3shape Trios s3p-2 User manual

04-2021

3Shape TRIOS

Safety and Setup Guide

S3P-2, S3P-8, S3A-10, S3A-14, S3A-18, S3A-22

ENGLISH

Table of Contents

1. Dear Customer

Thank you for purchasing your TRIOS® intraoral scanner (IOS) system from

3Shape TRIOS A/S. The TRIOS IOS system enables you to perform and digitally

save oral scans of patient’s teeth for use in dental CAD/CAM systems.

This TRIOS safety and setup guide describes safety precautions, warnings, and

considerations related to your TRIOS IOS system. For step-by-step instructions

regarding configuration and operation of TRIOS, please refer to the online help.

Before assembling or using TRIOS IOS system, please carefully read and follow

the instructions in this safety and setup guide and in the online help system.

Please always keep this safety and setup guide near the system.

Please observe all safety information and warnings to prevent personal

injury, material damage or damage to your TRIOS IOS system.

Thank you,

3Shape TRIOS A/S

2. Conformity

This guide is published by 3Shape TRIOS A/S, who reserves the right

to improve and modify the contents without prior notice. Modifications

TRIOS is a trademark of 3Shape TRIOS A/S.

Manufacturer Information

3Shape TRIOS A/S, located at Holmens Kanal 7, 1060 Copenhagen, Denmark

is legal manufacturer for devices listed in this guide.

To learn more about 3Shape, our products and global office locations please

visit our website: www.3shape.com

If you would like to receive a printable version of this manual or request a free

printed copy please contact 3Shape support via email support@3shape.com.

Declaration of Conformity (EU):

3Shape TRIOS A/S hereby declares that the TRIOS observes the provisions of:

• Medical Device Regulation (EU) 2017/745, (MDR),

• Restriction of Hazardous Substances in Electrical

and Electronic Equipment Directive 2011/65/EU (RoHS),

• 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.

3. General Information

CAUTION

Be sure to observe all warnings!

Please observe all safety information and warnings

to prevent personal injury, material damage or damage

to your TRIOS system. Safety information and warnings

are highlighted in this guide using the words WARNING,

CAUTION or NOTICE.

3.1 About this Document – Symbols

The symbols used in this document imply the following:

WARNING

Warnings regarding situations where a medium risk of injury

to persons exists if the information is not observed.

CAUTION

Safety information where hazards such as slight risk

of injury to persons, risk of property damage or damage

to the system exist if the information is not observed.

IMPORTANT NOTICE

Important information that is not a warning/caution

but must be strictly observed.

TIPS

Hints, tips, additional information to support optimal

operation of the system.

3.2 Legend of Labels and symbols

Date of manufacture

Manufacturer

General warning sign– caution (black on yellow)

Type BF applied part

1. Dear Customer........................................................................................2

2. Conformity .............................................................................................2

3. General Information................................................................................2

4. Description of TRIOS ..............................................................................3

5. Safety and Warnings................................................................................7

6. Cleaning, Disinfection, and Sterilization...............................................10

7. Disposal................................................................................................. 12

8. Technical Maintenance......................................................................... 13

9. Consumable Accessories ...................................................................... 13

10. Vigilance.............................................................................................. 13

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 )

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.

ENGLISH

WARNING

Use of the UNIT adjacent to or stacked with other equip-

ment 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.

WARNING

The product needs special precautions regarding electro-

magnetic compatibility (EMC) and needs to be installed and

put into service according to the EMC information provided

in the TRIOS Technical Data.

IMPORTANT NOTICE

The system is to be used in a Professional Healthcare

Environment.

4.2 Intended Use

The 3Shape TRIOS 4 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.

CAUTION

Unintended use of the TRIOS IOS system can result in phys-

ical injury to patients, operators and damage the system.

4.3 Users of TRIOS

The 3Shape TRIOS intraoral scanner system is to be operated by legally quali-

fied healthcare professionals in dental clinics. Using the TRIOS IOS system for

any purpose other than the intended use described above may damage the

TRIOS IOS system and harm operators and patients. Proper use of the TRIOS

IOS system includes following the operation and maintenance instructions,

and observing warnings and caution descriptions in this user guide.

WARNING

Carefully follow the instructions in this guide

If the instructions for operating the TRIOS IOS system

as described in this guide are NOT observed, the intended

protection and safety of the user and patient may be impaired.

4.4 Contra-indications

None

4.5 Patient Target Group

No restrictions in patient population

4.6 System Description

The system is available in these variants:

Regional variation can occur regarding the contents of the systems.

