652 1260 1 PB

STA-R Evolution Reference Manual
With Windows NT
(0931634-NT)
With Windows XP
(0931634)
REFERENCE
MANUAL
FOR ANY INFORMATION, PLEASE CALL

(NAME AND ADDRESS OF THE SUPPLIER):
Diagnostica Stago S.A.S - 9, rue des Frres Chausson - 92600 Asnires (France)
www.stago.fr- Contact: stago@stago.fr - RCS Nanterre - N B 305 151 409
80189
0931634-NT
Information contained in this document, in particular data, pictures, information, trademarks and logos are
protected by copyrights and other intellectual property rights 2007, Diagnostica Stago, all rights reserved 10-2007.
Consequently, all representation and/or reproduction, whether in part or in full, is forbidden and would be
considered a violation of Diagnostica Stagos copyrights and other intellectual property rights.
REFERENCE MANUAL
REVISION TABLE
Manual
Version
0931634-NT
Date
October 2007
Software Version
3.01
List of modifications
Creation
1-1
0931634-NT - October 2007
REFERENCE MANUAL
1-2
0931634-NT - October 2007
REFERENCE MANUAL
Content
Chap 1: Warnings and symbols

Chap 2: Introduction
Chap 3: Routine use
Chap 4: Maintenance
Chap 5: Detailed description of the software screens
Chap 6: Troubleshooting
1
0931634-NT - October 2007
Content
REFERENCE MANUAL
2
0931634-NT - October 2007
REFERENCE MANUAL
Content
Warnings and symbols
1.1
Meaning of the symbols used in STA-R Evolution . . . . . . . . . . . . . 1
1.2
General warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
1.3
Warnings regarding the use of biological products . . . . . . . . . . . . . . 2
1.4
Warnings regarding test settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
1.5
Bibliography - Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
1.6
Warnings regarding the use of access security . . . . . . . . . . . . . . . . . . 4
1.7
Warnings regarding the STA-R Evolution system . . . . . . . . . . . . . . 5
1.8
Warning regarding the analyzer disposal . . . . . . . . . . . . . . . . . . . . . . . 6
.................................... 1
1
0931634-NT - October 2007
Content
REFERENCE MANUAL
2
0931634-NT - October 2007
REFERENCE MANUAL
1 Warnings and symbols

1.1 Meaning of the symbols used in STA-R Evolution
On the analyzer
Alternating current
Direct current
Protection earth
Warning, consult the

accompanying documents
Off (turn current off)
On (turn power on)
Biohazardous element
Dangerous voltage
Medical equipment for in vitro

diagnosis
Name and address of

manufacturer
Do not turn by hand
Separate collection: do not

discard with other waste.
Product put on the market
after 13/08/20051
1 See chapter 1.8 for additional information about the disposal procedure.
Consumables
Use once only
Keep away from magnetic

fields
Disposable gloves mandatory
Mask and goggles must be

worn
Liquid that may be

contaminated biologically
Temperature limits for

preservation
In the documentation
Warning, important
information

Result of an action
Complementary information
"
Action to be performed
1-1
0931634-NT - October 2007
REFERENCE MANUAL
1.2 General warnings

The use of the STA-R Evolution system requires training provided either by Diagnostica Stago or
by one of its official distributors.
In order to ensure the correct operation of the STA-R Evolution system, it is imperative to
acknowledge and to comply with any and all of the analyzer, warnings, instructions and procedures
contained in this manual.
The compliance with any and all local legislations, regulations and norms related to biological acts
and/or to medical biology laboratories applicable in the territory where the STA-R Evolution system
is installed is required and in particular, for France, the GBEA (Guide to Correct Performance of
Medical Biology Analyses) published in its most recent version, the decree of April 26th 2002 (JO
[Journal Officiel] May 4ths 2002 n104), and for the United States, the CLIA-88 in the most recent
version (Clinical Laboratory Improvement Act of 1988).
All information, warnings, instructions and procedures contained in this manual and/or in all later
versions updated by Diagnostica Stago as well as all legislation, regulations and norms relating to the
use of medical in vitro diagnostic equipment in force and applicable for users locally (by locally, we
understand the territory in which the STA-R Evolution system is installed) are hereinafter
collectively referred to as the Recommendations.
Under no circumstances Diagnostica Stago, its employees, its suppliers or a third party mentioned in
this manual shall be liable whether in contract, tort including, but not limited to negligence or
otherwise for any special or consequential damages, damages or losses that result from the security
and the efficacy of the STA-R Evolution system as well as any damage whatever, direct, indirect,
material or immaterial, incidental or accessory, or of any nature whatever or of any prejudice, in the
non restrictive cases listed hereunder:
(i) in case of non respect of the recommendations described in this manual as well as the use of
procedures that are not set forth by Diagnostica Stago,
(ii) in case of use of reagents other than those manufactured by Diagnostica Stago even if the use of
said reagents associated with the STA-R Evolution system is specified in an adaptation protocol,
(iii) in case of use of tubes other than those specifically listed in chapter 2 of this manual,
(iv) in case of use of washed and/or re-used cuvettes, the reacting cuvettes being consumables
intended for a single use, as well as cuvettes other than those manufactured by Diagnostica Stago and
commercialised by Diagnostica Stago and/or by its official distributors,
(v) in case of non accomplishment of the current and regular maintenance operations, calibration and
support operations set forth in the present manual and permanently required to ensure the correct
functionning and security of the STA-R Evolution system,
(vi) in case the STA-R Evolution system is not decontaminated in accordance with the
decontamination procedures set forth in chapter 4.9.1 of this manual.
1.3 Warnings regarding the use of biological products

For how to handle reagents, calibrator plasmas, control plasmas, and patients plasmas (hereinafter
referred to as Products), carefully read the notes that come with each Product.
Prior to any intervention in the STA-R Evolution system, to ensure that the personnel working in
contact with biological products are protected, and to allow a proper execution of the biological
assays, please comply with the following measures:
1-2
0931634-NT - October 2007
REFERENCE MANUAL
(i) respect all recommendations,

(ii) be sure to decontaminate the STA-R Evolution in accordance with the procedures identified in
this manual (see chapter 4.9.1),
(iii) respect all norms and safety measures imposed on laboratories for performance of biological
analyses connected with biohazardous Products in accordance with the regulations in force locally.
For example, the following precautions should be taken:
-
Do not eat, drink or smoke on the premises where these Products are handled,
Consult a doctor immediately if these Products are ingested or put into contact with mucous
membranes or skin lesions (wounds, cuts, etc.),
Use disposable gloves and handle all these Products as a potential source of infection,
Dispose of all these Products as if they were infected, in accordance with the legislation and the
regulations in force locally (for example: autoclaving, incineration of disposable material,
elimination of liquid waste, see the card ref. 0931066x "Liquid waste management" or local
regulations in force).
1.4 Warnings regarding test settings

Not following the conditions connected with the test configurations may have
consequences on the reliability of the results, as well as on performance of any biological
analysis using the STA-R Evolution system, therefore the following conditions should be
observed:
-
Pre-analysic conditions regarding samples: to maintain the activity of various coagulation

factors, the sample should be taken with care and following the professional standards in tubes
with a specified concentration of citrate.
You should next make sure of centrifuging quality then sample preservation temperature prior to
sample analysis:
- hemolized and partially coagulated plasma (presence of micro-clots), plasma that was damaged
by temperature changes or plasma with bubbles on its surface may cause inaccurate results.
- plasma that has been congealed may, on thawing, contain sediments that must be removed
before any measurement is performed.
Pre-analytic conditions regarding products and reagents: the laboratory must strictly
comply with the instructions provided by the manufacturer in the inserts of the products and
reagents. Poor preparation of the reagent as regards reconstitution volume, stabilization time,
stirring, the presence of bubbles, forgetting or inappropriately leaving in a magnetic stir bar may
lead to incorrect results.
The ISI value of the thromboplastin used for the determination of the prothrombin time should
be the one indicated on the assay value insert. Any change in lot, any software update - like any
intervention - should give rise to verification of the ISI value.
Configuration and condition of the analyzer: the laboratory must take care that the test
configuration complies with the manufacturers prescriptions for reagents, in particular for the
volumes used, the incubation times, the rinsing solutions, the buffers, etc. It is the laboratory's
responsibility to correctly enter the bar codes and to choose the appropriate test configuration
for a given test. The laboratory must make sure that the analyzer is regularly maintained,
according to the recommendations given in this manual.
In addition, the analyzer gives results from biological material and although this material is used
and measured by highly sophisticated computer-controlled automated systems in order to
optimize the reliability and security, it is impossible to guarantee an error rate of zero.
For example, studies carried out on the prothrombin rate have demonstrated that when the preanalytic conditions are respected, the inconsistency rate (difference between two results
> 15 %) on duplicate tests is less than one in ten thousand. This rate may be compared with the
1-3
0931634-NT - October 2007
REFERENCE MANUAL
error rate likely to be observed for tests in single determination. It should be noted that below
one in ten thousand, it is difficult to qualify an error rate experimentally and precisely. This
inconsistency rate is given as an indication ; it may vary according to the test/assay, sample volume,
dilution...
This data indicates that if duplicate tests are carried out on the same sample, the error rate is
mathematically of the order of one in one hundred million, which although not zero can be
considered as negligible.
Lastly, the results produced by the analyzer must always be analyzed according to the patients
history, the clinical examination and any other biological results.
-
Conditions regarding the validation of methods and techniques: the test configurations
provided by Diagnostica Stago have been validated individually for the
STA-R Evolution analyzer and the possible interactions between the reagents have also been
evaluated. Each laboratory must, considering the regulations applicable in each country, the
specificities and the population of the laboratory patients and the nature of each test, select and
validate the test method used. If the laboratory decides to use other lines of reagents and
methodologies that have not been validated by Diagnostica Stago as useable with the STA-R
Evolution analyzer, a validation of this new system will be necessary. This validation will ensure
that the characteristics of the method are verified on the one hand (see references, 2nd
reference) and that any possible interactions between the new and the old products are checked
on the other hand.
1.5 Bibliography - Warnings

-
KOEPKE J. A., McLAREN C. E., WIJETUNGA A. AND HOUWEN B.:

"A Method To Examine the Need for Duplicate Testing of Common Coagulation Tests".
Am. J. Clin. Pathol., 102, 2, 242-246, 1994.
VASSAULT A. et al.:
"Protocole de validation de techniques" (Protocol for validation of techniques).
Ann. Biol. Clin., 44, 686 - 745, 1985.
1.6 Warnings regarding the use of access security

The various functions of STA-R Evolution may be classed into 2 levels:
-
Routine functions (example: launching analyses, loading products),
Modification functions (example: creation or modification of test configurations).
For all these functions, security levels can be defined.

The use of routine functions has no incidence on the results obtained. On the other hand, the use of
modification functions may have consequences on the reliability of the results.
For this reason, it is mandatory for each laboratory to evaluate the consequences of using various
functions before assigning security access.
1-4
0931634-NT - October 2007
REFERENCE MANUAL
1.7 Warnings regarding the STA-R Evolution system

Contextual help is a service provided by the software installed on the STA-R Evolution, protected
by Diagnostica Stago copyrights that facilitate use of STA-R Evolution. Nonetheless, to ensure the
security and efficacy of the STA-R Evolution system, it is absolutely necessary for the user to be
familiarized with all warnings, procedures, recommendations contained in the Reference Manual in
the latest updated version.
The STA-R Evolution may only be installed by a technician duly authorized either by Diagnostica
Stago or by one of its official distributors.
To avoid any risk of electrical shock, it is absolutely necessary to follow the procedures described in
this documentation precisely (STA-R Evolution online help or reference manual).
The STA-R Evolutionwas made and tested according to the CISPR 11 (International Special
Commitee On Radio Interference) for class A equipment. In a domestic environment, it may cause
radio interferences, in which case, measures will have to be taken to reduce these interferences.
The analyzer conforms to the EN 61326-2-6-2006 standard.
The electromagnetic environment should be evaluated before using the analyzer.
Keep away from the analyzer all sources of high electromagnetic radiation (cellular phones,
unprotected sources of radio frequency...) as they may interfere with the operating conditions of the
analyzer.
For security reasons, the front panel of STA-R Evolution and the access cover to the rack conveyor
should be kept closed. If these parts are open, the STA-R Evolution will detect their absence and
will immediately stop the analyses in progress. Do not attempt to defeat the operation of the
switches that detect the presence of the front panel and the rack conveyor access cover.
It is absolutely necessary to check that all covers, covers and drawers of the STA-R Evolution (listed
below) are closed before power is turned on. During operation, it is absolutely necessary to close
them as soon as any handling requiring them to be opened is finished.
-
upper left side cover
lower left side cover
upper right side cover
lower right side cover
front cover
access cover for the tube turning wheel
transparent cover
products drawer
If it is necessary to come near the analyzer to observe the stage in tube loading inside the analyzer
or the progress of an analysis, make sure that you wear disposable gloves, goggles and a face mask.
For security reasons, the operator should completely close the front panel of the STA-R Evolution
himself/herself.
To prevent damage to the monitor touch screen panel, do not use any sharp object to point to an
element on the screen.
The expiry dates and lot numbers of the following products are not controlled by the analyzer:
-
STA-OWREN KOLLER dilution buffer,
1-5
0931634-NT - October 2007

-
STA-Desorb U solution,
STA-CaCl2 reagent.
REFERENCE MANUAL
Therefore, the user must check the expiry date of these products before loading them in the
analyzer.
For these products, only the stability and the volume are controlled by the analyzer.
The stability of the reagents which were unloaded and then reloaded is not controlled by the analyzer
and remains on the entire responsibility of the user.
1.8 Warning regarding the analyzer disposal

Waste Electrical and Electronic Equipment (WEEE).
The use of this symbol implies that the analyzer must not be disposed of with
household waste; that it must be subject to separate collection and that it has been put
on the market after 13 August 2005.
For more information about the appropriate disposal of the analyzer (in countries other than France),
contact the local distributor.
1-6
0931634-NT - October 2007
REFERENCE MANUAL
Content
Introduction
2.1
Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
2.1.1
Installation requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
2.1.2
Installation procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
2.1.3
Setting date and time . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
2.1.4
Connecting peripheral devices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
2.2
Presentation of the analyzer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
2.2.1
Purpose of the analyzer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
2.2.2
General description of the analyzer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
2.2.3
Description of the measuring system in chronometry . . . . . . . . . . . . . . . . . . 6
2.2.4
Description of the measuring system in photometry . . . . . . . . . . . . . . . . . . . 7
2.2.5
Description of steps in analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
2.2.6
Description of sample loading . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
2.2.7
Description of product loading . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
2.2.8
Description of the incubation block-measurement . . . . . . . . . . . . . . . . . . . 11
2.2.9
Description of the cuvette movement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
2.2.10
Description of the distribution of plasmas and products . . . . . . . . . . . . . . . 12
2.3
Technical specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
2.3.1
STA-R Evolution technical specifications Part 1 . . . . . . . . . . . . . . . . . . . 12
2.3.2
2.3.3
2.3.4
.............................................. 1
1
0931634-NT - October 2007
Content
REFERENCE MANUAL
2
0931634-NT - October 2007
REFERENCE MANUAL
Introduction
2 Introduction
2.1 Installation
2.1.1 Installation requirements
Space to be reserved for the system
-
Height: 1875mm (73,8 in.).
Width: 2940mm (115,7 in..).
Depth: 1300mm (51,2 in.).
Electrical power supply

-
Voltage and tolerances: 230V (10%), 210V (10%), 115V (10%), 100V (10%).
Frequency and tolerance: 50/60Hz.
Power: 2kW.
2.1.2 Installation procedure

The STA-R Evolution may only be installed by a representative duly authorized either by
Diagnostica Stago or by one of its official distributors. Likewise, if the STA-R Evolution needs to be
moved, this must be done by a representative of Diagnostica Stago, or by one its official distributors
who has the equipment necessary to handle the analyzer.
2.1.3 Setting date and time

" From the desktop, right click the clock located on the task bar in the corner of the screen then
click Adjust date/time.
The Date/Time Properties dialog box appears.
" Click the Time Zone tab.
2-1
0931634-NT - October 2007
Introduction
REFERENCE MANUAL
" From the pull-down menu (mark 1 in the figure above), select the required geographical zone.
" Select "Automatically adjust clock for daylight saving changes" (mark 2).
" Click the Date & Time tab.
" Select the month (mark 1), the year (mark 2) and the hour (mark 3).
" Click
2.1.4 Connecting peripheral devices

The various external peripheral devices are connected to the back and the bottom of the analyzer.
2-2
0931634-NT - October 2007
REFERENCE MANUAL
Introduction
Turn the STA-R Evolution off before connecting:

- the screen,
-
the printer,
the serial port used to connect a modem,
the Touchpad: tactile keyboard pad,
the tactile part of the screen,
the keyboard,
the serial port used to connect to the server.
2-3
0931634-NT - October 2007
Introduction
REFERENCE MANUAL
Representation of external connections.

Connection for:
Mark
Element to be connected
VGA tactile 15" minimum screen
Parallel port for printer

Do not remove the element (dungle)
connected to the port. Connect the printer to the dungle.
Serial port (modem connection)
"Touchpad": tactile keyboard pad
Tactile part of the screen
Keyboard
Serial port
(connection to server)
Pictogram
2.2 Presentation of the analyzer

2.2.1 Purpose of the analyzer
The STA-R Evolution system is a piece of medical equipment for in vitro diagnostic use that
comprises a laboratory analyzer and software designed to be used together with consumables and
reagent products. The STA-R Evolution system has been designed to perform in vitro tests for
diagnosis and monitoring of pathologies related to hemostasis.
It is possible to perform chronometric tests (measurement of coagulation time), colorimetric tests
or immunological tests on plasma samples.
2-4
0931634-NT - October 2007
REFERENCE MANUAL
Introduction
2.2.2 General description of the analyzer
Upper left side door:

Syringes for arms 1, 2 and 3 (see chap. 4.5.1 of this manual)
Rack panel / loading zone:

- Loading / Unloading of samples (see chap. 3.6 of this manual)
- Loading a Stat rack (see chap. 3.6.7 of this manual)
Access cover to the tube rotating wheel

- Bar code scanner for samples (see chap. 3.6.2 of this manual)
- Tube rotating wheel (see chap. 4.7.4 of this manual)
Lower left side door

- Diskette drive
- CD ROM drive or CD/DVD recorder
- Data backup and exportation (see chap. 4.10.2 of this manual)
- Changing secondary fuses (see chap. 4.8.5 of this manual)
Main air filter
Transparent cover
- Cleaning needles 1, 2 and 3 (see chap. 4.4.2 of this manual)
- Cleaning the rinsing well (see chap. 4.4.2 of this manual)
- Cleaning the measurement plate (see chap. 4.4.7 of this manual)
- Cleaning the suction tip (see chap. 4.4.8 of this manual)
- Cleaning the shuttles (see chap. 4.4.10 of this manual)
Upper right side door

- Loading the cuvette reel (see chap. 3.3.1 of this manual)
- Cleaning the conveyor belt (shuttle transporter) (see chap. 4.4.9 of this manual)
2-5
0931634-NT - October 2007
Introduction
REFERENCE MANUAL
- Changing the grip filter (see chap. 6.5.4 of this manual)

- Condensation trap (see chap. 4.3.1 of this manual)
- Cuvette loader (see chap. 4.7.3 of this manual)
Product bar code reader

- Reading bar code labels for products (see chap. 3.4.3 of this manual)
Products drawer
10 Front door
- Loading of cleaning solution (see chap. 3.3.3 of this manual)
- Changing liquid waste bottle
- Loading the cuvette waste bin (see chap. 3.3.2 of this manual)
11 Lower right side door

- Optic Module Halogen lamp (see chap. 4.8.3 of this manual)
- Optic Module air filter (see chap. 4.6.1 of this manual)
- On/off switch (see chap. 3.2.1 of this manual)
- Main fuses (see chap. 4.8.4 of this manual)
2.2.3 Description of the measuring system in chronometry

The principle consists of measuring the variation in amplitude of the balls oscillation. A reduction in
amplitude corresponds to an increase in the mediums viscosity, in other words, in the coagulation
phenomenon.
At constant viscosity, you obtain a constant pendulum-like swinging movement of the ball thanks to
two rails curving inwards on the bottom of the cuvette and in the electromagnetic field created
alternatively on each side of the measuring head to maintain this swinging movement. The frequency
of this field is close to the proper frequency of the balls oscillation, which ensures a good level of
sensitivity in the system.
For each measurement head, the magnetic field is created by two motor coils and automatically
adjusted by the software as a function of the mediums viscosity and of the type of clot being tested
for (weak clot for Fibrinogen, normal clot for all the others).
The measurement heads include an emitting coil and a receiving coil.
Receiver coil
Transmitting coil
2-6
0931634-NT - October 2007
REFERENCE MANUAL
Drive coil
Ball
Cuvette
Introduction
At constant viscosity, the amplitude of the balls oscillation is constant. When the viscosity increases
(the phenomenon of coagulation), the amplitude of the balls oscillation decreases. An algorithm uses
this variation in amplitude to determine coagulation time.
2.2.4 Description of the measuring system in photometry

The detection principle in the colorimetric or immunological tests on STA-R Evolution is based on
the absorbance (optical density, O.D.) of monochromatic light (405 nm or 540 nm) passing through
a cuvette at the time when a chromogenic reaction takes place.
The principle behind measurement of absorbance is presented in the figure below. Incident light (I0)
that penetrates the cuvette is partly absorbed by the reagent medium.
Transmitted light (I1 = I0 +Ip) is measured and converted into absorbance by the following equation:
A = Log (I1/I0)
Note: Decimal logarithm
Ambient light (Ip) is eliminated by taking 2 measurements of transmitted light within a brief interval:
2-7
0931634-NT - October 2007
REFERENCE MANUAL
Introduction
I1 = I0 + Ip (first measurement with incident and ambient light),

I2 = Ip (second measurement by blocking incident light, corresponds to ambient light).
Then by subtracting I2 from I1, we obtain I0 that corresponds to light resulting only from incident
light. We suppose that ambient light (Ip) remains identical between 2 measurements.
The source of monochromatic incident light (I0) is obtained from a tungsten halogen lamp and from
a filter (405 nm or 540 nm) placed in a moveable filter holder.
These various parts are found in the optic module. From the optic module, the monochromatic light
is directed to the measurement heads by fiber optics, then from the measurement heads to the
analog measurement card through other fiber optics, see figure below.
I0 (incident light) is known thanks to the reference fiber (the fiber that goes directly from the optic
module to the analog measurement card).
Measurement head
RS232
Reference fiber
PC
Sensor
9-Optical fiber harness
Analog measurement board
Photometry module with switch-over

filters
CPU measurement board
From the measurements of optical density that are obtained, the Beer-Lambert law is applied, that is:
2-8
0931634-NT - October 2007
REFERENCE MANUAL
Introduction
A = IC
where:
A
absorbance
coefficient of molecular extinction
length of the optical trajectory
concentration
The concentration of the chromogen sought is directly proportional to absorbance.

Note: All measurements of optical density are done in relation to the reference fiber.
2.2.5 Description of steps in analysis

The plasma (sample, control or calibrator) is pipetted by needle n1 with or without diluting agent
then distributed in a cuvette (shuttle with cuvette is stopped at the sample stop).
If intermediate reagents are required, the feed is stopped at the reagent stop and these are added to
the cuvette by needle n2. The shuttle is then stopped at the measurement stop for the arm equipped
with suction cups to transfer the cuvette to the incubation zone.
A few seconds before the incubation time elapses, the cuvette is moved to the measuring area by the
arm with the suction cups. The reagents to be distributed after the first incubation (principally the
start reagent) are pipetted by needle n3. When preheating the reagents to 37C is required, the
reagents are maintained for about 2 seconds in needle n3's heating tube. Then, with or without
preheating, the reagents are distributed in the corresponding cuvette in the measuring area. As soon
as measuring is finished, the suction cup arm takes the cuvette and disposes it in the cuvette waste
bin.
2.2.6 Description of sample loading

The primary tubes are loaded onto racks of 5 tubes after centrifugation. They are then put into a tray.
This is put into the loading/unloading area of the STA-R Evolution.
The STA-R Evolutions software detects the presence of the basket of racks and proceeds to load
its contents. Each rack moves in front of the sample bar code reader.
2-9
0931634-NT - October 2007
Introduction
REFERENCE MANUAL
The bar code label identifying the rack is read. A wheel then rotates the tubes in front of the bar code
scanner until the label is scanned. Available only if you use Diagnostica Stago racks and the Stago
reading mode.
Thanks to the scanning of the rack and tube identifications, the system is able to know the location
of any tube in the analyzer. The racks then move into the pipetting area.
There is an area where the samples can be pipetted immediately (zone A with 28 racks) and a storage
area where the samples can not be directly pipetted.
2-10
0931634-NT - October 2007
REFERENCE MANUAL
Introduction
2.2.7 Description of product loading

All products required to carry out analysis are to be loaded into the product drawer. An area is
reserved for each type of product.
Area
Type of products
Blue (Left)
(R0)
Calibrators,
Controls,
Diluents,
Decontaminating solution.
White (Center)
(R1)
Reagents to be distributed before the first incubation,
Blue (Right)
(R2)
Reagents to be distributed after the first incubation (mainly start

reagents)
In the center and right areas, some positions are equipped with a stirring motor for use with a
magnetic stir bar.
These are identified by the symbol
Before loading, each product vial is identified (bar code label reader). The vials are then loaded, their
position is automatically recognized by the Positive Identification system.
The temperature of the products is maintained between + 15C and + 19C by an air conditioning
system (circulation of cool air).
2.2.8 Description of the incubation block-measurement

The incubation area and the measurement area are part of the same block, which is maintained at
37C 0.5C by a system based on a laminar resistor.
2.2.9 Description of the cuvette movement

The reaction/measurement cuvettes are loaded on to the STA-R Evolution in the form of a reel of
1000 cuvettes. They are distributed one by one into cuvette shuttles by a double belt conveyor. On
the conveyor belt, the cuvette shuttles can be immobilized at stop stations for distribution of plasma
or reagents, to be transferred to an incubation area or for shuttle loading.
2-11
0931634-NT - October 2007
Introduction
REFERENCE MANUAL
2.2.10 Description of the distribution of plasmas and products

A needle is reserved for each type of product.
Needle
Products
N1
Sample plasmas (racks of 5 tubes)
Control plasmas and calibrator plasmas (left part of the products drawer)
N2
Reagents to be distributed before the first incubation (central area in the

product drawer)
N3
Reagents to be distributed before the first incubation (right part of the

product drawer)
A system to detect the level of liquid is associated with each needle.

Between each distribution/sampling, each needle is rinsed inside and outside in its rinsing well, which
eliminates possible contamination.
2.3 Technical specifications

2.3.1 STA-R Evolution technical specifications Part 1
STA-R Evolution system is exclusively made of the instrument, its screen and its keyboard and
must be used inside.
Type:
-
In vitro diagnosis analyzer
Multi-parameter analyzer
Functions patient by patient
Conditions of use:
-
Temperature: +15C at +32C (59F to 89.5F).
Humidity: 20 to 80%.
Altitude: <2000 m.
Intensity of incident light on the open drawer.
Storage and transport:

-
Shock resistance: according to the norms in force.
2-12
0931634-NT - October 2007
REFERENCE MANUAL
Temperature: -20C at +60C (-4F to +140F).
Relative humidity: 20 to 80%.
Dimensions of the crated analyzer:

Height: 1,460 mm
Width: 1,460 mm
Depth: 960 mm
Weight of the crated analyzer: 374 kg
Non stackable storage.
Introduction
Environment:
-
Maximum volume level: 55 dB.
Heat generated at an ambient temperature of 20C:

- 220 V Version ~: 6824 BTU/h,
Dimensions of the analyzer:

-
Height: 1250mm (49,2 in.).
Width: 1280mm (50,3 in.).
Depth: 820mm (32,3 in.).
Weight of the analyzer:

-
256kg (564 lb)
Space to be reserved for the system:

-
Height: 1875mm (73,8 in.).
Width: 2940mm (115,7 in.).
Depth: 1300mm (51,1 in.).
Electrical power supply:

-
Voltage: and tolerances: 230V ~ (10%), 210V ~ (10%), 115V ~ (10%), 100V ~ (10%).
Frequency: and tolerance: 50/60Hz (47 to 65Hz).
Power:
- 2kW (for 210 V ~ / 230 ~)
- 1.8 kW (for 100 V ~ / 115 V ~)
- maximum 2.5 kW (peak value)
Number of outlets: 3 (1 for the STA-R Evolution, 1 for the screen and 1 for the printer): 1 earth
and 2 poles, 16 A
Protection fuses: yes.
Need of surge protection for micro-cuts: no.
Effects of a distinct cut-off: lost tests in progress, possibility of change in hard disk.
Possible extensions:
-
Cap piercing option
Line Automation connection option

Standards:
2-13
0931634-NT - October 2007
Introduction
REFERENCE MANUAL
For STA-R Evolution 230 V:

- CE marking (98/79/CE directive)
- EN 61326-2-6 (Class A for emissions and industrial immunity)
- EN 61010-1 and EN 61010-2-101

- UL marking
- FCC Part 15
- UL 61010 A-1 (Underwriters laboratory)

- CEI 61326 (Class A for emissions and industrial immunity)
- CEI 61010-1 and CEI 61010-2-101
Classification:
-
Type of protection against electrical shock: Class I device
Degree of protections against water penetration: ordinary device (device under wrap without
protection against water penetration).
Degree of protection against electrical shock: Type B device.
Degree of security of use: device not adapted for use in the presence of a flammable anesthetic
mixture with air, oxygen or nitrogen protoxide.
Degree of pollution: 2
Recommended disinfection method: see procedure in chapter 4.9.1 of this manual.
Mode of operation: continuous service.
Note: All devices connected to the STA-R Evolution should comply with the CEI 60950 and/or EN
55022 class B norms.

Sample management:
-
Primary centrifuged tubes with or without bar code (uncapped tubes) with:
- 11mm (0.43 in.) diameter for a 3ml tube,
- 11.6 to 13.4mm (0.46 to 0.53 in.) diameter for a 5ml tube,
- length of 65 to100mm (2.56 to 3.94 in.).
BD Vacutainer pediatric tubes 10 mm diameter and 47 mm or 64 mm high.
List of recommended tubes for capped tubes, see the list in the 0931208x document "Cap
piercing option: list of tubes".
Rack of 5 tubes.
Tray of 15 racks.
Capacity of 43 racks in the analyzer: 28 in pipette ready position right away and 15 in the storage
area.
Positive Identification and bar code reader.
Automatic dilutions.
Product management:
2-14
0931634-NT - October 2007
REFERENCE MANUAL
Introduction
1 drawer divided into 3 areas:

R0:1 area for controls, calibrators and diluting agents,
R1: 1 area for reagents to be distributed before the first incubation,
R2:1 area for reagents to be distributed after the first incubation,
2-15
0931634-NT - October 2007
REFERENCE MANUAL
Introduction
R0 Area:
Previous version
Current version
positions for 4ml vials ( 18.6 mm)
18
16
positions for 15/20 ml vials ( 30.7mm)
No stirring positions
R1 Area:
Previous version
Current version
of which x positions equipped with magnetic

stirrers
positions for 6 ml vials ( 22.7 mm)
11
10

stirrers
15
15
Previous version
Current version

stirrers
12
10

stirrers
R2 Area:
Identification by bar code reader
Air conditioned zone (15C to 19C)
Management of the stability and the volume of the products
Note: Products = controls, calibrators, reagents, diluents, decontaminating solution.

Bar code reader:
-
Maximum peak power: 4.6 mW
Pulse of 1 ms at 100 Hz
Standard CEI 60825-1: Class 1M
2-16
0931634-NT - October 2007
REFERENCE MANUAL
Introduction
Measurement principle:
-
Modes of analysis: chronometry and photometry.
Chronometry: modification in viscosity of the medium, detection by electromagnetic sensors.
Photometry: measurement of optical density to 405nm and to 540nm.

- colorimetry
- turbidimetry (immunology)
Pipettors:
-
3 250l syringes.
Cuvettes:
-
In the form of rolls of 1000 cuvettes with integrated stainless steel balls.
Management of the roll tracking: identification by bar code.
Authorizing a pendulum movement of the ball (STAGO patent).

Patent N:
- FR 8718348
- FR 8809151
- US 4918984
- JP 1939942
- EP 0325874
Maximum useable volume: 400l.
Minimum volume: 150l in chronometry and 250l in photometry.
Performance:
-
Intra-trial repeatability using Diagnostica STAGO products
Normal plasmas
Pathological plasmas
PT (sec)
< 1,5 %
<2%
APTT (sec)
< 1,5 %
<2%
Fib. (sec)
<4%
<5%
Inter-sample repeatability using Diagnostica STAGO products:
Normal plasmas
PT (sec)
<3%
<3%
APTT (sec)
<3%
<3%
Fib. (sec)
<4%
<5%
2-17
0931634-NT - October 2007
Introduction
REFERENCE MANUAL

PC integrated (minimum characteristics):
-
Microprocessor: Pentium MMX (200MHz minimum)
Random Access Memory: 64Mb
Hard disk: evolving (2.4Gb Min.)
Diskettes: 1,44Mb
CD ROM drive or CD/DVD recorder
Writable disks: CD-R, CD-RW, DVD (only if there is the analyzer is equipped with a CD/DVD
recorder)
9 micro-controlers
Operating system: Windows NT 4.0 or
Computer connection:
-
ASTM protocol
Output from STA-R Evolution, SUB-D 9 connecting pins
Screen:
-
CRT = VGA color minimum 15 tactile (resistant) ferrite on power supply cable
or TFT = 17 with tactile surface
Keyboard:
-
Alphanumeric with pointer keys
2-18
0931634-NT - October 2007
REFERENCE MANUAL
Content
Routine use
3.1
Meaning of icons and symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
3.1.1
Meaning of symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
3.1.2
Meaning of the icons . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
3.2
Analyzer preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
3.2.1
Turning the analyzer on . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
3.3
Loading/unloading consumables . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
3.3.1
Change the cuvette roll using bar code identification . . . . . . . . . . . . . . . . . . 8
3.3.2
Change the cuvette disposal bag . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
3.3.3
Loading the cleaner solution . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
3.4
Loading/unloading the products . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
3.4.1
Warnings related to loading products . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
3.4.2
Open the Products drawer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
3.4.3
Loading a product with bar code identification . . . . . . . . . . . . . . . . . . . . . . 16
3.4.4
Loading a product using manual identification . . . . . . . . . . . . . . . . . . . . . . . 18
3.4.5
Loading a product without positive identification of the positions . . . . . . . . 19
3.4.6
Unloading the products using positive identification . . . . . . . . . . . . . . . . . . 20
3.4.7
Unloading the products without positive identification . . . . . . . . . . . . . . . . 20
3.4.8
Close the Products drawer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
3.4.9
Enter the bar code information manually . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
3.4.10
Sorting products - Product list screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
3.4.11
Sorting products Forcecast Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
3.5
Quality control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
3.5.1
Running a quality control manually . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
3.5.2
Validating a quality control result . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
3.5.3
Deleting a quality control result . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
3.5.4
Display the days controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
............................................... 1
1
0931634-NT - October 2007
Content
REFERENCE MANUAL
3.5.5
Displaying the last quality control result . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
3.5.6
Printing the days controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
3.5.7
Displaying and printing the quality controls for a given period . . . . . . . . . . 28
3.5.8
Printing a quality control in graphical mode . . . . . . . . . . . . . . . . . . . . . . . . . 29
3.5.9
Changing the values of the thresholds for a quality control . . . . . . . . . . . . . 31
3.5.10
Transmitting a control result . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
3.5.11
Deleting all quality control results for a level . . . . . . . . . . . . . . . . . . . . . . . . 31
3.6
Loading/unloading the samples . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
3.6.1
Loading a Patient tube . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
3.6.2
Loading a rack of tubes / automatic identification mode Case n1 . . . . . . 34
3.6.3
3.6.4
3.6.5
3.6.6
Loading a rack of tubes / manual identification mode Case n5 . . . . . . . . 38
3.6.7
Urgent (STAT) loading of a rack of tubes / manual identification mode Case n6

40
3.6.8
Urgent (STAT) loading of a rack of tubes / automatic identification mode Case n7

41
3.6.9
Tagging racks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
3.6.10
Tagging all racks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
3.6.11
Removing the tag from all the racks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
3.6.12
Removing the tag from some racks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
3.6.13
Sorting the racks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
3.6.14
Printing the list of racks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44
3.6.15
Unloading a rack . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44
3.6.16
Unloading several racks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45
3.6.17
Unloading all the racks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45
3.6.18
Reloading a rack after the unloading of a tube . . . . . . . . . . . . . . . . . . . . . . . 46
3.6.19
Release the tray . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
3.7
Processing patient files . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48
3.7.1
Tagging patient files . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48
3.7.2
Adding a test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50
2
0931634-NT - October 2007
REFERENCE MANUAL
Content
3.7.3
Blocking/unblocking tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53
3.7.4
Rerunning a test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56
3.7.5
Deleting a test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57
3.7.6
Validating the results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59
3.7.7
Viewing a result . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61
3.7.8
Transmitting results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62
3.7.9
Moving a sample that has already been loaded to STAT sample . . . . . . . . . 65
3.7.10
Looking for a patient file . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65
3.7.11
Printing patient files . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 66
3.7.12
Changing the display of the test panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68
3.7.13
Adding a note to a patient file . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 70
3.8
Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 70
3.8.1
Running a calibration Calibration screen . . . . . . . . . . . . . . . . . . . . . . . . . . 70
3.8.2
Automatic calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 71
3.8.3
Changing a calibration point . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 73
3.8.4
Changing the100% point . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 74
3.8.5
Rerunning a calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 74
3.8.6
Rerunning a calibration point . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 74
3.8.7
Resuming an initial calibration point . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75
3.8.8
Resuming an initial calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75
3.8.9
Resuming the initial 100% point . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 76
3.8.10
Entering or changing the ISI and/or the reference time . . . . . . . . . . . . . . . . 76
3.8.11
Deleting a calibration point . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 76
3.8.12
Deleting a calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77
3.8.13
Validating a calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77
3.8.14
Canceling a calibration in progress . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 78
3.8.15
Printing a calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 78
3.9
Archives . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 78
3.9.1
Deleting patient files - Archives Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79
3.9.2
Sorting patient files - Archives Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79
3
0931634-NT - October 2007
Content
REFERENCE MANUAL
3.10
Test setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79
3.10.1
Creating a test setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79
3.10.2
Copying a test setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 80
3.10.3
Creating a dependent test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 80
3.10.4
Creating a calculated test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81
3.10.5
Changing a test setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 82
3.10.6
Updating a test setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 82
3.10.7
Updating several test setups . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 83
3.10.8
Deleting a test setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 84
3.11
Shutting down STA-R Evolution . . . . . . . . . . . . . . . . . . . . . . . . . . . . 84
3.11.1
Routine shut down . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 84
3.11.2
Prolonged shut down . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 86
4
0931634-NT - October 2007
REFERENCE MANUAL
Routine use
3 Routine use
3.1 Meaning of icons and symbols
3.1.1 Meaning of symbols
Patient file
Rack
Product
Calibration
Quality
control
Useable
1st calibration
validated
Validated
Empty task list
2nd calibration
validated
At least one test
in progress
At least one
tube with tests
in progress
Product due to
expire (on
board volume
<20% and/or
close to the
end of stability
time / length of
use)
1st calibration
in progress
In progress
2nd calibration
in progress
At least one test
to be validated
1st calibration
to be validated
To be
validated
2nd calibration
to be validated
At least one test
in error
Unuseable
1st calibration
not performed
or erroneous
Not
performed or
erroneous
2nd calibration
erroneous
Validated
3-1
0931634-NT - October 2007
REFERENCE MANUAL
Routine use
Patient file
Rack
Product
Calibration
Quality
control
Download
request carried
out for this file
Patient file
transmitted
Patient file
identified
manually or reidentified
Patient file
printed
Stat
Sample loaded
into a pediatric
microcontainer or
tube
Stat with
sample tube
loaded into a
pediatric microcontainer or
tube
Corresponds to
a calibrator
Corresponds to
a quality control
One or more
alarms are
associated with
the result
Patient file
printed (or to
be printed)
3-2
0931634-NT - October 2007
REFERENCE MANUAL
Routine use
3.1.2 Meaning of the icons
Function panel
Display the screen for right-handed
or left-handed users
Display the Patient menu
Display the Products menu
Display the Calibration menu
Display the Quality Control menu
Display the Setup menu
Display the contextual help
Display the Stat menu
Display the Maintenance menu
Control panel
Display the Archives menu
Display the Search menu
Suspend sampling
Resume sampling
Suspend transmission
Resume transmission
Load in normal mode
Automatically unload the unread

tubes
Load in manual mode
Load a rack
Load all racks
Tag files or Untag files
System panel
When flashing, a calibration is to be
validated or is erroneous

3-3
0931634-NT - October 2007
Routine use
REFERENCE MANUAL
When flashing, a test is blocked due

to lack of product (reagent, control
or calibrator)
When flashing, the samples are

blocked (insufficient Desorb,
manual blocking of samples etc.)

blocked because of lack of
calibration
When flashing, the photometric

tests are blocked because of an
error detected in the photometry
circuit
Restart the analyzer
Emergency shutdown
Exit system
Run printing
Display the analyzer control

screen
Status of the tests
Test waiting to be processed
Distribution of the sample in the

cuvette
Distribution of the intermediate

reagent(s)
Distribution of the releasing

reagent
Cuvette undergoing incubation
Chronometric measurement in
progress
Colorimetric measurement in
progress (405 nm)
Immunological measurement in
progress (540 nm)
Test blocked because of lack of

product
Test blocked by the operator
Test requested for a patient file with

sample tube waiting to be loaded
(not on board)
Test blocked by lack of calibration
Patient file
Set the patient file in normal mode
Set the file in stat mode
Transmitting a patient file
Validating the file
Display detailed description of the

alarm(s) associated with the results
Display the result main board
3-4
0931634-NT - October 2007
REFERENCE MANUAL
Routine use
Products
Load a cuvette roll
Load an STA-Cleaner Solution

bottle
Product requiring stirring by the

magnetic stirring device
Product contained in a microcup
Test rerun, for example after a

technical error (missing ball etc.) or
because of detection of a time
period less than the min. time
(<Vmin) or greater than the max.
time (>Vmax)
Test started again because of a

problem in detection of level
Results
V>
Vmax
For the chronometric tests: raw

measurement greater than the
max. time defined in the test setup,
or if the linear extrapolation is
desactivated: raw measurement
greater than the max. time in the
calibration.
For the colorimetric tests: the raw
result of the test is out of the
measurement range supported by
the calibration test
V<
Vmin

measurement less than the min.
time defined in the test setup, or if
the linear extrapolation is
less than the min. time in the
calibration.
Error
Technical error
Lin.
Insufficient linearity for the

colorimetric or immunological tests
QNS
Quantity of plasma not sufficient
File completion
Modify a file
Add a file
Creation of a test profile
Quality control
Run a quality control manually
Change the result acceptance range
Delete a quality control result
Validate a quality control result
Delete all quality control results for

the level selected
Display the last quality control

result
3-5
0931634-NT - October 2007
Routine use
REFERENCE MANUAL
Transmit a control point
Display the days quality controls
Control missing for product drawer
Display the comments associated

with a quality control
Calibration
Display the 1st calibration
Display the 2nd calibration
Calibrator missing for product

drawer
Status of the racks
Rack present inside the analyzer
Rack unloading in progress
Rack that has been unloaded and

that is inside the tray
File present but tube is not loaded
Unloading / Reloading
Unload the tagged racks
Reload the racks located on the tray
Release the tray
3.2 Analyzer preparation

3.2.1 Turning the analyzer on
The STA-R Evolution is designed to operate 24 Hours by following the maintenance procedure
described in chapter 4 of this manual.
" Ensure that all the covers, doors and the product drawer of the STA-R Evolution are shut/closed
properly.
" Turn the printer power switch on.
" Turn the power switch of the STA-R Evolution to the On (I) position.
This switch is located on the bottom right side of the STA-R Evolution.
" Turn the monitor power switch on.
" Double click the icon
3-6
0931634-NT - October 2007
REFERENCE MANUAL
Routine use
The STA-R Evolution proceeds with the checks and corrects the problems that it detects in real
time (the check is displayed on the screen)
The software initialization window is displayed:
" Click the icon
to initialize the main software application faster.
The following message may be displayed:

"Rack Conveyor Initialization
Do you want to initialize the rack conveyor?": click
and tubes on the conveyor to be re-identified, or
if you want all the racks

to avoid the conveyor being initialized.
The following message is displayed:

"If you are sure that no sample was moved
press Yes to cancel the Init.", click
Note: If one or more products are missing, the
to confirm or if not, click
icon flashes for 15 seconds. An alarm will
sound at the same time. The list of missing products will be displayed when you click the
icon.
The STA-R Evolution is ready to be used.

Note: If an error message about temperature is displayed, wait 5 minutes for the temperature to
stabilize then close the message by clicking the
icon.
3-7
0931634-NT - October 2007
Routine use
REFERENCE MANUAL
3.3 Loading/unloading consumables

3.3.1 Change the cuvette roll using bar code identification
The reagent cuvettes are disposable consumables. Diagnostica Stago cannot be liable for any
damages whatever, direct, indirect, material or immaterial if washed and/or reused cuvettes and/or
cuvettes other than those manufactured and distributed by Diagnostica Stago or distributed by its
official distributors are used.
Keep the plastic bag which contains the new cuvette roll to use it as a new disposal bag for the
cuvette bin.
Keep the cut off part of the plastic bag (see instruction on the bag) to use it as a link to close the
disposal bag (see procedure in chapter 3.3.2 of this manual).
Note: The bar code tracking option is now active for the cuvette rolls.
When the quantity of cuvettes has depleted, the following window appears:
" Click
The following window appears:
3-8
0931634-NT - October 2007
REFERENCE MANUAL
Routine use
" Open the upper right door.

" Lift the cuvette take up reel maintenance handle.
" Remove the cuvette take up reel by sliding it off the axle shaft.
" Open the door/flap to the cuvette loader.
The motor that powers the cuvette take up reel may turn.
" Lift the maintenance handle for the cuvette roll.

" Remove the cuvette roll by sliding off the axle shaft.
" Dispose of the cuvette roll and its cuvette take up reel.
Note: The new cuvette rolls are all supplied with a new cuvette take up reel.
" Take the new cuvette roll and cut along the dotted line. Keep both the plastic bag and the upper
part of the bag that has just been cut off. The former will be used as a new disposal bag for the
cuvettes bin, whereas the latter will be used as a link to tie up the used disposal bag (see
instructions on the plastic bag).
" When reading the cuvette roll bar code data, hold the bar code of the new cuvette roll in front
of the product drawer bar code reader. If these 2 bar code labels are not detected by the reader,
the information from both bar code labels can be typed manually.
" Click
showing the number of cuvettes and the code/batch of the roll that has just been loaded.
" Hold the new cuvette roll with the roll in your left hand and the cuvette take up reel in your right
hand.
3-9
0931634-NT - October 2007
Routine use
REFERENCE MANUAL
" Slide the new cuvette roll onto the axle shaft and lower the rolls maintenance handle.
" Slide the cuvette take up reel onto the axle shaft and lower the cuvette take up reels maintenance
handle.
" Put the film into the cuvette loader so that it is parallel to the loading rails, then close the cuvette
loader door/flap.
- Do not twist the film.

- Do not turn the cuvette take up reel by hand. Use the feed button (2) to move the take up reel
and advance the cuvette film..
" Press the feed button (2) to start feeding the cuvettes.
Cuvette take up reel
Cuvette feed button
Cuvette loader door/flap
" Ensure that the cuvettes enter the cuvette loader without twisting sideways. Keep pressing the
feed button until the cuvettes have been completely inserted into the loader.
" Close the upper right side door.
" Click
3-10
0931634-NT - October 2007
REFERENCE MANUAL
Routine use
" Proceed with changing the cuvette disposal bag (see procedure in chapter 3.3.2 of this manual).
Note: The software will allow you to load a new cuvette roll before the current cuvette roll is
completely empty:
" Directly access the changing cuvette rolls menu by clicking the
icon from the Products
screen. Follow the same procedure described in this chapter.
The previous cuvette rolls information will be saved (i.e.: quantity of cuvettes remaining at the
time of roll removal). This information will be restored when the cuvette roll is reloaded.
3.3.2 Change the cuvette disposal bag
The disposal bag contains biohazardous material. Handle the disposal bag and its content in
accordance with the local regulations: Wear disposable gloves.
" Open the front door.

" Remove the cuvette disposal bin (the furthest unit on the right).
" Unfold the plastic disposal bag and lift it out of the metal bin.
" Take the cut off part of the plastic bag containing the cuvette roll that has been previously loaded
(see chapter 3.3.1 of this manual) and use it as a link to tie up the disposal bag.
" Dispose of the plastic bag by following the regulations in force locally.
The disposal bag contains biohazardous material and should therefore be disposed of in accordance
with the regulations in force locally.
" Take the plastic bag containing the cuvette roll that has been previously loaded (see chapter 3.3.1
of this manual) and use it as a disposal bag for the cuvette bin.
" Open the plastic bag and put it in the metal disposal bin.
" Make sure the bag goes all the way down to the bottom of the bin.
" Fold the bag down over the sides of the bin.
3-11
0931634-NT - October 2007
Routine use
REFERENCE MANUAL
" Put the metal cuvette disposal bin back into the STA-R Evolution; this bin should be pushed to
the back of its casing until you hear the bin detection switch turn off.
Do not defeat the operation of the switch that detects the presence of the metal cuvette disposal
bin.
" Close the front door.
3.3.3 Loading the cleaner solution
The 2.5 liter container of waste solution contains biohazardous material and should therefore be
handled in accordance with the regulations in force locally: wear disposable gloves, mask and safety
goggles.
" Click the
icon and then press the
button.
The window below appears displaying
the message "Remove and
dispose of the Waste bottle. CAUTION: BIOHAZARD.".

disposed of in accordance with the regulations in force locally:
" Gently remove the 2.5 liter container of waste solution represented on the screen in blue (the
middle 2.5 liter container shown in the photograph above).
" Remove the cap from this 2.5 liter container as soon as possible.
Note: The symbol on the cap and the tubing leading to this cap is red to indicate that the contents
of the 2.5 liter container is biohazardous.
" Completely remove the 2.5 liter container of waste solution,
3-12
0931634-NT - October 2007
REFERENCE MANUAL
Routine use
The window below appears, displaying

move the Cleaner Solution Bottle.".
the message "Empty then
" Put the original screw on cap back onto the waste container and dispose of it in accordance with
the regulations in force locally.
Using permanent ink pen, mark the container of used solution "WASTE"; never use it as a new
vial of STA-Cleaner Solution; this can lead to incorrect results.
Note: The empty 2.5 liter container of STA-Cleaner Solution will be used as the new 2.5 liter
container for waste solution.
" Gently pull the empty 2.5 liter container of STA-Cleaner Solution (left-most 2.5 liter container).
" Remove the cap from this 2.5 liter container as soon as possible. Let the pipe hang outside the
analyzer so as to avoid any possible contamination.
" If necessary, empty the 2.5 liter container of STA-Cleaner Solution.
" Set the empty 2.5 liter container in front of the middle position so that you can put the cap and
the red tubing on to the empty container. Using permanent marking pen cross out the words
"STA-Cleaner Solution" found on the label. Mark the word "WASTE" on this container.
" Push the empty 2.5 liter container to the rear of its casing.
You should hear the switch that detects the presence of the 2.5 liter container closing. The
following window will then appear
displaying the message "Install a new Cleaner Solution.".
Do not defeat the operation of the switch that detects the presence of the 2.5 liter container of
waste solution.
3-13
0931634-NT - October 2007
Routine use
REFERENCE MANUAL
" Take a new 2.5 liter container of STA-Cleaner Solution.
The new STA-Cleaner Solution bottle must be at ambient temperature.
Do not swallow the STA-Cleaner Solution (in vitro use).

Do not modify its composition, it could lead to wrong results.
" Remove its cap.

" Put the 2.5 liter container of STA-Cleaner Solution in front of the left-most free area so that you
can put the pipe and the cap on it.
" Push the full 2.5 liter container to the rear of its casing.
following window will then appear:
15
displaying the message "Indicate the volume.".

" Confirm the volume indicated (2500ml) by clicking
enter the remaining volume and then confirm by clicking
if a new vial is used. If not,

.
3-14
0931634-NT - October 2007
REFERENCE MANUAL
Routine use
3.4 Loading/unloading the products

3.4.1 Warnings related to loading products
For all loading and unloading operations, the safety measures concerning handling of biohazardous
products must be taken in accordance with the regulations in force locally: in particular, wearing
disposable gloves, goggles and/or masks.
For all loading operations, do not defeat the various motions of the analyzer and to avoid confusion,
only handle one tube or vial at a time.
For all products (reagents, controls, calibrators, dilution buffer and decontaminating solutions),
please read carefully the notes that accompany each product and follow the procedures described.
Manual identification of product can lead to typing errors. It is used under complete responsability of
the user.
It is recommended not to turn off the STA-R Evolution. That allows the storage of the products on
board and their stability management.
Note: The LEDs next to the vial flash for products that are no longer valid in terms of volume and/
or stability and/or expiry date.
The expiry date and the lot number of the following products are not controlled by the analyzer:
STA-OWREN KOLLER buffer (TOK), STA-Desorb U solution, STA-CaCl2 reagent.
The operator must therefore check the expiry date of these products before loading them in the
analyzer.
Only the stability and volume of these products are controlled by the analyzer.
The stability of reagents which have been loaded and then reloaded are not controlled by the
analyzer and remains on the entire responsability of the user.
3.4.2 Open the Products drawer
You must use the software to open the Products drawer; do not attempt to open it manually.
3-15
0931634-NT - October 2007
Routine use
" Click the
REFERENCE MANUAL
icon,
" Click the Open tab,

If the STA-R Evolution is pipetting products from the drawer or needs the drawer to finish the
analyses in progress, a flashing window appears at the bottom of the screen and displays the
message "Open Drawer - Estimated Time x min. x s" and the estimated lapse of time before
opening.
" Click Cancel to cancel the request to open,
If not, the message "Drawer is about to open" is displayed.
Do not block the automatic opening of the Products drawer.
When the STA-R Evolution is ready to open the products drawer, the message disappears and
the tab heading Opening changes to Open Drawer. The drawer opens, the product bar code
reader lights and a beep sound is produced. Once the drawer is open, the tab heading changes
to Close Drawer.
If the drawer opens immediately, no message is displayed; and the events proceed as described
above.
Note: While the products drawer is open, sampling is stopped and no function other than contextual
help is accessible.
When the drawer is open, do not put your hand or any object inside the STA-R Evolution.
3.4.3 Loading a product with bar code identification

" Open the Products drawer,
" Place the vials bar code label in front of the products bar code reader. If the bar code reader does
not work properly, you need to identify the products manually (see procedure in chapter 3.4.4
of this manual).
" If the contents of the vial have been decanted to a STA<-microcup, check the empty box beside
, by pressing the F8 button or by clicking the empty area of the
button to display the
symbol,
3-16
0931634-NT - October 2007
REFERENCE MANUAL
Routine use
" Change the volume if necessary and then use the
key to confirm,
Volume is to be entered in ml, according to the following data entry template:

" Put the vial in a position that corresponds to its diameter, observing the loading areas and the
magnetic stirrer positions. If automatic recognition of position fails to work properly, you need to
load the products without positive identification (see procedure in chapter 3.4.5 of this manual).
" For calibrators and controls, if the batch is already known, vial loading is stopped.
For reagents, if the batch is already known and if at least one calibration has already been started
or validated, vial loading is stopped.
" If a new lot number is detected, the following question is displayed "Do you wish to read the
calibration parameters using the barcodes?". To proceed immediately with the bar code
reading, click
; put the sheet in front of the bar code reader and then click
.
If the bar code reader fails to work properly, you need to enter the bar code information manually
(see procedure in chapter 3.4.4 of this manual).
" If there is at least one methodology that can be calibrated with this new batch, a window listing
all the methodologies that use this product is displayed. You can then click
to start calibration.
The calibration will be carried out for Stago methodologies precalibrated or in raw mode or ratio
mode for which a calibration should be carried out.
For some methodologies, entering parameters such as the "reference time" or the ISI is
requested; the following window is then superimposed on the display:
3-17
0931634-NT - October 2007
Routine use
REFERENCE MANUAL
For Diagnostica Stago calibrators and controls, the values are correctly assigned in the appropriate
test if the primary unit selected for them is the same as the one defined in the barcode sheet in each
box of controls (except for Fibrinogen where for the primary unit in g/l, the values will be correctly
assigned even if they are given in mg/dl on the sticker).
The value of the ISI for Prothrombin should be the one indicated in the product note. Any change
in batch, any software update as for any intervention - should give rise to checking the ISI value.
3.4.4 Loading a product using manual identification

" Type the product identification as it is defined in the Test setup menu, then confirm by clicking
,
" If the contents of the vial have been decanted to an STA<-microcups, check the empty box beside
, by pressing F8 or by clicking the empty area of the
display the
button to
symbol,
" Type the batch number; then confirm by clicking

key to confirm,
3-18
0931634-NT - October 2007
REFERENCE MANUAL
Routine use
If a new lot number is detected, the following question is displayed "Do you wish to read the
reading, click
.
For some methodologies, the entering of parameters such as the "reference time" or ISI is
requested.
Note: For products that are not part of the STA< line, the threshold values must be entered for
controls, as well as the concentration values of the calibrators.
3.4.5 Loading a product without positive identification of the positions

If positive identification is no longer in operation for the product drawer (completely or partially), the
position of the vials can be entered manually.
This procedure requires extra attention from the operator, who must ensure that the positions
indicated in fact correspond to the positionings that have been carried out.
For all the tubes or vials that are loaded using this procedure (non-operational positive
identification), it is absolutely necessary to observe the unloading procedure without positive
identification.
If after loading the vial, the position is not displayed.

" Open the drop-down list of the
positions by clicking the
arrow,
" Click the position that corresponds to that of the vial. In the Products drawer, this position is
shown on the right side of the vial.
" Click
3-19
0931634-NT - October 2007
Routine use
REFERENCE MANUAL
3.4.6 Unloading the products using positive identification

This procedure is only possible if positive identification is operational: that is, automatic recognition
of the loading position in the drawer by the STA-R Evolution.
" Remove the vials one by one.
3.4.7 Unloading the products without positive identification

This procedure is absolutely necessary for products loaded when positive identification no longer
works.
" Look for the product to be unloaded (sort the products if necessary and use the vertical scroll
bar),
Reminder: The
letter symbol is displayed for the products that have been loaded without
positive identification.
" Click the product line,
" Simultaneously press the CTRL and DEL keys: the following question is displayed:
"Remove Product?
Identity - Product name
pos.: Product position"
" Remove the vial from the Products drawer; then click
to confirm.
3.4.8 Close the Products drawer
You must use the software to close the Products drawer; do not attempt to close it manually.
" Click the Close drawer tab,

" The drawer closes.
Do not block the automatic closing of the Products drawer.
3-20
0931634-NT - October 2007
REFERENCE MANUAL
Routine use
The heading of the Close drawer tab changes to Open drawer.

The software automatically displays the List of products screen.
Note: If one or more products is missing, the Missing Products window appears for 15 seconds
and an alarm rings at the same time.
You can:
-
run sampling,
open the drawer to load the missing products (the list of missing products is displayed when we
click the icon
),
block sampling.
3.4.9 Enter the bar code information manually

This procedure is to be followed if the bar code reader does not operate normally (reader problem
or bar code printing problem).
After the question "Do you wish to read the calibration parameters using the barcodes?" to
accept click
, Reading the Bar Code Stickers window now appears.
" Double click "Please pass the label in front of the barcode reader",
" Enter the information provided below the bar code and use the
of each line.
" When you have entered all the lines, click
" Click
key to validate it at the end
3.4.10 Sorting products - Product list screen

The products may be sorted by a criterion to be selected from among 8 possibilities. These
correspond to the 8 columns in the List of Products, screen, that is: ID, Product Name, Type,
Pos., Lot, Shel-life, Expiry date, Volume on board.
This procedure can be implemented whether the drawer is open or closed.
3-21
0931634-NT - October 2007
Routine use
" Click the
REFERENCE MANUAL
icon,
" Click the List of Products tab (to perform the sort with the drawer closed) or click the Open
tab (to perform the sort with the drawer open),
" Click the column heading that matches the criterion that the sort is to be performed on.
When you click ID, you sort the products by increasing identification.
When you click Product Name, you sort the products alphabetically.
When you click Type, you find the controls at the top of the list, followed by the diluents, the
calibrators, the cleaning solutions and finally the reagents.
When you click Pos, the products are sorted by their location in the drawer (R0, R1 and last,
R2). Inside each zone, they are sorted by increasing position.
When you click Lot, the products are sorted by ascending batch number.
When you click Stab., the products are sorted by increasing stability.
When you click Date-Hour, End of use, you find the products whose expiry date and time are
the closest at the top of the list.
When you click On board, the products are sorted by ascending on board volume.
3.4.11 Sorting products Forcecast Screen

This screen allows you to visualize quickly the missing volumes of products required to carry out the
work load.
correspond to the 4 columns in the Forecast screen, that is: R., ID, Product name and Margin.
" Click the
icon,
" Click the Forecast tab,

" Click the column heading that matches the criterion that the sort is to be performed on (R., ID,
Product name or Margin).
When you click R, the products are sorted by location int the drawer (R0, R1 and last, R2).
When you click ID, the products are sorted by ascending ID.
When you click Product name, you find the products whose names begin with a, then b and
so on at the top of the list.
When you click Margin, the products are sorted incrementally by volume: the missing products
are at the top of the list.
3.5 Quality control

If the result of a quality control does not meet the norms, all the results since the last correct quality
control with a validated status should be called into question.
Security levels (passwords) may be defined for some functionalities related to quality controls (see
procedure in chapter 5.14 of this manual).
3-22
0931634-NT - October 2007
REFERENCE MANUAL
Routine use
3.5.1 Running a quality control manually

You run a quality control from the quality control menu.
" Click the
icon,
" Look for the test for which a control is to be run,

" Click the abbreviation for the test,
" Click the Control level # tab (# corresponds to the level number you are looking for),
" Click the
button,

"Test: Abbreviation of the selected test Level: Selected level
Run the control?"
" Click
to confirm.
Note: The
icon in the system panel flashes if a quality control is to be validated or is
erroneous. This icon may be accompanied by a ringing alarm if this option has been selected in the
Global Options screen, Miscellaneous section (see procedure in chapter 5.11.5 of this manual).
If the
icon flashes in the system panel:
" Double click the flashing
icon,
The Daily Controls screen appears with the cursor on the last quality control result ("To be
validated" or "Erroneous").
" Place the cursor on the quality control that is to be run,
" Click the
button,

Run the control?"
" Click
to confirm.
3.5.2 Validating a quality control result
If the results of the quality controls do not meet the norms, all results since the last good quality
control should be put into question.
3-23
0931634-NT - October 2007
REFERENCE MANUAL
Routine use
A quality control can be validated either by using the flashing

be going to the quality control menu.
icon in the System panel, or
Note: the flashing

icon displayed in the system panel indicates if a quality control result needs
to be validated or is erroneous. This icon may be accompanied by a ringing alarm if this option has
been selected in the Global Options screen, (Miscellaneous section).
Using the flashing icon
icon,
The Daily Controls screen appears with the cursor on the last quality control result.
" Place the cursor on the quality control that is to be validated,
" Click the
button,

"Test: Abbreviation of the selected test Date: Date when the control was performed Time:
Time when the control was performed Result: Result of the selected control)
Level x
Do you really want to validate this point?"
" Click
to confirm,
The Validation comment screen is displayed.

" Type the comment and click
From the quality control menu:

" Click the
icon,
" Look for the test for which a control is to be validated,

" Click the
button,

Level x
" Click
to confirm.

3-24
0931427D - October 2007
REFERENCE MANUAL
Routine use
3.5.3 Deleting a quality control result

A quality control can be deleted either by using the flashing
going to the quality control menu.
icon in the System panel, or be
Note: the flashing

icon in the system panel is displayed if a quality control is to be validated
or is erroneous. This icon may be accompanied by a ringing alarm if this option has been selected in
the Global Options screen, (Miscellaneous section).
icon,
" Place the cursor on the quality control that is to be deleted,
" Click the
button,

Level x
Attention!!! Do you really want to delete this QC point?"
" Click
to confirm.
The Deletion comment screen is displayed.


" Click the
icon,
" Look for the test which a control is to be deleted for,

" Click the
button,

Level x
Click
to confirm.
3-25
0931634-NT - October 2007
REFERENCE MANUAL
Routine use
3.5.4 Display the days controls

Purpose: Viewing all the days controls in chronological order.
" Click the
" Click the
icon,
icon,
The Daily controls screen appears:
For each quality control value, the following information is displayed:

-
ldentity,
the minimum and maximum acceptance thresholds,
the unit.
In the table, the following information is displayed:

-
the abbreviation for the test (identified by the Test column heading on the screen),
the level of the control (identified by the Level column heading on the screen),
the result (identified by the Result heading on the screen),
the time (identified by the Time heading on the screen),
the condition for running the control:
automatically run depending on time
3-26
0931634-NT - October 2007
REFERENCE MANUAL
Routine use
automatically run as a function of the number of tests

automatically run at each change of vial
run manually by the operator
the status.
You can sort the daily controls according to a type of information (test abbreviation, result, etc.) by
clicking the heading of the column you want to use.
You can sort in reverse order by clicking the heading twice.
The order of the sort is used when the document is printed.
Note: You can validate, delete or rerun a control by double-clicking or right-clicking the control.
3.5.5 Displaying the last quality control result

Purpose: To return to the last quality control performed when you moved to the various graphical
areas on the Quality control screen.
" Click the

button: the data related to the last control carried out is displayed in the various
areas of the Quality control screen.
Another procedure may be used to display the last control carried out:
" Click the abbreviation for another test,
" Click the abbreviation for the test you want again.
3.5.6 Printing the days controls

" Click the
" Click the

" Click icon
printed.
icon,
icon,
to print the days controls; all information concerning the control will be
All the days controls are printed.

For each quality control value, the following information is printed:
-
the abbreviation for the test (identified as Test at the time the controls are printed),
the identity for the control (identified as Level when the control is printed),
3-27
0931634-NT - October 2007
Routine use
-
REFERENCE MANUAL
the batch number (identified as Lot when the control is printed),

the result (identified as Result when the control is printed),
the minimum and maximum acceptance thresholds, (identified as Min and Max when the control
is printed),
the time and date (identified as Date at the time the controls are printed),
the status (identified as Status at the time the controls are printed),
The information entered in the Global Options menu (Title 1 and Title 2) are printed on every page
at the bottom left of each page.
The pages are identified by their page number / total number of pages.
3.5.7 Displaying and printing the quality controls for a given period
" Click the
" Click the
icon,
icon,
The daily controls window appears.
" Click the
icon,
3-28
0931634-NT - October 2007
REFERENCE MANUAL
Routine use
" Use the arrows to select the range you want and then by click
period.
to confirm the
The daily controls for the requested period are displayed:
" Click icon
to print.
Note: The commands Validate, Rerun or Delete are only activated for the daily controls (selection
of the control on the days date + right click).
3.5.8 Printing a quality control in graphical mode

" Click the
icon,
" Look for the test for which the quality controls are to be printed,
" Select a point on the graphic (see procedure in chapter 5.9.8.1 of this manual),
" Click the
icon to print.
3-29
0931634-NT - October 2007
Routine use
REFERENCE MANUAL
" Select Current level: 1. or All Levels. to print only the current level or all quality control levels.
All information related to the point selected will be printed.
On each page (table pages and graphics pages):
-
the abbreviation for the complete test name (identified as Methodology when the control is
printed),
is printed),
the time and date of the result as well as the value of the point selected,
On the tables page:

-
Table for the selected day

- the time (identified as Time when the control is printed),
- the result (identified as Result when the control is printed),
- the type of operation (identified as Running when the control is printed),
- the batch,
- the minimum value (Min) and maximum value (Max),
- the mean, the sigma and the CV
Table of daily totals

- day of the month (identified as Date when the table is printed),
- mean of the quality controls every day of the month (identified as Mean when the table is
printed)
- standard deviation of the quality controls every day of the month (identified as Sigma when the
table is printed)
Table of monthly totals

- number of the month (identified as Date when the table is printed),
- mean of the quality controls for every month (identified as Mean when the table is printed)
- standard deviation of the quality controls for every month (identified as Sigma when the table
is printed)
On the graphics page:

-
graph of daily controls

graph of daily totals
graph of monthly totals
3-30
0931634-NT - October 2007
REFERENCE MANUAL
Routine use
3.5.9 Changing the values of the thresholds for a quality control

" Click the
icon,
" Look for the test whose control threshold values are to be changed,
" Click the
button,
The Change thresholds window appears with the new values to be entered as well as the
original values.
" Enter the new thresholds,
" Click
to confirm.
3.5.10 Transmitting a control result

" Click the
icon,
" Look for the test whose control is to be transmitted,

" Click the
button,

Level x
Do you want to upload this point?"
" Click
to confirm.
3.5.11 Deleting all quality control results for a level

" Click the
icon,
" Look for the test for which all quality control results are to be deleted,
3-31
0931634-NT - October 2007
REFERENCE MANUAL
Routine use
" Click the
button,

"Test: Abbreviation of the selected test
Level: Selected level
ATTENTION!!! Do you want to delete all the QC points?"
" Click
to confirm: all quality control results for the displayed level are deleted.

