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REF 80649

0931275D
Non contractual picture

Reference Manual
Name and address of the retailer:
Information contained in this document, in particular data, pictures, information, trademarks and logos
are protected by copyrights and other intellectual property rights.

©2004, Diagnostica Stago, all rights reserved - 11/2011.

Consequently, all representation and/or reproduction, whether in part or in full, is forbidden and would
be considered a violation of Diagnostica Stago’s copyrights and other intellectual property rights.
REFERENCE MANUAL
Revision table

REVISION TABLE

Manual Date Software List of modifications


version version

0931275 September 2004 410.xx Not released version

0931275A June 2008 421.04 First released version

0931275B October 2008 421.05 Chapter 1:


- Standard update
Chapter 4:
- Deletion of the chronometry curves
display
Chapter 6:
- Addition of beep sounds (analyzer
ready for loading)

For the whole reference manual:


- Screenshot update
- Minor modifications

0931275C November 2010 422.05 Chapter 3:


- Modification of the "Cuvette Roll
Change" messages.
Chapter 6:
- There are no more validation step
(confirmation message) in the end of:

* product complete loading


* sample complete loading
* product single loading

- Display of the name, the stability and


the volume for a Stago reagent loaded
manually (identification data entry).

For the whole reference manual:


- Screenshot update.

0931275D - November 2011


REFERENCE MANUAL
Revision table

REVISION TABLE

Manual Date Software List of modifications


version version

0931275D November 2011 423.06 Chapter 1.1:


- Symbol meaning update.
Chapter 1.2:
- Modification of the sentence No (iii).
Chapter 2:
- Standards update.
Chapter 4:
- Addition of a "save/rereading"
precaution
- Addition of the following languages in
the user interface : German, Italian
and Spanish.

For the whole reference manual:


- Screenshot update.

0931275D - November 2011


REFERENCE MANUAL
Table of Contents

1 Symbols and warnings

2 Introduction

3 Preparation of the STA Satellite

4 Maintenance

5 Test setup

6 Product and sample loading

7 Calibration

8 Patient file management

9 Quality Control

10 Miscellaneous screens

11 Troubleshooting

12 List of tubes

13 Maintenance schedule (tabular form)

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1 Symbols and warnings .................................... 1

1.1 Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

1.2 General warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2

1.3 Warnings regarding the handling of biological products . . . . . . . . . 2

1.4 Warnings regarding test settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

1.5 Warnings regarding the use of the access codes . . . . . . . . . . . . . . . . 4

1.6 Warnings regarding the STA Satellite system . . . . . . . . . . . . . . . . . 5


1.6.1 Extended stop of the STA Satellite ............................... 7
1.6.2 Warning regarding the analyzer disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

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Symbols and warnings

1 Symbols and warnings


1.1 Symbols
ˆ On the analyzer

Alternating current Direct Current

Warning, consult the


Protective earth
accompanying documents

Off On (turn the power on)

Warning, risk of electric


Biohazardous elements
shock

Medical equipment for in


Do not introduce hands
vitro diagnosis

Separate collection: do
Name and adress of the not discard with other
manufacturer waste. Product put on the
market after 13/08/20051
1.See chap. 1.6.2 for additional information about the disposal procedure
ˆ On disposable items

Keep away from magnetic


Use only once
fields

Mask and goggles must be worn Disposable gloves mandatory

Liquid that may be contaminated


biologically

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ˆ In the documentation

Warning, important information Additional information

Precautions to be observed in Initial situation


order to use the analyzer in
accordance with its specifications 2
and to avoid damaging the
analyzer.

Screen display " Shows an action to perform


 Shows the result of an action

1.2 General warnings


The use of the STA Satellite requires a training provided either by DIAGNOSTICA STAGO
or by one of its official distributors.
In order to ensure the correct operation of the STA Satellite system, it is imperative to
acknowlege and to comply with any and all of the analyzer warnings, instructions and
procedure 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 Satellite 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 4th, 2002 n°104) 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"local", we understand the territory in which the STA Satellite system is installed)
are hereafter collectively referred to as the "Recommendations".
Under no circumstances DIAGNOSTICA STAGO, its employees, its suppliers or a third
party mentioned in the 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 Satellite 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 Satellite system is specified in an
adaptation protocol,
(III) in case of use of tubes other than those specifically listed in chapter 12 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 commercialized by Diagnostica Stago and/or
by its official distributors,

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Symbols and warnings

(V) in case of non-performance of the current and regular maintenance operations,


calibration and support operations set forth in the present manual and permanently
required to ensure the correct functioning and security of the STA Satellite system,
(VI) in case the STA Satellite system is not decontaminated in accordance with the
decontamination procedures set forth in this manual.

1.3 Warnings regarding the handling of biological products


For the handling of reagents, calibration plasmas, control plasmas and patient’s plasma
(hereafter referred to as “Products”), read carefully the inserts provided with each product.
Before any intervention on the STA Satellite system, to ensure the safety of the staff
working in contact with biohazardous products, and to allow a proper execution of the
biological assays, please observe the following instructions:
(I) Respect all recommendations
(II) Make sure that the STA Satellite is decontaminated in conformity with the
decontamination procedures described in this manual
(III) Observe all norms and safety measures imposed on laboratories for the execution of
biological analyses involving biohazardous products in accordance with the regulations
in effect locally
For instance, the following precautions must be observed:
ˆDo not eat, drink or smoke in places where these products are handled,
ˆImmediately consult a physician if any of these products is ingested or comes in
contact with mucous membranes or skin lesions (wounds, cuts, etc.),
ˆUse disposable gloves and handle all products as potential sources of infections,
ˆEliminate all products as if they were infected in accordance with the law and the
regulations locally in effect (for instance: autoclaving, incineration of disposable
equipment, elimination of liquid wastes see Liquid waste management
(ref. 0931716x) or regulations locally applicable).

1.4 Warnings regarding test settings


Not following the conditions regarding test settings may have consequences on the
reliability of the results as well as on the execution of any biological analysis on the
STA Satellite system, therefore the following conditions must be observed.
ˆ Pre-analytic conditions regarding samples: in order to ensure the activity of various
coagulation factors, samples must be drawn with care following the recommended
standards for sample collection; only tubes with proper citrate concentration should be
used.
The quality of the centrifugation and the storage temperature of samples should also be
carefully ensured before the 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 frozen may contain sediments when thawed. These sediments
should be removed before measurement.

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Symbols and warnings

- Pre-analytic conditions regarding products and reagents: the laboratory must strictly
comply with the instructions provided by the manufacturer in the product and reagent
inserts. Poor preparation of the reagent regarding reconstitution volume, stabilization
time, stirring, presence of bubbles, forgetting or inappropriately leaving 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 of the STA product. Any change in
lot, any software update - like any intervention - should give rise to verification of the ISI
value.

ˆ Configuration and condition of the analyzer: the laboratory must make sure that the test
settings comply with the manufacturer’s prescriptions for reagents, especially regarding
volumes to be used, incubation times, rinsing solutions, buffers, etc.The laboratory must
ensure that the maintenance of the analyzer is performed on a regular basis and in
conformity with 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 reliability and safety, it is impossible to guarantee an error rate of
zero.
For example: studies carried out on the prothrombin rate have demonstrated that when
the pre-analytic 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 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.

ˆ Conditions regarding the validation of methods and of techniques


- The test settings provided by Diagnostica Stago have been validated individually for the
STA Satellite 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 test settings that have not
been validated by Diagnostica Stago as compatible with the STA Satellite analyzer, a
validation of this new system will be required. This validation will ensure that the
characteristics of the method are verified (see references, 2nd reference) and that any
possible interactions between the new and the old products are checked.
ˆ When 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 (see references, 2nd reference).

ˆ Analysis of results:
- Results given by the analyzer must always be analyzed according to the patient’s history,
the clinical examination and any other biological results.
- Result error codes (technical error, V<Vmin, V>Vmax...) need biological interpretation.
For any question regarding this matter, contact the hotline.

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Symbols and warnings

REFERENCES
1 VASSAULT A. et al. :
“Protocole de validation de techniques”. Ann. Biol. Clin., 44, 686 - 745, 1985.

2 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.

1.5 Warnings regarding the use of the access codes


The functions of the STA Satellite analyzer can be sorted into 2 categories:
ˆ routine functions (example: running calibrations).
ˆ modification functions (example: creation or modification of test settings, see above
chap. 1.4).
All of these functions are protected by access codes. The use of routine functions has no
incidence on the results obtained. However, the use of modification functions may affect the
reliability of the results.
Therefore, it is required that each laboratory assesses the consequences of the use of the
different functions prior to the assignment of access codes.

1.6 Warnings regarding the STA Satellite system

The STA Satellite was made and tested according to the CISPR 11 (International Special
Commitee On Radio Interference) for class A equipment.
The analyzer conforms to the EN 61326-2-6:2006 standard.
The electromagnetic environment should be evaluated before turning on the analyzer.
Keep away from the analyzer all sources of high electromagnetic radiation (cellular phones,
unprotected sources of radiofrequency...) as they may interfere with the operating conditions
of the analyzer.
The STA Satellite may only be installed by personnel duly authorized by Diagnostica Stago
or by its official distributors.
Once the STA Satellite has been swtched off, wait for 30 seconds, at least, before
switching it back on.
In order to avoid any risk of electric shocks, it is essential that the procedures described in
this manual are scrupulously observed.

RISK OF BIOLOGICAL CONTAMINATION


In order to avoid biological infections, use disposable gloves when the needle has to be
handled.

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Prior to handling the needle, unplug the J2 connector from the head board (see fig. 23 of
chap. 4.7.2).

RISK OF BIOLOGICAL CONTAMINATION


RISK OF INJURY
You must turn the analyzer off before any intervention within the cutter area.

Install the STA Satellite on a stable support that is insensitive to vibrations.


Do not obstruct air vents, especially the ones located above the screen and underneath the
analyzer.
Make sure that the STA Satellite is positioned in such a way that it can be easily unplugged.
All covers (samples, products and measurement) of the STA Satellite must be kept closed.
If opened the STA Satellite detects it and immediately stops ongoing tests.
Covers may only be opened during phases that allow it (eg: loading) and only when the
operator is asked to do so.
Do not obstruct switches detecting the presence of the covers.
For most of the screen displays available on the STA Satellite a printout of the information
is possible.

The screens of the analyzer may differ from the illustrations of this document.

Pictures are not contractual: the actual analyzer and its spare parts may differ from the
illustrations of this document.

In order to ensure a proper working of the analyzer, some components of the STA
Satellite have to remain at their initial location:
- the integrated printer
- the cuvette bin,
- the measurement cover,
- the needle head protection.

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Symbols and warnings

When the STA Satellite is running:


- do not put your fingers or any object in the needle tip protection groove in order not to
interfere with the arm movement.

Any interference may affect the efficiency of the analyzer.

When the red diode near the rinsing well is switched on:
- Do not make any change on the analyzer.

The switched on diode warns against the possible moves of the arm.

Make changes on the STA Satellite only during steps allowing these changes (ex:
loading).
(Since the needle tip is moving inside the cover, there is no biohazardous risk in case of
accidental impact).

DO NOT touch the cuvettes strip when the analyzer is on except during the recommen-
ded maintenance procedures

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RISK OF BIOLOGICAL CONTAMINATION


Connecting and disconnecting the waste container tubing:
Follow the safety precautions for the handling of biohazardous materials in accordance with
the local regulations in effect: use disposable gloves, mask and protective goggles.

Make sure that you connect the waste container tubing (red tubing) on the connection port

identified by the following red symbol:

Samples must be stored outside the STA Satellite as soon as their presence inside
the analyzer is no longer necessary.

Expiration date and lot number are not managed by the analyzer for the following products:
- STA®-OWREN KOLLER buffer (TOK),
- STA®-Desorb U solution,
- STA®-CaCl2 reagent.
The operator must therefore check the expiration date of these products before loading
them in the analyzer.
Seuls la stabilité et le volume sont gérés par l'instrument pour ces produits-
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.

1.6.1 Extended stop of the STA Satellite


If the analyzer has to be turned off for more than a week, follow the following procedure:

Follow the proper precautions for the handling of biohazardous materials in accordance
with the local regulations in effect: use disposable gloves, mask and protective
goggles.

" Remove all tubes and products.


" Remove all cuvettes containing plasma.
" Remove containers (used liquid and STA -Cleaner Solution).

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Symbols and warnings

" Eliminate waste containers (used liquid and cuvettes) in accordance with local
regulations in effect.
" Decontaminate the analyzer:
- Clean the needle and the cleaning well (see chap. 4.2.1)
- Clean the samples carousel and the products carousel (see chap. 4.2.3)
- Clean the measurement rail (see chap. 4.6.2)
- Clean the shield (see chap. 4.2.2)
- Clean the measurement covers, samples, products and needle rail (see chap. 4.2.7)
- Clean the bin (see chap. 4.6.1)

Eliminate any potentially bio-hazardous material according to local regulations.

Before switching the analyzer back on, put the liquid waste container and the cuvette roll
back in place, then, follow the same decontamination procedure.

1.6.2 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.

In accordance with Directive 2002/96/EC of January 27th, 2003 relating to WEEE, the
producers of WEEE are financially liable for the collection, treatment, recovery and
environmentally sound disposal of WEEE resulting from the equipment put on the market
after 13 August 2005, unless other agreements have been concluded between the producer
and the user or the distributor, planning ahead for either a partial or total transfer of
producer’s obligation and liabilities either to user or distributor.

For more information concerning the correct disposal of the STA Satellite , please contact
your local authority, the producer or the distributor.

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2 Introduction .............................................. 1

2.1 Definition . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

2.2 Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
2.2.1 Installation requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
2.2.2 Installation procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
2.2.3 Connecting peripherals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2

2.3 Principle of clotting methods . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

2.4 Principle of Photometric methods . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

2.5 General principles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7


2.5.1 Description of the analytical procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
2.5.2 Description of sample loading . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
2.5.3 Description of product loading . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
2.5.4 Description of the incubation measurement block . . . . . . . . . . . . . . . . . . . . 9
2.5.5 Description of the cuvette motion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

2.6 Technical specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10


2.6.1 Technical Specifications of the STA Satellite - Part 1 . . . . . . . . . . . . . . . . . 10
2.6.2 STA Satellite technical specifications - Part 2 . . . . . . . . . . . . . . . . . . . . . . . 12
2.6.3 STA Satellite technical specifications - Part 3 . . . . . . . . . . . . . . . . . . . . . . . 12
2.6.4 STA Satellite technical specifications - Part 4 . . . . . . . . . . . . . . . . . . . . . . . 14

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Introduction

2 Introduction
2.1 Definition
The STA Satellite system has been designed to perform in vitro tests for diagnosis and
monitoring of hemostasis conditions.
The STA Satellite system is a piece of medical equipment for in vitro diagnostic use that
comprises automated laboratory analyzer and software designed to be used together with
consumables and reagent products.

2.2 Installation

2.2.1 Installation requirements


Space requirements:

Height 794 mm 31.3 in.

Width 800 mm 31.5 in.

Depth 900 mm 35.4 in.

Power supply:

Voltage and tolerance 100 V (- 10 %) to 230 V (+ 10 %)

Frequency 50/60 Hz

Power consumption 500 W maximum

2.2.2 Installation procedure


The STA Satellite may only be installed by a representative of Diagnostica Stago or one of
its official distributors.

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Introduction

2.2.3 Connecting peripherals

Always switch off the STA Satellite before connecting:


- the host computer on the serial port
- optional elements: printer, screen, keyboard

Description of external connections:

Screen (optional)

Keyboard (optional)

Printer (optional)

Serial port
(connection to host computer)

Used liquid container


(red symbol)
(connection located below the serial port)

STA -Cleaner container


(black symbol)
(connection located below the serial port)

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Introduction

2.3 Principle of clotting methods


The principle consists in measuring the variation of the ball’s oscillation amplitude. A
decrease of the amplitude corresponds to an increase of the medium viscosity, i.e. to the
phenomenon of coagulation.
With constant viscosity, constant pendular swings of the ball are observed, thanks to two
curved rail tracks located at the bottom of the cuvettes and to the electromagnetic field
created alternatively on each side of the measurement head to maintain the swinging
motion. The field frequency is close to the natural oscillation frequency of the ball, ensuring
a very high system sensitivity.
For each measurement head:
" The magnetic field is created by two drive coils and is adjusted to the medium viscosity
and to the type of test (weak clot for Fibrinogen, normal clot for all the others.)
" Local Infra-red lighting allows light to penetrate the medium and minimizes the
interference of outside light.

" The motion of the balls is captured by a camera.

Fig. 1 - Principle of the measurement system

Légende :

1 Infrared lighting
2 Drive coil
3 Video camera

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If the plasma viscosity remains the same, ball motion stays constant. When viscosity
increases, due to coagulation, the oscillation amplitude of the ball motion decreases.
An algorithm uses these oscillation variation amplitudes to determine the clotting time.

Fig. 2 - Ball motion scheme

Légende :

The ball starts moving.


The chronometer starts.
Measurement of the oscillation variation amplitude of the ball is activated.

2.4 Principle of photometric methods


The detection of chromogenic or immunologic assays on the STA Satellite is based on the
absorbance (optical density: O.D.) of 405 nm monochromatic light (colorimetry) or of 540 nm
monochromatic light (immunology) passing through the cuvette while chromogenic reaction
takes place.
The principle of absorbance measurement is described in the diagram below.
The light (I) is the result of the incident light (I0) entering the cuvette is partially absorbed by
the reaction mixture as it passes through.
The transmitted light (I1 = I + Ip) is measured and converted into absorbance by the
following equation:

A = - Log (I1 /I0) Note: decimal logarithm

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Introduction

Fig. 3 - Principle of absorbance measurement

Stray light (Ip) is eliminated by taking two close measurements of the light transmitted:
I1 = I + Ip (first measurement, including incident light and stray light),
I2 = Ip (second measurement while blocking incident light, equals stray light).
When I2 is substracted from I1, the result I is the only quantity of light from the incident light.
It is assumed that stray light (Ip) remains the same between the two measurement.
The light is turned into monochromatic light by passing through a 405 nm, or a 540 nm
interference filter.
This step occurs in the optical module. A system of fiber optics carries the monochromatic
light from the optical module to the measurement heads. Another set of optical fiber carries
the transmitted light from the measurement head to the photometry measurement board
(see fig.4.)

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Introduction

Fig. 4 - Module operating principle

Légende :

1 Blue led
2 Green led
3 Measuring optical fiber
4 Reference optical fiber
5 Filter (405 nm)
6 Filter (540 nm)
7 1ntensity of the measurement channel
8 1ntensity of the reference channel
9 Analog / digital converter - 2 channels
10 Digital calculation of the optical density

The Beer-Lambert law is applied to the optical density measurements obtained:

A=εIC

A = Absorbance
e = Molecular exctinction coefficient
I = Optical path length
C = Concentration
Chromophore concentration measured is proportional to the absorbance.

All optical measurements are conducted according to the reference fiber.

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Introduction

2.5 General principles


The STA Satellite is an automated laboratory analyzer intended for analysis of
haemostasis. This analyzer can perform clotting tests (clotting time measurements) as well
as photometric tests - colorimetry (optic density measurement) and immunology (microlatex
method) - using plasma samples.

2.5.1 Description of the analytical procedure


Primary tubes are loaded into the sample carousel. Their location is identified by a Positive
Identification system.
The control, calibration, reagent vials and the dilution buffers are loaded into the product
carousel in which the temperature is maintained between 15°C and 19°C by a system based
on the Peltier effect. Their location is also identified by a Positive Identification system.
The plasma (sample, control or standard) is collected by the needle, using diluent if
necessary, and then distributed into a cuvette.
Intermediate reagents are added as needed (assay dependent).
Reagents to be dispensed after the first incubation (mainly the start reagents) are aspirated
by the needle and added to the cuvette.
Reagents requiring preheating are kept inside heating tube for about 2 seconds.
Between each distribution and sampling cycles, the inside and the outside of the needle are
rinsed in its cleaning well.
Once the measurement is done, the cuvette goes to the end of the rail where a cutter cuts
the cuvettes and drops it into the cuvette bin.

2.5.2 Description of sample loading


There are two types of loading:
ˆ The sample carousel can be totally or partially loaded outside the STA Satellite and put
back into the analyzer afterwards.
ˆ Loading can be conducted on a single basis by loading directly the tubes into the
analyzer.

After centrifugation, primary tubes are open and loaded into the sample carousel. Their
location is identified by the Positive Identification system.

Fig. 5 - Sample carousel

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The sample carousel barcode label is read, then the carousel moves to the front of the
loading zone so the tube label can be read. Once the tube label is read, the carousel turns
to position of the next tube to be read in the loading zone.
Thanks to the identification reading, the system is able to locate any tube inside the
analyzer.

When the STA Satellite is on, do not put your fingers inside the carousel except when
the analyzer is on loading or unloading mode.

2.5.3 Description of product loading


There are two types of loading:
ˆ The product carousel can be totally or partially loaded outside the STA Satellite and put
back into the analyzer afterwards.
ˆ Loading can be conducted on a single basis by loading the vials directly into the analyzer.

Any product required for testing must be loaded into the product carousel. Their location is
identified by the Positive Identification system.

Fig. 6 - Product carousel

The product carousel barcode label is read, then the carousel moves to the front of the
loading zone so the vial label can be read. Once the vial label is read, the carousel turns to
position of the next vial in the loading zone to be read.
Thanks to the identification reading, the system is able to locate any vial inside the analyzer.

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The product temperature is maintained between +15°C and +19°C.

When the STA Satellite is on, do not put your fingers inside the carousel except when
the analyzer is on loading or unloading mode.

2.5.4 Description of the incubation measurement block


The incubation zone and the measurement zone are both included in one block in which
temperature is maintained at 40 °C. A laminar resistance is used for heating.

2.5.5 Description of the cuvette motion


The reaction and measurement cuvettes are loaded into the STA Satellite in a roll
containing 220 units. Cuvette loading is continuous.
The cuvette strip circulates on a rail that brings cuvettes to the different areas of the process.
Given that all cuvettes are connected during the whole analytical cycle, each cuvette goes
through each area. As a result, a measurement may start in one area and finish in the next
area. When the cuvettes reach the end of the rail, they are cut off by a cutter above the
cuvette bin.

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2.6 Technical specifications

2.6.1 Technical Specifications of the STA Satellite - Part 1


Fig. 7 - STA Satellite , global view

Actual product may differ from the photograph


Légende :

1 LCD screen 7 Integrated printer


2 Cuvette roll 8 Cuvette bin
3 Cuvette roll support 9 Product carousel
4 Sample carousel 10 Sampling needle
5 Keyboard 11 Barcode reader
6 Arm 12 Bottle plate

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Type:
• Multi-parameter analyzer
• Operating mode: single patient or batch mode
• Clotting time, photometry (colorimetry and immunology)

Operating conditions:
• Impact resistance: in accordance with current standards
• Temperature: +15°C to +32°C (59°F to 89.5°F)
• Hygrometry: relative humidity 20 to 80%, non-condensing
• Altitude: <2 000 meters
• Internal use only

Storage and transport conditions:


• Storage temperature: -20°C to +60°C (-4°F to +140°F)
• Maximum temperature variation: 20°C (36°F) per hour
• Hygrometry: relative humidity 20 to 80%, non-condensing

Environment:
• Sound level: 63 dBA (maximum)
• Maximum sound pressure : 55 dBA (operator located in the front of the analyzer)
• Heat emission when room temperature is at 20°C : 500 W (1707 BTU)
• Pollution level: 2

STA Satellite dimensions:


• Height: 784 mm (30.9 in.)
• Width: 535 mm (21 in.)
• Depth: 645 mm (25.5 in)

STA Satellite weight:


• 32,6 kg (71.9 lb)

Space requirements:
• Height: 794 mm (31.3 in.)
• Width: 800 mm (31.5 in.)
• Depth: 900 mm (35.4 in.)

Electric power supply:


• Voltage and tolerance: from 100 V (- 10 %) to 230 V (+ 10 %)
• Frequency: 50/60 Hz
• Power consumption: 500 W
• Number of power sockets: 1
• Number of fuses: 7 FST Schurter 6.3A fuses - (5 x 20 mm)

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• Fuse protection: yes


• Inverter needed for micro-cuts: no
• Consequences of power outage: tests in process are discarded

2.6.2 STA Satellite technical specifications - Part 2


Standards:
• CE mark (in accordance with 98/79/CEE and 73/23/CEE directives changed by the 93/
68/CE directive)
- EN 61326-2-6 (Class A for emissions and industrial immunity)
- EN 61010-1
- EN 61010 - 2 - 101
• - UL 61010 - 1
- FCC Part 15
Classification:
• Type of protection against electric shocks: class 1 equipment
• Degree of protection against penetration of water: regular equipment (enclosed
equipment with no protection against penetration of water)
• Disinfection method recommended: see procedure in chap. 4.8.1.
• Degree of safety application: equipment not suitable for use in the presence of flammable
anesthetic mix with air, oxygen or nitrous oxide.
• Operating mode: continuous operation

All devices connected to the STA Satellite must comply with CEI 60950, EN 55022 class B
and EN 55024 standards.

2.6.3 STA Satellite technical specifications - Part 3


Sample management:
• Primary centrifuged tubes: uncapped with or without barcode label:
- Diameter: 13 mm (5 ml) - (0.51 in.)
- Length: 75 mm (2.95 in.)
Use of adapters (provided with the analyzer) for microtainer

- For optimal barcode reading, the use of mat labels is recommended.

• 20 tube carousel
• Positive Identification
• Barcode reader

Product management
• Carousel with 16 positions of different sizes:
- 4 positions for 10/15/20 ml vials (diam. 30 mm)

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- 12 positions for 4/6 ml vials (diam 23 mm)


Use of adapters (provided with the analyzer) for 18 mm diameter vials

You must only use adapters provided with the STA Satellite .

• Positive identification
• Barcode reader
• Temperature control (between 15°C and 19 °C)
• Stability and volume management

Products: controls, calibrators, reagents, diluents and decontamination solution.

Measurement principle:
• Analytical modes: clotting and photometry
• Clotting: change in medium viscosity detected by a video camera
• Photometry:
- Light source: photodiodes
- Application in colorimetry and immunology: measurement of the optical density at 405
nm and 540 nm

Methodology:
• 80 methodologies

Pipetting units:
• Collected volumes: 25 µl to 200 µl

Cuvettes:
• Assembled in rolls of 220 cuvettes with built-in stainless steel balls
- Maximum usable volume: 400 µl
- Minimum usable volume: 150 µl for chronometry and 250 µl for photometry

Patents:
• Mini automated laboratory analyzer
Patent number:
- WO9964839

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Performance:
• Intra-test repeatability using Diagnostica Stago products:

Normal plasmas Abnormal plasmas

PT (sec) < 1,5 % <2%

APTT (sec) < 1,5 % <2%

Fibrinogen (sec) <4% <5%

2.6.4 STA Satellite technical specifications - Part 4


Integrated PC:
• Microprocessor: 486 DX4 100 MHz
• Memory: 8 MB (Minimum)
• Hard disk: Compact flash 64 Mo
• Floppy disks: 3’’1/2
• Operating system: DOS
• Connection plugs for an external screen, standard external keyboard, external printer

Computer connection:
• Interface serie RS232C
• Protocole ASTM

Screen:
• Integrated LCD color video screen

Keyboard:
• Integrated alphanumeric keyboard with contextual keys

Printer:
• Integrated thermal printer

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3 Preparation of the STA Satellite ......................... 1

3.1 Verifications prior to turning on the STA Satellite® . . . . . . . . . . . . 1

3.2 Turning on the STA Satellite® . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2


3.2.1 Deleting old files . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
3.2.2 How to access the TEST PANEL . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

3.3 TEST PANEL . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3


3.3.1 TEST PANEL description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

3.4 Cuvette roll loading . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7


3.4.1 Accessing CUVETTE ROLL CHANGE window . . . . . . . . . . . . . . . . . . . . . . . . . 7
3.4.1.1 Accessing CUVETTE ROLL CHANGE window from the error window . . . . . . . . . . . . . . . 8
3.4.1.2 Accessing CUVETTE ROLL CHANGE window from the TEST PANEL . . . . . . . . . . . . . . . . 8
3.4.2 Removing the empty roll . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
3.4.3 Installing the new cuvette roll . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

3.5 Change of the cuvette bin . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12


3.5.1 Emptying used cuvette bin (change of disposable bin) . . . . . . . . . . . . . . . . . 13
3.5.2 Installation of the disposable cuvette bin . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

3.6 Loading the washing solution . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14


3.6.1 Accessing the WASHING SOLUTION LOADING window . . . . . . . . . . . . . . . . 16
3.6.1.1 Accessing the WASHING SOLUTION LOADING window from the error window . . . . . . . 16
3.6.1.2 Accessing the WASHING SOLUTION LOADING window from the TEST PANEL . . . . . . . . 17
3.6.2 Removal of the used liquid container . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
3.6.3 Installation of the used liquid container . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
3.6.4 Installation of the new washing solution container . . . . . . . . . . . . . . . . . . . 21

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3.7 Power-off procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22


3.7.1 Reminders . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
3.7.2 Power-off procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22

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3 Preparation of the STA Satellite


3.1 Verifications prior to turning on the STA Satellite®
Before turning the STA Satellite on, check that:
- The integrated printer is in its location with the paper source in position
(only for STA Satellite equipped with a removable integrated printer).
In case an external printer is used, turn it on.
- The cuvette bin is located underneath the cutter (on the right side of the analyzer).
- The needle head protection is in position (see figure 22, chap. 4.7.2).
- The rail cover is in position (see figure 5, chap. 4.2.7).
Before using the STA Satellite , check that:
- The bottle plate is located on the left side of the analyzer.
- The sample and product covers are closed.

Check that nothing obstructs the ventilation, especially the areas above the screen and
beneath the analyzer.

3.2 Turning on the STA Satellite®


The STA Satellite is designed to operate 24 hours a day.

ACTIONS RESULTS

" Switch the STA Satellite on (I)  The STA Satellite starts
This switch is located on the right side of
 The STA Satellite carries out software
the STA Satellite
and automation checks
If the STA Satellite detects a problem,
an error window is displayed according
to the problem found
 The GLOBAL VERIFICATION DONE
message is displayed:

with the cursor on Continue

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ACTIONS RESULTS

" Wait for 30 minutes in order for the  The STA Satellite is ready to be used
temperature of the product carousel to
become stable

3.2.1 Deleting old files


2GLOBAL VERIFICATION DONE window is diplayed with the cursor on Continue.

Verify that all patient files have been transmitted and/or printed before executing this step.
There is no possible selection here. All files in the Working File will be deleted if this option
is chosen. To only partially delete the Working File, go to the TEST PANEL, and then see
chap. 8.6.

ACTIONS RESULTS

" Press until Delete the Working File  The following window appears:
and confirm with Enter.

" Press the Y key to confirm deletion  The following window is displayed:

All the patient files in the Working File will


be deleted.

with the cursor on Continue


Note: Delete the Working File is
displayed in grey, this option is no longer
available
 All the files in the Working file are
deleted

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3.2.2 How to access the TEST PANEL


2The GLOBAL VERIFICATION DONE WINDOW is displayed, with the cursor on Continue.

ACTIONS RESULTS

" Press the Enter key  The Product loading menu is displayed

" Initiate product loading (see chap. 6.3)  TEST STATUS window is diplayed

" Press the Esc key  The TEST PANEL is displayed

3.3 TEST PANEL


The TEST PANEL is an essential screen of the STA Satellite .
The TEST PANEL screen enables the user to:
- monitor in real time the progress of the tests for each Patient File (loaded tubes)
- process a file selected with the cursor (validation, printout, transmission)
- access the FILE MODIFICATION screen
- display the Main Menu

It is also the return point menu from all other STA Satellite menus.

3.3.1 TEST PANEL description

Fig. 1 - TEST PANEL screen

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Legend:

1 Available keys:

Use this key to display the next tests ( ) or the previous tests ( )

Use this key to display the next files ( ) or the previous files ( )

Use this key to initiate patient file processing: add, delete tests, etc. (see
description in chap. 8.3)

F9 Options ; use F9 key to access:


- the help screen which describes color codes used in the TEST PANEL screen
- the FILE MODIFICATION screen used to block / unblock, rerun or
delete one or several tests from any files in the Work File (see description in
chap. 8.7)

F11 Download of working lists


With F11 key, it is possible to request the worklist from the host computer for all
tubes already loaded and which have not received their list during loading (see
description
in chap. 8.9)

Esc Use Esc key to display the Main Menu:

F1 Allows sample loading as long as the Main Menu


is not displayed (key not documented on the screen).

F2 / F3 Allows product loading as long as the Main Menu


is not displayed (key not documented on the screen).

2 Screen name
3 Identification of patient files: a color code shows status:
White: Normal
Yellow: STAT sample
Grey: File for which a tube has been loaded but the list of tests is unknown (waiting for
downloading from the host computer)
Green: A liquid level detection problem has been detected
Red: An error has been detected in one or several tests (see description in zone 7)
"Patient" files are classified by chronological order of creation
4 Position occupied by each tube within the sample carousel. The μ symbol is displayed
after the tube is installed into the carousel if the microvolume option has been chosen

5 Abbreviated name for each test

6 Primary unit for obtained results defined in the test setup (see chap. 5.1.1.7)

7 Zone for result display: several codes show test status:

"xxx.x" displayed in black: Test requested, pending

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"− − − −" displayed in black: Test in progress

"− − −.−" displayed in red: Rerun test, for instance, after a technical error (no
ball detected...), or after detection of a time shorter
than the min. time (<V.min.) or longer than the max.
time (> V.max.)

Result displayed in black: Technically correct result (validated or to be


validated)

Result displayed in blue: Result obtained after redilution

Result displayed in dark red: Error on the result (deviation > tolerance)

Result displayed in light red: Result obtained with an out of range quality control or
with no quality control

"Block." displayed in dark red: Test blocked from FILE MODIFICATION screen (see
description in chap. 8.7)

"Err." displayed in dark red: Technical error

"> V max". displayed in dark For all clotting tests; raw measurement is greater
red : than the maximum time defined in the TEST SETUP
screen (see chap. 5.1.1.6).
For calibration modes: graphic 2nd order polynomial
or graphic 3rd order polynomial, raw data (sec.,
ΔO.D. or O.D./min) higher than raw data obtained for
the highest calibration point.
For immunological tests in kinetic 2-points with
calibration mode: 2nd order polynomial or 3rd order
polynomial, after redilution using the parameter
"Dilute further" (if over limit) (see description in
chap. 5.1.1.6) value obtained once again out of
range.

"< V min". displayed in dark For clotting tests, raw measurement less than the
red : minimum time, defined in the TEST SETUP screen(see
chap. 5.1.1.6)
For calibration modes: graphic 2nd order polynomial
or graphic 3rd order polynomial, the raw data
obtained (sec., ΔO.D. ou O.D./min) is lower than the
raw data obtained for the lowest calibration point

"Lin" displayed in dark red : Insufficient linearity regarding photometric tests


(see chap. 5.1.1.6)

"QNS" displayed in dark red: Quantity of plasma not sufficient

Note: For results displayed in the TEST PANEL, the printout limits have not been applied (see
description in chap. 5.1.3.3)

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8 The message "BLOCKED SAMPLE PIPETTING" is displayed in white at the bottom of the
screen on a red background when the sample pipetting is blocked, whether:

- Intentionally by the operator (Stop Sample Pipetting function, see description in


chap. 10.1.5.1
- or automatically by the STA Satellite if, after consistency check, assays cannot be
performed.

The TEST PANEL allows the display of additional information about the patient (name, first
name, etc.) when the cursor is positioned on his/her file (see description in
chap. 10.2.3.3).

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3.4 Cuvette roll loading


Cat.No.: 39430
To change a cuvette roll, the operator must:
" First, access the CUVETTE ROLL CHANGE window
" Second, remove the empty roll
" Third, install the new cuvette roll

Only handle the cuvette strip when in the CUVETTE ROLL CHANGE mode (see chap. 3.4.1.1
and 3.4.1.2).
Any handling except in this mode is forbidden.

After changing the cuvette roll, the cuvette bin must systematically be emptied
(see chap. 3.5)

3.4.1 Accessing CUVETTE ROLL CHANGE window


There are two ways to access CUVETTE ROLL CHANGE window:
- From an error window
- From the Main Menu, from the TEST PANEL screen

An error window will be displayed automatically when the cuvette roll is empty.

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3.4.1.1 Accessing CUVETTE ROLL CHANGE window from the error window
2 The following window is displayed:
CUVETTE FEED
Cuvette missing
Esc = Continue F1: Load

ACTIONS RESULTS

" Press F1 key to load the new cuvette  The following window is displayed:
roll

If this window is not displayed, press the


Esc key to go back to the TEST PANEL

" Proceed roll change (see the following)

3.4.1.2 Accessing CUVETTE ROLL CHANGE window from the TEST PANEL
2 TEST PANEL SCREEN displayed.

ACTIONS RESULTS

" Press the Esc key  The Main menu is displayed:

with the cursor on Status

" Press the L key (Loading)  The Loading menu is displayed:


OR
" Press the key until you reach
Loading, then confirm with Enter

with the cursor positioned on Samples.

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ACTIONS RESULTS

" Press the C key (Cuvettes)  A load guide window is displayed:


OR
" Press until you reach Cuvettes, then
confirm with Enter

CUVETTE ROLL CHANGE PROCEDURE:

" Remove the support with the empty  The following window is displayed:
cuvette roll from the STA Satellite
(see chap. 3.4.2)
" Confirm with the F10 key

" Install the new cuvette roll in its support  Cuvettes are correctly placed into the
(see chap. 3.4.3) loading rail
" Put the support with the new roll back  The following window is displayed:
in its place on the STA Satellite
(see chap. 3.4.3 below)
" Confirm by pressing the F10 key

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ACTIONS RESULTS

" Confirm the number of cuvettes with  The following window is displayed:
the Enter key if a new cuvette roll is
used
" Otherwise, type the number of cuvettes
left and confirm with the Enter key

Contaminant products: observe precautions


regarding the use of potentially
contaminated products

" Change the cuvette bin according to the


procedure described in chap. 3.5
" Confirm with the F10 key

3.4.2 Removing the empty roll

During this procedure, do NOT lift the cover of the measurement rail. If the cover is lifted,
the STA Satellite stops immediately.

" Take out the roll support from its location by lifting it up.
" Take out the empty roll from its support (see fig. 2), and throw it away.

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Fig. 2 - Cuvette roll support

3.4.3 Installing the new cuvette roll

Do not use used cuvettes. The use of used cuvettes would distort results.
Never insert a cuvette strip that contains less than 5 cuvettes.

During this procedure, do NOT lift the cover of the measurement rail. If the cover is lifted,
the STA Satellite stops immediately.

" Place the new roll by passing the cuvette strip behind the axis support (see fig. 3).
" Unroll the cuvette roll until the limit show in figure 4.
" Replace the support with the new cuvette roll back in its place.
" Make sure to leave a minimum space of two cuvettes from the previous cuvette strip.
" Confirm with the F10 key.

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Fig. 3 - Axis location in the roll support

Legend:

1 Axis

Fig. 4 - Installation of the new roll

Legend:

1 Cuvette roll support

2 Cuvette roll limit

3.5 Change of the cuvette bin

RISK OF BIOLOGICAL CONTAMINATION


Each time the cuvette roll is changed, the cuvette bin must be systematically emptied. The
cuvette bin contains potentially biologically hazardous material. It must be discarded
according to local regulations.

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RISK OF INJURY
Do not introduce your hand or part of your hand in this area when the analyzer is ON.

3.5.1 Emptying used cuvette bin (change of disposable bin)


" Take out the cuvette bin from the STA Satellite by pulling it to the right.
" Put the cuvette bin on a flat and stable surface.
" Take a disposable bin cover.
" Clip the cover on the disposable bin (see fig. 5).

Fig. 5 - Installation of the disposable bin cover

" Take out the disposable bin by pulling it up (see fig. 6).

Fig. 6 - Removal of the disposable bin

" Discard the disposable bin and its content according to local regulations in effect.

If you notice that the cuvette bin is dirty (presence of plasma, presence of used cuvettes,...)
proceed to the cleaning of the bin according to procedures described in chap. 4.6.1.

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3.5.2 Installation of the disposable cuvette bin


" Take a new disposable bin.
" Insert the disposable bin into the bin.
" Replace the cuvette bin with the new disposable bin in place, make sure the bin is
pushed in as far as it will go.
" Press F10 to confim the cuvette bin replacement.
 Back to the TEST PANEL.

3.6 Loading the Washing solution


Ref.: 00973 (STA - Cleaner Solution)
To replace the Washing solution, the operator has to:
1 Access the WASHING SOLUTION LOADING window

2 Remove the waste container

3 Move the empty solution container

4 Replace the new STA - Cleaner Solution container

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RISK OF BIOLOGICAL CONTAMINATION


Manipulation of biohazardous material: for all the operations described below, observe
local regulations in effect: use disposable gloves, mask and protective goggles.

RISK OF BIOLOGICAL CONTAMINATION


To complete this procedure, please notice the position of the bottle plate !

Follow the displayed procedure


(In accordance with the location specified on
the opposite figure and the indications written
on the labels)

Reposition the bottle plate as shown on the


figure above and follow the displayed
procedure.
OR
Please note the bottle plate position before
completing the procedure !
In this case, the right container on the screen
corresponds to the left container of the bottle
plate.

In the event of error (containers inversion), follow the decontamination procedure


(see chap. 4.6.6).

Legend:

1 Used liquid container (full)

2 Container of STA Cleaner solution (empty)

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3.6.1 Accessing the WASHING SOLUTION LOADING window


There are two ways to access the WASHING SOLUTION LOADING window:
- From an error window,
- From the Main Menu, from the TEST PANEL.

Before following the procedure described below, make sure the bottle plate is located on
the left side, below the analyzer.

3.6.1.1 Accessing the WASHING SOLUTION LOADING window from the error window
2 The following error window is displayed:

Risk of waste liquid overflow if the operator does not observe this warning.

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ACTIONS RESULTS

" Press the F1 key to change the  The following window is displayed:
Washing solution

Biohazardous material: observe


precautions of use regarding potentially
contaminated products

" Proceed loading of the Washing


solution (see below)

3.6.1.2 Accessing the WASHING SOLUTION LOADING window from the TEST PANEL
2 TEST PANEL screen is displayed.

ACTIONS RESULTS

" Press the Esc key  The Main Menu is displayed:

with the cursor on Status.

" Press the L key (Loading)  The following menu is displayed:


" OR press the key until you reach
Loading, then confirm with the Enter
key

with the cursor on Samples

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ACTIONS RESULTS

" Press the W key (Washing solution)  The Washing solution loading guide
window is displayed:
" OR press the key until you reach
Washing solution, then confirm with
the Enter key

Biohazardous material: observe


precautions of use regarding potentially
contaminated products

" Proceed by unloading the used liquid  The following window is displayed:
container (see chap. 3.6.2)
" Press the F10 key to confirm the end of
the process

" Place the new liquid container (see  The following window is displayed:
chap. 3.6.3)
" Press the F10 key to confirm the end of
the process

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Preparation of the STA Satellite

ACTIONS RESULTS

" Load the new STA - Cleaner Solution  The following window is displayed:
container (see chap. 3.6.4)

" Confirm the volume contained in the  Back to the Test Status menu
STA - Cleaner Solution container if the
container used is new
" Otherwise, notify the volume remaining
" Press the Enter key to confirm

3.6.2 Removal of the used liquid container

RISK OF BIOLOGICAL CONTAMINATION


The used liquid container contains biohazardous material and must therefore be discarded
according to the local regulations in effect.

When connecting and disconnecting container, observe color codes:


- red tube for the used liquid container,
- clear tube for the STA -Cleaner Solution container.

2The WASHING SOLUTION LOADING help window is displayed with the following message:
"Please remove and throw away this bottle".

When disconnecting the used liquid container, the bottle plate must be located at a lower
level than the STA Satellite .

" Remove the bottle plate handle and the used liquid container cap.

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" Carefully lift the used liquid container represented in yellow color on the help screen.
" Then, remove the used liquid container.
" Press the F10 key to confirm the end of the process.
" Replace the original cap on the used liquid container.
" Discard the used liquid container according to the local regulations in effect.

Make sure to identify the used liquid container, do NOT use it as a new STA - Cleaner
Solution container, this could lead to inaccurate results.

3.6.3 Installation of the used liquid container

When connecting and disconnecting containers, please observe the color codes:
- red tube for the used liquid container,
- clear tube for the STA -Cleaner Solution container.

The empty STA - Cleaner Solution container is used as a new liquid waste container.

2The WASHING SOLUTION LOADING help screen is diplayed with the following message:
"Please EMPTY then displace this bottle.
" Remove the cap of the STA -Cleaner Solution empty container (left container).
Avoid possible contamination of the tube by placing its end into a container.
" Carefully lift the STA -Cleaner Solution container.
" If necessary, discard any remaining STA - Cleaner Solution.
" Place the empty container in the used liquid container location.
" Put the cap (red tube) on the empty container.

Do not obstruct the sensor that allows the STA Satellite to detect the presence of the used
liquid container.

" Press the F10 key to confirm the end of this process.

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Preparation of the STA Satellite

3.6.4 Installation of the new washing solution container

In case the used liquid container and the Washing solution container are inverted:
- Immediately discard the STA - Cleaner Solution container that may be contaminated.
- Decontaminate the fluid system (see chap. 4.2.1)

2The WASHING SOLUTION LOADING help screen is displayed with the following message:
"Please install a new bottle.
" Take a new STA - Cleaner Solution container.

The new STA - Cleaner Solution bottle must be at room temperature.

RISK OF INCORRECT RESULTS


Do not modify the solution formulation, this could lead to wrong results.

" Remove the lid.


" Place the STA - Cleaner Solution container in its seating.
" Place the cap (white tube) on it.

Do not obstruct the sensor that allows the STA Satellite to detect the presence
of the liquid bin.

" Press the F10 key to confirm the end of the process.
" Confirm the indicated volume (2 500 ml) with the Enter key if a new container is used.
Otherwise, enter the volume left and confirm with Enter.

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3.7 Power-off procedure

3.7.1 Reminders
The STA Satellite monitor automatically switches off after 20 minutes, even if the STA
Satellite is operating measurements. If an error is detected, an audible alarm is emitted.
When all tests are completed, the STA Satellite switches to a stand-by mode. All automatic
functions stop except for the temperature regulations.
If some reagents are still present inside the STA Satellite , it is recommended to leave them
inside; the STA Satellite automatically manages the product stability.
To stop temporarily sample pippeting, use the Stop Sample Pipetting function (see
description in chap. 10.1.5.1).

3.7.2 Power-off procedure


" Unload all tubes from the sample carousel, see chap. 6.6.
" Unload all vials from the product carousel, see chap. 6.6.

2TEST PANEL screen is displayed.

ACTIONS RESULTS

" Press the Esc key  The Main Menu is displayed:

with the cursor on Status

" Press the H key (Halt)  The following window is displayed:


" OR press the key until you reach
Halt, then confirm with the Enter
key

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Preparation of the STA Satellite

ACTIONS RESULTS

" Press the Y key (Yes)  Saving of the analyzer status


 The following window is displayed:

 Then, this window is replaced by the


following window:

" Switch the STA Satellite off (O).  The STA Satellite stops.
The On/Off switch is located on the
right side of the STA Satellite .

