iOX3 User Guide - autoklawautoklaw.com/produkty/rtg-i-obrazowanie/obrazowanie-2/... · 2013. 2....

X-ray Sensor System Model iOX3 UltiMax

Dental Imaging System

User Guide

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iOX3 ULTIMAX

Thank you for purchasing this state-of-art iOX3 UltiMax.

This system is designed to meet the highest quality standards, keeping the dentist’s expectations in mind. This iOX3 UltiMax third-generation X-ray sensor system follows in the footsteps of the highly successful original iOX system, thereby incorporating all the newest technology and years of experience Fimet Oy has in the digital X-ray field. We hope you will find working with this system both enjoyable and effective!

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IMPORTANT!

- This symbol is used for the important operating instructions

- Read this guide before using the iOX3 UltiMax X-ray Sensor System.

- Install the iOX3 UltiMax software on your computer by carefully following the instructions in the Installation Part of this guide. You can start using the system when the installation process has been completed.

- Never remove or damage iOX3 UltiMax sensor identification serial number label from the USB wire of the product. That will terminate the product warranty because of the product cannot be anymore identified.

iOX3 ULTIMAX SOFTWARE LICENSE AGREEMENT

You should carefully read the following terms and conditions before using this software. Use of this software indicates that you accept this license agreement and the warranty implied herein.

Registered Version

One registered copy of software may either be used by a single person who is using the software on one or more computers, or it can be installed to a single workstation used non-simultaneously by multiple users, but not both.

Disclaimer of Warranty

THIS SOFTWARE AND THE ACCOMPANYING FILES ARE SOLD "AS IS" AND WITHOUT WARRANTIES AS TO PERFORMANCE OR MERCHANTABILITY OR ANY OTHER WARRANTIES WHETHER EXPRESSED OR IMPLIED. Because of the various hardware and software environments in which the software may be used in, NO WARRANTY OF SUITABILITY FOR A PARTICULAR PURPOSE IS OFFERED.

Good data processing procedure dictates that any program is thoroughly tested with non-critical data before it is relied upon. The user must assume the entire risk of using the program. ANY LIABILITY OF THE SELLER WILL BE LIMITED EXCLUSIVELY TO PRODUCT REPLACEMENT OR REFUND OF PURCHASE PRICE.

If the hardware is used with third-party software, please refer to the license agreement of the software in question.

Manufacturer:

Fimet Oy, Finland

Fimet Oy reserves the right to change this document.

Copyright ©2010 Fimet Oy, ver 1.0

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TABLE OF CONTENTS

1. IMPORTANT SAFETY INFORMATION ................................................................................ 6 2. SYSTEM OVERVIEW ................................................................................................................... 7

2.1. Intended Use ............................................................................................................... 8 2.2. Expected Lifetime ................................................................................................................. 8 2.3. Minimum Requirements ........................................................................................................ 8 2.4. Recommended System ........................................................................................................ 8

2.5. Cautious Use of the Sensor ......................................................................................... 9 3. SOFTWARE INSTALLATION ........................................................................................................ 9

3.1. Installation Menu ................................................................................................................ 10 3.2. Welcome ............................................................................................................................ 11 3.3. License Agreement ............................................................................................................. 11 3.4. Registration ........................................................................................................................ 11 3.5. Local Installation (Single Computer Mode) ......................................................................... 12 3.6. Multi User Installation ......................................................................................................... 14 3.7. Program Options & Destination Folders .............................................................................. 14 3.8. Final Confirmation .............................................................................................................. 15 3.9. Installation .......................................................................................................................... 16 3.10. Finish .................................................................................................................................. 16

4. THINGS TO READ BEFORE USE .............................................................................................. 16 4.1. Installing the Calibration File ............................................................................................... 16 4.2. Configuring the Sensor ....................................................................................................... 16 4.3. Testing the System before Use ........................................................................................... 18 4.4. The Constancy of Image Quality ......................................................................................... 18 4.5. Obtaining Optimum Image Quality ...................................................................................... 18

4.6. Cleaning and Disinfecting .......................................................................................... 19 4.7. Electromagnetic Compatibility............................................................................................. 19 4.8. Switching the Sensor Size .................................................................................................. 19

5. THE ULTIMAX SOFTWARE ........................................................................................................ 20 5.1. UltiMax Data ....................................................................................................................... 20 5.2. Software Interface and Features ......................................................................................... 23 5.3. Buttons ............................................................................................................................... 23

5.3.1. X-ray Acquisition ........................................................................................................... 24 5.3.2. Scale ............................................................................................................................. 25 5.3.3. Grid ............................................................................................................................... 25 5.3.4. Annotations ................................................................................................................... 25 5.3.5. Desktop ......................................................................................................................... 26 5.3.6. Auto Contrast ................................................................................................................ 27 5.3.7. Rotate ........................................................................................................................... 28 5.3.8. Invert ............................................................................................................................. 28 5.3.9. Print .............................................................................................................................. 28 5.3.10. Save Image ................................................................................................................... 29 5.3.11. Exit ................................................................................................................................ 29

5.4. Software Menu Bar and Other Features ............................................................................. 30 5.4.1. File Menu ...................................................................................................................... 30 5.4.2. Edit Menu ...................................................................................................................... 30 5.4.3. Display Menu ................................................................................................................ 30 5.4.4. Options Menu................................................................................................................ 31 5.4.5. Language Menu ............................................................................................................ 31

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5.4.6. Help Menu .................................................................................................................... 31 5.4.7. General Settings ........................................................................................................... 32 5.4.8. Brightness and Contrast Combo ................................................................................... 33 5.4.9. Calibration Table ........................................................................................................... 33 5.4.10. Customize Button Toolbar ............................................................................................. 33 5.4.11. Export Picture ............................................................................................................... 34 5.4.12. Export Picture Directory ................................................................................................ 34 5.4.13. Image Library ................................................................................................................ 36 5.4.14. Import Picture................................................................................................................ 38 5.4.15. Import Picture Directory ................................................................................................ 39 5.4.16. Info Bar ......................................................................................................................... 39 5.4.17. Macros .......................................................................................................................... 40 5.4.18. Regional Settings .......................................................................................................... 40 5.4.19. Registration ................................................................................................................... 41 5.4.20. Resample Image ........................................................................................................... 41

