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Servicemanual

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Hemolyzer 5 This service manual is intended to give detailed information for service engineers of Analyticon Biotechnologies AG Hemolyzer 5 optical hematology analyzer. All information contained herein is the intellectual property of Analyticon Biotechnologies AG and should not be used or reproduced without prior agreement of Analyticon Biotechnologies AG, the manufacturer. This manual was written with the intention to give the most precise and up-to-date, detailed description of operation and use of the analyzer for laboratory purposes. Despite careful revision and multiple grammar and content control, mistakes can still be present in this manual. Analyticon may from time to time issue errata, or a new revision of the manual. Would you find things unclear, please contact [email protected] for assistance. User’s manual contains important information about the operation and measurement principles of Hemolyzer 5. Specifications, definition of parameters and user interface are also described therein, consequently Service manual does not contain these data. Use of the Service manual assumes knowledge of the information contained in the User’s manual.

Analyticon Biotechnologies AG Technical Support Team

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Servicemanual

Table of Contents TABLE OF CONTENTS .......................................................................................................................... 3 1

INTRODUCTION ............................................................................................................................. 8 1.1

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FOR YOUR SAFETY ...................................................................................................................... 9 2.1 2.2 2.3 2.4 2.5 2.6 2.7 2.8 2.9

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W HO SHOULD READ THIS MANUAL ............................................................................................... 8

SPECIAL SYMBOLS USED IN THIS MANUAL .................................................................................. 9 GENERAL PRECAUTIONS ............................................................................................................ 9 ENVIRONMENTAL FACTORS ...................................................................................................... 10 ELECTRICAL REQUIREMENTS .................................................................................................... 11 SUGGESTED ON-LINE UPS ....................................................................................................... 11 PROPER PLACEMENT OF HEMOLYZER 5 .................................................................................... 12 W EIGHT REQUIREMENTS .......................................................................................................... 12 W ASTE DISPOSAL .................................................................................................................... 13 EMERGENCY SITUATIONS ......................................................................................................... 13

STRUCTURE OF THE ANALYZER.............................................................................................. 14 3.1 COMPONENTS LOCATED ON THE FRONT PANEL .......................................................................... 14 3.1.1 Display screen and the touch sensitive surface ................................................................ 14 3.1.2 Start Button and LEDs ....................................................................................................... 15 3.2 COMPONENTS ACCESSIBLE AFTER OPENING THE FRONT PANEL .................................................. 15 3.2.1 Shear Valve Assembly ...................................................................................................... 15 3.2.2 Sample rotor ...................................................................................................................... 15 3.2.3 Main Dilutors ...................................................................................................................... 16 3.2.4 Dilutor opto sensor boards ................................................................................................ 17 3.2.5 Tube organizer................................................................................................................... 17 3.2.6 Temperature Control Unit .................................................................................................. 17 3.2.7 Laser head ......................................................................................................................... 18 3.2.8 Laser Head Assembly + Sample Injector .......................................................................... 19 3.2.9 Laserdiode Driver Board .................................................................................................... 20 3.2.10 Pin Photodiode and Amplifier (OPTSENSOR_2v1) ...................................................... 20 3.3 LEFT SIDE ................................................................................................................................ 21 3.3.1 Valve boards ...................................................................................................................... 21 3.3.2 WBC/BASO Preheater Assembly ...................................................................................... 22 3.3.3 Counting chamber with electrodes and measuring aperture ............................................. 22 3.3.4 HGB Measuring Head ....................................................................................................... 23 3.3.5 Cell counter Amplifier Board .............................................................................................. 24 3.3.6 Pressure sensor board ...................................................................................................... 25 3.3.7 Reagent and Vacuum buffers ............................................................................................ 26 3.3.8 Reagent Sensor Board ...................................................................................................... 27 3.3.9 Opening the valve assembly plate..................................................................................... 27 3.3.10 Vacuum buffer ............................................................................................................... 27 3.3.11 Pneumatic and Power Boards (PPB1 and PPB2) ......................................................... 28 3.3.12 Pump assembly ............................................................................................................. 29 3.4 RIGHT SIDE .............................................................................................................................. 30 3.4.1 XY unit ............................................................................................................................... 30 3.4.2 XYROpto Board ................................................................................................................. 31 3.4.3 Sampling needle ................................................................................................................ 31 3.4.4 Blood sensor ...................................................................................................................... 31 3.4.5 Wash head......................................................................................................................... 32 3.4.6 Processor unit (LS-DACQ board with DimmBoard) .......................................................... 32 3.4.7 Mini-ITX PC mother board (In Hardware block) ................................................................ 37

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ELECTRONIC BLOCK DIAGRAM ............................................................................................... 38 4.1 4.2 4.3

HARDWARE BLOCK .................................................................................................................. 38 DATA ACQUISITION UNIT .......................................................................................................... 40 AMPLIFIER BOARD .................................................................................................................... 42

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Hemolyzer 5 4.4 5

OPERATION OF THE FLUIDIC SYSTEM .................................................................................... 44 5.1 5.2 5.3 5.4 5.5 5.6 5.7 5.8 5.9 5.10 5.11 5.12 5.13 5.14 5.15 5.16 5.17

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OPTICAL HEAD......................................................................................................................... 43

THE REAGENT SYSTEM............................................................................................................. 44 FLOW DIAGRAM OF MEASUREMENT............................................................................................ 45 INITIALIZATION OF THE FLUIDIC SYSTEM .................................................................................... 47 REAGENTS PRIMING ................................................................................................................. 47 PIERCING PROCESS ................................................................................................................. 47 SAMPLING PROCESS ................................................................................................................ 47 NEEDLE WASHING PROCESSES ................................................................................................. 48 DILUTING PROCESSES .............................................................................................................. 48 LYSING PROCESS ..................................................................................................................... 48 RBC COUNTING PROCESS ........................................................................................................ 49 WBC/BASO COUNTING ........................................................................................................... 49 WBC 4DIFF COUNTING ............................................................................................................ 49 CHAMBER DRAINING PROCESSES .............................................................................................. 50 CLEANING (RINSING) PROCESSES ............................................................................................. 50 STANDBY PROCESS .................................................................................................................. 50 W AKE UP PROCESS .................................................................................................................. 51 SHUTDOWN PROCESS .............................................................................................................. 51

ADJUSTMENTS ............................................................................................................................ 52 6.1 XY UNIT MECHANICAL ADJUSTMENTS ........................................................................................ 52 6.1.1 XY horizontal movement ................................................................................................... 52 6.1.1.1 6.1.1.2

6.1.2

XY vertical adjustment ....................................................................................................... 55

6.1.2.1 6.1.2.2

6.1.3 6.1.4

Greasing the horizontal rods ................................................................................................... 52 Set opto flags for horizontal movement................................................................................... 53 Basic operation ....................................................................................................................... 55 Adjusting the needle’s vertical position ................................................................................... 56

Washing head settings ...................................................................................................... 56 Needle setting .................................................................................................................... 57

6.1.4.1 6.1.4.2

Handmade setting ................................................................................................................... 57 Software made setting ............................................................................................................ 58

6.2 SHEAR VALVE MECHANICAL SETTING ......................................................................................... 58 6.2.1 Shear valve lower disc position setting ............................................................................. 59 6.2.2 Shear valve upper disc setting .......................................................................................... 59 6.2.3 Setting the opto sensors of the shear valve. ..................................................................... 61 6.3 AMPLIFIER OFFSET SETTING ..................................................................................................... 62 6.4 BLOOD SENSOR CALIBRATION ................................................................................................... 63 6.5 SAMPLE POSITION SETTING....................................................................................................... 65 6.6 PRESSURE SENSOR ADJUSTMENT ............................................................................................. 66 6.7 SET SERIAL NUMBER ................................................................................................................ 67 6.8 WBC PREHEATER .................................................................................................................... 67 6.9 SETTING LASER VALUES ........................................................................................................... 67 6.9.1 Calibration procedure of optical heads .............................................................................. 67 6.9.2 Short guide for laser values ............................................................................................... 71 7

VERIFICATION PROCEDURES ................................................................................................... 74 7.1 SELF-TEST............................................................................................................................... 74 7.1.1 Hemolyzer 5 Self-Test Guide ............................................................................................ 75 7.1.1.1 7.1.1.2 7.1.1.3

General information ................................................................................................................ 75 Electronic Self-Test parameters .............................................................................................. 75 Pneumatic Self-Test parameters............................................................................................. 77

7.2 ERROR MESSAGES .................................................................................................................. 79 7.3 SERVICE MENU ........................................................................................................................ 84 7.3.1 Service functions ............................................................................................................... 86 7.3.1.1 7.3.1.2 7.3.1.3 7.3.1.4 7.3.1.5 7.3.1.6

Test functions.......................................................................................................................... 87 Low level file management...................................................................................................... 87 Low level reboot (DimmBoard)................................................................................................ 87 Pneumatical System – Initialize .............................................................................................. 87 Network management ............................................................................................................. 88 RAW data saving mode .......................................................................................................... 88

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Servicemanual 7.3.1.7 7.3.1.8 7.3.1.9 7.3.1.10 7.3.1.11 7.3.1.12 7.3.1.13 7.3.1.14 7.3.1.15 7.3.1.16 7.3.1.17

7.3.2 7.3.3

Service testing ................................................................................................................... 89 Service calibration ............................................................................................................. 90

7.3.3.1 7.3.3.2 7.3.3.3 7.3.3.4 7.3.3.5 7.3.3.6 7.3.3.7

7.3.4 7.3.5 7.3.6

Export RAW files ..................................................................................................................... 88 Windows Control Status .......................................................................................................... 88 TCU fill/drain ........................................................................................................................... 88 Flow cell fill/drain..................................................................................................................... 88 Blood sensor status ................................................................................................................ 88 Reset statistics ........................................................................................................................ 88 Hard drive maintenance .......................................................................................................... 88 Show advanced DB view ........................................................................................................ 88 Small sample mode ................................................................................................................ 89 Pre-diluted mode..................................................................................................................... 89 Monitoring ............................................................................................................................... 89

Enable scatter calibration ........................................................................................................ 90 Backup Calibration .................................................................................................................. 90 Restore Calibration ................................................................................................................. 90 Load Calibration ...................................................................................................................... 90 Accept User factors ................................................................................................................. 91 Back ........................................................................................................................................ 91 Accept ..................................................................................................................................... 91

Stress measure.................................................................................................................. 91 Auto alignment ................................................................................................................... 92 AS (Auto-sampler) ............................................................................................................. 92

7.3.6.1 7.3.6.2 7.3.6.3 7.3.6.4 7.3.6.5 7.3.6.6

Go to Pos ................................................................................................................................ 92 Reset ...................................................................................................................................... 92 Repeat last command ............................................................................................................. 92 Go To Mixer ............................................................................................................................ 92 Load to sampling position ....................................................................................................... 92 Set up Barcode Reader .......................................................................................................... 93

7.3.7 Adjustments ....................................................................................................................... 93 7.3.8 Multiuser Settings .............................................................................................................. 94 7.3.9 MDA view ........................................................................................................................... 94 7.3.10 Software upgrade .......................................................................................................... 95 7.3.10.1 7.3.10.2 7.3.10.3 7.3.10.4 7.3.10.5 7.3.10.6 7.3.10.7 7.3.10.8

Refresh data ........................................................................................................................... 95 Change High Level software ................................................................................................... 95 Change Low level software ..................................................................................................... 95 Change Low level boot ........................................................................................................... 95 Change LSDACQ firmware ..................................................................................................... 95 Change Optical Head Firmware .............................................................................................. 95 Change TCU software ............................................................................................................ 95 Change AutoSampler software ............................................................................................... 95

7.3.11 Reagent Lock................................................................................................................. 96 7.3.12 QC Wizard ..................................................................................................................... 97 7.3.13 Printer installation .......................................................................................................... 97 7.3.14 Factory Settings ............................................................................................................. 97 7.3.15 Service mode OFF......................................................................................................... 97 7.4 SOFTWARE SYSTEMS ............................................................................................................... 98 7.5 GENERAL SW INSTALLATION GUIDE .......................................................................................... 98 7.5.1 Install operating system Windows 2.0 install using pendrive .......................................... 100 7.5.2 Installing a Printer ............................................................................................................ 104 8

INSTALLATION .......................................................................................................................... 105 8.1 CHECK THE DELIVERY ............................................................................................................ 105 8.2 PREPARE FOR INITIAL INSTALLATION ....................................................................................... 105 8.2.1 Select a Suitable Location ............................................................................................... 105 8.2.2 Make Any Special Arrangements .................................................................................... 105 8.2.3 Gather Your Peripherals Devices .................................................................................... 106 8.3 PERFORMING THE INSTALLATION............................................................................................. 106 8.3.1 Move the ‘Hemolyzer 5’ to the Selected Location ........................................................... 106 8.3.2 Visual Inspection.............................................................................................................. 106 8.3.3 Remove the Protective Card from the Shear Valve ........................................................ 106 8.3.4 Connect the Optional Auto-Sampler ................................................................................ 107 8.3.5 Connect the Reagents ..................................................................................................... 107 8.3.6 Connect the Power Cord ................................................................................................. 108

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Hemolyzer 5 8.3.7 Verify the ‘Hemolyzer 5’ Computer Operation ................................................................. 109 8.3.8 Connect Peripherals ........................................................................................................ 109 8.3.9 How to install a printer ..................................................................................................... 110 8.3.10 Initializing the Optional Autosampler ........................................................................... 110 8.3.11 Using the Settings Menu ............................................................................................. 112 8.3.12 Set Up a Laboratory Information System (LIS) ........................................................... 112 8.3.13 Set Up a Serial LIS Connection ................................................................................... 113 8.3.14 Set Up an Ethernet LIS Connection ............................................................................ 114 8.3.15 Running Blank Samples and Blood Samples for the First Time ................................. 114 8.4 CHECKLIST FOR INSTALLING HEMOLYZER 5 HEMATOLOGY ANALYZER ........................................ 115 9

TROUBLESHOOTING ................................................................................................................ 117 9.1 TROUBLESHOOTING CHECKLIST FOR HEMOLYZER 5 HEMATOLOGY ANALYZER .................................. 117 9.1.1 Visual inspection .............................................................................................................. 117 9.1.2 Powering up the system .................................................................................................. 118 9.1.3 Checking the software adjustments................................................................................. 118 9.1.4 Checking the Hardware adjustments............................................................................... 119 9.1.5 Run a Self-test ................................................................................................................. 120 9.1.6 Run Blank measurements ............................................................................................... 120 9.1.7 Run Control measurements ............................................................................................. 121 9.2 MECHANICAL PROBLEMS ........................................................................................................ 122 9.2.1 General guidelines to overcome motor or moving part related problems ....................... 122 9.2.2 Sample Rotor (SR or BOB) failures ................................................................................. 123 9.2.2.1 9.2.2.2 9.2.2.3

9.2.3

Needle mechanics, Vertical motor (MVert) problems ...................................................... 123

9.2.3.1 9.2.3.2

9.2.4

SV error at the first startup .................................................................................................... 124 Grinding noise after SV cleaning, (after SV reinstallation) .................................................... 124 SV leakage............................................................................................................................ 124

Dilutor errors .................................................................................................................... 125

9.2.5.1 9.2.5.2

9.2.6 9.2.7

The needle carriage keeps dropping back (down) at initialization ......................................... 123 MVert cannot reach the optosensor (Up or Down) ................................................................ 123

Shear Valve (SV) related errors ...................................................................................... 124

9.2.4.1 9.2.4.2 9.2.4.3

9.2.5

SR gives grinding noise and / or SW displays SR error messages ....................................... 123 SR error appears during initialization process:...................................................................... 123 The SR does not turn into the analyzer even with open front panel ...................................... 123

Dilutor is making noise .......................................................................................................... 125 Dilutor is leaking.................................................................................................................... 125

A tube comes off of a valve ............................................................................................. 125 Priming problems ............................................................................................................. 125

9.2.7.1

The analyzer would not prime liquids .................................................................................... 125

9.3 ELECTRONICS RELATED PROBLEMS ......................................................................................... 126 9.3.1 Touch screen / display errors .......................................................................................... 126 9.3.1.1 9.3.1.2 9.3.1.3 9.3.1.4

No image on display ............................................................................................................. 126 Touch sensitive surface not working ..................................................................................... 126 Touch (click) is inaccurate..................................................................................................... 126 Screen image is not normal, some parts of the software screen is not visible ...................... 126

9.3.2 Communication errors ..................................................................................................... 127 9.3.3 The analyzer does not power on ..................................................................................... 127 2 9.3.4 I C errors displayed at startup ......................................................................................... 128 9.4 USEFUL INFORMATION AND TIPS.............................................................................................. 128 9.4.1 High PLT background ...................................................................................................... 128 9.4.2 Fast Starting up and Shutting down ................................................................................ 128 9.4.3 Removing bubbles from the Flow cell.............................................................................. 128 9.4.4 Removing the DimmBoard .............................................................................................. 129 9.4.5 Listen the sounds of the instrument ................................................................................ 129 9.4.6 Replacing small diameter tubes ...................................................................................... 129 9.4.7 Swapping the pumps ....................................................................................................... 129 9.4.8 Draining the reservoirs .................................................................................................... 129 10

MAINTENANCE .......................................................................................................................... 130

10.1 USER MAINTENANCE .............................................................................................................. 130 10.1.1 Daily maintenance ....................................................................................................... 130 10.1.2 Weekly maintenance ................................................................................................... 130

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Servicemanual 10.1.2.1 10.1.2.2

10.2 10.3 11

Shear Valve cleaning ............................................................................................................ 130 Cleaning the wash head ....................................................................................................... 130

PREVENTIVE MAINTENANCE.................................................................................................... 130 FLOW CELL CLEANING ............................................................................................................ 136

REMOVAL AND REPLACEMENT PROCEDURES ................................................................... 139

11.1 OPENING THE INSTRUMENT..................................................................................................... 139 11.2 SHEAR VALVE ASSEMBLY ....................................................................................................... 140 11.3 XY UNIT ................................................................................................................................ 141 11.4 SAMPLE ROTOR ..................................................................................................................... 144 11.5 DILUTORS .............................................................................................................................. 145 11.5.1 Syringe replacement .................................................................................................... 145 11.6 TCU MODULE........................................................................................................................ 146 11.7 VALVE BLOCK ........................................................................................................................ 147 11.8 PRE-AMPLIFIER BOARD .......................................................................................................... 148 11.9 PUMP ASSEMBLY ................................................................................................................... 148 11.10 HARDWARE MODULE .......................................................................................................... 150 11.11 LASER HEAD ASSEMBLY ..................................................................................................... 151 11.11.1 Reinstalling the Laser Head: ....................................................................................... 154 11.12 MEASURING BLOCK............................................................................................................ 154 11.12.1 Aperture removal: ........................................................................................................ 154 11.12.2 WBC aperture removal: ............................................................................................... 155 11.12.3 Measuring Chamber removal: ..................................................................................... 155 11.12.4 HGB head removal ...................................................................................................... 156 11.13 DISPLAY UNIT..................................................................................................................... 156 11.14 HEMOLYZER 5 FLUIDICS V2.1 - SV IN CHAMBER POSITION ................................................... 158 11.15 HEMOLYZER 5 FLUIDICS V2.1 - SV IN NEEDLE POSITION ...................................................... 159 11.16 TUBINGS............................................................................................................................ 160 12

APPENDIX .................................................................................................................................. 171

12.1 12.2 12.3

RECOMMENDED KIT OF TOOLS ................................................................................................ 171 HOW TO SEND .RP FILES TO ASSESSMENT OF ANALYZER PERFORMANCE ................................... 171 HOW TO USE THE „COLLECT” FUNCTION OF THE HEMOLYZER 5 HEMATOLOGY ANALYZER ........... 172

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Hemolyzer 5

1 INTRODUCTION 1.1 Who should read this manual This Service manual is intended for trained technicians or service engineers to be able to maintain and repair Hemolyzer 5 automated hematology analyzer. It contains the functional descriptions of the analyzer, operation of the fluidic system, adjustments and settings, and very important information for the Service Personnel about the service operations and possible problems. If equipment operation is different from the manufacturer’s specifications and intended use, the protection provided by the equipment may be impaired. Misuse of equipment or use other than its intended purpose will invalidate conditions of warranty. Accuracy and precision may also be impaired. Follow the service procedures described herein to guarantee functional operation after repairs and maintenance.

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Servicemanual

2 For Your Safety 2.1 Special Symbols Used In This Manual Label

Meaning

Explanation

Biohazard

Blood samples and analyzer waste are potentially infectious materials.

Corrosive

Reagents may cause corrosion or skin irritation.

Warning

General warning of possible hazard conditions.

Sharp needle warning

The sampling needle may be a hazard to the operator.

2.2 General Precautions The sampling needle and other components inside the analyzer may cause injury, or can get damaged if handled incorrectly. Only certified personnel should open the covers. Running measurements with opened cover is not recommended due to the risk of possible injury. Always wear safety gloves while performing maintenance actions. The analyzer weighs 35kg (~77lbs). Please do not attempt to move it alone. The analyzer should always be moved by two persons holding the analyzer by its sides in an upright position. Always use safe lifting procedures when lifting the analyzer. Make sure to retain the original packaging material for safe transportation and storage in the future. To prepare the analyzer for shipping, storage or extended periods of inactivity, please drain the reagents and repackage the Hemolyzer 5 in its original packaging. Do not expose the Hemolyzer 5 to direct sunlight, extreme temperature or humidity (>80%). The analyzer operates with chemically and biologically active reagents. Physical contact with these reagents should be avoided. Please read reagent descriptions carefully for possible emergency actions.

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Hemolyzer 5 To ensure reliable operation and reliable results: • • •

Only genuine Analyticon reagents should be used Required service maintenance should be performed as recommended in this manual Only genuine Analyticon service materials and spare parts should be used for repairs

Genuine reagents and service materials and spare parts are available from Analyticon. Only Analyticon certified service personnel that have successfully completed the ‘Hemolyzer 5 Service Training’ program are qualified to service the Hemolyzer 5 analyzer. Before operating Hemolyzer 5 analyzer, all operators should complete an ‘Hemolyzer 5 Operator Training’ program. This program is offered by Analyticon or by Analyticon certified service personnel. Replacement materials or spare parts (tubes, valves, etc.) which might have been in contact with human blood or reagents should be handled as a potentially biologically hazardous and chemically dangerous material. All applicable laws and regulations must be observed in the handling and disposal of these materials. Hemolyzer 5 is designed for laboratory operation. Mobile operation is not supported. Operate Hemolyzer 5 within the ambient temperature range described in User Manual section 2.4. The IVD equipment complies with the emission and immunity requirements described in relevant part of the IEC 61326 series. This equipment has been designed and tested to CISPR 11 Class A. In a domestic environment it may cause radio interference, in which case, you may need to take measures to mitigate the interference. Electromagnetic environment should be evaluated prior to operation of the device. This analyzer contains electronic components. Please handle electronic waste adhering to local or federal regulations. CAUTION – Use of controls or adjustments or perfomance of procedures other than those specified herein may result hazardous radiation exposure.

2.3 Environmental Factors Operate Hemolyzer 5 within the ambient temperature range of 15-30°C (59-86°F) and a relative humidity range of 10% - 80%. Optimum operating temperature is 25°C (77°F). Hemolyzer 5 should be stored within the temperature range of 5-35°C (41-95°F). Avoid exposing the analyzer to direct sunlight or to extreme high or low temperatures. If the analyzer was subjected to extreme temperatures during shipment or storage, it must be

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Servicemanual placed for at least two hours in a room whose temperature is within the operational range before installation or use. Reagents should be stored at a temperature range of 15-30°C (59-86°F). Reagents may experience a temperature range of at most 5-35°C (41-95 °F) for a maximum of 3 days. The analyzer should be placed in a well-ventilated location. Operation at an altitude above 2000 meters (6560 ft) is not guaranteed.

2.4 Electrical Requirements The analyzer should only be operated from a wall outlet meeting these power input requirements: • •

100-127VAC or 200-240VAC; 47Hz to 63Hz Power Consumption: maximum 400 VA (including power of the auto-sampler)

Please ensure that the wall outlet is also capable of supplying the power consumption of any additional devices (such as a printer). Use only the power cord supplied with the instrument. Avoid using extension cords. Hemolyzer 5 comes with a power cord appropriate for your power system. Proper use of the appropriate power cord assures adequate grounding of the system. If the power is not reliable, contact your representative for options such as the installation of an external UPS module. Failure to properly ground the Hemolyzer 5 bypasses important safety features and may result in electrical hazard. The instrument should not be placed near potentially interfering devices capable of emitting radio frequencies (e.g. radio or television transmitters/receivers, radars, centrifuges, X-ray devices, fans, etc.). This analyzer is designed to be safe for transient voltages to INSTALLATION CATEGORY II and POLLUTION DEGREE 2.

2.5 Suggested on-line UPS It is recommended to use a UPS (uninterruptible power supply) in line with the power input in the following circumstances: • •

if the main power is fluctuating in case of power black out happens frequently

Power consumption of the analyzer and optional Auto-sampler is 400VA max. If there is a power failure, the analyzer should be able to complete the function in progress and perform a Windows shut-down to secure data. In order to provide the necessary power, it is recommended to use a UPS with the following minimum specifications: 600 VA provides uninterrupted power for 10-15 minutes.

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Hemolyzer 5 Analyticon does not supply UPS for Hemolyzer 5. Therefore, Analyticon is not taking responsibility or liability for the operation of Hemolyzer 5 running on UPS. If you need further information, please, contact technical support of the UPS vendor.

2.6 Proper Placement of Hemolyzer 5 It is important to install the instrument in a suitable location, a poor location can adversely affect its performance: • Select a well-ventilated location near a power source and close to a suitable drain. • Place the unit on a clean, level surface. Leave at least 0.5 m (18 inches) space on both sides and above the instrument to access pneumatics. • A minimum of 0.2 m (8 inches) must be maintained between the rear panel and the wall to allow for heat dissipation and tubing clearance. • Ensure there is enough clearance in front of the analyzer to open front panel. Allow enough space if you want to use optional external keyboard, mouse or bar code reader. • Your selected location should allow placement of the reagents in an unobtrusive location below the laboratory bench that the instrument is placed on. Placement below the laboratory bench also allows for storage of a spare set of reagents. Never place the reagents above the Hemolyzer 5 analyzer. Placing reagents above the Hemolyzer 5 analyzer could result in reagent overflow and spilling. Always put the diluent tank on the floor, never to the same level where the analyzer is.

1. Figure: Spacing of Hemolyzer 5 with Auto-Sampler and reagents

2.7 Weight Requirements Hemolyzer 5 weighs 35 Kg (77 lb) without the Auto-sampler.

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Servicemanual Hemolyzer 5 with optional Auto-sampler weighs 47Kg (104 lb). Adding an external keyboard, printer, documents, etc. can bring the total weight up to 60 Kg (132 lb). Please select a table, laboratory shelf, or other location which can support the weight of the Hemolyzer 5 with all accessories and it is free from vibration. To allow reliable operation and to provide a safe working environment, make sure that the table supporting the unit is stable enough to carry the weight of the instrument and accessories.

