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STA Satellite
STA Satellite
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.
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
REVISION TABLE
2 Introduction
4 Maintenance
5 Test setup
7 Calibration
9 Quality Control
10 Miscellaneous screens
11 Troubleshooting
12 List of tubes
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1.1 Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
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Symbols and warnings
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
On disposable items
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In the documentation
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- 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.
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.
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.
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.
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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).
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 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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Make sure that you connect the waste container tubing (red tubing) on the connection port
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.
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.
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" 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)
Before switching the analyzer back on, put the liquid waste container and the cuvette roll
back in place, then, follow the same decontamination procedure.
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
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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
Power supply:
Frequency 50/60 Hz
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Screen (optional)
Keyboard (optional)
Printer (optional)
Serial port
(connection to host computer)
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Introduction
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.
Légende :
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Introduction
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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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
A=εIC
A = Absorbance
e = Molecular exctinction coefficient
I = Optical path length
C = Concentration
Chromophore concentration measured is proportional to the absorbance.
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Introduction
After centrifugation, primary tubes are open and loaded into the sample carousel. Their
location is identified by the Positive Identification system.
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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.
Any product required for testing must be loaded into the product carousel. Their location is
identified by the Positive Identification system.
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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Introduction
When the STA Satellite is on, do not put your fingers inside the carousel except when
the analyzer is on loading or unloading mode.
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Introduction
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
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
Space requirements:
• Height: 794 mm (31.3 in.)
• Width: 800 mm (31.5 in.)
• Depth: 900 mm (35.4 in.)
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All devices connected to the STA Satellite must comply with CEI 60950, EN 55022 class B
and EN 55024 standards.
• 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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Introduction
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
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:
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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Check that nothing obstructs the ventilation, especially the areas above the screen and
beneath the analyzer.
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:
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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
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:
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ACTIONS RESULTS
" Press the Enter key The Product loading menu is displayed
" Initiate product loading (see chap. 6.3) TEST STATUS window is diplayed
It is also the return point menu from all other STA Satellite menus.
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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)
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
6 Primary unit for obtained results defined in the test setup (see chap. 5.1.1.7)
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"− − −.−" 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 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)
"> 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
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:
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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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)
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
3.4.1.2 Accessing CUVETTE ROLL CHANGE window from the TEST PANEL
2 TEST PANEL SCREEN displayed.
ACTIONS RESULTS
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ACTIONS RESULTS
" 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
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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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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Legend:
1 Axis
Legend:
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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.
" Take out the disposable bin by pulling it up (see fig. 6).
" 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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Legend:
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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
3.6.1.2 Accessing the WASHING SOLUTION LOADING window from the TEST PANEL
2 TEST PANEL screen is displayed.
ACTIONS RESULTS
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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
" 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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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
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.
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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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.
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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3.7.1 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).
ACTIONS RESULTS
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Preparation of the STA Satellite
ACTIONS RESULTS
" 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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Table of Contents
4 Maintenance .............................................. 1
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4 Maintenance
4.1 Preventive maintenance schedule
This schedule is given as an example, it must be adapted to the laboratory activity.
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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..
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Maintenance
ACTIONS RESULTS
" Press the Enter key to access the The following menu is displayed:
Maintenance Menu
Press the Enter key to access the The Rinsing and Purge menu is
Rinsing and purge menu displayed:
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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
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Maintenance
ACTIONS RESULTS
" 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
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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
Legend:
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" 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).
Legend:
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Maintenance
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.
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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.
" 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.
" Replace the cuvette roll on its support after checking the cuvette strip.
Fig. 5 - Rail
Legend:
1 Electronic card
2 Rail cover
3 Rail
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Maintenance
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.
" 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).
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Maintenance
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.
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 ).
Legend:
1 Lowest part of the needle protection (it must point towards the back side of the analyzer)
" 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.
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" With the help of this tool, remove the front filter.
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Maintenance
" 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).
" 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).
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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.
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Maintenance
RISK OF INJURY
RISK OF BIOLOGICAL CONTAMINATION
Never introduce your hand or part of your hand in this area when the machine is ON.
