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ENGLISH

Table 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. Description of TRIOS 

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. System Safety

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

8. Optical Maintenance

9. Disposal

10. Technical Maintenance

11. Consumable Accessories

12. Vigilance

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

Summary of Contents for L1P-1

Page 1: ...APR 2022 3Shape TRIOS 5 Safety and Setup Guide L1P 1 L1P 1F...

Page 2: ...system please carefully read and follow the instructions in this safety and setup guide and in the online helpsystem Pleasealwayskeepthissafetyandsetupguidenearthesystem Please follow all safety infor...

Page 3: ...safety requirements for medical electrical equipment by combining it with other equipment is responsible for conducting appropriate inspection and testing to ensure continued safe use of the equipment...

Page 4: ...Systembe performed byTRIOSauthorizedtechnicalservicepersonnel It is recommended to fully charge batteries for the TRIOS scanner before use CAUTION Let the system adjust to room temperature before use...

Page 5: ...midity 10 85 non condensing Atmospheric pressure 800 1100 hPa Transport Conditions Ambient temperature range 10 50 C 14 122 F Relative humidity 10 85 Non condensing Atmospheric pressure 620 1200 hPa 4...

Page 6: ...e b V1 3 Vrms V2 6 Vrms Note b Radiated RF IEC 61000 4 3 3 V m 80 MHz to 2 7 GHz E1 3 V m 80 MHz to 2 7 GHz Electromagnetic environment guidelines Portable and mobile RF communications equipment shoul...

Page 7: ...Connection The wireless TRIOS scanner is intended to be used indoors in a domestic or commercial electromagnetic environment The wireless connection is intended to relay image stream dataandcontrolda...

Page 8: ...ion in visual acuity and afterimages leading to irritation annoyance visual impairment and even accidents depending on the situation 5 6 Hygiene Forinstructionsonhowtomountthesingle usesleeveseetheTRI...

Page 9: ...nner during patient examination WARNING The TRIOS Sleeve must only be used once to avoid cross contamination 7 Cleaning Disinfection and Sterilization The following TRIOS system items shall be cleaned...

Page 10: ...ants Dispose of the CaviWipe Step 3 Remove gross contaminants from metal holder Take a CaviWipe Wipe the surface of the metal holder to remove any gross contaminants Dispose of the CaviWipe Step 4 Dis...

Page 11: ...TRIOS scanner window follow these steps for optimal scan quality Step 1 Take a damp non woven swab and gently rub it on the inside and outside of the TRIOS scanner tip window as well as on the window...

Page 12: ...10030138A April 2022 Copyright 3Shape TRIOS A S More information at 3Shape com Let s change dentistry together 3Shape TRIOS A S Holmens Kanal 7 1060 Copenhagen Denmark...

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