0931272C - December 2010

REF. 39632

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User’s Guide
 Recommendations
This User’s Guide is an informational document which can be used as an aide (IV) In case of use of washed and/or re-use cuvettes, the reacting cuvettes
for the use of the system. being consumables intended for a single use, as well as cuvettes other than
those manufactured by Diagnostica Stago and commercialised by Diagnostica
In order to ensure the correct operation of the system, it is imperative to
Stago and/or by its official distributors,
acknowledge and to comply with any and all of the information, warnings,
instructions and procedures contained in the Reference Manual of the analyzer, (V) In case of non accomplishment of the current or regular maintenance
and in particular to respect the following recommendations: operations, calibration and support operations set forth in the Reference Manual
and permanently required to ensure the correct functionning and security of the
- The use of the system requires training provided either by Diagnostica Stago
system,
or by one of its official distributors.
(VI) In case the system is not decontaminated in accordance with the
- The compliance with any and all local legislations, regulations and norms
decontamination procedures set forth in the Reference Manual.
related to biological acts and/or to medical biology laboratories applicable in the
territory where the system is installed is required and in particular for France,
the GBEA (Guide to Correct Performance of Medical Biology Analyses)
published in its most recent version in the decree of April 26th 2002 (JO Information contained in this document, in particular data, pictures,
[Journal Officel] May 4ths 2002 n° 104), and for the United States, the CLIA-88 information, trademarks and logos are protected by copyrights and other
in the most recent version (Clinical Laboratory Improvement Act of 1988). intellectual property rights
Under no circumstances shall Diagnostica Stago, its employees, its suppliers or ©2007, Diagnostica Stago, all rights reserved - 12/2010.
a third party mentioned in this User’s Guide be liable whether in contract, tort Consequently, all representation and/or reproduction, whether in part or in
including, but not limited to negligence or otherwise for any special or full, is forbidden and would be considered a violation of Diagnostica Stago’s
consequential damages or losses that result from the security and the efficacy copyrights and other intellectual property rights.
of the system as well as any damage whatever, direct, indirect, material or
immaterial, incidental or accessory, or of any nature whatever or of any
prejudice, in the non restrictive cases listed hereunder:
(I) In case of non respect of the Recommendations described in this
User’s Guide and in the Reference Manual as well as the use of procedures
that are not set forth by Diagnostica Stago,
(II) In case of use of reagents other than those manufactured by Diagnostica
Stago even if the use of said reagents associated with the system is specified in
an adaptation protocol,
(III) In case of use of tubes other than those specifically listed in "List of tubes”
chapter of the Reference Manual,
 Preparing the Analyzer

Read the recommendations concerning the use of the STA Satellited in the Loading a cuvette roll
Reference Manual.
After changing the cuvette roll, the cuvette bin must systematically be emptied.
Before switching the STA Satellited on, make sure that
- the cuvette bin is placed in its location, The cuvette loading menu is accessible on request of:
- the needle head protection is in place, - the user,
- the rail cover is in place. - the STA Satellited when the cuvette roll is empty
(Follow the instructions displayed in the error message).
Checkings Test panel
Make sure that the STAd-Cleaner Solution bottle and the waste bottle are placed Press and then choose “(Un)Loading” or press
inside the bottle plate
Make sure the bottles are correctly connected (clear tube = STAd-Cleaner Loading
Solution, red tube = waste bottle)
Choose “Cuvettes”
Make sure that the bottle plate is on the left side and below the analyzer
Change the roll and confirm each step with
Make sure that nothing obstructs the air vents, especially the ones located above
the screen and below the analyzer Confirm the number of cuvettes with or modify this number and confirm again
with
Empty the cuvette bin and confirm with
Starting the analyzer
Loading the STAd-Cleaner Solution
Turn the analyzer on and wait until the data checking is complete
Use the “Washing Solution” option of the “(Un)Loading“ menu to load the
Check the system date and time and select “Continue” to confirm STAd-Cleaner Solution.
Prepare the reagents, quality controls and calibrators (if necessary) and let them
stabilize
Load the STAd-DESORB U
(See “Reagent Loading”)

