Shining 3D Aoralscan 3 User manual

Aoralscan 3
Manual
V1.0.0.30

Aoralscan 3_Manual_V1.0.0.30 - 1 -
Foreword
General
The Manual (hereinafter referred to as "the Manual") introduces the functions, installation,
usage and maintenance of the Aoralscan 3 (hereinafter referred to as "the Scanner").
Safety Instructions
Signal
Meaning
Additional information for particular situation.
Improper actions or conditions that may damage the product or 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 in order 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
1
V1.0.0.30
Add various types of operational safety
precautions required by regulatory information.
August, 2021
2
V1.0.0.0
First release.
November, 2019
About the Manual
⚫Copyright © 2016 Shining3D Corporation. All rights reserved. No part of this publication
may be reproduced, transmitted, transcribed, stored in a retrieval system or translated
into any language or computer language, in any form or by any means, electronic,
mechanical, magnetic, optical, chemical, manual or otherwise, without the prior written
permission of Shining3D Corporation.
⚫All other logos, products, or company names mentioned in the Manual may be the
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,

Aoralscan 3_Manual_V1.0.0.30 - 2 -
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.

Aoralscan 3_Manual_V1.0.0.30 - 3 -
Table of Contents
Foreword...............................................................................................- 1 -
1. Read This First ............................................................................- 1 -
Basic Information .................................................................- 1 -
Intended Use .......................................................................- 4 -
Contraindications .................................................................- 5 -
Warnings .............................................................................- 5 -
Waste Electrical and Electronic Equipment .............................- 6 -
Disposal...............................................................................- 6 -
Warranty .............................................................................- 7 -
Contact Information .............................................................- 7 -
2. Safety Information......................................................................- 8 -
Precautions..........................................................................- 8 -
Legend of Labels and Symbols................................................- 9 -
2.2.1. On the Scanner ............................................................- 10 -
2.2.2. On the Scanner/Carry Box/Package................................- 10 -
Compliance........................................................................- 11 -
FCC Compliance Statement..................................................- 11 -
Electrical Safety..................................................................- 11 -
2.5.1. Electrical .....................................................................- 11 -
2.5.2. Classification................................................................- 12 -
2.5.3. EMC Notice..................................................................- 13 -
Biological Safety .................................................................- 20 -
Laser Protection .................................................................- 20 -
3. Unpack the Package..................................................................- 22 -
4. Overview .................................................................................- 24 -
Benefits of the Product .......................................................- 24 -
Scanner Overview...............................................................- 24 -

Aoralscan 3_Manual_V1.0.0.30 - 4 -
4.2.1. Scan head and scanner body .........................................- 24 -
4.2.2. Scanner Pedestal..........................................................- 25 -
4.2.3. Relay box.....................................................................- 25 -
4.2.4. Main Cables.................................................................- 26 -
Software Overview .............................................................- 27 -
4.3.1. System requirements....................................................- 27 -
4.3.2. Installing the software programs ...................................- 28 -
5. Setting the Scanner...................................................................- 29 -
Connecting the Scanner ......................................................- 29 -
Disconnecting the Scanner ..................................................- 30 -
Calibrating the Scanner .......................................................- 30 -
6. Scanning Preparations...............................................................- 33 -
Intraoral Environment.........................................................- 33 -
Scanner Preparation ...........................................................- 33 -
Scanning Position and Path..................................................- 33 -
Heating the Scanner Head ...................................................- 34 -
7. Clinical Case Quick Guide...........................................................- 36 -
Connect the Scanner...........................................................- 36 -
Activate the Scanner...........................................................- 36 -
Calibration.........................................................................- 36 -
Register Account ................................................................- 36 -
Create Orders.....................................................................- 36 -
Scan Upper Jaw ..................................................................- 37 -
Scan Lower Jaw ..................................................................- 38 -
Scan Total Jaws ..................................................................- 38 -
View Result Data ................................................................- 40 -
7.9.1. View Upper/Lower Jaw .................................................- 40 -
7.9.2. View Occlusal Effect .....................................................- 41 -

