MHT 3D Progress User manual

IT
Instructions for use
intraoral scanner
ENGLISH (translation from the original in italian)
EN
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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5
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INTRAORAL SCANNER - Instructions for use
1
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
1
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.

7
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INTRAORAL SCANNER - Instructions for use
Introduction
1
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.

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INTRAORAL SCANNER - Instructions for use
Introduction
1
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.

9
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INTRAORAL SCANNER - Instructions for use
Introduction
1
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.

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INTRAORAL SCANNER - Instructions for use
Introduction
1
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

11
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INTRAORAL SCANNER - Instructions for use
Introduction
1
emissions generated during operation of other devices.
Package contents and product parts
WARNING: The package is made up in stacked layers. Check that you have taken out all the
components before disposing of the packaging.
Intraoral scanner.
Power supply for intraoral scanner.
Scanner holder.
CD-ROM with software and drivers.
USB 2.0 Hi-Speed® cable.
Package of disposable hygienic protections.
Warranty certicate.
Declaration of conformity.
Mains power cable (according to the destination country).

12 EN
INTRAORAL SCANNER - Instructions for use
Introduction
1Component parts of the medical device:
- Scanner handpiece;
- Power supply interface;
- Reconstruction software.
Accessories supplied with the product that do not form part of the medical device:
- Power connection cable;
- USB cable;
- An adequate rst supply of disposable hygienic protections;
- A tabletop handpiece holder.
External parts required for the system as a whole that do not are part of the medical device and are
not provided with the product:
- Personal computer.

13
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INTRAORAL SCANNER - Instructions for use
2
Product
identication
• Intraoral scanner
• Power supply

14 EN
INTRAORAL SCANNER - Instructions for use
Identication
2Intraoral scanner
The light radiation (laser) output window is indicated on the front of the handpiece (marking as an alternative).
The product identication symbols are indicated on the lower part of the scanner:
xxxx xxxx Product identication serial number.
Symbol: applied part type B.
Symbol: dispose of the product in compliance with Directive 2002/96/EC.

15
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INTRAORAL SCANNER - Instructions for use
Identication
2
Power supply
- The power supply is equipped with a key control to prevent unauthorised persons from using the instru-
ment.
- Exclusively use the power supply provided with the product.
The product identication symbols are indicated on the lower part of the scanner power supply interface:
MHT SPA a socio unico, Via E. Fermi
22, 37135 Verona - ITALY Name of the manufacturer and place of manufacture.
3D PROGRESS Industrial product name.
Made in Italy Country of manufacture.
Input: 100-240V 50/60 Hz 1.1-1.8A Operating voltage and frequency and current absorbed.
Output: 12V 8.0 A Output voltage and current (handpiece power supply).
Warning: read the instruction manual.
Device in compliance with the requirements laid down in Directive
93/42/EEC and subsequent amendments.
SN xxxxxxx Serial number .
Date of manufacture (month/year).
The following is indicated on the front of the power supply:
Identication of the handpiece connector .

16 EN
INTRAORAL SCANNER - Instructions for use
Identication
2Identication of the connector for the USB cable to be connected to the PC.
Warning: read the instruction manual.
Key switch open.
Key switch closed.
Label with safety indications relating to the radiation emitted by the handpie-
ce in compliance with IEC 60825-1.
”Danger! Laser” label in conformity with IEC 60825-1.
The power connections are found on the rear of the power supply:
POWER
Connection for a power cable in compliance with IEC320-C13.
For Europe: the cable must be in compliance with IEC 60601-1.
For USA/Canada: the cable must be in compliance with CSA22.2 no.601.1-M90 +
UL60601-1.
O I Main power switch.
2 FUSES x T 2A Main fuse identication: if necessary, replace the fuses only with ones of the same type.
The USB cable is marked with the following symbols:
USB connection.
Cable in compliance with USB 2.0 Hi-Speed standard.

17
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INTRAORAL SCANNER - Instructions for use
3
Scanner system
characteristics
• Environmental characteristics
• Scanner characteristics
• Power supply characteristics
• Optical characteristics
• Scanner holder
• USB
• Personal computer (optional)

18 EN
INTRAORAL SCANNER - Instructions for use
Characteristics
3
The scanner has been designed to operate in the climatic conditions typically found in closed working envi-
ronments in compliance with the IEC 60601-1 standards.
Environmental characteristics
Operation:
- temperature +10°C ÷ +35°C;
- RH humidity between 20% and 90%;
- Atmospheric pressure 500 ÷ 1060 hPa;
Storage:
- Temperature -10 °C ÷ +50 °C;
- RH humidity between 0% and 100%;
- Atmospheric pressure 500 ÷ 1060 hPa.
Scanner characteristics
- Power supply: by means of the specic power supply provided, 12VDC, max. 8A.
- Dimensions: 295 x 45 x55mm (LxHxW).
- Weight: 720g excluding cable.
- USB: USB 2.0 High Speed.
- Native image: three-dimensional cloud of points.
- Export format: STL le.
- Optical window temperature (anti-misting): 42°C ± 2°C.
- Combined confocal microscopy with Moiré effect recognition.
- SmartPixel sensor.
- Special aspheric lenses.
- Single-frame acquisition time less than 1/10 of a second.
- Typical scanning speed: 14 scans/second.
- Real Time Stitching of the individual frames.
- Resolution (pixel) on the sensor: 144 x 90.
- Pixel size: 50 x 86μm.
- Resolution on the object (XxY): 66μm x 120μm.
- Scanning area (on the object-XxYxZ): 9.6 mm x 10.4 mm x 18 mm.
Power supply characteristics
- Specically for the intraoral scanner, it includes a power supply and USB interface.
- Mains voltage and current: universal power supply, 100-240 VAC, 50/60 Hz, 1.1-1.8 A.
- Output voltage and current: 12VDC -8.0 A
- Power cable type IEC320-C13 with plug according to the destination country.
- Weight: 1200 g.
- USB: USB 2.0 High Speed.
Optical characteristics
- Invisible laser source in accordance with IEC 60825-1: class 3R.
- Power output: < 90mW.
- Emitted radiation wavelength: 808 nm.
- Protective goggles: Minimum optical density (OD) 1.
- Continuous emission during scanning.
- Beam with divergence (semi-angle) of 15°.
Scanner holder
The tabletop holder provided is useful to put the scanner handpiece on when it is not operating. The holder
must be positioned on a stable horizontal surface that guarantees safety against accidental dropping of the
scanner.

19
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INTRAORAL SCANNER - Instructions for use
Characteristics
3
USB
- Standard USB cable type “B” - “A”.
- In compliance with the standard: USB 2.0 HIGH SPEED.
- Maximum length (without line amplier hub): 4.5 metres.
Personal computer (optional)
For the minimum requirements of the PC and the relative operating system, refer to the software manual code
97050264.

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