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4 Maintenance .............................................. 1

4.1 Preventive maintenance schedule . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

4.2 Weekly preventive maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2


4.2.1 Cleaning of the needle and of the washing well . . . . . . . . . . . . . . . . . . . . . . . 2
4.2.2 Cleaning the shield . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
4.2.3 Cleaning the product and sample carousels . . . . . . . . . . . . . . . . . . . . . . . . . . 8
4.2.4 Cleaning samples and products compartments . . . . . . . . . . . . . . . . . . . . . . . 8
4.2.5 Cleaning the rail . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
4.2.6 Cleaning the rail glass . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
4.2.7 Cleaning the rail, sample and product covers and the needle passage . . . . 14
4.2.8 Cleaning the optical sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
4.2.9 Cleaning of the covering . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
4.2.10 Cleaning the monitor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16

4.3 Monthly preventive maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17


4.3.1 Cleaning of air filters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17

4.4 Quarterly preventive maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . 19


4.4.1 Change of the air filters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

4.5 Yearly preventive maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19


4.5.1 Change of the needle . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

4.6 Curative maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20


4.6.1 Cleaning the cuvette bin . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
4.6.2 Cleaning the rail and dismantling the cuvette guiding . . . . . . . . . . . . . . . . . 21
4.6.3 Procedure after a rewinding of the cuvette roll . . . . . . . . . . . . . . . . . . . . . . 24
4.6.4 Manual moving of the cuvette strip (STA Satellite turned off) . . . . . . . . . . 26

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4.6.5 Cleaning the product glass . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27


4.6.6 Decontamination procedure for STA Cleaner Solution and waste container 29
inversion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29

4.7 Component replacement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33


4.7.1 Replacement of the air filter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
4.7.2 Replacement of the needle . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
4.7.3 Fuse replacement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45
4.7.4 Replacement of integrated printer thermal paper . . . . . . . . . . . . . . . . . . 47

4.8 Decontamination process . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48


4.8.1 Preparation of the decontamination solution . . . . . . . . . . . . . . . . . . . . . . . . 48

4.9 Maintenance Utilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49


4.9.1 Access the User Maintenance Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51
4.9.2 Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52
4.9.2.1 Needle replacement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52
4.9.2.2 Rinsing and Purge . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53
4.9.2.3 Dates of recent maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54
4.9.2.4 Quit the Maintenance Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55
4.9.3 Internal printer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55
4.9.3.1 Access the internal printer menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55
4.9.3.2 Connection check . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56
4.9.3.3 Character set testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57
4.9.3.4 Graph . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58
4.9.4 External printer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59
4.9.4.1 Connection checking . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59
4.9.4.2 Character set testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60
4.9.4.3 Graph . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61
4.9.4.4 Quit the PRINTER menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62
4.9.4.5 External printer setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62
4.9.5 Saving . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63
4.9.5.1 How to access Saving menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64
4.9.5.2 Item selection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65

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4.9.5.3 Rereading .................................................... 66


4.9.5.4 Saving . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68
4.9.5.5 Floppy disk formatting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 70
4.9.5.6 Device status . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 71
4.9.5.7 Quit the Save/reread the parameters menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 72
4.9.6 TDEX utility program (Data processing export of patient’s results) . . . . . . 72
4.9.7 Host Computer communications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 74
4.9.8 Barcode reader . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 74
4.9.8.1 Information display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75
4.9.8.2 Reading test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 76
4.9.9 Error History . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 76
4.9.9.1 How to access the ERROR LOG menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 76
4.9.9.2 Parameter selection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77
4.9.10 Data update . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 78
4.9.11 Photometry graphics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 80
4.9.11.1 Accessing the photometry graphics menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 80
4.9.11.2 Removing points . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 83
4.9.11.3 STA Satellite Calculation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 83
4.9.11.4 Curve printout . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 84
4.9.11.5 Measurement printout . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 84
4.9.11.6 Window modification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 84
4.9.11.7 Other patient . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 85
4.9.11.8 Quitting the photometry graphics menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 85
4.9.12 Language Setting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 86
4.9.13 Users management . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 86
4.9.13.1 Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 86
4.9.13.2 Accessing the users management menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 90
4.9.13.3 Creating a user . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 91
4.9.13.4 Deleting a user . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 92
4.9.13.5 Accessing a STA Satellite protected function . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 92
4.9.14 Changing the system date and time . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 93
4.9.14.1 Changing the date . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 93
4.9.14.2 Changing the time . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 94
4.9.15 Return to the main menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 95

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4
Maintenance

4 Maintenance
4.1 Preventive maintenance schedule
This schedule is given as an example, it must be adapted to the laboratory activity.

FREQUENCY TYPE OF MAINTENANCE

Weekly Cleaning the needle and the washing well


Cleaning the shield
Cleaning the carousels
Cleaning the sample and product compartments
Cleaning the rail
Cleaning the rail glass
Cleaning the rail, sample and product covers and the
needle passage
Cleaning the optical sensor
Cleaning the covering
Cleaning the monitor

Monthly Cleaning the dust filters

Quarterly Replacing the dust filters

Yearly Replacing the needle


Preventive maintenance visit by your local authorized
Service Representative

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4.2 Weekly preventive maintenance

4.2.1 Cleaning of the needle and of the washing well

Weekly maintenance
Purpose:
- Cleaning of the needle: the external cleaning of the needle has to be done every 300
tests or at least once a week.

- Cleaning of the cleaning well and fluidic circuit is performed to ensure good suction and
avoid external contamination of the needle. The cleaning well should be cleaned once a
week..

The STA® Desorb U used for this operation is 1,3ml.


The needle takes 1 ml to do the decontamination of the cleaning well and of the external
part of the needle. The 300 µl are used to decontaminate the internal part of the needle.

RISK OF BIOLOGICAL CONTAMINATION


Observe precautions of use regarding the handling of biohazardous products, according to
the local regulations in effect: use disposable gloves.

2Test panel screen is displayed


ACTIONS RESULTS

Access the User Maintenance menu  The Main menu is displayed:


" Press the Esc key

with the cursor on Status

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Maintenance

ACTIONS RESULTS

" Press the brightening key:  The User Maintenance menu is


Maintenance displayed:
" or press the key until you reach
Maintenance, then press the Enter key
to confirm

with the cursor on Maintenance.

" Press the Enter key to access the  The following menu is displayed:
Maintenance Menu

 with the cursor on Rinsing and purge

Press the Enter key to access the  The Rinsing and Purge menu is
Rinsing and purge menu displayed:

with the cursor on Rinse the needle

Access the Decontaminate needle and  The following window is


well menu displayed:
" Press the key until you reach
Decontaminate needle and well, then
press the Enter key to confirm

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Maintenance

ACTIONS RESULTS

" Open the product cover and unload the  The following window is
current product from position 1 of displayed:
product carousel
" Press any key

" Load a new STA® Desorb U vial in  Arm initialization is processed while the
position 1 of product carousel following window is displayed:
" Close the product cover
" Press any key

 Product carousel initialization is


processed while the following window is
displayed:

 The needle aspirates some STA®


Desorb U and goes down into the well.

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Maintenance

ACTIONS RESULTS

 The following window indicating the


decontamination countdown is
displayed:

 At the end of the decontamination


process, the following window is
displayed:

" Open the product cover and unload the  The following window is displayed:
STA® Desorb U vial from position 1 of
product carousel
 Wipe the black conical part of the
needle with absorbant paper
" Press any key

" Close the product cover  The Rinsing and purge menu is
displayed:
" Press any key

Access the Rinse the needle menu  Rinsing of the needle


" Press the Enter key to confirm

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Maintenance

ACTIONS RESULTS

Access the Purge the fluidic circuit  Purge of the fluidic system
menu
" Press the key until you reach Purge
the fluidic circuit, then press the Enter
key to confirm

Quit the Rinsing & Purge screen  The User Maintenance menu is
displayed
" Press the key until you reach Return
to previous menu, then press the
Enter key to confirm

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Maintenance

4.2.2 Cleaning the shield


Weekly maintenance
Purpose: Avoid dirtiness.

RISK OF BIOLOGICAL CONTAMINATION


Observe the precautions of use regarding the handling of biohazardous products according
to the local regulations in effect: use disposable gloves.

" Turn the STA Satellite off.


" Remove the rail cover.
" Swivel the flange (transparent washer - see fig. 1 - mark 1) round to release the shield
(see fig. 1 - mark 2).
The flange should no longer cover the shield (see fig. 2).

Fig. 1 - Location of the flange and the shield

Legend:

1 Flange (transparent washer)


2 Shield

" Remove the shield (see fig. 3).

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Fig. 2 - Removing the flange Fig. 3 - Removing the shield

" Place the shield into a container filled with a decontamination solution.
(see chap. 4.8.1).
" Soak the shield in the decontamination solution for 15 minutes.
" Remove the shield from the container.
" Rinse the shield.
" Dry the shield.
" Put back the shield by placing the notch on the right side (see fig. 4 - mark 1).

Fig. 4 - Installation of the shield

Legend:

1 Notch of the shield (located on the right side).

" Swivel the flange round to hold the shield in place.


" Put back the rail cover.
" Turn the STA Satellite back on.

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4
Maintenance

4.2.3 Cleaning the product and sample carousels


Weekly maintenance

RISK OF BIOLOGICAL CONTAMINATION


Observe the precautions of use regarding the handling of biohazardous products according
to the local regulations in effect: use disposable gloves.

It is recommended to use water with detergent when washing carousels (for example: 4,8%
sodium hydroxide solution).
Carousels may also be washed in the dishwasher.

RISK OF BIOLOGICAL CONTAMINATION


If a sample tube breaks, wash the carousel with a decontamination solution
(see chap. 4.8.1).

4.2.4 Cleaning samples and products compartments


Weekly maintenance
Purpose: Avoid dirtiness

RISK OF BIOLOGICAL CONTAMINATION


Observe the precautions of use regarding the handling of biohazardous products according
to the local regulations in effect: use disposable gloves.

" Lift the sample cover up.


" Remove the sample carousel from its compartment and put it on a flat surface.
" Clean the compartment with a cloth or with some absorbent paper moistened with hot
water.
" Wipe with a dry cloth.
" Replace the sample carousel.
" Close the cover.
" Make sure the cover is closed.

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" Proceed the same way for the product carousel.

Make sure to place the carousels properly in their respective compartments.

4.2.5 Cleaning the rail


Weekly maintenance

RISK OF BIOLOGICAL CONTAMINATION


Observe the precautions of use regarding the handling of biohazardous products according
to the local regulations in effect: use disposable gloves.

RISK OF BIOLOGICAL CONTAMINATION


Handle and eliminate the used cuvettes according to the local regulations in effect.

Purpose: Avoid dirtiness and allow a good movement of the cuvette along the rail.
" Turn the STA Satellite off.
" Remove the rail cover located behind the arm of the analyzer (see fig. 5).
" Remove the shield (see chap. 4.2.2).
" Remove the cuvette roll by driving the belt manually.
" Remove the cuvette roll and its support.

RISK OF INCORRECT RESULTS


RISK OF BIOLOGICAL CONTAMINATION
Do not introduce used cuvettes in the rail:
" Use scissors to cut off the damaged part or/and the part with used cuvettes of the
cuvette strip.
" Eliminate biohazardous material according to the local regulations in effect.
" Decontaminate the scissors by placing them into the decontamination solution for 15 mn
(see chap. 4.8.1)

" Place the cuvette roll and its support on a flat surface.
" Remove the used cuvettes from the rail and eliminate them according to the local
regulation in effect.

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Maintenance

" Carefully clean the rail with a Q-tip moistened with hot water.

Avoid touching electronic cards.

" Replace the cuvette roll on its support after checking the cuvette strip.

Fig. 5 - Rail

Legend:
1 Electronic card

2 Rail cover

3 Rail

" Replace the shield (see chap. 4.2.2).


" Replace the rail cover.

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" Turn the STA Satellite back on.


When the following message is displayed:

" Press the Esc key to quit the error message.


The following window is displayed:

" Press the Enter key (cursor on Continue).


" If necessary, load products (see procedure chap. 6.3).
" When the following window is displayed:

" Press the F10 key.


" Replace the cuvette roll with its support and continue loading according to the
procedure described chap. 3.4 by simulating the change of the cuvette bin.

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Maintenance

4.2.6 Cleaning the rail glass


Weekly maintenance
The rail window should be cleaned every 300 tests or at least once a week.

RISK OF BIOLOGICAL CONTAMINATION


Observe the precautions of use regarding the handling of biohazardous products according
to the local regulations in effect: use disposable gloves.

RISK OF BIOLOGICAL CONTAMINATION


Handling and eliminating the cuvettes contaminated by biohazardous products according
to the local regulations in effect.

Purpose: Avoid dirtiness of the glass to insure a good quality image of the camera.
" Turn the STA Satellite off.
" Remove the rail cover located behind the arm of the analyzer (see fig. 5).
" Remove the shield (see chap. 4.2.2).
" Remove the cuvette strip by driving the belt manually.
" Remove the cuvette roll and its support.

RISK OF INCORRECT RESULTS


RISK OF BIOLOGICAL CONTAMINATION
Do not introduce used cuvettes in the rail:
" Use scissors to cut off the damaged part or/and the part with used cuvettes of the
cuvette strip.
" Eliminate biohazardous material according to the local regulations in effect.
" Decontaminate the scissors by placing them into the decontamination solution for 15 mn
(see chap. 4.8.1)

" Place the cuvette roll and its support on a flat surface.
" Remove the used cuvettes from the rail and discard them according to the local
regulation in effect.

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" Slip a Q-tip moistened with some STA Cleaner Solution through the rail window and
gently rub the rail glass (see fig. 6).

Avoid touching electronic cards.

Fig. 6 - Location of the rail glass

" Replace the shield (see chap. 4.2.2).


" Replace the rail cover.
" Turn the STA Satellite back on.

When the following message is displayed:

" Press the Esc key to quit the error message.


The following window is displayed:

" Press the Enter key (cursor on Continue).


" If necessary, load products (see procedure chap. 6.3).

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Maintenance

When the following window is displayed:

" Press the F10 key.


" Replace the cuvette roll with its support and proceed to its loading according to the
procedure described chap. 3.4 by simulating the change of the cuvette bin.

4.2.7 Cleaning the rail, sample and product covers and the needle passage
Weekly maintenance

" Make the sample cover’s needle protection slide toward the back side of the analyzer to
separate it from the sample cover.
" Remove the sample cover’s needle protection.
" Make the product cover’s needle protection slide toward the back side of the analyzer to
separate it from the product cover.
" Remove the product cover’s needle protection.
" Make the needle protection near the well slide toward the product carousel to remove it.

Fig. 7 - Directions to remove the protections

Legend:
1 Sample carousel

2 Product carousel

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" Take a cloth moistened with some decontamination solution (see procedure in chap.
4.8.1).
" Clean the three needle protections.
" Clean the inside and the outside of each cover (rail, sample and product covers).
" Take a Q-tip moistened with a decontamination solution (see procedure in chap. 4.8.1)
to clean the protection groove of the needle end (needle passage).

" Place the sample cover’s needle protection into the notches. The lowest part of the
needle protection must point towards the back side of the analyzer (see fig. 8 ).

Fig. 8 - Placing the sample cover’s needle protection

Legend:
1 Lowest part of the needle protection (it must point towards the back side of the analyzer)

2 Highest part of the needle protection

" Make the sample cover’s needle protection slide towards the front side of the analyzer
to attach it to the cover.
" Place the product cover’s needle protection the same way.
" Place the last needle protection into the notches in front of the well.
" Make the last needle protection slide towards the sample carousel to attach it.

4.2.8 Cleaning the optical sensor


Weekly maintenance
Purpose: Ensure a good operating order of the arm.

RISK OF BIOLOGICAL CONTAMINATION


Observe the precautions of use regarding the handling of biohazardous products according
to the local regulations in effect: use disposable gloves.

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Maintenance

" Turn the STA Satellite off.


" Clean the inside of the optical sensor with a Q-tip or an absorbent slightly moistened with
STA -Cleaner solution (see fig. 9).

Fig. 9 - Location of the optical sensor (front and side views)

" Turn the STA Satellite back on.

In case of biohazardous liquid spatter, use a decontamination solution.

4.2.9 Cleaning of the covering


Weekly maintenance
Purpose: Avoid dirtiness.
" Take a cloth slightly moistened with ethanol (ethanol concentration between 20° and
40°).
" Clean the cover of the STA Satellite , including the keyboard.
.

4.2.10 Cleaning the monitor


Weekly maintenance
Purpose: Avoid dirtiness.
" Take a cloth slightly moistened with ethanol (ethanol concentration between 20° and
40°).
" Clean the monitor

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4.3 Monthly preventive maintenance

4.3.1 Cleaning of dust filters


Monthly maintenance
Purpose: Avoid internal overheating
" Turn the STA Satellite off.
" Take the filter tool which is in the auxiliary materials box.

Fig. 10 - Filter tool

" With the help of this tool, remove the front filter.

Fig. 11 - Removing of dust filter

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Maintenance

" Open the filter support.

Fig. 12 - Open filter support

" Remove the dust present on the filter in an appropriate place, using either of a vacuum
cleaner or compressed air.
" Replace the filter as it was initialy placed (in the same way).

The dust filters are not washable.

" Manually place the filer back into the slides. The largest site of the support (inferior
support in which the smaller superior part fits into) must headed to the down (see mark
A of the following figure).

Fig. 13 - Installation of the filter

" Proceed to the same way to clean:


- The filter is at the right side of the analyzer above the cuvette bin.

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Fig. 14 - Location of the filter which is at the right side of the STA Satellite

- The filter is at the left side of the analyzer above the sample carousel.

Fig. 15 - Location of the filter which is underneath the sample carousel

" Turn the STA Satellite on.

4.4 Quarterly preventive maintenance

4.4.1 Change of the dust filters


See chap. 4.7 "Change of components".

4.5 Yearly preventive maintenance

4.5.1 Change of the needle


See chap. 4.7 "Change of components".

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Maintenance

4.6 Curative maintenance

4.6.1 Cleaning the cuvette bin

RISK OF BIOLOGICAL CONTAMINATION


The cuvette bin contains biohazardous material and must be handled according to the local
regulations in effect: use disposable gloves, mask and protective goggles.

RISK OF INJURY
RISK OF BIOLOGICAL CONTAMINATION
Never introduce your hand or part of your hand in this area when the machine is ON.

Purpose: Cleaning the bin in case of plasma spatters.

" Make a decontamination solution (see procedure in chap. 4.8.1).


" Remove the cuvette bin located on the right side of the STA Satellite (see fig.16) by
pulling it carefully to the right.

Fig. 16 - Location of the cuvette bin

" Remove the disposable bin located inside the cuvette bin and eliminate it according to
the local regulations in effect (see procedure in chap. 3.5.1).
" Pour the decontamination solution in the cuvette bin.
" Wait for 15 minutes.
" Empty the cuvette bin, rinse it with water and dry it.

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" Place a new disposable bin inside the cuvette bin.


(see procedure in chap. 3.5.2)
" Put the cuvette bin back in its location with the new disposable bin. Make sure it is
pushed in all the way.

4.6.2 Cleaning the rail and dismantling the cuvette guiding


Purpose:To ensure a normal running order of the rail when there are some cuvettes stuck,
broken,
spilled or worn under the cuvette guiding.

RISK OF BIOLOGICAL CONTAMINATION


Observe the precautions of use regarding the handling of biohazardous products according
to the local regulations in effect: use disposable gloves, masks and protective goggles.

RISK OF BIOLOGICAL CONTAMINATION


Handling and eliminating the cuvette contaminated by biohazardous products according to
the local regulations in effect.

" Turn the STA Satellite off.


" Remove the rail cover (see fig. 5).
" Unscrew the six screws of the cuvette guiding (see fig. 17, 2,5 Hex key included in the
accessories box).

Fig. 17 - Location of the cuvette guiding screws

" Remove the cuvette guiding.


" Remove the cuvette roll by driving the belt manually.
" Remove the cuvette roll and its support.

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Maintenance

RISK OF INCORRECT RESULTS


RISK OF BIOLOGICAL CONTAMINATION
Do not introduce used cuvettes in the rail:
" Use scissors to cut off the damaged part or/and the part with used cuvettes of the
cuvette strip.
" Eliminate biohazardous material according to the local regulations in effect.
" Decontaminate the scissors by placing them into the decontamination solution for 15
mn.
(see chap. 4.8.1)

" Place the cuvette roll and its support on a flat surface.
" Remove the used cuvettes from the rail and eliminate them according to the local
regulation in effect.
" Carefully clean the rail with a Q-tip moistened with a decontamination solution (see chap.
4.8.1).

Avoid touching electronic cards (see fig. 5).

" Replace the cuvette guiding.


" Screw the six screws back (see fig. 17).
" Replace the rail cover.
" Turn the STA Satellite back on.

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When the following message is displayed:

" Press the Esc key to quit the error message.


The following window is displayed:

" Press the Enter key (cursor on Continue).


" If necessary, load products (see procedure chap. 6.3).
" When the following window is displayed:

" Press the F10 key.


" Take the cuvette roll with its support and proceed to its loading according to the
procedure described chap. 3.4 by simulating the change of the cuvette bin.

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Maintenance

4.6.3 Procedure after a rewinding of the cuvette roll


Purpose: Eliminate the used cuvettes before reloading the cuvette roll

RISK OF BIOLOGICAL CONTAMINATION


Observe the precautions of use regarding the handling of biohazardous products according
to the local regulations in effect: use disposable gloves, masks and protective goggles.

RISK OF BIOLOGICAL CONTAMINATION


Handle and eliminate the used cuvettes according to the local regulations in effect.

2Rewinding of the cuvette roll during the STA Satellite initialization.


The following message is displayed:

" Remove the cuvette roll and its support.

RISK OF INCORRECT RESULTS


RISK OF BIOLOGICAL CONTAMINATION
Do not introduce used cuvettes in the rail:
" Use scissors to cut off the damaged part or/and the part with used cuvettes of the
cuvette strip.
" Eliminate biohazardous material according to the local regulations in effect.
" Decontaminate the scissors by placing them into the decontamination solution for 15
mn.
(see chap. 4.8.1)

" Place the cuvette roll and its support on a flat surface and then, follow the procedure
below:
" Press the Esc key (Continue) to quit the error message.

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The following message is displayed:

" Press the Enter key (cursor on "Continue").


" Load the products if necessary (see procedure chap. 6.3).
" When the following message is displayed:

" Press the F10 key.


" Take the support with the cuvette roll in it and load it following the procedure described
chap. 3.4 by simulating the cuvette bin change.
" Put the scissors in a decontamination solution (see chap. 4.8.1) for 15 mn minimum.

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Maintenance

4.6.4 Manual moving of the cuvette strip (STA Satellite turned off)
Purpose:To restore the correct cuvettes driving in the rail and eliminate the used cuvettes.

Handling the cuvette strip is forbidden when the analyzer is turned off except in case of
recommended maintenance procedure.

RISK OF BIOLOGICAL CONTAMINATION


Observe the precautions of use regarding the handling of biohazardous products according
to the local regulations in effect: use disposable gloves, masks and protective goggles.

" Access the User Maintenance menu.


" Remove the rail cover (see fig. 5 chap. 4.2.5).
" Remove the cuvette strip from the rail pulling the belt manually.
" Remove the cuvette roll and its support.
" Use the scissors to cut the part of the band with the used cuvettes.

RISK OF BIOLOGICAL CONTAMINATION


Handle and eliminate the used cuvettes contaminated by biohazardous products according
to the local regulations in effect.

" Put cuvette roll with its support on a flat surface.


" Replace the rail cover.
" Quit the User Maintenance menu.
The following message is displayed:

" Press the Esc key (Continue) in order to quit the error message.
The following message is displayed:

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" Press the Enter key (cursor on "Continue").


" Load the products if necessary (see procedure chap. 6.3).
When the following message is displayed:

" Press the F10 key.


" Take the roll with its support and load it following the procedure discribed chap. 3.4 by
simulating the cuvette bin change.
" Put the scissors in a decontamination solution (see chap. 4.8.1) for 15 minutes minimum.

4.6.5 Cleaning the product glass


Purpose:To restore a good reading of the product labels by the barcode reader.

RISK OF BIOLOGICAL CONTAMINATION


Observe the precautions of use regarding the handling of biohazardous products according
to the local regulations in effect: use disposable gloves.

" Turn the STA Satellite off.


" Lift the product cover.
" Remove the product carousel.
" Place the product carousel on a flat surface.
" Take a lint-free cloth.
" Slightly moisten the cloth with ethanol (concentration: from 20° to 40°).
" Clean carefully the product glass (see location fig. 18 ).
" Replace the product carousel.
" Turn the STA Satellite on.

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Maintenance

Fig. 18 - Location of the product glass

Legend:

1 Product glass

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Maintenance

4.6.6 Decontamination procedure for STA Cleaner Solution and waste


container
inversion
Purpose:To decontaminate the whole fluidic circuit which has received potentially
biohazardous (contaminated) material.

Estimated time: 4 hours

RISK OF BIOLOGICAL CONTAMINATION


Observe the precautions of use regarding the handling of biohazardous products according
to the local regulations in effect: use disposable gloves, masks and protective goggles.

When connecting or disconnecting containers, observe the color codes:


- red tube for the waste container
- transparent tube for the STA Cleaner Solution.

To carry out this procedure, the bottle plate must be positioned as indicated on the
fig. 19.

Fig. 19 - Positioning of the bottle plate

1 Prepare 1,2 liters of decontamination solution (see chap. 4.8.1).

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Maintenance

2 Turn the STA Satellite off.

3 Remove the bottle plate handle.

4 Remove the waste container (STA Cleaner Solution waste container after the
container inversion on the bottle plate - see location on fig. 19 - mark1) according to
the procedure described below:

- Remove the cap identified in red from the waste container.


- Carefully lift the waste container (see fig. 19 - mark1).
- Completely release the waste container.
- Replace the original screw stopper on the waste container.
- Eliminate the waste container according to the local regulations in effect.

5 Place an empty container as a new waste container.

6 Place the cap identified in red on the waste container (empty container).

7 Remove the STA Cleaner Solution (waste container - see location fig. 19 - mark 2)
according to the procedure described below:

- Remove the cap identified in blue from the container.


- Carefully lift the container (see fig. 19 - mark 2).
- Completely release the container.
- Replace the original cap on the container.
- Eliminate this container as a waste container according to the local regulations in effect.

8 Decontaminate the blue cap of the STA®-Cleaner Solution


(cap + pipe set) according to the procedure described below:

- Moisten a paper towels with a decontamination solution.


- Wipe all traces of stains using the paper towels.
- Pour 200 ml of decontamination solution in a container.
- Place the cap + tube set into the container.
- Wait for 15 minutes.
- Remove the cap + tube set from the container.
- Empty the container in a waste container.
- Rinse into the container the cap + tube set with STA Cleaner solution.
- Empty the container into a waste liquid container.
- Pour 200 ml of STA Cleaner solution.
- Plunge 3 times the cap + tube set into the container.
- Wipe the cap.
- Empty the container in a waste container.
- Eliminate the container and the paper towels as potentially contaminated material
according to the local regulations in effect.

9 Do not replace the container, leave the container emplacement empty.

10 Turn the STA Satellite back on.

11 Press the Del key to access the User Maintenance menu


(see chap. 4.9.1).

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12 Carry out the circuit fluidic purge as indicated below:

- Press the Enter key to access the Maintenance menu.


The Maintenance menu is displayed.
- Press the Enter key until you reach the Rinsing and Purge menu.
The Rinsing and Purge menu is displayed.
- Press the key until you reach the Circuit fluidic purge.
- Press Enter to confirm.
The circuit fluidic purge is carried out.

13 Run purges until the fluidic circuit is empty (display of an error message indicating that
the solution is missing).

14 Turn the STA Satellite off.

15 Take an empty container of STA -Cleaner Solution.

16 Pour 1 liter of decontamination solution into this container.

17 Place the container filled with the decontamination solution at the STA Cleaner
Solution location in the bottle plate (see fig. 19 - mark 2).

18 Place the cap identified in blue on the container.

19 Turn the STA Satellite back on.

20 Press the Del key to access User Maintenance menu


(see chap. 4.9.1).

21 Carry out the circuit fluidic purge as indicated step 12.

22 Repeat the action described above (circuit fluidic purge - step 12) until half of the
decontamination solution is used.

23 Wait for 15 minutes.

24 Carry out purges (step 12) until the container is empty.

25 Turn the STA Satellite off.

26 Remove the waste container as indicated step 4.

27 Place an empty container as a new waste container.

28 Place the cap identified in red on the waste container.

At this step, leave the empty container having received the decontamination solution in the
bottle plate.

29 Turn the STA Satellite back on.

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Maintenance

30 Press the Del key to access User Maintenance menu (see chap. 4.9.1).

31 Carry out a circuit fluidic purge as indicated steps 12 and 13.

32 Turn the STA Satellite off.

33 Remove the cap identified in blue from the STA Cleaner Solution container.

34 Remove carefully the STA Cleaner Solution container (see fig. 19 - mark 2).

35 Take a new STA Cleaner Solution container.

36 Remove the screw stopper from this container.

37 Place the STA Cleaner Solution container in the bottle plate.

38 Place the cap identified in blue on the STA Cleaner Solution container.

39 Turn the STA Satellite back on.

40 Press the Del key to access User Maintenance.

41 Carry out the circuit fluidic purge as indicated step 12.

42 Carry out the circuit fluidic purge as many time as necessary to empty half of the
STA Cleaner Solution container.

43 Quit the User Maintenance menu (see chap. 4.9.2.4).

44 Run quality controls (see chap. 9.4).

45 In case of out of range quality controls, carry out circuit fluidic purges as many time as
necessary to empty an another quarter of the STA Cleaner Solution container (see
circuit fluidic purge - step 12).

46 Run quality controls again (see chap. 9.4).

47 Call your local authorized Service Representative if the quality controls are still out of
range.

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4.7 Component replacement

4.7.1 Replacement of the dust filter


Ref. dust filters (x3) : 80132
" Turn the STA Satellite off.
" With the help of the filter tool, remove the 3 filters (see chap. 4.3.1)
" Open the filter support
" Remove used filters and throw them away (see Fig. 20)
" Place a new filter in each support (see Fig. 20)
" Close the support
" Replace the analyzer filters (see chap. 4.3.1)
" Turn the STA Satellite back on.

Fig. 20 - Replacement of filters

Legend:

1 Upper part

2 Filter

3 Lower part

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Maintenance

4.7.2 Replacement of the needle


Ref. No.: 39356 for needle kit

Fig. 21 - Needle kit

Legend:

1 Protective film of the heating tube

2 Tube

3 Needle

4 Stylet: facultative presence according to the manufacturing date

RISK OF BIOLOGICAL CONTAMINATION


Observe the precautions of use regarding the handling of biohazardous products according
to the local regulations in effect: use disposable gloves.

2Test panel is displayed

ACTIONS RESULTS

Access the User Maintenance menu:  The Main menu is displayed:


" Press the Esc key

with the cursor on Status

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Maintenance

ACTIONS RESULTS

" Press the brightening key:  The User Maintenance menu is


Maintenance displayed:
" or press the key until you reach
Maintenance, then press the Enter key

with the cursor on Maintenance

" Press the Enter key to access the  The following menu is displayed:
Maintenance menu

with the cursor on Rinsing and purge

" Press the key until Needle  The following message is displayed:
replacement. Then press the Enter key
to confirm

" Press the Y key to change the needle  The needle moves above the well and
the following window is displayed:

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Maintenance

ACTIONS RESULTS

" Proceed the replacement of the needle


following the procedure below

ˆ Removing the needle kit

ˆ Before removing the needle, eliminate the electrostatic charging by touching a metal
part of the STA Satellite (e.g. pole, frame,...)

" Turn the STA Satellite off.


" Remove the rail cover (see Fig. 5 - Chap. 4.2.5).
" Remove the cuvette roll by driving the belt manually.
" Remove the cuvette roll and its support.
" Use scissors to cut off the part with used cuvettes of the cuvette strip.

RISK OF BIOLOGICAL CONTAMINATION


Handle and eliminate the used cuvettes contaminated by biohazardous products according
to the local regulations in effect.

" Replace the cuvette roll with its support.


" Replace the rail cover.
" Decontaminate the scissors by placing them into the decontamination solution for 15 mn
(see chap. 4.8.1).
" Place some absorbent paper under the needle.
" Remove the head protection by sliding it to the top (see fig. 22).

Fig. 22 - Head protection

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" Pull out the connector (see mark 2 - fig. 23).


" Unscrew the tubing connection of a quarter turn (or a half turn maximum - see fig. 23).
" Unplug the tube from the tubing connection (the part to be unplugged is showed as
mark 1 - fig. 23).

Make sure not to spill any liquid on the electronic card

" Unscrew the 2 fixation wheels (see mark 3 - fig. 23) using the tightening key or a flat
screwdriver (see fig. 24).
" Remove the needle kit.

Fig. 23 - Location of the needle kit

Legend:

1 Tubing connection - Part to be unplugged

2 J2 connector

3 Fixation wheels

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Maintenance

Fig. 24 - Tightening key for the fixation wheels

Legend:

1 Tightening key (for information, not supplied in the box)

2 Fixation wheel (for information)

RISK OF BIOLOGICAL CONTAMINATION


Discard the needle kit according to the local regulations in effect.

ˆ Reinstalling the needle kit


" Remove the protective film from the heating tube (see fig. 21).
" If there is a stylet (metallic stick located inside the needle), remove it and discard it.
" Position the needle kit until it touches the lower part.
" Slightly screw the 2 fixation wheels.
" Roll up the tube properly.

Make sure you do not pinch the tube (see fig. 23).

" Replace the plug on the tubing connection.


" Screw the tubing connection back of a quarter to half turn (see mark 1 - fig.23).
" Connect the connector back according to the direction shown by the indicators (see
mark 2 - fig.23).

Do not twist the wires.

" Rotate the arm and make sure the needle goes through the prongs of the optical
measurement area (see fig. 9).

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" Screw the fixation wheels a little more without forcing.


" Manually move needle above the well (see fig. 25).
" Adjust the position of the needle the following way:
- Slightly unscrew the fixation wheels.
- Adjust the position of the needle so that it’s exactly at the center of the well (see fig. 25).
- Screw the fixation wheels without forcing.
- Manually pull down the needle into the well.
- Make sure that the needle never touches the edge of the well while going down.
" If necessary, repeat the procedure until you obtain the proper adjustment.

Fig. 25 - Placing the needle above the well

" After setting, hold it tight and give a quarter to a half turn with the tightening key for the
kit or a flat screwdriver to be correctly maintained.
" Manually pull the needle back up above the well then follow the procedure given in the
table below:

ACTIONS RESULTS

" Turn the STA Satellite back on  The following windows are displayed:

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ACTIONS RESULTS

" Proceed requested checks  Needle Purge, then, after several


windows, the following window is
" Replace the head protection by sliding
displayed:
it along its rail
" Press F10 to continue

" Press F10 to continue  After several windows, the following


window is displayed:

" Remove the rail cover (see fig. 5)  The following window is displayed:
" Then press F10 to confirm

" Press F10 to validate  The following message is displayed:

" Rotate the flange in order to unblock the shield.


" Remove the shield (see chap. 4.2.9).
" Take the mapping tool from the auxiliary material box.

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Fig. 26 - mapping tool

Legend:

1 Gauge’s part to be placed to the left of the mapping area.

ACTIONS RESULTS

" Place the mapping tool in incubation  The following message is displayed:
position with the gauge’s black part to
the left of the mapping area (see mark 1
- fig.26)
" Press F10 to continue

" Pull down the needle into the mapping


hole manually or using the following

arrows and
(see marks 1 and 2 , fig. 27)
If necessary, move the mapping tool the
way it is indicated by arrows on fig.27, so
that the needle inserts into the mapping
tool hole

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Fig. 27 - Adjustment: Position of the needle

Legend:

1 Mapping hole

2 Needle

3 Place of the needle in the mapping hole

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ACTIONS RESULTS

" Press F10 to confirm  The following message is displayed:

" Remove the mapping tool  The following window is displayed:


" Replace the shield (see chap. 4.2.2)
" Rotate the flange back in order to fix the
shield
" Replace the rail cover
" Press F10 to confirm

" Press F10 to confirm the setting  The mapping setting is saved and the
following window is displayed:

" Press F10 to return to the previous  The User Maintenance menu is
menu displayed:

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ACTIONS RESULTS

" Press Enter to access the  The following menu is displayed:


Maintenance menu

" Press the key until you reach Last  The date of the recent maintenance is
maintenance dates, then press the displayed
Enter key to validate
" Note the date of the needle
replacement and keep this information

" Press the Esc key  The User Maintenance menu is


displayed:

Return to the Main Menu See chap. 3.2


" Press the key until you reach Return
to previous menu, then press the
Enter key to confirm

" Run a quality control on PT, APTT and  If quality control results are consistent
FIB tests with previous results the STA Satellite
may be used
" Compare the results obtained with the
previous results  Otherwise, repeat the procedure
If the problem remains, contact your
local authorized Service Representative

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It is mandatory to:
ˆ go through the Needle replacement menu to replace the needle.
ˆ run quality controls (PT, APTT and FIB) to validate the needle replacement procedure.

4.7.3 Fuse replacement


Cat. No.: 26681 (6,3 A fuse)

Fuse location Cat. No. Amperage


(see fig. 28)
F1 26681 6,3 A
F2 26681 6,3 A
F3 26681 6,3 A
F4 26681 6,3 A
F5 26681 6,3 A
Main fuses 26681 6,3 A

RISK OF ELECTROCUTION
The analyzer must be turned off during this operation.

Fig. 28 - Fuse replacement

Legend:
1 F1 fuse

2 F2 fuse

3 F3 fuse

4 F4 fuse

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5 F5 fuse

6 Main fuses

Fuses are located on the right panel of the STA Satellite , under the printer (see Fig. 28).

ˆ F1 to F5 fuses:
" Turn the STA Satellite off.
" Insert a screwdriver into the fuse holder slot, unscrew the fuse holder to the maximum
(in the arrow direction, from right to left; see fig. 28); the fuse holder comes off.
" Remove and replace each fuse with a same amperage fuse.
(Cat. No. 26681, 6,3 A amperage)
" Replace the fuse holder of each fuse and screw it back in to the maximum (opposite
direction of the arrow, from left to right; see fig. 28).
" Turn the STA Satellite on.

ˆ Main fuses:
" Turn off the STA Satellite .
" With a screwdriver, unscrew the fuse holder from its seating.
" Remove each fuse and replace it with a same amperage fuse.
(Cat. No.. 26681, 6,3 A amperage)
" Replace the fuse holder in its seating.
" Turn the STA Satellite on.

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4.7.4 Replacement of integrated printer thermal paper


" If necessary, tear off any remaining paper from the printer.
" Open the printer cover.
" Turn the wheel located on the right to free the paper left in the printer.

Do not pull the paper, you may damage the printer.

" Take a thermal paper refill and cut the paper in order to obtain a straight edge, as shown
on the drawing below:

" Insert the paper.


" Turn the wheel located on the right to drive the paper into the printer.

Do not pull the paper, you may damage the printer.

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4.8 Decontamination process

In compliance with recommendations of the S.F.R.L (Syndicat des Fabricants de Réactifs


de Laboratoire) regarding the staff handling biohazardous products, decontamination of the
STA Satellite must be proceeded according to the procedure described below before the
intervention of a representative (especially of a field service engineer) or of a carrier
appointed either by Diagnostica Stago or by one of its official representatives.

The decontamination procedure consists in:


- Cleaning the needle and the washing well
(see chap. 4.2.1)
- Cleaning of the sample and product carousels
(see chap. 4.2.3)
- Cleaning of the measurement rail
(see chap. 4.2.5)
- Cleaning of the rail, sample and product covers and of the needle passage
(see chap. 4.2.7)
- Cleaning of the waste bin
(see chap. 4.6.1)
If the STA Satellite must be switched off for more than one week, follow the procedure
described in chap. 1.6 . 0.37

4.8.1 Preparation of the decontamination solution


Prepare a decontamination solution at 0.37% (approximately) of active chlorine.

To obtain a decontamination solution at 0.37% (approximately) of active chlorine


from a bleach solution and distilled water at ambient temperature:
add N parts of water to 1 part of bleach according to the following formula:

B
N = ----------------- – 1 where B = % of active chlorine in the bleach you use
( 0 · 37 )

For example:
- Bleach at 2.6% of active chlorine:
Mix 1 part of 2.6% active chlorine solution with 6 parts of water
- Bleach at 5.25% of active chlorine:
Mix 1 part of 5.25% active chlorine solution with 14 parts of water
- Bleach at 9.6% of active chlorine:
Mix 1 part of 9.6% active chlorine solution with 25 parts of water.
or
Mix 1 part of bleach at 9.6% of active chlorine with 3 parts of water to obtain bleach at 2.6%
of active chlorine. Then mix 1 part of bleach at 2.6% of active chlorine with 6 parts of water.

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4.9 Maintenance Utilities


This maintenance utility will help the operator to carry out a regular maintenance on the
analyzer. Every time a component is replaced, a test is automatically carried out. If a
problem occurs, this program will also be able to analyze the breakdown or the defect.
The maintenance organization chart is shown below:

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4.9.1 Access the User Maintenance Menu


There are two ways to access this menu.

2Test panel is displayed:

ACTIONS RESULTS

" Press the Esc key  The Main menu is displayed:

with the cursor on Status

" Press the brightening key: Maintenance  The following window is displayed:
" Or press the key until you reach
Maintenance, then press the Enter key
to confirm

 The User Maintenance menu is


displayed:

with the cursor on Maintenance

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2During the starting procedure:

ACTIONS RESULTS

" Starting procedure  The following message is displayed:

" Press the DEL key to access the User  The User Maintenance menu is
Maintenance menu displayed:

with the cursor on Maintenance

4.9.2 Maintenance

4.9.2.1 Needle replacement


See procedure in chap. 4.7.2.

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4.9.2.2 Rinsing and Purge


2The Maintenance menu is displayed
ACTIONS RESULTS

" Press the Enter key to access the  The following menu is displayed:
Maintenance menu

with the cursor on Rinsing and purge

" Press the Enter key to access the  The following menu is displayed:
Rinsing and Purge menu

with the cursor on Rinse the needle

" Press the Enter key to Rinse the  The needle goes down into the well
needle
 Needle rinsing is run

" Press the key until you reach Purge  Fluidic circuit purge is run
the fluidic circuit, then press the
Enter key to confirm

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4.9.2.3 Dates of recent maintenance


2Maintenance menu is displayed
ACTIONS RESULTS

" Press the Enter key to confirm  The following menu is displayed:

with the cursor on Rinsing and purge

" Press the key until you reach Last  The date and time of recent
maintenance dates, then press the maintenance are displayed for:
Enter key to confirm - the needle replacement
- the purge
- the decontamination

Record the date for each needle replacement and keep this information.

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4.9.2.4 Quit the Maintenance Menu

2Maintenance menu is displayed

ACTIONS RESULTS

" Press the until you reach Return to  The User Maintenance menu is
previous menu, then press the Enter displayed
key

4.9.3 Internal printer


This software checks that:
- the printer is correctly connected
- the printer prints out texts and diagrams correctly
For the integrated printer maintenance (thermal paper replacement), see chap. 4.7.4.

4.9.3.1 Access the internal printer menu

2User Maintenance menu is displayed:


ACTIONS RESULTS

" Press the key until you reach Printer,  The Printer menu is displayed:
then press the Enter key to confirm

with the cursor on Test of the internal


printer

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4.9.3.2 Connection check


2Printer menu is displayed with the cursor on Test of the Internal printer testing

ACTIONS RESULTS

" Press the Enter key  The following menu is displayed:

with the cursor on Connection


checking

" Press the Enter key  The following message is displayed on


the screen:

 The following message is printed on the


paper: " Test of the internal printer"
 Return to Test of the Internal printer
menu

ˆ If the following message " Test of the


internal printer" is not printed:
" Turn the STA Satellite off and connect
the printer again
" Turn the STA Satellite back on and
rerun the internal printer test

If printing problems remain, call your local authorized Service Representative.

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4.9.3.3 Character set testing


2Test of the Internal printer menu is displayed.

ACTIONS RESULTS

" Press the key until you reach Test of  The TEST OF THE CHARACTERS screen is
the characters, then press the Enter displayed (see Fig.31)
key to confirm

Fig. 29 - PRINTER CHARACTER SET TEST window

The Ctrl key of the above screen is represented by the Symb key of the STA Satellite
keyboard.

ACTIONS RESULTS

" Press simultaneously the Symb key  The date, the time, the STA Satellite
and the I key to print the screen display number, the software version and the
character set are printed

" Check the printout  Two possibilities:


- The printing is correct
- If problems occur, the operator should
check the printer (paper, cleanliness...)

" Press the Esc key to return to the  The Printer menu is displayed
Printer menu

If the problems remain, call your local authorized Service Representative.

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4.9.3.4 Graph
2Test of the Internal printer menu is displayed.

ACTIONS RESULTS

" Press the key until you reach The GRAPHICS screen is displayed (see Fig.
Graphics, then press the Enter key to 30)
confirm

Fig. 30 - GRAPHICS Screen

ACTIONS RESULTS

" Press simultaneously the Symb key  The whole screen display is printed
and the I key to print the screen display

" Check the printout  Two possibilities:


- The printing is correct
- If problems occur, the operator should
check the printer (paper, cleanliness...)
and do the test again

" Press the Esc key to return to the  The Printer menu is displayed
previous menu

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If problems remain, call your local authorized Service Representative.

4.9.4 External printer


This software checks that:
- the printer is correctly connected
- the printer prints out texts and graphs correctly
For external printer maintenance (toner cartridge or ink ribbon replacement) see the printer
user manual.

4.9.4.1 Connection checking


2Printer menu is displayed with the cursor on Test of the Test of the external printer
test.

ACTIONS RESULTS

" Press the key until you reach Test of  The following menu is displayed:
the external printer, then press the
Enter key to confirm

with the cursor on Connection


checking

" Press the Enter key to access the  The following message is displayed:
menu "printer connected"
 Return to Test of the external printer
menu

" Connect the printer again if the


following message "printer connected"
is not displayed and try again

If printing problems remain, call your local authorized Service Representative.

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4.9.4.2 Character set testing


2External printer menu is displayed.

ACTIONS RESULTS

" Press the key until you reach Test of  The TEST OF THE CHARACTERS screen is
the characters, then press the Enter displayed (see Fig.31)
key to confirm

Fig. 31 - PRINTER CHARACTER SET TEST display

The Ctrl key of the above screen is represented by the Symb key of the STA Satellite
keyboard.

ACTIONS RESULTS

" Press simultaneously the Symb key  The whole screen display is printed
and the I key to print the screen display

" Check the printout  Two possibilities:


- The printing is correct.
- If problems occur, the operator should:
• Check the printer setup (switches) (see
chap. 4.9.4.5).
• Check the printer (paper, ribbon,
cleanliness...)

" Press the Esc key to return to the  The Printer menu is displayed.
Printer menu

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4.9.4.3 Graph
2External printer menu is displayed.

ACTIONS RESULTS

" Press the key until you reach  The GRAPHICS screen is displayed
Graphics, then press the Enter key to (see Fig .32)
confirm

Fig. 32 - GRAPHICS Screen

ACTIONS RESULTS

" Press simultaneously the Symb key  The whole screen display is printed
and the I key to print the screen display

" Check the printout  Two possibilities:


- The printer is connected
- If problems occur, the operator should:
• Check the printer setup (switches) (see
chapter 4.9.4.5).
• Check the printer (paper, ribbon,
cleanliness...)

" Press the Esc key to return to the  The Printer menu is displayed on the
previous menu monitor

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4.9.4.4 Quit the PRINTER menu


2Printer menu is displayed.

ACTIONS RESULTS

" Press the key until you reach Return  The User maintenance menu is
to previous menu, then press the displayed on the monitor
Enter key to confirm

4.9.4.5 External printer setup


The printer must be configured in IBM or EPSON mode, see printer manual and observe the
following recommendations:

PARAMETRE SELECTION OBSERVATION

Emulation mode IBM Proprinter X24E Primordial, any other


selection will lead to
unpredictable results in
graphic mode.

Character set Code page 437 Primordial for all semi-


graphic characters (table
printout).

Interface type Parallel STA Satellite cannot


control printing through
serial mode.

Image Density High density (≥ 300 dpi) If applicable

Auto line feed No No automatic line feed after


a carriage return.

Page length 11 or 12 inches Depending on the type of


paper used.

Line spacing 6 lines per inch If applicable.

Print Quality Draft mode If applicable, to speed up


the printing

Skip-Over perforation No If applicable.

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4.9.5 Saving
This program allows to save or to load the following parameters:

Diagnostica Stago cannot be held responsible in case of data-processing contamination or/


and malfunction of user’s equipment resulting from the use of floppy disks or any other
material in particular during the saving and/or file transfers as described in this manual.

Before saving, format the floppy disk with the STA Satellite (see chap. 4.9.5.5).
To avoid computer virus, do not use the saving floppy disk on an other PC system.

- The rereading (loading of saved data causing the overwriting of data already present in
the data base) of parameters must be done with the approval of your local authorized
Service Representative.

- Empty the Product carousel before loading parameters.

