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INSTRUCTION 

MANUAL

Version 8.63
PHORESIS  2015/02
Ref. 1110 
 
PHORESIS SOFTWARE - 2015/02

CONTENTS

1.  FOREWORD................................................................................................................................................................ 5 

2.  PRINCIPLE .................................................................................................................................................................. 7 

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 

4.  LAYOUT OF THE SOFTWARE ................................................................................................................................ 13 


4.1.  DESCRIPTION OF THE COMMANDS .............................................................................................................. 14 
4.2.  DESCRIPTION OF THE MAIN MENU ............................................................................................................... 16 
4.3.  THE MENU BAR ................................................................................................................................................ 17 
4.3.1.  "FILE" MENU ......................................................................................................................................... 17 
4.3.1.1.  PROGRAM CONFIGURATION ..............................................................................................17 
4.3.1.2.  PRINTER SETUP ...................................................................................................................20 
4.3.1.3.  CUSTOMIZE REPORT ...........................................................................................................20 
4.3.1.4.  EXIT ........................................................................................................................................24 
4.3.2.  "WORKLIST" MENU ............................................................................................................................. 25 
4.3.2.1.  WORKLIST BY SINGLE SHEET ............................................................................................25 
4.3.2.2.  WORKLIST BY TABLE ...........................................................................................................29 
4.3.2.3.  PRINT WORKLIST .................................................................................................................35 
4.3.3.  "EDIT CURVE" MENU .......................................................................................................................... 36 
4.3.3.1.  CURVES PREVIEW (MOSAIC)..............................................................................................36 
4.3.3.2.  EDIT CURVES ........................................................................................................................39 
4.3.3.3.  RESULT LIST .........................................................................................................................72 
4.3.3.4.  CHANGE WORKING PROGRAM ..........................................................................................75 
4.3.3.5.  PRINT REPORTS ...................................................................................................................75 
4.3.3.6.  CHANGE PRINTED REPORT ORDER..................................................................................76 
4.3.3.7.  SUMMARY REPORT..............................................................................................................76 
4.3.4.  "SEARCH" MENU ................................................................................................................................. 77 
4.3.4.1.  SEARCH FOR PATIENT HISTORY .......................................................................................77 
4.3.4.2.  SEARCH FOR ABNORMAL CURVES ...................................................................................80 
4.3.4.3.  SEARCH FOR KNOWN PATHOLOGICAL PATIENTS..........................................................80 
4.3.4.4.  DELETE THE LABELS "KNOWN PATHOLOGICAL PATIENT" ............................................83 
4.3.4.5.  SEARCH FOR PENDING SAMPLES .....................................................................................83 
4.3.4.6.  SEARCH FOR NON VALIDATED SAMPLES ........................................................................83 
4.3.4.7.  UPDATE PATIENT HISTORY INFORMATION ......................................................................84 
4.3.5.  "DATABASE" MENU ............................................................................................................................. 85 

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4.3.5.1.  CHANGE WORKING DATE ...................................................................................................85 
4.3.5.2.  VIEW DATABASE HISTORY .................................................................................................85 
4.3.5.3.  DELETE SAMPLES ................................................................................................................88 
4.3.5.4.  MOVE SAMPLES ...................................................................................................................88 
4.3.5.5.  BACKUP .................................................................................................................................89 
4.3.5.5.1.  BACKUP CONFIGURATION ............................................................................... 89 
4.3.5.5.2.  ADVANCED BACKUP ......................................................................................... 90 
4.3.5.6.  UPDATE DATABASE .............................................................................................................94 
4.3.5.7.  IF/BJ, CSF, URINE IMAGE COMPRESSION ........................................................................94 
4.3.6.  "HOST" MENU ...................................................................................................................................... 95 
4.3.7.  "SCANNER" MENU............................................................................................................................... 96 
4.3.7.1.  START SCANNING ................................................................................................................96 
4.3.7.2.  VIEW THE LATEST SCANNED SAMPLES .........................................................................106 
4.3.7.3.  READING MODE ..................................................................................................................106 
4.3.7.4.  POSITIVE IDENTIFICATION ASSIST/HYDRAPLUS...........................................................106 
4.3.8.  "UTILITIES" MENU ............................................................................................................................. 107 
4.3.8.1.  QUALITY CONTROL ............................................................................................................107 
4.3.8.1.1.  STATISTICS ...................................................................................................... 107 
4.3.8.1.2.  SETUP CONTROL VALUES ............................................................................. 109 
4.3.8.1.3.  LEVEY JENNINGS CHART ............................................................................... 111 
4.3.8.2.  CUSTOMER CONFIGURATION ..........................................................................................113 
4.3.8.2.1.  ANALYSIS PROGRAMS ................................................................................... 113 
4.3.8.2.2.  COMMENT LISTS ............................................................................................. 114 
4.3.8.2.3.  NORMAL RANGE IN % ..................................................................................... 114 
4.3.8.2.4.  NORMAL RANGE IN CONC. ............................................................................ 115 
4.3.8.2.5.  RATIO SETTINGS OPTION .............................................................................. 115 
4.3.8.2.6.  FRACTION NAME IDENTIFICATION TABLE ................................................... 117 
4.3.8.2.7.  CUSTOMIZE FREE FIELDS ............................................................................. 118 
4.3.8.2.8.  DISPLAY PARAMETERS .................................................................................. 118 
4.3.8.2.9.  DEPARTMENT LIST.......................................................................................... 119 
4.3.8.2.10. LAB./PATHOLOGIST LIST ................................................................................ 120 
4.3.8.3.  CALIBRATION FACTOR ......................................................................................................120 
4.3.8.4.  AUTO POWER-OFF .............................................................................................................121 
4.3.8.5.  OPERATOR LIST .................................................................................................................122 
4.3.9.  "WINDOW" MENU .............................................................................................................................. 124 
4.3.10.  "HELP" MENU ..................................................................................................................................... 125 
4.3.11.  RESULTS TRANSMISSION / RECEPTION VIA E-MAIL ................................................................... 126 
4.3.11.1.  RESULT SEND .....................................................................................................................126 
4.3.11.2.  RESULT IMPORT .................................................................................................................128 
4.3.12.  NETWORK CONNECTION ................................................................................................................. 130 
4.4.  STATUS BAR ................................................................................................................................................... 131 

5.  USING THE SOFTWARE........................................................................................................................................ 132 


5.1.  PREPARATION OF THE SCANNING.............................................................................................................. 132 
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5.2.  RESULTS OF ANALYSIS ................................................................................................................................ 133 
5.3.  QUALITY CONTROL ....................................................................................................................................... 134 

6.  MAINTENANCE ...................................................................................................................................................... 136 

7.  PERFORMANCE LEVELS...................................................................................................................................... 137 

8.  INTERFERENCES AND LIMITS OF USE .............................................................................................................. 138 

9.  BIBLIOGRAPHY ..................................................................................................................................................... 139 

10. REGULATORY INFORMATION ............................................................................................................................. 140 

11. INDEX ...................................................................................................................................................................... 141 

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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.

WINDOWS® is trademark of Microsoft Corporation.

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.

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IMPORTANT: This instruction manual has been revised for the 8.63 version of the PHORESIS
software.

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.

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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.

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3. INSTALLATION

3.1. TECHNICAL SPECIFICATIONS AND ENVIRONMENTAL CONDITIONS

3.1.1. TECHNICAL SPECIFICATIONS

Patient identification : For easy sample processing, this can either be


entered by the operator or downloaded from a host
computer system.
Displaying : The image of the electrophoretic migration is scanned
by light transmission and automatically converted into
percentages. Both gel pattern and curve are then
displayed for easier result editing and interpretation.
Data processing : • 2,400 patients per analysis program,
• control and correction,
• statistical calculations generated by analysis
program,
• detection of abnormal values,
• curves traced in graph format, data printouts,
• unidentified curves highlighted,
• immunofixation images and quantitative specific
protein results imported and printed,
• deletion of minima and fractions,
• fraction identification,
• modification of the baseline,
• curve overlay,
• a sophisticated quality control program,
• recall and review of previous results, including curve
display, is possible for each of the demographic
entries,
• SQL client / server database: unlimited storage
capacity of patients database, networking
capabilities for multi-clients management,
• curve search and edit.

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3.1.2. RECOMMENDED PC SYSTEM REQUIREMENTS

MAIN PC ADDITIONAL PC

• 3 GHz double core E5700 • 3 GHz double core E5700


processor / Multilanguage processor / Multilanguage
Windows® XP or Windows® XP Windows® XP or Windows® XP
Pro or Windows® VISTA or Pro or Windows® VISTA or
Windows® 7 (32 & 64 bits) Windows® 7 (32 & 64 bits)

• Screen: SVGA definition 1024 x • Screen: SVGA definition 1024 x


768 768

• Memory RAM 4.0 GB 800 MHz, • Memory RAM 4.0 GB 800 MHz,
Hard disk 160 GO Hard disk 160 GO

• Graphic card 65536 colors • Graphic card 65536 colors

• 5 serial ports (minimum) 1: • 1 serial port available (if connected


- 2 for V24 RS232 (if needed), to external modem)
- 2 for USB ports,
- 1 for external modem (if needed)

• CD/DVD+/-RW driver - burner • CD/DVD+/-RW driver - burner

• Keyboard, mouse • Keyboard, mouse

• Network card • Network card

1
Please use an adaptor (ref. No. 90000001) for PCs without enough serial ports.

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3.1.3. ENVIRONMENTAL CONDITIONS FOR OPTIMAL PERFORMANCE

Please refer to the instruction manual of the computer and of the scanner.

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3.2. UNPACKING AND CHECKING THE CONTENTS

Check that all the items listed below are present and intact:
- 1 software CD-ROM,
- 1 instruction DVD-ROM.

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3.3. SETTING UP THE SOFTWARE

Please install the PHORESIS software on a PC or compatible connected to a high definition


flat bed scanner (please contact the technical department for information about the
recommended scanner).
To connect the computer with the scanner, please refer to their instructions manuals.
To run the PHORESIS program, first switch on the scanner then the computer. Once

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.

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4. LAYOUT OF THE SOFTWARE

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.

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4.1. DESCRIPTION OF THE COMMANDS

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).

Description of the keys:

KEY FUNCTION

Enter Validate

Esc Escape / Cancel

Insert Insert a character

Delete Delete a character

Go to start of text

End Go to end of text

Previous page

Next page

Line up / down

Move cursor one space

Go to next field

+ Go to previous field

Num Lock Lock / Unlock of the numerical keypad

Caps lock / unlock

Alt+Ctrl+Delete Restart the system

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Data entry by the operator:
A cursor indicates that the operator may enter data.
To correct an error or simply change a data entry, the operator can:
- select the character by dragging the mouse over it and typing another character to replace
it,
- press the "Delete" key to delete the character immediately just after the cursor,
- press the " " key to delete the character immediately just before the cursor,
- add characters to those that have already been entered by putting the cursor in the required
position.
New characters that are entered will be placed just to before the cursor.
The " " position keys and the "Delete" and " " backspace keys can still be
used.

Description of the mouse keys:


- 1 click on the left mouse button : - activates the cursor,
- executes a command.
- 1 click on the right mouse button : - displays a menu.

Confirm / Cancel a command:

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".

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4.2. DESCRIPTION OF THE MAIN MENU

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.

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4.3. THE MENU BAR

4.3.1. "FILE" MENU

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.

4.3.1.1. PROGRAM CONFIGURATION

This command opens the software settings window.

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).

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PLEASE NOTE: No more than 100 characters can be entered per line of
text.

INSTRUMENT TAB:

Reserved for use by the Technical Department.

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.

DATABASE / NETWORK TAB:

This tab allows the access path to the database to be configured.


Reserved for use by the Technical Department.
When working with several instruments installed in network, it is possible
to filter samples by instrument number from which they have been
analyzed, when starting the PHORESIS software, by selecting the
corresponding option.

