DGH TECHNOLOGY Scanmate A Manuel utilisateur

Page 1 of 89 6000-INS-OMENG Rev. 5

DGH 6000 (SCANMATE-A)

ULTRASONIC A-SCAN

Scanmate

DGH 6000

OPERATOR’S MANUAL

For Use with Scanmate Software v4.2

Equipment Manufactured By Authorized Representative

0120

Molenstraat 15

2513 BH, The Hague

The Netherlands

Phone: +31.70.345.8570

EC REP

EMERGO EUROPEDGH TECHNOLOGY, INC.

110 SUMMIT DRIVE

SUITE B

EXTON, PA 19341

USA (610) 594-9100

Molenstraat 15

2513 BH, The Hague

The Netherlands

Phone: +31.70.345.8570

EC REP

EMERGO EUROPEDGH TECHNOLOGY, INC.

110 SUMMIT DR IVE

SUITE B

EXTON, PA 19341

USA (610) 594-9100

Prinsessegracht 20

2514 AP, The Hague

The Netherlands

Molenstraat 15

2513 BH, The H ag ue

The Netherlands

Phone: +31.70.345.8570

EC REP

EMERGO EUROPEDGH TECHNOLOGY, INC.

110 SUMMIT DRIVE

SUITE B

EXTON, PA 19341

USA (610) 594-9100

Page 2 of 89 6000-INS-OMENG Rev. 5

This page intentionally left blank.

 
Page 3 of 89 6000-INS-OMENG Rev. 5 
TABLE OF CONTENTS 
 
1GENERAL DEVICE DESCRIPTION................................................................................6 
2DEVICE CLASSIFICATION.............................................................................................7 
3INDICATIONS FOR USE..................................................................................................7 
4WARNINGS AND CAUTIONS ........................................................................................7 
1 Meaning of Signal Words................................................................................7 
2 Device Labels ..................................................................................................8 
3 Description of Symbols ...................................................................................8 
4 General Cautions and Warnings......................................................................9 
5PRESCRIPTION DEVICE STATEMENT ......................................................................11 
6OPERATOR QUALIFICATIONS ...................................................................................11 
7USE OF ULTRASOUND IN OPHTHALMIC MEASUREMENTS...............................11 
1 Introduction to Ultrasound.............................................................................11 
2 Using Ultrasonic Signals to Ascertain Correct Probe Alignment.................12 
3 Ultrasonic Measurement................................................................................14 
8ULTRASONIC EXPOSURE AND INTENSITIES.........................................................16 
1 Tissue Exposure to Ultrasound Energy .........................................................16 
2 Ultrasonic Intensities .....................................................................................16 
9BIOMETRIC MEASUREMENT CAPABILITIES..........................................................17 
INSTALLATION AND CONFIGURATION OF SCANMATE SOFTWARE...............17 
STARTING THE SCANMATE SOFTWARE.................................................................17 
1 Launching the Application.............................................................................17 
2 Splash Screen.................................................................................................17 
3 Login Screen..................................................................................................18 
4 No USB Devices Detected Warning..............................................................18 
5 Touch Controls ..............................................................................................18 
CONFIGURING THE SCANMATE SOFTWARE.........................................................19 
1 System Preferences........................................................................................19 
2 Operator Preferences......................................................................................21 
3 A-Scan Page Preferences...............................................................................23 
4 Doctor Preferences.........................................................................................23 
5 Configuring Custom Velocities.....................................................................26 
6 Adding IOLs to the Database.........................................................................27 
7 Personalizing Lens Constants........................................................................29 
7.1 Overview...............................................................................................30 
7.2 Procedure..............................................................................................31 
THE PATIENT DATA SCREEN.....................................................................................34 
1 Patient Data Screen Controls.........................................................................34 
2 Entering a New Patient ..................................................................................35 
3 Searching for a Patient...................................................................................36 
4 Editing a Patient Record ................................................................................ 36 
5 Creating a New Procedure.............................................................................37 
6 Entering Pre-Operative Data..........................................................................37 
7 Entering Post-Operative Data........................................................................37 
THE A-SCAN SCREEN...................................................................................................39 
1 Selecting the Operator ...................................................................................39 

