Aoralscan 3 - User Manual - V1.0.0.30
Aoralscan 3 - User Manual - V1.0.0.30
Aoralscan 3 - User Manual - V1.0.0.30
User Manual
XL/QER-RD-405
Foreword
General
The manual (hereinafter referred to as "the Manual") introduces the functions, installation,
Safety Instructions
Signal Meaning
Improper actions or conditions that may damage the product or cause injury, and
consequently void your warranty or service contract or lose the patient data or
system data.
The safety instructions that you must precisely follow to avoid injury. Failure to
observe can cause damages to your product, or result in personal injuries, or even
death.
Revision History
No. Version Revision Content Release Date
Add filled holes will be displayed in grey and
1 V1.0.0.30 (40) Dec., 2021
description.
2 V1.0.0.30 (30) Add regulation symbols and description. Nov., 2021
Add chapters of orthodontic simulation and oral
3 V1.0.0.30 (20) Oct., 2021
report.
Add operational safety precautions required by
4 V1.0.0.30 (10) Aut., 2021
regulatory information.
5 V1.0.0.0 First release. Nov., 2019
registered trademarks or copyrights of their respective companies, and are used for
informational purposes only.
Shining 3D Tech Co., Ltd. makes no representations or warranties, either expressed or
implied, with respect to the contents hereof and specifically disclaims any warranties,
merchantability or fitness for any particular purpose. Further, Shining3D Corporation
reserves the right to revise this publication and to make changes from time to time in
the contents hereof without obligation of Shining3D Corporation to notify any person of
such revision or changes.
Updates to hardware and/or software components are made regularly; therefore,
some of the instructions, illustrations, and specifications mentioned in the Manual may
differ slightly from your particular situation.
Table of contents
Foreword................................................................................................ - 1 -
1. Read This First ............................................................................ - 4 -
Basic Information ................................................................. - 4 -
Intended Use ....................................................................... - 7 -
Contraindications ................................................................. - 8 -
Warnings ............................................................................. - 8 -
Waste Electrical and Electronic Equipment ............................. - 9 -
Disposal ............................................................................. - 10 -
Warranty ........................................................................... - 10 -
2. Safety Information .................................................................... - 11 -
Precautions ........................................................................ - 11 -
Labels and Symbols............................................................. - 12 -
Compliance ........................................................................ - 14 -
FCC Compliance Statement.................................................. - 14 -
Electrical Safety .................................................................. - 14 -
Biological Safety ................................................................. - 22 -
Laser Protection ................................................................. - 22 -
3. Unpack the Package .................................................................. - 24 -
4. Scanner ................................................................................... - 26 -
Overview ........................................................................... - 26 -
Hardware Overview ............................................................ - 26 -
Software Overview ............................................................. - 29 -
5. Set the Scanner ........................................................................ - 31 -
Connect the Scanner ........................................................... - 31 -
Calibrate the Scanner .......................................................... - 32 -
Disconnect the Scanner ....................................................... - 34 -
6. Scanning Preparations ............................................................... - 35 -
Basic Information
I. Product name, model
Product name: Intraoral scanner
Model: Aoralscan 3
II. Name, residence, contact information and after-sales service of the manufacturer
Manufacturer name: Shining 3D Tech Co., Ltd.
Production Address: No. 1398, Xiangbin Road, Wenyan, Xiaoshan, Hangzhou, Zhejiang, China,
311258
The appearance should be: Smooth, no cracks, no stains, no obvious deformation. Flexible
and reliable for operation.
- Function control and display
Function control: After pressing the scanning button, determine whether the front end of the
scanner flashes normally.
Display: Under normal working conditions, when the scanner is opened for scanning, the two-
dimensional and three-dimensional imaging of the scanned object (such as teeth) can be seen on
the display respectively.
3D image processing: After the 3D stereo image is generated, the 3D image can be cropped
as needed by using the relevant buttons on the top, bottom and right side.
- Performance
Dental scan imaging: The scanner scans the teeth and gingiva to form a 3D digital model.
Irradiance: Under normal use of the intraoral scanner, the irradiance is not greater than
1mW/cm2 (Refer to IEC 62471:2006 Photo-biological safety of lamps and lamp systems.).
Accuracy: Under normal conditions, the scanner is used to scan against a standard (e.g., a
plaster standard known to be similar in size to a tooth), obtain its three-dimensional stereoscopic
data, and measure key dimensions to obtain measured values.
Heating of the entrance part of the scanner tip: Under normal working conditions, the
intraoral scanner should have heating and anti-fogging function when entering the mouth under
working condition.
- Data interface
USB 3.0, data storage format shall include 3D digital model format .stl, .ply and .obj.
Main structural composition
The Scanner consists of Scanner body, scanner tip, USB 3.0 repeater, power adapter, cradle,
USB cable, calibrator, software (V1.0), and encryption module. The software carrier is USB flash
drive, and the software release version is V1.0. After the power is switched on, ensure that the
USB 3.0 repeater and scanner are powered on. When the power is on, the USB 3.0 repeater
indicator is green.
Caution
It is recommended that users copy the software from the USB flash drive to the
computer hard disk before installing the driver.
Note
The temperature and humidity and atmospheric pressure conditions for
storage/transportation are mentioned on the outer packaging.
VII. The list of accessories, including accessories, wear and tear replacement cycle and
instructions on how to replace.
Scanner tip as a wear and tear products can be autoclaved up to 100 times, after which it
needs to be replaced.
(1) Disconnect the scanner power, hold the scanner tip firmly with thumb and index finger
on both sides, and then gently slide the scanner tip out of the scanner as shown in the figure.
(2) Hold the scanner tip firmly with your thumb and index finger on both sides and gently
attach the scanner tip to the scanner with the tip facing down.
Caution
Do not place your fingers on the lens of the scanner tip when removing and attaching the
scanner tip, because this might cause damage to the lenses.
(3) Try to gently shake the scanner tip to ensure that it locks into place and is stable.
Caution
The Aoralscan 3 intraoral scanner should not be used in close proximity or stacked with
other equipment, and if it must be used in close proximity or stacked, observe to verify
proper operation in the configuration in which it is used.
Class A equipment is intended for use in industrial environments where it may be
potentially difficult to ensure electromagnetic compatibility in other environments due
to conducted and radiated disturbances from the Aoralscan 3 intraoral scanner.
Using cables or accessories other than those specified for use with the scanner might
result in increased emissions or decreased immunity of the device.
Interruptions during electrostatic testing can be recovered within 5s without affecting
basic performance.
Intended Use
This is an intraoral scanner that works with the supplied software programs. By performing
intraoral scanning directly and digitally acquiring and saving the 2D/3D color images of teeth and
gingiva, the Scanner is available for patients with needs of orthodontic, implant, and restoration.
Note
Benefits to be achieved: As a device that applies a probing optical scanner tip, this
scanner can directly scan inside the patient's mouth to obtain three-dimensional
morphology and color texture information of soft and hard tissue surfaces such as
teeth, gums, and mucous membranes in the oral cavity, facilitating comfortable data
capturing for patients, reducing stress for medical care, and improving efficiency for
following processing.
The scanner satisfies related requirements.
Warning
Do not use the scanner for purposes other than those intended and expressly stated
above.
This product is designed and intended for use by persons with professions of dentistry
and dental laboratory technology. The product cannot be operated by the patients themselves.
The user is solely responsible for determining whether the scanner is appropriate for a particular
patient case.
