I M PORTA N T N OTI CE

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 2

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6 7 9

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④
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⑥

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 2

1 6

4
10
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 TO HOST COMPUTER EXTERNAL
MONITOR
PS2 # MOUSE PORT

TO UPS RS232
CONNECTOR

RX # KEYBOARD PORT

LAMP FAN

BLUE TUBE: WASTE 1 (NEEDLE WASH)

BLACK TUBE: WASTE 2 - READING

CUVETTES (REAGENTS + SAMPLE)
 DILUTER
READINGSTATION

PHOTOMETER

MODULESVIEW
1 – COMPUTERBOX
2 – READINGSTATION
3 – POWERSUPPLY
4 – REAGENTSMODULE
5 – SAMPLESTRAYMODULE
SAMPLES 6 – ISEMODULE
7 – SAMPLINGARM
CHAPTER B
♦
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9
♦
 Always check and empt y
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FLOPPY DISK AND CD-ROM

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 OPERATOR MANUAL
BT 3000 PLUS

SECTION I: GENERAL INFORMATION

CHAPTER D
1. PERFORMANCE AND LIMITS Page: 2

Biotecnica Instruments S.p.A.

Via Licenza, 18
00156 Rome – ITALY
1. PERFORMANCE AND LIMITS

PERFORMANCE
Operating Mode “Random access”
Methods Tests for Clinical Chemistry and Immune-Chemistry
I.S.E. Module Na, K, Cl (CO2 optional)
Test Mode Routine, Batch, Emergencies (STAT), Profiles
Tests on line 80 refrigerated reagents + Relation Tests
Tests in memory 500 single- or double- reagent + unlimited Relation Tests
Test Reruns Automatic or on demand
Calibrations and Controls Automatic or on demand
Automatic Profiles Automatic execution of related profiles or on demand
Measurement Direct reading of 34 cuvettes (made of special optical glass)
Samples Tray Capacity 52 positions for Samples & STATs, 26 for Standards and Controls
Bar code scanner 2 separate scanners for positive identification of samples & reagents
TIME REQUIRED TO REACH STEADY STATE
Ambient conditions (Analyzer): 21°C R.T., 33% RH
Time required for the analyzer to completely reach steady state: 20 minutes
Ambient conditions (Refrigeration Chamber): 21°C R.T., 33% RH
Time required for the refrigerated bottles to completely reach steady state: Approx. 2 hours

CLINICAL CHEMISTRY
Sampling cycle: 11 seconds
Analytical throughput: 330 tests/hour (single reagent)
Test execution time max 360 seconds
ISE PROCEDURE
ISE Test execution time: 70 seconds
Sample throughput: 51 Samples/hour
Analytical throughput: 204 Results/h (K+, Na+, Cl- and CO2)

CUVETTE OPERATING TEMPERATURE

Programmable Temperatures: Room Temperature, 32 °C, and 37 °C
Precision ± 0,2°C - Accuracy ± 0,2°C
Temperature Monitoring Device based on Peltier Effect

REAGENT CHAMBER TEMPERATURE

Nominal Temperature: 11°C Approx.
Temperature Monitoring Device based on Peltier Effect

OPERATING AMBIENT TEMPERATURE

18 °C to 32 °C, 10% to 90% RH, Non condensating
PHOTOMETER
Optical System Solid state photometry, (patented by Biotecnica Instruments S.p.A.)
Detectors 10 silicon photodiodes for UV/Visible +1 reference channel
PRECISION AND ACCURACY
Spectral response: 340, 380, 405, 436, 480, 510, 546 578, 630, 700 nm
Bandwidth: ± 5 nm max
Photometric precision: ± 1% from 0 to 2.000 O.D., ± 2.5% at 2.400 O.D.
Photometric sensitivity: ± 0.0005 ABS
Drift: ± 0.005 ABS/h (steady state)
Light path: 7 mm
Light source (Photometer): Reflectorized Halogen dichroic lamp, 12 VDC, 35 Watts
Life hours: Approximately 2000 hours
NOTE: For optimal result the lamp can be used for about 1,500 hours. The long-term use will
result in the gradual deterioration of the UV emission.

DILUTER - TECHNICAL SPECIFICATIONS

Diluters Type: Biotecnica Diluter Module
Max Volume: 470 µl
Linearity: ± 0.1% (full scale)
Accuracy at 3 µl: ± 3%
Accuracy from 10 to 470 µl: ± 1%
Reproducibility: ± 0.7% at 3 µl ± 0.6% > 3µl
Life Expectancy: 3 million operating cycles
Maintenance: every 300.000 operating cycles (O-ring seal replacement)

VOLUMES
WORKING SOLUTIONS
Clinical Chemistry
Reaction Volume: 280 µl min. to 700 µl max. (double reagent)
Sample Volume: 1 to 100 µl
ISE System
Concentrated Buffer Solution: 50 µl + 400 µl (H2O)
Concentrated Reference Solution: 50 µl + 400 µl (H2O)
Sample Volume: 30 µl
Concentrated Buffer 10 ml: 200 tests
Concentrated Reference Solution 10 ml: 200 tests
RESIDUAL VOLUMES FOR REAGENT BOTTLES

NEW SERIES
80 ml BOTTLES: Approx 1 ml
50 ml BOTTLES: Approx 1 ml
20 ml BOTTLES: Approx 0.5 ml
10 ml BOTTLES: Approx 0.5 ml
ISE MODULE
Number of electrodes: 4 plus Reference Electrode
Analytes: K+, Na+, Cl- and CO2 on command
Test execution time for ISE: 70 seconds
Sample throughput: 51 Samples/hour
Analytical throughput: 204 Results/hour (K+, Na+, Cl- and CO2)
Reagents: Buffer and Reference Solution (concentrated)
Sample Type: Serum, Urine (whole)
Sample Volume: 30 µl
Concentrated Reagents Dilution: 1/10 with H2O (automatically)
Dilution of Serum/ Buffer: 1/14 (automatically)
Precision on Serum test: ± 1% for K+ & Na+ , ± 2% for Cl-, ± 3% for CO2
Precision on Urine test: ± 2% for K+, Na+ and Cl-
Linearity for Serum test: Na=50-200mEq/L K=1-20mEq/L
Cl =50-400mEq/L CO2=10-45mEq/L
Linearity for Urine test: Na=20-400mEq/L K =2-200mEq/L
Cl =40-400mEq/L
Accuracy for Serum test:
Intra Run Serum (N°20 samples): Na+ and K+ C. V. < 1%
Cl- C. V. < 2%
CO2 C. V. < 5%
Infra Run Serum (N°20 samples): Na+ and K+ C. V. < 2%
Cl- C. V. < 2.5%
CO2 C. V. < 5%
Accuracy for Urine test:
Intra Run Urine (20 samples): Na+, K+ and Cl- C. V. < 2%
Infra Run Urine (20 samples): Na+, K+ and Cl- C. V. < 2.5%
Life expectancy for electrodes: Na+ and Reference Electrode 12 months
K+ 3 months
Cl- & CO2 3 months

RUNNING TIMES FOR “ UTILITY”

Wash & Fill Up: 270 seconds (approximately)
Wash H2O: 180 seconds (approximately)
Zeroing: 420 seconds (approximately)
F.C.C.: 900 seconds (approximately)
Extra Wash ISE: 800 seconds (approximately)
Extra wash cuvette: 540 seconds (approximately)
Wash Shut Down: 12 minutes (approximately)
WASHES VOLUMES
Clinical Chemistry Washes
H2O single wash of cuvette: 5 ml (approximately)
H2O Single wash of Needle: 2 ml (approximately)
Consumption per test: 7 ml (approximately)
H2O for zeroing: 250 ml (approximately)
H2O total wash of cuvette: 170 ml (approximately)
Extra wash of cuvettes: approx. 170 ml H2O + 13 ml Cuvettes Washing Solution
ISE Washes
H2O per test: 2 ml (approximately)
ISE extra wash: 0.5 ml ISE Washing Solution
0.5 ml Enzyme Solution
Operating Limits
The instrument cannot guarantee the preceding performance specs in the following conditions:

1) Ambient conditions beyond the specified range.

2) Use of non-conformant clinical chemistry products such as washing solution, distilled water,
ISE reagents and etc.
3) Maintenance schedule and expiry date ignored.
4) Use of non-original spare parts and consumables.

The manufacturer does not guarantee the correct instrument. Incase of implementation of
unanticipated methodologies. Consult your nearest sales/service office or factory for the use of
different methodologies.
CHAPTER E
Single bottle

Whole sector:
New Entry Routine
⇐⇒
New Entry/STAT

New Entry/Controls:
→
♦

♦
NOTE:
The Biotecnica Instruments S.p.A. is responsible for the password application. If necessary one can request
the current software version with different procedures from the ones outlined here. Any eventual request must
be drawn up freeing manufacturer of any responsibility.
Refer to the following pages for detailed description.

NOTE:
The password must have at least 8 characters. The administrator has no access to the instrument but to a
special window for the management of users and the possibility of insertion/removal of users.
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 OPERATOR MANUAL
BT3000 PLUS

SECTION I: GENERAL INFORMATION

CHAPTER L
1. ISE MODULE
1.1. Introduction Page: 2
1.2. Parameters Page: 3
1.3. Programming Standards and Controls Page: 5
1.4. Replacing and Installing Electrodes Page: 8
1.5. Preliminary steps before starting the system Page: 9
1.6. Calibration procedure Page: 10
1.7. Measuring unknown samples Page: 11
1.8. Precautions for ISE Module usage Page: 12
1.9. Suggestions for performance maintenance Page: 13
1.10. Troubleshooting Page: 13

Biotecnica Instruments S.p.A.

Via Licenza, 18
00156 Rome – ITALY
1. ISE MODULE

1.1. INTRODUCTION
In addition to the Clinical Chemistry and Immune-chemistry tests, the BT3000 PLUS
analyzer allows tests for the Na+, K+ and Cl- (CO2 optional) ions with ion selective
electrodes (ISE module).

The device consists of a reading module with a dedicated sampling arm and therefore can
be considered as a stand-alone module of the instrument.

The system is called "Ion Selective" as the electrodes used respond to their respective ions
in accordance with the Nernst equation:

E = E0 + RT/nF log aM+

aM+ = M+ ion activity
E = observed potential in Volts
E0 = constant (standard potential for a redox semi-reaction referred to hydrogen electrode)
R = gases’ constant
F = Faraday’s constant
T = temperature in Kelvin degrees
n = ion’s charge

It is highly recommended to carefully read this chapter before using the system. The user
should also keep in mind that all the ISE components must be maintained in optimal
operating conditions to ensure precise and accurate determination of results.

The correct use by the well-qualified personnel, assures quality test results as well as a
longer duration of the electrodes. Lifetime for electrodes is about 1 year for sodium and
reference, 3 months for potassium, chloride and carbon dioxide.

However, the electrodes lifetime depends upon the number of samples determined, and the
observation of routine maintenance at proper intervals.

For a correct use of the system, the user must observe some basic functions such as initial
restoring for electrodes conditioning, calibrations repeated every 4 hours or at any
temperature variation that is greater than 3°C and at the substitution of working solutions
(Buffer & Reference). When turning off the analyzer it is necessary to perform a washing
procedure with appropriate detergent solutions. This chapter gives some operating
suggestions and GLP to help assure precision and accuracy of the system.

The ISE module (Figure 1) is located inside the right side of the analyzer. The ISE reagents
are positioned near the ISE module and are accessible through an appropriate panel. The
module can be removed by opening the panel and extracting it upwards (all fluidic tubes
must be disconnected before ISE module removal). If the module is removed from, it's
lodging, the ISE arm will be inoperative.
 Funnel (or bowl)

Pinch-valve

K+, Na+, Cl- Electrodes

Reference electrode

By-pass Electrode
(or CO2 optional)

“Ground” Electrode

Figure 1

1.2. PARAMETERS
Modify analytical Modify analytical parameters
parameters (All Tests) (Current Tray)

Go to " Test Parameters, Standards and Controls (Global)" page (Figure 2) or the " Test
Parameters, Standards and Controls (Current Tray)" page (Figure 3). Select " ISE" , and
then click " Parameters" to display the screen showing analytical parameters for the ISE:
" General Parameters" , " Serum’s Parameters" , and " Urine’s Parameters" . The
" General Parameters" is displayed first (Figure 4), to access the other parameters click on
the corresponding tags.

Figure 2
 Figure 3

GENERAL PARAMETERS: In this page it is possible to program the general parameters

for the ISE.
" Sample µl" : Sample volume expressed in µl, default
value is 30 µl.
" Serum dilution 1:" : Sets dilution ratio between
sample and reagent, default value is set at 14.
" Reagent dilution 1" : Sets dilution ratio for
concentrated reagent, default value is 10. Using this
parameter the analyzer prepares (dilutes) the working
reagents such as “Reference (Baseline) Solution” and
“Buffer Solution”, which are CONCENTRATED.
" 1st Unit" : Enter value in the corresponding field and
enable " 2nd Unit" to enter a second value and
Figure 4 instantly a new textbox appears where the user can
enter the second unit and the second unit’s
conversion factor. In case of double units, the test values are expressed with two results. In
analytical calibrations, the first measurement unit is used.
" Number of Washes" : Normally one wash is usually sufficient. To set a different number of
washes (maximum 9) use up/down arrow keys “v ” or enter the value directly into the box.
This option allows the user to set the number of washes that will be run at the end of
dispensing the reagent used for the programmed test.
" Incubation Time" : Incubation time expressed in seconds, default value is 2 seconds.
" Reading Time" : Analysis’ reading time, expressed in seconds, default value is set at
4seconds.
" Decimals" : For setting the number of decimal digits in test results (" Automatic" or
" Custom" ). If a value is not specified, then the analyzer automatically assigns number of
decimal digits using the “Floating point” algorithm.
" Electrodes in use" (K Na Cl CO2)" : Click the check boxes to select the electrodes to be
used among those available here. This command selects or deselects electrode. Press
"Cancel" to exit this page.
 SERUM’S PARAMETERS: Here it is possible to
assign the " Normal range" (Figure 5) for each
electrode and, if needed the panic range for
pathological repetition. The programming of the
normal range values for "Man", "Woman" and
"Child" is assigned specifically to each electrode.
To assign the normal (and panic) range to each
electrode, click corresponding tag.
To visualize the “Panic range”, click " Re-run
pathological" checkbox. If "Re-run pathological"
option is selected, the analyzer will repeat all
Figure 5
pathological results outside the given range.

URINE’S PARAMETERS: In addition to the

same functions as the "Serum’s Parameters", it
also has the " µl Water" field (Figure 6). This is
used for entering the volume in µl of water that
must be used for washing the hydraulic circuit at
the end of a test determination.
Note: The CO2 electrode is automatically
excluded In Urine’s parameters (it does not
appear even if it is present in the electrodes in
use).
Figure 6

1.3. PROGRAMMING STANDARDS AND CONTROLS

INSERTING STANDARDS: Go to " Test Parameters,
Standards And Controls (Global)" page (Figure 2) or
the " Test Parameters, Standards And Controls
(Current Tray)" page (Figure 3). Select " ISE" , and
then click " Standards" to display the " Standard
parameters for ISE" (Figure 7). Standards
programming (automatic or on request) follows the
same procedure of Clinical Chemistry (Chapter C,
paragraph 1.5. " Calibrations" ). For system
calibration, two known standards (Low and High) are
required.
The calibration parameters of the module and the
relevant slopes calculated for each electrode are
displayed together. Here it is possible to set an
Figure 7 automatic standardization timer and assign two
positions for low and high standards (same as clinical
chemistry procedure outlined in Chapter C, paragraph 1.5.).
" Low standard position" and " High standard position" : Write in these fields or select
with up/down arrow keys “v ” the positions for I.S.E. calibrators.
NOTE: The low standard position must precede the high standard position.
" Timed re-run" : It is possible to program automatic execution of calibration using this
parameter. The analyzer will issue a warning message when the programmed
standardization ends. If the reagents and standards are present, then one can directly
perform the calibration. Insert the standardization time by enabling "Time selection" and
program the corresponding field. One can enter interval of hours or days in this field.
" Last Standardization" : The time and date of last test calibration are shown here.
" Slope" : After each calibration,
the calculated values for the
slopes are updated in these fields.
Calculated slope values must be within the indicated ranges.
" Slope Min / Max" : By double-
clicking the textboxes, slope
ranges are individually set for
each electrode. Refer to test methodology for correct values. The slope values are
important for verifying a correct calibration and the electrodes status. When a slope is out of
range, it will probably mean that the electrode must be replaced.
“ Standard Low/High” : Double
clicking the appropriate fields one
can program the concentration
values of the two standards for each electrode. Every time standards are changed, the set
points must be changed as well. Refer to the kit insert or to the standards label for the
correct values.
BSF: This parameter is a Base
Line Factor and is used only for
CO2. It must be set to 10. It is a linearity correction factor.
“ View used positions” : This command shows all the positions used by standards.

INSERTING CONTROLS
Go to " Test Parameters,
Standards And Controls
(Global)" page (Figure 2) or
the " Test Parameters,
Standards And Controls
(Current Tray)" page (Figure
3). Select " ISE" , and then click
" Controls" to display the
" Controls parameters for ISE"
(Figure 7). The Controls
programming (automatic or on
request) follows the identical
procedure of Clinical Chemistry
Figure 8 (Chapter C, paragraph 1.4.
" Controls" ). Selection of a
single electrode is required prior to controls programming. Use the command " Save" for
memorizing data, " Cancel" for leaving the program without saving changes, and " Print" for
hard copy printout.
The displayed page is divided into two parts, one for the " Known" controls
and the other for the " Unknown" controls (Figure 8). The opening page is
default set to " Level(1)" controls. To set parameters for Level 2 and 3, click
corresponding tabs.
KNOWN CONTROLS
" Known" Controls: Select the electrode, prior to entering the control’s
range values.

" Lot Name" : Enter a name or a lot number.

" Sample position" : Enter the sample’s physical position on the plate. The reserved
sample positions are located in the inner circles of the sample plate and are dedicated to
calibrators and controls. The numerical positions on the sample plate correspond to those
established in the " Setup Analyzer" (refer to Chapter H, paragraph 2. " Setup Analyzer" ).
" Low value" : Enter the lower value for the control’s range.
" Theoretical Value" : Enter the theoretical value for the control.
" High value" : Enter the higher value for the control’s range.
" Timed re-run" : This parameter
allows programming of automatic
execution of controls. It is
possible to insert automatic
execution time for each single
control. Check " Timed re-run"
box and then Click " Timed re-
run" (just above the " View used
Figure 9 positions" ) to display " Insert re-
run timing" screen (Figure 9).
Here one can enter interval of hours or days (refer to Chapter C, paragraph 1.4.) for
automatic controls run.
“ upon Date” (daily interval): Select the function and set daily interval, then enter test
running time (for example 1 08,30 means every day at 08,30 or in any case at start up).
“ upon Hour” (hour interval): Select the function and set the desired hour interval, hours
and minutes.
Every day or when the preset time expires, the analyzer will automatically alert the user that there are
controls to be run. If reagents and controls are present, then the user can directly confirm to execute the
tests.
“ View used positions” : This command displays the test disposition.
NOTE:
Enter the same parameters also for Level 2 and 3 controls.
UNKNOWN CONTROLS
The only parameters to be set are the lot name or number, the sample position on the
sample tray and the timed re-run for each level. Reserved positions are located in the inner
circle of the sample plate and are dedicated to the calibrators and controls. The numerical
positions on the sample plate correspond to those already set in the program “ Setup
Analyzer” (refer to Chapter H, paragraph 2. " Setup Analyzer" ).
After programming all the parameters, save parameters by clicking “Save” button. Click
“Print” for hardcopy printout of control parameters.
1.4. REPLACING AND INSTALLING ELECTRODES
The analyzer is supplied with the electrodes already installed in the ISE module.
To replace or install the electrodes the analyzer must be turned off and then the following
steps must be observed:

WARNING
Do not touch with bare hands the small metallic tubes of the electrodes, the contacts
of electrodes, or the sensor electronics, in order to avoid electrostatic discharges
that may cause permanent damage or system malfunction.

