Related Manuals for DGH TECHNOLOGY SCANMATE FLEX
Summary of Contents for DGH TECHNOLOGY SCANMATE FLEX
- Page 1 SCANMATE FLEX ULTRASOUND PLATFORM OPERATOR’S MANUAL FOR USE WITH SCANMATE v4.2 SOFTWARE 0120 DOCUMENT #: FLEX-INS-OMENG-R4...
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Page 2: Table Of Contents
2 TABLE OF CONTENTS WARNINGS AND CAUTIONS SYMBOL DEFINITIONS TERMS AND ABBREVIATIONS GENERAL DEVICE DESCRIPTION, DEVICE CLASSIFICATION INDICATIONS FOR USE CONTRAINDICATIONS PRESCRIPTION DEVICE STATEMENT OPERATOR QUALIFICATIONS ALARA STATEMENT 10 SYSTEM COMPONENTS 12 REMOVING THE UBM TRANSDUCER 13 INITIAL SETUP AND ENABLING/DISABLING THE RECHARGEABLE BATTERY 14 SOFTWARE MODES AND SYSTEM MENUS 15 DOCTOR PREFERENCES MENU 17 OPERATOR PREFERENCES MENU... - Page 3 46 CLEANING AND DISINFECTION 49 ROUTINE MAINTENANCE—PHYSICAL INSPECTION 50 ROUTINE MAINTENANCE—VERIFYING A-SCAN CALIBRATION 51 REPAIRS AND CUSTOMER SUPPORT 52 ULTRASONIC EMISSIONS INFORMATION 58 ELECTROMAGNETIC IMMUNITY AND EMISSIONS 61 ENVIRONMENTAL CONDITIONS 61 SHELF-LIFE / LIFETIME 61 DISPOSAL 62 TROUBLESHOOTING GUIDE 64 WARRANTY...
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Page 4: Warnings And Cautions
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 Scanmate Flex, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result. -
Page 5: Symbol Definitions
TYPE B APPLIED PART [3] REF NO. 5840 This symbol indicates the degree of protection against electric shock. The Scanmate Flex is classified as Type B Applied Part. This symbol is located on the unit label. CLASS II EQUIPMENT [3] REF NO. - Page 6 Indicates a USB connection port. DIRECT CURRENT [3] REF NO. 5031 Indicates the connection port for the power supply. Adjacent text indicates the input current voltage and amperage. WEEE SYMBOL Indicates that the equipment consists of electronic components and other assemblies that must not be disposed of as domestic refuse.
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Page 7: Terms And Abbreviations
TERMS AND ABBREVIATIONS The following terms and abbreviations are used within this Operator’s Manual and in the Scanmate software. The A-constant is a constant provided by an IOL manufacturer to be used in A-constant 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. -
Page 8: General Device Description
GENERAL DEVICE DESCRIPTION The Scanmate Flex is a diagnostic ultrasound device used by professionals in the ophthalmic field to produce images and measurements of the eye and orbit of adult patients. The system consists of three main components: an interface module with integrated probe holder, one or more ultrasonic probes, and the Scanmate software application. -
Page 9: Indications For Use
ALARA STATEMENT The ultrasound energy emitted by the Scanmate Flex is of 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 10: System Components
SYSTEM COMPONENTS The Scanmate Flex is capable of operating various probes. The following tables describe the Scanmate Flex device and supported probe specifications. USB INTERFACE MODULE — FLEX-USBIM Battery Charge Check Button Battery Charge Indicator Lights (blue) Active Charging Indicator Light (amber) - Page 11 A-SCAN PROBE— DGH 6006 Probe Lens w/ Fixation LED Immersion Shell Stop Probe Handle Cord Strain Relief Probe cord to cable DGH 6006 Engraving TRANSDUCER 10 MHz (nominal) FOCAL POINT LED brightness adjustable 0% - 100% in software. AXL MEASUREMENT RANGE 15.0 mm —...
