EN
• INSTALLATION AND USER MANUAL
NOPTEN010M • May 2021
EN
OPTEO User manual NOPTEN010M Page 3/39
Index
1 INTRODUCTION .................................................................................................................................... 5
1.1 INTENDED USE ...................................................................................................................................... 5
1.2 INTENDED PATIENT POPULATION ............................................................................................................. 6
1.3 APPLICATION ENVIRONMENTS ................................................................................................................ 6
1.4 APPLIED PARTS ..................................................................................................................................... 6
1.5 FREQUENCY OF USE .............................................................................................................................. 6
1.6 PRESCRIPTION USE STATEMENT ............................................................................................................ 6
1.7 COMPLIANCE WITH STANDARDS ............................................................................................................. 6
1.8 POWER SUPPLY .................................................................................................................................... 7
1.9 INSTALLATION PRECAUTIONS.................................................................................................................. 7
1.10 LIABILITY AND OPERATORS ..................................................................................................................... 7
1.11 PACKAGING AND ENVIRONMENT ............................................................................................................. 8
1.12 MARKING AND LABELLING SYMBOLS ........................................................................................................ 9
1.13 ELECTROMAGNETIC INFORMATION........................................................................................................ 10
1.14 ELECTROMAGNETIC EMISSIONS ............................................................................................................ 10
1.15 ELECTROMAGNETIC IMMUNITY ............................................................................................................. 11
1.16 ENVIRONMENTAL RISKS AND DISPLACEMENT ......................................................................................... 12
1.17 MANUFACTURER IDENTIFICATION ......................................................................................................... 12
1.18 IDENTIFICATION LABEL ......................................................................................................................... 13
2 CONTENTS .......................................................................................................................................... 14
3 INSTALLATION ................................................................................................................................... 15
3.1 PRECAUTIONS ..................................................................................................................................... 15
3.2 EQUIPMENT INSTALLATION ................................................................................................................... 16
3.3 SOFTWARE INSTALLATION .................................................................................................................... 17
3.4 CONFIGURATION IN THE QUICKVISION IMAGING SOFTWARE ................................................................... 19
3.5 SHARING THE SENSOR AND BOX BETWEEN DIFFERENT WORKSTATIONS .................................................. 20
4 USE ....................................................................................................................................................... 21
4.1 PRECAUTIONS ..................................................................................................................................... 21
4.2 SENSOR PRINCIPLES ........................................................................................................................... 22
4.3 USE OF THE SENSOR WITH OR WITHOUT IMAGING SOFTWARE ................................................................. 22
4.4 ACQUISITION OF AN IMAGE ................................................................................................................... 25
4.5 EXPOSURE TIMES ................................................................................................................................ 27
5 HYGIENE AND MAINTENANCE ......................................................................................................... 28
5.1 HYGIENE AND DISINFECTION ................................................................................................................ 28
5.2 RECOMMENDED CLEANING AND DECONTAMINATION PROCEDURE ........................................................... 29
5.3 MAINTENANCE .................................................................................................................................... 30
6 TROUBLESHOOTING AND TESTS METHOD ................................................................................... 31
6.1 GENERAL ............................................................................................................................................ 31
6.2 IMAGE QUALITY ................................................................................................................................... 32
6.3 TESTS METHOD .................................................................................................................................. 33
7 SPECIFICATIONS ................................................................................................................................ 35
7.1 GENERAL SPECIFICATIONS ................................................................................................................... 35
8 ACCESSORIES .................................................................................................................................... 37
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The manufacturer, OWANDY RADIOLOGY, reserves the right to make modifications to its products or to
their specifications in order to improve the performance, quality, or ease of production. Specifications of
products or accessories may be modified without prior notice.
No part of this manual may be reproduced without the prior consent of the manufacturer, OWANDY
RADIOLOGY.
Language of original document: French.
Year CE marking assigned: 2012
OWANDY RADIOLOGY
2, rue des Vieilles Vignes
77183 Croissy-Beaubourg
FRANCE
Telephone : +33 1.64.11.18.18
Fax : +33 1.64.11.18.10
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1 Introduction
You have just received your Opteo new generation digital intra-oral radiology kit, with direct USB
connection. We thank you for the confidence you have in us and hope that this product will give you entire
satisfaction.
We recommend you to read this manual thoroughly before installation; following the guidelines for
installation and usage described in it will exclude risks to the patient and the care team. Please keep it
close to your equipment so you can refer to it at a later date.
Your sensor uses an X-ray sensitive electronic detector (the flat part at the bottom of the sensor) that
replaces the conventional film used for the acquisition of radiological intra-oral images. The X-rays are
automatically detected by the sensor which triggers image acquisition. The acquired image is displayed
almost instantaneously on the screen of the computer to which the sensor is connected. These digital
images can then be manipulated, analysed, saved as files or printed.
The development process of conventional films is thus completely eliminated as well as the possible
influences on image quality; such as the type and age of the chemical product, the temperature of the baths
or the development time.
The sensor is available in two sizes; depending on the kit you have ordered you received a size 1, a size 2
sensor or both:
• The size 1 sensor allows you to acquire the majority of intra-oral images (peri-apical and retro-
coronary) both vertically and horizontally.
• The size 2 sensor furthermore allows you to easily acquire horizontal “bitewing” images.
The instructions and information in this manual refer to both sensor sizes, unless specifically stated. The
size of the sensor is marked on the sensor itself.
1.1 Intended use
Opteo intraoral sensor is an hand held device used to provide digital images of human oral tissues and
teeth without the use of a conventional x-ray film.
Placed in the oral cavity of the patient, the sensor is subjected to X radiation from an x-ray generator (not
part of the device) a few tenths of a second. The sensor, upon radiation exposure, captures the image that
is then transferred and viewed on the practitioner's computer.
