iTero Element 5D Plus - CFCC Compliance Information Statement (Sdoc)

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C FCC compliance information statement (SDoC)

We Align Technology Ltd. declare:

Type of equipment: The iTero Element 5D is an integrated intraoral imaging system capable of intraoral optical

impression for CAD/CAM of dental devices which also captures 2D color images, and Near Infrared (NIR) images.

Brand name or trademark: iTero Element 5D

Modular component used: Qualcomm Atheros, FCC ID PPD-QCNFA364AH complies with FCC requirements

according to Declaration of Conformity issued by Advantech Co., Ltd.

Country of origin: Israel

Manufacturer: Align Technology Ltd.

Responsible Party name (IN USA): Align Technology, Inc.

Address: 2820 Orchard Parkway San Jose, California 95134 USA

Telephone: +1 (408) 470-1000

Internet E-Mail: iterosupport@aligntech.com

iTero Element® 5D Plus User manual

Main Page

Table of Contents9
Introduction19
Intended Use19
Benefits19
Itero Element 5D Plus Hardware20
Figure 1: Front View of the Scanner20
Itero Element 5D Plus Wand21
Figure 2: Rear View of the Scanner21
Figure 3: Itero Element 5D Plus Wand21
Itero Element 5D Plus Software22
Figure 4: Protective Sleeve22
Figure 5: Wand Barrier Sleeve22
Working with Near Infra-Red Imaging (NIRI)23
Figure 6: Visible Light Spectrum Showing NIRI on the 850Nm Wavelength23
Figure 7: Reflective Concept - Healthy Enamel Is Translucent While Dentin and Caries Are Reflective23
Figure 8: Interproximal Carious Lesion24
Limitations25
About this Manual25
Getting Started27
Assembling the Itero Element 5D Plus Scanner27
Figure 9: Removing the Wand from the Cradle30
Figure 10: Moving the Scanner31
Figure 11: Do Not Lift the Scanner Using the Main Handle31
Logging in to the Scanner for the First Time32
Registering the Scanner - Make It Mine Process32
Figure 12: Welcome Screen32
Figure 13: Connect Page Listing the Available Networks33
Figure 14: Entering the Security Key34
Figure 15: Scanner Is Connected to the Internet and Online34
Figure 16: Verifying the Communication with Align35
Figure 17: Selecting the Time Zone35
Figure 18: Registering the System to Customize the Setup36
Figure 19: Itero Subscription Package36
Figure 20: License Agreement37
Figure 21: Checking for Updates37
Working in Demo Mode38
Figure 22: System Is Registered and Ready38
Figure 23: Itero Element Logo39
Figure 24: Demo Mode Option39
Figure 25: Login Window with a List of Demo Users40
Figure 26: Demo Login Button40
Figure 27: Demo Mode Home Screen41
Figure 28: Past Orders Pane - Options42
Exiting Demo Mode43
Figure 29: Exiting Demo Mode43
Working with the Itero Element 5D Plus Scanner45
Logging in to the Scanner45
Figure 30: Login Window45
Figure 31: Unexpected Shutdown Notification46
Figure 32: Itero Home Screen47
Resetting Your Password48
Figure 33: Forgot Password Button48
Figure 34: Email Field for Forgotten Password49
Figure 35: Security Answer Field49
Installing Windows Security Updates50
Figure 36: Login Window with Notification about Windows Security Updates50
Logging out of the Scanner51
Shutting down the Scanner51
Figure 37: Home Screen with Notification about Windows Security Updates51
Moving the Scanner52
Figure 38: Notification about Incorrect Scanner Shutdown52
User Interface53
Figure 39: Moving the Scanner53
Figure 40: Itero Home Screen54
Figure 41: Percentage of Remaining Battery Charge54
Figure 42: Help Overlay55
Scanner Toolbar56
Figure 43: Scanner Toolbar56
Figure 44: Percentage of Remaining Battery Charge57
Figure 45: Help Overlay58
Touch-Screen Gestures59
Defining the Scanner Settings59
Figure 46: Settings Window60
Defining the Computer Settings61