Thumbscrew securing
Metallic shield

Pump Cartridge

Dilutor Pinch Valve

Dilutor

Peristaltic Pump

Figure 10

1. Before installing or replacing electrodes, remove the ISE module as shown in Figure 10
and unscrew the thumbscrews securing the metallic shield.
2. Disconnect the tubes 2, 3, 4 and 5 (Figure 11) from the electrodes. Remove the
housing containing measurement electrodes (K, Na, Cl, By-pass or CO2) by gently
moving leftwards (Figure 11). Remove the housing containing Reference and Ground
electrodes by carefully moving it rightwards. Keep these housings in vertical position
when electrodes are present.
3. Carefully remove the electrodes from their respective housings by gently pressing on
the backside. Always maintain the electrodes stack in vertical position.
4. It is recommended to immediately disconnect the first electrode (K) from the next one.
5. Replace the defective electrodes with new ones.
6. Reassemble the electrodes stack and place it into its housing.
7. Position the housing with the measurement electrodes on the ISE panel, and gently
press fit to the right into the appropriate connecting pins of the detection electronics.
8. Carefully fit the housing with Ref & Ground electrodes by gently pushing to the left into
the pins of the detection electronics.
9. Reconnect tubes 2, 3, 4 and 5.
10. Secure the metallic shield using the thumbscrews.
11. Insert ISE module into its appropriate slot.
 Tube 2

Tube 3

Tube 4

Tube 5

Figure 11
1.5. PRELIMINARY STEPS BEFORE STARTING THE SYSTEM

This procedure is necessary when installing the system or after replacing the electrodes.
For normal operating functions, observe the following procedure:
a) Place the working solutions in their respective lodgings (Figure 12).
b) Make sure that the contents of the working solutions are sufficient for the necessary
workload.
Caution
This verification of volumes (for necessary workload) is highly recommended. Whenever baseline or buffer
solutions are changed, a new calibration of the system must be performed, which is not possible during the
determination of tests.
c) Run “ Prime I.S.E.” (refer to Chapter H, paragraph 1.1.1.) and repeat it for at least three
times.

Working Solutions

Figure 12
NOTE:
If one or more electrodes or any other component has been replaced, then it will be
necessary to perform additional calibrations for reconditioning.
d) Verify that programmed values for the standards (high level/low level) correspond to the
used lot. Programming is performed as shown in Figure 7, where the values for two
standards must be entered for the calculation of slope during the calibration.
e) To reduce the risk of contamination of baseline and buffer solutions through ambient air,
it is suggested to remove and close the two bottles at the end of daily working sessions.
Remember to open and replace these bottles at the beginning of every new working
session.
The ISE module should be considered by the user as an ordinary test for Clinical Chemistry
requiring a programming of its own for standards and controls. Calibration should be
performed every four hours and it is essential for precise and accurate results. In addition, it
is recommended to execute repeated calibrations until a stable slope value is obtained.

1.6. CALIBRATION PROCEDURE

Standards are automatically diluted with buffer solution (pH 8.6) with a ratio of 1:14. The
mixed product is aspirated into the electrodes through the peristaltic pump. After an
incubation period, the reading is performed.
At the end of calibration phase, the slope is calculated in accordance with Nernst equation:
Slope (s) = ∆E/(log STD high - log STD low)
where ∆E = difference in mV between STD high and STD low
After calibrating each electrode, optimal slopes are obtained which should be within the
following acceptance range:
K 50 / 60 mV
Na 55 / 65 mV
Cl -35 / -52 mV
CO2 -22 / -32 mV
NOTE:
In addition to the acquired slopes values, it is important to observe also the potential of the standards mV STD Low and
mV STD High in the calibration printout (refer to Chapter G, paragraph 1.). In the optimal conditions, these values can be
reproduced quite easily with slight variations around nominal value. The potential of the standards in association with the
obtained slope values, are useful for evaluation of a correct calibration. When electrodes are not efficient, for example,
when poor or no maintenance has been performed, or in case of contamination or degradation of the working solutions
(Buffer, Baseline, or STD), the potential values vary considerably. This results in erroneous slopes indicating that the
operating conditions are not optimal. However, in some cases, the potentials have incorrect values, but the slopes are
apparently acceptable. Be cautious with this situation as the precision and accuracy of tests results will be affected by an
incorrect calibration.
The potential values are related to standards, thus by changing standard’s lot with another concentration, the different
potentials will be observed with the same slope values. To optimize system performance it is fundamental that both the
slope and potential values are always around established levels.
In case the slope values are out of range, an on-screen error message is displayed, even if there is an incorrect response
from only one electrode. A check is also performed on the slopes reproducibility. The values obtained during current
calibration are compared to the values of previous calibration. An error message appears during calibration if there is a
variation greater than 3% for K and Na, and 5% for Cl and CO2.
Each standard measurement is followed by a baseline measurement. The baseline is a reference solution used for
compensating any eventual drift of the system.
IMPORTANT NOTICE
a) After an incorrect calibration or in case of a calibration beyond the preset limits, the
analyzer automatically performs a new calibration with up to 3 calibrations maximum.
b) Once the calibration standards are poured into the sampling cups, they are stable for no
longer than 15 minutes. If calibrations, for any reason, last longer than this time, it is
necessary to replace standards with fresh ones and repeat the calibration. The bottles
containing buffer and reference solutions must be placed on the analyzer (open bottles -
at room temperature) at least 30 minutes before operating phases begin and to allow for
equilibrium with ambient temperature and with the carbon dioxide (CO2) level in the air. If
the thermal equilibrium is not reached, then the phenomena of drift effects and erroneous
results can occur, while a lack of equilibrium with CO2 may provide higher results for the
latter test.

NOTE:
If slopes and potentials are constantly out-of-range, this indicates that the electrodes are exhausted, or there is an
aspiration error of the reference (baseline) solution in the reference electrode, or the working solutions (buffer, baseline,
STD) are contaminated or degraded. In case of contamination or degradation, replace in sequence the buffer solution,
then the reference solution and at last the standard. Whenever a product is replaced, repeat the calibration procedure. In
the other cases such as exhausted electrodes or a baseline aspiration error in the reference electrode, refer to the
Troubleshooting guide.

1.7. MEASURING UNKNOWN SAMPLES

After a correct calibration, the samples are determined, which are prepared and read in
similar manner to standards: dilution 1:14, aspiration into the electrodes, potential reading,
and the reference (baseline) aspiration. The samples are calculated applying Nernst
equation:
E - E0 = s log (Cx / C Std)
Considering the fact that the system requires a calibration, the measurement method is
defined as “comparative”.
ISE tests are programmed in the same way as any other analysis of clinical chemistry.

Precision and accuracy errors when determining samples

NOTE:
In case of errors during samples determination, please follow indications outlined in the Troubleshooting guide.

Determined results can be associated to a flag that indicates eventual problems occurred
during measurement.
The presence of “D” flag near a result, relevant to one or more electrodes, indicates drift
during sample reading, i.e. the drift has exceeded ±2mV and thus the electrode may be
unstable.
The flag “L” near the results indicates the absence of reference (baseline)
solution.
The flag “B” adjacent to results indicates the presence of air (bubble) in the
hydraulic circuit during the transfer of the sample into the electrodes.
The sign “…… +” in place of the results, indicates abnormal values (for example
9999999,999). This situation may be result from an interruption of the liquid flow into the
electrodes during the test reading phases.
1.8. PRECAUTIONS FOR ISE MODULE USAGE
♦ The ambient conditions play an important role in the correct use of the ISE module.
Room temperature must be between 20°C and 26°C, and the humidity between 35%
and 75%.
♦ If the room temperature varies (even by 2°C or 3°C) during a working day, then it will be
necessary to repeat the calibration of the ISE module just before running tests to avoid
errors during next readings.
♦ It is suggested to insert the bottle containing buffer solution (open bottle - at room
temperature) in the reagent tray at least 30 minutes before operating phases begin and
to allow for equilibrium with ambient temperature and with the carbon dioxide (CO2) level
in the atmosphere. If the thermal equilibrium is not reached, then the phenomenon of
drift and erroneous results may occur, while a lack of equilibrium with CO2 may provide
higher result values for the latter test.
NOTE:
ISE Module should be calibrated only after the above-mentioned equilibrium has been reached.
♦ When using the chemical standards, bear in mind that they are altered by air exposition.
Therefore, it is recommended to fill the cups ¾ full (to minimize evaporation effect) and
run the calibration immediately afterwards and then discard the remaining standard. In
any case, do not leave standards exposed to air for longer than 15 minutes.
♦ It is suggested to run “ Prime I.S.E.” before running tests and repeat this procedure at
least three times.
♦ It is recommended to run the standardization twice a day, in the morning and in the
afternoon or in any case every four hours. To ensure a successful calibration, repeat it
up to three times and verify if the results are stable. Standards and samples should be
at room temperature before they can be used.
♦ Bear in mind that also the samples are altered if exposed to air for more than 30
minutes.
♦ The buffer bottle must always be closed after the ISE determinations, as the CO2 in the
solution degrades when exposed to air for more than three days. If CO2 slope should
drop below 15, then replace the buffer solution and calibrate again. If the slope is still
low even with a new buffer, then replace the electrode.
♦ If one of the two solutions, buffer or reference, is replaced, then the calibration should
be performed again to avoid possible incorrect results.
♦ If the electrodes are removed for any reason, then carefully note down the electrodes
sequence positions. The potassium electrode (K) must be immediately detached (by
disconnecting tube) from the next electrode (Na) in the stack and maintained in vertical
position, because even a small reflux of liquid from Cl and CO2 electrodes can destroy it.
Carefully observe the liquid flow direction in the ISE module fluidic circuit. Liquid’s flow
should be clockwise, while hydraulic pump should rotate counterclockwise.
♦ The electrodes should be washed every day, even if the ISE module has not been used
for some time. This makes the electrodes more stable and guarantees a longer life.
1.9. SUGGESTIONS FOR PERFORMANCE MAINTENANCE.
To eliminate any problems during ISE operation, observe the following suggestions:
Before a long period of system’s inactivity, proceed as follows:
a) Perform an extra wash (refer to Chapter H, paragraph 1.1.1.), even if no ISE
determination has been performed.
b) Run " Prime I.S.E." and repeat it three times (refer to Chapter H, paragraph 1.1.1.).
c) At the end of this operation, release tube 5 (Figure 11) from the peristaltic pump and
remove the tubes from the pinch valve to avoid sticking and collapsing of tubes.
NOTE:
In case the ISE module has the Cl and CO2 electrodes, then also disconnect the tube 2 connected to K electrode (see
Figure 11).

After a long period of system’s inactivity, perform the following:

a) Connect tube 5 to the peristaltic pump, insert tubing into the pinch valve and connect
the tube 2 to K electrode.
b) Run " Prime I.S.E." and repeat this procedure for three times (refer to Chapter H,
paragraph 1.1.1.).
CAUTION
Refer to the Troubleshooting guide in case of problems during system restoring.
Turning off BT3000 PLUS system equipped with ISE Module
During turning off procedure, the analyzer requests whether the cuvettes and the ISE
Module should be washed (with Cleaning Solution and Enzymatic Solution). In case of an
affirmative response, the analyzer will wash both cuvettes and electrodes, otherwise it is
possible to wash the cuvettes only and not the ISE module or vice-versa by clicking the
appropriate icon in the “Analyzer Utilities” menu.
NOTE:
It is important to wash electrodes everyday even if the ISE Module has not been used. This makes the electrodes more
stable prolongs their life.

1.10. TROUBLESHOOTING
If the routine maintenance is performed regularly, the ISE module functions correctly. The
most common problems encountered in the ISE Module are as follows:

a) Calibration errors.
b) Unreliable sample results with flags.
c) Error messages of air bubbles.

a) CALIBRATION ERRORS
The causes may be due to various reasons and can be diagnosed through close
examination of mV values of slopes.

Typical values of calibration potentials in mV:

K std low = -8 mV
std high = +22 mV difference 30 mV (slope 57 mV)
Na std low = -10 mV difference 15mV (slope 63 mV)
std high= + 5 mV

Cl std low = +6 mV difference 10mV (slope 50 mV)

std high = -4 mV

CO2 std low = +4 mV difference 10mV (slope 32 mV)

std high = - 6 mV

The above-mentioned values are indicative and may deviate due to the wear and tear of the
electrodes.
A positional error or an incorrect concentration of reagents may determine a considerable
variation of potentials and slopes.
The mV values (in brackets) in the calibrations printout can give additional indications,
which are useful for the diagnostics.

For example:
Std low -8mV (-208 -200)
Std high +22mV (-178 -200)

One can observe in the above example the Baseline value (-200), which must be always
included between two Std values. In fact the value -200 is between the two values -208 and
-178.

Various combinations of error

a) Inversion of Buffer / Baseline
Considerable increase of potentials (up to 100mV), decrement of slopes.
b) Insertion of identical reagents: Buffer / Buffer or Baseline / Baseline.
The potentials are almost within norms but there is considerable decrement of
slopes.
In the above items a) and b), the Baseline values shown in the preceding example shall not
be coherent.

Obstructions caused by proteins in electrodes Cl &CO2

After approximately 150 to 200 samples, the Cl & CO2 electrodes may be periodically
obstructed. In this case, one observes an increase in the slopes of K & Na, and decrement
in the slopes of Cl & CO2. Follow the instructions for the cleaning of electrodes.
A similar error may also be caused by a partially occluded Ground electrode.
Generally, the obstructions are caused by the foreign matter and not by protein. Carefully
observe the cleaning procedures as outlined in the Figures 13 and 14 on the ensuing
pages.
NOTE:
A prolonged obstruction of the Cl electrode may progressively obstruct the electrodes
below it (CO2 and Bypass). For cleaning these electrodes, use syringe for the CO2 and the
cleaning tool on the Bypass as shown in the Figure 14.
b) BAD RESULTS OF SAMPLES:

Generally, this phenomenon occurs during sampling but it may take place afterwards.
Observe the above-mentioned diagnostic procedures.

c) ERROR MESSAGES, AIR BUBBLES, FLAGS

During a calibration or a run an error message "Air bubbles" may appear. The error may be
momentary and not appear afterwards. In this case, it means a casual formation of bubbles.
If it persists then it may be due to problems of hydraulic nature.
a) ISE funnel takes long time to empty. It may be caused by defective or worn
peristaltic pump for draining or an obstruction in the electrodes stack. Repair or
replace.
b) Prime operation failure. The Prime also calibrates the bubble sensor. Check that
prime is performed properly.
c) Collapsed tube in the ISE pinch-valve. The Baseline solution doesn't enter the
Reference electrode and the funnel doesn't empty. The Reference electrode is
filled during the prime. Check and correct.

Results with flag " D"

During the reading, the flag "D" on one or more electrodes indicates a drift of potential
greater than 2 mV. The phenomenon may be determined by one of the following causes:
• Defective electrode.
• Electrode to be reconditioned.
• Partial occlusion of the electrode.
• Incorrect reagents.
• No washing after a consistent run.
• Correlation with general problems already explained.
 NOTICE
CHL ORIDE EL ECTRODE
NEEDLE TOOL P/N 03254

It is often possible to extend the life of a chloride electrode by using the supplied CHLORIDE
ELECTRODE NEEDLE TOOL.

1) Grasp the NEEDLE TOOL as shown. Gently insert the tip of the needle tool into either end of
electrode. Keeping your fingers off the opposite end of electrode, slowly but firmly push the
needle straight through the electrode's inner core until the needle tip appears at the other
end of the electrode (be careful not to bend the needle inside the electrode). Wipe off any
debris on the needle tip and gently pull the needle back out of the electrode. Wipe off the
needle and remove any debris or moisture from the electrode surface.

2) Reinstall the electrode into the electrode housing in the correct order.
3) Install the electrode housing into the ISELyte Analyzer. Connect tubing and prime the ISE
module completely. If the electrode's performance does not improve, contact your local
Technical Support.
WARNING
NEEDLE TOOL can damage all other electrodes (K, Na, CO2, REF). Do not use!

Chloride Electrode Cleaning Procedure

F i g u r e 13
 NOTE:
FOR CONVENIENCE SAKE, IT IS IMPORTANT TO DETACH THESE
ELECTRODES IN SMALL GROUPS FROM THE REST TO AVOID POSSIBLE
ACCIDENTAL DAMAGE WHEN HANDLING A LONG STRING OF
ELECTRODES. OBSERVE THE CLEANING PROCEDURE OUTLINED HERE
FOR OTHER ELECTRODES.

GND
Electrode

REF
Reference
Electrode
BI-DISTILLED
WATER

CLEANING TOOL, P/N 03254

REFERENCE
REFER TO INSTRUCTIONS IN SOLUTION
THE FIGURE 13

Na Sodium
Electrode
K Potassium
Electrode
Cl Chloride
Electrode

CO2 Carbon
Dioxide
Electrode
REF
Reference
Electrode

CLEANING PROCEDURE
1) Carefully insert the tip of 5ml - 10 ml syringe filled with
appropriate solution onto the top duct of electrode
assembly as shown.
2) Inject solution until all the solution is forced through
interconnecting bores of the electrodes and flows out from
the bottom electrode, thus thoroughly removing any
contamination.
WARNING
a) PUSH THE PLUNGER ONLY TO EJECT THE SOLUTION. DO
NOT PULL THE PLUNGER TO ASPIRATE THE SOLUTION
INSIDE ELECTRODES. THIS WILL CAUSE IRREPARABLE
DAMAGE AND CONTAMINATION TO THE POTASSIUM
ELECTRODE WITH Cl OR CO2 PARTICLES.
b) DO NOT USE PLASTIC STRING FOR CLEANING THE
REFERENCE OR Na ELECTRODES AS IT MAY DAMAGE
THE ELECTRODES INTERNALLY

ISE ELECTRODES CLEANING PROCEDURE

Figure 14
 OPERATOR MANUAL
BT3000 PLUS

SECTION I: GENERAL INFORMATION

CHAPTER M
1. WARNINGS AND PRECAUTIONS
1.1. Potential risks during operation and maintenance Page: 2
1.2. Warnings and precautions Page: 3
1.3. Waste disposal Page: 6
1.4. Safe disposal of the unusable instrument Page: 6

Biotecnica Instruments S.p.A.

Via Licenza, 18
1. WARNINGS AND PRECAUTIONS

1.1. POTENTIAL RISKS DURING OPERATION AND MAINTENANCE

USE
Although the BT3000 PLUS analyzer system uses high performance components, which
provide a high degree of safety, it is essential that the user takes the usual precautions to
safeguard himself and to ensure a safe working environment.
Biotecnica Instruments S.p.A. only guarantees the workmanship and materials of its
products. It is the duty of the user to take care of safe operation and no amount of
warnings can take place of such care.
As regards the moving parts in the analyzer, these have been appropriately protected to
avoid any potential risks to the user, and for proper instrument operation and safety.
However, it is highly recommended to exercise extreme care during analyzer operation
and especially when working close to the devices.
To avoid accidental contamination, use suitable guards and/or personal protection, such
as overall and gloves. When handling reagents, it is advisable to observe good
laboratory practice (GLP) rules.
Chemicals, serum samples and reagents must be handled with extreme caution. Patient
samples may be biologically hazardous. The reagents or any other substances that may
enter in contact with samples should be treated in the same way as samples themselves.
The materials of human origin, such as control sera, are tested for the detection of
HbsAg, anti-HCV anti-HIV-1 anti-HIV–2 antibodies. Even if the result is negative, as
no known analytical method can exclude any infection’s risk with certainty
therefore these materials must be considered as potentially infective and thus
must be handled with extreme caution. The reagents and any other substance
entering in contact with samples must be treated in the same way. The reagents must be
manipulated (before, during and after the use) by qualified personnel familiar with their
characteristics in order to safeguard the user as well as the quality of the reagent itself.

