dental wings 100 Intraoral Scanner Instructions

: June 15, 2024
: dental wings

dental wings 100 Intraoral Scanner

dental-wings-100-Intraoral-Scanner

Product Information: Intraoral Scanner

Specifications:

Model: Original, Model 100, Model 001
Manufacturer: Dental Wings

About this guide

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.

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 theiraccompanying 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.

Introduction and overview

Intended use
The Intraoral Scanner is designed for use in dentistry and dental laboratory technology. It is intended to capture digital scans of the intraoral cavity for diagnostic and treatment planning purposes.

Device description and features
The Intraoral Scanner consists of a scanner unit, which is used to process scans, and a handpiece with a detachable sleeve component. The scanner unit and handpiece work together to capture accurate and detailed digital scans of the intraoral cavity.

Accessories and products used in combination
The Intraoral Scanner may be used in combination with various accessories and products for enhanced functionality. Please refer to the accompanying instructions for use of these accessories and products for proper usage guidelines.

Indications
The Intraoral Scanner is indicated for use in dental practices and laboratories to capture digital scans of the intraoral cavity. It can be used for various applications including but not limited to:

Dental impressions
Orthodontic treatment planning
Prosthetic restorations
Implant planning

Precautions
To ensure safe and effective use of the Intraoral Scanner, please observe the following precautions:

Only use the scanner as instructed in this user manual.
Do not expose the scanner to excessive heat or moisture.
Do not disassemble or modify the scanner.
Keep the scanner clean and free from debris.
Follow proper infection control protocols when using the
scanner.

Compatibility information

The Intraoral Scanner is compatible with various software platforms and systems. Please refer to the software documentation for compatibility information and system requirements.

Data protection

The Intraoral Scanner is designed to protect patient data and comply with data protection regulations. It is recommended to follow best practices for data security and privacy when using the scanner.

Further information

For further information on the Intraoral Scanner, including troubleshooting, maintenance, and technical support, please refer to the respective sections in this user manual or contact your local distributor.

Disposal

At the end of its life cycle, the Intraoral Scanner should be disposed of in accordance with local regulations and environmental guidelines. Contact your local authorities for proper disposal methods.

Installation

Unpacking the scanner
When unpacking the scanner, ensure that all components are present and undamaged. Refer to the packaging checklist for a list of included items. If any items are missing or damaged, contact your local distributor for assistance.

Setting up the scanner
Follow these steps to set up the Intraoral Scanner:

Place the scanner unit on a stable and level surface.
Connect the handpiece to the scanner unit.
Ensure that all cables are properly connected.
Power on the scanner and follow the on-screen instructions for initial setup.
Calibrate the scanner as per the calibration instructions provided.
Perform a test scan to ensure proper functionality.

Basic principles and user interface

The Intraoral Scanner operates based on the principles of optical scanning technology. It captures digital scans of the intraoral cavity by projecting light patterns and capturing the reflected light using a camera sensor.

The user interface of the Intraoral Scanner is designed to be intuitive and user-friendly. It allows for easy navigation and control of scanning parameters and settings.

Scanning

Accuracy
The Intraoral Scanner is designed to provide accurate and detailed digital scans of the intraoral cavity. However, it is important to follow proper scanning techniques and guidelines to ensure optimal accuracy.

Step-by-step
Follow these steps to perform a scan using the Intraoral Scanner:

Prepare the intraoral cavity by removing any debris or excess moisture.
Position the scanner tip in the desired area of the intraoral cavity.
Activate the scanning mode on the scanner unit or via the user interface.
Slowly move the scanner tip around the area of interest, ensuring complete coverage.
Monitor the scanning progress on the user interface.
Review the captured scan for accuracy and completeness.
Save or export the scan data as required.

Maintenance

Handling
When handling the Intraoral Scanner, please observe the following guidelines:

Handle the scanner with clean hands and avoid touching the optical components.
Avoid dropping or subjecting the scanner to excessive force.
Store the scanner in a clean and dry environment when not in use.

Reprocessing
The handpiece sleeve and scanner components may require reprocessing between uses. Follow the instructions provided in Appendix A for reprocessing the handpiece sleeve and Appendix B for reprocessing the Intraoral Scanner without the handpiece sleeve.

Data backup
It is recommended to regularly backup the scan data stored on the Intraoral Scanner to prevent data loss. Follow the instructions provided in the user manual or software documentation for data backup procedures.

Software updates
To ensure optimal performance and compatibility, it is important to keep the Intraoral Scanner software up to date. Check for software updates regularly and follow the instructions provided by the manufacturer for software update procedures.

Maintenance tools
The Intraoral Scanner may come with specific maintenance tools for cleaning and maintenance purposes. Refer to the user manual or accompanying documentation for information on the proper use of these tools.

Service

In case of any issues or malfunctions with the Intraoral Scanner, contact your local distributor or authorized service center for assistance. Do not attempt to repair or modify the scanner yourself, as it may void the warranty and compromise its performance.

Troubleshooting

The user manual provides a troubleshooting guide for common issues and errors encountered with the Intraoral Scanner. Refer to the troubleshooting section for step-by-step instructions on resolving these issues. If the problem persists, contact your local distributor or authorized service center for further assistance.

Packing the scanner

When packing the Intraoral Scanner for storage or transportation, follow these guidelines:

Disconnect all cables and accessories from the scanner unit.
Clean the scanner and remove any debris or contaminants.
Place the scanner unit and accessories in the original packaging or a suitable protective case.
Ensure that the scanner is securely packed to prevent damage during transportation.

Distributors and service

For information on authorized distributors and service centers for the Intraoral Scanner, refer to the user manual or contact the manufacturer directly. Authorized distributors and service centers can provide assistance with product inquiries, technical support, and servicing.

Technical data and labels

The user manual provides detailed technical information and specifications for the Intraoral Scanner. Refer to the technical data section for information on electrical requirements, dimensions, weight, and other technical specifications.

Intraoral Scanner
Instructions for Use
Original

Model 100

Model 001

dental wings

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.

CHAPTER 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

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.

CHAPTER 1 | Intraoral Scanner Instructions for Use

Introduction and overview

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 computerassisted design and manufacturing of dental restorations.

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): n Model 001 (cart) – Article No. 6000-1 n Model 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 labels, 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.

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Configurations
The device is delivered in the following configurations:
n With the distributor logo and color n With a distributor-specific set of accessories n With a distributor-specific software configuration n With 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. 54), in Appendix A – Reprocessing of the handpiece sleeve (p. 60) and in Appendix B Reprocessing of the Intraoral Scanner (without handpiece sleeve) (p. 65). 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.

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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

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.
Back up 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.

CHAPTER 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

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:
n Data encryption during storage and transfer through the internet n An archiving system to backup patient and planning data n An 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.

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- protectionfaqs/ . 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 labels, 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 labels, p. 48).

Figure 1: SR300 assembly for gesture recognition module

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 disassembling of the SR300, especially the infrared laser projector, may result in an emission over class I. The manufacturer of the Intraoral Scanner will notify 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 environments and does not execute any essential performance function in the understanding of the applied product standards. Nevertheless, it has 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 Guidelines (see Appendix C – Electromagnetic Compatibility Guidelines, p. 70).

CHAPTER 2 | Intraoral Scanner Instructions for Use

Caution
The use of accessories other than those specified in Technical data and labels (see Replacement parts, p. 54) may result in increased emissions 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 the 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 the Intraoral Scanner. Please avoid strong electromagnetic interference, e.g. nearby mobile phones, microwave ovens during 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

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.

CHAPTER 2 | Intraoral Scanner Instructions for Use

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)

Figure 2: Steps for unpacking the scanner — Model 001

CHAPTER 3 | Intraoral Scanner Instructions for Use

Model 100 (laptop)

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 labels, 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.