S3P-2 Pen grip scanner, supplied with a pod (holder),

3 scanner batteries, and a scanner battery charger

S3P-8 Pen grip scanner, supplied with a pod (holder)

that is connected to an external PC via an Ethernet cable,

and a TRIOS 4 cord

S3A-10 Pen grip scanner, supplied with a MOVE® cart with built-in PC,

and a TRIOS 4 cord

S3A-14 Pen grip scanner, supplied with a MOVE cart with built-in

PC, 3 scanner batteries, and a scanner battery charger

S3A-18 Pen grip scanner, supplied with a MOVE®+ cart with

built-in PC, and a TRIOS 4 cord

S3A-22 Pen grip scanner, supplied with a MOVE+ cart with built-in

PC, 3 scanner batteries, and a scanner battery charger

You can find the figures in the final section of this guide.

All system variants comprise:

• Handheld TRIOS intraoral scanner, S3-2 (S1 and S2):

Wired and wireless handheld dental intraoral scanner

for scanning the surface of the patient’s teeth.

• TRIOS 4 SmartTip, TST-01 (S3): Re-usable scanner tip attached to the

handheld TRIOS Scanner. The scanner tip must be cleaned and sterilized

prior to first use on a patient and after each use on a patient.

The scanner tip as well as the protection tip (S4) can be attached

by the following procedure:

1. Place the tip over the front tube with the mirror facing upwards

or downwards.

2. Twist the tip until a firm mechanical click is felt.

3. The tip is removed doing the opposite procedure:

4.Twist the tip away from the center of the scanner.

5. Pull the tip away from the scanner body (S4).

The label on the protection tip indicates the attaching/removing movement

(S4). When the tip is detached, the scanner’s optical window (S3) is visible.

The TRIOS 4 tip contains a mirror and electronics. A set of scanner tips

is delivered with the scanner. The scanner tip is the only applied part.

• Protection Tip, TST-03 (S4): Protects the optical window of the scanner

from damage and dirt when the scanner is not in use.

• Color Calibration Kit, TST-02 (S5): Used for calibrating TRIOS scanners.

The kit consists of the color calibration target (S6), the sleeve (S7), and

the color calibration adaptor (S8).

• TRIOS software: Scan application/user interface for the scanner.

• Power (mains) cable and plug: The system is delivered with a cable

appropriate for your location. In the USA and Canada, this is a Nema 5-15P

Hospital Grade mains power cord with plug for the MOVE/MOVE+ cart.

For the charger a C7 connector is used.

• A set of batteries for the scanner, TB-02 or TB-03 (S9)

• A battery charger, C3BP, with wall mount (S10)

For systems S3A-10, S3P-8:

• TRIOS 4 cord, TSC-01 (S11): The wired systems are delivered with a cord,

which is inserted in the scanner by pressing the button as shown in (S2).

The blue light indicates a connection to either the Pod or the MOVE+ cart.

The green light indicates a connection to the scanner.

System S3A furthermore comprises:

• MOVE cart C 4.0 and MOVE+ cart C 4.1 (Figure 2), for intraoral digital

impression system.

Following description applies to both MOVE and MOVE+ cart:

• Has an adjustable monitor (S12, S13, S14).

• Has a scanner mount (S15) for holding the scanner while not in use.

• Has wheels for mobility (and brakes (S16) if mobility is not desired).

• Computer Unit. Attached to the MOVE/MOVE+ cart for processing,

storage and running the TRIOS software.

ENGLISH

• Touch screen: Touch-enabled screen for real-time display of scanning

results generated by the TRIOS software, and for interacting with the

TRIOS software.

• The system standby button (S17) is on the back of the monitor.

• In the bottom (S18), there is a power socket (S19), a network (LAN)

connector (S20), and a fuse drawer (S21). In the top of the backpack

(Figure 7), the dongles are inserted, see description below.

• USB wireless dongle (allows communication between scanner and

computer or cart)

• USB license dongle (access to 3Shape Software)

• USB wifi dongle (for connecting cart to wifi network)

• Bluetooth dongle (for connecting the cart to Bluetooth devicesas

keyboard and mouse)

• USB port (only MOVE+): The MOVE+ has a USB port (S29).

The friction of the arm of the MOVE/MOVE+ cart that holds the scanner

and the display can be adjusted. The corresponding tool is provided with

the system. (Figure 8)

Step 1: Move the arm to the top-most position.

Step 2: Insert the tool into the hole on the bottom side of the arm,

located approx. half way along the arm.

Step 3: Turn the tool clockwise to increase friction, anticlockwise

to reduce friction.

Step 4: Adjust friction so that the monitor is steady (does not sink,

does not go up) in the following scenarions:

• Scanner is positioned in scanner holder

• Scanner is not positioned in scanner holder

IMPORTANT NOTICE

Maximum current available for the USB port is 200 mA.

