Dental Wings 100 User manual

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

CONTENTS
1. About this guide 3
1.1 Disclaimer 3
1.2 License, trademarks and other rights 4
2. Introduction and overview 6
2.1 Intended use 6
2.2 Device description and features 6
2.3 Accessories and products used in combination 7
2.4 Indications 8
2.5 Precautions 8
2.6 Compatibility information 10
2.7 Data protection 11
2.8 Further information 12
2.9 Disposal 15
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 34
6.3 Data backup 36
6.4 Software updates 36
6.4 Maintenance tools 37
6.5 Changing fine fuses 40
6.6 Service 41
7. Troubleshooting 42
8. Packing the scanner 45
9. Distributors and service 47
10. Technical data and label 48
11. Explanation of symbols 56
Appendix A - Reprocessing of the handpiece sleeve 58
Appendix B - Reprocessing of the Intraoral Scanner (without handpiece sleeve) 63
Appendix C - Electromagnetic Compatibility Guideline 68

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" refers to
the handpiece with its detachable sleeve component.
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.
3CHAPTER 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. The scanner software 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. The agreement is available through the main menu by
selecting the Configuration icon, then Agreement from the context menu (see Basic principles and user
interface, p.23) .
Availability
Some of the products and accessories mentioned in these Instructions for Use may not be available in all
countries.
CHAPTER 1 | Intraoral Scanner Instructions for Use 4

Third-party software
Your scanner software contains code from third-parties which is provided under specific licenses. License
conditions are available within the software through the main menu by selecting the Configuration icon, then
About from the context menu (see Basic principles and user interface, p.23) .
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.
5CHAPTER 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.
Variants
The Intraoral Scanner (Type: DW-IO) is delivered in two product variants (see Instructions for Use , p.1):
nModel 001 (cart) - Article No. 6000-1
nModel 100 (laptop) - Article No. 6300-1
The delivery contains all components necessary to run the Intraoral Scanner as intended. For details, see
Parts identification, p.18.
Notes
1. The laptop (scanner unit of Model 100) can be replaced by the scanner unit of Model 010 (portable).
2. Distributors may acquire laptops for Model 100, install the software, and validate the installation. For further details,
see Technical data and label, p.48.
 Caution
Laptops must comply with national safety regulations and be validated for use with the Intraoral
Scanner to ensure adequate performance. Refer to the information available for distributors.
CHAPTER 2 | Intraoral Scanner Instructions for Use 6

Configurations
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
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
Replacement parts, p.53) , in Appendix A - Reprocessing of the handpiece sleeve (p. 58) and in Appendix B -
Reprocessing of the Intraoral Scanner (without handpiece sleeve) (p. 63) . Others may be suitable as well if
they meet the requirements below. However, the user has to validate their compatibility with the Intraoral
Scanner.
The scanner is available in different configurations. For device variants and optional PC peripherals, see
chapter Device description and features (p. 6) . For information on specific accessories, contact your local
distributor.
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.
7CHAPTER 2 | Intraoral Scanner Instructions for Use

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 sterilization. The handpiece (without sleeve), the
cable, the scanner unit, and the accessories are noncritical areas and require intermediate or low level
disinfection.
Standard packaging material : Standard see-through sterilization pouches shall be used to prepare the
handpiece sleeve for sterilization or to protect the handpiece when stored on the Intraoral Scanner. A size of
9 cm x 20 cm is required. In addition, a standard plastic bag may be used to store the handpiece when
detached from the scanner. 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 surgery treatment planning software
2.4 Indications
The scanner is an intraoral optical 3D scanning device 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. The 3D scan is provided in a 3D geometry format.
The device allows several scanner heads embedded in the handpiece to scan at once from multiple angles.
It is intended to be used by dental professionals.
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.
The sleeve must be assembled to the handpiece before scanning. If it is not assembled correctly, the device
won't scan properly.
CHAPTER 2 | Intraoral Scanner Instructions for Use 8

Laptops must comply with national safety regulations and be validated for use with the Intraoral Scanner to
ensure adequate performance. Refer to the information available for distributors.
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 Intraoral Scanner (laptop model) is a protection class II device. Always use the power supply provided.
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. Only use the parts provided or specified. Before any
maintenance action, unplug the scanner from the power outlet.
The handpiece must always be connected to the scanner through the handpiece connector. Make sure the
handpiece is plugged as instructed before it comes into contact with patients.
Make sure the building and its electrical circuitry is grounded and the handpiece is never connected directly
to the laptop when using Intraoral Scanner (laptop model).
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 maintenance, service,
repair, and disposal to prevent cross-contamination.
Always ensure a biunique relationship between patient, scan and treatment case.
Protection of the data entered into the software is a shared responsibility. Please refer to the license
agreement for further details.
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.
The user is responsible to assure health data de-identification, data backup and disaster recovery, and health
data authenticity.
9CHAPTER 2 | Intraoral Scanner Instructions for Use

