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HumaCount 30TS and 60TS

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1. mmm ae e ame EEE e CE EEE EEE e a mue EEE CE amm mm lt lt V4 DilChamber a gt V3 Cleaner Puffer gt A 5 Reservoir Tom m V5 LyseWBC 1 2 CLEANER Diluent Lyse V7 Aperture ILILIIL ale 7 Micro dilutor 69 LYSE ee x V6 DrainChamber X V8 Drainchamber e V11 DrainPuff r 3 way Mm Stepper Motor IXE 2 way Vave vale Closed Off 1 3 Off Open 2 3 On For better mixing the macro syringe pushes some air bubbles aspirated through the washing inlet of the chamber and V9 after the lysing process through V4 Off V10 On V9 Off Human N 48 5 3 4 COUNTING PROCESS The regulated vacuum it is generated by the pump in the puffer reservoir aspirates the diluted sample WBC RBC from the chamber through V11 valve There is no volume limiter in the system the instrument counts the cells for 16 seconds in counting phases WBC and RBC FIGURE 45 4V2 DilNeedle V1 DilWash i 3 ee oe n e ED mee ED P BUR dde DILUENT uffer X Reservoir 4 CLEANER Micro dilutor
2. iN yo SWay TE 2 way Valve or Valve Closed Off NP 1 3 0ff Open 2 3 Stepper Motor For noise prevention there is no mechanical or electronic activity during the counting process and the door should be closed for better shielding HumaCount 30TS 60TS Service manual OPERATION OF THE FLUIDIC SYSTEM 5 3 5 CHAMBER DRAINING PROCESS Chamber draining is made under pressure control Pump drains chamber while puffer reservoir and thus the pressure sensor is connected to the draining tube The instrument can detect the empty state of the chamber from drop of vacuum V2 DilNeedle V1 1 gt ST V4 DilChamber Cleaners DILUENT Hess sik VA _ _____ _____ V5 LyseWBC I GLEANER Diluent Diluen Lyse Bl Micro dilutor 49 LYSE E women De Drainchamber un ERE NT 7 7 4 bacaca a n a n a n a n n cia m mm m m m m Sample P pag Peg ge eg eg egg ee gge egg H motor es Pump 1 lt ee p CR ump 2 a an 1 iN A2 sway Te Mm Stepper Motor TU 2 3 On 49 FIGURE 46 Human AN FIGURE 47 5 3 6 CLEANING PROCESS The pump aspirat
3. CLEANER Macro Micro dilutor Dil m 2 1 V10 DrainPutfer Sample motor 3 wa ai Stepper Motor XE 2 way Valve vane WASTE Closed Off 3 1 3 For better mixing the macro syringe pushes some air bubbles aspirated through the washing inlet of the chamber and V8 after the lysing process through V4 Off V3 On V9 Off V8 On Human N 42 5 2 6 COUNTING PROCESS The regulated vacuum it is generated by the pump in the puffer reservoir aspirates the diluted sample WBC or RBC from the chamber through V7 On valve There is no volume limiter in the system the instrument counts the cells for 8 5 seconds in both counting phases WBC and RBC FIGURE 39 V4 DilNeedle 4 EIE M Dilchamber v V5LyseWbc DILUENT 1 2 i Pressure CLEANER Puffer L Reservoir Macro Lyse Micro dilutor Dil 3 LYSE v2 DilWash y d X to Sample V10 DrainPuffer H motor 3 way 2 1 Stepper Motor 2 way vawe Closed Off IS 4 3 Off Open On 2 3 On For noise prevention there is no mechanical or electronic activity during the counting process and the door should be closed for better shielding HumaCount 30TS 60TS Service manual OPERATION OF THE FLUIDIC SYSTEM 5 2 7 CHAMBER DRAINING PROCESS 43 Chamber draining is made under pressure
4. HumaCount 30TS 60TS Service manual SAFETY INSTRUCTIONS 9 Notes Human E A A HumaCount 30TS 60TS Service manual INTRODUCTION 2 INTRODUCTION Since HumaCount 305 and HumaCount 60 have so much common characteristics we issue a common Service Manual covering both instruments Information herein applies for all instruments unless otherwise noted To be well up in the instruments please read this manual carefully to have the knowledge for servicing the instruments perfectly and avoid extra costs and wasting precious time In this manual we are using the following conventions HC3OTS stands for HumaCount 307 HC60TS stands for HumaCount 607 This HumaCount 307 HumaCount 60 Service Manual contains the functional descriptions of all analyzers operation of the fluidic systems adjustments and settings and very important information for the service personnel about the service operations and possible problems 2 1 Name and serial number Name HumaCount 305 HumaCount 60 Hematology Analyzer Every instrument has its own serial number which is printed on the rear panel label and it can be read out from Device In formation or from the self test submenu This identity number is write protected by HUMAN Serial No 2 2 Integrated software The integrated software controls the instrument operations displays stores recalls data and allows the user to perform OC and calibration procedures and modify th
5. The software is not compatible with the mechanics or rela ted valve is bad partly clogged or the tubing is clogged loose Lyse path guides in noise during counting if the a liquid in the draining tube is touching lyse reagent in T fitting noise can appear Check the lyse path and the lyse valve as well HumaCount 30TS 60TS Service manual MAINTENANCE 71 9 MAINTENANCE 9 1 Weekly User Maintenance Perform weekly maintenance before turning on the power switch The right side has a side door giving access to the fluidic system and the mechanical parts easily 9 1 1 CLEANING NEEDLE WASHING HEAD Needle washing head cleans the outer surface of the aspirating needle with di luent Any salt build up on the lower surface may cause malfunction during operation Use a soft cloth or wiper dampened with water to clean this area You can see the washing head indicated in the following figure FIGURE 57 HumaCount 60 TS chambers 1 Washing head 2 Measuring chambers 3 Measuring apertures Human N FIGURE 58 HumaCount 30 chamber 1 Wash head 2 Measuring chamber Exit Measure menu Open the side door after the needle has stopped moving Gently rub the lower surface of the washing head with a damp cloth or wiper to remove the salt build up 3 Close the side door 9 2 Periodic Maintenance by Service The instruments should be checked and maintenance must be carried out in every 6 12 months or after 10 000
6. 1 ml of diluent This method prevents the chamber from dirt and makes the diluting process faster The sampling process has aspirated 25 uL of sample which is in the sampling needle In the first diluting step the sample is dispensed into the measuring chamber with 3 ml of diluent which comes from the Diluent syringe through V2 On and Micro dilutor while the M3 Dilutor motor moves upwards This pro cess makes the 1 160 first dilution rate in the chamber DILUENT Puffer Reservoir V5 LyseWBC 1 2 lt gt SZ gt V10 Diluent V7 Aperture a Didnt Micro dilutor 4 SZ L 5 E 5 2 3 3 3 way 2 1 1 2 2 way Valve Stepper Motor SX y TU Valve m pp Closed Off 1 3 Open 3 WASTE 2 3 On The second sample 25 uL of primary dilution is made right after the first dilution The second dilution is made in the RBC chamber HumaCount 30TS 60TS Service manual OPERATION OF THE FLUIDIC SYSTEM 47 5 3 3 LYSING PROCESS In this step the set lysing reagent is added into the measuring chamber through V10 On while the Lyse syringe moves upwards This process makes the WBC HGB dilution with lyse reagent FIGURE 44 2 V2 DilNeedle V1 DilWash J
7. 15 present maybe relocation does not solve your problems sometimes the electric power supply makes the coupling so UPS solves the problem Another source of coupling in external noise can be the reagent tanks and tubes Especially radio transmitters can cause problems of radiating so that even the reagents diluent guides in the noise A metal pack for the diluent tank then a good earth grounding of this metal box allows this coupling to disappear forever 8 1 4 INTERNAL NOISE SOURCES The most annoying but real cause is some sort of internal noise The reason for this phenomenon is that inside electrode hot point of the measuring circuit must be well insulated from surrounding electronics otherwise inside noise sources can take their effect 8 1 4 1 Bad chamber insulation Bad shielding of the chamber floating shield couples signals to the chamber and does not prevent against them Check grounding of shield remove it and clean the surface between the shield and the metal base Bad reference electrode connection floating ground reference Repair is required Bad sealing of aperture Replacement of measuring tube is required Broken measuring chamber starts to conduct through the gaps ground path Replacement of chamber is required Contaminated draining tube starts to conduct due to protein or lipid build up It is very easy to identify this case After replacing the drain tube of the HumaCount 30TS 60TS Se
8. 9988 0 Fax 49 6122 9988 100 eMail human human de www human de Human AN
9. BLOCK HC30TS The measuring block contains all components counting chamber measuring tubes head draining tubes FIGURE 23 4 1 8 MEASURING BLOCK HC60TS The measuring block contains all components counting chambers measuring tubes HGB head draining tubes FIGURE 24 HumaCount 30TS 60TS Service manual MAIN MECHANIC AND FLUIDIC PARTS 31 4 1 9 PUMP Pump generates regulated vacuum and drains the fluidic system It is connected to the MAIN board and it has its own driver circuit Power FET In HC60TS there are two pumps The pump 15 maintenance free FIGURE 25 4 2 Assembled Analyzer 4 2 1 FRONT PANEL FIGURE 26 1 TFT display 2 Start button 3 USB socket 4 Sample holder Sample rotor Human 2 32 4 2 2 SIDE PANEL FIGURE 27 1 Cover screws 2 Cover screws 4 2 3 REAR PANEL HC30TS FIGURE 28 Cover screw Reagent inlets cover screw Power switch Cover screw USB A inlet USB B inlet Cover Screw A W N Grounding screw 10 12VDCpower IN 11 Cover screw HumaCount 30TS 60TS Service manual MAIN MECHANIC AND FLUIDIC PARTS 4 2 4 CONSTRUCTION FRONT O BP W 4 2 5 CONSTRUCTION SIDE 33 FIGURE 29 Main board Pump II only in HC60TS Vertical motor Pump Amplifier box Valves Dilutor motor Valves Sample Horizontal motor FIGURE 30 vv A U N on Q Valves 1 5 Micro dilutor Diluto