The typed comment is associated to every deleted point.
3.6 Loading/unloading the samples
For all loading operations, do not block the various motions of the analyzer and to avoid confusion,
Manual identification can lead to typing errors. It is used under complete responsability of the user.
3.6.1 Loading a Patient tube
Only use centrifuged tubes for the samples; check that there is enough plasma, that there is no foam
and that no clot or micro-clot might interfere with the results.
Use the green pediatric rack for the loading of pediatric sample tubes and the blue rack intended
for microcontainers for the loading of microcontainer sample tubes.
When a microcontainer rack is loaded, make sure that the number of the rack is displayed in blue
in the test panel and that the microcontainer status is given to the patient in the Patient Acquisition
screen.
3-32
0931634-NT - October 2007
REFERENCE MANUAL
Routine use
It is recommended to use a bar code label to identify the sample tubes. This can be printed by the
STA-R Evolution, see procedure in chapter 4.10.1 of this manual. You can also load tubes without
labels.
Please choose the case that corresponds to your situation:
Loading tubes with automatic identification by the bar code reader:
3-33
0931634-NT - October 2007
REFERENCE MANUAL
Routine use
Standard loading
Emergency (STAT)
loading
Test selection
Procedure
Chapter
Downloading
Case n1
3.6.2
Automatic profile
Case n2
3.6.3
Automatic identification
Case n3
3.6.4
Manual identification
Case n4
3.6.5
and automatic
incrementation
Case n5
3.6.6
Case n6
3.6.7
Case n7
3.6.8
NOTES:
When loading tubes, if the list of tests is downloaded, the operator should check coherence between
patient identity and the list of tests for this patient.
Manual entry of information is the operators responsibility.
The operator should use 2 bar code types at most to:
-
optimize bar code reading speed for the aforementioned bar codes,
limit the risk of bar code reading error related to the number of bar code types to be recognized.
A rack should never be loaded without the tray except when emergency loading is taking place.
When emergency loading is taking place, you must nonetheless wait until the analyzer invites you to
load the rack before introducing it into the analyzer.
If a rack has come out of the rack anti-fall device unexpectedly, the user should remove this rack
with care, stop the analyzer using the
button and then restart the software for the analyzer.
3.6.2 Loading a rack of tubes / automatic identification mode Case n1

-
Bar code labels provided by the laboratory
Selecting tests for downloading
" Click the
icon,
3-34
0931634-NT - October 2007
REFERENCE MANUAL
Routine use
" In the Control Panel tab, check either the
icon to automatically read and load the tubes,
or the
icon if you want the unread tubes to be automatically unloaded for identification
(this option is selected through the screen Global Options, see chapter 5.12 of this manual,
section Miscellaneous, see chapter 5.12.5 of this manual),
" Click the (Un)Loading tab,
" Check the Downloading checkbox to display the
symbol.
" Put the previously centrifuged tubes into the racks,

" Put the racks into the rack tray,
" Put the rack tray into the analyzer: The tubes are automatically loaded, their bar codes are read
and for each tube, the request for the work list is made to the central server. The analyzer
automatically performs the analyses.
Note: In automatic unloading of unread tubes

, when a tube is not read at loading time, it is
automatically taken to the stat loading position and the Manual Input of patient IDs window
appears for re-identification.

-
Selection of tests by automatic profile
" Click the
icon,

icon is displayed, or the
icon if you want
the unread tubes to be automatically unloaded for re-identification (this option is selected
through the Global Options screen, see chapter 5.12 of this manual, section Miscellaneous, see
chapter 5.12.5 of this manual),
" If necessary, define the automatic profile (see procedure in chapter 3.7.2.1 of this manual),
" Check the Add Automatic Profile checkbox to display the
symbol.

" Put the rack tray on the analyzer: The tubes are automatically loaded, their bar code labels are
scanned and the test profile is added to each patient identification. The analyzer automatically
performs the analyses.
3-35
0931634-NT - October 2007
REFERENCE MANUAL
Routine use


-
Manual test selection
" Click the
icon,

icon if you want
" Put the rack tray into the analyzer:
The tubes are automatically loaded and their bar code labels are read,
" Add the tests: either through the Test panel or through the Patient Acquisition screen; see
procedure in chapter 3.7.2 of this manual.
, when a tube is not read at loading time, it
is automatically taken to the stat loading position and the Manual Input of patient IDs window

" Click the
icon,
" In the Control Panel tab, check that the

screen, then click the
icon or the
icon is displayed (if it does not appear on the
icon),

" Put the rack tray into the analyzer: The tubes are loaded automatically and the Manual Input of
patient IDs screen appears:
3-36
0931634-NT - October 2007
REFERENCE MANUAL
Routine use
" Double click the
The icon will be barred (
icon if the rack position is empty;
).
" Locate the picture of the rack found at the bottom left of the Manual Input screen. Double click
on the position of the sample tube within this rack. Manually enter the patient identity and status.
" Choose the analyses to be carried out:
-
by selecting them manually from the list of tests,

by selecting the automatic profile or one of the six pre-defined profiles in the Manual Input of
patient IDs menu.
Note: the analyses to carry out can be defined in the (Un)Loading menu (Addition of automatic
profil or Downloading),
" Click
to confirm.
Note: When stat loading is requested in manual identification mode, the stat checkbox is checked
by default (this checkbox can be cleared when you load).
On loading, the bar code reader checks coherence between rack positions and the information that
has been entered. If there is a mismatch, the following message is displayed:
"There are IDs without a tube.
Please press UNLOAD to correct or IGNORE"
or
"There are tubes without a corresponding ID.
or
"There are tubes without an ID and IDs without a tube.
You can:
-
ignore this step; in this case, the analyzer only works with tubes that are actually physically
present,
3-37
0931634-NT - October 2007
REFERENCE MANUAL
Routine use
-
re-display the Manual Input of patients IDs screen to correct the error by clicking
.
3.6.6 Loading a rack of tubes / manual identification mode Case n5

" Click the
icon,

icon or the

icon),

patients IDs screen appears:
" Double click the

" Click the
).
button,
The Incrementation options screen appears:
3-38
0931634-NT - October 2007
REFERENCE MANUAL
Routine use
" You can enter the following information:

-
the prefix,
the starting number,
the incremental value,
the status,
the type of profile.
" Click the
button,
The incrementation options are applied to all samples.

Note: All identities, statuses or tests can always be changed manually.
" Load the first rack by clicking

, or load all the racks by clicking
(in this case, the
incrementation options are applied to all samples but no change is possible).
Note: If all the racks must be loaded
, the following message appears:
"Do you want to load all the racks with an automatic ID incrementation?"
" Click OK to confirm
Note: When a stat loading is requested in the manual identification mode, the stat checkbox is
checked by default (this checkbox can be cleared during the loading).
During the loading process, the bar code reader checks the coherence between the rack positions
and the information that has been typed manually. If there is an incoherence, the following message
appears:
-
In case of individual rack loading
"There are IDs without a tube

" Click Unload.
The rack is taken out and the Manual Input of patient IDs window appears.
" Click Ignore.
The rack is loaded and only the identities detected by the bar code reader appear in the test
panel.
3-39
0931634-NT - October 2007
REFERENCE MANUAL
Routine use
In case all the racks should be loaded
"Warning
There are IDs without a tube
Rack/Position: xxxxxx/x"
" Click OK to confirm.
This message is displayed as information; the analyzer only works with the tubes that are
physically present.
3.6.7 Urgent (STAT) loading of a rack of tubes / manual identification mode Case
n6
" In the Test Panel tab, check that the

then click the
icon or the
icon is displayed (if it does not appear on the screen,
icon),
" Put the previously centrifuged tubes onto the rack,

" Click the
icon,

"Please make sure there is no rack in loading position before the end of Initialisation.
Press OK to Continue.".
" Click
to confirm,
The Manual Input of patient IDs screen appears:
Note: When entering information, do not use the following characters:

&, , ", (, -, , _, , , ), =
" Click the position of the rack in the drawing,
" Enter identity and status
3-40
0931634-NT - October 2007
REFERENCE MANUAL
Routine use

patient IDs menu.
" Click
to confirm the information entered
" Wait for the following screen to appear:
" Load the rack into the STAT position

Transferring the rack to the analyzer.
3.6.8 Urgent (STAT) loading of a rack of tubes / automatic identification mode

Case n7
Manual selection of tests by downloading or by automatic profile
" In the Test panel tab, check either the
icon to automatically read and load the tubes, or
the
icon if you want the unread tubes to be automatically unloaded for re-identification
(this option is selected through the Global Options screen, see chapter 5.12 of this manual,
" Click the
icon,

"Please make sure there is no rack in loading position before the end of the
initialisation.
Press OK to continue.".
3-41
0931634-NT - October 2007
Routine use
" Click
REFERENCE MANUAL
to confirm,
" Load the rack into the STAT position: the rack is automatically loaded; its bar code labels are
read and for each tube, the request in the work list that was made to the server or the automatic
profile is applied if one of these options has been selected.
The analyzer automatically performs the analyses.
Note: If the Downloading option or the Automatic profile option has not been selected,
enter the analyses to be carried out:
- From the Manual Input of patient IDs menu: by selecting one of the six pre-defined profiles
- From the Test panel: by double clicking the test abbreviation
3.6.9 Tagging racks

Selects racks in order to unload them or to associate an action with them (Print/Download).
" Click the
icon,

" Move the cursor to the rack that you want to tag (vertical scroll bar),
" Click
column,
to tag the rack (or click directly inside the T column): the
sign appears in the T
" Proceed in the same way with the next racks.
3.6.10 Tagging all racks

" Click the
icon,
3-42
0931634-NT - October 2007
REFERENCE MANUAL
Routine use
" Click the T column heading,

" Click Tag All,
For all the racks, the
sign appears in the T column (rack tagged).
3.6.11 Removing the tag from all the racks

" Click the
icon,

" Click Untag All,
sign disappears from the T column.
3.6.12 Removing the tag from some racks

" Click the
icon,

" Move the cursor to the rack whose tag is to be removed (vertical scroll bar),
" Click
to remove the tag from the rack (or click directly inside the T column): the
disappears from the T column,
sign
3.6.13 Sorting the racks

The racks may be sorted by one of 2 criteria. This criteria is the Rack and Status columns.
" Click the
icon,

" Click the heading of the column that matches the criterion which the sort is to be done on (Rack
or Status).
For example, by clicking Rack, you find the racks with numbers beginning with 0 at the top of the
list, then with 1 and so on until you reach the rack number beginning with 9.
When you click Status, the racks inside the analyzer show up at the top of the list in loading order;
then you have the racks that were unloaded and that are in the tray.
3-43
0931634-NT - October 2007
Routine use
REFERENCE MANUAL
3.6.14 Printing the list of racks

" Click the
icon,
" The list of racks is printed:
3.6.15 Unloading a rack

" Click the
icon,

" Double click the rack to be unloaded,
"Unload a rack?
Rack: xxx?".
" Click
to confirm,
3-44
0931634-NT - October 2007
REFERENCE MANUAL
Routine use
When transferring the rack to the tray, the icon representing the rack becomes
Make sure that you position the rack correctly in the tray before unlocking the tray and removing it
from the analyzer.
" Click the
icon to release the tray,
" Remove the tray (see procedure in chapter 3.6.19 of this manual)
3.6.16 Unloading several racks

" Click the
icon,

" Tag the racks to be unloaded; see procedure in chapter 3.6.9 of this manual,
" Click

"Unload the tagged racks?".
" Click
to confirm,
When transferring the racks to the tray, the icon representing the rack becomes
You must then release the tray before you can remove it from the analyzer.
" Click the
3.6.17 Unloading all the racks

" Click the
icon,
3-45
0931634-NT - October 2007
REFERENCE MANUAL
Routine use
" Tag all the racks; see procedure in chapter 3.6.10 of this manual,
" Click

Click
to confirm,
When transferring the racks to the tray, the icon representing the racks becomes
The tray is automatically released.
3.6.18 Reloading a rack after the unloading of a tube

After unloading one or several racks to take one or several tubes out, the rack(s) located on the tray
can be reloaded with the
rack(s).
button. It allows the resuming of tests for the other tubes of the
" From the (Un)loading tab, unload the rack(s) containing the tube(s) that must be unloaded (see
chapters 3.6.15 and 3.6.16 for the unloading of racks).
The rack is transferred to the tray and the reloading button appears on the right of the button for
the unloading of tagged identities.
The reloading button appears if:

- the Automatic Unloading mode is not activated
- a tube identity can be reloaded
A tube identity can be reloaded if:
- at the first loading, the identity (bar code) of the tube is correctly read (the tube is not identified
as a unread tube)
- at the first loading, this identity has not been modified using manual identification or automatic
identification
If an identity cannot be reloaded, it is archived when the reloading of the tray is complete.
" Remove the requested tube(s).

" Click
to reload the rack(s) on the tray.

Do you want to reload the racks being on the tray?
Click
to confirm.
The operation is automatically canceled if, after 10 seconds, the reloading of the racks is not
confirmed.
3-46
0931634-NT - October 2007
REFERENCE MANUAL
Routine use
The rack is reloaded in the analyzer and the analyses are resumed.
Identification of reloaded tubes

- Reloading a rack in automatic identification mode:
When racks are reloaded, tubes barcodes are reread one after the other.
Missing tubes are automatically archived.
Present tubes are replaced on the test panel and their workload is resumed.
- Reloading a rack in manual identification mode:
If the rack had been loaded in manual identification or autoincrementation mode, the manual
identification of the same identities is allowed.
If the rack had been loaded in automatic mode, manual identification or autoincrementation
determination of a barcoded identity which is likely to be reloaded is forbidden (a message appears
for 10 seconds).
The previous results are then archived and restored in the test panel.
Any rerun on a given result will overwrite it.
Beside, all the tubes in the rack identified as unread tubes and are automatically archived with the
status "in progress". These tubes cannot be restored in the test panel.
Unloading a tube requiring an automatic rerun (with or without redilution)
-
If a test must be rerun and the relevant tube is on the tray when the result of the measurement
implying the rerun is given, the test takes an "Error" status in the test panel.
If the patient files are archived (for example if the tray has been removed), they will not be rerun
if they are resumed. However, if the tube has been reloaded before the measurement result is
given, then it will be rerun (see chapter 5.4.7 of this manual).
3.6.19 Release the tray

" Click
The tray is released; the area around the tray changes from red to green indicating that the tray
can be removed.
3-47
0931634-NT - October 2007
Routine use
REFERENCE MANUAL
3.7 Processing patient files

3.7.1 Tagging patient files
3.7.1.1 Tagging patient files Control panel

" Click the
icon,
" Click the Test panel tab,

" Move the cursor to the file that you want to tag (vertical scroll bar),
" Click
to tag the file or click on the file to be tagged in the T column: the
in the T column,
sign appears
" Proceed in the same way with the next files.
3.7.1.2 Tagging all the patient files

" Click the
icon,

" Click Tag all
The following message is briefly displayed:
"Modification in progress..."
for all the files, the
sign appears in the T column.
3.7.1.3 Tagging patient files - Archives Menu

" Click the
" Click the
icon,
button to look for an archived patient file.
" Click Search By.

" Choose the search key by clicking Identity, Name, First Name (these three keys correspond
to the first complementary information), or click Date.
3-48
0931634-NT - October 2007
REFERENCE MANUAL
Routine use
" Click Search.

" If Identity, Name or First Name have been selected as the search key, enter the full or partial
identification of the patient.
" Or change the date selection window.
" Click
to confirm.
The list of files that match the selection is displayed.

" Then, click Tag all,
" or move the cursor to the file that you want to tag (vertical scroll bar),
to tag the file or click on the files that you want to tag in the T column,
" Click
sign appears in the T column for all tagged files,
The

" Click the
icon to return to the control panel.
Note: in order to search a patients file loaded in the past according to his/her identity, start the
research by date and then by identity.
3.7.1.4 Removing the tags from all the patient files

" Click the
icon,

" Click Untag all,
sign disappears in the T column.
3.7.1.5 Removing the tag from a patient file

" Click the
icon,

" Move the cursor to the file whose tag is to be removed (vertical scroll bar),
" Click
to remove the tag from the file or click on the file in question in the T column: the
sign disappears from the T column,
3-49
0931634-NT - October 2007
Routine use
REFERENCE MANUAL
3.7.2 Adding a test
3.7.2.1 Defining or changing a test profile

" Click the
icon,
" Click the Patient Acquisition tab,

" Click the
button,
" Click Automatic (profile for loading racks) or Profile nx (x = number of the profile to be
defined or changed): the tests included in the profile are identified by a green triangle
" Click the
button.
" Select the tests you want by clicking the abbreviation of the displayed tests (use the scroll bar to
look for each test's abbreviation): a green triangle
appears. To remove a test that has already
been selected, click it again; the green triangle will disappear.
" If the samples are stat, choose Yes in the STAT File area,
" In the Sample Type area, choose the type of sample tubes: Standard for 5 ml tubes, Tainer
for plasmas transferred in micro-containers or Pediatric for 3ml tubes;
" Click the
button,
The list of tests associated with the profile is displayed
3-50
0931634-NT - October 2007
REFERENCE MANUAL
Routine use
3.7.2.2 Adding a test to a patient file in the test panel

" Click the
icon,
" Use the
icon or the vertical scroll bar to look for the patient file,
" Look for the test that you want to add to the patient file using the horizontal scroll bar (bottom),
" Double click the test checkbox,
"Add a test?
Test: Abbreviation of the selected test ID: Identity of the selected patient"
" Click the
button to confirm,
The selected test is added.
3.7.2.3 Adding one or more tests to a patient file Patient Acquisition screen
" Click the
icon,

" Click the patient file for which the tests are to be added,
" Click the
icon,
" Click the abbreviation of the test to be associated (use the scroll bar if the abbreviation for the
test does not appear in the list),: a green triangle
tests.
" Click the
appears. Repeat this procedure to add other
button.
3.7.2.4 Adding a test to several patient files

" Click the
icon,
" Use the
3-51
0931634-NT - October 2007
Routine use
REFERENCE MANUAL
" Tag the files for which the test is to be added,

The
sign appears in the T column for the tagged files,
" Use the horizontal scroll bar to look for the test,
" Click the abbreviation of the test (at the top of the column),
" Click Add,
"Add Test for all Tagged Identities?
Test: Abbreviation of the selected test"
" Click the
button to confirm: for all the tagged files; the selected test will be added.
3.7.2.5 Adding a test profile to a patient file

" Click the
icon,

" Click the
icon,
" Click the profile to be applied (to view the tests for the profile, click
" To delete the tests applied to the patient file, click the
" Click the
),
button,
button.
3.7.2.6 Adding a test profile to several patient files

Note: You can edit 6 different profiles using 10 tests at the most for each profile.
" Click the
icon,

" Tag the files for which the profile is to be applied by clicking the files to be tagged in the T column,
The
sign appears in the T column for all the tagged files,

" Click Apply Profile to Tagged Identities,
"Apply Profile for All Tagged Identities?
Profile No. x (x= number of the profile that you want to add)"
3-52
0931634-NT - October 2007
REFERENCE MANUAL
Routine use
" Click the
button to confirm.
The profile is applied to all the files selected.
3.7.2.7 Downloading the work list

" Click the
icon,
" Use the
" Tagging the file to be downloaded,

The
sign appears in the T column for the tagged file,

" Click Download Tagged Identities,
"Download All Tagged Identities?".
For all tagged files, the request for the work list is made to the server. The analyzer automatically
3.7.3 Blocking/unblocking tests
3.7.3.1 Blocking sampling

" Click the
icon,
" Click the
button
All sampling is blocked. The

panel.
button is displayed and the
icon flashes in the control
3.7.3.2 Blocking a test for all the patient files

" Click the
icon,
3-53
0931634-NT - October 2007
Routine use
REFERENCE MANUAL

" Click Block,
"Block all tests for this methodology?
Abbreviation of the selected test"
" Click the
button to confirm
All the tests on the waiting list are blocked and the test abbreviation and the unit (column heading)
turn brown.
Note: The
this manual).
icon is displayed when the blocked test is run (see procedure in chapter 3.7.2.4 of
3.7.3.3 Blocking a test for a selection of patient files

Note: It is possible to block a test for a selection of patient files only if the test has been run and is
waiting to be processed (
icon). Moreover, the first sampling can be run for the first patient file
displayed on the test panel, even if it has been blocked.

" Click the
icon,

" Tag the patient identities to block (see procedure in chapter 3.7.1 of this manual),
" Click Block Tagged Identities,
"Block Test for all Tagged Identities?
" Click the
button to confirm
The test is blocked for all the selected patient files. The
icon is displayed in the column
corresponding to the blocked test.
3.7.3.4 Unblocking sampling

" Click the
icon,
3-54
0931634-NT - October 2007
REFERENCE MANUAL
" Click the
Routine use
button
All sampling is unblocked and the
button is displayed.
3.7.3.5 Unblocking a test for all the patient files
" Click the
icon,

" Click Unblock,
"Unblock all tests for this methodology?
" Click the
button to confirm
All the tests are unblocked and the test abbreviation and the unit (column heading) turn black.
3.7.3.6 Unblocking a test for a selection of patient files
" Click the
icon,

" Click Unblock Tagged Identities,
"Unblock Test for all Tagged Identities?
" Click the
button to confirm
The test is unblocked for all the selected patient files.
3-55
0931634-NT - October 2007
Routine use
REFERENCE MANUAL
3.7.4 Rerunning a test
3.7.4.1 Rerunning a test for a patient file in the test panel
" Click the
icon,
" Use the
" Double click the test checkbox (result displayed),
" Click Rerun (single assay = rerunning the measurement once; duplicate assay = rerunning 2
measurements),
"Rerun a test?
" Or for assays in duplicate, double click Rerun Measurement No. 1 (only reruns the first
measurement) or Rerun Measurement No. 2 (only reruns the second measurement),
"Rerun a test? (Measurement No. 1) or (Measurement No. 2)
Click the
button to confirm.
3.7.4.2 Rerunning a test from the Patient File screen

" Click the
icon,
" Use the
" Double click the file identification: The Patient File screen appears,
" Double click the test,
measurements),
"Rerun a test?
3-56
0931634-NT - October 2007
REFERENCE MANUAL
Routine use
" Or for assays in duplicate, click Rerun Measurement No. 1 (only reruns the first measurement)
or Rerun Measurement No. 2 (only reruns the second measurement),
" Click the
button to confirm.
3.7.4.3 Rerunning a test for several patient files
" Click the
icon,
" Use the
" Tag the files for which the test is to be rerun,

The
measurements),
"Rerun Test for all Tagged Identities?
" Or for assays in duplicate, double click Rerun measurement No. 1 (only reruns the first
measurements) or Rerun measurement No. 2 (only reruns the second measurements),
(Measurement No. 1) or (Measurement No. 2)
" Click the
button to confirm.
3.7.5 Deleting a test
3.7.5.1 Deleting a test for a patient file in the Control panel

" Click the
icon,
3-57
0931634-NT - October 2007
Routine use
" Use the
REFERENCE MANUAL
" Double click the test checkbox that has the result displayed or shows an icon:
(tube missing)
calibration),
(product missing)
(test blocked)
(test blocked because of lack of
" Click Delete,

"Delete a Test?
" Click the
button to confirm.
3.7.5.2 Deleting a test for several patient files

" Click the
icon,
" Use the
" Tag the files for which the test is to be deleted,

The
" Click Delete,
"Delete Test for all Tagged Identities?
Test: Abbreviation of the selected test
" Click the
button to confirm.
3.7.5.3 Deleting a test from the Patient File screen

" Click the
icon,
" Use the
3-58
0931634-NT - October 2007
REFERENCE MANUAL
Routine use
" Double click the test that has the result displayed or shows an icon:
(tube missing)
(test blocked)
(test blocked because of lack of calibration),
" Click Delete,

"Delete a Test?
" Click the
button to confirm.
3.7.6 Validating the results
3.7.6.1 Alarms associated with the results

Patient File Screen -
Button
quality control that is substandard or has not been performed
substandard quality control validated by the operator
detection of un-administered level for arm n3 (R2 area reagents)
detection of un-administered level for arm n1 (R0 area samples and products)
result in main unit is limited to the default values
result obtained after re-dilution
result rerun
reagent drawer temperature out of bounds
maintenance overdue for syringe in arm 3
incorrect duplicate tolerance
The alarms associated with a result are classified by level of seriousness (from more serious to less
serious).
3-59
0931634-NT - October 2007
Routine use
REFERENCE MANUAL
3.7.6.2 Validating results Archives menu

" Click the
icon,
" Click the

" Click the
icon,
" Click Search By.

" Choose the search key by clicking Identity, Name, First Name, (these three keys correspond
" Click Search.
" Click
to confirm.

" Click the file to be tagged in the T column to tag the files to be validated (identified by the
triangle)
The

" Then click Validate Tagged Identities,
"Validate all Tagged Identities?"
" Click
to confirm.
" Click the
3.7.6.3 Validating results in the Control panel

" Click the
icon,
triangle)
The

3-60
0931634-NT - October 2007
REFERENCE MANUAL
Routine use

" Click
to confirm.
" Click the
3.7.7 Viewing a result
3.7.7.1 Viewing the results

" Click the
icon,
" Click the Test panel tab, ten patient files are displayed.
" Use the vertical scroll bar to view the other files,
" Use the horizontal scroll bar to view the other tests,
" OR look for the file and then double click it to consult the full file.
3.7.7.2 Viewing a result (photometry) as a graph

" Click the
icon,
" Use the
" Double click the test check box displaying the measurement in progress icon (
or with a result displayed,
or
" Click Graphics (single assay),

" Or for the assays in duplicate, click Graphics No. 1 (viewing the graph for the first dosage) or
Graphics No. 2 (viewing the graph for the second dosage). The Graphics screen appears.
" Click the
Note: Viewing results of photometric measurement as a graph is only available for samples (this
functionality does not exist for calibrators or for controls).
Note: You cannot print photometric graphs.
3-61
0931634-NT - October 2007
Routine use
REFERENCE MANUAL
3.7.8 Transmitting results
3.7.8.1 Transmitting a patient file

" Click the
icon,
" Use the
" Double click the file identification: the Patient File screen appears,
" Click the
icon,

"Upload an identity?
ID: Identity of the selected patient"
" Click the
button to confirm,
If the on line transmission is active, the test results are transmitted to the server depending on
the option selected in the On line transmission part (this option is selected in the screen Global
Options, see chapter 5.12 of this manual, Miscellaneous section, see chapter 5.12.5 of this
manual): All Results or Only Validated Results.
3.7.8.2 Transmitting several patient files

" Click the
icon,
" Use the
" Tag the files to be transmitted,

The

" Click Upload Tagged Identities,
"Upload All Tagged Identities?"
" Click the
button to confirm,
3-62
0931634-NT - October 2007
REFERENCE MANUAL
Routine use
Options, see chapter 5.12 of this manual, section Miscellaneous, see chapter 5.12.5 of this
3.7.8.3 Transmitting a test for a patient file in the Test panel

" Click the
icon,
" Use the
" Double click the test checkbox (result(s) displayed),
" Click Upload,
"Upload a Result?
" Click the
button to confirm,
3.7.8.4 Transmitting a test for a patient file Patient File screen

" Click the
icon,
" Use the
" Double click the test (the result is displayed with Validated or To be validated status),
Click Upload,
"Upload a result?
ID: Identity of the selected patient".
" Click the
button to confirm.
3-63
0931634-NT - October 2007
Routine use
REFERENCE MANUAL
3.7.8.5 Transmitting a test for several patient files

" Click the
icon,
" Use the
" Tag the files for which the test is to be transmitted,

The
" Click Upload,
"Upload Test for all Tagged Identities?
" Click the
button to confirm,
3.7.8.6 Transmitting results Archives menu

" Click the
icon,
" Click the
icon,
" Click the files to be tagged in the T column to tag the files to be transmitted,
The

" Then click Upload Tagged Identites,
"Upload all Tagged Identities?"
" Click the
button to confirm
3-64
0931634-NT - October 2007
REFERENCE MANUAL
Routine use
" Click the
3.7.9 Moving a sample that has already been loaded to STAT sample
3.7.9.1 Moving a sample that has already been loaded to STAT sample - Test panel
" Click the
icon,
" Use the
" Double click the file identification,

" Click the
icon,
3.7.9.2 Moving a sample that has already been loaded to stat - Patient Acquisition screen
" Click the
icon,

" Click the patient file that is to be moved to stat,
" Click the
icon,
" Select Yes in the STAT File area,

" Click the
button.
3.7.10 Looking for a patient file

" Click the
icon,
3-65
0931634-NT - October 2007
Routine use
" Click the
REFERENCE MANUAL
icon,
" Click Search By,

" Choose the search key by clicking Identity (or Name or First Name that correspond to the
primary complementary information),
" Click Search,
" appearEnter the identification you are looking for (or some of the complementary information:
name or first name) and either click the
button or press the
key to confirm. The
cursor moves to the file that you want, or a Key not found... message is displayed.
3.7.11 Printing patient files

Printing patient files can be done from the control panel, the Archives menu or the User Menu
menu.
-
From the Test Panel: to print the validated files that have not yet been archived (all or only some
of them). The files are printed on one page (see procedure in chapter 3.7.11.1 of this manual).
In the Archives menu: to print validated and archived files (all or only some of them). The files
are printed on one page (see procedure in chapter 3.7.11.2 of this manual).
In the User Menu menu (located in the Maintenance

menu): to print any validated file
(regardless of wether the file is archived or not). The files are printed page by page. You can
customize printing of the files in this menu (see procedure in chapter 3.7.11.3 of this manual).
3.7.11.1 Printing a non-archived file from the control panel

" From the control panel, tag the patient files to be printed (see procedure in chapter 3.7.1 of this
manual),
" Click the
icon to print the tagged files.

"Print All Tagged Files?"
" Click
to confirm.
The files are printed on one page.
3-66
0931634-NT - October 2007
REFERENCE MANUAL
Routine use
3.7.11.2 Printing an archived file
" From the control panel, click the
icon to access the archives.
" Tag the patient files to be printed (see procedure in chapter 3.7.1 of this manual),
" Click on the
icon or
" Click the T column heading then click Print All Tagged Files,
" Click
to confirm.
3.7.11.3 Customizing printing of an archived or an un-archived file

This function allows you to customize printing of patient files according to the specific needs of each
laboratory.
This function is available for validated patient files (files that are to be validated, are erroneous, in
progress or empty can not be printed).
Customizing printing is done in the User Menu tab,
To access this tab, no measurement may be in progress; the open and archived files are blocked.
Choose the files to be printed:
" Click the
icon to access the Maintenance menu,
" Click the User Menu tab,

" Click the
button,
The screen for selecting files to print appears.

" In the first drop down list, choose the type of file to display (open or archived files),
The list of files is displayed at the top right of the screen.
" To obtain information on a patient file, click it,
The information is displayed in a pop up window called "Information on the patient file" table
at the bottom of the screen.
" Double click the name of the file in the list of files to tag the files to be printed in duplicate.
The # sign appears to the left of the selected file.
" In the second drop down list, select the files to print:
-
Current file: The file selected from the list

Marked # not printed: the files tagged with the # sign in the list of files and that have never
been printed
Marked #: all the files tagged with the # sign in the list of files
3-67
0931634-NT - October 2007
REFERENCE MANUAL
Routine use
" Click the
icon to print the selected files.
The * sign appears to the right of the printed files.

Customize the titles:
The location and the type of information related to the files (patient identification, test names,
results) are unchangeable; only the titles of the headings or the extra remarks are defined by each
laboratory.
A single file per page is printed.
" Click the

" Click the
" Click the
button,
button,
The customization screen appears.

" Change the titles on the basis of the laboratory.
" Click the
icon,
The previous screen (for selecting files) appears. It is changed on the basis of the selected
parameters.
3.7.12 Changing the display of the test panel
3.7.12.1 Choose displaying the single/duplicate results in the test panel

This option is only available for the tests that have been carried out in duplicate and if the unit chosen
for display is the primary unit or the raw unit.
Note: a D for the tests in duplicate is displayed beside the unit.
" Click the
icon,

" Click Display Measurement,
" Click Measurements 1 and 2: display of both results in the main unit (or raw),
" Or click Mean: display of the mean in the primary (or the raw) unit.
3-68
0931634-NT - October 2007
REFERENCE MANUAL
Routine use
3.7.12.2 Choose the unit in which to display the results in the Control panel
For each test, you can choose the unit for control panel display.
" Click the
icon,

" Click Units: the units available for this test are displayed,
" Click the unit you want.
3.7.12.3 Sorting the patient files

File sorting criteria has 6 possibilities to choose from. These criteria match the 6 columns that have
information corresponding to the patient files. For example: T (tagging files), Identity,
(checkbox color), Rack, Po (Position in the rack), Sts (file specifics).
" Click the
icon,

" Click the heading of the column that matches the criterion which the sort should be done on
(Identity,
, Rack, Po or Sts).
For example, by clicking the Identity column, the results are sorted numerically and then
alphabetically.
When you click
, the patient files are classified in the following order: blue (file to be validated),
white (validated file), yellow (file in progress); red (erroneous file) and grey (empty file).
When you click Rack, you find the files for which the tubes have not been loaded at the top of the
list, then the files whose rack number begins with 0, then with 1 and so on until the rack numbers
beginning with 9. At the end of the list, you have the calibrators and the controls when these are
being processed.
When you click Po, you find the files for which the tubes have not been loaded at the top of the list,
then the files whose tubes have been loaded into position 1 in the racks, then those that have been
loaded into position 2 and so on. For a given category (for example, tubes loaded into position 1),
the files are listed in the order that the tubes were loaded.
When you click Sts, the stat files are at the top of the list in the order that the tubes were loaded;
then you have the non-stat files also listed in the order that the tubes were loaded.
" Or click the T column heading,
3-69
0931634-NT - October 2007
Routine use
REFERENCE MANUAL
" Then click Sort by Tag: all the tagged files are at the top of the list.
3.7.13 Adding a note to a patient file

To add an additional note to a patient identification, see chapter 5.10.2 of this manual.
3.8 Calibration
Security levels (passwords) can be applied to some functionalities associated to calibrations (see
chapter 5.14 of this manual).
3.8.1 Running a calibration Calibration screen

The procedure to run calibration can only be used when a new batch is loaded for a reagent or when
no calibration has been run for the batch.
Note: The products have already been loaded.
" Click the
icon,
" Double click the test that is to be calibrated,

Note: If there is already a validated calibration with another batch number, you must click
before continuing with the procedure.
If two calibrations already exist for a test and a new batch is to be calibrated, you need to delete one
of the two existing calibrations.
" Click Calibrate...,
" Click
to confirm.
The Lot selection window appears:

" Double click the reagent(s) to be able to select the batch to calibrate,
3-70
0931634-NT - October 2007
REFERENCE MANUAL
Routine use
Batch number is displayed in green; the vial is present and is may be

used.
Batch number in red; the vial is present but cannot be used (insufficient
volume and/or stability overdue).
Batch number in gray; the vial is not present.
Unknown batch
Displayed if the vial is not present or if it is present but has calibration

parameters that have not been read.
Already calibrated
Displayed if the selected batch has been calibrated in the other curve.
" Click the batch to calibrate,

" Click
to confirm.
3.8.2 Automatic calibration

If there are already two calibrations for a test and if a new batch is to be calibrated, you need to delete
one of the two calibrations (otherwise the former one will be automatically deleted).
From the List of products screen
" Open the products drawer
" Follow the procedure for loading products as outlined in chapters 3.4.3 or 3.4.4
" When a new batch is detected, the following question is displayed : "Do you wish to read the
calibration parameters using the barcodes?", click
The Barcode reading of sheet screen appears.
" Hold the bar code label included in the kit in front of the bar code reader
3-71
0931634-NT - October 2007
REFERENCE MANUAL
Routine use
The product parameters are displayed in the window.
" Click
" If there is at least a methodology to calibrate, the following window appears:
" To run calibration of methodologies that can be run, click
" If you need to provide some parameters such as reference time and ISI, a text entry window
appears for each methodology that requires this specification:
" Enter the parameter(s), then click

" Double click the product for which you want to run a calibration; the following window appears:
3-72
0931634-NT - October 2007
REFERENCE MANUAL
Routine use
3.8.3 Changing a calibration point

" Click the
icon,
" Click the test for which a calibration point is to be changed,

" To choose the calibration, click
or
" Click the Calibration Pts. tab,

" Double click the line that matches the point to be changed,
" Click Modify Point,
" Enter the new value for the calibration point in the Current value line;
" Click
to confirm
The letter M appears on the line.

3-73
0931634-NT - October 2007
REFERENCE MANUAL
Routine use
" Click
to confirm.
3.8.4 Changing the100% point

Note: This option is only offered if chronometric tests use % as the main unit and also have the linear
measurement scale and the inverse concentration scale. This allows the calibration curve to move
parallel to itself so as to move through the new point given in seconds that corresponds to 100%.
" Click the
icon,
" Click the test for which a 100% point is to be changed,

or
" Double click the abbreviation for the test,

" Click Edit 100% Pt,
" Enter the time in seconds that corresponds to the value of the laboratorys 100% point,
" Click
to confirm,

"Reference Time initialized"
" Click
to confirm.
3.8.5 Rerunning a calibration

Note: You cannot rerun a calibration if the test is pre-calibrated.
" Click the
icon,
" Click the test for which the calibration is to be rerun,

or

" Click Rerun this calibration,
"Methodology test abbreviation
Do you really want to rerun this calibration N#selected calibration ?"
" Click
to confirm.
3.8.6 Rerunning a calibration point

Note: You cannot rerun a calibration point if the test is pre-calibrated.
3-74
0931634-NT - October 2007
REFERENCE MANUAL
Routine use
" Click the
icon,
" Click the test for which a calibration point is to be rerun,

or
" Click the Calibration of points tab,

" Double click the line that corresponds to the point to be changed,
" Click Rerun Point,
"Do you want to rerun calibration point No. xx?"
" Click
to confirm. The calibration point is rerun once in the case of single determination
and twice in that of duplicate determination.
3.8.7 Resuming an initial calibration point

Purpose: Resuming a calibration point as set before the point was changed or deleted.
" Click the
icon,
" Click the test for which a calibration point is to be resumed,

or

" Double click the line that corresponds to the point to be resumed,
" Click Restore Init Point,
" Click
to confirm.
3.8.8 Resuming an initial calibration

Purpose: Resuming the calibration as set before it was changed.
" Look for the test which the calibration should be resumed,
or

" Click Retreive Initial Calibration?,
"Methodology abreviation of the test
Retreive Initial Calibration",
" Click
to confirm.
3-75
0931634-NT - October 2007
REFERENCE MANUAL
Routine use
3.8.9 Resuming the initial 100% point

Purpose: Resuming the 100% point as set before it was changed.
" Click the
icon,
" Click the test for which a 100% point is to be resumed,

or

" Click Modify Pt 100%,
" Enter the previous value of the 100% point for the laboratory in seconds (this corresponds to
Initial Value xx.x Sec),
" Click
to confirm,

" Click
to confirm.
3.8.10 Entering or changing the ISI and/or the reference time

" Click the
icon,
" Click the test for which the coefficient is to be changed,

or

" Click Edit Ref. Time and ISI,
" Click the ISI area; then enter the ISI coefficient value,
" And/or click the Reference Time area; then enter the laboratory reference time in seconds,
" Click
to confirm.
Note: If the reference time is modified, it is used as reference for the INR calculation.
3.8.11 Deleting a calibration point

" Click the
icon,
" Click the test for which a calibration point is to be deleted,
3-76
0931634-NT - October 2007
REFERENCE MANUAL
Routine use
or

" Double click the line that corresponds to the point to be deleted,
" Click Delete Point,
The letter D appears on the line.
" Click
to confirm.
3.8.12 Deleting a calibration

" Click the
icon,
" Click the test for which the calibration is to be deleted,

or

" Click Deleting this calibration...,
Do you really want to delete this calibration? #1"
" Click
to confirm.
3.8.13 Validating a calibration

A calibration can be validated either by using the
accessing the calibration menu.
icon flashing in the system panel, or by
Note: The
icon in the system panel flashes if a calibration is to be validated or is erroneous.
This icon may be accompanied by a ringing alarm if this option has been selected in the Global
Options screen, (Miscellaneous section).
" Click the
icon or double click the
icon flashing in the system panel,
" Look for the test for which the calibration is to be validated (identified with a
the text To be Confirmed is displayed beside the regression coefficient,
blue triangle):

" Click Validate the Regression Coefficient,
"The Regression Coefficient for this calibration
must be at least x.xxx
y-yyy"
3-77
0931634-NT - October 2007
Routine use
REFERENCE MANUAL
where:
-
x.xxx = value of the regression coefficient (this can be negative) entered in the Global Options
screen,
y.yyy = value of the regression coefficient for the calibration.
" Click
to confirm.
3.8.14 Canceling a calibration in progress

" Click the
icon,
" Look for the test for which the calibration in progress is to be deleted (identified with a
yellow triangle):
" Click Cancel the calibration in progress?,
"Methodology Test: xx
Do you really want to cancel this calibration?"
" Click
to confirm,
The previous calibration is automatically redisplayed.
3.8.15 Printing a calibration

" Click the
icon,
" Choose the test for which the calibration is to be printed,

Note: If there are several validated calibrations, click
calibration is to be printed.
" Click the
or
depending on which
icon,
3.9 Archives
From the Archives menu, you can also:
-
tag the patient files to be printed (see procedure in chapter 3.7.1.3 of this manual),
look for the patient files (see procedure in chapter 3.7.1.3 of this manual),
transmit the results (see procedure in chapter 3.7.8.6 of this manual),
validate the results (see procedure in chapter 3.7.6.2 of this manual),
print the results (see procedure in chapter 3.7.11.2 of this manual).
3-78
0931634-NT - October 2007
REFERENCE MANUAL
Routine use
3.9.1 Deleting patient files - Archives Menu

icon to access the Archives menu.

" Then click Delete Tagged Identities.
"Delete All Tagged Identities?"
" Click
to confirm.
3.9.2 Sorting patient files - Archives Menu


" Then click Sort By Tag: all the tagged files are at the top of the list.
3.10 Test setup
The laboratory has the responsibility for entering the bar codes correctly and for choosing the
appropriate test setup for a given test.
3.10.1 Creating a test setup

" Click the
icon,
" Click the Tests tab,

" Click the Methodology tab,
" Choose a main test from the list of tests,
3-79
0931634-NT - October 2007
REFERENCE MANUAL
Routine use
" Click the
button,
" Enter the abbreviation of the new test,

" Click
to confirm,
" If entering parameters is open, enter the information for each parameter,
" If entering parameters is multiple choice, use either:
-
the drop down list (accessible through the
the
the
button),
button,
button,
" Complete the 5 tabs for the test setup,

" Click
to confirm.
3.10.2 Copying a test setup

" Click the
icon,

" Choose the main test to be copied,
" Click the
button,
" Enter the abbreviation of the copied test,

" Click
to confirm,
" Changing the test setup,

" Click
to confirm.
3.10.3 Creating a dependent test

Note: Dependent tests are always displayed in italics.
" Click the
icon,

" Choose the main test from which the test is to be created,
" Click the
button,
3-80
0931634-NT - October 2007
REFERENCE MANUAL
Routine use
" Click Dependant,

" Changing the dependent test setup,
" Click
to confirm.
3.10.4 Creating a calculated test

Note: A calculated test is the result of a calculation using the result of two primary tests. They should
be based on the same measurement method type.
Calculated tests can not be blocked or rerun.
" Click the
icon,

" Choose the main test from which the calculated test is to be created,
" Click the
button,
The Test creation widow is displayed,

" Type the abbreviation of the copied test,
" Click Calculated,
" Click
to confirm,
" In the Setup tab, Identification part, type the abreviation and the name of the calculated test,
" In the Definition part, select the type of measurement methodology (chronometry, colorimetry
or immunology),
" In the M1 and M2 parts, select the primary tests 1 and 2 (only the tests compatible with the
defined method are displayed in the list),
" Select the calculation formula and choose the coefficient,
" In the Printout/Trans tab, Parameters part, select the transmission rank,
" In the Edition limits part, select the limits (Min. and Max.),
" Click Validate to confirm the addition of this test.
For more information about calculated tests, see chapter 5.11.2.1 of this manual.
3-81
0931634-NT - October 2007
Routine use
REFERENCE MANUAL
3.10.5 Changing a test setup

Note: You can only change a test setup if the test is not in progress (if it is contained in a patient file
whatever its status, calibration or QC in progress or waiting).
You can only change the method type of a primary test involved in a calculated test after you delete
the calculated test.
" Click the
icon,

" Choose the test to change,
" Click the
button,

" Click
to confirm.
3.10.6 Updating a test setup

Note: The analyzer should be idle; no result should be visible in the Test panel.
" Click the
icon,

" Click the
button,
In this way, you access the reference database.

Note: If the test is already present in the user database, it is displayed in blue. Otherwise, it is
displayed in grey.
" Click the
button to view the products used in a test setup; use the scroll bar to scroll
through all the products,
" Use the
button again to return to the list of tests in the reference database.
" Double click the test that is to be updated,

The abbreviation as well as the test name is displayed in white; the letter T appears in front of the
abbreviation of the test that is to be updated.
" Click the
icon,
3-82
0931634-NT - October 2007
REFERENCE MANUAL
Routine use
Note: If the test was already present in the user database, the following message is displayed:
"METHODOLOGY UPDATING
test abbreviation: Calibrations, QC and Dependent Tests will be deleted!!!"
" Click
to carry out the update.
The abbreviation as well as the test name is displayed in green, showing that the test has been
updated in the user database.
" Click the
button to return to the previous screen.
3.10.7 Updating several test setups

" Click the
icon,

" Click the
button,

" Click the
" Use the
" Double click the tests that are to be updated,

" Click the
icon,
The abbreviation as well as the test names is displayed in green, showing that the tests have been
Changes to the referenced products will be lost.
" Click
3-83
0931634-NT - October 2007
Routine use
" Click the
REFERENCE MANUAL
3.10.8 Deleting a test setup

Deleting a primary test brings about deletion of all dependent and calculated tests related to it.
" Click the
icon,

" Click the
button,
The message "Do you really want to delete xxx" is displayed,

" Click
to confirm.
3.11 Shutting down STA-R Evolution

3.11.1 Routine shut down
" Click the
icon,
The confirmation window is displayed:
" Click
" Wait until the software is shut down.

" Move the cursor to the bottom of the screen to display the taskbar.
" Click Start, then Turn Off Computer... or Shut Down according to the operating system
used.
The following window appears, depending on what operating system is used:
3-84
0931634-NT - October 2007
REFERENCE MANUAL
" Click
Routine use
or
" Wait for the message "It is now safe to turn off your computer" is displayed.
" Press the screens power supply switch.
" Turn the On/Off switch of the STA-R Evolution to the Off (O) position.
This switch is located on the right side of the STA-R Evolution.
" Press the printers power supply switch.
3-85
0931634-NT - October 2007
Routine use
REFERENCE MANUAL
3.11.2 Prolonged shut down
This procedure is to be followed if the analyzer is to be shut down for more than one week.
Follow the safety measures concerning handling products that are biohazardous according to the
regulations in force locally: wearing disposable gloves, a mask and protective goggles.
" Remove all the tubes and the products.

" Remove the bottles (dirty liquid and STA-Cleaner Solution).
" Dispose of the cuvette waste bin and the dirty liquid bottle according to the regulations in force
locally.
" Proceed with decontamination of the analyzer (see procedure in chapter 4.9 of this manual).
Before restarting the analyzer, follow the same decontamination procedure; then put the liquid and
cuvette waste bins back in place.
3-86
0931634-NT - October 2007
REFERENCE MANUAL
Content
Maintenance
4.1
Description of the maintenance utility . . . . . . . . . . . . . . . . . . . . . . . . . 1
4.2
Schedule of preventive maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . 2
4.2.1
Schedule of preventive maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
4.3
Daily preventive maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
4.3.1
Checking the condensation trap . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
4.3.2
Cleaning the touch screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
4.3.3
Specific maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
4.4
Weekly preventive maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
4.4.1
Cleaning the main air filter and the optic module case filter . . . . . . . . . . . . . 4
4.4.2
Cleaning the rinsing well and needles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
4.4.3
Cleaning rinsing well N3 and needle N3 with hydrochloric acid . . . . . . . . . 7
4.4.4
Purging the needles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
4.4.5
Purging needles using spray control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
4.4.6
Cleaning the product drawer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
4.4.7
Cleaning the measurement plate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
4.4.8
Cleaning the suction tip . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
4.4.9
Cleaning the conveyor belt (shuttle transporter) . . . . . . . . . . . . . . . . . . . . . 14
4.4.10
Cleaning the shuttles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
4.5
Monthly preventive maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
4.5.1
Changing Teflon tips of the syringes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
4.6
Quarterly preventive maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
4.6.1
Replacing air filters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
4.6.2
Replacing the bar code reader wheel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
.............................................. 1
1
0931634-NT - October 2007
Content
REFERENCE MANUAL
4.7
Curative maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
4.7.1
Cleaning the racks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
4.7.2
Cleaning the rack conveyor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
4.7.3
Cleaning the Cuvette loader . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
4.7.4
Cleaning the bar code reader wheel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
4.7.5
Cleaning the window of the samples and products bar code readers . . . . . 23
4.8
Replacing components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
4.8.1
Replacing a needle . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
4.8.2
Replacing the suction tip . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
4.8.3
Replacing the lamp . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
4.8.4
Replacing main fuses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
4.8.5
Replacing secondary fuses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
4.9
Decontamination . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
4.9.1
Decontamination procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
4.9.2
Preparation of the decontaminating solution . . . . . . . . . . . . . . . . . . . . . . . . 33
4.9.3
Decontaminating the mandrel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
4.10
Maintenance utilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
4.10.1
Printing the bar codes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
4.10.2
Backing up data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
4.10.3
Restoring of data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
4.10.4
Back-up of results (use of TDex) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
4.10.5
Remote link . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40
4.11
Description of the User Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45
4.11.1
Export CQ . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45
4.11.2
Printing the patient files . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48
4.11.3
Delete lot . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48
4.11.4
Archives Export . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50
4.11.5
Photo. graphics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51
2
0931634-NT - October 2007
REFERENCE MANUAL
4.11.6
Content
Tracking menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53
3
0931634-NT - October 2007
Content
REFERENCE MANUAL
4
0931634-NT - October 2007
REFERENCE MANUAL
Maintenance
4 Maintenance
4.1 Description of the maintenance utility
This maintenance utility allows the user to service the analyzer.

The end user maintenance utility is structured as follows:
4-1
0931634-NT - October 2007
Maintenance
REFERENCE MANUAL
4.2 Schedule of preventive maintenance

4.2.1 Schedule of preventive maintenance
This schedule is provided for a laboratory that performs approximately 500 tests per day. This
schedule is to be adapted according to the laboratorys test volume.
Frequency
Type of maintenance
Daily
Checking the condensation trap

Cleaning the touch screen
Weekly
Cleaning the main air filter and the optic module

Cleaning the rinsing well and needles
Purging the needles
Cleaning the product drawer
Cleaning the measurement plate
Cleaning the suction tip
Cleaning the conveyor belts
Cleaning the shuttles
Backing up data
Shutting down and restarting the analyzer following the usual
procedure.
Monthly
Replacing the Teflon tips and the O-rings
Quarterly
Replacing the air filters

Replacing the bar code reader wheel
4.3 Daily preventive maintenance

4.3.1 Checking the condensation trap
Daily preventive maintenance
Purpose: To avoid the presence of liquid in the vacuum pump.
" Click the
icon,
" Click the Maintenance button.
4-2
0931634-NT - October 2007
REFERENCE MANUAL
Maintenance
regulations in force locally: wearing disposable gloves, mask and safety goggles.
" Check the level of liquid in the condensation trap.

" If liquid is present, the condensation trap is to be drained.
" Unscrew the condensation trap reservoir in the reverse direction shown by the red arrow.
" Dispose of the contents according to the regulations in force locally.
" Put the reservoir back in place.
4.3.2 Cleaning the touch screen

Purpose: To avoid accumulation of dirt
" Click the
icon,

" Use a cloth that has been slightly moistened with ethanol (concentration between 20% and
40%).
" Put your hand on the top of the screen so as to be able to press areas of the screen (touch screen)
strongly using the thumb: this will block the cursor in this position.
" Meanwhile use the cloth to clean the other areas of the screen taking care to avoid streaking.
" Press another area with your thumb to finish cleaning.
4-3
0931634-NT - October 2007
Maintenance
REFERENCE MANUAL
4.3.3 Specific maintenance

The cap piercing needle requires daily maintenance. For servicing, refer to the procedure set out in
the Cap piercing option manual (ref. 0931239x).
4.4 Weekly preventive maintenance

Prerequisite: Make sure that the STA-Cleaner bottle contains at least 250 ml of STA-Cleaner.
4.4.1 Cleaning the main air filter and the optic module case filter
Weekly preventive maintenance
Purpose: To avoid internal overheating
" Click the
icon,

" Open the right hand front door.
" Remove the main air filter: this filter is located below the analyzer.
" Remove the coarse dirt particles from the filter.

" Rinse the main filter with water and then dry it.
" Put the air filter back in place paying attention to assembly orientation: the arrow must point to
the upper part of the analyzer.
" Remove the air filter from the optic module: open the lower right hand door and pull on the black
cover; vacuum out the dust and then replace the air filter.
The air filter for the optic module may not be washed; if it is damaged, replace it.
4-4
0931634-NT - October 2007
REFERENCE MANUAL
Maintenance
4.4.2 Cleaning the rinsing well and needles

Purpose: To clean the rinsing well and its tubing to ensure perfect suction and to avoid external
contamination of the needles.
To check the needles and if necessary, unblock them.
If the analyzer is equipped with a cap piercing needle, you need to carry out specific weekly
maintenance; refer to the procedure described in the "Cap piercing option" manual (ref 0931239x).
Note: If white colored deposits appear on the sides of needle N3, you should follow the procedure
in chapter 4.4.3 of this manual for Cleaning rinsing well N3 and needle N3 with hydrochloric acid.
" Click the
icon,

" Click the Rinse Well tab.
The Press the button for rinsing the wells... message is displayed.
" Click the

button,
The messages Home position in progress... and Arm is moving towards the front of the
STA-R are displayed for each arm.
" Click
to close these messages.
When arms 1, 2 and 3 are to the front, the message Drawer is going to open, please validate
is displayed.
regulations in force locally: wear disposable gloves.
" Click
,
The drawer opens and the message The drawer is opening, please wait... is displayed.
When it is open, the next message Press OK to continue is displayed.
" Click
,
The message Pour the decontamination solution into each well. When you have finished,
please validate appears.
" Lift the transparent cover.
" Fill each rinsing well to the level with the decontaminating solution (see preparation procedure
in chapter 4.9.2 of this manual).
" Wait 30 minutes during which you can clean the products drawer and the measurement plate.
4-5
0931634-NT - October 2007
Maintenance
REFERENCE MANUAL
" Meanwhile, put the appropriate mandrel (the metal rod delivered with each new needle) through
each needle.
" Click
,
The message "Drawer is going to close, please validate." is displayed.
" Click
,
The drawer closes and the message "Drawer is going to close, please wait..." is displayed.
When it has been closed, the next message "Press OK to continue." is displayed.
" Click
,
The message "To empty the wells, please validate." is displayed.
" Click
,
The rinsing wells are emptied and the messages "The wells are being emptied, please wait..."
and "Press OK to continue." are displayed.
" Click
,
The message "A circuit purge is going to be performed for each well, please validate." is
displayed.
" Click
,
Rinsing well n1 is purged and the messages "Please wait during the purge of the well 1." and
"Press OK to continue." are displayed.
" Click
,
" Click
,
" Click
,
A window displaying the message "The procedure was successful." appears.
" Click OK: go back to the beginning of the procedure.
4-6
0931634-NT - October 2007
REFERENCE MANUAL
Maintenance
" Click
" Click
" Proceed with decontamination of the mandrel:

-
put the mandrel into the decontaminating solution (see preparation procedure in chapter 4.9.2
of this manual),
for the solution to act, leave the mandrel in it for 30 minutes,
remove the mandrel; rinse it and then dry it.
" Run the quality controls for the routine tests.

" Compare the values obtained with the previous values. If the values of the quality controls are
coherent with the previous values, the STA-R Evolution may be used. If not, begin the
procedure again. If there are persistent problems, contact After-Sales Service.
4.4.3 Cleaning rinsing well N3 and needle N3 with hydrochloric acid

Purpose: To clean rinsing well N3 and its supply pipes to ensure perfect suction and to avoid
external contamination of needle N3 if white-colored deposits have appeared on the sides of the
needle.
To check the needle and if necessary, unplug it.
" Click the
icon,

" Click the Well Rin. tab.
The "Press the button for rinsing the wells..." message is displayed.
" Click the

button,
The messages "Home position in progress..." and "Arm is moving towards the front of the
STA-R" are displayed for each arm.
" Click
When arms 1, 2 and 3 are to the front, the message "The drawer is going to open, please
validate" is displayed.
" Click
,
The drawer opens and the message "The drawer is opening, please wait..." is displayed.
When it is open, the extra message "Press OK to continue." is displayed.
4-7
0931634-NT - October 2007
Maintenance
REFERENCE MANUAL
" Click
,
The message "Pour the decontamination solution into each well. When you have finished,
please validate." appears.
" Fill rinsing well N3 to the level with the 0.1N hydrochloric acid decontaminating solution.
0.1N hydrochloric acid can be produced in the following ways:
-
From 1N (1) hydrochloric acid by dilution to 1/10th, that is 5 ml of 1 N hydrochloric acid and 45
ml of distilled water.
From pure (2) hydrochloric acid said to be smoking - by dilution to 1/100th, that is 0.5 ml of
pure hydrochloric acid and 45 ml of distilled water.
(1)(2) these products are commonly found in laboratories.

" Put an empty STA Microcups with an adaptor in position R2-4.
" Close the transparent cover.
" Click
,
" Click
,
The drawer closes and the message "Drawer is closing, please wait..." is displayed.
When it is closed, the second message "Press OK to continue." is displayed.
" Open the upper left side door.
" Put needle N3 above the empty STA Microcups and then activate the plunger of the syringe
for needle N3 (point 3 in the figure below) in order to purge the tubes.
You must not remove the plunger from the syringe.
" Raise needle N 3 manually.

" Empty the STA Microcups according to the regulations in force locally.
" Fill an STA Microcups with the solution of 0.1N hydrochloric acid and put it into the adaptor
in position R2-4.
" Manually insert needle 3 into the 0.1N hydrochloric acid solution that is in the STA-Microcups.
" Draw the solution up into the needle and the connection piece by moving the plunger in the
syringe for needle 3 up and down (see figure below).
" Let it sit for 15 minutes and during this time, move the syringe plunger up and down several times.
4-8
0931634-NT - October 2007
REFERENCE MANUAL
Maintenance
" After 15 minutes, raise needle 3 manually and remove the 0.1N hydrochloric acid solution as well
as the adaptor.
" Click
,
" Click
,
The rinsing wells are emptied and the message "The wells are being emptied, please wait..."
is displayed.
When emptying has finished, the extra message "Press OK to continue." is displayed.
" Click
,
displayed.
" Click
,
Rinsing well n1 is purged and the message "Please wait during the purge of well 1" is
displayed.
When rinsing well n1 has been purged, the second message "Press OK to continue." is
displayed.
" Click
,
displayed.
displayed.
" Click
,
displayed.
When rinsing well n3 has been purged, the extra message "Press OK to continue." is displayed.
" Click
,
" Perform the well rinsing operation two more times without decontaminating solution (or purge
needle 3 twice).
" Click
to return to the Maintenance menu.

" Close the upper left side door and then put the tray back in place
" Click the
icon,
time (the check is displayed on the screen).
Note: Maintenance using the hydrochloric acid solution eliminates the need to use the maintenance
procedure with chlorine bleach that used to be carried out.
You should not plan on carrying out both types of rinsing: in other words, chlorine bleach and
hydrochloric acid, because contact between these two solutions may release gas.
4-9
0931634-NT - October 2007
Maintenance
REFERENCE MANUAL
Using 0.1 N hydrochloric acid in maintenance has no effect on later assays.
4.4.4 Purging the needles

Purpose: A purging procedure for needles in blind tests, for the needle purging procedure using
spray control, see procedure in chapter 4.4.5 of this manual.
" Click the
icon,

" Click the Ndle Purge tab.
The message "Choose a needle to purge..." is displayed.
" Click the

button, the
or the
button depending on which needle is to be purged.
The message:
"You have selected number x
Press OK to continue." is displayed.
x corresponds to the needle that is to be purged.
" Click
.
The message "Arm is moving towards washing wells and wells are emptied" is displayed,
the needle selected comes into position in the well, and then the extra message "Press OK to
continue." is displayed.
" Click
.
The messages "P-Axis being reset..." then "Press OK to continue." are displayed.
" Click
.
The messages "Reservoir filling in progress..." and then "Press OK to continue." are
displayed.
" Click
.
The message "Circuit purge in progress. Please wait..." is displayed. The circuit is purged and
then the second message "Press OK to continue." is displayed.
" Click
.
The messages "Home position in progress..." and then "Press OK to continue." are
displayed.
" Click
.
The message "The procedure was successful." is displayed.
" Click OK
Return to the choice of the needle.
" If necessary, proceed with purging other needles.
" Click
4-10
0931634-NT - October 2007
REFERENCE MANUAL
Maintenance
4.4.5 Purging needles using spray control

Purpose: To allow the user to check that the needle is not partially clogged and that the dispensed
volumes are correct.
A purging procedure for needles using spray control; for the blind spray needle purging procedure,
see procedure in chapter 4.4.4 of this manual.
" Click the
icon,

" Click the Ndle purge tab.
" Click Mode Test to display the
" Click the
button, the
symbol.
or the
The message
"You have selected number x. Press OK to continue." is displayed.
" Click
.
The message "Home position in progress...".
The arm moves to its home position; then the second message "Press OK to continue." is
displayed.
" Click
.
The message "Arm is moving..." is displayed; the arm moves towards the rinsing well. When the
arm is in position, the extra message "Press OK to continue." is displayed.
" Click
.
The message "You can move the Z-Axis manually" is displayed.
" Click
.
displayed.
" Adjust the height of the arm so that you can see the needle spray clearly; then click
The message "Circuit purge in progress. Please wait..." is displayed.
The circuit is purged; the spray is visible at the needle aperture.
" Check that the spray is straight:

-
that the needle is not clogged. If the spray is not straight, put the mandrel through the needle;
then carry out the test again
or put a graduated tube under the needle so as to check that the dispensed volume is correct;
this volume should be between 3 and 4 ml. If the dispensed. volume is wrong, put the mandrel
through the needle and then carry out a test again; if the problem persists, replace the needle.

A window displaying the message "Do you want more pulses?" appears.
4-11
0931634-NT - October 2007
Maintenance
REFERENCE MANUAL
" If necessary, click YES; if not, click NO.

If you have chosen NO: The message "Home position in progress..." is displayed.
displayed.
" Click
" Click OK
" Click
4.4.6 Cleaning the product drawer

Unload all the products from the analyzer before cleaning the product drawer (see procedure in
" Click the
icon,

" Check that no needle is left in the product drawer (in one of the positions or in one of the rinsing
wells). If there is a needle, raise it and push it to the back of the analyzer.
" Pull the products drawer open.
" Clean the top with a cloth or paper towel that is slightly moistened with hot water.
Wipe with a dry cloth.
" If a product vial (reagent, control, calibrator, diluent) has been broken, unscrew the captive
thumb screw under the drawer and then pull the card unit slowly upwards so that you can
disconnect the 2 cables. The earth cable (yellow and green) is disconnected by pulling it out; the
flat cable is disconnected by separating the 2 handles. Clean the 2 card unit with the
4-12
0931634-NT - October 2007
REFERENCE MANUAL
Maintenance
decontaminating solution without getting the cable connections wet. Dry the unit and put it back
in the drawer. Reconnect the 2 cables (push the flat cable to the back so that the handles close)
and screw the thumb screw back on the bottom of the products drawer.
" Push the drawer shut.
4.4.7 Cleaning the measurement plate

" Click the
icon,

" Remove all debris from every measurement cell and from every incubation cell.
" Clean every measurement cell and every incubation cell with cotton swaps slightly moistened
with ethanol (concentration between 20% and 40%). Do not use acetone or trichloroethylene.
" Clean the black cover for the measurement plate with a cloth or paper towel slight moistened
with hot water, and then wipe it with a dry cloth. Do not use ethanol on the measurement plate.
Avoid water overflowing into the measurement and incubation tracks on the measurement plate.

4.4.8 Cleaning the suction tip

Purpose: To avoid accumulation of dirt inside the suction tip and limit grip errors
4-13
0931634-NT - October 2007
Maintenance
" Click the
REFERENCE MANUAL
icon,

" Place the arm with the suction tip mounted on it to its upper position and bring it to the front of
the analyzer.
" Clean the suction tip with hot water.
" Dry it.
4.4.9 Cleaning the conveyor belt (shuttle transporter)

Purpose: To allow optimal circulation of the shuttles
" Click the
icon,
" Click the Maintenance button to run both shuttle transporter belts.
" Clean both shuttle transporter belts with a cloth slightly moistened with ethanol (concentration
between 20% and 40%).
Do not force the cloth or paper towel under the belt.
Note: If plasma is on the conveyor belt, it should be cleaned using the decontaminating solution.
4-14
0931634-NT - October 2007
REFERENCE MANUAL
Maintenance
4.4.10 Cleaning the shuttles

Clean the shuttles with ethanol (concentration between 20% and 40%); leave them to dry and put
them back on the analyzer.
4.5 Monthly preventive maintenance

4.5.1 Changing Teflon tips of the syringes
Monthly preventive maintenance
Purpose: To ensure optimal pipetting in each arm and to avoid leaks.
Ref.: 27530 (corresponds to 6 Teflon tips and 6 O-rings)
You should proceed with this change on a monthly basis; however this frequency may not be
adapted to the laboratorys activity. Nonetheless, you will take care not to exceed the limits
managed by the software.
If any syringe is to be replaced, do not use syringes other than those provided by Diagnostica Stago
(Ref.: 27538); this would produce incorrect results.
" Click the
icon,

" Click the Tip/Syringe tab.
The message "Choose a Teflon tip or syringe to replace..." is displayed.
" Click the

button,
The message "You have selected number x
For this operation, you must have:
- a new Teflon tip
- or a new syringe" is displayed.
" Take a new tip or a syringe; then click
,
The message "Arm is moving towards washing wells and wells are emptied." is displayed.
When the arm is in position, the second message "Press OK to continue." is displayed.
" Click
,
The message "P-Axis being reset..." is displayed.
Then the extra message "Press OK to continue." is displayed.
4-15
0931634-NT - October 2007
Maintenance
REFERENCE MANUAL
" Click
,
The message "You can change the Teflon tip or the syringe according to the procedure
described in the operators manual. When this operation is finished, validate by
pressing OK." is displayed.
" Open the upper left door.
" Unscrew the thumb screw (top of the syringe) on syringe n1. Syringe n1 is on the right.
" Take the syringe out of its clamp.

