BCI000002 Master T User Manual 1.1

Master T – User Manual
Master T
BCI000002
USER MANUAL 1.1
Related
Rev. Date Description
Section
Changed manual layout, some
1.1 03/2018 All
corrections
INDEX
INTRODUCTION ......................................................................................3
1 DESCRIPTION OF THE ANALYSER ..................................................3
2 INSTALLATION ...................................................................................6
2.1 Rear panel setting .................................................................................................... 6
2.2 Location of the instrument ........................................................................................ 7
2.3 Power supply connection and label .......................................................................... 7
2.4 Caution .................................................................................................................... 8
2.5 Incubator.................................................................................................................. 8
2.6 Printer settings ......................................................................................................... 9
3 MAIN MENU......................................................................................10
4 SETUP MENU ...................................................................................13
5 ARCHIVES MANAGEMENT .............................................................18
5.1 Edit method............................................................................................................ 22
5.2 Edit Control ............................................................................................................ 33
5.3 Graphic QC ............................................................................................................ 33
5.4 Delete Archives ...................................................................................................... 37
5.5 Delete Archiv. Method ............................................................................................ 37
6 OPERATING TIPS ............................................................................38
6.1 How to aspirate the liquids into the flow cell ........................................................... 38
6.2 Manual reading mode ............................................................................................ 38
6.3 Washing................................................................................................................. 40
6.4 Reset and switching off .......................................................................................... 40
7 RUN METHOD ..................................................................................41
7.1 Recall method ........................................................................................................ 41
7.2 Blank (Zero-setting) ............................................................................................... 45
7.3 Production of Standards ........................................................................................ 46
7.4 Standard confirm procedure ................................................................................... 46
7.5 Sample measuring ................................................................................................. 49
7.6 Flag Messages ...................................................................................................... 52
8 ABS MENU .......................................................................................54
9 WASHING .........................................................................................55
10 MAINTENANCE .............................................................................56
10.1 Cleaning procedures .............................................................................................. 56
10.2 First installation ...................................................................................................... 56
10.3 Everyday cleaning.................................................................................................. 56
10.4 Special cleaning ..................................................................................................... 56
10.5 Further advice ........................................................................................................ 57
2
INTRODUCTION
Thank you for choosing Hospitex Master T, a new instrument designed with powerful
features in a compact unit for biochemical investigations, enzymes, turbidimetry and
drug tests. With such characteristics as the easy to operate integrated touch screen,
the Master T is the perfect solution for you laboratory.
1 DESCRIPTION OF THE ANALYSER

The Master T technical features are:
- Touch screen with virtual alphanumeric keyboard.

- Multilingual capability, up to 6 different languages.
- 200 programmable tests.
- 1000 results storing capability categorized by date.
- Intelligent patient assay management
- Each test handles 3 different QC (quality control)
- Built-in incubation block.
- Integrated pump and flow cell.
- Programmable Aspiration features (With Re-run Capability).
- Internal pre-adjusted Peltier element at 25°C, 30°C and 37°C.
- 16 different QC values storage capability.
- 25 QC archives with 100 result capability.
3
It performs:
- End point
- Kinetic
- Fixed Time
- Multistandard assays
Results are shown by graphic display and printed on paper by built-in printer.
4
Technical specifications:
Graphic Display 320x240 (1/4 of VGA)

Patient name length 16 characters
Max test storage 1000 test
- PS2 external keyboard (connection on rear side of

External interface instrument)
- RS232
Light source Halogen lamp 12V, 20W. Automatic switch-off for stand-by
Photo detector Silicon based (range 300-1000nm)
Wavelength 340nm-700nm
Automatic via 8-position filter wheel;

Wavelength 6 standard interferential filters: 340nm, 405nm, 505nm,
selection 546nm, 578nm, 630nm.
Two free positions for optional filters
Photometric Range 0-2.5 O.D.
32L flow cell with 10mm light path, interchangeable with

Flow cell system disposable macro, semi-micro, or special optical glass
cuvettes
Reading time 1-999 seconds

Incubation time 5-999 seconds
Temperature control Peltier elements 25°C, 30°C and 37°C
Reaction volume Flow cell: 500 L per test / Macrocuvette: 1000L per test
Minimal
measurement 400 L
volume
Printer Graphic, 24 characters per line
Printing sort Batch, profile, reaction dynamics, QC print, Levey-

Jennings graph curves
Dimensions Length 42 cm x width 38 cm x height 25 cm
Weight Kg 11
Power supply 120/230 V AC 50/60 Hz
Hospitex International reserves the right to make changes to materials, equipment and models and to discontinue models at
any time without notice
5
2 INSTALLATION
2.1 Rear panel setting

Located in the rear panel (as shown below) you will find:
- Grid for internal cooling (a duplicate is located under the instrument).
- The power supply switch with fuses holder.
- The waste outlet.
- RS232 connection
- PS2 external standard keyboard connection
- Voltage selector
WASTE OUTLET: Before switching on the instrument, remember to connect the

plastic outlet connector (red) to a waste tank.
VOLTAGE PS2 RS 232

SELECTOR CONNECTION CONNECTION
POWER SUPPLY PERISTALTIC WASTE

SWITCH AND FUSES GRID PUMP OUTLET
6
2.2 Location of the instrument
The instrument should be located in a clean environment, placed on a stable surface,

and away from direct sunlight, which could affect the operating temperature and the
quantity of light measured by the instrument.
The following points should be taken into consideration.

