Owandy One User manual

EN •INSTALLATION AND USER MANUAL
7758014200 • Version 05, 2 July 2019

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Index
1INTRODUCTION...............................................................................................................................................5
1.1 INTENDED USE ....................................................................................................................................................... 5
1.2 INTENDED PATIENT POPULATION................................................................................................................................ 5
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 ...................................................................................................................................................... 6
1.9 INSTALLATION PRECAUTIONS..................................................................................................................................... 7
1.10 LIABILITY AND OPERATORS........................................................................................................................................ 7
1.11 PACKAGING AND ENVIRONMENT................................................................................................................................ 8
1.12 MARKING AND LABELLING SYMBOLS ........................................................................................................................... 8
1.13 ELECTROMAGNETIC INFORMATION............................................................................................................................. 9
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
2CONTENTS.....................................................................................................................................................14
3INSTALLATION............................................................................................................................................... 14
3.1 PRECAUTIONS...................................................................................................................................................... 14
3.2 EQUIPMENT INSTALLATION ..................................................................................................................................... 16
3.3 SOFTWARE INSTALLATION....................................................................................................................................... 17
3.4 CONFIGURATION IN THE OWANDY IMAGING SOFTWARE ............................................................................................... 21
3.5 SHARING THE SENSOR AND BOX BETWEEN DIFFERENT WORKSTATIONS............................................................................. 23
4USE................................................................................................................................................................24
4.1 PRECAUTIONS...................................................................................................................................................... 24
4.2 SENSOR PRINCIPLES............................................................................................................................................... 25
4.3 USE OF THE OWANDY XIO STANDALONE SOFTWARE................................................................................................... 26
4.4 ACQUISITION OF AN IMAGE..................................................................................................................................... 29
4.5 EXPOSURE TIMES.................................................................................................................................................. 31
5HYGIENE AND MAINTENANCE.......................................................................................................................32
5.1 HYGIENE AND DISINFECTION ................................................................................................................................... 32
5.2 RECOMMENDED CLEANING AND DECONTAMINATION PROCEDURE .................................................................................. 33
5.3 MAINTENANCE..................................................................................................................................................... 34
6TROUBLESHOOTING AND TESTS METHOD.....................................................................................................35
6.1 GENERAL ............................................................................................................................................................ 35
6.2 IMAGE QUALITY.................................................................................................................................................... 35
6.3 TESTS METHOD.................................................................................................................................................... 37
7SPECIFICATIONS ............................................................................................................................................ 39
7.1 GENERAL SPECIFICATIONS....................................................................................................................................... 39
8ACCESSORIES.................................................................................................................................................42

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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: 2013
OWANDY RADIOLOGY
2, rue des Vieilles Vignes
77183 Croissy-Beaubourg
FRANCE
Telephone : [phone]
Fax : [phone]

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1Introduction
You have just received your ONE 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
ONE 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.
ONE is used for diagnosis purpose by dental practitioners or radiologists.
1.2 Intended patient population
One 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

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1.3 Application environments
One kit may be used in dental practice environment.
One may be used in professional buildings or in 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, One 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 ONE kit is class IIa equipment within the meaning of the European Directive 93/42/CEE concerning CE markings.
The ONE 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 ONE kit and the X-ray generator.
1.8 Power supply
The power to the ONE box is provided directly by the power supply of the USB cable connecting it to the computer. For the
procedure for switching the device ON and OFF refer to the computer instructions

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1.9 Installation precautions
Warning
The computer connected to the sensor MUST necessarily comply with standard IEC 60950-1.
.
Warning
The One 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 One 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 ONE 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 +35°C / 50°F to 95 °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.
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.

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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
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
One should not be used adjacent to or stacked with other equipment; if adjacent use is necessary, One
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 One
including cable. Minimum distance 30 cm.

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1.14 Electromagnetic emissions
In accordance with IEC 60601-1-2 4th edition standard, One 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
One is suitable for use in the specified electromagnetic environment. The purchaser or user of the One should assure that it is
used in an electromagnetic environment as described below:
Emissions test
Compliance
Electromagnetic Environment
RF emissions
CISPR 11
Group 1
One uses RF energy only for its internal function. Therefore, the RF emission
is very low and not likely to cause any interference in nearby electronic
equipment.
RF emissions
CISPR 11
Class B
One is suitable for use in all establishments, including domestic
establishments and those directly connected to the public low-voltage
power supply network that supplies buildings used for 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 4th edition standard One 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 One 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 One, 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 One
requires continued operation during
power mains interruptions, it is
recommended that the One 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
One sensor size 1 identification label
One sensor size 2 identification label

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2Contents
Your ONE kit consists of the following elements (illustrations may vary from items supplied):
An ONE 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
3INSTALLATION
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.

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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 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 7, 8, 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
1 GB
High resolution 1024x768 (15inch)
RAM memory
Hard disk
2 GB
500 GB
CD-ROM drive
Backup system
24x
External/removable disk,
CD-ROM/DVD…
Printer
Keyboard and mouse
Laser, inkjet, thermal
Warning
The computer connected to the sensor MUST be compliant with standard IEC 60950-1.
If your computer does not possess USB 2.0 ports, these can be added as PCI/PCI express cards (for desktop
computers) or PCMCIA cards (for laptops). The PCMCIA cards need to be powered by an external power supply if
they do not provide enough current. Please contact your IT specialist for further information.
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.

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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 ONE 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.
3.3.1 Installation of OSP and drivers
Warning
The ONE drivers are only compatible with Windows 7 (32 and 64 bits), Windows 8 (32 and 64 bits) and
Windows 10 (32 and 64 bits) operating systems.
Automatic installation:
1. Connect QuickVision USB stick to the PC. Open setup partition and launch “autorun.exe”. In the following window
click on One box

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2. Select the language and click on next
3. Follow the instruction: click on next

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then click on install and window below is displayed
4. Plug in the detector in the USB port and click on install

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5. Select install driver Sofware
6. wait for the following window
7. click ok and click finish
8. close the menu