10. a mes sage when this volume reaches the preset tank capacity 5 1 Initialization of the Fluidic System Fluidic initialization process performs the following steps Checking of pump and pressure sensor by generating measuring vacuum Positioning all mechanical components by scanning moving range with end switches Priming of reagents Cleaning of tubing amp measuring chamber Cleaning of aperture with high pressure back flush cleaner reagent amp high voltage burning Human N 5 2 Operation of the fluidic system in HUMACOUNT 30 TS 5 2 1 FLOW DIAGRAM OF MEASUREMENT FIGURE 33 Chamber draining Fill up with 1ml diluent for WBC dilution Sampling process Needle washing Diluting process 1 160 Sampling process from primary dilution Needle washing Lysing process HumaCount 30TS 60TS Service manual OPERATION OF THE FLUIDIC SYSTEM 37 i FIGURE 34 Generating measuring Fill up with 1ml vacuum diluent for RBC dilution WBC counting process Dilution process 1 25600 measurement Needle washing Extensive cleaning Generating measuring vacuum Blank HGB measurement RBC measurement Draining l1 CRI Human N
11. components or connections Bad soldering salt residuals or component failure on amplifier especially if some reagent could get in the amplifier section Cleaning of PCB elec trode socket or replacement of amplifier is required Check for the correct soldering of reference cable and its connector Circuit board bad soldering or component failure Check the shielded cable connections as well Sometimes inside out connection hot electrode goes outside as a shield is the problem both ends of amplifier signal cable must be reversed Analog signal ribbon cable it picks up noise Check the ribbon cable between the circuit board and the amplifier Maybe it is pinched under some screws or components This may cause trouble and even noise 69 Human N 70 8 1 4 4 Pneumatic failures liquid paths that conduct noise into the chamber Liquid remains under the chamber in drain tube during measurement the conducting liquid remains inside the drain tube making noise to appear there Check chamber draining path for clogging or salt crystals Check the pump operation Since draining of the chamber goes under pressure control maybe a bad pressure sensor or connection can cause trouble e Clean the draining path Do not use alcohol but bleach Replace chamber if necessary Liquid remains in the washing inlet at top of the chamber during measure ment the conducting liquid remains inside the chamber wash tube making noise to appear
12. control Pump drains chamber while puffer reservoir and thus the pressure sensor is connected to the draining tube The instrument can detect the empty state of the chamber from drop of vacuum V4 DilNeedle 2 1 3 Pressure Meter Al V9 DilAperture L Puffer Reservoir Vend 2 X Micro dilutor V8 Bubble i E 53 V6 DrainChamber m Stepper Motor XE 2 way Valve WASTE Closed Off NP 4 3 Off 5 2 8 SHUTDOWN PROCESS v2 DilWash amp V3 DilChamber 3 Y Ino V5LyseWbc DILUENT 2 2N 11 X mE 2 eS o V10 DrainPuffer Sample FIGURE 40 V1 Cleaner CLEANER el H motor 3 way Open 2 3 The fluidic shutdown performs the following steps Priming chamber with reagent to avoid drying out of aperture Sampling needle is positioned above counting chamber needle up syringe are positioned up Diluent syringes are positioned up Sample rotor moved out Human N 44 5 3 Operation of the fluidic system in HC60TS The HC60TS fluidic system operates in two parallel pneumatic processes The first subsystem consists of the following components Microdilutor Diluent 1 dilutor V1 valve washing head Pump 2 This subsystem is marked with a dotted line outline in the charts The second subs
13. logged in as Service User Maintenance gt Calibration gt Service _ LL ks en T i d NI Histary Apply user factors E gx Factors In result calculations the service calibration factors used as the user calibration factors so they are multiplied for each parameter RBCDisp FactRBC User FactRBC Serv RBCMeasured If the user factor is near the bound 0 80 1 20 by setting the corresponding service factor the user factor can be adjusted to 1 00 using Apply user factors button Example Fact RBC User 1 19 and Fact RBC Serv 0 96 and Fact RBC User 1 00 and Fact RBC Serv 1 14 gives the same result for RBC fj Hij ET Delete Enter Press white data field to modify calibration factor A numeric input screen will show up so that you can enter values All values must be in the 0 8 1 2 range 10 ECH 1 00 100 ECH Press Accept to proceed with new settings or Cancel to keep values unchanged HumaCount 30TS 60TS Service manual ADJUSTMENTS History You can check the previous calibration factors with the date of change in atable form Apply L y s F factors lar P TT Apply user calibration factors function is used to combine user and service calibration factors The software will multiply the existing factors and move them to the Service level to set user factors t
14. measurement cycles 9 2 1 CHECK SELF TEST AND DEVICE STATISTICS Run the built in Self test and check the overall test result Check the device statistics to find common problems 9 2 2 CLEANING AND GREASING DILUTOR BLOCK The dilutor block driving wheels and gear bar should be cleaned from dirt and must be greased between the gear bar and the support and between cogged wheels 9 2 3 CHECKING AND LUBRICATING DILUTOR PISTON TIPS The cogged end of PTFE dilutor pistons should be cleaned and lubricated by neutral silicon grease Apply just a thin layer and move it along the perimeter of the piston so that some of the material goes into the gaps between the sealing rings HumaCount 30TS 60TS Service manual MAINTENANCE Repeat this step for lyse and dilutor pistons as well Check the condition of the micro piston sealing and replace if necessary 9 2 4 CHECKING AND REPLACING WASHING HEAD Check the state of the washing head and replace if necessary After replacing washing head do not forget to perform correct adjustment of sampling needle height see Section 4 1 2 9 2 5 BLEACHING OF FLUIDIC SYSTEM It is recommended to run a bleaching procedure to remove stains from the fluidic system 1 Connect 2 5 hand warm clean bleach solution to all reagent inputs and perform priming on all reagent inputs Leave it in the tubing for not more than 2 3 minutes Remove the bleach prime on air 4 Connect distilled water 100 ml and
15. perform priming all reagents again Connect reagents and run priming again Human N 14 A HumaCount 30TS 60TS Service manual APPENDICES 10 APPENDICES 10 1 Warning flags Analyzer SW displays warning flags for each individual measurement to notify user about status of results The following table summarizes warning flags and gives explanation of their possible cause and a few hints to overcome the problem Uppercase letters refer to WBC or HGB problems Flag Meaning WBC 3 part diffe rential HGB blank is high or no HGB blank B WBC blank is high or no WBC blank li it M inearity range excee ded in WBC stage RBC cells found in R sample during WBC stage W WBC 3 part warning Recommended user action Possible lyse problem May occur in pathological lymphocytosis Repeat the blank measurement blank 15 not stable there are probably bubbles in the WBC chamber Run a cleaning and try blank again Close the side door if open during measurement Repeat the blank measurement or run prime lyse and try blank again Possible lyse contamination or noise problem The analyzer found that the cell count is higher than the linearity range of the analyzer Make a pre dilution and run the same sample in predilut ed mode cells were detected during the WBC measurement Either the lyse reagent 15 not effective enough volume should be increased or the RBC s in the
16. reservoir 10 Pump 11 Valves 12 Tubing V4 DilNeedle 2 1 V5LyseWbc 1 X 2 3 Pressure Meter L Puffer Reservoir Lyse LYSE Macro Micro dilutor Dil V3 DilChamber SUN DILUENT 3 V9 DilAperture A gt RBC 5 wec SUN V8 Bubble gt V6 DrainChamber X lt V1 Cleaner N X V7 DrainAperture M Stepper Motor SE L 2 way Valve Closed Off NT Open CLEANER de er E X V10 DrainPuffer Sample H motor 3 way Valve 1 3 Off 2 3 23 FIGURE 16 HC 30TS fluidic schematic Human N 26 V2 DilNeedle 6075 fluidic schematic DILUENT Gre Reservoir T ure eMicro dilutor 2 way Valve INE IL Stepper Motor af y Valve Stepp Closed Off 2 i 1 3 2 3 WASTE 4 1 Single parts 4 1 1 SAMPLE HORIZONTAL AND VERTICAL MOTORS HC30TS and HC60TS Hematology Analyzers has a sample rotor for safety and Sample rotor is maintenance more precise sample handling Commonly used sample tubes are supported by e free replaceable tube adapters The Sample rotor unit uses a stepper motor connected to the MAIN board directly The rotor has opto s