System S3P furthermore comprises (Figure 3 and 4):

Pod, PS3-4 (S22) (Figure 3):

• A mount for the scanner

• A USB wireless dongle for the PC (S23)

• A USB license dongle

Pod with electronics, PS3-2 (Figure 4):

• A mount for the scanner with several connection sockets. On one side,

there is a single socket for the scanner. On the other side, there are two

connection sockets for the Ethernet cable to the PC and for the external

medical power supply, respectively.

• A USB license dongle

4.7 Setting up TRIOS

It is recommended that unpacking, assembly and connection of the TRIOS

IOS System be performed by TRIOS authorized technical service personnel.

It is recommended to fully charge batteries for the scanner before use.

CAUTION

If the system has just been delivered from a cold environ-

ment, let it adjust to room temperature to avoid internal

condensation and to allow for proper calibration.

CAUTION

Examine all parts of the system. Look for physical damage,

loose parts or signs of wear that could interfere with proper

use and functionality. Contact your service provider if there

is visible damage or malfunctioning.

System S3A (MOVE/MOVE+ cart) only

Please follow the steps below for assembling TRIOS IOS system (Figure 5):

Step 1: Place the MOVE/MOVE+ cart optimally in relation to the patient

chair and your work position. (S24)

Step 2: Attach the protection tip to the TRIOS scanner if not already

in place. (S25)

Step 3: Insert a battery fully into the rear of the scanner (S26) or insert

the TRIOS 4 cord into rear of scanner (S27) and connect the scanner

cable to the scanner connection socket on the MOVE/MOVE+ cart

behind the screen below the hinge (S28)

Step 4: Place the scanner in its designated scanner holder on the

MOVE/MOVE+ cart (Figure 2, S15).

Step 5: Connect the MOVE/MOVE+ cart end of the power cable to the

socket in the bottom of the MOVE/MOVE+ cart’s base. (Figure 2, S19)

Step 6: Connect the power cable to a grounded power outlet. Ensure

that the MOVE/MOVE+ cart is placed so it does not block the switch on

the mains socket outlet. To isolate the MOVE/MOVE+ cart and thus the

scanner from supply mains, unplug the flexible power cord from mains.

System S3P (Pod) only

Please follow the steps below for assembling TRIOS IOS system (Figure 6):

Before you start: Place the pod on a flat and horizontal surface optimally

in relation to the patient chair and your work position. Attach the protec-

tion tip to the TRIOS scanner if not already in place. For the wired scanner,

we recommend not to place the scanner onto the pod at this time yet, so

that it is easier to lift the pod while connecting cables in the following.

For the wired scanner (for the wireless scanner, begin with step 6)

Step 1: Connect the Ethernet cable to the pod. The cable goes into the left

connection socket on the back side of the pod (the side that has two

connection sockets). If you need to release the Ethernet cable, press

on the small tab on the top of the connector.

Step 2: Connect the power supply to the pod. This cable goes into the con-

nection socket next to the Ethernet cable described in the previous step.

• To connect - push the plug into socket. There are red orientation

dots on the socket and the plug that should match.

• To disconnect - pull on the outer release sleeve.

The indicator light will light green.

Step 3: Connect the TRIOS 4 cord to the scanner connection socket on

the front side of the pod (the side that has only one connection socket).

• To connect - push the plug into the socket. There is a red orientation

dot on the plug that should point upwards.

• To disconnect - pull on the outer release sleeve.

Now all connections to the pod are established, and you can place the

scanner onto the pod.

ENGLISH

Step 4: Connect the other end of the Ethernet cable to the PC

(if no Ethernet ports are available in the PC, use an Ethernet-to-USB adapter).

Step 5: Connect the power (mains) cord to the power supply. The other

end of the power (mains) cable goes into a grounded power outlet

(not shown in the Figure). To isolate the pod and thus the scanner from

supply mains, unplug the power cord from mains.

Step 6: Insert a battery fully into the rear of the scanner. (Figure 5, S26)

or Insert the TRIOS 4 cord into rear of scanner (Figure 5, S27).

Step 7: Place the scanner in the pod.

Scanner Battery Charging (Figure 1, S9 and S10):

Before you start: Place the battery charger either on a flat surface hori-

zontally or attach it to the wall mount vertically, with battery containers

pointing upwards.

Step 1: Attach the power cord and plug it to mains power.

Step 2: Push the batteries one by one into the charger until they click into

place. When charging, the LED above each battery will indicate the status:

• A pulsating green means that charging is ongoing;

• Constant green means that the charging is completed;

• Yellow means that an error has occurred, either the battery is not

inserted correctly, or the charging is outside operating conditions

for temperature.