CHAPTER 3 | Intraoral Scanner Instructions for Use

Parts identification

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

Figure 4: Identification of the scanner parts
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

Connecting the handpiece
n Plug the handpiece cable into the handpiece connector at the back of the screen.

n Plug the handpiece cable into the handpiece connector.
n Plug 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.

CHAPTER 3 | Intraoral Scanner Instructions for Use

If the scanner unit is still on, disconnect handpiece as follows:
1. Select the Configuration icon of the main menu, then the Handpiece Management context menu. 2. Select Disconnect. 3. To release the cord, unplug the USB from the socket.

Assembling the handpiece sleeve
Slide the sleeve on the handpiece (without sleeve) and rotate clockwise to lock into position.

Disassembling the handpiece sleeve
Rotate the sleeve counterclockwise to unlock and slide it off the handpiece.

Figure 7: Assembling and disassembling the handpiece sleeve

Caution The sleeve must be assembled to the handpiece before scanning. If it is not assembled correctly, the device won’t scan properly.
Never leave the handpiece elsewhere than in its dedicated handpiece holder.

CHAPTER 3 | Intraoral Scanner Instructions for Use

Plugging the scanner unit
Caution 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.
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.
Protect the power cord from being walked on and from pinching.
Model 001 (cart) 1. Plug the power cord into the back of the scanner. 2. Plug the power cord into the power outlet. 3. Flip the power switch in the power on position (see Scanner controls, p. 23) 4. Press the power button (see Scanner controls, p. 23) Model 100 (laptop) 1. Plug the power cord in the back of the laptop. 2. Plug the power cord into the power outlet. 3. Press the power button (see Scanner controls, p. 23) Refer to instructions for using the device (see Basic principles and user interface, p. 23).

CHAPTER 3 | Intraoral Scanner Instructions for Use

Unplugging the scanner unit
Before any maintenance on the scanner, it should be unplugged as follows:
Model 001 (cart) 1. Turn off the device (see Shutting down the scanner, p. 25). 2. Flip the power switch in the power off position. 3. Unplug the power cord from the power outlet. 4. Loop the cord around the hook(s). Model 100 (laptop) 1. Turn off the device (see Shutting down the scanner, p. 25). 2. Unplug the power cord from the power outlet.
System language
The system language is preset. If this is not the case, contact your local distributor.

CHAPTER 3 | Intraoral Scanner Instructions for Use

4. Basic principles and user interface

Scanner controls
Power switch: used to power on the scanner unit

Model 001 (cart) Power button: used to start up the scanner unit

Model 001 (cart)

Model 100 (laptop)

Position (down) I O

Scanner status Power on Power off

Status Light on Light off

Scanner status Turned on Turned off

Light ring: provides the user with a feedback of handpiece’s status
Color Blinking, white to blue
Blue Green Red

Handpiece status
Preheating Preheated Scanning & acquiring data Scanning & not acquiring data

CHAPTER 4 | Intraoral Scanner Instructions for Use

Turning on the scanner
Caution Turn on the device only with the handpiece fully assembled (with handpiece sleeve).
Model 001 (cart) 1. Press the power switch in the power on position. 2. Press the power button. 3. Select your user icon and type in your PIN. Model 100 (laptop) 1. Press the power button. 2. Select your user icon and type in your PIN.
First use
When the scanner is activated for the first time, a wizard pops up to assist the user with the basic settings: create administrator account, create users, set credentials to local network and other scanner settings.
User interface
The user interface is mainly icon-driven and provides direct instructions for performing the scans. Here are the main items that you can access from the main menu that is displayed on the left side of the screen. Each menu has its own context menu to access its specific functionalities.

Change user or shutdown Workspace

Indicates the current workflow status of a case: Plan, Scan, Align, Review or Export.

Case database Dentist and patient database Configuration

CHAPTER 4 | Intraoral Scanner Instructions for Use

Data Transfer (Wi-Fi)
The Intraoral Scanner can be used offline, as a standalone device. It can also be connected to a wireless network to transfer, share, or back up data.
Caution Use protected Wi-Fi setup and access. Keep a distance to other communication devices of 13 cm when you are using 2.4 GHz and 19 cm when you are using 5 GHz.
Model 001 (cart)
1. Starting outside of the screen, swipe your finger from the left side to the center of the screen. 2. You now have access to the menu of the operating system. 3. Follow operating system instructions to connect to wireless networks.
Model 100 (laptop) Follow operating system instructions to connect to wireless networks.
Shutting down the scanner
Caution Wait until the scanner is completely shut down before unplugging the power cord.
Model 001 (cart) 1. Click the top icon in the main menu. 2. Select Shutdown. 3. Confirm (a warning pops up if a case is uploading to DWOS Connect). 4. Flip the power switch in the power off position if the power cord needs to be unplugged.
Model 100 (laptop) Follow shutdown instructions for your operating system.

CHAPTER 4 | Intraoral Scanner Instructions for Use

Gesture control – Model 001 (cart)
The cart model is equipped with a gesture recognition module. It works with an infrared laser sensor (for safety information, refer to Further information (p. 12)) which is located above the screen as shown in Figure 4: Identification of the scanner parts (p. 18). Using gesture control instead of the touch-screen prevents cross-contamination during scanning.

Step Hand gesture

Triggered action

Place hand wide open in front of the sensor.

Activates the gesture control feature.

Point one finger upwards.

Displays context menu.

Move hand wide open from side to side.

Point one finger upwards.

Move hand towards the sensor while the 5
finger is still pointing upwards.

6 Move hand wide open in any direction.

To navigate inside the context menu. Stops the navigation. You can therefore move your hand without affecting the selection. Enters the selection.
Moves the scan in 3D as if it was linked to your hand.

Voice control – Model 001 (cart)
The cart model is equipped with a voice recognition module. It works with a microphone which is located as shown in Figure 4: Identification of the scanner parts (p. 18). Using voice control instead of the touchscreen prevents cross-contamination, and lets you scan without moving your hands away from the patient or handpiece. The commands are listed below with their associated action.

Voice command io start

Triggered action Launches the scan for the current element (upper, lower or occlusion).

CHAPTER 4 | Intraoral Scanner Instructions for Use

io pause io next io reset io undo io redo io lock io unlock io screenshot io take photo io detect

Pauses the current scan (re-launch with the start command). Switches to the next step. Erases current data. Removes surface data in a chronological fashion. Restores surface data in a chronological fashion. Protects the current scan against modification. The locked surfaces turn into a reddish color. Releases the locked surfaces so that they can again be modified. They turn back into their original color. Takes a screenshot of the current view and attaches it to the order. Within the Add Picture feature of the Plan Editor: takes a photo from the screen built-in camera or from the handpiece camera, according to which one is active. Detects the scanbody when the handpiece is pointing at it during scanning.

CHAPTER 4 | Intraoral Scanner Instructions for Use

5. Scanning
5.1 Accuracy
This scanner performs highly accurate scans. For scanning accuracy as measured according to ISO 20896-1 and Dental Wings testing standard, see Integrity check (p. 37).
Caution To achieve scanning accuracy, comply with all given instructions.
Considering that the final accuracy and fit of the restoration highly depend upon the preciseness of the user’s manipulations and judgment, the clinical outcome is easily influenced by the following factors 1 :
n Scanning too fast n Jaws shifting during occlusion scan n Inadequate occlusion alignment
5.2 Step-by-step
Setup
Caution Make sure the scanner has been reprocessed as described in Reprocessing (p. 34).

