Intraskandigi Manual

Company Confidential of 62 All information contained in this document and accompanying documents is confidential and is the property of SKANRAY TECHNOLOGIES and cannot be divulged without the prior written consent from an authorized representative of SKANRAY TECHNOLOGIES. If this document was not intended for you please inform the company at [email protected].

Document#UMN-000089-0-20

Document Revision B

Publication Language Document Number:

ENGLISH UMN-000089-0-20

INTRA ORAL DIGITAL X-RAY SYSTEM

USER MANUAL Revision B

TABLE OF CONTENT

INTRODUCTION .......................................................................................... 5

1. INDICATION FOR USE ................................................................... 6

2. CONTRAINDICATIONS ................................................................... 6

3. SAFETY REQUIREMENTS ............................................................. 6

3.1. GENERAL SAFETY TIPS ......................................................................... 6 3.2. SAFETY SYMBOLS ................................................................................. 7 3.3. IMPORTANT INFORMATION.................................................................... 8 3.4. COMPLIANCE TO STANDARDS ............................................................... 8 3.5. WARNING AND CAUTION STATEMENTS ................................................ 9

4. PRE-INSTALLATION INFORMATION AND RECOMMENDATIONS .............................................................................. 12

4.1. PURPOSE OF THE MANUAL ................................................................... 12 4.2. UNPACKING THE UNIT ........................................................................ 12 4.3. PHYSICAL DESCRIPTION OF THE COMPONENT ..................................... 13 4.4. HARDWARE SETUP AND CONNECTIONS .............................................. 15 4.5. COMPUTER REQUIREMENTS ................................................................ 16 4.6. INSTALLATION .................................................................................... 16 4.7. SITE SELECTION .................................................................................. 17 4.8. NETWORK INSTALLATION ................................................................... 17

5. SYSTEM OPERATING INSTRUCTIONS .................................... 17

5.1. SOFTWARE REQUIREMENTS: ............................................................... 17 5.2. HOW TO LOGIN INTO THE SOFTWARE? ................................................ 18 5.3. MENU OPTIONS ................................................................................... 20 5.3.1 TOP ICON BAR .................................................................................................................... 20 5.3.2 QUICK CAPTURE MODE ................................................................................................... 21 5.3.3 DETAILED CAPTURE MODE ............................................................................................. 23

5.4. IMAGE DISPLAY SECTION ................................................................... 39 5.3.4 Pan ........................................................................................................................................ 39 5.3.5 CLOSE .................................................................................................................................. 40 5.3.6 SET UP TOOL BAR .............................................................................................................. 40 5.3.7 SEARCH ................................................................................................................................ 46

6. PERIODIC DATA BACK UP .......................................................... 48

7. MAINTENANCE PROCEDURES .................................................. 48

7.1. CLEANING THE DAS SYSTEM ............................................................. 49


7.2. CLEANING THE SENSORS ..................................................................... 49

8. WARRANTY STATEMENT ............................................................ 49

9. GLOSSARY ....................................................................................... 50

9.1. ABBREVIATIONS AND EXPLANATIONS OF SYMBOLS ........................... 50

10. TROUBLE SHOOTING. .................................................................. 51

10.1. MY SQL ERRORS .................................................................................. 51 10.2. PROBLEM WITH DAS ............................................................................ 51 10.3. PROBLEM WITH THE SENSOR .............................................................. 52

11. APPENDIX ....................................................................................... 53

11.1. APPENDIX A: CALIBRATION .................................................................. 53 11.2. APPENDIX B: TECHNICAL SPECIFICATION ............................................. 57 11.3. APPENDIX C: IF YOU NEED ASSISTANCE ................................................ 61


INTRODUCTION

The IntraSkanDigi designed by Skanray Technologies is an innovative product to completely replace traditional X-ray film based intra oral system and film processor. This system offers following benefits:

v Diagnostic quality images – every time. v Lowers the cost of dental imaging by eliminating the

need for a costly film, chemistry and film processor.

v Saves critical time using advanced processing and display systems. Image capture and display takes less than 5 seconds. v IntraSkanDigi is DICOM compliant.

v IntraSkanDigi is intra-net enabled with multi viewing

capability. Technical Support

For technical support please call the local Skanray dealer. To directly call our customer support, please refer to Section 11.3 (Appendix C).

Supplies and Replacement parts To order supplies or replacement parts for IntraSkanDigi, contact your local Skanray dealer.


1. Indication for use

The IntraSkanDigi is intended for the use as a digital dental radiography using X-ray for radiographic diagnostic intra-oral exposure. System also provides capturing, viewing and processing of the digital X-ray images. The system includes Digital X-ray sensor, Data Acquisition System, communication electronics, software, and various peripheral accessories. 2. Contraindications

There are no contraindications for use. 3. Safety Requirements

Read this section carefully. It contains important safety related instructions.

3.1. General Safety Tips

ELECTRICAL SAFETY

• Always switch off the unit and remove the mains plug when cleaning and disinfecting the unit.

• Do not attempt to open covers or repair the unit yourself or using

non certified service personnel.

INSTALLATION AND SERVICE

• Ensure that the x-ray unit is assembled and installed by qualified service personnel. Consult the factory or Dealer for installation of the unit.

Take the services of qualified personnel when relocating the unit.

CAUTION


3.2. Safety Symbols

The following safety related symbols are found on the equipment. Symbol

symbol name Description

Caution symbol

This symbol indicates the user to be cautious and refer to the user manual for safe operating instructions.

Protective Earth

Mains Earth is required for continued protection against shock hazards.

High Voltage

Dangerous voltages present.

Caution: X-Ray

X-Ray Source Assembly / Tube Head capable of generating x-rays.