CAUTION

If the charger continues to indicate yellow, the battery

is damaged and should be discarded, unless the battery

is too hot or too cold (see section 4.8).

4.8 Starting and Shutting Down TRIOS

Please follow the steps below to start TRIOS IOS system for the first time:

Step 1: Turn the system ON.

S3A: Press the standby button on the top of the backside of the display.

The TRIOS software starts automatically.

S3P: Start the PC. If the PC has no TRIOS software pre-installed, please

install the TRIOS software first. In case of difficulties with software instal-

lation, plase contact 3Shape support.

Step 2: Log on using a default TRIOS Operator.

Step 3: Configure and use your TRIOS IOS system.

For models S3P-8, S3A-10, S3A-18

The wired scanner turns on automatically when the MOVE/MOVE+ cart

is turned on, or when the smart cord is plugged into the scanner.

For models S3P-2, S3A-14, S3A-22

To activate the wireless scanner, press the button on the top of the

scanner when the MOVE/MOVE+ cart or computer is turned on.

The scanner can be turned off manually by removing the battery.

Follow on-screen instructions for connecting to the wireless scanner.

When using the TRIOS IOS system, the user is guided by messages shown

in the TRIOS software. This includes when calibration of the scanner

is due. Other messages include a reminder to mount the scanning tip:

“Please make sure the scanning tip is mounted on the scanner.”

Calibration

A calibration of the handheld TRIOS scanner is required before using TRIOS

for the first time, or to compensate for thermal variation and aging effects

due to wear. During regular use the TRIOS software will prompt the user

when calibration is due. To perform the calibration, attach a cleaned and

sterilized or high-level disinfected scanner tip on the scanner tube.

Remove the sleeve from the calibration target.

Mount the calibration target on the calibration adaptor with the grey side,

marked with the letter B, facing up.

Attach the calibration adaptor to the cleaned and sterilized or high-level

disinfected scanner tip. Go to the Settings page in the TRIOS software, select

TRIOS →Scanner Management →3D calibrate scanner, and then follow the

on-screen instructions. Remember to save changes when prompted.

For a more detailed description of the 3D calibration, please refer to the

TRIOS online help.

Color Calibration

A color calibration of the handheld scanner is required

before each scan in order to get optimal colors.

Attach a cleaned and sterilized or high-level disinfected

scanner tip on the scanner tube.

Remove the sleeve from the color calibration target.

Mount the color calibration target to the calibration adaptor

with the color side, marked with the letter A, facing up.

Attach the calibration adaptor to the cleaned and sterilized

or high-level disinfected scanner tip.

Go to the Settings page in the TRIOS software, select TRIOS →Scanner

Management →Color calibrate scanner, and then follow the on-screen

instructions, which will also include validation of the performed color cali-

bration. Remember to save changes when prompted.

For a more detailed description of the color calibration,

please refer to the TRIOS online help.

Proper shutdown

Inside the TRIOS software, click on the Power button and select Shutdown

or press the the standby button on the back of the monitor on the MOVE/

MOVE+ cart. System S3A (MOVE/MOVE+ cart) only: The light under the

standby button turns off to confirm that the system is shut down.

CAUTION

When switching off the system, allow enough time for it to

shut down properly before disconnecting the mains cable.

System S3A (MOVE/MOVE+ cart) only

IMPORTANT NOTICE

The standby button can also be used to force TRIOS IOS

system to shut down in case the screen stops responding.

To force a shutdown, push and hold the standby button

pressed for about 5 seconds. Then, restart the system.

4.9 Starting TRIOS Online Help

The TRIOS online help can be started from the TRIOS software by clicking

on the Help button and choosing User Manual.

ENGLISH

4.10 TRIOS System Environment

IMPORTANT NOTICE

Operating Conditions

Ambient temperature range: +15 – +30 °C

Relative humidity: 10 – 85 % (non-condensing)

Atmospheric pressure: 800 – 1100 hPa

The scanner should be used in an environment

maintaining a consistent room temperature.

IMPORTANT NOTICE

Storage Conditions

Ambient temperature range: -10 – +60 °C

Relative humidity: 10 – 85 % (non-condensing)

Atmospheric pressure: 800 – 1100 hPa

IMPORTANT NOTICE

Transport Conditions

Ambient temperature range: -10 – +60 °C

Relative humidity: 10 – 85 % (Non-condensing)

Atmospheric pressure: 620 – 1200 hPa

4.11 Technical specifications

Light source

specifications

Do not view directly with optical instruments, such

as spectacle microscopes. The product complies

with EN (IEC) 62471 Photobiological safety of lamps

and lamp systems.

Sterilization

and high-level

disinfection

method

Scanner tips can be autoclaved

or high-level disinfected.

