A-Scan Plus Connect Users Guide Rev B

Table of Contents Chapter 1: Introduction...1

Accutome A-Scan Plus Connect Overview ... 1 Features ... 2 Measurements... 2 IOL Calculations ... 3 Components... 3 Optional Components... 3 About this Manual... 4

Chapter 2: Safety...6

Safety Information... 6 Safety Issues to Consider When Using the Accutome A-Scan Plus Connect... 6 Indications for use... 6 Side Effects... 6 Contraindications... 7 Symbol Definitions for the Accutome A-Scan Plus Connect ... 7 Safety Precautions ... 7 Disposal Requirements... 7 Disposal of the product within the EU... 8 Disinfection and Cleaning... 8 How to Prevent Patient-To-Patient Transfer of Infection... 8 Electrical Hazard and Safety ... 9 Avoiding Equipment Damage... 10 Avoiding Electromagnetic and Other Interference ... 11

Chapter 3: Getting Started... 12

Assembling the Accutome A-Scan Plus Connect ... 12 What you Need... 12 Personal Computer Specifications... 13 A-Scan Plus Connect Control Unit... 13 A-Scan Plus Connect 10MHz Composite A-Probe... 13 USB Foot Switch... 13 A-B Type USB Cable (Control Unit to Computer) ... 14 Printer... 14 Accutome A-Scan Plus Connect Software... 14 Assembling the A-Scan Plus Connect... 14 Connecting the Probe ... 15 Probe Setup ... 16 Accutome Ultrasonic Probe Kit (PN 24-4001) ... 17

Accutome Probe with Goldman Tonometer Adapter ... 18 Accutome Probe with Handle Extension ... 19 Connecting the A-Scan Plus Connect to the Computer ... 21 Installation of the Software... 21 Basic Operation... 22 Starting Accutome A-Scan Plus Connect Program ... 22 How to Start a New Patient Exam... 23 Entering Patient Exam Information... 23 Using the Test Block ... 28 Preparing a Patient for Examination ... 29 Measurement Settings... 29 How to Take a Patient Measurement ... 30 How to Perform a Calculation ... 31 How to Print or Save Report ... 35

Chapter 4: How to Navigate the Screens and Buttons... 37

Overview ... 37 Main Tabs... 37 Exams ... 38 Measurement... 39 IOL Calculation... 40 Setup... 41

Chapter 5: Setting Up Personal Preferences...42

Overview... 42 Setup Tab Selections... 44 Options ... 45 Default Folder ... 46 Default Folder of Exams... 46 Save and Confirm Configuration Changes... 48 Default Folder of Version 4.0 ... 49 Net Share Folder ... 51 Exam Name Combination ... 53 How to Set the Default Eye Type ... 54 Eye Type... 54 Eye Type Materials and Velocities... 55 Selecting the Default Eye Type... 56 How to Set the Default Formula ... 56 Formulas... 57 Selecting the Formula... 57 How to Set the Default Scan Method ... 57 Contact... 57

Immersion... 58 Selecting the Default Scan Method... 58 How to Set the Default Capture Mode... 59 Automatic... 59 Manual... 59 Selecting the Default Capture Mode... 59 Auto Restart... 59 How to Set the Auto Capture Mode ... 61 Audio Feedback on Live Scan... 62 How to Activate Audio Feedback on Live Scan... 62 Selecting the Default K Index ... 62 Selecting the Default K Index:... 62 Setting the IOL Step... 63 How to Adjust the IOL Step... 63 Target... 63 How to Set the Default Target Refraction... 63 Reset All to Defaults ... 64 Gain ... 65 Adjusting the Gain... 65 Import /Export ... 66 How to turn on Synergy Mode... 66 Snapshots/ Reports... 67 How to Activate the Export Snapshots Function... 67 How to Activate Save Patient Demographics to an XML File With Snapshot Function... 68 How to Activate the Show Snapshot in a Separate Window Function... 68 Select Folder to Export the Snapshot... 69 Default Folder... 69 How To Activate the Export Reports... 70 Print New Report to Default Printer... 70 Show Report in Separate Window... 70 Convert PDF to JPEG... 71 Select the Folder and Drive to Export Report... 71 R/W Test... 72 Facilities... 72 How to Add New Facilities... 72 Deleting Facilities... 74 Duplicate Facilities from Selected ... 75 Set Selected Facility as Default... 75 Save... 75 Physicians ... 76 How to Add a New Physician... 76

