Align Technology iTero Element 5D

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Align Technology, Inc.

410 North Scottsdale Road,

Suite 1300, Tempe,

Arizona 85281

USA

are trademarks and/or service marks of Align Technology, Inc., or one of its subsidiaries or

affiliated companies and may be registered in the U.S. and/or other countries. 215411 Rev. A

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Table of Contents17
Introduction to Itero Element 5D and Itero Element 5D Plus Imaging Systems29
Intended Purpose/Intended Use30
Indications for Use30
Contraindications30
Intended Patient Population30
Intended Users30
Use Environment30
Clinical Benefits31
Itero Element 5D and Itero Element 5D Plus Hardware31
Itero Element 5D Wheel-Stand Configuration32
Figure 1: Front View of the Itero Element 5D Imaging System32
Itero Element 5D Laptop Configuration33
Figure 2: Rear View of the Itero Element 5Dimaging System33
Figure 3: Itero Element 5D Laptop Configuration Imaging System33
Itero Element 5D Plus Cart Configuration34
Figure 4: Front View of the Itero Element 5D Plus Cart-Configuration Imaging System34
Itero Element 5D Plus Mobile Configuration35
Figure 5: Rear View of the Itero Element 5D Plus Cart-Configuration Imaging System35
Figure 6: Front View of the Itero Element 5D Plus Mobile-Configuration Imaging System35
Itero Element 5D Wand36
Figure 7: Rear View of the Itero Element 5D Plus Mobile-Configuration Imaging System36
Figure 8: Itero Element 5D Wand36
Itero Element 5D, Itero Element 5D Plus, and 5D Plus Lite Software37
Figure 9: Protective Sleeve37
Figure 10: Disposable Sleeve37
1.10 Working with Itero Near Infra-Red Imaging (NIRI) Technology38
Figure 11: Visible Light Spectrum Showing NIRI on the 850Nm Wavelength38
Figure 12: Reflective Concept - Healthy Enamel Is Translucent While Dentin and Caries Are Reflective38
Figure 13: Interproximal Carious Lesion39
1.10.1 Itero NIRI Technology Limitations40
1.11 about this Manual40
Assembly Instructions41
Assembling the Itero Element 5D Wheel-Stand Configuration Scanner42
Assembling the Itero Element 5D Laptop Configuration Scanner46
Installing the Itero Element 5D Software - Laptop Configuration46
Assembling the Itero Element 5D Plus and 5D Plus Lite Scanner - Cart Configuration48
Figure 14: Removing the Wand from the Cradle51
Figure 15: Moving the Scanner52
Figure 16: Do Not Lift the Scanner Using the Main Handle52
Assembling the Itero Element 5D Plus and 5D Plus Lite Scanner - Mobile Configuration53
Initial Assembly54
Moving the Scanner Within the Clinic56
Using the Trolley for Transportation56
Optional Protective Cover58
VESA Mounting58
Figure 17: Do Not Allow the Power Pack to Dangle in the Air60
Figure 18: Never Tilt the Screen more than 45 Degrees60
Getting Started61
Logging in to the Scanner for the First Time61
Registering the Scanner - Make It Mine Process61
Figure 19: Welcome Screen61
Figure 20: Connect Page Listing the Available Networks62
Figure 21: Entering the Security Key63
Figure 22: Scanner Is Connected to the Internet and Online63
Figure 23: Verifying the Communication with Align64
Figure 24: Selecting the Time Zone64
Figure 25: Registering the System to Customize the Setup65
Figure 26: Itero Subscription Package65
Figure 27: License Agreement66
Figure 28: Checking for Updates66
Working in Demo Mode67
Figure 29: System Is Registered and Ready67
Figure 30: Itero Element Logo68
Figure 31: Demo Mode Option68
Figure 32: Login Window with a List of Demo Users69
Figure 33: Demo Login Button69
Figure 34: Demo Mode Home Screen70
Figure 35: Past Orders Pane - Options71
Exiting Demo Mode72
Figure 36: Exiting Demo Mode72
Working with the Scanner73
Logging in to the Scanner73
Figure 37: Login Window73
Figure 38: Unexpected Shutdown Notification74
Figure 39: Password Is Masked75
Figure 40: Itero Home Screen76
Resetting Your Password77
Figure 41: Forgot Password Button77
Figure 42: Email Field for Forgotten Password77
Figure 43: Security Answer Field78
Installing Windows Security Updates79
Figure 44: Login Window with Notification about Windows Security Updates79
Logging out of the Scanner80
Figure 45: Home Screen with Notification about Windows Security Updates80
Shutting down the Scanner81
Moving the Scanner81
Moving the Itero Element 5D Wheel-Stand Configuration Scanner81
