Professional Documents
Culture Documents
Instruction Manual. Phoresis Ref Version - 02
Instruction Manual. Phoresis Ref Version - 02
MANUAL
Version 8.63
PHORESIS 2015/02
Ref. 1110
PHORESIS SOFTWARE - 2015/02
CONTENTS
1. FOREWORD................................................................................................................................................................ 5
3. INSTALLATION........................................................................................................................................................... 8
3.1. TECHNICAL SPECIFICATIONS AND ENVIRONMENTAL CONDITIONS .......................................................... 8
3.1.1. TECHNICAL SPECIFICATIONS ............................................................................................................. 8
3.1.2. RECOMMENDED PC SYSTEM REQUIREMENTS ............................................................................... 9
3.1.3. ENVIRONMENTAL CONDITIONS FOR OPTIMAL PERFORMANCE ................................................. 10
3.2. UNPACKING AND CHECKING THE CONTENTS ............................................................................................. 11
3.3. SETTING UP THE SOFTWARE ........................................................................................................................ 12
1. FOREWORD
In order to provide maximum performance at all times, users of this software must become
acquainted with the warnings given in this instructions for use.
Warnings are provided in the following way:
CAUTION: This sequence must be followed when shutting down, otherwise a malfunction may
occur in the software or PC.
This software must be used by qualified and trained persons.
Responsibilities of SEBIA:
SEBIA may only be deemed responsible for consequences on the software’s reliability and
specifications if:
- the software is operated in accordance with the instructions herein,
- the scanner used for gels scanning is the one recommended by SEBIA (please contact SEBIA for
information about the recommended scanner).
The specifications of the PHORESIS software are as described in this document. SEBIA reserves the
right to alter these specifications without prior notice.
Instructions for use printed on paper are available from SEBIA Technical Service.
In an instruction for use, every modification from the previous version is written in red.
IMPORTANT: Every previous version must be cancelled.
The assembler, the installer or the importer cannot be held responsible for data loss due to hard disk
failures on the PC.
It is therefore highly recommended to back up daily the sample results.
The PHORESIS software program and the present instruction manual are protected by Copyright Law
and International Treaties.
The PHORESIS software has been tested and validated in the presence of the ESET® NOD 32
antivirus. Due to the large number of different marketed antivirus softwares, it is impossible for SEBIA
to test PHORESIS with all these antivirus softwares. During installation, the operator must
imperatively verify the compatibility between PHORESIS and his antivirus software.
Any failure of PHORESIS due to the incompatibility between both systems will not be in any case
attributable to SEBIA.
Contact the SEBIA Technical department for further information.
WARNING: Some antivirus softwares may stop the PHORESIS operation. According to the
antivirus software that is used, it is recommended to inactivate it during PHORESIS
installation and to configure it in order not to impede proper PHORESIS operation.
NOTES:
- The screen pictures and dialogue boxes presented in this instruction manual may vary according to
the instrument on which the PHORESIS software has been installed.
- The PHORESIS software includes particular menus specific for each instrument that are not
described in this instruction manual. See the corresponding instruction manual of the instrument for
additional information.
2. PRINCIPLE
PHORESIS is a software intended for:
- the control of SEBIA capillary electrophoresis instruments and of instruments designed for
scanning HYDRAGEL electrophoresis agarose gels and,
- the exploitation of data obtained using these instruments.
For the control of SEBIA capillary electrophoresis instruments, this software allows to perform the
techniques that are available on each instrument. The parameters and cycles corresponding to each
type of test are programmed and the analysis sequence is continuously displayed on the screen.
Special automated cycles may also be launched by the operator using PHORESIS: instrument shut-
down, capillary activation, etc…
For the scanning of HYDRAGEL electrophoresis gels, this software, installed on a PC and linked to a
high definition flat-bed scanner or to the SEBIA GELSCAN, allows the acquisition, elaboration and
conversion of pictures from this scanner or the GELSCAN.
PHORESIS allows:
- the reception on PC of performed analyses,
- the electrophoretic pattern display,
- the automated treatment of results,
- the results validation,
- the results printing,
- the quality control management,
- the data storage,
- analyses transmission to a laboratory information system,
- analyses sending and reception by e-mail.
3. INSTALLATION
MAIN PC ADDITIONAL PC
• Memory RAM 4.0 GB 800 MHz, • Memory RAM 4.0 GB 800 MHz,
Hard disk 160 GO Hard disk 160 GO
1
Please use an adaptor (ref. No. 90000001) for PCs without enough serial ports.
Please refer to the instruction manual of the computer and of the scanner.
Check that all the items listed below are present and intact:
- 1 software CD-ROM,
- 1 instruction DVD-ROM.
Windows® has loaded, click on the PHORESIS icon from the desktop .
It is also possible to run PHORESIS program by proceeding as follows:
- click on the "Start" menu,
- then, select "All programs",
- click on PHORESIS.
When double clicking on the PHORESIS icon , the following windows are displayed:
and then:
The initials "ADM" are already entered by default. The operator ID gives access that is limited
according to the privileges granted to each operator (see 4.3.8.5. OPERATOR LIST).
Enter "sebia" in the password field to gain access to the PHORESIS software.
The commands that operate the PHORESIS software and the instrument come in menu,
command, option, tab, icon and button format.
The commands can be selected by clicking on them with the mouse or from the keyboard.
PLEASE NOTE:
- The passage of the mouse cursor over an icon displays information about this icon.
- A command displayed in grey means that it is not available for use (has not been
configured, cannot be accessed or is optional).
KEY FUNCTION
Enter Validate
Go to start of text
Previous page
Next page
Line up / down
Go to next field
+ Go to previous field
To quit a dialogue box without applying changes, click on "Cancel" or the ( ) button in the
top corner of the dialogue box.
To confirm a selected item and / or a data entry, click on "OK" or "Yes".
