G-197, Sector-63, Gautam Buddha Nagar
Uttar Pradesh, India-201301
Meddevices Lifesciences
B.V.Keizersgracht 482,
1017 EG Amsterdam, the Netherlands
Operator’s Manual Ver: 20.1
- 1 -
DVC-IMS-019
Page 2
1 Check
your delivery
3
3 INSTALLATION
7-11
5 NEW
CHECK
21-28
6 EDIT CHECK
29
9 STATISTICS
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This manual contains information, which may not be copied or duplicated, in full or in part, without the explicit approval of Divine Meditech Pvt Ltd. India. We reserve
the right to make any change in the user manual, which may affect instructions in this manual, without giving prior notice. The user of this software shall be solely
responsible for any kind of malfunction to the software as a result of improper use by anyone other than us or a technician duly authorized by the manufacturer to do
so. This operator manual provides directions for using COLpro222DX-OZview Colposcopy Software. Read all instructions prior to use. Failure to follow instructions
could lead to malfunction of the software. The software is intended to be used by qualified Gynecologist with expertise in colposcopy, forensic interpretations, and
analysis. They are entirely responsible for any analysis or reporting using this software.
Intended Use
store edit, print the detailed reports.
: The Colposcope Software ref DVC-IMS-019 is intended to manage videos, image, clinical data and details of the patients and provide facility to
INDEX
SECTION
2
4
7
PARTICULARS
Pre-Check
Hardware & Computer settings
Settings in Windows 7/8/10/11 and
Vista
INSTALLING SUPPORT DRIVERS /
TOOLS
5.1
5.2
5.3
Screen
LOG-IN & Input New Patient Data
Patient’s Other Details Entry
Colposcopy Live Video Procedure
Software:
Operating System: Window Vista or Window 7 or Window 8 or Window 10 or Window 11
MS office
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(Above requirements are subject to change without prior notice due to continuous up gradation in the software, please contact Divine Meditech
Pvt. Ltd. to get the exact requirements).
Check Computer Settings:
On your desktop screen, Click on
START
, then click on
CONTROL PANEL
.
4
Click on
USER ACCOUNTS AND FAMILY SAFETY
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Click on
USER ACCOUNTS
5
Click on
TURN USER ACCOUNT CONTROL ON OR OFF
(last line of the window)
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For installation in operating system - WINDOWS VISTA
Uncheck the box –
PRESS OK AND RESTART THE COMPUTER.
USE USER ACCOUNT CONTROL (UAC) TO HELP PROTECT YOUR COMPUTER
6
.
Ensure this box is not ticked
For installation in operating system - WINDOWS 7, Window 8, Window 10 and Window 11
SAME STEP - Click on
Drag the BAR down from
PRESS OK AND RESTART THE COMPUTER.
TURN USER ACCOUNT CONTROL ON OR OFF
ALWAYS NOTIFY
to
NEVER NOTIFY
.
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INSTALLATION
SECTION
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For installation in operating system – WINDOWS Vista–
USER ACCOUNT CONTROL should be always off
Please do not attach the Video Grabber Card Before completion of Installation.
A.
Insert the installation CD, it will auto play / display the below screen (INSTALLATION SCREEN)
B.
Click COLpro222DX-OZVIEW.NET icon.
7
C. Click Accept icon on below window.
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D.
Click Next Icon on below window.
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E.
Click Next Icon on below window. This will start the installation.
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F.
Click Close on the below window.
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G.
Click on
Video Driver in
below window.
H.
Click next on below window
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10
I.
Click on finish icon in below window.
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J.
Yes, I want to restart my computer now and Press Finish.
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When INSTALLATION IS FINISHED, an icon of COLpro222DX-OZVIEW will appear on your desktop.
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INSTALLING
SUPPORT
DRIVERS
/
TOOLS
SECTION
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A.
Click on
VIDEO SUPPORTICON
and click NEXT
B.
Tick I ACCEPT THE AGREEMENT and click NEXT
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C.
Click NEXT
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D.
Click INSTALL and after installation click FINISH.
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E.
Click
ICON VIDEO PLAYER SUPPORT
and click NEXT on the below window.
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F.
Click NEXT.
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G.
Click INSTALL.
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H.
Installing window will appear.
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I.
Click FINISH.
