User Manual MASTER T VER 3.1

HOSPITEX INTERNATIONAL
MASTER T
User Manual 3.1
HOSPITEX INTERNATIONAL S.R.L.

Via Baldanzese, 37
50041 Calenzano, Florence
Italy
Tel. +39-055-0135766
HOSPITEX INTERNATIONAL User Manual Master T
INTRODUCTION……………..………………………………………………….. 4
Section 1 DESCRIPTION OF THE ANALYSER…………………………... 4
Section 2 INSTALLATION…………………………………………………... 7
2.1 Rear panel setting……………………...…………………………............ 7

2.2 Location of the instrument……………………………………….............. 8
2.3 Power supply connection…………………………………………........... 8
2.4 Caution…………………………………………………………….............. 10
2.5 Incubator……………………………………………………………........... 11
2.6 Printer settings………………..……………………………………........... 12
Section 3 MAIN MENU……………………………………………………… 13
Section 4 SETUP MENU……………………………………………………. 17
Section 5 ARCHIVES MANAGEMENT…………………………………… 24
5.1 Edit method………………………………………………………….......... 29

5.2 Edit Control…………………………………………………………........... 43
5.3 Graphic QC……………………………………………………….............. 44
5.4 Delete Archives……………………………………………………............ 49
5.5 Delete Archiv. Method……………………………………………............ 50
Section 6 OPERATING TIPS…………………………………………......... 51
6.1 How to aspirate the liquids into the flow cell……………………............ 51

6.2 Manual reading mode……………………………………………............. 52
6.3 Washing……………………………………………………………............ 54
6.4 Reset and switching off…………………………………………….......... 54
Section 7 RUN METHOD…………………………………………………… 55
7.1 Recall method………………………………………………………........... 55

7.2 Blank (Zero-setting)…………………………………………………........... 60
7.3 Production of Standards……………………………………………........... 61
7.4 Standard confirm procedure………………………………………........... 62
7.5 Sample measuring…………………………………………………............ 65
7.6 Flag Message…………………………………………………………........ 69
Section 8 ABS MENU……………………………………………………… 72
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Section 9 WASHING………………………………………………………. 73
Section 10 MAINTENANCE………………………………………………... 74
10.1 Cleaning procedures……………………………………………….......... 74

10.2 First installation……………………………………………………........... 74
10.3 Everyday cleaning ………………………………….………………........ 74
10.4 Special cleaning…………………………………………………….......... 74
10.5 Further advice……………………………………………………….......... 75
3
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
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- 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.
It performs:
- End Point
- Kinetic
- Fixed Time
- Multistandard assays
Results are shown by graphic display and printed on paper by built-in printer.
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Technical specifications
Graphic Display 320x240 (1/4 of VGA)

Patient name length 16 characters
Max test storage 1000 test
External interface - PS2 external keyboard (connection on rear side of
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.
- RS232
Two free positions for optional filters
Photometric 0-2.5 O.D.

Range: 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 Peltier elements 25°C, 30°C and 37°C.
controlvolume Flow cell: 500 L per test / Macrocuvette: 1000L per test
Reaction
Minimal 400 L
measurement
volume
Printer Graphic, 24 characters per line.
Printing sort Batch, profile, reaction dynamics, QC print, Levy Jennings
Dimensions Length 42 cm x width 38 cm x height 25 cm.
graph curves
Weight Kg 11
Power supply 110/220 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
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2 INSTALLATION
2.1 Rear panel setting
Located in the rear panel (from left to right as shown below) you will find:
1 Grid for internal cooling (a duplicate is located under the instrument).
2 The power supply switch.
3 The waste outlet.
4 RS232 connection
5 PS2 external standard keyboard connection
6 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

