3Shape L1P-1 Veiligheids- en installatie-instructies - Pagina 3

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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 (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 (IEC) 60601-1, EN (IEC) 60601-1-2,
EN (IEC) 60601-1-6, EN (IEC) 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 (IEC) 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 (IEC) 60601-1-2 Electromagnetic compatibility – Requirements and tests, and
EN (IEC) 62471 Photobiological safety of lamps.
The system has also been tested to conform with CAN/CSA-C22.2 No. 60601-1:14 and
AAMI/IEC 60601-1:2005 + AMD 1:2012.
CAUTION
Any person who assembles or modifies a medical electrical equipment or
system complying with the standard EN (IEC) 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 Intended Use

L1P-1: The 3Shape TRIOS system is intended to obtain 3D digital images of the topographical
characteristics of teeth, including bite, gingivae and palate directly from the patient's mouth
or models of the teeth.
L1P-1F (Indications for use): The L1P-1F intraoral scanner (IOS) System is intended to obtain
3D digital images of the topographical characteristics of teeth, including bite, gingivae and
palate directly from the patient's mouth or models of the teeth including the visualization
and comparison of the 3D scans of the secondary dentition. The L1P-1F system is also
intended for aid in diagnostics of caries.
CAUTION
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 "intended 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:
Regional variation can occur regarding the contents of the systems.
L1P-1
TRIOS scanner, supplied with scanner tips, protection tip, sleeve,
pod (holder), batteries, and battery charger.
L1P-1F
TRIOS scanner, supplied with scanner tips, protection tip, sleeve,
pod (holder), batteries, battery charger, TRIOS Patient Monitoring
(TPM) software.
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