Small Focal Spot

Small Focal Spot

WEEE Symbol

Follow proper procedures for disposing this equipment. Cannot be disposed as general waste


3.3. Important Information

It is important that all the personnel who will operate this system read and understand this manual before operating the device. All personnel should follow all warnings and cautions as outlined below, for their safety, safety of the patient and safety of others around them.

3.4. Compliance to Standards

This product is designed and manufactured to meet the following Standards and Regulations:

Standards Title

UL 60601-1 Medical Electrical Equipment, Part1: General Requirements for safety

21CFR Chapter1 Subchapter J Performance Standards for Light-Emitting Products

MDD93/42/ECC European Medical Device Directive (CE Mark)

ISO 13485 Medical Devices– Quality management systems

ISO 14971 Risk Analysis


3.5. Warning and Caution Statements

In this manual, the following definitions apply for all WARNINGS and CAUTION statements. Warnings: Any operation, procedure or practice, which , if not strictly observed, may result in injury or long term health hazards to personnel or the patient. WARNINGS

Should be used by only trained professionals This device should be used by dentists and dental professionals only. Use of this device in procedures other than those described in this manual may result in injury.

Do not open the device to service it. None of the internal parts are user serviceable. If there is a internal problem, call the representative Skanray dealer nearest to you.

Use only grounded electrical connections. Connect the device to a PC connected to a grounded electrical outlet between 100-240 V ac, 50-60 Hz

Sensor should be covered by plastic sleeve. Sensor should not be placed inside the mouth directly. It will have risk of

chemical hazard, contamination, etc to the patient. A plastic sleeve should be used to cover the sensor properly.

Do not reuse the plastic sleeve. The plastic sleeve should be used only once. Once used within the oral cavity, the plastic sleeve becomes bio-contaminated and should NEVER be reused.


User is instructed to insert sensor smoothly into patient’s mouth. Care should be taken while placing the sensor inside the patient’s mouth. Sensor should be placed in such a manner that it doesn’t cause any discomfort or injury to the patient.

Place the sensor in the holder provided with the equipment To avoid damage to the sensor it is advised to cover the sensor with a plastic cover and place it on the holder provided when not in use.

Users are instructed to use CE marked PC

Use only UL OR CE marked PC to avoid electric leakage

Users are instructed to verify the system date Users are instructed to check the system date. The system date (computer date) and the current date should be same. Any anomaly will affect the study date of the patient data.

Calibration procedure should be done periodically. Sensor is calibrated by service engineer at the time of installation. However, user is advised to run calibration once in 90 days to ensure the image quality.

Earthing of the electric point should be checked Check the earthing of the electric point to which the PC is connected. If earthing is not proper then there is a chance of either user or the patient getting an electric shock.

Check for the live part exposed. The system should be thoroughly checked for any electrical/electronic part or the wire intended to be concealed, being exposed. If any part is exposed


or the casing is not proper, it can damage the system or cause injury to the patient or user.

Caution Statements

Do not place device on or next to heat source such as oven or water heater, Or radiation sources such as MRI or CT scanner.

Do not position the device in a dusty environment. Excessive dust levels can result in additional service, beyond normal service intervals.

Do not autoclave the sensors.

Do not scratch the sensor.


4. Pre-installation information and recommendations

4.1. Purpose of the manual

The instructions contained in this manual should be carefully followed for safe, trouble free and effective utilization of the equipment . This manual provides the essential information for the installation, operation and routine care of the device.

4.2. Unpacking the Unit

The IntraSkanDigi system is shipped in a box. Completely unpack the box and store it in a safe, dry location. You may need to repack the unit for shipping if you ever encounter a maintenance outage or while relocating your office. Check whether the contents of the box are according to figures given in 4.2.1-4.2.6. Detailed description of each component is given in section 4.3.

Figure 4.2.1 Figure 4.2.2 DAS Sensor

Figure 4.2.3 Figure 4.2.4 Power Chord User Manual


If any items are damaged or missing, contact your dealer immediately.

Figure 4.2.5 Figure 4.2.6 USB Type AB CD

4.3. Physical Description of the Component

Ø USB Type A B Cable

Type A-B USB cable is as shown in figure 4.3.1 This type of USB consists of two types of plugs Type A and Type B.

Figure 4.3.1

Type A Plug: These are flat form, commonly used at the end of the cable that plugs into computers USB hub or USB port. Type B Plug: These are square form, commonly used at the end of the cable that plugs into USB peripheral or sensors. Type A and Type B plugs are shown in figure 4.3.2

Figure 4.3.2


Ø DAS(Data Acquisition System) DAS (Part No: 142-000001-0) is shown in figure 4.3.3. This device connects the sensor to the PC and acquires data from the sensor and sends to PC for display.

Figure 4.3.3

Ø Sensor:

The image sensor (Part No: 134-000002-0) is as shown in figure 4.3.4

is a CCD image sensor ideal for intra-oral X-ray imaging in

Dental diagnosis. This has 500x1000 Pixels each of which is 20x20 micro meter resolution. The fiber optic plate used as input window is as thin as 1.5 mm but highly resistant to X-ray irradiation, making it very reliable even over a long term operation. This is adaptable to both AC and DC X-ray sources.

Figure 4.3.4


4.4. Hardware Setup and Connections

NOTE: Before you start the hardware setup, ensure that you have an acceptable computer as outlined in Section 4.5. The computer must have an USB port available. Step 1: Pick a location using the guidelines from Section 4.7 Step 2: Set up the computer and monitor as per the manufacturer’s recommendations. Step 3: The Type B plug of USB should be plugged in to the rear panel of the DAS and Type A plug should be plugged into the USB port of the PC. Step 4: Sensor should be connected to the front panel of DSA. The connection is shown schematically in Figure 4.4.1. & 4.4.2 Step 5: Connect the computer to the network if desired. Step 6: Turn the power ON of the computer.

