Indications for Use ..............................................................................................................................................6
Moving/Viewing the 3D Model ................................................................................................. 8
Using the Mouse..................................................................................................................................................8
Rotating the Model .................................................................................................................................... 8
Changing the Model Size ........................................................................................................................8
Moving the Model ...................................................................................................................................... 9
System Options and Default Settings ...................................................................................... 9
The Settings Screens ..........................................................................................................................................9
Version ............................................................................................................................................................9
Auto or Occlusal POI ............................................................................................................................... 10
Relocating the Laptop and/or Scanner .................................................................................. 11
System Information and Upgrades ........................................................................................11
Software and Hardware ................................................................................................................................. 11
Connecting the Scanning Tip .................................................................................................. 11
Disconnecting the Scanning Tip ............................................................................................. 11
Cleaning the Scanner Tip .........................................................................................................12
Tip Identication ...................................................................................................................................... 12
Instructions for Autoclaveable Tips ........................................................................................................... 13
Instructions for High Level Disinfection Tips ..........................................................................................14
Managing Patients in Planmeca Romexis .............................................................................. 17
Creating new patients .................................................................................................................................... 17
Scanning Tip Sizes ............................................................................................................................................ 21
Color Indicator .......................................................................................................................................... 22
Model Alignment ..................................................................................................................... 32
Rotating the Models ........................................................................................................................................ 33
Scanning a Pre-op .................................................................................................................... 34
Positioning the Scanner ................................................................................................................................. 35
Scanning the Impression ............................................................................................................................... 36
Margin Aids ........................................................................................................................................................ 38
Show Features .......................................................................................................................................... 38
Creating the Margin ........................................................................................................................................ 38
Exporting Data ........................................................................................ 45
Exporting a CAD/CAM Case ..................................................................................................... 45
Exporting 3D Models ............................................................................................................... 45
3D Model Export .............................................................................................................................................. 45
UL Listing............................................................................................................................................................. 55
UL Medical Equipment Listing ............................................................................................................ 55
The Planmeca FitTM System is a complete optical impression system for CAD/CAM of dental
restorations intended for dental oces or laboratories. The system comprises a Planmeca
PlanScan digital impression scanner, Planmeca Romexis CAD/CAM design software module,
and Planmeca PlanMill40 mill.
The Planmeca PlanScan scanner takes digital impressions which can be designed and
customized on the Planmeca Romexis CAD/CAM design software. The impressions can be sent
via Planmeca Romexis Cloud to Planmeca or a certied laboratory for design and milling or
exported to a third party.
Note: Caution: US Federal law restricts the Planmeca PlanScan to sale by or on the
order of a dentist.
The Planmeca Fit System requires Planmeca Romexis software revision 3.4.0.R or later.
Associated Documentation
Planmeca Romexis User’s Manual (publication number 10014593).
Note: Throughout the documentation, important notes and items of interest are
formatted like this example.
Warning The orange Warning denotes something that can cause personal injury or
physical damage to the equipment.
Some of the screenshots may have been taken in earlier software versions and may not exactly
match your screen.
Indications for Use
The Planmeca PlanScan System is an optical impression system for CAD/CAM of dental
restorations. It is a device used for recording topographical characteristics of teeth, dental
impressions, or stone models by digital methods for use in computer aided design and
manufacturing of dental restorative prosthetic devices.
Contraindications
The Planmeca impression system is not indicated for orthopedics or any indication beyond
dentistry.
6IntroductionPlanmeca PlanScan User Manual
Turn ON Laptop
Press the power button to start the laptop.
The Windows 8 Start screen appears. On your keyboard, press the key to make the
standard desktop appear if desired.
Opening Romexis
Click the Romexis icon on your desktop to open the software.
Scanner
Removable Components
The PlanScan system has a set of removable components.
Connecting the Thunderbolt™ Adapter
Properly connecting and disconnecting the scanner prevents damage to your devices.
1 Insert the Thunderbolt adapter into the adapter slot on the side of the
laptop. (The adapter should remain attached, even when not in use.)
2 After opening the Scan tab, connect the red FireWire connector of the
scanner into the white Thunderbolt™ adapter.
The laptop gives an audible signal to conrm that the connection is fully
seated.
To remove the scanner, hold the red end with one hand and with
the other hand grasp the Thunderbolt adapter. Gently pull apart to
disconnect. Leave the white Thunderbolt adapter attached to the
computer.
Disconnecting the Thunderbolt™ Adapter
If you wish to remove the adapter from the laptop:
1 Disconnect the scanner and exit Romexis to the Windows desktop.
2 Navigate to the Eject Media icon in the lower left corner of the desktop.
3 Click the icon and choose Eject IEEE 1394 Controller.
4 Remove the Thunderbolt adapter from the laptop.
Note: Failure to follow this procedure may result in an inoperable scanner.
For additional questions or concerns please contact Customer Support at
800.537.6700.
10828200.B Introduction7
Scanner Indication Lights
There are colored LED lights in the button on the scanner.
• Green - Ready for Use. Scanner is connected, but not actively scanning.
• Blue - Laser ON. Scanner is actively scanning.
If scanner light is not illuminated, the scanner is not ready or it is not connected.
Cradle
The system comes with a standalone cradle for the scanner.
The cradle can be separated and inserted into a 5/8 inch (16 mm) holder in your operatory
equipment (i.e. the slow speed suction holder).
Moving/Viewing the 3D Model
Use the mouse to zoom in or out, move, and rotate the composite model.
Using the Mouse
Rotating the Model
1 Click and hold down the right mouse button.
2 Drag the mouse horizontally, vertically, or diagonally to
rotate the image.
Drag in small increments for more control.
3 Release the mouse button to stop rotating. Repeat as needed.
Changing the Model Size
Use the scroll wheel on the mouse to zoom in and out
on the model.
1 Position the pointer on your model.
2 Rotate the mouse wheel downward, toward your wrist.
3 Rotate the mouse wheel upward, away from your wrist.
Rotate Model
press and hold the
right button, then
drag
Zoom Model
rotate the wheel
button to change the
size of the model on
the screen
8IntroductionPlanmeca PlanScan User Manual
The model becomes larger.
Moving the Model
The model can be moved without being rotated.
1 Position the pointer on the model.
2 Press and hold down the mouse wheel.
3 Drag the model to the desired position and release the
mouse wheel.
System Options and Default Settings
Individual tabs are used to design the restoration: Setup, Scan, Margin, Design, and Mill. The
tabs are dynamic. The choices you make on each tab aect the options available on that and
related tabs. The typical restoration utilizes the tabs from left to right. Moving backwards in
the process (e.g., modifying the settings in the Margin tab after completing the design in the
Design tab) can cause settings and designs to be discarded. The system warns you when your
actions will cause design data to be discarded.
Some system congurations will restrict the use and access of individual tabs.
Screenshots
Save an image of the screen for communicating with associates or Customer Support. To take
and save a screenshot:
ASUS: Press + Prt Sc keys simultaneously.
HP: Press + Fn + Prt Sc keys simultaneously.
Move Model
up/down, left/right:
press and hold the
wheel button, then
drag.
The computer takes a screenshot and saves it in Libraries - Pictures - Screenshots.
The screenshots are automatically numbered. You can rename them if desired.
The Settings Screens
Click the Settings button on the CAD/CAM screen or
the Settings button on each tab. These screens contain
preference settings that modify the default behavior of the
software. The settings are based on each screen. Use the
arrows to scroll right or left. Click a category to select it.
Selected categories display in the bottom of the screen.
Click Restore Factory Defaults to revert to original settings,
click Save to save changes, or click Cancel to exit without
saving.
Version
Displays the version of the software and imaging systems.