" Take the plunger out of the syringe.
" Remove the O-ring.
" Remove the Teflon tip with a sharp tool.
" Put the new tip on a flat surface and push the syringe plunger completely into the new tip.
Make sure you keep the tip upright during this operation.
" Insert the Teflon tip into distilled water.

" Draw the plunger back up into the syringe.
" Put the O-ring back in place.
Forgetting to put the O-ring back will lead to incorrect results.
" Put the syringe bottom back into the clamp, making sure you keep the syringe vertical.
" Manually screw the syringe back onto its support, making sure you keep it vertical.
" Put the plunger of the syringe back into upper position.
" Click
,
The message "Reservoir filling in progress..." is displayed; the intermediate STA-Cleaner
Solution reservoir fills up and the second message "Press OK to continue." is displayed.
" Click
,
The message "In order to check the circuit, a purge is performed. Validate by pressing
OK. Press OK to continue." is displayed.
4-16
0931634-NT - October 2007
REFERENCE MANUAL
Maintenance
" Click
,
The message "Circuit purge in progress. Please wait..." is displayed. The circuit is purged.
Meanwhile, pay attention to the syringe and check for any leaks. When the purge has finished, the
second message "Press OK to continue." is displayed.
" Click
,
The message "Home position in progress..." is displayed; the arm moves to its home position;
then the second message: "Press OK to continue." is displayed.
" Click
,
The message "If a problem occured during circuit purge, please perform the process
again." is displayed.
" Click
,
Return to the screen to choose a tip.
" If necessary, run another purge.
If not, proceed with changing tip n2 and tip n3 by clicking their respective icons,
and by positioning each syringe correctly; see above photo.
" Click
or

4.6 Quarterly preventive maintenance

4.6.1 Replacing air filters
Quarterly preventive maintenance
Ref.: 38517, main air filter
Ref.: 38125, optic module filter
" Click the
icon,
" Click the User Maintenance tab.

4-17
0931634-NT - October 2007
REFERENCE MANUAL
Maintenance
" Remove the main air filter from the optic module: open the lower right door and pull on the black
cover.
" Throw out the 2 filters.
" Insert the air filters, paying attention to assembly orientation: On the main air filter, the arrow
should be pointing towards the top of the analyzer.
" Exit maintenance by clicking
" Restart the STA-R Evolution.
4.6.2 Replacing the bar code reader wheel

Purpose: Avoid accumulation of dirt. If necessary, the wheel rotates the tubes to ensure that the bar
code reader correctly identifies them.
Ref.: 38698, black tube rotating wheel (x2)
Ref.: 39134, silicon tube rotating wheel (x2)
Ref. 38698
" Click the
Ref. 39134 (silicon wheel)
icon,
4-18
0931634-NT - October 2007
REFERENCE MANUAL
Maintenance

" Open the access door for the bar code reader.
" Remove the pin manually or using the flat screwdriver in the accessories toolkit; if you use the
screwdriver, put it between the pin and the axle of the tube rotating wheel and use it as a lever:
disengage the pin and pull it gently upwards.
" Remove the cover and then the tube rotating wheel.
Flange
Wheel
Pin
Axle
" Insert another tube rotating wheel.

" Put the cover back in place.
" Insert another pin by hand or using the flat screwdriver.
4-19
0931634-NT - October 2007
Maintenance
REFERENCE MANUAL
4.7 Curative maintenance

4.7.1 Cleaning the racks
Purpose: To ensure rack cleaning when the racks have been contaminated (plasma...).
" Leave the polypropylene racks that have been loaded to soak in a basin filled with a solution of
detergent and water (for example, a 4.8% solution of sodium hydroxide) for 10 minutes.
" If you use pediatric racks or micro-container racks, do not remove the adaptors when you carry
out cleaning.
Note: If a tube in the rack has been broken, you must decontaminate the rack using decontaminating
solution (see procedure in chapter 4.9.2 of this manual).
You should not use a chlorine bleach solution on a regular basis (except where a tube in the rack has
been broken) or ethanol (concentration between 20% and 40%).
4.7.2 Cleaning the rack conveyor

Purpose: To decontaminate the rack conveyor if a rack is tipped leading to spillage, or if a tube
breaks.
4-20
0931634-NT - October 2007
REFERENCE MANUAL
Maintenance
" Turn off the STA-R Evolution, see procedure in chapter 3.11.1 of this manual.
" Open the transparent cover as well as the access door to the tube rotating wheel.
" Use the decontaminating solution to clean the rack conveyor, the belts and if necessary the tray.
" Turn the STA-R Evolution back on.
4.7.3 Cleaning the Cuvette loader

Purpose: Restore normal operation of the cuvette loader when cuvettes are stuck in the loader or
broken.
" Click the
icon,
Take up reel
Cuvette feed button
Cuvette loader trap
" Lift the maintenance handle of the take up reel (point n1 in the photo above).
" Remove the take up reel by sliding it along its axis of rotation.
" Open the cuvette loader trap (point n3 in the photo above).
" Lift the maintenance handle for the roll.
" Remove the roll by sliding it along its axle.
" Dispose of any cuvettes or foam in the cuvette loader.
" Put the roll back in place and position it so the roll is on the left and the take up reel is on the right.
" Slide the roll along its axis of rotation and lower the rolls maintenance handle.
" Slide the take up reel along its axis of rotation and lower the take up reels maintenance handle.
" Put the film into the cuvette loader so that it is parallel to the loading rails.
4-21
0931634-NT - October 2007
Maintenance
REFERENCE MANUAL
" Close the cuvette loader trap.
Do not twist the film.
" Press the button beside the take up reel (point n2 in the photo above) to start feeding the
cuvettes.
" Check whether the cuvettes enter the cuvette loader without twisting sideways, and keep
pressing the feed button until the cuvettes have been completely inserted into the loader.
4.7.4 Cleaning the bar code reader wheel

Purpose: To restore correct operation of the wheel if there is an accumulation of dirt (e.g. ink, glue).
" Click the
icon.

" Open the access door to the tube rotating wheel.
" Remove the clip manually or using the flat screwdriver in the accessories toolkit. If you use the
screwdriver, put it between the clip and the axle of the tube rotating wheel and use it as a lever.
" Remove the flange and then the tube rotating wheel.
4-22
0931634-NT - October 2007
REFERENCE MANUAL
Flange
Wheel
Clip
Axle
Maintenance
" Carefully clean the wheel using a soft cloth moistened with ethanol (concentration between 20%
and 40%).
" Put the wheel, the cover and finally the clip back into place.
" Close the access door for the bar code reader.
4.7.5 Cleaning the window of the samples and products bar code readers
Purpose: Restore the correct operation of the samples and products bar code readers if bar codes
are not being read.
" Take a cotton swap and moisten it with ethanol (concentration between 20% and 40%).
" Carefully clean the bar code reader window.
4-23
0931634-NT - October 2007
REFERENCE MANUAL
Maintenance
4.8 Replacing components

4.8.1 Replacing a needle
If the analyzer is equipped with a plug piercing needle, replacing the needle requires carrying out a
specific servicing procedure; refer to the procedure described in the Cap piercing option manual
(ref 0931239x).
Ref.: 39249 (for the standard n1 needle)

Ref.: 39250 (for needle n2)
" Click the
icon,

" Click the Ndle Repl tab.
The message "Choose a needle to replace..." is displayed.
" Click the
button, the
or the
button depending on which needle is to be replaced.
The message "You have selected number x.

- a new needle
- the mapping cuvette" is displayed. x corresponds to the number of the needle to be changed.
" Take a new needle that has a reference that matches the needle that is to be changed and the
mapping cuvette (this is provided with the analyzer); then click
The message "Home position in progress..." is displayed.

Arm n1 (n2 or n3) moves to its home position; then when it is finished, the second message
"Press OK to continue." is displayed.
" Click
The message "Arm is moving..." is displayed; the arm moves towards the front of the analyzer.
When the arm is in position, the extra message "Press OK to continue." is displayed.
" Click
The message "Once the cover is opened, you can change the needle according to the
procedure described in the operators manual. When done, insert the mapping cuvette
and validate by pressing OK." is displayed.
4-24
0931634-NT - October 2007
REFERENCE MANUAL
Maintenance
" Open the products drawer manually.
regulations in force locally: wearing disposable gloves and disposal procedure (see below).
Removing the needle n1 and the needle n2

" On the lower level of the needle bearing unit, completely unscrew the knurled nut.
" Remove this nut.
Legend:
Needle
Knurled nut
" Unscrew the connection a rotation (or at most a rotation).
" Disconnect the connecting tubing.

" Lower the needle-tubing unit.
" Remove the needle-tubing unit.
- Needle equipped with black knurled nut:
" Dispose of the knurled nut and of this needle in accordance with the regulations in force locally
for sampling needles.
- Needle equipped with a yellow knurled nut:
4-25
0931634-NT - October 2007
REFERENCE MANUAL
Maintenance
" Reuse the yellow knurled nut.
Reassembly of the needle n1 and the needle n2
" Push the needle tube into the tubing so that it abuts this tube.
" Check that the tubing is not caught in the needle tube.
" Completely screw back the knurled nut by hand.
" Insert the tubing in the sheathing in the chain and set it along its path.
" Reconnect the tubing to the connection and screw it back on.
Removing the needle n3
Do not disconnect the tubing on the upper level of the head.
" Completely unscrew the knurled nut on the lower level of the needle tube.
" Remove this nut.
" Lower the needle until the heating tube appears.
" Disconnect the needle-tubing from the heating tube.
Reassembly the needle n3
" Push the heating tube into the needle tubing so that it abuts this tube.
Reassembly of needle n3
" Push tthe needle tube into the needle tubing so that it abuts this tube.
4-26
0931634-NT - October 2007
REFERENCE MANUAL
Maintenance

Checks to be performed independently of needle type
" Check the position of the tubing and the cables on the upper level to avoid hindering arm
movement.
" Check the connection of the level detection cable from the point where it comes out of the
needle tube to the electronic card.
" Remove the metal mandrel from the needle and keep it to clean or unclog the needle.
" Put the mapping cuvette in a shuttle at the sample station (needle n1) or at the reagent station
(needle n2) or in the measurement cell (needle n3).
" Close the products drawer manually.
" Click
and validate by pressing OK." and then "Autodetection not active" are displayed.
" Click

Arm n1 (n2 or n3) moves to its home position; then when it is finished, the extra message
"Continue... Press OK to continue." is displayed.
" Click
The message "Setting of the mapping position:

- Adjust X and Y with the arrow buttons
- Manually adjust Z
Continue..." is displayed.
" Manually lower the specific needle tube to see if the needle can penetrate the hole in the mapping
cuvette. If necessary, click one or more arrows until the needle can freely penetrate the hole in
the mapping cuvette. Then insert the needle right to the bottom of the central hole in the
mapping cuvette.
" Click
The message "Continue..." is displayed.

" Click
The messages "Z being recalculated", "X being recalculated" and "Y being recalculated"
are displayed one after the other and then disappear.
" Click
" The message "Press OK to continue." is displayed.

" Click
" The message "The procedure was successful." is displayed.

" Click OK
4-27
0931634-NT - October 2007
REFERENCE MANUAL
Maintenance
Return to the choice of the needle that has to be changed.

" Lift the transparent cover
" Recover the mapping cuvette.
" Close the transparent cover
" Run a purge on the needle that has been changed.
" Click

4.8.2 Replacing the suction tip

Ref.: 39163 (delivered in sets of 2)
" Click the
icon,

" Click the Suction tab.
The message "Press the suction tip button..." is displayed.
" Click the
button.
The message "For this operation, you must have;

- a new suction tip
" Take another suction tip; then click

The suction tip arm auto-zeroes; then when it is finished, the next message "Press OK to
" Click
The message "Arm is moving towards the front of the STA-R" is displayed; the arm moves
to the front of the analyzer.
" Remove the suction tip by pulling it down.
4-28
0931634-NT - October 2007
REFERENCE MANUAL
Maintenance
" Dispose of the suction tip and the gloves used to remove the suction tip. Use new gloves to insert
the new suction tip.
" Put the new suction tip in soapy water (to facilitate its insertion), dry it and insert it: it should abut
the suction tip support.
" Dry the suction tip.
" Click
The message "You have replaced the suction tip. Please close the cover in order to run
automatic tests." is displayed.
" Close the transparent cover and click
The message "Home position in progress..." is displayed. The suction tip arm moves to its
home position; then when it is finished, an additional message "Press OK to continue." is
displayed.
" Click
" Click
4.8.3 Replacing the lamp

Ref.: 26699, Halogen Lamp
" Click the
icon,

" Click the Lamp tab.
The message "Press the lamp replacement button..." is displayed.
" Click the
button.
The message "For this operation, you must have:

- a new halogen lamp
" Take another lamp; then click
" The message "When you have replaced the lamp, please validate in order to perform a
photometric test." is displayed.
" Open the lower right door.
The lamp stand as well as the lamp may still be hot; let them cool off.
" Unscrew the thumb screw by hand to be able to remove the small flap.
4-29
0931634-NT - October 2007
Maintenance
REFERENCE MANUAL
" Lower the lamp stand, pushing back the tubing if necessary.
" Hold the lamp stand down. Remove the used lamp from its stand with the other hand, protecting
it with a piece of paper of a dry cloth to avoid burns or possible injury.
" Take the new lamp.
Do not touch the new lamp directly; use a piece of paper or a dry cloth.
" Lower the lamp stand, pushing back the tubing with one hand if necessary. Hold it down. Place
the new lamp in its holder with your other hand.
" Gently release the lamp stand
" Put the flap back in place.
" Put the thumb screw back on.
" Close the lower right door.
" Click
The photometry test is run. Meanwhile, the message "Lamp Test in progress, please wait..."
is displayed.
When the test is finished, the second message "Press OK to continue." is displayed.
" Click
The message "Halogen Lamp OK" is displayed.

" Click
4.8.4 Replacing main fuses

Ref.: 26681 - 6.3 A T 5x20 (set of 10 delayed 6.3A fuses for the STA-R Evolution 230V)
Ref.: 26694 - 15 A T 6.3x32 (set of 10 delayed 15 A fuses for the STA-R Evolution 100/115V)
This operation should be done with the analyzer turned off.
The main fuses are located in two compartments above the On/Off switch to the right of the STA-R
Evolution.
4-30
0931634-NT - October 2007
REFERENCE MANUAL
Maintenance
" Turn the On/Off switch to Off (green indicator off).

" Unplug the mains cable.
" Put a screwdriver into the gap in the fuse housing; unscrew the housing completely (in the
direction indicated by the arrow, from right to left); the housing will disengage.
" Remove and replace each fuse with a fuse of the same amperage: 6.3A for the STA-R Evolution
230V or 15A for the STA-R Evolution 100/115V, read the references carefully; see above.
" Put each fuses housing back in place and screw them in completely (opposite direction to that
indicated by the arrow, from left to right).
" Plug the mains cable in again (check that the switch is turned to Off).
" Turn the On/Off switch to On (green indicator on).
4.8.5 Replacing secondary fuses
STA-R Evolution 115V / 100V
STA-R Evolution 230V
Reference
Set of 10 fuses
Reference
Set of 10 fuses
39880
1 A T 5x20
39880
1 A T 5x20
26682
2 A T 5x20
26682
2 A T 5x20
26684
5 A T 5x20
26684
5 A T 5x20
26681
6,3 A T 5x20
26681
6,3 A T 5x20
39863
10 A T 5x20
26694
15 A T 6.3x32
26694
15 A T 6.3x32
4-31
0931634-NT - October 2007
Maintenance
REFERENCE MANUAL
The 15 A fuse is larger than the other fuses and has a different aspect.
This operation should be done with the device turned off.
The secondary fuses can be found by opening the lower left door of the STA-R Evolution.
LED on: the fuse is operational
LED off: the fuse needs to be changed.

" Open the lower left door.
" Put a screwdriver into the aperture of the housing for the fuse to be changed; press strongly and
turn the screwdriver a quarter circle in the direction of the arrow (from right to left): the fuse
housing is disengaged.
" Remove and replace each fuse with a fuse of the same amperage: The fuse values are given beside
their housings; see photo above (pay careful attention to references; see above).
" Put the fuse housing back in place by pressing strongly and turning in the opposite direction to
the one the arrow indicates (from left to right).
" Close the lower left door.
4-32
0931634-NT - October 2007
REFERENCE MANUAL
Maintenance
4.9 Decontamination
4.9.1 Decontamination procedure
Note: In accordance with the recommendations of the S.F.R.L. (Syndicat des Fabricants de Ractifs
de Laboratoire: Societe of Manufacturers of Laboratory Reagents) relative to people who work in
contact with biological products that may present risks (biohazards), you must proceed with
decontamination of the STA-R Evolution system, following the procedure described above, prior
to any intervention by a representative (in particular by an After-Sales Service technician) or by a
transporter designated either by Diagnostica Stago, or by one of their official distributors.
Decontaminate the following parts:
-
The products drawer,
The measurement plate,
The rinsing wells,
The conveyor belts,
The rack conveyor,
The needles,
The mandrel.
4.9.2 Preparation of the decontaminating solution

Chlorine bleach is usually merchandised as follows:
-
Chlorine bleach in a 1 litre container with 2.6% active chlorine,
Extract of chlorine bleach in 250 ml single serving packages with 9.6% active chlorine.
The 9.6% solution must first be diluted to , that is 1 part of 9.6% bleach to 3 parts of water to
obtain a 2.6% chlorine bleach solution.
" Mix 1 part 2.6% chlorine bleach with 6 parts water. This gives 2.6% chlorine bleach diluted to 1/
7 that is 0.37% chlorine in the end.
4.9.3 Decontaminating the mandrel

" Put the mandrel into the decontaminating solution.
" For the solution to act, leave the mandrel in it for 30 minutes,
" Remove the mandrel; rinse it and then dry it.
4-33
0931634-NT - October 2007
REFERENCE MANUAL
Maintenance
4.10 Maintenance utilities
Diagnostica Stago is not liable in case of contamination and/or users hardware or software
dysfunction resulting for example from the use of floppy disks or any other material, and more
particularly during savings and/or data files transmission, such as the ones described of this manual.
4.10.1 Printing the bar codes

Purpose: To print a page of bar codes from the STA-R Evolution, that is 65 bar code labels.
-
Type of bar code printed: 2 out of 5 interlaced
Type of label recommended: 7810 (3 M)

- acrylic adhesive, matte white polyester support
- cutting the label: rounded ends to avoid lifting.
" Click the
icon,
" Click the
button.
" Enter the first number in the bar code (Beginning of the series).
" Enter the number of pages of bar codes to be printed.
" Enter the incremental value of the bar code.
Note: The Number of Digits area is automatically updated from the incremental value of the bar
code.
" Check printer setup using the
" Click the
button; change setup if necessary.
icon,
Printing a page of bar codes.

" Click the
button.
Note: Before sticking the label on the tube, make sure that:
-
the tube is clean,
the manufacturing date of the label to be glued is less than 1 year ago,
the label should be applied perpendicular to the axis of the tube and the figures should read from
bottom to top,
if there is already a label on the tube, the new label should completely hide the bar code on the
old label.
4-34
0931634-NT - October 2007
REFERENCE MANUAL
Maintenance
4.10.2 Backing up data

Purpose: enable the user to save:
- the test methodologies as well as the calibrations and the associated quality controls,
- the error messages,
- the archives relating to the patient (results, identities,).
Note: The system settings will be backed up systematically.
This back-up operation may last a long time.
" Click the
icon,
" Click the
button.
" Click either the checkbox or the description of the item to select the items to be backed up.
" Select the storage medium (only if a CD/DVD recorder is installed on the analyzer. If not, go to
the rest of the procedure in chapter 4.10.2.1):
-
Back-up on diskettes
Back-up on CD/DVD
, see the rest of the procedure in chapter 4.10.2.1

4.10.2.1 Backing up data on diskettes

The number of diskettes required for the back-up is indicated.
" Click the
button.
The following messages are displayed:

"Info about this Backup executed at:
Date/Time"
"Insert a new floppy disk
ATTENTION!! Use a pre-formatted blank floppy disk
Number of blank disks expected: x "
" Insert an unused, formatted diskette and click
to confirm.
The following message is displayed when the diskette is full:

then Click on Ok".
" Insert a diskette into the drive.
4-35
0931634-NT - October 2007
Maintenance
" Click
REFERENCE MANUAL
to confirm.
" Wait until the message "Backup is complete." is displayed.

" Click
to confirm.
" Remove the diskette from the drive and write down the following information:
Back-up Diskette DK/NbDK
STA-R Evolution Nxxxx
software version: y.yy
date"
where:
- DK is the diskette number,
- NbDK is the number of diskettes used for this back-up,
- xxxx the serial number of the analyzer.
- y.yy the main software version of the analyzer
" Click the
button.
Note: Work with 2 sets of back-up diskettes: one used in even numbered weeks, the other in odd
numbered weeks.
4.10.2.2 Backing up data on CD/DVD

(only if the analyzer is equipped with a CD/DVD recorder)
" Keep the lower left side door open during the whole procedure.
" Insert a CD-R, a CD-RW or a DVD-R.
" Click

Info about this Backup executed at:
xx/xx/xx xx:xx
The Burner window is displayed.
" Click
" Wait for the message Burn succeed... to be displayed.

" Click
to confirm.
The Burner window is closed.

The CD/DVD is ejected.
The data is saved in the STABCK.zip file and in the EntetelD.txt file.
This data is located in D:\BackUpRestore\yyyy-mm-dd-hh-mm.
Write the main software version on the CD/DVD and the serial number of the analyzer.
Do not use this CD/DVD on another analyzer or with another software version.
4.10.3 Restoring of data

4-36
0931634-NT - October 2007
REFERENCE MANUAL
Maintenance
Purpose: enable the user to restore data from diskette:

-
the test methodologies as well as the calibrations and the associated quality controls,
the error messages,
the archives,
the system settings,
This restoring operation writes over the data in the selected files on the hard drive.
" Click the
icon,
" Click the
button.
" Click the Restore tab.

" If a CD/DVD recorder is installed:
Select the type of storage medium:
-
Restoring data from diskettes
Restoring data from CD/DVD
" Insert the medium to be restored.
Make sure that the serial number and the software version on the back-up diskette are identical to
the ones on the analyzer.
Restoring data from diskettes:
" Click

Insert the last floppy disk of set
" Insert in the driver the first diskette of the last back up to restore and click
to confirm.
" See the rest of the procedure hereafter.
4-37
0931634-NT - October 2007
REFERENCE MANUAL
Maintenance
-
Restoring data from CD/DVD (only if a CD/DVD recorder is installed):

The CD/DVD structure tree is displayed: the BackUpRestore folder is open.
The folders which might be restored appear, they are identified by the date and the
hour of their back-up.
" Double-click the file to restore.
" Click the
button that has appeared.
Only check the System configuration item if the hotline advises you to do so.
" Select the items to be backed up by clicking either the checkbox or the description of the item
and then click
to confirm.
If the Test configuration item is selected, the following message is displayed:

"Caution: This operation will erase the patients, product files and replace the current
test set up, calibrations and controls on board STAR.
Do you agree?"
If the Archives item is selected, the following message is displayed:
"Caution: This operation will erase the current archive file on board STAR.
Do you agree?"
If the System configuration item is selected, the following message is displayed:
"Caution: This operation will replace the current mapping, printing and transmission
parameters on board STAR.
Do you agree?"
" Click
to confirm each message; otherwise click
The data is restored and the following confirmation message is displayed:

"Restore complete".
" Click
to confirm.
" Remove the diskette, the CD or the DVD from the drive.
" Click the
button.
4.10.4 Back-up of results (use of TDex)

Purpose: To allow the user to back up the patient results, the associated calibrations as well as the
information related to the products used.
4-38
0931634-NT - October 2007
REFERENCE MANUAL
Maintenance
Note: The database allows you to back up the data for 600 patients. The patients who have been
deleted are not backed up by TDex. To back them up, you only need to reload them on board and
all the data on a given patient will be re-entered in the database and can be backed up.
The file on back-up diskette is a text file (.txt) that can be read by other applications (e.g. Excel).
" Click the
icon,
" Click the
button.
" Select the type of storage medium (only if a CD/DVD recorder is installed. If not, see the rest of
the procedure in chapter 4.10.4.1):
-
Back-up on CD/DVD

4.10.4.1 Backing up results on diskettes

" Insert a blank and formatted diskette then click
" Enter the new name for the file.

Creating a FILE NAME.txt file that may be read and used in other applications.
Note: If there isn't a diskette in the drive, click Open another file.
" Click Save.
The Comments window appears.
" Enter the comments if necessary, and then click OK.
Note: You can enter 5 lines of comments, which can include up to 75 characters per line (including
spaces).
" Click the
button.
4.10.4.2 Backing up results on CD/DVD

(only if a CD/DVD recorder is installed)
" Click the
button.
The Comments window is displayed.

" Enter the comments if necessary, then click OK.
Note: You can type 5 lines of comments, each line may contain up to 75 characters (75 characters
including spaces).
4-39
0931634-NT - October 2007
REFERENCE MANUAL
Maintenance
" Click

" Click
to confirm.

The data are saved in a file called ddmmyyyy.txt.
This file is located in D:\TDEX\yyyy-mm-dd-hh-mm.
" Click the
button.
4.10.5 Remote link

Purpose: To allow the hotline to carry out telemaintenance operations.
This procedure is only possible if PC Anywhere is installed and should only be carried out at the
request of your telephone support.
At any time and from any menu that you are in, you can run the PC Anywhere utility; to do this:
" Check whether the MODEM is on and connected to the dedicated telephone line for the STA-R
Evolution. If not, turn it on and connect it.
" Simultaneously press the following keys: Ctrl + Alt +F5
The connection will be established.
You can also make the connection by following the procedure below:
" Click the
icon,
" Click the
button.
The PC Anywhere utility is automatically run and the following screen is displayed:
4-40
0931634-NT - October 2007
REFERENCE MANUAL
Maintenance
" Double click the STA-R icon.

The Maintenance screen appears again. From then on, the hotline can be connected to the
analyzer to carry out telemaintenance operations.
You should make this connection secure either:
-
by turning on the MODEM only when necessary,
by protecting access to your analyzer with a password defined in PC Anywhere,
by combining both security procedures described above.
4.10.5.1 Define or change a password in PC Anywhere

Purpose: To secure your analyzers remote connection.
" Click START in the taskbar (at the bottom of the screen).
(If the taskbar does not appear on the screen, simultaneously press Ctrl + Alt + B to display it.)
" Click Programs, pcAnywhere and then Symantec pcAnywhere.
" Using the right button of your mouse, click the STA-R button.
" Click Properties.
4-41
0931634-NT - October 2007
Maintenance
REFERENCE MANUAL
" Click the Callers tab.

" Using the right button of your mouse, click STAGO.

" Click Properties.
4-42
0931634-NT - October 2007
REFERENCE MANUAL
Maintenance
" Enter the callers identification (in the Login Name text box) and the password (in the Password
text box).
" Cick
to confirm.
To define a password through the STAR Maintenance utility, follow the procedure below:
" Click the
icon,
" Click the
button.
" Click the STA-R button and then right click under the Touchpad.
" Select Properties
The following screen appears:
4-43
0931427D - October 2007
Maintenance
" Click the
REFERENCE MANUAL
tab

" Click Properties.
4-44
0931634-NT - October 2007
REFERENCE MANUAL
Maintenance
" Enter the callers new password, and then validate it using the
key.
key.
4.11 Description of the User Menu
4.11.1 Export CQ
4.11.1.1 Export the quality controls

" Click the Export CQ button.
4-45
0931634-NT - October 2007
REFERENCE MANUAL
Maintenance
The following window appears (only if the analyzer is equipped CD/DVD recorder):
" Click the Export Excel tab.

" If a CD/DVD recorder is installed:
Select the type of storage medium:
" Back-up on CD/DVD
" Back-up on diskette
" Insert the medium.
" Click the Select Date Range button.
" Select the period you want using the

" Click
and
arrows.
" If necessary, enter a date range.

" Check the Check All Test checkbox or select the required methodologies using Windows multiselection (Ctrl + mouse or
+ mouse).
" Click the Execute your request... button.

A window that indicates the number of entries found appears:
4-46
0931634-NT - October 2007
REFERENCE MANUAL
" Click
-
Maintenance
to confirm.
Back-up on diskette:
A progress window is displayed.
" Click
The data is saved directly on the diskette with Excel format.

Note: By clicking the Other tab, the last exported file may be displayed.
-
Back-up on CD/DVD (only if the analyzer is equipped with a CD/DVD recorder):

" Click

" Click

A progression window is displayed
" Click
The data is saved in a file called ddmmyyyy.txt.
This file is located in D:\ExportCQs\yyyy-mm-dd-hh-mm.
Note: By clicking Other, the last exported file may be displayed.
The data will be saved directly on the diskette in Excel format.
Note: When you click the Other tab, you view the last file exported.
4.11.1.2 View all the quality controls in the database

When you click the CQ Results tab, you can view all the data in the database related to the quality
controls.
4-47
0931634-NT - October 2007
REFERENCE MANUAL
Maintenance
4.11.1.3 Deleting quality controls

You can purge the database for a given period of time.
" Click the Delete tab.
" Click the Select Date Range button and use the arrows to select the period of time you want.
The number of saves that can be deleted is displayed.
" Confirm the deletion by clicking
4.11.2 Printing the patient files

The Customized Printout button allows you to customize printing an archived or on board patient
files (see procedure in chapter 3.7.11.3 of this manual).
4.11.3 Delete lot

" Click the Delete Lot button,
4-48
0931634-NT - October 2007
REFERENCE MANUAL
Maintenance
" Click the number of the lot to be deleted,

" Click the Delete this lot button,

" The message
"Confirm delete lot n
and calibrations" is displayed,
" Click
The lot number is deleted from the list.

" Click
to return to the User Menu.
4-49
0931634-NT - October 2007
Maintenance
REFERENCE MANUAL
4.11.4 Archives Export

" Click the Archives Export button.
" Click Files and then Open.

" Select the file containing the archived data to be viewed.
" Select the period to be viewed.
" Select the test(s) to be viewed.
" Click the GO button,
The data are displayed from selected criteria.
" Select the destination to which to export the .xls file containing the archives displayed on the
screen:
-
Exportation on diskette, see the rest of the procedure in chapter 4.10.4.1
Exportation on CD/DVD (only if the analyzer is equipped with a CD/DVD recorder), see the rest
of the procedure in chapter 4.10.4.2
4.11.4.1 Exportation on diskette

" Click Files and then Export on Floppy/HD.
" Insert a diskette.
" Select 31/2 Floppy (A:) in the pull-down menu.
" Type a name for the file.
4-50
0931634-NT - October 2007
REFERENCE MANUAL
Maintenance
" Click
" Close the application (click the cross in the upper right corner of the screen).
4.11.4.2 Exportation on CD/DVD

" Insert a CD-R, CD-RW or DVD-R.
" Click Files then Export on CD/DVD.
" Enter a name for the file in the Filename field then click

" Click

" Click

The data is saved in a file called tdexarch.xls.
This file is located in D:\TDexArchive\yyyy-mm-dd-hh-mm.
" Click
4.11.5 Photo. graphics

" Click the Photo. Graphics button,
The following screen is displayed:
4-51
0931634-NT - October 2007
Maintenance
REFERENCE MANUAL
" Choose the test to be displayed,

" Click the Measure 1 or Measure 2 button,
4-52
0931634-NT - October 2007
REFERENCE MANUAL
Maintenance
" Click
to print the graphic.
" Click
to return to the measurements list.
4.11.6 Tracking menu

Note: the files older than 365 days are automatically deleted from the tracking file.
" Click the Tracking Menu button,
" Select the records to be displayed (by period and/or module).

" Select how to display the data:
-
chronological order
anti-chronological order
" Click the Export button to export the data,
4-53
0931634-NT - October 2007
REFERENCE MANUAL
Maintenance
The following screen appears (only if the analyzer is equipped with a CD/DVD recorder):
" Select the data display format:

-
series separated by commas
Excel table with column headings
" Select the destination for the data to be exported:

-
Exportation on diskette
Exportation on CD/DVD


" Click the Go button.
The progress of the export is displayed on the screen.
The message Insert a formated disk nx is displayed.
to confirm.
" The message Export procedure stopped is displayed.

" The data are saved in the "BackupDate".txt file.
" Once the export procedure is finished, click

" Insert the CD-R, CD-RW or DVD-R.
4-54
0931634-NT - October 2007
REFERENCE MANUAL
" Click
Maintenance

" Click

The message "Export procedure terminate on D:\Tracking\aaaa-mm-jj hh-mm" is
displayed
" Click
The data is saved in a file called "BackupDate".txt.

This file is located in D:\Tracking\yyyy-mm-dd-hh-mm.
4-55
0931634-NT - October 2007
Maintenance
REFERENCE MANUAL
4-56
0931634-NT - October 2007
REFERENCE MANUAL
Content
Detailed description of the software screens
5.1
How to read a screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
5.1.1
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
5.1.2
Function panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
5.1.3
System panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
5.1.4
System panel Icon list . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
5.1.5
General contents of a screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
5.1.6
Contents of a screen First line . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
5.1.7
Contents of a screen Selection tab . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
5.1.8
Contents of a screen Displaying a partially visible tab . . . . . . . . . . . . . . . . . 4
5.1.9
Contents of a screen Scroll bars . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
5.1.10
Contents of a screen Vertical scroll bar . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
5.1.11
Contents of a screen Horizontal scroll bar . . . . . . . . . . . . . . . . . . . . . . . . . 5
5.2
How to use a screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
5.2.1
Navigating through the software . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
5.2.2
Moving a column . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
5.2.3
Printing a screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
5.3
Display and use of the online help . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
5.3.1
Display the online help . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
5.3.2
Use the online help . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
5.4
Test Panel screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
5.4.1
Description of the Test Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
5.4.2
Horizontal scroll bar Control panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
5.4.3
Vertical scroll bar Control panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
5.4.4
Displaying additional information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
5.4.5
Displaying the list of patient files . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
5.4.6
Display modes for the patient file columns . . . . . . . . . . . . . . . . . . . . . . . . . 11
5.4.7
Displaying results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
............ 1
1
0931634-NT - October 2007
Content
REFERENCE MANUAL
5.4.8
Archives button Test Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
5.4.9
Search Button Test Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
5.4.10
Color codes on results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
5.4.11
Patient file identification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
5.4.12
File marker Test Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
5.4.13
Modalities for displaying results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
5.4.14
Rack number . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
5.4.15
Symbols used for the patient files in the Test Panel . . . . . . . . . . . . . . . . . . . 18
5.4.16
Symbols used for the tests in the Test Panel . . . . . . . . . . . . . . . . . . . . . . . . 18
5.5
Sample loading screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
5.5.1
Sample (Un)Loading screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
5.5.2
State of the tray . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
5.5.3
List of known racks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
5.6
Patient Acquisition . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
5.6.1
Patient Acquisition screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
5.6.2
Complete identification of a patient file . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
5.6.3
Test selection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
5.7
Product loading screens . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
5.7.1
Loading screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
5.7.2
List of products screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
5.7.3
Forecast screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
5.7.4
Drawer screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
5.7.5
Barcode label reading window . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
5.8
Calibration screens . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
5.8.1
General information about calibrations . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
5.8.2
Calibration curve . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
5.8.3
Test list Calibration screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
5.8.4
Products tab Calibration screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
2
0931634-NT - October 2007
REFERENCE MANUAL
Content
5.8.5
Table of points tab Calibration screen . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
5.9
Quality control screens . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
5.9.1
General principles for quality controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
5.9.2
Quality Control screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40
5.9.3
List of possible functions Quality Control screen . . . . . . . . . . . . . . . . . . . 41
5.9.4
Test list Quality Control screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
5.9.5
Information on the level of the quality control . . . . . . . . . . . . . . . . . . . . . . . 42
5.9.6
Definition of the terms used Quality Control screen . . . . . . . . . . . . . . . . 43
5.9.7
Graphical displays . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
5.9.8
Numeric information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
5.10
Patient File screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50
5.10.1
Patient File screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50
5.10.2
Writing a note . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51
5.10.3
Dates - Patient File screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51
5.10.4
Limits - Patient File screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51
5.10.5
Raw measurement - Patient File screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51
5.10.6
Status of the results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52
5.10.7
Test/Result/Status Patient File screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52
5.11
Test setup screens . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52
5.11.1
General information on the test configurations . . . . . . . . . . . . . . . . . . . . . . 52
5.11.2
Methodology tab Test setup screens . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54
5.11.3
Results tab - Test setup screens . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60
5.11.4
Calibration tab Test setup screens . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68
5.11.5
Printout/Transmission tab - Test setup screens . . . . . . . . . . . . . . . . . . . . . . 74
5.11.6
Quality Controls tab - Test Setup screens . . . . . . . . . . . . . . . . . . . . . . . . . . 76
5.12
Global Options screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79
5.12.1
Global Options screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79
5.12.2
Titles 1 and 2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79
3
0931634-NT - October 2007
Content
REFERENCE MANUAL
5.12.3
Languages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 80
5.12.4
File Entry: Parameter for patient file acquisition . . . . . . . . . . . . . . . . . . . . . 80
5.12.5
Miscellaneous . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81
5.12.6
Arbitrary Units . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 82
5.13
Communications screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 83
5.13.1
Communications screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 83
5.13.2
The number of trials should there be an error . . . . . . . . . . . . . . . . . . . . . . 84
5.13.3
Station number . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 84
5.13.4
Protocol type . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 84
5.13.5
Transforming the character . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 84
5.14
Passwords screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 85
5.15
Status - Counters screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 86
5.15.1
Temperatures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 86
5.15.2
Level detection management . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 86
5.15.3
Versions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 87
5.15.4
STAR serial number . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 87
5.15.5
Timer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 87
5.15.6
Suction pad . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 87
5.15.7
Availability before maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 87
5.15.8
Cuvettes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 87
5.15.9
Cleaner Solution . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 88
5.16
CD/DVD recorder screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 88
4
0931634-NT - October 2007
REFERENCE MANUAL
Detailed description of the software

screens
5 Detailed description of the software screens

5.1 How to read a screen
5.1.1 Introduction
All the screens of the STA-R Evolution are displayed in the same way.
5-1
0931634-NT - October 2007

screens
REFERENCE MANUAL
5.1.2 Function panel

The function panel is always displayed at the top of the screen.
Clicking an icon displays the corresponding menu:
Display the screen for righthanded or left-handed users
displays the Patient menu
displays the Products menu
displays the Calibration

menu
displays the Quality Control

menu
displays the Setup menu
displays the contextual help
displays the STAT menu
displays the Maintenance

menu
5.1.3 System panel

The system panel is always displayed at the bottom of the screen.
Clicking an icon displays the function that corresponds to it:
At the bottom left, the software version number is displayed with patch identification if need be.
In the left window, information on the system is displayed:
-
the number of racks on board,
the number of tubes on board,
the number of cuvettes available on the reel.
The current date and time are displayed on the right part of the screen.
5-2
0931634-NT - October 2007
REFERENCE MANUAL

screens
5.1.4 System panel Icon list
is displayed and flashes when

a calibration is to be validated
or is erroneous

or is erroneous

a test is blocked due to lack of
product (reagent, control or
calibrator)

the samples are blocked
(insufficient Desorb, manual
blocking of samples etc.)

because of lack of calibration

the photometric tests are
blocked because of detection
of an error in photometry
restart the analyzer
emergency shutdown
exit system
printing
displays the control screen

(cuvette counter,
temperatures, level detection
etc.)
5.1.5 General contents of a screen

Aside from the function panel and the system panel, which are always displayed at the top and the
bottom of the screen, the central area of the screen changes depending on the menu selected.
The principles behind consulting data are the same for all screens.
The data specific to each screen is described in the sections dealing with the screen.
5.1.6 Contents of a screen First line

Identification of the currently displayed menu.
This menu has been selected using one of the icons in the function panel.
5-3
0931634-NT - October 2007

screens
REFERENCE MANUAL
5.1.7 Contents of a screen Selection tab

Clicking the name of a tab provides access to a sub-menu.
5.1.8 Contents of a screen Displaying a partially visible tab
Click on the arrow to completely display the tab.
5.1.9 Contents of a screen Scroll bars

Using the scroll bars, you can move through the list of displayed elements:
-
upwards or downwards, vertical scroll bar,
to the right or to the left, horizontal scroll bar.
5.1.10 Contents of a screen Vertical scroll bar
moves cursor one notch up
moves cursor to the desired location
displays the following screen
moves cursor one notch down
5-4
0931634-NT - October 2007
REFERENCE MANUAL

screens
5.1.11 Contents of a screen Horizontal scroll bar
moves the cursor one notch to the left
moves the cursor to the desired location
moves the cursor one notch to the right
5.2 How to use a screen

5.2.1 Navigating through the software
To find out how to navigate through the software and access the various screens (loading, calibration
etc.), click the buttons and the elements that correspond to them.
" Click the buttons displayed on the screen by pressing the touch screen with your finger or using
the pointer provided for this purpose.
Note: Do not use any other object to click an element on the screen.
5.2.2 Moving a column

" Access the screen you want by clicking one of the icons in the function panel and then clicking the
appropriate tab.
" Touch the header of the column to be moved.
" Maintain pressure on the header while moving it to the position where you want it to be.
5.2.3 Printing a screen

You can print the displayed screen or save it as an image using the Print Screen key.
"
"
"

Simultaneously press Ctrl + Alt + X if the analyzer is equipped with a CD/DVD recorder,
Simultaneously press Ctrl + Alt + DEL if the analyzer is not equipped with a CD/DVD recorder,
Click Task manager,
The system management icons appears at the top of the screen.
5-5
0931634-NT - October 2007

screens
REFERENCE MANUAL
The
button allows you to display the window displaying the software versions of the system
(Windows NT or XP, Internet Explorer and main software).
The
or XP system.
check box allows you to display the task manager window of the Windows NT
The Print Screen drop down box allows you to choose the destination for the screen copy.
To Printer: The screen is printed on paper.

This option is activated by default when the analyzer starts.
To File: The screen is saved to the file: C:\STAPLUS\SCREEN.

The name automatically attributed to the image corresponds to the time and date when it is
saved.
The viewing area for the contents of the C:\STAPLUS\SCREEN files allows you to view (using a
double click) or to delete (using the Delete Selection button) the images in this file.
To Floppy: The screen is saved to a diskette.

The name automatically attributed corresponds to the time and date when the image is saved. It
may be changed.
Warning: Make sure there is enough space in the floppy disk before saving.
No action: Touching the Esc key leads to no other action (whether saving or printing).
" Scroll through the Print Screen dropdown list box and click the destination for the screen copy.
" Press the Print Screen key.
5-6
0931634-NT - October 2007
REFERENCE MANUAL

screens
5.3 Display and use of the online help

The online help allows the quick display of useful information while using with the analyzer.
5.3.1 Display the online help

The online help may appear on the users request anytime and regardless of the menu currently
displayed.
" Click
The cursor
appears.
" Click the screen area for which the contextual help is required.
If there is a contextual help for that area, it appears on the screen.
5.3.2 Use the online help

The online help window is made up of one main part, on the right side of the screen, used for the
display of the requested information. The left side of the screen is made up of tabs including:
The Contents tab:
" From the Contents tab, click the icon (+) located on the left side in order to unroll the sections
of the chapter.
" Click the section that needs to be displayed.
The content of this section appears on the right side of the screen.
The Search tab:
" In the text box, type a word or sentence in relation with the request (a character or a character
string may be replaced by a *).
The chapters where the requested words or sentences appear are displayed on the left side of
the screen.
" Click a chapter to display its content on the right side of the screen.
The Favorites tab:
" In the text box of Current topic, type the name you wish to give to the topic currently displayed
on the screen.
" Click Add.
The name of the topic appears in Topics and the Display and Delete buttons become activated.
These topics thus saved in the favorites, may afterwards be either displayed (Display) or removed
(Delete).
5-7
0931634-NT - October 2007
REFERENCE MANUAL

screens
5.4 Test Panel screen

5.4.1 Description of the Test Panel
The Test Panel screen allows you to track test progress in real time for all the records whose sample
tubes are loaded or are waiting to be loaded.
It is accessed by clicking the
icon and then the Test Panel tab.
You can simultaneously open up to 10 records.

You will see several functional areas:
-
Display of complementary information for a records,

Display of the list of patient files,
The result display area,
The
button allows you to look for one or more files,
The
button allows you to suspend sampling,
The
button allows you to resume sampling,
The
button allows you to suspend transmission,
The
button allows you to resume transmission,
The
button allows you to access the archives,
5-8
0931634-NT - October 2007
REFERENCE MANUAL

screens
The
button allows you to manually identify the tubes when they are loaded,
The
reader,
button allows you to identify the tubes when they are loaded using the bar code
The
button allows you to automatically unload the rack if a tube is not read in order to
identify the tube manually,
The
button allows you to tag (or untag) records,
The vertical scroll bar,
The horizontal scroll bar.
Clicking the heading of the T column offers the possibility of:

-
Sorting by tag,
Tagging everything,
Removing all tagged items,
Transmitting the tagged files,
Download the tagged files,
Validating the tagged files,
Apply a profile to the tagged files,
Deleting the tagged files,
Display or mask the Rack, Po (position) and Sts (status).
5.4.2 Horizontal scroll bar Control panel

Using the horizontal scroll bar in the Test Panel, you can move to the right or the left in the test list.
By clicking the arrow pointing right, you move one step to the right in the test list The test displayed
on the far left disappears and a new test appears on the right.
By clicking the arrow pointing left, you move one step to the left in the test list The test displayed
By selecting the scroll box, you move to the area you want in the test list.
5.4.3 Vertical scroll bar Control panel

Using the vertical scroll bar in the Test Panel, you can move upwards or downwards in the patient
file list.
By clicking the arrow pointing downwards, you move the cursor a step downwards.
By clicking the arrow pointing upwards, you move the cursor a step upwards.
By selecting the scroll box, you move the cursor to the area you want in the list of dossiers.
5-9
0931634-NT - October 2007
REFERENCE MANUAL

screens
5.4.4 Displaying additional information

In the Test Panel, additional information (possibly name, first name, etc.) is displayed for the patient
record where the cursor is located.
The selection of the contents of additional information is defined in the Global Options screen, see
procedure in chapter 5.12 of this manual.
5.4.5 Displaying the list of patient files

The list of patient files is displayed in the form of a table in this area of the Test Panel.
A patient file, a calibrator or a control corresponds to each line in the table. The calibrators and the
controls are only displayed during their processing (from the moment they are run to the moment
the results are obtained).
Each file is identified by a checkmark (
symbol), its identification, its rack number, its position in
the rack and its specificities (for example, urgency and/or micro-volume). The icon
enables you
to visualize the identities presenting at least one result with analarm. This information is organized in
a column.
A rack and a position displayed in green indicate a pediatric tube loaded in a pediatric rack.
A rack and a position displayed in blue indicate a microcontainer tube loaded with a blue rack
intended for microcontainers.
By double clicking a patient identification, you display all the details in the patient file; see procedure
in chapter 5.10 of this manual.
By clicking the column headings, you sort the files.
A heading displayed in white means that the patient files are displayed in an order that corresponds
to the sort carried out according to this criterion (on this heading).
The T, Identity, Rack, Po (Position in the rack), Sts (specificities of the dossier) may be displayed in
the order that the operator wants to display them; see procedure in chapter 5.2.2 of this manual.
5-10
0931634-NT - October 2007
REFERENCE MANUAL
Clicking the

screens
button allows you to classify the patient files in the following order:
white
(validated files)
blue
(files to be validated)
yellow
(files in progress)
red
(erroneous files)
grey
(empty files)
Cursor position is highlighted in blue.
5.4.6 Display modes for the patient file columns

You can mask the Rack and/or Position and/or Status columns in the patient identity table.
" Click the T column heading.
-
the |T| Identity | option allows you to mask all the Rack, Po and Sts columns automatically
The Rack option allows you to mask the Rack column
The Po option allows you to mask the Position column
The Sts option allows you to mask the Status column
The columns may be displayed in the order chosen by the user, see procedure in chapter 5.2.2 of this
manual.
5.4.7 Displaying results

In this area of the Test Panel, the results of the tests for the patient files listed alongside are
displayed. To each column a test is associated.
In the column heading, you find the abbreviation for the test, the unit chosen to display the results,
the letter D, which indicates that the tests were performed twice, the symbol for the calculated
tests and if the test is a dependent test, it is displayed in italics.
The events in progress are represented by symbols.
Double clicking an empty checkbox allows you to add a test to a patient file.
Double clicking a result displays the list of possibilities: deleting the result(s), rerunning the
measurement(s), transmitting the result(s), viewing the result(s) as a grph (photometry tests).
Clicking once on the abbreviation for a test (column heading) displays the window of operations that
may be carried out on previously tagged files for this test: adding the test, blocking the test,
unblocking the test, rerunning the 1 or 2 measurements, deleting the test, transmitting the test,
validating the test or choosing the modalities for displaying the results:
-
choosing the unit for displaying the result for the test performed,
for the tests performed twice, the possibility of displaying both results obtained or of displaying
the average.
5-11
0931634-NT - October 2007

screens
REFERENCE MANUAL
You can also move the test columns to display the tests in the order that you desire; see procedure
in chapter 5.2.2 of this manual.
The re-diluted tests are presented on a yellow background (with the exception of a test in progress
).
5.4.7.1 Description of the result display in single determination
The final result is the last measurement obtained after the reruns and redulitions that might have
been required.
In single determination, the result displayed in the test panel is the final result.
-
If there is an error in the final result: this error is displayed
If there is no error in the final result: the displayed result depends on the unit chosen by the user
for control panel display, see table below.
If there is no error in the final result:

Displayed unit
Result displayed in the test panel
Raw unit
Unpeaked raw measurement
Main unit
Peaked and converted into main unit measurement if the result is

outside the editing limits
Secondary unit 1
Measurement converted into secondary unit 1

(peaked only if secondary unit 1 = INR)
Secondary unit 2

Secondary unit 3

5-12
0931634-NT - October 2007
REFERENCE MANUAL

screens
5.4.7.2 Description of the result display in duplicate determination
The final restult is the last measurement obtained after the reruns and redulitions that might
have been required.
In duplicate determination, the result displayed in the test panel depends on the final result of the first
determination (D1) and of the final result of the second determination (D2):
-
if D1 and D2 have the same error (insufficient quantity of plasma, technical error, linearity error,
M<MMin, M>MMax):
this error is displayed ("QNS", "Error", "Linearity", "V<VMin", "V>VMax")
if D1 and D2 have different errors:

"Error" is displayed
if D1 or D2 is not in error whereas the other determination is:

if D1 and D2 are not in error:

the displayed result depends on the result display options chosen by the user:
type of unit (raw unit, main unit or secondary unit 1, 2 or 3) and display of both results or of their
mean value, see table.
If the final D1 result and the final D2 result are not in errror
Display
unit

if display of both units
if display of the mean value
Raw unit
Unpeaked raw determination 1

and
unpeaked raw determination 2
Unpeaked raw mean
Main unit
D1 converted into main unit and

unpeaked
and
unpeaked
Mean calculated in main unit and

peaked
Secondary unit 1
Not applicable
Mean calculated in secondary unit 1

Secondary unit 2
Not applicable

Secondary unit 3
Not applicable

5-13
0931634-NT - October 2007

screens
REFERENCE MANUAL
5.4.8 Archives button Test Panel

The Archives menu allows you to view all the files for which the tubes have been unloaded from the
STA-R Evolution.
The test statuses are associated with an identity in this menu.
When a tube for which the tests were in waiting is reloaded, the results of the tests performed
previously are restored and the analyses for the tests in progress are run.
Note: By default, only the current days archives are displayed.
The archives file can hold up to 5000 files; the organizational principle of this file is: 1st in, 1st out.
button allows you to access the Archives menu. This offers the possibility of:
Clicking the
-
Sorting by mark,
Marking everything,
Removing all markings,
Deleting the marked files,
Transmitting the marked files,
Validating the marked files,
Printing the marked files.
5.4.9 Search Button Test Panel

Clicking the
button provides the possibility of looking for a patient file.
" Click Search by.

to the first complementary information, or click Date).
" Click Search.
" Click
to confirm.
5.4.10 Color codes on results

Color codes are used to show results presenting an anomaly. As soon as a result presents an anomaly,
an alarm
appears near the patient identity.
5-14
0931634-NT - October 2007
REFERENCE MANUAL

screens
Test rerun, for example after a technical error (missing ball etc.) or because of
detection of a time period less than the min. time (<Vmin) or greater than the
max. time (>Vmax)
Test started again because of a problem in detection of level
V>Vmax
For the chronometric tests: raw measurement greater than the max. time defined
in the test setup, or if the linear extrapolation is desactivated: raw measurement
greater than the max. time in the calibration.
For the colorimetric tests: the raw result of the test is out of the measurement
range supported by the calibration test.
V<Vmin
For the chronometric tests: raw measurement less than the min. time defined in
the test setup, or if the linear extrapolation is desactivated: raw measurement less
than the min. time in the calibration.
Error
Technical error
Lin.
Insufficient linearity for the colorimetric or immunological tests
QNS
Quantity of plasma Not Sufficient
5-15
0931634-NT - October 2007

screens
REFERENCE MANUAL
5.4.11 Patient file identification

Patient file ID numbers are 16 alphanumeric characters at most.
Color codes accompany identification when it is necessary to bring out certain elements:
validated patient file
patient file with at least one test in

progress
patient file with at least one

erroneous test
patient file with at least one test to

be validated
patient file with empty work list
download request carried out for

this patient file
patient file transmitted with no

prior downloading request (this
symbol appears only in the details
of the patient file)
manually identified or re-identified

patient file
patient file with at least one test

presenting an anomaly
Printed patient file (or in the print

queue)
In the Test Panel, a single triangle (the priority bearing one) is displayed. The orders of priority are
defined as follows, from the most important to the least important priority:
-
yellow
(files in progress)
red
(erroneous files)
blue
white
(validated files)
grey
(empty files)
In the Patient File screen from the moment when at least one test in the file has as a status: in
progress, erroneous, to be validated or validated, the corresponding triangle is displayed. In this way,
you can total the 4 codes for a file including at least 4 tests: yellow (in progress), red (erroneous),
blue (to be validated) and white (validated).
In the specific cases of calibrators or controls, identification is composed of several elements:
-
Product identification
The dilution used, only for the calibrators
The calibration number (calibrators) or the number for the control level (controls)
Example:
-
12350-20-1 STA -Unicalibrator, dilution used = 1/20, calibration n1
12354-1
STA -System Control N, first level of control
5-16
0931634-NT - October 2007
REFERENCE MANUAL

screens
5.4.12 File marker Test Panel

Clicking the
button tags the file which the cursor is on, or removes the tag if this file was already
tagged. Then, the cursor goes down a step.
You can also tag a file by clicking in the T column in front of the file to be tagged,
The
sign appears in the T column for all the tagged files.
5.4.13 Modalities for displaying results

In the Test Panel, the results are displayed in the unit selected by the operator; see procedure in
chapter 5.11.3.3 of this manual.
When the analyses have been carried out twice, you can choose to see both measurements or only
the average.
The analyses that have been carried out twice are identified by the letter D beside the unit.
For the photometric tests (colorimetric and immunological) the result(s) can be viewed as a graph;
see procedure in chapter 3.7.7.2 of this manual).
5.4.14 Rack number

6 alphanumeric characters at most.
In the specific case of calibrators and controls, this number is replaced by the position of the vial in
the products drawer, that is R0-xx. (R0: left area of the drawer and xx number for the position).
If there is a wait for the sample tube for a patient file to be loaded, the
the place of the rack number.
symbol appears in
A rack number displayed in blue indicates that it is a blue rack intended for microcontainers. The
microcontainer status is then automatically affected to the patient in the Patient Acquisition screen.
5-17
0931634-NT - October 2007

screens
REFERENCE MANUAL
5.4.15 Symbols used for the patient files in the Test Panel
The following symbols show the specificities of each patient file: They are displayed in the Sts (status)
column.
Stat patient file
Sample tube loaded into a microcontainer or a pediatric tube
Stat patient file with sample tube

loaded into a micro-container or a
pediatric tube
Patient file corresponding in fact to

a calibrator

a quality control
Printed patient file (or one in the

printing queue)
5.4.16 Symbols used for the tests in the Test Panel

cuvette
Distribution of the intermediary

reagent(s)
Distribution of the start reagent
progress
Measurement of colorimetry in
progress (405 nm)
progress (540 nm)

product
Test requested for a patient file

with sample tube waiting to be
loaded
5-18
0931634-NT - October 2007
REFERENCE MANUAL

screens
5.5 Sample loading screen

5.5.1 Sample (Un)Loading screen
By means of this screen, you can view the identities of the racks present inside the analyzer. For each
rack, you can find out how many sample tubes are loaded and what their identities are. In this way,
you can tag the racks with a view to their unloading.
This screen can be accessed by clicking the
icon and then the (Un)Loading tab.
The list of the racks known to the analyzer appears on one side of the screen, and the state of the
tray appears on the other side. The list of the identities for the rack that you have pointed to appears
in the middle.
The following functions are also available from this screen:
-
Automatic profile adding
Downloading
Removing the tray
Unloading tagged racks
Reload the rack(s) present on the tray
Printing the list of racks on board

on the screen above)
(appears in the status bar at the bottom right, invisible
When you click Identities in Rack the following functions appear:
5-19
0931634-NT - October 2007
REFERENCE MANUAL

screens
-
Initialize the rack conveyor
Enter the repeatability
number
5.5.2 State of the tray

Sample (Un)Loading screen.
Color coding allows you to identify the state of the tray.

The racks in the tray are represented graphically. Cursor position is highlighted in blue.
Color code
Meaning
Green frame
The tray may be removed.
Red frame
The tray is blocked; it cannot be removed.
Frame in red with an exclamation mark
Determination of the number of racks to be

loaded into the analyzer in progress.
Frame in red with a moveable red arrow

pointing downwards
Loading racks from the tray to the analyzer in

progress.

pointing upwards
Unloading racks from the analyzer to the tray in

progress.
Grey frame
Tray missing
5-20
0931634-NT - October 2007
REFERENCE MANUAL

screens
5.5.3 List of known racks

The list of racks known to the analyzer is displayed in the form of a table in the (Un)Loading area
of the screen
Each line in the table corresponds to a rack that is identified by the tag it may have (
number and its status.
Status and number
symbol), its
Meaning
and number of the rack displayed in white

and number of the rack displayed in yellow
and number of the rack displayed in grey
Rack that has been unloaded and that is in

the tray
Rack with at least one tube with tests in
progress
When you click the column headings, you carry out sorts on the racks; see procedure in chapter 5.4.5
of this manual.
A heading displayed in white means that the racks are displayed in an order that corresponds to the
sort carried out according to this criterion (on this heading).
The columns T (rack tagged), Rack and Status may be displayed in the order that the operator
desires; see procedure in chapter 5.2.2 of this manual.
Cursor position is highlighted in blue. For the racks that are in the tray, the rack that corresponds to
the cursor position is also highlighted in blue in the graph that represents the tray.
5-21
0931634-NT - October 2007
REFERENCE MANUAL

screens
5.6 Patient Acquisition

5.6.1 Patient Acquisition screen
This menu allows you to create patient files without loading the corresponding tubes; the tubes will
be loaded later and the test list will be automatically added.
The creation of a new patient file is done by clicking the
icon.
You can also create or change the test list for the existing patient file (add a test or a test profile)
whether the tubes are present or not. The test profiles are defined in this screen; see procedure in
Changing an existing patient file is done by clicking the
This screen is accessed by clicking the
icon.
Part of this screen is reserved for the complete identification of the patient file and the other for test
selection.
5.6.2 Complete identification of a patient file

In this area of the Patient Acquisition screen, you find the information related to the complete
identification of a patient file with:
-
Identification,
The complementary information (possibly name, first name, etc.). The coherence of the contents
of the complementary information is defined in the Global Options screen, see procedure in
chapter 5.12 of this manual.
5-22
0931634-NT - October 2007
REFERENCE MANUAL

screens
The rack number,
The position in the rack,
The notion of urgency (
Loading to micro-container or pediatric tube (
displayed),
displayed),
For the calibrators and the calibration controls, the
symbol is displayed and for the quality
controls
. The calibrators and the controls are only displayed during their processing (from
running them to obtaining the result).
The
icon provides access to the change in the patient file either in complete identification or
in test selection.
In the specific case of a patient file with unloaded tube, the
the rack number.
symbol is displayed in the place of
5.6.3 Test selection

This part of the Patient Acquisition screen allows you to select tests either individually or by using
profiles.
The individual tests to be selected are displayed in a list.
The previously selected tests are identified by a red triangle
selected are identified by a green triangle
; the tests in the course of being
The Profile nx or Automatic buttons allow you to apply the corresponding test profile to the
patient file.
The
button provides access to the definition of various profiles and to changing them.
5-23
0931634-NT - October 2007

screens
REFERENCE MANUAL
5.7 Product loading screens

5.7.1 Loading screen
5.7.1.1 Open screen
The Open screen is similar to the List of products screen below. The 3 main differences are:
-
The displaying of a window at the bottom of the screen for identification of products to be loaded,
The disappearance of information relating to the cleaning solution (STA-Cleaner Solution) and
to the cuvettes,
The
icon allows you to display the list of missing products (it only displays on the screen
when a product is missing).
Note: The LEDs next to the vial flash for products that are no longer valid in terms of stability and/
or expiration date and/or volume. As far as volume is concerned, the end of the vial means that the
volume left is less than or equal to the minimum volume.
5-24
0931634-NT - October 2007
REFERENCE MANUAL

screens
5.7.2 List of products screen
5.7.2.1 List of products screen
The List of products screen brings together all the products loaded in the analyzer.
It can be accessed by clicking the
icon and then the List of products tab.
You have the contents of the products drawer: reagents, diluents, decontaminating solution
(STA-Desorb U), calibrators and controls and on the other hand, the quantities available for the
cleaning solution (STA-Cleaner Solution) and the cuvettes.
For each product, you have its identification number, its name, its type, its position in the drawer,
its lot number, its theoretical stability, its end of use and the volume that is available.
When you double click the product, you display the information that has been identified from the bar
code.
This information is displayed in the form of a table with one line per product and a column for each
piece of information. The columns can be displayed in the order desired by the operator; see
When a product is not useable (the barcode sheet was not read or no calibration has been required
for the lot) or is no longer useable (insufficient volume, stability exceeded, problem in level
detection), the whole line of information is displayed in gray.
When you click the column headings, you carry out sorts on the products; see procedure in chapter
5.4.5 of this manual.
To see a graphic representation of the drawer, click the Drawer tab. The cursor position is kept then.
5-25
0931634-NT - October 2007

screens
REFERENCE MANUAL
5.7.2.2 List of Missing Products Screen
The List of missing products screen (see chapter 5.7.1.1 of this manual) brings together all the
products required to perform the work load and which are not yet in the products drawer.
For each missing product, you have:
-
the area of the drawer in which it should be loaded,
the product identity,
the product name,
the number of loaded vials / the number of vials required.
5.7.2.3 End of use for the loaded products

List of products screen: expiration time and date for each product loaded in the products drawer.
Drawer screen: expiration time and date for the selected product.
To calculate the expiration time and date, the software adds the stability defined in the Test Setup
screens to the time and date when the product was loaded.
A yellow triangle
is displayed one hour before the products end of use.
A red triangle
is displayed when the end of use is exceeded. In this case, the whole line of
information is displayed in gray.
The
icon flashes in the system panel and an alarm sounds to show that products are missing.
5.7.2.4 Name of loaded products

List of products screen: name of each product loaded in the products drawer.
Drawer screen: name of the selected product.
A red triangle
means that the product is not useable (the barcode sheet was not read or no
calibration was required for the lot) or is no longer useable (insufficient volume, stability or problem
in level detection). In this case, the whole line of information is displayed in gray.
5-26
0931634-NT - October 2007
REFERENCE MANUAL

screens
A yellow triangle
means that the product will soon no longer be useable (volume close to the
lower limit and/or stability soon exceeded).
A green triangle
is useable without restriction.
5.7.2.5 Lot number of the loaded products

List of products screen: lot number of each product loaded in the products drawer.
Drawer screen: lot number of the selected product.
A red triangle
means:
that the bar code sheet corresponding to this lot was never read (the
the lot number),
or that no calibration was ever required for this lot.
icon is displayed beside
In this case, the whole line of information is displayed in gray.