- Ensure that it is on a level surface.
- Avoid positions subject to jerks or vibrations.
- Make sure that the instrument is not placed close to air conditioning or heat
sources.
- For the long life of the instrument these temperature conditions should be
followed.
5°C – 50°C for instrument storage.
15°C – 30°C for instrument use.
2.3 Power supply connection and label
- Please check the setting of the power supply switch according to your country’s
electrical network.
- Connect the power plug to a good grounded AC wall outlet, preferably one that
is not shared with other electric appliances and with low fluctuation of line
voltage compared to the standard voltage specified (10-15%).
- Keep the instrument away from other appliances that generate high frequency
electrical noises (e.g. radiological instruments).
- Before connecting the power cord, check that the AC power supply corresponds
to the value that is stated on the instrument’s label. Set the voltage selector
properly.
7
2.4 Caution
Do not connect the instrument to a power supply different from the value indicated on
the label.
- Before connecting the power and finishing the installation section, make sure
that the instrument is turned off (check the power switch located on the rear
part of the instrument).
- Make sure that your AC main line has an efficient ground line. A bad ground
line connection may compromise analysis results and damage the
instrument.
- After turning on the instrument, pay attention not to spill liquids or micro solid
substances on the surface around the instrument.
- Keep the instrument away from young children.
If the above procedures are carefully followed, you are now ready to TURN ON
the instrument by using the switch located on the rear panel.
2.5 Incubator
The incubator temperature is brought up to 37°C by the software and it will remain
Constant until the instrument is turned off.
Note: It is very important to heat the macro cuvettes to the proper temperature for
obtaining the most accurate analysis results.
Built-in incubation block
8
2.6 Printer settings
To insert the paper roll, proceed as follows:
- Pull the lever to open the cover as shown in step 1

- Take a new paper roll, insert it as shown in step 2
- Pull the edge of the paper out of the printer as shown in step 3
- Close the cover as shown in step 4
Step 1 Step 2
Step 3 Step 4
9
3 MAIN MENU
- Switch on: Turn on the instrument from the main power switch located behind
the instrument.
- First screen: User name screen, digit the operator code by pressing the keys
then press SAVE, now the software will proceed to main menu. The operator
code will be displayed at the beginning of each method analysis. To skip this
option and proceed to main menu just press EXIT
Main menu: The main menu is composed of 6 options, which can be selected by
scrolling over the messages. Every option is linked to a function of the instrument:
10
The main Master T functions are as following:
MESSAGE DESCRIPTION
Displays the list of assays available for a
Run method test.
Press EXIT to return to main menu.
Enters in the memory management of

Archives management the instrument.
Enters in the hardware and software

Set up settings of the instrument.
Absorbance reading: Press on this

message to enter in ABS test on sample
with programmable volume and filter
Utility
with zero option.
Host: Not active.
Printing options.
It will be possible to print:
- Patient test results

- Patient profile report
Printing
- QC values
- List of test
- Test Parameters
Activates the peristaltic pump for several

Washing seconds for rinsing the flow cell with
cleaning solution or distilled water.
11
This window shows the time and date

memorized in the instrument.
Time and Date
The instrument is equipped with a back
up battery so the memory is active also
when the instrument is switched off.
Time and date can be set from Setup

menu.
Feed button
Feeds paper out from the printer.
This window shows the current

temperature in the flow cell reading well
Temperature
When this number is flashing it means
that the temperature has not reached
the target; in these cases wait until the
indicator stop flashing.
This message shows the software

Software release
release loaded in the instrument.
In case of software update, this date will

change.
Use the up and down arrows to move to

Up and Down Arrows
different options over the touch screen.
The different options will be highlighted

once selected.
Enter arrow Enter button, once one option is

selected on the touch screen, in order to
confirm the choice press this button.
Exit Button
Press this button to exit from all menus
and return to main menu.
12
4 SETUP MENU
From main menu select Setup, the following screen will appear:
From the set up menu it is possible to customize the instrument features to best fit
the operator’s needs. Scroll the menu by using the up and down arrows.
MESSAGE DESCRIPTION
Select the flow cell working

temperature using the left and right
arrows.
Available temperatures: OFF, 25°C,

30°C, 37°C.
Note: If in the daily session there are

some analyses with method
temperature at 30°C, it is
Temperature cuvette recommended to perform these before
the others, in order to guarantee best
possible operation of the instrument.
The instrument will keep on running
even if this is not done, but the
precaution will ensure a perfect result.
The instrument will give a warning if
the temperature it is not reached when
a method execution is selected.
13
Select the language using the left and

right arrows.
Language Available languages: Portuguese,
English, Spanish, French, German,
Russian.
Enable or disable the printer using the

left and right arrows.
Print enable
YES: Print enable
NO: Print disable

Enable or disable printing the method
when it is selected to be executed by
using the left and right arrows.
Print method
YES: to print the method.
NO: not to print the method.
Press SAVE to store changes.

Enable or disable printing the result by
Print result YES: to print the result.
NO: not to print the result.
Enable or disable printing the curve

dynamics (for kinetic or fixed time) by
Graphic Print
YES: to print the dynamics.
NO: not to print the dynamics.

Not active in Master T. The incubator
Temperature Incubator
temperature is the same of the cuvette
Set the current hour using the number

Hour
keys
14
Set the current minutes using the

Minutes
number keys
Set the current day using the number

Day
keys
Set the current month using the

Month
number keys
Set the current year using the number

Year
keys
Note: The Master T aspiration is

divided in two actions:
Sample Aspiration: The pump

aspirates the volume amount set in
test parameters.
Air Gap: The pump aspirates a fixed

air amount after the sample has been
aspired.
Gap delay: This command inserts a

delay time between the sample
aspiration and the air gap aspiration.
Gap Delay (m seconds)
Delay time is defined in milliseconds.
This feature allows the operator to

prepare a sample test for a double
check using the same disposable
reaction cuvette:
Example:
1- Glucose 500µl volume for sample

test.
2- Prepare a double test solution to be

tested i.e.: 1 ml in cuvette.
3- Program delay time 3000
15
millisecond (equivalent to 3 seconds)
Set cuvette under inlet pipe and aspire

1st test by pressing the aspiration
switch, now you will have 3 seconds
time to extract the cuvette from the
inlet pipe.
After measurement, place the cuvette

under inlet pipe again and aspire 2nd
test by pressing the aspiration switch.
Note: Repetition of sample

measurement, by preparing double
reaction volume in the same cuvette,
is possible only if the operator has
sufficient time to extract the cuvette
from the inlet pipe before the air gap
(usually 150µl) is performed.
For deciding whether or not to activate

the peristaltic pump after sample
measurement to empty the flow cell.
Enable or disable the peristaltic pump
using the left and right arrows keys.
YES: After sample measurement the
pump will be activated and the sample
will empty into the waste bottle.
NO: After sample measurement, the
Automatic Empty
pump will be not be activated and the
sample will remain in the flow cell. In
this way it is possible to repeat the
reading by pressing the Rep. button
then touching directly the “Insert
sample” message in the touch screen.
In order to empty the flow cell, aspirate
a new sample or press Wash.
16
Smoothing level of the reaction curve,