SAVING LOADING

Test setup After each modification of the With the approval of


test setup or of the global your local authorized
options. Service
Representative.

System Parameters After each modification of the With the approval of


system parameters or after your local authorized
each intervention of your local Service
authorized Service Representative.
Representative.

Error Messages Only for your local authorized Only for your local
Service Representative. authorized Service
Representative.

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4.9.5.1 How to access Saving menu

2User maintenance menu is displayed.

ACTIONS RESULTS

" Press the key until you reach Saving,  The SAVE/REREAD THE PARAMETERS
then press the Enter key to confirm screen is displayed (see Fig. 33 )
 The cursor is on Selection of Items

Fig. 33 - Save/reread the parameters display

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4.9.5.2 Item selection


2SAVE/REREAD THE PARAMETERS screen is displayed.

ACTIONS RESULTS

" Press the Enter key to Select the  The cursor moves to the Test Settings
items window
 A help window for selection is displayed
on the left lower-hand corner of the
screen:

 The following items can be selected:


- Test Settings
- System Parameters
- Error Messages

Select items ; for that:  Item selection is done


" Press the and keys to move the
cursor
" Press the Space bar to select or
unselect an item
" Press the F8 key to select or unselect
all items
" Press the Esc to cancel selection

" Press the F10 to confirm selection  Item selection is confirmed

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4.9.5.3 Rereading
Prior: select items to be loaded (see chap. 4.9.5.2).

This operation erases all data contained in the selected files (Test Settings, System
parameters and/or error messages).

Do not load error messages.


Check that this item has not been selected by mistake: this option is only for your local
authorized Service Representative .

2SAVE/REREAD THE PARAMETERS screen is displayed.

ACTIONS RESULTS

" Press the Enter key to select the  The following window is displayed:
parameters

" Press the key to Rereading, then  The following window is displayed:
press the Enter key to confirm

" Identify yourself (see chap. 4.9.13.5)  The following windows are displayed,
depending on the items selected:
SAVING/LOADING PARAMETERS
Do you want to re-read
selected parameters ?

Return: Validate - Esc : Cancel


or
SAVING/LOADING PARAMETERS
Warning: this operation will
erase parameters on the STA Satellite

Return: Validate - Esc : Cancel

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ACTIONS RESULTS

" Press the Enter key to confirm  The following window is displayed:
SAVING/LOADING PARAMETERS
Please insert a floppy disk
for loading.
Do not remove the floppy disk
while loading !

Return: Validate - Esc : Cancel

" Insert the loading floppy disk into the  The following messages are displayed:
floppy drive
Checking floppy disk...
" Press the Enter key to confirm in process
Then
Rereading in progress
Please wait

Advance %
/__/__/__/__/__/
Rereading OK
 The SAVE/REREAD THE PARAMETERS
window is displayed

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4.9.5.4 Saving
Prior: Select the items to be saved (see chap. 4.9.5.2).

2SAVE/REREAD THE PARAMETERS screen is displayed.

ACTIONS RESULTS

" Press the key until you reach Saving,  The following window is displayed:
then press the Enter key to confirm
SAVING/LOADING PARAMETERS
Do you want to save
selected parameters ?

Return: Validate - Esc : Cancel

" Press the Enter key to confirm  The following window is displayed:
SAVING/LOADING PARAMETERS
Please insert floppy disk
for saving.
Do not remove the floppy disk
while saving !

Return: Validate - Esc : Cancel

" Insert a 3" 1/2 floppy disk into the  The following window is displayed:
floppy drive, then press the Enter key
Checking floppy disk...
to confirm
Please wait

 The following window is displayed if all


items have been selected:
SAVING/LOADING PARAMETERS
Press Return to start fomatting

Warning: this operation will


erase all data on the floppy disk

Return: Validate - Esc : Cancel

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ACTIONS RESULTS

" If all items have been selected, press  The following windows are displayed
the Enter key to confirm during formatting (if all items have been
selected):
Formatting in progress
Please wait

Advance %
/__/__/__/__/__/

 The following windows are displayed in


any case:
Saving in progress
Please wait

Advance %
/__/__/__/__/__/
Saving OK

 The SAVE/REREAD THE PARAMETERS


screen is displayed

4.9.5.5 Floppy disk formatting

Formatting will erase all data (all files) on the floppy disk. This operation allows you to use
the floppy disk again with full capacity.

2 SAVE/REREAD THE PARAMETERS screen is displayed.

ACTIONS RESULTS

" Press the key until you reach Format  A warning window is displayed:
a floppy disk, then press the Enter
SAVING/LOADING PARAMETERS
key to confirm
Please insert floppy disk in
order to format.

Warning: this operation will


erase all data on the floppy disk

Return: Validate - Esc : Cancel

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ACTIONS RESULTS

" Insert a 3" 1/2 floppy disk into the floppy  The following windows are displayed
drive, then press the Enter key to during formatting:
confirm Formatting in progress
Please wait

Advance %
/__/__/__/__/__/

 The SAVE/REREAD THE PARAMETERS


screen is displayed at the end of the
formatting

4.9.5.6 Device status

2 SAVE/REREAD THE PARAMETERS screen is displayed.

ACTIONS RESULTS

" Press the key until you reach Device  The system backup window is
status, then press the Enter key to displayed:
confirm

" Press the S key to save data files  The following message is displayed:

" Insert 3" 1/2 floppy disk into the floppy  The following message is displayed:
drive as requested, then press the
Saving in process
Enter key to confirm
 Display of the saved data file names
 Then, the following messages are
displayed:
Testing in process
Saving OK
Press (enter) to continue

" Press the Enter key  The SAVE/REREAD THE PARAMETERS


screen is displayed

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4.9.5.7 Quit the Save/reread the parameters menu

2 SAVE/REREAD THE PARAMETERS screen is displayed.

ACTIONS RESULTS

" Press the key until you reach Return  The following window is displayed:
to previous menu, then press the
Updating files...
Enter key to confirm
Please wait...
 The USER MAINTENANCE menu is
displayed

4.9.6 TDEX utility program (Data processing export of patient’s results)


This program allows the operator to save patient’s results related to:
- results (name of the test, Id, mean,...)
- associated calibrations (measurements, equation,...)
- used products (designation, lot number,...)
These file patient data stored in the Work File (Confirmation/Printout/Transmission
Menu, see chap. 8.1 and 8.2) will be transferred into a floppy disk whether the tube is loaded
into the sample carousel or not.
The created file is a "text" file (.txt) which can be used with other software (e.g. Excel).

2User maintenance menu is displayed.

ACTIONS RESULTS

" Press the key until you reach  The following screen is displayed
Utilities, then press the Enter key to (see Fig. 34)
confirm

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Fig. 34 - TDEX utility program display

ACTIONS RESULTS

" Type the file name (maximum 8  Creation of a “xxxxxxxx.txt” file


characters) then press the Enter key to
confirm
" Type comments if necessary
You can type up to 5 lines of comments,
each line contains 75 characters
" Press the Enter key to confirm
" Insert a formatted floppy disk into the
floppy drive

" Press the F10 key to transfer data  The following window is displayed
TRANSFER IN PROGRESS....

 The data transfer from the hard disk to


the floppy disk is carried out

" Press the Esc key to quit  The following window is displayed:

" Press the Y key  The User maintenance menu is


displayed

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4.9.7 Host Computer communications


This program checks the communications between the host computer and the STA
Satellite . It gives a summary of the communication parameters selected (see description
in chap. 10.2.3.2).
2User maintenance menu is displayed.

ACTIONS RESULTS

" Press the key until you reach Host  The COMMUNICATION window is
computer communications then displayed
press the Enter key to confirm

" Press the F1 key to carry out a test  The following window is displayed:
" Check connection between the STA TEST IN PROGRESS....
Satellite and the host computer if any
problem occurs and carry out the tests
 SUCCESS/FAILURE notice is displayed on
again
the screen

" Press the Esc key to quit  The following window is displayed:

" Press the Y key  The User Maintenance menu is


displayed

4.9.8 Barcode reader


This program checks if the codes read by the reader are the same as the ones expected.
This program can be used after the reader setup (see a customer representative for this
operation) in order to determine, if necessary, the characters to be eliminated during the
code reading (this procedure is carried out using the Global Option menu, see chap.
10.2.2.3).
The character elimination is considered during the sample loading but not in this menu.

To avoid barcode reading errors, only the used code must be activated. If necessary, the
unused codes are inactivated (see Fig. 35).

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Fig. 35 - Barcode reader screen display

Legend:

1 List of possible codes,


ENABLE: Barcode reader configured to read the code,
DISABLE: Barcode reader not configured to read the code

2 Display of the barcode read after scanning of the barcode label in front of the reader

3 Parameters of the code selected in zone 1

4.9.8.1 Information display


2User Maintenance menu is displayed
ACTIONS RESULTS

" Press the key until you reach  The BARCODE READER screen is
Barcode Reader, then press the Enter displayed (see fig. 35)
key to confirm

" Scroll information with the and  Reading of the parameters of each
arrows barcode

" Press the Esc key to quit  The following window is displayed:

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ACTIONS RESULTS

" Press the Y key  The User maintenance menu is


displayed

4.9.8.2 Reading test


2BARCODE READER screen is displayed.

ACTIONS RESULTS

" Take an STA product  Screen display of the product


identification
" Scan the label barcode in front of the
reader

" Take a laboratory label ˆ When the label is detected:


" Scan the label barcode in front of the  Display of the value read
reader (see zone 3 on fig. 35)
ˆ When the label is not detected:
 Code not configured, contact your local
authorized Service Representative

" Press the Esc key to quit  The following window is displayed:

" Press the Y key  The User Maintenance menu is


displayed.

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4.9.9 Error History


This program shows error messages that have been displayed when the STA Satellite was
running.

4.9.9.1 How to access the ERROR LOG menu

2User Maintenance menu is displayed.

ACTIONS RESULTS

" Press the until you reach Error log  The error history window is displayed
with the last error message saved
" Press the Enter key
(see fig. 36)

Fig. 36 - Error History screen display

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4.9.9.2 Parameter selection


2ERROR LOG screen is displayed.

ACTIONS RESULTS

" Press the F2 key  The first selection criteria are displayed
on the screen:

" Press the key to display the other  The last selection criteria are displayed
selection criteria. on the screen:

" Type your selection (2 figures) then  The ERROR HISTORY screen is displayed
press the F10 key to confirm

" Press the key or the key to display  The selected errors are displayed
selected error messages

4.9.10 Data update


This program enables to load new data provided by Diagnostica Stago: new software
releases, introduction of new reagents or new methods, etc.

To avoid computer viruses, use the floppy disks provided by Diagnostica Stago only with
the STA Satellite .

ˆ Software update

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2User Maintenance menu is displayed.

ACTIONS RESULTS

" Press the key until you reach data  The following window is displayed:
update, then confirm with the Enter
key

" Type your ID (see chap. 4.9.13.5)  The following window is displayed:
DATA UPDATE
Insert floppy disk in the drive...
Esc : QuitF10: Validate -

" Insert floppy disk #1 from the floppy disk  Data is tranfered from the hard disk to
set provided by Diagnostica Stago into the floppy disk.
the floppy disk, then confirm with the  The following window is displayed:
F10 key
Insert floppy disk #2 in the drive
Press ↵ to continue
(SPACE: SOUND=OFF)
 A beep sound is emitted (this sound can
be stopped by pressing the Space bar)

" Remove floppy disk #1 from the floppy  Data is transferred from the floppy disk
drive to the hard disk
" Insert floppy disk #2 from the set  The following message is displayed:
provided by Diagnostica Stago then
Insert floppy disk #3 in the drive
confirm with the Enter key
Press ↵ to continue
(SPACE: SOUND=OFF)
 A beep sound is emitted (this sound can
be stopped by pressing the Space bar)

" Insert and remove floppy disks again  When the data on every floppy disk has
as many times as requested been transferred to the hard disk, the
following window is displayed:
Confirmez la modification de données
(Confirm modification)
of data files
[ ] OUI (YES) [Esc] = NON (NO)

" Press the Enter key  The following window is displayed:


Installation terminée
(Installation done)
↵ = Continuez (Continue)

" Press the Enter key  The following message is displayed:


“Press any key to continue”

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ACTIONS RESULTS

" Press any key  If the last floppy disk (for instance the
fourth) has not been removed from the
floppy drive, the following message is
displayed:
“Remove floppy disk #4 from the drive
Press ↵ to continue
(SPACE: SOUND=OFF)
 A beep sound is emitted (this sound can
be stopped by pressing the Space bar)

" Remove the last floppy disk from the  The STA Satellite proceeds files
floppy drive then confirm with the Enter updates and sequence loading if
key necessary.
 Then, the following message is
displayed:
“Enter the last 4 digits of the STA
Satellite serial number”

" Look for the serial number on the  Reboot of the STA Satellite (see chap.
identification label (left side of the 3.2)
analyzer), type the last 4 digits of the
number, then confirm by pressing the
Enter key

4.9.11 Photometry graphics


ˆ In case of result errors regarding colorimetric/immunologic, this program will allow you to
send information to your local authorized Service Representative.
ˆ Enables to create new methods for the STA Satellite .

4.9.11.1 Accessing the photometry graphics menu


2User Maintenance menu is displayed.

ACTIONS RESULTS

" Press the key until you reach  The list of the 99 last files is displayed on
Photometry graphics and press the the screen.
Enter key to confirm
 The following keys are available:

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ACTIONS RESULTS

" Press the to select the file to display  The file selected is displayed
then press Enter (see Fig. 37 )
 The following keys are available:
F2 Delete point
F3 STA Satellite
F4 Position the cursor on the points or
on the curve
F5 Change scale: reduced/normal
F6 Print curve
F7 Print raw data
F8 Modify window
F10 Other patient

Fig. 37 - Photometry graphic screen display

Legend:

1 List of available functions:

F2 In DO/Minute kinetic mode, enables to eliminate (or to put back) a point


for the regression calculation

F3 In DO/Minute kinetic mode, enable to display:

F3 STA Satellite In yellow points used by the STA Satellite for regression calculation,
calculation(The other points are displayed in red)

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F3 Full calculationAll points recorded by the STA Satellite during the test

If no results have been provided by the STA Satellite , no regression curve is displayed ;
in zone 7, regression coefficient will be zero - R =0.000

F4 Selection of the cursor motion on the measurement points or on the regression curve.

F5 Displays graph between the minimum and the maximum measurement (zoom) or
between criteria OD min. and OD max. (normal scale)

F6 Printout of the screen display

F7 Printout of the measurement table


The pairs of points [Time (sec) ; Optical Density (OD)] displayed in bold characters
are the ones used for the regression calculation by the STA Satellite .

F8 To change the limits of the window calculation

F10 To load another measurement file

To move the cursor

+- To Modify the cursor motion value

2 Name of the display: Colorimetry Graphics or Immunology Graphics depending on the


test

3 Date and time of results saving, file name and channel used for measurement

4 Abbreviation of the test, type of method (OD/minute kinetics or kinetic 2 points), and file
identification

5 Measurement points and regression curve

- Points displayed in yellow: points used for the regression calculation


- Points displayed in red: points not used for the regression calculation

6 Rejection criteria:

OD/Minute kinetic:
minimum O.D.=0 Recall of the linearity range of the measurement system
maximum O.D.=2.0measurement system.
Slope = Default value (- 0,100), allows to control that kinetic curves are with
positive and not negative slopes.
R= Regression coefficient for the test selected as defined in the
tests setup screen.

kinetic 2 points:
Minimum OD =0 Recall of the measurement system linearity zone
Maximum OD =2.0

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7 Curve Characteristics:

OD/Minute kinetic:
OD = a + b * Time
OD = Regression line
a = Intercept
b = Slope
R = Regression coefficient

The equation of the regression curve (OD) and the regression coefficient (R) are calculated
using the yellow points that are located within the measurement window. These values are
updated every time a point is added or removed from the window and after use of the F3 key.
kinetic 2 points:
Δ DO = DO (T1) - DO (T0)
T0 = Initial time
T1 = Final time
OD (T1) = Optical density at the instant T1
OD (T0) = Optical density at the instant T0

The variation of optical density (Δ OD) is calculated with OD (T1) and OD (T0) points. The
calculation is updated if the measurement window limits are modified.

8 Display of the OD and of the time according to the cursor position

9 Calculation window

4.9.11.2 Removing points


2Photometry graphics menu displayed.

ACTIONS RESULTS

" Press the → key until you reach the  The point is eliminated from regression
point to be eliminated, then press the calculation
F2 key to confirm
 The new regression curve is displayed

" Repeat the operation if necessary

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4.9.11.3 STA Satellite Calculation


2Photometry Graphics menu is displayed (F3 STA Satellite calculation is displayed).

ACTIONS RESULTS

" Press the F3 key  All points used by the STA Satellite for
the regression calculation (patient
result) are displayed in yellow on the
screen, points that have not been used
are displayed in red
 The regression curve is displayed on the
screen

4.9.11.4 Curve printout


2Photometry Graphics menu is displayed.

ACTIONS RESULTS

" Press the F6 key  PHOTOMETRY GRAPHICS display printout

4.9.11.5 Measurement printout


2Photometry Graphics menu is displayed.

ACTIONS RESULTS

" Press the F7 key  Printout of the measurement carried out


by the STA Satellite during the test
 The pairs of points [Time (sec.) ; Optical
Density (OD)] displayed in bold are the
ones used for the regression calculation
(result given by the STA Satellite )

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4.9.11.6 Window modification


2Photometry graphics menu is displayed.

ACTIONS RESULTS

" Press the F8 key  The following window is displayed:


File Name: COLMESXX.DAT
Initial Time: XX (seconds)
Final Time: XX (seconds)
Esc: Quit - F10: Validate
XX : Values used for colmesxx.dat file

" Change the initial / final time using the  The calculation window and the
numerical pad, then press the Enter regression curve are updated
key
" Press the F10 key to confirm
modifications

4.9.11.7 Other patient


2Photometry Graphics menu is displayed.

ACTIONS RESULTS

" Press the F10 key  The list of the last 99 tests is displayed
on the screen

" Press the key until you reach the file  The selected Photometry Graphics is
to be displayed, then press the Enter displayed on the screen
key to confirm

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4.9.11.8 Quitting the photometry graphics menu


2Photometry Graphics menu is displayed.

ACTIONS RESULTS

" Press the Esc key  The following window is displayed:

" Press the Y key  The User Maintenance is displayed

4.9.12 Language Setting


2User Maintenance menu is displayed.

ACTIONS RESULTS

" Press the key until you reach  The following screen is displayed:
Language Setting
" Press the Enter key to confirm

" Press the key until you reach the  The selected language is validated
desired language
 The STA Satellite reboots
" Press the F1 key to confirm

4.9.13 Users management

4.9.13.1 Description

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This program enables the laboratory managers to create, to manage and to allocate the
access codes to authorized people only.

Before defining access codes, read carefully the chap. 1.5.

The access codes are aimed at restricting the access to some software’s functions to
authorized people only.
The functions that require an access code are classified according to 4 levels. One of those
levels is the administrator one (see next table).
Each user can access both the functions of the level allocated by the administrator and the
functions of lower level(s).
For instance: the allocation of the level 2 enables the access to levels 2 and 1.
The "Administrator" level can only be allocated to one person, usually the laboratory
manager. This level is allocated either by a Diagnostica Stago representative or by one of
its official distributors during the installation of the STA Satellite .

ACCESS CORRESPONDING AUTHORIZED FUNCTIONS


LEVEL MENU
- Quick start of calibrations (F1, F10)
Level 1
Calibration (see chap. 7.3.7)
- Starting calibrations (linear mode, bar
code, raw)
(see chap. 7.3)
- Rerun controls
(see chap. 7.4.4)

- Rerunning tests
Validation/ Publishing/ (see chap. 8.3.2 and 8.3.3)
Transmission - Deleting tests
(see chap. 8.3.2 and 8.3.3)

- Quick start of quality controls


Quality Control (see chap. 9.4.5)
- Starting quality controls
(see chap. 9.3.2)

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Level 2 - Deleting old files


Initialization
(see chap. 3.2.1)

Confirmation/ Printout/ - Accepting tests


Transmission (see chap. 8.3.2 and 8.3.3)
- Validating files
(see chap. 8.3.2 and 8.3.3)
- Customized print
(see chap. 8.8.3 and 8.8.4)
- Selective deletion of files
(see chap. 8.6.3)

Calibration - Validation request, manual rerunning,


cancelling of a calibration
(see chap. 7.4)
- Adjusting the offset
(see chap. 7.5.2)
- Adjusting the measures
(see chap. 7.5.3)
- Changing reference time/range
(see chap. 7.2.3)
- Cancelling a calibration
(see chap. 7.4.9)
- Rerunning a calibration
(see chap. 7.4.8)
- Modification of a 100 % point
(see chap. 7.5.1)

Quality Control - Changing range values for quality


controls
(see chap. 9.4.3)
- Cancelling a quality control run
(see chap. 9.6.1)
- Deleting controls of the day
(see chap. 9.6.2)
- Accepting out of range quality
controls
(see chap. 9.5.2.1),
- Rerunning out of range quality
controls
(see chap. 9.5.2.2)

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Level 3
Calibration - Modification of a 100 % point
(see chap. 7.5.1)

Test Setup - Setup parameter modification


(see chap. 5.3)
- Creation of a new test
(see chap. 5.4)
- Test deletion
(see chap. 5.6)
- Test update
(see chap. 5.7)

Quality Control - Delete all quality control results


(see chap. 9.6.3)

System Status - Modification of the date and/or time


(see chap. 4.9.14)
- Modification of the level detection
management
(see chap. 10.1.2.2)

Global Options - Accessing global option screens


(see chap. 10.2)

User Maintenance - Data update


(see chap. 4.9.10)
- Saving
(see chap. 4.9.5)
- Changing the system date and time
(see chap. 4.9.14)

Administrator Level User Maintenance - Users management


(see this chapter)

- Modification of a 100 % point


Calibration (see chap. 7.5.1)

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4.9.13.2 Accessing the users management menu


2User Maintenance menu is displayed.

ACTIONS RESULTS

" Press the key until reaching Users  The following window is displayed:
Management
" Press the Enter key to confirm

" Identify yourself  The Users Management screen is


displayed (see Fig. 38 )

Fig. 38 - Users Management screen

Legend:

1 List of available functions:

F2 Deleting a user, in this case the following window is display:

F4 Adding a user

2 Screen name

3 Users list / Selection of a user

4 Number of users - Number of pages

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5 Administrator name

6 Login field (from 3 to 12 characters)


Password field (6 characters or from 2 to 6 characters if no login)

7 Determination of the group (access level)

4.9.13.3 Creating a user


A user is defined by a login, a password and an access level.
It is possible to create a user with no login.

2Users Management screen is displayed.

ACTIONS RESULTS

" Press the F4 key  The cursor moves on the Login field

" Type the login (or nothing for a no login  The cursor moves on the empty
user) of the user to be added password field
" Press the key to access to the next
field

" Type the password of the user to be  The new login (for example: USER4) (or
added @ No login @ for a no login user) is
added in the users list (see fig. 38 - mark
" Press the key until reaching the
3)
access level of the user to be added
 The following message is displayed:
" Press the Del key to select this level
" Press the Enter key to confirm
Or, for a no login user:

" Press the Esc key  The User Maintenance menu is


displayed

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4.9.13.4 Deleting a user


2Users Management menu is displayed.

ACTIONS RESULTS

" Press the key until reaching the login  The following window is displayed:
of the user to be deletted (eg: USER4)
" Press the F2 key

" Press the Y key  The login is deleted in the users list (see
fig. 38 - mark 3)
 The following message is displayed:

4.9.13.5 Accessing a STA Satellite protected function


2Accessing a protected function (see the list of functions chap. 4.9.13.1).

ACTIONS RESULTS

" Access a protected function  The following window is displayed:

" Type in your login  The requested function is displayed if


your access level allows it
" Press the key
" Type in your password
OR
" Type in the password for a no login
connection
" Press the Enter key to confirm

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4.9.14 Changing the system date and time


2Current system date and time are displayed on the upper right corner of the USER
MAINTENANCE screen.

4.9.14.1 Changing the date


2USER MAINTENANCE screen is displayed.

ACTIONS RESULTS

" Press the key until reaching System  The following window is displayed:
date and time
" Confirm using the Enter key

with the cursor on Back to previous


menu

" Press the key until reaching Change  The following window is displayed:
current system date
" Confirm using the Enter key

" Identify yourself (see chap. 4.9.13.5)  The ENTER NEW DATE window is
displayed:

The separator (.) and the display format are


defined in page 2 of the GLOBAL OPTIONS
screens (see description in chap. 10.2.3.4)

" Type in the new date respecting the  The date is updated
format and separator displayed  The following menu is displayed:
In this example, type in:
the day (2 digits), the . key,
the month (2 digits), the . key,
the year (4 digits).
" Confirm using the Enter key with cursor on Back to previous menu

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4.9.14.2 Changing the time


2USER MAINTENANCE screen is displayed.

RESULTS

" Press the key until reaching System  The following menu is displayed:
date and time
" Confirm using the Enter key

with the cursor on Back to previous


menu

" Press the key until reaching Change  The following window is displayed:
current system time
" Confirm using the Enter key

" Identify yourself (see chap. 4.9.13.5).  The ENTER NEW TIME window is
displayed :

The separator (.) and the display format are


defined in page 2 of the GLOBAL OPTIONS
screens (see description in chap. 10.2.3.4).

" Type the new time respecting the format  The time is updated.
and the separator displayed.  The following window is displayed:
In this example, type:
the time (2 digits), the . key,
the minutes (2 digits), the . key,
and the seconds (2 digits).
" Confirm using the Enter key with the cursor on Back to previous
menu.

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4.9.15 Return to the main menu


2User Maintenance menu is displayed.

ACTIONS RESULTS

" Press the key until you reach Return  See chap. 3.2.
to the previous menu.
" Press the Enter key to confirm.

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5 Test setup ................................................ 1

5.1 Description of Test Setup Parameters . . . . . . . . . . . . . . . . . . . . . . . . . 1


5.1.1 Methodology (page 1 of 3) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
5.1.1.1 Test identification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
5.1.1.2 Sample definition . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
5.1.1.3 Diluent definition . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
5.1.1.4 Reagent definitions (Ra, Rb, Rc, Rd) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
5.1.1.5 Wash definition . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
5.1.1.6 Analysis parameter definition . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
5.1.1.7 Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
5.1.1.8 Validation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
5.1.1.9 Redilution conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
5.1.2 Calibration (page 2 of 3) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
5.1.2.1 Calibration mode definition . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
5.1.2.2 View points . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
5.1.2.3 Calibrator definition . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
5.1.2.4 Scale definition . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
5.1.2.5 Type of determination for the calibrators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
5.1.2.6 Offset correction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
5.1.2.7 Calibration control definition . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
5.1.3 Result and quality control printout / transmission (page 3 of 3) . . . . . . . . . . 23
5.1.3.1 Printout / transmission . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
5.1.3.2 Usual value definition . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
5.1.3.3 Printout limit definition . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
5.1.3.4 Quality control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
5.1.4 Dependent tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26

5.2 Accessing the Test Setup parameters . . . . . . . . . . . . . . . . . . . . . . . . 28


5.2.1 Accessing the TEST SETUP menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
5.2.2 Description of the TEST SETUP screen display . . . . . . . . . . . . . . . . . . . . . 29
5.2.3 Accessing setup screens for main tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
5.2.4 Accessing the dependent tests setup screen . . . . . . . . . . . . . . . . . . . . . . . . 31
5.2.4.1 Accessing the dependent tests setup screen
from the TEST SETUP screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31

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5.2.4.2 Accessing the dependent tests setup screen


from the setup of the main test wanted . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
5.2.5 Accessing the setup parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32

5.3 Setup parameter modification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33


5.3.1 Modification procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
5.3.2 Validation procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34

5.4 Creation of a new test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36


5.4.1 Creation of a main test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
5.4.2 Creation of a dependent test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37

5.5 Test order on the TEST PANEL . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38

5.6 Test deletion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39

5.7 Test update . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40

5.8 Calculated tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43


5.8.1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
5.8.2 Description of the setup parameters for a calculated test . . . . . . . . . . . . . . 44
5.8.3 Definition of primary tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44
5.8.4 Printout / Transmission . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45
5.8.5 Definition of calculation formula . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45

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5 Test setup
Each main test is composed of 3 pages of test setup parameter definitions:
- Methodology is defined in page 1 (see chap. 5.1.1)
- Calibration is defined in page 2 (see chap. 5.1.2)
- Result printout and transmission and quality controls are defined in page 3
(see chap. 5.1.3)
Each dependent test is composed of 1 page of test setup parameter definitions.
(see chap. 5.1.4).

5.1 Description of Test Setup Parameters

5.1.1 Methodology (page 1 of 3)


Fig. 1 - Page 1 of the Test Setup

Legend:

1 Available functions:

Display of the next page

F4 Access to the DEPENDENT TESTS screen (see chap. 5.1.4)

F6 Print out of the 3 Setup pages

Esc Display of the EXIT OPTIONS window (see chap. 5.3.2).

2 Date of the last modification saved by the operator

3 Test identification

4 Sample parameter definition

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5 Diluent parameter definition

6 Reagent parameter definition

7 Analysis parameter definition

8 Result parameter definition

9 Value range definition for automatic confirmation of the results

10 Selection of automatic redilution parameters

The definition of each parameter is described in the following pages.

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5.1.1.1 Test identification

Abbreviation Main test abbreviated name.


(8 characters)

Name Main test complete name (used for


(25 characters) printout...).

Method Type of measurement method.


Choices:
Clot-based
Chromogenic:
- Kinetic 2 points,
- Kinetic O.D./minute.
Immunology:
- Kinetic 2 points,
- Kinetic O.D./minute
Calculated result:
See chap. 5.8.

5.1.1.2 Sample definition

Volume Final Sample Volume: expressed in


microliters (including dilution).
Possible choices:
from 25 µl to 200 µl by step of 5 µl.

Total volume (sample + reagents) must be


between:
- 150 µl and 400 µl for clotting methods,
- 250 µl and 400 µl for photometric
methods.

Incu. Incubation time of the plasma alone


(from 0 to 999 seconds)
0 = no incubation

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Dil. Dilution ratio.


The following options are available:

The 1/400 dilution is not possible when the


sample volume is less than 50 μl.

Reminder: Sample / Total volume


volume (sample + reagent)

1 / 6

5.1.1.3 Diluent definition

ID. Diluent identification.


(8 characters)

Name Diluent name.


(6 to 15 characters)

Vial Initial volume of the diluent vial


ml (in milliliters).

Stab. Diluent stability on the STA Satellite (in


h hours). Stability is checked when diluent is
loaded into the STA Satellite .

Min. Volume Quantity of diluent (in milliliters) below


ml which the STA Satellite stops
measurements.

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5.1.1.4 Reagent definitions (Ra, Rb, Rc, Rd)

ID. Identification of each reagent.


8 characters max., figures and letters.

Name Name of each reagent (Ra, Rb, Rc, Rd).


6 to 15 characters.

Incu. Incubation time for each reagent


sec. (from 30 to 999 seconds).
0: no incubation.
Minimum incubation time = 30 seconds
Depending on the time exceeding allowed
during incubation, you can use:
- P: critical incubation, the incubation time
can not be exceeded by more than 5
seconds
- nothing: normal incubation, the
incubation time can not be exceeded by
more than 30 seconds

When the allowed time has been exceeded,


the test is stopped and the cuvette
discarded. The test is automatically re-run.

Incubation selection for the sample (see chap. 5.1.1.2) and for each reagent must be
defined in accordance with one of the following methods:

Incubation Methods

A Sample => Incubation 1 =>+ Rd

B Sample + Ra => Incubation 1 =>+ Rd

C Sample + Ra + Rb => Incubation 1 =>+ Rd

D Sample + Ra + Rb + Rc=> Incubation 1 =>+ Rd

E Sample + Ra=> Incubation 1=> + Rb=> Incubation 2=>+ Rd

F Sample + Ra + Rb => Incubation 1=> + Rc => Incubation 2=>+ Rd

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Vol. Quantity of reagent needed for the test setup


µl in progress (in microliters).
Available choices:
from 25 µl to 200 µl by step of 5 µl.

The total volume (sample + reagents) must


be between:
- 150 µl and 400 µl for clotting methods,
- 250 µl and 400 µl for photometric
methods.

Vial Initial volume of the reagent vial (in


ml milliliters).

Stab. Stability of each reagent on the STA


h Satellite (in hours). The stability is checked
when reagents are loaded into the STA
Satellite .

Min. volume Quantity of reagent (in milliliters) below


ml which the STA Satellite stops
measurements.

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Washing ˆ Type of wash performed before and/or


before/after after each pipetting of the reagent.
• The following pre-wash options are
available:
No: no pre-wash
Special: use of a cleaning solution to be
defined (see below) and rinsing with the
STA® - Cleaner Solution (washing
solution).
• Post-wash options available are the
following:
Normal (using the STA® - Cleaner
Solution, washing solution)
Intensive: user-programmable from 10
to 25 pulses (STA®-Cleaner solution)
Special: with a cleaning solution to be
defined (see below) and rinsing with
STA®-Cleaner Solution
ˆ Washing options after each sample
pipetting:
Normal: 5 pulses (using STA®-Cleaner
Solution - washing solution)
Intensive: from 10 to 25 pulses (STA®-
Cleaner Solution)
Special: using a cleaning solution to be
defined (see below) and rinsing with
STA®-Cleaner Solution

5.1.1.5 Wash definition


" Press the Space Bar to reach the Wash definition window

Fig. 2 - Wash definition window

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Desorb Identification of the cleaning solution.


8 characters max., figures and letters.

Name Name of the cleaning solution.


6 to 15 characters.

Vial Initial volume of the used cleaning solution


ml vial (in milliliters).

Stability Stability of the decontamination solution on


h the STA Satellite (in hours). This stability
is checked when the decontamination
solution in loaded into the STA Satellite .

Min. volume Remaining volume (in milliliters) for each


ml decontamination solution below which the
STA Satellite stops measurements.

5.1.1.6 Analysis parameter definition

The following parameters differ for each measurement method.

Clotting

Min. Time Minimum time: shortest time for an


analysis.
Below this time, no result is given,
"< V min." is indicated instead.

Max. Time Maximum time: longest time for an


analysis.
Above this time, no result is given,
"> V max." is indicated instead.

Mean Time Estimated average clotting time of all


patients. It is used by the software to adjust
the throughput and to avoid traffic
problems in the measurement area.
In regular conditions risks of traffic
problems are low. However, for a test
conducted on large series of plasmas with
a very long clotting time (anti-vitamin K for
instance), the mean time must be
increased in order for the STA Satellite to
slow down the throughput.

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Clot Type Type of clot. Available options:


Normal: PT type clot
Weak: FIB type clot

Kinetic 2-point Chromogeny (or immunology)

First point Time (in seconds) between the dispensing


of the start reagent and the first point of
optical reading.

Second point Time (in seconds) between the dispensing


of the start reagent and the second point of
optical reading.

Kinetic O.D./min Chromogeny (or immunology)

Min. linearity Minimum linearity value acceptable for


each linear regression.

First point Time (in seconds) between the dispensing


of the start reagent and the first point of
optical reading.

Last point Time (in seconds) between the dispensing


of the start reagent and the last point of
optical reading.

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Kinetic 2-points immunology with graphic calibration mode: 2nd or 3rd order
polynomial

In the specific case of an immunological method in kinetic 2-point with calibration mode:
2nd or 3rd order polynomial, redilution level to use for out of range results.
Out of range results are defined as:
- ΔO.D. obtained greater than ΔO.D. obtained for the highest calibration point
or
- difference between the points in the initial plateau greater than 50 mO.D. (0.05 O.D.)

Redilution 1 Available redilution ratios are:

Redilution 2 Dose-hook effect detection. No applicable


parameter for this part. The dose-hook
effect is only activated for STAGO
barcoded reagents. (ex : STA® - Liatest®
D-Di).
If no dose-hook effect is detected, there is
no change in the management of the
"> V max.".
If dose-hook effect and "> V max." are both
detected, the test will be rerun according to
the redilution criteria.
In case the dose-hook effect remains after
the redilution 2, a technical error (err.) is
generated.

The following parameters apply to all reading methods

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Rd heating Start reagent preheating.


Available options:
YES: start reagent is preheated at 37°C in
the pipetting head just before dispensing.
For incubation methods E and F (see chap.
5.1.1.4), reagents Rb (method E) and Rc
(method F) are also preheated.
NO: no preheating

Stirring Available options:


YES: with stirring
NO: without stirring

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5.1.1.7 Results

Primary Unit Primary unit for result reporting.


Available options:

Raw: Seconds (Sec.), Delta of Optical


Density (D.O.D.) or Optical Density per
minute (O.D./min)
%: Percentage
Ratio: Ratio of patient time to reference time
g/l: Grams per liter
mg/dl: Milligrams per deciliter
ng/ml: Nanograms per milliliter
U/ml: Units per milliliter
IU/ml: International units per milliliter
µg/ml: Micrograms per milliliter
A.U.1: Arbitrary unit n°1
A.U.2: Arbitrary unit n°2
A.U.3: Arbitrary unit n°3
INR : International Normalized Ratio

Corrector Systematic multiplying factor only applied


to results expressed in primary unit.
This factor is not applied to control results.

Single/Duplicate Type of determination.


Used for the samples, the calibration
controls and the quality controls.
Available options:
Single determination (only 1 sampling)
Duplicate determination (2 samplings)

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Please refer to chap. 1.4 “Warnings regarding test settings”.

Precision Maximum difference allowed for a


duplicate determination. The deviation is
expressed in percentage (relative
deviation compared to the mean) and
applies to raw data, either to the clotting
time or to D.O.D. or O.D./min for
colorimetry and immunology:

M1 - M 2
Precision = M
x 100

- M1, M2: raw data,


- M = (M1 + M2)/2.
In the specific case of immunological tests
in kinetic-2 points, the absolute deviation,
expressed in mO.D., is used.
This parameter must be selected even for
single determination because it is
necessary for reruns. (see chap. 8.3.3. and
8.7.4).

5.1.1.8 Validation

Min. Max. Range of values (given in the primary unit)


for which result validation is automatically
performed.

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5.1.1.9 Redilution conditions


Definition of two other possible dilutions for the sample if it is outside the linearity zone.

Redilution options must be handled with great care because they are not always
compatible with the measurement principle.

Redilutions are forbidden for the following primary units:


- Raw (seconds, D.O.D. or O.D./min)
- Ratio
- INR

The rediluted result will only be given in the primary unit (use of secondary units is not
allowable in this case).

< "Low limit" Low limit of the linearity zone in primary


unit.

> "High limit" High limit of the linearity zone in primary


unit.

"Dil.1" < Options available for the redilutions:


"Dil.2" >

NO (no redilution, no limits to be defined)

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5.1.2 Calibration (page 2 of 3)


The page 2 of the test setup is different depending on the calibration mode selected.

Fig. 3 - Page 2 of the test setup for graphic mode

Fig. 4 - Page 2 of the test setup for bar coded mode

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Fig. 5 - Page 2 of the test setup for raw mode

Fig. 6 - Page 2 of the test setup for Ratio mode

Legend:

1 Available functions:

Displays next page


Displays previous page
Esc Displays the EXIT OPTIONS window
(see description in chap. 5.3.2)
2 Abbreviated and complete name of the test

3 Calibration mode definition

4 Calibrator definition or view points definition

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5 Calibration control parameter definition

6 Offset corrector plasma definition

7 Choice between Single/Duplicate calibrators

8 Offset corrector plasma definition

5.1.2.1 Calibration mode definition

Mode Choice of calibration mode.


There are seven options:
Barcoded:
- Data transmitted through bar code
labels, only for Diagnostica Stago tests
Graphic:
- Linear regression: linear regression on
at least 2 points (Y = ax + b)
- 2nd polynomial order: polynomial
regression of 2nd order on, at least, 4
points (Y = ax2 + bx + c)
- 3rd polynomial order: polynomial
regression of 3rd order on,at least, 6
points (Y = ax3 + bx2 + cx + d, only for
immunological tests)
- Hyperbolic graphic: hyperbolic
regression on at least 5 points
[Y = a + b / (x - N)]
Note : depending on the scale selected, x
or y may become log x, log y, 1
y
Non graphic:
- Raw: Raw data (expressed in the
measurement unit) : seconds, DO.D.,
or O.D./min
- Ratio : Ratio with a reference time

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5.1.2.2 View points

These parameters are only available for the bar coded calibration mode.

View points Selected points (in primary unit) that the operator
(maximum 8) wants to be displayed on the calibration screen
(see chap. 7.2.1)

5.1.2.3 Calibrator definition

These parameters are only available for graphic calibration modes (linear, 2nd order
polynom, 3rd order polynom or hyperbolic).

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ID. Identification of each calibrator.


8 characters max., figures and letters.

This identification may be the same for the


8 calibrators. In this case, only the dilution
ratios differ.

Key Only for Diagnostica Stago products.


Enables to choose the test or the reagent,
among a list corresponding to the order of
the parameters printed on the bar code
sheets.

Name Name of each of the 8 calibrators.


6 to 15 characters.

Dil. Dilution options for each calibrator:

Vial Initial volume of each calibrator vial (in


ml milliliters).

Stab. Stability of each calibrator on the STA


h Satellite (in hours). The stability is
checked when the calibrator is loaded into
the STA Satellite .

Min. volume For each calibrator, volume below which


ml the STA Satellite stops pipetting.

Calibration:
Different calibrators or one unique calibrator can be used. In both cases, the dilution
corresponding to each calibration point must be defined.

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Example 1: STA - Hepanorm H (Ref.: 00684).


Calibrator identifications and names are different, dilutions are identical.

CALIBRATOR DILUTION

ID. Name

12363 Hepanorm H0 1/1


12364 Hepanorm H3 1/1
12365 Hepanorm H6 1/1

Example 2: STA® - Unicalibrator (Ref.: 00675).


Calibrator identifications and names are identical, dilutions are different.

CALIBRATOR DILUTION

ID. Name

12350 Unicalibrator 1/10


12350 Unicalibrator 1/20
12350 Unicalibrator 1/40
12350 Unicalibrator 1/80

5.1.2.4 Scale definition

These parameters are only available for graphic calibration modes (linear, 2nd order
polynom, 3rd order polynom or hyperbolic) and bar-coded calibration mode

Measurement Definition of possible scales for the


Concentrations measurement axis and the concentration
axis. Available options:
Linear
Reverse
(only on the concentration axis)
Log

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5.1.2.5 Type of determination for the calibrators

This parameter is only available for graphic calibration modes (linear, 2nd order polynom,
3rd order polynom or hyperbolic).

Single/Duplicate Type of determination applicable to all


calibrators. Available options:
- Single (only 1 sampling)
- Duplicate (2 samplings)
In case of duplicate determination, each
point is considered as an individual value.

5.1.2.6 Offset correction

The parameters for "offset corrector" apply only to chromogenic and immunological tests,
and only for linear regression mode. This correction corrects intercept and maintains the
slope.

ID. Identification of the plasma used for offset


adjustment.
8 characters max., figures and letters.

Key Only for Diagnostica Stago products.


Enables to choose the test or the reagent
concerned among a list corresponding to
the parameter order printed on the bar
code sheet.

Name Name of the plasma used for the offset


adjustment.
6 to 15 characters.

Vial Initial volume of the vial of plasma used for


ml the offset adjustment (in milliliters).

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Stab. Plasma stability on the STA Satellite (in


hours). The stability is checked when the
plasma is loaded into the STA Satellite .

Min. volume Volume of offset corrector plasma below


ml which the STA Satellite stops
measurements.

5.1.2.7 Calibration control definition

The following parameters apply to all measurement methods and all calibration modes.

0 or 2 calibration controls can be defined. Using 2 controls enables automatic validation of


the calibration (see chap. 7.3.1). They must be defined for the barcoded tests and when an
offset corrector plasma is used.

ID. Identification of each calibration control.


8 characters max., figures and letters.

Key Only for Diagnostica Stago products,


enables to choose among a list
corresponding to the order of the
parameters printed on the bar code sheet
or the reagent concerned.

Name Name of each control.


6 to 15 characters.

Vial Initial volume of the control vial (in


ml milliliters).

Stab. Stability of each control (in hours) on the


h STA Satellite . The stability is checked
when the control is loaded into the STA
Satellite .

Min. volume Volume of control below which the STA


ml Satellite stops measurements.

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5.1.3 Result and quality control printout / transmission (page 3 of 3)


Fig. 7 - Page 3 of the test setup

Legend:

1 Available functions:

Display of the previous page

Esc Display of the EXIT OPTIONS window (see description in chap. 5.3.2).

2 Abbreviated and complete test name

3 Printout and transmission parameter definition

4 Usual value range definition

5 Printout limit definition

6 Parameter definition for each quality control

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5.1.3.1 Printout / transmission

Unit In addition to the primary unit, three


secondary units can be defined and used
for printout and/or transmission.

Primary Reminder of the primary unit as selected in


the result area of the test setup on page 1of
3.

Aux. 1 Definition of the 3 secondary units.


Aux. 2 Available options:
Aux. 3

NONE (no secondary unit)


Raw: Seconds (Sec.), Delta of Optical
Density (D.O.D.) or Optical Density per
minute (O.D./min)
%: Percentage
Ratio: Ratio of patient time to reference
time
g/l : Grams per liter
mg/dl : Milligrams per deciliter
ng/ml : Nanograms per milliliter
U/ml : Unit per milliliter
UI/ml : International unit per milliliter
µg/ml : Micrograms per milliliter
U.A.1 : Arbitrary unit n° 1
U.A.2 : Arbitrary unit n° 2
U.A.3 : Arbitrary n° 3
INR : International Normalized Ratio
Ref. : Time of the reference plasma

Conver. factor Conversion coefficient between the


primary unit and the secondary unit
concerned, when applicable.

Print Use of the primary units and secondary


units on the printout.
YES: unit used
NO: unit not used

Transmission Test Number For transmission of primary or secondary


units, the test number corresponding to the
host computer should be given, if the unit is
used. If the unit is not used, the rank is set
to 0 (F1 key).

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5.1.3.2 Usual value definition

Min. Max. Range of usual values in primary unit.

5.1.3.3 Printout limit definition

Printout limits Acceptable range of value for all results in


min. primary unit.
max.
Any result out of this range is automatically
reported either as the minimum value or as
the maximum value and is marked with an
alarm code.

5.1.3.4 Quality control


1 to 3 levels of quality controls must be defined.

ID. Identification of each quality control.


8 characters max., figures and letters.

Key Only for Diagnostica Stago products,


enables to choose among a list
corresponding to the order of the
parameters printed on the bar code sheets
or the reagent concerned.

Name Name of the control.


6 to 15 characters.

Period Definition of the time interval between two


controls (in hours).
Minimum: 1 hour
Maximum: 24 hours

Vial Initial volume of the control vial (in


ml milliliters).

Stab. Stability of the control (in hours) on the STA


h Satellite . The stability is checked when
the control vial is loaded into the STA
Satellite .

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Min. Volume. Volume of control under which the STA


ml Satellite stops measurements.

5.1.4 Dependent tests


8 dependent tests can be generated from each main test.
The dependent tests may have a dilution, a corrector and a test transmission number
differing from those defined for their main test.
Test run: with the same parameters as the main test but with a different dilution.
Result calculation: with the same calibration as the main test but with a different corrector.
Result transmission: with a transmission test number differing from the one defined for the
main test.
For example, dependent tests can be used for determination of multiple dilution factors.
" To access the DEPENDENT TESTS screen: see chap. 5.2.4.

Fig. 8 - DEPENDENT TESTS screen

Legend:

1 Available functions:

Access to the DEPENDENT TEST zone to create or modify a dependent test

F6 Printout of the screen

Esc Display of the EXIT OPTIONS window (see description in chap. 5.3.2)

2 Dependent test list

3 Recall of some parameters of the main test

4 DEPENDENT TEST zone: definition of the parameters of each dependent test

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Abbreviation Abbreviated name of the dependent test.


(8 characters)

Name Complete name of the dependent test.


(25 characters)

Dilution Dilution rate.


Avalaible options:

Corrector Systematic multiplicative factor for all


dependent test results in all units besides
measurement units.

Units Recall of the primary and secondary units.


The same units are used for the main test
and for its dependent tests.

