Acteon X-MIND trium Manual de usuario

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USER MANUAL

USER MANUAL• X-Mind trium • (13) • 03/2018 • NTR0EN010M

ENGLISH

MANUFACTURER

de Götzen®S.r.l. - a company of ACTEON Group

Via Roma, 45

21057 OLGIATE OLONA (VA) – ITALY

Tel. +39 0331 376760

Fax +39 0331 376763

www.acteongroup.com

FOR INFORMATION AND TECHNICAL ASSISTANCE, CONTACT YOUR LOCAL ACTEON

AUSTRALIA

NEW ZEALAND

AUTHORIZED SPONSOR

ACTEON AUTRALIA/NEW ZEALAND

[email protected]

CANADA REGULATORY CORRISPONDENT

ACTEON INC

[email protected]

CHINA ACTEON CHINA

[email protected]

FRANCE SOPRO - ACTEON GROUP

[email protected]

GERMANY ACTEON GERMANY

[email protected]

INDIA ACTEON INDIA

[email protected]

ITALY ACTEON ITALIA

[email protected]

JAPAN MHA Market Authorization Holder

Hakusui Trading Co., Ltd.

MIDDLE EAST ACTEON MIDDLE EAST

[email protected]

RUSSIA ACTEON RUSSIA

[email protected]

SPAIN ACTEON MEDICO-DENTAL IBERICA

[email protected]

SOUTH AMERICA ACTEON LATIN AMERICA

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TAIWAN ACTEON TAIWAN

[email protected]

THAILAND ACTEON THAILAND

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U.K. ACTEON UK

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USA INITIAL IMPORTER / US AGENT

ACTEON INC

[email protected]

OR THE MANUFACTURER AT

[email protected]

ENGLISH

USER MANUAL• X-Mind trium • (13) • 03/2018 • NTR0EN010M

Language of the original document: ENGLISH

Important: All new editions and revisions of the manuals supersede the previous ones

Refer to complete manuals and

instructions For complete manuals

and instructions

www.acteongroup.com

Scan the QR code to access the

dedicated website

www.acteongroup.com

USER MANUAL• X-Mind trium • (13) • 03/2018 • NTR0EN010M

ENGLISH

CONTENTS

INTRODUCTION-----------------------------------------------------------------------------------------------6

1.1 CAUTIONS----------------------------------------------------------------------------------------------------------------------------------- 6

1.3 IDENTIFICATION TAGS ---------------------------------------------------------------------------------------------------------------- 8

1.4 POSITION OF THE IDENTIFICATION LABELS -------------------------------------------------------------------------------11

1.5 STANDARDIZED SYMBOLS------------------------------------------------------------------------------------------------ 12

DESCRIPTION------------------------------------------------------------------------------------------------- 13

2.1 OPERATOR’S WORKSTATION ------------------------------------------------------------------------------------------------------13

2.2 X-MIND TRIUM REMOTE CONTROL ---------------------------------------------------------------------------------------------13

2.3 X-MIND TRIUM MEDICAL DEVICE------------------------------------------------------------------------------------------------14

2.4 X-MIND TRIUM CONFIGURATIONS ---------------------------------------------------------------------------------------------16

2.5 EXAMS ---------------------------------------------------------------------------------------------------------------------------------------16

2.6 CONTROL PANELS ---------------------------------------------------------------------------------------------------------------------18

2.7 KEYS DESCRIPTION---------------------------------------------------------------------------------------------------------------------19

2.8 LIGHT INDICATORS --------------------------------------------------------------------------------------------------------------------20

2.9 X-MIND TRIUM REMOTE CONTROL ---------------------------------------------------------------------------------------------20

2.10 EMERGENCY SWITCHES-------------------------------------------------------------------------------------------------------------21

2.11 X-RAY EXPOSURE SWITCH ---------------------------------------------------------------------------------------------------------22

2.12 HEAD SUPPORT FOR PAN/CBCT EXAMS -------------------------------------------------------------------------------------22

2.13 HEAD SUPPORT FOR CEPH EXAMS ---------------------------------------------------------------------------------------------22