Figure 47: Brightness Settings61
Figure 48: Volume Settings61
Figure 49: List of Nearby Wi-Fi Networks62
Figure 50: Connecting to the Clinic Wi-Fi Network63
Figure 51: Forgetting or Disconnecting from the Network63
Figure 52: Time Zone Settings64
Defining the User Settings65
Figure 53: Scan Settings Window65
Figure 54: Only Scanning Range Is Highlighted67
Figure 55: Rx Settings Window68
Figure 56: Rx Settings Window - NIRI Captures Option Enabled70
Figure 57: Disable NIRI Confirmation70
Figure 58: Rx Settings Window - NIRI Captures Option Disabled71
Figure 59: Signature Settings Window72
Defining the System Settings73
Figure 60: Language Settings Window73
Figure 61: Login Settings Window74
Figure 62: Diagnostics Window75
Figure 63: Licensing Information Window76
Figure 64: System Information Window77
Figure 65: Export Settings Window - Deleting Exported Files78
Starting a New Scan79
Applying a Wand Barrier Sleeve79
Figure 66: Remove the Protective Sleeve79
Figure 67: Remove the Wand Barrier Sleeve from Its Packaging80
Figure 68: Slide the Rigid Section of the Wand Barrier Sleeve into Place80
Starting the Scan81
Figure 69: Gently Pull the Transparent Sheath to Cover the Entire Wand81
Figure 70: New Scan Window Showing an Empty Rx and the Progress Toolbar at the Top of the Window82
Patient Management83
Adding New Patients84
Figure 71: New Scan Window - Adding a New Patient84
Figure 72: New Patient Window85
Figure 73: Adding the New Patient86
Figure 74: Message Notifying that a Patient with the same Details Exists86
Searching for Existing Patients87
Figure 75: Confirmation Message Regarding an Existing Patient87
Figure 76: New Scan Window - Searching for an Existing Patient88
Figure 77: Search Patient Window with Search Field89
Figure 78: Search Criteria in the Search Field and List of Matching Patients90
Figure 79: Selecting the Required Patient90
Editing the Patient Details91
Figure 80: Selected Patient Displayed in the New Scan Window91
Figure 81: New Scan Window - Editing a Patient92
Figure 82: Edit Patient Window and Update Button92
Clearing the Patient Details from the New Scan Window93
Figure 83: Message that a Patient with the same Details Already Exists93
Filling in the Rx94
Figure 84: Clear Patient Data Button94
Figure 85: Selecting the Required Case Type95
Figure 86: New Scan Window - Irecord Case Type96
Working with Restorative Scan Types97
Figure 87: New Sleeve Attached Check Box97
Figure 88: New Scan Window - Restorative Case Type with a Tooth Chart98
Figure 89: List of Restorative Treatment Options99
Figure 90: Defining the Restoration Properties100
Figure 91: Treatment Information Area101
Disabling NIRI Capture102
Figure 92: Disabling NIRI Capture for a Specific Case102
Figure 93: Scan Tool Without the Option to Display NIRI Data in the Viewfinder or to Enlarge the Viewfinder103
Figure 94: Review Tool Is Not Displayed in View Mode103
Confirming a New Wand Barrier Sleeve between Patients104
Figure 95: Check Box Confirming a New Wand Barrier Sleeve104
Scanning the Patient105
Figure 96: Popup Confirmation Message before Scanning105
Scanning Guidance106
Figure 97: Recommended Scanning Sequence - Lower Jaw106
Scanning Best Practices107
Figure 98: Wand Guidance107
Scan Options108
Figure 99: Areas with Missing Anatomy Shown with and Without Additional Scan Feedback - Monochrome108
Figure 100: Areas with Missing Anatomy Shown with and Without Additional Scan Feedback - Color Mode109
Figure 101: Model Displayed in Color and Monochrome Mode109
Toggling the 3D and Viewfinder Display110
Figure 102: Tap the Opposite Arch or Tap the Arrows to Select It110
Figure 103: Default View - 3D Scan in the Center of the Window and Viewfinder on the Left111