The lot number 999999 corresponds to the products for which the lot number is not assigned.
5.7.2.6 Identification number of the loaded products

List of products screen: identification number of each product loaded in the products drawer.
Drawer screen: identification number of the selected product.
The
stir symbol appears beside the identification number for the products that need to be
stirred by a magnetic stir bar.
Note: When a product is not useable (the barcode sheet was not read or no calibration has been
required for the lot) or is no longer useable (insufficient volume, stability exceeded, problem in level
detection), the identification number as well as the whole line of information related to the product
is displayed in gray.
5.7.2.7 Position of loaded products

List of products screen: position of each product loaded in the products drawer.
Drawer screen: position of the selected product.
Each position is identified by an RX-xx coding.
RX corresponds to the areas in the drawer and xx to the position number in the area.
RX
Area
Type of products
R0
Left
Calibrators, controls, diluents, decontaminating solution
5-27
0931634-NT - October 2007
REFERENCE MANUAL

screens
R1
Central

decontaminating solution
R2
Right
Reagents to be distributed after the first incubation

(mainly start reagents), decontaminating solution
The
letter symbol appears for the positions requiring stirring by magnetic stirrer.
The
symbol (List of products screen) or
(Drawer screen) appears beside the position of
the products loaded without positive identification.
detection), the position as well as the whole line of information related to the product is displayed in
gray.
5.7.2.8 Stability of loaded products

List of products screen: theoretical stability of each product loaded in the products drawer.
Drawer screen: theoretical stability of each selected product.
This stability is defined in the Test setup screens.
gray.
5.7.2.9 Type of loaded products

List of products screen: type of each product loaded in the products drawer.
Drawer screen: type of the selected product.
Type of product
Abbreviation used in the

List of products screen
Title used in the Drawer

screen
Diluent
Dilu.
Diluent
Decontaminating solution
(STA-Desorb U)
Clean.
Cleaner
Reagent
Reag.
Reagent
Control
Ctrl.
Control
Calibrator
Cal.
Calibrator
Unknown product
Non identified
Non identified
5-28
0931634-NT - October 2007
REFERENCE MANUAL

screens
detection), the type as well as the whole line of information related to the product is displayed in gray.
5.7.2.10 Volume on board for loaded products

List of products screen: volume actually available for each product loaded in the products drawer.
Drawer screen: volume actually available for the selected product.
The Volume On Board corresponds to the volume of the vial without taking into account the
minimum volume.
The Minimum Volume is defined in the Test setup screens. When the product has been decanted
into an STA -Microcups, the minimum volume equal to 200 l is automatically updated; the
letter symbol is then displayed.
A yellow triangle
is displayed when the volume on board is equal to or less than 20%.
A red triangle
is displayed when the minimum volume is reached (volume on board = 0) or when
a problem in level detection has been detected. In this case, the whole line of information is displayed
in gray.
5.7.3 Forecast screen
5.7.3.1 Forecast screen
Provisional administration is performed in real time. The contents of the screen are re-updated every
time the racks are loaded as well as every time the products drawer is closed.
5-29
0931634-NT - October 2007
REFERENCE MANUAL

screens
The Forecast screen is automatically displayed for 15 seconds if a product to carry out the work load
is going to be missing. The analyses are blocked then in order to allow the operator to intervene.
The Forecast screen brings together all the products (diluents, controls, calibrators, reagents,
decontaminating solution, cleaner) as well as the number of cuvettes required to perform either all
the tests (default display).
The state of the analyses for all the tests (default display) is also shown.
icon and then the Forecast tab.
This information related to each product is displayed in the form of a table with one line per product
and a column for each piece of information.
Consequently you have:
-
The product loading area,
The identification number of the product,
The product name,
The margin.
When a product is missing or present but not useable (calibration not performed), the margin is
displayed in red.
You can print the list of missing products (the number of vials required to perform the analyses is
indicated) using the
icon.
5.7.3.2 State of the analyses Forecast screen

Number of analyses according to their state for the selected test(s):
Total
Number of analyses in waiting
Number of analyses for which the

sample tube is waiting to be
loaded
Number of analyses blocked by

the user
Number of analyses blocked

because of missing products


measurements are in progress
Total number of analyses

(= sum of 6 others)
The analyses concern the sample tubes, the controls and the calibrators.
The estimated end of work is re-updated in real time at every change in work load.
5-30
0931634-NT - October 2007
REFERENCE MANUAL

screens
5.7.3.3 Loading area Forecast screen

For the products required for running the selected and already loaded test(s), R. area of the products
drawer in which the product has been loaded.
For the missing products, area in which the product is expected.
R.
Area
Type of products
R0
Left
R1
Central

R2
Right
Reagents to be distributed after the first incubation (mainly

releasing reagents), decontaminating solution
5.7.3.4 Identification of the products Forecast screen

Identification number (ID) for each loaded product as well as for each product waiting for the running
of the selected test(s).
5.7.3.5 Name of the products Forecast screen

Name of each product required for running of the selected test(s).
5.7.3.6 Product margin Forecast screen

The margin for each product required for running of the selected test(s) is the quantity of product
that will be left after running of the requested test(s) (this quantity takes into account the minimum
volume of the vial).
Margin administration is performed in real time. The margin is updated every time the racks are
loaded as well as every time the products drawer is closed.
A green triangle
means that nothing is to be reported for this product: the margin once the work
load carried out is positive.
A red triangle
means that the product is missing or not useable (stability exceeded, insufficient
volume or absence of calibration for this batch).
The samples are blocked and the
icon flashes in the system panel.
5-31
0931634-NT - October 2007
REFERENCE MANUAL

screens
If controls or calibrators are missing, the
5.7.4 Drawer screen
5.7.4.1 Drawer screen
In the Drawer screen, you can see on the one side a graphic representation of the products drawer
and on the other side, all the characteristics of the vial that has been selected.
5.7.4.2 Characteristics of the selected vial

For the selected vial (represented on the screen by a
are displayed:
symbol), all the characteristics of this vial
Its position in the products drawer; the area is indicated in a light shading,
Its identification number,
Its name,
Its type,
Its lot number,
Its loading time and date,
Its theoretical stability,
Its utilization time and date,
5-32
0931634-NT - October 2007
REFERENCE MANUAL

screens
Its on board volume,
Its volume minimum (defined in the Test Setup screens).
5.7.4.3 Graphic representation of the products drawer

The products drawer is represented in the form of a graph with colors that allow you to identify the
status of each product.
Unoccupied position.
Occupied position, vial with no problems.
Occupied position, vial near the end of stability or volume.
Occupied position, vial unused (insufficient volume or stability exceeded).
Stirring position.
Position number = 15
Position currently selected by the cursor. The information displayed on the left of
the screen corresponds to this position.
The blue circle
identification.
indicates that the product has been loaded without positive
The
letter symbol appears beside the position for the products that were
loaded without positive identification.
e.g.: R0-24
Cursor position.
5.7.5 Barcode label reading window

The Barcode label reading window appears:
-
at loading time for a reagent with a new lot number,
after you double click a line concerning a reagent for which the
the lot number (List of products screen, drawer closed).
symbol is displayed beside
5-33
0931634-NT - October 2007

screens
Note: The red symbol
5.7.2.5 of this manual.
REFERENCE MANUAL
may have 2 meanings; see Lot number of loaded products in chapter
Before the bar code sheet is read, only the partial lot number and the product identification are
displayed. After the sheet is read: the product box reference number, the expiration date and the
complete lot number appear.
When you click Please pass label in front of barcode reader, you display a window in which you
may scan the bar code sheet under the bar code reader if the bar code has not been read properly;
5.8 Calibration screens

5.8.1 General information about calibrations
The calibrations can be run from the Calibration menu (accessed by the
running procedure in chapter 3.8.1 of this manual).
icon, see this
You can use two calibrations for the same test.

The Calibration screen is divided into 3 parts:
-
an area to display the calibration curve,
an area to display either the list of products that have been used to perform the calibration, or a
table of calibration points,
a section to display the test list.
5.8.2 Calibration curve

Calibration screen
The selected calibration curve is displayed with:
-
The theoretical concentrations along the X-axis,
The measurements along the Y-axis,
The time and date of the validation of the calibration,
The equation for the calibration curve,
The regression coefficient,
The value of the ISI (International Sensitivity Index) coefficient. This only appears if the INR
(International Normalized Ratio) unit has been chosen.
For the Raw and Ratio calibration modes, there is no calibration curve. In the Ratio calibration
mode, the reference time is displayed in this area of the screen.
Each calibrator is represented by a blue point. The point, which is marked by two dotted lines
representing its coordinates on the X-axis and on the Y-axis, corresponds to the calibrator on which
the cursor is located in the table of points.
5-34
0931634-NT - October 2007
REFERENCE MANUAL

screens
5.8.3 Test list Calibration screen
5.8.3.1 Test list Calibration screen

The first tests from the available tests are displayed in the form of a list.
To look for a test that does not appear among the displayed test, you need to use the vertical scroll
bar.
For each test, you can have two colored triangles. In this way, you can identify the status of the
calibrations for each test at a glance.
The choice of one of the two calibrations possible for each test is made by clicking
the first calibration and
to display
to view the second one.
Double clicking the test abbreviation gives you access to the functions possible for the calibrations
connected to this test:
-
Rerun the calibration,
Calibrate,
Canceling a calibration in progress,
Deleting a calibration,
Modifying the100% Pt,
Changing the reference time and the ISI value,
Validate on the basis of the regression coefficient (validation R. coef.).
5.8.3.2 Meaning of the colored triangles

Calibration screen - Test list
Each test is associated with two colored triangles that give the state of the two calibrations in this test:
A single
triangle
There is only one calibration associated with this test.

First validated calibration.
Second validated calibration.
First calibration in progress.
Second calibration in progress.
5-35
0931634-NT - October 2007

screens
REFERENCE MANUAL
First calibration not performed or erroneous

Second calibration erroneous
First calibration to be validated.
Second calibration to be validated.
5.8.4 Products tab Calibration screen
5.8.4.1 Products tab

Calibration screen
List of products that have been used to perform calibration with reagents.
To view the information related to each reagent, you only need to click the corresponding button
(Ra, Rb, Rc or Rd).
5.8.4.2 Calibrators used in the calibration

Calibration screen Calibration Pts. tab
You can extend the points table by 3 extra columns that contain information related to each
calibrator:
" Double click inside the table
" Select Calibrators List
ID
Product identification number of the calibrator used in the calibration.
Name
Complete name of the calibrator used in the calibration.
Lot
Lot number corresponding to the calibrator used in the calibration.
Information identical to that displayed on the line above.
The name of the test and the calibration mode are displayed under the calibration points table.
5-36
0931634-NT - October 2007
REFERENCE MANUAL

screens

Calibration screen Products tab Reagents area
ID
Product identification number of the selected reagent (Ra, Rb, Rc or Rd).
Name
Complete name of the selected reagent (Ra, Rb, Rc or Rd).
Lot
Lot number corresponding to the reagent used in the calibration.

Note: For the client products, entering the batch number is indispensable (1
digit minimum).
Ra, Rb, Rc correspond to the intermediary reagents; Rd to the start reagent.
5.8.5 Table of points tab Calibration screen
5.8.5.1 Table of Points tab

Calibration screen
Display of some elements of calibration in the form of a table.
The available data is:
-
Calibrators,
Measurements,
Interpolated results.
By double clicking one of the lines in the table (one of the calibrators), you can rerun, change or
delete the calibration point.
By double clicking in the table once and then selecting Calibrators List, the information related to
the calibrators (ID, Name and lot number) is displayed.
When you place the cursor on a line in the table, you automatically see the marker for the
corresponding calibrator on the curve. This marking is seen through two dotted lines that extend
from the point and intersect the X and Y-axes.
The calibration mode (Linear, 2nd order polynomial, 3rd order polynomial, Hyperbola, Raw,
Ratio) is provided at the bottom of the points table. The pre-calibrations are identified by the
symbol, which is displayed as wells as the mode.
For the calibration modes: Raw and Ratio, only the indication of calibration mode is provided.
5-37
0931634-NT - October 2007

screens
REFERENCE MANUAL
5.8.5.2 Theoretical concentration of the calibrators

Calibration screen Table of Points tab
Calibrators = theoretical concentration of the calibrators in the main result unit. For the precalibrations, viewing points as defined in the Test setup screens.
When a calibrator required for running of a calibration is not in the Products drawer at running time,
the
symbol is displayed for the theoretical calibration.
The
5.8.5.3 Raw measurements for the calibrators

Calibration screen Table of Points tab Meas. Column
When the calibration has been run, each event is represented in the Meas. Column by a symbol:
Measurement waiting to be
processed

cuvette

reagent(s)
progress
progress (405 nm)
progress (540 nm)

product
Concentration thresholds not

entered for a calibrator
Calibrator missing or present in

the drawer but with a bar code
that has not been read
As the results and the raw measurements in the calibration are obtained, they are displayed in the
Meas. column:
-
for coagulation analyses, coagulation time measured in seconds,
for colorimetric and immunological analyses in .D.O or in D.O./min.
Error messages are used to show results presenting an anomaly:
Error
Technical error.
5-38
0931634-NT - October 2007
REFERENCE MANUAL

screens
M>MMax
For the chronometric tests, raw measurement greater than the max. time defined
in the test setup.
M<MMin
For the chronometric tests, raw measurement less than the min.. time defined in
the test setup.
Lin.
Insufficient linearity for the colorimetric or immunological tests.
Problem in level detection.
For the pre-calibrations, raw values recalculated from the equation for the curve (read by bar code)
and from the viewing points defined in the Test setup screens.
5.8.5.4 Interpolated results for the calibrators

Calibration screen Table of Points tab Interpol. Column
Values of calibrators calculated after interpolation from the equation found for the calibration curve
(in the main result producing unit).
For the pre-calibrations, no value is indicated (unused column).
5.9 Quality control screens

5.9.1 General principles for quality controls
The quality controls are loaded in area R0 in the products drawer.
For each new lot number, the threshold values for the quality controls of the STA line are read using
bar code sheets found in each box of controls. For the other controls, the threshold values must be
entered manually.
For Diagnostica Stago controls, the threshold values are correctly attributed in the appropriate test
if the main unit selected for them is the same as the one defined on the stickers on each box of
controls (except for Fibrinogen; for the main unit g/l, the values will be correctly attributed even if
they are given in mg/dl on the sticker).
The quality controls for a given test are automatically run by the STA-R Evolution as soon as it is to
carry out an analysis corresponding to this test and when one of its criteria for running QC that was
defined in the Test setup screens has been met. This criterion may be the time, the number of tests
or a change of vial (only if the vial is on board).
The quality controls can also be run manually; see procedure in chapter 3.5.1 of this manual.
The quality controls are run either once or twice according to the determination type selected for
the sample. When they are run twice, each result is considered to be an individual result.
5-39
0931634-NT - October 2007
REFERENCE MANUAL

screens
If the result of the quality control is outside of the acceptance range, all the patient results for the test
in question will be accompanied by an alert message: "Quality control: out of range or not done".
If the operator decides to accept the results of a quality control that has been declared to be nonstandard, all the patient results for the test in question will be accompanied by an alert message:
"Quality control: forced validation".
The exploitation of quality controls is based on the Levy-Jennings statistical model.
i=n
xi
Mean
=1 m = i------------n
with
xi = result in the main unit

n = number of results
i=n
( x m )2
i
Standard deviation
Variation coefficient
i--------------------------=1
n1
100
cv = -----------m
5.9.2 Quality Control screen
The choice between the various levels of control is made by clicking the Control Level # tab.
When you access this screen, the information displayed corresponds to the last control carried out.
The Quality Control screen is divided into several parts:
area for display of information about the level of the selected control
numeric display area for information on the selected point (using the cursor)
graphic display area for the DAILY CONTROLS
5-40
0931634-NT - October 2007
REFERENCE MANUAL

screens
numeric display area for the DAILY MEAN
graphic display area for the DAILY MEANS
numeric display area for the MONTHLY MEAN
graphic display area for the MONTHLY MEANS
numeric display area for the ANNUAL MEAN
area to display the test list
10 display area for the buttons related to the possible functions

11 display area for the test name
12 display area for the name of the graphic. When you click it, this area shows the scale
5.9.3 List of possible functions Quality Control screen
Allows you to run a quality control manually

(see procedure in chapter 3.5.1 of this manual)
Allows you to change the result acceptance range
Allows you to delete a quality control result
Allows you to validate a quality control result
Allows you to purge all quality control results for the level selected
Allows you to display the last quality control result
Allows you to transmit a quality control result
Allows you to display the controls of the day
5-41
0931634-NT - October 2007

screens
REFERENCE MANUAL
5.9.4 Test list Quality Control screen

bar.
For each test, you have a colored triangle that allows you to identify the status of the last control
associated with this test at a glance:
Validity control
Control in progress
Control to be validated
Erroneous control or unperformed
control
5.9.5 Information on the level of the quality control

Quality Control screen
In the areas 1 and 11 of the Quality Control screen (refer to chapter 5.9.5), the identification
number and the clear name of the quality control are repeated.
When running a quality control which has been requested and as long as it is not in progress, this
entire area is displayed in yellow. For each cuvette (2 for determinations performed twice), each
event is then represented by a symbol:
Control missing in Products drawer

product
processed
Distribution of the control in the

cuvette

reagent(s)
progress
progress (405 nm)
progress (540 nm)
During running, the lot number of the control used is shown.
5-42
0931634-NT - October 2007
REFERENCE MANUAL

screens
5.9.6 Definition of the terms used Quality Control screen
Term
Meaning
Daily control
In the graphic area, each point corresponds to a quality control result.
Daily mean
In the graphic area, each point corresponds to the average of the

quality controls for a given day.
Monthly mean

quality controls for a given month.
Annual mean
In the digital results area, the values shown correspond to the average
(Moy.), the standard deviation () and the variation coefficient (CV)
calculated for the last 12 months.
5.9.7 Graphical displays
5.9.7.1 Graphical display of daily controls Quality Control screen
In this graphic area of the Quality Control screen, you have:

-
All the results of the daily controls for the day in progress (displayed by default when you access
this screen).
The result of each daily control displayed with a color code:
Daily control validated with a comment.

Daily control within the acceptance range.
5-43
0931634-NT - October 2007
REFERENCE MANUAL

screens
Daily control to be validated outside the acceptance range.

Daily control validated outside the acceptance range.
Daily control deleted with a comment.
Deleted daily control.
Erroneous daily control.
-
The graphical representation:

- of the default minimum and maximum thresholds (dotted white horizontal lines),
- of the average of the default acceptance range (solid horizontal white line) and corresponding
to the batch used for the control,
- of the change of batch (vertical blue line). The various white lines (see above) are represented
in terms of the numbers of the batches to which they are linked.
Note: Each result is represented by a point. When you have chosen duplicate determination for the
tests, you then have two points.
When you move over the various points in the DAILY MEANS, the result corresponding to the
selected point (
) in the graphic area is displayed numerically on the first line of the area for
information on the selected point.

When you move over the various points in the DAILY MEANS, all the results of the controls that
correspond to the selected day (
) are automatically redisplayed in the DAILY CONTROLS.
5.9.7.2 Graphical display of daily totals Quality Control screen

-
The results of the daily controls for the month in progress (displayed by default when you access
this screen). For a month, you can have 31 values at most. The number for each day is displayed
at the bottom of the graph. The average of the daily controls is called the daily total.
Each dot on this graph is identified by the status color of the last control of the day that it
5-44
0931634-NT - October 2007
REFERENCE MANUAL

screens
represents (see chapter 5.9.7.1 of this manual).

When at least one of the control of the day is commented, the dot of the corresponding daily total
is identified by a red mark.
-

- of the average of the daily totals solid yellow horizontal line),
- of the average area 2 of the daily totals (dotted yellow horizontal lines),
- of the average in the acceptance range (solid white horizontal line),
- of the minimum and maximum thresholds (dotted white horizontal lines) corresponding to the
batch used for the control,
- of the change of batch (vertical blue line). The various white and yellow lines (see above) are
represented in terms of the numbers of the batches to which they are linked. For the monthly
total that corresponds to the change of batch, you keep the daily totals linked to the last batch
used in the month,
- of the date of the first and the last quality control performed (vertical black lines).
Note: When you move over the various dots in the DAILY MEANS, the numeric data (average,
standard deviation and variation coefficient) of the selected dot (
) in the graphic area are
displayed in a light color in the DAILY MEANS numeric area.

When you move over the various dots in the MONTHLY MEANS, all the daily totals that
correspond to the selected month (
) are automatically redisplayed in the DAILY MEANS.
5.9.7.3 Graphical display of monthly totals Quality Control screen

-
The monthly totals of the results of the quality controls for the last twelve months. This display
is of the sliding type. The number for each month is displayed at the bottom of the graph.
Each dot on this graph is identified by the status color of the last control of the month that it
When at least one of the control of the month is commented, the dot of the corresponding
monthly total is identified by a red mark.
The graphic representation for each calendar month:

- of the average of the monthly totals solid yellow horizontal line),
- of the average area 2 of the monthly totals (dotted yellow horizontal lines),
- of the average in the acceptance range of the last batch used in the month (solid white horizontal
line),
5-45
0931634-NT - October 2007
REFERENCE MANUAL

screens
represented in terms of the numbers of the batches to which they are linked. For the daily total
that corresponds to the change of batch, you keep the daily totals linked to the last batch used in
the day,
Note: The numerical data: average (Moy.), standard deviation () and variation coefficient (CV)
corresponding to each month selected (
area.
) are displayed in the MONTHLY MEANS numerical
5.9.7.4 Display of the graphic and its scale Quality Control screen
" Click the area of the name of the graph to display its scale.
The scale provides the following information:

-
The average of the acceptance range of the selected dot (value shown facing the solid white line).
The average area 2 s of the totals (value shown facing the dotted yellow horizontal lines).
The minimum and maximum thresholds (value shown facing the dotted white lines).
The value of the selected dot.
The values displayed on the scale of the graph are expressed in main units.
5-46
0931634-NT - October 2007
REFERENCE MANUAL

screens
5.9.8 Numeric information
5.9.8.1 Numeric information - Quality Control screen
In this area of the Quality Control screen, are displayed:

-
the information about the selected dot (selected using the cursor) for the day's controls,
the information about the selected dot for the daily totals,
the information about the selected dot for the monthly totals,
the information about the annual total.
When you access the Quality Control screen, the information displayed corresponds to the last
control carried out.
5.9.8.2 Information about the selected dot - Quality Control screen
Description of this graphic area of the Quality Control screen:

-
Display on the first line of the data related to the last control carried out (displayed be default
when you access the screen) with:
xx/xx/xxxx
Date that the quality control was performed (e.g. 07.02.2000).
5-47
0931634-NT - October 2007
REFERENCE MANUAL

screens
xx:xx
Date that the quality control was performed (e.g. 04:49:00 PM).
xxx U
Result of the quality control expressed in the main unit (e.g. 1.15 g/l)
These three pieces of information are displayed in:

- green when the result has been validated,
- blue when the result is to be validated,
- red when the result is validated outside the acceptance range or erroneously.
-
Display of the
icon when a comment is associated to the selected daily control. Click this
icon to read the comment.

-
Display of the lot number corresponding to the daily control selected (
Display of a symbol that identifies the conditions under which the selected control was run:
),
Control automatically run as a function of time.

Automatically run as a function of the number of tests.
Control run manually by the operator.
Control automatically run when products are loaded and when vials are changed.
Display of the minimum (Min) and maximum (Max) thresholds of the acceptance range that
correspond to the daily control selected (
) are repeated on the last line.
Note: When you move over the various dots in the graphic area of the DAILY CONTROLS, the
various graphic areas and the numeric values of the selected dot (
) are updated.
The
key allows you to move one step to the right (next dot) in the graphic area and the
allows you to move one step to the left (previous dot).
key
When a result is erroneous, no numeric value is available; an error code: Error, M>Mmax,
M<Mmin, Lin. and
is then displayed according to the type of error. For the meaning of the
error codes, see Color codes for results in chapter 5.4.9 of this manual.
Note: Mmin and Mmax values are raw measurements.
5-48
0931634-NT - October 2007
REFERENCE MANUAL

screens
5.9.8.3 Information on daily totals - Quality Control screen
DAILY MEAN Numeric area

-
Display of the mean (Mean), of the standard deviation () and the variation coefficient (CV) that
correspond to the daily totals for the month in progress (displayed by default when you access
the screen).
Note: When you move over the various dot in the graphic area of the DAILY MEANS, the various
graphic areas and the numeric values (average, standard deviation and variation coefficient) of the
selected dot (
The
) are updated.
key allows you to move one step to the right (next daily total) in the graphic area and the
key allows you to move one step to the left (previous daily total).
When you move over the various dot in the graphic area of the MONTHLY MEANS, the various
graphic areas and the numeric values (average, standard deviation and variation coefficient) that
) are automatically updated in the MEANS.
The
key allows you to move one step to the right (next monthly total) in the graphic area and
the
key allows you to move one step to the left (previous monthly total).
5.9.8.4 Information on monthly totals - Quality Control screen
MONTHLY MEAN Numeric area

-
Display of the mean (Moy.), of the standard deviation () and the variation coefficient (CV) that
the screen).
Note: When you move over the various dots in the MONTHLY MEANS, the various graphic areas
and the numeric values (average, standard deviation and variation coefficient) that correspond to the
selected month (
) are automatically updated.
5-49
0931634-NT - October 2007

screens
REFERENCE MANUAL
The
the
5.9.8.5 Information on annual total - Quality Control screen
ANNUAL MEAN Numeric area

-
correspond to the monthly totals for the last twelve months.
5.10 Patient File screen

5.10.1 Patient File screen
The Patient File screen appears when you double click a patient identification from the Test Panel.
It brings together all the information relating to a patient file with:
-
Patient ID number
Its possible markings (
If necessary, symbols indicating various specificities
The patients demographics information (possibly name, first name, etc.). This corresponds to the
contents of the complementary information found in the Global Options screen, see procedure
in chapter 5.12 of this manual
The positioning of the sample tube: rack number and position of the tube in the rack
The number of tests for the patient
The test list with the results and the associated statuses
If necessary, a complementary note
The dates
The indications of used limits
Extra data on measurements
The
button to give non-stat patients a stat status or the
patients a non-stat status
The
symbol displayed)
button (Normal) to give stat
button (transmission of a patient file)
5-50
0931634-NT - October 2007
REFERENCE MANUAL

screens
5.10.2 Writing a note

You can attach a complementary note to a patient identification.
This note is written when the patient files are printed. It is also transmitted directly to the server.
The note can be no longer than 50 characters.
You can write a note, or choose from a list of 10 standard notes.
-
Clicking once on the
Double clicking the
The
file.
button allows you to write a note.

button allows you to display the list of standard notes.
button allows you to select, to change and to assign a standard note to the patient
5.10.3 Dates - Patient File screen

Two dates are displayed in this area of the Patient File screen.
The Tube loaded date corresponds to the effective time and date the sample tube was loaded in the
pipetting area.
The Test ended date corresponds to the end of the measurement (or the measurements) for the
test on which the cursor is located.
5.10.4 Limits - Patient File screen

The limits displayed in this area of the Patient File screen correspond to the test on which the cursor
is located.
The validation limits and the printing limits are defined in the Test setup screens.
5.10.5 Raw measurement - Patient File screen

is located.
In the first column, you have the result(s) expressed in raw measurement, that is:
-
Sec. = Seconds for the coagulation tests,
.D.O. = delta of optical Density for the photometric tests in 2 point kinetics,
O.D./mn (optical density per minute) for the photometric tests in O.D./mn.
In the second column, you find the result(s) expressed in primary units.
Note: Results can be selected for single or duplicate mode. You will receive one or two results
accordingly.
5-51
0931634-NT - October 2007

screens
REFERENCE MANUAL
If a measurement is rerun, the old value is backed up and is displayed on the last line in this area.
5.10.6 Status of the results

Patient File screen
For each test, test status or result status.
The events in progress are represented by symbols. To these symbols are attached clear texts:
Running, Awaiting, Blocked and No Tube.
When a result is available, the possible statuses are: To be validated, Validated or Test invalid.
When one or more alerts have been associated with the result, the
Status column.
symbol is displayed in the
The re-diluted tests are displayed against a yellow background.
5.10.7 Test/Result/Status Patient File screen

In this area of the Patient File screen, the results of the patient file are displayed in the form of a
table.
The first column contains the test abbreviations, the second column has the average of the result
expressed in the primary unit. In the following columns (3, 4 and 5), you find the averages of the
results expressed in secondary units should this type of unit has been defined. Finally, in the last
column, the result status appears.
On each line of the table, you have the test abbreviation, the results (main and secondary units) and
the status associated with this test.
When you enter the screen, the cursor is located on the first test (first line). Extra information
relating to this test is displayed in the Dates, Range and Raw data areas. As you move the cursor
over the tests, these areas are updated.
The
symbol displayed beside the test abbreviation means that this test has been transmitted to
the server. It only appears in the details of the patient file it has not been previously downloaded.
5.11 Test setup screens

5.11.1 General information on the test configurations
5.11.1.1 Introduction
The test setups are available from the update menu after they are transferred to the user database.
5-52
0931634-NT - October 2007
REFERENCE MANUAL

screens
5.11.1.2 User database

The user database contains specific Diagnostica Stago tests (from the reference database) and the
tests defined by the operator.
Note:It is recommended not to exceed 200 test configurations in the user's database.
5.11.1.3 Reference database

The reference database contains all the tests and products available for the analyzer.
The reference database tests are not directly useable. To be able to use them, you must transfer them
to the user database using the
button in the Test setup screen.
The user may choose all the tests of interest from the reference database and then transfer them to
the user own database. The user may also delete the pre-defined Diagnostica Stago tests from the
user own database.
When all the operations involved in changing test setups are completed, the user will need to back
up the user database using the Save function in the Maintenance menu.
The color of the test setup changes depending on its status:
Color
Status of the test setup
Gray
Only exists in the reference database.
Blue
Exists in the reference database and in the user database.
White
Selected to be updated in the user database (the letter "T" appears in front of
the abbreviation for the test that is to be updated).
Green
Transferred to the user database.
5.11.1.4 Test setup screens

The Test setup screens can be accessed in the Setup menu by clicking the
clicking the Tests tab.
icon, then
The parameters for each test setup are then distributed over 5 sections (5 tabs):
-
Methodology,
Result,
Calibration,
Printout Transmission,
QC.
5-53
0931634-NT - October 2007

screens
REFERENCE MANUAL
5.11.1.5 Incubation schemas

The incubations defined for the sample and for each reagent should correspond to one of the
incubation schemas below:
Incubation schemas
Sample = >Incubation 1 => + Rd
Sample + Ra = >Incubation 1 => + Rd
Sample + Ra + Rb = >Incubation 1 => + Rd
Sample + Ra + Rb + Rc = >Incubation 1 => + Rd
Sample + Ra = >Incubation 1 => + Rb => Incubation 2 => + Rd
Sample + Ra + Rb = >Incubation 1 => + Rc => Incubation 2 => + Rd
5.11.2 Methodology tab Test setup screens
5.11.2.1 Methology tab

Methodology tab Test setup screen
On this page of the Test setup screen, all the parameters required for analyzer operation (i.e.
aspiration, delivery, incubation, stability, methodology etc.) are defined:
-
Identification of the test (Abbreviation, Name of the test, Method, Date of last update),
Sample (Volume, Incubation, Dilution),
Diluent (Identification, Name, Shelf-life; clicking the

parameters: Vial and Min. Volume),
button provides access to other
5-54
0931634-NT - October 2007
REFERENCE MANUAL

screens
Reagents (Identification, Name, Shelf-life, Volume, Incubation, Incubation precision; clicking the
button provides access to other parameters: Vial, Min. Volume, Pre-wash, Post-Wash and
Agitation).
Incubation, to find out more, see Incubation schemas procedure in 5.11.1.5 chapter of this
manual.
Calculated tests
Calculated tests are tests for which the result is a calculation expression taking one of the following
shapes:
(M1/ M2) x k
(M2/M1) x k
(M1- M2) x k
(M2-M1) x k
M1, M2: unpeaked mean value in raw unit (sec., OD or OD/min) of two primary tests selected by
the user.
K: programmable coefficient
Thus a result can be given that is either equal to a ratio between two tests or to a difference.
The result unit is implicit. It is either the ratio in case of a ratio calculation or the raw unit in case of
a difference calculation. Therefore, secondary units do not have to be defined for calculated tests.
As far as results are concerned, calculated tests have the same presentation, edition and transmission
characteristics as regular tests.
In the test panel, a calculated test can be identified by the "Sigma" () symbol.
This kind of calculation is only allowed for primary tests based on the same type of measurement
method (chronometry, colorimetry or immunology) and using the same raw units (sec., OD or OD/
min).
The results of the calculated test appear in the test panel only when the primary tests are complete
and their results have been given.
Calculated tests and dependent tests cannot be used as primary tests. Neither can they be copied so
as to serve as source for a new calculated test.
The deletion of a caclulated test does not bring about the deletion of M1 and M2 tests. For archived
tests, the deletion of M1 or M2 tests does not bring about the deletion of the calculated test either.
On the other hand, for the samples on board, the deletion of either M1 or M2 does bring about the
deletion of the calculated test.
Moreover, they cannot be validated manually: their validation is an implicit result of primary tests
validation. The error and alarm codes given to calculated tests are the most serious error code and
the most serious alarm code of those conferred to both primary tests. Only the alarm code H (result
in main unit limited to default values) is an exception to this rule as calculated tests results are never
peaked.
The very nature of calculated tests does not allow them to be rerun. If either of the primary tests is
rerun, the calculated test is automatically rerun.
In addition, there is neither calibration nor quality control for this type of test.
For more information about the creation of calculated tests, see chapter 3.10.4 of this manual.
5-55
0931634-NT - October 2007
REFERENCE MANUAL

screens
5.11.2.2 Identification
Test abbreviation
Short name of the STAGO test, contains 8 characters at most.

The abbreviated name of the customer test must contain
7 characters at most.
Test name
Complete name of the test (used for editing the results), contains
Date of last update
Last UPDATE = date of the last change made to the test setup
(backed up by the operator).
Method
Type of measurement method.

You have the following choices:
-
Clotting,
2 pts Color. = kinetic 2 point colorimetry,
OD/min Color. = kinetic O.D./minute colorimetry,
2 pts Immu. = kinetic 2 point immunology,
OD/min Immu. = kinetic O.D./minute immunology,
5.11.2.3 Sample
Sample volume
Distributed volume of the sample (Vol.) in microlitres (including

the dilution).
Possible choices: from 25l to 200l by increments of 1l.
The total volume (sample + reagents) should be between: 150l

and 400l for the chronometric methods, 250l and 400l for
the photometric methods.
Sample incubation
Incubation time (Incu.) of the plasma alone (with or without

dilution):
0 = no incubation
30 to 999 = incubation time (in seconds)
5-56
0931634-NT - October 2007
REFERENCE MANUAL
Dilution ratio

screens
Dilution ratio of the plasma expressed as follows:

1/D with the following correspondences:
-
1 => Volume of pure plasma
D => total volume (plasma + diluent)
The choice can be made from a drop down list with

D = 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 15, 20, 30, 40, 50, 60, 80, 100,
160, 200, 400.
The 1/400 dilution is not possible for volumes of plasma less than
50l. When the dilutions are being made, the minimum quantity
of plasma that the system can sample is 5l.
5.11.2.4 Diluent
Product identification (Id.).

8 characters maximum (minimum of 1 character).
To be chosen from a drop down list or entered manually.
Product name
For products that are already known, this is displayed
automatically.
Shelf-life of product
Shelf-life of product in the STA-R Evolution in hours (Shelf-.).

This stability is controlled once the product has been loaded into
the STA-R Evolution.
For products that are already known, this information is
displayed automatically.
Vial
Vial corresponds to the original volume after reconstitution of

the vial for the product (in milliliters).
automatically.
If this information is not displayed on the screen that you are
consulting, click the
button to display the screen that
recapitulates all information about the products.
5-57
0931634-NT - October 2007

screens
Minimum volume of
product
REFERENCE MANUAL
The remaining product volume (in ml) that the STA-R Evolution
stops measurement (Min. Vol.).
automatically and may be changed.
5.11.2.5 Reagent

Product name
automatically.
Product stability on the STA-R Evolution in hours (Shelf-.).

For products that are already known, this information is displayed
automatically.
Reagent volume
Distributed volume of each reagent in microlitres (Vol.).

Possible choices: from 25 l to 200 l by increment of 1 l.
The total volume (sample + reagents) should be between: 150 l

and 400 l for the chronometric methods, 250 l and 400 l for
Reagent incubation
Incubation time (Incu.) of each reagent (from 0 to 999 seconds).

0 : no incubation.
Minimum incubation time = 30 seconds.
5-58
0931634-NT - October 2007
REFERENCE MANUAL
Incubation precision

screens
According to the override of time authorized for the incubations,

for the Prec. parameter, you will use:
: critical incubation, that is maximum override of 5 seconds.
: normal incubation, that is maximum override of 30 seconds.
Each override of incubation time will lead to the analysis being

abandoned (cuvette disposed of in the waste tray) and the
automatic rerun of the test in question. This should therefore be
reserved for truly critical incubations.
Vial

automatically.
Pre-wash
Type of cleaning to be carried out before each sampling of the

reagent in question.
Possible choices:
-
No: no pre-wash,
Spec. : special pre-wash using a decontaminating solution to

be defined and rinsing with the STA-Cleaner Solution.

Post-wash
Type of cleaning to be carried out after each sampling of the

Possible choices:
-
Norm. : normal wash using the STA-Cleaner Solution,
Inten. : 2 normal types of wash,
Spec. : special wash using a decontaminating solution to be

defined + rinsing with the STA-Cleaner Solution.
Inten. +: 2 intensive cleanings for the releasing reagent.

5-59
0931634-NT - October 2007

screens
Minimum volume of
product
REFERENCE MANUAL
Stirring
Possibility of reagent agitation in the agitated position in the

products drawer for the client products (for the STAGO
products, this option cannot be changed).
5.11.3 Results tab - Test setup screens
5.11.3.1 Result tab

Result tab - Test setup screen
All the parameters required to define the modalities of the analysis and the processing of the result
are brought together on this page of the Test setup screen.
-
Analysis (Chronometry, 2 point Kinetics, OD/minute Kinetics, Rd heating, Agitation)
Result (Main unit, correction factor, determination, maximum standard deviation, re-dilution
criteria)
Acceptance limits (acceptance values)
5-60
0931634-NT - October 2007
REFERENCE MANUAL

screens
Note: The parameters in Analysis differ according to the type of measurement (Chronometry, 2
point Kinetics, OD/minute Kinetics).
5.11.3.2 Analysis
Chronometric analysis parameters
In chronometric tests, the following parameters determine the modalities of the analysis:
-
Min. Time,
Max. Time,
Mean Time,
Clot.
Minimum time
Min. Time = lower time limit for which no result may be

yielded.
In this case, you have an M<Mmin for the result.
Choices: from 3 to 999 seconds with Min. Time < Max. Time
For 2nd and 3rd order polynomial regressions, the 2

measurements Ta and Tb (with Ta < Tb) that correspond to the
extreme concentrations of the calibrators limit the temporal field
applicable to the interpolations.
The Min. Time and Max. Time, if they are outside the field that
has been defined in this way, will be replaced by Ta and Tb
respectively.
Maximum time
Max. Time = upper time limit for which no result may be

yielded.
In this case, you have an M>Mmax for the result.
Choices: from 3 to 999 seconds with Min. Time<Max. Time.

applicable to the interpolations. The Min. Time and Max. Time,
if they are outside the field that has been defined in this way, will
be replaced by Ta and Tb respectively.
5-61
0931634-NT - October 2007
REFERENCE MANUAL

screens
Mean time
Mean Time = average estimated for coagulation times.

This is used by the software to adjust the cadence and avoid
congestion in the measurement area.
Under routine conditions, the risk of congestion is rather weak.
On the other hand, for a given test on important series of plasma
with very long coagulation times (anti-vitamin K treatment for
example), you must increase the average time so that the STA-R
Evolution slows the cadence down.
Choices: from 3 to 999 seconds with:
Min. Time<Mean Time<Max. Time.
Type of clot
Parameter acting on sensitivity in clot detection.

Possible choices:
Rd heating
NORMAL
WEAK
AVERAGE
Heating type for the start reagent.

Possible choices:
Rd heating: pre-heating of the start reagent to 37C in the
pipetting head flash heater just before distribution.
With E and F incubation schemas, the Rb (E schema) and Rc (F
schema) reagents will also be pre-heated (see "Incubation
schemas" in chapter 5.11.1.5 of this manual).
Rd heating: no pre-heating.
Stirring
Possibility of agitation by needle n3 during the distribution of the

start reagent (Rd) in the cuvette in measurement position.
Possible choices:
Stirring: Functional agitation.
Stirring: Non-functional agitation.
Note: If the intermediary reagents are distributed before the first
incubation, the mixture is systematically agitated by a lateral
movement of arm n4 before transfer of the cuvettes to the
incubation positions.
Analysis Parameters for 2 point Kinetics

In colorimetric or immunological tests in 2 point kinetic mode, the following parameters determine
the modalities of the analysis:
-
First point,
Second point,
5-62
0931634-NT - October 2007
REFERENCE MANUAL
First point

screens
First Point = time (in seconds) between the distribution of the

start reagent and the first optical reading point.
6 seconds at least for the 2-point kinetic mode.
Second point
Second Point = time (in seconds) between the distribution of

the start reagent and the second optical reading point.
600 seconds at most for the 2-point kinetic mode.
This time should be greater than the Premier point time with a
deviation of
6 seconds.
Rd heating

Possible choices:
Stirring

Possible choices:
Analysis Parameters for OD/minute Kinetics

In colorimetric or immunological tests in OD/minute kinetic mode, the following parameters
determine the modalities of the analysis:
-
Min. linearity,
First point,
Second point.
Minimum linearity
Min. linearity = minimum linearity value acceptable for each

linear regression in the context of the OD/minute kinetic mode
Choices: from 0.01 to 0.99.
Any result below this limit is assigned the Lin. error code.
5-63
0931634-NT - October 2007
REFERENCE MANUAL

screens
First point
First point = time (in seconds) between the distribution of the

4 seconds at least for the OD/minute kinetic mode.
Second point

the start reagent and the last optical reading point.
600 seconds at most (OD/minute kinetic mode).
This time should be greater than the First point time with a
deviation of
10 seconds.
Rd heating

Possible choices:
Stirring

Possible choices:
5-64
0931634-NT - October 2007
REFERENCE MANUAL

screens
5.11.3.3 Result
Primary unit
Main unit in which the results are yielded (Prim. unit) Test
setup screen
This unit is chosen in the Result tab; it is repeated in the
Printout/Transmission tab.
Possible choices:
Corrector
Raw: Sec. = Seconds, D.O. = delta of Optical density or

O.D./min. optical density per minute,
%: Percentage,
Ratio: Ratio of illness time to reference time,
g/l: Grams per litre,
mg/dl: Milligrams per deciliter,
ng/ml: Nanograms per milliliter,
U/ml: Unit per milliliter,
UI/ml: International Unit per milliliter,
g/ml: Micrograms per milliliter,
INR: International Normalized Ratio
U.A.1: Arbitrary unit n1,
U.A.5: Arbitrary unit n5.
Systematic multiplication factor that only applies to results

expressed in the main unit for yielding results.
This factor does not apply to the results of the controls.
Note: secondary results expressed in a unit other than Raw, Ratio,
INR or Reference time are calculated from the main result;
therefore they are subject to this correction factor.
5-65
0931634-NT - October 2007
REFERENCE MANUAL

screens
Determination
Determination type.
Valid for the samples and for the quality controls.
Possible choices:
-
SINGLE determination,
DUPLICATE determination,
In Duplicate determination mode, the samples are treated

concomitantly and a calculation of the average is carried out. On
the other hand, for the same mode, the quality controls are
processed individually (no calculation of the average) and the
Max. Deviation/mean parameter is not used.
Max. deviation/mean
Max. deviation/mean = maximum difference authorized when

a duplicate determination is performed.
The deviation is expressed in % (relative deviation with
respect to the average) and applies to the raw data, that is to the
times for coagulation and to the O.D. or O.D./min for
colorimetry and immunology:
Deviation/Average =
M1 - M2
x 100
M
M1, M2: raw measurements,
M = (M1 + M2)/2.
In the specific case of 2 point kinetic immunological tests, you use

an absolute deviation, which is expressed in O.D.m:
Deviation = [M1 - M2] in O.D.m
Note: the results exceeding the max. deviation are:
Redilution conditions
tagged with the "O" alarm (incorrect duplicate tolerance)
assigned the "to be validated" status
Definition of two other possible dilutions for the sample if it leaves

the linearity area.
The linearity area is defined by the <Lower limit and
>Upper limit parameters.
The re-dilution possibilities are to be manipulated with care

because they are not always compatible with the dosage principle.
Note: The re-diluted result will be displayed in all the units
defined in the methodology.
5-66
0931634-NT - October 2007
REFERENCE MANUAL
Dilution ratio

screens
Dilution rate of the plasma expressed in relation to the expression

-

D = 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 15, 20, 30, 40, 50, 60, 80, 100,
160, 200, 400.
<"Lower limit
Parameter used to define the Redilution conditions.

Definition of the lower limit of the linearity area in the main unit
for yielding the result.
The lower limit cannot be less than 0.
If this value is defined, the associated re-dilution rate should be
defined. Then any result less than this value will be automatically
rerun with the defined re-dilution rate. The result yielded takes
into account the change in dilution.
>"Upper limit

Definition of the upper limit of the linearity area in the main unit
The upper limit cannot be superior to 999.9.
defined. Then any result greater than this value will be
automatically rerun with the defined re-dilution rate. The result
yielded takes into account the change in dilution.
5.11.3.4 Acceptance values

Definition of the range of Min. and Max. values expressed in the main unit for yielding results for
which validation is carried out automatically.
Any result within this range is assigned Validated status and any result outside of this range is
assigned To be validated status, except if the result is tagged with the "O" alarm (incorrect
duplicate tolerance), see chapter 5.11.3.3 of this manual.
5-67
0931634-NT - October 2007

screens
REFERENCE MANUAL
5.11.4 Calibration tab Test setup screens
5.11.4.1 Calibration tab

Calibration tab Test setup screen
The parameters required to define the modalities of sampling for a test are displayed according to
the calibration mode chosen.
Raw mode:
Linear mode:
All the parameters required to define the modalities of sampling for a test are brought together on
this page of the Test setup screen.
5-68
0931634-NT - October 2007
REFERENCE MANUAL

screens
calibration mode,
type of determination,
measurement scales,
concentration scales,
calibrators,
offset corrector (for the colorimetry and immunology methods),
calibration controls.
5.11.4.2 Calibration mode

Definition of the calibration mode.
6 possibilities to choose from in the drop down list:
-
Linear: Linear regression on at least 2 points (Y = ax + b),
2nd order polynomial: 2nd order polynomial regression on at least 4 points (Y = ax + bx + c),
3rd order polynomial: 3rd order polynomial regression on at least 6 points

(Y = ax3 + bx + cx + d , reserved for immunological tests),
Hyperbolic: Hyperbolic regression on at least 5 points [Y = a + b / (x - N)],
Raw: Raw data (in the unit of measurement): seconds, O.D., or O.D./min,
Ratio: Ratio to a reference.
Note: depending on the type of scale chosen, x or y can become log x, log y,
If there is a pre-calibration, the
1
y
symbol is displayed.
Note: For the pre-calibrations, the data related to the calibration is transmitted by bar code labels,
a modality reserved fo the Diagnostica Stago tests.
5.11.4.3 Calibrator definition

The calibrators are only to be defined for the linear, second order polynomial, third order polynomial
and hyperbolic calibration modes.
Number of standards: from 2 to 8.
You should respect a minimum number of calibrators according to calibration mode.
The parameters required for definition of calibrators are:
- Identification,
- Key,
- Name,
- Shelf-life,
- Dilution,
- Vial,
- Min. volume
The last two parameters are visible on a recapitulating screen that you can view by clicking the
button.
Note: Calibrator identifications may be identical (use of a single calibrator) or different (use of
different calibrators). In both cases, you must specify the dilution required for each calibration point.
5-69
0931634-NT - October 2007

screens
REFERENCE MANUAL

Reading key
Reserved for Diagnostica Stago products; allows you to choose

from a list corresponding to the order of parameters printed on a
bar code sheet contained in the products kit, the test or the
Product name
automatically.
Shelf-life

automatically.
Vial

automatically.
Minimum volume of
product
Remaining product volume (in ml) from which the STA-R

Evolution should stop the measurements (Min. Vol.).
automatically.
5-70
0931634-NT - October 2007
REFERENCE MANUAL
Dilution ratio

screens

-

D = 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 15, 20, 30, 40, 50, 60, 80, 100,
160, 200, 400.
5.11.4.4 Calibrator determination

Type of determination for the calibrators.
Possible choices:
-
DUPLICATE determination, In this case, each point is considered to be an individual value.
Calibrator determination is only to be defined for the linear, 2nd order polynomial, 3rd order
polynomial and hyperbolic calibration modes.
5.11.4.5 Scales for measurements

Definition of the scales possible for the measurement axis.
Possible choices:
-
LINEAR,
LOG..
The scales for the measurements are only to be defined for the linear, second order polynomial, third
order polynomial and hyperbolic calibration modes.
5.11.4.6 Scales for concentrations

Possible choices:
-
LINEAR,
INVERSE,
LOG..
The scales for the concentrations are only to be defined for the linear, second order polynomial, third
5-71
0931634-NT - October 2007

screens
REFERENCE MANUAL
5.11.4.7 Offset corrector

The offset correction parameters only apply to the colorimetric or immunological measurement
methods and only if there is linear regression. This correction allows you to correct the Yaxis at the
origin while keeping the slope and to compensate for reagents drifting. The offset corrector must
correspond to one of the calibration standards.
The parameters required for definition of offset correctors are:
- Identification,
- Name,
- Shelf-life,
- Vial,
- Min. volume
tab.

Product name
automatically.

automatically.
Vial

automatically.
5-72
0931634-NT - October 2007
REFERENCE MANUAL
Minimum volume of
product

screens

automatically.
5-73
0931634-NT - October 2007

screens
REFERENCE MANUAL
5.11.5 Printout/Transmission tab - Test setup screens
5.11.5.1 Printout/Transmission tab

Printout/Trans. Tab. - Test setup screen
This section allows you to define all the parameters for use of units:
-
Main unit,
Secondary units,
Conversion factor,
Use for editing,
Transmission rows,
Usual values,
Editing limits.
5-74
0931634-NT - October 2007
REFERENCE MANUAL

screens
5.11.5.2 Parameters
Secondary units
Conversion factor
Definition of 3 secondary units (Aux. 1, Aux. 2 and Aux. 3) that

can be printed and/or transmitted:
-
NO (no use of this secondary unit)
Raw: Sec.: Seconds, OD: delta of optical density or O.D./

min: optical density per minute),
%: Percentage,
U.A.1: Arbitrary unit n 1,
INR:International Normalized Ratio
Ref.: reference time.
Conversion factor (Convers. Factor) between the main unit and

the secondary unit in question, when this can be applied (example
for main unit = g/l and secondary unit = mg/dl define a
conversion factor of 100).
The conversion factor, if not defined, is considered equal to 1.
The conversion factor, even if defined, is not applied whenever
the secondary unit is Raw, Ratio, INR or Reference time.
Use of unit for printout
To use main or secondary units when printing results, two choices

are possible (Printout column):
Unit used or result printed out using this unit.
Unit not used, or result not printed out using this unit.
This option applies also to the result display in the patient files.
5-75
0931634-NT - October 2007
REFERENCE MANUAL

screens
Transmission Test
Number
To use main or secondary units, you indicated the transmission

row corresponding to the server if the unit is used, that is:
transmission of the result expressed in this unit.
If the unit is not used in transmission, you must indicate 0 (
key).
Note: To request tests from the server (downloading a work list),
you must only use the row corresponding to the main unit.
You can print the list of transmission rows for the test setups
located in the client database to facilitate setup of the server.
" Click the
Usual values
icon.
Definition of the range of usual values in the main unit and in the
secondary units when the latter are defined.
5.11.5.3 Printout Limits

Definition of the range of acceptable values for any result in the main unit for yielding results.
Any result outside of this range is automatically yielded according to the context: either equal to the
minimum value (Min.) or equal to the maximum value (Max.) and is accompanied by an alert code.
5.11.6 Quality Controls tab - Test Setup screens
5.11.6.1 Quality Control tab

Quality Control tab - Test setup screen
5-76
0931634-NT - October 2007
REFERENCE MANUAL

screens
You should define 0 to 3 controls that will be integrated in the quality control files: Level 1, Level 2,
Level 3.
The parameters required for definition of quality controls are:
-
Identification,
Key,
Name,
Shelf-life,
Vial,
Min. volume
Running time.
5.11.6.2 Control Level

Reading key

from a list corresponding to the order of parameters printed on
a bar code sheet contained in the products kit, the test or the
Product name
automatically.
5-77
0931634-NT - October 2007

screens
REFERENCE MANUAL

Vial

automatically.
Minimum volume of
product

automatically.
5.11.6.3 Period quality controls taken

Definition of the period the controls were taken that is valid for all levels of quality controls.
3 possibilities are provided:
-
time interval (in hours),
number of tests,
at each change of vial.
You can choose a single type of period or aggregate 2 or 3
5-78
0931634-NT - October 2007
REFERENCE MANUAL

screens
5.12 Global Options screen

5.12.1 Global Options screen
The Global Options screen can be accessed using the

clicking the Global Options tab.
icon in the Setup menu, and then
This screen allows you to define some parameters that are specific to the laboratory.
These parameters concern:
-
Editing (definition of the laboratory identification),
Languages,
Dossier completion,
Entry of calibration parameters,
Miscellaneous options,
Definition of arbitrary units,
Regression coefficient (value from which the calibration will be validated automatically).
You need to click the

Options screen.
button to be able to change the parameters of the Global
5.12.2 Titles 1 and 2

2 lines of 34 characters to define the identification of the laboratory as it appears when printing
results.
5-79
0931634-NT - October 2007

screens
REFERENCE MANUAL
5.12.3 Languages
Possibility of changing the language of the interface: French, Italian, Spanish, English, German,
Portuguese, Danish or Swedish.
5.12.4 File Entry: Parameter for patient file acquisition

Each patient file is always located by its identification (16 alphnumeric characters maximum).
The laboratory may define 4 other complementary patient information fields to use as it wishes,
taking into consideration the fact that the number of alphanumeric characters per patient information
field is defined as follows:
Patient information field 2
16 alphanumeric characters
The complementary information can be the name or the first name of the patient, or even the
department of the consulting doctor, etc.
This information is displayed in the Test Panel, in the Patient File Acquisition screen and in the
Patient File screen.
5-80
0931634-NT - October 2007
REFERENCE MANUAL

screens
5.12.5 Miscellaneous
General parameters
In this section, you define the following general parameters:

-
The Desorb by default,
The use of the audible alert,
The use of linear extrapolation,
The possibility of having automatic reruns,
The possibility of printing the alerts,
The possibility of automatically unloading the racks once the

analyses have been performed,
The possibility of printing online,
The possibility of transmitting all the results or only validated

results online,
The possibility of administering unread tubes: automatic

unloading of unread tubes so that they can be re-identified.
Desorb by default
Alphanumeric identification of the decontaminating solution to be

used by default every time the analyzer is started as well as every
time the analyzer starts a series of tests or enters dormancy.
Audible alarm
Possibility of generating an audible alert when an anomaly is

detected.
Audible alarm: Activated audible alert,
Audible alarm: Non-functional audible alarm.
Linear extrapolation
For all linear mode calibrations, the possibility of extrapolating

outside extreme points of the calibration.
When the linear extrapolation is activated, there is no limit to the
calculation of the results.
When the linear extrapolation is deactivated, patient and QC
results are calculated to the max. and min. measurement given by
the calibration.
Linear extrapolation: Extrapolation possible,
Linear extrapolation: Extrapolation impossible.
Note: for the modes of graphical calibration in 2nd and 3rd order
polynomial:
-
the extrapolation is never allowed
the patient results and QC are calculated to the min. and max.
measurement limit given by the calibration
5-81
0931634-NT - October 2007

screens
Automatic rerun
REFERENCE MANUAL
For all tests, the possibility of automatic rerun if there is a

technical error in time < minimum time or time > maximum
time.
Automatic rerun: Tests rerun automatically,
Automatic rerun: No automatic rerunning of tests.
Note: if the Automatic rerun option is not selected:
Alarm printout
tests in error do not bring about any rerun or redilution
tests with no error do not bring about any rerun but, they do
bring about a redilution when all the conditions for a redulition
are met
Possibility of including or not including the alerts related to the

tests when printing results.
Alarm printout: Results printed with alert(s),
Alarm printout: Results printed without alert.
On line transmission
Possibility of automatically transmitting test results at the end of

the measurements. When automatic transmission is activated,
possibility of only transmitting the validated results.
All Results: all the results (except for calibration) are
automatically transmitted to the server as soon as they are
available,
Only Validated Results: only the validated results are
automatically transmitted (results to be validated or erroneous
results are not automatically transmitted).
5.12.6 Arbitrary Units

For internal use, the laboratory may create up to 5 arbitrary units. These units can be used either as
the main unit or as a secondary unit.
The abbreviation for the unit (Name) can be defined using up to 5 characters.
The number of characters after the period (Dec.) should be defined.
Reminder: Every result is generated in 5 characters including the period.
The choices possible for the Dec. parameter are: 1, 2 or 3.
5-82
0931634-NT - October 2007
REFERENCE MANUAL

screens
5.13 Communications screen

5.13.1 Communications screen
The Communications screen can be accessed in the Setup menu by the

the Communications tab.
icon, then clicking
This screen allows you to define the parameters required for transmission of the results to a server.
The protocol used is ASTM.
-
The type of protocol (strict or extended),
The station number,
Transmission speed (300, 600, 1200, 2400, 4800 or 9600 bauds),
The type of parity (None, Even or Odd),
The number of DATA bits (7 or 8),
The number of STOP bits (1 or 2),
The number of trials should there be an error
The display of the symbol ( or u).

Communications screen.
button to be able to change the parameters of the
5-83
0931634-NT - October 2007

screens
REFERENCE MANUAL
5.13.2 The number of trials should there be an error

Dispatch number of a screen sent by the STA-R Evolution when a NACK message is received.
Possible choices: from 1 to 9.
5.13.3 Station number

Number allowing the server to identify the STA-R Evolution.
Choices: from 0 to 99.
5.13.4 Protocol type

The possibility of choosing between an ASTM protocol that is strictly identical to the one used on
STA and on STA Compact and a protocol likewise based on ASTM but using more possibilities.
Possible choices:
-
Strict: protocol identical to the STA /STA Compact ,
Extended: protocol with more possibilities.
5.13.5 Transforming the character

The ASCII character "" (micro) may be transformed into a "U" in the ASTM frames for the
transmission of results units and of notes associated to patients files.
The default option does not imply the transformation of the character "" during the transmission.
5-84
0931634-NT - October 2007
REFERENCE MANUAL

screens
5.14 Passwords screen
The laboratory may decide to reserve access to some functions of the software to specific people.
Each individual category found in the Passwords tab can be password protected. These passwords
are limited to a maximum of 6 characters. The user may first type in the Administrator password
in order to gain access to the Passwords tab.
When a password is attributed to a function, access to this function requires entry of the
corresponding password in the window that is displayed.
Before defining the various codes, carefully read the chapter 1.6 of this manual.
5-85
0931634-NT - October 2007

screens
REFERENCE MANUAL
5.15 Status - Counters screen
The Status - Counters screen allows you to view or administer some of the analyzer's parameters.
This screen is displayed by clicking the

button located in the system panel (lower right
portion of the screen). The user may access this screen at any time during any of the operations
screens.
5.15.1 Temperatures
Reagents Drawer: the temperature should be between 15C and 19C. If temperature is outside
of the recommended range, NOK (Not OK) is displayed against a red background, otherwise OK is
displayed against a black background.
Reagents arm 3 and Measuring block: if temperature is outside of the recommended range, it is
displayed against a red background, otherwise it is displayed against a black background.
5.15.2 Level detection management

This option allows you to activate or deactivate the level error administrator arm by arm (activated
option by default).
If the option is deactivated (cleared checkbox), the test results are marked by an alert
(E = arm 3, F = arm 2, G = arm 1).
If an analyzer is equipped with a plug piercing system, this option is not available for arm 1.
5-86
0931634-NT - October 2007
REFERENCE MANUAL

screens
5.15.3 Versions
Allows you to view the version of the STAPLUS software and the version of the eproms located on
the cards in the PC rack.
5.15.4 STAR serial number

Allows you to view the serial number of the analyzer.
5.15.5 Timer
Allows you to view the total length of operation of the machine (in hours) since its installation.
5.15.6 Suction pad

Allows you to view the total number of contacts carried out since the last change of suction cup.
The counter starts at 0 once the suction cup has been changed.
5.15.7 Availability before maintenance

The values displayed correspond to the number of cycles made by the piercing needle.
The value indicates the percent remaining until pipette maintenance is required.
When the values are displayed in red, it is necessary to perform the appropriate maintenance.
Number of piercings:
The counter starts from 100,000 and decreases. When the counter reaches 0, the value is displayed
in red. It is then necessary to change the needle (refer to chapter 4.8.1 of this manual). If the needle
is not changed, further test results are marked with an alert (N = Syringe arm 1 maintenance date
elapsed). The counter restarts from 100,000 after the needle is replaced.
Pipettings:
The counter starts from 100%. When the counter reaches 0%, the value is displayed in red. It is then
necessary to change the syringe tip and joint O-Ring in question (refer to chapter 4.5.1 of this
manual). If they are not changed, further test results are marked with an alert (L = Syringe arm 3
maintenance date elapsed, M = Syringe arm 2 maintenance date elapsed, N = Syringe arm 1
maintenance date elapsed). The counter restarts at 100% after the maintenance is performed.
5.15.8 Cuvettes
Allows you to view the code number of the reel and the number of cuvettes that are left in the reel.
This information is displayed permanently on the Products tab.
5-87
0931634-NT - October 2007
REFERENCE MANUAL

screens
" To load a new cuvette roll, click the

button then follow the procedure described in chapter
5.15.9 Cleaner Solution

Allows you to view the quantity of cleaning solution available. This information is displayed
permanently on the Products tab.
" To load a new 2.5 liter bottle of cleaning solution, click the
procedure described in chapter 3.3.3 of this manual.
button then follow the
5.16 CD/DVD recorder screen

This window is displayed during the back-up of data on a CD or DVD (only if the analyzer is equipped
with a CD/DVD recorder)
Discs name:
The serial number of the analyzer is automatically displayed in this field.
This data will not be editable afterwards.
Erase:
This operation may take a long time.
Allows the deletion of a CD-RW (click
) before using it to record data.
Action:
-
A click on
allows to close the window.
A click on
allows the burning of a CD-R, CD-RW or DVD-R.
5-88
0931634-NT - October 2007
REFERENCE MANUAL

screens
Preserve the contents of the disc: do not clear this check box otherwise, the data already recorded
in the CD/DVD will be deleted.
When "100% burnt" appear at the bottom of the screen, this does not mean that the back-up is
complete. The back-up is complete only when the message "Burn succeed" appears.
The word "media" appearing in the window stand for "storage medium" (CD-R, CD-RW or DVDR).
Note:
The recorded files are stored in a directory named after the menu of origin of the recorded file. For
example: BackUpRestore, Tracking, TDEX, ExportCQs.
Each recorded file is stored in a subdirectory named with the date and hour of the record (aaaaamm-jj hh-mm).
5-89
0931634-NT - October 2007

screens
REFERENCE MANUAL
5-90
0931634-NT - October 2007
REFERENCE MANUAL
Content
Troubleshooting
6.1
Error messages displayed in windows . . . . . . . . . . . . . . . . . . . . . . . . . 1
6.2
Specific messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
6.2.1
Message concerning the cuvettes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
6.2.2
Message concerning the buffer vial . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
6.2.3
Message concerning the measurement system . . . . . . . . . . . . . . . . . . . . . . . 3
6.2.4
Message concerning overlapping windows . . . . . . . . . . . . . . . . . . . . . . . . . . 4
6.3
Problems observed in the results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
6.3.1
List of points to check . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
6.3.2
Description of tests in error displayed on the test panel . . . . . . . . . . . . . . . . 4
6.3.3
Detailed description of a technical error . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
6.3.4
Typical problems in the results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
6.4
Problems connected to running analyses . . . . . . . . . . . . . . . . . . . . . . 8
6.5
Other problems observed . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
6.5.1
Problems in implementation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
6.5.2
Problem connected to STA-R Evolution shutting down . . . . . . . . . . . . . . 10
6.5.3
Various problems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
6.5.4
Filter replacing procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
.......................................... 1
1
0931634-NT - October 2007
Content
REFERENCE MANUAL
2
0931634-NT - October 2007
REFERENCE MANUAL
Troubleshooting
6 Troubleshooting
6.1 Error messages displayed in windows
Type 1:
"Run time error xxx at................"
Or
"Disk error............................"
"Fatal error.............................."
Type 2:
"Critical error
Problem reading [address] [file name]"
"Index outside limit
(0), (-1) or (-2)"
""" is not a correct integer value"
"Access violation # [address] [module name]"
Type 3:
A message is displayed in a pop-up window.
Example:
Procedure to follow if a message appears:

" Record the error displayed for type 1 or 2 messages; print out the type 3 messages.
" Describe the context before the message appeared and what caused the message to appear.
" Depending on the message displayed, click
or
to continue, or
to stop.
" If the problem persists, shut down the STA-R Evolution according to the usual procedure (see
procedure in chapter 3.11.1 of this manual), wait 3 minutes and then turn the analyzer on again
" If the problem still persists, call the hotline and report the information given in the screen.
6-1
0931634-NT - October 2007
Troubleshooting
REFERENCE MANUAL
6.2 Specific messages

6.2.1 Message concerning the cuvettes
Observe the safety measures for handling biohazardous products.
Example:
The user needs to lift the transparent cover and examine the measurement block and incubation
areas. Manually remove any stray cuvette(s) that maybe left here. Use the tweezers tool found in the
accessory kit to carry out this operation. After the stray cuvette(s) have been removed, close the
transparent cover. Make sure the tweezers tool is decontaminated using the decontaminating
solution.
Probable cause(s)
Possible solution(s)
Defective suction tip.
" Proceed with cleaning the suction cup (see

procedure in chapter 4.4.8 of this manual).
" Change it if necessary (see procedure in
chapter 4.8.2 of this manual)
Ball or fragments of broken cuvettes

present in the measurement or incubation
well that causes the cuvette to be poorly
positioned.
" Access the Maintenance menu
Grip filter.

Damaged cuvette.
" Remove the cuvette.
" Open the transparent cover.

" Remove the ball or the fragments of broken
cuvettes.
6-2
0931634-NT - October 2007
REFERENCE MANUAL
Troubleshooting
6.2.2 Message concerning the buffer vial
Example:
Probable cause(s)
STA-Cleaner solution bottle empty
" Replace it if necessary (see procedure in

chapter 3.3.3 of this manual).
Grip filter

6.2.3 Message concerning the measurement system

If a photometry error is detected during photometer measurement, any pending photometric tests
will be suspended. The
icon appears in the System Panel. Double clicking this icon will allow
you to display a more detailed description of the error. One of the following messages will then
appear in the Photometer Error(s) window:
Message
Probable cause
Possible solution
Lamp Error
The light level of the lamp is too

weak or too strong.
Replace the lamp (see

procedure in chapter 4.8.3 of
this manual).
Overrun
Mechanical problem
Call the hotline
6-3
0931634-NT - October 2007
Troubleshooting
REFERENCE MANUAL
Motor failure
Motor problem
Call the hotline
Unknown
Unknown problem
Call the hotline
When there is a problem with the photometer, all the colorimetric and or immunological tests are
blocked. You must resolve any photometric problems (see possible solutions above) prior to rerunning any photometric tests.
6.2.4 Message concerning overlapping windows

In some cases, on screen overlapping windows can lead to software lockups. The user can no longer
close windows or validate commands in them.
" Click the
icon to close each window or validate its commands.
6.3 Problems observed in the results

6.3.1 List of points to check
When you observe a problem in the results, you should do the following:
" Check the rinsing volumes (see procedure in chapter 4.4.5 of this manual),
" Carry out a quality control and a check of its value against the previous values.
" Check the test setup menu: select the test in question. Examine each parameter in the Test
Setup menu and compare it with the methodologies recommended by Diagnostica Stago.
" Check the reagents: reconstitute and load new vials of reagent(s) etc.
" Run a second quality control. Check its value against the previous values.
" When running single result assays, check the results of other routine tests.
" Check that the weekly and monthly maintenance has been properly carried out.
6.3.2 Description of tests in error displayed on the test panel

See chapter 5.4.7 of this manual.
6.3.3 Detailed description of a technical error

When a test is erroneous (Error is displayed in the control panel), you can have a detailed description
of the technical error generated.
" Double click Error.
6-4
0931634-NT - October 2007
REFERENCE MANUAL
Troubleshooting
" In the menu that appears, click one of the two options available:
- Error... : for a single measurement,
- Error #x... : for a double measurement (x = measurement row)
The description of the error is displayed.
" Write down the error code (located at the bottom right of the window) to send it to the hotline
if necessary.
" Press the Return key, the space bar or the
icon to close the window (If no action is taken,
the window will automatically close after 30 seconds).
6.3.4 Typical problems in the results

The examples below are expressed in coagulation time and concern 3 routine mixed tests (patient
by patient)
6-5
0931634-NT - October 2007
REFERENCE MANUAL
Troubleshooting
TQ time
TCA time
Fibrinogen
time
Probable
cause(s)
OK
Short or long
OK
Poor pipetting
in needle n2
" Check rinsing of

needle n2 (see
procedure in chapter
4.4.5 of this manual).
" Clean needle n2 using
the mandrel punch
(see procedure in
chapter 4.4.2 of this
manual).
Contamination
of needle n2

the mandrel punch
(see procedure in
manual).
" Check needle n2s pit
suction in opening
(see procedure in
manual).
" Call the hotline
Short
Short
OK
Contamination
of needle n3
" Ensure opening of

needle n3 using the
mandrel punch (see
suction in opening
(see procedure in
manual).
contaminated
STA-Desorb
U
OK
OK
Long
Poor sample
pipetting
(dilution)
" Change the STADesorb U vial

" Call the hotline
" Check rinsing of
needle n1 (see
" Unstop needle n2
using the mandrel
punch (see procedure
in chapter 4.4.2 of this
manual).
" Call the hotline
6-6
0931634-NT - October 2007
REFERENCE MANUAL
Troubleshooting
TQ time
TCA time
Fibrinogen
time
Probable
cause(s)
Short or long
Short or long
Short or long
Poor pipetting
in needle n3
" Check rinsing of

needle n3 (see
" Unstop needle n3
using the mandrel
manual).
" Replace the teflon tip
of the syringe (see
" Call the hotline
6-7
0931634-NT - October 2007
Troubleshooting
REFERENCE MANUAL
6.4 Problems connected to running analyses

Type of problem
Probable cause(s)
For a given test, the

analyses are not
carried out.
The test has been blocked:
" Unblock the test.
The
icon is displayed in the
Test panel for this test.
Products used to perform this test

are missing:
-
The
icon is displayed in
the Test panel for this test.
The
icon is displayed and
flashes in the Test panel.
There is no validated calibration for

this test:
-
The
The
icon is displayed
and flashes in the Test panel.
" Double click the

icon to
display the Product Forecast
screen: the missing products
are displayed in red.
" If necessary, load the missing
products.
" Double click the

the Test panel:
icon in
The Product Forecast screen

is displayed if the calibration
cannot be carried out because
of missing products or if the
barcode sheet corresponding
to the vial on board has not
been read,
The Calibration screen is
displayed if a calibration is to be
validated.
" Read the barcode sheet of the
products on board.
" Run the calibration for this test.
" Run a quality control for this
test.
6-8
0931634-NT - October 2007
REFERENCE MANUAL
Troubleshooting
Type of problem
Probable cause(s)
No analysis is
carried out.
The sampling has been blocked:
" Unblock all tests:
Either:
-
the
Test panel
The
Or:
-
by tagging all the files: clicking

each test column heading then
Unblock
" If necessary, reload the missing

products.
" Carry out the missing
calibrations.
The
icon is displayed for all
tests to be performed.
STA-Desorb U not found in

drawer:
-
icon if it is
displayed,
and
-
by clicking the
the
and
icons are
displayed and flash in the Test
panel.
" Double click the

icon;
the reason the tests were
blocked is described:
"Blockage Desorb
missing..."
or
" Double click the
icon to
" Load a vial of STA-Desorb U
in R0, R1 and R2.
6-9
0931634-NT - October 2007
REFERENCE MANUAL
Troubleshooting
6.5 Other problems observed

6.5.1 Problems in implementation
Problems observed
Probable cause(s)
Black screen, no response

from the keyboard and the
STA-R Evolution does not
start.
Power supply is not connected.
" Properly connect the

power supply
The wall socket or the extension

socket is out of order.
" Connect the STA-R

Evolution to another
power outlet.
The main fuses have blown.
" Change the main fuses.
The analyzer is out of order.
" Call the hotline
6.5.2 Problem connected to STA-R Evolution shutting down
Problem observed
STA-R Evolution Software does not respond
" Simultaneously press the keys

Ctrl + Alt +S
If this does not work:
Ctrl + Alt +F10
Note:
If tests were running before an emergency shutdown, they are automatically rerun upon the
software restart.
If results were displayed before an emergency shutdown, they are automatically displayed again
upon the software restart.
6.5.3 Various problems

Problem printing bar codes:
The last labels are partially printed.
6-10
0931634-NT - October 2007
REFERENCE MANUAL
Troubleshooting
Probable cause(s)
Incorrect printer setup.
" Check printer setup using the button.
" Change the paper to a standard paper size.

