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Rev. 4.

Metrolab 2300 GL

CLINICAL ANALYZER

OPERATOR´S MANUAL

September 2008

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Rev. 4.2

Manual de Uso
Version 4.00
Rev. EAD 3/7/07
Rev. Gala 10/07/07
Rev. EAD 11/07/08
Versión de soft 4.1
Rev. EAD 16/07/08 C. Doc. No. 28 Referido a C.I No. 23
Cambio de soft y hard para equiparar al V4
CE Diatron EAD 27/10/08

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Rev. 4.2

WARNINGS

1) Only connect instrument to a line complying with local or national rules


and specifications.
2) Never use instrument for a purpose other than specified by manufacturer.
(For purpose description, See Chapter 1).
3) Never turn instrument on without waiting at least 20 seconds after turning it off.
4) Do not connect monitors, printers or unauthorized cables in RS232 outputs of
instrument.
5) Do not open rear or left cover of instrument before reading specific
servicing situations described along the present manual.
6) To change lamps and other elements, follow directions included in the present
manual.
7) The use of most screen savers can affect communication between PC and
Metrolab 2300GL. Use only “Windows Curves and colors” at its minimum
speed, if a screen saver must be utilized.
8) Maintain the cover down during operation to avoid danger from moving parts
and to improve performance of the instrument.
9) This is a class A product. In a domestic environment, this product may cause
radio interference in which case user may be required to take adequate
measures.

For technical assistance, please contact local representative or directly to


factory.

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Rev. 4.2

Safety symbols used in instrument:

7
Warning: Before using read instructions in Manual

Hazardous Voltage

Ground connection

Biological Risk

Warranty is subject to the following conditions:

Trained personnel must perform installation.

Installation Checklist and Test Report must be sent to


manufacturer.

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Rev. 4.2

WARNINGS on Instrument and Laboratory practices


1) Perform daily, weekly and quarterly maintenance procedures, as specified in user
manual. Keep records on actions and dates.
2) Perform instrument tests as indicated in user manual. Any departure from
specifications should be consulted with the Service Department. Keep records on
tests and calibrations of instrument. Compare data with previous information.
3) Perform all maintenance repairs and replacements as required by manufacturer.
Elements such as drying block and tubing must be inspected daily.
4) The use of standards in every run. Factor values can be used instead of standards
if:
a) Reagent belongs to the same lot for which factor was determined.
b) Standard absorbance did not vary more than ¼ of the allowed method
variation in the last few readings.
c) Instrument did not suffer a major repair (change of filters, lamp or
photometer).and photometer) since the last calibration.
5) To ensure adequate quality control, normal and abnormal control with assayed
values should be run as unknown samples.
a) At least every eight hours
b) When a new container of reagent is used
c) After preventative maintenance is performed, or a critical component is
replaced.
6) Control results are considered valid if:
a) Control values fall within the specified range.
b) Results for controls run at the beginning and end differ by an acceptable
level of variation. An acceptable level of variation is criteria determined by
user, or control manufacturer.
7) Read all warning messages at the end of the run. Results can be totally or partially
accepted or rejected if:
a) Reagent initial absorbance values fall within specified range.
b) Energy is within range.
c) There are non-stopping instrument errors.
8) Open the error file and check for repetitive mechanical errors. If errors in
Sample/Reagent tray or Reaction tray repeatedly occur, results must be under
suspect and eventually discarded.
9) Immediately after the run check if cuvettes are dry. If not, results of previous run
are under suspicion and should be carefully controlled and/or repeated.
10) Whenever a new reagent is introduced in the system cross-contamination must be
studied. The study should be performed by using the same reaction cuvettes for
both suspected reagents, in the interfering order: first the interfering, next the
interfered reagent. Study should consist of running precision tests on new reagent
alone and in contamination condition with other reagents. Acceptance criteria must
meet normal laboratory practice.

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Rev. 4.2

Table of Contents
1 DESCRIPTIO .......................................................................................................... 11
1.1 OVERVIEW ............................................................................................................. 11
1.2 OPERATING FEATURES .......................................................................................... 13
1.3 TECHNICAL SPECIFICATIONS ................................................................................. 15
1.4 MAIN MENU ........................................................................................................... 17
1.5 INSTALLATION ....................................................................................................... 19
1.5.1 Unpacking..................................................................................................... 19
1.5.2 Instrument Setup ........................................................................................... 20
1.5.3 Software Installation and Startup................................................................. 21
1.5.4 Software registration .................................................................................... 24
1.5.5 Database settings.......................................................................................... 24
2 SYSTEM DESCRIPTIO A D DATA LOAD ...................................................... 25
2.1 METHOD SETUP ..................................................................................................... 25
2.1.1 Chemistry methods ....................................................................................... 27
2.1.1.1 Definition Page ......................................................................................... 27
2.1.1.2 Detail page................................................................................................ 32
2.1.1.3 Multipoint page ........................................................................................ 33
2.1.2 Coagulation methods.................................................................................... 35
2.1.2.1 Definition page ......................................................................................... 36
2.1.2.2 Detail page................................................................................................ 37
Multipoint page ........................................................................................................ 37
2.1.3 External methods .......................................................................................... 40
2.1.4 Calculated methods ...................................................................................... 41
2.1.5 Method development..................................................................................... 42
2.2 PRE-DILUTION ....................................................................................................... 42
2.3 TABLE OF METHODS IN USE .................................................................................. 43
2.4 REAGENT DATA INPUT .......................................................................................... 44
2.4.1 Loading individual reagents......................................................................... 44
2.4.2 Load from a tray........................................................................................... 44
2.4.3 Tray setup ..................................................................................................... 45
2.4.4 Tray modification ......................................................................................... 45
2.4.5 Reagent reservoirs........................................................................................ 46
2.5 TABLE OF PANELS: STANDARDS, CONTROLS AND PROFILES ................................. 47
2.6 LOAD OF SAMPLES, STANDARDS AND CONTROLS. .................................................. 49
2.6.1 Replicates of the same standard. .................................................................. 51
2.6.2 Load of standards for curve construction .................................................... 51
2.6.3 Additional data entry.................................................................................... 52
2.6.4 Pediatric samples ......................................................................................... 52
2.6.5 Conditional sample load............................................................................... 53
2.7 VERIFICATION OF PROGRAMMED REAGENTS AND SAMPLES.................................. 53
2.8 PARAMETERS ......................................................................................................... 55
2.8.1 Functionals ................................................................................................... 55
2.8.2 Instrumentals ................................................................................................ 56

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2.8.3 Laboratory.................................................................................................... 57
2.8.4 Maintenance ................................................................................................. 58
2.8.5 Technical ...................................................................................................... 59
2.8.6 Optics............................................................................................................ 60
2.9 IMPORT AND EXPORT TO/FROM OTHER PROGRAMS................................................. 60
2.9.1 Exchange in ASCII protocol ......................................................................... 60
2.9.2 LIMS connection through Serial Port .......................................................... 61
2.9.2.1 ASTM structure of messages.................................................................... 63
2.9.2.2 Field lengths used by instrument .............................................................. 66
2.9.2.3 Messages in LIMS operation.................................................................... 66
2.10 HISTORIC FILE ....................................................................................................... 67
2.10.1 Statistics........................................................................................................ 68
2.10.2 Plots .............................................................................................................. 69
2.10.3 Exporting results .......................................................................................... 70
2.11 CALCULATIONS ..................................................................................................... 70
2.11.1 Absorbance reading...................................................................................... 70
2.11.2 Kinetics. ........................................................................................................ 71
2.12 ................................................................................................................................... 71
2.12.1 2-point Kinetics. ........................................................................................... 73
2.12.2 Color............................................................................................................. 74
2.12.3 End Point ...................................................................................................... 74
2.12.4 Times (Coagulation)..................................................................................... 74
3 DAILY STARTUP A D OPERATIO ................................................................... 77
3.1 STARTUP SEQUENCE .............................................................................................. 77
3.2 REGISTRATION....................................................................................................... 77
3.3 WASH SOLUTIONS .................................................................................................. 79
3.4 DAILY OPERATION ................................................................................................ 80
3.4.1 Daily sample loading procedure .................................................................. 80
3.5 MEASURING ........................................................................................................... 80
3.5.1 Volume check................................................................................................ 80
3.5.2 Temperature ................................................................................................. 82
3.5.3 Reagent Integrity check ................................................................................ 82
3.6 INTERFERENCES ..................................................................................................... 82
3.7 DILUTION AND REPETITION .................................................................................... 83
3.8 STAT PROCEDURE .................................................................................................. 84
3.9 PROCEDURE FOLLOW UP ........................................................................................ 85
3.9.1 From reaction tray ....................................................................................... 86
3.9.2 From the time table ...................................................................................... 87
3.9.3 From window of Operating Status ............................................................... 88
3.10 CHOICE OF OPTIMUM CALIBRATION CURVE ........................................................... 89
4 MAI TE A CE ....................................................................................................... 91
4.1 PREVENTIVE MAINTENANCE PROGRAM................................................................. 91
4.1.1 Recommended daily care.............................................................................. 91
4.1.2 Weekly Care Recommendations ................................................................... 92
4.1.3 Quarterly Maintenance Recommendations .................................................. 92
4.1.4 Maintenance as needed ................................................................................ 93

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4.2 REPLACEMENT AND CONTROL OF WASH SOLUTION................................................ 93


4.3 PUMP TUBING AND SYRINGE REPLACEMENT. ......................................................... 94
4.4 LAMP REPLACEMENT ............................................................................................. 95
4.5 SAMPLE PROBE CARE ............................................................................................. 95
4.5.1 Calibration procedure for probe arm (Only if required) ............................. 96
4.6 CONTROL AND MAINTENANCE OF HYDRAULIC CIRCUIT ......................................... 96
4.7 PHOTOMETER AND FILTER CLEANING .................................................................... 97
4.8 DETECTOR LENS CLEANING ................................................................................... 97
4.9 INFORMATION RECOVERY. .................................................................................... 97
4.10 CALIBRATION ........................................................................................................ 98
4.10.1 Photometer ................................................................................................... 98
4.10.2 Reference .................................................................................................... 100
4.10.3 Cuvette bottom............................................................................................ 100
4.11 MAINTENANCE FORM .......................................................................................... 100
5 TROUBLESHOOTI G........................................................................................... 103
5.1 OPERATION MALFUNCTION WITH WARNING ......................................................... 103
5.2 VISIBLE FAULTS ................................................................................................... 104
5.2.1 Drop formation on probe tip after dispensing............................................ 104
5.2.2 Drop formation after wash cycle. ............................................................... 105
5.2.3 Abnormal noises. ........................................................................................ 105
5.2.4 Inaccurate Temperature readings. ............................................................. 105
5.3 INCONSISTENT RESULTS ....................................................................................... 105
5.3.1 Colorimetric methods (one or more) .......................................................... 106
5.3.2 Symptom: Low linear range. ...................................................................... 107
5.3.3 Fast kinetics................................................................................................ 107
5.3.4 2-point kinetics ........................................................................................... 109
5.3.5 Inconsistent values in automatic repetition or dilution .............................. 110
5.3.6 Coagulation ................................................................................................ 110
5.4 MESSAGES AND WARNINGS................................................................................. 111
5.4.1 Messages while not operating instrument .................................................. 111
5.4.2 Run-time errors and messages ................................................................... 114
6 VALIDATIO PROGRAM A D TESTS............................................................. 120
6.1 REQUIRED ELEMENTS. ......................................................................................... 120
6.2 DESCRIPTION OF TESTS ........................................................................................ 121
6.2.1 Energy......................................................................................................... 121
6.2.2 Cuvettes ...................................................................................................... 121
6.2.3 Cuvette dryer .............................................................................................. 121
6.2.4 ;oise ........................................................................................................... 121
6.2.5 Photometer Stability ................................................................................... 122
6.2.6 Dilution....................................................................................................... 122
6.2.7 Stray light ................................................................................................... 123
6.2.8 Simultaneous............................................................................................... 123
6.2.9 ISE dilution ................................................................................................. 123
6.2.10 Movements .................................................................................................. 124
6.2.11 Washer ........................................................................................................ 124
6.3 AUTOMATED VALIDATION TESTING .................................................................... 124

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Rev. 4.2

7 ILLUSTRATIO S ................................................................................................... 126


Figure 1. Crating unpacking sequence. ........................................................... 128
Figure 2. Front view of instrument.................................................................. 129
Figure 3. Rear view of instrument. .................................................................. 130
Figure 4. Front Panel detail. ............................................................................ 131
Figure 5. Capillary probe heater connection. .................................................. 132
Figure 6. Syringe Replacement. ...................................................................... 133
Figure 7. Hydraulic input circuit. .................................................................... 134
Figure 8. Lateral cover removal for lamp replacement. .................................. 135
Figure 9. Lamp replacement............................................................................ 136
Figure 10. Pump tubing assembly. .................................................................. 137
Figure 11. View of reaction cuvettes when set in light path. .......................... 138
Figure 12. Sample detector unit....................................................................... 139
Figure 13. Peristaltic pump tube replacement ................................................. 140

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Rev. 4.2

1 DESCRIPTION
Autoanalyzer Metrolab 2300 Version 4 is a multitask system capable of
performing 48 different tests to 48 samples in a walk-away manner.
Its purpose is to perform Laboratory Chemistry Analysis in automated and selective
form, either in routine or Stat mode. In Clinical analysis, it purpose is the In Vitro
Diagnostics.
Born as an improvement of the popular Metrolab 2300, it incorporates the latest in
robotics, computer and communication technology to render simple and reliable
long-term operation.
The Metrolab 2300GL consists of a system of modules performing specific
functions, computer controlled, and with bi-directional communication.

1.1 Overview
The system supports the following modules:
• PC/IBM compatible computer, Pentium 233 or higher, 32 Mbytes minimum
RAM memory, 20 Megs free space on hard drive, CD Rom.
• 80-column dot matrix or bubble jet printer.
• Cooled Sample/Reagent multiple tray.
• Reaction tray.
• Robot probe arm.
• Diluter.
• Photometer.
• Cleaning system.
• Level sensing systems.

Multiple Sample/Reagent Tray Loads 48 samples. Each sample can be


positioned consecutively or in any position in the tray. The system processes the
samples in increasing order, from 1 to 48.
The same tray accommodates 48 reagents; therefore, 48 single tests or 24 double
reagent tests, can be programmed for every sample.

Reaction tray. 80 reaction well capacity. If the number of programmed reactions


exceeds 80, the instrument will halt and demand reaction cuvette replacement for
specific positions, then will resume operation. This routine repeats as necessary.
The reaction cuvettes are disposable and come in strips of five units and they are
available in 0.6 cm. of path length.

Robot probe arm. The robot probe aspirates the reagent and sample, introducing
a small air gap between them, then dispenses both in an identified reaction
cuvette. The probe arm thermostats both sample and reagent before dispensing, at
0.5oC above the selected reaction chamber temperature.
It has 4 work stages: (from right to left)
1. Dispensing position.
2. Wash position.

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Rev. 4.2

3. Sample aspiration position.


4. Reagent aspiration position, reagents 1 to 24.
5. Reagent aspiration position, reagents 25 to 48 (only split reagent vials)
6. ISE delivery position

In the case of accidental probe arm collision, the system halts and signals an alarm
until the problem is cleared.
Diluter. A diluter with a 500-microliter syringe, aspirates reagent and sample
consecutively. Air gaps separate liquids to prevent early mixing and contamination.
Level sensors. When the probe aspirates samples or reagents, capacitive radio
frequency system senses liquid level and stops probe tip at the surface. The tip
penetrates the surface just enough to aspirate the required volume and minimizes
the possibility of carryover, contamination and volumetric error.
By the same means, the probe senses the level in all reagent vessels at the
beginning of the working cycle to establish if enough reagent is present for the
programmed assays.
Samples in primary tubes are used by the system, eliminating the need and risk of
sample transferring.
Impact detector. Whenever the probe tip or arm impacts a mechanical obstruction
in its path, it automatically halts, and visual and sound alarms are emitted. As soon
as the problem is cleared, the system will resume the job.
Photometer. The photometer is provided with 9-interference filters mounted in a
filter wheel, and has a double beam reference system. Wavelengths are: 340,380,
405,450, 505, 550, 600, 650, and 700 nanometers.
Light from a tungsten halogen source passes through the selected filter and a
beam splitter. One beam traverses the reaction cuvette and the other is directed
upon the reference detector. The reading is obtained as the ratio of both signals,
and the system is therefore immune to source fluctuations, exact filter positioning
or dirt accumulation on optical surfaces. This double beam design allows the
detection of reaction cuvettes in the reaction tray, and sets alarms if cuvettes are
missing or defective.
Bichromatic mode is enabled by the system. This consists of reading the sample at
two different wavelengths. The second wavelength is selected in a region where
the chromogen of the sample does not absorb. This accounts for turbidity,
hemolysis and intrinsic sample color, etc.
Mixer. There are two mixing options that can be used in conjunction: Tray shake
and mixer motor located on the head of the probe. The mixer motor has an
eccentric head that introduces a circular motion to the probe tip.
Cleaning system. In between sample aspiration, a programmable diaphragm
pump flushes the probe with distilled or de-ionized water (DI water) with
tensioactive addition. An alarm will flag when the DI water reservoir is almost
empty, or when the waste reservoir is almost full.
The consumption rate of the cleaning solution is very low.
The cleaning of the probe is enhanced by an additional automatic cleaning routine
accessed through the program with the aid of specific wash and soak solutions.

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Rev. 4.2

1.2 Operating features


Output Data File: The results remain in the Sample Table unless they are erased
or sent to the History Table. Factors for each assay and results from control sera
can also be saved in separate tables in the History Table. The History Table is
automatically erased after a specified number of days, preset through Functional
Parameters Menu.
Printout of results: Metrolab 2300GL uses all Windows printing capabilities. If
data are saved to disk, and no printout is required, set print batch parameter to
zero.
Analytical Methods: Metrolab 2300GL can store on hard disk an unlimited
number of different analytical methods. Methods can be: chemistry, coagulation,
external or calculated. Each chemistry method contains the following information:
Name: Up to 15 characters.
Test ID: 6 identification characters.
Nomenclature: A code number for identification by external software.
Brand: 15 characters for brand identification.
Type of assay:
Kinetics: Incubation and rate readings at intervals automatically pre-set.
End Point: Performs a blank reading in the reaction cuvette before
incubating the sample.
Color: Uses reagent blank. (One for each method).
Two point Kinetics: incubation and two readings at selected interval.
ISE: Ion selective Na, K and Cl determinations (Optional)
Reference:
Single point or multipoint (curve).
For single point factor and/or standard can be introduced.
Wavelength
Principal: Peak wavelength in clinical assays, wavelengths available in optic
parameters.
Bichromatic reference: For assays where serum color and turbidity interfere.
Improves precision of readings.
Sample volume: 2 to 100 microliters. (A parameter defines minimum allowed
volume)
First reagent volume: 0 to 700 µl (0.6 cm cuvettes).
Second reagent volume: 0 to 450 µl. Use 0 for single reagent assays.
The sum of sample and reagents volumes should not exceed the reaction cuvette
capacity of 700 microliters.
First incubation time.
Second incubation time: Used in double reagent methods. If this time is zero,
both reagents are loaded simultaneously.
Concentration of standards
Depending on the calculation type, system can operate with one or more
standards.
One standard is used with normal colorimetric methods. When a high
measuring range is required in systems that do not obey Beer's Law; more
standards can be used either in Curve, in non-linear mode a quadratic or
multilinear adjust.

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Rev. 4.2

Factor: If working with one standard, it will indicate the calculated factor in
accordance to concentration and absorbance of the standard. Not used in
multipoint calibration.
Initial absorbance Limits: Indicates reagent deterioration if limit is exceeded or is
below or above a specified maximum and minimum. Used with the reagent
intensity check option.
Threshold: For time readings (coagulation), it indicates absorbance change.

Limits
Low Concentration: Indicates concentration value that determines analysis
repetition when not reached.
High Concentration: Indicates concentration value that determines dilution and
repetition of analysis.
Consumption: indicates allowed maximum initial absorbance rate. Values
above it cause changes in the measuring interval and eventual repetition. Operates
only in kinetic modes.