Menu bar
Toolbar
(icons)
Command
Option
Status bar
The icons present in the toolbar make it possible to directly activate a function of a menu.
The main menu allows to select a range of functions from:
- the menu bar,
- the status window,
- the status bar.
The file menu allows the user to display or change the software settings, view the
pre-selected printer options, program the result report and shut down the software.
A click on the icon from the toolbar will also open this command.
LABORATORY TAB:
Click on the Laboratory tab to enter the name of the laboratory that will
appear in the result report header for each analysis program and in the
header on the detailed card (that is the sheet showing the IF image and
the quantitative protein results, see § 4.3.7.1. MATCHING AN IF IMAGE
TO A PROTEIN(E) CURVE).
INSTRUMENT TAB:
HOST TAB:
This tab allows the link to the host system to be activated or deactivated.
Reserved for use by the Technical Department.
LANGUAGE TAB:
This tab allows the displayed language to be changed. Reserved for use
by the Technical Department.
MONITOR TAB:
Click on this tab to change the Video Adjust setting, activate the main
menu wallpaper and set the screen resolution to 1024 x 768 pixels.
PLEASE NOTE: For a clearer image, select a lower video correction
setting. The video correction setting should be between 0.2 and 3.
Select the number of the instrument using the drop-down list and
validate by clicking on "OK".
NOTE: In the field "Instrument", the asterisk (*) indicates that all the
instruments installed in network are selected.
It is also possible to include the samples that have not yet been analyzed
in the sorting by the instrument serial number, when starting the
PHORESIS software by selecting the corresponding option.
- use the mouse wheel to scroll along the curves in the display pane of
the review window,
- show the alerts in zone B of the review window that indicate that
aberrant values have acquired (see § 4.3.3.2. EDIT CURVES),
- synchronize the IT bar code modes for all instruments that are
connected to the database.
This command allows to select the printer and to access to the printing
options.
Format editor
Label selection
bar
ICONS FUNCTION
Text alignment
Select this card to program the default normal result report, extended
result report (Standard English A5 (Ext); IF/BJ image and quantitative
results on the same page), detailed card (Standard English Card; IF/BJ
-22/142- SEBIA INSTRUCTION MANUAL - English
PHORESIS SOFTWARE - 2015/02
image and quantitative results on a separate page), compressed printout
PLEASE NOTE:
Normal report: is used to print the result report without the card.
Extended report: is used to print the result report when the curve is
linked to a card. The IF image is then shown on the result report.
Card: is used to print the IF image.
Summary report: is used to print several result reports on the same
sheet paper.
History window: allows to select the report layout used to show the
anteriority displayed on the normal report layout.
SUMMARY REPORT:
Select this tab to set the number of results to be printed on each page and
the page orientation.
PAGE:
Select this tab to activate and deactivate the gridlines and symmetry axes,
and to set the gridline units of measurement and the page size.
- click on the button to select a field to add to the result report sheet,
- the field will appear at the top of the result report after confirmation. To
move the label to another position, click and drag,
Use the exit command to close the PHORESIS software before shutting
down the PC.
- click on "Start",
- click on "Shutdown",
- click on "Shutdown".
CAUTION: This sequence must be followed when shutting down,
otherwise a malfunction may occur in the software or PC.
When the instrument is still active, the following warning message is
displayed to start a shutdown cycle:
Use this menu to create, access and / or print the list of patient information related to
the results for each analysis program.
Data can be entered at the keyboard or be uploaded from an external computer
linked to the main system (see § 4.3.6. "HOST" MENU).
- The sample number links the patient data in the worklist to the results.
- The data fields are the same as those in the "worklist by table"
command (see § 4.3.2.2. WORKLIST BY TABLE).
BUTTONS FUNCTION
WORKLIST FIELDS
Use the "Worklist fields" (displayed at the screen when clicking on the
"Options" button) window to define which fields are to be shown on the
worklist per patient.
- the print setup of fields in the worklist ("Print options …" button),
-27/142- SEBIA INSTRUCTION MANUAL - English
PHORESIS SOFTWARE - 2015/02
- the "albumin mode" where the saved concentration for the sample is
that of albumin,
- the display options for validated samples, pending samples, and with
history and pathological history,
- the display of pending samples at the top or at the bottom of the list,
- the automatic age calculation,
- a check on redundant file numbers,
Pending samples
This option allows to display pending samples at the top or at the bottom
of the working list.
Use this command to enter patient data into a table at the current date.
IT list
Worklist by table
The samples are identified using a number of line in the worklist by table
("Line") and a number of analysis ("No.") or electrophoretic pattern. These
2 numbers are independent in order to be able to sort all data from the
same patient and to keep the number of the line in the worklist.
NOTE: The user has to enter the profile number.
- the "mmol/mol" and "cal %" columns indicate the obtained HbA1c
concentrations in these 2 units,
- the "Calibration ID" column presents the date and the time of the
instrument calibration used for the analysis,
- the "Flag" column presents the number of flags (>) (or alarms)
displayed in the "Fraction values" zone of the review window for HbA1c,
- the "Fraction flags" column displays the alarms A2 (!) and F (!) that
correspond to samples with ß-thalassemia or samples with Hb F >
15 %, respectively.
With the URINE analysis program, the proteinuria of a urine sample that
has been previously entered in the "Conc." column from the work list is
BUTTONS FUNCTION
Tube bar code This mode allows to use the tube bar code to identify
mode the samples
Sample rack This mode allows to use the sample rack bar code to
bar code mode identify the samples
BUTTONS FUNCTION
§ 4.3.2.1. WORKLIST FIELDS)
Remove all the sample racks from the HYDRAPLUS or ASSIST bay.
Insert the 1st sample rack followed by the next three ones (if exist) as
explained in the instructions.
Then, click on the button marked "Send bar codes to worklist" to
download the bar codes to the worklist.
