DGH TECHNOLOGY Scanmate A Operator's Manual

Ultrasonic a-scan

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Scanmate

For Use with Scanmate Software v4.2

Equipment Manufactured By

DGH TECHNOLOGY , INC.

110 SUMMIT DRIVE

SUITE B

EXTON, PA 1934 1

EXTO N, PA 1934 1

EXTON, PA 1934 1

USA (6 10) 594 -9100

Page 1 of 89

DGH 6000 (SCANMATE-A)

ULTRASONIC A-SCAN

DGH 6000

OPERATOR'S MANUAL

Authorized Representative

EMERGO EUROPE

Molenstraat 15

Prinsessegracht 20

REP

2513 BH, The H ag ue

REP

2514 AP, The Hague

2513 BH, The H ag ue

The Netherlands

Phone: +31.70.345.8570

6000-INS-OMENG Rev. 5

0120

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Page 1 ULTRASONIC A-SCAN Scanmate DGH 6000 OPERATOR’S MANUAL For Use with Scanmate Software v4.2 Equipment Manufactured By Authorized Representative DGH TECHNOLOGY , INC. DGH TECHNOLOGY , INC. EMERGO EUROPE EMERGO EUROPE DGH TECHNOLOGY , INC. EMERGO EUROPE 110 SUMMIT DRIVE 110 SUMMIT DRIVE...
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Page 3: Table Of Contents
TABLE OF CONTENTS GENERAL DEVICE DESCRIPTION................6 DEVICE CLASSIFICATION ..................... 7 INDICATIONS FOR USE ....................7 WARNINGS AND CAUTIONS ..................7 Meaning of Signal Words ................7 Device Labels ....................8 Description of Symbols ................... 8 General Cautions and Warnings ..............9 PRESCRIPTION DEVICE STATEMENT ..............
Page 4 14.2 Selecting the Lens and Vitreous Type ............39 14.3 Selecting OD or OS ..................40 14.4 Measurement Modes ..................40 14.5 Automatic Measurement Mode ..............40 14.6 Manual Measurement Mode ................41 14.7 Selecting Immersion or Contact Measurement Modes ........43 14.8 Setting the Corneal Compression Lockout Sensitivity ........
Page 5 17.7 Exporting A-Scan PDF Reports ..............72 18 DATABASE MANAGEMENT ..................73 18.1 Importing and Exporting Data ............... 73 19 ELECTROMAGNETIC COMPATIBILITY ..............74 20 CARE AND MAINTENANCE ..................76 20.1 Care of Transducer..................76 20.2 Cleaning and Disinfecting the Transducer Tip ..........77 20.3 Cleaning and Disinfecting the Immersion Shell ..........
Page 6: General Device Description
General 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.
Page 7: Device Classification
Device 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 Indications 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.
Page 8: Device Labels
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 0120 requirements applicable requirements of 21 CFR 1010 (Performance...
Page 9: General Cautions And Warnings
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 yyyy year the device was manufactured.
Page 10 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.
Page 11: Prescription Device Statement
WARNING Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the device, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result. Prescription Device Statement CAUTION The DGH 6000 is a prescription device and is only to be used by, or under the...
Page 12: Using Ultrasonic Signals To Ascertain Correct Probe Alignment
Note: Ultrasound cannot travel through air because air is not dense enough for the high frequency waves to propagate. Ultrasonic measurements must therefore be performed by direct contact or through a denser medium such as water. Using Ultrasonic Signals to Ascertain Correct Probe Alignment Sound travels in straight lines, so the direction of reflected sound is based solely on its angle of incidence.
Page 13 Figure 7-C Correct alignment along the Figure 7-D Incorrect alignment along the visual axis. visual axis. The DGH 6000 Scanmate-A incorporates a pattern recognition program that automatically checks for proper alignment. It first looks for the proper pattern of reflectance peaks from each expected interface. Then the software examines the retinal spike for particular signal characteristics which are produced only by retinal interfaces.
Page 14: Ultrasonic Measurement
Ultrasonic Measurement The speed of sound increases in denser materials. Liquids or substances containing large amounts of water conduct ultrasound very well; air does not conduct ultrasound. Figure 7-E shows a list of the established speeds of sound for ophthalmic structures. Normal PMMA Aqueous...
Page 15 Material Velocity (m/s) Thickness (m) PMMA IOL 2780 Silicone IOL 1350 Acrylic IOL 2180 Note: The velocities table within the Scanmate application displays the preset velocities and allows the user to specify a custom velocity and thickness to be used for calculation. Custom velocities are selected as Custom Aphakic, Custom Phakic, or Custom Pseudophakic lens types.