Factor Calculation: Determines how the factor is handled. As options, a


previously calculated factor may be used, or an average between previous and
actual factor can be used, or simply use the actual factor.
Multipoint requires the use of multiple standards. They always operate in
replacement mode.
Reagent Tray: Designates a group of 1 to 48 reagent sets in the tray. The order is
an operator’s option. The position of each reagent in the tray, and the number
present are saved to memory as a “Reagent Tray.” An unlimited number of tray
configurations can be stored. It is not necessary to use all reagents in a tray.
During a work cycle, select the tray containing the required reagents. Just select
the tray number or name and its composition will appear on the screen.
Table of methods in use: is a sub-set of all methods. With a double click,
methods from this table go to selected entry in Sample Table.
Panels: they consist of sets of methods stored on a separate table. The use of
profiles saves time when data are introduced. When exported, all methods
included in that profile are sent to the Sample Table. It is normal practice to
prepare a “Hepatic profile”, a “Cardiac profile”, etc. In the Standard Table Profiles,
Controls and Standards are pre-defined.
STAT procedures: At any time, new samples can be input without interruption of
incubation times. Data can be entered via the Sample Table as “Samples” or as
“Stats.” When introduced as Samples, they are processed in the order that they
occupy in the tray. When introduced as Stats, they acquire priority over all
Samples already in the tray.

Patient input: Patient data can be entered with their corresponding assay data of
each sample. The protocol number is mandatory. The name, age, sex and terminal
are optional.
Data are:
Protocol number
Surname and name
Age
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Rev. 4.2

Sex
Terminal (used for selective output/input)
Other optional demographic data. (See Section 2.6.3)
Tests to be performed
These data will be displayed in the final report together with the assay results.

Statistics: Statistical analysis may be performed on samples, standards and


controls. They are performed through the History Table only. Levy-Jennings
diagrams are obtained and Westgard rules are applied.
Output data: Various printout formats are available. They are printed as samples
are completed. They include the Laboratory’s name, patient data, numerical data,
units and diagnostics. The export file is in Paradox or Dbase format.
Serial port communication: Data can be introduced and results returned from/to
a host computer with LIMS capabilities, through a RS232C serial port.
Transmission follows standards established in ASTM 1390 protocol.

1.3 Technical Specifications


Samples
48 positions in rotary tray
Use of primary tubes or pediatric vials.
Optional bar code reader for sample identification with 16 characters.
Sample volume programmable 2 – 100 µl
Reagents
48 positions
Reagent volume programmable:
First reagent: 0 –700 ul
Second reagent: 0 – 450 µl
Typical volume: 200 µl .
Total volume (Sample + Reagent 1 + Reagent 2) must not exceed
700 µl
Reagents can be accommodated either in 50 ml. vials or double 30
ml. and 25 ml. vials for 2-reagent methods. System also
accommodates large size vials of 70, 45 and 30 ml.
Sampling system
Pre-heater in probe to deliver reagent at preset temperature
Capacitive sensor level
Inner and outer probe washing system
Klohen TM diluter with valve assembly

Reaction tray
Mixing system by probe vibration and tray shake.
Admits 80 cuvettes of 0,6 cm of light pass
Double beam, interferential filters
Wavelengths: 340, 405, 450, 505, 550, 590, 650, 700 and 750 nm.
Bandwidth: 10 nm
Photometric range: -0.1 to 4.5 A with (referred to a 1 cm path light).
Lamp: halogen, 6 volts, 20 watts.

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Rev. 4.2

Analysis modes
End point with sample blank or reagent blank
Factor or standard
Priority programmable per sample (profile) or reagent (batch)
Calibration curves with two up to 10 standards
Automatic curve adjust
Turbidimetry
Coagulation time by turbidimetry
Fast and two-point kinetics (0 and 1st order)
Profiles, batches, STAT procedures.
Automatic time adjust and dilution with high substrate consumption,
Dilution for values above high limit.
Pre-dilution of samples if method requires it.
Automatic repetition on abnormal low values.
Quality control: Levy Jennings plots, Westgard rules
Data export and import to other programs and/or remote terminals.
Automatic backup protection.

Throughput
240 test/hour for an all end point mono-reagent profile. 190 test/hour
for a profile including 40% double reagent and 40% kinetic assays.
Measurement is defined on the basis of 150 tests and counting from
the first intake to the last dilution.

Data handling
Computer required: PentiumTM or equivalent
Minimum 256 Mb RAM (See Section 1.5.2)
Two serial ports RS232C or 1 serial port RS232C and 1 mouse PS2
Port. One additional serial port for communication with external LIMS
system.
Color monitor SVGA
Windows™ multitasking system version XP, Windows Vista
CD Rom unit and 31/2” floppy disk
Ink jet or 80-column printer.

Communication
Serial port standard communication according ASTM 1394 protocol.

Supply
85 to 240 VAC +/-10% - 43/65 Hz – 400 VA
Automatic set
Fuses: 2.5 A – FF for 220 VAC
5.0 A - FF for 110 VAC µl
Insulation: Class 1

Water consumption
1.5 ml/analysis, approximately
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Rev. 4.2

Operating conditions
Temperature range: 15 – 35oC
Relative humidity: < 80%
Pressure: 750 – 1060 hPa.
Dimensions
Width: 85 cm
Height: 47 cm
Depth: 58 cm
Weight
Gross: 80 Kg, Net instrument alone: 60 Kg.

Usage mode
Continuous

WARNING: Instrument is Installation Category II. Instrument


requires protective ground connection. Verify ground connection
before installing the instrument

1.4 Main menu


The main menu bar contains menu drop-downs for all system functions and icons for direct
access the most important functions.

Data
Methods: Analytical methods stored in memory
Samples: Table where samples, standards and controls are loaded.
Historic: All measured data can be sent to this table. Statistical calculations
can be performed on them.
Methods in Use: Table with a selected set of methods of daily use.
Panels: Table where standards, controls and profiles are pre-defined
Interferences: Sets of pairs of interfering reagents are defined.
Trays in Memory: Sets of reagents are stored in tray for easy load.
Check LIMS: Retrieval of external data.
Memory: Instrument reconnection and servicing operations
Exit: Close program.
Trays
Samples and reagents: Graphic representation of Samples and Reagents
Tray. Allows operator to visualize programmed samples, reagents, volumes,
etc.
Movements
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Rev. 4.2

Manual
Automatic: Start and stat options.
Calibrate; Photometer, mechanics, water reference, cuvette bottom. For
mechanical calibration, See the Service Manual.
Cleaning: Automatic probe cleaning procedure, purge and filling

Inspect
Communications: Contains all the communications between PC and
instrument for the last run.
Coordinates: Instantaneous values for last position of the system (Trays,
probe, read frequencies, etc)
Status: Instantaneous status of error functions.
Messages: Warnings and error condition for the system. Some of them are
also shown in “ Operating conditions” and some are in the Error log file.
Errors: Error log file. Opens in WordPad format.
Filters: Gains, zeros, frequencies and status of the 9 optical filters.
Calibrations: Gains, zeros and frequencies for all gains, not only those
selected by the system.
Volumes: Once the samples are programmed, details of needed volumes
for all reagents. Error conditions also shown.
Priorities: Order of analysis is established by instrument. It takes into
account, highest priorities for blanks, next for standards, etc.
Times: Table showing all measurements in the reaction cuvettes. Also
collects information on actual measuring times, volumes, etc. It has an
historic page where data are stored when cuvettes are blanked.
Operating Conditions: Used cuvettes, samples to dilute, time to the next,
reading, status messages.
Parameters: (See Section 2.8).
Miscellaneous
Repeat Analysis: Data of last reading are erased and Sample Tray re-
loaded.
Clean Samples: Sample Table is erased. Sample Tray must be empty.
Clean Historic: Cleans Historic Table. Requires password.
Clean Messages: Cleans the Table of Messages.
Backup: Allows creation of backup files for Historic, Methods and
Parameters.
Save Desktop: Saves settings on sizes, positions and columns for every
active window.
Print Screen: Direct printout of the active window. Shift + Print Screen
sends active window image to the clipboard.
Translator: Multi-language dictionary for all messages and screens.
Test: Instrument testing. See Chapter 7.
Test Record: Information about the use of reagents.
Help
Users Manual: Access to PDF version of user's manual.
What is new: version highlights.
About: Software version and manufacturer information.

2300GLlTIU Rev. 4.2 18


Rev. 4.2

Icons. Most of them correspond to already defined menus.

Table of Methods

Table of Samples

Samples and Reagents Tray

Reaction Tray

Barcode reading for samples and reagents

Full initialization of system

Trays are disabled to facilitate load of samples and new cuvettes.

Manual movements

Ends all procedures in progress.

Start of automatic procedure.

Volumes and priorities.

Prints active window (To clipboard con shift + icon)

Stops and resumes dispensing for Stat procedures

1.5 Installation

1.5.1 Unpacking
Instrument should be moved preferably by mechanical aid.
The instrument is packed fixed onto a wooden pallet, suitable for transportation.
In case that instrument needs to be manually moved, at least two persons should
take it from the lower wooden pallet.

With reference to Figure 1:


1. Cut clamp rings that retain crating
2. Pull up the whole crate, but leaving instrument fixed to the base.
3. Remove all accessories
4. Remove four nuts that hold instrument to the base.
5. Carefully place instrument on desktop.

If instrument is tested in distributor's premises, do not remove from base: hold on it


and reinstall crate cover to send to customer.

2300GLlTIU Rev. 4.2 19


Rev. 4.2

1.5.2 Instrument Setup


Refer to Figure 3 of this manual. There is one J 9 serial port type RS232C
connector. Use the cable provided to connect the connector to Serial Port of the
computer. If computer has J 25 type connector in Serial Port 2, use Serial Port 1 or
a J 25 male to J 9 female adapter.
If mouse is connected to PS-2 connector type, connect instrument to Serial Port 1.
If mouse is connected to Serial Port 1, connect instrument to Serial Port 2. Tighten
retaining screws.
Connect level sensor tubing of DI water and waste reservoir as indicated in Figure
3. Sensor tubing is yellow color. The waste deposit stopper has three fittings: two
for the waste hoses and one for level meter. One of them is the direct drainage of
the probe wash station. The other collects contingent waste from the dispensing
station in the reaction chamber.
The wash solution reservoir must be located at less than 0.2 meters below or
above the peristaltic pump of the instrument.
The waste reservoir must be located below the instrument, and hose SHOULD
NOT FORM BENDS that may impede drainage or overflow drain funnels.

IMPORTANT: level metering is made by means of a pressure detector device. For


proper operation, be sure that stopcock is firmly tightened.

The Mains plug must be connected to 110/220 volts, 5/10 amperes installation,
after ensuring proper fuses value of instrument that complies with local regulations
(See Section 1.3).

WARNING: Instrument is Installation Category II. Instrument requires


protective ground connection. Verify ground connection before installing the
instrument.

Computer Setup
Computer must be PC compatible, Pentium microprocessor, speed 233 MHz or
higher. Hard and floppy disks and CD Rom must be installed. Minimum free space
on hard drive must be 20 Mbytes.
for mouse) and any PC compatible printer must be installed.
Table shows OS compatibility.

Operating Version Previous Sound Minimum Recommen


system 3.0 versions requirements RAM (Mb) ded
RAM (Mb)
Windows 95 No Yes PC speaker 16 32
Windows 98 No Yes PC speaker 32 64
(1st. edition)
Windows 98 Yes Yes PC speaker 32 64
(2nd. Edition) (No for
Asiatic
versions)
Windows Yes Yes Sound card 64 128
Millennium and external

2300GLlTIU Rev. 4.2 20


Rev. 4.2

speaker
Windows 2000 Yes Yes Sound card 64 128
and external
speaker
Windows XP Yes Yes Sound card 128 256
and external
speaker
Windows Yes Yes 2 Gb 4 Gb
Vista

1.5.3 Software Installation and Startup


Install Windows Xp in the computer. Perform typical installation.
M2300GL software for Windows is provided on one CD-Rom.

Installation disk has Auto-run features that is will start installation automatically.
Should not use the auto-run capability, follow the following instructions: Double
click on My Computer on Windows desktop. Select drive D: (or E, or other drive
designated as the CD drive) and double click on

D:setup.exe

Alternatively, select START menu, RUN and enter:

D:setup.exe
and click OK.
The installation program will ask for operator’s name / company and then will
automatically install in directory

C:\Program Files\Autoanalyzer

In the same folder, icons are located for Recover and Test programs.
Install the program as follows:

Open the Windows Explorer. Locate the directory Autoanalyzer


where the program has been installed. You will find a Sub-directory with the
instrument’s name main directory:

Program Files

Autoanalyzer

Data

2300GLlTIU Rev. 4.2 21


Rev. 4.2

In this Autoanalyzer directory you will find direct access to the program and to the
Backup option. Drag the icons of these files to the desk. To do that, press left
button on the file icon and drag mouse until icon is outside the Windows Explorer’s
window and on the desktop. Release button.
In Data directory all required databases will be located.

Once program is installed, specific calibration parameters for each instrument will
automatically be installed.

IMPORTANT: Before installation, verify that CD disk number coincides with


instrument Serial Number.

NOTE: Before proceeding with instrument startup, it is highly recommended to


carefully go through the following chapters to become familiar with software and
instrument operation.

WARNING: If a dot matrix printer is used, a minimum configuration of 120 X 144


dots should be used. Otherwise printout could be incomplete.

Start program by double clicking on the program icon.

In Parameters, key-in default service password, select Technical and select


desired Port.

2300GLlTIU Rev. 4.2 22


Rev. 4.2

Verify that Movements are operative: Select Full Initialization and


all trays, arm and diluter will move and acquire their startup positions.

Perform a CALIBRATION to the instrument (See Section 4.10).

Edit the Functional Parameters. Modify the default password 12345 to any
desired alphanumeric expression. Also modify the laboratory name, address,
phone, etc.

Insert authorization code and Serial Number parameter.

Insert an empty vial in the sample tray, select Probe Down in Probe, Manual
Movements (HORIZONTAL POSITION 3) and verify that the probe reaches the
bottom of the vial. Make corrections as necessary. Verify that the probe does not
collide with any vial as it moves to all positions. If adjustment is correct, probe
should sense level with 100µl water in the vial. (See Section 4.5.1)

Verify the 5 horizontal probe positions. Calibrate if necessary. Follow instructions


included in Service Manual.

Perform a “Fill” cycle and several dispensing cycles with diluter speed set to 15.

2300GLlTIU Rev. 4.2 23


Rev. 4.2

NOTE: When new cuvettes are installed, be sure that they are free from dust
and packing material.
Perform cuvette bottom calibration. To do this, select the option:

Movements > Calibrate > Cuvette Bottom

Perform validation tests. For instructions, please refer to Section 6.

1.5.4 Software registration


For software registration follow instructions included in the Installation manual

1.5.5 Database settings


Before starting operations, check settings in database.
Using Windows Explorer, select directory:

C:\Program Files\ Common Files \Borland Shared\ \BDE

By double clicking on it execute program

BDADMIN.EXE

Select Tab of Configuration, then System > INIT


Verify that Local Share is set to “False.” If not, change accordingly.
Also, check if SharedMemSize is set to 8192. If not, change setting to 8192.
Close the window. If modifications were made, confirm the changes by selecting
Yes in the confirmation window. This window will not open unless changes are
made.
Alternatively, to execute database configuration program, in the Run menu
execute:

C:\Program Files\ Common Files \Borland Shared\ \BDE\ BDADMIN.EXE

2300GLlTIU Rev. 4.2 24


Rev. 4.2

2 SYSTEM DESCRIPTION AND DATA LOAD

2.1 Method setup

2300GLlTIU Rev. 4.2 25


Rev. 4.2

Methods are classified as follows:

1- Chemistry: These are the common clinical chemistry methods.


2- Coagulation: Turbidimetric time analysis
3- External: Methods whose results are directly keyed-in in the table of
results for printing and statistics purposes.
4- Calculated: Methods whose result is a derivation of measured
analysis.
5- Development: Continuous reading of sample. Absorbance plot for
development purposes.

The following options are available for all those methods:

Test: Automatically generated when name and brand are entered. This is formed
by the first three letters of reagent name, a dash and first two letters of Brand. The
purpose of these test ID is to simplify reagent identification when entering data.

Name: Up to 15 alphanumeric characters, designating reagent name. (Must


always be present)

Brand: Reagent manufacturer. Up to 12 alphanumeric characters. (Must always be


present). (In calculated, at least one printable character must be introduced)

Units: Up to 8 characters.

Edit
To modify method press Edit and enter password.

Print
Printout of all methods in memory

Import
Input methods from files

Next method

Previous method

+ New method

--
Erase method

Confirm method

2300GLlTIU Rev. 4.2 26


Rev. 4.2

2.1.1 Chemistry methods

2.1.1.1 Definition Page

Wavelength (nm):
Principal: from 340 to 767nm (See available wavelengths in the Optic
parameters). Always must be present.
Bichromatic: from 340 to 767 nm (See available wavelengths in the Optic
parameters). The reading at this wavelength subtracts from reading at the
principal wavelength.

Reference values:
Minimum: Input minimum reference values for men and women.
Maximum: Input maximum reference values for men and women.

Validity (in days)


Calibration
This parameter defines the number of days for which the latest calibration is
valid. The maximum allowed period is 60 days. If 0, no testing is performed.
When automatic procedure starts, table of reagents and volumes will show
the Expiration Date of each programmed reagent. Operator can choose
either to eliminate the reagent with expired calibration or continue.
Blank
Defines expiration of blank in methods. Once expired, blank will be
measured in next automatic cycle. If 0, blank will be measured in each run
(default condition). Blank reading can be forced, even if valid, when reagent
window is opened with mouse left button (See section 2.4)
Type:
End point: End point readings imply an initial reading after sample and
reagent mixing in reaction cuvette, followed by a reading performed after
the incubation time.
The advantage of this type of measurement is that concentration is
proportional to the absorbance difference between both readings and thus
compensates cuvette irregularities, reagent color and sample turbidity. This
type of measurement, combined with bichromatic reading, and the fact that
the photometer is double beam, makes measurements strictly dependent on
COLOR CHANGE as a function of time. This method is to be used when
color generation in the reaction is gradual, and is not evidenced suddenly
during sample and reagent mixing.
Calculation is simple:

Concentration = Factor * ( Afinal - Ainitial )

2300GLlTIU Rev. 4.2 27


Rev. 4.2

The FACTOR is introduced directly in the method, (method with factor), or


calculated by the instrument with the absorbance of a standard of known
concentration, (Method with standard).

The parameters are:

TYPE: End point


WAVELENGTH: According to method. Bichromatic reference can be chosen.
ABSORBANCE LIMITS: Used for reagent integrity check.
HIGH Conc.: Defines the CONCENTRATION above which automatic dilution as
needed is to be performed. According to method.
LOW Conc.: If this concentration limit is not reached, analysis is repeated, unless
limit is set to zero.
INCUBATION TIME: According to method. In two reagent methods, 1st and 2nd
time must be defined. The 1st corresponds to the time interval between reagent
dispensing and second reagent addition. The 2nd is the effective incubation time.
VOLUMES: According to sample/reagent ratio established in the analytical method,
adjust reagent volume between 0 and 700 µl, accounting for a minimum of 2µl for
the sample.
FACTOR: Assigned in accordance with method specification or previous
calculations. If operating with a standard, the factor is automatically calculated
when the standard is measured.
DIRECTION: Always ascending.

Color: For colorimetric measurements, a reagent blank is prepared for each


sample tray (batch) or a blank reading is performed in each cuvette when
reagent is added and before sample is delivered. The effective color
measurement is obtained as the difference between sample reading and
blank reading. This method is recommended when color is rapidly
developed after sample and reagent mixing in the reaction cuvette

Parameters:

IMPORTANT: All parameters, times, volumes, of Colorimetric methods are


identical to end point parameters, except for the blank origin (in cuvette or batch). If
batch mode is selected, an additional vial is used in the sample tray and only one
reagent blank is used for each analytical method for each sample batch.

Fast kinetics: Incubation and next 7 readings at 30 seconds intervals.


