3Shape TRIOS S1P-2 Setup-Handbuch - Seite 3
Blättern Sie online oder laden Sie pdf Setup-Handbuch für Zahnärztliche Ausrüstung 3Shape TRIOS S1P-2 herunter. 3Shape TRIOS S1P-2 13 Seiten.
Seite druckenType BF applied part
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 Instruction for Use (white on blue)
Warning (black on yellow): Possibly hazardous optical
radiation emitted from this product. 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 IOS system,
incl. safe working load (in kilograms)
Identifies the protection tip
Identifies the calibration tip
Medical Device
Global Trade Item Number
Prescription Only (applicable in the United States)
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, Registration, Evaluation, Authorization and
Restriction of Chemicals Regulation 1907/2006/EC, Restriction of Hazardous
Substances in Electrical and Electronic Equipment Directive 2011/65/EU, and
Waste Electrical and Electronic Equipment Directive 2012/19/EU.
CAUTION – EU only
CE marking for connected products
Further products which are connected to this unit must
also bear CE marking.
Electrical Safety
This system has been tested to conform with the EN (IEC) 60601-1
Safety Standard for medical electrical devices witha 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).
WARNING
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.
WARNING
Use of the UNIT adjacent to or stacked with other equipment
should be avoided because it could result in improper
operation. If such use is necessary, the UNIT and the other
equipment should be observed to ensure normal operation
in the used configuration.
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