Preparing
the
Analyzer
 Reagent Loading

Two products requiring stirring must not be placed side by side within the product Product loading
carousel. Open the product cover
If loading more than one product requiring stirring, either leave an empty position or Press any key (other than ALT and SYMB)
place a product that does not require stirring in between the two stirred products. Take the product carousel out and place it on a flat surface
Load vials in the carousel: the barcode label must face the reading zone.
Single product loading The vial must not prevent the closure of the cover
Put the carousel back in and close the cover
The STA Satellited detects the vials loaded in the carousel
When loading a single product, if the cover is open, do not move or remove the product
carousel. For each vial, check its volume and confirm with
If the volume has been modified, type the new volume and stability if necessary and
confirm with (See “Reagent Loading” ?)
Test panel
Press If a lot change is detected
Product loading Type YES and confirm with
Pass the barcode sheet included in the product box in front of the barcode reader
Open the product cover
Press
Press any key (other than ALT and SYMB)
Position the cursor on the line corresponding to the vial position (use the direction
arrow keys)
Products without barcode label (not from the STAd line)
Press Type the reagent identification (identity, name, volume, stability, lot number and
The analyzer places the selected position in front of the barcode reader window volume type) and confirm each option with
Put the vial in the presented position. The barcode label must face the barcode
reader window ? Test status
The STA Satellited detects the newly loaded vial The list of the reagents in the product carousel is displayed.
Check the volume of the vial and confirm with The MARGE column indicates the volumes (in ml) that are theorically available once the
If the volume has been modified, type the new volume and stability if necessary and requested tests are over.
confirm with Make sure the quantities of the remaining volumes are sufficient
Press Load the reagents that are displayed in red on the screen
Close the product cover Press
Press any key (other than ALT and SYMB) If none of the required reagents have been loaded or if their volume is not sufficient, the
(See “Reagent Loading” ?) following message is displayed:
New tests are delayed
Product carousel loading Reactivate now Y/N ?

Test panel Press to restart the test series

The tests for which reagent vials are missing or reagent volume is insufficient will
Press and then not be run
Press to load the missing reagent(s)

Reagent
Loading
 Control and Calibrator loading
The control and calibrator loading procedure is the same one as the reagent loading
procedure (see “Reagent Loading”).
The use of adapters is required to load controls and calibrators in the product carousel.

For non STAd line products, type the range of acceptable values in the “Quality
Control” menu and the calibrator values in the “Calibration” menu.

Control and
Calibrator
Loading
 Calibration
Load the reagents Quick running of several calibrations
(See “Reagent Loading”)
For each test to calibrate:
Load the controls and the calibrators
Position the cursor on the test to be calibrated
(See “Control and Calibrator Loading”)
Press to request calibration run for the test
Test panel When all tests have been selected:
Press Press to confirm
In the main menu, choose “Calib./Control” or press and then choose Type the login name and the access code and press to confirm
“Calibration” (Go to ?)

Calibration

Running a calibration
Position the cursor on the test to be calibrated
Press ? Press to quit the menu
Press to display the options
Test status
Choose “Calibrate” and confirm with
Type the login name and the access code and press to confirm Check the remaining quantity of reagent
Press to run the calibration or modify, if necessary, the parameters and Press to quit the menu
press
Press to return to the “Calibration” menu,
The square corresponding to the test to calibrate becomes yellow
Follow the same procedure as described previously to run other calibrations
(Go to ?)

Calibration
 Quality Control
Load the reagents Running one or several quality control levels
(See “Reagent Loading”)
Position the cursor on the test to control, press and then
Load all the quality control levels
Select “Run” and press to confirm
(See “Control and Calibrator Loading”)
Type the login name and the access code and press to confirm
Test panel To run another quality control level, press or and follow the same
procedure as described previously
Press
Press , select “Return to result list”, and then press to confirm
In the main menu, choose “Calib./Control” or press and then choose
“Quality Control” The square corresponding to the test to control becomes yellow
(Go to ?)
Quality control

Running all the quality control levels

For each test to run:
Position the cursor on the test to control
Press to run the test
When fall the tests have been selected:
? Press

Press to confirm Test status

Type the login name and the access code and press to confirm Check the remaining quantity of reagent
The square corresponding to the test to control becomes yellow
Press to quit the menu
(Go to ?)

Quality
Control
 Sample loading
Samples can be loaded: Single sample loading (closed cover loading)
- with an open cover (recommended for loading several samples at the same time)
If the sample has been transferred into a microcontainer, press before following
- with a closed cover (for loading samples one by one)
the procedure described below
Test pael Put the sample into the carousel through the hole located in the cover
The barcode label must face the barcode reader window
Press
Press any key (other than ALT and SYMB)
The STA Satellited moves the carousel to the first free position
For each sample, select the tests to run (use the and keys then, for each
test, press to confirm) or select a recorded profile (1 to 7)
Sample loading
Press to confirm
Sample carousel loading (open cover loading) Press and then
Open the sample cover (Go to ?)
Take the sample carousel out and put it on a flat surface
Put the samples in the carousel: the barcode label must face the reading zone
The sample must not prevent the closure of the cover
Replace the carousel and close the cover
The STA Satellited detects the newly loaded tubes in the carousel
If the plasma has been transferred into a microcontainer, press before the
reading of the barcode label and follow the procedure described below
? Test status
Check the remaining quantity of each reagent
For each sample, select the tests to run (use the and keys then, for each
test, press to confirm) or select a recorded profile (1 to 7) Press to quit the menu

Press to confirm
(Go to ?)

