Accutome A-scan Plus Connect User Manual

A-Scan Plus Connect User’s Guide

24-4416 Rev-D

Accutome A-Scan Plus Connect 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 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):

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]

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ii

Table Of Contents

Chapter 1: Introduction 1

Accutome A-Scan Plus Connect Overview 1
Features 2
Measurements 2
IOL Calculations 2
Components 3

Optional Components 3

About this Manual 3

Chapter 2: Safety 5

Safety Information 5

Safety Issues to Consider When Using the
Accutome A-Scan Plus Connect 5
Indications for use 5
Side Effects 5
Contraindications 5

Symbol Definitions for the Accutome A-Scan Plus Connect 6
Disinfection and Cleaning 6
Safety Precautions 6
Cleaning Procedure at Point of Use 7
Disinfection of the Probes with Alcohol 7
High- Level Disinfection of the Probe 7
Electrical Hazard and Safety 7
Avoiding Equipment Damage 8

Avoiding Electromagnetic and Other Interference 8

Chapter 3: Getting Started 9

Assembling the Accutome A-Scan Plus Connect 9

What you Need 9

Personal Computer Specifications 10
A-Scan Plus Connect Control Unit 10

A-Scan Plus Connect 10MHz Composite A-Probe 10
USB Foot Switch 10
A-B Type USB Cable (Control Unit to Computer) 10
Printer 10

Accutome A-Scan Plus Connect Software 10
Assembling the A-Scan Plus Connect 11

Connecting the Probe 11

Probe Setup 12

Accutome Ultrasonic Probe Kit (PN 24-4001) 12
Accutome Probe with Goldman Tonometer Adapter 13
Accutome Probe with Handle Extension 13

Connecting the A-Scan Plus Connect to the Computer 14

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Accutome A-Scan Plus Connect Manual

Installation of the Software 14

Basic Operation 15

Starting Accutome A-Scan Plus Connect Program 15
How to Start a New Patient Exam 16

Using the Test Block 19
Preparing a Patient for Examination 20
Measurement Settings 20

How to Take a Patient Measurement 21
How to Perform a Calculation 21
How to Print or Save Report 24

Chapter 4: How to Navigate the Screens and Buttons 25

Overview 25
Main Tabs 25

Exams 25
Measurement 26
IOL Calculation 26
Setup 27

Chapter 5: Setting Up Personal Preferences 28

Overview 28
Setup Tab Selections 28

Options 29

Gain 40

Adjusting the Gain 40
Import /Export 41
Snapshots/ Reports 41
Facilities 45
Physicians 48
Users 49
Eye Types 51
Personalizing IOL Overview 58

Manual Entry of Personalization Information 62

Overview 62
Selecting IOL Group and Lens 62
Manual Entry of a Patient Record to be Personalized 63
Updating IOL Constant 64

Deleting Postoperative Results 64

Deleting Current Postoperative Result 64
Deleting All Postoperative Results 65
Save and Conrm Conguration Changes 65

Chapter 6: Entering Patient Information 66

Overview 66
Exam Tab 66

New A-scan Study 66
Control Unit Info 68
Study Info 68

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Table Of Contents

How to Start Exam 69

Recall Existing Patient 70
Selecting Existing Patient for Rescan 70
Selecting Rescan 71

Import Patient Information from Previously Saved
B-Scan Plus/ UBM Plus Information 71

Selecting Existing B-scan/ UBM Patient for Rescan 71

Delete Selected Exams Button 72
Refresh List 73

Select Folder 73

Exams Folder 73

Reset Exams Folder 73
Manage Version 4.0 Exams 73

Chapter 7: Measuring A Patient 74

Overview 74
Measurement Tab 74

Eye Type 75
Capture Method 76
Display Range 76
Gain 76
OD/OS 76
Rescan/Stop 76
Auto/Manual Capture 76
Auto Mode 77
Auto Restart 77
Using the Footswitch 77
Measurement Icons 78
How to Print a Record 78

Moving Gates 79

Overview 79
Available Gates/Threshold 80
Edit Gates of all Scan 81
Reset Gates 81

Chapter 8: Performing Calculations 82

Overview 82
Calculating the Lens 82

Calculation after Corneal Refractive Surgery 82

IOL Calculation Tab 82

Overview 82
Manage IOL Groups 84
Select IOL Groups 88
Selecting Formula 88
Changing the AXL Value 88
Entering K1 and K2 Values 89

Rx Surgery 90

Overview 90

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Accutome A-Scan Plus Connect Manual

Double K Method 91
Determining Corneal Power after Refractive Surgery 91
Post Rx Surg IOL Calculation Steps 91
Clinical History Method 92
Contact Lens Method 93
Shammas Clinical Method 93
Calculation Results 93
Formula Compare Feature 94
OD/OS 94
Printing Records 94