Aoralscan 3_Manual_V1.0.0.30 - 5 -
Pre-Design .........................................................................- 42 -
View Data Storage Path.......................................................- 42 -
Upload Order .....................................................................- 42 -
8. Care and Maintenance ..............................................................- 43 -
Pre-cleaning, Disinfection, and Sterilization...........................- 43 -
Scanner Pedestal Care.........................................................- 44 -
Scanner Body Care..............................................................- 44 -
Scanner Head Care .............................................................- 46 -
8.4.1. Cleaning and high-level disinfection ...............................- 46 -
8.4.2. Cleaning and steam sterilization ....................................- 48 -
8.4.3. Attaching the scanner head...........................................- 49 -
Scanner Storage .................................................................- 50 -
8.5.1. Storage for Transport ...................................................- 50 -
8.5.2. Daily and Long-term Storage .........................................- 51 -
9. Hardware Specification .............................................................- 52 -
Specifications.....................................................................- 52 -
Environmental Requirements ..............................................- 52 -

Aoralscan 3_Manual_V1.0.0.30 - 1 -
1. Read This First
The Manual provides important procedures and information on how to operate the scanner
and configure the IntraoralScan software correctly and safely. Before attempting to operate the
product, read the Manual and strictly observe all warnings and cautions. Pay extra attention to
the information from Safety information in chapter 2.
Basic Information
A. Product name, model
Product name: IntraoralScan
Model: Aoralscan 3
Name, residence, contact information and after-sales service of the registrant or the filer:
Registrant's name: SHINING 3D Tech Co., Ltd.
After-sales service provider: SHINING 3D Tech Co., Ltd.
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
Product performance, main structural composition
Product performance
- Appearance and structure
The appearance should be smooth, no cracks, no stains, no obvious deformation, flexible and
reliable operating mechanism.
- 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

Aoralscan 3_Manual_V1.0.0.30 - 2 -
as needed by using the relevant buttons on the top, bottom and right side.
- Performance
Posterior groove teeth scanning and imaging: Under normal operating conditions, the
scanner can scan and image human posterior alveolar teeth to form a 3D digital model.
Irradiance: Under normal use of the intraoral scanner, the irradiance is not greater than
1mW/cm2.
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 scanning head: 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 and .obj.
Main structural composition
The Scanner consists of Scanner body, scanner head, relay box, adapter, pedestal, USB cable,
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 relay box and scanner are
powered on. When the power is on, the relay box indicator is green.
Attention
⚫It is recommended that users copy the software from the USB flash drive to the
computer hard disk before installing the driver.
⚫Use Nvidia graphics cards to get the highest scanning efficiency.
⚫Do not insert wireless USB network card in the computer, USB wireless network card
will lead to USB bandwidth occupation, affecting the normal work of the camera.
VI. Product maintenance and care methods, special storage/transportation conditions,
operating conditions.
1) The product does not work in the state as far as possible not to open, the need for water
and moisture.
2) The need to use dustproof cover when sitting.

Aoralscan 3_Manual_V1.0.0.30 - 3 -
3) After using scanner head, use alcohol to wipe and then use autoclave to sterilize it. (121°C,
102.9kPa for 30 minutes; 134°C, 205.8kPa for 4 minutes). Use alcohol to wipe the scanner cover.
Use dust-proof cloth to wipe the scanning window to ensure the window keeps dry.
4) Operating temperature: 10°C to 40°C, relative humidity: 30%–75%.
5) Storage/transport temperature: -25°C to 60°C, relative humidity: 30%–75%.
6) Air pressure: 86 kPa–106 kPa.
Note
The temperature and humidity and atmospheric pressure conditions for
storage/transportation are reflected on the outer packaging.
VII. Production date, use by date or expiration date
The production date is shown on the product label. Use period: 8 years.
Eight, the list of accessories, including accessories, accessories, wear and tear replacement
cycle and instructions on how to replace.
Scan head as a wear and tear products can be autoclaved up to 20 times, after which it needs
to be replaced. Replacement method is as follows.
(1) Disconnect the scanner power, hold the scanning head firmly with thumb and index finger
on both sides, and then gently slide the scanning head out of the scanner as shown in the figure.
(2) Hold the scan head firmly with your thumb and index finger on either side and gently
attach the scan head to the scanner with the head facing down.
CAUTION
Do not place your fingers on the lens of the scan head when removing and attaching the scan
head, because this might cause damage to the lenses.
(3) Try to gently shake the scan head 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 intra-oral scanner.

