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ENGLISH
Table of Contents
1. Introduction ......................................................................................................... 2
2. Conformity .......................................................................................................... 2
3. General Information ............................................................................................. 2
3.1 About this Document – Symbols .................................................................................... 2
3.2 Legend of Labels and Symbols........................................................................................ 2
4. Description of TRIOS ............................................................................................3
4.1 Certification and Compliance Notes .............................................................................. 3
4.2 Intended Use .................................................................................................................. 3
4.3 Users of the TRIOS MOVE+ ............................................................................................ 3
4.4 Contra-indications ......................................................................................................... 3
4.5 Patient Target Group ...................................................................................................... 3
4.6 Accessory Description ................................................................................................... 3
4.7 TRIOS MOVE+ ................................................................................................................ 3
4.8 Setting up TRIOS MOVE+ ...............................................................................................4
4.9 Starting and Shutting Down the TRIOS MOVE+ .............................................................4
4.10 Starting TRIOS Online Help ..........................................................................................4
4.11 Storage, Operating and Transport Conditions ..............................................................4
4.12 Technical Specifications ................................................................................................4
4.13 Electromagnetic Compability ....................................................................................... 5
4.14 Declaration – Electromagnetic Emissions .................................................................... 5
4.15 Electromagnetic Immunity ........................................................................................... 5
4.16 Distances Between System and Other Equipment ....................................................... 6
5. System Safety ...................................................................................................... 6
5.1 Prerequisites .................................................................................................................... 6
5.2 Potential Mechanical Damages ...................................................................................... 7
5.3 Electrical Safety .............................................................................................................. 7
5.4 Safety when Scanning ..................................................................................................... 7
5.5 Protection from Overheating ......................................................................................... 7
5.6 EMC Safety ..................................................................................................................... 7
5.7 Hygiene .......................................................................................................................... 7
6. Cleaning and Disinfection .................................................................................... 8
6.1 TRIOS MOVE+ Scanner Holder for TRIOS 5: Cleaning and Disinfection .......................... 8
6.2 TRIOS MOVE+ Touch Screen: Cleaning and Disinfection ............................................... 9
7. Disposal ............................................................................................................... 9
8. Technical Maintenance ........................................................................................ 9
9. Cybersecurity ...................................................................................................... 9
10. Vigilance ............................................................................................................ 9
Manufacturer Information
3Shape TRIOS A/S located at Holmens Kanal 7, 1060 Copenhagen, Denmark is legal manufacturer
for devices listed in this guide.
To learn more about 3Shape, our products and global office locations please visit
our website: www.3Shape.com
Declaration of Conformity (EU):
3Shape TRIOS A/S hereby declares that the TRIOS MOVE+ observes the provisions of:
• Medical Device Regulation (EU) 2017/745 (MDR)
• Restriction of Hazardous Substances in Electrical and Electronic Equipment Directive
2011/65/EU (RoHS 2)
• Waste electrical and electronic equipment Directive 2012/19/EU (WEEE)
• Registration, Evaluation, Authorization and Restriction of Chemicals Regulation
1907/2006/EC (REACH)
• Radio Equipment Directive (RED) 2014/53/EU
and is in compliance with the active editions of following standards: EN 60601-1,
EN 60601-1-2, EN 60601-1-6, EN 62471.
3. General Information
IMPORTANT NOTICE
Be sure to observe all warnings!
Please observe all safety information and warnings to prevent personal injury,
material damage or damage to your TRIOS MOVE+. Safety information
and warnings are highlighted in this guide using the words
WARNING
,
CAUTION
or
NOTICE
.
3.1 About this Document – Symbols
WARNING
Warnings regarding situations where a medium risk of injury to persons
exists if the information is not observed.
CAUTION
Information which can affect system functionality if not observed.
IMPORTANT NOTICE
Important information that is not a warning/caution but must be
strictly observed.
3.2 Legend of Labels and Symbols
Date of manufacture
Manufacturer
General warning
WEEE Product disposal
Caution
CE marking applicable for European Union
Serial Number
Alternating Current
Protective earth (ground)
Warning – dangerous voltage
Standby
Refer to instruction manual / booklet. Follow instructions for use
1. Introduction
Dear Customer,
Thank you for purchasing your TRIOS MOVE+ from 3Shape TRIOS A/S.
The TRIOS MOVE+, together with your TRIOS Scanner enables you to obtain oral scans
of patients’ teeth for use in dental CAD/CAM systems.
This TRIOS MOVE+ safety and setup guide describes safety precautions, warnings, and
considerations related to your TRIOS MOVE+. For step-by-step instructions regarding
configuration and operation of the TRIOS System, please refer to the online help.
Before assembling or using your TRIOS MOVE+, carefully read and follow the instructions
in this safety and setup guide and in the online help system.
Keep this safety and setup guide near the TRIOS MOVE+.
Always follow all safety information and warnings to prevent personal injury, material damage
or damage to your TRIOS MOVE+.
Thank you,
3Shape TRIOS A/S
2. Conformity
This guide is published by 3Shape TRIOS A/S, who reserves the right to improve and modify
the contents without prior notice. Modifications will, however, be published in future editions.
All rights reserved.