Problem reading tubes:
Probable cause(s)
Poorly positioned label.
" Check that the recommendations below are followed:

-
Stick the label on to a clean tube,
The bars on the label should be perpendicular to the axis

of the tube:
RIGHT
WRONG
The position of the label on the tube should conform to

the following dimensions:
If there are already labels on the tubes, you must cover all
the existing bar codes when you apply the new label.
6-11
0931634-NT - October 2007
Troubleshooting
REFERENCE MANUAL
Problems associated to operation of the touch screen:

A significant electromagnetic field can disrupt operation of the screen. If there is a problem, contact
the Hotline.
6.5.4 Filter replacing procedures

Liquid filter replacement procedure:
Ref. : 27458
" Click the
icon.

" Remove the 2.5 liter bottle of STA-Cleaner Solution.
" Replace the A marked filter and dispose of the old one according to the regulations locally in
force.
Note: The message "The Bottle of Cleaner is missing" may be displayed.

" Replace the 2.5 liter bottle of STA-Cleaner Solution.
" Close the message if it was displayed.
" Proceed with purging the needles so as to dispose of possible bubbles in the circuit (see
Grip filter replacement procedure:
Ref. : 27458
" Click the
icon.

" Open the top right side door.
6-12
0931634-NT - October 2007
REFERENCE MANUAL
Troubleshooting
" Replace the filter marked A and dispose of the old one according to the regulations locally in
force.
" Close the top right side door.
End of document
6-13
0931634-NT - October 2007
Troubleshooting
REFERENCE MANUAL
6-14
0931634-NT - October 2007
REFERENCE MANUAL
Index
A
Acceptance thresholds . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-26
Alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-59, 5-10
Audible alert . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-81
Archives . . . . . . . . . . . . . . . . . . . . . . . . . . 3-3, 3-78, 4-35, 4-37, 5-8, 5-14
ASTM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-18, 5-83 5-84
Automatic
Identification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-34
Automatic identification . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-35 3-36, 3-41
Automatic profile . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-34, 3-41
Automatic rerun . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-82
B
Back up
Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-35
Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-38
Bar code label . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-34
Bar code reader . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-18
C
Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-70, 5-34, 5-36, 5-68
Interpolated results for the calibrators . . . . . . . . . . . . . . . . . . . . . . . 5-39
Meaning of the colored triangles . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-35
Raw measurements for the calibrators . . . . . . . . . . . . . . . . . . . . . . . 5-38
Theoretical concentration of the calibrators . . . . . . . . . . . . . . . . . . . 5-38
CD/DVD recorder . . . . . . . . . . . . . . . . 2-5, 4-36, 4-39, 4-45, 4-51, 4-54
Chronometry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-6
Cleaner solution . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-12, 5-88
Clot . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-6, 5-62
Colorimetry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-17
Condensation trap . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-2
Cuvette . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-11
Loading the cuvette reel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-8
Number of cuvettes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-87
Cuvette disposal bag . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-11
Cuvette disposal bin . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-11
Cuvette reel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-11, 3-8
Tracking . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-8
D
Daily Controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-26, 5-43
Daily total . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-43 5-44
1-1
0931634-NT - October 2007
Index
REFERENCE MANUAL
Date (setting) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1

Decontaminating solution. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-33
Decontamination
Decontamination procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-33
Detection of level . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-12, 5-86
Dilution . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-57
Diskette drive . . . . . . . . . . . . . . . . 2-5, 4-35, 4-39, 4-45, 4-50, 4-54, 5-6
Duplicate
Assay . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-56
E
Error message . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-1
Concerning the buffer vial . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-3
Concerning the cuvettes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-2
Processing an error message . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-1
F
Fuse . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-30 4-31
G
Grip . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-13, 5-87
Grip filter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-12
I
Icon . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-3
Immunological
Measurement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-6 2-7
Immunology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-17
Incubation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-9, 2-11
Incubation block-measurement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-11
INR . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-76, 5-65
Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1
Insufficient quantity of plasma . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-5, 5-15
Intermediate reagent . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-9
Intermediate reservoir . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-16
ISI . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-76, 5-34
K
Kinetics
2 point Kinetics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-62
DO/minute Kinetics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-63
Knurled nut . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-25
1-2
0931634-NT - October 2007
REFERENCE MANUAL
Index
L
Language of the interface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-80
Linear extrapolation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-81
Loading
Cleaner solution . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-12
Cuvette reel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-8
Products . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-11, 3-15, 5-24
Samples . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-9, 3-32, 5-19
Urgent sample . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-40 3-41
M
Main
Re-diluted . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-52
Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-80 3-81
Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1
Decontamination . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-33
Schedule of preventive maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . 4-2
Telemaintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-40
Maintenance utility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1
Mandrel punch . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-6, 4-33
Manual identification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-36, 3-38
Mapping . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-24
Measurement plate
Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-13
Error message . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-3
Monthly total . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-43, 5-45
N
Note . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-50 5-51
O
Off . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1
Offset corrector . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-72
On . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-82
Optical density . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-17
O-ring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-16
P
Panel
Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-2
System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-2
Password . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-41, 5-85
1-3
0931634-NT - October 2007
Index
REFERENCE MANUAL
Patient dossier
Archiving . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-78
Routine administration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-48
Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-22
Urgent patient dossier . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-65
PC Anywhere . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-40
Pediatric . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-32, 3-50
Photometric graph . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-61
Plunger . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-8
Problem
Implementation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-10
Running analyses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-8
Shutting down the instrument . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-10
Purging the needle . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-10 4-11, 6-12
Q
QNS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-5, 5-15
Quality control
Comments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-6, 3-24 3-25
comments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-32
Control Level . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-77
Threshold values . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-31, 5-39
R
Rack
Administration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-42
Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-20
Rack conveyor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-20
Reference time . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-76, 5-34
Releasing reagent . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-9, 3-4
Reloading the racks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-6, 3-46
Remote link . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-40
Repeatability . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-17, 5-20
Restoring data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-36
Result
Back up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-35
Graph . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-61
Status . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-52
Results status
Color code . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-14
List of possible statuses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-52
Symbols used in the control panel . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-18
Rinse solution . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-12, 5-88
1-4
0931634-NT - October 2007
REFERENCE MANUAL
Index
S
Screen
Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-3
Reading . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-1
Shut down
Emergency shutdown . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-4, 5-3
Prolonged shut down . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-85
Routine shut down . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-84
Shuttle transporter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-14
STA-Microcups . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-16, 5-29
Standard deviation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-45
Stirring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-11, 3-5, 5-28, 5-60
Suction tip . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-9
Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-13
Replacement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-28
suction tip . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-5
T
TDex . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-38
Teflon tips . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-15
Telemaintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-40
Test profile
Automatic profile . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-34
Defining a profile . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-50
Using a profile . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-52
Thumb screw . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-12, 4-16, 4-29
Time (setting) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1
Transmission
Identification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-82
Online . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-82
Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-1
U
Unit
Arbitrary units . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-82
Choose the unit for display in the control panel . . . . . . . . . . . . . . . . 3-69
Main unit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-65
Unread tube . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-3, 5-81
Urgent . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-65
V
Vacuum pump . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-2
1-5
0931634-NT - October 2007
Index
REFERENCE MANUAL
W
Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2, 3-15
Work list . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-35, 3-53
1-6
0931634-NT - October 2007
REFERENCE
MANUAL
FOR ANY INFORMATION, PLEASE CALL

(NAME AND ADDRESS OF THE SUPPLIER):
Diagnostica Stago S.A.S - 9, rue des Frres Chausson - 92600 Asnires (France)
www.stago.fr- Contact: stago@stago.fr - RCS Nanterre - N B 305 151 409
80189
0931634
Information contained in this document, in particular data, pictures, information, trademarks and logos are
protected by copyrights and other intellectual property rights 2007, Diagnostica Stago, all rights reserved 10-2007.
Consequently, all representation and/or reproduction, whether in part or in full, is forbidden and would be
considered a violation of Diagnostica Stagos copyrights and other intellectual property rights.
REFERENCE MANUAL
REVISION TABLE
Manual
Version
0931634
Date
October 2007
Software Version
3.01
List of modifications
Creation
1-1
0931634 - October 2007
REFERENCE MANUAL
1-2
0931634 - October 2007
REFERENCE MANUAL
Content
Chap 1: Warnings and symbols

Chap 2: Introduction
Chap 3: Routine use
Chap 4: Maintenance
Chap 5: Detailed description of the software screens
Chap 6: Troubleshooting
1
0931634 - October 2007
Content
REFERENCE MANUAL
2
0931634 - October 2007
REFERENCE MANUAL
Content
1.1
Meaning of the symbols used in STA-R Evolution . . . . . . . . . . . . . 1
1.2
General warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
1.3
Warnings regarding the use of biological products . . . . . . . . . . . . . . 2
1.4
Warnings regarding test settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
1.5
Bibliography - Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
1.6
Warnings regarding the use of access security . . . . . . . . . . . . . . . . . . 4
1.7
Warnings regarding the STA-R Evolution system . . . . . . . . . . . . . . 5
1.8
Warning regarding the analyzer disposal . . . . . . . . . . . . . . . . . . . . . . . 6
.................................... 1
1
0931634 - October 2007
Content
REFERENCE MANUAL
2
0931634 - October 2007
REFERENCE MANUAL
1 Warnings and symbols

1.1 Meaning of the symbols used in STA-R Evolution
On the analyzer
Alternating current
Direct current
Protection earth
Warning, consult the

accompanying documents
Off (turn current off)
On (turn power on)
Biohazardous element
Dangerous voltage
Medical equipment for in vitro

diagnosis
Name and address of

manufacturer
Do not turn by hand
Separate collection: do not

discard with other waste.
Product put on the market
after 13/08/20051
1 See chapter 1.8 for additional information about the disposal procedure.
Consumables
Use once only
Keep away from magnetic

fields
Disposable gloves mandatory
Mask and goggles must be

worn
Liquid that may be

contaminated biologically
Temperature limits for

preservation
In the documentation
Warning, important
information

Result of an action
Complementary information
"
Action to be performed
1-1
0931634 - October 2007
REFERENCE MANUAL
1.2 General warnings

The use of the STA-R Evolution system requires training provided either by Diagnostica Stago or
by one of its official distributors.
In order to ensure the correct operation of the STA-R Evolution system, it is imperative to
acknowledge and to comply with any and all of the analyzer, warnings, instructions and procedures
contained in this manual.
The compliance with any and all local legislations, regulations and norms related to biological acts
and/or to medical biology laboratories applicable in the territory where the STA-R Evolution system
is installed is required and in particular, for France, the GBEA (Guide to Correct Performance of
Medical Biology Analyses) published in its most recent version, the decree of April 26th 2002 (JO
[Journal Officiel] May 4ths 2002 n104), and for the United States, the CLIA-88 in the most recent
version (Clinical Laboratory Improvement Act of 1988).
All information, warnings, instructions and procedures contained in this manual and/or in all later
versions updated by Diagnostica Stago as well as all legislation, regulations and norms relating to the
use of medical in vitro diagnostic equipment in force and applicable for users locally (by locally, we
understand the territory in which the STA-R Evolution system is installed) are hereinafter
collectively referred to as the Recommendations.
Under no circumstances Diagnostica Stago, its employees, its suppliers or a third party mentioned in
this manual shall be liable whether in contract, tort including, but not limited to negligence or
otherwise for any special or consequential damages, damages or losses that result from the security
and the efficacy of the STA-R Evolution system as well as any damage whatever, direct, indirect,
material or immaterial, incidental or accessory, or of any nature whatever or of any prejudice, in the
non restrictive cases listed hereunder:
(i) in case of non respect of the recommendations described in this manual as well as the use of
procedures that are not set forth by Diagnostica Stago,
(ii) in case of use of reagents other than those manufactured by Diagnostica Stago even if the use of
said reagents associated with the STA-R Evolution system is specified in an adaptation protocol,
(iii) in case of use of tubes other than those specifically listed in chapter 2 of this manual,
(iv) in case of use of washed and/or re-used cuvettes, the reacting cuvettes being consumables
intended for a single use, as well as cuvettes other than those manufactured by Diagnostica Stago and
commercialised by Diagnostica Stago and/or by its official distributors,
(v) in case of non accomplishment of the current and regular maintenance operations, calibration and
support operations set forth in the present manual and permanently required to ensure the correct
functionning and security of the STA-R Evolution system,
(vi) in case the STA-R Evolution system is not decontaminated in accordance with the
decontamination procedures set forth in chapter 4.9.1 of this manual.
1.3 Warnings regarding the use of biological products

For how to handle reagents, calibrator plasmas, control plasmas, and patients plasmas (hereinafter
referred to as Products), carefully read the notes that come with each Product.
Prior to any intervention in the STA-R Evolution system, to ensure that the personnel working in
contact with biological products are protected, and to allow a proper execution of the biological
assays, please comply with the following measures:
1-2
0931634 - October 2007
REFERENCE MANUAL
(i) respect all recommendations,

(ii) be sure to decontaminate the STA-R Evolution in accordance with the procedures identified in
this manual (see chapter 4.9.1),
(iii) respect all norms and safety measures imposed on laboratories for performance of biological
analyses connected with biohazardous Products in accordance with the regulations in force locally.
For example, the following precautions should be taken:
-
Do not eat, drink or smoke on the premises where these Products are handled,
Consult a doctor immediately if these Products are ingested or put into contact with mucous
membranes or skin lesions (wounds, cuts, etc.),
Use disposable gloves and handle all these Products as a potential source of infection,
Dispose of all these Products as if they were infected, in accordance with the legislation and the
regulations in force locally (for example: autoclaving, incineration of disposable material,
elimination of liquid waste, see the card ref. 0931066x "Liquid waste management" or local
regulations in force).
1.4 Warnings regarding test settings

Not following the conditions connected with the test configurations may have
consequences on the reliability of the results, as well as on performance of any biological
analysis using the STA-R Evolution system, therefore the following conditions should be
observed:
-
Pre-analysic conditions regarding samples: to maintain the activity of various coagulation

factors, the sample should be taken with care and following the professional standards in tubes
with a specified concentration of citrate.
You should next make sure of centrifuging quality then sample preservation temperature prior to
sample analysis:
- hemolized and partially coagulated plasma (presence of micro-clots), plasma that was damaged
by temperature changes or plasma with bubbles on its surface may cause inaccurate results.
- plasma that has been congealed may, on thawing, contain sediments that must be removed
before any measurement is performed.
Pre-analytic conditions regarding products and reagents: the laboratory must strictly
comply with the instructions provided by the manufacturer in the inserts of the products and
reagents. Poor preparation of the reagent as regards reconstitution volume, stabilization time,
stirring, the presence of bubbles, forgetting or inappropriately leaving in a magnetic stir bar may
lead to incorrect results.
The ISI value of the thromboplastin used for the determination of the prothrombin time should
be the one indicated on the assay value insert. Any change in lot, any software update - like any
intervention - should give rise to verification of the ISI value.
Configuration and condition of the analyzer: the laboratory must take care that the test
configuration complies with the manufacturers prescriptions for reagents, in particular for the
volumes used, the incubation times, the rinsing solutions, the buffers, etc. It is the laboratory's
responsibility to correctly enter the bar codes and to choose the appropriate test configuration
for a given test. The laboratory must make sure that the analyzer is regularly maintained,
according to the recommendations given in this manual.
In addition, the analyzer gives results from biological material and although this material is used
and measured by highly sophisticated computer-controlled automated systems in order to
optimize the reliability and security, it is impossible to guarantee an error rate of zero.
For example, studies carried out on the prothrombin rate have demonstrated that when the preanalytic conditions are respected, the inconsistency rate (difference between two results
> 15 %) on duplicate tests is less than one in ten thousand. This rate may be compared with the
1-3
0931634 - October 2007
REFERENCE MANUAL
error rate likely to be observed for tests in single determination. It should be noted that below
one in ten thousand, it is difficult to qualify an error rate experimentally and precisely. This
inconsistency rate is given as an indication ; it may vary according to the test/assay, sample volume,
dilution...
This data indicates that if duplicate tests are carried out on the same sample, the error rate is
mathematically of the order of one in one hundred million, which although not zero can be
considered as negligible.
Lastly, the results produced by the analyzer must always be analyzed according to the patients
history, the clinical examination and any other biological results.
-
Conditions regarding the validation of methods and techniques: the test configurations
provided by Diagnostica Stago have been validated individually for the
STA-R Evolution analyzer and the possible interactions between the reagents have also been
evaluated. Each laboratory must, considering the regulations applicable in each country, the
specificities and the population of the laboratory patients and the nature of each test, select and
validate the test method used. If the laboratory decides to use other lines of reagents and
methodologies that have not been validated by Diagnostica Stago as useable with the STA-R
Evolution analyzer, a validation of this new system will be necessary. This validation will ensure
that the characteristics of the method are verified on the one hand (see references, 2nd
reference) and that any possible interactions between the new and the old products are checked
on the other hand.
1.5 Bibliography - Warnings

-
KOEPKE J. A., McLAREN C. E., WIJETUNGA A. AND HOUWEN B.:

"A Method To Examine the Need for Duplicate Testing of Common Coagulation Tests".
Am. J. Clin. Pathol., 102, 2, 242-246, 1994.
VASSAULT A. et al.:
"Protocole de validation de techniques" (Protocol for validation of techniques).
Ann. Biol. Clin., 44, 686 - 745, 1985.
1.6 Warnings regarding the use of access security

The various functions of STA-R Evolution may be classed into 2 levels:
-
Routine functions (example: launching analyses, loading products),
Modification functions (example: creation or modification of test configurations).
For all these functions, security levels can be defined.

The use of routine functions has no incidence on the results obtained. On the other hand, the use of
modification functions may have consequences on the reliability of the results.
For this reason, it is mandatory for each laboratory to evaluate the consequences of using various
functions before assigning security access.
1-4
0931634 - October 2007
REFERENCE MANUAL
1.7 Warnings regarding the STA-R Evolution system

Contextual help is a service provided by the software installed on the STA-R Evolution, protected
by Diagnostica Stago copyrights that facilitate use of STA-R Evolution. Nonetheless, to ensure the
security and efficacy of the STA-R Evolution system, it is absolutely necessary for the user to be
familiarized with all warnings, procedures, recommendations contained in the Reference Manual in
the latest updated version.
The STA-R Evolution may only be installed by a technician duly authorized either by Diagnostica
Stago or by one of its official distributors.
To avoid any risk of electrical shock, it is absolutely necessary to follow the procedures described in
this documentation precisely (STA-R Evolution online help or reference manual).
The STA-R Evolutionwas made and tested according to the CISPR 11 (International Special
Commitee On Radio Interference) for class A equipment. In a domestic environment, it may cause
radio interferences, in which case, measures will have to be taken to reduce these interferences.
The analyzer conforms to the EN 61326-2-6-2006 standard.
The electromagnetic environment should be evaluated before using the analyzer.
Keep away from the analyzer all sources of high electromagnetic radiation (cellular phones,
unprotected sources of radio frequency...) as they may interfere with the operating conditions of the
analyzer.
For security reasons, the front panel of STA-R Evolution and the access cover to the rack conveyor
should be kept closed. If these parts are open, the STA-R Evolution will detect their absence and
will immediately stop the analyses in progress. Do not attempt to defeat the operation of the
switches that detect the presence of the front panel and the rack conveyor access cover.
It is absolutely necessary to check that all covers, covers and drawers of the STA-R Evolution (listed
below) are closed before power is turned on. During operation, it is absolutely necessary to close
them as soon as any handling requiring them to be opened is finished.
-
upper left side cover
lower left side cover
upper right side cover
lower right side cover
front cover
access cover for the tube turning wheel
transparent cover
products drawer
If it is necessary to come near the analyzer to observe the stage in tube loading inside the analyzer
or the progress of an analysis, make sure that you wear disposable gloves, goggles and a face mask.
For security reasons, the operator should completely close the front panel of the STA-R Evolution
himself/herself.
To prevent damage to the monitor touch screen panel, do not use any sharp object to point to an
element on the screen.
The expiry dates and lot numbers of the following products are not controlled by the analyzer:
-
STA-OWREN KOLLER dilution buffer,
1-5
0931634 - October 2007

-
STA-Desorb U solution,
STA-CaCl2 reagent.
REFERENCE MANUAL
Therefore, the user must check the expiry date of these products before loading them in the
analyzer.
For these products, only the stability and the volume are controlled by the analyzer.
The stability of the reagents which were unloaded and then reloaded is not controlled by the analyzer
and remains on the entire responsibility of the user.
1.8 Warning regarding the analyzer disposal

Waste Electrical and Electronic Equipment (WEEE).
The use of this symbol implies that the analyzer must not be disposed of with
household waste; that it must be subject to separate collection and that it has been put
on the market after 13 August 2005.
For more information about the appropriate disposal of the analyzer (in countries other than France),
contact the local distributor.
1-6
0931634 - October 2007
REFERENCE MANUAL
Content
Introduction
2.1
Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
2.1.1
Installation requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
2.1.2
Installation procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
2.1.3
Setting date and time . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
2.1.4
Connecting peripheral devices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
2.2
Presentation of the analyzer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
2.2.1
Purpose of the analyzer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
2.2.2
General description of the analyzer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
2.2.3
Description of the measuring system in chronometry . . . . . . . . . . . . . . . . . . 6
2.2.4
Description of the measuring system in photometry . . . . . . . . . . . . . . . . . . . 7
2.2.5
Description of steps in analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
2.2.6
Description of sample loading . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
2.2.7
Description of product loading . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
2.2.8
Description of the incubation block-measurement . . . . . . . . . . . . . . . . . . . 11
2.2.9
Description of the cuvette movement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
2.2.10
Description of the distribution of plasmas and products . . . . . . . . . . . . . . . 12
2.3
Technical specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
2.3.1
2.3.2
2.3.3
2.3.4
.............................................. 1
1
0931634 - October 2007
Content
REFERENCE MANUAL
2
0931634 - October 2007
REFERENCE MANUAL
Introduction
2 Introduction
2.1 Installation
2.1.1 Installation requirements
Space to be reserved for the system
-
Height: 1875mm (73,8 in.).
Width: 2940mm (115,7 in..).
Depth: 1300mm (51,2 in.).
Electrical power supply

-
Voltage and tolerances: 230V (10%), 210V (10%), 115V (10%), 100V (10%).
Frequency and tolerance: 50/60Hz.
Power: 2kW.
2.1.2 Installation procedure

The STA-R Evolution may only be installed by a representative duly authorized either by
Diagnostica Stago or by one of its official distributors. Likewise, if the STA-R Evolution needs to be
moved, this must be done by a representative of Diagnostica Stago, or by one its official distributors
who has the equipment necessary to handle the analyzer.
2.1.3 Setting date and time

" From the desktop, right click the clock located on the task bar in the corner of the screen then
click Adjust date/time.
The Date/Time Properties dialog box appears.
" Click the Time Zone tab.
2-1
0931634 - October 2007
Introduction
REFERENCE MANUAL
" From the pull-down menu (mark 1 in the figure above), select the required geographical zone.
" Select "Automatically adjust clock for daylight saving changes" (mark 2).
" Click the Date & Time tab.
" Select the month (mark 1), the year (mark 2) and the hour (mark 3).
" Click
2.1.4 Connecting peripheral devices

The various external peripheral devices are connected to the back and the bottom of the analyzer.
2-2
0931634 - October 2007
REFERENCE MANUAL
Introduction
Turn the STA-R Evolution off before connecting:

- the screen,
-
the printer,
the serial port used to connect a modem,
the Touchpad: tactile keyboard pad,
the tactile part of the screen,
the keyboard,
the serial port used to connect to the server.
2-3
0931634 - October 2007
Introduction
REFERENCE MANUAL
Representation of external connections.

Connection for:
Mark
Element to be connected
VGA tactile 15" minimum screen
Parallel port for printer

Do not remove the element (dungle)
connected to the port. Connect the printer to the dungle.
Serial port (modem connection)
"Touchpad": tactile keyboard pad
Tactile part of the screen
Keyboard
Serial port
(connection to server)
USB ports
Pictogram
2.2 Presentation of the analyzer

2.2.1 Purpose of the analyzer
The STA-R Evolution system is a piece of medical equipment for in vitro diagnostic use that
comprises a laboratory analyzer and software designed to be used together with consumables and
reagent products. The STA-R Evolution system has been designed to perform in vitro tests for
diagnosis and monitoring of pathologies related to hemostasis.
2-4
0931634 - October 2007
REFERENCE MANUAL
Introduction
It is possible to perform chronometric tests (measurement of coagulation time), colorimetric tests

or immunological tests on plasma samples.
2.2.2 General description of the analyzer
Upper left side door:

Syringes for arms 1, 2 and 3 (see chap. 4.5.1 of this manual)
Rack panel / loading zone:

- Loading a Stat rack (see chap. 3.6.7 of this manual)
Access cover to the tube rotating wheel

- Bar code scanner for samples (see chap. 3.6.2 of this manual)
- Tube rotating wheel (see chap. 4.7.4 of this manual)
Lower left side door

- Diskette drive
- CD/DVD recorder
- Data backup and exportation (see chap. 4.10.2 of this manual)
- Changing secondary fuses (see chap. 4.8.5 of this manual)
Main air filter
Transparent cover
- Cleaning needles 1, 2 and 3 (see chap. 4.4.2 of this manual)
- Cleaning the rinsing well (see chap. 4.4.2 of this manual)
- Cleaning the measurement plate (see chap. 4.4.7 of this manual)
- Cleaning the suction tip (see chap. 4.4.8 of this manual)
- Cleaning the shuttles (see chap. 4.4.10 of this manual)
2-5
0931634 - October 2007
Introduction
REFERENCE MANUAL
Upper right side door

- Loading the cuvette reel (see chap. 3.3.1 of this manual)
- Cleaning the conveyor belt (shuttle transporter) (see chap. 4.4.9 of this manual)
- Changing the grip filter (see chap. 6.5.4 of this manual)
- Condensation trap (see chap. 4.3.1 of this manual)
- Cuvette loader (see chap. 4.7.3 of this manual)
Product bar code reader

- Reading bar code labels for products (see chap. 3.4.3 of this manual)
Products drawer
10 Front door
- Loading of cleaning solution (see chap. 3.3.3 of this manual)
- Changing liquid waste bottle
- Loading the cuvette waste bin (see chap. 3.3.2 of this manual)
11 Lower right side door

- Optic Module Halogen lamp (see chap. 4.8.3 of this manual)
- Optic Module air filter (see chap. 4.6.1 of this manual)
- On/off switch (see chap. 3.2.1 of this manual)
- Main fuses (see chap. 4.8.4 of this manual)
2.2.3 Description of the measuring system in chronometry

The principle consists of measuring the variation in amplitude of the balls oscillation. A reduction in
amplitude corresponds to an increase in the mediums viscosity, in other words, in the coagulation
phenomenon.
At constant viscosity, you obtain a constant pendulum-like swinging movement of the ball thanks to
two rails curving inwards on the bottom of the cuvette and in the electromagnetic field created
alternatively on each side of the measuring head to maintain this swinging movement. The frequency
of this field is close to the proper frequency of the balls oscillation, which ensures a good level of
sensitivity in the system.
For each measurement head, the magnetic field is created by two motor coils and automatically
adjusted by the software as a function of the mediums viscosity and of the type of clot being tested
for (weak clot for Fibrinogen, normal clot for all the others).
The measurement heads include an emitting coil and a receiving coil.
2-6
0931634 - October 2007
REFERENCE MANUAL
Receiver coil
Transmitting coil
Drive coil
Ball
Cuvette
Introduction
At constant viscosity, the amplitude of the balls oscillation is constant. When the viscosity increases
(the phenomenon of coagulation), the amplitude of the balls oscillation decreases. An algorithm uses
this variation in amplitude to determine coagulation time.
2.2.4 Description of the measuring system in photometry

The detection principle in the colorimetric or immunological tests on STA-R Evolution is based on
the absorbance (optical density, O.D.) of monochromatic light (405 nm or 540 nm) passing through
a cuvette at the time when a chromogenic reaction takes place.
The principle behind measurement of absorbance is presented in the figure below. Incident light (I0)
that penetrates the cuvette is partly absorbed by the reagent medium.
Transmitted light (I1 = I0 +Ip) is measured and converted into absorbance by the following equation:
A = Log (I1/I0)
Note: Decimal logarithm
2-7
0931634 - October 2007
Introduction
REFERENCE MANUAL
Ambient light (Ip) is eliminated by taking 2 measurements of transmitted light within a brief interval:
I1 = I0 + Ip (first measurement with incident and ambient light),
I2 = Ip (second measurement by blocking incident light, corresponds to ambient light).
Then by subtracting I2 from I1, we obtain I0 that corresponds to light resulting only from incident
light. We suppose that ambient light (Ip) remains identical between 2 measurements.
The source of monochromatic incident light (I0) is obtained from a tungsten halogen lamp and from
a filter (405 nm or 540 nm) placed in a moveable filter holder.
These various parts are found in the optic module. From the optic module, the monochromatic light
is directed to the measurement heads by fiber optics, then from the measurement heads to the
analog measurement card through other fiber optics, see figure below.
I0 (incident light) is known thanks to the reference fiber (the fiber that goes directly from the optic
module to the analog measurement card).
2-8
0931634 - October 2007
REFERENCE MANUAL
Introduction
Measurement head
RS232
Reference fiber
PC
Sensor
9-Optical fiber harness
Analog measurement board
Photometry module with switch-over

filters
CPU measurement board
From the measurements of optical density that are obtained, the Beer-Lambert law is applied, that is:
A = IC
where:
A
absorbance
coefficient of molecular extinction
length of the optical trajectory
concentration
The concentration of the chromogen sought is directly proportional to absorbance.

Note: All measurements of optical density are done in relation to the reference fiber.
2.2.5 Description of steps in analysis

The plasma (sample, control or calibrator) is pipetted by needle n1 with or without diluting agent
then distributed in a cuvette (shuttle with cuvette is stopped at the sample stop).
If intermediate reagents are required, the feed is stopped at the reagent stop and these are added to
the cuvette by needle n2. The shuttle is then stopped at the measurement stop for the arm equipped
with suction cups to transfer the cuvette to the incubation zone.
A few seconds before the incubation time elapses, the cuvette is moved to the measuring area by the
arm with the suction cups. The reagents to be distributed after the first incubation (principally the
start reagent) are pipetted by needle n3. When preheating the reagents to 37C is required, the
reagents are maintained for about 2 seconds in needle n3's heating tube. Then, with or without
preheating, the reagents are distributed in the corresponding cuvette in the measuring area. As soon
as measuring is finished, the suction cup arm takes the cuvette and disposes it in the cuvette waste
bin.
2.2.6 Description of sample loading

The primary tubes are loaded onto racks of 5 tubes after centrifugation. They are then put into a tray.
This is put into the loading/unloading area of the STA-R Evolution.
2-9
0931634 - October 2007
Introduction
REFERENCE MANUAL
The STA-R Evolutions software detects the presence of the basket of racks and proceeds to load
its contents. Each rack moves in front of the sample bar code reader.
The bar code label identifying the rack is read. A wheel then rotates the tubes in front of the bar code
scanner until the label is scanned. Available only if you use Diagnostica Stago racks and the Stago
reading mode.
Thanks to the scanning of the rack and tube identifications, the system is able to know the location
of any tube in the analyzer. The racks then move into the pipetting area.
There is an area where the samples can be pipetted immediately (zone A with 28 racks) and a storage
area where the samples can not be directly pipetted.
2-10
0931634 - October 2007
REFERENCE MANUAL
Introduction
2.2.7 Description of product loading

All products required to carry out analysis are to be loaded into the product drawer. An area is
reserved for each type of product.
Area
Type of products
Blue (Left)
(R0)
Calibrators,
Controls,
Diluents,
White (Center)
(R1)
Blue (Right)
(R2)
Reagents to be distributed after the first incubation (mainly start

reagents)
In the center and right areas, some positions are equipped with a stirring motor for use with a
magnetic stir bar.
These are identified by the symbol
Before loading, each product vial is identified (bar code label reader). The vials are then loaded, their
position is automatically recognized by the Positive Identification system.
The temperature of the products is maintained between + 15C and + 19C by an air conditioning
system (circulation of cool air).
2.2.8 Description of the incubation block-measurement

The incubation area and the measurement area are part of the same block, which is maintained at
37C 0.5C by a system based on a laminar resistor.
2.2.9 Description of the cuvette movement

The reaction/measurement cuvettes are loaded on to the STA-R Evolution in the form of a reel of
1000 cuvettes. They are distributed one by one into cuvette shuttles by a double belt conveyor. On
the conveyor belt, the cuvette shuttles can be immobilized at stop stations for distribution of plasma
or reagents, to be transferred to an incubation area or for shuttle loading.
2-11
0931634 - October 2007
Introduction
REFERENCE MANUAL
2.2.10 Description of the distribution of plasmas and products

A needle is reserved for each type of product.
Needle
Products
N1
Sample plasmas (racks of 5 tubes)
Control plasmas and calibrator plasmas (left part of the products drawer)
N2
Reagents to be distributed before the first incubation (central area in the

product drawer)
N3
Reagents to be distributed before the first incubation (right part of the

product drawer)
A system to detect the level of liquid is associated with each needle.

Between each distribution/sampling, each needle is rinsed inside and outside in its rinsing well, which
eliminates possible contamination.
2.3 Technical specifications

STA-R Evolution system is exclusively made of the instrument, its screen and its keyboard and
must be used inside.
Type:
-
In vitro diagnosis analyzer
Multi-parameter analyzer
Functions patient by patient
Conditions of use:
-
Temperature: +15C at +32C (59F to 89.5F).
Humidity: 20 to 80%.
Altitude: <2000 m.
Intensity of incident light on the open drawer.
Storage and transport:

-
Shock resistance: according to the norms in force.
2-12
0931634 - October 2007
REFERENCE MANUAL
Temperature: -20C at +60C (-4F to +140F).
Relative humidity: 20 to 80%.
Dimensions of the crated analyzer:

Height: 1,460 mm
Width: 1,460 mm
Depth: 960 mm
Weight of the crated analyzer: 374 kg
Non stackable storage.
Introduction
Environment:
-
Maximum volume level: 55 dB.
Heat generated at an ambient temperature of 20C:

Dimensions of the analyzer:

-
Height: 1250mm (49,2 in.).
Width: 1280mm (50,3 in.).
Depth: 820mm (32,3 in.).
Weight of the analyzer:

-
256kg (564 lb)
Space to be reserved for the system:

-
Height: 1875mm (73,8 in.).
Width: 2940mm (115,7 in.).
Depth: 1300mm (51,1 in.).
Electrical power supply:

-
Voltage: and tolerances: 230V ~ (10%), 210V ~ (10%), 115V ~ (10%), 100V ~ (10%).
Frequency: and tolerance: 50/60Hz (47 to 65Hz).
Power:
- 2kW (for 210 V ~ / 230 ~)
- 1.8 kW (for 100 V ~ / 115 V ~)
- maximum 2.5 kW (peak value)
Number of outlets: 3 (1 for the STA-R Evolution, 1 for the screen and 1 for the printer): 1 earth
and 2 poles, 16 A
Protection fuses: yes.
Need of surge protection for micro-cuts: no.
Effects of a distinct cut-off: lost tests in progress, possibility of change in hard disk.
Possible extensions:
-
Cap piercing option
Line Automation connection option

Standards:
2-13
0931634 - October 2007
Introduction
REFERENCE MANUAL

- EN 61326-2-6 (Class A for emissions and industrial immunity)
- EN 61010-1 and EN 61010-2-101

- UL marking
- FCC Part 15
- UL 61010 A-1 (Underwriters laboratory)

- CEI 61326 (Class A for emissions and industrial immunity)
- CEI 61010-1 and CEI 61010-2-101
Classification:
-
Type of protection against electrical shock: Class I device
Degree of protections against water penetration: ordinary device (device under wrap without
protection against water penetration).
Degree of protection against electrical shock: Type B device.
Degree of security of use: device not adapted for use in the presence of a flammable anesthetic
mixture with air, oxygen or nitrogen protoxide.
Degree of pollution: 2
Recommended disinfection method: see procedure in chapter 4.9.1 of this manual.
Mode of operation: continuous service.
Note: All devices connected to the STA-R Evolution should comply with the CEI 60950 and/or EN
55022 class B norms.

Sample management:
-
Primary centrifuged tubes with or without bar code (uncapped tubes) with:
- 11mm (0.43 in.) diameter for a 3ml tube,
- 11.6 to 13.4mm (0.46 to 0.53 in.) diameter for a 5ml tube,
- length of 65 to100mm (2.56 to 3.94 in.).
BD Vacutainer pediatric tubes 10 mm diameter and 47 mm or 64 mm high.
List of recommended tubes for capped tubes, see the list in the 0931208x document "Cap
piercing option: list of tubes".
Rack of 5 tubes.
Tray of 15 racks.
Capacity of 43 racks in the analyzer: 28 in pipette ready position right away and 15 in the storage
area.
Positive Identification and bar code reader.
Automatic dilutions.
Product management:
2-14
0931634 - October 2007
REFERENCE MANUAL
Introduction
1 drawer divided into 3 areas:

R0:1 area for controls, calibrators and diluting agents,
R1: 1 area for reagents to be distributed before the first incubation,
R2:1 area for reagents to be distributed after the first incubation,
2-15
0931634 - October 2007
REFERENCE MANUAL
Introduction
R0 Area:
Previous version
Current version
positions for 4ml vials ( 18.6 mm)
18
16
No stirring positions
R1 Area:
Previous version
Current version

stirrers
11
10

stirrers
15
15
Previous version
Current version

stirrers
12
10

stirrers
R2 Area:
Identification by bar code reader
Air conditioned zone (15C to 19C)
Management of the stability and the volume of the products
Note: Products = controls, calibrators, reagents, diluents, decontaminating solution.

Bar code reader:
-
Maximum peak power: 4.6 mW
Pulse of 1 ms at 100 Hz
Standard CEI 60825-1: Class 1M
2-16
0931634 - October 2007
REFERENCE MANUAL
Introduction
Measurement principle:
-
Modes of analysis: chronometry and photometry.
Chronometry: modification in viscosity of the medium, detection by electromagnetic sensors.
Photometry: measurement of optical density to 405nm and to 540nm.

- colorimetry
- turbidimetry (immunology)
Pipettors:
-
3 250l syringes.
Cuvettes:
-
In the form of rolls of 1000 cuvettes with integrated stainless steel balls.
Management of the roll tracking: identification by bar code.
Authorizing a pendulum movement of the ball (STAGO patent).

Patent N:
- FR 8718348
- FR 8809151
- US 4918984
- JP 1939942
- EP 0325874
Maximum useable volume: 400l.
Minimum volume: 150l in chronometry and 250l in photometry.
Performance:
-
Intra-trial repeatability using Diagnostica STAGO products
Normal plasmas
PT (sec)
< 1,5 %
<2%
APTT (sec)
< 1,5 %
<2%
Fib. (sec)
<4%
<5%
Inter-sample repeatability using Diagnostica STAGO products:
Normal plasmas
PT (sec)
<3%
<3%
APTT (sec)
<3%
<3%
Fib. (sec)
<4%
<5%
2-17
0931634 - October 2007
Introduction
REFERENCE MANUAL

PC integrated (minimum characteristics):
-
Microprocessor: Pentium MMX (200MHz minimum)
Random Access Memory: 64Mb
Hard disk: evolving (2.4Gb Min.)
Diskettes: 1,44Mb
CD/DVD recorder
Writable disks: CD-R, CD-RW, DVD
9 micro-controlers
Operating system: Windows XP
Computer connection:
-
ASTM protocol
Output from STA-R Evolution, SUB-D 9 connecting pins
Screen:
-
CRT = VGA color minimum 15 tactile (resistant) ferrite on power supply cable
or TFT = 17 with tactile surface
Keyboard:
-
Alphanumeric with pointer keys
2-18
0931634 - October 2007
REFERENCE MANUAL
Content
Routine use
3.1
Meaning of icons and symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
3.1.1
Meaning of symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
3.1.2
Meaning of the icons . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
3.2
Analyzer preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
3.2.1
Turning the analyzer on . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
3.3
Loading/unloading consumables . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
3.3.1
Change the cuvette roll using bar code identification . . . . . . . . . . . . . . . . . . 8
3.3.2
Change the cuvette disposal bag . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
3.3.3
Loading the cleaner solution . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
3.4
Loading/unloading the products . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
3.4.1
Warnings related to loading products . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
3.4.2
Open the Products drawer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
3.4.3
Loading a product with bar code identification . . . . . . . . . . . . . . . . . . . . . . 16
3.4.4
Loading a product using manual identification . . . . . . . . . . . . . . . . . . . . . . . 18
3.4.5
Loading a product without positive identification of the positions . . . . . . . . 19
3.4.6
Unloading the products using positive identification . . . . . . . . . . . . . . . . . . 20
3.4.7
Unloading the products without positive identification . . . . . . . . . . . . . . . . 20
3.4.8
Close the Products drawer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
3.4.9
Enter the bar code information manually . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
3.4.10
Sorting products - Product list screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
3.4.11
Sorting products Forcecast Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
3.5
Quality control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
3.5.1
Running a quality control manually . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
3.5.2
Validating a quality control result . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
3.5.3
Deleting a quality control result . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
3.5.4
Display the days controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
............................................... 1
1
0931634 - October 2007
Content
REFERENCE MANUAL
3.5.5
Displaying the last quality control result . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
3.5.6
Printing the days controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
3.5.7
Displaying and printing the quality controls for a given period . . . . . . . . . . 28
3.5.8
Printing a quality control in graphical mode . . . . . . . . . . . . . . . . . . . . . . . . . 29
3.5.9
Changing the values of the thresholds for a quality control . . . . . . . . . . . . . 31
3.5.10
Transmitting a control result . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
3.5.11
Deleting all quality control results for a level . . . . . . . . . . . . . . . . . . . . . . . . 31
3.6
Loading/unloading the samples . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
3.6.1
Loading a Patient tube . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
3.6.2
3.6.3
3.6.4
3.6.5
3.6.6
Loading a rack of tubes / manual identification mode Case n5 . . . . . . . . 38
3.6.7
Urgent (STAT) loading of a rack of tubes / manual identification mode Case n6

40
3.6.8
Urgent (STAT) loading of a rack of tubes / automatic identification mode Case n7

41
3.6.9
Tagging racks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
3.6.10
Tagging all racks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
3.6.11
Removing the tag from all the racks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
3.6.12
Removing the tag from some racks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
3.6.13
Sorting the racks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
3.6.14
Printing the list of racks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44
3.6.15
Unloading a rack . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44
3.6.16
Unloading several racks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45
3.6.17
Unloading all the racks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45
3.6.18
Reloading a rack after the unloading of a tube . . . . . . . . . . . . . . . . . . . . . . . 46
3.6.19
Release the tray . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
3.7
Processing patient files . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48
3.7.1
Tagging patient files . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48
3.7.2
Adding a test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50
2
0931634 - October 2007
REFERENCE MANUAL
Content
3.7.3
Blocking/unblocking tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53
3.7.4
Rerunning a test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56
3.7.5
Deleting a test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57
3.7.6
Validating the results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59
3.7.7
Viewing a result . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61
3.7.8
Transmitting results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62
3.7.9
Moving a sample that has already been loaded to STAT sample . . . . . . . . . 65
3.7.10
Looking for a patient file . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65
3.7.11
Printing patient files . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 66
3.7.12
Changing the display of the test panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68
3.7.13
Adding a note to a patient file . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 70
3.8
Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 70
3.8.1
Running a calibration Calibration screen . . . . . . . . . . . . . . . . . . . . . . . . . . 70
3.8.2
Automatic calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 71
3.8.3
Changing a calibration point . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 73
3.8.4
Changing the100% point . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 74
3.8.5
Rerunning a calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 74
3.8.6
Rerunning a calibration point . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 74
3.8.7
Resuming an initial calibration point . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75
3.8.8
Resuming an initial calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75
3.8.9
Resuming the initial 100% point . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 76
3.8.10
Entering or changing the ISI and/or the reference time . . . . . . . . . . . . . . . . 76
3.8.11
Deleting a calibration point . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 76
3.8.12
Deleting a calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77
3.8.13
Validating a calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77
3.8.14
Canceling a calibration in progress . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 78
3.8.15
Printing a calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 78
3.9
Archives . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 78
3.9.1
Deleting patient files - Archives Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79
3.9.2
Sorting patient files - Archives Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79
3
0931634 - October 2007
Content
REFERENCE MANUAL
3.10
Test setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79
3.10.1
Creating a test setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79
3.10.2
Copying a test setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 80
3.10.3
Creating a dependent test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 80
3.10.4
Creating a calculated test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81
3.10.5
Changing a test setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 82
3.10.6
Updating a test setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 82
3.10.7
Updating several test setups . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 83
3.10.8
Deleting a test setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 84
3.11
Shutting down STA-R Evolution . . . . . . . . . . . . . . . . . . . . . . . . . . . . 84
3.11.1
Routine shut down . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 84
3.11.2
Prolonged shut down . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 86
4
0931634 - October 2007
REFERENCE MANUAL
Routine use
3 Routine use
3.1 Meaning of icons and symbols
3.1.1 Meaning of symbols
Patient file
Rack
Product
Calibration
Quality
control
Useable
1st calibration
validated
Validated
Empty task list
2nd calibration
validated
At least one test
in progress
At least one
tube with tests
in progress
Product due to
expire (on
board volume
<20% and/or
close to the
end of stability
time / length of
use)
1st calibration
in progress
In progress
2nd calibration
in progress
At least one test
to be validated
1st calibration
to be validated
To be
validated
2nd calibration
to be validated
At least one test
in error
Unuseable
1st calibration
not performed
or erroneous
Not
performed or
erroneous
2nd calibration
erroneous
Validated
3-1
0931634 - October 2007
REFERENCE MANUAL
Routine use
Patient file
Rack
Product
Calibration
Quality
control
Download
request carried
out for this file
Patient file
transmitted
Patient file
identified
manually or reidentified
Patient file
printed
Stat
Sample loaded
into a pediatric
microcontainer or
tube
Stat with
sample tube
loaded into a
pediatric microcontainer or
tube
Corresponds to
a calibrator
Corresponds to
a quality control
One or more
alarms are
associated with
the result
Patient file
printed (or to
be printed)
3-2
0931634 - October 2007
REFERENCE MANUAL
Routine use
3.1.2 Meaning of the icons
Function panel
Display the screen for right-handed
or left-handed users
Display the Patient menu
Display the Products menu
Display the Calibration menu
Display the Quality Control menu
Display the Setup menu
Display the contextual help
Display the Stat menu
Display the Maintenance menu
Control panel
Display the Archives menu
Display the Search menu
Suspend sampling
Resume sampling
Suspend transmission
Resume transmission
Load in normal mode
Automatically unload the unread

tubes
Load in manual mode
Load a rack
Load all racks
Tag files or Untag files
System panel

3-3
0931634 - October 2007
Routine use
REFERENCE MANUAL
When flashing, a test is blocked due

to lack of product (reagent, control
or calibrator)

blocked (insufficient Desorb,
manual blocking of samples etc.)

blocked because of lack of
calibration
When flashing, the photometric

tests are blocked because of an
error detected in the photometry
circuit
Restart the analyzer
Emergency shutdown
Exit system
Run printing
Display the analyzer control

screen
Status of the tests

cuvette
Distribution of the intermediate

reagent(s)
Distribution of the releasing

reagent
progress
Colorimetric measurement in
progress (405 nm)
progress (540 nm)

product
Test requested for a patient file with

sample tube waiting to be loaded
(not on board)
Patient file
Set the patient file in normal mode
Set the file in stat mode
Transmitting a patient file
Validating the file
Display detailed description of the

alarm(s) associated with the results
Display the result main board
3-4
0931634 - October 2007
REFERENCE MANUAL
Routine use
Products
Load a cuvette roll
Load an STA-Cleaner Solution

bottle
Product requiring stirring by the

magnetic stirring device
Product contained in a microcup
Test rerun, for example after a

technical error (missing ball etc.) or
because of detection of a time
period less than the min. time
(<Vmin) or greater than the max.
time (>Vmax)
Test started again because of a

problem in detection of level
Results
V>
Vmax

measurement greater than the
max. time defined in the test setup,
or if the linear extrapolation is
greater than the max. time in the
calibration.
V<
Vmin

measurement less than the min.
time defined in the test setup, or if
the linear extrapolation is
less than the min. time in the
calibration.
Error
Technical error
Lin.
Insufficient linearity for the

colorimetric or immunological tests
QNS
Quantity of plasma not sufficient
File completion
Modify a file
Add a file
Creation of a test profile
Quality control
Run a quality control manually
Change the result acceptance range
Delete a quality control result
Validate a quality control result
Delete all quality control results for

the level selected
Display the last quality control

result
3-5
0931634 - October 2007
Routine use
REFERENCE MANUAL
Transmit a control point
Display the days quality controls
Control missing for product drawer
Display the comments associated

with a quality control
Calibration
Display the 1st calibration
Display the 2nd calibration
Calibrator missing for product

drawer
Status of the racks
Rack that has been unloaded and

that is inside the tray
File present but tube is not loaded
Unloading / Reloading
Unload the tagged racks
Reload the racks located on the tray
Release the tray
3.2 Analyzer preparation

3.2.1 Turning the analyzer on
The STA-R Evolution is designed to operate 24 Hours by following the maintenance procedure
described in chapter 4 of this manual.
" Ensure that all the covers, doors and the product drawer of the STA-R Evolution are shut/closed
properly.
" Turn the printer power switch on.
" Turn the power switch of the STA-R Evolution to the On (I) position.
This switch is located on the bottom right side of the STA-R Evolution.
" Turn the monitor power switch on.
" Double click the icon
3-6
0931634 - October 2007
REFERENCE MANUAL
Routine use
time (the check is displayed on the screen)
The software initialization window is displayed:
" Click the icon
to initialize the main software application faster.
The following message may be displayed:

"Rack Conveyor Initialization
Do you want to initialize the rack conveyor?": click
and tubes on the conveyor to be re-identified, or
if you want all the racks

to avoid the conveyor being initialized.

"If you are sure that no sample was moved
press Yes to cancel the Init.", click
Note: If one or more products are missing, the
to confirm or if not, click
icon flashes for 15 seconds. An alarm will
sound at the same time. The list of missing products will be displayed when you click the
icon.
The STA-R Evolution is ready to be used.

Note: If an error message about temperature is displayed, wait 5 minutes for the temperature to
stabilize then close the message by clicking the
icon.
3-7
0931634 - October 2007
Routine use
REFERENCE MANUAL
3.3 Loading/unloading consumables

3.3.1 Change the cuvette roll using bar code identification
The reagent cuvettes are disposable consumables. Diagnostica Stago cannot be liable for any
damages whatever, direct, indirect, material or immaterial if washed and/or reused cuvettes and/or
cuvettes other than those manufactured and distributed by Diagnostica Stago or distributed by its
official distributors are used.
Keep the plastic bag which contains the new cuvette roll to use it as a new disposal bag for the
cuvette bin.
Keep the cut off part of the plastic bag (see instruction on the bag) to use it as a link to close the
disposal bag (see procedure in chapter 3.3.2 of this manual).
Note: The bar code tracking option is now active for the cuvette rolls.
When the quantity of cuvettes has depleted, the following window appears:
" Click
3-8
0931634 - October 2007
REFERENCE MANUAL
Routine use

" Lift the cuvette take up reel maintenance handle.
" Remove the cuvette take up reel by sliding it off the axle shaft.
" Open the door/flap to the cuvette loader.
The motor that powers the cuvette take up reel may turn.
" Lift the maintenance handle for the cuvette roll.

" Remove the cuvette roll by sliding off the axle shaft.
" Dispose of the cuvette roll and its cuvette take up reel.
Note: The new cuvette rolls are all supplied with a new cuvette take up reel.
" Take the new cuvette roll and cut along the dotted line. Keep both the plastic bag and the upper
part of the bag that has just been cut off. The former will be used as a new disposal bag for the
cuvettes bin, whereas the latter will be used as a link to tie up the used disposal bag (see
instructions on the plastic bag).
" When reading the cuvette roll bar code data, hold the bar code of the new cuvette roll in front
of the product drawer bar code reader. If these 2 bar code labels are not detected by the reader,
the information from both bar code labels can be typed manually.
" Click
showing the number of cuvettes and the code/batch of the roll that has just been loaded.
" Hold the new cuvette roll with the roll in your left hand and the cuvette take up reel in your right
hand.
3-9
0931634 - October 2007
Routine use
REFERENCE MANUAL
" Slide the new cuvette roll onto the axle shaft and lower the rolls maintenance handle.
" Slide the cuvette take up reel onto the axle shaft and lower the cuvette take up reels maintenance
handle.
" Put the film into the cuvette loader so that it is parallel to the loading rails, then close the cuvette
loader door/flap.
- Do not twist the film.

- Do not turn the cuvette take up reel by hand. Use the feed button (2) to move the take up reel
and advance the cuvette film..
" Press the feed button (2) to start feeding the cuvettes.
Cuvette take up reel
Cuvette feed button
Cuvette loader door/flap
" Ensure that the cuvettes enter the cuvette loader without twisting sideways. Keep pressing the
feed button until the cuvettes have been completely inserted into the loader.
" Close the upper right side door.
" Click
3-10
0931634 - October 2007
REFERENCE MANUAL
Routine use
" Proceed with changing the cuvette disposal bag (see procedure in chapter 3.3.2 of this manual).
Note: The software will allow you to load a new cuvette roll before the current cuvette roll is
completely empty:
" Directly access the changing cuvette rolls menu by clicking the
icon from the Products
screen. Follow the same procedure described in this chapter.
The previous cuvette rolls information will be saved (i.e.: quantity of cuvettes remaining at the
time of roll removal). This information will be restored when the cuvette roll is reloaded.
3.3.2 Change the cuvette disposal bag
The disposal bag contains biohazardous material. Handle the disposal bag and its content in
accordance with the local regulations: Wear disposable gloves.

" Remove the cuvette disposal bin (the furthest unit on the right).
" Unfold the plastic disposal bag and lift it out of the metal bin.
" Take the cut off part of the plastic bag containing the cuvette roll that has been previously loaded
(see chapter 3.3.1 of this manual) and use it as a link to tie up the disposal bag.
" Dispose of the plastic bag by following the regulations in force locally.
The disposal bag contains biohazardous material and should therefore be disposed of in accordance
with the regulations in force locally.
" Take the plastic bag containing the cuvette roll that has been previously loaded (see chapter 3.3.1
of this manual) and use it as a disposal bag for the cuvette bin.
" Open the plastic bag and put it in the metal disposal bin.
" Make sure the bag goes all the way down to the bottom of the bin.
" Fold the bag down over the sides of the bin.
3-11
0931634 - October 2007
Routine use
REFERENCE MANUAL
" Put the metal cuvette disposal bin back into the STA-R Evolution; this bin should be pushed to
the back of its casing until you hear the bin detection switch turn off.
Do not defeat the operation of the switch that detects the presence of the metal cuvette disposal
bin.
3.3.3 Loading the cleaner solution
handled in accordance with the regulations in force locally: wear disposable gloves, mask and safety
goggles.
" Click the
icon and then press the
button.
The window below appears displaying
the message "Remove and
dispose of the Waste bottle. CAUTION: BIOHAZARD.".

disposed of in accordance with the regulations in force locally:
" Gently remove the 2.5 liter container of waste solution represented on the screen in blue (the
middle 2.5 liter container shown in the photograph above).
" Remove the cap from this 2.5 liter container as soon as possible.
Note: The symbol on the cap and the tubing leading to this cap is red to indicate that the contents
of the 2.5 liter container is biohazardous.
" Completely remove the 2.5 liter container of waste solution,
3-12
0931634 - October 2007
REFERENCE MANUAL
Routine use
The window below appears, displaying

move the Cleaner Solution Bottle.".
the message "Empty then
" Put the original screw on cap back onto the waste container and dispose of it in accordance with
the regulations in force locally.
Using permanent ink pen, mark the container of used solution "WASTE"; never use it as a new
vial of STA-Cleaner Solution; this can lead to incorrect results.
Note: The empty 2.5 liter container of STA-Cleaner Solution will be used as the new 2.5 liter
container for waste solution.
" Gently pull the empty 2.5 liter container of STA-Cleaner Solution (left-most 2.5 liter container).
" Remove the cap from this 2.5 liter container as soon as possible. Let the pipe hang outside the
analyzer so as to avoid any possible contamination.
" If necessary, empty the 2.5 liter container of STA-Cleaner Solution.
" Set the empty 2.5 liter container in front of the middle position so that you can put the cap and
the red tubing on to the empty container. Using permanent marking pen cross out the words
"STA-Cleaner Solution" found on the label. Mark the word "WASTE" on this container.
" Push the empty 2.5 liter container to the rear of its casing.
following window will then appear
displaying the message "Install a new Cleaner Solution.".
Do not defeat the operation of the switch that detects the presence of the 2.5 liter container of
waste solution.
3-13
0931634 - October 2007
Routine use
REFERENCE MANUAL
" Take a new 2.5 liter container of STA-Cleaner Solution.
The new STA-Cleaner Solution bottle must be at ambient temperature.
Do not swallow the STA-Cleaner Solution (in vitro use).

Do not modify its composition, it could lead to wrong results.
" Remove its cap.

" Put the 2.5 liter container of STA-Cleaner Solution in front of the left-most free area so that you
can put the pipe and the cap on it.
" Push the full 2.5 liter container to the rear of its casing.
following window will then appear:
15
displaying the message "Indicate the volume.".

" Confirm the volume indicated (2500ml) by clicking
enter the remaining volume and then confirm by clicking
if a new vial is used. If not,

.
3-14
0931634 - October 2007
REFERENCE MANUAL
Routine use
3.4 Loading/unloading the products

3.4.1 Warnings related to loading products
For all loading operations, do not defeat the various motions of the analyzer and to avoid confusion,
For all products (reagents, controls, calibrators, dilution buffer and decontaminating solutions),
please read carefully the notes that accompany each product and follow the procedures described.
Manual identification of product can lead to typing errors. It is used under complete responsability of
the user.
It is recommended not to turn off the STA-R Evolution. That allows the storage of the products on
board and their stability management.
Note: The LEDs next to the vial flash for products that are no longer valid in terms of volume and/
or stability and/or expiry date.
The expiry date and the lot number of the following products are not controlled by the analyzer:
STA-OWREN KOLLER buffer (TOK), STA-Desorb U solution, STA-CaCl2 reagent.
The operator must therefore check the expiry date of these products before loading them in the
analyzer.
Only the stability and volume of these products are controlled by the analyzer.
The stability of reagents which have been loaded and then reloaded are not controlled by the
analyzer and remains on the entire responsability of the user.
3.4.2 Open the Products drawer
You must use the software to open the Products drawer; do not attempt to open it manually.
3-15
0931634 - October 2007
Routine use
" Click the
REFERENCE MANUAL
icon,
" Click the Open tab,

If the STA-R Evolution is pipetting products from the drawer or needs the drawer to finish the
analyses in progress, a flashing window appears at the bottom of the screen and displays the
message "Open Drawer - Estimated Time x min. x s" and the estimated lapse of time before
opening.
" Click Cancel to cancel the request to open,
If not, the message "Drawer is about to open" is displayed.
Do not block the automatic opening of the Products drawer.
When the STA-R Evolution is ready to open the products drawer, the message disappears and
the tab heading Opening changes to Open Drawer. The drawer opens, the product bar code
reader lights and a beep sound is produced. Once the drawer is open, the tab heading changes
to Close Drawer.
If the drawer opens immediately, no message is displayed; and the events proceed as described
above.
Note: While the products drawer is open, sampling is stopped and no function other than contextual
help is accessible.
When the drawer is open, do not put your hand or any object inside the STA-R Evolution.
3.4.3 Loading a product with bar code identification

" Place the vials bar code label in front of the products bar code reader. If the bar code reader does
not work properly, you need to identify the products manually (see procedure in chapter 3.4.4
of this manual).
" If the contents of the vial have been decanted to a STA<-microcup, check the empty box beside
, by pressing the F8 button or by clicking the empty area of the
button to display the
symbol,
3-16
0931634 - October 2007
REFERENCE MANUAL
Routine use
key to confirm,

" If a new lot number is detected, the following question is displayed "Do you wish to read the
reading, click
.
If the bar code reader fails to work properly, you need to enter the bar code information manually
For some methodologies, entering parameters such as the "reference time" or the ISI is
requested; the following window is then superimposed on the display:
3-17
0931634 - October 2007
Routine use
REFERENCE MANUAL
For Diagnostica Stago calibrators and controls, the values are correctly assigned in the appropriate
test if the primary unit selected for them is the same as the one defined in the barcode sheet in each
box of controls (except for Fibrinogen where for the primary unit in g/l, the values will be correctly
assigned even if they are given in mg/dl on the sticker).
The value of the ISI for Prothrombin should be the one indicated in the product note. Any change
in batch, any software update as for any intervention - should give rise to checking the ISI value.
3.4.4 Loading a product using manual identification

" Type the product identification as it is defined in the Test setup menu, then confirm by clicking
,
" If the contents of the vial have been decanted to an STA<-microcups, check the empty box beside
, by pressing F8 or by clicking the empty area of the
display the
button to
symbol,
" Type the batch number; then confirm by clicking

key to confirm,
3-18
0931634 - October 2007
REFERENCE MANUAL
Routine use
If a new lot number is detected, the following question is displayed "Do you wish to read the
reading, click
.
For some methodologies, the entering of parameters such as the "reference time" or ISI is
requested.
Note: For products that are not part of the STA< line, the threshold values must be entered for
controls, as well as the concentration values of the calibrators.
3.4.5 Loading a product without positive identification of the positions

If positive identification is no longer in operation for the product drawer (completely or partially), the
position of the vials can be entered manually.
This procedure requires extra attention from the operator, who must ensure that the positions
indicated in fact correspond to the positionings that have been carried out.
For all the tubes or vials that are loaded using this procedure (non-operational positive
identification), it is absolutely necessary to observe the unloading procedure without positive
identification.
If after loading the vial, the position is not displayed.

" Open the drop-down list of the
positions by clicking the
arrow,
" Click the position that corresponds to that of the vial. In the Products drawer, this position is
shown on the right side of the vial.
" Click
3-19
0931634 - October 2007
Routine use
REFERENCE MANUAL
3.4.6 Unloading the products using positive identification

This procedure is only possible if positive identification is operational: that is, automatic recognition
of the loading position in the drawer by the STA-R Evolution.
" Remove the vials one by one.
3.4.7 Unloading the products without positive identification

This procedure is absolutely necessary for products loaded when positive identification no longer
works.
" Look for the product to be unloaded (sort the products if necessary and use the vertical scroll
bar),
Reminder: The
letter symbol is displayed for the products that have been loaded without
positive identification.
" Click the product line,
" Simultaneously press the CTRL and DEL keys: the following question is displayed:
"Remove Product?
Identity - Product name
pos.: Product position"
" Remove the vial from the Products drawer; then click
to confirm.
3.4.8 Close the Products drawer
You must use the software to close the Products drawer; do not attempt to close it manually.
" Click the Close drawer tab,

" The drawer closes.
Do not block the automatic closing of the Products drawer.
3-20
0931634 - October 2007
REFERENCE MANUAL
Routine use
The heading of the Close drawer tab changes to Open drawer.

The software automatically displays the List of products screen.
Note: If one or more products is missing, the Missing Products window appears for 15 seconds
and an alarm rings at the same time.
You can:
-
run sampling,
open the drawer to load the missing products (the list of missing products is displayed when we
click the icon
),
block sampling.
3.4.9 Enter the bar code information manually

This procedure is to be followed if the bar code reader does not operate normally (reader problem
or bar code printing problem).
After the question "Do you wish to read the calibration parameters using the barcodes?" to
accept click
, Reading the Bar Code Stickers window now appears.
" Double click "Please pass the label in front of the barcode reader",
" Enter the information provided below the bar code and use the
of each line.
" When you have entered all the lines, click
" Click
key to validate it at the end
3.4.10 Sorting products - Product list screen

correspond to the 8 columns in the List of Products, screen, that is: ID, Product Name, Type,
Pos., Lot, Shel-life, Expiry date, Volume on board.
This procedure can be implemented whether the drawer is open or closed.
3-21
0931634 - October 2007
Routine use
" Click the
REFERENCE MANUAL
icon,
" Click the List of Products tab (to perform the sort with the drawer closed) or click the Open
tab (to perform the sort with the drawer open),
" Click the column heading that matches the criterion that the sort is to be performed on.
When you click ID, you sort the products by increasing identification.
When you click Product Name, you sort the products alphabetically.
When you click Type, you find the controls at the top of the list, followed by the diluents, the
calibrators, the cleaning solutions and finally the reagents.
When you click Pos, the products are sorted by their location in the drawer (R0, R1 and last,
R2). Inside each zone, they are sorted by increasing position.
When you click Lot, the products are sorted by ascending batch number.
When you click Stab., the products are sorted by increasing stability.
When you click Date-Hour, End of use, you find the products whose expiry date and time are
the closest at the top of the list.
When you click On board, the products are sorted by ascending on board volume.
3.4.11 Sorting products Forcecast Screen

This screen allows you to visualize quickly the missing volumes of products required to carry out the
work load.
correspond to the 4 columns in the Forecast screen, that is: R., ID, Product name and Margin.
" Click the
icon,
" Click the Forecast tab,

" Click the column heading that matches the criterion that the sort is to be performed on (R., ID,
Product name or Margin).
When you click R, the products are sorted by location int the drawer (R0, R1 and last, R2).
When you click ID, the products are sorted by ascending ID.
When you click Product name, you find the products whose names begin with a, then b and
so on at the top of the list.
When you click Margin, the products are sorted incrementally by volume: the missing products
are at the top of the list.
3.5 Quality control

If the result of a quality control does not meet the norms, all the results since the last correct quality
control with a validated status should be called into question.
Security levels (passwords) may be defined for some functionalities related to quality controls (see
procedure in chapter 5.14 of this manual).
3-22
0931634 - October 2007
REFERENCE MANUAL
Routine use
3.5.1 Running a quality control manually

You run a quality control from the quality control menu.
" Click the
icon,
" Look for the test for which a control is to be run,

" Click the
button,

Run the control?"
" Click
to confirm.
Note: The
icon in the system panel flashes if a quality control is to be validated or is
erroneous. This icon may be accompanied by a ringing alarm if this option has been selected in the
Global Options screen, Miscellaneous section (see procedure in chapter 5.11.5 of this manual).
If the
icon flashes in the system panel:
icon,
The Daily Controls screen appears with the cursor on the last quality control result ("To be
validated" or "Erroneous").
" Place the cursor on the quality control that is to be run,
" Click the
button,

Run the control?"
" Click
to confirm.
3.5.2 Validating a quality control result
If the results of the quality controls do not meet the norms, all results since the last good quality
control should be put into question.
3-23
0931634 - October 2007
REFERENCE MANUAL
Routine use
A quality control can be validated either by using the flashing

be going to the quality control menu.
icon in the System panel, or
Note: the flashing

icon displayed in the system panel indicates if a quality control result needs
to be validated or is erroneous. This icon may be accompanied by a ringing alarm if this option has
been selected in the Global Options screen, (Miscellaneous section).
icon,
" Place the cursor on the quality control that is to be validated,
" Click the
button,

Level x
" Click
to confirm,


" Click the
icon,
" Look for the test for which a control is to be validated,

" Click the
button,

Level x
" Click
to confirm.

