3Shape TRIOS - Description of TRIOS

3
ENGLISH
WEEE Product disposal symbol
Caution
CE marking
Lot number
Serial Number
Consult instructions for use
Alternating Current
Protective earth (ground)
Warning- dangerous voltage (black on yellow)
Expiry Date
Standby
LAN
Local area network, Ethernet connector (RJ45)
Refer to instruction manual / booklet.
Follow instructions for use (blue on white )
Identifies theprotectiontip
Identifies thecalibrationtip
Warning- Possibly hazardous optical radiation emitted from
this product (black on yellow). Do not stare at operating
lamp. May be harmful to the eyes. The present system is in
risk group 2
The calibration patches must not be touched and must not
be exposed to liquids (red on white)
Mass of the TRIOS System, incl. safe working load (in
kilograms)
The product contains an RF transmitter
Prescription Only (applicable for United States of America)
Max ON
30 min
Min OFF
10 min
Duty Cycle.
Maximum ON time 30minutes / Minimum OFF time
10minutes
Electrical insulation Class II
Medical Device
Global Trade Item Number
Model Number
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, Restriction of Hazardous
Substances in Electrical and Electronic Equipment Directive 2011/65/EU,
and Waste Electrical and Electronic Equipment Directive 2012/19/EU.
Registration, Evaluation, Authorization and Restriction of Chemicals
Regulation 1907/2006/EC, Radio Equipment Directive 2014/53/EU.
CAUTION – EU only
CE marking for connected products.
Further products which are connected to this unit must
also bear CE marking.
IMPORTANT NOTICE
To comply with the CE marking of the integrated wireless
module, the 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 Medical
electrical equipment – part 1-2: General requirements for basic safety and
essential performance - Collateral Standard: Electromagnetic disturbances-
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 ANSI/AAMI ES60601-1 +C1(2009) + A1 (2012) + A2 (2010).