Chapter 9: Synergy Mode 95

Introduction 95
How to turn on Synergy mode 95

Network Folder or USB Disk Mode 96
IOLMaster 500 version 7.7 96

Chapter 10: Maintenance 100

General Maintenance 100

Safety Inspection 100
Visual Inspection 100
Ultrasound Inspection 100
Calibration of Accutome A-Scan Plus 100

Chapter 11: Specifications 101

Overview 101
Physical Specifications 101
Environmental Specifications 102
Measurement Accuracy 102
Computer Specification 102
Operating Modes 103
Formula References 104
Storage/Range Specifications 104
Acoustic Output 106
EMC Compliance Information 106

Chapter 12: Warranty and Repairs 109

Warranty 109
Product Returns 109

Service and Repair 109
All Other Returns 109
Non-returnable Merchandise 109

Replacement Parts 110
Documentation 110

Appendix 111

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vi

List Of Figures

Figure 1.1 - Accutome A-Scan Plus Connect 1
Table 3.1 - Personal Computer Specications 10
Figure 3.1 - Control Unit and Probe Connector (Right Side of Instrument) 11
Figure 3.3 - Accutome Ultrasonic Probe Kit (PN 24-4001) 12
Figure 3.2 - Probe Connected 12
Figure 3.4 - Accutome Probe 12
Figure 3.6 - Probe with Goldman Tonometer Adapter 13
Figure 3.7 - Inserting the Probe into the Handle Extension 13
Figure 3.5 - Probe Setup with Immersion Shell 13
Figure 3.8 - Probe with Handle Extension and Insertion Tool 14
Figure 3.9 - Probe with Handle Extension 14
Figure 3.10 - A-Scan Plus Connect Control Unit
Connect to a Laptop via USB Cable 14
Figure 3.10 - Accutome A-Scan Plus Connect Desktop Shortcut 15
Figure 3.11 - Main Screen Starting New Exam 16
Figure 3.12 - New A-scan Study Screen 16
Figure 3.13 - Entering New Patient Information 17
Figure 3.14 - Selection Facility 17
Figure 3.15 - Selection Physician. 18
Figure 3.16 - Selecting Operator 18
Figure 3.17 - Click Done Creating a New Exam 19
Figure 3.18 - Measurement Screen 19
Figure 3.21 - Measurement Screen Shown 20
Figure 3.19 - Measuring Test Block 20
Figure 3.22 - Measurement Done 21
Figure 3.23 - IOL Calculation Screen 22
Figure 3.24 - K1, K2 Values 23
Figure 3.25 - Calculation Complete 23
Figure 3.26 - Saving a Report 24
Figure 3.27 - Click Yes to Save 24
Figure 4.1 - A-Scan Plus Connect Exams Screen 25
Figure 4.2 - Measure Screen 26
Figure 4.3 - IOL Calculation Screen Selected 26
Figure 4.4 - Setup Screen Selected 27
Figure 5.2 - Select Setup Tab 28
Figure 5.1 - Desktop Icon 28
Figure 5.3 - Setup Tab Opened 29
Figure 5.4 - Option Screen 29
Figure 5.5 - Selecting Main Exam Folder 30
Figure 5.6 - Browse For Folder 30
Figure 5.7 - Selecting Save Changes 31
Figure 5.8 - Are You Sure 31
Figure 5.9 - User Select, Default Folder of Version 4.0 32
Figure 5.10 - Windows Browser - Locate Exam Folder 32

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Accutome A-Scan Plus Connect Manual