Opteo is used for diagnosis purpose by dental practitioners or radiologists.
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1.2 Intended patient population
Opteo sensor can be used with the following type of patient:
• Age peadiatric to geriatric
• Patient status/Health: the patient is conscious
• Nationality: multiple
Note: PATIENT is not an OPERATOR
1.3 Application environments
Opteo kit may be used in dental practice environment.
Opteo may be used in professional buildings or in a residential buildings. For the purpose of EMC
environment classification, both installations are classified as “Professional healthcare facility environment
and Home healthcare environment”.
1.4 Applied parts
During normal use, Opteo sensor is in contact with the patient via intraoral sensor and part of cable near
to the sensor. The intraoral sensor and cable are inside a protective sheath during use .These parts are
classified as Type
BF applied parts.
1.5 Frequency of use
The maximum duration of use correspond to 10 minutes. It’s very probable that for a given patient, total
contact will not exceed one hour in patient lifetime
1.6 Prescription Use Statement
Caution: Federal law restricts this device to sale by or on the order of a dentist or any other practitioner
licensed by the law of the State in which he practices to use or order the use of the device.
1.7 Compliance with standards
The Opteo kit is class IIa equipment within the meaning of the European Directive 93/42/CEE concerning
CE markings. The Opteo kit complies with the IEC60601-1, IEC 60601-1-6, IEC 60601-1-2 and IEC62304
medical devices standards.
It is necessary that the other components of the system that are possibly connected (computer and optional
peripherals) are compliant to standard IEC60950-1.
The intra-oral sensor is contained within a hermetic and sealed case (resistant to immersion). There is no
physical or electrical connection between the Opteo kit and the X-ray generator.
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1.8 Power supply
The power to the Opteo box is provided directly by the power supply of the USB cable connecting it to the
computer.
1.9 Installation precautions
Warning
The computer connected to the sensor MUST necessarily comply with standard IEC 60950
-1.
Warning
The Opteo
sensor is an electrical medical device requiring special precautions regarding
electromagnetic compatibility. Please observe the recommendations in this manual during the
commissioning and use of the equipment.
.
Warning
The use of cables or accessories other than those specified in this manual can cause an
increase in the emissions or a reduction in the immunity of the Opteo sensor.
1.10 Liability and operators
Installer: the installation of the kit requires computer skills relating to both equipment and software. Follow
the recommendations and guidelines of the installation chapter to install the equipment and software.
User: the kit must be used by a dental practitioner or radiologist with computer skill
Warning
The sensor should never be opened by the user. Only the manufacturer is authorised to open
and make repairs to the sensor. Return the equipment to the distributor in case of malfunction
and/or if the documentation you possess does not contain the necessary information for the
(authorised) maintenance of the malfunctioning equipment.
Warning
Any modification of the
Opteo
device is forbidden. All repairs of this same device can only be
performed by Owandy Radiology personnel.
The manufacturer will not be liable if:
• Interventions or repairs have been made by persons without the authorization of the manufacturer
or distributor and are not part of accepted interventions.
• The equipment is used with an installation that is not compliant with the applicable standards and
decrees - in particular when not compliant with the IEC 60601-1 standard relating to the security
rules for electro medical systems. Make sure the installation of the equipment is compliant with the
applicable regulations.
• Used in ways other than those mentioned specifically in this manual (use of the kit in normal
conditions of use and in compliance with its intended purpose).
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1.11 Packaging and environment
Transport, storage and environment: the kit is supplied in protective packaging (protection against
physical impacts and antistatic packaging). It must be stored under the following conditions:
Ambient temperature: -10°C to +70°C / 14°F to 158°F
Relative humidity: <95% without condensation
Atmospheric pressure: 500hPa to 1060hPa
Operation: the kit has been designed for normal use under the following conditions:
Ambient temperature: +10°C to +40°C / 50°F to 104°F
Relative humidity: 30% to 75%
Atmospheric pressure: 700hPa to 1060hPa
Equipment packaging for return to distributor: should a return to the distributor be necessary, make
sure to package the sensor and box kit in its original packaging after having cleaned it thoroughly.
Documentation loss: all kits are shipped with its documentation. Please contact your distributor for a
replacement manual if this documentation is lost.
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1.12 Marking and labelling symbols
These symbols are used on the product labels and inform you about the compliance with standards and
the technical specifications of the component.
Direct current.
Type BF applied parts, IEC 60601-
1
Insulation class II
Important information: follow the
instructions for use
The CE marking certifies
that this product complies
with European directive
93/42/EEC and its revised
versions..
Name and address of manufacturer
Product identification code
Serial number
Manufacturing date (year and
month)
Sensor waterproofness standard,
EN/CEI 60529 regulation.
Only the part of the sensor
putted in month, complies with
this standard
.
Storage condition: temperature
limitations.
Storage condition: relative
humidity limitations
Storage condition: Atmospheric
pressure limitations.
In some of its parts, the device contains materials and liquids that, at the end of the lifespan of the unit,
must be disposed of at the appropriate disposal centres
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1.13 Electromagnetic information
Medical electrical equipment needs special precautions regarding EMC and needs to be installed and put
into service according to the EMC information provided in the accompanying documents
Portable and mobile RF communications equipment can affect medical electrical equipment.
The equipment can be installed both in professional buildings and in residential buildings. Residential
buildings, according to IEC 60601-1-2 4th edition, are intended to be connected to dedicated power supply
system (normally fed by separation transformers).
For the purpose of EMC environment classification according to IEC 60601-1-2 4th edition, both
installations are classified as “Professional healthcare facility environment and home healthcare
environment”
Warning
Opteo should not be used adjacent to or stacked with other equipment; if adjacent use is
necessary, Opteo has to be observed to verify if it operates in a normal way.
