DIATRON MI Zrt.

H-1097 Budapest, Táblás u. 39 Hungary

Phone: +36 1 436 9800 Fax: +36 1 436 9809
www.diatron.com

VUM094
Revision history

Rev. Author Sections affected Effective Date

2.5 Dimitris All sections affected. Initial version for Rayo software 2.5.1 2018.06.01
Giantzoudis,
Lilla Erdei,
Bartosz Kozera

DO NOT PRINT THIS

PAGE!

APPROVALS
Role Name Signature Date
Project manager Barna Reskó

Quality Assurance Gábor Nagy

Marketing Andrea Kocsis

Author Bartosz Kozera

P500 v2.5 1
DIATRON MI Zrt.
H-1097 Budapest, Táblás u. 39 Hungary
Phone: +36 1 436 9800 Fax: +36 1 436 9809
www.diatron.com

Printing/typographic specifications

Paper size A4
Color / Grayscale Color
Single / double sided Double sided
Paper quality Normal white paper 80g
Paper binding Comb binding, including a translucent front cover page and white back
cover.
Other Printing range: 3 (front-page ) to 160

DO NOT PRINT THIS

PAGE!

P500 v2.5 2
DIATRON MI Zrt.
H-1097 Budapest, Táblás u. 39 Hungary
Phone: +36 1 436 9800 Fax: +36 1 436 9809
www.diatron.com

P500-1 – Pictus 500 Clinical

chemistry analyser

P500-2 – Pictus 500 Clinical

chemistry analyser with ISE
Medica module

INSTALLATION AND
USER'S MANUAL

P500 v2.5 3
DIATRON MI Zrt.
H-1097 Budapest, Táblás u. 39 Hungary
Phone: +36 1 436 9800 Fax: +36 1 436 9809
www.diatron.com

1 USE 10

2 WARNINGS AND PRECAUTIONS 11

3 INTRODUCTION 17

3.1 MAIN COMPONENTS AND VIEWS 18

3.1.1 SAMPLES & SAMPLE SECTORS 20
3.1.2 REAGENTS 21
3.1.3 CUVETTES 22
3.2 SOFTWARE FUNCTIONS OVERVIEW 22
3.2.1 LEVELS OF ACCESS 22
3.2.2 OTHER FUNCTIONS INCLUDED IN DATA MENU. 24
3.2.3 MAIN SCREEN 25
3.2.4 RELEVANT SCREENS 28

4 INSTALLATION 31

4.1 UNPACKING 31
4.2 INSTRUMENT SET UP 32
4.2.1 INSTALLATION REQUIREMENTS. 32
4.2.2 ELECTRICAL CONNECTIONS 34
4.2.3 HYDRAULICS 34
4.2.4 HANDLING OF BIOLOGICAL FLUIDS 35
4.3 COMPUTER SETUP 35
4.4 PARAMETERS 37
4.4.1 SOFTWARE 37
4.4.2 USE 42
4.4.3 REPORTS 42
4.4.4 SECTOR DEFINITION 43
4.4.5 DEBUG 43
4.5 TOOLS 44
4.5.1 TRANSLATOR 44
4.5.2 MODIFY REPORTS 45

5 GET READY FOR OPERATION 47

5.1 AUTOMATIC OPERATION 47

5.1.1 CLOT DETECTOR 48

6 ROUTINE TASKS 49

6.1 REACTION TRAYS 49

6.1.1 CHANGING REACTION CUVETTES 49
6.2 REAGENTS 49
6.2.1 REAGENT TRAY 49
6.2.2 LOADING BAR-CODED REAGENTS 50
6.2.3 LOADING NON BAR-CODED REAGENTS AND SOLUTIONS 51

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H-1097 Budapest, Táblás u. 39 Hungary
Phone: +36 1 436 9800 Fax: +36 1 436 9809
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6.2.4 REMOVING REAGENTS AND SOLUTIONS 53

6.2.5 RE-FILLING REAGENT BOTTLES 54
6.3 SAMPLES 55
6.3.1 WORKING WITH PATIENTS 55
6.3.2 DEFINING SAMPLE DATA AND TESTS 56
6.3.3 REMOVING A SAMPLE 58
6.3.4 REMOVING TESTS 59
6.3.5 COPY DATA 59
6.3.6 LOADING SAMPLES 59
6.3.7 LOADING BAR-CODED SAMPLES 60
6.3.8 LOADING NON BAR-CODED SAMPLES, CALIBRATORS AND CONTROLS 60
6.3.9 REMOVING A SAMPLE 61
6.3.10 PLACING A SECTOR ON THE TRAY 61
6.3.11 REMOVING A SECTOR 62
6.3.12 LOADING A STAT 62
6.3.13 REPORTS ON LOAD AND USE 62
6.4 TEST RESULTS 64
6.4.1 ACCEPTANCE OF RESULTS 65
6.4.2 REFLEX TESTS 65
6.4.3 PRINTOUT OF RESULTS 65
6.4.4 CUVETTE REPORT 66
6.5 CALIBRATION 66
6.5.1 CALIBRATOR SETS 67
6.5.2 DEFINING A CALIBRATOR SET 67
6.5.3 REMOVING A CALIBRATOR SET 68
6.5.4 AUTOMATIC DILUTIONS 68
6.5.5 REQUESTING A CALIBRATION 69
6.5.6 ORDERING A CALIBRATION 70
6.5.7 CALIBRATION ACCEPTANCE 70
6.5.8 FLAGGED RESULTS 70
6.5.9 CALCULATIONS 70
6.5.10 AUTOMATIC CALIBRATION 71
6.6 BLANKS 72
6.7 QUALITY CONTROL 73
6.7.1 CREATING A CONTROL SET 73
6.7.2 REQUESTING A CONTROL 74
6.7.3 PROCESSING A CONTROL 75
6.7.4 PROCESSED CONTROLS. STATISTICS 76
6.7.5 TWIN QC 77
6.7.6 QC SCHEDULER 78
6.8 WORKING WITH LIS 79
6.8.1 PARAMETERS 79
6.9 DEFINITION AND USE OF SAMPLE PROFILES 80
6.9.1 DEFINING A SAMPLE PROFILE 80
6.9.2 REMOVING A SAMPLE PROFILE 81

7 DEFINITION OF METHODS 82

7.1 MANAGEMENT 82
7.1.1 CREATING OR EDITING A METHOD 83
7.1.2 ERASING A METHOD 83

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H-1097 Budapest, Táblás u. 39 Hungary
Phone: +36 1 436 9800 Fax: +36 1 436 9809
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7.2 METHOD PARAMETERS 83

7.2.1 COMMON PARAMETERS 83
7.2.2 MAIN PAGE 84
7.2.3 SPECIFIC DATA. 85
7.2.4 QUANTITATIVE 85
7.2.5 LIMITS 86
7.2.6 REFERENCE CLASSES 87
7.2.7 ADVANCED FEATURES 87
7.2.8 CONSUMPTION 88
7.2.9 REAGENT SUBSTITUTION 89
7.3 COAGULATION METHODS 89
7.3.1 MAIN PAGE 90
7.4 SOLUTIONS AND OPTIONS 91
7.5 CALCULATED METHODS. 92
7.6 EXTERNAL METHODS 93
7.7 UNITS AND LIMITS. 94
7.8 UNITS CONVERSION 95
7.9 DEVELOPMENT OF A METHOD 96

8 ISE MODULE 97

8.1 ISE MEDICA MODULE 97

8.1.1 OVERVIEW 97
8.1.2 ELECTRODES 98
8.1.3 FLUID MANAGEMENT 99
8.1.4 CALIBRANT A 99
8.1.5 CALIBRANT B 100
8.1.6 CLEANING SOLUTION 100
8.1.7 MEDICA URINE DILUENT. 100
8.1.8 TEST RANGES 101
8.1.9 ISE PACK INSTALLATION 102
8.1.10 ISE PACK REMOVAL 104
8.1.11 MEDICA OPERATIONAL PARAMETERS 104
8.1.12 MAINTENANCE 105
8.1.13 PREPARING THE ISE MODULE FOR STORAGE 105
8.1.14 TROUBLESHOOTING 107
8.2 METHODS 112
8.3 OPERATION 112
8.3.1 MAINTENANCE OPERATION 112
8.3.2 AUTOMATIC OPERATION 113

9 MAINTENANCE 114

9.1 COUNTERS 114

9.2 SCHEDULER 115
9.2.1 SCHEDULE 116
9.2.2 STATUS 117
9.3 DAILY QC 119
9.4 DAILY CARE AND MAINTENANCE 119
9.4.1 ISE PRIMING SERUM 119

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H-1097 Budapest, Táblás u. 39 Hungary
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9.4.2 INSPECTION AND CLEANING OF PROBE 119

9.4.3 HYDRAULIC TESTING 120
9.4.4 REPLACEMENT OF WASH SOLUTION AND EMPTY WASTE 120
9.4.5 CUVETTE WATER BLANK 121
9.4.6 INTENSIVE WASHER CLEANING 121
9.5 WEEKLY MAINTENANCE ROUTINE 121
9.5.1 INTENSIVE CUVETTE CLEANING 121
9.5.2 CHANGE SOLUTIONS 122
9.5.3 SERVICE BACKUP 122
9.6 MONTHLY MAINTENANCE RECOMMENDATIONS 122
9.6.1 WASHER VOLUME CALIBRATION 123
9.6.2 INTENSIVE WASHER CLEANING 123
9.6.3 OTHER TASKS 123
9.7 MAINTENANCE ON DEMAND 124
9.8 SUMMARY OF MAINTENANCE ACTIVITIES 125
9.9 MAINTENANCE ON DEMAND 126
9.10 LAMP REPLACEMENT 126
9.11 PUMP TUBE REPLACEMENT 126
9.12 DRYER BLOCK REPLACEMENT 127
9.13 SYRINGE REPLACEMENT 128
9.14 LONG TERM SHUTDOWN PROCEDURE 129

10 TROUBLESHOOTING 130

10.1 MESSAGES AND WARNINGS 130

10.2 VISIBLE FAULTS 131
10.2.1 GENERAL FAULTS 131
10.2.2 AUTOMATIC CUVETTE WASHER MALFUNCTIONING. 133
10.3 MEASUREMENT INCONSISTENCIES 133

11 SYSTEM TESTS 137

11.1 TEMPERATURE 137

11.2 STRAY LIGHT 137
11.3 NOISE 138
11.4 STABILITY 138
11.5 TIP PUMP 138
11.6 LEVEL DETECTION 138
11.7 WASHER HYDRAULICS 139
11.8 WASHER 140
11.9 DILUTION 140
11.10 PHOTOMETER LINEARITY 140
11.11 DILUTER LINEARITY 140
11.12 LEVEL DETECTION 141
11.13 CHEMISTRY ANALYSIS 141
11.14 CLOT DETECTOR 141

12 BACKGROUND 142

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H-1097 Budapest, Táblás u. 39 Hungary
Phone: +36 1 436 9800 Fax: +36 1 436 9809
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12.1 METHODS TYPES AND CALCULATIONS 142

12.1.1 SINGLE POINT END POINT 142
12.1.2 TWO POINT END POINT 142
12.1.3 FIXED POINT 143
12.1.4 KINETICS 144

13 TECHNICAL SPECIFICATIONS 145

14 CALIBRATION 146

14.1 MECHANICAL CALIBRATION 146

14.1.1 PHOTOMETER 146
14.1.2 ARM AND REACTION TRAY 147
14.1.3 WASHER 148
14.1.4 ARM AND WASHING STATION 148
14.1.5 ARM AND SAMPLE TRAY 149
14.1.6 ARM AND REAGENT TRAY 150
14.1.7 SAMPLE TRAY 151
14.1.8 REAGENT TRAY 151
14.1.9 BAR CODE READER 151
14.1.10 ISE MODULE 152
14.2 PHOTOMETER CALIBRATION 153
14.3 REAGENT BOTTLES 153

15 BARCODE READER 154

15.1 DEFINITIONS 154

15.2 USAGE OF BARCODE FEATURES 154
15.3 PARAMETERS FOR BARCODE READER 154
15.4 IMPLEMENTATION OF BARCODES 156

16 SERVICE OPTIONS 157

16.1 LAMP INTENSITY 157

16.2 FILTER WHEEL 157
16.3 OTHER SERVICING OPTIONS 158
16.3.1 MANUAL 158
16.3.2 COMMUNICATION 158
16.3.3 DEBUG 159
16.3.4 PARAMETERS 159

P500 v2.5 8
DIATRON MI Zrt.
H-1097 Budapest, Táblás u. 39 Hungary
Phone: +36 1 436 9800 Fax: +36 1 436 9809
www.diatron.com

Conventions Used In This Manual

Software buttons: Edit

Software list options and menus: Place Reagent

Keyboard keys: Enter

P500 v2.5.1 9
DIATRON MI Zrt.
H-1097 Budapest, Táblás u. 39 Hungary
Phone: +36 1 436 9800 Fax: +36 1 436 9809
www.diatron.com

1 Use
Although the Diatron MI Plc. analyzer system uses high performance components, which
provide a high degree of safety, it is essential that the user takes the usual precautions to
safeguard himself and to ensure a safe working environment.

Diatron MI Plc. only guarantees the workmanship and materials of its products. It is the
duty of the user to take care of safe operation and no amount of warnings can take place
of such care.

As regards the moving parts in the analyzer, these have been appropriately protected to
avoid any potential risks to the user, and for proper instrument operation and safety.
However, it is highly recommended to exercise extreme care during analyzer operation
and especially when working close to the devices.

To avoid accidental contamination, use suitable guards and/or personal protection, such
as overall and gloves. When handling reagents, it is advisable to observe good laboratory
practice (GLP) rules.

Chemicals, serum samples and reagents must be handled with extreme caution. Patient
samples may be biologically hazardous. The reagents or any other substances that may
enter in contact with samples should be treated in the same way as samples themselves.

The materials of human origin, such as control sera, must be considered as potentially
infective and thus must be handled with extreme caution. The reagents and any other
substance entering in contact with samples must be treated in the same way. The
reagents must be manipulated (before, during and after the use) by qualified personnel
familiar with their characteristics in order to safeguard the user as well as the quality of
the reagent itself.

P500 v2.5.1 10
DIATRON MI Zrt.
H-1097 Budapest, Táblás u. 39 Hungary
Phone: +36 1 436 9800 Fax: +36 1 436 9809
www.diatron.com

2 Warnings and precautions

The following warnings will aid the user to provide adequate safeguards to assure safe
trouble-free performance:
NOTE:
The analyzer system must not be dismantled or repaired by anyone who has not
been qualified by the manufacturer. Incorrect work may cause fire or irreparable
damage to the system.

1. Before operating this system, be sure to read the operator manual thoroughly and
carefully. Afterwards, keep it handy for future reference.

2. Take special care to follow the warnings and cautions indicated on the system rear
panel as well as in the operator manual.

3. System’s use should be restricted to lab’s qualified personnel only. The instrument only
can be used by trained operators. Always follow the instructions and pay attention to
the warning labels

4. Under no circumstances is this instrument case to be opened. This instrument is not

user serviceable. Dangerous high voltages inside this instrument case. In event of
difficulty, please notify your dealer for prompt service.

5. For operating safety, do not install the system in a location where it will be exposed to
heating equipment or radiators, direct sun light, or any other source of extremely high
temperatures.

6. Do not operate the system in the presence of flammable fluids or gaseous atmosphere,
disinfecting agents, cleaning agents, etc., due to possible fire or explosion.

7. Do not kink, bend, lay object on, or otherwise damage or restrict cables and tubes.

8. Be sure that the main power switch on the back panel of system is off when plugging
in, or removing the power corset from a wall outlet.

9. Turn off the mains power switch on the rear panel whenever the system is not in use.
This prevents damages due to surge in the mains power.

10. Do not attempt to alter the shape of any part of the system.

11. If the system is not operating properly and the trouble-shooting section does not provide
a satisfactory solution to the problem, then do not use the system until the defects are
remedied.

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DIATRON MI Zrt.
H-1097 Budapest, Táblás u. 39 Hungary
Phone: +36 1 436 9800 Fax: +36 1 436 9809
www.diatron.com

12. Inspect all accessories and system cords. Do not use if damage can be seen such as
cut insulation or outer covering, frayed or broken wires, corroded or broken connectors
etc.

13. Only connect instrument to a line complying with local or national rules and
specifications.

14. To reduce the risk of fire or electric shock, do not allow fluids or any foreign object to
enter the system. Wipe off spills immediately.

15. Do not use benzene, thinner, and any kind of solvents, or abrasive detergents to clean
the case. Clean with soft dusting cloth dampened with distilled water. If necessary use
only neutral detergent.

16. Do not stick objects of any kind into the system through back panel or case slots as
they may touch dangerous voltage points or short out parts that could result in fire or
electric shock.

17. Install the system in such a way that adequate ventilation is provided all around to
properly dissipate the heat.

18. Make sure all fluid lines are free of kinks, nicks, sharp bends, punctures, loops or
occlusions before installing on system.

19. Do not overload accessories power outlets and extension cords as this can result in fire
or electric shock.

20. Do not place the system on an unstable cart, stand, or table; the system may fall,
causing serious injury to user, and serious damage to the appliance. Place the system
on a stable, vibration-free, level table or cart.

21. Use only secure power source to protect the analyzer system against power surges.
Disconnect temporarily the analyzer power cord from the wall outlet in case of bad
atmospheric conditions.

22. Empty waste container whenever it is full. Ensure that the container lids are screwed
on tightly to prevent leakage or dispersion into the environment.

23. The safe disposal of the analyzer waste material with minimal environmental impact is
the responsibility of the user and will have to meet the local laws and dispositions.

24. Do not attempt to remove any panels or coverings of the analyzer system while the
system is in operation.

25. After operation/servicing, cover the system with a protective plastic or cloth sheet.

P500 v2.5.1 12
DIATRON MI Zrt.
H-1097 Budapest, Táblás u. 39 Hungary
Phone: +36 1 436 9800 Fax: +36 1 436 9809
www.diatron.com

26. Be particularly cautious that no parts of your body (e.g. fingers hair, etc.) or loose
objects (e.g. cables, tubing, etc.) can be trapped by any moving or rotating parts (e.g.
sampling arm, plates, washer module, pump rollers etc.) of the analyzer system.

27. Never use instrument for a purpose other than specified by manufacturer (for purpose
description, see Chapter 1). 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. The accuracy and precision may also be impaired.

28. The computer and its accessories for operation of the instrument are of exclusive use.
The installation of other programs and or nets, is strictly forbidden and can affect the
warranty conditions. LIS program should be installed in a different computer.

29. Do not switch on instrument on within 20 seconds of turning it off.

30. Peripherals and external devices:

31. As a general rule: if any peripheral device you wish to connect has its own power source
/ power supply, switch off both the peripheral device and the ‘Pictus 500’ instrument
before connecting the peripheral device.

32. The peripheral connectors on the ‘Pictus 500’ are SELV (safety extra low voltage)
connectors, only connect external devices that are approved SELV rated to the
instrument to avoid the risk of electrical shock.

33. Do not connect monitors, printers or unauthorized cables in the USB output of
instrument.

34. Keep all covers closed and in place while the instrument is operating.

35. Follows Software instructions to replace samples, reagents and reaction cuvettes.

36. Do not attempt to change samples, reagents or reaction cuvettes if ALARM LEDs are
RED.

37. Do not touch any parts of the instrument other than those specified. During operation
and maintenance of the instrument, proceed according to the instructions.

38. Do not tamper any cover sensor.

39. To change lamps and other elements, follow directions included in the user manual.

40. The use of most screen savers can affect communication between PC and
Autoanalyzer. Use only “Bezier” at its minimum speed, if a screen saver must be
utilized. Do not use options on stopping the hard disks.

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DIATRON MI Zrt.
H-1097 Budapest, Táblás u. 39 Hungary
Phone: +36 1 436 9800 Fax: +36 1 436 9809
www.diatron.com

41. When the system is in operation please keep the main cover down to improve
performance of the instrument.

42. After maintenance or service procedure it’s mandatory for the user to check the service
report where the trained service representative ensures that the instrument’s safety
level is not decreased.

43. Based on the performed risk analysis it’s quaranteed that the trained user doesn’t need
further operator action in case of residual risk as long as the operator works according
to the user manual and takes care of the warning labels.

44. Never dispose potentially dangerous fluids in a public drainage system, always follow
the local national regulations.

45. Regarding the used P500 instrument and P500 disposable materials (cuvettes,tubes,
reagent bottles) handling always follow the local national regulations.

For technical assistance, please contact local representative or directly to factory

P500 v2.5.1 14
DIATRON MI Zrt.
H-1097 Budapest, Táblás u. 39 Hungary
Phone: +36 1 436 9800 Fax: +36 1 436 9809
www.diatron.com

SAFETY SYMBOLS

Warning: Before using read instructions in Manual

Hazardous Voltage

Ground connection

Biological Risk

DIATRON MI Plc.
EC REP 1300 Budapest 3. PO Box 134
P 1097 Budapest. Hungary
Táblás str. 39
Phone +36 1 436 9800
Fax +36 1 436 9809
e-mail:@diatron.com

P500 v2.5.1 15
DIATRON MI Zrt.
H-1097 Budapest, Táblás u. 39 Hungary
Phone: +36 1 436 9800 Fax: +36 1 436 9809
www.diatron.com

Safety symbols

Warning: Before use read instructions in Manual

Hazardous Voltage

Laser radiation risk (BCR)

Biological Risk

P500 v2.5.1 16
DIATRON MI Zrt.
H-1097 Budapest, Táblás u. 39 Hungary
Phone: +36 1 436 9800 Fax: +36 1 436 9809
www.diatron.com

3 Introduction
This autoanalyser is a reliable in vitro diagnostic analyser for continuous automatic
testing of clinical chemistry tests and electrolytes in serum, plasma, urine, other biological
fluids or whole blood (HbA1c).

Being a real random access analyser with stat capabilities, this clinical chemistry analyser
is the ideal solution for small to medium sized laboratories, with a throughput of up to 300
photometric tests/hour (480 tests/hour with ISE).

Continuous processing can be achieved as samples sectors and reagent vials can be
loaded quickly and simply allowing nonstop operation. Sample sectors can hold primary
tubes and small sample cups. BCR can be activated for all and individually.

A refrigerated reagent tray can hold up to 72 different containers ranging from 20 to 70

mL depending on configuration.

The optional ISE unit can produce simultaneous electrochemical measurement of Na+,
K+, Cl- and Li+ with automatic urine sample dilution. Other electrodes are also available
upon request.