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Page 12: Removing The Ubm Transducer
UBM PROBE — DGH1500* Removable Transducer O-Ring Rubber Gasket Probe Top Identifier Probe Handle Probe Connector DGH1500 Label TRANSDUCER MODEL DGH1500-35 DGH1500-50 TRANSDUCER FREQUENCY* 35 MHz 50 MHz SCAN ANGLE DISPLAYED 30 degrees 30 degrees FOCAL POINT 12.8 mm (nominal) 12.8 mm (nominal) DEPTH OF FIELD 11.5 mm—14 mm... -
Page 13: Initial Setup And Enabling/Disabling The Rechargeable Battery
CAUTION: If it is difficult to connect the probes and/or cables, do not force the connection. Verify that alignment between connectors is correct. If proper alignment cannot be determined, contact DGH Technology, Inc. for customer assistance. Installation of the Scanmate software can be performed on multiple computers as needed. -
Page 14: Software Modes And System Menus
The Reports Menu allows the user to generate reports from patient records. See the corresponding section for information on creating A-Scan, B-Scan/UBM and IOL Calculator reports. HELP MENU The Help Menu contains a link to the user manual, software/system information and contact information for DGH Technology, Inc. -
Page 15: Doctor Preferences Menu
DOCTOR PREFERENCES MENU The Doctor Preferences Menu allows the user to create, edit or delete individual doctor preferences for the device. Doctor Preferences define the default protocol for performing A-Scans and IOL Calculations. A-SCAN AUTO STOP CRITERIA This section allows the user to create standard deviation thresholds to use with the software Auto Stop feature. - Page 16 IOL 1/IOL 2/IOL 3 TABS Allow the user to specify up to three preferred IOLs for the currently selected doctor. IOL information is saved in the system using the IOL Configuration Table. A-SCAN VELOCITIES TABLE Click the [A-SCAN VELOCITIES TABLE] button. The table displayed allows the user to view the speeds of sound for each lens and vitreous type.
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Page 17: Operator Preferences Menu
AUTOMATIC CONSTANTS UPDATE Selecting the [AUTOMATIC CONSTANTS UPDATE] checkbox enables the Automatic Constants Update feature. This feature automatically calculates and updates the personalized lens constant for the selected doctor and lens based on the records in the table that have “Use Record”... -
Page 18: Scan
A-SCAN PAGE PREFERENCES The A-Scan Page Preferences allow the user to select the Default Lens Type and Default Report. Default Lens Type: This is the lens type that will be entered by default when a new A-Scan procedure is started. Default Report: This setting determines what report will be generated when clicking the [REPORT] button on the A-Scan Page. -
Page 19: Patient Screen
PATIENT SCREEN The Patient Screen allows the user to search patients and create new or edit existing records. The selected patient’s records will be displayed when the A-Scan, B-Scan or IOL tabs are clicked. Create New Patient: To create a new patient, click the [NEW] icon in the upper right-hand corner. -
Page 20: Scan/Ubm Screen
B-SCAN/UBM SCREEN The B-Scan/UBM Screen allows the user to perform B-Scan/UBM procedures and review the loaded patient’s B-Scan/UBM records. Open File: To view B-Scan/UBM images, videos and records associated with the current patient, click the [OPEN FILE]† button in the upper right-hand corner. -
Page 21: Using Clearscan® Covers With B-Scan Probes For Sterile Examinations
USING CLEARSCAN® COVERS WITH B-SCAN PROBES FOR STERILE EXAMINATIONS WARNING: Before each procedure, the ultrasound probe and probe adapter must be cleaned and disinfected. ClearScan® covers cannot be cleaned or reused. Refer to the Cleaning and Disinfection section. NOTE: Before beginning an examination, verify that the ophthalmic gel being used is labelled as sterile, that all packaging is intact and that the ophthalmic gel has not expired. -
Page 22: Performing B-Scans
PERFORMING B-SCANS WARNING: Before each procedure, the ultrasound probe must be cleaned and disinfected. ClearScan® covers cannot be cleaned or reused. Refer to the Cleaning and Disinfection section. NOTE: Exams are typically performed at the highest Pulse Power setting unless the image is saturated and better definition between tissue structures is desired. - Page 23 To Stop scanning†: - Click the [STOP SCAN] button; or - Press the Space Bar (keyboard); or - Press the Foot Pedal (Single Pedal accessory); or - Press the Left Foot Pedal (Double Pedal accessory). Review frames recorded during the exam by pressing ← and → on the keyboard or by moving the slider (below video display).
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Page 24: Performing Ubm Scans
PERFORMING UBM SCANS WARNING: Contact between the moving transducer element and the eye may result in injury. When performing a UBM procedure, the user must visually gauge the distance of the transducer to the cornea and ensure that a safe distance between the two is maintained at all times. - Page 25 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 stop recording until prompted.
