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8000-INS-UMENG Rev. 4

DGH 8000 (SCANMATE-B)

ULTRASONIC B-SCAN

Scanmate

DGH 8000

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

REP

EMERGO EUROPE

DGH 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

REP

EMERGO EUROPE

DGH TECHNOLOGY, INC.

110 SUMMIT DRIVE
SUITE B
EXTON, PA 19341
USA (610) 594-9100

Prinsessegracht 20
2514 AP, The Hague
The Netherlands

Molenstraat 15
2513 BH, The Hague

The Netherlands

Phone: +31.70.345.8570

REP

EMERGO EUROPE

DGH TECHNOLOGY, INC.

110 SUMMIT DRIVE
SUITE B
EXTON, PA 19341
USA (610) 594-9100

Содержание Scanmate-B DGH 8000

Страница 1: ...REP EMERGO EUROPE DGHTECHNOLOGY INC 110 SUMMIT DRIVE SUITE B EXTON PA 19341 USA 610 594 9100 Molenstraat15 2513BH TheHague The Netherlands Phone 31 70 345 8570 EC REP EMERGO EUROPE DGHTECHNOLOGY INC 110 SUMMIT DRIVE SUITE B EXTON PA 19341 USA 610 594 9100 Prinsessegracht 20 2514 AP The Hague The Netherlands Molenstraat15 2513 BH The Hague The Netherlands Phone 31 70 345 8570 EC REP EMERGO EUROPE D...

Страница 2: ...Page 2 of 53 8000 INS UMENG Rev 4 This page intentionally left blank ...

Страница 3: ...Application 10 11 2 Splash Screen 11 11 3 Login Screen 11 11 4 No USB Devices Detected Warning 11 11 5 Touch Controls 11 12 CONFIGURING THE SCANMATE SOFTWARE 12 12 1 System Preferences 12 12 2 Operator Preferences 14 12 3 B Scan Page Preferences 16 12 4 Doctor Preferences 17 13 THE PATIENT DATA SCREEN 18 13 1 Patient Data Screen Controls 18 13 2 Entering a New Patient 19 13 3 Searching for a Patie...

Страница 4: ...ports 40 17 3 Opening Reports 40 17 4 Exporting B Scan PDF Reports 40 18 DATABASE MANAGEMENT 41 19 IMPORTING AND EXPORTING DATA 41 19 1 Importing Legacy Files bs or cini 42 20 ELECTROMAGNETIC COMPATIBILITY 43 21 CLEANING AND DISINFECTION 45 21 1 Probe Cleaning 45 21 2 Probe Disinfection 45 22 CARE AND MAINTENANCE 47 22 1 Care of the USB Probe 47 22 2 Maintenance of the USB Probe 48 22 3 Operating ...

Страница 5: ...probe and displays a Brightness Scan that shows the relative magnitude of the echo spikes received by the transducer The software allows the user to adjust the scan rate of the probe 12 or 15 MHz as well as the gain contrast intensity and depth of the displayed image Once the exam is complete the application allows the user to save video s image s or create a report to document the results 2 Devic...

Страница 6: ...ator 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 conform...

Страница 7: ... 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 electron...

Страница 8: ... 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 images WARNING U...

Страница 9: ... can be examined with ultrasound When ultrasound penetrates an object with several interfaces the reflected ultrasound can be observed on a display as a Brightness Scan that shows the relative position and magnitude of the echo spikes received by the transducer Note Ultrasound cannot travel through air because air is not dense enough for the high frequency waves to propagate Ultrasonic measurement...

Страница 10: ...er tissue with the system activated except when performing an exam Do not perform unnecessary exams 8 2 Ultrasonic Intensities See Appendix B of this manual for acoustic measurements 9 Biometric Imaging Capabilities The following table shows the resolution for the DGH 8000 Scanmate B Parameter Electronic Clinical Resolution 0 015 mm 0 1mm 10 Installation and Configuration of Scanmate Software Refe...

Страница 11: ...te the log in and allow the Scanmate software to be used without the USB probe Although no scans can be completed the software can still be used to review B Scan images videos and reports If the Scanmate software is being used without the DGH 8000 probe attached the software will require probe key authentication before using and after every 20 hours of use Warnings will appear every hour after 15 ...

Страница 12: ...y the software The Date Format textbox allows the user to select either MM dd yyyy or dd MM yyyy date format for the software The Automatic Login checkbox allows the user to select if login is required upon system startup or if the user is automatically logged in By default this checkbox is enabled indicating that the username and password will be entered automatically The Report PDF Export Locati...