 
Page 4 of 89 6000-INS-OMENG Rev. 5 
2 Selecting the Lens and Vitreous Type...........................................................39 
3 Selecting OD or OS .......................................................................................40 
4 Measurement Modes......................................................................................40 
5 Automatic Measurement Mode .....................................................................40 
6 Manual Measurement Mode..........................................................................41 
7 Selecting Immersion or Contact Measurement Modes..................................43 
8 Setting the Corneal Compression Lockout Sensitivity..................................43 
9 Performing a Contact Measurement ..............................................................44 
10 Performing an Immersion Measurement .......................................................49 
11 Saving a Measurement File............................................................................54 
12 Saving a Video Buffer ...................................................................................54 
13 Reviewing Measurements and Videos...........................................................54 
14 Voice Controls...............................................................................................55 
THE B-SCAN SCREEN...................................................................................................56 
THE IOL CALCULATOR SCREEN (OPTIONAL FEATURE).....................................57 
1 IOL Calculator Screen Controls ....................................................................58 
2 Patient Information ........................................................................................58 
3 Selecting the Doctor.......................................................................................58 
4 Eye Selection .................................................................................................58 
5 Post Refractive Selection...............................................................................59 
6 Measurement Source.....................................................................................59 
7 Corneal Refractive Index...............................................................................59 
8 Corneal Power (K1 and K2) ..........................................................................60 
9 Desired Refraction.........................................................................................60 
10 Selecting IOLs ...............................................................................................60 
11 Selecting IOL Power Calculation Formulas..................................................60 
12 Selecting Personalized Lens Constants.......................................................... 61 
13 K Correction Method Selection.....................................................................61 
14 IOL Calculator Outputs .................................................................................61 
15 Saving Pre-Operative Data ............................................................................61 
16 Post Refractive Calculation Methods ............................................................62 
17 Using the Post Refractive Calculator.............................................................65 
18 Performing IOL Calculations.........................................................................66 
19 Overview of IOL Power Calculation Formulas.............................................68 
20 Factors Impacting the Accuracy of IOL Power Calculations........................69 
20.1 Axial Length.........................................................................................69 
20.2 Corneal Power.......................................................................................69 
20.3 Postoperative Anterior Chamber Depth................................................70 
20.4 Surgical Technique ...............................................................................70 
20.5 Implant Power.......................................................................................70 
CREATING REPORTS....................................................................................................71 
1 IOL Calculator Report...................................................................................71 
2 A-Scan Short Report......................................................................................71 
3 A-Scan Custom Report..................................................................................71 
4 AXL Progression Report ...............................................................................71 
5 Using Reports ................................................................................................72 
6 Opening Reports ............................................................................................72 

 
Page 5 of 89 6000-INS-OMENG Rev. 5 
7 Exporting A-Scan PDF Reports.....................................................................72 
DATABASE MANAGEMENT........................................................................................73 
1 Importing and Exporting Data.......................................................................73 
ELECTROMAGNETIC COMPATIBILITY....................................................................74 
CARE AND MAINTENANCE........................................................................................76 
1 Care of Transducer.........................................................................................76 
2 Cleaning and Disinfecting the Transducer Tip..............................................77 
3 Cleaning and Disinfecting the Immersion Shell............................................79 
4 Care of USB Interface Module......................................................................80 
5 Cleaning the USB Interface Module..............................................................80 
6 Operating Conditions.....................................................................................80 
7 Verifying A-Scan Calibration........................................................................80 
8 Storage...........................................................................................................81 
9 Transportation................................................................................................81 
10 Disposal .........................................................................................................82 
TROUBLESHOOTING....................................................................................................82 
1 Unable to Get a Measurement .......................................................................82 
WARRANTY....................................................................................................................83 
LIFETIME / SHELF-LIFE................................................................................................83 
CUSTOMER SERVICE ...................................................................................................84 
APPENDIX A COMPUTER SYSTEM SPECIFICATIONS...............................................85 
APPENDIX B SCANMATE-A SPECIFICATIONS ...........................................................86 
APPENDIX C REFERENCES .............................................................................................87 
APPENDIX D TERMS AND ABBREVIATIONS..............................................................89 

Page 6 of 89 6000-INS-OMENG Rev. 5

1General Device Description

The DGH 6000 is a diagnostic ultrasound device used by professionals in the

ophthalmic field to perform axial length (AXL), anterior chamber depth (ACD), and

lens thickness (LT) measurements of the human eye. Measurements are obtained using

ultrasonic pulse echo technology, whereby short bursts of ultrasonic energy are

transmitted and the resulting echoes are captured, amplified, filtered and processed.