Reset Warnings
The warning and reminder screens have an option to Do Not Show This Message Again. If a
new operator is using the system, you can reactivate these warnings.
10828200.B Introduction9
Sprue Angle Method
(For mill systems)
Margin Ramp
(For design systems)
Spacer Thickness
(For design systems)
Dropper Tool
(For design systems)
Spaceball Settings
(Optional accessory)
Network Settings
This screen should be used only under the supervision of a customer service representative.
These settings are pre-congured and should not be changed.
Workbook Exercises
(For Classic systems)
Mill Notication Settings
(For Classic systems)
Milling Settings
(For mill systems)
Auto or Occlusal POI
(For mill systems)
10IntroductionPlanmeca PlanScan User Manual
E4D
Planmeca
2
Administration
This chapter describes the administrative functions associated with the Planmeca PlanScan
System.
Relocating the Laptop and/or Scanner
The laptop can be unplugged and moved as needed. The software does not need to be shut
down. The scanner can be disconnected at any time.
System Information and Upgrades
Software and Hardware
System software and hardware upgrades are initiated through Planmeca only. Nosoftware or
hardware should be added or deleted to/from the Planmeca systems without prior approval of
Planmeca. Doing so may result in damage to the system and will void the product warranty.
Connecting the Scanning Tip
(After disinfection if scanning intraorally. See insert with scanning
tips for further details.)
1 Grasp the body of the scanner with one hand.
2 Use the other hand to press the scanning tip onto the scanner as
shown. A locking click is heard once the tip is fully seated.
Disconnecting the Scanning Tip
1 Grasp the body of the scanner with one hand.
2 With your other hand depress the green button on the
underside of the scanner. Gently pull the tip from the
scanner.
To prevent damage to the scanner, pull the pieces
apart gently and without twisting or bending.
When the scanner is not in use, place the non-functional protective scanner tip on the scanner.
(Included with the scanner during shipping.)
Note: Failure to follow this procedure can in damage to scanner and scanningtip.
10828200.B Administration11
Cleaning the Scanner Tip
For intraoral scanning systems only.
The following instructions are for the removable tip of the scanner. It is not for the entire
scanner. See “Cleaning the System” on page 14 for cleaning the base of the scanner.
The scanning tips have been manufactured and tested for specic disinfection protocols.
Operational, maintenance and replacement instructions should be followed for the
product to perform as designed. Cleaning the scanner tip incorrectly may result in
incomplete disinfection and/or permanent damage to the tip.
Tip Identication
Autoclave Tips have the autoclave
symbol. See “Instructions for
Autoclaveable Tips” on page 13.
Note: Autoclavable tips compatible with PlanScan version 5.5 or later.
High Level Disinfection Tips have no
symbol. See “Instructions for High Level
Disinfection Tips” on page 14.
12AdministrationPlanmeca PlanScan User Manual
Instructions for Autoclaveable Tips
DO NOT use a chemical sterilant on tips with the autoclave symbol.
DO NOT Autoclave tips without the autoclave symbol.
DO NOT place in Ultrasonic Cleaner.
Excessive cycle times may prematurely reduce the life and function of the tip.
Note: These instructions were validated using a Class B autoclave and the
sterilization pouch HSD # 112-4854 with a minimum cycle of 132° C (269°F) with a
sterilization time of 5 minutes. You may use an autoclave pouch with comparable
materials and the same dimensions.
Look for the temperature symbol engraved on autoclaveable
tips. If the tip does not have this symbol, see “Instructions for
High Level Disinfection Tips” on page 14.
1 Clean the tip for 2 minutes under running tap water to remove
debris.
2 Individually pouch each scanner tip using an autoclave pouch
(ex. HSD # 112-4854 or a comparable product).
Note: Autoclave baskets are not indicated for this cleaningprocedure.
3 Place one to three pouches per tray or cassette.
4 Select the Wrapped, Wrapped Instruments, or Pouch cycle on the autoclave with a minimum
cycle of 132° C (269° F) with a sterilization time of 5 minutes. After cycle completion, store for
later use.
Note: Autoclave cycle names dier among manufacturers. Autoclave cycle times
exceeding 10 minutes could be considered excessive and may damage the
internal components and pin connector points. Referenceyour manufacturer’s
manual to select the cycle for sterilizing wrappedinstruments.
5 Prior to scanning, visually conrm the scanning
mirror and scanner connection points of the
scanning tip are clean and dry. To clean either
surface, use an optical cloth or 2x2 gauze with a
small amount of alcohol to gently remove residue.
Ensure each surface is dry before connecting it to
the scanner.
10828200.B Administration13
Instructions for High Level Disinfection Tips
DO NOT use a chemical sterilant on tips with the autoclave symbol.
DO NOT Autoclave tips without the autoclave symbol.
DO NOT place in Ultrasonic Cleaner.
Note: These instructions were validated using MaxiCide Plus w/ Activator (3.4%
Gluteraldehyde) disinfectant available from Henry Schein Dental (#102-2865).
1 Clean the tip for 2 minutes under running tap water at 22 - 25°C (4 liters/minute) to remove
debris.
2 Test the potency of your activated MaxiCide Plus prior to disinfection. (Recommend MetriTest
Strips by Metrex (HSD #602-3437)
3 Immerse the tip in activated MaxiCide Plus for 120 minutes (2hours).
Note: Do not leave the tips soaking overnight.
4 Remove tip from the disinfectant.
5 Rinse disinfected part in three separate copious amounts of distilled water (1000ml volume of
water; minimum of 2” head height while part is immersed).
Agitate the tip in the water for 30 seconds and then let it stand in the water for another 30
seconds.
6 Repeat the agitation and soak in each of the other two containers with fresh distilled water.
Storage
1 Wipe water o mirror using non-woven optical wipes (recommend Kimwipes Lens Cleaning
#101-7070).
2 Optional: Insert tip into a sterilization pouch. (recommend Self Seal Sterilization Pouch 5 ¼” x
10” [200/box] #112-4854)
3 Store for later use.
4 Prior to scanning, visually conrm the scanning
mirror and scanner connection points of the
scanning tip are clean and dry. To clean either
surface, use an optical cloth or 2x2 gauze with a
small amount of alcohol to gently remove residue.
Ensure each surface is dry before connecting it to
the scanner.
Cleaning the System
For intraoral scanning systems only.
Protect the keyboard with a disposable barrier.
Cleaning Cycle: Before and after each use, clean all areas of the Planmeca PlanScan System.
14AdministrationPlanmeca PlanScan User Manual
Warning: Before and after each use, follow these instructions to disinfect the
Planmeca PlanScan System. Do not substitute any other cleaning solution or procedure.
Under no circumstances should you use any paint thinner, solvents, or harsh chemicals.
Use only a non-woven sponge or pre-moistened germicidal cloths when cleaning the
Planmeca PlanScan System.
1 Using a clean, non-woven sponge that has been saturated with a hospital grade, TB-rated
germicide or pre-moistened germicidal cloths, apply the germicide to the entire surface of the
scanner base, scanner holder, mouse, mousepad, and any other surfaces that you touch that
were not covered by a disposable barrier. Do not spray the germicide directly on the items and
do not submerge the scanner or mouse in the germicide.
2 Follow the germicide manufacturer’s instructions.
Additional Assistance
Go to http://e4d.com for videos and downloadable documentation. If you have questions,
please contact Customer Support at:
Toll Free 800-537-6070
E-mailcustomersupport@e4d.com
Fax972-479-1106
Hours of Operation
Web sitewww.e4d.com
7 am – 7 pm CT (Monday - Thursday)
8 am – 5 pm CT (Friday)
Mailing Address
D4D Technologies LLC dba E4D Technologies
650 International Pkwy
Richardson, TX 75081 USA
10828200.B Administration15
Planmeca
3
Scanning Safety
Warning: Failure to adhere to all safety warnings may result in personal injury, equipment damage, or
data loss.
