3Shape TRIOS S1P-2 - Table of Contents; Dear Customer; Conformity; General Information

2
ENGLISH
Table of Contents
1. Dear Customer
Thank you forpurchasing your TRIOS
®
intraoral scanner (IOS)
system from 3Shape TRIOSA/S.
TheTRIOS IOS system enables you toperform anddigitally save oral scans
ofpatient’s teeth foruse indental CAD/CAM systems.
ThisTRIOS safety andsetup guide describes safety precautions, warnings,
andconsiderations related toyour TRIOS IOS system. Forstep-by-step
instructions regarding configurationandoperation ofTRIOS, please refer
totheonline help.
Before assembling orusing TRIOS IOS system, please carefully read andfollow
theinstructions inthissafety andsetup guide andintheonline help system.
Pleasealways keep thissafety andsetup guide near thesystem.
Please observe all safety informationandwarnings toprevent personal injury,
material damage ordamage toyour TRIOS IOS system.
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.
TRIOS isatrademark of3Shape TRIOSA/S.
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
If you would like to receive a free printed copy please contact 3Shape
support via email, support@3shape.com.
DeclarationofConformity (EU):
3Shape TRIOS A/S hereby declares that the TRIOS 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),
• Waste Electrical and Electronic Equipment Directive
2012/19/EU (WEEE),
• Registration, Evaluation, Authorization and Restriction
of Chemicals Regulation 1907/2006/EC (REACH)
and is in compliance with the following standards: EN (IEC)
60601-1, EN (IEC) 60601-1-2, EN (IEC) 60601-1-6, EN (IEC) 62471.
3. General Information
CAUTION
Be sure to observe all warnings!
Please observe all safety information and warnings
to prevent personal injury, material damage or damage
to your TRIOS IOS system. Safety information and warnings
are highlighted in this guide using the words WARNING,
CAUTION or IMPORTANT NOTICE.
3.1 About this Document – Symbols
The symbols used in this document imply the following:
WARNING
Warnings regarding situations where a medium risk
of injury to persons exists if the information s not observed.
(Black on yellow)
CAUTION
Safety information where hazards such as slight risk
of injury to persons, risk of property damage or damage
to the system exist if the information is not observed.
IMPORTANT NOTICE
Important information that is not a warning/caution
but must be strictly observed.
TIPS
Hints, tips, additional information to support optimal
operation of the system.
3.2 Legend of Labels and symbols
Date of manufacture
Manufacturer
General warning sign– (black on yellow)
1. Dear Customer ........................................................................................2
2. Conformity .............................................................................................2
3. General Information................................................................................2
4. Description of TRIOS ..............................................................................3
5. Safety and Warnings ................................................................................7
6. Cleaning, Disinfection, and Sterilization ................................................ 9
7. Disposal .................................................................................................. 11
8. Technical Maintenance ......................................................................... 12
9. Consumable Accessories ...................................................................... 12
10. Vigilance.............................................................................................. 12