Dental Wings 100 User manual

dental wings
Intraoral Scanner
Instructions for Use
Original
Model 100 Model 001

CONTENTS
1. About this guide 4
1.1 Disclaimer 4
1.2 License, trademarks and other rights 5
2. Introduction and overview 7
2.1 Intended use 7
2.2 Device description and features 7
2.3 Accessories and products used in combination 8
2.4 Indications 9
2.5 Precautions 9
2.6 Compatibility information 11
2.7 Data protection 11
2.8 Further information 12
2.9 Disposal 14
3. Installation 16
3.1 Unpacking the scanner 16
3.2 Setting up the scanner 17
4. Basic principles and user interface 23
5. Scanning 28
5.1 Accuracy 28
5.2 Step-by-step 28
6. Maintenance 32
6.1 Handling 32
6.2 Reprocessing 33
6.3 Data backup 34
6.4 Changing fine fuses 35
6.5 Service 35
7. Troubleshooting 37
8. Packing the scanner 40
9. Distributors and service 42
10. Technical data and label 43
11. Explanation of symbols 49
Appendix A - Reprocessing of the handpiece sleeve 51
Appendix B - Reprocessing of the Intraoral Scanner (without handpiece sleeve) 56
Appendix C - Electromagnetic Compatibility Guideline 60

1. About this guide
 Caution
The provided instructions contain important information on the safe and appropriate use of your
scanner and its software. Make sure to have read and understood this document prior to installing
and operating the device.
These Instructions for Use are valid for the product life cycle of your device and its software unless new
instructions are published within this period. In case of questions, contact your local distributor. Please
keep this document for future reference.
The term "scanner" refers to any and all Intraoral Scanner models, including their parts and accessories.
The term "scanner unit" refers to the scanner component used to process scans. The term "handpiece"
includes both the handpiece and its sleeves.
Electronic Instructions for Use
Instructions for Use for your scanner are provided in electronic form. They are stored on your scanner
and also available through the eIFU website. If a paper version is required, the user may print these
instructions himself/herself or request a paper version from the manufacturer. For further information,
delivery time and contact details see eIFU website: https://ifu.dentalwings.com
1.1 Disclaimer
This device is designed for use by persons who have appropriate knowledge in dentistry and dental
laboratory technology.
The user of this device is solely responsible for determining whether or not this device is suitable for a
particular patient case and circumstances. The user is solely responsible for the correctness,
completeness and adequacy of all data entered into this device and the used software. The user must
check the correctness of the results and assess each individual case.
Dental Wings products must be used in accordance with their accompanying instructions for use.
Improper use or handling of Dental Wings products will void the warranty, if any, given for Dental Wings
products. If you require additional information on the proper use of Dental Wings products, contact your
local distributor. The user is not allowed to modify Dental Wings products.
4CHAPTER 1 | Intraoral Scanner Instructions for Use

DENTAL WINGS, ITS AFFILIATES OR DISTRIBUTORS DISCLAIM REPRESENTATIONS AND WARRANTIES
OF ANY KIND, WHETHER EXPRESSED OR IMPLIED, WRITTEN OR ORAL, WITH RESPECT TO THE
PRODUCTS, INCLUDING ANY WARRANTY OF MERCHANTABILITY, FITNESS FOR A PARTICULAR
PURPOSE, ERROR-FREE OPERATION OR NON-INFRINGEMENT, AND THE PRODUCTS ARE SOLD “AS IS”.
Our maximum liability arising out of the products or their use, whether based upon warranty, contract,
tort or otherwise, shall not exceed the actual payments received by us in respect of the purchase price
thereof. In no event shall we be liable for special, incidental or consequential damages, including, but
not limited to, loss of profits, loss of data or loss of use damages, arising hereunder or from the sale of
the products.
Updates to hardware and software components are made regularly. Therefore, some of the instructions,
specifications and pictures contained in these Instructions for Use may differ slightly from your
particular situation. Dental Wings reserves the right to revise or make changes or improvements to this
product or documentation at any time without obligation to notify any person of such revisions or
improvements.
Third party products and product data
When scanning and designing cases, the user may work with third party products and/or product data.
Dental Wings, its subsidiaries, or distribution partners disclaim any liability for damages in connection
with or arising from such third party product data or products being used within this scope.
1.2 License, trademarks and other rights
Software license
Your scanner software is protected by a license agreement and may be used or copied only in
accordance with the terms of this agreement. It is illegal to copy or use the software on any medium
except those permitted in the license agreement.
Availability
Some of the products and accessories mentioned in these Instructions for Use may not be available in
all countries.

