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PHOENIX

User’s Manual

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Contents

CONTENTS ............................................................................................................................. III

1 INSTALLATION AND START-UP..................................................................................... 7

1.1 First installation .......................................................................................................................... 7

1.2 Upgrade ...................................................................................................................................... 10

1.3 Phoenix Program Start-up ....................................................................................................... 11

1.4 File Menu ................................................................................................................................... 13

2 PATIENTS DATABASE .................................................................................................. 15

2.1 Patients List ............................................................................................................................... 16

2.2 Patient Data ............................................................................................................................... 17

2.3 Editing Patient Data.................................................................................................................. 17

2.4 Selecting a Patient ..................................................................................................................... 17

2.5 Advanced Search ....................................................................................................................... 18

2.6 Delete Patient ............................................................................................................................. 20

3 EXAMINATIONS DATABASE ........................................................................................ 21

3.1 New Exam .................................................................................................................................. 21

3.2 Selecting an Examination ......................................................................................................... 21

3.3 Editing Examination Data ........................................................................................................ 22

3.4 Deleting an Examination .......................................................................................................... 22

3.5 Refraction .................................................................................................................................. 22

3.6 Capture ...................................................................................................................................... 23

3.7 Image Gallery ............................................................................................................................ 23

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4 SETTINGS ....................................................................................................................... 26

4.1 Language .................................................................................................................................... 26

4.2 Groups ........................................................................................................................................ 26

4.3 Miscellaneous (Other) ............................................................................................................... 27

4.4 DICOM (Digital Imaging and Communication in Medicine) ............................................... 28

4.5 Instruments ................................................................................................................................ 31

4.6 Activations ................................................................................................................................. 33

5 CAPTURE ....................................................................................................................... 34

5.1 Capture settings......................................................................................................................... 35

5.2 Photo Capture ........................................................................................................................... 36

6 IMAGE GALLERY MANAGEMENT ................................................................................ 38

6.1 Toolbar Buttons Summary ....................................................................................................... 39

6.2 Editing selecting cells ................................................................................................................ 39

6.3 Deleting cells .............................................................................................................................. 41

6.4 Editing image parameters ........................................................................................................ 42

6.5 Analysis ...................................................................................................................................... 44

6.6 Analysis results .......................................................................................................................... 47

6.7 Comparison................................................................................................................................ 49

7 PRINTING ....................................................................................................................... 51

APPENDIX A. INTRODUCTION .......................................................................................... 54

1. INTRODUCTION ......................................................................................................................... 54

2. BRIEF DESCRIPTION OF THE INSTRUMENT – USES ..................................................... 54

APPENDIX B. IMPORT – EXPORT EXAMS ....................................................................... 56

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1. Exporting an examination ............................................................................................................ 56

2. Importing an examination ............................................................................................................ 56

APPENDIX C. SAFETY ....................................................................................................... 57

APPENDIX D. GENERAL SAFETY PRECAUTIONS .......................................................... 58

1. General precautions ...................................................................................................................... 58

2. Using precautions .......................................................................................................................... 59

APPENDIX E. INSTALLATION OF THE INSTRUMENT ..................................................... 61

APPENDIX F. INSTALLING CAPTURE .............................................................................. 64

APPENDIX G. TECHNICAL DESCRIPTION ....................................................................... 65

1. Technical features ......................................................................................................................... 65

2. Classification according to regulatory EN60601- 1/08/90 ........................................................ 65

3. Reference standards: .................................................................................................................... 65

APPENDIX E. IMPORT-EXPORT EXAMS .......................................................................... 67

1. Exporting an examination ............................................................................................................ 67

2. Importing an examination ............................................................................................................ 67

APPENDIX F. SAFETY ........................................................................................................ 69

APPENDIX G. CONFIGURE PVIEWER (IPAD)................................................................... 70

How to configure Phoenix .................................................................................................................... 70

How to configure your iPad ................................................................................................................. 72

Create an ad hoc wireless connection .................................................................................................. 75


Ad hoc connections on windows XP .................................................................................................. 78

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1 Installation and Start-up


1.1 First installation
Pass to chapter 1.3 if the Phoenix software has just been installed.

Insert the CD and wait for the installation procedure to start:


If Framework 4.0 is not installed on the PC, the next screen will be displayed.
Accept the licensing conditions and click Accept.

Figure 1-1: Accept installation of framework

Wait until the component is installed.

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Figure 1-2: Framework install

Upon completion of the procedure outlined below or if Framework is already installed, click Next to
begin installing Phoenix.

Figure 1-3: Phoenix install

Select the file path for software installation and click Next.
We recommend not changing the default file path displayed.

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Figura 1-5 Confirmation install


Figura 1-4 Installation directory
Click Next to complete installation; Click Close at the end of installation.

The following screen appears. Click OK to confirm and proceed installation of a demo database,
Cancel in case of an upgrade.

Figura 1-6 - Install DB

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The “Phoenix” icon will appear on the desktop.

1.2 Upgrade
In case of an upgrade of the Phoenix software (i.e. an installation of the Phoenix software on a system
where an older version already was installed), the following message might appear upon uninstalling
the old version:

Figura 1-7 - Service active

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This means the WCF service menu has been used to install the Web Service interface for Phoenix.
Please make sure to uninstall the service, following Start Menu -> All Programs -> CSO -> Phoenix ->
WCF Service-> Uninstall PSvcHost

After this, the uninstall will correctly complete. See the appendix for more information on the
installation of the WCF Sercvice.

1.3 Phoenix Program Start-up


Click the Phoenix icon on the desktop. The screen shown below will appear, asking the user to send an
e-mail containing the code for unlocking the software.