1 Certain error sources can contribute with deviations in mm range.

CHAPTER 5 | Intraoral Scanner Instructions for Use

n Select a User or a Dentist. n Enter security PIN. n Select New case. n Enter case description, including tooth number, restoration type, material and shade. n Set Appointment Date for the preparation. n Set Due Date, as the target delivery for the restoration at your clinic. n Specify if a Pre- Preparation Scan is desired. n Select Patient (create or search). n Add notes and attach files as desired. n Select Next.
Preheat the handpiece prior to scanning. When the light ring turns red or green, the handpiece is ready for scanning.
Caution Always ensure a biunique relationship between patient, scan and treatment case.

Scan
Caution Scan the area of interest until sufficient data is collected. 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. See Temperature limits, p. 48.
n Prepare for scanning in the same way as necessary for taking a physical impression. The area to be scanned shall be dry (e.g. no bleeding, no saliva).
n Lift the handpiece from its holder. n Remove protective packaging from the handpiece, if any. n Scan (and re-scan as necessary) the area of interest. Scanning is most effective at 5 mm from
handpiece sleeve. Avoid contact to breached or otherwise compromised surfaces. n Scan upper and lower arches as well as bite, following on-screen instructions. n Select Next after each arch. n Replace the handpiece on its holder.
For further details regarding scanning techniques, visit our website.

CHAPTER 5 | Intraoral Scanner Instructions for Use

Alignment
Caution Verify that upper and lower arches are identified as such.
n Align upper and lower scans onto the bite scan, following on-screen instructions. n If needed, invert upper and lower arches by selecting Swap Arches. n If needed, switch quadrant by selecting Switch Sides. n Adequate superimposition can be observed when the surface presents an evenly marbled pattern
between both colors. Confirm by selecting Next.
Review
n Confirm complete occlusion by observing sufficient red areas. n Identify planned preparations on the scanning data. n Confirm adequate occlusal spacing on each preparation for restoration material using the gradient
slider. n Confirm absence of undercuts on each preparation by simulating the insertion axis. n If desired, specify part or complete margin line on each preparation.
Export to DWOS Connect
n In the Export screen, verify the case overview. n Select collaborating laboratory from the drop-down list. n Review or complete attachments and notes. n Select Export.
Back on the home screen, a progress bar is displayed until the case is sent. Wait until the progress is completed before turning off the device.

CHAPTER 5 | Intraoral Scanner Instructions for Use

Export to STL
n Click the Case database icon from the main menu. n On the case to export, swipe your fingers towards the right side of the screen. n Select Export STL. n Select the destination folder.

CHAPTER 5 | Intraoral Scanner Instructions for Use

6. Maintenance
6.1 Handling
Store handpiece, scanner unit, and SharpAdjust according to the specified ambient conditions (see Ambient conditions, p. 51). Use standard packaging material to protect the handpiece and accessories from contamination between uses (see Accessories and products used in combination, p. 7). Unplug the device during lightning storms or when unused for long periods of time. When not in use, SharpAdjust shall always have the sleeve cap on, and be kept in the original packaging.
Note
The product warranty does not apply if damage to the product is the result of a lightning strike.

CHAPTER 6 | Intraoral Scanner Instructions for Use

Caution Never put any load on the scanner. Make sure the scanner is placed in a safe and stable position. The surface the scanner is placed on shall be intended to carry the weight. Always lock the wheels when not moving the cart model. Push down the tabs for locking the wheels. Before any maintenance action, unplug and reprocess the scanner. To reduce the risk of electric shock, do not remove the cover. Refer servicing to qualified service personnel. Protect the handpiece from contamination between uses. Ensure that the packaging is large enough to contain the handpiece without excessively bending the cable. 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.
Moving the scanner to another room
Model 001 (cart) n Shut down according to instructions (see Shutting down the scanner, p. 25) n Flip the power switch to the Power off ( O ) position. n Unplug the cord from the power outlet and loop it around the hook(s). n Unlock the wheels by lifting up the red tab on each one of them. n Move the device while holding it by the handle (see Identification of the scanner parts, p. 18). n When arrived at destination lock each wheel by pushing down the tab.
Model 100 (laptop) n Shut down according to instructions (see Shutting down the scanner, p. 25) n Unplug the power cord from the outlet. You can now move the laptop to a new location.
Note If the handpiece is dropped or subjected to a shock, run the integrity check to confirm that it still works as specified. See Integrity check, p. 37.

CHAPTER 6 | Intraoral Scanner Instructions for Use

Transportation
Always use the original packaging to transport the scanner. Refer to instructions for Packing the scanner (p. 45) and Unpacking the scanner (p. 16).
6.2 Reprocessing
Reprocessing means the processing of re-usable medical devices. It includes as applicable:
n preparation at the point of use; n preparation, cleaning, disinfection; n drying; n inspection, maintenance and testing; n packaging; n sterilization; n storage.
Warning 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.
Caution Before any reprocessing, unplug the scanner and SharpAdjust from power outlet. 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.

CHAPTER 6 | Intraoral Scanner Instructions for Use

Make sure the optics are cleaned after disinfection as follows:
1. Disassemble the handpiece sleeve (see Assembling and disassembling the handpiece sleeve, p. 20).
2. Clean the optics on the handpiece sleeve and handpiece (without sleeve) (see Figure 8: Cleaning the optics of handpiece and sleeve, p. 35).
3. Wear gloves. Use a soft, lint-free, non-abrasive, absorbent, disposable cloth moistened with alcohol. Wipe the optics once in one direction. Repeat if needed.

Figure 8: Cleaning the optics of handpiece and sleeve

The Intraoral Scanner consists of semicritical and noncritical areas (see Figure 9: Disinfection levels of handpiece sleeve/scanner, p. 35). Semicritical are the areas contacting mucous membranes. Noncritical are the areas contacting skin, but not mucous membranes. The materials used in the semicritical areas are biocompatible. The semicritical area requires sterilization. The noncritical areas require intermediate or low level disinfection.

Noncritical areas: Intermediate or low level disinfection

Semicritical area: Sterilization

Intraoral Scanner (without handpiece sleeve)
Figure 9: Disinfection levels of handpiece sleeve/scanner

Handpiece sleeve

CHAPTER 6 | Intraoral Scanner Instructions for Use

Appendix A – Reprocessing of the handpiece sleeve and Appendix B – Reprocessing of the Intraoral Scanner (without handpiece sleeve) contain further details on how to reprocess..
The instructions given have been validated by Dental Wings as being capable of preparing the Intraoral Scanner for re-use (250 cycles). It remains the responsibility of the user to ensure that the reprocessing as actually performed using equipment, material and personnel in the dental or reprocessing facility achieves the desired result. This requires validation and routine monitoring of the process. Likewise, any deviation by the user from the instructions provided is performed under the sole responsibility of the user and should be properly evaluated for effectiveness and potential adverse consequences.
6.3 Data backup
Caution Back up 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 Intraoral Scanner performs automatic backups of the database, as long as you define a destination for it:
1. Log in as Administrator.
2. Select the Configuration icon from the main menu, then the System Settings context menu.
3. In the field Backup target directory, type in a location or click the Folder icon to browse to the desired destination for storing the files created by the automatic backup feature.
6.4 Software updates
The user is automatically notified about pending updates. Update the software as indicated to benefit from continuous improvements and to maintain regulatory compliance.
Caution 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.

CHAPTER 6 | Intraoral Scanner Instructions for Use

6.4 Maintenance tools
The Intraoral Scanner is a self-maintenance device. There are two maintenance tools available: n The integrity-check sleeve is a non-medical, non-electrical component delivered with all models of the Intraoral Scanner.
n SharpAdjust is a non-medical, electrical component of the Intraoral Scanner, with its own label. SharpAdjust is delivered to users upon request.
Users are prompted by the software to periodically apply the integrity-check sleeve to validate the integrity of the optics. If the integrity cannot be validated, users are guided to run SharpAdjust to fine-tune the optics.
Integrity check
The integrity-check sleeve is a maintenance tool used to validate the integrity of the optics of the scanner.
Caution Make sure the integrity-check sleeve is reprocessed as required before and after use. See Appendix B Reprocessing of the Intraoral Scanner (without handpiece sleeve), p. 65.