Transmission test number For the use of primary or secondary units


for transmission, the transmission test
number corresponding to the host
computer if the unit is used. If the unit is not
used, the rank is set to 0 (F1key).

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5.2 Accessing the Test Setup parameters

5.2.1 Accessing the TEST SETUP menu


2 TEST PANEL

- If the STA Satellite is in stand-by:


Display, modification and creation of test setup are possible.

Modification of certain parameters requires:


- That the tests concerned are not present in any patient files of the working file.
- That you know the access code.

- If measurements are in progress:


Test setup display only is possible.
When a test setup is displayed, the followed message is displayed at the bottom of the screen:
"Measurements in progress - Modification not allowed - Space bar: washing window".

ACTIONS RESULTS

" Press Esc.  The MAIN MENU is displayed:

with the cursor on Status

" Press the S key.  The sub-menu is displayed:


OR
" Press key four times to move the
cursor to Setup, then confirm with
Enter.
with the cursor on Tests

" Press Enter.  The TEST SETUP screen is displayed with


the cursor on the first test.
 A yellow dot indicates the dependent
tests.

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5.2.2 Description of the TEST SETUP screen display


Fig. 9 - TEST SETUP screen display

Legend:

1 Available functions:

Access to the first page of the setup of the test on which the cursor is positioned
Esc Display of the OPTIONS window:

See description of these options in chap. 5.5, 5.6, and 5.7.

Note: when measurements are in progress, the following options are available:
Display of test setup
Esc Return to TEST PANEL

2 Screen name.

3 Name of the test selected by the cursor. For dependent tests, the initial main test it is
derived from is specified

4 List of available tests. A yellow dot indicates the dependent tests.

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5.2.3 Accessing setup screens for main tests


2 TEST SETUP screen, cursor on the first test (see chap. 5.2.1).

ACTIONS RESULTS

" Press or until reaching the desired  Desired test is selected.


main test (no yellow dot).

" Confirm with Enter.  The following window is displayed (see


description chap. 4.9.13.5):

" Type login and password.  Page 1 of 3 of the test setup is displayed,
with the cursor on the first modifiable
" Confirm with Enter.
setup parameter.

" Press .  Page 2 of 3 of the test setup is displayed,


with the cursor on the first modifiable
setup parameter.

" Press .  Page 3 of 3 of the test setup is displayed,


with the cursor on the first modifiable
setup parameter.

Leaving the setup screens without saving the changes:

" Press twice.  Page 1/3 is displayed.

" Press Esc  The EXIT OPTIONS window is displayed:

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ACTIONS RESULTS

" Press Q.  Exit without saving.


OR  Return to the TEST SETUP screen.
" Press and confirm with Enter.

To save the changes (Save before


quitting) an access code is required (see
validation procedure in chap. 5.3.2)

If you press Esc by mistake, press Esc again To cancel the exit from setup screens.

5.2.4 Accessing the dependent tests setup screen

5.2.4.1 Accessing the dependent tests setup screen


from the TEST SETUP screen

A yellow dot indicates the dependent tests.

2 TEST SETUP screen, cursor on the first test (see chap. 5.2.1).

ACTIONS RESULTS

" Press or until you reach the  Desired test is selected..


desired dependent test (yellow dot).

" Confirm with Enter.  The following window is displayed (see


description chap. 4.9.13.5):

" Type login and password.  DEPENDENT TEST screen is displayed,


cursor on the desired dependent test
" Confirm with Enter.
(see description of this screen display in
chap. 5.1.4).

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ACTIONS RESULTS

" Confirm with Enter.  Cursor on the first modifiable parameter.

5.2.4.2 Accessing the dependent tests setup screen


from the setup of the main test wanted

This access is only available from page 1 of 3 of the main test setup.

2 Page 1 of 3 of the main test setup is displayed.

ACTIONS RESULTS

" Press F4.  The DEPENDENT TEST is displayed with


the cursor on the first dependent test on
the side of the dependent test list (see
description of this screen in chap. 5.1.4).

" Press until you reach the desired  Cursor on the first modifiable parameter.
dependent test and confirm with Enter.

5.2.5 Accessing the setup parameters


2 A setup screen is displayed, with the cursor on the first parameter.
Cursor motion procedure:

ACTIONS RESULTS

key  Cursor moves to the next line.

key  Cursor moves to the previous line.

and keys  Cursor moves within the entry field of the


parameter concerned.

Enter key  Cursor moves to the next parameter.

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5.3 Setup parameter modification

Please refer to chap. 1.4 “Warnings regarding test settings”.

This procedure is possible only if:


- The STA Satellite is on stand-by (no measurement in progress),
- The operator knows the access code.
In addition, for certain parameters, this procedure requires that none of the concerned tests
is present any Patient file of the working file.

Modifying certain parameters may have very important consequences:


- invalidation of calibrations,
- deletion of quality control results.

(See description of the validation procedure in chap. 5.3.2).

Parameters displayed in grey cannot be modified.


Parameters displayed in blue or white can be modified.

2 types of parameter:
ˆ Free entry field: the parameter and the cursor are displayed in blue.
ˆ Multiple-option field: the parameter and the cursor are displayed in white, a
message saying DEL key = Modification is displayed at the bottom of the screen.

5.3.1 Modification procedure

Free entry field " Enter the new information on the


alphanumerical keyboard.
" Confirm with Enter.

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Multiple-option field Two options:


- Two choices available: the Del key
enables to switch from one option to the
other. Confirm your choice with Enter.
- Multiple choices available: the Del
key enables to open a selection
window, press or key to move the
cursor to the option wanted, then
confirm with Enter.

5.3.2 Validation procedure


2 One of the setup screens is displayed and all modifications are done.

ACTIONS RESULTS

" Press Esc.  The following window is displayed:

with the cursor on Save before quitting

" Confirm with Enter.  Check of the consistency of the


paramaters.
 If an inconsistency is detected [for
instance, the total volume (sample +
reagents) is greater than 400 μl] :
- The error window is displayed providing
the setup page number where the
inconsistency was found and a
description of the inconsistency.
ERROR - Page 1
Sample + Reagents volume
out of range [150 ......... 400] μl
Esc: Delete this message
- The software automatically displays the
setup page concerned.

" Read carefully the message displayed  The cursor automatically moves to the
then press Esc. parameter to be modified.

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ACTIONS RESULTS

" Proceed with modification(s) then  The software checks if any critical
press Esc. parameters have been modified (for
example, incubation time, reagent
volumes)
 In this case, to alert the operator about
the consequences of the modification(s),
the following window is displayed:
IMPORTANT CHANGES DETECTED
THE FOLLOWING OPERATIONS WILL BE
EXECUTED
Calibration ...
Quality control ...
Please type YES to accept
Esc = Abort
with different statements depending on
the type of parameter modified:
- Calibration: not valid
(operator must rerun calibration for the
test concerned)
- Quality controls: Delete
(for all quality control levels, results will
be deleted)
 If no critical parameter has been
modified:
- "Test saving"
- Return to the TEST SETUP screen

" In case of modification of critical  Depending on modifications:


parameters, if you accept the
- Invalidation of calibration for the test
consequences press YES then
concerned
confirm with Enter.
- Deletion of quality control results for the
test concerned
 Test setup is saved
 Return to the TEST SETUP screen

" From the TEST SETUP screen, press  A message advising the operator to
Esc and confirm with Enter. proceed to test setup saving is displayed

" Press Esc.  Return to TEST PANEL

" Proceed to test setup saving


(see chap. 4.9.5).

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5.4 Creation of a new test

Please refer to chap. 1.4 “Warnings regarding test settings”.

This procedure is possible only if:


- The STA Satellite is on stand-by (no measurement in progress),
- The operator knows the access code

For the description of the parameter setup (see chap. 5.1).

5.4.1 Creation of a main test


" Access the Test Setup screen (see chap. 5.2.1).
" Move the cursor using the key to the empty line after the last test of the list.
" Press Enter.
 The following window is displayed:

" Type login and password.


" Confirm with Enter.
 Page 1/3 of the Test setup is displayed.
" Fill in the test parameters:
- Free entry fields: enter the new information for each parameter (see chap. 5.3.1).
- Multiple-option fields: use the Del key (see chap. 5.3.1).
" When the 3 setup pages are set, proceed to validation (see chap. 5.3.2).

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5.4.2 Creation of a dependent test


" Access the TEST SETUP screen (see chap. 5.2.1).
" Move the cursor using the key to the main test the dependent test will originate from.
" Press Enter.
 The following window is displayed:

" Type login and password.


" Confirm with Enter.
 Page 1/3 of the main test setup is displayed.
" Press F4.
 The DEPENDENT TESTS screen is displayed.
" Move the cursor using the key to the empty space after the last test of the list.
" Press Enter.
" Fill in the test parameters:
- Free entry fields: enter the new information for each parameter (see chap. 5.3.1).
- Multiple-option fields: use the Del key (see chap. 5.3.1).

" Once the dependent test is set, press F10 then Esc.
 The EXIT OPTIONS window is displayed.
" Press Enter (Save and quit).
 Back to page 1/3 of the main test setup.
" Press Esc.
 The EXIT OPTIONS window is displayed.
" Press the Q key (Quit without saving)
 Back to the TEST SETUP screen.

It is not necessary and even not recommended to save the main test because the system
will reject this request if the Working Files contains the main test.

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5.5 Test order on the TEST PANEL


The display order of the tests on the screens can be defined in the Test setup screen.

The procedure is only possible if the STA Satellite is on stand-by (no measurement in
progress).

2 TEST SETUP screen displayed, cursor on the first test (see chap. 5.2.1).

ACTIONS RESULTS

" Press Esc.  The following window is displayed:

" Press the D key.  The following window is displayed:


OR
" Move the cursor to Displace test using
the key, then confirm with Enter.

" Press the key until you reach the test  The following window is displayed:
to be moved, then confirm with Enter.

with the yellow cursor next to the test to


be moved.

" Press the key or the key to move  Test order is reorganized.
the yellow cursor to the wanted
position then confirm with Enter.

" Follow the same procedure for all tests  The test order is reorganized.
to be moved then quit this procedure
 Return to the TEST SETUP screen.
with Esc.

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5.6 Test deletion

This procedure is possible only:


- For the test setup defined by the operator (Test setups predefined by Diagnostica Stago
cannot be deleted),
- If the STA Satellite is on stand-by (no measurement in progress),
- If no test concerned is present in the patient files of the Working File,
- If the operator knows the access code.

If the test deleted is a main test, all dependent tests originating from this test will also be
deleted.

2 TEST SETUP screen, cursor on the first test (see chap. 5.2.1).

ACTIONS RESULTS

" Press the key until you reach the test  The following window is displayed:
to be deleted (main test or dependent
test).
" Press Esc.

" Press the key until you reach Delete  The following window is displayed:
test and confirm with Enter.

" Type login and password (see chap.  The following window is displayed:
4.9.13.5).
TEST DELETION
" Confirm with Enter. Abbrev. XXX
Name XXX
WARNING
All dependent tests will be deleted if the
deleted test is a main test
Please type YES to confirm....
Esc = Quit

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ACTIONS RESULTS

" Type YES and confirm with Enter.  When the test deletion is done: return to
the TEST SETUP screen.

If you try to delete a test that is in progress


(test present in a patient file) the following
window will be displayed:
TEST DELETION
Abbrev. XXX
Name. XXX
Test used in Working File
CANNOT DELETE
Esc Delete this message

" Press Esc to delete the last message.  The TEST SETUP screen is displayed.

5.7 Test update

The test update is performed with a Stago test update floppy disk.
This procedure allows to update or to add tests predefined by Diagnostica Stago.
This procedure is possible only if:
- The STA Satellite is on stand-by (no measurement in progress),
- The patient files in the Working File have been deleted,
- The operator knows the access code.

When the operator wants to add tests, there must be enough empty spaces, otherwise the
operator will be asked to delete the necessary number of tests.

The test update may have important consequences:


- all dependent test from an updated main test will be deleted,
- calibration invalidation (according to modified parameters),
- deletion of quality control results (according to modified parameters).

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2 TEST SETUP screen, cursor on the first test (see chap. 5.2.1).

ACTIONS RESULTS

" Press Esc.  The following window is displayed:

" Press the U key  The following window is displayed:


OR
" Move the cursor to Update using
the key, then confirm with Enter.

" Type login and password  The UPDATE TRACK RECORD screen is
(see chap. 4.9.13.5). displayed with the following window:
" Validate with Enter.

with the cursor on Quit


 The list of tests affected by the previous
updates or creations is displayed in blue
with the modification dates.

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ACTIONS RESULTS

" Press the U key.  The following window is displayed:


OR
" Move the cursor to Update using the
key, and confirm with Enter.

If there are still patient files in the Work File,


the following window will be displayed:
TEST UPDATING
WORKING FILE NOT EMPTY
Updating cannot be completed
Delete Working File
Abort
with the cursor on Abort. The work file
can be deleted by pressing the key
and the Enter key, then by confirming
with YES and Enter.

" Insert the floppy disk into the floppy  The following message is displayed:
drive, then confirm with Enter.
File reading
Please wait
 Then the TEST UPDATE screen is
displayed.
The list of tests to be updated or created
is displayed in blue. The number of new
tests to be added is also displayed, as
well as the number of positions currently
occupied and the number of available
positions.

" Press F10.  The following message is displayed:


TEST UPDATING IN PROGRESS
Please wait
 On the UPDATE SCREEN the test display
color switches from blue to yellow
following the update or creation of the
tests.
 Then, the message changes to:
UPDATE DONE
Esc Quit

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ACTIONS RESULTS

" Press Esc.  The UPDATE TRACK RECORD screen is


displayed. The tests updated or created
during previous operations are
displayed in blue, the ones currently
created or updated are displayed in
yellow.
 The following window is displayed:

with the cursor on Quit

" Press Enter.  Return to TEST SETUP screen.

5.8 Calculated tests

5.8.1 Introduction
Calculated tests are tests for which the result is a calculation expression using one of these
2 formulas:
(R1 / R2) x k
or (R1 - R2) x k
with R1, R2: Results not limited to the printout limits expressed as raw data
(sec., ΔΟ.D. or O.D./min) for test 1 and 2 (primary tests)
Primary tests selected by the operator.
k: programmable coefficient.
A result can be given either equal to a ratio between two tests or equal to a difference.
The result unit is implicit, i.e. ratio in the case of a ratio calculation, raw data in the case of
a difference calculation. Secondary units do not have to be defined for the calculated tests.
This type of calculation is allowed only for primary tests based on the same measurement
methods (clotting, colorimetry or immunology).
Calculated tests and dependent tests cannot be used as pimary tests.
Results of the calculated tests are given only when the primary test result status is "to
confirm", "confirmed", "Dev. > tol", or "V > Vmax." (="T > Tmax.") (see status description in
chap. 8.3.2 and 8.3.3).
Moreover, they cannot be confirmed manually: their validation implicitely follows from the
primary test validation. Results of the calculated tests are tagged with the most serious of the
alarm codes and the most serious of the error codes that are assigned to the two primary tests.
Only alarm code H (result in primary unit limited to printout limit values) escapes from this rule
beacause it directly applies to the values obtained for the calculated test (see chap. 5.8.2 ).
Because of their specificity, calculated tests cannot be rerun, there is neither calibration nor
quality control for this type of tests and they cannot have dependent tests.
Procedures to access, modify or create these tests are the same as the ones described for
other types of tests (see chap. 5.2 , 5.3 and 5.4).

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5.8.2 Description of the setup parameters for a calculated test


Fig. 10 - Calculated test setup

Legend:

1 Esc Display of the EXIT OPTIONS window (see description in chap. 5.3.2)
F6 Print out of the screen

2 Test identification section (see description in chap. 5.1.1.1)

3 Primary test definition

4 Printout and transmission parameter definition

5 Calculation formula definition

6 Printout limit definition (see description in chap. 5.1.3.3)

5.8.3 Definition of primary tests

Only main tests may be selected as primary tests.


Both primary tests must be based on the same measurement method: clotting time,
colorimetry or immunology.

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Abbreviation Abbreviation of primary test 1 and primary


1 test 2 to select among the list of tests
or available on the STA Satellite .
2 Reminder : Primary test 1 and primary test
2 must be the same type of test: clot-
based, colorimectric or immunological.

Name Names of the primary test 1 and primary


test 2, they are automatically displayed
after selection of the abbreviations.

5.8.4 Printout / Transmission

The unit is implicit according to the type of calculation selected, see chap. 5.8.1.

Printout Use of the unit for printout:


YES: use of the unit
NO: no use of the unit

Transmission: Test Number To be able to transmit the result of the


calculated test, the transmission test
number corresponding to the host
computer must be defined. If the unit is not
used for transmission, the rank has to be
set to 0 (F1 key).

5.8.5 Definition of calculation formula

Formula Choice between two types of formula:


(Result 1 / Result 2) x k
(Result 1 - Result 2) x k
Reminder: Result 1 and Result 2 are
expressed in raw data (sec., O.D./min or
ΔO.D.)

Coefficient k Programmable coefficient between 0.001


and 9999.999

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Table of Contents

6 Product and sample loading .............................. 1

6.1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

6.2 Description of loading screens . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2


6.2.1 PRODUCT LOADING screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
6.2.2 SAMPLE LOADING screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

6.3 Product loading . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6


6.3.1 Complete loading . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
6.3.2 Single loading . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
6.3.2.1 Automatic bar code identification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
6.3.2.2 Manual identification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
6.3.3 Product modification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18

6.4 Sample loading . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19


6.4.1 Generalities on sample identification and test selection . . . . . . . . . . . . . . . . 22
6.4.2 Definition of a prefix . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
6.4.3 Definition of a test profile . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
6.4.3.1 Create a test profile . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
6.4.3.2 Modify a profile . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
6.4.4 Sample type . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
6.4.4.1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
6.4.4.2 Definition of the sample types . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
6.4.5 MANUAL mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
6.4.5.1 Access the MANUAL mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
6.4.5.2 Selection of a prefix . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
6.4.5.3 Bar code identification of samples and tube loading . . . . . . . . . . . . . . . . . . . . . . . . . 29
6.4.5.4 Manual identification and tube loading . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
6.4.5.5 Auto-incrementation of sample identification and tube loading . . . . . . . . . . . . . . . . . . 30
6.4.5.6 Individual test selection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
6.4.5.7 Test selection by profile . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
6.4.5.8 Test download from Host computer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33

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6.4.6 Automatic mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34


6.4.6.1 Access the AUTO mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
6.4.6.2 Prefix and first number definitions for the AUTO mode . . . . . . . . . . . . . . . . . . . . . . 36
6.4.6.3 Use of the AUTO mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
6.4.7 Sample loading with automatic display of the test list . . . . . . . . . . . . . . . . . 37

6.5 Emergency sample loading . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38

6.6 Sample or product unloading . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40


6.6.1 Product unloading . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40
6.6.1.1 Complete unloading . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40
6.6.1.2 Single unloading . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
6.6.2 Sample unloading . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44
6.6.2.1 Complete unloading . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44
6.6.2.2 Single unloading . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45

6.7 Running tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46

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Product and sample loading

6 Product and sample loading


Samples and other products (controls, calibrators, diluents, reagents, decontamination
solutions) are loaded respectively into the sample carousel or into the product carousel.

6.1 Generalities
Before loading, the following points should be checked:
- For reagents and other products (controls, calibrators, diluents and decontamination
solutions), check if there is any foam on the surface. If so, eliminate it.
- For samples, use only centrifuged tubes, check that there is enough plasma and that
there is no
foam, clot or micro-clot that may affect results. Remove samples from the STA Satellite®
as soon as all testing is complete.

During all loading and unloading operations, precautions for handling biohazardous
materials must be observed in accordance with local regulations in effect: for instance, use
of disposable gloves and elimination of biological wastes, as recommended in most
countries.

For all loading operations, handle only one tube or one vial at a time to avoid confusion.
For all products (reagents, controls, calibrators, dilution buffers and decontamination
solutions), please read carefully the package insert provided with each product and follow
the procedures described.

Loading requests can be done while the tests are running.


As soon as the tests are carried out, the following message is displayed:

This message is displayed with «beep» sounds to warn the user that the STA Satellite® is
now ready for loading.

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6.2 Description of loading screens

6.2.1 PRODUCT LOADING screen


Fig. 1 - Product loading screen display (full carousel)

Fig. 2 - Product loading screen display (single vial)

Legend:

1 Screen name, current date and time.

2 Available functions:

Esc: returns to the Test Status screen

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(List/Change): allows to modify or remove products that are already loaded (see
chap. 6.3.3)

3 Position of each product within the product carousel. The μ sign is displayed on the right
side of the position for products transferred into microtainers.

4 Identification number of each product. It is displayed in red when product is expired,


when the minimum volume is reached or when a liquid level detection problem is
detected.

5 Name of each product.

6 Remaining volume of each product. It is displayed in red when the minimum volume is
reached or when a liquid level detection problem is detected.

7 Stability for each product.

8 Lot number for each product.

9 Date and time of the end of stability for each product. It corresponds to the stability
defined in the Test setup menu (see chap. 5.1). It is displayed in red when the given
time is within this
period: end of stability minus 1 hour and end of stability. It is replaced by the word
Complete displayed in red when the end of stability is reached.

10 Product loaded during previous loading and for which the information is recorded
(Enter key - only in "completing loading" mode).

11 Entry area for the product to be loaded.

12 Information on the Normal Vol. or microvolume according to the option selected (F8).

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6.2.2 SAMPLE LOADING screen

Fig. 3 - SAMPLE LOADING screen: MANUAL mode

Fig. 4 - SAMPLE LOADING screen: AUTO mode

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Legend:

1 Screen name

2 Available functions:
Esc Options: This key opens the following window:

 For MANUAL mode:  For AUTO mode:


Change Profiles Change Profile
Change Prefix Change Prefix / First Number
AUTO mode Manual mode

Return to Loading Return to Loading


Quit Quit

Change profile(s): creates or modifies test profiles (see description in chap. 6.4.3).

Change prefix (MANUAL mode) or Change prefix/first number (AUTO mode) :

- For MANUAL mode: modifies the prefix selected by default (see chap. 6.4.5.2).
- For AUTO mode: modifies the prefix and the first number (see description in
chap. 6.4.6.2).
Auto mode: switches to the automatic mode.

Manual mode: switches to the manual mode.

Return to loading: returns to the loading screen with the cursor on zone 11
(see below).

Quit: closes the sample loading screen and returns to the test status screen.

Review/Modification: gives access to the following options:

* modifies some parameters


* Del deletes a sample tube from the sample carousel

3 Identification of the current mode (MANUAL or AUTO)

4 Selected prefix (manual mode)

5 Summary of the last 6 loadings

6 Identification (numerical or alphanumerical) of each sample. A color code helps to


distinguish the different status:

- white: normal
- yellow:STAT sample
- grey: patient file with unknown working list (waiting for download from Host computer)
- green:level detection problem
- red: patient file for which one or several tests have errors (for example, unsufficient
volume
or overdue stability)
7 Position of each sample within the sample carousel. The μ sign is displayed on the right
side of the position for samples transferred into microtainers.

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8 List of tests requested for each sample.

9 List of defined profiles (MANUAL mode).

10 Test selection list (MANUAL mode).

11 Entry area for the sample to be loaded. In the ID field, a Normal tube or Microtube
message is displayed in blue for routine tubes and in yellow for STAT samples.

12 Selected parameters for AUTO mode: test profile, prefix, first number.

6.3 Product loading

In case of modification of the volume during product loading, the volume entered must be
less than the actual volume in the vial.

For vials that require an adapter ( ∅ 18 mm vials), only use the adapters provided with
the STA Satellite®.

If loading includes more than one product that requires stirring, separate each
product with an empty spot or with a product that does not require stirring.

Two products requiring stirring cannot be placed next to each other within the
product carousel.

Controls, calibrators, diluents, reagents and decontamination solutions must be loaded


into the product carousel.

When a product lot is changed, calibration information for current reagent lots are no longer
valid. When a stabilization period of the reagents inside the STA Satellite® is required, it is
imperative to block tests concerned by these reagents before changing the products.
Refer to inserts provided with the reagents and see procedures in chap. 8.7.3.

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6.3.1 Complete loading


2TEST PANEL is displayed.

Note The Alt and Symb keys of the integrated keyboard cannot enable the opening of the
safety cover. Use any other key to confirm the opening request.

ACTIONS RESULTS

" Press Esc  The Main menu is displayed:

" Press L (Loading)  The following sub-menu is displayed:


" Or press the key to move the cursor
to Loading, then confirm by pressing
Enter

" Press the key to move the cursor to  The following window is displayed:
Products: carousel, then confirm by
pressing Enter
" Or press F3 from the TEST PANEL to
access this step directly

" Open the safety cover of the product  The following window is displayed:
carousel
" Press any key

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ACTIONS RESULTS

" Remove the product carousel from its  The following window is displayed:
location and place on a flat surface
" Load vials into the product carousel

Check that the barcode is located in the


reading zone so that the vial detection
operates correctly.

" Position the product carousel into its


location  Return to the PRODUCT LOADING screen.
The STA Satellite® detects the products
loaded into the carousel one by one
 The position, the identity, the name, the
volume and the stability of the first
Make sure that the carousel is properly
product detected are displayed on the
inserted into the turning plate.
bottom line of the PRODUCT LOADING
" Close the safety cover of the product screen with the cursor on product name
carousel

" Press Enter to confirm the name  The name is confirmed and the cursor
moves to volume

" If necessary, change the volume, press  Data transfer to the top part of the
Enter, then change stability if needed screen.
NB : stability can only be modified if the  The next position of the product carousel
volume was previously modified. is read
" Otherwise, press Enter directly
" If the product was transferred into a
microtainer, press F8 (microvolume)
and confirm with Enter
" Otherwise, confirm directly by pressing
Enter

" Proceed the same way for all products  The TEST STATUS screen is displayed
loaded

ˆ The Enter key enables the display of the vials saved during the last use of the STA
Satellite® (see procedure described below):

2PRODUCT LOADING screen.


" On the PRODUCT LOADING screen, when the fields "Identity, name, volume, stability and
end of stability" on the Previous line are filled, press Enter.
" If necessary, modify the volume and stability.
" Press Enter to confirm.

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" If the product was transferred into a microtainer, select "Microvolume" using F8.

If the end of stability is over, there is no possible modification. Product data is directly
recorded (Loading history).

ˆ For new product:


" Press the F1 key to confirm the new product.
" If necessary, modify the field data and confirm each modification with the Enter key.

6.3.2 Single loading

Never remove the product carousel from its location to process to a single vial loading.

2TEST PANEL is displayed.

Note The Alt and Symb keys of the integrated keyboard cannot enable the opening of the
safety cover. Use any other key to confirm the opening request.

ACTIONS RESULTS

" Press Esc  The Main menu is displayed:

" Press L (Loading)  The following sub-menu is displayed:


" Or press the key to move the cursor
to Loading, then confirm by pressing
Enter

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ACTIONS RESULTS

" Press the key to move the cursor to  The following window is displayed:
Products: vial, then confirm by
pressing
Enter
" Or press F2 from the TEST PANEL to
access this step directly

" Open product carousel cover  The PRODUCT LOADING screen is


" Then, press any key displayed with the first empty field
selected by default

" Select the position wanted within the  The selected position (Pos.) is displayed
product carousel using the arrows , on the bottom line of the screen
 The STA Satellite® places the selected
position in front of the barcode reader

The diameter of the position selected must


be the same as the diameter of the vial to
be inserted.
" Press Enter

" Proceed to vial loading  The STA Satellite® reads the barcode of
the
newly installed vial.

" Press Enter  Vial identification is displayed on the


screen

" Press Enter to confirm the name  The name is confirmed and the cursor
moves to volume

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ACTIONS RESULTS

" If necessary, change the volume ,  Data transfer in the top part of the
press Enter, then change stability if screen.
needed  The following window is displayed:

Stability can only be modified if the


volume was previously modified.
" Otherwise, press Enter directly
" If the product was transferred into a
microtainer, press F8 (microvolume)
and confirm with Enter
" Otherwise, confirm directly by pressing
Enter
" Proceed the same way for all products
to be loaded manually
" Press Esc

" Close the safety cover  The following window is displayed:


" Press any key

 The TEST STATUS screen is displayed

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6.3.2.1 Automatic bar code identification


2PRODUCT LOADING screen is displayed.

ACTIONS RESULTS

There are two ways to proceed:

ˆ Case #1 :  The selected position (Pos.) is displayed


on the bottom line of the screen (see
" Insert vial in front of the barcode reader zone 11 on fig. 2)
at the position previously selected
 Identification (Id.), Name (Name),
Volume (Volume), Stability (Stab.) and
lot number (Lot) of the product are
displayed (see zone 11 on fig. 2)
Check that the barcode is located in the  The cursor is on the Name field
reading zone so that the vial detection
operates correctly.
" In case of barcode reading failure,
proceed to a manual identification of
the vial (see chap. 6.3.2.2)

" Press Enter to confirm the name  Name is confirmed and the cursor
moves to volume
 The following message "Enter volume
(in ml) - Esc = Correction" is displayed
at the bottom of the screen

ˆ Case #2 :  The selected position (Pos.) is displayed


on the bottom line of the screen (see
" Select a position (Pos.) zone 11 on fig. 2)
" Enter the vial identification (Id.)  Identification (Id.), Name (Name),
Volume (Volume) and Stability (Stab.)
of the product are displayed (see
zone 11 on fig. 2)
 The cursor is on the Volume field
 The following message "Enter volume
(in ml) - Esc = Correction" is displayed
at the bottom of the screen

" If you need to change the volume, type  The cursor is on the Stab field
the new value, then confirm by
 The following message "Enter stability
pressing Enter
(in h) - Esc = Correction" is displayed
" Otherwise, confirm directly by pressing at the bottom of the screen
Enter and go to the RESULTS field below

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ACTIONS RESULTS

" Change stability if necessary, then  The cursor is on the Lot field
confirm by pressing Enter  The following message "Enter lot
number - Esc = Correction" is
displayed at the bottom of the screen
Stability can only be modified if volume was
previously modified.
 If no lot change was detected, skip the
" Otherwise, confirm by pressing Enter next two RESULTS fields below
 If a lot change is detected or if a manual
identification has been done (see
Case #2 above), the following window is
displayed:

" If the lot change is accepted, type YES,  The following window is displayed:
then confirm by pressing Enter

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ACTIONS RESULTS

" Pass the code sheet in front of the  For reagents that are not precalibrated,
reader the last entry seen below will be
displayed
 For precalibrated reagents, the 2
following windows are displayed, one
In case of failure of the barcode reading,
after the other if necessary:
enter the data printed under the bar codes
and confirm by pressing Enter at the end of
each line.

" Press Esc  Data transfer for this product in the top
part of the screen (zone 10, see
description in chap. 6.2.1)

" Follow the same procedure for the next


product

6.3.2.2 Manual identification


ˆ Manual identification of reagents/decontamination solutions/diluents

Manual identification can lead to typing errors.


It is used under complete responsibility of the user.

Type the exact identification of the product as defined in the Test setup.
(see fig.1 in chap 5.1.1).
Respect character size and special characters.

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2PRODUCT LOADING screen is displayed.

ACTIONS RESULTS

" Enter the product identification as it is  Reagent/solution identification is


defined in Test Setup page 1 of 3, then displayed
confirm by pressing Enter
 The cursor is on the Name field

" Enter the product name as defined in  The reagent/decontamination solution


Test setup page 1 of 3, then confirm by name is displayed
pressing Enter
 The cursor is on the Volume field
 The following message "Enter volume
(in ml) - Esc = Correction" is displayed
at the bottom of the screen

" Enter the product volume and confirm  The volume is displayed
by pressing Enter  The cursor is on the Stab field
 The following message "Enter stability
(in h) - Esc = Correction" is displayed
at the bottom of the screen

" Enter the product stability and confirm  The stability is displayed
by pressing Enter  The cursor is on the Lot key
 The following message "Enter lot
number - Esc = Correction" is
displayed at the bottom of the screen

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ACTIONS RESULTS

" If necessary, enter the lot number and ˆ For all reagents that do not belong to the
confirm by pressing Enter STA product line from Diagnostica
Stago, the following window is displayed:

There is no lot number for products such


as Desorb-U solution, diluents (Owren -
Koller),...

" For any reagent that require stirring,


press Y  If no lot change was detected, go directly
to the step below
" For any reagent that does not require
stirring, press N  If a lot change is detected, the following
window is displayed:

" For the STA line products from


Diagnostica Stago, follow the lot
change procedure described in chap.
6.3.2.1

" If the lot change is accepted, type YES,  The cursor in on the Normal Vol. field
then confirm by pressing Enter (zone 12, see description of the
PRODUCT LOADING screen in chap. 6.2.1)

 The following message F8 = Modify


(Normal Vol. /Microvolume) - Esc =
cancel is displayed at the bottom of the
screen

" If the reagent/decontamination solution  The Normal Vol. switches to


was transferred into a microtainer, Microvolume
press F8

" Press Enter  Transfer of the reagent/decontamination


solution data in the top part of the screen
(zone 10, see description in chap. 6.2.1)

" Follow the same procedure for the next


product

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ˆ Manual identification of controls/calibrators

2PRODUCT LOADING screen is displayed.

Type the exact identification of the product as defined in the Test setup.
(see fig.1 in chap. 5.1.1).
Respect character size and special characters.

ACTIONS RESULTS

" If control/calibrator is in its original vial,


skip the ACTIONS field below

" Enter the control/calibrator  Control/calibrator identification is


identification as it is defined in Test displayed
Setup page 1 of 3, then confirm by  The cursor in on the Name field
pressing Enter

" Enter the control/calibrator name as it is  The control/calibrator name is displayed


defined in Test Setup page 1 of 3, then
 The cursor in on the Volume field
confirm by pressing Enter
 The message "Enter volume
(in ml) - Esc = Correction" is displayed
at the bottom of the screen

" Enter the control/calibrator volume and  The volume is displayed


confirm with Enter
 The cursor is on the Stab field
 The following message "Enter stability
(in h) - Esc = Correction" is displayed
at the bottom of the screen

" Enter the stability and confirm with  The stability is displayed
Enter
 The cursor in on the Lot field
 The following message "Enter lot
number- Esc = Correction" is
displayed at the bottom of the screen

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ACTIONS RESULTS

" If necessary, enter the lot number  If no lot change is detected, go directly to
printed on the vial and confirm by the next RESULT field below
pressing Enter
 If a lot change is detected, the following
window is displayed:

For a calibrator, the following window is


displayed:

The quality control limit values must be


modified on the concerned screens,
otherwise the test will remain blocked.

" Type YES, then confirm by pressing  The following window is displayed:
Enter

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ACTIONS RESULTS

" Pass the barcode sheet in front of the  The following window is displayed:
reader
" In case of failure of the barcode reading,
enter the data printed under the
barcodes
and confirm with Enter at the end of
each
line

" Press Esc  The cursor is on the Normal Vol. field


(zone 12, see description of the
PRODUCT LOADING screen in chap.
6.2.1).
For all related tests, calibrator values or
control limit values will be properly  The message: F8 = Modify (Normal
displayed in the various screens on Vol./Microvolume) - Esc = cancel is
condition that the primary unit chosen displayed at the bottom of the screen.
for the test is identical to the one used
on the barcode sheet (except:
fibrinogen)

" Press Enter  Transfer of the control/calibrator data in


the top part of the screen (zone 10, see
description in chap. 6.2.1)

6.3.3 Product modification

This procedure is only possible for controls, calibrators, reagents, diluents or


decontamination solutions already loaded during the loading session in progress.
Possible modifications concern:
- the volume,
- the stability,
- the Normal Vol./Microvolume information.

2The PRODUCT LOADING screen is displayed


ACTIONS RESULTS

" Move the cursor to the control/  The cursor is on the control/calibrator/
calibrator/reagent/decontamination reagent/decontamination solution
solution/diluent wanted using the and wanted
keys

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ACTIONS RESULTS

" Press Enter  All the information of the control/


calibrator/reagent/decontamination
solution is displayed in the entry zone
(zone 11, see description of the
PRODUCT LOADING screen in chap. 6.2.1)

 The cursor is on the Volume field


 The following message "DEL = Deletion
of the product selected" is displayed at
the bottom of the screen

" If you need to modify the volume, enter  The new volume is displayed
the new value, then confirm by
 The cursor is on the Stab field
pressing Enter
 The following message "Enter stability
" Otherwise, confirm directly by pressing
(in h) - Esc = Correction" is displayed
Enter and go to the next RESULT field
at the bottom of the screen
below

" If necessary, modify the stability, then  The volume and the stability are
confirm by pressing Enter displayed
" Otherwise, confirm directly by pressing  The cursor is on the Normal Vol. or
Enter Microvolume field
 The following message " Enter =
modify
(F8 = Normal Vol./Microvolume) - Esc
= Cancel" is displayed at the bottom of
the screen

" If necessary, change the Normal Vol.  Transfer of the control/calibrator/


or Microvolume information using F8, reagent/decontamination solution/
then confirm by pressing Enter diluent in the top part of the screen (zone
" Otherwise, confirm modifications by 10, see description of the PRODUCT
LOADING screen in chap. 6.2.1)
pressing Enter

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6.4 Sample loading

Samples must be loaded into the sample carousel.

RISK OF INCORRECT RESULTS


Never load two tubes that have the same identity into the sample carousel (even if the
two tubes are from the same patient) to prevent results from being assigned to another
patient.

Samples must be stored outside the STA Satellite® as soon as their presence is no
longer necessary inside the analyzer.

2TEST PANEL is displayed.

Note The Alt and Symb keys of the integrated keyboard cannot command the opening of
the safety cover. Use any other key to confirm the opening request.

ACTIONS RESULTS

" Press Esc  The Main menu is displayed:

" Press the L key(Loading)  The following menu is displayed:


" Or press the key to move the cursor
to Loading, then confirm by pressing
Enter

with the cursor on Samples

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ACTIONS RESULTS

" Press Enter  The following window is displayed:


" Or press F1 from the TEST PANEL to
access this step directly

 The SAMPLE LOADING screen is


displayed

To load samples one by one into the  The STA Satellite® detects the new tube
carousel:
" Press any key
" Insert the tube into the position showed
by the STA Satellite®.
The tube barcode must be placed in
front of the reader

- If the sample has been transferred into


a microtainer, press F8
- If it is a STAT sample, press F12
- If it is a STAT sample which has been
transferred into a microtainer, press F8,
then F12
" Press any key

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ACTIONS RESULTS

To load several samples at once into the  The following window is displayed:
carousel:
" Open the sample carousel cover
" Remove the carousel from its location
and put it on a flat surface
" Load the samples into the carousel,
with the barcode labels facing the
window
" Place the carousel back in its location

 The following window is displayed:


Make sure that the carousel is properly
inserted into the turning plate.
" Close the sample carousel cover

 The STA Satellite® detects the tubes


loaded into the sample carousel.

ˆ In case of unread tubes :


- If the unread tube management is activated, an identity is automatically generated for
each unread tube (to activate this option, see chap. 10.2.2.1 and 10.2.4).
- If the unread tube management is not activated, an alarm rings for each unread tube so
the operator can manually identify the tube.
.

6.4.1 Generalities on sample identification and test selection


ˆ There are several ways to identify samples:
- Bar code identification with or without prefix,
- Manual identification with or without prefix,
- Automatic identification (with or without test selection).

ˆ There are also several ways to select tests:


- Individual selection,
- Selection by profile,
- Downloading from Host computer,
- Automatic recall of the test list.

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The number of tests is limited to 12 for each patient file.

Any combination is possible, see below:

TEST SELECTION

Individual Profile Host Automa-


computer tic recall
downloading

Manual X X X X
with prefix

IDENTIF. Manual X X X X
without prefix

SAMPLE Bar code X X X X


with prefix

Bar code X X X X
without prefix

The AUTO mode is treated separately because it comprises both the notions of prefix and test
selection.
For the automatic recall of the test list, see chap. 6.4.7.

6.4.2 Definition of a prefix


A prefix can be defined in either manual or barcode identification mode. A prefix can also be
defined either in MANUAL mode or AUTO mode.
The prefix can be used to differenciate the various kinds of samples according to the criteria
chosen by the laboratory.
For example, POP for pre-operative, HEP for a patient treated with Heparin, AVK for a
patient treated with anti-vitamin K...

6.4.3 Definition of a test profile


In MANUAL mode, up to 7 test profiles can be defined; these profiles can be modified at any
time.

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In AUTO mode, only one test profile called AUTO is used.

The number of tests for each profile is limited to 6. Several profiles can be added, the limit
is 12 tests for each Patient file (MANUAL mode).

Fig. 5 - Test profile modification screen

Legend:

1 Screen name

2 Profile list

3 Display zone for the available test list

4 List of available functions:

Modify Gives access to the following functions:

Insert/Remove Adds or deletes one or several tests


for a selected profile

0 Downloading Downloads test from the Host computer

F10 Confirms the modification or creation of profiles

Esc Returns to the first profile in the list without saving


modifications

Esc Returns to the SAMPLE LOADING screen

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6.4.3.1 Create a test profile


2 SAMPLE LOADING screen (MANUAL mode or AUTO mode) is displayed (as described in
chap. 6.2.2).

ACTIONS RESULTS

" Press Esc (Options)  For the MANUAL mode, the following
window is displayed:

 For the AUTO mode, the following


window is displayed:

In both cases, the cursor is on Quit

" Press C (Change profiles)  The TEST PROFILE MODIFICATION screen


is displayed (see description fig. 5 in this
" Or move the cursor to Change
chapter)
profiles using the key, then confirm
by pressing Enter

" Move the cursor below the last profile  The list of available tests is displayed,
using the key, then confirm by with the cursor located on the first test
pressing Enter

" Select the desired test by using the  The tests selected are displayed in zone
cursor motion keys , , , and 2 of the TEST PROFILE MODIFICATION
confirm your choice for each test by screen (see description fig. 5 of this
pressing Enter chapter)
" Or press 0 (Downloading)  By downloading is displayed in zone 2
of the TEST PROFILE MODIFICATION (see
description fig. 5 of this chapter)

" Save the test profile using F10  The profile is validated

" Press Esc  Return to the SAMPLE LOADING screen

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6.4.3.2 Modify a profile


2SAMPLE LOADING screen (MANUAL mode or AUTO mode) is displayed (as described in
chap. 6.2.2).

ACTIONS RESULTS

" Press Esc (Options)  For the MANUAL mode, the following
window is displayed:

 For the AUTO mode, the following


window is displayed:

In both cases, the cursor is on Quit

" Press C (Change profiles)  The TEST PROFILE MODIFICATION screen


is displayed (see description fig. 5 of this
" Or move the cursor to Change profiles
chapter)
using the key, then confirm by
pressing Enter

" Move the cursor to the profile to be  The TEST PROFILE MODIFICATION is
modified using the key, then confirm displayed
by pressing Enter

" Select the desired tests by using the  The tests selected are displayed in the
cursor motion keys , , , and zone 2 of the TEST PROFILE MODIFICATION
confirm your screen (see description fig. 5 of this
choice for each test by pressing Enter chapter)
" Or press 0 (Downloading)  By downloading is dispalyed in the
zone 2 of the TEST PROFILE
MODIFICATION (see description fig. 5 of
this chapter)

" Save the test profile using F10  The profile is validated

" Press Esc  Return to the SAMPLE LOADING screen

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6.4.4 Sample type

6.4.4.1 Introduction
There are several categories of samples:
- Normal samples: loaded in standard tubes with enough plasma to perform all requested
tests and non-STAT samples.
- STAT samples.
- Samples transferred into microtainers.

For both MANUAL and AUTO mode, the sample type must be specified during sample
identification using F8 for sample transferred into microtainers or using F12 for STAT
samples. A STAT sample can be transferred into a microtainer.

The STAT samples can be identified by their yellow color. For STAT sample processing, see
chap. 6.5.

6.4.4.2 Definition of the sample types


2The SAMPLE LOADING screen is displayed on MANUAL mode or on AUTO mode (see
description in chap. 6.2.2).

ACTIONS RESULTS

" If the sample is normal (neither urgent,


nor
contained in a microtainer), proceed to
its identification (see chap. 6.4.5
(MANUAL
mode) or 6.4.6 (AUTO mode))

" If it is a STAT sample, press F12  The message Normal tube switches
from blue to yellow (zone 11 on the
SAMPLE LOADING screen, see description
in chap. 6.2.2)

" If the sample has been transferred into  The message Normal tube is replaced
a microtainer, press F8 by Microtube (zone 11 on the SAMPLE
LOADING screen, see description in
chap. 6.2.2)

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ACTIONS RESULTS

" If it is a STAT sample which has been  The message Microtube is displayed in
transferred into a microtainer, press F8 yellow (zone 11 on the SAMPLE LOADING
and F12 screen, see description in chap. 6.2.2)

6.4.5 MANUAL mode

6.4.5.1 Access the MANUAL mode


This operation is not necessary if MANUAL MODE is already displayed in zone 3 (see
description of the SAMPLE LOADING screen in chap. 6.2.2).

2The SAMPLE LOADING screen is displayed with AUTO MODE displayed (as described in
chap. 6.2.2).

ACTIONS RESULTS

" Press Esc  The following window is displayed:

" Press M (MANUAL mode)  Return to sample loading with the


" Or move the cursor to MANUAL mode message MANUAL mode in zone 3 (see
using the key, then confirm by description of the SAMPLE LOADING
pressing Enter screen in chap. 6.2.2)
 The message "sample identification
(F12 = Stat/Routine F8 = Normal/
Micro tube)" is displayed at the bottom
of the screen

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6.4.5.2 Selection of a prefix


2The SAMPLE LOADING screen is displayed with MANUAL MODE displayed (as described in
chap. 6.2.2) with the message "Sample identification (F12 = Stat/Routine
F8 = Normal/Micro tube)" displayed at the bottom of the screen.

ACTIONS RESULTS

" Press Esc (Options)  The following window is displayed:

" Press C (Change prefix)  The following window is displayed:


" Or move the cursor to Change prefix
using the key, then confirm using the
Enter key

with the cursor on the entry zone for the


prefix

" To delete the current prefix, press the  Go to the last RESULT field below
key until the prefix is completely erased,
then confirm using Enter

" To define a free prefix, type the free  Return to sample loading ; the prefix
prefix desired, then confirm by selected is displayed in zone 11 (see
pressing Enter description of the SAMPLE LOADING
screen in chap. 6.2.2)
 Any manual or bar code identification will
then be preceded by this prefix
(displayed in zone 4 of the LOADING
SAMPLE screen)

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Product and sample loading

6.4.5.3 Bar code identification of samples and tube loading

The identification can be done with or without prefix.

2The SAMPLE LOADING is displayed with MANUAL mode displayed and with the cursor on
the sample entry zone (as described in chap. 6.2.2). The sample type has previously
been defined (see chap. 6.4.4.2).

ACTIONS RESULTS

" Insert the sample tube in front of the  The identification of the tube is displayed
barcode reader on the screen in the ID zone (zone 11 of
the SAMPLE LOADING screen, see
description in chap. 6.2.2)

Check that the barcode is located in the


reading zone so that the tube detection
operates correctly.

" Proceed to the test selection (see


below)

6.4.5.4 Manual identification and tube loading

The identification can be done with or without prefix.

Manual identification can lead to typing errors.


It is used under complete responsibility of the user.

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2The SAMPLE LOADING screen is displayed with MANUAL mode displayed and with the
cursor on the sample entry zone (as described in chap. 6.2.2). The sample type has
previously been defined (see chap. 6.4.4.2).

ACTIONS RESULTS

" Enter the sample identification on the  The message "Load the last tube
alphanumerical keyboard, then confirm identified - Esc = Repeat
by pressing Enter identification" is displayed at the
bottom of the screen

" Place the sample tube inside the  Automatic display of the position within
sample carousel by inserting it the carousel and the message "Enter
completely, in the position showed by tests to perform - F10 = Confirm"
the STA Satellite® (in front of the displayed at the bottom of the screen
barcode reader)

The tube has to be placed within 10


seconds, otherwise the tube will need to be
identified again.

" Proceed to the test selection (see


below)

6.4.5.5 Auto-incrementation of sample identification and tube loading


It is possible using the key.
If it is used upon opening of the carousel, the generated identification is 1.
If it is used during loading, the generated identification is the identification of the previous
file plus 1.
Example :

Previous file Generated identification

DUPONT DUPONT1

100 101

MAT100 MAT101

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2The SAMPLE LOADING screen is displayed in MANUAL mode with the cursor on the sample
entry zone (as described in chap. 6.2.2).
The sample type has previously been defined (see chap. 6.4.4.2).