Deleting Physicians... 78 Set Selected Physician as Default ... 78 Save... 78 Users... 79 How to Add a New User... 79 Deleting Users... 81 Set Selected User as Default... 82 Save... 82 Eye Types ... 82 Overview... 82 To add a new Eye Type:... 83 Adding a New Lens Material ... 84 How to Add a New Lens Material... 84 How to Remove Lens Material ... 87 Adding a New Anterior/Vitreous Material... 88 How to Add a New Anterior/Vitreous Material... 88 How to Remove an Anterior/Vitreous Material ... 90 How to Create New Eye Type ... 91 How to Create a New Eye Type Based on a Previously Stored Eye Type... 98 How to Delete an Existing Eye Type... 100 Personalizing IOL Overview... 101 Personalizing Lens Constants... 101 How to Personalize Constants... 101 Auto Personalization... 102 Selecting the Patient Record to be Personalized... 105 Manual Entry of Personalization Information... 108 Overview... 108 Selecting IOL Group and Lens... 108 Manual Entry of a Patient Record to be Personalized... 110 Save and Confirm Configuration Changes... 112 Updating IOL Constant... 113 Deleting Postoperative Results... 114 Deleting Current Postoperative Result... 115 Deleting All Postoperative Results... 116 Save and Confirm Configuration Changes... 117

Chapter 6: Entering Patient Information... 118

Overview ... 118 Exam Tab ... 118 New A-scan Study... 119 Entering Information On New A-scan Plus Connect Study Screen... 120

Entering Data... 120 Moving Between Fields... 120 Selecting Items from a Drop Down List... 120 Patient Info... 120 Required Fields... 120 First and Last Name... 121 Medical Record Number... 121 Date of Birth... 122 Remark... 123 Control Unit Info... 124 Serial Number... 124 Name... 124 Facility... 125 Physician... 125 Operator... 126 How to Start Exam... 126 Recall Existing Patient... 127 Selecting Existing Patient for Rescan... 128 Selecting Rescan... 129 Import Patient Information from Previously Saved B-Scan Plus/ UBM Plus Information... 130 Selecting Existing B-scan/ UBM Patient for Rescan... 130 Delete Selected Exams Button... 132 Refresh List... 133 Select Folder... 133 Exams Folder... 134 Reset Exams Folder... 134 Manage Version 4.0 Exams... 134

Chapter 7: Measuring A Patient...135

Overview ... 135 Measurement Tab... 136 Eye Type... 137 How to Set the Eye Type... 137 Capture Method ... 138 Immersion ... 138 Contact ... 138 Display Range... 138 Gain... 139 OD/OS... 139 Rescan/Stop... 139 Auto/Manual Capture... 139

Auto Mode... 139 To Switch Between the Auto and Manual Modes... 140 Auto Restart... 140 Using the Footswitch... 140 Edit Exam... 141 Save Exam... 141 Snapshot... 141 Printing Records... 141 How to Print a Record... 142 Screen Printout Formats... 142 How to Select the Right Printout Format... 142 Sample Printouts... 142 Moving Gates... 144 Overview... 144 Available Gates/Threshold... 145 Selecting Gates/Threshold to Adjust... 145

Chapter 8: Performing Calculations... 147

Overview ... 147 Calculating the Lens... 147 Calculation after Corneal Refractive Surgery... 147 IOL Calculation Tab... 148 Overview... 148 Manage IOL Groups... 150 How to Manage IOL Groups:... 150 Manage IOL Groups Screen... 151 Entering IOL Group Information... 152 Clear... 156 Restore... 156 Remove Selected Groups... 157 Done... 157 Save Changes... 158 Select IOL Groups... 159 Selecting Formula... 159 Changing the AXL Value... 160 Selecting an Individual Measurement... 160 Entering an AXL Value... 160 Entering K1 and K2 Values... 161 How to Enter the K1, K2 Values... 162 Entering the Target Refraction... 162 Rx Surgery... 163 Overview... 163