Страница 13: ...able The Username textbox displays the username that the Scanmate application uses to connect to the database To change the Username for the DGH Scanmate application select the Change Configuration button and follow the prompts For more information on configuration of the software refer to the Scanmate Installation Guide The Password textbox displays the password that the Scanmate application uses...

Страница 14: ...reate new operators and assign preferences to the newly created operator The Edit Name button allows the user to make changes to an existing operator s preferences To change an operator s preferences click the Edit button while the desired operator s name is selected in the Name combo box Changes to operator preferences are saved by clicking the Apply button or can be discarded by clicking Cancel ...

Страница 15: ...left to right increases the number of frames stored in the buffer Increasing the number of frames that can be stored in the buffer allows the user to determine the amount of video that is captured before it begins to overwrite itself The video buffer can be configured to store from 16 to 256 frames The B Scan Default Zoom slide bar adjusts the amount of magnification applied to the image or video ...

Страница 16: ...e top position on the probe Note Changing the image reference setting will change the orientation of the images stored in the database If this reference is changed after images have been acquired any measurements overlaying the image will need to be redrawn The Scan Speed setting determines the number of frames that are acquired per second during a scan The Start Scan Button Configuration setting ...

Страница 17: ...ws the user to make changes to an existing doctor s preferences The user can change a doctor s preferences by clicking this button while the desired doctor s name is selected in the Name combo box The Delete button deletes a doctor from the system When clicked the user is prompted for confirmation prior to deleting the doctor s preferences Once deleted the doctor will still exist in the database b...

Страница 18: ... 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 The action buttons on the top right hand side of the screen change availability depending on the current mode of the Patient Data screen The patient data screen buttons include Open File New Search Edit...

Страница 19: ...abase The Undo button allows the user to undo the last changes that were made to the Patient s Record All fields will revert to the most recent saved state The Open File button allows the user to open a window to review all records associated with the selected patient 13 2 Entering a New Patient Select the New button and enter the following required fields Last Name First Name ID Number The ID Num...

Страница 20: ...ients can be searched for by Last Name First Name or by ID Number To search by Last Name First Name or ID Number begin typing in the field you wish to search The software will automatically update the patient table to show all the results that match what has been typed The desired patient can then be selected from this patient list 13 4 Editing a Patient Record Select the desired patient record to...

Страница 21: ...an Screen The A Scan Screen allows the user to perform and review A Scan Measurements for the currently selected patient Refer to the DGH 6000 Scanmate A or the Scanmate Flex User Guide for instructions on using the A Scan features of this program ...

Страница 22: ...the currently selected Operator The default settings can be changed by selecting Preferences Operator 15 1 Selecting the Probe Select the desired probe from the list of available probes in the Probe Type combo box The available Pulse Frequencies will be displayed for the selected probe The Depth selection adjusts the depth of the displayed B Scan image Note Pulse Frequency is the rate that the pro...

Страница 23: ...g the Change Eye button The currently selected eye is shown in the top left hand corner of the B Scan display 15 5 Scanning and Recording IF the software is configured as Scan and Record Preferences B Scan Page the software will begin recording as soon as the scan is started IF the software is configured as Scan Only Preferences B Scan Page the software will begin scanning but will not start or st...

Страница 24: ...st of the image Adjust this control to increase or decrease the amount of contrast between light and dark areas of the image 15 7 Saving Operator Settings The current image control settings Gain Intensity Contrast can be saved to the active operator by selecting the Save Settings button Whenever the operator is selected the image controls will default to the saved settings 15 8 Video Controls Use ...

Страница 25: ...ic A Scan overlay Enabling the A Scan Overlay will superimpose an A Scan waveform over the B Scan image or video Use a left click to place the vector in the desired position 15 10 Adding Exam Comments Select the Comments button to enter comments The comments box can be dragged to any location on the image ...

Страница 26: ...click hold and drag the mouse across the image Additional measurement can be added by clicking the button again and dragging additional caliper lines This can also be performed using touch controls The caliper measurement values are displayed near the caliper line Caliper lines can be adjusted and moved by left clicking the line and dragging the control nodes to the desired position Caliper notati...

Страница 27: ...take area measurements Left click hold and drag the mouse across the image to produce the first side of the desired area then repeat left click hold and drag to produce additional sides of the desired area This can also be performed using touch controls Once the area is encompassed a measurement will be displayed showing the measurement in mm2 Area measurements can be adjusted and moved by left cl...

Страница 28: ...normal resolution Zoom can also be controlled via voice commands Refer to Section 15 25 for more information If the PC running the Scanmate application has a touch capable display zooming may be performed using pinch zoom touch controls To zoom in place two fingers on the B scan image being displayed and move them apart To zoom out place two fingers on the B scan image being displayed and move the...