2.14 ACCESSORIES ---------------------------------------------------------------------------------------------------------------------------23

SWITCHING ON / OFF THE SYSTEM -----------------------------------------------------------------25

3.1 SWITCHING ON--------------------------------------------------------------------------------------------------------------------------25

3.2 SWITCHING OFF -------------------------------------------------------------------------------------------------------------------------26

PRE ACQUISITION ------------------------------------------------------------------------------------------27

4.1 PREPARING THE SYSTEM-------------------------------------------------------------------------------------------------------------27

4.2 CREATING OR SELECTING PATIENT DATA-------------------------------------------------------------------------------------27

4.3 INSTRUCTING THE PATIENT -------------------------------------------------------------------------------------------------------27

4.4 POSITIONING THE PATIENT FOR PAN/CBCT EXAMS ---------------------------------------------------------------------28

PAN ACQUISITION -----------------------------------------------------------------------------------------30

5.1 SELECTING THE EXAM TYPE --------------------------------------------------------------------------------------------------------30

5.2 PATIENT POSITIONING---------------------------------------------------------------------------------------------------------------31

5.3 EXECUTION OF THE PAN EXAM ---------------------------------------------------------------------------------------------------33

CBCT ACQUISITION----------------------------------------------------------------------------------------34

6.1 SELECTING THE EXAM TYPE --------------------------------------------------------------------------------------------------------34

6.2 PATIENT POSITIONING---------------------------------------------------------------------------------------------------------------37

6.3 EXECUTION OF THE CBCT EXAM--------------------------------------------------------------------------------------------------38

CEPH ACQUISITION---------------------------------------------------------------------------------------- 40

7.1 SELECTING THE EXAM TYPE --------------------------------------------------------------------------------------------------------40

7.2 PATIENT POSITIONING---------------------------------------------------------------------------------------------------------------40

7.3 EXECUTION OF THE CEPH EXAM--------------------------------------------------------------------------------------------------42

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RELEASING THE PATIENT--------------------------------------------------------------------------------43

MAINTENANCE, CLEANING AND DISPOSAL----------------------------------------------------- 44

9.1 MAINTENANCE --------------------------------------------------------------------------------------------------------------------------44

9.2 CLEANING----------------------------------------------------------------------------------------------------------------------------------44

9.3 DISPOSAL-----------------------------------------------------------------------------------------------------------------------------------44

TROUBLESHOOTING --------------------------------------------------------------------------------------45

10.1 ERROR CODES AND REQUIRED ACTIONS------------------------------------------------------------------------------------45

10.2 TRIUM ERRORS-------------------------------------------------------------------------------------------------------------------------46

ANNEXES -------------------------------------------------------------------------------------------------------55

11.1 DEVICE POWER SUPPLY-------------------------------------------------------------------------------------------------------------55

11.2 ELECTRICAL CLASSIFICATION (IEC 60601-1) -------------------------------------------------------------------------------55

11.3 X-RAY ASSEMBLY AND X-RAY TUBE--------------------------------------------------------------------------------------------55

11.4 DEGREE OF PROTECTION PROVIDED BY ENCLOSURES ---------------------------------------------------------------57

11.5 DEVICE MECHANICAL DATA ------------------------------------------------------------------------------------------------------58

11.6 WORKSTATION FEATURES ---------------------------------------------------------------------------------------------------------58

11.7 DETECTORS ------------------------------------------------------------------------------------------------------------------------------58

11.8 SCANNING PARAMETERS – PAN/CEPH ---------------------------------------------------------------------------------------59

11.9 SCANNING PARAMETERS – CBCT -----------------------------------------------------------------------------------------------59

11.10 LASER ------------------------------------------------------------------------------------------------------------------------------------60

11.11 FIRMWARE DATA --------------------------------------------------------------------------------------------------------------------60

11.12 CLIENT PC MINIMUM REQUIREMENTS ------------------------------------------------------------------------------------60

11.13 INTENDED ENVIRONMENT------------------------------------------------------------------------------------------------------61