A.
Click
TEAM VIEWER SOFTWARE
and click NEXT on the below window.
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B.
SELECT…I accept the terms in the license agreement and click NEXT.
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C.
SELECT…Install Team Viewer and click NEXT.
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D.
DO NOT ENTER ANYTHING in the below window, just click NEXT.
E.
click NEXT.
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F.
Click INSTALL.
G.
INSTALLING window will start.
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H.
Click FINISH.
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I.
Below Team Viewer WINDOW will appear, DO NOT PUT ANYTHING, just close this window. You can use this application
from Programs list in your computer in the future for any technical help needed with pre-appointment.
J.
Similarly Click and install POWER DVD SOFTWARE, if your computer does not have CD/DVD BURNING Software.
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NEW
CHECK
SECTIN
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5.1 Log In & Input New Patient Data.
Log-in Screen
Installation Screen will appear
Double click “System” on the User list which is
available in the software by default.
Password: Enter the password “sys” (which is set by
default)
Ok : to Login to the Main Screen
Cancel: to Exit from the application.
This section deals with performing colposcopy of a patient visiting the Clinic for the first time. When the “NEW CHECK” button is
clicked on the installation screen, the below screen will appear .
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Save the patient Data.
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Reg No: Enter Patient’s Registration no or any
valid ID no. you wish to enter.
Name: Name of the patient
Age: Patient’s Age
Date: Date of Colposcopy Procedure
Ref By: Doctor referring the Patient for
colposcopy
Doc Name: Select the Dr / user who is
performing the procedure
Click this icon to add more Users
Click to add More Pat. Details
Click to add a New Patient.
Click to edit a Patient’s Detail selected from the Grid.
Click to delete a patient’s Detail selected the Grid.
Click to go to the next screen where Live Colposcopy video available for capturing images.
Exit the Screen.
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5.2 Patient’s Other Details Entry
The Patient details like Reg No, Check
date, Create Date, Name, Age are
fetched automatically.
The Other clinical Details of relevance
shall be put like Birth date // Last
Menstrual Date // HCG etc.
Save Button: Save the changes. Exit
Button: Exit the screen.
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5.3
Colposcopy Live Video Procedure Screen
Click on Capture then below screen will appear after that press Play button for live video
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By clicking on the “
Setting
” button, the following screen appears. Detailed descriptions are as below.
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Click on Set button in above screen live colposcopy screen will appear
Live Video
Foot Switch: A Footswitch is used to capture an image.
Function Key F3- is used to start the video recording.
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Click to add More Pat. Details (Ref
sect 5.2 )
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Click to capture the Images. The
captured images will be saved in
the right hand side frames
Click to start Video Recoding of the
Colposcopy session.
appear
display the frame count and Drop
Frame count.
Click to view Live Video on FULL
SCREEN OR simply use Function
Key F10
Click to go to “SETTING” screen
where various video related settings
are done.
Click to play for view live video
Click to View captured Images
REF
will
will
Click to stop the Video Recording
session or Simply use Function
Key F4
Click to go to the Report Section
Click to open “GRABBER CARD
“properties screen.
Click to view recorded videos.
You can play a video by double
clicking it.
Captured Images “MOVE UP “
Captured Images “MOVE DOWN “
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5.3.1 SETTINGS
5.3.1. 1 Device Name :
The box will display the name of the Video Grabber card // imaging devices that are attached to the computer.
Ideally it should be “Vcap 2860 “. But sometimes there are imaging devices like web camera which is also available. Due to this,
Live Video may not be captured. In that case, the solution would be to disable the Web Camera from Device manager in your
computer.
5.3.1. 2 VIDEO FORMAT:
It is Video resolution that is supported by
the Grabber Card.
Ideal choice would be to select YUY2 640
* 480 (NTSC & PAL-B)
or YUY2 720 * 576 (PAL B)
5.3.1.3 VIDEO INPUT :
It is the mode of the Video signal from the
Colposcope System.
It could be either VIDEO COMPOSITE or
S-Video
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5.3.1.4 VIDEO STANDARD :
It is the video standard of the input video signal. It can be either PAL – B or NTSC – M.
5.3.1.5 VIDEO RECORDING SETTINGS
In this software, there is facility to record live video during the colposcopy session.
