Sonomed VuPad Operator's Manual
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Sonomed VuPad Operator's Manual

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OPERATOR'S MANUAL

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  • Page 1 OPERATOR’S MANUAL...

  • Page 2: Table Of Contents

    CONTENTS OVEVIEW Description Indications for Use Contraindications GETTING STARTED System Components Unpacking Consideration When Joining Network Domain Opening Display and Set-Up A-SCAN Patient Database Exam Mode Verify Calibration Exam Mode Calculation Mode Reports DIAGNOSTIC A-SCAN PACHYMETRY Select Exam Mode Perform Exam Report B-SCAN AND UBM Configure System...
  • Page 3 There are no user-serviceable parts within the VuPad system. To receive a translated copy of this manual, contact your in-country distributor, or call Sonomed directly at 516-354-0900 or 800-227-1285. For technical service and support please contact Sonomed Escalon or your local distributor. Document No. 5575-1901-E, Aug 2019...

  • Page 4: Description

    The VuPad™ is a stand-alone system that runs on a Windows 10 platform and may be networked (by the user) for interface with electronic medical records systems, printing, and other purposes.

  • Page 5: Indications For Use

    Common conditions such as glaucoma, iris cyst, neoplasms, trauma and foreign bodies can be accurately identified INDICATION FOR USE The VuPad™ is intended to be used to visualize and measure the eye and orbit using B-Scan and A-scan ultrasound. CONTRAINDICATIONS...

  • Page 6: Getting Started

    GETTING STARTED SYSTEM COMPONENTS PROBES A-Probe 10 MHz B-Probe (12 or 20 MHz Probes) Water Path Probe (with 35 or 50 MHz Transducers) Foot Pedal Power Ethernet Power On/Off Cable...

  • Page 7: Unpacking

    CONSIDERATION WHEN JOINING TO NETWORK DOMAIN The Vupad uses Windows 10 and may be joined to (or removed from) a network domain. However, when doing so, it is required that the local user account is set up as a local administrator on the ultrasound system.

  • Page 8: Opening Display And Setup

    OPENING DISPLAY AND SETUP ① OPEN THE VUPAD PROGRAM by clicking on the VuPad Icon located on the desktop screen. ② CLICK ON THE “CONFIGURE” TAB. This will allow the user to set up defaults for the MD/Examiner by: * Select “New MD/Examiner” tab and complete the requested information for MD/Examiner using the on-screen keyboard (or optional external Bluetooth keyboard).
  • Page 9 Master Lens Database Tab Examiner Lens Selection Fig. 1 MD/Examiner Setup Display Name: Enter Examiner Name Type: Enter Examiner/Attending Phys./ Referring Phys. Default Examiner: A “default” examiner can be entered for every exam. NOTE: In order to perform A-scan biometry measurements, an “Attending”...
  • Page 10 Fig. 2 Lens Selection Screen: Manufacturer: Scroll and Select the Lens Manufacturer’s Name. Lenses: Scroll and Select the desired Lens Model. NOTE: The “Lens Database” Tab (see Fig.1) includes over 1500 lenses and associated data which the user can update, by adding, deleting or editing lenses.

  • Page 11: A-Scan

    A-SCAN PATIENT DATABASE ① PATIENT: Select the “NEW” tab located at the top left side of the database display screen. NOTE: For previously entered patient, scroll through patient list, by sliding the scroll indicator just to the right of patient list until the desired patient name is displayed.

  • Page 12: Verify Calibration

    The Verify Calibration Window should be displayed if the “Bio A” tab had been selected previously. - Select YES to perform the calibration verification. The VuPad will start emitting an audio “beeping”. Place a drop of water onto the face of the a-scan probe and press the probe onto the calibration cylinder (located on left side probe holder).
  • Page 13 Fig. 4 - The “CONTINUOUS CAPTURE” tab, if selected, will allow the user to set the desired number of scans that the VuPad will obtain with a single press of the footswitch. If “Immersion” mode has been selected, TWO footswitch presses would be required to begin obtaining scans –...

  • Page 14: Calculation Mode

    ③ Selecting the BIOMETRY tab, will permit the user to view all the data collected from the scan session including the ACD, LENS THICKNESS, VITREOUS DEPTH AND AXIAL LENGTH for all scans in the set. The user can omit a scan from being included in the Average by un- checking the “Enabled”...