The instrument is controlled by a PC workstation that has a graphical-user friendly-

interface software. The software provides complete control over the analysing process
and allows easy access to advanced statistical functions and reports.

Versatile method set-ups comprises end point, fixed point, kinetics, Ion Selective
Electrodes (ISE), coagulation, calculated and external.

Optional features include:

 Flexible pre and post washing for each test to prevent harmful carryover.

 Auto-rerun with automatic dilution for out of linear range samples.

 Criteria for automatic duplicates for result confirmation.

 Extra volume dispensing with water or reagent to improve accuracy.

 Reagent integrity check for safe operation.

 Automatic pre-set values for calibrators, controls, blanks and samples to fit
method inserts.

 Curve and linear calibration with unlimited number of standards for high accuracy.

Other advanced features include:

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DIATRON MI Zrt.
H-1097 Budapest, Táblás u. 39 Hungary
Phone: +36 1 436 9800 Fax: +36 1 436 9809
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 On-board sample and reagent bar code reading assure positive identification.

 Capacitive sensors monitor sample and reagent volumes.

 Instant mixing during dispense gives precise initial reaction time.

 Automatic acceptance for calibrators, blanks, controls and samples, together with
smart alerting messages increase the walk-away time.

 Current activity window indicates to the operator when the routine will be finished.

 Clot detector, vertical and parallel collision sensors.

 Low water consumption.

3.1 Main components and views

Figure 1-1: Front view of the Autoanalyzer

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DIATRON MI Zrt.
H-1097 Budapest, Táblás u. 39 Hungary
Phone: +36 1 436 9800 Fax: +36 1 436 9809
www.diatron.com

Figure 1-2: Rear view of the Autoanalyzer

Figure 1-3: Top view of the Autoanalyzer

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DIATRON MI Zrt.
H-1097 Budapest, Táblás u. 39 Hungary
Phone: +36 1 436 9800 Fax: +36 1 436 9809
www.diatron.com

Figure 1-4: Right side view of the Autoanalyzer

3.1.1 Samples & sample sectors

Samples are loaded in 19 position sample sectors. Continuous processing is possible by

the use of different bar-coded sample sectors, which the user can insert or remove from
sample tray during analysis. If sample and sector BCR are activated, after loading the
sectors, each sector is recognized and samples are immediately identified by direct
barcode reading. Five segments can be present simultaneously in the sample tray, while
up to 99 external (out of tray) sectors can be handled by the system. STAT samples can
be loaded in special high priority sectors to be processed. A standard sector holds 19
bar-coded primary tubes or 19 cups or a mix of both. Special sectors for 16 mm external
diameter tubes are available upon request.

Sectors can hold:

Micro cup: 0.5 mL
Standard cup: 1.5 mL
Primary tube: 5 mL (13 x 75 mm)
7 mL (13 x 100 mm, 13 x 75 mm)
10 mL (16 x 100 mm)

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DIATRON MI Zrt.
H-1097 Budapest, Táblás u. 39 Hungary
Phone: +36 1 436 9800 Fax: +36 1 436 9809
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Figure 1-5: Standard 19 position bar-coded sector

3.1.2 Reagents

The analyser has a cooled reagent tray where 25 mL, 45 mL and 70 mL containers can
be placed. The reagent tray includes integrated barcode reader for 24 inner and 24 outer
positions. Inner positions can hold two reagents in split containers increasing the total
number of on-board reagents to 72. Dilution and buffer solutions are also placed in the
reagent tray.

Inner position

Outer position

Split containers

Figure 1-6: Reagent tray and different containers positions

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DIATRON MI Zrt.
H-1097 Budapest, Táblás u. 39 Hungary
Phone: +36 1 436 9800 Fax: +36 1 436 9809
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3.1.3 Cuvettes

Samples and reagents are dispensed into a multiple cuvette strip. Each strip has 5
cuvettes. The reaction tray holds 16 strips of cuvettes giving the system a total of 80
cuvettes.

Figure 1-7: Cuvettes strips

3.2 Software functions overview

The software offers complete functionality to control the instrument and monitors the
overall operation which includes: samples and patients management, reagent inventory,
program tests, calibration of methods, perform QC tasks, follow up of reactions and result
statistics.

3.2.1 Levels of access

System has different levels of access depending of the type of user:

Operator

Normal user

Power user

Supervisor

Service

Select in main menu:

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DIATRON MI Zrt.
H-1097 Budapest, Táblás u. 39 Hungary
Phone: +36 1 436 9800 Fax: +36 1 436 9809
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Select Log as Power User, Supervisor or Service and introduce a corresponding

Password.

Log Out option will return to operator level. Main menu allows the modification of
passwords.

Normal User is the default condition. In this case, only system operation is possible.

Power User can define control sets and calibration sets.

Several actions described in the present manual will be available to the Supervisor only.
They will be indicated with the symbol:

For actions when the user is defined as Service, please refer to the corresponding
manual.

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H-1097 Budapest, Táblás u. 39 Hungary
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3.2.2 Other functions included in Data menu.

With the Import function, the operator can retrieve several configurations, other than the
software database (...\Program Folder\Database). Importable information is for example:
Methods, QC Sets, Calibrator Sets, Units Conversion and Translator.

The Service Backup item allows the creation of an instrument image for servicing
purposes and additional safety.

The Reconnect option checks and establishes communication between the software and
the analyser (hardware). The Close Program option shuts down the software. It is
recommended to perform it as well as restarting the computer on a daily basis.

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3.2.3 Main screen

Menu & Quick

Keys
Current activity
Control Bar

Requests to Tests in progress

operator
ISE activity &
System messages reagent pack
volume

Tip, ISE, flush,

cuvette blank Reagent Inventory
requests
Calibration and
reagent status
System alerts

Transmission and
operating status

Main screen combines the information required for instrument operation, allowing user to
check for instrument status at a glance and intervention (when required) at a glance.

Quick keys menu provides direct access to the major program functions.

Main
To review the information about current run.

Patients
To set demographic data and relevant information.

Samples
To define and order chemistry, ISE, coagulation and calculated tests.

Tests
To review pending reactions and test results.

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Reagent tray
To graphically insert or remove reagents in tray.

Sample tray

To graphically insert or remove samples and sample sectors in tray.

Reactions
To graphically review cuvette usage, change and wash cuvettes.

Calibrations

To request and browse pending acceptance, in use and historic calibrations.

BLK Blanks

Definition, review and acceptance of reagent blanks.

Quality Control
To request or browse QC results and statistical and graphical functions.

Methods
To browse and edit definitions of methods.

Main operation control tool bar gives control over major automatic routine operation.
Use:

Initialize
To initialize all the instrument units to rest positions.

Start
To begin the routine operation.

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Stop
To stop the routine operation.

Suspend and re-start dilutions

Allows momentary interruption of dilutions for sample and STAT load.

The Running Options can be selected According to operator requirements which depend
on the moment and opportunity.

Non-stop operation: When this option is selected, the automatic cycle does not finish
and after analysis the instrument goes to stand-by mode. This option is recommended
when additional samples are expected soon for processing. When daily work is
completed, the option must be de-selected.

Use this option cautiously.

Process ISE assays: Disable if no ISE samples are expected within the daily workload.
This option will not be shown if ISE module is not enabled.

Process Coagulation assays: Disable if no coagulation samples are expected within the
daily workload. This option will not be shown if coagulation methods are not enabled.

The bar of requests and warnings to operator provides actions requested to

instrument to complete some operation, such as confirmation of calibrations, validation of
sample results outside reference limits, etc. System alerts and Logs are also indicated
here and warnings such as tip and ISE cleaning request are also issued if the previous
cleaning cycle has not been completed.

Messages list registers the relevant notes and warnings that the instrument operation
generates such as control out of limits, run out of sample.

Fluid Levels window provides monitoring real-time information of system, cuvette cleaner
and waste water levels.

Transmission and operating status displays the communication status between the
computer and the instrument (Connecting, Online or Offline and Operating) and the
phase of operation (Pre-automatic, automatic or post-automatic, LIS communication
status).

Current activity and summary contain relevant information about tests in progress,
next dispensing/reading operations and remaining readings and dispenses as well as

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approximate time of completion. Additionally, ISE status and operation are indicated as
well as the remaining content of ISE reagent pack

Test in progress provides the list of processing tests.

Reagent status table show programmed tests from on-tray samples plus information of
reagent availability. With a mouse right click option, detailed explanatory information is
displayed. Further, calibration status and reagent presence, expiration date and reagent
blank are indicated.

General status bar shows context-sensitive help or information like calibration and blank
expiration dates and times.

Menu bar gives quick and comprehensive access to many program functions

3.2.4 Relevant screens

Data such as patient name, sample type,

MD, diagnostic can be included.
Also the assignment of samples to each
patient can be performed.
For calculated methods, if more than one
sample is involved, all must be assigned to
the patient.
The patients window can also be accessed
directly from samples window.

Data from samples are added to this

identification screen: Id, type, collection date.
Also tests and number of replicates are
incorporated.
This load can be performed method by
method or with the aid of “quick load” table
and/or Profile screens.
Patients can be defined with the button
located to the left of Patient Id.
Sample positions in sectors can be
allocated.

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Flagged and calculated results can be

validated and/or repeated.
External results can be inserted, to
complete reports and calculated methods.
Assigned samples are listed and
performed tests are indicated on the right
table per selected sample.
Test results can be printed and exported.
Data storage of sample is unlimited.

From the main menu it is possible to access the

reagent tray programming to allow the placement
or removal of reagents or solutions.
The second reagent of any given double reagent
method will be marked with a dot.
Slide mouse over a reagent on the tray to obtain
details on the top right panel regarding reagent
usage, available volume and pending reactions.
Alternative views of reagents and calibration
status are available.
Click Apply changes to can place/remove/refill
reagents and solutions.

Sample tray consists of five sectors of 19

samples in each.
User can prepare and load additional sectors
while instrument is operating.
Primary and secondary tube options are
available in order to differentiate the bottom
of the tubes and accommodate to low volume
samples.
Stat sectors and sample positions are
indicated with red colour.

To get information (position, state, result of the

cuvette check and last method) about the
cuvettes on the tray click on the reaction tray
graph.
Cuvette wash, change and check could be
performed.
Information about the cuvettes can be also
printed.

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Calibration by a single standard and multipoint

methods can be defined, performed and
scheduled at this window.
A calibration set is a group of data defining
tests, standard solutions and concentrations,
allowing any combination of multi-point and
multi-calibrators.
Once defined, user can confirm pending
acceptance and browse in use or historic
calibrations.

Additional reagent blanks can be

programmed from this window.
Blanks can be viewed and validated if
within automatic set up limits
Historical results can be viewed and
assessed in order to help reagent
performance troubleshooting.

Definition of control sets makes easy to

check on-board reagent integrity and
system reliability.
Levey-Jennings plot and Westgard multi-
rules are integrated to facilitate QC
analysis.
Twin QC is designed to relate high and low
controls and get an accurate statistical
picture.
Scheduler is designed to program controls
at pre-set dates.

Versatile method set-ups include end point,

fixed point, kinetic, ISE, calculated and
externals.
Application parameters are set and divided
into sections
Method parameters comprise principal and
side wavelength, sample and reagent
volumes, additional dispensing with water or
reagent, direction check, reagent and sample
blanks, automatic re-dilution of high samples,
reagent absorbance check, reference class
limits settings and advanced pre & post
washing options.
Cleaning, rinsing and diluent solutions can be
also defined.

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4 Installation
4.1 Unpacking

Important: Check carefully the packing list included in the shipment after unpacking.

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First the blue fixing parts on the edges of the crate have to be removed. Use a flathead
screwdriver.

Second remove the walls of the crate

Third to take out the instrument, it has to be slid to the direction marked by red arrow

4.2 Instrument set up

WARNING:

 The analyser is a heavy instrument (more than 95 Kg). At least two persons are
needed to move it. The lifting arms must be used!
 Take care to leave at least 10 cm from walls or other equipment to permit sufficient
air flow for cooling.
 Make sure during installation and maintenance the instrument is properly levelled. It
is very important in order to ensure proper draining of the reagent chamber from
condensed water which accumulates on the bottom of the reagent chamber while the
cooling system is on.
 Do not expose to direct sunlight.
 Do not place near or in front of heat sources.
 The instrument must work at pressures above 600 hP.
 The room temperature must be lower than 30°C

4.2.1 Installation requirements.

Carefully read the safety instructions included in this manual.

Install the instrument on a solid horizontal table that can support the weight of the
instrument. Select a well-ventilated, dust free location.

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Main electric should be close to the instrument (less than two meters) and must fulfil local
regulations.

Free access to main switch and main cable’s plug is required. A distance of 50 cm from
the left side of instrument to nearest table or wall is advisable. The right side must have at
least 30 cm of free space for ventilation purposes.

Space must be empty over the instrument to 2.10 m. Avoid using shelves, walls or
screens above instrument.

The instrument must have 2.10 m of free space above it. Avoid using shelves, walls or
screens above the instrument.

1. Unpack instrument

2. Connect peristaltic pumps tubings.

3. Take out the plastic protection tube (typically yellow) from the vertical shaft of the
probe arm before operating and tip protection.

4. Connect waste, DI water, and cleaner tubes to the instrument

5. Connect them to the each jerry can. (check connector colours)

6. Cut tubes to length in order to prevent a U shape below bottle level. Tubes must
go directly to each jerry can.

7. Fill DI water and cleaner bottles.

8. Install SW

9. Connect instrument and scale to the computer

10. Turn on instrument

11. Start Software

12. Reconnect. Do not initialize.

13. Calibrate filter wheel (remember to remove cuvettes).

14. Fill with reaction cuvettes.

15. Perform full mechanical calibration (or check them).

16. Perform system flush

17. Perform washer volume calibration

18. Perform photometer calibration

19. Check scale calibration and recalibrate if needed.

20. Initialize

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4.2.2 Electrical connections

Plug in the mains cord to a socket with ground connection. The power requirements for
the analyser are as follows: 100-240 VAC, 50/60 Hz, 600 VA maximum.

WARNING: Instrument is Installation Category II. Instrument requires protective ground

connection. Verify ground connection before installing the instrument.

Maximum voltage between ground and neutral lead: 0.5 volts.

WARNING: Users must be aware of the danger of using the analyser with abnormal
grounding. It is advised not to complete installation with poor grounding conditions.

Connect the analyser to the computer via USB connection.

4.2.3 Hydraulics

The waste deposit collects the drainage from the probe washing stations and occasional
waste from the dispensing stations and cuvette washers. Place the empty bottle at the
correct location and in the correct orientation (see

Figure 1-4). Pay attention that the funnel is inside the bottle neck. The waste bottle has a
capacity of 10 L.

The washing solution is prepared by diluting of 2 mL of additive (Sol. 3) per litre of DI

water. The capacity of the system water bottle is 5 L. Purified water should be used with
less than 2 µS/cm and less than 100CFU/ml for routine analysis to avoid contamination of
the system with ions and bacteria. Described specifications fall in CLSI Type 2 water
category.

Level metering is made by means of a load cell system (scale) for DI system water and
waste bottle. Warning messages will appear before the system water is empty and the
waste bottle full.

Put the pump tubing of the washing pumps in place.

Take out the plastic protection tube (typically yellow) from the vertical shaft of the probe
arm before operating.

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The system is ready to run. Flush the system at least 3 times in order to ensure that all
bubbles have been removed from the tubing and syringe.

4.2.4 Handling of biological fluids

Before connecting wash and drain lines, ensure to review and understand the regulations
and hazards about the use of potentially
dangerous biological fluids.

Keep in mind the following considerations:

Due to the presence of biological fluids, some

instrument areas are potentially dangerous.
They have the following with the warning
symbol.

Dispensing tips, reaction cuvettes and drain fluid

bottle are the most hazardous areas.

All sample handling, drain fluid disposal and

reaction cuvette replacement must be done
while wearing safety disposable gloves and
goggles according to local regulations for biological fluids handling.

Drain fluid must be neutralized before disposal. The addition of 0.5 % Sodium
Hypochlorite is suggested.

Verify and use local regulations on discarding pathological fluids.

If instrument is to be transferred to another location or stored for a long period, perform at

least 5 purge cycles, remove cleaning solution bottle and repeat purge cycles until drain
lines are empty. Neutralize and dispose drain fluid accordingly.

NOTICE: Never dispose potentially dangerous fluids in a public drainage system, always
follow the local national regulations.

4.3 Computer setup

Follow the instruction set of the computer’s manufacturer to connect and operate the
computer system.

The minimum requirements for the computer are:

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Processor Intel Core i3 or higher

Memory: 4 Gb Ram

Video board Graphics Enging GeForce 8400 or equivalent

Monitor 17" (VIS 15.7")

Display resolution 1024x768 or higher (vertical refresh > 70 Hz)

Colour quality 16 bits

Hard drive 500 Gb SATA 3 7200 rpm or better

CD-RW or DVD -RW or DVD-R

Keyboard 105-key Performance keyboard

Pointing device USB mouse

Soundcard Integrated 16 bit

Speakers

Network adapter Ethernet 10/100 Mb

Serial Port: LIS connection, (USB to RS232 adapter – optional)

USB Port: 6

Operating system: MS-Windows 8.1 or Windows 10, 64 bits

Alternatively, use standard configuration recommended for the operating system.

Compatible printer

Notice: Windows should have been updated prior to installation

The computer should be used exclusively for the instrument. Program performance
could be affected by simultaneous usage with other software. LIS must be installed in a
separate computer connected via the serial port.
It is recommended to restart the system every day in order to keep the work station
up to speed.

Antivirus: Some of them will require additional memory and resources. Working directory
and executable must be excluded from real time analysis. Scheduled/automatic analysis
must be disabled.

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4.4 Parameters

A few parameters for software and instrument use are accessible to operators and these
are located in below screen.

4.4.1 Software

Includes pages for communications, LIS and bar code reader.

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General

1. Communications: Select the serial port according to the computer setting and
specification. If settings are incorrect, the analyser temporarily checks for another
port; if no ports are free, program might not work properly.

2. Language: Select language from the library already set in the translator. Changes
will come into effect when program is closed and re-opened.

3. Historic: Defines size in days and numbers that calibrators, controls and samples
will stay in “upper” memory. Controls and samples above these days will be stored
at the cumulative historic files and can be recalled.

4. Random access. Two options are provided: batch and full random access.

5. Coagulation (service only): Enables/disables coagulation mode.

6. On-line printing Enables printing; selection of printout of pending acceptance

samples and printout of manually accepted results

7. Automatic: Selection of active warnings and software behaviour on a number of

different routine analysis. ISE processing check can be enabled by default with a
parameter. The DI empty warning can stop dilutions if checked and issue warning,
but continue (with warning) if not checked.

8. Automatic acceptance: The automatic acceptance can be conditioned or not by

the reference classes values. In other words, it can be programmed that values
within the reference class are automatically accepted and the others, not. The

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same applies also for replicated results due to a flag or manual repetition and
reused calibration for particular reagents.

9. ISE processing check can be enabled by default with a parameter.

10. The DI empty warning can stop dilutions if checked and issue warning but
continue, if not checked.

11. Patient window: selection of display

12. Clot behaviour: Enables the use of clot behaviour and offers additional options in
analyser behaviour in case that clot is detected see section 5.1.1

13. Sample default type. Defines which sample type will be used as default on sample
creation.

14. Reagent integrity check. In case that reagent integrity check is activated, it
provides additional options on frequency of checks.

QC

1. Westgard Rules. Options of which rules to be indicated at Levey Jennings Plots at

the QC Done section

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2. Summary. Options of QC results to be highlighted at the Statistics window are

provided.
Press Apply Changes in order to save any modifications.

BCR

1. BCR. Can be activated for samples, reagents and sample sectors by checking the
corresponding box.
2. Reagent configuration. Select setting according to your requirements. This selector
defines options for Method, bottle type, expiration date format and starting position. In
case of the closed parameters, values are predefined and no intervention is
necessary.
3. Sample configuration. This option for sample barcodes enables the use of only part of
code, starting from a given digit and taking a given Length. If Id position is not
selected, all code digits are read.
4. Reagent no read behaviour. Option for software to ask at the end or each time after a
bottle’s barcode has not been read and/or identified. Applies only when barcode is
activated for reagents.
5. Lot Number. The option of mix lots is checked if more than one lot of the same
reagent have to be on board the reagent tray and calibrated on the same time.

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LIS

1. Enabled. Sets communication with host computer.

2. Options. A number of options at the bi-directional communication are provided in
order to facilitate communication between the LIS system and the analyser
software. A separate LIS manual is provided in order to provide guidelines on how
set up these parameters and they are selected according to specifications of your
LIS provider.
3. Translation. Establishes an equivalency of patient sex type between the LIS and
the analyser software set up.
4. Coding. Sets the communication code with LIS software.

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4.4.2 Use

Use parameters are split in several sections: Cuvette absorbance limits, sample vials and
ISE parameters.

1. Cuvette blanks. Includes upper and lower limits in cuvette testing. Tolerance refers to
the allowed median absorbance variation for air and water cuvette blanks. Values
indicated at above photo are pre-set and is not recommended to be changed.
2. Sample vials. Two different sample vial diameters can be defined. This feature is
useful to define paediatric vials. Volume calculations require careful section
measurement for each defined vial.
3. ISE. User determines if additional pre washes are required before ISE
measurements. For details, see ISE section.
4. ISE Medica. User can enable or disable any electrode which is not installed if all four
are not needed.

4.4.3 Reports

This section allows sorting how methods are ordered in report and printout. Keys Up and
Down allow moving methods to different positions in the final printout. If not enabled
sorting will take place alphabetically.

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4.4.4 Sector definition

In this section user defines the number of sectors that are available on the analyser. Up
to five sectors can be on board the sample tray at one time but up to 99 ones can
programmed and be available for loading. Here user determines if a sector is defined as
STAT or not. If so, all samples loaded in the sector will be processed with priority over
samples of other sectors.
Define a new sector with a number and assign the STAT condition, if required. Be sure
that number is not already defined in the column to the right. If so, first delete definition
and then re-enter new definition, including STAT condition.

4.4.5 Debug

In this section a number of hardware parts can be deactivated and activated accordingly.
Temporal deactivation of Front or back arm could be beneficial to avoid down time if an
issue renders one of the probes unavailable. On the same time similarly deactivation of
washers and sensors for DI water and waste bottles could minimize ‘’down’’ time.
Additionally DI water and waste bottle sensors could be deactivated in case of an auto
feed/drain system.

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4.5 Tools

4.5.1 Translator

Translator operates on the language selected in Software parameters.

