3Shape S3P-2 TRIOS Scanner Intraoral User Guide

3Shape S3P-2 TRIOS Scanner Intraoral

Product Information: 3Shape TRIOS

The 3Shape TRIOS is an IOS (Intraoral Scanning) system used in dentistry. This safety and setup guide provides important information on safety precautions, warnings, and considerations related to the TRIOS system. The guide also includes instructions for configuration and operation, which can be found in the online help system.

Manufacturer Information:

• Manufacturer: 3Shape TRIOS A/S
• Location: Holmens Kanal 7, 1060 Copenhagen, Denmark

To learn more about 3Shape and their products, as well as find global office locations, visit their website: www.3shape.com

If you need a printable version of this manual or a free printed copy, please contact 3Shape support via email at support@3shape.com.

IMPORTANT: It is crucial to observe all safety information and warnings provided in this guide to prevent personal injury, material damage, or damage to your TRIOS system. Safety information and warnings are highlighted using the words WARNING, CAUTION, or NOTICE.

The guide also includes labels and symbols with specific meanings:

• 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.

Product Usage Instructions: 3Shape TRIOS

Before assembling or using the TRIOS IOS system, carefully follow these instructions:

1. Read and understand the safety and setup guide provided in this manual.
2. Refer to the online help system for step-by-step instructions on configuration and operation of the TRIOS system.
3. Keep this safety and setup guide near the system at all times for quick reference.
4. Observe all safety information and warnings to prevent personal injury, material damage, or damage to the TRIOS system.

For further assistance or to request a printable version or printed copy of this manual, contact 3Shape support via email at support@3shape.com.

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

Conformity

This guide is published by 3Shape TRIOS A/S, who reserves the right
to improve and modify the contents without prior notice. Modifications will, however, be published in future editions. All rights reserved.
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.

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 .
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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 .
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**| 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 .

Legend of Labels and symbols

| Date of manufacture
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| Manufacturer
| General warning sign– caution (black on yellow)
| Type BF applied part
| WEEE Product disposal symbol
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| 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
| 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
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| Medical Device
| Global Trade Item Number
| Prescription Only (applicable for United States of America)
| Model Number

Description of TRIOS

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 .
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| 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 .
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| 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 .
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****| 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 .

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 physical injury to patients, operators and damage the system.

Users of TRIOS
The 3Shape TRIOS intraoral scanner system is to be operated by legally qualified 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.

Contra-indications
None

Patient Tar get Group
No restrictions in patient population

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
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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
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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 Smart Tip, 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.
• 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 devices as 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 .
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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

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 environment, let it adjust to room temperature to avoid internal condensation and to allow for proper calibration.

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 connection 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 .

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) .
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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 calibration. 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 .
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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 .
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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.

TRIOS System Environment

| IMPORTANT NOTICE
Operating Conditions
Ambient temperature range: +15 – +30 °C Relative humidity: 10 – 85 % (non- condensing) Atmospheric pressure: 800 – 1100 h Pa
The scanner should be used in an environment maintaining a consistent room temperature .
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| IMPORTANT NOTICE
Storage Conditions
Ambient temperature range: -10 – +60 °C Relative humidity: 10 – 85 % (non- condensing) Atmospheric pressure: 800 – 1100 h Pa
| IMPORTANT NOTICE
Transport Conditions
Ambient temperature range: -10 – +60 °C Relative humidity: 10 – 85 % (Non- condensing) Atmospheric pressure: 620 – 1200 h Pa

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 .
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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 regulations and the configuration of the product .)

Safety and Warnings

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 .
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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 .

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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 .

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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!
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Approved software only

****| CAUTION
Install only approved software – to prevent interference with the runtime reliability of the system and programs within it .
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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 .

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****| 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 .

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Portable RF communications equipment

****| WARNING
Portable RF communications equipment (including peripherals 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 performance of this equipment could result .
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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 .
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| 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 .

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 .

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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 .
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| 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 equipment failure (see this guide’s instructions on handling equipment failures) .
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| 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 .

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• 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 .

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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 .

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Explosion Hazards
Environment

****| WARNING
The TRIOS IOS system is not designed to be used in potentially explosive environments, such as in close proximity to flammable liquids or gases, or in oxygen-enriched atmospheres .
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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 .
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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 .
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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 .
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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 .
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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 .

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Stress on cables

****| CAUTION
All externally connected cables (the power cable, network cable, and the smart cord) must never be subjected to pulling stress .
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Spilled liquids

****| WARNING
Do not bring liquids, such as beverages, near the TRIOS IOS system . Do not spill liquids on the TRIOS IOS system .
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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 .
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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 .
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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 .
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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 .
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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 irritation, annoyance, visual impairment, and even accidents, depending on the situation .
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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 .

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| 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 recommended to use medical-grade peripherals (e .g ., keyboards and mice) that can be disinfected easily .
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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 .

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| 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 .

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 .
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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 .
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Cleaning, Disinfection, and Sterilization

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.

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 .
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| 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 procedures 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 .

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 calibration 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 calibration patches must not be touched and must not be exposed to liquids . See the important notice below .

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 immediately, 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 .
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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.

Recommended disinfection solution
Denatured alcohol (IPA – Isopropyl Alcohol or Ethanol) – typically 60-70% Vol.

To disinfect

Step 1 : Apply the disinfection solution to a soft, lint-free, non- abrasive cloth; the cloth must only be damp .

