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Intraoral Scanner User Manual - EN (v.1.5)
Intraoral Scanner User Manual - EN (v.1.5)
User Manual
Original User Manual
Model DW-IO-001
dental wings
CONTENTS
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 working with the device. In case of
questions, contact your local distributor.
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 provided software. The user has to check the correctness and
accuracy of the results and to 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.
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 the User Manual 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.
Availability
Some of the products and accessories mentioned in the User Manual may not be available in all countries.
All other trademarks and logos mentioned in this document are trademarks, registered trademarks or logos 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.
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. The software
supports digital realization of conventional dental services in the area of restorative prosthetic.
Since Dental Wings is continuously validating other suitable accessories and products, you may also contact your
local distributor for more information.
Scanning
Scanning with the Intraoral Scanner requires surface coating. Suitable coating shall be intended to be used for
intra- or extra-oral application in digital dentistry for matting surfaces and enhancing contrast on objects to be
scanned.
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.
Standard Laboratory Bottle : The bottles are used for soaking the handpiece. They shall be resistant to the
cleaning and disinfection agents and fit into the reprocessing station. They shall meet the following
characteristics:
n Height: 146 mm
n Diameter: 60 mm
n Inner diameter of bottle mouth: 45 mm
n Capacity: 250 ml
Cleaning and disinfection products : The scanner requires reprocessing with specific detergents and
disinfectants. They are specified in Appendices A and B.
Standard packaging material: Standard see-through sterilization pouch shall be used to protect the semicritical
area of the handpiece after reprocessing. A size of 9 cm x 20 cm is required. In addition, a standard plastic bag
may be used to store the complete handpiece. A minimum size of 25 cm x 40 cm is required.
2.5 Contraindications
The device is not intended to create images of the internal structure of teeth or the supporting skeletal structure.
It is not intended to be used for cases with more than four (4) subsequent edentulous tooth positions.
2.6 Precautions
This scanner is capable of very precise scanning. To achieve scanning accuracy, comply with all the given
instructions .
This device is a protection class I device. To avoid risk of electric shock it shall only be connected to a power
outlet with protective earth.
The scanner is suitable for use in laboratories, dental offices and equivalent environment. However, the
protection against dust and water has not been specifically tested.
Install the scanner in accordance with the instructions. Before any maintenance action, unplug the scanner from
the power outlet.
Keep the original packaging of the scanner for safe transportation in case of 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 and
disposal to prevent cross-contamination.
Always ensure a biunique relationship between patient, scan and treatment case.
Backup your data at regular intervals. It is the responsibility of the user to perform and maintain data backups in
order to prevent loss of data.
Always handle the handpiece with great care as it contains fragile components. Dropping the handpiece on the
floor may damage it permanently.
The handpiece heats up over normal body temperature, but it does not pose a hazard to the patient due to short
term exposure and small contact area.
Radiation information
The Intraoral Scanner contains a gesture control module, which includes an infrared laser projector. It is rated
class 1 according to applicable standards (see Technical data and label, p. 31).
The handpiece contains LEDs. They are rated exempt according to applicable standards (see Technical data and
label, p. 31).
The Intraoral Scanner needs to be installed and put into service according to the Electromagnetic Compatibility
Guideline (see Appendix C - Electromagnetic Compatibility Guideline, p. 47).
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.
Caution
Keep the original box and packaging material for safe transportation of the device in case of repair and
disposal. Unpack and pack your scanner following the instructions.
For instructions on how to pack the scanner, see Packing the scanner (p.29) .
1 2 3 4
5 6
Parts identification
1. Cart
2. Screen
3. Handpiece
a. optics
b. head
c. light ring
4. Reprocessing
station
5. Cable hook
6. Handle
7. Wheel lock
8. Integrity-check
tool
9. Power switch
1. Select the Settings icon of the taskbar, then the Handpiece Management submenu.
2. Select the Disconnect button.
3. To release the cord from the cart, press both sides of the mobile cylinder and pull it towards you.
4. Then the cord can be released from the socket.
Caution
This device is a protection class I device. To avoid risk of electric shock it shall only be connected to a power
outlet with protective earth.
To prevent fire or shock hazard, do not use the plug with an extension cord.
Protect the power cord from being walked on and from pinching.
Refer to instructions for using the device (see Basic principles and user interface, p. 15).
1. Turn off the device (see Shutting down the device, p. 16).
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 hooks.