Do not use the Planmeca products for any purpose other than its intended and labeled use.
To prevent electrical shock, do not open any sealed or user restricted access panels or connectors.
In case of emergency unplug the computer power cord from the wall or from the computer.
Do not make any unauthorized repairs or modications to the system software or hardware. This includes
installing unauthorized software on the host computer system or altering or bypassing any safety
switches or mechanisms. Changes or modications not expressly approved by Planmecacould void the
user’s authority to operate the equipment and/or void the warranty.
Do not install or operate the Planmeca products in an environment where an explosion hazard exists, e.g.,
high oxygen area.
Comply with all applicable regulations when disposing of waste materials from the Planmeca products.
Do not attach any equipment or devices to the Planmeca products unless their use has been specically
authorized by Planmeca or E4D Technologies.
Medical electrical equipment requires special precautions regarding EMC (Electromagnetic Compatibility).
The Planmeca products must be installed and placed into service according to the EMC information
provided in the documentation that accompanies the Planmeca products.
Portable and mobile RF (Radio Frequency) communications equipment can aect medical electrical
equipment.
The wireless components in the Planmeca products may be interfered with by other equipment,
even if the other equipment is fully compliant with CISPR (International Special Committee on Radio
Interference) emission requirements.
When possible, electrical equipment should not be used when adjacent to other electrical equipment.
If adjacent use is necessary, the equipment should be observed to verify normal operation in the
conguration in which it will be used.
When connecting the Planmeca components, use only the cables supplied with the products.
Failure to do so may result in increased electromagnetic emissions or reduced immunity to external
electromagnetic emissions.
If you suspect equipment malfunction or failure, discontinue using the Planmeca products and contact
Technical Support immediately. Do not attempt to make any repairs on the Planmeca products.
Read and comply with all safety, warning, and instructional labels on the Planmeca products.
Avoid eye exposure while using the color tip. LEDs contained in this device pulse at a frequency that may
elicit reactions in sensitive individuals. These reactions may include seizures.
16Scanning SafetyPlanmeca PlanScan User Manual
E4D
Planmeca
4
Patients
Managing Patients in Planmeca Romexis
Creating new patients
1 In Patient Management, click the Add Patient button.
The Add Patient screen opens.
2 Enter the necessary information and add a face photo if desired.
Note: The obligatory elds are in bold text. See the Romexis User Manual for more
information.
3 To save the patient into the database click the Save button in any section.
Note: The changes are not saved unless Save button is used.
Note: To view the newly created patient on the list, perform new patient search.
Searching Patients
Patients can be searched by ID or by name.
In Patient Management, type any part of the patient’s name or ID number into the Search eld.
Matching items automatically appear as you type.
Note: The system looks for the letters or numbers anywhere in the patient’s name
or ID. Angela, Angie, and Dangereld are all matches for “ang” in the Search eld.
Sorting patients
Patients in the patient list can be sorted by the Date their records were previously accessed,
their ID number, or their last Name.
10828200.B Patients17
To sort patients click the desired sort button.
Selecting and opening patients
1 Click the patient name in the patient list.
The patient’s le opens.
The name of the active patient is always visible in the upper right corner of the screen. Several
patient records can be open at a time but only one of the open records is active at a time.
To close the active patient click the Close Patient button.
To view all open patients click the arrow of the drop-down menu.
To select and modify another open patient, select the name from the drop-down menu.
2 Click Go to CAD/CAM in the Next Steps section at the bottom of the screen.
Managing Cases
1 Open the desired patient.
2 Click Go to CAD/CAM.
Select what you want to do:
• Start a new restoration - See below for more information
• Open an existing restoration - See below for more information
• Import 3D models - See Planmeca Romexis User’s manual for more information
• Export 3D models - See Planmeca Romexis User’s manual for more information
18PatientsPlanmeca PlanScan User Manual
Deleting Files
To delete an image (stl le) from the patient’s case les right-click on the le and select
Inactivate STL.
To delete a case from the patient’s case les right-click on the case and select Inactivate
restoration.
To reactivate or permanently delete a case from the database see the Romexis User Manual.
Starting a New Restoration
Setup tab
1 To start a new scan, click New Scan and Design.
Note: Click New Scan Only if you do not have a design license.
2 To open an existing scan or restoration (crown, inlay, onlay, etc.) double-click a case on the list
or click the Open Restoration button.
The case opens in the Planmeca PlanScan Setup tab.
Use the Setup screen to set the restoration type, occlusal data type, material, and tooth library.
If you open an existing restoration, many of these settings may already be selected.
Note: The Setup tab must be lled out for Margin, Design, and Milling. For Scan
Only cases, click the Scan tab at the top to skip the Setup tab.
See the PlanCAD manual for details on lling out the Setup tab.
10828200.B Patients19
Planmeca
5
Scan Tab Layout
Scanning
Warning The scanner is a high precision Class 2 laser scanning instrument. Always store the
scanner in its cradle when not in use. To prevent damage or misalignment, do not drop or strike
the scanner. Follow all stated precautions when using the scanner.
The scanner captures the restoration site with a laser system and delivers live images to the
monitor. As you capture images, the system creates a composite model, revealing any areas
that need further scanning.
Ensure the power cord is being used on the laptop while scanning.
1
1 Scan Type
2 Scanner Indicators
3 Model Editing Tools
4
4 Evaluation Tools
5 Alignment Tools
3
2
5
20ScanningPlanmeca PlanScan User Manual
Scanner Tips
Tip can be removed and disinfected while the next tip is being used. See “Cleaning the Scanner
Tip” on page 12 for more information.
Scanning Tip Sizes
There are three tip options for the scanner. The smaller tips are ideal for molar scanning.
• Standard - 15 x 20 mm
• Landscape - 12.7 x 9.2 mm
• Portrait - 12.5 x 11.8 mm
• Color - 15 x 20 mm
StandardLandscapePortrait
Standard size color tips have
a color symbol on the back.
Note: Color scanning requires a Color Activation Kit (sold separately). Contact your
local representative for upgrade details.
The live view shows the dierences in the scanning tips. The standard tip has a higher focal
point and captures more data at once. This can be a problem with active tongues. Landscape
has a horizontal eld of view and portrait is vertical.
StandardLandscapePortrait
Note: Landscape and portrait tips are compatible with PlanCad 5.5 and later. Call
Customer Support for update information 1-800-537-6070.
10828200.B Scanning21
Scanner Indicators
Icons in the lower-left corner of the screen indicate the status of the scanner.
Disconnected
Connected - Cold
Heating - Stage 2
Tip Disconnected
Heating - Stage 1
Ready
Portrait/Landscape Indicators
When a portrait or landscape tip is connected, an icon appears next to the scanner status.
Standard tips do not have an orientation icon.
PortraitLandscape
Session Usage
Session Usage is displayed above the scanner status icon and shows how long you have been
scanning on this particular case. This number refreshes each time the Scan tab is opened or
when you click the Refresh icon next to it.
Autoclave Indicator
The autoclave symbol indicates that an autoclave tip is in use.
Color Indicator
The color symbol indicates that a color tip is in use.
Scanning Speed
The speed can be adjusted if desired. Left is slower, right is faster.
22ScanningPlanmeca PlanScan User Manual
Note: This feature is only available on new tips.
Positioning the Scanner for the First Scan
Position the scanner along the mesial-distal axis with the tip of the scanner pointing towards
the distal. The axis follows the curve of the arch. The pictures below show good and bad
positions along the arch.
Rest the tip of the scanner gently on the teeth during scanning. This will give you the correct
focal depth for the scans.