GRID
SWITCH AND FUSES PUMP OUTLET
7
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
- 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.
8
Labels:
For countries with 110/220 V AC voltage supply:
9
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.
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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.
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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
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3 MAIN MENU
1. Switch on: Start up the instrument from the main power switch located behind
the instrument.
2. 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.
3. 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:
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The main Master T functions are as following:
MESSAGE DESCRIPTION
Run method Displays the list of assays available for a

test.
To return to main menu press EXIT.
Archives management Enters in the memory management of

the instrument.
Press EXIT to return to main menu.
Set up Enters in the hardware and software

settings of the instrument.
Press EXIT to return to main menu.
Utility Absorbance reading: Press on this

message to enter in ABS test on sample
with programmable volume and filter
with zero option.
Host: Command to connect to dedicated
host PC software.
Exit: To return to main menu
Absorbance reading Enters in the ABS menu with

programmable volume and filter with
zero option.
To return to main menu press EXIT
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Printing Printing options.
It will be possible to print:
 patient test results
 patient profile report
 QC values
 List of test
 Test Parameters
Washing Activates the peristaltic pump for several

seconds for rinsing the flow cell with
cleaning solution or distilled water.
Time and Date: This window shows the time and date
memorized in the instrument.
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.
Temperature This window shows the current

temperature in the flow cell reading well
When this number is flashing it means

that the temperature has not reached
the target; in these cases wait until the
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indicator stop flashing.
Software release: This message shows the software

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

change.
Up and Down Arrows: Use the up and down arrows to move to

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.
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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: 25°C, 30°C,

37°C.
NOTE: If in the daily session there are

Temperature
some analyses with method
temperature at 30°C, it is
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
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precaution will ensure a perfect result).
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

To decide whether or not to print the
method (please refer to PRINT MENU
for information about printing format)
press:
enable or disable printing the method
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.
To decide whether or not to print the

patient result when running a test
method (the result can be printed at
Print result the end of work) press:
Enable or disable printing the result by

using the left and right arrows.
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 YES: to print the result.
 NO: not to print the result.
Press SAVE to store changes.
To decide whether or not to print

dynamics when running a test method
(for kinetic or fixed time) press:
Enable or disable printing the

dynamics by using the left and right
Graphic Print
arrows.
 YES: to print the dynamics.
 NO: not to print the dynamics.
Set the current hour using the number

Hour
keys
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
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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.
Delay time is defined in milliseconds.
This feature allows the operator to

prepare a sample test for a double
Gap Delay (m seconds)
check in 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

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
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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.
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For deciding whether or not to activate

the peristaltic pump after sample
measurement.
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.
Automatic Empty  NO: After sample

measurement, the 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. In order to empty the
flow cell, aspirate a new sample
or press Wash.
When the option NO is selected, none
sample concentration result will be
calculated for the analysis that present

Negative Abs*: absorbance values lower than reagent
blank.
When Negative Abs option is

activated, all samples absorbance
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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, then press SAVE
button.
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, then press SAVE button.
This option is active only when the
methods archive is locked by the
Master code*: distributor, please refer to distributor
for unlock procedure.
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Press this button to SAVE changes.

Save button:
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.
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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:
Press EXIT to return to main menu
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MESSAGE DESCRIPTION
Edit Method Edit the assay parameters settings of the

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

will be displayed.
Press the relevant assay to be edited or viewed.
Edit Control 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

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.
How to name a control:
1- Select the first free position, a virtual

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

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

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

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

virtual keyboard will appear.
2- Press Del
3- Press Save
Delete Archives In order to delete all the results and names resident
in memory for all tests, press this button.
Del Arch. Method Delete Archive Method: In order to delete all the
results resident in memory for a specific test, press
this button.
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.
Graphic QC 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.
To view a assay QC database, select the relevant

assay, a QC T will open showing the following:
1- Levey Jennings graph
2- Westgard Rules
3- Centred value
4- Mean
5- SD: Standard Deviation
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6- 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.
Edit Button: This button is present in every assay of the

Graphic QC menu.
Press Edit to view and edit a specific value of the

QC database.
Print button: 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:
------------------------------------
11/01/2005
015 - GLUCOSE
Date ABS Result
09/02 0.345 1 01.4
mg/dl 28
10/02 0.341 100.2

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
NOTE: Master T applications are loaded into the memory during System installation
and ready to use with Hospitex reagents.
NOTE: 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:
29
Choose Edit method, the list of assays present in memory will appear.
 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
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Select one method and the relevant parameters will appear as follow:
MESSAGE DESCRIPTION
Select this option and press virtual keyboard,

insert the Assay name than 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.
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
31
right arrows.
Flow cell temperature:
 25° C
 30° C
Temperature
 37° C

right arrows keys.
Calibration mode:
Different Ts will appear according to the

calibration mode:

right arrows.
FACTOR CALIBRATION:
1. Select: Calibration NO
2. Then press down arrow

Calibration
3. The Factor box will be displayed.
4. Insert the numeric value for the factor.