The DGH 6000 is comprised of three main components: a detachable 10-MHz

transducer, a USB interface module and the Scanmate software application.

The transducer uses a single element piezoceramic with a starting frequency of 12.5

MHz +/- 1.25 MHz. This ceramic, after it has been damped, runs at a center frequency

of 10.0 MHz nominal. The tip of the transducer has a spherical radius of curvature,

which focuses the acoustic beam at 23.0 mm nominal. It is also equipped with a fixation

LED to facilitate probe alignment.

The USB Interface Module contains the electronics used to pulse the transducer as well

as to measure, filter and amplify the resulting echoes from internal eye structures. The

USB Interface Module is powered and controlled via a USB 2.0 cable, which must be

connected to a PC or laptop computer running the Scanmate software application.

The Scanmate software interprets the digital signals transmitted by the USB Interface

Module and displays a live “Amplitude Scan” which shows the relative magnitude and

distance of the echo spikes received by the transducer. Specific time distances between

the captured echo spikes are then measured and converted into distance information. A

digital signal processing algorithm is used to analyze the waveform, ensuring that the

probe is properly aligned at the time of measurement. The software assists the user in

performing replacement IOL power calculations using established formulas. The user

can save videos or measurement files or create reports to document the results of the

exam.

The captured A-Scan waveforms, associated measurements, and IOL calculations should

be evaluated only by trained medical personnel. The DGH 6000 does not conduct nor

provide any diagnoses, drive therapeutic outputs, or determine or maintain any life

sustaining or life threatening equipment.

Page 7 of 89 6000-INS-OMENG Rev. 5

2Device Classification

Device: System, Imaging, Pulsed Echo, Ultrasonic

Panel: Radiology

Product Code: IYO

Device Class: II

Regulation Number: 21 CFR 892.1560

Device: Diagnostic Ultrasonic Transducer

Panel: Radiology

Product Code: ITX

Device Class: II

Regulation Number: 21 CFR 892.1570

3Indications for Use

The intended use of the DGH 6000 is the measurement of axial length, anterior chamber

depth, and lens thickness of the human eye. The DGH 6000 is also intended to calculate

the optical power of an IOL that is to be implanted during cataract surgery. The DGH

6000 is intended to be used solely by qualified medical professionals. Clinical

consideration and judgment should be applied when using the DGH 6000.

4Warnings and Cautions

4.1 Meaning of Signal Words

In this manual, the signal words “Warning” and “Caution” are used to highlight

important safety and usage instructions. All users of the DGH 6000 must understand the

meanings of these signal words.

Signal Word

Meaning

! WARNING

Indicates a potentially hazardous situation which if not

avoided could cause injury or harm to the equipment or

erroneous results.

! CAUTION

Indicates a potentially hazardous situation which if not

avoided may result in minor injury or harm to the

equipment.

Page 8 of 89 6000-INS-OMENG Rev. 5

4.2 Device Labels

The label shown below is located on the underside of the USB Interface Module.

4.3 Description of Symbols

This symbol indicates the degree of protection against electric shock. The

DGH 6000 Scanmate-A is classified as type BF equipment.

This symbol indicates that the DGH 6000 Scanmate-A is an IEC Protection

Class II (double insulated) device.

This symbol instructs the operator to read the operating manual.

This mark indicates that Notified Body 0120 (SGS United Kingdom Ltd)

has certified the management system of DGH Technology, Inc. meets the

requirements applicable requirements of 21 CFR 1010 (Performance

Standards for Electronic Products: General) and 21 CFR 1050 (Performance

Standards for Sonic, Infrasonic, and Ultrasonic Radiation-Emitting

Products). The device also conforms to the following International

Standards:

▪EN 60601-1: Medical electrical equipment –Part 1: General

requirements for safety –IEC 60601-1

▪EN 60601-1-2: Medical electrical equipment –Part 1: General

requirements for safety. Collateral standard: Electromagnetic

compatibility requirements and tests. IEC 60601-1-2

▪NEMA Standard Publication UD-2: Acoustic Output Measurement

Standard for Diagnostic Ultrasound Equipment

▪NEMA Standard Publication UD-3: Standard for Real-Time Display

of Thermal and Mechanical Acoustic Output Indices on Diagnostic

Ultrasound Equipment

0120

Page 9 of 89 6000-INS-OMENG Rev. 5

This symbol indicates that Emergo Europe is the European Authorized

Representative for this device.