6. IOX IMAGE VIEWER DATABASE REPAIR AND CONVERSION ................................................ 42 6.1. Repair and prepare iOX Image Viewer database ................................................................ 42 6.2. Convert iOX Image Viewer database to UltiMax ................................................................. 42

7. HOLDER SET (OPTIONAL ACCESSORY) ................................................................................. 44 7.1. Contents ............................................................................................................................. 45 7.2. Wall Holder for Sensors ...................................................................................................... 45 7.3. Disposable Hygiene Bags ................................................................................................... 46 7.4. Cord Clips........................................................................................................................... 46 7.5. Reduction Plate .................................................................................................................. 46 7.6. Anterior Area Images .......................................................................................................... 47

7.6.1. Upper Anterior Area Images .......................................................................................... 47 7.6.2. Lower Anterior Area Images .......................................................................................... 48

7.7. Horizontal Images ............................................................................................................... 48 7.7.1. Posterior Lower Left Area Horizontal Image .................................................................. 48

7.8. Vertical Images ................................................................................................................... 49 7.8.1. Posterior Lower Right Area Vertical Image .................................................................... 49 7.8.2. Posterior Upper Left Area Vertical Image ...................................................................... 50

7.9. Horizontal Bite Wing Images .............................................................................................. 50 7.10. Vertical Bite Wing Images ................................................................................................... 51

8. GENERAL SPECIFICATIONS ..................................................................................................... 52 9. TROUBLESHOOTING ................................................................................................................ 53

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DEFINITIONS

- iOX3 UltiMax System is the complete system including sensor(s),

software and computer as a complete functional product. Additionally the

complete system may have a sensor holder set. Later in this User Guide,

iOX3 UltiMax System is mentioned as system.

- iOX3 UltiMax Equipment is including a sensor(s) and software as a

normal factory shipment. The equipment is not a functional product and it

needs an additional computer to work. Later in this User Guide, iOX3

UltiMax Equipment is mentioned as equipment.

- iOX3 UltiMax Hardware is the complete system excluding the software.

Later in this User Guide, iOX3 UltiMax Hardware is mentioned as

hardware.

- iOX3 UltiMax Sensor is the CMOS sensor only. Later in this User Guide,

iOX3 UltiMax Sensor is mentioned as sensor.

- iOX3 UltiMax Software is a user interface software to use the system.

Later in this User Guide, iOX3 UltiMax Software is mentioned as

software.

1. IMPORTANT SAFETY INFORMATION

Read this chapter before using the System.

The system has been designed to meet the EU medical directive

requirements and the stringent medical standards. It has effective electrical

insulation to protect the patient and user from electric shocks. The sensor

meets the IEC 60601-1 (ed.3) safety standard for medical equipment.

The system is intended to be used at a dental clinic. Only trained and

qualified professionals are authorized to take X-ray images. The user may

need to have a permission/license to use X-ray generator devices.

The system is suitable for all patients where physically applicable. Pregnant

women should avoid X-rays.

The computer used with the equipment must meet the requirements of EN

60601-1 standard or the computer must be located outside of patient

environment (1.5 meters from the patient and equipment). In case the

system is operated through "USB hub" or equivalent component, same

requirement applies to such a device.

The sensor, cable and the connector must be handled with adequate care

and checked thoroughly before any exposures are taken.

The polyurethane cover (insulant) of the cable is important safety factor and

its condition must be ensured. It is possible, that the sensor cable is bitten by

accident by the patient and the cover is broken. The cable condition must be

checked before any exposures are taken.

The sensor and at least 20 centimeters of the sensor cable must be

disinfected using a 50 % - 50 % alcohol/water solution before each use, by

wiping the sensor and cable with a moist cloth. Do not pull at the sensor

cable. The sensor is not autoclavable.

Using the disposable sensor covers is obligatory. Covers must be checked

for defects before use.

A specific, individual calibration file (supplied with the sensor) has to be used

with the sensor, in order to ensure adequate image quality.

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If third-party software (other than iOX3 UltiMax software) is used with the

hardware, please refer to the guide of the software in question.

To ensure system functionality, connect only the devices specified in this

guide to the system. The manufacturer of the system cannot guarantee

system compatibility with any other systems/devices. Compatibility of the

system with any third-party devices or software is at the user’s own risk.

The printouts from the system are not for diagnoses. The image quality may

be reduced in printing.

The quality of image has to be checked regularly to avoid incorrect

diagnosis. See paragraph 4.4

2. SYSTEM OVERVIEW

First, make sure the package contains all of the following items:

- iOX3 Sensor (iOX3 600 and / or iOX3 900, depending on order)

- USB stick containing iOX3 UltiMax software, iOX3 Sensor Calibration

File (one for each Sensor) and iOX3 User Guide

- USB-Dongle (hardware key) for iOX3 UltiMax

- Hygiene covers (disposable covers for the sensor).

- iOX3 Sensor Holder Set (if ordered)

The system is for taking intra-oral X-ray images.

The full system consists of the following components: Sensor(s) 600 mm2

and / or 900 mm2, Hygiene covers, a software CD, a calibration CD (one for

each individual sensor), a set of sensor holders (optional, must be ordered

separately) a computer (not included in the package) and a printer (not

included in the package).

The sensor(s) is a CMOS sensor (Complementary Metal Oxide

Semiconductor), which detects X-rays. The sensor has an active area of 20

mm x 30 mm (600 mm2) or 36 mm x 26 mm (900 mm2), and it uses 12-bit

data acquisition. This means that it can record 4,096 various shades of gray.

The sensor has 1,580 x 1050 pixels (600 mm2) or 1,896 x 1,368 pixels (900

mm2), which adds up to a total of 1,659,000 pixels and 2,765 pixels/mm2

(600 mm2) or 2,593,728 pixels and 2,881 pixels/mm2 (900 mm2). The

sensor is equipped with a 2.9 meter cable and a connector.

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The sensor is connected to the computer via the computer's USB port

(Universal Serial Bus). The USB port is a high-speed data bus found in all

modern computers.

The software is the user interface for the sensor. It includes powerful image

handling capabilities as well as a UltiMax Data which stores patient records.

Images and patient records are kept on the computer’s hard disk. In the

UltiMax Data, each patient is provided with a patient card that contains

patient data. From UltiMax Data you can use the software to take, view,

handle, and store X-ray images.