Sample
Loading
 STAT Samples
The STA Satellited gives priority treatment to STAT samples during the running of tests. To get a STAT result on a sample already identified or loaded
When the analyzer is operating, a STAT sample may be loaded only if the tests in
progress are complete. On the Test panel, position the cursor on the desired sample using the and
The loading of a STAT sample may be performed with a closed cover (through the hole keys
located in the cover) or with an open cover. Press to confirm
The closed cover loading procedure is described below. Press to indicate that it is a STAT sample and to confirm
For the open cover loading procedure, please refer to the “Sample Loading” chapter.
The STAT sample becomes yellow on the Test panel
Test panel
Press
The STA Satellited moves the carousel to the first free position

Sample loading
Press to indicate that the sample is a STAT sample
If the sample is a STAT sample transferred into a microcontainer, press and
then
Put the sample into the carousel through the hole located in the sample cover with
the barcode label in front of the window of the barcode reader
Press any key (other than ALT and SYMB)
Select the tests to run (use the and keys then, for each test, press to
confirm) or select a recorded profile (1 to 7)
Press to confirm
The STAT sample becomes yellow on the Test panel

STAT
Samples
 File Deletion
This procedure has to be done at the end of the day. Deleting one or several files
This option is also available after turning the STA Satellited on but in this case, no file
selection is possible. Press
Select the first file to delete using the and keys and press to confirm,
This option is only available if there are no tests in progress and if the printouts then select the last file to delete following the same procedure
previously scheduled have been processed. In the “File Deletion” window, type the prefix identification and then press to
confirm

The files deleted through this procedure will be permanently deleted.

OR Type the first digit(s) or letter(s) of the required patient file identifications, and
Test panel press to confirm
Press to go to the main menu
In the main menu, choose “Files” and then “Delete Patient Files”
OR Leave this area blank (no prefix) and press to confirm
File deletion
Use to display a colored square near the type of file to delete

Deleting all the files If a particular type of file must not be deleted, press to remove the colored
square
Press
Type YES to delete all the files and then press to confirm
All the files are deleted when the message “The Work File is empty” is
displayed
Press to go to the Test panel
When all the parameters of the selection are set, press
Type YES and press to confirm
Press to go to the Test panel

File
Deletion
 Sample Unloading

Samples should be stored from the STA Satellited as soon as they are finished Unloading a single sample
processing.
Test panel
Unloading a complete sample carousel Press
Test panel
Sample loading
Press
Press any key (other than ALT and SYMB)
Sample loading Position the cursor on the sample to unload (using the direction arrow keys)

Open the sample cover Press

Take the sample carousel out and put it on a flat surface The STA Satellited places the tube that must be unloaded in front of the barcode
reader
Unload the tubes and put the carousel back in the analyzer
Unload the tube
Close the sample cover
The STA Satellited detects the tube that has been unloaded from the carousel
Press any key (other than ALT and SYMB)
Press and then
The STA Satellited detects the samples removed from the sample carousel
Test status
Test status
Press
Press

Sample
Unloading
 Product Unloading

It is recommended to keep the STA Satellited in standby mode, at the end of the day. Unloading a single product carousel
This allows automated conservation of the reagents by the analyzer and control of their
stability. Never remove or move product carousel during single product unloading. If moved,
proceed to complete loading again.

Unloading a complete product carousel

Test panel
Test panel
Press
Press
Product loading
Product loading
Open the product cover
Press Press any key (other than ALT and SYMB)
Open the product cover Position the cursor on the product to unload (using the direction arrow keys)
Press any key (other than ALT and SYMB) Press
Take the product carousel out and put it on a flat surface The STA Satellited places the vial that must be unloaded in front of the barcode
Unload the empty reagents or the ones with stability overdue (displayed in red on reader
the screen) Unload the product
Put the carousel back in and close the cover The STA Satellited detects the vial that has been unloaded from the carousel
Press any key (other than ALT and SYMB) Close the product cover
The STA Satellited detects the vials removed from the carousel Press
Press or identify once again the remaining products Press
Test status Test status

Press Press

Product
Unloading
 Maintenance

For further information on the user maintenance, please refer to the STA Satellited
Reference Manual.

Every week
Clean the carousels
Clean the washing well and the needle
Clean the sample and product compartments
Clean the rail glass
Clean the rail, sample and product covers as well as the needle passage
Clean the monitor
Clean the rail
Clean the optical sensor
Clean the shield
Clean the covering

Maintenance

At the Heart of Haemostasis
Diagnostica Stago S.A.S.
RCS Nanterre B305 151 409
9, rue des Frères Chausson
92600 Asnières sur Seine (France)
Tél. +33 (0)1 46 88 20 20
Fax: +33 (0)1 47 91 08 91
webmaster@stago.com
www.stago.com