Figure 104: Large Viewfinder in the Center of the Screen and 3D Image on the Left111
Toggling between Color and NIRI Images in the Viewfinder112
Editing a Scan112
Figure 105: Viewfinder Displaying a Color Image (Left) or a NIRI Image (Right)112
Viewing the Scan113
Figure 106: Editing Tools113
Missing Scan Segment Notifications114
Figure 107: Missing Scan Message and Missing Segments Highlighted in Red114
Using the Scan Timer115
Sending the Scan115
Figure 108: Scan Timer Button on the Toolbar and Scan Time115
Working with the Viewer116
Figure 109: Sending the Scan116
Figure 110: Viewer Option in the Past Orders Pane in the Orders Page116
Figure 111: Viewer Option in Patient's Profile Page117
Figure 112: Model in a 1-Window View118
Figure 113: Model in a 2-Window View118
Figure 114: Model in a 5-Window View119
Removing the Wand Barrier Sleeve120
Figure 115: Scrunch the Transparent Sheath Halfway Towards the Tip120
Figure 116: Slightly Release the Rigid Section of the Wand Barrier Sleeve from the Tip of the Wand120
Figure 117: Remove the Wand Barrier Sleeve121
Figure 118: Optical Surface of the Wand121
Working with Patients123
Figure 119: Patients Page123
Searching for Patients124
Figure 120: Searching for a Patient124
Figure 121: Patients Matching the Search Criteria Are Displayed124
Viewing the Patient Details125
Creating a New Scan for a Specific Patient125
Figure 122: Patient's Profile Page125
Figure 123: Patient's Profile Page - New Scan Option126
Figure 124: New Scan Window with Patient's Details Already Filled in126
Viewing the Rx127
Figure 125: Patient's Profile Page - View Rx Option127
Viewing Previous Scans in the Viewer128
Figure 126: Rx Details Window128
Figure 127: Patient's Profile Page - Viewer Option129
Figure 128: Scan Displayed in the Viewer129
Working with Orders131
Figure 129: Orders Page132
Figure 130: in Progress Pane - Options133
Figure 131: Past Orders Pane - Options133
Viewing Messages135
Figure 132: Messages Page135
Working with Myitero137
Itero Scanner Features and Tools139
Comparing Previous Scans Using Itero Timelapse Technology139
Figure 133: Itero Timelapse - Selecting the Scans to Compare140
Figure 134: Itero Timelapse Window Showing the Highlighted Changes between the Scans140
Figure 135: Area of Interest from the First Scan Displayed in the Animation Window141
Figure 136: Area of Interest from the Second Scan Displayed in the Animation Window141
Invisalign Go System142
Figure 137: Itero Timelapse Scale Options142
Invisalign Outcome Simulator143
Invisalign Progress Assessment143
Figure 138: Progress Assessment Window143
Editing Tools144
Deleting a Segment144
Figure 139: Editing Tools144
Deleting a Selection145
Figure 140: Delete Segment Tool145
Figure 141: Delete Selection Tool146
Figure 142: Expanded Delete Selection Tool146
Filling in Missing Anatomy147
Figure 143: Selected Area of the Anatomy Is Deleted147
Figure 144: Fill Tool148
Figure 145: Areas that Require Scanning Are Highlighted in Red - Fill Tool148
Disabling A.I. Cleanup149
Figure 146: Disable A.I. Cleanup Tool149
Working with the Eraser Tool150
Figure 147: Scan Displayed with Excess Material Showing150
Figure 148: Eraser Tool151
Figure 149: Eraser Tool Options151
Figure 150: Mark the Area to be Modified152
Figure 151: Selected Area Removed and Scan Tool Enabled152
Working with the Occlusal Clearance Tool153
Figure 152: Deleted Area Marked in Red153
Figure 153: Occlusal Clearance between the Opposing Teeth154
Figure 154: Occlusal Clearance Range Options155
Working with the Edge Trimming Tool156
Figure 155: Occlusal Clearance Tool and Legend Displayed in the Viewer156
Figure 156: Edge Trimming Tool157
