MHT 3D Progress Manuale utente

Instructions for use

intraoral scanner

ENGLISH (translation from the original in italian)

97050263

rev. 002

02/2013

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Indice

Table of Contents

Introduction 5

Conventions used in this manual .......................................................................6

General warnings...............................................................................................6

Warning for use..................................................................................................7

Safety and hygiene ............................................................................................8

Maintenance and disposal .................................................................................9

Warranty...........................................................................................................10

Limited responsibility........................................................................................10

Standards and classications ..........................................................................10

Package contents and product parts ...............................................................11

Product identication 13

Intraoral Scanner .............................................................................................14

Power supply ...................................................................................................15

Scannersystemcharacteristics 17

Environmental characteristics ..........................................................................18

Scanner characteristics....................................................................................18

Power supply characteristics ...........................................................................18

Optical characteristics......................................................................................18

Scanner holder.................................................................................................18

USB..................................................................................................................19

Personal computer (optional)...........................................................................19

Cleaninganddisinfection 21

Applying the disposable hygienic protections ..................................................23

Warnings for disposal.......................................................................................24

Preparing for use 25

Using the scanner 29

Troubleshooting 31

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INTRAORAL SCANNER - Instructions for use

Introduction

• Conventions used in this manual

• General warnings

• Warnings for use

• Safety and hygiene

• Maintenance and disposal

• Warranty

• Limited responsibility

• Standards and classications

• Package contents and product parts

6EN

INTRAORAL SCANNER - Instructions for use

Introduction

The intraoral scanner is a portable medical device capable of three-dimensional scanning of dental arches

generating a digital imprint better than a conventional silicon/alginate/hydrocolloid imprint in terms of marks,

precision and accuracy. Thanks to a sophisticated optical system it allows obtaining a digital imprint of:

- stumps (after preparation), single crowns, 3, 4 or 5-element bridges;

- complete dental arches (for orthodontics);

- abutment from scanning for implant repositioning.

Conventions used in this manual

Throughout this manual the term scanner will be used both to identify the handpiece and the 3D scanning sy-

stem as a whole (the product), depending on the context. The following abbreviations are also used:

PC: Personal Computer

3D-Progress: technical product name, also referred to as scanner

MHT: Medical High Technologies S.p.A. a socio unico, Verona (VR), Italy – also referred to as the manufacturer

USB: Universal Serial Bus (data transfer system from devices to PC)

LAN: Local Area Network (PC)

W-LAN: Wireless LAN

General warnings

- The intraoral scanner (system) and the relative software and drivers are developed and manufactured by

MHT, Verona (IT), hereinafter referred to as the manufacturer.

- These instructions describe how to correctly and safely use the scanner. In order to use the scanner sy-

stem, you need image acquisition and storage software. For software installation and use refer to the rela-

tive manual code 97050264. Please carefully read both manuals before starting to use the scanner.

- The purpose of scanning is to acquire and display digital imprints, similar to what was traditionally done with

resin moulds. This operation does not in any way affect the diagnostic examination, which is assumed to

have been carried out at the time the imprint is acquired, nor the subsequent treatment, such as prosthesis

application, implants or orthodontic treatments which are decided and carried out by the orthodontist.

- No part of this publication may be reproduced, stored in a retrieval system, or transmitted in any form or by

any means, electronic, mechanical, photocopying, recording or otherwise, without the prior permission of

the manufacturer.

- MHT pursues a policy of continual improvement of its products, therefore, some specic instructions and

images contained in this manual may differ from the product purchased. MHT reserves the right to make

any modication to this manual without prior notice.

- The information, technical specications and illustrations contained in this publication are not binding. The

manufacturer reserves the right to make technical modications and improvements without modifying the-

se instructions.

- Warning: in observance of the privacy laws in force in numerous countries, suitably protect sensitive per-

sonal data and, moreover, before sending patient images or personal data via computer, informed consent

must be obtained from the patients.

- The original text of this manual is in Italian.

- All the registered trademarks and the product names mentioned are the property of the respective owners.

Please pay particular attention to the sections in the manual where the following symbols appear:

Warnings regarding patient or operator safety.

Warnings regarding the risk of damaging the product, and particularly important warnings regarding

the warranty.

INTRAORAL SCANNER - Instructions for use

Introduction

Warnings for use

- Electronic equipment may cause and suffer from interferences when used in proximity of other electroma-

gnetic equipment, in particular mobile phones, personal computers equipped with W-LAN cards, micro-

wave ovens. Avoid keeping the scanner and the PC intended for acquisition and storage of the scans in

proximity of RF sources, such as W-LAN cards, other radio devices, home RF devices, microwave ovens;

the recommended distance is at least 1 metre and at least 2 metres in the case of microwave ovens.