Страница 29: ...ker is generally aimed either superiorly or nasally Axial Probe Positions An axial scan provides an image of the posterior globe with the optic nerve centered on the right side of the image The probe is positioned so that it is centered on the cornea while the patient is looking forward When properly aligned the optic nerve will be centered on the right side of the image Example of 12 00 AX VAX Sc...

Страница 30: ...e marker is pointed towards the limbus causing the optic nerve to be towards the bottom of the image Example of 12 00 L Scan For a 12 00 Longitudinal scan the marker on the tip of the probe is pointed toward the area being examined at 12 00 The probe is positioned at 6 00 which is opposite of the area being examined Use the selection tool to indicate the meridian being scanned Once the desired pos...

Страница 31: ...s while the patient is looking toward the area of the eye being examined The probe marker is held parallel to the limbus and pointed superiorly during vertical and oblique scans For horizontal scans 6 00 and 12 00 positions the marker is pointed nasally to keep it parallel to the limbus For a 12 00 EP scan the probe is positioned at 6 00 with the marker parallel to the limbus and pointed nasally T...

Страница 32: ...is a vertical transverse scan where the probe has been aligned so that it is pointed temporally 3 00 OS or 9 00 OD directly at the macula 15 18 Saving B Scan Images B Scan Images can be saved by selecting the Save Image Button on the upper right hand corner of the B Scan Screen This will also save all changes that have been made to the Patient Data since the last save Alternatively the currently l...

Страница 33: ...how saved records for both eyes OU or to only show records for the right OD or left OS eye Records can be deleted by Right clicking and selecting Delete from the context menu The Aspect Ratio of the window vertical vs horizontal can easily be changed The presence of an orange highlight means the video image is currently being displayed 15 21 Saving B Scan Images as Jpegs It is possible to convert ...

Страница 34: ...formation doctor operator and date A window with all the saved images and videos for the current patient will open Use the checkboxes in the bottom right corner of each image to include them in the report The selected images will be shown inserted in a report preview window Clicking the Add Comments button in the report preview will open a comment box for text entry Reports can be sent to a printe...

Страница 35: ... operator by selecting Preferences Operator and clicking the New button 6 Seat or recline the patient in a comfortable position Use a firm comfortable head rest to prevent unwanted head movement Position the DGH Scanmate display so that it is easily visible during the examination 7 If desired use the Position Map to indicate the area of the eye being examined 8 To Start scanning Click the Start Sc...

Страница 36: ...ed to play back the video of the exam Alternatively the slider below the B Scan display can be used to move through the video frame by frame 13 Use the Gain Intensity Contrast and Zoom controls to enhance the quality of the image If desired annotate the exam with comments or use the A Mode Area Angle and Caliper Tools 14 To save images click the Save Image button upper right hand corner or select ...

Страница 37: ...ds Start Scan Verbal Starting Scan The B scan will start Stop Scan Verbal Scan Stopped The B scan will stop Change Eye Verbal Eye changed to OD OS The eye being scanned is changed The audible response will state if OD or OS is being scanned Zoom In N A Zoom will enlarge the image or video Zoom Out N A Zoom will reduce the image or video Show Ruler N A The ruler overlay is shown Hide Ruler N A The ...

Страница 38: ...tor Screen The IOL Calculator Screen allows the user to perform and review intraocular lens power calculations for the currently selected patient Refer to the DGH 6000 Scanmate A or the Scanmate Flex User Guide for instructions on using the IOL Calculator ...

Страница 39: ...he report 17 1 B Scan Report Click the Report button on the B Scan Screen to quickly create a B scan report A window with all the saved images and videos for the current patient will open Mark the checkboxes in the bottom right corner of each image to have them included in the report Images are inserted into the report in the order they are selected The selected images will be shown inserted in a ...

Страница 40: ...it the report and return to the Scanmate application 17 3 Opening Reports To view a previously saved report select the patient through the Patient Data screen search Using the Menu Bar go to File Open or click the Open File button This will open a window that shows all saved images videos and reports for the current patient Each report is automatically given a unique name consisting of the type of...

Страница 41: ...ns or by other practitioners If both locations have the Scanmate Software v3 0 0 or later installed the best way to exchange B Scan files is to use the bscan file format This format includes all the necessary information to completely identify the patient and to re create the record in the database It is also possible to export jpg images or avi movies to share with practitioners that do not have ...

Страница 42: ...information to be included in the DGH Scanmate database a dialog window will open requesting additional information when importing these file types Select the Patient that you would like to associate the imported file with If the desired patient is not shown select Cancel and add the patient to the database Verify that the Eye OD or OS and the Scan Date are correct and select Import Once opened th...