Page 16: Ultrasonic Exposure And Intensities
Ultrasonic Exposure and Intensities Tissue Exposure to Ultrasound Energy The ultrasound energy emitted by the DGH 6000 is low intensity and will have no adverse effects on the patient and/or operator. However, the operator is still cautioned to perform examinations using the principle of ALARA (As Low As Reasonably Achievable).
Page 17: Biometric Measurement Capabilities
Biometric Measurement Capabilities The following table shows the measurement range and capabilities for the DGH 6000 (Scanmate A). Parameter Range Accuracy Resolution Axial length 15 mm to 40 mm +/- 0.1mm 0.01 mm Anterior chamber depth 2.0 mm to 6.0 mm +/- 0.1 mm...
Page 18: Login Screen
11.3 Login Screen A single username and password is used to gain access to the software and database for all users. By default, the Scanmate software is set to automatically log in when the application is started using the username password specified System...
Page 19: Configuring The Scanmate Software
Configuring the Scanmate Software 12.1 System Preferences The “System Preferences” window provides controls to set various configuration items for the system. The System Preferences window can be accessed by selecting Preferences → System from the Menu Bar. The Practice Name, Practice Address Line 1, Practice Address Line 2 and Practice Phone Number textboxes allow the user to enter practice information that will appear on reports generated by the software.
Page 20 WARNING To avoid IOL power calculation errors, it is important that the corneal refractive index (nc) of the keratometer used to calculate corneal power matches the default refractive index (nc) set in System Preferences for the DGH Scanmate. The default nc should be set before K1 and K2 are entered for a patient. The nc associated with each set of corneal power measurements can be reviewed or adjusted on the IOL Calculator Screen.
Page 21: Operator Preferences
The Hint textbox allows the user to enter a hint for the password. If a user is logging in manually, clicking the “Show Hint” button at log-in will display the hint text. To change the Hint that the DGH Scanmate application displays, select the “Change Configuration” button and follow the prompts.
Page 22 preferences are saved by clicking the “Apply” button, or can be discarded by clicking “Cancel”. The “OK” button will save the current settings and close the “Operator Preferences” window. The Delete button will delete an operator from the system. When clicked, the user is prompted for confirmation prior to deleting the operator’s preferences.
Page 23: A-Scan Page Preferences
12.3 A-Scan Page Preferences The A-Scan Page Preferences allow the user to select the Default Lens Type and Default Report. Default Lens Type is the lens type that will be entered by default when a new A-Scan procedure is started. The Default Report setting determines what report will be generated when clicking the Report button on the A-Scan Page.
Page 24 The Name combo box selects an existing doctor from the database to view, edit, or delete their preferences. The Default Doctor checkbox selects which doctor will be automatically placed on the Patient Data and IOL Calculator Screens. If only one doctor exists, that doctor is automatically set as the default doctor.
Page 25 The A-Scan Default Measurement Mode radio buttons allow the user to select either contact or immersion as the default A-Scan measurement mode for the currently selected doctor. Variables in timing used while aligning the probe can be adjusted in the A-Scan Timing box.
Page 26: Configuring Custom Velocities
The IOL 1 / IOL 2 / IOL 3 tabbed display allows the user to specify up to three preferred IOLs for the currently selected doctor. The default IOL manufacturer (Mfg), model, and formula are selected from searchable combo boxes for each preferred IOL. The IOL Calculator Screen will automatically load the Preferred IOL tabs for the currently selected doctor.
Page 27: Adding Iols To The Database
12.6 Adding IOLs to the Database The IOL Configurations button opens the IOL Information Table dialog. From this screen, the user can create, edit, view, or delete IOLs from the database. The IOL Information Table can only be opened when a doctor’s preferences are being created or edited. IOLs are specific to the doctor that creates them.