- It is recommended to install an up-to-date rewall and antivirus protection program on the PC and to use it

exclusively for work purposes.

- In the event of malfunctioning of the PC during an intraoral scan (software or operating system crash or PC

failure) the scan in progress will be interrupted and it might be impossible to retrieve it. Previous scans sa-

ved to the PC (database) will normally not be lost; nevertheless, if the damage to the PC is serious (mainly

to the hard disk or the operating system in general) the scans saved might not be usable or viewable. It is

advisable to regularly make backups of the scans you have made, keeping the backup of the database (or

databases) on the PC up to date on secure and controlled mediums.

- For installation of the other system components (PC network, personal data storage and management

software), it is advisable to contact specialised technicians.

- The USB connection the scanner uses is not a normal electrical connection, but requires specic USB 2.0

cables (recognisable by the marking USB 2.0 Hi-speed, see “Product identication”). The cable is type “A-

B” (provided).

The 3D image acquisition system uses a fragile optical system sensitive to impact. Be very careful

not to drop it during use or when housing it in its seat. Should the optical window break, the device becomes

unusable.

The scanner can pick up relatively weak signals, therefore particularly intense electromagnetic

disturbances may interfere with image acquisition. The scanner transmits the acquired images to the PC in

real-time where they are processed and stored. Therefore, in the event of interferences, just restart the scan-

ner to continue the acquisition without any risk to the patient or the operator, the only disadvantage being that

the procedure will be completed with a few seconds’ delay.

- The power supply and the PC generate heat, therefore, they should be used in a relatively ventilated

position (not closed in a cabinet) ; pay particular attention to the support surface; use only hard and clean

surfaces and avoid carpeting, mats, etc.

- Always use the key switch to turn off the scanner when it is not used and remove the key from the power

supply to prevent unauthorised persons from using the instrument.

- Do not turn off the scanner during scanning; if you need to interrupt work, use the buttons on the scanner

handpiece.

- Never disconnect the scanner cable from the power supply without rst turning it off using the key, as you

risk seriously damaging it.

- The warranty does not cover faults caused by tampering, improper use and evident negligence in use of

the product.

8EN

INTRAORAL SCANNER - Instructions for use

Introduction

Safety and hygene

Warning! The scanner is a medical device for digital acquisition of dental imprints. It may

onlybeusedbyqualiedodontologicalstaff.Donotusethesystemforpurposesotherthanacqui-

sition of endoral scans, and do not use it if you do not have the necessary knowledge in the odon-

tologicaleld.

Warning!Inaccordancewiththe60825-1standards,thedeviceisaproductcontaininganin-

frared laser. Infrared radiation is invisible to the human eye and for this reason might be dangerous.

Scrupulously follow the safety instructions below.

- The instrument does not directly emit a laser beam (even though it contains a laser source). The outer ca-

sing of the instrument blocks light radiation emission, except through the acquisition window. This window

is positioned at the front of the instrument circled red in the image below. Radiation is emitted only during

scanning, i.e. from the moment you press the Start/Stop button to the moment when you press it again; this

will be indicated by a yellow LED on the device keypad coming on.

- Always use safety goggles. Safety goggles must be worn by the operator, the assistant and the patient (and

any other person in the room where the instrument is used) throughout acquisition. The goggles must have

an optical density of at least 1, specically for use with infrared sources (808 nm)

- Performing procedures different from those specied in this manual may cause exposure to dangerous

levels of radiation.

- For any reason do not try to open the scanner casing.

In order to prevent transmission of infectious diseases from patient to patient, it is essen-

tialtoalwaysusethedisposableprotectionsprovided.Thedisposableprotectionsareclassiedas

Class IIa medical device and may not be replaced with others in a lower class. For spare disposable

protections, contact the dealer that supplied the scanner. It is also essential to disinfect the product

as described in the section “Cleaning and disinfection”.

- Cover all the components that will come into contact with the hands of the odontological staff with disposa-

ble protections, as they might be contaminated by indirect contact with the patient’s mouth. In particular, be

careful how you handle the mouse, keypad, PC and scanner handpiece.

INTRAORAL SCANNER - Instructions for use

Introduction

Indice

- Some parts (USB cable, parts of the packaging, power cable) might cause suffocation if ingested or used

improperly. Do not use improperly and keep away from children.

- Not suitable for use in the presence of ammable anaesthetic gas mixed with air, oxygen or nitrous oxide.

- Exclusively use the power supply provided with the device in compliance with the IEC 60601-1 standards.

- Even though the electromagnetic eld irradiated by the instrument is insignicant, it is advisable NOT to use

the product in proximity of life support equipment (e.g. pacemakers or heart stimulators) and hearing aids.