Do not misuse the scanner, and do not use or operate the software programs incorrectly.
The clinical environments where the scanner and the software programs can be used
include dental clinics, dental hospitals, and dental laboratories.
Only trained medical personnel may use the scanner and the supplied software
programs. When under an adverse event, inform the relevant notified authorities and competent
authorities.
Installation, use, and operation of the scanner are subject to the law in the jurisdictions
in which it is used. Install, use, and operate the scanner only in such ways that do not conflict with
applicable laws or regulations, which have the force of law. Use of the scanner for purposes other
than those intended and expressly stated here, as well as incorrect use or operation, may relieve
us or our agents from all or some responsibilities for resultant noncompliance, damage, or injury.
The users of this scanner and software are responsible for image quality and diagnosis.
They should ensure that the inspection data is being used for the analysis and diagnosis only, and
furthermore the data is sufficient both spatially and temporally for the measurement approach
being used.
The images acquired by the scanner must be interpreted by a qualified medical
professional. The software in no way interprets these images or provides a medical diagnosis of
the patient being examined.
Contraindications
No known contraindications (or side effects).
Warnings
Before using the Aoralscan 3, read warnings and Safety information on chapter 2.
Do not attempt to disassemble, repair, or modify the scanner and software.
There are no user serviceable parts inside the scanner. Necessary modifications must be
made only by the manufacturer or its designated agents.
Do not allow foreign objects (including all types of liquids) to enter the scanner and its
cradle. Water, moisture, etc. may cause a short circuit in the electronic components and lead to
malfunction.
If the scanner tip is accidentally dropped to the ground, check to make sure the lens is
not loose before using it.
If the scanner is inadvertently dropped on the ground or impacted, it must be calibrated
before use. If there are still accuracy problems or scanning abnormalities after calibration, please
consult technical support.
Do not drop or apply shock/vibration to this scanner and its cradle. Strong impacts may
damage the components inside.
Do not cut, bend, modify, place heavy objects, or step on the cables. Otherwise, the
external insulation may be damaged and result in short- circuit or fire.
To avoid electrical shock, use only supplied power adapter and connect it only to
properly grounded wall outlets.
The device should not be used adjacent to or stacked with other equipment. If adjacent
or stacked use is necessary, the device should be observed to verify normal operation in the
configuration in which it will be used.
Disposal
The scanner must be reprocessed prior to disposal in order to prevent cross-contamination.
All electrical and electronic devices must be disposed of separately from your other
household waste in order to promote reuse, recycling and other forms of recovery, to prevent any
potential adverse effects of hazardous substances on the environment and human health, and
also to reduce the amount of waste in landfill. This includes accessories such as power adapters,
power cords, etc. Do safely dispose of the device and its accessories in accordance with applicable
laws and regulations.
For specific information on disposal of your device and the packaging, contact your local
distributor or service provider.
Warranty
The warranty is void if unauthorized personnel perform service or maintenance on the set of
Aoralscan 3. To ensure correct product performance and to obtain warranty service, contact
technical support.
2. Safety Information
Precautions
Failure to observe the instructions or disregard the warnings may result in damages to the
product, personal injury, or even death of the user or the patient.
Do not use the hardware and software for any application until you have read,
understood, and known all the safety information, safety procedures, and emergency procedures
contained in the chapter. Operating the hardware and software without a proper awareness of
safe use could lead to fatal damage to the hardware or permanent data loss.
Ensure that the connection is performed correctly. See 5.1 Connect the Scanner.
Use only medical grade devices with the scanner in the patient environment.
The hardware and software should only be used in a medical facility under the
supervision of trained personnel.
Only authorized service labs should perform maintenance. It is expressly prohibited to
open the scanner with tools.
The hardware and software have been fully adjusted and tested prior to shipment from
the factory. Unauthorized modifications will void your warranty.
If the hardware or software is modified, appropriate inspection and testing must be
conducted to ensure continued safe use.
Check the scanner and components for sharp edges.
Before use, check the device for damage, loose parts, wear and tear, and other cosmetic
problems. In case of such problems, please contact after-sales service.
During use, always pay attention to abnormal conditions of the scanner and the patient.
In case of abnormal conditions, you need to stop using it immediately. Consult technical support
staff promptly.
To ensure the performance and safety of the scanner, use only the original accessories
provided with the scanner (or accessories specified by Shining 3D, consult technical support for
details) and software.
Use only supplied accessories and approved software with the scanner in order to
achieve the designed performance.
Do not use a power adapter other than the one supplied with the package.
Connecting the scanner to an unknown power adapter is very dangerous and may lead
to fire or explosion.
Using cables or accessories other than those specified for use with the scanner might
result in increased emissions or decreased immunity of the device.
The supplied medical grade power adapter should only be connected to a grounded
power socket.
Reasonably arrange communication cables, power lines and other types of cables to
prevent users or patients from tripping over the wires. Do not forcibly pull or bend cables of any
kind.
The scanner is not intended for use in environments with high concentrations of
flammable liquids, gases, or atmospheric oxygen.
There is a risk of explosion when the scanner is used around flammable anesthetics.
Do not connect USB peripherals with an extended USB cable. Extended connection may
cause unexpected usage fault.
Always handle the scanner with care and avoid hitting or scratching the surfaces as it
contains fragile components. Dropping the scanner on the floor may cause permanent damage. If
you accidentally drop the scanner, you MUST dispose the scanner tip immediately and do not use
the same tip again. The mirror in the tip might shatter into small pieces, and using it again poses
the highest risk of causing serious injury to the user and patient.
The scanner might heat up to above the normal body temperature, yet this short- term
exposure and contact with small areas will not pose a health or safety hazard to the patient.
The scanner may interfere with pacemakers and ICDs, and use of the scanner on patients
with pacemakers and ICDs is prohibited.
Never place any objects or load on the scanner and its cradle.
Do not dispose the scanner as unsorted municipal waste. The scanner must be collected
separately and disposed of in accordance with the local laws and regulations. For proper disposal
of this scanner, contact your local representative of Shining3D Corporation.
Type BF applied part. To identify a type BF applied part complying with IEC 60601-1.
Indicates a medical device that can be broken or damaged if not handled carefully.
Indicates the manufacturer's serial number so that a specific medical device can be
identified.
Device fulfills the requirements of the European directives given on the EU Declaration
of Conformity.
Class II equipment.
Indicates the need for the user to consult the instructions for use.
Compliance
Anyone creating or changing a medical electrical system through a combination with other
devices in accordance with standard IEC 60601-1:2005+AMD1:2012 Medical electrical equipment
– Part 1: General requirements for basic safety and essential performance is responsible for
ensuring that the requirements of these standards are met to the full extent in order to ensure
the safety of patients, operators and the environment.
Electrical Safety
Only trained medical personnel should operate this scanner. The product complies with the
following standards.
Electrical
IEC 60601-1:2005+AMD1:2012 Medical electrical equipment – Part 1: General
requirements for basic safety and essential performance
IEC 60601-1-2:2014 Medical electrical equipment Part 1-2: General requirements for
basic safety and essential performance-Collateral Standard: Electromagnetic disturbances–
Requirements and tests
IEC 60601-1-6:2010+AMD1:2013 Medical electrical equipment – Part 1-6: General
requirements for basic safety and essential performance – Collateral standard: Usability
IEC 60601-1-9:2007+AMD1:2013 Medical electrical equipment–Part 1-9: General
requirements for basic safety and essential performance–Collateral Standard: Requirements for
environmentally conscious design
IEC 62366 2007+AMD1:2014 Medical devices–Part 1: Application of usability
engineering to medical devices
Classification
Type of protection against electric shock: Class II
The degree of protection against electric shock: Type BF
Enclosure protection: IPX0
Degree of protection against incoming liquids: Common device.