NOTES:
- Lines in bold present in the worklist by table refer to curves that have
not yet been visualized, or that the inspection time of these curves is
inferior to the value of the parameter "inspection time for curve
validation" in the EDIT CURVES TAB (see § 4.3.1.1 PROGRAM
CONFIGURATION).
- Clicking again on "IT list" button will close the window corresponding to
the IT list.
Sample date, name, These fields are in the worklist. They are
age, date of birth, automatically carried over into the IT list
sex, department, ID,
concentration
BUTTONS FUNCTION
BUTTONS FUNCTION
Use this command to print the worklist table either in part or in full, by
sequence number.
With the HbA1c analysis program, the work list containing calibration
information may be printed from the "Print list" dialogue box by selecting
the "Print the calibration information" option.
Use this command to display at the date mentioned in the status bar the
profiles of the current analysis program as a series of tiles.
Profile number
NOTES:
Click on a curve to open its review window from the mosaic.
Curves are identified by their bar code if the primary sample tube has one
bar code. A line of question marks underneath the electrophoretic patterns
means that there was no bar code present on the primary sample tube.
IT window
display button
NOTE: For the normalized profiles with the Normal CDT Control, a "N"
label is displayed on the right top of the electrophoretic pattern.
Use this command to bring up the curve processing review window for the
current analysis program.
The button, on the left top of the A zone, produces the display of the
2 following buttons:
- the "Add marker" button allows to place a marker in the
form of a numbered arrow on a definite point of the curve,
- the "Remove marker" button allows to remove a marker.
- "Full scale" mode: allows to display the curve so that the highest peak
reaches, on the Y axis, 100 %.
- "Variable scale" mode: displays the curve after its calibration using a
sample control.
The Minimum mode lets users add, delete or move a minimum amount of
the graph when the cursor is displayed as a crosshair in the A area.
To insert a minimum portion, left click at the required point of the curve.
NOTE: It is possible to identify up to 10 fractions.
To delete a minimum portion, place the cursor over the minimum to be
deleted (when the cursor is over a minimum’s vertical line the crosshair
will change to a yellow label with the word MIN) and left click.
To move a minimum portion, place the cursor over the minimum to be
moved, keep the right mouse button pressed in and drag the cursor to the
required place.
NOTE: Use the optical density (OD) values displayed above the curve to
move or insert a minimum amount.
- Fraction No. 1 at the top is the fraction furthest to the left on the graph.
- With the HbA1c procedure, the results of the HbA1c fraction are
indicated in the "Fraction values" table, in concentration (mmol/mol)
and percentage (calibrated %). Passing the mouse cursor over the
results displays an icon information that indicates maximal HbA1c
concentrations and percentages.
The program gives to each fraction the name specified in the "Fraction
identification table", depending on the number of fractions (see §
4.3.8.2.6. FRACTION NAME IDENTIFICATION TABLE).
To change the name of a fraction, click on the field and enter a new name
(no more than ten characters).
To display the fraction concentrations in zone B, enter the total protein
concentration level in the "concentration" field on the worklist (see
§ 4.3.2.2. WORKLIST BY TABLE).
The concentration unit is the one selected for the quantitative protein
result in the "worklist fields" window (see § 4.3.2.1. WORKLIST FIELDS).
To view the integral value for each fraction in zone B, click on the
button (in zone V). Clicking on the button (also in zone V) will show
the concentrations in place of the integrals.
An alert shows that the values for each fraction are greater or lower than
the standard values entered in the standards table in % or g/L (see §
4.3.8.2.3. NORMAL RANGE IN % or § 4.3.8.2.4. NORMAL RANGE IN
CONC.).
Use the fields and the buttons from this window to enter new Hb patterns,
albumin concentration level has been entered using the button (the
software calculates the total protein concentration from albumin
concentration and percentage).
NOTE: The concentration unit is defined in the "worklist by table" options
(see § WORKLIST FIELDS).
options from the work list), and the "Urine Ratio" field ( )
indicates the urine ratio that is a calculated coefficient used for the
selection of the dilution mode to apply for the immunotyping of a sample
exhibiting a monoclonal peak (see the package insert of the
CAPILLARYS / MINICAP URINE kit).
icon information by passing the cursor on the button from a ratio field
Use the select buttons to bring up the next curve ( ), the previous curve
ZONE E: COMMENTS
To add a comment from a list, click on the drop-down list and then on
the required comment.
NOTE: The comment list is specific to a technique. Therefore, it is not
possible to import a comment from a comment list of a different technique.
To add more than one comment, click on the "Additional comments"
NOTES:
- The text of the comment to import is set in the "comment lists" function
(see § 4.3.8.2.2. COMMENT LISTS) and select HYDRAGEL IF /
BENCE JONES program.
BUTTONS FUNCTION
ZONE H: PEAKS
- left click, keep pressed in and move the cursor over the part of the
curve to integrate.
- Click on the button to show this in g/L or g/dL (if the protein
concentration is known).
To alter the integration area, click on the button ("from bottom to top"
the button.
NOTE: The button is gray-dashed when it is inactive.
.
For immunotyping, the "Urine ratio" button allows to integrate from valley
to valley the part of the electrophoretic pattern that contains the abnormal
peak. Then, the "Ratio urine", defined by the proportion of the abnormal
fraction area related to the Normal Control Serum proteins total area, is
automatically calculated and is displayed in the "Urine Ratio" window
from zone C in the review window. This ratio will be used in the
CAPILLARYS or MINICAP IMMUNOTYPING URINE procedure to
determine the sample dilution mode to use ("HYPOGAMMA",
"STANDARD" or "HYPERGAMMA"). The integrated peaks are displayed
in the "Peaks" zone and are called Ratio1, Ratio2… The buttons intended
for the selection of the integration mode ("from bottom to top" integration
or "from valley to valley" integration) and for displaying the percentage or
bar code label, a purple warning signal appears when optical density
(OD) is insufficient (call SEBIA Technical Department).