2.8 Waste Disposal Waste of Hemolyzer 5 analyzer contains human blood and reagents that are chemically and biologically active, and should be considered to be a potential infection and biohazard threat. Safe laboratory practices must be followed including the use of personal protective when operating Hemolyzer 5 and handling blood, reagents, and waste. System waste should be handled as a potentially bio hazardous material. All applicable laws, regulations, and laboratory practices should be followed in the handling and disposal of waste.

2.9 Emergency Situations Always follow all applicable laws and regulations with regards to emergency situations. If Hemolyzer 5 needs to be powered off due to an emergency situation (like fire, thunderstorm, etc.), follow the procedures in User Manual section 7.3.4. In case of fire, do not use water to extinguish the fire unless Hemolyzer 5 is disconnected from the electrical network!

13

Hemolyzer 5

3 Structure of the analyzer Please, refer to the User’s manual for details on opening the front and side covers, and parts contained there.

3.1 Components located on the front panel The display panel and related components are covered with a metal plate, to avoid electronic interference causing problems, and to protect sensitive electronics.

3.1.1

Display screen and the touch sensitive surface

Hemolyzer 5 uses a color LCD with LED backlight touchscreen as main user interface.

The built-in touchscreen is a 4 wire resistive type. It is interfaced to the mainboard by a USB controller.

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Servicemanual 3.1.2

Start Button and LEDs

START Button board is mounted on the front panel. It contains a start button and two LEDs to illuminate the START button. The LEDs are bicolor: red and green LEDs. When both red and green are switched on, the resultant color is yellow.

3.2 Components accessible after opening the front panel 3.2.1

Shear Valve Assembly

Shear Valve assembly consists of the following • • • • •

3.2.2

parts:

Shear Valve holding plate, Moving mechanism, Stepper motor, Ceramic Shear Valve, Shear Valve optoboard.

Sample rotor

Hemolyzer 5 hematology analyzer has a sample rotor for safety and more precise sample handling.

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Hemolyzer 5 Sample rotor unit uses a stepper motor, connected to the PPB through the XY opto board. The rotor has micro switches for positioning. The unit blocks itself in the home and end position with mechanical parts and has a special cap that prevents the damage of the electronic and mechanic parts caused by any fluid.

Micro switches for positioning

Tube adapter

3.2.3

Main Dilutors

Hemolyzer 5 has two separate main dilutor modules. There are two stepper motors, a common motor opto board, four syringes and piston rods with gear transmission in each module. The software identifies and moves four dilutors (Dil1, Dil2, Dil3, Dil4), each dilutor consists of two syringes. Dilutor 1 and 2 is in Dilutor module 1, dilutor 3 and 4 is in Dilutor module 2, as represented in the picture below. Main Dilutor Module

Main Dilutor Module

Dil 1

Dil 2

Dil

16

Dil

Servicemanual 3.2.4

Dilutor opto sensor boards

Dilutors have their own separated opto-boards, located directly in the units. On the front side of the optoboards there are 4 optosensors and 4 control LED-s, on the back side are mounted the motor connectors and the flat cable connector.

3.2.5

Tube organizer

This is the component that provides arrangement for the tubes going from the valves to the dilutor, shear valve, optical head and Temperature Control Unit. It is intended to allow easy identification and access to tubes for service related cleaning procedures. Four tubes have metal through tubes to allow easier removal and replacement when necessary in case the TCU needs to be cleaned and rinsed.

3.2.6

Temperature Control Unit

Temperature Control Unit provides the necessary temperature for reagents used to create 4DIFF sample. It is able to heat or cool the sample and reagents, depending on the ambient

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Hemolyzer 5 temperature. It contains a massive, molded aluminum block. There are multiple, curved and interconnected stainless steel tubes (fluid paths) inside the TCU to ensure proper capacity. Parts of TCU: • • •

3.2.7

in-line mixer, for mixing and homogenizing sample and specific reagents. Temperature Controller Board, to monitor the temperature of the aluminum block by power transistors (heating elements) or Peltier cooling circuitry thermal insulation for temperature stability.

Laser head

Laser head is used for optical measurements of 4-DIFF and BASO parameters. 3 1. LASERDRV BOARD 2. LENS ASSEMBLY 3. OPTSENSE BOARD 4. SAFETY SWITCHES

1

5. SAMPLE INJECTOR 6. OPTICAL FLOW CELL 7. OPTICAL CABLE

2

4 6

5

7

Black anodized aluminum box works as safety cover. Two different micro-switches protect the technician against direct exposure to beam: •

When cover holder screws are removed laser activity will be switched off by laser driver board. • To turn on laser again, put the cover back, and fasten the screws so that both switches are closed and the low-level SW should be restarted. Optical measurement unit has a sheath and sample inlet, and a waste outlet from fluidic side, laser driver cable, analogue output cable and auto-alignment cable from the electronics.

18

Servicemanual 3.2.8

Laser Head Assembly + Sample Injector

Laser Head Assembly is responsible for detecting the 4diff and BASO cells from the prepared blood sample. The laser head is responsible for the precise illumination of the sample. The temperature controlled laser diode source is mounted on a huge brass basis which holds it tight and also responsible for the cooling. Just beside the laser diode aspheric and achromatic lenses performs the focusing of the laser beam. For accurate and stable adjustment, this optical unit is mounted on an aluminum block with a sphere-to-cone contact. Powerful springs hold the unit in place. Using stainless steel levers, the direction of the laser can be rotated around two axes. This means, the laser spot on the flow-cell can be tilted in horizontal and vertical directions. Precise linear motion stepper motors perform the accurate setting of the laser.

Coarse adjustment of the laser can be made by setting the rough adjustment screws. The flow-cell unit is responsible for the precise flow control and the pre-detection of the pulses. An optically clear flow-cell (cross section for flow is 0.25x0.25mm) is mounted with 2 side cone-to-cone connection into its holder. Below the flowcell an injector helps to insert the sample in the middle of the main sheath streamline. The sheath puffer opened to free air supplies the sheath and the sample flow. Cross section of the flow cell – sample injector assembly The size and position of the sampler needle, the different tube resistance of the sheath and sampler lines and the applied vacuum result an about 40nm wide sample stream in the middle of the flow-cell. Concentric ring shaped optical cable is also mounted to the flow-cell unit. This collects the scattered light from the cells, and transfers it to the detection unit. Just before the insertion zone of the optical cable, there is a laser dump for filtering direct laser beam.

19

Hemolyzer 5 3.2.9

Laserdiode Driver Board

The LASERDRV board is based on a PIC 24FJ64GA004 (Microchip) microcontroller that performs all the control functions of the laser diode and the communication with the LS-DACQ (DimmBoard). The LASERDVR board incorporates a laser diode with built-in APC (automatic power control). The laser power can be set by a programmable digital potentiometer in the 1.8 – 5.5 mW range. The laser can be switched on and off from program. The laser diode temperature can be set, and then the microcontroller will keep the diode temperature at the preset value. As the temperature control uses only heating (2 transistors), stable diode temperature can be maintained only above room temperature. The LASERDRV board provides laser safety functions too. When removing the laser cover, the safety switches cut off laser power immediately. In order to turn the laser on the cover must be in replaced and the instrument must be turned off and back on. The controlling interface between the LS-DACQ and the LASERDRV is I2C.

3.2.10 Pin Photodiode and Amplifier (OPTSENSOR_2v1) When a blood cell in the diluted and lysed blood stream crosses the focused laser light, the light scatters and two pin photodiodes sense the scattered light. The current, generated by the two photodiodes has to be handled separately, so two independent analog channels are used on the OPTSENSOR board. The photodiode’s current is amplified by one transimpedance amplifier per channel.

Then the DC level is removed, and more amplification is applied. The DC level of output 0 and 1 (AOUT0, AOUT1) are clamped to +1V. The output span is 2V, so the output range is +1V..+3V. This is appropriate for the A/D converter on the LS-DACQ, that has a 2V input voltage span, only the offset has to be set according to the A/D’s requirement (+1.5V..+3.5V). The 3rd analog channel (AOUT2) outputs the DC level of channel 0, amplified by 2. It can be used for the auto alignment of the laser. The OPTSENSOR card contains the connectors and LEDs for AutoAlignment motors, as well as position sensing.

20

Servicemanual

3.3 Left side 3.3.1

Valve boards

The Hemolyzer 5 system incorporates 44 valves. The valve boards are controlled by two Pneumatic and Power Board (PPB) boards. The used valve boards are the following: 2x Valve_1-5 2x Valve_6-12 2x Valve_13-18 2x Valve_19-22

4 valves are not used, and thus not installed. Valve coils are not installed on valve driver boards behind either. Note: Valves can be replaced individually, also the coils can be unsoldered and replaced but valve board cannot be replaced individually. We only provide the whole valve assembly 40 valves as a spare part.

21

Hemolyzer 5 3.3.2

WBC/BASO Preheater Assembly WBC/BASO preheater assembly

The WBC/Baso preheater assembly is located on the right side of the impedance measurement block, near the WBC/BASO counting chamber. It consists of two stainless steel holding plates, thermal insulation, heater block (see illustration below) and electronic board with heating transistors.

Thermostated on 36-37 °C and its function is to heat the WBC/BASO dilution for better lysing. Diluted blood and lyse reagent is pushed through the tubing of the heater block, diluent used for rinsing and cleaning the chamber also passes through this assembly thus the chamber itself is warmer than the ambient temperature.

3.3.3

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 instruments there are two cell-counter chambers: separate for RBC and WBC. In the RBC chamber the instruments counts red blood cells, and uses no lyse at all in this chamber. It has a smaller draining outlet made of plastic and its measuring tube contains a 70 µm-sized aperture. In the WBC chamber the instrument counts all kind of WBC. It has a measuring tube with an aperture size of 80 µm and a bigger draining outlet made of PTFE (Teflon).

22

Servicemanual Both chambers have a reference electrode and a draining outlet. The next picture shows the chambers and the measuring tubes. The aperture is made of ruby and it is molded into the measuring tube.

RBC chamber

Reference electrode

WBC chamber

Reference electrode

RBC measuring tube with the aperture (70µm) (no grooving)

WBC measuring tube with the aperture (80µm) (1 grooving)

Aperture

O-ring

3.3.4

HGB Measuring Head

Hemoglobin head is placed around the WBC measuring chamber in the instrument. It contains: a 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 COMB card. TSL235

LED

Connection to the amplifier

The analyzer performs enhanced Hemoglobin measurement technology for HGB

23

Hemolyzer 5 measurement. The output of HGB head is frequency (TSL235 detector is light to frequency converter). A digital counter in the FPGA circuit counts this signal. This counter counts up while the LED is on and counts down while the LED is off, the LED and the counter directions are switched with a 250 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 measurements: • Sample measurement • Diluent measurement

(before RBC counting) (in WBC washing phase)

The HGB result is calculated from these measurements by: HGB ≅ log (CNTdiluent light / CNTsample light) Due to backlight correction, Hemolyzer 5 is less sensitive to incident light changes.

3.3.5

Cell counter Amplifier Board

Amplifier board includes its own voltage regulators, connection interfaces to HGB head, to high voltage board and to LSDACQ board. There is a current generator circuit on this board, which works from 50V measuring voltage (generated by the High Voltage Board) and the probe voltage (DC) is amplified with a voltage follower (output: ELV). Nominal measuring current is 870 µA. Connection to: CSA1 on COMB Connection to: HVB

Connection to: COMB (DIGIO)

24

Servicemanual

Connection to the electrodes Offset potentiometer

Connection to HGB head

Amplifier board includes one input connector for each measuring chamber (measuring electrode). 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 Q1, Q2 FETs) for checking proper operation of each amplifier channel. Amplifier board includes a 3-stage main amplifier channel, which gains input signal to the 0...5 V range (this is the input range of the A/D converter (IC10), which is placed on the LSDACQ card). The RSW signal (with Q8 transistor) changes the input electrode through REL2 relay. There is an offset potentiometer, P1 in the third amplifier stage, manufacturer sets the correct offset voltage. The Amplifier offset adjusted automatically by the SW. The service personnel can adjust it manually by giving the offset value through the SW in service menu. If the auto offset is

cannot put the value in range the amplifier board is defective needs to be replaced.

3.3.6

Pressure sensor board 1

2

3

The Pressure Sensor Board incorporates three differential pressure sensors. The pressure values are read out by the LS-DACQ card through I2C interface. The sesors are responsible for reading pressures of:

25

Hemolyzer 5 (1) vacuum for impedance count (“chamber”) (2) vacuum used for draining chambers (“drain”) (3) big puffer vacuum for optical aspiration (“big puffer”) Upon replacing the pressure meter board, it is recommended to adjust pressure meter offset Hemolyzer 5 is equipped with sensitive pressure meters. These pressure meters are used to monitor and control measurement, and chamber draining processes. In some cases, the pressure meters can develop an offset value that can cause “Timeout” or “Chamber draining” errors. The new analyzer software can compensate for this offset value drift. Locate the “Start adjustment” button in the lower part of the screen – and tap it. The SW will perform a process, where the pressure meters will be “vented” to atmospheric pressure – and this value will be noted by the SW. This will minimize the occurrence of the “Timeout” or “draining” related errors. (On the screen you will see the actual value of the pressure meter, corrected values can be seen only if a Self-test is performed after the adjustments). If the above process fails… 1. Perform a Low Level Reboot (service menu, service functions) to get low level PC in a default known state 2. Run Test Function 11 3. Low Level Reboot 2 times 4. Perform Pressure Sensor Offset function (Service Menu, Adjustments) 5. Perform a 3-measurements based Calibration using normal level control blood

3.3.7

Reagent and Vacuum buffers

The lower part of the assembly plate holds six plastic cylinders, called chambers or buffers. The last one (marked as ‘1’ in the image) holds vacuum used in the optical measurement

26

Servicemanual process (for moving the solution). This vacuum is always adjusted according to measured atmospheric pressure. The four next chambers are used as temporary storage volumes for individual reagents for one measurement cycle. The first two (in the front, marked as ‘5-6’ are linked in parallel to double the capacity. Chambers 2-5 have internal floating (magnetic) level sensors. The volume of chambers 2-6 allow one measurement cycle to be performed after the reagent low warning.

3.3.8

Reagent Sensor Board

The Reagent Sensor Board monitors the liquid level in the reagent puffers continuously. If the liquid level too high (puffer full), it signals to the PPB2 board and the software can stop the filling process.

3.3.9

Opening the valve assembly plate

The plate holding the valves and the measurement block can be folded out of the analyzer. The plate is secured with 2 screws, similar to the ones securing the side panels. The screws are designed to stay on the analyzer to avoid losing them.

3.3.10 Vacuum buffer The glass chamber is located on the internal side of the assembly plate, and is used to store the vacuum for the optical measurements.

27

Hemolyzer 5 3.3.11 Pneumatic and Power Boards (PPB1 and PPB2)

PPB card contains the main power regulator circuits, valve and motor driver circuits and other connections for the fluidic and pneumatic system’s parts. Power system generates +5V (Digital power), +8V (Printer power) and +12V (Motor and valve power) from the single +12V DC input signal. Motor driver part consists of six separated PIC micro-controllers with power drivers. Horizontal, Vertical and Sample rotor motors have one combined ribbon cable connection. Main Dilutor (with two motors) and Micro-dilutor have separated connectors. Valve driver section is based on the valve driver PIC micro-controller and three 8-bit, powered output shift registers (with built in protection diodes) and there are two common ribbon cable connections for the 4 valve boards. The pump assembly has a separated Darlington driver circuit for more reliable operation. All microcontrollers have 2 LEDs: a yellow one and a green one. The yellow one indicates motor moving or holding and active valve or pump moving. (it means current flows into motors, valves or pump) The green one has 3 states: •

dark: (after initialization phase) error state,

28

Servicemanual •

blinking: communication in progress - normal state

•

on (just lighting): OK - normal state

PPB boards have a small board on the bottom called PPB CON board. This board connects the PPB to the LSDACQ board.

3.3.12 Pump assembly Pump assembly generates regulated vacuum and drains the fluidic system. There are two pumps in the system. They are connected to the two PPB boards.

For further information see chapter 11.9.

29

Hemolyzer 5

3.4 Right side 3.4.1

XY unit

This unit contains slides to move the sample sampling needle in Horizontal and Vertical directions, two stepper motors, XYR opto board, opto wheel, washing head and the sampling needle. It moves the needle to the desired position: from sampling position, to washing head, and by means of the washing head it press the sample tube during the sampling process.

Both stepper motors have optical end-switch sensors for detecting these positions. These are required for correct initialization and error detection. All sensors have status LEDs to show actual conditions. The Vertical motor works with a special opto wheel for detecting home & end positions. See the Adjustment section of this manual to place this wheel to the proper position. Greasing of the horizontal/vertical guiding rods should be done regularly using photolube A598. It is recommended to check and repeat greasing of guiding rods every year, or after 30000 measurements. See section 6.1.1.1.

30

Servicemanual 3.4.2

XYROpto Board

Horizontal and Vertical motors and the Sample Rotor unit have a common Opto-board. Sample Rotor opto

Horizontal opto sensors

Horizontal status LEDs

Motor connections

Vertical status LEDs

Vertical opto sensors

The other (rear) side of the board contains the connection for the Sample rotor and a ribbon cable connection to PPB#

3.4.3

Sampling needle

Sampling needle is assembled in the H&V moving unit and it makes the piercing and the sample aspirations. Correct setting of sampling needle is necessary and very important (see Chapter 6. Adjustments). Be careful, the needle is very sharp and it can cause injury!

3.4.4

Blood sensor

Blood detector is a component that will allow determining if the sampling process was successful. It is measuring the length of the sample. If the sample is found short, a “sampling error” is going to be displayed. It also has an emergency mode in case the blood detector failed. In this case, the analyzer is not going to consider blood detector data, but it will move the sample to a predefined position. Both parts of the sampling control must be adjusted.

31

Hemolyzer 5 3.4.5

Wash head

Wash head is located at the bottom of the XY 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. Replace washing according Preventive Maintenance procedure .

3.4.6

Processor unit (LS-DACQ board with DimmBoard)

The LS-DACQ board is based on a credit card size embedded PC (DimmBoard). The LSDACQ implements the following functions: -

Receiving commands from the Analytical Unit, Blood sampling and sample handling control, Motor and valve control, Measurements control, Amplifying and A/D converting of 4 input channels simultaneously, Data preprocessing, Transmitting data to the Analytical Unit, Interfacing the Laser Driver and the TCU, Interfacing the Start Button and Status LEDs,

The LSDACQ board incorporates a credit-card sized PC, named DimmBoard. The processor on the DimmBoard is a 600MHz Pentium-class core, with 256Mbytes on-board RAM, and SD card controller. This SD card contains the Low Level SW of the system which

32

Servicemanual handles all the measuring processes. The Low level SW can be updated from the service software update menu.

Flash (BIOS)

Vortex86DX CPU

Edge MicroSD Card Flash (BIOS)

FPGA interface The FPGA is connected through the ISA bus of the DimmBoard. The FPGA implements several registers, and the DimmBoard can reach these registers as memory-mapped. Buffer memory During optical measurement, a vast amount of data has to be transferred to the Analytical Unit through the USB connection. It is necessary to use a buffer memory to store the data temporarily, because the USB transfer speed may not be enough to transfer the data realtime. The LS-DACQ uses a 2 MB SRAM memory as buffer. The SRAM is organized as FIFO (first-in first-out memory). Connection with the Analytical Unit The Analytical Unit is connected to the Data Acquisition System by a full-speed USB interface. The USB interface is implemented by a FT2232L USB chip. The USB chip implements 2 channels, one of them works as a virtual COM port, the other is a parallel data channel. The VCOM channel is used as a command channel, through which the Analytical

33

Hemolyzer 5 Unit sends commands to the Data Acquisition System. The measurement data are sent to the Analytical Unit through the parallel data channel. FPGA The FPGA is a Xilinx Spartan II type. The FPGA preprocesses the digitized data of the optical measurement and sends them to the Analytical Unit through the USB. It preprocesses the volumetric impedance measurement data too, produces data packets, and sends them to the Analytical unit. FPGA controls the SRAM, to make a FIFO data buffer of it. Implements an I2C interface to control the PPB (Pneumatic and Power Board) boards. Implements a MDA display for service purposes. FPGA configuration As the FPGA is SRAM based, it is configured after every power on. The program is stored in a Xilinx configuration flash memory. The flash memory can be programmed through a JTAG port by a Xilinx Parallel Cable or in-circuit from the Hemolyzer 5 program. Analog inputs The LS-DACQ has 4 analog inputs (AIN0-AIN3). AIN0 and AIN1 for the 2 channel optical measurement, AIN2 is for the auto alignment, AIN3 is for the volumetric impedance measurement. The input signal range for AIN0 and AIN1 is 1V..+3V, the DC offset is programmable, to adapt it to the A/D converter’s input level of +1.5V..+3.5V. The input signal range for AIN2 and AIN3 is 0V..+5V, and the gain is programmable. A/D converter The A/D converter is a THS1007 type, four channel A/D, manufactured by Texas. The input voltage level is +1.5V..+3.5V, so AIN0 and AIN1 can be connected after DC level setting, but AIN2 and AIN3 channels require not only level conversion, but attenuation. The input amplifier and level converter perform these functions. The sampling frequency is 1 MHz on all input channels. Temperature and Power Voltage Measurement, I2C Interfaces The LS-DACQ card incorporates a PIC microcontroller that is connected to the DimmBoard through the FPGA. The PIC with a built-in I2C controller controls the Laser Driver Board, the Opto Sensor Board, the Pressure board and the TCU. The PIC measures the board temperature and there is an input for measuring an external temperature. The PIC measures the board power voltages and the DimmBoard battery voltage. Connectors POWER Connector The LS-DACQ board is powered directly by the PC power supply through a standard IDE power connector. It supplies the board with +5V and +12V.

34

Servicemanual Power voltages on the LS-DACQ board: +12V – Provides +12V to the Cell Counter Amplifier board (AJ5-MEAS), Pin Photodiode and Amplifier board (OPTSENSOR), High Voltage Board (AJ-HVB) and the Laser Driver board (LASERDRV). -12V – Generated by a DC-DC converter. Not used on the LS-DACQ, output to the Cell Counter Amplifier board (AJ5-MEAS) and the Pin Photodiode and Amplifier board (OPTSENSOR). +5V – Supply voltage to the DimmBoard, and to some other logic. +3V3 – It is generated from the +5V by a low dropout voltage regulator. Supply voltage to the 3.3V logic, among them to the FPGA IO pins. +2V5 – It is generated from the +5V by a low dropout voltage regulator. FPGA core voltage. PPB Connector The PPB connector connects the 2 Pneumatic and Power Boards (PPB) to the LS-DACQ board. DIGIT IO Connector The Cell Counter Amplifier board (AJ5-MEAS) is connected to the LS-DACQ board through the DIGIT IO Connector. HVB Connector The HVB connector connects the High Voltage Board (AJ-HVB). ANALOG INPUT Connector The ANALOG INPUT connector connects the Pin Photodiode and Amplifier board (OPTSENSOR) to the LS-DACQ board. AINCH2 Connector The AINCH2 connector is not used in the actual design. AINCH3 Connector The AINCH3 connector connects the analog output of the Cell Counter Amplifier board (AJ5MEAS) to the LS-DACQ board. XILINX JTAG Connector (not used on the field) The FPGA configuration flash memory can be programmed through this connector by a Xilix Parallel Cable. DEBUG DISPLAY Connector (not used on the field) Only for test and debug purposes. LASER DRIVER Connector

35

Hemolyzer 5 The LS-DACQ board provides power and an I2C interface to the LASERDRV board through the LASER DRIVER connector. PRESSURE Connector The LS-DACQ board provides power and an I2C interface to the PRESSMEAS board through the PRESSURE connector. TCU Connector The LS-DACQ board provides an I2C interface to the TEMPCTRL board through the TCU connector. As the TCU requires high current power, the TCU is powered directly by an IDE connector of the PC power supply. FRONT PANEL Connector The FRONT PANEL connector connects the Front Panel board (STARTBUT) to the LSDACQ board. FLOPPY Connector A standard 3.5” floppy drive can be connected. It is used only for test and debug purposes. KEYBOARD Connector A standard PS2 keyboard can be connected to the DimmBoard’s keyboard interface by this connector. It is used only for test and debug purposes. COM1 Connector The DimmBoard’s COM1 port is output here. The Auto Sampler is connected to this port.

NTC TEMP Connector An external temperature measuring NTC resistor can be connected, to measure external temperature. USBA Connector The DimmBoard’s USB upstream port is output here. It can be used for DimmBoard software upgrade. USBB2 Connector It is connected to the USB downstream port of the PIC microcontroller. Not used. USBB1 Connector It is the USB interface between the Data Acquisition System and the Analytical System. It is an USB downstream connector.

36

Servicemanual 3.4.7

Mini-ITX PC mother board (In Hardware block)

1. PS/2 mouse port (green). This port is for a PS/2 mouse. 2. Serial connector. This 9-pin COM1 port is for serial devices. 3. DVI connector. This 24-pin DVI port connects to a DVI monitor. 4 & 5. LAN (RJ-45) port. This port allows Gigabit connection to a Local Area Network (LAN) through a network hub. 6. Line In port (light blue). This port connects a tape, CD, DVD player, or other audio sources. 7. Line Out port (lime). This port connects a headphone or a speaker. In 4-channel, 6channel, and 8-channel configuration, the function of this port becomes Front Speaker Out. 8. Microphone port (pink). This port connects a microphone. 9. USB 2.0 ports 3 and 4. These two 4-pin Universal Serial Bus (USB) ports are available for connecting USB 2.0 devices. 10. USB 2.0 ports 1 and 2. These two 4-pin Universal Serial Bus (USB) ports are available for connecting USB 2.0 devices. 11. VGA port. This 15-pin VGA port connects to a VGA monitor. 12. Serial connector. This 9-pin COM2 port is for serial devices. 13. PS/2 keyboard port (purple). This port is for a PS/2 keyboard.

37

Hemolyzer 5

4 Electronic block diagram The analyzer hardware consists of two systems, an Analytical Unit and a Data Acquisition Unit. The two autonomous systems communicate via an USB interface. A 400W ATX PC power supply generates the necessary voltages for the two units.

4.1 Hardware Block The function of the Analytical Unit is to implement the user interface, to start and control the measurement processes, to receive and process the measurement data, handle the database, display, store, and print the processed measurement data. Hardware Block is responsible to communicate with the user, transfer data to the Low Level Software and store the settings and measured data. The components of the Analytical Unit are: -

PC mainboard (mini-ITX mainboard).