Smoothing
only visualization.
When the option NO is selected, none
sample concentration result will be
calculated for the analysis that present
absorbance values lower than reagent
blank.
When Negative Abs option is
Negative Abs* activated, all samples absorbance
lower in value than reagent blank
absorbance, will be considered to
calculate the sample concentration.
Select option YES/NO by pressing
right and left arrows.
When the option NO is selected, the
instrument will not show the reagent
blank absorbance before executing a
test. When the option YES is selected
the instrument, will show before
starting a test, the reagent blank
Show Zero water*
absorbance. In order to show the test
reagent absorbance, the instrument
will require water first. Select option
YES/NO by pressing right and left
arrows.
This option is active only when the
methods archive is locked by the
Master code*
distributor, please refer to distributor
for unlock procedure.
Save button
Press this button to SAVE changes.
17
Exit Button
Press this button to exit from all
menus and return to main menu.
(*) Features available starting from

software release 02.001
5 ARCHIVES MANAGEMENT
Database dimensions
The Master T database memory is in two different hardware parts: EEPROM and
Flash memory.
The Master T archives are:
Languages: Up to 6 different languages managed.
Methods: 200 programmable methods
QC for each method: Up to 3 different QC levels for each method.
Results: 1000 results storage capability ordered by date.

This is a circular buffer and so the result number 1001 will be automatically assigned
to result number 1.
QC: Up to 16 different QC types can be memorized, each one holds 200 results.
QC results: 25 QC archives holding 100 results each.
Note: The Master T has 1000 test results memory capability.

If the test number exceed this capacity, the new values will be superimposed over
the old.
From main menu press Archives Management, the following screen will appear:
18
Press EXIT to return to main menu
MESSAGE DESCRIPTION
Edit the assay parameters settings of the

instrument.
A list of the entire assays present in the memory

Edit Method
will be displayed.
Press the relevant assay to be edited or viewed.
To return to main menu press EXIT.
Edit the Quality Control name list.
In this menu, it is possible to name the control

serums used in the QC menu.
Note: When the instrument is new no controls

Edit Control
names are saved in memory, the available
positions are displayed with the message: New QC
Note: It is possible to insert up to 16 control names.
Note: Up to 15 characters are allowed.
19
How to name a control:
- Select the first free position, a virtual

keyboard will appear.
- As operator requires, digit the control name

or Lot or the control concentration (low,
normal or high), then press SAVE.
- Now a new control name is displayed on the

list.
Note: the values of all the controls will be

memorized in the assay parameters.
How to delete a control:
- Select the control name to be deleted, a

virtual keyboard will appear.
- Press Del
- Press SAVE
In order to delete all the results and names resident

Delete Archives
in memory for all tests, press this button.
Delete Archive Method: In order to delete all the

results resident in memory for a specific test, press
this button.
Del Arch. Method The list of available assays will be displayed.
Select with the up and down arrows the test results

to be deleted for a specific method
Press the bin button, to delete.
In this menu, all the Control Quality values for all

the control serums saved in memory are displayed.
Select this option to view the Quality Control list.

Graphic QC
To view a assay QC database, select the relevant
assay, a QC will open showing the following:
- Levey-Jennings graph
20
- Westgard Rules
- Centred value
- Mean
- SD: Standard Deviation
- CV: Coefficient of Variation
Note: A Print button is available to print all the QC

values and their date of performance.
Note: A graph button is available to print the Levey-

Jennings plot.
Exit
Press this button to exit from all menus and return
to main menu.
This button is present in every assay of the Graphic

QC menu.
Edit Button
Press Edit to view and edit a specific value of the
QC database.
This button is present in every assay of the Graphic

QC menu.
Press this button to print the list of QC values for

each assay.
QC Print Format:
Print button
------------------------------------
11/01/2005
015 - GLUCOSE
Date ABS Result
09/02 0.345 1 01.4 mg/dl
10/02 0.341 100.2 mg/dl
12/02 0.347 101.9 mg/dl
N. Samples 3
Average: 101.1
CV 1.6
21
Graph button
Use this button to print the Levey-Jennings graph
Bin Button Press this button to delete the selected item.
- Delete method
- Delete Arch. Method
5.1 Edit method

Master T applications are loaded into the memory during System installation and
ready to use with Hospitex reagents.
Editing the assay parameter files incorrectly may affect the calculation of the results
and may produce erroneous results. Verify edits to the assay parameter files against
the Master T assay applications.
Press Archive Management menu and the following screen will appear:
Choose Edit method, the list of assays present in memory will appear.
22
- Use the up and down arrows to move to different options over the screen.
The different option will be highlighted once selected.
- Use the Page up and down buttons to move to browse between the list
pages.
- Use the Home and End buttons to move to the limits of the list.
In the Edit method menu there are three options:
- Create a new method

- Edit a method present in memory
- Delete a method
Select one method and the relevant parameters will appear as follow:
MESSAGE DESCRIPTION
Select this option and press virtual keyboard,

insert the Assay name then press SAVE.
N. Method
The name will be saved in the memory and
showed in the list.
Method Reading Type:
- EP: END POINT
- KIN: KINETIC
Method Type - FXT: FIXED TIME
- EIA: ELISA
Select the different options by using the left and

right arrows keys.
23
Setting the instrument to Zero:
- WATER
- BLANK
Zero
- SAMPLE BLANK

right arrows.
Measure units: g/dl, mg/dl, g/dl, g/l, mg/l, g/l,

g/ml mg/ml UI/l, UI/dl UI/ml, mUI/ml, mEq/l,
Units mol/l, nmol/l, mmol/l, %, ABS

right arrows.
Flow cell temperature:
OFF (room temperature)
25°C
Temperature 30°C
37°C

right arrows keys.
Different selection possibilities will appear

according to the calibration mode chosen.

right arrows.
Factor calibration:
- Select: Calibration NO
Calibration
- Then press down arrow
- The Factor box will be displayed.
- Insert the numeric value for the factor.
Use the number keys to enter the
numeric value, press C to delete.
24
Standard calibration:
- Select: Calibration YES

- Then press the down arrow
- The Standard N and Standard boxes
will be displayed.
- Insert the number of standard by using
the left and right arrows (from 1 to 9).
- Then press the down arrow
- Insert the standard concentration values.
(the standard values required are equal
to the standard number inserted).
Note: In order to display all the concentrations,

use the up & down arrow keys to choose the
amount of times needed (for example: if 5 has
been chosen as the number of the standard
and all the standard concentrations have been
inserted, use the keys to scroll and check all
the standard concentration).
The standards must be inserted from the

lowest to the highest value
Sample (µl) Insert the sample volume used in the assay.
Insert the Reagent 1 volume in microliters.