See the SEBIA CAPILLARYS or MINICAP CDT kit package insert.
In all cases, the different migration zones (Z1 to Z15) do not appear
neither on the screen of the system, nor on the ticket result.
The patient data shown are the same data that were entered in the
worklist (see § 4.3.2.2. WORKLIST BY TABLE).
To bring up all a patient’s data, click on the button and keep pressed
in to display the following window:
Zone K shows the name of the analysis program being used, the initials of
the operator that were entered when the program was started and the
serial number of the automated instrument.
ZONE O: REAGENTS
Zone O shows the lot number and expiry date of the reagents entered by
the operator.
- Redraw (= Delete the not significant part of the curve between alpha 1
and albumin fractions) (set by default): the optimized curve is retraced
by bringing the albumin fraction close to the alpha-1 fraction.
CAUTION: The "Redraw" mode cannot be run if there is a serious
deficiency of alpha-1 antitrypsin, certain bisalbuminemia or high
concentrations of triglyceride.
Clicking on this icon will save any changes made to the review window
and then close it.
- Identification according to the bar code on the tube: this mode allows to
use the bar codes on the tubes to identify the samples.
- Identification according to the bar code on the sample rack: this mode
allows using the bar codes on the racks to identify the samples.
Display type
To change the layout of the profiles, click on the drop-down list and select
the required layout. The modification would also be done for all the other
analyses made in IMMUNOTYPING 6 technique.
Date
Shows the date on which the immunotyping analysis was performed.
Dilution
Shows the dilution mode that has been selected for the IT analysis.
Validation button
Original curve
The table underneath the profiles shows the program name, the date, the
work sequence number and the file number of the protein curve if this
curve has been matched to the IT curves.
To match the IT curves to the protein curve, click on the button. The
following dialogue box is then displayed:
Select the protein curve analysis program from the drop-down list in the
"Program" section. The sections of this dialogue box are described in
§ 4.3.4.1. SEARCH FOR PATIENT HISTORY.
BUTTONS FUNCTION
Use the select buttons to bring up the 6 next IT curves , the previous
ZOOM MODE
Use the zoom mode to magnify the profile an infinite number of times. To
Use the manual baseline mode to alter the baseline. Do this by clicking on
the button and then by clicking on the appropriate spot on the curve.
Click on the button, move the cursor to the required spot on the
curve and left click to confirm.
NOTE: To show the point where the left-shift began, move the cursor to
the right and vice-versa.
Click on the button and then click in zone A on each side of the
artifact that is to be removed. Define the curvature of the new line by
clicking a third time between the green vertical lines that represent the
artifact to be deleted.
The new line will pass through the two vertical lines and the cursor’s
horizontal position.
Click on the button and then click on each side of the part of the line
that is to be deleted.
SMOOTHING MODE
NOTES:
- The smoothing mode is displayed in grey and is not available with the
NEONAT Hb procedure.
O.D./T% MODE
By clicking on the button, print the result report for the displayed
curve.
NOTE: This curve becomes the first sample of the series. To visualize the
CONCENTRATION MODE
INTEGRALS MODE
By clicking on the button, display the integral values for each fraction
in the "FRACTION VALUES" section.
Clicking on the button will bring up a box to alter the scale of the
curve’s Y-axis from 1 % up to 10,000 %.
After a click on the button, the new value will apply to all the curves.
QC MODE
To mark a sample as QC, click on the icon on the edit curve screen.
This will prompt the operator to select the level of QC the sample is to be
- zoom,
REFRESH MODE
Clicking on the button refreshes the data in the review window when
new information has been entered in the worklist (without closing the
curve review window).
CAUTION: Changes are automatically stored when:
- the next or previous curve is displayed,
- the review window is closed,
window ( ).
(2/2)" window ( ).
- The icon information "Patient history search not possible, age or date
birth field empty" when the patient’s age or birth date is not indicated in
-70/142- SEBIA INSTRUCTION MANUAL - English
PHORESIS SOFTWARE - 2015/02
the work list. After a click on this button, the following dialogue box will
appear:
becomes .
A click on the icon displays the window that presents the previous
curves of the patient.
The curve corresponding to the selected date and the fraction values are
shown in blue; previous results are in grey. The line that is highlighted in
the PREVIOUS SAMPLES table and the comments refer to the previous
results.
If many analysis results are available, click on the different lines to view
them.
BUTTONS FUNCTION
Print highlighted Prints a copy of the curve for the previous result
sample that has been selected
BUTTONS FUNCTION
samples
NOTE: In the worklist by table, the line of the sample with history is
colored in pink.
Use this command to display and print the working day’s results of the
current analysis program under a format table.
With the HbA1c analysis program, the results obtained are presented in
the result table including the following specific columns:
- "HbA1c flags" : this column presents the number of flags (>) (or
alarms) displayed in the "Fraction values" zone of the review window
for HbA1c,
- "Fraction flags" : this column displays the alarms A2 (!) and F (!) that
correspond to samples with ß-thalassemia or samples with Hb F >
15 %, respectively.
With the URINE analysis program, the results obtained using manual
peaks quantification are presented in the result table (configured by
default) including the following specific columns:
With the NEONAT Hb analysis program, the obtained results are reported
in the result table with specific additional columns:
- "Hb A", "Hb F" and "Hb A2": normal fractions with a specific color that
is the same as that of the quantified peaks in the review window: pink
for Hb A, blue for Hb F and yellow for Hb A2,
- "Hb S zone", "Hb C zone", "Hb E zone"…: abnormal fractions
coloured in grey,
The result table indicates only the analyses of the current day and the
suspended samples. The analyses without any electrophoretic pattern,
(such as analyses with a too low maximal optical density and samples
imported that have not yet been analyzed) are not shown in the table of
results.