Interference may occur in the vicinity of equipment marked with the symbol
Warning
Portable and mobile RF communications equipment should be used no closer to any parts of
Opteo including cable. Minimum distance 30 cm.
1.14 Electromagnetic emissions
In accordance with IEC 60601-1-2 4
th
edition standard, Opteo is suitable for use in the electromagnetic
environment specified below.
The customer or user of the system must ensure that it is used in the said environment.
Guidance and manufacturer’s declaration – Electromagnetic emissions
Opteo is suitable for use in the specified electromagnetic environment. The purchaser or user of the Opteo
should
assure that it is used in an electromagnetic environment as described below:
Emissions test Compliance Electromagnetic Environment
RF emissions
CISPR 11
Group 1
Opteo
nearby electronic equipment.
RF emissions
CISPR 11
Class B
Opteo is suitable for use in
establishments and those directly connected to the public low-
domestic purposes.
Harmonic emissions
IEC 61000-3-2
Class A
Voltage fluctuations/
flicker emissions
IEC 61000-3-3
Complies
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1.15 Electromagnetic immunity
In accordance with the IEC 60601-1-2 4
th
edition standard Opteo is suitable for use in the electromagnetic
environment specified below.
The customer or user of the system must ensure that it is used in the said environment.
Immunity
test
IEC 60601-1-2
test level
Compliance
level
Electromagnetic environment
Electrostatic
discharge (ESD) IEC
61000-4-2
8 kV contact
2/4/8/15 kV air
IEC 60601-1-2
Test level
Floors should be wood, concrete or
ceramic tile. If floors are covered with
synthetic material, the relative
humidity should be at least 30%
Radiated
electromagnetic field
IEC 61000-4-3
3 V/m
80 MHz to 2.7 GHz
IEC 60601-1-2
Test level
Portable and mobile RF
communications equipment should
be used no closer to any part of Opteo
including cable.
Minimum distance 30 cm
Electrical fast
transient/burst
IEC 61000-4-4
2 kV for power
supply lines
1 kV for input/output
lines > 3 m
IEC 60601-1-2
Test level
Mains power quality should be that of
a typical commercial or hospital
environment
Surge
IEC 61000-4-5
0.5/1 kV differential
mode
0.5/1/2 kV common
mode
IEC 60601-1-2
Test level
Mains power quality should be that of
a typical commercial or hospital
environment
Conducted
disturbances
induced by RF fields
IEC 61000-4-6
3 V
150 kHz to 80 MHz
6 V
ISM frequencies
IEC 60601-1-2
Test level
Portable and mobile RF
communications equipment should
be used no closer to any part of
Opteo, including cable.
Minimum distance 30 cm
Voltage dips, short
interruptions and
voltage variations on
power supply input
lines
IEC 61000-4-11
10 ms – 0 % a 0°, 45°,
90°, 135°, 180°, 225°,
270°, 315°
20 ms – 0% a 0°
500 ms – 70% a 0°
5 s – 0%
IEC 60601-1-2
Test level
Mains power quality should be that of
a typical commercial or hospital
environment. If the user of the Opteo
requires continued operation during
power
mains interruptions, it is
recommended that the Opteo be
powered from an uninterruptible
power supply or a battery
Power frequency
(50/60 Hz) magnetic
field
IEC 61000-4-8
30 A/m
IEC 60601-1-2
Test level
Power frequency magnetic fields
should be at
levels characteristics of
a typical location in a typical
commercial or hospital environment
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1.16 Environmental risks and displacement
Some parts of the device contain materials that, at the end of the unit’s lifecycle, must be disposed of at
appropriate disposal centres. In particular the device contains the following materials and/or components:
• Non biodegradable plastic materials
• Copper
• Printed circuit boards with electronic components
• Metal parts
Note Information for users of European Community according to 2011/65/EU Directive on the restriction of the use of
certain hazardous substances in electrical and electronic equipment
The symbol with the waste bin crossed on the equipment or its packaging, indicates that the product must
be separately collected from other waste at the end of its life. The separate collection of the present
equipment that has reached end of its life is organised and managed by the manufacturer.
The user who wishes to dispose of this equipment must contact the manufacturer and follow their system
to enable the separate collection of the equipment at the end of its life.
Suitable separate waste collection for the subsequent start of the equipment discarded for recycling, for
treatment and for environmentally friendly disposal, contributes in preventing possible adverse effects on
the environment and health and promotes the reuse and/or recycling of materials of which the equipment
is comprised.
Illegal disposal of the product by the holder implies the application of administrative sanctions provided by
law.
1.17 Manufacturer identification
Manufacturer:
Owandy Radiology sas.
2, rue des Vieilles Vignes
77183 Croissy-Beaubourg
FRANCE
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1.18 Identification label
Opteo sensor size 1 identification label
Opteo sensor size 2 identification label
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2 Contents
Your Opteo kit consists of the following elements (illustrations may vary from items supplied):
An Opteo sensor - size 1 or size 2
(cable of 3m / 9.9foot)
1 self-adhesive sensor wall support
A bag of disposable single-use hygienic
protective sleeves (compatible with size 1 and
2 sensors)
An USB Stick with the sensor calibration files and
manuals
1 Mouse pad
A Packing list
A « Quick Start guide »
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3 Installation
3.1 Precautions
Warning
The kit must be handled with care, minimise the twisting, pulling and bending of the attachment
cable. Do not step or roll on the cable. Do not pull on the cable itself but on the connection plug
to disconnect the USB cable.
Warning
To avoid interferences in the image, do not use the system close to strong magnetic fields and
avoid proximity to electrostatic emission
sources.