There are two basic ways of translating: translation control and dictionary. To translate by
translation control, place mouse pointer on the screen and phrase which text must be
modified; press keys Shift + Control + C. The following screen will open:

Left column is the Instrument Internal Language. It is mostly English; second and third
column are the present translation, if any. Text may be local or global, that is, can be
used only in the selected position or used in different screens. Modification can be local
or global. Global modifications affects all entries of the same text. In case of doubt,
perform local modifications only.

IMPORTANT: End each modification by pressing the CTRL + SHIFT + C keys.

Modifications take effect only when program is restarted. When a given translation is
empty, system will use internal language, no matter which language is selected.

For translation with Dictionary, select:

Maintenance > Tools > Translator.

When any entry is selected, upper window shows internal text and lower window, the
translation, if present.
Sorting can be performed by internal or by translation. There is also a built-in search tool.
Entries can be deleted by pressing the corresponding button.

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4.5.2 Modify reports

Customized printable reports can be modified at will by user in

Maintenance > Tools > Modify Report.

At top right there are four bands (title, header, data and footer) which in a way split the
report in 4 separate sections. By clicking at the + button next to each band a variable
number per band of additional text captions will appear.

Title Band includes only one option: title caption. Select in the upper right window the
“txtCaption” option and press Edit. The New/ Edit Text screen will show up:

Text, position, size, font can be modified in this screen. Additional ‘txtCaption’ fields can
be added at any band by choosing Add Text and Add DataText options. Positioning for
a particular caption is assigned by inserting values for distance from left, top and the
width of the text.

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Press on the + symbol in any Header band and a complete listing of possible fields will be
displayed. There are two types of fields: DataText are the Results written by instrument
once a value is printed and Texts ones which indicate the label to be printed. In case of
DataText options, they can be moved, eliminated, changed font, etc. but its text is out of
operator's control. There are also Report variables that can be added at this time. They
include page numbering date and time in different possible formats. In the New/Edit Data
Text, the Change button allows selecting the desired field to be shown. The Texts are the
true headers corresponding to the Data texts and can be fully modified. When the Edit
button is pressed, the following screen is seen:

As an example, the following report format is included in software. In order to get below
configuration on screen press Generate Data option at bottom left. User can experiment
on adding, removing and modifying printed fields and can preview modifications on
screen before saving the changes.

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5 Get ready for operation

Complete all the steps pointed out in the preceding chapter before continuing.
After verifying correct voltage settings, connect instrument and computer to mains. The
suggested start-up sequence is:
Turn reagent cooling system on by pressing green button lateral on the front panel.
Turn printer on.
Turn monitor on.
Turn instrument by pressing the red button on the front.
Turn computer on.
Once operating system is ready, activate the desktop's program icon to open the
Autoanalyzer program.
Accept the start-up offered by the program, wait until operation and checks finish
(operating is not highlighted) and there are no visible warning messages on the screen.
Otherwise, refer to the troubleshooting chapter in this manual (see chapter 10).

Caution: Do not change the computer date or time during operation. The current
operation will be aborted and all in-progress reactions will be lost.

5.1 Automatic operation

Load of method definitions, samples, analysis, profiles, etc. will be described in detail in
the next chapters. Here, the automatic measuring procedure will be outlined.
Once samples and reagents are loaded, Main window will show pending analysis,
present and required reagents, and any other flagged condition. If one or more samples
are not listed, verify that sample sectors and samples are already positioned in sample
tray and have been assigned.

Important: Pending samples are shown when samples are loaded on tray and tray is
already positioned in instrument.

Press the startup (key) button

All system alerts conditions will be tested (clot detector, wash and diluent
solutions, drain, pump tubing, syringes and drying blocks cycles). If any
debugging condition is set, a warning will be issued at this time. Additional
warning messages will be issued if maintenance procedures have not been performed, if
reagent blanks and calibrations are not valid and reagents are missing or not enough to
complete programmed operation.

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There are three cycles (shown at the bottom bar of the screen):
Pre-automatic

Automatic

Post-automatic

Indication of operation in progress is shown in the screen in green colour. Pre-automatic

cycle includes initialization, warming up and cuvette testing. System halts if more than 20
cuvettes are dirty in any tray and a warning is issued. No new sample entries are allowed
in this period. A warning is also issued if cooling system is off or defective but no further
action is required.

Automatic cycle includes reagent testing, integrity check, test analysis and calculations.
Also printouts can be generated in this period.

Post-automatic includes cuvette washing (remaining used cuvettes, probe cleaning and
conditioning and remaining printout).

If Non Stop operation has been selected, instrument remains idle (stays at automatic
condition) until new samples are introduced or check box deselected.

5.1.1 Clot detector

System has two clot detectors, one in each probe. They operate based on a differential
pressure principle.

Clot detector is installed in

Maintenance > Service > Parameters > Instrumentals > Others
Detectors are automatically calibrated when automatic cycle starts. Several working
conditions can be adjusted. They are defined in Section 4.4.1:
Maintenance > Parameters > General
and modified with Supervisor privileges. Operation of clot detectors can be enabled or
disabled; if clot is detected, then sample can be repeated or not.

The clot condition will be posted in the details of the sample result.

If sample is discarded, it will continue as in process and a message will be shown in the
window of messages in main menu. Clot detector version is posted in the ErrorsLog.txt
file.

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6 Routine tasks
6.1 Reaction Trays

To inspect the reaction trays press the Reaction Tray button. Window will display the
reaction cuvettes.

6.1.1 Changing reaction cuvettes

To change reaction cuvettes press the icon indicated on the left.

Then;

Push Change button.

Open main cover and reaction trays cover.

Replace cuvettes. Close reaction trays and main covers.

Push OK when finished.

It is important to change all reaction cuvettes on the same time since

VERY IMPORTANT: replace all on board cuvettes with new ones on the same time since
one of the criteria used to define clean cuvettes from void ones is using the median value
of absorbance +/- the tolerance and cuvettes that are failing this will be marked as void.

6.2 Reagents

6.2.1 Reagent tray

VERY IMPORTANT: After the placing or removing reagents as described below, user
should press Apply Changes to start the positioning sequence for reagent
placement/removal.

To inspect the on-board reagents press indicated icon. The reagents tray
window is displayed showing a graphical representation of the actual
distribution of reagents in the tray. At start up either manually assign positions
for each reagent or read the bar code labels.

Each bottle shows the first three letters of its method name. When two or more method
names start with the same three letters an asterisk (*) is shown for both. One dot under

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the name indicates second reagent of the same method (R2) and two dots a third reagent
(R3).

Detailed information of each reagent bottle is displayed in the right panel; just point with
the mouse to the desired position. Each reagent belongs to a certain method. Substitution
(sharing) of reagents can be applied for some methods. Information includes the owner
method name and reagent number, the number of tests that can be performed with the
present volume, the number of pending reactions for the method, the date that the
reagent was placed on board the analyser and the expiration date of the specific lot. More
than one vials for each method can be defined or inserted. If so, when the first defined
vial is exhausted the reagent intake will automatically be transferred to the next one.
Multiple lots of the same reagent can also be placed simultaneously on the reagent tray
and separately calibrated.

The colours used for positions allow to easily distinguish between reagents, diluents, free
positions and shorted solutions as follows:

Green reagent in position and in use (programmed samples)

Blue diluent
Yellow Reagent not in use
Light Grey free position
Dark Grey reagent not in use or removed ( additional action required)
Red* No active calibration for reagent

*Red coloured reagents are only shown at calibrated view which can be selected from the
View option at the right side of the screen.

6.2.2 Loading bar-coded reagents

To load bar-coded reagents right click a suitable position and pick Change & Bcr
check, to set the position for a bar-coded reagent position. A question mark symbol will
be issued at the specified position. In case of 2-reagent methods with split internal
orientation bottles (45 & 25 mL bottles), the BCR will read the outer barcode label and
automatically assign the internal position (information included at barcode label of
external vial/reagent).

Press Apply Changes to start the positioning sequence for reagent loading into the tray
and barcode reading. Alternatively, reagents can be randomly placed in positions and
press BCR All button at bottom of the screen; all positions will be checked and barcoded
reagents will be identified/positioned.

When a reagent is not included in the table of Methods in Use but its code detected as
located in the tray, it is automatically included in the methods in use.

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If a reagent barcode label cannot be read and/or a solution or reagent does not have a
label below window will appear

In case that the barcode cannot be read, enter

manually the code into indicated window and click
ok.

Alternative, if a
solution or reagent does not have a barcode label click
ok at above screen and additional window will appear
in order to confirm solutions and reagents without bar
codes. Review and check (tick) each corresponding
box in order to accept their use. Click OK in order to
confirm.

When a reagent does not have barcode, in order to

speed up the reading procedure, it is advisable to
place a Dummy code on it. The Dummy bar codes can
be printed out by selecting
Reports > Dummy bar code

6.2.3 Loading non bar-coded reagents and solutions

VERY IMPORTANT: After placing or removing reagents as described below,

press Apply Changes to start the positioning sequence for vial placement/removal.

 To define a reagent in to the tray, press Place Reagent , then from the window
select or type in the reagent ID field, reagent number and desired position, switching with
Tab key. Press Ok or Enter key when done, or press Cancel or Esc key to abort. Defined
reagent position will exhibit dark grey colour.

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To define a diluent or cleaning solution in to the tray press Place Solution , select or
type in the desired solution and proceed as above.


 Alternatively, to define a reagent or solution at a particular position in the tray, right
click a suitable position and pick Place Reagent, Place Diluent Solution, Place Cleaning
Solution options, select desired reagent or solution. Press Ok when done or Cancel to
abort.

Even if a reagent is in the tray, a new vial of the same method can be defined. The first
loaded will be used first and upon its completion, the second one will be checked and
used. The “+” symbol located in the right side of a reagent means that it is already
defined in the tray. There is no limit to the number of vials of the same method in the tray.

 Press Apply Changes and the reagent tray drives the selected position to the vial
insertion area. Message will be:

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 Open the reagent tray triangular cover, insert the reagent or solution bottle and close
the cover. Press Ok when done to confirm the operation. If more than one reagent is
loaded or removed, several messages will be shown in sequence.
IMPORTANT: If Apply Changes is not pressed, selected positions will remain in
dark grey colour and cannot be used.

6.2.4 Removing reagents and solutions

 To remove reagent/s from the tray, press Remove Reagent, select one or more
reagent/s or desired positions. Press Ok when done or Cancel to abort.

To remove a diluent or cleaning solution from the

tray press Remove Solution , select or type in
the desired solution and proceed as above.

To select more than one item from the

list, press and hold Ctrl key while
selecting the new item. To select a range
of items, select the first item, then press
and hold Shift key while selecting the last
item. Alternatively for extended selection
use the mouse by click and drag

 Alternatively, to remove a reagent or

solution from a particular position in the tray, right click the desired position and pick
Remove option.

 Press Apply Changes and the Reagent tray drive the selected position/s to the bottle
insertion/removal area. You will read:

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 Open the reagent tray triangular cover, take out the reagent or solution bottles and
close the cover.
Next, to confirm the operation press Ok button when done.
Same procedure must be followed for removing diluents and solutions.

6.2.5 Re-filling reagent bottles

When pressing right button over a given reagent, menu will include a Refill option. Once
the Apply Changes button is pressed, tray will move in the desired reagent position.
Several reagent vials can be refilled with this procedure: when Apply Changes is
pressed tray will sequentially position in all the defined refilling reagents. The dilution
restart is automatic.
Note, that when barcoded reagents are used the re-fill option might not available.

IMPORTANT: Before starting automatic procedure, volumes can be tested. Press Check
Volumes button for this operation. Additionally, a reagent and available test report can be
viewed or printed out by clicking on Available Tests.

More than one reagents trays can be prepared and

saved in memory in case additional tests are
required and can not fit simultaneously on the
reagent tray. Additional reagent trays can be
created, accessed and chosen through the In
Memory button.

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6.3 Samples

Samples can be loaded directly or associated to patients. Chemistry methods are

assigned to samples and not directly to patients. External methods are always assigned
to patients and calculated methods are assigned to patients and when calculation implies
a chemistry measurement, to samples.

6.3.1 Working with patients

To create or work with patients press button. The patients' definition window is
presented below:

Only Patient Id is a required field. All others are shown in the patient's report.

The lower left window shows samples assigned to the current patient, the following window
(to the right) shows tests exclusively assigned patients (externals or calculated), the
window to the most right, displays the all defined patients.

A Patient ID cannot be modified, unless the whole entry is erased. Data are automatically
confirmed once written.

Delete All button will remove all samples from the queue

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6.3.2 Defining sample data and tests

To define new samples or request tests for a given sample, press the
corresponding button. The sample definition window is displayed.

 To edit information for an already defined sample, first select the sample from the list
on the right and then press Edit button, then press Browse (Edit button automatically
switch to Browse if pressed once) to switch to navigation mode.

To enter or define a new sample, press New button.

Complete the required information and press Ok when done or Cancel to abort.

To request new tests for a sample, first select the sample from the list on the right window
and then either:

Press Add Test. Choose from Photometric, ISE, External or Calculated type as well as
profile, and select or type in the desired method.

Press Ok when done or Cancel to abort.

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Patient Id, Name and Last Name can be added at this time from a list of already defined
patients. When sample is in Edit mode and button located on the right of the Patient Id
window pressed, a screen with available Id, Last Names and Names opens and the
selection can be made.

 Alternatively, double click on the desired methods or profiles, in Quick load panel or
Profiles panel.

When replicates of the same sample are required, use the Add Test button or press
method ID several times in the Quick load window.

Without requiring its introduction in a STAT sector, any sample can be defined as STAT
at all times by checking Stat Sample. This will enhance its priority over other samples.
For details, see Section 0.

To define Test Profiles, go from Methods – Profiles (see corresponding section for
details).

The Low volume checkbox defines a flagged situation required when low samples
volumes are collected. In this case, the instrument will search for sample level and, if not
found, aspiration will be performed with the tip located 1 mm above the vial bottom. The
flag is also shown in the run tests window and the automatic acceptance condition,
suspended.

In case of a high concentration limit situation defined with predilution, if the sample was
defined with Low volume, the instrument will select “less sample” instead of “predilution”.

Patients can also be defined directly from the Samples window. By pressing the grey
button located to the right of the Patient Id, the following window opens:

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If the Patient Id is not generated in this pop-up menu, an automatic patient Id will be
created when the “+” button will be pressed. Its structure will be: YYMMDD+”.”+Sample
Id. Demographic information can also be added from this window.

The patient information can be recovered from the historic data when a new patient is
created. This is true if the generation is from the patient or the sample window. The
software stores one copy of patient information in the historic data. It is understood that a
Patient Id defines a physical person.

6.3.3 Removing a sample

 To remove a sample from the list press Delete Test :

Then press Yes to confirm or No to abort.

Delete All button will remove all samples from the queue.

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6.3.4 Removing tests

 To remove tests from a sample, first select the sample from the list on the right
window and then press Delete Test . Select tests to remove from the list.

Press Ok when done or Cancel to abort. Multiple tests can be deleted from a
particular sample by keeping pressed the Ctrl button from the keyboard and selecting the
desired tests to be deleted.

6.3.5 Copy data

New samples can be generated by copying data from another sample. Press Copy button
and a window will open for selection of number of replicates. New ID numbers will be
correlate to the original one. If alphabetic characters are present in the ID, new digits are
added.

6.3.6 Loading samples

To manage samples and sample sectors or to review the sample tray, press button. The
sample tray and sectors definition window is displayed.

NOTE: Use Secondary to set a given sector for use with paediatric or Eppendorf vials,
press Primary to return to primary vial mode or press right mouse button on a given
position.

Use Data > Log as supervisor and then Maintenance > Parameters > Use to set the
secondary sample vial section before using this option.

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 To review a sample sector content, just point the mouse over the desired sector on
the tray. The complete list of samples will be displayed on the right panel.

 To review on-sector sample information, first click on a sector ID from the list of
sector or click on an on-tray sector. Then point the mouse over the desired sample
position on the actual sector, on the lower panel. The complete list of tests will be
displayed on the right panel.

Data are also available for printout in

Reports > Input Tray

Alternatively, assignment of samples to sector positions can also take place from the
sample programming window by clicking Place and choosing sector and position for the
highlighted sample on the right hand side list of samples. Click OK to confirm. Positions
can be reviewed and reports print out as described above.

6.3.7 Loading bar-coded samples

Be sure that sample bar code reading is enabled. Access for enabling is in

Maintenance > Parameters > Software > BCR (Supervisor only)

Once a sector is loaded, codes are read for all samples, if samples are not present,
reader will reach code located on the rear of sector which is equivalent to “sample is not
present”.

When Sample ID is recognized, vial position will match defined sample. If sample ID was
not defined in advance, new sample entry is created with recognized ID but user will have
to complete data.

If one or more codes are not read by the barcode or are not present, samples still can be
measured; a window will open containing the detected non coded samples and operator
can accept or reject them. Note that non barcoded samples have to be assigned at sector
positions before inserted to sample tray.

6.3.8 Loading non bar-coded samples, calibrators and controls

 To place a sample in a sector, first click in a sector ID from the list of sectors and
then press Place Sample . Choose from Samples, Calibrators or Controls tab at the top
and select the desired sample and sector position. Press Place to confirm selection, and
then repeat the operation or press Exit to return. Press Place All to fill all the free

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positions in sector with available samples in sequential order as indicated by sequence of

samples in the list and available positions in the sector.

To allow samples to be added or removed the sector must be out of the tray.
No samples can be added to or removed from an on-tray sector.

6.3.9 Removing a sample

 To remove samples from a sector (sector has to be out of sample tray), first click on
a sector ID from the list of sectors and then press Remove Sample. Select the sample
IDs or sector positions to remove. Press Ok when done or Cancel to abort.

To select more than one item from the list, press and hold Ctrl key while selecting the
new items. To select a range of items, select the first item, then press and hold Shift key
while selecting the last item. Alternatively, to extend the selection use the mouse to click
and drag.

Press Empty Sector if all samples should be removed from the particular sector.

Before using secondary sample option use Data > Log as supervisor and then
Maintenance > Parameters > Use to set the secondary sample vial section.

6.3.10 Placing a sector on the tray

 To place a sector on the tray, first click on a sector ID from the sectors list, then
press Place Sector.

 The sample tray drives the first available sector position to the sample sector
insertion/removal area.

 Remove the old sector if any, place the new one.

Place the sector in the specified area of the sample tray (defined by the two pins at the
edges of the sectors and when done press Ok button to confirm the operation.

Do not press OK before you have physically placed the sector in the sample
tray and have closed the sliding cover since the sample tray will start
moving immediately upon pressing the OK button.

If use of barcoded sectors is required, be sure that sample bar code reading is enabled.
Access for enabling is in

Maintenance > Parameters > Software (Supervisor only)

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6.3.11 Removing a sector

 To remove a sector from the tray, first click on the sector ID from the list of sectors or
click on an on-tray sector, and then press Remove Sector .

 The sample tray drives the selected sector position to the sample sector
insertion/removal area.

 Remove the sector.

To confirm the operation press Ok button when done.

Do not press OK before you have physically removed the sector from the
sample tray and have closed the sliding cover since the sample tray will
start moving immediately upon pressing the OK button.

Important: When sectors are coded for BCR reading, it is not necessary to declare the
sector number, user will be prompted to put any sector in the first available position. If
sector is not coded user must specify any non-used sector position.

6.3.12 Loading a STAT

All the STAT action is referred to a definition of one or more sectors with that condition.
Once defined, the STAT sector has priority over all other sectors.

For sector definition, select

Data > Log as supervisor and then Maintenance > Parameters > Sector definition

Define a new sector with a number and assign the STAT condition. Be sure that number is
not already defined in the column to the right. If so, first delete definition and then re-enter
new definition, including STAT condition.

Also an individual sample can be marked as STAT from the sample definition window.

6.3.13 Reports on load and use

From the menu bar, select Reports. The following menu can be seen:

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Input Tray: Data of samples introduced by operator or through LIS.

Reagents: Reagents and solutions already present in tray. Only those used by the
programmed samples are shown.

Method abstract: All methods already in memory are listed. Data include ID, name,
wavelengths, volumes and times. Methods are classified by type.

Units Conversion: A list with all the unit conversions that are currently being defined in
the system.

Reaction Tray: Cuvette status for all cuvettes in the tray. Data include condition, first empty
absorbance measurement and last reading.

On-line printing: When laser or ink-jet printers are used, samples are printed once batch
is ready. This option allows printing even if batch is incomplete.

Photometer calibration: Data from the last performed calibration.

Mechanical Calibration: Data on positions measured in steps for trays, arm, washers, etc.
Correspond to the last performed calibration.

Historic versions: Correspond to the history of versions for each method, as introduced
in their definitions. See section 7.1

Usage: defined for a programmed time interval. Information about Ran Tests and Used
Reagents is available. Option Used Bottles is reserved for reagent closed systems.

In all options, the Report Preview window is open. To print, press the corresponding icon
or select File > Print.

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6.4 Test results

To inspect, follow up and print sample results press button Window
showing results of sample tests classified by categories.
Press the corresponding button to access the desired category:

Press Pending tests to review non-processed (idle) or in-progress sample tests.

User must consider that test results may stay idle if the system operation runs out of reagent
or sample or the state of reaction is pending blank/pending calibration for a given method.
Check corresponding system messages.
Press Pending Acceptance results to confirm or reject processed tests that are waiting
for user's approval. During this operation relevant information such as actual readings,
absorbance against the time and blank measurement values will be provided.

Rerun option can be used to retry the reaction.

Test results under this category wait for user confirmation if the method's tests are set to
manual acceptance and/or the reaction is flagged.
Press External results to type in values from other sources, usually required by a
calculated method.

Press Calculated to check and confirm calculated method's results.

Press Done tests to review accepted and rejected results. Results can be filtered with the
patient’s last name, sample id and patient id by checking the corresponding box. Push
Details to review the reaction and potential comments of a given (highlighted) test. Data
can also be exported in a database format which can be further processed in Microsoft
Excel and other software programs. Additionally, select a particular result and press Reject
Test if a particular result or a repetition is not required to be printed out.

Results are also permanently stored. When Cumulative Historic button is pressed, the
following directory will appear:

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Data are stored in files, each one storing data corresponding to a month and a year. This
way results can be reviewed in a very simple manner and almost un unlimited storage
capacity is provided (only limited by the hard drive storage capability of the computer
used).