Level of safety when used with flammable anesthetic gas mixed with air or flammable
anesthetic gas mixed with oxygen or nitrous oxide: Non-AP/APG equipment.
The mode of operation: Continuous operation
Pollution degree 2
Warning
Shock hazards exist if the power adapter is damaged or is not properly grounded. Use
only the supplied medical grade power adapter.
To meet waterproof requirements, the sockets should not be placed on the ground.
Do not use grounding type plugs for other purposes.
Only authorized service labs can make internal replacements of the scanner and modify
the software.
Do not use the scanner if its tip or cable is damaged. Contact technical support for
replacement of the damaged equipment (see Contact information on chapter 1).
To avoid risk of electrical shock hazards, always inspect the scanner and cable
connections before use.
Check the cable housing before use. Do not use the scanner if the housing is damaged
Caution
Aoralscan 3 meets the EMC requirements.
Users should install and use the EMC information provided in the random file.
Aoralscan 3 might affect the performance of a portable or mobile RF communication
device. Avoid strong ELECTROMAGNETIC interference when using a scanner, such as
near a mobile phone or microwave oven.
The guidance and manufacturer's statement are shown in the attached table.
Warning
Aoralscan 3 should not be used in proximity to or on top of other devices. If it must be,
observe to verify that it works properly in the configuration in which it is used.
This device is not intended for use in residential environments, which may not provide
adequate protection for radio reception.
With the exception of cables sold by the manufacturer of Aoralscan 3 as spare parts for
internal components, the use of accessories and cables other than those specified may
result in an increase in transmission power or a decrease in immunity of Aoralscan 3.
Electromagnetic Emissions
Medical electrical equipment such as the Aoralscan 3 requires special precautions regarding
electromagnetic compatibility, and must be installed and put into service according to the
following electromagnetic tables.
The Aoralscan 3 is intended for use in the electromagnetic environment specified below. The
customer or user of the Aoralscan 3 should assure that it is used in such an environment.
Interference immunity
The Aoralscan 3 is intended for use in the electromagnetic environment specified below. The
customer or user of the Aoralscan 3 should assure that it is used in such an environment.
b
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
c
The ISM (industrial, scientific and medical) bands between 150 kHz and 80 MHz are 6.765 MHz to
6.795 MHz; 13.553 MHz to 13.567 MHz; 26.957 MHz to 27.283 MHz; and 40.66 MHz to 40.70 MHz.
To limit exposure to electromagnetic interference from nearby equipment that can degrade
image quality or launch warning messages, it is necessary to position the Aoralscan 3 further from
sources of electromagnetic interference or install electromagnetic shielding to block unwanted
interference. The customer or the user of the Aoralscan 3 should operate the device under EMI
conditions that minimize power supply transients, mechanical interactions, vibration, and thermal,
optical, and ionizing radiation.
Separation distances
The Aoralscan 3 is intended for use in the electromagnetic environment in which radiated RF
disturbances are controlled. The customer or the user of the Aoralscan 3 can help prevent
electromagnetic interference by maintaining a minimum distance between portable and mobile
RF communications equipment (transmitters) and the Aoralscan 3 as recommended below,
according to the maximum output power of the communications equipment.
The medical electrical equipment is suitable for the professional healthcare environment per
60601-1-2:2014. It is suitable for use in physician offices, clinics, hospitals, and other professional
healthcare environments except near HF surgical equipment and the RF shielded room of an ME
system for magnetic resonance imaging or other environments where the intensity of
electromagnetic disturbances is high.
The clinical environments where the device can be used include physician offices, clinics,
hospitals, and clinical point-of-care for diagnosis of patients except environments where the
intensity of electromagnetic disturbances is high.
Warning
Using cables or accessories other than those specified for use with the scanner might result
in increased emissions or decreased immunity of the device.
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
Aoralscan 3, including cables specified by the manufacturer. Otherwise, it could lead to
degradation of the performance of this equipment.
If immunity test level is higher than those specified in IEC60601-1-2, the minimum separation
distance may be lowered. Lower minimum separation distances shall be calculated using the
equation specified in IEC60601-1-2 Chapter 8.10.
Biological Safety
Meets biological criteria: ISO10993-5: 2009 (Biological evaluation of medical devices — Part
5:Tests for in vitro cytotoxicity); ISO10993-10: 2010 (Biological evaluation of medical devices —
Part 10: Tests for irritation and skin sensitization).
Laser Protection
This product is a class 1 laser product and is only for maintenance, replacement and removal
by professional personnel of the manufacturer or its designated agent (if necessary). If the device
is not used, removed or replaced as required, the normal use of the device may be affected and
laser radiation may occur. If a laser component is faulty, contact the manufacturer for help.
This product is a class 1 laser product according to "IEC 60825-1:2014 Safety of laser products-
Part 1: Equipment classification and requirements", without harmful laser radiation. Users will not
be exposed to laser radiation if they operate the equipment correctly according to the instructions.
Users should be aware of optical radiation protection. Bright light is projected from the
scanner tip during scanning. As with other light, there may be a temporary reduction in vision or
visual residuals. Do not look directly into the light projected by the scanner tip or shine the light
into the eyes of others.
Warning
AC plug types vary by country/region.
Using accessories, peripherals, or cables not supplied with the product or recommended
by Shining3D Corporation can affect the device in the form of increased emissions or decreased
immunity to external EMI/EMC occurrences. Non-specified peripherals, and cables in some cases,
can also increase leakage current or compromise the safety of the grounding scheme.
Using accessories or power supply units other than those specified may cause the
warranty to void and result in increased emissions, decreased EMI immunity of the device, or even
damages to the device and personal injuries.
Use of other accessories results in non-compliance.
Place the USB flash drive in a safe place for later usage.
Note
We recommend that you keep all the original packaging components in a safe place in case
you need to transport or dispose of the scanner in the future.
4. Scanner
Overview
The Aoralscan 3 is designed to provide powder-free intraoral color scanning with higher
speed, bringing greater accuracy and less time-lag for image acquisition. It can be used to scan a
single tooth, multiple teeth, and whole dental arches. The captured 3D digital images of teeth and
soft-tissue areas are designed to be used in conjunction with the supplied software programs.
Dental Order System Module, which helps manage the patient information and scanned records,
and Scan module, which assists you in acquiring digital images, and supports scan data export (in
STL/OBJ format) to CAD/CAM systems for different purposes of dental care.
Hardware Overview
Scanner Tip and Scanner Body
Scanner Cradle
Item Description
Scanner cradle When the scanner is not in use, place it on the cradle.
Note
If the scanner is idle for more than 1 minute, it will automatically enter the standby
mode. When the scanner is idle for more than 3 minutes (such as on the cradle), it will enter
the sleep mode, and the indicator on the scanner body will also be in the breathing light state.
As long as there is power connected to scanner, the scanner tip will be heated even
if the scanner is in standby or sleep mode.
USB 3.0 Repeater
Item Description
1. Power port.
USB 3.0 repeater
2. USB 3.0 Data cable. Connect it to your PC USB3.0
port.
USB cable storage 3. Connect the port to the scanner.