-

Mass storage device (250 GB Winchester)

-

Power supply (400W)

-

Audio amplifier and speaker

-

Keyboard (optional)

-

Mouse (optional)

-

USB CD/DVD drive (optional)

-

Mainboard back panel I/O ports

-

LVDS cable

-

Touch cable

-

Internal USB cable

-

LED display cable

38

Servicemanual

10.4” LCDLED 600x800

Data and Power connector

Touch screen connector

Touch screen USB interface board

Back light connector

Power supply

USB

Power & Video

Power supply connector

Mini-ITX main board

PS2 Keyboard

Keyboard

PS2 Mouse

Mouse optional

IDE

4 USB

3.5” 250GB HDD

CD-DVD or other eternal device like printer (optional)

optional

Audio

USB

Audio amplifier board

Speaker

Data acquisition system

39

Hemolyzer 5

4.2 Data Acquisition Unit This unit executes the commands of the Analytical Unit. It controls all the processes of the sampling, sample actuation, motor and valve control, measurement control and the data acquisition. It preprocesses the raw sampled data and forwards it to the analytical unit. The components controlled by the Data Acquisition Unit are: -

Laser diode driver and diode

-

PIN photodiode and amplifier

-

Cell counter amplifier and HGB head

-

High voltage board (HVB)

-

Pressure sensor

-

TCU (Temperature Control Unit)

-

2 PPB boards (Pneumatic and Power Board)

-

Stepper motor units with opto boards (dilutors, X-Y module, shear valve)

-

40 Valves

-

2 Pumps

-

Reagent sensor board

See Data Acquisition “map” on the next page:

40

I2C

PPBIF (I2C)

PPB1

Analog connector

Cell counter amplifier

chamber + electrode

Parallel port

HVB board

I2C

Pressure sensor

I2C

TCU

Analog connector

COM1

Laser driver + laser diode Optical measurement

USBB

Start Button Connector

Autosampler (optional)

HW block Start Button + LEDs

41

+50V +150V

Pin photo diode + amplifier

Laser driver connector

USBA PS2 keyboard

HGB head

HVB connector

DimmBoard

Reagent Sensor

Impedance measurement

DIGITIO connector

Floppy IF Debug

Shear Valve

PPB2

I2C

LS-DACQ board

JTAG connector (FW

Dilutor 2

Auto Alignment

Pump2

34-37 valves

17-22 valves

38-44 valves

12-16 valves

Dilutor1

X-Y module

Pump1

23-26 valves

6-11 valves

1-5 valves

27-33 valves

Servicemanual

Hemolyzer 5

4.3 Amplifier board This unit is responsible to gather information during impedance measurements. The amplifier board receives the signal of cells gathered by the aperture and gains these analog signals before transferring it to the LSDACQ.

The amplifier is using 50V DC for measurement and 150V DC for cleaning apertures. These voltages are generated by the HVB (High Voltage Board). Amplifier unit has a test function. Test generator switches pulses to the input of operation amplifiers during the automated Self-test program. HGB signals are distributed by Amplifier unit.

42

Servicemanual

4.4 Optical Head Optical head provide WBC differential result applying a hydrodynamic focused flow cell, a laser light, light detectors and amplifiers to gain the detector signals. The laser driver unit has two Safety switches on the Laser head cover fixing to turn off the laser light when the cover is removed. For safety reason the laser diode remains off until the low level system or the whole system is rebooted. Three analog signals are provided on the output of Laser Amplifier board. The low angle is typical of the size of white blood cells, the high angle is typical of the size of the cell complexity, DC is dependent on of cleanness flow cell.

43

Hemolyzer 5

5 OPERATION OF THE FLUIDIC SYSTEM This section describes the main fluidic steps of Hemolyzer 5 measurement cycle. The following figures show total measurement flow diagram and detailed descriptions of processes for understanding the fluidic system work. In Hemolyzer 5 the cleaning process executed parallel to the measures and the standby process are executed in the background. It means that the database and other functions (except pneumatic) are accessible while the analyzer is performing the measurement cycle and while it is going to standby. The cleaning process does not block the next measurement cycle, so after getting the results the next measurement can be started.

5.1 The Reagent system Name Hemolyzer-Diluent

Hemolyzer-5-Lyser

Hemolyzer-5-Diff 5P

Hemolyzer-Hypocleaner

Description Isotonic solution, used to dilute whole blood and quantitative and qualitative determination of RBC, WBC, PLT and HGB concentration Reagent for stromatolysis of RBC and quantitative determination of WBC 5part differentiation (LYM, MON, NEU, EOS, BAS) and HGB concentration measurement of human blood. Quantitative determination of leukocyte five-part differentiation (LYM, MON, NEU, EOS, BAS) Capillaries, tubing and chambers, removing blood component precipitates.

44

Function dilution of sample, rinsing and cleaning the tubing system; it is the sheath fluidic BASO and 4-part (LYM, MON, NEU, EOS) lysing

responsible for timed 4Diff reaction Cleaning system (external liquid, not part of standard reagent system)

Servicemanual

5.2

Flow diagram of measurement

START BLANK

START Meas.

Needle to SR

Sample in

Needle piercing

Cleaning processes Generating Vacuums

Sampling Needle washing (outside)

Preparing for making dilutions HGB blank

SV to CP

Generating Vacuums

Dilutions in parallel WBC, MIX, 4diff

Needle Prewashing (Inside)

SV to NP

Making RBC dilution SV means Sample

SV to CP

45

Note: CP means “Chamber Position”; NP means “Needle Position”; Shear Valve; SR means Rotor

Hemolyzer 5

Cleaning Needle (Inside)

Making 4diff dilution +

RBC measurement

refilling sheath puffer Generating vacuum

4diff measurement

Regenerate vacuum

SV to NP

HGB measurement + reset vacuum

Cleaning

WBC measurement

MIX, RBC chambers, TCU loops 1st time

Taking BASO sample

SV to CP

BASO measurement

RESULT

Cleaning WBC, RBC chambers TCU loops 2nd time

SV to NP

START NEXT

46

Servicemanual

5.3 Initialization of the Fluidic System Fluidic initialization process performs the following steps: •

Checking the hardware conditions of the unit.

•

Checking of pump and pressures sensor by generating measuring vacuum.

•

Positioning all mechanical components by scanning moving range (with endswitches).

•

Checking prime conditions of reagent buffers.

•

Cleaning of aperture with high-pressure back-flush and high-voltage burning.

•

Preparing for compulsory blank measurement.

5.4 Reagents priming Sample measurement or most of the fluidic functions is not available if the reagents are not fully primed. This can be done manually or automatically from the Maintenance menu, but the instrument also performs automatic priming in several points of the pneumatic functions. (e.g. starting fill-up process, Preparing for measurement, wake up…etc.) The fluidic system is connected to the reagent containers in a closed fluidic way. This means when a syringe is priming reagent from the internal reagent reservoirs, the generated vacuum will automatically fill them up when the floating sensors detects low liquid level. Hereby the priming of the reagent during the measurement is automatically. During measurement the system automatically double-check the reagent levels in the buffers, and notice the user at the end of that measurement, if any of the reagents are running low and replacement is needed.

5.5 Piercing process After the Start Button was pressed and all of the necessary initializations had done, the measurement cycle starts with the piercing process. The Sample rotor immediately turns in; the needle comes forward and starts to pierce the sample.

5.6 Sampling process When the needle reaches the sampling position, a dilutor syringe takes out 100µl of blood. The blood sample is separated from the diluent by air bubble. The air bubble was taken right after the needle washing process of the previous measurement or during the preparing for measurement or wake-up processes. When the needle is pulled out of the sample tube and washed by the wash-head from outside, the primary blood sample will be transferred into the Shear Valve loops.

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Hemolyzer 5

5.7 Needle washing processes When the primary sample is taken out, the needle will be washed outside by the wash-head using diluent and continuous drawing. During Diluting process, the needle will be washed through twice. First a preliminary flow of diluent slowly washes out the remnant of the whole blood into the washing head. Finally 2,5ml of diluent cleans out the needle with high speed. When the needle is clean, the system will take air bubble into the end of the needle preparing for the next sampling.

5.8

Diluting processes

After the primary blood sample was taken out and transferred to the first 3 SV loops, the SV rotates to Chamber Position (CP). The loops in the SV counting from the needle side are: 1st – WBC (~16μl)

2nd – MIX (~16μl)

3rd – 4diff (~40μl)

||

4th – RBC (~16μl)

4-diff has a special loop; it is transparent and has higher volume. The system makes the first step of RBC dilution, WBC dilution and 4diff pre-dilution in parallel. WBC dilution is made by 2.5 ml mixture of diluent and lyse. The concentration of the lysing mixture is approx. 1:4. The WBC dilution is mixed with air bubbles from the bottom of the WBC chamber. During 4-diff pre-dilution the primary blood sample is forwarded with diluent into the TCU to preset of the required temperature. The first step of RBC dilution made by 2.2 ml of diluent and mixed with air bubbling from the bottom and the side connector of the Mix chamber. When the mix dilution is ready, a dilutor syringe moves the mix sample through the SV into the 4th sampling loop. Then the SV rotates back to Needle Position (NP). The RBC dilution is made in the RBC chamber with 2.5ml of diluent and mixed with air bubbling from the bottom.

5.9 Lysing process The dilution for the WBC and optical BASO count is the same. The WBCs are shrink by the quick lyse reagent to its nucleus except the BASOPHILES. After the sample dilution measured in impedance way, the remaining sample is transferred to the optical head for basophile count. More complex lysing process is made on the 4diff dilution. It requires precise timing, volume control and temperature conditions. The accurate temperature control is made by the TCU module.

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Servicemanual In the TCU unit, there are loops for lyse, stopper, blood + lyse, pre-diluted blood mixture. Temperature of these loops is controlled accurately. After the 4-diff primer sample is pre-diluted and its temperature has been set, 3 syringes (lyse, stop, diluent) make the precise dilution through the TCU unit, the Shear Valve 4-diff sample loop, ending in the big vacuum puffer. Previously generated vacuum supports the smooth flow of the mixture. The pre-diluted blood meets with the lysing reagent by a small “T” connector first. Right after this point there is an inline mixer part in the TCU module, where the blood and lyse is mixed in its tube by flowing through. After that the precisely mixed lysing dilution runs through one of the TCU heater loops for better temperature conditions, and reaches the stopper “T” connector. The volume between lyse and stopper “T” connectors is about 1ml, and this is the incubation zone for the lysing. After adding the stopper reagent the mixture goes through another inline mixer, the SV 4-diff sampler loop, and flows into the vacuum puffer. The SV 4diff sampler loop is volumetrically set by the software, so the precisely lysed and stabilized 4diff mixture will be stopped in this loop, ready for measurement. The parameters of the lysing process are the temperature of the dilution, the dilution ratios of the blood-diluent-lyse-stopper mixture and the speed of the flow. These are determining the quality of the 4diff dilution.

5.10 RBC counting process The regulated vacuum aspirates RBC dilution (RBC) from the RBC chamber through the aperture. The instrument counts the cells for 10 seconds in this case.

5.11 WBC/BASO counting The regulated vacuum aspirates the WBC dilution from the WBC chamber through the aperture. The instrument counts the cells for 10 seconds in this case. After the WBC dilution has measured in capillary mode, the system transfers the remnant of the sample to the BASO loop in the Shear Valve. The last parameter in measurement cycle is the optical BASO count. The BASO count is measured by the optical head as like the 4-diff measurement.

5.12 WBC 4Diff counting The regulated vacuum aspirates the WBC 4diff dilution and the sheath fluid from Sheath puffer, through parallel tubes (one for sheath flow, one for sample flow), through the flow-cell into the vacuum chamber. The instrument counts the cells for 6 seconds in this case. During measurement the core diameter of the sample stream in the flow-cell is approx. 250µm. This is determined by the tube resistance ratio between the sheath and the sampling lines. A self-cleaning process is started after the 4-diff measurement ends. The system changes the insertion point of the vacuum, which starts to wash back the sampler needle and the 4diff

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Hemolyzer 5 sample loop in the Shear Valve with sheath fluid. This process prepares the optical head for the following BASO count.

5.13 Chamber draining processes Chamber draining is made by a special pressure control. Pressure controlled draining starts with vacuum generation in the puffer reservoir. The liquid aspirated from the chambers while buffer reservoir and thus the pressure sensor is monitored in the draining tube. The instrument can detect the empty state of the chamber by drop of vacuum. Error message is send if the vacuum loss was not detected indicating the measuring chamber draining procedure was failed.

5.14 Cleaning (rinsing) processes All cleaning processes during a measurement cycle uses mainly diluent, and for special cases small volume of lyse, and stopper reagent (e.g.: cleaning the adequate loops in the TCU). The instrument performs the cleaning processes parallel to the measurement. When any of the fluidic part has finished its work with the whole or diluted blood, cleaning process will start. The main cleaning processes during measurement are: -

Needle washing outside, 2x inside into washing head

-

Mix chamber washing

-

RBC, WBC chamber washing, back flush and high voltage burn of apertures

-

4diff diluting loop (Shear Valve + TCU loops) washing

-

Optical head and sampling line washing with sheath fluid

5.15 Standby process Because of the high throughput of the Hemolyzer 5, the measuring cycle ends with empty WBC chamber, and leaves the BASO sampling line is not cleaned. During continuous measurement the beginning of the next measurement will automatically clean this loop. Avoiding the BASO loop contamination the liquid is aspirated automatically from it two minutes after the last measurement of a sample batch. However, when there is no more measurement started, the instrument will go to stand-by mode after some minutes. Standby process performs cleaning, drains all vacuum chambers, drains all chambers then refill them with diluent just above aperture level.

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Servicemanual

5.16 Wake up process In this case the instrument prepares itself for the upcoming measurement cycle. Cleaning the wash head and calibrating the blood sensor.

5.17 Shutdown process The fluidic shutdown performs the following steps: -

Priming chambers with diluent to avoid drying out of aperture and prevent the chamber from contamination.

-

Needle is in up position and washed.

-

All of the syringes are positioned down.

-

Sample rotor moved out

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Hemolyzer 5

6 ADJUSTMENTS For proper functioning, it is vital to adjust the system correctly. Although Analyticon production sets the system in house, sometimes these adjustments needs to be done on the field also. Both mechanical and software adjustments has to be done properly to avoid measurement results or pneumatic errors. Please note that the lifetime of the mechanics system is long. If there's a problem with the mechanical system, most cases a proper adjustment is enough to solve the problem.

6.1 XY unit mechanical adjustments The XY unit has 4 critical parts to adjust. These 4 adjustments can be done separately, but some of them can affect other settings. See the 4 attributes of the XY unit which has to be set properly: •

XY (needle) horizontal movement

•

XY (needle) vertical movement

•

Needle position

•

Washing head position

If any of these four attributions are not set correctly, the system can stop with a pneumatic error or give improper results. These adjustments can be tested in Service testing menu. The movements of the XY unit made from Service testing menu are slower than normally. Some cases the improper hardware settings are not appear during the movement used by Service testing menu. To make sure that the mechanical part is working properly, the system has to make an Initialization process (hardware init). This process moves the mechanical part (XY) faster, highlighting the problems made by the faulty settings or misalignments. Hardware init can be done in Service functions screen or the system is making an automatic init process, after e.g. Washing head setting process is finished. Use these functions to check mechanical settings also.

6.1.1

XY horizontal movement

The proper horizontal movement is important to make sampling from the Sample rotor and from the Auto-Sampler. The horizontal movement of the XY unit is made by one of the stepping motors and positioned by two separate opto flags. The Front and Rear positions are defined by the settings of these opto flags. The XY unit is moving on metal rods. These rods have to be greased after a period of time.

6.1.1.1 Greasing the horizontal rods There are 2 horizontal rods in the XY which is responsible for proper and smooth movement of the needle and the needle holding block. These rods are cylinder shaped. They have a fix position in both the front wall and rear metal block in the XY. The rods are not fixed tight, they're loose and can wobble to move together with the needle block.

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Servicemanual The third rod is squire shaped and responsible to hold the vertical belt for the needle. The front of this rod is not fixed in a metal block, it “hangs” free.

Guide

Square shaped rod Guide rod

Test the movement of the needle to Front or Rear positions in Service testing menu. If there is any grinding noise because of the improper lubrication, these three rods has to be lubricated. Name (and part number) of the lubricant: Photolube 022 (A598)

6.1.1.2 Set opto flags for horizontal movement If the XY unit hits the front wall of the mechanics (Front position, above the sample rotor) or stops in a non centered position above the Auto-Sampler docking station (Rear position). Use a hexagon 2.0 mm screw to loose the fixing screws holding the opto flags. Align them to make the XY horizontal movement stop earlier or later, depending on the actual state of the flags.

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Hemolyzer 5

Opto flags

Opto LEDs

Opto

Fixing Front wall

Use handmade horizontal positioning of the needle, place the needle to the correct position, then align the opto flag to the opto sensor, see that the indication LEDs are turned on when the flag reached the sensor. When the needle reached the ‘Front’ position, the gap between the needle holding block and the front wall of the XY unit should be around 0.5 mm. When the needle reached the ‘Rear’ position, make sure that the two vertical rods -which are holding the washing head can push the tube holders to the correct position on the AutoSampler's docking station.

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Servicemanual

Needle holding block

Washing Washing head

AS docking

Tube

The opto sensors are fixed to the XY PCB and cannot be adjusted.

6.1.2

XY vertical adjustment

This setting is necessary for the vertical motor movements because this adjustment sets the opto end-switches of the XY unit.

6.1.2.1 Basic operation During testing the vertical movement of the XY, some strange noise can appear or maybe the vertical movement is not performed correctly and it's causing the pneumatic error. These problems can be found if we understand how the mechanics works. Find the opto wheel (black cogwheel) at the rear side of the XY unit. Note that the vertical opto sensors -next to the opto wheel- are using negative logics. The sensor is always triggered by the opto wheel, except when the small holes on the wheel reaches the sensors. These wholes indicates the Up and Down positions and the needle should stop when the wholes reaches the sensors. The opto LEDs are always on, except when the needle reaches the ‘Up’ or ‘Down’ positions. The opto wheel is connected to the vertical belt -by the middle square shape rod -and they are moving together. The needle is connected to the belt by two screws. If the opto wheel reaches the ‘Up’ or ‘Down’ position, the needle should also stop. The problem is that the mechanical structure of the XY is making the needle stop before the whole on the opto wheel is reaching the opto sensor. This can be happen in 'Down' position, because the needle mechanics is reaching the position earlier than the opto sensor gets the signal to stop. Or in 'Up' position, when the Washing head is already reached the highest

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Hemolyzer 5 position and hits the needle's vertical block, while the opto sensor still didn't received the 'Up' position signal.

6.1.2.2 Adjusting the needle’s vertical position The problem can be easily set by losing the two screws behind the needle and let the needle "release" the belt and fall down to "Down" position. Because the screws are loose, the opto wheel and the belt can move separately from the needle, the needle itself is down and not moving. Disengaged

Now the opto wheel can be set after the needle, which means the opto wheel should reach Down position. Press 'Down' in Service testing screen to move the opto wheel to 'Down' position. The needle is already in 'Down' position. When the opto wheel is in 'Down' position, tight the two screws which makes the needle "grap" the belt again. Now the vertical system is set together again, press 'Up' and 'Down' buttons in Service testing screen to see that the movements are proper. Test the movement with Init process also. Adjustment is successful if LEDs goes on before moving part reaches end of mechanical range. Changing the vertical position of the needle on the vertical belt can affect the position of the washing head and the needle. Please perform a needle and washing head setting after vertical position is set.

6.1.3

Washing head settings

The position of the washing head is critical for the system to make the sampling and needle washing correctly. The washing head contains two metal tubes to make the washing process. The bottom is the inlet for diluent to wash the needle from outside, the top is the outlet to aspirate the liquid from the needle to the waste. During the washing process, the system also pushes diluent to the needle from the shear valve, ensuring that the needle will be cleaned from the inside also. The relative position of the needle and the washing head is important to make the aspiration properly, otherwise the diluent from the needle will flow out from the bottom of the washing head. To set the Washing head’s position, go to Adjustments menu and press ‘Wash head’ button. The message will appear to confirm that the washing head setting process will start. Press

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Servicemanual ‘Ok’. The system will pull the needle and the washing head to Up position. Now the system holds the XY unit in the Up position until the setting is ready. The washing head is in position if the distance between the top of the head and the metal block above it is close to 1mm.

1 mm gap

This distance is not strict, but it’s enough to provide space for the washing head when the needle moves. If washing head’s position is higher, it can hit the metal block when it’s raised to Up position and it can hit the sample rotor and the tube holders if the position is too low. If the position is not correct and has to be set, find the two screws on the top of the XY unit. These two screws are holding the two rods of the washing head. Loosing these screws make the height settings enable.

1.5 hexagon screws to hold the washing head leading

2.0 hexagon screws to hold the needle

6.1.4

Needle setting

The height of the needle is important to make a good aspiration from the blood sample. The aspiration whole is on the side of the needle, but for height setting, we use the bottom end of the needle. This end of the needle is sharp, but during the procedure, there is no need to touch this part. For position checking, the needle can be moved by hand or by the software.

6.1.4.1 Handmade setting Manually push the needle to down position. Make sure that the needle is not hitting the sample rotor’s plate. Check that the needle is completely down, then take a look at the end of the needle. The distance between the sample rotor’s plate and the needle should be 1mm.

57

Hemolyzer 5 If the distance is not correct, find the two holding screws at the other end of the needle. Use a hexagon 2.0 mm tool to loose the screws and set the needle’s position. 1mm Note that when the needle is Down, the screws are covered by the mechanics of the XY. The needle has to be raised to have access to the screws.

The needle is sharp and it can cause injury! Always use gloves when needle setting is performed! Make sure that the whole on the needle is facing the sample rotor.

6.1.4.2 Software made setting In Adjustments menu, press ‘Needle’ button. The system will ask to confirm that the needle setting should start. Press ‘Ok’. The needle will move down and up. The software will ask to confirm that the end of the needle is visible at the bottom of the washing head. If the needle is not visible or it’s leaning out too much, loose the holding screws to adjust. If setting is ready, press ‘Ok’.

6.2 Shear valve mechanical setting This opto setting is necessary for the correct movement of the Shear Valve. Although the SV is stopped mechanically in its end positions, the opto sensors provide the necessary feedback signal for the electronics that the movement has been done. The setting of the mechanics and the opto sensors are made by Analyticon during production, sometimes these alignments has to be checked or realigned.

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Servicemanual 6.2.1

Shear valve lower disc position setting For adjusting the lower disc, remove the thumb screw and place the upper disc to a safe position on the mechanics under the optical head. The lower disc of the shear valve is positioned by two metal plates. Setting up the plate on the right side is Plate and disc connection critical.

The plate is fixed by to screws. This is the basic setting of the valve, if the disc is not fixed correctly, the amount of sample can be different during each measurement. The disc and the plate should connect in the full length of the connection surface. The disc shouldn’t wobble or move. If the setting of the disc is not proper, loosening the two screws on the bottom and realigning the connection between the plate and the disc should be the first step. This setting should be set with a hexagon 2.5 mm screwdriver. The two connection surface should be parallel. When the lower disc is aligned, make sure about the following: • the disc position is horizontal • the plate fixing screws are tight • the sides are parallel • the disc meets the plate with full surface • the lower disc cannot move

While making an alignment and the shear valve is disassembled, make sure that the internal surface of the ceramics is clean, not scratched. If the plate and disc is aligned make sure that the second plate on the left side is pushed to the disc. This plate ensures that the shear valve will not move away from the aligning plate. After the lower disc is aligned, replace the upper disc and fix the thumb screw back to position.

6.2.2

Shear valve upper disc setting

The upper disc and the mechanical stoppers (bumpers) are aligned by Analyticon during QC and End of Line procedures. If this setting is compromised, the mechanics should be aligned

59

Hemolyzer 5 again. To have access to the mechanical stoppers, the metal cover of the shear valve should be removed. The cover is fixed to its place by the two inner screws behind the thumb screw. The shear valve’s task is to change position to guide the sample and the reagents to the correct direction. For this, the tubes should be perfectly aligned which means that the mechanics should stop the turning of the discs in a correct position.

Bumper fixing

Shear valve upper

Plates holding the

The mechanic part is designed to change the motor’s circular motion to horizontal motion. There is a horizontal drive behind the ceramic disc which can be shifted left or right by the stepping motor.

Horizontal

Shear valve moving

Mechanical stoppers

This rod has two nodes which are surrounding and moving the upper disc’s rod. This is how the disk is moving. The nodes can reach a stopping mechanic block on both sides of the mechanics. If nodes hit the stoppers, the turning of the shear valve will stop. When the shear valve is stopped, the small metal tubes on the upper and lower discs should be perfectly aligned to each other. The shear valve has a free hole on the edge of each ceramics. This hole is not connected to the tubing system and it’s easy to access. There is no special tool to check shear valve alignment; a simple paper clip is enough to check the alignment in both positions. The paper clip should access both holes on the ceramics. During the test, make sure the shear valve reached to bumper and cannot turn more.

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Servicemanual The paper clip has a size and straight part just enough to push through the ceramics.

Opto Opto Paper clip in alignment Alignment

The lower disc has two holes to test both positions. Test one position at a time. If the paper clip can go through both discs, it means the shear valve is in position. If the paper clip cannot go through the holes the upper discs position has to be realigned. The bummer fixing screw should be loose to make the bumper move free. Find the correct position where the paper clip fits into both holes. If the position is ok, push the bumper to position until it hits the node of the drive. If the positions are set, the bumpers have to be fixed again by tightening the screw. Note that the shear valve needs to be pushed to the other position to have access to the bumper fixing screws. Remove the paper clip to turn the shear valve with the horizontal drive. Use the paper clip to see alignments in both positions (CP, NP). Make sure that the bumper holding screws are well tight.

6.2.3

Setting the opto sensors of the shear valve.

There are two opto sensors for the shear valve to sense when the ceramics reached their positions. The upper disc has a rod called the opto rod. This rod moves inside the opto sensors when the shear valve is turned. The sensor should give the signal to the software to stop the motor because the positioning of the shear valve is done. The opto sensors are placed on a PCB called Shear Valve OPTO (SVOPTO). The sensors can be positioned separately; it doesn’t need to align both if only one sensor is misaligned. Shear valve

SVOPTO

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Hemolyzer 5 The sensors are connected to a LED, which turn on when the sensors are triggered. Use these LED to check alignment. Turn the shear valve clockwise to the outer (chamber) position. Make sure that the shear valve is in the maximal position and cannot turn more. Put the paper clip to the alignment hole. It should access both holes easily. The outer sensor’s LED should be turned on in this position. Check that the LED is on, position the LED PCB if it’s needed. Use hexagon 2.5 mm screwdriver. If the sensor is in position and the LED is on, try to turn the shear valve counter-clockwise. Because the paper clip is in the alignment holes, the shear valve will only turn in a very small amount. Find the maximum position until the paper clip lets the shear valve turn. In this position, the LED should be still on. Make sure that the LED is on and set the SVOPTO to make the LED light again. Remove the paper clip and turn the shear valve to the inner (needle) position. Repeat the process to set the opto in this position too. Move the shear valve by hand when aligning opto sensors, remove the paper clip when done. Check the alignment by moving the shear valve in Service testing menu. Note the in needle position, the SVOPTO is fixed with two screws. Loose and tight both screws during alignments. The SVOPTO PCB screws can be accessed by the holes under the blood sensor.

