3Shape L1P-1F Инструкции по безопасности и настройке - Страница 2
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Печатать страницуTable of Contents
1. Welcome Note
2. Conformity
3. General Information
3.1 About this Document - Symbols .................................................................................... 2
3.2 Legend of Labels and Symbols........................................................................................ 2
4.1 Certification and Compliance Notes .............................................................................. 3
4.2 Intended Use .................................................................................................................. 3
4.3 Users of the TRIOS System ............................................................................................. 3
4.4 Contra-indications ......................................................................................................... 3
4.5 Patient Target Group ...................................................................................................... 3
4.6 System Description ........................................................................................................ 3
4.7 TRIOS Scanner, TRIOS Scanner Tip and TRIOS Protection Tip Description ....................4
4.8 Battery and Battery Charger Description .......................................................................4
4.9 Other System Elements Description ..............................................................................4
4.11 Starting and Shutting Down the TRIOS System ............................................................. 5
4.12 Starting TRIOS Online Help ........................................................................................... 5
4.13 Storage, Operating and Transport Conditions .............................................................. 5
4.14 Technical Specifications ................................................................................................ 5
4.15 Electromagnetic Compability ....................................................................................... 5
4.16 Declaration - Electromagnetic Emissions .................................................................... 6
4.17 Electromagnetic Immunity ........................................................................................... 6
4.18 Distances Between System and Other Equipment ....................................................... 6
5.1 Prerequisites .................................................................................................................... 7
5.2 Potential Mechanical Damages ...................................................................................... 7
5.3 Explosion Hazards .......................................................................................................... 7
5.4 Electrical Safety .............................................................................................................. 8
5.5 Eye Safety........................................................................................................................ 8
5.6 Hygiene .......................................................................................................................... 8
5.7 Safety when Scanning ..................................................................................................... 8
5.8 Epileptic Seizure ............................................................................................................. 9
5.9 Protection from Overheating ......................................................................................... 9
5.10 EMC Safety .................................................................................................................... 9
6. TRIOS Sleeve ....................................................................................................... 9
7. Cleaning, Disinfection, and Sterilization ............................................................... 9
7.1 TRIOS Scanner Body and Mirror Housing: Cleaning and Disinfection............................. 9
7.2 Pod: Cleaning and Disinfection ..................................................................................... 10
7.3 TRIOS Scanner Tip: Cleaning and Sterilization .............................................................. 10
7.4 Cleaning of Batteries, Battery Charger and Other Parts of the System ......................... 11
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1. Welcome Note
Dear Customer,
Thank you for purchasing your TRIOS system from 3Shape TRIOS A/S.
The TRIOS system enables you to obtain oral scans of patient's teeth
for use in dental CAD/CAM systems.
This TRIOS system safety and setup guide describes safety precautions, warnings, and
considerations related to your TRIOS system. 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 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 follow all safety information and warnings to avoid personal injury,
material damage or damage to your TRIOS 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
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
• 94/62/EEC Packaging and Waste Directive
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
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 system. 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
Type BF applied part