Reagent 1 (µl) Note: Sample volume + Reagent 1 volume +
Reagent 2 volume >= 400 µl
Reagent 2 (µl) Insert the Reagent 2 volume in microliters.
Select the method wavelength required; the

Filter 1 different filters can be selected by using the left
and right arrows keys.
Select the second wavelength (optional), if

Filter 2 requested by the method; the different filters
can be selected using the left and right arrows
25
keys.
Note: The Filter 2 option is available only for

End Point and Elisa methods.
Insert Maximum normality population value for

the method parameter.
Note: If this option is not programmed (i.e. all

Normal Max
values are left at zero), the software will not
take these values into consideration when
checking the results.
Insert Minimum normality population value for

the method parameter.

Normal Min
Insert the maximum Abs value for samples that

method reaction supports (this value depends
on reagent specifications and methods
parameter inserted).
This value is important to evaluate reactions

Max. ABS
with positive gradient.

Insert the min. Abs value for samples that

method reaction supports. (This value is useful
to detect problems of not active or too much
Min. ABS
active reaction).
This value is important to evaluate reaction with

negative gradient.
26

Insert the maximum Delta Abs (ABS) value for

samples that method reaction supports (this
value depends on reagent specifications and
methods parameter inserted).
Delta ABS
The delay time is the length of time between

the moment at which the sample is placed into
the flow cell (or cuvette) and the point when
temperature and motion within the sample
stabilizes. In this software it is not
programmable and it amounts to 2 seconds.
The Incubation time is the period of time that

the reaction needs to develop its real ABS
gradient. This time is always greater than delay
time so the delay is not considered for kinetic
Inc. Time and fixed time. In fact the software provides a
Master T minimum incubation time of 10
seconds.
ABS
Delay time sec

Reading time
Incubation
time
27
Digit the reading time (in seconds) for the

reaction by using the side number keyboard.
The Reading time is the period of time the

reaction takes to reach its real speed and
during this time the instrument achieves one
Reading Time
measure per second.
Note: The Reading time for EP method is fixed.
Note: Reading time option will be available

only if Kinetic and Fixed time reading type have
been selected.
Select one of the QC control names, previously

programmed in Edit controls menu.
Name QC 1
View the different Controls by using the left and
right arrows.
Value QC 1 Digit the control serum centred value for this

specific assay by using the side number
keyboard.
Digit the control serum 1 SD value for this

Standard Dev. QC 1
specific assay by using the touch keyboard.
In order to use a second control serum

programmed in Edit controls menu, select one
of the QC control names, previously
Name QC 2
View the different controls by using the left and
right arrows.
Note: The QC 2 must be different from the QC 1
Digit the control serum centred value for this

Value QC 2 specific assay by using the side number
keyboard.
28

Standard Dev. QC 2 specific assay by using the side number
keyboard.
In order to use a third control serum

programmed in Edit controls menu, select one
of the QC control names, previously
Name QC 3
View the different Controls by using the left and

right arrows.
Digit the control serum centred value for this

Value QC 3

Standard Dev. QC 3
Keyboard Press this button to recall the virtual keyboard

for the following:
- Name an Assay Method
Save button
Press this button to SAVE changes.
Use the up and down arrows to move to

Up and Down Arrows
different options over the touch screen.
The different option will be highlighted once

selected.
Exit Button
Press this button to exit from all menus and
return to main menu.
29
List of the assay parameters requirements for each test:
FIELD EP KIN Elisa FXT Note
Max characters allowed

1 Name * * * * 16, max characters
displayed 11
Type of reading:
2 Type * * * * Kinetic, Endpoint, Fixed
Time, Elisa
0 = H2O, 1 = Blank,
3 Zero * * * *
2 = Sample Blank
4 Units * * * * See table
0=OFF, 1= 25°C, 2=30°C,
5 Temperature * * * *
3=37°C
6 Calibration * * * * Type of Calibration
7 STD Number * * * * Number of Standard (1-9)
STD conc. Standard Concentration
8 * * * *
[max 9] Value
K Factor (Range 0.01-
9 K Factor * * * *
99999)
10 Sample (μl) * * * * Sample volume (Min 1 μl)
Reagent 1 volume (Min>=
11 Reagent 1 * * * *
100 uL, Max 3000 uL)
Reagent 2 volume (Range
1- 999 uL)
12 Reagent 2 * * * *
R1+R2+S<=400 uL not
allowed
13 Filter 1 * * * *
14 Filter 2 * *
Max normality
15 Normal Max * * * * concentration
(Range 0.001-99999)
Min normality
16 Normal Min * * * * concentration
(Range 0.001-99999)
30
Max Concentration value

17 Linearity Max * *
(Range 0.001-99999)
Maximum Initial ABS
18 Max ABS * * * *
2.5
Minimum Initial ABS
19 Min ABS * * * *
(0.001)
Maximum Delta ABS
20 Delta ABS * *
(0.001-2.5)
Incubation Time
21 Time Inc. * * * *
(Range 10-300)
EP = Fixed
22 Time Read * * * KIN FXT = Reading time
(Range 10-300)
23 Name QC1 * * * * Select Qc name from list
Insert control value
24 Value QC1 * * * *
25 Stand. Dev. QC1 * * * * Insert SD value

27 Value QC2 * * * * Insert control value
30 Value QC3 * * * * Insert control value
Note:
In order to avoid errors in method running (during a set series of experiments), it is
important not to modify the CALIBRATION and the method TYPE once the series of
experiments has begun. Any modification to one specific methods parameter will
automatically erase the calibration in memory, a new calibration procedure will be
request before being able to run the method.
31
Create New Method:
- Look for the first free position stated as “NEW METHOD” in the assay list
using the Up and Down arrow buttons.
- Select and enter inside the method parameters.
- Name method and set assay parameters following assay producer
specification.
- Save and Exit.
Edit method:
- Select end enter in the method to be edited.