Power input C4.0/ C4.1 MOVE/MOVE+ cart (for S3A)

Power input: 100-240 V AC, 50/60 Hz,

180 VA max Insulation class: class I

PS3-2 pod (for wired S3P)

External medical-grade power supply, rated 30

W max Power input: 100-240 V, 1.0 A, 50/60 Hz

Insulation class: Class I

C3BP: Battery charger

Power input: 100-240 V, ~0.3-0.7 A, 50/60 Hz

Protection class: IP20

Insulation class: Class II

S3-2 scanners.Wireless- battery powered

S3-2 scanners. Wired- TRIOS 4 cord

3Shape TB-02 Rechargeable Battery

3,6 V, 2000 mAh, 7 Wh

3Shape TB-03 Rechargeable Battery

3.6 V, 3450 mAh, 12 Wh

Wireless

Module

The scanner contains an IEEE 802.11ac module,

FCC ID: PD98265NG

Wireless

Transmit Power

Maximum 100 mW

Wireless

Frequency Band

2.401-2.483 GHz

5.15-5.725 GHz

(the actual frequencies are dependent on local reg-

ulations and the configuration of the product.)

5. Safety and Warnings

5.1 Prerequisites

CAUTION

Read all instructions carefully, including all warnings

and caution notices. You must comply with the warnings

in this manual to prevent injury to persons and damage

to equipment. Proper functionality and safety can only

be guaranteed if the safety precautions in this safety guide

and on the TRIOS IOS system are observed.

Country dependent feature: Fluorescence scanning mode.

CAUTION

In fluorescence scanning mode:

• Limit exposure of the oral mucosa.

• Limit scanning time to 15 seconds per tooth.

• Take appropriate measures for eye protection.

• Only run the scanner in fluorescence mode while

it is in the patient’s mouth.

• Do not direct the blue light emitted by the scanner

towards the eyes of the patient or operator.

• Consider using eyewear that blocks blue light.

• Consider viewing the computer screen while scanning

instead of the mouth of the patient.

Preventive inspection before use of the system

CAUTION

Please examine the TRIOS IOS system for any mechanical

damage on:

• all enclosures,

• all cables.

Safety can only be guaranteed if NO DAMAGE

on the TRIOS IOS system is observed.

Modifications of the system

CAUTION

Modifications of the system which may affect the safety of

the operator, patients or third parties are prohibited by law!

Approved software only

CAUTION

Install only approved software – to prevent interference

with the runtime reliability of the system and programs

within it.

Proper training

WARNING

Before you attempt to use the TRIOS scanner equipment

with patients:

• You must be trained to use the system and have read and

understood all sections of this guide describing correct

operation.

• You must also be thoroughly familiar with the safe opera-

tion of the TRIOS scanner equipment as described in this

documentation.

ENGLISH

In case of equipment failure

WARNING

If at any time the TRIOS IOS system malfunctions,

or if you suspect in any way that the TRIOS IOS system

is not working correctly:

• Remove the scanner from contact with the patient.

• Unplug the system and make sure it cannot be used

before it is checked.

• Contact your reseller.

• Do not attempt to open any covers on the TRIOS IOS system.

Portable RF communications equipment

WARNING

Portable RF communications equipment (including periph-

erals such as antenna cables and external antennas) should

be used no closer than 30 cm (12 inches) to any part of the

MOVE/MOVE+ cart system, including cables specified by

the manufacturer. Otherwise, degradation of the perfor-

mance of this equipment could result.

Wireless Connection

The wireless scanner is intended to be used indoors, in a domestic

or commercial electromagnetic environment.

CAUTION

Other portable and mobile RF communication equipment

could interfere with the wireless scanner, even if the other

equipment complies with CISPR emission requirements.

CAUTION

The wireless scanner could interfere with other portable

and mobile RF communication equipment.

CAUTION

It is recommended to keep a line of sight between the

wireless scanner and the USB wireless dongle attached

to the PC.

5.2 Mechanical Hazards

Fragile and movable parts

WARNING

Be careful to avoid the following potential sources of injury:

• Do not lean or sit on any part of the system.

• Movable parts can pinch body parts.

Dropped or damaged equipment

WARNING

If you drop a scanner tip on the floor, you MUST dispose

of it immediately and NOT use the same tip again for

scanning. There is risk that the mirror in the tip has become

dislodged and can fall out.

WARNING

If the handheld scanner is dropped or bumped, it should

immediately be calibrated before further use. If calibration

fails, please contact your technical service provider. See this

guide’s instructions on calibrating the handheld scanner.

WARNING

If the handheld scanner is dropped, examine the TRIOS

IOS system for any mechanical damage. If a mechanical

damage is observed or suspected, treat this as an equip-

ment failure (see this guide’s instructions on handling

equipment failures).