The user is responsible to configure the operating system of the Intraoral Scanner, and as applicable
integrate it in its network, as required by its IT Policy. This includes set up of automatic logoff, audit controls,
authorizations, configuration of security features, emergency access, malware detection/protection, node
authentication, personal authentication, physical locks, integration of the Intraoral Scanner in the product life
cycle roadmap, system and application hardening, health data storage confidentiality. In case logs for
auditing or emergency access related to services provided by Dental Wings are required, contact your local
distributor.
Certain functionalities and services require data transfer. Access to data, storage and transfer shall comply
to national regulations on information security. For further details on encryption methods, type of data
transferred, location of hosts, and storage refer to https://dentalwings.com/data-protection-faqs/.
Online updates are used to solve safety and/or information security issues. Such updates are mandatory.
Such will be clarified by the information provided with the online update.
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.
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.
CHAPTER 2 | Intraoral Scanner Instructions for Use 10

2.7 Data protection
 Caution
 Protection of the data entered into the software is a shared responsibility. Please refer to the license
agreement for further details. (see License, trademarks and other rights, p.4)
The user is responsible to configure the operating system of the Intraoral Scanner, and as applicable
integrate it in its network, as required by its IT Policy. This includes set up of automatic logoff, audit
controls, authorizations, configuration of security features, emergency access, malware
detection/protection, node authentication, personal authentication, physical locks, integration of the
Intraoral Scanner in the product life cycle roadmap, system and application hardening, health data
storage confidentiality. In case logs for auditing or emergency access related to services provided by
Dental Wings are required, contact your local distributor.
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
Bear in mind that the user is responsible for data protection on user side. Make sure to adequately protect
such data.
 Caution
The user is responsible to assure health data de-identification, data backup and disaster recovery, and
health data authenticity.
 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.
11 CHAPTER 2 | Intraoral Scanner Instructions for Use

 Caution
 Certain functionalities and services require data transfer. Access to data, storage and transfer shall
comply to national regulations on information security. For further details on encryption methods, type of
data transferred, location of hosts, and storage refer to https://dentalwings.com/data-protection-
faqs/.Protect your data against loss, unauthorized access and unauthorized use.

2.8 Further information
Dental Wings and its products are registered in the main markets. Please be aware that any serious incident
that has occurred in relation to the Intraoral Scanner should be reported to your local distributor and the
competent authority responsible for medical devices or data protection in your country. 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.48) .
 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.48) .
Figure 1: SR300 assembly for gesture recognition module
CHAPTER 2 | Intraoral Scanner Instructions for Use 12

 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.68) .
13 CHAPTER 2 | Intraoral Scanner Instructions for Use

 Caution
 The use of accessories other than those specified in Technical data and label (see Replacement parts,
p.53) 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.
CHAPTER 2 | Intraoral Scanner Instructions for Use 14

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.
For details on how to dispose of your device and its packaging, please contact your local distributor.
15 CHAPTER 2 | Intraoral Scanner Instructions for Use

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. 45) .
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
CHAPTER 3 | Intraoral Scanner Instructions for Use 16

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. Only use the parts provided or
specified.
 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.48.
 Make sure the building and its electrical circuitry is grounded and the handpiece is never connected
directly to the laptop when using Intraoral Scanner (laptop model).
 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.

17 CHAPTER 3 | Intraoral Scanner Instructions for Use

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
16. SharpAdjust
Note
The laptop (scanner unit of Model 100) can be replaced by the scanner unit of Model 010 (portable).
CHAPTER 3 | Intraoral Scanner Instructions for Use 18

Connecting the handpiece
nPlug the handpiece cable into the handpiece
connector at the back of the screen.
nPlug the handpiece cable into the handpiece
connector.
nPlug the handpiece connector via USB into the
socket on the laptop.

Figure 5: Plugging the handpiece — Model 001 (cart) Figure 6: Plugging the handpiece — Model 100 (laptop)
 Caution
The handpiece must always be connected to the scanner through the handpiece connector.
Make sure the handpiece is plugged as instructed before it comes into contact with patients.
Note
Perform the integrity check to validate installation or when the handpiece is dropped or subject to a shock, to confirm
that it still works as specified.
Disconnecting the handpiece
If the scanner unit is shut down, disconnect the handpiece by unplugging the USB from the socket.
19 CHAPTER 3 | Intraoral Scanner Instructions for Use