- Make changes.
- Save and Exit.
Erase method:
- Select end enter in the method to be deleted.

- Select N. Method line and press the virtual keyboard button.
- An edit screen for the name will open, press Del. Button and erase name.
- Press save.
- Exit the method parameter.
- Confirm changes, the method will be erase and reported as “NEW METHOD”
in the list.
32
5.2 Edit Control

This enables you to enter a control serum name list. Insert Control name, all the
methods saved in memory will be displayed in this list.
There are 16 free positions for the QC control serum name.

In EDIT, all names for a specific control serum can be updated. Control information
and Control values to be assigned to the new Control, will be inserted from methods
parameters located in memory (See Edit methods).
- Press NEW QC to insert new name of new control in memory.
- A virtual keyboard will open, digit the name.
- Press SAVE to set the name in memory.
- Press DEL and then SAVE to delete from list a control list.
5.3 Graphic QC
In Graphic menu it is possible to view and edit method values for each control
serums previously memorized.
The different control defined on the Edit Control page, will be then be displayed in the
method parameters in order select QC (Control Quality) procedure.
Westgard rules
Levey
Jennings
graph
QC
Statistic
values
33
When QC results are completed with no errors, the results are saved in the Graphic
QC menu. The QC values and statistics can be viewed from this menu.
The Quality menu will report quality assay status, Levey-Jennings graph, QC Data
List and Westgard Rules.
Expected concentration and SD can be defined for the methods parameters, and
Westgards Rules can be view to evaluate the QC. If a Westgard Rule is violated the
OK message will disappear.
Levey-Jennings graphs will be displayed on left side of touch screen and QC

Summary Table on the right side.
The QC Summary Table displays the Westgard QC Rules and Statistics for all the
assay and levels of QC.
To view the QC Summary screen, select the EDIT button.
BUTTON DESCRIPTION
The system holds all the QC values points, in

case some QC values need to be excluded
from the QC statistics due to a wrong
processing of QC perform the following steps:
Press this button to visualize the entire QC

values list and their relevant data.
Select the QC value that need to be excluded,

and press the recycle bin button. Once the
value is null a letter “*” will appear beside it.
To restore the excluded value, select and press

Enter.
CODES:
N: Normal QC value falls in the ±2SD range

defined for the test.
H: QC result value is higher than +2SD range

L: QC result value is lower than -2SD range

34
“ * “: Excluded QC value.
In order to print all the QC values list for a

control serum, press this button
In order to print the Levey-Jennings graph,

press this button.
Exit from menu
The following table defines each column of the QC Statistics:
MESSAGE DESCRIPTION
The expected concentration defined in the

VALUE
calibrator menu
MEAN The actual mean of the QC
SD The actual standard deviation of the QC
The actual coefficient of variation of the QC
CV
data
The following table defines each column of the Westgard Rules information:
RULE WESTGARD RULES DESCRIPTION
One control value exceeds ± 2 standard deviation.

1_2S
One control value exceeds ± 3 standard deviation.

1_3S
Two consecutive control values for one level exceed ± 2

2_2S
standard deviation.
The difference between two consecutive controls values

R_4S
exceeds 4 standard deviation.
Four consecutive controls values for one level exceeds ±

4_1S
1 standard deviation.
Ten consecutive controls values for one level lie on one

10X
side of the mean.
35
Westgard Rules abbreviation messages:

OK = The rule is satisfied
Other sign = The rule is not satisfied
No sign = The rule cannot be applied. (On rule 5 at least 4 readings are needed and
on rule 6 at least 10)
Levey-Jennings graphs will be displayed on left side of screen:
DESCRIPTION
The graph area displays the ± 1SD range, ± 2

SD range, ± 3 SD range. Each accepted QC
value within the ± 3 SD range is displayed as a
dot on the graph.
Area of the graph
Note: If the value is greater than ± 3 SD, it is

displayed as a point at the top or bottom of
graph.
Centred value of the control serum.
The left side of the graph, displays the SD

±
(Standard Deviation range)
The lowest right part of the graph, displays the
FIRST
date of the first QC value performed.
The lowest left part of the graph, displays the
LAST
date of the last QC value performed.
36
5.4 Delete Archives

From this menu, it is possible to delete all the patient data stored in the memory.
How to delete:
- Press “Delete Archives”

- A confirmation message will appear
- Press YES to delete all the patient database results
- Press No to exit
Note: The Master T patient database has a total memory capability of 1000 tests.
When the reserved memory space is full, new test results will superimpose the older.
Because of this, we suggest printing the patient test results at the end of each
working session (Batch or Profile print), or at the same time as the test is performed.
5.5 Delete Archiv. Method

From this menu, it is possible to delete all patient data stored in memory only for a
specific assay selected.
This feature can be useful when a wrong ID number has been inserted.
The ID number’s current order is automatically generated, but the operator can
insert an ID as preferred (from 1 to 9999).
If an ID number that is too high has been wrongly inserted, such as 9999, the system
will block the possibility to operate the test. In this case to be able to continue it is
necessary to delete the Archive for this specific method.
How to delete:
- Press “Del. Arch. Method”
- The list of tests will appear
- Scroll (highlight) with the up and down arrows the method from the database
that must be deleted.
- Press the Bin Button.
- A confirmation message will appear
- Press YES to delete all the patient database results
- Press No to exit
37
6 OPERATING TIPS
6.1 How to aspirate the liquids into the flow cell

After pressing the aspiration switch, this device will aspirate the correct amount of
liquid volume according to the method settings and it will stop the aspiration after a
perfect filling of the flow cell.
Additionally, in order to reduce interference and carryover, an air gap will be

automatically created between one sample and another
Instruction for a correct aspiration:
1. Prepare disposable cuvettes

with correct amount of reagent
and sample volume according
ASPIRATION TIP to the method.
2. Set aspiration tip inside

CUVETTE cuvette, be sure that
aspiration tip is laying in one
corner of the cuvette (see
figure A)
Figure A
3. Then press the aspiration

switch, the sample will be
aspired automatically.
6.2 Manual reading mode
To perform a measurement manually with a disposable cuvette, see the following

instruction:
- Switch off the instrument.