MAINTENANCE
• It is of extreme importance that the instrument is fully turned off and the power cord
unplugged from the wall outlet to safely perform any maintenance or service
procedure.
• During maintenance procedures (see " Chapter N, “ Maintenance“ ), the safety and
warning precautions must be observed as outlined in the preceding paragraph.
• The exterior of the analyzer casing may be cleaned periodically to remove dust
grease and other contamination. It is not necessary to clean the inside. Use soft cloth
dampened with a mild solution of detergent with water.
• The owner shall be responsible for maintenance of the analyzer. Wear or damage
caused by lack of normal maintenance or by misuse of the analyzer shall not be
considered as defective workmanship and material.
1.2. WARNINGS AND PRECAUTIONS
The following warnings will aid the user to provide adequate safeguards to assure
safe trouble-free performance:
1. BEFORE OPERATING THIS SYSTEM, BE SURE TO READ THE OPERATOR MANUAL
THOROUGHLY AND CAREFULLY. AFTERWARDS, KEEP IT HANDY FOR FUTURE
REFERENCE.
2. TAKE SPECIAL CARE TO FOLLOW THE WARNINGS AND CAUTIONS INDICATED ON
THE SYSTEM REAR PANEL AS WELL AS IN THE OPERATOR MANUAL.
3. SYSTEM’S USE SHOULD BE RESTRICTED TO LAB’S QUALIFIED PERSONNEL ONLY.
4. SLOTS AND OPENINGS IN THE CASE, BACK PANEL, AND BOTTOM ARE PROVIDED
FOR VENTILATION. THIS ENSURES RELIABLE OPERATION OF THE SYSTEM AND
TO PROTECT IT FROM OVERHEATING. DO NOT BLOCK OR COVER THESE
OPENINGS.
5. BEFORE USING THE SYSTEM, CHECK THAT THE VOLTAGE ON THE REAR PANEL
LABEL MATCHES THE LOCAL LINE VOLTAGE.
6. TO GUARANTEE SAFETY THE SYSTEM MUST BE GROUNDED. THE WIRES IN THE
MAINS POWER CORDSET ARE COLORED IN ACCORDANCE WITH THE FOLLOWING
CODES:
GREEN AND YELLOW: EARTH
BLUE: NEUTRAL
BROWN: LIVE
THE WIRE COLORED BLUE IS INTERCHANGEABLE WITH WIRE COLORED BROWN.
IN CASE OF DOUBTS CONTACT THE NEAREST SALES/SERVICE OR A QUALIFIED
ELECTRICIAN.
7. REPLACE FUSE AS MARKED (see Chapter N, " Maintenance" ). PRIOR TO THE
REMOVAL OF ANY FUSE, TURN POWER OFF AND UNPLUG THE CORDSET FROM
THE WALL.
8. UNDER NO CIRCUMSTANCES IS THIS INSTRUMENT CASE TO BE OPENED. THIS
INSTRUMENT IS NOT USER SERVICEABLE. DANGEROUS HIGH VOLTAGES INSIDE
THIS INSTRUMENT CASE. IN EVENT OF DIFFICULTY, PLEASE NOTIFY YOUR
DEALER FOR PROMPT SERVICE.
9. FOR OPERATING SAFETY, DO NOT INSTALL THE SYSTEM IN A LOCATION WHERE
IT WILL BE EXPOSED TO HEATING EQUIPMENT OR RADIATORS, DIRECT SUN
LIGHT, OR ANY OTHER SOURCE OF EXTREMELY HIGH TEMPERATURES.
10. DO NOT OPERATE THE SYSTEM IN THE PRESENCE OF FLAMMABLE FLUIDS OR
GASEOUS ATMOSPHERE, DISINFECTING AGENTS, CLEANING AGENTS, ETC., DUE
TO POSSIBLE FIRE OR EXPLOSION.
11. DO NOT KINK, BEND, LAY OBJECT ON, OR OTHERWISE DAMAGE OR RESTRICT
CABLES AND TUBES.
12. BE SURE THAT THE POWER SWITCH ON THE BACK PANEL OF SYSTEM IS OFF
WHEN PLUGGING IN, OR REMOVING THE POWER CORDSET FROM A WALL
OUTLET.
13. TURN OFF THE MAINS POWER SWITCH ON THE REAR PANEL WHENEVER THE
SYSTEM IS NOT IN USE. THIS PREVENTS DAMAGES DUE TO SURGE IN THE MAINS
POWER.
14. DO NOT ATTEMPT TO ALTER THE SHAPE OF ANY PART OF THE SYSTEM.
15. IF THE SYSTEM IS NOT OPERATING PROPERLY AND THE TROUBLE-SHOOTING
SECTION (refer to Chapter N, “ Maintenance” ) DOES NOT PROVIDE A SATISFACTORY
SOLUTION TO THE PROBLEM, THEN DO NOT USE THE SYSTEM UNTIL THE
DEFECTS ARE REMEDIED.
16. INSPECT ALL ACCESSORIES AND SYSTEM CORDS. DO NOT USE IF DAMAGE CAN
BE SEEN SUCH AS CUT INSULATION OR OUTER COVERING, FRAYED OR BROKEN
WIRES, CORRODED OR BROKEN CONNECTORS ETC.
17. TO REDUCE THE RISK OF FIRE OR ELECTRIC SHOCK, DO NOT ALLOW FLUIDS OR
ANY FOREIGN OBJECT TO ENTER THE SYSTEM. WIPE OFF SPILLS IMMEDIATELY.
18. DO NOT USE BENZENE, THINNER, ANY KIND OF SOLVENTS, OR ABRASIVE
DETERGENTS TO CLEAN THE CASE. CLEAN WITH SOFT DUSTING CLOTH
DAMPENED WITH DISTILLED WATER. IF NECESSARY USE ONLY NEUTRAL
DETERGENT.
19. DO NOT STICK OBJECTS OF ANY KIND INTO THE SYSTEM THROUGH BACK PANEL
OR CASE SLOTS AS THEY MAY TOUCH DANGEROUS VOLTAGE POINTS OR SHORT
OUT PARTS THAT COULD RESULT IN FIRE OR ELECTRIC SHOCK.
20. INSTALL THE SYSTEM IN SUCH A WAY THAT ADEQUATE VENTILATION IS
PROVIDED ALL AROUND TO PROPERLY DISSIPATE THE HEAT.
21. USE ONLY ORIGINAL TUBING REPLACEMENTS-" MONTHLY AND QUARTERLY
REPLACEMENT KITS" . DO NOT USE CONVENTIONAL TUBING. THIS WILL CAUSE
MALFUNCTION OF THE SYSTEM.
22. MAKE SURE ALL FLUID LINES ARE FREE OF KINKS, NICKS, SHARP BENDS,
PUNCTURES, OR OCCLUSIONS BEFORE INSTALLING ON SYSTEM.
23. DO NOT TWIST THE PERISTALTIC PUMP TUBING WHEN PLACING IN THE RACEWAY
OF THE PUMP ROLLER.
24. RELEASE THE PERISTALTIC PUMP TUBING WHENEVER THE SYSTEM IS UNUSED
FOR LONG PERIODS OF TIME.
25. IF IT IS NOT BE USED FOR SOME TIME, THE PINCH-VALVES TUBING SHOULD BE
RELEASED.
CAUTION
THE HYDRAULIC CIRCUIT SHOULD BE FULLY DISCHARGED AND THE WATER RESERVOIR
DISCONNECTED FROM THE CIRCUIT PRIOR TO RELEASING THE TUBES FROM THE PINCH
VALVES. IF THESE STEPS ARE NOT TAKEN, SERIOUS DAMAGE MAY BE CAUSED TO THE
ANALYZER.
26. THE HALOGEN LAMP MUST BE REPLACED SOME MINUTES AFTER THE
INSTRUMENT HAS BEEN TURNED OFF AND POWER CORD UNPLUGGED (refer to
Chapter N, “ Maintenance” ).
27. ALWAYS ALLOW THE BURNT OUT LAMP TO COOL DOWN BEFORE HANDLING OR
ATTEMPTING REPLACEMENT.
28. NEVER TOUCH THE LAMP OR THE REFLECTOR WITH BARE FINGERS. USE A RAG
WHEN CHANGING.
29. IF THE LAMP IS TOUCHED INADVERTENTLY DURING INSTALLATION, CLEAN THE
LAMP OR REFLECTOR WITH ALCOHOL AND DRY WITH A CLEAN, SOFT CLOTH
BEFORE BURNING. CONTAMINATION OF THE LAMP OR REFLECTOR MAY REDUCE
LAMP PERFORMANCE.
30. THIS LAMP EMITS UV (ULTRAVIOLET) RADIATION. PROLONGED EXPOSURE TO
THIS LAMP MAY CAUSE SKIN AND EYE IRRITATION.
31. THE ANALYZER SYSTEM MUST NOT BE DISMANTLED OR REPAIRED BY ANYONE
WHO HAS NOT BEEN QUALIFIED BY THE MANUFACTURER. INCORRECT WORK
MAY CAUSE FIRE OR IRREPARABLE DAMAGE TO THE SYSTEM.
32. DO NOT OVERLOAD ACCESSORIES POWER OUTLETS AND EXTENSION CORDS AS
THIS CAN RESULT IN FIRE OR ELECTRIC SHOCK.
33. DO NOT PLACE THE SYSTEM ON AN UNSTABLE CART, STAND, OR TABLE; THE
SYSTEM MAY FALL, CAUSING SERIOUS INJURY TO USER, AND SERIOUS DAMAGE
TO THE APPLIANCE. PLACE THE SYSTEM ON A STABLE, VIBRATION-FREE, LEVEL
TABLE OR CART.
34. USE ONLY SECURE POWER SOURCE TO PROTECT THE ANALYZER SYSTEM
AGAINST POWER SURGES. DISCONNECT TEMPORARILY THE ANALYZER POWER
CORD FROM THE WALL OUTLET IN CASE OF BAD ATMOSPHERIC CONDITIONS.
35. DO NOT USE VACUUM PUMP UNTIL THE TWO TRANSIT SCREWS (COLORED RED)
AT THE BOTTOM OF CABINET HAVE BEEN REMOVED (OLD VACUUM PUMP SYSTEM
P/N 662.0788 AND BY-PRODUCTS).
36. DO NOT OIL ANY PART OF THE SYSTEM.
37. EMPTY WASTE CONTAINERS WHENEVER THEY ARE FULL. ENSURE THAT THE
CONTAINER LIDS ARE SCREWED ON TIGHTLY TO PREVENT LEAKAGE OR
DISPERSION INTO THE ENVIRONMENT.
38. THE SAFE DISPOSAL OF THE ANALYZER WASTE MATERIAL WITH MINIMAL
ENVIRONMENTAL IMPACT IS THE RESPONSIBILITY OF THE USER.
39. DO NOT ATTEMPT TO REMOVE ANY PANELS OR COVERINGS OF THE ANALYZER
OR THE VACUUM PUMP SYSTEM WHILE THE SYSTEM IS IN OPERATION.
40. AFTER OPERATION/SERVICING, COVER THE SYSTEM WITH A PROTECTIVE
PLASTIC OR CLOTH SHEET.
41. DO NOT USE SOFTWARE DISKS OF UNKNOWN ORIGIN IN THE ANALYZER
COMPUTER AS THEY MAY INTRODUCE VIRUSES.
42. DO NOT USE THE COMPUTER OF THE ANALYZER FOR ANY OTHER PURPOSE THAN
THE ONE FOR WHICH IT IS DESIGNED FOR.
43. BE PARTICULARLY CAUTIOUS THAT NO PARTS OF YOUR BODY (e.g. FINGERS
HAIR, ETC.) OR LOOSE OBJECTS (e.g. CABLES, TUBING, ETC.) CAN BE TRAPPED
BY ANY MOVING OR ROTATING PARTS (e.g. SAMPLING ARM, PLATES, WASHER
MODULE, PUMP ROLLERS ETC.) OF THE ANALYZER SYSTEM.

NOTE:
a) The careful observation of the proceeding warnings should result in a long and satisfactory
performance. If the above-mentioned notices are not fully observed, then any form of warranty is
no longer valid and Biotecnica Instruments S.p.A. will not be responsible for any subsequent
damage or loss. (see Section II, 2 “ Warranty Conditions” ).
b) The information in this manual is based upon the hardware and software currently in use.
Biotecnica Instruments S.p.A. reserves the right to make software and hardware changes or
improvements for product enhancement without notice and without imposing any obligation upon
itself to install these changes or improvements on its products previously manufactured.
1.3. WASTE DISPOSAL
• To ensure environment health and safety, it is recommended not to discard the used
consumables, waste liquids or disposable maintenance kits into the environment.
• Insure that the disposal of waste material is done according to all applicable laws
and regulations.

1.4. SAFE DISPOSAL OF THE UNUSABLE INSTRUMENT

For the proper disposal of instrument that is obsolete, outdated, beyond repair, or unusable,
follow these steps carefully:
1) Remove all consumables from the instrument (test tubes, cups, bottles,
containers, fluidic tubing etc.), and thoroughly clean the instrument with an
approved disinfectant for decontamination.
2) Contact a firm specialized in "hazardous waste disposal" for safe instrument
disposal.
NOTE:
a. The manufacturer of the instrument assumes no responsibility for any breaches resulting from
the delivery of the analyzer to a third party for disposal.
b. The manufacturer of the instrument is not responsible for collection and safe disposal of the
instrument. The safe disposal of the instrument and its contents is the responsibility of the
user.
 OPERATOR MANUAL
BT3000 PLUS

SECTION I: GENERAL INFORMATON

CHAPTER N
1. MAINTENANCE AND CARE
1.1. Preventive maintenance and Extra Wash Page: 2
1.2. Replacing tubing and accessories Page: 3
1.3. Additional maintenances Page: 7
1.4. Cleaning the instrument Page: 9
2. MALFUNCTIONS Page: 10
2.1. Troubleshooting Page: 10
2.2. Screen messages Page: 11
2.2.1. Screen messages - Causes and remedies Page: 11
2.2.2. Messages requiring technical assistance Page: 14
2.2.3. Optical system verification messages Page: 16

Biotecnica Instruments S.p.A.

Via Licenza, 18
00156 Rome – ITALY
1. MAINTENANCE AND CARE

1.1. PREVENTIVE MAINTENANCE AND EXTRA WASH

Exercise extreme care to ensure that the system is regularly provided with proper maintenance
and care to avoid any problems and malfunctions, which can potentially generate erroneous
results. This will give longest life at lowest overall cost.
The maintenance is normally performed every six months or whenever the operating conditions
dictate it. The analyzer stores the number of run tests and a built-in maintenance software
alarm automatically alerts the operator through on-screen messages whenever any part needs
attention or replacement. Failure to follow proper maintenance and replacement procedures
may result in system malfunction.
EXTRA WASH:
This function is similar to the one performed daily, but it is performed with an aggressive
detergent. The analyzer at about the expiry of a month prompts this operation.
Place a bottle containing sodium hypochlorite solution (at 5%) in the position 40 of the reagent
plate as indicated in the on-screen message and activate the washing function. At the end
perform one or two washings of cuvettes using "Wash and fillup" function.
It is highly recommended to perform the Extra Wash whenever there is any uncertainty
regarding the execution of normal daily washings. A progressive accumulation of contaminants
inside the cuvettes may cause serious problems by slowly releasing them during the test runs.
The following simple steps serve as practical guidelines in establishing your care and
maintenance program:
CAUTION:
a) Completely empty hydraulic circuit, using the program outlined in the Chapter H, paragraph 1.1.,
“ Empty Fluidics” and wait until this operation terminates.
b) Always make sure that the mains power switch on the instrument is turned off and the power cord
is unplugged from the wall outlet before performing any maintenance procedure.
1) Replace the worn out component soon after the on-screen message from the maintenance
software has been displayed (Figure 1 “Show Diagnostic”). To access this function refer to
chapter H.
2) Any consumable part showing signs of wear or damage should be immediately replaced,
even if the appropriate on-screen message is not already displayed.
3) Use only original Biotecnica parts. Do not replace defective parts with non-original parts as
this will cause malfunctioning of the analyzer. In case of any doubt, contact the Biotecnica
Instruments S.p.A. or nearest service center.
4) Use only bi-distilled water for the washes performed during working phases.
5) Use only Biotecnica Instruments S.p.A. approved wash solution for the washing procedures
at the end of working session.
6) During routine maintenance, exercise extreme caution to avoid any contamination. When
replacing tubing, needle, or handling waste container etc. accidental contact with organic
liquid is possible. For individual safety, use suitable protective garments, such as overalls
and gloves (refer to Chapter M, paragraph 1.1. “Potential risks during use and
maintenance”).
The components that are most subject to wear are the fluidic tubing used in the pinch-valves,
the peristaltic pump cartridges and the photometric lamp.
The hydraulic circuit items, not mentioned in the maintenance table, should be considered as
non-consumable and should be replaced only by the qualified technical personal during service.
 Figure 1
1.2. REPLACING TUBING AND ACCESSORIES
The components that should be replaced are clearly indicated in the Figure 2. The items
that don't require replacement are not indicated for simplification.
There are three tubing and accessory kits for maintenance. A Bimonthly Maintenance Kit
for ISE tubing (ISE Module tubes ① A, ⑤ , ⑥ , and ⑦ should be replaced every two months
for error-free operation), Six Month Maintenance Kit (Reading Station, ISE Module, Vacuum
Pump System) for special tubes exposed to wear and tear, including pump cartridges etc.,
and an annual maintenance kit (Reading Station, ISE Module, Vacuum Pump System) for
an over-all maintenance.
When installing any tubing kit, it is important that the hydraulic circuit is empty. To avoid any
undesired liquid spills, disconnect the external water input before applying any maintenance
kit. Turn on the instrument and perform a washing cycle to evacuate all liquid in the
hydraulic circuit. When changing tubes, pump cartridge etc. follow the illustrative diagrams
(Figure 2) on the next page.
a) Reading Station (see Figure 2, " Reading Station" )

- Peristaltic Pump Tubing ④ : Remove both ends of the peristaltic pump tubing from
the diluter manifold. Squeeze the locking catches and remove the defective
cartridge. Place the new cartridge on the drive shaft and gently press to snap-fit.
Carefully attach the pump tubing to both fittings in the diluter manifold.
- Pinch-valve tubing replacement ① : Detach pinch-valve tube and discard it. Carefully
insert the tube through the perpendicular intake port down into side slot of the pinch
valve. Pressing of the black button on the front of pinch-valve facilitates insertion.
Carefully attach ends of pinch-valve tubing to appropriate fittings as shown in the
"Reading Station" in Figure 2.
- Washer aspiration tube ② : Detach defective tube and replace with new aspiration
tube.
- Washer H2O tube ③ : Remove and discard the old tubing. It is possible that a small
quantity of distilled water will flow out of the water reservoir. Immediately dry it after
the tube replacement. Carefully insert the new tubing into the pinch-valve and attach
the ends to the appropriate fittings of the water reservoir and the washer.
- Normally the reading cuvettes should be substituted only if it is impossible to clean
them properly or of they are damaged. After substitution with new cuvette/s it is
important to perform the FCC procedure for the recalculation of the correction factor
of the optical path. If the FCC procedure is not performed then it may result in an
optical transmission error of approximately ±3% max.
- After removing cuvette plate and then replacing cuvette/s on the cuvette plate, give it
a final inspection to make certain everything concerning cuvettes cleanliness and
integrity is satisfactory. Gently place the cuvette plate downwards onto the rotor. Be
sure it is uniformly seated and secure all the cuvettes by gently pushing downwards
until they bottom against the depth of the rotor. Do not force the any cuvette into
place in the cuvette plate, use a light pressure with thumb. Fasten the cuvette plate
securely by tightening all the mounting screws. To ensure that pressure is applied
uniformly, first tighten all mounting screws finger-tight and then tighten them in a
crosswise pattern. Do not use excessive force on the screws.
Note:
The cleaning of cuvettes is of special importance and demands the complete removal of all
contaminations from the inner surfaces. If the cuvettes are not regularly cleaned, then during the tests
the slow release of contamination deposits from the inner surfaces may cause serious problems of
contaminations and carry-over. In such situations it is highly recommended to perform thorough
washing of cuvettes using appropriate solution during extra wash followed by a washing cycle.
Consult factory for additional information regarding the washing procedure.

b) ISE Module (see Figure 2, " ISE MODULE" )

- To access the ISE Module tubing, remove the plastic lodging for the reagents. Slide
up the ISE electrodes panel to have an easy access to disconnect the waste tube
connecting peristaltic pump to the ISE Module (refer to chapter L, par.1.4).
- Replace the Y-shaped tubing set ⑦ by first inserting the single tube end into the
bubble sensor, and then connect it to the funnel located above. Insert the remaining
two tube attachments into the appropriate slots (K+ tube in the upper slot and the
REF tube in the lower slot) of the pinch valve and then correctly connect their ends to
the REF and K electrodes as shown in the figure. Verify correct tubing placement in
the pinch valves.
- Replace the ISE peristaltic pump tube ⑥ by connecting one end to the ground
electrode, then around the pump head, and the other end to the waste liquid
connector as illustrated.
- Connect tube ⑤ to the Co2 electrode (or By-pass) and the ground electrode.