BUTTONS FUNCTION
Close Closes the window
Refresh Updates the data if changes were made in the
review window
Print Insert the range of samples to be printed
Sort To sort the available fields (according ascending
or descending order)
Set up To configure the result table from available fields
(according ascending or descending order)
Use this command to call up the records for the relevant analysis program
(it can also be activated by double clicking on the analysis program in the
status bar).
To use a different analysis program, select a new program from the list
and click on "OK" to confirm.
NOTE: The current analysis program is indicated in the status bar.
Use this command to print the result reports for the analysis program that
was running on the date shown in the status bar.
Use this command to print the result reports according to selected criteria
listed in the following window:
Use this menu to carry out search operations in the stored curves.
Use this command to find a saved entry by the instrument, the name of
the analysis program, the sample type, the comment, the working date,
the patient data, the name of the operator or the lot number of the
reagents that have been used.
INSTRUMENT
Use this function to select the instrument and its serial number from the
drop-down menu ( ).
Use this function to select the analysis program from the drop-down menu
SAMPLE TYPE
COMMENT SEARCH
RANGE OF TIME
PATIENT DATA
Use this function to search by patient data (name, date of birth, sex, age,
number of sample, sample date, ID – sample identification, concentration
or department), to search a control sample (lot number, control type) or to
search by the name of the operator or the lot number of the reagents that
have been used.
With the NEONAT Hb analysis program, the search can be performed
using the date of the filter paper punch, the bar code of the dilution
segment and the sample collection data.
Click in the appropriate field and type in the search string.
CAUTION: The data entered in the date of birth and identification
fields must be exact. A partial string can be entered in the name and
department fields to carry out a search.
Search results
In that case, click on "OK" and then on to carry out a new search.
- If the result is successful, a list of those records that meet the search
criteria will be displayed.
The records that have been found are displayed according to the date of
analysis.
The highlighted sample curve is displayed in the top right-hand corner.
The displayed table indicates information regarding the sample (name of
the patient, date of birth, sex and age) and the analysis (working date,
program identification, ID – sample identification, department, operator, lot
number of the reagents that have been used, information on profiles and
fraction flags).
The "Card" column shows whether a detailed patient card has been
entered (see § 4.3.3.2. ZONE F: ATTACHED CARD). In such a case, the
symbol is then displayed for the concerned sample.
The "Pathological" column shows whether the sample is pathological (see
§ 4.3.3.2. ZONE G: PATHOLOGY). In such a case, the symbol is
then displayed for the concerned sample.
BUTTONS FUNCTION
BUTTONS FUNCTION
View all Displays all the curves, starting from the 1st sample that
has been found
The icon will print a summary report of all the samples in the table or
print the worklist.
Use this command to extract from the list of the day’s series for the
selected date the curves that have a higher or lower number of fractions
than the number configured in the "Analysis programs" window (see §
4.3.8.2.1. ANALYSIS PROGRAMS).
The "Search results" window indicates the number of curves that have
been found. To view and, if necessary, alter the curves, confirm the
search (see § 4.3.3.2. EDIT CURVES).
Once the worklist has been brought up, this command can be used to
check if one or more patients in the day’s series are listed as having
known pathological samples.
NOTE: The search is carried out on the names in the worklist of the day.
The checking is initially made based on samples flagged as pathological,
the right name, the name and age or date of birth to avoid same-name
matches.
Use the search mode window to specify the search criteria (name, name
and age, name and date of birth, etc.).
Use the search mode window to specify the search criteria: name, name
and age, name and date of birth.
Click on "Start search" to launch the search procedure. When the search
is complete, the program will show the number of samples that have been
found and propose displaying the list of patients with known pathological
samples on the selected date.
When a known pathological sample is used or dearchived, an underlined,
orange label indicating "Known pathological patient" will automatically be
indicated in the graph.
The curve corresponding to the selected date and the fraction values are
shown in blue; previous results are in grey. The line that is highlighted in
the PREVIOUS SAMPLES table and the comments refer to the previous
results.
If many analysis results are available, click on the different lines to view
them.
A click on the "See the patient history list" button from the review
window allows to display directly the dialogue box "View previous samples
for known pathological patient".
BUTTONS FUNCTION
NOTE: In the worklist by table, the line of the sample with history is
colored in pink.
Use this command to reset the database by erasing the flag indicating
patients with known pathological samples.
Use this command to search for the samples that have not been validated
(see § ZONE N: VALIDATED SAMPLE) for the current analysis program.
The records that have been found are displayed according to the date of
analysis.
The highlighted sample curve is displayed in the top right-hand corner.
The displayed table indicates information regarding the sample (name of
the patient, date of birth, sex and age) and the analysis (working date,
program identification, ID – sample identification, department, operator, lot
number of the reagents that have been used, information on profiles and
fraction flags).
The "Card" column shows whether a detailed patient card has been
entered (see § 4.3.3.2. ZONE F: ATTACHED CARD). In such a case, the
symbol is then displayed for the concerned sample.
The "Pathological" column shows whether the sample is pathological (see
§ 4.3.3.2. ZONE G: PATHOLOGY). In such a case, the symbol is
then displayed for the concerned sample.
BUTTONS FUNCTION
The icon will print a summary report of all the samples in the table or
print the worklist.
Use this command to reset the database by updating the patient history
information.
This menu allows access to all the commands used to manage the stored data.
If the working date is the same as the current date, "Current Date Mode"
will be displayed in the status bar.
To alter the working date, click on the "Change working date" command or
double click on the working date in the status bar.
Type the required working date in the dialogue box (under mmddyy or
mm/dd/yy format). When the working date is changed, "Recall Mode" will
be activated.
To quit Recall Mode, click on the "Change working date" command. The
dialogue box will then indicate the current date. Click on "OK" to confirm.
Clicking on the icon allows coming back to the current date mode.
Use this command to show samples filed according to the date, the
analysis program and the instrument.
For each table, this dialogue box shows the save dates, the number of
analyzed samples and the number of curves that have been stored for the
indicated instrument and analysis program.