" 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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Maintenance
" 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).
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Maintenance
" 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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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.
" Press the Esc key (Continue) in order to quit the error message.
The following message is displayed:
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Maintenance
Legend:
1 Product glass
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To carry out this procedure, the bottle plate must be positioned as indicated on the
fig. 19.
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Maintenance
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:
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:
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13 Run purges until the fluidic circuit is empty (display of an error message indicating that
the solution is missing).
17 Place the container filled with the decontamination solution at the STA Cleaner
Solution location in the bottle plate (see fig. 19 - mark 2).
22 Repeat the action described above (circuit fluidic purge - step 12) until half of the
decontamination solution is used.
At this step, leave the empty container having received the decontamination solution in the
bottle plate.
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Maintenance
30 Press the Del key to access User Maintenance menu (see chap. 4.9.1).
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).
38 Place the cap identified in blue on the STA Cleaner Solution container.
42 Carry out the circuit fluidic purge as many time as necessary to empty half of the
STA Cleaner Solution container.
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).
47 Call your local authorized Service Representative if the quality controls are still out of
range.
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Legend:
1 Upper part
2 Filter
3 Lower part
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Maintenance
Legend:
2 Tube
3 Needle
ACTIONS RESULTS
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ACTIONS RESULTS
" Press the Enter key to access the The following menu is displayed:
Maintenance menu
" 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
Before removing the needle, eliminate the electrostatic charging by touching a metal
part of the STA Satellite (e.g. pole, frame,...)
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" 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.
Legend:
2 J2 connector
3 Fixation wheels
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Maintenance
Legend:
Make sure you do not pinch the tube (see fig. 23).
" Rotate the arm and make sure the needle goes through the prongs of the optical
measurement area (see fig. 9).
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" 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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Maintenance
ACTIONS RESULTS
" Remove the rail cover (see fig. 5) The following window is displayed:
" Then press F10 to confirm
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Legend:
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
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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Maintenance
Legend:
1 Mapping hole
2 Needle
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ACTIONS RESULTS
" 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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Maintenance
ACTIONS RESULTS
" 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
" 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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Maintenance
It is mandatory to:
go through the Needle replacement menu to replace the needle.
run quality controls (PT, APTT and FIB) to validate the needle replacement procedure.
RISK OF ELECTROCUTION
The analyzer must be turned off during this operation.
Legend:
1 F1 fuse
2 F2 fuse
3 F3 fuse
4 F4 fuse
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Maintenance
5 F5 fuse
6 Main fuses
Fuses are located on the right panel of the STA Satellite , under the printer (see Fig. 28).
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.
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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" Take a thermal paper refill and cut the paper in order to obtain a straight edge, as shown
on the drawing below:
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Maintenance
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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ACTIONS RESULTS
" 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
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Maintenance
ACTIONS RESULTS
" Press the DEL key to access the User The User Maintenance menu is
Maintenance menu displayed:
4.9.2 Maintenance
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" Press the Enter key to access the The following menu is displayed:
Maintenance menu
" Press the Enter key to access the The following menu is displayed:
Rinsing and Purge menu
" 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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Maintenance
" Press the Enter key to confirm The following menu is displayed:
" 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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ACTIONS RESULTS
" Press the until you reach Return to The User Maintenance menu is
previous menu, then press the Enter displayed
key
" Press the key until you reach Printer, The Printer menu is displayed:
then press the Enter key to confirm
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Maintenance
ACTIONS RESULTS
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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
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
" Press the Esc key to return to the The Printer menu is displayed
Printer menu
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Maintenance
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
ACTIONS RESULTS
" Press simultaneously the Symb key The whole screen display is printed
and the I key to print the screen display
" Press the Esc key to return to the The Printer menu is displayed
previous menu
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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
" Press the Enter key to access the The following message is displayed:
menu "printer connected"
Return to Test of the external printer
menu
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Maintenance
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
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
" 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
ACTIONS RESULTS
" Press simultaneously the Symb key The whole screen display is printed
and the I key to print the screen display
" Press the Esc key to return to the The Printer menu is displayed on the
previous menu monitor
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Maintenance
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
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4.9.5 Saving
This program allows to save or to load the following parameters:
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.