3-24
0931427D - October 2007
REFERENCE MANUAL
Routine use
3.5.3 Deleting a quality control result

A quality control can be deleted either by using the flashing
going to the quality control menu.
icon in the System panel, or be
Note: the flashing

icon in the system panel is displayed if a quality control is to be validated
or is erroneous. This icon may be accompanied by a ringing alarm if this option has been selected in
the Global Options screen, (Miscellaneous section).
icon,
" Place the cursor on the quality control that is to be deleted,
" Click the
button,

Level x
" Click
to confirm.


" Click the
icon,
" Look for the test which a control is to be deleted for,

" Click the
button,

Level x
Click
to confirm.
3-25
0931634 - October 2007
REFERENCE MANUAL
Routine use
3.5.4 Display the days controls

" Click the
" Click the
icon,
icon,
The Daily controls screen appears:
For each quality control value, the following information is displayed:

-
ldentity,
the minimum and maximum acceptance thresholds,
the unit.
In the table, the following information is displayed:

-
the abbreviation for the test (identified by the Test column heading on the screen),
the level of the control (identified by the Level column heading on the screen),
the result (identified by the Result heading on the screen),
the time (identified by the Time heading on the screen),
the condition for running the control:
automatically run depending on time
3-26
0931634 - October 2007
REFERENCE MANUAL
Routine use
automatically run as a function of the number of tests

automatically run at each change of vial
run manually by the operator
the status.
You can sort the daily controls according to a type of information (test abbreviation, result, etc.) by
clicking the heading of the column you want to use.
You can sort in reverse order by clicking the heading twice.
The order of the sort is used when the document is printed.
Note: You can validate, delete or rerun a control by double-clicking or right-clicking the control.
3.5.5 Displaying the last quality control result

Purpose: To return to the last quality control performed when you moved to the various graphical
areas on the Quality control screen.
" Click the

button: the data related to the last control carried out is displayed in the various
areas of the Quality control screen.
Another procedure may be used to display the last control carried out:
" Click the abbreviation for another test,
" Click the abbreviation for the test you want again.
3.5.6 Printing the days controls

" Click the
" Click the

" Click icon
printed.
icon,
icon,
to print the days controls; all information concerning the control will be
All the days controls are printed.

For each quality control value, the following information is printed:
-
the abbreviation for the test (identified as Test at the time the controls are printed),
3-27
0931634 - October 2007
Routine use
-
REFERENCE MANUAL

is printed),
the time and date (identified as Date at the time the controls are printed),
the status (identified as Status at the time the controls are printed),
The information entered in the Global Options menu (Title 1 and Title 2) are printed on every page
at the bottom left of each page.
The pages are identified by their page number / total number of pages.
3.5.7 Displaying and printing the quality controls for a given period
" Click the
" Click the
icon,
icon,
The daily controls window appears.
" Click the
icon,
3-28
0931634 - October 2007
REFERENCE MANUAL
Routine use
" Use the arrows to select the range you want and then by click
period.
to confirm the
The daily controls for the requested period are displayed:
" Click icon
to print.
Note: The commands Validate, Rerun or Delete are only activated for the daily controls (selection
of the control on the days date + right click).
3.5.8 Printing a quality control in graphical mode

" Click the
icon,
" Look for the test for which the quality controls are to be printed,
" Select a point on the graphic (see procedure in chapter 5.9.8.1 of this manual),
" Click the
icon to print.
3-29
0931634 - October 2007
Routine use
REFERENCE MANUAL
" Select Current level: 1. or All Levels. to print only the current level or all quality control levels.
All information related to the point selected will be printed.
On each page (table pages and graphics pages):
-
the abbreviation for the complete test name (identified as Methodology when the control is
printed),
is printed),
the time and date of the result as well as the value of the point selected,
On the tables page:

-
Table for the selected day

- the time (identified as Time when the control is printed),
- the result (identified as Result when the control is printed),
- the type of operation (identified as Running when the control is printed),
- the batch,
- the minimum value (Min) and maximum value (Max),
Table of daily totals

- day of the month (identified as Date when the table is printed),
- mean of the quality controls every day of the month (identified as Mean when the table is
printed)
- standard deviation of the quality controls every day of the month (identified as Sigma when the
table is printed)
Table of monthly totals

- number of the month (identified as Date when the table is printed),
- mean of the quality controls for every month (identified as Mean when the table is printed)
- standard deviation of the quality controls for every month (identified as Sigma when the table
is printed)
On the graphics page:

-
graph of daily controls

graph of daily totals
graph of monthly totals
3-30
0931634 - October 2007
REFERENCE MANUAL
Routine use
3.5.9 Changing the values of the thresholds for a quality control

" Click the
icon,
" Look for the test whose control threshold values are to be changed,
" Click the
button,
The Change thresholds window appears with the new values to be entered as well as the
original values.
" Enter the new thresholds,
" Click
to confirm.
3.5.10 Transmitting a control result

" Click the
icon,
" Look for the test whose control is to be transmitted,

" Click the
button,

Level x
Do you want to upload this point?"
" Click
to confirm.
3.5.11 Deleting all quality control results for a level

" Click the
icon,
" Look for the test for which all quality control results are to be deleted,
3-31
0931634 - October 2007
REFERENCE MANUAL
Routine use
" Click the
button,

"Test: Abbreviation of the selected test
Level: Selected level
ATTENTION!!! Do you want to delete all the QC points?"
" Click
to confirm: all quality control results for the displayed level are deleted.

The typed comment is associated to every deleted point.
3.6 Loading/unloading the samples
For all loading operations, do not block the various motions of the analyzer and to avoid confusion,
Manual identification can lead to typing errors. It is used under complete responsability of the user.
3.6.1 Loading a Patient tube
Only use centrifuged tubes for the samples; check that there is enough plasma, that there is no foam
and that no clot or micro-clot might interfere with the results.
Use the green pediatric rack for the loading of pediatric sample tubes and the blue rack intended
for microcontainers for the loading of microcontainer sample tubes.
When a microcontainer rack is loaded, make sure that the number of the rack is displayed in blue
in the test panel and that the microcontainer status is given to the patient in the Patient Acquisition
screen.
3-32
0931634 - October 2007
REFERENCE MANUAL
Routine use
It is recommended to use a bar code label to identify the sample tubes. This can be printed by the
STA-R Evolution, see procedure in chapter 4.10.1 of this manual. You can also load tubes without
labels.
Please choose the case that corresponds to your situation:
Loading tubes with automatic identification by the bar code reader:
3-33
0931634 - October 2007
REFERENCE MANUAL
Routine use
Standard loading
Emergency (STAT)
loading
Test selection
Procedure
Chapter
Downloading
Case n1
3.6.2
Automatic profile
Case n2
3.6.3
Case n3
3.6.4
Case n4
3.6.5
and automatic
incrementation
Case n5
3.6.6
Case n6
3.6.7
Case n7
3.6.8
NOTES:
When loading tubes, if the list of tests is downloaded, the operator should check coherence between
patient identity and the list of tests for this patient.
Manual entry of information is the operators responsibility.
The operator should use 2 bar code types at most to:
-
optimize bar code reading speed for the aforementioned bar codes,
limit the risk of bar code reading error related to the number of bar code types to be recognized.
A rack should never be loaded without the tray except when emergency loading is taking place.
When emergency loading is taking place, you must nonetheless wait until the analyzer invites you to
load the rack before introducing it into the analyzer.
If a rack has come out of the rack anti-fall device unexpectedly, the user should remove this rack
with care, stop the analyzer using the
button and then restart the software for the analyzer.

-
Selecting tests for downloading
" Click the
icon,
3-34
0931634 - October 2007
REFERENCE MANUAL
Routine use
icon to automatically read and load the tubes,
or the
icon if you want the unread tubes to be automatically unloaded for identification
(this option is selected through the screen Global Options, see chapter 5.12 of this manual,
" Check the Downloading checkbox to display the
symbol.

" Put the rack tray into the analyzer: The tubes are automatically loaded, their bar codes are read
and for each tube, the request for the work list is made to the central server. The analyzer
automatically performs the analyses.


-
Selection of tests by automatic profile
" Click the
icon,

icon if you want
" If necessary, define the automatic profile (see procedure in chapter 3.7.2.1 of this manual),
" Check the Add Automatic Profile checkbox to display the
symbol.

" Put the rack tray on the analyzer: The tubes are automatically loaded, their bar code labels are
scanned and the test profile is added to each patient identification. The analyzer automatically
3-35
0931634 - October 2007
REFERENCE MANUAL
Routine use


-
Manual test selection
" Click the
icon,

icon if you want
" Put the rack tray into the analyzer:
The tubes are automatically loaded and their bar code labels are read,
" Add the tests: either through the Test panel or through the Patient Acquisition screen; see
, when a tube is not read at loading time, it
is automatically taken to the stat loading position and the Manual Input of patient IDs window

" Click the
icon,

icon or the
icon),

patient IDs screen appears:
3-36
0931634 - October 2007
REFERENCE MANUAL
Routine use
" Double click the
).
" Locate the picture of the rack found at the bottom left of the Manual Input screen. Double click
on the position of the sample tube within this rack. Manually enter the patient identity and status.
-

patient IDs menu.
" Click
to confirm.
On loading, the bar code reader checks coherence between rack positions and the information that
has been entered. If there is a mismatch, the following message is displayed:
"There are IDs without a tube.
or
"There are tubes without a corresponding ID.
or
"There are tubes without an ID and IDs without a tube.
You can:
-
ignore this step; in this case, the analyzer only works with tubes that are actually physically
present,
3-37
0931634 - October 2007
REFERENCE MANUAL
Routine use
-
re-display the Manual Input of patients IDs screen to correct the error by clicking
.
3.6.6 Loading a rack of tubes / manual identification mode Case n5

" Click the
icon,

icon or the

icon),

patients IDs screen appears:
" Double click the

" Click the
).
button,
The Incrementation options screen appears:
3-38
0931634 - October 2007
REFERENCE MANUAL
Routine use
" You can enter the following information:

-
the prefix,
the starting number,
the incremental value,
the status,
the type of profile.
" Click the
button,
The incrementation options are applied to all samples.

Note: All identities, statuses or tests can always be changed manually.
" Load the first rack by clicking

, or load all the racks by clicking
(in this case, the
incrementation options are applied to all samples but no change is possible).
Note: If all the racks must be loaded
, the following message appears:
"Do you want to load all the racks with an automatic ID incrementation?"
" Click OK to confirm
Note: When a stat loading is requested in the manual identification mode, the stat checkbox is
checked by default (this checkbox can be cleared during the loading).
During the loading process, the bar code reader checks the coherence between the rack positions
and the information that has been typed manually. If there is an incoherence, the following message
appears:
-
In case of individual rack loading
"There are IDs without a tube

" Click Unload.
The rack is taken out and the Manual Input of patient IDs window appears.
" Click Ignore.
The rack is loaded and only the identities detected by the bar code reader appear in the test
panel.
3-39
0931634 - October 2007
REFERENCE MANUAL
Routine use
In case all the racks should be loaded
"Warning
There are IDs without a tube
Rack/Position: xxxxxx/x"
" Click OK to confirm.
This message is displayed as information; the analyzer only works with the tubes that are
physically present.
3.6.7 Urgent (STAT) loading of a rack of tubes / manual identification mode Case
n6
" In the Test Panel tab, check that the

then click the
icon or the
icon is displayed (if it does not appear on the screen,
icon),

" Click the
icon,

"Please make sure there is no rack in loading position before the end of Initialisation.
Press OK to Continue.".
" Click
to confirm,
The Manual Input of patient IDs screen appears:
Note: When entering information, do not use the following characters:

&, , ", (, -, , _, , , ), =
" Click the position of the rack in the drawing,
" Enter identity and status
3-40
0931634 - October 2007
REFERENCE MANUAL
Routine use

patient IDs menu.
" Click
to confirm the information entered
" Load the rack into the STAT position

Transferring the rack to the analyzer.
3.6.8 Urgent (STAT) loading of a rack of tubes / automatic identification mode

Case n7
Manual selection of tests by downloading or by automatic profile
" In the Test panel tab, check either the
icon to automatically read and load the tubes, or
the
icon if you want the unread tubes to be automatically unloaded for re-identification
(this option is selected through the Global Options screen, see chapter 5.12 of this manual,
" Click the
icon,

"Please make sure there is no rack in loading position before the end of the
initialisation.
Press OK to continue.".
3-41
0931634 - October 2007
Routine use
" Click
REFERENCE MANUAL
to confirm,
" Load the rack into the STAT position: the rack is automatically loaded; its bar code labels are
read and for each tube, the request in the work list that was made to the server or the automatic
profile is applied if one of these options has been selected.
The analyzer automatically performs the analyses.
Note: If the Downloading option or the Automatic profile option has not been selected,
enter the analyses to be carried out:
- From the Manual Input of patient IDs menu: by selecting one of the six pre-defined profiles
- From the Test panel: by double clicking the test abbreviation
3.6.9 Tagging racks

Selects racks in order to unload them or to associate an action with them (Print/Download).
" Click the
icon,

" Move the cursor to the rack that you want to tag (vertical scroll bar),
" Click
column,
to tag the rack (or click directly inside the T column): the
sign appears in the T
3.6.10 Tagging all racks

" Click the
icon,
3-42
0931634 - October 2007
REFERENCE MANUAL
Routine use

" Click Tag All,
sign appears in the T column (rack tagged).
3.6.11 Removing the tag from all the racks

" Click the
icon,

" Click Untag All,
sign disappears from the T column.
3.6.12 Removing the tag from some racks

" Click the
icon,

" Move the cursor to the rack whose tag is to be removed (vertical scroll bar),
" Click
to remove the tag from the rack (or click directly inside the T column): the
disappears from the T column,
sign
3.6.13 Sorting the racks

The racks may be sorted by one of 2 criteria. This criteria is the Rack and Status columns.
" Click the
icon,

" Click the heading of the column that matches the criterion which the sort is to be done on (Rack
or Status).
For example, by clicking Rack, you find the racks with numbers beginning with 0 at the top of the
list, then with 1 and so on until you reach the rack number beginning with 9.
When you click Status, the racks inside the analyzer show up at the top of the list in loading order;
then you have the racks that were unloaded and that are in the tray.
3-43
0931634 - October 2007
Routine use
REFERENCE MANUAL
3.6.14 Printing the list of racks

" Click the
icon,
" The list of racks is printed:
3.6.15 Unloading a rack

" Click the
icon,

" Double click the rack to be unloaded,
"Unload a rack?
Rack: xxx?".
" Click
to confirm,
3-44
0931634 - October 2007
REFERENCE MANUAL
Routine use
When transferring the rack to the tray, the icon representing the rack becomes
Make sure that you position the rack correctly in the tray before unlocking the tray and removing it
from the analyzer.
" Click the
3.6.16 Unloading several racks

" Click the
icon,

" Tag the racks to be unloaded; see procedure in chapter 3.6.9 of this manual,
" Click

" Click
to confirm,
When transferring the racks to the tray, the icon representing the rack becomes
You must then release the tray before you can remove it from the analyzer.
" Click the
3.6.17 Unloading all the racks

" Click the
icon,
3-45
0931634 - October 2007
REFERENCE MANUAL
Routine use
" Tag all the racks; see procedure in chapter 3.6.10 of this manual,
" Click

Click
to confirm,
When transferring the racks to the tray, the icon representing the racks becomes
The tray is automatically released.
3.6.18 Reloading a rack after the unloading of a tube

After unloading one or several racks to take one or several tubes out, the rack(s) located on the tray
can be reloaded with the
rack(s).
button. It allows the resuming of tests for the other tubes of the
" From the (Un)loading tab, unload the rack(s) containing the tube(s) that must be unloaded (see
chapters 3.6.15 and 3.6.16 for the unloading of racks).
The rack is transferred to the tray and the reloading button appears on the right of the button for
the unloading of tagged identities.
The reloading button appears if:

- the Automatic Unloading mode is not activated
- a tube identity can be reloaded
A tube identity can be reloaded if:
- at the first loading, the identity (bar code) of the tube is correctly read (the tube is not identified
as a unread tube)
- at the first loading, this identity has not been modified using manual identification or automatic
identification
If an identity cannot be reloaded, it is archived when the reloading of the tray is complete.
" Remove the requested tube(s).

" Click
to reload the rack(s) on the tray.

Do you want to reload the racks being on the tray?
Click
to confirm.
The operation is automatically canceled if, after 10 seconds, the reloading of the racks is not
confirmed.
3-46
0931634 - October 2007
REFERENCE MANUAL
Routine use
The rack is reloaded in the analyzer and the analyses are resumed.
Identification of reloaded tubes

- Reloading a rack in automatic identification mode:
When racks are reloaded, tubes barcodes are reread one after the other.
Missing tubes are automatically archived.
Present tubes are replaced on the test panel and their workload is resumed.
- Reloading a rack in manual identification mode:
If the rack had been loaded in manual identification or autoincrementation mode, the manual
identification of the same identities is allowed.
If the rack had been loaded in automatic mode, manual identification or autoincrementation
determination of a barcoded identity which is likely to be reloaded is forbidden (a message appears
for 10 seconds).
The previous results are then archived and restored in the test panel.
Any rerun on a given result will overwrite it.
Beside, all the tubes in the rack identified as unread tubes and are automatically archived with the
status "in progress". These tubes cannot be restored in the test panel.
Unloading a tube requiring an automatic rerun (with or without redilution)
-
If a test must be rerun and the relevant tube is on the tray when the result of the measurement
implying the rerun is given, the test takes an "Error" status in the test panel.
If the patient files are archived (for example if the tray has been removed), they will not be rerun
if they are resumed. However, if the tube has been reloaded before the measurement result is
given, then it will be rerun (see chapter 5.4.7 of this manual).
3.6.19 Release the tray

" Click
The tray is released; the area around the tray changes from red to green indicating that the tray
can be removed.
3-47
0931634 - October 2007
Routine use
REFERENCE MANUAL
3.7 Processing patient files

3.7.1 Tagging patient files
3.7.1.1 Tagging patient files Control panel

" Click the
icon,

" Move the cursor to the file that you want to tag (vertical scroll bar),
" Click
to tag the file or click on the file to be tagged in the T column: the
in the T column,
sign appears
3.7.1.2 Tagging all the patient files

" Click the
icon,

" Click Tag all
sign appears in the T column.
3.7.1.3 Tagging patient files - Archives Menu

" Click the
" Click the
icon,
" Click Search By.

" Choose the search key by clicking Identity, Name, First Name (these three keys correspond
3-48
0931634 - October 2007
REFERENCE MANUAL
Routine use
" Click Search.

" Click
to confirm.

" Then, click Tag all,
" or move the cursor to the file that you want to tag (vertical scroll bar),
to tag the file or click on the files that you want to tag in the T column,
" Click
sign appears in the T column for all tagged files,
The

" Click the
Note: in order to search a patients file loaded in the past according to his/her identity, start the
research by date and then by identity.
3.7.1.4 Removing the tags from all the patient files

" Click the
icon,

" Click Untag all,
sign disappears in the T column.
3.7.1.5 Removing the tag from a patient file

" Click the
icon,

" Move the cursor to the file whose tag is to be removed (vertical scroll bar),
" Click
to remove the tag from the file or click on the file in question in the T column: the
sign disappears from the T column,
3-49
0931634 - October 2007
Routine use
REFERENCE MANUAL
3.7.2 Adding a test
3.7.2.1 Defining or changing a test profile

" Click the
icon,

" Click the
button,
" Click Automatic (profile for loading racks) or Profile nx (x = number of the profile to be
defined or changed): the tests included in the profile are identified by a green triangle
" Click the
button.
" Select the tests you want by clicking the abbreviation of the displayed tests (use the scroll bar to
look for each test's abbreviation): a green triangle
appears. To remove a test that has already
been selected, click it again; the green triangle will disappear.
" If the samples are stat, choose Yes in the STAT File area,
" In the Sample Type area, choose the type of sample tubes: Standard for 5 ml tubes, Tainer
for plasmas transferred in micro-containers or Pediatric for 3ml tubes;
" Click the
button,
The list of tests associated with the profile is displayed
3-50
0931634 - October 2007
REFERENCE MANUAL
Routine use
3.7.2.2 Adding a test to a patient file in the test panel

" Click the
icon,
" Use the
" Look for the test that you want to add to the patient file using the horizontal scroll bar (bottom),
" Double click the test checkbox,
"Add a test?
" Click the
button to confirm,
The selected test is added.
3.7.2.3 Adding one or more tests to a patient file Patient Acquisition screen
" Click the
icon,

" Click the
icon,
" Click the abbreviation of the test to be associated (use the scroll bar if the abbreviation for the
test does not appear in the list),: a green triangle
tests.
" Click the
appears. Repeat this procedure to add other
button.
3.7.2.4 Adding a test to several patient files

" Click the
icon,
" Use the
3-51
0931634 - October 2007
Routine use
REFERENCE MANUAL
" Tag the files for which the test is to be added,

The
" Click Add,
"Add Test for all Tagged Identities?
" Click the
button to confirm: for all the tagged files; the selected test will be added.
3.7.2.5 Adding a test profile to a patient file

" Click the
icon,

" Click the
icon,
" Click the profile to be applied (to view the tests for the profile, click
" To delete the tests applied to the patient file, click the
" Click the
),
button,
button.
3.7.2.6 Adding a test profile to several patient files

Note: You can edit 6 different profiles using 10 tests at the most for each profile.
" Click the
icon,

" Tag the files for which the profile is to be applied by clicking the files to be tagged in the T column,
The

" Click Apply Profile to Tagged Identities,
"Apply Profile for All Tagged Identities?
Profile No. x (x= number of the profile that you want to add)"
3-52
0931634 - October 2007
REFERENCE MANUAL
Routine use
" Click the
button to confirm.
The profile is applied to all the files selected.
3.7.2.7 Downloading the work list

" Click the
icon,
" Use the
" Tagging the file to be downloaded,

The
sign appears in the T column for the tagged file,

" Click Download Tagged Identities,
"Download All Tagged Identities?".
For all tagged files, the request for the work list is made to the server. The analyzer automatically
3.7.3 Blocking/unblocking tests
3.7.3.1 Blocking sampling

" Click the
icon,
" Click the
button
All sampling is blocked. The

panel.
button is displayed and the
icon flashes in the control
3.7.3.2 Blocking a test for all the patient files

" Click the
icon,
3-53
0931634 - October 2007
Routine use
REFERENCE MANUAL

" Click Block,
"Block all tests for this methodology?
" Click the
button to confirm
All the tests on the waiting list are blocked and the test abbreviation and the unit (column heading)
turn brown.
Note: The
this manual).
icon is displayed when the blocked test is run (see procedure in chapter 3.7.2.4 of
3.7.3.3 Blocking a test for a selection of patient files

Note: It is possible to block a test for a selection of patient files only if the test has been run and is
waiting to be processed (
icon). Moreover, the first sampling can be run for the first patient file
displayed on the test panel, even if it has been blocked.

" Click the
icon,

" Tag the patient identities to block (see procedure in chapter 3.7.1 of this manual),
" Click Block Tagged Identities,
"Block Test for all Tagged Identities?
" Click the
button to confirm
The test is blocked for all the selected patient files. The
icon is displayed in the column
corresponding to the blocked test.
3.7.3.4 Unblocking sampling

" Click the
icon,
3-54
0931634 - October 2007
REFERENCE MANUAL
" Click the
Routine use
button
All sampling is unblocked and the
button is displayed.
3.7.3.5 Unblocking a test for all the patient files
" Click the
icon,

" Click Unblock,
"Unblock all tests for this methodology?
" Click the
button to confirm
All the tests are unblocked and the test abbreviation and the unit (column heading) turn black.
3.7.3.6 Unblocking a test for a selection of patient files
" Click the
icon,

" Click Unblock Tagged Identities,
"Unblock Test for all Tagged Identities?
" Click the
button to confirm
The test is unblocked for all the selected patient files.
3-55
0931634 - October 2007
Routine use
REFERENCE MANUAL
3.7.4 Rerunning a test
3.7.4.1 Rerunning a test for a patient file in the test panel
" Click the
icon,
" Use the
" Double click the test checkbox (result displayed),
measurements),
"Rerun a test?
" Or for assays in duplicate, double click Rerun Measurement No. 1 (only reruns the first
measurement) or Rerun Measurement No. 2 (only reruns the second measurement),
Click the
button to confirm.
3.7.4.2 Rerunning a test from the Patient File screen

" Click the
icon,
" Use the
" Double click the test,
measurements),
"Rerun a test?
3-56
0931634 - October 2007
REFERENCE MANUAL
Routine use
" Or for assays in duplicate, click Rerun Measurement No. 1 (only reruns the first measurement)
or Rerun Measurement No. 2 (only reruns the second measurement),
" Click the
button to confirm.
3.7.4.3 Rerunning a test for several patient files
" Click the
icon,
" Use the
" Tag the files for which the test is to be rerun,

The
measurements),
" Or for assays in duplicate, double click Rerun measurement No. 1 (only reruns the first
measurements) or Rerun measurement No. 2 (only reruns the second measurements),
(Measurement No. 1) or (Measurement No. 2)
" Click the
button to confirm.
3.7.5 Deleting a test
3.7.5.1 Deleting a test for a patient file in the Control panel

" Click the
icon,
3-57
0931634 - October 2007
Routine use
" Use the
REFERENCE MANUAL
" Double click the test checkbox that has the result displayed or shows an icon:
(tube missing)
calibration),
(product missing)
(test blocked)
(test blocked because of lack of
" Click Delete,

"Delete a Test?
" Click the
button to confirm.
3.7.5.2 Deleting a test for several patient files

" Click the
icon,
" Use the
" Tag the files for which the test is to be deleted,

The
" Click Delete,
"Delete Test for all Tagged Identities?
" Click the
button to confirm.
3.7.5.3 Deleting a test from the Patient File screen

" Click the
icon,
" Use the
3-58
0931634 - October 2007
REFERENCE MANUAL
Routine use
" Double click the test that has the result displayed or shows an icon:
(tube missing)
(test blocked)
(test blocked because of lack of calibration),
" Click Delete,

"Delete a Test?
" Click the
button to confirm.
3.7.6 Validating the results
3.7.6.1 Alarms associated with the results

Patient File Screen -
Button
quality control that is substandard or has not been performed
substandard quality control validated by the operator
detection of un-administered level for arm n1 (R0 area samples and products)
result in main unit is limited to the default values
result obtained after re-dilution
result rerun
reagent drawer temperature out of bounds
incorrect duplicate tolerance
The alarms associated with a result are classified by level of seriousness (from more serious to less
serious).
3-59
0931634 - October 2007
Routine use
REFERENCE MANUAL
3.7.6.2 Validating results Archives menu

" Click the
icon,
" Click the

" Click the
icon,
" Click Search By.

" Click Search.
" Click
to confirm.

triangle)
The

" Click
to confirm.
" Click the
3.7.6.3 Validating results in the Control panel

" Click the
icon,
triangle)
The

3-60
0931634 - October 2007
REFERENCE MANUAL
Routine use

" Click
to confirm.
" Click the
3.7.7 Viewing a result
3.7.7.1 Viewing the results

" Click the
icon,
" Click the Test panel tab, ten patient files are displayed.
" Use the vertical scroll bar to view the other files,
" Use the horizontal scroll bar to view the other tests,
" OR look for the file and then double click it to consult the full file.
3.7.7.2 Viewing a result (photometry) as a graph

" Click the
icon,
" Use the
" Double click the test check box displaying the measurement in progress icon (
or with a result displayed,
or
" Click Graphics (single assay),

" Or for the assays in duplicate, click Graphics No. 1 (viewing the graph for the first dosage) or
Graphics No. 2 (viewing the graph for the second dosage). The Graphics screen appears.
" Click the
Note: Viewing results of photometric measurement as a graph is only available for samples (this
functionality does not exist for calibrators or for controls).
Note: You cannot print photometric graphs.
3-61
0931634 - October 2007
Routine use
REFERENCE MANUAL
3.7.8 Transmitting results
3.7.8.1 Transmitting a patient file

" Click the
icon,
" Use the
" Double click the file identification: the Patient File screen appears,
" Click the
icon,

"Upload an identity?
" Click the
button to confirm,
Options, see chapter 5.12 of this manual, Miscellaneous section, see chapter 5.12.5 of this
3.7.8.2 Transmitting several patient files

" Click the
icon,
" Use the
" Tag the files to be transmitted,

The

" Click Upload Tagged Identities,
"Upload All Tagged Identities?"
" Click the
button to confirm,
3-62
0931634 - October 2007
REFERENCE MANUAL
Routine use
3.7.8.3 Transmitting a test for a patient file in the Test panel

" Click the
icon,
" Use the
" Double click the test checkbox (result(s) displayed),
" Click Upload,
"Upload a Result?
" Click the
button to confirm,
3.7.8.4 Transmitting a test for a patient file Patient File screen

" Click the
icon,
" Use the
" Double click the test (the result is displayed with Validated or To be validated status),
Click Upload,
"Upload a result?
ID: Identity of the selected patient".
" Click the
button to confirm.
3-63
0931634 - October 2007
Routine use
REFERENCE MANUAL
3.7.8.5 Transmitting a test for several patient files

" Click the
icon,
" Use the
" Tag the files for which the test is to be transmitted,

The
" Click Upload,
"Upload Test for all Tagged Identities?
" Click the
button to confirm,
3.7.8.6 Transmitting results Archives menu

" Click the
icon,
" Click the
icon,
" Click the files to be tagged in the T column to tag the files to be transmitted,
The

" Then click Upload Tagged Identites,
"Upload all Tagged Identities?"
" Click the
button to confirm
3-64
0931634 - October 2007
REFERENCE MANUAL
Routine use
" Click the
3.7.9 Moving a sample that has already been loaded to STAT sample
3.7.9.1 Moving a sample that has already been loaded to STAT sample - Test panel
" Click the
icon,
" Use the
" Double click the file identification,

" Click the
icon,
3.7.9.2 Moving a sample that has already been loaded to stat - Patient Acquisition screen
" Click the
icon,

" Click the patient file that is to be moved to stat,
" Click the
icon,
" Select Yes in the STAT File area,

" Click the
button.
3.7.10 Looking for a patient file

" Click the
icon,
3-65
0931634 - October 2007
Routine use
" Click the
REFERENCE MANUAL
icon,
" Click Search By,

" Choose the search key by clicking Identity (or Name or First Name that correspond to the
primary complementary information),
" Click Search,
" appearEnter the identification you are looking for (or some of the complementary information:
name or first name) and either click the
button or press the
key to confirm. The
cursor moves to the file that you want, or a Key not found... message is displayed.
3.7.11 Printing patient files

Printing patient files can be done from the control panel, the Archives menu or the User Menu
menu.
-
From the Test Panel: to print the validated files that have not yet been archived (all or only some
of them). The files are printed on one page (see procedure in chapter 3.7.11.1 of this manual).
In the Archives menu: to print validated and archived files (all or only some of them). The files
are printed on one page (see procedure in chapter 3.7.11.2 of this manual).
In the User Menu menu (located in the Maintenance

menu): to print any validated file
(regardless of wether the file is archived or not). The files are printed page by page. You can
customize printing of the files in this menu (see procedure in chapter 3.7.11.3 of this manual).
3.7.11.1 Printing a non-archived file from the control panel

" From the control panel, tag the patient files to be printed (see procedure in chapter 3.7.1 of this
manual),
" Click the
icon to print the tagged files.

" Click
to confirm.
3-66
0931634 - October 2007
REFERENCE MANUAL
Routine use
3.7.11.2 Printing an archived file
icon to access the archives.
" Tag the patient files to be printed (see procedure in chapter 3.7.1 of this manual),
" Click on the
icon or
" Click the T column heading then click Print All Tagged Files,
" Click
to confirm.
3.7.11.3 Customizing printing of an archived or an un-archived file

This function allows you to customize printing of patient files according to the specific needs of each
laboratory.
This function is available for validated patient files (files that are to be validated, are erroneous, in
progress or empty can not be printed).
Customizing printing is done in the User Menu tab,
To access this tab, no measurement may be in progress; the open and archived files are blocked.
Choose the files to be printed:
" Click the

" Click the
button,
The screen for selecting files to print appears.

" In the first drop down list, choose the type of file to display (open or archived files),
The list of files is displayed at the top right of the screen.
" To obtain information on a patient file, click it,
The information is displayed in a pop up window called "Information on the patient file" table
at the bottom of the screen.
" Double click the name of the file in the list of files to tag the files to be printed in duplicate.
The # sign appears to the left of the selected file.
" In the second drop down list, select the files to print:
-
Current file: The file selected from the list

Marked # not printed: the files tagged with the # sign in the list of files and that have never
been printed
Marked #: all the files tagged with the # sign in the list of files
3-67
0931634 - October 2007
REFERENCE MANUAL
Routine use
" Click the
icon to print the selected files.
The * sign appears to the right of the printed files.

Customize the titles:
The location and the type of information related to the files (patient identification, test names,
results) are unchangeable; only the titles of the headings or the extra remarks are defined by each
laboratory.
A single file per page is printed.
" Click the

" Click the
" Click the
button,
button,
The customization screen appears.

" Change the titles on the basis of the laboratory.
" Click the
icon,
The previous screen (for selecting files) appears. It is changed on the basis of the selected
parameters.
3.7.12 Changing the display of the test panel
3.7.12.1 Choose displaying the single/duplicate results in the test panel

This option is only available for the tests that have been carried out in duplicate and if the unit chosen
for display is the primary unit or the raw unit.
Note: a D for the tests in duplicate is displayed beside the unit.
" Click the
icon,

" Click Display Measurement,
" Click Measurements 1 and 2: display of both results in the main unit (or raw),
" Or click Mean: display of the mean in the primary (or the raw) unit.
3-68
0931634 - October 2007
REFERENCE MANUAL
Routine use
3.7.12.2 Choose the unit in which to display the results in the Control panel
For each test, you can choose the unit for control panel display.
" Click the
icon,

" Click Units: the units available for this test are displayed,
" Click the unit you want.
3.7.12.3 Sorting the patient files

File sorting criteria has 6 possibilities to choose from. These criteria match the 6 columns that have
information corresponding to the patient files. For example: T (tagging files), Identity,
(checkbox color), Rack, Po (Position in the rack), Sts (file specifics).
" Click the
icon,

" Click the heading of the column that matches the criterion which the sort should be done on
(Identity,
, Rack, Po or Sts).
For example, by clicking the Identity column, the results are sorted numerically and then
alphabetically.
When you click
, the patient files are classified in the following order: blue (file to be validated),
white (validated file), yellow (file in progress); red (erroneous file) and grey (empty file).
When you click Rack, you find the files for which the tubes have not been loaded at the top of the
list, then the files whose rack number begins with 0, then with 1 and so on until the rack numbers
beginning with 9. At the end of the list, you have the calibrators and the controls when these are
being processed.
When you click Po, you find the files for which the tubes have not been loaded at the top of the list,
then the files whose tubes have been loaded into position 1 in the racks, then those that have been
loaded into position 2 and so on. For a given category (for example, tubes loaded into position 1),
the files are listed in the order that the tubes were loaded.
When you click Sts, the stat files are at the top of the list in the order that the tubes were loaded;
then you have the non-stat files also listed in the order that the tubes were loaded.
" Or click the T column heading,
3-69
0931634 - October 2007
Routine use
REFERENCE MANUAL
" Then click Sort by Tag: all the tagged files are at the top of the list.
3.7.13 Adding a note to a patient file

To add an additional note to a patient identification, see chapter 5.10.2 of this manual.
3.8 Calibration
3.8.1 Running a calibration Calibration screen

The procedure to run calibration can only be used when a new batch is loaded for a reagent or when
no calibration has been run for the batch.
Note: The products have already been loaded.
" Click the
icon,
" Double click the test that is to be calibrated,

Note: If there is already a validated calibration with another batch number, you must click
before continuing with the procedure.
If two calibrations already exist for a test and a new batch is to be calibrated, you need to delete one
of the two existing calibrations.
" Click Calibrate...,
" Click
to confirm.
The Lot selection window appears:

" Double click the reagent(s) to be able to select the batch to calibrate,
3-70
0931634 - October 2007
REFERENCE MANUAL
Routine use
Batch number is displayed in green; the vial is present and is may be

used.
Batch number in red; the vial is present but cannot be used (insufficient
volume and/or stability overdue).
Batch number in gray; the vial is not present.
Unknown batch
Displayed if the vial is not present or if it is present but has calibration

parameters that have not been read.
Already calibrated
Displayed if the selected batch has been calibrated in the other curve.
" Click the batch to calibrate,

" Click
to confirm.
3.8.2 Automatic calibration

If there are already two calibrations for a test and if a new batch is to be calibrated, you need to delete
one of the two calibrations (otherwise the former one will be automatically deleted).
" Open the products drawer
" Follow the procedure for loading products as outlined in chapters 3.4.3 or 3.4.4
" When a new batch is detected, the following question is displayed : "Do you wish to read the
calibration parameters using the barcodes?", click
The Barcode reading of sheet screen appears.
" Hold the bar code label included in the kit in front of the bar code reader
3-71
0931634 - October 2007
REFERENCE MANUAL
Routine use
The product parameters are displayed in the window.
" Click
" If there is at least a methodology to calibrate, the following window appears:

" Double click the product for which you want to run a calibration; the following window appears:
3-72
0931634 - October 2007
REFERENCE MANUAL
Routine use
3.8.3 Changing a calibration point

" Click the
icon,
" Click the test for which a calibration point is to be changed,

or

" Double click the line that matches the point to be changed,
" Click Modify Point,
" Enter the new value for the calibration point in the Current value line;
" Click
to confirm
The letter M appears on the line.

3-73
0931634 - October 2007
REFERENCE MANUAL
Routine use
" Click
to confirm.
3.8.4 Changing the100% point

Note: This option is only offered if chronometric tests use % as the main unit and also have the linear
measurement scale and the inverse concentration scale. This allows the calibration curve to move
parallel to itself so as to move through the new point given in seconds that corresponds to 100%.
" Click the
icon,
" Click the test for which a 100% point is to be changed,

or

" Click Edit 100% Pt,
" Enter the time in seconds that corresponds to the value of the laboratorys 100% point,
" Click
to confirm,

" Click
to confirm.
3.8.5 Rerunning a calibration

Note: You cannot rerun a calibration if the test is pre-calibrated.
" Click the
icon,
" Click the test for which the calibration is to be rerun,

or

" Click Rerun this calibration,
Do you really want to rerun this calibration N#selected calibration ?"
" Click
to confirm.
3.8.6 Rerunning a calibration point

Note: You cannot rerun a calibration point if the test is pre-calibrated.
3-74
0931634 - October 2007
REFERENCE MANUAL
" Click the
Routine use
icon,
" Click the test for which a calibration point is to be rerun,

or

" Double click the line that corresponds to the point to be changed,
" Click Rerun Point,
"Do you want to rerun calibration point No. xx?"
" Click
to confirm. The calibration point is rerun once in the case of single determination
and twice in that of duplicate determination.
3.8.7 Resuming an initial calibration point

Purpose: Resuming a calibration point as set before the point was changed or deleted.
" Click the
icon,
" Click the test for which a calibration point is to be resumed,

or

" Double click the line that corresponds to the point to be resumed,
" Click Restore Init Point,
" Click
to confirm.
3.8.8 Resuming an initial calibration

Purpose: Resuming the calibration as set before it was changed.
" Look for the test which the calibration should be resumed,
or

" Click Retreive Initial Calibration?,
"Methodology abreviation of the test
Retreive Initial Calibration",
" Click
to confirm.
3-75
0931634 - October 2007
REFERENCE MANUAL
Routine use
3.8.9 Resuming the initial 100% point

Purpose: Resuming the 100% point as set before it was changed.
" Click the
icon,
" Click the test for which a 100% point is to be resumed,

or

" Click Modify Pt 100%,
" Enter the previous value of the 100% point for the laboratory in seconds (this corresponds to
Initial Value xx.x Sec),
" Click
to confirm,

" Click
to confirm.
3.8.10 Entering or changing the ISI and/or the reference time

" Click the
icon,
" Click the test for which the coefficient is to be changed,

or

" Click Edit Ref. Time and ISI,
" Click the ISI area; then enter the ISI coefficient value,
" And/or click the Reference Time area; then enter the laboratory reference time in seconds,
" Click
to confirm.
Note: If the reference time is modified, it is used as reference for the INR calculation.
3.8.11 Deleting a calibration point

" Click the
icon,
" Click the test for which a calibration point is to be deleted,
3-76
0931634 - October 2007
REFERENCE MANUAL
Routine use
or

" Double click the line that corresponds to the point to be deleted,
" Click Delete Point,
The letter D appears on the line.
" Click
to confirm.
3.8.12 Deleting a calibration

" Click the
icon,
" Click the test for which the calibration is to be deleted,

or

" Click Deleting this calibration...,
Do you really want to delete this calibration? #1"
" Click
to confirm.
3.8.13 Validating a calibration

A calibration can be validated either by using the
accessing the calibration menu.
icon flashing in the system panel, or by
Note: The
icon in the system panel flashes if a calibration is to be validated or is erroneous.
This icon may be accompanied by a ringing alarm if this option has been selected in the Global
Options screen, (Miscellaneous section).
" Click the
icon or double click the
icon flashing in the system panel,
" Look for the test for which the calibration is to be validated (identified with a
the text To be Confirmed is displayed beside the regression coefficient,
blue triangle):

" Click Validate the Regression Coefficient,
"The Regression Coefficient for this calibration
must be at least x.xxx
y-yyy"
3-77
0931634 - October 2007
Routine use
REFERENCE MANUAL
where:
-
x.xxx = value of the regression coefficient (this can be negative) entered in the Global Options
screen,
y.yyy = value of the regression coefficient for the calibration.
" Click
to confirm.
3.8.14 Canceling a calibration in progress

" Click the
icon,
" Look for the test for which the calibration in progress is to be deleted (identified with a
yellow triangle):
" Click Cancel the calibration in progress?,
"Methodology Test: xx
Do you really want to cancel this calibration?"
" Click
to confirm,
The previous calibration is automatically redisplayed.
3.8.15 Printing a calibration

" Click the
icon,
" Choose the test for which the calibration is to be printed,

Note: If there are several validated calibrations, click
calibration is to be printed.
" Click the
or
depending on which
icon,
3.9 Archives
From the Archives menu, you can also:
-
tag the patient files to be printed (see procedure in chapter 3.7.1.3 of this manual),
look for the patient files (see procedure in chapter 3.7.1.3 of this manual),
transmit the results (see procedure in chapter 3.7.8.6 of this manual),
validate the results (see procedure in chapter 3.7.6.2 of this manual),
print the results (see procedure in chapter 3.7.11.2 of this manual).
3-78
0931634 - October 2007
REFERENCE MANUAL
Routine use
3.9.1 Deleting patient files - Archives Menu


" Then click Delete Tagged Identities.
"Delete All Tagged Identities?"
" Click
to confirm.
3.9.2 Sorting patient files - Archives Menu


" Then click Sort By Tag: all the tagged files are at the top of the list.
3.10 Test setup
The laboratory has the responsibility for entering the bar codes correctly and for choosing the
appropriate test setup for a given test.
3.10.1 Creating a test setup

" Click the
icon,

3-79
0931634 - October 2007
REFERENCE MANUAL
Routine use
" Click the
button,
" Enter the abbreviation of the new test,

" Click
to confirm,
" If entering parameters is open, enter the information for each parameter,
" If entering parameters is multiple choice, use either:
-
the drop down list (accessible through the
the
the
button),
button,
button,
" Complete the 5 tabs for the test setup,

" Click
to confirm.
3.10.2 Copying a test setup

" Click the
icon,

" Choose the main test to be copied,
" Click the
button,

" Click
to confirm,

" Click
to confirm.
3.10.3 Creating a dependent test

Note: Dependent tests are always displayed in italics.
" Click the
icon,

" Choose the main test from which the test is to be created,
" Click the
button,
3-80
0931634 - October 2007
REFERENCE MANUAL
Routine use
" Click Dependant,

" Changing the dependent test setup,
" Click
to confirm.
3.10.4 Creating a calculated test

Note: A calculated test is the result of a calculation using the result of two primary tests. They should
be based on the same measurement method type.
Calculated tests can not be blocked or rerun.
" Click the
icon,

" Choose the main test from which the calculated test is to be created,
" Click the
button,
The Test creation widow is displayed,

" Type the abbreviation of the copied test,
" Click Calculated,
" Click
to confirm,
" In the Setup tab, Identification part, type the abreviation and the name of the calculated test,
" In the Definition part, select the type of measurement methodology (chronometry, colorimetry
or immunology),
" In the M1 and M2 parts, select the primary tests 1 and 2 (only the tests compatible with the
defined method are displayed in the list),
" Select the calculation formula and choose the coefficient,
" In the Printout/Trans tab, Parameters part, select the transmission rank,
" In the Edition limits part, select the limits (Min. and Max.),
" Click Validate to confirm the addition of this test.
For more information about calculated tests, see chapter 5.11.2.1 of this manual.
3-81
0931634 - October 2007
Routine use
REFERENCE MANUAL
3.10.5 Changing a test setup

You can only change the method type of a primary test involved in a calculated test after you delete
the calculated test.
" Click the
icon,

" Click the
button,

" Click
to confirm.
3.10.6 Updating a test setup

" Click the
icon,

" Click the
button,

Note: If the test is already present in the user database, it is displayed in blue. Otherwise, it is
displayed in grey.
" Click the
" Use the
" Double click the test that is to be updated,

" Click the
icon,
3-82
0931634 - October 2007
REFERENCE MANUAL
Routine use
" Click
The abbreviation as well as the test name is displayed in green, showing that the test has been
" Click the
3.10.7 Updating several test setups

" Click the
icon,

" Click the
button,

" Click the
" Use the
" Double click the tests that are to be updated,

" Click the
icon,
The abbreviation as well as the test names is displayed in green, showing that the tests have been
Changes to the referenced products will be lost.
" Click
3-83
0931634 - October 2007
Routine use
" Click the
REFERENCE MANUAL
3.10.8 Deleting a test setup

Deleting a primary test brings about deletion of all dependent and calculated tests related to it.
" Click the
icon,

" Click the
button,
The message "Do you really want to delete xxx" is displayed,

" Click
to confirm.
3.11 Shutting down STA-R Evolution

3.11.1 Routine shut down
" Click the
icon,
The confirmation window is displayed:
" Click
" Wait until the software is shut down.

" Move the cursor to the bottom of the screen to display the taskbar.
" Click Start, then Turn Off Computer....
3-84
0931634 - October 2007
REFERENCE MANUAL
" Click
Routine use
" Wait for the message "It is now safe to turn off your computer" is displayed.
" Press the screens power supply switch.
" Turn the On/Off switch of the STA-R Evolution to the Off (O) position.
This switch is located on the right side of the STA-R Evolution.
" Press the printers power supply switch.
3.11.2 Prolonged shut down
This procedure is to be followed if the analyzer is to be shut down for more than one week.
regulations in force locally: wearing disposable gloves, a mask and protective goggles.
" Remove all the tubes and the products.

" Remove the bottles (dirty liquid and STA-Cleaner Solution).
" Dispose of the cuvette waste bin and the dirty liquid bottle according to the regulations in force
locally.
" Proceed with decontamination of the analyzer (see procedure in chapter 4.9 of this manual).
Before restarting the analyzer, follow the same decontamination procedure; then put the liquid and
cuvette waste bins back in place.
3-85
0931634 - October 2007
Routine use
REFERENCE MANUAL
3-86
0931634 - October 2007
REFERENCE MANUAL
Content
Maintenance
4.1
Description of the maintenance utility . . . . . . . . . . . . . . . . . . . . . . . . . 1
4.2
Schedule of preventive maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . 2
4.2.1
Schedule of preventive maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
4.3
Daily preventive maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
4.3.1
Checking the condensation trap . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
4.3.2
Cleaning the touch screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
4.3.3
Specific maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
4.4
Weekly preventive maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
4.4.1
Cleaning the main air filter and the optic module case filter . . . . . . . . . . . . . 4
4.4.2
Cleaning the rinsing well and needles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
4.4.3
Cleaning rinsing well N3 and needle N3 with hydrochloric acid . . . . . . . . . 7
4.4.4
Purging the needles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
4.4.5
Purging needles using spray control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
4.4.6
Cleaning the product drawer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
4.4.7
Cleaning the measurement plate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
4.4.8
Cleaning the suction tip . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
4.4.9
Cleaning the conveyor belt (shuttle transporter) . . . . . . . . . . . . . . . . . . . . . 14
4.4.10
Cleaning the shuttles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
4.5
Monthly preventive maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
4.5.1
Changing Teflon tips of the syringes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
4.6
Quarterly preventive maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
4.6.1
Replacing air filters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
4.6.2
Replacing the bar code reader wheel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
.............................................. 1
1
0931634 - October 2007
Content
REFERENCE MANUAL
4.7
Curative maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
4.7.1
Cleaning the racks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
4.7.2
Cleaning the rack conveyor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
4.7.3
Cleaning the Cuvette loader . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
4.7.4
Cleaning the bar code reader wheel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
4.7.5
Cleaning the window of the samples and products bar code readers . . . . . 23
4.8
Replacing components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
4.8.1
Replacing a needle . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
4.8.2
Replacing the suction tip . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
4.8.3
Replacing the lamp . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
4.8.4
Replacing main fuses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
4.8.5
Replacing secondary fuses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
4.9
Decontamination . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
4.9.1
Decontamination procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
4.9.2
Preparation of the decontaminating solution . . . . . . . . . . . . . . . . . . . . . . . . 33
4.9.3
Decontaminating the mandrel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
4.10
Maintenance utilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
4.10.1
Printing the bar codes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
4.10.2
Backing up data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
4.10.3
Restoring of data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
4.10.4
Back-up of results (use of TDex) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
4.10.5
Remote link . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40
4.11
Description of the User Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45
4.11.1
Export CQ . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45
4.11.2
Printing the patient files . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48
4.11.3
Delete lot . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48
4.11.4
Archives Export . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50
4.11.5
Photo. graphics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51
2
0931634 - October 2007
REFERENCE MANUAL
4.11.6
Content
Tracking menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53
3
0931634 - October 2007
Content
REFERENCE MANUAL
4
0931634 - October 2007
REFERENCE MANUAL
Maintenance
4 Maintenance
4.1 Description of the maintenance utility
This maintenance utility allows the user to service the analyzer.

The end user maintenance utility is structured as follows:
4-1
0931634 - October 2007
Maintenance
REFERENCE MANUAL
4.2 Schedule of preventive maintenance

4.2.1 Schedule of preventive maintenance
This schedule is provided for a laboratory that performs approximately 500 tests per day. This
schedule is to be adapted according to the laboratorys test volume.
Frequency
Type of maintenance
Daily
Checking the condensation trap

Cleaning the touch screen
Weekly
Cleaning the main air filter and the optic module

Cleaning the rinsing well and needles
Purging the needles
Cleaning the product drawer
Cleaning the measurement plate
Cleaning the suction tip
Cleaning the conveyor belts
Cleaning the shuttles
Backing up data
Shutting down and restarting the analyzer following the usual
procedure.
Monthly
Replacing the Teflon tips and the O-rings
Quarterly
Replacing the air filters

Replacing the bar code reader wheel
4.3 Daily preventive maintenance

4.3.1 Checking the condensation trap
Purpose: To avoid the presence of liquid in the vacuum pump.
" Click the
icon,
4-2
0931634 - October 2007
REFERENCE MANUAL
Maintenance
regulations in force locally: wearing disposable gloves, mask and safety goggles.
" Check the level of liquid in the condensation trap.

" If liquid is present, the condensation trap is to be drained.
" Unscrew the condensation trap reservoir in the reverse direction shown by the red arrow.
" Dispose of the contents according to the regulations in force locally.
" Put the reservoir back in place.
4.3.2 Cleaning the touch screen

" Click the
icon,

" Use a cloth that has been slightly moistened with ethanol (concentration between 20% and
40%).
" Put your hand on the top of the screen so as to be able to press areas of the screen (touch screen)
strongly using the thumb: this will block the cursor in this position.
" Meanwhile use the cloth to clean the other areas of the screen taking care to avoid streaking.
" Press another area with your thumb to finish cleaning.
4-3
0931634 - October 2007
Maintenance
REFERENCE MANUAL
4.3.3 Specific maintenance

The cap piercing needle requires daily maintenance. For servicing, refer to the procedure set out in
the Cap piercing option manual (ref. 0931239x).
4.4 Weekly preventive maintenance

4.4.1 Cleaning the main air filter and the optic module case filter
Purpose: To avoid internal overheating
" Click the
icon,

" Remove the coarse dirt particles from the filter.

" Rinse the main filter with water and then dry it.
" Put the air filter back in place paying attention to assembly orientation: the arrow must point to
the upper part of the analyzer.
" Remove the air filter from the optic module: open the lower right hand door and pull on the black
cover; vacuum out the dust and then replace the air filter.
The air filter for the optic module may not be washed; if it is damaged, replace it.
4-4
0931634 - October 2007
REFERENCE MANUAL
Maintenance
4.4.2 Cleaning the rinsing well and needles

Purpose: To clean the rinsing well and its tubing to ensure perfect suction and to avoid external
contamination of the needles.
To check the needles and if necessary, unblock them.
If the analyzer is equipped with a cap piercing needle, you need to carry out specific weekly
maintenance; refer to the procedure described in the "Cap piercing option" manual (ref 0931239x).
Note: If white colored deposits appear on the sides of needle N3, you should follow the procedure
in chapter 4.4.3 of this manual for Cleaning rinsing well N3 and needle N3 with hydrochloric acid.
" Click the
icon,

" Click the Rinse Well tab.
The Press the button for rinsing the wells... message is displayed.
" Click the

button,
The messages Home position in progress... and Arm is moving towards the front of the
STA-R are displayed for each arm.
" Click
When arms 1, 2 and 3 are to the front, the message Drawer is going to open, please validate
is displayed.
" Click
,
The drawer opens and the message The drawer is opening, please wait... is displayed.
When it is open, the next message Press OK to continue is displayed.
" Click
,
The message Pour the decontamination solution into each well. When you have finished,
please validate appears.
" Fill each rinsing well to the level with the decontaminating solution (see preparation procedure
in chapter 4.9.2 of this manual).
" Wait 30 minutes during which you can clean the products drawer and the measurement plate.
4-5
0931634 - October 2007
Maintenance
REFERENCE MANUAL
" Meanwhile, put the appropriate mandrel (the metal rod delivered with each new needle) through
each needle.
" Click
,
" Click
,
The drawer closes and the message "Drawer is going to close, please wait..." is displayed.
When it has been closed, the next message "Press OK to continue." is displayed.
" Click
,
" Click
,
The rinsing wells are emptied and the messages "The wells are being emptied, please wait..."
and "Press OK to continue." are displayed.
" Click
,
displayed.
" Click
,
" Click
,
" Click
,
" Click
,
4-6
0931634 - October 2007
REFERENCE MANUAL
Maintenance
" Click
" Click
" Proceed with decontamination of the mandrel:

-
put the mandrel into the decontaminating solution (see preparation procedure in chapter 4.9.2
of this manual),
for the solution to act, leave the mandrel in it for 30 minutes,
remove the mandrel; rinse it and then dry it.

4.4.3 Cleaning rinsing well N3 and needle N3 with hydrochloric acid

Purpose: To clean rinsing well N3 and its supply pipes to ensure perfect suction and to avoid
external contamination of needle N3 if white-colored deposits have appeared on the sides of the
needle.
To check the needle and if necessary, unplug it.
" Click the
icon,

" Click the Well Rin. tab.
The "Press the button for rinsing the wells..." message is displayed.
" Click the

button,
The messages "Home position in progress..." and "Arm is moving towards the front of the
STA-R" are displayed for each arm.
" Click
When arms 1, 2 and 3 are to the front, the message "The drawer is going to open, please
validate" is displayed.
" Click
,
The drawer opens and the message "The drawer is opening, please wait..." is displayed.
When it is open, the extra message "Press OK to continue." is displayed.
4-7
0931634 - October 2007
Maintenance
REFERENCE MANUAL
" Click
,
The message "Pour the decontamination solution into each well. When you have finished,
please validate." appears.
" Fill rinsing well N3 to the level with the 0.1N hydrochloric acid decontaminating solution.
0.1N hydrochloric acid can be produced in the following ways:
-
From 1N (1) hydrochloric acid by dilution to 1/10th, that is 5 ml of 1 N hydrochloric acid and 45
ml of distilled water.
From pure (2) hydrochloric acid said to be smoking - by dilution to 1/100th, that is 0.5 ml of
pure hydrochloric acid and 45 ml of distilled water.
(1)(2) these products are commonly found in laboratories.

" Put an empty STA Microcups with an adaptor in position R2-4.
" Click
,
" Click
,
The drawer closes and the message "Drawer is closing, please wait..." is displayed.
When it is closed, the second message "Press OK to continue." is displayed.
" Open the upper left side door.
" Put needle N3 above the empty STA Microcups and then activate the plunger of the syringe
for needle N3 (point 3 in the figure below) in order to purge the tubes.
You must not remove the plunger from the syringe.
" Raise needle N 3 manually.

" Fill an STA Microcups with the solution of 0.1N hydrochloric acid and put it into the adaptor
in position R2-4.
" Manually insert needle 3 into the 0.1N hydrochloric acid solution that is in the STA-Microcups.
" Draw the solution up into the needle and the connection piece by moving the plunger in the
syringe for needle 3 up and down (see figure below).
" Let it sit for 15 minutes and during this time, move the syringe plunger up and down several times.
4-8
0931634 - October 2007
REFERENCE MANUAL
Maintenance
" After 15 minutes, raise needle 3 manually and remove the 0.1N hydrochloric acid solution as well
as the adaptor.
" Click
,
" Click
,
The rinsing wells are emptied and the message "The wells are being emptied, please wait..."
is displayed.
When emptying has finished, the extra message "Press OK to continue." is displayed.
" Click
,
displayed.
" Click
,
displayed.
displayed.
" Click
,
displayed.
displayed.
" Click
,
displayed.
When rinsing well n3 has been purged, the extra message "Press OK to continue." is displayed.
" Click
,
" Perform the well rinsing operation two more times without decontaminating solution (or purge
needle 3 twice).
" Click
to return to the Maintenance menu.

" Close the upper left side door and then put the tray back in place
" Click the
icon,
time (the check is displayed on the screen).
Note: Maintenance using the hydrochloric acid solution eliminates the need to use the maintenance
procedure with chlorine bleach that used to be carried out.
You should not plan on carrying out both types of rinsing: in other words, chlorine bleach and
hydrochloric acid, because contact between these two solutions may release gas.
4-9
0931634 - October 2007
Maintenance
REFERENCE MANUAL
Using 0.1 N hydrochloric acid in maintenance has no effect on later assays.
4.4.4 Purging the needles

Purpose: A purging procedure for needles in blind tests, for the needle purging procedure using
spray control, see procedure in chapter 4.4.5 of this manual.
" Click the
icon,

" Click the Ndle Purge tab.
" Click the

button, the
or the
The message:
"You have selected number x
" Click
.
The message "Arm is moving towards washing wells and wells are emptied" is displayed,
the needle selected comes into position in the well, and then the extra message "Press OK to
" Click
.
The messages "P-Axis being reset..." then "Press OK to continue." are displayed.
" Click
.
displayed.
" Click
.
The message "Circuit purge in progress. Please wait..." is displayed. The circuit is purged and
then the second message "Press OK to continue." is displayed.
" Click
.
The messages "Home position in progress..." and then "Press OK to continue." are
displayed.
" Click
.
" Click OK
" Click
4-10
0931634 - October 2007
REFERENCE MANUAL
Maintenance
4.4.5 Purging needles using spray control

Purpose: To allow the user to check that the needle is not partially clogged and that the dispensed
volumes are correct.
A purging procedure for needles using spray control; for the blind spray needle purging procedure,
" Click the
icon,

" Click the Ndle purge tab.
" Click Mode Test to display the
" Click the
button, the
symbol.
or the
The message
"You have selected number x. Press OK to continue." is displayed.
" Click
.
The message "Home position in progress...".
displayed.
" Click
.
The message "Arm is moving..." is displayed; the arm moves towards the rinsing well. When the
arm is in position, the extra message "Press OK to continue." is displayed.
" Click
.
The message "You can move the Z-Axis manually" is displayed.
" Click
.
displayed.
" Adjust the height of the arm so that you can see the needle spray clearly; then click
The message "Circuit purge in progress. Please wait..." is displayed.
The circuit is purged; the spray is visible at the needle aperture.
" Check that the spray is straight:

-
that the needle is not clogged. If the spray is not straight, put the mandrel through the needle;
then carry out the test again
or put a graduated tube under the needle so as to check that the dispensed volume is correct;
this volume should be between 3 and 4 ml. If the dispensed. volume is wrong, put the mandrel
through the needle and then carry out a test again; if the problem persists, replace the needle.

A window displaying the message "Do you want more pulses?" appears.
4-11
0931634 - October 2007
Maintenance
REFERENCE MANUAL
" If necessary, click YES; if not, click NO.

If you have chosen NO: The message "Home position in progress..." is displayed.
displayed.
" Click
" Click OK
" Click
4.4.6 Cleaning the product drawer

Unload all the products from the analyzer before cleaning the product drawer (see procedure in
" Click the
icon,

" Check that no needle is left in the product drawer (in one of the positions or in one of the rinsing
wells). If there is a needle, raise it and push it to the back of the analyzer.
" Pull the products drawer open.
" Clean the top with a cloth or paper towel that is slightly moistened with hot water.
Wipe with a dry cloth.
" If a product vial (reagent, control, calibrator, diluent) has been broken, unscrew the captive
thumb screw under the drawer and then pull the card unit slowly upwards so that you can
disconnect the 2 cables. The earth cable (yellow and green) is disconnected by pulling it out; the
flat cable is disconnected by separating the 2 handles. Clean the 2 card unit with the
4-12
0931634 - October 2007
REFERENCE MANUAL
Maintenance
decontaminating solution without getting the cable connections wet. Dry the unit and put it back
in the drawer. Reconnect the 2 cables (push the flat cable to the back so that the handles close)
and screw the thumb screw back on the bottom of the products drawer.
" Push the drawer shut.
4.4.7 Cleaning the measurement plate

" Click the
icon,

" Remove all debris from every measurement cell and from every incubation cell.
" Clean every measurement cell and every incubation cell with cotton swaps slightly moistened
with ethanol (concentration between 20% and 40%). Do not use acetone or trichloroethylene.
" Clean the black cover for the measurement plate with a cloth or paper towel slight moistened
with hot water, and then wipe it with a dry cloth. Do not use ethanol on the measurement plate.
Avoid water overflowing into the measurement and incubation tracks on the measurement plate.

4.4.8 Cleaning the suction tip

Purpose: To avoid accumulation of dirt inside the suction tip and limit grip errors
4-13
0931634 - October 2007
Maintenance
" Click the
REFERENCE MANUAL
icon,

" Place the arm with the suction tip mounted on it to its upper position and bring it to the front of
the analyzer.
" Clean the suction tip with hot water.
" Dry it.
4.4.9 Cleaning the conveyor belt (shuttle transporter)

Purpose: To allow optimal circulation of the shuttles
" Click the
icon,
" Click the Maintenance button to run both shuttle transporter belts.
" Clean both shuttle transporter belts with a cloth slightly moistened with ethanol (concentration
between 20% and 40%).
Do not force the cloth or paper towel under the belt.
Note: If plasma is on the conveyor belt, it should be cleaned using the decontaminating solution.
4-14
0931634 - October 2007
REFERENCE MANUAL
Maintenance
4.4.10 Cleaning the shuttles

Clean the shuttles with ethanol (concentration between 20% and 40%); leave them to dry and put
them back on the analyzer.
4.5 Monthly preventive maintenance

4.5.1 Changing Teflon tips of the syringes
Monthly preventive maintenance
Purpose: To ensure optimal pipetting in each arm and to avoid leaks.
Ref.: 27530 (corresponds to 6 Teflon tips and 6 O-rings)
You should proceed with this change on a monthly basis; however this frequency may not be
adapted to the laboratorys activity. Nonetheless, you will take care not to exceed the limits
managed by the software.
If any syringe is to be replaced, do not use syringes other than those provided by Diagnostica Stago
(Ref.: 27538); this would produce incorrect results.
" Click the
icon,

" Click the Tip/Syringe tab.
The message "Choose a Teflon tip or syringe to replace..." is displayed.
" Click the

button,
The message "You have selected number x
- a new Teflon tip
- or a new syringe" is displayed.
" Take a new tip or a syringe; then click
,
The message "Arm is moving towards washing wells and wells are emptied." is displayed.
" Click
,
The message "P-Axis being reset..." is displayed.
Then the extra message "Press OK to continue." is displayed.
4-15
0931634 - October 2007
Maintenance
REFERENCE MANUAL
" Click
,
The message "You can change the Teflon tip or the syringe according to the procedure
described in the operators manual. When this operation is finished, validate by
pressing OK." is displayed.
" Open the upper left door.
" Unscrew the thumb screw (top of the syringe) on syringe n1. Syringe n1 is on the right.
" Take the syringe out of its clamp.

" Take the plunger out of the syringe.
" Remove the O-ring.
" Remove the Teflon tip with a sharp tool.
" Put the new tip on a flat surface and push the syringe plunger completely into the new tip.
Make sure you keep the tip upright during this operation.
" Insert the Teflon tip into distilled water.

" Draw the plunger back up into the syringe.
" Put the O-ring back in place.
Forgetting to put the O-ring back will lead to incorrect results.
" Put the syringe bottom back into the clamp, making sure you keep the syringe vertical.
" Manually screw the syringe back onto its support, making sure you keep it vertical.
" Put the plunger of the syringe back into upper position.
" Click
,
The message "Reservoir filling in progress..." is displayed; the intermediate STA-Cleaner
Solution reservoir fills up and the second message "Press OK to continue." is displayed.
" Click
,
The message "In order to check the circuit, a purge is performed. Validate by pressing
OK. Press OK to continue." is displayed.
4-16
0931634 - October 2007
REFERENCE MANUAL
Maintenance
" Click
,
The message "Circuit purge in progress. Please wait..." is displayed. The circuit is purged.
Meanwhile, pay attention to the syringe and check for any leaks. When the purge has finished, the
second message "Press OK to continue." is displayed.
" Click
,
The message "Home position in progress..." is displayed; the arm moves to its home position;
then the second message: "Press OK to continue." is displayed.
" Click
,
The message "If a problem occured during circuit purge, please perform the process
again." is displayed.
" Click
,
Return to the screen to choose a tip.
" If necessary, run another purge.
If not, proceed with changing tip n2 and tip n3 by clicking their respective icons,
and by positioning each syringe correctly; see above photo.
" Click
or

4.6 Quarterly preventive maintenance

4.6.1 Replacing air filters
Ref.: 38517, main air filter
Ref.: 38125, optic module filter
" Click the
icon,

4-17
0931634 - October 2007
REFERENCE MANUAL
Maintenance
" Remove the main air filter from the optic module: open the lower right door and pull on the black
cover.
" Throw out the 2 filters.
" Insert the air filters, paying attention to assembly orientation: On the main air filter, the arrow
should be pointing towards the top of the analyzer.
" Exit maintenance by clicking
" Restart the STA-R Evolution.
4.6.2 Replacing the bar code reader wheel

Purpose: Avoid accumulation of dirt. If necessary, the wheel rotates the tubes to ensure that the bar
code reader correctly identifies them.
Ref.: 38698, black tube rotating wheel (x2)
Ref.: 39134, silicon tube rotating wheel (x2)
Ref. 38698
" Click the
Ref. 39134 (silicon wheel)
icon,
4-18
0931634 - October 2007
REFERENCE MANUAL
Maintenance

" Remove the pin manually or using the flat screwdriver in the accessories toolkit; if you use the
screwdriver, put it between the pin and the axle of the tube rotating wheel and use it as a lever:
disengage the pin and pull it gently upwards.
" Remove the cover and then the tube rotating wheel.
Flange
Wheel
Pin
Axle
" Insert another tube rotating wheel.