To view the curves that have been filed for another program, click on the
Particular case:
With the CAPILLARYS or MINICAP HbA1c procedures, the dialogue box
displays also the curves with "Atypical profile" and that with "Increased
HbA1c value".
BUTTONS FUNCTION
BUTTONS FUNCTION
This command can also be run by clicking on the "Move" button in the
"WORKLIST BY TABLE" dialogue box.
Use this command to transfer curves and related patient data to the
worklist of the current analysis program by entering the reference
numbers of the samples that are to be moved and their new transfer
numbers.
NOTE: The transfer will not take place if the destination is already
occupied and if the IT curves have been matched to the protein curves.
BUTTONS FUNCTION
Backup samples:
After a click on the "Backup samples" tab, the following
dialogue box will open:
NOTES:
- Moving data (by clicking on the "Move" button) will result in
the information being removed from the PHORESIS
database.
- If duplicate data is found on the designated backup folder,
a prompt will appear indicating, "The following sample
exists already… (program name, sample date, and
number)…Do you want to replace it ?" Select, Yes, All, No,
None, or Cancel.
- The "Delete" button will permanently remove the selected
data from the PHORESIS database, unless it has been
previously backed up (onto a CD or DVD-ROM for
example).
Restore samples:
Select the "Restore Samples" tab to restore samples from a
backup folder to the PHORESIS database using the
"Database Folder path".
The following dialogue box will open:
The system will search for all data that are in the designated
folder and will display the program name(s).
NOTES:
- The "Move and delete" button will permanently delete the
selected data from the backup folder.
- To delete the selected records, click on the "Delete" button.
CAUTION: The delete operation is irreversible.
Use this command to reduce the size of image files to send them.
NOTE: It is advised to create a backup copy of the database before using
this command.
Select the "HOST" menu to create a two-way network link with a host computer for
downloading the worklist and transferring the related sample results after analysis.
NOTE: The worklist can be downloaded before or after analysis.
To activate the host connection, click on the icon. The following window is
displayed:
The host system has the capability to import a worklist from a LIS system and to
export the corresponding data to the same LIS.
- To receive data from the host, click on "Import Worklist". A window will come up
asking which specimens are to be imported. Select correct numbers and click on
"OK".
- To transmit data to the host, click on "Export Result". A window will come up
asking what specimens are to be exported. Select the correct number and click
on "OK".
It is possible to export data in the "Recall Mode". When the Host is activated in
"Recall Mode", the operator will be given notice that they will be transmitting data
that is not from the current date.
NOTE: Within the host there are two host languages available: english or italian.
Use this menu to scan HYDRAGEL gels from a flatbed scanner (please contact
SEBIA for information about the recommended device).
Use this command to open the "Gels and samples scanning" window.
- check the glass surface of the scanner bed is clean ; if not, clean the
glass surface according to the following indications:
- If the glass surface gets dirty, clean it with a soft dry cloth. If the
glass surface is stained with any hard-to-remove material, use a soft
cloth and damp it with cold water, wring it out before use. Clean the
glass surface from one side to the other one, and wipe off all
remaining liquid with a soft dry cloth.
CAUTION:
- Do not press the glass surface of the scanner bed with any
force.
- Then, place the gel alignment frame back on the glass surface,
make sure that it is in the correct position and secure it to the edge
of the glass surface.
- Gels should be placed Face Down (within each part of the gel
alignment frame) with the bottom of the gel towards the bottom of the
scanner.
- Place the small weights on the top and bottom edge of each gel.
After the gels are placed on the scanner, select the scanning icon.
SCANNER SETTINGS
Program name
Gel frame
The scan area is split into six rectangular frames, enabling up to six gels
to be scanned within the same scanning sequence.
The gel alignment frame is necessary to line up the gels in correct position
on the scanner bed.
Each frame is identified by the gel number and the analysis program that
is going to be used.
Each frame can hold a gel obtained by a different method.
- numbers shown with a white background refer to samples that will not
be scanned.
- To change the number of samples on a gel, select the gel type and
click on the number in the "Gel sample number" section. The "Change
sample number" window will come up.
- The beginning and the end of the scanning sequence can be viewed
on the gel image by checking the "Trace Scan Line" box. This option is
not available for the IF/BENCE JONES, CSF and URINE programs.
NOTE: The red lines on the gel track allow the user to verify that the gel
was correctly lined up.
IMAGE ACQUISITION
Click on "View scanning" in the "Scanner reading" window. This will bring
up the following dialogue box:
Navigation pane
Scan position line
- the scan position line (verify that the scan position lines on the gel are
in the appropriate places).
Magnified image
To insert corrections, double click on one of the tracks on the magnified
image to bring up its curve review window.
BUTTONS FUNCTION
When the scanning sequence is over, the "IF/BJ, CSF, URINE sample
selection" window will open. The immunofixation pattern is to be matched
to a PROTEIN(E) curve.
Enter the PROTEIN(E) sample number and choose the analysis program
of the protein electrophoretic pattern to which the immunofixation pattern
will be matched. To finish, click on "Verify".
A second window will open asking to confirm the information entered.
Click on "Yes" to confirm.
If you do not wish to confirm, click on "No" and repeat the scan procedure
after checking that the patient data that has been entered is correct.
Repeat the above steps until the immunofixation gel acquisition procedure
is complete (for HYDRAGEL 2 IF, 4 IF or 9 IF gels).
IMMUNOFIXATION
gel worklist
Corresponding
PROTEIN(E)
sample
This window displays for each patient (from the scanned gel worklist) the
sample analysis in PROTEIN(E) program matching the search criteria
(same name and/or same ID).
Select the analysis to perform by crossing the corresponding box.
Clicking on "OK" creates the requested links.
BUTTONS FUNCTION
Use this command to show the two last scanned images on the current
date.