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By double-clicking on the serial number of the instrument displayed in the


status bar, the following window is displayed on the screen:

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.

EDIT CURVES TAB:

Click on this tab to:

- use the mouse wheel to scroll along the curves in the display pane of
the review window,

- view the image of the electrophoretic migration constructed from the


optical density (OD) readings,

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- alter the inspection time when validating a curve,


PLEASE NOTE: A line indicated in bold in the worklist by table means
that the curve has not been viewed. The line will also remain in bold if it
has not been viewed for the whole time shown in the field.

- show the alerts in zone B of the review window that indicate that
aberrant values have acquired (see § 4.3.3.2. EDIT CURVES),

- overlay a pre-stored datum curve with the analysis program (see


§ 4.3.3.2. OVERLAY REFERENCE PATTERN MODE),

- enable patient history auto-search (see § 4.3.4.3 SEARCH FOR


KNOWN PATHOLOGICAL PATIENTS),

- delete patient history link during data storage or transmission,

- synchronize the IT bar code modes for all instruments that are
connected to the database.

4.3.1.2. PRINTER SETUP

This command allows to select the printer and to access to the printing
options.

4.3.1.3. CUSTOMIZE REPORT

Use this command to program and / or select the result report.


A "standard" result report (in English) is preset by default and is adapted
to each analysis program.
PLEASE NOTE: Check that the selected analysis program is shown in the
status bar (see § 4.3.3.4. CHANGE WORKING PROGRAM).

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Toolbar

Format editor

Results report setup


sheet

Label selection
bar

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Description of the result report setup toolbar:

ICONS FUNCTION

Opens a new blank result report

Opens the list of existing result reports

Saves the current result report

Copies the page setup of the selected result report to


another analysis program
Changes the text font

Text alignment

Sends to front or back

Changes the text colour

Click on the icon to open a default programming procedure.


The following window will then open:

SELECT THE DEFAULT REPORT:

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
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image and quantitative results on a separate page), compressed printout

(Standard English Multi) and anteriority. Click on the buttons to


select the result report type for each mode.

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.

THE FORMAT EDITOR


A window will open allowing to configure the logo, the curve, the
electrophoretic pattern or the fractions table after a right click on the
mouse of the corresponding element. Use this window to change the size,
headings, fonts, axis graduation printing ... of the selected label.

THE LABEL SELECTION BAR

- click on the button to select a field to add to the result report sheet,

- click on the button to confirm the selected field,

- the field will appear at the top of the result report after confirmation. To
move the label to another position, click and drag,

- click on the button to delete a field.


To change the name and the size of a label, click on the label and enter
the new information at the bottom of the screen.

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4.3.1.4. EXIT

Use the exit command to close the PHORESIS software before shutting
down the PC.

The PHORESIS software can also be closed by clicking on the icon


after a cycle of extinction of the instrument.
To shut down the PC from Windows:

- 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:

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4.3.2. "WORKLIST" MENU

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).

4.3.2.1. WORKLIST BY SINGLE SHEET

Use this command to enter patient data to a card.

Clicking on the icon will also activate this command.


When this command has been selected, a dialogue box will open to enter
the number of the first sample.
Once this number has been entered, the first patient card will appear,
ready to be filled in.
NOTES:

- 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).

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Particular case: NEONAT Hb analysis program
With the NEONAT Hb analysis program, the patient card presents the
following additional data fields: Segment barcode, Punch date, Sample
data, Hb pattern and Interpretation of ratios.

Description of data fields in the dialogue box:

DATA FIELD FIELD ATTRIBUTES


Name Alphanumerical (max. 30 characters)
Sex Text (M, F or "_")
Date of birth Numerical (mm/dd/yy, mm/dd/yyyy)
Numerical (calculated automatically if the
Age
date of birth is entered)
Department Alphanumerical (max. 50 characters)
ID Alphanumerical (max. 30 characters)
Sample date Numerical (mm/dd/yy, mm/dd/yyyy)
Concentration (total Numerical. To change the unit of
protein) concentration, see § WORKLIST FIELDS.
Segment barcode Alphanumerical (max. 8 characters)
Punch date Numerical (mm/dd/yy, mm/dd/yyyy)
Sample data Alphanumerical (max. 20 characters)
Hb Pattern Automatic interpretation of the
electrophoretic pattern
Interpretation of ratios Automatic interpretation of the ratio

CAUTION: To prevent any input error, dates of birth prior to 1930


should be entered in the mm/dd/yyyy format.

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Description of the buttons in the dialogue box:

BUTTONS FUNCTION

New Creates a patient card


New No. Allows a new sample number to be entered
<< Brings up the first patient card in the list
< Brings up the previous card
> Brings up the next card
>> Brings up the last card
Options Brings up the "Worklist fields" dialogue box
Saves any changes and closes the active
Close
window

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.

This window can be used to activate:


- the fields to be used and to define names for the free fields ("Field
title…" button),

- the print setup of fields in the worklist ("Print options …" button),
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- the department code, which allows the automatic replacement of a


department code by the name of the corresponding department (see §
4.3.8.2.9. DEPARTMENT LIST) in the worklist by table,

- the concentration unit of fractions within each analysis program

selected by using the drop-down list (with the URINE analysis


program, the concentration unit is by default in g/24 h ; another unit
can be selected and it will then be displayed in the "Conc." zone from
the review window instead of the g/24 h unit),

- 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,

- the update of the patient history table after each change.

"Check duplicated ID" option


If a file number is detected by the bar code reader and when the "CHECK
DUPLICATED ID" option has been selected, a dialogue box will open to
indicate when a duplicate number has been entered.
PLEASE NOTE: File numbers can be entered using their corresponding
bar code.
The file number matches the bar code when it is on the primary sample
tube. If there is no bar code, the patient data for the sample is added to
the end of the worklist. Only information relating to the position of the
primary sample tube and the bar code number of the sample rack are
shown in the "Name" field in the worklist. It is not, therefore, strictly
necessary for the tubes to have a bar code.

"Enable department coding" option


If information has been entered into the Department table (see § 4.3.8.2.9.
DEPARTMENT LIST) and the "ENABLE DEPARTMENT CODING"
command has been selected, the user can enter an alphanumerical code,
which will enter the related department name automatically.

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"Auto refresh downloaded department code" option
If the PHORESIS software is connected to the host computer system, the
downloaded department code will automatically be replaced by the
department name.
This option can be activated only when the preceding "Enable department
coding" option is activated.

"Enable age calculation" option


This option allows to enable the automatic age calculation of a patient
according to his birth date and the sample collection date.

Sample display options


This option allows to activate the visualization in the worklist by table
samples validated, suspended or with anteriority and with pathological
anteriority. In the worklist by table, the line of the corresponding sample is
colored.

Pending samples
This option allows to display pending samples at the top or at the bottom
of the working list.

4.3.2.2. WORKLIST BY TABLE

Use this command to enter patient data into a table at the current date.

Clicking on the icon will also open this command.


The data fields are the same as those in the "worklist by single sheet"
command (see § 4.3.2.1. WORKLIST BY SINGLE SHEET).
In order to enter the patient's data, left click on the field and enter the
information.

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IT list

Tube bar code


mode
Sample rack bar
code mode

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.

With the HbA1c analysis program, the worklist contains additional


columns:

- The "Profil info" column contains small electrophoretic patterns which


color depends on the result of the analysis:

- an atypical pattern is represented by a magenta curve,

- a pattern with elevated HbA1c level is represented by an orange


curve,

- a pattern defined as pathological by the operator is represented by a


red curve,

- an atypical and pathological pattern is represented by a magenta


curve and a red curve,

- a pathological pattern with elevated HbA1c level is represented by an


orange curve and a red curve,

- a pattern with normal HbA1c concentration is not represented by a


small pattern.

- the "mmol/mol" and "cal %" columns indicate the obtained HbA1c
concentrations in these 2 units,

- the "Pathological" column indicates the samples that have been


marked as pathological by the operator in the "Pathological" zone of
the review window,

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- 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 NEONAT Hb analysis program, the worklist contains additional


columns:
- the "Segment barcode" column indicates the number of the barcode
that is printed on the dilution segment,
- the "Punch Date" column indicates the date of the punching of the
filter paper that contains the blood sample from newborn,
- the "Sample Data" column indicates additional information about the
sample collection,
- the "Pathological" column indicates the samples that have been
identified as pathological by the operator in the "Pathological" zone
from the review window,
- the "Hb pattern" column indicates the result of the automatic
presumptive interpretation of the electrophoretic pattern,
- the "Interpretation of ratios" column indicates the result of the
automatic presumptive interpretation of ratios calculation.

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

then displayed in the "Conc." zone from the review window ( ).

Description of the buttons in the dialogue box:

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

Print Prints a copy of the worklist by line number

Options Brings up the "Worklist fields" dialogue box (see

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BUTTONS FUNCTION
§ 4.3.2.1. WORKLIST FIELDS)

Deletes the sample indicated by an arrow in the left-


Delete
hand column

Delete Deletes all samples in the range entered in the


from…to… dialogue box

Move Moves the data relating to one or more samples

HYDRAPLUS/ Downloads the bar codes read by HYDRAPLUS or


ASSIST. ASSIST to the worklist

Displays the immunotyping requests in the IT list


(only available for the PROTEIN(E) 6 and
IT List
IMMUNOTYPING 6 analysis programs)
or
Displays the analysis requests in the Hb list (only
Hb List
available for the Hb and Hb A1c analysis programs)
or
Displays the analysis requests in the CDT / IS list
CDT / IS List
(only available for the CDT and CDT / IS analysis
programs)

The analyses can be sorted according ascending or


Sort
descending order of each column

NOTE: Samples in a column may be shown in ascending order by clicking


on the column header. To show the samples in the table in descending
order, repeat as above while holding down the "Ctrl" key.

Description of the "HYDRAPLUS/ASSIST." button:


The HYDRAPLUS and ASSIST instruments include an integrated bar
code reader that can download the bar code list to the PHORESIS
worklist.
The bar code reader can be connected to the PC by a cable connecting
the Connec. PC socket on the HYDRAPLUS or ASSIST instrument to
COM port 2 on the PC.

After a click on the "HYDRAPLUS/ASSIST." button, the following dialogue


box will appear:

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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.

Description of the "IT LIST" button:


Click on the "IT LIST" button to display the immunotyping requests
obtained from the PROTEIN(E) 6 and URINE analysis programs, which
have not yet been treated (see ZONE R: IT REQUEST).

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).

- Using the IMMUNOTYPING 6 and URINE analysis programs: once the


samples have been analyzed using immunotyping, they disappear from
the IT list and are transferred to the worklist by table. The IT list is
updated automatically after each IT analysis.

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- Clicking again on "IT list" button will close the window corresponding to
the IT list.

Description of the data fields in the "IT list":

DATA FIELD FIELD ATTRIBUTES

Since Date the immunotyping request was made (IT)

Date the analysis was performed using the


Date
PROTEIN(E) 6 or URINE analysis programs

Code of the analysis program used (see


P
§ 4.3.8.2.1. ANALYSIS PROGRAMS)

No. Number of the tested sample

Selected dilution mode (see the SEBIA


CAPILLARYS or MINICAP IMMUNOTYPING kit
instructions for use).

Dilution The dilution mode can be changed by clicking in

the dilution field and on the drop-down list ( )


(Hypogamma, Standard, Hypergamma or
Optimized)

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

NOTE: The chronological or alphabetical order of the IT list can be


changed by clicking on the data fields.

Description of buttons in the "IT list":

BUTTONS FUNCTION

Adds an immunotyping request with a new bar


Add
code entry

Updates information in the IT list following a new


Refresh
IT request

Print Prints the IT request

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BUTTONS FUNCTION

Delete Erases an IT request

4.3.2.3. PRINT WORKLIST

Use this command to print the worklist table either in part or in full, by
sequence number.