SAVING LOADING
Error Messages Only for your local authorized Only for your local
Service Representative. authorized Service
Representative.
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Maintenance
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
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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:
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Maintenance
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).
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 ?
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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 !
" 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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Maintenance
4.9.5.4 Saving
Prior: Select the items to be saved (see chap. 4.9.5.2).
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 ?
" 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 !
" 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
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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 %
/__/__/__/__/__/
Advance %
/__/__/__/__/__/
Saving OK
Formatting will erase all data (all files) on the floppy disk. This operation allows you to use
the floppy disk again with full capacity.
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.
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Maintenance
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 %
/__/__/__/__/__/
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
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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
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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Maintenance
ACTIONS RESULTS
" Press the F10 key to transfer data The following window is displayed
TRANSFER IN PROGRESS....
" Press the Esc key to quit The following window is displayed:
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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:
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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Legend:
2 Display of the barcode read after scanning of the barcode label in front of the reader
" 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
ACTIONS RESULTS
" Press the Esc key to quit The following window is displayed:
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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)
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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
To avoid computer viruses, use the floppy disks provided by Diagnostica Stago only with
the STA Satellite .
Software update
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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)
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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
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
Legend:
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)
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
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.
9 Calculation window
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
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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
ACTIONS RESULTS
ACTIONS RESULTS
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ACTIONS RESULTS
" 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
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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ACTIONS RESULTS
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
4.9.13.1 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.
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 .
- 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)
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Level 3
Calibration - Modification of a 100 % point
(see chap. 7.5.1)
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ACTIONS RESULTS
" Press the key until reaching Users The following window is displayed:
Management
" Press the Enter key to confirm
Legend:
F4 Adding a user
2 Screen name
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5 Administrator name
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:
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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:
ACTIONS RESULTS
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ACTIONS RESULTS
" Press the key until reaching System The following window is displayed:
date and time
" Confirm using the Enter key
" 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:
" 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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RESULTS
" Press the key until reaching System The following menu is displayed:
date and time
" Confirm using the Enter key
" 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 :
" 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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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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Test setup
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).
Legend:
1 Available functions:
3 Test identification
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1 / 6
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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
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Clotting
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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.)
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5.1.1.7 Results
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M1 - M 2
Precision = M
x 100
5.1.1.8 Validation
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Redilution options must be handled with great care because they are not always
compatible with the measurement principle.
The rediluted result will only be given in the primary unit (use of secondary units is not
allowable in this case).
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Legend:
1 Available functions:
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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)
These parameters are only available for graphic calibration modes (linear, 2nd order
polynom, 3rd order polynom or hyperbolic).
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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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CALIBRATOR DILUTION
ID. Name
CALIBRATOR DILUTION
ID. Name
These parameters are only available for graphic calibration modes (linear, 2nd order
polynom, 3rd order polynom or hyperbolic) and bar-coded calibration mode
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Test setup
This parameter is only available for graphic calibration modes (linear, 2nd order polynom,
3rd order polynom or hyperbolic).
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.
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The following parameters apply to all measurement methods and all calibration modes.
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Legend:
1 Available functions:
Esc Display of the EXIT OPTIONS window (see description in chap. 5.3.2).
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Legend:
1 Available functions:
Esc Display of the EXIT OPTIONS window (see description in chap. 5.3.2)
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ACTIONS RESULTS
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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:
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
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" 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.
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ACTIONS RESULTS
If you press Esc by mistake, press Esc again To cancel the exit from setup screens.
2 TEST SETUP screen, cursor on the first test (see chap. 5.2.1).
ACTIONS RESULTS
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ACTIONS RESULTS
This access is only available from page 1 of 3 of the main test setup.
ACTIONS RESULTS
" Press until you reach the desired Cursor on the first modifiable parameter.
dependent test and confirm with Enter.
ACTIONS RESULTS
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2 types of parameter:
Free entry field: the parameter and the cursor are displayed in blue.
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.