If third party software is used, the installation of the system may otherwise

differ from this guide. For installation instructions in this case, please refer to

the manual of the third-party software used.

2.1. Intended Use

The system generates fast and easily intra-oral X-ray images from patient’s

teeth, implants and implant attachments including surrounding areas. One

image, which is of the CMOS detector’s size, can be taken at a time. The

image information can be used to estimate the need of treatment or during

the treatment to check the on-going operation. The images are viewed,

handled and stored with the supplied software or appropriate software

produced by third-party. The product is intended to be used together with a

dental intra oral X-ray machine. The X-ray machine generates X-rays

needed by the system. The X-ray generator may be of type AC or DC.

The system is medical health care equipment. Intended use is only for

dental diagnosis and care. Only a trained professional shall use the system.

This equipment is not a consumer product.

2.2. Expected Lifetime

The lifetime of the sensor is determined by the CMOS sensor maximum total

dose of radiation. The maximum dose over the product life is 20 Gy

corresponding to approximately 50 000 – 200 000 (typical 150 000) dental

X-ray shots. The exact lifetime is impossible to determine, because the

X-ray’s will diminish the picture quality. The average expected lifetime of the

device is six years.

2.3. Minimum Requirements

The minimum system requirements for the computer are:

- Windows XP®, Windows Vista® or Windows 7®

- Intel 1,2 GHz Pentium® processor (or compatible)

- 256 MB RAM

- 1024 x 768 x 16-bit Super VGA (High Color) display

- Hard drive with 1 GB of free space (sufficient for storing approximately

1000 images)

- CD-ROM Drive

- USB 2.0 port

2.4. Recommended System

The recommended system specifications are:

- Windows XP® or Windows Vista® or Windows 7®

- Intel 2 GHz Pentium IV® processor (or compatible) or faster

- minimum of 512 MB RAM

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- 1,280 x 1,024, 24-bit/32-bit color (True Color) display

- Hard drive with 50 GB of free space (sufficient to store approximately

50,000 images)

- CD-ROM or DVD-ROM Drive

- USB 2.0 port

- Tape drive or DVD-Writer for backup

- High resolution A4 size printer

2.5. Cautious Use of the Sensor

The sensor is a sensitive electrical device with advanced CMOS technology.

It should always be handled with extreme care. Never let the sensor fall to

the floor as it may be damaged by the impact.

Be careful not to twist or bend the cable excessively.

Beware of static electricity when the sensor is not connected to the

computer. Do not touch the pins of the sensor connector.

3. SOFTWARE INSTALLATION

The software has been designed to be used with the supplied equipment.

The software is used to receive and store images sent by the sensor(s) and

to display the images on the computer screen. Hard copies of the images

can be made by using any printer supported by the operating system. The

user interface of the software has been designed to be intuitive and

user-friendly.

NOTICE!

Fimet Oy will provide free updates for one year after the software is installed.

After that updates will be charged. Please contact [email protected] for more

information.

mailto:[email protected]

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3.1. Installation Menu

Please note that computer Administrator rights are required to complete the

UltiMax installation.

Insert the software USB memory stick into the computers usb-port.

By default, windows will launch the UltiMax menu. If your computer doesn’t

launch it, you can start it manually by clicking on ‘Start’ and then on ‘Run…’

and then type ‘E:\Menu\Launch.exe’ where E: is the drive associated to the

USB memory stick. The software installation menu will launch:

Click on ‘INSTALL PRODUCTS’

Click on “INSTALL iOX3 Driver”. Wait for few minutes as the drivers are

automatically installed. Then click on “INSTALL ULTIMAX” and UltiMax

installer starts. Note: Depending on your Windows security settings, you

may need to confirm file execution and driver installation during the driver

and UltiMax installation. Also User account control in Windows Vista and

Seven may interfere with the installer. You can disable user account control

when installing the UltiMax.

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3.2. Welcome

After the pre-installation tasks are performed the next window will be shown:

Press next (the green arrow) to continue the installation.

3.3. License Agreement

At this point the license agreement is at hand.

Please read the license agreement carefully, afterwards check ‘I have read,

understood, and accept the license agreement displayed above’ and click

next to continue.

3.4. Registration

During the registration the installer will check your license key. There are a

number of possible scenarios.

For all steps some things are common. If you are using an USB license key,

the installer will detect it and may ask you to disconnect it from the computer:

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If you disconnect your key, the installer will notice this. No user interaction is

required. At certain points the installer will ask you to connect your USB key

again (or click green arrow in case of another key).

Connecting an USB license key will be detected, for parallel keys you need

to click next.

3.5. Local Installation (Single Computer Mode)

When running UltiMax on 1 computer only, the license key must be

connected to this station. The installer will start by installing the license key

drivers.

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The installer will then ask you to connect your key.

As previously explained, USB keys are detected by the installer, once you

connect them, the installer will continue. If no key is found or you don’t have

a key, you will be prompted to select the key’s location:

Here you can select to install UltiMax in demo mode. This way you can try

the product for 30 days. Via this window you can also let the installer retry to

detect the license key.

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3.6. Multi User Installation

When several users use the same iOX3 UltiMax license the registration

should be made by the vendor because the hardware key has to be installed

to a server. If problems occur please ask help: [email protected].

3.7. Program Options & Destination Folders

With UltiMax some options can be installed.

- Sample images (images for the demo patient)

- UltiMax Data (Front-end Database Program or Practice Management

System)

When no options are checked the only destination folder you can set is the

UltiMax Program folder.

If you check ‘Sample images’ or ‘UltiMax Data’ more destination folders can

be set:

- Sample Images location,

- UltiMax Data program location,

- the Patient Database location,

- the Patient Image Library location.

All additional program options can also be installed afterwards.


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If any previous versions of our products were ever installed on the system,

the installer will indicate this:

Note: Previous versions of our product are not detected by the installation

folder but by registry entries.

3.8. Final Confirmation

Once all settings are correct the following confirmation window will be

shown:

Click next to continue with the installation.

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3.9. Installation

The installer will install all selected program components.

No user interaction is required during the installation.

3.10. Finish

When the installation is complete it will be shown:

The installation is now complete, click to finish the setup.