Insert the range of sample numbers to be printed in the "Print list"


dialogue box or enter * to print all samples.

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.

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4.3.3. "EDIT CURVE" MENU

Select this menu to access the following commands:


- display detected curves as a series of tiles (mosaic),
- alter a curve in the selected analysis program,
- display patient fraction results for the selected analysis program and print a
summary chart,
- select an analysis program,
- print the results of the selected analysis program,
- program the print order for the results,
- compressed printout of the results.

4.3.3.1. CURVES PREVIEW (MOSAIC)

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.

Clicking on the icon will also activate this command.


Pagination

Profile number

Bar code number

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The color of the electrophoretic patterns shows the following:

- blue : known sample (identified fractions),

- purple : unknown sample (unidentified fractions),

- red : sample flagged as pathological.

To move between series of samples:

- click on the icon to go to the next page,

- click on the icon to go to the previous page.

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.

SPECIAL FEATURE: IMMUNOTYPING 6 and IMMUNOTYPING URINE


analysis programs
The tile format window of the IMMUNOTYPING 6 or URINE analysis
programs includes 7 profiles per line and additional buttons that bring up
the IT window in one click (see § 5.1.3.2. ZONE R: SEE IT).
To view an IT analysis, click on the IT window display button.

IT window
display button

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NOTE: Each profile is identified by the name of the immunofixation
reagent that was used, ELP, Ig G, Ig A, Ig M, K or L (see the SEBIA
CAPILLARYS or MINICAP IMMUNOTYPING kit package insert).

SPECIAL FEATURE: CDT analysis program


The tile format window of the CDT analysis program includes 7 profiles
per line.

NOTE: For the normalized profiles with the Normal CDT Control, a "N"
label is displayed on the right top of the electrophoretic pattern.

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4.3.3.2. EDIT CURVES

Use this command to bring up the curve processing review window for the
current analysis program.

Clicking on the icon will also activate this command.

ZONE A: THE GRAPH

The colour of the curve shows the following:

- blue : known sample (identified fractions),

- purple : unknown sample (unidentified fractions),

- red : sample flagged as pathological.


NOTE: Scroll through the curves using the mouse wheel: see § 4.3.1.1.
EDIT CURVES TAB.

According to the analyzed sample, on the right top of the A zone


these 3 icons can be found. The first one (green background) is
the name of the technique. The second one (yellow or orange
background) indicates if the sample is a control sample. The
3rd icon (blue background) is displayed if the sample is marked as QC.

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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.

SPECIAL FEATURE: CDT, URINE and IMMUNOTYPING URINE


analysis programs
With these 3 analysis programs, the operator can select the
representation mode of the curves from the two following ones (displayed
in the right upper part of the zone A):

- "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.

MINIMUM MODE (default mode when the review window is open)

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.

ZONE B: FRACTION VALUES

Up to 10 fractions and their corresponding values in %, concentration or


integral can be displayed in this zone.
The percentages of identified fractions are automatically calculated.
Passing the mouse cursor over the results displays an icon information
that indicates minimal and maximal values for each fraction.

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NOTES:

- 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.

- With the NEONAT Hb procedure, the results for hemoglobin fractions


can be expressed according to 2 modes of fraction quantification:
"absolute quantification" (by default) that corresponds to the
percentages of fractions compared to the area under the curve or
"quantification at 100 %" that corresponds to the percentages of
fractions compared to the total amount of all fractions.
Please contact the Technical Department for the installation of the
"Enable quantification of the peaks at 100%" option.

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).

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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.).

Click on the button to display a dialogue box that allows to


select the fraction name identification table corresponding to the current
analysis program, the table for standard values in percentages and the
table for standard values in concentrations (see § 4.3.8.2.3. NORMAL
RANGE IN %, § 4.3.8.2.4. NORMAL RANGE IN CONC. and § 4.3.8.2.6.
FRACTION NAME IDENTIFICATION TABLE).

SPECIAL FEATURE: NEONAT Hb program


With the NEONAT Hb analysis program, the "Hb pattern" field

displays the result of the automatic presumptive


interpretation of the electrophoretic pattern, based on the detection of
identified peaks (Hb A, Hb F, etc…), of supposed peaks (Hb S zone, Hb C
zone, etc…) and according to the ascending order of the percentages of
the fractions.
WARNING: This information is only an aid for interpretation.
The automatic interpretation is not performed on the patterns from control
samples or on non-zoned patterns.
The "Enable automatic Hb pattern detection" option

( ) is activated by default for the NEONAT


Hb analysis program and is located in the "Display parameters (2/2)"
window; it is inactivated for all other procedures.
This presumptive interpretation may be deactivated and it is possible to
enter manually a new interpretation. In that case, a list of predefined
Hb patterns is accessible and can be modified from the same "Display
parameters (2/2)" window and using the "Edit Hb pattern list" button
( ).

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Use the fields and the buttons from this window to enter new Hb patterns,

to delete ones, or to change their order ( ).


The manual interpretation of the Hb pattern may be performed by

selecting a new interpretation using the drop-down list . The transfer


towards the work list is automatic and immediate. When the result table is
already open, it is necessary to refresh it to get the update.
The automatic Hb pattern and manual Hb pattern are identified by the
color of the cell. For a green cell, the interpretation is automatic. For a
white cell, the interpretation is manual.

ZONE C: RATIO SETTINGS AND TOTAL PROTEIN CONCENTRATION

Ratio 1 and Ratio 2 are set in UTILITIES / CUSTOMER


CONFIGURATION / RATIO SETTINGS.
The total protein concentration level appears after this value has been
entered in the "conc." column of the worklist by table section or after the

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).

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SPECIAL FEATURE: URINE analysis program
With the URINE analysis program, the "conc." field in zone C

( ) indicates the sample protein concentration (the unit


concentration – g/l or g/24h – may be selected by the operator in the

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).

SPECIAL FEATURE: NEONAT Hb analysis program


With the NEONAT Hb analysis program, the "conc." field is replaced by a

field that indicates the A/F and A/X ratios ( ) with X =


S, C, E or other Hb.
The automatic presumptive interpretation of ratios can be visualized in an

icon information by passing the cursor on the button from a ratio field

( for example); this button is displayed only in the case of


effective manual or automatic interpretation. The displayed "Interpretation"
table presents the results of this interpretation:

ZONE D: CURVE SELECT BUTTONS

Use the select buttons to bring up the next curve ( ), the previous curve

( ), and the first or last curve ( and respectively) in the sequence.


CAUTION: Changes made to a curve will be saved after a switch to
another curve using the select buttons.

However, changes made to a curve can be undone using the button.

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ZONE E: COMMENTS

A comment can be added from the keyboard or selected from a


predefined list set up by the user (see § 4.3.8.2.2. COMMENT LISTS).
To add a comment from the keyboard, click on the "Comments" field and
type in the text (no more than 230 characters).

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"

command and then on the drop-down list to select the required

comment. Click on the button to add more comments.

Once a comment has been added, the icon becomes .

NOTE: Carry out a comment search (see § 4.3.4.1. COMMENT SEARCH)


to find all samples with the same comment.

ZONE F: ATTACHED CARD

The attached card included with each electrophoretic pattern enables


users to bring up the quantitative specific protein, extra comments and the
scanned immunofixation image.
To activate the attached card, check the box in the "Card" option.
NOTE: The attached card can be activated only if the patient’s name has
been entered.
To bring up a patient’s attached card, click on the "View" button.

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The fields where the concentrations are entered are all in the "Protein
values" box.
To enter these data, click on the field that matches the concentration and
enter the appropriate data (no more than 10 characters).
To add a comment, click on the "Comments" field and type in the text.
To add a comment from a list, click on the "Comments" button and select
the required predefined comment.
To import a comment from a comment list, click on "Comment lists", and
then click on the comment to import.

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.

- To save a comment or change a predefined comment, see § 4.3.8.2.2.


COMMENT LISTS.

Descriptions of buttons in the dialogue box:

BUTTONS FUNCTION

Copies the contents of the image area to the


clipboard

Pastes from the clipboard to the image area

Deletes the contents in the image pane

Comments Used to add a predefined comment

Used to configure headings, units of


Options concentration and normal value ranges on the
detailed card

Prints a copy of the attached card (to be


Print
configured in the result report)

Saves any changes and closes the active


Close
window

NOTE: For instructions on managing immunofixation images, see §


5.1.7.1. MANAGING IMMUNOFIXATION IMAGES.

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ZONE G: PATHOLOGY

To flag a sample as pathological, click on the "Pathological curve" option.


The graph inside zone A will then be flagged as PATHOLOGICAL in red.
The curve is then displayed in red.
NOTE: The "Pathological curve" option will only be active if the name of
the patient has been previously entered.
Use the search by function option (see § 4.3.4.1. SEARCH FOR PATIENT
HISTORY) to search all the pathological curves.

ZONE H: PEAKS

This option can be used to integrate up to ten curve areas without


affecting the results given in zone B.
To integrate a peak:

- click on the button (peaks quantification),

- left click, keep pressed in and move the cursor over the part of the
curve to integrate.

After peak identification, a label (or a number) and a value in percentage


are displayed in the zone H. It is possible to see the entire name of a
fraction, if the field is not large enough to accommodate the display, by
passing the mouse cursor over this field. Information will be displayed
containing the whole name of the fraction.

- View the relative value by clicking on the button ; the relative


value is calculated from the areas that were integrated.

- View the absolute value by clicking on the button ; the absolute


value is calculated from the results in zone B.

- Click on the button to show this in g/L or g/dL (if the protein
concentration is known).

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- Click on the button to show in percentage.


To alter the name of the region, click on the field with the region’s
identification number and enter a new name (no more than
10 characters).

To alter the integration area, click on the button ("from bottom to top"

integration) or on the button ("valley to valley" integration).

NOTE: To integrate a second peak, click on the button again and


follow again the procedure.
To delete a region, click on the field with the identification number or

name of the region to delete, and then click on the button.


To identify and to integrate automatically the peaks of the curve, click on

the button.
NOTE: The button is gray-dashed when it is inactive.

When a result report is printed, the name, percentage and concentration


will be shown in the fraction chart.

SPECIAL FEATURE: URINE ANALYSIS PROGRAM

The "Quantify peaks" button ( ) allows to select the "Urine ratio" or


"Peak quantification" function from the corresponding button

.
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

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the concentration are not active on integrated peaks using the "Ratio
urine" function.

For peaks quantification, abnormal peaks must be manually integrated


using the "Peak quantification" button.
Two integration modes are proposed to the operator: "valley to valley"
integration or "from bottom to top" integration. The selection of the
integration mode is based on the electrophoretic pattern feature (position
of the peak of interest in relation to the baseline) and according to usual
procedures of the laboratory.
For a quantified peak, results are indicated:
- in percentages or,
- in concentrations in g/dL or g/24 hours (in that case, urinary protein
concentration of the sample must have been previously entered in the
work list).
The integrated peaks are displayed in the "Peaks" zone and are called #1,
#2…; they are not considered for the Ratio urine calculation.
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 the concentration are active on integrated
peaks using the "Peak quantification" function.

See the SEBIA CAPILLARYS / MINICAP URINE kit package insert.

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SPECIAL FEATURE: CDT analysis program
As soon as the analysis is complete, transferrin isoforms peaks are
automatically integrated, automatic computation of CDT (Carbohydrate
Deficient Transferrin) is shown in the RESULTS parts of the window
(zone B) and in the zone H.
NOTE: During the analysis of the Normal CDT Control, identified with its

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.