Transporting the Itero Element 5D Laptop Configuration Imaging System81
Moving the Itero Element 5D Plus Cart-Configuration Scanner82
Figure 46: Itero Element 5D Laptop Configuration Imaging System in the Supplied Carrying Case82
Carrying the Itero Element 5D Plus Mobile-Configuration Scanner Within the Clinic83
Figure 47: Moving the Scanner83
Transporting the Itero Element 5D Plus Mobile-Configuration Scanner between Clinics84
Figure 48: Carrying the Scanner between Rooms Within the Clinic84
Figure 49: Transporting the Scanner between Clinics84
User Interface85
Figure 50: Itero Home Screen85
Figure 51: Percentage of Remaining Battery Charge86
Figure 52: Help Overlay86
Scanner Toolbar88
Figure 53: Scanner Toolbar88
Figure 54: Percentage of Remaining Battery Charge89
Figure 55: Help Overlay89
Touch-Screen Gestures90
Defining the Scanner Settings91
Figure 56: Settings Window91
Defining the Computer Settings92
Figure 57: Brightness Settings92
Figure 58: Volume Settings92
Figure 59: List of Nearby Wi-Fi Networks93
Figure 60: Connecting to the Clinic Wi-Fi Network94
Figure 61: Forgetting or Disconnecting from the Network94
Figure 62: Time Zone Settings95
Defining the User Settings96
Figure 63: Scan Settings Window96
Figure 64: Only Scanning Range Is Highlighted98
Figure 65: Rx Settings Window99
Figure 66: Rx Settings Window - NIRI Captures Option Enabled101
Figure 67: Disable NIRI Confirmation101
Figure 68: Rx Settings Window - NIRI Captures Option Disabled102
Figure 69: Signature Settings Window103
Defining the System Settings104
Figure 70: Language Settings Window104
Figure 71: Login Settings Window105
Figure 72: Diagnostics Window106
Figure 73: Licensing Information Window107
Figure 74: System Information Window - Itero Element 5D Plus108
Figure 75: Export Settings Window - Deleting Exported Files109
Starting a New Scan110
Applying a Wand Sleeve110
Starting the Scan110
Figure 76: Gently Slide the New Sleeve into Place110
Figure 77: New Scan Window Showing an Empty Rx and the Progress Toolbar at the Top of the Window111
Figure 78: New Scan Window - Itero Element 5D Plus Lite111
Patient Management112
Adding New Patients113
Figure 79: New Scan Window - Adding a New Patient113
Figure 80: New Patient Window114
Figure 81: Adding the New Patient115
Figure 82: Message Notifying that a Patient with the same Details Exists115
Searching for Existing Patients116
Figure 83: Confirmation Message Regarding an Existing Patient116
Figure 84: New Scan Window - Searching for an Existing Patient117
Figure 85: Search Patient Window with Search Field118
Figure 86: Search Criteria in the Search Field and List of Matching Patients119
Figure 87: Selecting the Required Patient119
Editing the Patient Details120
Figure 88: Selected Patient Displayed in the New Scan Window120
Figure 89: New Scan Window - Editing a Patient121
Figure 90: Edit Patient Window and Update Button121
Clearing the Patient Details from the New Scan Window122
Figure 91: Message that a Patient with the same Details Already Exists122
Filling in the Rx123
Figure 92: Clear Patient Data Button123
Figure 93: Selecting the Required Case Type124
Figure 94: New Scan Window - Irecord Case Type125
Working with Restorative Scan Types126
Figure 95: New Sleeve Attached Check Box126
Figure 96: New Scan Window - Restorative Case Type with a Tooth Chart127
Figure 97: List of Restorative Treatment Options128
Figure 98: Defining the Restoration Properties129
Figure 99: Treatment Information Area130
Disabling NIRI Capture131
Figure 100: Disabling NIRI Capture for a Specific Case131
Figure 101: Scan Tool Without the Option to Display NIRI Data in the Viewfinder or to Enlarge the Viewfinder132
Figure 102: Review Tool Is Not Displayed in View Mode132
Confirming a New Wand Sleeve between Patients133
Figure 103: Check Box Confirming a New Sleeve133
Scanning the Patient134
Figure 104: Popup Confirmation Message before Scanning134
Scanning Guidance135
Figure 105: Recommended Scanning Sequence - Lower Jaw135
Scanning Best Practices136
Scan Options136
Figure 106: Wand Guidance136
Figure 107: Areas with Missing Anatomy Shown with and Without Additional Scan Feedback - Monochrome137
Figure 108: Areas with Missing Anatomy Shown with and Without Additional Scan Feedback - Color Mode137