Step 2: Wipe the surfaces with the damp cloth .
Step 3 (optical window on scanner only): Dry the optical window with another clean, soft, lint-free, non-abrasive cloth .
| CAUTION
The scanner’s optical window is a delicate optical component . Its clean and undamaged surface is critical for the scan quality . The window should be handled with care .
Make sure it is free from lint, stains, and other kinds of dirt .
---|---
| CAUTION
Never submerge the TRIOS scanner into the cleaning solution .
| CAUTION
Do not use ammonia-based or chloride-based solutions, or acetone on any surface . Before returning the scanner to its holder, ensure both are dry .
| CAUTION
Do not spray directly onto any parts of the system, as the liquid solution can accumulate at the seals and leak into the scanner, monitor, PC, cords, or pod .
| IMPORTANT NOTICE
The scanner shell might get yellow-toned over a long period of use .
| IMPORTANT NOTICE
All surfaces that the protection tip comes in contact with, particularly the scanner tube and its optical window, must always be cleaned and disinfected before attaching the protection tip .

Additional cleaning in case of poor scan quality
During scanning, the tip mirror may become unclean, resulting in a loss of scan quality. In this situation, you can clean the mirror following these steps:

Step 1: Remove the scanner tip .

Step 2 : Apply alcohol to a clean cloth or cotton-tipped swab and wipe the tip mirror until it is clean . Use alcohol that is free of impurities, as those may stain the mirror . Ethanol or propanol (ethyl/propyl alcohol) can be used .
Step 3: Wipe the tip mirror dry with a dry, lint-free cloth to avoid leaving dust and fiber on the mirror .
****| CAUTION
Do not use acetone or any oxidizing solutions to clean the tip mirror .
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If you still see problems, check the scanner’s optical window for cleanliness, and apply the same procedure if necessary.

Disposal

| Described devices follow the Waste Electronical and Electronic Equipment Directive . The following symbol on the product, the accessories or packaging indicates that this device must not be treated as unsorted municipal waste, but must be collected separately! Please contact your 3Shape reseller, who can inform you about the local requirements for disposal of electronical, clinical waste . By disposing of the device in the proper manner, you help to avoid possible hazards for the environment and public health that could otherwise be caused by improper treatment of waste equipment .
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Disposal of the scanner tip
Sterilize the tip as described above.
The scanner tip contains electronics and must therefore be disposed
as both electronical and clinical waste. Please contact your 3Shape reseller, who can inform you about the local requirements for disposal of electroni-cal, clinical waste.

| CAUTION
Dispose the scanner tip as electronical, clinical waste .
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| CAUTION
The scanner tip must be sterilized before disposal .

Disposal of the TRIOS System
For disposal of the TRIOS IOS system, please contact your 3Shape reseller, who can inform you about the local requirements for disposal of electronic waste.

****| CAUTION
Batteries need to be removed and recycled or disposed of properly . See section 8 Technical Maintenance .
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Technical Maintenance

| CAUTION
All technical service and repair of the TRIOS IOS system must be performed by 3Shape or 3Shape-authorized personnel only .
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The user doesn’t need to perform any regular maintenance other than calibration, cleaning, disinfection and sterilization, as described here. Preventive inspections and scheduled maintenance are not required.
Scanner batteries need to be disposed of as lithium-ion batteries. Lithium-ion batteries are recyclable and must not be treated as unsorted municipal waste, but must be collected separately!
Battery Replacements

System S3A (MOVE/MOVE+ cart) only

Changing the fuses (Figure 2, S21)
Shut down the TRIOS MOVE/MOVE+ cart by following the procedure described in Setting up & Starting TRIOS for the First Time and disconnect the mains power cable from the TRIOS MOVE/MOVE+ cart.

****| CAUTION
The mains power cable must be disconnected before changing fuses .
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Using a pair of tweezers or similar, push in the two tabs on each side of the fuse drawer simultaneously, as shown in the picture S21. The drawer will begin to emerge from its slot.
It is then possible to remove the drawer and replace the two fuses.
Two spare fuses are provided with the system on delivery.

****| WARNING
Only fuses with the correct rating and type (250 V, T 3 .15 A H) must be used .
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To replace the fuses, first mount them in the drawer, then insert the drawer back into the slot and push all the way in until the tabs click back into place and the drawer is no longer loose in the slot. Do not attempt to insert the fuses directly into the slot on the MOVE/MOVE+ cart.
The mains cable can now be reconnected, and the TRIOS IOS system started up.

Changing the dongle for the MOVE/MOVE+ cart (software license protection):
The USB wireless dongle, the USB license dongle and the USB wifi dongle, and the Bluetooth dongle are located behind the plastic lid on top of the backpack of the MOVE/MOVE+ cart. You can remove the lid by opening the screws holding the lid, as indicated by the arrows in Figure 7.

****| WARNING
The scanner must not be operated while the ventilation grid on the back side of the MOVE/MOVE+ cart is removed .
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Consumable Accessories

The consumable accessories to the TRIOS IOS System are the scanner tips, the scanner batteries, and the calibration kit.
When the scanner tips are disposed, new tips can be ordered by contacting your 3Shape reseller. Also, a new calibration kit can be ordered from your 3Shape reseller.
If the system is supplied with batteries, new batteries can be ordered
by contacting your 3Shape reseller.

 Vigilance

In case of any serious incident that has occurred in relation to the use of the device, please report the incident to 3Shape at email: support@3shape.com and you can also report it to the competent authority of the state in which the user and/or patient is established.

Let’s change dentistry together

• 3Shape TRIOS A/S
• Holmens Kanal 7
• 1060 Copenhagen
• Denmark

More information at 3Shape.com

References

• Dental 3D Scanners & Software for CAD/CAM Dentistry | 3shape

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