4. THINGS TO READ BEFORE USE

Here are listed some things that user should read before using the system.

Please read this section carefully to prevent misuse.

4.1. Installing the Calibration File

After installing the software the calibration file is automatically copied to the

right place. To calibrate the sensor again please read 4.2 Configuring the

Sensor.

4.2. Configuring the Sensor

Connect the iOX3 sensor to your computer USB port if it is not connected

yet. Start UltiMax by double clicking UltiMax demo patient shortcut on your

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desktop or find it from the Windows Start menu. iOX3 sensors are

preconfigured with default settings and you can start taking images.

If the images are too dark or too light by default, here are instructions how to

change the gain setting. When UltiMax has started press F10 button and

General settings will open. From the left side of the window you will find

button labeled “X-ray Fimet iOX3”. Click it and a new tab will open.

This tab allows you to change the X-ray acquisition screen resolution from

Desktop File drop down menu and from Auto Acquisition Mode you can

choose if the sensor is automatically activated when X-Ray acquisition

button is pressed. To change the sensor configuration click Get Devices

button and then click the button with two gearwheels and the iOX3

interface window will open.

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iOX3 interface provides options to configure and calibrate the sensor. It is

possible to take test shots by clicking Acquire. To configure the sensor,

click Get Devices -button and sensor serial number will appear on the drop

down menu. Click Select and then click Configure -button.

Only thing you may have to change

from the configuration is Gain. All

other settings can be left to defaults.

Experiment with the Gain setting to

find the optimum setting for your

sensor and X-ray source. Usually

Gain is set to 4.0 or 6.0. Click OK

button after if you made changes to

configuration.

If you need to recalibrate the sensor,

just click Calibrate -button from the

Configuration and the program will

give you instructions on screen. Nine

exposures are needed. Make sure

there is nothing in between the

sensor and the X-ray source. If the

sensor is already calibrated you have to delete current calibration file from

UltiMax installation directory. When Configuration or Calibration is done you

can close the iOX3 interface window.

4.3. Testing the System before Use

Before starting to use the system, a system test should be performed. The

sensor should be tested with the X-ray generator without patient. The

minimum exposure time to get fully black image should be determined. That

time should be instructed to be the maximum exposure time for the X-ray

generator to avoid unnecessary radiation to the patients.

4.4. The Constancy of Image Quality

The quality of image has to be checked regularly to avoid incorrect

diagnosis. A test image has to be taken regularly using an applicable device

(IEC 61223-2-7). For instance QUART GmbH manufactures suitable dental

test phantoms.

4.5. Obtaining Optimum Image Quality

Two main factors

influence image

quality. The first is the

display device (e.g.,

the monitor) used for

viewing the images.

The second factor is

proper operation of

the system to achieve

optimum image

quality.

The sensor's

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exposure time is 0.02 - 0.08 seconds with High Frequency (DC) X-ray

generators (60 - 70 kV, 7 mA, DC). With conventional (AC, single pulse)

X-ray generators the exposure time is longer. See the figure below for

details.

The high sensitivity of the sensor is extremely important, as this allows the

patient's radiation dose to be reduced considerably. Because of the high

sensitivity of the sensor, we recommend the following operating procedure

for obtaining optimum image quality with little interference:

1. Wipe the sensor head and at least 20 cm of the sensor cable from the

sensor end using a 50 % - 50 % alcohol/water solution. After applying,

allow 1 minute for the solution to evaporate.

2. Place a hygiene cover over the sensor head. If Salibags are used, the

white side of it must be placed against the active side of the sensor

head.

3. Activate the sensor from your computer by clicking the X-Ray

acquisition button from UltiMax buttons. Wait until the green status text

states “Ready for exposure”.

4. Place the sensor into the patient's mouth.

5. Set X-ray timer and voltage.

6. Place the X-ray tube in the correct position.

7. Expose as usual.

8. The image should appear on your screen in a few seconds. You can

take the next image immediately by simply exposing again. After taking

pictures press exit button. Sensor deactivates automatically. Save the

images you want to store.

9. Image can be chosen from the right side image library and handle it with

the tools wanted.

4.6. Cleaning and Disinfecting

The sensor can be disinfected using a 50 % - 50 % alcohol/water solution.

Wipe the sensor clean with a moist cloth. Do not pull at the sensor cable

when wiping. Do not autoclave the sensor. Always use hygiene covers while

treating patients. The Adapter Box can be cleaned using a mild disinfectant

fluid. Avoid using strong detergents. It is recommended to use, e.g., a 2 - 4

percent Super-Blue detergent solution. Do not put the Adapter Box into an

autoclave. The sensor holders can be disinfected using an autoclave. You

can also use alcohol-based disinfectants for disinfecting the holders.

4.7. Electromagnetic Compatibility

The system meets EN 60601-1-2 (2007) requirement. The system contains

electronic components that may emit electromagnetic radiation.

Electromagnetic radiation is not harmful to humans, but it may affect other

electronic devices.

4.8. Switching the Sensor Size

The iOX3 system has two different sensor sizes available – 600 mm2 and

900 mm2. Both sensor sizes can be connected on the same computer at the

same time. Both sensors cannot be activated at the same time. To change

the sensor, open X-ray acquisition and first press ESC-key to deactivate the

sensor. Then select sensor #1 or #2 from upper left corner. After selection

the selected sensor will be automatically activated.

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Switching sensor size

-procedure may differ

if third-party software

is used. For

instructions, please

refer to the manual of

the third-party

software concerned.

5. THE ULTIMAX SOFTWARE

The sensor is connected to a personal computer using a USB connection.

The user operates the sensor with the software. It includes powerful image

handling capabilities, as well as an UltiMax Data program for storing patient

records. Images and patient records are kept stored on the computer's hard

disk. The program allows viewing, maintaining and storing of images.

Several other software developers have designed programs capable of

connecting to the sensor.

This guide includes instructions for using the software. Other software

products will not be discussed in this guide. For information regarding other

software, please contact your authorized software supplier.

To activate the system, click Start, point to Programs, select Fimet Oy, and

then click UltiMax Data to create a patient or UltiMax Demo Patient to test

your sensor with a demo patient.

5.1. UltiMax Data

UltiMax Data is the practice management software (PMS) that is delivered

with UltiMax Imaging software. UltiMax Data is easy to use and it is already

linked to UltiMax Imaging software, so you just have to do a few changes to

basic preferences and you are ready to start.

