Related Manuals for Wallach Surgical Devices Summit Doppler Vista AVS L500VAC
Summary of Contents for Wallach Surgical Devices Summit Doppler Vista AVS L500VAC
- Page 1 User Manual for Vista AVS ® L500VA (with Stand and Basket) L500VAC (Stand and Basket not included) MAN0014-DFU • Rev. A • 5/13 Wallach Surgical Devices...
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Page 2: Table Of Contents
Section 16: Accessories ..................45 Section 17: Troubleshooting Guide..............46 Section 18: Clinical References................47 Section 19: AVS Report Software..............48 Section 20: Warranty ................... 64 Section 21: Explanation of Symbols..............65 MAN0014-DFU • Rev. A • 5/13 Wallach Surgical Devices... -
Page 3: Section 1: 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: Section 2: 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. MAN0014-DFU • Rev. A • 5/13 Wallach Surgical Devices... - Page 5 MAN0014-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. MAN0014-DFU • Rev. A • 5/13 Wallach Surgical Devices...
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Page 7: Section 3: Description Of Product And Controls
Light reflected from the underlying tissue is received by a detector and converted to an electrical signal. 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. MAN0014-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 MAN0014-DFU • Rev. A • 5/13 Wallach Surgical Devices...
- Page 9 - Frozen waveform- Starts new waveform acquisition - Moves the protocol marker to SITE SITE the next location - Saves data before leaving old protocol location - Changes the waveform scaling SCALE SCALE MAN0014-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. MAN0014-DFU • Rev. A • 5/13 Wallach Surgical Devices...
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Page 11: Section 4: Preparation For Use
6. Review the unit and locate each of the controls and connectors (see Section 3 and information on the next page). 7. Plug the external power supply into the + 7 VDC (Power) connector. MAN0014-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 AVS is connected to a PC via the USB port. Connectors Doppler Hand + 7 VDC (Power) Cuff Controller MAN0014-DFU • Rev. A • 5/13 Wallach Surgical Devices...
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Page 13: Section 5: Menu Configuration And Set Up
1 – ABI with PVR Waveform 2 – ABI with Doppler Waveform 3 – TBI with PVR Waveform 4 – TBI with Doppler Waveform 5 – Segmental with PVR Waveform 6 – Segmental with Doppler Waveform MAN0014-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 MAN0014-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 DOWN same button. 5. Press the key to save the filename and begin the exam. SAVE MAN0014-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. MAN0014-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. MAN0014-DFU • Rev. A • 5/13 Wallach Surgical Devices...
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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 AVS's screen in order to match what you see when you face the patient. MAN0014-DFU • Rev. A • 5/13 Wallach Surgical Devices... - Page 19 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. MAN0014-DFU • Rev. A • 5/13 Wallach Surgical Devices...
- Page 20 20 mmHg above the PUMP pressure until the PPG pulsations disappear. The arm cuff will begin to deflate automatically once the pump stops. MAN0014-DFU • Rev. A • 5/13 Wallach Surgical Devices...
- Page 21 Place the probe over the artery at an angle of approximately 45 degrees, pointing the probe tip in the direction toward the calf and knee. Slide the probe slowly across the artery until the best signal is obtained. MAN0014-DFU • Rev. A • 5/13 Wallach Surgical Devices...
- Page 22 The system can be configured for exam protocols that use either one or two (DP and PT) ankle pressure measurements. See Section 5 for information on how to set the Ankle Protocol. MAN0014-DFU • Rev. A • 5/13 Wallach Surgical Devices...
- Page 23 The displayed ABI will be either the higher or the lower value, depending on the user setting. VISTA TIP: SITE • When conducting the ABI exam on an amputee, use the key to select the appropriate pressure/waveform locations. MAN0014-DFU • Rev. A • 5/13 Wallach Surgical Devices...
- Page 24 Moderate Disease 0.00 to 0.40 Severe Disease See Section 11 for File Management information including saving, printing, recalling patient data, and for information on how to reset for new patient data. MAN0014-DFU • Rev. A • 5/13 Wallach Surgical Devices...
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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. MAN0014-DFU • Rev. A • 5/13 Wallach Surgical Devices... - Page 26 The Vista AVS 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 MAN0014-DFU • Rev. A • 5/13 Wallach Surgical Devices...
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Page 27: Section 8: 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. MAN0014-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. MAN0014-DFU • Rev. A • 5/13 Wallach Surgical Devices...
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Page 29: Section 9: Segmental Studies
ENTER/MENU OPTIONS menu again and then press the number key for SYSTEM SETTING. Press the number key to choose a modality for obtaining pressures (either PPG or DOPPLER). MAN0014-DFU • Rev. A • 5/13 Wallach Surgical Devices... - Page 30 High Thigh Exception: The pressure should be at least 20 mmHg above the brachial pressure. • Abnormal High Thigh Exception: A pressure drop of 30 mmHg from the high thigh to above knee is • suggestive of disease. MAN0014-DFU • Rev. A • 5/13 Wallach Surgical Devices...