Scanning Overview
Scan the restoration site using the Planmeca scanner to capture the image of the tooth
(pre-operative or wax-up), preparation, opposing teeth, buccal bite, and/or bite registration.
Scanning the restoration site requires proper site preparation, correct placement and
movement of the scanner, and a sucient number of scans to ensure adequate digitalization of
the restoration site. The basic steps are:
1 Click the Scan tab.
2 Click the desired scanning mode: Pre-op, Prep, Bite Registration, Opposing, or Buccal Bite.
• Pre-op - Used to utilize the patient’s existing dentition or a wax-up as the pre-op model for
creating the restoration.
• Prep - Used to scan the prepared site of the restoration. All free owing blood, saliva, and
10828200.B Scanning23
residue should be removed from the preparation site before scanning.
• Opposing - Used to scan the teeth on the opposite arch of the preposition. Scan the same
number of teeth as the preparation model to ensure good alignment.
• Buccal - Scan the buccal view of the preparation, adjacent teeth, and opposing teeth.
• Bite - Used if you have produced a bite registration for use in dening the occlusal anatomy.
This button is active when Bite Registration is selected on the Setup tab.
3 Shield the site from strong extraneous light sources (dental lights, sunlight, etc.).
4 Click the button on the scanner to activate the laser.
5 The Live View displays the scanning view with live feedback. Place the scanner so that the
camera is centered over the occlusal of the restoration site.
Note: The system assumes that the rst scan is taken from the occlusal. Ensure the
rst scan is taken at a 90 degree angle to the occlusal surface. If the rst scan is not
optimal, delete it and retakeit.
6 Continue taking scans until the composite model is fully formed.
7 Click the button on the scanner to deactivate the laser.
8 Evaluate the model. Scan more if needed.
9 Click Generate Model or press M on the keyboard to nish building the model.
10 Make adjustments as needed.
11 Select the next scan type.
12 Repeat the steps above.
13 Click the Margin tab or click the Next button when nished with scanning.
Scanning Live View
The system displays a model based upon the scan data. The Live View appears on the right and
the model builds on the left. Watch the model building on the left to see what information has
been captured and where you need to move the scanner.
An audio tone plays to indicate that the system is capturing data. The system changes the Live
View to orange and stops the audio feedback if you have moved too far and the system needs
data overlap.
Mute or change the volume on your laptop to change the audio feedback.
24ScanningPlanmeca PlanScan User Manual
The most recent scan added to the model displays with a color coding to indicate the focal
distance of the data added.
• Green - close to the tip
• Yellow/Orange - middle of the range
• Red - end of the range (far away from tip)
Note: Any color shown means the scanner IS capturing data. The colors only
correspond to the focal distance.
The building model rotates to match the Live View.
Click the button on the scanner to stop scanning.
A raw data model is displayed.
Rotate the model to look for low data areas in key areas: the preparation, interproximal
contacts, etc..
Fill in missing data where needed.
Click Generate Model or press M on the keyboard to create the 3D model. If you exit without
generating the model, the scans will be lost.
Click Data Density View to evaluate the model for low data. See “Checking Your Model For
Missing Data” on page 26 for more information.
For design purposes, you may want to acquire more details of the adjacent teeth. If extra scans
are desired, deactivate Data Density View to speed up the process. Reactivate when nished
scanning.
Scanning Options
Adjust Live View Window Size
While the Live View is active, The window size can be adjusted. By default, the Live View is large
enough to ll the height of the scanning window. To make it smaller, place the mouse cursor on
the left edge of the Live View. Right-click and drag the window to the desired size.
The Live View will return to the default size next time it is activated.
10828200.B Scanning25
Adjust the Scanning Field of View
The scanning area can be reduced if tongue, cheek, instruments, etc. are interfering with your
scans. Most clinical operators do not change the Field of View.
Click and drag the Field of View indictor to the desired setting. The examples below are with the
standard tip.
Evaluating Your Model
Checking Your Model For Missing Data
Click Data Density View to evaluate the model for low data. If multiple scans are needed,
deactivate this button to speed up the process.
1 Click Data Density View if it is not already activated. The model refreshes with the dark blue
and purple areas indicating the least data. Rotate the model to analyze it.
2 Dark areas on your restoration site and interproximal contact areas should be rescanned.
Look for colored areas on the prepared tooth, especially on the margin. The adjacent teeth
should have good data on the interproximal contact area, occlusal surfaces, and of the lingual
and buccal contours. Data below the height of contour is not as crucial on the adjacent teeth.
3 If areas lack detail, take additional scans.
26ScanningPlanmeca PlanScan User Manual
Eraser Tool
With a couple of additional scans, the example is greatly improved.
4 Click Data Density View again to return to the normal view.
5 Click the Margin tab or click the Next button when nished with scanning.
Use the Eraser Tool to remove parts of the scanned model. This can be used to remove
unnecessary data like extra teeth, tongue, cheek, etc. With this tool, you can also erase an area
that needs to be rescanned. If you spot a problem (i.e. the margin is partially hidden by cord or
tissue), you can erase that area, correct the problem on your model or intraorally, then rescan
just that area! You do not have to start over. Be sure to erase and rescan ALL areas that were
changed.
The Eraser is also used in the Pre-op and Bite Registration Time Saver tools (see following
sections).
Click the Eraser tool to deactivate it.
Note: Keep some of the buccal or lingual data when erasing. If you disconnect the
two halves of the model, half of the model will disappear. It is also recommended
that you not delete multiple teeth in a row. Large gaps in the model is not
Reset Model
Click the Undo Erase Erase button to reset the model if a mistake was made when erasing.
Delete Model
Click the Delete Data button to remove the model and start over.
10828200.B Scanning27
recommended.
Scanning Occlusion Data
The proposal’s occlusion can be evaluated and designed using:
• Bite registration
• Buccal bite and opposing dentition
• Pre-op (a waxup or existing anatomy before preparation)
Note: Exported cases usually need to include Buccal/Opposing scans.
On the Setup tab, select Bite Registration or Buccal/Opposing. If you are scanning a pre-op,
leave the default to Buccal/Opposing.
The system will allow you to use a Time Saver method of copying the model. In certain
scenarios, this enables you to duplicate a model under another heading. You can then erase the
data that needs to be replaced and take fewer scans than if you are doing a completely new
scan.
• Pre-op model can be copied into Prep model
• Prep model can be copied into Bite Registration
The instructions below assume that you will use the Time Saver method. You always have the
option of simply doing a full scan for each model type.
Scanning a Bite Registration
A bite registration can be used to optimize occlusion for proper alignment with the opposing
tooth. Scan the preparation, ensuring there is enough detail of the adjacent dentition and/or
gingival tissue in your preparation scans to align the bite registration scans.
After scanning the preparation, prepare the bite registration.
Bite registration preparation
Keep the following recommendations in mind as you prepare bite registrations:
1 Place the bite registration material so that it completely covers the preparation surface.
• The bite registration material should not cover the adjacent teeth. If it does, trim to the
interproximal after the material sets.
• There must be sucient data of the adjacent teeth in the scans of the preparation and the
bite registration in order for the two models to align.
• Ensure there are no gaps between the bite registration material and the adjacent teeth.
28ScanningPlanmeca PlanScan User Manual
2 Have the patient bite down rmly or press the articulated model down rmly for the
impression.
3 If trimming of the bite is needed to expose more of the adjacent teeth, trim the bite in the
mouth. If you remove and replace it, the bite registration material may not seat properly.
Bite registration scanning
Goals
100% occlusal data
1 On the Setup tab, select Bite Registration.
2 On the Scan tab, click Scan Prep and scan the preparation model rst.
3 Click Scan Bite.
A Time Saver message appears. This message only appears when the preparation is scanned
rst. The Time Saver option allows you to duplicate the preparation model and use the same
data for the bite registration model.