  • Page 15: Reports

    REPORTS Once the REPORT tab is selected, the display will show the report template (see Fig. 5) which includes the A-scan(s) and IOL calculations for each eye for which the measurement/calculations were performed. If required, the user can return to the calculation tables, edit the lens and/or formula data and select the ADD TO REPORT tab again.

  • Page 16: Diagnostic A-Scan

    DIAGNOSTIC A-SCAN MODE ① Power ‘On’ System: By pressing the front panel power switch located on the bottom right side of the unit’s front panel. ② Starting Application: From Windows desktop, double click on the ‘VuMaxHD Software’ icon (Fig. 6). Fig.
  • Page 17 ⑤ Application Window: Upon selecting the ‘Diagnostic-A Utility’ button the VuMAX HD patient database will momentarily close and the Diagnostic A-Scan Utility screen will open (Fig. 9). Fig. 9 - Diagnostic-A Utility Screen ⑥ Begin Scan, Stop Scan and Save: To commence a live scan, select the ‘Begin Scan’...
  • Page 18 ‘Close and Return’ button to return to the VuMax HD Patient Database screen. ⑨ Calibration: Clicking on the Sonomed Escalon logo while having the control key pressed, it will pop up the S curve calibration as in Fig.12.

  • Page 19: Pachymetry

    PACHYMETRY SELECT EXAM MODE ① EXAM: Select the “NEW” tab located at the top right side of the database display screen. ② Verify Examiner [Required], Attending Phys [Required], and Referring Phys (if needed) are entered. ③ ENTER THE EXAM TYPE [Pach] and Laterality [OD/OS]. [If the exam is to be used as a teaching case, place a checkmark in the box labeled “Teaching Case”].
  • Page 20 ① Select desired exam mode option: (Fig 13 and 14) Single Point | Single Reading Provides for a single reading at a single point on cornea. Single Point | Multiple Readings Proides for up to 5 readings at a single point on cornea. Multiple Points | Single Reading Provides for a single reading at up to 9 points on cornea.

  • Page 21: Report

    REPORT ① Select “Report” button to generate pachymetry report (Fig. 15). Fig 15...

  • Page 22: B-Scan And Ubm

    Diagnoses tab and selecting the <New Diagnosis> tab. PATIENT DATABASE Upon opening the VuPad program, the home screen shown is the patient database, which shows a history of patients and their respective exams. From this screen, several functions can be performed: ①...
  • Page 23 ④ SELECT PATIENT by highlighting the patient from the patient list – a history of any saved exams for the patient will appear in the exam list. ⑤ SELECT EXISTING EXAM by double-clicking on an exam record for a particular patient. This function opens the exam and displays associated images (see EXAM RECORD section of this user manual).

  • Page 24: Exam Mode

    EXAM MODE After selecting the <New Exam> button from the Patient Database screen, enter the exam information, the Exam screen is shown from which imaging can be performed. ① SELECT THE PROBE FREQUENCY to be used from the drop-down menu and select the <Refresh Probes>...
  • Page 25 ANNOTATIONS Angle Measurement places adjustable angle edges onto image and displays angle in degrees. Arbitrary A-Scan allows user to see an A-scan trace along any vector. Linear Measurement places adjustable calipers onto image and displays distance. Pan allows user to move image while holding down the left mouse button.
  • Page 26 IMAGE CONTROLS Time Variable Gain (TVG) attenuates near field portion of scan sector. Baseline Affects low-level signal threshold to help reduce noise. Zoom Adjusts area of scan sector display on monitor. Log Gain Adjusts overall amplification of received signal. Adjusts overall signal amplitude in image with minimal effect Exp Gain on low-level noise (otherwise known as “E-Gain”).

  • Page 27: Maintenance

    MAINTENANCE SYSTEM CLEANING Clean the VuPad™ probes with a damp cloth to remove gel and other debris. Use appropriate products to clean the cabling and foot pedals as necessary. WARNING: Disconnect the AC POWER before cleaning the system. PROBE CLEANING AND DISINFECTION The probe must be cleaned and disinfected between patients to prevent patient-to-patinet transmission of infection.
  • Page 28 The probe is hermetically sealed and, if necessary, the entire probe (up to the connector) may be immersed in either disinfecting solution (70% IPA or hydrogen peroxide). However, this should be reserved for rare cases where it is judged by the clinician that the entire probe has been contaminated.
  • Page 29 blot with a soft, lint-free cloth or gauze. If not used immediately, the probe may be placed in a clean bag for storage. The probe is hermetically sealed and, if necessary, the entire probe (up to the connector) may be immersed in either disinfecting solution (70% IPA or hydrogen peroxide).
  • Page 30 TECHNICAL SERVICE AND SUPPORT There are no user-serviceable parts within the system. Please contact Sonomed Escalon or your local distributor to request technical service and support. Technical support 800-227-1285 or 516-354-0900.