Figure 109: Model Displayed in Color and Monochrome Mode138
Toggling the 3D and Viewfinder Display139
Figure 110: Tap the Opposite Arch or Tap the Arrows to Select It139
Figure 111: Default View - 3D Scan in the Center of the Window and Viewfinder on the Left140
Figure 112: Large Viewfinder in the Center of the Screen and 3D Image on the Left140
Toggling between Color and NIRI Images in the Viewfinder141
Editing a Scan141
Figure 113: Viewfinder Displaying a Color Image (Left) or a NIRI Image (Right)141
Viewing the Scan142
Figure 114: Editing Tools142
Missing Scan Segment Notifications143
Figure 115: Missing Scan Message and Missing Segments Highlighted in Red143
Using the Scan Timer144
Sending the Scan144
Figure 116: Scan Timer Button on the Toolbar and Scan Time144
Working with the Viewer145
Figure 117: Sending the Scan145
Figure 118: Viewer Option in the Past Orders Pane in the Orders Page145
Figure 119: Viewer Option in Patient's Profile Page146
Figure 120: Model in a 1-Window View147
Figure 121: Model in a 2-Window View148
Figure 122: Model in a 5-Window View148
Removing the Wand Sleeve149
Figure 123: Removing a Wand Sleeve149
Figure 124: Optical Surface of the Wand150
Figure 125: Gently Slide the New Sleeve into Place150
Working with Patients151
Searching for Patients151
Figure 126: Patients Page151
Figure 127: Searching for a Patient152
Figure 128: Patients Matching the Search Criteria Are Displayed152
Viewing the Patient Details153
Figure 129: Patient's Profile Page153
Creating a New Scan for a Specific Patient154
Figure 130: Patient's Profile Page - New Scan Option154
Figure 131: New Scan Window with Patient's Details Already Filled in155
Viewing the Rx156
Figure 132: Patient's Profile Page - View Rx Option156
Viewing Previous Scans in the Viewer157
Figure 133: Rx Details Window157
Figure 134: Patient's Profile Page - Viewer Option158
Figure 135: Scan Displayed in the Viewer158
Working with Orders159
Figure 136: Orders Page160
Figure 137: in Progress Pane - Options161
Figure 138: Past Orders Pane - Options161
Working with Returned Orders162
Figure 139: Orders Button Notifying a Returned Order162
Figure 140: Returned Order in the in Progress Pane163
Viewing Messages164
Figure 141: Messages Page164
Working with Myitero165
10 Itero Scanner Features and Tools166
10.1 Comparing Previous Scans Using Itero Timelapse Technology166
Figure 142: Itero Timelapse - Selecting the Scans to Compare167
Figure 143: Itero Timelapse Window Showing the Highlighted Changes between the Scans167
Figure 144: Area of Interest from the First Scan Displayed in the Animation Window168
Figure 145: Area of Interest from the Second Scan Displayed in the Animation Window169
10.2 Invisalign Go System170
10.3 Invisalign Outcome Simulator170
Figure 146: Itero Timelapse Scale Options170
10.4 Invisalign Progress Assessment171
Figure 147: Progress Assessment Window171
10.5 Editing Tools172
10.5.1 Deleting a Segment172
Figure 148: Editing Tools172
Figure 149: Delete Segment Tool173
10.5.2 Deleting a Selection174
Figure 150: Delete Selection Tool174
Figure 151: Expanded Delete Selection Tool175
Figure 152: Selected Area of the Anatomy Is Deleted175
10.5.3 Filling in Missing Anatomy176
Figure 153: Fill Tool176
10.5.4 Disabling A.I. Cleanup177
Figure 154: Areas that Require Scanning Are Highlighted in Red - Fill Tool177
Figure 155: Disable A.I. Cleanup Tool178
Figure 156: Scan Displayed with Excess Material Showing178
10.6 Working with the Eraser Tool179
Figure 157: Eraser Tool179
Figure 158: Eraser Tool Options179
Figure 159: Mark the Area to be Modified180
Figure 160: Selected Area Removed, and Scan Tool Enabled180
10.7 Working with the Occlusal Clearance Tool181
Figure 161: Deleted Area Marked in Red181
Figure 162: Occlusal Clearance between the Opposing Teeth182
Figure 163: Occlusal Clearance Range Options183
Figure 164: Occlusal Clearance Tool and Legend Displayed in the Viewer184
10.8 Working with the Edge Trimming Tool185
Figure 165: Edge Trimming Tool185
Figure 166: Edge Trimming Tool Options185
Figure 167: Mark the Area to be Trimmed Away186
Figure 168: Selected Area Is Highlighted, and the Confirmation Icon Is Enabled186
10.9 Working with the die Separation Tool187
Figure 169: Selected Area Has Been Removed187
Figure 170: Green Hint Point Centered on the Prepped Tooth188