SPECIAL FEATURE: HEMOGLOBIN(E) analysis program


At the end of the analysis, relative quantification of individual hemoglobin
fractions is performed automatically and shown in zone H when the option
"enable automatic quantification" is selected.
To facilitate the interpretation of the hemoglobin electrophoretic patterns,
the hemoglobin fractions, Hb A, Hb F and Hb A2 are automatically
identified and the Hb A fraction is adjusted in the middle of the review
window. The resulting electrophoregrams are evaluated visually for
pattern abnormalities.
The potential positions of the different hemoglobin variants (identified in
zones called Z1 to Z15) are shown on the screen of the system and
indicated on the result ticket. See the SEBIA CAPILLARYS or MINICAP
HEMOGLOBIN(E) kit package insert where variants which may be
present in each corresponding zone are listed.
When the software identifies a hemoglobin fraction in a defined zone, the
name of this zone is framed.
Patterns are automatically adjusted with regard to Hb A and Hb A2
fractions to facilitate their interpretation:

- when Hb A and / or Hb A2 fractions are not detected on an

electrophoretic pattern, a yellow warning signal appears, the


adjustment is performed using the position of the Hb A fraction on the
two previous patterns obtained with the same capillary ; then, there is
no fraction identified (except when Hb C is detected: in this case,
Hb A2 and Hb C fractions are identified) ;

- when Hb F is detected on an electrophoretic pattern, without any


detection of Hb A, the yellow warning signal does not appear, the
adjustment is then performed using the position of the Hb F fraction,
and Hb F and / or Hb A and / or Hb A2 fractions are identified ;
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- when the adjustment is not possible, a red warning signal


appears, Hb F and Hb A2 fractions are then not identified (call the
technical department) ;

- when optical density (OD) is insufficient on a migration control


electrophoretic pattern (obtained with the Normal Hb A2 Control
identified with its bar code label and analyzed on the sample rack No. 0
or F0 or in position No. 28 from a rotating sampler), a warning
message is displayed in order to consider or remove this analysis for
the determination of Hb A fraction position. Then, a purple warning

signal appears on the review window and Hb A and Hb A2


fractions are not identified.

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 symbol present on the profile indicates an impossibility of


centering the profile.
See the SEBIA CAPILLARYS or MINICAP HEMOGLOBIN(E) kit package
insert.

SPECIAL FEATURE: NEONAT Hb analysis program


At the end of the analysis, electrophoretic patterns can be analyzed. The
relative quantification of individual hemoglobin fractions is performed
automatically and shown in zone H when the option "enable automatic
quantification" is selected.
To facilitate the interpretation of the hemoglobin electrophoretic patterns,
the hemoglobin fractions, Hb A, Hb F and Hb A2 are automatically
identified and the Hb F fraction is adjusted at a well-defined position of the
review window. The resulting electrophoregrams are evaluated visually for
pattern abnormalities.
The potential positions of the different hemoglobin variants (identified in
zones called N(C) to N(Bart)) are shown on the screen of the system and
indicated on the result ticket. See the SEBIA CAPILLARYS NEONAT Hb
kit package insert where variants which may be present in each
corresponding zone are listed.
When the software identifies a hemoglobin fraction in a defined zone, the
name of this zone is framed.

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Patterns are automatically adjusted with regard to Hb F fraction to
facilitate their interpretation:

- when Hb F fraction is not detected on an electrophoretic pattern, a

yellow warning signal appears, the adjustment is performed using


the position of the Hb F fraction on the previous pattern obtained with
the same capillary ;

- when the adjustment is not possible, a red warning signal appears


(Call the technical department) ;

- when optical density is insufficient on a migration control


electrophoretic pattern (obtained with the Hb AF Control, identified with
its bar code label on the sample rack No. 0), a warning message is
displayed in order to consider or remove this analysis for the
determination of Hb F fraction position. Then, a purple warning signal

appears on the review window and Hb A, Hb A2 and Hb F


fractions are not identified.
In all cases, the different migration zones (N(C) to N(Bart)) do not appear
neither on the screen of the system, nor on the ticket result and patterns
are grey dashed.

The symbol present on the profile indicates an impossibility of


centering the profile.
See the SEBIA CAPILLARYS NEONAT Hb kit package insert.

SPECIAL FEATURE: CORD BLOOD analysis program


At the end of the analysis, relative quantification of individual hemoglobin
fractions is performed automatically and shown in zone H when the option
"enable automatic quantification" is selected.
To facilitate the interpretation of the hemoglobin electrophoretic patterns,
the hemoglobin fractions, Hb A, Hb F and Hb A2 are automatically
identified and the Hb F fraction is adjusted at a well-defined position of the
review window. The resulting electrophoregrams are evaluated visually for
pattern abnormalities.
The potential positions of the different hemoglobin variants (identified in
zones called C1 to C12) are shown on the screen of the system and
indicated on the result ticket. See the SEBIA CAPILLARYS
HEMOGLOBIN(E) kit package insert (part "CAPILLARYS CORD BLOOD
procedure") where variants which may be present in each corresponding
zone are listed.

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When the software identifies a hemoglobin fraction in a defined zone, the
name of this zone is framed.
Patterns are automatically adjusted with regard to Hb F fraction to
facilitate their interpretation:

- when Hb F fraction is not detected on an electrophoretic pattern, a

yellow warning signal appears, the adjustment is performed using


the position of the Hb F fraction on the two previous patterns obtained
with the same capillary ;

- when the adjustment is not possible, a red warning signal


appears, Hb A, Hb F and Hb A2 fractions are then not identified (Call
the technical department) ;

- when optical density is insufficient on a migration control


electrophoretic pattern (obtained with the Hb AF Control, identified with
its bar code label on the sample rack No. 0), a warning message is
displayed in order to consider or remove this analysis for the
determination of Hb F fraction position. Then, a purple warning signal

appears on the review window and Hb A, Hb A2 and Hb F


fractions are not identified.
In all cases, the different migration zones (C1 to C12) do not appear
neither on the screen of the system, nor on the ticket result and patterns
are grey dashed.

The symbol present on the profile indicates an impossibility of


centering the profile.
See the SEBIA CORD BLOOD procedure package insert.

ZONE I: ELECTROPHORETIC IMAGE

The electrophoretic image is a view of the migration image constructed


from the optical density (OD) readings (see § 4.3.1.1. EDIT CURVES
TAB).

ZONE J: PATIENT DATA

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:

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To alter the data, click on the icon (see § 4.3.2.2. WORKLIST BY

TABLE) or on the icon (see § 4.3.2.1. WORKLIST BY SINGLE


SHEET).
NOTE: If the worklist has been filled with data, without closing the curve
review window before, updating the patient's data in this window would be

done after clicking on the icon (in the zone V).

ZONE K: PROGRAM, OPERATOR, INSTRUMENT

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 N: VALIDATED SAMPLE

By default, the sample is not validated.


To validate an electrophoretic pattern, see § 4.3.8.2.8. DISPLAY
PARAMETERS, where the "Validation mode" must be activated in the
"Editing window" zone. In this current window, in the "Validation" section
of the "Mosaic" zone, it is possible to display the state of the pattern by
clicking on "Do not display", "Display validated curves" or "Display non
validated curves". The state of the pattern will then be displayed on the
mosaic (with the identification number of the sample on a green
background for a validated sample, for example).
After a click on the zone, that sample can be suspended: "pending
since…" will then be displayed (see § 4.3.4.5. SEARCH FOR PENDING
SAMPLES).
NOTE: Pending samples are not sent to the LIS (laboratory information
system) system.

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With the IMMUNOTYPING 6 procedure, it is possible to validate the
6 electrophoretic patterns of the immunotyping in only one operation from
the IT window and using the validation button.

ZONE O: REAGENTS

Zone O shows the lot number and expiry date of the reagents entered by
the operator.

ZONE P: CURVE OPTIMIZATION (TRIGLYCERIDE INTERFERENCE


ELIMINATION)

NOTE: The curve optimization by triglyceride interference elimination can


be performed only with the PROTEIN(E) 6 program.
When using the PROTEIN(E) 6 analysis program, the curve optimization
may be performed by triglyceride interference elimination that are located
between albumin and alpha-1 fractions.
There are two options:

- 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.

- Standard: the option "Optimize" is not available and triglyceride smear


appears between albumin and alpha-1 fractions. The unmodified curve
is shown in zone A.

ZONE Q: SAVE AND EXIT

Clicking on this icon will save any changes made to the review window
and then close it.

ZONE R: IT REQUEST (IMMUNOTYPING REQUEST)

Only visible for PROTEIN(E) 6 and URINE analysis programs.


Select this option to run an immunotyping request on a sample tested
using the SEBIA CAPILLARYS or MINICAP PROTEIN(E) 6 or
CAPILLARYS / MINICAP URINE kit (see § 4.3.2.2. WORKLIST BY
TABLE).

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With the PROTEIN(E) 6 analysis program (on CAPILLARYS instruments


for example), selecting this option leads to the following dialogue window:

With the URINE analysis program (on CAPILLARYS instruments for


example), selecting this option leads to the following dialogue window:

Refer to the SEBIA CAPILLARYS or MINICAP IMMUNOTYPING kit


instructions for use to select the recommended dilution mode.
PLEASE NOTE: In the URINE technique, the dilution to perform is
automatically suggested and depends on the value of the "Urine ratio"
parameter (see the CAPILLARYS / MINICAP URINE kit package insert).
After a click on the "OK" button, the dilution that has been selected will be
confirmed (see § 4.3.2.2. WORKLIST BY TABLE).
This will automatically update the IT list by adding the concerned patient’s
data.
Once the instrument is set on IMMUNOTYPING 6 or IMMUNOTYPING
URINE analysis program (depending if the IT request has been made in

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PROTEIN(E) 6 or URINE program), if a sample is analyzed and identified
(via its bar code) as coming from a patient which is in the IT list, this
sample will be treated and the patient’s data will be removed from the IT
list.
A link will be done between the analysis which has been done in
IMMUNOTYPING 6 technique and the original analysis (in PROTEIN(E) 6
ou URINE tehnique). The "See IT" button would then be activated.
Two modes are available to identify the patients which are in the IT list:

- 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.

SEE IT (Displays the immunotyping profiles)

Only visible for the IMMUNOTYPING 6, PROTEIN(E) 6, URINE and


IMMUNOTYPING URINE analysis programs.
Select this option to view protein profiles and related comments in the IT
window.

IT window that can be seen in


IMMUNOTYPING 6 and PROTEIN(E) 6 analysis programs

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IT window that can be seen in


IMMUNOTYPING URINE and URINE programs
(with identification of Albumin, Alpha 1, Alpha 2, Beta and Gamma zones)

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.

Superimpose (activated by default)


To stop the ELP curve from being laid over each antiserum profile,
uncheck the overlay box.

Date
Shows the date on which the immunotyping analysis was performed.

Dilution
Shows the dilution mode that has been selected for the IT analysis.

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Zoom
Use the zoom mode to magnify the IT profiles an infinite number of times
(see § ZOOM MODE).

Validation button

The validation button allows to validate the


6 electrophoretic patterns of the immunotyping in only one operation from
the IT window. After having validated the 6 patterns, the button becomes

and the state of the pattern will then be displayed on the


mosaic (with the identification number of the sample on a green
background).

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.

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After a click on the "Start Search" button, the following dialogue box will
appear:

Description of the dialogue box buttons:

BUTTONS FUNCTION

Print highlighted sample Prints the curve displayed on the graph

Matches the IT curves to the protein


Select this sample
curve

Print all previous samples Prints the curves of each sample

Animation Displays the curves automatically

Close Closes the window

Select the curve from the "PREVIOUS SAMPLES" box that is to be


matched to the IT curves, then click on "Select this sample".
Click on "Yes" to confirm the link.

Print

To print the IT window, click on the button.

The select buttons

Use the select buttons to bring up the 6 next IT curves , the previous

curves and the first or last curves in the sequence ( and


respectively).

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Comments
By default, the extra comment entered in the IT window will automatically
be brought over to the PROTEIN(E) 6 program (in the extended
comments). To have the extra comment entered in the IT window
automatically brought over to the IMMUNOTYPING 6 program, select the
"to ELP curve" option.