Page 28 The Manufacturer combo box allows the user to view, enter and edit the manufacturer of an IOL. The Model combo box allows the user to view, enter and edit the model of the IOL. The A-Constant is entered by the user based on the IOL manufacturer’s specifications.
Page 29: Personalizing Lens Constants
12.7 Personalizing Lens Constants Personalization of lens constants helps to improve the accuracy of a given IOL power calculation formula by correcting for consistent prediction errors caused by: • Surgical Technique • A-Scan Biometry Measurements • Keratometer Biometry Measurements • IOL Style / Geometry The Personalized Lens Constants Table allows the user to manage how Personalized Lens Constants are calculated.
Page 30: Overview
12.7.1 Overview The DGH 6000 assists the user in performing personalized lens constant calculations for the following formulas: • SRK®-T (A-Constant) • Hoffer® Q (pACD) • Holladay 1 (SF) • Haigis (Single Optimization of a0) Note: The DGH 6000 performs a Single Optimization (a0) for the Haigis Formula. Triple Optimization (a0, a1 and a2) is unavailable at this time.
Page 31: Procedure
“Personalized Lens Constants” table. This allows the doctor to view the updated calculation before accepting it with the “Up Arrow” button. Up Arrow – When this button is clicked, the values that are displayed within the “New Personalized Constants” textboxes are stored in the “Current Personalized Constants”...
Page 32 Select the IOL Calculator Screen and perform IOL Calculations as described in Section 16. Save the Pre-Operative Data used to perform the calculations by selecting the Save button. Perform the lens replacement surgery. Record the actual lens model and power that was used.
Page 33 WARNING Results for Patients That Have Undergone Corneal Refractive Surgery Should Not Be Used To Calculate Personalized Lens Constants. WARNING Only A-Scan Measurements Performed Using the DGH 6000 Should Be Used to Calculate Personalized Lens Constants. WARNING Only Stabilized Post-Operative Results Should Be Used to Calculate Personalized Lens Constants.
Page 34: The Patient Data Screen
The Patient Data Screen Upon startup, the Scanmate application will automatically open to the Patient Data Screen in Search Mode. The Patient Data Screen allows the user to Search, Create, Review and Edit patient records. 13.1 Patient Data Screen Controls The Patient Data Screen operates in three distinct modes of operation: “Search and View”, “Edit / Save Data”, and “New Patient.”...
Page 35: Entering A New Patient
The New button is used to enter new patients in the DGH-Scanmate database. When clicked, the “Last Name”, “First Name”, and “ID#” combo boxes change to plain text boxes and allow the user to enter a new patient. The Search button is used to search for patients in the DGH-Scanmate database.
Page 36: Searching For A Patient
• K1 and K2 (K1 and K2 values for OS and OD may be entered from the IOL Calculator Screen and are only needed for IOL Calculations) • Desired Refraction (Desired Refraction for OS and OD may be entered from the IOL Calculator Screen and are only needed for IOL Calculations) Note: It is important that the corneal refractive index (nc) used by the keratometer to...
Page 37: Creating A New Procedure
13.5 Creating a New Procedure Procedures are used by the Scanmate software to associate a set of patient A-Scan measurements and calculations (Pre-Operative Data) to a set of surgical outcomes (Post- Operative Data). Patient records can contain multiple procedures. To create a new Procedure, select the desired patient record following the steps described in Section 13.3.
Page 38 • Model The model of the implanted IOL • Power The power of the implanted IOL • Sph The Stabilized Post-Operative Spherical Refractive Error • Cyl The Stabilized Post-Operative Cylindrical Refractive Error • Add to Personalized Constants Table Selecting this checkbox indicates that the Doctor would like to include these Results in the Calculation of Personalized Lens Constants.
Page 39: The A-Scan Screen
The A-Scan Screen The A-Scan Screen allows the user to perform and review A-Scan Measurements for the currently selected patient. Refer to Section 13 for details on how to load or create patient records. The default settings for this page are dependent on the currently selected Doctor and Operator.
Page 40: Selecting Od Or Os
14.3 Selecting OD or OS The eye currently being measured (OD or OS) can be selected by pressing the Change Eye button. The currently selected eye is shown in the top left- hand corner of the waveform display screen. 14.4 Measurement Modes The DGH Scanmate software can be configured for Automatic or Manual measurement mode.