Figure 4.4.1

Figure 4.4.2


CUSTOMER SUPPLIED COMPONENTS Ø Computer System as described in section 4.5 Ø Monitor for viewing

4.5. Computer Requirements

Minimum Computer requirements Recommended

CPU Speed 800 MHz Pentium 4 2.4GHz

Operating System Microsoft XP SP2 Microsoft XP SP2

RAM 512 MB 2 GB

Hard Drive 80 GB 200 GB

USB port USB 2.0 USB 2.0

UPS 500 VA 800VA

Monitor 15 inch S-VGA 17 inch S-VGA

Video Display Adapter 4 MB RAM, 800 x 600 display, true color

8 MB RAM, 1024 x 768 display, true color

Keyboard, Mouse Standard Standard

Backup Device (CD, DVD, Thumbnail, HARD DISK etc.)

Highly Recommended Highly Recommended

4.6. Installation

This device is designed to be installed only by authorized professional/(s) by Skanray.


4.7. Site Selection

The IntraSkanDigi can be installed almost anywhere in the dental office. The site should have:

Ø Access to standard grounded electric outlet. Ø Enough room to allow the operator to mount the sensors and use the computer

effectively.

4.8. Network Installation

Refer to your network professional for network installation. 5. System Operating Instructions

5.1. Software Requirements:

• Microsoft operating system (Windows-XP)

• MYSQL version 4.0.23

• JRE (Java Runtime Environment) version 1.5.0.08 or above version

• Nero (Nero 5 is recommended)


5.2. How to Login into the Software?

As soon as the installation is successfully completed an icon (DENTAL X-RAY) will be created on the desktop (figure 5.2.1). Double click on the icon. When User double clicks on the icon, a Login window is displayed as shown in the figure 5.2.2

Figure: 5.2.1

Figure 5.2.2

Initially the user is provided with the Administrator User Name and Password.

Ø Enter the valid User Name and Password.

Ø Click the Login button.

Ø It will login to the Application.

Ø If you click the Reset button, it will clear the username and password fields.

Ø If user wants software to remember the user name, user should click on the

Remember username check box, so that whenever user opens the software

thereafter, the user name will be present in the field hence no need to reenter.


Ø When user enters the invalid

User Name or invalid

Password, a popup message

window will appear as shown

in the figure: 5.2.3

Ø After entering the correct

username and password the

main window will appear as

shown in figure 5.2.4

Figure 5.2.3

Figure: 5.2.4


5.3. Menu Options

There are mainly three different components in IntraSkanDigi’s main window as shown in Figure 5.3.1 The three main components are

1. Top Icon Bar 2. Image Display section 3. Tool section

Each of these components are explained in detail in the following sections.

Figure 5.3.1

5.3.1 TOP ICON BAR There are 4 icons in the left hand top corner.

Ø REGISTER

Ø IMAGE CAPTURE

Ø SETUP TOOLBAR

Ø SEARCH


5.3.2 QUICK CAPTURE MODE –Without Patient Registration

Ø Click on capture button , If no previously registered patient is available the capture button will automatically forward you to a patient registration window as shown in figure 5.3.2.1.

Ø The mandatory fields are PATIENT

ID, PATIENT NAME and GENDER.

Ø Click on SAVE to save the patient

details. After saving, a tooth image display window will be displayed as shown in figure 5.3.2.2

Ø Select the tooth of which the image

is to be captured. Ø Click on CAPTURE IMAGE, a

message window with message “DEVICE READY-Waiting for X-ray” will be displayed as shown in figure 5.3.2.3

Ø While DEVICE READY-Waiting message is displaying, give the X-ray exposure and image capture will happen automatically.

Ø Once X-ray exposure is given the captured image will be loaded on to the Display panel for review.

Ø Image capture process will continue

until the CANCEL button is clicked

Figure 5.3.2.1

Figure 5.3.2.2


or TIME OUT occurs.

Ø The image displayed in the image display window will be the last captured image.

Ø To capture a new series or

new patient Again Click on CAPTURE, a window as shown in figure 5.3.2.4 will be displayed.

Ø A message “CONTINUE WITH “CURRENT PATIENT OR NEW PATIENT” will be displayed.

Ø If the user wants to capture the

image of same tooth, click on “CURRENT SERIES” and continue capturing image.

Ø If the user wants to capture the

image of different tooth then click on “NEW SERIES”. Tooth image display window (Figure 5.3.2.2) will be displayed.

Ø Select the tooth image which

has to be captured and continue capturing.

Ø If user wishes to capture the

image for a new patient then click on “NEW PATIENT” and follow the capturing procedure mentioned above.

Figure 5.3.2.3

Figure 5.3.2.4


5.3.3 DETAILED CAPTURE MODE Here how to go for step by step procedure of registering a patient and capturing the image is elaborated in detail.

5.3.3.1 REGISTER To REGISTER new patient:

Ø When you click on REGISTER icon (as in figure 5.3.3.1) A window will be displayed.(as in figure 5.3.2.1)

Ø Enter the mandatory fields, PATIENT ID,

PATIENT NAME and GENDER. Ø In this window other patient details such as

address, phone number, date of birth etc can also be entered, though they are not mandatory.

Ø There is another tab button called ‘optional’

available for entering other optional patient details such as patient’s profession, height/weight, education qualification, emergency contact etc.

Ø After entering all the necessary details, click on

SAVE button to proceed.

