UBM Plus Users Guide Rev C

Contents

Federal law restricts this device to sale by or on the order of a physician. FEDERAL COMMUNICATIONS COMMISSION (FCC) UNINTENTIONAL EMITTER PER FCC PART 15 This device has been tested and found to comply with the limits for a Class B digital device, pursuant to Part 15 of the FCC rules. These limits are designed to provide reasonable protection against harmful interference in an office installation. This equipment generates, uses, and can radiate radio frequency energy and, if not installed and used in accordance with the instructions in the user manual, may cause harmful interference to radio or television reception. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause interference to radio and television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures: • Reorient or relocate the receiving antenna • Increase the separation between the equipment and receiver • Connect the equipment to an outlet on a different circuit from that to which the receiver is connected • Consult Accutome Ultrasound, Inc or an experienced radio/TV technician for help. This device complies with Part 15 of the FCC Rules. Operation of this product 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. CAUTION: Changes or modifications not expressly approved by Accutome Ultrasound, Inc. could void the FCC compliance and negate your authority to operate the product. Authorized Representative in Europe (for regulatory affairs only):

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Accutome

UBM Plus User Guide

CONTENTS INTRODUCTION1 Features2 Adjustable TGC Curves 2 Gamma Settings 2 Gain Adjustment 2 Automatic Image Orientation Labeling 2 Image Playback 2 Measurements3 Patient Data Storage and Retrieval 3 Reports and Printouts 3 Components3 About this Manual 4 Safety Information 7 Safety Issues to Consider When Using the Accutome UBM Plus 7 Indications for Use 7

SAFETY7 Symbol Definitions for the Accutome UBM Plus Disposal Requirements Disposal of the Product within the EU Safety Precautions and Disinfection Cleaning and Disinfection Cleaning and Disinfection of Sclera Shells Cleaning of Probe Disinfection of Probe Electrical Hazard and Safety Avoiding Equipment Damage Assembling the Accutome UBM Plus What you need

GETTING STARTED

8 8 8 8 9 9 9 10 11 11 14 14

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PC15 Table UBM Computer Specifications 15 Probe15 Anterior Segment Imaging Scleral Shell 15 II

Contents Printer15 Footswitch16 Installation - Phase One: 16 Installation - Phase Two: 21 Quick Start User Guide for Accutome UBM Plus 22 Install Example Exams – OPTIONAL 24 Installation - Phase One: 25 Installation - Phase Two: 26 QUICK START USER GUIDE FOR ACCUTOME UBM PLUS 27 Install Example Exams – OPTIONAL 29 Installation - Phase Two: 35 QUICK START USER GUIDE FOR ACCUTOME UBM PLUS 37 Install Example Exams – OPTIONAL 39 Accutome UBM Plus Installation Instructions For Windows 7 & Vista 32-bit 40 Installation - Phase One: 40 Installation - Phase Two: 45 Probe47 Footswitch Setup 48 Basic Operation 49 Starting Accutome UBM Plus Program 49 How to Start a new Patient exam: 50 Entering Patient Exam Information 51 Selecting an Existing Patient for Exam 58 Operation59 Scanning62 How to Print an Exam 62 How to Save Patient Exams 63 Insertion of the Anterior Segment Imaging Scleral Shell 63 Setting Up the UBM Plus 66 How to Access Setup 66

SETUP66 Setup Menu Selections 67 Facilities68 How to Add New Facilities 68 Deleting Facilities 70 Duplicate Facilities from Selected 71 III

Accutome

UBM Plus User Guide

Set Selected Facility as Default 71 Save71 Restore72 Users73 How to Add a New User 73 Deleting Users 75 Set Selected User as Default 76 Save76 Restore76 Sequences 77 How to Create Sequences 77 How to Add New Sequences 78 How to Define the Sequence Scan 81 Edit Current View Selections 82 How to Add Another Sequence Scan 84 Deleting Sequences 89 Duplicate Sequences from Selected 90 Set Selected Sequence as Default 90 Save91 Restore91 Options92 Folders of Exams 93 Main Folder 93 Restored Folder 95 Exam Name Combination 97 Probe Control 98 Frequency 98 Depth99 Cine Buffer 100 Start/Stop101 Power101 System Defaults 102 Info On Images 102 Info to Show 102 Measurement Data Position 102 File and Print 103 Show Name on Snapshot Filename 103 IV