6.4.1 Acceptance of Results

To confirm the result for a given test use Pending acceptance, then select the desired
sample test from the list and then press Accept. Press Reject to reject the test result. To
re-process the reaction just press Duplicate or Diluted Duplicate if additional dilution
could be useful for confirmation of result. A dilution factor can be introduced at the pop up
window when selecting Diluted Duplicate or a confirmation window will appear if
Duplicate is pressed.

In order to accept or reject more than 1 result at the same time, you can use the shift and
control to select more than 1 result and push Accept or Reject.

6.4.2 Reflex Tests

Reflex tests are those automatically launched when a given test is out of determined
limits. Condition for the reflex test launch can be relative to fixed values or to a reference
class. Reflex tests can be defined from Methods > Reflex Tests.

6.4.3 Printout of results

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Results can be printed out in different ways and operator has full control on the way in
which results are shown. This is a Post Run operation and is not related to the On-line
printing controlled by Parameter/Software. Button Print opens the following selector:

Printing can be performed on all samples, filtered or selected. Selection can be made by
pressing Control Key while the pointer is pressed on selected samples. A range is
selected by pressing mouse on the first and then pressing Shift key and pointing to the
last one of the desired range.

There are three types of reports: continuous, samples are printed out one after the other;
3 per page according a fixed report format; custom, according report made by use of the
Report Format Generator, as explained in Tools > Modify Report.

6.4.4 Cuvette report

Press Cuvettes button in order to export all the details for a particular run, which includes
the measurements as well as reagent and sample volumes and detailed information on
steps that probes moved in order to aspirate constituents of particular reaction.

6.5 Calibration

To enter a new calibration or define a calibrator set, press button.

The calibration definition window is displayed showing different items as follows.

Press Calibration to order a new calibration over one or more methods.

Press Pending tests to review non-processed (idle) or in-progress calibration tests.

User should consider that test results may stay idle if the system operation runs out of
reagent or calibrator.
Press Pending Acceptance to confirm or reject processed calibration tests that are
waiting for user's approval. Re-run option can be used to retry the reaction and Detail
option can show the reaction measurements.
Test results under this category wait for user confirmation if method's calibration tests are
set for manual acceptance and/or the reaction is flagged.
Press In Use calibrations to review the actual method's calibration details.

Press Historic calibrations to review and use former method's calibration details. . Historic
calibrations can be used again. To do that, select the desired calibration and press the
Reuse button. The selected calibration will be shown in the screen of calibrations In Use .

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This resource must be cautiously used and prevent errors of calibrating with reagents of
different lots. Also, it should not be misused or mixed with other active calibrations.

Press ISE calibrations to access ion selective module calibrations. ISE calibrations are
automatic (conditions described at ISE chapter) but additional ones can be programmed
by user too, from Maintenance > Operations > ISE tab.

6.5.1 Calibrator Sets

Calibrations are structured by means of calibrator sets. A calibration set represents a

single or a cluster of methods that a commercial calibrator can be used for. Once user
defines all the necessary calibration sets, it's easy to order calibrations based on any of
them from Calibration tab.

Access to define new calibration sets and modify existing ones is restricted to the
simple user and only allowed to power user and supervisor.

6.5.2 Defining a calibrator set


 To edit the definition of an already defined calibrator set, first select the calibrator set
from the list on the right and then press Edit .

To enter or define a new calibrator set, press New. Assign a name for this calibration set
and the corresponding lot number of the standard. Furthermore, define the number of
vials this calibration set is using in case of multipoint calibrations or leave it default (1) in
case of single point calibrations.

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To add a new method to the calibrator set press Add Test and select or type in the
method ID. If a high standard is used and serial pre-dilutions are needed check the
automatic dilutions option and define the additional parameters as indicated below.

Type in the calibrator vial number and concentration, define the number of default
Replicas for each method and press Add. It is recommended to use 3 x replicas for each
calibration point in order to have better statistical precision.

Repeat this operation for each standard on the set. Press Ok when done or Cancel to
abort.

To remove a method from the calibrator set, press Delete Test.

Once no further modifications are required for the calibrator set, press Ok to finish
or Cancel to abort.

Once tests are loaded in the grid, concentration values can be edited at all times.

6.5.3 Removing a calibrator set

 To remove a calibrator set from the list, select the calibrator set from the list on the
right and press Delete. Press Yes to confirm or No to abort.

6.5.4 Automatic Dilutions

It is possible to build up a full set of calibrators as dilution from a high concentration

calibrator. When Add Test is pressed, the following screen will show up:

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The window for automatic Dilutions will show the number of dilutions that integrate the
curve. The Serial factor indicates the dilution factor: a factor of 2 will define the
concentration as 1/2, 1/4, 1/8, etc.; a factor of 3 will define concentrations as 1/3; 1/9;
1/27; etc. The set optionally can include or not the initial solution and the blank. If
included, they are within the defined number. The concentration of initial solution is
defined in the Vial sector. A minimum of 2 standards and a maximum of 10 standards are
accepted.

WARNING: The instrument will automatically adjust the number of times this procedure is
repeated for completing all requested standards and replicates.

6.5.5 Requesting a calibration

 To request a new calibration based on a calibrator set, press New and select or
type in the desired calibrator set from the list. Check at least one test you want the
calibration to take into account. Multiple tests can be checked at the same time if required
and all tests of the selected calibrator set can be automatically checked by pressing the
blue box at the left of the test label.

Press Ok when done or Cancel to abort.

To request at a later time another method from the calibrator set, select the calibration
from the list on the right and press Add Test. Check one or more tests you want to add

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and define the number of replicates. They can be equal or different for different tests.
Press Ok when done or Cancel to abort.

Additionally, from the historic calibration window, the operator can reuse an older
calibration.

6.5.6 Ordering a calibration

To load the calibrator's cups on the instrument sample tray refer to relevant section.

6.5.7 Calibration acceptance

 To confirm a calibration test result, press Pending acceptance and choose the
desired method.

It is possible to disable individual replicates by de-selecting from the calibrator column.

Column to the right of each function will show the least squares adjusting value. Select
function with minimum value unless some special feature is required. Experiment de-
selecting one or more standards and observe recalculated values. Press Accept once
the calibration curve and values are as desired. In this case, at least one value for each
vial must be selected.
Press Reject to mark the calibration as unusable.
In case that automatic acceptance criteria have been checked at the method application
section, the calibration will be accepted automatically if it falls within the defined
parameters.

6.5.8 Flagged results

Press Detail to expand the detailed area for the selected reaction. This panel points out
active flags. Results may be flagged if validity, duplication or reference class limits are
exceeded. Both low and high limits can be set independently.

6.5.9 Calculations

There are several built-in adjusting formulas in the system. They can be all shown if
available. They are:

Linear.

Multilinear: linear interpolation between consecutive standards.

Spline: consecutive 3d degree polynomials joining consecutive data.

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Sigmoid:

Abs = L + ((H – L)/(1 + exp(-(Conc – a)/b)))

where H, L , a and b are automatic adjusting parameters.

Logit5:

Abs = R + (K/(1 + exp(-(a+b*ln(Conc) + c* Conc))))

where K, a,b,c are automatic adjusting parameters.

Logit4:

Abs = R + (K/(1 + exp(-(a+b*ln(Conc)))))

where K, a,b are automatic adjusting parameters.

Calibration fit parameter is shown in all cases.

If curve is forced to pass through zero, functions logit 4 and logit 5 will diverge because of
the logarithm function and will not be shown.

Logit5 requires a minimum of 5 standards; logit4 requires a minimum of 4 standards;

sigmoid and multi linear functions require a minimum of 3 standards.

6.5.10 Automatic calibration

It is possible to define for each method, which Calibrator Set will be used in the
next calibration, once the present one is expired, deleted or changed the lot
number. This set can also be “Run in advance” and be ready several hours before the
present calibration expires.

By selecting Standards > Automatic Calibration the operator can select from the right
window the desired Method/Calibration Set combination. With the corresponding button
the run in advance interval is also fixed. This interval is checked every 15 minutes when
not in automatic mode and when software or automatic start.

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6.6 Blanks

Blanks can be measured in the automatic procedure or directly from

BLK
the BLANK menu.

When the automatic starts, blanks are requested for the following reasons:
a) It was not measured before or a new reagent lot was introduced
b) It expired
c) Reagent was removed, refilled or changed.
In that case, a window opens with the list of required blanks. User can include the
number of required replicates.
When button is pressed, there is access to the blank options.
When New is pressed, the following screen opens:

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Table shows last measured absorbance and its date. By checking and adding the number
of replicates, blanks can be measured.
The menu of blanks also shows the blanks Pending Acceptance. When replicates are
taken, operator can accept or reject them individually. Final result is the average of all
accepted values. In case that automatic acceptance criteria have been checked at the
method application section, the median value is used as the accepted value.

Blanks In Use can be observed and Historic results also analysed.

6.7 Quality control

The quality control system is based on the use of Control Sets. A control set is a vial of a
given brand and lot containing all the desired analytes with their respective admissible
ranges. Control sets from different brands and levels can be defined. Once the Control
Set is defined, it is used daily by defining a Control and selecting from the set the
desired analytes and number of replicates. New Control Sets must be defined when a
new lot is available and new admissible ranges are defined.

To request a new control or define a control set, press the button. The quality
control definition window is displayed showing different items as follows.

6.7.1 Creating a control set

Press the Control Set button.

To define a new control set, press New. Define Control Set Id, introduce lot
number and expiration date for traceability purposes and filtering options.

To edit the definition of a predefined control set press Control set and select the control
set from the list on the right and then press Edit .

To add a new test to the control set press Add Test and select or type in the method ID.
Then type in the concentration range for that method and press Ok to add the test or
Cancel to abort. To remove a method from the control set, press Delete Test.

Define the number of default Replicas for each test within each control set. This number
will be used every time the control set is used or scheduled.

Repeat this operation for each required test on the profile. Then press Ok to finish or
Cancel to abort.

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Alternatively, double click on the Quick load list to add tests in the control set and type
the values in the corresponding fields. Mean values are calculated automatically.

Once tests are loaded in the grid, concentration limits can be edited at all times.

To remove a control set from the list, first select the control profile from the list on the right
and then press Delete. Press Yes to confirm or No to abort.

Delete All button will remove all control sets.

6.7.2 Requesting a control

To request a control based on a control set, press Controls button and then New and
select the desired control set. Select at least one test to be performed and the number of
replicates. When double clicked on the Test title band, all tests can be selected or
deselected together. Replicates can be set individually or the whole set by performing
the selection on the title bar. Press Ok when done or Cancel to abort

Control Id is automatically generated by adding the date (day and month) to the Control
Set Id. This Id can be modified at the moment of generation but not at a later time.

New tests included in the Control Set can be added later: select the control from the list
on the right and press Add Test. Check one or more tests that you want to add. Press
Ok when done or Cancel to abort.

To remove a test from the control press Delete Test. Select one or more tests from the
list. Press Ok to confirm or Cancel to abort.

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6.7.3 Processing a control

Once the control has been requested, load it in a vial and place in the instrument as
indicated in 6.3.6.

If the barcode reading procedure is performed and a control set is recognized, it will be
associated with any pending action already defined in the scheduler. If not programmed
in scheduler, no action will be taken on the control.

Press Pending tests to review non-processed (idle) or in-progress control tests.

User must consider that test results may stay idle if the system operation runs out of
reagent or control sample.

Press Statistics to review the assigned and cumulative means for each test and some
statistical parameters as well as indication if any of the Westgard rules is being bridged.
Additionally, user can define which Westgard rules will be applicable to this window from
Maintenance > Parameters > Software > QC tab.

Press Done control tests to review former method's controls details.

Press Cumulative Historic to review data already stored in previous runs. They will be
organized in directories where results of each month are automatically stored.

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6.7.4 Processed controls. Statistics

Controls already processed are shown when pressing Done as shown below:
Use upper selector to set the filter properties with one or more of the following items:
Date: Index Test Id Lot Number Control Id Last
From: From:
To: To:

Date selectors show calendar for simple selection. All results are indexed and index is
shown at the beginning of each column. Selectors can be used separately or together.
Selectors act as logical AND which allows refining the selection.
When Details button is pressed, screen shows information about time evolution, interval
correlation, etc.

Additional Statistics can be applied to filtered data. Graphics indicate relevant statistical
data, Levy-Jennings diagram and Westgard rules violations. Data can also be printed out.
When Results button is pressed, the complete list of results is shown. Individual data can
be temporarily disabled for studies of effects of different data on the statistics.

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6.7.5 Twin QC

Twin QC operates on quality controls already performed and its purpose is relating
high and low controls and getting Youden plots and correlated Levy-Jennings plots.

Youden Plot is a bi-dimensional plot where correlated data for two-level systems or
normal/abnormal data, taken in the same run are represented.

For operation, proceed as follows:

1. Define a Twin set. Print the Twin definition button

a) Define a name which defines a given set of controls.

b) Select the prefix for the high and low (or normal/abnormal) levels. It is important that
they must coincide with the selections included in the Control Id column of Done
controls. In the example shown here: QB BIOS N1 and QB BIOS N2. The
identification after N1 and N2 is irrelevant.

2. Link the samples. Press Link Samples button. Window will show all controls which
correspond to high level in the second window and to low level in the third window.
Click the mouse on a high level item and next to the correlated low level item. Once
they are selected press the Link button. Press Statistics. Linked entries will appear
in the upper (Linked) window. For identification purposes entries will be shown in
alternate colours yellow and white. Every entry can be unlinked by selecting one of
both components and pressing the Unlink button.

IMPORTANT: Coupled quality control is a useful tool if both controls of each pair are
taken in similar conditions. Observe index number, date, time and lot number and
verify that data were taken in close conditions.

3. Select the desired method, and the initial and final date for the study.

4. Youden Plot. This statistical technique involves both normal and abnormal controls
and graphically helps to differentiate between systematic and random errors. The
square represents +/- 3 standard deviations for both controls. Red circle represents
SQR(SD12 + SD22) = 2. The two median lines (vertical and horizontal axis) represent
zero error normal and abnormal controls, respectively. The intersection of both
median lines is called the Manhattan Median. The diagonal through the Manhattan
Medial is the ideal location, high correlation position for the pairs. Points near the line
but outside the 2SD circle indicate a systematic error. Points that lie far from the 45-
degree reference line indicate a random error.

5. Levy-Jennings plot. This plot represents standard deviation data for both controls.
Also, several Westgard rules can be applied to both sets.

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6.7.6 QC scheduler
QC scheduler allows programming in advance all the QC actions on a weekly basis.

The defined controls are shown in the lower part of the screen. They must be dragged
and dropped in the desired hour and day and then saved by pressing the corresponding
button. They are immediately in the Pending QC status shown in red in the left side of the
screen. They can be removed by dragging and dropping on the trash symbol.
They remain as pending until they are in the list of programmed samples and all the
included reactions are processed. The Activity shows the next programmed action on
each control, but they are due immediately after programming. If only some test are
pending, warning flag will be in yellow colour.

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6.8 Working with LIS

The use of information management systems is in widespread use in hospitals and health
centres where data must be collected from different kinds of instruments. The LIS (or
LIMS) capability provides a reliable way for information interchange through ASTM E1381
and E1394 standards.

Results from accepted tests may be transmitted automatically to the host computer by the
analyser software, upon request from the host computer or manually at any time at user
demand.

Refer to the LIS integration guide for more information.

6.8.1 Parameters
Maintenance > Parameters > LIMS

Auto send results. The results are send to the LIS when a test is manually or automatically
accepted.

Only order by LIS. Only sends results from tests required by the LIS system. Manually
programmed tests are not sent.
Auto request tests. When a new sample is created, a query to the LIS system is generated
in order to obtain the test for that specific sample. A sample can be created manually from
the sample window or by the bar code reader. If the BCR reads a sample that already exists
the query is not generated because it is supposed to be generated at time of creation. This
same query will be send to the LIS if you push "LIS req." button in the sample window.
Send QC results. If the software should send QC results to the LIS system.
Send calibrator results. If the software should send calibrator results to the LIS system.
Apply method limits. If the software should take in consideration the high and low method
limits in order to transmit the results. If checked, and the result is outside limits, the value
> X or < Y be sent.
Port number. Serial communication port number used by the LIMS interface.
Baud rate. Serial communication port baud rate used by the LIMS interface.
Parity. Serial communication port parity used by the LIMS interface.
Query time out. When the equipment software sent a query to the LIMS system, an answer
should be received before the query time out expired. The query will be sent up to 3 times.
Retry wait time. If an error occurs during a message transmission, the software will wait
this time before trying to resent the message.

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Time between messages. The equipment software will wait this time from the last
transmitted or received message in order to send a message to the LIMS system.
Translation. Synonyms for patient and sample type between LIMS system and the
equipment software.
Coding. If the software and LIMS system are running in Windows Systems with the same
code page, Windows default should be selected, otherwise, any of the Unicode codes
should be selected.
The software also allows the answering of queries from the LIS system in order to obtain
results.
How query mode works and what to do in order to work with it.
You should first try to establish communication with the LIS system. Uncheck "Auto request
test" option and apply changes.
Go to Data->LIMS->Communication and erase any previous log. Then, from the sample
window, create a new sample and push "LIS req." button. Go back to the LIS
communication window and you will see the {ENQ}. The same way the software works
when the "Auto request test" option is selected, except that there is no need to push the
button. You can now check this option, create a new sample and you will observe the same
behaviour.

6.9 Definition and use of sample profiles

Sample profiles are useful for ordering pre-defined patterns of tests.

6.9.1 Defining a sample profile

Select in Menu Methods / Profiles. Profiles definition window is displayed.

To edit the definition of a pre-defined sample profile, first select the sample profile from the
list on the right and then press Edit .

To enter or define a new sample profile, press New .

To add a new test to the sample profile press Add Test and select or type in the method
ID. Then type in the number of replicates for that method, and press Ok to add the test
or Cancel to abort. To remove a method from the sample profile press Delete Test .

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Repeat this operation for each required test on the profile. Then press Ok to finish
or Cancel to abort.

6.9.2 Removing a sample profile

 To remove a sample profile from the list, first select the sample profile from the list on
the right and then press Delete.

Press Yes to confirm or No to abort.

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7 Definition of methods
There are four major types of methods or procedures in clinical chemistry analysis.
Photometric method definitions include the volumes of reagent and sample, the times
when the absorbance measurements must be taken by the photometer and the
calculations to obtain the final result. ISE methods define the ion selective electrode
measurements only. Calculated and external methods are used to compute a new result
with the results of other methods and/or externally added values.

7.1 Management

To work with methods press button

The method definition window is displayed where you can choose different
method categories and options on the left, and the corresponding methods list on the
right.

The method type defines the general behaviour of the method. Reaction or photometric
types include End Point , Fixed Point and Kinetic ; definition of selective electrode
measurements through ISE ; relate other methods results using a formula
through Calculated ; and added External measurements.

The Options and Solutions category allow managing several lists as detailed later on.

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Use Solutions to define and specify kind (cleaning or diluents) of user solutions and set
the BCR code.

7.1.1 Creating or editing a method

To edit a method already defined, first select the corresponding type, then select the
method ID from the list on the right and finally press Edit button.

To create a new method test, first select the corresponding category, and then press
New on the bottom of the screen.

7.1.2 Erasing a method

To erase a method, first select the corresponding type, then select the method ID from
the list on the right and finally press Delete button. Press Yes to confirm or No to abort.

7.2 Method parameters

Several sections can be accessed in the method definition window.

7.2.1 Common parameters

The method ID is unique and the first 3 characters are used at quick load tables and for
identification of reagents. Therefore, replicates are not allowed because it unequivocally
identifies the method. Letters (A-Z, a-z) and number digits (0-9) can be used as well as
hyphen signs (- and _), however avoid using other delimiters, punctuation signs and
spaces. The Name is used in reports and a complete description of the method ID can be
written. The units indicate the measuring units of the result (quantity, concentration,
activity, time, percentage, etc.). Available units can be loaded in the Options menu. The
number of decimals defines the decimal representation of results. Sample type defines
the nature of the sample (Serum, Plasma, Urine, CSF, Dialysate or Other).

The BCR code identifies reagent as defined by manufacturer. It could eventually coincide
with the method ID.

Version allows user or reagent manufacturer to keep control of the method release
version.

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7.2.2 Main Page

These general parameters are applicable for all photometric/colorimetric reactions.

Others are specific to the reaction type.

Wavelength. Main and dichromatic reference. They are shown in drop down menus.
Values are taken from the information stored in the instrument itself and according to the
installed filter set.

Delivery/Volumes. Up to three reagents can be programmed. If more than one reagent

is programmed dispensing times defined after sample delivery can be added.

Time. Indicates delay after the addition of the first reagent. If sample delivery time is set
to zero, it is delivered with the first reagent. For a 2-reagent method, both reagents can
be delivered simultaneously (second reagent time equal zero) or at different times. When
the sample is delayed, the system will take reagent already delivered and then aspirate
sample ensuring all the sample will be eluted by reagent.

Then it is possible to pre-incubate reagents in the tray and then start the reaction by the
addition of sample.

Readings. Reading time is counted after the addition of the last liquid (reagent or
sample). In the case of kinetic tests, incubation starts with the addition of last liquid and
the reaction time after the incubation.

Dispense with ...Extra volume. Each reagent can be aspirated either with additional
reagent or with water. The extra reagent is discarded. Its use is recommended when
carryover must be avoided. An extra volume of 10 to 15% may be useful. N.B. If extra
water is used, it incorporates some water to the reaction. This is used when additional
water does not interfere with the reaction but it ensures that the water carryover is similar
in all samples.

Sample Diluents. The sample will be pre-diluted in two different scenarios: if

programmed into the method or if the result is above some specified limits. In both cases
the user, in advance, must define how the dilution will be processed. There are several
possibilities: a) washing water, b) reagent, c) specific diluents. If the reagent option is
chosen, a drop down menu will include all reagents in method (1, 2 or 3). If specific
diluents option is used, the menu will include all entries included in the Solutions as
diluents.

Pre-dilution. Specific methods, mainly turbidimetric, require sample dilution in one of the
above specified forms. Dilution is understood as 1 in the factor value That is, a factor of
20 means one part of sample and 19 parts of diluent. If checked, controls and calibrators
will be treated with the same condition

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7.2.3 Specific data.

End point

Readings. Measuring time starts when the last reagent was added if more than one or
when sample was added if only one reagent is used. When Extra Precision is used
(recommended), two consecutive readings are averaged.

Fixed Point
Readings. Incubation is the time interval between addition of last reagent and the first
reading. Reaction time is the time interval between two readings. When Extra Precision
is used (recommended), each value is the linear interpolation of two readings, one before
and one after the specified time.