Warning
Read paragraph 1.
9 “Installation precautions
” to ensure the installation complies with the
standards
Install your imaging software before the installation of the kit, its drivers and O.S.P. tools and the installation
files of the sensor.
3.1.1 Recommended minimal configuration
Warning
Any computer configuration that does not comply with the minimal recommended configuration
can prevent the starting or proper functioning of the sensor kit. Verify the specifications of the
computer(s) before the installation.
Operating system Windows 10 / 32 and 64 bits
Computer
Motherboard
USB port
Compliant -IEC60950-1
Intel 3GHz Chipset and processor
USB 2.0 High-Speed
Graphics card
Monitor
1Go
High resolution 1024x768 (15inch)
RAM memory
Hard disk
2Go
500Go
CD-ROM drive
Backup system
24x
External/removable disk, CD-ROM/DVD…
Printer
Keyboard and mouse
Laser, inkjet, thermal
At acquisition workstation
Opteo kit with appropriate drivers
Imaging software
X-ray generator with electronic timer
Warning
The computer connected to the sensor MUST be compliant with standard IEC 60950
-1.
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3.1.2 Setup guidelines
The computer and the screen with which the sensor and the box are used should preferably be situated
close to the chair, within the field of vision of the practitioner, to allow for immediate use. Provide visual
access for the patient to be able to share the radiological information with him/her.
The screen must be placed so as to avoid any reflections or direct overhead illuminations that could be
detrimental to the visualization of the radiological images. It must be set up (contrast and brightness) to
display as many grey levels as possible in the image.
The X-ray generator has a great influence on the quality of the acquired images. The kit is compatible with
any kind of generator, be it high-frequency or conventional. The generator must be equipped with an
electronic timer (allowing for very short exposure times) and must emit a dose sufficient for the acquisition
of a good image (with enough grey levels). Make sure that your generator is not worn as the dose emitted
will be insufficient and could influence the quality of the acquired image. The energy emitted by a generator
diminishes over time; when in doubt have your generator checked by a qualified technician. Make sure he
had of the generator is stable, any movement of the head will induce movement blur in the acquired image.
3.2 Equipment installation
3.2.1 Connection
The Opteo sensor is fitted directly to a cable equipped with a USB connector linking it directly to
the computer.
Warning
Make sure the USB port of the computer is preferably a USB 2.0 port.
Only use
USB 2.0 cables
with a USB 2.0 port. Each USB cable should not be longer than 3m / 9.8ft. The kit is compatible
with USB 1.1 ports but with reduced image transmission speed.
The USB cable can be connected / disconnected without the need to power down the computer.
Check that the sensor is correctly connected: if the sensor toolbar turns green after removing the sensor
from its support, it is powered correctly.
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3.2.2 Sensor support
The sensor can be placed on its self-adhesive support supplied with the kit.
The support is compatible with sensors of size 1 or size 2.
This support can be fixed on any type of flat surface: worktop or a part of the chair.
The sensor will then be inserted into the fork of the support taking care not to impede
the cable.
Warning
Do not mount the wall support upside
-
down or horizontally, the sensor could fall on the ground
and be damaged.
3.3 Software installation
Install the Owandy QuickVision (or third party) imaging software and check its proper functioning before
installing the equipment and its drivers. Refer to the software manual for the installation instructions.
Warning
You need administrator rights for the installation and use of the software and equipment. Please
contact your IT
specialist to create a suitable user account.
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3.3.1 Installation of OSP and the drivers
Warning
The
Opteo drivers are only compatible with Windows 7, 8, 10
(32 and 64 bits) operating systems.
To install the drivers and the diagnostic tools:
1. Connect the USB stick to the PC, or download drivers and diagnostic tools on our website
www.owandy.com/support
.
2. Select OPTEO, and follow instructions.
3.3.2 Sensor installation files
Warning
Each kit is provided with a sensor installation USB stick of its own; the serial number of the
sensor is written on the USB stick and on the connection box. You can therefore not use the
same USB stick to install several sensors; each sensor requires its own USB stick.
Before installing the sensor installation files, make sure that:
• The drivers of the kit are installed.
• The imaging software is not started.
1. Insert the USB stick
2. Open CALIBRATION partition
3. Click on install.bat
4. Close the window
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3.3.3 OSP updating
If you need to update driver:
1. Connect the USB stick to the PC, or download the OSP on our website www.owandy.com/support
2. Select OPTEO, and follow instructions.
3.4 Configuration in the QuickVision imaging software
To be able to use your kit with the Owandy QuickVision imaging software you must configure your
equipment.
1. Start the imaging software
2. Click on the “Set up” button in the main screen.
3. Select “Owandy Digital Intraoral” under the “Intra-oral sensor” option in the window that appears.
4. Click on “Set up” at the right of the menu.
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In the configuration window:
◄ Select the “Opteo
V2” kit.
◄ Set the activation
time of the box (default
3min).
◄ Set the inlay and
size of the date & time
and exposure
parameters in the
acquired image.
◄ Select the image
treatment (*).
(*) When the “Film alike” option is activated, the contrast depends on the exposure time. Adjust the X-ray dose on
the generator to obtain a good image.
(*) When you select the option “Auto contrast” the contrast is constant. Exposure errors are corrected automatically,
which reveals noise in badly exposed images.
In both cases, the exposure bar (blue/green/red) helps to find the correct exposure of the images.
5. Click on “OK” to confirm your choice.
6. Then click on the “Save” button.
The use of the kit is identical to the use of the Owandy XIO StandAlone software described below.
3.5 Sharing the sensor and box between different workstations
Sharing the sensor allows you to use one or more sensors in turn in a practice with multiple chairs. It is
recommended to link the different workstations in a network to allow for the central storage and sharing of
the images.