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Page 26: Reviewing B-Scan And Ubm Videos
REVIEWING B-SCAN AND UBM VIDEOS ADJUSTING SCAN IMAGES The Gain, Intensity, Contrast and Zoom controls (available on the right-hand side of the screen) can be used to enhance the quality of the image. These settings can be adjusted before, during or after a procedure. -
Page 27: Scan And Ubm Voice Controls
[ENTER] key or by a verbal command of “Hey Flex”. Voice control sensitivity can be adjusted in this menu as well. NOTE: To use the voice control feature, the computer running the Scanmate Flex software must have a connected (or integrated) microphone that is enabled. -
Page 28: Scan Screen
A-SCAN SCREEN The A-Scan Screen allows the user to perform A-Scan procedures and review the loaded patient’s A-Scan records Open File: To view A-Scan videos, measurements and records associated with the current patient, click the [OPEN FILE] button in the upper right-hand corner. -
Page 29: Performing A-Scans (Contact)
PERFORMING A-SCANS (CONTACT) WARNING: Exercise caution when coming into contact with a patient’s eye. To avoid potential injury, use minimal pressure when applying the probe or adjusting its position. Only make minor position adjustments while in contact with the eye. If significant position adjustment is necessary, remove the probe from the eye and then reapply. - Page 30 11. Once contact is achieved, it may be necessary to adjust the angle of contact to align the probe with the visual axis. To do this, ensure the center of the probe tip is in stationary contact with the center of the cornea. Then, slightly tilt the back end of the probe. As the angle of contact changes and the probe comes closer to aligning with the visual axis, the beep rate will increase.
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Page 31: Performing A-Scans (Immersion)
PERFORMING A-SCANS (IMMERSION) WARNING: Exercise caution when coming into contact with a patient’s eye. To avoid potential injury, use minimal pressure when applying the immersion shell or adjusting its position. Only make minor position adjustments while in contact with the eye. If significant position adjustment is necessary, remove the probe from the eye and then reapply. - Page 32 11. Rest the palm of the hand holding the immersion shell on the patient’s forehead to reduce shell pressure on the eye. This position allows the palm to act as a pivot point for the shell. If necessary, the operator can stabilize the shell with the other hand and make micro- adjustments.
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Page 33: Alignment Ranking System
ALIGNMENT RANKING SYSTEM In Automatic Measurement Mode, the Scanmate Software uses a pattern recognition algorithm to determine when the probe is properly aligned. The alignment algorithm first looks for the proper pattern of reflectance peaks from each expected interface. Then the algorithm examines the retinal spike for particular signal characteristics which are produced only by retinal interfaces. -
Page 34: Reviewing A-Scan Videos And Measurements
REVIEWING A-SCAN VIDEOS AND MEASUREMENTS REVIEW WAVEFORM VIDEOS Waveform videos captured during the exam can be reviewed frame by frame by pressing the ← and → keys on the keyboard or by moving the slider along the bottom of the screen. If the currently displayed frame is associated with a measurement in the bank, the corresponding entry in the measurement bank will be highlighted. -
Page 35: Scan Voice Controls
[ENTER] key or by a verbal command of “Hey Flex”. Voice control sensitivity can be adjusted in this menu as well. NOTE: To use the voice control feature, the computer running the Scanmate Flex software must have a connected (or integrated) microphone that is enabled. NOTE: If the [ENTER] key is not configured to initiate a voice command, pressing it while on the A-Scan Screen will automatically save a measurement file. -
Page 36: Iol Calculator Screen
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 Screen. Information from the Patient Data screen, (Patient Name, ID, Doctor) will be imported into the IOL Calculator. -
Page 37: Performing Iol Calculations
NOTE: 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 38: Iol Formula References
IOL FORMULA REFERENCES The following IOL Power Calculation formulas are included in the Scanmate IOL Calculator. The formulas selected for inclusion are commonly used, and have been refined from earlier models. IOL power calculation formulas have evolved from the first models to become more accurate in a wider range of cases;... -
Page 39: Post Refractive Calculations
POST REFRACTIVE CALCULATIONS NOTE: The corrected corneal power (Kcorr) calculated using the formulas described are NOT to be interpreted as a suggested or recommended corneal power on the part of DGH Technology, Inc. The calculated corrected corneal power (Kcorr) should be used as a guideline only. -
Page 40: Post Refractive Formulas
Once calculated, results will automatically be imported into the IOL Calculator Screen and used for IOL Power Calculations. Selecting the [OK] button without calculating will close the calculator and save the values entered, but will not import a Kcorr to the IOL Calculator. - Page 41 REFRACTION DERIVED This method is useful when the pre-operative K values are unknown, but the pre-operative spectacle refraction is known. S.E. S.E. − post − post 0.23 corr − − S.E. S.E. post Required Inputs: Pre Refractive Surgery Spectacle Refraction (S.E.)