To prevent the USB cable from getting damaged by excessive bending or twisting, you should
loosely coil the cable and avoid making kinks or sharp bends.
Caution
Do not roll the cable over the handle of the scanner or even bend the cable sharply. The
illustration below demonstrates improper cable storage.
Main Cables
See the table for main cables.
No. Name Length (m)
1 Power adapter cable 1.5
2 USB 3.0 repeater data cable 1.0
3 Scanner connection cable 2.0
Software Overview
The Aoralscan 3 is designed to operate with the software programs, which include four
modules:
Calibration module
Calibrate the scanner.
Dental order system module
Designed to manage and store patient data, including cases, prescriptions, and restoration
information, realizing functions such as order creation, editing, searching, scanning and deletion,
as well as uploading, downloading, previewing and tracking of scanned order and data.
Scan module
The interface guides you through the entire scanning process of acquiring intraoral digital
images with the scanner.
Pre-design module
Mainly for users to be more convenient to use in the design software. Use the feature to
adjust coordinates, mark tooth position, extract margin lines.
System Requirements
Before installing and running the supplied software programs, your computer shall meet the
following requirements:
Memory 16 GB or higher
I/O ports More than 3 type-A USB 3.0 (or higher) ports
Note
Your PC shall meet the safety requirements of IEC 60601-1 and IEC 60950.
Caution
Install the software programs in accordance with the instructions given here.
When the installation is completed, do not plug the power adapter to the wall outlet or
turn on the scanner yet.
Follow the steps below to complete the installation of software programs:
(1) Insert the supplied USB flash drive into the USB port of your PC.
(2) Find the file named IntraoralScanX.X.X.X.exe and run it as administrator.
(3) The IntraoralScan Installation Wizard window appears to start the installation.
(4) Specify a language from the drop-down list.
(5) Click OK.
(6) Follow the on-screen instructions to complete the installation.
When done, an icon named after DentalLauncher will be displayed on your desktop for quick
access.
Caution
Ensure the supplied software programs are installed on your computer before the
connection.
If the accuracy of the equipment decreases or if the equipment does not work properly,
please consult technical support promptly.
Install the scanner in accordance with the instructions stated in the Manual.
Use the scanner only in dental laboratories, dental clinics, and equivalent environment.
Do not install, place, and use the scanner in dusty and damp environment or in the areas
of temperature extremes or in direct sunlight.
Prepare a flat surface, e.g. your desk, for the scanner and the cradle. Do not place them
on a slanted surface.
Before the installation is completed, do not plug the power adapter into the wall outlet
or turn on the scanner until you are instructed to do so.
Always hold the scanner firmly when lifting from the stand or when using the scanner.
Do not shake the scanner.
Always return the scanner to the cradle when it is not in use. Do not place the scanner
in heated or wet surfaces as this can cause damage to the scanner.
It is normal that the scanner gets warm when in use. Do not block the ventilation holes
on the bottom of the scanner. If the scanner overheats, the scanner will stop working.
Warning
Ensure that you use only the supplied power adapter, power cable, and USB cable.
Follow the steps below to complete the connection:
(1) Push the scanner tip hard to the scanner main body to ensure firm attachment.
(5) Click the shortcut icon of IntraoralScan on the desktop to launch the software.
Note
Do not place your finger(s) on the mirror of the tip when detaching as this may result in
damage to the mirror.
Store the detached tip in a safe place, e.g. a dental instrument tray, for future use.
Step 3 Connect the supplied calibrator and your computer with the supplied USB 3.0 cable.
Step 4 Gently slide the calibrator onto the front end of the scanner.
Step 6 Ensure the scanner is plugged into the calibrator firmly. Click Start. Calibration
begins.
Note
Normally the calibration takes approximately 7 minutes.
Step 7 The message prompting successful calibration appears once the calibration is
completed. Click OK to exit.
Step 8 Gently slide the Calibrator off the scanner.
Caution
Make sure that the Calibrator is removed from the scanner after the calibration is done.
Otherwise, the Calibrator temperature may get very high.
Step 9 Reattach the scanner tip to the scanner for later use or put the dust cap onto the
scanner to prevent damage and dust.
Caution
Do not attempt to directly disconnect the scanner by removing the power cable and USB
cable.
Do not roll the cable over the handle of the scanner or even create any sharp bends in
the cable after you disconnect the scanner.
Follow the steps below to safely disconnect the scanner:
(1) Quit the IntraoralScan scanning software.
(2) Disconnect the scanner USB 3.0 cable from the USB 3.0 repeater.
(3) Disconnect the other port of the USB 3.0 repeater from the computer.
(4) Right-click the “Safely Remove Hardware” icon on Windows taskbar and select “Eject Flash
Drive”.
(5) Unplug the USB flash drive and keep it in a safe place for future use.
(6) Unplug the power adapter from the wall outlet and remove the power plug from the
power connector on the cradle.
6. Scanning Preparations
Warning
Concerning hand hygiene and personnel safety when performing a scan, you must wear clean
surgical gloves through the whole process.
Intraoral Environment
Make sure there is no foreign body or blood in the mouth after gargling. Stop the
bleeding if necessary.
If necessary, ask the patient to keep the tongue still and move it to the other side of the
mouth.
Consider using a dental three-way syringe to blow dry or a tampon to dry the tooth
surface before starting the scan.
Turn off the oral light on the dental chair and start scanning.
Consider using aspirators and tampons to keep the surfaces dry during scanning.
If necessary, consider using an oral mirror to help create space while working in the
narrow area between the teeth.
Scanner Preparation
Ensure that the scanner tip, scanner body, and cradle are properly pre-cleaned,
disinfected, or sterilized. See Pre- cleaning, disinfection, and sterilization on chapter 10.
Ensure that the scanner tip has no scratches or is not damaged. Additionally, the tip is
firmly attached to the front end of the scanner body.
Ensure that the scanner connection is ready; it is correctly connected to a power source
and powered on, and IntraoralScan is launched and ready to work.
To avoid condensation on the mirror of the tip when scanning, the scanner tip must have
been warmed up. See 6.4 Heat the Scanner Tip.
Calibrate the scanner and verify the accuracy of the acquisition regularly. See 5.2
Calibrate the Scanner.
It the temperature of the scanner tip is lower than the set point for anti-fogging, a notification
message of pre-heating and current temperature appears.
When the message disappears, the warm-up is done. The scanner is now ready for an
acquisition.
Note
The heater helps keep the scanner tip temperature in a normal range.
The scanner tip is being heated whenever power is supplied, even if the scanner is in
standby or sleep mode.
If the heater does not reach the necessary temperature for preventing condensation
during scanning, the message of “The scanner is pre- heating. Please wait” appears.
7. Use IntraoralScan
Introduction to IntraoralScan
IntraoralScan includes four modules: Calibration module, dental order system, scan module
and pre-design module.
Calibration module is mainly used to calibrate the accuracy of scanner and ensure the
quality of scan data. It contains two functions which are brightness adjustment and
calibration.
Dental order system is a module for dental order management, realizing management
functions such as order creation, editing, searching and deletion, as well as uploading,
downloading, previewing and tracking of orders.
The scan module collects oral digital images, and exports 3D data (STL/OBJ/BEB (format
by Shining 3D)/PLY).
The pre-design module is mainly for the user to be more convenient to use in the design
software. Use the feature to adjust coordinates, mark the tooth position, and extract
margin lines.
