both chambers with 5ml of the ABX MINOCLAIR 6 Let the solution set for 10 minutes in the chambers 7 After 10 minutes run a C
150. warm up period for the internal electronics Once the instrument warm up phase is complete the front panel L E D will turn from Red to Green indicating that the initialization phase is complete The ABX Micros GO will now automatically run a STARTUP cycle if and only if the instrument has been programmed for an Auto Startup cycle see Section 5 4 3 Choosing Startup Cycle page 5 11 If the ABX Micros GO does not automatically run a Startup cycle after the initialization phase is complete press the Startup key on the instrument front panel to initiate the cycle The ABX Micros GO will perform a Startup cycle which primes all the reagents checks the electronics and mechanical movements Then the instrument will perform a blank cycle for a Background count an analysis cycle based on reagents without any blood sample The instrument then prints out the blank cycle results Background Limits Check and verify that the Background counts do not exceed the following parameter limits WBC 0 3 10 RBC 0 02 10 mm HGB 0 3 g dl PLT 10 103 mm If the Background count is above any of the parameter limits the ABX Micros GO will automatically perform another STARTUP cycle If the Problem persists after 3 consecutive cycles a message will be printed out stating Startup Failed Refer to the Maintenance and Troubleshooting See Section 6 2 Troubleshooting page 6 17 for identifying and resolving the problem in qu
151. wed to avoid possible damage to the instrument or erroneous test results NOTA Emphasizes important information especially helpful to the operator before during or after a specific operational function ABX Micros User Manual RABO42IEN 5 ABX Micros 6O 2 Warning and precautions Work safety reliability and general characteristics are guaranteed by HORIBA Medical under the following conditions User manual must be enterely read and personnel trained by HORIBA Medical before attempt ing to operate instrument The user always operates with full knowledge and appreciation of instrument warnings alarms and flags Always refer to labeling and HORIBA Medical instructions in order to avoid to compromise system integrity The instrument must be operated as instructed in the user manual Any other use might compromise system integrity and might be hazardous for the operator The reagents and accessories stipulated by HORIBA Medical have been A validated in accordance with the European Directive for in vitro medical devices 98 79 CE The use of any other reagents and accessories may place at risk the performance of the instrument engaging the users responsability In this case HORIBA Medical takes no responsability for the device nor for the results rendered Disposal gloves eyes protection and lab coat must be worn by the operator Local or national regulations must be applied in all the operat

Horiba ABX Micros 60 - User manual

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