4
ENGLISH
WARNING
Use of the UNIT adjacent to or stacked with other equipment
should be avoided because it could result in improper
operation. If such use is necessary, the UNIT and the other
equipment should be observed to ensure normal operation
in the used configuration.
WARNING
The product needs special precautions regarding
electromagnetic compatibility (EMC) and needs to be
installed and put into service according to the EMC
information provided in the TRIOS Technical Data.
WARNING
Any person who assembles or modifies a medical electrical
equipment or system complying with the standard EN
(IEC) 60601-1 (safety requirements for medical electrical
equipment) by combining it with other equipment is
responsible for conducting appropriate inspection and
testing to ensure continued safe use of the equipment
and for ensuring that the requirements of this regulation
are met to their full extent for the safety of the patients,
the operators and the environment. Any use of accessory,
transducer, or cable of the system with other equipment
or systems than those specified may result in increased
emissions or decreased immunity of the system.
IMPORTANT NOTICE
The system is to be used in a Professional
Healthcare Environment.
4.2 Intended Use
The 3Shape TRIOS 3 Wireless 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. See the
online help for a list of supported indications.
CAUTION
Unintended use of the TRIOS IOS system can result in physical
injury to patients, operators and damage to the system.
4.3 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.
4.4 Contra-indications
None.
4.5 System Description
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.
S2P-2 Pen grip scanner, supplied with a pod (holder), 3 scanner
batteries and a scanner battery charger
S2A-10 Pen grip scanner, supplied with a MOVE® cart with built-in
PC, 3 scanner batteries and a scanner battery charger
S2A-18 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 (Figure 1 and 2):
• Handheld TRIOS intraoral scanner, S2-2 (S1): wireless handheld dental
intraoral scanner for scanning the surface of the patient’s teeth.
• Scanner Tip, S-tip (S2): Re-usable scanner tip attached to the handheld
TRIOS scanner. When the tip is detached, the scanner’s optical window
(S4) is visible. A set of scanner tips is delivered with the 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 is the only applied part.
• Protection Tip, S-Ptip (S3): Protects the optical window of the scanner
from damage and dirt when the scanner is not in use.
• Calibration Tip ,S-Ctip (S5): Used only for calibrating the scanner.
• Color Calibration Kit, S-Ckit (S6): Used for color calibrating TRIOS
scanners. The kit consists of the color calibration target (S7), the target
sleeve (S8) and the color calibration adaptor (S9).
• 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 3 batteries for the scanner, TB-02 or TB-03 (S10)
• A battery charger, C3BP with wall mount (S11)
System S2A 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+ carts:
• Has an adjustable monitor (S13, S14, S15).
• Has a scanner mount (S16) for holding the scanner while not in use.
• Has wheels for mobility (and brakes (S17) 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 (S18) is on the back of the monitor.
• In the bottom (S19), there is a power socket (S20), a network (LAN)
connector (S21), and a fuse drawer (S22). In the top of the backpack
(S23), 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 (Figure 3).