WARNING

If a battery is dropped, examine it for any mechanical

damage. If a mechanical damage is observed or suspected,

the battery must be disposed of in the correct manner.

System S3A (MOVE/MOVE+ cart) only

WARNING

• Keep both hands on the upper part of the MOVE/MOVE+

cart when moving it across the floor.

• Do not attempt to lift the MOVE/MOVE+ cart alone. When

moving the system over a door step or other unsmooth sur-

face, get assistance from another person to ensure stability.

• When moving the MOVE/MOVE+ cart across the floor,

maintain all its wheels in contact with the floor and ensure

that they are not locked.

• Always place the scanner in its intended mount on the

MOVE/MOVE+ cart when not in use and when moving

the MOVE/MOVE+ cart.

• Keep your feet clear of the MOVE/MOVE+ cart’s base

and wheels when moving the MOVE/MOVE+ cart.

• Never drag the MOVE/MOVE+ cart across any of its cables.

• Do not place the MOVE/MOVE+ cart on a slope greater

than 10 degrees.

• Keep sharp objects away from the touch screen.

System S3P (pod) only

WARNING

• Always place the scanner in its intended mount on the

pod when not in use.

• Do not place the pod on a slope greater than 5 degrees.

5.3 Explosion Hazards

Environment

WARNING

The TRIOS IOS system is not designed to be used in poten-

tially explosive environments, such as in close proximity

to flammable liquids or gases, or in oxygen-enriched

atmospheres.

Distance to the patient with anesthetic

WARNING

There is a potential explosion hazard if the TRIOS IOS

system is operated in the presence of flammable anesthetic.

ENGLISH

5.4 Electrical Safety

Ensure a grounded/earthed connection

WARNING

To avoid the risk of electric shock, the MOVE/MOVE+ cart

must only be connected to a supply mains with grounding/

protective earth. The MOVE/MOVE+ cart is equipped with

a three-pin (US: prongs) grounding/earth type plug. If you

cannot insert the plug into your outlet, contact your elec-

trician to replace the plug or outlet, to ensure a grounded

power connection. Do not try to defeat or ignore the

purpose of the grounding-type plug.

Electrical shock

WARNING

There is a risk of electrical shock if you attempt to access

the inside of any part of the system. Only authorized and

qualified service personnel may access the inside of any

part of the system.

Do not touch the electrical terminals

WARNING

The smart cord, the scanner tip, and the scanner tip inter-

face surface on the scanner contain electrical terminals.

For electrical safety, and to prevent corrosion and other

damages, the electrical terminals must not be touched at

any time, including touching electrical contacts and the

patient at the same time.

Do not use a power strip

WARNING

Do not connect the MOVE/MOVE+ cart to an ordinary power

strip or extension cord, because these may not be secure in

relation to grounding. If the ground connection fails, these

can cause the following hazards and potential injury:

- The total leakage current for all the connected equipment

can exceed the limits specified in EN (IEC) 60601-1.

- The impedance of the ground connection could exceed

the limits specified in EN (IEC) 60601-1.

Stress on cables

CAUTION

All externally connected cables (the power cable,

network cable, and the smart cord) must never

be subjected to pulling stress.

Spilled liquids

WARNING

Do not bring liquids, such as beverages, near the TRIOS IOS

system. Do not spill liquids on the TRIOS IOS system.

Condensation

WARNING

Variations in temperature or humidity may cause water

to condense inside the system, which can cause damage.

Always let the system reach room temperature before you

plug it into the power source.

If the system has been subject to major temperature or

humidity changes, wait till the system has reached room

temperature before plugging it into the power source.

If there is visible evidence of condensation, wait at least 8

hours before plugging it into the power source, to ensure

that no internal condensation occurs.

Disconnecting from mains

WARNING

There is no power ON/OFF switch on the system; therefore,

the only reliable means to disconnect the system from

mains is to unplug the power cord. Do not position the

system so that it is difficult to unplug the power cord.

Please allow enough time for the system to shut down

properly before disconnecting the power cord.

System S3P (pod) only: You must also disconnect

the PC from mains.

PC connection options and requirements

System S3P (pod) only

WARNING

The PC is a standard IT equipment certified to IEC 60950-1

and is located at least 1.5 m away from the patient. If you

choose this setup, you must not scan the patient and touch

the PC at the same time! You must not touch any periph-

erals connected with a cable to the PC while scanning a

patient. See the PC’s instructions for use for further details.

USB connection options and requirements

System S3A (MOVE/MOVE+ cart) only

WARNING

Only bus-powered USB devices without external power

supply that support USB Full speed mode must be con-

nected to the USB port.