Ø Tooth display image window will be displayed, (as in Figure 5.3.2.2) select the tooth image which has to be captured and click on CAPTURE IMAGE button and the image will be captured.

Figure 5.3.3.1


5.3.3.2 IMAGE CAPTURE

Ø By clicking the CAPTURE icon(as in Figure: 5.3.3.2), the screen shown in figure 5.3.2.4 will appear.

Ø The window displayed will have three options,

“NEW PATIENT”, “NEW SERIES” and “CURRENT SERIES”.

Ø Clicking on current series will capture the image of

the tooth and load it to the current series.

Ø If user wants to capture the images of a different tooth then click on “NEW SERIES”.

Ø The tooth display image will be displayed. Ø Select the desired tooth and click on CAPTURE

IMAGE.

Ø These images will be loaded to the NEW SERIES.

Ø If user wants to capture image of the new patient then click on “NEW PATIENT”.

Ø Clicking on NEW PATIENT will prompt user to

follow the registration step and then capture the image.

Ø Now the image displayed in the image display

section is the last image captured.

Ø There are many buttons in the tool section which can be used for better viewing of the captured image. The different buttons and their functions are as follows,

Figure: 5.3.3.2


5.3.3.3 ZOOM PROCESS

Ø When one clicks on ZOOM PROCESS icon

(as in Figure: 5.3.3.3 ) It will display the list

of sub options such as Zoom Glass and Zoom

Glass2.

Zoom Glass:

Ø Click on ZOOM GLASS icon (as in Figure:

5.3.3.4) to enlarge the portion of the image where mouse pointer points.

Zoom Glass2:

Ø Clicking on ZOOM GLASS2 icon (as in Figure: 5.3.3.5), makes the image equalized and gives better contrast over the selected region.

Figure: 5.3.3.3

Figure: 5.3.3.4

Figure: 5.3.3.5

5.3.3.4 IMAGE PROCESS IMAGE Process icon (as in Figure: 5.3.3.6) when clicked will display the list of sub options such as Image Enhancement and Invert. Enhancement:

Ø When you click on IMAGE ENHANCEMENT icon (as in Figure: 5.3.3.7) it improves the interpretability or perception of information in images for human viewers, or it provides `better' input for other automated image processing techniques.

Ø This allows the areas of lower local contrast to gain a higher contrast without affecting the global

Figure: 5.3.3.6

Figure: 5.3.3.7


contrast.

Invert: Ø clicking the Invert icon (as in Figure: 5.3.3.8)

inverts the grayscale value of the image. (i.e. Black

vs. White)

For example if the grayscale value is ‘0’, click the invert button the value will be changed to ‘255’ (Black vs. White).

Figure: 5.3.3.8

5.3.3.5 IMAGE ROTATION Ø IMAGE ROTATION icon (as in Figure: 5.3.3.9 )

display’s the list of sub options as Horizontal Flip, Vertical Flip, Rotate 90 and Rotate to a chosen angle when clicked.

Horizontal Flip:

Ø HORIZONTAL FLIP icon when clicked (as in

Figure: 5.3.3.10), flips the image horizontally. Vertical Flip:

Ø VERTICAL FLIP icon when clicked (as in Figure:

5.3.3.11), flips the image vertically.

Rotate 90:

Ø To tilt the image by 90° click on the ROTATE

90° icon (as in Figure 5.3.3.12).

Figure: 5.3.3.9

Figure: 5.3.3.10

Figure: 5.3.3.11

Figure: 5.3.3.12


Rotate Angle:

Ø When you click the ROTATE ANGLE icon(as

in Figure 5.3.3.13) , a popup window opens

with the message “Please Enter the Angle” as

shown in figure 5.3.3.14

Ø One needs to enter the desired angle and click

the OK button then the image will be

rotated/titled by the Corresponding angle.

Figure: 5.3.3.13

Figure 5.3.3.14

5.3.3.6 MULTIPLE SERIES

Ø MULTIPLE SERIES icon when clicked (as in Figure 5.3.3.15) will display the list of sub options like single panel and multiple panel display.

1*1 Series

Ø When you click on the 1*1 SERIES icon (as in Figure 5.3.3.16) , the image will be displayed in a single panel as shown in figure 5.3.3.17

Figure: 5.3.3.15

Figure: 5.3.3.16


Figure 5.3.3.17 1*4 Series

Ø When you click on the 1*4 SERIES icon (as in

Figure 5.3.3.18), a window is displayed with the

first 4 images in the series in different panels.(as in

Figure 5.3.3.19)

Figure: 5.3.3.18


Figure 5.3.3.19

5.3.3.7 SERIES OPERATION

Ø When you click on the SERIES OPERATION icon

(as in Figure 5.3.3.20) it displays different sub

icons such as Series Minus, Series Plus, Series

First and Series Last. SERIES Minus:

Ø When you click on the SERIES MINUS icon (as in

Figure 5.3.3.21) it will display the image of the

previous series.

Ø If the loaded series is the first series then a warning

message will be displayed (as in figure 5.3.3.22).

Figure: 5.3.3.20

Figure: 5.3.3.21


Ø For example, the current image series is in the 3rd

series, if the user clicks this button, this function

will move the image series from 3rd to the 2nd

series. The 2nd image series will be displayed on

the image viewer display panel. If clicked again 1st

series will be displayed.

SERIES Plus:

Ø When you click on the SERIES PLUS icon (as in

Figure 5.3.3.23) it will load the image in the next

series to the image view display section.

Ø If the loaded series is the last series then a

window will be displayed with warning message

“NO MORE SERIES TO LOAD” (as in figure

5.3.3.24).

Ø You can close the dialog box by clicking the Ok

button.