Contents Print Format 103 Image Controls 104 TGC105 Gamma Settings 106 Preset Gamma 106 Contrast107 Brightness107 Gain108 Adjusting the Gain 108 Image Controls System Defaults 110 Reset All to Defaults 111 Save111 Restore112 Exiting Setup 112 Physicians113 How to Add a New Physician 113 Deleting Physicians 115 Set Selected Physician as Default 116 Save116 Restore116 Users117 How to Add a New Users 117 Deleting Users 119 Set Selected User as Default 120 Save120 Restore120 Overview122 Exam Steps 122

PERFORMING EXAMS

How to Start a New Exam No Probe Found Initial Exam Screen Entering Information on Initial Exam Screen Entering Data Moving Between Fields Selecting Items from a Drop Down List Patient Info V

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Accutome

UBM Plus User Guide

Required Fields 126 First Name 126 Last Name 126 Medical Record Number 126 Date of Birth 126 Gender128 Indication of Scan 128 Probe Info 129 Frequency 129 Default Range 129 Gain129 Sweep Angle 129 Serial Number 129 Exam Info 130 Exam ID 130 Facility130 Physician131 Operator132 Exam Setup 133 Create Date/Time 133 Scan Group 133 Protocol134 Description134 Import From Existing Exam 134 Start Exam 135 Use of the Anterior Segment Imaging Scleral Shell 136 Exam Screen Features 138 Exam Information Displayed above Image 139 Current View 139 All Views 139 Tools Palette 139 Probe Tab 140 TGC Adjustments 141 Gamma Adjustments 141 Cine142 Tool Tab 143 Add View 144 VI

Contents Edit Current View 144 Current View 144 Axial144 Longitudinal145 Transverse145 Edit Exam Info 145 Analyze146 Menu Buttons 146 Main Menu 146 Exit146 Probe Usage in Scanning 147 How the UBM Works 147 Probe Operation 148 Marker Alignment 149 Probe Positions 150 Axial Probe Positions 150 Longitudinal Probe Positions 150 Transverse Probe Positions 150 How to Scan 152 Using the Footswitch 152 Scanning with a Predefined Protocol 152 Scanning without a Protocol 153 Proceed with the Next Scan 155 Adding a View 156 Adjusting the Gain 157 Changing the Scan View 158 A-Vector162 Completing Patient Exam 164 Main Menu 164 New Exam 164 Exit164 Analyze164 Overview166 Selecting Images for Analysis 166 How to Select an Existing Exam 166

PATIENT IMAGE ANALYSIS Analyze Screen

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UBM Plus User Guide

Analyze Screen Features 168 Exam Information Displayed above Image 169 Current View 169 Current View Orbital Locators 169 Editing Current View Info 170 Views to Review 170 Play Controls 170 Zoom Controls 170 TGC Adjustments 170 Gamma Adjustments 170 Edit Exam Info 171 Menu Buttons 171 Selecting an Existing Exam 172 How to Edit Exam Info 174 Drop Down Lists 174 Text Fields 174 Restore175 Cancel176 Done176 Exams177 Playing an Exam 178 Stopping an Exam 179 Pause180 Forward181 Backward182 TGC Adjustment 183 How to Adjust the TGC 183 Image Enhancement Gammas 185 Linear Grey-Scale 186 S-Curve Grey-Scale 187 Log Grey-Scale 188 Color189 Changing Gamma Settings 190 How to Use Zoom 191 Reset Zoom 192 How to Move Image 193 How to Take a Measurement on an Existing Image 194 VIII

Contents Measurement Types 194 Taking Distance Measurements 194 Taking Area Measurements 196 Delete Current 198 Taking Angle Measurement 199 A-Vector203 Comments on Image 205 Overview208 Printing Images 208