Aoralscan 3_Manual_V1.0.0.30 - 4 -
The use of accessories and cables other than those specified may result in increased
emissions or reduced immunity of the Aoralscan 3 intraoral scanner, except for cables sold by the
manufacturer of the Aoralscan 3 intra-oral scanner as spare parts for internal components.
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. With Intraoral
Scanner, you can perform intraoral scanning directly and digitally acquire and save the 2D/3D color
images of a patient's teeth and gingiva for the orthodontic, implant, and restoration use. The
scanner kit is composed of: Scanner head, scanner body, pedestal, power adapter, USB cable, relay
box, USB flash drive (with IntraoralScan software inside, V1.0) and dongle.
Note:
⚫Benefits to be achieved: As a device that applies a probing optical scanning head, 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 mold
taking for patients, reducing stress for medical care, and improving efficiency for back-
end processing.
⚫The scanner satisfies related requirements.
WARNINGS
⚫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.

Aoralscan 3_Manual_V1.0.0.30 - 5 -
⚫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.
Warnings
Before using the Aoralscan 3, read these 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
pedestal. Water, moisture, etc. may cause a short circuit in the electronic components and lead
to malfunction.
⚫If the scanner head 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 pedestal. 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.

Aoralscan 3_Manual_V1.0.0.30 - 6 -
⚫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.
Waste Electrical and Electronic Equipment
Disposal of Waste Electrical and Electronic Equipment and by users in private households in
the European Union.
This symbol on the product or on the packaging indicates that this cannot be disposed of as
household waste. You must dispose of your waste equipment by handling it over to the applicable
take-back scheme for the recycling of electrical and electronic equipment and/or battery. For
more information about recycling of this equipment, contact your city office, the shop where you
purchased the equipment or your household waste disposal service. The recycling of materials will
help to conserve natural resources and ensure that it is recycled in a manner that protects human
health and environment.
Disposal
Caution
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.

Aoralscan 3_Manual_V1.0.0.30 - 7 -
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.
Contact Information
Manufacturer
Shining 3D Tech Co., Ltd
No.1398, Xiangbin Road, Wenyan, Xiaoshan, Hangzhou, Zhejiang, China
www.shining3d.com
Customer Support
Email: [e-mail]
Shining 3D’s Representative
Lotus NL B.V.
Address: Koningin Julianaplein 10,1e Verd,2595AA,The Hague, Netherlands.
Telephone: [phone]
Email: [e-mail]

Aoralscan 3_Manual_V1.0.0.30 - 8 -
2. Safety Information
Precautions
Warning
Follow the procedures carefully and ensure that the power/electrical/environmental
requirements are satisfied. 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 this 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 by following the instructions given in
Connecting the scanner in chapter 4.
⚫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

Aoralscan 3_Manual_V1.0.0.30 - 9 -
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 may
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 head immediately and do not
use the same head again. The mirror in the head 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, anduse of the scanner on patients
with pacemakers and ICDs is prohibited.
⚫Never place any objects or load on the scanner and its pedestal.
⚫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.
Legend of Labels and Symbols
The following symbols provide information on the product’s labels and regulatory compliance.

Aoralscan 3_Manual_V1.0.0.30 - 10 -
2.2.1. On the Scanner
Specification for scanner serial number
Serial number AOS3-AH001K13 represents the 001 product manufactured on November
13, 2018.
⚫AOS3……Stands for scanner model, abbreviation for Aoralscan 3.
⚫AH……Represents the year of production, A – J in alphabetical order stands for 1: 9
(Since letter I and number 1 are easily confused, ignore I), and 0 is represented by the
letter X.
⚫001……On behalf of the production flow number, unit 1.
⚫K……On behalf of the month, by letter A-M for 1-12 (Since letter I and number 1 are
easily confused, ignore I).
⚫13……Represents the date, expressed in 01 - 31.
Specification for serial number of calibrator
Serial number iCIII-AH001L05 represents the 001 product produced on December 05, 2018.
⚫iCIII......Represents the model of the calibrator.
⚫AH......Represents the year of production, A to J in alphabetical order stands for 1:9
(Since letter I and number 1 are easily confused, ignore I), and 0 is represented by the
letter X.
⚫001......On behalf of the offline water number.
⚫L ......On behalf of the month, by letter A-M for 1-12 (Since letter I and number 1 are
easily confused, ignore I).
⚫05......Represents the date, expressed in 01 - 31.
2.2.2. On the Scanner/Carry Box/Package
Labels and symbols on the carry box/package
Symbol
Explanation
General warning –caution.
Indicates that the device complies with requirements for the BF type applied part
according to IEC 60601-1, providing protection against electric shock.
Indicates that the contents of the transport package are fragile and therefore shall be
handled with care.
Indicates that the transport package shall be kept dry.

