A-Scan Plus Users Guide Rev A

Table of Contents Chapter 1: Introduction...1

Accutome A-Scan Plus Overview...1 Features...2

Measurements...2 IOL Calculations...3 Components...3 Optional Components...4 About this Manual...4

Chapter 2: Safety...6 Safety Information...6

Safety Issues to Consider When Using the Accutome A-Scan Plus...6 Indications for use...6 Symbols Definitions for the Accutome...7 Safety Precautions...8 Sterilization...8 Disinfection and Cleaning...9 Electrical Hazard and Safety...10 Avoiding Equipment Damage...10 Avoiding Electromagnetic and Other Interference...11 ALARA Principle...11

Chapter 3: Getting Started...12

Assembling the Accutome A-Scan Plus...12

What you need...12 Probe...13 Footswitch...13 Battery Specification and Installation...13 Placing the Accutome A-Scan Plus...14 Quick-Close Kickstand...14 Mounting...15 Connecting the Components...15 Connecting the Footswitch...16 Connecting the Power...16 Connecting the Ethernet Connection...17

Connecting the USB Keyboard and USB disk...17 Connecting the RS232 Connector...17 Connecting the Probe...18 Probe Setup...19 Accutome Ultrasonic Probe Kit...20 Accutome Probe with Goldman Tonometer Adapter...21 Accutome Probe with Handle Extension...22 Basic Operation...24 How to Power On the Accutome A-Scan Plus...24 How to Adjust the Contrast...25 Using the Test Block...26 Preparation of Patient for Examination...27 How to Start a New Patient...27 How to Enter Text without a Keyboard...31 Screen Keyboard Features...32 Entering a Patient with the Screen Keyboard...33 How to Take a Measurement...34 How to Perform a Calculation...36 How to Print a Records...41 How to Save Patient Records...41

Chapter 4: How to Use the Buttons and Screens...43

Overview...43 Accutome A-Scan Plus Buttons...44 Dedicated Buttons...44 Measure Button...45 Patient Record Button...45 Calculate...45 Preferences...45 Print...46 Check or Affirmative ( √ )...46 Negative or Delete (X)...46 Soft Menu Buttons...46 Buttons that Toggle between Two Selections...47 Buttons that Display Other Screens or Soft Menus...47 Accutome A-Scan Plus Knob...47 How the Knob Works...47 Screens...47 What the Screen Displays...48

Types of Information... ...48 Soft Menus...48 Tips...48 Sounds...48 Error Messages...49 Moving between Screens...49 Screen Hierarchy...49 High Level Screen Buttons...50 Top Level Screens...50 Associated Sub-Level Screens...50 From the Measure Screen...50 From the Patient Records Screen...51 From the Preferences Screen...51 How Buttons, Screens and Knob Work Together...51 Changing Fields and Table Cells...51 Changing Fields and Table Cells...51 Active Area...52 Text Entry...52 Selecting a New Active Area...52 Changing Fields in the Active Area...52 Pre-entered Fields...52 Fields Requiring Information...53 Numeric Fields...53 Keyboard Shortcuts...53 Using the Footswitch...55 Setting Up the Accutome A-Scan Plus...56

Chapter 5: Preferences...56 How to Access Preferences...57 Top Level of Preferences...58 How to Add a New Eye Type...59 Adding a New Lens Material...60 Assigning a Velocity to the New Lens Material...62 Adding the New Eye Type Information...63 Eye Type Screen Menu Selections...69 Reset Field to Factory...69 Reset All to Factory...72 More Settings...74 Setup Screen Fields...74

Setup Screen Soft Menu...75 How to Set the Printer...76 How to Set the Print Title...89 How to Select Automatic or Manual Network Address...93 How to Adjust the Contrast...96 How to Set the Default Patient Eye Type...100 How to Set the Default ID...103 How to Set the Default Gain...106 How to Set the Target Refraction...108 How to Set the K Index...111 How to Set the IOL Step...114 How to Activate the Network Folder...118 Configure Network Folder...119 Testing Network Connection on the A-Scan Plus... ..123 Connect to the PC folder... ..123 Troubleshooting the problems...123 How to Adjust the Date and Time...124 How to Set the Auto Mode ...127 Sound On/Sound Off...133 Restart On/Restart Off...133 Scr Save On/Scr Save Off...133 Save and Restore Factory Default Gates and Threshold...134 About This Unit...134 Overview...136