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ACTIONS RESULTS
" 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
" From the TEST SETUP screen, press A message advising the operator to
Esc and confirm with Enter. proceed to test setup saving is displayed
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" 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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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 the key until you reach the test The following window is displayed:
to be moved, then confirm with Enter.
" 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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Test setup
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.
" Press Esc to delete the last message. The TEST SETUP screen is displayed.
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.
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2 TEST SETUP screen, cursor on the first test (see chap. 5.2.1).
ACTIONS RESULTS
" Type login and password The UPDATE TRACK RECORD screen is
(see chap. 4.9.13.5). displayed with the following window:
" Validate with Enter.
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ACTIONS RESULTS
" 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.
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ACTIONS RESULTS
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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Legend:
1 Esc Display of the EXIT OPTIONS window (see description in chap. 5.3.2)
F6 Print out of the screen
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The unit is implicit according to the type of calculation selected, see chap. 5.8.1.
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6.1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
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Product and sample loading
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.
This message is displayed with «beep» sounds to warn the user that the STA Satellite® is
now ready for loading.
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Legend:
2 Available functions:
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Product and sample loading
(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.
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.
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).
12 Information on the Normal Vol. or microvolume according to the option selected (F8).
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Product and sample loading
Legend:
1 Screen name
2 Available functions:
Esc Options: This key opens the following window:
Change profile(s): creates or modifies test profiles (see description in chap. 6.4.3).
- 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.
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.
- 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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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.
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.
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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Product and sample loading
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 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
" 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
The Enter key enables the display of the vials saved during the last use of the STA
Satellite® (see procedure described below):
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Product and sample loading
" 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).
Never remove the product carousel from its location to process to a single vial loading.
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
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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
" 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
" Proceed to vial loading The STA Satellite® reads the barcode of
the
newly installed vial.
" Press Enter to confirm the name The name is confirmed and the cursor
moves to volume
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Product and sample loading
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:
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ACTIONS RESULTS
" 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
" 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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Product and sample loading
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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Product and sample loading
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)
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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Product and sample loading
ACTIONS RESULTS
" 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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Product and sample loading
ACTIONS RESULTS
" If necessary, enter the lot number and For all reagents that do not belong to the
confirm by pressing Enter STA product line from Diagnostica
Stago, the following window is displayed:
" 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)
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Product and sample loading
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
" 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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Product and sample loading
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:
" Type YES, then confirm by pressing The following window is displayed:
Enter
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Product and sample loading
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
" 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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Product and sample loading
ACTIONS RESULTS
" 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
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Product and sample loading
Samples must be stored outside the STA Satellite® as soon as their presence is no
longer necessary inside the analyzer.
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
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ACTIONS RESULTS
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
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Product and sample loading
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
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TEST SELECTION
Manual X X X X
with prefix
IDENTIF. Manual X X X X
without 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.
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Product and sample loading
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).
Legend:
1 Screen name
2 Profile list
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ACTIONS RESULTS
" Press Esc (Options) For the MANUAL mode, the following
window is displayed:
" 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
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Product and sample loading
ACTIONS RESULTS
" Press Esc (Options) For the MANUAL mode, the following
window is displayed:
" 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
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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.
ACTIONS RESULTS
" 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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Product and sample loading
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)
2The SAMPLE LOADING screen is displayed with AUTO MODE displayed (as described in
chap. 6.2.2).
ACTIONS RESULTS
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ACTIONS RESULTS
" 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
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)
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Product and sample loading
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)
DUPONT DUPONT1
100 101
MAT100 MAT101
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Product and sample loading
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
" 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)
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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Product and sample loading
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)
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)
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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Product and sample loading
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)
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
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Product and sample loading
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
Legend:
" 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
F10 = Confirm
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Product and sample loading
2The SAMPLE LOADING screen is displayed with MANUAL MODE displayed (as described in
chap. 6.2.2).
ACTIONS RESULTS
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Product and sample loading
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
" 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
Product and sample loading
ACTIONS RESULTS
" 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
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Product and sample loading
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.