  • Page 31: Specifications

    SPECIFICATIONS A-SCAN SPECIFICATIONS Ultrasound Sealed 10 MHz focused transducer with standard probe Probes (max length 5 ft cord) Scan Modes Direct contact or immersion Manual or automatic capture (cataract, dense cataract, aphakic, and pseudophakic) Measurements Anterior depth (ACD), lens thickness, vitreous, and axial length (AXl) Averages and standard deviation calculated for up to 10 scans per exam...

  • Page 32: Pachymeter Specifications

    UBM / B-SCAN SPECIFICATIONS (cont’d) Preset Scan UBM: Selectable preset scan setting profiles to optimize image Settings quality for each frequency probe: high resolution, sulcus-to-sulcus, angle detail, and motion picture 2D Scan 256 ray scan with 2048 sample points for each ray (524,288 Sampling sample points per sweep) 2D Video Clips...

  • Page 33: General Specifications

    GENERAL SPECIFICATIONS Patient Exam Searchable patient database with exam record storage and Records expanded field set User Profiles Add unlimited number of users with user-selectable defaults and denotation of attending physician, referring physicians, and/or examiner Reports Detailed exam reports for printing or exporting Export Feature Export images (.jpg), video clips (.avi), and exam reports (.pdf) Display...

  • Page 34: Alara And Emissions

    ALARA SECTION AND EMISSIONS (“As Low As Reasonably Achievable”) STATISTICAL ANALYSIS OF MEASURED DATA A statistical analysis was performed on the data to examine the upper output limits based on a one-sided tolerance limit approach. The mean and standard deviation of the Spatial-Peak, Time-Average Intensity and Mechanical Index were found, and the upper output limits were calculated from the following formula: X = x +K*Sx...
  • Page 35 Probe 35 MHz Transducer 50 MHz Transducer Mode B-Mode (UBM) B-Mode (UBM) Material Gold-plated polymer Gold-plated polymer membrane membrane Nominal Center 35 MHz 50 MHz Frequency Pule Repetition 2560 Hz 2560 Hz Frequency Type B-Scan B-Scan (energy emitted during active (energy emitted during active scan) scan)
  • Page 36 Probe 10 MHz (A-Scan) Transducer Mode A-Mode Material Lead Metaniobate Nominal Center Frequency 10 MHz Pule Repetition Frequency 5880 Hz Type A-Scan (energy emitted during active scan) Measure SPTA.3 [no units] [mW/cm Sample Size 4.258 4.258 Mean 0.186 7.82 Standard .00458 0.570 Deviation...
  • Page 37 ACOUSTIC OUTPUT REPORTING TABLES FOR TRACK 1: AUTO SCANNING MODE Note: Track 1 Reporting Tables show the worst-case indices for each probe type and operating conditions that must be reported. Sonomed Escalon 10 MHz Probe Transducer Model (s/n D09A655) Operating Mode...
  • Page 38 Sonomed Escalon 20 MHz Probe Transducer Model (s/n 22160) Operating Mode B-Mode Application Ophthalmic SPTA.3 SPPA.3 Acoustic Output [no units] [mW/cm [W/cm Global Maximum Value 0.122 0.184 11.5 Associated Pr.3 [Mpa] 0.456 [mW] 0.0296 0.003 Acoustic [MHz] 14.0 14.0 14.0...
  • Page 39 Sonomed Escalon 50 MHz Transducer Transducer Model (s/n 50-00376) Operating Mode B-Mode Application Ophthalmic SPTA.3 SPPA.3 Acoustic Output [no units] [mW/cm [W/cm Global Maximum Value 0.019 0.001 0.190 Associated Pr.3 [Mpa] 0.112 [mW] 0.0003 0.0003 Acoustic [MHz] 34.168 34.168 34.168...