Figure 171: die Separation Is Displayed in High Resolution188
Figure 172: die Separation Tool Options189
Figure 173: Scan Is Displayed in Low Resolution189
Figure 174: before Selecting the die Separation190
10.10 Working with the Margin Line Tool191
Automatically Defining the Margin Line191
Figure 175: Prepped Tooth Is Displayed in High Resolution191
Figure 176: Model Display Moves to the Occlusal View, and Zooms in on the Prepped Tooth192
Figure 177: Margin Line Tool Options192
Manually Defining the Margin Line193
Figure 178: Margin Line Is Marked on the Prepped Tooth193
Working with the Review Tool (Itero Element 5D and 5D Plus)194
Figure 179: Margin Line Tool Options194
Figure 180: Review Tool with the Snapshot Tool on the Toolbar and the Loupe in the Right Pane195
Zooming in to and out of the Images in the Image Pane196
Figure 181: Image Pane on the Right Showing the Area of Interest as both NIRI and Colored Intraoral Images196
Figure 182: Zoom-In Buttons on the Images in the Image Pane197
Figure 183: Only the Zoomed-In Image Is Displayed in the Enlarged Image Pane Window197
Adjusting the Brightness and Contrast of Images in the Image Pane198
Figure 184: Brightness and Contrast Toolbar Is Collapsed198
Capturing the Review Tool Images199
Working with the Review Tool (Itero Element 5D Plus Lite)199
Figure 185: Brightness and Contrast Toolbars199
Figure 186: Review Tool with the Snapshot Tool on the Toolbar and the Loupe in the Right Pane200
Zooming in to and out of the Images in the Image Pane201
Figure 187: Image Pane on the Right Showing the Area of Interest201
Figure 188: Zoom-In Button on the Image in the Image Pane202
Figure 189: Zoomed-In Image Displayed in the Enlarged Image Pane202
Adjusting the Brightness and Contrast of Images in the Image Pane203
Figure 190: Brightness and Contrast Toolbar Is Collapsed203
Capturing the Review Tool Images204
Figure 191: Brightness and Contrast Toolbar204
10.13 Working with the Snapshot Tool205
Figure 192: View Mode - with Snapshot Tool206
Figure 193: Screen Capture Thumbnail Is Displayed after Taking a Screen Capture206
Figure 194: Screenshot with an Annotations Toolbar207
Figure 195: Annotations Toolbar207
Figure 196: Adding Text to the Screenshot208
Figure 197: Screenshot with Annotations208
Figure 198: Notification that the Screenshots and Annotations will be Uploaded to Myitero209
Figure 199: Confirmation about the Annotations Being Discarded209
Figure 200: Notification that the Screenshots will be Uploaded to Myitero210
Figure 201: Option to Download Screenshots from the Orders Page in Myitero210
11 Care and Maintenance211
11.1 Handling the Wand and Cable211
11.2 Cleaning and Disinfecting the Wand211
11.2.1 Preparation before Cleaning and Disinfection212
Figure 202: Wand Without a Sleeve212
11.2.2 Wand Cleaning and Disinfection213
Figure 203: Remove Gross Contaminants Using Caviwipes1213
Figure 204: Remove Marks and Stains Using a Soft Bristle Brush213
11.2.3 Drying - Wand Body214
11.2.4 Storage and Maintenance214
Figure 205: Wipe the Optical Surface of the Wand with IPA214
11.3 Cleaning and Disinfecting the Cradle215
11.3.1 Preparation before Cleaning and Disinfection215
11.3.2 Cradle Cleaning and Disinfection216
Figure 206: Itero Element 5D - Remove Gross Contaminants on the Cradle Using Caviwipes1216
Figure 207: Itero Element 5D Plus Cart - Remove Gross Contaminants on the Cradle Using Caviwipes1216
11.3.3 Drying - Cradle218
11.3.4 Storage and Maintenance219
11.4 Cleaning and Disinfecting the Scanner Touch Screen and the Wheel-Stand Handle219
11.5 General Cleaning219
11.6 Approved Cleaning and Disinfecting Materials220
A Clinic LAN Network Guidelines221
Introduction221
Preparations221
Router Guidelines222
Internet Connection Guidelines222
Firewall222
Wi-Fi Tips222
Align Hostname Recommendations223
BEMC Declarations224
EMC Declaration - Itero Element 5D224
EMC Declaration - Itero Element 5D Plus227
C Itero Element Product Security Whitepaper230
D System Specifications233
Itero Element 5D Wheel-Stand Configuration System Specifications234
Itero Element 5D Laptop Configuration System Specifications235
Itero Element 5D Plus System Specifications236

Align Technology iTero Element 5D - Page 246

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