Use the number keys to enter the
numeric value, press C to delete.
STANDARD CALIBRATION:
1. Select: Calibration YES
2. Then press the down arrow
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3. The Factor box will be displayed.
4. Insert the number of standard by using

the left and right arrows ( From 1 to 9).
5. Then press the down arrow
6. 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 > =250 µl
Reagent 2 (µl) Insert the reagent 2 volume in microliters.
Select the method wavelength required; the

Filter different filters can be selected by using the left
and right arrows keys.
33
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
Min. ABS to detect problems of not active or too much
active reaction).
This value is important to evaluate reaction with
34
negative gradient.

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

Inc. Time 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
and fixed time. In fact the software provides a
Master T minimum incubation time of 10
seconds.
35
BS
Delay s
Reading
Incubation
time ec
time
n time
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.
36
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
right arrows.
NOTE: The QC 2 must be a different from the

QC 1
Digit the control serum centred value for this

Value QC 2 specific assay by using the side number
keyboard.
Digit the control serum 1 SD value for this

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

right arrows.
Digit the control serum centred value for this

Value QC 3 specific assay by using the touch keyboard.
Standard Dev. QC 3 Digit the control serum 1 SD value for this
37
specific assay by using the touch keyboard.
Keyboard: Press this button to recall the virtual keyboard

for the following:
 Name an Assay Method
Press this button to SAVE changes.

Save button:
Up and Down Arrows: Use the up and down arrows to move to

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.
38
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
5 Temperature * * * * 1= 25°C, 2=30°C, 3=37°C
6 Calibration * * * * Type of Calibration
STD Number of Standard (1 –

7 * * * *
Number 9)
STD Standard Concentration

8 concentration * * * * Value.
[max 9]
9 K Factor * * * * K Factor (Range 0.01-

99999)
10 Sample (μl) * * * * Sample Volume (Min 1 μl)
39
11 Reagent 1 * * * * Reagent Volume (Min>=

100 uL max 3000 uL)
Reagent Volume (Range
1- 1000uL)
12 Reagent 2 * * * *
R1+R2+S<=250 uL not
allowed
13 Filter 1 * * * *
Max normality
14 Normal Max * * * * concentration
(Range 0.001-99999)
Min normality
concentration
15 Normal Min * * * *
(Range 0.001-99999)
Linearity Max Concentration value

16 * *
Max
(Range 0.001-99999)
Maximum Initial ABS
17 Max ABS * * * *
2.5
Minimum Initial ABS

18 Min ABS * * * *
(0.001)
Maximum Delta ABS

19 Delta ABS * *
(0.001-2.5)
Incubation Time
20 Time Inc. * * * *
(Range 10-300)
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EP = Fixed
21 Time Read * * * KIN FXT = Reading time
(Range 10-300)
22 Name QC1 * * * * Select Qc name from list
23 Value QC1 * * * * Insert control value
Stand. Dev. Insert SD value

24 * * * *
QC1

27 * * * *
QC2

30 * * * *
QC3
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.
41
Create New Method:
1. Look for the first free position stated as “NEW METHOD” in the assay list using the
Up and Down arrow buttons.
2. Select and enter inside the method parameters
3. Name method and set assay parameters following assay producer specification
4. Save and Exit
Edit method:
1. Select end enter in the method to be edited
2. Make changes.
3. Save and Exit
Erase method:
1. Select end enter in the method to be deleted