Double-click to enter the login interface of the software. If you have registered an
account, you can use a password to log in.
Step 1 Enter the username: E-mail address, or mobile phone number.
Step 2 Enter your password.
Step 3 Select Remember password as needed to help log in quickly next time.
Step 4 Select Privacy policy.
Step 5 Click Sign in.
Double-click to enter the login interface of the software. If you have registered an
account, you can use a verification code to log in.
Step 1 Enter the username: E-mail address, or mobile phone number.
Step 2 Enter the numbers or letters in the image.
Step 3 Click send to send verification code to your E-mail or phone.
Step 4 Type the verification code.
Step 5 Select Privacy policy.
Step 6 Click Sign in.
Profile
Click in the upper right corner of the software to open the profile information.
The user information lists the contact, hospital/clinic, lab, phone and E-mail filled in when
registering the account.
Click Sign Out to exit the login of the current user.
Connections
Click in the upper right corner of the software to display the Connections interface.
Enter the name of the target lab in the edit box (fuzzy search available). Click check to confirm
the relationship and click cross to cancel.
Activate
When using the scanner for the first time, open the software and a message is displayed to
inform you that the scanner is not activated. You need to confirm activation—click Yes to open
the authorization tool, enter the organization name, name, mobile phone, and email, and click
Activate.
Online activation is recommended because you need to log in to the Internet to use the
software for the first time.
The steps for offline activation and offline validity extension are the same.
A message will be displayed indicating that the activation is successful.
Extend Authorization
After the scanner is activated, go to Settings -> About and select Apply for Authorization
Update to open the authorization tool. Both online extension application and offline extension
application are supported.
When the network is connected, online extension application is applied by default:
① Select the authorization period as required: 7, 15, 30, 90 and unlimited.
② Click Apply.
③ “Approving” is displayed after the remaining days, waiting for review.
④ After the after-sales technical personnel’s review, the review result will be automatically
updated when you open the software again.
Upgrade Software
Open "About" of scanning software and click "Check for Updates". If there is
updated installation package on the network, download the software.
If "Download updates automatically" is checked, the software will automatically
download the update package when the network is connected. When the download
is completed, an information box indicating whether to update immediately will pop
up:
Calibrate
After the installation of calibrator is completed, connect it to the scanner and
power on, click on the upper right corner of the software, then you can proceed
the next operation include brightness control and calibration.
Brightness Adjustment
Brightness adjustment is to correct the brightness of scanner and improve the
color fidelity of scan data. It is recommended to proceed the brightness adjustment
every 3 months.
Connect the scanner and calibrator correctly as shown, click Start to proceed
the brightness adjustment.
Calibration
The goal of calibration is to calibrate the accuracy of the scanner, ensure the
quality of scan data. The regular calibration is required which is recommended every
15 days.
Connect scanner and calibrator correctly as shown, click Start to proceed the
calibration.
After calibration finishes, calibration success or failure prompt interface is
displayed.
Order System
Order Settings
Parameter Description
Users can set the software interface language: Chinese
Language (Simplified), English and other languages. The default language
is the language selected during software installation.
Select a default dentistry type from Restoration and
Default Dentistry Type
Orthodontics.
FDI World Dental Federation notation and Universal numbering
Dental Notation
system. The default is FDI World Dental Federation notation.
Set the order saving path. The default is to save the DentalOrder
file in the installation package disk. If the installation package is
Order Save Path
stored in the C disk, the software installation path is
C:\DentalOrder.
To combine EXO software to IntraoralScan, enter EXO software
Exocad DentalCAD Path
location.
7.7.1.2. Naming Rules
Default naming rule is "Create date_Doctor Code_Order ID". Still, you can define your own
naming rule. Select wanted naming rules (order ID is a must) one after another and the final
naming will be displayed in earlier selected rule→later selected rule sequence.
7.7.1.3. Saved Format
Parameter Description
The exocad order *.dentalProject is saved while saving the order. You
Save EXO order can import the order into the EXO design software for design. The
default is on.
Save third-party software order when an order is finished. A third-
party software order is saved while saving the order. The folder named
"original order name_thirdParty" is generated under the order path,
Save 3rd party order and the *.xml file and the scanning result data *.stl/*.ply (the
coordinate system is consistent with the third-party design software)
are stored. You can create an order into a third-party design software
and import the data to design. The default is on.
Save dental wings A folder named after "original order name.xorder" will be generated
Create an Order
When creating an order, enter information of patients and doctors. Then select Dentistry
Type and teeth to be scanned.
Note:
When selecting Full Crown, you can select the Implant-Based type.
When two or more teeth are selected as Restoration type (full crown or
pontic), gray spots will appear between the two teeth. When the spots
turn blue, the bridge is shown.
Tooth
2
selection
Import Orders
Click Import order and select *.inProject or *.dentalProject file. Supports importing orders
saved by IntraoralScan software and ExoCAD orders.
When importing scanned orders and clicking Go to scan. The following prompt
interface is displayed:
To load the last scanned data, click Yes. To rescan, click No.
View Order
View created or imported orders in card or table mode on the software main interface. Click
or to switch the order display mode. Order information includes patient information,
order status, and creation time.
Double-click an order to enter the order information interface.
Note:
Under the table mode, settings before closing the software are saved.
Search an order: Enter the number or patient name in the search box to list the orders
that meet the conditions.
Filter orders: Click to expand the filtering criteria, which supports status, source
and time filtering.
Download the order data from the cloud platform to the local area.
Copy the currently selected order file and the scanned data to a new order.
Delete the currently selected order from the order list, and the user can choose whether
to delete the stored order files and scanned data.
Upload the currently selected order file and scan data to the Dental Cloud Platform.
Cancel an order that has been sent but not received, the action must be performed on the
order details page.
View Order Data
Cloud Platform Orders.
Cloud platform orders are orders with (under card mode), or orders with only
download operations in order list in table mode.
Cloud platform order data can be downloaded to local and can be browsed and edited.
Local order data.
*.dentalProject: exoCAD order project document
*.inProject: Shining 3D intraoral scanning order project document
*.stl: Untextured 3D data (binary)
Scan
After creating and saving an order in the Dental Order System, then you can scan target teeth.
If no scanner is connected, an error message appears to remind you to check and reconnect the
scanner.
Interface Introduction
Live image Screenshot: Take a screenshot of the current image in the image
3
window window, and save the image in the "EndoscopeImg" folder under the
current order directory.
11 Operation bar Edit: When this button is clicked, it enters the edit interface to
select the data to be deleted.
Part lock: When the scan is paused, click to set the scanning lock
area, and the data in the locked area will not change in subsequent
scans.
Undercut: The scan is paused and, when clicked, this button allows
you to view the dental undercut.
Switch Upper and Lower Jaw: Swaps the data from the upper and
lower jaws after the scan is completed or post-processing is
completed. For cases where the upper and lower jaw flow is reversed
during scanning.
Texture: Texture switch. Set whether the model data shows texture
or not. It’s checked by default to display textures.
Tooth color: Tooth color switch. Turn on the tooth color display. If the
gray color is displayed when scanning, it means the data quality in
these areas is not high enough, and more scans should be performed
in this area, and when the corresponding gray color becomes true
color display, it means the data quality has reached better post-
processing requirements.
AI Optimize: Apply to intraoral scanning. After clicking this button, the
intraoral scan automatically deletes miscellaneous data, such as
buccal and lingual data, soft tissue, etc. When you use the software
for the first time and enter the scanning interface, this button is
grayed out and you need to wait for 1–2 minutes for AI initialization,
after the initialization is completed, the button can be clicked.