1. Make sure the handpiece (without sleeve) is connected to the scanner unit (see Disassembling the handpiece sleeve, p. 20).
2. Select the Configuration icon of the main menu, then Handpiece Management context menu.
3. Slide the integrity-check sleeve onto the handpiece and rotate clockwise to lock into position (see Figure 10: Using the integrity-check sleeve, p. 37) .
4. Select the Start test button and wait for confirmation and further instructions to display on the screen.
5. When the process is over, rotate the integrity-check sleeve counterclockwise to unlock and slide it off the handpiece.

Figure 10: Using the integrity-check sleeve

CHAPTER 6 | Intraoral Scanner Instructions for Use

Note
The scanner does not require calibration. However, the integrity check should also be performed if the handpiece sleeve is dropped or subject to a shock, to confirm that it still works as specified.
SharpAdjust
SharpAdjust is a maintenance tool used to fine-tune the optical system of the Intraoral Scanner. It is applied in case the integrity check is unsuccessful two times in a row.
Caution Make sure SharpAdjust is reprocessed as required before and after use. See Appendix B – Reprocessing of the Intraoral Scanner (without handpiece sleeve), p. 65. When SharpAdjust is not in use, store it with the sleeve cap on, in the original packaging.
Parts identification

1. Cap 2. SharpAdjust sleeve 3. SharpAdjust sleeve positions 4. Dial switch 5. Switch positions
Figure 11: Identification of SharpAdjust parts
Connecting SharpAdjust
SharpAdjust is connected and ready to use if the light is on. If SharpAdjust is not working properly, contact your local distributor.

CHAPTER 6 | Intraoral Scanner Instructions for Use

Model 001 (cart)

1. Plug the USB cable into SharpAdjust. 2. Plug the other end of the cable into a power
outlet using a USB power supply.
3. Remove the cap from the SharpAdjust sleeve.

Model 100 (laptop)

Figure 12: Plugging SharpAdjust for Model 001 (cart)

1. Plug the USB cable into SharpAdjust. 2. Plug the other end of the cable into the laptop USB
port. 3. Remove the cap from the SharpAdjust sleeve.
Figure 13: Plugging SharpAdjust for Model 100 (laptop)

CHAPTER 6 | Intraoral Scanner Instructions for Use

Running SharpAdjust
1. Connect SharpAdjust to a power outlet (see Connecting SharpAdjust, p. 38).
2. Make sure the handpiece (without sleeve) is connected to the scanner unit (see Disassembling the handpiece sleeve, p. 20).
3. Slide the handpiece into the SharpAdjust sleeve and rotate clockwise to lock into position.
4. Set SharpAdjust sleeve to position A and turn the dial switch to 1.
5. Launch SharpAdjust by selecting the Configuration icon from the main menu, then Handpiece Management from the context menu. Follow the on-screen instructions.
6. When the process is complete, rotate the handpiece counterclockwise to unlock and slide it out of the sleeve.
Figure 14: Using SharpAdjust to fine-tune the handpiece optics
Disconnecting SharpAdjust
1. Make sure that the handpiece is removed from SharpAdjust. 2. Unplug SharpAdjust. 3. Reprocess as described in Reprocessing (p. 34). 4. Put the cap back on the SharpAdjust sleeve and store the tool in its original packaging.
6.5 Changing fine fuses
Model 001 (cart) Model 001 (cart) of the Intraoral Scanner contains two fine fuses (see Technical data and labels, p. 48). They are located at the back of the scanner unit, inside the power switch assembly (see Figure 4: Identification of the scanner parts, p. 18). If necessary, exchange them in the following way:

CHAPTER 6 | Intraoral Scanner Instructions for Use

1. Using a small flathead screwdriver (approx. width 4 mm), lever out the insert. 2. Change the corresponding fine fuses. 3. Reassemble.

Figure 15: Instructions for changing fine fuses – Model 001 (cart)
6.6 Service
Caution Reprocess prior to service to prevent cross-contamination. To reduce the risk of electric shock, do not remove the cover. Refer servicing to authorized service personnel.
Do not replace components of the scanner without the prior authorization from your distributor. Refer servicing to authorized service personnel. Servicing is required when the device has been damaged in any way, has been exposed to rain or moisture, does not operate normally, or has been dropped. Contact your local distributor. The Intraoral Scanner does not require regular service. However, in certain countries it might be mandatory according to national law. A risked based approach taking into account the amount of usage is acceptable. It shall be conducted according IEC 62353. When returning your scanner for service or repair, pack the scanner as described in Packing the scanner (p. 45).

CHAPTER 6 | Intraoral Scanner Instructions for Use

7. Troubleshooting

Find below a list of messages (some are abbreviated) that could appear while using the Intraoral Scanner, and the actions that should be taken to solve the problem.

On-screen message

Required action

Start up and log in

Cannot start setup Credentials could not be verified.

Restart the device and try again.

It seems that there is no valid license to run Contact your local distributor to obtain a license.
this software on your system

The scanner initialization failed

Ensure that the handpiece is properly connected and restart the device.

Hardware and configuration

Integrity check unsuccessful SharpAdjust unsuccessful

Follow on-screen instructions or contact your local distributor.

Integrity check failed because of an unforeseen error…

An error has occurred.

Restart the device and try again.

No configuration file found for the connected handpiece.

The configuration file does not match the connected handpiece.

1. Check internet connection. 2. Click the Configuration icon in the main menu and select the Handpiece Management context menu. In the Overview section, click on the Download icon.

The connected handpiece has been qualified for demonstration only, not for clinical use.

The scan accuracy of the connected handpiece is not sufficient for patient cases.

CHAPTER 7 | Intraoral Scanner Instructions for Use

On-screen message Database Case creation failed. … could not be computed/imported… Unable to save… Patient/Dentist update/deletion failed. Database backup execution failed. Implant kit / ipflib file errors. Software Server errors. Error… loading 3D graphic resource. Unable to save the recorded message. Cannot recognize microphone. An error occurred while recording. Failed to convert case to XOrder… Dentist assignment failed. Wrong client version. Case export failed. Scanning Scanned area too small for meshing. Unable to create mesh from scanned points. Could not swap arches… … Failed to create a temporary directory… This case is not ready to export.

Required action
Restart the device and try again. Try to export in a different folder and/or a different file name. Select a valid implant kit file.
Restart the device and try again.
Run the updater again. Try to export in a different folder and/or a different file name. Scan more tooth surface before proceeding. Clear scan data and rescan. Clean up hard drive. Complete the scan workflow before exporting the case.

CHAPTER 7 | Intraoral Scanner Instructions for Use

On-screen message

Required action

No scan to save.

Complete the scan procedure and retry.

The scan has been interrupted to prevent overheating…

Wait one minute to let the handpiece cool down and then resume scanning.

DWOS Connect

No internet connection… Server not found/not reachable…

Check internet connection.

Authentication to DWOS Connect failed.

Try again later.

Failed to authenticate on DWOS Connect… Check DWOS Connect credentials.

Bad configuration for remote server.

Check that the DWOS Connect configurations are valid.

No remote server is configured.

Configure your case exchange server connection.

This case is not in queue.

Check if the case is in the upload queue in the workspace screen. If yes, restart the device and try again.

This case is already in queue.

Check if the case is in the upload queue in the workspace screen. If not, restart the device and try again.

Upload was canceled.

If you did not cancel the upload on purpose, restart the device and try again.