6.3 Amplifier offset setting

Values for of Offset values manual offsetting the channels

Auto-offset

Send settings Field for manual offsetting

The analyzer contains several amplifier circuits to gain signals during the measurements. An ideal amplifier gives zero mV output if input is has 0mV. In reality, the amplifier's output always has some electric potential which is different than zero. This voltage is the offset of

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Servicemanual the amplifier and has to be zeroed to avoid any effects on the measurement results. In Service menu Adjustments screen, it's possible to set these values manually or enable the checkbox to use the auto-offset option. There are three amplifier channels in the optical head, all three should be zeroed to avoid noise during optical measurement. CH0: Channel for Low angle gain CH1: Channel for High angle gain CH0 DC: Channel for optical head DC level. Amplifier offset should be between ±5mV. It's possible to check offset values by pressing Read data button. Reading the offset continuously will turn the start button red, indicating that the internal communication is busy. The system cannot command the Low Level software until the offset reading is Stopped. Impedance amplifier offset can be adjusted separately, also by filling the potentiometer field in the middle or by using Auto-offset checkbox. Always press 'Send settings' button to finish adjustments. Offset setting are done by LSDACQ. If Auto-offset is not working or values are not close to zero, replace the LSDACQ.

6.4 Blood sensor calibration Hemolyzer 5 contains a blood sensor to ensure that the value of the sample is the same during every measurement. After every startup, the system calibrates the blood sensor automatically by making a Wakeup process. During wakeup, the system creates a bubble in the wash head and pulls the bubble inside the blood sensor. The sensor measures the number of steps that the dilutor has to make to pull the bubble into the sensor. The system repeats the process three times and records the number of the steps. During the wakeup, these numbers are displayed in MDA screen if MdaOn checkbox is enabled. Result of blood sensor lib ti MdaOn checkbox has to b bl d

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Hemolyzer 5

Field to enter number of test functions

Checkbox to enable or disable blood sensor

Press MDA to view MDA screen

If the number of steps are the same for two times (out of three), the sensor calibration is successful. If all three values are different, the sensor calibration is failed. Failure of the calibration is displayed as a 'T' flag after a blank, control or human measurement is finished and warning exclamation mark is also shown on the bottom of the display. If blood sensor calibration problem appears, it's possible to run Wakeup process directly from Service functions. See test functions list in section 7.3.1.1. The sensor can have problems sensing the bubble's position because the sampling tube is not transparent enough or it's dirty. In this case the tube between the needle and the shear valve has to be replaced. Note that the calibration value is strongly depends on the state and position of the sample tube. This tube in the blood sensor is not fixed and its position can be changed by pulling the tube during a shear valve adjustment or cleaning. The tube is set correctly if calibration value is in a range 44-49. If the value is different, it can cause sampling problems, 'W' flag or it can happen that the sampling tube will be too tense when the needle is piercing a sample from the Auto-Sampler. Make sure that the tube between the shear valve and the blood sensor is horizontal, not too tense and transparent.

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Servicemanual

6.5 Sample position setting The measurement starts with a blood sample aspiration. The blood sample needs to be moved to a specific location through the shear valve. Open the front cover of the analyzer and observe the beginning of the measurement process. The below adjustment is necessary to allow the sample reach this location – to avoid sampling errors and thus avoid optical measurement errors During sampling, the blood sample must go beyond the last loop of the shear valve, as indicated on the image. The purple area is a schematic representation of the purple area on the shear valve in the Hemolyzer 5. Please locate this tube in the analyzer (the tube is connected to the V41/1 tube in the vertical tube organizer. Run a control blood sample. If the sample position is between 2 and 8 mm, then do not change the default position. If the three loops are not filled with blood or the sample stops more than 8mm beyond the shear valve, the sampling settings has to be set in Adjustments screen.

Length of sample position used if blood sensor is enabled

Default blood position value is used if blood sensor is not enabled

In Adjustments screen, the sample position can be set at Needle tube full length/sample position. If blood sensor is enabled, the system uses the top value (70 by default) to position the sample. This value can be calibrated by pressing Calib length button. •

If button is pressed, the system will create a bubble in the wash head and pulls it through the sample tube and the three loops to the top of the shear valve. The software will ask whether the bubble is visible at the top of the shear valve, this has to be checked visually.

65

Hemolyzer 5 •

If the bubble is not arrived to the correct position, press Cancel to make the system (the dilutor) pulls the bubble higher from the shear valve. The system will ask to check every new position after Cancel is pushed.

•

If the bubble is in position press Ok. The system will overwrite the old sample position value (default 70) with the newly set value.

•

Rerun a control sample. Observe the position. Run calibration again if sample position is not proper or type in a new value by hand. If value is changed by hand, press Set length button to save the new value.

If the blood sensor is disabled or not working properly, the system will use the bottom value so called the default blood position. It is not possible to calibrate this value, but it can be modified by typing in a new value. After the value is modified, press Set default blood position button to make new setting accepted. This value should be in a range 0.190-0.220. Make sure that the format of this entered value is correct and “0.” is visible. It's important to keep this value under 0.22 because larger values will make the blood sample override the shear valve and will enter to the reservoir. Always use blood to test the sample position after the following: •

sample position value was calibrated

•

sample position value was changed (with blood sensor)

•

default blood position value was changed (without blood sensor)

•

blood sensor was turned off or on

•

sample tube was replaced or its position was realigned

•

shear valve was disassembled

•

XY adjustments was realigned (horizontal, vertical, wash head, needle)

•

wash head was cleaned

Always test blood position from Auto-Sampler. Make sure that sample position is proper both from Sample rotor and Auto-Sampler.

6.6 Pressure sensor adjustment Similar to the amplifiers, the pressure sensors also has offsets. It is also possible to zero the pressure sensor's offsets in Adjustments menu by pressing the Start adjustment button. The offset compensating is done automatically, showing the offset results in mBars. These values must be 0 ± 20 mBars. If one value is higher than 20mBars, the pressure board needs to be replaced.

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Servicemanual The sensors can work with higher offsets than 20mBars, but if values are higher than 30mBars the system will give a pressure sensor offset error and if the values are higher than 40mBars it will cause a pneumatic error.

6.7 Set serial number It is also possible to enter the instrument's serial number in Adjustments menu. Simply type in the correct number and press Set serial button. The serial number of the instrument is stored in the Hardware block, the LSDACQ and the DimmBoard. Serial number is also indicated in the label on the back of the instrument. Serial number has to be typed again if: • Dimmboard was changed • Low level software was reinstalled • LSDACQ was changed • HDD was changed • High level software was reinstalled

6.8 WBC preheater In Adjustments screen, it is possible to set the WBC preheater's temperature. The default value is 375 indicating that the temperature should be 37.5 °C. By pressing Read data button, it's possible to check the preheater current temperature. Make sure that the preheater's value is 375 (37.5°C), if it is not possible to set the temperature or values are too high, check WBC preheater's cable or replace LSDACQ board.

6.9 Setting Laser values Every laser head has unique values which have to be set in the instrument for proper working. These values were set by Analyticon, but has to be set again if the laser head was replaced. In Auto Alignment screen it's possible to check or overwrite the values. The Read DC button and the laser values are accessible, but other options are password protected. Password is asked every time when entering Auto alignment menu. Do not change the laser values unless it's necessary.

6.9.1

Calibration procedure of optical heads

1. Enter to Service/auto alignment menu (password:47715481) and set optical head values as shown below:

Laser power: 120 Low angle gain: 130 High angle gain: 210

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Hemolyzer 5

2. In service/service calibration menu, set Scatter X and Scatter Y values to 1,1. Press Accept when done.

These values needs to be set to make a proper start for the laser to calibrate.

3. In settings/system/set menu, select Gravity X and Gravity Y columns on the right list, and put them to the used columns on the left list by pressing the left arrow. Press done and save when ready.

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Servicemanual

4. Do a control measurement using a control blood. In the database find the results of the measurement. Check the Gravity X and Gravity Y values of the measurement and compare them with the Gravity values shown on the blood sheet of the actual control lot.

5. If measured Gravity values (X and Y) are between 0,8 x Lot Gravity values (X and Y) and 1,2 x Lot Gravity values (X and Y)(+-20%), then the Gravity values can be calibrated by software. 6. If measured Gravity X is lower than 80% of Lot Gravity X, raise low angle gain in auto alignment menu to bring the measured Gravity X value closer to Lot Gravity X. If measured Gravity X is higher than 120% of Lot Gravity X, then lower the low angle gain to bring the measured Gravity X value closer to Lot Gravity X.

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Hemolyzer 5

7. If measured Gravity Y is lower than 80% of Lot Gravity Y, raise high angle gain in auto alignment menu to bring the measured Gravity Y value closer to Lot Gravity Y. If measured Gravity Y is higher than 120% of Lot Gravity Y, then lower the high angle gain to bring the measured Gravity Y value closer to Lot Gravity Y. 8. Repeat the process until the measured Gravity values are between 80% and 120% of Lot Gravity values. 9. If values are ok, enter service calibration and check enable scatter calibration.

10. Press ok and browse the AS file for scatter calibration. 11. When ready, go to calibration menu and perform a calibration (min 3 measurements) 12. The new Scatter X and Scatter Y will appear. Press ok. 13. Calibration is done.

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Servicemanual 6.9.2

Short guide for laser values

This is a short description to give information about the values and settings of the optical head assuming that user understand the operation of the optical measurement. Concepts: Gravity X Gravity Y Low angle gain High angle gain DC level

Scattergram Scatter scale X Scatter scale Y WOC4 WOCB Laser Power

Scatter diagram (Scattergram): The scattergram is responsible to view the white blood cell populations. The 4 diff scatter indicates the 4 differential populations (LYM, MONO, NEU, EO), the Baso scatter shows the BASOPHIL population. Both scattergrams are indicated as a square, surrounding all the populations. In default, the scatter has a size 1.00 x 1.00. This scattergram can be magnified, making the cells / populations change positions. The size of the scatter is defined by the scatter X (horizontal) and scatter Y (vertical) values. These values are 1.00 in default and can be modified by calibrating the scatter. The values of Scatter X and Y are shown in service calibration menu or it can also be found on factory settings menu. Gravity values: Gravity values are specific numbers for all type of control blood for instruments with optical measurements. These numbers indicates the center of gravity. All cells (which is part of a population and not noise) are counted and added horizontally, line by line and divided by the number of lines shown in the scatter. This value is the Gravity X value. The Gravity Y is created the same way; all cells attached to a population are added vertically and divided by the number of columns shown in the scatter. All controls have its own gravity values, these values are used as target reference during calibration. The gravity values are stored in an AS file and can be uploaded or added manually before making a calibration.

71

Hemolyzer 5 (After a measurement, the gravity values are indicated in the measurement database.) WOC4 and WOCB values: WOC4 (WBC Optical Count for 4 diff scatter): indicates the ratio of WBC cells included in the 4 diff measurement. Min. value: 2.72 WOCB (WBC Optical Count for Baso scatter): indicates the ratio of WBC cells included in the BASO measurement. Min. value: 5.44 These values are also displayed in the measurement database, showing that the number of cells during measurement is enough. If WOC4 is low (and WOCB is ok), it can indicate that the TCU is clogged and only a little amount of cells entered the flow cell. If WOCB is low (and WOC4 is ok), it can indicate that there is a partial clogging in the WBC chamber, not allowing the cells to reach the flow cell. If both values are low, it means that the flow cell is clogged (both 4diff and Baso cells aren’t sensed by the laser) and needs to be cleaned by software or manually. Neutrophil area center point: If the measurements are displayed with Analyzer Spy software, there is a chance to enlarge the image of the actual measurement’s scatter. There is a small green cross appeared on the scatter (both 4diff and Baso). This marker is created to help the laser’s calibration procedure, if there’s no control blood available for measurement. The marker indicates the Neutrophil populations center point. With the use of this marker, the user can manually set the scatterX and Y values in the Analyzer Spy software. By enlarging the scatter with X and Y scale scatter values, the Neu population field can shifted to a position where the marker is the middle of the Neutrophil population. This is a harsh approximate calibration showing the proper Scatter values. This values can be set in the instrument manually in service calibration menu or factory settings. Laser Power and gains: In auto alignment menu, there is a chance to set the optical head values, laser power, low and high angle gains. These values are set by Analyticon QC, but these values can be modified to align the optical head operation to the instrument. Every optical head has an unique setting of values. These values can be set in auto alignment menu and stored in the instrument’s memory. The values are not stored inside the laser. If optical head is changed in the instrument, the new laser’s values have to be set in auto alignment menu to make the new laser’s operation proper. Also note that these values are reset to default, if the windows is reinstalled or a hardware block is changed.

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Servicemanual Laser power values (both for 4diff and Baso) indicate the current operating the Laser Diode. The higher the laser power value, the lower the current flows though the diode. If the power values are increased, the current will be decreased making the scatter smaller in both dimensions (X and Y). Laser power value had a range from 54 to 96. Older (2012 and older) type of laser’s must keep this range (54-96) with a standard low angle gain 48, and high angle gain 112. In new type of optical heads (created in 2013 and after), the optics, flow cell size and amplifier is modified. This modifications increases the ranges both for power and gains. See ranges for new type of optical heads below:

Laser power:

70 – 130

Low angle gain:

0 – 255

High angle gain:

0 – 255

Note that the lower the laser power value, the higher the Laser diode’s current, which can create NOISE during laser blank measurements. These NOISE is indicated by warning flags n, N at the end of a measurement. The diode’s light is sensed by the detector. The area of detection is masked by a metal plate to ignore the LED’s direct light hitting the sensing zone. The zone is separated to two different subzones. The internal zone responsible to sense the low angle signals (size of cells), the outer larger zone is for sensing the high angle signals (internal structure of cells). Both incoming signals are very weak and must be gained by an amplifier. The Low and High angle gains are the gain values of the laser’s amplifier, these values also can be set in auto alignment menu. In older optical heads, this values are standard 48 and 112, but new optical head’s -with 3 stripes on the side- has a range of gain values. The gain values are good to make small scatter alignments to improve the Gravity values and Scatter sizes in small amount. Note that the values are directly proportional, the higher the value the higher the gain is.

DC level: The DC level value indicates the amount of light hitting the LOW ANGLE SENSING ZONE without any cells involved. This value has a minimum and maximum range. Low DC level could mean that the beam of light is misaligned, high DC level means dirty flow cell or optics.

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Hemolyzer 5

7 Verification procedures 7.1 Self-test The analyzer has built in test function to check and evaluate operation of internal modules and systems. The function is accessible from the Main Menu, Diagnostics, Self-test function. There are two subsets of tests: electronic and pneumatic. Each process takes approximately 1 minute, and provides results of each tested parameter. You can select to run both test sets, by clicking on the “Start Both” button. Accepted ranges are displayed below.

Big buffer time

Small buffer time

Generate Release

Generate1 Generate2 Release

3000 - 13000sec 3000 - 6000sec

1200 - 2800sec 1200 - 2800sec 700 - 1300sec

Big buffer drift

Small buffer drift

Maximum Minimum Drift

Maximum Minimum Drift

540 - 560mBar 530 - 560mBar -5 - 15mBar

Pump status Pump1 Pump2

Null pressures 1-1 1-1

TCU Reference Actual Sink

-20 - 20mBar -20 - 20mBar -20 - 20mBar

Laser off Laser on

0 - 0.05V 0.06 - 0.8V

Battery 0 - 3000 pulses 3000 - 60000 pulses

Electrode Voltage Current Offset

Sheath Capillary Chamber

Laser temperature/Optical 25 - 38°C Reference +- 0.2 °C 0 - 70°C

HGB LED HGB Dark HGB light

225 - 235mBar 215 - 235mBar -5 - 15mBar

Battery voltage 2.7 - 3.3V +12V 11.4 - 12.6V -12V -12.6 - -11.4V

Noise/Pulse 45 - 55V 620 – 680μA -5.0 – 5.0mV

pls/5sec 20000pls

0 - 2000 pulses 19990 - 20050 pulses

Would any value fall outside the above defined range, the SW will indicate it with a red, “Failed” string. Correct and acceptable results are indicated with a “Passed” string.

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Servicemanual

7.1.1

Hemolyzer 5 Self-Test Guide

The Hemolyzer 5 Self-Test provides information about the actual status of hardware and software of the analyzer. This guide is intended for helping service engineers to correctly interpret Self-test result and to provide guidelines in troubleshooting the instrument. It is possible to perform electronic Self-Test only, pneumatic Self-Test cannot be performed separately.

7.1.1.1 General information High level SW version: ……. Low Level SW version: ……. • Low and high level SW version must be identical. For proper functioning of the instrument the two software versions has to be the same.

LSDACQ Firmware; LSDACQ PIC; Optical head; TCU SW versions; LSDACQ version: •

All these must have version numbers. If version number isn’t displayed that can indicate failure of part or communication error.

•

LSDACQ version number provide information about compatibility with certain electronic components;

OPT sensor board; TCU board; Pressure board; Laser driver board: •

These are intelligent components which communicate with the low level software via I2C bus. All boards must be „PRESENT” for correct operation of the analyzer.

•

If any of these components is reported „NOT PRESENT” that indicate failure of part, cable or connection problem.

Corrective action: Check cables and LSDACQ status LEDs

7.1.1.2 Electronic Self-Test parameters TCU temperature(C°):

•

Actual: normal operating temperature of TCU unit is 29+/- 0,2 C°. Lower/higher temperature indicate failure of heater/cooler circuit.

Troubleshoot accordingly. •

Heatsink: cooling of TCU is done by Peltier elements. Heat generated on the other side of the elements is dissipated by a heatsink and cooling fan. Failure of fan leads to overheating and damage of Peltier elements.

Corrective action: check and/or replace TCU

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Hemolyzer 5 •

Laser DC level: Laser DC (Dark Current) is the reference value of the optical measurement circuit. Measurement is performed on diluent. When the optical flow cell is clean and bubble-free, laser light isn’t scattered by anything and only a very small signal should be measured by the detectors.

•

Laser off: DC level recorded without laser light. If out of range, probably the Optosensor card is defective. In such case usually the Laser on value is out of range too.

Corrective action: Check laser head's cables, change Laser Head Assembly •

Laser on: DC level with laser light. If Laser off value is in range but Laser on value is high, it can indicate: dirty flow cell, bubbles in the flow cell, misaligned laser.

Corrective action: -

run „Flow Cell Cleaning” followed by blank measurement to wash out any air bubble from the flow cell and repeat Self-test. If DC level is OK => nothing else to do

-

manually clean* the flow cell with bleach solution

-

wipe the flow cell sides with lint-free lens paper dampened with isoprophyl-alcohol

-

change Laser Head Assembly

Laser head must be opened for this operation! Power off the analyzer, and proceed with precaution; take extra care not to damage or misadjust any internal component of Laser Head. Electrode: These are the main parameters of impedance amplifier board. •

Voltage; Current: is out of range, the amplifier board or the high voltage board might be defective

Corrective action: check or replace HVB board, check or replace amplifier board, check cables •

Offset: if voltage and current is in range, offset can be adjusted. If the offset cannot be adjusted or it is unstable, check or replace the amplifier board and /or LSDACQ.

Corrective action: change the impedance amplifier board or LSDACQ •

Battery / Power supply: Monitors the supply voltage of LSDACQ board (+/- 12V) and the real-time clock battery voltage.

Troubleshoot accordingly Laser parameters: •

Temperature(C°): temperature of laser diode block, for information purposes only

•

Laser Power: the value of laser power setting. It is not percentage (!), just a digital number.

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Servicemanual DO NOT CHANGE THIS VALUE UNLESS IT'S NECESSARY OR YOU INSTALL A NEW LASER HEAD IN THE ANALYZER. IN THAT CASE LASER POWER VALUE TO BE SET IS WRITTEN ON THE AUTOALIGNMENT SHEET OF NEW LASER HEAD OR ON THE SIDE OF THE OPTICAL HEAD. •

HGB Head (electronic): HGB diode and sensor test.

•

HGB dark: measured without light, if out of range probably the sensor is defective or too much external light reached the sensor

•

HGB light: measured with HGB diode on, if out of range that can indicate diode or sensor failure

Corrective action: check chamber and amplifier for salt buildups, replace HGB head •

WBC Preheater: if out of range it can be adjusted in „Service/Adjustments”

•

LSDACQ: show the temperature of the Dimmboard

7.1.1.3 Pneumatic Self-Test parameters •

Big buffer time(msec): The time necessary to generate the required vacuum in the big(sheath) buffer.

•

Generate(P1+P2): failed indicate weak pump, leak in vacuum system, bad valve head or valve coil, kinked tubing, etc.

•

Release: time necessary to completely vent the buffer, if failed, valve #5, related tubing and vent nozzle can be at the origin of failure

•

Small buffer time(msec): The time necessary to generate the required vacuum in the small(capillary) buffer.

•

Generate: failed indicate weak pump, leak in vacuum system, bad or valve head or valve coil, kinked tubing, etc.

•

Release: time necessary to completely vent the buffer, if failed, valve #5, related tubing and vent nozzle can be at the origin of failure

•

Big buffer drift(mBar): Failed indicate leakage in the sheath buffer-related vacuum system. Troubleshoot accordingly.

•

Small buffer drift(mBar): Failed indicate leakage in the capillary buffer-related vacuum system. Troubleshoot accordingly.

•

Max vacuum P1(mBar/sec): The maximum value of vacuum that can be generated by the pump in a given range of time. Failed indicate weak pump or problem in related valves or tubing.

•

Max vacuum P2(mBar/sec): The maximum value of vacuum that can be generated by the pump in a given range of time. Failed indicate weak pump or problem in related valves or tubing.

•

Pump status: Failed indicate that the pump wasn’t sensed by the electronic system. Possible pump, connection, cable or PPB board failure

•

Pressures – buffers vented(mBar): Show the remaining pressure/vacuum in the buffers, after the instrument released the vacuum. If (any)failed, check related tubing,

77

Hemolyzer 5 valves, and pressure sensor board, run pressure offset adjustment and repeat Selftest. •

Noise/Pulse: This is an electronic test but it require diluent to be present in the counting chambers.

•

pls/8 sec: if failed either electronic noise is picked up by the electrode or the amplifier board is noisy. Troubleshoot accordingly

•

20000 pls: a test circuit generate 20000 pulses and the counter number them. Failed indicate defective amplifier board

•

HGB head: Same test as in the electronic section, but with diluent in the counting chamber.

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Servicemanual

7.2 Error Messages The analyzer checks the operations of several mechanic, fluidic and electronic parts during measurement. The system shows the type of the error on the LCD display if any kind of malfunction is detected. When an error message pops up, the details contains the processes were involved when the error appeared. The error codes also help to identify the problem. Error code 0 1 2 3 4 5 6 7 8 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36

Description EG_NO_ERROR EG_BAD_VALVE_NUMBER EG_BAD_PUMP_NUMBER EG_PNEU_INIT EG_BAD_CHAMBER_NUMBER EG_ALL_VALVES_OFF EG_NO_ANSWER EG_CANCEL EG_ABORT EG_UNKNOWN EG_ERROR_HANDLER EG_NO_CONNECTION EG_PRIME EG_TEST_FUNCTION EG_MEASURE_PUFFER EG_MEASURE_PUFFER_SPEC EG_CALIB_SENSORS EG_TEST_MOTORS EG_TEST_VALVES EG_TEST_PUMPS EG_PREP_FOR_SHIP EG_CLEAN EG_WASHHEAD_WASH EG_BLANK EG_STRESS EG_EMPTYCHAMBER EG_SHUTDOWN EG_HARDWARE_INIT EG_PNEUCONTROL EG_PNEUCONTROL_VAR EG_PNEUCONTROL_THR EG_PNEUCONTROL_INIT EG_MEASURECONTROL EG_SV EG_SEND_EVENT EG_NEXT_MIX

79

Hemolyzer 5 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 61 62 63 64 65 66 67 68 69 70 71 72 73 74 75 76 77 78 79 80 81

EG_NEXT_PIERCE EG_INIT_PORT EG_INIT_FPGA EG_INIT_PIC EG_INIT_MDATA EG_LOOP EG_SAMPLER_DELEG EG_MOVING_DELEG EG_NMOVING_DELEG EG_COMM_PARAM EG_TEST_DISLPAY EG_INIT_STATE EG_FILE_NOT_FOUND EG_FILE_NO_INFORMATION EG_FILE_OPEN EG_GET_FILE EG_SEND_FILE EG_CRC_CREATE EG_UPGRADE EG_TEST_SPEC EG_ANSWER EG_COMMUNICATION EG_DRAIN EG_NEEDLESETTINGS EG_HARDCLEANING EG_MAININIT EG_WAITFORCONTROLEVENT EG_S_MSGMLR_TIMEOUT EG_NM_MSGMLR_TIMEOUT EG_M_MSGMLR_TIMEOUT EG_PRESSURE EG_THREADS EG_WAITFOREVENT EG_SENDEVENT EG_DELETE_FILE EG_SETTINGS EG_REAGENTS EG_SAMPLER_CONSTRUCTOR EG_SAMPLER_INIT EG_SAMPLER_STOP EG_SAMPLER_GETSTATE EG_SAMPLER_SETSTATE EG_SAMPLER_GETPOSITION EG_SAMPLER_SETPOSITION EG_SAMPLER_GETCONTAINERTYPE

80

Servicemanual 82 83 84 85 86 87 88 89 90 91 92 93 94 95 96 97 98 99 100 101 102 103 104 105 106 107 108 109 110 111 112 113 114 115 116 117 118 119 120 121 122 123 124 125 126

EG_SAMPLER_CANCEL_WAITSTATE EG_SAMPLER_WAITSTATE EG_SAMPLER_ONLINE EG_SAMPLER_SAMPLERDY EG_SAMPLER_ERROR EG_SAMPLER_FATALERROR EG_SAMPLER_SENDPOS EG_SAMPLER_BARCODE EG_SAMPLER_INITDONE EG_SAMPLER_STOPPED EG_SAMPLER_TRAYDONE EG_SAMPLER_PONG EG_SAMPLER_SAMPLEMIX EG_SAMPLER_BAROK EG_SAMPLER_SENDTRAYINFO EG_SAMPLER_SENDRACKINFO EG_SAMPLER_UNKNOWNCMD EG_SAMPLER_CMD EG_SAMPLER_TRAY_DONE EG_SAMPLER_STARTPOS EG_AUTOSAMPLER_MEASURE EG_FILL EG_TEST_PIERCE EG_MOVE_DILUTOR_1 EG_MOVE_DILUTOR_2 EG_MOVE_DILUTOR_3 EG_MOVE_DILUTOR_4 EG_BOB EG_HORIZONTAL EG_VERTICAL EG_DILUFULL EG_GET_BUBBLE EG_BUBBLING EG_MICRO EG_MEAPUFF EG_MEAPUFFBIG EG_MEAPUFFSMALL EG_PREDIL EG_DIL_L EG_SAMPLE_MOVE EG_NEEDLE_WASHING EG_WBC_STOP EG_MIX_SAMPLE EG_CHAMBER_MIX EG_CHAMBER_RBC

81

Hemolyzer 5 127 128 129 130 131 132 133 134 135 136 137 138 139 140 141 142 143 144 145 146 147 148 149 150 151 152 153 154 155 156 157 158 159 160 161 162 163 164 165 166 167 168 169 170 171

EG_CHAMBER_WBC EG_HGB_MEASURE EG_BASO_MEASURE EG_BASO_SAMPLE EG_RBC_MEASURE EG_WASHING_DIFF EG_PREDRAIN EG_SENDTHEEND EG_WBC_MEASURE EG_OPT_SAMP_CL EG_SET_POSITION EG_BURNRBC EG_BURNWBC EG_TIMEOUT EG_TOTTI EG_AAMVERT EG_AAMHORI EG_AUTO_ALIGNEMENT EG_STOP_PUFFER EG_LYSE_PUFFER EG_DILUENT_PUFFER EG_SHEATH_PUFFER EG_PRIME_DILU EG_PRIME_SHEATH EG_PRIME_LYSE EG_PRIME_STOPPER EG_AS_ERROR EG_RINSE EG_PNEU_INIT_2 EG_DELAY EG_WAKEUP EG_STANDBY EG_CHECKPRIME EG_SELFTEST EG_LASERHEAT EG_LASERHEAT_INFO EG_MACHINEINFO EG_FILELIST EG_SV_CLEAN EG_AUTOSAMPLER EG_EXTRA1 EG_EXTRA2 EG_EXTRA3 EG_UDILUTOR EG_CHAMBERS

82

Servicemanual 172 173 174 175 176 177 178 179 180 181 182 183 184 185 186 187 188 189 190 191 192 193 194 195 196 197 198 199 200 201 202 203 204 205 206 207 208 209 210 211 212 213

EG_CELL_CLOGGING EG_FILL_LASER EG_DEBUG EG_REPAIR EG_CANCEL_ANSWER EG_CANCEL_AT_END EG_PIC_ERROR EG_SET_OFFSET EG_AS_INFO EG_REAGENT_LOCK EG_RV_RD_ERROR EG_RV_WR_FAULT_ERROR EG_RV_WR_PROTECT_ERROR EG_RV_ARG_ERROR EG_RV_UNEXPECTED_ERROR EG_RV_KEY_ERROR EG_RV_CRC_ERROR EG_RV_PERMISSION_ERROR EG_RV_DEVICE_MISSING_ERROR EG_RV_NOT_ENOUGH_MEASUREMENTS EG_SERIALS EG_OFFLINERINSING EG_DC EG_CLEANCELL EG_CLEANDILU EG_QCWIZARD EG_QCTEST EG_CHECK_ALTITUDE EG_RELEASE_AIR EG_AS_COVER EG_BLOODSENSOR EG_BLOODSENSOR_CALIB EG_OVERNIGHT_CLEAN EG_PRESSURE_OFFSET EG_CANCEL_REPAIR EG_DRAIN_TCU EG_FILL_TCU EG_DRAIN_FLOW_CELL EG_FILL_FLOW_CELL EG_XY EG_EMPTYRCHAMBER EG_EMPTYWCHAMBER

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Hemolyzer 5

7.3 Service Menu There is a Service menu for servicing and operation checking purposes; however it is hidden from the standard user. To access the service menu: With on screen keyboard active: •

Go to the Main Menu

•

Tap and hold the Main Menu icon for appr. 6 seconds

•

Accompanied by a “bing” sound, the password entry dialog will be displayed.

