3
ENGLISH
Mass of the TRIOS IOS system, incl. safe working load (in kilograms)
Medical Device
Global Trade Item Number
Prescription Only (applicable for United States of America)
Model Number
UKCA marking (applicable for Great Britain)
Device Quantity – indicates the number of pieces in the package
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 current editions of 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 MOVE+
must only be used indoors.
Electrical Safety
The TRIOS MOVE+ has been tested to conform with the safety standards for medical
electrical devices: IEC 60601-1:2005+ AMD1:2012 Medical electrical equipment – Part 1:
General requirements for basic safety and essential performance, and IEC 60601-1-2:2014
Medical Electrical Equipment - Part 1-2: General Requirements For Basic Safety And Essential
Performance - Collateral Standard: Electromagnetic Disturbances - Requirements And Tests.
The system has also been tested to conform with CAN/CSA-C22.2 No. 60601-1:2014 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 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 TRIOS MOVE+ is to be used in a Professional Healthcare Environment.
4.2 Intended Use
The TRIOS MOVE+ is intended to be used for visualizing 3D digital images of the topographical
characteristics of teeth captured by an intraoral scanner. See the online help for a list
of supported indications.
WARNING
Unintended use of the TRIOS MOVE+ can result in physical injury
to patients and operators and can cause damage to the system.
4.3 Users of the TRIOS MOVE+
The TRIOS MOVE+ is to be operated by legally qualified health care professionals in dental clinics.
4.4 Contra-indications
None.
4.5 Patient Target Group
There are no restrictions in patient population amongst the patient target group of the
TRIOS MOVE+.
4.6 Accessory Description
The TRIOS MOVE+ is available in these variants:
Regional variation can occur regarding the contents of the systems.
C4.1
Cart with built-in PC compatible with TRIOS 5.
For further information, please refer to the Safety & Setup guide for TRIOS 5 (L1P-1 and L1P-1F).
4.7 TRIOS MOVE+
TRIOS MOVE+ consists of:
C4.1 cart used for intraoral digital impression system.
Following description applies to the cart:
1
2
3
4
5
1
Movable
cart
Use the
TRIOS MOVE+
where it is
convenient
for you.
2
Stand
-
3
Wheelbase
-
4
Locking
caster
wheels
Lock the cart
safely in place.
5
Monitor
arm
Adjust the
height for better
view of the
screen.
6
Adjustable
monitor
Adjust the angle
for better view
of the screen.
7
Touch
screen
View real-time
scanning results
using the
TRIOS Module
software.