" Put the cover back in place.
" Insert another pin by hand or using the flat screwdriver.
4-19
0931634 - October 2007
Maintenance
REFERENCE MANUAL
4.7 Curative maintenance

4.7.1 Cleaning the racks
Purpose: To ensure rack cleaning when the racks have been contaminated (plasma...).
" Leave the polypropylene racks that have been loaded to soak in a basin filled with a solution of
detergent and water (for example, a 4.8% solution of sodium hydroxide) for 10 minutes.
" If you use pediatric racks or micro-container racks, do not remove the adaptors when you carry
out cleaning.
Note: If a tube in the rack has been broken, you must decontaminate the rack using decontaminating
solution (see procedure in chapter 4.9.2 of this manual).
You should not use a chlorine bleach solution on a regular basis (except where a tube in the rack has
been broken) or ethanol (concentration between 20% and 40%).
4.7.2 Cleaning the rack conveyor

Purpose: To decontaminate the rack conveyor if a rack is tipped leading to spillage, or if a tube
breaks.
4-20
0931634 - October 2007
REFERENCE MANUAL
Maintenance
" Turn off the STA-R Evolution, see procedure in chapter 3.11.1 of this manual.
" Open the transparent cover as well as the access door to the tube rotating wheel.
" Use the decontaminating solution to clean the rack conveyor, the belts and if necessary the tray.
" Turn the STA-R Evolution back on.
4.7.3 Cleaning the Cuvette loader

Purpose: Restore normal operation of the cuvette loader when cuvettes are stuck in the loader or
broken.
" Click the
icon,
Take up reel
Cuvette feed button
Cuvette loader trap
" Lift the maintenance handle of the take up reel (point n1 in the photo above).
" Remove the take up reel by sliding it along its axis of rotation.
" Open the cuvette loader trap (point n3 in the photo above).
" Lift the maintenance handle for the roll.
" Remove the roll by sliding it along its axle.
" Dispose of any cuvettes or foam in the cuvette loader.
" Put the roll back in place and position it so the roll is on the left and the take up reel is on the right.
" Slide the roll along its axis of rotation and lower the rolls maintenance handle.
" Slide the take up reel along its axis of rotation and lower the take up reels maintenance handle.
" Put the film into the cuvette loader so that it is parallel to the loading rails.
4-21
0931634 - October 2007
Maintenance
REFERENCE MANUAL
" Close the cuvette loader trap.
Do not twist the film.
" Press the button beside the take up reel (point n2 in the photo above) to start feeding the
cuvettes.
" Check whether the cuvettes enter the cuvette loader without twisting sideways, and keep
pressing the feed button until the cuvettes have been completely inserted into the loader.
4.7.4 Cleaning the bar code reader wheel

Purpose: To restore correct operation of the wheel if there is an accumulation of dirt (e.g. ink, glue).
" Click the
icon.

" Open the access door to the tube rotating wheel.
" Remove the clip manually or using the flat screwdriver in the accessories toolkit. If you use the
screwdriver, put it between the clip and the axle of the tube rotating wheel and use it as a lever.
" Remove the flange and then the tube rotating wheel.
4-22
0931634 - October 2007
REFERENCE MANUAL
Flange
Wheel
Clip
Axle
Maintenance
" Carefully clean the wheel using a soft cloth moistened with ethanol (concentration between 20%
and 40%).
" Put the wheel, the cover and finally the clip back into place.
" Close the access door for the bar code reader.
4.7.5 Cleaning the window of the samples and products bar code readers
Purpose: Restore the correct operation of the samples and products bar code readers if bar codes
are not being read.
" Take a cotton swap and moisten it with ethanol (concentration between 20% and 40%).
" Carefully clean the bar code reader window.
4-23
0931634 - October 2007
REFERENCE MANUAL
Maintenance
4.8 Replacing components

4.8.1 Replacing a needle
If the analyzer is equipped with a plug piercing needle, replacing the needle requires carrying out a
specific servicing procedure; refer to the procedure described in the Cap piercing option manual
(ref 0931239x).
Ref.: 39249 (for the standard n1 needle)

" Click the
icon,

" Click the Ndle Repl tab.
The message "Choose a needle to replace..." is displayed.
" Click the
button, the
or the
button depending on which needle is to be replaced.
The message "You have selected number x.

- a new needle
- the mapping cuvette" is displayed. x corresponds to the number of the needle to be changed.
" Take a new needle that has a reference that matches the needle that is to be changed and the
mapping cuvette (this is provided with the analyzer); then click

Arm n1 (n2 or n3) moves to its home position; then when it is finished, the second message
"Press OK to continue." is displayed.
" Click
The message "Arm is moving..." is displayed; the arm moves towards the front of the analyzer.
When the arm is in position, the extra message "Press OK to continue." is displayed.
" Click
and validate by pressing OK." is displayed.
4-24
0931634 - October 2007
REFERENCE MANUAL
Maintenance
" Open the products drawer manually.
regulations in force locally: wearing disposable gloves and disposal procedure (see below).
Removing the needle n1 and the needle n2

" On the lower level of the needle bearing unit, completely unscrew the knurled nut.
" Remove this nut.
Legend:
Needle
Knurled nut
" Unscrew the connection a rotation (or at most a rotation).
" Disconnect the connecting tubing.

" Lower the needle-tubing unit.
" Remove the needle-tubing unit.
4-25
0931634 - October 2007
REFERENCE MANUAL
Maintenance
Reassembly of the needle n1 and the needle n2
" Push the needle tube into the tubing so that it abuts this tube.
" Check that the tubing is not caught in the needle tube.
" Insert the tubing in the sheathing in the chain and set it along its path.
" Reconnect the tubing to the connection and screw it back on.
Removing the needle n3
Do not disconnect the tubing on the upper level of the head.
" Completely unscrew the knurled nut on the lower level of the needle tube.
" Remove this nut.
" Lower the needle until the heating tube appears.
" Disconnect the needle-tubing from the heating tube.
Reassembly the needle n3
" Push the heating tube into the needle tubing so that it abuts this tube.
Reassembly of needle n3
" Push tthe needle tube into the needle tubing so that it abuts this tube.
4-26
0931634 - October 2007
REFERENCE MANUAL
Maintenance

Checks to be performed independently of needle type
" Check the position of the tubing and the cables on the upper level to avoid hindering arm
movement.
" Check the connection of the level detection cable from the point where it comes out of the
needle tube to the electronic card.
" Remove the metal mandrel from the needle and keep it to clean or unclog the needle.
" Put the mapping cuvette in a shuttle at the sample station (needle n1) or at the reagent station
(needle n2) or in the measurement cell (needle n3).
" Close the products drawer manually.
" Click
and validate by pressing OK." and then "Autodetection not active" are displayed.
" Click

Arm n1 (n2 or n3) moves to its home position; then when it is finished, the extra message
"Continue... Press OK to continue." is displayed.
" Click
The message "Setting of the mapping position:

- Adjust X and Y with the arrow buttons
- Manually adjust Z
Continue..." is displayed.
" Manually lower the specific needle tube to see if the needle can penetrate the hole in the mapping
cuvette. If necessary, click one or more arrows until the needle can freely penetrate the hole in
the mapping cuvette. Then insert the needle right to the bottom of the central hole in the
mapping cuvette.
" Click
The message "Continue..." is displayed.

" Click
The messages "Z being recalculated", "X being recalculated" and "Y being recalculated"
are displayed one after the other and then disappear.
" Click
" The message "Press OK to continue." is displayed.

" Click
" The message "The procedure was successful." is displayed.

" Click OK
4-27
0931634 - October 2007
REFERENCE MANUAL
Maintenance
Return to the choice of the needle that has to be changed.

" Lift the transparent cover
" Recover the mapping cuvette.
" Close the transparent cover
" Run a purge on the needle that has been changed.
" Click

4.8.2 Replacing the suction tip

Ref.: 39163 (delivered in sets of 2)
" Click the
icon,

" Click the Suction tab.
The message "Press the suction tip button..." is displayed.
" Click the
button.
The message "For this operation, you must have;

- a new suction tip
" Take another suction tip; then click

The suction tip arm auto-zeroes; then when it is finished, the next message "Press OK to
" Click
The message "Arm is moving towards the front of the STA-R" is displayed; the arm moves
to the front of the analyzer.
" Remove the suction tip by pulling it down.
4-28
0931634 - October 2007
REFERENCE MANUAL
Maintenance
" Dispose of the suction tip and the gloves used to remove the suction tip. Use new gloves to insert
the new suction tip.
" Put the new suction tip in soapy water (to facilitate its insertion), dry it and insert it: it should abut
the suction tip support.
" Dry the suction tip.
" Click
The message "You have replaced the suction tip. Please close the cover in order to run
automatic tests." is displayed.
" Close the transparent cover and click
The message "Home position in progress..." is displayed. The suction tip arm moves to its
home position; then when it is finished, an additional message "Press OK to continue." is
displayed.
" Click
" Click
4.8.3 Replacing the lamp

Ref.: 26699, Halogen Lamp
" Click the
icon,

" Click the Lamp tab.
The message "Press the lamp replacement button..." is displayed.
" Click the
button.
The message "For this operation, you must have:

- a new halogen lamp
" Take another lamp; then click
" The message "When you have replaced the lamp, please validate in order to perform a
photometric test." is displayed.
" Open the lower right door.
The lamp stand as well as the lamp may still be hot; let them cool off.
" Unscrew the thumb screw by hand to be able to remove the small flap.
4-29
0931634 - October 2007
Maintenance
REFERENCE MANUAL
" Lower the lamp stand, pushing back the tubing if necessary.
" Hold the lamp stand down. Remove the used lamp from its stand with the other hand, protecting
it with a piece of paper of a dry cloth to avoid burns or possible injury.
" Take the new lamp.
Do not touch the new lamp directly; use a piece of paper or a dry cloth.
" Lower the lamp stand, pushing back the tubing with one hand if necessary. Hold it down. Place
the new lamp in its holder with your other hand.
" Gently release the lamp stand
" Put the flap back in place.
" Put the thumb screw back on.
" Click
The photometry test is run. Meanwhile, the message "Lamp Test in progress, please wait..."
is displayed.
When the test is finished, the second message "Press OK to continue." is displayed.
" Click
The message "Halogen Lamp OK" is displayed.

" Click
4.8.4 Replacing main fuses

Ref.: 26681 - 6.3 A T 5x20 (set of 10 delayed 6.3A fuses for the STA-R Evolution 230V)
Ref.: 26694 - 15 A T 6.3x32 (set of 10 delayed 15 A fuses for the STA-R Evolution 100/115V)
This operation should be done with the analyzer turned off.
The main fuses are located in two compartments above the On/Off switch to the right of the STA-R
Evolution.
4-30
0931634 - October 2007
REFERENCE MANUAL
Maintenance

" Unplug the mains cable.
" Put a screwdriver into the gap in the fuse housing; unscrew the housing completely (in the
direction indicated by the arrow, from right to left); the housing will disengage.
" Remove and replace each fuse with a fuse of the same amperage: 6.3A for the STA-R Evolution
230V or 15A for the STA-R Evolution 100/115V, read the references carefully; see above.
" Put each fuses housing back in place and screw them in completely (opposite direction to that
indicated by the arrow, from left to right).
" Plug the mains cable in again (check that the switch is turned to Off).
4.8.5 Replacing secondary fuses
STA-R Evolution 115V / 100V
STA-R Evolution 230V
Reference
Set of 10 fuses
Reference
Set of 10 fuses
39880
1 A T 5x20
39880
1 A T 5x20
26682
2 A T 5x20
26682
2 A T 5x20
26684
5 A T 5x20
26684
5 A T 5x20
26681
6,3 A T 5x20
26681
6,3 A T 5x20
39863
10 A T 5x20
26694
15 A T 6.3x32
26694
15 A T 6.3x32
4-31
0931634 - October 2007
Maintenance
REFERENCE MANUAL
The 15 A fuse is larger than the other fuses and has a different aspect.
This operation should be done with the device turned off.
The secondary fuses can be found by opening the lower left door of the STA-R Evolution.
LED on: the fuse is operational
LED off: the fuse needs to be changed.

" Open the lower left door.
" Put a screwdriver into the aperture of the housing for the fuse to be changed; press strongly and
turn the screwdriver a quarter circle in the direction of the arrow (from right to left): the fuse
housing is disengaged.
" Remove and replace each fuse with a fuse of the same amperage: The fuse values are given beside
their housings; see photo above (pay careful attention to references; see above).
" Put the fuse housing back in place by pressing strongly and turning in the opposite direction to
the one the arrow indicates (from left to right).
" Close the lower left door.
4-32
0931634 - October 2007
REFERENCE MANUAL
Maintenance
4.9 Decontamination
4.9.1 Decontamination procedure
Note: In accordance with the recommendations of the S.F.R.L. (Syndicat des Fabricants de Ractifs
de Laboratoire: Societe of Manufacturers of Laboratory Reagents) relative to people who work in
contact with biological products that may present risks (biohazards), you must proceed with
decontamination of the STA-R Evolution system, following the procedure described above, prior
to any intervention by a representative (in particular by an After-Sales Service technician) or by a
transporter designated either by Diagnostica Stago, or by one of their official distributors.
Decontaminate the following parts:
-
The products drawer,
The measurement plate,
The rinsing wells,
The conveyor belts,
The rack conveyor,
The needles,
The mandrel.
4.9.2 Preparation of the decontaminating solution

Chlorine bleach is usually merchandised as follows:
-
Chlorine bleach in a 1 litre container with 2.6% active chlorine,
Extract of chlorine bleach in 250 ml single serving packages with 9.6% active chlorine.
The 9.6% solution must first be diluted to , that is 1 part of 9.6% bleach to 3 parts of water to
obtain a 2.6% chlorine bleach solution.
" Mix 1 part 2.6% chlorine bleach with 6 parts water. This gives 2.6% chlorine bleach diluted to 1/
7 that is 0.37% chlorine in the end.
4.9.3 Decontaminating the mandrel

" Put the mandrel into the decontaminating solution.
" For the solution to act, leave the mandrel in it for 30 minutes,
" Remove the mandrel; rinse it and then dry it.
4-33
0931634 - October 2007
REFERENCE MANUAL
Maintenance
4.10 Maintenance utilities
Diagnostica Stago is not liable in case of contamination and/or users hardware or software
dysfunction resulting for example from the use of floppy disks or any other material, and more
particularly during savings and/or data files transmission, such as the ones described of this manual.
4.10.1 Printing the bar codes

Purpose: To print a page of bar codes from the STA-R Evolution, that is 65 bar code labels.
-
Type of bar code printed: 2 out of 5 interlaced
Type of label recommended: 7810 (3 M)

- acrylic adhesive, matte white polyester support
- cutting the label: rounded ends to avoid lifting.
" Click the
icon,
" Click the
button.
" Enter the first number in the bar code (Beginning of the series).
" Enter the number of pages of bar codes to be printed.
" Enter the incremental value of the bar code.
Note: The Number of Digits area is automatically updated from the incremental value of the bar
code.
" Check printer setup using the
" Click the
button; change setup if necessary.
icon,
Printing a page of bar codes.

" Click the
button.
Note: Before sticking the label on the tube, make sure that:
-
the tube is clean,
the manufacturing date of the label to be glued is less than 1 year ago,
the label should be applied perpendicular to the axis of the tube and the figures should read from
bottom to top,
if there is already a label on the tube, the new label should completely hide the bar code on the
old label.
4-34
0931634 - October 2007
REFERENCE MANUAL
Maintenance
4.10.2 Backing up data

Purpose: enable the user to save:
- the test methodologies as well as the calibrations and the associated quality controls,
- the error messages,
- the archives relating to the patient (results, identities,).
Note: The system settings will be backed up systematically.
This back-up operation may last a long time.
" Click the
icon,
" Click the
button.
" Click either the checkbox or the description of the item to select the items to be backed up.
" Select the storage medium:
-
Back-up on CD/DVD

4.10.2.1 Backing up data on diskettes

The number of diskettes required for the back-up is indicated.
" Click the
button.
The following messages are displayed:

"Info about this Backup executed at:
Date/Time"
ATTENTION!! Use a pre-formatted blank floppy disk
Number of blank disks expected: x "
" Insert an unused, formatted diskette and click
to confirm.
The following message is displayed when the diskette is full:

then Click on Ok".
" Insert a diskette into the drive.
4-35
0931634 - October 2007
Maintenance
" Click
REFERENCE MANUAL
to confirm.
" Wait until the message "Backup is complete." is displayed.

" Click
to confirm.
" Remove the diskette from the drive and write down the following information:
Back-up Diskette DK/NbDK
STA-R Evolution Nxxxx
software version: y.yy
date"
where:
- DK is the diskette number,
- NbDK is the number of diskettes used for this back-up,
- xxxx the serial number of the analyzer.
- y.yy the main software version of the analyzer
" Click the
button.
Note: Work with 2 sets of back-up diskettes: one used in even numbered weeks, the other in odd
numbered weeks.
4.10.2.2 Backing up data on CD/DVD

" Click

Info about this Backup executed at:
xx/xx/xx xx:xx
" Click

" Click
to confirm.

The data is saved in the STABCK.zip file and in the EntetelD.txt file.
This data is located in D:\BackUpRestore\yyyy-mm-dd-hh-mm.
Write the main software version on the CD/DVD and the serial number of the analyzer.
Do not use this CD/DVD on another analyzer or with another software version.
4.10.3 Restoring of data

Purpose: enable the user to restore data from diskette:
4-36
0931634 - October 2007
REFERENCE MANUAL
Maintenance
the test methodologies as well as the calibrations and the associated quality controls,
the error messages,
the archives,
the system settings,
This restoring operation writes over the data in the selected files on the hard drive.
" Click the
icon,
" Click the
button.
" Click the Restore tab.

" Select the type of storage medium:
-
Restoring data from diskettes
Restoring data from CD/DVD
" Insert the medium to be restored.
Make sure that the serial number and the software version on the back-up diskette are identical to
the ones on the analyzer.
Restoring data from diskettes:
" Click

Insert the last floppy disk of set
" Insert in the driver the first diskette of the last back up to restore and click
to confirm.
4-37
0931634 - October 2007
REFERENCE MANUAL
Maintenance
-
Restoring data from CD/DVD:

The CD/DVD structure tree is displayed: the BackUpRestore folder is open.
The folders which might be restored appear, they are identified by the date and the
hour of their back-up.
" Double-click the file to restore.
" Click the
button that has appeared.
Only check the System configuration item if the hotline advises you to do so.
" Select the items to be backed up by clicking either the checkbox or the description of the item
and then click
to confirm.
If the Test configuration item is selected, the following message is displayed:

"Caution: This operation will erase the patients, product files and replace the current
test set up, calibrations and controls on board STAR.
Do you agree?"
If the Archives item is selected, the following message is displayed:
"Caution: This operation will erase the current archive file on board STAR.
Do you agree?"
If the System configuration item is selected, the following message is displayed:
"Caution: This operation will replace the current mapping, printing and transmission
parameters on board STAR.
Do you agree?"
" Click
to confirm each message; otherwise click
The data is restored and the following confirmation message is displayed:

"Restore complete".
" Click
to confirm.
" Remove the diskette, the CD or the DVD from the drive.
" Click the
button.
4.10.4 Back-up of results (use of TDex)

Purpose: To allow the user to back up the patient results, the associated calibrations as well as the
information related to the products used.
4-38
0931634 - October 2007
REFERENCE MANUAL
Maintenance
Note: The database allows you to back up the data for 600 patients. The patients who have been
deleted are not backed up by TDex. To back them up, you only need to reload them on board and
all the data on a given patient will be re-entered in the database and can be backed up.
The file on back-up diskette is a text file (.txt) that can be read by other applications (e.g. Excel).
" Click the
icon,
" Click the
button.

-
Back-up on CD/DVD

4.10.4.1 Backing up results on diskettes

" Enter the new name for the file.

Creating a FILE NAME.txt file that may be read and used in other applications.
Note: If there isn't a diskette in the drive, click Open another file.
" Click Save.
The Comments window appears.
" Enter the comments if necessary, and then click OK.
Note: You can enter 5 lines of comments, which can include up to 75 characters per line (including
spaces).
" Click the
button.
4.10.4.2 Backing up results on CD/DVD

" Click the
button.
The Comments window is displayed.

" Enter the comments if necessary, then click OK.
Note: You can type 5 lines of comments, each line may contain up to 75 characters (75 characters
including spaces).
" Click
4-39
0931634 - October 2007
REFERENCE MANUAL
Maintenance

" Click
to confirm.

The data are saved in a file called ddmmyyyy.txt.
This file is located in D:\TDEX\yyyy-mm-dd-hh-mm.
" Click the
button.
4.10.5 Remote link

Purpose: To allow the hotline to carry out telemaintenance operations.
This procedure is only possible if PC Anywhere is installed and should only be carried out at the
request of your telephone support.
At any time and from any menu that you are in, you can run the PC Anywhere utility; to do this:
" Simultaneously press the following keys: Ctrl + Alt +F5
The connection will be established.
You can also make the connection by following the procedure below:
" Click the
icon,
" Click the
button.
" Double click the STA-R icon.
4-40
0931634 - October 2007
REFERENCE MANUAL
Maintenance
The Maintenance screen appears again. From then on, the hotline can be connected to the
analyzer to carry out telemaintenance operations.
You should make this connection secure either:
-
by turning on the MODEM only when necessary,
by protecting access to your analyzer with a password defined in PC Anywhere,
by combining both security procedures described above.
4.10.5.1 Define or change a password in PC Anywhere

Purpose: To secure your analyzers remote connection.
" Click START in the taskbar (at the bottom of the screen).
(If the taskbar does not appear on the screen, simultaneously press Ctrl + Alt + B to display it.)
" Click Programs, pcAnywhere and then Symantec pcAnywhere.
" Using the right button of your mouse, click the STA-R button.
" Click Properties.
4-41
0931634 - October 2007
Maintenance
REFERENCE MANUAL
" Click the Callers tab.


" Click Properties.
4-42
0931634 - October 2007
REFERENCE MANUAL
Maintenance
" Enter the callers identification (in the Login Name text box) and the password (in the Password
text box).
" Cick
to confirm.
To define a password through the STAR Maintenance utility, follow the procedure below:
" Click the
icon,
" Click the
button.
" Click the STA-R button and then right click under the Touchpad.
" Select Properties
4-43
0931427D - October 2007
Maintenance
" Click the
REFERENCE MANUAL
tab

" Click Properties.
4-44
0931634 - October 2007
REFERENCE MANUAL
Maintenance
key.
key.
4.11 Description of the User Menu
4.11.1 Export CQ
4.11.1.1 Export the quality controls

" Click the Export CQ button.
4-45
0931634 - October 2007
REFERENCE MANUAL
Maintenance
" Click the Export Excel tab.

" Back-up on CD/DVD
" Back-up on diskette
" Insert the medium.
" Click the Select Date Range button.
" Select the period you want using the

" Click
and
arrows.
" If necessary, enter a date range.

" Check the Check All Test checkbox or select the required methodologies using Windows multiselection (Ctrl + mouse or
+ mouse).

A window that indicates the number of entries found appears:
4-46
0931634 - October 2007
REFERENCE MANUAL
" Click
-
Maintenance
to confirm.
Back-up on diskette:
" Click
The data is saved directly on the diskette with Excel format.

Note: By clicking the Other tab, the last exported file may be displayed.
-
Back-up on CD/DVD:
" Click

" Click

A progression window is displayed
" Click
The data is saved in a file called ddmmyyyy.txt.
This file is located in D:\ExportCQs\yyyy-mm-dd-hh-mm.
Note: By clicking Other, the last exported file may be displayed.
The data will be saved directly on the diskette in Excel format.
Note: When you click the Other tab, you view the last file exported.
4.11.1.2 View all the quality controls in the database

When you click the CQ Results tab, you can view all the data in the database related to the quality
controls.
4-47
0931634 - October 2007
REFERENCE MANUAL
Maintenance
4.11.1.3 Deleting quality controls

You can purge the database for a given period of time.
" Click the Delete tab.
" Click the Select Date Range button and use the arrows to select the period of time you want.
The number of saves that can be deleted is displayed.
" Confirm the deletion by clicking
4.11.2 Printing the patient files

The Customized Printout button allows you to customize printing an archived or on board patient
files (see procedure in chapter 3.7.11.3 of this manual).
4.11.3 Delete lot

" Click the Delete Lot button,
4-48
0931634 - October 2007
REFERENCE MANUAL
Maintenance
" Click the number of the lot to be deleted,

" Click the Delete this lot button,

" The message
"Confirm delete lot n
and calibrations" is displayed,
" Click
The lot number is deleted from the list.

" Click
4-49
0931634 - October 2007
Maintenance
REFERENCE MANUAL
4.11.4 Archives Export

" Click the Archives Export button.
" Click Files and then Open.

" Select the file containing the archived data to be viewed.
" Select the period to be viewed.
" Select the test(s) to be viewed.
" Click the GO button,
The data are displayed from selected criteria.
" Select the destination to which to export the .xls file containing the archives displayed on the
screen:
-
Exportation on diskette, see the rest of the procedure in chapter 4.10.4.1
Exportation on CD/DVD, see the rest of the procedure in chapter 4.10.4.2

" Click Files and then Export on Floppy/HD.
" Select 31/2 Floppy (A:) in the pull-down menu.
" Type a name for the file.
4-50
0931634 - October 2007
REFERENCE MANUAL
Maintenance
" Click

" Insert a CD-R, CD-RW or DVD-R.
" Click Files then Export on CD/DVD.
" Enter a name for the file in the Filename field then click

" Click

" Click

The data is saved in a file called tdexarch.xls.
This file is located in D:\TDexArchive\yyyy-mm-dd-hh-mm.
" Click
4.11.5 Photo. graphics

" Click the Photo. Graphics button,
The following screen is displayed:
4-51
0931634 - October 2007
Maintenance
REFERENCE MANUAL
" Choose the test to be displayed,

" Click the Measure 1 or Measure 2 button,
4-52
0931634 - October 2007
REFERENCE MANUAL
Maintenance
" Click
to print the graphic.
" Click
to return to the measurements list.
4.11.6 Tracking menu

Note: the files older than 365 days are automatically deleted from the tracking file.
" Click the Tracking Menu button,
" Select the records to be displayed (by period and/or module).

" Select how to display the data:
-
chronological order
anti-chronological order
" Click the Export button to export the data,
4-53
0931634 - October 2007
REFERENCE MANUAL
Maintenance
The following screen appears (only if the analyzer is equipped with a CD/DVD recorder):
" Select the data display format:

-
series separated by commas
Excel table with column headings
" Select the destination for the data to be exported:

-
Exportation on diskette
Exportation on CD/DVD


The message Insert a formated disk nx is displayed.
to confirm.
" The message Export procedure stopped is displayed.

" The data are saved in the "BackupDate".txt file.

" Insert the CD-R, CD-RW or DVD-R.
4-54
0931634 - October 2007
REFERENCE MANUAL
" Click
Maintenance

" Click

The message "Export procedure terminate on D:\Tracking\aaaa-mm-jj hh-mm" is
displayed
" Click
The data is saved in a file called "BackupDate".txt.

This file is located in D:\Tracking\yyyy-mm-dd-hh-mm.
4-55
0931634 - October 2007
Maintenance
REFERENCE MANUAL
4-56
0931634 - October 2007
REFERENCE MANUAL
Content
Detailed description of the software screens
5.1
How to read a screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
5.1.1
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
5.1.2
Function panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
5.1.3
System panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
5.1.4
System panel Icon list . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
5.1.5
General contents of a screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
5.1.6
Contents of a screen First line . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
5.1.7
Contents of a screen Selection tab . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
5.1.8
Contents of a screen Displaying a partially visible tab . . . . . . . . . . . . . . . . . 4
5.1.9
Contents of a screen Scroll bars . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
5.1.10
Contents of a screen Vertical scroll bar . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
5.1.11
Contents of a screen Horizontal scroll bar . . . . . . . . . . . . . . . . . . . . . . . . . 5
5.2
How to use a screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
5.2.1
Navigating through the software . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
5.2.2
Moving a column . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
5.2.3
Printing a screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
5.3
Display and use of the online help . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
5.3.1
Display the online help . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
5.3.2
Use the online help . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
5.4
Test Panel screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
5.4.1
Description of the Test Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
5.4.2
Horizontal scroll bar Control panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
5.4.3
Vertical scroll bar Control panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
5.4.4
Displaying additional information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
5.4.5
Displaying the list of patient files . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
5.4.6
Display modes for the patient file columns . . . . . . . . . . . . . . . . . . . . . . . . . 11
5.4.7
Displaying results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
............ 1
1
0931634 - October 2007
Content
REFERENCE MANUAL
5.4.8
Archives button Test Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
5.4.9
Search Button Test Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
5.4.10
Color codes on results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
5.4.11
Patient file identification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
5.4.12
File marker Test Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
5.4.13
Modalities for displaying results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
5.4.14
Rack number . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
5.4.15
Symbols used for the patient files in the Test Panel . . . . . . . . . . . . . . . . . . . 18
5.4.16
Symbols used for the tests in the Test Panel . . . . . . . . . . . . . . . . . . . . . . . . 18
5.5
Sample loading screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
5.5.1
Sample (Un)Loading screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
5.5.2
State of the tray . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
5.5.3
List of known racks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
5.6
Patient Acquisition . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
5.6.1
Patient Acquisition screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
5.6.2
Complete identification of a patient file . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
5.6.3
Test selection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
5.7
Product loading screens . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
5.7.1
Loading screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
5.7.2
List of products screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
5.7.3
Forecast screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
5.7.4
Drawer screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
5.7.5
Barcode label reading window . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
5.8
Calibration screens . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
5.8.1
General information about calibrations . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
5.8.2
Calibration curve . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
5.8.3
Test list Calibration screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
5.8.4
Products tab Calibration screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
2
0931634 - October 2007
REFERENCE MANUAL
Content
5.8.5
Table of points tab Calibration screen . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
5.9
Quality control screens . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
5.9.1
General principles for quality controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
5.9.2
Quality Control screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40
5.9.3
List of possible functions Quality Control screen . . . . . . . . . . . . . . . . . . . 41
5.9.4
Test list Quality Control screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
5.9.5
Information on the level of the quality control . . . . . . . . . . . . . . . . . . . . . . . 42
5.9.6
Definition of the terms used Quality Control screen . . . . . . . . . . . . . . . . 43
5.9.7
Graphical displays . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
5.9.8
Numeric information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
5.10
Patient File screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50
5.10.1
Patient File screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50
5.10.2
Writing a note . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51
5.10.3
Dates - Patient File screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51
5.10.4
Limits - Patient File screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51
5.10.5
Raw measurement - Patient File screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51
5.10.6
Status of the results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52
5.10.7
Test/Result/Status Patient File screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52
5.11
Test setup screens . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52
5.11.1
General information on the test configurations . . . . . . . . . . . . . . . . . . . . . . 52
5.11.2
Methodology tab Test setup screens . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54
5.11.3
Results tab - Test setup screens . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60
5.11.4
Calibration tab Test setup screens . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68
5.11.5
Printout/Transmission tab - Test setup screens . . . . . . . . . . . . . . . . . . . . . . 74
5.11.6
Quality Controls tab - Test Setup screens . . . . . . . . . . . . . . . . . . . . . . . . . . 76
5.12
Global Options screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79
5.12.1
Global Options screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79
5.12.2
Titles 1 and 2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79
3
0931634 - October 2007
Content
REFERENCE MANUAL
5.12.3
Languages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 80
5.12.4
File Entry: Parameter for patient file acquisition . . . . . . . . . . . . . . . . . . . . . 80
5.12.5
Miscellaneous . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81
5.12.6
Arbitrary Units . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 82
5.13
Communications screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 83
5.13.1
Communications screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 83
5.13.2
The number of trials should there be an error . . . . . . . . . . . . . . . . . . . . . . 84
5.13.3
Station number . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 84
5.13.4
Protocol type . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 84
5.13.5
Transforming the character . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 84
5.14
Passwords screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 85
5.15
Status - Counters screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 86
5.15.1
Temperatures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 86
5.15.2
Level detection management . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 86
5.15.3
Versions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 87
5.15.4
STAR serial number . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 87
5.15.5
Timer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 87
5.15.6
Suction pad . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 87
5.15.7
Availability before maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 87
5.15.8
Cuvettes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 87
5.15.9
Cleaner Solution . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 88
5.16
CD/DVD recorder screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 88
4
0931634 - October 2007
REFERENCE MANUAL

screens
5 Detailed description of the software screens

5.1 How to read a screen
5.1.1 Introduction
All the screens of the STA-R Evolution are displayed in the same way.
5-1
0931634 - October 2007

screens
REFERENCE MANUAL
5.1.2 Function panel

The function panel is always displayed at the top of the screen.
Clicking an icon displays the corresponding menu:
Display the screen for righthanded or left-handed users
displays the Patient menu
displays the Products menu
displays the Calibration

menu
displays the Quality Control

menu
displays the Setup menu
displays the contextual help
displays the STAT menu
displays the Maintenance

menu
5.1.3 System panel

The system panel is always displayed at the bottom of the screen.
Clicking an icon displays the function that corresponds to it:
At the bottom left, the software version number is displayed with patch identification if need be.
In the left window, information on the system is displayed:
-
the number of racks on board,
the number of tubes on board,
the number of cuvettes available on the reel.
The current date and time are displayed on the right part of the screen.
5-2
0931634 - October 2007
REFERENCE MANUAL

screens
5.1.4 System panel Icon list

or is erroneous

or is erroneous

a test is blocked due to lack of
product (reagent, control or
calibrator)

(insufficient Desorb, manual
blocking of samples etc.)

because of lack of calibration

the photometric tests are
blocked because of detection
of an error in photometry
restart the analyzer
emergency shutdown
exit system
printing
displays the control screen

(cuvette counter,
temperatures, level detection
etc.)
5.1.5 General contents of a screen

Aside from the function panel and the system panel, which are always displayed at the top and the
bottom of the screen, the central area of the screen changes depending on the menu selected.
The principles behind consulting data are the same for all screens.
The data specific to each screen is described in the sections dealing with the screen.
5.1.6 Contents of a screen First line

Identification of the currently displayed menu.
This menu has been selected using one of the icons in the function panel.
5-3
0931634 - October 2007

screens
REFERENCE MANUAL
5.1.7 Contents of a screen Selection tab

Clicking the name of a tab provides access to a sub-menu.
5.1.8 Contents of a screen Displaying a partially visible tab
Click on the arrow to completely display the tab.
5.1.9 Contents of a screen Scroll bars

Using the scroll bars, you can move through the list of displayed elements:
-
upwards or downwards, vertical scroll bar,
to the right or to the left, horizontal scroll bar.
5.1.10 Contents of a screen Vertical scroll bar
moves cursor one notch up
moves cursor to the desired location
displays the following screen
moves cursor one notch down
5-4
0931634 - October 2007
REFERENCE MANUAL

screens
5.1.11 Contents of a screen Horizontal scroll bar
moves the cursor one notch to the left
moves the cursor to the desired location
moves the cursor one notch to the right
5.2 How to use a screen

5.2.1 Navigating through the software
To find out how to navigate through the software and access the various screens (loading, calibration
etc.), click the buttons and the elements that correspond to them.
" Click the buttons displayed on the screen by pressing the touch screen with your finger or using
the pointer provided for this purpose.
Note: Do not use any other object to click an element on the screen.
5.2.2 Moving a column

" Access the screen you want by clicking one of the icons in the function panel and then clicking the
appropriate tab.
" Touch the header of the column to be moved.
" Maintain pressure on the header while moving it to the position where you want it to be.
5.2.3 Printing a screen

You can print the displayed screen or save it as an image using the Print Screen key.
" Simultaneously press Ctrl + Alt + X
The system management icons appears at the top of the screen.
5-5
0931634 - October 2007

screens
REFERENCE MANUAL
The
button allows you to display the window displaying the software versions of the system
(Windows XP, Internet Explorer and main software).
The
system.
check box allows you to display the task manager window of the WindowsXP
The Print Screen drop down box allows you to choose the destination for the screen copy.
To Printer: The screen is printed on paper.

This option is activated by default when the analyzer starts.
To File: The screen is saved to the file: C:\STAPLUS\SCREEN.

The name automatically attributed to the image corresponds to the time and date when it is
saved.
The viewing area for the contents of the C:\STAPLUS\SCREEN files allows you to view (using a
double click) or to delete (using the Delete Selection button) the images in this file.
To Floppy: The screen is saved to a diskette.

The name automatically attributed corresponds to the time and date when the image is saved. It
may be changed.
Warning: Make sure there is enough space in the floppy disk before saving.
No action: Touching the Esc key leads to no other action (whether saving or printing).
" Scroll through the Print Screen dropdown list box and click the destination for the screen copy.
" Press the Print Screen key.
5-6
0931634 - October 2007
REFERENCE MANUAL

screens
5.3 Display and use of the online help

The online help allows the quick display of useful information while using with the analyzer.
5.3.1 Display the online help

The online help may appear on the users request anytime and regardless of the menu currently
displayed.
" Click
The cursor
appears.
" Click the screen area for which the contextual help is required.
If there is a contextual help for that area, it appears on the screen.
5.3.2 Use the online help

The online help window is made up of one main part, on the right side of the screen, used for the
display of the requested information. The left side of the screen is made up of tabs including:
The Contents tab:
" From the Contents tab, click the icon (+) located on the left side in order to unroll the sections
of the chapter.
" Click the section that needs to be displayed.
The content of this section appears on the right side of the screen.
The Search tab:
" In the text box, type a word or sentence in relation with the request (a character or a character
string may be replaced by a *).
The chapters where the requested words or sentences appear are displayed on the left side of
the screen.
" Click a chapter to display its content on the right side of the screen.
The Favorites tab:
" In the text box of Current topic, type the name you wish to give to the topic currently displayed
on the screen.
" Click Add.
The name of the topic appears in Topics and the Display and Delete buttons become activated.
These topics thus saved in the favorites, may afterwards be either displayed (Display) or removed
(Delete).
5-7
0931634 - October 2007
REFERENCE MANUAL

screens
5.4 Test Panel screen

5.4.1 Description of the Test Panel
The Test Panel screen allows you to track test progress in real time for all the records whose sample
tubes are loaded or are waiting to be loaded.
It is accessed by clicking the
icon and then the Test Panel tab.
You can simultaneously open up to 10 records.

You will see several functional areas:
-
Display of complementary information for a records,

Display of the list of patient files,
The result display area,
The
button allows you to look for one or more files,
The
button allows you to suspend sampling,
The
button allows you to resume sampling,
The
button allows you to suspend transmission,
The
button allows you to resume transmission,
The
button allows you to access the archives,
5-8
0931634 - October 2007
REFERENCE MANUAL

screens
The
button allows you to manually identify the tubes when they are loaded,
The
reader,
button allows you to identify the tubes when they are loaded using the bar code
The
button allows you to automatically unload the rack if a tube is not read in order to
identify the tube manually,
The
button allows you to tag (or untag) records,
The vertical scroll bar,
The horizontal scroll bar.
Clicking the heading of the T column offers the possibility of:

-
Sorting by tag,
Tagging everything,
Removing all tagged items,
Transmitting the tagged files,
Download the tagged files,
Validating the tagged files,
Apply a profile to the tagged files,
Deleting the tagged files,
Display or mask the Rack, Po (position) and Sts (status).
5.4.2 Horizontal scroll bar Control panel

Using the horizontal scroll bar in the Test Panel, you can move to the right or the left in the test list.
By clicking the arrow pointing right, you move one step to the right in the test list The test displayed
By clicking the arrow pointing left, you move one step to the left in the test list The test displayed
By selecting the scroll box, you move to the area you want in the test list.
5.4.3 Vertical scroll bar Control panel

Using the vertical scroll bar in the Test Panel, you can move upwards or downwards in the patient
file list.
By clicking the arrow pointing downwards, you move the cursor a step downwards.
By clicking the arrow pointing upwards, you move the cursor a step upwards.
By selecting the scroll box, you move the cursor to the area you want in the list of dossiers.
5-9
0931634 - October 2007
REFERENCE MANUAL

screens
5.4.4 Displaying additional information

In the Test Panel, additional information (possibly name, first name, etc.) is displayed for the patient
record where the cursor is located.
The selection of the contents of additional information is defined in the Global Options screen, see
procedure in chapter 5.12 of this manual.
5.4.5 Displaying the list of patient files

The list of patient files is displayed in the form of a table in this area of the Test Panel.
A patient file, a calibrator or a control corresponds to each line in the table. The calibrators and the
controls are only displayed during their processing (from the moment they are run to the moment
the results are obtained).
Each file is identified by a checkmark (
symbol), its identification, its rack number, its position in
the rack and its specificities (for example, urgency and/or micro-volume). The icon
enables you
to visualize the identities presenting at least one result with analarm. This information is organized in
a column.
A rack and a position displayed in green indicate a pediatric tube loaded in a pediatric rack.
A rack and a position displayed in blue indicate a microcontainer tube loaded with a blue rack
intended for microcontainers.
By double clicking a patient identification, you display all the details in the patient file; see procedure
in chapter 5.10 of this manual.
By clicking the column headings, you sort the files.
A heading displayed in white means that the patient files are displayed in an order that corresponds
to the sort carried out according to this criterion (on this heading).
The T, Identity, Rack, Po (Position in the rack), Sts (specificities of the dossier) may be displayed in
the order that the operator wants to display them; see procedure in chapter 5.2.2 of this manual.
5-10
0931634 - October 2007
REFERENCE MANUAL
Clicking the

screens
button allows you to classify the patient files in the following order:
white
(validated files)
blue
yellow
(files in progress)
red
(erroneous files)
grey
(empty files)
Cursor position is highlighted in blue.
5.4.6 Display modes for the patient file columns

You can mask the Rack and/or Position and/or Status columns in the patient identity table.
" Click the T column heading.
-
the |T| Identity | option allows you to mask all the Rack, Po and Sts columns automatically
The Rack option allows you to mask the Rack column
The Po option allows you to mask the Position column
The Sts option allows you to mask the Status column
The columns may be displayed in the order chosen by the user, see procedure in chapter 5.2.2 of this
manual.
5.4.7 Displaying results

In this area of the Test Panel, the results of the tests for the patient files listed alongside are
displayed. To each column a test is associated.
In the column heading, you find the abbreviation for the test, the unit chosen to display the results,
the letter D, which indicates that the tests were performed twice, the symbol for the calculated
tests and if the test is a dependent test, it is displayed in italics.
The events in progress are represented by symbols.
Double clicking an empty checkbox allows you to add a test to a patient file.
Double clicking a result displays the list of possibilities: deleting the result(s), rerunning the
measurement(s), transmitting the result(s), viewing the result(s) as a grph (photometry tests).
Clicking once on the abbreviation for a test (column heading) displays the window of operations that
may be carried out on previously tagged files for this test: adding the test, blocking the test,
unblocking the test, rerunning the 1 or 2 measurements, deleting the test, transmitting the test,
validating the test or choosing the modalities for displaying the results:
-
choosing the unit for displaying the result for the test performed,
for the tests performed twice, the possibility of displaying both results obtained or of displaying
the average.
5-11
0931634 - October 2007

screens
REFERENCE MANUAL
You can also move the test columns to display the tests in the order that you desire; see procedure
in chapter 5.2.2 of this manual.
The re-diluted tests are presented on a yellow background (with the exception of a test in progress
).
5.4.7.1 Description of the result display in single determination
The final result is the last measurement obtained after the reruns and redulitions that might have
been required.
In single determination, the result displayed in the test panel is the final result.
-
If there is an error in the final result: this error is displayed
If there is no error in the final result: the displayed result depends on the unit chosen by the user
for control panel display, see table below.
If there is no error in the final result:

Displayed unit
Raw unit
Unpeaked raw measurement
Main unit
Peaked and converted into main unit measurement if the result is

outside the editing limits
Secondary unit 1

Secondary unit 2

Secondary unit 3

5-12
0931634 - October 2007
REFERENCE MANUAL

screens
5.4.7.2 Description of the result display in duplicate determination
The final restult is the last measurement obtained after the reruns and redulitions that might
have been required.
In duplicate determination, the result displayed in the test panel depends on the final result of the first
determination (D1) and of the final result of the second determination (D2):
-
if D1 and D2 have the same error (insufficient quantity of plasma, technical error, linearity error,
M<MMin, M>MMax):
this error is displayed ("QNS", "Error", "Linearity", "V<VMin", "V>VMax")
if D1 and D2 have different errors:

if D1 or D2 is not in error whereas the other determination is:

if D1 and D2 are not in error:

the displayed result depends on the result display options chosen by the user:
type of unit (raw unit, main unit or secondary unit 1, 2 or 3) and display of both results or of their
mean value, see table.
If the final D1 result and the final D2 result are not in errror
Display
unit

if display of both units
if display of the mean value
Raw unit
Unpeaked raw determination 1

and
unpeaked raw determination 2
Unpeaked raw mean
Main unit

unpeaked
and
unpeaked
Mean calculated in main unit and

peaked
Secondary unit 1
Not applicable

Secondary unit 2
Not applicable

Secondary unit 3
Not applicable

5-13
0931634 - October 2007

screens
REFERENCE MANUAL
5.4.8 Archives button Test Panel

The Archives menu allows you to view all the files for which the tubes have been unloaded from the
STA-R Evolution.
The test statuses are associated with an identity in this menu.
When a tube for which the tests were in waiting is reloaded, the results of the tests performed
previously are restored and the analyses for the tests in progress are run.
Note: By default, only the current days archives are displayed.
The archives file can hold up to 5000 files; the organizational principle of this file is: 1st in, 1st out.
button allows you to access the Archives menu. This offers the possibility of:
Clicking the
-
Sorting by mark,
Marking everything,
Removing all markings,
Deleting the marked files,
Transmitting the marked files,
Validating the marked files,
Printing the marked files.
5.4.9 Search Button Test Panel

Clicking the
button provides the possibility of looking for a patient file.
" Click Search by.

to the first complementary information, or click Date).
" Click Search.
" Click
to confirm.
5.4.10 Color codes on results

Color codes are used to show results presenting an anomaly. As soon as a result presents an anomaly,
an alarm
appears near the patient identity.
5-14
0931634 - October 2007
REFERENCE MANUAL

screens
Test rerun, for example after a technical error (missing ball etc.) or because of
detection of a time period less than the min. time (<Vmin) or greater than the
max. time (>Vmax)
Test started again because of a problem in detection of level
V>Vmax
For the chronometric tests: raw measurement greater than the max. time defined
in the test setup, or if the linear extrapolation is desactivated: raw measurement
greater than the max. time in the calibration.
V<Vmin
For the chronometric tests: raw measurement less than the min. time defined in
the test setup, or if the linear extrapolation is desactivated: raw measurement less
than the min. time in the calibration.
Error
Technical error
Lin.
Insufficient linearity for the colorimetric or immunological tests
QNS
Quantity of plasma Not Sufficient
5-15
0931634 - October 2007

screens
REFERENCE MANUAL
5.4.11 Patient file identification

Patient file ID numbers are 16 alphanumeric characters at most.
Color codes accompany identification when it is necessary to bring out certain elements:
validated patient file
patient file with at least one test in

progress
patient file with at least one

erroneous test
patient file with at least one test to

be validated
patient file with empty work list
download request carried out for

this patient file
patient file transmitted with no

prior downloading request (this
symbol appears only in the details
of the patient file)
manually identified or re-identified

patient file
patient file with at least one test

presenting an anomaly
Printed patient file (or in the print

queue)
In the Test Panel, a single triangle (the priority bearing one) is displayed. The orders of priority are
defined as follows, from the most important to the least important priority:
-
yellow
(files in progress)
red
(erroneous files)
blue
white
(validated files)
grey
(empty files)
In the Patient File screen from the moment when at least one test in the file has as a status: in
progress, erroneous, to be validated or validated, the corresponding triangle is displayed. In this way,
you can total the 4 codes for a file including at least 4 tests: yellow (in progress), red (erroneous),
blue (to be validated) and white (validated).
In the specific cases of calibrators or controls, identification is composed of several elements:
-
The dilution used, only for the calibrators
The calibration number (calibrators) or the number for the control level (controls)
Example:
-
12350-20-1 STA -Unicalibrator, dilution used = 1/20, calibration n1
12354-1
STA -System Control N, first level of control
5-16
0931634 - October 2007
REFERENCE MANUAL

screens
5.4.12 File marker Test Panel

Clicking the
button tags the file which the cursor is on, or removes the tag if this file was already
tagged. Then, the cursor goes down a step.
You can also tag a file by clicking in the T column in front of the file to be tagged,
The
sign appears in the T column for all the tagged files.
5.4.13 Modalities for displaying results

In the Test Panel, the results are displayed in the unit selected by the operator; see procedure in
When the analyses have been carried out twice, you can choose to see both measurements or only
the average.
The analyses that have been carried out twice are identified by the letter D beside the unit.
For the photometric tests (colorimetric and immunological) the result(s) can be viewed as a graph;
see procedure in chapter 3.7.7.2 of this manual).
5.4.14 Rack number

6 alphanumeric characters at most.
In the specific case of calibrators and controls, this number is replaced by the position of the vial in
the products drawer, that is R0-xx. (R0: left area of the drawer and xx number for the position).
If there is a wait for the sample tube for a patient file to be loaded, the
the place of the rack number.
symbol appears in
A rack number displayed in blue indicates that it is a blue rack intended for microcontainers. The
microcontainer status is then automatically affected to the patient in the Patient Acquisition screen.
5-17
0931634 - October 2007

screens
REFERENCE MANUAL
5.4.15 Symbols used for the patient files in the Test Panel
The following symbols show the specificities of each patient file: They are displayed in the Sts (status)
column.
Stat patient file
Sample tube loaded into a microcontainer or a pediatric tube
Stat patient file with sample tube

loaded into a micro-container or a
pediatric tube

a calibrator

a quality control
Printed patient file (or one in the

printing queue)
5.4.16 Symbols used for the tests in the Test Panel

cuvette

reagent(s)
progress
progress (405 nm)
progress (540 nm)

product
Test requested for a patient file

with sample tube waiting to be
loaded
5-18
0931634 - October 2007
REFERENCE MANUAL

screens
5.5 Sample loading screen

5.5.1 Sample (Un)Loading screen
By means of this screen, you can view the identities of the racks present inside the analyzer. For each
rack, you can find out how many sample tubes are loaded and what their identities are. In this way,
you can tag the racks with a view to their unloading.
This screen can be accessed by clicking the
The list of the racks known to the analyzer appears on one side of the screen, and the state of the
tray appears on the other side. The list of the identities for the rack that you have pointed to appears
in the middle.
5-19
0931634 - October 2007
REFERENCE MANUAL

screens
The following functions are also available from this screen:

-
Automatic profile adding
Downloading
Removing the tray
Unloading tagged racks
Reload the rack(s) present on the tray
Printing the list of racks on board

on the screen above)
(appears in the status bar at the bottom right, invisible
When you click Identities in Rack the following functions appear:

-
Initialize the rack conveyor
Enter the repeatability
number
5.5.2 State of the tray

Color coding allows you to identify the state of the tray.

The racks in the tray are represented graphically. Cursor position is highlighted in blue.
Color code
Meaning
Green frame
The tray may be removed.
5-20
0931634 - October 2007
REFERENCE MANUAL

screens
Red frame
Frame in red with an exclamation mark
Determination of the number of racks to be

loaded into the analyzer in progress.

pointing downwards
Loading racks from the tray to the analyzer in

progress.

pointing upwards
Unloading racks from the analyzer to the tray in

progress.
Grey frame
Tray missing
5-21
0931634 - October 2007

screens
REFERENCE MANUAL
5.5.3 List of known racks

The list of racks known to the analyzer is displayed in the form of a table in the (Un)Loading area
of the screen
Each line in the table corresponds to a rack that is identified by the tag it may have (
number and its status.
Status and number
symbol), its
Meaning
and number of the rack displayed in white

and number of the rack displayed in yellow
and number of the rack displayed in grey
Rack that has been unloaded and that is in

the tray
Rack with at least one tube with tests in
progress
When you click the column headings, you carry out sorts on the racks; see procedure in chapter 5.4.5
of this manual.
The columns T (rack tagged), Rack and Status may be displayed in the order that the operator
desires; see procedure in chapter 5.2.2 of this manual.
Cursor position is highlighted in blue. For the racks that are in the tray, the rack that corresponds to
the cursor position is also highlighted in blue in the graph that represents the tray.
5-22
0931634 - October 2007
REFERENCE MANUAL

screens
5.6 Patient Acquisition

5.6.1 Patient Acquisition screen
This menu allows you to create patient files without loading the corresponding tubes; the tubes will
be loaded later and the test list will be automatically added.
The creation of a new patient file is done by clicking the
icon.
You can also create or change the test list for the existing patient file (add a test or a test profile)
whether the tubes are present or not. The test profiles are defined in this screen; see procedure in
Changing an existing patient file is done by clicking the
icon.
Part of this screen is reserved for the complete identification of the patient file and the other for test
selection.
5.6.2 Complete identification of a patient file

In this area of the Patient Acquisition screen, you find the information related to the complete
identification of a patient file with:
-
Identification,
The complementary information (possibly name, first name, etc.). The coherence of the contents
of the complementary information is defined in the Global Options screen, see procedure in
chapter 5.12 of this manual.
5-23
0931634 - October 2007
REFERENCE MANUAL

screens
-
The rack number,
The position in the rack,
The notion of urgency (
Loading to micro-container or pediatric tube (
displayed),
displayed),
For the calibrators and the calibration controls, the
symbol is displayed and for the quality
controls
. The calibrators and the controls are only displayed during their processing (from
running them to obtaining the result).
The
icon provides access to the change in the patient file either in complete identification or
in test selection.
In the specific case of a patient file with unloaded tube, the
the rack number.
symbol is displayed in the place of
5.6.3 Test selection

This part of the Patient Acquisition screen allows you to select tests either individually or by using
profiles.
The individual tests to be selected are displayed in a list.
The previously selected tests are identified by a red triangle
selected are identified by a green triangle
; the tests in the course of being
The Profile nx or Automatic buttons allow you to apply the corresponding test profile to the
patient file.
The
button provides access to the definition of various profiles and to changing them.
5-24
0931634 - October 2007
REFERENCE MANUAL

screens
5.7 Product loading screens

5.7.1 Loading screen
5.7.1.1 Open screen
The Open screen is similar to the List of products screen below. The 3 main differences are:
-
The displaying of a window at the bottom of the screen for identification of products to be loaded,
The disappearance of information relating to the cleaning solution (STA-Cleaner Solution) and
to the cuvettes,
The
icon allows you to display the list of missing products (it only displays on the screen
when a product is missing).
Note: The LEDs next to the vial flash for products that are no longer valid in terms of stability and/
or expiration date and/or volume. As far as volume is concerned, the end of the vial means that the
volume left is less than or equal to the minimum volume.
5-25
0931634 - October 2007

screens
REFERENCE MANUAL
5.7.2 List of products screen
5.7.2.1 List of products screen
The List of products screen brings together all the products loaded in the analyzer.
icon and then the List of products tab.
You have the contents of the products drawer: reagents, diluents, decontaminating solution
(STA-Desorb U), calibrators and controls and on the other hand, the quantities available for the
cleaning solution (STA-Cleaner Solution) and the cuvettes.
For each product, you have its identification number, its name, its type, its position in the drawer,
its lot number, its theoretical stability, its end of use and the volume that is available.
When you double click the product, you display the information that has been identified from the bar
code.
This information is displayed in the form of a table with one line per product and a column for each
piece of information. The columns can be displayed in the order desired by the operator; see
When a product is not useable (the barcode sheet was not read or no calibration has been required
for the lot) or is no longer useable (insufficient volume, stability exceeded, problem in level
detection), the whole line of information is displayed in gray.
To see a graphic representation of the drawer, click the Drawer tab. The cursor position is kept then.
5-26
0931634 - October 2007
REFERENCE MANUAL

screens
5.7.2.2 List of Missing Products Screen
The List of missing products screen (see chapter 5.7.1.1 of this manual) brings together all the
products required to perform the work load and which are not yet in the products drawer.
For each missing product, you have:
-
the area of the drawer in which it should be loaded,
the product identity,
the product name,
the number of loaded vials / the number of vials required.
5.7.2.3 End of use for the loaded products

List of products screen: expiration time and date for each product loaded in the products drawer.
Drawer screen: expiration time and date for the selected product.
To calculate the expiration time and date, the software adds the stability defined in the Test Setup
screens to the time and date when the product was loaded.
A yellow triangle
is displayed one hour before the products end of use.
A red triangle
is displayed when the end of use is exceeded. In this case, the whole line of
information is displayed in gray.
The
5.7.2.4 Name of loaded products

List of products screen: name of each product loaded in the products drawer.
Drawer screen: name of the selected product.
A red triangle
means that the product is not useable (the barcode sheet was not read or no
calibration was required for the lot) or is no longer useable (insufficient volume, stability or problem
in level detection). In this case, the whole line of information is displayed in gray.
5-27
0931634 - October 2007
REFERENCE MANUAL

screens
A yellow triangle
means that the product will soon no longer be useable (volume close to the
lower limit and/or stability soon exceeded).
A green triangle
is useable without restriction.
5.7.2.5 Lot number of the loaded products

List of products screen: lot number of each product loaded in the products drawer.
Drawer screen: lot number of the selected product.
A red triangle
means:
that the bar code sheet corresponding to this lot was never read (the
the lot number),
or that no calibration was ever required for this lot.
icon is displayed beside
In this case, the whole line of information is displayed in gray.

The lot number 999999 corresponds to the products for which the lot number is not assigned.
5.7.2.6 Identification number of the loaded products

List of products screen: identification number of each product loaded in the products drawer.
Drawer screen: identification number of the selected product.
The
stir symbol appears beside the identification number for the products that need to be
stirred by a magnetic stir bar.
detection), the identification number as well as the whole line of information related to the product
is displayed in gray.
5.7.2.7 Position of loaded products

List of products screen: position of each product loaded in the products drawer.
Drawer screen: position of the selected product.
Each position is identified by an RX-xx coding.
RX corresponds to the areas in the drawer and xx to the position number in the area.
RX
Area
Type of products
R0
Left
5-28
0931634 - October 2007
REFERENCE MANUAL

screens
R1
Central

R2
Right
Reagents to be distributed after the first incubation

(mainly start reagents), decontaminating solution
The
letter symbol appears for the positions requiring stirring by magnetic stirrer.
The
symbol (List of products screen) or
(Drawer screen) appears beside the position of
the products loaded without positive identification.
gray.
5.7.2.8 Stability of loaded products

List of products screen: theoretical stability of each product loaded in the products drawer.
Drawer screen: theoretical stability of each selected product.
This stability is defined in the Test setup screens.
gray.
5.7.2.9 Type of loaded products

List of products screen: type of each product loaded in the products drawer.
Drawer screen: type of the selected product.
Type of product
Abbreviation used in the

List of products screen
Title used in the Drawer

screen
Diluent
Dilu.
Diluent
Decontaminating solution
(STA-Desorb U)
Clean.
Cleaner
Reagent
Reag.
Reagent
Control
Ctrl.
Control
Calibrator
Cal.
Calibrator
Unknown product
Non identified
Non identified
5-29
0931634 - October 2007

screens
REFERENCE MANUAL
detection), the type as well as the whole line of information related to the product is displayed in gray.
5.7.2.10 Volume on board for loaded products

List of products screen: volume actually available for each product loaded in the products drawer.
Drawer screen: volume actually available for the selected product.
The Volume On Board corresponds to the volume of the vial without taking into account the
minimum volume.
The Minimum Volume is defined in the Test setup screens. When the product has been decanted
into an STA -Microcups, the minimum volume equal to 200 l is automatically updated; the
letter symbol is then displayed.
A yellow triangle
is displayed when the volume on board is equal to or less than 20%.
A red triangle
is displayed when the minimum volume is reached (volume on board = 0) or when
a problem in level detection has been detected. In this case, the whole line of information is displayed
in gray.
5.7.3 Forecast screen
5.7.3.1 Forecast screen
Provisional administration is performed in real time. The contents of the screen are re-updated every
time the racks are loaded as well as every time the products drawer is closed.
5-30
0931634 - October 2007
REFERENCE MANUAL

screens
The Forecast screen is automatically displayed for 15 seconds if a product to carry out the work load
is going to be missing. The analyses are blocked then in order to allow the operator to intervene.
The Forecast screen brings together all the products (diluents, controls, calibrators, reagents,
decontaminating solution, cleaner) as well as the number of cuvettes required to perform either all
the tests (default display).
The state of the analyses for all the tests (default display) is also shown.
icon and then the Forecast tab.
This information related to each product is displayed in the form of a table with one line per product
and a column for each piece of information.
Consequently you have:
-
The product loading area,
The identification number of the product,
The product name,
The margin.
When a product is missing or present but not useable (calibration not performed), the margin is
displayed in red.
You can print the list of missing products (the number of vials required to perform the analyses is
indicated) using the
icon.
5.7.3.2 State of the analyses Forecast screen

Number of analyses according to their state for the selected test(s):
Total
Number of analyses in waiting

sample tube is waiting to be
loaded
Number of analyses blocked by

the user



measurements are in progress
Total number of analyses

(= sum of 6 others)
The analyses concern the sample tubes, the controls and the calibrators.
The estimated end of work is re-updated in real time at every change in work load.
5-31
0931634 - October 2007
REFERENCE MANUAL

screens
5.7.3.3 Loading area Forecast screen

For the products required for running the selected and already loaded test(s), R. area of the products
drawer in which the product has been loaded.
For the missing products, area in which the product is expected.
R.
Area
Type of products
R0
Left
R1
Central

R2
Right
Reagents to be distributed after the first incubation (mainly

releasing reagents), decontaminating solution
5.7.3.4 Identification of the products Forecast screen

Identification number (ID) for each loaded product as well as for each product waiting for the running
of the selected test(s).
5.7.3.5 Name of the products Forecast screen

Name of each product required for running of the selected test(s).
5.7.3.6 Product margin Forecast screen

The margin for each product required for running of the selected test(s) is the quantity of product
that will be left after running of the requested test(s) (this quantity takes into account the minimum
volume of the vial).
Margin administration is performed in real time. The margin is updated every time the racks are
loaded as well as every time the products drawer is closed.
A green triangle
means that nothing is to be reported for this product: the margin once the work
load carried out is positive.
A red triangle
means that the product is missing or not useable (stability exceeded, insufficient
volume or absence of calibration for this batch).
The samples are blocked and the
5-32
0931634 - October 2007
REFERENCE MANUAL
If controls or calibrators are missing, the

screens
5.7.4 Drawer screen
5.7.4.1 Drawer screen
In the Drawer screen, you can see on the one side a graphic representation of the products drawer
and on the other side, all the characteristics of the vial that has been selected.
5.7.4.2 Characteristics of the selected vial

For the selected vial (represented on the screen by a
are displayed:
symbol), all the characteristics of this vial
Its position in the products drawer; the area is indicated in a light shading,
Its identification number,
Its name,
Its type,
Its lot number,
Its loading time and date,
Its theoretical stability,
Its utilization time and date,

5-33
0931634 - October 2007
REFERENCE MANUAL

screens
-
Its on board volume,
Its volume minimum (defined in the Test Setup screens).
5.7.4.3 Graphic representation of the products drawer

The products drawer is represented in the form of a graph with colors that allow you to identify the
status of each product.
Unoccupied position.
Occupied position, vial with no problems.
Occupied position, vial near the end of stability or volume.
Occupied position, vial unused (insufficient volume or stability exceeded).
Stirring position.
Position currently selected by the cursor. The information displayed on the left of
the screen corresponds to this position.
The blue circle
identification.
indicates that the product has been loaded without positive
The
letter symbol appears beside the position for the products that were
loaded without positive identification.
e.g.: R0-24
Cursor position.
5.7.5 Barcode label reading window

The Barcode label reading window appears:
-
at loading time for a reagent with a new lot number,
after you double click a line concerning a reagent for which the
the lot number (List of products screen, drawer closed).
symbol is displayed beside
5-34
0931634 - October 2007
REFERENCE MANUAL
Note: The red symbol

5.7.2.5 of this manual.

screens
may have 2 meanings; see Lot number of loaded products in chapter
Before the bar code sheet is read, only the partial lot number and the product identification are
displayed. After the sheet is read: the product box reference number, the expiration date and the
complete lot number appear.
When you click Please pass label in front of barcode reader, you display a window in which you
may scan the bar code sheet under the bar code reader if the bar code has not been read properly;
5.8 Calibration screens

5.8.1 General information about calibrations
The calibrations can be run from the Calibration menu (accessed by the
running procedure in chapter 3.8.1 of this manual).
icon, see this
You can use two calibrations for the same test.

The Calibration screen is divided into 3 parts:
-
an area to display the calibration curve,
an area to display either the list of products that have been used to perform the calibration, or a
table of calibration points,
a section to display the test list.
5.8.2 Calibration curve

Calibration screen
The selected calibration curve is displayed with:
-
The theoretical concentrations along the X-axis,
The measurements along the Y-axis,
The time and date of the validation of the calibration,
The equation for the calibration curve,
The regression coefficient,
The value of the ISI (International Sensitivity Index) coefficient. This only appears if the INR
(International Normalized Ratio) unit has been chosen.
For the Raw and Ratio calibration modes, there is no calibration curve. In the Ratio calibration
mode, the reference time is displayed in this area of the screen.
Each calibrator is represented by a blue point. The point, which is marked by two dotted lines
representing its coordinates on the X-axis and on the Y-axis, corresponds to the calibrator on which
the cursor is located in the table of points.
5-35
0931634 - October 2007

screens
REFERENCE MANUAL
5.8.3 Test list Calibration screen
5.8.3.1 Test list Calibration screen

bar.
For each test, you can have two colored triangles. In this way, you can identify the status of the
calibrations for each test at a glance.
The choice of one of the two calibrations possible for each test is made by clicking
the first calibration and
to display
to view the second one.
Double clicking the test abbreviation gives you access to the functions possible for the calibrations
connected to this test:
-
Rerun the calibration,
Calibrate,
Canceling a calibration in progress,
Deleting a calibration,
Modifying the100% Pt,
Changing the reference time and the ISI value,
Validate on the basis of the regression coefficient (validation R. coef.).
5.8.3.2 Meaning of the colored triangles

Calibration screen - Test list
Each test is associated with two colored triangles that give the state of the two calibrations in this test:
A single
triangle
There is only one calibration associated with this test.

First validated calibration.
Second validated calibration.
First calibration in progress.
Second calibration in progress.
5-36
0931634 - October 2007
REFERENCE MANUAL

screens
First calibration not performed or erroneous

Second calibration erroneous
First calibration to be validated.
Second calibration to be validated.
5.8.4 Products tab Calibration screen
5.8.4.1 Products tab

Calibration screen
List of products that have been used to perform calibration with reagents.
To view the information related to each reagent, you only need to click the corresponding button
(Ra, Rb, Rc or Rd).

Calibration screen Calibration Pts. tab
You can extend the points table by 3 extra columns that contain information related to each
calibrator:
" Double click inside the table
" Select Calibrators List
ID
Product identification number of the calibrator used in the calibration.
Name
Complete name of the calibrator used in the calibration.
Lot
Lot number corresponding to the calibrator used in the calibration.
Information identical to that displayed on the line above.
The name of the test and the calibration mode are displayed under the calibration points table.
5-37
0931634 - October 2007

screens
REFERENCE MANUAL

Calibration screen Products tab Reagents area
ID
Product identification number of the selected reagent (Ra, Rb, Rc or Rd).
Name
Complete name of the selected reagent (Ra, Rb, Rc or Rd).
Lot
Lot number corresponding to the reagent used in the calibration.