Integrity check
Caution
Make sure the integrity-check tool is reprocessed as required before and after it's use (see Appendix B -
Reprocessing of cart and accessories, p. 44).
Note
This procedure should also be performed if the handpiece was dropped or subject to a shock, to confirm that it is
in good operating condition.
System language
The system language is preset. If this is not the case, contact your local distributor.
Scanner controls
I Power on
O Power off
Light on Turned on
Blue Preheated
User interface
The user interface is mainly icon-driven and provides direct instructions for performing the scans. Here are the
main stations that you can access from the taskbar that is displayed on the left side of the screen:
1 4
Change user or shutdown Case database
2 5
Workspace Dentist and patient database
3 6
Settings and Options
| | | |
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 Windows menu and taskbar.
3. Follow manufacturer's instructions for managing wireless connections on Microsoft Windows 10.
Caution
Use protected WiFi 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.
1 Place hand wide open in front of the sensor. Activates the gesture control feature.
3 Move hand wide open from side to side. To navigate inside the contextual menu.
Jarvis start Launches the scan for the current element (upper, lower or occlusion).
Jarvis pause Pauses the current scan (re-lauch with the start command).
5.1 Accuracy
This scanner is capable of very precise scanning. For scanning accuracy as measured according to Dental Wings
testing standard, see Technical data and label (p.31).
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 :
5.2 Step-by-step
Setup
Caution
The scanner must be turned off before plugging or unplugging any device or cable.
Make sure the scanner has been reprocessed as described in Reprocessing (p.23).
A short pre- heating must take place 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
The use of surface coating is required on the patient's teeth. Apply a uniform and very thin layer to ensure
teeth characteristics are not modified by the material. Always comply with the instructions given by the
surface coating manufacturer.
The handpiece will heat up over normal body temperature (see Temperature limits, p. 31), but it does not pose a
hazard to the patient due to short term exposure and small contact area.
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.
Back to the home screen, a progress bar is displayed until the case is sent. Wait until the progress is completed
before turning off the device.
Export to STL
n Click the Case database icon from the taskbar;
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.
6.1 Handling
Store the handpiece and cart according to the given ambient conditions (see Ambient conditions, p. 32).
Use standard packaging material to protect the handpiece from contamination between uses (see Accessories
and products used in combination, p. 6).
Unplug this device during lightning storms or when unused for long periods of time.
Note
The product warranty does not apply if damage to the product is the result of a lightning strike.
Caution
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.
Never leave the handpiece elsewhere than in its dedicated cradle.
Ensure that the packaging is large enough to contain the handpiece without excessively bending the cable.
Always lock the wheels when not moving the device. Push down the red tab for locking the wheels.
Do not install or uninstall software on the system.
Note
If the handpiece was dropped or subject to a shock, run the integrity check to confirm that it is in good operating
condition (see Integrity check, p. 14).
6.2 Reprocessing
Warning
Reprocessing shall be done before the first use, then after each use, as well as prior to maintenance, service
and disposal to prevent cross-contamination.
Caution
Before any reprocessing, unplug the scanner from power outlet.
Always handle the handpiece with great care as it contains fragile components. Dropping the handpiece on
the floor may damage it permanently.
Appendix A - Reprocessing of the handpiece and Appendix B - Reprocessing of cart and accessories contain further
details on how to reprocess the device.
The instructions given have been validated by Dental Wings2 as being capable of preparing the Intraoral Scanner
for re-use. 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.
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 Settings icon from the taskbar, then the System Settings submenu.
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.
1 The term high-level disinfection is used in this manual to refer to the method used to reprocess semicritical areas, the term low-
level disinfection is used to refer to the method used to reprocess noncritical areas. Both are known as disinfection in certain
territories.
2 Appendix A has also been validated by an independent, government accredited and recognized test laboratory.
1. Using a small flathead screwdriver (approx. width 4 mm), lever out the insert.
2. Change the corresponding fine fuses.
3. Reassemble.
6.5 Service
Caution
Reprocess prior to service to prevent cross-contamination.
To reduce the risk of electric shock, do not remove the cover (scanner top panel). 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 national law. A risked based approach taking the amount of usage into account 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.29).
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.
The scanner initialization failed. Ensure that the handpiece is properly connected and restart the device.
Integrity check failed... Restart the integrity check and ensure that you follow the procedure.