2. Select N. Method line and press the virtual keyboard button
3. An edit screen for the name will open, press Del. Button and erase name.
4. Press save
5. Exit the method parameter
6. Confirm changes, the method will be erase and reported as “NEW METHOD” in the
list.
42
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.
43
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
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.
44
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 date.
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

defined for test.
L: QC result value is Lower than-2SD range
45
defined for test.
*: Excluded QC value.
In order to print all the QC values list for a

control serum, press this button
In order to print the Levy-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

calibrator menu
VALUE
MEAN The actual mean of the QC
The actual standard deviation of the QC

SD
The actual coefficient of variation of the QC
CV
data
46
The following table defines each column of the Westgards 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.
West Gards Rules abbreviation messages :

OK = The rule is satisfied
Other sign = The rule is not satisfied
No sign = The rule can not be applied. (On rule 5 at least 4 readings are needed and
on rule 6 at least 10)
47
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.
48
5.4 Delete Archives
From this menu, it is possible to delete all the patient data stored in the memory.
How to delete:
1. Press “Delete Archives”

2. A confirmation message will appear
3. Press YES to delete all the patient database results
4. 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.
49
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:
1. Press “Del. Arch. Method”
2. The list of tests will appear
3. Scroll (highlight) with the up and down arrows the method from the database that
must be deleted.
4. Press the Bin Button.
5. A confirmation message will appear
6. Press YES to delete all the patient database results
7. Press No to exit
50
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
ASPIRATION TIP and sample volume according
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.
51
6.2 Manual reading mode

To perform a measurement manually with a disposable cuvette, see the following
instruction:
1. Switch off the instrument.
2. Extract the flow cell from the reading well and leave it free inside the
measurement block
3. Switch on the instrument.
4. Now it is possible to read manually the Macrocuvette, insert the cuvette into
reading well.
5. To take measurement press the aspiration switch or touch the help window on
display.
6. Read the sample.
7. Repeat same operation for the following samples.
 If 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.
52
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
53
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
54
7 RUN METHOD
From Main screen select Run Method, the list of all tests present in memory will be
displayed.
7.1 Recall method
1. Use the Page Up and page Down buttons to scroll through the test list.
2. 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:
55
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,

Patient Name digit the patient name then press 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:
Id
The ID number is automatically set at 1 when
the first sample of the first assay is run for the
56
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

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.
Wash Press this button to activate the peristaltic
57
pump for 10 seconds.
This feature cleans the flow cell with distilled

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.
Next Visualizes the next free ID number.
Feed Press this button for paper feed.
The help bar has 2 different functions:
1-The bar displays a sequence of messages,

touch the message to initiate one order.
2- When the bar displays reading messages,

i.e. “”Insert blank”, “Insert Standard”, “Insert
sample” by touching it will start the reading
command.
Help Window
The help window bar is useful to:
1. Perform manual reading using disposable

cuvettes.
2. Repeat readings of same sample. In order

to do this it is necessary to disable from
setup menu automatic empty of
peristaltic pump.
58
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:
End Point and Fixed Time methods:
On axis of abscises reports concentration

value.
Reaction Graphical
On axis of ordinates reports the absorbance
Display
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.
59
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.
60
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 regent).
 Incubation and reading time.
The stored standards calibration factors are erased.
61
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.
Procedure:
Once a method is recalled from the list, it will ask for blank in the help window box as
follow:
CALIBRATING METHOD? YES/NO

1)
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
62
Press NO to skip to standard reading (point 4)
INSERT BLANK
3)
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
INSERT STANDARD
4)
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
Press NO to refuse last calibration procedure, the help window will ask the following:
REPEAT CALIBRATION? YES/NO
63
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.
64
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)
65
-The current sample order number.
-The absorbance value.
-The reading time evolution.
-The current working temperature of the flow cell.
-The graphic calibration point