A USB port must be plugged into each workstation to allow for an easy connection of the box. Windows will
automatically recognise the equipment when it is connected and it will be available immediately for image
acquisition.
To enable the sharing of a kit between different workstations, it is necessary to first install the imaging
software for the acquisition of the images, the drivers, O.S.P. tools and sensor installation files on all the
computers with which your Opteo will be used.
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4 Use
4.1 Precautions
Warning
ALWAYS use protective sheaths to cover the sensor, the part of the cable proximal to the sensor
and the positioner, if used.
Warning
ALWAYS keep (or ask the patient to keep) in place the
protective sheath during the use.
Warning
Make sure the sensitive surface (the flat surface) of the sensor is directed towards the X
-
ray
generator. The active surface of the sensor is marked by a frame. The back of the sensor
(rounded) does not react to X-rays and does not produce an image on-screen.
Warning
The kit must be manipulated with care, minimising the twisting, pulling and bending of the
attachment cable. Do not step or roll on the cable. Be careful not to pull on the cable when
removing the hygienic protective sheaths.
Warning
Do not pull on the cable itself, but on the plug to disconnect the USB cable.
Warning
Even though the sensor is resistant to impacts, it is strongly recommended to not let it fall on
the floor. If a physical impact should exceptionally happen, contact your distributor and do not
try to intervene yourself.
Warning
Do not ask the patient to bite on the sensor or cable.
Warning
Use of a mobile phone or an RF communications device near the Opteo sensor may affect the
sensor.
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4.2 Sensor principles
4.2.1 Sensor
The sensor’s sensitive area is delimited by a horizontal line; the area below this line is not sensitive to X-
rays. When the sensor is placed in the mouth it is necessary to check that this area is turned towards the
radiation source and that the whole sensitive area is irradiated.
Active surface Sensor’s rear shell: inactive surface
4.2.2 Sensor activation
The sensor automatically puts itself on standby after a period which
can be configured in the configuration window (see “3.4 Configuration
in the Owandy imaging software” - the default period is 3 minutes).
The sensor’s toolbar is then in its red state.
To activate your sensor physically, just remove it from its support
and/or give it a slight jerk. The Opteo is equipped with a gravity
sensor which will detect this movement and will so activate the
embedded electronics. The sensor’s sensitivity to gravity is
programmed so as not to activate the Opteo intra-oral sensor
inopportunely by an involuntary movement
.
Warning
When activating the sensor physically, take care to hold the sensor by both sides of its shells
and not by the cable in order to avoid any risk of the cable connections breaking or the sensor
falling and breaking.
4.3 Use of the sensor with or without imaging software
4.3.1 Modes of operation
The sensor kit can function in three ways:
• Through the imaging software QuickVision: to use this mode, launch QuickVision software and
take an image. The image will open directly in the software, without manipulation on your part.
Other options (ex: selection of the tooth for the next acquisition) are available. To do this, please
refer to the QuickVision User Manual
• Through the Twain protocol: to use this mode select “Owandy Intra Oral X-rays…” in the TWAIN
acquisition option of your imaging software. Subsequently start the TWAIN acquisition; the interface
is identical to that of the independent mode described below.
• In independent mode: the independent software program can be started with the icon (on
the Windows desktop) or by starting an Owandy software program. This memory resident software
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package allows the use of the sensor outside any software program. If an image is acquired without
a program ready to receive it, the resident program will display the image on-screen for a few
seconds and save it in the “C:\Program Files\OWANDY\OSP - XRAYS BOX
STANDALONE\StandAlone\Data” directory on the hard disk.
You can retrieve the image when you launch your imaging software
Fot these three ways, a sensor icon appears in the Windows taskbar, next to the clock. The colour of the
icon indicates the state of the sensor:
Red: sensor inactive
Yellow: sensor initialising
Green: sensor ready for acquisition
Warning
When the sensor is in "ready status" (green icon) and receive X
-
ray, it acquires image also
in case the user software has not been activated or a patient has not
been selected.
4.3.2 Sensor toolbar
It is possible to display the sensor toolbar by clicking with the right mouse button on the sensor icon in the
taskbar. The colour of the sensor toolbar indicates the state of the sensor:
Red: sensor inactive
Yellow: sensor initialising
Green: sensor ready for acquisition
Options of the sensor toolbar:
◄ Orientation of the sensor (vertical or horizontal), double-click the icon to change
the orientation of the sensor.
◄ Activate/deactivate the sensor.
◄ Selection of the sensor to activate (case of simultaneous use of a size 1 sensor
and size 2 sensor on the same computer).
◄ Iconize the toolbar in the taskbar.
Warning
The sensor automatically switches to standby mode after a few minutes of not being used; the
sensor toolbar turns red.
Check that the sensor toolbar is displayed in green before each acquisition.
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4.3.3 Configuration menu
A right-click on the sensor icon in the taskbar or on the sensor toolbar displays the configuration menu:
X-ray sensor
Displays the sensor toolbar.
Start when Windows starts
Once checked, the StandAlone program will be launched
each time your computer is started.
Configuration
Displays the configuration menu (see “3.4 Configuration in
the Owandy imaging software”).
Display new images for Adjusts the display time of the image.
Remaining images
Allows you to browse through the images waiting to be
transferred.
If no image is acquired this option is not
displayed.
Exit
Closes the resident software program. Warning: the
acquisition will no longer be available until the resident
program is restarted.
4.3.4 Image transfer interface
Options of the image transfer interface:
Image display When an image is selected, it is displayed on a blue background.
“Load” button Transfers the selected image to the software program.
“Cancel” button
Cancels the image selection and starts the toolbar for a new
acquisition (only when in a software program).