Slope is calculated by least squares. Linear fit and correlation factor are
output. Absorption change vs. time is measured. It applies to first order
kinetics where the concentration can be expressed as C =F *∆A/min
Where F is a factor provided by the reagent manufacturer in a direct
manner, or through a table. ∆A/min is the rate of change of the absorbance
per minute obtained directly as the slope of A as a function of time through a
correlation calculation.

2300GLlTIU Rev. 4.2 28


Rev. 4.2

Particular attention should be paid to manufacturer's indications as to the


temperature for which the factor has been calculated. Some reagents have
a constant factor and vary the normal limits as a function of temperature.
As the reaction tray and the reagent pre-heater in the dispensing probe have
the same temperature for each run, all analytical methods should be
adjusted to this temperature.
All methods should be adjusted to 37°C.
Kinetic readings are performed in seven time intervals. The first measuring
interval is 30 seconds. Consumption rate is monitored even during
incubation time. If the rate of change of the absorbance exceeds the limit
imposed by the method, the following time intervals are adjusted to variable
intervals from 30 to 5 seconds; otherwise they remain 30 seconds.
Result will always be expressed in terms of absorbance variation per
minute.
If sample concentration surpasses the High Concentration Limit, the
sample is diluted to the required volume, multiplying the final result by the
corresponding volume ratio.
If sample concentration is below the Low Concentration limit, the dilution
and measurement is repeated. The first and second readings are kept in the
Sample Table.
In the result plot, the correlation coefficient is printed. It indicates the degree
of linearity of the reaction. A correlation coefficient of 0.9 to 1 will indicate a
“linear” reaction; a value between 0.8 and 0.9 indicates a “suspect linearity”;
under 0.8 the reaction is considered “non linear”.
The Direction of the reaction must be specified according the method in
use.

IMPORTANT: A non-linear result is not infrequent in normal enzymatic values


when time intervals are small, and therefore irregular.

Method parameters that correspond to kinetic readings:

TYPE: Fast Kinetics


WAVELENGTH: According to method.
CONSUMPTION LIMIT: (According to consumption of substrate, if exceeded,
reading time is reduced accordingly.
ABSORBANCE LIMITS: Minimum and maximum initial absorbance of substrate.
LOW Conc.: Defines the concentration value at which automatic repetition will be
performed (According to method), unless limit is set to zero.
HIGH Conc: Defines the concentration value at which automatic dilution will be
performed (According to method).
INCUBATION TIME: Interval between dilution and first reading. It is eliminated if
consumption exceeds three times the consumption rate.
VOLUMES: According to the sample/reagent reaction imposed by reagent
manufacturer, scaled to a reagent volume of 200 to 300 µl and a minimum sample
volume of 2 µl. Second volume: it can be added at later time as starter.
FACTOR: According to method and temperature.
DIRECTION: Ascending or descending according method.
2300GLlTIU Rev. 4.2 29
Rev. 4.2

NOTE: The concentration limits can be used to generate automatic repetition of


reading of all samples that surpass certain value chosen arbitrarily, even if it is
within the linear limit.

Two point kinetics: Incubation and two readings. The interval is the
Kinetics 2 time.
Absorbance change is measured at a fixed time interval. The first reading is
performed after the first incubation period. The second reading is performed
at a fixed incubation time, elapsed since the first reading.
For maximum precision, if the incubation limit is greater than 0, the first
reading is obtained by interpolating between two readings: one taken 6
second before the corresponding time and other immediately after the time.
This method is used preferentially with nonlinear kinetics; for example,
Creatinine and Urea (BUN). If consumption limit is set to zero, first reading is
only one.
IMPORTANT: Nonlinear kinetics does not closely relate volumes and
concentrations. Therefore, the dilution of highly concentrated samples to
one half will produce results higher than expected. To solve this analytical
problem, reduce volumes of samples and standards.

Parameters are:

TYPE: 2-point kinetics or fixed time


WAVELENGTH: In accordance with analytical method
CONSUMPTION RATE: does not operate.
BLANK/SUBSTRATE LIMIT: In accordance with method
INCUBATION TIME: Fist incubation: time elapsed from dilution to first reading.
Interval: time interval between readings.
VOLUMES: Proportionality between reagent and sample volume must be in
accordance with original method specification.
Second volume: it can be added together the first one or at
a later time.

Volumes (microliters)
M2300GL requires small reagent volumes compared to manual methods. It
is advisable to take as reference, a reagent volume of 200 microliters, and
adapt sample volume to the recommended dilution.
For example if reagent manufacturer recommends 2 ml reagent and 50 µl of
serum, to maintain proportion, for a reagent volume of 200 µl, only 5 µl
serum will be required.
If this ratio is altered, the linear range that the manufacturer indicates for that
method will also be altered.
It is not recommended to use sample volumes lower than 2 µl. It should be
noted that if the sample exceeds the normal range, the instrument
automatically dilutes the volume to one half. This implies that sample
volume will be 2 µl, which is the minimum recommended volume, compatible
with a good precision.

2300GLlTIU Rev. 4.2 30


Rev. 4.2

Sample: 3 to 100 microliters (minimum can be 2, 3 or 4 depending on


Parameter setting)
First reagent: to 700 microliters.
Second reagent: to 450 microliters. Only used in two-reagent methods.
The sum of sample and reagents volumes should not exceed the reaction
cuvette capacity: 700 ul.
Initial Absorbance: Minimum and maximum absorbance reading of reagent
blanks. It generates check and warning messages (See Section 3.5.3)
M2300GL permits methods with two reagents, for Colorimetric, Endpoint,
Kinetic and Time Elapsed methods.
The two reagents can be dispensed simultaneously or separately in time.
Two parameters control the use of double reagents: 2nd volume and 2nd
incubation time.
2nd Volume. 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.

SINGLE REAGENT TWO REAGENT TWO REAGENT


(2nd Incubation = 0) 2nd incubation > 0)
*Dispensing of 1st Volume+ *Dispensing of 1st volume + * Dispensing of 1st volume +
sample 2nd Volume + sample sample
*1st Incubation *1st Incubation * 1st incubation
*Measurement *Measurement * Dispensing of 2nd volume
* 2nd incubation
* Measurement

For end point methods, first reading is after addition of first reagent but just
before addition of second reagent. For kinetic and 2-point methods, first
reading is after addition of second reagent.

Times (sec)
Second reagent: For two-reagent methods, time elapsed until second
reagent is added (In end point methods, reading are immediately before 2nd.
reagent addition).
Incubation: Time interval from dilution/addition to reading. In two-reagent
methods, incubation is the interval from addition of 2nd reagent to reading, in
kinetic mode, interval is from dilution to first reading, in coagulation interval
begins upon sample/reagent mixing and ends when final reading or when
Wait interval is surpassed (clot not formed).
Interval: time Interval between the two readings in two pint kinetics only.

Limits:
Low Concentration: Repeats analysis for values below this limit.
2300GLlTIU Rev. 4.2 31
Rev. 4.2

If Low Limit value is set to zero or left blank (empty) feature will not be
activated for the method.
High Concentration: Establishes automatic dilution value in Concentration
units. In dilution, the new sample volume is automatically adjusted to enter
linear range. The new factor is calculated using the volume change ratio.
Consumption: (Only for fast and two-point kinetics). While incubating, the
absorbance change in the 30 - 45 seconds interval is used to estimate
substrate consumption (depletion). If the desired level is surpassed (in
absorbance units), the reading interval is automatically varied between 30
and 5 seconds. This feature extends the reagent linear range.

Reference: (Type of calculation)


Single point
Multipoint

Single point
Factor: In methods with factor, it can be entered directly. In methods with
standard, the value is automatically calculated and set when a standard is
measured. Not used in Multipoint and cutoff methods.
Standard: Only used in methods with standard.

2.1.1.2 Detail page


Calculation
Slope
Intercept
The slope-intercept method affects the final result by multiplying all data with
a factor (slope) or adding a constant value (intercept). This system allows
expressing data in different units or comparing results with other
instruments.
Blank Absorbance
Minimum
Maximum
The initial absorbance (blank or reagent) is used with the reagent integrity
check option to warn user if reagent undergoes degradation. Once informed,
operator can replace reagent, eliminate it or ignore the warning (See
Section 3.5.3).
Mixing: There are two different mixing operations: Reaction Tray shake and probe
vibration by the use of a small motor provided with an eccentric head. Probe
vibration can be used as normal, double time and triple time. Both types of
mixing can be used together or separately. Tray shake can be adjusted by
varying three Technical Parameters. Probe mixing does not require
adjustment but can be inactive (No mixing) or with increasing length
(Normal, X2 and X3). Strong action is recommended with method requires a
low volume second reagent.

Nomenclature: Numeric Method identifier for transfer purposes.


2300GLlTIU Rev. 4.2 32
Rev. 4.2

Decimals: Number of decimals for printout and transfer of results.


Correlation minimum: acts only in kinetic methods. Defines value for
automatic dilution and repetition of analysis. Linear Correlation coefficients
lower than this parameter generate dilution and repetition.

Discard volume (ul)


First reagent
Second reagent
Reagent volume can be discarded in variable volumes from 0 to 200
microliters. Its purpose is to reduce carryover or avid reagent dilution with
wash solution. Its use is only recommended in methods were no calibration
with standard is performed or high linear range is required.
Reagents
Integrity
When enabled, system delivers reagent blank alone and compares reading
with Maximum and Minimum absorbance limits. If out of limits, system halts
and requires further action.
Blank (Color methods)
This option allows discounting blank reagent in each cuvette. Procedure is
as follows:
Exact 200 microliters of reagent are dispensed; the absorbance is measured
and next reagent and sample are dispensed in the same cuvette. The
volume of this second reagent addition is to complete the total programmed
volume. After incubation, absorbance is measured and initial absorbance
blank, subtracted.
Additional blank dispensing and measurement is performed only if reagent
integrity check is selected.
This blanking system does not support second reagent addition or sample
pre-dilution.
Minimum reagent volume is 300 µl (fixed initial 200 µl plus minimum
additional 100 µl together with the sample).
When this option is enabled, a blank is measured as a normal sample,
including incubation times. For kinetic assays, time interval is fixed to 30
seconds.

Dilution
Samples can be prediluted in any method. Operator can choose the dilution
ratio and if prediluent is either specific or generic. (See section 2.2 )

2.1.1.3 Multipoint page


When Multipoint is selected and password accepted, data on concentrations of up
to ten different standards can be introduced in the second column. An identifier
must be written in first column (Id). Calculated concentrations will appear in fourth
column (Calc.). Optionally, absorbance data can be directly introduced in the third
column. Values are updated when a new standard is read. When data are
introduced by direct write, the fifth column (St.) is empty. By pressing Exc/Inc for
EACH selected standard, it is enabled. Pressing again in the button, the standard
is disabled. For the St. column possibilities are:
2300GLlTIU Rev. 4.2 33
Rev. 4.2

Standard
disabled
√ Standard
enabled
x Standard
disabled

Curve is automatically drawn and by pressing the Print button. Curve is drawn in a
separate window and from there, printed out..
.

Multipoint selection is automatic when standards are measured. The least squares
selection is made, provided equation has not multi-valued points, negative
concentrations, infinite values, etc.

2300GLlTIU Rev. 4.2 34


Rev. 4.2

The function selector window shows in the first column the type of function, the
second indicates correlative number; the third one indicates the quality of the
function:

+ Acceptable function
* Best function
- Forbidden function

Colors are shown with the function number, together with the curve equation.
The last column shows the correlation number: the lower the value, the better the
fit.
The + and – buttons allow to introduce new standards in the curve or erase them,
permanently.

IMPORTANT:
Multilinear Function is those that joins adjacent standards by means of linear
equations. It is the default equation after measuring standards. This is the best
option if all the function fits are poor.
Concentrations are calculated as follows:

Conc. = a0 + a1* f(A) + a2 * f(A) * f(A)

Where f(A) are the functions of absorbance numbered 1 to 10, and

LOG( Conc.) = a0 + a1* f(A) + a2 * f(A) * f(A)

Where f(A) are the functions of absorbance numbered 11 to 20.


Linear function 21 corresponds to interpolation with the function

Conc = a1 * A

2.1.2 Coagulation methods

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


turbidity.
Absorbance is measured in short timed 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, above measurements start after the addition of second
reagent. The second reagent time is the interval between the initial delivery and the
second reagent addition.

2300GLlTIU Rev. 4.2 35


Rev. 4.2

2.1.2.1 Definition page


Wavelength
Principal: 405 nm unless other value is recommended by reagent
manufacturer.
Bichromatic: Not used.
Reference
Correction (sec): additive time correction in final result to let data from
turbidimetry and viscosity coincide. Can be positive or negative and is
measured in seconds.
All other parameters not used.
Multipoint (See multipoint page)
Volumes: according to method.
Sample: up to 100 microliters.
First reagent: up to 700 ul
Second reagent: M2300GL permits methods with two reagents, for
Colorimetric, Endpoint, Kinetic and Time elapsed methods.
The two reagents can be dispensed simultaneously or separately in time.
Two parameters control the use of double reagents: 2nd volume and 2nd
incubation time.
2nd Volume. 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.
Times (sec)
2nd reagent: Recommended time interval until second reagent is delivered.
Measured in minutes.
Limits
Low Concentration: Time at which determination is automatically repeated.
Wait (sec): Maximum waiting time if clot is not formed and threshold not
reached. Measured in seconds.
Threshold (Abs): absorbance level that indicates coagulation. For most
reagents, a value of 0,100 works very well.
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.
Search minimum: When this item is enabled, threshold is measured from the
minimum measured absorbance. If not enabled, reference is set to the initial
absorbance. This feature is useful because some reagents reduce turbidity after
few seconds.
From (sec.): Initial time from which threshold can linearly decrease with time.
To: (% of threshold): This parameter indicates the % of initial thresholds when the
wait time expires. If no variable threshold is desired, this parameter should be set
to 100%.

2300GLlTIU Rev. 4.2 36


Rev. 4.2

100%

to (%)

From wait time

2.1.2.2 Detail page


Calculation
Slope
Intercept
The slope-intercept method affects the final result by multiplying all data with
a factor (slope) or adding a constant value (intercept). This system allows
expressing data in different units or comparing results with other
instruments.

Blank Absorbance
Minimum
Maximum
Nomenclature: Coded method definition (Selected countries)
Decimals: in result printouts.
Temperature: For printout reference only. It does not act on instrument. (See
Functional parameters)
Discard volume (ul)
First reagent
Second reagent
Reagent volume can be discarded in variable volumes from 0 to 200
microliters. Its purpose is to reduce carryover or avoid reagent dilution with
wash solution. Its use is only recommended in methods where no calibration
with standard is performed or high linear range is required.
Additional Shake
When second reagent volume is small, (less than 40 microliters) the addition
of second reagent can produce poor mixing. The shake option will enhance
mixing. Parameters for shake are defined in Factory Parameters and should
not be disturbed, unless serious positioning problems are observed in
reaction tray. If parameters must be changed, utilize manual movements >
Reactions > Shake for optimum determination.
Integrity check.
It is also applied to coagulation methods.

Multipoint page
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 with 5 points
is enough to define a coagulation curve. Percent can be introduced in the second
2300GLlTIU Rev. 4.2 37
Rev. 4.2

column and an identifier must be written in first column (Id). Calculated percents
will appear in fourth column (Calc.). Optionally, time data can be directly
introduced in the third column. Values are updated when a new standard is read.
When data are introduced by direct writing, the fifth column (St.) is empty. By
pressing Exc/Inc for EACH selected standard, it is enabled. Pressing again in the
button, the standard is disabled. For the St. column possibilities are:

Standard
disabled
√ Standard
enabled
X Standard
disabled

Curve is automatically drawn and by pressing the Print button. Curve is drawn in a
separate window and from there, printed out..

Plot scale can be enlarged by selecting area with mouse. Return to original scale is
performed by drawing a line or a square that starts within the plot and ends in the
left side of the plot.

Return to Enlarged
original area
drawing

2300GLlTIU Rev. 4.2 38


Rev. 4.2

Multipoint selection is automatic when standards are measured. The least squares
selection is made, provided equation has not multi-valued points, negative
concentrations, infinite values, etc.

The function selector window shows in the first column the type of function, the
second indicates correlative number; the third one indicates the quality of the
function:

+ Acceptable function
* Best function
- Forbidden function

Colors are shown with the function number, together with the curve equation.
The last column shows the correlation number: the lower the value, the better the
fit.
The + and – buttons allow to introduce new standards in the curve or erase them,
permanently.

IMPORTANT:
Function 0 is multilinear, that is linear equations joining adjacent standards. This is
the best option if all the function fits are poor.
Concentrations are calculated as follows:

Conc. = a0 + a1* f(A) + a2 * f(A) * f(A)

Where f(A) are the functions of absorbance numbered 1 to 10, and

LOG( Conc.) = a0 + a1* f(A) + a2 * f(A) * f(A)

Where f(A) are the functions of absorbance numbered 11 to 20.


Linear function 21 corresponds to interpolation with the function

Conc = a1 * A

2300GLlTIU Rev. 4.2 39


Rev. 4.2

Essentially, this is a parabolic type equation fit, with different functional


substitutions.

2.1.3 External methods

Methods can be introduced directly on the system and results written in the
sample. This enables to get results from other instruments and get a single
printout included in the chemistry methods and also perform statistical analysis and
storage of them.

2300GLlTIU Rev. 4.2 40


Rev. 4.2

Once the method is defined, with the button of Results, they are written in the
“Correction of results” window and from there, passed to the Sample table

2.1.4 Calculated methods

Formula definition
Method assignment

Several calculations can be performed on the results. They can be combined in


any formula, as desired. Terms in the formula are arbitrary: you can design
Cholesterol as A, CHOL, Cholesterol or whatever you want, provided that the
selected variable is assigned to a method stored in the Table of methods.
The assigned methods can be combined in a formula.
Examples are:

A/G ratio: Albumin/(Total protein- Albumin)


LDL: Cholesterol – HDL – (Trygliceride/5)
Risk: Cholesterol/HDL
Etc.

Calculated method are assigned to a patient as a separated method. If all terms


required in the formula are measured for a given sample, the calculation is
performed, the result shown in the Table of Samples and printed out.

2300GLlTIU Rev. 4.2 41


Rev. 4.2

2.1.5 Method development


This feature is used when a record of absorbance against plot is required. Method
includes most of the parameters of any regular chemistry method, but its result is a
set of plots shown in the multipoint page.
Samples are listed in a table and when selected, plot is shown.
Development method option will be visible only if option is enabled with
corresponding Technical Parameter.

2.2 Pre-dilution
Sample can be pre-diluted before analysis. This feature can be useful for any
method but it is particularly important in turbidimetric and immunoenzimatic assays.
In Details of methods the pre-diluted ratio is incorporated.
Also, the diluents can be of generic type that is the same for several methods as is
the case of physiologic solution or can be a specific diluent for a given method.
If generic is used, the box labeled as exclusive should not be checked.
Pre-dilution is performed in the first empty position in the reaction tray, with a total
volume of 300 microliters. Intake of pre-diluted sample is performed immediately
after pre-dilution.

When generic pre-dilution is used, diluent is accommodated as reagent 24. If


exclusive is used when reagent is loaded it will be loaded in the next available
position, after second reagent, if present. Positions can be modified at will, except
generic diluent.

Dilution
ratio 1+N

Check when specific


diluent for the
method is used

Generic
diluent Specific
diluent

2300GLlTIU Rev. 4.2 42


Rev. 4.2

IMPORTANT: the pre-dilution 1:N means a total volume of 1+N = 300


Sample volume is 300/N .

WARNING: Pre-dilution is a method feature. In consequence, it affect standards,


controls, standards and stats. Therefore, factors calculated with non-diluted
standards must be re-run. If pre-dilution is applied to methods without factor,
multiply manufacturer’s factor by dilution ratio.

2.3 Table of Methods in Use


This table contains methods currently in use. Its purpose is to save time loading
methods to patients.
There are two advantages for its use; first, it is a sub-set of all methods in memory;
second, it is only necessary to double click to incorporate a method, without the
need of pressing “+”, “Test” and Method selection, which is the normal procedure
when loading directly from the method data base.