Please select a supplier…

Select a supplier in the export screen and export the case again.

Failed to upload case… Will automatically retry later.

Wait until it automatically retries. If it still fails, restart the device and try again.

Concurrent upload/multiple DWOS connect configurations not supported yet.
Internal server error (no token).

Contact your local distributor.

A case cannot be exported twice.

Delete the case in DWOS Connect web interface and try again.

DWOS Connect configuration mismatch… Use DWOS Connect web interface to delete the case.

If the recommended action does not solve the problem, or for other on-screen messages, contact your local distributor.

CHAPTER 7 | Intraoral Scanner Instructions for Use

8. Packing the scanner

Model 001 (cart)
Packing the scanner for transportation must be done as follows: n Shut down the scanner unit. n Flip the power switch in the power off position. n Unplug the power cord, wind it carefully and place it inside one of the packaging inserts. n Place the handpiece in its case. n Pack the scanner in its original box and packaging material as shown below.

Figure 16: Steps for packing the scanner – Model 001 (cart)

CHAPTER 8 | Intraoral Scanner Instructions for Use

Model 100 (laptop)

Figure 17: Steps for packing the scanner – Model 100 (laptop)

CHAPTER 8 | Intraoral Scanner Instructions for Use

9. Distributors and service
Refer servicing to authorized service personnel. In case of questions or repair, please contact your local distributor. Alternatively, contact support @dental-wings.com (in English, French or German).

CHAPTER 9 | Intraoral Scanner Instructions for Use

10. Technical data and labels

Technical data
Type/Model
Scanner unit input

Fuse WiFi Handpiece

Frequency Standards
Security
Effective Radiated Power Output
Temperature limits Weight Dimensions ( at tip x L) Type (acc. IEC 60601-1) Field of view Depth of field

DW-IO-001 (cart)
100 – 240 V ~, 50 Hz – 60 Hz, 540 VA

DW-IO-100 (laptop)
100 – 240 V~, 50 – 60 Hz, 72 VA Handpiece Connector input: 5 V , 15 W

5 mm x 20 mm, medium speed, 6 A, ceramic (high breaking capacity), 250 V ~ (2 x M6AH250V)

no fuse

2.4 GHz or 5 GHz

IEEE 802.11g/n/ac

Protected Access (WPA2) Protected Setup (PIN & PBC)

0.085 W for IEEE 802.11 n/ac (dual band) 5 GHz 0.353 W for IEEE 802.11 g/n (single band) 2.4 GHz

40°C – 48°C (104°F – 118°F)

approx. 130 g (approx. 0.29 lbs)

20 mm x 207 mm (0.8” x 8.1”)

Applied part type BF 19.9 mm x 25.5 mm 15 mm

CHAPTER 10 | Intraoral Scanner Instructions for Use

Technical data
Type/Model LED risk group (acc. IEC 62471) Laser class (acc. IEC 60825) Protection class (acc: IEC 60529)
Protection class (electrical)
Pollution Degree Mode of operation
Computer / operating system

DW-IO-001 (cart) Exempt1

DW-IO-100 (laptop)

Class 1

no laser

IPXO (noncritical area – no protection)

Class 1 Equipment; Basic insulation, relies on an earth for protection. The earth connection is achieved with a 3conductor mains cable ending in a 3-prong AC connector which shall be plugged into a corresponding AC outlet.

Class 2 Equipment: Double insulated electrical equipment which does not require a safety connection to earth for protection.

2; Normally only non-conductive pollution occurs. Temporary conductivity caused by condensation is to be expected.

Continuous

Integrated highperformance computer storage for 8000 cases Dedicated high-end graphic card Windows 10 operating system Integrated gesture and voice recognition modules

Minimum requirements2
Memory: 16 GB DDR4 at 2400 MHz Processor: Intel® CoreTM i78750H Graphic card: NVIDIA GeForce GTX 1060 with 6 GB GDDR5 Hard disk: 256 GB SSD Webcam

21” multi-touch screen

17” screen

1 Handpiece with handpiece sleeve measured in worst case scenario (60 mm distance). 2 Minimum requirements have been specified to allow for smooth operation of the software. The software might also run on configurations with higher performance. The suitability of such configurations has to be validated by the user.

CHAPTER 10 | Intraoral Scanner Instructions for Use

Technical data
Type/Model Dimensions uncrated (L x W x H)
Dimensions crated (L x W x H)
Weight uncrated Weight crated

DW-IO-001 (cart)
520 mm x 460 mm x 1270 mm (20.5″ x 18.1″ x 50.0″)

DW-IO-100 (laptop)
422 mm x 321 mm x 31 mm (16.6” x 12.6” x 1.2”)

600 mm x 510 mm x 1370 mm (23.6″ x 20.1″ x 53.9″)

613 mm x 409 mm x 216 mm (24.1″ x 16.1″ x 8.5″)

38.0 kg (84 lb)

5.9 kg (13.0 lbs)

54 kg (119 lb)

9.2 kg (20.2 lbs)

Technical data
Type/Model Input

SharpAdjust 5V , 150 mA

LED risk group (acc. IEC 62471) Exempt

Protection class (acc: IEC 60529)

IPXO (noncritical area – no protection)

Protection class (electrical)

Class 3 equipment, designed to be supplied from a separated extra-low voltage (SELV) power source. The voltage from a SELV supply is low enough that under normal conditions a person can safely come into contact with it without risk of electrical shock.

Pollution Degree

2; Normally only non-conductive pollution occurs. Temporary conductivity caused by condensation is to be expected.

Mode of operation

Continuous

Mandatory requirements:

Power source

SharpAdjust is powered via USB cable. A separate USB power supply containing the safety markings required by national regulation can be used, as well as a USB port on a laptop or personal computer.

CHAPTER 10 | Intraoral Scanner Instructions for Use

Technical data
Type/Model Dimensions uncrated (L x W x H)
Dimensions crated (L x W x H)
Weight uncrated Weight crated

SharpAdjust 112 mm x 94 mm x 169 mm (4.4″ x 3.7″ x 6.7″) 241 mm x 190 mm x 160 mm (9.5″ x 7.5″ x 6.3″) 800 g 1230 g

Ambient conditions Operating temperature Storage conditions Transportation temperature Relative humidity Atmospheric pressure

15ºC – 30ºC (59°F – 86°F) 10 ºC – 40ºC (50°F – 104°F), controlled moisture (no condensation) -40°C – 65°C (-40°F – 149°F) 20% – 80% 60 kPa – 106 kPa

Software applications Intraoral Scanner software application

Included x

Optional

Scanning parameters Patient characteristics Optical technology
Scanning accuracy/time Output format
51

No restrictions apply LED light High-speed measuring cameras Video cameras According to ISO 20896-1 and Dental Wings testing standard. For further details contact your local distributor (see Distributors and service, p. 47). Open STL or cloud sharing through DWOS Connect
CHAPTER 10 | Intraoral Scanner Instructions for Use

CHAPTER 10 | Intraoral Scanner Instructions for Use

Scanner labels
This is an example of the label on your device:
Figure 18: Device label — Model 001

Figure 19: Device label — Model 100 (bright background)

Figure 20: Device label — Model 100 (dark background)

CHAPTER 10 | Intraoral Scanner Instructions for Use

Replacement parts Model 001 Model 100

Part No.

Handpiece

6100-1

(Connection cable

length 2.54 m)

Handpiece Storage Case

70-0045

Handpiece Sleeve

6190-1

Handpiece Sleeve

Storage Case

Power Cord

Handpiece Connector Power Supply

70-0095

22-0156 (US, CN: Length 2.5 m) 22-0159 (EU) 22-0165 (UK) 22-0167 (BR)

21-0200

(US, EU, UK, AU)

Image

Intended use
Replacement or additional handpiece for the Intraoral Scanner.
Protects the handpiece and accessories during shipment and storage.
Replacement or additional handpiece sleeve for the Intraoral Scanner.
Protects handpiece sleeves during shipment and storage.
The countryspecific power cord connects the Intraoral Scanner to power outlet.
The countryspecific power supply connects the Intraoral Scanner to the power outlet.

