2300GL User Manual PDF
2300GL User Manual PDF
2300GL User Manual PDF
Metrolab 2300 GL
CLINICAL ANALYZER
OPERATOR´S MANUAL
September 2008
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
WARNINGS
7
Warning: Before using read instructions in Manual
Hazardous Voltage
Ground connection
Biological Risk
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 AD 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
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 AD 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 MAITEACE ....................................................................................................... 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
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.
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.
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.
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.
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
2300GLlTIU Rev. 4.2 14
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.
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.
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
2300GLlTIU Rev. 4.2 16
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
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
2300GLlTIU Rev. 4.2 17
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.
Table of Methods
Table of Samples
Reaction Tray
Manual movements
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.
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).
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.
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
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
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:
Program Files
Autoanalyzer
Data
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.
Edit the Functional Parameters. Modify the default password 12345 to any
desired alphanumeric expression. Also modify the laboratory name, address,
phone, etc.
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)
Perform a “Fill” cycle and several dispensing cycles with diluter speed set to 15.
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:
BDADMIN.EXE
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.
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
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.
Parameters:
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:
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.
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.
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.
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 )
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.
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 = a1 * A
100%
to (%)
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
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 = a1 * A
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.
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
Formula definition
Method assignment
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.
Dilution
ratio 1+N
Generic
diluent Specific
diluent
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.
1) Select
reagent
position
3) Confirm
2) Double click on
desired reagent
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
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.
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.
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.
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.
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.
Select with
double click
Open Table
of Methods
in Use
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
from the Table of Panels. (See below the same procedure for controls and
standards).
Panels When pressing this key, the correct tab selection will open.
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.
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.
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..
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.
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.
Selector is the correlative number and not the Sample ID. This way, there is full
control on the desired samples and ordering.
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
Right button
Left button
Right button
Left button
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.
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.
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.
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
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 )
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
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.
Host ANALYZER
Computer
Instrument
Computer
Lims connection is performed through a standard Serial Port RS232C. Serial port
must be other additional to these used for connection with instrument.
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
and time
Ending 8 (X) Structure YYYYMMDDHHMMSS.
request of
results, Date
and time.
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:
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.
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.
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
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.
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_1 – Abs_0
Cons. = ----------------------- X 60
T1 – T0
Analysis is repeated with a sample volume reduced with the volume factor.
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
Sx * Sy - n * Sxy
A1 = -------------------------
Sx * Sx - n * Sx2
Calculated concentration is
C = Method Factor * A1
Num# = n * Sxy – Sx * Sy
Den1# = n * Sx2 – Sx * Sx
Den2# = n * Sy2 – Sy * Sy
Num#
LRC = ---------------------------
(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*)
2.12.2 Color
Color readings are made by subtracting sample reading from reagent blank
Concentration is calculated as follows:
Co
Method Factor = ------------------------------
( Abs_1 – Blk )
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 )
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
Reading is
aborted. No
No coagulation
and valid result.
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.
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 ).
For best results use Solutions 1 and 2 respectively, included in kit Cat. No.
VA0000SL
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
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:
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.
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.
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.
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
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.
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 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.
Reading is completed
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.
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.
4 MAINTENANCE
*Daily care.
*Weekly care.
*Quarterly care.
*Maintenance as needed.
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:
To solve problems, see Section 4.6: Control and maintenance of hydraulic system.
Replace pump tubing even if cycling time is not reached. See Figure 10
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.
*Remove solids from tip with a cotton swab soaked in Solution 1. Dry with lint-free
tissue.
* Clean drain funnel in wash station. Use Sodium Hypo chlorite Solution 1 and
rinse with water.
* Clean instrument table top with a moistened cloth. Do not use organic solvents or
acids.
*Message indicating pump tubing replacement. Replace tube and confirm with YES
in the corresponding display. Section 4.3
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:
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.
The same procedure is valid for syringe replacement. (See Figure 6).
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.
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.
A cleaning cycle must be performed when indicated. If protein deposits are seen
on the tip, remove gently with a tissue paper.
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.
IMPORTANT: Clean peristaltic pump filter and replace pump tubing on a regular
basis.
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
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
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.
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.
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.
5 TROUBLESHOOTING
Problems can be classified into 3 major groups:
Definitions:
DM: Daily maintenance procedures.
WM: Weekly maintenance procedures.
QM: Quarterly maintenance procedures.
VT: Validation test. (See chapter 6)
\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.
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:
5.3.6 Coagulation
Symptom: Erratic times.
Possible Cause Validation Test Corrective Action
Test Failed
Number
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
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
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
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
6.2.4 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.
6.2.6 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
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.
6.2.10 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
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
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.
7 ILLUSTRATIONS
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
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
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
REAGENT HEATER
PROBE LIQUID
CONNECTION
MIXER MOTOR
PROBE
M400BC23W
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
# This tube connects to the cuvette washing system. See schematics M24A30. Nr. Component Part Nr. Order Nr.
PUMP
5 6
1
DILUTER
8 7
9
11
M24A28, rev.3
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
LAMP
ASSEMBLY
Part Nr. VA000LAM
KNURLED NUT
Part Nr. M24F28
Order Nr.
PHOTOMETER
PLUG-IN LAMP
4 CONNECTOR
23GLV4LAi-v0
9
8
2
1 Release tension to bed disengaging spring system.