ACTIONS RESULTS

" Press the key  Generated identification = 1 if no tube


has previously been loaded
 Generated identification = Identification
of the file previously loaded + 1

" Confirm the generated identification by  The message "Load the last tube
pressing Enter identified - Esc = Repeat
identification" is displayed at the
bottom of the screen

" Place the sample tube inside the  Automatic display of the position within
sample carousel by inserting it the carousel and the message "Enter
completely, in the position shown by the tests to perform - F10 = Confirm"
STA Satellite® (in front of the barcode displayed at the bottom of the screen
reader)

The tube has to be placed within 10


seconds, otherwise the tube will need to be
identified again.

" Proceed to the test selection (see


below)

6.4.5.6 Individual test selection

2Tube in progress, already identified and loaded (see above). The SAMPLE LOADING
screen with the message "Enter tests to perform - F10 = Confirm" is already displayed
and with the cursor on the first test in the Selection zone (zone 10 of the SAMPLE LOADING
screen, see description in chap. 6.2.2).

ACTIONS RESULTS

" Select the desired tests by moving the  The selected tests are displayed in the
cursor using the cursor motion keys , test selection zone for the sample
, , and confirm the selection for being loaded (zone 11 of the SAMPLE
each test by pressing Enter LOADING screen , see description in
chap. 6.2.2)

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ACTIONS RESULTS

" Save test selection using F10  Sample data transferred into the already
loaded samples zone (zone 5 of the
SAMPLE LOADING screen, see description
in chap. 6.2.2)

6.4.5.7 Test selection by profile


ˆ Profile selection using a number key (1 to 7)

2Tube in progress, already identified and loaded (see above). SAMPLE LOADING screen
with the following message "Enter tests to perform - F10 = Confirm" already displayed
with the cursor on the first test in the Selection zone (zone 10 of the SAMPLE LOADING
screen,see description in chap. 6.2.2).

ACTIONS RESULTS

" Press the key (1 to 7) corresponding to  The selected tests are displayed in the
each profile wanted test selection zone for the sample
being loaded (zone 11 of the SAMPLE
LOADING screen, see description in
chap. 6.2.2)

" Save sample using F10  Sample data transferred into the already
loaded samples zone (zone 5 of the
SAMPLE LOADING screen, see description
in chap. 6.2.2)

ˆ Profile selection using the cursor

2Tube in progress, already identified and loaded (see above). SAMPLE LOADING screen
with the following message "Enter tests to perform - F10 = Confirm" already displayed
and with the cursor on the first test in the Selection zone (zone 10 of the SAMPLE LOADING
screen, see description in chap. 6.2.2).

ACTIONS RESULTS

" Press the key  The cursor is on the first profile in the
zone for Pre-saved profiles (zone 9 of
the SAMPLE LOADING screen, see
description in chap. 6.2.2)

" Move the cursor on each profile using  The test profiles selected are displayed
the key, then confirm each profile by in the Requested tests zone for the
pressing Enter sample being loaded (zone 11 of the
SAMPLE LOADING screen, see description
in chap. 6.2.2)

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ACTIONS RESULTS

" Save sample using F10  Sample data transferred into the already
loaded samples zone (zone 5 of the
SAMPLE LOADING screen, see description
in chap. 6.2.2)

6.4.5.8 Test download from Host computer


The option by downloading can be selected through a profile (see chap. 6.4.3).
The option Verify patient data is defined in the Global Options menu (see description in
chap. 10.2.3.1).

2Tube in progress, already identified and loaded (see above). SAMPLE LOADING screen
with the message "Enter tests to perform - F10 = Confirm" already displayed and with
the cursor on the first test in the Selection zone (zone 10 of the SAMPLE LOADING screen,
see description in chap. 6.2.2).

ACTIONS RESULTS

" Press the key (1 to 7) corresponding to  By downloading is displayed in the


the profile by downloading zone Required tests for the sample
being loaded (zone 11 of the SAMPLE
" Or press the key, then the key until
DOWNLOAD screen, see description in
reaching the by downloading profile,
chap. 6.2.2)
then confirm with Enter

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ACTIONS RESULTS

" Save sample using F10  If the option Verify patient data is set to
NO, data for this sample is tranferred into
the already loaded samples zone (zone
5 of the SAMPLE LOADING screen, see
description in chap. 6.2.2)
 If the option Verify patient data is set to
YES, the following windows are
displayed:
DOWNLOADING

Please wait
Esc = Cancel
DOWNLOADED DATA

ID:1 xxx
Patient: 2 xxx xxx
xxx xxx

F10 Save Esc Cancel

Legend:

1 Patient File identification num ber

2 Additional information (Name, First


name ...), see definitions in
chap. 10.2.3.3

" If data sent back by the Host computer  Sample data transferred into the already
is correct, press F10 loaded samples zone (zone 5 of the
SAMPLE LOADING screen, see description
in chap. 6.2.2)

" If data sent back by the Host computer  The following window is displayed:
is not correct press Esc
SAMPLE LOADING

DOWNLOAD

Please check that the tube was


removed.

F10 = Confirm

" Remove the tube and confirm using


F10

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6.4.6 Automatic mode


This mode allows fast loading of samples for which:
- the test profile requested is the same,
- the identification numbers are succesive or are on barcodes.

6.4.6.1 Access the AUTO mode


This operation is not necessary if AUTO MODE is already displayed in zone 3 of the SAMPLE
LOADING screen (see description in chap. 6.2.2).

2The SAMPLE LOADING screen is displayed with MANUAL MODE displayed (as described in
chap. 6.2.2).

ACTIONS RESULTS

" Press Esc  The following window is displayed:

" Press A (AUTO MODE)  Return to SAMPLE LOADING with AUTO


MODE displayed in zone 3 (see
" Or move the cursor to AUTO mode
using the key, then confirm by description of the SAMPLE LOADING
pressing Enter screen in chap. 6.2.2)
 The following message "Enter = File
Editing (F12 = Stat/Routine
F8 = Normal/Micro tube" displayed at
the bottom of the screen

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6.4.6.2 Prefix and first number definitions for the AUTO mode
2SAMPLE LOADING screen is displayed on AUTO mode (as described in chap. 6.2.2) with
the message "Enter = File editing (F12 = Stat/Routine F8 = Normal/Micro tube)"
displayed at the bottom of the screen.

ACTIONS RESULTS

" Press Esc (Options)  The following window is displayed:

" Press C (Change prefix/first number)  The New parameters window is


displayed with the cursor on the prefix
" Or move the cursor to Change prefix/
entry zone
first number using the key, then
confirm by pressing Enter

" To delete the current prefix, press the  Go to the next RESULTS field below
key until the prefix is completely
deleted, then confirm by pressing
Enter

" To define a free prefix,type the free  The cursor is on the first number entry
prefix desired, then confirm by zone
pressing Enter

" Enter the first number, then confirm  Return to SAMPLE LOADING.
with F10  Parameters defined for the AUTO mode:
profile, prefix and first number are
displayed in the Parameters zone (zone
12 of the SAMPLE LOADING screen, as
described in chap. 6.2.2)
 The identificaton of the first sample is
displayed in the ID zone for the sample
being loaded (zone 11 of the SAMPLE
LOADING screen, see description in
chap. 6.2.2).

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6.4.6.3 Use of the AUTO mode


2The SAMPLE LOADING screen in AUTO mode is displayed and the cursor is on the Sample
entry zone (as described in chap. 6.2.2).
The sample type has previously been defined , see chap. 6.4.4.2.
The test profile has previoulsy been defined, see procedure in chap. 6.4.3.
The prefix and the first number have previoulsy been selected, see procedure in
chap. 6.4.6.2.

ACTIONS RESULTS

" Press Enter  The following message "Place the last


tube identified" is displayed in yellow
at the bottom of the screen

" Insert the tube into the position shown  Sample data automatically transferred
by the STA Satellite® into the already loaded samples zone
(zone 5 of the SAMPLE LOADING screen,
see description in chap. 6.2.2) with
automatic display of the position on the
carousel and the message
Check that the barcode is located in the "Enter= File editing (F12 = Stat/
reading zone so that the tube detection Routine F8 = Normal/ Micro tube)"
operates correctly. displayed at the bottom of the screen

" Proceed to the loading of the next tube


Reminder: the sample type can be
changed at any time.

6.4.7 Sample loading with automatic display of the test list


The automatic display of the test list is available for Patient files already known by the STA
Satellite® because they already have been loaded, processed and removed.
This automatic display is available in both MANUAL and AUTO mode.

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2The SAMPLE LOADING screen is displayed (MANUAL mode or AUTO mode) as described in
chap. 6.2.2.

ACTIONS RESULTS

" Enter the sample identification on the  The test list is displayed automatically in
alphanumeric keyboard, then confirm the Requested tests area for the tube
by pressing Enter being loaded (zone 11 of the SAMPLE
LOADING screen, see description in chap.
" Or insert the tube into the position
6.2.2)
showed by the STA Satellite®.
The tube barcode must be facing the  The message "Load the last tube
barcode reader identified - Esc = Repeat
identification" is displayed at the
bottom of the screen

" Place the sample tube into the carousel  Sample data transferred into the already
by inserting it completely, in the position loaded samples zone (zone 5 of the
showed by the STA Satellite® (in front of SAMPLE LOADING screen, see description
the barcode reader) in chap. 6.2.2) with automatic display of
the sample position on the carousel
 The STA Satellite® is ready for the next
The tube has to be placed within 10 loading
seconds, otherwise the tube will need to be
identified again.

6.5 Emergency sample loading


The STA Satellite® processes in priority samples loaded in emergency.
When the analyzer is working, sample loading is only possible when tests in progress are
done.

RISK OF INCORRECT RESULTS


Never load two tubes with the same identity into the sample carousel (even if the two
tubes are from the same patient) to prevent results from being assigned to another patient.

2TEST PANEL is displayed.

Note The Alt and Symb keys of the integrated keyboard cannot command the opening of
the safety cover. Use any other key to confirm the opening request.

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ACTIONS RESULTS

" Press Esc  The Main menu is displayed:

" Press L (Loading)  The following menu is displayed:


" Or press the key to move the cursor
to Loading, then confirm by pressing
Enter

with the cursor on Samples

" Press Enter  The following window is displayed:


" Or press F1 from the TEST PANEL to
access this step directly

 The SAMPLE LOADING screen is


displayed

" Press any key  The STA Satellite® detects the new tube
" Press F12 to indicate that the tube must  The sample status changes: it is
be processed in emergency displayed in yellow (emergency
process) on the screen

If the sample is transferred into a


microtainer and has to be processed in
emergency, press F8, then F12.

" Insert the tube to be loaded in


emergency in the position showed by
the STA Satellite®

Check that the barcode is located in the


reading zone so that the tube detection
operates correctly.

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ACTIONS RESULTS

" In the Selection zone, select tests to be  The tests selected are displayed in the
carried out on the sample loaded in Requested tests zone on the screen.
emergency (using the direction arrow
keys , , , ).
" Or select saved tests in the saved
profile zone by typing the number
corresponding to the tests or profile
selected.
" Confirm with F10

6.6 Sample or product unloading

6.6.1 Product unloading

6.6.1.1 Complete unloading


2TEST PANEL is displayed.

Note The Alt and Symb keys of the integrated keyboard cannot command the opening of
the safety cover. Use any other key to confirm the opening request.

ACTIONS RESULTS

" Press Esc  The Main menu is displayed:

" Press L (Loading)  The following sub-menu is displayed:


" Or press the key to move the cursor
to Loading, then confirm by pressing
Enter

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ACTIONS RESULTS

" Press the key to move the cursor to  The following window is displayed:
Products: Full carousel, then confirm
by pressing Enter
" Or press F3 from the TEST PANEL to
access this step directly

" Press Y  The following window is displayed:

" Open the product carousel cover  The following window is displayed:
" Remove the product carousel from its
location and put it on a flat surface
" Unload vials from the product carousel
" Press any key

" Position the empty product carousel  The following window is displayed:
into its location

Make sure the carousel is properly inserted


into the turning plate.
" Close the product carousel cover
" Press any key

 Unloaded products data are removed


from the PRODUCT LOADING screen

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6.6.1.2 Single unloading

Never remove or move the product carousel during single unloading.


If the carousel has been moved or removed, proceed to a complete loading again (see
chap. 6.3.1).

2TEST PANEL is displayed.

Note The Alt and Symb keys of the integrated keyboard cannot command the opening of
the safety cover. Use any other key to confirm the opening request.

ACTIONS RESULTS

" Press Esc  The Main menu is displayed:

" Press L (Loading)  The following sub-menu is displayed:


" Or press the key to move the cursor
to Loading, then confirm by pressing
Enter

" Press the key to move the cursor to  The following window is displayed:
Product: single vial, then confirm by
pressing Enter
" Or press F2 from the TEST PANEL to
access this step directly

" Open the product carousel cover  The PRODUCT LOADING screen is
displayed
" Then, press any key

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ACTIONS RESULTS

" Select the line which vial needs to be  The selected line is displayed in the
unloaded using the and keys. modification zone
" Press Enter  The vial is placed in front of the barcode
reader

" Remove the vial from the carousel  Unloaded vial data are removed from the
PRODUCT LOADING screen

" Press Esc  Then, the following message is


displayed:
QUIT?

YES
NO
with the cursor on YES

" Press Enter to quit  The following window is displayed:

" Close the safety cover  The TEST STATUS screen is displayed.
" Press any key

" Press Esc  Return to the TEST PANEL

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6.6.2 Sample unloading

6.6.2.1 Complete unloading


2TEST PANEL is displayed.

Note The Alt and Symb keys of the integrated keyboard cannot command the opening of
the safety cover. Use any other key to confirm the opening request.

ACTIONS RESULTS

" Press Esc  The Main menu is displayed:

" Press L (Loading)  The following menu is displayed:


" Or press the key to move the cursor
to Loading, then confirm by pressing
Enter

" Press Enter  The following window is displayed:


" Or press F1 from the TEST PANEL to
access this step directly

 The SAMPLE LOADING screen is


displayed

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ACTIONS RESULTS

" Open the sample carousel cover  The following window is displayed:
" Press any key
" Remove the sample carousel from its
location and put it on a flat surface
" Unload tubes from the sample carousel

" Position the empty sample carousel  The following window is displayed:
back into its location

Make sure the carousel is properly inserted


into the turning plate.
" Close the sample carousel cover
" Press any key

 Then the TEST STATUS screen is


displayed

" Press Esc  Return to TEST PANEL

6.6.2.2 Single unloading


2TEST PANEL is displayed.

Note The Alt and Symb keys of the integrated keyboard cannot command the opening of
the safety cover. Use any other key to confirm the opening request.

ACTIONS RESULTS

" Press Esc  The Main menu is displayed:

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ACTIONS RESULTS

" Press L (Loading)  The following menu is displayed:


" Or press the key to move the cursor
to Loading, then confirm by pressing
Enter

with the cursor on Samples

" Press Enter  The following window is displayed:


" Or press F1 from the TEST PANEL to
access this step directly

 The SAMPLE LOADING screen is


displayed.

" Press any key  The selected line is displayed in the


modification zone.
" In the File identification zone, select
the line with the vial to be unloaded  The vial is placed in front of the barcode
using the and keys reader
" Press Enter

" Remove the tube from the carousel  Data from the unloaded tube are
removed from the SAMPLE LOADING
screen.

" Press Esc  Return to the TEST STATUS screen

" Press Esc  Return to TEST PANEL

6.7 Running tests

The operator can also run or stop tests from the Status menu (see description in
chap. 10.1.5.1).

As soon as the operator confirms the test run, samples are processed as follows:
- sampling of calibrators for all tests,
- sampling of calibration controls for all tests,
- sampling of quality control for all tests,

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- sampling of STAT samples,


- sampling of samples for all tests in chronological loading order.

2The SAMPLE LOADING screen is displayed on MANUAL mode or on AUTO mode (see
description in chap. 6.2.2).
Or the PRODUCT LOADING screen is displayed (see description in chap. 6.2.1).

ACTIONS RESULTS

" Press Esc  For the sample carousel, one of the


following windows is displayed:
 For the MANUAL mode:

 For the AUTO mode

In both cases, the cursor is on Quit.


 For the product carousel, the following
window is displayed:
Quit
YES
NO

with the cursor on Yes

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ACTIONS RESULTS

" Confirm by pressing Enter  When all conditions are met (calibrations
and quality controls OK, no stability is
overdue, no insufficient volume) for all
products, sample pipetting starts again
and TEST STATUS screen is displayed.
The Esc key allows to return to the TEST
PANEL.

 If one of the conditions previously


described is not met for one or several
reagents, the sample pipetting is
blocked and the TEST STATUS screen is
displayed with the following message
"Sample pipetting blocked" displayed
on a red background at the bottom of the
screen (see description of the TEST
STATUS screen in chap. 10.1.3).

" If sample pipettings have been blocked,  The following window is displayed:
press Esc

" To reactivate tests, press Y  Authorized sample pipettings start


again.
 Return to TEST PANEL.
In this case, only tests meeting the
following conditions (right calibration, right
quality control, right volume, right stability
for all products) will be run. The other tests
will remain blocked.

" To block tests, press the N key  Return to TEST PANEL.

" According to needs:


- Load missing products,
- Change range values for controls and
calibrators which are not from the STA
product line.

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Table of Contents

7 Calibration ................................................ 1

7.1 Access to a given calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1


7.1.1 How to access a given calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
7.1.2 Description of the CALIBRATION screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2

7.2 Description of CALIBRATION screens . . . . . . . . . . . . . . . . . . . . . . . . . 3


7.2.1 Description of calibration screens: bar coded mode . . . . . . . . . . . . . . . . . . . 3
7.2.1.1 GRAPHIC CALIBRATION Screen - bar coded mode . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
7.2.1.2 CALIBRATION INFORMATION screen - bar coded mode . . . . . . . . . . . . . . . . . . . . . . . 5

7.2.2 Description of calibration screens : raw mode . . . . . . . . . . . . . . . . . . . . . . . 6


7.2.3 Description of calibration screens: ratio mode . . . . . . . . . . . . . . . . . . . . . . . 7
7.2.4 Description of calibration screens: graphic mode . . . . . . . . . . . . . . . . . . . . . 9

7.3 Procedures for running and validating calibrations . . . . . . . . . . . . . 13


7.3.1 General principles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
7.3.2 Loading standards and calibration controls . . . . . . . . . . . . . . . . . . . . . . . . . 16
7.3.3 Running and validation of bar coded calibrations . . . . . . . . . . . . . . . . . . . . . 16
7.3.4 Running and validation of calibrations in raw mode . . . . . . . . . . . . . . . . . . . 18
7.3.5 Running and validation of a ratio mode calibration . . . . . . . . . . . . . . . . . . . 20
7.3.5.1 Running and validation of a ratio mode calibration with calibration controls . . . . . . . . . . 20
7.3.5.2 Running and validation of a ratio mode calibration without calibration controls . . . . . . . 22
7.3.6 Running and validation of a graphic mode calibration . . . . . . . . . . . . . . . . . 23
7.3.6.1 Running and validation of graphic mode calibration with calibration controls . . . . . . . . . 23
7.3.6.2 Running and validation of graphic mode calibrations without calibration control . . . . . . . 26
7.3.7 Running of several calibrations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27

7.4 Procedure to observe in case of calibrations not confirmed automatical-


ly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
7.4.1 Messages displayed when calibration is not confirmed automatically . . . . . 29
7.4.2 Description of the Calibration not confirmed windows . . . . . . . . . . . . . 29
7.4.2.1 Description of the Calibration not confirmed window (out of range controls) . . . . . . 30
7.4.2.2 Description of the Calibration not confirmed window (absence of controls) . . . . . 31

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7.4.3 Confirming out of range calibration controls . . . . . . . . . . . . . . . . . . . . . . . . 31


7.4.4 Rerun controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
7.4.5 Confirming manually a calibration curve . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
7.4.6 Modifying and confirming a calibration curve . . . . . . . . . . . . . . . . . . . . . . . . 34
7.4.7 Restoring previous calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
7.4.8 Rerun calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
7.4.9 Cancel calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37

7.5 Other interventions available for confirmed calibrations . . . . . . . 38


7.5.1 Modification of 100 % point . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
7.5.2 Offset modification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40
7.5.3 Modifying measurements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
7.5.4 Printout of the calibration curve . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44
7.5.5 Modification of the ISI value . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45
7.5.6 Information screen display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46

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7 Calibration
7.1 Access to a given calibration

7.1.1 How to access a given calibration


2TEST PANEL is displayed.

ACTIONS RESULTS

" Press Esc  The Main menu is displayed:

" Press C (Calib./Control)  The following sub-menu is displayed:

" Press Enter  The CALIBRATION screen is displayed


(see description below in chap. 7.1.2),
with the cursor on the first test of the list

" Move the cursor to the test for which a  The calibration screen selected is
calibration is required using the cursor displayed (see description below in
motion keys , , , , and confirm chap. 7.2)
with Enter

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7.1.2 Description of the CALIBRATION screen


Fig. 1 - CALIBRATION screen

Legend:

1 Screen name

2 Available keys:
access to the calibration of the selected test
F1 Select calibrations to run: requests calibration run for the test on which the
cursor is
positioned
F10 Run selected calibrations: runs calibrations selected with the F1 option
(procedure for
multiple run,see chap. 7.3.7)
Esc TEST PANEL

3 List of test abbreviations with a colored square displayed on the left of the abbreviation
showing the calibration status (see point 5 below)

4 Complete name of the test on which the cursor is positioned

5 Color code to identify the status of each calibration:


- white: Confirmed
- blue: To be confirmed
- yellow: Running
- red: Not calibrated

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7.2 Description of CALIBRATION screens

7.2.1 Description of calibration screens: bar coded mode

For this mode, there are two screens:


- a graphic screen,
- an information screen.

7.2.1.1 GRAPHIC CALIBRATION Screen - bar coded mode

Fig. 2 - GRAPHIC CALIBRATION screen - bar coded mode

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Legend:

1 Screen name

2 Esc Options: displays the Options window

- Information: displays the second calibration screen (INFORMATION screen)


- Modify 100% point - ISI, available only for clotting tests:
• if the main unit is percentage
• if the measurement scale is linear
• if the concentration scale is inverse

Possible options:
• move the calibration curve in a parallel direction from itself so that the calibration goes
through the new point given in seconds and which corresponds to 100%
• have access to the ISI (Internationnal Sensitive Index) if INR (International Normalized
Ratio) was chosen as the unit

- Print (only available when the STA Satellite® is on stand-by), printout of the 2 calibration
screens: graphic and information
- Run controls allows to modify calibration control ranges if they have already been
defined and run these tests (F10 key)
- Quit: back to the CALIBRATION screen (test selection)

3 Date and time of calibration control validation

4 Control calibration results expressed in the primary result unit:

- "xxx" : waiting for calibration control results


- "---" : calibration controls in progress
- results displayed in white: calibration control results confirmed in normal conditions
- results displayed in red and preceded by an asterisk: calibration control results validated
even though they were out of range
5 ISI (International Sensitive Index) value
It is displayed only if INR (International Normalized Ratio) was selected

6 Value in seconds of the point corresponding to 100%


It is displayed only if it has been modified and if this modification is possible (see point
2 above)

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7 Raw data values (sec, O,D., O.D./ min) interpolated from the calibration curve
equation

8 Display points as defined on the TEST SETUP screens (see chap. 5.1.2.2 of the manual)

9 Graphic representation of the calibration curve

10 Equation of the calibration curve

The parameters come from the bar code reading performed if a change of the product
lot has been detected during reagent loading step (see chap. 6.3.2.1).

7.2.1.2 CALIBRATION INFORMATION screen - bar coded mode

Fig. 3 - CALIBRATION INFORMATION screen - bar coded mode

Legend:

1 Complete test name

2 Esc Quit: returns to the GRAPHIC CALIBRATION screen

3 Identification of the calibration mode

4 Identification number of each calibration control

5 Complete name of each calibration control

6 Lot number corresponding to each calibration control used during calibration

7 Minimum and maximum value for each calibration control

8 Initial range values for each calibration control

9 Identification number of each reagent

10 Complete name of each reagent

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11 Lot number corresponding to each reagent used during calibration


The box is empty if the reagent has no lot number

7.2.2 Description of calibration screens : raw mode


Fig. 4 - CALIBRATION screen - raw mode

Legend:

1 Complete name test.

2 Esc Options: displays the following window:

- Run controls enables the user to:


• modify the calibration control ranges if they have already been defined,
• run these tests (F10 key).

- Print (only available when the STA Satellite® is on stand-by), printout of the screen as
displayed above.
- Quit: back to the calibration screen (test selection)

3 Identification of the calibration mode

4 Date and time of the calibration control validation, if they are used.
If not, the box is empty.

5 Calibration control results expressed in the primary result unit:

- empty zone: calibration controls have not been defined

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- "xxx" : waiting for the calibration control results


- "---" : calibration control in progress
- results displayed in white: calibration control results confirmed in normal conditions
- results displayed in red and preceded by an asterisk: calibration control results validated
even though they were out of range

If calibration controls are used:


6 Identification number of each calibration control
7 Complete name of each calibration control
8 Lot number corresponding to each calibration control used during calibration
9 Minimum and maximum value for each calibration control

10 Minimum and maximum initial value for each calibration control

11 Identification number of each reagent

12 Complete name of each reagent

13 Lot number corresponding to each reagent used during calibration. The box is empty if
the reagent has no lot number

7.2.3 Description of calibration screens: ratio mode


Fig. 5 - CALIBRATION screen - ratio mode

Legend:

1 Complete test name.

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2 Esc Options: displays the following window:

- Change reference time/range enables the user to:


• enter the reference time
• modify the calibration control ranges (if used)
• run calibration controls (if used, F10 key)

- Print (only available when the STA Satellite® is on stand-by), printout of the screen as
displayed above
- Quit: back to the calibration screen (test selection)

3 Identification of the calibration mode

4 Date and time of the calibration control validation, if they are used.
If not, the box is empty.

5 Reference time entered by the operator

6 Calibration control results expressed in primary result unit:

- empty zone: calibration controls not defined


- "xxx" : waiting for the calibration control results
- "---" : calibration control in progress
- results displayed in white: calibration control results confirmed in normal conditions
- results displayed in red and preceded by an asterisk: calibration control results validated
even though they were out of range

If calibration controls are used:


7 Identification number of each calibration control
8 Complete name of each calibration control
9 Lot number corresponding to each calibration control used during calibration
10 Minimum and maximum value for each calibration control

11 Minimum and maximum initial value for each calibration control

12 Identification number of each reagent

13 Complete name of each reagent

14 Lot number corresponding to each reagent used during calibration.


The box is empty if the reagent has no lot number.

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Calibration

15 ISI (International Sensitive Index) value is displayed only if INR (International


Normalized Ratio) was selected

7.2.4 Description of calibration screens: graphic mode

For this mode, there are two screens:


- a graphic screen,
- an information screen.

Fig. 6 - GRAPHIC CALIBRATION screen


for clotting tests - graphic mode

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Fig. 7 - GRAPHIC CALIBRATION screen


for photometric tests - graphic mode

Legend:

1 Complete test name

2 Esc Options: displays the Options window:

For clotting tests For photometric tests

- Information: displays the second calibration screen (INFORMATION screen)


- Modify 100% point - ISI, available only for clotting tests:
• if the main unit is percentage
• if the measurement scale is linear
• and if the concentration scale is inverse

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Possible options:
• move the calibration curve in a parallel direction from itself so that the calibration goes
through the new point given in seconds and which corresponds to 100%
• have access to the ISI (Internationnal Sensitive Index) if INR (International Normalized
Ratio) was chosen as the unit

Modify Offset: this option is available for photometric tests in linear graphic mode and for
which the offset corrector and the calibration controls have already been defined
This option enables the user to:
• modify parameters on the INFORMATION screen if necessary
• launch offset correction (calibration in 1point) with F10
• move the calibration curve in a parallel direction from itself so that the calibration goes
through the new point given by the offset correction plasma

- Print (only available when the STA Satellite® is on stand-by), printout of the 2 calibration
screens: GRAPHIC and INFORMATION
- Calibrate: modify the parameters of the INFORMATION screen if necessary and run the
calibration (F10 key)
- Modify measurements: deletion or modification of calibration points
- Quit: back to the CALIBRATION screen (test selection)

3 Date and time of calibration control validation

4 Calibration control results expressed in the primary result unit:

- empty zone: calibration controls have not been defined


- "xxx" : waiting for the calibration control results
- "---" : calibration control in progress
- results displayed in white: calibration control results confirmed in normal conditions
- results displayed in red and preceded by an asterisk: calibration control results validated
even though they were out of range

5 ISI (International Sensitive Index) value. It is displayed only if INR (International


Normalized Ratio) was selected

6 Value in seconds of the point corresponding to 100%. It is displayed only if it has been
modified and if this modification is possible (see point 2 above)

7 Offset: value in OD./min or in .O.D for the offset corrector plasma if it has been run
(see description of the Modifying offset option, chap. 7.5.2)

8 Theoretical concentration of standards expressed in the primary unit

9 For coagulation tests: clotting time measured in seconds.


For colorimetric and immunologic tests: .O.D or O.D./min
A S is displayed on the left of suppressed values and a M is displayed on the left of
modified values

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10 Standard values after interpolation from the equation found for the calibration curve
(expressed in the primary result unit)

11 Graphic representation of the calibration curve

12 Equation of the calibration curve

13 Regression coefficient

FIG. 8 - CALIBRATION INFORMATION screen


for chronometric tests - graphic mode

Fig. 9 - CALIBRATION INFORMATION screen


for photometric tests - graphic mode

Legend:

1 Complete test name

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Calibration

2 Esc Quit: returns to the GRAPHIC CALIBRATION screen

3 Identification number of each calibrator

4 Complete name of each calibrator

5 Lot number corresponding to each calibrator used during calibration

6 Dilution ratio for each calibrator, defined in the test setup menu (see chap. 5.1.2.3)

7 Concentration of each calibration point (primary result unit)

If calibration controls are used:


8 Identification number of each calibration control
9 Complete name of each calibration control
10 Lot number corresponding to each calibration control used during calibration
11 Minimum and maximum values for each calibration control
12 Minimum and maximum initial values for each calibration control

13 Identification number of each reagent

14 Complete name of each reagent

15 Lot number corresponding to each reagent used during calibration


The box is empty if the reagent has no lot number

16 Identification number, complete name and lot number of the offset corrector plasma.
For clotting tests, this zone remains empty

7.3 Procedures for running and validating calibrations

7.3.1 General principles


Calibrations can be run:
- one by one from the calibration screen of each test selected (see chap. 7.3.3 to 7.3.6),
- globally from the CALIBRATION screen (test list, see chap. 7.3.7).

The calibrations can be run only if the sample pipetting is not blocked:
- on the TEST STATUS screen (see chap. 10.1.3),
- on the Stop Sample Pipetting function of the Status sub-menu
(see chap. 10.1.5.1).
Blocking tests through the Global Modification menu does not block calibrations (see
chap. 8.7.3).

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There are 7 different calibration modes:

Mode Calibrate

Barcoded " Run the 2 calibration controls.


The reading of the calibration parameters is
performed during reagent loading (see chap.
6.3.2.1).

Only for some Diagnostica


Stago tests.

Raw " Run the 2 calibration controls if they have been


defined on the TEST SETUP screens.

Ratio " Enter the reference time value.


" Run the 2 calibration controls if they have been
defined on the TEST SETUP screens.

Linear graphic " Run standards.


Polynomial order 2 graphic " Run the 2 calibration controls if they have been
Polynomial order 3 graphic defined on the TEST SETUP screens.
Hyperbolic graphic

Calibration modes, as well as all calibration parameters (definition of standards,


definition of calibration controls, scales...) are defined on the TEST SETUP screen (see
chap. 5.1.2).

ˆ Calibration controls:
The calibrations are automatically validated.
Once calibration controls are run, 2 control levels are mandatory, one level will not provide
an accurate slope.
Once the calibration controls are defined, they are run in single or duplicate, according to
the determination mode selected for the sample (see chap. 5.1.1.7).
ˆ Standards:
Standards can be run in single or duplicate, according to the determination mode selected
on the test setup screens (see chap. 5.1.2).

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As soon as calibration control results are obtained, they are compared to the acceptance
range. If they are outside the acceptance range, the calibration should be validated
manually.

If the operator decides to accept out of range calibration controls, the results for these tests
will be displayed in red and preceded by an asterisk on the related CALIBRATION screen (see
chap. 7.2).

If the same controls are used for calibration controls and quality controls:

- The calibration control results are integrated in the quality control results;
- The clock for quality control are reset while running the calibration controls (see
chap. 9.4.1)

Caution: in this case, calibration controls and quality controls have the same identification
number.

If running has been requested for one or several calibrations or calibration controls, when
the operator quits the CALIBRATION screen (test selection), the STA Satellite® performs a
consistency check and displays the TEST STATUS screen.
When running a calibration, if the necessary products are missing (missing or present but
with stability level and volume not valid), the calibration are not run, missing products are
displayed in red on the TEST STATUS screen and the sample pipetting are blocked (see
chap. 10.1.3).

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7.3.2 Loading standards and calibration controls


Standards and calibrations controls must be loaded into the product carousel (see chap.
6.3.2).

Make sure that the carousel is properly inserted into the turning plate.

For each new lot number, standard concentrations and/or calibration control range values
of the STA product line from Diagnostica Stago are read by means of the reading of the
barcode included in each product box.
For other products, those values must be entered manually.

For products of the STA product line from Diagnostica Stago, standard and range values
are properly dispatched in the related tests on condition that the primary unit selected for
this test is identical to the one defined on the inserts included in each product box (except
Fibrinogen: for the primary unit g/l, values are properly dispatched even if they are given in
mg/dl on the package insert).

7.3.3 Running and validation of bar coded calibrations


The parameters of the calibration curve are read while reagent is loaded for any new lot
number.
Calibration must be confirmed by 2 calibration controls that will ensure that the STA
Satellite® has not drifted from STA Satellite® reference analyzer.
When closing the product carousel cover:
- If calibration controls are already loaded, the calibration status for the related test
switches to In progress on the TEST STATUS screen. Calibration controls are
automatically run by the STA Satellite® if sample pipetting has not been blocked by the
operator.
- If not, calibration control are run automatically as soon as they are loaded and if the
operator has not blocked sample pipetting.
If the results of the 2 calibration controls are outside the expected ranges, the calibration
must be confirmed manually, then the patient tests will be run.
The 2 calibration controls results are displayed in the GRAPHIC SCREEN part for the test
concerned (see chap. 7.2.1).

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If one or several calibration control results are outside the expected ranges, the operator will
be warned by an error message displayed and will be given several possibilities (see chap.
7.4).

The operator may also run calibration controls at any time on its own will (see below).

2Screen of bar coded calibration displayed (as described in chap. 7.2.1).

ACTIONS RESULTS

" Press Esc  The following window is displayed:

" Press R (Run controls)  The following window is displayed:

" Identify yourself (see chap. 4.9.13.5).  The second screen (INFORMATIONS
screen) is displayed (see chap. 7.2.1.2).
 The cursor is positioned for a potential
modification of the minimum range for
the first calibration control (see
description of the INFORMATION screen in
chap. 7.2.1.2, zone 17 ).

" If necessary, modify each range value,  The cursor moves to the next range.
then confirm using Enter
" Otherwise, press Enter to go from one
range to the other

" When all range values are correct,  Return to the selected calibration
press F10 screen.
 Calibration controls are run
automatically by the STA Satellite® on
condition that the consistency check
does not lead to blocking of the sample
pipetting.

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ACTIONS RESULTS

" Press Esc  Return to the CALIBRATION screen (test


list).
 The colored square, on the left of the
abbreviation of the selected test is
displayed in yellow (calibration in
progress).
 If the calibration control results are within
the expected ranges:
- Automatic calibration validation
- The colored square, on the left of the
abbreviation of the selected test is
displayed in white (confirmed
calibration) when the CALIBRATION
screen is displayed (Test list).

 If calibration controls are outside the


expected ranges: an error message is
displayed (see chap. 7.4).

7.3.4 Running and validation of calibrations in raw mode

For raw mode, there is no calibration: the only possible function is, for a new lot, to
confirm the reagent(s) of the method by running the 2 calibration controls if they have
been previoulsy defined.
If the results for the 2 calibration controls are within the expected ranges, the
calibration is confirmed automatically, then the patient tests will run.
If calibration control results are outside the expected ranges, the operator will be
warned by an error message displayed and will be given several possibilities (see
chap. 7.4).
If calibration controls are not used, the calibration status is confirmed by default.

2Raw mode calibration screen (as described in chap. 7.2.2).

ACTIONS RESULTS

" Press Esc  The following window is


displayed:

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Calibration

ACTIONS RESULTS

" Press R (Run controls)  The following window is displayed:

" Identify yourself (see chap. 4.9.13.5).  The cursor is positioned for a potential
modification of the minimum range for
the first calibration control (zone 9, see
chap. 7.2.2).

" If necessary, modify each range value,  The cursor moves to the next range.
then confirm using Enter
" Otherwise, press Enter to go from one
range to the other

" When all range values are correct,  Return to the selected calibration
press F10 screen.
 Calibration controls are run
automatically by the STA Satellite® on
condition that the consistency check
does not lead to blocking of the sample
pipetting.

" Press Esc  Return to the CALIBRATION screen (test


list).
 The colored square, on the left of the
abbreviation of the selected test is
displayed in yellow (calibration in
progress).
 If the calibration control results are within
the expected ranges:
- Automatic calibration validation
- The colored square, on the left of the
abbreviation of the selected test is
displayed in white (confirmed
calibration) when the CALIBRATION
screen is displayed (Test list).

 If calibration controls are outside the


expected ranges: an error message is
displayed (see chap. 7.4).

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7.3.5 Running and validation of a ratio mode calibration

For the ratio mode, calibration consists in entering the reference time, then validating
the reagent(s) used for the method by running 2 calibration controls if they have been
previously defined.
If the results for the 2 calibration controls are within the expected ranges, the
calibration is confirmed automatically, then the patient tests will run.
If calibration control results are outside the expected ranges, the operator will be
warned by an error message displayed and will be given several possibilities (see
chap. 7.4).

7.3.5.1 Running and validation of a ratio mode calibration with calibration controls
2 Ratio mode calibration screen displayed (as described in chap. 7.2.3).

ACTIONS RESULTS

" Press Esc  The following window is displayed:

" Press M (Modify reference time/  The following window is displayed:


range)

" Identify yourself (see chap. 4.9.13.5).  The following window is displayed:

 The cursor is positioned for a potential


modification of the reference time (see
description of the screen in chap. 7.2.3 ,
zone 5).

" Modify the reference time if necessary,  The cursor is positioned for a potencial
then confirm using Enter modification of the minimum range for
first calibration control (see description
" Otherwise, confirm using Enter
of this screen in chap. 7.2.3, zone 10)

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Calibration

ACTIONS RESULTS

" Modify each range value if necessary,  The cursor moves to the next range.
then confirm using Enter  If the INR unit has not been selected, go
" Otherwise, press Enter to go from one to the last but one ACTIONS case below.
range to another  If the INR unit has been selected among
secondary units, the cursor moves for a
potential modification of the ISI value
(see description of this screen in chap.
7.2.3 , zone 15).

" Modify the ISI value, then confirm  ISI value is displayed.
using Enter

" When all modifications are done, press  Return to calibration screen concerned.
F10
 Calibration controls are run
automatically by the STA Satellite® on
condition that the consistency check
does not lead to blocking of the sample
pipetting.

" Press Esc  Return to the CALIBRATION screen (test


list).
 The colored square, on the left of the
abbreviation of the selected test is
displayed in yellow (calibration in
progress).
 If the calibration control results are within
the expected ranges:
- Automatic calibration validation
- The colored square, on the left of the
abbreviation of the selected test is
displayed in white (confirmed
calibration) when the CALIBRATION
screen is displayed (Test list).

 If calibration controls are outside the


expected ranges: an error message is
displayed (see chap. 7.4).

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7.3.5.2 Running and validation of a ratio mode calibration without calibration controls

2Ratio mode calibration screen displayed (as described in chap. 7.2.3).

ACTIONS RESULTS

" Press Esc  The following window is displayed::

" Press M (Modify reference time/  The following window is displayed:


range)

" Identify yourself (see chap. 4.9.13.5).  The following window is displayed:

 The cursor is positioned for a potential


modification of the reference time (see
description of this screen in chap. 7.2.3,
zone 5).

" Modify the reference time if necessary,  If the INR unit has not been selected,
then confirm using Enter skip the ACTIONS box below and go to
the next one.
" Otherwise, confirm using Enter
 If the INR unit has been selected among
secondary units, the cursor moves for a
potential modification of the ISI value
(see description of this screen in chap.
7.2.3 , zone 15).

" If necessary, modify the ISI value, then  The ISI value is displayed.
confirm using Enter

" Confirm modifications using F10  Return to the CALIBRATION screen (test
list).
 The colored square on the left of the
abbreviation of the related test is
displayed in white (confirmed
calibration).

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Calibration

7.3.6 Running and validation of a graphic mode calibration

For graphic mode, calibration consists in running standards, then running calibration
controls, if they have been previously defined.
If the results for the 2 calibration controls are within the expected ranges, the calibration
is confirmed automatically, then the patient tests will run.
If calibration control results are outside the expected ranges, the operator will be warned
by an error message displayed and will be given several possibilities (see chap. 7.4).
If calibration controls are not used, calibration validation will be done manually (see
chap. 7.4).

7.3.6.1 Running and validation of graphic mode calibration with calibration controls

2Screen of displayed graphic mode calibration (as described in chap. 7.2.4.).

ACTIONS RESULTS

" Press Esc  For clotting tests, the following window is


displayed:

 For photometric tests, the following


window is displayed:

 In both case, the cursor is on Quit.

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ACTIONS RESULTS

" Move the cursor to Calibrate using the  The following window is displayed:
key, then confirm using Enter

" Identify yourself (see chap. 4.9.13.5).  The second screen (INFORMATIONS
screen) is displayed (see chap. 7.2.4. ).
 The cursor is positioned for a potential
modification of the first standard
concentration (see chap. 7.2.4, zone
20).

" Modify the concentration of the first  For standards with the same
standard if necessary, then confirm identification, concentrations are
using Enter calculated and displayed automatically.
" Otherwise, confirm using Enter  The cursor is on the second standard.

" If you need to modify other standard  For standards with the same
concentrations, modify them, then identification, concentrations are
confirm using Enter calculated and displayed automatically
 The cursor moves to the next standard
or to the minimum range value of the first
calibration control.

" Move the cursor on the minimum range  The cursor moves to the next range.
value for the first calibration control,
modify each range if necessary then
confirm using Enter
" Otherwise, press the key to go from
one range to another

" When all parameters are correct,  Return to the selected calibration
confirm using F10 screen.
 Standards and then calibration controls
are run automatically by the STA
Satellite® on condition that the
consistency check does not lead to
blocking of the sample pipetting.

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ACTIONS RESULTS

" Press Esc  Return to the CALIBRATION screen (test


list).
 The colored square, on the left of the
abbreviation of the selected test is
displayed in yellow (calibration in
progress).
 If the calibration control results are within
the expected ranges:
- Automatic calibration validation
- The colored square, on the left of the
abbreviation of the selected test is
displayed in white (confirmed
calibration) when the CALIBRATION
screen is displayed (Test list).

 If calibration controls are outside the


expected ranges: an error message is
displayed (see chap. 7.4).

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7.3.6.2 Running and validation of graphic mode calibrations without calibration control

2Screen of displayed graphic mode calibration (as described in chap. 7.2.4.).

ACTIONS RESULTS

" Press Esc  For clotting tests, the following window is


displayed:

 For photometric tests, the following


window is displayed:

 On both cases, the cursor is on Quit.

" Move the cursor to Calibrate using the  The following window is displayed:
key, then confirm using Enter

" Identify yourself (see chap. 4.9.13.5).  The second screen (INFORMATIONS
screen) is displayed (see chap. 7.2.4).
 The cursor is positioned for a potential
modification of the concentration for the
first standard (see description of this
screen in chap. 7.2.4, zone 20 ).

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Calibration

ACTIONS RESULTS

" Modify the concentration of the first  For standards with the same
standard if necessary, then confirm identification, concentrations are
using Enter calculated and displayed automatically.
" Otherwise, confirm using Enter  The cursor moves to the second
standard.

" If other standards concentrations need  For all standards with the same
to be modified, modify them, then identification, concentrations are
confirm using Enter calculated and displayed automatically

" When all parameters are correct,  Return to the screen of the calibration
confirm using F10 selected.
 Standards are run by the STA Satellite®
on condition that the consistency check
does not lead to blocking of the sample
pipetting.

" Press Esc  Return to the CALIBRATION screen (test


list).
 The colored square, on the left of the
abbreviation of the test concerned, is
displayed in yellow (calibration in
progress).
 When the calibration is done, an
information message is displayed.

7.3.7 Running of several calibrations

This function is only available for tests pre-programmed by Diagnostica Stago because it
implies that no invervention of the operator is necessary to modify standard concentrations
and/or calibration controls. It is only possible for bar coded products (standards, controls)
for which value transfer is processed automatically. .

Calibration running requests will be refused in the following conditions:


- Raw mode calibration without calibration controls,
- Ratio mode calibration without calibration controls or with reference time not defined
- "in progress" or "to be confirmed" calibration status.

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2CALIBRATION screen (test list) displayed (as described in chap. 7.1.2).

ACTIONS RESULTS

" For each test for which calibration is  The letter S is displayed in grey on the
requested, move the cursor on its left of each test abbreviation for which
abbreviation, then press F1 calibration was requested.
Note: To cancel the run request, press
F1.

" When all calibrations wanted are  The following window is displayed:
marked with the letter S, press F10

" Identify yourself (see chap. 4.9.13.5).  On the CALIBRATION screen (test list):
- The S letters are removed,
- The colored square, on the left of the
abbreviation of the selected test is
displayed in yellow (calibration in
progress).

 Standards and calibration controls are


run automatically by the STA Satellite®
(if necessary) on condition that the
consistency check does not lead to
blocking of the sample pipetting

" Press Esc  The TEST STATUS screen is displayed


(see chap. 10.1.3).
 If the calibration control results are within
the expected ranges:
- Automatic calibration validation
- The colored square, on the left of the
abbreviation of the selected test is
displayed in white (confirmed
calibration) when the CALIBRATION
screen is displayed (Test list).

 If calibration controls are outside the


expected ranges: an error message is
displayed (see chap. 8.4)
 If calibration controls are not used (see
chap. 8.4).

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7.4 Procedure to observe in case of calibrations not confirmed


automatically
Possible reasons for non confirmed calibrations:
- calibrations out of range
- no calibration controls

In the case of calibrations in graphic mode, as long as the reagent lot number has not been
changed, the new calibration is displayed in yellow and the old calibration in grey. Raw
data, curve equation and regression coefficient are the ones of the new calibration curve.

7.4.1 Messages displayed when calibration is not confirmed automatically


In the 2 cases (see above), the operator is warned by a message:
- out of range calibration controls:
MEASUREMENT MANAGEMENT
Error 05.06.06
CALIBRATION CONTROL
the control is out of range
for the xxx
Esc = continue
xxx : abbreviation of the related test

- absence of control:
MEASUREMENT MANAGEMENT
Error 05.06.10
CALIBRATION
calibration is ready to be confirmed
for the xxx
Esc = continue
xxx : abbreviation of the related test

7.4.2 Description of the Calibration not confirmed windows


These windows are displayed when selecting a calibration for which the status requires
validation (blue square displayed on the left of the test abbreviation).

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7.4.2.1 Description of the Calibration not confirmed window (out of range controls)

Fig. 10 - Calibration not confirmed window (out of range controls)

Legend:

1 Identification number of calibration controls

2 Calibration control results, with a recall of the primary unit. Out of range results are
displayed in red.

3 Recall of the minimum and maximum ranges for each calibration control

4 List of available functions :


Confirm: validate out of range controls (see chap. 7.4.3).

Rerun controls: reruns calibration controls (see chap. 7.4.4 ).


Restore previous curve: returns to previous calibration if no lot change is detected
(see chap. 7.4.7).

