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ENGLISH
WEEE Product disposal
Caution
CE marking applicable for European Union
Lot number
Serial Number
Consult instructions for use
Alternating Current
Protective earth (ground)
Warning – dangerous voltage
Expiry Date
Standby
Refer to instruction manual / booklet. Follow instructions for use
Electrical insulation Class II
Medical Device
Global Trade Item Number
Prescription Only (applicable for United States of America)
Model Number
UKCA marking (applicable for Great Britain)
Disposal information: Li-ion battery recycling
Device Quantity – indicates the number of pieces in the package
Do not re-use
Country of manufacture – “CC” denotes the country code
Unique Device Identifier
4. Description of TRIOS
4.1 Certification and Compliance Notes
CE marking
This product bears CE marking in accordance with the provisions of Medical Device
Regulation (EU) 2017/745, (MDR); Restriction of Hazardous Substances in Electrical and
Electronic Equipment Directive 2011/65/EU (RoHS 2); 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 60601-1,
EN 60601-1-2, EN 60601-1-6, EN 62471.
CAUTION – EU only
CE mark for connected products
Further products which are connected to this unit must also bear the CE marking.
IMPORTANT NOTICE
To comply with the CE marking of the TRIOS system, the TRIOS scanner
must only be used indoors.
Electrical Safety
This system has been tested to conform with the EN 60601-1 Safety Standard for medical
electrical devices with a Patient applied part (the standard title is: Medical electrical equipment –
Part 1: General requirements for basic safety and essential performance), EN 60601-1-2
Electromagnetic compatibility – Requirements and tests, and EN 62471 Photobiological
safety of lamps.
The system has also been tested to conform with CAN/CSA-C22.2 No. 60601-1:14 and
AAMI/EN 60601-1:2005 + AMD 1:2012.
CAUTION
Any person who assembles or modifies a medical electrical equipment or
system complying with the standard EN 60601-1 (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 and for ensuring that the requirements
of this regulation are met to their full extent for the safety of the patients,
the operators and the environment.
CAUTION
The product needs special precautions regarding electromagnetic
compatibility (EMC) and needs to be installed and put into service according
to the EMC information.
IMPORTANT NOTICE
The system is to be used in a Professional Healthcare Environment.
4.2 Indications for use
L1P-1F: The L1P-1Fintraoral scanner (IOS)system is intended for aid in diagnosis of caries.
WARNING
Unintended use of the TRIOS system can result in physical injury to patients,
operators and damage the system.
4.3 Users of the TRIOS System
The 3Shape TRIOS system is to be operated by legally qualified healthcare professionals in
dental clinics. Using the TRIOS system for any purpose other than the “4.2 Indications for use”
described above may damage the TRIOS system and harm operators and patients.
Proper use of the TRIOS system includes following the operation and maintenance
instructions, and observing warnings and caution descriptions in this user guide.
4.4 Contra-indications
None.
4.5 Patient Target Group
The are no restrictions in patient population amongst the patient target group
of the TRIOS system.
4.6 System Description
The system is available in these variants:
L1P-1F TRIOS scanner, supplied with scanner tips, protection tip, sleeve,
pod (holder), batteries, battery charger, TRIOS Patient Monitoring
(TPM) software. Compatible with TRIOS MOVE+.
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