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 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 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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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
HighLevel 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 Confirm Configuration 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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List Of Figures

Figure 1.1 - Accutome A-Scan Plus Connect	1
Table 3.1 - Personal Computer Specifications	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 Specifications	101
Table 11-2 Accutome A-Scan Plus Connect Physical Specifications	101
Table 11.3 - Environmental Specifications	102
Table 11.4 - Measurement Accuracy	102
Table 11.5 - Recommended Computer Specifications	103
Table 11.6 - Operating Mode(s)	103
Table 11.7 - Formula References	104
Table 11.8 - Data Specifications	104
Table 11.8 - Data Specifications (Continued)	105
Table 11.9 - Data Specifications	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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1 Introduction

Accutome A-Scan Plus Connect Overview

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

Figure 1.1 - Accutome A-Scan Plus Connect

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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 efficient manufacturing provide fiscal value. Upgradable software protects your investment.

The A-Scan provides the following general features:

•Use on any Windows based computer

•Universal interface and probe

•Easily updated software

•Provides a variety of printouts

•Portable

Measurements

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

•High-resolution, real-time waveform display

•High-speed digitalization acquires over 4000 points per waveform

•Continuous display of Axial Length, ACD, Lens Thickness, and Vitreous dimensions

•Audible feedback of contact and capture

•Immersion mode yields improved accuracy - Contact mode also supported

•Automatically or Manually capture up to 5 waveforms for each eye

•Adjustable Gain, Velocities, Gates, and Amplitude Thresholds

•Modify all waveform parameters using real-time or frozen waveforms

•Predefined Eye Types and Velocities handle most situations such as phakic, dense cataract, three types of pseudo-phakic, aphakic, silicone oil filled, and even phakic ICL eyes. All velocities are fully adjustable

•Custom Eye Types and Material Velocities can be created to handle individual preferences, special pathologies, or future trends

•Highly sensitive 10MHz composite Broadband probe features a fixation light and multiple mounting options

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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Introduction

type, manufacturer, etc.

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

•Maintains individual IOL Constants for each formula. Clearly identifies which IOL constant is used with the selected formula

•IOL Calculation for Post Refractive Surgery Patients

Components

The components that are standard with each Accutome A-Scan Plus Connect instrument are:

•Ultrasonic probe

•Control Unit

•Footswitch

•Software CD which contains:

•User’s Guide

•System Software (to be loaded onto PC)

•A-B Type USB Cable

•Test Block

•Installation Instructions

•Quick Reference Guide

Optional Components

There is an additional component which further simplifies the use of the Accutome A-Scan Plus Connect:

• Immersion Shell

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 specifications.

Chapter 12 - Warranty and Repair

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

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2Safety

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 confined 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 fluids should be cleaned with an FDA cleared high level disinfectant.

The probe must be cleaned between patients to prevent patient-to- patient 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 specific

products are mentioned for illustration only of these or any other product. Products 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 fluids 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.

HighLevel 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 qualified 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 flammable 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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3 Getting Started

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 Specifications

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

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 amplifier 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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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

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

Probe

Figure 3.2 - Probe Connected

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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Getting Started

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.

Immersion Shell

Probe does not go further then this line

Shell Bottom

	Goldman Tonometer			Figure 3.5 - Probe Setup
				with Immersion Shell
	Adapter
	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.

Extension

Handle

	Insertion Tool
	Probe
	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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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 first, 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, figure 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-filled information fields 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 fields.

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 fields by left clicking in each field and typing accordingly. In Figure 3-13 below the Last Name field has just been completed.

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

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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 field and enter the Patient First Name.

4.Use the Tab key, or select the Last Name field 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 predefined (in A-Scan Plus Connect Setup) facility drop down list. Position the cursor on the small arrow at the right of the facility field. 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 fill in the facility field.

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 field. Position the cursor on the small arrow at the right of the physician and operators fields. 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 fill in the Physician and Operator field.

Figure 3.15 - Selection Physician.

Figure 3.16 - Selecting Operator

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Getting Started

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.

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 figure below. The test block is provided as a convenient way to test the functionality of the instrument and probe.

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