PRINTING IMAGES & REPORTS

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ARCHIVE & RESTORE

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How to Print an Image 209 Selecting Patient Exam 209 Selecting a Frame 209 Adjusting Images 210 Executing Print 210 Creating Reports 212 Selecting Patient Exam 212 Capturing Snapshots 213 Reports Tool 214 Snapshot List 215 Deleting Snapshots 216 Executing Manage Reports 217 Create a New Report 218 Report Form 219 Selecting Snapshots 220 Pop Up Windows 221 Inserting Selected Snapshots 222 Alternate Method for Selecting & Inserting Snapshots 222 Print or Save Report 223 Overview224 Archive Screen Archive to CD or DVD Selecting Patient Exams Selecting Individual Exams

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UBM Plus User Guide

Select All 228 Clear All 229 Burn Disc 230 Archive to a Local/Net Hard Disk 231 Selecting Patient Exams 232 Selecting the Backup Tool 232 Selecting the Destination Folder 233 Locating Destination Folder 233 Additional Archive Features 237 Delete Selected Exams 237 Disc Tool Features 238 Save Reports Only 238 Erase Disc 238 Abort Proc. 238 Disc Info 239 Verify Burn 240 Check to Fit the Media 240 Eject Disc 240 Load Disc 241 Local/Net Hard Disk 241 Checking System Free Space 241 Space Required 241 If Name Conflict Found 241 Check Name Conflict 241 Abort Backup 241 Verify242 Restore Screen 242 Restore from DVD or CD 244 Selecting Patient Exams 244 Selecting Individual Exams 245 Select All 248 Clear All 249 Restore250 Restore Local/Network Hard Disk 251 Selecting the Local/Network HD Tool 252 Selecting the Folder for Restoring Exams 254 Selecting Patient Exams 256 X

Contents Executing Restore 257 Additional Restore Features 259 Exams on Backup Features 259 Select All 259 Clear All 260 Total Space Needed 260 Check Conflict 260 Overwrite Old Exams 260 Exams on Destination 261 Select All 261 Clear All 261 Remove Selected Exams 262 Exams on System 263 DVD/CD Features 264 Free Space On The System 264 Select Folder 264 Information of Media 265 Eject265 Load265 Abort266 Available Exams 266 Local/Net Hard Disk 266 Select Folder 266 List Exams in the Folder 266 Abort266 Main Menu and Exit 266 General Maintenance 269

Maintenance269 Overview270 Physical Specifications 270 Table 2 Accutome UBM Plus Physical Specifications 270

Specifications

Table 3 Accutome UBM Plus Physical Specifications Environmental Specifications Table 4 Environmental Specifications Computer Specifications Table 5 Recommended Computer Specifications XI

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UBM Plus User Guide

Operating Modes 274 Table 6 Operating Mode(s) 274 Table 7 Operating Mode(s) 275 Table 8 Range and Accuracy 275 Acoustic Output 276 Table 9 Acoustic Output Reporting Table for Track 1 276 Autoscanning Mode 276 Warranty278

Warranty & Repairs

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Product Returns 279 Service and Repair 279 All Other Returns 279 Non-Returnable Merchandise 279 Replacement Parts 280 Documentation280

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Contents

LIST OF FIGURES List of Figures

Figure 1 Accutome UBM Plus Components 1 Figure 2 Accutome UBM Plus Probe 47 Figure 3 Accutome Anterior Segment Imaging Scleral Shells (18mm and 20mm) 48 Figure 4 Accutome UBM Plus Footswitch 48 Figure 5 Accutome UBM Plus Desktop Shortcut 49 Figure 6 Main Screen Starting New Exam 50 Figure 7 New Exam Info Screen 51 Figure 8 Entering New Patient Information 52 Figure 9 Selecting Facility 53 Figure 10 Selecting Physician 54 Figure 11 Selecting Scan Group and Protocol  55 Figure 12 Starting a New Exam 56 Figure 13 Exam Screen 57 Figure 14 Tool Palette and Current View 59 Figure 15 Probe Tab Active 60 Figure 16 Cine Tab Active 60 Figure 17 TGC Tab Active 61 Figure 18 Gamma Tab Active 61 Figure 19 Selecting Setup 66 Figure 20 Setup Facilities Tab 67 Figure 21 Selecting “New” Facility 68 Figure 22 New Facility Information Active 69 Figure 23 Saving New Facility 70 Figure 24 Update Restore Point Dialog 71 Figure 25 Restore Facilities Dialog 72 Figure 26 Users Screen 73 Figure 27 New User Information Active 74 Figure 28 Saving New User 75 Figure 29 Update Restore Point Dialog 76 Figure 30 Restore Users Dialog 76 Figure 31 Sequences Screen 77 XIII