To have the comments entered for the patterns (ELP, Ig G, Ig A, Ig M,


Kappa and Lambda) automatically brought over to the IT window, click on
the "IT comment compilation" option.

VISUALIZATION OF THE IT DILUTION

Only visible for the IMMUNOTYPING 6 and IMMUNOTYPING URINE


programs, also with PROTEIN(E) 6 and URINE programs when the
IT curves have been matched to the protein curve.

CURVE PROCESSING ICONS


The curve processing icons can be found in two toolbars placed above
and below the graph (zone A).

ZONE U: TOOLBAR ABOVE THE GRAPH

ZOOM MODE

Use the zoom mode to magnify the profile an infinite number of times. To

zoom, click on the button and then on the graph. To magnify by a


factor 4, left click the mouse. Clicking on the right mouse button will
reduce the profile magnification by the same factor. The curve
magnification factor is shown above the graph.

To return to the normal display size, click on the button.


To display a section of the magnified profile, move the cursor over the
area to display while keeping the left mouse button pressed in.
It is possible to use the minimum mode in zoom mode in keeping the
"SHIFT" button pressed in (see § MINIMUM MODE).
NOTE: The printing of a magnified curve will show the curve as in the
screen. The zoom factor will not be displayed on the printed report.

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MANUAL BASELINE MODE

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.

CHANGE BASELINE SLOPE MODE

Use the change baseline slope mode to compensate for a shift.

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.

DELETE ARTIFACT MODE

Use the delete artifact mode to remove an artifact.

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.

DELETE ZONE MODE

Use the delete zone mode to remove part of the curve.

Click on the button and then click on each side of the part of the line
that is to be deleted.

SMOOTHING MODE

Use the smoothing mode to alter the smoothness of the curve.

Click on the button. This will open a dialogue box to enter a


smoothness level,

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or select a level by clicking on one of the curve smoothness buttons:

. The current curve smoothness level is shown in bold.

NOTES:

- The resolution becomes weaker as the smoothing level rises (fewer


points are used to represent the curve).

- Depending on the smoothing level used, a small difference can be


seen in the results.

- The smoothing mode is displayed in grey and is not available with the
NEONAT Hb procedure.

CAUTION: A too high smoothing level may decrease low monoclonal


peaks. A too low smoothing level may lead to artifactual peaks and
interpretation errors, without any clinical interest.

O.D./T% MODE

By clicking on the button, it is possible to alter the way the curve is


displayed by increasing the globulin fractions and reducing the albumin
fraction.
Clicking on the button a second time removes this format.

OVERLAY REFERENCE PATTERN MODE

By clicking on the button, it is possible to overlay a reference curve


that has been previously stored (see § 4.3.3.2. SAVE CURRENT CURVE
AS REFERENCE PATTERN MODE). Clicking on the button a second
time cancels the overlay.

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RESTORE ORIGINAL CURVE MODE

By clicking on the button, cancel ALL modifications that have been


made and restore the original curve.

PRINT CURRENT REPORT MODE

By clicking on the button, print the result report for the displayed
curve.

ZONE V: TOOLBAR BELOW THE GRAPH

START No. MODE

By clicking on the button, display the curve of a sample after having


entered the sample number in the dialogue box.

NOTE: This curve becomes the first sample of the series. To visualize the

previous samples, click on the icon again and enter the


corresponding sample's number.

CONCENTRATION MODE

By clicking on the button, display the concentration values for each


fraction in the "FRACTION VALUES" section. This function will only be
active if the total protein concentration is shown in the "Conc." section
(zone C).

INTEGRALS MODE

By clicking on the button, display the integral values for each fraction
in the "FRACTION VALUES" section.

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SAVE CURRENT CURVE AS REFERENCE PATTERN MODE

By clicking on the button, store the displayed curve as a reference


curve. To overlay this reference curve on another curve, see § 4.3.3.2.
OVERLAY REFERENCE PATTERN MODE.

MANUAL Y EXPANSION MODE

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 %.

Move the cursor button or type in the value.

After a click on the button, the new value will apply to all the curves.

QC MODE

QC Mode lets to store the displayed curve as a "quality control" reference


curve (see § 5.3. QUALITY CONTROL).
NOTE: The control values must have been previously defined (see §
4.3.8.1.2. SETUP CONTROL VALUES).

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

named (low, medium or high). Once marked as "QC", the icon is


displayed on the screen. To delete the QC sample or remove the QC
label, select the QC icon on the edit curves screen, when the sample is
already labeled as QC.

The "NEW" button


Use this button to set the name of the control, the lot number, the number
of fractions, the total protein concentration, the unit of measure and the
control values (mean values and standard deviations).

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Once the selection has been confirmed, the annotation QC will appear in
zone A.

To cancel the QC mode, click on the button a second time.


NOTE: When a sample has been saved as "QC", only the following
functions remain available to the operator:

- zoom,

- save the current curve as a reference pattern,

- overlay the reference pattern.

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,

- the icon is pressed.

SPECIAL FEATURE: URINE PROGRAM


The review window displayed in the URINE analysis program is as
follows:

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The different protein zone positions (Albumin, Alpha 1, Alpha 2, Beta and
Gamma) are identified on the screen and on the result report, in order to
facilitate the identification of scanned fractions.
See the SEBIA CAPILLARYS / MINICAP URINE kit package insert.

SPECIAL FEATURE: HEMOGLOBIN(E) PROGRAM


The review window displayed in the HEMOGLOBIN(E) analysis program
is as follows:

The different expected migration zone positions are identified on the


screen.
Passing the mouse cursor over a zone name (Z…) displays icon
information containing possible hemoglobin variants that could be seen in
this zone. With the zoom mode, press the "SHIFT" button and pass the
mouse cursor over a zone name to display the icon information.
Only Hb A, Hb A2, Hb F and Hb C fractions are automatically identified
using a specific coloration (see the SEBIA CAPILLARYS or MINICAP
HEMOGLOBIN(E) kit package insert), whereas the other fractions are
grey dashed.

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SPECIAL FEATURE: NEONAT Hb PROGRAM
The review window displayed in the NEONAT Hb analysis program is as
follows:

The different expected migration zone positions are identified on the


screen.
In the case of automatic detection (or manual quantification of a fraction in
a specific zone), the name of this zone is framed.
Passing the mouse cursor over a zone name (N…) displays icon
information containing possible hemoglobin variants that could be seen in
this zone. For each fraction, the maximum position defines the migration
zone. With the zoom mode, press the "SHIFT" button and pass the mouse
cursor over a zone name to display the icon information.
Only Hb A, Hb F and Hb A2 fractions are automatically identified using a
specific coloration (see the SEBIA CAPILLARYS NEONAT Hb kit package
insert), whereas the other fractions are grey dashed.
NOTES:

- Information about the analysis, including the specific barcode of the


dilution segment, is indicated in the upper left corner of the review

window ( ).

- The detection of Hb Bart’s fraction can be improved by selecting the


"Bart’s high sensitivity detection" option from the "Display parameters

(2/2)" window ( ).

- An irremovable red disk that is specific for the NEONAT Hb


procedure, is displayed on the electrophoretic pattern in the upper right
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corner of the review window (and in the upper left part of the pattern in
the mosaic) to indicate that the sample has been marked as
pathological by the software. Passing the cursor on this disk leads the
display of an icon information "Detected pathological"
( ). This disk is not displayed on patterns that were
initially normal and marked as pathological by the operator and is not
displayed in the work lists, the result table and the result reports.

SPECIAL FEATURE: CORD BLOOD PROGRAM


The review window displayed in the CORD BLOOD analysis program is
as follows:

The different expected migration zone positions are identified on the


screen.
Passing the mouse cursor over a zone name (C…) displays icon
information containing possible hemoglobin variants that could be seen in
this zone. For each fraction, the maximum position defines the migration
zone. With the zoom mode, press the "SHIFT" button and pass the mouse
cursor over a zone name to display the icon information.
Only Hb A, Hb F and Hb A2 fractions are automatically identified using a
specific coloration (see the SEBIA CAPILLARYS HEMOGLOBIN(E) kit
package insert, part "CAPILLARYS CORD BLOOD" procedure), whereas
the other fractions are grey dashed.

WARNING: In the 3 cases previously described, the graduation of the


horizontal axis does not allow, in any case, the identification of a
hemoglobin variant.
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SPECIAL FEATURE: Hb A1c PROGRAM
The review window displayed in the HbA1c analysis program is as follows:

Only HbA1c, other Hb A, Hb A0 and Hb A2 fractions are automatically


identified using a specific coloration (see the SEBIA CAPILLARYS or
MINICAP Hb A1c kit package insert), whereas the other fractions are grey
dashed.

ZONE W: PATIENT HISTORY

Searching for patient history allows to display the previous analyses of a


patient. To do so, it is necessary to enter at least the patient name
and the date of birth.

Without any history, two icon informations are associated to the


according to the case:

- The icon information "Name field empty" is displayed when the


patient’s name is not indicated in the work list. After a click on this
button, the following dialogue box will appear:

- 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
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the work list. After a click on this button, the following dialogue box will
appear:

If a patient has a history, the search for patient history icon

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.

Descriptions of the buttons in the dialogue box:

BUTTONS FUNCTION

Print highlighted Prints a copy of the curve for the previous result
sample that has been selected

Creates a link between the sample of the current


Select this sample
date and the previous analysis

Print all previous Prints a copy of all previous results

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BUTTONS FUNCTION
samples

Automatically displays the curves and results of


Animation
previous samples

Close Closes the window

NOTE: In the worklist by table, the line of the sample with history is
colored in pink.

4.3.3.3. RESULT LIST

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:

- "mmol/mol" and % "cal" : these columns indicate the obtained HbA1c


concentrations in mmol/mol and in percentage,

- "HbA1c flags" : this column presents the number of flags (>) (or
alarms) displayed in the "Fraction values" zone of the review window
for HbA1c,

- "Profile info" : this column contains small electrophoretic patterns


whose color depends on the result of the analysis (magenta, orange,
red),

- "Fraction flags" : this column displays the alarms A2 (!) and F (!) that
correspond to samples with ß-thalassemia or samples with Hb F >
15 %, respectively.

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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:

- "Peaks" for the number of quantified peaks,


- "% peak 1 to 10" for the percentage of each quantified peak,
- "Conc. peak 1 to 10" for the concentration of each quantified peak,
- "Peak 1 to 10" corresponds to the name of the peak displayed in the
"Peaks" zone from the review window.

NOTE: The percentage and concentration of peaks reported in the result


table depend on the quantification mode ("valley to valley" or "from bottom
to top") selected in the review window. It is necessary to come back to the
mosaic and to close the review window before opening the result table in
order to take into account the selection done for the last viewed pattern.

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,

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- "Other Hb": this column reports the percentages of peaks that are
detected in zones that are not the zones of usual fractions, with an
indication of the name of the zone where the peak has been detected,
- "A/F" et "A/X": these columns report the values for Hb A / Hb F and
Hb A / Hb X ratios, in green (normal ratio) or red (abnormal ratio)
according to the reference values established by the operator (a ">" or
"<" symbol indicates the level of the ratio compared to the reference
values) or in blue in the case of the absence of established reference
values,
- "Hb pattern": this column indicates the result of the presumptive
interpretation of the electrophoretic pattern,
- "Interpretation of ratios": this column indicates the result of the
presumptive interpretation of the ratio calculation (cell with a green
color for an automatic interpretation or cell with a white color for a
manual interpretation).

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.

Description of the buttons in the dialogue box:

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)

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4.3.3.4. CHANGE WORKING PROGRAM

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.

4.3.3.5. PRINT REPORTS

Use this command to print the result reports for the analysis program that
was running on the date shown in the status bar.

It is also possible to run this command by clicking on the icon.