Note: Time Saver cannot be used in conjunction with Impression Mode.
4 Click OK to use the Time Saver. If you do not wish to use the Time Saver option, the bite
registration and adjacent teeth can be scanned on their own. The following instructions assume
the use of the Time Saver option.
A copy of the preparation model is created in the bite registration model color.
10828200.B Scanning29
5 Click the Eraser Tool.
6 Erase the preparation and the marginal ridges of the adjacent teeth.
7 Click the Eraser Tool to deactivate it.
8 Activate the scanner and scan begin the scans with the occlusal of one of the adjacent teeth.
Once you have established where you are, you can begin scanning the bite registration data.
9 Scan the occlusal of the bite registration material and any of the adjacent tooth data that was
removed and is not covered by the bite registration.
Selecting the Bite Registration
Highlight the opposing dentition to designate which areas of this model should be used for
occlusion.
1 Click Bite Selection at the bottom of the screen. This icon only appears on the Scan Bite screen.
2 Click and drag to highlight the areas of the opposing dentition that would come into contact
with the restoration.
3 Click Bite Selection again to deactivate it.
30ScanningPlanmeca PlanScan User Manual
Note: Click Reset if you made a mistake and need to start over.
Scanning Buccal/Opposing
The opposing teeth are scanned to acquire bite information for the proposal. The buccal bite is
scanned to align the preparation model with the opposing model.
Scan Opposing
1 On the Setup tab, select Buccal/Opposing.
2 On the Scan tab, select Scan Opposing.
3 Starting with an occlusal view, scan the occlusal surfaces of the opposing dentition. Include the
same number of teeth as the preparation model. Ensure there is good cusp tip data on both the
lingual and buccal sides.
4 Roll to the buccal and scan the buccal side of the opposing dentition. Include gingival data, do
not stop halfway down the tooth.
Your model should resemble the following:
• Good occlusal data
• Good buccal data
• Good lingual cusps. Lingual axial data is not needed.
5 Erase extra data from the opposing model.
10828200.B Scanning31
Scan Buccal Bite
1 Click Scan Buccal Bite.
2 Press the articulated model down rmly or have the patient bite down rmly and tell them
not to move while you are scanning. If they shift during the scanning, the alignment may be
incorrect.
3 Scan at a 90° angle to the teeth. Scan the sides of the teeth that were captured in the
preparation and opposing models. Ensure some gingival data is captured.
4 Click Generate Model or press M on the keyboard. The system generates the model and
attempts to align to the other scanned models. The software should automatically align the
models. If the Align Buccal is red, see below for instructions on manually aligning the data.
Your model should resemble the following. Ensure there is good data on the buccal sides of the
teeth. Intraoral scans will most likely have the tongue in the background. Model scans will have
space ller in the gaps.
5 Erase any excess data from the model.
Model Alignment
The alignment icons are on the right side of the screen. There is a dierent icon for each
alignment type: Buccal Bite, Pre-op, and Bite Registration. The system attempts to automatically
align the models as they are generated. A green dot means the scans are aligned. A red dot
means they are not aligned.
Click the icon to view the alignment. All of the alignment icons have a Refresh button. Click
Refresh to reset the alignment and manually align the models. Automatic alignment should be
used in most cases.
If there is extra data that might be interfering with the scans (tongue, cheek, etc.), try trimming
the extra data before manually aligning.
The buccal bite model is translucent on the Alignment screen to aid in evaluation. The buccal
bite has an extra Show/Hide Buccal option. This enables you to hide the buccal bite model and
evaluate the opposing and prep models.
32ScanningPlanmeca PlanScan User Manual
To align models, drag and drop the buccal bite, pre-op, or bite registration over the prep model.
The models will snap into place or will return to their original positions.
In Buccal/Opposing cases, the opposing model appears after the prep and buccal bite are
aligned. Click and drag the opposing model to match the buccal bite model.
To access the menu options at the top or to return to scanning, deactivate the selected
Alignment icon. You cannot proceed if the Alignment icon is active (orange).
Rotating the Models
When necessary to aid in alignment, you can rotate the buccal bite or opposing model.
Note: The preparation model cannot be rotated, it is always stationary.
With the mouse cursor directly over the buccal or opposing model, right click and drag to
rotate.
With the mouse cursor on the background, right click and drag to rotate all of the models at the
same time.
Left click and drag to move the models on the screen.
Once the models are in good position in relation to each other, use the steps in the previous
section to align the models.
10828200.B Scanning33
Scanning a Pre-op
Use Scan Pre-op when you want to scan a pre-operative tooth or a wax-up. Pre-op scans can be
used in combination with the Library tooth or can be used as a template, like a bite registration.
1 On the Scan tab, click Scan Pre-Op.
Scan the pre-operative tooth or wax-up with the same scanning techniques used for the
prepared anterior or posterior tooth.
2 Prepare the tooth.
3 On the Scan tab, click Scan Prep.
A Time Saver message appears. This message only appears when the pre-op is scanned rst.
The Time Saver option allows you to duplicate the pre-op model and use the same data for the
preparation model.
Note: Time Saver cannot be used in conjunction with Impression Mode.
4 Click OK to use the Time Saver. If you do not wish to use the Time Saver option, the preparation
and adjacent teeth can be scanned on their own. The following instructions assume the use of
the Time Saver option.
A copy of the pre-op model is created in the preparation model color.
5 Click the Eraser Tool.
6 Erase the tooth that has been prepared and the marginal ridges of the adjacent teeth.
7 Click the Eraser Tool to deactivate it.
8 Activate the scanner and begin the scans with the occlusal of one of the adjacent teeth. Once
you have established where you are, you can begin scanning the preparation.
9 Scan the entire preparation and any of the adjacent tooth data that was removed.
34ScanningPlanmeca PlanScan User Manual
10 Click Generate Model or press M on the keyboard.
Scanning Impressions
Remove the excess impression material so that the scanner can get closer for scanning.
Note: Any impression material can be used. The system does not require a
particular color or type of material.
Positioning the Scanner
When scanning the impression, ensure the tip of the scanner is pointing towards the distal for
the initial scans so that the orientation of the model will be correct.
Due to the nature of impressions, the normal positioning of the scanner may not be able to
capture all of the walls of the impression. You can also tilt the scanner up or down or turn the
scanner perpendicular to the impression to achieve the necessary point of view.
10828200.B Scanning35
Scanning the Impression
Ensure the scanner is positioned correctly. See above for positioning. Be careful not to squeeze
or otherwise distort the impression while scanning.
1 On the Scan tab, select Scan Prep if it is not already selected. Do NOT select Scan Bite
Registration, which resembles an impression.
2 Use the same scan pattern as for an intraoral or a model scan.
3 Evaluate the model for low data.
Note that from the occlusal view, the impression can give the optical illusion of looking like a
regular model.
4 Rotate the model to see all of the impression. Be sure to check the contact areas on the
adjacent teeth.
5 If there are areas that need additional scans, such as the interproximal area shown above, take
extra scans.
6 Click Impression Mode to invert the model into the normal view. All other tabs will use the
inverted model of the impression for creating the proposal.
Note: A message appears; “Inverting the impression model will reset associated
margins and restorations. Are you sure?” Click Yes to invert the model.
7 Click the Margin tab and continue with the normal procedure for drawing the margin and
designing the proposal.
36ScanningPlanmeca PlanScan User Manual
E4D
Planmeca
6
Orientation
Margin Tool
Margin Tab
The Margin tab contains tools for quickly and easily creating and modifying the margin.
There are three tools on the Margin tab.
