Wallach Surgical Devices SummitDoppler Vista ABI User Manual
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Wallach Surgical Devices SummitDoppler Vista ABI User Manual

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User Manual for Vista ABI
TM
REF
L450VA (with Stand and Basket)
L450VANS (Stand and Basket not included)
MAN0024-DFU • Rev. A • 5/13
Wallach Surgical Devices

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Summary of Contents for Wallach Surgical Devices SummitDoppler Vista ABI

  • Page 1 User Manual for Vista ABI L450VA (with Stand and Basket) L450VANS (Stand and Basket not included) MAN0024-DFU • Rev. A • 5/13 Wallach Surgical Devices...

  • Page 2: Table Of Contents

    Section 14: Accessories ..................41 Section 15: Troubleshooting Guide ............... 42 Section 16: Clinical References ................43 Section 17: AVS Report Software ..............44 Section 18: Warranty....................60 Section 19: Explanation of Symbols ..............61 MAN0024-DFU • Rev. A • 5/13 Wallach Surgical Devices...

  • Page 3: Introduction

    Prior to filing any claims, customers are advised to contact their third-party payers for specific coverage, coding and payment information. Wallach Surgical Devices makes no promise or guarantee of reimbursement by Medicare or any other third-party payer.

  • Page 4: Safety Information

    Connected equipment must be certified to the applicable IEC standard (i.e. IEC 950 for data processing equipment, IEC 60601-1 for medical equipment). Contact the technical service department for more information. MAN0024-DFU • Rev. A • 5/13 Wallach Surgical Devices...
  • Page 5 MAN0024-DFU • Rev. A • 5/13 Wallach Surgical Devices...
  • Page 6 In those special situations in which examinations are to be carried out for purposes other than direct medical benefit to the individual being examined, the subject should be informed of the anticipated exposure conditions, and of how these compare with conditions for normal diagnostic practice. MAN0024-DFU • Rev. A • 5/13 Wallach Surgical Devices...

  • Page 7: Description Of Product And Controls

    Since blood attenuates IR light at a higher level than the surrounding tissue, the signal’s pulse contours are determined by the arterial blood supply. This type of PPG system is primarily for arterial pulse detection. MAN0024-DFU • Rev. A • 5/13 Wallach Surgical Devices...
  • Page 8 FEED - Printer feeds paper while pressed CHARGING - On: Charging - Flashing: Charging complete (trickle charging while flashing) LOW BATT - Flashing: Low battery PAPER RELEASE - Blue button under paper dispenser: Opens printer cover MAN0024-DFU • Rev. A • 5/13 Wallach Surgical Devices...
  • Page 9 - Frozen waveform- Starts new waveform acquisition - Moves the protocol marker to SITE the next location SITE - Saves data before leaving old protocol location - Changes the waveform scaling SCALE SCALE MAN0024-DFU • Rev. A • 5/13 Wallach Surgical Devices...
  • Page 10 S, T, U Numeral 9 V, W, X Numeral 0 Y, Z Space Space SPACE Hyphen Hyphen See Section 5 for information on how to change between character and numeral modes. MAN0024-DFU • Rev. A • 5/13 Wallach Surgical Devices...

  • Page 11: Preparation For Use

    Plug the external power supply into the + 7 VDC (Power) connector. VISTA TIP • For first time use, allow the unit to charge for at least one hour before operating the Vista ABI from its battery. MAN0024-DFU • Rev. A • 5/13 Wallach Surgical Devices...
  • Page 12 To maintain patient safety, it is not possible to conduct an examination while the Vista ABI is connected to a PC via the USB port. Connectors Doppler Hand + 7 VDC (Power) Cuff Controller MAN0024-DFU • Rev. A • 5/13 Wallach Surgical Devices...

  • Page 13: Menu Configuration And Set Up

    4 – TBI with Doppler Waveform NOTE: Options 5 and 6 are not 5 – Segmental with PVR Waveform available for use with the Vista 6 – Segmental with Doppler Waveform ABI system. MAN0024-DFU • Rev. A • 5/13 Wallach Surgical Devices...
  • Page 14 If there is flickering or shadowing on the text, the contrast is adjusted too high. Readjust contrast level by pressing the number 2 key until contrast level starts over at 1 and slowly increase the contrast level MAN0024-DFU • Rev. A • 5/13 Wallach Surgical Devices...
  • Page 15 4. To enter a filename, use the alphanumeric keys on the hand-held controller. Use the key to backspace and the key to move between different letters on the same DOWN button. 5. Press the key to save the filename and begin the exam. SAVE MAN0024-DFU • Rev. A • 5/13 Wallach Surgical Devices...
  • Page 16 PPG mode. To change the setting, go to the System Settings menu and select Doppler for obtaining pressures and waveforms. MAN0024-DFU • Rev. A • 5/13 Wallach Surgical Devices...
  • Page 17 (the ENTER ENTER/MENU FILENAME will appear), or press the key to save the data and the SAVE FILE menu SAVE will appear. MAN0024-DFU • Rev. A • 5/13 Wallach Surgical Devices...