Kinetics
Readings. Incubation is the time interval between addition of last reagent and the first
reading. Reaction time is the time interval in which 7 readings are performed. These 7
readings define the slope for the concentration calculation (in some cases, only 6 points
are considered).

7.2.4 Quantitative

In Calibration type we have two options: fixed Factor methods where factor is provided
by manufacturer at a given temperature or Curve/Linear where an operator uses one or
more standards for calibration. The definition of a calibration curve is made in calibration
screen, Calibrator Setting > Add Test option. The Fixed point option determines the
number of points used in calibration If this option is not selected, the user can define a
calibrator set with any number of points. The Mandatory Formula defines the type of
calibration and it cannot be modified in the acceptance screen.

Calibration can be also taken from another method by selecting Use from this method
and selecting a desired one from listing in the pull down menu. This feature is useful, for
instance, to measure serum and urine with the same calibration. Respective pre-dilution
factors are taken into account in each case.

The Validity time will indicate when calibration must be renewed, unless lot is modified.
Samples will be pending of calibration until new calibration is performed. Blanks are also
erased. A 0 value will leave this option unused.

Unit conversion. Includes a bias and a factor (linear transformation parameters) required
to transform units between different systems.

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Method Correlation. Includes a slope and an offset (linear transformation parameters)

required to transform units between different systems and match correlations if required.

Direction. Ascending or descending according to method. If Direction check is enabled,

flagged results will require manual acceptance.

Blank. All methods have an option for measurement of a reagent blank. If method uses
more than one reagent, blanking is made with a reagent mixture similar to that used in the
method. For better accuracy, sample is replaced with a specific diluent, taken from the
Solutions (see Error! Reference source not found.) or with Reagent.
In both cases the Extra Volume option is available.

The number of replicates can be defined on the screen of blanks but can also be included
here as part of the method. Its default value is 1.

Blanks have a validity time defined in the method. New blank will be requested if validity
time is expired or if reagent lot number if modified. In fact, the instrument will store a
different blank for each reagent lot number in use. The blank will be automatically
performed when the reagent bottle in use is substituted without operator’s intervention
when another is already in the tray (See 6.6).

For End Point methods, the Reagent and Cuvette Blank can be applied. In this case,
reagent is delivered into the reaction cuvette, measured, sipped again and if required,
delivered in the same cuvette together with sample and additional reagent. This procedure
will increase precision but will take some extra time.

7.2.5 Limits

Concentration validity limits can be used to automatically re-run reactions outside the
limits. A pre-diluted sample or with lower sample volume re-run can be ordered for high
value samples. The pre-dilution accounts for high and low limits and calculates the dilution
factor as to put reading approximately in the midpoint.

If the low limit is not reached, the More Sample choice will produce an automatic repetition
with more sample volume to produce results within the method limits. Low and high validity
limits are the lowest and highest values that the method can determine. Calculations are
adjusted to produce true results.

Integrity check absorbance limits are used in the integrity check procedure to validate
quality of reagents in use. Low and high limits may be enabled or disabled.

Concentration Duplication limits are used to verify a result outside the stipulated limits.
This limit is independent from the method reference value and can be used to define

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repetitions according to the needs of each laboratory. For instance, laboratories working
for an insurance company could establish to duplicate every analysis with Glucose higher
than 140 mg/dl.

7.2.6 Reference classes

Reference classes define the normal limits or reference values for the various types of
samples: men, women, children, etc.

Reference classes may be added to the method definition using particular low and high
limits. Reference classes are used for analysis flagging and reports. The reference
classes are introduced in the Options. To introduce an already defined reference class in
the method, press the Add button. Additionally, if the Qualitative Result option is
enabled a result can be reported as positive or negative instead of a numerical value.

7.2.7 Advanced features

Advanced features include pre and post additional probe washes, manual or automatic
acceptance of samples, interfering methods, intensity of mixing, and on-board stability of
reagents. Tip Post-wash. This is used when a reagent, which may interfere with or
contaminate other reagents or the system, is in use. It can be performed either with water
or with a specific solution defined in Solutions (see Error! Reference source not found.).

Tip Pre-wash for interference. When a reagent is known to interfere with another, a
probe pre-wash can be performed using wash water or a solution as defined in the
Solutions (see Error! Reference source not found.) or by the reagent itself.

This action can be performed Always or only after any of the listed interfering reagents.
To define interfering reagents with other reagents on-board, press the button Add and
select from the list of all methods stored in memory.

Sample Acceptance.

Once samples have been processed, they can be automatically sent to the Done section
of results without requiring operator’s decision/validation. This option can be programmed
method by method. When test is flagged, acceptance will become manual even if
programmed as automatic. Shake (mixer). The probe motor is activated when the tip is
immersed in the reaction cuvette. Shaking period may be adjusted to Normal, X2, X3 or
suspended. Shake is performed on tip cleaning, intermediate wash, reaction cuvette and
pre-dilution mixing. Normal (centrifugal) mixing duration is 500 msec.

Viscous Reagent. In case that one or all of the reagents that a method is using, are
having a sticky consistency, the viscous reagent option can be checked in order to slow
down the dilutor speed and ensure better aspirating and dispensing precision.

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On board stability. Once a reagent is placed in tray or re-filled, when the period is
expired, the reagent must be removed from tray. If the Keep Using option is enabled,
only a warning will be issued.

Cuvette post-wash. Before new use, cuvettes used by the method can be washed with a
decontaminant solution. Decontaminant solution is defined in the Options menu. The
typical application is the washing of cuvettes with NaOH when using with latex methods.

After sample tip wash. After sample intake, if this option is enabled, it causes the tip to
be washed before delivery in the reaction cuvette. This feature will improve linearity in
methods with very low absorbances.

Interfering methods. Methods interfering can be including in the list. The system will
prevent the delivery of an interfering method immediately before or prevent delivery in the
cuvette where the interfering method was delivered in the previous tray turn.

7.2.8 Consumption

This section applies to kinetic methods only.

Consumption check. Each kinetic method requires a consumption check before

measurement during the incubation period. Its purpose is to prevent false negative results
due to excessive initial consumption. The consumption limit value is in general
determined by manufacturer’s recommendation. Method includes options on how the
measuring interval is defined.

If the first and second point option is selected, evaluation is performed when measuring
starts and between the first two measuring points out of the 10 readings performed in
every kinetic measurement. In the time and first point option, measurement is taken
before measurement sequence. The interval is defined in time before first. The second
option is recommended at 15 seconds for method incubations below 60 seconds and 30
seconds for method incubations above 60 seconds.

Behaviour. With conservative behaviour, the instrument will perform 7 readings evenly
spaced along the Reaction Time. In the adaptive option, the instrument will “learn” from
the values read during the incubation period and will stretch or enlarge measuring period
and intervals. This optimizes the precision of the analysis if the consumption is low by
increasing the total reaction time and the interval between readings. If consumption rate
is high, total the reading interval will be shortened to preserve linearity. This second
option is recommended.

Initial absorbance limit. If consumption is so high that all substrate is consumed before
the first reading, criteria based on initial absorbance limit can be applied. If absorbance is

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below limit in descending reactions or above limit in ascending reactions, the sample will
be pre-diluted.

Examples: if an ALT kinetic assay (descending reaction) produces a value below 0,600, it
means that absorbance diminished from about 1,700 to < 0,600 during the incubation
period.

If ALP first reading is above 0,800 all substrate has been consumed during the incubation
period. In both examples the prerequisite is that the reagents have previously passed the
integrity check and are in good working condition.

It is recommended to follow reagent manufacturer directions at all times.

7.2.9 Reagent substitution

If two or more methods can share the same reagent, it is convenient to substitute with a
single vial. Example: IgA and IgM methods of the same brand share the same buffer or
first reagent. First define the Turbidimetric Buffer as Diluent (Use Method Definition >
Solutions > New > Diluent) ; next, introduce in IgA and IgM methods, in the substitution
page the “Turbidimetric Buffer” and check “1st Reagent”.

Additionally, this feature is very useful for different sample types. E.g. serum calcium and
urine calcium are performed from the same reagent but results have different
concentration levels and often a high predilution factor is applied for urine methods. With
reagent substitution option urine and serum types can be measured from a single reagent
vial.

7.3 Coagulation methods

Coagulation is measured by the change of absorbance with time produced by clot

turbidity.

Absorbance is measured in short time intervals. The time period in which the change in
absorbance occurs is measured in seconds.

In single reagent methods, measurement starts after the sample-reagent mixing and ends
either when the absorbance reaches the threshold (successful reading) or when the wait
interval is surpassed (clot not formed).

In two-reagent methods, the measurements start after the addition of second reagent.
The second reagent time is the interval between the initial delivery and the second
reagent addition.

If coagulation methods are set, cuvettes used cannot be automatically washed and are
changed manually at the end of the run.

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7.3.1 Main page

Heading is similar to that described for all other methods. Units must be set in seconds if
individual values are required and in percent of normal value if a calibration curve is built.

Wavelength: Principal is usually set at 405 nm unless another value is recommended by

reagent manufacturer.

Side: Not used.

Readings. Wait (sec): Maximum waiting time if clot is not formed and threshold not
reached. Measured in seconds. When elapsed, procedure continues with next sample,
even if the threshold was not reached.

Threshold (Abs): Absorbance level that indicates coagulation. For most reagents,
optimum range is between 0,020 and 0,100

Delivery Volumes: according to method.

Sample: Any up to 100 microliters.

First reagent: up to 500 μL. Total reaction volume cannot exceed.

Second reagent: Instrument permits methods with two reagents, for time elapsed
methods.

The two reagents can be dispensed simultaneously or separately. Two parameters

control the use of double reagents: 2nd Reagent and 2nd incubation time.

2nd Reagent. If 2nd volume is zero, method is single reagent. If 2nd volume is greater than
zero, it is two reagent.

2nd Incubation Time. When this is zero, the sample probe aspirates the first reagent,
then the second reagent and then the sample.

On the contrary, if the 2nd incubation time differs from zero; the first incubation time will be
the time elapsed between dispensing of sample and 1st reagent, and dispensing of 2nd
reagent. The second incubation time is the time elapsed since dispensing of second
reagent and reading.

Dispense with reagent or diluent option is available and predilution which are not often
applicable. Quantitative

Method Correlation. Slope (multiplying all data with a factor and offset (adding a
constant value) can be applied. Setting up these values allows modifying results to
correlate with other instruments.

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Base Line. Minimum: When this item is enabled, threshold is measured from the
minimum measured absorbance. If not enabled, reference is set to the initial absorbance
(First point). This feature is useful because some reagents reduce turbidity after few
seconds.

Variable threshold. Threshold can be variable with time, starting at a given initial value
and linearly reducing its value to a given percent of original threshold. From (sec.): Initial
time from which threshold can linearly decrease with time. To: (% of threshold): This
parameter indicates the % of initial threshold when the wait time expires. If no variable
threshold is desired, this parameter should be set to 100%.

Calibration type. With fixed factor of 1, data can be measured in seconds.

Calibration curve in coagulation must be set in percent of normal sample, pool or control.
It is useful to establish dilutions, which represent some points between 100% and 10%.
The number of dilutions can be up to 10 but normally 4 points is enough to define a
coagulation curve.

It is useful also to utilize the automatic dilution feature. By using a dilution ratio of 2, 4
points and inclusion of 100% (0 should not be included), the curve will be built with 100%,
50%, 25% and 12.5%. Sigmoid, logit or linear equations will result. Selection of equation
with best fit (minimum least squares summation) is mandatory.

7.4 Solutions and Options

There are two important data sets that are introduced as Options:

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Measurement units: units can be defined by operator but usually most used units are
already factory defined.

Reference classes: listing of all categories for which normal reference values can be
defined (male, female, child, etc.).

To add new reference class, press Add in the corresponding set, write category and
then press OK to confirm or Cancel to abort.

To remove a reference class, simply click on them and press Delete. No confirmation is
required. Nevertheless, when clicking on component, a window asking Set as default?
will display. If answer is No, you can proceed to delete it.

If the answer is Yes, this reference class is set as default and when a new sample is
programmed and the reference class not edited, it ll be set on the default. In Solutions
there are two categories- Fixed in the system and user defined.

The Fixed Solutions are those for probe wash and rinsing, ISE cleaning and ISE urine
dilution. They cannot be deleted or modified but require operator’s action for placing in
the tray. Barcodes can be attached to them to facilitate ease of use.

Cleaning solutions: additional cleaning solutions for several methods.

Diluents: generic and specific diluents required in some methods (physiological solution,
distilled water, etc.).

To add components, press Add button, define category and barcode identifier, if any. To
confirm, press OK or Cancel to abort.

7.5 Calculated methods.

Method ID, name, units, decimals, and external name are introduced as in any other
method.

Formulas are calculated with methods previously stored in the memory.

The Add button allows introduction of methods in the formula bar. Methods IDs, used as
variables, are linked with common mathematical operators: +, - , * / , (), etc. Button Test
Formula will check the formula’s consistency.

Methods show formula surrounded by symbols > and <.

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External methods can be used in formula if previously stored in memory.

Methods may correspond to different samples if samples are assigned to the same
patient. Reference classes are defined in the method screen and have no relation to
categories defined in the Options.

7.6 External Methods

External methods are printed out together with those calculated by the instrument.

These are useful for the introduction of constants in the calculated methods. Such
constants are, for instance “Creatinine clearance”, “24-hour volume”, etc.

Method ID, name, units, decimals, external names are introduced as usual.

Reference classes are defined in the method screen and have no relation to categories
defined in the Options.

ISE Methods will be covered extensively at following chapter and are not
presented in this section.

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7.7 Units and Limits.

Units and limits can be modified from the menu of methods without direct access to a
given method in particular. This feature is very useful when operating in closed reagent
systems since user can only modify limited parameters to existing reagent applications
and are all presented at this window.

In brief, the method id and measuring units can be modified. Method correlation,
concentration duplication limits and reagent blank and calibration automatic acceptance
limits can be set. Reference classes can be modified, deleted or added. Additionally
sample acceptance can be assigned as manual or automatic and on board stability can
be extended by checking the Keep Using button.

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7.8 Units conversion

This conversion table is only accessible to the service level and can be reached by
Methods > Units conversion
This window is mainly separated into two sections; the universal conversion units on the
top and to method specific ones at the lower part. Make sure that all units needed for
reporting purposes are created at Options window as described previously. Choose from
one unit to another, apply the correct factor and click Add to create the new pair. In the
method specific section, first highlight the desired method and then continue as above.
Any change in the units will include automatic modifications in below parameters:
Calibration factor, redefined.
Concentration validity limits
Concentration duplication limits.
Factor of automatic acceptance
Reference classes
Calibrator sets
Control sets.
Additionally, tables with unit conversions can be imported from another system. The table
of conversion can be imported through
Data > Import > Units Conversion
A report is generated with the conversion table and is accessible from
Reports > Units conversion

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7.9 Development of a Method

The option Methods > Development gives access to review in real time any reaction.
This method does not run with others as part of the automatic cycle. It is used alone,
sample by sample and its purpose is to study slope, end point, optimum range, incubation
period, etc. of individual reactions.

In Options, basic method parameters are defined: wavelengths, number of reagents,

volumes, total measuring time. In Calibration page, analysis type is defined and fit
formula calculated. In Results, measurements can be viewed graphically and Time 1 and
Time 2 can be adjusted in order to focus on required time interval. This function is mostly
used for research and development projects as well as method optimization

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8 ISE module
8.1 ISE MEDICA Module

WARNING:
Never leave the Module without a pack or connected to an empty one.

Cleaning solution should always be on tray.

Follow the maintenance schedule.

8.1.1 Overview

MEDICA ISE Module includes ion-selective electrodes and three peristaltic pumps. The
ISE module measures the concentration of Li+, Na+, K+, and Cl- in serum, plasma and
diluted urine. An integral sample entry port is positioned on top of the ISE Module, where
the instrument probe dispenses the sample. This compact design allows for small sample
size and fast operation.

The ISE Module houses snap-in, snap-out electrodes which connect directly to an
electronic board within the ISE Module. This eliminates the need for cables and
minimizes electrical noise. Samples and calibrators are positioned in front of the
electrodes by three peristaltic pumps. Two separate pumps move Calibrant A and
Calibrant B into the ISE Module’s sample entry port and a waste pump positions samples
and calibrants in front of the electrodes. The sample is deposited by the analyser probe

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into the sample entry port. After each sample measurement, a calibrant is positioned in
front of the electrodes for a single-point calibration. The removal of protein build-up on the
electrodes and fluid path is accomplished by the use of cleaning solution. Cleaning
solution is placed in a reagent position on the analyser sample tray, aspirated, and
deposited into the sample entry port by the analyser probe.

8.1.2 Electrodes

Electrodes are maintenance-free. Electrode packages are marked with an “Install-by

date.” Cleaning solution, aspirated from the analyser reagent position, will be required
every time that the software is open, after a measuring cycle and every 50 samples, to
minimize protein build-up in the fluid lines and electrodes. A pump calibration is
performed each day. A two-point calibration is performed every 8 hours, and after
electrode cleaning. To ensure reliable operation, the ISE Module sips calibrant every 30
minutes, beginning after the last sample is run. This function is completely controlled by
the ISE Module.

The ISE Module utilizes a double-junction reference electrode. The reference electrode is
filled with saturated KCl. If the concentration of the reference electrode reservoir drops
below 3.0M KCl, serious errors will result in the measured electrolyte concentrations. The
reference electrode contains a small red sphere in the reservoir which normally resides
on top of the filling solution. If the sphere begins to sink, the reference electrode must be
replaced. When measuring urine, the sample will be automatically diluted by the
instrument (1:10 with MEDICA urine diluent).

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8.1.3 Fluid Management

The sample is aspirated by the probe from a sample cup and dispensed into the sample
entry port on top of the ISE Module. The sample is then positioned in front of the
electrodes for measurement. Four solutions are required to operate the ISE Module.

8.1.4 Calibrant A

Used in both two-point and single-point calibrations for serum sample analysis. Calibrant
A is pumped into the sample entry port by the Calibrant A pump and then positioned in
front of the electrodes by the waste pump. Calibrant A solution is also used for Pump and
Bubble Calibration.

Calibrant A Solution

Li+ 1.0 mmol/L

Na+ 140 mmol/L

K+ 4.0 mmol/L

Cl- 125 mmol/L

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8.1.5 Calibrant B

Used in two-point and single-point calibrations for urine sample analysis. Calibrant B is
pumped into the sample entry port by the Calibrant B pump and then positioned in front of
the electrodes by the waste pump.

Calibrant B Solution

Li+ 0.4 mmol/L

Na+ 70 mmol/L

K+ 8.0 mmol/L

Cl- 41 mmol/L

8.1.6 Cleaning Solution

Is required every time that the software is open, after a measuring cycle and every 50
samples, to minimize protein build-up in the fluid lines and electrodes. It must be used
more frequently if the ISE Module performs more than 50 sample measurements per day.
100 μL of cleaning solution is aspirated by the analyser from a reagent position and
dispensed into the sample entry port. The cleaning solution in the reagent container must
be covered to eliminate evaporation.

NOTE: Medica pepsin/HCl cleaning solution must be prepared every four weeks and
stored at 4º C.

8.1.7 MEDICA Urine Diluent.

Urine samples are automatically diluted to perform urine measurements 1:10 with
MEDICA urine diluent.

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8.1.8 Test Ranges

Analyte Units Test Range Min. Test Range Max.

(Whole blood, serum, plasma)

Li+ mmol/L 0.20 3.50

Na+ mmol/L 100.0 200.0

K+ mmol/L 1.00 10.00

Cl- mmol/L 50.0 150

(Urine)

Na+ mmol/L 10 500

K+ mmol/L 5 200

Cl- mmol/L 15 400

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8.1.9 ISE Pack installation

The new ISE Pack is provided

as shown.

Remove the pack from the

outer box.

Identify the connection caps.

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Remove the caps from the

connections. On reagent pack
replacement, the rubber caps
can be used to cap the
container prior to disposal.

From Maintenance >

Operations > ISE push
Change reagent Pack. Wait
until the pop up window is
shown.

Gently push the tubing

terminal until it clamps to the
pack.

Push Ok on the pop up window

and wait until operation finish.

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8.1.10 ISE Pack Removal

From Maintenance >

Operations > ISE push
Maintenance.
This command disables the
automatic wet. Never leave the
Module in this status with the
reference electrode in place for
more than an hour after an
Empty cycle is initiated, as KCl
will diffuse out of the reference
electrode. Over time, the KCl
will clog the flow path.

Press the yellow button on top

of the tubing connector and pull
gently.

8.1.11 MEDICA Operational Parameters

Maintenance > Service > Parameters > Instrumental > ISE.

ISE parameters must be set in order to ensure a proper operation.

Parameter Value
Urine Diluent Factor 10
Prime Idle Time (minutes) 20
Prime Repetitions 1
Serum volume (ul) 100
Urine volume (ul) 10
Extra volume (ul) 50
Air Gap 100

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8.1.12 Maintenance

The ISE Module has been designed to require very little operator maintenance. The only
daily maintenance required is to run the cleaning solution after the last sample of the day
or after 50 patient samples (automatically done), whichever is first, will be automatically
required by the software. Clean the sample inlet port with a cotton swab and DI water
once per week. All other parts and consumables are replacement items (see schedule
below). Use only MEDICA approved components.

Recommended Component Replacement Schedule (low volume user)

Li+ Electrode 6 months

Pump Tubing 6 months

Na+ Electrode 6 months

K+ Electrode 6 months

Cl- Electrode 6 months

Reference Electrode 6 months

Fluidic Tubing 12 months

Recommended Replacement Schedule (high volume user, ≥100 samples/day)

Li+ Electrode 3,000 samples

Pump Tubing 6 months

Na+ Electrode 10,000 samples

K+ Electrode 10,000 samples

Cl- Electrode 10,000 samples

Reference Electrode 10,000 samples

Fluidic Tubing 12 months

8.1.13 Preparing the ISE Module for Storage

If a laboratory plans to store the Instrument or discontinue the use of the module for a
period, the following steps should be performed with the ISE Module. Prior to removing
the electrodes, they should be cleaned using the cleaning solution and then 3x Purge A
cycles should be run. Then, from Maintenance > Operations > ISE, push Maintenance
to purge the ISE Module fluid path.

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Reference, Na+, Cl- electrodes

• Depress the compression plate and remove all electrodes, including the reference
electrode from the ISE Module.

• Place the Na+ and Cl- electrodes into individual sealed bags.

• Re-insert the yellow flag into the reference electrode flow path line, if available. Then
put the electrode into individual sealed bag.