To access the Table of Methods in Use proceed as follows:

For each new desired method, press the “+” key; next, click on the “Test” button.
The method selection window will be displayed. Click on desired method. Press the
“+” key and repeat procedure for all methods that are to be included in the table.
At any later time methods can be added, replaced or removed. Use the symbols
“+” and “- “to edit methods.
When erasing methods a warning “Delete record?” will be displayed.

2300GLlTIU Rev. 4.2 43


Rev. 4.2

2.4 Reagent Data Input


Loading of reagent data in the working tray can be individually entered or imported
from a pre-defined tray already stored in memory. At any time, reagents can be
entered, removed or replaced. If a Stat sample requires a reagent not previously
loaded, it can be accommodated in any free position or replace any already used
reagent.
Reagents can be placed in single or double reservoir. If the double is not checked,
it is assumed that the reagent will be single and will occupy the full position from 1
to 25 in the corresponding position from 25 to 45 will not be available.

2.4.1 Loading individual reagents

1) Select
reagent
position

3) Confirm

2) Double click on
desired reagent

2.4.2 Load from a tray


Select the desired tray, press Export to tray.
For export procedure to take effect, the reagents in Sample and Reagent tray must
be blanked.

2300GLlTIU Rev. 4.2 44


Rev. 4.2

2.4.3 Tray setup


The procedure for the definition of a tray is to enter all desired reagent data in
Sample and Reagent tray as explained in 3.4. Next, select the tray menu and press
Import from tray.
Then chose a new name for the defined tray. You can use it at any time by the
procedure illustrated above. From the tray menu you can modify, add, remove or
replace reagents in any already defined tray.
Notice: The number included in any tray is for internal use, and cannot be
modified.
When a tray is defined in the Sample and Reagent Tray Menu, the second reagent
position in a two-reagent method is automatically defined.

2.4.4 Tray modification


The way to modify a tray is to export it to Sample and Reagent Tray Menu,
modify it as desired, and re-export. It returns as “Imported” tray, and can be
renamed at will.
To delete a reagent entry, locate the mouse pointer over it, hold down the Shift key
and click the left mouse button. A pop-up dialogue box will appear. Left click in the

2300GLlTIU Rev. 4.2 45


Rev. 4.2

Test entry field. The reagent menu will drop down. Click again in the blank entry
field (it will be highlighted in blue). Click OK and the reagent entry will be deleted.

Forcing Blank
button

1) Select
Reagent to 2) Press Shift + left
eliminate button 3) Confirm

2.4.5 Reagent reservoirs


Reagents can be accommodated in different vials:

1. Single vials, 50 ml volume.


2. Split vials:
20 ml which fits in positions 1 to 24
30 ml which fits in positions 25 to 48

2300GLlTIU Rev. 4.2 46


Rev. 4.2

30 ml
Pos. 25 to 48

20 ml
Pos. 1 to 24

For use of split reservoirs, before introducing them, the position itself must
be defined as “split”.
To do that, left click on the desired position and check split box.
Once split, reagents can be loaded in either one of the components.
3. Sample vials inserted in regular reagent vials with the neck previously cut.
They admit up to 4 ml volume. A circle in the corresponding vial sector
indicates the use of this option. The Full Size option must not be checked.

If a double reagent is loaded in a split position, components 1 and 2 will be


accommodated automatically the first in 30 ml vial and the second in 20 ml vial.
Second reagent is marked with a black corner in the occupied position.
NOTE: If double reagent method is loaded in a non-split position, the first reagent
will occupy the selected position and the second reagent the first available position,
starting from position number 1.

2.5 Table of Panels: Standards, Controls and Profiles


This table contains the data of standard and control samples of current use in the
M2300GL. The procedure for defining standards and controls in a separate table
saves time, as the table has to be stored only once. If data are not reviewed, they
are simply exported to the Sample Table and from there, to the tray.
Tabs in the Table are color-coded as defined for samples: Green/red correspond to
profiles, yellow to controls blue to standards.
To enter data in the table, proceed as follows:
Open it from main menu. (When opened from Sample Table, it is not in
Edit mode)

2300GLlTIU Rev. 4.2 47


Rev. 4.2

1) Define a name. This name can be changed in the sample table, but for
Standards and Controls, it is advisable to always keep the same name
because statistics will be performed in the Historic database over samples
with equal name. When exporting profiles, name must be changed in
sample table and replaced by the patient’s protocol number.

3) For each defined sample, load the corresponding methods. They can be
loaded directly or using the Table of Methods in Use. For each new desired
method, press the “+” key or the arrow down and open a new cell; next, click on
the “test” cell. The method selector

will be visible. Click on it and select the desired method. Press the “+” key and
repeat procedure for all methods that are to be performed to the sample.
To load from Methods in Use, press the corresponding button, and double click on
the desired methods.

4) For Standards, in the column “Concentration”, enter the assigned


concentration value, in the same units that were defined in the method,
EXCEPT IN MULTIPOINT METHODS.

5) For control samples define, in the Min and Max columns, the lower and upper
target values, also in the units defined in the method. Include also Lot Number
and Expiration Date.

6) For profiles, no value is introduced.

All the samples exported to the Table of Samples can be modified there before
they are sent to the tray. Also, methods can be eliminated or replaced.
When transferred to the Sample Table, standards corresponding to a calibration
Curve produce consecutive entries corresponding to all standards. They carry the
same name but include a dash (“-“) followed by the standard identifier.

It is useful to define, in a commercial control sample, all the methods included in it.

2300GLlTIU Rev. 4.2 48


Rev. 4.2

When measuring, export to the Sample Table and erase all methods not being
tested in the run. For multi-standards, i.e. commercial sera with defined
concentrations, the same routine should be applied.

IMPORTANT: When concentrations are defined within a method, it is not


necessary to complete the corresponding columns in the Table of Standards.
Nevertheless, if a value is written in the Table, this has higher priority and replaces
the value included in the method. It is customary to introduce in the method the
values of aqueous standards when they are part of a kit. If a serum calibrator is
used, its values are introduced in the Table of Standards.

2.6 Load of samples, standards and controls.


To input samples, proceed as follows:

Select with
double click

Open Table
of Methods
in Use

1) Enable new sample input.


+
2) Key in the protocol number, name, sex, age and
terminal. Protocol number must always be present; other data
are optional.

M. in Use 3) Open the table of Methods in Use combined with the


Table of Panels.

Double click over all the desired methods in the table of Methods in Use or the
Panels from the lower part of table. Alternatively, you can export profiles directly

2300GLlTIU Rev. 4.2 49


Rev. 4.2

from the Table of Panels. (See below the same procedure for controls and
standards).

4) To input standards and controls, proceed as follows:

Panels When pressing this key, the correct tab selection will open.

Select the desired standard.

5) Repeat procedure 1 to 4 for all the samples.

To tray Once all desired samples are on table, press key “To tray” and
samples will be sent to tray.

6) Select the desired standard/s and then press To Tray to send to tray.

Automatic select

7) Repeat procedure with control samples already defined in the Table of Panels.
Press the button of Panels in the desired section (Samples, Standards, Controls).
In Samples and Stats, Table of Panels opens in Profiles, in Standards opens in
Standards and in Controls opens in controls. You can export as many samples as
you desire, even repeating the same sample.
Controls and Standards are automatically selected by double clicking on the Name
and are transferred with its name. For samples, profiles are transferred without
name and to a pre-selected sample name or protocol.

2300GLlTIU Rev. 4.2 50


Rev. 4.2

When panels are selected, listing of components is shown. Default condition is with
all components checked and all are selected. Operator can chose only part of the
panel to be measured.

8) From the Table of Samples export standards and controls to tray. Pressing the
button To Tray does this.

Important: When samples are exported to tray, they occupy the first free positions
starting from vial 1 position. If you export the samples first, they will occupy the first
positions. If you export the standards first and then the controls, they will occupy
the next free positions. Standards have the highest priority; therefore, they will be
measured first regardless their positions. Samples and controls have the same
priority; therefore, they will be measured in the order the positions they occupy in
the tray.

2.6.1 Replicates of the same standard.


The system admits up to 3 replicates of the same standard, all sipped from the
same vial. In order to measure replicates, data must be loaded through the table
of panels and not directly in the Table of Samples.
When defining standards in the Table of Panels, the last column indicates the
number of replicates. Options are nothing (null), 2 or 3. Nothing or null means just
one measurement.
Samples for all replicates are sipped from the same vial.
The average of absorbances is used for calculation of the factor.
Nevertheless, one or more replicates can be disabled and the factor is
automatically re-calculated. When a method with replicated standard is selected, a
window with all data pops up.

If standards and samples are measured in the same run, averaged calculated
factor will be applied.
It is strongly recommended that if the replicate procedure is used, standards
be run separately. This way, factors and replicates can be analyzed and
outliers discarded.

When a new run is started, the table of replicates is erased and it will not be for
averaged absorbance correction..

2.6.2 Load of standards for curve construction


For Curve methods, the procedure for constructing a calibration curve is as
follows:
1. Define calibration curve within the method as indicated in 2.1.1.3 and 0. Be
sure to include for all standards the identifier (id) and concentration. Use
numeric, increasing identifiers. Number of standards cannot be edited. If it
must be varied, satart the lod of entire table again.
2. Open the Table of Panels in Edit mode (from Data in Main Menu) and
select the Tab of Standards. Define for the calibration curve a Name and
select method. DO NOT INTRODUCE CONCENTRATION. Close table.
2300GLlTIU Rev. 4.2 51
Rev. 4.2

3. Open the Table of Samples, select Standards, press the button Panels
and double click on the desired Standard name. A set of entries, one for
each standard will be generated. Each one will contain the corresponding
concentration. In order to distinguish standards, the Id is added to the
standard’s name In order to distinguish standards, the Id is added to the
standard’s name. Id must be numeric. Introduce the desired number of
replicates of each standard.
4. Transfer to the tray.

IMPORTANT: If standards in multipoint calibration are defined in the Table of


Samples instead of through panels, the instrument software might crash.

2.6.3 Additional data entry


When arrow is pressed in Table of samples, additional data can be introduced.
They refer to patient data, location, sample definition, status, etc.

There are some fixed data but some variable fields.


The variable fields Note and observations can be used for introduction of Inspector
data, Diagnostic, and other references. Same data can be viewed in Historic file
although cannot be modified.

2.6.4 Pediatric samples


There are two types of samples: Normal and Pediatric.
The normal samples are aspirated on the surface of a primary tube or any other
vial. In that case, the needle touches the sample’s surface and penetrates a preset
amount of steps. The sample is defined as pediatric by entering a “p” or a “P” in the
first column of the sample table. When defined as pediatric, needle will not stop at

2300GLlTIU Rev. 4.2 52


Rev. 4.2

the sample surface but will descend all the way down to the position indicated by
Technical parameter “Pediatric bottom”. This feature must be used when the liquid
level does not exceed 5 mm, otherwise, the needle will become wet and
contaminated.

2.6.5 Conditional sample load


When transferring samples, standards or controls to tray, operator has the
opportunity of selecting only those desired samples and not the whole table. After
To Tray is pressed, selector will be visualized:

Selector is the correlative number and not the Sample ID. This way, there is full
control on the desired samples and ordering.

2.7 Verification of Programmed Reagents and Samples


When clicking the right mouse button while pointer is on a selected reagent, vial
size can be reprogrammed, and reagent replaced even when instrument is
operating. Left button displays required volume for all reactions and the measured
volume in microliters.
When left button is pressed on every colored sample vial, sample protocol
identification is displayed. Sample can be replaced. With Shift + left button, sample
can be erased.

When right button is pressed, a list of programmed methods for selected sample is
shown.
Sample types (outer wheel) are color-coded:
Green Sample
Blue Standard
Yellow Control Sample
Red Stat

2300GLlTIU Rev. 4.2 53


Rev. 4.2

Right button
Left button

Right button
Left button

2300GLlTIU Rev. 4.2 54


Rev. 4.2

2.8 Parameters
Parameters are divided into two categories: those that are accessed by the user
(Functional, Laboratory and Cycles), and those only accessible to technical service
representatives (Factory, Technical and Internal).

2.8.1 Functionals
Options:
1. Time priority for reagents: Order delivery is set so longer incubation times
are delivered first and shorter delivery times last.
2. Enable cuvette washer: Not operative
3. Enable samples barcode reader Not operative
4. Enable reagents barcode reader: Not operative
5. Reagent integrity: enables/disables the use of reagent integrity check
option.
6. Enable LIMS: allows using communication with host computer through
serial port RS232C.

7. Enable ISE: Not operative


8. Tip wash notification: When this parameter is checked, instrument will
stop before the tip wash operation at the end of the automatic cycle. If not
checked, automatic cycle will proceed to the end. If this option is used, do

2300GLlTIU Rev. 4.2 55


Rev. 4.2

not put samples in the defined position for cleaning and rinsing solutions. In
any case, if solution/s are not present, system will stop with warning.

Various:
10. Print batch: Indicates how many samples are printed together when
completed. If value is set to zero, no printout is produced; printout can be
generated after run. If the value is one, every sample is printed in a separate
sheet, when completed.
11. Samples expire: Samples are kept in the Sample Table this number of
days. After that, measured valid data are passed to the historic file, and
pending or questionable data are erased.
12. Historic expire: The historic file is kept in memory the number of days
indicated by this parameter. Every day, the oldest data that exceeds this
value are erased.
13. Abbreviation for Male: For other languages in which “Male” does not start
with M, the initial letter must be introduced here.
19. Minimum absorbance for Standards: Whenever a standard is read, a
factor is calculated, if the absorbance is too small or in kinetics the
absorbance variation is too small, a considerable error can be generated. If
absorbance or absorbance variation is smaller than this parameter, the
factor stored in memory is used. The default value is set to 0.020.
20. Sample batch: Set of samples processed together. All methods are applied
to this set before starting dilution of next batch.

2.8.2 Instrumentals
Wash and diluent positions:
1. Wash (Sample 1 to 48) : position in which wash solution will be placed.
Position corresponds to Sample vial position.
2. Rinse (Sample 1 to 48): position in which rinse solution will be placed.
Position corresponds to Sample vial position.
3. ISE Urine diluent ( R: 1 to 24): Not operative
4. ISE cleaning ( R: 25 to 48) Not operative
5. Sample pre-diluent (R: 1 to 48): This is the Generic sample-pre diluent
solution. Dilution of samples can be performed with a specific diluent or a
generic, common to many or all methods which require pre-dilution.
Temperature:
6. Overall working temperature can be fixed to Room, 30 or 37°C.

Various:
10. Number washes in interferences: When an interfering sequence is
detected, this is the number of additional intermediate washes. A value of
zero produces intermediate wash with the interfered reagent. (For details,
see 3.6)
11. Max. Eliminated Cuvettes: Parameter that defines how many dirty cuvettes
can be discarded.
2300GLlTIU Rev. 4.2 56
Rev. 4.2

2.8.3 Laboratory
1. Language: Spanish, English, Portuguese, Chinese, Russian and Tai are
the options. Use “English” for all other options.
When selecting in Main menu > Miscellaneous > Translator, the table
with all messages in Spanish, English, Portuguese, etc. are shown, divided
in categories. By completing the corresponding column, the software will be
automatically translated.
Notice: In order for the translation to be effective, the program must be
closed and re-started.
2. Key or password: Safety system to prevent general users from changing
data, methods or parameters without owner’s authorization. To modify it, the
original password must be introduced. Default factory value is 12345.
3. Laboratory: User data will be included in all printouts.
4. Terminal: For each different user or section, a Terminal number can be
defined. This number is bound to patient data and allows printouts or
exports by terminal. This is the basis of the multi-user function.

2300GLlTIU Rev. 4.2 57


Rev. 4.2

5. Printout type
The system has four printout options.
In Functional Parameters the mode selection determines which printout is
performed while system is operating: 1. Detailed for user, 2.simplified for
patients, 3.Hospital I, 4.Hospitals II.
Modes 1, 2 and 4 utilize the internal Printer report program.
Mode 3 (Hospitals I) uses Microsoft WordPad program.
Compact. Only names and results.
The WordPad program must be configured according the printer being used.
The margins should be between 5 and 10 mm for portrait orientation of paper
and around 30 mm for landscape orientation of paper.
The print batch is automatic set to 3 for Hospitals I option. If paper orientation
is selected as landscape, print batch will be automatically set to 2. Other
printing options follow the “Print Batch” parameter setting.
If paper is selected in landscape orientation, print batch should be set to 2.

2.8.4 Maintenance
For explanation and use of the pump, syringe and tubing counters, see Section
4.3.

2300GLlTIU Rev. 4.2 58


Rev. 4.2

2.8.5 Technical

Options:
1. 2nd. Reagent Priority. When enabled, 2nd. reagent addition has higher
priority than any other operation.
2. Show Development methods. Enables/disables access to development
methodologies.

Port:
3. Port: Serial Port to be used in computer. Usually, it can be 1 or 2. If PS2
Mouse port is used, instrument can be connected in port 1.
Absorbance of cuvettes:
4. Dirty cuvette Absorbance: This value in absorbance units allows for
distinguishing between empty reaction cuvettes, used and/or filled cuvettes.
The value must be selected by taking readings of at least 80 cuvettes and
adding 0.020 to the highest value.
5. Tolerance: Not operative

2300GLlTIU Rev. 4.2 59


Rev. 4.2

2.8.6 Optics
Filters. This table includes the definition of 9 filters. Preset wavelengths are 340, ,
405, 450, 500, 550, 600, 650, 700 nm and 767 nm. They can be replaced by any
wavelength in any position except for filter 0, which cannot be removed. It also
includes absorption of water for each filter. It is used as reference for true
absorbance reading. (See 4.10.2 )

Water absorbance. The value is automatically introduced in table when


reference calibration is performed. (See Section 4.10.2). Data are adjusted
to a 1cm path light.

2.9 Import and export to/from other programs


The Metrolab 2300GL can exchange data with other programs with two different
protocols. One is its own ASCII protocol. The other is a standard Paradox
database system. With the last option, data can be exchanged between different
terminals equipped with the same Metrolab 2300GL software, in a true Multi-user
option.
In addition, Serial Port communication allows receiving data and sending results to
a Host computer equipped with LIMS capability.

2.9.1 Exchange in ASCII protocol


Files to be imported in the ASCII option must have an extension “.ana” and the
following structure:

One line per patient. Fields are separated by semi-colons. A carriage return (CR)
and line feed (LF) must be at the end of each patient (0D, 0A).
2300GLlTIU Rev. 4.2 60
Rev. 4.2

Each line must contain:


Sample number or protocol: up to ten alphanumeric characters
Sample type: One character: N: normal; P: pediatric. A blank is admissible.
Patient name: Up to 30 alphanumeric characters.
History number: Up to 12 alphanumeric characters
Age: Three numeric characters.
Sex: One character: M, F or blank
Number of tests: One or two numeric characters.
Test code: Six alphanumeric characters. The first character must be a letter. It
corresponds to method Test ID.
Also, three numeric characters are admissible. They must correspond to
Nomenclature included in method.
If code has less than six characters, system will match first three letters with first
three letters of methods name included in “Methods in Use” table.
Different types of tests can be mixed in the same input.

Example: 2345;N;Cartell J.;1287645; 033;M;3;COL-Wi;GLU-Bi;URE (CR)(LF)


3;;Estevez;;;;5;GLU;174;AUR;GPT;GOT(CR)(LF)

Notice: Sample number or protocol, number of test and test ID are


mandatory; the others are optional but all the semi-colons must be present

To import data, press import button in Sample Table and next select the desired
.ana file.
When file is imported, samples are shown in Sample Table and keep their original
terminal number. Other data can be added manually. Import button is inactive in
the Standards and Controls tables.

Data are also exported in semicolon delimited ASCII files with res extension or
comma delimited with CSV extension.

2.9.2 LIMS connection through Serial Port

Host ANALYZER
Computer

Serial Port #2 Serial Port #1

Instrument
Computer

2300GLlTIU Rev. 4.2 61


Rev. 4.2

Lims connection is performed through a standard Serial Port RS232C. Serial port
must be other additional to these used for connection with instrument.