17. 3 Setting the needle shaft 6 1 4 Setting the position of the chambers 6 2 HC30TS SPECIFIC ADJUSTMENTS 6 2 1 Setting the dilutor mechanics 6 2 2 Setting the horizontal movement 6 3 HC60TS SPECIFIC ADJUSTMENTS 6 3 1 Setting the dilutor mechanics 6 3 2 Setting the horizontal movement 31 31 32 32 33 33 35 35 36 38 39 40 41 42 43 43 44 45 46 47 48 49 50 50 51 51 51 51 52 53 54 54 54 55 55 55 CONTENTS 6 4 SERVICE CALIBRATION 6 5 SETTING RBC AMPLIFIER GAIN 6 6 SETTING WBC AMPLIFIER GAIN 1 CHECKIG THE PROPER OPERATION 7 1 SELF TEST 7 1 1 Self Test Screens 7 1 2 Normal range of Self Test parameters 7 1 3 Troubleshooting Guide for Self test 7 2 SERVICE MENU 7 2 1 Entering to Service Menu 7 2 2 Troubleshooting 7 23 Stress 7 2 4 Needle position check 7 2 5 Login as SERVICE User 8 SERVICE OPERATION 8 1 POSSIBLE CAUSES OF NOISE 8 1 1 Contaminated reagent 8 1 2 Bad earth grounding 8 1 3 External electrical noise 8 1 4 Internal noise sources 9 MAINTENANCE 9 1 WEEKLY USER MAINTENANCE 9 1 1 Cleaning needle washing head 9 2 PERIODIC MAINTENANCE BY SERVICE 9 2 1 Check Selftest and Device statistics 9 2 2 Cleaning and Greasing Dilutor Block 9 2 3 Checking and Lubricating Dilutor Piston Tips 9 2 4 Checking and Replacing Washing Head 9 2 5 Bleaching of Fluidic System 10 APPENDICES 10 1 WARNING FLAGS 10 2 USB B CONNECTOR COMMUNICATION 10 2 1 Characters and basic structure 10 2 2 Details ofthe 3 1 prot
18. 5 2 2 SAMPLING PROCESS The aspirating needle aspirates 25 uL 50 uL in prediluted mode of blood sam ple The Micro dilutor syringe makes the aspirating while the M3 Micro dilutor motor moves down The syringes are mechanically connected with a loose me chanism so there is a phase along the track where the micro dilutor doesn t move FIGURE 35 V4 DilNeedle gt lt V3 DilChamber V5 LyseWbe DILUENT 1 X 2 2NZAL Pressure V1 Cleaner Meter als a V9 DilAperture CLEANER Puffer Reservoir Macro Lyse L WBC i Micro dilutor V8 Bubble Dil HGB LYSE IX v7 DrainAperture An Ver V6 DrainChamber V10 DrainPuffer Sample H motor v 4 3 way m Stepper Motor SX 2 way Valve Valve Closed Off IS 4 3 off Open 2 3 There is also another sampling process for the second RBC dilution 25 of primary dilution is aspirated by the sampling needle from the chamber but it is kept in the sampling needle during the WBC measurement and the cleaning process HumaCount 30TS 60TS Service manual OPERATION OF THE FLUIDIC SYSTEM 5 2 3 NEEDLE WASHING PROCESS Both instruments clean the sampling needle with diluent in the washing head after sampling It is important to clean the outer surface of the sampling needle to avoid inaccurate sampling The Macro syringe doses and the pump drai
19. CE OPERATION 8 1 Possible Causes of Noise Generally high count of any particle even if you think it should be low or near zero can be caused by noise i e something interfere with the measurement The most important thing in these cases is to identify the source of the noise otherwise you cannot protect the system against it Noise can come from several sources and the different sources add up However only one of them may be enough to cause problems 8 1 1 CONTAMINATED REAGENT The most probable cause are particles in the reagent and therefore the PLT blank is continuously high e g always 30 40 You can easily sort out this case by replacing diluent with a new container PLT blank must go down during several blank measurements below 10 How can a good reagent become bad with time If the reagent tube was contaminated and some bacteria begin to grow inside once you put an infected reagent tube into a new tank by time it can become infected as well i e the background PLT blank becomes high Wash the reagent tube which is in connection with the reagent with 1 of bleach solution then rinse with clean distilled water or diluent It can avoid the bacteria to grow inside lf container is open and cap is not installed or closed external dust can fall into the reagent 8 1 2 BAD EARTH GROUNDING In this case external ground referenced noise can get into the system by ground coupling If system ground is no
20. Draining connection FIGURE 4 Measuring tube ao W N Complete measuring tube O rings Reference electrode U shaped metal fixing Aperture Measuring tube with aper ture 70 80 100um Human 2 FIGURE 5 HGB measuring head 1 LED 2 Connectionto the amplifier 3 TSL235 Due to enhanced HGB tech e nology HC30TS HC60TS is less sensitive to incident light changes However it is recom mended to keep side door closed during measurements 3 1 2 HGB MEASURING HEAD Hemoglobin head 15 placed around one measuring chamber in all instruments It contains light source LED at 540 nm wavelength and Photo Detector TSL235 The Photo Detector converts the light to frequency The HGB concentration is a logarithmic function of this frequency measured by the FPGA circuit of the MAIN board The analyzer performs enhanced hemoglobin measurement technology for HGB measurement The frequency output signal of TSL235 is counted by a digital counter in the FPGA circuit This counter counts up while the LED is on and counts down while the LED is off The LED and direction of counting are switched with a 100 Hz signal This method provides real time backlight correction which makes the HGB measurement more precise in changing backlight environment situation as well There are two kinds of HGB measurement Sample measurement before RBC counting Diluent blank measurement in WBC washing phase The HGB result is
21. HUMAN representative shall be relieved of any liability under this warranty if the product is not used in accordance with the manufacturer s instructions altered in any way not specified by HUMAN not regularly maintained used with equipment not approved by HUMAN or used for purposes for which it was not designed HUMAN shall be relieved of any obligation under this warranty unless a completed installation warranty registration form is received by HUMAN within 15 days of installation of this product This warranty does not apply to damages incurred in shipment of goods Any da mage so incurred shall be reported to the freight carrier for settlement or claim equipment not approved by Human or used for purposes for which it was not designed Human shall be relieved of any obligation under this warranty unless a com pleted installation warranty registration form is received by Human within 15 days of installation of this product Human N IVD This warranty does not apply to damages incurred in shipment of goods Any damage so incurred shall be reported to the freight carrier for settlement or claim 1 3 Intended Use of the Instrument The instrument is intended for in vitro diagnostic application by professional users It has to be used for the expected purposes and in perfect technical conditions by qualified personnel in working conditions and maintenance operations as described in this manual according to the GENERAL SAFET
22. HumaCount 30 and 60 Service Manual 16420 302 Human Diagnestics Worldwide REVISION LIST OF THE MANUAL Rev DATE REVISION DESCRIPTION 01 2010 09 First edition SYSTEM VERSION HumaCount 60 and HumaCount 305with software version 1 2 COPYRIGHT Copyright 2010 Human GmbH Wiesbaden Germany All rights reserved No part of this documentation may be reproduced in any form nor processed copied or distributed by means of electronic systems without prior permission of Human GmbH in writing Since all precautionary measures were taken into account in producing these operating instructions the manufacturer accepts no responsibility for any errors or omissions This includes any liability for damage that could arise from possible incorrect operation based on this information Subject to changes without notice as result of technical development SERVICE UND SUPPORT CONTENTS TABLE OF CONTENTS 1 SAFETY INSTRUCTIONS 1 1 INTRODUCTION 1 2 USER WARRANTY 1 3 INTENDED USE OF THE INSTRUMENT 1 4 GENERAL SAFETY WARNINGS 1 5 DISPOSAL MANAGEMENT CONCEPT 1 6 INSTRUMENT DISINFECTION 1 7 BIOHAZARD WARNING 2 INTRODUCTION 2 1 NAME AND SERIAL NUMBER 2 2 INTEGRATED SOFTWARE 3 FUNCTIONAL DESCRIPTION 3 1 MAIN ELECTRONIC PARTS OF THE ANALYZERS 2d 3 1 2 331 9 3 1 4 3 13 3 1 6 3 1 4 3 46 01 Counting chamber with electrodes and measuring aperture HGB Measuring Head Cell Counter Amplifier Board HC30TS Cell Co
23. TTING THE DILUTOR MECHANICS The micro dilutor s movement must be set bythe following procedure 1 Pushthe dilutor pistons up as possible 2 Fastenthe set screw of the upper fixing ring 3 Fasten the lower fixing ring s set screw in the position shown in picture on the left a Li E Ld n pte AIT 6 he DB T a Ar Is Fl Bra i 6 2 2 SETTING THE HORIZONTAL MOVEMENT The setting of the horizontal movement is correct when the opto wheel is in the position shown in the picture then the aspirating needle bracket is as close to the cantilever as possible HumaCount 30TS 60TS Service manual ADJUSTMENTS 55 6 3 HC60TS specific adjustments 6 3 1 SETTING THE DILUTOR MECHANICS The micro dilutor s movement must be set by the following procedure 1 Push the dilutor pistons up as possible 2 Fasten the set screw of the upper fixing ring 3 Fasten the lower fixing ring s set screw in the position shown in picture on the left FIGURE 55 6 3 2 SETTING THE HORIZONTAL MOVEMENT The setting of the horizontal movement is correct when the opto wheel is in the position shown in left picture then the aspirating needle bracket is as close to the cantilever as possible FIGURE 56 Human JNE 6 4 Service Calibration The analyzer provides a menu for Service calibration purposes acs O History You can access the service calibration menu
