3Shape TRIOS Посібник з налаштування - Сторінка 2
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Table of Contents
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 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10
7 . Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
8 . Technical Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
9 . Consumable Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
10 . Vigilance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
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 . c om
If you would like to receive a printable version of this manual or request a free
printed copy please contact 3Shape support via email support@3shape . c om .
2
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)
• Radio Equipment Directive (RED) 2014/53/EU
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 system . Safety information and warnings
are highlighted in this guide using the words WARNING,
CAUTION or 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 is not observed .
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- caution (black on yellow)
Type BF applied part