Chapter 6: Performing Measurements...136

Measure Screen...137

Information Displayed on the Measure Screen...138 Soft Menu Selections...138 Starting a New Patient...139 How to Set the Eye Type...139 Eye Types...139 Eye Type Materials and Velocities...140 Table 6-1 Eye Types...140 Table 6-2 Lens Materials and Velocities...140 Table 6-3 Anterior/Vitrous Materials and Velocities...140 Setting the Eye Type...141 Probe Application Methods...143 Immersion...143 Contact...144

Capture Modes...144

Auto Mode...144 Manual Mode...145 How to Capture a Waveform...145 Using the Footswitch...145 Using the Running/Frozen Button...145 Using the Measure Button...146 How to Select a Measurement...146 Selecting a Measurement with the Knob...146 Selecting a Measurement Using Waveform Review Menu...147 Selecting a Measurement with the Footswitch...148 How to Delete a Measurement...149 Deleting a Measurement with X Button or Keyboard...149 Deleting a Measurement with the Footswitch...149 How to Adjust Gates/Threshold...149 Available Gates/Threshold...150 Selecting Gates/Threshold...151 Waveform Review Menu...152 How to Adjust the Cornea Gate...152 How to Adjust the Anterior Lens Gate...153 How to Adjust the Posterior Lens Gate...155 How to Adjust the Retina Gate...156 How to Apply Gate Adjustments to All Wavefor...158 How to Adjust the Gain...159 How to Use Zoom...161 How to Scroll...162 Switching Eyes...164 Customize Eye Type...164 Overview...165 Patient Customization...165

Chapter 7: Customizing Eye Types...165

Customize Eye Type Screen...166

Customize Fields and Menu Selections...166 OD...166 OS...166 Eye Type Table...166 AC...166 Lens...166

VC...166 How to Customize an Eye Type...167 Overview...174 Calculating the Lens...174 Calculation after Corneal Refractive Surgery ...174

Chapter 8: Performing Calculations...174

Calculate IOL Screen...176

Selecting an IOL Group...177 Selecting a Formula...177 Entering an ACD Value with the Haigis Formula...177 Changing the AXL Value...178 Selecting a Measurement...178 Entering an AXL Value...179 Entering the K1, K2 Values...179 Entering the K1, K2 Values...181 Calculation Results...181 Formula Compare Feature ...182 Switching Between OD/OS...183 Calculating IOL Power After Corneal Refractive Surgery...184 Double K Method...184 Determining Corneal Power after Refractive Surgery...185 Post Rx Surg IOL Calculation Steps ...185 Changing Rx Surg Field to Yes...186 Clinical History Method...187 Clinical History Fields...187 Contact Lens Method...188 Shammas Clinical Method ...189 Calculation Results...190 Switching Between OD/OS...190

Chapter 9: Setting Up IOL Groups...191

How are IOL Groups Used...191 How to Set Up an IOL Group...191 IOL Calculation Groups Screen...192 Entering IOL Group Names...193 Entering the Group’s Lenses...194

Chapter 10: Personalizing Lens Constants...200

Overview...200 Personalizing Lens Constants...200 How to Personalize Constants...201 Accessing the Personalize IOLs Screen...201 Personalize IOLs Screen...202 Personalize IOLs Screen Soft Menus...203 Selecting an IOL Group and Lens...203 Next IOL/Group...203 Selecting IOL Group with the Knob...204 Entering Postoperative Results...204 Pasting Patient Information...205 Manually Entering Patient Information ...206 Entering Remaining Postoperative Results...207 Deleting Postoperative Results...207 Deleting Current Postoperative Result...207 Deleting All Postoperative Results...208 How to View Individual Results for a Formula...208 How to Sort Postoperative Results...208 How to Update IOL Constants...209 Update IOL Constants Screen...210 Selecting an IOL Group and Lens...211

Chapter 11: Storing and Recalling Records...213

How to Recall a Record...215 How to Adjust Parameters on Saved Records...217 How to Update Calculations...217 How to Sort Patient Records...218

Chapter 12: Printing Records...219 How to Print a Record...219 Screen Printout Formats...219 How to Select the Right Printout Format...220 Sample Printouts...220 How to Batch Print...222 Required Printer...225

Chapter 13: Maintenance...226 General Maintenance...226 Safety Inspections...226 Visual Inspection...226 Ultrasound Inspection...226 Calibration of Accutome A-Scan Plus...227 Battery Disposal...227 Instructions for Disposal...227 Disposal in Europe...227 Disposal in US...228