-The result of the sample concentration at the end of the measurement, with a
supervisor control (see Flag messages)
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.
66
- 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.
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.
67
Test Patient repetition measurement
1. 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.
2. 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 cuvettes, it is not necessary to
disable the automatic waste function.
Processing QC controls
In order to insert in the QC database a control serum value for a specific assay proceed
as follow:
1. During the run session, it is possible to insert 3 control types (QC1 – QC2 – QC3)
for each method type.
2. To process a QC value, touch the ID box and the virtual keyboard will open.
68
3. Now it is possible to choose between 3 different QC (QC1 – QC2 – QC3) stated

in the keyboard keys.
4. Once the selection is done, the QC will appear automatically in the Nm patient
name box.
5. Once the QC reading measurement has been processed the result will be saved
in the database.
6. 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 Message
The following Message Flags might appear while performing sample assays in the RUN
menu and will print beside the concentration result:
MESSAGE DESCRIPTION
FLAG
Probable Cause
Patient result
Pathological evidence
value is higher
Corrective Action
H of normality
range defined Review the result and report as over

the normality high range value.
for test.
Dilute the sample and rerun.
69
Probable Cause
Patient result Pathological evidence
value is lower Corrective Action

L of normality
Review the result and report as under
range defined the normality low range value.
for test.
Concentrate sample and rerun.
Result concentration value > Max.

Conc. value defined for the test in Control
menu.
Probable Cause
Linearity high
D Sample concentration is greater than the
(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)
Linearity high Probable Cause
M Sample ABS value is greater than the

(Expressed in
Reaction Linearity Range defined on the
ABS value)
parameter page of the Method
Corrective Actions
70
ABS value < Max. ABS. value defined in

Control menu. (For Kin and FXT)
Probable Cause
Sample ABS value is less than the

Expressed Reaction linearity Range defined on the
m
in ABS value) parameters page of the Method
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
Reaction Max.Delta
Check for Delta

Probable Cause
Value
Sample concentration is greater than the
D (Expressed in Reaction Linearity Range defined on the
 ABS) is parameters page of the Method
outside the
range Corrective Actions
Target Not
The target temperature for reading well
Reached (37, 30°C ) has not been reached.
T
Probable Cause
The instrument is has just been switched
71
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
72
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.
73
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.
74
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.
75

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HOSPITEX INTERNATIONAL

HOSPITEX INTERNATIONAL S.R.L.

Section 1 DESCRIPTION OF THE ANALYSER…………………………... 4

2.1 Rear panel setting……………………...…………………………............ 7

Section 3 MAIN MENU……………………………………………………… 13

Section 4 SETUP MENU……………………………………………………. 17

Section 5 ARCHIVES MANAGEMENT…………………………………… 24

5.1 Edit method………………………………………………………….......... 29

Section 6 OPERATING TIPS…………………………………………......... 51

6.1 How to aspirate the liquids into the flow cell……………………............ 51

Section 7 RUN METHOD…………………………………………………… 55

7.1 Recall method………………………………………………………........... 55

Section 8 ABS MENU……………………………………………………… 72

10.1 Cleaning procedures……………………………………………….......... 74

1 DESCRIPTION OF THE ANALYSER

- Touch screen with virtual alphanumeric keyboard.

- Each test handles 3 different QC (quality control)

- 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.

Graphic Display 320x240 (1/4 of VGA)

Photometric 0-2.5 O.D.

Reading time 1-999 seconds

2.1 Rear panel setting

VOLTAGE PS2 RS 232

SELECTOR CONNECTION CONNECTION

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.

- Ensure that it is on a level surface.

- Avoid positions subject to jerks or vibrations.

5°C-50°C for instrument storage.

15°C-30°C for instrument use.

2.3 Power supply connection

For countries with 110/220 V AC voltage supply:

- Keep the instrument away from young children.

The incubator temperature is brought up to 37 °C by the software and it will remain

Constant until the instrument is turned off.

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:

Run method Displays the list of assays available for a

To return to main menu press EXIT.

Archives management Enters in the memory management of

Press EXIT to return to main menu.

Set up Enters in the hardware and software

Press EXIT to return to main menu.

Utility Absorbance reading: Press on this

Absorbance reading Enters in the ABS menu with

To return to main menu press EXIT

Printing Printing options.

It will be possible to print:

 patient test results

 patient profile report

To return to main menu press EXIT.

Washing Activates the peristaltic pump for several

The instrument is equipped with a back

Time and date can be set from Setup