Setup Guide

ManualsBrandsTRIOS ManualsElectronics802.11 ac/a/b/g/n + Bluetooth 4.2 module / 802.11ac/a /b/g/n M.2 2230 + Bluetooth 4.2 module

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

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