Figure 5.11 - Net Share 33
Figure 5.12 - Windows Browser - Locate Exam Folder 33
Figure 5.13 - Selecting Exam Name Combinations 34
Table 5.2 - Eye Types 34
Table 5.3 - Lens Materials and Velocities 35
Table 5.4 - Anterior/Vitreous Materials and Velocities 35
Figure 5.14 - Selecting the Default Eye Group 35
Figure 5.15 - Selecting the Default Formula 35
Figure 5.17 - Selecting Default Capture Mode 36
Figure 5.16 - Selecting Default Scan Method 36
Figure 5.18 - Selecting the K Index 38
Figure 5.19 - Selecting Save Changes 39
Figure 5.20 - Are You Sure 40
Figure 5.21 - Gain Adjustment Knob 40
Figure 5.22 - Turn On the Synergy Mode 41
Figure 5.23 - Selecting the Snapshot Format 42
Figure 5.24 - Snapshot Selection Completed 43
Figure 5.25 - Selecting Network Location 43
Figure 5.26 - Activating Export Report 44
Figure 5.27 - Selecting Network Location 45
Figure 5.28 - Successful Read Write Test 45
Figure 5.29 - Selecting “New” Facility 46
Figure 5.30 - Facility Information Being Entered 46
Figure 5.31 - Are You Sure 47
Figure 5.32 - Are You Sure 47
Figure 5-33 Physicians Screen 48
Figure 5.34 - Physician Name Entered 48
Figure 5.37 - Users Screen 49
Figure 5.35 - Are You Sure 49
Figure 5.36 - Are You Sure 49
Figure 5.38 - New User Information 50
Figure 5.39 - Are You Sure 50
Figure 5.40 - Are You Sure 50
Figure 5.42 - Additional Eye Types 51
Figure 5.41 - Are You Sure 51
Figure 5.44 - New Lens Material Window Activated 52
Figure 5.45 - New Lens Material Entered 52
Figure 5.43 - Eye Type Screen 52
Figure 5.46 - Are You Sure 52
Figure 5.48 - New Anterior/Vitreous Material Window Activated 53
Figure 5.47 - Are You Sure You Want to Remove 53
Figure 5.48 - New Anterior/Vitreous Material Window Activated 54
Figure 5.51 - Are You Sure You Want to Remove 54
Figure 5.52 - Are You Sure 54
Figure 5.50 - Are You Sure 54
Figure 5.53 - Creating a New Eye Type 55
Figure 5.54 - New Eye Type Window Opened, New Eye Type Name Entered 55
Figure 5.55 - Selecting Lens Material 55

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List Of Figures

Figure 5.56 - Entering Assumed Thickness 55
Figure 5.58 - Selecting the Vitreous Material 56
Figure 5.57 - Selecting the AC Material 56
Figure 5.59 - Are You Sure 56
Figure 5.60 - Create New Eye Type From Existing Eye Type 57
Figure 5.61 - New Eye Type Completed 57
Figure 5.62 - Are You Sure 57
Figure 5.63 - Are You Sure 58
Figure 5.64 - IOL Personalization 59
Figure 5.65 - Selecting IOL Group 59
Figure 5.66 - Selecting Lens to be Personalized 59
Figure 5.67 - Selecting the Formula 59
Figure 5.69 - Power of Lens Entered 60
Figure 5.68 - Files Transferred 60
Figure 5.70 - Power of Lens Entered 61
Figure 5.71 - Multiple Entries Completed 61
Figure 5.72 - Unlock IOL Groups 62
Figure 5.73 - Select Lens 62
Figure 5.74 - Selecting the Formula 62
Figure 5.75 - Select Manual Enter 63
Figure 5.76 - Manual Entry 63
Figure 5.77 - Selecting Save Changes 64
Figure 5.78 - Are You Sure 64
Figure 5.79 - Are You Sure 64
Figure 5.80 - Are You Sure 65
Figure 5.81 - Are You Sure 65
Figure 5.82 - Selecting Save Changes 65
Figure 5.83 - Are You Sure 65
Figure 6.2 - Create New A-scan Exam 66
Figure 6.1 - Selecting New Exam 66
Figure 6.3 - New A-Scan Study Screen 67
Figure 6.4 - Medical Record Number, Date Of Birth, and Gender Fields 68
Figure 6.5 - Control Unit Info 68
Figure 6.6 - Name Field 68
Figure 6.11 - Starting New Exam, Click Done 69
Figure 6.7 - Selecting Facility 69
Figure 6.8 - Selecting Physician 69
Figure 6.9 - Selecting Operator 69
Figure 6.10 - Entering Remark 69
Figure 6.12 - Measuremenr Screen 70
Figure 6.13 - Recalled Patient Record 70
Figure 6.15 - Rescan Are You Sure 71
Figure 6.16 - Exams Tab 71
Figure 6.14 - Select Rescan to Start Measurement 71
Figure 6.17 - Import B-scan Exam 72
Figure 6.18 - List of Saved B-Scans 72
Figure 6.19 - Selecting a Patient Record to Delete 72
Figure 6.20 - Are You Sure 73

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Accutome A-Scan Plus Connect Manual