Страница 43: ...EN 55011 2009 A1 2010 CISPR 11 2009 A1 2010 Class A Group 1 150 kHz to 30 MHz Complies The device uses RF energy for its internal function Nearby electronic equipment may be affected Radiated Emissions EN 55011 2009 A1 2010 CISPR 11 2009 A1 2010 Class A Group 1 30 MHz to 1 GHz Complies Mains power quality should be that of a typical commercial or hospital environment If the user of the device requ...

Страница 44: ...loors are covered with synthetic material the relative humidity should be at least 30 Radiated Immunity IEC EN 61000 4 3 IEC EN 60601 1 2 2014 4th Ed 80 MHz 6 GHz 3 V m 10 V m 80 1 kHz Spot frequencies 385MHz 5 750 GHz Pulse Modulation Complies Field strengths outside the shielded location from fixed RF transmitters as determined by an electromagnetic site survey should be less than 3 V m Interfer...

Страница 45: ...with a dry cloth 21 2 Probe Disinfection The following disinfectants are recommended due to their biological effectiveness as well as their chemical compatibility with the DGH 8000 materials WARNING Users of the DGH 8000 Scanmate B have an obligation and responsibility to provide the highest degree of infection control possible to patients co workers and themselves To avoid cross contamination fol...

Страница 46: ...or towel dry with a clean cloth 7 Examine the probe for damage such as cracks splitting fluid leaks or sharp edges or projections If damage is evident discontinue use of the probe and contact a customer service representative WARNING DGH makes no claims about the biological effectiveness as a disinfectant of any of the products listed above Furthermore DGH makes no claims regarding the effectivene...

Страница 47: ... can damage or discolor the probe and will void the probe warranty Do not immerse the probe tip for longer than one hour The probe may be damaged by longer immersion times Disinfect the probe tip using only the liquid solutions Using autoclave gas EtO or other non DGH Technology approved methods will damage the probe and void the warranty Regularly check the front face of the probe for cracks as t...

Страница 48: ...rt Liquids or condensation Impact Store the DGH 8000 under the following ambient conditions Temperature 10 C to 50C 14 F to 122 F Relative Humidity 20 to 80 no condensation Atmospheric pressure 70 kPa to 106 kPa 22 5 Transportation Never carry the DGH 8000 by the USB cable Never bend the USB cable in a tight radius This could result in damage to the cable Transport the DGH 8000 under the following...

Страница 49: ...er repair or improper modification by persons other than DGH This warranty does not apply if the Equipment has not been operated and maintained in accordance with the operating and maintenance manuals and instructions or bulletins issued in respect thereof by DGH The cost of servicing replaceable and expendable items including parts and labor made in connection with the routine maintenance service...

Страница 50: ...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 The model number and serial number are located on the side of the USB probe and can also be viewed on the display by selecting the About button found on the He...

Страница 51: ...2 GB RAM 4 GB RAM Hard Drive HDD or SSD SSD Storage Space 128 GB 500 GB Display 1024 x 768 resolutionA Peripherals Mouse Touchpad Keyboard Ports 2x USB 2 0B PC Power Supply AC DC Medical Grade TransformerC Compatible OS Microsoft Windows 7 32 bit 64 bit Microsoft Windows 8 1 32 bit 64 bit Microsoft Windows 10 32 bit 64 bit Microsoft Windows Server 2008 R2D 64 bit Microsoft Windows Server 2012 2012...

Страница 52: ...rage intensity mW cm2 1 26 1 26 NA NA 1 26 NA NA Attenuated spatial peak temporal average intensity mW cm2 0 41 0 41 NA NA 0 41 NA NA Peak rarefactional acoustic pressure MPa 1 14 1 14 NA NA 1 14 NA NA Attenuated peak rarefactional acoustic pressure MPa 0 65 0 65 NA NA 0 65 NA NA 1 2 dB output beam area cm2 0 28 0 28 NA NA 0 28 NA NA Equivalent aperture diameter cm 0 60 0 60 NA NA 0 60 NA NA Depth...

Страница 53: ...Freeze Electronic 0 015 mm Clinical 0 1 mm True 256 8 bits shades of gray 60 degree sector High Bandwidth single element 12 MHz 15 MHz 3 cm 6 cm 12 MHz 5 cm 10 cm 15 MHz 2 calibers for distance measurements Image Post processing TGC control s near mid and far Contrast and Image Intensity controls Frame averaging Interpolation Exam data Patient name and comments Video buffer range up to 512 frames ...

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