List of Figures Accutome

UBM Plus User Guide

Figure 32 Adding New Sequence Figure 33 Adding New Sequence Figure 34 Assigning Name to New Sequence Figure 35 New Sequence - New View Active Figure 36 First Scan Editing View Figure 37 Adding a New Sequence Scan Figure 38 New Sequence Scan (View) Added Figure 39 Change Probe Orientation Figure 40 Change Probe Orientation Figure 41 Saving New Sequence Figure 42 Deleting a Sequence Figure 43 Duplicating Current Sequence Figure 44 Update Restore Point Dialog Figure 45 Update Restore Point Dialog Figure 46 Options Screen Figure 47 Selecting Main Exam Folder Figure 48 Windows Browser - Locate Exam Folder Figure 49 Selecting Restored Exam Folder Figure 50 Windows Browser - Locate Exam Folder Figure 51 Selecting Exam Name Combinations Figure 52 Selecting Probe Frequency Figure 53 Selecting Probe Depth Figure 54 Selecting Probe Cine Buffer Figure 55 Adjusting the Power Level Figure 56 Image Settings Before Adjustment Figure 57 TGC Adjustment Figure 58 Selecting a Preset Gamma Figure 59 Adjusting Contrast and Brightness Figure 60 Image Settings after Adjustments Figure 61 Selecting Gain Adjustment Figure 62 Adjusting Gain Figure 63 Restore All Options to System Defaults Figure 64 Update Restore Point Dialog Figure 65 Update Restore Point Dialog Figure 66 Exiting Setup (Cancel) Figure 67 Physicians Screen XIV

78 79 80 81 83 84 85 86 87 88 89 90 91 91 92 93 94 95 96 97 98 99 100 101 104 105 106 107 108 109 110 111 111 112 112 113

Contents Figure 69 Saving New Physician Figure 70 Update Restore Point Dialog Figure 71 Restore Physicians Dialog Figure 72 Users Screen Figure 73 User Name Entered Figure 74 Saving New Users Figure 75 Update Restore Point Dialog Figure 76 Restore Users Dialog Figure 77 Starting a New Exam Figure 78 No Probe Found Message Figure 79 Initial Exam Screen Figure 80 Initial Exam Screen with Patient Name Figure 81 Selecting Gender Figure 82 Selecting Facility Figure 83 Selecting Physician Figure 84 Selecting Operator Figure 85 Selecting Scan Group Figure 86 Selecting Scan Protocol Figure 87 Starting New Exam Figure 88 Exam Screen Layout Figure 89 Probe tab Figure 90 TGC Adjustments Tab Selected Figure 91 Gamma Adjustments Tab Selected Figure 92 Cine Adjustments/Play Tab Selected Figure 93 Tool Tab Figure 94 Edit Exam Information Window Figure 95 Probe Operation Figure 96 Eye and Probe Marker Alignment Figure 97 New Exam with Selected Protocol-First Scan Complete Figure 98 New Exam No Protocol-First Scan Selected Figure 99 New Exam-First Scan Complete Figure 100 New Exam-Second Scan Complete Figure 101 Adding a View Figure 102 Adjusting Gainz Figure 103 Changing a View-Probe Position Figure 104 Changing a View-Slice Position XV

115 116 116 117 118 119 120 120 123 123 124 127 128 130 131 132 133 134 135 138 140 141 142 142 143 145 148 149 153 154 154 155 156 157 158 159