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Figure 1-8: Registration Screen

You need to connect the database when you open the first time the software. Press OK if the database
has been created during the installation and Phoenix is ready to use.

If the database is just present, press browse button and select phoenix.mdb. You need to connect the
root.cso file contents in the same database folder. Open the Miscellaneous menu in the settings and
check if the Image root field is complete. Otherwise search the root.cso that will be in the database
phoenix.mdb folder (see 4.3).

Figure 1-9: Database connection

Confirm pressing OK. The main screen will open.

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Figure 1-10: Main Screen of the Phoenix Program

This first screen allows the user to manage the database of patients and the examinations associated
with each. It is made up of various sections and menus.
When the program is launched, all the windows are empty.

1.4 File Menu

Settings
Allows the user to select the software language, manage groups and instruments, and make
other settings (see Chapter 4). This menu may be accessed only if the patient list is not

displayed. If patients are displayed in the list, click [Clear Patient List] to enable the
Settings function.

Esc
Exits and closes the program.

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Figure 1-11: Confirm Exit from Program

Selecting the suitable box on the Settings/Other menu (see Chapter 4), displays a request for
confirmation of exit from program. Click Yes to exit or No to continue using the program.

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2 Patients Database

Figure 2-1: Search Panel

Each patient is identified by Last Name, First Name, and an Identification Code that is automatically
generated by the program.
To locate a patient in the Database, type the Last Name and First Name in the Patient Box or type the
Identification Code.
To select a search criterion, click the button alongside Last Name, First Name or alongside the
Identification Code.
To view a patient, type his/her Last Name, First Name (or Identification Code) in the Patient Box. As
the letters or numbers are typed, the pull-down list will display patients meeting the criteria. If the
typed characters do not yield any results, a warning icon will appear . The warning icon is also
displayed in the case an excessive number of results is returned.
Once a patient is selected, his/her Last Name, First Name (with Identification Code and date of birth)
will be displayed in large type in the top portion of the screen.

Fill Patient List


Displays all the patients entered in the database.

Empty Patient List


Empties the contents of the window in which the patient list is displayed but does not delete the
patients from the database.

Search
Permits searching patients in the database by gender, date of birth, check-in number,
examination date, patient age, referring physician, instrument, or group (see Paragraph 2.5).
To enter a new patient in the database, click the icon on the main screen to open a new window
Enter the patient data in the window: last name, first name, date of birth, and gender. Typing a Last
Name, First Name pair in the Patient Box automatically opens the window for entering the data for the
new patient.

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Figure 2-2: New Patient Data Window

Date of birth must be entered in the form: two digits for the day, two digits for the month, and four
digits for the year. Entering an invalid datum will cause a warning icon to be displayed.
Entering a patient whose data are identical to those of a patient already contained in the database will
likewise open a window containing a warning message.
The identification code is automatically entered by the system unless a different option is selected from
the DICOM Settings menu. See Chapter 4.3.
To confirm new patient entry, press the Enter key or click the [OK] button. To cancel, click [Cancel].
Whenever a new patient is created, an examination associated with that patient is also created. A
window for selecting the examination type then opens (See New Exam below).

2.1 Patients List


Any new patient entered is displayed in the patients list window on the left-hand side of the screen. To
view the list of all the patients entered, click the button. To empty the contents of the patients list

from the main screen, click the button.

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2.2 Patient Data


When a patient is selected, the entered data will be displayed on the main screen (red rectangle).

Figure 2-3: Patient Data

2.3 Editing Patient Data


To edit the patient data, move the mouse pointer to the patient name and right-click. Select
, which reopens the patient data window for editing the last name, first name,
date of birth, and/or gender. Click OK after having made all required changes.

2.4 Selecting a Patient


A patient already listed in the database can be selected in a number of different ways:
 Type a last name and first name in the Patient Box. In order to insert the last name and name
correctly you must type: Last Name comma First Name, without spaces. If the typed name does not

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correspond to any patient already present in the database, press Enter to open the window for
entering a new patient.
 Click the button and use the ↑ ↓ keyboard keys to scroll the patients list or select a patient
directly from the list. With the Patient Box empty, press Enter or double-click the highlighted
patient name. A patient archive may be opened by clicking the button to the left of the name.
 Type in a portion of the Last Name, First Name string to display a list of patient names meeting the
criteria. To select a particular patient, proceed as described in the previous point. For instance, you
may display all the patients whose names begin with a given letter, or who have the same last name,
or who have the same last name and the same first-name initial, etc.

When a patient is selected, the list of associated examinations opens automatically (see Chapter 3:
Examinations Database).

2.5 Advanced Search

Click the button to access the advanced search function.

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Figure 2-4: Advanced Search

For each of these categories, clicking the button so as to check (select) it visualizes the
boxes for entering search criteria:
 by gender: male or female
 by date of birth: start and end dates of the interval to be searched
 by check-in number: a box for entering the number; this field features the automatic
completion function
 by examination date: start and end dates of the interval to be searched
 by patient age: minimum and maximum age
 by referring physician: a box in which to type the physician’s name
 by instrument: a list of possible examination capture instruments (for example, Fundus
camera, keratoscope, pupillographer, Scheimpflug camera, slit lamp biomicroscope)
 by group: a list of the groups created via the Settings function (see Chapter 19)
 by caption: the caption added to a single acquisition is used as a search parameter

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Select the boxes that permit establishing the search criteria. Click [Search] to display the search results.