“Preview” button
Displays the selected image full-screen.
“Email” button
Opens a blank email and attaches the image in a zip file.
“Delete” button
Deletes the selected image.
“Delete on load” option
Deletes the selected image from the list after it has been
transferred to a software program.
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4.4 Acquisition of an image
4.4.1 Acquisition procedure
The image acquisition goes through several steps:
1. Before being able to acquire an image with the sensor, you need to start the computer to which it
is connected and start the imaging software. Check that the sensor toolbar or the sensor icon in
the task bar is green.
2. Program the different parameters (exposure time, etc.) on the X-ray generator (see “4.5 Exposure
times” for more information).
3. Cover the sensor with a hygienic protective sheath making sure to cover a sufficient length of cable.
4. A set of positioners is provided with the kit to place the sensor in the different parts of the mouth;
their use is recommended to ensure the sensor is positioned perpendicularly to the X-ray beam.
The sensor can also be positioned manually, maintained by the patient as with conventional film.
This can be necessary for children with a small oral cavity. Position the sensor in the mouth, behind
the tooth of which you want to acquire an image. If you do not use a positioner, a cotton roll can be
helpful to position the sensor parallel to the tooth.
Warning
ALWAYS use protective sheaths to cover the sensor, the part of the cable near to the sensor
and the
positioner, if used.
Warning
ALWAYS keep (or ask the patient to keep) in place the protective sheath during the use.
Warning
Turn the sensitive surface of the sensor (the flat surface) towards the generator; if it is facing
the other way, the
sensor will not be able to acquire images.
5. Position the generator so as to cover the whole sensitive area of the sensor. The paralleling
technique is strongly recommended and the use of positioners allows you to correctly place the
generator thanks to the aiming ring.
6. Activate the generator. The sensor toolbar turns yellow to indicate the treatment and transmission
of the acquired image. Once the image treated, it appears in the imaging software and the sensor
toolbar turns green allowing a new acquisition.
Warning
In case the sensor is used with intra oral system with low mA emission (i.e. hand held systems
that typically provide 2mA), it is necessary to position X
-
ray source as close as possible to the
sensor, without any extension and set the expo
sure time between the range 50ms and 500ms.
Without this setup, the dose is not enough to trigger the sensor and acquire the image.
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4.4.2 Imaging software functions
An exposure percentage is displayed in the acquired image:
• 0 to 80% - under-exposed image, the X-ray dose is too low; increase the X-ray dose on the
generator.
• 80 to 120% - correctly exposed image
• 120 to 200% - over-exposed image, the X-ray dose is too high; reduce the X-ray dose on the
generator.
When the image is displayed in the Owandy QuickVision imaging software, a coloured bar appears in the
top part of the image, this is the exposure bar. This function is available only to users of the Owandy imaging
software.
The white cursor displayed in this bar indicates the exposure level of the image:
• If the cursor is in the green, the image is correctly exposed.
• If the cursor is in the red, the image is over-exposed; reduce the exposure time on the generator.
• If the cursor is in the blue, the image is under-exposed; increase the exposure time on the
generator.
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4.5 Exposure times
Recommended exposure times in seconds for the Owandy Radiology X-ray generators Ow-RX:
Voltage/Current
65 kV 6 mA
Lower incisor / canine
0.06 – 0.09
Lower premolar
0.06 – 0.10
Lower molar
0.07 – 0.11
Upper incisor / canine
0.08 – 0.10
Upper premolar
0.08 – 0.11
Upper molar 0.11 – 0.16
Front bitewing
0.06 – 0.09
Rear bitewing
0.11 – 0.16
Reference conditions:
• Adult patients, or paediatric patients of average size
• Distance focal spot to sensor: 200 mm
• Total filtration: equivalent to 2,5 mm Al
The values indicated in the table above can vary from one generator to another. It is the responsibility of
each user to calibrate his/her doses before use.
If an image is over or under-exposed, it can be corrected afterwards with the imaging software (contrast,
brightness, etc.) to improve its visualisation.
The table below allows you to note the exposure times specific to your generator:
Exposure Time tables
Lower incisor / canine
Lower premolar
Lower molar
Upper incisor / canine
Upper premolar
Upper molar
Front bitewing
Rear bitewing
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5 Hygiene and maintenance
5.1 Hygiene and disinfection
5.1.1 USB Connector
The connector does not require any particular maintenance, it should be cleaned using a cloth and non-
abrasive detergents
.
5.1.2 Sensor
To avoid cross-contamination between patients during use, it is necessary to protect the sensor with
hygienic single-use protective sheaths (FDA cleared for the USA, CE marked for Europe). Some hygienic
protective sheaths suited for your region are provided with each system.
Before each use on a patient, the used sheath should be thrown away and the sensor disinfected applying
a high level disinfection procedure (see “5.2 Recommended cleaning and decontamination procedure”). A
new protective sheath is applied to the sensor for each new patient. We recommend the disposal of the
hygienic protective sheaths with the biologically hazardous waste of your practice.
Validated protections for North America: BANTA HEALTHCARE or TIDI PRODUCTS X-ray sensor
sheaths, STERI-SHIELD PRODUCTS RS barriers.
Warning
Do not pull on the cable when removing the used
protective sheath.
5.1.3 Cables
The cable can be cleaned with caution by using a disinfecting wipe. Hold the sensor with one hand and,
with the other hand, apply a disinfecting wipe from the side of the sensor along the first 20cm / 8inch of the
cable without pulling on the cable; subsequently clean the remainder of the cable in segments of 20-30cm
/ 8-12inch with as little pinching of the cable as possible, the wipe should slide without applying force.
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5.2 Recommended cleaning and decontamination procedure
Remove the hygienic protective sheath (dispose of it appropriately with the contaminated waste).