The connected handpiece has been qualified The scan accuracy of the connected handpiece is not sufficient for
for demonstration only, not for clinical use. patient cases.
Database
Database backup execution failed. Try to export in a different folder and/or a different file name.
Implant kit / ipflib file errors. Select a valid implant kit file.
Software
Server errors.
Case export failed. Try to export in a different folder and/or a different file name.
Scanning
Scanned area too small for meshing. Scan more tooth surface before proceeding.
This case is not ready to export. Complete the scan workflow before exporting the case.
The scan has been interrupted to prevent Wait one minute to let the handpiece cool down and then resume
overheating... scanning.
DWOS Connect
No internet connection...
Check internet connection.
Server not found/not reachable...
Bad configuration for remote server. Check that the DWOS Connect configurations are valid.
Check if the case is in the upload queue in the workspace screen. If yes,
This case is not in queue.
restart the device and try again.
Check if the case is in the upload queue in the workspace screen. If not,
This case is already in queue.
restart the device and try again.
If you did not cancel the upload on purpose, restart the device and try
Upload was canceled.
again.
Please select a supplier... Select a supplier in the export screen and export the case again.
Failed to upload case... Will automatically Wait until it automatically retries. If it still fails, restart the device and try
retry later. again.
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.
1 2 3 4
5 6
Refer servicing to authorized service personnel. Contact your local distributor if your scanner needs to be
repaired or if you need technical support for the scanner software.
Technical data
IPX5 (semicritical area - protection against low pressure jets of water from all
Protection class (acc: IEC 60529)
directions); IPXO (noncritical area - no protection)
Ambient conditions
LED light
Optical technology High-speed measuring cameras
Video cameras
No restrictions apply, surface coating required (see Accessories and products used in combination,
Scannable material
p. 6)
Scanning accuracy 20 μm (single unit), 50 μm (full arch) according to Dental Wings testing standard
Scanner label
This is an example of the label on your device:
DWIO
Dental Wings Inc. Serial Number: DWIOC-YY-ZZZZZZ
2251 Letourneux Type/Model Number: DW-IO-001
2016 Montréal (Québec) Input: 100-240V~, 50-60Hz, 540VA
H1V 2N9 Canada Fuse: 2 x M6AH250V
Made in Canada
CLASS 1
kg 35 total weight
with cart
LASER PRODUCT
Replacement or additional
Handpiece n 6100-1 handpiece for the Intraoral
Scanner.
Standard see-
Standard see-through
through
e.g. Tyvek® 90 mm x sterilization pouch to protect the
Sterilization n
200 mm, single use semicritical area of the
Pouch (90 mm x
handpiece.
200 mm)
Standard Plastic
e.g. Tyvek® 300 mm x Standard plastic bag to store the
Bag (250 mm x n
450 mm, single use complete handpiece.
400 mm)
Laser radiation
CLASS 1
LASER PRODUCT
Class 1 laser product acc. to IEC 60825-1
Direct current
~ Alternative current
Device fulfills the requirements of Machinery Directive 2006/42/EC, Low Voltage Directive
2006/95/EC, Electromagnetic Compatibility Directive 2004/108/EC and RoHS 2011/65/EU
Compliance with U.S. Occupational Safety and Health standards as well as SCC requirements
(Canada)
Caution: US Federal law restricts this device to sale by or on the order of a licensed health-care
practitioner
Device includes a radio frequency transmitter; interference may occur in the vicinity of
equipment marked with this symbol
total weight
Device weight is as indicated in the label, no working load permitted.
kg with cart
Humidity limitation
Precautions
n Never immerse the handpiece completely in liquids. Never immerse deeper than indicated in the User Manual.
n Be very careful when rinsing the handpiece. Make sure that the rinsing covers the entire area immersed in chemicals.
n While rinsing, pay particular attention to the cable strain relief. Liquids would easily enter there and damage the
handpiece.
n Do not use abrasive cleaners.
n Scratches on the optics cause damage to the handpiece. Be very careful in applying the soft, nylon-bristled
toothbrush. Do not rub cloth against optics. Use a blotting motion.
n Brushing can only be conducted outside the bottle. Protect personnel and surroundings from contamination.
n Do not use corrosive cleaning agents or disinfectants with acids, bases, oxidizing agents, and solvents (with
exception of simple alcohol).
n Ensure that the packaging for storage is large enough to contain the handpiece without excessively bending the
cable.
n Make sure the handpiece is completely dry before storage or assembly to the cart.