ENGLISH

5.5 Eye safety

WARNING

The scanner emits bright light from its tip during operation.

The scanner complies with EN (IEC) 62471 (Photobiological

safety of lamps and lamp systems). However, we recommend

caution when handling the scanner.

A brief glimpse of the light into the eye is not dangerous,

but do not stare into the beam or view directly with optical

instruments, and do not aim the beam towards other

people’s eyes. In general, viewing bright light sources

(e.g. headlights), which have a high secondary exposure

potential due to their blinding effect, may cause temporary

reduction in visual acuity and afterimages, leading to irri-

tation, annoyance, visual impairment, and even accidents,

depending on the situation.

5.6 Hygiene

WARNING

To maintain a clean work environment and the safety

of the patient, wear clean examination gloves when:

• Handling the scanner tip – changing the tip, setting

the tip for upper/lower scans or handling the mirror.

• Handling the protection tip.

• Handling the color calibration kit.

• Applying TRIOS for scanning patients.

• Touching the TRIOS IOS system.

WARNING

Always clean the scanner unit and its optical window before

attaching the protection tip. Do not allow patient contact

with the protection tip.

WARNING

Always have the scanner tip mounted when you insert

the scanner into the patient’s mouth or when the scanner

comes in contact with the patient in any way. Mounting

of the scanner tip is always required for maximal electrical

safety and due to the risk of contamination.

WARNING

Always have a cleaned and sterilized scanner tip mounted

before attaching the color calibration adaptor. Do not

allow patient contact with the color calibration kit.

WARNING

Before each patient, you must:

• disinfect the system,

• apply a new sterilized or high-level disinfected tip to the

scanner.

See the detailed instruction in the chapter below.

System S3P (pod) only

WARNING

Before each patient, make sure any PC connected to the

system and its peripherals are disinfected. It is recom-

mended to use medical-grade peripherals (e.g., keyboards

and mice) that can be disinfected easily.

5.7 Safety when scanning with TRIOS

CAUTION

The handheld scanner is a highly precise optical instrument

and must be handled carefully. Do not drop, shake or bump

the handheld scanner, as these actions could cause it to break

or malfunction. Follow these guidelines:

• Always return the handheld scanner to its mount when

not in use.

• Do not submerge the handheld scanner in any liquids.

• Do not place the handheld scanner on heated or wet

surfaces.

• Grip the handheld scanner firmly during scanning

and when removing/returning it to its mount.

IMPORTANT NOTICE

The scanner will get warm during use. This is normal

but not part of any patient treatment.

CAUTION

The handheld scanner tip is fragile and contains a delicate

mirror. To avoid damage to the tip and mirror, take care not

to bump the tip onto the patient’s teeth or restorations.

CAUTION

When the TRIOS system is used for pediatric patients,

please pay extra attention while scanning the patient.

5.8 Protection from overheating

WARNING

The ventilation openings in the rear of the handheld

scanner must never be blocked or obstructed.

If overheated, the scanner may become uncomfortably

warm and eventually shut down.

System S3A (MOVE/MOVE+ cart) only

WARNING

Ventilation openings must never be blocked or obstructed.

There are openings at the back of the MOVE/MOVE+ cart

(behind the touch screen) and on the top and the bottom

of the base of the MOVE/MOVE+ cart. If overheated, the

system may stop functioning.

6. Cleaning, Disinfection,

and Sterilization

6.1 Cleaning, high-level disinfecting,

and sterilizing the scanner tip

The TRIOS scanner tip is the part of the scanner that is inserted into the

patient’s mouth during scanning. The tip can be reused a limited number

of times, but it must be cleaned and sterilized, or cleaned and high-level

disinfected, between patients to avoid cross contamination.

ENGLISH

Cleaning and sterilization procedure

Step 1: Clean the tip manually using soap water and a brush immediately

after use. A mild dishwashing detergent or similar is recommended.

Inspect the mirror of the tip after cleaning. If the mirror appears with

stains, smudged or with a milky haze, repeat cleaning using a soft dish

brush and soap water. Rinse with water. Dry the mirror carefully with

a paper towel.

Step 2: Put the tip in a sterilization pouch

The pouch should be sealed. Use either a self-adhesive or heat-sealed pouch.

Step 3: Sterilize the pouched tip in an autoclave with

one of the two programs*:

At 134 °C (273.2 °F) for a minimum cycle of 3 minutes.

At 121 °C (249.8 °F) for a minimum cycle of 15 minutes.

Use an autoclave program that dries the pouched tip before opening

the autoclave.

*Autoclave times and temperatures will vary depending on the type

and manufacturer of the autoclave. Please refer to the user manual

of the autoclave manufacturer to verify that the minimum autoclave

parameters are met.