Trade names and trademarks
DENTAL WINGS and/or other trademarks and registered trademarks from Dental Wings mentioned
herein are the trademarks or registered trademarks of Dental Wings. All other trademarks are the
property of their respective owners.
Copyright
Dental Wings documents may not be reprinted or published, in whole or in part, without the written
authorization of Dental Wings.
6CHAPTER 1 | Intraoral Scanner Instructions for Use

2. Introduction and overview
2.1 Intended use
The Intraoral Scanner is a dental 3D scanner intended to be used to digitally record topographical
characteristics of teeth and surrounding tissues. The system produces 3D scans for use in computer-
assisted design and manufacturing of dental restorations.
2.2 Device description and features
The Intraoral Scanner consists of a computer with embedded software, a monitor, and a handpiece
equipped with optical sensors.
Device variants and configuration
The Intraoral Scanner (Type: DW-IO) is delivered in two product variants (see Parts identification, p.18):
nModel 001 (cart)
nModel 100 (laptop)
The device is delivered in the following configurations:
nWith the distributor logo and color
nWith a distributor-specific set of accessories
nWith a distributor-specific software configuration
nWith a country-specific power cord
Note
The laptop (scanner unit of Model 100) can be replaced by the scanner unit of Model 010 (portable).

nMonitor with DisplayPort, DVI or HDMI ports and a minimum screen resolution of 1600 x 1080 pixels
nKeyboard (USB or PS/2)
nTwo-button mouse with scroll wheel (USB or PS/2)
nNetwork cable (RJ45)
nUninterruptible power supply to protect against power outages and voltage fluctuations. For the
operating voltage of your device see Technical data and label (p. 1).
The multi-die holder contains mounting putty to hold the dies. You may replace the delivered mounting
putty with an equivalent material which:
nis non-reflecting, non-staining, non-toxic, removable without trace
nhas sufficient plasticity in the operating temperature range
Novel features
The Intraoral Scanner does not contain novel features in relation to conventional dentistry. The software
supports digital realization of conventional dental services in the area of restorative prosthetic.
Principles of operation
Sensors in the handpiece of the Intraoral Scanner provide data, which is matched to each other in the
processing unit to create a digital impression.
Novel features
The Intraoral Scanner does not contain novel features in relation to conventional dentistry. It supports
digital realization of conventional dental services in the area of restorative prosthetic.
2.3 Accessories and products used in combination
The use of the Intraoral Scanner requires accessories (cleaning and disinfection products, standard
packaging material). Moreover, it can be used in combination with other products (e.g. CAD/CAM
software).
Dental Wings has validated the specific products given in chapter Technical data and label (see
Accessory parts, p.47), in Appendix A - Reprocessing of the handpiece sleeve (p. 51) and in Appendix B -
Reprocessing of the Intraoral Scanner (without handpiece sleeve) (p. 56). Others may be suitable as well
if they meet the requirements below. However, the user has to validate their compatibility with the
Intraoral Scanner.
8CHAPTER 2 | Intraoral Scanner Instructions for Use

The scanner is available in different configurations. For device variants and optional PC peripherals, see
chapter Device description and features (p. 7)For information on specific accessory sets, contact your
local distributor.Device description and features (p. 7)
Reprocessing
The Intraoral Scanner requires reprocessing. The particular use, specific requirements, as well as
validated products for the reprocessing material and equipment are found in Appendices A and B.
Cleaning and disinfection products : The scanner requires reprocessing with specific detergents and
disinfectants. They are specified in Appendices A and B.
The handpiece sleeve is a semicritical area and requires sterilization1. The handpiece body, the cable,
the scanner unit and the accessories are noncritical areas and require intermediate level disinfection.
Standard packaging material : Standard see-through sterilization pouch shall be used to protect the
handpiece after reprocessing. A size of 9 cm x 20 cm is required. In addition, a standard plastic bag may
be used to store the complete handpiece. A minimum size of 25 cm x 40 cm is required.
Further use of 3D scans
3D scans from the Intraoral Scanner may be used with other software products. It is required that such
products can handle open STL files. Dental Wings has validated the use of:
DWOS: 3D dental restorations design software
Straumann® CARES® Visual: 3D dental restorations design software
coDiagnostiX: Dental implant planning software
2.4 Indications
2.5 Precautions
The provided instructions contain important information on the safe and appropriate use of your scanner
and its software. Make sure to have read and understood this document prior to installing and operating
the device.
1The term sterilization is used in this manual to refer to the method used to reprocess semicritical areas, the term intermediate
level disinfection is used to refer to the method used to reprocess noncritical areas. Both are known as disinfection in certain
territories.