The Video could be recorded using three different recording formats.
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5.3.1.5.a. AVI Mode:
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In this mode, video is recorded with file
extension of .avi. This .avi file formatted
video is good in small resolutions, i.e; up
to 320* 240 resolutions. If higher
resolution is chosen, the video recording
quality gets deteriorated.
Screen Snapshot appearance, when AVI
mode is selected.
USE AUDIO COMPRESSOR must
be ticked ON.
Choose “PCM” Audio compressor.
“Use Video Compressor “ option
should be ticked
The ideal compressor would be
“indeo@video 5.10 “or Microsoft
Video 1.
ON
5.3.1.5.b.
*** This mode is not very popular and the videos are not played by many media players.
WMV Mode (WINDOWS MEDIA VIDEO)
5.3.1.5.c.
MPEG Mode (IDEALFOR SUPERIOR QUALITY RECORDING)
In this mode, video is recorded with file extension of .MPEG.
There are two types of MPEG options
MPEG-1 // MPEG-2
*** Suitable MPEG Encoders and Decoders are to be installed on the PC to for the MPEG files to play. Installing POWER
DVD which is provided in the installation CD will resolve this issue. ***
MPEG-1:
MPEG-2:
Screen Snapshot appearance when MPEG mode is selected.
This mode is ideal for smaller resolution recordings only.
This mode is ideal for High resolution recordings.
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MPEG: Choose between MPEG-1 or MPEG-2
Video Bit Rate: Ideally it should be at 4600000 OR it can range between 1500000 to 5000000
Higher the Bit Rate, higher will be the file size of the video recorded.
Audio Bit Rate: set it at 224000.
Frame Rate: It is the no. of frames captured per second. It should be at 25.
Audio Sampling Rate: 44100
Audio Channels: 2.
Width: Please input the desired width of the video being recorded like 640
Height: Please input the desired height of the video being recorded like 680
5.3.1.6 TEXT ANNOTATION ON THE LIVE VIDEO.
The software provides facility to add text on the live video at any desired location, font, style, color, at any desired location.
The location can be specified as LEFT and TOP.
PROPERTIES:
When the “PROPERTIES” button is clicked, Properties window of the Grabber Card will appear.
The user will be able to adjust // modify various properties of the Grabber Card.
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EDIT
CHECK
SECTION
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The EDIT CHECK option is used for Patients whose subsequent colposcopy data needs to be maintained. The software
maintains colposcopy data performed on different dates for particular patient in separate date folders under main Patient folder.
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Patient Search
Name : Enter the Patient’s Name
Start Date : Choose date from where search should start.
End Date : Choose date from where search should stop
Search : Click to execute the search criteria
All : Click to view all data.
Clear : Clear the search criteria.
Details data : Click to add More Pat. Details
Capture : Click to go to the next screen where Live
Colposcopy video available for capturing images.
Exit ; Exit Screen
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REPORT
SECTION
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7.1 SEARCH REPORT CASE
7.1.1 Shortcut Search
Today: The grid will display current date’s patient data only.
Month: The grid will display current Month’s patient data only.
Year: The grid will display current year’s patient data only.
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7.1.2 Search
Name : Enter the Patient’s Name
Reg No : Enter the Patient’s Registration No.
Start Date : Choose date from where search
should start.
End Date : Choose date from where search
should Stop
Search : Click to execute the search criteria
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7.1.3
Patient Data
All : Click to view all data.
Clear : Clear the search criteria.
When the patient is selected from the grid, the patient’s complete data is fetched in
the following area. The Data includes Basic Details, Diagnosis, Images etc.
Detail Report : By clicking this button, it displays the patient’s report data
Details data: Click to add More Pat. Details
CD – W : It help to create a Patient CD
Report : Create a report
Exit : Exit the screen
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7.2 Case Report
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When the Case Report Screen is opened, the first four images that are captured will automatically fill the four image boxes. On
the left side, there are many buttons each pointing to certain functionality. Each activity is detailed below.
7.2.1 Details data : Click to add More Patient Details
7.2.2 Report:
Under the heading of Patient Data (DIALOG BOX), few headings like Chief Complaint, Cytology Report, Colposcopy Findings,
and Treatment etc. are available.