- Extract the flow cell from the reading well and leave it free inside the
measurement block
- Switch on the instrument.
- Now it is possible to read manually the Macrocuvette, insert the cuvette into
reading well.
38
- To take measurement press the aspiration switch or touch the help window on
display.
- Read the sample.
- Repeat same operation for the following samples.
When using the cuvette disposable Macrocuvette, make sure there is at least 1000
µL of total volume of Reagent + Sample in the manual cuvette.
Then insert the manual cuvette in the cuvette position and press the aspiration switch
or touch the help window on display.
Make sure to position the manual Macrocuvette correctly, THE READING SURFACE
MUST BE FROM LEFT TO RIGHT of instrument, as follows:
Macrocuvette
Macrocuvette reading surface Macrocuvette reading surface
Reading well
39
6.3 Washing
After each session of measurements, it is recommended that the flow cell be washed
with distilled water.
Washing is possible every time, in Run Mode or in ABS Mode.
For washing the flow cell press the ‘Washing’ command so the pump will drain away
the water at high speed into the flow cell.
After washing, it is necessary to repeat the operation without water so that the water
remaining inside the instrument can be expelled completely. It is very important to not
alter the next measure.
6.4 Reset and switching off

In case of software failure it is always possible to reset the instrument by switching
off the main power switch.
It is possible to reset at any time and in all the software’s menu without compromising
the instrument’s functionality.
To reset the instrument:

- Turn off the switch.
- Wait for 10 seconds.
- Turn on the switch.
Remember that the instrument must only be reset if the software does not work.
To Switch off the instrument:

- Turn off the main switch
40
7 RUN METHOD
From Main screen select Run Method, the list of all tests present in memory will be
displayed.
7.1 Recall method

- Use the Page Up and Page Down buttons to scroll through the test list.
- Use the up and down arrows to select the test to be run, once the test is
highlighted press Enter.
After a method has been chosen, the run screen will appear as follow:
41
The Run screen is divided in 12 windows, some of them are just for data visualization
(the touch screen feature is not active in such zones), the other windows show
information and the touch screen feature is active:
MESSAGE/BUTTON DESCRIPTION
Shows the list number of the method (from 001
Number and Method to 200) and the name of the test.
name Note: The Touch screen is not active in this

position.
Insert patient name.
Touch the screen, a virtual keyboard will open,

digit the patient name if necessary then press
Patient Name
SAVE button.
The Patient Name will be now appear on the

main screen.
Absorbance of the current reading.

ABS Note: The Touch screen is not active in this
position.
Concentration result of the current reading.

Res Note: The Touch screen is not active in this
position.
Patient Identification Number (ID).
ID assignment criterion:
The ID number is automatically set at 1 when

the first sample of the first assay is run for the
Id
first time of the day.
The first free ID for each Assay will
automatically appear once the test has been
recalled.
In the patient database each ID corresponds to
42
only one patient name; it is not possible to have

the same patient name linked to different ID
numbers.
This box displays the factor of the method.
If the factor needs to be carried out (calibration)

and no factor value is present in memory a
sequence of stars (****) will be displayed.
K (Factor value)
The instrument keeps in memory the last value
also when the instrument is switched off.
Note: The Touch screen is not active in this

position.
Standard concentration Value (STD)
In case of need, the STD value can be edited

directly from this box without needing to enter
S (Standard value in the edit method menu.
concentration) How to edit:
After blank measurement has been performed

touch the STD box and the STD edit screen will
open, digit the new standard value and save.
Press this button to activate the peristaltic

pump for 10 seconds.
This feature cleans the flow cell with distilled

Wash
water or bleach.
Note: Do not use corrosive reagents because

they may damage the metal flow cell.
In order to repeat the reading for the same ID

(same patient) press Rep. and sample is read
Rep.
again, the new result will superimposed the
previous one.
43
Next Visualizes the next free ID number.
Feed Press this button for paper feed.
The help bar has 2 different functions:
- The bar displays a sequence of

messages, touch the message to initiate
one order.
- When the bar displays reading
messages, i.e. “”Insert blank”, “Insert
Standard”, “Insert sample” by touching it
Help Window will start the reading command.
The help window bar is useful to:
- Perform manual reading using

disposable cuvettes.
- Repeat readings of same sample. In
order to do this it is necessary to disable
from setup menu automatic empty of
peristaltic pump.
Press this button to print the reaction dynamic

Print Reaction Dynamic
graph.
Displays the actual flow cell temperature

Flow Cell Temperature
previously selected from setup menu.
This is the time bar. The black bar will advance

Time Indicator showing the remaining time before end of
reaction reading.
Depending on which method is running the

reaction graph will display the following:
Reaction Graphical
End Point and Fixed Time methods:
Display
On axis of abscises reports concentration
value.
44
On axis of ordinates reports the absorbance

value.
The calibration line is normally displayed.
Kinetics methods:
During the kinetic readings this graph displays

the reaction dynamic in real time.
Once the method is loaded, its parameter will be automatically printed. To decide
whether or not to print automatically the method parameters, please refer to setup
menu for information about printing format.
7.2 Blank (Zero-setting)
The Blank is performed each time the absorbance zero is required from method
parameters:
- When water or reagent blank is chosen, the zero protocol is performed only
once, at the beginning of the running method.
- When sample blank zero is chosen, the zero protocol is performed at the
beginning of each measurement (standard or sample measurement) of the
relevant running session.
Before pressing the aspiration switch, after every standard or sample
measurement, it is necessary to fill the flow cell with zero solution again, after
this operation it is possible to proceed to a new standard or sample
measurement.
45
7.3 Production of Standards
The standard measurement is performed when the standard calibration type

requires:
- When standard calibration is selected, perform the standard measurement.