2.6 Delete Patient

To delete a patient name, right-click the patient, select and then confirm the
deletion request warning message.
Warning: deleting a patient also deletes all the examinations associated with that patient and the
relative images.

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3 Examinations Database
An unlimited number of examinations may be associated with each patient; the examinations are
defined on the basis of the instrument used and the date of creation.

3.1 New Exam

After a new patient is created, an examination will also be created.

To create a new examination for an existing patient, click the button.


If working with a single instrument, the image capture mode will be automatically accessed. Otherwise,
if at least two instruments are used, the window shown below will open. Select the instrument to be
associated with the current examination. After selection, the capture mode is accessed.

Figure 3-1: Instrument Selection

Each examination is filed by date of creation and instrument type. It is also possible to attribute a
pathology group [Group ]. Classifying the examinations by codified groups is useful for conducting
searches. The groups list may be edited from the Settings menu (see Paragraph 4.2).

3.2 Selecting an Examination


Once a patient has been selected, click the button or press Enter or double-click with the mouse to
access the Examinations Database.
Clicking the + symbol to the left of the patient name opens the list of examinations associated with that
patient. The + symbol becomes a – . Click the – symbol to close the list.
Alternatively, open the list by pressing the  arrow key on the keyboard and close it by pressing the
 arrow key.
To select a previously-stored examination, use the mouse or scroll with the ↓↑ keyboard arrows to
highlight one examination after another and, for each, view the relative images in the window on the
right-hand side of the screen.

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3.3 Editing Examination Data


To edit the data for an examination, select the exam, right-click, and select the
command [Edit Exam Data].

Figure 3-1: Editing Exam Data

This action opens a window in which the user may edit the date and time of the exam and enter the
name of a referring physician. Click OK to confirm the changes; otherwise, click Cancel.

3.4 Deleting an Examination


To eliminate a patient examination from the database, select the examination to be deleted by right-
clicking, then clicking and confirming the deletion request warning message.
Warning: deleting an examination also deletes all the images associated with it.

3.5 Refraction

When an exam is selected, the (Refraction) icon goes active. Selecting the Refraction icon opens a
window from which to enter the patient refraction data.

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Figure 3-2: Entering Refraction Data


Two labels permit opening the right eye (OD) or left eye (OS) chart. If the refraction value entered is
the value measured on eyeglasses and the corneal apex-to-lens distance is entered in the box for that
purpose, the system calculates the refraction at the corneal vertex. Enter the values of the sphere in
diopters (Sph), the cylinder in diopters (Cyl), the cylinder axis in degrees (Ax), and the distance to test

eyeglass in mm (@) in the relative fields. If the data is incomplete, the warning icon will appear.

If the data are correctly entered, the icon will be displayed.


The patient’s natural visual acuity is entered in the UCVA (Uncorrected Visual Acuity) box; the
maximum visual acuity attainable with correction is entered in the BCVA (Best Corrected Visual
Acuity) box.
The [Cancel] button closes the window without saving the changes. To save the entered data, click the
[OK] button or press [Enter].

3.6 Capture

The Capture icon goes active when a new exam is created or when an empty exam is selected. It
permits selecting the instrument with which to capture the exam and accessing the capture
environment.

3.7 Image Gallery


When an exam previously stored as described above is called up, the Gallery window on the right-hand
side of the main screen will show the images relative to each exam as it is selected.
The images are subdivided by OD (right eye) and OS (left eye).

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Figure 3-3: Image Gallery

A type group may be defined for each eye in order to facilitate future searches.

Figure 3-4: Groups

Click the button to open the pull-down menu of the groups entered in the Settings/Groups menu (see
Chapter 19). To enter the eye being examined in a yet-to-be-defined group, select <new group> to
open a box in which to enter the name of the new group.
Select a group. The buttons permit associating the right eye group with the left, and vice-versa.

Clicking an image displays a preview of the summary of the selected examination in the lower portion
of the screen.
Double-clicking an image opens the processed image summary (Chapter 5).
Right-click a gallery image and select to add a brief description.
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To eliminate an image, click .

To open an image, double-click with the left mouse key or press Enter:

 If the selected image is a previously-processed map, the topographic maps viewing environment
will open.
 If the selected image is a still-to-be-processed Scheimpflug capture, the image is first processed
and the summary environment is then opened
 If the selected image is pupillographic, the pupillography examination will open.
 If the selected image is an image acquired with the slit lamp, the image viewing environment
will open.

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4 Settings
The Settings menu may be accessed only if the Patients List is not displayed on the main screen. Click

the button to empty the patients list. Then click or open the File menu and select
Settings.

4.1 Language
After selecting Settings, the menu for setting the system language will open.

Figure 4-1: Settings

Select the language to be used by the software and click [OK].

4.2 Groups
For creating, editing, or deleting groups of examinations.
Cataloguing the examinations by homogeneous type groups (for example: keratoconus, PRK myopia,
PPK hypermetrophy, trauma, etc.) is useful as a search aid.

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Figure 4-2: Groups Menu

Click the button to insert a new group.

The button can be used to edit pre-existing groups. This button goes active when a group is
selected for editing.

The button is instead used to delete a group. It goes active when a group is selected for deletion.

4.3 Miscellaneous (Other)


Clicking [Other] accesses the window shown below:

Figure 4-3: Other Information Menu

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Database

Click the unlock button to change image root and Database


Image root: Clicking the button in this section selects the image management file called
root.cso.

Database: Using the button to select a file from the database phoenix.mdb.

Backup in: Using the button you can choose the destination folder fo backup files. You
can choose the maximum number of backups to perform.

