3Shape TRIOS Manual de configuração - Página 3

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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 )

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

RFID tag

Electrical insulation Class II

Medical Device

Global Trade Item Number

Prescription Only (applicable for United States of America)

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, Waste

Electrical and Electronic Equipment Directive 2012/19/EU, 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 the CE marking .

IMPORTANT NOTICE

To comply with the CE marking of the integrated wireless

module, the wireless 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 perfor-

mance - 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 equip-

ment) 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 .