Ø For example, the current image series is in the 3rd

series, if the user clicks this button, this function

will move the image series from 3rd to the 4th

series. The 4th image series will be displayed on

the image viewer display panel

SERIES First:

Ø When you click the SERIES FIRST icon (as in

Figure 5.3.3.25) it will move the series

immediately to the first series viewing position. If

at all it is in First series it will pop up a dialog box

(as in figure: 5.3.3.22)

Ø You need to click the Ok button to close the dialog

box.

Figure: 5.3.3.22

Figure: 5.3.3.23

Figure: 5.3.3.24

Figure: 5.3.3.25


SERIES Last:

Ø When you click the SERIES LAST icon, it

displays the image from the last series.

Ø If at all the current image displayed is of the last

series, a message will be displayed .(as in figure

5.3.3.27)

Figure: 5.3.3.26

Figure: 5.3.3.27

5.3.3.8 RESET

Ø When you click on the RESET icon (as in Figure 5.3.3.28), it will display the sub options such as Reset W/L, Reset Image and Line Reset.

RESET W/L:

Ø To understand the RESET W/L functionality lets

apply the contrast by pressing the right mouse

button and dragging on the image from right to

left or vice versa or from top to bottom or bottom

to top, then the contrast will be applied.

Ø Now when you click the RESET WL icon (as in

Figure 5.3.3.29), the original image without the

applied contrast would be displayed.

Figure: 5.3.3.28

Figure: 5.3.3.29


IMAGE RESET:

Ø To understand the IMAGE RESET functionality,

select any of the option vertical flip or horizontal

flip or rotate angle on an image.

Ø Now when you click the IMAGE RESET icon

(as in Figure 5.3.3.30) it will reset the image to

its original position.

LINE RESET:

Ø To understand Line Reset Functionality you need to draw some lines,curves,points on the image (refer section 5.3.3.9 to understand drawing lines,curves,points on the image)

Ø Now when you click on LINE RESET (as in

Figure 5.3.3.31) all lines or points or curved lines on the image would be erased.

Figure: 5.3.3.30

Figure: 5.3.3.31

5.3.3.9 MEASUREMENT

Ø When you click on the MEASUREMENT icon (as

in Figure 5.3.3.32) it displays different sub options

such as LINE, POINT and CURVE measurement.

Figure: 5.3.3.32


LINE MEASUREMENT:

Ø To draw a line on the image and measure it you

need click on the LINE measurement icon (as in

Figure 5.3.3.33), and place the mouse pointer on

the image, and then draw line by pressing and

holding the left mouse button and drag the mouse

till the destination point and release the mouse

button

Ø Once the user releases the mouse button a line will

be drawn on the image along with the

corresponding distance.

POINT MEASUREMENT:

Ø To draw a point on the image and to know its

value, click the POINT measurement icon (as in

Figure 5.3.3.34) and place the mouse pointer on

the image and press the left mouse button.

Ø Then the point will be placed on the image and the

corresponding value is displayed.

CURVE MEASUREMENT:

Ø To draw a curve on the image and get the distance

between the start point and end point of the curve,

click the CURVE icon (as in Figure 5.3.3.35),

place the mouse pointer on the image, press the left

mouse button and drag the mouse in the desired

pattern.

Figure: 5.3.3.33

Figure: 5.3.3.34

Figure: 5.3.3.35


Once you release the mouse button the curve will be drawn on the image with the Curve measurement displayed.

5.3.3.10 REPORT

Ø The Functionality Report is used to generate reports by Doctor and store it.

Ø you need to click on the Report icon (as in Figure

5.3.3.39a) then it display’s a dialog box (as shown in Figure 5.3.3.39b ).one need to select the template based on requirement ,then input the details which is required in the report and that finishes the report, a message window will be displayed with message whether the report is final.

Ø If the report is final then choose YES, which will

not allow the user to edit the report in future. Ø If chosen NO, user can edit the report in future.

(refer section 5.3.7.5 in this document for setting up report templates)

Figure: 5.3.3.39a

Figure: 5.3.3.39b

5.3.3.11 PRINT

Ø The print functionality helps us to store the images. When you click on the PRINT icon (as in Figure 5.3.3.40 ) it displays sub options such as CD, LOCAL HDD,SCREEN SAVE icons.

C D:

Ø When you click on CD icon (as in figure 5.3.3.41) , it will check whether the CD is inserted and software for burning CD is present.

Figure: 5.3.3.40


Ø If both the above checks are satisfied, then the data will be written onto the CD.

Ø If any one is not present, then a error message will

be displayed

v Nero 5 has to be installed for CD write to work.

LOCAL HDD:

Ø When you click on the LOCAL HDD icon(as in

Figure 5.3.3.42) , it will display a Save Location

window .(as in the figure 5.3.3.43)

Ø You need to select the path and file name of the

image and click the save button.

Ø Data will be saved in the selected path.

SCREEN SAVE

Ø When you click the SCREEN SAVE icon (as in

Figure 5.3.3.44) a popup message window will

be displayed (as in the figure 5.3.3.45) the image

screen will be saved in that particular

Patient’s information list.

Figure: 5.3.3.41

Figure: 5.3.3.42

Figure: 5.3.3.43

Figure: 5.3.3.44

Figure 5.3.3.45


5.3.3.12 DELETE

Ø To delete current image that is displayed from the series click on the DELETE icon (as in figure 5.3.3.46).

Ø After clicking a confirmation window

will be displayed .( as in figure 5.3.3.47)

Ø To delete the image click on YES. Again a window will be displayed (as in figure 5.3.3.48)

Ø Clicking on OK button will delete the image

permanently. Ø Clicking on Cancel will not delete the image.