K+ and Li+ electrodes

• Aspirate a small volume of Calibrant A from the top port of the reagent pack into a
syringe fitted with a blunt needle.

• Inject sufficient Calibrant A into the lumen of the K+ and Li+ electrodes until fluid fills
the lumen.

• Cover both ends of the lumen (both sides of the K+ and Li+ electrodes) with tape to
hold the Calibrant A in place.

• Insert the K+ and Li+ electrodes into a sealed bag.

Reagent Pack

• Remove the reagent pack from the analyser and discard.

Analyser Tubing

• Remove all fluidic tubing and thoroughly rinse with DI water.

ISE Module re-activation

• Remove all electrodes from sealed bags.

• Remove tape from K+ and Li+ electrode.

• If necessary, soak the reference electrode in warm water until the lumen of the
electrode has been cleared of salt build-up.

• Install electrodes into the ISE Module.

• Connect new reagent pack to the ISE Module.

• Use Prime Cycles to prime the calibrants.

• Use Electrodes Calibration command to start operation.

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8.1.14 Troubleshooting

To enhance trouble-free operation of the ISE Module, it is important to follow the

recommended component replacement schedule listed in the maintenance section of this
manual.

When the ISE Module is not operating properly, approach troubleshooting as a logical
sequence of events. Isolate the problem area to avoid unnecessary component
replacement and down time.
Troubleshooting can be categorized into three main areas. These areas are:
 Fluid delivery,
 Electrode stability,
 Communication Errors.

Troubleshooting should focus primarily on fluid delivery and electrode stability. As these
are related, sometimes the same symptoms can have different causes.
All problems can be corrected while the ISE Module is still installed in the analyser.

Communication Errors

System Does Not Respond

1. Make sure that power is reaching the ISE Module. With the power turned on, you
should be able to read 24VDC between T1 and T2 on the Interface Cable Assembly.
You should also be able to read 24VDC between pins 27 and 29, or 28 and 30 on the
main connector where the Interface Cable Assembly is connected to the ISE Module
main PCD.

2. Turn off power to the ISE Module and re-apply the power.

3. Check the RS232 cable for damage. Replace the Interface Cable Assembly, if
necessary.

Fluid Delivery

The instrument performs a Pump Calibration cycle every time that the ISE module is
initialized, after opening the software. This cycle will calibrate the pumps that dispense
Cal A and Cal B, and position fluid in front of the electrodes. The waste pump moves
solution from the Sample Entry port to the electrode area for measurement. As the tubing
ages and samples are passed through the system, the positioning of the solution will
change. The pump uses a stepper motor that counts how many steps it takes to move the
solution to the correct position.

By calibrating the pump each day, the ISE Module can now calculate the relationship
between volumes and pump steps. This will enable the pumps to dispense an accurate

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volume of calibrant and for the solution to be accurately placed in the proper location for
analysis.

Problems can be caused by a partial obstruction from a clot in the tubing from the exit
tube to the waste pump, a sharp bend in the waste tubing that restricts the flow, or a
misalignment of the electrodes. As the pump tries to pull the fluid from the sample entry
port into the electrodes, a vacuum develops because of the restriction. The bubble
detector detects the trailing edge of the solution (sample, calibrant, etc.) and stops the
waste pump so that the solution is in front of the electrodes. The vacuum will cause the
solution to travel after the pump stops.

One of the first indications of a flow problem will be the lithium electrode response.

If, however, the solution slowly moves out of the electrodes when the pump has not been
activated, there is either a leak between the electrodes, or along the flow path. This can
be tested by placing solution into the sample entry port by hand and watch to see if the
fluid level changes. In either case, the symptoms would be similar—the lithium or sodium
millivolts would experience noise errors and the bubble detector would trigger an error. G

Electrode Stability

Errors associated with electrode instability typically include drift, noise, and slope failures.
While these errors may be caused by a failure of a particular electrode, it is necessary to
explore other causes as well. Proper operation on a daily basis is the key to keeping the
electrodes stable and the system working properly. Each day, it is necessary to perform a
Cleaning Cycle. The cleaning solution removes protein build-up in the flow paths of both
the electrodes and the tubing. In high sample volume instances, it may be necessary to
perform this cycle more than once in a single day. The instrument will automatically
require the cleaning solution after every sample reading batch.

It is also necessary to replace the Reference Electrode every six months or when the red
ball indicator no longer floats in the internal electrode solution, whichever comes first.
Failure to replace the Reference Electrode at this interval can cause all three of the errors
mentioned.

Troubleshooting Guide
Symptom Problem Correction
1. No power.
2. Communication
Turn off power, reapply power.
System does not failure.
respond 3. RS232 cable is
disconnected or Reconnect or replace cable.
damaged.

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Symptom Problem Correction

4. ISE Module
connector has been Replace board.
damaged.
5. Component failure
Replace board.
on board.
1. Misalignment of Remove electrodes.
electrodes. Inspect O-rings. Reassemble properly.
2. Calibrator solutions. Replace Reagent Pack.
Low Slope Na+ or 3. Electrode (low
Replace electrodes.
K+<52mV/decade slope).
Cl<40mV/decade, 4. Air bubble on
Li+<47mV/decade or Remove electrode, tap to dislodge
reference electrode
High Slope Na+, K+, or bubble, replace, and recalibrate.
membrane.
Li+>64mV/decade
Cl>55mV/decade 5. Reference Replace reference electrode and
electrode. retest.
6. ISE Module or fluid
Change ISE Module location if ambient
temperatures exceed
temperature is too high.
32° C. (high slope).
Replace problem electrode and
1. Electrode.
recalibrate.
2. Electrical noise Find source of spike and eliminate.
Noise Error Flag Single
spike from
electrode
environmental source. Check instrument grounding.
3. Component failure
Replace board.
on ISE Module board.
1. Reference Replace reference electrode and
electrode. recalibrate.
2. Electrical noise Check for electrical noise coincident
Noise Error Flag with activation.
spike from
Multiple electrodes
environmental source. Check instrument grounding.
3. Component failure
Replace board.
on ISE Module board.
Purge the Calibrant A and recalibrate
1. May occur when
the ISE Module.
new electrode or
Drift Error Flag Single If the electrode is new it may initially
Calibrant A is
electrode drift as it rehydrates over the course of
installed.
15 minutes.
2. Electrode. Replace the electrode and recalibrate.
1. May occur when
new electrode or
Purge Calibrant A and recalibrate.
Drift Error Flag Multiple Reagent Pack is
electrodes installed on system.
2. Reference Replace reference electrode and
electrode. recalibrate.

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Symptom Problem Correction

3. Electrical spike from Find source of spike and eliminate.
environmental source. Check instrument grounding.
4. Component failure
Replace the board.
on ISE Module board.
1. Insufficient sample
pipetted into ISE Instrument must deliver 70 μL.
Module sample entry Increase dispensed sample volume.
port.
Instrument must deliver sample free of
2. Bubbles in Sample
bubbles. Check probe tubing’s.
Air in Sample 3. Fluid leaks Determine source of leak and resolve.
Electrodes not seated properly.
4. Sample not Remove electrodes. Inspect O-rings
positioned and reassemble.
Replace pump tubing.
5. Pump tubing
Replace pump tubing.
obstructed.
Electrodes are not properly seated or
1. Sample and
compressed. Check compression plate,
Calibrant A are
spring, and seal. Remove and
segmented with air.
reassemble electrodes.
Use Manual Movements>Cleaning>ISE
Module cleaning
2. Fibrin or salt is
plugging the electrode Remove electrodes and clean or
flow path. replace electrode with plugged flow
Air in Sample and path. Reinstall electrodes and
Calibrant A recalibrate.
3. Bubble detector is
Replace bubble detector.
malfunctioning.
Check electrical connections.
4. Waste pump is Replace pump tubing.
malfunctioning. Replace motor.
Replace pump.
Electrodes are not properly seated.
Check compression plate, spring and
seal.
Ensure that all electrodes and O-rings
1. Calibrant B and are properly installed.
Air in Calibrant B and
Calibrant A are Ensure tubing between reagent pack
Air in Calibrant A
segmented with air. and sample entry port is connected
properly.
Replace tubing between reagents pack
and sample entry port.
Reagent low or out.

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Symptom Problem Correction

Use Manual Movements>Cleaning>ISE
Module cleaning
2. Fibrin or salt is
plugging the electrode Remove electrodes and clean or
flow path. replace electrode with plugged flow
path. Reinstall electrodes and
recalibrate.
Check electrical connections.
3. Waste pump Replace pump tubing.
malfunction. Replace motor.
Replace pump.
4. Bubble Detector
Replace bubble detector.
malfunction.
Replace reagent pack with a
1. Calibrant A.
new one, prime, and recalibrate.
2. Tubing from
reagent module is
Reconnect or replace tubing.
disconnected,
Air in Calibrant A plugged, or crimped.
Check electrical connections.
3. Calibrant A pump is Replace pump tubing.
not working properly. Replace motor.
Replace pump.

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8.2 Methods

Identification: (Test ID, Name, Units): Similar to chemistry methods. Units for ISE
measurements are usually mmol/L (verify in Options that this unit is set). For conversion
to other units or matching correlations with other systems, use Method’s Correlation slope
and offset tabs, to adjust measurements.
Sample Type: refers to the type of sample (serum, urine, etc.)
Ion: any of the installed ions as defined in ISE parameters.
Reference Class: Normal expected values

8.3 Operation

8.3.1 Maintenance operation

To access select
Maintenance > Operations > ISE

When new pack is installed purging is automatic (press Start Up). Also, use it when a
maintenance cleaning of system is performed.
Cleaning warnings are automatically indicated when required. Click on the command and
perform an ISE cleaning procedure. Nevertheless, use this option when additional
cleaning or calibration is necessary.

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8.3.2 Automatic Operation

Serum
Serum samples are used undiluted and placed in sample vials together with other
samples. Analysis can be performed either for electrolytes only or mixed with any
chemistry method.
ISE methods can be programmed as samples, controls, STATS, etc.
System will give to ISE samples higher priority than chemistry methods but lower than
coagulation and stat samples.
Results, printouts, etc. are performed as usual and no separation of ISE from other
methods whatsoever is applied.

Priming
It is recommended the use of one dummy sample as the first serum ISE sample. This will
help to stabilize results when batch operation is performed.

The priming operation is controlled by Use Parameters (Maintenance > Parameters >
Use) where the prime operation is enabled (green) or disabled (red).
Priming should not be confused with pre wash. Priming is one or more extra samples if
instrument has been inactive for a given time.

Urine
Urine samples are automatically diluted by system, according to the dilution ratio
specified in ISE parameters.
Urine diluent is provided as a separate reagent and manual filling of system vials and
positioning in reagent tray is necessary.
It is recommended to use at least one extra dummy sample at the beginning of a batch if
ISE module has been inactive for a given time. This will help to stabilize electrodes and
improve precision.

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9 Maintenance
9.1 Counters
It can be accessed through
Maintenance > Operations > Wear

Table includes actual reading on syringes, tubing, drying blocks, pump rotors, diluter
valves, dryer pumps, ISE electrodes and lubrication period. Also the latest replacement
dates are shown.

When a replacement is made, the reset button must be pressed and counter put to zero.

Check regularly this table and be sure to have spares for all elements.

In all cases, when instrument is reconnected or when automatic operation starts, a

warning message is issued:

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9.2 Scheduler

Maintenance Scheduler can be accessed either from the warnings bar at the main
window of the software or from Maintenance – Scheduler as indicated at below screen
shoot.

The scheduler window is further divided into two tabs which are the Status and Schedule
ones. Both window are analytically presented at next sections. Red color indicates that
one or more of the scheduled tasks has not been completed.

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9.2.1 Schedule

A number of parameters which involve daily lab routine operation are edited in this screen
in order to set the preferred times for maintenance tasks.

Requirements include the working routine hours (time that operation of analyser starts
and time that usually activities finish), how often a service back up should be performed,
the preferred time as well as where it should be saved (e.g. which folder of main hard
disk). The preferred day and time during the week to perform the weekly and monthly
maintenance. Operator can also determine the frequency and time during the day for
performing a water cuvette blank. Cuvette blank is recommended to be performed daily
during start up.

It is recommended to set the times earlier than operation starts and finalizes in
order to include some of the tasks during the automatic start up as well as
provide enough time at the end of the day to perform the maintenance
procedures. Press Apply Changes after modifying any of the described
parameters in order for changes to be saved.

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9.2.2 Status

A list of maintenance tasks is presented in this window with the dates and times that were
last executed as well as the times that are next scheduled for. The activities are mainly
separated into Daily, Weekly and Monthly maintenance routines and can be performed
directly from this screen by pressing the corresponding Perform button which will either
initialize the task directly or will transfer to the corresponding screen of the software.
Additional details for some of the tasks can be found in separate sections of the
maintenance chapter.

It is recommended to set the times earlier than operation starts and finalizes in order to
include some of the tasks during the automatic start up as well as provide enough time at
the end of the day to perform the maintenance procedures. Press Apply Changes after
modifying any of the described parameters in order for changes to be saved.

System Flush. System flush is required at least once per day and can be set to be
automatically performed during analyser start up at the beginning of the day. In case that
analyser has stayed operational and has not been switched off then the system flush
warning will come up at the specified time. The task can be performed directly from this
screen. Additionally, system flush is required after any refilling action of the system wash
bottle or any other operation that can introduce bubbles into the analyser tubings.

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Intensive Cuvette Cleaning. Is scheduled to be performed at least on a weekly basis.

Duration of operation is approx. 45 min and requires a filled reagent vial at the reagent
tray. By pressing perform the screen will be transferred to the specified section where the
task can be completed. Please see relevant section for additional details on operation
and cleaning solutions to be used as well as higher frequency if particular circumstances
could require it.

Service Backup. It is recommended to be performed weekly and ensures additional

safety in case that a fatal hardware or system crash incident takes place. Duration can
vary from a few seconds up to a couple of minutes, depending on the size of the
database.

Cuvette Water Blank. It is recommended to be performed every day during start up

operation and takes approx. 15 minutes to complete. Perform button transfers to the
corresponding section for completion. Options at scheduler allow task to be programmed
also at the end of the daily routine as well as on weekly basis.

Change solutions. If not otherwise specified for particular diluents and cleaning
solutions, this is a reminder towards the operator to change diluents and cleaning
solutions at the reagent tray at least on a weekly basis to avoid deterioration and
contamination of them.

Manual Tip Clean. It is scheduled for once per week but recommended to be performed
even daily or otherwise required. Please see corresponding section for details.

Photometer Calibration. It is performed monthly and perform button transfers to the

corresponding screen.

Washer Volume Calibration. It is recommended to be performed monthly if not

otherwise specified. Perform button transfers to the corresponding screen and initializes
task.

Clean System Bottles. System bottles should be removed and cleaned on a monthly
basis. Additionally decontamination of the system is also recommended at same
frequency.

Additional tasks as well as operational guidelines are provided at sections below as

well as a summary table with all the maintenance tasks to be performed on a daily,
weekly and monthly frequency.

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9.3 Daily QC
According to international recommendations, we recommend to run quality control
procedure on a daily basis or at the frequency stated in relevant accreditations for the
measured parameters to ensure proper operation. QC protocols must be established
according to the rules of the laboratory concerned.

9.4 Daily care and maintenance

Recommended operations should be performed at the start of every run or on demand.

9.4.1 ISE Priming serum

For instruments having ISE option, always keep at the ISE priming position, a vial with
fresh serum from a sample pool or a control. This is to provide the necessary electrode
conditioning to extend useful life of the electrode and ensure optimum operation of the
ISE module.

To modify priming settings, log as supervisor and access

Maintenance > Service > Parameters > Instrumental

then choose ISE tab to enable/disable ISE priming, Define the number of repetitions, and
set the idle time. Replace ISE priming serum daily to avoid formation of clots.

9.4.2 Inspection and cleaning of probe

The sample probe is a delicate part of the instrument. Precision of results is essentially
dependent on how well the sample probe is maintained. Probe tip must be kept clean.
Inspection of probe should be done daily and cleaning should be performed weekly
or on demand.

 Gently remove protein deposits or solids from tip with a cotton swab soaked in
Solution 1. Dry with lint-free tissue.
Never use abrasive material: the delicate tip could be damaged.
If the probe tip is defective, remove cover of probe arm, loosen setscrew and spring that
retains the needle and pull it up. Install new probe. Tighten setscrew connector fitting and
cable and recalibrate the tip positions.
Important: Perform all automatic cleaning cycles required by the instrument.

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9.4.3 Hydraulic testing

 Purge hydraulic system from Scheduler or from menu Maintenance / Operations,

Hydraulic tab, and press System Flush. This procedure is also automatic on start-up if
time elapsed from previous completion was exceeded. During process look for:

Presence of bubbles or air gaps in system

Air gaps and bubbles should be flushed, if present, particularly after the filling operation of
system bottles. It is normal to find some bubbles in the peristaltic pump tubing. Repeat
process if necessary.

In case new bubbles generate in the process, determine the origin:

Come from reservoir?
Generate in pump connectors?
Generate in syringe connectors?
Are they visible only in probe tip?

Leakage in peristaltic pump

Replace pump tubing even if cycling time is not reached as shown on 9.11

Constant and uniform flow from probe tip

This indicates hydraulic system is operating normally.

No droplets hanging on probe tip

When system operates normally, no droplets should be present on outer part of tip. If tip
is dirty, droplets will adhere to external surface. If obstructions are present in the system,
flow will be intermittent and drops will continue to fall after pump has stopped, and
eventually, one will remain hanging from the tip.

When system operates normally, flow will stop instantaneously when pump stops.

9.4.4 Replacement of wash solution and empty waste

This analyser washes the sample probe between sample aspirations, requiring
approximately 3 mL of wash solution for each performed test. The washing solution is
pumped up from its reservoir and is disposed into the waste reservoir, both provided with
the instrument. Both reservoirs have electronic level sensors.

If wash solution volume is not sufficient, a message will warn after initialization.

It will not stop instrument operation as enough washing solution is still present. The run
can be completed before refilling the reservoir.

Check and Replace daily if needed (recommended action before instrument start
up). If no refill is carried out, message reappears before next run.

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Check waste container and empty, if necessary.

Control tip cleaning and rinsing solutions. Refill, if necessary.

Notice: Never leave uncapped the cleaning solution. It will lose its cleaning power
in few hours.

9.4.5 Cuvette Water Blank

Cuvette water blank can be accessed directly from the Scheduler > Status screen or
through Maintenance > Cuvette Blank. Press Start to initiate. Washers are dispensing
system wash in all cuvettes and photometer records the background measurement of
each cuvette at all 12 filters. The process takes places into two parts; at first water is
dispensed at first 40 cuvettes, absorbances are read, cuvettes are then dried and then
the other half of the cuvette tray is filled and read. Process takes approx. 15 min and if
acceptance criteria are fulfilled, cuvettes are considered clean and not rendered
unusable.

9.4.6 Intensive Washer cleaning

The washer cleaning system and pipes can be cleaned with an intensive procedure
located in

Maintenance > Operations > Hydraulics > Intensive washer cleaning

This procedure consist of using a suitable cleaning solution defined in the screen of
cleaning solutions (See Error! Reference source not found.) with a volume up to 500
microliters and repeated up to 10 times (default value is 4), either back or front or both. At
the end, a normal wash and drying cycle is performed.

9.5 Weekly maintenance routine

Proceed first with daily maintenance routine.

9.5.1 Intensive Cuvette cleaning

Before starting every automatic cycle, the instrument will check the cuvette status. If the
number of cuvettes with absorbances out of the limits defined in the Parameters > Use is
greater than the pre-fixed value of 20, the cycle will stop and replacement of cuvettes will
be asked.

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Nevertheless, cuvettes can receive an intensive wash by selecting the operation in

Maintenance > Operations > Hydraulics > Intensive Cuvette cleaning

or directly from Maintenance > Scheduler > Status window which provides a link to above
window. Operator can select volume, time of action and washing solution. Default values
are recommended. Make sure that enough cleaning solution has been positioned on
board. This action is very useful for cuvettes used with latex type of reagents or other
contaminant fluids. Perform it at least once per week or more often if needed. Dilute
sodium hypochlorite (0.3-0.5%) could be used to perform this task if no specified solution
is provided.

9.5.2 Change solutions

A number of diluent and cleaning solutions can be defined and could be present at the
reagent tray. Some of them are set as default and others can be programmed by
operator. These solutions should be checked regularly and it is recommended to be
replaced every week, if not otherwise specified (e.g. ISE cleaning solution can stay on
board for up to 4 weeks). This is particularly important for diluent solutions which
sometimes lack preservatives and could create contamination issues.

Refilling, should be performed as necessary.

Notice: It is strongly recommended to place caps on cleaning solutions if left on

board since their performance as cleaning agents could downgrade with exposure
to air.

9.5.3 Service Backup

Service back can be performed directly from Maintenance > Scheduler > Status or from
Data > Service backup. It is recommended to be performed at least once per week since
it provides all the necessary information needed to reinstall the system and retrieve
necessary data. Additionally backups could be saved to external hard drives too in order
to be able to use them as rescue tools in case that computer hard drive fails.

9.6 Monthly maintenance recommendations

Proceed to the weekly maintenance routine.

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9.6.1 Washer volume calibration

Following the link as provided from the scheduler on directly from

Maintenance > Washer Volume Calibration

It is possible the testing and calibration of the washer volume. Screen will show the pump
steps settings and new pump steps required for system delivery in all four wash steps.
Operator can save new settings or return to default values. Target is that all deliveries are
between 500 and 700 μL.

Its performance is recommended at least once per month.

9.6.2 Intensive Washer cleaning

The washer cleaning system and pipes can be in turn cleaned with an intensive
procedure accessed from
Maintenance > Operations > Hydraulics > Intensive washer cleaning
This procedure requires of using a suitable cleaning solution defined in the screen of
cleaning solutions with a volume up to 500 μL and repeated up to 10 times (default value
is 4), either back or front or both. At the end, a normal wash and drying cycle is
performed.

9.6.3 Other tasks

Perform a full photometer calibration. On the same time make sure that the system has
been flushed.

Empty and clean washing solution reservoir and waste bottle. This is a manual procedure
and is not controlled by analyser software. This is an important task and should be
performed regularly as indicated. Build of dirt and potential biological contamination within
the containers could seriously influence performance of the analyser. Further, it is
recommended periodically to perform an additional step in order to decontaminate the
tubing’s. Place dilute hypochlorite (0.3 %) in a container and immerse in the tubing’s. Run
2x system flush procedures and then rinse (3x flush) with DI water. If possible leave the
system for a few hours with DI water before placing back the system wash bottle.