24. Y WARNINGS This manual contains instructions for professional qualified operators HumaCount 30 HumaCount 60 hematology analyzers are fully auto mated cell counters for in vitro diagnostic use The compact instruments were developed for small clinics point of cares and hospitals HumaCount 30 can process 30 HumaCount 60 can process 60 samples per hour and they are intended to determine the following 18 hematology parameters from a 25uL whole blood sample WBC LYM GRA LYM MON GRA 6 three part WBC differential RBC MCV RDW MCHC PLT MPV PCT 1 4 General Safety Warnings Use only chemical reagents and accessories specified and supplied by HU MAN and or mentioned in this manual Place the product so that it has proper ventilation The instrument should be installed on a stationary flat working surface free from vibrations Do not operate in area with excessive dust Work at room temperature and humidity according to the specifications listed in this manual Do not operate this instrument with covers and panels removed Only use the power cord specified for this product with the grounding conductor of the power cord connected to earth ground Use only the fuse type and rating specified by the manufacturer for this instru ment use of fuses with improper ratings may pose electrical and fire hazards To avoid fire or shock hazard observe all ratings
25. ad Amplifier board includes a 3 stage main amplifier channel which gains input signal to the 0 3 3 V range this is the input range of the A D converter on the Main board The RSW signal with Q8 transistor changes the input electrode through REL2 relay The bottom side of the amplifier board contains special connectors for the electrodes and the HGB head JP2 DHON signal from the MAIN board switches on with Q4 the LED and the PLS signal switches off the Photo Detector in the HGB head to prevent noise generated by the HGB detector HumaCount 30TS 60TS Service manual FUNCTIONAL DESCRIPTION 3 1 5 MAIN CPU BOARD This board contains DIMM PC and measurement processing unit 4 motor controllers valve amp pneumatic controller drivers pump driver s power supply for internal printer 7 5V and digital circuitry 5V 3 3V MAIN board is responsible to control the instrument contains the main power regulator circuits valve and motor driver circuits and other connections for the fluidic and pneumatic system s parts responsible for the specific measurement processing functions The central micro controller with a FPGA and with several other digital chips buffers decoder multiplexer handles the pneumatic system displaying measurement and data management Power system filtering the 12V Input and generates 3 3V FPGA 5V Digital power 7 5V Printer power Filtered 12V is used for the po
26. ample which is in the sampling needle In the first diluting step the sample is dispensed into the measuring chamber with 3 ml of diluent which comes from the Macro syringe through V4 On and Micro dilutor while the M3 Dilutor motor moves upwards This ME DILUENT NP Pressure process makes the 1 160 first dilution rate in the chamber FIGURE 37 V2 DilWash 57 V4 DilNeedle XT va DilChamber V5LyseWbc V1 m 3 V9 DilAperture Le Joueaner Macro Micro dilutor Dil 3 e V10 DrainPuffer Sample H motor v iN A2 97W8y M Stepper Motor x 2 way Valve ae Valve Closed Off 1 3 Off Open On 2 3 The second sample 25 uL of primary dilution is stored the sampling needle during the WBC measurement and the cleaning process The instrument makes the second RBC dilution into the chamber after these processes HumaCount 30TS 60TS Service manual OPERATION OF THE FLUIDIC SYSTEM 41 5 2 5 LYSING PROCESS In this step the set lysing reagent is added into the measuring chamber through V5 On while the Lyse syringe moves upwards This process makes the WBC HGB dilution with lyse reagent V2 DilWash Ez V4 DilNeedle gt 2 2X nn gt DilChamber av 1 2 X Pressure Puffer Reservoir Lyse LYSE FIGURE 38 DILUENT
27. and markings on the instrument HumaCount 30TS 60TS Service manual SAFETY INSTRUCTIONS Do not power the instrument in potentially explosive environment or at risk of fire Prior to cleaning and or maintaining the instrument switch off the instrument and remove the power cord For cleaning use only materials specified in this manual otherwise parts may become damaged It is recommended always to wear protective apparel and eye protection while using this instrument Respective warning symbols if appearing in this manual should be carefully considered 1 5 Disposal Management Concept The currently valid local regulations governing disposal must be observed It is in the responsibility of the user to arrange proper disposal of the individual components All parts which may comprise potentially infectious materials have to be disinfected by suitable validated procedures autoclaving chemical treatment prior to disposal Applicable local regulations for disposal have to be carefully observed The instruments and electronic accessories without batteries power packs etc must be disposed off according to the regulations for the disposal of electronic components Batteries power packs and similar power source have to be dismounted from electric electronic parts and disposed off in accordance with applicable local regulations 1 6 Instrument Disinfection Analytical instruments for in vitro diagnostic involve the handling of huma
28. applying neutral silicon grease to the cogged end of the Macro and Lyse pistons between the syringe and the tip itself This will ensure optimum sealing and longer lifetime of piston tips Greasing of the cogged trans mission parts cogwheel and cogged bar should be done regularly using machine grease It is recommended to check and repeat greasing of piston tips and transmission gear every year or after 10000 measurements 4 1 5 DILUTOR BLOCK HC30TS In HC30TS this unit includes one dilutor stepper motor The Micro dilutor syringe makes the aspirating while the motor moves down The syringes are mechanically connected with a loose mechanism so there is a phase along the track where the micro dilutor doesn t move HumaCount 30TS 60TS Service manual MAIN MECHANIC AND FLUIDIC PARTS 4 1 6 DILUTOR BLOCK HC60TS mi In HC60TS this unit includes two dilutor channels one for diluent and sampling and another one for lyse and diluent reagents There are two stepper motors 4 opto sensors five syringes and piston rods with gear transmission The Micro dilutor syringe makes the aspirating while the motor moves down The syringes are mechanically connected with a loose mechanism so there is a phase along the track where the micro dilutor doesn t move 29 FIGURE 22 ao W N Micro dilutor Diluent 1 syringe Positioners Positioners Lyse syringe Diluent 2 syringes Human 2 4 1 7 MEASURING
29. calculated from these measurements by HGB log CNT CNT diluent light sample M 3 1 3 CELL COUNTER AMPLIFIER BOARD HC30TS Amplifier board includes its own voltage regulator connection interfaces to HGB head and to MAIN board There is a current generator circuit on it which works from 50V measuring voltage generated by MAIN and the probe voltage DC is amplified with a voltage follower output ELV Nominal measuring current is 870 uA Amplifier board includes one input connector for the chamber measuring electrode There are two opto switches U1 U3 to connect high voltage to the probe with HSW signal and isolate the input of the amplifier Test circuit makes possible to generate test pulses with TEST and PLS signals through FETs for checking the proper operation of the amplifier channel HumaCount 30TS 60TS Service manual FUNCTIONAL DESCRIPTION PEE hel a tO SED e I Lux 1 EA i TT y UR Zea xe o AVES nul Amplifier board includes a 3 stage main amplifier channel which gains inpu signal to the 0 3 3 V range this is the input range of the A D converter which is placed on the MAIN board The RSW signal changes the gain RBC WBC in he feedback of the second amplifier stage with U2 MAX319 analog switch Amplifier gain and offset are adjusted by software DHON signal switches on the LED and the MVON signal which is active during counting switches off the Photo Detector in th
30. e HGB head to prevent noise generated by the HGB detector he other side of the amplifier board contains special connectors for the cham ber and the HGB head JP4 3 1 4 CELL COUNTER AMPLIFIER BOARD HC60TS Amplifier board includes its own voltage regulators connection interfaces to HGB head to chamber electrodes high voltage and DIGIO connector to Main board There is a current generator circuit on this board which works from 50V measuring voltage generated by the High Voltage Circuit on Main board and the probe voltage DC is amplified with a voltage follower output ELV Nominal measuring current is 870 uA Amplifier board includes one input connector for each measuring chambe measuring electrodes There is one opto switch OPT1 and a relay REL1 to connect high voltage to one of the probes with HSW signal and to isolate the input of the amplifier Test circuit allows generating test pulses with TEST and PLS signals through O1 O2 FETs for checking proper operation of each amplifie channel FIGURE 6 Cell counter amplifier board 1 Connection to HVB on Main 2 Connection to CSA1 on Main 3 Connection to DIGIO on Main Human NE FIGURE 7 Cell counter amplifier board front side 1 Connection to Main board HVB 2 Connection to Main board DIGIO 3 Connection to Main board amplifier in FIGURE 8 Cell counter amplifier board back side 1 Connection to the electrodes 2 Connection to HGB he