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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6
Product and sample loading
ACTIONS RESULTS
" 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
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Product and sample loading
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
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
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6
Product and sample loading
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
" 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
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Product and sample loading
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 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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6
Product and sample loading
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
YES
NO
with the cursor on YES
" Close the safety cover The TEST STATUS screen is displayed.
" Press any key
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Product and sample loading
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
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6
Product and sample loading
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
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
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Product and sample loading
ACTIONS RESULTS
" Remove the tube from the carousel Data from the unloaded tube are
removed from the SAMPLE LOADING
screen.
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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6
Product and sample loading
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
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Product and sample loading
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 sample pipettings have been blocked, The following window is displayed:
press Esc
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Table of Contents
7 Calibration ................................................ 1
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Table of Contents
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7
Calibration
7 Calibration
7.1 Access to a given calibration
ACTIONS RESULTS
" 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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Calibration
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)
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Calibration
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Calibration
Legend:
1 Screen name
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)
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7
Calibration
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)
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).
Legend:
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Calibration
Legend:
- 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)
4 Date and time of the calibration control validation, if they are used.
If not, the box is empty.
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Calibration
13 Lot number corresponding to each reagent used during calibration. The box is empty if
the reagent has no lot number
Legend:
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Calibration
- 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)
4 Date and time of the calibration control validation, if they are used.
If not, the box is empty.
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Calibration
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Calibration
Legend:
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Calibration
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)
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)
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Calibration
10 Standard values after interpolation from the equation found for the calibration curve
(expressed in the primary result unit)
13 Regression coefficient
Legend:
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7
Calibration
6 Dilution ratio for each calibrator, defined in the test setup menu (see chap. 5.1.2.3)
16 Identification number, complete name and lot number of the offset corrector plasma.
For clotting tests, this zone remains empty
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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Calibration
Mode Calibrate
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).
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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Calibration
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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Calibration
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).
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7
Calibration
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).
ACTIONS RESULTS
" 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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Calibration
ACTIONS RESULTS
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.
ACTIONS RESULTS
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Calibration
ACTIONS RESULTS
" 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.
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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
" Identify yourself (see chap. 4.9.13.5). The following window is displayed:
" 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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7
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.
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Calibration
7.3.5.2 Running and validation of a ratio mode calibration without calibration controls
ACTIONS RESULTS
" Identify yourself (see chap. 4.9.13.5). The following window is displayed:
" 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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7
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
ACTIONS RESULTS
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Calibration
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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Calibration
ACTIONS RESULTS
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Calibration
7.3.6.2 Running and validation of graphic mode calibrations without calibration control
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 concentration for the
first standard (see description of this
screen in chap. 7.2.4, zone 20 ).
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7
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.
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. .
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Calibration
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).
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7
Calibration
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.
- 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
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Calibration
7.4.2.1 Description of the Calibration not confirmed window (out of range controls)
Legend:
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
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
Calibration
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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Calibration
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).
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
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7
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.
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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Calibration
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
" 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.
" 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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Calibration
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).
This procedure is only available if the calibration was performed with the same reagent
sets as the ones used previously.
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Calibration
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).
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
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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.
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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Calibration
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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Calibration
ACTIONS RESULTS
" Type the access code then confirm The following window is displayed:
using Enter
" 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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Calibration
ACTIONS RESULTS
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7
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.
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Calibration
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:
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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.
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Calibration
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
" When the printout is complete, press The Printout window is removed.
Esc Return to selected calibration screen.
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Calibration
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:
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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).
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
8.1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
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Table of Contents
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Table of Contents
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Table of Contents
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Patient file management
This menu gives access to the Patient files of the Working File.
ACTIONS RESULTS
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ACTIONS RESULTS
Legend:
Opens the file on which the cursor is positioned (see chap. 8.3)
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Patient file management
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.
- 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)
ACTIONS RESULTS
" 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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Legend:
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
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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Patient file management
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).
" 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 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).
ACTIONS RESULTS
" 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).
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Patient file management
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).
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Legend:
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.
5 File status
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Patient file management
6 File identification
7 Test list from the file. An asterisk (*) will be displayed on the left of the tests with alarm(s)
(see point 12 below).
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
- 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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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 :
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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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).