11.14 DIMENSIONS OF THE UNIT -----------------------------------------------------------------------------------------------------61

11.15 LIST OF INTERNATIONAL STANDARDS AND DIRECTIVES ----------------------------------------------------------63

11.16 DOSIMETRIC INDICATIONS -----------------------------------------------------------------------------------------------------63

11.16.2 DOSIMETRIC INDICATIONS IN TERMS OF CTDI (FOR CBCT EXAMS) ------------------------------------------------------------- 74

11.17 ELECTROMAGNETIC COMPATIBILITY ---------------------------------------------------------------------------------------82

11.17.1 RECOMMENDED SEPARATION DISTANCES------------------------------------------------------------------------------------------------ 82

11.17.2 ELECTROMAGNETIC EMISSIONS-------------------------------------------------------------------------------------------------------------- 82

11.17.3 ELECTROMAGNETIC IMMUNITY--------------------------------------------------------------------------------------------------------------- 83

11.17.4 ELECTROMAGNETIC IMMUNITY, HANDHELD RADIOFREQUENCY EQUIPMENT --------------------------------------------- 84

WARNINGS ----------------------------------------------------------------------------------------------------85

INTERACTIONS CONTRAINDICATIONS PROHIBITIONS------------------------------------ 88

USER MANUAL• X-Mind trium • (13) • 03/2018 • NTR0EN010M

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INTRODUCTION

Thank you for choosing the X-MIND trium.

The electro medical equipment described in this manual refers to the X-Mind trium medical device.

X-MIND trium is a radiological device and must be used and handled only by specialised surgeons, dentists and authorised

and duly trained personnel, who meet the requirements provided by the national laws in force in the country of installation.

The training and preparation of personnel must be included in the tasks of the responsible organization.

Before using the X-MIND trium, the operator must read and understand all the instructions provided in the manual in order to

obtain the highest performance and ensure the safety of patients, of operators, of the medical device and the environment.

X-MIND trium is a digital panoramic, cephalometric and tomographic extra-oral X-ray system, indicated for use in:

- producing panoramic X-ray images for diagnostic examination of dentition (teeth), jaws and oral structures;

- producing radiographs of maxillofacial region and parts of the skull for cephalometric examination, if equipped with CEPH

arm;

- producing radiographs of hands and wrists for carpus examination, if equipped with CEPH arm;

- producing tomographic images of the oral and maxillofacial region, for diagnostic examination of dentition (teeth), jaws,

oral structures and some cranial bones, if equipped with CBCT option.

This medical device complies with the essential requirements of European Directive 93/42/EEC. This equipment is

designed and developed in compliance with Electrical Safety standard IEC 60601-1 in force. It was designed and

manufactured in accordance with an EN ISO 13485-certied quality assurance system and Good Manufacturing

Practices (21 CFR 820).

From a clinical point of view, the X-MIND trium can be applied for the following medical applications:

• Generic dentistry

• Dental implantology

• Dental surgery

• Maxillo-facial surgery

• Cephalometric analysis

• Carpus radiology

The target patient population includes adults and pediatric patients from 5 years old [~21 kg (46 lb); 113 cm (44.5 in) standing

height]; anyway the sustainability to X-ray exposure must be evaluated by surgeons, dentists and qualied and authorized

physicians.

The intended user prole is a qualied, trained and authorized physician or dentist who meets the requirements provided

by national laws in force in the country of installation; the operator must understand the language of the country where the

device is installed.

Contraindications:

● Viewing cartilaginous structures;

● The CBCT technique has a limited capability of detecting soft tissues.

1.1 CAUTIONS

CAUTION :

CAUTION messages refer to circumstances that can jeopardise the operator’s safety, cause injuries to operators and patients or

damage the medical device and the environment.

WARNING :

WARNING messages refer to circumstances that can compromise the performance of the X-MIND trium medical device.

NOTE :

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USER MANUAL• X-Mind trium • (13) • 03/2018 • NTR0EN010M

NOTE messages provide indications for easier maintenance and highlight important information.