This is the default view of UltiMax Data:

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1. Main menu.

2. From left to right:

- UltiMax button, which launches the UltiMax imaging software with

the chosen patient.

- Excel button, which opens Microsoft Excel with current patient

information.

- Calculator

- Exit button.

3. Patient information and Patient images tabs.

4. Doctor selector, Create new patient button, Search patients button,

Database access buttons and exit button.

5. Patient image (if added), Alert window where all very important

information about the patient is shown.

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First change your contact information through the main menu: Options –>

Preferences. On Practice info tab you can input all clinic and doctor

information. At the bottom you see 10 little buttons; these buttons are on

every tab where you can input information.

From these buttons you can control database entries. From left to right these

buttons are: Go to the beginning, Previous, Next, Go to the end, New,

Delete, Modify, Save, Cancel and Refresh. Write your information to name

and address fields and press the Save button. If you need to add another

entry, click the New button.

To add some additional information like doctors who to forward your patients

or referring doctors etc. scroll the tabs in preferences and fill in the

information if needed. Always remember to press Save button after adding

or modifying information. From Backup tab you can set daily backup of the

patient database and change some settings of backup procedure. Notice

that this backup does not cover the losses in case of hard drive failure.

Please use 3rd party software and hardware to back up your database daily.

After you have added or modified the needed information press the Exit

button.

Language settings can be changed from the main menu: Language –> and

choose your own language. If your language is not listed and you want to

use UltiMax in your own language please contact us [email protected]

To create a new patient press New button in the right and start to fill in the

patient information. There are some fields in Patient information tab that

must be filled. UltiMax Data will notify you if something important is missing.

In drop down menus like country or title you can add items by clicking right


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mouse button on the field and selecting Add. When all needed information

of the patient is inserted remember to press Save button in the right.

When patient information is saved and you want to take some images of the

selected patient press UltiMax icon from upper left corner to launch UltiMax

imaging software.

5.2. Software Interface and Features

The software is built of many different desktop panels. At the top you can

see button panel, in the middle is image panel or panels, on the right the

image library and brightness/contrast control. At the bottom you’ll see the

status bar. Sometimes software does not detect your display resolution right

and the panels are not displayed right. You can fix this by selecting

Display->Desktop Panels->Load desktop and choose the right resolution

for your display.

UltiMax interface with two image desktops.

By default the software interface is locked so all UltiMax panels (like button

bar, image panel etc.) are locked to a defined place. To move panels go to

main menu and select Display->Desktop Panels->Lock desktop. Now

you can move panels as you like by dragging and dropping components

from upper left corner where you see two stripes.

Next pages are mostly taken from UltiMax help file. Here you will find

descriptions of buttons and main menu of UltiMax. You will find same text in

UltiMax main menu under Help tab. There this text is indexed and with

search engine.

5.3. Buttons

Here you can read about buttons that are enabled by default in the software.

Some of the buttons like annotations open their own panels. These panels

can be closed by clicking the same button again. Remember to unlock the

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desktop to move these panels if they happen to be located in front of the

image. UltiMax help tells you more about the other buttons and how to

enable them.

From left to right: X-ray acquisition, Scale, Grid, Annotations, Desktops,

Auto contrast, Reload image, Invert, Print, Save image and Exit.

The most important button is X-ray acquisition where you can take X-ray

images. Other image sources can be imported images from your computer

or video capture devices. To import an image choose File-> Import picture

from main menu.

UltiMax has some button shortcuts. Here is a list of those:

- Press F1 to start UltiMax help

- Press F10 to start UltiMax general setup

- Draw a grid to your active image by pressing CTRL-G

- Scale can be activated by pressing CTRL-R

5.3.1. X-ray Acquisition

By clicking on the X-ray acquisition icon, the following window appears on the screen.

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Green text at the bottom tells you the status of the sensor. When “Ready For

Exposure” text appears you can take the x-ray with your equipment. The

image appears on the screen. At left you see the teeth map and at the

middle of the teeth there are few tools for taken images.

After taking an image you can select teeth from the map that are showing on

the image. After you have taken enough of images, press Exit -button to quit

X-ray acquisition.

By clicking on the Exit button, the following window will appear on the

screen.

Here you can give a name to the image, input x-ray settings and if you want

to specify extra info check the “Specify Extra Info & keywords” box. After

everything is specified, press the Save button. Or if you have taken many

images you can save all images without specifying any detailed information

by pressing Save All button. Delete button deletes one image and Delete

All button deletes every image you have taken. Cancel returns to X-ray

acquisition.

5.3.2. Scale

Scale button adds scale to the left and upper side of the image.

5.3.3. Grid

Grid button adds a grid over your image.

5.3.4. Annotations

This function allows you to add Arrows, Circles, Text and notes in different colors and sizes on an activated image. This function will never affect the original image. It is like a transparent layer that you can show or hide on the screen. You can also print the annotations together with the image. Simply load an image in a viewport, by double-clicking on the desired image from the image library and then press the Annotations button.

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This pop-up window will appear:

Press Pointer if you want to draw

an arrow. Press Text if you want to

write some text on the image.

Press Note if you want to add

some notes. (like a Post-note).

Press Ellipse if you want to add a

circle or an ellipse on the image. If

you want to delete an annotation,

press Select and press the delete

key on your keyboard.

You can change the color of the

annotation, by pressing Select,

then selecting the desired

annotation with the mouse. You

can then change the color to Red,

Blue or Green. You can change the

size of the annotation by pressing

Select, then select the desired

annotation with the mouse and change the size with the left and right arrows.

Depress the annotations button to save the current annotation(s). A small

green dot will appear above the image in the image library.

Sample of an annotation

5.3.5. Desktop

Press this icon to load another desktop or to modify a current desktop. When you press-and-hold the Desktop icon, this popup will appear:

Choose the desired desktop from the following.

DEFAULT:

- 1: 1024 x 768 resolution, 1 viewport.

- 2: 1024 x 768 resolution, 2 viewports.




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To create or modify an existing desktop layout:

Choose desktop 3, 4 or 5. Unlock the desktop. (Display - Desktop Panels -

Lock Desktop). Add or remove viewports with Display – Viewport. Modify the

size of the viewport with the viewports' lower right corner.