Page 41: Manual Measurement Mode
If alignment continues to be undetected, a warning message will appear stating that alignment accuracy requirements will be disabled, placing the system in “Estimate Mode”. All measurements, regardless of alignment, will be accepted for calculating the average. If measurements are obtained that do not show signs of alignment, they will be given an “EST”...
Page 42 On a desired frame, the measurement points can be set by the user. In Contact Mode three red arrows represent measurement points that can be selected; they represent the anterior and posterior lens surfaces (L1 and L2) and the retina (R). In Immersion Mode, the corneal peak is also visible in the waveform and is indicated by an additional arrow at the leftmost echo.
Page 43: Selecting Immersion Or Contact Measurement Modes
14.7 Selecting Immersion or Contact Measurement Modes The DGH 6000 is capable of performing both “direct contact” and “water immersion” measurements. Direct contact means that the ultrasonic probe must be applanated to the cornea. This method is the quickest and most convenient way of taking measurements. Because there is the possibility of indenting the cornea using the Contact method, the measured axial length may be shorter than its actual value.
Page 44: Performing A Contact Measurement
The Corneal Compression Lockout Sensitivity can be adjusted before replaying videos or on any paused frame to see the impact on the measurements. A red/green indicator next to the Comp Sens slider will show whether a measurement can be taken from a frame: if the indicator is red, there is too much compression for a measurement at that sensitivity level.
Page 45 † To Start scanning - Click the Start Scan button; or, - Press the Space Bar (on the keyboard); or, - Press the Foot Pedal (Single Pedal Accessory); or, - Press the Left Foot Pedal (Double Pedal accessory) A waveform will be displayed on the screen, but the unit will not begin recording.
Page 46 In Auto Measurement Mode, a measurement is automatically recorded when proper contact and alignment with the visual axis is detected. Typically, measurements will be obtained almost instantaneously. AXL, ACD and LT measurements are ranked and placed in the measurement bank. If the unit is configured for the “Aphakic”...
Page 47 Scanning is stopped as follows: In Auto Measurement Mode, the scan will stop automatically as soon as eight (8) measurements are obtained that meet the alignment ranking and standard deviation requirements. Scans can also be aborted manually (as stated below). In Manual Measurement Mode, scans must be stopped manually.
Page 48 Note: The measurement data for the first eye will remain stored in memory while measurements are being obtained on the second eye. After measurements have been taken, the operator may save a video that stores all of the waveforms captured during the exam by †...
Page 49: Performing An Immersion Measurement
14.10 Performing an Immersion Measurement Note: The Prager Shell included with the DGH 6000 comes with instructions for use and images illustrating the catheter tubing connection. Please refer to these sheets for more detailed instructions regarding the immersion shell. Before each biometry procedure, both the ultrasound transducer and the immersion shell must be cleaned.
Page 50 Gently insert the A-Scan probe into the clean and disinfected immersion shell until it reaches the auto-stop point. Verify that the transducer tip is even with the line scored on the barrel of the shell. Once the probe is properly inserted, tighten the white nylon set screw to hold the probe in place.
Page 51 Use the saline reservoir to slowly inject saline into the shell. As soon as the liquid fills the shell sufficiently to reach the tip of the transducer (about 2cc), a beep rate of approximately once per second will be heard. This means that coupling has been achieved and sound pulses are being transmitted through the eye.
Page 52 In Manual Measurement Mode, a measurement is only recorded in the measurement bank if the user presses the Enter key (on the keyboard) or Right Foot Pedal (accessory). Measurements manually placed in the measurement bank are given a “MAN” ranking. Note: It is possible to acquire a video in Manual Measurement Mode and then enter measurements during replay of the video.
Page 53 If a measurement is observed which is suspect because it does not agree with the other measurements, the measurement may be removed and replaced as follows: Select the Manual Mode radio button (if not already in Manual Measurement Mode). Using the mouse, RIGHT-CLICK the measurement in the measurement bank you wish to remove and select “Remove Measurement”...