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9.7 Maintenance on demand

It is of extreme importance that the instrument is fully turned off and the power cord
unplugged from the wall outlet to safely perform any maintenance or service procedure.

During maintenance procedures, the safety and warning precautions must be observed
as outlined in the preceding paragraph.

The exterior of the analyzer casing may be cleaned periodically to remove dust grease
and other contamination. It is not necessary to clean the inside. Use soft cloth dampened
with a mild solution of detergent with water.

The owner shall be responsible for maintenance of the analyzer. Wear or damage caused
by lack of normal maintenance or by misuse of the analyzer shall not be considered as
defective workmanship and material.

Must be performed when instrument indicates the need of corrective action (message
indicating replacement of a part required), or when operation anomalies are encountered,
relative to maintenance:

 Hydraulic malfunction: droplet appearance on probe tip or bubbles in system.

 Poor cuvette drying or cleaning action (replace drying block, perform washer unit
maintenance, etc)

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9.8 Summary of maintenance activities

A recommended summary of tasks for daily, weekly and monthly maintenance is

presented in the table below:

Frequency Task

Daily Probe Tip Inspection

Fresh control or serum at ISE prime position

Refill system wash bottle

Empty waste bottle

System Flush

Cuvette Water Blank

Weekly Manual Tip Clean

Check & Replace if needed, diluents and cleaning

solutions at reagent tray

Service Backup

Intensive cuvette cleaning

Monthly Photometer Calibration

Washer Volume Calibration

Clean System Bottles

Intensive washer cleaning

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9.9 Maintenance on demand

Must be performed when instrument indicates the need of corrective action (message
indicating replacement of a part required), or when operation anomalies are encountered,
relative to maintenance:

 Hydraulic malfunction: droplet appearance on probe tip or bubbles in system.

 Poor cuvette drying or cleaning action (replace drying block, perform washer unit
maintenance, etc)

9.10 Lamp replacement

When required, lamp replacement can be easily performed by user following these
instructions:

 Turn off and unplug instrument from Mains.

 Remove lamp cover on left side of instrument, lamp will be visible.

 Press lever on lamp socket to remove burnout lamp.

 Insert new lamp in place securely. There is only one possible position due to
different size of connecting pins.

 Lamp is pre-focused, does not require other handling.

 Reinstall cover, tighten screws.

 Execute photometer calibration.

Do not touch lamp bulb. If touched accidentally, clean with lint-free cloth or tissue paper
and alcohol.

9.11 Pump tube replacement

The pump tubing has a useful life determined by a pre-fixed number of work cycles.
When that number is surpassed, instrument will show a message for tubing replacement.

At the earliest opportunity the replacement must be done (it is not necessary to stop the
automatic cycle).

 Pull fittings up and out of bracket.

 Pull tube out of its lodging, rotating the pump rotor by hand if necessary.

 Insert new tube on the fittings.

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 Install in inverse order.

 Slowly turn the rotor by hand until tubing is properly lodged.

Once replaced, proceed to reset cycle counter in Maintenance > Operations > Wear.

9.12 Dryer block replacement

Drying block should be replaced if symptoms of poor drying capacity are detected or
when warning message is issued.

If cross-contamination is observed, first check if drying action is effective. Poor drying

implies block change.

The drying block can be replaced by unscrewing it downwards until free, and inserting a
new one in the pipe and screw it. Reinstall the washer head and rotate new block until it
mates with cuvette shape.

If operation is difficult, remove the washer head by removing two screws that fix it, (see
picture below) insert block and re-install wash head.

Once replaced, proceed to reset cycle counter in

Maintenance > Operations > Wear

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9.13 Syringe replacement

Instrument will give warning when the number of syringe cycles is close to their end of
useful life. When it occurs, it is not necessary to replace it immediately, but at the earliest
opportunity the replacement must be done.

For replacement, syringe must be all the way down, as indicated in the figure.

Proceed to Maintenance > Operations > Movements

Select in Diluter section, Fix, volume 500 microliters and press hand or key F.

Once replaced, proceed to reset cycle counter in

Maintenance > Operations > Wear

And initialize by returning to the main menu and pressing the initialization button.

After replacement, select Parameters, then Cycles and press the reset button 0.

This resets the counter; otherwise, the warning message will continue to be shown.

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9.14 Long term shutdown procedure

When a long term shutdown is planned for the instrument follow the procedure below,
bearing in mind that any part of the analyzer may come into contact, even accidentally,
with potentially infected samples: therefore set up adequate protection using the
necessary individual protection devices.

Be very careful of any splashing of residual decontaminant when disconnecting the

various tubes or touching the various parts of the hydraulic system, after
decontamination.

1. Remove all the consumable parts, still present, from the analyzer (sample cups,
test tubes, reagent bottles etc.).
2. Take out the water and cleaner tubes from the containers in order to empty the
hydraulic circuit. Perform full System Flush.
3. Place the water and cleaner tubes to the external container with at least one liter
of suitable disinfectant or decontaminant (e.g. hydrochloric acid HCl 1N diluted at
3%).
4. Fill the hydraulic circuit again by running a System Flush three times
5. Wait five minutes.
6. Take out the water and cleaner tubes from the container with disinfectant or
decontaminant and empty the hydraulic circuit again by performing full System
Flush.
7. Place the water and cleaner tubes to the external container with at least one liter
of distilled water.
8. Fill the hydraulic circuit again by running a System Flush three times.
9. Take out the water and cleaner tubes from the container with distilled water and
empty the hydraulic circuit again by performing full System Flush.
10. Shut down the analyzer.
11. Remove the power cord and cable connecting the PC to the instrument.
12. Carefully clean off the entire sample tray with decontaminant (hydrochloric acid
HCl 1N diluted at 3%) and a clean cloth, as well as its housing and all the
accessible surfaces of the analyzer.
13. Remove all the tubes connected to the analyzer and dispose remaining waste.
14. Remove the tubing from cleaner and water peristaltic pumps.
15. Remove and dispose all reaction cuvettes.

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10 Troubleshooting
Instrument related problems can be classified into three groups:

 Operation malfunctions with visual, acoustic or printed warnings.

 Visible faults or problems.

 Measurement inconsistencies (for example: GOT method with high dispersion).

10.1 Messages and Warnings

Self-explanatory messages are not included in the present listing.

Message Cause Action

Change reaction All 80 cuvettes are Replace reaction cuvettes.
cuvettes. used.
Front / Back syringe Pre-set limit is Replace at the earliest
exceeded. surpassed. opportunity.
Front / Back pump turns Pre-set limit is Replace at the earliest
exceeded surpassed. opportunity.
There is no enough Cleaning or rinsing Replace required wash
cleaning solution. solutions are missing. solution.

In addition, below are listed all the system messages that are recorded at the
corresponding section at the main/home screen of the software;
 Automatic photometer calibration
 Tip cleaning not performed
 Working with low DI water
 Reagent integrity fail METHODID ABS
 Bottle exhausted. Reagent SOLUTIONID SOLUTIONNUMBER BOTTLEID
 Bottle expired. Solution METHODID RAGENTNUMBER BOTTLEID
 Bottle expired. Reagent METHODID RAGENTNUMBER
 Bottle on board expired. Reagent METHODID RAGENTNUMBER BOTTLEID
 QC out of range: SAMPLEID METHODID
 Clot detected on sample SAMPLEID - Sec.: XX Pos: XX
 Out of reagent - Pos XX SOLUTIONID
 Collision in reagent - Pos XX SOLUTIONID
 Out of sample - Sec. XX: Pos: XX Sample Id SAMPLEID

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 Collision in sample - Sec. XX: Pos: XX Sample Id SAMPLEID

 Invalid BCR label in position POS REAGENTCODE.
 Method/Solution code not exist in position POS REAGENTCODE.
 Solution not exist in position POS SOLUTIONID.
 Reagent not exist in position POS METHODID RAGENTNUMBER.
 Filter XX saturated or without energy
 Front arm temperature out of range XXX ºc
 Back arm temperature out of range XXX ºc
 Reaction tray temperature out of range XXX ºc
 Out of sample - ISE Prime
 Collision in sample - ISE Prime
 ISE Invalid Calibration ION
 ISE Expired Pack
 ISE initialization failed
 ISE Invalid Pack Data
 ISE Bubble Calibration A: XXX M:XXX L:XXX
 ISE Pump Calibration A: XXX B: XXX W: XXX
 ISE filling error - Sec.: XX Pos: XX
 ISE cleaning can´t done
 Unstable XX ion

10.2 Visible faults

10.2.1 General faults

Symptom Corrective Action

Drops on probe tip after Verify hydraulic system in accordance to user’s

dispensing manual.

Clean probe tip by submerging in Solution 1 for 5

minutes.

Drops on tip after wash cycle. Verify hydraulic system for leaks or obstructions.

Abnormal noises. Defective fans.

Moving parts blocked or frozen. Contact Technical

Support.

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Symptom Corrective Action

Temperature in reaction tray is Room temperature too high, (should always be at

too high. (Do not be concerned least 4°C lower than selected working temperature).
about arm probe temperature)
Example: For 37°C incubation temperature, Room
temperature should not exceed 33°C.

If Room temperature is within limits, and problem

persists, call Technical Support.

Temperature in reaction tray is Room temperature excessively low. Verify

too low. (Do not be concerned instrument operating range, and adequate the room
about arm probe temperature) temperature.

If room temperature is within specified range and

problem persists, call Technical Support.

Windows Fault In case of Windows failure please check the

following:

Install pending updates. Some installation do not

“like” to have pending updates.

Restart the computer. Leaving Windows for weeks

without restarting is causing it to slow down.
Hibernation is doing the same. It is highly
recommended to restart the computer every day.

Defrag the disc. If the hard drive is getting slow,

Windows and all the programs will run slower. Run
the defragmentation tool provided by the OS.

Antivirus. Be sure Rayo.exe and the entirely Rayo

folder is excluded from being scanned by the
antivirus. You must know newer antivirus tents to be
“heavy” and require extra resources older computers
do not have.

Too many applications. Be sure computer is used

exclusively for the Pictus software.

Overloaded Database To avoid overloading database with huge amount of

information stored by the Pictus Software please
perform the following actions regularly:

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Symptom Corrective Action

Shrink the Database. This will speed up the

database access.

Periodically remove the historic parameters such as

QC and Samples. The information is still available
from the cumulative historic. After changing the
parameters, software needs to be restarted in order
to apply the changes (delete old info). Shrinking the
database after restart is an excellent idea.

10.2.2 Automatic cuvette washer malfunctioning.

Symptom Corrective Action

At the end of wash cycle, tiny Verify that all pumps are working.
water droplets remain on cuvette
Verify that no tubing are clogged
walls
Replace drying block
Calibrate washer unit position.
High cross-contamination Identify cross-contaminants and set methods in the
Table of interferences
Increase the wash volume
Increase the number of wash cycles

10.3 Measurement inconsistencies

Consider storage and handling of reagents, standards and controls:

1. Verify expiration date, storage temperatures on and off analyser.

2. Check that reagent was not frozen.

3. Check colour changes, sediments, turbidity, no foam.

4. Check for mixed reagents from different lots or re-use of reagent bottles.

All methods
1. Verify cuvettes for dirt or scratching.

2. Remove cuvettes from reaction tray and check volumes for affected cuvettes.

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3. Verify there are no bubbles or droplet.

5. Verify there are no obstructions on probe, check for non-constant or regular flow.

6. Recalibrate photometer.

7. Perform energy, noise and photometric stability tests.

Colourimetrics with high dispersion

1. Replace sample by a standard and verify dispersion again, check reaction cuvette-
beam alignment.

2. Perform hydraulic verification.

3. Check for sample centrifugation, increase time and speed.

4. Perform energy, noise photometric stability and dilution tests.

Colourimetrics with proper dispersion but values too high or low

1. Verify standard, compare calculated factor with stored (historic) factors, and
recalibrate method. If problem persists, replace standard and/or reagent.

2. Clean probe and check for cross contamination by changing the order of dispensing
(“Time priority for reagents” parameter). Check proper probe washing/clean probe.

3. Check for exceeded method linear range; compare method definition with reagent
specification.

4. Verify sample volume is not excessive.

5. Perform stray light verification, high range and low range linearity test, and dilution
test.

Kinetics with high dispersion or low linearity

1. Verify if incubation time is too short or heaters are not working properly.

2. Verify for abnormally high initial absorbance for decreasing kinetics (problems with
reagent preparation) or too low on increasing kinetics. Replace reagents and
compare results.

3. Check lamp for stability.

4. Use new cuvettes and test again, check cuvettes for dirt or scratching.

5. Perform noise and photometric stability tests, clean filters.

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6. For some kinetics: verify if sample volume is too low.

7. For some kinetics: verify centrifugation (increase time and speed).

Kinetics with normal values too high

1. Perform energy, noise and photometric stability.

2. Perform temperature verification.

3. Some kinetics: incorrect factor for selected temperature and volume.

4. Replace lamp, clean filters.

Kinetics with normal and pathological values too high

1. Verify incubation time and temperature. Perform temperature test.

2. Verify if factor matches selected temperature. Remember selected temperature is

usually 37oC.

Kinetics with normal and pathological values too low

1. Check for short incubation time or low temperature.

2. Verify if factor matches selected temperature. Remember selected temperature is

usually 37oC.

Kinetics with values too low or too high on the whole range
Verify if factor matches selected temperature. Remember selected temperature is
usually 37oC.

Two point kinetics (high dispersion)

1. Verify if standard absorbance is too low (verify data provided by standard
manufacturer).

2. Verify initial consumption is too high (verify data provided reagent manufacturer).

3. Perform energy tests.

4. Verify reagent handling and storage.

5. Check method parameter for reagent, low sample volume or too short interval
times.

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6. Check time table for dispersion on first measurement.

Two point kinetics (high dispersion)

Verify factor, standard and method for reagent.

Repetition or dilution (colorimetric or nonlinear kinetics)

1. Verify if sample volume is too high, check reagent linear limit.

2. Replace reagent and compare.

Repetition or dilution (two point kinetics)

This is not actually an error; it is because volume / absorbance change relationship
is not linear, and so it is necessary to dilute standard and compare.

Reactions (general comparison between reactions)

1. Control quality of water.

2. Verify proper usage of solutions (wash solution, rinse solution, etc.).

3. Use uric acid to check water quality.

4. Verify for frosted cuvettes (presence of salts).

5. Verify scratching or old reactions residues (not enough washing).

6. Perform instrument validation tests.

“Standard absorbance error” message

1. Check/replace standard.

2. Replace standard by a known concentration sample.

3. Decrease parameter “minimal standard absorbance”.

“Doubtful” flagged reaction

This message appears when concentration after dilution is lower than measured
before dilution; it could be due a bubble, dirty probe or problem in reagent.

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11 System tests
To access to system tests, select

Maintenance > System test

Results of tests are stored and printed out in PDF files in the Working Directory\System
Tests.

11.1 Temperature

This test measures the time required for reaching pre-set temperatures and final stability
of reading. It includes cooler tray temperature. The test records the minimum reached
temperature and the last time in which the temperature reached the band between
minimum and maximum allowed values. If the temperature is turned off, the test stops
and a warning is issued.

11.2 Stray light

This test is based on the use of two solutions: one UV sharp blocking and other visible
blocking.

Visible blocking is usually accomplished with potassium dichromate in high concentration

(more than 5 g/L) and should block all light passing the cuvette at the specified
wavelength. If it fails, light is arriving directly to sensor without traveling through the
cuvette.

UV blocking, if visible is passed, indicating actual filter stray light. The use of Sodium
Nitrite, 50 g/L and reading at 340 nm is recommended.

There are two options: either instrument dispenses solutions or user put them directly in
the selected cuvettes. Use “Already dispensed” for selection.

Test is passed if read values are less than 0.1%T.

Volume selection can be used to determine minimum volume that can be safely
measured.

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11.3 Noise

This test determines the departure of individual readings from the mean value. Noise is
evaluated separately from drift. For stability evaluation, total time (Number of readings X
Time interval) should be at least 10 minutes. Noise evaluation is performed without
moving tray and data are directly related to photometer behaviour.

When Absorbance correction is selected (recommended for solutions and not for filters),
results are expressed as equivalent to 1 cm cuvette measurements.

Noise test is relevant for absorbance over 1.300. Potassium Chromate (1.2 to 1.5 g/l in
acidic media) is recommended.

Relevant data are peak-to-peak (maximum) difference. They should not exceed 0.002 for
1 minute total time.

11.4 Stability

Stability test is very similar to noise test, but the tray is randomly moving between
readings. Comparison of data from noise and stability tests can give a hint on mechanical
positioning problems. Use conditions as described in noise test.

11.5 Tip Pump

This test allows determining if washing tip pump is delivering the correct amount of water.
Procedure is performed in a reagent bottle located in position 1, where initial liquid level
should be at least to a height of 2 cm. Procedure is repeated several times and averaged.

11.6 Level detection

Reagent is taken from a vial located in a fixed position and tip reaches the surface of other reagent
located in a different position. Next, reagent is delivered in the original one. This procedure is
sequentially repeated while volume is varied every cycle within fixed limits. Results and plot will
show if level detection is accurate.
Use this test if detection problems are observed with a given method or Brand.
When using, be sure that no foam is present in reagents or samples. If test is repeated many times,
be sure that no foam is formed in the process.

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11.7 Washer hydraulics

Calibration for cuvette bottom should be performed, prior to other operations.

A liquid pump level check will be performed by dispensing water with D1 to D5 and
measuring the liquid level with sensor probe (positions 2 to 5). The calculated volume will
be recorded for each station (1 to 5).

S1 S2 S3 S4 S5 B

D1 D2 D3 D4 draining reaction off

dispensing solution
draining solution
water off drying block

A liquid suction level check will be performed drawing water with S1 to S6 and measuring
the liquid level (if any) with sensor probe. To be able to measure such small remnant
amount, the syringe full loaded with water (500 L) will dispense 100 L in each position
(1 to 6). The calculated remnant volume will be recorded for each station (1 to 6).

A liquid pumping level stability test will be performed dispensing water with D1 to D5, the
number of times determined by the parameter, in different cuvettes (positions 6 to 9, 10 to
13,) and measuring the liquid level with sensor probe. The following volumes/parameters
will be recorded for each station (1 to 5):
 Average volume;
 Standard deviation and variance;
 Minimum and maximum volumes;
 Difference between minimum and maximum volumes;
 Difference between minimum and maximum average volumes of the 4 stations;
 Relative deviation error of average volumes.

A cuvette wash will be performed in all the used cuvettes.

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11.8 Washer

Washer test consists of performing cuvette cleaning cycle on a programmed number of

cuvettes. Absorbances are read on new cuvettes before cleaning action, immediately
after cleaning and at some fixed time (Drying time). All three data are shown in the graph.

If cuvettes are properly dried and not scratched by the system, values should return to
the original ones, with a tolerance of about 0.020 abs.

11.9 Dilution

Dilution test should be performed with a sample of Potassium Chromate of 5 g/L in acidic
solution. Use as reagent the tip washing solution.

For a final volume of 4/400, CV should be less than 1.5%

11.10 Photometer linearity

This test is intended for evaluation of photometer linearity. To achieve this goal, the test
will measure absorbance (A0 to A4) of 5 different solutions (points 0 to 4) in front and back
channels using a specific filter. Each solution will be prepared by dilution of a stock
solution located in a specific on-tray position. For a default initial sample volume of 8
microliters, system will automatically generate dilutions of 0/300, 8/292, 16/284, etc.
maintaining the total solution volume unchanged.

A cuvette diluent blank will be performed prior to dispensing using a certain volume.
Dilution will use the remaining volume of diluent. After dispensing, a certain time will be
observed prior to reading. A certain number of replicates will be done for each point. This
test differs from 11.11 in the range of volumes. For volumes above 8 microliters, it is
assumed that diluter linearity is out of question and any linearity departure is related to
electronics or optics.

11.11 Diluter linearity

This test requires a concentrated Potassium Chromate solution (3 g/L in Perchloric 5

mmol/L) and washing solution as reagents. Given an initial volume (3µL as default)
system will generate dilutions using 1, 2, 3, 4 times the initial volume. Linear correlation
and departure from linearity are evaluated. Departures of +/- 5% are accepted.

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11.12 Level detection

Reagent is taken from a vial located in a fixed position and tip reaches the surface of
other reagent located in a different position. Next, reagent is delivered in the original one.
This procedure is sequentially repeated while volume is varied every cycle within fixed
limits. Results and plot will show if level detection is accurate.

Use this test if detection problems are observed with a given method or Brand.

11.13 Chemistry analysis

Test allows selecting any method from any already defined Control Set and perform
statistical analysis. Several analysis on methods belonging to the same control can be
measured. Precision is set default in 3% but operator should decide the required level.

11.14 Clot detector

Several tests can be made over both detectors (front and back):

Noise: performs an evaluation of the pressure sensor baseline.

Calibration: evaluate the detection window, pressure jump, and pressure jump CV.

Dilution Test: should be performed with DI water as sample and reagent. Pressure ratio
and clot ratio are checked.

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12 Background
12.1 Methods types and calculations

Photometric methods can be split up into 3 categories as follows:

12.1.1 Single point end point

Readings

A single absorbance reading (A1) is taken at specified time after reagent addition. Other
absorbance reading (Ae1) may be taken immediately after the first reading for extra
precision.

Measurement

M = A1 - B.

where B is the measurement of the reagent blank if required, otherwise set to 0. The
reagent blank determination is analogous to sample reaction.

If extra precision is required, measurement is computed as the average of the first and
extra precision readings as

M = ((A1 + Ae1) / 2) - B

Limitations

Reagent times for R2/R3 (if any) shall be 0.

12.1.2 Two point end point

Readings

The first absorbance reading (A1) is taken just before last reagent addition. The second
absorbance reading (A2) is taken at specified time after last reagent addition.

Extra precision

Other absorbance readings (Ae1 and Ae2) may be taken immediately after each reading.

Measurement

The measurement is calculated as

M= (A2-F*A1) – B

Where F is a Volume Factor Correction given by

F= (V1 + Vs ) / (V1 + V2 + Vs)

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With V1: first reagent volume

V2: second reagent volume

Vs: sample volume

If no correction is applied, formula becomes

M = (A2 - A1) - B.

where B is the measurement of the reagent blank if required, otherwise set to 0. The
reagent blank determination is analogous to sample reaction.

If extra precision is required, readings are computed as the average of the first and extra
precision readings as

M = ((A2 + Ae2) / 2 - (A1 + Ae1) / 2) - B.