31. e user settings The software version number can be read out from the Device Information or from the Self test submenu Every HC30TS HC60TS software version is upgradeable using an USB flash drive by the latest program developed by HUMAN and it can be downloaded from http www human de Human N A HumaCount 30TS 60TS Service manual FUNCTIONAL DESCRIPTION B 3 FUNCTIONAL DESCRIPTION 3 1 Main electronic parts of the analyzers HC30P HC60P contain the following electronic parts 1 Counting chamber 2 pcs in HC60TS with electrodes and measuring aperture HGB Measuring Head Cell Counter Amplifier Board MAIN CPU Board with Dimm PC and measurement processing unit 4 motor controllers valve amp pneumatic controller driver pump driver and power supply for internal printer 7 5V and digital circuitry 5V 3 3V DIMM PC module Motors with opto boards of needle moving motor H and sample rotor needle moving motor V Dilutor block with opto board for sampling diluent lyse and cleaner Valve boards set of 5 and max 7 Peristaltic Pump 2 pcs in HC60TS 10 USB interface 11 Graphic LCD Display Module with touch screen 12 Start Button Panel 13 Internal Printer Ser gt o du Human N l4 IAS quassy Aejdsiq S L090H 0 LA 1059 FEA oIpin 4 FIGURE 2 Block diag
32. ed parameter value exactly 4 characters number with a possible decimal dot padded with spaces on the left side or 4 minus signs or 4 spaces unit is at most 4 characters long possible values are 4 10 L 107 110 L 109 UE 17 967 g L g dL mmol L pg fmol depending on the parameter Min and max are the lower and upper bounds of the normal range exactly 4 characters including a possible decimal dot padded with spaces on the left side flags is a series of characters indicating errors at most 32 characters long upper or lowercase letters to 2 always the same indicates the beginning of the WBC histo gram wbcscale is maximum 3 digit number indicating the fl value of the last channel value is usually 400 HumaCount 30TS 60TS Service manual APPENDICES Channels lt HT gt wbcchannels WMarker1 HT wm1 WMarker2 HT wm2 WMarker3 HT wm3 79 wbcchannels is the number of channels columns in the histogram always 256 wm1 is the first WBC discriminator channel RBC WBC wm2 is the second WBC discriminator channel LYM MON wm3 is the third WBC discriminator channel MON NEU chxx is the histogram height at a given channel range Points lt HT gt ch0 lt HT gt lt HT gt ch2550 255 there are always wbcchannels values here usually RBC graph Scale fl lt HT gt rbcscale Channels HT rbcchannels RMarker1 HT rm1 256 always the same indica
33. ensors for positioning E FIGURE 18 Sample probe motors 1 Vertical motor 1 2 Sample Horizontal motor not visible HumaCount 30TS 60TS Service manual MAIN MECHANIC AND FLUIDIC PARTS 4 1 2 SAMPLING NEEDLE Sampling needle is assembled in the H amp V moving unit and it makes the sample aspirations Correct setting of sampling needle is necessary and very important see Chapter Adjustments 4 1 3 NEEDLE WASHING HEAD Washing head is located at the bottom of the H amp V moving unit and it is for cleaning the outer surface of the sampling needle This washing process is made with diluent reagent and the fluid is drained by the pump The arrows on the picture show the direction of diluent flow during sampling needle washing 4 1 4 PUFFER RESERVOIR The glass puffer reservoir is directly connected to the pressure sensor During measurement there is no pump activity so the puffer reservoir maintains measuring vacuum stable The instrument measures relative pressure so measuring vacuum 15 independent of atmospheric pressure 27 Clean or replace washing head e yearly or after 10 000 mea surements FIGURE 19 Needle washing head 1 Clean diluent 2 Pump to waste FIGURE 20 Puffer reservoir Human 28 FIGURE 21 Micro dilutor Positioners Positioners Pistons Pistons Diluent syringe NO A U N Lyse syringe Maintenance should e vided to the piston tips by
34. es while HC60TS has 6 valves in Valve board 6 12 module The valve boards are connected to controller and driver chips which are located on the MAIN board 3 1 9 TFT DISPLAY AND START BUTTON BOARD 23 FIGURE 13 Valve assembly 1 Valves 2 Valve Board 3 Connection to Main board FIGURE 14 Front panel connections 1 Touchscreen connector 2 Start button amp status LED connector 3 Ribbon cable from TFT Touch board to Main board 4 TFT connector to Main board 5 TFT Backlight connector 6 Ribbon cable from TFT Touch board to Main board Human 2 24 3 1 10 EXTERNAL POWER SUPPLY The analyzer works with an external power supply The figure below shows the power supply unit generating 12VDC The power supply modules have an auto range input which makes possible to use them with 230V 115V mains outlet and it has the CE and UL safety certificate The input socket of the power supply is a standard 3 terminal plug with power cable connection the output is a coaxial power connector FIGURE 15 Power supply 1 230 AC inlet 2 12V DC outlet HumaCount 30TS 60TS Service manual MAIN MECHANIC AND FLUIDIC PARTS 4 MAIN MECHANIC AND FLUIDIC PARTS HC30TS and HC60TS Hematology Analyzers consist of the following mechanic and fluidic parts 1 Sample rotor 2 Sampling needle 3 Washing head 4 Sample Horizontal moving unit 5 Micro Dilutor 6 Dilutor 7 Chamber 8 Cell counter probe 9 Puffer
35. es the cleaner through the V3 On V10 On V7 On valves to puffer the cleaner reagent in the tubes between V10 and V3 V1 DilWash 4 amp gt 9 EG aX V4 DilChamber P WA Puffer Reservoir Lt LN GLEANER EVA V5 LyseWBC 1 2 NI a 1 t3 Sample H motor m oe lt 3 way Stepper Motor SX 2 way Valve TU Valve Closed 1 3 Off WASTE Open On 2 3 After that the Diluent 2 syringes pushes the cleaner reagent remaining in the tube between V10 and V3 into the chamber 5 3 7 SHUTDOWN PROCESS The fluidic shutdown performs a fluidic system cleaning with cleaner HumaCount 30TS 60TS Service manual ADJUSTMENTS 51 6 ADJUSTMENTS The adjustments below are made in the factory Readjustment of following parts is necessary if some components are replaced 6 1 Common adjustments 6 1 1 VERTICAL MOVEMENT SETTING TIMING BELT TENSION The timing belt tension could be set with positioning the vertical motor using the oval holes in the mounting plate FIGURE 48 6 1 2 VERTICAL OPTO SENSOR AND NEEDLE SETTINGS The vertical opto sensor should be set as follows FIGURE 49 ES 1 o
36. ex OxFF to it and keeping only the last two hexadecimal digits The last character of a record is always the single control character End of Transmission lt EOT gt 4 0x04 There is no terminating NULL lt NUL gt 0 0x00 character at the end The next record can start right after the lt EOT gt character 10 2 2 DETAILS OF THE 3 1 PROTOCOL The body of a transmission is line oriented separated by the two byte Carriage Return Line Feed lt CR gt lt LF gt 13 10 OxOD sequence A single line might contain one or more fields separated by the Horizontal tab lt HT gt 9 0x09 character The following lines are usually composed of an identifier field and one or more value fields all separated by the HT character The characters in bold ap pear in the transmission exactly as written without any variance between re cords Control characters are marked with the and characters for example HT Comments are marked with and and are not included in the actual Human 18 transmission For a more detailed discussion on the meanings of the various parameters and histograms please refer to the instruments user manuals TABLE 5 1 to header 8 Serial No lt HT gt serial RecNo lt HT gt recno Sample ID lt HT gt sampleid Patient ID lt HT gt patientid Patient Name lt HT gt patientname Mode lt HT gt mode Doctor lt HT gt doctor Age lt HT gt value
37. fset Amplifier Noise test during a 5 second period Amplifier transfer by generating 20000 test pulses incl gain related peak value noise related deviation Vacuum reports pump operation vacuum made by the pump in a 10 second period of time Drift represents pressure loss of vacuum measured in a 10 second period of time Fast blank meas the device performs a fast blank measurement This number is the PLT count Probe min probe max probe voltage are relative numbers during fast blank measurement Human 2 60 TABLE 1 TABLE 2 7 1 2 NORMAL RANGE OF SELF TEST PARAMETERS Parameter HGB light Electrode voltage Current Offset Amplifier test Peak of test pulses deviation noise Noise test Vacuum Drift Fast blank meas Fast blank probe min Fast blank probe max 7 1 3 TROUBLESHOOTING GUIDE FOR SELF TEST Parameter HGB dark HGB light Electrode voltage Current Offset Amplifier test Mark HIGH LOW HIGH LOW or HIGH LOW or HIGH LOW or HIGH LOW HIGH Unit Lower bound Upper bound count 3000 60000 V 45 55 830 930 mV 5 0 5 0 count 19990 20050 mV 1300 1700 mV 0 100 pls 5sec 0 50 mBar 300 600 mBar 10sec 0 10 count 0 100 5 280 360 280 360 Possible reason Remedy Instrument door open HGB head not connected or HGB LED out of order Instrument door open or HGB LED too bright Fault on MAIN or Amplifier board Fault on Amplifier board Fault
38. hannel PLT RBC chxx is the histogram height at a given channel range Points HT chO HT HT ch2550 255 there are always pltchannels values here usually 256 As mentioned above after the last channel value in the PLT histogram the body of the record is closed with the control character End of Text lt ETX gt 3 0x03 Human N 80 10 3 Cabling diagram FIGURE 59 HC30TS cabling diagram motor right 3 13 15 Vires rr nH HumaCount 30TS 60TS Service manual APPENDICES P FIGURE 60 HC60P cabling scheme Internal printer Sample rotor Horizontal E movement aptosansors 2585 Plutar Vertical optesensor 13 15 tekja VA Human 2 82 10 4 Tubing schematics FIGURE 61 MAIN Board 2 Pressure Tubing schematics HC30TS Sensor ys j ENS N N HumaCount 30TS 60TS Service manual APPENDICES 83 MAIN Board FIGURE 62 Pressure Sensor Tubing schematics HC60TS Human N 84 10 5 Recommended kit of tools Screwdrivers Cross Slot Screwdrivers Philips Slot Screwdrivers Hexagon Screwdrivers 3 5 2 5 2 0 1 5 mm sizes Pocket digital multimeter Diagonal Cutter plier Nipper HumaCount 30TS 60TS Service manual APPENDICES 85 Human 2 Gesellschaft fur Biochemica und Diagnostica mbH Max Planck Ring 21 65205 Wiesbaden Germany Tel 49 6122