Double K Method... 163 Determining Corneal Power after Refractive Surgery... 164 Post Rx Surg IOL Calculation Steps... 164 Changing Rx Surg Field to Yes... 165 Clinical History Method... 166 Clinical History Fields... 166 Contact Lens Method... 168 Shammas Clinical Method... 169 Calculation Results... 170 Formula Compare Feature... 170 Printing Records... 171 Screen Printout Formats... 171 How to Select the Right Printout Format... 171 How to Print a Record... 171 OD/OS... 171 Sample Printouts... 172 Save Exam... 172

Chapter 9: Synergy Mode... 173

Introduction... 173 How to turn on Synergy mode... 173 Network Folder or USB Disk Mode... 174 IOLMaster 500 version 7.7... 174 Setting up the A-Scan Plus Connect Synergy Software for IOLMaster 500 version 7.7... 175 IOL Master 500 version 7.5 or older (7.4, 7.3, etc)... 177 Operation of the Accutome A-Scan Plus Connect Software with IOL Master 500 version 7.7... 178

Chapter 10: Maintenance...180

General Maintenance... 180 Safety Inspection... 180 Visual Inspection... 180 Ultrasound Inspection... 180 Calibration of Accutome A-Scan Plus... 180

Chapter 11: Specifications...181

Overview... 181 Physical Specifications... 181 Environmental Specifications... 182 Measurement Accuracy... 183 Computer Specification... 183

Operating Modes... 184 Formula References... 185 Storage/Range Specifications... 186 Acoustic Output... 188 EMC Compliance Information... 189

Chapter 12: Warranty and Repairs... 190

Warranty... 190 Product Returns... 191 Service and Repair... 191 All Other Returns... 191 Non-returnable Merchandise... 191 Replacement Parts... 192 Documentation... 192

Appendix...193

List of Figures

Figure 1-1 Accutome A-Scan Plus Connect... 1 Figure 3-1 Control Unit and Probe Connector (Right Side of Instrument)... 15 Figure 3-2 Probe Connected... 16 Figure 3-3 Accutome Ultrasonic Probe Kit (PN 24-4001)... 17 Figure 3-4 Accutome Probe... 17 Figure 3-5 Probe Setup with Immersion Shell... 18 Figure 3-6 Probe with Goldman Tonometer Adapter... 18 Figure 3-7 Inserting the Probe into the Handle Extension... 19 Figure 3-8 Probe with Handle Extension and Insertion Tool... 20 Figure 3-9 Probe with Handle Extension... 20 Figure 3-10 A-Scan Plus Connect Control Unit Connect to a Laptop via USB Cable... 20 Figure 3-10 Accutome A-Scan Plus Connect Desktop Shortcut... 22 Figure 3-11 Main Screen Starting New Exam... 23 Figure 3-12 New A-scan Study Screen... 24 Figure 3-13 Entering New Patient Information... 24 Figure 3-14 Selection Facility... 25 Figure 3-15 Selection Physician... 26 Figure 3-16 Selecting Operator... 26 Figure 3-17 Click Done Creating a New Exam... 27 Figure 3-18 Measurement Screen... 27 Figure 3-19 Measuring Test Block... 28 Figure 3-21 Measurement Screen Shown... 29 Figure 3-22 Measurement Done... 31 Figure 3-23 IOL Calculation Screen... 32 Figure 3-24 K1, K2 Values... 33 Figure 3-25 Calculation Complete... 34 Figure 3-26 Saving a Report... 35 Figure 3-27 Click Yes to Save... 36 Figure 4-1 A-Scan Plus Connect Exams Screen... 38 Figure 4-2 Measure Screen... 39 Figure 4-3 IOL Calculation Screen Selected... 40 Figure 4-4 Setup Screen Selected... 41 Figure 5-1 Desktop Icon... 42 Figure 5-2 Select Setup Tab... 43 Figure 5-3 Setup Tab Opened... 44 Figure 5-4 Option Screen... 45 Figure 5-5 Selecting Main Exam Folder... 46 Figure 5-6 Browse For Folder... 47 Figure 5-7 Selecting Save Changes... 48 Figure 5-8 Are You Sure... 48 Figure 5-9 User Select, Default Folder of Version 4.0... 49 Figure 5-10 Windows Browser - Locate Exam Folder... 50 Figure 5-11 Net Share... 51