•

Enter the service code (6484A5)

•

The service menu icon will be displayed

With onscreen keyboard inactive •

Connect an external USB keyboard

•

Go to the Main Menu

•

Make sure the arrow is over the Main Menu icon

•

On the external keyboard, type 6484A5

•

Press enter

•

The service menu icon will be displayed

Enter the following code to access service menu: 6484A5 Password is case sensitive

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Servicemanual Once you typed in the correct service code, you will enter into the service menu. The system is designed to provide you continuous access to service functions: you will have to enter the service code once for a specific service session. The button in the lower right corner says “Service mode OFF”. This is the EXIT point of the service menu. Do not forget to end service operation by tapping the “Service mode off” button to prevent users accessing the service menu. The following screen displays available operations and functions. Refer to the menu screen above to locate the description of the feature.

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Hemolyzer 5 7.3.1

Service functions

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Servicemanual 7.3.1.1 Test functions This item allows running specific test procedures. You have to enter the “ID” of the required service and RUN the process. The list of available functions and their expected result is listed below. ID 2

Name Go to Standby

3

Drain tubing system

4 15 61 62 63

Wakeup Skip clean Skip (next) Pneuinit Skip (next) Rinse Make PneuInit Mandatory Make Pneuinit and Prime Mandatory Make Fill Mandatory

64 65 66 67 68

Skip Pneuinit, Clean and Wakeup Skip Pneuinit, Wakeup Skip Pneuinit, Rinse and Wakeup

Expected result The system will go into standby independently of standby timer status It is equivalent to tapping the “Drain all” function under Main Menu / Maintenance / Drain all The system performs wakeup function. The system will assume Cleaning has been performed The system will omit pneuinit The system will omit Rinse (tube washing process) The system will be forced to do a pneuinit (as if it was just powered on) All motors and the tube system is set to uninitialized state. (equivalent to power off) Equivalent to first startup – the system will assume that all pneumatical systems are empty. Combination of various functions Combination of various functions Combination of various functions

7.3.1.2 Low level file management Allows accessing files located in the DimmBoard’s SD card.

7.3.1.3 Low level reboot (DimmBoard) This command allows restarting the Low Level software which controls the pneumatic system. This might be necessary when the communication is lost between the High and the Low level systems. Typically: when the Start button remains RED without pneumatically action and the system does not respond to user commands. This function forces the DimmBoard controlled system into a known basic state.

7.3.1.4 Pneumatical System – Initialize When Initialize starts, the system moves all mechanical components to their "standby" position. This function allows starting up pneumatics after mechanical alignments or a system startup. The system will perform an Init process after Wash head and Needle alignment or when Service testing menu was used.

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Hemolyzer 5 7.3.1.5 Network management This is the input area to define network related parameters in connection with LIS communication. The parameters required for setting up the link should be acquired from the system operator of the network you want to connect the analyzer to.

7.3.1.6 RAW data saving mode Allows selection of RAW (unprocessed) data file save mode. Raw data files can be important for Analyticon support or R&D team to analyze and troubleshoot. Turn on Raw data saving mode to make the system save measurement data during further measurements.

7.3.1.7 Export RAW files Allows saving collected RAW data files to a removable storage media, typically USB Flash memory.

7.3.1.8 Windows Control Status This setting controls whether the CTRL-ALT-DEL combination can be used to access system functions or not. This setting is suggested to be turned OFF after installation of the analyzer at the end user’s site to prevent unauthorized access to system files. This setting requires a system reboot.

7.3.1.9 TCU fill/drain Allows to fill the TCU tubing system with reagents or remove all liquid from the tubing. Recommended to use draining before and fill after TCU removing.

7.3.1.10

Flow cell fill/drain

Fills up or completely removes all liquid from the optical head. Use drain before removing laser head.

7.3.1.11

Blood sensor status

Turns on and off the blood sensor

7.3.1.12

Reset statistics

This function resets the statistic screen. The statistic contains information about the instrument's history. It shows the number of startups, shutdowns, errors, etc. See section 16.4 in User Manual.

7.3.1.13

Hard drive maintenance

Makes a defragmentation on the hard disc. It can be used to make the system faster is database contains too many measurements.

7.3.1.14

Show advanced DB view

Changes the database screen to contain more information

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Servicemanual 7.3.1.15

Small sample mode

Enables to use small sample mode if it's installed into the system.

7.3.1.16

Pre-diluted mode

Enables to use pre-diluted blood sample.

7.3.1.17

Monitoring

Allows to connect the system to an external computer by entering its IP address. If monitoring is enabled, it's possible to see how the unit is used in real time on a PC or laptop which is located in another area.

7.3.2

Service testing

Service Testing menu provides tools for checking hardware. •

Valves - In the menu you can see buttons (each represents a valve). The state of buttons is similar to the state of valves.

•

Motors - In the menu you can see buttons (each represents a command to motor). By pressing a button you can send the motor to the requested endposition.

•

Pumps - In the menu you can see buttons (each represents a pump).By pressing the buttons you can turn on and off the pumps.

•

Also allows to monitor pressures in real time on all three pressure sensors.

89

Hemolyzer 5 7.3.3

Service calibration

The analyzer provides a menu for Service calibration purposes. This screen displays the actual calibration factors, service level calibration factors and the user level calibration factors. Service and User level factors are multiplied and the system is using the result as the actual calibration factor for each measured value. Example for RBC: RBCDisp. = FactRBC User * FactRBC Serv * RBCMeasured Service calibration screen displays both factors for the values measured in the chambers and in the optical head.

7.3.3.1 Enable scatter calibration This checkbox has to be enabled to make a scatter calibration. The system will ask for the scatter calibration file (AS file) which contains the gravity values of the selected control blood. After the AS file is selected, push calibration to measure with control blood. After measurements are done, the system will display the new scatter values.

7.3.3.2 Backup Calibration It is possible to save the calibration factors to a ‘bak’ file. This option is recommended before reinstalling the operation system or the High Level software. Save the calibration file to a pendrive.

7.3.3.3 Restore Calibration It is possible to restore the saved calibration values from a pen drive by pushing Restore Calibration.

7.3.3.4 Load Calibration The system is capable to upload calibration factors made by the Analyzer Spy software. This is useful when Backup calibration option was missed before software reinstall and all the factors are reseted to 1.00. The Analyzer Spy software can create a fact file with all the defined calibration factors. Load the fact file with Load Calibration and not with Restore Calibration.

90

Servicemanual 7.3.3.5 Accept User factors Pushing this button will reset the User factor values to 1.00. Reset values will be multiplied with Service factors, creating new Service factors.

7.3.3.6 Back Returns to Service menu screen.

7.3.3.7 Accept Actual calibration factors can be modified by tapping the touch screen. After new values are typed in, Accept has to be pushed to make the system use the new factors.

7.3.4

Stress measure

In Stress mode, the instrument performs measuring cycles without sample (blank measurements) continuously. This can be used for burn-in tests, or to check pneumatic system after changing any main fluidic parts. You can have information about stability, cleanliness, HGB operation, and counting time stability. It is possible to Load last stress results to gather more information of the analyzer.

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Hemolyzer 5 7.3.5

Auto alignment

This function allows access to adjusting the optical head’s laser alignment. The page is password protected, but some functions are accessible without entering the password. •

Laser settings can be typed in manually. After values are entered, press Save values to confirm the settings.

•

By pressing Read DC, it is possible to check the status of the optical head. DC level is also indicated in Self-test menu. If DC level is in range it means that the flow cell and the laser diode is proper. If the DC is high or not steady, flow cell cleaning needs to be done.

Always type in the new Laser settings if optical head was replaced.

7.3.6

AS (Auto-sampler)

This function allows accessing and testing various functions of the Auto Sampler.

7.3.6.1 Go to Pos Pulls the selected rack position -defined by the RackPos and SamplePos-in front of the mixer.

7.3.6.2 Reset Sets the Auto-Sampler to default position

7.3.6.3 Repeat last command Repeats the previous action.

7.3.6.4 Go To Mixer Pulls the selected rack position -defined by the RackPos and SamplePos-into the mixer.

7.3.6.5 Load to sampling position Pulls the selected rack position -defined by the RackPos and SamplePos-to the needle

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Servicemanual 7.3.6.6 Set up Barcode Reader

7.3.7

Adjustments

This page contains software and mechanical adjustments. These adjustments and values have to be set correctly for proper working. •

Optical channels offset

Reduces the offset voltages in the optical head. Can be set by hand or automatically. •

Impedance amplifier offset

Reduces the offset voltages in the amplifier board. Can be set by hand or automatically. •

Needle tube full length/sample position

Sets the correct blood position by default or by using Blood sensor. •

Pressure offset adjustment

Sets the pressure sensors to reduce the sensed pressure offsets during measurements. •

Needle & wash head adjustments

Sets the mechanical parts to position for checking and adjusting. •

Also possible to retype the system's serial number after a hardware (DimmBoard, LSDACQ, Hardware block, HDD) change.

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Hemolyzer 5 7.3.8

Multiuser Settings

In this page the Administrator can create new user profiles or delete existing users. More than one user can have access to the analyzer if Multiuser mode enabled checkbox is set. The user will have Administrator rights if the Administrator checkbox is enabled.

7.3.9

MDA view

This screen allows monitoring activity of the Low Level software in the DimmBoard. Regularly, communication and pneumatic procedures post status report on this screen. Analyticon Support may ask you to open this window and report messages. MdaOn checkbox has to be enabled to see the activity of the Low Level software.

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Servicemanual 7.3.10 Software upgrade The software of the Instrument can be upgraded using a commercially available USB flash memory device. Hemolyzer 5 software can be upgraded with software releases from Analyticon. It is recommended to install both upper (Windows XP) and lower (DimmBoard) software from the same release package to keep maximum performance and compatibility. However software releases come in packages, it is possible to install the upper and lower software independently.

7.3.10.1

Refresh data

Shows the serial number and all software and firmware versions installed on the analyzer.

7.3.10.2

Change High Level software

Brings up the screen where the High Level software file (msi file) can be selected (browsed). Make sure that the file is prepared on a pen drive attached to the instrument.

7.3.10.3

Change Low level software

Brings up the screen where the Low Level software file (lls file) can be selected (browsed). Make sure that the file is prepared on a pen drive attached to the instrument.

7.3.10.4

Change Low level boot

This button needs to be used when the system's software has to be updated from 1.3.xxx to 1.4.xxx

7.3.10.5

Change LSDACQ firmware

Brings up the screen where the LSDACQ firmware file can be selected (browsed). Make sure that the file is prepared on a pen drive attached to the instrument.

7.3.10.6

Change Optical Head Firmware

The optical head's (laser) firmware can be updated here.

7.3.10.7

Change TCU software

The TCU board also contains software which can be updated here.

7.3.10.8

Change AutoSampler software

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Hemolyzer 5 The Auto-Sampler has software similar to the Low Level software in the DimmBoard. This software can be controlled by the High Level software. It is possible to update the software here is new software is enable.

7.3.11 Reagent Lock The analyzer can keep track of measurements and will change (decrease) the number of available measurements accordingly. Definitely, some service actions require measurements with reagents from the User’s licensed tests. The analyzer will thus decrease the license counter. To make up for these measurements, the service engineer can use the dedicated Service Reagent Key to “give back” the used number of measurements to the client. Upon connection of the Service Reagent Key, the numbers of available measurements on the key are displayed. You can enter the number of tests you need to provide for the end user to compensate them for the sample runs related to the service operation. Enter the number of measurements to grant, and click on the Grant button. The selected number of tests will be added to the counter of the analyzer, and at the same time the number of available measurements on the Service Reagent key will be decreased with the granted number. Make sure that the reagent key is connected properly to the instrument.

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Servicemanual 7.3.12

QC Wizard

It's possible to run several automatic tests on the analyzer. QC Wizard is used by Analyticon production to ensure that all mechanical, pneumatic and electrical settings are correct. QC wizard requires a 'lim' file containing ranges for all the tests.

7.3.13 Printer installation Hemolyzer 5 supports all Windows XP compatible printers. To install a printer or a printer driver, you are going to need either an external USB CD or DVD drive for the original printer driver CD, or a USB flash drive with the printer driver. This option allows installing a printer on Hemolyzer 5. Normally, users are not allowed to connect and install printers, since all peripherals must be installed, connected by the representative of the service provider of the analyzer. The add printer button initiates the Add printer Wizard from Windows. Follow instructions on the screen to install the printer.

7.3.14 Factory Settings Accessible to the Manufacturer only.

7.3.15 Service mode OFF Clicking on this button will turn service mode off, and puts you back to the User Menu. To reenter Service menu, you need to type in the service code again. Make sure you finish any service related actions requiring service menu access with clicking on this button to keep the end user away from these functions.

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Hemolyzer 5

7.4 Software systems Hemolyzer 5 has a complex software system. This system can be divided into two parts, low level system and high level system. The low level system (DimmBoard SW) is responsible for the moving parts of the analyzer and the high level system is responsible for the user interactions. The high level system is running on a built-in industrial PC with an operating system (Microsoft Windows XP Embedded).

7.5 General SW installation guide •

Please contact our support team under [email protected] to get the following files: Hemolyzer5.msi Upgrade.lls

• •

Copy all files to a USB memory stick. Power on the Analyzer – do not perform pneumatic operations (like measurement). Connect the USB memory stick to the Analyzer. Wait a few seconds until the LED in the memory stick starts flashing. Go to Service Menu (enter the code: 6484A5) Go to SW upgrade. Press “Refresh data” to see SW versions of individual components. Write down SW versions to a paper (or tap Print icon to print the image). Upgrade software in the following order:

•

• •

• •

Low level SW – tap the “Change Low Level SW”. Locate the lls file on the “E:” drive. (By default, the USB stick should be the E: drive. If not, please browse to the USB stick (F:, …) • •

Select the file by tapping the checkbox next to the file, then clicking OK. The process will start – you can see the progress on the progress bar. High Level SW- Click on “Change High Level SW” – the analyzer will ask you to locate the Hemolyzer5.msi file on the USB stick. Select the file by tapping the

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• •

checkbox next to the file, then clicking OK. The process will start. Click “next, next…install”. Wait for the process to end. Click on “Finish” (the new SW will start).

Note: Software restart (especially if there are more than 1000 samples present in the database) might take several minutes. During this process, the screen will be blank (black – with the mouse pointer displayed). Do not interrupt the process by turning the analyzer off.

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Hemolyzer 5 7.5.1

Install operating system Windows 2.0 install using pendrive

Tools needed: -

Pendrive (at least 4 GB) Pendrive with high level software Windows iso image file 2.0 (winpe_x86_v2.0) Rufus v1.2.0(or higher) application Additional files directory External usb keyboard and mouse

Step 1. To install windows from pendrive, a bootable pendrive has to be created first. Copy the additional files directory and the software rufus_v1.2.0. to your hard disk. Make sure that the windows 2.0 iso file (winpe_x86_v2.0) is also downloaded to the PC’s hard disk. Step 2. Insert the pen drive (4 GB or higher) into the PC Step 3. Run the rufus exe. „Rufus” will automatically find the external device attached to the PC. Select NTFS for File system. Cluster size is default. Make sure that the „Quick format”, the „Create a bootable disk using ISO image” and the „Create extended label and icon files” checkboxes are checked/marked. Click on the disk button to select the windows ISO file. Browse and find winpe_x86_v2.0.iso file. You can also set the „New volume label” to a name of your choice. If setting is ready, press Start button.

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Servicemanual Step 4. Let „Rufus” copy the ISO to the pendrive. It will take approximately 80-120 minutes, depending on the hardware. Do not remove the pendrive during the copy!

Step 5. When copying if finished, you have to select the files in the Additional files directory and copy it to the root of the pendrive. The pendrive is now a bootable windows installer. The Pendrive should look like in the image on the left.

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Hemolyzer 5 Step 6. Now we have to set the hematology analyzer to recognize to Pendrive. Insert the pendrive to the hematology analyzer, also attach the USB keyboard and turn the analyzer on. While the booting process is going, press „del” button to enter to BIOS. In Advanced BIOS Features, set the first boot device to Hard disk.

On the same screen you have to enter to Hard Disk Boot Priority. Select the Pendrive to be first, so the system will use the Pendrive as an external Hard Disk (use + and – buttons to change the order of HDD).

If setting is ready, press F10 and save to exit from BIOS and restart.

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Servicemanual Step 7. available. In this case, remove the bootable pendrive and type in the below commands into the console to create proper partition on the HDD. DISKPART SELECT DISK 0 CLEAN CREATE PARTITION PRIMARY SIZE=100000 FORMAT FS=NTFS QUICK ACTIVE ASSIGN LETTER = C CREATE PARTITION PRIMARY FORMAT FS=NTFS QUICK ASSIGN LETTER = D EXIT EXIT

Replace the pendrive then wait until console window returns. If „e” drive exists type in „installpen” to start the windows install. The system will offer to options, first one is to recover the windows the second one is a full format. The recover format will keep the database, the full format will erase all data from the HDD (which is not a problem if the HDD is new). Choose number 1 or 2 then press enter to start the process. The windows install/recovery would take approximately 30 minutes. If the install is done, remove the pendrive and type „exit” to restart the system. If you didn’t remove the pendrive, don’t press any key when it’s offered, let the system start windows from HDD. If the touch screen is not calibrated, you have to use a mouse to find touch screen calibration on the desktop. Start touchcalib and calibrate the screen, by pushing the 4 corners (crosses) on the touchscreen. If touch is calibrated, insert the second pendrive with the high level software installer, start total commander and run the high level software’s msi file.

The system now restarts and a message will appear on the screen „Press any key to boot from USB”. Press any key, than wait until windows command console window appears. If you miss pressing any key, the system will stop with an error. In this case, restart the system with CTRL+ALT+DEL. As the windows console window appears and it’s ready to receive the commands, type in „e:”. Warning: In case of a new HDD, it can happen that the „e” drive is not

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Hemolyzer 5

Step 8. After install is done, the high level software has to be set properly. Please adjust or set: -

Calibration factors (load or restore calibration factors if it’s saved before)

-

Laser setting (power, low and high angle gains have to be set again for proper scatter values)

-

Offsets on amplifiers (optical measurement and impedance measurement offsets have to be set (zeroed) in adjustments menu)

-

Pressure sensor offsetting (also have to be set to make the pressure sensor work properly)

-

Set the serial number of the instrument (the serial number is also stored on the HDD, after windows install the serial have to be set again. Use adjustments menu to enter the same serial number as on the DIMMPC/DIMMBOARD or on the sticker on the back of the instrument).

Windows and high level software install is done.

7.5.2

Installing a Printer

Hemolyzer 5 is using a Windows operating system. To add a new printer on Hemolyzer 5 you have to install the printer specific driver. The operating system has limited possibilities for user interaction affecting operating system functions. Follow the steps below to install a printer, or use one of the printer install functions from the service menu (see section 7.3.13). 1. Prepare the printer driver on a USB stick. (Either copy it from the install CD, or download it from the printer manufacturer’s web site) 2. Connect a USB external keyboard. 3. Connect the USB stick with the printer driver to an available USB slot on the analyzer. 4. Make sure that Windows control function is Enabled in Service functions menu (section 7.3.1.8). 5. Press CTRL-ALT-DEL on external keyboard to access „Task manager” 6. Select „start new process” 7. A file dialog box appears. Browse the file system for the USB stick and locate the install package of the printer. Run the application (printer driver). Follow instructions on the screen. 8. Upon completion the printer becomes available as an installed printer for Hemolyzer 5 9. Exit task manager (close)

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8 Installation 8.1 Check the Delivery When you receive the ‘Hemolyzer 5’ analyzer delivery, please ensure that the packaging is not damaged. Check the bill of lading accompanying the package against your order documents and ensure that the shipment is complete and that all documentation is in order. If you have ordered an optional Autosampler, it will arrive in its own package. Please contact your sales representative, service representative, or shipper if there are any discrepancies in the shipping documentation or any visible damage to any of the packaging. Please follow all applicable laws or regulations regarding the handling or opening of the ‘Hemolyzer 5’ analyzer packaging.

8.2 Prepare For Initial Installation Before you start the installation please ensure the following: • • • • •

8.2.1

Locate a suitable place for the ‘Hemolyzer 5’ instrument Identify any additional laboratory personnel that will observe the installation process Have the contact information for your Analyticon representative or service engineer Arrange for additional support (IT specialist, electrician, etc.) if necessary during the installation Understand and follow the analyzer General Precautions listed in section 2.2.

Select a Suitable Location

Select a location for the ‘Hemolyzer 5’ analyzer that meets your laboratory requirements for safety, ergonomics and efficient workflow. The location should also meet the environmental, electrical, and safety requirements of the ‘Hemolyzer 5’ listed in section 2. It is important to install the instrument in a suitable location. A poor location can adversely affect its performance. Consider the space and weight requirements listed in sections 2.6 and 2.7. To allow reliable operation and to provide a safe working environment, make sure that the table supporting the unit is stable enough to carry the weight of the instrument and accessories. Reagents should never be placed above the analyzer to avoid spill hazards.

8.2.2

Make Any Special Arrangements

If you decide to route the reagent tubing through the tabletop, please ensure that any necessary holes are drilled before the installation process starts. If you plan to connect the ‘Hemolyzer 5’ analyzer to any external devices (keyboard, mouse, printer, host computer, etc.), please ensure that all necessary preparations (cable-channels, cable-binders, drilling through tables, walls etc.) are complete before the installation begins.

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Hemolyzer 5 8.2.3

Gather Your Peripherals Devices

Collect any external keyboard, mouse, bar code reader, or printer that you will be attaching to the ‘Hemolyzer 5’ analyzer. Although the Windows® XP® Embedded operating system installed on the ‘Hemolyzer 5’ analyzer is capable of automatically recognizing multiple peripheral devices, please ensure you have available any installation disks or drivers provided by the device vendor. See section 3.4.7. to learn peripheral connections on the hardware block.

8.3 Performing the Installation Now that a location has been selected and all preparations are complete, you are ready to begin the installation. Initial installation should only be done by Analyticon certified service personnel. You can find the installation checklist in section 8.4.

8.3.1

Move the ‘Hemolyzer 5’ to the Selected Location

Always have two persons present and use safe lifting procedures when lifting the ‘Hemolyzer 5’ analyzer. Safely move the ‘Hemolyzer 5’ analyzer, the accessory box, and the optional Autosampler (if ordered) and the Autosampler accessories to the selected location. Keep the ‘Hemolyzer 5’ analyzer in an upright position and gently set it down in its new location.

8.3.2

Visual Inspection

Visually inspect the ‘Hemolyzer 5’ before proceeding with the installation and verify that: • The front panel is be free of cracks or scratches • The display screen is free of cracks or scratches • The top, sides, and back panels are free of dents or scratches Open the front panel of the unit and visually verify that: • The syringes are not cracked • The shear valve has the protective card installed • There is no fluid inside the tubing • There is no salt buildup inside the tubing Remove the side covers of the unit and verify that: • The tubes on the valves are in position and not popped off from (note that valve # 4 has a free connection) • Cables are not loose and they are well connected • The reagent puffers are not cracked and there is no salt buildup on their sides and bottom • Chambers are not cracked Visually inspect the Autosampler and verify that: • The outside housing of the Autosampler is free of dents or scratches • The transparent cover opens and closes smoothly • The sample tray and the sample racks have no visible damage

8.3.3

Remove the Protective Card from the Shear Valve

The shear valve comes equipped with a protective plastic card between the ceramic disks of the shear valve to prevent damage and adhesion during transportation.

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Servicemanual To remove the protective card, perform the following steps: • • • •

Open the front cover of the ‘Hemolyzer 5’ analyzer Locate the white protective plastic card in the shear valve as shown in 2. Figure. Gently pull out the card Check and tighten the locking screw of the shear valve if necessary

2. Figure: Shear Valve Protective Card

8.3.4

Connect the Optional Auto-Sampler

To connect the optional Auto-Sampler to the ‘Hemolyzer 5’ analyzer, perform the following steps: • • • • • •

8.3.5

Unscrew the five screws and remove the small cover plate on the right side of the ‘Hemolyzer 5’. Check that the connection surface is clean and there are no cables or other obstructions blocking the opening. Gently push the Auto-Sampler into the ‘Hemolyzer 5’ until the clamps are locked. Place the white racks with the tray into the Auto-Sampler. Close the Auto-Sampler's cover. Pull then push back the Sampler's tray to see that it can move front and back.