CHAPTER 10 | Intraoral Scanner Instructions for Use

Replacement parts Model 001 Model 100

Part No.

Handpiece Connector Power Supply

21-0228 &

22-0303 (US, ZH)

22-0301 (EU, BR)

22-0300 (UK)

Integrity-check

Sleeve

6191-1

SharpAdjust

6195-1

SharpAdjust Storage Case

6195-2

Client Shipping

Crate

6092-1

Image

Intended use
The countryspecific power supply connects the Intraoral Scanner to the power outlet.
The integritycheck sleeve is a maintenance tool used to validate the integrity of the optics of the Intraoral Scanner.
The SharpAdjust is a maintenance tool used to finetune the optical system of the Intraoral Scanner.
Protects SharpAdjust during shipment and storage.
This box serves as (replacement) box for return shipment.

CHAPTER 10 | Intraoral Scanner Instructions for Use

Replacement parts Model 001 Model 100

Part No.

Client Shipping Box

6392-1

Image

Intended use
This box serves as (replacement) box for return shipment.

CHAPTER 10 | Intraoral Scanner Instructions for Use

11. Explanation of symbols

Indicates the device’s legal manufacturer
Indicates the date of manufacture and country of origin
Indicates the serial number of the device
Caution, consult Instructions for Use for important cautionary information.
Laser radiation
Class 1 laser product acc. to IEC 60825-1
Direct current
Alternating current Device fulfills the requirements of the European directives given on the EU Declaration of Conformity. Compliance with U.S. Occupational Safety and Health standards as well as SCC requirements (Canada) Device fulfills Medical Device Regulations (2002) and Radio Equipment Regulations (2017) and Restriction of the Use of Certain Hazardous Substances in Electrical and Electronic Equipment Regulations (2012) requirements Device complies with part 15 of the FCC rules.

CHAPTER 11 | Intraoral Scanner Instructions for Use

kg total weight with device

Environment friendly use period acc. to China RoHS Caution: US Federal law restricts this device to sale by or on the order of a licensed health-care practitioner. Contents of the transport package are fragile. Handle with care. Indicates the correct upright position of the transport package Do not dispose of this device as unsorted municipal waste. Collect separately.
Follow Instructions for Use Device includes a radio frequency transmitter; interference may occur in the vicinity of equipment marked with this symbol. Type BF Applied Part
Device weight is as indicated in the label, no working load permitted.
Temperature limit for transport
Humidity limitation
Atmospheric pressure limitation

CHAPTER 11 | Intraoral Scanner Instructions for Use

Model number
QR code indicates the Device Identifier (Labeler Identification Code given by Issuing Agency (D840), model no. of device (DWIO001) and unit of use in packaging. Human readable form indicates in addition the serial no. and the manufacturing date.
Please note that the above symbols may appear with inverted colors (e.g. on the nameplate).

CHAPTER 11 | Intraoral Scanner Instructions for Use

Appendix A – Reprocessing of the handpiece sleeve
Manufacturer: Dental Wings Inc. Method: Sterilization and intermediate or low level disinfection Device: Intraoral Scanner handpiece sleeve

Figure 21: Intraoral Scanner handpiece sleeve – semicritical surfaces
Precautions
n Always wear gloves. n Do not use abrasive cleaners. n Scratches on the optics cause damage to the handpiece sleeve. Be very careful in applying the soft, nylon-bristled brush
and specific cloth. n Protect personnel and surroundings from contamination while brushing. n Carefully avoid inserting any sharp instrument in the gaps surrounding the optics as this may create concentrate forces
on the glass susceptible to facture or delaminate the optics. n Do not use corrosive cleaning agents or disinfectants with acids, bases, oxidizing agents, and solvents (with exception
of alcohol). n Avoid circular movement when wiping optics. n Make sure the handpiece sleeve is completely dry before packing. n Regularly inspect and clean the equipment used. n When sterilizing multiple handpiece sleeves in one steam sterilizer cycle ensure that the sterilizer’s maximum load is not
exceeded.
Limitations on reprocessing
Repeated reprocessing has an effect on the handpiece sleeve. End of life is determined by cumulative effects of reprocessing, as well as damage and wear due to use. We strongly recommend that the user regularly inspects the handpiece sleeve. User are solely responsible for issues arising from the use of a damaged or worn handpiece sleeve.

Appendix A – Reprocessing of the handpiece sleeve

Equipment and material n Steam sterilizer (safety marking; qualified) n Enzymatic detergent intended for cleaning of medical devices made of metal, glass and plastics n Intermediate or low level disinfectant intended for surface disinfection of medical devices made of metal, glass and plastics; proven efficiency (e.g. FDA clearance, VAH/DGHM listing, CE marking) n Alcohol (suitable for cleaning optics) n Potable tap water (unless national regulation requires differently) n Soft, lint-free, non-abrasive, absorbent, disposable cloth n Soft, nylon-bristled brush n Syringe n Gloves (disposable, made of Nitrile or Latex) n Standard packaging material suitable for steam sterilization (temperature resistance up to at least 137°C (278.6°F), sufficient steam permeability)
Instructions
Point of use n Immediately remove excess soil within semicritical area using the cloth specified. n Reprocess within two hours maximum.
Preparation for decontamination
1. Disassemble handpiece sleeve from handpiece (see Instructions for Use, Disassembling the handpiece sleeve (p. 20)).
2. Transport handpiece sleeve to designated reprocessing area (there are no requirements on containment and transportation).
Cleaning: Automated
Automated cleaning has not been validated since users do not have the equipment to clean automatically. Therefore, automated cleaning must not be applied to the handpiece sleeve.

Appendix A – Reprocessing of the handpiece sleeve

Instructions
Cleaning: Manual
1. Select specific enzymatic detergent so that they comply with the equipment description of this procedure. Follow their instructions for use in terms of storage, concentration, application, temperature and post-rinsing.
2. Immerse handpiece sleeve in enzymatic detergent and soak as described in its instructions for use. 3. If residues are visible, thoroughly brush handpiece sleeve completely with the specified brush. 4. Use a syringe filled with detergent to flush all hard-to-reach areas of the handpiece sleeve. 5. Thoroughly rinse handpiece sleeve as described in the enzymatic detergent’s instructions for use. 6. Dry using a fresh cloth. Use a one-directional wipe for the optics.
Disinfection: Manual
1. Select intermediate or low level disinfectant so that they comply with the equipment description of this procedure. Follow their instruction for use in terms of storage, concentration, application, temperature and post-rinsing.
2. Immediately after disinfection, clean the optics with a one-directional wipe and alcohol using a fresh, moist cloth (see Instructions for Use,Reprocessing (p. 34)).
Drying
Rest handpiece sleeve (optics facing down) on a fresh cloth in a clean place at room temperature until it is completely dry.
Inspection and Testing n Visually inspect the handpiece sleeve thoroughly inside and outside for defects, damage and wear (e.g. for scratches, discoloration, corrosion, bubbles under the coating, coating deliminiation). n Check that there is neither clouding nor scratches or chip outs on the optics. n Replace handpiece sleeve in case of damage and wear.
Maintenance
Discard damaged instruments.