Communication parameters are defined in the parameter section of the Analyzer:

LIMS operation is enabled by checking the corresponding box in Functional


Parameters.
If LIMS is enabled and no Serial port device is present in the instrument PC, an
error message will be visible:

2300GLlTIU Rev. 4.2 62


Rev. 4.2

In this case, either install Serial Port or disable LIMS option until serial port is
installed.

All low-level communication, error detection and framing are strictly based on
ASTM low-level communication protocol.
High-level communication follows ASTM 1394 protocol in all what is pertinent.
Communication components will be described later.
System is established in such way that external host computer requests analysis
and results. Instrument sends back results and error messages.
The communication scheme is as follows:

Request of
analysis
Host Buffer
Computer
Stand-by
for delayed
Data are acceptance
accepted
Request Results ??
of results are sent
No
Yes

Historic
Table Performed Table of
analysis Samples

2.9.2.1 ASTM structure of messages.


The following tables contain the part of information included in ASTM 1394
adopted here. Host can send many fields but only those included in the present
tables are processed.

Header record (level 0)


Field name ASTM Host Instr. Comment
ID
Record type 1 X X Always H. Starts every message. No
ID delimiter between first and second field
Delimiter 2 X X Field, repeat and escape delimiters.
definition
Sender name 5 X Instrument ID
or ID Software version 1.0
2300GLlTIU Rev. 4.2 63
Rev. 4.2

Version No. 13 1394-97


Date and time 14 (X) From YYYYMMDDHHMMSS.
of message

Message terminator record (level 0)


Field name ASTM Host Instr. Comment
ID
Record type ID 1 X X Always L. Ends every message. No
delimiter between first and second field
Sequence 2 X X Always 1. One terminator per message.
number
Termination 3 (X) (X) N or missing: normal termination
code E: unknown error
I: no information available from last query

Patient information record (level 1)


Field name ASTM Host Instr. Comment
ID.
Record type ID 1 X X Always P
Sequence 2 X X Running number within message. Starts
number with 1
Practice 3 (X) (X) Patient ID. NULL patient is allowed.
assigned.
Patient ID
Patient Name 6 (X) (X) Patient Name. The whole name should be
given here as a string of up to 30
characters. All others will be ignored
Birth date 8 (X)
Physician ID 14 X X Doctor. 30 characters.
Patient known 19 X Diagnostic. 10 characters.
or suspected
diagnosis
Location 26 X X Section ^ Bed

Test order record (level 2)


Field name ASTM Host Instr. Comment
ID
Record type 1 X X Always O
ID
Sequence 2 X X Running number within patient
number information. Starts with 1
Specimen ID 3 (X) (X) Sample protocol. If omitted, blank will be
used.
Instrument 4 (X) Internal correlative number used by
specimen ID instrument.
Universal Test 5 (X) (X) ^^^Test ID. Will accept only those

2300GLlTIU Rev. 4.2 64


Rev. 4.2

ID identifiers as defined in the table of


methods. Host MUST use these
identifiers. Multiple ID, separated by
identifier, are admitted.
Specimen 6 X Structure YYYYMMDDHHMMSS
collection date
Specimen 8 X Type 1: Serum, 2: plasma, 3: urine,
descriptor 4:CSF, 5:other

Result record (level 3)


Field name ASTM Host Instr. Comment
ID
Record type ID 1 X Always R
Sequence 2 X Running number within test order. Starts
number with 1
Universal test 3 X ^^^Test code as defined in the Table of
ID Methods in the instrument
Data or Result 4 (X) If result is not “Done”, no entry will be
available in the Historic Table, from where
data are retrieved.
Units 5 X Units as defined in the Table of Methods.
Result range 7 X N: Normal
flags A: Anormal
Result status 9 X P: Preliminary
F: Final
X: Cancelled
P: Pending
Date/Time test 13 (X) (X) Structure YYYYMMDDHHMMSS. No
is completed value if test is not completed.
Instrument 14 X Instrument ID as defined in the Translator
identification entry that corresponds to “Autoanalyzer”

Request information record (level 1)


Field name ASTM Host Instr. Comment
ID
Record type 1 X Coded as Q.
ID
Sequence 2 X Always 1
number
Starting 3 Patient Id^Sample Id, or all
Range ID
Universal test 5 (X) ^^^Method ID or all
ID
Beginning 7 (X) Structure YYYYMMDDHHMMSS.
Request
Results, Date

2300GLlTIU Rev. 4.2 65


Rev. 4.2

and time
Ending 8 (X) Structure YYYYMMDDHHMMSS.
request of
results, Date
and time.

2.9.2.2 Field lengths used by instrument


Field Length in characters
Instrument type
Instrument ID
Software version
Date and time of message 14
Patient ID 10
Patient name 30
Date of birth 8 (?)
Patient sex 2
Specimen ID 14
Instrument specimen ID 14 (?)
Test ID 6
Specimen collection date and time 14
Clinical information 20
Section ID 18
Data of measurement 8
Units 8
Reference ranges Low 6, High 6
Data/time test completed 14
Date/time beginning request 14
Date/time ending request 14

2.9.2.3 Messages in LIMS operation


Data transmission is fully independent from instrument operation. Operator’s
attention is called only when data are pending from analysis in the buffer table and
ready to be passed to the Sample Table:

2300GLlTIU Rev. 4.2 66


Rev. 4.2

If the answer is yes, data are passed to the Table of Samples and will be ready for
analysis. If the answer is NO, they will be on hold in the buffer for later retrieval.

If one or more Test identifiers sent by host are not present in the table of Methods,
a warning message will be generated:

All other analysis will be transmitted to buffer table


If missing method/s are added to the Table of Method, the next host transmission
will complete missing data.

2.10 Historic File


Once samples are completed, they can be permanently stored in the Historic file.
From the Sample Table, when the “To Historic” button is pressed, all completed
data are transferred. They are also erased from the Sample Table at this time.
Nevertheless, when tests from a patient are pending, these will remain in the
Sample Table, whereas completed ones will be transferred to the Historic file.
Data from patients, STATS, Standards and Controls are stored in different historic
tables.
Filter
Data can be filtered following different criteria:
Sample Id, Name, number range, date range, last samples. All these criteria are
consecutive and exclusive. You can select name and from them a range number or
the last number.
For sample Id and name, simply click on it and it will be shown in selector window.
Once the selection is chosen, press Filter button and the action will be performed.
To de-select filtering, simply press the “un-filter” button or go out of the selected tab
and return (for instance pass the controls to samples and return to controls).

2300GLlTIU Rev. 4.2 67


Rev. 4.2

For names and Patient Id the selection can cover a range with dummy symbols:
With exact name, selection is on all records that match name exactly.
With a letter (or letters) followed by an asterisk, all records that start with that letter
(or letters).
If no name is selected, this field will not operate on the selection.
If no range number is selected, selection will operate over the whole historic file.

2.10.1 Statistics
Statistics is performed over the already filtered fields.
Statistics can be performed for different samples and periods: time interval, last
data, and from one sample number to another.

The sample number is an internal correlative number that is shown in a light green
column. This number cannot be modified because it is used in all databases.
The typical statistics report includes plot and data table:

Average, SD and CV are included. Dotted lines indicate +/- 1SD and +/- 2 SD.
For control samples, the prefixed range is displayed as a gray band.
An arrow located in the lower part indicates data outside the Westgard rules.

2300GLlTIU Rev. 4.2 68


Rev. 4.2

2.10.2 Plots
Results corresponding to kinetic readings can be plotted on an absorbance vs.
time diagram. This plot can be obtained either in the Historic Table, the Sample
Table or in the Times Table.
Information about linearity factor (linear correlation coefficient), initial substrate
consumption, etc. is also provided.

2300GLlTIU Rev. 4.2 69


Rev. 4.2

2.10.3 Exporting results


According to different selection criteria, results can be exported.
Menu is similar to the Statistics menu. In addition, results can be selected by
terminal, user, section, operator, etc.

IMPORTANT: In all data transfer, samples, STATS, controls and standards are
considered as different categories. As an example, if the entire historic file is to be
transferred, four different transfers must be performed. If results are modified,
modifications only affect the opened table.

2.11 Calculations

2.11.1 Absorbance reading


Absorbance is read from Photometer Status for both channels: Sample and
Reference. Readings are either Monochromatic or Bichromatic.
Additional required data are: Frequencies for each channel and filter, measured
against air. Absorbances for water blank, measured for each filter.

Abs = (Ref. Freq – 0_Ref) / (Sample Freq – 0_Sple) * Channel Ratio – Water
Reference.

Ref. Freq and Sample Freq.: Correspond to the actual measurement, as can bee
seen in the table of communications.

Reading Photometer answer:


Reference: 87079
Sample: 81168

2300GLlTIU Rev. 4.2 70


Rev. 4.2

Channel ratio and Zero correspond to Filter calibration


Water reference corresponds to Blank reference calibration.

2.11.2 Kinetics.
The used calculation method is based on a least squares linear (0 order) fit.
Data are taken at the following times

Abs_0: Approximately 30 seconds after dilution


Abs_1: 15 seconds after Abs_0 reading.
Abs_2: Specified incubation time after dilution
Abs_3: Nominal 30 seconds after Abs_2 reading
Abs_4: Nominal 30 seconds after Abs_3 reading
Abs_5: Nominal 30 seconds after Abs_4 reading
Abs_6: Nominal 30 seconds after Abs_5 reading
Abs_7: Nominal 30 seconds after Abs_6 reading
2.12
Actual reading times are recorded as To, T1, T2, T3, T4, T5, T6, T7.
If a second reagent is delivered as starter, all times are recorded with origin in
T2Reag time.

For consumption or depletion limit, the following formulae apply:

Abs_1 – Abs_0
Cons. = ----------------------- X 60
T1 – T0

If consumption is greater than Consumption Limit (CL) included in method, which


is expressed per minute. then

CL < Cons < 1.4 * CL Reading interval decreases linearly to 5 seconds.


1.4 * CL < Cons < 1.7 * CL Incubation time is not respected and reading
starts at 45 seconds
1.7 * CL < Cons Sample is diluted

If consumption is less than 0.015/min reading interval is increased to one minute.


Between 0.015/min and 0.025/min reading interval is linearly decreased from 60 to
30 seconds.

When dilution is required, there is an initial approximate result calculated as:

C = Cons * Method Factor

Analysis is repeated with a sample volume reduced with the volume factor.

New method factor is:

2300GLlTIU Rev. 4.2 71


Rev. 4.2

Method Factor (Reagt. Vol. + Sple Vol)


New method factor = -------------------- X ----------------------------------
DF (Reagt. Vol. + Sple Vol/DF)

If new consumption is still above CL, analysis is completed but error flag Cons.
Limit is established and published in the Table of Samples. Samples with such
condition cannot be passed to historic file.
When complete analysis is performed, the following least square formulae apply:

Sy = ΣAbs_i for i = 2 to i = 7

Sx = ΣΤ_i for i = 2 to i = 7

Sx2 = Σ(Τ_i * T_I) for i = 2 to i = 7

Sy2 = Σ(Abs_I * Abs_I) for i = 2 to i = 7

Sxy = Σ(Abs_I * Τ_i ) for i = 2 to i = 7

n = 6 (number of readings included in calculation)

Regression slope A1 is:

Sx * Sy - n * Sxy
A1 = -------------------------
Sx * Sx - n * Sx2

Calculated concentration is

C = Method Factor * A1

For diluted samples:

C = New Method Factor * A1

Linear regression coefficient (LRC) is evaluated as follows:

Num# = n * Sxy – Sx * Sy
Den1# = n * Sx2 – Sx * Sx
Den2# = n * Sy2 – Sy * Sy

Num#
LRC = ---------------------------

2300GLlTIU Rev. 4.2 72


Rev. 4.2

SQR( Den1# * Den2#)

This coefficient is published as “Linearity” in kinetic plot and compared with


Correlation Min. (CM) in Functional parameters.
Its value can vary from zero (total random distribution) to 1 for full linear correlation.
If CM is set equal to zero, this dilution option becomes inactive; otherwise, the
following dilution condition applies:

CL/2 < LRC < CM Dilution Factor = 2 (DF=2)


LRC < CM/2 Dilution Factor = 4 (DF=4)

New factor is calculated as above.

2.12.1 2-point Kinetics.


The used calculation method is based on linear calculation.
Data are taken at the following times

Abs_0: 6 seconds before incubation expires


Abs_1: when incubation expires.
Abs_2: Nominal “Kinetics 2” value after Abs_2 reading, expressed in seconds.

Actual reading times are recorded as To, T1, T2.


If a second reagent is delivered as starter, all times are recorded with origin in
T2Reag time.

The following calculation applies:

(Abs_2 – Abs_1*)
C = Method Factor * ------------------------- * TKinetics_2
T2 – T1

Where Abs_1* is the result of interpolation between A1 and A0 to the exact time
T1.
The Method Factor can be given as part of the method or calculated with a
standard. If measured with a standard of concentration Co, is

Co * T2 – T1
Method Factor = -----------------------------------------------
TKinetics_2 * (Abs_2 – Abs_1*)

In two-reagent methods, absorbances are measured after the addition of second


reagent.

2300GLlTIU Rev. 4.2 73


Rev. 4.2

2.12.2 Color
Color readings are made by subtracting sample reading from reagent blank
Concentration is calculated as follows:

C = Method Factor * ( Abs_1 – Blk)

Where Blk is the absorbance reading corresponding to reagent absorbance,


measured in an independent cuvette or in the same cuvette, depending on the
chosen method.
The Method Factor can be given as part of the method or calculated with a
standard. If measured with a standard of concentration Co, is

Co
Method Factor = ------------------------------
( Abs_1 – Blk )

2.12.3 End Point


End point readings are made by subtracting sample reading after incubation period
(Abs_1) from initial reading immediately after dilution (Abs_0).
Concentration is calculated as follows:

C = Method Factor * ( Abs_1 – Abs_0)

The Method Factor can be given as part of the method or calculated with a
standard. If measured with a standard of concentration Co, is
Co
Method Factor = ------------------------------
( Abs_1 – Abs_0 )

Where Blk is the absorbance reading corresponding to reagent and absorbance,


measured at the initial time.
In two-reagent methods, Abs_0 is taken just before addition of second reagent

2.12.4 Times (Coagulation)


After mixing or second reagent addition, sample is located in front of the light beam
and absorbance measured every 1/10 of second.
There are three parameters that define a coagulation method: Threshold, Wait
and Correction.
Reading scheme is as follows:

2300GLlTIU Rev. 4.2 74


Rev. 4.2

Sample or starter
reagent is delivered
at time To

Absorbance is read
Time is recorded:
T-To

Yes
Is Abs >
Threshold?

Wait 1/10
second
Result is calculated
as No
T - To + Correction

Yes Is T-T0 >Wait?

Reading is
aborted. No
No coagulation
and valid result.

2300GLlTIU Rev. 4.2 75


Rev. 4.2

2300GLlTIU Rev. 4.2 76


Rev. 4.2

3 DAILY STARTUP AND OPERATION

3.1 Startup Sequence


• Turn on instrument.
• Turn on printer.
• Turn on monitor.
• Turn on computer.
To turn off, close all applications and Windows, and then proceed in inverse order.
To turn instrument on, set lever switch in front panel to position “1”. The switch
lights up.
Turn ON printer. Verify there is enough paper for the daily job.
Turn ON monitor, green pilot light should be on.
Finally turn ON computer. Verify no diskette is inserted.
At the end of the cycle, monitor will display the Windows desktop screen.
Double click on the Autoanalyzer icon.
After a few seconds the optional Init menu will be displayed:

Init procedure will perform the following tasks:


• Complete mechanical initialization
• Temperature setting
• Lamp test
• System filling
• Syringe purge

IMPORTANT: Once software is registered, Registration form will not be shown


anymore. For registration details and procedure, see Section 3.2.

After initialization and eventual Registration, Main menu will be shown:

3.2 Registration
Software included in the instrument must be licensed.
2300GLlTIU Rev. 4.2 77
Rev. 4.2

Procedure is as follows:
1. Connect instrument first and next start program. The following window
should appear

2. The red installation code will appear in the window, written in red color.
3. This code must be sent to factory by mail to:
autoanalyzer2008@hotmail.com
4. In return, you will receive a registration code that must be introduced in
the window, at the earliest opportunity. In the meantime, instrument can
be freely operated for a trial period of 60 days by pressing the key
Continue >>.
5. If instrument is not connected, the Registration window will not be shown
and the program can be freely used in “off-line” condition. Status will be
seen in the main menu title bar.

The following remarks must be taken into consideration:

1. License is for one particular computer and one particular instrument. If


computer is changed or instrument CPU replaced, a new Registration
code will be necessary. Trial period starts again in 60 days.
2. Once the instrument is connected, trial period will start, regardless if
instrument is used or not or software is used off-line only.
3. The number of re-installations for a given instrument is limited. Do not
attempt to install and operate instrument from more than one computer.
4. The number of off-line installations is unlimited.

2300GLlTIU Rev. 4.2 78


Rev. 4.2

WARNING: Be sure to transmit the license code correctly when


using fax: use letters ARIAL BOLD size 24.
To prevent errors, either write also number in words and replace 0
(zero) with # and O (letter O) with @.
You will receive back an answer as follows (example):

A#1I-UKSE-L17K-#74@-F36I-XW97
This code only is formed by capital letters {A…Z}, numbers {1…9}
and 3 special characters { @ # - } and must be introduced only
once exactly as sent, without spaces and respecting capitals.
Be aware that you should distinguish between 1 (one) and l (letter ).

IMPORTANT: If Register window is not shown and operation is offline even


with instrument connected, check communication parameters and re-start
program. See section 2.8.5.

3.3 Wash solutions

Instrument requires a continuous supply of DI water with a tensioactive component


added.
This tensioactive is Triton X-100 or similar, in a concentration of 20 ppm v/v. For
best results, utilize 2 ml per liter of Solution 3, Cat. No. VA0003SL
For cleaning purposes, concentrated Cleaning and Rinsing solutions are required
at the end of each run.
Washing solution consists of a solution of 30 g/l of Sodium Hypochlorite in water
and rinsing solution consists of tensioactive Triton X-100, 0, 2% v/v in water.

2300GLlTIU Rev. 4.2 79


Rev. 4.2

For best results use Solutions 1 and 2 respectively, included in kit Cat. No.
VA0000SL

3.4 Daily Operation

3.4.1 Daily sample loading procedure


Before attempting to load samples, it is advisable to follow the following steps:
1) Define the set of reagents to be used.
2) Program all methods according to manufacturer's instructions and/or
methods provided by M2300GL.
3) Define the set of standards to be used.
4) Define the control samples to be used.
5) Program the most common methods in the “Methods in Use” table as
outlined in Section 0.
6) Calibrate the instrument. Calibration is automatic if not performed within 15
days. Follow the recommended directions (Section 4.10).
Daily:
In tables of data:
1) Load the Table of Samples with patient data.
2) Transfer to sample table the required standards and control samples.
3) Export all samples, standards and controls to the tray.

In the instrument:
1) Perform daily preventive maintenance as indicated in section 4.1.1
2) Check all sample and reagent positions. Verify that reagents are uncapped
and free of foam at surface.
3) Check for enough cleaning and rinsing solutions in positions 47 and 48.
4) Perform a manual filling.
5) Check if probe capillary tube is in proper shape.
6) Check if there is enough wash solution in container and if waste reservoir is
empty.

Table of Table of
Panels Samples
To Tray

Table of Methods in
Use

3.5 Measuring

3.5.1 Volume check.


When automatic procedure is started, several tests are performed: reagent
volumes, absorbances of reaction cuvettes and temperature.

2300GLlTIU Rev. 4.2 80


Rev. 4.2

Volumes are measured by touching the liquid surface with tip and calculating the
stopping position. To avoid contamination, internal and external tip wash is
performed.
At start, the table of volumes will open showing required and previously measured
volumes.
At the end, if any error occurs, the window will open again showing reagent
conditions.
The operator can choose to remove the reagent from the tray by selecting and
pressing corresponding button or to add a sufficient quantity of it. If error condition
is not eliminated, test volume will be repeated.

