A-Scan Synergy Users Guide Rev B

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): Emergo Europe P.O. Box 18510 2502 EM The Hague The Netherlands Tel: (31) 70 345 8570 Fax: (31) 70 346 7299

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Table of Contents

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

Safety...6 Safety Information...6 Safety Issues to Consider When Using the Accutome A-Scan Synergy...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

Getting Started...12 Assembling the Accutome A-Scan Synergy...12 What you need...12 Probe...13 Footswitch...13 Battery Specification and Installation...13 Placing the Accutome A-Scan Synergy...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 Synergy...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

How to Use the Buttons and Screens...43 Overview...43 Accutome A-Scan Synergy 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...46 Soft Menu Buttons...46 Buttons that Toggle between Two Selections...47 Buttons that Display Other Screens or Soft Menus...47 Accutome A-Scan Synergy 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

Preferences...56 Setting Up the Accutome A-Scan Synergy...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 Set the Default Patient Eye Type...96 How to Set the Default ID...99 How to Set the Default Gain...102 How to Set the Target Refraction...104 How to Set the K Index...107 How to Set the IOL Step...110 How to Adjust the Date and Time...114 How to Set the Auto Mode ...117 Sound On/Sound Off...123 Restart On/Restart Off...123 Scr Save On/Scr Save Off...123 Save and Restore Factory Default Gates and Threshold...124 About This Unit...124

Performing Measurements...126 Overview...126 Measure Screen...127 Information Displayed on the Measure Screen...128 Soft Menu Selections...128 Starting a New Patient...129 How to Set the Eye Type...129 Eye Types...129 Eye Type Materials and Velocities...130 Table 6-1 Eye Types...130 Table 6-2 Lens Materials and Velocities...130 Table 6-3 Anterior/Vitrous Materials and Velocities...130 Setting the Eye Type...131 Probe Application Methods...133 Immersion...133 Contact...134 Capture Modes...134 Auto Mode...134 Manual Mode...135 How to Capture a Waveform...135 Using the Footswitch...135 Using the Running/Frozen Button...135 Using the Measure Button...136

How to Select a Measurement...136 Selecting a Measurement with the Knob...136 Selecting a Measurement Using Waveform Review Menu...137 Selecting a Measurement with the Footswitch...138 How to Delete a Measurement...139 Deleting a Measurement with X Button or Keyboard...139 Deleting a Measurement with the Footswitch...139

How to Adjust Gates/Threshold...139

Available Gates/Threshold...140 Selecting Gates/Threshold ...141 Waveform Review Menu ...142 How to Adjust the Cornea Gate...142 How to Adjust the Anterior Lens Gate...143 How to Adjust the Posterior Lens Gate...145 How to Adjust the Retina Gate...146 How to Apply Gate Adjustments to All Waveforms...148 How to Adjust the Gain...149 How to Use Zoom ...151 How to Scroll...152 Switching Eyes...154 Customize Eye Type...154

Customizing Eye Types...155 Overview...155 Customize Eye Type Screen...156 Customize Fields and Menu Selections...156 OD...156 OS...156 Eye Type Table...156 AC...156 Lens...156 VC...156

How to Customize an Eye Type...157

Performing Calculations...164 Overview...164

Calculating the Lens...164 Calculation after Corneal Refractive Surgery ...164 Calculate IOL Screen...166 Selecting an IOL Group...167 Selecting a Formula...167 Patient Customization...155 Entering an ACD Value with the Haigis Formula...167 Changing the AXL Value...168 Selecting a Measurement...168 Entering an AXL Value...169 Entering the K1, K2 Values...169 Entering the K1, K2 Values...171 Calculation Results...171 Formula Compare Feature...172 Switching Between OD/OS...173

Calculating IOL Power After Corneal Refractive Surgery...174 Double K Method...174 Determining Corneal Power after Refractive Surgery...175 Post Rx Surg IOL Calculation Steps...175 Changing Rx Surg Field to Yes...176 Clinical History Method...177 Clinical History Fields...177 Contact Lens Method...178 Shammas Clinical Method ...179 Calculation Results...180 Switching Between OD/OS...180

Setting Up IOL Groups...181 How are IOL Groups Used...181 How to Set Up an IOL Group...181 Accessing the IOL Groups Screen...181 IOL Calculation Groups Screen...182 Entering IOL Group Names...183 Entering the Group’s Lenses...184

Personalizing Lens Constants...190 Overview...190 Personalizing Lens Constants...190 How to Personalize Constants...191 Accessing the Personalize IOLs Screen...191 Personalize IOLs Screen...192 Personalize IOLs Screen Soft Menus...193 Selecting an IOL Group and Lens...193 Next IOL/Group...193 Selecting IOL Group with the Knob...194 Entering Postoperative Results...194 Pasting Patient Information...195 Manually Entering Patient Information ...196 Entering Remaining Postoperative Results...197 Deleting Postoperative Results...197 Deleting Current Postoperative Result...197 Deleting All Postoperative Results...198 How to View Individual Results for a Formula...198 How to Sort Postoperative Results...198 How to Update IOL Constants...199 Update IOL Constants Screen...200 Selecting an IOL Group and Lens...201

Storing and Recalling Records...203 Overview...203 How to Store a Record...203 How to Recall a Record...205 How to Adjust Parameters on Saved Records...207 How to Update Calculations...207 How to Sort Patient Records...208

Printing Records...209

How to Print a Record...209 Screen Printout Formats...209 How to Select the Right Printout Format...210 Sample Printouts...210 How to Batch Print...212

