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