39. lt HT gt unit Birthlymd lt HT gt birthdate Sex lt HT gt gender Test date ymd lt HT gt date Test time hm lt HT gt time Param lt HT gt Flags lt HT gt Value lt HT gt Unit HT min max param lt HT gt flag lt HT gt value lt HT gt unit HT min max Flags HT flags WBC graph Scale fl HT wbcscale header1 to header8 are the lab header lines these lines are defined by the user in the instrument settings any or all of these lines can be empt serial is the 6 digit serial number of the instrument recno is the internal record number at most 6 digits sampleid is at most 8 characters long patientid is at most 20 characters long patinetname is at most 32 characters long doctor is at maximum 16 characters long value is a number of at most 3 digits unit is either years or months birthdate is an 8 digit number format gender is Male Female Neutered Spayed or a single character date 15 8 digit number format yyyymmdd time is a 6 digit number format hhmmss this is a header line always the same There are 24 similar lines param is the parameter name at most four characters long possible values are in sequence WBC RBC HGB HCT MCV MCHC PLT PCT MPV PDWs PDWc RDWs RDWc LYM MON NEU LY MO EOS EO 6 BAS BA flag is a single character indicator can be space E and asterisk value is the measur
40. n samples and controls which should be considered at least potentially infectious Therefore every part and accessory of the respective instrument which may have come into contact with such samples must equally be considered as potentially infectious Before doing any servicing on the instrument it is very important to thoroughly disinfect all possibly contaminated parts Before the instrument is removed from the laboratory for disposal or servicing it must be decontaminated Decontamination should be performed by authorised well trained personnel only observing all necessary safety precautions Instruments to be returned have to be accompanied by a decontamination certificate completed by the responsible laboratory manager If a decontamination certificate is not Human N FIGURE 1 Biological Hazard Symbol supplied the returning laboratory will be responsible for charges resulting from non acceptance of the instrument the servicing centre or from authority s interventions 1 7 Biohazard warning Analytical instruments for in vitro diagnostic application involve the handling of human samples and controls which should be considered at least potentially infectious Therefore every part and accessory of the respective instrument which may have come into contact with such samples must equally be considered as potentially infectious For safety reasons we have labeled instruments with the BIOHAZARD warning label below
41. n detect any kind of noise or bubbles in the system if the PLT is not stable low or HGB has big variation To exit from this mode press the Abort button at the end of a normal cycle until the Stress operation is finished 7 2 4 NEEDLE POSITION CHECK The service personal can check the correct needle setting touching Needle position check button If the needle opto is set correctly then after the button touch the needle lower end is co planar with the bottom plane of the washing head If it doesn t then adjust the needle opto up or down and check the position again 7 2 5 LOG IN AS SERVICE USER Certain service functions are accessible only for the SERVICE user In Main menu touch Exit button Hurnacount Measure Database Maintenance Settings If you are logged in as different user touch Logout USERNAME and then the Log In button else touch Log In button Logout Admin O Preparing shipment User Management HumaCount 30TS 60TS Service manual CHECKIG THE PROPER OPERATION 65 Log In Shutdown Preparing for shipment Service At Log In screen Press the START button on front panel so the Login Name will change to Service Touch Password empty field Type in the Service User password which is 6484 then touch Enter button Touch Accept button on Log In screen Human 2 66 A HumaCount 30TS 60TS Service manual SERVICE OPERATION 8 SERVI
42. nd Start Button Connectors to Amplifiers Internal battery Power Connector Power Switch Connector USB B Type Interface USB A Type Interfaces Connectors to Optos Pump Connector 1 Pump Connector 2 HC60TS Only Valves Connector Human 2 22 3 1 6 DIMM PC MODULE The MAIN board incorporates a credit card sized PC named Dimm PC The processor on the Dimm PC is a 133MHz Pentium class core with 32Mbytes on board RAM and 32Mbytes on board flash This is the SSD Solid State Disk of the analyzer so instrument software with all user settings calibration data base etc is stored on the Dimm PC DimmPC is the Trade Mark of Kontron Embedded Modules GmbH FIGURE 11 DIMM PC o _ 2 5 E EE ee p 2 j In bk I Flash BIOS 32 Mbytes RAM CMOS EEPROM On board SMPS Edge connector AMD Elan SC520 CPU Super I O Realtime clock ALIE TTE E i A 550 controller SSD IT HER I 3 1 7 SENSORS Opto sensor snap in modules are responsible for checking motor positions There are 6 opto sensors in HC60TS and 5 in HC30TS see cabling diagram FIGURE 12 Opto sensor HumaCount 30TS 60TS Service manual FUNCTIONAL DESCRIPTION 3 1 8 VALVE BOARDS There are two kinds of valve boards Valve board 1 5 and Valve board 6 12 HC30TS has 5 valv
43. ns the diluent from the washing head while sampling needle moves upwards so that the total length of it is washed and cleaned This process is called total sampling needle washing and itis mainly used after taking primary sample from sample tube Another process which is washing only a smaller part of the sampling needle is the same but the needle does not move in the total length Some procedures perform this kind of sampling needle washing v2 DilWash J VA DilNeedle SAX lt V3 DilChamber 3 Y V5LyseWbc 1 N 2 2 D NI Pressure V1 Cleaner Meter Al 5 mE NZ V9 DilAperture L Puffer Reservoir Macro Lyse AR SUN Micro dilutor ii V8 Bubble i LYSE DILUENT CLEANER 14 mmm mmi V10DrainPuffer Sample motor Po 3 way AXE 2 way Valve X vave NT Open 2 3 On ai Stepper Motor The Macro syringe pushes the diluent through V4 Off V3 Off V2 On The Pump aspirates the diluent from the washing head through V10 On while the M2 Vertical motor moves the sampling needle up FIGURE 36 Human N 40 5 2 4 DILUTING PROCESS The parts ofthe fluidics are rinsed with diluent reagent The measuring chamber is filled up with 1 ml of diluent This method prevents the chamber from dirt and makes the diluting process faster The sampling process has aspirated 25 uL of s
44. o 1 00 6 5 Setting RBC amplifier gain If the correct MCV value cannot be obtained by calibration the amplifier gain of RBC measurement could be increased or decreased by approx 10 Please be advised that changing this value requires to recalibrate the device to get proper results The settings are under Settings gt Measurement gt Setting gt Calibration Calibration WBC gain adjust REC gain adjust nm Accept Cancel 57 Human JNE 6 6 Setting WBC amplifier gain If the WBC diagram is shifted too far on left or right in WBC histogram the amplifier gain of WBC measurement could be increased or decreased by approx 10 Please be advised that changing this value requires to recalibrate the device to get proper results The settings are under Settings gt Measurement gt Settings gt Calibration HumaCount 30TS 60TS Service manual CHECKIG THE PROPER OPERATION 59 1 CHECKIG THE PROPER OPERATION 7 1 SelfTest There is a built in Self test and Service menu in each model Self test can be used to check the operation of the instrument The test results can be printed or saved to USB flash disk With the Retry button the self test is repeated 7 1 1 SELF TEST SCREENS Every measured value has a check mark if it is in the acceptable range or a X and a minus or plus sign if it is below or above the normal range HGB measured impulses per second Measuring Electrode voltage current and of
45. ocol 56 57 58 59 59 59 60 60 61 61 62 63 64 64 67 67 67 67 68 68 71 71 71 72 72 72 72 73 73 75 75 76 77 77 10 3 CABLING DIAGRAM 10 4 TUBING SCHEMATICS 10 5 RECOMMENDED KIT OF TOOLS 80 82 84 SAFETY INSTRUCTIONS 1 SAFETY INSTRUCTIONS 1 1 Introduction This manual s considered as a part of the instrument it has to be at the operators hand as well as at the maintenance operator s availability For accurate installation use and maintenance please read the following instructions carefully In order to avoid instrument damage or personal injury carefully read the GENERAL SAFETY WARNINGS describing the suitable operating procedures In case of breakdowns or any troubles with the instrument apply to the local Technical Service 1 2 User Warranty HUMAN warrants that instruments sold by one of its authorised representa tives shall be free of any defect in material or workmanship provided that this warranty shall apply only to defects which become apparent within one year from the date of delivery of the new instrument to the purchaser The HUMAN representative shall replace or repair any defective item at no char ge except for transportation expenses to the point of repair This warranty excludes the HUMAN representative from liability to replace any item considered as expendable in the course of normal usage e g lamps valves syringes glassware fuses diskettes tubing etc The