Appendix A – Reprocessing of the handpiece sleeve

Instructions
Packaging A standard sterilization packaging material shall be used. Ensure that the pack is large enough to contain the handpiece sleeve without stressing the seals. Sterilization 1. Select steam sterilizer so that they comply with the equipment description of this procedure. Follow their instruction
for use in terms of validation, loading weight, operating time and functional testing. 2. Select fractionated vacuum method (with sufficient device drying), with a minimum of 3 minutes at 132°C (270°F). 3. Do not exceed 134°C (273°F). 4. Drying time at least 30 minutes.
Storage Store the handpiece sleeve in its sterilization packing in a dry and dust-free location. Additional Information The Instructions for Use contain more detailed descriptions and figures on assembly/disassembly to handpiece, transportation, handling (including storage), disposal, technical data, ambient temperature etc. Manufacturer Contact See the Instructions for Use back cover.
The following material has been used to validate the reprocessing described above: · Enzymatic detergent: CIDEZYME®/Enzol® (ASP Johnson & Johnson), neodisher® MultiZym (Dr. Weigert) · Disinfectant (alcohol-based): Bacillol® 30 and Bacillol® 30 Sensitive (both Bode Chemie), Isopropanol 70% (Jedmon Products Ltd.), ProSprayTM and ProSpray C-60TM (both Certol® International) · Alcohol: Isopropanol 70% (Jedmon Products Ltd.) · Cloth: Clean Wipes (Sticklers), WFw – FiberWipesTM (AFL)

Appendix A – Reprocessing of the handpiece sleeve

Fundamental suitability of the handpiece sleeve (initial state and after repeated reprocessing) and the instructions provided above for effective reprocessing have been validated by an independent government accredited and recognized test laboratory using the equipment and material specified in the test report, CIDEZYME®/Enzol® (both ASP Johnson & Johnson) and ProSprayTM (Certol® International).
Non-detraction of functionality was demonstrated in repeated processing using the equipment and material specified in the test report, CIDEZYME®/Enzol® (both Johnson & Johnson) and ProSprayTM (Certol® International). In addition, it has been validated by Dental Wings using the aforementioned equipment and material, and neodisher® MultiZym (Dr. Weigert), Bacillol® 30 and Bacillol® 30 Sensitive (Bode Chemie), Isopropanol 70% (Jedmon Products Ltd.), ProSpray C-60TM (Certol® International).
The instructions given have been validated by Dental Wings as being capable of preparing the Intraoral Scanner handpiece sleeve for re-use (250 cycles). It remains the responsibility of the user to ensure that the reprocessing as actually performed using equipment, material and personnel in the dental or reprocessing facility achieves the desired result. This requires validation and routine monitoring of the process. Likewise, any deviation by the user from the instructions provided is performed under sole responsibility of the user and should be properly evaluated for effectiveness and potential adverse consequences.
Date issued: July 2022

Appendix A – Reprocessing of the handpiece sleeve

Appendix B – Reprocessing of the Intraoral Scanner (without
handpiece sleeve)
Manufacturer: Dental Wings Inc. Method: Intermediate or low-level disinfection Device: Intraoral Scanner (without handpiece sleeve), as per Instructions for Use, Setting up the scanner (p. 17)
Figure 22: Intraoral Scanner (without handpiece sleeve) – non-critical surfaces

Appendix B – Reprocessing of the Intraoral Scanner (without handpiece sleeve)

Precautions
n Always wear gloves. n Make sure the handpiece sleeve is disassembled from the handpiece and reprocessed separately as specified
(Appendix A – Reprocessing of the handpiece sleeve (p. 60)) n Do not autoclave. n Never immerse the handpiece in liquids. n Do not use abrasive cleaners. n Scratches on the optics cause damage to the handpiece. Be very careful when applying the specified cloth. n Do not use corrosive cleaning agents or disinfectants with acids, bases, oxidizing agents, and solvents (with the
exception of alcohol). n Avoid circular movement when wiping optics n Do not rinse the handpiece or the scanner unit. n Make sure the handpiece is completely dry before assembled to the handpiece sleeve. n Make sure the scanner unit is completely dry before being plugged into a power outlet.
Limitations on reprocessing
Repeated reprocessing has minimal effect on the Intraoral Scanner (without handpiece sleeve). End of life is normally determined by damage and wear due to use. We strongly recommend that the user regularly inspect the Intraoral Scanner (without handpiece sleeve). Users are solely responsible for issues arising from the use of damaged or worn Intraoral Scanner (without handpiece sleeve).
Equipment and material
n Intermediate or low level disinfectant intended for surface disinfection of medical devices made of metal, glass and plastics; proven efficiency (e.g. FDA clearance, VAH/DGHM listing, CE marking)
n Alcohol (suitable for cleaning optics) n Potable tap water (unless national regulation requires differently) n Soft, lint-free, non-abrasive, absorbent, disposable cloth n Gloves (disposable, made of Nitrile or Latex)

Appendix B – Reprocessing of the Intraoral Scanner (without handpiece sleeve)

Instructions
Point of use n Immediately remove excess soil using the cloth specified. n Reprocess within two hours maximum.
Preparation for decontamination 1. Unplug scanner (see Instructions for Use, Unplugging the scanner unit (p. 22)). 2. Disconnect the handpiece from the scanner (see Instructions for Use, Disconnecting the handpiece (p. 19)). 3. Select specific intermediate or low-level disinfectant according to its instructions for use. Follow it in terms of storage, concentration, application and temperature.
Cleaning: Automated Automated cleaning must not be applied for the Intraoral Scanner (without handpiece sleeve). Cleaning: Manual Clean all surfaces with the cloth specified, moistened with potable tap water. Use a one-directional wipe for the optics. Disinfection: Automated Automated disinfection must not be applied for Intraoral Scanner (without handpiece sleeve). Disinfection: 1. Apply intermediate or low-level disinfectant as described in the disinfectant’s instructions for use. Use the cloth
specified for wiping. 2. Immediately after disinfection, clean the optics with a one-directional wipe and alcohol using a fresh, moist cloth
(see Instructions for Use, Reprocessing (p. 34)).
Drying Dry at room temperature until completely dry.

Appendix B – Reprocessing of the Intraoral Scanner (without handpiece sleeve)

Instructions

Inspection and Testing n Visually inspect for damage and wear (e.g. for scratches, discoloration, corrosion). n Check that there is neither clouding nor scratches or chip-outs on the optics or the optics of the handpiece. n In case of doubt, conduct an integrity check (see Instructions for Use, Maintenance tools (p. 37). n Replace handpiece in case of damage and wear (e.g. deep scratches, corrosion, failed maintenance as per Instructions for Use, Maintenance tools (p. 37).
Maintenance Maintenance as per Instructions for Use, Maintenance (p. 32) Sterilization Sterilization must not be applied for the Intraoral Scanner (without handpiece sleeve). Sterilization is not required (all surfaces are classified noncritical). Packaging/Storage No requirements in particular. If the handpiece is stored on the scanner unit, cover it with an open see-through sterilization pouch. A size of 9 cm x 20 cm is required. A standard plastic bag may be used to store the complete handpiece when detached from the scanner. A minimum size of 25 cm x 40 cm is required. Additional Information Consult the Instructions for Use for more details. Manufacturer Contact See the Instructions for Use back cover.
The following material has been used to validate the reprocessing described above: n Disinfectant (alcohol-based): Bacillol® 30 and Bacillol® 30 Sensitive (both Bode Chemie), Isopropanol 70% (Jedmon Products Ltd.), ProSpray C-60TM (Certol® International) n Alcohol: Isopropanol 70% (Jedmon Products Ltd.) n Cloth: Clean Wipes (Sticklers), WFw – FiberWipesTM (AFL)

Appendix B – Reprocessing of the Intraoral Scanner (without handpiece sleeve)