Add or remove Desktop Panels. Modify the size of the Desktop panels with

the panel’s lower right corner.

Panel move: Panel resize:

To save the modified desktop: Go to Display - Desktop panels - Save

Desktop.

To save/create a new desktop: Go to Display - Desktop panels - Save

Desktop as...

Enter a name, or resolution. When you have finished, you can load the new

desktop (Display - Desktop panels - Load Desktop).

5.3.6. Auto Contrast

This function automatically defines the contrast and brightness settings of the active image to optimum.

The auto contrast can be activated before or after acquisition (see Set Up).

The auto contrast function can only be activated once. Auto contrast will

automatically eliminate all previous manually changed settings. Auto

contrast settings will be saved if the image is saved or re-saved after

activation.

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5.3.7. Rotate

This function will rotate the active image, by 90 degrees to the right.

5.3.8. Invert

Clicking on this icon will change the positive display of an image into the negative one, or vice versa.

If you use this function on an X-ray image displayed in pseudo colours, the

image will be recalculated into complementary colours. By clicking a second

time on this icon, you will return to the original image. This function can also

be used to invert colour images or negatives.

5.3.9. Print

By clicking on the Print icon, the following window appears on the screen.

Select the printing mode: 1, 2, 3 or 6 images per page in the Pics/Page

window. The Selection window contains all the available images for this

patient. A scroll bar allows you to move the image gallery. To select an

image double-click on it. It will then appear in the Output window. The

Output window contains the images to be printed.

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- Add: Allows you to add a new image to be printed. Select an image in the

Selection window, then click on Add or double-click on the picture.

- Clear: deletes all images from the output window

- Delete: Allows you to delete a previously selected image from the Output

window.

- The images are printed together with the patient’s name, patient’s

birthday, doctor’s name and the saved comments.

- You can add additional comments in the Comment window.

- The Print Annotations tab allows you to print the annotations together

with the selected image.

- To start the printing click Print.

- To modify the printer settings click Setup Printer.

- To leave this function press Exit.

5.3.10. Save Image

This function allows you to store, or re-store, any activated image, after modification.

All modifications are stored with the image.

Using this function, you will obtain the following window.

Overwrite existing image?

Yes: the modified image will overwrite the previously activated one.

No: the modified image is stored as a new image.

The following message appears:

You have to change the name of the modified image. Click the Save icon to

save the modified image. This automatically closes the window. To leave

this function, without saving anything, click on Exit. You will then return to

the normal screen. The tab 'Original image' will disappear from the image.

5.3.11. Exit

Exit the program. The program will exit back to Windows, or back to your Practice Management Software, so allowing seamless integration with your Practice Management Software.

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5.4. Software Menu Bar and Other Features

Here are explained the most important parts of the UltiMax main menu and

other features.

5.4.1. File Menu

- Import picture, see 5.4.14

- Export picture, see 5.4.11

- Show patient list, recently

accessed from this

workstation

- Acquire, take x-ray image

with selected device

- Acquire FMX, take x-ray

image with FMX

- Video StillCap, capture an

image from connected

camera

- WDM Streaming Video,

record a video with WDM

compatible camera

- Import Picture directory,

see 5.4.15

- Export Picture directory,

see 5.4.12

- Twain Acquire, take picture

with twain compatible

device

- Fullscreen Mount, show images of patient full mouth if exists

- Print

- Reporter, make report of patient status. Default report is only in dutch.

- DicomNet

- Dicom Print

- Cam

5.4.2. Edit Menu

- Copy to clipboard: The image is copied into the

clipboard. The image is now available for all

Windows applications like Word, PowerPoint,

etc.

- Clear viewport: This will clear the actual

viewport. The image will not be deleted from the

image library.

- Delete image from disk

- Resample image, see 5.4.20

- Optimize

5.4.3. Display Menu

- Desktop Panels

- Viewport: This will set the number of

viewports (up to 4 viewports)

- Set current viewport to One-For-One:

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That means 1 pixel of the image = 1 pixel on the screen.

- Set current viewport to Fit: the actual image will be resized into the

current viewport.

5.4.4. Options Menu

- X-Ray Acquisition: choose the appropriate

X-ray device. (see also setup)

- Video Still Capture

- Calibration Table, see 5.4.9

- Macro's, see 5.4.17

- Customize Button Toolbar

- Setup

5.4.5. Language Menu

Use this menu to change the language of the

program. The program will be immediately

changed into the chosen language, except for the

additional modules. If the language doesn’t

change just press exit and launch the program

again.

5.4.6. Help Menu

- Help: The help file for the tool you are using will

appear.

- About: Shows the actual version of the program.

- Registration: see more at 5.4.19 Registration.

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5.4.7. General Settings

Here are the general settings for UltiMax software. UltiMax general settings can be accessed by pressing F10 button from your keyboard or from top menu Options -> Setup. Usually you don’t have to change anything.

General Settings tab lets you change the dentist name, file handling settings, software behavior and most important are the image format settings and filter parameters. These settings affect every image you take with the UltiMax software. Change these settings only if you know what you are doing.

Regional/Registration Settings tab lets you change your date format, teeth map settings and UltiMax license key location.

Display Settings tab lets you change default monitor in multimonitor environments and many other settings related to UltiMax looks.

Misc Settings & Maintenance tab lets you ask support directly by email, change your practice/patient management system connection settings and force the software to use only one CPU.

Modules tab shows what modules are enabled in your copy of UltiMax software. You can order more modules from us if needed.

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5.4.8. Brightness and Contrast Combo

The cursor in the middle of this window

allows you to modify the contrast and

brightness of an image simultaneously.

- To modify one of the settings of an

activated image, click on the cursor with

the left mouse button, hold it and move it,

until you obtain the desired setting.

- By clicking on one of the two icons, the corresponding function will be

automatically reset.

- Different settings can be used on each image displayed on the display

window.

If you save or re-save an image after having modified one of its settings,

these settings will be saved with it.

You can also modify the brightness and the contrast simultaneously, by

pressing the left mouse button. Just press and hold the left mouse button on

the image from the viewport.

Move Left - Right: This will modify the contrast

Move Up - Down: This will modify the brightness

5.4.9. Calibration Table

If you always acquire or import

images with the same resolution and

a known amount of pixels/meter, you

could use this table to avoid

calibration of each newly imported

image.