Limitations

Reagent times for R2/R3 shall be greater than 0.

12.1.3 Fixed point

Readings

The first and second absorbance readings (A1 and A2) are taken at specified times (NT1
and NT2) after last reagent addition. Real reading times in seconds since last reagent
addition are observed (RT1 and RT2).

Extra precision

Absorbance readings (Ae1 and Ae2) are taken 6 seconds before NT1 and NT2. Real
reading times since last reagent addition are observed (RTe 1 and RTe2).

Measurement

The measurement is calculated as

M = ((A2 - A1) · (NT2 - NT1) / (RT2 - RT1)) - B.

where B is the measurement of the reagent blank if required, otherwise set to 0. The
reagent blank determination is analogous to sample reaction.

If extra precision is required, absorbance readings are interpolated from Aei at RTei and
Ai at RTi as

AIi = Aei + (Ai - Aei) / (RTi - RTei) · (NTi - RTei)

and measurement is calculated as

M = (AI2 - AI1) - B.

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12.1.4 Kinetics

Readings

Absorbance readings (Ac1 and Ac2) for rate evaluation (consumption) are taken at
specified times (NTc1 and NTc2, with values of 30 and 45 s) after last reagent addition.
Real reading times in seconds since last reagent addition are observed (RTc1 and RTc2).

Absorbance readings (A1 to An) are taken at specified times (NT1 to NTn, equally time
spaced) after last reagent addition. Real reading times in seconds since last reagent
addition are observed (RT1 to RTn). The number of readings is n = 10 in normal
conditions.

Once the 10 readings are taken, the linear correlation coefficient is estimated; also,
correlation is estimated but excluding all 10 points, one by one. System will select the
condition of best correlation, excluding the worst point, if necessary.

Measurement

Consumption evaluation is calculated per 1 minute as

C = (Ac2 - Ac1) / (RTc2 - RTc1) · (60 s).

The measurement is calculated as

M = b(Ai, RTi) · (60 s) - B

where B is the measurement of the reagent blank if required, otherwise set to 0. The
reagent blank determination is analogous to sample reaction.

with i from 1 to n, where b(y,x) function returns the slope of the linear correlation of
absorbance against time pairs of values as shown in the following equation:

where x is the represents the time and y the absorbance.

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13 Technical specifications
System Functions Reaction
System: Automatic full random access or Reaction cuvette: 80 re-usable PMMA
optimized batch mode. Stat sample priority. cuvettes. Optical length 6 mm
Throughput: 300 tests/hour mono reagent, Reaction volume : 180 – 500 µL
480 tests/hour with optional ISE unit.
Warm air incubator: room, 30ºC and 37ºC.
Methodology: End point, Fixed point,
Reaction time: 0 to 10 min.
Kinetics, Coagulation, calculated,
Turbidimetry, Enzymes, Drugs Stirring: After dispensing each reagent.
Calibration: Linear, Multi-linear, Sigmoidal, Washing station : 8 steps
Logit-log 4, Logit-log 5,Spline . Water consumption: 1.5 L / hour.
Up to 10 standards. Optical system
Quality control: Levey-Jennings and Twin Light source: Precision UV quartz halogen
plots, Westgard multi-rule. lamp
Automatic Sample Dilution: Pre-dilution Photometric Range: -0.1 to 3.6 A.
and Post-dilution on abnormal levels,
Measuring wavelength: 340, 380, 405, 450,
excessive substrate consumption and/or
490, 505, 550, 590, 620, 650, 700, 750 nm.
lack of linearity. Automated reflex testing.
Photometry: Single or Double-wavelength
Samples and Reagents Handling
simultaneous reading.
Pipetting Arm: One pipetting arm sample
and reagent, reaction pre-heater, probe Data Management
collision sensor and reaction mixer. Windows TM based Software.
Probe cleaning: Internal and external Interface LIS: bi-directional RC 232 C,
washing. according to ASTM E 1381-95,
Sample Tray: 95 (5 rack x 19 positions), ASTM E 1394-97.
Primary tube (length up to 100 mm), ISE Unit
Paediatric vial.
Module: MEDICA ISE module.
Sample volume: 2 to 100 µL/test (
in increments of 1 µL). Electrodes: Li+. Na+, K+, Cl-.

Reagent Tray: up to 72 single reagents. Sample types: Serum and Urine.

Multiple vials per test. Power Requirements

Refrigerated compartment at 8 °C ± 2 °C. 110-240V, 50/60 Hz, 600 VA .

Reagent volume: 1 to 3 reagents, 5 to 480 Operating conditions

µL/test each (in increments of 1 µL) Temperature: 18–30°C.
Reagent bottles capacities: 25, 45, 70 mL Relative humidity: 35–80% non-condensing
BCR: Internal bar code reader for samples, Air pressure: 84-101.325 kPa
control samples, standard solutions, and Storage and Transportation conditions
reagents.
Temperature: 5–35°C.
Clot detector: detects the presence of clot in
sample. Dimensions:
880mm(w) x 700mm(D) x 660mm (H) .
Weight: >95 Kg.

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14 Calibration

Calibrations are intended for servicing trained personnel only. Log as service, then
select:

Maintenance > Service > Calibration > Mechanical

And then the required section

14.1 Mechanical calibration

Initialize instrument.

14.1.1 Photometer

This calibration will determine the optimum reading position in the middle of each cuvette.

 Remove cuvette cover. Press F1 function or

Start button

 Use buttons or letters Q and E in keyboard until

cuvette number 3 is close to photometer
position. Use 10 steps or 1 step option as
required. Photometer position is labelled with an
arrow.

 Close cover

 Press Scan button. Instrument will scan cuvette number 3 and in Position window
will write optimum calibration value.

 Press F3 function or Confirm button.

If instrument was already calibrated, Last button will position tray where last calibration
was determined. This procedure will save time and item 3 can be skipped.

Once Start button is pressed, calibration can be aborted by pressing the Skip button.

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14.1.2 Arm and Reaction Tray

This calibration will define that tip falls in the reaction tray in the middle of the reaction
cuvette. Also, it defines the cuvette vertical position, which in turn, will define the
dispensing height. Calibration includes positioning of cuvette washer module.

 Remove cuvette cover and cuvette retainer cover.

 Press F1 function or Start button.

 Use buttons or letters A and D in keyboard until tip is close to the centre of
cuvettes. Use 10-step or 1-step option as required.

 Use buttons or letters W and S in keyboard until tip is few millimetres above
cuvette.

 Rotate tray by using buttons or letters Q and E in keyboard until cuvette number 1
(labelled with a sticker) coincides with tip position.

 Repeat steps 3 and 5 until tip falls in the middle of cuvette number 1. For better
sensitivity, use 1-step buttons. Do not fine tune vertical position at this time.

 Press F5 function or Test button for verification and then F3 function or Confirm
button.

 Loosen washer head screws. Use buttons or letters R and F in keyboard until
dryer block reaches cuvette bottom. Optimum setting is when block spring
compresses about 1 mm. Use 10-step or 1-step option as required.

 Tighten screws.

 Press F5 function or Test button for verification and

then F3 function or Confirm button.

 Shift probe horizontally until tip is above cuvette body

but outside cuvette itself.

 Use buttons or letters W and S in keyboard and 1-

step mode until tip just touches upper flat part of cuvette body.

 Press F3 function or Confirm button.

If instrument was already calibrated, Last button will position tray where last
calibration was determined. This procedure will save time and item 3 can be skipped.
Once Start button is pressed, partial calibrations can be aborted by pressing the Skip
button.

Note: Last button does not act on vertical positions. This is to prevent tip damage.

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14.1.3 Washer

Use this window to calibrate the position when the drying block goes down to a cuvette.

 Choose washer, then press Start. Verify that drying block is in position 16.

 Loosen calibrating screws. Use buttons or letters W and S in keyboard until drying
block is completely in the cuvette and it slightly bents the reaction tray to ensure
contact. Firmly adjust calibrating screws.

 Use Last to position the block to the last available calibration.

 Press Skip to cancel or Confirm to accept the calibration.

14.1.4 Arm and washing station

 Press F1 function or Start button.

 Probe will approach to the washing station from the left. Use buttons or letters A
and D in keyboard until tip is close to the centre of washing station. Use 10-step or
1-step option as required.

 Use buttons or letters W and S in keyboard until tip just touches the bottom.

 Press F5 function or Test button for verification and then F3 function or Confirm.

 Press F5 function or Test button. Probe will go up, go to the reactive position and
approach to the washing station from the right.

 Use buttons or letters A and D in keyboard until tip position coincides with the
centre.

 Press F5 function or Test button for verification and then F3 function or Confirm.

 Calibrate the tip in such way is possible to discharge a reaction directly to the
drain system.

 Press F3 function or Confirm button.

If the analyser was already calibrated, the Last button will position tray where last
calibration was determined. This procedure will save time and item 3 can be skipped.

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Once Start button is pressed, partial calibrations can be aborted by pressing the Skip
button.

14.1.5 Arm and Sample Tray

 Press F1 function or Start button.

 Use buttons or letters A and D in keyboard until tip is close to the centre of inner
sample ring. Use 10-step or 1-step option as required.

 Rotate Sample tray by using buttons or keys Q and E in keyboard.

 Repeat 3 and 4 until tip is in the centre of sample vial number 1.

 Press F5 function or Test button for verification and then F3 function or Confirm.

 Use buttons or letters W and S until tip just touches bottom of sample vial. Pull up
frequently the vial while stepping down

 Press F3 function or Confirm button. This will calibrate Primary Vial bottom
(Standard 13 mm vial).

 Use buttons or letters A and D in keyboard until tip is close to the centre of
Sample 2 position. Use 10-step or 1-step option as required.

 Rotate Sample tray by using buttons or keys Q and E in keyboard.

 Repeat 3 and 4 until tip is in the centre of sample vial number 2.

 Press F5 function or Test button for verification and then F3 function or Confirm.

 Use buttons or letters W and S until tip just touches bottom of sample vial. Pull up
frequently the vial while stepping down

 Press F3 function or Confirm button. If a different vial (paediatric) is used,

Secondary bottom is calibrated, otherwise primary and secondary bottoms
coincide.

If instrument was already calibrated, Last button will

position tray where last calibration was determined. This
procedure will save time and items 3, 4, 9, and 10 can
be skipped.

Once Start button is pressed, partial calibrations can be

aborted by pressing the Skip button.

Note: Last button does not act on vertical positions. This is to prevent tip damage

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14.1.6 Arm and Reagent Tray

 Fully remove the reagent cover.

 Press F1 function or Start button.

 Use buttons or letters A and D in keyboard until tip is close to the centre of cap of
outer reagent ring. Use 10-step or 1-step option as required.

 Rotate Reagent tray by using buttons or keys Q and E in keyboard.

 Repeat 4 and 5 until tip is in the centre of cap of reagent vial number 1.

 Use buttons or letters W and S until tip just touches cap of reagent vial.

 Press F5 function or Test button for verification and then F3 function or Confirm.

 Use buttons or letters A and D in keyboard until tip is close to the centre of inner
reagent ring vial number 25. Use 10-step or 1-step option as required.

 Rotate Reagent tray by using buttons or keys Q and E in keyboard.

 Repeat 4 and 5 until tip is in the centre of reagent vial number 25.

 Press F3 function or Confirm button.

 Repeat procedure for vial 49 (physically located as the inner split vial on position
25).

 Use buttons or letters W and S until tip just touches cap of reagent vial.

 Press F5 function or Test button for verification and then F3 function or Confirm.

 Probe will position on reagent 1. Uncap reagent 1.

 Use buttons or letters W and S until tip just touches the bottom of the vial.

 Press F3 function or Confirm button.

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If instrument was already calibrated, Last button will position tray where last calibration
was determined. This procedure will save time and one or more steps can be skipped.

Once Start button is pressed, partial calibrations can be aborted by pressing the Skip
button. Test button allows confirmation of settings.

14.1.7 Sample Tray

This calibration is intended for alignment of sample sectors into the removal area.

 Press F1 function or Start button.

 Rotate Sample tray by using buttons or keys Q and E in keyboard until zone 1 is
visible in the load area.

 Re-adjust until sector can be loaded and unloaded through the loading area.

 Press F3 function or Confirm button.

If instrument was already calibrated, Last button will position tray where last calibration
was determined. This procedure will save time and item 1 can be skipped.

Once Start button is pressed, calibration can be aborted by pressing the Skip button.

14.1.8 Reagent Tray

This calibration is intended for alignment of reagents into the

removal area.

 Press F1 function or Start button.

 Rotate Reagent tray by using buttons or keys Q and

E in keyboard until Reagents 1 and 25 are visible in
the load area.

 Re-adjust until reagents 1 and 25 can be loaded and unloaded through the
loading area.

 Press F3 function or Confirm button.

If the analyser was already calibrated, Last button will position tray where last calibration
was determined. This procedure will save time and item 1 can be skipped.

Once Start button is pressed, calibration can be aborted by pressing the Skip button.

14.1.9 Bar Code Reader

 Press F1 function or Start button.

 Install in reagent 1 position a vial with valid bar code.

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 Use buttons or letters A and D in keyboard until vial is in front of BCR window.
Use the 1-step option.

 Press button or key R in keyboard and verify if code is read.

 Repeat steps 3 and 4 until code is read. Look for the central position if code is
read in a range of positions.

 Press F3 function or Confirm button.

 Repeat procedure for reagent located in position 25.

 Install in sample 1 position a vial with valid bar code.

 Use buttons or letters Q and E in keyboard until vial is in front of BCR window.
Use the 1-step option.

 Press button or key R in keyboard and verify if code is read.

 Repeat steps 3 and 4 until code is read. Look for the central position if code is
read in a range of positions.

 Press F3 function or Confirm button.

If the analyser was already calibrated, Last button will position tray where last calibration
was determined. Once Start button is pressed, partial calibrations can be aborted by
pressing the Skip button.

14.1.10 ISE Module

 Press F1 function or Start button.

 Use buttons or letters A and D in keyboard until tip is close to the centre of ISE
loading window. Use 10-step or 1-step option as required.

 Press F3 function or Confirm button.

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 Use buttons or letters S and W in keyboard until tip touches the bottom of the
loading cup. Use 10-step or 1-step option as required.

 Press F3 function or Confirm button. System will automatically calculate the

required steps up.

 Use buttons or letters A and D in keyboard until tip is close to the centre of ISE
priming position. Use 10-step or 1-step option as required.

 Press F3 function or Confirm button.

 Use buttons or letters S and W in keyboard until tip is in the bottom of the ISE
priming position. Use 10-step or 1-step option as required.

 Press F3 function or Confirm button.

 If the analyser was already calibrated, Last button will position tray where last
calibration was determined. This procedure will save time and item 2 can be
skipped.

 Once Start button is pressed, partial calibrations can be aborted by pressing the
Skip button.
Note: Last button does not act on vertical positions. This is to prevent tip damage.

14.2 Photometer Calibration

Photometer calibration consist of automatic adjustment of gains for front, back and
reference channels. Also, energy ratios front/reference and back/reference are evaluated.

Ratios are used for absorbance calculations.

Calibrations must be performed once per month as indicated at monthly maintenance

section and/or when the lamp is changed or filters are cleaned or replaced.

Automatic Channel Ratio is automatically re-calculated once every two weeks.

When calibration is performed, error messages will be issued if gains are too high or too
low. No conditions are established on ratios.

14.3 Reagent bottles

This calibration is intended to determine the average area of bottle and bottom position,
as seen from the probes.

In each of four conditions, operator will be prompted to introduce the water volume
(measured to the start of bottle neck) and introduce the bottle with a liquid level of about 5
mm from the bottom.

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15 Barcode reader
15.1 Definitions

Closed system: An analyser intended to be used with pre-filled, barcode-labelled reagent

containers, to restrict operator's ability to use reagents obtained from sources other than
the instrument's distributor.
Open Channel: It represents a reagent position reserved to allow an user defined assay
in a closed system. This option provides some versatility by allowing a laboratory to
purchase a reagent from a source different from the supplier, if required.
Open system: a system enabled to perform tests using reagents other than those supplied
by the distributor of the analyser.

15.2 Usage of barcode features

 Samples

After pressing Place Sector for sector loading in the tray, all the sample barcodes
will be read and the samples Id will be automatically loaded.
In case that the Auto Request test of LIS is enabled, instrument will automatically
load all the required tests to be performed.

 Sectors

When placing a sector, BCR will read the sector number from the barcode located
on the sector.

 Reagents

To request a reagent loading, open the reagent tray window, right click a suitable
position and then choose change & BCR check.
Press Apply Changes to start the loading process once all the requests are done.

15.3 Parameters for barcode reader

To access configuration, enter

Data > Log as supervisor

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then press

Maintenance > Parameters > Software > BCR Tab

Tick on Samples, Reagents and Sector checkboxes to enable or disable the required
features.

Sample configuration

Use Id position checkbox to enable the trim option for the barcode readings. Define origin
(from) and length as required. (E.g. Setting from to two, means that the system will ignore
the first letter of barcodes).

Reagent configuration (open system mode only)

For the definition of information contained in the barcode string, set origin (from) and length
of each field. Do not overlap the fields.
Method / Solution BCR code: Code used as reference to identify a reagent or solution
type.
Bottle type: Identifies the type of bottle, (1=small, 2=large, 3=split), see graph below.

Reagent number: When using reagents having two or three components, this parameter
represents the number of the components for the reagent.
For the case of a split bottle, given the outer reagent number, inner reagent number is a
follows:

Outer Inner
1 2
2 1
3 1

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Bottle Id: Contains information related to the production or lot number.

Expiration: Sets date to alert when the reagent is expired.

15.4 Implementation of barcodes

Maximum length for samples and reagents barcodes, the length is up to 20 alpha-numeric
characters. For details on labelling position, see figure (Data expressed in mm).
Available codes for both sample barcodes or reagent barcodes (on open systems), are
Code 128 (NCCLS recommended), UPC/EAN, Code 39, PARAF, Tri-Optic, 2 of 5 Codes,
Codabar, Code 93, Code 11, MSI Plessey and Telepen.

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16 Service options

The following items belong only to Service manual and cannot be accessed by user.
They are protected with password. It should be introduced in

Data > Log as Service > Password

Once password is enabled follow:

Maintenance > Calibration

16.1 Lamp intensity

When Start button is pressed, a continuous reading is shown in the screen: either instantaneous bar
type plot or time evolution in a time/intensity plot.
Reading can be shown for any filter.
Use this option when re-adjustment of the lamp socket is required. In this case, maximize reading
while getting both channels as equal as possible.
By using this option, filter wheel can be stopped and returned to normal mode. This feature is only
intended for testing purposes.
Time evolution allows determining if lamp intensity variations are responsible of stability problems.
Plot scales can be varied by clicking and dragging mouse on graph. If drag ends outside graph, axis
returns to their original settings.

16.2 Filter wheel

Rotating filter wheel system requires fine adjustment of reading delays, filter by filter and for all
channels.
This is a factory adjustment and it should not be modified unless a major servicing is required (motor
replacement, sensor position adjustments, etc.)

Do not use if a filter is replaced.

1. Remove all cuvettes from light path.
2. Select to Reset delays to 20.
3. Keep normalization By channel

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4. Press Start button.

5. Adjust offset until maximum for all channels and filters is approximately in the middle of
the plot (10). This is a coarse adjustment.
6. Select Stay on filter.
7. For fine tuning use the Delay buttons, filter by filter until all three channels are as centered
as possible.
8. Press Stop button when done.

Notice: Reading is slow; it takes approximately one second to refresh plot. Make small changes and
wait for refreshed values.

16.3 Other Servicing options

When the service option is activated, other options are shown in

Maintenance > Service

16.3.1 Manual
When using Manual movements for testing purposes ensure that the parameter Manual movements
safety restrictions in Debug section is activated, otherwise tip and other components could be
damaged.
Whenever an order is issued, windows on right show low and high level communications.
When right clicking on a given communication line, Command Interpreter window is opened:

It displays description, direction, parameters, etc. which will help to debug errors related with it.
Arrow buttons allow scrolling along the communication window.

16.3.2 Communication
This screen shows the level of communications between instrument and PC.

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Upper window shows high level communications, including request and answer.
Lower window shows the low level communications.
Window to the right shows Gantt diagrams. A Gantt chart is a graphical representation of the
duration of tasks against the progression of time.
They depict dilution operations, including different modules and relative positions in a time scale.

16.3.3 Debug
Under limited conditions this option allows instrument operation, enabling or disabling trays, probes
& warning messages.
Particular care must be taken with option “Manual movements safety restrictions”.
Safety restrictions are those which put probe in a safe place before attempting movements. If
disabled, tip and other parts are at risk.

16.3.4 Parameters

Notice: Parameters cannot be modified when instrument is in use.

Filters. Wavelength definition of installed filters. There are 14 filter positions. Position 0 is always
reserved to blocking (zero) filter and cannot be modified. For filter change, write in the right window
new value and press button.
A zero value in wavelength for positions 1 to 14 means that the position is not used, regardless there
is a filter or not.

Others.
Temperature
Front and back arms. Recommended range: 40 to 43oC
Reaction Tray: 37 to 39oC
Cool tray: 7 (low) to 8 (high) oC.
Pre and post-wash
Delivered volume with pumps when anti-interfering options are in effect.
Recommended volume: 100
Recommended speed: 4320
Cuvette blank.
Limits and tolerance in the cuvette test. Tolerance refers to the allowed variation in
each individual cuvette from the initial reading before being considered dirty.
Low limit (abs): 0.090
High limit (abs): 0.1700

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Tolerance (abs): 0.030

Pumps
Parameters which define the tip wash. They are valve opening times and are
measured in milliseconds.
External wash: 750 milliseconds
System flush: 4750 milliseconds
Decompression: valve pre-opening time for pressure release purposes: 250
milliseconds.
Wear
Factory recommendation for warning on consumables expected life.
Each parameter, when surpassed, triggers a warning message. The warning message
presence does not prevent from instrument usage.
Washing station
Defines volume of water delivered in cuvette wash stations. Water is delivered in
four cuvettes at the same time, between 500 and 700 microliters in each one. The
total volume is between 2000 and 2800 microliters. Calibration is in step of
peristaltic pumps. Each pump turn corresponds to 400 steps.
ISE
Enables/Disables the option.
Time pinch valves are open. Defines delivered volume of standards A and B. Its
value must be adjusted to get a delivery of180 l.
ISE Thresholds
Define values in mVs for detection of different fluids.
Instrument Serial Number
Stores instrument Serial Number

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