By clicking the Key icon button or the Movement and Automatic tabs, the
measuring process is started.
All reagents in use are displayed in the Table of Volume Analysis.
The table contains:

Test ID: Method identification.


Samples: Number of samples that use any particular reagent.
VolNec1: Required volume for reagent 1 of method, in microliters (µl).
VolNec2: Required volume for reagent 2 of method, in microliters (µl).
Reag1: Tray position of reagent 1.
Reag2: Tray position of reagent 2, when applicable.
VolMeas1: Remaining reagent 1 volume, from previous analysis, in microliters (µl).
VolMeas2: Remaining reagent 2, volume from previous analysis, in microliters (µl).
Errors:
(?): Reagent programmed in samples but not present in tray. If no corrective action
is taken, tests will not be performed at this time but will remain in the sample table
and in the tray. Observe that positions are not defined.
(X): Reagent present in the tray but not necessary, or insufficient volume. No
action should be taken at this time. The volume will be measured anyway, and
corrective action can be taken at a later time, if necessary. To continue, press the
Continue button. To eliminate entry, press the Eliminate Reagent button and
once corrective actions have been taken, start the entire procedure again.

2300GLlTIU Rev. 4.2 81


Rev. 4.2

Integrity check is enabled by Functional Parameter “Integrity check”.

3.5.2 Temperature
When system starts, temperature must be within specifications, otherwise the
following message will be shown:

The read value indicates difference with pre-set value. When temperature reaches
the correct range, message disappears and operation continues.
If after 15 minutes temperature is still erroneous, a warning message will be shown
and system halts.

3.5.3 Reagent Integrity check


Once reagent blanks are delivered the following window may open:

Reagent blanks for tests with defined integrity check are delivered and absorbance
evaluated against blank limits included in the corresponding method.
Appropriate buttons can Eliminate, Ignore or Repeat reagents whose absorbance
is out the specified limits.

3.6 Interferences
M2300GL has the capability of handling reagent interference or incompatibilities.

2300GLlTIU Rev. 4.2 82


Rev. 4.2

This is done by defining in the Table of Interferences the two incompatible


reagents, being the second, which interferes with the first. When both reagents are
in the table, the system will try to prevent diluting in consecutive order and, if this is
impossible, an additional probe wash will automatically be programmed.
For each new interference data to enter, press the “+” key; next, click on the “first”
cell. The method selector will be visible. Click on it and select the desired method.
Click on the “Second” cell and repeat procedure.
If other interferences are to be entered, press the key “+” and repeat the
procedure.

At any later time interference data can be added, replaced or eliminated. Use the
symbols “+” and “-“to include or exclude entries.
When erasing data a warning “Delete record?” will be shown.

IMPORTANT: If the Technical Parameter Number of washes in interference is set


to zero, intermediate additional wash will be performed with the interfered reagent.

The action of interference control system is threefold:


1. If two consecutive reagent deliveries match the restrictions included
in the table of interferences, the ordering in delivery will be changed
and non interfering reagents will be delivered consecutively.
2. For instruments with automatic cuvette wash system enabled, system
will reorder delivery so no delivery will occur of an interfered reagent
if interfering reagent was delivered in the same cuvette in previous
use.
3. If there is no way to apply criteria established in 1, then extra washes
described before will be applied.

3.7 Dilution and repetition


M2300GL dilutes samples in any of the following situations:
1. For any method, if final result exceeds the High Concentration Limit which
is part of the “limits” section in the Methods table. This limit is in
concentration units and in general corresponds to the linear limit established

2300GLlTIU Rev. 4.2 83


Rev. 4.2

by the reagent’s manufacturer. When this limit is surpassed, the dilution is


repeated but with a smaller amount of sample.
This limit can be modified under two circumstances:

if automatic result confirmation is required when result exceeds a given


value and when the sample-to-reagent ratio is altered.

In the sample table, the message “linear limit” will be displayed in the
column corresponding to dilution status. This message is also shown in the
time table. After dilution, the message will still be displayed, but the result
will be replaced if the second reading is higher than first. If the second
reading is lower than first more than 10%, a “questionable” message will be
displayed. In this case result is not passed to the Historic file and must be
repeated by user.

2. For fast kinetic methods, if initial consumption rate exceeds about 1.7 times
the consumption limit. This limit is part of the “limits” section in the
Methods table. For consumptions between 0.9 and 1.7 times the
consumption limit, the reading interval is linearly reduced between 30 and 5
seconds

3. For two-point methods, when initial consumption rate exceeds the


consumption limit if this is not set to zero.

4. For fast kinetic methods, when linear regression coefficient is below the
“Correlation Min.” parameter located in the Functional Parameters.
Whenever the slope is calculated, a linear regression coefficient is also
estimated. If all readings fall in a perfect straight line, the coefficient is 1. For
random readings the coefficient is zero. Kinetic readings should exhibit a
linearity better than 0.8. To leave this option inactive, set the parameter to
zero.
5. Instrument repeats without dilution if Concentration value falls below Low
Conc. Limit except when its value is set to zero.

3.8 Stat procedure


The Metrolab 2300GL software is based on Windows multi-tasking system, taking
full advantage of this operating system.
Sample input while the instrument is operating, can be performed in four steps:
1) Enter patient and sample data in the Sample Table.
2) Export data to Tray.
3) Stop dilutions while physical samples are loaded to the Sample and Reagent
tray.
4) Resume dilutions.

Samples can be entered in the Table of Samples as Samples or as Stat


Samples. The only difference is a matter of priority. Normal samples are read in
increasing position order (except standards), from vial 1 to 48.

2300GLlTIU Rev. 4.2 84


Rev. 4.2

Stat samples are diluted with priority with respect to other samples but always after
Standards.
Before exporting to the Tray, it is advisable to inspect Tray and check for empty
positions.
Only samples with numbers that coincide with free positions will be exported;
therefore, before exporting samples, you should free positions in the tray by
erasing samples already completed. They are easily visualized in the tray as
displayed on the screen, because they are marked with one diagonal black line.
The order in which they are transferred, is the order of their increasing protocol
numbers. They will occupy the free places in the increasing positions from 1 to 48.

Stop
Resume

Once the samples are exported, stop dispensing by pressing corresponding button.
The dilution in progress will be completed, then the sample tray will be halted and
the sample vials can be replaced and/or added.
IMPORTANT: The Reaction tray will continue working and measurements and
incubation times will be preserved.
Before resuming dilutions, check the sample positions carefully. Click left button
over each sample to verify protocol number.
Samples introduced as Normal will be shown in green; samples introduced as Stat
will be shown in red.

When sample check is completed, press the Resume button.


A new volume check will be performed. If new reagents are needed for the recently
incorporated samples, they must be added to tray in an empty position. Also, if new
reagents require blanking, it will be automatically performed at this time.
Reagents already used and not required in future samples will not appear in the
Table of Volumes. They can be replaced if more room is necessary. When a
sample is pending for dilution, the required volume will still be in Table of Volumes.
Stat samples are stored separately in the Table of Samples and in the Historic
Table but they are printed out together with other samples.

3.9 Procedure follow up


System operates in automatic mode but procedure can be followed from different
windows.

2300GLlTIU Rev. 4.2 85


Rev. 4.2

3.9.1 From reaction tray

When mouse is clicked over each cuvette, on the left side all data is displayed.
Colors are coded according to wavelength. White is used for UV reactions.

Dashes over the cuvettes correspond to the following situations:

Reading is completed

Sam Sample with pending dilution

Clear When measurements are to be started from cuvette 1, click on


Clear and all samples will be erased.

Wash While not in automatic operation, this button enables all used
cuvettes in the tray to be washed.
2300GLlTIU Rev. 4.2 86
Rev. 4.2

IMPORTANT: When 80 reactions are completed and/or new cuvettes are placed,
reaction tray must be blanked.

3.9.2 From the time table


Each new dilution generates a new entry in the table. It corresponds to the reaction
cuvette whose number is located on the left column. Test, class, type and filter
columns, etc., correspond to method in use for the selected dilution. Protocol ID
corresponds to the sample being diluted.

Other columns give the following information:

Class: Sample, standard, control. For blanks there is no indication of class.


Repeat: Indicates cause of dilution when necessary: linear limit, linear regression,
high substrate consumption.
Volume: Is the sum of reagent and sample volume. In dilution is the only indication
of the new used volume.
Status: Done, In progress.
Priority: Each sample has a priority. In absence of other condition, the higher the
vial position (from 1 to 48), the lower the priority. This means that samples are
processed in order from position 1 to 48.
This order is altered by the following conditions:
a) Order of samples: Blanks, Standards, Stats, Samples, Controls.
b) If Batch is different from 1, the first batch is processed, then next batch, etc.
c) If Time priority is chosen, the order of reaction is rearranged, in order to
minimize measurement time.

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Rev. 4.2

Result: Absorbance units for Color and Endpoint reactions, and absorbance
change per minute for Kinetics.
Abs0, Ab1, Ab2, etc.
In Color there is only one reading: Abs1
In Endpoint there are two readings: Abs0 (initial) and Abs1 (final).
Concentration is related to the difference Abs1 – Abs0.
In 2-point Kinetics there are four readings: Abs0, Abs1, Abs2 and Abs3.
The interval Abs1 – Abs0 defines the consumption rate. The interval Ab3 –
Abs2 defines the measurement rate.
In Fast Kinetics there are seven readings: Abs0, ....Abs6. The interval Ab1
– Abs0 defines the substrate consumption rate; the readings Abs2, ...Abs6 are the
readings used to calculate slope by least squares.
T0, T1, T2, etc.: actual reading time. The zero is set to the dilution time.

Button “Historic”: When cuvettes are blanked or washed, data are erased from
the table and stored in the Historic cuvette table. Data are stored in this table for
the amount of time indicated by the "Samples expire" parameter.

3.9.3 From window of Operating Status

Operative Error and


Status status display

This window shows current status:


Reactions Pending: Number of reactions to be dispensed.
Reactions in Progress: Indicates the number of samples already diluted but not
read yet.
Last reading also refers to samples already diluted.

The status bar indicates if instrument is in automatic, manual, calibration or


preparation mode, etc.
The Message window indicates the last operational or error message.
Bars indicate in graphic mode current status and number of used cuvettes.

2300GLlTIU Rev. 4.2 88


Rev. 4.2

3.10 Choice of optimum calibration curve


Single point methods does not require further analysis, except the acceptance or
reject of replicates.
For multi-point methods, analysis requires some additional detail.
Once analysis is finished, absorbances should be written in the corresponding
column in the Table included in method.
The optimum function is indicated in the column adjacent to the function's name
with an “O” symbol and blue color; other suitable functions are marked with a “+”
symbol and green color. Non valid, multi-valued functions show no symbol and
drawn in red color. Column to the right shows total least squares error. The smaller
its value, the better is the curve fit.
One or more curve points can be temporarily eliminated with Exc/Incl button.
Recalculation is automatic.
The following observations are important:
1. ID values must be correlative, increasing numbers.
2. Concentrations must be ordered in increasing way.
3. If the number of standards is varied, procedure must be repeated from the
beginning.
4. It is recommended to measure curves one at a time.
5. If several curves are determined at the same time for different analytes, all
must have the same number of standards.
6. It is recommended to measure standards not together with samples but
rather in a previous run, otherwise system will select multi linear function as
default.

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Rev. 4.2

2300GLlTIU Rev. 4.2 90


Rev. 4.2

4 MAINTENANCE

4.1 Preventive Maintenance Program


Scope: To familiarize operator with maintenance program of Metrolab 2300GL, as
recommended by manufacturer.
Applies to all instruments manufactured after 05/01/94, (see serial number).
Some items are not present in instruments manufactured prior to 09/01/95, and
should be incorporated by Manufacturer’s Technical Service when contacted by
client.

Requirements: The Maintenance program includes the following procedures:

*Daily care.
*Weekly care.
*Quarterly care.
*Maintenance as needed.

Operator will also find in this section:

*Cleaning and Adjustment procedures


*Controls and Diagnostics
*Quarterly Maintenance Form

4.1.1 Recommended daily care


Recommended operations should be performed at the start of every shift or on
demand.
Purge hydraulic system by selecting Movements, Clean, and Fill. During process
look for:

*Presence of bubbles or air gaps in system.

Air gaps and bubbles should be flushed, if present, during the filling operation. 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?

To solve problems, see Section 4.6: Control and maintenance of hydraulic system.

*Leakage in peristaltic pump.

2300GLlTIU Rev. 4.2 91


Rev. 4.2

Replace pump tubing even if cycling time is not reached. See Figure 10

* 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.

* Inspection and cleaning of probe

Important: Perform all automatic cleaning cycles required by the instrument.

*Remove solids from tip with a cotton swab soaked in Solution 1. Dry with lint-free
tissue.

4.1.2 Weekly Care Recommendations


* Repeat daily maintenance procedures.

* Empty and clean waste reservoir, including stopper and tubing

* Clean drain funnel in wash station. Use Sodium Hypo chlorite Solution 1 and
rinse with water.

* Clean reagent/sample tray by wiping it with mild detergent and water.


Rinse with tap water and let dry. Do not heat to dry. If desired, dry with a
towel or lint-free tissue.

* Clean instrument table top with a moistened cloth. Do not use organic solvents or
acids.

* Refill DI water reservoir and eliminate leftover.

* Execute a Wash cycle from the Cleaning menu.

4.1.3 Quarterly Maintenance Recommendations


*Optical Filters cleaning.
Before cleaning, perform a Calibration selecting the option from the Measuring
Menu and entering security code. Keep a printout for data comparison.
Proceed as in Sections 4.7 and 4.8.
Perform the calibration cycle after any optics cleaning and/or adjust.

2300GLlTIU Rev. 4.2 92


Rev. 4.2

* Replace DI water aspiration tube.


PVC tubing should be replaced, as fungus and algae formed may clog system. A
quarterly basis for replacement may seem short, but microscopic formation may
have already started.

*Cleaning of DI water reservoir. Clean reservoir, stopper and electrodes with


Sodium Hypo chlorite Solution 1. Rinse with abundant tap water followed by DI
water. Replenish DI water reservoir and perform at least three filling cycles.

4.1.4 Maintenance as needed


Must be performed when instrument indicates the need of corrective action, or
when operation anomalies are encountered, relative to maintenance:

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


Proceed as in Section 4.6.

*Message indicating pump tubing replacement. Replace tube and confirm with YES
in the corresponding display. Section 4.3

* Message indicating syringe replacement.


Replace syringe and enter YES on display. If syringe is replaced outside
corresponding menu, the syringe counter should be reset to zero. Proceed as for
tube replacement in pump, resetting the counter to zero.

*Message indicating washer pump replacement.


Replace pump at earliest opportunity

4.2 Replacement and control of wash solution


The Metrolab 2300GL washes the sample probe between sample aspirations,
requiring approximately 1 ml of DI water for each performed test. The DI water is
pumped up from its reservoir and is disposed into the waste reservoir, both
provided with the instrument. Both reservoirs have electronic level sensors.

Wash reservoir EMPTY.

Continue?

If volume is not sufficient, this message appears after initialization. It does not stop
instrument operation. As enough DI water is still present, the run can be completed
before refilling the reservoir. If no water is added, message reappears before next
run.
When the waste reservoir is full, a message is shown:

2300GLlTIU Rev. 4.2 93


Rev. 4.2

The preceding paragraph applies to this case as well.

4.3 Pump tubing and syringe replacement.


The pump tubing has a pre-fixed number of cycles for replacement. When that
number is surpassed, a message will be shown:

This message means that operation will not necessarily be interrupted. At the
earliest opportunity the replacement must be done.

Maximum
number of
cycles

Latest
replacement

Reset
button
Actual s
number
of cycles

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.

2300GLlTIU Rev. 4.2 94


Rev. 4.2

The same procedure is valid for syringe replacement. (See Figure 6).

4.4 Lamp replacement


The user can easily perform lamp replacement by following these instructions:

1. Turn off and unplug instrument from Mains. Remove right lateral cover by
removing the screw that hold it in place. (See Figure 8.)

2. Remove the four screws that hold protective grid. The lamp will be visible (See
Figure 9). Remove the thumb screw that fix lamp holder to photometer body.
Unplug lamp cable from connecting plug, (press small lever at side of plug to
disengage).

3. Install a new lamp holder with pre-focused lamp in. Reset screws and tighten.
Plug in lamp connector. Do not touch lamp bulb. If touched accidentally, clean
with lint-free cloth or tissue paper and alcohol.

4. If lamp bulb has a protective envelope, remove it. Reinstall grid, lateral cover
and fixing screws.

5. Start instrument in the order mentioned in Daily Startup and Operation.


Perform a calibration cycle. To do so, enter Movements menu and then select
Calibrate.

6. Open Inspect and then the Filters window. Compare obtained readings with
previous calibrations. Take note of gain settings for each filter. If values differ from
previous in 3 or more gain steps, contact Technical Support. Observe in the
Status column if any Gain is too high or too low.

4.5 Sample probe care


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.

A cleaning cycle must be performed when indicated. If protein deposits are seen
on the tip, remove gently with a tissue paper.

NEVER USE ABRASIVE MATERIAL: THE DELICATE PTFE COATING


WILL BE DAMAGED.

If the probe tip is defective, remove cover of probe arm, loosen setscrew that
retains the needle and pull it up. Install new probe. Tighten setscrew connector
fitting and cable and repeat procedure outlined in 4.5.1.

2300GLlTIU Rev. 4.2 95


Rev. 4.2

4.5.1 Calibration procedure for probe arm (Only if required)


Probe arm calibration is made through:

Movement > Calibrate > Mechanical

Access is restricted to Service personnel and the description of procedure is in the


Service Manual.
4.6 Control and maintenance of hydraulic circuit
Correct hydraulic system operation is essential to obtain consistent and
reproducible results.

Malfunction symptoms are:


1) Erratic readings and low reproducibility.
2) Volume dispersion in reaction cuvettes for a same method.
3) Droplets or drop formation on probe tip after each wash cycle.
4) Leaks in the system produced by defective connections or capillary
obstruction by kinks or solids.

To verify, perform the following tests:


1) In the Result printout, the reaction cuvette number is printed. Identify
cuvettes corresponding to a same method and compare volumes in each
cuvette.
2) Repeat one same method at least 5 times and apply statistics. If percentile
variation is greater than 5%, a problem in the hydraulic system is likely to be
present.
3) Enter Test Program. Select Pump Operation, select 4000 steps. Retrieve
liquid ejected by sample probe in a graduated cylinder. The total volume
must exceed 2 ml. Tip should remain with no droplets adhered.

Most common problems encountered in hydraulic system are:


1) Pump tubing wear introducing efficiency loss and eventual leaks. Replace
tubing.
2) Hydraulic system obstruction. Particles present in DI water may clog filter in
pump connector. This usually happens when metal distillers are used.
3) Kinks in probe arm heater tubing or defective connections.
4) Probe clogged by solids from samples or reagent aspiration.

IMPORTANT: Clean peristaltic pump filter and replace pump tubing on a regular
basis.

To clean hydraulic system, proceed as follows:


1) Inspect malfunction by sections, start with pump filter, and then verify pump
operation by disconnecting tube from syringe in diluter and verify dispensed
volume. (Refer toFigure 7 and ¡Error! No se encuentra el origen de la
referencia.)
2) Next disconnect at heater entrance in probe arm and verify dispensed
volume to detect clogging.
3) Disconnect heater in probe arm from sampling capillary and repeat test.
2300GLlTIU Rev. 4.2 96
Rev. 4.2

4) If probe tube is clogged, flush with the aid of a syringe or replace.

NORMALLY OBSTRUCTION WILL DISAPPEAR BY PUMP FLUSH ACTION WHEN


DISCONNECTING AND DISPENSING AT THE MENTIONED POINTS.

If obstruction persists, call Technical Support.

4.7 Photometer and filter cleaning


1) Verify that the instrument is turned off and unplugged.
2) Remove right lateral cover as shown in Figure 8.
3) Provide adequate external illumination for the following operations.
4) Localize photometer and filter wheel.
5) Use cotton swabs to remove dirt from filters surface. Rub gently until
opalescence is removed.
6) NOTICE: Filter No. 0 is an opaque dummy, and requires no cleaning.
7) After cleaning is complete, replace cover, turn the instrument on and allow it
to warm up for 15 minutes.
8) Perform a Calibration. Normally, energy increases by 15% after cleaning.