Chapter 14: Specifications...230

Overview...230 Physical Specifications...230 Table 14-1 Accutome A-Scan Plus Physical Specifications...230 Table 14-2 Accutome A-Scan Plus Physical Specifications...231 Environmental Specifications ...231 Table 14-3 Environmental Specifications...232 Measurement Accuracy...232 Table 14-4 Measurement Accuracy...232 Operating Modes...233 Table 14-5 Operating Mode(s)...233 Formula References...234 Table 14-6 Formula References...234 Storage/Range Specifications...235 Table 14-7 Data Specifications...235 Table 14-8 Data Specifications...236 Acoustic Output...237 Table 14-9 Acoustic Output Reporting Table for Track 1...237 Non-Autoscanning Mode...237 Table 14-10 Acoustic Output Reporting Table for Track 1...238 Non-Autoscanning Mode...238 EMC Compliance Information...238 Table 14-11 electromagnetic emissions...240 Table 14-12 electromagnetic immunity ...240 Table 14-12 electromagnetic immunity...241 Table 14-13 electromagnetic immunity...242 Table 14-14 Recommended separation distances ...244

Chapter 15: Warranty and Repairs...245

Warranty...245 Product Returns...246 Service and Repair...246 All Other Returns...246 Non-Returnable Merchandise...246 Replacement Parts...247 Table 15-1 Accutome Replacement Parts...247 Documentation...247 NetworkAddendum...248

List of Figures Figure 1-1 Accutome A-Scan Plus...1 Figure 3-1 Accutome A-Scan Plus Components...12 Figure 3-2 Closed Kickstand...14 Figure 3-3 Open Kickstand...15 Figure 3-4 Component Connectors...16 Figure 3-5 Probe Connector...18 Figure 3-6 Probe Connected...19 Figure 3-7 Accutome Ultrasonic Probe Kit...20 Figure 3-8 Accutome Probe...20 Figure 3-9 Probe Setup with Immersion Shell...21 Figure 3-10 Probe with Goldman Tonometer Adapter...21 Figure 3-11 Inserting the Probe into the Handle Extension...22 Figure 3-12 Probe with Handle Extension and Insertion Tool...23 Figure 3-13 Probe with Handle Extension...23 Figure 3-14 Turning on the Accutome A-Scan Plus...24 Figure 3-15 Measure Screen Displayed...25 Figure 3-16 Accutome A-Scan Plus Test Block...26 Figure 3-17 Measure Screen, Main Menu...27 Figure 3-18 Patient Information Field...28 Figure 3-19 Patient Information Field Opened...29 Figure 3-20 Enter Patient’s Last Name...29 Figure 3-21 Enter Patient Information...30 Figure 3-22 Screen Keyboard...31 Figure 3-23 Measurement Fields Selected...34 Figure 3-24 Measure Screen Displayed...36 Figure 3-25 Calculate IOL Screen...37 Figure 3-26 ACD Field Selected...38 Figure 3-27 K1, K2 Values...39 Figure 3-28 Calculation Completed...40 Figure 3-29 Patient Record Storage ...42 Figure 3-30 Patient Record Stored...42 Figure 4-1 Accutome A-Scan Plus Buttons...44 Figure 4-2 Accutome A-Scan Plus Screen Hierarchy...50 Figure 5-1 Preferences Button...57 Figure 5-2 Eye Types Screen...58 Figure 5-3 Selecting the Lens Materials Table...60 Figure 5-4 Selecting a Cell to Enter New Lens Material...61 Figure 5-5 Entering the Name for New Lens Material...62 Figure 5-6 Adding New Material Velocity...63