Patient Management
Deselecting Patient ID (external option box) also deselects the other two options (mode and
PMS) and it will be possible to insert the ID code at the moment a patient is created.
If this option box is instead selected, it will not be possible to enter the ID code manually.
Select one of the following two options:
 Modality: the ID code is automatically assigned by Phoenix when a patient is created.
 PMS: The ID code and relative personal data will be crossloaded to Phoenix from an
external database. The ID of the agency or institution providing the data must be entered
in the field alongside the PMS item.

Note that in the latter case, the patient entry icon is not active.

Reminder
The user may select among the following options:
 Close application: displays the message requesting confirmation to close the application.
 Delete: displays the message requesting confirmation to delete an image from the gallery
 Series error: this warning is given when traces of images erroneously moved to other
folders or files remain in the examination in question.
 Assign group: after performing an acquisition a reminder is presented for classification
(group assignment) of the assigned series
Performance
Max exams returned sets a limit to the maximum number of examinations upon database
queries. Might be set in case of network environment, to tune performance.

4.4 DICOM (Digital Imaging and Communication in Medicine)

DICOM is a medical computer standard adopted by many health agencies and hospitals in all parts of
the world, which permits medical operators to exchange images and other information via computer
systems adopting this standard.
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Deselect the “Suppress DICOM messages” box to show any errors that do not interfere with image
capture.

Figure 4-4: DICOM

If DICOM is instead selected, the remaining menus must be used.

Figure 4-5:

Click the PACS or PMS button to open the following windows:

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Figure 4-6: PACS and PMS Configuration

This window allows the user to identify the PACS system that will receive his information or the PMS
system from which information may be requested.
In the relative fields, enter:
 Title: PACS/PMS ID.
 Host: PACS/PMS IP address.
 Port: PC port to which PACS/PMS is referred.
 Timeout(s): maximum waiting time before disconnecting a call.
 Limit: for PMS configuration only, identifies the maximum number of exams that may be
received. If the field is left blank, any number of exams may be received.

Clock [OK] to save the settings as entered; otherwise click [Cancel].


Click [Ping] to initiate a call to the PACS/PMS system.
Click [Reset] to remove PACS/PMS Setting

Under local you can configure the local Application Entity name and port.

Figure 4-7: Save Parameters

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The Save Parameters allow the user to specify several data storage options:
 Storage commitment: select to receive a computer receipt for the data sent. Fill in the Port and
Receiving PC fields.
 Lossless: select this box to select the type of compression used for sending, in a 5% to 100%
ratio in 5% steps, in .jpeg format. Otherwise, the files are sent in the original, uncompressed
format. Note that this principal is based on a best-first algorithm: when images are originally
acquired uncompressed, all compression options can be performed; when the image is acquired
lossless, it can be forwarded also lossy, but not uncompressed; finally, when the image is
acquired lossy, it can’t be forwarded other than lossy.

Figure 4-8: Java Runtime Environment

This parameter, defining the environment required for using the functions offered by DICOM, is
configured at end of software installation.

4.5 Instruments

Clicking the Instruments label accesses the section for managing the instruments to be used.

Figure 4-9: Instruments Management Figure 4-10: Installed instruments

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Connect all the instruments to use and press the Instruments wizard button .
You will see the next window with the instruments installed.

Press the Configure button to modify the settings. You will see the Figure 4-11.

The button permits inserting manually a new instrument for use. The instruments must be
inserted using the wizard.

Figure 4-11: Inserting a New Instrument

Enter the model name (reported alongside the exam) and an Executable File (select the SCLive
executable file), then select the class from the pull-down window shown in Figure 4-11. When done,
click [OK].

After the system has automatically installed the instruments Scheimpflug camera and topographer, it
will start the first calibration, (see the next paragraph).

The button permits editing an existing instrument.


To eliminate an instrument from the list, select it and click .

Click the button to calibrate the instrument. For calibrating, see next paragraph.
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In the following setting, you can choose whether to set a timeout in choosing the instrument (5
seconds), after which the instrument’s live application will be launched automatically. When not
checked, the acquisition choice screen will be shown until the user makes his choice.

Figure 4-12: Choice time-out

4.6 Activations
In this section it is possible to upgrade the license of the software.
In the section Export it is possible to enable the data export to external applications.

Figure 4-13: Activation settings

For a number of external applications it is possible to configure the export on the main gallery. The
default can be chosen from the combo box. Check the reminder if you want a reminder message for
exporting both eyes contemporarily to the external application.

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5 Capture
The Capture icon goes active when a new exam is created or when an empty exam is selected.
This function allows the user to select the instrument with which to capture the examination and to
access the capture environment.

Capture Screen Toolbar

BUTTON ICON FUNCTION

Laterality Automatic OD–OS recognition

Settings Accesses video camera settings

Acoustic signal You can choose the acoustic sound of the


acquisition
checking the box the instrument recognizes
R/L eye recognize automatically the Left/Right eye otherwise the
selection is manual

Esc Exits the Capture screen

Figure 5-1: Toolbar Buttons Summary

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The screen shown below will open.

Figure 5-2: Capture Window

5.1 Capture settings

Click the Settings button to view the commands relative to camera drivers, acoustic signal and L/R
recognize.

Figure 5-3: Settings screen

This panel is used:


 For installing the camera drivers. Connect the instrument and press the Install drivers button
(use the wizard to install correctly the instrument).
 For choosing the acoustic feedback when you capture an image.
 For setting the Autodetect L/R

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Otherwise select the OD or OS eye and then press button (Figure 5-4). The images will be saved in
the gallery with the assigned laterality.

Figure 5-4: OD-OS selection

5.2 Photo Capture

Create a new exam or open an existing one, and you will see the next window.