Fundamental suitability of the Intraoral Scanner (without handpiece sleeve) (initial state and after repeated reprocessing) and the instructions provided above for effective reprocessing has been validated by Dental Wings. Non- detraction of functionality was demonstrated in repeated reprocessing using the equipment and material specified in the test reports, including Bacillol® 30 and Bacillol® 30 Sensitive (both Bode Chemie), Isopropanol 70% (Jedmon Products Ltd.), ProSpray C-60TM (Certol® International).
The instructions given have been validated by Dental Wings as being capable of preparing the Intraoral Scanner (without handpiece sleeve) for re-use (250 cycles). It remains the responsibility of the user to ensure that the reprocessing as actually performed using equipment, material and personnel in the dental or reprocessing facility achieves the desired result. This requires validation and routine monitoring of the process. Likewise, any deviation by the user from the instructions provided is performed under sole responsibility of the user and should be properly evaluated for effectiveness and potential adverse consequences.
Date issued: July 2022

Appendix B – Reprocessing of the Intraoral Scanner (without handpiece sleeve)

Appendix C – Electromagnetic Compatibility Guidelines

Guidance and manufacturer’s declaration – electromagnetic emissions

The Intraoral Scanner is intended for use in the electromagnetic environment specified below. The user of the Intraoral Scanner should assure that it is used in such an environment.

Emission test

Compliance

Electromagnetic environment guidance

RF emissions CISPR 11

Group 1

The Intraoral Scanner uses radio frequency (RF) energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.

RF emissions CISPR 11

Class B

Harmonic emissions IEC 61000-3-2

Class A

Voltage fluctuations/ flicker emissions Complies
IEC 61000-3-3

The Intraoral Scanner 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.

Table 1

Guidance and manufacturer’s declaration electromagnetic immunity

The Intraoral Scanner is intended for use in the electromagnetic environment specified below. The user of the Intraoral Scanner should assure that it is used in such an environment.

Immunity Test

IEC 60601 test level

Compliance level

Electromagnetic environment guidance

Electrostatic discharge (ESD)
IEC 61000-4-2

± 8 kV contact ± 2/4/8/15 kV air

Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.

Electrical fast transient/burst IEC 61000-4-4
Surge IEC 61000-4-5

± 2 kV 100 kHz repetition frequency
± 0.5/1 kV line to line ± 0.5/1/2 kV line to ground

Mains power quality should be that of a typical commercial or hospital environment.
Mains power quality should be that of a typical commercial or hospital environment.

Appendix C – Electromagnetic Compatibility Guidelines

Voltage dips and interruptions
IEC 61000-4-11

0% UT ; 0.5 cycle at 0°, 45°; 90°, 135°, 180°, 225°, 270°, and 315°
0% UT ; 1 cycle and 70% UT ; 25/30 cycles Single phase: at 0°
0% UT; 250/300 cycles

Rated power frequency magnetic field IEC 61000-4-8

30 A/m 60 Hz

0% UT ; 0.5 cycle at 0°, 45°; 90°, 135°, 180°, 225°, 270°, and 315° 0% UT ; 1 cycle and 70% UT ; 25/30 cycles Single phase: at 0° 0% UT; 250/300 cycles
30 A/m 60 Hz

NOTE UT is the a.c. mains voltage prior to application of the test level. Table 2

Mains power quality should be that of a typical commercial or hospital environment. If the user of the Intraoral Scanner requires continued operation during power shortages, it is recommended that the Intraoral Scanner be powered from an uninterruptible power supply or a battery.
Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.

Guidance and manufacturer’s declaration electromagnetic immunity

The Intraoral Scanner is intended for use in the electromagnetic environment specified below. The user of the Intraoral Scanner should assure that it is used in such an environment.

Immunity Test

IEC 60601 test level

Compliance level

Electromagnetic environment guidance

Portable and mobile RF communications equipment should be used no closer to any part of the Intraoral Scanner, including cables, than the recommended distance calculated from the equation applicable to the frequency of the transmitter.

Equation for distance calculation

Conducted disturbances inducted by RF fields IEC 61000-4-6

3V 0.15 MHz – 80 MHz 6 V in ISM bands between 0.15 MHz 80 MHz 80% AM at 1 kHz

3V 0.15 MHz – 80 MHz 6V in ISM bands between 0.15 MHz 80 MHz 80% AM at 1 kHz

d = 1.2 P

Appendix C – Electromagnetic Compatibility Guidelines

Radiated RF EM fields IEC 61000-4-3

3 V/m 80 MHz – 2.7 GHz 80% AM at 1 kHz

d = 1.2 P 80 MHz to 800 MHz
d = 2.3 P 800 MHz to 2.7 GHz

Immunity to proximity fields from RF wireless communications equipment IEC 61000-4-3 (IEC61000-439)

IEC 60601-1-2:2014; Table 9

d = 6/E P 380 MHz to 5.8 GHz

P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and E is
the Immunity Test Level (V/m), and d is the recommended separation distance in meters (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey,a should be less than the compliance level in each frequency range.b Interference may occur in the vicinity of equipment marked with the following symbol:

NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.
a) Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the Intraoral Scanner is used exceeds the applicable RF compliance level above, the Intraoral Scanner should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the Intraoral Scanner.
b) Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 10 V/m.
Table 3

Band (MHz)
380-390 TETRA 400

IEC 60601-1-2:2014, Table 9

Service

P
Max. power (W)

d
Distance (m)

1.8

0.3

E Immunity test level
(V/m)
27

Appendix C – Electromagnetic Compatibility Guidelines

430-470 GMRS 460; FRS 460

704-787 LTE Band 13, 17

0.2

GSM 800/900; TETRA 800; iDEN 820; CDMA 850; LTE

800-960

Band 5

24002570

Bluetooth; WLAN; 802.11 b/g/n; RFID 2450; LTE Band 7 2

5100-

WLAN 802.11 a/n

0.2

5800

Table 4

0.3

Appendix C – Electromagnetic Compatibility Guidelines

Recommended separation distances between portable and mobile RF communications equipment and the Intraoral Scanner

The Intraoral Scanner is intended to be used in an electromagnetic environment in which radiated RF disturbances are controlled. The user of the Intraoral Scanner can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Intraoral Scanner as recommended below, according to the maximum output power of the communications equipment.

Rated maximum output power of transmitter (W)

Separation distance according to frequency of transmitter (M)

150 kHz to 800 MHz d = 1.2 P

800 MHz to 2.7 GHz d = 2.3 P

380 MHz to 5.8 GHz d = 6/E P

0.01

0.12

0.23

N.A.

0.0851

N.A.

0.19

0.1

0.38

0.73

N.A.

0.3521

N.A.

0.13

1.2

2.3

N.A.

3.8

7.3

N.A.

100

N.A.

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. NOTE 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. 1) Maximum output power of the RF transmitter included in the Intraoral Scanner used in IEEE 802.11ac and 802.11n dual band (5 GHz). 2) Maximum output power of the RF transmitter included in the Intraoral Scanner used in IEEE 802.11g and 802.11n single band (2.4 GHz).
Table 5

Appendix C – Electromagnetic Compatibility Guidelines

www.dentalwings.com

Dental Wings Inc.
160 Rue St-Viateur E Montreal QC H2T 1A8 CANADA
T +1 514 807-8485 (International) T +1 888 856-6997 (North America) F +1 514 223-3981
Intraoral Scanner Instructions for Use_EN 29-0100 v 4.4

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References

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dental wings 100 Intraoral Scanner

Product Information: Intraoral Scanner

About this guide

Disclaimer

Introduction and overview

Compatibility information

Data protection

Further information

Disposal

Installation

Basic principles and user interface

Scanning

Maintenance

Service

Troubleshooting

Packing the scanner

Distributors and service

Technical data and labels

About this guide

Introduction and overview

Data protection

Radiation information

Installation

Parts identification

Instructions

References

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