Figure 5-7 Selecting the Eye Type Name Cell...64 Figure 5-8 Adding the New Eye Type Name ...64 Figure 5-9 Activating the Area to Select New Lens Material...65 Figure 5-10 Lens Material Selected...66 Figure 5-11 Lens Thickness Entered...67 Figure 5-12 Anterior Chamber Material Selected...68 Figure 5-13 Vitreous Chamber Material Selected...69 Figure 5-14 Non-Factory Field...70 Figure 5-15 Restore Selected Field Prompt...71 Figure 5-16 Selected Field Restored...72 Figure 5-17 Non-Factory Fields Displayed...73 Figure 5-18 Restore All Fields Prompt...74 Figure 5-19 More Settings - Setup Screen...75 Figure 5-20 Printer Field Selected...76 Figure 5-21 Printer Field Open...77 Figure 5-22 Selecting the Printer...78 Figure 5-23 Printer Selected...79 Figure 5-24 Select Printer...80 Figure 5-25 Activate the Printer Field...81 Figure 5-26 Printer Selection “None”...82 Figure 5-27 New Patient Selected...83 Figure 5-28 Update Selected...84 Figure 5-29 Are You Sure?...85 Figure 5-30 Driver Update Complete...86 Figure 5-31 Select Printer Field...87 Figure 5-32 Selecting Custom Print Drives...88 Figure 5-33 Custom Print Drivers Selected...89 Figure 5-34 Print Title Field Selected...90 Figure 5-35 Print Title Field Activated...91 Figure 5-36 Entering the Print Title...92 Figure 5-37 Print Title Added...93 Figure 5-38 Selecting Automatic Network Address...94 Figure 5-39 Contrast Field Selected ...97 Figure 5-40 Contrast Field Activated...98 Figure 5-41 Adjusting the Contrast...99 Figure 5-42 Contrast Adjusted...100 Figure 5-43 Default Eye Type Field Selected ...101 Figure 5-44 Default Eye Type Field Activated...101 Figure 5-45 New Default Eye Type Selected ...102 Figure 5-46 Default Eye Type Changed...103 Figure 5-48 Default ID Field Activated...105 Figure 5-49 Entering the Default ID...105

Figure 5-50 Default ID Added...106 Figure 5-51 Default Gain Field Selected...107 Figure 5-52 Default Gain Field Changed...108 Figure 5-53 Target Field Selected...109 Figure 5-54 Target Field Activated...109 Figure 5-55 Adjusting the Target...110 Figure 5-56 Target Adjusted...111 Figure 5-57 K Index Field Selected...112 Figure 5-58 K Index Field Activated...113 Figure 5-59 Adjusting the K Index...113 Figure 5-60 K Index Field Adjusted ...114 Figure 5-61 IOL Step Field Selected...115 Figure 5-62 IOL Step Field Activated...115 Figure 5-63 Adjusting the IOL Step...116 Figure 5-64 IOL Step Adjusted...117 Figure 5-65 Selecting Network Folder On/Off...118 Figure 5-66 Configure Network Folder...119 Figure 5-67 Day Field Selected...124 Figure 5-68 Day Field Activated...125 Figure 5-69 Adjusting the Day...126 Figure 5-70 Day Adjusted ...127 Figure 5-71 Auto Mode Sclera Selected...129 Figure 5-72 Auto Mode Sclera Field Activated...129 Figure 5-73 Changing the Auto Mode - Turning On Sclera...130 Figure 5-74 Auto Mode - “Sclera” On...131 Figure 5-75 Auto Mode - “Stable” Selected...132 Figure 5-76 Auto Mode Defined by “Stable” Measurement...132 Figure 5-77 About This Unit Screen...135 Figure 6-1 Measure Screen Displaying Current Settings...137 Figure 6-2 Eye Type Selected...141 Figure 6-3 Eye Type Active...142 Figure 6-4 Eye Type Changed...143 Figure 6-5 Measurement Selected...147 Figure 6-6 Measurement Activated with Waveform Review Menu...148 Figure 6-7 Current Measurement Waveform Selected ...151 Figure 6-8 Waveform Review Menu Activated...152 Figure 6-9 Cornea Gate Selected...153 Figure 6-10 Anterior Lens Gate Selected...154 Figure 6-11 Posterior Lens Gate Selected...156 Figure 6-12 Retina Gate Selected...157 Figure 6-13 Threshold Gate Selected...158

Figure 6-14 Gain Selected ...159 Figure 6-15 Gain Field Changed...160 Figure 6-16 Zoom Selected...161 Figure 6-17 Zoom Changed...162 Figure 6-18 Scroll Selected...163 Figure 6-19 Measurement Scrolling Changed...164 Figure 7-1 Customize Eye Type Screen...167 Figure 7-2 OS Materials Table Selected...168 Figure 7-3 OS Materials Table Activated...169 Figure 7-4 Changing VC Material...170 Figure 7-5 VC Material Cell Changed...171 Figure 7-6 Changing Velocity Field...172 Figure 7-7 OS Eye Type Customized...173 Figure 8-1 Calculate Button...175 Figure 8-2 Calculation Fields...176 Figure 8-3 Calculate IOL Screen - All Fields Entered...182 Figure 8-4 Compare On Selected...183 Figure 8-5 Post Rx Surgery Field (Rx Surg) Selected...186 Figure 8-6 Post Rx Surgery Calculation Activated - Clinical History...187 Figure 8-7 Post Rx Surgery Calculation with Contact Lens Method...188 Figure 8-8 Post Rx Surgery Calculation with Shammas Clinical Method...189 Figure 9-1 Select IOL Groups...192 Figure 9-2 IOL Groups Screen...193 Figure 9-3 Entering the IOL Group Name...194 Figure 9-4 Entering the IOL Description...195 Figure 9-5 Selecting the A-Constant Field...196 Figure 9-6 Entering the IOL Constant...197 Figure 9-7 First Lens Entered for Group 1...198 Figure 9-8 First IOL Group Complete...199 Figure 10-1 Calculate IOL Screen - IOL Groups Selection...201 Figure 10-2 Personalize IOLs Screen...202 Figure 10-3 Update IOL Constants Screen...210 Figure 11-1 Patient Record Screen...214 Figure 11-2 Patient Record Stored...215 Figure 11-3 Recalling a Patient Record...216 Figure 11-4 Recalled Patient Record...217 Figure 12-1 Measurement Printout...220 Figure 12-2 Calculation Printout and Patient Record Screen...221 Figure 12-3 Saved Patient Record Screen...222 Figure 12-4 Print Menu Screen...223 Figure 12-5 Saved Patient Records - Select for Batch Print...224