Vigorously wipe down the sensor to remove any visible residues. If necessary rinse with copious amounts
of water. Then place the sensor in the disinfecting agent.
Warning
Only immerse the sensor and the head of the positioner or sensor connection cable in the
disinfectant for 15min, never immerse the connector on the box side of the positioner or sensor
connection cable in the liquid.
During the immersion, brush the submerged parts with a soft brush. Then rinse thoroughly the
sensor and the positioner or the sensor connection cable with copious amounts of fresh water.
Warning
Do not put the sensor in a sterilizer or an autoclave, the high temperature and excessive high
pressure will seriously damage the electronics of the sensor a
nd connectors.
Warning
Do not clean the sensor with inappropriate instruments (knife…).
If the sensor, positioner or sensor connection cable are not being used immediately upon rinsing, as in the
case of allowing them to air-dry overnight at the end of a working day, they should be rinsed with sterile
water.
When the sensor, positioner or sensor connection cable are not being used, to protect them from any
damage, it is recommended to store them in their box or to hang them in the sensor wall support.
Even when using protective sheaths, the sensor should be disinfected regularly. Immerse the sensor in
cold sterilisation fluid in accordance with the instructions of the manufacturer after having cleaned it from
all residues. Never leave the sensor immersed for longer than necessary.
5.2.1 Recommended decontaminating product for North-America
The sensor being sealed watertight and to minimize the potential for device-associated infections, the
sensor and the part of the positioner or sensor connection cable inserted in the mouth shall be disinfected
with an FDA-cleared high level disinfection agent following the instructions of the manufacturer for use,
storage, handling and warning.
The following disinfectant agent has been validated with the sensor: CIDEX OPA solution (0.55% Ortho-
phthalaldehyde solution). The maximum soaking period is 24 hours.
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5.2.2 Recommended decontaminating products outside North-America
The following disinfectants are compatible with the sensor and the part of the positioner or sensor
connection cable that is inserted in the mouth:
• 2% Sodium Hypochlorite (maximum immersion time of 24 hours)
• Ethyl alcohol (maximum immersion time of 24 hours)
• Quaternary ammonium
5.3 Maintenance
5.3.1 Computer data-protection
Your patient and image database must be backed-up regularly to be able to recuperate them if needed (in
case of hard disk or computer problems). It’s recommended to do the back up once a week.
Ask the advice of your IT specialist with regard to the backup system that is best suited to your computer
configuration (external or removable hard disk, CD-ROM or DVD writer, etc.). Test and store the copies in
a safe place. It’s recommended to do the system back up twice a month.
NOTE: The device is not serviced or maintained while in use with the patient
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6 Troubleshooting and tests method
If an error occurs during operation, check the different items in this troubleshooting guide. If you cannot
resolve your problem please contact your distributor.
6.1 General
Symptom Cause / Solution
The kit does not power up or it
does not acquire images.
• Check that the active surface of the sensor is directed towards the X-
ray generator and is positioned correctly in the field of the X-ray beam.
• Check that the kit is correctly configured in the imaging software and
that the drivers are correctly installed.
• Check the connection between the sensor and the PC, and ensure that
the PC is powered externally.
• Check that the generator is emitting X-rays (with another sensor or with
conventional film).
No image appears on the
screen.
• An error has occurred during acquisition, disconnect the cable and wait
a few seconds before reconnecting it.
• Check that the outer sheath of the cable connection from the sensor
does not show any signs of tearing.
The sensor is slightly warm.
This is normal. The temperature of the sensor can exceed 12°C (54°F)
when the kit is activated for a prolonged period (e.g. when taking many
consecutive images) and has no bearing on the functioning of the kit.
• Reduce the standby time in the configuration screen.
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6.2 Image quality
Symptom Cause / Solution
The images are cut off, e.g.:
The sensor is badly positioned with regard to the X-ray beam.
• Reposition the sensor, making sure it is well within the field of the
X-ray beam.
•
Use the positioners provided with the sensor for optimal
positioning.
The images are too light or contain
noise, e.g.:
Film alike mode Auto contrast
mode
• The image is under-exposed, the X-ray dose is too low; increase
the X-ray dose on the generator.
The percentage that is
displayed in the image indicate the exposure level:
o 0 to 80% - under-exposed image
o 80 to 120% - correctly exposed image
o 120 to 200% - over-exposed image
• Check the dose emitted by the X-ray generator, due to age the
dose can be insufficient.
Have the generator checked by a
technician when in doubt.
• The generator is positioned too far from the patient with regard
to the selected dose.
• Check the parameters of your monitor (contrast and brightness)
and avoid reflections on the screen.
The images are too dark, e.g.:
• The image is over-exposed, the X-ray dose is too high; reduce
the X-ray dose on the generator. The
percentage that is
displayed in the image indicate the exposure level:
o 0 to 80% - under-exposed image
o 80 to 120% - correctly exposed image
o 120 to 200% - over-exposed image
• Check the parameters of your monitor (contrast and brightness)
and avoid reflections on the screen.
Grey levels seem to be missing in
the image (flat areas of grey appear).
• Check the quality and parameters of the monitor.
• Check the connection of the cable of the screen at the side of the
graphics card and the monitor.
• Check th
e screen configuration under Windows (screen
configuration panel, it must display colours in at least 24bits.
The image is blurred. Re-acquire the image:
• The patient has moved during the exposure.
• The generator head was not stabilised and has moved.
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6.3 Tests Method
It is recommended to the practitioner to test regularly the quality of the imaging digital devices complete
line.
You can refer to the standard IEC 61223-3-4 (V2000) which describes the acceptance tests imaging
performance of dental X-ray equipment.