Aoralscan 3_Manual_V1.0.0.30 - 11 -
Indicates correct upright position of the transport package.
Indicates that the material shall be recycled.
Indicates the manufacturer information.
Indicates the product serial number information.
Indicates CE-related certification information.
Class II equipment.
Indicates laser information.
Indicates Shining 3D’s representative information.
Indicates that for more information, see use manual.
Compliance
Anyone creating or changing a medical electrical system through a combination with other
devices in accordance with standard EN 60601-1-1:2001 based on 60601-1-1:2000 (specification
for the safety of medical electrical systems)/UL 60601-1 Part 1: first edition 2003 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.
FCC Compliance Statement
This device complies with part 15 of the FCC Rules. Operation is subject to the following two
conditions: (1) This device may not cause harmful interference, and (2) this device must accept
any interference received, including interference that may cause undesired operation.
Electrical Safety
Only trained medical personnel should operate this scanner. The product complies with the
following standards.
2.5.1. Electrical
⚫IEC 60601-1-2: 2014 Medical electrical equipment Part 1-2: General requirements for

Aoralscan 3_Manual_V1.0.0.30 - 12 -
basic safety and essential performance-Collateral Standard: Electromagnetic disturbances–
Requirements and tests
⚫IEC 60601-1: 2015/A1: 2012 (ed 3.1) Medical electrical equipment –Part 1: General
requirements for basic safety and essential performance
⚫IEC 60601-1-6: 2013.Con Ed 3.1 Rev. October 29. 2013. Medical electrical equipment –
Part 1-6: General requirements for basic safety and essential performance –Collateral standard:
Usability
⚫IEC 62366-1: 2015 Medical devices–Part 1: Application of usability engineering to
medical devices
2.5.2. 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
WARNINGS
⚫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 head 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
or the cable is abraded.
⚫All devices connected to the Aoralscan 3 shall comply with IEC 60601-1 and IEC 60950.

Aoralscan 3_Manual_V1.0.0.30 - 13 -
⚫The radiation characteristics of the scanner are suitable for industrial and hospital use.
(CISPR 11 Class A). If the Aoralscan system is used in a residential environment (CISPR 11 Class B),
it may not adequately protect RF communications.
2.5.3. EMC Notice
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 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.
Guidance and Manufacturer's Statement - Electromagnetic emission
Aoralscan 3 is intended to be used in the following electromagnetic environment. The purchaser or
user of Aoralscan 3 should ensure that it is used in this electromagnetic environment:
Emission Measurement
Conformity
Electromagnetic Environment - Guidelines

Aoralscan 3_Manual_V1.0.0.30 - 14 -
RF emissions CISPR 11
Group 1
The Aoralscan 3 uses RF energy only for its internal
function. Therefore, its RF emissionsare very low and are
not likely to cause any interference in nearby electronic
equipment.
RF emissions CISPR 11
Class A
The Aoralscan 3 is suitable for use in all
establishments, including domestic establishments and
those directly connected to the public low-voltage
power supply network that supplies buildings used for
domestic purposes.
Harmonic emissions IEC
61000-3-2
Class A
Voltage fluctuations/flicker
according IEC 61000-3-3
Complies
Guidance and manufacturer’s declaration–electromagnetic emissions
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.
Guidance and Manufacturer's Statement - Electromagnetic emission
Aoralscan 3 is intended to be used in the following electromagnetic environment. The
purchaser or user of Aoralscan 3 should ensure that it is used in this electromagnetic
environment:
Immunity test
IEC 60601 test levels
Compliance level
Electromagnetic
environment–guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2
±8 kV contact
±2，±4，±8，±15 kV air
±8 kV contact
±2，±4，±8，±15 kV
air
Floors should be wood,
concrete or ceramic tile. If
floors are covered with
synthetic material, a
relative humidity of at
least 30% is
recommended.
Electrical fast
transient/burst
IEC 61000-4-4
±2 kV for power supply
lines
±2 kV for power supply
lines
Mains power quality should be
that of a typical commercial or
hospital environment.
Surge
IEC 61000-4-5
±0.5, ±1 kV line(s)
to line(s)
±0.5, ±1kV differential
mode
Mains power quality should be
that of a typical commercial or
hospital environment.