Figure 6.22 - Manage Version 4.0 Section 73
Figure 6.21 - Select Folder Open 73
Figure 7.1 - Measurement Screen 75
Figure 7.2 - Select Eye Type 75
Figure 7.3 - Sclera and Retina Activated 77
Figure 7.4 - Measurement Reports 79
Figure 7.5 - Calculation Reports 79
Figure 7.6 - Gates 80
Figure 7.7 - Reset Gates 81
Figure 8.1 - IOL Calculation Screen 83
Figure 8.2 - IOL Calculation Screen 83
Figure 8.4 - IOL Groups Screen Opened 84
Figure 8.3 - Manage IOL Groups Screen 84
Figure 8.5 - Select New IOL Group 85
Figure 8.6 - New IOL Group Selected 85
Figure 8.7 - Group Name Added 85
Figure 8.8 - Entering the Description of the Lens 85
Figure 8.9 - Entering A-Constant 86
Figure 8.10 - First Lens Entered 86
Figure 8.11 - Lens Group Completed and Locked 87
Figure 8.12 - Selecting Lens Group to be Removed 87
Figure 8.13 - Save Changes 88
Figure 8.14 - Selecting IOL Group 88
Figure 8.15 - Formula Selected 88
Figure 8.16 - K1 and K2, Target Fields 90
Figure 8.17 - Changed Rx Surg Field 92
Figure 8.18 - K-Post Formula Selection Window Open 92
Figure 8.19 - Post Rx on Completion of Contact Lens Method 93
Figure 8.20 - Post Rx on Completion of Shammas Method 93
Figure 8-21 Compare All Featured Turned On 94
Figure 8.22 - Print Icon 94
Figure 9.2 - Import/Export Screen 95
Figure 9.1 - Setup Screen 95
Figure 9-3 Import/Export Screen 97
Figure 9.4 - Export Icon 98
Table 11.1 - Accutome A-Scan Plus Control Unit Physical Specications 101
Table 11-2 Accutome A-Scan Plus Connect Physical Specications 101
Table 11.3 - Environmental Specications 102
Table 11.4 - Measurement Accuracy 102
Table 11.5 - Recommended Computer Specications 103
Table 11.6 - Operating Mode(s) 103
Table 11.7 - Formula References 104
Table 11.8 - Data Specications 104
Table 11.8 - Data Specications (Continued) 105
Table 11.9 - Data Specications 105
Table 11.10 - Acoustic Output Reporting Table for Track 1,
Non-Autoscanning Mode 106
Table 11.11 Acoustic Output Reporting Table for Track 1,

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Non-Autoscanning Mode 106
Table 5.6 - Guidance And Manufacturer’s Declaration

- Electromagnetic Emissions 107
Table 5.7 - Guidance And Manufacturer’s Declaration

- Electromagnetic Immunity 107
Table 5.8 - Guidance And Manufacturer’s Declaration

- Electromagnetic Immunity 108
Table 12.1 - Accutome Replacement Parts 110
Table A.1 - A-Scan Plus Connect System Messages 111
Table A.1 - A-Scan Plus Connect System Messages (Continued) 112

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Chapter 1: Introduction

Introduction

1

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

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Accutome A-Scan Plus Connect Manual

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 efcient manufacturing provide scal 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

• Predened Eye Types and Velocities handle most situations such as phakic,
dense cataract, three types of pseudo-phakic, aphakic, silicone oil lled, 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 xation light
and multiple mounting options

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,

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2

Introduction

type, manufacturer, etc.

• Personalization of IOL Constants is easy and straightforward, encouraging
improved patient outcomes

• Maintains individual IOL Constants for each formula. Clearly identies 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 simplies the use of the Accutome
A-Scan Plus Connect:

• Immersion Shell

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.

Chapter 7 - Measuring Patient

Describes how to measure an eye.

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Accutome A-Scan Plus Connect Manual

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 specications.

Chapter 12 - Warranty and Repair

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

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Chapter 2: Safety

Safety

2

Safety Information

The section lists:

• Safety Precautions associated with the Accutome A-Scan Plus Connect

• Safety Precautions of a general nature

Federal law restricts this device to sale by or on the order of a physician.

Safety Issues to Consider When Using the Accutome A-Scan Plus
Connect

This instrument has no user operated controls or settings that affect the acoustic
output. The Accutome A-Scan Plus Connect is noninvasive. The ultrasonic biometry
probe touches the surface of the anesthetized cornea during the scanning process.
Energy in the form of ultrasound is transmitted into the eye. The maximum power
allowed to be set by the application software and or by the user is below the FDA,
HEALTH CANADA and EU maximum power limits.

Indications for use

This instrument is used for measuring the axial length, anterior chamber depth and
lens thickness of the eye. It also is used for calculating the optical power of the IOL
to be implanted during cataract surgery.

Side Effects

There are no known side effects associated with the use of A-scan ultra sound
imaging.
Any side effects associated with the use of the Accutome A-scan Plus Connect are
related to the topical anesthetic chosen by the physician, used to anesthetize the
eye of the patient.
Please consult the warning label of the chosen topical anesthetic for further
information.

Contraindications

There are no known contraindications associated with the use of the A-scan Plus
Connect.