Connect the Reagents

Place the reagent containers as shown in section 2.6.

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Hemolyzer 5 Open the protective package containing the reagent and waste tubes. When connecting or changing reagent containers, please ensure that the reagent caps and tubes are protected and do not touch the floor or other surfaces. This can lead to contamination of the reagents and the ‘Hemolyzer 5’ analyzer. To connect the reagents to the ’Hemolyzer 5’ analyzer, perform the following steps: •

•

•

Push the color-coded reagent and waste tubes all the way on to the matching colorcoded reagent connectors on the back panel of the ‘Hemolyzer 5’ analyzer. o Green: Hemolyzer-Diluent o Orange: Hemolyzer-5-Diff 5P o Yellow: Hemolyzer-5-Lyser o Red: waste container Route the reagent cap and tube to the matching reagent container, ensuring that the reagent tubes are not bent, broken, twisted or blocked.

Place the reagent or waste tube in the matching reagent or waste container and screw the cap on to the container. Only genuine Analyticon reagents should be used with the ‘Hemolyzer 5’ analyzer The analyzer operates with chemically and biologically active reagents. Physical contact with these reagents should be avoided. Please read reagent descriptions carefully for possible emergency actions.

8.3.6

Connect the Power Cord

Before connecting the power cord, make sure that all of the ‘Hemolyzer 5’ back panel switches and the optional Autosampler switches are turned off:

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Servicemanual • •

Turn off the main power switch (small switch) on the rear panel of the ‘Hemolyzer 5’ analyzer near the power connection to the ‘down’ position labeled ‘0’. If the optional Autosampler is installed, turn the power switch on the right side of the Autosampler to the ‘off’ position labeled ‘0’.

Connect one end of the power cord to the power connection of the ‘Hemolyzer 5’ analyzer, and the other end of the power cord to an appropriate wall outlet. The ‘Hemolyzer 5’ analyzer should only be operated from a wall outlet capable of meeting the electrical requirements listed in section 2.4.

8.3.7

Verify the ‘Hemolyzer 5’ Computer Operation

We are now going to start up, then shutdown the ‘Hemolyzer 5’ analyzer to ensure that the computer system and software start and shut down correctly. To power and shut down up the ‘Hemolyzer 5’ analyzer, perform the following steps: • • • • •

8.3.8

Turn on the main power switch on the rear panel of the ‘Hemolyzer 5’ analyzer near the power connection to the ‘up’ position labeled ‘1’. Flip the power -on switch near the top of the rear panel of the ‘Hemolyzer 5’ analyzer to the ‘up’ position. If the optional Autosampler is installed, do not turn on its power switch at this time. Wait until 'Hemolyzer 5' boots up and the software loads. This will take a few minutes. Ensure that the software displays the main menu and that no warning or error messages are displayed. Warnings are displayed on the bottom of the LCD as a yellow exclamation mark. Shut down the ‘Hemolyzer 5’ analyzer. DO NOT simply turn off the power switches to shut down the ‘Hemolyzer 5’ analyzer. The analyzer requires a specific shutdown sequence. See chapter 7.3.2. in User Manual for information about the shutdown procedure.

Connect Peripherals

Ensure that the ‘Hemolyzer 5’ analyzer is completely powered down before connecting the peripherals. To connect the peripherals, perform the following steps: • •

• • • •

Plug in any external keyboard, mouse, bar code reader into the appropriate port on the back panel of the ‘Hemolyzer 5’ analyzer. If a peripheral device requires its own power supply, plug it in now in a wall socket belonging to the same socket group for proper grounding. Consult an electrician if you have any questions about wall socket grounding. Turn on the main power switch on the rear panel of the ‘Hemolyzer 5’ analyzer near the power connection to the ‘up’ position labeled ‘1’. Flip the power-on witch near the top of the rear panel of the ‘Hemolyzer 5’ analyzer to the ‘up’ position. If the optional Autosampler is installed, do not turn on its power switch at this time. Allow the computer inside the ‘Hemolyzer 5’ analyzer a few minutes to start and initialize the ‘Hemolyzer 5’ operating software.

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Hemolyzer 5 •

•

8.3.9

Perform the software installation of the peripherals devices. The Windows® XP® Embedded operating system recognizes most of the peripherals without additional installation steps. Peripheral devices that require additional installation steps must be installed by a Analyticon certified service engineer.

How to install a printer

Before making the printer install, prepare the printer’s driver files to an USB drive. Make sure that the driver files are for the printer you want to install. If the printer has an USB connection, there is a simple way to do the installing: • • • •

• • •

•

connect the USB drive containing the printer divers to the analyzer make sure that an external keyboard is also connected to the analyzer connect the printer to the analyzer via USB if windows supports the printer, after a few seconds, the printer install window should pop up. Windows recognizes the newly attached hardware and it starts the installing process automatically by popping up the install window. If you press the touch while the printer install screen is loading, the window will hide behind the 'Hemolyzer 5' software. Use ALT+TAB to switch between the two screens in the popped up printer install screen, browse the driver files from the pendrive add all the necessary printer driver files if needed if the files are added properly and install is finished, the printer will appear in settings, printer menu after „Refresh printer’s list” button is pushed (see user manual’s section 15.6). select installed printer and press save

If there is a problem during installing procedure or the printer install window is not popping up, there is a way to install printers from service, printer install menu.

There will be three options for installation: 1. complete setup with SETUP.EXE file from printer driver CD or pendrive. Windows install. Printer is not connected during installation 2. only driver installation with *.INF file. Will open Windows printer installation wizard procedure. Printer connected and turned ON during installation 3. only driver installation with *.INF file. Will open Windows printer installation wizard procedure. Printer is not connected during installation

8.3.10 Initializing the Optional Autosampler If the optional Autosampler is not installed, skip this section. To initialize the Autosampler, perform the following steps: •

Turn the power switch on the right side of the Autosampler to the ‘on’ position labeled ‘1’.

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Servicemanual • • • •

•

Make sure that the cover of the Autosampler is closed and that the ‘Cover’ led changes to green; Double click the AS state on the left side of the Status Bar at the bottom of the screen to bring up the ‘Autosampler info’ panel. Click the Reset button the ‘Autosampler info’ dialog as shown on the left figure below. The Autosampler performs a mechanical initialization. When this completes, ensure the HOME message and the currently installed software version appears as shown circled in red on the figure on the right below. Click the Ok button to close the ‘Autosampler info’ panel.

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Hemolyzer 5 8.3.11 Using the Settings Menu The settings menu allows modification of various system settings. Click the Settings icon on the Main Menu to bring up the Settings screen.

The Settings screen contains various buttons that allow the user to change system settings. Each screen contains a Back button and a Save button. The Back button returns to the Settings screen. The Save button save any changes made in the screen. If the Back button is clicked without clicking the Save button first, all changes made in the screen will be discarded. See description in the User Manual.

8.3.12 Set Up a Laboratory Information System (LIS) 'Hemolyzer 5' analyzer supports uploading of measurement data to an LIS or host computer. If your laboratory has an LIS system, the ‘Hemolyzer 5’ analyzer can be connected to it using a serial or an Ethernet connection. An LIS system is not required to operate the ‘Hemolyzer 5’ analyzer. Your LIS system must be configured to accept measurement results from the analyzer. ‘Hemolyzer 5’ uses the Analyticon 3.1 protocol to communicate over a serial connection, and the HL7 (version 2.5 or higher) to communicate over an Ethernet connection. See your LIS vendor to determine if your LIS system is compatible with the ‘Hemolyzer 5’ analyzer. LIS configuration requires a moderate level of familiarity with computer settings and some understanding of computer data communications. If you are not comfortable setting up the ‘Hemolyzer 5’ LIS connection, consult your Analyticon certified service engineer. Use the ‘External devices’ button in the Settings screen to set up LIS connection options.

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8.3.13 Set Up a Serial LIS Connection To connect the ‘Hemolyzer 5’ analyzer to an LIS system using a serial LIS connection, perform the following steps: • • •

•

• • • • •

Ensure that your LIS system is compatible with the Analyticon 3.1 protocol using a serial connection. Connect a serial cable (null modem or modem eliminator) between the COM 1 port on the back panel of the ‘Hemolyzer 5’ analyzer and the host system. Select the appropriate ‘Sending port baud rate’ on the ‘Hemolyzer 5’ ‘External devices’ screen. o Select 9600 baud if your serial cable is longer than 5m (~15’). o Select either 9600 or 115200 baud if your serial cable is shorter than 5m (~15’). Check the ‘Automatic LIS’ check box if you want every result to be transmitted automatically to the LIS. Uncheck if you want to manually select and transmit database records to the LIS. Uncheck the LIS check box. Uncheck the ‘Bidirectional LIS’ check box. Click the Save button to save your changes. Click the Back button to exit the External devices screen. Configure your LIS system to accept measurement results from the ‘Hemolyzer 5’ analyzer using these settings.

A copy of the ‘Hemolyzer Communication protocols’ description is available from your sales representative or by download from the Support section of the Analyticon web site (http://www.analyticon-diagnostics.com/en/service_and_support/partner_sign-in.html).

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Hemolyzer 5 8.3.14 Set Up an Ethernet LIS Connection Connecting the ‘Hemolyzer 5’ analyzer using an Ethernet connection requires connecting the analyzer to a local area network. Consult your IT administrator about connecting the ‘Hemolyzer 5’ analyzer to the local area network of your laboratory. The ‘Hemolyzer 5’ analyzer is configured at the factory to “Obtain an IP address automatically.” If this setting is not suitable for your local area network and must be changed, only a Analyticon certified service engineer can complete the installation. To connect the ‘Hemolyzer 5’ analyzer to an LIS system using an Ethernet LIS connection, perform the following steps: •

•

• • • • • •

Ensure that your LIS system is compatible with the HL7 version 2.5 protocol or higher using an Ethernet connection, and has been configured to accept ‘Hemolyzer 5’ compatible HL7 messages. Check the ‘Automatic LIS’ check box if you want every result to be transmitted automatically to the LIS. Uncheck if you want to manually select and transmit database records to the LIS. Check the LIS check box. Enter the IP address of the LIS host computer. Enter the Port of the host computer. Click the Save button to save your changes. Click the Back button to exit the External devices screen. Configure your LIS system to accept measurement results from the ‘Hemolyzer 5’ analyzer using these settings.

8.3.15 Running Blank Samples and Blood Samples for the First Time The ‘Hemolyzer 5’ analyzer requires a blank measurement to be run every day before the analyzer will allow you to run blood or control samples. This measurement is also called Background which indicates that the system is clean and ready to measure blood samples. The transportation and packaging process sometimes causes minor particles to be present in the pneumatic components of the analyzer. For this reason, five to ten initial blank measurements should to be run during installation to flush the system. Click the Measure icon on the top left side of the screen and run a blank measurement. The Start button will change color to red. The fill procedure and blank measurement take several minutes to complete. The start button will change color to green and the blank result screen will be displayed. After the procedure completes, a blank result screen will be displayed. Click the ‘Start Again’ to run an additional blank measurement. Repeat this procedure several more times until the blank results are no longer flagged, or until the blank results are low enough to satisfy laboratory quality standards. If the Blank measurement is satisfactory, press Accept to make other measurement modes enable. Change the mode selector to Control and run a control measurement to see that the sample results are correct. It's important to use a valid, not expired control sample with known target values and ranges. See chapter 12 in User Manual for additional information about QC on the ‘Hemolyzer 5’ analyzer.

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Lastly, it's possible that a calibration procedure is needed on the ‘Hemolyzer 5’ analyzer. See section 11 in User Manual for additional details regarding ‘Hemolyzer 5’ calibration.

8.4 Checklist for installing Hemolyzer 5 hematology analyzer 1. Open the box, carefully take out and place the analyzer on a flat surface. The table or desk should be able to bear at least 50 kg. 2. If the analyzer was stored in a cooler place than room temperature, allow 2 hours for acclimatization, otherwise water condensation may happen. 3. Check the analyzer visually. Make sure that there is no visible damage. Open the front cover and remove the side covers to check the electronics and the tubing. Replace the covers when done. 4. Remove the plastic card from the Shear Valve and check tightness of the locking screw. 5. If you have an Auto-sampler unit, remove the plate which covers the AS docking connector (from the right side cover) and connect the Auto-sampler to the unit. 6. Place reagents preferably on lower level than the analyzer (max. 1 m difference). Never place reagents to higher level than the unit itself! 7. Assemble and connect reagent and waste tubes to the corresponding containers and connectors. 8. Connect the power cord. 9. Turn on the analyzer, turn on and initialize the Auto-sampler. 10. Connect other peripherals if needed (keyboard, mouse and printer).

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Hemolyzer 5 11. Check that all the software adjustments are proper. Use setting menu to adjust the software according to the customer needs. Set the LIS connection (if the laboratory has any). 12. Check that all the hardware adjustments are proper. Use service/service testing menu to run or test the pumps, valves and motors. 13. From ’Diagnostics/Self-test’ click on ’Start both’ button and wait for the result. 14. Click on ’Measure’. Pneumatic initialization and „fill” cycle will start. Automatic background cycle will be performed (at first startup several blank runs might be needed till the results are acceptable) After two or three blank measurements, results should fall within the acceptable range, see section 22.7.9 in User’s manual. 15. Run a control blood in ’Control’ mode or run QC procedure. 16. Check if results are within the acceptable range. Run calibration if necessary. 17. The Hemolyzer 5 is ready for routine measurements.

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9 Troubleshooting This chapter will show how to do a step by step troubleshooting on the 'Hemolyzer 5' analyzer. Following the troubleshooting process ensures that the problem can be identified without making any harm on the system. This chapter will helps find the root cause of the problem and navigate to the page where you can find information how to solve the problem.

9.1 Troubleshooting checklist for Hemolyzer 5 hematology analyzer 1. Visual inspection 2. Powering up the system 3. Checking software adjustments 4. Checking hardware adjustments 5. Run a Self-test 6. Run a Blank measurement 7. Run a Control measurement

9.1.1

Visual inspection

The first step during troubleshooting is to check the instrument visually. Some problems can be easily defined visually before any sample run test, measurements or even to power up the system. 1. Check the front panel and the two side panels; look for scratch or any other damage. 2. Check the back panel of the analyzer, see that the reagents are connected properly, the tubes are not misplaced. 3. See that the power cord is connected to the analyzer and plugged into the wall socket. The power supply main switch is flipped to off position. 4. Open the front cover and remove the two side covers. See section 11. 5. Make sure that the tubing are not popped off from the valves, the chambers and reservoirs are not cracked, there is no liquid on the bottom of the instrument and there are no salt buildups around the pneumatic system. Check tube between blood sensor and shear valve, see that the tube is transparent and not whites or has any other color. Replace the tube if it's not clean or transparent enough. If tube was moved or replaced, the blood sensor and the sampling values should be realigned. Please see section 6.4 and 6.5 to learn how to calibrate blood sensor and sample position. Other tube color changes are not so critical, but if there is a tube in the system with a very huge pigmentation, it should also be replaced. Please see tubing map in section 11.16. 6. Check all cable connections. Make sure that the cables are in position on the LSDACQ, PPB boards, HVB panel and the valve PCB boards. Replace any damaged cable.

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Hemolyzer 5 9.1.2

Powering up the system

After the visual inspection, it's time to see that the analyzer can turn on properly. Please follow the steps below: 1. Make sure that the power cord is well connected to the analyzer and that the socket can provide the proper electric power. Turn the power supply's switch to on position and check that the power indicating LED on the motherboard is on. If the LED is not on, please check the power cord. If the cord is ok, we must assume that the power supply is not functioning. 2. Flip the power-on switch on the top back of the analyzer to turn it on. Check the five green voltage indicator LEDs on the LSDACQ. The five LEDs show that the necessary voltages are present. If one of the LEDs is not lit, check power supply cable or replace LSDACQ board if needed. 3. Wait until Windows and the High Level Software of the analyzer loads. If there is a problem during the boot process or the analyzer's software cannot load, please see section 7.5.1. 4. There is a short audio welcome signal played by the analyzer after the software has loaded. If you can hear the sound and the software screen is present on the display, then the powering up was successful. If the display is showing windows, but not the High Level Software, please see section 7.5.

9.1.3

Checking the software adjustments

Setting the software is important to make proper measurements. Every 'Hemolyzer 5' software was set by Analyticon, but in some cases (windows recovery, high level sw reinstall) this setting has to be done again or at least has to be checked. 'Hemolyzer 5' analyzer has two software levels. The High Level Software is responsible to communicate with the user and to give the user's commands to the Low Level Software. The Low Level Software receives the User's commands and controls the pneumatic and mechanics system of the analyzer. After low and high level analyzer software is loaded, check the following: 1. On the display, the High Level Software is present; the start button on the front panel is lighting orange. If the start button is off, it means there is no communication between the two software levels. See section 7.5 for communication error. 2. Enter to Service menu by entering the service password ‘6484A5’, then go into SW upgrade screen. Press Refresh data. After a few seconds the analyzer should show all the software and firmware versions in the system. Make sure that the analyzer has the same version of the Low Level Software and High Level Software installed. If there is a problem occurring during Refreshing data, please see section 7.3.10. 3. The software gives a warning mark if there is a problem noticed by the system. This is shown as an exclamation mark in a yellow triangle on the bottom of the display. Double tap on the mark shows the details of the problem. By pressing 'Go to' button, the software brings up the screen where the problem can be solved. See section7.2 for detailed warnings.

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Servicemanual 4. Go to Service Functions screen in Service menu. Check that the necessary checkboxes like blood sensor status and windows control are enabled. If blood sensor is disabled, please ask the user about the reason. For blood sensor settings, please see section 6.4. 5. Go to Adjustments screen in Service menu. Check that the Auto-offset checkboxes are enabled in Optical measurement offset and Impedance amplifier offset fields. Press 'Read data' to see that the offset values are close to 0. Note that if 'Read data' is pressed, the start button will turn to red, indicating the communication line between the two software levels are busy reading the offset values. During the reading, no other commands can be done by the analyzer. Make sure that the 'Stop data' button is pressed to stop continuous reading of the offset and make the communication line free again. If offset values are very high during the reading and auto-offset cannot lower them, it shows an offset error in the LSDACQ. This board has to be changed in this case. Check that WBC preheater value is 375 (37,5 °C). Press 'Read data' to see the current temperature of WBC preheater. If the value is ok, press 'Stop data'. Press Start adjustment at Pressure sensor adjustment. Adjustment will take the few seconds. The start button will turn red to indicate that the system is busy. After the adjustment is done, check that all three offset results are in range. The values shouldn't be higher than 20 mBars. If one of the values is higher, replace the pressure sensor board. 6. Go to Auto Alignment screen. The system will ask a password, press cancel to enter without giving the password. In this case, the password protected setting will be unable to adjust. Check laser power, low level and high level gains. These are Laser Optics related values. Changing one of them influents the WBC differential population positions on the scattergram. These are factory defined values for the optical head and they should match to default setting of Laser Optics in analyzer.

9.1.4

Checking the Hardware adjustments

The proper settings of the mechanical parts are important to make good measurements and to increase the lifetime of the system. The mechanics are aligned by Analyticon during production but some realignment may need when some mechanical parts are replaced or repaired. These parts can be checked by Service testing menu. 1. Press all 40 valves on. Check that every valve can turn on and off. Make sure that every valve can be turned on together, than press 'All off' to turn them off. If one of the valves is not responding, try to replace it with a new one. See section 7.3.2. 2. Press shear valve to Needle position (NP) and Chamber position (CP). Check that the shear valve discs can turn to the correct position without any grinding noise and that there is no pneumatic error during the test. For problems related to shear valve, see section 6.2. 3. Turn the sample rotor In and Out. Make sure that the front cover and the washing head is not in the way. If you receive a pneumatic error, see chapter 6.1.

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Hemolyzer 5 4. Press 'Rear' and 'Front' buttons at MHori test to move the needle back to the AutoSampler station and back to sample rotor position. Listen the sound of the mechanics, if there is a grinding noise or a pneumatic error, please see section 6.1. 5. Press 'Down' and 'Up' buttons to see that the needle can move down and up properly. Check that there is not noise during the movement; the moving mechanics parts are not hitting the not moving parts. See that the opto LEDs can indicate the needle positions properly. See section 6.1.2 for alignments. 6. Press 'Up' and 'Down' to all Dilutors. Check visually that the syringes can reach the top and bottom positions without any problems. Look for micro bubbles at the pistons and for leakage at the syringes. If there is a problem with a syringe and it needs to be changed, see section 6.1.2. 7. Go to Service Functions screen and press 'Wash head' button to see that the position of the washing head is proper. The system wants you to confirm that you want to make a washing head position checking/setting, press 'Ok'. If it is in a good position press 'OK' to make a mechanical initialization of the XY unit. Press 'OK' when it's done. See section 6.1.3 for alignment information. 8. Checking the needle's position. There is two way to see that the needle is in a good position. o

Move the needle down manually without using the software. If the needle is in down position, check the distance between the end of the needle and the sample rotor's plate. The distance should be around 1mm.

o

In Service functions screen, press the 'Needle' button. The system wants you to confirm that you want to make a needle position checking/setting, press 'Ok'. The system moves the needle up, the needle tip is inside the washing head. If the needle is set correctly, the end of the needle should be hanging out from the washing head. Press 'Ok' if it is aligned well.

For needle setting procedure, see section 6.1.4.

9.1.5

Run a Self-test

Self-test can be run In Diagnostics menu. This test is fast and automatic, very useful for troubleshooting. For proper functioning of the analyzer, a Passed selftest is as important as like a clean and acceptable Blank measurement. For selftest results see chapter 16.1 in User Manual. If selftest is Failed, please see Self-test guide in section 7.1.

9.1.6

Run Blank measurements

The Blank and sample measurement provides valuable information about the fluidics and electronic system, but some setting may need to receive the information in Database: 1. If Database only provides those parameters that are important to the clinicians, the Database parameter setting must be changed. In Setting menu go to System and press 'Set'. Please add extra columns to the database. Make sure that the following columns are added.

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PrV RBV

o

PrV WBC

o

Warnings

o

Gravity X

o

Gravity Y

o

Woc 4

o

Woc B

Select these columns and add them from the right to the left column block then press Accept and Save. If you don't press save the setting were not made and the result columns will not appear in the database. 2. Perform Blank measurements. NOTE: If it's the first measurement after startup, the system makes an init process, a wake up process and Rinse process. If there was an improper shutdown before, the system also asks for cleaning. These processes can increase the time of the troubleshooting and reagent consumption. That’s why it can be bypassed if you type in the suitable code (66-69) in Service functions on Test functions field. See test functions at section 7.3.1.1. Type in the required test function's number and press 'Run test'. If it is done, the Blank measurements can run without any other requirements. 3. If a blank measurement is ready, please check that the result is not flagged with warnings. Check probe voltages. RBC probe voltage (PrV RBC) should be 10-13 Volts, WBC probe voltage (PrV WBC) should be 20-27 Volts. If there are problems with probe voltages, replace apertures, check measuring chamber and preamplifier; see section 11.12. If the blank measurement is stopped with a pneumatic error, troubleshoot as a displayed error codes, see section 7.2. If there is a problem with popping off tubing in the system, see section 11.16.

9.1.7

Run Control measurements

Finally, a measurement with a sample is the most complex testing from all. A measurement gives information about sampling, calibration, nonfunctional modules, clogged tubing or valves. Measurement with blood sample and please check the following: 1. The control blood needs to be run in control mode. Please select proper mode. 2. The control blood shouldn't be expired and should have an exact target and range for all values. 3. During sampling, please check visually if the sample position is proper at the shear valve. Please see section 6.5 to learn more about sampling and setting sampling position. 4. After a measurement is done, check the steps below: o

The results of the control are in range.

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Cell numbers (Woc 4, Woc B) are proper on normal control. Woc numbers (White blood cell Optical Count) indicates how many cells are present during optical measurement. These values have only minimum number. 

Woc 4 min : 2.72



Woc B min : 5.44

o

Gravity values are close to the target. Improper or unstable gravity values can indicate a calibration or an optical head problem. Scatter calibration must be performed. See section 7.3.3 to learn more.

o

Ignore probe voltages during Control measurement. Probe voltage values are different in Control mode. To check probe voltages, use Blank or Human mode.

o

Check that impedance measurement results are proper and close to target. If there is problem with the results, make a calibration (User Manual section 11) or replace appropriate part of measuring unit (section 11.12).

o

Check HGB result. HGB is accomplished by a photometric measurement technology. Incorrect HGB result can be caused by dilution or mixing failure in the WBC chamber. Whole WBC (impedance) count is also incorrect in this case. But it's not related to the apertures and to amplifier board. If there is a problem with HGB results, please clean the measuring chamber and replace the HGB head; see section 11.12.4.

o

The WBC differential (Ly, Mono, Neu, Eo, Baso) % results are within the limits, the values are close to target. If there is a problem with the scatter, please do a scatter calibration, see section 7.3.3, replace the injector in the optics, see section Hiba! A hivatkozási forrás nem található..

5. Do measurements from the Auto-Sampler if it is attached. Make sure that the sampler can move in X and Y direction and that the sample position is proper. See section 7.3.6. to learn more about the Auto-Sampler settings. If the analyzer still has a problem despite of all the points of troubleshooting, please contact Analyticon Support Team. [email protected]

9.2 9.2.1

Mechanical problems

General guidelines to overcome motor or moving part related problems

Make sure to follow this simple sequence to be able to locate sources of errors and to resolve problems easily and correctly. • •

Always make sure that the part with the problem can be moved freely and easily. Make sure that there is enough (and not excessive) amount of lubricant on the moving parts.

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9.2.2

Test the motor with the built in functions in service testing menu. It will always try to operate all sensors, and will drive the motors with necessary current and power. Any Setting or adjusting (mechanical, opto sensor) should be done only after the previous steps (cleaning, lubricating) did not solve the problem.

Sample Rotor (SR or BOB) failures

9.2.2.1 SR gives grinding noise and / or SW displays SR error messages • •

•

The front panel alignment is not good. The front panel is not closed properly, the opening does not match with the sample rotor door. Fully open or close the front panel to observe correct shear valve operation. There is liquid in the SR. If you can see traces of salt around the SR, then the switches might have gotten damaged.

9.2.2.2 SR error appears during initialization process: • • •

Sample adaptor is removed from proper position. The cable of the SR is damaged, or not connected, or connection is not good. The motor is not working at all. Check motor cable and/or replace the motor.

9.2.2.3 The SR does not turn into the analyzer even with open front panel • • •

9.2.3

The SR door got stuck in the wash head. The wash head needs to be aligned correctly. Micro switches are not functioning inside the SR. Faulty switch needs to be replaced. PPB board is not controlling the rotor. PPB board replacement needed.