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Page 42: Personalized Lens Constants
PERSONALIZED LENS CONSTANTS WARNING: Only A-Scan measurements performed with the Scanmate Flex should be used to calculate personalized lens constants. WARNING: Only stabilized post operative results should be used to calculate personalized lens constants. WARNING: Corneal power measurements used for calculating personalized lens constants should be performed using the same keratometer. - Page 43 After a large population of results has been acquired for a given doctor and IOL model, navigate to the Personalized Lens Constants Table to view the Procedures that were performed by the selected doctor using the selected lens. Review the Procedures that have “Use Record”...
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Page 44: Exporting And Importing Data
EXPORTING AND IMPORTING DATA Individual measurement and video files can be exported and imported from the database to be consulted in other locations or by other practitioners. The Scanmate software must be installed on a computer to view measurement or video files. EXPORT A-SCAN MEASUREMENT FILE Select File >... -
Page 45: Database Management-Sql Server Database Backup
DATABASE MANAGEMENT—SQL SERVER DATABASE BACKUP If a Client PC installation was performed, an SQL Server database is used to store patient records. Electronic records should be backed up regularly to prevent data loss. To backup the Scanmate database using the Backup / Restore tool: Open the Back Up / Restore window by selecting File >... -
Page 46: Cleaning And Disinfection
WARNING: Probes and cables should not be autoclaved or subjected to intense heat. WARNING: DGH Technology, Inc. makes no claims about the biological effectiveness as a disinfectant of any of the products/solutions listed below. Furthermore, DGH Technology, Inc. - Page 47 USB INTERFACE MODULE (FLEX-USBIM)—GENERAL CLEANING CAUTION: The USB interface housing is not water tight. Do not saturate or immerse the housing in liquid. The USB Interface Module’s plastic housing can be cleaned using a soft cloth dampened with 70% (v/v) Isopropyl Alcohol. A-SCAN PROBE (DGH6006)—GENERAL CLEANING AND DISINFECTION CAUTION: Do not submerge the A-Scan probe in liquid beyond the cord strain relief.
- Page 48 UBM PROBE (DGH1500) AND TRANSDUCERS (1500-35, 1500-50)—GENERAL CLEANING AND DISINFECTION CAUTION: Contaminants in tap water will corrode the metal surfaces of the UBM probe and transducer. Only use distilled, deionized or sterile water when cleaning. If tap water is inadvertently used, thoroughly rinse the probe using distilled, deionized or sterile water. CAUTION: Extreme care must be taken to avoid scratching or otherwise damaging the gold surface of the transducer.
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Page 49: Routine Maintenance-Physical Inspection
Inspection of the device and its accessories is required to identify wear or damage that may be the result of routine use or accidental misuse. If the device or one of its components looks compromised, contact DGH Technology, Inc. for information on replacement components. USB INTERFACE MODULE (FLEX-USBIM) The USB Interface Module should be routinely inspected for dents, cracks and other forms of damage. -
Page 50: Routine Maintenance-Verifying A-Scan Calibration
DEVICE CORDS (FLEX-PCABLE) All device cords (probe cords, power cords, USB cords, etc.) should be routinely inspected for bends, cuts, abrasions and other forms of damage. Cord connectors should be inspected for cracks, abrasions, deformation, damaged/bent pins, etc. A-SCAN PROBE (DGH6006) The A-Scan probe housing should be routinely inspected of cracks, splitting, dents, sharp edges, projections, deformation and other forms of damage. -
Page 51: Repairs And Customer Support
DGH Technology, Inc. Customers within the United States can contact DGH Technology, Inc. at the address and phone number listed below. Customers outside of the United States should contact an authorized DGH distributor to arrange service/repair. - Page 52 ULTRASONIC EMMISSIONS INFORMATION The following Acoustic Output Reporting Tables show the average outputs of the samples tested. These results include the pressure-time waveform, the Fourier transform, the pulse in- tensity integral and the waveform analysis taken at the derated spatial peak location (z mjPII.3 The Statistical Analysis of Measurement Data tables show the results of a statistical analysis was performed on the data to examine the upper output limits, based on a one-sided tolerance limit...