Figure 5-12 Windows Browser - Locate Exam Folder... 52 Figure 5-13 Selecting Exam Name Combinations... 53 Table 5-2 Eye Types... 55 Table 5-3 Lens Materials and Velocities... 55 Table 5-4 Anterior/Vitreous Materials and Velocities... 55 Figure 5-14 Selecting the Default Eye Group... 56 Figure 5-15 Selecting the Default Formula... 57 Figure 5-16 Selecting Default Scan Method... 58 Figure 5-17 Selecting Default Capture Mode... 60 Figure 5-18 Selecting the K Index... 63 Figure 5-19 Selecting Save Changes... 64 Figure 5-20 Are You Sure... 64 Figure 5-21 Gain Adjustment Knob... 65 Figure 5-22 Turn On the Synergy Mode... 66 Figure 5-23 Selecting the Snapshot Format... 67 Figure 5-24 Snapshot Selection Completed... 68 Figure 5-25 Selecting Network Location... 69 Figure 5-26 Activating Export Report... 70 Figure 5-27 Selecting Network Location... 71 Figure 5-28 Successful Read Write Test... 72 Figure 5-29 Selecting “New” Facility... 72 Figure 5-30 Facility Information Being Entered... 73 Figure 5-31 Are You Sure... 74 Figure 5-32 Are You Sure... 75 Figure 5-33 Physicians Screen... 76 Figure 5-34 Physician Name Entered... 77 Figure 5-35 Are You Sure... 77 Figure 5-36 Are You Sure... 78 Figure 5-37 Users Screen... 79 Figure 5-38 New User Information... 80 Figure 5-39 Are You Sure... 81 Figure 5-40 Are You Sure... 81 Figure 5-41 Are You Sure... 82 Figure 5-42 Additional Eye Types... 83 Figure 5-43 Eye Type Screen... 83 Figure 5-44 New Lens Material Window Activated... 84 Figure 5-45 New Lens Material Entered... 85 Figure 5-46 Are You Sure... 86 Figure 5-47 Are You Sure You Want to Remove... 87 Figure 5-48 New Anterior/Vitreous Material Window Activated... 88 Figure 5-49 New Anterior/Vitreous Material Entered... 89 Figure 5-50 Are You Sure... 90 Figure 5-51 Are You Sure You Want to Remove... 90 Figure 5-52 Are You Sure... 90 Figure 5-53 Creating a New Eye Type... 91

Figure 5-54 New Eye Type Window Opened... 92 Figure 5-55 New Eye Type Name Entered... 93 Figure 5-56 Selecting Lens Material... 94 Figure 5-57 Entering Assumed Thickness... 95 Figure 5-58 Selecting the AC Material... 96 Figure 5-59 Selecting Vitreous Material... 97 Figure 5-60 Are You Sure... 98 Figure 5-61 Create New Eye Type From Existing Eye Type... 98 Figure 5-62 New Eye Type Completed... 99 Figure 5-63 Are You Sure... 99 Figure 5-64 Are You Sure... 100 Figure 5-65 IOL Personalization... 102 Figure 5-66 Selecting IOL Group... 103 Figure 5-67 Selecting Lens to be Personalized... 103 Figure 5-68 Selecting the Formula... 104 Figure 5-69 Files Transferred... 105 Figure 5-70 Selecting Patients to be Personalized... 106 Figure 5-71 Power of Lens Entered... 106 Figure 5-72 Multiple Entries Completed... 107 Figure 5-73 Unlock IOL Groups... 108 Figure 5-74 Select Lens... 109 Figure 5-75 Selecting the Formula... 110 Figure 5-76 Select Manual Enter... 110 Figure 5-77 Manual Entry... 111 Figure 5-78 Selecting Save Changes... 112 Figure 5-79 Are You Sure... 113 Figure 5-80 Are You Sure... 114 Figure 5-81 Are You Sure... 115 Figure 5-82 Are You Sure... 116 Figure 5-83 Selecting Save Changes... 117 Figure 5-84 Are You Sure... 117 Figure 6-1 Selecting New Exam... 119 Figure 6-2 Create New A-scan Exam... 119 Figure 6-3 New A-Scan Study Screen... 121 Figure 6-4 Medical Record Number Field... 121 Figure 6-5 Entering Patients Date of Birth... 122 Figure 6-6 Entering Patients Gender... 122 Figure 6-7 Entering Remark... 123 Figure 6-8 Control Unit Info... 124 Figure 6-9 Selecting Facility... 125 Figure 6-10 Selecting Physician... 125 Figure 6-11 Selecting Operator... 126 Figure 6-12 Starting New Exam, Click Done... 126 Figure 6-13 Measurement Screen... 127 Figure 6-14 Recalled Patient Record... 128