Cleaning and high-level disinfection procedure

Step 1: Clean the tip manually using soap water and a brush immediately

after use. A mild dishwashing detergent is recommended. Inspect the

mirror of the tip after cleaning. If the mirror appears with stains, smudged

or with a milky haze, repeat cleaning using a soft dish brush and soap

water. Rinse with water. Dry the mirror carefully with a paper towel.

Step 2: Disinfect the tip using Wavicide-01 Solution

Immerse the tip completely in Wavicide-01 for 45 to 60 minutes.

See also the Wavicide-01 Solution instructions for use.

Step 3: Rinse the tip

After immersing the tip in the Wavicide-01 Solution for 45 to 60 minutes,

remove the tip and rinse it according to the Wavicide-01 Solution

instructions for use.

Step 4: Dry the tip

Use a sterile and non-abrasive paper towel or cloth to gently

remove remaining drops from the mirror and to dry the tip.

CAUTION

The mirror in the tip is a delicate optical component.

Its clean and undamaged surface is critical for the scan quality.

The mirror should be handled with care. Do not scratch it.

Be careful not to smudge it before scanning a patient.

CAUTION

Always clean the tip immediately after use. If biological

materials (bioburden) are allowed to dry on equipment,

disinfection and sterilization processes may not be effective.

CAUTION

Never autoclave a tip that is not pouched, since this will

leave unremovable stains on the mirror. See the autoclave

manual for more information.

CAUTION

New tips must be cleaned and sterilized/high-level

disinfected before using them for the first time.

CAUTION

A class B Vacuum autoclave according to EN 13060

is required for sterilization of the scanner tip.

CAUTION

The scanner tip can be re-sterilized up to 150 times and must

be disposed afterwards as described in section Disposal.

CAUTION

The scanner tip can be high-level disinfected up to 150

times with Wavicide-01 Solution and must be disposed

afterwards as described in section Disposal.

CAUTION

When high-level disinfecting the scanner tip using

Wavicide-01 Solution, there may be a visual change

to the tip after 70 disinfections. This change is only

visual and does not pose a risk.

IMPORTANT NOTICE

High-level disinfection with Wavicide-01 Solution as an

alternative to sterilization has been validated by 3Shape.

The Wavicide-01 Solution is not allowed and/or recognized

as a disinfectant of medical devices worldwide; always

follow procedures that have been established for your

clinic or institute, as well as any national guidelines.

IMPORTANT NOTICE

Always follow cleaning, disinfection and sterilization proce-

dures that have been established for your clinic or institute,

as well as national guidelines.

IMPORTANT NOTICE

If using Wavicide-01 for high-level disinfection, be sure

to follow the Wavicide-01 Solution instructions for use.

6.2 Cleaning, high-level disinfecting,

and sterilizing the calibration kit

The calibration adaptor must always be attached to a cleaned and sterilized,

or cleaned and high-level disinfected scanner tip, and must not have contact

with patients. If these instructions are not followed, the calibration kit must

be cleaned, high-level disinfected and sterilized.

Cleaning, high-level disinfection and sterilization procedure

Step 1: Disassemble the calibration kit (remove the sleeve from the cal-

ibration target and separate the calibration target from the calibration

adaptor).

Step 2: Clean the calibration adaptor manually using soap water and a

brush. Sterilize the cleaned calibration adaptor in an autoclave using

one of the programs listed for the scanner tip and using a sterilization

pouch (see section 6.1 Cleaning, high-level disinfecting, and sterilizing

the scanner tip).

Step 3: Clean the sleeve manually using soap water and a brush.

Disinfect the sleeve using the recommended disinfection solution listed

in section 6.3 Cleaning and disinfecting other parts of the system.

Step 4: The calibration target must only be cleaned with air. The calibra-

tion patches must not be touched and must not be exposed to liquids.

See the important notice below.

ENGLISH

After cleaning, high-level disinfection, and sterilization, the calibration kit

must be reassembled before use.

Ensure that all parts are dry before reassembly. If the kit is not used imme-

diately, place the calibration target in the sleeve and leave the calibration

adaptor in the sterilization pouch.

IMPORTANT NOTICE

The calibration target is a delicate optical component.

During disassembly and assembly of the calibration kit

only the end-part to the calibration target (opposite of the

calibration patches) must be touched, and the target must

only be cleaned with air.

6.3 Cleaning and high-level disinfecting

other parts of the system

After patient treatment, clean and disinfect all other surfaces

of the system (except the scanner tip and the calibration kit,

for which the previous sections apply).

Also note that the optical window is a delicate optical component and should

be handled with extra care during cleaning and disinfection (see below).

For general cleaning, a soft cloth and a mild detergent can be used.

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