4.8 Detector lens cleaning


For photometer detail and light beam calibration, see Figure 11.
Detector is accessed within the reaction chamber. Reaction tray must be removed
for cleaning process.

1) Unplug instrument from Mains.


2) Remove 4 cross recessed screws from tray. Remove tray with caution, it is
fragile and should be handled with care.
3) With a lint-free moistened cloth clean reaction chamber if spillages are
visible.
4) Clean discharge funnel with Sodium Hypochlorite Solution 1 and soak with
DI water.
5) Clean detector lens in slit with a cotton swab.
6) Replace reaction tray and screws.

4.9 Information recovery.


One of the most important servicing tools included in Autoanalyzer Metrolab
2300GL is the storage and recovery of information of instrument program, data and
parameters.
There are two forms of getting backups:
1. In Miscellaneous, Backup, user can select to backup Historic file and Methods,
calibrations and parameters, separately. These file are stored, as a first option in a
floppy disk. But if a floppy disk is not present, user is prompted to store in any other
place in the computer. In the same way, data are restored.
2. When exiting the program, user can choose to let system do automatic backup
or cancel the operation. It is strongly recommended to let instrument do a backup
at least once a day.

2300GLlTIU Rev. 4.2 97


Rev. 4.2

This backup is stored in a file whose name is Bu_X.zip where X represent one day
of the week: 1 is Monday, 2 is Tuesday, etc. This way, if previous day backup fails,
there are still other usable backups available.
When recover is activated, you will see:

You can recover from any available date by pressing the Recover button or from
files by pressing Historic or Other Tables. Recovering can be performed from
different floppy disks.
4.10 Calibration
There are several calibrations available in the system. Some of them, photometer
is automatically performed when required. Reference, Cuvette bottom are optional
and some recommendations are included below.

4.10.1 Photometer
Photometer calibration is a normal procedure that can be repeated as many times
as desired. System performs it automatically every 15 days.
It consists in finding the right amplifier gain for all filters in both channels.
The procedure adjusts gains to get maximum number of counts per second for a
given integration time, voltage to frequency converter and filter. Gains range from 0
to 31. Procedure can be followed in the Calibration Table and final values observed
in the Table of Filters.
2300GLlTIU Rev. 4.2 98
Rev. 4.2

1. Num: First column indicates the number of filters (wavelengths in


nanometers):
1 = 340 ; 2 = 380; 3 = 405; 4 = 450; 5 = 505: 6 = 550; 7 = 600;
8 = 650; 9 = 700.
2. GainSple: Sample channel gain. From 0 to 31. It is advisable not to have a
gain of 0 or 31.
3. GainRef: Reference Channel gain. From 0 to 31. It is advisable not to have
a gain of 0 or 31.
4. ZeroSample: Number of counts in absence of light for sample channel.
(Reading of opaque filter number zero)
5. ZeroRef: Number of counts in absence of light for reference channel.
(Reading of opaque filter number zero)
6. FreqSmple: Optimum reading for Sample channel.
7. FreqRef: Optimum reading for reference channel.
8. Ratio: Frequency ratio between channels. Value close to 1 indicates that
system optics is clean.
9. Status: After calibration, indicates that values are within range.
10. Ref. Max and Min.: When system operates in normal measuring mode,
reference channel monitors energy. The table shows minimum and
maximum readings for each filter after the last calibration. If values differ
more then 10% from calibrated reference value, a warning will be displayed
in the message window.

Table also shows the integration time and the limit of converter. Values should be
read as follows: the limit of converter reads for 1 second. Multiply the limit for the
integration time and you will get the maximum allowed reading. Gain is adjusted in

2300GLlTIU Rev. 4.2 99


Rev. 4.2

such way that a value is obtained as close as possible to the limit, without
surpassing it.
Example: if the converter limit is 440000 counts/sec and the integration time is 0.25
sec., the frequencies should be not greater than 110000. If value is surpassed,
gain is diminished in one unit.

IMPORTANT: When a calibration is performed, old calibration data will be placed


in the error log file. Comparison of old and new data will give good idea on the
instrument’s stability.

4.10.2 Reference
Optionally, a water reference can be established and all absorbances will be
referred to a cuvette filled with wash solution. This way, reagent integrity check will
inform “true” absorbances and water and cuvette absorptions will be subtracted.
When this option is selected, wash solution will be delivered in the next available
cuvette and absorbances relative to air, recorded for each filter.
If reference is not determined, all values in the table will be equal to zero and
absorbances relative to air and to the gains in channels. This will not affect
measurements and results.

IMPORTANT: Prepare the wash solution as indicated in Section 3.3, otherwise


bubbles in water can produce erroneous blank data.

NOTE: Reference absorbance data are meaningless: they depend on the relative
gains in sample and reference channels, but absorbances, once reference values
are subtracted, are true absorbances with reference to water. Values are
normalized to 1 cm.

4.10.3 Cuvette bottom


This operation determines where reaction cuvette bottom is located and
corresponding Technical Parameter, automatically updated. In this operation,
system loads in a cuvette a fixed amount of water and next, level position is
evaluated. No message is generated

4.11 Maintenance form

2300GLlTIU Rev. 4.2 100


Rev. 4.2

2300GLlTIU Rev. 4.2 101


Rev. 4.2

2300GLlTIU Rev. 4.2 102


Rev. 4.2

5 TROUBLESHOOTING
Problems can be classified into 3 major groups:

1. Operation malfunctions with visual, acoustic or printed warnings.

2. Visible faults or problems.

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

Definitions:
DM: Daily maintenance procedures.
WM: Weekly maintenance procedures.
QM: Quarterly maintenance procedures.
VT: Validation test. (See chapter 6)

5.1 Operation malfunction with warning


Sometimes, an error is displayed in more than one way. Printed errors correspond
to anomalous conditions found in samples and/or reagents and in no case stop the
run. They are only displayed in the error File. To access it, use Microsoft WordPad:

WordPad error file

Errors are stored in file errors.log. It is stored in folder

\Program Files\Autoanalyzer

Older errors are kept in errors2.log and errors3.log files. They are text files that
can be read with Notepad or WordPad programs. The error file keeps the last 10
operations before the error occurred. It also contains all start-up and instrument
shutdown information.

2300GLlTIU Rev. 4.2 103


Rev. 4.2

Errors shown in the display can be automatically overridden without halting the run.
In Technical Parameters, the “Command Repeat” indicates the number of times an
order is repeated before system is halted. The default value is 3.
In some occasions, errors may be so serious as to force the operator to abort the
run and take corrective actions.

When the error does not affect the Reaction Tray and the photometric reading, only
dilutions will be stopped. A message “Stop Dispensing.” will be displayed. By
pressing the Resume button, dilutions will continue.

If an error persists, even if corrective action solves the problem, Technical Support
Department must be contacted.
When a warning window opens:

Click to continue Click to stop


sound
warning

5.2 Visible faults


1. Drop formation on probe tip after dispensing.
2. Drop formation on probe tip after wash cycle.
3. Abnormal noises.

5.2.1 Drop formation on probe tip after dispensing.


Symptom Corrective Action
Drops on probe tip Verify hydraulic system in accordance to
user’s manual.
Clean probe tip by submerging in
Solution 1 for 5 minutes.
Review “Air Volume” in Technical
Parameters. Increase air volume only if
preceding actions have been taken and
problem persists.

2300GLlTIU Rev. 4.2 104


Rev. 4.2

5.2.2 Drop formation after wash cycle.


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

5.2.3 Abnormal noises.


Symptom Corrective Action
Abnormal noises. Defective fans.
Moving parts blocked or frozen. Contact
Technical Support.

5.2.4 Inaccurate Temperature readings.


Symptom Corrective Action
In “coordinates” temperature in reaction Room temperature too high, (should
tray is too high. (Do not be concerned always be at least 4°C lower than
about arm probe temperature) selected working temperature).
Example: For 37°C incubation
temperature, Room temperature should
not exceed 33°C.
For 30°C incubation temperature,
ambient must be lower than 26°C.
If Room temperature is within limits, and
problem persists, call Technical Support.
In “coordinates” temperature in reaction Room temperature excessively low.
tray is too low. (Do not be concerned Verify instrument operating range, and
about arm probe temperature) adequate the room temperature.
If room temperature is within specified
range and problem persists, call
Technical Support.

5.3 Inconsistent results


1. All methods.
2. Only Colorimetric methods.
3. Fast Kinetics: all or some.
4. Only 2-point Kinetics.
5. Inconsistent automatic repetition values.
6. Coagulation.

When these problems occur, proceed in the following sequence to solve:

1. Verify Main power supply and ground connections. Measure voltage of


ground connection referred to neutral connector.

2300GLlTIU Rev. 4.2 105


Rev. 4.2

2. Use new reaction cuvettes.


3. Comply with Daily Maintenance Routines.
4. Perform a Validation Test VT to detect a module failure. (See Chapter 6).All
Methods

Symptom: Erratic readings.


Possible Cause Validation Test Corrective Action
Test Failed
Number
Unstable lamp. 6.2.1 and 6.2.4 Replace lamp and perform
CALIBRATION.
Unstable photometer 6.2.4 and 6.2.5 Replace lamp and perform
readings. CALIBRATION.
Call Technical Support.
Low signal to noise ratio. 6.2.4 and 6.2.1 Calibrate.
Replace lamp and calibrate.
Perform quarterly
maintenance.
Call Technical Support.
Hydraulic system obstruction. - Perform daily maintenance.
Inspect hydraulic system
Hydraulic system leaks. - Perform daily maintenance.
Verify hydraulic system.
Sample/reagent tray 6.2.5 and 6.2.6 Perform daily maintenance.
positioning error. Call Technical Support.
Filter wheel position error. 6.2.5 Call Technical Support.
Main power fluctuations. -- Verify. Use an Uninterrupted
Power Supply unit if
necessary.
Poor reaction cuvettes. 6.2.2 Replace with new reaction
cuvettes.

5.3.1 Colorimetric methods (one or more)


Symptom: High dispersion of results.
Possible cause Validation Test Corrective Action
Test Failed
Number
Low energy in filter (#). 6.2.1 Perform CALIBRATION.
If condition persists, change
lamp and calibrate.
Perform QM.
Insufficient or defective 6.2.1 Centrifuge sample for a
sample centrifugation. longer period of time and with
a greater number of
revolutions than for manual
methods.
Symptom: Normal values, having low dispersion, are too high or too low.

2300GLlTIU Rev. 4.2 106


Rev. 4.2

Possible Cause Validation Test Corrective Action


Test Failed
Number
Defective standard. - Compare calculated factor
with previous factors stored in
the file. Perform calibration for
that method. If problem
persists, replace standard.
Contaminated standard. - Same as above.
Standard cross- - Change programmed order
contaminated. for standards.
Change job mode (batch
mode to profile mode or vice
versa).
Method’s linear range Differences between Call Technical Support.
exceeded. readings and
automatic
repetitions
Excessive sample volume. - Call Technical Support.
Stray light. 6.2.7 Call Technical Support.
Electronic linearity. ¡Error! No se Call Technical Support.
encuentra el
origen de la
referencia. and
¡Error! No se
encuentra el
origen de la
referencia.

5.3.2 Symptom: Low linear range.


Possible Cause Validation Test Corrective Action
Test Failed
Number
Excessive sample volume. - Call Technical Support.
Poor reagent condition. - Change reagent. Repeat
readings and compare.

5.3.3 Fast kinetics


All Fast kinetics.
Symptom: Erratic readings (High dispersion or low linearity).
Possible Cause Validation Tests Corrective Action
Test Failed
Number
Incubation time too short. - Call Technical Support.
Initial absorbance too high in - Verify reagent preparation.
decreasing kinetics. Replace if necessary.

2300GLlTIU Rev. 4.2 107


Rev. 4.2

Low energy in filter used. 6.2.1 Perform a Calibration. If


problem persists, replace
lamp and calibrate.
Too high electronic noise. 6.2.4 Call Technical Support.
Low precision reaction tray 6.2.2 and 6.2.5 Perform QM.
positioning. Call Technical Support.
Erroneous positioning of 6.2.2 and 6.2.5 Perform QM.
reaction tray. Call Technical Support.
Bad reaction cuvettes. 6.2.2 Use new reaction cuvettes.
Reagent in bad condition. - Replace reagent. Compare
results, if possible program
simultaneously.
Defective lamp. 6.2.4 and6.2.5 Replace lamp and calibrate.
Lamp close to burnout. 6.2.4 and6.2.5 Replace lamp and calibrate.

Symptom: Normal values too high.


Possible cause Validation Test Corrective Action
Test Failed
Number
Electronic noise. 6.2.4 Call Technical Support.
Low available energy. 6.2.1 Calibrate. If problem persists,
replace lamp and calibrate.
Call Technical Support.
Lamp close to burnout. 6.2.4 and6.2.5 Replace lamp and calibrate.

Symptom: Normal and pathological values too high.


Possible cause Validation Test Corrective Action
Test Failed
Number
Incubation temperature too 6.2.10 Call Technical Support.
high.
Incorrect incubation - Verify temperature setting
temperature setting. and application.
Error in factor. - Verify if factor is correct for
selected temperature setting.

Symptom: Normal and pathological values too low.


Possible Cause Validation Test Corrective Action
Test Failed
Number
Incubation temperature too 6.2.10 Call Technical Support.
low.
Incorrect incubation - Verify if factor is correct for
temperature setting. selected temperature setting.
Error in Factor. - Verify if factor is correct for
selected temperature setting.

2300GLlTIU Rev. 4.2 108


Rev. 4.2

Some Fast Kinetics


Symptom: Erratic values.
Possible Cause Validation Test Corrective Action
Test Failed
Number
Low energy with filter used. 6.2.1 Calibrate. If problem persists,
change lamp and calibrate.
Call Technical Support.
Incorrect wavelength setting. -- Review application.
Sample volume too low. -- Use adequate sample
volume.
Defective centrifugation. -- Use longer times and higher
speed than for manual
methods.
Too high initial absorbance -- Replace reagent. Compare
for decreasing kinetics. results.
Too low initial absorbance for -- Replace reagent. Compare
increasing kinetics. results.

Symptom: Normal values too high.


Possible Cause Validation Test Corrective Action
Test Failed
Number
Low signal to noise ratio for -- Calibrate. If problem persists,
the selected filter. replace lamp and calibrate.
Call Technical Support.
Factor error for selected -- Call Technical Support.
temperature and volumes.

Symptom: High or low values for all the range.


Possible Cause Validation Test Corrective Action
Test Failed
Number
Factor error for selected - Call Technical Support.
temperature and volumes.

5.3.4 2-point kinetics


Symptom: Erratic readings.
Possible Cause Validation Test Corrective Action

2300GLlTIU Rev. 4.2 109


Rev. 4.2

Test fail Nr.


Absorbance of standard too -- Review application. Call
low. Technical Support.
Too high initial consumption -- Verify with M2300GLvided by
rate. reagent manufacturer.
Replace reagent.
Poor reagent condition. Replace reagent and
compare results.
Low signal to noise ratio for Calibrate. If problem persists,
selected filter. replace lamp and recalibrate.
Call Technical Support.
Low sample volume. Review application. Call
Technical Support.
Elapsed time too short. Review application. Call
Technical Support.

Symptom: All normal and pathological values high or low.


Possible Cause Validation Test Corrective Action
Test Failed
Number
Factor or standard error. - Verify controls and method
used.

5.3.5 Inconsistent values in automatic repetition or dilution


Symptom: Colorimetric and kinetic reactions are not linear.
Possible Cause Validation Test Corrective Action
Test fail Nr.
Sample volume too high. - Review application.
Verify reagent’s linear limit.
Reagent in bad condition. - Replace reagent and
compare.

Symptom: Non-linear 2-point method.


Possible Cause Validation Test Corrective Action
Test Failed
Number
Cannot be repeated because - Call Technical Support.
volume/absorbance ratio is
not linear.

5.3.6 Coagulation
Symptom: Erratic times.
Possible Cause Validation Test Corrective Action
Test Failed
Number

2300GLlTIU Rev. 4.2 110


Rev. 4.2

Poor reagent condition. - Replace reagent.


Reagent insufficiently mixed. - Mix reagents gently before
use. If many tests are
programmed, mix reagent
every 15 minutes.

Symptom: Coagulation times too short in normal samples.


Possible Cause Validation Test Corrective Action
Test Failed
Number
Incorrect wavelength setting. - Call Technical Support.
Error in absorbance threshold - Call Technical Support.
setting.

Symptom: Coagulation time excessive, or lack of coagulation.


Possible Cause Validation Test Corrective Action
Test Failed
Number
Threshold too high. - Call Technical Support.
Poor reagent condition. - Replace reagent.

5.4 Messages and Warnings

5.4.1 Messages while not operating instrument


Self-explanatory messages are not included in the present listing.
Message Cause Action
Incorrect Serial Number Introduce correct
Serial Number
Analysis to be performed. Attempt to edit a method Do not modify
in use. method still in use.
Change reaction cuvettes. All 80 cuvettes are used. Replace reaction
cuvettes.
Reaction tray not empty. Warning on the existence No action to be
Continue? of used cuvettes. System taken.
will use only clean
cuvettes.
Temperature is out of range. Not enough equilibration Abort startup and
Continue? time wait 5 minutes.
Replace syringe. Continue? Preset limit is surpassed. Replace at the
earliest opportunity.
Follow procedure
outlined in Section
4.3

2300GLlTIU Rev. 4.2 111


Rev. 4.2

Message Cause Action


Replace pump tubing. Preset limit is surpassed. Replace at the
Continue? earliest opportunity.
Follow procedure
outlined in Section
4.3
Replace wash pump. Preset limit is surpassed. Replace at the
Continue? earliest opportunity.
Place solutions in pos. 47 and When testing is finished, Perform wash.
48. place solutions 1 and 2 in
positions 47 and 48.
Clear reaction cuvettes? When Clear button is Confirms cuvette
pressed. blanking.
Error: Sample already used. Attempt to load a sample Load any sample
already in sample tray. only once.
Error: Cannot put second No room in tray for Remove reagents
reagent. second reagent. not in use.
Error: Reagent already used. Attempt to load a reagent Load any reagent
already in tray. only once.
Error: system in automatic Attempt to blank or wash Blank samples with
mode. cuvettes while sample system stopped.
reading is still in
progress.
Field ‘XXXX’ must have a Some data is missing. Check for missing
value. values.
(*)
End of sample processing. Automatic mode is None.
ended.
Key violation. Invalid or repeated value. Check data and
correct.

Invalid variant conversion type. Attempt to convert a null Calibrate


character into a number. instrument.
When present dilution ends, Dilution has been When probe is in
load samples in tray and press stopped. standby place
Resume. samples in tray and
press Resume.
Nothing to be transferred. No data ready to be None.
stored in historic file.
There is no wash solution in One or both wash Replace required
position 47 or 48. solutions are missing. wash solution.
Reaction still in progress. Attempt to edit a method None.
still in use.
Repeated test ID. Only one test ID can be
stored with a given
name.

2300GLlTIU Rev. 4.2 112


Rev. 4.2

Message Cause Action


XX transferred samples Data transferred to None.
YY transferred analysis. historic file.

