Owandy One Bedienungsanleitung

EN •INSTALLATION AND USER MANUAL

7758014200 • Version 05, 2 July 2019

 EN 
 
ONE –User manual Page 3/44 
 
Index 
1INTRODUCTION...............................................................................................................................................5 
1 INTENDED USE ....................................................................................................................................................... 5 
2 INTENDED PATIENT POPULATION................................................................................................................................ 5 
3 APPLICATION ENVIRONMENTS ................................................................................................................................... 6 
4 APPLIED PARTS....................................................................................................................................................... 6 
5 FREQUENCY OF USE................................................................................................................................................. 6 
6 PRESCRIPTION USE STATEMENT................................................................................................................................. 6 
7 COMPLIANCE WITH STANDARDS................................................................................................................................. 6 
8 POWER SUPPLY ...................................................................................................................................................... 6 
9 INSTALLATION PRECAUTIONS..................................................................................................................................... 7 
10 LIABILITY AND OPERATORS........................................................................................................................................ 7 
11 PACKAGING AND ENVIRONMENT................................................................................................................................ 8 
12 MARKING AND LABELLING SYMBOLS ........................................................................................................................... 8 
13 ELECTROMAGNETIC INFORMATION............................................................................................................................. 9 
14 ELECTROMAGNETIC EMISSIONS................................................................................................................................ 10 
15 ELECTROMAGNETIC IMMUNITY................................................................................................................................ 11 
16 ENVIRONMENTAL RISKS AND DISPLACEMENT .............................................................................................................. 12 
17 MANUFACTURER IDENTIFICATION ............................................................................................................................ 12 
18 IDENTIFICATION LABEL ........................................................................................................................................... 13 
2CONTENTS.....................................................................................................................................................14 
3INSTALLATION............................................................................................................................................... 14 
1 PRECAUTIONS...................................................................................................................................................... 14 
2 EQUIPMENT INSTALLATION ..................................................................................................................................... 16 
3 SOFTWARE INSTALLATION....................................................................................................................................... 17 
4 CONFIGURATION IN THE OWANDY IMAGING SOFTWARE ............................................................................................... 21 
5 SHARING THE SENSOR AND BOX BETWEEN DIFFERENT WORKSTATIONS............................................................................. 23 
4USE................................................................................................................................................................24 
1 PRECAUTIONS...................................................................................................................................................... 24 
2 SENSOR PRINCIPLES............................................................................................................................................... 25 
3 USE OF THE OWANDY XIO STANDALONE SOFTWARE................................................................................................... 26 
4 ACQUISITION OF AN IMAGE..................................................................................................................................... 29 
5 EXPOSURE TIMES.................................................................................................................................................. 31 
5HYGIENE AND MAINTENANCE.......................................................................................................................32 
1 HYGIENE AND DISINFECTION ................................................................................................................................... 32 
2 RECOMMENDED CLEANING AND DECONTAMINATION PROCEDURE .................................................................................. 33 
3 MAINTENANCE..................................................................................................................................................... 34 
6TROUBLESHOOTING AND TESTS METHOD.....................................................................................................35 
1 GENERAL ............................................................................................................................................................ 35 
2 IMAGE QUALITY.................................................................................................................................................... 35 
3 TESTS METHOD.................................................................................................................................................... 37 
7SPECIFICATIONS ............................................................................................................................................ 39 
1 GENERAL SPECIFICATIONS....................................................................................................................................... 39 
8ACCESSORIES.................................................................................................................................................42 

ONE –User manual Page 4/44

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 : +33 1.64.11.18.18

Fax : +33 1.64.11.18.10

ONE –User manual Page 5/44

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

ONE –User manual Page 6/44

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

ONE –User manual Page 7/44

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).

ONE –User manual Page 8/44

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.

ONE –User manual Page 9/44

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.

ONE –User manual Page 10/44

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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