• Margin Tool
• Selection Area Tool
• Pre-op Editing Tool
The Orientation tool is automatically activated when you rst access the Margin tab. For Scan
Only cases, this step can be skipped. If you are going to design the case, see the Planmeca
PlanCAD manual for more information.
Clicking the Margin Tool activates the margin editing mode in which various methods are
available to create and edit the margin.
There are three aids available when working with the margin:
• View ICE Preparation
• Show Features
• Toggle Margin
There are three options for creating your margin:
• Paint - Create the margin using a broad brush stroke.
• Trace - Create the margin using individually marked points
along the edge.
• Lasso - Create the margin by marking several points along
the edge
Note: You can zoom and rotate the model while you are creating or editing the
margin.
After the margin is created, it can be edited using one or both of the following:
• Add Segments - Replaces existing segments of the margin.
• Move Margin - Adjusts the curve of the existing margin.
Margin Aids
View ICE Preparation
For intraoral cases only.
Use View ICE Preparation to toggle between ICE view and stone view.
Show Features
Click Show Features to highlight high contour areas in green. This can be helpful in nding the
margin edge on supragingival preps, inlays, and onlays.
Creating the Margin
When creating the margin, use either the Paint, Trace, OR Lasso tool. They are not used in
combination.
Paint tool
The Paint tool is recommended for supragingival margins.
1 Click the Paint tool.
The pointer changes to .
2 Hold down the mouse button and drag the Paint tool around the scanned prep to highlight the
outer margin edge. The margin doesn’t have to be perfect, but gaps must be avoided.
3 Click the Paint button again.
The system automatically draws the margin.
4 To delete the margin and start over, click the Paint, Trace, or Lasso
button.
38Margin TabPlanmeca PlanScan User Manual
Trace tool
The Trace tool can be used on any margin, but it is especially recommended for equigingival
and subgingival margins.
1 Click the Trace button.
The pointer changes to .
2 Click Show Features to highlight high contour areas in green.
3 Zoom in and rotate the model until there is a good view of the margin.
4 Position the Trace tool in the middle of the green high contour indication on the margin.
Note: Show Features is recommended as an aid in nding the edge of the margin,
it is not necessary for using the Trace tool. Draw the margin in the middle of the
green high contour indication.
5 Click on the margin. A dot appears as the starting point.
6 There are two options when drawing the margin with Trace.
• Click along the margin in small increments. The system creates straight lines between each
click.
• Hold down the left mouse button to draw a continuous line. Release the mouse at any time
to stop. This requires a steady drawing hand with the mouse and is not recommended for
beginners.
If desired, switch between small clicks and continuous lines.
7 Click the starting point to nish the margin. The system automatically changes the trace line to
a margin line.
Your margin should resemble the following.
8 To delete the margin and start over, click the Paint, Trace, or Lasso button.
10828200.B Margin Tab39
Lasso tool
The Lasso tool is recommended for partial restorations and supragingival margins with a sharp
edge.
1 Click the Lasso button.
The pointer changes to .
2 Click along the margin at large intervals. The system creates a line
along the edge between each click.
The starting point and the most recent point clicked appear as
blue dots.
3 Click to accept the previewed segment. Click the starting blue dot
to nish the margin.
4 To delete the margin and start over, click the Paint, Trace, or Lasso button.
Note: If Lasso is having trouble nding the margin, you can change the ICE Margin
Margin Tab Settings
ICE Margin Mode
Mode to Texture Only. See below.
For intraoral cases only.
ICE Margin Mode determines which view the system uses to create the margin curve when
using the Lasso tool.
1 Click Settings.
2 Click ICE Margin Mode.
The default setting, Normal, means that the system uses both the stone and ICE view to
determine where the Lasso line should appear.
3 Select Texture only to indicate that the system should ignore the stone model and focus on
the dierences in the ICE view. If View ICE Preparation is deactivated, this setting returns to
Normal mode.
4 Click Save to save the change or Cancel to exit without saving.
Modifying the Margin
The Margin tab provides two tools for modifying an existing margin path: Move Margin and
Add Segments.
Before selecting a tool, enlarge and position the model to ensure an optimal view of the margin
area. You can use either tool or both sequentially, they do not remove previous changes when
clicked like the margin drawing tools.
Toggle Margin
Once the margin is created, Toggle Margin shows or hides the margin. This is helpful in
verifying the margin has been drawn correctly.
40Margin TabPlanmeca PlanScan User Manual
Move Margin tool
Use the Move Margin tool to drag and drop a section of the margin into a new position.
1 Click the Move Margin button.
2 Position the pointer on the margin; click and hold down the mouse button.
Note: Area of Inuence - Change the tool’s area of inuence by dragging the
yellow button to increase or decrease the size of the ellipse.
3 Drag the margin onto the margin shelf and release the mouse button.
The system automatically redraws the margin in the new location.
4 Repeat as needed.
Add Segments tool
Use the Add Segments tool to redraw a portion of the margin.
1 Click the Add Segments button.
2 Start by clicking on a portion of the margin line that is acceptable. Then, click to add new points
across the gap in the line. A line traces where you click. Use multiple clicks to create a curve.
3 Click Add Segments. The system redraws the margin and removes the unacceptable section.
4 Repeat as needed.
Preview Library
Click Preview Library to display a preview of the library tooth on top of the preparation.
The size of the preview tooth is based on the margin. The tooth may appear small on partial
restorations. The preview tooth is positioned according to the Orientation. Click Orientation to
use the library tooth as a guide to change the model’s alignment.
10828200.B Margin Tab41
Retract
Use the Retract tool on STL export cases with a subgingival or equigingival margin. This tool
ditches the 3D model since the margin line does not convert to STL.
Note: ICE View is not converted to STL format and cannot be used as a visual aid
by the recipient of your case.
Without virtual ditching, the margin may be dicult for your recipient to see.
1 After the margin has been drawn and edited, click Retract.
The system virtually removes part of the model outside of the drawn margin.
Margin drawn - No ditchingMargin drawn - With ditching
Note: Any changes to the margin will require the ditching to be redone. If you are
doing a multiple restoration case, nish all of the margin edits before using the
Retract tool.
2 Click Toggle Margin to view the ditched area without the margin. This is similar to what your
STL recipient will see.
3 Click Toggle Retraction to show/hide the virtual ditching.
42Margin TabPlanmeca PlanScan User Manual
Multiple Restorations
On multiple restoration cases, the tooth number is assigned to each preparation when the
margin is drawn.
1 Click the desired tooth number tab.
2 Draw and edit the margin for the selected tooth number.
3 Select the next tooth number.
4 Draw and edit the margin for the selected tooth number.
Drawing the margins is how the tooth number is designated for each preparation. If the wrong
tooth number is selected when a margin is drawn, the margin must be marked again on the
correct tooth tab.
Note: See “Drawing Pontic Margins” on page 44 for information on margins for
bridges.
Selection Area Tool
For designing systems only.
5
10828200.B Margin Tab43
Drawing Pontic Margins
A margin is drawn for each tooth in the bridge.
1 Click the tooth number tab for each abutment and draw the margin on the selected tooth.
An edentulous space does not technically have a margin. The margin is drawn to aid the design
process.
2 Click Trace and designate the position and extension of the base of the pontic on the gingival
tissue to t the appropriate contour.
Note: Do not go too far down the curve of the gingival tissue or you may not be
able to t the bridge in the block.
44Margin TabPlanmeca PlanScan User Manual
E4D
Planmeca
7
Exporting Data
Note: The screenshots in this chapter are not created by E4D Technologies
and may have changed since this manual was published. Please see the
www.planmecausasupport.com for more information on Romexis.
There are several methods for sharing digital information using Romexis.