2300GLlTIU Rev. 4.2 113


Rev. 4.2

5.4.2 Run-time errors and messages


Code Error Action Generator bit Origin Possible solution
and frequency
level
1Probe wet. Dry it. Stop ST1-7 (E11) With resistive sensor, drop Dry electrodes. With capacitive probe,
between electrodes. With warm it to dry. Verify for leaks in upper
capacitive sensor, wet inner connector. If leak persists, replace probe
core
2 Dirty probe. Clean tip Stop ST1-7 (E11)
9 Error in diluter. Repeat ST1-0 (E22) Errors 52, 53 ó 54
and
Abort
10 Error in level sensor
11Waste flooded Stop ST1-7 In old models verify that waste funnel is
not flooded
12Probe impact. Check Tip and Stop ST1-1, ST1-4, Stopcock in reagent or sample. Check and uncap reagents and samples.
ST1-5 (E11) Stacked movement Check for mechanical obstructions. Verify
arm led function
14 Error in Sample Tray Repeat ST1-3 (E11) Dirty sensor. Check sensor. Clean, if necessary. Check
and Sensor touches lid. belt tension. Check for mechanical
Abort Defective sensor. malfunctioning. Check power supply. With
Power supply motors off, check if motion is smooth.
15 Error in Reaction Tray Repeat ST1-2 (E11) Dirty sensor. Check sensor. Clean, if necessary. Check
and Sensor touches lid. belt tension. Check for mechanical
Abort Defective sensor. malfunctioning. Check power supply. With
Power supply motors off, check if motion is smooth.
16 Error in pump Message ST1-6 (E11)
17 Error in Horizontal Repeat ST1-4 (E11) Sensor position1, dirty or Check sensors. Clean, if necessary.
and defective. Mechanical Check for mechanical malfunctioning.
Abort problem in arm Check power supply. With motors off,
check if motion is smooth.

2300GLlTIU Rev. 4.2 114


Rev. 4.2

18Error in Vertical Repeat ST1-5 (E11) Upper or lower sensor Check sensors. Clean, if necessary.
and defective. Mechanical problem. Check belt and gears. Check for
Abort When level must be detected: mechanical malfunctioning. Check power
a) Stop at lower sensor: supply. With motors off, check if motion is
Reagent or sample missing. smooth.
b) Different number of steps:
vertical movement problem
20 Cover open sensor error Message ST0-3 Sensor dirty, blocked or
deteriorated
21Module busy Repeat ST0-2 Overloaded computer Eliminate unnecessary programs. Leave at
least 50 MB free memory. Remove all
screen savers and power savers
22Module inoperative Abort Overloaded computer Eliminate unnecessary programs. Leave at
least 50 MB free memory. Remove all
screen savers and power savers
23Time Out Abort No answer from Instrument off. Instrument is not Check connections, parameters and serial
Autoanalyzer connected to PC. ports
Error in communication
parameters. Defective Serial
Port, either in computer or
instrument.
30CTS Time Out Abort CTS line not Instrument off. Instrument is not Check connections, parameters and serial
enabled by connected to PC. ports
Autoanalyzer Error in communication
parameters. Defective Serial
Port, either in computer or
instrument.
31Error in temperature SPI Message Temperature External noise halted SPI Turn instrument off and re-start operation
controller temperature control
32Warning: Low free disk Message Less than free
capacity 50 Mb in disk
34Sample channel low on filter Message In calibration, Defective Filter Check filter.
gain 31 and less Check lamp voltage.
than 25000 Check filter wheel malfunctioning
counts, sample
channel

2300GLlTIU Rev. 4.2 115


Rev. 4.2

35 Sample channel saturated on Message In calibration, Defective Filter Check filter.


filter gain 31 and less Check lamp voltage.
than 25000 Check filter wheel malfunctioning
counts,
reference
channel
36 Reference channel low on Message In calibration, Defective Filter Check filter.
filter gain 0 and more Check lamp voltage.
than 80000 Check filter wheel malfunctioning
counts, sample
channel
37Reference channel saturated Message In calibration, Defective Filter Check filter.
on filter gain 0 and more Check lamp voltage.
than 80000 Check filter wheel malfunctioning
counts,
reference
channel
38Error in 0%T. When run ends, Message Read frequency Zero setting or calibration, Calibrate. If persists, check noise stability
recalibrate. 50 counts less changed and power supplies
than zero
39Error in Photometer Repeat Errors 60 or 61
and
Abort
40Error in filters or photometer Repeat
and
Abort
41Excessive energy in filter Reference Lamp intensity changed.
channel, more Usually this is a symptom that
than 110% of lamp is close to burning-out
reference
frequency
42Burn Out Lamp or defective Abort Reference Burned out lamp. Change lamp. Verify if failure occurs
photometer frequency less Light is not reaching sensors. always at a given filter
than 2 times zero Defective photometer
level for a given
filter

2300GLlTIU Rev. 4.2 116


Rev. 4.2

44Low energy in filter X Message Reference Normal lamp intensity variation None. Calibrate at the end of the run
frequency 50% along its life
to 90% of
calibration value
45Insufficient energy in filter X Repeat Reference Unusual lamp intensity Calibrate. Change lamp. Check
and frequency variation photometer aligning
Abort between 2 times
noise level and
50% of
calibration value
46Error in calibration Message

47Internal error 1 in dilution Abort


48Internal error 2 in dilution Abort
49Internal error 3 in dilution Abort
50Internal Error Abort Inconsistent parameter values. No. 5. Parameter Pasos_CommMA
(service manual, 3.11) doesn't coincide
with twice Air gap volume in Internal Use
Parameters. Default: 10 and 5,
respectively
No. 7 Parameter “Optimize reading” in
“Internal Use” must be modified.
51Error, table
52Syringe jammed Repeat ST1-3 (E22) Stops before completing the Check screw, lubricate, if necessary.
and required volume Check motor and belt.
Abort
53No Answer Repeat ST1-2 (E22) No answer from syringe Inspect Klohen module connections.
and module Replace, if necessary
Abort
54Wrong parameters Repeat ST0-6 Attempt to go beyond syringe
and limit. (Manual operations)
Abort
57Wrong CRC Repeat ST0-7 Defective communication. Check connectors, serial ports, cables
and Reception not equal to
Abort transmission.

2300GLlTIU Rev. 4.2 117


Rev. 4.2

58Wrong CRC Memory Abort ST0-4 Defective parameters in the With auxiliary board, modify any
instrument boards (COMU and parameter. This resets all CRC's. Next,
CARRU) return to the original parameter.
59 Inexistent command Abort ST0-5 Wrong model selection
60 Error Converter Repeat ST1-3
and
Abort
61Error Filter wheel Repeat ST1-2
and
Abort
62Internal Parameters Repeat ST1-1
and
Abort

Message: Only in Operating conditions and Messages windows


Stop: Big message in screen waiting for operator's action
Abort: operation permanently stops after a number of retrays

2300GLlTIU Rev. 4.2 118


Rev. 4.2

2300GLlTIU Rev. 4.2 119


Ver 4.2

6 VALIDATION PROGRAM AND TESTS

The TEST program is used to check Autoanalyzer M2300GL operating


parameters. When performed by authorized personnel, it will be an official
validation of instrument’s specifications.
The access to it is through Miscellaneous > Test.
There are two sets of tests, labeled Service and Group B. User must use the
Service Set, only. They are selected by pressing Options button. Group B are
reserved for Factory adjustments.
This validation test should be performed after installation, after servicing, by client
request, or periodically, approximately every 6 months.

6.1 Required elements.

Solution a: Potassium chromate, Reagent grade, diluted in water to 5 gr/l, in water


Solution b: Potassium chromate, Reagent grade, diluted in water to 2 gr/l, in water
Solution c: Potassium chromate, Reagent grade, diluted in water to 0,150 gr/l, in
water
Solution d: Sodium Nitrite, Reagent grade, 50 gr/l in water
Solution e: This solution is the wash solution described in 3.3, with tensioactive
Triton X-100 or similar, in a concentration of 20 ppm v/v. For best results, utilize 2
ml per liter of Solution 3, Cat. No. VA0003SL

Solutions a, b and d are included in Calibration Set

2300GLlTIU Rev. 4.2 120


Rev. 4.2

6.2 Description of tests

6.2.1 Energy
Description:
This test performs a calibration of photometer zeros and gains and verifies if
all of them are within range. Previous and present calibration is published.
Materials:
Sample: none
Reagent: none
Parameters:
Compliance:
Errors: 0

6.2.2 Cuvettes
Description:
This test measures all 80 new empty cuvettes in reaction tray and
establishes the minimum and maximum absorbance value, with a tolerance
for the allowed maximum difference.
Materials:
Sample: none
Reagent: none
Reaction tray: 80 new cuvettes
Parameters:
Empty: 0
Normal: 0.300
Tolerance: 0.040
Compliance:
Difference:
Target Min.: 0
Target Max: 0.040

6.2.3 Cuvette dryer


Not operative.

6.2.4 Noise
Description:
This test measures noise of 0%T, static noise at high absorbance and noise
when measurements are made and the reaction tray is randomly moved.
Do not use absorbances above 1,600. Dilution is performed by the
instrument.
Materials:
Sample: Solution b
Reagent: Solution e
Reaction tray: clean cuvettes
Parameters:
2300GLlTIU Rev. 4.2 121
Rev. 4.2

Cuvette: any
Filter: 1
Measurements: at least 30
Min.Absorbance: 1.300 Absorbance units
Compliance:
0%T_SD: 5 counts
Dynamic_SD: 0,003 Absorbance Unit
Static_SD: 0.002 Absorbance units.

6.2.5 Photometer Stability


Description:
This test measures photometer stability for any filter and any number of
readings. To have a confidence interval of 95%, a minimum of 30 readings
must be made. The test has two parts: first part filter wheel is rotated but
measurements are all consecutive, without interval. In this part two
consecutive readings are made each time. Second reading is labeled with
bis identifier. Differences between readings and accumulated difference are
recorded. This allows to determine photometer stabilization time. Second
part, filter wheel is kept fixed and readings are spaced the programmed time
interval. This will determine long term stability.
Dilution is automatically performed.
Materials:
Sample: Solution b
Reagent: Solution e
Reaction tray: clean cuvettes
Parameters:
Filter: 1
Measurements: at least 30
Min.Absorbance: 1.300 Absorbance units
Time interval: at least 30 seconds between readings.
Compliance:
Filter_Move_Diference : 0 to 0.005 AU
Filter_Move_Diference_2: 0 to 0.005 AU
Filter_Move_Mean_Dif : +/- 0.003 AU
Long_Term_Dif: +/- 0.01 AU
Long_Term_Dif_2: +/- 0.01 AU
Long_Term_Mean_Dif: +/- 0.003 AU

6.2.6 Dilution
Description:
This test allows determination of precision in dilution by repeating dilutions
and readings from the same reagent and sample vial. Standard test is with
Concentrated Potassium chromate, 5 g/l as sample and water with 0,02% of
Triton x-100 added.
Complete test with a commonly used end point method: Glucose,
Cholesterol, etc. and any fresh serum sample.
Parameters:
2300GLlTIU Rev. 4.2 122
Rev. 4.2

Incubation Time: 1 minute


Lambda_1: (Wavelength) 340 nm
Lambda_2: (Bichromatic reference): 0
Reagent description: K2CrO4 (Potassium Chromate, 5 g/l)
Reagent position: Any
Sample Position: Any
Reagent volume: 400 µl
Sample Volume: 4 µl
Replicates: 10 (minimum)
Materials:
Sample: Solution a: Concentrated Potassium chromate, 5 g/l as
Reagent: Solution e: water with 0,02% of Triton x-100 added.
Reaction tray: Clean cuvettes
Compliance:
SD: 0.02
CV: 2,5%

6.2.7 Stray light


Description:
This test determines percent of light measured at 340 nm, which does not
correspond to radiation of 340 nm. It is measured by comparing readings of
delivered Sodium Chromate 5 g/l (Solution a) with Sodium Nitrite (Solution
d) at 340 nm.
Samples are automatically delivered.
Materials:
Sample: Solution a, Solution d
Reagent: Solution e
Reaction tray: empty cuvettes.
Parameters:
Positions for solutions a and d
Position for Reagent e
Wavelength: 340 nm
Compliance:
Chromate Solution a: 0,1 %
Sodium Nitrite blocking: 0,3%

6.2.8 Simultaneous
Description:
This test makes readings with simultaneous movements and compares with
single reading.
Materials:
As in 6.2.4
Compliance:
Within 10 mA units.

6.2.9 ISE dilution


Not operative
2300GLlTIU Rev. 4.2 123
Rev. 4.2

6.2.10 Movements
Description:
This is a general procedure to test the operation of mechanical and electrical
parts. Put sample at any position and reagent at any position. Reagent is
taken, sample level measured but sample is not aspirated, reagent is
returned to its reservoir and temperature measured. Error log will
accumulate any detected error. No error should be visible in at least 100
cycles and an ideal condition of 3000 cycles.
Materials:
Sample: water
Reagent: water
Parameters
Measurements: at least 100, get as many as possible
Reagent: any position between 1 and 24.
Sample: any position from 1 to 48
Steps tolerance (steps in level detection): 10
Temperature tolerance: 0.5 oC.

Compliance:
Level_errors: must be 0
Status_errors: must be 0
Temp_Errors: must be 0

6.2.11 Washer
Not operative

6.3 Automated Validation Testing


By pressing button of Batch, all tests will be performed in sequence.
To do that, solutions must be located at the following recommended positions:

Minimum required
Position 1: Solution b 250 µl
Position 2: Solution a 400 µl
Position 3: Solution d 300 µl
Position 23: Distilled water 1 ml
Reagent Position 1: Solution e 35 ml

(See section 6.1)

Operation:
1. Put 80 NEW cuvettes in reaction tray
2. Put solutions b, a, d and e in the specified positions
3. At the end, get the generated report.

Methods included in the batch can be enabled/disabled by selecting Options >


Batch options
2300GLlTIU Rev. 4.2 124
Rev. 4.2

2300GLlTIU Rev. 4.2 125


Rev. 4.2

7 ILLUSTRATIONS

2300GLlTIU Rev. 4.2 126


Rev. 4.2

2300GLlTIU Rev. 4.2 127


Rev. 4.2

Figure 1. Crating unpacking sequence.

2300GLlTIU Rev. 4.2 128


Rev. 4.2

PRO B E A RM

PRO B E A RM
P R O TE C T IO N
(R O T A R Y )

R E A C T IO N C H A M B E R
C O V ER

PRO B E

W A S H S T A T IO N

S A M PL E A N D
M A IN S S W IT C H R EA G E N T T R A Y

R EM O V A B L E C O V ER .
A C C E S S TO D IL U T ER A N D
P E R IS TA L T IC P U M P 2 3 G L V 4 F i- r0

Figure 2. Front view of instrument.


2300GLlTIU Rev. 4.2 129
Rev. 4.2

C O O L IN G F A N S O U T L E T
( K EEP U N O B S TRU C TED )

FU SE H O LD ER

L A M P H O U S IN G M A IN S C O N N E C T IO N
S E R IA L P O R T
C O N N EC T TO PC T O W A S H S O L U T IO N
L EV EL SEN SO R
T O W A IS T B O T T L E (Y E L L O W T U B E )

T O W A IS T B O T T L E W A S H S O L U T IO N
L EV EL SEN SO R IN T A K E
(Y E L L O W T U B E ) 2 3 G L V 4 T i- V 0

Figure 3. Rear view of instrument.

2300GLlTIU Rev. 4.2 130


Rev. 4.2

M ES H FIL TER A N D
C O N N EC TO R

IN TA K E TU B E

D IL U TER C O N N EC TIO N S

TO PRO B E

D IL U TER S Y RIN GE

Z ER O V O L U M E A D J . W H EEL

PU M P B ED S Y STEM
PU M P RO TO R

M A IN S S W ITC H

2 3 G L V 4 D i- v0

Figure 4. Front Panel detail.

2300GLlTIU Rev. 4.2 131


Rev. 4.2

REAGENT HEATER

PROBE LIQUID
CONNECTION

MIXER MOTOR

PROBE ELECTRIC COLLISION


CONNECTION SENSORS

PROBE
M400BC23W

TO REPLACE PROBE DISCONNECT ELECTRICAL AND LIQUID CONNECTIONS.


UNSCREW PROBE BY THE KNURLED COLLAR BELOW MIXER MOTOR.
INSERT NEW PROBE AND REPEAT STEPS IN OPPOSITE ORDER.
REPLACE COVER AND FIXING SCREWS.

M24V4 PROBE CONNECTIONS REV.0

Figure 5. Capillary probe heater connection.


2300GLlTIU Rev. 4.2 132
Rev. 4.2

Nr. Component Part Nr. Order Nr.

A Diluter unit, no syringe VOSB1200 VOSB1200


B 3 way valve VOSB1203 VOSB1203
C Syringe VOSB1202 VOSB1202
D Diluter belt drive (not
shown CO973982 CO973982

1 2
Activate diluter, Unscrew syringe
move plunger and pull gently
downwards. downwards to
disengage.

3 4
Remove plunger Remove syringe.
head fixing screw To replace new syringe
and disengage. proceed in inverse
order.

SYRINGE REPLACEMENT
M24A19, rev.1

Figure 6. Syringe Replacement.


2300GLlTIU Rev. 4.2 133
Rev. 4.2

# This tube connects to the cuvette washing system. See schematics M24A30. Nr. Component Part Nr. Order Nr.

1 Intake tube, PVC Ø6xØ3x1400mm MGPV0306 MGPV0306


2 Peristaltic pump tubing M24M64 M24M64
3 Pump-Diluter tube with fittings M24H17A M24H17A
# 2
4 Diluter-Heater tube with fittings M24H17B M24H17B
5 Diluter syringe, CAVRO725030 VOSB1202 VOSB1202
3 4
6 Probe drain funnel M24H01 M24H01
7 Reaction chamber funnels (Qty:2) M24H19 M24H19
8 1/4"Y barbed connector VACOP06Y VACOP06Y
9 Drain hoses Ø11xØ6x3m MGS10611 MGS10611
10 Drain reservoir with stopper M24H08W M24H08W

11 Wash solution reservoir with stopper M24H07W M24H07W


12 Reservoir mesh filter replacement M24H03 M24H03
PROBE ARM

PUMP

5 6
1
DILUTER

8 7

9
11

12 10 NOTE: Avoid loops in drain hoses


to prevent funnel flooding

Layout of sample handling system.

M24A28, rev.3

Figure 7. Hydraulic input circuit.


2300GLlTIU Rev. 4.2 134
Rev. 4.2

REM O V E SC REW S

REM O V E C O V ER

A C C ES S TO L A M P
L O D G IN G

2 3 G L V 4 L i- v 0

Figure 8. Lateral cover removal for lamp replacement.


2300GLlTIU Rev. 4.2 135
Rev. 4.2

LAMP
ASSEMBLY
Part Nr. VA000LAM

KNURLED NUT
Part Nr. M24F28
Order Nr.
PHOTOMETER

REMOVE KNURLED NUT AND


1 REMOVE LAMP ASSEMBLY

REMOVED LAMP COVER


2 UNPLUG LAMP CONNECTOR

REINSTALL NEW LAMP


3 ASSEMBLY

PLUG-IN LAMP
4 CONNECTOR

5 SCEW LAMP COVER IN PLACE


AND REPLACE SIDE PANEL

23GLV4LAi-v0

Figure 9. Lamp replacement.

2300GLlTIU Rev. 4.2 136


Rev. 4.2

Nr. Component Part # Order Nr.

1 Pump-Diluter tubing w. fittings M24H17A M24H17A


2 Female union M24H14 M24H14
3 Male connector M24H30A M24H30A
4 O-rings OR-201200 OR-201200

5 Peristaltic pump mesh filter M24H30D M24H30D


6 Filter housing M24H30B M24H30B
7 Pump tubing M24M64 M24M64
TO DILUTER 8 Reservoir to pump barbed fitting VAX06365 VAX06365
9 Intake tube MGPV0306 MGPV0306
2

9
8

PUMP TUBING ASSEMBLY.

Figure 10. Pump tubing assembly.


2300GLlTIU Rev. 4.2 137
Rev. 4.2

Figure 11. View of reaction cuvettes when set in light path.

2300GLlTIU Rev. 4.2 138


Rev. 4.2

Figure 12. Sample detector unit.


2300GLlTIU Rev. 4.2 139
Rev. 4.2

2
1 Release tension to bed disengaging spring system.

2 Rotate bed to free tube.

3 Pull fittings up and out of bracket.


Remove old tube from barbed fittings and insert new tube.
Install in inverse order.

PERISTALTIC PUMP TUBE REPLACEMENT

Figure 13. Peristaltic pump tube replacement


2300GLlTIU Rev. 4.2 140
Rev. 4.2

2300GLlTIU Rev. 4.2 141