Page 54: Saving A Measurement File
14.11 Saving a Measurement File A Measurement File is a group of up to eight (8) A-Scan measurements and their associated waveforms for both OS and OD. Measurement Files can be saved by selecting the Save Meas Button on the upper right-hand corner of the A-Scan Screen.
Page 55: Voice Controls
14.14 Voice Controls Some controls can be operated via verbal commands from the user. Voice control can be enabled/disabled through the Preferences → System menu. Voice control can be configured to begin upon pressing the “Enter” key or by a verbal command of “Hey Flex”.
Page 56: The B-Scan Screen
The B-Scan Screen The B-Scan Screen allows the user to perform and review B-Scan exams for the currently selected patient. Please refer to the DGH 8000 Scanmate-B or Scanmate Flex User Guide for more information on using the B-Scan Screen. Page 56 of 89 6000-INS-OMENG Rev.
Page 57: The Iol Calculator Screen (Optional Feature)
The IOL Calculator Screen (Optional Feature) The IOL Calculator Screen allows the user to perform and review intraocular lens power calculations for the currently selected patient. If available, measurements and the selected lens and vitreous type are automatically loaded from the A-Scan page. Information from the Patient Data screen, including Patient Name, Patient ID, and Doctor are also automatically loaded.
Page 58: Iol Calculator Screen Controls
16.1 IOL Calculator Screen Controls Depending on the selections made by the user, up to four (4) action buttons are available at the top right corner of the IOL Calculator Screen. The K-Corr button launches the Post Refractive Surgery Calculator. The “Post Refractive”...
Page 59: Post Refractive Selection
16.5 Post Refractive Selection Select the Post Refractive checkbox if the patient has previously undergone refractive eye surgery. Selecting this checkbox enables the post refractive calculator which assists the doctor in predicting the true corneal power of eyes that have undergone corneal refractive surgery. See Section 16.16 and 16.17 for more details on using the Post Refractive Calculator.
Page 60: Corneal Power (K1 And K2)
16.8 Corneal Power (K1 and K2) The corneal power values (K1 and K2) for the current patient are entered in these fields. When the Save button is selected on the IOL Calculator Screen, these values will automatically be saved in the “Pre-Op” section of the IOL Calculator Screen for the current patient and procedure.
Page 61: Selecting Personalized Lens Constants
16.12 Selecting Personalized Lens Constants The Personalized checkbox allows the user to use a personalized lens constant for the selected formula. This checkbox is only selectable if the lens constant for the selected formula can be personalized, and the “minimum number of cases” has been reached using the currently selected IOL. (See Section 12.7 for more information on how to calculate personalized lens constants.) 16.13 K Correction Method Selection This drop-down box selects between different methods of predicting the true corneal...
Page 62: Post Refractive Calculation Methods
16.16 Post Refractive Calculation Methods It has been well established that the corneal power for patients that have undergone corneal refractive eye surgery cannot be accurately measured using current keratometry or topography methods. The Post Refractive Calculator included with the DGH Scanmate helps predict the true corneal power for patients that have undergone corneal refractive surgery.
Page 63 The best method in any instance will depend largely on the available patient information. The following section gives a brief description of the post-refractive formulas and their required inputs. History Derived – The History Derived method is considered to be one of the most accurate methods for determining the true post-surgical corneal power.
Page 64 Contact Lens Over-Correction (CL Over-Corr) - This method requires the doctor to place a plano hard contact lens of a known curvature on the patient’s eye. If the refraction remains the same, the corneal curvature is equal to that of the contact lens. If the over-refraction results in a higher myopic error, the difference in refraction is added to the base curve value.
Page 65: Using The Post Refractive Calculator