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Accutome A-Scan Plus Connect Manual

Symbol Definitions for the Accutome A-Scan Plus Connect

Statements, graphics and symbols listed below are used on components of the
Accutome A-Scan Plus Connect. Descriptions and meanings are listed to the right
of the symbols.

Disinfection and Cleaning

Disinfection issues are conned to
the Accutome probe that comes
in contact with the patient’s eye. In
order to prevent the transmission
of disease, refer to the OSHA and
CDC guidelines for proper control
of disinfection. These guidelines
are frequently updated so be
sure to contact OSHA, CDC, or
your local disease control for the
latest information and disinfection
technique.
Accessories such as the extension
handle or Goldman Tonometer
Adapter which might come in
contact with eye uids should be
cleaned with an FDA cleared high
level disinfectant.
The probe must be cleaned between
patients to prevent patient-to­patient transfer of infection. It is
the user’s responsibility to ensure
that the relevant standards are
maintained and that the products
and procedures are effective
and appropriate for ophthalmic
applications. The following
information is provided for the
guidance of users, and specic
products are mentioned for illustration only. Accutome does not endorse the use
of these or any other product. Products must be used in accordance with the
manufacturer’s instructions.

Symbol Definitions for the

A-Scan Plus Connect

Attention! Consult
Instruction Manual

Type BF Medical

Device

No User
Serviceable Parts

Do Not Use
Near Flammable
Gasses

USB Connector

Disposal of Product
within the EU

Safety Precautions

There are several areas in the use of the above Accutome products that require
special attention, as they may pose a safety threat.

DO NOT AUTOCLAVE THE PROBES OR CONNECTORS.

DO NOT IMMERSE THE PROBE’S CABLES OR METAL CONNECTORS. ALLOW TO DRY
BEFORE USE.

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Safety

DO NOT IMMERSE THE PROBE TIPS IN TAP WATER. USE DISTILLED WATER FOR
CLEANING AND DISINFECTION

Cleaning Procedure at Point of Use

1. Wear protective gloves when performing the cleaning process.

2. Disconnect the probe from the system.

3. Use a soft cloth lightly dampened in a mild soap or compatible cleaning

solution to remove any particulate matter or body uids that remain on the
probe or cable.

4. To remove remaining particulates, rinse with a distilled water-dampened

cloth to remove soap residue, and then wipe with a dry cloth.

Disinfection of the Probes with Alcohol

One recommended disinfection technique is to clean the probe assemblies with
70% isopropyl alcohol.
A 5-10 minute exposure is recommended. It is imperative that the alcohol be given
to time to evaporate before applying a probe to that patient’s eye. Do not completely
immerse the probe or cable, only the tip of the probe should be placed in the
solution.
After cleaning, rinse the end of the probe thoroughly with distilled water to remove
all traces of the liquid used. Probe surfaces should be dried with a lint-free cloth.

High- Level Disinfection of the Probe

If high level disinfection is required by your facility, the probe may be cleaned using
an FDA cleared high level disinfectant, such as Cidex® OPA Activated Dialdehyde
Solution. If your facility is located in the EU, Mikrozid wipes are a compatible method
of high-level disinfection for Accutome probes.

Note: Be sure to follow the disinfectant manufacturer’s written protocol when
using any antibacterial solution, including high level disinfectants.

WARNING!! DO NOT AUTOCLAVE the probe, probe cable, or any other parts of the A-Scan
Plus Connect product.

WARNING!! DO NOT IMMERSE THE PROBE’S CABLE OR METAL CONNECTOR. ALLOW probe
TO DRY BEFORE USE.

CAUTION: General indications for use of the Accutome probe include external, structurally
intact areas of the eye globe and orbit areas only.

Electrical Hazard and Safety

The instrument, footswitch and probe of the Accutome A-Scan Plus Connect
are electrical/electronic devices. The A-Scan Plus Connect control unit is a
USB powered device. Reasonable care should be taken when making electrical
connection and handling electrically powered devices. Avoid use of damaged
electrical equipment or frayed electrical cords. If repair or maintenance is being
performed on the Accutome A-scan Plus Connect, the equipment must be turned
off and the power cord disconnected.

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Accutome A-Scan Plus Connect Manual

Covers must not be removed except by qualied personnel. To avoid injury, do not
operate the Accutome A-scan Plus Connect without protective covers.
Use only Accutome provided probe, footswitch and USB cable (connection between
Control Unit and laptop PC). Also, be sure the cable and connectors are in good
condition. Inspect the probe before each use to ensure that there are no breaks,
cracks, or other damage.