46. ode Multiple or incorrect RBC peak s detected Try to run the sample again PLT and RBC cells could not be separated or the histogram remained high in the PLT RBC valley range k RBC peak error PLT RBC limit not correct C RBC PLT clogging The same action as in case of the C warning flag Run cleaning and repeat the blank measurement PLT blank is high Diluent or system cleanliness problem If it is sta or no PLT blank ble high replace the diluent by opening a new tank RBC blank is high or no blank Same action as in case of warning flag 10 2 USB B connector communication The byte stream 15 a human readable ASCII character stream with occasional control characters Most programming environments are able to handle this stream as a simple ASCII string or text The stream is line oriented with special characters to separate fields The protocol has a single format for transmitting a single measurement record more records are sent they are simply chained together one after the other HumaCount 30TS 60TS Service manual APPENDICES 10 2 1 CHARACTERS AND BASIC STRUCTURE The byte stream uses the ASCII characters in the range 1 255 http en wikipedia org Ascii or Ox01 0xFF in hexadecimal A record transmission consists of three parts a small header a big text body and small footer single record is never longer than 8192 bytes A transmission always starts with the control cha
47. of blood sam ple The Micro dilutor syringe makes the aspirating while the M3 Micro dilutor motor moves down The syringes are mechanically connected with a loose me chanism so there is a phase along the track where the micro dilutor doesn t move r 0 FIGURE 42 V2 DilNeedle V1 DilWash i Cleaner DILUENT Reservoir xX L 1 V5 A vio N cLeANeR Diluent Diluen Lyse L Bubble d Micro dilutor 4 LYSE je 5 aD women Din Drainchamber 5 EE Vi bana H 4 Sample M 2 0 Lu ce Pump 1 ump zn CZ mm on Stepper Motor XE du Fins T WASTE Spat sen 2 3 On The second sample 35 uL of primary dilution is made in the RBC chamber The instrument makes the second RBC dilution into the chamber after straight after the WBC dilution Human N 46 FIGURE 43 5 3 2 DILUTING PROCESS The parts ofthe fluidics are rinsed with diluent reagent The measuring chamber is filled up with
48. on Amplifier board Amplifier Boards is not connected to main board Close instrument door Check HGB head connections Check HGB LED during measurement Close door or replace HGB LED resistor on amplifier board Check measuring voltage SOV on High voltage and Amplifier boards Check current generator and test generator FET on Amplifier board Check the offset poten tiometer on Amplifier board Check cables and connectors coming from the Amplifier Instrument not grounded Check mains ground lead HumaCount 30TS 60TS Service manual CHECKIG THE PROPER OPERATION Check current generator LOW or Peak of pulses Fault on Amplifier board and test generator FET on HIGH p Amplifier board Inst t not Dev noise HIGH o M Check mains ground lead grounded Inst t not Noise HIGH Check mains ground lead grounded Vacuum LOW Peristalticpump failure Check peristalticpump Check tubing i Drift HIGH Leakage in pneumatics nn pneumatics Fast Blank n an HIGH Contaminated system Run cleaning cycle Check measuring voltage 50V on MAIN and Am plifier boards Check measuring voltage 50V on MAIN and Amplifier boards Fast Blank HIGH or Fault on MAIN or probe min LOW Amplifier board Fast Blank HIGH or Fault on MAIN or probe max LOW Amplifier board 7 2 Service Menu 7 2 1 ENTERING TO SERVICE MENU There is a Service menu for servicing and operation checking purposes The entry point is in Maintenance g
49. pto sensor 2 flag The flag 1 mounted on the vertical needle moving mechanism must run freely between the two parts 2 of the opto sensor Human SION 52 The vertical position can be set loosening the two mounting screws of the opto sensor and moving it up or down In the correct setting the end of the needle is coplanar of the lower plane of needle cleaner unit The opto sensor state could be checked in the software see chapter 8 2 4 FIGURE 50 Oval holes for setting the vertical position of opto sensor E e End of needle is coplanar with the lower plone of mide cleaner ri 6 1 3 SETTING THE NEEDLE SHAFT The needle shaft must be fastened If it was loose it could be adjusted with the set screw on top end of the shaft Sek screw for FIGURE 51 minknizing the vertical movement of shaft zz HumaCount 30TS 60TS Service manual ADJUSTMENTS 53 6 1 4 SETTING THE POSITION OF THE CHAMBERS After setting the needle position according to chapter 5 2 2 and 5 3 1 the horizontal position of chamber bracket should be checked The needle must not go down exactly in the center of the chamber Chamber bracket can be moved left or right if necessary see picture FIGURE 52 Dual holez on chamber bracket fer setti the horizontal poston of chamber Human 2 FIGURE 53 FIGURE 54 6 2 HC30TS specific adjustments 6 2 1 SE
50. r 1 RBC Chamber MIX WBC Chamber only in HC60TS Puffer reservoir Lyse syrenge Dilutor 2 Valves 6 10 6 11 in HC60TS Human FIGURE 31 Construction side of HC30TS 1 MAIN board ES 2 Dimm PC FIGURE 32 Construction side of HC60TS 1 MAIN board 2 Dimm PC 2 SSS SSS SSS aa HumaCount 30TS 60TS Service manual OPERATION OF THE FLUIDIC SYSTEM 35 5 OPERATION OF THE FLUIDIC SYSTEM This section describes the main fluidic steps of HC30TS HC60 TS measurementcycle Theinstrument s FluidicSchematics areshowninSection10 4 of this manual The following figures show total measurement flow diagram and detailed descriptions of processes for understanding the fluidic system work The following steps are introduced in this section wr Flow diagram of measurement Initialization process Sampling process Needle washing process Diluting process Lysing process Counting process Chamber draining process Shutdown process In the detailed process description figures the active tube is filled with black color while an arrow shows the direction of the flow Moving mechanic parts have another arrow indicating direction of movement Only opened On valves are mentioned in this section while all the other valves are closed Off HC30TS HC60TS employs software counters to estimate waste and other re agent level Software integrates volume of the reagents used and gives
51. racter Start of Header lt SOH gt 1 0x01 The second character is a counter it will contain a single uppercase English letter in the range to Z incrementing with every record The first record will contain the second will contain etc If the instrument sends many records without being turned off the counter will overflow from Z to The third character is an identifier if the instrument is an ABJV5 it will be an up percase A and in case ofthe HC30 60TS it will be an uppercase N The fourth character is the control character Start of Text lt STX gt 2 0x02 The fifth and consecutive characters form the body of the transmission The body may con tain characters from the printable range 32 126 0x20 0xFF and the control characters Horizontal tab lt HT gt or TAB 9 0x09 Carriage return CR 13 OxOD and Line feed lt LF gt 10 Ox0A The body contains several lines separated by a two byte sequence lt CR gt lt LF gt See below for the detailed descrip tion of the contents The body of the transmission is closed by the control cha racter End of Text lt ETX gt 3 0x03 The footer consists of a two character checksum in a two digit hexadecimal form The checksum is calculated by summing up the values of all characters in the message header and body including the beginning SOT character and the last lt ETX gt character adding 255 h
52. ram b eog pue NAO pog NIVIN SOV 4215 951 7 m Jejuud HumaCount 3015 6075 Service manual FUNCTIONAL DESCRIPTION 3 1 1 COUNTING CHAMBER WITH ELECTRODES AND MEASURING APERTURE Impedance method is used for determination of volume and number of cells In this method a known volume of dilution is drawn through a small aperture Constant current is passed through the aperture from one side to the other When a cell passes through the aperture it causes a change in resistance which generates a voltage pulse The amplitude of the voltage pulse is proportional to the ratio of cell volume per aperture volume This is used to determine the volume of cells The number of cells can be obtained by counting the pulses In the HC30P there is one cell counter probe the aperture size is 70 um and has a reference electrode assembly and U shaped metal fixing as it is shown in the figure below The aperture is made of ruby and it is molded into the end of the measuring tube In the HC60P there are two separate chambers one for counting RBC with an aperture of 80 um and another for MIX WBC HGB with 100 um aperture FIGURE 3 Measuring chamber fF W N B Washing inlet Counting chamber Opening for measuring tube Chamber extender Platinum electrode
53. rvice manual SERVICE OPERATION measuring chamber mainly WBC WBC histogram peak or PLT becomes low soon Normally a good cleaner 15 required to dissolve lipid or protein build up Sometimes the cleaner is not strong enoughto keepthistube clean enough Periodic washing using 1 hand warm bleach solution helps 8 1 4 2 Bad insulation of electronic signal paths In these cases check for any capacitive coupling of electronic signals to the chamber Interference with HGB head high frequency signal is coupled to the cham ber HGB head metal parts must be grounded The ground comes externally it must bein place otherwise HGB head does not shield but couples in noise Interference with internal high voltage inverter high frequency signal is coupled tothe chamber Repair is required avoid near contact of HVB cable to chamber or shielded amplifier cable Interference with internal start button polling signal to start button may cause noise Guide start button wires as far from chamber as possible You may try mix them up on the start micro switch if applicable Interference with display cable high frequency LCD signal is coupled to the chamber by the ribbon cable Keep the ribbon cable far from the chamber Interference with CPU fan or other digital logic traces CPU fan or other digital signal radiates to chamber or to the shielded amplifier cable Try keeping the ribbon cables far from the chamber and shielded cable 8 1 4 3 Bad