Figure 157: Edge Trimming Tool Options157
Figure 158: Mark the Area to be Trimmed Away158
Figure 159: Selected Area Is Highlighted and the Confirmation Icon Is Enabled158
Working with the die Separation Tool159
Figure 160: Selected Area Has Been Removed159
Figure 161: Green Hint Point Centered on the Prepped Tooth160
Figure 162: die Separation Is Displayed in High Resolution160
Figure 163: die Separation Tool Options161
Figure 164: Scan Is Displayed in Low Resolution161
Figure 165: before Selecting the die Separation162
9.10 Working with the Review Tool163
Figure 166: Prepped Tooth Is Displayed in High Resolution163
Figure 167: Review Tool with the Snapshot Tool on the Toolbar and the Loupe in the Right Pane164
9.10.1 Zooming in to and out of the Images in the Image Pane165
Figure 168: Image Pane on the Right Showing the Area of Interest as both NIRI and Colored Intraoral Images165
Figure 169: Zoom-In Buttons on the Images in the Image Pane166
Figure 170: Only the Zoomed-In Image Is Displayed in the Enlarged Image Pane Window166
9.10.2 Adjusting the Brightness and Contrast of Images in the Image Pane167
Figure 171: Brightness and Contrast Toolbar Is Collapsed167
9.10.3 Capturing the Review Tool Images168
9.11 Working with the Snapshot Tool168
Figure 172: Brightness and Contrast Toolbars168
Figure 173: View Mode - with Snapshot Tool169
Figure 174: Screen Capture Thumbnail Is Displayed after Taking a Screen Capture170
Figure 175: Screenshot with an Annotations Toolbar170
Figure 176: Annotations Toolbar171
Figure 177: Adding Text to the Screenshot171
Figure 178: Screenshot with Annotations172
Figure 179: Notification that the Screenshots and Annotations will be Uploaded to Myitero172
Figure 180: Confirmation about the Annotations Being Discarded173
Figure 181: Notification that the Screenshots will be Uploaded to Myitero173
Figure 182: Option to Download Screenshots from the Orders Page in Myitero174
10 Care and Maintenance175
10.1 Handling the Wand and Cable175
10.2 Cleaning and Disinfecting the Wand175
10.2.1 Preparation before Cleaning and Disinfection175
10.2.2 Wand Cleaning and Disinfection176
Figure 183: Wand Without a Wand Barrier Sleeve176
Figure 184: Remove Gross Contaminants Using Caviwipes1177
Figure 185: Remove Marks and Stains Using a Soft Bristle Brush177
10.2.3 Drying - Wand Body178
10.2.4 Storage and Maintenance178
Figure 186: Wipe the Optical Surface of the Wand with IPA178
Figure 187: Release and Remove the Vent Cover179
Figure 188: Insert the Tip of the Wand into the New Vent Cover179
Figure 189: Pull on the Vent Cover until It Locks into Place179
10.3 Cleaning and Disinfecting the Cradle180
10.3.1 Preparation before Cleaning and Disinfection180
Figure 190: Check that the Rear End of the Vent Cover Reaches the Cable Cap180
10.3.2 Cradle Cleaning and Disinfection181
Figure 191: Remove Gross Contaminants on the Cradle Using Caviwipes1181
Figure 192: Remove Remaining Marks and Stains on the Cradle Using the Soft Bristle Brush181
10.3.3 Drying - Cradle182
10.3.4 Storage and Maintenance182
10.4 Cleaning and Disinfecting the Scanner Touch Screen and the Wheel-Stand Handle182
10.5 General Cleaning182
10.6 Approved Cleaning and Disinfecting Materials182
A Clinic LAN Network Guidelines185
Introduction185
Preparations185
Router Guidelines186
Internet Connection Guidelines186
Firewall186
Wi-Fi Tips186
Align Hostname Recommendations187
BEMC Declaration189
CFCC Compliance Information Statement (Sdoc)193
D Itero Element Product Security Whitepaper195
E System Specifications199

iTero Element 5D Plus - CFCC Compliance Information Statement (Sdoc)

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