16.17 Using the Post Refractive Calculator Select the Post Refractive checkbox on the IOL Calculator Screen next to the eye that previously undergone corneal refractive surgery. This will automatically open the Post Refractive K Calculator. Note: The Post Refractive K Calculator can be opened again at any time by selecting the Kcorr button on the IOL Calculator Screen.
Page 66: Performing Iol Calculations
Select the Calculate button to calculate the corrected corneal power (Kcorr). If a required input is missing, the calculation will be cancelled and the necessary field will be highlighted in red. A successful calculation will display the Kcorr in the “Outputs” section of the calculator. Kcorr is given in diopters (D) using a keratometer index (nc) of 1.3375.
Page 67 The calculated IOL powers are NOT to be interpreted as suggested or recommended implant powers on the part of DGH Technology, Inc. The calculated IOL should be used as a guideline only. It is based upon the accuracy of the IOL formula used and the data entered.
Page 68: Overview Of Iol Power Calculation Formulas
16.19 Overview of IOL Power Calculation Formulas The following IOL Power Calculation formulas are included in the DGH Scanmate IOL Calculator. • SRK®-II • SRK®-T • Haigis • Hoffer® Q • Holladay 1 • Binkhorst II The formulas selected for inclusion are commonly used, and have been refined from earlier models.
Page 69: Factors Impacting The Accuracy Of Iol Power Calculations
16.20 Factors Impacting the Accuracy of IOL Power Calculations Many factors play a role in predicting the correct IOL power for a patient. Several of the most common factors are described in the following sections. 16.20.1 Axial Length Axial length measurement is the most important factor affecting IOL power calculations.
Page 70: Postoperative Anterior Chamber Depth
16.20.3 Postoperative Anterior Chamber Depth The anterior chamber depth is another factor that affects IOL power calculations. An error of 1.0 mm affects the postoperative refraction by approximately 1.0 diopter in a myopic eye, 1.5 diopters in an emmetropic eye, and up to 2.5 diopters in a hyperopic eye.
Page 71: Creating Reports
Creating Reports Reports can be created for viewing from the Menu Bar. The DGH Scanmate software can produce IOL Calculator Reports, A-Scan Short Reports, A-Scan Custom Reports and B-Scan Reports. Reports can be printed out, saved as PDF files and added to the patient record database.
Page 72: Using Reports
17.5 Using Reports All reports can be printed, browsed, and saved in the same ways. Clicking the small printer icon in the top left corner will send the report to the printer. The arrows and magnifier icon next to the printer icon will navigate through the report.
Page 73: Database Management
Database Management Patient data, scan images, measurements, video files, and reports created by the Scanmate application are saved in an DGH-Scanmate database. The database allows patient records to be shared, centralized, or accessed remotely, according to the needs of each biometry department. For example, several operators in a large practice could use several Scanmate Flex, DGH 6000 or DGH 8000 units simultaneously, but all patient records would be stored in a central database.
Page 74: Electromagnetic Compatibility
Guidance and Manufacturer’s Declaration: Electromagnetic Emissions The DGH 6000 Scanmate A is intended for use in the electromagnetic environment specified below. The customer or the user of the DGH 6000 should ensure that it is used in such an environment.
Page 75 Guidance and Manufacturer’s Declaration: Electromagnetic Immunity The DGH 6000 Scanmate A is intended for use in the electro-magnetic environment specified below. The customer or the user of the DGH 6000 should ensure that it is used in such an environment.
Page 76: Care And Maintenance
Care and Maintenance WARNING Users of the DGH 6000 Scanmate-A have an obligation and responsibility to provide the highest degree of infection control possible to patients, co-workers and themselves. To avoid cross contamination, follow all infection control policies established for the office, department or hospital as they apply to personnel and equipment 20.1 Care of Transducer...
Page 77: Cleaning And Disinfecting The Transducer Tip
20.2 Cleaning and Disinfecting the Transducer Tip Keep the transducer tip clean and disinfected. To prevent patient-to-patient infection, a disinfection procedure should be followed after each patient. After disinfection, the tip should be rinsed in sterile distilled water before using. The following disinfectants are recommended due to their compatibility with the probe tip material.