WARNING! THE A-Scan Plus Connect IS ONLY TO BE USED WITH A COMPUTER USING
MEDICAL GRADE POWER SUPPLY COMPLIANT with IEC60601-1

Please refer to the manufacturer’s instructions regarding its use.
The User is responsible for ensuring that the PC to which the
A-Scan Plus Connect system is connected must be of the grounding type in
compliance with applicable electrical codes.
To avoid interruption of a procedure, the user is responsible for ensuring that all
power and USB connections are secure and that the laptop is fully charged.

CAUTION: To avoid possible loss of patient data stored in the PC, ensure that the data is
backed up on some device external to the PC.

CAUTION: The A connector type, Version 1.1 USB ports on the Control Unit should be used
only for low power devices such as the footswitch, a memory “stick”, or a mouse.

Avoiding Equipment Damage

The Accutome A-Scan Plus Connect provides no explosion protection from static
discharge or arcing components. Do not operate the instrument in the presence of
explosive gases such as ammable mixtures of anesthetic and air, or nitrous oxide.
CAUTION: This Device is intended for use in a controlled environment only; it is not
intended for outdoor use.

Warning: Operating or storing the device beyond the environmental ranges in the
Specifications Chapter may result in erroneous readings and/or premature failure of the
device.

Avoiding Electromagnetic and Other Interference

Do not use a cellular telephone and other devices not complying with EMC Class B
requirements, as its signals may cause the equipment to malfunction. The effect
of radio signals on medical devices is dependent on various factors and therefore
unpredictable.
To avoid electromagnetic interference, the device must be installed and put into
operation in accordance with the user manual and using the components supplied
by Accutome.

Warning!! the use of accessories, transducers and cables other than those specified by the
manufacturer may result in increased emissions or decreased immunity of the a-scan plus
connect.

Warning!! the a-scan plus connect should not be used adjacent to or stacked with other
equipment and that if adjacent or stacked use is necessary, the a-scan plus connect
should be observed to verify normal operation in the configuration in which it will be used.

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8

Getting Started

Chapter 3: Getting Started

Getting Started

3

Assembling the Accutome A-Scan Plus Connect

The Accutome A-Scan Plus Connect measures the axial length of the eye and
calculates the power of the intraocular lens.
The product consists of an A-Scan Plus Connect Control Unit, 10 MHz composite
a-probe, a USB foot switch, USB Cable (A-B type), test block, quick reference/
installation guide and a CD containing the Accutome A-Scan Plus Connect
software, all in a plastic carrying case.
The user supplies a windows based personal computer with Microsoft XP service
pack 2 or higher.
The Accutome A-Scan Plus Connect is designed to be used in multiple
environments and is as simple as carrying a notebook computer and probe. The
instrument requires virtually no assembly. You simply install the software and plug
the USB Control Unit with probe into your computers USB port. The USB foot switch
can either be plugged in the A-Scan Plus Connect Control Unit or any unused USB
port in the computer.

What you Need

For a complete Accutome A-Scan Plus Connect environment you will need the
following:

• Windows based Personal Computer

• Windows based XP SP2 or newer

• Intel Core 2 Duo (2.40GHz or higher)

• 4M L2 Cache, 66MHz

• 4 USB ports version 2.0

• Accutome A-Scan Plus Connect Control Unit

• Accutome A-Scan Plus Connect 10MHz composite probe

• USB Footswitch

• Accutome A-Scan Plus Connect software

• A-B type USB cable (Control Unit to laptop computer)

• Printer (to print out reports)

Note: It is recommended that the PC be compliant with IEC 60601-1 and IEC
60601-1-2.

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Accutome A-Scan Plus Connect Manual

Personal Computer Specifications

Table 3.1 - Personal Computer Specications

PC

I/O Ports Minimum 3 USB 2.0

Operating Systems Windows® XP Professional, SP2 or newer

Display 15.4 inch WSXGA + LCD or larger

Memory 2.0 GB, DDR2-667 SDRAM

Hard Disk Drive 80 GB, Hard Disk Drive, 9.5 MM, 7200 RPM

CD/DVD Drive 8X DVD+/-RW w/Roxio Software™ and Cyberlink Power DVD

Video Controller 256 MB NVIDIA® Quadro NVS 100M TurboCache™

Windows based PC, with Intel Duo (2.40 GHz) 4M L2 Cache,
667 MHz Dual Core or higher

A-Scan Plus Connect Control Unit

The A-Scan Plus Connect Control Unit connects the A-probe to the computer. The
Control Unit contains all the ports that connect the Control Unit to the computer,
the analog to digital amplier electronics, external gain control, A-probe connection
and three (versions 1.1) USB ports, which may be used for foot switch and mouse.

CAUTION: The A connector type, Version 1.1 USB ports on the Control Unit should be used
only for low power devices such as the footswitch, a memory “stick”, or a mouse.