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.
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).
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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.
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).
OK V<Vmin Err
OK V>Vmax Err
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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).
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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Patient file management
ACTIONS RESULTS
" 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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ACTIONS RESULTS
" 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.
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.
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Patient file management
ACTIONS RESULTS
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ACTIONS RESULTS
Legend:
- Transmitting only files that have never been transmitted (option displayed by default)
- Transmitting all files, including files that have already been transmitted
F10 Runs patient file transmission (or starts it again if it has been stopped)
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Patient file management
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).
" 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.
8.5.1 Generalities
There are three file printout options:
Online printout: Patient files are printed file by file as soon as they are complete (see
description in chap. 8.5.8).
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).
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).
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).
ACTIONS RESULTS
" 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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Patient file management
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.
If Patient files are printed on the internal printer, there is no printout setup to define (see
printout examples in chapter below).
Legend:
1 Name of the laboratory, as defined in the Global Options menu (see chap. 10.2.2.2).
4 Complete test name, preceded by an asterisk (*) if the test has one or several alarms.
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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).
Legend:
1 Screen name.
2 Test abbreviations.
3 Control names.
7 Result status:
- Validated,
- Forced,
- Out Range,
- In progress,
- Error.
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Patient file management
ACTIONS RESULTS
Legend:
1 Prints only the unprinted files from a Patient file selection (see procedure in chap.
8.5.9).
3 Define printout parameters for the external printer (see procedure in chap. 8.5.6 and
8.5.7).
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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
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Patient file management
• 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).
2The Printout window is displayed with the cursor on (see chap. 8.5.4).
ACTIONS RESULTS
" 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.
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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.).
ACTIONS RESULTS
" 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
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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Patient file management
2The Printout window is displayed (see procedure in chap. 8.5.4) with the cursor on
.
ACTIONS RESULTS
" 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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Patient file management
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).
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.
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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).
12 Page number. In "Single file" mode, the page number starts at 1 for each 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 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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Patient file management
ACTIONS RESULTS
" 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
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Legend:
3 Prefix identification
By default, all the options are set to YES (colored square displayed).
F10 Displays the list of selected files, and allows its deletion,
" 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).
ACTIONS RESULTS
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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).
ACTIONS RESULTS
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Legend:
1 F1 Change: opens a window which allows to choose the type of file modification to
apply:
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
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Applies file modification chosen (or cancels it) for 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.
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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ACTIONS RESULTS
" 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.
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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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Patient file management
ACTIONS RESULTS
" 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
" 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.
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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.
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Patient file management
ACTIONS RESULTS
Legend:
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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.
Customer printout setup is only available if the operator decides to print files on the external
printer.
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Patient file management
To determine the length of the Patient file, the Customer printout menu uses the Page
T
o
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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.
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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Patient file management
ACTIONS RESULTS
" 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).
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Legend:
Moves the cursor to the next line ( key) or to the previous line ( key)
Note: General data name n°1, n°2 and n°5 must be entered.
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Patient file management
Legend:
Moves the cursor to the next line ( key) or to the previous line ( key)
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3 Constant remark:
2 lines of 60 characters printed on one line in a condensed format.
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.
ACTIONS RESULTS
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Patient file management
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
Legend:
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
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ACTIONS RESULTS
" 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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Patient file management
ACTIONS RESULTS
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Table of Contents
9.1 Generalities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
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Quality Control
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).
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.
i=n
∑ xi
Mean: i=1 -
m = ------------- xi = result in primary unit
n
Standard deviation:
Coefficient of variation:
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Zone n
Sums Daily 1 to 31
Sums Monthly 1 to 12
ACTIONS RESULTS
" 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).
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Quality Control
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
Legend:
3 List of the test abbreviations with a colored square of the abbreviation showing the
quality control status (see point 5 below).
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.
Legend:
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Quality Control
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.
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.
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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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Quality Control
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.
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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.
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.
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Quality Control
For the month when the lot was changed, the mean displayed is the one with the most
representative number of points.
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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Control run in single Outside the defined range Control rerun in duplicate
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.
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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Quality Control
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).
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).