- When multi calibration is selected, perform for each standard a
measurement for the number of times equal to the number of repetitions
programmed in the method.
- The standard protocol is not performed with the Factor calibration so, in this
case, after the Blank/Water zero setting, the program goes directly to the
sample measurement.
Note: Every time that you change the following parameters:

- Method type.
- Zero type.
- Calibration type.
- Filters.
- Volumes (sample or reagent).
- Incubation and reading time.
The stored standards calibration factors are erased.
7.4 Standard confirm procedure
If the current method has been performed at least once, the old standard results will
be retained in the memory and must be reviewed, confirmed, or modified.
If instead the current method has not been previously performed, the standard value
will not appear and the calibration procedure in the help window will automatically
be displayed.
The first time that the program runs the old factor is the current factor.
The first time that the program runs the old standard session is the current standard
session.
46
Procedure:
Once a method is recalled from the list, it will ask for calibration in the help window
box as follow:
1) CALIBRATING METHOD? YES/NO
Press YES to calibrate again the method.
Press NO to skip the new calibration.
2)
NEW BLANK? YES/NO
Press YES to perform blank reading.
Press NO to skip to standard reading (point 4).
3) INSERT BLANK
Set up (according to the zero type) the water or reagent blank test tube and fill the
flow cell by pressing the aspiration switch.
Wait for a delay time (5 sec.) for the environment to stabilize.
ABS blank value will be acquired.
4) INSERT STANDARD
Set up the standard solution tube and fill the flow cell by pressing the aspiration
switch.
Wait for a delay time (5 sec.) for the environment to stabilize.
Calibration value will be acquired, the K factor will be displayed in the relevant box,
the instrument will wait for confirmation order as follow:
ACCEPT CALIBRATION? YES/NO
Press YES to accept the value and proceed to patient analyses.
47
Press NO to refuse last calibration procedure, the help window will ask the
following:
REPEAT CALIBRATION? YES/NO
Press YES to repeat calibration from point 4
Press NO If the new measurement is unsatisfactory, it is possible to recover the

previous standard and proceed to patient analyses.
In case no calibration factor has been stored in the memory, the instrument will
require the calibration as mandatory, starting from point 3.
All calibrations, single point or multipoint will be graphically visualized on the screen.
48
7.5 Sample measuring

It is now possible to measure the samples.
For Kinetic and Fixed Time methods the ABS symbol has to be considered as a delta
absorbance value.
To run the program, set in place the test tube with the sample and press the
aspiration switch. The instrument will fill the flow cell, take a measurement, and then
expel the sample.
During the run for End Point and Elisa methods the screen appears as follows:
For End Point and Elisa methods, after the delay time, the result of the ABS
standard measurement and the concentration value are displayed. The result of the
sample concentration has a supervisor control (see Flag messages):
- The current sample order number.

- The absorbance value.
- The reading time evolution.
- The current working temperature of the flow cell.
- The graphic calibration point.
49
During the incubation time and reading time for Kinetic and Fixed Time methods the
program will display the following screen:
During the reading time for Kinetic and Fixed Time methods the screen shows:
- The current sample order number.

- The delta absorbance evolution and the initial and final absorbance values.
- The reading time evolution.
- The current working temperature of the flow cell.
- After the first ten seconds of the reading time, a real time graphic dynamics of
the measurement is shown on screen. The graphic point can be dispersed
because the real trend is displayed.
- The result of the sample concentration at the end of the measurement, with a
supervisor control (see Flag messages).
Name assignment criterion:

Before performing patient analysis, touch the Nm patient name box, a virtual
keyboard will open, digit the patient’s name and save. It is now possible to perform
the test.
The patient name corresponds to only one patient ID for these analyses.
Analyses measurement can still be performed without assigning a patient name.
50
ID assignment criterion:
The ID number is set automatically to 1 when the first sample of the first assay is run
for the first time of the day.
The first available ID for each Assay will appear automatically once the test has been
recalled.
In the patient database each ID correspond to only one patient name; it is not
possible to have the same patient name linked to a different ID number.
To change the patient ID, touch the ID box and a virtual keyboard will open, insert the
required ID exit and save. Now the next patient will be identified with the
programmed ID number.
Test Patient repetition measurement
- Just after a patient measurement it is possible to repeat again with the same
solution in the cuvette. In order to do this press the REP button on the screen
and read, the new measurement value will superimpose over the old one.
- If the sample repetition will be performed a second time, touch the ID box and
a virtual keyboard will open, insert the required ID exit and save. Now the
results of the recalled patient for that analysis will be displayed, press the REP
button on the screen and read again, the new measurement value will
superimpose the old one.
Note: To perform repetition of readings using the flow cell, it is necessary to disable
the automatic waste function. In this way the peristaltic pump will be not activated
after patient measurement and the sample will remain in the flow cell for repetition.
To disable automatic serum discharge, go in Setup menu and set to NO automatic
empty, save and exit.
To perform repetition of readings using the manual cuvette, it is not necessary to
disable the automatic waste function.
51
Processing QC controls
In order to insert in the QC database a control serum value for a specific assay
proceed as follow:
- During the run session, it is possible to insert 3 control types (QC1 – QC2 –
QC3) for each method type.
- To process a QC value, touch the ID box and the virtual keyboard will open.
- Now it is possible to choose between 3 different QC (QC1 – QC2 – QC3)
stated in the keyboard keys.
- Once the selection is done, the QC will appear automatically in the Nm patient
name box.
- Once the QC reading measurement has been processed the result will be
saved in the database.
- The QC database can memorize up to 25 archives containing 100 results
each; any archives with more than 100 results will substitute the oldest for the
newest (circular buffer).
7.6 Flag Messages

The following Message Flags might appear while performing sample assays in the
RUN menu and will print beside the concentration result:
MESSAGE
MEANING DESCRIPTION
FLAG
Probable Cause
Pathological evidence
Patient result
value is higher Corrective Action
H of normality
Review the result and report as over
range defined
for test. the normality high range value.
Dilute the sample and rerun.
Probable Cause
Pathological evidence
Patient result Corrective Action
value is lower
L of normality Review the result and report as under
range defined the normality low range value.
for test.
Concentrate sample and rerun.
52
Result concentration value > Max.