  • Page 18: The Ankle Brachial Index (Abi) Examination

    Notice that the patient’s right hand side is shown on the left side of the Vista • ABI's screen in order to match what you see when you face the patient. MAN0024-DFU • Rev. A • 5/13 Wallach Surgical Devices...
  • Page 19 SAVE the R-BRA protocol location. This is the systolic pressure. In general, the audible Doppler signal is a slightly more sensitive indicator of the systolic pressure than the Doppler waveform display. MAN0024-DFU • Rev. A • 5/13 Wallach Surgical Devices...
  • Page 20 20 mmHg above the pressure until the PPG pulsations disappear. The arm cuff will begin to deflate automatically once the pump stops. MAN0024-DFU • Rev. A • 5/13 Wallach Surgical Devices...
  • Page 21 SAVE (PT, DP, TOE, BRA, ***). Press again to store these values and move to the SITE SAVE R-ANK (right ankle) location. MAN0024-DFU • Rev. A • 5/13 Wallach Surgical Devices...
  • Page 22 Vista ABI automatically deflates or bleeds the cuff at the After releasing the PUMP correct rate. Press the key at the moment flow returns to store ankle pressure value in SAVE the R-ANK location. MAN0024-DFU • Rev. A • 5/13 Wallach Surgical Devices...
  • Page 23 Move the cuff hose to the left ankle cuff and repeat the procedure described for the right ankle on the left ankle. When the left ankle pressure is stored in the L-ANK site, the site cursor moves to L-BRA (left brachial pressure) site. MAN0024-DFU • Rev. A • 5/13 Wallach Surgical Devices...
  • Page 24 Moderate Disease 0.00 to 0.40 Severe Disease See Section 9 for File Management information including saving, printing, recalling patient data, and for information on how to reset for new patient data. MAN0024-DFU • Rev. A • 5/13 Wallach Surgical Devices...

  • Page 25: The Toe Brachial Index (Tbi) Examination

    PPG probe to the distal phalanx with the blue side of the probe against the skin as shown in the photos below. NOTE: The ankle cuff is not used while taking toe pressures. MAN0024-DFU • Rev. A • 5/13 Wallach Surgical Devices...
  • Page 26 The Vista ABI automatically calculates the toe brachial index (TBI) for both sides. The right and left TBI are both calculated using the higher of the two brachial pressures. TBI Assessment Above 0.70 Normal 0.64-0.70 Borderline Below 0.64 Abnormal MAN0024-DFU • Rev. A • 5/13 Wallach Surgical Devices...

  • Page 27: The Seated Abi Examination

    While holding the probe steady on the artery, press and hold key to about 20 mmHg above the occlusion pressure. Release the key and PUMP PUMP the cuff will automatically start to deflate. MAN0024-DFU • Rev. A • 5/13 Wallach Surgical Devices...
  • Page 28 The PPG probe is not suitable for obtaining pressures in the seated position. The Doppler probe is available and recommended. • The two pressure modes, high or low, are not available while performing the Seated ABI. MAN0024-DFU • Rev. A • 5/13 Wallach Surgical Devices...

  • Page 29: File Management

    SAVE ENTER/MENU automatically complete the save function before the power is turned off. NOTE: Powering off by unplugging the system will not activate this feature. MAN0024-DFU • Rev. A • 5/13 Wallach Surgical Devices...
  • Page 30 ABIs will print. The printout will show 4 seconds of recorded waveform data although the display only shows 3 seconds. NOTE: It is not possible to print directly from the FILE menu. MAN0024-DFU • Rev. A • 5/13 Wallach Surgical Devices...
  • Page 31 DOWNLOAD ALL and DOWN pressing the key. ENTER/MENU VISTA TIP: • This mode is useful to help expedite downloads of saved files by eliminating the need to recall the file first. MAN0024-DFU • Rev. A • 5/13 Wallach Surgical Devices...