Needle mechanics, Vertical motor (MVert) problems

9.2.3.1 The needle carriage keeps dropping back (down) at initialization •

•

The wash head position -relative to the needle and to the SR- is not correct. The wash head comes down too much, and even if lifted, leaves no room for the SR door to turn. Make sure that the vertical rod holding the wash head (if removed or modified) is inserted correctly.

9.2.3.2 MVert cannot reach the optosensor (Up or Down) •

• • •

The wash head (when lifted) gets physically blocked by the non-moving parts of the needle carriage (needle holding block). Set wash head, see washing head adjustments in chapter 6.1.3. The grip of the needle on the timing belt is in a wrong position. Set the needle and timing belt connection. See chapter 6.1.2.2. The opto sensor is damaged, or the light path is blocked. Use a screwdriver, or a piece of paper to verify operation. The timing belt is damaged or became too long, or got torn. In this case the XY unit has to be removed and the belt should be replaced.

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Hemolyzer 5 • •

•

9.2.4

The motor gives a strange noise (not “smooth”) even when moving. Check cable or connection problem The problem comes up only when using Stastedt (or similar) sample tubes from sample rotor. This could happen because the system is set to pierce a monovette type of tube, not a Stastedt or the incorrect setting of opto flags on horizontal movement. In this case test that the motor (carriage) can move freely and run MHori tests. Make sure that the needle height is set correctly. See chapter 6.1.4. The problem comes up only when using Stastedt (or similar) sample tubes (AS position) because the tube holders are not working properly. Check operation of the tube holders. They must operate symmetrically, both tube holders should move easily and make sure that the rack can move in and out freely. Also check that needle height is set correctly.

Shear Valve (SV) related errors

9.2.4.1 SV error at the first startup •

•

The SV cannot turn. Make sure that the pull tab has been removed, check free movement of the upper disc and check operation of opto sensors by blocking the light path with e.g. a screwdriver. The SV is stuck because the last draining or preparing for shipment process was not performed or it could not be finished. See that the motor can move the valve and it is not blocked “solid”. Try to loosen the central screw closing the two disks and try to move the motor a few times in service testing menu. If it does not help:  use warm water to wet the side of the SV (to make some liquid get in between the disks)  you can also dip the SV into water if you can  gently force it apart

9.2.4.2 Grinding noise after SV cleaning, (after SV reinstallation) •

•

The upper disc cannot reach opto position. In this case DO NOT adjust the optosensors! See that lower disc is aligned correctly – loosen the fixing lever, and reseat the lower disc. See section 6.2.1. Check that the middle rod on the back of the upper disc is positioned between the two moving nods. See section 6.2.2.

9.2.4.3 SV leakage •

•

The upper disc is not sitting well on the lower disc. Disassemble the shear valve, clean the internal surface. Small particles or dirt can be stuck between the two discs, making a gap between the ceramics causing a flow. The closing screw is not sitting completely on the upper disc. Remove than replace the screw properly. Make sure there is no gap between the discs.

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Servicemanual 9.2.5

Dilutor errors

9.2.5.1 Dilutor is making noise • •

Dilutor pistons are not attached correctly to the dilutor’s moving part. The piston has a different size hole on the bottom; the larger hole has to face the instrument. One optosensor on the dilutor PCB is faulty. Try to move the dilutor up and down in Service Testing menu. If noise is still present, replace the dilutor unit.

9.2.5.2 Dilutor is leaking • •

9.2.6

The syringe or the top plastic of the syringe is cracked. In this case replace syringe. The “ribs” on the pistons are filled with liquid and they are white. The piston is leaking; the whole syringe with piston should be replaced or greased with silicon grease. Do not grease the black pistons, just replace them if needed.

A tube comes off of a valve

Depending on the location (ID) of the valve, it can be caused by: • • • •

• •

One of the valves are not opening well. Check all of the valves in Service Testing menu. Replace the valve which is not responding. Shear valve discs are not aligned well. Adjust the shear valve, see section 6.2. Tube on the valve is too wide. Cut off the end of the tube and reconnect it to position. TCU tubing is blocked. Drain the TCU by using the option is Service Functions menu. Fill TCU and see that the clogging in the TCU is removed. If the TCU tubing is still blocked, remove the TCU and check the tubing inside. Laser flow cell is clogged. Perform a flow cell cleaning by software or manually. One of the chambers is clogged. Remove the metal plate from the side of the chamber and clean it. Don't forget to drain the chambers in Maintenance before removing the front of the chamber.

If a tube comes off from a valve, it can be useful to check the tubing schematics. See the tubes connected to the valve, follow the route of the tubing, note that the valves involved were open or close state when the tube popped off. Also see shear valve position when tube pops off. By using the schematics and following the route of the tubes, it is possible to find the clogging in the system.

9.2.7

Priming problems

9.2.7.1 The analyzer would not prime liquids • • • •

The respective reagent is out. Check the reagent status bar on the bottom. Change reagent if needed. The reagent tubing is not connected to the proper inlet. Check both ends of the tube. The reagent tube is bended or broken. Check the tube. Tube popped off from a valve. It will make the vacuum level dropping immediately, so priming won’t be successful. Reconnect the tube.

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Hemolyzer 5 • • • • •

9.3 9.3.1

There is not enough vacuum to fill up the reservoirs. Check all the valves in Service Testing menu. Replace faulty or non-opening or closing valves. The pressure sensor is faulty. Check sensor offsets, see section 6.6. Reagent buffer reservoir is cracked and vacuum is escaping. Replace the reservoir. The float is not moving when the reagent is filled. In this case the float sensor is stuck to the bottom. Gently touch or tap the buffer to make the float free. The reservoir is full, priming doesn’t stop, but the float is not sensing, even when it’s on the top. In this case the reagent sensor board or the float sensor is damaged. Reset the Low Level Software to stop priming and locate the reagent sensor board. See that the LED is sensing the float’s signal, or connect the buffer’s cable to another pair of pins. See that the LED is on. If LED is on, the float is ok and the board can be faulty and it has to be replaced. If the LED is not turned on, the float is faulty and the reservoir needs to be replaced.

Electronics related problems Touch screen / display errors

9.3.1.1 No image on display • •

Display is white. LVDS data cable is removed from the touch screen or from the motherboard. Reconnect the cable. Screen is black. Check the cables behind LCD and on the mother board. See that BIOS settings are not modified to use different display device. See chapter 7.5.1., BIOS settings, Chipset/North Bridge/Onchip/Select Display Device.

9.3.1.2 Touch sensitive surface not working •

•

When touch is not responding, it can happen that the sw is frozen or the display is faulty. The touchscreen PCB is located on the back of the LCD. Remove the cover of the PCB and check the board and the cable connection. Connect external USB mouse to the unit and check that the mouse cursor is available and moving. If mouse is ok, remove and reconnect the Touch USB cable.

9.3.1.3 Touch (click) is inaccurate •

Connect external USB mouse and select touchscreen calibration in Maintenance menu.

9.3.1.4 Screen image is not normal, some parts of the software screen is not visible •

•

The analyzer uses a resolution 600x800. If there is a problem with the size of the screen check the resolution in Windows. Leave the High Level Software by pressing CTRL+ALT+DEL to enter Windows (only if Windows control checkbox is enabled in Service Functions). It is also possible that the resolution of the screen was changed in BIOS. Enter BIOS and check the resolution in Chipset/North Bridge/Onchip/Select Display Device.

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Servicemanual 9.3.2

Communication errors

Check the communication by going into Service menu/Sw Upgrade and press Refresh button. If communication is ok, all the available firmware and software will be listed. If there is a problem with communication, the unit will send message “Pneumatic error” or “USB communication lost”. •

•

•

•

•

9.3.3 •

•

•

In most cases, the communication problem is created by the DimmBoard. All the electronics are working well but the data cannot access the low level software. In this case check the DimmBoard, locate the SD card inside the board and make sure that it’s not removed. Remove the DimmBoard from the LSDAQCQ, clean the connection surfaces and put it back. Don’t need to turn off the unit, just restart the Low Level Software in Service Functions. The Low Level Software will automatically turn on and start communication, when the connection is available again. Check the start button. If it is red all time, it means the low level software is frozen or stuck in an infinite cycle. Go to Service functions screen and restart/reset the low level sw. See section 7.3.1. If start button is blinking, the communication error is related to the Pneumatic system. Open the valve block door and locate the two PPB panels. Check the cable connections; replace the small PPB CON panel on PPB1 (left). If communication is still not ok, replace the PPB CON panel on PPB 2 (right). If the problem still not solved, replace PPB1 and then PPB2. The error message “Unit is not present” will notice that the communication line inside the unit is broken. The line is a closed BUS between the LSDACQ (DimmBoard), the TCU, the pressure sensor, the optical head and the front panel (touch). If one of these are damaged or not connected by USB cable, the system gives a message about which unit is present or not. Locate the faulty unit and see that the power supply is attached to it and check all their cables. See section 9.3.4.

The analyzer does not power on If the analyzer is connected to the external power source and the main power switch is on, an indicator LED on the motherboard should turn on to show that the power supply is working. If the LED is not on, the power supply has to be changed. Remove the hardware module from the analyzer and change the power supply. If the LED is on but the unit is not starting, the problem can be the motherboard or the power-on switch. Follow the power-on switch’s cable to the motherboard. Remove the cable from its position. Try to power on the motherboard by applying a short circuit on that specific jumper of power-on switch with a screwdriver. If it starts, then the switch is faulty. There is a “beep” sound coming from the instrument. Typically the motherboard gives this sound if the board itself has a problem starting up or the memory card is not in place. Locate the memory card and check its position. Replace motherboard and/or memory card if necessary. The power supply works, the motherboard starts, but the system would not boot up. If high level sw and windows cannot start, the operation system has to be reinstalled or recovered. See section 7.5.1.

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Hemolyzer 5 •

9.3.4 • • • •

9.4 9.4.1

The power supply works, the motherboard starts, windows starts, but the User interface SW does not start (just widows desktop appear). In this case the instrument doesn’t have a properly installed High Level Software. Contact the Analyticon support via [email protected] to get the right software. Copy the software to a pen drive and insert it to the instrument. See software installation in section 7.5. Make sure that the Low and High Level Softwares are the same version.

I2C errors displayed at startup Check the power and data connection of the board reported missing Most probably the power connector of the missing module is disconnected The second most likely cause is a misconnected, or not connected data cable A missing TCU power cable can cause a “multiple” I2C error when more than one modules are reported missing. Check the power connection of the TCU module

Useful information and tips High PLT background

After shipping it's possible that the PLT background is higher than normal for the first few background runs. • If the PLT level is not normal after a few runs, use a syringe to put Hypoclean CC inside the RBC chamber and leave it there for a few minutes. Than make stress measurements. • 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, and then rinse with clean distilled water or diluent. It can avoid the bacteria to grow inside. • If tank is open – and cap is not installed or closed - external dust can make reagent dirty. • Use stress measurements to find out that the problem is dirt inside the aperture or it is noise. If the stress results are high but slowly decreasing, it most likely dirt inside the RBC chamber. If results have a large diversity, it's caused by noise.

9.4.2

Fast Starting up and Shutting down

During troubleshooting, it is possible that the unit needs to be turned off and on multiple times. Before shutdown, the unit has to make a cleaning process and after an improper shutdown, the instrument requires a cleaning process when turned on again. The cleaning procedure is not always necessary during troubleshooting and it can take a long time. The cleaning procedure can be skipped by running program code 66 in Service Testing menu. Run this program before shutdown to make it faster and to skip the cleaning process run the program before running background measurement.

9.4.3

Removing bubbles from the Flow cell

The flow in the flow cell is very critical during the measurement. If bubbles appear in the tubing system (the 4 meter tube and the flow cell), it can make improper scatter values. The easiest way to check the amount of bubbles is to press valve #1 and #20 together. This will start the flow inside the 4 meter tube; moving bubbles can be noticed easier. To start the flow

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Servicemanual in the flow cell, press valve #1 and #32 together and check the laser waste tube for bubbles. If there are too many bubbles in the laser, check the tubing and "T" connections in the tubing at valve #20 and #32. If bubbles are leaving the laser but not entering into it, the injector must be cracked. Remove the laser and replace the injector.

9.4.4

Removing the DimmBoard

There is no need to turn off the instrument to remove the DimmBoard. Go to Service Functions menu and press ‘Low Level Reboot’ button. After a few seconds, the start button will turn off which means the low level sw is turned off to reboot. It is possible to remove the DimmBoard or the SD card while the Low Level Software is off. After a few seconds, the software reboots and the communication will return. If there is not DimmBoard in the LSDACQ, the communication will be lost until the board is replaced. After replace, it is possible that the system needs a Low Level Software reboot to wake up.

9.4.5

Listen the sounds of the instrument

The unit keeps repeating the same process during measurements. The sound of the unit is very telling and can warn the user or service engineer that something is not working properly. It is also useful to put your ears on the front panel and listen the mechanics. Some noise can be discovered easier this way.

9.4.6

Replacing small diameter tubes

Some tubes in the unit are connected to a small plastic 'T' fitting. Replacing these tubes can be difficult because the tube's diameter is smaller than the fitting. In this case a thin metal rod can help putting back the tube to position. Put the rod's end into the 'T' fitting while the tube is on the rod. This way the fitting will not broke while the tube is pressed onto it, because the metal rod is keeping it on position from inside.

9.4.7

Swapping the pumps

For troubleshooting, it can be useful to swap the two pumps. The instrument can work when the two pumps are interchanged. It's not necessary to remove the pumps, simply just remove pump 1 cable from PPB1 and pump 2 cable from PPB2. Connect pump 1 (outer) cable to PPB2 and pump2 (inner) cable to PPB1. After this, also change the tube connections next to the reservoirs. By this it's possible to find out which pumps has problems. Self-test results can help.

9.4.8

Draining the reservoirs

If there is a problem with a reservoir and it needs to be changed it has to be drained first. Draining is made by the unit automatically by pressing drain in Maintenance menu. To save time, it is possible to remove the tube from the top of the reservoir. The ambient air pressure will push the reagent out from the reservoir faster than the draining procedure. Use this only when reservoir needs to be replaced.

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Hemolyzer 5

10 Maintenance 10.1 User maintenance 10.1.1 Daily maintenance Hemolyzer 5 requires automated maintenance during daily routine. It is a user maintenance. At the end of day a system cleaning procedure is recommended. To perform this cleaning, prepare a vial containing 2-4 ml Hemolyzer-Hypocleaner and place it in the Sample Rotor. From Main Menu go to: Maintenance/Functions and press Clean. This will initiate a cleaning cycle, all chambers, needle, shear valve and the TCU is cleaned with diluted HemolyzerHypocleaner, than the system is rinsed with diluent.

10.1.2 Weekly maintenance Weekly maintenance is for cleaning salt build-up from the most contaminated surfaces. It is recommended to clean the Shear Valve and Needle Wash head after every 1500 samples.

10.1.2.1

Shear Valve cleaning

This procedure is detailed in User Manual section 17.6

10.1.2.2

Cleaning the wash head

This procedure is detailed in User Manual section 17.7

10.2 Preventive Maintenance The procedures in this section are service maintenance. Preventive maintenance frequency depends on the daily workload of the customer. In the Hemolyzer 5 User Manual and Service Manual the maintenance interval of moving parts and syringes is determined as to be done after every 30.000 measurement cycles or twice per year. As a general rule, at least 1 maintenance per year must be performed to ensure correct functioning and performance according to specification. Analyticon recommends the following frequency for preventive maintenance by field service: - for instruments with a workload of up to 100 samples/day Preventive maintenance by field service should be performed once per year - for instruments with a workload between 100 and 200 samples/day Preventive maintenance by field service should be performed 2 times per year - for instruments with a workload above 200 samples/day Preventive maintenance by field service should be performed at least 3 times per year To do list and materials needed for a preventive maintenance intervention

130

Servicemanual Note: there is no difference between the „6 months” or „1 year” preventive maintenance. The same maintenance protocol must be followed and applied every time. Procedure Duration: ~ 2 hours Tools needed: -

hex screwdrivers (1.5, 2, 2.5, 3, 4) torx screwdrivers (2.5, 3) philips screwdriver (2) small size flat screwdriver forceps tweezers syringe (at least 20ml)

Materials needed: -

silicone grease (P/N: A599) teflon grease (P/N: A598) bleach (~200ml, Hemolyzer-Hypocleaner) distilled water, ~500ml paper towels compressed air required protective safety equipment (gloves, lab coat, glasses, etc.)

Spare parts needed: Maintenance KIT for A5 Contains: Part number

Description

Quantity

A5330

Washing head Hemolyzer 5

1

A543

4/1.8 Tygon tube, 1 m

4

A5433

1,27/2,23 Tygon tube (type: S 54-HL)

1

A5439-S

0,78/2,38 Tygon sampling tube for A5, 26 cm

1

A5-AJN014

Piercing needle (Hemolyzer 5)

1

AP251

SCHOTT syringe with piston white (mounted, 2 ml)

6

J5P251

Schott syringe with piston black (mounted, 2ml)

2

Suggestion of spare parts which are good to have but not necessary at a PM visit:

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Hemolyzer 5 -

RBC/WBC Chamber RBC/WBC Aperture 2/2 Valve with Coil 3/2 Valve with Coil Pressure sensor board

J5P421 J5P431 A504 A505 A5519

Preventive Maintenance Protocol: 1. First steps / Checking the state of the analyzer 1.1 turn on the analyzer, run background and check if values are within accepted range 1.2 run Self-test (electronic and pneumatic), if it is „successful” check if any value is close to the accepted limit, if it is „failed” troubleshoot accordingly 1.3 in case of high „laser on” or „laser off” DC level run a background cycle and Self-test again. If DC level values are still high do a flow cell cleaning, see section 10.3 1.4 from Service/Adjustments run „pressure offset adjustment” and check if values are within range; change the pressure sensor board (P/N: A5519) if „offset values cannot be adjusted”, message appears or if adjusted value is very close to the limit (refer to SM for limits) Next step is to bring the analyzer into the proper state where maintenance procedures can be performed without the risk of liquids spilling on parts. DO NOT skip the 3 procedures listed below: 1.5 from Service menu run „drain TCU” option; follow instructions in the SM regarding this procedure 1.6 from Service menu run „drain Flow cell” option; 1.7 from Maintenance menu empty all 3 chambers(RBC/PLT, WBC, MIX) At this point maintenance of parts can be started. Open the front cover and remove side covers of the analyzer. Inspect: 2. Valves 2.1 check for any dirt or deposit in the valve; if necessary clean inside of valve by pushing DI water or bleach through it by means of a syringe 2.2 if any sign show that liquid spilled on the valve, remove the valve head to see if liquid got also in the coil, if so, replace the coil 2.3 activate each valve from service menu; if switching of valve isn’t firm(smooth movement of membrane) try to clean it or replace the valve head 2.4 check the exhausting tube/vent nozzle on valve #5 to be free of dust or any deposit; clean it with DI water if necessary 2.5 special attention on valve #2: this valve and related tubing must be clean. In case of dirty valve/tubing, flow of laser waste through valve is restricted and it has direct influence on optical counts (!) Replace the valve and/or tubing if necessary 2.6 special attention on valves #34 and #35 as well; these valves and the related tubing must also be clean and free of any deposit. Replace the valve and/or tubing if necessary Proceed to step 3. 3. Tubes 3.1 all tubes must be clean inside; any deposit must be cleaned with bleach and rinsed with DI water or replace the tubing

132

Servicemanual 3.2 check tube connections on valves, chambers, SV, wash head, internal reservoirs etc. all connection points must be tight, otherwise change that tube portion with new tube 3.3 as a rule if a tube cannot be cleaned sufficiently and/or its’ connection isn’t tight it is recommended to be changed with new tube Proceed to step 4. 4. Chambers 4.1 all chambers must be clean, free of scratches or cracks 4.2 removal of chambers is recommended to check if no liquid has spilled behind them and also to see if the electrode is in good condition; change the chamber if any visible crack can be seen or if the electrode can be moved by hand 4.3 reinstall the chambers Proceed to step 5. 5. Dilutors 5.1 from service menu move dilutors one-by-one and check if large air bubbles are visible in the syringes or if any leakage sign can be seen on or beneath them; mark the syringe(s) where you saw large air bubbles getting in near the plunger 5.2 perform dilutor pistons cleaning and greasing procedure - Follow instructions of section 10.2; Black pistons should NOT be greased (!) Use a forceps to close the tube above the syringe you are going to remove. This is to avoid reagent from internal reservoirs spilling back to the reagent bottle. Remove one syringe at a time only! 5.3 cycle dilutors from service menu again, if any of the syringes does not seal properly (air bubbles are still getting inside near the plunger) replace the syringe(s) Analyticon recommendation as preventive maintenance: replace syringes after 50.000 measurement cycles 5.4 clean dilutor optosensors from dust by means of compressed air 5.5 clean the driving pin of dilutors then lubricate them with teflon grease Proceed to step 6. 6. Shear Valve 6.1 inspect tubes on SV for any deposit or discoloration, especially the „4diff waste” and „Laser in”(refer to fluidic schematic of the analyzer to identify these tubes) tube ; lower section of laser waste tube might have black color – it can be cleaned with bleach or that tube section can be changed. Note: when removing tubes from the SV ports use a small flat screwdriver to help the tube slide off from the port; to avoid misconnection remove only 1 tube at a time 6.2 check tightness of tubes on SV ports by hand, all tubes connections must be firm; if any tube comes off easily if pulled by hand that tube section should be changed 6.3 clean the SV optosensors from dust by means of compressed air 6.4 from service menu cycle the SV several times; if the movement isn’t smooth or noise is coming from driving mechanism, remove the cover behind the SV and lubricate the

133

Hemolyzer 5 cogged wheel/bar with machine grease; apply a thin film of teflon grease to the two ends of the sliding clutch-bed 6.5 reinstall the driving mechanism cover 6.6 change the blood sensor tube(tube between the needle and SV) Proceed to step 7. 7. Laser head The laser head doesn’t need to be opened for regular maintenance. Opening the laser head will end the warranty period for the optical head! If „laser on” DC level was high during repeated Self-test cycles, it might be necessary to clean the Flow Cell manually. This should be done only if „laser on” DC level is still high after the software given “flow cell cleaning” procedure option was done. If „laser off” DC level is high that might indicate failure of a component of the laser head. Contact Analyticon Support Team ( [email protected] ) for further information and assistance.

If any deposit can be seen in the „laser in” tube or if „laser on” DC level was high during Self-test than do the following: 7.1 remove the thick, RED coded tygon tube(laser waste) from the tube organizer and connect a syringe to it 7.2 prepare at least 10ml of 1/1 bleach solution(1 part bleach, 1 part DI water) in a cup 7.3 remove the „Laser in” tube from the SV and immerse it into the bleach 7.4 gently pull the syringe until at least half of the bleach is aspirated or until the „Laser in” tube is clean 7.5 remove the „Laser in” tube from the bleach and pull ~ 20ml of air through it 7.6 reconnect the „Laser in” and „laser waste” tubes to their ports Proceed to step 8. 8. TCU The TCU unit is a key assembly and proper functioning of this part is vital for good performance of the analyzer. Therefore with the occasion of periodic maintenance the TCU unit must also be inspected by service engineer. Inspection is only possible if the TCU unit is removed from the instrument. Follow instructions of the SM for removal of the TCU. 8.1 clean the fan and heat sink of the TCU from dust with compressed air 8.2 remove the in-line mixer cover and check the 2 tygon tubes for any deposit 8.3 if necessary clean or replace* the 2 tubes with 1,8x4,0 mm tygon tubes cut to the same length * Tubes of the in-line mixer are the bottleneck for flow inside the TCU. Any deposit in these tubes will cause overpressure in the 4diff sample preparation circuit which in worst case will result in tubes being pushed off from valves and would cause liquid spills inside the analyzer. Natural ageing of tygon results in loss of elasticity and small decrease of diameter. Ageing is speeded up by the aggressive reagents (Lyse5P, Diff5P).

134

Servicemanual Analyticon recommendation as preventive maintenance: change the in-line mixer tubes once per year. 8.4 reassemble the TCU unit to its place, follow instructions of the SM Proceed to step 9. 9. Wash head and XY block 9.1 clean the sliding bars of the XY unit with a paper towel and apply a thin film of teflon grease on them 9.2 clean the optosensor on the XY opto board with compressed air 9.3 verify the metal ports of the wash head are not loose, replace the wash head if any of the ports can be moved by hand 9.4 verify the vertical movement of wash head neck inside of the XY block by lifting it up from the needle holder

Attention: Sharp needle! Risk of injury! Biohazard!

9.5 vertical movement of the wash head must be easy without any obstruction, clean the wash head neck if movement isn’t smooth 9.6 clean the bottom of wash head Proceed to step 10. 10. Verification/adjustments From service menu run: 10.1 „pneumatic initialization” 10.2 „fill flow cell” 10.3 „fill TCU” Run shutdown then switch on the analyzer. 10.4 run background counts until background values are within accepted limit; several background cycles might be necessary to achieve good values – this is normal behavior after tubes and subassemblies have been drained and refilled 10.5 run Self-test (both) and check that all parameters are within range 10.6 if DC level is still high contact Analyticon Support ([email protected]) for further assistance 10.7 from service menu perform wash head and needle position verification; adjust if necessary 10.8 adjust blood sensor default value(with blood sensor disabled) 10.9 calibrate the blood sensor 10.10 verify calibration with fresh control blood; calibrate the instrument if necessary 10.11 run human samples and check results 10.12 run repeatability test(at least 11 measurements from one fresh human blood with normal values) and check CV%-s are within specification for all parameters Preventive maintenance is done!

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Hemolyzer 5

10.3 Flow cell cleaning The optical measurement system of the Hemolyzer 5 is strictly vacuum-based. Please do not apply pressure to the flow cell! Tools needed: • • •

small flat screwdriver Syringe(10-15 ml or bigger) small cup with Hypoclean CC or filtered bleach(approx.. 10-20 ml)

Procedure: 1. Open and secure front panel. 2. Run “empty flow cell” function. 3. Remove the laser waste tube from the connector located on left side of inner front panel. This tube has red strip on it. Use a small flat screwdriver to help the tube come off from the metal port. 4. Connect the (empty) syringe to the tube.

5. Disconnect the sheath tube from the connector located on left side of inner front panel. This tube has green strip on it and it is smaller in diameter. Use the screwdriver to help removal.

136

Servicemanual 6. Pour Hypoclean CC or filtered bleach into a cup and place the end of the sheath tube in it.

7. Gently pull the syringe to make the bleach flow through the Flow Cell. You can increase cleaning efficiency if you let air bubbles in the sheath tube while pulling. 8. Remove the sheath tube from the bleach and pull some air through the FC. 9. Reconnect sheath tube to its connector.

137

Hemolyzer 5 10. Remove the laser sample tube from upper disc of SV. This is the thinnest tube. Use the small flat screwdriver to help removal from metal port.

11. Place the end of sample injector tube in bleach. Gently pull the syringe to clean the sample injector tube from the inside. 12. Remove the sample injector tube from bleach, pull some air with the syringe, wipe the end of the tube and reconnect it to its port on the SV. 13. Remove the syringe from the laser waste tube and connect the tube back to its connector. 14. Run “fill flow cell” function. 15. Check that background and sample results are acceptable.