List Accutome of Figures

UBM Plus User Guide

Figure 105 Changing a View-Global Orbit Figure 106 Changing a View-Done Figure 107 Selecting a “Show A-Vector” Figure 108 A-Vector Displayed Figure 109 Starting Existing Exam Figure 110 Analyze Screen Figure 111 Analyze Screen Layout Figure 112 Selecting a Patient Exam Figure 113 Existing Exam Displayed Figure 114 Edit Exam Information Window Figure 115 Restore Exam Information Dialog Figure 116 Cancel Exam Information Dialog Figure 117 Exams Tab Figure 118 Starting Scan Play Figure 119 Scan Stopped and Returned to Beginning Figure 120 Pausing the Scan Film Loop Figure 121 laying the Scan Film Loop Forward Figure 122 Playing the Scan Film Backward Figure 123 TGC Adjustments Displayed Figure 124 Linear Full Range Gamma Setting Figure 125 S-Curve Full Range Gamma Setting Figure 126 Log Full Range Gamma Setting Figure 127 Color Gamma Setting Figure 128 Selecting a New Gamma Setting Figure 129 Zoom Selected Figure 130 Zoom Changed Figure 131 Image Move Icon Figure 132 Line 1 Measurement Selected Figure 133 Line 1 Measurement Displayed Figure 134 Area 1 Measurement Selected Figure 135 Area 1 Measurement Displayed Figure 136 Selecting Angle Tab Figure 137 Positioning the Angle Cursor Figure 68 Physician Name Entered Figure 138 Angle Vertex Figure 139 Example of Iris Angle Figure 140 Selecting “Show A-Vector” XVI

160 161 162 163 166 167 168 172 173 175 175 176 177 178 179 180 181 182 184 186 187 188 189 190 191 192 193 194 196 197 198 199 200 114 201 202 203

Contents Figure 141 A-Vector Displayed Figure 142 Selecting “Comments on Image” Figure 143 Entering Comments Figure 144 Comments Appearing on Image Figure 145 Printing a Frame Figure 146 Selecting Reports Tool Figure 147 Selecting Snapshot List Figure 148 Deleting a Selected Snapshot from List Figure 149 Confirming Snapshot Deletion Figure 150 Executing Manage Reports Figure 151 Creating a New Report Figure 152 Report Form Figure 153 Selecting Snapshots Figure 154 Pop Up Windows Figure 155 Inserting Selected Snapshots Figure 156 Saving a Patient Report Figure 157 Selecting Archive Figure 158 Archive Screen Figure 159 Selecting the First Exam Figure 160 Selecting the Second Exam Figure 161 Select All Figure 162 All Exams Displayed - Clear All Figure 163 Burning the Disc Figure 164 Disc Burning Progress Figure 165 Selecting the Local/Net Hard Disk Tools Figure 166 Launching Select Destination Folder Figure 167 Windows Browser - Locating Destination Folder Figure 168 Destination Folder Displayed Figure 169 Execute Backup Exams Figure 170 Backup Activity Figure 171 Delete Selected Exams Figure 172 Deleting Exam Warning Figure 173 “Disc Info” Figure 174 Verify Burn Results Figure 175 Selecting the Restore Screen Figure 176 Restore Screen Figure 177 Selecting the First Exam XVII

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List of Figures Accutome

UBM Plus User Guide

Figure 178 First Exam Selected Figure 179 Selecting the Second Exam Figure 180 Select All Exams to be Restored Figure 181 Selected Exams To Be Restored - Clear All Figure 182 Restoring the Exam from the CD Figure 183 Exam Restoring Progress Figure 184 Selecting the Local/Net Hard Disk Restore Tools Figure 185 Local/Network HD Restore Tools Active Figure 186 Launching Select Folder (for Restoration) Figure 187 Windows Browser Figure 188 Locating Source Folder Figure 189 Source Folder Displayed Figure 190 Execute Restore Exams on Local/Network HD Figure 191 Restore Activity Figure 192 Exams on Backup Tab Active Figure 193 Overwrite Warning Figure 194 Exams on Destination - Restored Exams Folder Figure 195 Remove Selected Exams Figure 196 Removing Exam from Restored Folder Warning Figure 197 Exams on System - Accutome Exam Data Folder Figure 198 Free Space on System Figure 199 Information of Media

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Contents

LIST OF TABLES Table 1 Table UBM Computer Specifications ...15 Table 2 UBM Plus Physical Specifications ...270 Table 3 UBM Plus Physical Specifications ... 271 Table 4 Environmental Specifications ...272 Table 5 Recommended Computer Specifications ...273 Table 6 Operating Mode(s) ...274 Table 7 Operating Mode(s) ...275 Table 8 Range and Accuracy ...275 Table 9 Acoustic Output Reporting Table for Track 1...276

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