A-Scan Plus Connect 10MHz Composite A-Probe

The A-probe included with A-Scan Plus Connect is an essential component. No
other probes should be used with the system unless authorized by Accutome Inc.

USB Foot Switch

The foot switch is used to stop, start and review the axial length
measurements.

A-B Type USB Cable (Control Unit to Computer)

A USB cable is provided to connect the A-Scan Plus Connect Control Unit to the
computer.

Printer

In order to print out the measurements and the IOL calculations, you will need a
local or network printer attached to the PC.

Accutome A-Scan Plus Connect Software

The software for the Accutome A-Scan Plus Connect is provided on a CD or can be
found on Accutome’s Support site at support.accutome.com.

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10

Getting Started

Assembling the A-Scan Plus Connect

CAUTION: Do not connect the A-Scan Plus Connect to the computer until the software has
been loaded and instructed to do so.

Assemble the personal computer according to the manufacturer’s instructions.
Connect the printer according to the manufacturer’s instructions.

Connecting the Probe

The Accutome A-Scan Plus Connect probe connector is located on the right side of
the instrument (facing the instrument).
To connect the probe:

1. Locate the probe connector, which is located on the right side of the control

unit (see Figure 3.1 below.)

Control Unit

Probe Connector

Figure 3.1 - Control Unit and Probe Connector (Right Side of Instrument)

2. The probe connector is keyed and has a red dot indicating the key.

3. Insert the probe with the red dot facing the back of the instrument. (Refer

to Figure 3.2 on next page.)

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Accutome A-Scan Plus Connect Manual

Probe Setup

The Accutome A-Scan Plus Connect
probe is an integral component. There are
several options available for probe use. The
Accutome A-Scan Plus Connect probe can
be used:

1. With an immersion shell

2. Mounted into a Goldman Tonometer

3. With a probe handle extension

4. Freehand

Probe

Note: You cannot operate the Accutome
A-Scan Plus Connect without the

Figure 3.2 - Probe Connected

Accutome probe.

Probe Connector

Extension Handle Insertion Tool

Extension Handle

Goldman Tonometer
Adapter

Accutome Probe

Figure 3.3 - Accutome Ultrasonic Probe Kit (PN 24-4001)

Accutome Ultrasonic Probe Kit (PN 24-4001)

The Accutome probe is designed to be
used with an Immersion Shell. When
using an immersion shell ensure that
there is minimum a distance of 5mm
between the bottom of the probe and
the bottom of the immersion shell, as
shown in Figure 3.5 on next page.

Figure 3.4 - Accutome Probe

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Accutome Probe with Goldman
Tonometer Adapter

The Accutome probe is designed to be
used with a Goldman Tonometer Adapter.
When using the Tonometer Adapter:

1. Slide the adapter over the end of

the probe as shown in Figure 3.6
below.

2. Mount the probe by inserting

the adapter into the Goldman
Tonometer.

Getting Started

Immersion Shell

Probe does not
go further then
this line

Shell Bottom

Goldman Tonometer
Adapter

Figure 3.5 - Probe Setup
with Immersion Shell

Probe

Figure 3.6 - Probe with Goldman Tonometer Adapter

Accutome Probe with Handle Extension

The Accutome probe is designed to be used with a handle extension to
increase the length of the probe. When using the probe handle extension:

1. Insert the probe into the handle extension as shown in Figure 3.7 below.

2. Slide the insertion tool into the handle extension making sure that the

probe cable runs through the notched channel of the insertion tool.

3. Push the probe through the handle extension until the tip of the probe

emerges from the extension.

4. Remove the insertion tool by sliding it back away from the handle extension.

Insertion Tool

Probe

Handle Extension

Probe Cable

Removing
Insertion Tool

Probe inside Handle Extension

Figure 3.7 - Inserting the Probe into the Handle Extension

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Accutome A-Scan Plus Connect Manual

Figure 3.8 - Probe with Handle Extension and Insertion Tool

Figure 3.9 - Probe with Handle Extension

Figure 3.10 - A-Scan Plus Connect Control Unit Connect to a Laptop via USB Cable

Connecting the A-Scan Plus Connect to the Computer

Connect the foot switch to either an unused USB port located with in the
computer or the A-Scan Plus Connect Control Unit.
Connect the receiver of the mouse to an unused USB port located within the
A-Scan Plus Connect Control Unit.