By clicking on any of the heading, its respective Item contents (DIALOG BOX), are available in the List Box with selection option.
It enables the user to tick the required option.
Press Function Key F9 to add a new Data, by first setting the focus on the list box. It will open the Master Data Screen.
When the Report Button is pressed, the Case Report Designer Screen appears as below.
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Hide Reference: By clicking this button, the Reference Picture from the library will disappear.
LEFT SIDE PICTURE: shows current patient’s images to match with RIGHT SIDE PICTURE from the library.
Clear Diagnosis: By clicking this button, the Diagnosis box will be cleared.
By clicking the Show Result Button,
A screen will appear where the chosen data is displayed in the
text format.
Exit: Exit Screen.
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7.2.3
Sexual Assault:
The functioning of this screen is same as the Case Report Designer.
7.2.4
Cryo Surgery:
The functioning of this screen is same as the Case Report Designer
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7.2.5
Hysteroscopy: This Screen Help Keep Data of Hysteroscopy procedure,
7.2.6
LEEP / LEITZ:
This screen helps to keep data of LEEP Operation record
.
Diagnosis Before Operation: Enter the diagnosis of the patient before LEEP operation.
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Operation Record
Anesthesia Mode: No // Local anesthesia // Intravenous Anesthesia // Others.
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Operation Time : Operation Time selection through combo box.
Operation Deepness: Choose the value in mm from the combo box.
Days After Operation: No of days of Hospital stay.
Operation Range: Height (mm) * width (mm) shall be put.
Bleeding while Operation: Select M=ml value from the combo box
Operation Mode: Choose any one option from Single Pass // MultiPass // Cowboy Final // MultiPass +Cowboy Final
Pathology Result After Operation: Text Box Entry.
7.2.7
COMPARE
This software offers facility to compare the patient images and data with other patient’s data, images and reports which
helps the user, while preparing the Report.
The Comparison option is available in three types.
7.2.7. A. Compare with Own Patient Data
In this option, the User will be able to compare the patient images with his other patient’s Data by using several search criteria.
The Screen snapshot is below.
The Patient search offers criteria option based on Name, Reg No, Start date, End date, Diagnosis, Report Data, and Sub Data.
Diagnosis :
Tick the Checkbox. The Combo Box will be filled with
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all diagnosis data.
Choose the Diagnosis data which is required for the
search.
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Search : Click to execute the search criteria
All : Click to view all data.
Clear : Clear the search criteria.
Exit : Exit Screen
Report Data :
Tick the Checkbox. The Combo Box will be filled with
all report data.
Choose the Report data which is required for the
search.
Sub Report Data :
After selecting the Report Data, the Combo Box will be
filled with all Sub Report data associated with the
selected Report Data.
Choose the Sub Report data which is required for the
search.
7.2.7.B. Compare with Library.
This option gives the user more power packed comparison of the patient data with a library of hundreds of interlinked images.
Each image carries the attributes like Diagnosis, Colposcopic Observation, Text Description etc.
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By clicking on the “Colposcopic Image Reference “the following screen appears
There are two list boxes available. The List box on Left is filled with “Possible Colposcopic Observations”. The user can choose
as many options as possible. Same way, the List Box on the Right is filled with Possible Diagnosis”
WORD SEARCH: The user is also able to search by word.
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IN THIS SCREEN, THE USER CAN CHOOSE ANY NUMBER OF CHOICES ON ALL. THE SOFTWARE WILL SEARCH FOR
IMAGES FORM THE LIBRARY AND PROVIDE WITH ALL IMAGES MEETING ALL SEARCH CRITERIA.
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Chosen Search criteria from the previous screen
Each image from the Library is interlinked to a set of other images. Suppose a library image is depicting
“Condyloma “ ,
images linked to that image , leading the experts to reach to a conclusion of the specified Diagnosis.
diagnosis , if we DoubleClick on that image , we will be directed to another screen where it shows all other
Attributes of the Library Image like
Appropriate Colposcopic Observation // Diagnosis //
Text Description.
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7.2.7.C REFERENCE VIDEOS
Click on any of Reference Videos and the Procedure video will be played.
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7.2.8
The Software offers facility to perform various activities on the captured images like masking, adjusting contrast, brightness,
lesion marking and measurements, LEEP Marking etc. The Following parts of this section deals with various functionalities
related to this topic.