This scanner is capable of very precise scanning. To achieve scanning accuracy, comply with all the
given instructions.
The Intraoral Scanner (cart model) is a protection class I device. To avoid risk of electric shock it shall
only be connected to a power outlet with protective earthing.
The scanner is suitable for use in laboratories, dental offices and equivalent environment. However, the
protection against dust and water has not been specifically tested.
Install the scanner in accordance with the instructions. Before any maintenance action, unplug the
scanner from the power outlet.
The handpiece must be connected to the scanner unit prior to being used on patients. Make sure that
the handpiece/handpiece connector is plugged in the scanner unit before the handpiece comes into
contact with patients.
Keep the original packaging of the scanner for safe transportation in case of service, repair and
disposal. Unpack and pack your scanner following the instructions.
The Intraoral Scanner is only compatible with Dental Wings handpieces. Make sure you are connected
to the internet when plugging a handpiece for the first time.
Reprocessing shall be done before the first use, then after each use, as well as prior to service, repair
and disposal to prevent cross-contamination.
Always ensure a biunique relationship between patient, scan and treatment case.
Backup your data at regular intervals. It is the responsibility of the user to perform and maintain data
backups in order to prevent loss of data.
Protect your data against loss, unauthorized access and unauthorized use.
Model 001 (cart): Installing additional software may compromise system integrity, slow down
performance, and create compatibility issues.
Model 100 (laptop): Install only software validated to be used in combination with the scanner.
Always handle the handpiece with great care as it contains fragile components. Dropping the handpiece
and its sleeves on the floor may damage it permanently.
The handpiece heats up over normal body temperature, but it does not pose a hazard to patients due to
short term exposure and small contact area.
Always keep a 60 mm distance between eyes and the handpiece.
Make sure the scanner is placed in a safe and stable position.
10 CHAPTER 2 | Intraoral Scanner Instructions for Use

Never put any load on the scanner.
Make sure to comply with all applicable standards and technical regulations for any computer hardware
used. Computer hardware is not intended to be used in close proximity (within a distance of 1.5 meters)
to the patient. Do not use extension cords or multiple-socket extension cords to plug the hardware.
Do not dispose of this device as unsorted municipal waste. Collect separately.
2.6 Compatibility information
The device is compatible with the Intraoral Scanner software application version 3.0 and higher.
2.7 Data protection
Access to the software is restricted by the licensing system.
To protect data against loss or unauthorized use, several security mechanisms have been implemented:
nData encryption during storage and transfer through the internet
nAn archiving system to backup patient and planning data
nAn on-demand anonymization function for privacy protection
Data managed by the user may require a moderate or high level of protection to ensure privacy and avoid
misuse:
nHigh level: Data with additional statutory requirements in many countries (e.g. patient personal data
and medical information)
nModerate level: Data protected or restricted by contract or other agreement (e.g. license
information)
Bear in mind that the user is responsible for data protection on user side. Make sure to adequately
protect such data.

 Caution
 Protect your data against loss, unauthorized access and unauthorized use.
 - Secure your computer system by installing a malware scanner or firewall.
 - Use a strong password to protect your computer system, storage media and presentation devices.
 - Use data encryption to secure data on your computer system and storage media.
 - Backup your data regularly to avoid loss of data.
 - Use the anonymization function to protect patient personal data if required.
2.8 Further information
Dental Wings and its products are registered in the main markets. If you have any questions please
contact your local distributor.
Radiation information
The handpiece contains LEDs. They are rated Exempt according to applicable standards (see Technical
data and label, p.43).
 Caution
Always keep a 60 mm distance between eyes and the handpiece.
The Intraoral Scanner (cart model) contains a gesture recognition control, which includes an infrared
laser projector. It is rated Class1 according to applicable standards (see Technical data and label,
p.43).
Figure 1: SR300 assembly for gesture recognition module
12 CHAPTER 2 | Intraoral Scanner Instructions for Use

 Caution
 Usage, control, adjustment or execution of the infrared laser projector other than specified below
may result in hazardous exposure to radiation.
Usage of the gesture recognition module is specified in Gesture control - Model 001 (cart) (p. 26). The
gesture recognition module (SR300) contains an infrared laser projector and shall not be repaired,
modified or disassembled. In case of failure, contact your local distributor. Do not try to open any parts
of the SR300 assembly. The SR300 does not have any parts that shall be accessed, changed or adjusted
by the user. Modification or dissembling of SR300, especially the infrared laser projector, may result in
an emission over class I. The manufacturer of the Intraoral Scanner will notice the manufacturer of the
SR300 assembly or return the module before conducting any failure analysis.
Electromagnetic compatibility information
The Intraoral Scanner is suitable for use in professional home healthcare environment and does not
execute any essential performance function in the understanding of the applied product standards.
Nevertheless, it had been tested for electromagnetic compatibility (EMC) and needs special
precautions.
The Intraoral Scanner needs to be installed and put into service according to the Electromagnetic
Compatibility Guideline (see Appendix C - Electromagnetic Compatibility Guideline, p.60).