- Replace peristaltic pump cartridge ④ as explained in the preceding "a) Reading

Station".
- Replace tube ① A connecting the peristaltic pump through pinch-valve to the dilutor.
 - Carefully lower the ISE electrodes panel back into place ensuring that the tube ⑥ is
free and not pinched or crushed by the panel.
After replacing tubes and accessories, turn on the analyzer. Insert the plastic lodging with
the reagent bottles containing appropriate products and run a few times the function
“ Dilutor prime” and “ Prime I.S.E.” (refer to Chapter. H, paragraph 1.1.1.) to prime the
hydraulic circuit.

c) Vacuum Pump System

From June 2004 onwards all BT3000 PLUS family analyzers are supplied with a new
vacuum pump system. Its performance characteristics are identical to the previous model.
For detailed description and installation/instructions refer to Chapter K, Section I, Vacuum
Pump System Installation/Operation.
This compact pump system is virtually maintenance-free and offers continuous duty
collection of waste liquids outside the analyzer. Does not require inconvenient peristaltic
pump cartridge and filter changes. The theoretical operating life of the pumps is between
4000 to 5000 hours, after that the service technician should substitute the pumps.
WARNING
a) DISPOSABLE GLOVES MUST BE WORN WHEN SERVICING THE VACUUM PUMP SYSTEM
WHERE HANDS MAY CONTACT POTENTIALLY CONTAMINATED WASTE MATERIALS.
b) THE SAFE DISPOSAL OF THE WASTE MATERIALS IS THE RESPONSIBILITY OF THE USER.
INSURE THAT THE DISPOSAL OF WASTE CONTAINER FLUIDS IS DONE ACCORDING TO ALL
APPLICABLE LAWS AND REGULATIONS.
 4

7
2
1

WASHER/DILUITOR SYSTEM
BT 3000 PLUS
(READING STATION)
4

1A

I.S.E. MODULE
BT3000 PLUS

Figure 2

BIMONTHLY MAINTENANCE KIT (P/N. 662.1016)

ITEM QTY DESCRIPTION
1A 2 Diluter/Pinch Valve Tube ISE
5 1 Interconnection Tube for GND/Bypass OR CO2 Electrode
6 1 ISE Pump Tube
7 1 REF - K Tube Manifold
 SIX MONTH MAINTENANCE KIT (P/N. 11-05219-01)
ITEM QTY DESCRIPTION
1 2 Diluter/Pinch Valve Tube
1A 2 Diluter/Pinch Valve Tube ISE
2 1 Aspiration Tube for Washing Module
3 1 H2O Tube for Washing Module
4 2 Peristaltic Pump Cartridge
5 1 Interconnection Tube for GND/Bypass OR CO2 Electrode
6 1 ISE Pump Tube
7 1 REF - K Tube Manifold

ANNUAL MAINTENANCE KIT (P/N. 11-05220-01)

ITEM QTY DESCRIPTION
1 2 Diluter/Pinch Valve Tube
1A 2 Diluter/Pinch Valve Tube ISE
2 1 Aspiration Tube for Washing Module
3 1 H2O Tube for Washing Module
4 2 Peristaltic Pump Cartridge
5 1 Interconnection Tube for GND/Bypass OR CO2 Electrode
6 1 ISE Pump Tube
7 1 REF - K Tube Manifold
8 1 Tubular Filter for Water Container
9 2 Sampling Needle

Table of Figure 2

1.3. ADDITIONAL MAINTENANCES

a) Photometric lamp replacement
The analyzer controls the Halogen lamp condition, and it should be replaced annually or
when there is a faulty operation. The analyzer verifies lamp efficiency and stability, and
alerts the user through appropriate messages in case of fault. (see Figure 3, 4 & 5)

Figure 3 Figure 4
 4
3

1
2

REPLACING THE HALOGEN LAMP

Figure 5

Precautions for handling the halogen lamp:

• Turn off power and remove the power cord from the wall outlet before servicing. The
replacement of the Halogen lamp can be done by the removal of the rear panel, or by sliding
the transparent shutter on the front panel and then removing the access cover from the deck
(Figures 3,4 & 5).
• Always allow the burnt out lamp to cool down.
• Never touch the reflector or the lamp with bare fingers. Use a rag when changing.
• If the lamp is touched inadvertently during installation, clean the lamp or reflector with alcohol
and dry with a clean, soft cloth before burning. Contamination of the lamp or reflector may
reduce lamp performance.
• It is recommended to initially burn the new lamp for about 30 minutes before analyzer
operation.
Release the lamp assembly by gently sliding downwards. Loosen the front screws ❷in the
socket ❸and remove the burnt out lamp ❹.
Insert a new halogen lamp fully into the socket and firmly tighten the screws to secure the
lamp. It is recommended to slightly press both of the lamps retaining spring clips ❶before
fitting the lamp. Slide the lamp assembly onto the light cone and orient the lamp socket in
the vertical position as shown in the Figure 5.

b) Tubular filter for external water container

Tubular
Filter

The analyzer does not monitor the maintenance of this

filter. It is included in the annual maintenance kit.
Replace filter when it malfunctions or totally occluded
(Figure 6).

Figure 6
c) Sampling arms and sampling tubes
The analyzer does not monitor the sampling arms maintenance. Two sampling needles
(refer to No. 12 in Table of Figure 2) are provided for yearly replacement (or when
necessary) in the annual maintenance kit.

SAMPLING NEEDLES

SAMPLING TUBES

Figure 7
To replace the needle, Loosen and remove retaining nut with needle from the needle
holder. Clean or substitute with new needle. Gently push in needle into the needle holder
until fully seated, Carefully remove the needle with retaining ring from the needle holder.
Clean or replace the needle and firmly secure to the needle holder with retaining ring.

1.4. CLEANING OF THE INSTRUMENT

It is a Good Laboratory Practice (GLP) to maintain the instrument in optimal operating
conditions. The instrument should be fully turned off and the power cord unplugged from
the wall outlet prior to performing any cleaning procedure.
The exterior of the analyzer casing may be cleaned periodically to remove dust grease and
other contamination. Use soft dusting cloth dampened with distilled water or a mild solution
of detergent with water. Do not use alcohol, solvents, or abrasives.
Use appropriate soft lintless cloth or tissues for LCD Display cleaning. Clean gently and
avoid excessive rubbing to prevent damage to the LCD Display surface. Do not use any
liquid that may damage the invisible matrix of the touchscreen.
Protective gloves and laboratory coats/gowns should be worn to prevent contamination
when cleaning the inside of the reagent chamber or serum plate chamber because of liquid
contaminants. Use appropriate disinfectant for the thorough cleaning and elimination of
biological residues.
Clean the cuvettes thoroughly with approved washing solution. Immediately eliminate any
traces of serum drops or liquid contaminants using appropriate disinfectant to avoid
difficulties associated with removal of dry and tenacious contaminations. Handle cuvettes
with protective gloves.
2. MALFUNCTIONS

2.1. TROUBLESHOOTING
The risk of encountering system malfunctions is very low if the routine care and
maintenance procedure (outlined in the previous chapter) and the instructions in the
operating manual are strictly observed. Refer to the troubleshooting guide below and the
subsequent text regarding symptoms and corrective actions.

SYMPTOMS CORRECTIVE ACTIONS

The instrument or one of its Verify that the UPS group is turned on, the electrical cables
peripheral devices does not are correctly connected and check the fuses. If fuses need
replacement then observe the following procedure:
turn on 1) Turn off the instrument by pressing the main switch on
the rear panel and unplug power cord.
2) Extract the fuse-holder (located above the main switch on
the rear panel) by gently opening the latch with a tool.
Discard the old fuses and replace with new fuses, which
match the selected voltage rating indicated on the rear
panel label. Insert the fuse-holder into the compartment
and push until its latch snaps back into the position (see
Figure 3, Chapter B).
Results are invalid or cannot Sampling imprecision due to dirt in the dilutor:
be reproduced due to residues 1) Disconnect dilutor tubes
2) Remove the two mounting screws on the transparent
in the dilutor. dilutor chamber and clean the piston with soft lintless
cloth dampened with alcohol. Rinse the chamber and
reassemble. Connect the tubes to appropriate ports.
Results are invalid or cannot be Sampling imprecision due to the presence of air in the
reproduced due to air in the hydraulic circuit. Probably caused by the clogged tubular filter
sampling system. in the external water container:
Check, replace Filter if necessary (Figure 6).
Sampling imprecision due to deteriorated tube in the dilutor
pinch-valve:
Inspect and replace Tube (Figure 2, No.1).
Sampling imprecision due to reagent or sample residues in
the sampling tube or in the needle:
− Inspect and replace Peristaltic Pump Cartridge (Figure
2, No.4).
− Check and replace the Sampling Needle (Figure 7).
− Check and replace the Sampling Tube (Figure 7). To be
replaced by qualified service technician only.
Sampling imprecision due to reagent or sample residues on
the external surface of the needle, with consequent
contamination during preparation:
¾ Remove Needle/s and clean them externally using gauze
soaked with alcohol (Figure 7).
¾ Check the efficiency of built-in devices for needle
cleaning. In case of vacuum pump malfunction refer to
items in "VACUUM PUMP SYSTEM" on the next page. in
this chapter. If the problem with vacuum pump still
persists or if there are any obstructions in the cleaning
devices, contact immediately the nearest Biotecnica
sales/service office.
 SYMPTOMS CORRECTIVE ACTIONS
Results are imprecise due to Vacuum pump malfunction or occluded washing piston.
insufficient cleaning or drying − In case of vacuum pump malfunction refer to items in
of the reading cuvettes. "VACUUM PUMP SYSTEM" below. If the problem with
vacuum pump still persists or if there are any obstructions
in the washing piston, contact immediately the nearest
Biotecnica sales/service office.
NOTE:
Check sampling/washing hydraulic circuit for leaks, which may
affect system performance.
Invalid results or cannot be Defective or burnt-out lamp.
reproduced. Inspect and replace the lamp, refer to item a) in paragraph
1.3. " Photometric lamp replacement" .
Invalid results or cannot be Perform all maintenance procedures and check all possible
reproduced without any causes described earlier in this chapter.
evident reason.
VACUUM PUMP SYSTEM
The vacuum pump is silent a) No power to the system. Power cord disconnected. Connect
the power cord.
and " Restart" green LED not b) Blown fuse/s. Replace with appropriate fuses as marked.
lit.
Audible alarm of intermittent Indicates vacuum level variation due to leakage in the hydraulic
circuit connection/s. Ensure that the waste tubes (blue and black
frequency, some flashing tubes connecting vacuum pump to the analyzer) are firmly
LEDs and the instrument in connected.
standby mode. During the analyzer operation, this phenomenon may be
considered normal, as there may be sudden variations in the
vacuum level during emptying of the reading cuvettes.
Audible Alarm of intermittent External waste container full. Empty the external waste container
and press “RESTART” button on the vacuum pump cabinet to
frequency with the LED on the continue the operating procedure and to reset the alarm.
waste probe lit.
Damaged Unit The unit has suffered severe shock such as being dropped. Do not
use the unit. Consult your nearest sales/service office regarding
repair.
Smoke, strange odor or noise Stop using the unit immediately and disconnect the power supply.
Consult your dealer regarding repair.

2.2. SCREEN MESSAGES

2.2.1. SCREEN MESSAGES - CAUSES AND REMEDIES

The BT3000 PLUS software has a built in Auto-diagnostic function, which is enabled during
normal working sessions. This function allows verification of any system malfunction or
lacking of any solution necessary for running the tests.
In presence of any system malfunction, an appropriate message is displayed on the screen
indicating the type of error and the suggested solution. The system goes into the standby
mode until the causes of error are eliminated and then the operation can be resumed from
where it stopped.
When anything necessary for test run is lacking (for example reagent or sample) an
appropriate message is displayed on the screen, sampling procedure for the missing
element is interrupted while the analyzer continues with the next working phases.
 SCREEN MESSAGE CAUSES & REMEDIES
The error “ SAMPLE IS MISSING” is displayed when the
SAMPLE IS MISSING analyzer detects the absence of sample through a built-
in liquid sensor. It is subdivided into NO ROUTINE, NO
NO ROUTINE XX STAT, NO STANDARD, NO CONTROL. After this
NO STAT XX message the sampling of the missing sample is
NO STANDARD XX interrupted. It is possible to run missing tests using the
NO CONTROL XX rerun commands (Chapter E, paragraph 1.5).
The error “ REAGENT IS MISSING” is displayed when
REAGENT IS MISSING the analyzer detects through a built-in liquid sensor the
absence of reagent needed for test run. After this
NO REAGENT XXX message the sampling of the missing reagent is
POSITION XX interrupted. It is possible to run missing tests using the
rerun commands (Chapter E, paragraph 1.5).

SPECIAL REAGENTS
SCREEN MESSAGE CAUSES & REMEDIES
NO I.S.E. BUFFER The error message “ NO ISE BUFFER” is displayed
when the analyzer detects through a built-in liquid
sensor the absence of ISE buffer solution needed for
programmed tests. Immediately after this message
the ISE sampling is interrupted. Insert new buffer. It is
possible to repeat interrupted tests using the Re-run
option (Chapter E, paragraph 1.5).

NO I.S.E. BASELINE The error message “ NO ISE BASELINE” appears

when the analyzer detects through a built-in liquid
sensor the absence of ISE reference solution
(Baseline) required for running programmed tests.
Immediately after this message the reagent sampling
is interrupted. Insert fresh reference solution
(baseline). It is possible to repeat interrupted test
using the Re-run option (Chapter E, paragraph 1.5).

NO I.S.E. WASHING The error message “ NO ISE WASHING SOLUTION”

is displayed when the analyzer detects through a built-
SOLUTION in liquid sensor the absence of ISE washing solution
and instantly the ISE sampling is interrupted. To
restart washing insert new washing solution bottle.

NO SAMPLE DILUENT The error message “ NO SAMPLE DILUENT” is

displayed when the analyzer detects the absence of
sample diluent solution and instantly the testing of
samples to be prediluted is interrupted. To solve the
problem add fresh diluent solution and re-run the
sample (Chapter E, paragraph 1.5).
 VACUUM PUMP SYSTEM
SCREEN MESSAGE CAUSES & REMEDIES
1) When the vacuum level drops below the preset level the
message "-WARNING- LOW PRESSURE" is displayed,
and instantly the sampling procedure is interrupted. To
continue the tests, it is important to solve the problem by
verifying items under "VACUUM PUMP SYSTEM" in
paragraph 2.1. in this chapter. After resolving the problem,
the analyzer can be restarted and continue testing from
where it stopped.
NOTE:
The message "-WARNING- LOW PRESSURE" may also appear
when waste liquid container is full. The vacuum pump system
- WARNING – connected to the analyzer automatically transfers waste liquids
into the waste container. Whenever the waste container is full
the level detector activated audio/visual alarm alerts the user.
LOW PRESSURE The audible alarms have two beep frequencies (slow/rapid).
When the external waste container is full, the vacuum pump
system generates slow intermittent beeps. The second alarm of
rapid intermittent beeps is activated when the waste chamber
inside the vacuum pump is full. When the first alarm sounds, the
analyzer will continue to function for about 4 minutes, until the
internal waste chamber is full, then it stops working.
2) Operative steps sequence in case of alarm:
First alarm on (slow intermittent beeps) and the waste
probe LED is lit.
External waste container full. Empty or replace it and press
" RESTART" button (Green) to continue the operating procedure and
to reset the alarm.
Second alarm on (rapid intermittent beeps) with the LED on
the waste probe lit.
The external waste container and the internal waste chamber are full.
The vacuum system stops itself, the analyzer interrupts working
phases and displays the message “ Low pressure…” . Empty or
replace the waste container and press the green “ RESTART” button
on the vacuum pump cabinet to continue the operating procedure
and to reset the alarm.
If the audible alarm is still activated, it means vacuum pump for
draining is not efficient or the defective 3-way solenoid valve and that
the internal waste chamber is still full. The vacuum system stops
itself, the analyzer interrupts working phases and displays the
message “ Low pressure…” . Consult your nearest sales/service
office regarding repair.
The message “ No Water …” appears when washing water does not
reach the analyzer because the external water container is empty or
defective loading pump. When this message is displayed, the
sampling procedure for programmed tests is stopped. Fill the
- WARNING - external water container to continue the tests. Check, replace if
necessary the tubular filter on the intake tube inside the water tank
NO WATER (item b), paragraph 1.3.). The analyzer will start working from where
it stopped (see Chapter E, paragraph 1.5.). If the error message
persists, because of defective loading pump, contact the approved
technical assistance.
THERE ARE THE The message “Extra wash” is displayed during normal working
sessions when the analyzer has been previously switched off without
FOLLOWING following the proper shutdown procedure (Chapter E paragraph
1.6.). Execute a washing procedure (Chapter H, paragraph 1.1.) to
OBLIGATIONS IN prevent continuous appearance of this message. This message does
DIAGNOSTIC: not stop test execution, but it is not possible to guarantee correct
results if an effective Extra Wash is not performed.
EXTRA WASH
2.2.2. SCREEN MESSAGES REQUIRING TECHNICAL ASSISTANCE
SCREEN MESSAGE CAUSES & REMEDIES
This message stops the execution of programmed
tests. The message “ ERROR RESETTING SAMPLE
TRAY” is generated by an incorrect home position of
ERROR RESETTING the sample tray. This error can be caused either by an
SAMPLE TRAY absence of sample tray, or defective position sensor.
In case of a wrong positioning or absence of sample
tray, correctly position the sample tray in its chamber
and then press “ F5” (“ Reset” ) key to restore correct
analyzer operation. In case of defective position
sensor contact qualified technical assistance to solve
the problem.

This message stops the execution of programmed

tests. The message “ ERROR RESETTING
REAGENT TRAY” is activated by an incorrect zero
positioning of the reagent tray. This error can be
ERROR RESETTING caused either by an incorrect placement of reagents
REAGENT TRAY tray into the analyzer or by a defective position
sensor. Verify and correctly place the reagents tray
and then press “ F5” (“ Reset” ) key to restore correct
analyzer operation. In case of defective position
sensor contact qualified technical assistance to solve
the problem.

This message stops the execution of programmed

tests. The message “ ERROR RESETTING
DILUTOR” is generated by an incorrect zero
positioning of the dilutor piston. This error can be
ERROR RESETTING caused either by an excessive piston friction or a
DILUTOR defective position sensor. In the event of friction it is
sufficient to disassemble and clean the piston with a
soft cloth dampened with alcohol, reassemble and
then press “ F5” (“ Reset” ) key to restore correct
analyzer operation. In case of defective position
sensor contact approved technical assistance to solve
the problem.

This message stops the execution of programmed

tests. A position sensor error of the cuvette tray
ERROR RESETTING generates the message "ERROR RESETTING
CUVETTE TRAY CUVETTES' TRAY". Press “ F5” (“ Reset” ) key to try
to restore the correct operation of the analyzer. If this
does not solve the problem, then it will be necessary
the to contact approved technical assistance.
 SCREEN MESSAGE CAUSES & REMEDIES
This message stops the execution of programmed
ERROR RESETTING ARM tests. The message “ ERROR RESETTING ARM
ARM (HORIZONTAL) (HORIZONTAL)…” is generated by a defective
position sensor of the arm. Press “ F5” (“ Reset” ) key
to restore the correct analyzer operation. If the
ERROR RESETTING I.S.E. problem persists, then contact approved technical
ARM (HORIZONTAL) assistance.

This message stops the execution of programmed

tests. The message “ ERROR RESETTING ARM
ERROR RESETTING ARM (VERTICAL)” is generated by an error during
(VERTICAL) up/down motion the sampling needle. This error may
be caused by a deformed needle, obstructions (i.e.
improper placing of the reagent bottles) or a defective
ERROR RESETTING ARM position sensor. If the needle is deformed, replace it.
I.S.E. (VERTICAL) As regards obstructions, just place the bottles
correctly. Afterwards press “ F5” (“ Reset” ) key to
restore correct analyzer operation. In case of
defective position sensor, contact approved technical
assistance.

This message stops the execution of programmed

tests. A defective position sensor of the washer
ERROR RESETTING module generates the message " ERROR
WASHING STATION RESETTING WASHING STATION" . Press “ F5”
(“ Reset” ) key to restore correct analyzer operation. If
the message persists, contact approved technical
assistance.

The message “Impossible to reset analyzer” indicates

a system error. It does not allow the continuing of
IMPOSSIBLE TO RESET working phases. Restart the system computer by
ANALYZER pressing the start button located under the LCD
screen. If the message persists, contact approved
technical assistance.

The message “Synch” indicates a system error. It

does not allow the continuing of working phases.
SYNCH ERROR Restart the system computer by pressing the start
button located under the LCD screen. If the message
persists, contact approved technical assistance.