When “Marking “button is clicked, the following screen appears.
By selecting “Image Label “, the above shown screen will appear. Double Click on any of the image. Selection screen will
appear with option for “Masking” or “Adjust Contrast or Brightness”
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7.2.8.A-1 Masking
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The selected Image is available on the Masking area. Tool Bars are available to perform various masking operations.
Insert styled arrows at any desired location of the image.
Click on this icon and Draw Line on
the Image
Click on this icon and Draw CIRCLE
on the Image
Click on this icon and Draw
RECTANGLE on the Image
Click on this icon and ZOOM a
particular area on the Image
Click on this icon and write TEXT at any
desired location
Click on this icon and UNDO a previous activity
done on the Image
Click on this icon and REDO a previous activity
done on the Image
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Select a particular AREA on the
image.
Click on this icon and crop the other areas
other than the selected area
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To open the Font toolbar to modify the
7.2.8.A-2 Adjust Contrast / Brightness
Text annotation.
Zoom the entire image to any desired
level up to 500 times.
Rotate the image to 360degrees, in step of 90
degrees.
The user can adjust the Brightness and contrast at desired levels.
OK - Save the changes.
Cancel - close the screen.
Undo - Undo the changes.
A. Biopsy Label
The following screen is used to draw Hammond Graph or Biopsy labeling.
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B. Hammond Graph Plotting
Click on the required definition like Po=polyp or M=Mosaic etc., drag it and drop it (by clicking on the desired location) on the
graph.
Save: Save the Changes. Clear All: Clear all changes without saving. Undo : Undo the recent change.
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C.
LEEP / LEITZ Label
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Click on the required definition, drag it and drop it on the desired location on the graph.
Ok : Save the Changes. Clear All : Clear all changes without saving.
Undo : Undo the recent change. Exit : Exit the screen
D. MEASUREMENTS
The following screen appears when the MEASUREMENTS option is selected. The User can select an image and mark a line or
area and it will provide the length in mm and the area in mm2.Before measurement is done, the user can calibrate the length by
performing SCALE operation.
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E. SCALE :
When Scale is selected, the following screen area will appear. The user can draw a line horizontally. An input box will appear
where the user has to enter the equivalent value in mm for the line drawn. The software will automatically calibrate PIXEL to MM
ratio.
7.2.9. Image Selection
Whenever Report Designer Screen is opened, the Software chooses the first four images captured, and place them into the
IMAGE boxes required for printing. But, the user can drag any image from the list and drop it in any of the IMAGE BOXES.
7.2.10. Report Selection :
choose the Report Format.
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7.2.11 Preview : When the Preview button is clicked, Print Mode Screen will appear, click Select
Select the Printer Name. And click OK….
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Print Preview Screen will appear
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SAMPLE COLPOSCOPY REPORT
THREE IMAGES
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SAMPLE COLPOSCOPY REPORT
FOUR IMAGES
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SAMPLE COLPOSCOPY REPORT
LEEP OPERATION
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SAMPLE COLPOSCOPY REPORT
COMPREHENSIVE REPORT WITH 4 IMAGES
Easy report: If you prefer to make report in
your own hand writing, you may do so using
easy report option.
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MASTER
DATA
MANAGEMENT
SECTION
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8.1 Report Master
When Report Master Button is clicked the above screen will appear. There are two sections.
The one on the top is Header Section and the other on the bottom is Details section.
a.
“New “ Button : By clicking on this button, the below screen will appear where we can add a New Header
b.
“Edit” Button : By clicking on this button, we can edit any already existing Header.
c.
“Delete” Button: By clicking on this button, we can delete any selected record.
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8.2 Ref By Doctor
When Ref By Doctor Button is pressed, the following screen appears which allows the User to enter new Doctor’s Name,
Address, age, mobile no etc.
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8.3 Report Image Setting
The software offers facility to adjust the size of the images on the report before printing, according to the user’s choice. When
“Report Image setting “button is pressed the following Screen appears.
Select a particular Report from the List (Left side), it will display the previous setting of the images in that report. Change the
values if required. Click on “Preview” button to have a preview of the images that will be shown on the report.