Print the results by entering the sample numbers in the "page range"
section in the PRINT dialogue box.
NOTE: It is possible to print the report in a PDF file format after having
selected "Print report to PDF file" in the following window:

SPECIAL FEATURE: IMMUNOTYPING 6 and IMMUNOTYPING URINE


analysis programs
The print results command can be used to choose either the special IT
mode print option (the 6 IT profiles are printed on the same paper sheet)

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or the standard print mode (one IT profile per paper sheet) when the
IMMUNOTYPING 6 and IMMUNOTYPING URINE analysis programs
have been selected.

4.3.3.6. CHANGE PRINTED REPORT ORDER

Use this command to print the result reports according to selected criteria
listed in the following window:

NOTE: Additionally, it is possible to print the result reports for pathological


samples by selecting "Pathological" and to print several result reports on
the same page by selecting "Summary report".

4.3.3.7. SUMMARY REPORT

Use this command to print several result reports (see § 4.3.1.3.


CUSTOMIZE REPORT).

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4.3.4. "SEARCH" MENU

Use this menu to carry out search operations in the stored curves.

4.3.4.1. SEARCH FOR PATIENT HISTORY

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.

This command can also be run by clicking on the icon.

There are 6 sections in this dialogue section:

INSTRUMENT

Use this function to select the instrument and its serial number from the

drop-down menu ( ).

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PROGRAM

Use this function to select the analysis program from the drop-down menu

( ) or by checking the "All the programs" section if the program is not


known.

SAMPLE TYPE

Use this function to narrow down the search to normal or pathological


samples, pending or not validated samples and with or without warning
signal, by clicking on the corresponding cell.
With the HbA1c procedure, the search may also be performed on samples
with atypical profiles or with an increased HbA1c value.
If the sample classification is unknown, the search must be made by all
samples.

COMMENT SEARCH

Use this function to select a comment type.


Click on the data field to type in the search string.

RANGE OF TIME

Use this function to select the search date or search period.

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.

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Performing the search
When the search criteria have been entered, click on the "Start search"
button.

Search results

- If the search is unsuccessful, the message "Sample not found" will


appear in the "SEARCH RESULTS" dialogue section.

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.

Description on the buttons in the "Search Results" dialogue box:

BUTTONS FUNCTION

Refresh Updates the data if changes are made in the review


window

Options Displays the work list fields

Close Closes the window

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BUTTONS FUNCTION

View Displays the curve of the selected sample

View all Displays all the curves, starting from the 1st sample that
has been found

Sort Sorts the records into alphabetical or chronological


order by the selected data field

NOTE: The curves of samples found in the database, and shown in


yellow, cannot be changed.

The icon will print a summary report of all the samples in the table or
print the worklist.

4.3.4.2. SEARCH FOR ABNORMAL CURVES

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).

4.3.4.3. SEARCH FOR KNOWN PATHOLOGICAL PATIENTS

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.

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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.

After a click on "Known pathological patient", the following dialogue box


will appear:

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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".

Descriptions of the buttons in the dialogue box:

BUTTONS FUNCTION

Prints a copy of the curve for the previous


Print highlighted sample
result that has been selected

Creates a link between the sample of the


Select this sample
current date and the previous analysis

Print all previous


Prints a copy of all previous results
samples

View card Shows the patient’s detailed card

Automatically displays the curves and


Animation
results of previous samples

Close Closes the window

NOTE: In the worklist by table, the line of the sample with history is
colored in pink.

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4.3.4.4. DELETE THE LABELS "KNOWN PATHOLOGICAL PATIENT"

Use this command to reset the database by erasing the flag indicating
patients with known pathological samples.

4.3.4.5. SEARCH FOR PENDING SAMPLES

Use this command to search for samples selected as having an


unsatisfactory result (see § ZONE N: VALIDATED SAMPLE). Once the
patient’s sample data have been blocked, they are automatically added to
the day’s worklist of samples to be analyzed (those samples are added to
the day’s worklist starting from number 20 000). To validate a sample,
analyze it again or click on the "pending since…" zone.

4.3.4.6. SEARCH FOR NON VALIDATED 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.

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Description on the buttons in the "Search Results" dialogue box:

BUTTONS FUNCTION

Refresh Updates the data if changes are made in the review


window

Options Displays the work list fields

Close Closes the window

View Displays the curve of the selected sample

Sort Sorts the records into alphabetical or chronological


order by the selected data field

The icon will print a summary report of all the samples in the table or
print the worklist.

4.3.4.7. UPDATE PATIENT HISTORY INFORMATION

Use this command to reset the database by updating the patient history
information.

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4.3.5. "DATABASE" MENU

This menu allows access to all the commands used to manage the stored data.

4.3.5.1. CHANGE WORKING DATE

When the PHORESIS software is opened, it displays the current date.

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.

4.3.5.2. VIEW DATABASE HISTORY

Use this command to show samples filed according to the date, the
analysis program and the instrument.

Clicking on the icon will also run this command.

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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

"Program" drop-down list ( ), select a program and then click on the


"<- Apply" button.
To view the curves that have been filed for another instrument, click on

the "Instrument" drop-down list ( ), select an instrument and then click


on the "<-Apply" button.
NOTE: In the fields "Program" and "Instrument", the asterisk (*) indicates
that all the programs or instruments installed in network are selected.
The last line in this dialogue box indicates the total number of samples
that have been saved.

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".

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Description of the buttons in the dialogue box:

BUTTONS FUNCTION

Deletes samples in the "normal curves"


Delete Normal curves
table for the selected date

Deletes samples in the "pathological


Delete Pathological tags
curves" table for the selected date

Select the working date of the normal


Change Norm. Date samples highlighted in the Normal Curves
table

Select the working date of the pathological


Change Path. Date samples highlighted in the "Pathol. Curves"
table

Display Atypical Select the working date of the samples

(HbA1c program) highlighted in the "Atypical profile" table

Display HbA1c Select the working date of the samples


increased highlighted in the "Increased HbA1c value"

(HbA1c program) table

Restore Date Shows the current date

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BUTTONS FUNCTION

Advanced save (see § 4.3.5.5.2.


Advanced Backup…
ADVANCED BACKUP)

4.3.5.3. DELETE SAMPLES

Use this command to delete the records from the backup.


To delete more than one record for the current analysis program at the
date displayed, enter the range of numbers of lines to be deleted.
CAUTION: The delete operation is irreversible.

4.3.5.4. MOVE SAMPLES

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.

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4.3.5.5. BACKUP

This command consists of the following options:

- Backup configuration (to configure save command),

- Advanced backup (advanced save).

There are two ways to back up the data:

- The "Backup configuration" option allows to save the complete


database.

- The "Advanced backup" option allows to select the analyses to save or


to restore by analysis program, year, month and day of analysis.

4.3.5.5.1. BACKUP CONFIGURATION

This option allows to save the complete database on a backup


device, to avoid any potential loss of data.
The data can be saved to a CD / DVD ROM, an external disk,
a network drive if the PC is networked or any adapted device.
In the "Database Backup location" field from the following
dialogue box, select the backup location from the drop-down

menu ( ) and determine the path.

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Select the days to make the backup by selecting the
corresponding days and enter the time of the backup in the
"Select the days and time to make the backup" section.
Enter the number of days from which the analyses must be
saved in the "Enter the number of days of backup".
IMPORTANT: The back up of data must be launched only
when the automated instrument is switched off and when
no operator is working on the database.
Contact the SEBIA Technical Department to restore data that
have been saved using this option.

4.3.5.5.2. ADVANCED BACKUP

The "Advanced Backup" window gives access to the Backup


samples or Restore samples operations.
NOTE: The assays to backup or to restore may be selected by
analysis program, year, month or day and by the type of the
sample (normal sample or pathological sample).

The data can be saved to a CD / DVD ROM, an external disk,


a network drive if the PC is networked or any adapted
medium. This option allows also the operator to restore data
from the same device, back to the complete database of the
software.

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After having confirmed this option, all active windows will be
closed.
CAUTION: Stored data may be lost if this application is
not properly used. This option is only available after a
working session, when the instrument status is
"OFFLINE".
If not, the following window is displayed:

Backup samples / Restore samples operations:

Description of the buttons and sections of the dialogue


box:

BUTTONS FUNCTION

and Expands or closes the tree structure

Opens the tree structure by program


and year and vice/versa
Refreshes the data when new
information has been entered into
the worklist
Displays the worklist for the selected
samples.
NOTE: To select a sample, click on
the record to view.
To anonymize the selected samples
before backup them
To add associated calibrators
(patterns and calibration information)

From the "Backup samples" folder, click on the button of


the corresponding dialogue window to indicate the access
path to the database file where to backup the samples.

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From the "Restore samples" folder, click on the button of


the corresponding dialogue window to indicate the access
path to the database file containing the data to be restored.
The "Cards" section shows the number of detailed cards
contained in the selected records.
The "Mbyte" section shows the size of the selected files.

Backup samples:
After a click on the "Backup samples" tab, the following
dialogue box will open:

The program tree is shown automatically.


Select the analysis program to be backed up by placing a
check mark next to the box (e.g., PROTEIN(E) 6). If a check
mark is placed next to a program box, then all the samples
from that program will be saved.
If a specific date is needed, expand the tree by selecting the
"+", which automatically makes the box a "-". This will expand
the data by: year, month and day.
Place a check mark on the data that need to be saved.
To save only normal and / or pathological samples, click on
the check boxes in the "Normal samples" and / or
"Pathological samples" section.
To start the save operation, click on "Copy" or "Move".

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Select "Copy" and a prompt will appear asking to copy the
files from the Total.mdb to the predetermined folder. Select
"Yes" and the files will be copied.

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).

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Use the same method as described in the "Backup samples"
section to select analyses or to expand the tree.
To restore only normal and / or pathological samples, click on
the check boxes in the "Normal samples" and / or
"Pathological samples" section.
To start the restore operation, click on the "Copy" or "Move"
buttons.

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.

NOTE: If a link has been created between an IT curve and a


protein curve, saving or restoring one will also save / restore
the other.

4.3.5.6. UPDATE DATABASE

Use this command to update the database.

4.3.5.7. IF/BJ, CSF, URINE IMAGE COMPRESSION

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.

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4.3.6. "HOST" MENU

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.

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4.3.7. "SCANNER" MENU

Use this menu to scan HYDRAGEL gels from a flatbed scanner (please contact
SEBIA for information about the recommended device).

This menu has commands for the following operations:


- opening the scanner window,
- displaying the images of the gels scanned within the last 2 scanning operations,
- reading mode,
- positive identification Assist/Hydraplus.
CAUTION: The "Start scanning" command is not available in Recall Mode.

4.3.7.1. START SCANNING

Use this command to open the "Gels and samples scanning" window.

This command can also be run by clicking on the icon.

PREPARING THE GEL FOR SCANNING

Before scanning gels:

- remove the gel alignment frame,

- 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.

- Be careful not to scratch or damage the glass surface.

- Do not use a hard or abrasive brush to clean it. A damaged


glass surface can decrease the good functioning of the
scanner and the scan quality.

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- Never use alcohol, thinner, or corrosive solvent to clean the


scanner. These chemicals can damage the scanner
components and the case.

- 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.

BUILD THE WORKLIST

Before scanning the gels, it is recommended to either manually build the


worklist, or download the worklist from the HOST computer (please refer
to § 4.3.2. "WORKLIST" MENU for more details).

PLACE THE GELS ON THE SCANNER

- 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.

- Close the scanner lid.

SELECT THE SCANNER ICON

After the gels are placed on the scanner, select the scanning icon.

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The following screen is displayed:

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.

Selection of the program


Select the program of the first scanned gel in the position GEL (1). If a
second gel is scanned, its program can be selected in the position
GEL (2). Six gels can be simultaneously programmed.
To change the analysis program attributed to each gel, click on the
program name next to the gel number and then select the required
program from the dialogue box.