View lock: When you click the button, the scanning is done with a
fixed perspective and the automatic perspective tracking function is
not enabled. Not enabled by default.
Metal tooth scan: When scanning metal teeth, click this button so that
it can improve the scanning speed and sweep the whole situation.
Swing the scanner up/down and left/right. Blue color indicates its in the selected state.
When the blue color fills up the whole button, the function will be triggered.
Icon Description
Next step.
Scanner connecting…
Scanner connected.
Scanner in standby.
Scanner overheating.
Scanner in sleep.
Note
If the scanner is not connected, a prompt is displayed to remind you to check and
reconnect the scanner.
If the scanner is connected and error prompts still appear, power off the base and then
power on again; If the software still does not detect the scanner, turn off the software,
wait a few seconds, and then restart the software.
Scanning Settings
Click and then click the Scan Settings tab to view or set scanning
parameters.
General
IMU menu: Motion sensing function. Enabled by default.
Auto-brightness: Adjust the camera brightness to capture clear images.
Enabled by default.
Refined scan: Unchecked by default. Suitable for refining the area by
selecting the prepared tooth area, post-processing data are processed more
finely to enhance data details.
Supports alternate day scanning: Enabled by default. Scanned orders
colour.
Camera
Camera top, bottom, left, and right margins’ values, they are acquired from the
camera by default; you can also manually set the cropping parameters for the top,
bottom, left, and right margins of the camera window, adjustable in the range of
[8,160].
Step 1 To enter the jaws scanning process, first check whether the image
display in the image window is normal or not.
Step 2 After confirming the image, click or press the space bar to start
scanning.
Note
The maximum number of frames for upper/lower jaw scanning is 3,000, and the
scan will be paused automatically for you to decide whether to stop scanning at 2,500
frames, and you can continue scanning for another 500 frames.
Step 3 Based on needs, click to enable tooth color. It will guide the
user to judge the reliability of the data quality in this area.
Note
If there is too much gray, scan the gray area again until it shows a normal tooth
color.
Display the tooth color (gray)
Note
The purple area in the camera window indicates that no data are scanned.
Mask
Step 5 Based on the needs, click button on the right, which will then
Step 6 During the scanning process, you can click the or press Space
key to pause the scanning, and delete the buccal and lingual data in the mouth during
the pause to facilitate the user to check the tooth scanning effect, as shown below
(images before and after pause)
Note
When the scanner tip leaves the object or the scanning is paused, the green
area means this area is not scanned. User can rescan the corresponding area
accordingly.
Scan paused (hole areas are in green)
Step 7 If the scan data is not satisfactory, you can rescan it. Click , and the
following prompt message box is displayed.
Click Yes to delete the previous data and restart the scan.
Step 8 After the scan or post-processing is completed, do not exit the scanning
interface and click scan button to add scanning.
Step 9 After confirming that the scan is completed, click the finish button or
long press the space bar to save the data. The green tick in the lower right corner of
the icon as shown below indicates that the scanning process is finished.
Scan completed
Unlock Features
7.8.4.1. Part Lock
Pause scanning of pre-operative upper and lower jaw or normal upper and
lower jaw, and then the part lock icon on the right side of the software can be
clicked.
Click to open the part lock interface and set the scanning lock area, thus
the data of the locked area will not change in subsequent scanning.
Confirm the lock area where the settings are saved and
Confirm
exit.
7.8.4.2. Edit Data
Data can be edited when upper/lower jaw scanning is paused, or after the data
processing of upper/lower jaw or upper/lower implant jaw is completed.
Click to enter the edit interface. The default selection button is brush.
Confirm Confirm the lock area where the settings are saved and exit.
7.8.4.3. Undercut
Undercut is used to calculate and view the undercut area of the marked
(corresponding part in the order) teeth.
When scanning the upper and lower jaw, pause the scanning to operate the
undercut feature on the right-side feature bar. Use the brush to select the undercut
range, and the undercut area is automatically calculated after the range selection is
completed.
The following figure shows the effect of the undercut display in a certain visual
direction:
Calculate the
Display the undercut effect.
undercut
Click Scan to open the scanning interface. The scanning process is: Pre-operative
upper jaw, upper jaw, pre-operative lower jaw, lower jaw and total jaw.
The default scanning sequence: Pre-operative upper jaw -> pre-operative lower
Jaw -> total jaw (scanning occlusion data) -> upper jaw > lower jaw -> total jaw
(automatic alignment).
Scan the lower jaw first (without intraoral scan body). After the lower jaw scan is
complete, the lower jaw implant scanning interface is displayed. Select the implant
area and delete it.
Select the implant area
Dig a hole
Click to enter scanning implant process (the scan body must be inserted in
the implant position before scanning).
Lock the lower jaw’s data (deep green), the unlock areas can be edited
On the interface of hole digging for implant jaw, users need to select the gingiva
data of all implant teeth and delete it. Then insert the first group of scan bodies to
scan. After the first group scanning is completed, click Pause, then click to
add another set of implant jaw scan.
Note:
If users move to scan the second group, the previous group data doesn’t support
further add-scan.
When you move to scan the second group, first group data is locked (in dark
green). During the process of scanning the second group, the data of first group won’t
be changed even when the scanner scan the locked area. If there are more groups
than two, do as what you do with first & second group.
Click the complete button and finish the implant jaw scanning case.
If the implant jaw scan is completed, you can add scan to the upper/lower jaw.
The implant jaw data can be imported with the following prompt window popping up.
Click or press the space bar to start scanning. After scanning some data,
the software automatically performs dynamic bite alignment.
Before alignment
After alignment
After the upper and lower jaws’ data are aligned successfully with the bite, click
or press the space bar to pause the scanning, check the occlusion results.
Click the finish button or long press the space bar to post-process the
data.
For the bite scan, you do not need to scan the entire jaws; you can just scan the
bite of anterior teeth in 1 step, or you can scan the bites of both left and right
posterior teeth in 2 steps (recommended), or you can scan bites for frontal anterior
and left and right posterior teeth in 3 steps. You can stop the scanning once the jaws
are aligned.
The maximum number of frames per step is 500 for the bite, and the software
will be forced to stop scanning when it reaches 500 frames.
Occlusion Preposition
Occlusion preposition is supported during scanning, i.e., the total jaw can be
scanned first.
Step 1 The total jaw scanning is completed. The total jaw icon is marked with an
exclamation mark, indicating there is already data for the total jaw but alignment
unfinished.
Step 2 Automatically skip to upper jaw. Scanning upper jaw is checked and
completed.
Step 3 Automatically skip to lower jaw. Scanning lower jaw is checked and
completed.
Step 4 Automatically align the total jaw (align successfully). Rescan the total jaw if
the auto total jaw alignment fails (marked with a red exclamation mark).
Pre-design Module
Pre-design function is added for you to easily apply the scanning data in the
design software. You can skip the process and upload orders directly.
Occlusion check: Adjust and view the occlusal gap between the upper and
lower jaws.
Extract margin line: Extract and save the margin line of the marked
(corresponding) teeth.
Check undercut: Calculate and view the area of undercut of the marked
(corresponding to the order) teeth.
AccuDesign: AccuDesign software implement operations such as "hollow",
"solid", adding drain hole and adding text labels to the model data obtained
by Shining 3D company.