Rerun calibration: reruns calibration (see chap. 7.4.8).

Cancel calibration operation:cancels calibration in case of a lot change (see chap.


7.4.9).

Postpone decision: return to CALIBRATION screen (test list).

The name of the functions is displayed in blue when they are available and in grey when
they are not available.
By default, the cursor is on Postpone decision.

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7.4.2.2 Description of the Calibration not confirmed window (absence of controls)


CALIBRATION NOT CONFIRMED
ABSENCE OF CONTROLS
Confirm
Modify / Confirm
Restore previous curve
Rerun
Cancel calibration
Postpone decision

List of available functions:


Confirm: confirms calibration manually (see chap. 7.4.5).
Modify / Confirm: modifies some raw data, than confirms calibration manually (see chap.
7.4.6 ).
Restore previous curve: returns to previous calibration if no lot change is detected (see
chap. 7.4.7).
Rerun calibration: reruns calibration (see chap. 7.4.8).
Cancel calibration: cancel calibration in the case of a lot change (see chap. 7.4.9).
Postpone decision: return to CALIBRATION screen (test list).
The name of the functions is displayed in blue when they are available and in grey when
they are not available.
By default, the cursor is on Postpone decision.

7.4.3 Confirming out of range calibration controls

This procedure requires an access code (see chap. 1.5).

If for a given test, calibration controls are confirmed even though they are out of range,
then the results for these controls are displayed in red on the related CALIBRATION
screen (see chap. 7.2).
In the Calibration not confirmed (out of range controls) window, out of range results
are displayed in red and the ranges for each control are recalled (see chap. 7.4.2.1).

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2Screen of the selected calibration displayed with the Calibration not confirmed (out of
range controls) window and the cursor on Postpone decision (see chap. 7.4.2.1).

ACTIONS RESULTS

" Move the cursor to Confirm using the  The following window is displayed:
key then confirm using Enter

" Identify yourself (see chap. 4.9.13.5).  Date, time, and calibration control
results are updated on the calibration
screen related .
 Out of range calibration control results
are displayed in red.

" Press Esc and confirm using Enter  Return to the CALIBRATION screen (test
list).
 The colored squaren, on the left of the
test abbreviation is displayed in white
(calibration confirmed).

7.4.4 Rerun controls

This function is available if calibration controls have been defined.

2Screen of the selected calibration displayed with the Calibration not confirmed (out of
range controls) window and the cursor on Postpone decision (see chap. 7.4.2.1).

ACTIONS RESULTS

" Reload products (reagents, standards,  The following window is displayed:


diluents, controls) if necessary
" Press R (Rerun controls)

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Calibration

ACTIONS RESULTS

" Identify yourself (see chap. 4.9.13.5).  The Calibration controls in progress
window is displayed.
 Calibration controls are rerun by the STA
Satellite® on condition that the
consistency check does not lead to
blocking of the sample pipetting.

" Press Esc  Return to CALIBRATION screen (Test list).


 The colored square, on the left of the test
abbreviation is displayed in yellow
(calibration in progress).

" Press Esc  The TEST STATUS screen is displayed


(see chap. 10.1.3).

7.4.5 Confirming manually a calibration curve

This procedure is available only if calibration controls are not used.

2Related calibration screen displayed with the Calibration not confirmed (absence of
controls) window and the cursor on Postpone decision (see chap. 7.4.2.2).

ACTIONS RESULTS

" Move the cursor on Confirm with the  The following window is displayed:
key then confirm using Enter

" Identify yourself (see chap. 4.9.13.5).  The Calibration not confirmed
(absence of controls) window is
removed.

" Press Esc then confirm using Enter  Return to CALIBRATION screen (Test list).
 The colored square, on the left of the test
abbreviation is displayed in white
(calibration confirmed).

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7.4.6 Modifying and confirming a calibration curve

This procedure requires an access code (see chap. 1.5).

This procedure is only available if calibration controls are not used.

2Related calibration screen displayed with the Calibration not confirmed (absence of
controls) window and the cursor on Postpone decision (see chap. 7.4.2.2).

ACTIONS RESULTS

" Move the cursor to Modify/Confirm  The following window is displayed:


using the key then confirm using
Enter

 The cursor in on the first calibration data


point

" To delete values: move the cursor to the  A yellow S is displayed next to the
value(s) to be deleted using the key deleted value(s).
then press Del
 The deleted value is displayed in grey.

Depending on the regression type, a


minimum number of calibration points
should remain:
2 for linear regression,
4 for polynomial 2 order regression,
5 for hyperbolic regression,
6 for polynomial 3 order regression.

Note : A value can be restored by


pressing F5

" To modify values: move the cursor to  The modified value(s) are displayed.
the value(s) to be modified using the
key, then proceed modification(s) and
confirm using Enter

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ACTIONS RESULTS

" When modifications are done, confirm  The following window is displayed:
using F10

" Identify yourself (see chap. 4.9.13.5).  The new calibration is recalculated then
the new calibration curve, the new
equation and the new regression
coefficient are displayed.
 A yellow S is systematically displayed
next to the deleted value(s) and a yellow
M is displayed next to the modified
value(s).
 The deleted value(s) are always
displayed in grey.

" Press Esc, then Enter  Return to CALIBRATION screen (Test list).
 The colored square, on the left of the test
abbreviation is displayed in white
(calibration confirmed).

7.4.7 Restoring previous calibration

This procedure requires an access code (see chap. 1.5).

This procedure is only available if the calibration was performed with the same reagent
sets as the ones used previously.

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2Related calibration screen displayed with the Calibration not confirmed (out of range
controls or absence of controls) window and the cursor on Postpone decision

ACTIONS RESULTS

" Move the cursor to Restore previous  The following window is displayed:
calibration using the key then
confirm using Enter

" Identify yourself (see chap. 4.9.13.5).  The Calibration not confirmed window
is removed.
 The screen of the selected calibration is
displayed again with the previous
calibration curve and all associated
parameters (equation, regression
coefficient, measured values,
interpolated concentrations).

7.4.8 Rerun calibration

This procedure is not available for bar coded calibrations.

2Related calibration screen displayed with the Calibration not confirmed (out of range
controls or absence of controls) window and the cursor on Postpone decision

ACTIONS RESULTS

" Reload products (reagents, controls,  The following window is displayed:


diluents, standards) if necessary
" Move the cursor to Rerun calibration
using the key then confirm using
Enter

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Calibration

ACTIONS RESULTS

" Identify yourself (see chap. 4.9.13.5).  The Calibration in progress window is
displayed.
 Standards (and calibration controls if
used) are rerun by the STA Satellite® on
condition that the consistency check
does not lead to blocking of the sample
pipetting.

" Press Esc  Return to CALIBRATION screen (Test list).


 The colored square, on the left of the test
abbreviation is displayed in yellow
(calibration in progress).

" Press Esc  The TEST STATUS screen is displayed


(see chap. 10.1.3).

7.4.9 Cancel calibration

This option is displayed only if the calibration was performed with a new reagent lot
number.

2Related calibration screen displayed with the Calibration not confirmed (out of range
controls or absence of controls) window and the cursor on Postpone decision.

ACTIONS RESULTS

" Move the cursor to Cancel calibration  The Calibration not confirmed window
using the key then confirm using is removed.
Enter
 The calibration curve is removed.
 A red square is displayed next to the
abbreviation of the test for which
calibration status is not calibrated.

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7.5 Other interventions available for confirmed calibrations

7.5.1 Modification of 100 % point

This procedure requires an access code (see chap. 1.5).

This option is available for clotting tests with % as primary unit and with a linear
measurement scale and an inverse concentration scale. It enables the user to move the
calibration curve in a parallel direction from itself so that the calibration goes through the
new point given in seconds and which corresponds to 100%.

2Selected calibration screen displayed with the Options window (cursor on Quit).

ACTIONS RESULTS

" Move the cursor to Modify 100% Point  The following window is displayed:
- ISI using the key then confirm using
Enter

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ACTIONS RESULTS

" Type the access code then confirm  The following window is displayed:
using Enter

 The cursor is on the entry zone for:


• The ISI value if INR has been chosen as
another unit (see description of the
CALIBRATION screen (bar coded mode) in
chap. 7.2.1, zone 5 and of the
CALIBRATION screen (graphic mode) in
chap. 7.2.4).
• Modification of the 100% point (see
description of the CALIBRATION screen
(bar coded mode) in chap. 7.2.1, zone 6
and of the CALIBRATION screen (graphic
mode) in chap. 7.2.4).
In this last case, skip the ACTIONS field
below.

" Move the cursor using the key  The cursor is on the entry zone for:
The modification of the 100% point (see
description of the CALIBRATION screen
(bar coded mode) in chapitre 7.2.1, zone
6 and of the CALIBRATION screen
(graphic mode) in chap. 7.2.4).

" Type in seconds the time corresponding  The selected calibration screen is
to the 100% value of the laboratory then displayed with the previous curve
confirm using Enter displayed in a yellow dotted curve and
the new curve displayed in yellow.
 In the curve equation, the slope is kept
and the intercept is recalculated.
 Interpolated concentrations are
recalculated

" Save modifications using F10  If calibration controls are defined, they
are rerun automatically by the STA
Satellite® on condition that the
consistency check does not lead to
blocking of the sample pipetting.

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ACTIONS RESULTS

" Press Esc  Return to CALIBRATION screen (Test list).


 If calibration controls have been defined,
the colored square on the left of the
related test abbreviation is displayed in
yellow (calibration in progress).
 If calibration controls have not been
defined, the colored square on the left of
the related test abbrevation is displayed
in white (calibration confirmed).

" Press Esc  If calibration controls have been defined,


the TEST STATUS is displayed (see chap.
10.1.3).
 If calibration controls have not been
defined, return to the TEST PANEL.

7.5.2 Offset modification

This function is available for photometric tests (chromogenic or immunological) with


linear graphic calibration mode for which offset corrector and calibration controls have
been defined.
It enables the user to move the calibration curve in a parallel direction from itself so that
it goes through the new point measured by the offset corrector plasma.

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Calibration

2CALIBRATION screen is displayed for photometric tests with the Options window.

ACTIONS RESULTS

" Move the cursor to Offset correction  The following window is displayed:
using the key then confirm using
Enter

" Type your acces code then confirm  A screen similar to the Information page
using Enter (see chap. 7.2.4) is displayed instead of
the information on the standard,
information on the offset corrector
plasma.
 The cursor is positioned for a potential
modification of the offset corrector
plasma concentration

" Modifiy offset corrector plasma  The cursor moves to the minimum range
concentration if necessary then value for the first calibration control
confirm using Enter

" Modify each range if necessary, then  The cursor moves to the next range
confirm using Enter

" When all parameters are correct,  Return to the selected calibration
confirm using F10 screen.
 Offset corrector plasma and calibration
controls are run automatically by the
STA Satellite® on condition that the
consistency check does not lead to
blocking of the sample pipetting.

" Press Esc  Return to CALIBRATION screen (Test list).


 The colored square, on the left of the
abbreviation of the selected test is
displayed in yellow (calibration in
progress).

" Press Esc  The TEST STATUS screen is displayed


(see chap. 10.1.3)

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When the calibration is confirmed:


- The new calibration curve is displayed in yellow,
- The previous curve is displayed in a yellow dotted curve,
- The interpolated concentrations are recalculated,
- The reading corresponding to the offset corrector plasma is displayed next to Offset
(zone 7 , see chap. 7.2.4).

7.5.3 Modifying measurements

This procedure requires an access code (see chap. 1.5).

This procedure is also available for calibrations whose status is to be confirmed (see
chap. 7.4.6)

2Calibration screen displayed with the Options window, the cursor is positioned on Quit.

ACTIONS RESULTS

" Move the cursor to Modify raw data  The following window is displayed:
using the key then confirm using
Enter

" Identify yourself (see chap. 4.9.13.5).  The following window is displayed:

 The cursor is on the first calibration data


point.

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Calibration

ACTIONS RESULTS

" To delete values: move the cursor to the  A yellow S is displayed next to the
value(s) to be deleted using the key deleted value(s).
then press Del  The deleted value(s) are displayed in
Depending on the regression type, a grey.
minimum number of calibration points
should remain:
2 for linear regression,
4 for polynomial 2 order regression,
5 for hyperbolic regression,
6 for polynomial 3 order regression.
Otherwise the curve will not be
displayed.
Note: A value can be restored by
pressing F5

" To modify values: move the cursor to  The modified value(s) are displayed.
the value(s) to be modified using the
key, then proceed modification(s) and
confirm using Enter

" When all modifications are done, press  The new calibration is recalculated then:
F10 the new calibration curve, the new
equation and the new regression
coefficient are displayed.
 A yellow S is systematically displayed
next to the deleted value(s) and a yellow
M is displayed next to the modified
value(s).
 The deleted value(s) are always
displayed in grey.

" Press Esc, then press Enter  Return to CALIBRATION screen (Test list).
 If calibration controls have been defined,
they are run automatically by the STA
Satellite® if the consistency check does
not lead to sample pipetting blocking.

" Press Esc  If calibration controls have been defined,


the TEST STATUS screen is displayed
(see chap. 10.1.3)
 If calibration controls have not been
defined, return to TEST PANEL.

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7.5.4 Printout of the calibration curve

This function is only available if the STA Satellite® is on stand-by (no measurement in
progress) and if all printouts of patient files previoulsy generated have been performed.

One or two screens are printed according to the calibration mode (for detail, see
descriptions of the calibration screen for each calibration mode in chap. 7.2.1. to 7.2.4).

2Related calibration screen displayed with the Options window (cursor on Quit).

ACTIONS RESULTS

" Move the cursor to Print using the key  The following window is displayed:
then confirm using Enter

" Press Enter (Execute)  The message «Printout in progress» is


displayed at the bottom of the screen.
 An asterisk is printed on the left of each
out of range calibration control result.

" When the printout is complete, press  The Printout window is removed.
Esc  Return to selected calibration screen.

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7.5.5 Modification of the ISI value

RISK OF INCORRECT RESULTS


The ISI value for the Prothrombin should correspond to the ISI value indicated on the
product insert.
The ISI value must be checked in case of any lot change, any software update or any
major change.
A wrong ISI value leads to inaccurate INR (International Normalization Ratio) results.

This procedure requires an access code (see chap. 1.5).


The ISI (International Sensitivity Index) value is modified differently depending on the
calibration mode:
- for ratio modes, it can be accessed through the Modify reference time function (see
chap. 7.3.5),
- for graphic and bar coded modes, see procedure below.

2Related calibration screen displayed with the Options window (cursor on Quit).

ACTIONS RESULTS

" Move the cursor to Modify 100% point  The following window is displayed:
- ISI using the key then confirm using
Enter

" Identify yourself (see chap. 4.9.13.5).  The following window is displayed:

 The cursor in on the ISI value entry zone


(see description of the CALIBRATION
screen (bar coded mode) in chap. 7.2.1,
zone 5 and of the CALIBRATION screen
(graphic mode) in chap. 7.2.4).

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ACTIONS RESULTS

" Type the new ISI value then confirm  The new ISI value is displayed next to ISI
using F10 coefficient (see description of the
CALIBRATION screen (bar coded mode) in
chap. 7.2.1, zone 5 and of the
CALIBRATION screen (graphic mode),
chap. 7.2.4).

7.5.6 Information screen display

This function is available bar coded calibration mode or graphic calibration mode (linear,
hyperbolic, polynomial 2nd order or polynomial 3rd order).

2Related calibration screen is displayed with the Options window (cursor on Quit).

ACTIONS RESULTS

" Move the cursor to Information using  The INFORMATION screen is displayed
the key then confirm using Enter (see description of this screen in chap.
7.2.1 and 7.2.4).

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Table of Contents

8 Patient file management .................................. 1

8.1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

8.2 Confirmation/Printout/Transmission Menu . . . . . . . . . . . . . . . . . . . . 2


8.2.1 Access CONFIRMATION/PRINTOUT/TRANSMISSION MENU . . . . . . . . . . . . . 2
8.2.2 Description of the CONFIRMATION/PRINTOUT screen . . . . . . . . . . . . . . . . . 3
8.2.3 File selection (CONFIRMATION/PRINTOUT screen) . . . . . . . . . . . . . . . . . . . . 4
8.2.3.1 Access the FILE SELECTION window . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
8.2.3.2 Description of the FILE SELECTION window (CONFIRMATION/PRINTOUT screen) . . . . . . . 4
8.2.3.3 Change selection (CONFIRMATION/PRINTOUT screen) . . . . . . . . . . . . . . . . . . . . . . . . 5
8.2.4 Exiting the CONFIRMATION/PRINTOUT screen . . . . . . . . . . . . . . . . . . . . . . . 7

8.3 Processing of a Patient file from the Working file . . . . . . . . . . . . . . . 7


8.3.1 Access a given file . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
8.3.2 Description of the FILE PROCESSING for the Working File . . . . . . . . . . . . . . 8
8.3.3 Description of possible processings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
8.3.4 Description of results in test panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
8.3.4.1 Display of tests results on single determination sample . . . . . . . . . . . . . . . . . . . . . . . 13
8.3.4.2 Display rules of tests results on double determination sample . . . . . . . . . . . . . . . . . . 15
8.3.4.3 Display rules for calibration point results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
8.3.4.4 Display rules for a calibration control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
8.3.4.5 Display rules for quality control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
8.3.5 File processing procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
8.3.6 Add complementary information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
8.3.7 Add a non-standard note . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
8.3.8 Use a standard note . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
8.3.9 Create (or modify) standard notes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

8.4 Transmit results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19


8.4.1 Conventions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
8.4.2 Generalities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
8.4.3 Online transmission . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20

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Table of Contents

8.4.4 File selection transmission . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20


8.4.4.1 Access the File Transmission window . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
8.4.4.2 Description of the File transmission window . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
8.4.4.3 Run Patient file transmission . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22

8.5 Patient file printout . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23


8.5.1 Generalities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
8.5.2 Printer selection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
8.5.3 Printout examples (internal printer) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
8.5.4 Access Printout window . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
8.5.5 Description of the printout window . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
8.5.6 Description of the printout parameters for the external printer . . . . . . . . . 28
8.5.7 Define printout parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
8.5.8 Online printout . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
8.5.9 Patient file selection printout . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
8.5.10 Printout examples on the external printer . . . . . . . . . . . . . . . . . . . . . . . . . . 32

8.6 Deleting patient files from the Working File . . . . . . . . . . . . . . . . . . 34


8.6.1 Access the file deletion window . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
8.6.2 Description of the file deletion window . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
8.6.3 Deletion procedure of Patient files from the Working File . . . . . . . . . . . . . 37
8.6.4 Deletion procedure of the entire Working File . . . . . . . . . . . . . . . . . . . . . . 38

8.7 General file modification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38


8.7.1 Access the FILE MODIFICATION screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
8.7.2 Description of the FILE MODIFICATION screen . . . . . . . . . . . . . . . . . . . . . . 39
8.7.3 Block or unblock tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40
8.7.4 Rerun or delete tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42

8.8 Customer file printout on the external printer . . . . . . . . . . . . . . . . 44


8.8.1 Generalities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44
8.8.2 Access the CUSTOMER PRINTOUT OF CONFIRMED FILES window
(Option available on the external printer only) . . . . . . . . . . . . . . . . . . . . . . 44

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8.8.3 Description of the CUSTOMER PRINTOUT OF CONFIRMED FILES screen . . 45


8.8.4 Setup customer printout . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
8.8.4.1 Customer printout format . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
8.8.4.2 Access PRINTOUT SETUP screens . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49
8.8.4.3 First PRINTOUT SETUP screen (Customer printout menu) . . . . . . . . . . . . . . . . . . . . . 49
8.8.4.4 Second PRINTOUT SETUP screen (Customer printout menu) . . . . . . . . . . . . . . . . . . . 51
8.8.4.5 Modification of the customer printout definition parameters . . . . . . . . . . . . . . . . . . . 52
8.8.5 File selection for customer printout . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53
8.8.5.1 Access the File selection window (customer printout) . . . . . . . . . . . . . . . . . . . . . . 53
8.8.5.2 Description of the file selection window (customer printout) . . . . . . . . . . . . . . . . . . 53
8.8.5.3 Change selection (customer printout) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54
8.8.6 File selection printout (customer printout) . . . . . . . . . . . . . . . . . . . . . . . . . 54

8.9 Work list download . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56

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8 Patient file management


8.1 Introduction
The STA Satellite continuously manages a file containing 600 Patient files: the Working
File.
When created, any Patient file is stored in the Working File whether the corresponding tube
is loaded
into the sample carousel or not.
The following operations are available on the patient files:
- Test or file validation
- File printout
- File transmission to a host computer
- Deletion of tests within Patient files
- Test rerun (on-board tubes only)
- Insertion of tests in the files (on-board tubes only)
- Change from non-urgent to STAT and vice versa
- Deletion of Patient file selection
- Addition of complementary information (last name, first name, ...) on the files

All these operations can be performed:


- either directly from the TEST PANEL by moving the cursor to the desired file,
- or from the File menu, CONFIRMATION/PRINTOUT screen.
Several tests at the same time may be blocked, unblocked, deleted or rerun (see chap.8.7).

8.2 Confirmation/Printout/Transmission Menu

This menu gives access to the Patient files of the Working File.

8.2.1 Access CONFIRMATION/PRINTOUT/TRANSMISSION MENU


2TEST PANEL is displayed.

ACTIONS RESULTS

" Press Esc  The Main menu is displayed:

with the cursor on Status.

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ACTIONS RESULTS

" Press F(Files)  The following Files menu is displayed:

With the cursor on Confirmation/


Printout/Transmission.

" Press Enter  CONFIRMATION/PRINTOUT menu is


displayed with the selected test list (see
chap.8.2.2).

8.2.2 Description of the CONFIRMATION/PRINTOUT screen


Fig. 1 - CONFIRMATION/PRINTOUT screen

Legend:

1 List of available keys:

Opens the file on which the cursor is positioned (see chap. 8.3)

F6 Prints out the file on which the cursor is positioned

Esc Options, displays the following window:

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Change file selection: selects a Single or a group of Patient files by Identity or with a
filtering prefix if necessary (see chap. 8.2.3).
Transmit selection: transmits file selection (see chap.8.4.4).
Print: prints out file selection (see chap. 8.5.9).
Quit: returns to TEST PANEL

2 Complementary information (last name, first name, ..., see description in chap.
10.2.3.3) for the
file on which the cursor is positioned

3 Recall of the color meaning and of the number of files corresponding to each category
for the entire Working File.

4 List of selected files:

- Two letters (T and P) confirm that the file was transmitted (T) or/and printed (P).
The 2 letters may not be displayed at all (no printout and no transmission performed) or
may be displayed simultaneously (file transmitted and printed).
- A colored square shows the status of each file:
Blue: confirmed file
White: complete file
Red: complete file with error
Yellow: incomplete file (including not loaded tubes and tubes loaded but not processed
yet)

8.2.3 File selection (CONFIRMATION/PRINTOUT screen)

8.2.3.1 Access the FILE SELECTION window


2CONFIRMATION/PRINTOUT screen is displayed (see chap.8.2.1).

ACTIONS RESULTS

" Press Esc  The following sub-menu is displayed:

with the cursor on Quit.

" Press C (Change file selection)  The Test selection window is displayed
(see chap.8.2.3.2) with the cursor on
" OR move the cursor to Change file
selection using the key, then zone 1.
confirm by pressing Enter

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8.2.3.2 Description of the FILE SELECTION window (CONFIRMATION/PRINTOUT screen)


Fig. 2 - File selection windows (CONFIRMATION/PRINTOUT screen)

Legend:

1 Identification of the first file selected

2 Identification of the last file selected

3 List of available keys:

F1 "Start" displays the first file among the test list in chronological order of all files
available in the Working File

F2 "End of list" displays the last file among the test list in chronological order of all files
available in the Working File

F3 Selects files with the cursor within the available test list

F10 Executes and displays the selection

Esc Returns to the CONFIRMATION/PRINTOUT screen

Moves the cursor to the different parameters

4 Filtering prefix identification

5 Category of the files wanted, the Enter key displays or removes the colored square
corresponding to the category of the file wanted. This function allows a better filtering.

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8.2.3.3 Change selection (CONFIRMATION/PRINTOUT screen)


2File selection window on the CONFIRMATION/PRINTOUT screen displayed (see chap.
8.2.3.2).

ACTIONS RESULTS

" Type the identification of the first file of  Identification of the first file in the
the desired selection, then confirm by selected list or "Start" is displayed in
pressing Enter zone 1.
" OR press F1 to display "Start" The cursor is on zone 2.
(corresponding to the first file (the (See description of the file selection
oldest) of the Working file). window above in chap.8.2.3.2).

" OR press F3 to select files using the


cursor: in this case, use arrow keys to
move the cursor to the desired test, then
confirm by pressing Enter

It is impossible to use the F1/F2 and F3


keys at the same time.

" Type the identification of the last file of  Identification of the last file in the
the desired selection, then confirm by selected list or "end of list" is displayed
pressing Enter in zone 2.
" OR press F2 to display the "end of list" The cursor is on zone 4.
(corresponding to the last file (the latest) (See description of the File selection in
of the Working File). chap.8.2.3.2).

" To select the last file with the cursor,


use the arrow keys to move the cursor
to the desired file, then confirm by
pressing Enter

It is impossible to use the F1/F2 and F3


keys at the same time.

" To filter, type the prefix identification,  Filtering prefix identification is displayed
then confirm by pressing Enter (If the in zone 4 (if used).
cursor is not on zone 4, move it using The cursor is on zone 5. (See
the key) description of the File selection window
" OR type the first digit(s) or letter(s) of in chap.8.2.3.2).
the Patient file identifications, then
confirm by pressing Enter
" OR leave the zone empty (no prefix
definition) and confirm by pressing
Enter

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ACTIONS RESULTS

" To improve filtering, press Enter to  The colored square is displayed next to
display a colored square next to the type the type of desired file.
of file to select. If the square is already
displayed, move the cursor using the
key

" If a type of file is not wanted, press  The colored square disappears.
Enter to remove the colored square

" When all parameters of the selection  The new selection is displayed on the
are set, press F10 CONFIRMATION/PRINTOUT screen (see
chap.8.2.2).

8.2.4 Exiting the CONFIRMATION/PRINTOUT screen


2CONFIRMATION/PRINTOUT screen is displayed (see procedure in chap. 8.2.1 and 8.2.2).

ACTIONS RESULTS

" Press Esc  The following sub-menu is displayed:

with the cursor on Quit.

" Confirm by pressing Enter  If no test has been added or rerun in the
Patient file: return to TEST PANEL.
 If tests have been added or rerun in
some Patient files, the TEST STATUS
screen is displayed (see chap. 10.1.3).

8.3 Processing of a Patient file from the Working file

8.3.1 Access a given file


There are two options:
- either from the TEST PANEL,
- or from the CONFIRMATION/PRINTOUT screen on condition that the file wanted is present
within the list of selected files, otherwise, a new file selection must be performed (see
chap. 8.2.3).

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2 TEST PANEL or CONFIRMATION/PRINTOUT is displayed with the selected test list (see chap.
8.2.1).

ACTIONS RESULTS

" Move to the desired file using the or  The cursor is on the desired file.
keys

" Confirm by pressing Enter  The FILE PROCESSING screen for the
Working File is displayed. (See
description below).

8.3.2 Description of the FILE PROCESSING for the Working File


Fig. 3 - FILE PROCESSING screen from the CONFIRMATION/PRINTOUT screen

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Fig. 4 - FILE PROCESSING screen from the TEST PANEL screen

Legend:

1 Recall of the filtering selected (see Fig. 3)

2 Recall of the validation limits for the test on which the cursor is positioned.

3 Raw data (time, O.D./min. or ∆.O.D.) and final results in primary unit for each
determination and for the mean, for the test on which the cursor is positioned.
In case of a duplicate determination, the STA Satellite compares the difference between two
values using the PRECISION parameter defined on the first page of the test setup (see
description in chap. 5.1.1.7 ).
If the difference measured is greater than the defined difference, the STA Satellite
reruns automatically a third test, compares the three results and keeps the best pair of
results.

4 List of available keys (see chap. 8.3.3).

5 File status

ˆ On the left of the line:


Confirmed: all tests in the files are done and confirmed
Complete: all tests in the file are done but some of them have not been confirmed
Complete/Error: all tests in the file are done but some tests have an error
Incomplete: some tests (or all tests) in the file have not been run, the file does not
contain any test (downloading file), or file without tube

ˆ In the center of the line:


STAT: is displayed in yellow for the STAT samples

ˆ On the right of the line:


Transmitted: the file has been transmitted

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Printed: the file has been printed


Transmitted/Printed: the file has been transmitted and printed

6 File identification

ˆ On the left of the first line:


Identification number with color codes in order to distinguish the different status (identical
to the ones used on the TEST PANEL) :
White: Routine sample (tube loaded or not)
Yellow: STAT sample (tube loaded or not)
Grey: File for which the tube has been loaded but the test list is unknown (waiting for
download from host computer)
Green:Liquid level detection error
Red: Error detected on one or several tests from the file

ˆ On the right of the first line:


- For Patient files with loaded tube: position of the tube into the sample carousel
- For patient file without tube: empty area

ˆ On the second line:


Complementary information (last name, first name, etc.).
(see description of the GLOBAL OPTIONS sub-menu in chap.10.2.3.3).
These pieces of information are either transmitted by the host computer or defined by
moving the cursor to this area (see procedure in chap.8.3.6).

7 Test list from the file. An asterisk (*) will be displayed on the left of the tests with alarm(s)
(see point 12 below).

8 For each test, mean of the result in the primary unit

9 For each test, mean of the result in the first secondary unit

10 For each test, mean of the result in the second secondary unit

11 For each test, result status:

- Blocked
- Deleted
- Waiting
- In progress
- To be validated
- Tech. err. (technical error)
- Value > max. (equivalent to > V max. displayed on the TEST PANEL)
(see description in chap.3.3.1)
- Value < min. (equivalent to < V min. displayed on the TEST PANEL)
(see description in chap. 3.3.1)
- Dev. > tol., [Dev. > tolerance (for double determination)]

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- Linearity, [< R min. (for colorimetric and immunological tests)]


- QNS (quantity of plasma not sufficient)
- Rerun
- Validated

For each test, the zones 7, 8, 9,10 and 11 are displayed in a specific color depending on
the status
of the result :
- Blue: Validated
- White: To be validated,
- Black: Waiting,
- Grey: Rerun,
- Red: Error.

12 For the test on which the cursor is positioned, alarm type(s) are displayed, if necessary :

A Raw value greater than the maximal value predefined.


C Out of range quality control or quality control not performed.
D Out of range quality control, but confirmed by the operator.
G The operator decided to ignore the alarm emitted by the STA Satellite when the
liquid level detected was not sufficient.
H Result in primary unit shown with a limit predefined in the test setup.
I Result obtained with redilution, redilution level and starting conditions are defined
in the test setup.
J Test rerun by the operator.
K Product carousel temperature is out of range but the operator decided to continue.
M One of the necessary products for the test that required stirring has not been
stirred.

The alarms are classified by order of priority: the first one is fully displayed, the other ones
are symbolized by alphabetical codes.

13 Adds a note or selects a note from the note types by pressing F9 (see procedure in
chap. 8.3.7 to 8.3.9).

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8.3.3 Description of possible processings


Other files: the previous file is displayed, the next file is displayed.

Esc List: returns to the CONFIRMATION/PRINTOUT screen (not available from TEST PANEL).

Esc Quit: returns to TEST PANEL if no test has been added or rerun, or displays the TEST
STATUS screen if one or several tests have been added or rerun (see description of
this screen in chap.10.1.3).

F1 Confirm file: all results with status to be confirmed change to confirmed


When saving (F10 key), if all result status are confirmed, then the file status changes
to CONFIRMED.

F2 Accept test: the status of the test on which the cursor is positioned changes to
confirmed status only if its initial status allows it: to be confirmed, difference >
tolerance or V > V max. (when it is equivalent to T > T max.).

F3 Rerun test: the test on which the cursor is positioned will be rerun. Its status changes
to rerun.

In case of a duplicate determination, the result is rerun in duplicate. The current


results must be printed out because they will be erased.

For single determination, the previous value is kept and a new single determination
is rerun. The PRECISION parameter defined on the first page of the test setup (see
description in chap. 5.1.1.7) is used to compare the two results.
If the difference measured between the two results is greater than the defined
difference, the STA Satellite automatically reruns a third test, compares the three
results and keeps the best pair of results.

- When returning to the TEST PANEL, the STA Satellite automatically displays the TEST
STATUS screen (see chap.10.1.3).
- Rerun of tests can also be performed as a global action (see description in chap. 8.7 ).

F4 Delete test: the test on which the cursor is positioned will be deleted.
Its status changes to deleted

Test deletion can also be performed as a global option (see description in chap. 8.7).

F5 Insert test: gives access to a selection window; move the cursor to the test you wish
to add then confirm by pressing Enter, this is only possible if the test has not already
been selected.

When returning to the TEST PANEL, the STA Satellite automatically displays the TEST
STATUS screen (see chap. 10.1.3).

F6 Print: the displayed file is printed.

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F10 Save: saves all modifications applied to the displayed file.

F11 F10 + Transmit: saves all modifications applied to the displayed file and transmits the
file.
For more details on transmission, see chap. 8.4.

F12 STAT/Normal: changes a file from non-urgent status to STAT or vice versa.

Moves the cursor.

8.3.4 Description of results in test panel

8.3.4.1 Display of tests results on single determination sample

Refer to addendum 0931969

8.3.4.2 Display rules of tests results on double determination sample

The display of the final result depends on the two gross results selected among available
results for the same test after possible reruns (up to 5 gross results).

Final gross measure- Final gross measure- Display in test panel


ment 1- Mes1 ment 2 - Mes2
OK OK If variation (Mes1,Mes2) < Tolerance :
- mean of both measurements
- each measurement plus mean in patient file
If variation (Mes1,Mes2)>Tolerance :
- alarm TOL

OK V<Vmin Err

OK V>Vmax Err

OK linearity Error Err

OK out of re-dilution If variation (Mes1,Mes2)>Tolerance :


parameters
- alarm TOL

OK Technical error Err

Technical error Technical error Err

Technical error in V<Vmin Err

Technical error V>VMax Err

Technical error linearity Error Err

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Final gross measure- Final gross measure- Display in test panel


ment 1- Mes1 ment 2 - Mes2
V<Vmin V<Vmin <Vmin with re-dilution alarm.
Gross result in chronometry: TMIN - 0.1
V<Vmin V>VMax Err

V<Vmin linearity Error Err

V>Vmax V>Vmax TMAX with re-dilution alarm.


Gross result in chronometry: TMAX + 0.1

V>Vmax linearity Error Err

linearity Error linearity Error Lin

8.3.4.3 Management of the hook effect detection

Refer to addendum 0931969

8.3.4.4 Display rules for calibration point results

 In double determination, each point is processed as a single test


 When no rerun confirmation, display of Err in the test panel
 Rerun of measurement after a technical error
 No re-dilution
No variation processing

8.3.4.5 Display rules for a calibration control

Same rule as the one applying to samples

8.3.4.6 Display rules for quality control

 Same rule as the one applying to samples

8.3.5 File processing procedure


" Access file either from the TEST PANEL or from the CONFIRMATION/PRINTOUT screen (see
chap. 8.3.1),
" Use the different keys available (see description in chap. 8.3.3 and 8.3.6 to 8.3.9).

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8.3.6 Add complementary information

Only complementary information as it is defined in the GLOBAL OPTIONS sub-menu can


be added (see chap.10.2.3.3).

2 FILE PROCESSING window is displayed.

ACTIONS RESULTS

" Highlight top test in patient file, then  The cursor moves to the first area
press the arrow key to move the cursor available for complementary information
to the "Note" area (zone 13, see (zone 13, see description in chap.
description in chap. 8.3.2) 8.3.2).

" Type the desired information then  The cursor moves to the next area
confirm using the key

" When all complementary information  The cursor moves back to the first test of
has been typed, confirm by pressing the file test list (zone 7, see description
Enter in chap. 8.3.2).

8.3.7 Add a non-standard note


2 FILE PROCESSING screen is displayed.

ACTIONS RESULTS

" Highlight last test in patient file, then  The cursor moves to the "Note" area
press the arrow key to move the cursor (zone 13, see description in chap. 8.3.2).
to the "Note" area (zone 13, see
 The following message "Optional note -
description in chap. 8.3.2)
F9 = using standard notes" is
displayed at the bottom of the screen

" Type the desired note using the  The cursor moves back to the last test of
keyboard, then confirm by pressing the file test list.
Enter

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8.3.8 Use a standard note


2 FILE PROCESSING screen is displayed, the cursor in the "Note" area (zone 13, see
description in chap.8.3.2 ) and the following message "Optional note - F9 = using
standard notes" is displayed at the bottom of the screen.

ACTIONS RESULTS

" Press F9  The standard note list is displayed.

" Move the cursor to the desired note  The standard note list is removed and
using the key then confirm by the note selected is displayed in the
pressing Enter "Note" area
(zone 13, see description in chap.
8.3.2).

" Press Enter  The cursor moves back to the last test of
the file test list.

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8.3.9 Create (or modify) standard notes


2FILE PROCESSING screen is displayed, the cursor in on the "Note" area (zone 13, see
description in chap. 8.3.2) and the following message "Optional note - F9 = using
standard notes" is displayed at the bottom of the screen.

ACTIONS RESULTS

" Press F9  The standard note list is displayed.

" Move the cursor to an empty line using  The cursor is on the desired line.
the key to create a standard note or
move it to an existing note to modify it

" Press F2, type the desired text, then  The new note (or the modified note) is
confirm by pressing Enter available in the standard note list.

" Press Esc  Return to the FILE PROCESSING screen.

8.4 Transmit results

8.4.1 Conventions
All results are transmitted according to an ASTM protocol. For more information, see the
document "User interface STA Satellite , ASTM".
All results are transmitted with two codes. The first one gives the result status (see
description in chap. 8.3.2, zone 11) and the second one, the alarm type, if necessary (see
description in chap. 8.3.2, zone 12).

8.4.2 Generalities
There are three options for transmitting results, in accordance with the conventions defined
above:
- Online transmission: the results are sent test by test as soon as they are obtained (see
description below in chap. 8.4.3).
- File by file transmission: with the F11 key from the different FILE PROCESSING screens,
access by the CONFIRMATION/PRINTOUT screen or by the TEST PANEL (see chap.8.3.3).
- File selection transmission (see description below in chap. 8.4.4).
To check transmission, see chap. 4.9.7.

8.4.3 Online transmission


When online transmission is activated, results are sent test by test as soon as they are
obtained according to the conventions described in chap. 8.4.1.

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Online transmission activation procedure:

2TEST PANEL is displayed.

ACTIONS RESULTS

" Press Esc  The Main menu is displayed:

with the cursor on Status.

" Press Enter  The Status menu is displayed:

with the cursor on System.

" Move the cursor to Online  The message Online transmission NO


transmission NO using the key, then switches to Online transmission YES.
press Enter

8.4.4 File selection transmission


This procedure allows to send all the Patient files from a given selection to the host
computer; first, a file selection must be performed (see chap. 8.2.3).

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8.4.4.1 Access the File Transmission window


This window is available in the Files menu from the CONFIRMATION/PRINTOUT screen (see
access in chap. 8.2.1).

2CONFIRMATION/PRINTOUT screen is displayed.

ACTIONS RESULTS

" Press Esc (Options)  The following window is displayed:

with the cursor on Quit.

" Press T(Transmit)  The File transmission window is


displayed (see description below).
" OR move the cursor to Transmit using
the key, then confirm by pressing
Enter

8.4.4.2 Description of the File transmission window


Fig. 5 - File transmission window

Legend:

1 Allows to choose between:

- Transmitting only files that have never been transmitted (option displayed by default)
- Transmitting all files, including files that have already been transmitted

2 Identification of the patient file currently in transmission

3 Number of Patient files to transmit left

4 List of available keys:

F10 Runs patient file transmission (or starts it again if it has been stopped)

Esc Returns to the list of selected files or stops transmission

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8.4.4.3 Run Patient file transmission


2File transmission window is displayed (see chap. 8.4.4.1).

ACTIONS RESULTS

" To include already transmitted files,  The identification of the Patient files being
press Y, then confirm by pressing F10 transmitted are displayed next to
Otherwise, press F10 Processed file (zone 2 in the File
transmission window, see description
in chap. 8.4.4.2) and the
number of Patient file to transmit left is
displayed next to Rest (zone 3, see
description in chap. 8.4.4.2).
 The messages "Transmission in
progress" and "Transmission
complete" are displayed above the
Processed File
(zone 2 in the File transmission
window, see description above in chap.
8.4.4.2).

" To stop transmission in progress, press  The following message "Trans.


Esc interrupted" is displayed above
Processed file (zone 2 in the File
transmission window, see description
above in chap. 8.4.4.2).
 The F10 key restarts transmission.
 The Esc key returns to the list of
selected files.

" When transmission is finished, press  Return to the selected file list.
Esc
 The letter T is displayed in front of the
identification of each file actually
transmitted.

8.5 Patient file printout

8.5.1 Generalities
There are three file printout options:
ˆ Online printout: Patient files are printed file by file as soon as they are complete (see
description in chap. 8.5.8).
ˆ Printout of an individual file: by pressing F6:
- Directly from the CONFIRMATION/PRINTOUT screen for the file on which the cursor is
positioned (see chap. 8.2.2),

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- Or from the FILE PROCESSING screens accessible either from the CONFIRMATION/PRINTOUT
screen, or from the TEST PANEL (see chap. 8.3.3).
ˆ Printout of a file selection: (see chap. 8.5.9).
In any case, printout parameters are set from the Printout window accessible as soon as
the Print option is selected (see below in chap. 8.5.4 to 8.5.7). This option is only available
for an external printer.
To check the printer parameters or its connection, see chap. 4.9.4.
In addition, Patient file printout from the external printer can also be custom-built (see chap.
8.8).

8.5.2 Printer selection


The Patient file can be either printed:
- on the internal printer,
- on the external printer.

If the operator decides to print files with the external printer, printout parameters must be
checked (see chap. 8.5.5 to 8.5.10).

2TEST PANEL is displayed.

ACTIONS RESULTS

" Press Esc  The Main menu is displayed:

with the cursor on Status.

" Press S (Setup)  The following sub-menu is displayed:


" or press the key to move the cursor
to Setup, then confirm by pressing
Enter

with the cursor on Tests.

" Press G (Global Options)  The following window is displayed:


" OR press the key to move the cursor
to Global Options, then confirm by
pressing Enter

" Identify yourself (see chap. 4.9.13.5).  The first GLOBAL OPTIONS screen is
displayed (see description below in
chap. 10.2.2.1).

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ACTIONS RESULTS

" Press the key to access page 2 of the  The page 2 of the GLOBAL OPTIONS
GLOBAL OPTIONS window screen is displayed.

" Press the key to acces the Printer tab  The Exit Option screen is displayed:
" Then, in the Printer printout field, use
Del to select:
- the internal printer,
- or the external printer.

" Press Esc


with the cursor on Save before quitting.

" Press Enter to confirm  The STA Satellite operates global


check.
 Return to the CHECK DONE screen.

If Patient files are printed on the internal printer, there is no printout setup to define (see
printout examples in chapter below).

8.5.3 Printout examples (internal printer)


Fig. 6 - Patient file printout on the internal printer

Legend:

1 Name of the laboratory, as defined in the Global Options menu (see chap. 10.2.2.2).

2 Date and time of printout.

3 Patient file identification.

4 Complete test name, preceded by an asterisk (*) if the test has one or several alarms.

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5 Result in primary unit.

6 Result status:

- Blocked,
- Waiting,
- In progress,
- To be validated,
- Error (for the following results:
Technical error, measurement > V max., measurement < V min., Dev.> linearity Tol,
quantity of plasma not sufficient),
- Validated.

7 Usual values for each test as defined in the setup screens (see chap. 5.1.3.2).

Fig. 7 - Daily control menu printout of the internal printer

Legend:

1 Screen name.

2 Test abbreviations.

3 Control names.

4 Time when controls were run.

5 Results obtained for the quality control.

6 Recall of the acceptance range for the quality control.

7 Result status:

- Validated,
- Forced,
- Out Range,
- In progress,
- Error.

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8.5.4 Access Printout window


This window is accessible in the File menu from the CONFIRMATION/PRINTOUT screen (see
acess in chap. 8.2.1).
The window allows to define the printout parameters if the operator decides to print Patient
files on the external printer.

2CONFIRMATION/PRINTOUT screen displayed.

ACTIONS RESULTS

" Press Esc (Options)  The following window is displayed:

with the cursor on Quit.

" Press P (Print)  The Printout window is displayed (see


" OR move the cursor to the Print zone description below).
by pressing the key, then confirm by
pressing Enter

8.5.5 Description of the printout window


Fig. 8 - Printout window

Legend:

1 Prints only the unprinted files from a Patient file selection (see procedure in chap.
8.5.9).

2 Print all files from a selection (see chap. 8.5.9).

3 Define printout parameters for the external printer (see procedure in chap. 8.5.6 and
8.5.7).

4 Return to the selected file list or stops printout in progress.

5 Printout parameters of the external printer.

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8.5.6 Description of the printout parameters for the external printer


If the operator decides to print files on the external printer, three parameters define printout
(zone 5 on the printout window) :
ˆ Mode: all files or single file.
- All files mode: the laboratory name is printed at the top of each page, which length
depends on the Page length parameter; Patient files are printed one by one, like a table.
- Single file mode: for each file, the laboratory name is printed.
The page change occurs according to the Page length parameter.

ˆ Quality: Standard quality or presentation quality.


- Standard quality: allows fast printout that does not print some special character
configuration.
- Presentation quality: allows a better quality printout (character configuration,...), but, as
a consequence, slower.

ˆ Page length: Defined in number of lines.


- Page length: defines the Patient file length (single file mode) or the length of a patient
file table (all files mode), without taking into account the actual length of the paper.

To avoid frequent cuts in files, apply the following principle:


- 1 inch = 6 lines
- 11 inch paper => 66 lines in a real page

For example:
- To print 2 Patient files per page, set Page length = 33 lines
- To print 3 Patient files per page, set Page length = 22 lines

To avoid frequent cuts in files, apply the following principle:


• 1 inch = 6 lines
• 11 inch paper => 66 lines in a real page
• To print 2 Patient files per page, set Page length = 33 lines
• To print 3 Patient files per page, set Page length = 22 lines

When a Patient file is cut:


• The following message "Continued: next page " is printed at the lower right corner of
the first part.
• The complete Patient file identification (including complementary information) is
reminded at the top of the second part.

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• The message "Continued" is printed above the Patient file identification for the second
part.

The laboratory name is defined in the Global Options menu (see chap. 10.2.2.2).

8.5.7 Define printout parameters


If the operator decides to print the Patient file on the external printer, the printout parameters
described in chapter 8.5.6. must be defined.

2The Printout window is displayed with the cursor on (see chap. 8.5.4).

ACTIONS RESULTS

" Press P (Printer setup).  The following window is displayed:


" OR Move the cursor to Printer setup by
pressing the key, then confirm by
pressing
Enter

with the cursor on all files or single file.

" To modify a given parameter: move the  For the Mode parameter, definition
cursor to the parameter using the key, changes from all files to single file or
then change it by pressing Enter vice versa
 For the Quality parameter, definition
changes from normal to optimal or vice
versa.
 For the Page Length parameter, the
cursor moves to the line number (see
description of the printout parameters in
chap. 8.5.6).

" Type the number of desired lines on the  Parameters are displayed.
keyboard, then confirm by pressing
Enter

" When all parameters are set, press Esc  Return to Printout window.

8.5.8 Online printout


When online printout is activated, the Patient files are printed as soon as:
- all the tests of the file have been completed
- the file status is "confirmed"

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Printout is performed according to the parameters defined (for the external printer) in the
Printout window (see description in chap. 8.5.4 to 8.5.9 and chap. 8.5.7.).

Procedure to activate the online printout:

2TEST PANEL displayed.

ACTIONS RESULTS

" Press Esc  The Main menu is displayed:

with the cursor on Status.

" Press Enter  The Status menu is displayed:

with the cursor on System.

" Move the cursor to Online printout NO  The option Online printout NO changes
using the key, then confirm by to Online printout YES.
pressing
Enter

8.5.9 Patient file selection printout

If online printout has been selected, this option is available only if the STA Satellite is in
stand-by mode (no measurement in progress) and if all printouts previously scheduled
have been processed. If the online printout has not been selected, this option is always
available.