Figure: 5.3.3.46

Figure 5.3.3.47

Figure 5.3.3.48


5.3.3.13 COLOR

Ø Color function is mainly used to select the color

between Gray Scale and Color Model display of

the images.

Ø When you click the COLOR icon(as in figure

5.3.3.49), a Color Model window is displayed.( as

in the figure:5.3.3.50)

Ø Select any one of the Color Model option, for

example select Gray color model radio button as

shown in the figure: 5.3.3.50, click Ok button.

Ø The selected color model will be applied on the

image.

If Cancel button is clicked, the selected color model will not be applied and will close the Color Model window

Figure: 5.3.3.49

Figure: 5.3.3.50


5.3.3.14 HEADER INFORMATION The Header Information option is mainly used to view the header information such as Tag number, Tag Name and Tag value of the dicom image loaded in the image canvas.

Ø When you click on the HEADER icon (as in

Figure 5.3.3.51), it display’s the header

information of the dicom image which is loaded

in the image viewer display window.

Ø A Dicom Tag Information window is displayed

with the tag information (as in the figure:

5.3.3.52)

Figure: 5.3.3.51

Figure: 5.3.3.52


5.4. Image Display Section

The images will be displayed in the IMAGE DISPLAY SELECTION. Figure 5.3.4.1 shows the image display section with a image in it.

Figure: 5.3.4.1

5.3.4 Pan

Ø To understand the Pan functionality Click the

check box in the PAN icon (as in Figure 5.3.5.1 )

Ø Now press and hold left mouse button and move

the mouse pointer in the image display section,

then image also moves according to the movement

of the mouse pointer.

Ø Deselect the Pan then the image will not be moved

by the motion of the mouse pointer.

Figure: 5.3.5.1


5.3.5 CLOSE

Ø The CLOSE icon (as in Figure 5.3.6.1) is

positioned on the top right hand corner of the

screen.

Ø When you click on it, a window is displayed.(

as in figure 5.3.6.2 )

Ø Clicking “Yes" will close the application.

Figure 5.3.6.1

Figure 5.3.6.2

5.3.6 SET UP TOOL BAR

Ø When you click on the icon (as in figure 5.3.7.1) it

will give the option to change the settings. Ø A window will be displayed as shown in Figure:

5.3.7.2

Figure: 5.3.7.1

Figure 5.3.7.2

There are different setups. They are 1) Display Setup 2) Create Database 3) Sensor Parameter 4) Browser Sort Setup 5) Report Template Setup 6) Calibrate 7) User Login Setup


5.3.6.1 DISPLAY SETUP The Display setup provides an option to set various Application parameters and also the parameters which are related with the Look and Feel. Briefly summarizing those options below.

Measurement:

Ø There are two options Single Mode Measurement and Multi Mode

Measurement.

Ø To choose Single Mode Measurement:

o Select the Single Measurement Mode radio button in the Measurement

window.

o Click the Ok button.

Ø To choose Multiple Mode Measurement:

o Select the Multiple Measurement Mode radio button in the Measurement

window.

o Click the Ok button

Ø Close the Measurement Mode window.

Flip Enable:

Ø Here you are provided with two options, one is flip enable and other is flip

disable.

Enable Calibration:

Ø Here you are provided with two options, one is enable Calibration and other disable Calibration.


Thumbnail: Ø Here you are provided with two options, one is Enable Thumbnail and other

Disable Thumbnail. Text Color: Ø Here you are provided with the option to change the Display text color. Measurement Color: Ø Here you are provided with the option to change the distance color, angel color,

polygon color, and square color and point color display. Browse Color: Ø Here you are provided with the option for the user to change the background and

foreground color of patient list in browser. Filter: Ø Here you are provided with three options. MEAN MEDIAN and NO FILTER. SMOOTH TAB: Ø It’s mainly used for setting the image options i.e. smooth and Real Image. Ø When you click the Setup Tools option, a list of sub options will be displayed,

select the SMOOTH option and then click the Smooth tab, a window is displayed.

Ø Select the Smooth radio button in the Smooth window.

Ø Click the Ok button, a message window is popped up with the message “Values

Inserted Successfully”, click the ok button, the message window will be closed.

Ø Close the Smooth window by using the Cancel button.


5.3.6.2 CREATE DATABASE The Create Database Option is mainly used to update the Images into the MYSQL Database. After loading the Images into the Image folder, the User can click this option for Image updating.

Ø When you click the SETUP tool bar icon , a

list of options will be displayed, select the

Create Database option, a window is displayed

shown in the figure: 5.3.7.2.1

Ø Click the Yes button, a progress bar window is

popped up, above the progress bar Total no of

images loading into the database are displayed.

Ø After loading all the images into the database, a

window is popped up with the message

“Database Created Successfully”. Click Ok

button, window will be closed.

Figure: 5.3.7.2.1


5.3.6.3 SENSOR PARAMETER

Ø When you click the Setup tool bar , a list of

options will be displayed, select the SENSOR

PARAMETER option, a window is displayed

shown in the figure: 5.3.7.3.1

Ø There are five parameters to be set. o FILTERING: Two options are provided

here, on and off. If the value is off filtering is disabled, that is filtering is not done before the image is stored as Dicom image. If this is on filtering is enabled. This will filter the image.

o BINNING: The type of binning done

here is a 2X2 binning. In this the image size will be reduced to ¼ the size of the original image. Here four pixels forming a square box is taken, averaged and then considered as a single pixel, this single pixel is then written to a new file having a new dimension.

o WAIT TIME OUT: Time for which the

application waits for X-ray to happen o GAIN: This is gain of the sensor and

ranges from 1-10. o OFFSET: Range is from 0-255.

Ø After entering all the parameters with desired

values click on update.