Figure 6-15 Select Rescan to Start Measurement... 129 Figure 6-16 Rescan Are You Sure... 129 Figure 6-17 Exams Tab... 130 Figure 6-18 Import B-scan Exam... 131 Figure 6-19 List of Saved B-Scans... 131 Figure 6-20 Selecting a Patient Record to Delete... 132 Figure 6-21 Are You Sure... 133 Figure 6-22 Select Folder Open... 133 Figure 6-24 Manage Version 4.0 Section... 134 Figure 7-1 Measurement Screen... 136 Figure 7-2 Select Eye Type... 137 Figure 7-3 Sclera and Retina Activated... 140 Figure 7-4 Measurement Reports... 143 Figure 7-5 Calculation Reports... 143 Figure 7-6 Gates... 145 Figure 7-7 Reset Gates... 146 Figure 8-1 IOL Calculation Screen... 148 Figure 8-2 IOL Calculation Screen... 149 Figure 8-3 Manage IOL Groups Screen... 150 Figure 8-4 IOL Groups Screen Opened... 151 Figure 8-5 Select New IOL Group... 152 Figure 8-6 New IOL Group Selected... 152 Figure 8-7 Group Name Added... 153 Figure 8-8 Entering the Description of the Lens... 153 Figure 8-9 Entering A-Constant... 155 Figure 8-10 First Lens Entered... 155 Figure 8-11 Lens Group Completed and Locked... 156 Figure 8-12 Selecting Lens Group to be Removed... 157 Figure 8-13 Save Changes... 158 Figure 8-14 Selecting IOL Group... 159 Figure 8-15 Formula Selected... 159 Figure 8-16 K1 and K2, Target Fields... 162 Figure 8-17 Changed Rx Surg Field... 165 Figure 8-18 K-Post Formula Selection Window Open... 167 Figure 8-19 Post Rx on Completion of Contact Lens Method... 168 Figure 8-20 Post Rx on Completion of Shammas Method... 169 Figure 8-21 Compare All Featured Turned On... 170 Figure 8-22 Print Icon... 171 Figure 9-2 Setup Screen... 173 Figure 9-3 Import/Export Screen... 174 Figure 9-4 Import/Export Screen... 176 Figure 9-5 Export Icon... 177 Table 11-1 Accutome A-Scan Plus Control Unit Physical Specifications... 181 Table 11-2 Accutome A-Scan Plus Connect Physical Specifications... 182 Table 11-3 Environmental Specifications... 182

Table 11-4 Measurement Accuracy... 183 Table 11-5 Recommended Computer Specifications... 184 Table 11-6 Operating Mode(s)... 184 Table 11-7 Formula References... 185 Table 11-8 Data Specifications... 186 Table 11-9 Data Specifications... 187 Table 10-11 Acoustic Output Reporting Table for Track 1 Non-Autoscanning Mode... 188 Table 11-11 Acoustic Output Reporting Table for Track 1 Non-Autoscanning Mode... 189 Table 12-1 Accutome Replacement Parts... 192 Table A-1 A-Scan Plus Connect System Messages... 193 Table A-1 A-Scan Plus Connect System Messages... 194

All Accutome A-Scan Plus Connect units are manufactured by Accutome, Inc. at: 3222 Phoenixville Pike Malvern, PA 19355 USA

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Introduction

Chapter 1: Introduction

Accutome A-Scan Plus Connect Overview The Accutome A-Scan Plus Connect pictured below has all the features that make it easy to obtain scans with extreme accuracy and improved patient outcomes.