All Accutome A-Scan units are manufactured by Accutome Ultrasound at: 3222 Phoenixville Pike Malvern, PA 19355 USA

1

Introduction

Introduction

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

Figure 1-1 Accutome A-Scan Plus

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Accutome A-Scan Plus

User’s Guide

Features

The Accutome A-scan Plus is designed for easy access to all screens and functions. The advanced User Input Knob 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. Upgradeable software protects your investment. The Accutome A-Scan Plus lets you accomplish even the complex simply. The A-Scan provides the following general features: • • • • • •

Large 7.5 inch high resolution LCD screen with intuitive User Interface Rotary User Input knob and dedicated tactile buttons External, universal input, worldwide power supply Desktop, slit lamp, or wall mountable Provides a variety of printouts 1.9” thick, portable

Measurements The accuracy of the Accutome A-Scan Plus measurement is provided by the following: • • • • • • • • •

High-resolution, real-time waveform display with up to 8X zoom pinpoints tissue boundaries High-speed digitalization acquires over 4000 points per waveform Continuous display of Axial Length, ACD, Lens Thickness, and Vitreous dimensions Audible feedback of contact, signal quality, and capture Immersion mode yields improved accuracy - Contact mode also supported Automatically or Manually capture up to 5 waveforms for each eye Adjustable Gain, Time Gates, and Amplitude Thresholds Modify all waveform parameters using real-time or frozen waveforms On-the-Fly customization makes unique patients a breeze 2

Introduction • • •

Features

Predefined Eye Types and Velocities handle most situations such as phakic, dense cataract, three pseudo-phakic, aphakic, and even silicone oil filled 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 fixation and multiple mounting options

IOL Calculations The Accutome A-Scan Plus 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 three 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 instrument are: • • • •

Ultrasonic probe Power Supply Footswitch Keyboard

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Accutome A-Scan Plus

User’s Guide

Optional Components There are also several optional components which further simplify the use of the Accutome A-Scan: • • •

External Printer Immersion Shell Mounting Options

About this Manual Section 2

Safety

Summarizes safety precautions, warnings, symbols, and terms.

Section 3

Getting Started

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

Section 4

How to Use the Accutome Buttons and Screens

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

Section 5

Accutome A-Scan Preferences

Provides instructions on how to set up eye types and system operational functions.

Section 6

Performing Measurements

Provides detailed instructions on how to perform A-Scan measurements.

Section 7

Customizing Eye Types

Describes how to customize an eye type for an individual patient.

4

Introduction

About this Manual

Section 8

Performing Calculations

Describes the steps necessary to calculate IOL Power.

Section 9

Setting Up IOL Groups

Describes how to set up groups of IOLs for easy access.

Section 10

Personalizing Lens Constants

Provides instructions on why and how to personalize lens constants.

Section 11

Storing and Recalling Patient Records

Provides instructions on how to save and recall patient records, and make adjustments to saved records.

Section 12

Maintenance

Provides general maintenance instructions.

Section 13

Specifications

Provides Accutome A-Scan physical and operational specifications.

Section 14

Warranty and Repairs

Section 15

Printing

Describes Accutome A-Scan warranty information and repair procedures.

Section 16

A-Scan Manager

Section 17

Networking

Describes use of A-Scan Manager-A program that connects print outs to post script format allowing easy file sharing.

Having read this manual you will be able to assemble the Accutome A-Scan, take measurements, calculate IOL power, customize IOL constants and eye types, and save Patient records.

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