54. sample are somewhat lyse resistive Probably large PLTs or clumped PLTs are present in the sample Usually caused by the nature of the sample cat and goat samples tend to clump Intensive but careful mixing of the sample e g Vortex can help remove the clumps If the rerun sample gives the same results consider that WBC and NEU values seem higher because of the clumps Lyse modification can t solve the problem 75 TABLE 3 Summary of warning flags related to WBC HGB Human N 16 Typically insufficiently lysed RBC s interfere with the start of the WBC histogram Repeating the measurement with an increased lyse volume should provide better separation If the repeated run reports very similar results then the MON and NEU results are VALID but the WBC and LYM results may be higher because of interfering RBCs Aperture clogging Perform cleaning and repeat the measurement If it 15 general problem please contact your Service Personnel Low temperature reagents can cause it as well mainly diluent in this case you will have to wait until they reach room temperature RBC WBC limit war ning WBC clogging Warning flags in lowercase refer to RBC or PLT problems Flag Meaning Recommended user action TABLE 4 linearity range The analyzer found that the cell count 15 exceeded PLT RBC higher than the linearity range of the analyzer stage Make a predilution and run the same sample in prediluted m
55. t Diagnostics gt Service The service menu is accessible for only SERVICE user To login as service user please see chapter 6 2 5 JCE Troubleshooting Needle positon check 61 Human 2 62 7 2 2 TROUBLESHOOTING With Troubleshooting options provide tools to test mechanical components Motors Optos Valves Amp Offset Home From the Motor Test submenu the service person could run each or all motor tests Optosensor s states can be checked in this screen rr nH HumaCount 30TS 60TS Service manual CHECKIG THE PROPER OPERATION 63 Pressing the O or 1 buttons the valves could be toggled 1 stands for electronically forced state Pressing the Pump 0 or 1 button the peristaltic pump could be switched on off The current vacuum in the puffer reservoir is displayed under the buttons JE Je ES You can check the offset on the amplifier board The current offset and the acceptance range are displayed 10 mw 10 ms 7 2 3 STRESS In Stress mode the instrument performs measuring cycles without sample blank measurements continuously This can be used for burn in tests to check pneumatic system after changing any main fluidic parts You can have information about stability cleanliness HGB operation and counting time stability Results of the PLT and HGB blank results are displayed in table format Human 2 64 You ca
56. t good enough ground terminal can be come a noise source as well i e external signals will be coupled into the system instead of protecting it If no earth ground is available you can use a screw atthe rear panel to connect a ground potential to the case so that noise immunity can be increased Measure voltage on ground terminal to make sure earth grounding is correct AC voltage lower than 1V is accepted in this case At some places as a bad practice electricians like to connect earth ground terminal to neutral wire Depending on the resistance of the neutral back wire where it is really earthed several volts can appear and this way any 67 Human 68 inductive noise will be coupled into the instrument It is better to create a real earth grounding and connect it to the rear screw 8 1 3 EXTERNAL ELECTRICAL NOISE If another instrument is near the analyzer can radiate electromagnetic signals in the 1 kHz 100 kHz frequency region it can be picked up by the system especially if they are very close to each other or the grounding is not quite per fect You can easily identify this noise source by relocating the instrument noise high PLT blank disappears In this case you have to identify the possible noise source switch mode power supplies computer monitors since they are not shielded centrifuges due to high switching noise of rotor contacts etc the power of the electromagnetic source because if high power
57. tes the beginning of the RBC histo gram rbcscale is maximum 3 digit number indicating the fl value of the last channel value is usually 200 rbcchannels is the number of channels columns in the histogram always 256 rm1 is the RBC discriminator channel PLT RBC chxx is the histogram height at a given channel range Points lt HT gt chO lt HT gt lt HT gt ch2550 255 there are always rbcchannels values here usually EOS graph Scale fl lt HT gt eosscale Channels lt HT gt eoschannels EMarker1 lt HT gt em1 256 always the same indicates the beginning of the EOS histo gram eosscale is maximum 3 digit number indicating the fl value of the last channel value is usually 400 eoschannels is the number of channels columns in the histogram always 256 em1 is the EOS discriminator channel WBC EOS chxx is the histogram height at a given channel range Points lt HT gt chO lt HT gt lt HT gt ch2550 255 there are always eoschannels values here usually PLT graph Scale fl HT pltscale Channels lt HT gt pltchannels PMarker1 HT pm1 PMarker2 HT pm2 256 always the same indicates the beginning of the PLT histo gram pltscale is maximum 3 digit number indicating the fl value of the last channel value is usually 50 pltchannels is the number of channels columns in the histogram always 256 pm1 is the first PLT discriminator channel PLT start pm2 is the second PLT discriminator c
58. unter Amplifier Board HC60TS MAIN CPU Board Dimm PC Module Opto sensors Valve boards TFT Display and START button Board 3 1 10 External Power Supply 4 MAIN MECHANIC AND FLUIDIC PARTS 4 1 SINGLE PARTS 4 1 1 4 1 2 4 1 3 4 1 4 4 1 5 4 1 6 4 1 7 4 1 8 4 1 9 Sample Horizontal and Vertical motors Sampling needle Needle washing head Puffer reservoir Dilutor block HC30TS Dilutor block HC60TS Measuring block HC30TS Measuring block HC60TS Pump Ui Ul 11 11 11 13 13 15 16 16 17 19 22 22 23 23 24 25 26 26 27 27 27 28 29 30 30 31 4 2 ASSEMBLED ANALYZER 4 2 1 Front Panel 4 2 2 Side Panel 4 2 3 Rear Panel HC30TS 4 2 4 Construction Front 4 2 5 Construction Side 5 OPERATION OF THE FLUIDIC SYSTEM 5 1 INITIALIZATION OF THE FLUIDIC SYSTEM 5 2 OPERATION OF THE FLUIDIC SYSTEM IN HUMACOUNT 30 TS 5 2 1 Flow diagram of measurement 5 2 2 Sampling process 5 2 3 Needle washing process 5 2 4 Diluting process 5 2 5 Lysing process 5 2 6 Counting process 5 2 7 Chamber draining process 5 2 8 Shutdown process 5 3 OPERATION OF THE FLUIDIC SYSTEM IN HC60TS 5 3 1 Sampling process 5 3 2 Diluting process 5 3 3 Lysing process 5 3 4 Counting process 5 3 5 Chamber draining process 5 3 6 Cleaning process 5 3 7 Shutdown process 6 ADJUSTMENTS 6 1 COMMON ADJUSTMENTS 6 1 1 Vertical movement setting timing belt tension 6 1 2 Vertical opto sensor and needle settings 6 1
59. wer of motors and valves Motor drivers 4 power drivers Horizontal Vertical Sample rotor motors and dilutor motors 2 in HC60TS have separated ribbon cable connections Valve driver consists two 8 bit powered output shift registers with built in protection diodes and there is one common ribbon cable connection for the valve boards The peristaltic pump has a separated power FET driver circuit for more reliable operation Measurement processing the A D conversion made by the micro controller itself but several preprocessing steps time limits noise handling pulse integration taken by the external analog circuitry Human N 20 FIGURE 9 Main board front view 1 Power Supply for internal printer 7 5 VDC 2 Opto detectors shift regi ster USB HUB DIMMPC RS232 USB Converter L LE F E Li Speaker FPGA Power Supply 12VDC 5VDC 3 3VDC 9 High Voltage Circuit 12VDC 12VDC 50VDC for OO A W measurement 150VDC for cleaning 10 Microcontroller 11 TFT connection 12 TFT backlight driver 13 Motor drivers 14 Valve drivers 15 Pump drivers A HumaCount 30TS 60TS Service manual FUNCTIONAL DESCRIPTION B N on U 10 11 12 13 14 21 FIGURE 10 Main board rear view Pressure Sensor Motor Connectors Front Panel USB Connector Connector to TFT Backlight a
60. ystem consists of the remaining fluidic components Thanks to this two parallel subsystems the measuring is could be started during the chamber washing processes The separate RBC and MIX WBC chambers make two different diluents mixes possible simultaneously FIGURE 41 RBC chamber Both chambers Chamber subsystem F OW d ia g ram of Cleaning Sampling process chambers measurement HGB Blank measurement Chamber draining Needle washing __ __ e Diluting process 1 160 Diluting process 1 160 Sampling process from primary dilution Needle washing Dilution process Dilution process 1 23000 1 23000 e Li e Y Generating measuring vacuum Oeo WBC counting process HGB measurement RBC counting process Draining Cleaning FastBlank measurement C END J JP uer HumaCount 30TS 60TS Service manual OPERATION OF THE FLUIDIC SYSTEM 45 5 3 1 SAMPLING PROCESS The aspirating needle aspirates 25 uL 50 uL in prediluted mode

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