• CAD/CAM cases can be transferred between other PlanScan or E4D systems.
• STL les of CAD/CAM data can be exported as 3D Models to and from an external source.
• View images on an iOS device with iRomexis installed. See Romexis manual for more
information.
• Securly send cases over the internet using Planmeca Romexis Cloud services (see Romexis
manual) or send to a lab through DDX.
Exporting a CAD/CAM Case
1 To export a le to share with another Planmeca system, click File - Export - Export CAD/CAM
Case.
2 Select the destination folder and enter a le name. Click Save.
Romexis User Manual or
Exporting 3D Models
3D Model Export
To export 3D models in STL format click the case in the Patient’s Case Files list then 3D model
export.
1 Navigate to the desired destination folder. It is recommended to create a new folder on the
desktop to easily nd the les later.
2 Click Save
Note: For equigingival or subgingival margins, ensure you have used the Retract
margin tool. The drawn margin is not saved and the STL recipient will not be able
DDX Export
To send CAD/CAM or STL models via the DDX network to registered DDX Labs. See Romexis
User Manual for conguration instructions.
The recipient can import the STL les or the entire cad/cam case if they have our design
software.
to use ICE View to nd the margin. See “Retract” in Chapter 6.
10828200.B Exporting Data45
Sending Cases Through DDX
1 In the CAD/CAM module of the active patient, select the desired case le.
2 Click DDX Export.
If you are currently logged into DDX, you will see details of your other cases.
The available models for the case that you have selected are listed near the bottom of the
screen. Ensure you have a ditched_prep model if your case has equigingival or subgingival
margins. See “Retract” in Chapter 6 for more information.
3 Select STL (3D Models Only) or Native PlanCAD (All Data) as the export type at the bottom
of the screen. Labs must have Romexis PlanCAD software in order to use the PlanCAD data. Ask
your lab which export type they prefer.
4 Click Create a New Case.
Note: If you are not already logged into DDX, a login screen will appear.
5 Select the desired lab from the list of My Labs or Find A Lab.
6 Fill out the form. You must select a Procedure and type the tooth number(s). The rest of the
elds are optional.
7 Click Submit Case.
The system returns to the DDX Cloud screen. Wait for the case to appear in the Existing Files
section.
A red progress bar appears when the case automatically uploads. The screen closes when the
upload is nished.
Note: If the case does not automatically upload, click on the le in Existing Files
and click the Add Files button.
Note: A PlanScan panel is available in the Dentrix Chart. See Dentrix user manual
for details and instructions.
46Exporting DataPlanmeca PlanScan User Manual
E4D
Planmeca
8
Scanner Specifications
Australian Sponsor
Emergo Australia
Level 20, Tower II
Darling Park
201 Sussex Street
Sydney NSW 2000
Model Number: PlanScan
P/N: 12370003
Electrical Ratings: 12Vdc, 12W
Storage conditions: -29°C to 38°C (-20°F to 100°F)
Operating conditions:
20 °C to 28°C (67.5 °F to 82.5 °F) <90%
non-condensing relative humidity
maximum altitude 6,562 ft (2,000 m)
Dimensions:
Scanner with tip - 1.9 x 2.1 x 10.9 inches (48 x 53 x 276 mm)
Scanner without tip - 1.9 x 2.1 x 7.4 inches (48 mm x 53 mm x 188 mm)
Scanner tip - 1.6 x 1.9 x 4.8 inches (40.5 x 49 x 123 mm)
Weight:
Scanner with tip - 19 oz (544 g)
Scanner base - 18 oz (516 g)
Scanner tip - 1 oz (28 g)
Cables
When connecting components, ensure you use only the cables provided with the system. The
following cables were provided with the scanner.
FireWire to Thunderbolt Adaptor Cable: Shielded, Length 0.2M
Applicable Standards
Product Safety
ANSI/AAMI ES60601-1:2005
IEC 60601-1, 3rd Edition
EMC
IEC 60601-1-2
US FCC CFR 47, Part 15
Laser Product Safety
IEC 60825-1
10828200.B Scanner Specications47
Packaging and Environmental
ISTA Class 2A
Biocampatibility
ISO 10993
European Standards
EN 60601-1:2006
93/42/EEC Medical Device Directive
EN 60601-1:2006 Safety of Medical Electric Equipment
EN 60601-1-2 Electromagnetic Compatibility
EN 60825-1 Safety of Laser Products
EN ISO 14971:2012 Risk Management
EN ISO 13485 Quality Management Systems
EN ISO 10993: Biological Evaluation of Medical Devices
Canadian Standards
CAN/CSA C22.2 No. 60601-1:2008
SOR-98-282 Canada Medical Device Regulations
ICES-001 ISM Radio Frequency Generators
US Food and Drug Administration
US FDA CFR 21 Part 1040.10 Laser Products
US FDA Laser Notice 50
CFR 21, Part 820
FDA Class II Special Controls for Computer Assisted Design and Manufacturing of Dental
Restorations
International Standards
ISO 14971:2007
ISO 13485:2003
Approvals (All Systems)
North AmericaProduct Safety Mark (NRTL) - UL C/US
InternationalCB Scheme Product Safety Test Certicate (UL)
Quality System CerticationsISO 13485 Registered Firm
Complies with FDA performance standards for laser products, except for deviations pursuant to
Laser Notice No. 50, dated June 24, 2007.
This device complies with part 15 of the FCC Rules. Operation is subject to the following two
conditions: (1) This device may not cause harmful interference, and (2) this device must accept
any interference received, including interference that may cause undesired operation.
CB Scheme EMC Test Certicate (NEMKO)
CE Mark (TUV)
Japan GMP
48Scanner SpecicationsPlanmeca PlanScan User Manual
Note: This equipment has been tested and found to comply with the limits for a Class A digital
device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable
protection against harmful interference when the equipment is operated in a commercial
environment. This equipment generates, uses, and can radiate radio frequency energy and,
if not installed and used in accordance with the instruction manual, may cause harmful
interference to radio communications. Operation of this equipment in a residential area is likely
to cause harmful interference in which case the user will be required to correct the interference
at his own expense.
This ISM device complies with Canadian ICES-001. (Cet appareil ISM est conforme à la norme
NMB-001 du Canada.)
Warning: This is a Class A product. In a domestic environment this product may cause radio
interference in which case the user may be required to take adequate measures.
Guidance and Manufacturer’s Declaration - Electromagnetic Emissions
The PlanScan is intended for use in the electromagnetic environment specied below. The
customer or the user of the PlanScan should assure that it is used in such an environment.
RF emissions CISPR 11Group 1The PlanScan uses 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 11Class AThe PlanScan is suitable for use in all
Harmonic emissions IEC
61000-3-2
Voltage uctuations
/ icker emissions IEC
61000-3-3
Not
applicable
Not
applicable
establishments other than domestic
and those directly connected to the
public low voltage power supply
network that supplies buildings used
for domestic purposes.
Guidance and Manufacturer’s Declaration - Electromagnetic Immunity
The PlanScan is intended for use in the electromagnetic environment specied below. The
customer or the user of the PlanScan should ensure that it is used in such an environment.
Immunity TestIEC 60601 Test
Level
Electrostatic
discharge (ESD)
IEC 61000-4-2
Electrical fast
transient/ burst
IEC 61000-4-4
10828200.B Scanner Specications49
+/- 6 kV contact
+/- 8 kV air
+/- 2 kV for power
supply lines
+/- 1 kV for input/
output
Compliance
Level
+/- 6 kV
contact
+/- 8 kV air
Not
applicable
Electromagnetic
Environment - guidance
Floors should be wood,
concrete or ceramic tile.