  • Page 40: Immunity Test Levels

    IMMUNITY TEST LEVELS Electrostatic Discharge Air Discharge Voltage: 2.0 kV, 4.0 kV, 8.0 kV, 15.0 kV Contact Discharge Voltage: 2.0 kV, 4.0 kV, 8.0 kV Radiated Immunity, 8 0 MHz to 2.7 GHz and Proximity Fields Radiated Immunity, Test Parameters Frequency Range 80 to 1000 MHz 1.0 to 2.7 GHz...
  • Page 41 VOLTAGE DIPS AND INTERRUPTS 100 VAC 60 Hz Voltage Voltage Test Rated Frequency Test Duration Specification Voltage Result Voltage (Hz) Level (Periods) (Vac) 0% UT for 0.5 0.5 Cycle Cycles @ 0° 0% UT for 0.5 0.5 Cycle Cycles @ 45° 0% UT for 0.5 0.5 Cycle Cycles @ 90°...
  • Page 42 220 VAC 60 Hz Voltage Voltage Test Rated Frequency Test Duration Specification Voltage Result Voltage (Hz) Level (Periods) (Vac) 0% UT for 0.5 0.5 Cycle Cycles @ 0° 0% UT for 0.5 0.5 Cycle Cycles @ 45° 0% UT for 0.5 0.5 Cycle Cycles @ 90°...
  • Page 43 240 VAC 50 Hz Voltage Voltage Test Rated Frequency Test Duration Specification Voltage Result Voltage (Hz) Level (Periods) (Vac) 0% UT for 0.5 0.5 Cycle Cycles @ 0° 0% UT for 0.5 0.5 Cycle Cycles @ 45° 0% UT for 0.5 0.5 Cycle Cycles @ 90°...
  • Page 44 GUIDANCE AND MANUFACTURER’S DECLARATION The VuPad is intended for use in the electromagnetic environment specified below. The customer or user of the VuPad should ensure that it is used in such an environment. Electromagnetic Environment Emissions Test Compliance Guidance Radiated...
  • Page 45 The VuPad is intended for use in the electromagnetic environment specified below. The customer or user of the VuPad should ensure that it is used in such an environment. Immunity 60601 Compliance Electromagnetic Environment Test Test Level Guidance Level Conducted RF...
  • Page 46 To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the VuPad is used exceeds the applicable RF compliance level above, the VuPad should be observed to verify normal operation.

  • Page 47: Warnings And Cautions

    DO NOT attempt to repair or service this instrument. Any repair or service to this instrument must be performed by experienced personnel who are trained by Sonomed Escalon. Attempts to repair or service the instrument may result in serious injury to the operator or patient.
  • Page 48 Never autoclave a transducer or expose it to high heat. Do not attempt to connect the device to any accessories or supplemental equipment other than that provided by Sonomed Escalon. This could result in increased electromagnetic emissions or decreased electromagnetic immunity and result in improper operation.
  • Page 49 50 Hz and 60 Hz, but it is recommended that use in close proximity to or stacking of other electronic devices should be avoided because it could result in improper operation. If such use is necessary, the VuPad and other equipment should be observed to verify normal operations.

  • Page 50: Cyber Security Recommendations

    CYBER SECURITY RECOMMENDATIONS VuPad systems incorporate Microsoft 10 as the software Operating System, and, as such, makes available to Operators the full scope of Microsoft Windows 10 security features as defense against cyber security threats. Failure to maintain cyber security could result in compromised device functionality, loss of data availability or integrity, or exposure of other connected devices or networks to security threats.
  • Page 51 To turn on automatic updating: Open Windows Update by swiping in from the right edge of the screen (or, if using a mouse, pointing to the lower-right corner of the screen and moving the mouse pointer up), tapping or clicking Settings, tapping or clicking Control Panel, and then tapping or clicking Windows Update.

  • Page 52: Warranty

    WARRANTY Sonomed Escalon warrants its products are free of defects of labor and material for two (2) years for consoles, one (1) year for probes and cables, and one (1) year for associated computer components such as monitors, keyboards, and mice.
  • Page 53 NETWORKING Sonomed Escalon does not provide support for the operation of this product in a network environment. Connection to and operation on any network is entirely the responsibility of the user. Where installation or use of any network hardware or software interferes with the normal operation of this Sonomed Escalon-supplied product, that product must be returned to normal operation at the user’s expense.

  • Page 54: Symbols

    IPX7 (Note: Rating Applies to Ultrasound Probes Only) Do not immerse probe electrical connectors. Rating applies to VuPad Base Unit only. An IPX1 designation IPX1 means the device enclosure is resistant to the ingression of water at a flow rate of 1mm/min for 10 minutes.

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