Note: For the client products, entering the batch number is indispensable (1
digit minimum).
Ra, Rb, Rc correspond to the intermediary reagents; Rd to the start reagent.
5.8.5 Table of points tab Calibration screen
5.8.5.1 Table of Points tab

Calibration screen
Display of some elements of calibration in the form of a table.
The available data is:
-
Calibrators,
Measurements,
Interpolated results.
By double clicking one of the lines in the table (one of the calibrators), you can rerun, change or
delete the calibration point.
By double clicking in the table once and then selecting Calibrators List, the information related to
the calibrators (ID, Name and lot number) is displayed.
When you place the cursor on a line in the table, you automatically see the marker for the
corresponding calibrator on the curve. This marking is seen through two dotted lines that extend
from the point and intersect the X and Y-axes.
The calibration mode (Linear, 2nd order polynomial, 3rd order polynomial, Hyperbola, Raw,
Ratio) is provided at the bottom of the points table. The pre-calibrations are identified by the
symbol, which is displayed as wells as the mode.
For the calibration modes: Raw and Ratio, only the indication of calibration mode is provided.
5-38
0931634 - October 2007
REFERENCE MANUAL

screens
5.8.5.2 Theoretical concentration of the calibrators

Calibration screen Table of Points tab
Calibrators = theoretical concentration of the calibrators in the main result unit. For the precalibrations, viewing points as defined in the Test setup screens.
When a calibrator required for running of a calibration is not in the Products drawer at running time,
the
symbol is displayed for the theoretical calibration.
The
5.8.5.3 Raw measurements for the calibrators

Calibration screen Table of Points tab Meas. Column
When the calibration has been run, each event is represented in the Meas. Column by a symbol:
processed

cuvette

reagent(s)
progress
progress (405 nm)
progress (540 nm)

product
Concentration thresholds not

entered for a calibrator
Calibrator missing or present in

the drawer but with a bar code
that has not been read
As the results and the raw measurements in the calibration are obtained, they are displayed in the
Meas. column:
-
for coagulation analyses, coagulation time measured in seconds,
for colorimetric and immunological analyses in .D.O or in D.O./min.
Error messages are used to show results presenting an anomaly:
Error
Technical error.
5-39
0931634 - October 2007

screens
REFERENCE MANUAL
M>MMax
For the chronometric tests, raw measurement greater than the max. time defined
in the test setup.
M<MMin
For the chronometric tests, raw measurement less than the min.. time defined in
the test setup.
Lin.
Insufficient linearity for the colorimetric or immunological tests.

Problem in level detection.
For the pre-calibrations, raw values recalculated from the equation for the curve (read by bar code)
and from the viewing points defined in the Test setup screens.
5.8.5.4 Interpolated results for the calibrators

Calibration screen Table of Points tab Interpol. Column
Values of calibrators calculated after interpolation from the equation found for the calibration curve
(in the main result producing unit).
For the pre-calibrations, no value is indicated (unused column).
5.9 Quality control screens

5.9.1 General principles for quality controls
The quality controls are loaded in area R0 in the products drawer.
For each new lot number, the threshold values for the quality controls of the STA line are read using
bar code sheets found in each box of controls. For the other controls, the threshold values must be
entered manually.
For Diagnostica Stago controls, the threshold values are correctly attributed in the appropriate test
if the main unit selected for them is the same as the one defined on the stickers on each box of
controls (except for Fibrinogen; for the main unit g/l, the values will be correctly attributed even if
they are given in mg/dl on the sticker).
The quality controls for a given test are automatically run by the STA-R Evolution as soon as it is to
carry out an analysis corresponding to this test and when one of its criteria for running QC that was
defined in the Test setup screens has been met. This criterion may be the time, the number of tests
or a change of vial (only if the vial is on board).
The quality controls can also be run manually; see procedure in chapter 3.5.1 of this manual.
The quality controls are run either once or twice according to the determination type selected for
the sample. When they are run twice, each result is considered to be an individual result.
5-40
0931634 - October 2007
REFERENCE MANUAL

screens
If the result of the quality control is outside of the acceptance range, all the patient results for the test
in question will be accompanied by an alert message: "Quality control: out of range or not done".
If the operator decides to accept the results of a quality control that has been declared to be nonstandard, all the patient results for the test in question will be accompanied by an alert message:
"Quality control: forced validation".
The exploitation of quality controls is based on the Levy-Jennings statistical model.
i=n
xi
Mean
i=1 m = ------------n
with
xi = result in the main unit

n = number of results
i=n
( x m )2
i
Standard deviation
Variation coefficient
i--------------------------=1
n1
100
cv = -----------m
5.9.2 Quality Control screen
When you access this screen, the information displayed corresponds to the last control carried out.
The Quality Control screen is divided into several parts:
area for display of information about the level of the selected control
numeric display area for information on the selected point (using the cursor)
graphic display area for the DAILY CONTROLS
5-41
0931634 - October 2007

screens
4
numeric display area for the DAILY MEAN
graphic display area for the DAILY MEANS
numeric display area for the MONTHLY MEAN
graphic display area for the MONTHLY MEANS
numeric display area for the ANNUAL MEAN
area to display the test list
REFERENCE MANUAL
10 display area for the buttons related to the possible functions

11 display area for the test name
12 display area for the name of the graphic. When you click it, this area shows the scale
5.9.3 List of possible functions Quality Control screen
Allows you to run a quality control manually

Allows you to change the result acceptance range
Allows you to delete a quality control result
Allows you to validate a quality control result
Allows you to purge all quality control results for the level selected
Allows you to display the last quality control result
Allows you to transmit a quality control result
Allows you to display the controls of the day
5-42
0931634 - October 2007
REFERENCE MANUAL

screens
5.9.4 Test list Quality Control screen

bar.
For each test, you have a colored triangle that allows you to identify the status of the last control
associated with this test at a glance:
Validity control
Control in progress
Control to be validated
Erroneous control or unperformed
control
5.9.5 Information on the level of the quality control

Quality Control screen
In the areas 1 and 11 of the Quality Control screen (refer to chapter 5.9.5), the identification
number and the clear name of the quality control are repeated.
When running a quality control which has been requested and as long as it is not in progress, this
entire area is displayed in yellow. For each cuvette (2 for determinations performed twice), each
event is then represented by a symbol:
Control missing in Products drawer

product
processed
Distribution of the control in the

cuvette

reagent(s)
progress
progress (405 nm)
progress (540 nm)
During running, the lot number of the control used is shown.
5-43
0931634 - October 2007

screens
REFERENCE MANUAL
5.9.6 Definition of the terms used Quality Control screen
Term
Meaning
Daily control
In the graphic area, each point corresponds to a quality control result.
Daily mean

quality controls for a given day.
Monthly mean

quality controls for a given month.
Annual mean
In the digital results area, the values shown correspond to the average
(Moy.), the standard deviation () and the variation coefficient (CV)
calculated for the last 12 months.
5.9.7 Graphical displays
5.9.7.1 Graphical display of daily controls Quality Control screen

-
All the results of the daily controls for the day in progress (displayed by default when you access
this screen).
The result of each daily control displayed with a color code:
Daily control validated with a comment.

Daily control within the acceptance range.
5-44
0931634 - October 2007
REFERENCE MANUAL

screens
Daily control to be validated outside the acceptance range.

Daily control validated outside the acceptance range.
Daily control deleted with a comment.
Deleted daily control.
Erroneous daily control.
-

- of the default minimum and maximum thresholds (dotted white horizontal lines),
- of the average of the default acceptance range (solid horizontal white line) and corresponding
to the batch used for the control,
- of the change of batch (vertical blue line). The various white lines (see above) are represented
in terms of the numbers of the batches to which they are linked.
Note: Each result is represented by a point. When you have chosen duplicate determination for the
tests, you then have two points.
When you move over the various points in the DAILY MEANS, the result corresponding to the
selected point (
) in the graphic area is displayed numerically on the first line of the area for
information on the selected point.

When you move over the various points in the DAILY MEANS, all the results of the controls that
correspond to the selected day (
) are automatically redisplayed in the DAILY CONTROLS.
5.9.7.2 Graphical display of daily totals Quality Control screen

-
The results of the daily controls for the month in progress (displayed by default when you access
this screen). For a month, you can have 31 values at most. The number for each day is displayed
at the bottom of the graph. The average of the daily controls is called the daily total.
Each dot on this graph is identified by the status color of the last control of the day that it
5-45
0931634 - October 2007

screens
REFERENCE MANUAL

When at least one of the control of the day is commented, the dot of the corresponding daily total
is identified by a red mark.
-

- of the average of the daily totals solid yellow horizontal line),
- of the average area 2 of the daily totals (dotted yellow horizontal lines),
- of the average in the acceptance range (solid white horizontal line),
represented in terms of the numbers of the batches to which they are linked. For the monthly
total that corresponds to the change of batch, you keep the daily totals linked to the last batch
used in the month,
Note: When you move over the various dots in the DAILY MEANS, the numeric data (average,
standard deviation and variation coefficient) of the selected dot (
) in the graphic area are
displayed in a light color in the DAILY MEANS numeric area.

When you move over the various dots in the MONTHLY MEANS, all the daily totals that
) are automatically redisplayed in the DAILY MEANS.
5.9.7.3 Graphical display of monthly totals Quality Control screen

-
The monthly totals of the results of the quality controls for the last twelve months. This display
is of the sliding type. The number for each month is displayed at the bottom of the graph.
Each dot on this graph is identified by the status color of the last control of the month that it
When at least one of the control of the month is commented, the dot of the corresponding
monthly total is identified by a red mark.
The graphic representation for each calendar month:

- of the average of the monthly totals solid yellow horizontal line),
- of the average area 2 of the monthly totals (dotted yellow horizontal lines),
- of the average in the acceptance range of the last batch used in the month (solid white horizontal
line),
5-46
0931634 - October 2007
REFERENCE MANUAL

screens
represented in terms of the numbers of the batches to which they are linked. For the daily total
that corresponds to the change of batch, you keep the daily totals linked to the last batch used in
the day,
Note: The numerical data: average (Moy.), standard deviation () and variation coefficient (CV)
corresponding to each month selected (
area.
) are displayed in the MONTHLY MEANS numerical
5.9.7.4 Display of the graphic and its scale Quality Control screen
" Click the area of the name of the graph to display its scale.
The scale provides the following information:

-
The average of the acceptance range of the selected dot (value shown facing the solid white line).
The average area 2 s of the totals (value shown facing the dotted yellow horizontal lines).
The minimum and maximum thresholds (value shown facing the dotted white lines).
The value of the selected dot.
The values displayed on the scale of the graph are expressed in main units.
5-47
0931634 - October 2007

screens
REFERENCE MANUAL
5.9.8 Numeric information
5.9.8.1 Numeric information - Quality Control screen
In this area of the Quality Control screen, are displayed:

-
the information about the selected dot (selected using the cursor) for the day's controls,
the information about the selected dot for the daily totals,
the information about the selected dot for the monthly totals,
the information about the annual total.
When you access the Quality Control screen, the information displayed corresponds to the last
control carried out.
5.9.8.2 Information about the selected dot - Quality Control screen
Description of this graphic area of the Quality Control screen:

-
Display on the first line of the data related to the last control carried out (displayed be default
when you access the screen) with:
xx/xx/xxxx
Date that the quality control was performed (e.g. 07.02.2000).
5-48
0931634 - October 2007
REFERENCE MANUAL

screens
xx:xx
Date that the quality control was performed (e.g. 04:49:00 PM).
xxx U
Result of the quality control expressed in the main unit (e.g. 1.15 g/l)
These three pieces of information are displayed in:

- green when the result has been validated,
- blue when the result is to be validated,
- red when the result is validated outside the acceptance range or erroneously.
-
Display of the
icon when a comment is associated to the selected daily control. Click this
icon to read the comment.

-
Display of the lot number corresponding to the daily control selected (
Display of a symbol that identifies the conditions under which the selected control was run:
),
Control automatically run as a function of time.

Automatically run as a function of the number of tests.
Control run manually by the operator.
Control automatically run when products are loaded and when vials are changed.
Display of the minimum (Min) and maximum (Max) thresholds of the acceptance range that
correspond to the daily control selected (
) are repeated on the last line.
Note: When you move over the various dots in the graphic area of the DAILY CONTROLS, the
various graphic areas and the numeric values of the selected dot (
) are updated.
The
key allows you to move one step to the right (next dot) in the graphic area and the
allows you to move one step to the left (previous dot).
key
When a result is erroneous, no numeric value is available; an error code: Error, M>Mmax,
M<Mmin, Lin. and
is then displayed according to the type of error. For the meaning of the
error codes, see Color codes for results in chapter 5.4.9 of this manual.
Note: Mmin and Mmax values are raw measurements.
5-49
0931634 - October 2007
REFERENCE MANUAL

screens
5.9.8.3 Information on daily totals - Quality Control screen
DAILY MEAN Numeric area

-
the screen).
Note: When you move over the various dot in the graphic area of the DAILY MEANS, the various
graphic areas and the numeric values (average, standard deviation and variation coefficient) of the
selected dot (
The
) are updated.
key allows you to move one step to the right (next daily total) in the graphic area and the
key allows you to move one step to the left (previous daily total).
When you move over the various dot in the graphic area of the MONTHLY MEANS, the various
graphic areas and the numeric values (average, standard deviation and variation coefficient) that
) are automatically updated in the MEANS.
The
the
5.9.8.4 Information on monthly totals - Quality Control screen
MONTHLY MEAN Numeric area

-
Display of the mean (Moy.), of the standard deviation () and the variation coefficient (CV) that
the screen).
Note: When you move over the various dots in the MONTHLY MEANS, the various graphic areas
and the numeric values (average, standard deviation and variation coefficient) that correspond to the
selected month (
) are automatically updated.
5-50
0931634 - October 2007
REFERENCE MANUAL

screens
The
the
5.9.8.5 Information on annual total - Quality Control screen
ANNUAL MEAN Numeric area

-
correspond to the monthly totals for the last twelve months.
5.10 Patient File screen

5.10.1 Patient File screen
The Patient File screen appears when you double click a patient identification from the Test Panel.
It brings together all the information relating to a patient file with:
-
Patient ID number
Its possible markings (
If necessary, symbols indicating various specificities
The patients demographics information (possibly name, first name, etc.). This corresponds to the
contents of the complementary information found in the Global Options screen, see procedure
in chapter 5.12 of this manual
The positioning of the sample tube: rack number and position of the tube in the rack
The number of tests for the patient
The test list with the results and the associated statuses
If necessary, a complementary note
The dates
The indications of used limits
Extra data on measurements
The
button to give non-stat patients a stat status or the
patients a non-stat status
The
symbol displayed)
button (Normal) to give stat
button (transmission of a patient file)
5-51
0931634 - October 2007
REFERENCE MANUAL

screens
5.10.2 Writing a note

You can attach a complementary note to a patient identification.
This note is written when the patient files are printed. It is also transmitted directly to the server.
The note can be no longer than 50 characters.
You can write a note, or choose from a list of 10 standard notes.
-
Clicking once on the
Double clicking the
The
file.
button allows you to write a note.

button allows you to display the list of standard notes.
button allows you to select, to change and to assign a standard note to the patient
5.10.3 Dates - Patient File screen

Two dates are displayed in this area of the Patient File screen.
The Tube loaded date corresponds to the effective time and date the sample tube was loaded in the
pipetting area.
The Test ended date corresponds to the end of the measurement (or the measurements) for the
test on which the cursor is located.
5.10.4 Limits - Patient File screen

is located.
The validation limits and the printing limits are defined in the Test setup screens.
5.10.5 Raw measurement - Patient File screen

is located.
In the first column, you have the result(s) expressed in raw measurement, that is:
-
Sec. = Seconds for the coagulation tests,
.D.O. = delta of optical Density for the photometric tests in 2 point kinetics,
O.D./mn (optical density per minute) for the photometric tests in O.D./mn.
In the second column, you find the result(s) expressed in primary units.
Note: Results can be selected for single or duplicate mode. You will receive one or two results
accordingly.
5-52
0931634 - October 2007
REFERENCE MANUAL

screens
If a measurement is rerun, the old value is backed up and is displayed on the last line in this area.
5.10.6 Status of the results

Patient File screen
For each test, test status or result status.
The events in progress are represented by symbols. To these symbols are attached clear texts:
Running, Awaiting, Blocked and No Tube.
When a result is available, the possible statuses are: To be validated, Validated or Test invalid.
When one or more alerts have been associated with the result, the
Status column.
symbol is displayed in the
The re-diluted tests are displayed against a yellow background.
5.10.7 Test/Result/Status Patient File screen

In this area of the Patient File screen, the results of the patient file are displayed in the form of a
table.
The first column contains the test abbreviations, the second column has the average of the result
expressed in the primary unit. In the following columns (3, 4 and 5), you find the averages of the
results expressed in secondary units should this type of unit has been defined. Finally, in the last
column, the result status appears.
On each line of the table, you have the test abbreviation, the results (main and secondary units) and
the status associated with this test.
When you enter the screen, the cursor is located on the first test (first line). Extra information
relating to this test is displayed in the Dates, Range and Raw data areas. As you move the cursor
over the tests, these areas are updated.
The
symbol displayed beside the test abbreviation means that this test has been transmitted to
the server. It only appears in the details of the patient file it has not been previously downloaded.
5.11 Test setup screens

5.11.1 General information on the test configurations
5.11.1.1 Introduction
The test setups are available from the update menu after they are transferred to the user database.
5-53
0931634 - October 2007
REFERENCE MANUAL

screens
5.11.1.2 User database

The user database contains specific Diagnostica Stago tests (from the reference database) and the
tests defined by the operator.
Note:It is recommended not to exceed 200 test configurations in the user's database.
5.11.1.3 Reference database

The reference database contains all the tests and products available for the analyzer.
The reference database tests are not directly useable. To be able to use them, you must transfer them
to the user database using the
button in the Test setup screen.
The user may choose all the tests of interest from the reference database and then transfer them to
the user own database. The user may also delete the pre-defined Diagnostica Stago tests from the
user own database.
When all the operations involved in changing test setups are completed, the user will need to back
up the user database using the Save function in the Maintenance menu.
The color of the test setup changes depending on its status:
Color
Status of the test setup
Gray
Only exists in the reference database.
Blue
Exists in the reference database and in the user database.
White
Selected to be updated in the user database (the letter "T" appears in front of
the abbreviation for the test that is to be updated).
Green
Transferred to the user database.
5.11.1.4 Test setup screens

The Test setup screens can be accessed in the Setup menu by clicking the
clicking the Tests tab.
icon, then
The parameters for each test setup are then distributed over 5 sections (5 tabs):
-
Methodology,
Result,
Calibration,
Printout Transmission,
QC.
5-54
0931634 - October 2007
REFERENCE MANUAL

screens
5.11.1.5 Incubation schemas

The incubations defined for the sample and for each reagent should correspond to one of the
incubation schemas below:
Incubation schemas
Sample = >Incubation 1 => + Rd
Sample + Ra = >Incubation 1 => + Rd
Sample + Ra + Rb = >Incubation 1 => + Rd
Sample + Ra + Rb + Rc = >Incubation 1 => + Rd
Sample + Ra = >Incubation 1 => + Rb => Incubation 2 => + Rd
Sample + Ra + Rb = >Incubation 1 => + Rc => Incubation 2 => + Rd
5.11.2 Methodology tab Test setup screens
5.11.2.1 Methology tab

Methodology tab Test setup screen
On this page of the Test setup screen, all the parameters required for analyzer operation (i.e.
aspiration, delivery, incubation, stability, methodology etc.) are defined:
-
Identification of the test (Abbreviation, Name of the test, Method, Date of last update),
Sample (Volume, Incubation, Dilution),
Diluent (Identification, Name, Shelf-life; clicking the

parameters: Vial and Min. Volume),
button provides access to other
5-55
0931634 - October 2007
REFERENCE MANUAL

screens
-
Reagents (Identification, Name, Shelf-life, Volume, Incubation, Incubation precision; clicking the
button provides access to other parameters: Vial, Min. Volume, Pre-wash, Post-Wash and
Agitation).
Incubation, to find out more, see Incubation schemas procedure in 5.11.1.5 chapter of this
manual.
Calculated tests
Calculated tests are tests for which the result is a calculation expression taking one of the following
shapes:
(M1/ M2) x k
(M2/M1) x k
(M1- M2) x k
(M2-M1) x k
M1, M2: unpeaked mean value in raw unit (sec., OD or OD/min) of two primary tests selected by
the user.
K: programmable coefficient
Thus a result can be given that is either equal to a ratio between two tests or to a difference.
The result unit is implicit. It is either the ratio in case of a ratio calculation or the raw unit in case of
a difference calculation. Therefore, secondary units do not have to be defined for calculated tests.
As far as results are concerned, calculated tests have the same presentation, edition and transmission
characteristics as regular tests.
In the test panel, a calculated test can be identified by the "Sigma" () symbol.
This kind of calculation is only allowed for primary tests based on the same type of measurement
method (chronometry, colorimetry or immunology) and using the same raw units (sec., OD or OD/
min).
The results of the calculated test appear in the test panel only when the primary tests are complete
and their results have been given.
Calculated tests and dependent tests cannot be used as primary tests. Neither can they be copied so
as to serve as source for a new calculated test.
The deletion of a caclulated test does not bring about the deletion of M1 and M2 tests. For archived
tests, the deletion of M1 or M2 tests does not bring about the deletion of the calculated test either.
On the other hand, for the samples on board, the deletion of either M1 or M2 does bring about the
deletion of the calculated test.
Moreover, they cannot be validated manually: their validation is an implicit result of primary tests
validation. The error and alarm codes given to calculated tests are the most serious error code and
the most serious alarm code of those conferred to both primary tests. Only the alarm code H (result
in main unit limited to default values) is an exception to this rule as calculated tests results are never
peaked.
The very nature of calculated tests does not allow them to be rerun. If either of the primary tests is
rerun, the calculated test is automatically rerun.
In addition, there is neither calibration nor quality control for this type of test.
For more information about the creation of calculated tests, see chapter 3.10.4 of this manual.
5-56
0931634 - October 2007
REFERENCE MANUAL

screens
5.11.2.2 Identification
Test abbreviation
Short name of the STAGO test, contains 8 characters at most.

The abbreviated name of the customer test must contain
Test name
Complete name of the test (used for editing the results), contains
Date of last update
Last UPDATE = date of the last change made to the test setup
(backed up by the operator).
Method
Type of measurement method.

You have the following choices:
-
Clotting,
2 pts Color. = kinetic 2 point colorimetry,
OD/min Color. = kinetic O.D./minute colorimetry,
2 pts Immu. = kinetic 2 point immunology,
OD/min Immu. = kinetic O.D./minute immunology,
5.11.2.3 Sample
Sample volume
Distributed volume of the sample (Vol.) in microlitres (including

the dilution).
Possible choices: from 25l to 200l by increments of 1l.
The total volume (sample + reagents) should be between: 150l

and 400l for the chronometric methods, 250l and 400l for
Sample incubation
Incubation time (Incu.) of the plasma alone (with or without

dilution):
0 = no incubation
30 to 999 = incubation time (in seconds)
5-57
0931634 - October 2007
REFERENCE MANUAL

screens
Dilution ratio
Dilution ratio of the plasma expressed as follows:

-

D = 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 15, 20, 30, 40, 50, 60, 80, 100,
160, 200, 400.
5.11.2.4 Diluent

Product name
automatically.
Shelf-life of product in the STA-R Evolution in hours (Shelf-.).

Vial

automatically.
5-58
0931634 - October 2007
REFERENCE MANUAL
Minimum volume of
product

screens
5.11.2.5 Reagent

Product name
automatically.

automatically.
Reagent volume
Distributed volume of each reagent in microlitres (Vol.).

Possible choices: from 25 l to 200 l by increment of 1 l.
The total volume (sample + reagents) should be between: 150 l

and 400 l for the chronometric methods, 250 l and 400 l for
Reagent incubation
Incubation time (Incu.) of each reagent (from 0 to 999 seconds).

0 : no incubation.
Minimum incubation time = 30 seconds.
5-59
0931634 - October 2007
REFERENCE MANUAL

screens
Incubation precision
According to the override of time authorized for the incubations,

for the Prec. parameter, you will use:
: critical incubation, that is maximum override of 5 seconds.
: normal incubation, that is maximum override of 30 seconds.
Each override of incubation time will lead to the analysis being

abandoned (cuvette disposed of in the waste tray) and the
automatic rerun of the test in question. This should therefore be
reserved for truly critical incubations.
Vial

automatically.
Pre-wash
Type of cleaning to be carried out before each sampling of the

Possible choices:
-
No: no pre-wash,
Spec. : special pre-wash using a decontaminating solution to

be defined and rinsing with the STA-Cleaner Solution.

Post-wash
Type of cleaning to be carried out after each sampling of the

Possible choices:
-
Norm. : normal wash using the STA-Cleaner Solution,
Inten. : 2 normal types of wash,
Spec. : special wash using a decontaminating solution to be

defined + rinsing with the STA-Cleaner Solution.
Inten. +: 2 intensive cleanings for the releasing reagent.

5-60
0931634 - October 2007
REFERENCE MANUAL
Minimum volume of
product

screens
Stirring
Possibility of reagent agitation in the agitated position in the

products drawer for the client products (for the STAGO
products, this option cannot be changed).
5.11.3 Results tab - Test setup screens
5.11.3.1 Result tab

Result tab - Test setup screen
All the parameters required to define the modalities of the analysis and the processing of the result
are brought together on this page of the Test setup screen.
-
Analysis (Chronometry, 2 point Kinetics, OD/minute Kinetics, Rd heating, Agitation)
Result (Main unit, correction factor, determination, maximum standard deviation, re-dilution
criteria)
Acceptance limits (acceptance values)
5-61
0931634 - October 2007

screens
REFERENCE MANUAL
Note: The parameters in Analysis differ according to the type of measurement (Chronometry, 2
point Kinetics, OD/minute Kinetics).
5.11.3.2 Analysis
Chronometric analysis parameters
In chronometric tests, the following parameters determine the modalities of the analysis:
-
Min. Time,
Max. Time,
Mean Time,
Clot.
Minimum time
Min. Time = lower time limit for which no result may be

yielded.
In this case, you have an M<Mmin for the result.
Choices: from 3 to 999 seconds with Min. Time < Max. Time

applicable to the interpolations.
The Min. Time and Max. Time, if they are outside the field that
has been defined in this way, will be replaced by Ta and Tb
respectively.
Maximum time
Max. Time = upper time limit for which no result may be

yielded.
In this case, you have an M>Mmax for the result.
Choices: from 3 to 999 seconds with Min. Time<Max. Time.

applicable to the interpolations. The Min. Time and Max. Time,
if they are outside the field that has been defined in this way, will
be replaced by Ta and Tb respectively.
5-62
0931634 - October 2007
REFERENCE MANUAL
Mean time

screens
Mean Time = average estimated for coagulation times.

This is used by the software to adjust the cadence and avoid
congestion in the measurement area.
Under routine conditions, the risk of congestion is rather weak.
On the other hand, for a given test on important series of plasma
with very long coagulation times (anti-vitamin K treatment for
example), you must increase the average time so that the STA-R
Evolution slows the cadence down.
Choices: from 3 to 999 seconds with:
Min. Time<Mean Time<Max. Time.
Type of clot
Parameter acting on sensitivity in clot detection.

Possible choices:
Rd heating
NORMAL
WEAK
AVERAGE

Possible choices:
Stirring

Possible choices:
Analysis Parameters for 2 point Kinetics

In colorimetric or immunological tests in 2 point kinetic mode, the following parameters determine
the modalities of the analysis:
-
First point,
Second point,
5-63
0931634 - October 2007
REFERENCE MANUAL

screens
First point
First Point = time (in seconds) between the distribution of the

6 seconds at least for the 2-point kinetic mode.
Second point

the start reagent and the second optical reading point.
600 seconds at most for the 2-point kinetic mode.
This time should be greater than the Premier point time with a
deviation of
6 seconds.
Rd heating

Possible choices:
Stirring

Possible choices:
Analysis Parameters for OD/minute Kinetics

In colorimetric or immunological tests in OD/minute kinetic mode, the following parameters
determine the modalities of the analysis:
-
Min. linearity,
First point,
Second point.
Minimum linearity
Min. linearity = minimum linearity value acceptable for each

linear regression in the context of the OD/minute kinetic mode
Any result below this limit is assigned the Lin. error code.
5-64
0931634 - October 2007
REFERENCE MANUAL
First point

screens
First point = time (in seconds) between the distribution of the

4 seconds at least for the OD/minute kinetic mode.
Second point

the start reagent and the last optical reading point.
600 seconds at most (OD/minute kinetic mode).
This time should be greater than the First point time with a
deviation of
10 seconds.
Rd heating

Possible choices:
Stirring

Possible choices:
5-65
0931634 - October 2007
REFERENCE MANUAL

screens
5.11.3.3 Result
Primary unit
Main unit in which the results are yielded (Prim. unit) Test
setup screen
This unit is chosen in the Result tab; it is repeated in the
Printout/Transmission tab.
Possible choices:
Corrector
Raw: Sec. = Seconds, D.O. = delta of Optical density or

O.D./min. optical density per minute,
%: Percentage,
INR: International Normalized Ratio
U.A.5: Arbitrary unit n5.
Systematic multiplication factor that only applies to results

expressed in the main unit for yielding results.
This factor does not apply to the results of the controls.
Note: secondary results expressed in a unit other than Raw, Ratio,
INR or Reference time are calculated from the main result;
therefore they are subject to this correction factor.
5-66
0931634 - October 2007
REFERENCE MANUAL
Determination

screens
Determination type.
Valid for the samples and for the quality controls.
Possible choices:
-
DUPLICATE determination,
In Duplicate determination mode, the samples are treated

concomitantly and a calculation of the average is carried out. On
the other hand, for the same mode, the quality controls are
processed individually (no calculation of the average) and the
Max. Deviation/mean parameter is not used.
Max. deviation/mean
Max. deviation/mean = maximum difference authorized when

a duplicate determination is performed.
The deviation is expressed in % (relative deviation with
respect to the average) and applies to the raw data, that is to the
times for coagulation and to the O.D. or O.D./min for
colorimetry and immunology:
Deviation/Average =
M1 - M2
x 100
M
M1, M2: raw measurements,
M = (M1 + M2)/2.
In the specific case of 2 point kinetic immunological tests, you use

an absolute deviation, which is expressed in O.D.m:
Deviation = [M1 - M2] in O.D.m
Note: the results exceeding the max. deviation are:
Redilution conditions
tagged with the "O" alarm (incorrect duplicate tolerance)
assigned the "to be validated" status
Definition of two other possible dilutions for the sample if it leaves

the linearity area.
The linearity area is defined by the <Lower limit and
>Upper limit parameters.
The re-dilution possibilities are to be manipulated with care

because they are not always compatible with the dosage principle.
Note: The re-diluted result will be displayed in all the units
defined in the methodology.
5-67
0931634 - October 2007

screens
Dilution ratio
REFERENCE MANUAL

-

D = 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 15, 20, 30, 40, 50, 60, 80, 100,
160, 200, 400.
<"Lower limit

Definition of the lower limit of the linearity area in the main unit
The lower limit cannot be less than 0.
defined. Then any result less than this value will be automatically
rerun with the defined re-dilution rate. The result yielded takes
into account the change in dilution.
>"Upper limit

Definition of the upper limit of the linearity area in the main unit
The upper limit cannot be superior to 999.9.
defined. Then any result greater than this value will be
automatically rerun with the defined re-dilution rate. The result
yielded takes into account the change in dilution.
5.11.3.4 Acceptance values

Definition of the range of Min. and Max. values expressed in the main unit for yielding results for
which validation is carried out automatically.
Any result within this range is assigned Validated status and any result outside of this range is
assigned To be validated status, except if the result is tagged with the "O" alarm (incorrect
duplicate tolerance), see chapter 5.11.3.3 of this manual.
5-68
0931634 - October 2007
REFERENCE MANUAL

screens
5.11.4 Calibration tab Test setup screens
5.11.4.1 Calibration tab

Calibration tab Test setup screen
The parameters required to define the modalities of sampling for a test are displayed according to
the calibration mode chosen.
Raw mode:
Linear mode:
All the parameters required to define the modalities of sampling for a test are brought together on
this page of the Test setup screen.
5-69
0931634 - October 2007
REFERENCE MANUAL

screens
-
calibration mode,
type of determination,
measurement scales,
concentration scales,
calibrators,
offset corrector (for the colorimetry and immunology methods),
calibration controls.
5.11.4.2 Calibration mode

Definition of the calibration mode.
6 possibilities to choose from in the drop down list:
-
Linear: Linear regression on at least 2 points (Y = ax + b),
2nd order polynomial: 2nd order polynomial regression on at least 4 points (Y = ax + bx + c),
3rd order polynomial: 3rd order polynomial regression on at least 6 points

(Y = ax3 + bx + cx + d , reserved for immunological tests),
Hyperbolic: Hyperbolic regression on at least 5 points [Y = a + b / (x - N)],
Raw: Raw data (in the unit of measurement): seconds, O.D., or O.D./min,
Ratio: Ratio to a reference.
Note: depending on the type of scale chosen, x or y can become log x, log y,
If there is a pre-calibration, the
1
y
symbol is displayed.
Note: For the pre-calibrations, the data related to the calibration is transmitted by bar code labels,
a modality reserved fo the Diagnostica Stago tests.
5.11.4.3 Calibrator definition

The calibrators are only to be defined for the linear, second order polynomial, third order polynomial
and hyperbolic calibration modes.
Number of standards: from 2 to 8.
You should respect a minimum number of calibrators according to calibration mode.
The parameters required for definition of calibrators are:
- Identification,
- Key,
- Name,
- Shelf-life,
- Dilution,
- Vial,
- Min. volume
button.
Note: Calibrator identifications may be identical (use of a single calibrator) or different (use of
different calibrators). In both cases, you must specify the dilution required for each calibration point.
5-70
0931634 - October 2007
REFERENCE MANUAL

screens

Reading key

from a list corresponding to the order of parameters printed on a
bar code sheet contained in the products kit, the test or the
Product name
automatically.
Shelf-life

automatically.
Vial

automatically.
Minimum volume of
product

automatically.
5-71
0931634 - October 2007
REFERENCE MANUAL

screens
Dilution ratio

-

D = 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 15, 20, 30, 40, 50, 60, 80, 100,
160, 200, 400.
5.11.4.4 Calibrator determination

Type of determination for the calibrators.
Possible choices:
-
DUPLICATE determination, In this case, each point is considered to be an individual value.
Calibrator determination is only to be defined for the linear, 2nd order polynomial, 3rd order
polynomial and hyperbolic calibration modes.
5.11.4.5 Scales for measurements

Possible choices:
-
LINEAR,
LOG..
The scales for the measurements are only to be defined for the linear, second order polynomial, third
5.11.4.6 Scales for concentrations

Possible choices:
-
LINEAR,
INVERSE,
LOG..
The scales for the concentrations are only to be defined for the linear, second order polynomial, third
5-72
0931634 - October 2007
REFERENCE MANUAL

screens
5.11.4.7 Offset corrector

The offset correction parameters only apply to the colorimetric or immunological measurement
methods and only if there is linear regression. This correction allows you to correct the Yaxis at the
origin while keeping the slope and to compensate for reagents drifting. The offset corrector must
correspond to one of the calibration standards.
The parameters required for definition of offset correctors are:
- Identification,
- Name,
- Shelf-life,
- Vial,
- Min. volume
tab.

Product name
automatically.

automatically.
Vial

automatically.
5-73
0931634 - October 2007

screens
Minimum volume of
product
REFERENCE MANUAL

automatically.
5-74
0931634 - October 2007
REFERENCE MANUAL

screens
5.11.5 Printout/Transmission tab - Test setup screens
5.11.5.1 Printout/Transmission tab

Printout/Trans. Tab. - Test setup screen
This section allows you to define all the parameters for use of units:
-
Main unit,
Secondary units,
Conversion factor,
Use for editing,
Transmission rows,
Usual values,
Editing limits.
5-75
0931634 - October 2007
REFERENCE MANUAL

screens
5.11.5.2 Parameters
Secondary units
Conversion factor
Definition of 3 secondary units (Aux. 1, Aux. 2 and Aux. 3) that

can be printed and/or transmitted:
-
NO (no use of this secondary unit)
Raw: Sec.: Seconds, OD: delta of optical density or O.D./

min: optical density per minute),
%: Percentage,
INR:International Normalized Ratio
Ref.: reference time.
Conversion factor (Convers. Factor) between the main unit and

the secondary unit in question, when this can be applied (example
for main unit = g/l and secondary unit = mg/dl define a
conversion factor of 100).
The conversion factor, if not defined, is considered equal to 1.
The conversion factor, even if defined, is not applied whenever
the secondary unit is Raw, Ratio, INR or Reference time.
Use of unit for printout
To use main or secondary units when printing results, two choices

are possible (Printout column):
Unit used or result printed out using this unit.
Unit not used, or result not printed out using this unit.
This option applies also to the result display in the patient files.
5-76
0931634 - October 2007
REFERENCE MANUAL
Transmission Test
Number

screens
To use main or secondary units, you indicated the transmission

row corresponding to the server if the unit is used, that is:
transmission of the result expressed in this unit.
If the unit is not used in transmission, you must indicate 0 (
key).
Note: To request tests from the server (downloading a work list),
you must only use the row corresponding to the main unit.
You can print the list of transmission rows for the test setups
located in the client database to facilitate setup of the server.
" Click the
Usual values
icon.
Definition of the range of usual values in the main unit and in the
secondary units when the latter are defined.
5.11.5.3 Printout Limits

Definition of the range of acceptable values for any result in the main unit for yielding results.
Any result outside of this range is automatically yielded according to the context: either equal to the
minimum value (Min.) or equal to the maximum value (Max.) and is accompanied by an alert code.
5.11.6 Quality Controls tab - Test Setup screens
5.11.6.1 Quality Control tab

Quality Control tab - Test setup screen
5-77
0931634 - October 2007

screens
REFERENCE MANUAL
You should define 0 to 3 controls that will be integrated in the quality control files: Level 1, Level 2,
Level 3.
The parameters required for definition of quality controls are:
-
Identification,
Key,
Name,
Shelf-life,
Vial,
Min. volume
Running time.
5.11.6.2 Control Level

Reading key

from a list corresponding to the order of parameters printed on
a bar code sheet contained in the products kit, the test or the
Product name
automatically.
5-78
0931634 - October 2007
REFERENCE MANUAL

screens

Vial

automatically.
Minimum volume of
product

automatically.
5.11.6.3 Period quality controls taken

Definition of the period the controls were taken that is valid for all levels of quality controls.
3 possibilities are provided:
-
time interval (in hours),
number of tests,
at each change of vial.
You can choose a single type of period or aggregate 2 or 3
5-79
0931634 - October 2007
REFERENCE MANUAL

screens
5.12 Global Options screen

5.12.1 Global Options screen
The Global Options screen can be accessed using the

clicking the Global Options tab.
icon in the Setup menu, and then
This screen allows you to define some parameters that are specific to the laboratory.
-
Editing (definition of the laboratory identification),
Languages,
Dossier completion,
Entry of calibration parameters,
Miscellaneous options,
Definition of arbitrary units,
Regression coefficient (value from which the calibration will be validated automatically).

Options screen.
button to be able to change the parameters of the Global
5.12.2 Titles 1 and 2

2 lines of 34 characters to define the identification of the laboratory as it appears when printing
results.
5-80
0931634 - October 2007
REFERENCE MANUAL

screens
5.12.3 Languages
Possibility of changing the language of the interface: French, Italian, Spanish, English, German,
Portuguese, Danish or Swedish.
5.12.4 File Entry: Parameter for patient file acquisition

Each patient file is always located by its identification (16 alphnumeric characters maximum).
The laboratory may define 4 other complementary patient information fields to use as it wishes,
taking into consideration the fact that the number of alphanumeric characters per patient information
field is defined as follows:
The complementary information can be the name or the first name of the patient, or even the
department of the consulting doctor, etc.
This information is displayed in the Test Panel, in the Patient File Acquisition screen and in the
Patient File screen.
5-81
0931634 - October 2007

screens
REFERENCE MANUAL
5.12.5 Miscellaneous
General parameters
In this section, you define the following general parameters:

-
The Desorb by default,
The use of the audible alert,
The use of linear extrapolation,
The possibility of having automatic reruns,
The possibility of printing the alerts,
The possibility of automatically unloading the racks once the

analyses have been performed,
The possibility of printing online,
The possibility of transmitting all the results or only validated

results online,
The possibility of administering unread tubes: automatic

unloading of unread tubes so that they can be re-identified.
Desorb by default
Alphanumeric identification of the decontaminating solution to be

used by default every time the analyzer is started as well as every
time the analyzer starts a series of tests or enters dormancy.
Audible alarm
Possibility of generating an audible alert when an anomaly is

detected.
Audible alarm: Activated audible alert,
Audible alarm: Non-functional audible alarm.
Linear extrapolation
For all linear mode calibrations, the possibility of extrapolating

outside extreme points of the calibration.
When the linear extrapolation is activated, there is no limit to the
calculation of the results.
When the linear extrapolation is deactivated, patient and QC
results are calculated to the max. and min. measurement given by
the calibration.
Linear extrapolation: Extrapolation possible,
Linear extrapolation: Extrapolation impossible.
Note: for the modes of graphical calibration in 2nd and 3rd order
polynomial:
-
the extrapolation is never allowed
the patient results and QC are calculated to the min. and max.
measurement limit given by the calibration
5-82
0931634 - October 2007
REFERENCE MANUAL
Automatic rerun

screens
For all tests, the possibility of automatic rerun if there is a

technical error in time < minimum time or time > maximum
time.
Automatic rerun: Tests rerun automatically,
Automatic rerun: No automatic rerunning of tests.
Note: if the Automatic rerun option is not selected:
Alarm printout
tests in error do not bring about any rerun or redilution
tests with no error do not bring about any rerun but, they do
bring about a redilution when all the conditions for a redulition
are met
Possibility of including or not including the alerts related to the

tests when printing results.
Alarm printout: Results printed with alert(s),
Alarm printout: Results printed without alert.
On line transmission
Possibility of automatically transmitting test results at the end of

the measurements. When automatic transmission is activated,
possibility of only transmitting the validated results.
All Results: all the results (except for calibration) are
automatically transmitted to the server as soon as they are
available,
Only Validated Results: only the validated results are
automatically transmitted (results to be validated or erroneous
results are not automatically transmitted).
5.12.6 Arbitrary Units

For internal use, the laboratory may create up to 5 arbitrary units. These units can be used either as
the main unit or as a secondary unit.
The abbreviation for the unit (Name) can be defined using up to 5 characters.
The number of characters after the period (Dec.) should be defined.
Reminder: Every result is generated in 5 characters including the period.
The choices possible for the Dec. parameter are: 1, 2 or 3.
5-83
0931634 - October 2007
REFERENCE MANUAL

screens
5.13 Communications screen

5.13.1 Communications screen
The Communications screen can be accessed in the Setup menu by the

the Communications tab.
icon, then clicking
This screen allows you to define the parameters required for transmission of the results to a server.
The protocol used is ASTM.
-
The type of protocol (strict or extended),
The station number,
Transmission speed (300, 600, 1200, 2400, 4800 or 9600 bauds),
The type of parity (None, Even or Odd),
The number of DATA bits (7 or 8),
The number of STOP bits (1 or 2),
The number of trials should there be an error
The display of the symbol ( or u).

Communications screen.
button to be able to change the parameters of the
5-84
0931634 - October 2007
REFERENCE MANUAL

screens
5.13.2 The number of trials should there be an error

Dispatch number of a screen sent by the STA-R Evolution when a NACK message is received.
Possible choices: from 1 to 9.
5.13.3 Station number

Number allowing the server to identify the STA-R Evolution.
Choices: from 0 to 99.
5.13.4 Protocol type

The possibility of choosing between an ASTM protocol that is strictly identical to the one used on
STA and on STA Compact and a protocol likewise based on ASTM but using more possibilities.
Possible choices:
-
Strict: protocol identical to the STA /STA Compact ,
Extended: protocol with more possibilities.
5.13.5 Transforming the character

The ASCII character "" (micro) may be transformed into a "U" in the ASTM frames for the
transmission of results units and of notes associated to patients files.
The default option does not imply the transformation of the character "" during the transmission.
5-85
0931634 - October 2007

screens
REFERENCE MANUAL
5.14 Passwords screen
The laboratory may decide to reserve access to some functions of the software to specific people.
Each individual category found in the Passwords tab can be password protected. These passwords
are limited to a maximum of 6 characters. The user may first type in the Administrator password
in order to gain access to the Passwords tab.
When a password is attributed to a function, access to this function requires entry of the
corresponding password in the window that is displayed.
Before defining the various codes, carefully read the chapter 1.6 of this manual.
5-86
0931634 - October 2007
REFERENCE MANUAL

screens
5.15 Status - Counters screen
The Status - Counters screen allows you to view or administer some of the analyzer's parameters.
This screen is displayed by clicking the

button located in the system panel (lower right
portion of the screen). The user may access this screen at any time during any of the operations
screens.
5.15.1 Temperatures
Reagents Drawer: the temperature should be between 15C and 19C. If temperature is outside
of the recommended range, NOK (Not OK) is displayed against a red background, otherwise OK is
displayed against a black background.
Reagents arm 3 and Measuring block: if temperature is outside of the recommended range, it is
displayed against a red background, otherwise it is displayed against a black background.
5.15.2 Level detection management

This option allows you to activate or deactivate the level error administrator arm by arm (activated
option by default).
If the option is deactivated (cleared checkbox), the test results are marked by an alert
(E = arm 3, F = arm 2, G = arm 1).
If an analyzer is equipped with a plug piercing system, this option is not available for arm 1.
5-87
0931634 - October 2007

screens
REFERENCE MANUAL
5.15.3 Versions
Allows you to view the version of the STAPLUS software and the version of the eproms located on
the cards in the PC rack.
5.15.4 STAR serial number

Allows you to view the serial number of the analyzer.
5.15.5 Timer
Allows you to view the total length of operation of the machine (in hours) since its installation.
5.15.6 Suction pad

Allows you to view the total number of contacts carried out since the last change of suction cup.
The counter starts at 0 once the suction cup has been changed.
5.15.7 Availability before maintenance

The values displayed correspond to the number of cycles made by the piercing needle.
The value indicates the percent remaining until pipette maintenance is required.
When the values are displayed in red, it is necessary to perform the appropriate maintenance.
Number of piercings:
The counter starts from 100,000 and decreases. When the counter reaches 0, the value is displayed
in red. It is then necessary to change the needle (refer to chapter 4.8.1 of this manual). If the needle
is not changed, further test results are marked with an alert (N = Syringe arm 1 maintenance date
elapsed). The counter restarts from 100,000 after the needle is replaced.
Pipettings:
The counter starts from 100%. When the counter reaches 0%, the value is displayed in red. It is then
necessary to change the syringe tip and joint O-Ring in question (refer to chapter 4.5.1 of this
manual). If they are not changed, further test results are marked with an alert (L = Syringe arm 3
maintenance date elapsed, M = Syringe arm 2 maintenance date elapsed, N = Syringe arm 1
maintenance date elapsed). The counter restarts at 100% after the maintenance is performed.
5.15.8 Cuvettes
Allows you to view the code number of the reel and the number of cuvettes that are left in the reel.
This information is displayed permanently on the Products tab.
5-88
0931634 - October 2007
REFERENCE MANUAL

screens
" To load a new cuvette roll, click the

button then follow the procedure described in chapter
5.15.9 Cleaner Solution

Allows you to view the quantity of cleaning solution available. This information is displayed
permanently on the Products tab.
" To load a new 2.5 liter bottle of cleaning solution, click the
procedure described in chapter 3.3.3 of this manual.
button then follow the
5.16 CD/DVD recorder screen

This window is displayed during the back-up of data on a CD or DVD
Discs name:
The serial number of the analyzer is automatically displayed in this field.
This data will not be editable afterwards.
Erase:
This operation may take a long time.
Allows the deletion of a CD-RW (click
) before using it to record data.
Action:
-
A click on
allows to close the window.
A click on
allows the burning of a CD-R, CD-RW or DVD-R.
5-89
0931634 - October 2007

screens
-
REFERENCE MANUAL
Preserve the contents of the disc: do not clear this check box otherwise, the data already recorded
in the CD/DVD will be deleted.
When "100% burnt" appear at the bottom of the screen, this does not mean that the back-up is
complete. The back-up is complete only when the message "Burn succeed" appears.
The word "media" appearing in the window stand for "storage medium" (CD-R, CD-RW or DVDR).
Note:
The recorded files are stored in a directory named after the menu of origin of the recorded file. For
example: BackUpRestore, Tracking, TDEX, ExportCQs.
Each recorded file is stored in a subdirectory named with the date and hour of the record (aaaaamm-jj hh-mm).
5-90
0931634 - October 2007
REFERENCE MANUAL
Content
Troubleshooting
6.1
Error messages displayed in windows . . . . . . . . . . . . . . . . . . . . . . . . . 1
6.2
Specific messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
6.2.1
Message concerning the cuvettes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
6.2.2
Message concerning the buffer vial . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
6.2.3
Message concerning the measurement system . . . . . . . . . . . . . . . . . . . . . . . 3
6.2.4
Message concerning overlapping windows . . . . . . . . . . . . . . . . . . . . . . . . . . 4
6.3
Problems observed in the results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
6.3.1
List of points to check . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
6.3.2
Description of tests in error displayed on the test panel . . . . . . . . . . . . . . . . 4
6.3.3
Detailed description of a technical error . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
6.3.4
Typical problems in the results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
6.4
Problems connected to running analyses . . . . . . . . . . . . . . . . . . . . . . 8
6.5
Other problems observed . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
6.5.1
Problems in implementation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
6.5.2
Problem connected to STA-R Evolution shutting down . . . . . . . . . . . . . . 10
6.5.3
Various problems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
6.5.4
Filter replacing procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
.......................................... 1
1
0931634 - October 2007
Content
REFERENCE MANUAL
2
0931634 - October 2007
REFERENCE MANUAL
Troubleshooting
6 Troubleshooting
6.1 Error messages displayed in windows
Type 1:
"Run time error xxx at................"
Or
"Disk error............................"
"Fatal error.............................."
Type 2:
"Critical error
Problem reading [address] [file name]"
"Index outside limit
(0), (-1) or (-2)"
""" is not a correct integer value"
"Access violation # [address] [module name]"
Type 3:
A message is displayed in a pop-up window.
Example:
Procedure to follow if a message appears:

" Record the error displayed for type 1 or 2 messages; print out the type 3 messages.
" Describe the context before the message appeared and what caused the message to appear.
" Depending on the message displayed, click
or
to continue, or
to stop.
" If the problem persists, shut down the STA-R Evolution according to the usual procedure (see
procedure in chapter 3.11.1 of this manual), wait 3 minutes and then turn the analyzer on again
" If the problem still persists, call the hotline and report the information given in the screen.
6-1
0931634 - October 2007
Troubleshooting
REFERENCE MANUAL
6.2 Specific messages

6.2.1 Message concerning the cuvettes
Example:
The user needs to lift the transparent cover and examine the measurement block and incubation
areas. Manually remove any stray cuvette(s) that maybe left here. Use the tweezers tool found in the
accessory kit to carry out this operation. After the stray cuvette(s) have been removed, close the
transparent cover. Make sure the tweezers tool is decontaminated using the decontaminating
solution.
Probable cause(s)
Defective suction tip.
" Proceed with cleaning the suction cup (see

Ball or fragments of broken cuvettes

present in the measurement or incubation
well that causes the cuvette to be poorly
positioned.
" Access the Maintenance menu
Grip filter.

Damaged cuvette.
" Remove the cuvette.
" Open the transparent cover.

" Remove the ball or the fragments of broken
cuvettes.
6-2
0931634 - October 2007
REFERENCE MANUAL
Troubleshooting
6.2.2 Message concerning the buffer vial
Example:
Probable cause(s)
STA-Cleaner solution bottle empty
" Replace it if necessary (see procedure in

chapter 3.3.3 of this manual).
Grip filter

6.2.3 Message concerning the measurement system

If a photometry error is detected during photometer measurement, any pending photometric tests
will be suspended. The
icon appears in the System Panel. Double clicking this icon will allow
you to display a more detailed description of the error. One of the following messages will then
appear in the Photometer Error(s) window:
Message
Probable cause
Possible solution
Lamp Error
The light level of the lamp is too

weak or too strong.
Replace the lamp (see

procedure in chapter 4.8.3 of
this manual).
Overrun
Mechanical problem
Call the hotline
6-3
0931634 - October 2007
Troubleshooting
REFERENCE MANUAL
Motor failure
Motor problem
Call the hotline
Unknown
Unknown problem
Call the hotline
When there is a problem with the photometer, all the colorimetric and or immunological tests are
blocked. You must resolve any photometric problems (see possible solutions above) prior to rerunning any photometric tests.
6.2.4 Message concerning overlapping windows

In some cases, on screen overlapping windows can lead to software lockups. The user can no longer
close windows or validate commands in them.
" Click the
icon to close each window or validate its commands.
6.3 Problems observed in the results

6.3.1 List of points to check
When you observe a problem in the results, you should do the following:
" Check the rinsing volumes (see procedure in chapter 4.4.5 of this manual),
" Carry out a quality control and a check of its value against the previous values.
" Check the test setup menu: select the test in question. Examine each parameter in the Test
Setup menu and compare it with the methodologies recommended by Diagnostica Stago.
" Check the reagents: reconstitute and load new vials of reagent(s) etc.
" Run a second quality control. Check its value against the previous values.
" When running single result assays, check the results of other routine tests.
" Check that the weekly and monthly maintenance has been properly carried out.
6.3.2 Description of tests in error displayed on the test panel

See chapter 5.4.7 of this manual.
6.3.3 Detailed description of a technical error

When a test is erroneous (Error is displayed in the control panel), you can have a detailed description
of the technical error generated.
" Double click Error.
6-4
0931634 - October 2007
REFERENCE MANUAL
Troubleshooting
" In the menu that appears, click one of the two options available:
- Error... : for a single measurement,
- Error #x... : for a double measurement (x = measurement row)
The description of the error is displayed.
" Write down the error code (located at the bottom right of the window) to send it to the hotline
if necessary.
" Press the Return key, the space bar or the
icon to close the window (If no action is taken,
the window will automatically close after 30 seconds).
6.3.4 Typical problems in the results

The examples below are expressed in coagulation time and concern 3 routine mixed tests (patient
by patient)
6-5
0931634 - October 2007
REFERENCE MANUAL
Troubleshooting
TQ time
TCA time
Fibrinogen
time
Probable
cause(s)
OK
Short or long
OK
Poor pipetting
in needle n2
" Check rinsing of

needle n2 (see
the mandrel punch
(see procedure in
manual).
Contamination
of needle n2

the mandrel punch
(see procedure in
manual).
suction in opening
(see procedure in
manual).
" Call the hotline
Short
Short
OK
Contamination
of needle n3
" Ensure opening of

needle n3 using the
mandrel punch (see
suction in opening
(see procedure in
manual).
contaminated
STA-Desorb
U
OK
OK
Long
Poor sample
pipetting
(dilution)
" Change the STADesorb U vial

" Call the hotline
" Check rinsing of
needle n1 (see
" Unstop needle n2
using the mandrel
manual).
" Call the hotline
6-6
0931634 - October 2007
REFERENCE MANUAL
Troubleshooting
TQ time
TCA time
Fibrinogen
time
Probable
cause(s)
Short or long
Short or long
Short or long
Poor pipetting
in needle n3
" Check rinsing of

needle n3 (see
" Unstop needle n3
using the mandrel
manual).
" Replace the teflon tip
of the syringe (see
" Call the hotline
6-7
0931634 - October 2007
Troubleshooting
REFERENCE MANUAL
6.4 Problems connected to running analyses

Type of problem
Probable cause(s)
For a given test, the

analyses are not
carried out.
The test has been blocked:
" Unblock the test.
The
Test panel for this test.
Products used to perform this test

are missing:
-
The
The
There is no validated calibration for

this test:
-
The
The
icon is displayed
and flashes in the Test panel.
" Double click the

icon to
" If necessary, load the missing
products.
" Double click the

the Test panel:
icon in
The Product Forecast screen

is displayed if the calibration
cannot be carried out because
of missing products or if the
barcode sheet corresponding
to the vial on board has not
been read,
The Calibration screen is
displayed if a calibration is to be
validated.
" Read the barcode sheet of the
products on board.
" Run the calibration for this test.
" Run a quality control for this
test.
6-8
0931634 - October 2007
REFERENCE MANUAL
Troubleshooting
Type of problem
Probable cause(s)
No analysis is
carried out.
The sampling has been blocked:
" Unblock all tests:
Either:
-
the
Test panel
The
Or:
-
by tagging all the files: clicking

each test column heading then
Unblock
" If necessary, reload the missing

products.
" Carry out the missing
calibrations.
The
icon is displayed for all
tests to be performed.
STA-Desorb U not found in

drawer:
-
icon if it is
displayed,
and
-
by clicking the
the
and
icons are
displayed and flash in the Test
panel.
" Double click the

icon;
the reason the tests were
blocked is described:
"Blockage Desorb
missing..."
or
" Double click the
icon to
" Load a vial of STA-Desorb U
in R0, R1 and R2.
6-9
0931634 - October 2007
REFERENCE MANUAL
Troubleshooting
6.5 Other problems observed

6.5.1 Problems in implementation
Problems observed
Probable cause(s)
Black screen, no response

from the keyboard and the
STA-R Evolution does not
start.
Power supply is not connected.
" Properly connect the

power supply
The wall socket or the extension

socket is out of order.
" Connect the STA-R

Evolution to another
power outlet.
The main fuses have blown.
" Change the main fuses.
The analyzer is out of order.
" Call the hotline
6.5.2 Problem connected to STA-R Evolution shutting down
Problem observed
STA-R Evolution Software does not respond

Ctrl + Alt +S
If this does not work:
Ctrl + Alt +F10
Note:
If tests were running before an emergency shutdown, they are automatically rerun upon the
software restart.
If results were displayed before an emergency shutdown, they are automatically displayed again
upon the software restart.
6.5.3 Various problems

Problem printing bar codes:
The last labels are partially printed.
6-10
0931634 - October 2007
REFERENCE MANUAL
Troubleshooting
Probable cause(s)
Incorrect printer setup.
" Check printer setup using the button.
" Change the paper to a standard paper size.

Problem reading tubes:
Probable cause(s)
Poorly positioned label.
" Check that the recommendations below are followed:

-
Stick the label on to a clean tube,
The bars on the label should be perpendicular to the axis

of the tube:
RIGHT
WRONG
The position of the label on the tube should conform to

the following dimensions:
If there are already labels on the tubes, you must cover all
the existing bar codes when you apply the new label.
6-11
0931634 - October 2007
Troubleshooting
REFERENCE MANUAL
Problems associated to operation of the touch screen:

A significant electromagnetic field can disrupt operation of the screen. If there is a problem, contact
the Hotline.
6.5.4 Filter replacing procedures

Liquid filter replacement procedure:
Ref. : 27458
" Click the
icon.

" Remove the 2.5 liter bottle of STA-Cleaner Solution.
" Replace the A marked filter and dispose of the old one according to the regulations locally in
force.
Note: The message "The Bottle of Cleaner is missing" may be displayed.

" Replace the 2.5 liter bottle of STA-Cleaner Solution.
" Close the message if it was displayed.
" Proceed with purging the needles so as to dispose of possible bubbles in the circuit (see
Grip filter replacement procedure:
Ref. : 27458
" Click the
icon.

" Open the top right side door.
6-12
0931634 - October 2007
REFERENCE MANUAL
Troubleshooting
" Replace the filter marked A and dispose of the old one according to the regulations locally in
force.
" Close the top right side door.
End of document
6-13
0931634 - October 2007
Troubleshooting
REFERENCE MANUAL
6-14
0931634 - October 2007
REFERENCE MANUAL
Index
A
Acceptance thresholds . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-26
Alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-59, 5-10
Audible alert . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-81
Archives . . . . . . . . . . . . . . . . . . . . . . . . . . 3-3, 3-78, 4-35, 4-37, 5-8, 5-14
ASTM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-18, 5-83 5-84
Automatic
Identification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-34
Automatic identification . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-35 3-36, 3-41
Automatic profile . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-34, 3-41
Automatic rerun . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-82
B
Back up
Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-35
Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-38
Bar code label . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-34
Bar code reader . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-18
C
Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-70, 5-34, 5-36, 5-68
Interpolated results for the calibrators . . . . . . . . . . . . . . . . . . . . . . . 5-39
Meaning of the colored triangles . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-35
Raw measurements for the calibrators . . . . . . . . . . . . . . . . . . . . . . . 5-38
Theoretical concentration of the calibrators . . . . . . . . . . . . . . . . . . . 5-38
CD/DVD recorder . . . . . . . . . . . . . . . . 2-5, 4-36, 4-39, 4-45, 4-51, 4-54
Chronometry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-6
Cleaner solution . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-12, 5-88
Clot . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-6, 5-62
Colorimetry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-17
Condensation trap . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-2
Cuvette . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-11
Loading the cuvette reel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-8
Number of cuvettes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-87
Cuvette disposal bag . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-11
Cuvette disposal bin . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-11
Cuvette reel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-11, 3-8
Tracking . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-8
D
Daily Controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-26, 5-43
Daily total . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-43 5-44
1-1
0931634 - October 2007
Index
REFERENCE MANUAL
Date (setting) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1

Decontaminating solution. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-33
Decontamination
Decontamination procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-33
Detection of level . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-12, 5-86
Dilution . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-57
Diskette drive . . . . . . . . . . . . . . . . 2-5, 4-35, 4-39, 4-45, 4-50, 4-54, 5-6
Duplicate
Assay . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-56
E
Error message . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-1
Concerning the buffer vial . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-3
Concerning the cuvettes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-2
Processing an error message . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-1
F
Fuse . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-30 4-31
G
Grip . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-13, 5-87
Grip filter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-12
I
Icon . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-3
Immunological
Measurement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-6 2-7
Immunology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-17
Incubation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-9, 2-11
Incubation block-measurement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-11
INR . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-76, 5-65
Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1
Insufficient quantity of plasma . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-5, 5-15
Intermediate reagent . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-9
Intermediate reservoir . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-16
ISI . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-76, 5-34
K
Kinetics
2 point Kinetics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-62
DO/minute Kinetics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-63
Knurled nut . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-25
1-2
0931634 - October 2007
REFERENCE MANUAL
Index
L
Language of the interface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-80
Linear extrapolation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-81
Loading
Cleaner solution . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-12
Cuvette reel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-8
Products . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-11, 3-15, 5-24
Samples . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-9, 3-32, 5-19
Urgent sample . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-40 3-41
M
Main
Re-diluted . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-52
Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-80 3-81
Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1
Decontamination . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-33
Schedule of preventive maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . 4-2
Telemaintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-40
Maintenance utility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1
Mandrel punch . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-6, 4-33
Manual identification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-36, 3-38
Mapping . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-24
Measurement plate
Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-13
Error message . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-3
Monthly total . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-43, 5-45
N
Note . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-50 5-51
O
Off . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1
Offset corrector . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-72
On . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-82
Optical density . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-17
O-ring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-16
P
Panel
Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-2
System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-2
Password . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-41, 5-85
1-3
0931634 - October 2007
Index
REFERENCE MANUAL
Patient dossier
Archiving . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-78
Routine administration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-48
Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-22
Urgent patient dossier . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-65
PC Anywhere . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-40
Pediatric . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-32, 3-50
Photometric graph . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-61
Plunger . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-8
Problem
Implementation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-10
Running analyses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-8
Shutting down the instrument . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-10
Purging the needle . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-10 4-11, 6-12
Q
QNS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-5, 5-15
Quality control
Comments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-6, 3-24 3-25
comments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-32
Control Level . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-77
Threshold values . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-31, 5-39
R
Rack
Administration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-42
Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-20
Rack conveyor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-20
Reference time . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-76, 5-34
Releasing reagent . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-9, 3-4
Reloading the racks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-6, 3-46
Remote link . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-40
Repeatability . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-17, 5-20
Restoring data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-36
Result
Back up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-35
Graph . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-61
Status . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-52
Results status
Color code . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-14
List of possible statuses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-52
Symbols used in the control panel . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-18
Rinse solution . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-12, 5-88
1-4
0931634 - October 2007
REFERENCE MANUAL
Index
S
Screen
Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-3
Reading . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-1
Shut down
Emergency shutdown . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-4, 5-3
Prolonged shut down . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-85
Routine shut down . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-84
Shuttle transporter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-14
STA-Microcups . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-16, 5-29
Standard deviation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-45
Stirring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-11, 3-5, 5-28, 5-60
Suction tip . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-9
Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-13
Replacement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-28
suction tip . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-5
T
TDex . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-38
Teflon tips . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-15
Telemaintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-40
Test profile
Automatic profile . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-34
Defining a profile . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-50
Using a profile . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-52
Thumb screw . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-12, 4-16, 4-29
Time (setting) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1
Transmission
Identification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-82
Online . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-82
Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-1
U
Unit
Arbitrary units . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-82
Choose the unit for display in the control panel . . . . . . . . . . . . . . . . 3-69
Main unit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-65
Unread tube . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-3, 5-81
Urgent . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-65
V
Vacuum pump . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-2
1-5
0931634 - October 2007
Index
REFERENCE MANUAL
W
Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2, 3-15
Work list . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-35, 3-53
1-6
0931634 - October 2007

652 1260 1 PB

Uploaded by

Document Information

Original Title

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

652 1260 1 PB

Uploaded by

Copyright:

Available Formats

STA-R Evolution Reference Manual

FOR ANY INFORMATION, PLEASE CALL

Chap 1: Warnings and symbols

Warnings and symbols

Meaning of the symbols used in STA-R Evolution . . . . . . . . . . . . . 1

Warnings regarding the use of biological products . . . . . . . . . . . . . . 2

Warnings regarding test settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

Warnings regarding the use of access security . . . . . . . . . . . . . . . . . . 4

Warnings regarding the STA-R Evolution system . . . . . . . . . . . . . . 5

Warning regarding the analyzer disposal . . . . . . . . . . . . . . . . . . . . . . . 6

Warnings and symbols

1 Warnings and symbols

Warning, consult the

Off (turn current off)

On (turn power on)

Medical equipment for in vitro

Name and address of

Do not turn by hand

Separate collection: do not

Keep away from magnetic

Disposable gloves mandatory

Mask and goggles must be

Liquid that may be

Temperature limits for

Warnings and symbols

1.2 General warnings

1.3 Warnings regarding the use of biological products

Warnings and symbols

(i) respect all recommendations,

1.4 Warnings regarding test settings

Pre-analysic conditions regarding samples: to maintain the activity of various coagulation

Warnings and symbols

1.5 Bibliography - Warnings

KOEPKE J. A., McLAREN C. E., WIJETUNGA A. AND HOUWEN B.:

1.6 Warnings regarding the use of access security

Routine functions (example: launching analyses, loading products),

Modification functions (example: creation or modification of test configurations).

For all these functions, security levels can be defined.

Warnings and symbols

1.7 Warnings regarding the STA-R Evolution system

upper left side cover

lower left side cover

upper right side cover

lower right side cover

access cover for the tube turning wheel

STA-OWREN KOLLER dilution buffer,

Warnings and symbols

1.8 Warning regarding the analyzer disposal

Setting date and time . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

Connecting peripheral devices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2

Presentation of the analyzer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

Purpose of the analyzer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

General description of the analyzer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

Description of the measuring system in chronometry . . . . . . . . . . . . . . . . . . 6

Description of the measuring system in photometry . . . . . . . . . . . . . . . . . . . 7

Description of steps in analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

Description of sample loading . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

Description of product loading . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

Description of the incubation block-measurement . . . . . . . . . . . . . . . . . . . 11

Description of the cuvette movement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

Description of the distribution of plasmas and products . . . . . . . . . . . . . . . 12

STA-R Evolution technical specifications Part 1 . . . . . . . . . . . . . . . . . . . 12

STA-R Evolution technical specifications Part 2 . . . . . . . . . . . . . . . . . . . 13