Example:

Sensor 912x1368 pixels

(Width/Height)

Active sensor area 20.064 x 30.1 cm

(square pixels)

912 / 20.064 = 45454 Pixels/Meter

5.4.10. Customize Button Toolbar

With this feature you can add, remove

or reorganize the icons on the toolbar.

- By using the 'drag & drop' method,

you can move the icons up and

down on the list.

- To disable the icons press the right

mouse button.

- Press Defaults to get back to the

default values (all icons are visible

and in the default order).

- Press Save to save your current

settings.

- Press Exit to return to the program.

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5.4.11. Export Picture

Use this menu option to export the image from the active viewport in the

chosen directory in the selected file format.

5.4.12. Export Picture Directory

Use this function to export images to other applications or through e-mail.

One or more images can be exported simultaneously to a specified path.

- Press Add to add the selected image to the export window below.

- Press Add all to add all the images from one folder to the export window

below.

- Press Add all + sub folders to add all the images and the sub folders to

the export window below.

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- Press to modify the destination folder.

- Press Export to export the image(s) to the selected destination folder.

- Press e-mail to send this/those image(s) through email. Your default

email application will be launched with the images as an 'attachment'.

Press Estimate to obtain the following screen:

- Choose the desired image format and compression.

- The destination file(s) and size(s) are mentioned in this window.

- Press Exit to return to the main screen.

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5.4.13. Image Library

All the available images on a given patient will be displayed in the image library.

The name of each image (if defined) is displayed under each image. Move

the mouse over the images and the date and time of exposure will be

displayed as a pop-up message. If all images cannot be displayed in the

image library at the same time, the software will display the most recent

images. In this case, a scroll bar will allow you to move around in your image

library.

- A green tab appears above an image indicating that there are

annotations for that image.

- A red tab appears above an image indicating that the actual image is an

original image.

- A blue tab appears above an image indicating that there are DFO

analyses for that image.

This image has annotations, a (or more) DFO analysis, but it is not an original image.

To send an image from the image library to the display you can:

- Double-click on the desired image from the library.

- Activate the display zone in which you want to display this image, then

select the desired image in the library, by double clicking on it.

The selected image is displayed in a dark grey frame (Active image).

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Within the library, you can create several subdirectories to manage your

images:

Go to the directory structure of the library and click the right mouse button.

Now you can insert or delete a new directory or group (up to 10 subfolders)

Subfolders can be automatically created.

See Options - Setup (F10) - General settings. See the section 'Default

patient folders'

If you want the subfolders 'X-Ray, Video, Other', insert under the 'Default

patients folders': X-Ray;Video;Other (You must separate each subfolder

with semicolon)

You can move an image from one subdirectory to another. Drag and drop

the image from the library to another subfolder. Release the mouse button.

Now, the image is moved from the actual subfolder to the new subfolder. If

you prefer to copy the image instead of moving it, you can modify the

settings in Options - Setup (F10) - General settings.

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See the section 'File handling'

Move image after drag: Ticked: The images will be moved to the subfolder.

Move image after drag: Not ticked: The images will be copied to the

subfolder.

5.4.14. Import Picture

Select a directory to import an image to the activated viewport. Bmp, jpeg,

dicom, pcx etc. are supported file formats. Choose 'Import as 16-bit

grayscale' if you want the image as a DICOM or choose 'Import as 24-bit

color' if you want the image as a JPG.

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5.4.15. Import Picture Directory

This feature gives you the ability to import in ONE STEP a complete set of

images (ex. digital camera). Select the desired directory. UltiMax will

remember your last choice. Double click on the stamps, or select under OK?

tab. Press Import and Exit.

All the selected images will be placed in the correct patient’s name and

directory.

From file menu you can change the file formats to import and the default

destination folder.

Desktop menu lets you the correct desktop size for your monitor, choose

between compact or expanded view and between thumbnails or detailed

view for each image.

From selection menu you can select all files, deselect all files or invert the

selection.

TIP: You can also double-click on Image description to change the name

of an image BEFORE importing it.

5.4.16. Info Bar

This is the info bar which is displayed by default under the image desktop on

UltiMax main display. Info bar shows the comments of the image, date, hour,

resolution, size of image, name of patient and name of practitioner. Use

Display - Desktop panels - Info bar to enable or disable this info bar.

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5.4.17. Macros

With this setup screen

you can create up to

12 macros. A macro is

useful if you want to

execute a couple of

functions under one

function key. The

macro recorder will

record all your handles

until you press the

CTRL-F12 keys

simultaneously.

To create a new

macro:

Press Add, Insert a

desired name under

Description. Choose

a function key

(Hotkey), Press Save, Press Record, Click on the desired tasks... video

capture, X-Ray... Press the CTRL-F12 keys simultaneously.

The macro is saved successfully. System wide is useful when the program is

not active (another Windows application can be active).

5.4.18. Regional Settings

Choose the desired date format dd/mm/yyyy or mm/dd/yyyy. Press on the

corresponding flag to change the teeth chart from European to US layout.

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5.4.19. Registration

With this option, you can upgrade your program to a more recent version or

a single user version to a multi-user version. In fact, it will re-program your

hardware key located on the USB port. The computer will generate a unique

code. (this is the Current code). If you need to upgrade your key please

contact Fimet Oy by e-mail [email protected]

Save the code onto a disk.

Email the code to us. Your default email application will be launched.

Use this button to check if the New code is valid for your current hardware key.

Load a code from a disk.

Upgrade the hardware key.

5.4.20. Resample Image

Use this function if you want to resample the actual image.

Example:

An image can be resampled for a presentation.

The resolution can be reduced or increased.

The image will not be distorted.

The aspect ratio will be preserved.

Press Resample to resample the image.

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6. IOX IMAGE VIEWER DATABASE REPAIR AND CONVERSION

IOX3 UltiMax system is delivered with iOX Image Viewer converter and

database repair tools. With the repair tool you can repair and prepare your

old iOX Image Viewer software database so it can be converted to UltiMax

without problems. The database converter converts your old iOX Image

Viewer patient database and images to UltiMax. These tools can be found

from UltiMax installation usb memory stick in “Tools” folder.