Orthodontic simulation: Simulate orthodontic treatment solution, and view
the expected effect according to different treatment solutions.
Preview and Edit
Click to delete the smaller independent model data that are not
Remove isolated data connected to the main model data. Help delete unrelated model
data quickly.
Use the feature to make the model complete. Enable the feature
Fill holes to adjust the circumference of hole filling, and all holes within
the circumference will be filled.
Fit view Adjust the scanned data to the appropriate display size.
Adjust Coordinate
Click under the “pre-design” process to enter the interface. Position the
model in each of the three views with reference to the dental arch diagram and the
coordinate axes.
Reset: Cancel the current model position and reset it to the original model
position.
After adjusting the coordinates, click Go to send to upload data or implement
other operations.
Mark Teeth
Check Occlusion
Switch upper and lower jaws: Switch by clicking the upper jaw icon
parameters.
Click under the "Pre-design" process to enter the margin line extraction
interface.
Note
If you have ground the teeth, click to automatically extract the margin line.
The interface will automatically divide and extract the margin line of the spare tooth.
Sectional view : The curvature of the profile along the tooth surface
normal to the occlusion plane is displayed, and the effect is as follows.
Drawing line extraction : Long press the left mouse key to draw a line,
and release the mouse to extract part of the margin line, each drawn line is
automatically connected with the previous one, and finally a closed margin
line is extracted.
Note
Line segment extraction is a complementary tool for magnetic extraction,
suitable for teeth with no clear margins.
segment between the first two control points will not change again, repeat
the above steps before you set the final control point to overlap with the
first one to form a closed margin line by double clicking. When the magnetic
suction function is off, a straight line will be created between the current
mouse position and the previous control point (i.e. line segment extraction).
Magnetic suction extraction is suitable for teeth with clear margins.
Step 3 Edit margin lines to make them closer to tooth edges.
Draw line extraction mode : The newly drawn line replaces part of
originally extracted margin line.
Check Undercut
Click on the right side of the software to open the undercut interface.
You can rotate the model to the appropriate view, double-click the view or click
to recalculate undercut area.
AccuDesign
No. Description
The upper and lower jaw number. The marked teeth is with white background
1 labels; If the tooth position is not identified or has no teeth, it is with blue
background label.
2 Displays the number of marked tooth positions. And distinguish each tooth by
different colors.
Click the tooth number to delete, modify the number, edit the tooth area and adjust
the frame.
Note
If you have created the model, then you can switch to the Modeling interface
through the navigation bar.
Note
If you have set the teeth, you can switch to the Tooth setup interface by the
navigation bar.
Collision detection: Collision detection can detect the results after tooth
setup, and can detect the collision between the upper jaw and the lower jaw.
It helps understand the occlusion situation, and deal with complex
malocclusion cases.
Before and after orthodontic: Compare the effect before and after
orthodontic. Patients can understand the treatment effect better.
Animation: Play back the whole process of orthodontic treatment. Click Video to
export and save the animation.
Export: You can export the upper and lower jaw from different perspectives, and
nine expected images in the treatment process. Click Picture on the left to export the
simulated orthodontic pictures of the upper and lower jaws; Click Picture on the right
to export the nine images during the treatment.
QR code: Click QR Code to generate a QR code. Use a phone app with QR
scanning feature to scan the QR code and check the user's treatment process
information.
Oral Report
When creating a new order, select the Dentistry Type as Check to generate a report
on the pre-design interface. It is convenient for doctors to understand patient
treatment information.
6. Click .
7. Click .
Model screenshot:
7. Click .
8. Repeat Step 2 to 7 to take multiple screenshots of the treated teeth.
9. Click .
Select the path of DentalDB (supporting Chairside 2.1, exocad 2018, 2019 and 3.0),
and click Bind, and when Bind Scanner Succeed pops up, it is indicated that the
binding is successful.
Start the DentalDB program, create an order, save and scan.
Start the scanning software for scanning and data processing. After the data
processing is complete, click Go to Send to open the send interface, and select the
target lab to send.
Case Workflow
1. Labs register as a lab account on the website and log in.
2. Doctors register as a doctor account on the website and send a request to the
labs to establish a network. And then the status of the connection is Order Taking
Awaited.
3. Labs accept the request, then the status of the connection is “Active”.
4. Doctors open the IntraoralScan software, go to Setting->Set account in dental
order system, enter the account name and password to log in. After the scan data
processing is completed, the doctor can upload the data.
5. Labs can download the data on website.
Register an Account
It is recommended to open the dental cloud website using browsers such as
Chrome, Firefox, and Safari.
After the registration is successful, it will get back to homepage. Enter the
mailbox or mobile phone number and password to log in to cloud platform. The
hospital, clinic and doctor's account can establish a network connection with a lab.
Account Management
After logging in to your account, click the Account on the upper right corner. Then
select Account Setting from the drop-down list.
Manage Institutions
Only the account that is authorized can have the access to manage institutions
member and information.
Institution Member Management
On the Members interface, you will find:
Case Management
Preview and Download Case
After logging in to the account, the Cases interface is displayed by default.
② Messages: For each order, dentist and lab can have chats on the webpage.
You can click it to send messages as below picture shows. You can send texts
and files.
⑤ Preview: Click “Download” on the “Cases” interface, click “Preview” and the
following interface is displayed. You will find all the scan data from this order.
You can click right button of the mouse to rotate the scan data. You can check
different scan data on the left panel.
Search: You can type in doctor name, account, hospital name, lab name,
patient info in ①, and select the restoration type from the drop- down list
②, and select the upload date in ③, then click Search to check the required
order list.
Reset: You can click Reset to clear all filter requirements and then a list of all
orders is displayed.
Warning
All parts are shipped non-sterilized. Follow the instructions prior to initial use.
Ensure that you have completely disconnected the power supply and all connections
from the scanner.
Follow the instructions given in the Manual to pre-clean, disinfect, and sterilize each
part of the scanner. Using other methods not approved by Shining3D Corporation will damage
your scanner and void your warranty.
Using detergent, disinfection solutions or wipes, sterilization procedures other than
those specified in the Manual may damage the product and void your warranty.
Only sterilize the part(s) for which a sterilization method is specified. Do not attempt to
sterilize all parts of the product. Shining3D Corporation is not liable for any damages due to
improper sterilization.
After sterilization, wait until each of the parts is at room temperature to prevent
possible heat injuries to the user and the patient.
To prevent cross-contamination, pre-cleaning, disinfection, and sterilization must be
correctly performed after each use.
When the scanner tip is detached from the scanner, always protect the subtle units and
the inner optical components on the front end of the scanner body by putting on the supplied
dust cap.
Warning
Concerning hand hygiene and personnel safety when performing pre- cleaning and
disinfection/sterilization, you must wear clean surgical gloves before you start.
Always ensure that you have pre-cleaned and disinfected/sterilized the scanner body,
scanner cradle, and scanner tip before each scan.
The caring methods for the scanner cradle, scanner body, and scanner tip are different
and must be executed separately. Before disinfecting the scanner body, you shall start with the
cradle first.
Ensure that the scanner tip is detached from the scanner, and the dust cap is put on the
scanner when disinfecting the scanner body.
Follow the steps below to complete the disinfection:
(1) Disconnect the power of the Aoralscan 3 (see Disconnecting the scanner on chapter 4).
(2) Hold the scanner tip firmly with your thumb and forefinger on both sides, and then gently
slide the tip off from the scanner.