Figure 5-5: Acquisition screen

Press the joystick button opening the acquiring window.


Suggest looking at the fixation point in the instrument’s viewing channel.
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The system notices the left or right eye.

Move the slit lamp until you see the ocular cross in the pupil center.

Figure 5-6: Cross position

Focus the lightest slit reflex aligning it with the vertical cross line (Figure 5-6). Press another time the
joystick button acquiring the image.
Watching inside the ocular, put the brighter slit (the one you can see on the right) in focus on the right
iris border and overlapped the cross. Move slowly the slit lamp until you will see the endothelium cells
in the PC monitor.
Increase the light and search the best images with tiny lamp movements.
When you think to have captured some good images press the joystick button finishing the acquisition.

Figure 5-7: Images in gallery


The best images will be shown in the gallery. Select the images you want to archive.

The unselected images will be lost. Close the window pressing the button.

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6 Image Gallery Management

Double click any image in gallery to open the image management and processing screen.

Figure 6-1: Image elaborating

After having started automatic cell count, the operator must verify that the borders identified by the
software correspond to the real borders visible on the screen. If the software has skipped or erroneously
identified some cell borders, these may be manually modified or added by the operator. The better the
correspondence between the real and the identified borders, the higher the reliability of the results.

The mouse allows to:


- Delete the borders of the cells with right double click
- Add new borders with left click.

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6.1 Toolbar Buttons Summary

BUTTON KEYSTROKE ICON FUNCTION


SHORTCUT

Print -
Prints the processed images.

Analysis F2 Shows the processed images after editing

Edit F3 Allows the user to edit cells

Image F4 Modifies the image display parameters

Comparison Allows the user to compare two processed images

Save and Close Saves and closing processing

Polymegathism CTRL+Y Presents polymegatism processing results

Pleomorphism CTRL+H Presents pleomorphism processing results

Figure 6-2: Toolbar buttons

6.2 Editing selecting cells

To access the cell modification functions, click the button or open the menu
The menu bar at the top of the main screen lists the following menu (Figure 6-3) and select Edit.

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Figure 6-3: Editing menu


To view all the areas of the endothelium, scroll the image with the up ↑ and down ↓ keyboard arrows
or hold down Alt keyboard and the left mouse key and drag the image. The figure on the upper left
indicates the portion analyzed.

To add a point to a cell border in the image, simply left-click. On double clicking the right mouse key,
the point closest to the cursor is deleted.
When a point remains isolated and is not part of a complete cell, it will be displayed in yellow.

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Figure 6-4: Edit cells

6.3 Deleting cells

Open the Edit menu and select Delete. Hold down the left mouse key to display a circular red cursor.
As this cursor is moved over the image it deletes all the cells it touches (Figure 6-5).
To delete all the cells, select Delete all cells.
To re-edit the cells, click Reprocess.

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Figure 6-5: Delete cells

6.4 Editing image parameters

Click the button to display the unprocessed image of the endothelium in the foreground.

To return to the processed image, click the button.

Clicking the arrow at the side of the image button opens a menu (Figure 6-6)

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Figure 6-6: Image menu

The Image function corresponds to the function described at the start of this section.

Cell-scale shows the density and cell mean cell area. Scrolling with the mouse wheel, displays all the
dimensions and the color reported in the scale at the side (Figure 6-7)

Figure 6-7: Scale

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The Figure 6-8 functions allow the user to change the image settings to better recognize the border
cells.

Figure 6-8: Image parameters

To eliminate any modifications made, select Restore.

6.5 Analysis

Click the button to process an image. Two types of processing modes will be
presented:

- Pleomorphism: image by number of sides per cell. (Figure 6-9)

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Figure 6-9: Pleomorphism

- Polymegathism: image displayed by surface area of each cell (Figure 6-10)

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Figure 6-10: Polymegathism

To access the two processing types, open the pull-down menu from the analysis button and select the
desired item (Figure 6-11)

Figure 6-11: Analysis menu

Or click button

or button

displayed on the right-hand side of the screen above the relative diagrams.
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The reference scales for polymegathism and for pleomorphism are shown on the left-hand side of the
screen.

6.6 Analysis results

The processing window on the right-hand side of the screen displays the graphs and numerical results.

Figure 6-12: Analysis results

The Polymegathism graph presents the number of cells having like numbers of sides, corresponding to
the scale.

Cells: the number of cells counted for processing.

Total area: the area of the endothelium surface processed.

SEM (Standard error of the Mean): evaluates the reliability of the measurement by comparing sample
variability (standard deviation of the area) with the number of elements measured:

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Reliability index: it indicates the percentage of the analisys reliability. This number is green when the
valure is major of 50%, is yellow from 30% to 50% and red for not reliability analisys: the value is
minor of 30%. In the last case you will see the next message:

Area: (AVG±SD): average cell surface area with uncertainty given by standard deviation.

Density: density is given in cells per square millimeter [cell/mm2]. An indicative normal value for a
young male is 2500-3000 cells/mm2.

CV (Coefficient of Variation): cell morphology is expressed using the Coefficient of Variation (CV),
which is the ratio between the observed standard and the arithmetic mean of all the cells examined.
With reference to the Matsuda-Schultz index, an average value is less than 35.

Ex (hexagonality index): the ratio between the hexagonal (6-sided) cells and the total highlighted cells.

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6.7 Comparison

The system allows the user to compare two captures. This function is especially useful for monitoring a
patient’s progress or the evolution of a pathology, or for comparing the pre- and post-treatment
condition of the cornea.