NOTE: This command is not available for the HYDRAGEL IF / BENCE
JONES, HYDRAGEL IF / BENCE JONES HR, HYDRAGEL CSF,
HYDRAGEL CSF ISOFOCUSING and HYDRAGEL URINE PROFIL(E)
analysis programs.
This function allows the patient sample traceability, from the identification
of the collection tube placed on the ASSIST / HYDRAPLUS sample rack
to the final result obtained with the scanner.
This identification system is applicable to all techniques that are available
with ASSIST / HYDRAPLUS instrument and for all HYDRAGEL
procedures performed with the HYDRASYS 2 instrument.
To fill in the identification fields, mono and bidimensional barcodes must
be scanned using the SEBIA HYDRAGEL barcode reader, PN 1080.
See the instructions for use of the SEBIA Gel barcode labels, PN 9206
(500 units) and of the SEBIA Applicator barcode labels, PN 9207
(500 units).
Use this command to calculate statistics, enter control values and display
LEVEY JENNINGS charts.
4.3.8.1.1. STATISTICS
INSTRUMENT
WORKING PROGRAM
RANGE OF TIME
Check one of the three option boxes. Enter the dates where
required.
This option lets the operator enter the name, lot number,
number of fractions, total protein concentration and unit of
measurement, and the control values (median values and
standard deviations) for each type of control, in the current
procedure.
Refer to the values provided in instructions for use of each
control.
NOTE: With the HbA1c procedure, the table for control values
presents 2 units for the HbA1c fraction of this control
(mmol/mol and cal %).
See the instructions for use of the SEBIA Hb A1c CAPILLARY
Controls for the determination of customized values for each
instrument.
Enter the values of this control sample (in mmol/mol AND
cal %) as previously described.
This option is only available for control sample curves that are
"QC" listed (see § 4.3.3.2. QC MODE) and when more than
3 QC samples are present in the database.
NOTE: In order to have a representative chart, use this
function once at least 30 QC samples are present in the
database (maximum: 200 QC samples).
BUTTONS FUNCTION
Opens a dialogue box from which
to select a saved file
NAME FUNCTION
Code Code required to match
measurements to the analysis
program
Name Name of the analysis program
Report headline Default text printed on the worklist
Standard fractions Normal number of fractions for the
type of analysis
Samples per gel Maximum number of tests performed
for the analysis type or number of
curves displayed in tile format on each
screen (according to the technique
used: PHORESIS SCANNER or
PHORESIS CAPILLARYS / MINICAP)
NAME FUNCTION
Visible Displays or not the name of one
analysis program in the lists of the
available programs
To change these settings and / or create a new analysis
program, click on the appropriate field.
To delete a scanner program, click on the line containing the
analysis program and then on "Delete".
NOTES:
- Some fractions are not considered for the A/X ratio
calculation, such as Hb A2 peak, Hb G-Philadelphia major
fraction, any fraction that migrates in N(C), N2, N(E), N(S)
and N(D/G/K) zones that do not meet the criteria of min %,
max % and migration time, or any fraction that migrates in
N6 to N(Bart) zones.
- When 2 peaks X can be used for the A/X ratio calculation,
the ratio is calculated using the peak that presents the
highest optical density.
- The A/F and / or A/X ratio cannot be calculated in the
following cases: absence of Hb A, of Hb F, of any Hb X, for
the control blood samples, absence of zones on the
electrophoretic pattern, samples that have not yet been
analyzed.
( ).
Enter or change the name of a fraction by clicking on the
appropriate cell.
CAUTION: The name of the fractions may be imposed by
the connection to the laboratory information system.
NOTE: The Frac.1 (fraction 1) field is the first fraction that can
be seen on the graph line furthest to the left.
Selecting this option displays the names of free fields that can
be used in the worklist.
GENERAL PARAMETERS
menu ( ).
This dialogue box shows the list of numerical codes and their
matching laboratory names, the modem numbers and e-mail
addresses used for results transferring.
This command allows to display the list of users and shows their level of
authorization (level of authorization range between 1 and 4).
LEVEL ACCESSIBILITY
Scan curves.
The "Window" menu shows all the windows that are currently open. Select a window
from the list to make it the active window.
The "Help" menu allows the user to visualize the instruction manual of the
automated instrument, of the SCANNER / GELSCAN and the informations about the
PHORESIS software.
This command allows results from the date shown in the status bar to be transferred
via e-mail to another PC using a PHORESIS software version allowing the reception
of results via e-mail.
Clicking on the icon opens the following window, after having entered the
parameters of the e-mail server:
- for each result to transmit, enter in the column "Free field 3" the
laboratory code (set in UTILITIES / CUSTOMER CONFIGURATION /
LAB. / PATHOLOGIST LIST) to which the results may be sent,
- close the "Worklist by table" window in order to take into account the
modifications.
menu ( ).
NOTE: The laboratories in the list are the same as those entered via the
dialogue box (see § 4.3.8.2.10. LAB./PATHOLOGIST LIST).
To see and edit the list of laboratories, click on the "Set …" button.
When the destination laboratory has been selected, the connection button
will become active and the results can be sent.
The file received via e-mail (containing the results) has first to be saved in
the "MAIL" folder of PHORESIS (default path is C:\Program
Files\Phoresis\Mails).
Click on the "Result import" option button to start the result reception.
Then, a dialogue window indicates the sample storage mode for the
results received via e-mail:
Clicking on the icon enables sample curves and related results matched on
the date shown in the status bar to be received over a network.
NOTE: Samples must be bar coded and must not be blocked.
Contact the Technical Department to configure the network access path.
The status bar is located at the bottom of the main menu. It indicates the working date (see §
4.3.5.1. CHANGE WORKING DATE), the current analysis program (see § 4.3.3.4. CHANGE
WORKING PROGRAM), the date mode and the IP address of the PC where the PHORESIS
database has been saved (SERVER).
Operators should always check that the information in status bar is correct to ensure that the
analysis program operates as required.
