The 3Shape TRIOS intraoral scanner (IOS) system is a medical device designed for dental professionals to perform and digitally save oral scans of patient's teeth for use in dental CAD/CAM systems. The system is manufactured by 3Shape TRIOS A/S, located at Holmens Kanal 7, 1060 Copenhagen, Denmark. It 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.
The TRIOS IOS system is available in several variants:
- S1P-2: Pen grip scanner, supplied with a pod (holder) that connects to an external PC via an Ethernet cable and a cord.
- S1P-4: Pen grip scanner (monochromatic variant), supplied with a pod (holder) that connects to an external PC via an Ethernet cable and a cord.
- S1A-10: Pen grip scanner, supplied with a MOVE® cart with built-in PC.
- S1A-12: Pen grip scanner (monochromatic variant), supplied with a MOVE cart with built-in PC.
- S1A-22: Pen grip scanner, supplied with a MOVE®+ cart with built-in PC.
All system variants include:
- Handheld TRIOS intraoral scanner (S1-2 or S1-4): A wired handheld dental intraoral scanner for scanning the surface of the patient's teeth, available in color (S1-2) or monochrome (S1-4).
- Scanner Tip (S-Tip) (S2): A re-usable scanner tip with a fixed window, which is the only applied part. It must be cleaned and sterilized before first use and after each use on a patient.
- Protection Tip (S-Ptip) (S3): Protects the optical window of the scanner from damage and dirt when not in use.
- Calibration Tip (S-Ctip) (S5): Used for calibrating TRIOS scanners.
- Color Calibration Kit (S-Ckit) (S6): Consists of a color calibration target (S7), a sleeve (S8), and a color calibration adaptor (S9).
- TRIOS software: Scan application/user interface for the scanner.
- Power (mains) cable and plug: Appropriate for the user's location.
Systems with a cart (S1A-10, S1A-12, S1A-22) additionally comprise:
- MOVE cart C 4.0 and MOVE+ cart C 4.1: For intraoral digital impression system.
- Adjustable monitor (S10, S11, S12).
- Scanner mount (S13): For holding the scanner when not in use.
- Wheels: For mobility, with brakes (S14).
- Computer unit: Attached to the cart for processing, storage, and running the TRIOS software.
- Touch screen: Touch-enabled screen for real-time display of scanning results and interaction with the software.
- System standby button (S15): On the back of the monitor.
- Scanner connection (S16): Under the low hinge on the back of the cart.
- Power socket (S18), network (LAN) connector (S19), and fuse drawer (S20): Located at the bottom (S17).
- USB license dongle and USB wifi dongle: Inserted in the top of the backpack (S21).
- USB port (only MOVE+): On the MOVE+ cart.
Important Technical Specifications
Light Source Specifications:
- The scanner emits bright light from its tip during operation.
- The product complies with EN (IEC) 62471 Photobiological safety of lamps and lamp systems.
- Users should not view directly with optical instruments, such as spectacle microscopes, and should avoid staring into the beam or aiming it towards other people's eyes.
Sterilization and High-Level Disinfection Method:
- Scanner tips can be autoclaved or high-level disinfected.
- A Class B Vacuum autoclave according to EN 13060 is required for sterilization of the scanner tip.
- The scanner tip can be re-sterilized or high-level disinfected up to 150 times.
- High-level disinfection with Wavicide-01 Solution has been validated by 3Shape as an alternative to sterilization.
Power Input:
- C4.0/C4.1 MOVE/MOVE+ cart (for S1A): 100-240 VAC, 50/60 Hz, 180 VA max, Insulation class: class I.
- S1-2 scanner: External class I medical power supply rated 30W max, 1.0 A.
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.
Storage Conditions:
- Ambient temperature range: -10 - +60 °C.
- Relative humidity: 10 – 85% (non-condensing).
- Atmospheric pressure: 800 - 1100 hPa.
Transport Conditions:
- Ambient temperature range: -10 - +60 °C.
- Relative humidity: 10 – 85% (Non-condensing).
- Atmospheric pressure: 620 - 1200 hPa.
Usage Features
Setting up TRIOS:
- Unpacking, assembly, and connection should ideally be performed by TRIOS authorized technical service personnel.
- If the system has been delivered from a cold environment, it should adjust to room temperature to avoid internal condensation and allow for proper calibration.
- All parts of the system should be examined for physical damage before use.
Scanner Tip Attachment/Removal:
- Place the tip over the front tube with the mirror facing upwards or downwards.
- Mount the tip in a linear direction until a mechanical click is felt.
- Remove the tip by pulling it away from the scanner body.
Calibration:
- Scanner Calibration: Required before first use and every 8 days during regular use, or after movement/temperature changes. Performed by placing the Calibration Tip on the Scanner Tube and following on-screen instructions in the TRIOS software.
- Color Calibration: Required before each scan for optimal colors. Involves attaching a cleaned and sterilized scanner tip, removing the sleeve from the color calibration target, mounting the target to the adaptor, and then attaching the adaptor to the scanner tip. Follow on-screen instructions in the TRIOS software.
Starting and Shutting Down:
- S1P (pod models): Start the PC, then the TRIOS software.
- S1A (cart models): Press the standby button on the top of the backside of the display; TRIOS software starts automatically.