 Caution
 The use of accessories other than those specified in Technical data and label (see Accessory parts,
p.47) may result in increased emission or decreased immunity of the Intraoral Scanner.
 The Intraoral Scanner allows for wireless network connection. However, it may be interfered with
radio frequency (RF) sources in the vicinity of the device (e.g, electromagnetic security systems,
cellular telephones, radio frequency identification (RFID) or other in-band transmitters), even if that
other equipment complies with the International Special Committee on Radio Interference (CISPR)
emission requirements.
 Portable and mobile RF communications equipment may affect the performance of Intraoral
Scanner. Please avoid strong electromagnetic interference, e.g. nearby mobile phones, microwave
ovens during the use of the Intraoral Scanner.
 The Intraoral Scanner should not be used adjacent to or stacked with other equipment and that if
adjacent or stacked use is necessary, the Intraoral Scanner should be observed to verify normal
operation in the configuration in which it will be used.
 Other portable radio frequency 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
Intraoral Scanner, including cables specified by the manufacturer. Otherwise, degradation of the
performance of this device could result.
2.9 Disposal
 Caution
 Reprocess prior to disposal to prevent cross-contamination.
Electrical and electronic devices must be disposed of separately from normal household waste in order
to promote reuse, recycling and other forms of recovery, to avoid adverse effects on the environment
and human health as a result of the presence of hazardous substances in some of their components
and to reduce the quantity of waste to be eliminated with a view to reducing landfill. This includes
accessories such as remote controls, power cords, etc.
 Caution
 Do not dispose of this device as unsorted municipal waste. Collect separately.
14 CHAPTER 2 | Intraoral Scanner Instructions for Use

For details on how to dispose of your device and its packaging, please contact your local distributor.

3. Installation
 Caution
 Keep the original box and packaging material for safe transportation of the device in case of service,
repair and disposal. Unpack and pack your scanner following the instructions.
For instructions on how to pack the scanner, see Packing the scanner (p. 40).
3.1 Unpacking the scanner
Store the shipping box in a safe place in case you need to transport or ship the scanner in the future.
Model 001 (cart)
1 2 3 4
5 6  
Figure 2: Steps for unpacking the scanner — Model 001
16 CHAPTER 3 | Intraoral Scanner Instructions for Use

Model 100 (laptop)
12345

Figure 3: Steps for unpacking the scanner — Model 100
3.2 Setting up the scanner
 Caution
Make sure you have read and understood these instructions for use before installing and operating the scanner.
Comply with all precautions and safety information.
 Install the scanner in accordance with the manufacturer's instructions.
 The scanner is suitable for use in laboratories, dental offices and equivalent environment. However,
the protection against dust and water has not been specifically tested. See Technical data and label,
p.43.
 Do not install the scanner in places with high temperature differences, near heat sources, in direct
sunlight or in damp environment (e.g. exposed to splash water). Do not expose this device to rain or
moisture. Do not install the scanner in dusty environment.
 Do not block any ventilation openings.
 Turn off the scanner before plugging or unplugging the power cable.
 Always handle the handpiece with great care as it contains fragile components. Dropping the
handpiece and its sleeves on the floor may damage it permanently.
The handpiece must be connected to the scanner unit prior to being used on patients.

Parts identification
Figure 4: Identification of the scanner parts
1. Scanner
2. Screen
3. Handpiece
a. optics
b. sleeve
c. light ring
4. Cable hook
5. Handle
6. Wheel lock
7. Integrity-check sleeve
8. Power switch
9. Power button
10. Gesture/voice recognition
module
11. Power cord/power supply
12. Holder
13. Handpiece connector
power supply
14. USB cable
15. Handpiece connector
(with holder)
Note
The laptop (scanner unit of Model 100) can be replaced by the scanner unit of Model 010 (portable).
18 CHAPTER 3 | Intraoral Scanner Instructions for Use

Connecting the handpiece
nPlug the handpiece cable into the socket at
the back of the screen.
nPlug the end of the handpiece cable into the
handpiece connector.
nPlug the handpiece connector via USB into the
socket on the laptop.

Figure 5: Plugging the handpiece to the back of the screen — Model
001 (cart)
Figure 6: Plugging the handpiece to the handpiece connector — Model
100 (laptop)
 Caution
Make sure that the handpiece/handpiece connector is plugged in the scanner unit before the
handpiece comes into contact with patients.
Disconnecting the handpiece
If the scanner unit is shut down, disconnect the handpiece by unplugging the USB from the socket.
If the scanner unit is still on, disconnect handpiece as follows:
1. Select the Settings icon of the taskbar, then the Handpiece Management submenu.
2. Select the Disconnect button.
3. To release the cord, unplug the USB from the socket.