Figure 1-1 Accutome A-Scan Plus Connect

Accutome A-Scan Plus Connect

User’s Guide

Features The Accutome A-scan Plus Connect is designed for easy access to all screens and functions. The windows based software and proprietary universal interface provides unsurpassed ease of use and the straightforward Graphical User Interface guides you through every operation. What you can’t see on the surface is also important. Industry-leading signal acquisition and processing helps you assure accurate measurements. Reliable design and efficient manufacturing provide fiscal value. Upgradable software protects your investment. The A-Scan provides the following general features: • Use on any Windows based computer • Universal interface and probe • Easily updated software • Provides a variety of printouts • Portable Measurements The accuracy of the Accutome A-Scan Plus Connect measurement is provided by the following: • High-resolution, real-time waveform display • High-speed digitalization acquires over 4000 points per waveform • Continuous display of Axial Length, ACD, Lens Thickness, and Vitreous dimensions • Audible feedback of contact and capture • Immersion mode yields improved accuracy - Contact mode also supported • Automatically or Manually capture up to 5 waveforms for each eye • Adjustable Gain, Velocities, Gates, and Amplitude Thresholds • Modify all waveform parameters using real-time or frozen waveforms • Predefined Eye Types and Velocities handle most situations such as phakic, dense cataract, three types of pseudo-phakic, aphakic, silicone oil filled, and even phakic ICL eyes. All velocities are fully adjustable • Custom Eye Types and Material Velocities can be created to handle individual preferences, special pathologies, or future trends • Highly sensitive 10MHz composite Broadband probe features a fixation light and multiple mounting options 2

Introduction IOL Calculations The Accutome A-Scan Plus Connect is also a leader in IOL Calculations and provides the following: • Modern formulas including Hoffer Q, Holladay, SRK/T, and Haigis • Compare results of all formulas simultaneously on a single screen for selected lenses • Instantly calculates emmetropic and targeted ametropoic IOL powers for dozens of lenses, viewed four at a time, using the average of selected waveforms, a single waveform, or manually entered data • Conveniently group lenses by favorite designation such as surgeon, user, type, manufacturer, etc. • Personalization of IOL Constants is easy and straightforward, encouraging improved patient outcomes • Maintains individual IOL Constants for each formula. Clearly identifies which IOL constant is used with the selected formula • IOL Calculation for Post Refractive Surgery Patients Components The components that are standard with each Accutome A-Scan Plus Connect instrument are: • Ultrasonic probe • Control Unit • Footswitch • Software CD which contains: • User’s Guide • System Software (to be loaded onto PC) • A-B Type USB Cable • Test Block • Installation Instructions • Quick Reference Guide Optional Components There is an additional component which further simplifies the use of the Accutome A-Scan Plus Connect: • Immersion Shell

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Accutome A-Scan Plus Connect

User’s Guide

About this Manual Chapter 2

Safety

Summarizes safety precautions, warnings, symbols, and terms.

Chapter 3

Getting Started

Provides assembly instructions, overview of Accutome A-Scan Plus Connect basic operation.

Chapter 4

How to navigate screens and buttons

Describes the interface and how to use all the buttons and screens.

Chapter 5

Setting up personal Preferences

Provides instructions on how to set up custom eye types and system personal preferences.

Chapter 6

Entering Patient Information

Provides instructions on how to create a new exam and enter patient’s information.

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Introduction

Chapter 7

Measuring Patient

Describes how to measure an eye.

Chapter 8

Performing Calculations

Describes the steps necessary to calculate IOL Power.

Chapter 9

Synergy Mode

Provides instructions on how to set up and use the Synergy Software

Chapter 10

Maintenance

Provides general maintenance instructions.

Chapter 11

Specifications

Provides Accutome A-Scan Plus Connect physical and operational specifications.

Chapter 12

Warranty and Repairs

Describes Accutome A-Scan Plus Connect warranty information and repair procedures.

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