The message “System blocked” indicates a total

SYSTEM BLOCKED blockage of the system. Restart the system computer
CALL ASSISTANCE by pressing the start button located under the LCD
screen. If the message persists, contact approved
technical assistance.
2.2.3. OPTICAL SYSTEM VERIFICATION MESSAGES

ERROR MESSAGE CAUSES & REMEDIES

The message “ LAMP PROBABLY OFF” is displayed
after a photometric zeroing, when the analyzer detects
that the optical system has a lower efficiency than
- WARNING - the minimum value stored. When this message is
LAMP PROBABLY OFF displayed it is not possible to continue sampling tests.
Replace photometric lamp (see item a) in paragraph
1.3.) and perform Photometric Zeroing (refer to
Chapter H paragraph 1.1.1.). In case the error
message still persists, contact approved technical
assistance.

The message “ LAMP EXHAUSTED” is displayed

after a photometric zeroing, when the analyzer detects
that the optical system has a lower efficiency than
the minimum value stored. The sampling tests are
- WARNING - stopped instantly after this message. Replace the
LAMP PROBABLY photometric lamp (see item a) in paragraph 1.3.) and
then perform an “ Extra wash” . Afterwards perform a
EXHAUSTED “ Wash and Fill Up” followed by a new Photometric
Zeroing (refer to Chapter H paragraph 1.1.1.). If after
observing these steps, the message no longer
appears, then it is possible to continue testing.
In case the error message still persists, contact
approved technical assistance.

The message “ERROR IN OPTICAL GROUP” is

ERROR IN OPTICAL displayed after resetting the analyzer and indicates an
GROUP optical group malfunction. Contact approved technical
assistance.
CUVETTES The message “ CUVETTES TRANSMISSION OUT
TRANSMISSION OUT OF OF LIMITS” is displayed after a photometric zeroing,
LIMITS when the analyzer detects optically unusable
cuvettes. The sampling tests are stopped instantly
after this message.
Replace the photometric lamp (see item a) in
paragraph 1.3.) and then perform an “ Extra wash” .
Afterwards perform a “ Wash and Fill Up” followed by
a new Photometric Zeroing (refer to Chapter H
paragraph 1.1.1.). If after observing these steps, the
message no longer appears, then it is possible to
continue testing.
In case the error message still persists, contact
approved technical assistance.

IMPORTANT NOTICE:
The above-mentioned messages are only a partial representation of all the possible warnings that the
analyzer may output to the user. In case of any messages that are not covered here or are not clear,
please contact Technical Assistance Dept. at Biotecnica Instruments S.p.A.
 OPERATOR MANUAL
BT3000 PLUS

SECTION I: GENERAL INFORMATION

CHAPTER O
1. TECHNICAL SPECIFICATONS Page: 2

NOTE:
Specifications are subject to change without notice

Biotecnica Instruments S.p.A.

Via Licenza, 18
00156 Rome – ITALY
1. TECHNICAL SPECIFICATIONS

PERFORMANCE

Operating Mode “Random access”

Methods Tests for Clinical Chemistry and Immune-Chemistry
ISE Module Na, K, Cl (CO2 optional)
Test Mode Routine, Batch, Emergencies (STAT), Profiles
Tests on line 80 refrigerated reagents + Relation Tests
Tests in memory 500 single or double- reagent + unlimited Relation Tests
Test Re-runs automatic or on demand
Calibrations and Controls automatic or on demand
Automatic Profiles automatic execution of related profiles or on demand
Measurement direct reading of 34 cuvettes in optical glass
Sample Tray Capacity 52 positions for Samples & STAT, 26 for Standard and Controls
Bar code scanner 2 distinct readers for positive identification of samples and reagents
TIME REQUIRED TO REACH STEADY STATE
Ambient conditions: 21 °C R.T., 33% RH
Time required for the analyzer to reach steady state: 20 min.
Ambient conditions: 21 °C R.T., 33% RH
Time required for refrigerated bottles to reach steady state: approximately 2 hours

CLINICAL CHEMISTRY
Sampling Cycle: 11 seconds
Analytical throughput: 330 tests/hour single reagent
Test processing time max 360 seconds
ISE PROCEDURE
ISE Test processing time: 70 seconds
Executive throughput: 51 Samples/hour
Analytical throughput: 204 Results/h (K+, Na+, Cl- and CO2)

CUVETTE OPERATING TEMPERATURE

Programmable Temperatures: Room Temperature, 32 °C, and 37 °C
Precision ± 0,2°C - Accuracy ± 0,2°C
Temperature Monitoring Device based on Peltier Effect

REAGENT CHAMBER TEMPERATURE

Nominal Temperature: 11°C Approx.
Temperature Monitoring Device based on Peltier Effect

OPERATING AMBIENT TEMPERATURE

18 °C to 32 °C, 10% to 90% RH, Non condensating
DIMENSIONS AND WEIGHT NOTE: weight and dimensions shown are approximate

Packaged Instrument 135 Kg . (298 lb)

Packaged Instrument with Accessories 225 Kg. (496 lb)
Packaged Accessories 90 Kg. (199 lb)
Instrument’s Dimensions L = 100 cm (40") D = 58 cm (23") H = 68 cm (27")
Packaged Instrument’s Dimensions L = 120 cm (48") D = 80 cm (32") H = 80 cm (32")
Packaged Accessories’ Dimensions L = 120 cm (48") D = 72 cm (29") H = 70 cm (28")

ANALYZER POWER REQUIREMENTS

Universal Input: 90 / 240 V~, 50-60 Hz
Power: 590 Watt
PFC Unit (Power Factor Correction) included.

VACUUM PUMP POWER REQUIREMENTS

New " Vacuum Pump System" P/N 06-05161-01:
Input: 90/240 V~, 50-60 Hz
Power: 60 Watts
Previous " Vacuum Pump System" P/N 662.0788 - (OBSOLETE)
Input: 220 V~, 50-60 Hz (110 V~ on request)
Power: 80 Watts

PRINTER POWER REQUIREMENTS

Universal Input: 100 / 240 V~, 50-60 Hz
Power: 50 Watts
UPS (optional):
Input: 220 V~, 50-60 Hz (110 V~ on request)
Output: 220 V~, 50-60 Hz (110 V~ on request)
Power: 1100 VA (710 Watts)

ELECTROMAGNETIC COMPATIBILITY AND ELECTRICAL SAFETY

The BT3000 PLUS instrument has passed all tests related to Electromagnetic Compatibility (EMC),
and "Safety requirements for electrical equipment for measurement, control, and laboratory use"
performed by the OCE Lab (EMC & Electrical Safety Compliance Test Laboratory), Ministry of
Communication - Italy accredited EMC certification body, No. 051 of 21 October 1998. Certificate's
documentation is available on request. The BT3000 PLUS is in conformity with the following
normative/standards:
EN 61326: EMC
EN 61010-1: ELECTRICAL SAFETY

PHOTOMETER

Optical System Solid state photometry, (patented by Biotecnica Instruments S.p.A.)

Detectors 10 UV/VIS photodiodes + reference channel
PRECISION AND ACCURACY
Spectral Response: 340, 380, 405, 436, 480, 510, 546 578, 630, 700 nm
Bandwidth: ± 5 nm max
Photometric precision: ± 1% from 0 to 2.000 O.D., ± 2.5% at 2.400 O.D.
Photometric Sensitivity: ± 0.0005 ABS
Drift: ± 0.005 ABS/h (steady state)
Optical path: 7 mm
Photometric Lamp: Tungsten Halogen Lamp with Dichroic Reflector
Power: 35 Watts
Input voltage: 12 VDC
Avg Rated Life: Approximately 2000 hours
NOTE: For optimal result the lamp can be used for about 1,500 hours. The long-term use will result in the
gradual deterioration of the UV emission.

DILUTORS

Dilutors Type: Biotecnica Dilutor

TECHNICAL SPECIFICATIONS
Max Volume: 470 µl
Linearity F.S.: ± 0.1% F.S. (Full Scale)
Accuracy at 3 µl: ± 3%
Accuracy (Full Scale): ± 0.1% from 10 µl to 470 µl
Reproducibility ± 0.7% at 3 µl; ± 0.6% at >3 µl
Average Life: 3 million operating cycles
Maintenance: Every 300,000 operating cycles (O-ring seal replacement)

VOLUMES
WORKING SOLUTIONS
Clinical Chemistry
Reaction Volume: 280 µl minimum; 700 µl max. (double reagent)
Sample Volume: from1 to 100 µl
ISE
Concentrated Buffer Solution: 50 µl + 400 µl (H2O)
Concentrated Reference Solution: 50 µl + 400 µl (H2O)
Sample Volume: 30 µl
Concentrated Buffer 10 ml: 200 tests
Concentrated Reference Solution 10 ml: 200 tests
RESIDUAL VOLUMES OF REAGENTS BOTTLES
NEW SERIES
80 ml BOTTLES: 1 ml
50 ml BOTTLES: 1 ml
20 ml BOTTLES: 0.5 ml
10 ml BOTTLES: 0.5 ml

ISE MODULE
Number of electrodes: 4 plus Reference Electrode
Analytes: K+, Na+, Cl- and CO2 (optional)
Test processing Time for the ISE: 70 seconds.
Executive throughput: 51 Samples/h
Analytical throughput: 204 Results/h (K+, Na+, Cl- and CO2)
Reagents: Buffer and Reference Solution (concentrated)
Sample Type: Serum, Urine (Whole)
Sample Volume: 30 µl
Concentrated Reagents Dilution: 1/10 with H2O (automatically)
Dilution of Serum/ Buffer: 1/14 (automatically)
Precision on Serum test: ± 1% for K+, Na+
± 2% for Cl
± 3% for CO2
Precision on Urine test: ± 2% for K+, Na+ and Cl-
Linearity for Serum test: Na+ = 50-200mEq/L K+ = 1-20mEq/L
Cl- = 50-400mEq/L CO2 = 10-45mEq/L
Linearity for Urine test: Na+ = 20-400mEq/L K+ = 2-200mEq/L
Cl- =40-400mEq/L
Accuracy for Serum test:
Intra Run Serum (20 samples): Na+ and K+ C. V. < 1%
Cl- C. V. < 2%
CO2 C. V. < 5%
Infra Run Serum (N°20 samples): Na+ and K+ C. V. < 2%
Cl- C. V. < 2.5%
CO2 C. V. < 5%
Accuracy for Urine test:
Intra Run Urine (20 samples): Na+, K+ and Cl- C. V. < 2%
Infra Run Urine (20 samples): Na+, K+ and Cl- C. V. < 2.5%
+
Average Life of Electrodes: Na and Reference Electrode 12 months
K+ 3 months
Cl- & CO2 3 months

“ UTILITY” EXECUTION TIMES

Wash & Fill Up: 270 seconds (approximately)
Wash H2O: 180 seconds (approximately)
Zeroing: 420 seconds (approximately)
F.C.C.: 900 seconds (approximately)
Extra Wash I.S.E.: 800 seconds (approximately)
Extra Wash Cuvette: 540 seconds (approximately)
Wash Shut Down: 12 minutes (approximately)

WASH VOLUMES
Clinical Chemistry Washes:
H2O Single Wash of Cuvette: 5 ml (approximately)
H2O Single Wash of Needle: 2 ml (approximately)
Consumption per test: 7 ml (approximately)

H2O for Zeroing: 250 ml (approximately)

H2O Total Wash of Cuvette: 170 ml (approximately)
Extra Wash of Cuvettes: approx. 70 ml H2O + 13 ml Cuvettes Washing Solution

I.S.E. Washes:
H2O per test: 2 ml (approximately)
I.S.E. Extra Wash: 0.5 ml I.S.E. Washing Solution
0.5 ml Enzyme Solution
DATA MANAGEMENT
Computer > Pentium IV > 2400 MHz or more, IBM compatible
DVD/CD Rom Player > 16X
Hard disk >20 Gb
Floppy Disk Drive 1,44 Mb
Monitor LCD Display Module TFT 12” with integrated touchscreen
Interface 2 Serial Ports RS232C + 2 USB PORTS
Printer Ink-jet Color IBM compatible or other
Mouse & keyboard Cordless
External Modem Optional
Error Messages Visible (Vocal optional)

NOTE:
1 As regards the technical specifications for the system " instrumentation +
reagent" used in the applications of kit, these are the responsibility of kit’s
manufacturer and will be stated in the applications (refer to the instructions
accompanying the kits).

2 The analyzer BT3000 PLUS does not require (after sales) regular calibration and
mechanical adjustment procedures. There are mechanical and electronic
adjustments performed by the manufacturer (Biotecnica Instruments S.p.A.)
during assembly and quality controls. These adjustments may be performed
again in case required by a particular technical service and in any case are at
the discretion of the authorized technical personnel only. However, It is highly
recommended to check the system periodically to prevent any faults or
malfunction of the analyzer.
 OPERATOR MANUAL
BT3000 PLUS

SECTION II: ADDITIONAL INFORMATION

CHAPTER 1
1. ABBREVIATED OPERATING INSTRUCTIONS Page: 2
1.1. Turning on and preliminary procedures Page: 3
1.2. Inserting Reagents for Clinical Chemistry and ISE Page: 6
1.3. Analytical calibrations and Controls Page: 7
1.4. Entering Patients and Work Lists Page: 10
1.5. Running Tests Page: 14
1.6. Displaying and Printing Results Page: 15
1.7. Turning off the analyzer Page: 19

FOREWORD
This quick guide gives a global view of the system operation by outlining
the sequence of fundamental operating phases. It is highly
recommended to carefully read these instructions and allied information
in order to have a deeper knowledge of each argument.

Biotecnica Instruments S.p.A.

Via Licenza, 18
00156 Rome – ITALY
1. ABBREVIATED OPERATING INSTRUCTIONS

The BT3000 PLUS is an automatic analyzer for clinical chemistry,. immunochemistry analyses, and
for electrolytes determination of Na+, K+, and Cl- through Ion Selective Electrodes (ISE Module). It is
possible to add the CO2 electrode (optional) to the ISE Module. The instrument is a fully automatic
analyzer for processing serum, urine and plasma samples.
The analyzer can be divided into the following two distinct parts:
a) Sampling Unit: It prepares for tests the samples and single or double reagent.
b) Reading Unit: Cuvette plate with integral automatic washing system.

SYMBOLS
As the BT3000 PLUS analyzer software runs under Windows, it uses the same philosophy with
windows, icons, quick commands, function keys and curtain-shaped menus.
Every window has its own icons and specific menus that will be described hereafter. The full
meaning of each command will be explained in the corresponding chapters.
At the start-up the program will display the following main window:
2

6 7

① Main menu: Each menu generates additional commands and/or

options
② &③ Direct access icons: Selecting any icon the corresponding command
is directly activated.
④ Software version: Operating program version.

⑤ Access level: It is the password dependent access level allowed to the

operator.
⑥ Message bar: Clicking here opens a window showing messages
received by the program.
⑦ Errors bar: Clicking here opens a window showing the errors that
occurred during the work session.
1.1. Turning on and preliminary procedures.
1) Check that the UPS device is turned on.
2) Check that the printer is on and that there is enough paper in the tray.
3) To start the analyzer, press the mains switch on the rear panel of the instrument. This operation
turns on only the refrigeration chamber for the reagents. Start the computer, by briefly pressing
the push-button under the screen (Figure 1).
CAUTION!
Do not press this push-button during analyzer operation. Bear in mind that if this button is pressed again it
shuts down the analyzer (but not completely), leaving only the refrigeration chamber turned on. (refer to
Chapter E, paragraph 1.6. “ Turning off procedure” ).
4) Once turning on is completed (lasting approximately 1 minute), wait for the instrument to warm
up. During the warm-up period the LED bar indicator flashes until the proper temperature is
reached. The instrument reaches the steady state in approximately 20 minutes after power on.

5) Verify the presence of the washing liquid (at least

for the daily needs). It consists of bi-distilled H2O
plus surfactant (1ml/l of water - ratio 1/1000).
6) Verify that waste liquid containers are empty or at
least have the capacity to contain the quantity of
liquid produced during the working day.
NOTE:
It is important to observe steps 2), 5) and 6) to ensure a
continuous operation of the analyzer without interruptions.
START BUTTON
COMPUTER

Figure 1

Direct Access
Icon

¾ Run a dilutor prime by the command “ Dilutor

prime” (Fig. 2).
¾ Run a wash by the command “ Wash and fill
up” .
¾ After the instrument has been turned on for 20
minutes (warm-up time), run a photometric
zeroing by the command “ Zeroing on water” .

Figure 2
 SERVICE ICONS BAR

Reset Analyzer (F5)

Stand-by Analyzer (F6)

Displays the Volumes’ Status; Used to Insert/Remove Reagents (F10)

Password (F7)

Status Analyzer (F2)

Printer Setup (F4)

Help on line (F1)

FUNCTION ICONS BAR

1 - To Insert New Codes, Parameters, Standards and Controls for all Analyses

2 - To Create the On-Line Reagents’ Tray

3 - To Insert Parameters/ Standard and Controls for the On-Line Reagents

4 - To Insert/Modify Profiles

5 - To Insert Routine - View Programmed or In-Run Patients

6 - To Insert Batch

7 - To Run Standards

8 - To Run Controls

9 - Analyzer’s Utilities

10 - Mechanical Calibrations

11 - a) Results Listed per Patient b) Results per test in real time

 12 - No Results

13 - Reaction Graphs

14 - Turning ofF the System

Simply positioning the cursor on the icons the so called “hint” will appear (where available), showing
a brief description of the icon function. This is followed (when available) by the function key between
brackets, which allows for the same function or command as the icon. For example, the hint “Reset
(F5)” means that the function key F5 has the same function of the icon.
In the same way, in each menu are shown (when available) the quick commands (e.g. “Insert Batch”
(Ctrl+B) means that the same function is activated by typing simultaneously on the keyboard the
keys “Ctrl” and “B”).

GENERAL ICONS
Cancel (aborts the programming and closes the window)

Save (saves the program and closes the window)

Print (prints the window's contents, i.e. parameters, graphs etc.)

Reduces the window to the upper bar where the analyzer's name appears

Selections (clicking on the arrow opens a selections’ list)

Exit (exits from the window)

Closes the application or switches off the system

Windows commands:
Reduces the window to an icon (with ALT+TAB, it is possible to switch
between open applications, even if they are reduced to icons)

Closes a window or an application

Reduces the window to a single upper bar where only the analyzer’s
name will appear

An icon representing refrigeration system operation has been added to the status bar in the main
menu. The "Refrigerator disabled" state may be necessary if the operator decides not to use the
refrigerator for reactions or after a refrigeration operating error generated by the system.

Refrigerator enabled Refrigerator disabled

 Direct Access
1.2. Inserting Reagents for Clinical Chemistry and ISE Icon

Figure 3 Figure 3A
This function can be accessed either by pressing F10 key or by clicking on the specific
direct access icon. It assists the user in correct positioning of the reagent bottles, as programmed
in the current tray.
The reagent tray accommodates five removable sectors, identified by the letters A, B, C, D, and E.
Each sector has 8 positions. The screen displays the representation of 8+8 reagent bottles (Figure
3). The analysis codes that use large bottles are displayed in the lower positions, while the codes
using small bottles are displayed in the upper positions. The reagents volume status for the ISE
Module and the sample diluent are illustrated in the Figure 3A. The insertion of reagents in the
reagent tray for clinical chemistry, and in the ISE Module is shown in Figures 4 & 5 respectively.

Figure 5

Figure 4
Single bottle: Right-click over analysis code. Choose between bottle’s insertion or removal. The analyzer will
correctly position the tray to match with the arrow at the base of the tray itself. With bar-code option enabled,
identification is correctly accomplished through the automatic scan of the bar code on the inserted bottle. The
same function can be performed on demand, by activating the "Scan Bottle" command (near the
insertion/removal commands)
Whole sector: Right-click on the “SECTOR” field. Choose between bottle’s insertion or removal. The analyzer
will correctly position the whole sector for insertion or removal. With bar-code option enabled, identification is
correctly achieved through the automatic scan of the bar code for the inserted bottles. The same function can
be performed on demand through "Scan Sector" (near the sector insertion/removal commands).
1.3. Analytical Calibrations and Controls
CALIBRATIONS
The analytical calibrations that can be run by the analyzer are divided as follows: With Factor,
Linear and Non Linear. The selection occurs during the programming of the analytical test
parameters (refer to Chapter C, paragraph 1.3.3. “ Primary Analytical Parameters” ) and can be
executed on user’s request or automatically.
Linear and With factor analyses
“ Factor” : This parameter converts absorbance (ABS)
values detected by the analyzer into final concentration
values. When a theoretical factor is used (i.e. “With
Factor” methodologies), enter in this field the known
factor. The analyzer, when calibrating, calculates and
updates the factor value.
“ Range limit” : In order to verify calibration’s validity, enter
the "Minimum" and "Maximum" range in which the factor
must be included. If an out-of-limit factor is detected, a
message informs the user and the previously stored
value is not modified.
Calibrators or standards used must be placed into
dedicated positions on the samples’ tray. It is possible
to use up to 4 different standard concentrations or
run up to 4 repetitions on a single title (and
position) in the linear analyses.