1.1 MANUFACTURER RESPONSIBILITY

The manufacturer shall under no circumstances be held liable for injuries to persons or damage to property

caused by:

• Non-compliance with manufacturer recommendations during installation, whether this is the network voltage

or the electromagnetic environment,

• Maintenance or repair procedures performed by people who are unauthorized by the manufacturer,

• Use on an electrical xture that is not compliant with regulations in force,

• Uses other than those specied in this manual.

• Use of accessories (temple rest, chin rest, bites, etc.) other than those supplied by ACTEON Imaging,

• Use of hygienic protections different from class I Medical Device Directive 93/42/EEC and subsequent

amendments or not compliant with ISO 10993 series of standards.

• Non-compliance with the instructions contained in the accompanying documents.

Note: the manufacturer reserves the right to modify the medical device and/or any documentation without

notice.

1.2 WARRANTY

Any improper use or unauthorised modication to the medical device shall relieve the manufacturer of the

medical device, from the obligation to provide assistance covered by warranty and from any liability. This will

also result in additional charges for technical assistance not covered by warranty.

The warranty is valid only if the following requirements are complied with:

• Repairs, modications, adjustments and calibrations must be carried out solely by ACTEON Group or by qualied,

authorised and/or trained personnel.

• Installation must be carried out by qualied and trained technicians in compliance with the standards in force

and as recommend by the manufacturer.

• This medical device must be installed and used following the instructions provided in the installation manual

and in the attached documents.

• The mains power supply must provide the required power and its characteristics must meet the specications

indicated on the medical device identication label.

• The medical device must be periodically inspected by qualied, authorized and trained technical personnel in

compliance with the standards in force and with the manuals provided by the manufacturer.

USER MANUAL• X-Mind trium • (13) • 03/2018 • NTR0EN010M

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Terminology used in the manual:

TERM MEANING

AOR Axis Of Rotation. Axis of rotation of the U-Arm.

CBCT Medical device that acquires radiological images, using a cone radiation beam and reconstructs the 3D volume

of the scan.

CEPH Is the common name for Cephalometry or Cephalostat.

DGI Proprietary le format used to save digital radiological projections.

DICOM Digital Imaging and Communications in Medicine. Medical imaging standard that denes the rules and criteria

to transfer, view, store and print information in medical imaging, in order to ensure communication between

medical devices and information systems.

FOV Field Of View. The volume scanned and reconstructed by the X-MIND trium medical device.

FPD Flat Panel Detector. 2-dimensional digital detector to acquire radiographic projections.

PAN Is the common name for panoramic image or Orthopantomogram.

ROI Region of Interest. Patient’s anatomical area to be examined and segmented in a tomographic image.

HU Hounseld Unit. Standard reference scale used to describe radiodensity in systems.

AIS Acteon imaging Suite software that manages all the functional aspects of the X-MIND trium system, including:

patient database, patient acquisition, calibrations, quality tests, maintenance, display that allows the operator

to make the diagnosis and treatment planning.

1.3 IDENTIFICATION TAGS

X-MIND TRIUM LABEL

X-RAY ASSEMBLY label

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USER MANUAL• X-Mind trium • (13) • 03/2018 • NTR0EN010M

X-RAY BEAM LIMITER label

CAUTION X-RAYS LABEL

CAUTION LASER BEAM LABEL FRANKFURT LASER APERTURE

Please see section 11.11 for more details

X-MIND trium is a class 3R laser product. Avoid direct eye exposure to laser radiation. Viewing the laser

output with telescopic optical instruments (for example, telescopes and binoculars) may pose an eye

hazard and thus the user should not direct the beam into an area where such instruments are likely to be

used

Use of controls or adjustments or performance of procedures other than those specied herein may

result in hazardous radiation exposure

PAN DETECTOR LABEL

USER MANUAL• X-Mind trium • (13) • 03/2018 • NTR0EN010M

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REMOVABLE DETECTOR LABEL

3D DETECTOR LABEL

CEPH ARM LABEL

ETL MARKING

UDI LABEL

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