  • Page 32: Section 10: Peripheral Arterial Waveform Interpretation

    Above is a waveform with the characteristics of abnormal PT flow. The acceleration and deceleration times are slow, the diastolic components are absent, and the waveforms have a somewhat diminished height. These waveforms are typical of a patient with mild to moderate arterial disease. MAN0024-DFU • Rev. A • 5/13 Wallach Surgical Devices...
  • Page 33 Normal waveforms usually have a dicrotic notch between the peak and baseline. However, the dicrotic notch may become less noticeable with vasodilation or may become more pronounced during vasoconstriction. MAN0024-DFU • Rev. A • 5/13 Wallach Surgical Devices...
  • Page 34 PPG is useful for obtaining pressures as described in Section 7. Toe pressures obtained with PPG meet reimbursement criteria if accompanied by either Doppler or PVR waveforms. For these reasons, Wallach Surgical Devices recommends using PVR and Doppler modes for waveform analysis. MAN0024-DFU • Rev. A • 5/13...

  • Page 35: Section 11: Maintenance And Cleaning

    U.S. Environmental Protection Agency (EPA). Clorox Broad Spectrum Quaternary Disinfectant is the only disinfectant that is Wallach Surgical Devices approved for use with the Vista products. Follow the instructions provided with the disinfectant and be sure to wipe the unit dry when finished.
  • Page 36 In order to preserve, protect and improve the quality of the environment, protect human health and utilize natural resources prudently and rationally – do not dispose of waste electrical or electronic equipment (WEEE) as unsorted municipal waste. Contact local WEEE disposal sites. MAN0024-DFU • Rev. A • 5/13 Wallach Surgical Devices...

  • Page 37: Section 12: Battery Recharging And Replacement

    NOTE: Charging will not begin if the battery temperature is less than 0  C (32  F). NOTE: It is important not to unplug the Vista ABI from the wall during an exam. This may result in system reset. MAN0024-DFU • Rev. A • 5/13 Wallach Surgical Devices...
  • Page 38 The battery pack contains a temperature measurement component that is matched to the cell type and to the product requirements. Use only replacement battery packs as specified by Wallach Surgical Devices. • Unauthorized battery substitutions will void the warranty and may cause overheating.

  • Page 39: Section 13: Specifications

    Available Probe Frequencies: 8.43 MHz, 5.5 MHz Displayed Waveform Amplitude Accuracy: ±10% Speaker Output: > 0.25 W Speaker Type: 2", 5 W Cable length: 6.5 ft Volume Control: Continuously variable with mute MAN0024-DFU • Rev. A • 5/13 Wallach Surgical Devices...
  • Page 40 Thermal, Product Number #K180 Adhesive Backed Label or Thermal, Archival, 58 mm CAUTION • Use only the specified paper supplied by Wallach Surgical Devices. Use of improper paper may damage the print mechanism. Data Storage and Transfer: Storage: 10 storage locations, 16 numeric or 24 alpha character length filenames Type: USB 2.0...
  • Page 41 Vista ABI and its External Power Supply are a medical system. The External Power Supply must meet IEC60601-1 construction requirements for Reinforced Insulation at minimum in order for the system to comply with the appropriate safety standards. Attention: Consult Accompanying Documents MAN0024-DFU • Rev. A • 5/13 Wallach Surgical Devices...
  • Page 42 < 112 mW/cm Note that parameter z (in the probe reporting tables) is the same parameter as I in IEC 61157. Operating Conditions: There are no user controls which affect the ultrasound output. MAN0024-DFU • Rev. A • 5/13 Wallach Surgical Devices...

  • Page 43: Section 14: Accessories

    SECTION 14: Accessories The following accessories and replacement items are available from Wallach Surgical Devices. Contact us at 1-800-243-2463 or (203) 799-2000, or order on-line at www.wallachsurgical.com. Packages PPG Package – includes PPG probe & digit cuff L450PG AVS Software Package – PC download capability...

  • Page 44: Section 15: Troubleshooting Guide

    SECTION 15: Troubleshooting Guide Troubleshooting: WARNINGS: • Use alternate equipment in case of unit failure. Call Wallach Surgical Devices’ Service Department if the unit or probes malfunction. Risk of Electric Shock - the Vista ABI contains no user serviceable components. •...

  • Page 45: Section 16: Clinical References

    Intermittant Claudication, Hillsborough, NJ: Excerpta Medica, Inc., A Reed Elsevier Co. General Information about P.A.D: National Institute of Health (NIH) Stay in Circulation Campaign: www.aboutpad.org P.A.D. Coalition: www.padcoalition.org The Vascular Disease Foundation (VDF): www.vdf.org MAN0024-DFU • Rev. A • 5/13 Wallach Surgical Devices...