Figure 6
Programming replicates on a single title
Enter “1” into the “ Number of samples” , then enter the “ N. replicates” (up to 4 max). Select the
actual position (“ Pos.” ) on the tray for the replicated standard and then the concentration
(“ Conc.” ). The values are automatically updated in the “ ABS” boxes during the calibration.
Programming several standards
Enter the number of standards to be used in the “ Number of samples” textbox. Enter the actual
positions (“ Pos.” ) on the tray for each standard and then the
concentrations (“ Conc.” ). The values are automatically
updated in the "ABS" boxes during the calibration.
Calibration parameters
“ Max Var. (%)” (Maximum percentage variation): This
parameter is for verifying percentage variation. It
represents the acceptable difference between the ABS
values calculated for the different calibration points, in
case more calibrators are used or repetitions are
performed on a single title. When an out-of-limit variation
occurs, a message informs the user and the calibration will not
be stored (the previous positive calibration will remain in
memory).
Figure 7 “ Reagent mABS” : It is a read-only field and it is updated every
time the blank reagent is performed. In case “ Dynamic Blank”
is enabled, (refer to Chapter C, paragraph 1.3.3. “ Primary Analytical Parameters” ), then the
reagent ABS value and the variation detected during blank’s reading are displayed.
“ % from last calibration” : It is a percentage check made between current and previous calibration.
It compares the newly determined ABS with already stored data. If the programmed limit is
surpassed, then a message informs the user and the previous positive calibration will remain intact
in memory.

“ Automatic adjust” : It is a password-protected parameter that enables or disables automatic

modification of test results in case of an additional calibration run during patients’ execution.

“ Last Standardization” : This field displays date and time for the last stored positive calibration. By
double-clicking over the date textbox it is possible to display the previous calibration parameters.

“ Save” : This command saves data and then closes the window.

Non Linear analyses: These tests require from 3 to 6 standards. Enter the number of standards to
be used in the “ Number of Samples” field. Enter the actual positions (“ Pos.” ) on the tray for each
standard and then the related concentrations (“ Conc.” ). The values are automatically updated
during calibration into the “ ABS” boxes.

To use standards pre-dilution

function, enable the “ Automatic
Dilution” . It is then possible to
select whether dilution must be
performed with water or
physiological solution (“ Dilution
with solution” ). In the “ Dilution” field enter the required dilution ratio. If automatic dilution is not
required, then appropriate concentration of the corresponding standard must be entered in the each
concentration field.

“ Graph” : This command displays the graph of the stored interpolation curve. In the graphic display
page, data and curve are displayed together and can be printed.

Fig. 8

Normalization procedure for the stored calibration curve

Enable with check “Re-calibrating on single point”, then enter in the “ Calibration point” , the
position number (corresponding to the “Number” field) occupied by the desired calibrator during the
plotting of previous curve. Then enter in the “Sample position”, the position on the tray where it
should be placed. After determination, the analyzer calculates the percentage offset for the current
result from the stored value, then reprocesses and mathematically updates the remaining ABS
values of standards already pertaining to the curve, thus normalizing the whole calibration.
CONTROLS
The controls are divided into “ Known” and “ Unknown” , where it is possible to program three
levels for each one subdivided in tables:
“ Known” : Level 1, 2, 3
“ Unknown” : Level 1, 2, 3

Figure 9 Figure 10

“ Known” : Enter lot name or number, mean value, and min & max limits. Enter tray’s position,
already set to controls in the section “ Setup Analyzer” included in the inner ring of samples’ tray.
“ Unknown” : Enter lot name or number and tray’s positions. Reserved positions are those already
set in the program “ Setup Analyzer” , which are shared with known ones.

RUNNING STANDARDS AND CONTROLS

The functions “ Run Standards” and “ Run Controls” can be accessed from “Tests” main menu or
through the specific icons that allow direct access (Fig. 11 and 12).
The displayed analysis codes pertain to the list generated in the “ Current tray” . To run standards
and controls, select the desired tests and then click on the “ Run” button. To leave program press
" Exit" .

Run Standards Run Controls

Direct access icon Direct access icon

Figure 11 Figure 12
1.4. Entering Patients and Work Lists

Entering Samples (Routine, STAT, Controls and Batch)

Samples can be entered with “Insert Routine/STAT” or with “Insert Batch”. These can be
accessed from “ Patients” main menu or through appropriate direct access icons. Select "Exit" to
leave the program. The represented analyses codes pertain to the list generated in the "Create
current tray".
Entering Patients: The options outlined below are available in this page "Global Insert/View
Patients" (Figure 13). Point the cursor on the desired option and click to confirm. To leave program
press " Exit" .

Direct access icon

Figure 13

“ Re-run” : allows tests re-run (repetitions) on user’s demand.

“ Routine” : Default displays of Patient positions

“ STAT” : Displays STAT (Single Test in Actual Time, i.e. urgent positions) positions.

“ Control” : Displays Control positions.

“ Standard” : Displays Calibrator positions.

“ New Entry” : Displays window for entering data of Routine, STAT and Control samples.

“ Extra Patients” : Displays the list of patients with no assigned position. Patients selected in the
work-list may be moved here (“Options” menu, “Send to extra patients” command) and then back.

" Exit" : To leave program press " Exit" .

Example of entering samples

New Entry Routine:

Figure 14

After the selection of "Routine" followed by confirmation through command "New Entry", the
patients acquisition frame is displayed (Figure 14). The programmed patient can be executed
immediately or saved for later use. The programming fields and the functions are outlined below:
“ Code” :
It is the identification number assigned by the user to the patient. It is possible to assign an already
given code thus creating a clone of the patient. The cloning of a patient's code allows the user to
obtain one report in case different samples are used. If this option is not used, then separate reports
are obtained. It is also possible to create multiple duplicates of the same patient, where the codes
will be automatically assigned and identified by the name “Autobatch”. These will have individual
reports.
“ Surname” , “ Name” :
Enter patient’s personal data.
“ External Dilution Factor” :
By default set to “1”. It allows analysis determination on externally diluted samples. Enter in this field
the external dilution factor ratio used in sample preparation. Final result is multiplied by the inserted
external dilution factor.
“ Group” :
Select the group (Man, Woman, Child) for correct reference with normal values range.
“ Type” :
It is default set to “Serum”. The sample type (Serum or Urines) is selected here. If “Urine” is
selected, then the volume of diuresis (in liters) is requested.
“ Assigned Group” (“ Routine” or “ CTRL Routine” ):
The default setting is “ Routine” . It is used for selecting the category (Patient or Control Serum)
during sample programming. Selecting “ CTRL Routine” the type (“ Known” or “ Unknown” ) and
levels (Level 1, 2, 3) must be specified.
“ Position” :
Displays the assigned position on the sample tray.
“ Test” :
Generates the Analysis List. Select each analysis to be performed on the sample.
“ Profile” :
Select the desired profile among the available. The analyses programmed in this way can be
modified. To add or remove tests, it is necessary to enter in the screen "Select tests" and confirm by
clicking on the textboxes. With “Deselect” it is possible to delete an already selected profile.
“ Save” :
Saves patient’s data and the associated analyses. With this command test execution is delayed.
NOTE:
In the routine programming, it is possible to acquire a greater number of patients than the available
number of positions in samples’ tray. All the patients acquired with no associated position are saved
and displayed in the extra patients list and can be transferred to the main list on user’s demand (refer
to paragraph 1.5. “ Work Lists” ).
“ Run” :
This command immediately starts the execution of the programmed patient. The sample plate
adjusts itself to match the position assigned to the patient, and a blinking red LED indicates the
position for inserting cup or primary tube. If patient code is missing or no analyses have been
selected then this command cannot be activated.

Entering samples in Batch

Direct access icon

Figure 15

Batch Entry: Click test code, then click each desired position (selected positions are highlighted in
red). Finally click on the checkbox by the code to activate the programmed batch. Select the “ Run”
button to perform the patients. Refer to Figure 15.
Work Lists

Figure 16
Work Lists (Figure 16) are used to display the patient codes or to verify the status of the samples in
the tray together with the situation of Routines, STAT, Controls and Calibrators. The Work Lists can
be accessed through the menu "Patients" → "Insert Routine/STAT" or using its direct access icon.
The screen displays the “Current Tray (Routine)” in the center and the “Extra Patients (Routine)”
on the right. During the working phase, the "Re-run" is also shown.
The "Options" menu is available in the "Current Tray" (Routine, STAT, and Controls). It displays
various commands outlined in the following paragraph " 1.5. Running Tests" and the " Chapter E,
paragraph 1.5. Work Lists" .
1.5. Running Tests
Once the data has been entered, insert the samples into the tray (Figure 17) and then place the
analyzer into the tray (Figure 18).

Figure 17 Figure 18

“ Options” :
The “Options” menu is available in the "Current Tray" (Routine, STAT and Controls). It displays the
following commands:

“ Send to extra patients” :

The selected patients are removed from current samples tray list for
placement on "Extra Patients List". Selection can be done by checking the
appropriate boxes.
“ Print” :
Prints the partial (for selected items) or total samples list.
“ Select All” :
Automatically selects the whole list.
“ Deselect All” :
Automatically deselects the whole list, confirmation required.
“ Run” : Work start command. If single patients or the whole list are selected, a message asks if the
samples have been inserted. If the answer is affirmative, the analyzer automatically starts
processing. In case of a negative answer, a guided procedure will assist the user to insert the
samples. The selection of the sample to be inserted is performed by confirming with cursor on the
check box. Use “Select All” to select the whole list and “Deselect All” to deselect it but in this case
confirmation is required. After the insertion of all the samples, activate "Run"
“ Delete” : Removes selected or all the patients. Confirmation is required.
1.6. DISPLAYING AND PRINTING RESULTS
Displaying Patients Results
The representation of the test r esults can be accessed throug h the specif ic
icon (shown on the right) f or the two available options: “ Vi ew r es u l t s f o r
s am p l e” (results will be displayed f or patient) and “ Vi ew r es u l t s f o r t es t ”
(results will be displayed f or test).

Figure 19
The "Patient’s" data display page is shown in Figure 19. It can be accessed through the
specific icon (shown on the right). When no data is present this page is empty. It is a brief
representation of data and allows visualization of results of patient in execution as the
tasks for the single patients are completed. Once the results are archived, the information present in
this page will no longer be available.
Test results with flags are highlighted in red.
The following information is displayed for each sample:

a) Sample Position (#XX) Progressive number from 01 to 52 for Routine and STAT.
Progressive number from 01 to 26 for STD and CTRL.
b) Sample Code For Patients (Routine and STAT) it is assigned at check-in.
For STD and Batch it is automatically assigned.
It is automatically assigned for CTRL, but can be assigned by the user
during input. The relevant group level is also indicated (see Chapter F,
paragraph 1. “ Quality Controls” ).
c) Surname, Name Patient’s personal data.

d) Sample Type The relationship of Sample to one of the groups: Routine, STAT, CTRL
or STD is indicated between brackets.

e) Results Tests’ results for a given patient are displayed indicating extended
name of the analysis, test methodology, normal values range and any
eventual warning flags (see Chapter G, paragraph 1.5 " Flags List" ).
For automatic repetitions, the values for the first and second
determination are shown.

NOTE:
The information regarding calibrations such as computed factor values or any eventual errors that occurred
during execution (standardization), are shown in the data display page.

The following commands are available in the data display page:

“ Print” : Print command. If enabled, it prints the entire contents of the data display page.

“ Sort” : Data sorting command. This function is enabled only at the end of working session. The
real-time data are displayed in test execution order. The "Sort" command allows rearranging of data
by test sequence order.

“ Adjust” : Data re-reprocessing command. This function is enabled only at the end of working
sessions. After confirming the command and selection of the desired analysis, two data re-
processing modes are available. The first mode allows a positive or negative percentage correction
of increment or decreasing, and the second mode uses the latest valid calibration This function is
password protected (see Chapter C paragraph 1.5.).

“ Archive Data” : This command saves data into the patients archive.

“ Delete results” : This command deletes data. It is password protected.

“ Exit” : Exits from data display page.

RESUL TS PER TEST

Figure 20
After the termination of programmed task, the results can be viewed per " Test" . The test Results
display page is shown in Figure 20. Test results with flags are highlighted in red.
The following information is displayed for each single test:
a) Sample Position (#XX) Progressive Number from 01 to 52 for Routine and STAT.
Progressive Number from 01 to 26 for STD and CTRL.
b) Sample code For patients (Routine and STAT) it is assigned at input.
It is automatically assigned to STD and Batch.
It is automatically assigned to CTRLs, but it can be given by the
operator during input. The group pertinence is indicated. (see
Chapter F, paragraph 1. “ Quality Controls” ).
c) Sample Type The relationship of Sample to one of the groups: Routine,
STAT, CTRL or STD is indicated between brackets.
d) Results Tests’ results with any eventual flags.
The following commands are available in the results display page:

“ Print” : It provides hard copy of the entire contents of the data display page.

“ Exit” : Exits from data display page.

DISPLAYING REAL-TIME DATA

Figure 21
The Figure 21 shows the data display page for "Real Time". This page can be accessed through the
specific icon. When no data is present this page is empty. It is a brief representation of data and
allows real time visualization of results of tests in execution as the single tests are completed. Once
the results are archived, the information present in this page will no longer be available. Test results
with flags are highlighted in red.
The following information is displayed for each single test:
a) Sample Position (#XX) Progressive Number from 01 to 52 for Routine and STAT.
Progressive Number from 01 to 26 for STD and CTRL.
b) Sample code For patients (Routine and STAT) it is assigned at input.
It is automatically assigned to STD and Batch.
It is automatically assigned to CTRLs, but it can be given by the
operator during input. The group pertinence is indicated. (see
Chapter F, paragraph 1. “ Quality Controls” ).
c) Surname, Name Patient’s personal data.
d) Sample Type The relationship of Sample to one of the groups: Routine,
STAT, CTRL or STD is indicated between brackets.
e) Results Tests’ results for a given patient are displayed indicating
extended name of the analysis, test methodology, normal
values range and any eventual warning flags (see Chapter G,
paragraph 1.5 " Flags List" ). For automatic repetitions, the
values for the first and second determination are shown.
The following commands are available in the "Real Time" data display page:

“ Print” : It provides hard copy of the entire contents of the "Real Time" data display page.

“ Exit” : Exits from "Real Time" data display page.

1.7. TURNING OFF THE ANALYZER

To turn off the instrument, the " SHUT DOWN" procedure must be observed. In this way the
instrument is turned off (not completely), except for the reagent refrigerator. The shut down
procedure proposes the wash of the cuvettes as well as the ISE Module with appropriate washing
solutions before turning off. The analyzer indicates the position where the detergent should be
inserted for the cuvettes washing (see also Chapter. C, paragraph 1.1.). As regards the ISE
Module, the two dedicated solutions must be placed in the lodging for the ISE reagents (see
Chapter L).

There are two additional modes for interrupting analyzer operation:

1) “ SLEEP-MODE”
This mode can be manually activated, or it starts automatically when the instrument is left inactive
for more than 30 minutes. The Sleep-Mode automatically performs the wash and fill up of the
cuvettes with bi-distilled water and remains idle (waiting for user’s commands for immediate
operation).

2) “ LOG-OFF”
The "Log-Off" mode represents a partial turning off of the analyzer. It disables some devices:
Halogen Lamp of the photometer, cuvettes thermostat and drive motors. This mode is used for
energy saving.
The Log-Off mode is utilized for programming automatic turning on at a desired date and time. The
instrument will remain in a stand-by condition and it will automatically turn on 30 minutes before the
programmed time. The turning on in anticipation (30 minutes before the programmed time) allows
the analyzer to reach steady state thus allowing immediate operation at the programmed time.

CA UTION!
a) Do not ever stop the analyzer by turning off the main switch prior to performing
the correct " SHUT DOWN" procedure.
b) Improper shutdown may cause loss of data and programs and will necessitate
reinstallation of the operating software.
 OPERATOR MANUAL
BT3000 PLUS

SECTION II: ADDITIONAL INFORMATION

CHAPTER 2
2. WARRANTY CONDITIONS Page: 2

Biot ecnica Inst rument s S.p.A.

2. WARRANTY CONDITIONS

• Biot ecnica Inst rument s S.p. A., aft er having accurat ely t est ed t his analyzer,
guarant ees t he inst rument for 1 (one) year st art ing from invoice.
• The warrant y includes t he repairing and t he replacement f or free of t he f ault y
part s due t o wrong manufact uring. Warrant y is not ext ended t o t he normally
consumable part s of t he syst em.
• The warrant y is not valid in case of improper use, negligence, improper or lack
of maint enance and cleaning, t ampering or repairing by t hird part ies not
aut horized by Biot ecnica Inst rument s S.p.A. and in any case when t he cause
cannot be st at ed as original manufact uring fault .
• The cost s of shipment and t ransport t o Biot ecnica Inst rument s S.p.A. for repair
or subst it ut ion, and t he risks deriving from t his is t he responsibilit y of t he
buyer, including all t he cost s of onsit e t echnical service at client 's locat ion
(t ransport , board and lodging) as well.
• If t he st at ed def ect s will result t o be out of warrant y limit s, t he buyer will pay
repair or replacement cost s.
• Biot ecnica Inst rument s S.p.A. is not responsible f or any unforeseen t echnical
problem t hat might occur. If t he request ed t echnical assist ance is out side t he
t erms of warrant y a charge will me made t o t he cust omer as per current rat es
in force.
• Biot ecnica Inst rument s S.p.A. is an int ernat ionally known for it s high qualit y
st andards in product ion. Biot ecnica Inst rument s S.p.A. is t hus responsible for
providing t o t he cust omer clear and effect ive informat ion f or use of it 's
product s, including all t he precaut ions and warnings for a secure and risk-free
use.
• Service personnel must also refer t o t he warnings and caut ions not ices in t his
manual. It is t he dut y of t he service engineer of Biot ecnica t o inst ruct his
service personnel t o t ake all necessary precaut ions during repair and handling of
product s.
• Biot ecnica Inst rument s S.p.A. is not responsible for any damage t hat may be
caused direct ly or indirect ly t o persons or t hings due t o a lack of observance of
all t he warnings and caut ions out lined in t he user's manual, and concerning t he
warnings and caut ions during t he dif ferent working phases of t he inst rument
(see chap. M). Direct , indirect , incident al, special, moral damages as well as
ot her damages of any t ype (including, wit h no limit at ion, t hose deriving f rom
profit ’ s loss, business int errupt ion or inf ormat ion loss) cannot be ascribed t o
Biot ecnica Inst rument s S.p.A. even in t he case in which t he possibilit y of t he
event had been explicit ly st at ed.
Biot ecnica Inst rument s S.p.A.
Via Licenza, 18
00156 Rome – ITALY
Tel. +39-06-4112316
Fax +39-06-4103079
E-mai l: bt @biot ecni ca.i t
NOTES FROM THE MANUFACTURER
¾ The Biot ecnica Inst rument s S. p.A. reserves t he right t o revise t his manual
wit hout not ice, f or any reason. This includes but is not limit ed t o, ut ilizat ion of
advance in t he st at e-of-t he-art and changes t hereof. Product enhancement
result ing from our cont inuing qualit y improvement ef fort may necessit at e
changes in specificat ions wit hout not ice. This fact doesn’ t oblige t he company
t o inform it s act ual cust omers because t he informat ion included in t he present
manual ref ers t o st at e of t he product when shipped, t hus no warrant y about
not ificat ion of f ut ure changes is given.
¾ The informat ion cont ained in t his manual is propriet ary wit h "Biot ecnica
Inst rument s S.p.A.". Reproduct ion of any part or whole may only be performed
wit h writ t en permission f rom "Biot ecnica Inst rument s S.p.A.".
 Page 1 of 1

Mod.05- 35a- ing Rev . 0

Part s / I nst rum ent s Ret urn Aut horizat ion
DATE: ______/______/____

From:
To: Technical Assistance – Export Manager
Client information
Instrument model: Serial number:

Defective part
Part description:

Code: Serial number:

Bar-code number: Quantity:
Under warranty: Yes No Order number: Date:
Description of the problem:

Request for:
Repair Exchange Quotation Urgent

Name: Signature:

Biotecnica Instruments response

Return authorization number: / 2004 Date:

Approved: Yes No
Repair Exchange Destroy Quotation:
Note:

Approved by: Technical Assistance Dept. Signature:

Quality Control Manager Supervising Signature:
NOTE: No parts or instruments will be accepted for repair or replacement without a Return Authorization number
which can be obtained from Biotecnica Instruments S.p.A. Fax this Return Authorization form to +39 06 410 3079
to the attention of Technical Assistance/Export Manager, who will then evaluate and issue a Return Authorization
number.