Two parameters have to be inspected to verify the performance of both the X-ray generator unit and the
Intra-oral sensor (see chapters 5.8 and 5.9 of the standard IEC 61223-3-4):
• Spatial resolution (pl/mm)
• Low contrast resolution (mm)
To control these two parameters, you can use a
phantom test object, placed directly in front of the exit of
your Xray unit collimator, and in which you introduce the intra-oral sensor.
Example of an intra-oral test phampton (QUALIMEDIS ref. OTN):
Various circular and rectangular guides sizes
for X-ray units collimator centring
Spatial resolution Phampton test details
Lead thickness: 0.05mm
Spatial resolutions of 2.0, 2.5, 2.8, 3.1, 5.8, 6.3
pl/mm
Low contrast resolution Phampton test details
Ø 1.0, 1.5, 2.0, 2.5mm
Intra-
oral sensor location compatible with
different sizes
Collimator
centring guide (compatible with
rectangular and circular design)
- Aluminium filter 6.0mm thickness,
- Plexiglas filter 3.0mm thickness,
- Aluminium filter 0.5mm thickness.
Intra-oral sensor location
• Spatial resolution control object:
• Low contrast resolution control object:
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The image quality control acquisition goes through several steps:
1. Before acquiring an image with the sensor, you need to
position the intra-oral test phampton just in front of the
collimator of your X-ray generator unit. You can inclinate
the tubehead in vertical position to manage this operation,
or put the test phampton directly on a table and move the
tubehead collimator directly on it.
2. Place the sensor in its location dedicated for. Take care that
the sensitive surface of your sensor covers completely all the details objects of the low-contrast
and spatial resolutions phamptons (see image opposite).
3. Set up your X-ray generator with your usual radiological paramaters corresponded at an upper
molar, then activate the exposure time of your X-ray generator unit.
4. Look at the image obtained at your computer screen to verify the spatial and low-contrast
resolutions parameters. Save both the image and the results in your quality control file.
This protocol gives you a complete procedure to verify the quality of your intra-oral digital installation (both
intra-oral sensor and X-ray generator). To conclude that your devices deliver acceptable images, we
recommend you to use the acceptance criteria recommended by the ANSM (French Agency for the Security
of Medical Device – http://ansm.sante.fr/) and published by decree on December, the 26
th
2008 (“Journal
officiel de la République Français” - Text 79/192):
• Images Spatial Resolution for numerical devices: minimum value accepted=5pl/mm (refer to
chapter 5.4.4 of the decree),
• Images Low-Contrast Resolution for numerical devices: minimum value accepted=1mm
(refer to chapter 5.5.3 of the decree).
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7 Specifications
7.1 General specifications
Opteo Sensor - Size 1
External dimensions size 1 sensor 38.6 x 24.7 x 5.2 mm / 1.6 x 1.0 x 0.2 inch
CMOS matrix size 1 sensor (cut corners)
• Sensitive area in size
• Sensitive area in pixels
• Pixel dimensions
30 x 20mm (600mm
2
) / 1.2 x 0.8 inch (1.0 inch
2
)
1500 x 1000 pixels
20 x 20 µm
Opteo Sensor - Size 2
External dimensions size 2 sensor 43.2 x 30.8 x 5.2 mm / 1.7 x 1.2 x 0.2 inch
CMOS matrix size 2 sensor (cut corners)
• Sensitive area in size
• Sensitive area in pixels
• Pixel dimensions
34 x 26 mm (900 mm
2
) / 1.3 x 1.0 inch (1.3 inch
2
)
1700 x 1300 pixels
20 x 20 µm
Technical specifications (size 1 & 2 sensors)
Length sensor cable) 3m / 9.9 ft
Grey levels 14 bits
Connection
USB standard:
USB 2.0 High-Speed (480 Mbit/s) and USB 3.0
Consumption kit 0.5VA under 5V (USB port)
Input voltage sensor
Sensor current absorption
5V (USB port)
0.15A
Operating temperature +10°C to +40°C / 50°F to 104°F
Max Operating Sensor temperature 46 °C for time of contact within 10 minutes
Lifespan CMOS Min. 100,000 cycles
Standards
Conformity to standards
IEC60601-1 3ed (2005)+A1 (2012)
IEC 60601-1-6 3ed (2010)+A1 (2013)
IEC 62304 1ed (2006)+A1 (2015)
IEC60601-1-2 4ed (2014)
CFR21
Medical Device Directive 93/42/EEC (as amended)
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Non clinical testing specifications
Spatial resolution
20pl/mm
Low-Contrast resolution
Minimum value measured: 0.2mm
Dynamic range
14 bits (16384 grey levels).
Sensor saturated at 130ms with no absorbing material (no
object in the X-ray field - X-
ray generator radiological
parameters 7mA/65kV)
Signal to noise ratio Between 33 dB and 4 0dB
Contrast function
0,24 @ 10lp/mm
Image decay and latency
Image is integrated in the sensor for 0,5 second. Image is
read-out just after integration. Image decay and latency don’t
affect the system.
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8 Accessories
Introduction packs of positioners:
7758003400 Size 1
7758003500 Size 2
Refill packs of 10 positioners:
7758012600 Size 1 bitewing (blue)
7758012800 Size 1 endo (pink)
7758012300 Size 1 posterior (green)
7758013000 Size 1 peri-apical (orange)
7758012700 Size 2 bitewing (blue)
7758012900 Size 2 endo (pink)
7758013100 Size 2 posterior (green)
7758013300 Size 2 peri-apical (orange)
7758013400 Aiming ring for positionner
(x5 pcs)
Hygienic single-use disposable protection sleeves (for
size 1 and 2 sensors)
7758003800 Bag of 500 pieces
Mounting accessories
5458000000 Self-adhesive wall support
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