3Shape TRIOS 5 Safety and Setup Guide L1P-1, L1P-1F APR 2022
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............................
IMPORTANT NOTICE To comply with the CE marking of the TRIOS system, the TRIOS scanner must only be used indoors. Caution CE marking applicable for European Union Lot number Serial Number ENGLISH CAUTION – EU only CE mark for connected products Further products which are connected to this unit must also bear the CE marking.
ENGLISH 4.7 TRIOS Scanner, TRIOS Scanner Tip and TRIOS Protection Tip Description TRIOS system consists of: 4.10 Setting up TRIOS It is recommended that unpacking, assembly and connection of the TRIOS System be performed by TRIOS authorized technical service personnel. It is recommended to fully charge batteries for the TRIOS scanner before use. TRIOS Scanner (L1-2): Wireless handheld dental intraoral scanner for scanning a patient.
4.11 Starting and Shutting Down the TRIOS System Please follow the steps below to start TRIOS system for the first time: ENGLISH Storage Conditions Ambient temperature range: -10 – +50 °C (+14 – +122 °F) Relative humidity: 10 – 85 % (non-condensing) Step 1: Turn the PC on. Atmospheric pressure: 800 – 1100 hPa Start 3Shape software. Transport Conditions Ambient temperature range: -10 – +50 °C (+14 – +122 °F) Step 2: Log on using a default TRIOS Operator.
ENGLISH 4.16 Declaration – Electromagnetic Emissions The TRIOS system complies with the requirements EN/(IEC) 60601-1-2 (Edition 4.0) clause 7 Emissions. The TRIOS system is intended for use in the electromagnetic environment specified below. The user or users of the TRIOS system should assure that it is used in such an environment. Emission measurement RF emission CISPR11 RF emission CISPR11 Harmonic emission Conformity Group 1 The TRIOS system uses RF energy only for its internal functions.
Note 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. Models L1P-1 & L1P-1F Connection Type Recommended use distances Scanner – PC Wireless Distance between TRIOS scanner and wifi dongle/ access point should be between 0.5 and 5m for best performance. 5.
ENGLISH 5.4 Electrical Safety Do not access the inside of any part of the system 5.6 Hygiene For instructions on how to mount the single-use sleeve see the TRIOS Sleeve instructions for use. For instructions on cleaning and disinfection or sterilization go to section 7. WARNING There is a risk of electrical shock if you attempt to access the inside of any part of the system. Only authorized and qualified service personnel may access the inside of any part of the system.
5.8 Epileptic Seizure WARNING There is a risk of injuries if the scanner tip is bitten. As a direct effect of an epileptic seizure, various degrees of involuntary biting can occur. Avoid any patient biting on the scanner tip or bumping the scanner tip into the teeth. ENGLISH Cleaning/disinfectant wipes containing Isopropanol (17.2%) and Ammonium Chloride e.g. CaviWipes. Soft bristled brush E.g. Curaprox ultra soft toothbrush. 5.
ENGLISH Dispose of the CaviWipe. Wipe the surface of the metal holder to remove any gross contaminants. Dispose of the CaviWipe. Step 4: Disinfect Take a CaviWipe. Step 4: Disinfect rubber insert Wet the surface of the TRIOS scanner body and mirror housing with the CaviWipe for a minimum of 120 seconds to disinfect. Take another CaviWipe. Allow to dry. Dispose of the CaviWipe. Wet the surface of the rubber insert for minimum 120 seconds to disinfect. Place TRIOS protection tip on TRIOS scanner.
8. Optical Maintenance ENGLISH Dry the TRIOS scanner tip carefully with a nonwoven swab. In case of smudges or stains on the TRIOS scanner tip window or the 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 on the mirror housing. Step 3: Sterilize TRIOS scanner tip Put the TRIOS scanner tip in a sterilization pouch.
10030138A April 2022 Copyright 3Shape TRIOS A/S Let’s change dentistry together 3Shape TRIOS A/S Holmens Kanal 7 1060 Copenhagen Denmark More information at 3Shape.