WARRANTY EXCTRACT: Biotecnica Instruments S.p.A. warrants its instruments to be free from defective parts
and workmanship for a period of one (1) year from the date of purchase. Liability under this warranty is expressly
limited to repair or replacement of defective parts at the option of Biotecnica Instruments S.p.A. This warranty
does not cover the results of misuse, accident or abuse of any parts of its instruments which have been repaired,
tampered with or altered by anyone other than personnel authorized by Biotecnica Instruments S.p.A. This
warranty does not apply to fluid handling devices, consumables or reagents.
Products returned to Biotecnica Instruments S.p.A. for repair or replacement shall be sent with transportation
prepaid.
If found not to be defective under the terms of warranty, a charge will be made for repair or replacement and
 OPERATOR MANUAL
BT3000 PLUS

SECTION II: ADDITIONAL INFORMATION

CHAPTER 3
3. ORDERING INFORMATION Page: 2
3.1. GENERAL TERMS AND CONDITIONS FOR SALE Page 2
3.2. Consumables for BT3000 PLUS Page: 3
3.3. ISE Module Consumables Page: 4

Biotecnica Instruments S.p.A.

Via Licenza, 18
00156 Rome – ITALY
3. ORDERING INFORMATION
Please contact Biotecnica Instruments S.p.A. for any configuration or special requirement
not covered in this manual. For technical or ordering assistance start with our convenient
ordering check list located in the ensuing paragraphs 3.2. and 3.3. For further assistance,
don't hesitate to call the Biotecnica Instruments S.p.A. or your local sales/representative
office.
To obtain accessories/spare parts, address order or enquiry to your Biotecnica Instruments
S.p.A. sales/service representative or to Biotecnica Instruments S.p.A. and supply the
following Informations:
a) Instrument Model and Serial Number
b) Quantity of parts desired
c) Part Number
d) Description
Biotecnica Instruments S.p.A.
Via Licenza,18
00155 - Rome (ITALY)
Phone: +39 06 411 2316 Fax: +39 06 410 3079 E-mail: bt@[Link]
NOTE:
DUE TO IMPROVEMENTS IN DESIGN AND/OR SPECIFICATIONS, SOME PRODUCTS MAY DIFFER
SLIGHTLY FROM THE PREVIOUS DESCRIPTION.

3.1. GENERAL TERMS AND CONDITIONS FOR SALE

ORDERS: All telephone or written orders placed by the customer are considered a binding
contract created with the Company, when a written order acceptance has been sent by the
Company or the ordered goods have been shipped. For orders with a value over Euro
150,00 each, the goods including the packing cases are shipped carriage paid. All prices
listed exclude VAT and all similar taxes and the purchaser will be liable for such taxes if
applicable.
SHIPMENTS: In accordance with the general provisions of law, the goods are shipped at
the customer's risk even where shipped carriage free.
The goods with cold storage temperature between 2 - 8° are shipped at controlled
temperature.
CLAIMS: Any claims must be made within 10 days from the receipt of goods.
PAYMENT TERMS: The terms of payment indicated on the invoice are valid. In the event
of overdue account, default interest at the rate of 2% above the official discount rate will be
added to the outstanding account.
JURISDICTION: For any judicial contest, legal venue for both parties is Rome (Italy).

For further info, see Biotecnica site at [Link]

3.2. CONSUMABLES FOR BT3000 PLUS

PRODUCT PART NO. SIZE

Surfactant Wash Concentrate 392 2x50 ml
Cuvettes washing solution 393 1 liter
Fuse 0.5AT, 250 Volt (for Vac Pump P/N 06-05161-01) 330.6338 1
Fuse 2AT, 250 Volt (for Vac Pump P/N 662.0788/C/D/E/F) 330.6340 1
Fuse 8AT, 250 Volt (for Analyzer) 330.6342B 1
Power Cord (for analyzer) 330.6391 1
Power Cord (for peripheral devices) 330.6400 1
Peristaltic Pump Cartridge 330.9072 1
Halogen Lamp 12V/35W for Photometer 330.9321 1
Tubular Filter for H2O container 330.9614 1
Distilled Water container 5 lt Cubitainer 660.4002 1
Cleaning Tool for Arm Needle 662.0629A 1
Hydrophobic Filter Assy (for Vac Pump P/N 662.0788/C/D/E/F) 662.0807 1
Waste Container 10 lt Cubitainer 662.1010 1
Sampling Needle 662.1011 1
Bimonthly Maintenance Kit (for ISE Module) 662.1016 1
Six-Monthly Maintenance Kit (tubing etc.) 11-05219-01 1
(for analyzers with vacuum pump P/N 06-05161-01,02,03)
Six-Monthly Maintenance Kit (tubing etc.) 662.1002 Refer to "Section I, Chapter
K, Vacuum Pump System "
(for analyzers with vacuum pump P/N 662.0788/C/D/E/F)
Annual Maintenance Kit (Tubing etc.) 11-05220-01 1
(for analyzers with vacuum pump P/N 06-05161-01,02,03)
Annual Maintenance Kit (tubing etc.) 662.1009 Refer to "Section I, Chapter
K, Vacuum Pump System"
(for analyzers with vacuum pump P/N 662.0788/C/D/E/F)
Serum Capsule 2 ml 667.1040 1 (min. 1000)
Reagent Bottle 80 ml 667.1072 1
Reagent Bottle 50 ml 667.1073 1
Reagent Bottle 20 ml 667.1074 1
Reagent Bottle 10 ml 667.1076 1
3.3. ISE MODULE CONSUMABLES

PRODUCT PART NO. SIZE

I.S.E. Low Calibrator 943 2x20 ml

I.S.E. High Calibrator 944 2x20 ml

I.S.E. Starter Kit #BT3000 PLUS (600 Tests) 947 1

(Consists of: 943, 944, 947A, 947B, 947C, 947D)

I.S.E. Buffer #BT3000 Plus (concentrated) 947A 3x10 ml

I.S.E. Reference #BT3000 Plus (concentrated) 947B 3x10 ml

I.S.E. Washing Solution 947C 3x10 ml

I.S.E. Enzymatic Solution 947D 3x10 ml

By-Pass Electrode 662.0709 1

Reference Electrode 662.0710 1

Sodium Electrode (Na) 662.0711 1

Potassium Electrode (K) 662.0712 1

Chloride Electrode (Cl) 662.0713 1

CO2 Electrode 662.0716 1

Cleaning tool for Chloride Electrode 03254 1

 OPERATOR MANUAL
BT3000 PLUS

SECTION II: ADDITIONAL INFORMATION

CHAPTER 4
4. Software
4.1. Serial Communication:
Page: 2
BT3000 PLUS <-> Host Computer
4.2. Variable communication protocol Page: 6
4.2.1 Serial communication test programs Page: 17

Biotecnica Instruments S.p.A.

Via Licenza, 18
4. SOFTWARE
4.1. SERIAL COMMUNICATION: BT3000 PLUS <-> HOST COMPUTER

General
The analyzer BT 3000 PLUS allows bi-directional communication through RS 232C serial
connection with any host computer.
The particular feature of the dialog is that it is always the host computer, which initiates the
communication for either transmitting patient list or for receiving the results.
To initiate any communication the host computer will have to send to analyzer the character
STX (0x02) and expect the character ACK (0x06) as a response. At this point the host
computer will send data to the analyzer and terminate the communication by sending the
character EOT (0x04).
It is important to remember that any communication is followed by a response from the
analyzer.
It must be noted that if the parameter to be transmitted is shorter in length than the length
requirement of the communication protocol than a space must be added before or after. For
example the analysis have length 4, therefore to send a code GLI one must add a space
before or after to reach the length of 4 characters.

Patient transmission
► Start communication with sequence STX<->ACK.................
► Send patient code.................................................................. (15 characters)
► Send list type for patient insertion......................................... ("T" for Routine or "R" for STAT)
► Send type of serum............................................................... ("S" for Serum or "U" for Urine)
► Send if the patient is a clone................................................. ("Y" for Yes or "N" for No)
► Transmit position of cup........................................................ ("00" unknown)
► Send number of tests to be executed.................................... (from "01" to "99")
► Send codes of tests to be performed..................................... (4 characters)
► Send Check-Sum................................................................... (3 characters)
► Send end transmission character EOT..................................
► Wait for response from the analyzer...................................... (2 characters)

If the communication is successful then the analyzer responds with character "Y" followed
by a byte, which identifies the position where patient has been inserted. In case the
communication was unsuccessful, then the analyzer responds with "N" followed by a byte
identifying the type of error. The possible errors generated by the analyzer in response to
the invalid insertion of patient are as follows:

0x01..................... Check-Sum Error

0x02..................... Unknown Command
0x03..................... Routine/STAT field Error
0x04..................... Serum/Urine field Error
0x05..................... Clone Yes/No field Error
0x06..................... Cup position Error
0x07..................... Number of Analysis field Error
 0x08..................... Wrong Number of Test
0x09..................... Position already in execution
0x0A.................... Cloning impossible
0x0B.................... Code duplicated
0x0C.................... One or more analysis not present in the analyzer
0x0D.................... One or more analysis not present in the current plate
0x0E.................... Too many analysis for the patient

For example to send a patient with code 000000000000001, serum type and with analysis
GLI, BUN and COL onto the STATS list, then one must send the following sequence of
characters (excluding initial sequence STX<->ACK):

000000000000001RSN0003GLI BUN COL 134<EOT>

Where:

000000000000001............. Patient code

R........................................ Identifies STATS list
S........................................ Identifies the type of patient (in this case: Serum)
N........................................ Identifies that the patient is not a clone
00....................................... Unknown position (the analyzer will insert the patient in a
convenient position)
03....................................... identifies the number of test to be executed.
GLI, BUN, COL................. Test codes (observe the space after each code to reach the 4
characters limit)
134..................................... Identifies the Check-Sum
<EOT>............................... This character ends communication

Results reception
There are three commands for receiving reports from the analyzer:
R.......... Reception of next available report
L.......... Reception of the last report sent (in case of reception problems)
A.......... Reception of the first available report (in case one desires to receive again all
the reports)
The commands R, L, and A require standard communication or the procedure STX<->ACK
and the character EOT to end communication.
As a response to one of these three commands the analyzer sends the requested report (if
available) or the character NAK (0x15) if there is no report to be sent. It must be borne in
mind that after a run test the reports are not immediately available for transmission as these
need validation. To do this, go to Utility menu, RS232 and enable the option "Accept result
to be sent". This operation must always be performed after each run test or groups of run
test.
There is also an additional option for performing validation operation automatically. Go to
Setup of the analyzer (Menu Utility, Setup Analyzer), go to the Serial (fourth from the left)
and enable the option "All results must be sent automatically (without validate)" at the
bottom of the page.
In case of positive response to the request for a report the analyzer transmits:

Patient code........................ 15 characters

List type............................... "T" for Routine or "R" for STATS
Sample type........................ "S" for Serum or "U" for Urine
Number of reports.............. 3 characters

For each report:

Analysis code..................... 4 characters
Result.................................. 7 characters
Check-Sum......................... 3 characters
<EOT>

The following is an example of eventual response to the data sent in "Sending a patient to
BT3000 PLUS":

000000000000001RS003GLI 000.000BUN 0010.10COL 00100.0107<EOT>

Where:
000000000000001........ Patient code
R.................................... Identifies STATS list
S.................................... Identifies the type of patient (in this case: Serum)
003................................ Identifies numbers of reports
GLI................................ First test code
000.000......................... GLI test result
BUN.............................. Second test code
0010.10......................... BUN test result
COL............................... Third test code
00100.0......................... COL test result
107................................ Identifies the Check-Sum
<EOT>.......................... This character ends communication

Calculation of Check-Sum:
This procedure calculates a Control code in accordance with the transmitted or received
data. An algebraic sum of ASCII values of all the sent characters is executed. For example
the character "A" has ASCII value 65 - 0x41.
Consequently the module 256 of the found value is executed (balance of dividing the value
by 256). This is the Check-Sum to be sent.
Wiring Diagram of Interface Cable

BT3000 PLUS

Figure 1

BT3000 PLUS

Figure 2
4.2. VARIABLE COMMUNICATION PROTOCOL

Introduction
The variable serial protocol has been designed to provide the user with possibility to
personalize the transmitted and received data from the analyzer.

The user can transmit or receive in addition to preset data (patient code, analysis code,
results etc.), also the simple text strings and/or characters in order to meet the personal
requirements.

Not only the user can decide to send or receive numerical information (for example number
of tests) not as single byte but as a preset numerical string or vice versa.

For example the user can decide to receive something like:

"Initiate analysis data"

<Analysis data true and typical>
"End analysis data"

Where the phrases "Initiate analysis data" and "End analysis data" do not refer to any
preset data by the analyzer but serve only for monitoring communication process (can be
useful for inserting specific markers on those programs which obtain information from text
files).

It is obvious that the protocol of initiation and end of communication, the commands for the
request of report, and the analyzer responses in case of error or success remain identical to
the usual preset serial communication.

NOTE:

a) If a check-sum is omitted in a communication then the analyzer will not control it.
b) The following numbers have been used to represent the error codes relevant to
sending a patient to the analyzer as regards the parameters not part of the
standard serial communication:

Error Code Description

1 Number of invalid analysis
2 Invalid Data (not through variables)
3 Invalid Data (through variables)
4 An analysis variable is outside the SET BEGIN/END
relative to the analysis
Notes regarding Scripts
A script is a text document. Each one of the single commands must each reside in a
different line and be complete. In other words a single command cannot be divided into
more lines.

Stringn ‘Name’|$10 -> Valid line

Stringn ‘Name’|$10 char ‘A’ -> Invalid line

Stringn ‘Name’ -> Invalid Command

|$10

An editor for writing, modifications, saving and compiling of one or more scripts is
accessible inside the program (setup function). In any case it is possible to write a script
with any text editor (DOS or Windows) like Notepad of Windows or the EDITOR of the DOS.
It is not possible to import documents written with UNIX as the characters used for going to
the next line are different from the ones used by the DOS or Windows.

CAUTION!
If one wants to use the script stored in a removable disk (for example floppy disk)
then it will be necessary to copy it on the hard disk.

TYPE OF DATA

Character: Identifies a single character, can pass as printable character (enclosed between single
apostrophes), as decimal ASCII value (followed by symbol $) or else hexadecimal ASCII
value (followed by 0x).
If for example we want to identify the character A (decimal value 65 or
hexadecimal value 41) then we can write 'A', $65 or 0x41.
String: Identifies a sequence of printable characters enclosed in single apostrophes, for example:
'this is a string'.

Comment: Identifies a portion of test (preceded by a character ; which will not be compiled but will
serve as note only for the programmer.

Variables: These are particular sequence of characters preceded by the symbol #, which will be
used by the program for storing internal information (patient code, analysis name and
etc.), refer to "TABLE 1 - TRANSMISSION/RECEPTION".
There are also variables for direct uses, which allow for identification of
any character below ASCII 32 (space) to facilitate the writing of the script
(for example, one can use the variable #EOT to identify the character $4),
see "TABLE 2 - INTERNAL VARIABLES".
SCRIPT FUNCTIONS

String: Identifies a string of variable length ending with a particular character.

Syntax:
String <string>I<Terminator>

Where
<String> Transmit/receive string
<Terminator> End character

Note:
It is not possible to use the variables like parameter <Terminator>

Example:
String ‘Hello Word’|$0
String ‘My String’|’@’
String #Variable1|0x10

Stringn: Identifies a string of fixed length

Syntax:
Stringn <String>|<Length>

Where
<String> Transmit/receive string
<Length> String length

Note:
If the length of the text strings is less than the data length then a series of spaces will
be added on the right to reach the data preset length. In case the text string is longer
than the data length then the string end will be cut off to match the data length.

If the length of the numerical values is less than the data length then a series of
characters '0' will be added to the left to reach the preset data dimension. In case the
length of the numerical values string is longer than the data length then the string will
be truncated to match the data length.

It is not possible to use variables as parameter <Length>.

Example:
Stringn ‘Hello Word’|$40
Stringn #Variable1|0x10
Char: Identifies a single character (or single byte)

Syntax:
Char <Character>

Example:
Char ‘H’
Char $20
Char 0x10
Char #STX

Set: Identifies the beginning and the end of the group of repetitive commands

Syntax

Set Begin<Name of group>

Begin repetitive group

Set End<Name of group>

End repetitive group

Note:
Actually the ANALYSESDATA is the unique SET present, which identifies the
analysis in transmission/reception.
Only one command SET BEGIN and one command SET END can be present in a
script.
A script must always contain the command SET.
The variable PATIENTNUMBERTEST must be present before the command SET.
COMPILATION ERROR

One or more errors due to incorrect script writing or the system error may show up during
compilation of a script. The compiler shows the error code, the description of error, and the
line where it has been detected.
The following table shows the error codes, description, and the possible causes:
Error Code Description Possible Causes
An invalid command has been inserted in the
1 Unknown command
commands of script.
A string as first parameter for String or Stringn
2 A string request
command has not been inserted.
A string like parameter <lunghezza> of command
3 A number request
Stringn has been inserted.
04 Invalid number format Inserted invalid decimal or hexadecimal number.
a) Inserted more than two parameters for
command String or Stringn.
5 Excessive data
b) Inserted more than one parameter for the
command Char or Set.
6 Invalid data A string for command Char has been inserted.
7 String Terminator Request The end (') character of a string not found.
a) Inserted less than two parameters for
command String or Stringn.
8 Too little data
b) No parameter inserted for command Char or
Set.
The string length for Stringn command is less than 0
9 Invalid String Length
or more than 128.
a) An empty string inserted for the command
10 Empty string String or Stringn.
b) Inserted a character identified as "
a) Tried to transfer an invalid variable in the list
of internal variables.
11 Unknown variable
b) Tried to use a transmission variable in the
script of reception or vice versa.
12 Damaged file Hard disk error. Contact Sales/Service.
Internal error. Probably damaged program. Reinstall
13 Unknown file the program. If the problem persists contact
sales/service.
a) The text SET BEGIN or SET END not written.
Incorrect identifier in the b) A different value from ANALYSEDATA
14
SET command. transferred as <Group name> for the SET
command.
15 Damaged exit file Hard disk error. Contact sales/service.
16 SET command not closed The SET END not inserted in the script.
17 Too many SET commands More than one SET BEGIN command inserted.
18 SET command not found The SET BEGIN command not found in the script.
Incorrect variable for SET A different value from ANALYSEDATA transferred
19
command as <Group name> for the SET command.
Variable not found before The highlighted variable required in the script before
20
the SET command the SET BEGIN command.
The variable must be String The highlighted variable must be String type, not
21
type Char
 TABEL 1 – TRANSMISSION