Installation of the Software

Please see the A-Scan Plus Connect Installation Instructions for all Windows

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14

Getting Started

operating systems, which are included in the carrying case.
Connect the A-Scan Plus Connect Control Unit to the computer via USB cable.
A red indicator on the A-Scan Plus Connect Control Unit indicates that the Control
Unit is powered up by the PC but Windows operation system (OS) is not seeing the
Control Unit. If the Windows device driver was installed correctly, it will change to
either yellow or green.
A green indicator on the A-Scan Plus Connect Control Unit indicates that the
Accutome A-Scan Plus Connect is installed correctly and ready to measure
patients.
A yellow indicator on the A-Scan Plus Connect Control Unit indicates that the
A-Scan probe is not connected to the A-scan Plus Connect.
During normal operation, every time the Control Unit is powered up the indicator
will turn red at rst, then turn to green or yellow. A continuous red (more than 3
seconds) means the device driver is not installed correctly.

Note: Please see table A-1 in the appendix for resolving the problem of a red and
yellow indicator.

The Control Unit will be powered on immediately after being plugged into a PC and
stay on until it is unplugged. To turn it off, just unplug the USB cable from the PC.
The A-Scan Plus Connect software application is fully functioning even without the
Control Unit. The only limitation is not being able to take new scans.

Basic Operation

The basic operation of the Accutome A-Scan Plus Connect consists of the following
steps:

1. Turn on computer.

2. Connect the control unit.

3. Start the Accutome program. Refer to “Starting the A-Scan Plus Connect

Program.”

4. Start a “New Exam.” Refer to “How to Start a New Exam.”

5. Enter patient information. Refer to “How to Enter Patient Information.”

6. Take five measurements per eye.

7. Calculate the IOL power for desired results.

8. Print or save the Patient Record

Starting Accutome A-Scan Plus Connect Program

The Accutome A-Scan Plus Connect program is launched like any other Windows
program, either through a shortcut on the desktop or by accessing the “Start”
programs menu.
If launching the A-Scan Plus Connect software from the desktop, click on the
icon displayed below. The A-Scan Plus Connect software will display at the Exams
screen, see gure 3.11.

Figure 3.10 - Accutome A-Scan Plus Connect Desktop Shortcut

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Accutome A-Scan Plus Connect Manual

How to Start a New Patient Exam

To start a new Patient exam:

1. On the Accutome Exam Screen, click on “New.” Refer to Figure 3.11 below.

Figure 3.11 - Main Screen Starting New Exam

Entering Patient Exam Information

After you execute “New” from the Accutome A-Scan Plus Connect Exams screen,
the New A-Scan Study screen will launch as shown in Figure 3.12. The pre-lled
information elds are from the setup defaults.

1. When you start a new exam the Accutome A-Scan Plus Connect will launch
the New A-scan Study Screen shown in Figure 3.12 and will clear all patient
info elds.

Note: The Patient/Exam Info Screen contains drop down lists that are created
during A-Scan Plus Connect setup. Refer to the Setup chapter for further
information.

Figure 3.12 - New A-scan Study Screen

2. Enter information in data elds by left clicking in each eld and typing
accordingly. In Figure 3-13 below the Last Name eld has just been
completed.

To move from one eld to another you may use the Tab Key on your computer
keyboard or simply click on the eld.

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16

Getting Started

Figure 3.13 - Entering New Patient Information

3. The Patient Info must be entered to proceed to the next screen. Select the
First Name eld and enter the Patient First Name.

4. Use the Tab key, or select the Last Name eld and enter the Patient Last
Name.

5. Continue entering all relevant patient information.

6. If you wish to select a Facility, select one from the predened (in A-Scan
Plus Connect Setup) facility drop down list. Position the cursor on the small
arrow at the right of the facility eld. Left click to open the drop down list.
Position the mouse over the up/down arrows at the right of the drop down
list Click the mouse to move through stored facilities. Once you see the
facility you want to select, position the mouse cursor over the facility and
left click. The selected facility will ll in the facility eld.

Figure 3.14 - Selection Facility

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Accutome A-Scan Plus Connect Manual

7. Continue to select Physician and Operator from the drop down lists located
at the right side of the each eld. Position the cursor on the small arrow at
the right of the physician and operators elds. Left click to open the drop
down list. Position the mouse over the up/down arrows at the right of the
drop down list. Click the mouse to move through stored physicians and
operators. Once you see the Physician and Operators you want to select,
position the mouse cursor over the Physician and Operator and left click.
The selected Physician and Operator will ll in the Physician and Operator
eld.

Figure 3.15 - Selection Physician.

Figure 3.16 - Selecting Operator

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18

8. Click on the “Done” button, located at the bottom right of the New

A-scan Study Screen.

Figure 3.17 - Click Done Creating a New Exam

9. The A-Scan Plus Connect will launch the Exam Screen shown below.

Getting Started

Figure 3.18 - Measurement Screen

Using the Test Block

The Accutome A-Scan Plus Connect comes with a test block included as an
accessory. Refer to the gure below. The test block is provided as a convenient way
to test the functionality of the instrument and probe.

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19