Note
Do not place your finger(s) on the mirror of the tip when detaching as this may result in
damage to the mirror.
(3) Store the detached tip in a safe place, e.g. a dental instrument tray, prior to disinfecting
the scanner body.
(4) Hold the supplied dust cap with the triangle mark facing upward. Then, align the dust cap
blocks to the matching slots on the front end of the scanner body.
(5) Slide the dust cap onto the scanner to prevent damage and dust.
Caution
When the scanner tip is detached, always protect the subtle units and the inner
optical components on the front end of the scanner by putting on the supplied dust
cap.
Do not attempt to clean the outer units and inner optical components on the front
end of the scanner with any sharp objects or other such tools, which may result in
scratches and damage to the scanner.
(6) Hold the scanner body with your hand.
(7) Use new cotton gauze moistened with 70%-75% solution of ethanol to wipe the surface
of scanner body.
Caution
Avoid using detergent of any kind as some detergents or surfactants might
penetrate the surface of the scanner body.
Do not clean the intake and exhaust vents with any sharp objects or other such
tools.
(8) When done, store the scanner body in a clean and safe place.
(9) Proceed to the cleaning, disinfection or sterilization of the scanner tip.
Warning
Concerning hand hygiene and personnel safety when performing cleaning and
disinfection/sterilization, you must wear clean surgical gloves and goggles before you start.
Cleaning the scanner tip is an essential step before effective disinfection or sterilization.
When inserting the scanner tip into the disinfectant solution, be sure to follow the
instructions on the disinfectant label and limit the time and depth that the tip is soaked within the
minimum time recommended.
The scanner tip can be sterilized under high temperature up to 100 times and must be
disposed of afterwards. For more information on disposal, see Disposal on chapter 1.
High-level disinfection and steam sterilization must NOT be combined.
Apply only either of these methods to ensure the safe and effective reprocessing of the
scanner tip, and thus to prevent damage of reusable tip.
Two effective and approved methods of cleaning and disinfection/ sterilization are
recommended and described as below.
Either should be used to reprocess the scanner tip between each patient contact:
Cleaning and High-level Disinfection
Follow the steps below to perform cleaning and high-level disinfection:
(1) Disconnect the power of the Aoralscan 3 (see Disconnecting the scanner on chapter 4).
(2) Hold the scanner tip firmly with your thumb and forefinger on both sides, and then gently
slide the tip off from the scanner body.
Caution
Do not place your finger (s) on the mirror of the tip when detaching as this may result in
damage to the mirror.
(3) Pay particular attention to inspect the mirror of the tip to ensure that the mirror is not
cracked or broken and there is no scratch on it.
Caution
If the mirror of the tip has cracks or scratches, stop the cleaning process and contact your
local distributor or service provider.
(4) Gently clean the inner and outer sides of the tip using mild pH-neutral soap water and a
soft brush for 3 minutes.
When cleaning the inner surface of the tip, insert the soft brush into the tip from
both the front and rear ends, and move the brush lightly in tiny circles.
When cleaning the outer surface of the tip, move the brush lightly back and forth,
and repeat for each side.
(5) Repeat the previous step for at least two times.
(6) Rinse the tip thoroughly with sterile water.
(7) If you notice stains, fingerprints, or smears on the mirror surface, repeat the previous step.
(8) Dry the tip carefully with a clean, soft lens tissue or lint-free cloth.
(9) Pay particular attention to inspect the mirror surface of the tip again to make sure that
the cleaning is done properly and the mirror is not damaged during the cleaning process.
(10) Carefully fill the container with a disinfectant solution, such as phthalaldehyde at a
concentration of 5.5g/L (depending on the brand of disinfectant used). In the event of a leak,
Caution
Discard the rinse water. Always use fresh volumes of sterile water for each rinse. Do not
reuse the water for rinsing or any other purpose.
(16) Repeat the rinsing process (step 12 to 15) for at least two times for removing the residue
of disinfection solution.
(17) Use a soft lint-free cloth to dry the tip.
(18) Pay particular attention to inspect the mirror surface of the scanner tip again to make
sure that the disinfection is done properly and the mirror is not damaged during the disinfection
process.
(19) Re-attach the scanner tip (see 10.3.3 Attach the Scanner Tip). Or if you attempt to store
the scanner tip with other dental instruments, e.g. a dental instrument tray, ensure that it is
thoroughly dry.
Cleaning and Steam Sterilization
Follow the steps below to perform cleaning and steam sterilization:
(1) Disconnect the power of the Aoralscan 3 (see 5.3 Disconnect the Scanner).
(1) Hold the scanner tip firmly with your thumb and forefinger on both sides, and then gently
slide the scanner tip off from the scanner.
Caution
Do not place your finger(s) on the mirror of the tip when detaching as this may result in
damage to the mirror.
(3) Hold the supplied dust cap with the triangle mark facing upward. Then, align the dust cap
blocks to the matching slots on the front end of the scanner body.
Caution
If the mirror of the tip has cracks or scratches, stop the cleaning process and contact your
local distributor or service provider.
(4) Gently clean the inner and outer sides of the tip using mild pH-neutral soap water and a
soft brush for 3 minutes.
When cleaning the inner surface of the tip, insert the soft brush into the tip from
both the front and rear ends, and move the brush lightly in tiny circles.
When cleaning the outer surface of the tip, move the brush lightly back and forth,
and repeat for each side.
(5) Repeat the previous step for at least two times.
(6) Rinse the tip thoroughly with sterile water for at least 3 minutes.
(7) If you notice stains, fingerprints, or smears on the mirror surface, repeat the previous step.
(8) Dry the tip carefully with a clean soft lens tissue or lint-free cloth.
(9) Pay particular attention to inspect the mirror surface of the scanner tip again to make
sure that the cleaning is done properly and the mirror is not damaged during the cleaning process.
(10) Fill the scanner tip lens with medical gauze.
(11) Put the wrapped scanner tip into an autoclave and sterilize it for 30 minutes at 121°C (or
4 minutes at 134°C). For the specific sterilization pressure, refer to the instructions of the
autoclave (102.9kpa at 121°C is recommended; Or 205.8kPa at 134°C).
(12) Dry the sterilized tip for 30 minutes with the autoclave program before opening the
autoclave.
(13) Reattach the scanner tip.
Attach the Scanner Tip
There is a risk of damaging the mirror of tip if any improper actions are taken when attaching
the tip to the scanner.
Warning
Wear clean surgical gloves before you start.
Ensure that the scanner cradle, scanner body, and scanner tip are pre-cleaned and
disinfected/sterilized (see Scanner body care on chapter 10 and Scanner storage on chapter 10).
Follow the steps below to complete the attachment:
(1) Hold the scanner tip firmly with your thumb and forefinger on both sides, and then gently
attach the tip facing downward to the scanner.
Caution
Do not place your finger(s) on the mirror of the tip when attaching as this may result in
damage to the mirror.
(2) Try swiveling the scanner tip around to ensure it is locked into position and stable.
(3) Place the scanner in the cradle, and the set is ready for use.
Scanner Storage
In case you need to transport the device, we strongly recommend that you keep the original
packaging after unpacking the Scanner. Shipping the device without its original packaging material
may cause possible product damage and result in additional service fees.
If the original packaging is no longer available or damaged, carefully package each part of the
scanner with bubble wrap to protect against any possible damage during transportation.
Storage for Transport
Make sure that the scanner is clean before placing it in the original carry box/package