The following variables are used for the transmission of a report from analyzer to the host
computer:
Variable Usage Type of valid data
PATIENTCODE Patient Code String
PATIENTNAME Patient Name String
PATIENTSURNAME Patient Surname String
(1)
PATIENTGROUP Group String Character
(2)
PATIENTLISTTYPE List String Character
(3)
PATIENTTYPE Method Type String Character
PATIENTNOTE Descriptive Note String
PATIENTNUMBERTEST Number of Results String Character
CHECKSUM Check-Sum String Character
ANALYSESCODE Analysis Code String
ANALYSENAME Analysis name String
(4)
ANALYSESTYPE Analysis Type String Character
ANALYSESCONCENTRATION1 1st Concentration String
ANALYSESCONCENTRATION2 2nd Concentration String
ANALYSESFLAGS1 Flag 1st Result String
ANALYSESFLAGS2 Flag 2nd Result String
ANALYSESMINVALUE Minimum Value String
ANALYSESMAXVALUE Maximum Value String
ANALYSESUM1 1st Unit of Measurement String
ANALYSESUM2 2nd unit of measurement String
ANALYSESUMFACTOR Unit Factor String
(5)
ANALYSES2RESULT Does the 2nd result exists? String Character
(3)
ANALYSESSERUMTYPE Method Type String Character
ANALYSESURINE24H Urine in 24/h String
(1)
Identifies Male, Female or Child (Select one of these):
‘M’ : Male
‘F’ : Female
‘C’ : Child
(2)
Identifies Routine or STAT (Select one of these):
‘R’ : Routine
‘S’ : STAT
Transmitting patient from archive will always have identifier of Routine.
(3)
Identifies Serum or Urine (Select one of these):
‘S’ : Serum
‘U’ : Urine
(4)
Identifies Clinical Chemistry, ISE Module or Relation Analysis (Select one of these):
‘C’ : Clinical Chemistry
‘I’ : ISE Module
‘R’ : Relation Analysis
(5)
Identifies if the 2nd result exists or not (Select one of these):
‘Y’ : 2nd result exists
‘N’ : 2nd result does not exist

• If only the final result is desired then always refer to variables pertaining to 2nd result.
• In case of the absence of 2nd result then its variables will have the same values of the 1st result.
 TABLE 1 – RECEPTION

The following variables are used for reception of a patient by the analyzer:
Variable Usage Type of valid data
PATIENTCODE Patient Code String
PATIENTNAME Patient Name String
PATIENTSURNAME Patient Surname String
(1)
PATIENTLISTTYPE List String Character
(2)
PATIENTGROUP Group String Character
(3)
PATIENTTYPE Method Type String Character
PATIENTURINE24H Urine in 24/h String
PATIENTNOTE Descriptive Note String
(4)
PATIENTISCONTROL If the patient is a control String Character
(5)
PATIENTCONTROLKNOK If it is a known control String Character
(6)
PATIENTCONTROLLEVEL Control Level String Character
(7)
PATIENTCLONE If it is a clone String Character
PATIENTCUPPOSITION Vial (Cup) position String Character
PATIENTNUMBERTEST Number of test String Character
CHECKSUM Check-Sum String Character
ANALYSESCODE Analysis Code String
(1)
Identifies Routine or STAT (Select only one of these):
$0 : Routine
$1 : STAT
‘0’ : Routine
‘1’ : STAT
‘R’ : Routine
‘S’ : STAT
‘ROUTINE’ : Routine
‘STAT’ : STAT
(2)
Identifies Male, Female or Child (Select only one of these):
$0 : Male
$1 : Female
$2 : Child
‘0’ : Male
‘1’ : Female
‘2’ : Child
‘M’ : Male
‘F’ : Female
‘C’ : Child
‘MAN’ : Male
‘FEMALE’ : Female
‘CHILD’ : Child
(3)
Identifies Serum or Urine (Select only one of these):
$0 : SERUM
$1 : URINE
‘0’ : SERUM
‘1’ : URINE
‘S’ : SERUM
‘U’ : URINE
‘SERUM’ : SERUM
‘URINE’ : URINE
(4)
Identifies a Control or a Sample (Select only one of these):

$0 : Sample
$1 : Control
‘0’ : Sample
‘1’ : Control
‘N’ : Sample
‘Y’ : Control
‘S’ : Sample
‘C’ : Control
‘NO’ : Sample
‘YES’ : Control
‘SAMPLE’ : Sample
‘CONTROL’ : Control
(5)
Identifies a Known or Unknown Control (Select only one of these):

$0 : Unknown
$1 : Known
‘0’ : Unknown
‘1’ : Known
‘N’ : Unknown
‘Y’ : Known
‘U’ : Unknown
‘K’ : Known
‘NO’ : Unknown
‘YES’ : Known
‘UNKNOW’ : Unknown
‘KNOW’ : Known
(6)
Identifies Control Level (Select only one of these):
$1 : Level 1
$2 : Level 2
$3 : Level 3
‘1’ : Level 1
‘2’ : Level 2
‘3’ : Level 3
‘L’ : Level 1
‘N’ : Level 2
‘A’ : Level 3
‘LOW’ : Level 1
‘NORMAL’ : Level 2
‘ABNORMAL’ : Level 3
(7)
Identifies if it is a Clone (Select only one of these):
$0 : Normal
$1 : Clone
‘0’ : Normal
‘1’ : Clone
‘N’ : Normal
‘Y’ : Clone
‘NOCLONE’ : Normal
‘CLONE’ : Clone
 TABEL 2 – INTERNAL VARIABLES

Variables Decimal Hexadecimal

NUL $00 0x01
SOH $01 0x02
STX $02 0x03
ETX $03 0x04
EOT $04 0x05
ENQ $05 0x06
ACK $06 0x07
BEL $07 0x08
BS $08 0x09
TAB $09 0x0A
LF $10 0x0B
VF $11 0x0C
FF $12 0x0D
CR $13 0x0E
SO $14 0x0F
SI $15 0x10
DLE $16 0x12
DC1 $17 0x13
DC2 $18 0x14
DC3 $19 0x15
DC4 $20 0x16
NAK $21 0x17
SYN $22 0x18
ETB $23 0x19
CAN $24 0x1A
EM $25 0x1B
SUB $26 0x1C
ESC $27 0x1D
FS $28 0x1E
GS $29 0x1F
RS $30 0x20
US $31 0x21
 SCRIPT EXAMPLES

The examples outlined here are the transformation in script of the standard routine of the
patient reception by the analyzer.

Stringn #PatientCode|$15
Char #PatientListType
Char #PatientType
Char #PatientClone
Stringn #PatientCupPosition|$2
Stringn #PatientNumberTest|$2

Set #BeginAnalysesData
Stringn #AnalysesCode|$4
Set #EndAnalysesData

Stringn #CheckSum|$3

The following are the details of the above Scripts:

Stringn #PatientCode|$15
Patient Code of fixed length equal to 15 characters

Char #PatientListType
Type of list (Routine/STAT) as single character

Char #PatientType
Serum type (Serum/Urine) as single character

Char #PatientClone
Identifies if the patient is or is not a clone (single character)

Stringn #PatientCupPosition|$2
Position of serum cup (string of fixed length equal to 2 characters)

Stringn #PatientNumberTest|$2
Number of tests to be executed (string of fixed length equal to 2 characters)

Set #BeginAnalysesData
Beginning of analysis codes

Stringn #AnalysesCode|$4
An analysis code of fixed length equal to 4 characters. It must be entered for each type of test
as per qty indicated in the #PatientNumberTest.

Set #EndAnalysesData
End of analysis codes

Stringn #CheckSum|$3
Check-Sum (transferred as a string of fixed length equal to 3 characters)
The following examples are the transformation in script of the standard routine for the
transmission of a report by the analyzer to the host computer:

Stringn #PatientCode|$15
Char #PatientType
stringn #PatientNumberTest|$3

Set #BeginAnalysesData
Stringn #AnalysesCode|$04
Stringn #AnalysesConcentration2|$7
Set #EndAnalysesData

Stringn #CheckSum|$3

The details of the above scripts are as follows:

Stringn #PatientCode|$15
Patient Code of fixed length equal to 15 characters

Char #PatientType
Serum type (Serum/Urine) as single character

stringn #PatientNumberTest|$3
Number of results to be sent (a string of fixed length equal to 3 characters)

Set #BeginAnalysesData
Beginning of zone repeated for the number of results to be sent (see #PatientNumberTest)

Stringn #AnalysesCode|$04
An analysis code of fixed length equal to 4 characters

Stringn #AnalysesConcentration2|$7
Concentration referred to the analysis code as per #AnalysesCode (a string of fixed length
equal to 7 characters)

Set #EndAnalysesData
End of zone repeated for the number of results to be sent

Stringn #CheckSum|$3
Check-Sum (transferred as a string of fixed length equal to 3 characters)
4.2.1. SERIAL COMMUNICATION TEST PROGRAMS
Pr o g r am [Link]:
It is a simple communication program for sending command characters to the analyzer and
receive any response.
At the start the only input to the program is the number of the communication port (from 1 to
4).
A blue screen divided into two sections is displayed. In the upper section the characters
coming from the analyzer are displayed, while the lower section displays the characters
sent to the analyzer.
The only special keys used are F1 to clear the screen and F10 for exiting the program.
The special characters (with values less than 32) are displayed in ASCII notations along
with their values.
For example the Character EOT - value 4 - will be shown as EOT (4).
To send a special character (with values less than 32 or higher than 124) it is necessary to
keep pressed the ALT key and simultaneously to write the value of the character to be sent
using numerical keys. For example to send EOT it is necessary to keep the ALT key
pressed and simultaneously enter the value 4 through the numerical key and then release
the ALT key.

Pr o g r am B TPL [Link]:
It is a simple communication program that simulates the host computer. At the start it is
necessary to identify the number of communication port (from 1 to 4) and the desired
procedure (Transmission or Reception).
In case the Transmission is selected the program will ask for patient code (from 1 to 15
characters), the test number (from 1 to 9) and the relevant analysis code for each test (for
example: BUN).
It is a good practice to use the same analysis codes, which the analyzer has memorized in
the plate actually in use, if otherwise then an error will result in the transmission phase.
Now the program will execute an initialization procedure of communication with the
analyzer, will send patient data and wait for the outcome of transmission.
At the end the screen will display the outcome of the operation or show the position number
of the plate where the patient has been inserted or explanation of error code sent by the
instrument (for example: Patient Code Duplicated).
If the Reception procedure is selected, then the program will begin initialization of
communication with analyzer, will ask for data of the next report ready for serial dispatch
and show data of relevant downloaded report.
If there are no reports to be received, then a relevant message will be displayed.
Every time the program waits for a response from the analyzer, in case of problem it is
possible to abort the current operation by simply pressing the Esc (Escape) key.
Note:
Both the programs must reside in the computer connected serially to the analyzer through
appropriate cable indicated in the Operators Manual.
The computer must be an IBM compatible equipped with DOS operative system: Windows
95, Windows 98, or Windows 2000. The operating systems such as MAC, UNIX, Windows
ME or XP are not supported.
Since the programs operate in DOS ambience, therefore in case the Windows operating
system is used then it will be necessary to open a DOS shell (the command Prompts of MS-
DOS is found in the menu Programs, Accessories - accessed through the Start button on
the bottom left of the screen).
Both the programs use serial port with the following setups:

Baude-Rate....................... 9600
Stop-Bits........................... 1
Parity................................. None
Hand-shake...................... Hardware

Important Notice:
These two programs are in the installation disk under Utility folder.
 OPERATOR MANUAL
BT3000 PLUS

SECTION II: ADDITIONAL INFORMATION

CHAPTER 5
5. INSTALLATION OF THE OPERATING SYSTEM
5.1. Preliminary Phase Page: 2
5.2. Setup of the Operating System Page: 6
5-3. Completing the installation Page: 12
5-4. Settings of the Operating System Page: 14
5-5. Installation of BT3000 PLUS Program Page: 19
5-6. Upgrading the BT3000 PLUS software Page: 22
5. INSTALLATION OF THE OPERATING SYSTEM (OS)
CAUTION!
INSTALLATION OF THE OPERATING SYSTEM MUST BE DONE BY EXPERT PERSONNEL, AND
ONLY IN CASE THE OS HAS TO BE RE-INSTALLED EX-NOVO.
BEFORE STARTING ANY SOFTWARE INSTALLATION PROCEDURE, CONTACT THE AUTHORIZED
TECHNICAL PERSONNEL ONLY.

5-1. PRELIMINARY PHASE

1) Ensure that the BIOS has the following Boot configuration:
- Hard-Disk
- CD-ROM
- Drive A
2) Check that the mouse and the keyboard are properly connected.
3) Ensure that the following supplementary hardware has been correctly installed:
- Additional Serial
- Audio Card (optional)
- Network Interface Card (optional)
- Touch Screen
- Connecting cable between IBM & 552
4) Turn on the instrument and insert Windows 2000 disk in the CD-ROM drive
The following screen appears:

Press enter to initiate installation.

Now the screen displays the end-user license agreement for Microsoft Windows:

Press "F8" (I agree) to accept it.

Windows displays the existing partition of the hard disk:

Press "ENTER" to use the default partition.

Select "Format the partition using the FAT file system":

Press “ ENTER” to continue.

Now the Setup formats the hard disk and this phase may last for a few minutes:
Now the Setup copies files to the Windows 2000 installation folders in the hard disk and this
may take several minutes to complete:

At the end of preceding phase the system will restart (DO NOT REMOVE CD-ROM FROM
CD-ROM DRIVE).
5-2. SETUP OF THE OPERATING SYSTEM
After the restart, the system displays the "Setup Wizard" which will guide the user during
Setup of the Operating System:

Click “ NEXT” key to continue with Setup.

Now the Windows Setup detects the existing hardware and installs devices in the system.
This will take several minutes. In case the system halts (crash), that means some hardware
is not compatible with the system and/or the board utilized.

CAUTION
DO NOT INTERRUPT THIS OPERATION!!!
Now the Setup asks for setting the correct date and time for the system. One may skip this
now and set the date & time later.

After making appropriate corrections, click “ NEXT” key.

The Setup requests to enter Name of instrument and Organization:

Enter “ bt 3000 plus” as "Name" and “ biotecnica instruments S.p.A.” as

"Organizzazione" .
Click “ NEXT” key.
Now type the Product Key of Windows (the Product Key is composed of 5 groups of 5 characters
each):

The 25 character Product Key appears on the installation CD-ROM cover.

After typing the Product Key click “NEXT” key.
In case of incorrect Product Key entry, a message will alert the operator to enter the correct Product
Key.
Now provide the Administrator Password for your system:

In the field “ Administrator Password” type “ ENZO” and rewrite it in the field “ Confirm
Password” .
In case the board has a LAN (network) communication hardware, then the following
screens will be displayed:

Do not change the default parameters and click “ NEXT” in both the screens.
Now the Setup installs the Windows components and then completes the final set of tasks,
which may take several minutes:
The second phase of the installation has been successfully completed. Remove CD from
the drive. Click "Finish" to restart the system:
5-3. COMPLETING THE INSTALLATION
This is the most delicate phase of the whole process. If it is not performed correctly then it will be
necessary to repeat the whole installation procedure of the operating system.
A welcome message is displayed:

Click “ NEXT” key.

Enter user name who will log on to the system (STRICTLY OBSERVE THESE INSTRUCTIONS).

Enter “ Administrator” as “ User Name” .

Enter "ENZO" as "Password", which was also used in the previous installation phase.
Confirm password by rewriting it.
Click “NEXT” to continue.
The Windows installation has been completed. Click “ Finish” to exit.
5-4. SETTINGS OF THE OPERATING SYSTEM
Uncheck the box “ Show this screen at startup” (at the bottom left of the screen) and click
"Exit" (at the bottom right of the screen).

Open Control Panel: Click “Start” , point to “ Settings” , and click “ Control Panel” .
Double click on “Display” icon.

Select “ Settings” :

Set “ Screen area” to 800 by 600 pixels.

Click “ Yes” on the "Monitor Settings".

Go to “ Screen Saver” :

Click “ Power” (at the bottom right).

Select the settings "Never" in “ Turn off monitor” and “ Turn off disks” :

Click “ OK” .
If one desires to select a background picture go to "Background" page.

Select the desired background picture and set “ Stretch” in the "Picture Display".
Click “ OK” .
If a question is asked then respond by clicking “ Yes” :

The Operating System is now configured correctly and one may proceed to the installation
of the drivers of the peripheral devices (e.g. Additional Serial port, Touchscreen, and
printer).

CAUTION:
The supplementary drivers must be installed prior to installation of the BT3000 PLUS operating
program in the system.
5-5. INSTALLATION OF THE BT3000 PLUS OPERATING PROGRAM
Insert the CD-ROM containing the operating program of the BT3000 PLUS in the CD-ROM
drive.
The following screen appears:

Click “ LAUNCH SETUP” .

Now the installation procedure begins, which will guide the user during operating program
installation.

Click “ NEXT” .
The installation procedure automatically checks the communication port (COM) used for
communication with the 552. In case the communication port not found (cable disconnected, no
processor, etc.), the following screen "Select communication port" will appear:

Here the operator will manually select the Com port used for communication (normally "Com4"
is utilized).
Select Com4 and click “ Accept” . Now the installation of operating programs begins.
CAUTION:
DO NOT INTERRUPT THE ONGOING INSTALLATION, UNLESS FOR SERIOUS REASONS.
After the termination of previous phase, a message "Setup has finished installing bt Plus on
your computer" will be displayed:

Click “ Finish” .
Now a screen with various options for "End installation" (with restart or without restart of the
system) is displayed.
In case of the new installation, select "Yes, I want to restart my computer now" (first option).

Now the operating program has been installed correctly in the system.
5-6. UPGRADING THE BT3000 PLUS SOFTWARE
If a software upgrade disk is inserted or reinstallation of BT3000 PLUS program, then the
following screen is displayed:

Select the option “ Remove” and click “ NEXT” .

NOTE:
The ensuing procedure will remove only the executable files but not the data.

A screen "Confirm File Deletion" appears:

Click “ OK” .
Wait for the completion of the procedure:

Now click “ Finish” .

Now a screen with various options for "End installation" (with restart or without restart of the
system) is displayed.
Select the second option "No I will restart my computer later" (no reboot):

Now click “ Finish” .

Now the proper installation procedure begins:
- Open and close the CD-ROM drive to enable autorun (automatic starting) of the BT3000
PLUS.
 OPERATOR MANUAL
BT3000 PLUS

SECTION II: ADDITIONAL INFORMATION

CHAPTER 6
6. TECHNICAL ASSISTANCE Page: 2

Biotecnica Instruments S.p.A.

Via Licenza, 18
00156 Rome – ITALY
6. TECHNICAL ASSISTANCE

Please do not return any equipment or system before discussing your

application problem with a Biotecnica Instruments S.p.A. representative and
obtaining an Return Authorization. The Technical Assistance Department at
Biotecnica Instruments S.p.A. or your Biotecnica representative is available
for your assistance.
For other analyzer applications, your Biotecnica representative or Biotecnica
Instruments S.p.A. is eager to help you. Please feel free to call your
representative or the number below to discuss your application.

BIOTECNICA INSTRUMENTS S.p.A.

Via Licenza, 18
00156 – ROME
ITALY

℡ Tel. +39.06.4112316 Fax +39.06.4103079

Technical Assistance E-mail mciucci@[Link]

Biotecnica E-mail bt@[Link]

Website [Link]
 OPERATOR MANUAL
BT3000 PLUS

SECTION II: ADDITIONAL INFORMATION

CHAPTER 7
7. BIBLIOGRAPHY OF ALLIED SUBJECTS Page: 2

NOTE:
The following bibliography is given to supplement this manual,
whose scope as an operator manual permits only the mention or
brief explanation of some subjects.

Biotecnica Instruments S.p.A.

Via Licenza, 18
00155 Rome – ITALY
7. BIBLIOGRAPHY OF ALLIED SUBJECTS

♦ Burtis C.A., Ashwood E.R.: “ Tietz Textbook of Clinical Chemistry” IInd Ed. W.B.
Saunders Company, 1994

♦ Press W.H., Flannery B.P., Teukolsky S.A., Vetterling W.T.: “ Numerical Recipes” -
The Art Of Scientific Computing -, Cambridge Univ. Press, 1986

♦ EN 591 (1994): In vitro diagnostic systems – Requirements for user manuals for in
vitro diagnostic instruments for professional use (ital. UNI 96)

♦ EN 61010-1: Safety requirements for electrical equipment for measurement,

control and laboratory use – Part 1: General requirements (amendment to IEC
1010-1:1990 + A1:1992)

♦ EN 1658 (1996): Requirements for marking of in vitro diagnostic instruments

♦ Directive 98/79/EC on in vitro diagnostic medical devices (1998)

♦ EN 980 (1996): Graphical symbols for use in the labelling of medical devices
 OPERATOR MANUAL
BT3000 PLUS

SECTION II: ADDITIONAL INFORMATION

CHAPTER 8
8. LIST OF APPLICATIVE METHODOLOGIES Page: 2

Biot ecnica Inst rument s S.p.A.

Via Licenza, 18
00156 Rome – ITALY
8. LIST OF APPLICATIVE METHODOLOGIES
All available applicat ive met hodologies are resident in t he analyzer’ s hard disk.