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
" 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:
" 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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Quality Control
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.
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
" 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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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.
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Quality Control
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
Legend:
1 Test abbreviation
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4 Recall of the acceptance range for the quality control (in primary unit)
7 Available functions:
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
" 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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Quality Control
ACTIONS RESULTS
" Press Esc then press Enter Return to QUALITY CONTROL screen (Test
list).
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
" 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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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 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
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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Quality Control
2 The quality control result screen (graphic mode) is displayed for a given level (see
access in chap. 9.2).
ACTIONS RESULTS
" 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
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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.
2Quality control result screen (graphic mode) is displayed for a given level (see access in
chap. 9.2).
ACTIONS RESULTS
" 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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Quality Control
ACTIONS RESULTS
" Press Esc then confirm by pressing Return to QUALITY CONTROL screen (Test
Enter list).
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
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ACTIONS RESULTS
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
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Quality Control
ACTIONS RESULTS
ACTIONS RESULTS
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Legend:
3 Test abreviation
4 Control name
7 Acceptance range
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Quality Control
ACTIONS RESULTS
" 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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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.
ACTIONS RESULTS
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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.
3 Screen name.
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Miscellaneous screens
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".
6 Running mode
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.
9 Software version.
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" 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.
ACTIONS RESULTS
" 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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10
Miscellaneous screens
If the level detection is deactivated, a message is displayed when the sample carousel or
product carousel opens.
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.
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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Miscellaneous screens
Legend:
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.
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.
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10
Miscellaneous screens
In case of negative margins, zones 9 (Identification) and 10 (Name) are also displayed in
red.
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.
12 Calibration status:
- Not done
- In progress
- Control out (out of range control)
- To be validated
- Validated
- 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.
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Miscellaneous screens
Legend:
3 Screen name
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Miscellaneous screens
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:
The display color of the stability end and of the alphanumerical identification depend on the
following conditions:
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Miscellaneous screens
10.1.5 Options
New printout requests are impossible as long as there are printouts in progress.
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Miscellaneous screens
ACTIONS RESULTS
" 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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Miscellaneous screens
Legend:
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.
4 Printout parameters.
7 Miscellaneous section.
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Miscellaneous screens
10.2.2.2 Printout
Identification of the laboratory as it appears on the result printout.
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
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Miscellaneous screens
Legend:
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.
5 Miscellaneous section:
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Miscellaneous screens
10.2.3.2 Communications
The following parameters are used to define the characteristics required for transmission to
the host computer (ASTM protocol) :
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Miscellaneous screens
ID type:
There are two options:
- Numerical
- Alphanumerical
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10
Miscellaneous screens
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.
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Miscellaneous screens
10.2.4.1 Generalities
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.
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.
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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Miscellaneous screens
ACTIONS RESULTS
" When the desired option is displayed, The selected option is displayed.
press Enter
The cursor moves to the next parameter.
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Miscellaneous screens
ACTIONS RESULTS
Separator selection
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
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
Format: 0 - 12 h
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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Miscellaneous screens
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
ACTIONS RESULTS
Separator selection
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.
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.
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Miscellaneous screens
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.
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10
Miscellaneous screens
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.
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ACTIONS RESULTS
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Table of Contents
11 Troubleshooting .......................................... 1
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Table of Contents
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11
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.
Legend:
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
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Troubleshooting
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Troubleshooting
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Troubleshooting
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11
Troubleshooting
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Troubleshooting
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Troubleshooting
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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.
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Troubleshooting
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
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.
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Troubleshooting
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11
Troubleshooting
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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Table of Contents
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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
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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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: ________
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
MAINTENANCE YEARLY
Page : 1/2
Keep this document with the STA Satellite® reference manual
STA Satellite N°: MAINTENANCE PREVENTIVE SCHEDULE YEAR: ________
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
MAINTENANCE YEARLY
Page : 2/2
Keep this document with the STA Satellite® reference manual
REFERENCE MANUAL
INDEX
Barcode
Barcode reader . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-74–4-76
Reading problem . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-14
Barcode reader (See Barcode)
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
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
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
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
Units . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-12