Selection of the gel type


To select the gel type, click inside the gel frame until the right gel type is
displayed (gel 7, 15, 30, etc.) (a picture of the gel corresponding to its type
is displayed on the screen to facilitate the selection of the gel type).
CAUTION: The order in which the gel samples are numbered will
change if the gel type or gel sample numbers of the 1st gel is altered.
In this case, the numbers shown in the "Gel sample number" section
can be calculated again by clicking on "Reset Sample No.".
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Selection of samples for scanning
The whole surface of the selected gel is scanned by default.
If the gel contains a number of analyzed samples lower than the real
number of samples that could be analyzed on this gel, or if only a part of
the gel is to be scanned, right click in the gel image frame and move the
cursor over the sample numbers that are not to be scanned.

- numbers shown with a green background refer to samples that will be


scanned,

- numbers shown with a white background refer to samples that will not
be scanned.

Description of the buttons in the "Sample selection" window:


The buttons in the "Sample selection" window are as follows:

- All : to select all the samples analyzed on the gel,

- None : to deselect all samples analyzed on the gel.

Changing of the sample numbers on gels


Gels obtained with the same technique and scanned during one scanning
sequence are numbered from 1 onwards.
CAUTION: If a second scanning sequence is carried out for the same
analysis technique, the information for samples that were assigned
numbers during the 1st scan sequence will be overwritten.

- 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.

- Enter the new number in the "Change sample number" section.

- Before starting to scan, check the information in the "Gel type",


"Sample selection" and "Gel sample number" sections. If the gel
sample numbers do not match the numbers in the worklist, click on
"Reset Sample No." to re-increment the numbers.

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- 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.

Gel treatment options


Perform gel analysis: the electrophoretic pattern is saved.
Perform gel analysis and save the scanned image: the electrophoretic
pattern and the complete picture of the gel are saved.
Scan the gel and save the image: only the complete picture of the gel is
saved.
The pictures are saved with the date and the time of the scanning.

IMAGE ACQUISITION

Click on "Start Scanning" to import the images.

VIEWING SCANNED IMAGES

Click on "View scanning" in the "Scanner reading" window. This will bring
up the following dialogue box:

Navigation pane
Scan position line

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Pan Window
The "Pan Window" contains the navigation pane (inverse video) defining
the area of the gel that is displayed in the "View scanned gels" window.
To move the navigation pane, click on the required spot inside the "Pan
Window" or keep the mouse button pressed in and drag to the required
spot.

"Scanning Identifications" window


This window shows the track numbers of the gel being viewed in the "Pan
Window".
Track numbers shown with a magenta background indicate curves where
the fraction identification program could not identify.
To show the curve in the "View scanned gels" window, click on the
corresponding curve number to view it.
To open the curve review window, double click on the curve number.

"View scanned gels" window


The "View scanned gels" window shows:

- a magnified view of the image defined in the navigation pane,

- the curve and the patient data,

- image adjustment buttons,

- the number of the gel currently being viewed,

- 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.

Curves and patient data


The curve and the patient data displayed on the right side of this window
originate from the track in the magnified image on which the cursor has
been placed.

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Description of display buttons in the window:

BUTTONS FUNCTION

GEL Brings up an image of the next / previous gel

Zooms in and out on the part of gel image in the


Zoom +/-
window

1:1 Restores the image to its original size

Changes the contrast of the gel image (Video


Cursor
Correction setting)

Reset Reverts to the original contrast

Reverse Displays the gel image in inverse video format

Pan Window Opens the Pan Window

Close Closes the window

Number of the gel currently being viewed

Move through the list of gels one at a time by clicking on the


buttons.
NOTE: Only two gels can be stored in memory.

MANAGING IMMUNOFIXATION IMAGES

The software can match immunofixation images (HYDRAGEL IF,


HYDRAGEL BENCE JONES, HYDRAGEL CSF ISOFOCUSING,
HYDRAGEL URINE PROFIL(E), HYDRAGEL CSF and
HYDRAGEL 2 IF / BJ (HR)) images to scanned PROTEIN(E) gels.

Immunofixation pattern acquisition


The patient data must be previously entered in the PROTEIN(E) analysis
program.
Immunofixation pattern scanning and link to a PROTEIN(E) analysis can
be done using 2 different ways:
1/ Select a PROTEIN(E) analysis program in the status bar (see § 4.3.3.4.
CHANGE WORKING PROGRAM) and set the corresponding program in
the window containing the immunofixation gel (see § SCANNER
SETTINGS).
Run the image scanning sequence by clicking on the "Start scanning"
button.

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MATCHING AN IF IMAGE TO A PROTEIN(E) CURVE

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).

2/ The second way consists in selecting the corresponding immunofixation


scanning program in the status bar and scanning the HYDRAGEL gel. To
associate it to a PROTEIN(E) curve, click on "Auto. Link" button on the
worklist by table. The following window will then be displayed:

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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.

Displaying the immunofixation pattern


To view an immunofixation pattern and add a comment if required, select
the image of the immunofixation corresponding to the PROTEIN(E)
analysis program from the status bar.
To bring up the immunofixation pattern, click on "View" in the "Attached
card" section of the PROTEIN(E) curve review window.
Enter a comment and / or the protein values in the relevant fields in the
"Attached card" window.

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To magnify the immunofixation pattern on the right-hand side, double click
on the image.

The mouse cursor is tracked by a horizontal green line so that the


alignment of the track bands can be checked.

Description of the buttons in the dialogue box:

BUTTONS FUNCTION

Zooms in and out on the part of gel image in the


Zoom +/-
window

1:1 Restores the image to its original size

Cursor Changes the contrast of the gel image (Video


button Correction setting)

Reset Reverts to the original contrast

Reverse Displays the gel image in inverse video format

Print Prints the immunofixation image

Close Closes the window

NOTE: It is possible to quantify the reference protein track ("fixative


solution" track) on HYDRAGEL IF Penta 6/12 gels, obtained with the
Dynamic mask or Standard mask techniques. To run an image acquisition
sequence, click in the status bar to select the HYDRAGEL PROTEIN(E)
program and follow the instructions in § PREPARING THE GEL FOR
SCANNING and VIEWING SCANNED IMAGES.

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4.3.7.2. VIEW THE LATEST SCANNED SAMPLES

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.

4.3.7.3. READING MODE

This function allows (if the standardized mode is selected) to apply a


calibration factor to the results generated by densitometry analysis, in
order to get closer to the values generated by capillary electrophoresis or
by nephelometry.

4.3.7.4. POSITIVE IDENTIFICATION ASSIST/HYDRAPLUS

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).

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4.3.8. "UTILITIES" MENU

Use this menu to:


- automatically calculate statistics for quality control with each analysis program,
- change the settings for the presentation of analysis results,
- apply a correction factor to the results,
- shut down the PC automatically,
- restrict operator authorization.

4.3.8.1. QUALITY CONTROL

Use this command to calculate statistics, enter control values and display
LEVEY JENNINGS charts.

4.3.8.1.1. STATISTICS

Statistics are calculated for all identified samples in the same


analysis program and instrument over a specified period.

The statistics dialogue box contains four sections:

INSTRUMENT

Click on the drop-down menu ( ) to select the instrument


by its name and serial number.

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WORKING PROGRAM

Click on the drop-down menu ( ) to select an analysis


program.

RANGE OF TIME

Check one of the three option boxes. Enter the dates where
required.

SEARCH SAMPLE BY…

Specify the number of fractions to be used in the calculation


and the name of the sample to be analyzed.
NOTE: Default values are automatically entered in the
"Fraction number" and "Sample name" fields. To calculate the
statistics using all samples over a given period, type an
asterisk (*) in the "Sample name" field.
After clicking on "OK", a statistical table will be shown for the
selected program.

This table indicates for each fraction the values in percentages


(minimum values (MIN), median values (MED) and maximum
values (MAX)), the standard deviation (SD) and the coefficient
of variation (CV %).

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Particular case :
With the HbA1c procedure, this table indicates for each result
of HbA1c fraction [concentration in mmol/mol and calibrated
percentage (cal %)] the minimal values (MIN), median values
(MED) and maximum values (MAX), the standard deviation
(SD) and the coefficient of variation.

Click on the "Print" button to print the table.

4.3.8.1.2. SETUP CONTROL VALUES

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.

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To enter the control values, click on the "setup…" button. The
following dialogue box will appear:

Enter the values provided in the instructions for use included


with the control sample kit and refer to § 4.3.3.2. QC MODE.
CAUTION: Use the decimal separator according to the
current operating system (dot or comma).

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.

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4.3.8.1.3. LEVEY JENNINGS CHART

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).

Select the type of control from the drop-down ( ) menu


(Low, Medium or High) and then click on "START" to confirm.
The window will show the values for the fraction that is
highlighted in green.
The values of another protein fraction can be viewed by
clicking on its name above the graph.
Clicking on one of the blue dots in the graph will show the
curve number, the graph line and the saved date.

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It is possible to delete a dot by clicking on the "Delete dot"
button.
All the dots must be included within the standard deviation
range.
NOTE: With the HbA1c procedure, the Levey Jennings chart
presents 2 units for the HbA1c fraction (mmol/mol and cal %).
Click on the name above the chart to view the corresponding
curve.

Description of LEVEY JENNINGS chart tool bar:

BUTTONS FUNCTION
Opens a dialogue box from which
to select a saved file

Saves the chart

Prints the chart

Heading and Click to add the laboratory header


comment and comments
Shows statistics (see § 4.3.8.1.1.
Statistics…
STATISTICS)
Number of samples listed as QC

Zooms in or out on the Y-axis

Close Closes the window

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4.3.8.2. CUSTOMER CONFIGURATION

Use this command to:

- change the settings for each analysis program,

- add, delete or change comments,

- change normal ranges (in percentages and in concentration),

- set up the ratios between fractions,

- set up the fractions identification table,

- customize the name of free fields,

- set up display parameters of curves and,

- create links between a code and the name of a department or


laboratory.

4.3.8.2.1. ANALYSIS PROGRAMS

Use this option to change the settings of each analysis


program and / or to create a new analysis program.
Each analysis program is defined on the following parameters:

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)

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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".

4.3.8.2.2. COMMENT LISTS

Use this option to enter comments. These will then be shown


in the review window (see § 4.3.3.2. ZONE E: COMMENTS).
NOTE: The comments are specific for the selected analysis
program.

Select an analysis program from the drop-down list ( ).


To delete a comment, click on the column to the left of the
comment and then click on the "Delete" button.
To modify a comment, click on the column to the left of the
comment and then on the "Modify" button.
This will open a new window to enter the new comment. Then,
click on "OK".
To add a new comment, click on the "New" button.
This will open a new window to enter the new comment. Then,
click on "Add".

4.3.8.2.3. NORMAL RANGE IN %

Select this option to display the minimum and maximum


percentages of each fraction; they will appear on the printed
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result report and will be used as a reference for determining
the alerts that are shown automatically in the "Fraction values"
section of the review window (see § 4.3.3.2. ZONE B:
FRACTION VALUES).
NOTE: Each analysis program has its own normal values.

Select an analysis program from the drop-down menu ( ).


To insert or change the normal value, click on the appropriate
cell and edit the current value or enter a new value.

CAUTION: This table does not indicate the names of the


fractions. To assign the normal values to the correct
fraction, see § 4.3.8.2.6. FRACTION NAME
IDENTIFICATION TABLE.
The "Manage categories" option allows to create several
tables of normal ranges per analysis program.

4.3.8.2.4. NORMAL RANGE IN CONC.

Select this option to display the minimum and maximum


concentration limits for each fraction; they will appear on the
printed result report.
The available options are the same as for the % limit values
(see § 4.3.8.2.3. NORMAL RANGE IN %).
The "Manage categories" option allows to create several
tables of normal ranges per analysis program.

4.3.8.2.5. RATIO SETTINGS OPTION

This option allows to define the ratios between fractions to


calculate, and to see the results in the edit curve dialogue
window.