After clicking on update a window will appear with

message “successfully saved”. Click on OK, window

will be closed.

Figure: 5.3.7.3.1


5.3.6.4 BROWSER SORT SETUP The “Browse Sort Setup” Option is mainly used for sorting the Patient Information list based on Patient Name or by Study Date.

Ø When you click the Setup Tools button, a list

of sub options will be displayed, select the

Browse Sort Setup option and click the

selected option, a window is displayed as

shown in the figure: 5.3.7.4.1 Ø Select the desired option and click OK Ø After clicking OK a window will pop up with

message “UPDATE SUCCESSFUL” Ø Again click on OK to close the window.

Figure: 5.3.7.4.1

5.3.6.5 REPORT TEMPLATE SETUP

Ø When you click the Setup tool bar , a list of

options will be displayed, select the REPORT

TEMPLATE SETUP option, a window is

displayed as shown in the figure: 5.3.7.5.1

Here specify the path where the reports of the patients are to be stored.

Ø Clicking on REPORT DOC SETUP tab will

allow adding, deleting and updating the report.

Ø After path is set up click on OK, a window

with message VALUE STORED

SUCCESSFULLY. Just click on OK that

window will be closed.

Figure: 5.3.7.5.1


5.3.6.6 CALIBRATE Calibration is performed on the system to make sure that the image obtained is free from error due to small flaws in the sensor

Ø When you click the Setup tool bar, a list of

options will be displayed, select the

CALIBRATE option, a window is displayed as

shown in the figure: 5.3.7.6.1 Ø Enter the password and follow the calibration

steps. Ø Please refer the Service Manual for Calibration

procedure or Appendix A in this document.

Figure: 5.3.7.6.1

5.3.7 SEARCH The “Browser” option is mainly used for browsing the image from the patient’s information list.

Ø When you click on the Browser icon (as in

figure: 5.3.8.1), a window is displayed as shown

in the figure: 5.3.8.2

Ø Click the Search button, the list of patient’s

information, will be displayed in the patient’s

information panel, i.e. on the left side of the

Patients Information window as shown in the

figure: 5.3.8.2

Ø User can search for the patient list in different

form

Figure: 5.3.8.1


Ø Enter the patient name and click on search, list

of the patient name entered will be displayed.

Ø Enter patient ID, list corresponding to that

particular ID will be displayed.

Ø Same way there are options like FROM STUDY

DATE, TO STUDY DATE, TODAY ,

YESTERDAY, 7 DAYS and 30 DAYS.

Ø In Update database panel there are two options,

DELETE and REFRESH DATABASE.

Ø Select a data and click on DELETE, it will

display a message “Are You Sure You Want to

Delete the Data?”

Ø Click on Yes the data will be deleted.

Ø REFRESH DATABASE is used when the data

is loaded from the external device.

Ø Only DICOM data is accepted.

Figure: 5.3.8.3


Figure: 5.3.8.2 6. PERIODIC DATA BACK UP

User should do the data backup periodically. However reminder shall be given by the application. User manually has to back-up two folders Images and Report backup from Intraskandigi folder, in user preferred devices (Thumb Drive, CD, Floppy, DVD etc). 7. Maintenance Procedures

The IntraSkanDigi system is designed for many years of trouble free operation. It’s manufactured from the highest quality components to ensure excellent performance. Maintenance from the operator’s end is minimal.


7.1. Cleaning the DAS System

Turn off the IntraSkanDigi before cleaning. Wipe the outside surfaces with the paper towel dampened with a cold sterile solution or household, non-abrasive cleaner. Do not spray or soak the system. Be careful not to allow running or dripping solvents into the DAS. This could cause damage to the components inside. Allow to air dry before plugging in or turning back on.

7.2. Cleaning the Sensors

Sensors should be handled carefully. For best images, ensure no scratches on them and keep them dust-free. Use the following procedure to clean them:

1. Use lint-free, 100% cotton gauze. Gently wipe the cotton gauze over the dry sensor surface. Wipe back and forth and then in circular motion.

2. To clean any remaining stains, dampen gauze in anhydrous (water-free) isopropyl alcohol and wipe them using the same motion as above.

3. Completely dry the surface by wiping with another piece of cotton gauze. Ensure that the sensor is completely dry before use.

8. Warranty Statement

The IntraSkanDigi is a device designed exclusively for use in the dental office environment and this warranty is not applicable to other uses. The device is warranted against the defects arising from faulty materials or workmanship for one (1) year from the date of purchase. Any item returned to our factory, during the warranty period, through an authorized dealer, will be repaired or replaced at our option at no charge, provided that our inspection shall indicate it to have been defective. Dealer labor, shipping and handling charges are not covered by this warranty.


9. Glossary

9.1. Abbreviations and Explanations of Symbols

AC Alternate current DC Direct current Hz Hertz, cycle per second MHz Mega hertz LED Light Emitting Diode kVp Peak voltage in thousands of volts CD-ROM Compact disk- read only CPU Central Processing Unit RAM Random Access Memory MB Mega Byte GB Giga Byte USB Universal Serial Bus HDD Hard Disk Drive


10. Trouble Shooting.

In the event you experience a problem with the INTRA SKAN digi, Refer to the troubleshooting tips below.

10.1. My SQL errors

Ø One may get errors when MySQL database is

not responding or not started in this scenario

the system pop’s up the error message (as in

figure 10.1)

Ø Trouble shooting can be carried by following

these steps.

Step 1: Restart the application

If the problem still persists continue with step 2

Step 2:Restart the System


Step 3: go to start>control panel >Administrative

tools>Services

check whether mysql service is stopped ,if so

try starting it and then proceed with the

application.