138

Servicemanual

11 Removal and replacement procedures 11.1 Opening the instrument Both side covers of the instrument can be easily removed. This allows reaching of the fluidic system and the mechanical parts. Other parts of the analyzer can be reached by lifting up the front panel. Don’t forget to secure the front cover in the upper position after lifting, as it may fall down if unsecured! To take off the left cover: Loosen the four milled-edge screws in the front and on the back of the analyzer. Pull the cover to the left to take it off.

To take off the right cover: The procedure is the same as in the case of the

left

cover. Milled-edge

139

Hemolyzer 5

11.2 Shear Valve Assembly Shear Valve Assembly is located in middle of front side of Hemolyzer 5 behind the front cover. Main parts of Shear Valve Unit: •

Ceramic valve

•

Driver unit with a stepper motor

•

SV Opto sensor board

Ceramic Valve removal • • • • •

Drain SV and the tubes on it using Shear Valve cleaning function in the Maintenance screen Prepare a piece of absorbent paper to dry components if necessary Remove the thumb screw on the valve Remove the upper ceramic disc Remove the lower ceramic disc of the valve pulling it upward

Ceramic Valve install •

Put back lower ceramic disk

•

Make sure the fixing plates hold the disc in tight enough, prevent the lower disk rotating. Please realign the plates if it needs.

•

Install the upper ceramic disk, making sure the longer horizontal pin is between the two rods of the Shear Valve drive. So it can move the upper ceramic disk. The other rod must be able to move into opto sensors freely. Fix the Shear Valve with the thumb screw. Please do a Shear Valve Opto SNSR alignment if the right side pin hits one of the opto sensors.

•

Check the operation.

140

Servicemanual Shear Valve Opto Sensor board replacement •

• • • • • • • • •

•

Shear Valve opto sensors are mounted to the right side on Shear Valve Assembly with 3 screws in such a way the sensors can be set separately. remove screw behind the circular opening (through the hole) Watch out the plastic washers. Remove the screws behind the oval opening (through the opening) pull out the opto board and remove the 2 cables Install a new board. connect cables install big board (2 screws) use plastic washers install small board (1 screw) use plastic washers Make sure that the lower disc’s flat side is aligned, and secure. You should not be able to move (twist) the lower disc at all. Please do a SV alignment procedure 6.2.

Shear Valve Assembly removal • • • •

Disconnect cable J7510 from SV opto board Disconnect SV motor cable from PPB Remove four screws on the front of SV assembly Move the SV assembly out of the instrument

11.3 XY Unit XY unit contains the slides for Horizontal and Vertical movements, two stepper motors, XYR opto board, opto wheel, sample rotor, wash head holder, wash head and the sampling needle. With the exception of the sampling needle, wash head, wash head holder and MHori (stepper motor for horizontal movement), for proper servicing the XY unit needs to be removed. The procedure is the following: • • •

Turn off the analyzer. Lift and secure the front panel, then remove the right cover. If the analyzer is equipped with an Autoloader, disconnect and remove the Autoloader module.

Loosen the two sampling needle fixing screws and remove the needle.

141

Hemolyzer 5 •

Sampling needle is sharp and represents biohazard! Take extra care and wear gloves when servicing this part of the analyzer.

•

Remove the baluster. Its lower screw can be access from the bottom of analyzer.

•

Locate and unscrew the four screws from the bottom of the analyzer, which hold the Sample Rotor basis.

•

Unscrew the two (upper and lower) screws which hold the rear part of the XY unit. One screw is located above the MVert (the bigger stepper motor for vertical movement and cap piercing), the other one is located below the optowheel and sliding bar, near the same motor.

142

Servicemanual •

• •

Gently remove the wash head holder with the wash head, by twisting it clockwise and pulling it down until released. Disconnect electrical cables Remove the XY unit

Sampling needle fixing screws

Upper

MVert Washing head and washing head MHori

Sample Rotor basis (the screws are located on the bottom of the analyzer).

Lower

For mounting back the XY unit, follow the steps listed above in reverse order. Make sure to perform the Sampling Needle adjustment procedure after reinstallation.

143

Hemolyzer 5

11.4 Sample Rotor Sample rotor holds the sample tube and turns it inside the instrument for cap piercing. In order to provide its proper operation with XY unit, they are equipped together. Sample Rotor removal: • • • •

•

Remove XY unit with Sample Rotor as it is written in previous item Remove two screws from the front of XY unit that hold the Sample Rotor rods Separate the Sample Rotor Pull off the door. Please check rotor arm and the hole of lower door plate rod position when put back the door. Two end position switches can be removed and motor of unit are accessible.

144

Servicemanual

11.5 Dilutors Hemolyzer 5 has two separate main dilutor modules, located behind the front panel on the lower part of the front plate. Each modules is secured by four hex screws and has a flat cable connection to PPB1 respectively PPB2. The removal/replacement procedure is as follows: 1. 2. 3. 4.

Turn off the analyzer. Lift and secure the front panel. Remove the tubing from the syringes. Unscrew the four hex screws and put them in a safe place where you can find them later. 5. Gently pull the unit toward you until you can see the flat cable connector on the rear side of the dilutor optoboard. Disconnect the cable. 6. Now the dilutor module is released and available for maintenance or replacement. To remount the dilutor unit, follow the steps described above in reverse order.

11.5.1

Syringe replacement

•

Remove two thumb screws from the syringe holder bar and remove the holder bar from the top of the syringes.

•

Remove lower thumb screw from syringe piston rod.

•

Remove the syringe

Installing back a new syringe take care the direction of piston rod. The wider hole must be turned inside the system.

145

Hemolyzer 5

Correct

Incorrect

11.6 TCU Module The Temperature Control Unit is located below the Laser Head Assembly. It is connected to the Shear Valve and to the tube organizer via Tygon tubing. The internal electronics are connected to the power supply and to the LSDACQ board. In order to remove this unit, follow the steps below: -

turn off the analyzer If autoloader is installed, disconnect and remove the Autoloader module. drain the TCU module manually  disconnect the BLACK tube and connect a 10ml syringe  disconnect the GREEN tube and aspirate liquid from the TCU module using the syringe  disconnect the WHITE tube and connect a 10ml syringe  disconnect the RED tube and aspirate liquid from the TCU module using the syringe

-

remove the screw above the shear valve (securing the front of the TCU)

146

Servicemanual -

remove the 4 screws in the back of the analyzer securing the rear

-

open the assembly plate on the left side of the analyzer to have access to the TCU control board cables locate and disconnect the power cable of the TCU module disconnect the controlling cable coming from the LSDACQ board pull the TCU out towards the back of the analyzer

-

To reinstall: follow the procedure in reverse order

11.7 Valve block 3/2 valves

3/2 valves

Valves can be removed together in one assembly (valve, coil, board) or individually one by one. To remove the complete assembly just unscrew the 6 mounting screw and disconnect the driver cables on the back. A valve has two main parts: the valve unit and electromagnet coil.

3/2 valves

147

Hemolyzer 5 The tubes are connected to the valve pins. The coil is soldered to valve block board. A plate fixes the main parts together on the coil site.

Pull with pliers To remove individually you’ll need to use a plier to pull the valve fixing plate out at the back and after that it is possible to remove only the valve itself.

11.8 Pre-Amplifier Board Pre-Amplifier Board is located inner side of the fluidics panel, behind the Measuring Black. It is under a metal cover that fixed to the fluidics panel with two screws. See the picture.

11.9 Pump Assembly 1. Open the front cover. 2. Remove the left side cover by loosening the four fixing screws. 3. Loosen the two clamp-screws on the rear panel and open the side pneumatic board.

148

Servicemanual 4. Pull off the connected tubes from inner fittings of Waste output and pump inlet tubes from lower right side of flow Panel.

5. Pull off the connected cables (red-green-black) from the PPB boards. The pump 1 (outer one) power cable is connected to PBB1 (left board), the pump 2 (inner one) power cable is connected to PBB2 (right board). 6. Unscrew the screws at the top of the pump fixing bar and pull it up with the white plastic bar. 7. Lift off the pumps.

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Hemolyzer 5

11.10

Hardware Module

The whole removing procedure is easier by opening the front cover and with removed side covers. 1. Unscrew the five screws connected on the rear plate. 2. The assembly is positioned and pushed down inside by a spring sheet. Gently pull out the fixing plate until almost the whole module comes out. Be careful not to strain the power and data cables connected to other parts inside. 3. If you want to completely remove the module you have to disconnect all the power and data cables connected inside.

150

Servicemanual

11.11

Laser Head Assembly

To remove the Laser Head: Turn on the analyzer. 1. Press and hold the Menu icon until the on-screen keyboard pops up, then type in the service password. Service button appears on the main screen, click on it to enter the service menu, then click on Service Functions/Drain flow cell and wait until the process finish. 2. Turn off the analyzer (from rear start switch) 3. Open (lift up) and secure front cover. 4. Remove right side cover. 5. Unscrew the 4 holding screws of the top cover then remove it by lifting and sliding it backwards. 6. Locate the three tube connections of the Laser Head. #1 – laser sample tube; #2 – sheath tube; #3 – laser waste tube.

1 2

3

7. Gently remove the tubes from the metal ports. Use a small flat screwdriver to help sliding tubes off.

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Hemolyzer 5

8. CLOSE FRONT DOOR 9. Disconnect both cables from the optical head. Refer to picture 4 below. (#1 – autoalignment cable*; #2 – optosensor board cable; #3 – laserdriver board cable) Note: it is easier to disconnect the laserdriver board cable from the LSDACQ board. Units produced after 2013.06.doesn’t have auto alignment cable.

152

Servicemanual

3

1 2

! 10. Locate the four holding screws of the base-plate of the optical head. Refer to Picture 5.below. Use a 2,5 mm hex screwdriver to remove the screws. Take extra care of the washers. 11. Gently remove the optical head unit. To avoid damage of the sample injector needle and sheath inlets on the base of the flow cell please always place the laser head assembly on its’ side or upside-down. Do not ben tubes too much.

153

Hemolyzer 5 11.11.1

Reinstalling the Laser Head:

(Analyzer is turned off, right side and top covers removed, front door is CLOSED) 1. Connect laser driver board cable to laser head. 2. Place the Laser Head to its’ place. Guide tubes to exit towards the front. 3. Tighten the screws, make sure that ground cable is also in place and washers are installed. 3. Reconnect autoalignment* and optosensor cables. 4. LIFT UP AND SECURE FRONT COVER. 5. Reconnect tubes to the corresponding ports. 6. Turn on the analyzer; activate the service menu, then click on Service/Auto alignment. Check the values of “laser power” (4 diff and baso) on “Laser settings” field. Compare these values with the Auto alignment datasheet received with the new laser head. Enter new values from the datasheet (only necessary if those are different from the analyzer’s values) and click on Save values. Exit from service menu. 7. Click on Measure for background count, if necessary repeat background cycles until all values are in acceptable range. 8. Prepare a freshly opened D-Check3P NORMAL level control. Run “Scatter Calibration Procedure”.

11.12 Measuring Block •

Remove the left side cover by loosening the four fixing screws.

•

Measurement Block is located middle upper side of flow panel, above the valve blocks. It has WBC measuring chamber, RBC/PLT measuring chamber, Mix chamber and a drain buffer.

11.12.1 Aperture removal: WBC, 80µm and RBC/PLT, 70 µm apertures are behind metal front plate of measuring units mounted by four screws. Two long ones (upper left and lower right) fixes the metal plate to the measuring chamber, two short ones (upper right and lower left) fix the measuring chamber the back plate of the unit. See the picture.

154

Servicemanual

11.12.2 WBC aperture removal: •

Drain the chambers in maintenance menu.

•

Unscrew hex nut on the right site of front panel that fixes the black metal shield.

•

Remove the black shield.

•

Remove four screws from the unit.

•

Remove black grounding wire and the metal plate with two tube fittings.

•

Aperture can be removed. Be careful with the plastic parts, do not scratch them.

11.12.3 Measuring Chamber removal: •

After two short screws (upper right and lower left) and black grounding wire removal, the measuring unit can be taken out.

•

Pay attention: if long screws had been removed, their square nuts on the back of measuring chamber may be fallen out from the unit. See the picture.

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Hemolyzer 5

11.12.4 HGB head removal •

WBC measuring chamber must be removed, as it is written above.

•

Pull off the HGB head from pre-amplifier connector.

11.13

Display unit

Display unit is installed on to the front panel of Hemolyzer 5 with a metal mounting unit. The LED display is controlled directly by Hardware block, the touch screen is driven by a Touch Controller board. It is behind the display, under a metal cover.

156

Servicemanual Display removal: • • • • • • • •

Turn the system off Remove the front cover fixing arm and two hinges Disconnect the grounding cable Take off the front panel and put it on flat surface Remove the metal cover of Touch Controller board Disconnect the cables Remove the metal mounting plate by taking out four screws Remove the LED display from the metal plate

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Hemolyzer 5

11.14

Hemolyzer 5 Fluidics v2.1 - SV in Chamber Position

158

Servicemanual

11.15

Hemolyzer 5 Fluidics v2.1 - SV in Needle Position

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Hemolyzer 5

11.16 Tubings Preparing of tubings: =

(A556)

=

=

(A545)

(A546)

T0

10

2

V1/3

V12/3

3,5

3,5

V 13/2

2

3,5

2 V4/3

2 V8/3

2 V6/3

10

P

12

7

V15/1

MEA PUFFER

8

4

V12/ 2

T1

2,5 6

3,5

3 2 V3/3

4

22

2,5 2

2

16 V15/2

V9/1

V11/1

T4 WBC BASO

Cham Puffer

114

2

7

2

V29/1

SVF12

2 V11/2 T6

T5 V36/2

2

5 5

V23/2

40

V13/1

Washing head

2

2 V7/3

T3

V10/1

8

2 V5/3

T2

2,5

25

3,5

3,5

V12/1

V2/2

4

4

22

V17/3

3

V14/1

V26/2

V20/2

T7 Dilu I. puffer

4

47

SHEAT PUFFER

T8 9.

31 Dilu II. puffer

1,7

V32/2

160

6.

V16/1

Servicemanual DILU I. PUFFER

DILU II. PUFFER

2

2 2,5

V43/1

2,5

9,3

3

20

8

18,5

3 V41/1

T9

2

2

V42/1

V40/1

V36/1

10 V37/1

RBC

T10

MIX

2

2

V42/2

V29/2

40

40

9.

9.

V9/2

V10/2

MEA PUFFER

T12 V34/2

T13

2,5

2 MEA Puff Small

20

3

6.

T11

V35/2

V3/2

7

MEA PUFFER Dilu I. Puffer . Dilu II Puffer

T14 4

4

20

V8/2

MEA Puffer Small MEA Puffer Small

161

T15

10

10

23

V23/1

Hemolyzer 5 CK1 CL1

CL2

Cham Puffer

1

CL3

RBC

MIX

CF2 1

CL4

BASO

CF3

CF4

CA3

CA4

2

2

3

MEA PUFFER

C1

C2

C4

C3

3

1 1 V1

V2

V3

V12 V13

V12 V14

2

3

1

2 3

1

V4

2

3

1

2

1

1

1

V10

V11

V5

V6

V7

V8

V9

V12 V17

V12 V18

V19

V20

2

2

3

1

3

1

1

2

2

2

2

1

V12 V16 3

1

2

2

1

1

1

V12 V15

2

2

2

1 3

2

1

1

V12 V12 3

2

2

3

2

3 4

1 2

1

2

5

4 T6

6 7

T6

5

8

5

T6

2

1

3

2

T6

1 V23 V34

1 3

2

1

V24

V25

V26

V35

V12 V36

VV37 12

1

1 2

3

2

2 1

3

1

3

2

2

V12 V38 2

3

1

2 1

V29

V30

V12 V40

V12 V41

3

2 1

T12

3

3

2

3

1

2

1 3

2

V12 V42 2

3

1

2

V32

V33

VV43 12

VV44 12

3

1

1 3

2

1

2 1

3

34

3

3

3

V28

40

40 3 34

3

9 10 11

2 1

12 13 14

4

15

3

16 17 18 19

Sheath Puffer

Lyse Puffer

Dilu I. Puffer

Dilu II. Puffer

1

1

1

1

1

1 2

Stop Puffer

2

2

2

2

40

34 40

162

2

34

Mea Puffer Small

40

4

1 2

V12 V39

T6 T12

3

Servicemanual CK1

= Kicsi CL1

CL2

CL3

CL4

= Nagy

Cham Puffer

1

RBC

MIX

BASO

CF2 1

CF3

CF4

CA3

CA4

2

2 MEA PUFFER

3 C2

C3

C4

T3

19 cm

3

T3

T2

C1

T2

T3

V1

V3 V12 V14

2

2

3

1

3

1

V4 V12 V15

2

3

1

T2

T2

1

V5

V6 V12 V17

3

1

2

1

V10

V11

V8

V9

V19

V20

3

1

2

2

2

1

V7

1

2

1

V12 V18

2

3

1

2

2 1

1

V12 V16 2

2

2

1

T3

3

V2 V12 V13

2

1 3

2

1

1

V12 V12

1

2

2

3

T3

T2

T2 1 2

T2

T2

T3

3 4

1 2

1

2

5

4

3

1 3

2

V24

V25

V35

V12 V36

1

1 2

3

2

1

1

3

2

2

V26

1

3

3

3

1

2 1

3

40

1

T12

T12

2

3

3

3

2

1 3

2 V30

3

1

2

3

1

2

V32

V33

2

3

1

2

11 40 34 3

3

1

3

9 10 11

VV44 12

VV43 12

V12 V42

V12 V41 2

8

1 3

1

2 1

12 13 14

4

15

3

16 17 18 19

Sheath Puffer

Lyse Puffer

Dilu I. Puffer

Dilu II. Puffer

1

1

1

1

1

1 2

Stop Puffer

2

2

2

2

40

34 40

163

2

34

Mea Puffer Small

40

4

3

5

34

T6

3

V12 V40

V12 V39

V12 V38 2

1 2 V29

V28

VV37 12 2

5 5

T6 T2

3 8

T2 T6

V34

T3

11

1 2

T2

2 1

T2

7

16 cm T6

V23

6

T6

T2

Hemolyzer 5 12

CK1 CL1

12

1

CL2

Cham Puffer

CL3

RBC

MIX

CF2 1

12

2

BASO

CF3

CF4

CA3

CA4

2

19

33

3

MEA PUFFER

CL4

C2

C3

C4

T3

T3

T2

C1

T2

3

T3 T2

T2

T3

T2

T2

28

T2

33

T2

T3

19

1

V1

V3 V12 V14

2

2

3

1

3

1

V4 V12 V15

2

3

1

2

1

V5

V6 V12 V17

2

V7

V8

V12 V18

V19

2

3

1

3

1

2

2 1

1

V12 V16 3

1

2

2

1

T3

V2 V12 V13

2

1 3

2

1

1

V12 V12 3

2

2

3

19

1 2

2

2

1

1

V9

V10

V11

3

V20

1

2

2

1

4

1 2

1

2

5

4

6 19

7

3

T6

V23 V34

1 3

2

1

V24

V25

V26

V35

V12 V36

VV37 12

1

1 2

3

2

1

3

5 2

V12 V38 2

3

1

2 1

V29

V30 V12 V41

3

2 1

3

2

3

1

2

1 3

2

V12 V40

T12

3

3

5

V12 V42 2

3

1

2

V32

V33

VV43 12

VV44 12

3

1

2

3

1

3

11 40 34 3

8

1 3

2

1

34

3

3

1 2

V28

T6

T12

3

V12 V39

40

28

2

1

3

2

19 5

11

1 2

T2

28 33 2 1

T3

T6 T2

T6

4

T2

T2

40

3 8

T6

T2

9 10 11

2 1

12 13 14

4

15

3

40

16 17 18

Lyse Puffer

Dilu I. Puffer

Dilu II. Puffer

1

1

1

1

1

1 2

Stop Puffer

2

2

2 40

40

2

34 40

164

2

40

19

Sheath Puffer

34

Mea Puffer Small

Servicemanual 12 CK1

CL1 12

Cham Puffer

1

CL4

RBC

MIX

BASO

CF3

CF4

CA3

CA4

12

2

C2

C3

42

C4

T3

3

36

2

3

1

3

1

V4 V12 V15

2

3

1

1

2

V5

V6 V12 V17

2

V7

V8

V12 V18

V19

2

3

1

3

1

2

2 1

1

V12 V16 3

1

1

19

V3 V12 V14

T3

2

2

1

T3

V2 V12 V13

2

T2

T2

T2 V1

2

1 3

2

1

1

V12 V12 3

2

2

3

T3 T2

T2

28

T3

19

1 2

T2

42 T2

33

T3

T2

C1

19

3

36

33

MEA PUFFER

CL3

CF2

1 2

CL2

2

2

1

1

V9

V10

V11

3

V20

1

2

2

1

1 2

1

A5433

2

4

1 2

3

2

1

2

3

1

14

1

2 1

14

T12

T12

3

4

3

3

3

3

2

1 3

2 V30

2

3

1

2

3

1

2

V32

V33

1

3

11

9 10 11

VV44 12 2

14

40 3 34

3

2

3

1

8

1 3

1

VV43 12

V12 V42

V12 V41

V12 V40

V12 V39 2

3

V29

V28 V12 V38

1 2

5

34

T6

3

3

2

V26 VV37 12

2

1

3

40

28

2

14

1

V25 V12 V36

V35

V34

17

T6

V24

1

1 3

2

19 5

11

V23

14

3

14

HF STOP 2 (20)

5

T2

28

1 2

7

T3

T6 T2

33 2

T2 T2

14

T6

1

19

3 8

40

5 6

T6

42 36

T2

4

2 1

12 13 14

4

3

15

40

16 17 18

Lyse Puffer

Dilu I. Puffer

Dilu II. Puffer

1

1

1

1

1

1 2

Stop Puffer

2 40

40

2

2

2

34 40

165

2

40

19

Sheath Puffer

34

Mea Puffer Small

Hemolyzer 5 12

CK1

12

Cham Puffer

1 1

RBC

MIX

BASO

CF2

CF3

CF4

CA3

CA4

C2

C3

C4

T3

3

T2

36 T2 V3 V12 V14

2

2

3

1

3

1

V4 V12 V15

2

3

1

2

T2

T2

T2

V5

V6 V12 V17

2

V7

V8

V12 V18

V19

2

3

1

3

1

2

2 1

1

V12 V16 3

1

1

T3

V2 VV13 12

2

2

1

19

V1

2

1 3

2

1

1

V12 V12 3

2

2

3

1

19

1 2

T3

T2

28

T3

T3

42

T2

33

T3

T2

C1

42

3

19

36

33

MEA PUFFER

CL4

12

2

2

CL3

CL2

CL1

2

2

1

1

V9

V10

V11

3

V20

1

2

2

1

4

1 2

1

A5433

2

4

T6

V24

1

V25

1 2

3

2

2 1

2

V12 V38 3

1

2

14

T15

4

3

3

3

V29

V30

V12 V40

V12 V41

3

2 1

3

2

3

1

5

HF LYSE 2 (20)

2

1 3

2

V28

14 3

1 2

V12 V39

V32

2

3

1

2

3

1

14

14

40 34 3

3

11

VV44 12 2 1

3

11

9 10

V33

VV43 12

V12 V42

8

1 3

2

1

2 1

12 13

14

T12

T12

1

3

34

T6

3

2

40

28

V26 VV37 12

V12 V36

V35

1

3

2

14

V23 V34

1

1 3

2

14

3

19 5

14

5 1 2

17

2 1

6

HF STOP 2 (20)

11

33

14

5

7

T3

T6 T2

5

12

T2

14

T6

14

T2 T2

28

15

19

3 8

40

2

T6

42 36

T2

14

14

4

15

3

40

16 17 18

T15

1

1 2

1

2

40

2

40

T15

Stop Puffer

Lyse Puffer

Dilu I. Puffer

Dilu II. Puffer

1

1

1 2

2

34 40

166

2

40

19

Sheath Puffer

34

Mea Puffer Small

Servicemanual

1 2 3 4 5 6 7 8 9 10 11 12

38

13

37

37

37 35

14

35 35

15

17

16 L

17 18 19

167

Lyse - EO

L D

D

L y se - EO

D

D

Hemolyzer 5 1 2 3 4 5 6 7 1

2

3

1

1

2

V2 3

V24

V2 5

V3 5

VV36 12

V 34 1

1 2

2

2

3

3

1 2

3

1 2

VV12 37

1

3

2 V29

2 1

3

1

3

2 V2 8

1

2

1

1

3

2

V30

3

1

3

2

3

V3 1

VV41 12 2

2 3

1

3

V1 V420

VV39 12

VV38 12 2

2

1

3

V27

V26

1

3

2 V33

VV12 43

VV12 42 2

1

1 V3 2

2 1

3

1

38

37

37

37

35

35

35

17

35

9 10

2 1

12 13 14

37

35

3

11

37

37

8

VV4 124 2

38

35

3

15 16 17 18 19

168

Servicemanual

169

Hemolyzer 5

Note: 400cm tube from V20 to SV upper disc is type A5433 1.27/2.23

170

Servicemanual

12

Appendix

12.1 Recommended kit of tools •

PC standard keyboard (USB)

•

Screwdrivers: Slot Screwdrivers Cross Slot Screwdrivers (Philips) Hexagon Screwdrivers (3.5, 2.5, 2.0, 1.5 mm sizes)

•

Pocket digital multimeter

•

Diagonal Cutter (plier)

•

Nipper

12.2 How to send .rp files to assessment of analyzer performance Insert a pendrive (USB stick) in one of the USB ports. From ’Database’ press ’multiselect’ then select the results you want to save( It is very important to save some human blood measurement results not just controls), then press ’manage records’. A window will appear, press ’export’. The analyzer will search for the pendrive, usually it will be displayed as drive E:. Double click on the folder icon (just like in windows), the content of the pendrive will appear. Press ’OK’. rp files will be saved. You can send these files on to Support for investigation of analyzer performance.

171

Hemolyzer 5

12.3 How to use the „Collect” function of the Hemolyzer 5 hematology analyzer When is it needed? -

After servicing the analyzer (for documentation purposes) When requested by the service engineer (user can do it) When requested by Analyticon Support

How to do it? -

Run a blank measurement* Run a patient sample* Run a control measurement* From ’Menu/Diagnostics/Self-test’ click on ’Start both’ button and wait for the result. Insert a USB Stick in one of the USB ports on back of the analyzer From ’Diagnostics/Information’ click on ’Refresh data’ then on ’Collect’ button. When the window with drive E:/ appears select the drive then click on ’OK’ button This function saves the following information in a .gz file: o Self-test result o Stress Blank result o Last 10 Human measurement rp-file o Last 3 Control measurement rp-file o Last Blank measurement rp-file o Event log o Statistics o User/Service/calibration factors o SW – PIC – Firmware versions

Keep the file for your records or send it to [email protected] if asked by support staff. * Not mandatory

end of document

172