This procedure allows to print all files from a given selection; first it is necessary to select
Patient files (see chap. 8.2.3).

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2The Printout window is displayed (see procedure in chap. 8.5.4) with the cursor on
.

ACTIONS RESULTS

" Change printout parameters if  A window is displayed on the top left


necessary (see chap. 8.5.6 and 8.5.7). corner. The window shows the
identification of the file being processed
" Depending on the Patient files wanted:
and the number of files left to print.
- All file that have not been printed yet:
 At the same time, printout of the selected
press the key (Unprinted Files) then
files starts.
confirm by pressing Enter
- All selected files: press the key until
you reach All files then confirm by
pressing Enter

" To stop printout in progress, press A  The files already processed continue
being printed.
 Then, printout stops.

" When all files have been printed:  Automatic return to the selected file list.
 The letter P is displayed in front of the
identification of each file actually printed.

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8.5.10 Printout examples on the external printer


Fig. 9 - Patient file printout, Single file, optimal quality mode

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Fig. 10 - Patient file on-line printout, All file, normal quality mode
(on external printer)

Legend:

1 Name of the laboratory, as defined in the Global Options menu (see chap. 10.2.2.2).

2 Date and time of printout.

3 File identification including complementary information (last name, first name, etc.) if it
is used. On the second line, the standard note is displayed, if it is used.

4 Complete test name, preceded by an asterisk (*) if the test has one or several alarms.

5 Result in the primary unit

6 Result in the first secondary unit, if it is used

7 Result in the second secondary unit, if it is used

8 Result in the third secondary unit, if it is used

Note: zones 5, 6, 7 and 8 are empty if the result cannot be confirmed.

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9 Result status:

- Blocked,
- Waiting,
- In progress,
- To be confirmed,
- Error (for the following results:
Technical error, measurement > V max., measurement < V min., Dev.> linearity Tol,
quantity of plasma not sufficient),
- Validated.

10 Usual values for each test as defined in the setup screens (see chap. 5.1.3.2).

11 List of alarms presented by test (see definition point 12 of chap. 8.3.2).

12 Page number. In "Single file" mode, the page number starts at 1 for each file.

8.6 Deleting patient files from the Working File

This option is available only if the STA Satellite is on stand-by mode (no measurement
in progress) and if the printouts previously scheduled have been processed.

When the Working File is full (more than 600 files), the operator is requested to delete the
oldest file which sample tube has been removed.

The Patient files deleted through this procedure are lost.

The option Delete file from the Working File is also available when switching the STA
Satellite on (see procedure in chap. 3.2.1).
But in this case, no file selection is available.

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8.6.1 Access the file deletion window


2TEST PANEL is displayed.

ACTIONS RESULTS

" Press Esc  The Main menu is displayed:

with the cursor on Status.

" Press F (File)  The following Files menu is displayed:

With the cursor on Confirmation/


Printout/Transmission.

" Press D (Delete Patient file)  The File deletion window is displayed
(see description below in chap. 8.6.2).
" OR move the cursor to Delete Patient
file using the key, then confirm by
pressing
Enter

8.6.2 Description of the file deletion window


Fig. 11 - File deletion window

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Legend:

1 Identification of the first file of the selection

2 Identification of the last file of the selection

3 Prefix identification

4 Category of the selected files identified by a colored square:


Blue: Confirmed files (YES/NO),

White: Complete files (YES/NO),

Red: Complete files with errors (YES/NO),

Yellow: Incomplete files (YES/NO).

By default, all the options are set to YES (colored square displayed).

5 List of available keys:


F3 Selects files with the cursor within the available test list,

F4 Deletes the entire Working File,

F10 Displays the list of selected files, and allows its deletion,

Moves the cursor to different parameters,

Esc Return to TEST PANEL.

6 List of selectable files (selection procedure in progress) or selected (selection


procedure done).

8.6.3 Deletion procedure of Patient files from the Working File


2File deletion window is displayed (see chap. 8.6.1).
ACTIONS RESULTS

" Press F3  The message "Please select the first


file" is displayed.
 All available patient files from the
Working File are displayed in zone 6,
see description of the File deletion
window in chap. 8.6.2.

" Use the cursor motion keys to move it to  The message "Please select the last
the desired file, then confirm by file" is displayed.
pressing Enter
 Identification of the first file selected is
recalled.

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ACTIONS RESULTS

" Use the cursor motion keys to move it to  The File deletion window is displayed
the desired file, then confirm by with the cursor on the Prefix field
pressing Enter (zone 3 ).
Identifications of the first and last file
selected are displayed in zones 1 and 2
(see description of the File deletion
window in chap. 8.6.2).

" Type the prefix identification, then  The prefix identification is displayed in
confirm by pressing Enter zone 3 and the cursor is on zone 4 (see
" OR type the first digit(s) or letter(s) of description of the File deletion window
the desired Patient file identifications, in chap. 8.6.2).
then confirm by pressing Enter
" OR leave the area blank (no prefix
definition), then confirm by pressing
Enter

" When a category of file must not be  The colored square is removed.
deleted, use the key to move the
cursor to the file, then, confirm by
pressing Enter to remove the colored
square.

" When all selection parameters are set,  The list of selected files is displayed in
press F10 zone 6 (see description of the File
deletion window in chap.8.6.2).
 The following message "Please type
YES to confirm deletion" is displayed.

" Type YES, then confirm by pressing  The files are removed from zone 6 (see
Enter description of the File deletion window
in chap. 8.6.2).

" Press Esc.  Return to TEST PANEL.

8.6.4 Deletion procedure of the entire Working File


2File deletion window is displayed (see chap. 8.6.1).

ACTIONS RESULTS

" Press F4  All available patient files from the


Working File are displayed in zone 6,
see description of the File deletion
window in chap.8.6.2.
 The following message "Please type
YES to confirm deletion" is displayed.

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ACTIONS RESULTS

" Type YES, then, confirm by pressing  All files from the Working File are
Enter removed from zone 6 (see description of
the File deletion window in chap. 8.6.2).

" Press Esc  Return to TEST PANEL.

8.7 General file modification


This menu allows to block or unblock tests, to rerun or delete tests from a given selection.

8.7.1 Access the FILE MODIFICATION screen


2TEST PANEL is displayed.

ACTIONS RESULTS

" Press F9  The following window is displayed:

with the cursor on .

" Press F (File modification)  The FILE MODIFICATION screen is


" OR move the cursor to File displayed
modification using the key, then (see description in chap. 8.7.2).
confirm by pressing Enter.

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8.7.2 Description of the FILE MODIFICATION screen


Fig. 12 - FILE MODIFICATION screen

Legend:

1 F1 Change: opens a window which allows to choose the type of file modification to
apply:

Block: Blocks the pending tests.


Unblock: Unblocks blocked tests.
Rerun: Reruns tests for selected files.
Delete: Delete tests for selected files.

Note: There is only one type of modification possible at a time.

2 Identification of the type of modification chosen. The first letter of the name of the
modification is displayed in yellow

3 F2 Selects the Patient file on which the file modification will be applied (see procedure
in chap. 8.7.4).
This function is not available when the file modifications selected are Block or Unblock

4 Identification of the first file selected

5 Identification of the last file selected

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6 List of available keys:

Applies file modification chosen (or cancels it) for the test on which the cursor is
positioned

F10 Executes the file modification chosen

Esc Returns to TEST PANEL

7 Complete name of the test on which the cursor is positioned

8 Abbreviation list of available tests. The letter B (Blocked) is displayed in grey on the
left of the tests currently blocked. When selecting the tests the file modification will be
applied to, a letter is displayed in yellow on the left of the related tests:
B to Block,
U to Unblock,
R to Rerun,
D to Delete.

Note: The following message "Sample pipetting blocked" is displayed in white on a red
background at the bottom of the screen when sample pipetting is blocked either:
- intentionally by the operator (Stop Sample Pipetting function, see description in
chap. 10.1.5.1),
- or automatically by the STA Satellite if the requested tests cannot be performed.

8.7.3 Block or unblock tests

The Block or Unblock options concern tests from all Patient files present in the Working
File and the quality controls automatic (periodic) running. But these options do not concern
calibrations, nor calibration controls. As a consequence, file selection is not available.
The Block option is only available for pending tests and Unblock is only available for
blocked tests.
However, the operator can force the quality control running for a blocked test by using the
Run function from the Quality control menu (see chap. 9.3).
After tests have been unblocked, when returning to the TEST PANEL, the STA Satellite
automatically displays the TEST STATUS screen (see description in chap. 10.1.3).

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2FILE MODIFICATION screen is displayed (see procedure in chap. 8.7.1).

ACTIONS RESULTS

" Press F1  The following window is displayed:

with the cursor on Block.

" To block, press Enter  Block is displayed in the Action


" To unblock, press U (Unblock) or area (zone 2, see description of the FILE
MODIFICATION screen in chap. 8.7.2).
move the cursor to Unblock using the
key, then confirm by pressing Enter  Unblock is displayed in the Action area
(zone 2, see description of the FILE
MODIFICATION screen in chap. 8.7.2).

 The cursor is on the first test in zone 8


(see description of the FILE
MODIFICATION screen in chap. 8.7.2).

" Use the arrow keys to move it to each  A letter is displayed in yellow on the left
related test and select each test by of each marked test: B for Block,
pressing Enter U for Unblock.

" Press F10  The file modification is applied.


 For the Block function, the TEST PANEL is
displayed:
- The message Block is displayed in red
instead of the results for all tests
concerned by the Block option,
 For the Unblock function, the TEST
STATUS screen is displayed (see
description in chap. 10.1.3).

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8.7.4 Rerun or delete tests

In case of duplicate determination, the result is rerun in duplicate. The current results
must be printed out because they will be erased.
For single determination, the previous value is kept and a new single determination is
run. The PRECISION parameter defined on the first page of the test setup (see description
in chap. 5.1.1.7) is used to compare the two results.
If the difference measured is greater than the defined difference, the STA Satellite
automatically runs a third test, compares the three results and keeps the best pair of
results

After rerunning tests, when returning to the TEST PANEL, the STA Satellite automatically
displays the TEST STATUS screen (see description in chap. 10.1.3).

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2FILE MODIFICATION screen is displayed (see procedure in chap. 8.7.1).

ACTIONS RESULTS

" Press F1  The following window is displayed:

with the cursor on Block.

" To rerun tests, press R (Rerun) or  Rerun is displayed in the Action area
move the cursor to Rerun using the (zone 2, see description in chap. 8.7.2 ).
key, then confirm by pressing Enter
 Delete is displayed in the Action area
" To delete tests, press D (Delete) or (zone 2, see description in chap. 8.7.2 ).
move the cursor to Delete using the
key, then confirm by pressing Enter

" Press F2  The TEST PANEL is displayed.


 The following message "Please select
the first file" is displayed.

" Use the arrow keys to move it to  The message "Please select the last
the desired file, then confirm by file" is displayed.
pressing Enter
 The identification of the first file selected
is recalled.

" Use the arrow keys to move it to the  The FILE MODIFICATION screen is
desired file, then confirm by pressing displayed again with the cursor on the
Enter first test in the available test list (zone 8)
and the identifications of the first and the
last test selected displayed in zone 4
and 5 (see description of the FILE
MODIFICATION screen in chap. 8.7.2).

" Use the arrow keys to move it to each  A letter is displayed in yellow on the left
test concerned, then select each test by of each selected test: R for Rerun,
pressing Enter D for Delete.

" Press F10.  The file modification is applied.


 For the Rerun function, the TEST STATUS
screen is displayed (see description in
chap. 10.1.3).
 For the Delete function, the TEST PANEL
is displayed, results are removed (empty
box) (see description of the TEST PANEL,
in chap. 3.3.1).

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8.8 Customer file printout on the external printer

8.8.1 Generalities
The customer printout is only available if the operator decides to print files on the
external printer.
This menu allows to print Patient files according to the particular need of each laboratory.
The files concerned by the customer printout are all the confirmed Patient files present in
the Working File.

A confirmed file is a file for which all tests are done and confirmed

The location and the type of information related to the Patient files (Patient identification, test
names, results) cannot be modified; only headings or additional remarks are defined by
each laboratory.
Only one file is printed on each page.

Through this menu, results are printed without alarm messages. A major part of the
information is missing. Diagnostica Stago denies all liablility for the use of this menu.

For customer printout of the Patient files, you must:


" Setup printout parameters (see chap. 8.8.4)
" Select files to be printed (see chap. 8.8.5)
" Then run printouts (see chap. 8.8.6)

8.8.2 Access the CUSTOMER PRINTOUT OF CONFIRMED FILES window


(Option available on the external printer only)

This procedure is only available if:


- the STA Satellite is in stand-by mode (no measurement in progress),
- the operator has chosen to print Patient file on the external printer.

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2TEST PANEL is displayed.

ACTIONS RESULTS

" Press Esc  The Main menu is displayed:

with the cursor on Status.

" Press F(Files)  The following Files menu is displayed:

With the cursor on Confirmation/


Printout/Transmission.

" Press C (Customer printout)  The CUSTOMER PRINTOUT OF CONFIRMED


FILES is displayed (see description in
" OR move the cursor to Customer
printout using the key, then confirm chap. 8.8.3).
by pressing Enter

8.8.3 Description of the CUSTOMER PRINTOUT OF CONFIRMED FILES screen


Fig. 13 - CUSTOMER PRINTOUT OF CONFIRMED FILES screen

Legend:

1 List of available keys:

F6 Prints Patient file on which the cursor is positioned

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Esc Options, this key displays the following window:

Change file selection: selects a group of Patient files with a filtering prefix (see
description in chap. 8.8.5)
Print unprinted files: prints only files that have not been printed from a selection of
Patient files (see procedure in chap. 8.8.6)
Print all files: prints all selected files (see procedure in chap. 8.8.6)
Printout configuration: defines printout parameters (see description in chap. 8.8.4)
Quit: returns to TEST PANEL

2 Complementary information (last name, first name... , see description in chap. 10.2.3.3)
for the file on which the cursor is positioned.

3 List of selected files. The letter P shows that the file has already been printed through
the CUSTOMER PRINTOUT OF CONFIRMED FILES window.

4 Warning message.

8.8.4 Setup customer printout

Customer printout setup is only available if the operator decides to print files on the external
printer.

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8.8.4.1 Customer printout format


Fig. 14 - Customer printout format

To determine the length of the Patient file, the Customer printout menu uses the Page
T
o

length parameter defined in the Files menu (Printout window, CONFIRMATION/PRINTOUT


screen) on condition that this parameter is greater than 54 (see chap. 8.5)

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Legend:

1 Information defined by the laboratory (titles, headings, notes, ...). For the definition of
information, see chap. 8.8.4.3 and 8.8.4.4.

2 Patient file identification (16 characters maximum), field n°1 as defined in the Global
Options menu (see chap. 10.2.3.3).

3 Content of fields n°2 and n°3 as defined in the Global Options menu:
16 characters and 12 characters maximum (see chap. 10.2.3.3).
The content of field n°2 is printed in upper-case letters. The first letter of the content of
field n°3 is printed in upper-case letters, the rest in lower-case letters.

4 Content of field n°4 as defined in the Global Options menu: 6 characters maximum
(see chap. 10.2.3.3).

5 Content of field n°5 as defined in the Global Options menu: 4 characters maximum
(see chap. 10.2.3.3).

6 Date of printout. The format used is the one defined in the Global Options menu (see
chap. 10.2.3.4).

7 Complete test name as defined in the Test Setup menu (see chap. 5.1.1.1).
The result table can contain an entire Patient file i.e.: 12 tests.

8 Result in the primary unit.

9 Result in the first secondary unit.

10 Result in the second secondary unit.

11 Result in the third secondary unit.

Note: results for the secondary unit may be printed only if YES had been selected for
printout in the TEST SETUP screens (see chap. 5.1.3.2).
Fields 8, 9, 10 and 11 can be replaced by the following message «Out of range» when the
result was confirmed even though its status was «Time>T max» (see chap. 8.3.3).

12 Usual values for each test as defined in the TEST SETUP screens (see chap. 5.1.3.2).

13 Standard note as defined in the FILE PROCESSING screens (see chap. 8.3.7 to 8.3.9).

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8.8.4.2 Access PRINTOUT SETUP screens


2CUSTOMER PRINTOUT OF CONFIRMED FILES window is displayed (see chap. 8.8.2).

ACTIONS RESULTS

" Press Esc  The sub-menu is displayed:

with the cursor on Quit.

" Press the key (Printout  The first PRINTOUT SETUP screen is
Configuration), displayed (see description below in
then confirm by pressing Enter chap. 8.8.4.3).

8.8.4.3 First PRINTOUT SETUP screen (Customer printout menu)


Fig. 15 - PRINTOUT SETUP screen, page 1 of 2

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For the customer printout format, see chap. 8.8.4.1.

Legend:

1 List of available keys:

Esc Returns to the CUSTOMER PRINTOUT OF CONFIRMED FILES screen

Displays the second PRINTOUT SETUP screen

Moves the cursor to the next line ( key) or to the previous line ( key)

F10 Saves the printout setup parameters

2 Definition of the 2 main titles:


2 lines of 48 characters.
If one of the 2 titles contains more than 35 characters, then the 2 main titles are printed
in enlarged bold condensed format, otherwise ( 35), they are printed in enlarged bold format.

Note: The first title must be entered.


3 Definition of the 4 secondary titles:
4 lines of 60 characters printed in normal characters. The non-defined titles are printed
as blank lines.

4 Definition of 5 general data names:


5 lines of 25 characters printed in normal characters. The general data names must be
defined according to their respective content (see description in chap. 8.8.4.1).

Note: General data name n°1, n°2 and n°5 must be entered.

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8.8.4.4 Second PRINTOUT SETUP screen (Customer printout menu)


Fig. 16 - PRINTOUT SETUP screen, page 2 of 2

For the customer printout format, see chap. 8.8.4.1.

Legend:

1 List of available keys:

Esc Returns to the CUSTOMER PRINTOUT OF CONFIRMED FILES screen

Displays the first PRINTOUT SETUP screen

Moves the cursor to the next line ( key) or to the previous line ( key)

F10 Saves the printout setup parameters

2 Definition of the titles for the result table:


3 lines of 16 characters printed in condensed bold format.
These titles must be defined according to the respective content of each column (see
chap. 8.8.4.1).

Note: The 3 titles for these results must be entered.

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3 Constant remark:
2 lines of 60 characters printed on one line in a condensed format.

4 Definition of the title for the optional note name:


1 line of 16 characters.
(See definition of the optional note name point 13 of chap. 8.8.4.1).

5 Definition of the 2 final titles:


2 lines of 40 characters printed in bold, enlarged, condensed format.

8.8.4.5 Modification of the customer printout definition parameters


2PRINTOUT SETUP screen is displayed, see access in chap. 8.8.4.2.

ACTIONS RESULTS

" Move the cursor to the desired  The cursor is on the desired parameter.
parameter using the key

" Type the new information on the  The new information is displayed.
alphanumerical keyboard then confirm
 The cursor moves to the next parameter.
by pressing Enter

" When all information is entered, press  Customer printout definition parameters
F10 are saved.
 Return to the CUSTOMER PRINTOUT OF
CONFIRMED FILES screen.

8.8.5 File selection for customer printout

8.8.5.1 Access the File selection window (customer printout)


2CUSTOMER PRINTOUT OF CONFIRMED FILES screen is displayed (see chap. 8.8.2)

ACTIONS RESULTS

" Press Esc  The following sub-menu is displayed:

with the cursor on Quit.

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ACTIONS RESULTS

" Press C (Change file selection)  The File selection window is displayed
(see description in chap. 8.8.5.2).
" OR move the cursor to Change file
selection using the key then confirm
by pressing Enter

8.8.5.2 Description of the file selection window (customer printout)


Fig. 17 - File selection window (customer printout)

Legend:

1 Identification of the first file of the selection

2 Identification of the last file of the selection

3 List of available keys:

F1 Displays "beginning of list", corresponding to the first file among the test list in
chronological order of all confirmed files available in the Working File

F2 Displays "end of list", corresponding to the last file among the test list in
chronological order of all confirmed files available in the Working File

F3 Selects files with the cursor within the available test list

F10 Operates predefined selection and displays it

Esc Returns to the CUSTOMER PRINTOUT OF CONFIRMED FILES screen

Moves the cursor to the different parameters.

4 Filtering prefix identification

5 Category of the selected files identified by a colored square:


Blue: Confirmed files (YES/NO),

White: Complete files (YES/NO),

Red: Complete files with errors (YES/NO),

Yellow: Incomplete files (YES/NO).

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8.8.5.3 Change selection (customer printout)


2File selection window displayed on the CUSTOMER PRINTOUT OF CONFIRMED FILES screen
(see chap. 8.8.5.1).

8.8.6 File selection printout (customer printout)


2CUSTOMER PRINTOUT OF CONFIRMED FILES displayed (see access in chap. 8.8.2).
*

ACTIONS RESULTS

" Press Esc The following sub-menu is displayed:

with the cursor on Quit.

" Depending on the files requested:  A window is displayed on the top left
corner. The window shows the
- all files not yet printed: move the cursor
identification of the file being processed
to Print unprinted files using the key
and the number of files left to print.
then confirm by pressing Enter
 Printout of the selected files starts
- all files selected: move the cursor to
simultaneously.
Print all files using the key, then
confirm by pressing Enter

" To stop printout in progress, press Esc  The files already processed continue
being printed.
 Then, printout stops.

" When all files have been printed:  Automatic return to the selected file list.
 The letter P is displayed in front of the
identification of each file actually printed.

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8.9 Working list download


Purpose: To request again to the host computer the working list for all tubes already loaded
which have not received it during sample loading. Indeed, if the Patient file identification is
not known by the host computer when loading the tube, the STA Satellite request receives
no response.
Without this function, the only way to perform the work list request again is to unload the
tubes ,and to load them again one by one.

2TEST PANEL displayed.

ACTIONS RESULTS

" Press F11  The following window is displayed:


Downloading
File: xxxxx
Esc = Cancel
xxxxx = identification of the Patient file
being downloaded.
The Patient file work lists are received.

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Table of Contents

9 Quality Control ........................................... 1

9.1 Generalities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

9.2 Access quality control results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2

9.3 Description of the quality control screens . . . . . . . . . . . . . . . . . . . . . 3


9.3.1 Description of the QUALITY CONTROL screen (test list) . . . . . . . . . . . . . . . . 3
9.3.2 Description of the quality control result screen (graphic mode) . . . . . . . . . . 4
9.3.3 Description of the quality control result screen (tabular mode) . . . . . . . . . . 7

9.4 Procedure to run and confirm quality controls . . . . . . . . . . . . . . . . . 9


9.4.1 General principles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
9.4.2 Quality controls loading . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
9.4.3 Change range values for quality controls . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
9.4.4 One level quality control run . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
9.4.5 Quality control simplified run . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

9.5 Procedures to observe for out of range quality controls . . . . . . . 15


9.5.1 Message and alarm code displayed for out of range controls . . . . . . . . . . . 15
9.5.2 Description of the OUT OF RANGE CONTROL window . . . . . . . . . . . . . . . . 15
9.5.2.1 Accept out of range quality controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
9.5.2.2 Rerun out of range quality controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17

9.6 Other available operations on quality controls . . . . . . . . . . . . . . . . 18


9.6.1 Cancelation of a control run . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
9.6.2 Delete controls of the day . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
9.6.3 Delete all quality control results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
9.6.4 Print quality control results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
9.6.4.1 Print quality control results as a graph . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
9.6.4.2 Print quality control results as a table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22

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9.6.5 Transmit quality control of the day . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23


9.7.1 Description of the CONTROL OF THE DAY screen . . . . . . . . . . . . . . . . . . . . 24

9.7 Controls of the day . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24


9.7.2 Access to the controls of the day . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25

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9 Quality Control
9.1 Generalities
For each test, at least one quality control must be run daily if at least one patient result is
requested for the test.
Up to three quality control can be defined for each test, within the TEST SETUP screens (see
chap. 5.1.3.4).
Quality controls vials are loaded into the product carousel and are run automatically by the
STA Satellite® (see details in chap. 9.4).
In the QUALITY CONTROL sub-menu, quality control results are processed on 3 zones:
- Controls of the day zone
- Sums daily zone
- Sums monthly zone
(See description of these zones in chap. 9.3.2 and 9.3.3).

In these zones, up to 2 lot numbers can be stored.

When controls from a new lot are loaded, values of the old lot are automatically deleted, the
previous lot becomes the old lot and the new lot becomes the current lot.

The processing of the quality controls is based on the Levy-Jennings model:

i=n

∑ xi
Mean: i=1 -
m = ------------- xi = result in primary unit
n

Standard deviation:

Coefficient of variation:

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n varies depending on the 3 processing zones:

Zone n

Control of the day 1 to 24

Sums Daily 1 to 31

Sums Monthly 1 to 12

9.2 Access quality control results


2TEST PANEL is displayed.

ACTIONS RESULTS

" Press Esc  The Main menu is displayed:

" Press C (Calib./Control)  The following sub-menu is displayed:

" Move the cursor to Quality control  The QUALITY CONTROL screen is
using the key, then press Enter to displayed (see description in
confirm chap. 9.3.1).
 The cursor is on the first test of the list.

" Press the or keys to move the  Results of the quality control for the first
cursor to the desired test, then confirm control are displayed in graphic form
by pressing Enter (see description in chap. 9.3.2).

" Press F3  Results of quality controls for the next


control are displayed in graphic form
Note: If only one level of quality control
(see description in chap. 9.3.2).
has been defined with F3, the same
level is displayed.
For 2 or 3 levels, F3 allows to loop the
different levels.

" Press F2  Return to results of the previous control


displayed in graphic mode (see
description in chap. 9.3.2).

" Press F1  Results of quality control for the control


in progress displayed in tabular mode
(see description in chap. 9.3.3).

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ACTIONS RESULTS

" From the quality control result screen in  Return to QUALITY CONTROL screen (test
graphic form, press Esc, then confirm list).
by pressing Enter

" Press Esc  Return to TEST PANEL.

9.3 Description of the quality control screens

9.3.1 Description of the QUALITY CONTROL screen (test list)


Fig. 1 - QUALITY CONTROL screen (test list)

Legend:

1 List of available keys:

Displays results of the quality controls for the selected test.


F1 Running request: requests running of all quality control levels for the test on which
the cursor is positioned.
F10 Execute running: runs quality controls requested by the F1option (see simplified run
procedure in chap. 9.4.5).
Esc Returns to TEST PANEL.

2 Name of the screen.

3 List of the test abbreviations with a colored square of the abbreviation showing the
quality control status (see point 5 below).

4 Complete name of the test on which the cursor is positioned.

5 List of the color codes that allows to identify the status of each quality control:

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White:Confirmed.
Blue:To be confirmed.
Yellow:Running.
Red: Not done.

9.3.2 Description of the quality control result screen (graphic mode)


Fig. 2 - Quality control result screen (graphic mode)

Legend:

1 List of available keys:

F1 displays results in tabular mode.


F2/F3 give access to the previous/next level; results are always displayed in graphic mode.
Esc Options, displays the following window:

Print: prints the GRAPHIC screen.

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Run: runs quality control for the level displayed.


cancels quality control ("in progress" status) for the level displayed.
Change range: changes the result acceptance range.
Delete all results: deletes all values displayed on the screen.
Return to result list: returns to the QUALITY CONTROL screen (Test list).

When an option is not available, its name is displayed in grey (otherwise, it is displayed in
blue).

2 Level indication: 1, 2 or 3.

3 Complete name of the test.

4 Primary unit of results.

5 Identification number of the control plasma.

6 Complete name of the control plasma.

7 Current lot number of the control plasma.

8 Sums daily: displays zone of the 31 last means of daily controls.

These values do not necessarily correspond to consecutive days, they may also
correspond to several different months. The day corresponding to each mean is
displayed at the bottom of the SUMS DAILY zone.

A new point can be added on the right of the existing points, shifting the points of one
position to the left when there are more than 31 points. In this case, the display of the
first point is lost.

The means of the daily controls are displayed according to the following color codes:

+++ (green): Daily control means obtained during the previous months and which
are within the result acceptance range.

+++ (red): Daily control means obtained during the previous months and which
are outside the result acceptance range.

xxx (yellow): Daily control means for the current month and which are within the
result acceptance range.

xxx(red): Daily control means for the current month and which are
outside the result acceptance range.

(red): Out of scale result.

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When the result acceptance range is changed by the operator, colors of the various points
are updated according to the new range (see chap. 9.4.3).

9 Controls of the day: display zone of the quality control results for a 24-hour period.
From day change and as soon as a quality control is confirmed (automatically or
manually), this zone is automatically emptied and the point corresponding to the mean
of the last 24-hour period is displayed in the SUMS DAILY zone.

In the CONTROLS OF THE DAY zone, points can be added on the right of existing points.
Depending on the situation, results are displayed with various color codes:
o (blue): Result within the quality control acceptance range.
o (red): Result outside the quality control acceptance range.
(red): Out of scale result.
10 Green vertical bar indicating a lot change for the quality control (up to 2 sets can be
processed).

11 Acceptance range for the quality control results; represented by white dotted lines
displayed in the 3 following zones:
CONTROLS OF THE DAY, SUMS DAILY and SUMS MONTHLY.

12 Mean of the acceptance range for the quality control results, represented by white solid
line which is displayed in the 3 zones:
CONTROLS OF THE DAY, SUMS DAILY and SUMS MONTHLY.

13 Mean ± 2 σ (σ = Standard deviation) of the quality control results of the SUMS DAILY zone,
it is represented by yellow dotted lines.

14 Mean of the quality control results of the SUMS DAILY zone, represented by a solid yellow
line.

15 Glossary explaining the meaning of the color codes displayed on the screen.

16 Sums monthly: display zone of monthly means of the quality control results. For each
calendar month, the mean ± 2 σ is represented by a yellow line, mean + 2 σ and mean
- 2 σ by yellow dotted lines. Out of scale values are displayed with red ∆. The month
number is displayed at the bottom of the Sums Monthly zone.

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9.3.3 Description of the quality control result screen (tabular mode)


Fig. 3 - Quality control result screen (tabular mode)

Legend:

1 Available funtions:

Esc Back to graph: returns to graphic display of the quality control results for the level
displayed.
F4 Delete daily controls: deletes one or several results from the control of the day.
F6 Print: prints out results in tabular mode.
F11 Transmit daily controls: transmits controls of the day to the host computer.
2 Level indication: 1, 2 or 3.

3 Complete name of the test.

4 Primary unit of results.

5 Identification number of the control plasma.

6 Complete name of the control plasma.

7 Current lot number of the control plasma.

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CONTROL OF THE DAY zone:


8 Display zone of the results of the quality control of the day.

The following indications are displayed:


- the result in primary unit (Res.),
- the time when the quality control was run (Time).

The indications are displayed:


- in dark blue for values obtained with a previous lot,
- in light blue for values obtained with the current lot,
- in red when results are outside the acceptance range.

9 Day when quality controls were run.

10 Acceptance range of the quality control results for the current lot, expressed in primary
unit.

11 Mean, standard deviation and coefficient of variation for the results of the quality
controls of the day.

DAILY MEANS zone:


12 Display zone of the last 31 daily means.

The following indications are displayed:


- The day (d),
- The daily mean (Mean).

The indications are displayed:


- in dark blue for the previous lot,
- in light blue for the current lot,
- in red when daily means are outside the acceptance range.

13 Mean, standard deviation and coefficient of variation for the daily means from the
previous lot (displayed in dark blue).

14 Mean, standard deviation and coefficient of variation for the daily means from the
current lot (displayed in light blue).

If the operator changes the lot during the day, the mean is determined using the lot with the
largest number of controls. In case of equality, results from the new lot prevail.

MONTHLY MEANS zone:


15 Display zone of the last 12 monthly means.

The following indications are displayed:


- the month (M),

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- the monthly mean (Mean.),


- the monthly standard deviation (σ),
- the monthly coefficient of variation (cv).
The indications are displayed:
- in dark blue for the previous lot,
- in light blue for the current lot,
- in red when the monthly means are outside the acceptance range.

For the month when the lot was changed, the mean displayed is the one with the most
representative number of points.

9.4 Procedure to run and confirm quality controls

9.4.1 General principles


Quality controls for a given test are run automatically by the STA Satellite® as soon as it is
requested to perform an analysis corresponding to this test and as soon as the time elapsed
since the last control run is greater than the period defined in the TEST SETUP screens (see
chap. 5.1.3.4).
This period cannot exceed 24 hours. Quality controls can also be run on the operator’s
request from the following two screens:
- QUALITY CONTROL screen (Test list). In this case, all quality control levels of the selected
tests are run (simplified run, see description in chap. 9.4.5).
- Quality control result screen for a given level. In this case, only the level selected is run.

It is only possible to run controls on request if the sample pipetting has not been blocked
either:
- from the TEST STATUS screen (see description in chap. 10.1.3)
- from the STATUS sub-menu, STOP SAMPLE PIPETTING function (see description in
chap. 10.1.5.1).

Blocking tests through the FILE MODIFICATION screen blocks the quality control automatic
(periodic) run but does not block runs requested by the operator (see description in
chap. 8.7.3).

Quality controls are run either in single or in duplicate according to the determination type
selected for the sample (see description in chap. 5.1.1.7).
As soon as the results of a quality control are obtained, they are compared to the acceptance
range, if they are outside this range, the STA Satellite® automatically reruns other controls
according to the following principle:

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First run Result(s) STA Satellite®


Automatic rerun

Control run in single Outside the defined range Control rerun in duplicate

Control run in duplicate 1 of the 2 results is outside Control rerun in single


the defined range

If it is confirmed that the quality control is outside the acceptance range, all patient results
for the related test are displayed with the following alarm code: "Quality control: out of
range or not done"; they are displayed in light red on the TEST PANEL.
If the operator decides to accept quality control results declared out of range, all patient
results for the related test are displayed with the following alarm code: "Quality control:
overridden".
If quality controls have been run or rerun, when returning to the TEST PANEL, the STA
Satellite® performs a consistency check and displays the TEST STATUS screen (see
description in chap. 10.1.3).
If, upon running quality controls (automatic or on request), controls are not present inside
the product carousel (absent or present but with non usable volume or stability), and if the
time elapsed since the last quality control run is less than 24 hours, the STA Satellite® does
not perform the control, but proceeds with the assays for the related test and all patient
results for the related test are displayed with the following alarm code: "Quality control:
out of range or not done". In the same case, with an elapsed time greater than 24 hours,
sample pipetting for the related test are blocked.
If the lot number has been changed or if the quality controls have been reset, sample
pipetting for the related test starts again only when products required to perform the first
controls are loaded. Also, sample pipetting remains blocked as long as the range values
have not been defined for the test.

When the same controls (same identification number) are used for calibration controls
and quality controls, calibration control results are added to the quality control results
and the time when the calibration controls were run resets the clock for the quality
controls.

If the Online transmission option is activated (see chap. 10.1.5.2), then quality control
results are sent as soon as measurements are obtained, taking into consideration error
codes.

No alarm codes are sent for quality controls.

For description of alarm and error codes, see chap. 8.3.2. Each quality control result is
displayed with the run date and time.

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If the Online transmission is not activated, all confirmed results of the controls of the day
can be sent through the quality control result table (see chap. 9.6.5).

9.4.2 Quality controls loading


Quality controls are loaded into the product carousel (see description in chap. 6.3).
For each lot number change, range values for quality control from the STA Diagnostica
Stago product line are read through the barcode sheets included in each control box. For
other controls, range values must be entered manually.

For Diagnostica Stago controls, range values are properly dispatched into the related
tests, on condition that the primary unit for these test is the same as the one defined
on the package insert included in each control box (except Fibrinogen; for the primary
unit g/l, values are properly dispatched even if they are given in mg/dl on the package
insert).

9.4.3 Change range values for quality controls

This procedure is only possible if:


- the related control is not in progress, its status is to be confirmed or not done because
of missing products,
- the operator knows the access code to critical functions (see chap. 1.5).

For controls which are not from the STA® product line, range values must be defined at
every lot change so that controls can be run.

For controls from the STA® product line, the acceptance range can only be reduced, it
cannot beincreased in any case.

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2Quality control result screen (graphic mode) for a given level is displayed (see access in
chap. 9.2).

ACTIONS RESULTS

" Press Esc The following window is displayed:

" Move the cursor to Change range  The following window is displayed:
using the key then confirm by
pressing Enter

" Identify yourself (see chap. 4.9.13.5).  The following window is displayed:

with the cursor on the entry zone for new


values.
Legend:

1 Entry zone for new range values in


primary unit.
2 For controls from the STA product
line: range values read through bar
codes.
3 Recall of the primary unit.

" Type each new range value, confirm by  The Range modification window is
pressing Enter then save the new removed.
values using the F10 key
 The following window is displayed:

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ACTIONS RESULTS

" Identify yourself (see chap. 4.9.13.5).  The control result screen is displayed
again with the new range values.
 In the 2 zones, CONTROL OF THE DAY and
SUMS DAILY, all points outside the new
range are displayed in red.

9.4.4 One level quality control run

Run is impossible:
- if the control is already in progress or is to be confirmed,
- if calibration for the related test is not confirmed,
- if products required to perform the control are absent,
- as long as quality control range values have not been defined (see chap. 9.4.3).

2Quality control result screen (graphic mode) for the related test is displayed (see access in
chap. 9.2).

ACTIONS RESULTS

" Press Esc  The following window is displayed:

" Press R (Run)  The following window is displayed:


" OR move the cursor to Run using the
key, then confirm by pressing Enter

" Identify yourself (see chap. 4.9.13.5).  The STA Satellite® runs the quality
control on condition that the consistency
check does not lead to a blocking of the
sample pipetting.

" Press Esc then confirm by pressing  Return to the QUALITY CONTROL screen
Enter (Test list).

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9.4.5 Quality control simplified run

Run is impossible:
- for tests for which one of the controls is already in progress or to be confirmed.
- for tests which calibrations are not confirmed.
- if products required to perform the control are absent (see chap. 9.4.1).
- for tests which quality control range values have not been defined (see chap. 9.4.3).

2QUALITY CONTROL screen (Test list) is displayed (see access in chap. 9.2).

ACTIONS RESULTS

" For each test which quality controls are  If run is possible (all required products
requested, move the cursor to the test are loaded and control ranges are
abbreviation then confirm by pressing defined), the letter S is displayed on the
F1 left of each test abbreviation for which
controls are requested.
Note: To cancel a run request, press F1
 If run is impossible, an alert sound rings
and the letter S is not displayed.

" When all controls requested are  The following window is displayed:
marked, press F10

" Identify yourself (see chap. 4.9.13.5).  The letters S on the left of the test
abbreviations are removed.
 The STA Satellite® runs the quality
control on condition that the consistency
check does not lead to a blocking of the
sample pipetting.
 Colored squares on the left of the tests
abreviations concerned are displayed in
yellow on condition that the consistency
check does not lead to a blocking of the
sample pipetting. Otherwise, they are
displayed in red.

" Press Esc  The TEST STATUS screen is displayed


(see description in chap. 10.1.3).

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9.5 Procedures to observe for out of range quality controls

9.5.1 Message and alarm code displayed for out of range controls
When a quality control result is outside the acceptance range (out of range), the operator is
warned by the following message:

For the related test, all patient results are displayed with the following alert code: "Quality
control: out of range or not done" and the results are displayed in light red on the TEST
PANEL

9.5.2 Description of the OUT OF RANGE CONTROL window


This window is displayed when the operator accesses the quality control screen when one
of the results is out of range.

Fig. 4 - OUT OF RANGE QUALITY CONTROL window

Legend:

1 Test abbreviation

2 Quality control identification number

3 Results obtained for the quality control (in primary unit)

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4 Recall of the acceptance range for the quality control (in primary unit)

5 Recall of the mean for the Daily mean zone

6 Recall of the mean for the Monthly mean zone

7 Available functions:

Accept: accepts an out of range quality control (see chap. 9.5.2.1).


Rerun: reruns quality control (see description in chap. 9.5.2.2).
Postpone decision: returns to the QUALITY CONTROL screen (Test list).

9.5.2.1 Accept out of range quality controls

This procedure is only available if the operator knows the code which allows to accept out
of range controls (see chap. 1.5).

If the operator accepts quality control results although they are out of range, all patient
results for the related test will be displayed with the following alarm code "Quality
control: overridden".
In the OUT OF RANGE QUALITY CONTROL window, out of range results are displayed in red
and the acceptance range is displayed (see description in chap. 9.5.2).

2Quality control result screen is displayed with the OUT OF RANGE QUALITY CONTROL
window, the cursor is on Postpone decision.

ACTIONS RESULTS

" Press A (Accept)  The OUT OF RANGE QUALITY CONTROL


window is removed.
" OR move the cursor to Accept using
the key then confirm by pressing  The following window is displayed:
Enter

" Identify yourself (see chap. 4.9.13.5).  Depending on the value of the out of
range result, a red o or a red (out of
scale) is displayed in the CONTROLS OF
THE DAY area.

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ACTIONS RESULTS

" Press Esc then press Enter  Return to QUALITY CONTROL screen (Test
list).

9.5.2.2 Rerun out of range quality controls

When the STA Satellite® qualifies a quality control as out of range, the control has
already been run three times. Indeed, if the results are outside the acceptance range,
for a single determination test, the control is rerun in duplicate and, for a duplicate
determination, it is rerun in single (see description in chap. 9.4.1).
In the OUT OF RANGE QUALITY CONTROL window, out of range results are displayed in red
and the acceptance range is displayed (see description in chap. 9.5.2).

2Quality control result screen is displayed with the OUT OF RANGE QUALITY CONTROL
window, the cursor is on Postpone decision.

ACTIONS RESULTS

" Press R (Rerun)  The following window is displayed:


" OR move the cursor to Rerun using the
key then confirm by pressing Enter

" Identify yourself (see chap. 4.9.13.5).  The STA Satellite® reruns the quality
control on condition that the consistency
check does not lead to a blocking of the
sample pipetting.
 Return to quality control result screen
for the rerun level.

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9.6 Other available operations on quality controls

9.6.1 Cancelation of a control run

This function is not available if the control is confirmed, to be confirmed or not done. It is
only available for running controls (yellow square on the left of the test abbreviation).

2Quality control result screen (graphic mode) is displayed for a given level (see access in
chap. 9.2).

ACTIONS RESULTS

" Press Esc  The following window is displayed:

" Press C (Cancel)  The quality control run for the selected
level is cancelled.
" OR move the cursor to Cancel using
the key, then confirm by pressing
Enter

" Press Esc  Return to QUALITY CONTROL screen (Test


list).
 The colored square on the left of the
related test abbrevation is displayed in
red (not done).

" Press Esc  Return to TEST PANEL.

9.6.2 Delete controls of the day

This procedure is available only if the operator knows the access code to the critical
functions, (see chap. 1.5). It only concerns quality control results displayed in the
CONTROLS OF THE DAY zone (see definition of this zone in chap. 9.3.2, point 9).

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2 The quality control result screen (graphic mode) is displayed for a given level (see
access in chap. 9.2).

ACTIONS RESULTS

" Press F1  Quality control results for the level


selected are displayed in a table.

" Press F4  The following window is displayed:

" Type your acces code then confirm by  The following window is displayed:
pressing Enter
CONTROLS OF THE DAY DELETION
Del Delete
F5 Restore
F10 Save
Esc Cancel
 The cursor is on the first result of the
CONTROLS OF THE DAY zone

" For each result to be deleted, move the  Each result to be deleted is displayed in
cursor to the result using the key then grey.
press Del

" Press F10  The CONTROLS OF THE DAY DELETION


Note: As long as the F10 key has not window is removed.
been pressed, results can be restored  In the control of the day zone, selected
by pressing the Insert key results are removed.
 Mean, σ and cv are updated.

" Press Esc  Return to quality control results in


graphic mode.

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9.6.3 Delete all quality control results

For this function, the operator must know the access code to critical functions (see
chap. 1.5). This procedure deletes all quality control results for a given level.

This function is not available if the control is in progress or "to be confirmed".

2Quality control result screen (graphic mode) is displayed for a given level (see access in
chap. 9.2).

ACTIONS RESULTS

" Press Esc  The following window is displayed:

" Press D (Delete all values)  The following window is displayed:


" OR move the cursor to Delete all
results using the key then confirm by
pressing Enter

" Type your acces code then confirm by  The following window is displayed:
pressing Enter

" Type YES then confirm by pressing  All quality control results are deleted for
Enter the selected level.

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ACTIONS RESULTS

" Press Esc then confirm by pressing  Return to QUALITY CONTROL screen (Test
Enter list).

9.6.4 Print quality control results

9.6.4.1 Print quality control results as a graph

This function is available only if the STA Satellite® is in stand-by mode (no measurement
in progress) and if all printouts previously generated have been performed.

2Quality control result screen (graphic mode) is displayed for a given level (see access in
chap. 9.2).

ACTIONS RESULTS

" Press Esc  The following window is displayed:

" Press P (Print)  The following window is displayed:


" OR move the cursor to Print using the
key then confirm by pressing Enter

with the cursor on EXECUTE.

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ACTIONS RESULTS

" Press Enter  The following message "PRINTING" is


displayed at the bottom of the screen.
 The graphic representation of the quality
control results for the selected level is
printed.

" When the "Printing" message is  The PRINTOUT window is removed.


removed, press Esc
 Return to the quality control result
window for the selected level (graphic
mode).

9.6.4.2 Print quality control results as a table

This function is available only if the STA Satellite® is in stand-by mode (no measurement
in progress) and if all printouts previously generated have been performed.

2Quality control result screen (graphic mode) is displayed for a given level (see access in
chap. 9.2).

ACTIONS RESULTS

" Press F1  Quality control results for the selected


level are displayed in a table.

" Press F6  The following window is displayed:

with the cursor on EXECUTE.

" Press Enter  The following message "Printing" is


displayed at the bottom of the screen.
 The tabular representation of the quality
control results for the selected level is
printed.

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ACTIONS RESULTS

" When the "Printing" message is  The PRINTOUT window is removed.


removed, press Esc
 Return to quality control result table for
the selected level.

" Press Esc  Return to quality control results, graphic


mode.

9.6.5 Transmit quality control of the day


2Quality control result screen (graphic mode) is displayed for a given level (see access in
chap. 9.2).

ACTIONS RESULTS

" Press F1  Quality control results for the selected


level are displayed in a table.

" Press F11  The 2 following windows are displayed:


Transmitting
then,
Transmission completed
Esc = Clear this message
 All selected results for the quality
controls of the day are transmitted to the
Host computer with their respective run
date and time

" Press Esc  Return to the quality control result table


for the selected level.

" Press Esc  Return to quality control results, graphic


mode.

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9.7 Controls of the day

9.7.1 Description of the CONTROL OF THE DAY screen


Fig. 5 - Control of the day screen

Legend:

1 List of available keys:

Move the cursor in the control list and go to another page.


F6 - Print Print the screen
Esc Returns to TEST PANEL.
2 Screen name

3 Test abreviation

4 Control name

5 Running hour of the control

6 Control result in the main unit

7 Acceptance range

8 Status of the control

When the information line is displayed in:


Black: the quality control is confirmed

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Blue: the quality control is not done


Grey: the quality control is no more validated
Red: the quality control is out of limits or in error
Yellow: the quality control is in progress

9.7.2 Access to the controls of the day


2Test panel displayed.

ACTIONS RESULTS

" Press the Esc key  The Main menu is displayed:

with the cursor on Status.

" Press the C key (Calib./Control)  The following sub-menu is displayed:

with the cursor on Calibration.