This symbol indicates that DGH Technology, Inc. is the manufacturer of the

DGH 6000 Scanmate-A device. The YYYY under the symbol indicates the

year the device was manufactured.

This symbol indicates that the model number of this device is DGH 6000.

This symbol indicates the serial number of the device. YYYY indicates

the year of manufacture and XXXX indicates the unit number.

This symbol located on the DGH 6000 indicates that the equipment consists

of electronic assemblies and other components that may be subject to

Directives 2002/96/EC, 2003/108/EC, and 2002/95/EC of the European

parliament, which advises that electrical and electronic devices must not be

disposed of as normal domestic refuse. In order to prevent environmental

risks or endangerments by non-professional disposal, the disposal of this

product, including any accessories, must comply with valid practices as

outlined in Directives 2002/96/EC, 2003/108/EC, and 2002/95/EC and local

regulations. All electronic components and systems should be returned to

Original Manufacturer for disposal.

4.4 General Cautions and Warnings

! CAUTION

The probe must be cleaned after each use. Cleaning the probe is an essential step

prior to effective disinfection. Follow the manufacturer’s instructions when using

disinfectants.

! WARNING

Equipment not suitable for use in the presence of flammable mixtures.

! WARNING

Do not allow sharp objects, such as scalpels or cauterizing knives, to touch the

transducer or cables.

EC REP

yyyy

REF

Page 10 of 89 6000-INS-OMENG Rev. 5

! WARNING

If the device is used in conjunction with other devices, current leakage may

increase and electric shock may be caused. It is the user’s responsibility to ensure

safety when the device is to be used in conjunction with other devices. If safety

cannot be ensured, the simultaneous use of devices is not allowed.

! WARNING

The use of a “Non-Medical” grade AC Adapter could potentially cause harm to

the system, the probe, the operator and/or the patient.

! WARNING

Use of this equipment adjacent to or stacked with other equipment may result in

improper operation and should be avoided. If such use is necessary, all equipment

should be observed to verify normal operation.

! WARNING

Electromagnetic interference may cause distortion of received ultrasonic signals.

Such interference may result in distorted waveforms.

! WARNING

Use of accessories and cables other than those specified or provided by the

manufacturer of this equipment could result in increased electromagnetic

emissions or decreased electromagnetic immunity of this equipment and result in

improper operation.

Ce manuel convient aux modèles suivants

Table des matières

Autres manuels DGH TECHNOLOGY Équipement de diagnostic

DGH TECHNOLOGY

DGH TECHNOLOGY SCANMATE FLEX Manuel utilisateur

DGH TECHNOLOGY

DGH TECHNOLOGY PACHETTE 500 Manuel utilisateur

DGH TECHNOLOGY

DGH TECHNOLOGY Scanmate-B DGH 8000 Manuel utilisateur

Manuels Équipement de diagnostic populaires d'autres marques

Mindray

Mindray M7Vet Guide de démarrage rapide

Autel

Autel MaxiProgrammer 201 Manuel utilisateur

TEXA

TEXA TMD2 Manuel utilisateur

Autel

Autel MaxiIM IM608 Manuel utilisateur

Sealey

Sealey BT2012 Manuel utilisateur

Diagnoptics

Diagnoptics Age Reader Manuel utilisateur

LAUNCH TECH

LAUNCH TECH X-431 PRO5 Manuel utilisateur

Hella Gutmann

Hella Gutmann Mega macs X Manuel utilisateur

Foxwell

Foxwell I80TS Manuel utilisateur

KaVo

KaVo 3D eXam Manuel utilisateur

ATEQ

ATEQ VT46 Manuel utilisateur

Hella Gutmann

Hella Gutmann mega macs X Manuel utilisateur

Autel

Autel MaxiFlash VCMI Manuel utilisateur

Qiagen

Qiagen QIAcube Connect MDx Manuel utilisateur

Alber

Alber BDSU Manuel utilisateur

St. Jude Medical

St. Jude Medical QUANTIEN Manuel utilisateur

Bosch

Bosch DCU 100 Manuel utilisateur

Launch

Launch CNC-602A Manuel utilisateur