Figure 6-13: Selecting images for comparison

To access the Comparison function click the button on the processing toolbar.
Accessing the Comparison function opens the window shown in Figure 6-13.

Click the button at the top to select images of different examinations. Once the examination is
selected, the relative gallery images will appear.

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Double-click an image to be compared with the starting processing image. Only two images may be
compared at a time.
Click OK to confirm.

Figure 6-14: Image comparison

A screen comparing the two processed images will open. The numerical values and the graphs on the
right of the screen refer to the image highlighted by a red square.
To select the other image, simply click on the image or open the menu on the top right and select the
other image.

Figure 6-15: Choose image

In this case as well, there are two possible analysis types: Polymegathism and Polymorphism.

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7 Printing

Printing is possible for one or two images in comparison mode.

Click the

Figura 7-1: Report printing

Select the images to be printed by double-clicking images in the gallery on the right-hand side of the
screen. The selected images will be copied into the lower right-hand corner of the screen.
Printing is possible only if a printer is connected to the instrument.

Description of Print screen buttons:

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- The Refresh button shows modifications made to print settings.

- Settings allows the user to modify the print setup.

- Print allows the user to print the page shown in the preview.

- Enlarge – Reduce Preview

- Show/Hide Heading
displays or hides the heading (if inserted) and relative logo.

- Esc exits the Print screen.

- Edit opens the window shown in Figure 7-2: Company Data.

Figure 7-2: Company Data

Click the button to insert a logo.


Type the other company data in the empty fields as indicated on the screen.
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Click OK to confirm.
These data will go to make up the heading applied to all successive printouts unless later modified.

Printing can be done on paper or in PDF format. Press [Print] to print on paper, [PDF] to create a PDF
file. You can choose to save the PDF in the gallery by selecting [Yes]; selecting [No] will allow you to
save it elsewhere.

Figure 7-3: Save the report

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Appendix A. Introduction

1. INTRODUCTION
Thank you for having purchased CAPTURE by CSO.
All CSO products are manufactured to rigorous safety standards. In
particular, the CAPTURE specular microscope is a high-performance
instrument. In order to use it efficiently and in complete safety we
recommend reading this manual carefully before installing the instrument and
heeding all the safety warnings provided herein and on the instrument labels.
Even technicians who have already used this type of instrument should verify
their knowledge of the instructions contained in this manual. Keep this
manual near the instrument for handy reference during use.

2. BRIEF DESCRIPTION OF THE


INSTRUMENT – USES

The endothelium is the deep layer of the cornea. In a young subject it is


about 5 micrometers in thickness and contains about 300,000 hexagonal
LEGGERE cells.
ATTENTAMENTE The endothelium is important for correct corneal function; for this reason,
analysis of the endothelium is of fundamental importance for diagnosis of the
IL PRESENTE health of the eye.
MANUALE The most important characteristic of endothelial cells is their lack of
reproductive capacity; age, surgical treatment, and use of contact lenses are
factors influencing their quantity and form.
As already mentioned, the cells composing the endothelium are hexagonal in
children and younger people, do not reproduce, and their form and quantity
influence the health of the cornea. At birth, the endothelium contains about
2
4000 cells/mm ; with time, the number decreases and the structure of the
layer changes accordingly.
The CSO specular microscope permits obtaining electronic photographs of
the patient’s endothelium with no instrument/patient contact. The
endothelium image can then be mathematically processed to display
clinically-useful endothelial cell parameters such as cell number and density,
form, surface area, mean area, standard deviation, coefficient of variation,
percentage of cells of different forms, histogram of cell area distribution.

The CSO CAPTURE specular microscope permits performing:

 Non-invasive examination of the endothelial tissue.


 manual focusing of the endothelial layer of the cornea.
 Automatic search for cell borders and broad-based statistical
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analysis of the acquired data.

The CSO specular microscope is an indispensable aid in diagnosing corneal


health.
It is extremely useful in pre- and post-transplant examinations, post-cataract
surgery examination, and evaluation of trauma damage to the cornea.

Since examinations performed with the CSO specular microscope are totally
non-invasive with no patient contact:
 there is no risk of transmission of infectious diseases.
 the examinations are totally painless and do not require use of local
anesthetic.

The instrument is composed of:


the CAPTURE as such, designed and built by CSO, and the user
accessories listed below.
1. Firewire cable
2. sensor cable.
3. bearing.

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Appendix B. Import – Export Exams

1. Exporting an examination
Exporting an examination or a patient, select with right-button of the mouse on the examination and
click export.

Figura 8-1: Export examination

You will see the editing screen of the anagrafic data to be exported.
Edit the data if you want and select OK.
It will be exported the file.zcs.

Figura 8-2: File esportato

2. Importing an examination

To import a previously exported file.zcs, you must open the archive containing the file, and drag the
column occupied by the patient list, as shown in the next window:

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Appendix C. Safety

For data security, please refer to the management of Windows security.


It is recommended to enter a password to access the account used

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Appendix D. General Safety Precautions

1. General precautions

The unit are always supplied in optimal conditions packaged to


Warning withstand conditions of transport and storage standard. Where in busting
Before using the unit read with tool, is observed anomalies arising from the carriage, please contact the
attention all this manual and installation company directly or CSO srl. The endothelial microscope
particularly this chapter
“CAPTURE” had to be used together with the slit lamp and a personal
computer on which you have installed PHOENIX software.

It is recommend to:

 Ensure that the voltage of the electro system corresponds to the


requirements of the nameplate of the equipment supplied by the
mains.