If oors are covered with
synthetic material, the
relative humidity should be
at least 30%
Mains power quality
should be that of a typical
commercial or hospital
environment
Immunity TestIEC 60601 Test
Level
Surge
IEC 61000-4-5
+/- 1 kV
dierential mode
Compliance
Level
Not
applicable
+/- 2 kV common
mode
Voltage
dips, short
interruptions
and voltage
variations on
power supply
input lines
IEC 61000-4-11
<5% Ut
(>95% dip in Ut)
for 0,5 cycle
40% Ut
(60% dip in Ut) for
5 cycles
70% Ut
(30% dip in Ut) for
25 cycles
Not
applicable
<5% Ut
(>95% dip in Ut)
for 5 sec.
Power
3 A/m3 A/mPower frequency magnetic
frequency
(50/60 Hz)
Magnetic eld
IEC 61000-4-8
Note: Ut is the a.c. mains voltage prior to application of the test level.
Electromagnetic
Environment - guidance
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.
elds should be at levels
characteristic of a typical
location in a typical
commercial or hospital
environment.
50Scanner SpecicationsPlanmeca PlanScan User Manual
Immunity TestIEC 60601
Test Level
Conducted RF
IEC 61000-4-6
3 Vrms
150 kHz to
80MHz
Radiated RF
IEC 61000-4-3
3 V/m
80 MHz to
2.5GHz
Compliance
Level
Not
applicable
3 V/m
Electromagnetic Environment guidance
Portable and mobile RF
communications equipment should
be used no closer to any part of the
PlanScan, including cables, than the
recommended separation distance
calculated from the equation
applicable to the frequency of the
transmitter.
Recommended separation distance
where P is the maximum output
power rating of the transmitter
in watts (W) according to the
transmitter manufacturer and d is the
recommended separation distance
in metres (m). Field strengths from
xed 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 aected by
absorption and reection from structures, objects and people.
a. Field strengths from xed 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 xed RF transmitters, an
electromagnetic site survey should be considered. If the measured eld strength in the location in which
the PlanScan is used exceeds the applicable RF compliance level above, the PlanScan should be observed
to verify normal operation. If abnormal performance is observed, additional measures may be necessary,
such as reorienting or relocating the PlanScan.
b. Over the frequency range 150 kHz to 80 MHz, eld strengths should be less than 3 V/m.
Recommended Separation Distances
Recommended separation distances between portable and mobile RF
communications equipment and the PlanScan
The PlanScan is intended for use in an electromagnetic environment in which
radiated RF disturbances are controlled. The customer or the user of the PlanScan
can help prevent electromagnetic interference by maintaining a minimum distance
between portable and mobile RF communications equipment (transmitters) and the
PlanScan as recommended below, according to the maximum output power of the
communications equipment.
10828200.B Scanner Specications51
Recommended separation distances between portable and mobile RF
communications equipment and the PlanScan
Rated
maximum
output power
of transmitter
W
Separation distance according to frequency of transmitter m
150 kHz to 80 MHz80 MHz to 800 MHz800 MHz to 2.5 GHz
0.010.120.120.23
0.10.380.380.73
11.21.22.3
103.83.87.3
100121223
For transmitters rated at a maximum output power not listed above, the
recommended separation distance d in metres (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 aected by absorption and reection from structures, objects and
people.
PlanScan Optical Specications
Caution Using controls, making adjustments, or performing procedures in a manner other than
is specied in this documentation may result in hazardous radiation exposure.
Laser Class
Output4.95 mW
Wavelength450 nm
Beam divergence10 degrees
a. Laser product classied to standard IEC/EN 60825-1:2007-03 Ed. 2.0
The scanner’s laser projection system utilizes a divergent beam powered by a non-accessible
laser source with a maximum power output of 200 mW. The scanner incorporates design
features that prevent exposure to any hazardous levels of laser radiation in normal operation
modes and in any reasonable fault conditions.
a
Class 2
52Scanner SpecicationsPlanmeca PlanScan User Manual
Labels
Symbols
The following symbols are used on various labels on the system.
SymbolDenition
Authorized Representative in the European community
Class 2 electrical product
Date of Manufacture
DC Current
This product must NOT be disposed of with other waste. It is the user’s
responsibility to dispose of their waste electrical and electronic equipment
by handing it over to an approved reprocessor, or by returning it to E4D
Technologies for reprocessing. For more information about where you can
send your waste equipment for recycling, please contact your local city
oce or E4D Technologies.
European conformity
General mandatory action
General warning
Laser warning
Lot number
Mandatory Safety ISO 7010-M002
Manufacturer
Catalog number
Serial number
Standby IEC 60417-5010
Type B Applied Part IEC 60417-5840
10828200.B Scanner Specications53
Firewire Warning Label
PLANSCAN
LASER RADIATION
DO NOT STARE INTO BEAM
CLASS 2 LASER PRODUCT
450 nm, 4.95 mW CW
IEC/EN 60825-1:2007
PLANSCAN
There is a warning label near the Firewire connection.
DO NOT PULL
CABLE TO
DISCONNECT
BENDING
OR TWISTING
CABLE MAY IMPACT
SYSTEM USABILITY
Product Identication Labels
Axed to the scanner are product identication labels that contain identication and safety
information. Be certain to read all product labeling.
Note: If any of the labels are missing or illegible, please contact Planmeca After
Sales for replacement labels.
Note: The labels may have changed since this book was published.
54Scanner SpecicationsPlanmeca PlanScan User Manual
450 nm, 4.95mW CW
LASER RADIATION
IEC/EN 60825-1:2007
DO NOT STARE INTO BEAM
CLASS 2 LASER PRODUCT
LASER RADIATION
450 nm, 4.95 mW CW
DO NOT STARE INTO BEAM
IEC/EN 60825-1:2007
CLASS 2 LASER PRODUCT
External Components and Connectors
When connecting external components to the E4D system, attach only components that have
been tested for compliance with IEC 60601-1 or UL60950.
Connectors for attaching external devices conduct low voltages. Avoid touching the connector
pins.
Internal Fuse
FS2 - 1.5A/63V/FF/50A IR
UL Listing
UL Medical Equipment Listing
MEDICAL - GENERAL MEDICAL EQUIPMENT
AS TO ELECTRICAL SHOCK, FIRE AND MECHANICAL HAZARDS ONLY
IN ACCORDANCE WITH ANSI/AAMI ES60601-1 (2005)
CAN/CSA C22.2 No. 60601-1:2008
EN 60601-1 (2006)
IEC 60601-1-2
IEC 60825-1
30SD
10828200.B Scanner Specications55
Planmeca
9
Troubleshooting/Repair
If you have questions, please contact Customer Support at
Toll Free 800-537-6070
E-mailcustomersupport@e4d.com
Fax972-479-1106
Hours of Operation
Web sitewww.e4d.com
Mailing Address
SymptomProbable CauseCorrective Action
No powerPower cable unpluggedVerify power cable is plugged into a live AC
Outer power supply switch
turned OFF
Inner power supply switch
turned OFF
Login screen appearsScreensaver login turned ONGo to properties, then screen saver and turn it
Failing to send
restoration
Software freezingLow memoryRe-start application or re-start system.
Mouse not
responding
Low batteriesReplace batteries.
Loose mouse dongleEnsure dongle is plugged into a USB port.
7 am – 7 pm CT (Monday - Thursday)
8 am – 5 pm CT (Friday)
D4D Technologies LLC dba E4D Technologies
650 International Pkwy
Richardson, TX 75081 USA
outlet.
Set power supply rocker switch at rear of the
unit to “ON” position.
Ensure switch on power supply is turned ON.
(Call Customer Support)
OFF.
Call Customer Support.
56 Troubleshooting/RepairPlanmeca PlanScan User Manual
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