Before using any electronic device in health facilities, always ascertain that it is compatible with the other

equipment present.

- The PC used in connection with the scanner must be in conformity with standards IEC 60601-1, or IEC

60950 with insulation.

- Electric system where the device is installed must be in conformity with IEC 60364-7-710 standards.

Warning!Nopartoftheinstrumentrequiresmaintenancebytheuser.Donotattempt

to access the internal parts of the instrument or the power supply for any reason whatsoever. This

may damage the delicate internal parts and expose you to serious risks (dangerous laser radiation

and dangerous electrical voltage) and will make the warranty null and void.

Maintenance and disposal

- If you nd or suspect any system malfunction, or should the casings be open, do not use the scanner on

a patient and return it to the manufacturer or a Technical Service Centre. The device does not contain any

parts that can be repaired by the user. In the event of a malfunction, do not attempt to carry out maintenan-

ce operations, but directly contact the manufacturer or his local distributor at the numbers indicated in the

warranty certicate. If you need to return the device to the manufacturer or a Technical Service Centre, di-

sinfect all the outer parts of the device using a specic product (see the section “Cleaning and disinfection”)

and preferably return it in its original packaging.

- At the end of its lifetime, dispose of the device in accordance with the regulations in force. Given that there

is a possibility of cross infections, disinfect all the outer parts of the device before disposal and separate the

materials for differentiated waste collection.

- In accordance with Directives 2002/95/EC, 2002/96/EC 2003/108/EC, regarding reduced use of dangerous

substances in electrical and electronic devices as well as waste disposal, do not dispose of the devices in

the household waste but collect them separately. When you purchase a new device of equivalent type, the

device that has come to the end of its lifetime must be returned to the distributor for disposal. As regards

reuse, recycling and other forms of recovery of the above mentioned waste, the manufacturer performs

the functions dened by the individual national legislations. Appropriate differentiated waste collection for

subsequent recycling, treatment and disposal respectful of the environment contributes to preventing pos-

sible negative effects on the environment and health and encourages recycling of the materials of which the

device is made up. The crossed-out bin symbol on the device indicates that the product must be collected

separately from other waste at the end of its useful life. Abusive disposal of the product is liable to a ne as

laid down in the individual national legislations.

10 EN

INTRAORAL SCANNER - Instructions for use

Introduction

Warranty

The manufacturer guarantees the safety, reliability and performance of the devices. The warranty is conditional

on compliance with the following rules:

- Observance of the conditions stated on the warrantycerticate.

The device must be used exclusively in accordance with the instructions given in this instruction manual.

Installation, repairs, calibration and in general all the operations that require opening the device covers must

be carried out exclusively by technicians authorised by the manufacturer.

WARNING! The manufacturer declines all responsibility for damage to persons and things

if failing to observe this clause.

Limited responsability

Under no circumstances will the manufacturer or its suppliers be responsible for direct or indirect damage

(including damage for loss or failed earnings or savings, interruption of the activity, loss of information or data

and other economic losses) to the user or third parties deriving from use or failed use of the software, even if

the manufacturer has been notied of the possibility of such damage.

This limit of responsibility is applicable not only in cases where the software is not used according to the pro-

cedures indicated by the manufacturer, but also if the software is used in accordance with the instructions.

Standards and classications

The scanner is an optical system for three-dimensional scanning of dental arches classied in Class I in ac-

cordance with the CEI EN 60601-1 standards and Class IIa in accordance with the Medical Device Directive.

The scanner and its accessories have been designed and constructed in conformity with the following stan-

dards:

93/42/EEC and

subsequent amendments

Medical Device Directive.

IEC 60601-1 General requirements for safety of electromedical devices. Device

designed to operate in the climatic conditions typically found in clo-

sed working environments in compliance with this standard.

IEC 60601-1-2 Electromedical devices: Electromagnetic compatibility – Require-

ments and tests.

IEC 60878 Graphic symbols for electromedical device functions.

UNI CEI EN ISO 14971 Medical devices – Application of risk management to medical devi-

ces.

IEC 60825-1 Safety of laser devices – Device classication and safety require-

ments.

Class IIa medical device in accordance with Directive 93/42/EEC and subsequent amendments.

Class 1 device with applied part type B in accordance with IEC 60601-1.

Class 3R invisible laser source in accordance with IEC 60825-1.

Neither the scanner (handpiece) nor the power supply are protected against penetration of liquids (IPX0 de-

gree of protection).

Not suitable for use in the presence of ammable anaesthetic gas mixed with air, oxygen or nitrous oxide.

The device is suitable for continuous operation.

In compliance with the European and American regulations for electrical safety and electromagnetic interfe-

rences; therefore, it does not generate dangerous electromagnetic interferences and is not disturbed by the

Indice

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