5. Click on the icon in the control curve review windows, then select the control type in
the "Save sample as QC" window (see § 4.3.3.2. QC MODE and 5.3. QUALITY
CONTROL).
6. To display the graph as a LEVEY JENNINGS chart, select UTILITIES / QUALITY
CONTROL / LEVEY JENNINGS CHART.
7. Select the control type from the drop-down menu ( ) and click on "Start" to confirm. To
see the results statistics, click on "Statistics" (see § 4.3.8.1.3. LEVEY JENNINGS
CHART). If the resulting values do not fall within the minimum and maximum limits, it is
advised to perform the analysis again with a new control. Contact the Technical
Department if the values from this second analysis are still outside the expected values.
At the end of the analysis, the relevant percentages and / or the concentrations of the different
fractions are automatically calculated.
1. To view the curves as tiled images (mosaic), select the Curves in tile format command
from the EDIT CURVES menu, or click on the icon (see § 4.3.3.1. CURVES
PREVIEW (MOSAIC)).
2. To view a curve for editing, select EDIT CURVES / EDIT CURVES or click on the
icon (see § 4.3.3.2. EDIT CURVES).
3. To program the result report, select FILE / CUSTOMIZE REPORT (see § 4.3.1.3.
CUSTOMIZE REPORT).
4. To print a copy of the result report, click on the icon (see § 4.3.3.5. PRINT
REPORTS).
The quality control (QC) process is intended to check if the results obtained are in accordance
with the specified requirements. Analyzing a control sample and comparing the results with the
expected values (provided in each control package insert) allow to measure the instrument’s
accuracy.
It is recommended to analyze at least, if they exist for the current technique, a normal and a
pathological control per analysis series.
IMPORTANT: It is necessary to use the specific bar code label intended to identify and
analyze the control corresponding to the bar code. The bar code allows to automatically
identify a sample as control sample.
To perform a quality control, proceed as follows:
1. Reconstitute the control sample with the volume indicated in the package insert of the
control.
IMPORTANT: Please carefully read the package inserts of the control bloods intended for
the analyses of hemoglobins, according to the instrument being used.
2. Set as QC the control that is going to be analyzed.
3. Introduce the provided values, as indicated in the control package insert, and the number
of fractions in the dialogue window "setup control values" (see § 4.3.8.1.2. SETUP
CONTROL VALUES).
NUMBER OF
CONTROL TECHNIQUE
FRACTIONS
CAPILLARYS Hb A1c
Hb A1c CAPILLARY CONTROL 1 1
MINICAP Hb A1c
CAPILLARYS Hb A1c
Hb A1c CAPILLARY CONTROL 2 1
MINICAP Hb A1c
CAPILLARYS CORD BLOOD
Hb AF CONTROL 2 or 3
CAPILLARYS NEONAT Hb
HYDRAGEL HEMOGLOBIN(E)
NORMAL Hb A2 CONTROL CAPILLARYS HEMOGLOBIN(E) 2
MINICAP HEMOGLOBIN(E)
HYDRAGEL HEMOGLOBIN(E)
PATHOLOGICAL Hb A2 CONTROL CAPILLARYS HEMOGLOBIN(E) 2
MINICAP HEMOGLOBIN(E)
HYDRAGEL PROTEIN(E)
NORMAL CONTROL SERUM CAPILLARYS PROTEIN(E) 6 4, 5 or 6
MINICAP PROTEIN(E) 6
HYPERGAMMA CONTROL SERUM HYDRAGEL PROTEIN(E) 4, 5 or 6
NUMBER OF
CONTROL TECHNIQUE
FRACTIONS
CAPILLARYS PROTEIN(E) 6
MINICAP PROTEIN(E) 6
HYDRAGEL ISO-LDH 5
ENZYCONTROL
HYDRAGEL ISO-CK 3
HYDRAGEL HEMOGLOBIN(E)
CAPILLARYS HEMOGLOBIN(E)
Hb AFSC CONTROL MINICAP HEMOGLOBIN(E) 4 or 5
CAPILLARYS CORD BLOOD
CAPILLARYS NEONAT Hb
CAPILLARYS CDT
NORMAL CDT CONTROL 4
MINICAP CDT
CAPILLARYS CDT
PATHOLOGICAL CDT CONTROL 4
MINICAP CDT
CAPILLARYS CDT
HIGH CDT CONTROL 4
MINICAP CDT
4. Analyze the control sample (migration and scanning). Identify as "QC" the curves of the
control sample (see § 4.3.3.2. QC MODE).
5. Once a representative number of control analyses is contained in the database, display
the LEVEY JENNINGS chart (see § 4.3.8.1.3. LEVEY JENNINGS CHART) or run
statistics (see § 4.3.8.1.1. STATISTICS).
The resulting values must fall within the range provided with each batch of control sample.
Check that the percentage of each fraction matches the specifications.
If not, it is recommended to analyze again a new reconstituted control sample. If the second
values series still don’t match to the specifications, contact the technical department.
6. MAINTENANCE
Please refer to test pattern instructions for use.
To keep the scanner operating at its best, clean it periodically using the procedure provided by the
manufacturer.
7. PERFORMANCE LEVELS
See the SEBIA kits instructions for use.
9. BIBLIOGRAPHY
See the SEBIA kits instructions for use.
● With regard to harmonized standards for EC marking (98/79/EC) of in vitro diagnostic medical
devices (IVDMD) the following applies:
- EN ISO 18113 – 1 : In vitro diagnostic medical devices - Information supplied by the
manufacturer (labelling) - Part 1: Terms, definitions and general requirements,
- EN ISO 18113 – 3 : In vitro diagnostic medical devices - Information supplied by the
manufacturer (labelling) - Part 3: In vitro diagnostic instruments for professional use,
- EN 980 : "Graphical symbols for use in the labelling of medical devices",
- EN ISO 14971 : "Medical devices - Application of risk management to medical devices".
11. INDEX
A F
C I
D M