Figure 10.1

10.2. Problem with DAS

Ø One may get errors when DAS is not

connected or not properly connected in this

scenario the system pop’s up the error message


(as in figure 10.2). it also pops’ up a message

telling what to do as in figure 10.3


these steps.

Step 1: Restart the application


Step 2:close the application, Connect the DAS again

and start the application


Step 3: Restart the System and then start the

application

Figure 10.2

Figure 10.3

10.3. Problem with the SENSOR

Ø If SENSOR is not connected properly, then the

image viewer display panel will display white

grainy plain image as shown in figure10.4).


these steps.

Step 1: Close the application

Step 2:check the Sensor connection, connect it

Properly and start the application.

Figure 10.4

For any further assistance contact our nearest Dealer/Skanray Office. for details refer to

Section 11.3 (Appendix C).


11. Appendix

11.1. Appendix A: Calibration

Calibration is done to minimize the dark and white noise effect of the sensor on the image. Calibration is done:

Ø When the instrument is new Ø When specified time period is elapsed Ø When a specified usage (operating hours) has elapsed

Steps for Calibration

Connect the DAS and sensor to the PC using the guidelines from section 4.4

Ø After connection is done start the application. Ø Place the sensor such that the active region should

face the X-ray source.

Ø Also the sensor should be in the field of view of the X-ray source.

Ø Click on SET UP TOOL BAR a window as shown

in figure 11.1.1.1 will appear.

Figure 11.1.1.1


Ø Select calibrate radio button it will prompt the

password window as shown in figure 11.1.1.2

Ø Enter the service password. If the service password entered is wrong it will display a error message is displayed as shown in figure 11.1.1.3

Ø Click on ok and enter the correct password

Ø Now the device is ready and it will display the

message as “DEVICE READY WAITING FOR X-RAY” as shown in figure 11.1.1.4

Ø Now give the X-ray shot. For calibrating

IntraSkanDigi, 32 X-ray shots should be given. Ø The calculations will be performed by the system. Ø White images will be captured first and then Dark

images will be captured. Ø The derived calibration data will be stored in the

application folder. Ø A message will be displayed “CALIBRATION

SUCCESSFULLY COMPLETED”

Figure 11.1.1.2

Figure 11.1.1.3

Figure 11.1.1.4


Verification of Calibration

Ø Now RESTART the application

Ø Place test phantom on the sensor.

Ø Now click on SET UP TOOLBAR select DISPLAY SETUP radio button, click on ENABLE CALIBRATION button and select CORRECTION DISABLED button.(as in Figure 11.1.2.1)

Ø Click on Apply, a success message will be displayed as shown in figure11.1.2.2

Ø Click on Ok. Ø Capture the image.

Ø Now again click on SET UP TOOLBAR, select DISPLAY SETUP radio button, click on ENABLE CALIBRATION button and select CORRECTION ENABLED button(as in Figure 11.1.2.3)

Figure 11.1.2.1

Figure 11.1.2.2

Figure 11.1.2.3


Ø Click on Apply, a success message will be displayed as shown in figure 11.1.2.4

Ø Click on Ok.

Ø Capture the image of the same phantom.

Ø Now analyze the image captured.

Ø The image captured with correction disabled will

have some difference in the pixel values from one end to the other

Ø The image captured with the correction enabled

will have almost same pixel values at both the end. This shows that the calibration process was successful.

Figure 11.1.2.4


11.2. Appendix B: Technical Specification

DAS (DATA ACQUISATION SYSTEM)

Figure 11.2.1


PARAMETER CONDITION SPECIFICATION UNIT

Scanning 1 MHz

Frame readout time 1.62 s

Data Transfer time 1.61 s

Total Transfer time 3.2 s

AD conversion resolution 4095ADU 12 bit

Conversion gain 48.8 e/ADU

Readout noise 7 ADU

Dynamic Range 585

Memory Size 4 MByte

Power Consumption 350max mA

Storage Temperature -20 to +70 °C

Operating Temperature 0 to +50 °C

Operating Humidity No condensation 70% Max

Dimension 32(H)x115(W)x125(D) mm

Weight 200 g


SENSOR

Figure 11.2.2


§ SENSOR DETAILS

Type No Cooling No of total Pixels

No of Active Pixels

Active Area [mm(H) x mm(V)]

S8981-02 Non-cooled 1508 x 1002 1500 x 1000 30 x 20

§ GENERAL RATINGS

Parameter Specification

CCD Structure Full frame transfer

Fill factor 100%

Number of Active Pixels 1500 (H) x 1000 (V)

Pixel Size 20 (H) x 20 (V) µm

Active Area 30 (H) x 20 (V) µm

Vertical Clock Phase 2 phase

Horizontal Clock Phase 2 phase

Output Circuit Emitter follower without resistance

Dimensional Outline 38.7 (H) x 26.3 (V) mm

Reliability 100,000 shots at 60 kVp, 30 m Roentgen

Window Scintillator on 1.5mm FOP

Storage Temperature -20 to +70 °C

Operating Temperature 0 to +40 °C


11.3. Appendix C: If you need Assistance

The IntraSkanDigi is designed to provide years of trouble-free service, and carries a limited warranty. If you need assistance, you can contact the Skanray office nearest to you.

Mysore Skanray Technologies Pvt Ltd., #78 - A & B, Hootagalli Industrial Area, Mysore - 570 018. India. E-Mail: [email protected] Phone: +91 821 241 5559 Fax: +91 821 240 3344 E-Mail: For products: [email protected] For services: [email protected] For contacting the office: [email protected] Overseas Contacts United States: 4 Lakeview, Irvine, CA92604, USA. Phone: 1-401-854-6174 E-Mail: [email protected]

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