 In the case of use in a local medical use of the entire facility must
be built, tested and kept under regular review in accordance with
CEI 64-8 sec. 710. In case of anyu doubt, seek the company of
the electrical installation and maintenance.

 Never use adapters or power strips or extension cords to connect


the plug to the outlet.
The symbol shown in the
figure and found on the exterior
of the instrument indicates that
To disconnect the power form the connected to the mains, even in case
the electrical and electronic
parts of the end-of-life
of emergency, hold the power cord plug, never pull the cord to
instrument must be separated disconnect the plug.
and disposed of as special
waste.
See the manual for the slip lamp, about the safety precautions in this
mark complete with the relative.
code number of the notified Never touch the power supply with wet hands, make sure that the same
organization (IMQ), certificate no. can not be walked on or pinched by weights.
811/MDD, furthermore Don’t damage the cord, it may cause fire or electric shock. It should be
guaranteeing .conformity of the
product according to European norm
checked frequently. In case you need to replace the supplied mains cable
93/42/CEE (medical devices). to the PC, ask to producer.

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Don’t perform any sort of technical operations on the plant or outside of


the provisions of this manual.
Don’t use the device near the water and be careful to not spill liquids in
any point of the unit. Avoid damp, dusty or subject to rapid changes in
temperature and humidity. Before to clean or disinfect the device,
disconnect it from the mains. The unit doesn’t generate or receive
electromagnetic interference in working close to other devices,
consequently does no require any preventive action.
The system together the CSO equipment (Slit lamp, Capture, …)
includes also no-medical electro equipment (PC, monitor, ….). In the
standard configuration provided by the CSO system is tested in
accordance with ch. 16 of EN 60601-1 (3rd edition). As compared to the
standard configuration, the system in question can still accommodate
other apparatus (electrical or otherwise), CSO hasn’t been able to verify
compliance with the standard configuration for all possible of them.
Warning The configuration verified by CSO srl is with personal computer outside
the patient area.
If you enter in the system other accessories (printer, scanner, modem,
….), connecting them to analog or digital interfaces, you must ensure
that they are certified according to the following standards:

 EN 60950-1 for equipment (ITE safety standard information


technology equipment), or
 EN 60601-1 for medical equipment; these units should be placed
outside the patient area.

2. Using precautions

Follow the precautions and warnings to ensure the correct use of


instrument.
Follow the maintenance instructions of this manual, to ensure the correct
functionality.
Verify that the fixation point is working properly before using the
instrument.

Take care to examine children or patients with transparent cornea; could


be impossible acquire images of these people.
Verify that the patient was correctly placed on chin rest and his frorehead
was in-contact with headrest.
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There are tissues whose endothelial acquisition presents considerable


difficulties and can follow up conflicting results.
These may be patients with irregularly shaped corneas, eyes, on the
eyelid or remove the tear before the exam.
The acquisition is not possible in the case of intraocular lenses.
The analysis and evaluation of the results must still be given to a health
specialist.

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Appendix E. Installation of the instrument

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LEGEND

1. Specular microscope
“CAPTURE”
2. bearing for slit lamp.
3. bearing rod.
4. Caller rest position.
5. Screw rest hinge
adjustment.
6. Magnet calling work
position.
7. Screw vertical adjustment.
8. Screw angle adjustment.
9. Connector SLIT
LAMP/CAPTURE
10. Firewire cable.
11. Viewing channel.
12. Blockage screw of the
support tile.
13. Slit opening adjustment.
14. Stop disk adjustment.
15. Filter disk adjustment.
16. Base blockage.
17. Acquiring button.
18. Light intensity adjustment.
19. Connector BASE/CAPTURE
for DX/SX eye.
20. Grain locking height

- Put up and block the bearing


of the CAPTURE in the high
part of the microscope. See
the figure.

Assemble the instrument on the


slit lamp orientating it like shown
the figure (Rest position).

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CONNECTING
CABLE :
ONLY CAPTURE

- GREEN= connecting cable


BASE/CAPTURE
- BLU= firewire cable
(PC/CAPTURE)

CONNECTING
CABLE :
WITH SLIT LAMP

- BLU= firewire cable


(PC/CAPTURE)
- RED= firewire cable
(DIGITAL
CAMERA/CAPTURE)

- GREEN= connecting cable


BASE/DIGITAL CAMERA

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Appendix F. Installing Capture


It is advised to follow the next procedure, performing the calibration, each time the microscope will be taken off.
1. Block the base using the pommel.
2. Assemble the ocular with the cross in the left channel.
3. Put up the microscope arm (up the joystick).
4. Insert the aim and orientate it perpendicular to the microscope axis. Using a slit of a few tenths of
millimeter, rotate the aim pommel until the slit projection is stationary during the overturning of the
lighting arm.
5. Rotate and block the lighting at 20° respect microscope arm (opposite part of you place the capture).
6. Insert the bearing (2) on the microscope and block it with the screw (12). Unscrew the two grains (20).
7. Assemble the capture in rest position. Connect the cable and after that put it in work position. (The two
magnet must be in contact). Check that isn’t present some dust.
8. The instrument calibration must be performed with the PC monitor. You need press the live button.
9. Select the stop to 0.3 mm.
10. Put the light spot in the middle of live window adjusting the pommel (8) and the screws (7).
11. Move the capture from bearing and screw the grains (20). After that replace the capture.
12. Select the stop to 3 mm.
13. Close the slit until it will be large about ¼ of live window.
14. Rotate the pommel behind the taim until the lighting slit will be about 0.5 – 1 cm near the left live edge.
15. Let the slit in this position and search the best focus rotating the pommel (8) and the pommel behind the
aim.
16. Block the screw up the pommel.
The CAPTURE is ready to use.