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Page 31: Section 10: Individual Site Mode
7 for a more detailed explanation of obtaining pressures and waveforms using a Doppler, PVR or PPG. To exit the INDIVIDUAL SITE MODE, use the keys to select EXIT and press DOWN key. ENTER/MENU MAN0014-DFU • Rev. A • 5/13 Wallach Surgical Devices... -
Page 32: Section 11: 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. MAN0014-DFU • Rev. A • 5/13 Wallach Surgical Devices... - Page 33 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. MAN0014-DFU • Rev. A • 5/13 Wallach Surgical Devices...
- Page 34 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. MAN0014-DFU • Rev. A • 5/13 Wallach Surgical Devices...
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Page 35: Section 12: 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. MAN0014-DFU • Rev. A • 5/13 Wallach Surgical Devices... - Page 36 (shown below) is usually diminished, but this condition is not sufficient for diagnosis because amplitude is influenced by additional factors such as blood pressure, arrhythmia, vasomotor tone, and limb position. MAN0014-DFU • Rev. A • 5/13 Wallach Surgical Devices...
- Page 37 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. MAN0014-DFU • Rev. A • 5/13...
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Page 38: Section 13: 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 39 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. MAN0014-DFU • Rev. A • 5/13 Wallach Surgical Devices...
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Page 40: Section 14: 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 AVS from the wall during an exam. This may result in system reset. MAN0014-DFU • Rev. A • 5/13 Wallach Surgical Devices... - Page 41 • 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.
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Page 42: Section 15: Specifications
>4 KHz Waveform Display: Digital Mean Frequency Estimator Separate Forward and Reverse Flow Waveforms Available Probe Frequencies: 8.43 MHz, 5.5 MHz Displayed Waveform Amplitude Accuracy: ±10% Speaker Output > 0.25 W MAN0014-DFU • Rev. A • 5/13 Wallach Surgical Devices... - Page 43 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. MAN0014-DFU • Rev. A • 5/13 Wallach Surgical Devices...
- Page 44 Stand height: 47″ Temp. 10 to 30 C, Humidity 30 to 75% non-condensing Operating Conditions: Transport & Storage Conditions: Temp. –20 to 50 C, Humidity 5 to 90% non-condensing MAN0014-DFU • Rev. A • 5/13 Wallach Surgical Devices...
- Page 45 Vista AVS 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 MAN0014-DFU • Rev. A • 5/13 Wallach Surgical Devices...
- Page 46 < 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. MAN0014-DFU • Rev. A • 5/13 Wallach Surgical Devices...
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Page 47: Section 16: Accessories
SECTION 16: 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. Cuffs and Tubing: Cuff, 10 cm CUF0002 Cuff, 12 cm CUF0003 Cuff, 17 cm CUF0008 Cuff, 1.9 cm... -
Page 48: Section 17: Troubleshooting Guide
SECTION 17: 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 AVS contains no user serviceable components. -
Page 49: Section 18: 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 MAN0014-DFU • Rev. A • 5/13 Wallach Surgical Devices... -
Page 50: Section 19: Avs Report
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. MAN0014-DFU • Rev. A • 5/13 Wallach Surgical Devices... - Page 51 Insert the AVS Report installing disk into the CD ROM Drive. Installation will start automatically and the following screen will appear: NOTE: The standard installation does not include DICOM formatted file option. To install the DICOM feature, contact Wallach Surgical Devices. 1. When you begin to install the AVS Report software, this screen will appear.
- Page 52 USB Port on the PC. Once the cable is connected to both devices, turn on the Vista AVS . When the computer successfully recognizes the device, the following message will appear: MAN0014-DFU • Rev. A • 5/13 Wallach Surgical Devices...
- Page 53 On the Vista AVS 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. MAN0014-DFU • Rev. A • 5/13 Wallach Surgical Devices...
- Page 54 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 55 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. MAN0014-DFU • Rev. A • 5/13 Wallach Surgical Devices...
- Page 56 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 MAN0014-DFU • Rev. A • 5/13 Wallach Surgical Devices...
- Page 57 “Other” section if the desired code is not available. Only one selection can be valid on any given report. MAN0014-DFU • Rev. A • 5/13 Wallach Surgical Devices...
- Page 58 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. MAN0014-DFU • Rev. A • 5/13 Wallach Surgical Devices...
- Page 59 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. MAN0014-DFU • Rev. A • 5/13 Wallach Surgical Devices...
- Page 60 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. MAN0014-DFU • Rev. A • 5/13 Wallach Surgical Devices...
- Page 61 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. MAN0014-DFU • Rev. A • 5/13 Wallach Surgical Devices...
- Page 62 Completed Sample ABI Report in PDF File Format MAN0014-DFU • Rev. A • 5/13 Wallach Surgical Devices...
- Page 63 Completed Sample Seated ABI Report in PDF File Format MAN0014-DFU • Rev. A • 5/13 Wallach Surgical Devices...
- Page 64 Completed Sample Segmental Study Report in PDF File Format MAN0014-DFU • Rev. A • 5/13 Wallach Surgical Devices...
- Page 65 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 MAN0014-DFU • Rev. A • 5/13 Wallach Surgical Devices...
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Page 66: Section 20: 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 67: Section 21: 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 MAN0014-DFU • Rev. A • 5/13 Wallach Surgical Devices... - Page 68 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 MAN0014-DFU • Rev. A • 5/13 Wallach Surgical Devices...
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Good Afternoon We are an internal medicine practice with your ABI machine. We have at some point, lost the disc to download the software to the computer. Is there a way to get a new disc?