Page 78 Instructions for Disinfecting Transducer Surfaces when Using a Cavicide Wipe Wear protective gloves when performing the disinfecting procedure. Detach the transducer from the unit. Check the expiration date on the wipes that are being used. Use only wipes that are within the expiration date. Thoroughly wet down the transducer tip, housing and cable (if applicable) according to the standard operating procedure (SOP) or equivalent document established by your facility or institution.
Page 79: Cleaning And Disinfecting The Immersion Shell
Do not immerse the probe tip for longer than one hour. The probe tip may be damaged by longer immersion times. Disinfect the probe tip using only the liquid solutions above. Using autoclave, gas (EtO), or other non DGH Technology approved methods will damage the probe and void the warranty. WARNING The transducer should NEVER be autoclaved or subjected to intense heat.
Page 80: Care Of Usb Interface Module
The connectors should not be exposed to water. 20.6 Operating Conditions The DGH6000 (Scanmate A) should be operated between temperatures of 18 C and 20.7 Verifying A-Scan Calibration The DGH 6000 uses a pattern recognition algorithm that looks for unique characteristics of the human retina to obtain true probe alignment.
Page 81: Storage
Contact the Customer Service Depart- ment of DGH Technology, Inc. at (610) 594-9100 to arrange for repair. If desired, the results of the calibration check can be saved in the “Test Block”...
Page 82: Disposal
20.10 Disposal Contact DGH Technology, Inc. before disposing of the DGH 6000. Concerning the WEEE label, the following information is for EU member states: The use of this symbol indicates that this product should not be treated as household waste. By ensuring that this product is disposed of correctly, you will help prevent potential negative consequences for the environment and human health, which could otherwise be caused by inappropriate waste-handling of this product.
Page 83: Warranty
Warranty DGH Technology, Inc. “DGH” warrants each new DGH 6000 and its accompanying accessories (hereinafter called “Equipment”) to be free from defects in material and workmanship for twelve (12) months from the date of delivery to the original purchaser. This warranty is not applicable to any defect that is the result of an accident, misuse, mishandling, neglect, improper installation, improper repair or improper modification by persons other than DGH.
Page 84: Customer Service
However, if you feel there is a problem with the unit or a transducer, please contact the Customer Service Department at the address below. DGH Technology, Inc. can also be contacted via our website at www.dghtechnology.com. When contacting us, please provide the model and serial number for the unit.
Page 85: Appendix Acomputer System Specifications
APPENDIX A COMPUTER SYSTEM SPECIFICATIONS System Requirements Minimum Recommended Processor: 2.0 GHz 3.0+ GHz Architecture: 32-bit or 64-bit 64-bit Memory: 2 GB RAM 4 GB RAM Hard Drive: HDD or SSD Storage Space: 128 GB 500 GB Display: 1024 x 768 resolution Peripherals: Mouse/Touchpad, Keyboard Ports:...
Page 86: Appendix Bscanmate-A Specifications
APPENDIX B SCANMATE-A SPECIFICATIONS Transducer Starting Frequency: 12.5 MHz +/- 1.25 MHz. Damped Frequency: 10.0 MHz (nominal) Fixation LED Focused Acoustic Beam (23.0 mm nominal) Detachable (via Lemo Connector) Probe Dimensions: L 55.7 mm x D 6.6 mm Cord Length: 195 cm USB Interface Module Dimensions: L 146 mm x W 88 mm x H 38 mm Weight: 285 gm...
Page 87: Appendix Creferences
APPENDIX C REFERENCES IOL formulas: The IOL Power Calculations are based on formulas published in peer- reviewed journals. Binkhorst II JEDMED Internal documents, based on Binkhorst, R.D. “Pitfalls in Determination of Intraocular Lens Power Without Ultrasound.” Opthalmic Surgery 7:68 (1976): 69-82. STORZ CompuScan LT.
Page 88 Post Refractive Surgery Formulas By in large, these methods have been implemented as described in H. John Shammas’s book “Intraocular Lens Power Calculations” published by Slack Incorporated 2004. History Derived = pre-K S.E. S.E. corr post (1 - S.E. (1 - S.E. post Refraction Derived post-K...
Page 89: Appendix Dterms And Abbreviations
APPENDIX D TERMS AND ABBREVIATIONS The following terms and abbreviations are used within this Operator’s Manual and in the Scanmate program: A-constant The A-constant is a constant provided by an IOL manufacturer to be used in IOL power calculations. Anterior Chamber Depth is defined as the measured distance from anterior vertex of the cornea and the anterior vertex of the lens.

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