Required Printer...215

Maintenance...216 General Maintenance...216 Safety Inspections...216 Visual Inspection ...216 Ultrasound Inspection...216 Calibration of Accutome A-Scan Synergy...217 Battery Disposal...217 Instructions for Disposal...217 Disposal in Europe...217 Disposal in US...218

Specifications...220 Overview...220 Physical Specifications...220 Table 14-1 Accutome A-Scan Synergy Physical Specifications...220 Table 14-2 Accutome A-Scan Synergy Physical Specifications ...221 Environmental Specifications...221 Table 14-3 Environmental Specifications...222 Measurement Accuracy...222 Table 14-4 Measurement Accuracy...222 Operating Modes...223 Table 14-5 Operating Mode(s)...223 Formula References...224 Table 14-6 Formula References...224 Storage/Range Specifications...225 Table 14-7 Data Specifications...225 Table 14-8 Data Specifications...226 Acoustic Output ...227 Table 14-9 Acoustic Output Reporting Table for Track 1 ...227 Non-Autoscanning Mode...227 Table 14-10 Acoustic Output Reporting Table for Track 1...228 Non-Autoscanning Mode...228

EMC Compliance Information...228

Table 14-11 Guidance and manufacturer’s declaration...230 Table 14-12 Guidance and manufacturer’s declaration...230 Table 14-12 Guidance and manufacturer’s declaration...231 Table 14-13 Guidance and manufacturer’s declaration ...232 Table 14-14 Recommended separation distances...234

Warranty and Repairs...235 Warranty...235 Product Returns...236 Service and Repair...236 All Other Returns ...236 Non-Returnable Merchandise...236 Replacement Parts...237 Table 15-1 Accutome Replacement Parts...237 Documentation...237 Network Addendum...238

List of Figures Figure 1-1 Accutome A-Scan Synergy...1 Figure 3-1 Accutome A-Scan Synergy 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 Synergy...24 Figure 3-15 Measure Screen Displayed...25 Figure 3-16 Accutome A-Scan Synergy 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 Synergy Buttons... ...44 Figure 4-2 Accutome A-Scan Synergy 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 Contrast Field Activated...94 Figure 5-39 Adjusting the Contrast...95 Figure 5-40 Contrast Adjusted...96 Figure 5-41 Default Eye Type Field Selected ...97 Figure 5-42 Default Eye Type Field Activated...97 Figure 5-43 New Default Eye Type Selected ...98 Figure 5-44 Default Eye Type Changed...99 Figure 5-45 Default ID Field Selected...100 Figure 5-46 Default ID Field Activated...101 Figure 5-47 Entering the Default ID...101

Figure 6-8 Waveform Review Menu Activated...142 Figure 6-9 Cornea Gate Selected...143 Figure 6-10 Anterior Lens Gate Selected ...144 Figure 6-11 Posterior Lens Gate Selected...146 Figure 6-12 Retina Gate Selected...147 Figure 6-13 Threshold Gate Selected...148 Figure 6-14 Gain Selected...149 Figure 6-15 Gain Field Changed...150 Figure 6-16 Zoom Selected...151 Figure 6-17 Zoom Changed...152 Figure 6-18 Scroll Selected...153 Figure 6-19 Measurement Scrolling Changed...154 Figure 7-1 Customize Eye Type Screen...157 Figure 7-2 OS Materials Table Selected...158 Figure 7-3 OS Materials Table Activated...159 Figure 7-4 Changing VC Material...160 Figure 7-5 VC Material Cell Changed...161 Figure 7-6 Changing Velocity Field ...162 Figure 7-7 OS Eye Type Customized...163 Figure 8-1 Calculate Button...165 Figure 8-2 Calculation Fields...166 Figure 8-3 Calculate IOL Screen - All Fields Entered...172 Figure 8-4 Compare On Selected...173 Figure 8-5 Post Rx Surgery Field...176 Figure 8-6 Post Rx Surgery Calculation Activated ...177 Figure 8-7 Post Rx Surgery Calculation with Contact Lens Method...178 Figure 8-8 Post Rx Surgery Calculation with Shammas Clinical Method...179 Figure 9-1 Select IOL Groups...182 Figure 9-2 IOL Groups Screen...183 Figure 9-3 Entering the IOL Group Name...184 Figure 9-4 Entering the IOL Description...185 Figure 9-5 Selecting the A-Constant Field...186 Figure 9-6 Entering the IOL Constant...187 Figure 9-7 First Lens Entered for Group 1...188 Figure 9-8 First IOL Group Complete...189 Figure 10-1 Calculate IOL Screen - IOL Groups Selection...191 Figure 10-2 Personalize IOLs Screen...192 Figure 10-3 Update IOL Constants Screen...200 Figure 11-1 Patient Record Screen...204 Figure 11-2 Patient Record Stored...205 Figure 11-3 Recalling a Patient Record...206

Figure 11-4 Recalled Patient Record...207 Figure 12-1 Measurement Printout...210 Figure 12-2 Calculation Printout and Patient Record Screen...211 Figure 12-3 Saved Patient Record Screen...212 Figure 12-4 Print Menu Screen...213 Figure 12-5 Saved Patient Records - Select for Batch Print...214

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

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Introduction

Introduction

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

Figure 1-1 Accutome A-Scan Synergy

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Accutome A-Scan Synergy

User’s Guide

Features

The Accutome A-scan Synergy 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 Synergy 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

Measurements The accuracy of the Accutome A-Scan Synergy 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 Synergy 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 Synergy instrument are: • • • •

Ultrasonic probe Power Supply Footswitch Keyboard

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Accutome A-Scan Synergy

User’s Guide

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

External Printer Prager 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 Synergy 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.

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