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8.4 Diagnosis
When “Diagnosis” Button is pressed, the following entry screen will appear. It will enable the user to add new diagnosis, Edit,
Delete data. Reference Picture: The Right side of the screen contains all relevant images with patient details related to a
particular Diagnosis.
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STATISTICS
SECTION
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When “STATISTICS” button is clicked, the following screen appears. The main aim of the functionality is to avail statistical
information based on different search criteria like
a.
Between two dates
b.
Between two age groups
c.
Based on Diagnosis
d.
Based on Report Data.
Suppose there are 100 patients available and if the User wants to compare percentages of Patients of different diagnosis, it can
be done as below.
There are four types of Charts available and it can be printed also. In the above chart,
C1 , C2 , C3 ,C4, C5, C6 … are representing different types of diagnosis.
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USER
MANAGEMENT
SECTION
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When “User Management “button is pressed, the following screen appears
10.1
Personalized username and password can be given to the user to log-in to the software with different rights. New Users can be
created using the following screen. The created users list will appear in the Login Screen.
“Edit “: This option is used to edit user profile.
Create User
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10.2
User Access
When User Access button is pressed, the following screen appears.
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Select the User and press the Tab button. All
options will appear. Tick the options that need
to be enabled. Tick the capabilities you want to
give to the particular users.
Press “OK” to save the changes and “Cancel”
to close the screen.
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PARAMETER
SECTION
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When “Parameter” button is pressed, the following screen appears
11.1 Com Port Setting
This option is used to choose the Serial port no when the footswitch is connected to the computer through Serial Adaptor or
USB to Serial Adaptor.
Normally the value is 1. When USB to Serial Adaptor is used, go to Device manager, check the COM Port no allocated and
choose the same from the list
11.2
Header Setting
Report Header Option:
MS word:
Select MS word and click on “Header Setting” button, a WordPad like screen will appear where the user can create the
Header details for the Reports.
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MS Paint:
will appear where the user can create the Header details for the Reports for creating Report Header .
If MS word not available in Computer then choose MS paint click on “Header Setting” button, a Paint like screen
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11.2.b Header Saving: P
ress this button after any change in header by MS word or MS paint.
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PATIENT
DATA
MANAGEMENT
SECTION
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When “PATIENT DATA MANAGEMENT” option is selected, the following screen appears.
This screen helps in performing various activities related to Patient Data. Each activity is discussed in detail below.
12.1 Patient Search and Patient Data
12.2 CD- Writing
Patient Search can be done based on Name, Reg no, Start Date, End Date.
Click “Search” button to execute the option to fill the grid.
Click “All “ button to retrieve all patient’s list.
When a patient is selected form the Grid, all relevant details and images associated with that patient is displayed in
Patient Data Section.
12.3 Delete
12.4 Multiple Delete
This button is clicked to write a CD of the selected patient
Delete button is used to Delete a particular patient’s record.
By clicking this option, all patients’ data from the Grid will be deleted completed.
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12.5 Insert Picture
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12.6 Migrate
12.7 Multiple Migrate
12.8 Backup Database
This option is used to insert a new picture from any other location.
This option is used to migrate a particular patient’s data to the location specified in
the Parameter Screen
This option is used to migrate data of all patients displayed on the grid.
This option is used to take backup of entire data of the software.
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13. Labeling Format for Traceability
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13.1 Explanation of Symbol:
Warning: All serious accidents concerning the medical device supplied by us must be reported to the manufacturer and competent
authority of the member state where your registered office is located.
This manual contains information, which may not be copied or duplicated, in full or in part, without the explicit approval of Divine Meditech Pvt Ltd India. We reserve
the right to make any change in the user manual, which may affect instructions in this manual, without giving prior notice. The user of this software shall be solely
responsible for any kind of malfunction to the software as a result of improper use by anyone other than us or a technician duly authorized by the manufacturer to do
so. This operator manual provides directions for using COLpro222DX-OZview Colposcopy Software. Read all instructions prior to use. Failure to follow instructions
could lead to malfunction of the software. The software is intended to be used by qualified Gynecologist with expertise in colposcopy, forensic interpretations, and
analysis. They are entirely responsible for any analysis or reporting using this software.
Manufacturer
Date of manufacture
Authorized representative
in the European
Medical device
Community
Medical Device Compliant with Regulation (EU 2017/745)
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