Conc. value defined for the test in Control
menu.
Probable Cause
Linearity high Sample concentration is greater than the
D
(Concentration) Reaction Linearity Range defined on the
parameter page of the Method

Corrective Actions
ABS value > Max. ABS. value defined in
Control menu. (For Kin and FXT)
Probable Cause
Linearity high Sample ABS value is greater than the
M (Expressed in Reaction Linearity Range defined on the
ABS value)
parameter page of the Method
Corrective Actions
ABS value < Min. ABS. value defined in
Control menu. (For Kin and FXT)
Probable Cause
Sample ABS value is less than the
Linearity low Reaction linearity Range defined on the
m (Expressed in parameters page of the Method
ABS value)
Corrective Actions
Review the result and report as less than
the Linearity low range value.
Concentrate the sample and rerun.
 ABS reaction test value>ABS
Max.Delta
Reaction check Probable Cause
for Delta value
(Expressed in Sample concentration is greater than the
D
 ABS) is Reaction Linearity Range defined on the
outside the
parameters page of the Method
range
Corrective Actions
53
The target temperature for reading well

(25, 30 or 37 °C) has not been reached.
Probable Cause
Target Not The instrument is has just been switched

T Reached
on.
Corrective Action
Wait some minutes for the temperature to

increase. Wait for temperature target.
8 ABS MENU
ABS mode is a service function, useful to test the ABS of a sample with a
programmable wavelength. To use this function, you must set the instrument to zero
with a reference (for example water or reactive).
When the program arrives to this screen, the instrument will set up the optical filter
(showing the current wavelength), select a different one if necessary using the
arrows, press the filter wheel icon to set the new wavelength.
Set the test tube of water (or other substances) in the inlet pipe and press the
aspiration button, after a few seconds, continuous evolution of the ABS value will
appear on the display. During this phase the following options could be chosen:
- Press 0 key to have zero on the current ABS value (water or other
substances). You will choose this option when you will set to zero the
instrument.
- Prepare a new sample (reagents, potassium-dichromate or others) and press
the aspiration switch to start a new ABS measurement session.
It is possible to print the ABS values on the internal thermal printer.

At the screen exit, the instrument expels the volume from flow cell via the outlet
waste.
Selection keys:
- Press the aspiration switch to fill the flow cell with the sample.
- Press 0 key to choose the zero value.
- Press Exit button to return to main menu.
54
9 WASHING
After each session of measurements, it is recommended that the flow cell be washed
with distilled water.
Washing is possible in:
- MAIN menu
- RUN Mode
- ABS Mode.
For washing the flow cell set the tube with water in the inlet pipe and press the Wash
button so the pump will aspirate water and wash it.
After the washing, it is necessary to repeat the operation without water so that the
water remaining inside the instrument can be expelled completely. It is very important
to not alter the following measure.
55
10 MAINTENANCE
10.1 Cleaning procedures

Press the washing command to activate the peristaltic pump for flow cell washing.
The peristaltic pump will aspire for several seconds in order to aspirate distilled water
or cleaning solutions.
This feature is achievable in several instrument menu (also during sample readings)
10.2 First installation
Perform at least 10 complete washing cycles by using the Washing procedure. Every
washing cycle lasts approx. 1 minute and stops automatically.
10.3 Everyday cleaning
At the end of each working session, it is recommended to rinse the instrument with
detergent solution or alcohol via the inlet pipe. Place a cup of detergent solution
under the inlet pipe and carry out the Washing procedure.
Empty the waste tank: The waste bottle and all tubings contain sample and reagent
material. This material should be treated as potentially bio hazardous. Appropriate
waste management should be observed!
10.4 Special cleaning

Every month perform at least 2 complete washing cycles with sodium hypochlorite
(bleach) by using the Washing procedure.
N.B.: Do not use corrosive detergents to wash the instrument.
56
10.5 Further advice
Further advice for correct use and maintenance of the instrument
- If the instrument is not being used for a long period of time, empty the
hydraulic circuit and disconnect the tubes.
- When the instrument is in use, keep the two little doors of the instrument
(measurement block and printer doors) firmly closed.
- Clean the external surface of the instrument every month with a non-abrasive
detergent.
- Clean the surface near the fan grids every month in order to take off
dangerous dust.
57

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Master T – User Manual

1 DESCRIPTION OF THE ANALYSER

- Touch screen with virtual alphanumeric keyboard.

Graphic Display 320x240 (1/4 of VGA)

- PS2 external keyboard (connection on rear side of

Automatic via 8-position filter wheel;

Photometric Range 0-2.5 O.D.

32L flow cell with 10mm light path, interchangeable with

Reading time 1-999 seconds

Printer Graphic, 24 characters per line

Printing sort Batch, profile, reaction dynamics, QC print, Levey-

2.1 Rear panel setting

WASTE OUTLET: Before switching on the instrument, remember to connect the

VOLTAGE PS2 RS 232

POWER SUPPLY PERISTALTIC WASTE

2.2 Location of the instrument

The instrument should be located in a clean environment, placed on a stable surface,

The following points should be taken into consideration.

15°C – 30°C for instrument use.

2.3 Power supply connection and label

Built-in incubation block

2.6 Printer settings

To insert the paper roll, proceed as follows:

- Pull the lever to open the cover as shown in step 1

The main Master T functions are as following:

Displays the list of assays available for a

Run method test.

Press EXIT to return to main menu.

Enters in the memory management of

Press EXIT to return to main menu.

Enters in the hardware and software

Press EXIT to return to main menu.

Absorbance reading: Press on this

It will be possible to print:

- Patient test results

Press EXIT to return to main menu.

Activates the peristaltic pump for several

This window shows the time and date

Time and date can be set from Setup

This window shows the current

This message shows the software

In case of software update, this date will

Use the up and down arrows to move to

The different options will be highlighted

Enter arrow Enter button, once one option is

Select the flow cell working

Available temperatures: OFF, 25°C,

Note: If in the daily session there are

Select the language using the left and

Enable or disable the printer using the

NO: Print disable

NO: not to print the method.

Press SAVE to store changes.

Print result YES: to print the result.

NO: not to print the result.

Press SAVE to store changes.

Enable or disable printing the curve

NO: not to print the dynamics.

Press SAVE to store changes.

Set the current hour using the number

Set the current minutes using the

Set the current day using the number