- Shutdown: Click the Power button in TRIOS software and select Shutdown, or press the standby button on the back of the monitor (for cart models).
Maintenance Features
Cleaning, Disinfection, and Sterilization of Scanner Tip:
- Cleaning: Manually clean with soap water and a brush immediately after use. Rinse with water and dry the mirror carefully with a paper towel.
- Sterilization: Place the tip in a sealed paper sterilization pouch and autoclave at 134°C (273.2°F) for 3 minutes or 121°C (249.8°F) for 15 minutes (Class B Vacuum autoclave required).
- High-level Disinfection: Immerse the tip completely in Wavicide-01 for 45-60 minutes, then rinse and dry with a sterile, non-abrasive paper towel or cloth.
Cleaning, Disinfection, and Sterilization of Calibration Kit:
- Disassembly: Remove the sleeve from the color calibration target and disassemble the target and adaptor.
- Adaptor Cleaning/Sterilization: Manually clean with soap water and a brush, then sterilize in an autoclave using the same programs as for the scanner tip.
- Sleeve Cleaning/Disinfection: Manually clean with soap water and a brush, then disinfect using a recommended disinfection solution.
- Target Cleaning: Only clean the color calibration target with air. Do not touch calibration patches or expose them to liquids.
Cleaning and High-Level Disinfecting Other Parts of the System:
- After patient treatment, clean and disinfect all other surfaces (except scanner tip and color calibration kit).
- Use a soft cloth dampened with a disinfection solution (denatured alcohol/isopropyl alcohol/ethanol, typically 60-70% Vol.).
- Dry the optical window with a clean, soft, lint-free cloth.
- Do not submerge the scanner in cleaning solution, use ammonia/chloride-based solutions, or acetone. Do not spray liquids directly onto the system.
Additional Cleaning for Poor Scan Quality:
- If the tip mirror becomes unclean, remove the scanner tip.
- Apply alcohol (free of impurities) to a clean cloth or cotton-tipped swab and wipe the tip mirror until clean.
- Wipe the tip mirror dry with a dry, lint-free cloth.
Changing Fuses (S1A models):
- Shut down the cart and disconnect the mains power cable.
- Push in the two tabs on each side of the fuse drawer simultaneously to remove it.
- Replace fuses with the correct rating and type (250 V, T 3.15 A H).
- Reinsert the drawer until it clicks into place.
Changing Dongle (S1A models):
- USB wireless dongle, USB license dongle, and USB wifi dongle are located behind the plastic lid on top of the backpack.
- Remove the lid by opening screws.
Consumable Accessories:
- Scanner tips and calibration kits can be ordered from a 3Shape reseller when disposed of or needed.
Safety and Warnings
- General Safety: Read all instructions and warnings carefully. Proper functionality and safety depend on observing all safety precautions.
- Preventive Inspection: Examine the TRIOS IOS system for mechanical damage on enclosures and cables before use.
- Modifications: Modifications affecting safety are prohibited.
- Software: Only approved software should be installed.
- Training: Users must be trained and familiar with the documentation before using the equipment with patients.
- Equipment Failure: If the system malfunctions or is suspected to be faulty, remove the scanner from patient contact, unplug the system, and contact your reseller. Do not attempt to open covers.
- RF Communications: Portable RF communications equipment should be used no closer than 30 cm (12 inches) to the MOVE/MOVE+ cart system.
- Mechanical Hazards: Do not lean or sit on the system; movable parts can pinch.
- Dropped Equipment: If a scanner tip is dropped, dispose of it immediately. If the handheld scanner is dropped or bumped, calibrate it before further use. Examine for mechanical damage.
- Cart Movement (S1A models): Keep both hands on the upper part of the cart, ensure all wheels are in contact with the floor and unlocked, and get assistance for uneven surfaces. Keep feet clear of the base and wheels. Do not drag the cart by cables or place it on slopes greater than 10 degrees.
- Eye Safety: Do not stare into the scanner's bright light or view directly with optical instruments.
- Hygiene: Wear clean examination gloves when handling scanner tips, protection tips, color calibration kits, or applying TRIOS for scanning patients. Disinfect the system and apply a new sterilized/high-level disinfected tip before each patient.
- Overheating (S1A models): Ventilation openings must never be blocked.
- Stress on Cables: Externally connected cables must not be subjected to pulling stress.
- Spilled Liquids: Do not bring or spill liquids near the system.
- Condensation: Allow the system to reach room temperature before plugging it in, especially after major temperature/humidity changes.
- Explosion Hazards: Not designed for use in potentially explosive environments or in the presence of flammable anesthetics.
- Electrical Safety: Must be connected to a grounded/earthed supply mains. Do not use ordinary power strips or extension cords.
- PC Connection (S1P models): PC must be a standard IT equipment certified to IEC 60950-1 and located at least 1.5 m away from the patient. Do not touch the PC or peripherals while scanning.
- Power Supply: Only use the power supply delivered with the system.
- USB Service Connection (S1A models): Only connect bus-powered USB devices without external power supply.
Vigilance
In case of any serious incident, report to 3Shape at support@3shape.com and the competent authority.
Disposal
- Scanner Tip: Sterilize and dispose of as other clinical waste.
- TRIOS IOS System: Contact your 3Shape reseller for local requirements for disposal of electronic waste. The system follows the Waste Electrical and Electronic Equipment Directive (WEEE).
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