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It is also possible to set the number of ratios (0, 1 or 2), the
name of the ratios, the normal values, and to consider the
ratio as pathological if it is higher than the normal one.

With the NEONAT Hb analysis program, the "Ratios Settings"


window allows to enter the "Low threshold" and "High
threshold" values for A/F and A/X ratios with X = S, C, E or
other Hb. The ratios calculation is based on peaks
identification, such as Hb A and Hb F and on the presumptive
identification of other peaks: Hb S, Hb C, Hb E….

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.

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- Enter both low threshold and high threshold values
together, under a format that can be recognized by the
software (otherwise, a warning signal alerts the operator).

4.3.8.2.6. FRACTION NAME IDENTIFICATION TABLE

Selecting this option displays the names of the fractions for


each analysis program.

Select the required analysis program from the drop-down list

( ).
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.

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The "Manage categories" option allows to create several
tables of normal ranges per analysis program.

4.3.8.2.7. CUSTOMIZE FREE FIELDS

Selecting this option displays the names of free fields that can
be used in the worklist.

Click on the appropriate field to enter or edit a field name.

4.3.8.2.8. DISPLAY PARAMETERS

GENERAL PARAMETERS

This option allows the operator to set the curves validation


options, to set the relative curve area regarding to the size of
the window (according to the "aspect ratio" parameter), to set
the order in which curves are displayed, to set the displayed
zones and peaks and to set the colors in which pathological,
normal, abnormal, pathological or with increased HbA1c value
curves are displayed.

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CURVE DISPLAY PARAMETERS

This option allows to set the curve display parameters.


Select the analysis program from the "Program" drop-down

menu ( ).

4.3.8.2.9. DEPARTMENT LIST

Selecting this option displays a list cross-referencing


alphanumerical codes and departments. The name of the
department will be automatically displayed when its
alphanumerical code is entered in the worklist.

Enter the alphanumerical code and the department name in


the allocated fields.

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To create the match, click on the "Activate department code"
button in the worklist by single sheet dialogue box (see §
4.3.2.1. ENABLE DEPARTMENT CODING). To delete a
match, click on the field of the match that is to be deleted and
then on "Delete".

4.3.8.2.10. LAB./PATHOLOGIST LIST

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.

Enter the numerical code, the name of the laboratory, the


modem number and the e-mail address in the allocated fields.
To delete a match, click on the field of the match that is to be
deleted and then on "Delete".

4.3.8.3. CALIBRATION FACTOR

Use this command to apply a correction factor to the analysis results.

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Selecting the analysis program

Select the analysis program from the "Program" drop-down menu ( ).

Selecting the fraction

Select the fraction from the "Fraction to correct" drop-down menu ( ).


NOTE: The list of fractions in the "Fraction to correct" menu is the same
as the list in the fraction identification table that was created for the
analysis program.

Adding a correction factor (A and / or B)


Slide the cursor button(s) or enter the correction factors directly in the
"Current factor" text boxes (in this case, add the - sign for negative
values).
Click on "Apply new factor" to confirm the correction factors that were
entered.

4.3.8.4. AUTO POWER-OFF

Select this command to activate / deactivate the automatic shutdown


sequence for the Windows® operating system.

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The automatic shutdown is deactivated by default.


To use the automatic shutdown, click on the check box and enter the time
at which the operating system is to be shut down automatically.
CAUTION:
- All open files will be closed when the Windows® operating
system is shut down.
- The automatic power off does not launch the shutdown procedure
of the automated instrument.

4.3.8.5. OPERATOR LIST

This command allows to display the list of users and shows their level of
authorization (level of authorization range between 1 and 4).

Two modes are available:

- Supervisor mode, with unlimited access.

- User mode, with access restricted to the authorized level.

LEVEL ACCESSIBILITY

Level 1: Same as for the supervisor.

Unauthorized commands: menu for updating the

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instrument parameters and menu for operators’
configuration.

Level 2: Limitations of level 1.

Scan, edit and search curves.


Unauthorized commands: program configuration,
customize report, backup and restore, quality control
(statistics, setup control values and Levey Jennings
chart), customer configuration, calibration factor and auto
power-off.

Level 3: Limitations of level 2.

Scan and edit curves.

Unauthorized commands: search by criteria, change


working date and anteriority visualization window.

Level 4: Limitations of level 3.

Scan curves.

Unauthorized commands: view fraction values, change


working program, all search functions and scanner
functions.

NOTE: The identification procedure can be switched off by checking the


box marked "Disable password request when PHORESIS starts
(Administrator mode)".

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4.3.9. "WINDOW" MENU

The "Window" menu shows all the windows that are currently open. Select a window
from the list to make it the active window.

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4.3.10. "HELP" MENU

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.

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4.3.11. RESULTS TRANSMISSION / RECEPTION VIA E-MAIL

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:

4.3.11.1. RESULT SEND

The result transmission could be done by using 2 different modes:


automatic transmission or manual selection. If the operator asks for the
automatic transmission mode, the results to transmit have to be pre-
selected as follows:

- select WORKLIST / WORKLIST BY SINGLE SHEET,

- click on the "Options" button,

- select "Free field 3",

- click on the "OK" button,

- select WORKLIST / WORKLIST BY TABLE,

- 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.

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Transfer results as follows:

- click on the "Result send" option button,

- click on the "Next" command button,

- select the operating mode (automatic transmission or manual


selection),

- select the data format (Backup file or PDF file),

- click on the "Next" command button,

- select the analysis program(s) to send from the program drop-down

menu ( ) for the automatic mode or enter the reference numbers of


the samples to be sent for the manual mode,

- if necessary, mark the "Anonymize selected samples" (a message will


be displayed to alert the operator when he is about to send by mail non
anonymized samples),

- click on the "Next" command button.

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A window will open showing the number of samples that have been
selected.
Click on "Next" and select the receiving laboratory from the drop-down

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.

4.3.11.2. RESULT IMPORT

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:

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Then, select one of the following three results storage modes:
Automatic: The imported samples are stored using the sample reference
number assigned by the transmitting system.
CAUTION: Make sure that the reference numbers of the samples that
are imported are not already used in the database (otherwise the
data will be lost).
Queuing: The reference numbers assigned to the imported samples follow
on from the last reference numbers in the target database.
Manual: The imported samples are stored beginning with the required
number.
Click on "Next": the software is now ready to receive the results. Click on
"Next" again.

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4.3.12. NETWORK CONNECTION

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.

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4.4. STATUS BAR

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.

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5. USING THE SOFTWARE

5.1. PREPARATION OF THE SCANNING

1. Switch on the scanner and the host computer.


2. Click on the "PHORESIS" icon to start the software; enter the operator identification and
select an analysis method.
3. Create the worklist (see § 4.3.2.1. WORKLIST BY SINGLE SHEET or § 4.3.2.2.
WORKLIST BY TABLE).
4. Refer to § 4.3.7.1. START SCANNING to perform the scanning.

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.

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5.2. RESULTS OF ANALYSIS

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).

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5.3. QUALITY CONTROL

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

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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.

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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.

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7. PERFORMANCE LEVELS
See the SEBIA kits instructions for use.

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8. INTERFERENCES AND LIMITS OF USE


See the SEBIA kits instructions for use.

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9. BIBLIOGRAPHY
See the SEBIA kits instructions for use.

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10. REGULATORY INFORMATION


SEBIA satisfies the following requirements:
● With regard to European Directives the following applies:
- 98/79/EC on in vitro diagnostic medical devices (IVDMD).

● With regard to quality management standards the following applies:


- EN ISO 9001 : "Quality Management Systems - Requirements",
- EN ISO 13485 : "Medical Devices - Quality management systems - Requirements for regulatory
purposes".

● 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".

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11. INDEX

A  F 

ADVANCED BACKUP .................................... 90 FILE ................................................................ 17


ANALYSIS PROGRAMS .............................. 113 FOREWORD .................................................... 5
AUTO POWER-OFF ..................................... 121 FRACTION NAME IDENTIFICATION
TABLE ....................................................... 117


BACKUP ......................................................... 89
BACKUP CONFIGURATION .......................... 89 HELP ............................................................ 125
BIBLIOGRAPHY ........................................... 139 HOST ............................................................. 95

C  I 

CALIBRATION FACTOR .............................. 120 IF/BJ, CSF, URINE IMAGE


CHANGE PRINTED REPORT ORDER ......... 76 COMPRESSION ......................................... 94
CHANGE WORKING DATE ........................... 85 INSTALLATION ................................................ 8
CHANGE WORKING PROGRAM .................. 75 INTERFERENCES AND LIMITS OF USE ... 138
COMMENT LISTS ........................................ 114

CURVES PREVIEW (MOSAIC) ..................... 36
CUSTOMER CONFIGURATION .................. 113 LAB./PATHOLOGIST LIST .......................... 120
CUSTOMIZE FREE FIELDS ........................ 118 LAYOUT OF THE SOFTWARE ..................... 13
CUSTOMIZE REPORT .................................. 20 LEVEY JENNINGS CHART ......................... 111

D  M 

DATABASE .................................................... 85 MAINTENANCE ........................................... 136


DELETE SAMPLES ........................................ 88 MOVE SAMPLES ........................................... 88
DELETE THE LABELS "KNOWN

PATHOLOGICAL PATIENT" ....................... 83
DEPARTMENT LIST .................................... 119 NETWORK CONNECTION .......................... 130
DESCRIPTION OF THE COMMANDS........... 14 NORMAL RANGE IN % ............................... 114
DESCRIPTION OF THE MAIN MENU ........... 16 NORMAL RANGE IN CONC. ....................... 115
DISPLAY PARAMETERS ............................. 118

E  OPERATOR LIST......................................... 122
EDIT CURVE .................................................. 36

EDIT CURVES ............................................... 39
EXIT ................................................................ 24 PERFORMANCE LEVELS ........................... 137
POSITIVE IDENTIFICATION
ASSIST/HYDRAPLUS .............................. 106
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PREPARATION OF THE SCANNING .......... 132 SETUP CONTROL VALUES ........................ 109
PRINCIPLE ....................................................... 7 START SCANNING........................................ 96
PRINT REPORTS .......................................... 75 STATISTICS................................................. 107
PRINT WORKLIST ......................................... 35 STATUS BAR ............................................... 131
PRINTER SETUP ........................................... 20 SUMMARY REPORT ..................................... 76
PROGRAM CONFIGURATION ...................... 17


TECHNICAL SPECIFICATIONS ...................... 8
QUALITY CONTROL ............................ 107, 134 TECHNICAL SPECIFICATIONS AND
ENVIRONMENTAL CONDITIONS................ 8


RATIO SETTINGS OPTION ......................... 115
READING MODE ......................................... 106 UNPACKING AND CHECKING THE
RECOMMENDED PC SYSTEM CONTENTS ................................................ 11
REQUIREMENTS ......................................... 9 UPDATE DATABASE..................................... 94
REGULATORY INFORMATION ................... 140 UPDATE PATIENT HISTORY
RESULT IMPORT ........................................ 128 INFORMATION ........................................... 84
RESULT LIST ................................................. 72 USING THE SOFTWARE ............................ 132
RESULT SEND ............................................ 126 UTILITIES..................................................... 107
RESULTS OF ANALYSIS ............................ 133


VIEW DATABASE HISTORY ......................... 85
SCANNER ...................................................... 96 VIEW THE LASTEST SCANNED
SEARCH ......................................................... 77 SAMPLES ................................................. 106
SEARCH FOR ABNORMAL CURVES ........... 80

SEARCH FOR KNOWN
PATHOLOGICAL PATIENTS ...................... 80 WINDOW...................................................... 124
SEARCH FOR PATIENT HISTORY ............... 77 WORKLIST..................................................... 25
SEARCH FOR PENDING SAMPLES ............. 83 WORKLIST BY SINGLE SHEET .................... 25
SETTING UP THE SOFTWARE .................... 12 WORKLIST BY TABLE .................................. 29

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