Limitations on reprocessing
Repeated reprocessing has minimal effect on the handpiece. End of life is normally determined by damage and wear due
to use. Reprocessing validation has been done for 250 cycles. We strongly recommend that the user regularly inspect the
handpiece. User is solely responsible for issues arising from the use of a damaged or worn handpiece.
n Enzymatic detergent1 intended for cleaning of medical devices made of metal, glass and plastics
n High-level disinfectant1 (for outside US: disinfectant with at least mycobactericidal effectiveness); intended for
disinfection of medical devices made of metal, glass and plastics; proven efficiency (e.g. FDA clearance,
VAH/DGHM listing, CE marking)
n Low-level disinfectant1 (for outside US: alcohol-based 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 Potable tap water (unless national regulation requires differently)
n Soft, lint-free, non-abrasive, disposable cloth
n Soft, nylon-bristled toothbrush
n Reprocessing station with bottles
Instructions
Point of use
n Immediately remove excess soil within semicritical area using a soft, lint-free, non-abrasive, disposable cloth.
1 Use only the validated cleaning products that are detailed at the end of this Appendix (p. 42).
Cleaning: Automated
1 Use only the validated cleaning products that are detailed at the end of this Appendix (p. 42)
Cleaning: Manual
1. Clean noncritical area of handpiece with a soft, lint-free, non-abrasive, disposable cloth, moistened with potable
tap water.
2. Secure the cable on the backside of the reprocessing station (Figure C).
3. Immerse semicritical area of handpiece in the bottle with enzymatic detergent1 and soak as
described in its instructions for use.
4. Unless no residues are visible, thoroughly brush semicritical area of handpiece completely
with a soft, nylon-bristled toothbrush.
5. Thoroughly but very carefully rinse semicritical area of handpiece completely under potable
tap water (Figure D). Conduct rinsing three (3) times, each for a minimum of one (1) minute in
duration. Turn handpiece repeatedly while rinsing.
6. Dry using a fresh, soft, lint-free, non-abrasive, disposable cloth, beginning at the semicritical
area of the handpiece. Use a blotting motion for the optics.
Disinfection: Automated
Disinfection: Manual
1. Apply low-level disinfectant1 to noncritical area of handpiece as described in its instructions for use.
2. Secure the cable on the backside of the reprocessing station (Figure E).
3. Immerse semicritical area of handpiece in the bottle with high-level disinfectant1 and soak as
described in its instructions for use.
4. Thoroughly but very carefully rinse semicritical area of handpiece completely under potable
tap water (Figure D). Conduct rinsing five (5) times, each for a minimum of one (1) minute in
duration. Turn handpiece repeatedly while rinsing.
5. Dry using a fresh, soft, lint-free, non-abrasive, disposable cloth, beginning at the semicritical
area of the handpiece. Use a blotting motion for the optics.
Drying
1 Use only the validated cleaning products that are detailed at the end of this Appendix (p. 42)
Maintenance
n Visually inspect for damage and wear (e.g. for scratches, discoloration, corrosion).
n Check in particular that there is neither clouding nor scratches on the optics.
n In case of doubt, conduct an integrity check (see User Manual).
n Replace handpiece in case of damage and wear (e.g. deep scratches, corrosion, failed integrity check).
Sterilization
Sterilization must not be applied to handpiece and is not required (handpiece is classified semicritical/noncritical).
Packaging/Storage
n Cover semicritical parts of the handpiece with an open see-through sterilization pouch. A size of 9 cm x 20 cm is
required.
n In addition, a standard plastic bag may be used to store the handpiece. A minimum size of 25 cm x 40 cm is
required.
Additional Information
The User Manual contains more detailed descriptions and figures on disconnecting from and connecting to cart,
integrity check, transportation, handling (including storage), disposal, technical data, ambient temperature etc.
Manufacturer Contact
Fundamental suitability of the handpiece (initial state and after 250 cycles) and the instructions provided above
for effective high- level disinfection has been validated by an independent government accredited and
recognized test laboratory using Cole-Parmer Graduated bottle PP (write on, wide mouth, 250 ml, Item # WE-
06041-14) as part of the reprocessing station, CIDEZYME® and Cidex® OPA Solution (both ASP Johnson &
Johnson).
The instructions given have been validated by Dental Wings as being capable of preparing the Intraoral
Scanner for re- use. 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.