  • Page 46: Section 17: Avs Report Tm Software

    Operating system supported only with a 64 or 32-bit Windows 7 Home Premium or ® ® better, a 32-bit Windows XP Professional, and a 32-bit Windows Vista Home Premium or better. MAN0024-DFU • Rev. A • 5/13 Wallach Surgical Devices...
  • Page 47 NOTE: The standard installation does not include DICOM formatted file option. If you need the DICOM feature, contact Wallach Surgical Devices to obtain the new software disk at (203) 799-2000 or 1-800-243-2463. To install the DICOM feature, contact Wallach Surgical Devices.
  • Page 48 USB Port on the PC. Once the cable is connected to both devices, turn on the Vista ABI . When the computer successfully recognizes the device, the following message will appear: MAN0024-DFU • Rev. A • 5/13 Wallach Surgical Devices...
  • Page 49 On the Vista ABI OPTIONS menu, select FILE and DOWNLOAD to transfer data that is currently active. The AVS Report software will briefly indicate “Upload Success” to verify that the data was accepted. MAN0024-DFU • Rev. A • 5/13 Wallach Surgical Devices...
  • Page 50 Check to ensure the USB cable is securely connected on both ends and download the file again. Contact Wallach Surgical Devices if the error continues to occur. Report data is segmented into 4 Sections of the software and separated by tabs at the top of the application.
  • Page 51 Pressure/ABI Tab along with the modality used to take the pressures, Doppler or PPG. A reference table is also displayed for either ABI or TBI clinically accepted values as an aid for the clinician in determining a diagnosis. MAN0024-DFU • Rev. A • 5/13 Wallach Surgical Devices...
  • Page 52 ABI Exam Arm and Ankle Pressures Reference ABI Table ABI Value Modality Seated ABI Exam Arm and Ankle Pressures Reference ABI Table Hydrostatic Correction Modality MAN0024-DFU • Rev. A • 5/13 Wallach Surgical Devices...
  • Page 53 Select the tabs at the bottom of the page to choose either CPT or ICD-9. Select the appropriate code on each screen or type a code in the “Other” section if the desired code is not available. Only one selection can be valid on any given report. MAN0024-DFU • Rev. A • 5/13 Wallach Surgical Devices...
  • Page 54 Allows the user to view the completed report prior to printing. Zoom in and out, scroll pages or print directly from the preview window. Printer Select: Allows the user to change the default printer. Exit: Allows the user to exit the application. MAN0024-DFU • Rev. A • 5/13 Wallach Surgical Devices...
  • Page 55 Enter the information in the fields and click “OK”. physician names to be used for referring or interpreting physician on the patient information tab. Select “Add” to enter a new name. MAN0024-DFU • Rev. A • 5/13 Wallach Surgical Devices...
  • Page 56 There are three file export types that are supported: Adobe PDF, DICOM and Comma Delimited files (.csv). NOTE: The saved files will default directly into the folder initially created in the File Path menu to store the AVS Report software. MAN0024-DFU • Rev. A • 5/13 Wallach Surgical Devices...
  • Page 57 DICOM viewing applications. As these standards are constantly evolving, all efforts have been made to verify the DICOM files and data elements conform to the latest published DICOM standards for this SOP Class. MAN0024-DFU • Rev. A • 5/13 Wallach Surgical Devices...
  • Page 58 Completed Sample ABI Report in PDF File Format MAN0024-DFU • Rev. A • 5/13 Wallach Surgical Devices...
  • Page 59 Completed Sample Seated ABI Report in PDF File Format MAN0024-DFU • Rev. A • 5/13 Wallach Surgical Devices...
  • Page 60 Completed Sample Segmental Study Report in PDF File Format MAN0024-DFU • Rev. A • 5/13 Wallach Surgical Devices...
  • Page 61 St. Joseph HospitalAddr 1234 Main Golden SummitAddr 4680 Table Mountain Drive #150 Golden, CO 80403 Phone: 303.423.7572 Fax: 303.940.7165 Toll Free: 800.554.5090 Examiner Kathy C. - RVT Modality Pressures – Doppler MAN0024-DFU • Rev. A • 5/13 Wallach Surgical Devices...

  • Page 62: Section 18: Warranty

    Wallach Surgical Devices disclaims all expressed or implied warranties, agreements or arrangements other than issued in this warranty. Wallach Surgical Devices is not responsible for damages to the device that occur as a result of the inadequate packaging on return shipments to Wallach Surgical Devices, improper...

  • Page 63: Section 19: Explanation Of Symbols

    , and Windows are registered trademarks of Microsoft Corporation in the United States and other countries. ® Adobe is a registered trademark of Adobe Systems Incorporated. © 2013 Wallach Surgical Devices MAN0024-DFU • Rev. A • 5/13 Wallach Surgical Devices...
  • Page 64 95 Corporate Drive Trumbull, CT 06611 USA Phone: 800-243-2463 (203) 799-2000 Fax: (203) 799-2002 customerservice@wallachsurgical.com www.wallachsurgical.com Made in the USA MAN0024-DFU • Rev. A • 5/13 Wallach Surgical Devices...

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