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Appendix G. Technical description


1. Technical features

Photographic method Non-contact


Photografic field 0.25mm x 0.5mm
Video camera CCD video camera
Illumination From slit lamp

Fixation point Yellow LED fixation


Working distance 50 mm
Size 165 x 140 x 100 mm
Weight 800 gr

2. Classification according to regulatory EN60601- 1/08/90

Type of protection against direct and in direct contacts: Class I

Level of protection against direct and in direct contacts: Type B

Level of protection against humidity: Common devices (no protection against water
infiltration

Method of sterilization: Disinfection of equipment

Level of protection in proximity to inflammable


Anesthetics and/or detergents: No protection

Use conditions: Continuous service

Level of electrical connection between instrument and patient: Device with applied parts

3. Reference standards:

EU Directives

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 DIRECTIVE 93/42/EEC “MEDICAL DEVICES ” of 14 June 1993.


 DIRECTIVE 2002/96/EC “Waste Electrical and Electronic Equipment (WEEE).”

Standards concerning Quality Management Systems


 UNI EN ISO 9001:2000 “Quality Management Systems – Requirements.”
 UNI EN ISO 13485:2004 “Medical Devices – Quality Management Systems - Clinical
Requirements for Regulatory Compliance.”

 The harmonized standards listed below are also applicable


 EN 60601-1 – “MEDICAL ELECTRICAL EQUIPMENT. PART 1 : GENERAL
REQUIREMENTS FOR SAFETY” as amended. Corresponding Italian standard: CEI
62-5 – 1991 edition – Record no. 1445.
 EN 60601-1-2. “Medical Electrical Equipment. Collateral standard: Electromagnetic
compatibility.” Corresponding Italian standard: CEI 62-50 - 2001 edition.
 EN 60601-1-1. “Collateral standard: Safety requirements for medical electrical systems”
as amended. Corresponding Italian standard: CEI 62-51 – 1994 edition – Record no. 2308.
 UNI EN ISO 15004 “Ophthalmologic Instruments – Basic Requirements and Verification
Methods.” 2000 edition
 UNI EN ISO 14971:2000 “Risk analysis application on medical devices.” 2000 edition

CSO srl
Costruzione Strumenti Oftalmici
Via degli Stagnacci, 12/E
50010 Badia a Settimo - Scandicci (FI)
tel. (055) 722191 - FAX (055) 721557
Email: support@csophthalmic.com

DISCLAIMER

Before performing an upgrade of the application or the archive, and / or at least before any
maintenance operation, to make a backup of the database.
It is also recommended you periodically (every week at least) a backup of a different medium from
that normally used (eg CD-ROM or DVD).
CSO srl disclaims all liability for loss of data due to improper handling of the archive.

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Appendix G. Import-Export exams

1. Exporting an examination
Exporting an examination or a patient, select with right-button of the mouse on the examination and
click export.

Figura 8-1: Export examination

You will see the editing screen of the anagrafic data to be exported.
Edit the data if you want and select OK.
It will be exported the file.zcs.

Figura 8-2: File esportato

2. Importing an examination

To import a previously exported file.zcs, you must open the archive containing the file, and drag the
column occupied by the patient list, as shown in the next window:

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Figura 8-3: Import file

Wait a few seconds and the patient will appear in the list.

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Appendix H. Safety

For data security, please refer to the management of Windows security.


It is recommended to enter a password to access the account used.

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Appendix I. Configure PViewer (iPad)

In order to use Phoenix with Pviewer1, follow these instructions. First you will install the service host,
that exposes Phoenix’ Patient information, then you will configure the iPad to discover that information
through a wireless connection.

How to configure Phoenix


From the WCF Service menu in your start menu, choose Install PSvcHost.

The following screen might appear. Choose no, since your Phoenix CD already contains the framework
.Net 4.0 installation.

1
Available on https://itunes.apple.com/it/app/pviewer/id571848602
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In the following directory you will find the setup for Microsoft Framework .Net 4.0 (Full).

After the framework is installed, try again to install the PSvcHost.

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How to configure your iPad

Select the wireless network available for interaction with Phoenix.

This network by default will be configured as follows:

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Make sure the address is configured as static, and the IP address is on the same netmask as the host
computer. Since typically the host computer will be configured as having address 192.168.10.10, this
means that the iPad must have an address similar to 192.168.10.*. The host computer will be
configured on your iPad as the router.
Following the button in the upper right corner of the main screen, the address of the host computer (and
port it listens to) are to be configured.

The default configuration is IP: 192.168.10.10, port 5100.

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Create an ad hoc wireless connection


For indications on how to create an ad hoc wireless connection on Windows XP, see below

You can create an ad hoc wireless connection on the host computer to access through wifi the web
service. In order to create the adhoc connection, follow these steps:

The new network will be created starting from the network connections on the control panel. The
limitations of the ad hoc network are illustrated below (for instance maximum distance between client
and host should be 10 meters); therefore, the configuration of an ad hoc wireless connection is only for
demonstration purposes.

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Define the network ‘Cobra’ without authentication, and make sure to save the connection (indicated by
the checkbox as shown below).

Next, configure the network’s IP settings. The IP Address assigned will be the router on client
computers.

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Finally, in order to make sure the ad hoc connection is started automatically on computer startup, save
the following command
netsh wlan connect name="Cobra"
In a file in automatic execution on the start menu.

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Ad hoc connections on windows XP


From the network connections panel. Choose the properties for the wireless connection adapter.

Choose add… under preferred networks

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And set the IP settings as described above.

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