Precautions
Limitations on reprocessing
Repeated reprocessing has minimal effect on the cart and accessories. End of life is normally determined by damage and
wear due to use. Reprocessing validation has been done for 250 cycles. We strongly recommend that the user regularly
inspect the cart and the accessories. User is solely responsible for issues arising from the use of damaged or worn cart
and accessories.
n Low-level disinfectant1 (for outside US: alcohol-based 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 Soft, lint-free, non-abrasive, disposable cloth
Instructions
Point of use
n Select specific low-level disinfectant1 according to its instructions for use. Follow it in terms of storage,
concentration, application and temperature.
n Unplug cart (see User Manual).
Cleaning: Automated
Cleaning: Manual
Clean noncritical area as described in the low-level disinfectant’s instructions for use. Use a soft, lint-free, non-abrasive,
disposable cloth for wiping.
Disinfection: Automated
Disinfection: Manual
Drying
Maintenance
1 Use only the validated cleaning products that are detailed at the end of this Appendix (p. 46)
n Visually inspect for damage and wear (e.g. for scratches, discoloration, corrosion).
n In case of doubt, conduct an integrity check (see User Manual).
n Replace components and accessories with signs of damage and wear (e.g. with deep cracks).
Sterilization
Sterilization must not be applied for cart and accessories and is not required (cart and accessories are classified
noncritical).
Packaging/Storage
No requirement in particular.
Additional Information
Manufacturer Contact
Non- detraction of functionality was demonstrated in 250 cycles using Isopropanol 70% (Jedmon Products
Ltd.).
The instructions given have been validated by Dental Wings as being capable of preparing the Intraoral Scanner
for re-use. 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.
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.
RF emissions CISPR 11 Class B The Intraoral Scanner is suitable for use in all
establishments, including domestic establishments and
Harmonic emissions IEC 61000-3-2 Class A
those directly connected to the public low- voltage power
Voltage fluctuations/ flicker emissions supply network that supplies buildings used for domestic
Complies
IEC 61000-3-3 purposes.
Table 1
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
0% UT ; 0,5 cycle
0% UT ; 0,5 cycle at 0°, Mains power quality should be that of
45°; 90°, 135°, 180°, at 0°, 45°; 90°, 135°, a typical commercial or hospital
225°, 270°, and 315° 180°, 225°, 270°, and environment. If the user of the Intraoral
Voltage dips and 315° Scanner requires continued operation
interruptions 0% UT; 1 cycle and
0% UT; 1 cycle and during power mains interruptions, it is
IEC 61000-4-11 70% UT; 25/30 cycles recommended that the Intraoral
70% UT; 25/30 cycles Scanner be powered from an
Single phase: at 0°
Single phase: at 0° uninterruptible power supply or a
0% UT; 250/300 cycles battery.
0% UT; 250/300 cycles
NOTE UT is the a.c. mains voltage prior to application of the test level.
Table 2
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.
Electromagnetic
Immunity Test IEC 60601 test level Compliance level
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.
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 3 V/m.
Table 3
P d E
Band
Service Max. power Distance Immunity test level
(MHz)
(W) (m) (V/m)
5100-
WLAN 802.11 a/n 0.2 0.3 9
5800
Table 4
The Intraoral Scanner is intended to be use 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.
power of transmitter 150 kHz to 800 MHz 800 MHz to 2,7 GHz 380 MHz to 5,8 GHz
(W) d = 1,2 √ P d = 2,3 √P d = 6/E √P
100 12 23 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
A Technical File has been compiled in accordance with the requirements set out in the applicable directives. The
Technical File is available with our authorized representative: Dental Wings GmbH, Düsseldorfer Platz 1, 09111
Chemnitz, Germany.
To verify the requirements of the directives, the following harmonized standards were applied:
IEC 60601-1:2012 / EN 60601-1:2010
IEC 60601-1-2:2014 / EN 60601-1-2:2010
IEC 60601-1-6:2013 / IEC / EN 62366:2014
IEC 62471:2006 / EN 62471:2008
IEC / EN 60529:2013
IEC / EN 60825-1:2007
ISO 10993-1:2009 / EN ISO 10993-1:2010
ISO /EN ISO 17664:2004
The appropriate conformity assessment procedures were carried out in accordance with the applicable directives.
Valid for:
DWIOC-03-000006 and higher
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