- Page 53 ACCOUSTIC OUTPUT REPORTING TABLE Transducer Model: DGH6006 Operating Mode: A-Mode Index Label Non-Scan Non- Scan scan ≤1cm >1cm aprt aprt 0.133 6.72E-4 1.17E-3 (a) Maximum index value (MPa) 0.406 0.0151 0.0151 (mW) Min of [P ), I (mW) α ta,α (cm) (cm) Associated...
- Page 54 ACCOUSTIC OUTPUT REPORTING TABLE Transducer Model: DGH1912 Operating Mode: B-Mode Index Label Non-Scan Non- Scan scan ≤1cm >1cm aprt aprt 0.149 4.76E-3 Maximum index value (MPa) 0.524 0.0706 (mW) Min of [P ), I (mW) α ta,α (cm) (cm) Associated Acoustic (cm) parameter...
- Page 55 ACCOUSTIC OUTPUT REPORTING TABLE Transducer Model: DGH1920 Operating Mode: B-Mode Index Label Non-Scan Non- Scan scan ≤1cm >1cm aprt aprt 0.169 0.0112 Maximum index value (MPa) 0.640 0.163 (mW) Min of [P ), I (mW) α ta,α (cm) (cm) Associated Acoustic (cm) parameter...
- Page 56 ACCOUSTIC OUTPUT REPORTING TABLE Transducer Model: DGH1500-35 Operating Mode: B-Mode Index Label Non-Scan Non- Scan scan ≤1cm >1cm aprt aprt 0.177 1.43E-3 Maximum index value (MPa) 0.800 0.0147 (mW) Min of [P ), I (mW) α ta,α (cm) (cm) Associated Acoustic (cm) parameter...
- Page 57 ACCOUSTIC OUTPUT REPORTING TABLE Transducer Model: DGH1500-50 Operating Mode: B-Mode Index Label Non-Scan Non- Scan scan ≤1cm >1cm aprt aprt 0.113 4.44E-4 Maximum index value (MPa) 0.500 5.85E-3 (mW) Min of [P ), I (mW) α ta,α (cm) (cm) Associated Acoustic (cm) parameter...
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Page 58: Electromagnetic Immunity And Emissions
GUIDANCE AND MANUFACTURER’S DECLARATION ELECTROMAGNETIC IMMUNITY The Scanmate Flex is intended for use in the electromagnetic environment specified below. The customer or the user of the Scanmate Flex should assure that it is used in such an environment. Immunity Test IEC 60601... - Page 59 GUIDANCE AND MANUFACTURER’S DECLARATION ELECTROMAGNETIC IMMUNITY The Scanmate Flex is intended for use in the electromagnetic environment specified below. The customer or the user of the Scanmate Flex should assure that it is used in such an environment. Compliance Immunity Test...
- Page 60 GUIDANCE AND MANUFACTURER’S DECLARATION ELECTROMAGNETIC EMISSIONS The Scanmate Flex is intended for use in the electromagnetic environment specified below. The customer or the user of the Scanmate Flex should assure that it is used in such an environment. Emissions Test Compliance Electromagnetic environment –...
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Page 61: Environmental Conditions
70 kPa to 106 kPa When the Scanmate Flex is not being used, it should be stored in a clean, dry area. To prevent damage to the Scanmate Flex, do not store in areas where it might be exposed to excessive vibration, excessive dust and dirt, liquids or condensation or impact. -
Page 62: Troubleshooting Guide
TROUBLESHOOTING GUIDE UNABLE TO CONNECT—DGH DATABASE SERVER Error Message/Indicator: “Error while opening database” message. “An exception occurred while opening a report.” message. “Save unsuccessful.” message. “An exception occurred while testing the connection to the database. Error while opening database.” message. “Unable to update the procedure record in the database.”... - Page 63 If connecting the device does not reset the Probe Key, try the steps described in “USB Connection Not Detected” of this troubleshooting table. NEW PROBE KEY REQUIRED Error Message/Indicator: “Enter the key for the given probe and then press save.” message Contact DGH Technology Inc. in order to request a new probe key.
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Page 64: Warranty
WARRANTY DGH Technology, Inc. warrants that new devices and the accompanying accessories (hereinafter called “Equipment”) are to be free from defects in material and workmanship according to the warranty certificate provided with the equipment at the time of purchase. Warranties do 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.
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