6.1. Repair and prepare iOX Image Viewer database

First backup your iOX Image Viewer database folder (by default C:\Program

Files\Fimet Oy\iOX Image Viewer\). Then install the Paradox Data Editor

from UltiMax installation usb memory stick “Tools\Paradox database

tool\PDESetup.exe”. After installation run the Paradox Data Editor software.

When Paradox Data Editor is open select File->Open from top menu.

Browse to the data folder in iOX Image Viewer database folder and open

Images.db. Then select Tools -> Check and Repair from top menu. Do the

same for Patient.db and Visit.db that are found from the same folder.

6.2. Convert iOX Image Viewer database to UltiMax

Conversion software can be found from UltiMax installation usb memory

stick “Tools\iOX Image Viewer converter\ IOXViewerConv.exe”.

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Browse iOX Image Viewer folder to the Database Root Folder row, UltiMax

Patients folder to the Mediadent Patients Folder row (by default

C:\UltiMax\Patients\) and UltiMax Data database file location (by default

C:\Program Files\Fimet Oy\UltiMax Data\MdData.db) to the Mediadent Data

Database row. Then click on Convert! Button. Conversion can take a while

depending on the size of your iOX Image Viewer database.

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7. HOLDER SET (OPTIONAL ACCESSORY)

The holder set is used to hold the sensor in correct position while radiating

the sensor with X–rays. The holder set includes specific holders for different

areas in the mouth (anterior, posterior, bitewings), reduction plates, aiming

rings and stems. Small amount of hygiene bags is also delivered with the

holder set. Wall holder and cord clips are also included. The material of the

holder set is polyamide (nylon) and they can be autoclaved.

Please note that the outlooks of the holder sets and accessories may vary.

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7.1. Contents

7.2. Wall Holder for Sensors

2 x Wall Holders are included. Using the cord clip prevents the sensor from

falling to the floor.

1. Fasten bracket to wall or other desired place by using the sticker or

screw

2. Slide holder itself onto bracket

3. Place sensor into holder and cord into the clip

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7.3. Disposable Hygiene Bags

Always use hygiene bags with holders! The enclosed photos are made

without bag only for this instruction. With all holders combinations, slide bag

onto holder and sensor.

7.4. Cord Clips

The cord clips can be used if necessary.

1. Fasten necessary amount of clips on stem.

2. Push cord in each clip.

7.5. Reduction Plate

Slide Reduction Plate in this way for all vertical or horizontal images

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7.6. Anterior Area Images

Use this combination for Images of Anterior Area from the center to the left.

Use this combination for Images of Anterior Area from the center to the left.

7.6.1. Upper Anterior Area Images

1. Insert sensor with holder into patient’s mouth

2. Ask patient to gently bite onto holder

3. Slide positioning ring close to patient

4. Align x-ray cone according to ring

5. Expose

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7.6.2. Lower Anterior Area Images





5. Expose

7.7. Horizontal Images

Use this combination for horizontal

images in:

1. upper right posterior area

2. lower left posterior area

Use this combination for horizontal

images in:

1. lower right posterior area

2. upper left posterior area

7.7.1. Posterior Lower Left Area Horizontal Image





5. Posterior Upper right Area Horizontal Image

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5. Expose

7.8. Vertical Images

Use this combination for

vertical images in:

6. upper right posterior area

7. lower left posterior area

Use this combination for

vertical images in:

1. lower right posterior area

2. upper left posterior area

7.8.1. Posterior Lower Right Area Vertical Image

1. Insert sensor with holder

into patient’s mouth




5. Expose

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7.8.2. Posterior Upper Left Area Vertical Image





5. Expose

7.9. Horizontal Bite Wing Images

Use this combination for horizontal bite wing images in bot left and right

area. Note! Insert stem into middle slot of positioning ring.


2. Ask patient to gently bite onto holder. Note! With bitewings the patient

bites on the block on the opposite teeth of the image area!!



5. Expose

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7.10. Vertical Bite Wing Images

Use this combination for vertical bite wing images in bot left and right area.

Note! Insert stem into middle slot of positioning ring.


2. Ask patient to gently bite onto holder. Note! With bitewings the patient

bites on the block on the opposite teeth of the image area!!



5. Expose

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8. GENERAL SPECIFICATIONS

Model X-ray Sensor System Model iOX3 UltiMax

EC Declaration of Conformity, CE-marking

Meets intent of Directive 93/42/EEC for medical devices

Product classification Class IIa

Protection against electric shock (IEC)

Class I

Connection type USB (Universal Serial Bus) version 2.0 high-speed device. Device maximum input power 100 mA / 5 V.

Humidity Operating: 5 - 85 %, storage & transportation: 10-93 %

Temperature Operating: 5 – 40 °C, storage & transportation: -40 – 70 °C

Ambient pressure 50 kPa to 106 kPa

International Protection Rating

IP67, Dust tight/sub water immersion up to 1 m

Fuses No fuses

Connecting cables Cables can be connected or disconnected in any order

Cable lengths Sensor cable 2.9 m (maximum 20 m with USB hubs)

Patient interface Type B device, type F patient interface

Net weight 0.14 kg (Both 900 and 600 sensors)

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Exposure time The normative exposure time is between 0.02 - 0.08 seconds using 60 - 70 kV voltage and 7 mA anode current with the DC X-ray. These values will vary depending on X-ray source, teeth location, etc. The correct settings can be found by testing the equipment in practice.

Exposure distance Optimal distance between X-ray focus and sensor is at least 200 mm (with long cone up to 400 mm). Longer distance gives sharper images.

X - r a y s e n s o r

> 2 0 0 m m

Main parts: 0501, iOX3 600 package with USB information data 0502, iOX3 900 package with USB information data 0503, iOX3 complete package with USB information data 0504, iOX3 holder set 0531, UltiMax software USB Dongle

Service There are no user-serviceable parts inside. Only manufacturer may open the device.

Disposal The device can be disposed of as electronic waste according to the local legislation or returned (at customer’s cost) to the manufacturer for recycling / disposal.

Manufacturer Fimet Oy Teollisuustie 6 FI-07230 Monninkylä Finland Email: [email protected] Website: www.fimet.fi

This product is manufactured according to Council Directive 93/42/EEC.

9. TROUBLESHOOTING

Contact us by email: [email protected].


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