" Move the cursor to Daily Controls  The DAILY CONTROL screen is displayed .
using the key, then press the Enter
 The cursor is on the first test of the list.
key to confirm

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Table of Contents

10 Miscellaneous screens .................................... 1

10.1 STATUS screens . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1


10.1.1 Access to the STATUS screens . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
10.1.2 SYSTEM STATUS screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
10.1.2.1 Description of the SYSTEM STATUS screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
10.1.2.2 Modify running mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
10.1.2.3 Modify level detection management . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
10.1.3 Description of the TEST STATUS screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
10.1.4 Description of the PRODUCT STATUS screen . . . . . . . . . . . . . . . . . . . . . . . . 8
10.1.5 Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
10.1.5.1 Stop sample pipetting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
10.1.5.2 Online transmission (YES/NO) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
10.1.5.3 Online printout (YES/NO) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10

10.2 GLOBAL OPTIONS Screens . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10


10.2.1 Access GLOBAL OPTIONS screens . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
10.2.2 First GLOBAL OPTIONS screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
10.2.2.1 Description of the first GLOBAL OPTIONS screen . . . . . . . . . . . . . . . . . . . . . . . . . . 11
10.2.2.2 Printout . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
10.2.2.3 Bar code reading . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
10.2.2.4 Miscellaneous . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
10.2.2.5 Arbitrary units . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
10.2.3 Second GLOBAL OPTIONS screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
10.2.3.1 Description of the second GLOBAL OPTIONS screen . . . . . . . . . . . . . . . . . . . . . . . . 14
10.2.3.2 Communications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
10.2.3.3 File acquisition . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
10.2.3.4 Miscellaneous . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
10.2.4 Modification of a GLOBAL OPTIONS parameter . . . . . . . . . . . . . . . . . . . . . . 18
10.2.4.1 Generalities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
10.2.4.2 Modification of a parameter with a free entry field . . . . . . . . . . . . . . . . . . . . . . . . . . 19
10.2.4.3 Modification of a parameter with a multiple choice field . . . . . . . . . . . . . . . . . . . . . . 19
10.2.4.4 Modification of the time display format . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
10.2.4.5 Modification of the date format . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
10.2.5 Saving of the parameters of the GLOBAL OPTIONS screens . . . . . . . . . . . . 26

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Miscellaneous screens

10 Miscellaneous screens
10.1 STATUS screens
The STATUS screens gather and display all information regarding:
- the system,
- the tests,
- the products: reagents, diluents, decontamination solutions, controls and calibrators.

10.1.1 Access to the STATUS screens


2TEST PANEL is displayed.

ACTIONS RESULTS

" Press Esc  The Main menu is displayed:

" Press Enter (Status)  The Status menu is displayed:

" Press the and keys or Press one of


the following keys:

- Enter (System),  The SYSTEM STATUS screen is displayed.

- T (Tests),  The TEST STATUS screen is displayed.

- P (Products).  The PRODUCT STATUS screen is


displayed.

" Press Esc  The Test panel is displayed.

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10.1.2 SYSTEM STATUS screen

10.1.2.1 Description of the SYSTEM STATUS screen


Fig. 1 - SYSTEM STATUS screen

Legend:

1 Available functions:

Esc Options, this key enables the display of the following window:

Level detection management : Changes the level detection option from "Managed" to
"Not managed" (see description of these two options in point 5 below).
Change running mode: Allows to select the running mode.
Quit: Return to TEST PANEL.

2 Current date and time.

3 Screen name.

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4 For the needle, when temperature is out of range, the STA Satellite® stops operating
and a red «NO» is displayed instead of «OK».

For the measurement zone (incubation), when temperature is out of range, the STA
Satellite® stops operating and a red «NO» is displayed instead of «OK».

For the product carousel, when temperature is out of range, a red «NO» is displayed
instead of «OK». Each result is displayed with a warning message: "Products
carousel: temperature out of range".

5 Level detection options for the needle:

Not managed (displayed in red):


- The level detection works but the software does not warn the operator when liquids are
not detected.
- The level detection does not work anymore, the STA Satellite® operates without level
detection control (the needle hits the bottom of the tube or vial).
In both cases, each result is displayed with a warning message informing the operator that
the level detection is not managed.

Managed (displayed in black):


The software warns the operator with error messages for all level detection problems.
The operator can switch the level detection option from "Managed" to "Not Managed" and
vice versa (see chap. 10.1.2.2).

6 Running mode

File: Tests are run file by file


Batch: Each test type is ran successively

7 Subtotal: Number of operating hours of the STA Satellite® since the last field service
engineer visit.

Total: Number of operating hours of the STA Satellite® since its installation.

8 Number of cuvettes remaining (displayed in black). When the number of cuvettes


remaining is 20 or less, the number is displayed in red.

Quantity of washing solution (STA - Cleaner Solution) remaining (displayed in black).


When the quantity of solution remaining is 50 mililiters or less, this number is displayed
in red.

9 Software version.

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10.1.2.2 Modify running mode


2SYSTEM STATUS screen is displayed.
ACTIONS RESULTATS

" Press Esc (Options)  The following window is displayed:

" Press the key (Change Running  "Batch" is displayed if "Patient" was
Mode), then confirm using Enter displayed previously.
 "Patient" is displayed if "Batch" was
displayed previously.

10.1.2.3 Modify level detection management

2SYSTEM STATUS screen is displayed.

ACTIONS RESULTS

" Press Esc (Options)  The following window is displayed:

" Press the key (Level detection  The following window is displayed:
management), then confirm using
Enter

" Decant all tubes from the sample  The level detection option turns to "Not
carousel. managed" (displayed in red).
" Press the key (Confirm), then  Results are displayed with an alarm
confirm using Enter code.

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If the level detection is deactivated, a message is displayed when the sample carousel or
product carousel opens.

10.1.3 Description of the TEST STATUS screen

This screen corresponds to a consistency check between the STA Satellite® workload
(number of tests to perform except blocked tests) and the requirements to complete this
task :
- products (cuvettes, washing solution, controls, calibrators, diluents, reagents),
- validated calibrations,
- validated quality controls.

The TEST STATUS SCREEN is displayed:


- upon request, from the STATUS menu,
- when closing the sample carousel and product carousel cover (see chap. 6.7),
- when tests are added to the Patient files from the FILE PROCESSING screens, accessible
from the Confirmation/Printout/Transmission menu or from the TEST PANEL (see chap.
8.3),
- when rerunning tests (see chap. 8.3 and 8.7.4),
- when running calibrations (see chap. 7.3.1.),
- when running quality controls (see chap. 9.4.1).

If the consistency check shows that one of the requirements to perform the workload is
missing, then sample pipetting (sample plasma, controls and calibrators) is blocked and the
message "Blocked sample pipetting" is displayed in white on a red background at the
bottom of the screen.

In this case, the operator can reactivate sample pipetting for tests that meet all conditions
(correct calibration, quality control, volume and stability of the products) by pressing Esc;
then Y.
Otherwise, if after the consistency check, all conditions are met, sample pipetting continues
or starts again, the Esc key returns directly to the TEST PANEL.
This screen is updated every 5 minutes.

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Fig. 2 - TEST STATUS screen

Legend:

1 List of available functions:

F6 To print out the screen data.


Esc To return to the TEST PANEL:
- directly if the following message "BLOCKED SAMPLE PIPETTING" is not displayed at the
bottom of the screen,
- through a confirmation window if the following message "BLOCKED SAMPLE PIPETTING" is
displayed at the bottom of the screen (see description in chap. 6.7)

2 Current date and time.

3 Screen name.

4 Quantity of cuvettes and washing solution (STA - Cleaner Solution) currently available.

5 Quantity of cuvettes and washing solution (STA - Cleaner Solution) that will theorically
remain after all tests are run. When values are positive (surplus), they are displayed
in grey. When they are negative (quantity not sufficient to perform tests), values are
displayed in red.

6 Total number of tests to be run (including blocked tests), not taking calibrations and
controls into account.

7 Number of remaing tests.

8 Alphanumerical identification of the product. The (*) symbol indicates the risk of end of
stability before the estimated end of the tests.

9 Product name.

10 Margin: quantity that should theoretically remain after all tests are run.

- A positive value indicates a surplus, it is displayed in grey.

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- A negative value indicates a lack of product, it is displayed in red.


These products are reloaded so that the STA Satellite® can complete all remaining tests.

In case of negative margins, zones 9 (Identification) and 10 (Name) are also displayed in
red.

The products are sorted by order of priority:


- products with negative margin (and possibly stability problems),
- products with risk of stability overdue,
- products without problems.

Upon display of the TEST STATUS screen, the cursor is on the first product. The and keys
move the cursor from one product to another so they can all be displayed.

11 Abbreviation of the requested test.

12 Calibration status:

- Not done
- In progress
- Control out (out of range control)
- To be validated
- Validated

13 Quality control status:

- In progress
- Out of range
- Validated
- Not done

Upon display of the TEST STATUS screen, the cursor is on the first product. The key moves
the cursor to the display zone: test status zone, then the and keys moves the cursor
from one test to another.

14 The message "Blocked sample pipetting" is displayed in white on a red background


at the bottom of the screen when sample pipetting is blocked:

- by the operator (Stop sample pipetting function, see chap. 10.1.5.1).


- by the STA Satellite® after the consistency check, if the requested tests cannot be run.

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10.1.4 Description of the PRODUCT STATUS screen


Fig. 3 - PRODUCT STATUS screen

Legend:

1 List of available keys:

Esc Returns to TEST PANEL

2 Current date and time

3 Screen name

4 Product alphanumerical identification (reagents, diluents, decontamination solutions,


controls or calibrators) as it is defined in the TEST SETUP screens (see chap. 5.1).
It is displayed in blue. It is displayed in red in case of insufficient volume, level detection
problems or expired stability. Products with problems are displayed at the beginning of
the list.

5 Product name (reagents, diluents, decontamination solutions, controls or calibrators) as it


is defined in the TEST SETUP screens (see chap. 5.1).

6 Product position (reagents, diluents, decontamination solutions, controls or calibrators)


in the product carousel and identified as:
Carousel number + product position in the carousel.

7 Product lot number (reagents, diluents, decontamination solutions, controls or


calibrators) currently loaded in the product carousel.
Empty field for products with non-managed lots.

8 Product current volume (reagents, diluents, decontamination solutions, controls or


calibrators).

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The STA Satellite® takes as starting point the volume of the vial after reconstitution as
specified in the TEST SETUP screens (see chap. 5.1). The volume can be modified
during loading (see chap. 6.3).

After each sample pipetting, the vial volume is decreased by the sample volume, as
specified in the TEST SETUP screens (see chap. 5.1).

When the volume reaches the "Minimum volume" value defined in the TEST SETUP
screens, then this "Minimum volume " value is displayed in red as well as the
alphanumerical identification of the related product.

If, in comparison with the theorical volume decrease, the STA Satellite® does not
detect the liquid level, then the volume displayed is 0, it is displayed in red; the
alphanumerical identification of the related product is also displayed in red and the
product is forbidden.

9 Theorical stability end for each product expressed by the day, the month and the time.

To calculate this value, the STA Satellite® uses the stability (t) defined in the TEST SETUP
screens (see chap. 5.1). The stability can be corrected during the product loading
(see chap. 6.3).

From the loading of each product (t0), the STA Satellite® proceeds to the following
sum:

t0 + t = T T =Displayed stability end.

The display color of the stability end and of the alphanumerical identification depend on the
following conditions:

Current date and time Product alphanumerical End of stability


identification (T)

Until T - (1 hour) Blue Blue

From [ T - (1 hour) ] to T Blue Red

After T Red "Completed" is displayed


in red

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10.1.5 Options

10.1.5.1 Stop sample pipetting


This option is automatically set to YES by the STA Satellite® if, after selecting new tests to
run (sample tubes, controls or calibrations), one of the following conditions is not met:
- sufficient volume,
- no risk of stability overdue,
- calibration done and validated,
- quality control done.
The operator may decide to unblock some tests (see chap. 10.1.3).Switching the option to
NO to proceed.
The operator can also use this option to stop the sample pipetting by switching this option from
NO to YES. In this case, all sample pipetting (including calibrators and controls) are blocked.
However, the STA Satellite® finishes the assays in progress for all cuvettes located on the
incubation plate.

10.1.5.2 Online transmission (YES/NO)


When YES is selected for this option, results are sent one by one to the host computer as
soon as they are obtained, in accordance with conventions described in chap. 9.4.1.

10.1.5.3 Online printout (YES/NO)


When YES is selected for this option, Patient files are automatically printed as soon as all
tests of the Patient file have been run.

New printout requests are impossible as long as there are printouts in progress.

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10.2 GLOBAL OPTIONS Screens


These screens are used to define parameters specific to the laboratory:
address, access codes, type of information to enter for Patient files, communication
parameters and miscellaneous.

10.2.1 Access GLOBAL OPTIONS screens

Access to these screens is only available if:


- the STA Satellite® is in stand-by mode (no measurement in progress),
- the operator knows the required access code.

2TEST PANEL is displayed.

ACTIONS RESULTS

" Press Esc  The Main menu is displayed:

" Press E (Setup)  The following menu is displayed:


" OR press the key to move the cursor
to Setup then confirm using Enter

" Press O (Global Options)  The following window is displayed:


" OR press the key to move the cursor
to Global Options then confirm using
Enter

" Identify yourself (see chap. 4.9.13.5).  The first GLOBAL OPTIONS screen is
displayed (see description below in
chap. 10.2.2.1).

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10.2.2 First GLOBAL OPTIONS screen

10.2.2.1 Description of the first GLOBAL OPTIONS screen


Fig. 4 - GLOBAL OPTIONS screen, page 1of 2

Legend:

1 List of available keys:

Esc Allows to display the Exit Options window (see description in chap. 10.2.5).
Allows to display the second GLOBAL OPTIONS screen.

2 Screen name.

3 Date of the last saving of the GLOBAL OPTIONS screens.

4 Printout parameters.

5 Reading parameters for the bar code reader.

6 Definition of the arbitrary units.

7 Miscellaneous section.

The definition of each parameter is described in the following pages.

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10.2.2.2 Printout
Identification of the laboratory as it appears on the result printout.

Title 1 First line for the laboratory identification.


(34 characters)

Title 2 Second line for the laboratory identification.


(34 characters)

10.2.2.3 Bar code reading


If the laboratory uses barcode identifications for patients, only a part of the bar code may be
used.
In this case, it is possible to define which digits are not significant.

Non significant digit(s) Leading / Number of digits to delete on the left and/or
ending on the right (1 character).

10.2.2.4 Miscellaneous

Desorb by default Alphanumerical identification of the


(8 characters) decontamination solution to use by default
at each STA Satellite® startup.

Alarm sound Definition of the alarm type.


There are two possibilities :
- YES: alarm sound emitted when error
messages are displayed
- NO: No alarm sound emitted when error
messages are displayed

Auto. Sample Validation Validation type definition for unread tubes.

There are two possibilities :


- YES: Automatic validation for unread
barcode
- NO: Manual validation requested for
unread barcode

10.2.2.5 Arbitrary units

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The laboratory can create 1 to 3 new units.

Name Unit name.


(5 characters)

Decimal numeral Definition of the number of characters after


the decimal point.
Reminder: each result is displayed with
5 characters including the decimal point.
Possible choices: 1, 2, 3.

10.2.3 Second GLOBAL OPTIONS screen

10.2.3.1 Description of the second GLOBAL OPTIONS screen


Fig. 5 - GLOBAL OPTIONS screen, page 2 of 2

Legend:

1 List of available keys:

Esc Allows to display the EXIT OPTIONS window(see description in chap. 10.2.5).
Allows to display the first GLOBAL OPTIONS screen.
2 Screen name.

3 Communication parameters (ASTM protocol).

4 File acquisition parameters.

5 Miscellaneous section:

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- Definition of the time display format.


- Definition of the date display format.
6 Printer section

Definition of each parameter is described in the following pages.

10.2.3.2 Communications
The following parameters are used to define the characteristics required for transmission to
the host computer (ASTM protocol) :

Station number (0...99) Allows the host computer to identify the


(2 characters) STA Satellite®.

Bauds rates Transmission speed, options:


300, 600, 1200, 2400, 4800, 9600 Bauds.

Parity Type of parity selected, three options: none,


even or odd.

Number of DATA bits Options: 7 or 8.

Number of STOP bits Options: 1 or 2.

Number of On error retries Number of times the STA Satellite® sends


each frame after receiving a NACK
message. For consistency with the ASTM
E1381 - 91 standard, this number is set to 6
by default.

Send sequence number There are two possibilities:


- YES: The sequence number is sent
- NO: The sequence number is not sent

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Patient data check There are two options:


- YES: The first four patient identification
fields are sent by the host computer at
the same time as the workload. These
fields can be checked during sample
loading (see File acquisition section in
chap. 10.2.3.3).
- NO: The first four patient identification
fields are sent by the host computer at
the same time as the workload. These
fields cannot be checked during sample
loading (see file acquisition section in
chap. 10.2.3.3).

Printer Options: internal or external printer

10.2.3.3 File acquisition


ˆ Civil status:
The Patient files civil status is divided in 5 fields.
The first ID field (Item 1) cannot be modified: 16 alphanumerical characters.
The laboratory may define the other four fields as desired, taking into consideration that the
number of alphabetical characters per field is preset as follows:
- Item 2: 16 alphanumerical characters.
- Item 3: 12 alphanumerical characters.
- Item 4: 6 alphanumerical characters.
- Item 5: 4 alphanumerical characters.
Only defined fields can be used.
Each field name can use 12 characters.

ˆ ID type:
There are two options:
- Numerical
- Alphanumerical

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10.2.3.4 Miscellaneous
The following parameters are used to define:
- The time display format
- The date display format

To type special characters such as: /, *, :, etc..., hold the Symb key pressed and press the
numerical keyboard key corresponding to the desired character.

Time format Display format options:


- 0 - 24h format
- 0 - 12h format
A format chain used as acquisition help can
also be defined. (example: hh : mm : ss).

Possible options for the separator:


- /
- :
- -
- .
- ,

Date format Possible options for the display format:


- day - month - year format
- month - day - year format
- year - month - day format
A format chain used as acquisition help can
also be defined (example: dd / mm / yyyy).

Possible options for the separator:


- /
- :
- -
- .
- ,

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10.2.4 Modification of a GLOBAL OPTIONS parameter

10.2.4.1 Generalities

This procedure is available only if:


- the STA Satellite® is in stand-by mode (no measurement in progress),
- the operator knows the access codes to the GLOBAL OPTIONS screen.

Moreover, modifying some parameters may have very important consequences on:
- the reading of the barcode used for the sample tubes,
- the transmission of the results to the host computer.

Parameters displayed in grey cannot be modified, only parameters displayed in blue or


white can be modified.

To type special characters such as: /, *, :, etc..., hold the Symb key pressed and press
the numerical keyboard key corresponding to the desired character.

With the cursor on the parameter to modify, two options are available:
- Free entry field: in this case, no message is displayed at the bottom of the screen, the
parameter and the cursor are displayed in blue.
- Multiple choice field: in this case, the message "DEL key = Modify" is displayed at the
bottom of the screen, the parameter and the cursor are displayed in white. Del allows
either to scroll among different choices or to display choices in a window (time format,
date format, type of printer), see modification procedure below in chap. 10.2.4.3 to
10.2.4.5.

10.2.4.2 Modification of a parameter with a free entry field

2GLOBAL OPTIONS screen is displayed (page 1or page 2), the cursor is on a parameter
displayed in blue.

ACTIONS RESULTS

" Type the new information on the  The new information is displayed.
alphanumerical keyboard then confirm
 The cursor moves to the next parameter.
using Enter

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10.2.4.3 Modification of a parameter with a multiple choice field


2GLOBAL OPTIONS screen is displayed (page 1or page 2), the cursor is on a white
parameter and the message "DEL key = Modification" is displayed at the bottom of the
screen.

ACTIONS RESULTS

" Press Del  Different available options are


displayed.

" When the desired option is displayed,  The selected option is displayed.
press Enter
 The cursor moves to the next parameter.

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10.2.4.4 Modification of the time display format


2GLOBAL OPTIONS screen (page 2 of 2) is displayed with the cursor next to Time Format.

ACTIONS RESULTS

" Press Del " The TIME FORMAT window is displayed:


TIME FORMAT
Separator
17*35*24
05*35*24 p
International Time
17 H 35 M 24 S
with the cursor on Separator.
Display of the separator (*) according to
the last selection.

Separator selection

2The TIME FORMAT window is displayed with the cursor on Separator.

ACTIONS RESULTS

" Press Enter to change the separator if  The different available separators are
necessary displayed in the following window:
/ : - . ,
with the cursor on the / key.

" Move the cursor to the desired  The TIME FORMAT window is displayed:
separator, then confirm using Enter
TIME FORMAT
Separator
17*35*24
05*35*24 p
International time
17 H 35 M 24 S
with the cursor on Separator.
 The separator (*) is updated.

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Miscellaneous screens

Format : 0 - 24 h

2The TIME FORMAT window is displayed with the cursor on Separator.

ACTIONS RESULTS

" Press the key until you reach  The TIME ABBREVIATION window is
17*35*24p, then confirm using Enter displayed:
TIME ABBREVIATION
hh*mm*ss
(Hours : Minutes : Seconds)
with the cursor on the first letter of the
display time format.
Separator (*) as defined previously.

" Check the abbreviations for hour,  The TIME FORMAT window is displayed:
minute and second, modify them if
TIME FORMAT
necessary then press Enter
Separator
17*35*24
05*35*24 p
International time
17 H 35 M 24 S
with the cursor on 17*35*24

" Press Esc  Return to page 2 of the GLOBAL OPTIONS


screen with the cursor next to Time
Format.
 Time format abbreviations are updated.

Format: 0 - 12 h

2The TIME FORMAT window is displayed with the cursor on Separator.

ACTIONS RESULTS

" Press the key until you reach  The TIME ABBREVIATION window is
05*35*24 p, then confirm using Enter displayed:
TIME ABBREVIATION
hh*mm*ss
Note: p = p-m
(Hours : Minutes : Seconds)
a = a-m
with the cursor on the first letter of the
time display format.
Separator (*) as you defined it
previously.

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ACTIONS RESULTS

" Check the abbreviations for hour,  The TIME FORMAT window is displayed:
minute and second, modify them if
TIME FORMAT
necessary then press Enter
Separator
17*35*24
05*35*24 p
International time
17 H 35 M 24 S
with the cursor on 05*35*24 p

" Press Esc " Return to page 2 of the GLOBAL OPTIONS


screen with the cursor next to Time
Format.
" Time format abbreviations are updated.

10.2.4.5 Modification of the date format


2GLOBAL OPTIONS screen (page 2 of 2) is displayed with the cursor next to Date Format.

ACTIONS RESULTS

" Press Del  The DATE FORMAT window is displayed:


DATE FORMAT
Separator
06*08*1993
1993*08*06
08*06*1993
For year = 1993
Month = 8
Day = 6
with the cursor on Separator
 Separator display (*) according to the
last selection.

Separator selection

2The DATE FORMAT window is displayed with the cursor on Separator.

ACTIONS RESULTS

" Press Enter to change the separator  The different available separators are
displayed in the following window:
/ : - . ,
with the cursor on the / key.

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Miscellaneous screens

ACTIONS RESULTS

" Move the cursor to the desired  The DATE FORMAT window is displayed:
separator, then confirm using Enter DATE FORMAT
Separator
06*08*1993
1993*08*06
08*06*1993
For year = 1993
Month = 8
Day = 6
with the cursor on Separator
 The separator (*) is updated.

Format: day * month * year

2The DATE FORMAT window is displayed with the cursor on Separator.

ACTIONS RESULTS

" Press Enter until you reach  The DATE ABBREVIATION window is
06*08*1993, then confirm using Enter displayed:
DATE ABBREVIATION
jj*mm*aaaa
Example
France jj.mm.aaaa
USA mm/dd/yyyy
with the cursor on the first letter of the
date display format.
Separator (*) as defined previously.

" Check the abbreviations for the  The DATE FORMAT window is displayed:
day,month and year, modify them if
DATE FORMAT
necessary, then confirm using Enter
Separator
06*08*1993
1993*08*06
08*06*1993
For year = 1993
Month = 8
Day = 6
with the cursor on Separator.

" Press Esc  Return to page 2 of the GLOBAL OPTIONS


screen with the cursor next to Date
Format.
 Date format abbreviations are updated.

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Miscellaneous screens

Format: year * month * day

2The DATE FORMAT window is displayed with the cursor on Separator.

ACTIONS RESULTS

" Press Enter until you reach  The DATE ABBREVIATION window is
1993*08*06, then confirm using Enter displayed:
DATE ABBREVIATION
yyyy*mm*dd
Example
France dd.mm.yyyy
USA mm/dd/yyyy
with the cursor on the first letter of the
date display format.
Separator (*) as defined previously.

" Check abbreviations for the day, month  The DATE FORMAT window is displayed:
and year, modify them if necessary,
DATE FORMAT
then confirm using Enter
Separator
06*08*1993
1993*08*06
08*06*1993
For Year = 1993
Month = 8
Day = 6
with the cursor on Separator.

" Press Esc  Return to page 2 of the GLOBAL OPTIONS


screen with the cursor next to Date
Format
 Date format abbreviations are updated.

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Miscellaneous screens

Format: month * day * year

2The DATE FORMAT window is displayed with the cursor on Separator.

ACTIONS RESULTS

" Press Enter until you reach  The DATE ABBREVIATION window is
08*06*1993, then confirm using Enter displayed:
DATE ABBREVIATON
mm*dd*yyyy
Example
France dd.mm.yyyy
USA mm/dd/yyyy
with the cursor on the first letter of the
date display format.
Separator (*) as defined previously.

" Check the abbreviations for the day,  The DATE FORMAT window is displayed:
month and year, modify them if
DATE FORMAT
necessary, then confirm using Enter
Separator
06*08*1993
1993*08*06
08*06*1993
For Year = 1993
Month = 8
Day = 6
with the cursor on Separator.

" Press Esc  Return to page 2 of the GLOBAL OPTIONS


screen with the cursor next to Date
Format.

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10.2.5 Saving of the parameters of the GLOBAL OPTIONS screens


2GLOBAL OPTIONS screen (page 1 or 2) is displayed.

ACTIONS RESULTS

" Press Esc  The EXIT OPTONS window is displayed:

with the cursor on Save and quit.

" Press Enter  Modifications are saved


 A logo is displayed and a check of some
parameters is performed.
If a problem is detected, an error
message is displayed.
 Return to TEST PANEL

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Table of Contents

11 Troubleshooting .......................................... 1

11.1 Messages displayed . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1


11.1.1 Error messages with error number . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
11.1.2 Blocking error messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

11.2 Problems with results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8


11.2.1 List of points to be checked . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

11.3 Problem with the test run . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

11.4 Other problems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10


11.4.1 Power-on problems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
11.4.2 Problems regarding cuvettes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
11.4.3 Problems regarding fuses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

11.5 Problems regarding tube reading . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

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Troubleshooting

11 Troubleshooting
11.1 Messages displayed
- Error messages with error number, see chap. 11.1.1.
- Blocking error messages, see chap. 11.1.2.

11.1.1 Error messages with error number


Fig. 1 - Description of the error window

Legend:

1 Concerned part of the analyzer

2 Message deletion

3 Error type

4 Error number

5 Description

Note The first two digits of the error number correspond to the error type.

The procedure to turn off the STA Satellite® is described in chap. 3.7.

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Troubleshooting

Error type Part(s) concerned Procedure

01 ˆ Needle rinsing " Load a vial of STA®-Desorb U into


Lack of product the products carousel (see
LAUNCHER chap. 6.3).
" If the problem remains, call your
local authorized Service
Representative.

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Troubleshooting

Error type Part(s) concerned Procedure

02 ˆ Rinsing " Press ALT & F10 simultaneously.


Counter
 The User Maintenance menu is
ARM
displayed.
MANAGEMENT
" Press Esc to exit the User
Maintenance menu.
 The STA Satellite® reboots and
reruns tests.

" If the problem remains, call your


local authorized Service
Representative.

ˆ Sample suction " Press the Esc key.


Insufficient liquid level
" Transfer the remaining liquid into a
microcup.
" Access the Loading menu to reload
the sample (see chap. 6.4 ).
" Rerun tests (see chap. 6.7).

" If the problem remains, call your


local authorized Service
Representative.

ˆ Sample suction " Press ALT & F10 simultaneously.


Time out
 The User Maintenance menu is
displayed.
Uncompleted
movements " Check that there is no capped tubes
and that all tubes are properly
Impossible movements inserted in the carousel. Do not
move tubes.
" Press Esc to exit the User
Maintenance menu.
 The STA Satellite® reboots and
reruns tests.

" If the problem remains, call your


local authorized Service
Representative.

ˆ Sample distribution " Turn the STA Satellite® off.


Stuck cuvettes
" Clean the rail as described in chap.
ˆ Product distribution 4.6.2.
Stuck cuvettes
" If the problem remains, call your
local authorized Service
Representative.

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Troubleshooting

Error type Part(s) concerned Procedure

03 ˆ Carousel initialization " Press ALT & F10 simultaneously.


Bar code reader
 User Maintenance menu is
PRODUCT
ˆ Uncompleted displayed.
CAROUSEL
movement " Press Esc to exit the User
MANAGEMENT
Maintenance menu.
 The STA Satellite® reboots and
reruns tests.

" If the problem remains, turn the STA


Satellite® off.
" Remove the product carousel and
place it on a flat area.
" Check the state of the bar code label
on the side of the product carousel.
" Clean this label with a lint-free cloth
slightly moistened with water.
" Check and, if necessary, clean the
product glass (see procedure in
chap. 4.6.5).
" If the problem remains, call your
local authorized Service
Representative.

04 ˆ Carousel initialization " Press ALT & F10 simultaneously.


Bar code reading
 User Maintenance menu is
SAMPLE
displayed.
CAROUSEL
MANAGEMENT " Press Esc to exit the User
Maintenance menu.
 The STA Satellite® reboots and
reruns tests.

" If the problem remains, call your


local authorized Service
Representative

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Troubleshooting

Error type Part(s) concerned Procedure

05 ˆ Rail " Press the Esc key


Out of range
" Check the temperature of the parts
BACKTASK temperature
that might be concerned (rail,
product carousel, etc.) in the System
menu (see chap. 10.1.2 ).
" Check the room temperature: it
should be between 15°C and 32°C
for a good running order of the STA
Satellite®.

" Make sure that the air vents located


under the STA Satellite® are not
blocked.

" Take a long flat tool (eg.: a ruler)


wrapped in dry absorbent paper
towel.

" Pass the absorbent paper towel


under the STA Satellite® without
lifting the STA Satellite® up.

" If the problem remains, call your


local authorized Service
Representative.

ˆ Cleaner bin container " Check the connection between the


Check presence used liquid bottle and the STA
Satellite®.
" Check that the cap is properly set.

" If the problem remains, call your


local authorized Service
Representative.

ˆ Cleaner bin container " Proceed with the liquid waste


Container full container change according to the
procedure described in chap. 3.6.3.

" If the problem remains, call your


local authorized Service
Representative.

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Troubleshooting

Error type Part(s) concerned Procedure

ˆ Cover opening not " Press ALT & F10 simultaneously.


allowed
 User Maintenance menu is
Measurement cover
displayed.
Carousel cover
" Make sure that the rail, samples and
products covers are properly closed.
" Press Esc to exit the User
Maintenance menu.
 The STA Satellite® reboots and
reruns tests.

" If the problem remains, call your


local authorized Service
Representative.

06 ˆ Communication error " Press ALT & F10 simultaneously.


PCX
 User Maintenance menu is
COMMUNICATION
displayed.
MANGEMENT
" Press Esc to exit the User
Maintenance menu.
 The STA Satellite® reboots and
reruns tests.

" If the problem remains, turn the STA


Satellite® off for 5 minutes.
" If the problem still remains, call your
local authorized Service
Representative.

07 ˆ Communication error " Press ALT & F10 simultaneously.


 User Maintenance menu is
MEASUREMENT
displayed.
COMMUNICATION
MANAGEMENT " Press Esc to exit the User
Maintenance menu.
 The STA Satellite® reboots and
reruns tests.

" If the problem remains, turn the STA


Satellite® off for 5 minutes.
" If the problem still remains, call your
local authorized Service
Representative.

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REFERENCE MANUAL
11
Troubleshooting

Error type Part(s) concerned Procedure

08 ˆ Communication " Press ALT & F10 simultaneously.


Maximum numbers of
 User Maintenance menu is
GTL repetitions
displayed.
COMMUNICATION
MANAGEMENT " Press Esc to exit the User
Maintenance menu.
 The STA Satellite® reboots and
reruns tests.

" If the problem remains, turn the STA


Satellite® off for 5 minutes.
" If the problem still remains, call your
local authorized Service
Representative.

09 ˆ Host system " Confirm the message.


communication
" Check the plug connection.
HOST SYSTEM
COMMUNICATION
" If the problem remains, turn the STA
Satellite® off for 5 minutes.
" If the problem still remains, call your
local authorized Service
Representative.

10 ˆ Cuvette movement " Turn off the STA Satellite®.


Stuck cuvettes
CUVETTE
" Proceed rail cleaning according to
MANAGEMENT
the procedure described in chap.
4.6.2.

No cuvette " Proceed cuvette roll change


according to the procedure
described in chap. 3.4.

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11 REFERENCE MANUAL
Troubleshooting

Error type Part(s) concerned Procedure

Rewound cuvettes " Proceed troubleshooting according


to the procedure described in chap.
4.6.3.

12 ˆ Products carousel " Press ALT & F10 simultaneously.


initialization
 User Maintenance menu is
MACHINE Auto-zero
displayed.
INITIALIZATION
ˆ Samples carousel " Press Esc to exit the User
initialization Maintenance menu.
Auto-zero
 The STA Satellite® reboots and
reruns tests.

" If the problem remains, call your


local authorized Service
Representative

ˆ Cuvette initialization " Check the presence of the cuvette


bin.
" Make sure that the rail cover is
properly closed.
" Press ALT & F10 simultaneously.
 User Maintenance menu is
displayed.
" Clean the rail as described in
chap 4.6.2.
" Press Esc to exit the User
Maintenance menu.
 The STA Satellite® reboots and
reruns tests.

" If the problem remains, call your


local authorized Service
Representative.

ˆ Rail initialization " Turn the STA Satellite® off.


Stuck cuvettes
" Clean the rail as described in
chap. 4.6.2.

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11
Troubleshooting

Error type Part(s) concerned Procedure

ˆ Photometry check Follow the instructions:


Erroneous status
" Press ALT & F10 simultaneously.
" Switch the STA Satellite® off.
" Switch the STA Satellite® back on.
 The STA Satellite® reboots and
reruns tests.

" If the problem remains, call your


local authorized Service
Representative.

13 ˆ Measurement error Follow the instructions:


" Press ALT & F10 simultaneously.
MEASUREMENT
MANAGEMENT " Turn off the STA Satellite®.
" Turn back on the STA Satellite®.
 The STA Satellite® reboots and
reruns tests.

" If the problem remains, call your


local authorized Service
Representative.

ˆ Clotting time " Turn the STA Satellite® off.


Stuck cuvettes
" Clean the rail as described in chap.
4.6.2.

ˆ Host system " Confirm the message.


communication
" If no host system is used, make sure
that "On-line transmission" is set on
"NO", see procedure in chap. 8.4.3.
" If the problem remains, turn the STA
Satellite® off for 5 minutes.

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Troubleshooting

Error type Part(s) concerned Procedure

14 ˆ Communication Follow the instructions:


" Press ALT & F10 simultaneously.
BC READER
COMM " Switch the STA Satellite® off.
MANAGEMENT
" Switch the STA Satellite® back on.
 The STA Satellite® reboots and
reruns tests.

" If the problem remains, call your


local authorized Service
Representative.

52 ˆ No carousel Follow the instructions:


" Proceed with installation of the
SAMPLE
sample carousel.
LOADING

53 ˆ No carousel Follow the instructions:


" Proceed with installation of the
PRODUCT
product carousel.
LOADING

11.1.2 Blocking error messages


Type 1: “Run time error .............” is displayed in a window.
“Disk Error.....................” is displayed anywhere on the screen.
“Fatal Error ....................” is displayed anywhere on the screen.

Type 2: “HF XX Error .................” is displayed in yellow at the bottom of the


screen.
“HS XX Error .................” is displayed in black on a grey background.

Procedure if a type 1 or type 2 message is displayed:


" Write down the error displayed.
" Switch the STA Satellite® off during 5 minutes.
" Switch the STA Satellite® back on.
" If the problem remains, call your local authorized Service Representative and give the
written information.

11.2 Problems with results

11.2.1 List of points to be checked


When a problem is found in the results, the following items must be checked:
1 Check that the mechanical and robotic items are in good running order.

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REFERENCE MANUAL
11
Troubleshooting

2 Check the rinsing volumes. Run the Rinse function in the User Maintenance menu
(see chap. 4.9.2.2).

3 Run a quality control and compare the results with previous results.

4 Check samples:
- Poor centrifugation
- Insufficient volume
- Presence of clots or micro-clots
- Presence of bubbles, etc.

5 Check the methodology: check the set-up of the test(s) causing the problem, and
compare with the test set-up recommended by Diagnostica Stago.

6 Check reagents:
- For example: reagent incorrectly reconstituted.
In this case, load a new reagent vial.

7 Run quality control for a major test and compare the results to previous results

8 Check the other routine tests run on the same patient sample.

9 Check that the weekly maintenance has been carried out.

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11 REFERENCE MANUAL
Troubleshooting

11.3 Problem with the test run

Problem(s) Probable cause(s) Possible solution(s)

For a given test, assays are  The test had been " Unblock test (see
not run. blocked through the procedure in chap.
Global modification 8.7.3).
menu (see chap. 8.7.3).
"Block" is displayed in
red on the TEST PANEL
for this test.
 Some required products
are missing. " Refer to the TEST
STATUS screen: missing
products are displayed
in red (see description in
chap. 10.1.3).
" Load the missing
products if necessary.
 No confirmed calibration
for this test. " Refer to the TEST
STATUS screen: the
status of the calibration
for the test concerned is
not: Confirmed (see
description in chap.
10.1.3 )
 For this test, no quality
control has been run for " Run calibration for this
more than 24 hours. test.
" Check the TEST STATUS
screen: the quality
control status for this
test is not: Confirmed
(see description in
chap. 10.1.3).
" Run a quality control for
this test.

None of the assays is run.  Sample pipetting has " Reload the missing
been blocked: either products if necessary
with the STOP SAMPLE (see list in the TEST
PIPETTING function in the STATUS screen).
Status sub-menu (see
" Run the missing
description in
calibrations (see list in
chap. 10.1.5.1 ) or in the the TEST STATUS
TEST STATUS screen
screen).
(see description in
chap.chap. 10.1.3 ). " Run the missing quality
controls (see list in the
TEST STATUS screen).

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11
Troubleshooting

11.4 Other problems

11.4.1 Power-on problems

Problem(s) Probable cause(s) Possible solution(s)

No response for the  The power supply cable " Connect the power
keyboard and the STA is not connected. supply cable correctly.
Satellite® does not start.
 The power outlet is not " Plug the STA Satellite®
working. to another power outlet.

 The main fuses have " Replace the main fuses


blown. (see chap. 4.7.3).

 The analyzer is out of " Call your local


order. authorized Service
Representative.

11.4.2 Problems regarding cuvettes

Problem(s) Probable cause(s) Possible solution(s)

Rail problem  Wrong cuvette shifting. " Proceed cleaning of


the rail with dismantling
 Damaged cuvettes.
of the rail cover as
 Stuck or overturned described in chap. 4.6.2.
cuvettes.

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11 REFERENCE MANUAL
Troubleshooting

11.4.3 Problems regarding fuses

Problem(s) Probable cause(s) Possible solutions

Empty screen.  Damaged F3 fuse. " Switch the analyzer off.


No response from " Replace fuse F3 (see
keyboard. chap. 4.7.3).
Light signal for fuse F3 is " If the problem happens
off. again, contact your
local authorized Service
Representative.

RISK OF BIOLOGICAL CONTAMINATION


RISK OF INJURY
Do not touch the bin.
Do not touch the cutter.

11.5 Problems regarding tube reading

Likely cause(s) Possible solution(s)

" Badly positioned label  The label bars must be perpendicular to


the tube axis:

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11
Troubleshooting

Likely cause(s) Possible solution(s)

 If labels are already stuck on the tube: completely cover their bar codes when
applying the new label.
 Do not use damaged labels
 Tubes must be clean before attaching labels to them.
 The bar codes must conform to the following criteria:

" Label positioning indications not  The position of the label on the tube
respected. must respect the following indications
(for a 75 mm high tube):

Legend:

1 15 mm min
2 60 mm max

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Troubleshooting

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REFERENCE MANUAL
Table of Contents

12 List of tubes ............................................... 1

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Table of Contents

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12
List of tubes

12 List of tubes
Characteristics of tubes for the STA Satellite® are the following ones:

Height 75 mm

External diameter 13 mm

Internal diameter (min.) 8.5 mm

If any other type of tube is used, compatibility tests must be performed. These tests must be
compliant with the protocol provided on request by Diagnostica Stago. The user assumes
all responsibility for the tests and the results.

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List of tubes

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Table of Contents

13 Maintenance schedule (tabular form) ..................... 1

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13
Maintenance schedule (tabular form)

13 Maintenance schedule (tabular form)

Please, keep this schedule up to date in order to maintain your STA Satellite® in a good
working order.

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Maintenance schedule (tabular form)

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STA Satellite N°: MAINTENANCE PREVENTIVE SCHEDULE YEAR: ________

Date of bringing into service:


Follow the maintenance according to the procedures described in the STA Satellite® reference manual

MAINTENANCE WEEKLY
Week Number 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26

Cleaning of the needle and the


washing well

Cleaning of the shield

Cleaning the carousels

Cleaning the sample and


product compartments

Cleaning of the rail glass

Cleaning of the rail, sample and


product hoods and of the
needle passage

Cleaning of the monitor

Cleaning of the rail

Cleaning of the optical sensor

Cleaning of the covering

MAINTENANCE YEARLY

Replacement of the needle

* Weekly maintenance: Date number + User's initials in the relevant box


* Yearly maintenance: Complete date + User's initials in the relevant box

Page : 1/2
Keep this document with the STA Satellite® reference manual
STA Satellite N°: MAINTENANCE PREVENTIVE SCHEDULE YEAR: ________

Date of bringing into service:


Follow the maintenance according to the procedures described in the STA Satellite® reference manual

MAINTENANCE WEEKLY
Week Number 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52

Cleaning of the needle and the


washing well

Cleaning of the shield

Cleaning the carousels

Cleaning the sample and product


compartments

Cleaning of the rail glass

Cleaning of the rail, sample and


product hoods and of the needle
passage

Cleaning of the monitor

Cleaning of the rail

Cleaning of the optical sensor

Cleaning of the covering

MAINTENANCE YEARLY

Replacement of the needle

* Weekly maintenance: Date number + User's initials in the relevant box


* Yearly maintenance: Complete date + User's initials in the relevant box

Page : 2/2
Keep this document with the STA Satellite® reference manual
REFERENCE MANUAL
INDEX

Access codes. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-5


Adjustment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-43, 4-44
Air filters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-34
Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-20
Alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-25, 5-43, 8-11
Alarm sound . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-13
See also Error message . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-15
Arbitrary unit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-12, 5-24
ASTM
Communication parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-15
Communication protocol . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-14
Host computer communications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-74
Automatic identification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-12, 6-14, 6-36–6-39
Automatic rerun . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-10

Barcode
Barcode reader . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-74–4-76
Reading problem . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-14
Barcode reader (See Barcode)

Calculated test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-43, 5-44


Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-10
Calibration (Calibrator) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-1–7-46, 10-7
General principles. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-13, 7-14, 7-15, 7-38
Interpolation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-39
Calibration (Calibrators). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-19
Calibration curve . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-5
Carousels
Product carousel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-7, 2-8, 2-10, 2-12
Sample carousel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-7, 2-10, 2-12
Chronometry. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-7
Cleaning of the needle and of the washing well. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-2
Clot . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3, 5-9
Color code(See Patient files)
REFERENCE MANUAL
INDEX

Colorimetry. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-4
Communication(See ASTM)
Controls of the day . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-6
Cuvette bin . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-10, 3-1
Change of disposable bin . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-13
Cleaning of the cuvette bin. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-21
Installation of the disposable cuvette bin . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-14
Cuvette roll . . . . . . . . . . . . . . . . . . . . . . . . 2-9, 2-10, 2-13, 3-7, 3-8, 3-9, 3-10, 3-11, 3-12
Cuvette roll loading
Cuvette roll . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-7–3-14
Cuvettes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-9, 2-13
Cuvette roll loading . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-7–3-14
CV (Coefficient of variation) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-1

Daily means . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-8


Date
Date format definition . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-17
Date format modification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-22
Dates
Dates of recent maintenance. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-55
Decontamination
Decontamination procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-8, 4-49
Decontamination solution. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-49
Decontamination solution. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-49
Dependent test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-26, 5-37
Determination . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-12, 5-21
Dilution. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-4, 5-10, 5-14, 5-20
Disposable cuvette bin (See Cuvette bin)

Emergency
Emergency sample loading. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-39
Error . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-5, 3-22, 4-64, 4-76, 5-10, 7-29, 8-9, 8-25, 11-2
Error message . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-10
Error window description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-1
Problem with the test run . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-12
REFERENCE MANUAL
INDEX

Problems regarding cuvettes. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-13


Problems regarding tube reading . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-14
Error messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-64, 4-76–4-78

File acquisition (See Patient files)


Fixation wheels. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-39
Fuses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-11
Fuse replacement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-46
Main fuses replacement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-47

Global options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-11–10-26

Head protection (localization) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-37


Host computer communications (See also ASTM) . . . . . . . . . . . . . . . . . . . . . . . . . . 4-74

Incubation
Incubation methods . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-5
Incubation measurement block. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-9
INR . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-12, 7-45
Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1
ISI . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-10, 7-38, 7-45

Kinetic 2 points. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-82, 5-9, 5-10


Kinetic OD/minute . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-9

Level detection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-2, 10-3, 10-4


Loading
Emergency sample . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-39
Generalities. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-1
Product loading. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-8
Products . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-6–6-20
Sample loading . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-7
Samples. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-20–6-39
REFERENCE MANUAL
INDEX

Washing solution . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-14–3-21

Main test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-1–5-26, 5-36


Maintenance
Decontamination. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-49
Preventive maintenance schedule. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1
Maintenance utilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-50–4-95
Manual identification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-14–6-19
Mapping (See Adjustment)
Microcontainer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-12
Monthly means . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-8

Needle kit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-35


Non read tubes (Manual identification) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-14
Notes. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-19

OD/Minute kinetic . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-82


Offset corrector. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-21
Offset modification. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-9–7-13, 7-40, 7-42
Optical density . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-4, 2-6

Patient file
STAT sample . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-28
Patient files . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-1
Color code signification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-4
Deleting old files . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-2
Emergency patient file . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-13
File acquisition . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-16
Note . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-18
Routine use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-1–8-54
Standard note . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-19
Photometry
Colorimetry. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-4, 2-7
Immunology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-4, 2-7
REFERENCE MANUAL
INDEX

Primary unit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-12, 5-24


Product stability . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-9
Product status . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-8
Product unloading. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-41–6-44

QNS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-5, 8-11


Quality control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-1–9-23, 10-7
Control of the day . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-7, 9-23
Controls of the day . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-19
Level of quality control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-2
Screen description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-3–9-9
Quantity of plasma not sufficient(See QNS)

Reference time . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-8, 7-14, 7-20


Repeatability. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-14
Rereading . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-64, 4-67, 4-68
Results
Display of the results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-4
Graphics display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-80–4-85
Result status . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-10, 8-33
Result transmission. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-19
Results transmission . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-23–5-26
Saving (TDEX). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-72
Unit options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-12

Sample unloading . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-45–6-47


Saving . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-64
Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-26
Screens
Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-1–10-26
Standard deviation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-1
Stirring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-11, 6-6
stirring. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-4
Stop of the analyzer
Extended stop . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-8
REFERENCE MANUAL
INDEX

Power-off procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-22


Sums monthly. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-6

TDEX . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-72, 4-73


Test panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-3
Test profile(See Tests)
Test setup
Dependent test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-26, 5-37
Dependent tests. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-28
Main test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-36
Test setup parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-28–5-35
Test setup parameters
Main test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-1–5-35
Tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-40–5-43, ??–5-43
Test download from Host computer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-34
Test list . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-3
Test profile . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-24–6-27
Tightening key . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-39
Transmission(See Results)
Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-1–11-15
Tubing connection (localization) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-38

Units . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-12

Warnings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2, 1-3, 1-5


Washing solution
Rinsing solution (See Loading)
Working file . . . . . . . . . . . . . . . . . . . . . 8-1, 8-2, 8-3, 8-4, 8-5, 8-7, 8-8, 8-33, 8-35, 8-37
Working list . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-54

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