Accutome a-scan plus User manual

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 ofce 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 or 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 modications 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):
The A-Scan Plus Connect is Manufactured by:
Accutome, Inc.
3222 Phoenixville Pike
Malvern, PA 19355 USA
Toll Free (USA): 1-800-979-2020
International: 610-889-0200
Fax: [phone]

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 Denitions 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 Specications................................................................ 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 Conrm Conguration 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 Conrm Conguration Changes. .................................................. 112
Updating IOL Constant. ............................................................................... 113
Deleting Postoperative Results..................................................................... 114
Deleting Current Postoperative Result......................................................... 115
Deleting All Postoperative Results............................................................... 116
Save and Conrm Conguration 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: Specications...............................................................181
Overview......................................................................................................... 181
Physical Specications................................................................................... 181
Environmental Specications....................................................................... 182
Measurement Accuracy................................................................................. 183
Computer Specication................................................................................. 183

Operating Modes............................................................................................ 184
Formula References....................................................................................... 185
Storage/Range Specications........................................................................ 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