User Manual for Vantage ABI TM REF MAN0030‐DFU • Rev.
Vantage ABI User Manual Table of Contents Page Section 1: Introduction .................................................................................................................. 1 Section 2: Safety Information ........................................................................................................ 2 Section 3: Description of Product and Controls............................................................................. 3 Section 4: Preparing the System for Use ....................
Section 1: Introduction TM Thank you for choosing the Vantage ABI from Wallach Surgical Devices. We believe you have purchased one of the finest arterial examination systems available. Your total satisfaction is our highest priority. We strive to continually improve our products and services. Please contact us with any suggestions. We look forward to enjoying a long‐term relationship with you! Wallach Surgical Devices 95 Corporate Drive Trumbull, CT 06611 USA Year of manufacture located on the device.
Section 2: Safety Information Intended Use: The Vantage ABI is a non‐invasive device used to gauge the lower extremity arterial system using pneumatic volume plethysmography recording (PVR) and oscillometric systolic blood pressure to assist in the diagnosis of vascular disease. Contraindications: WARNINGS • This device is for use only on or near intact skin. • This device is not intended for pediatric or fetal use. • This device is not intended for use with HF surgical equipment.
Section 3: Description of Product and Controls The Vantage ABI is an innovative system with a cuff‐based technology for performing the ankle‐brachial index (ABI) exam used to assist in the diagnosis of peripheral arterial disease (P.A.D.). The system provides accurate measurement of the ABI across the full range of P.A.D., including patients with severe P.A.D., without the use of a Doppler or a photoplethysmography probe. The Vantage ABI is well suited for the ABI exam.
DISPLAY SCREEN/ABI MAIN SCREEN Section 4: Preparing the System for Use 1. Review the unit and locate each of the controls and connectors (see Section 3 and below). 2. Plug the external power supply into the +7VDC (power) connector. 3. For first time use, allow the unit to charge for at least one hour before operating the Vantage ABI from its battery. Plug the power cord into the external power supply and then into a properly grounded wall outlet. 4.
Section 5: Menu Configuration and Set Up Loading Paper The Vantage ABI is shipped with paper pre‐loaded. To load a new roll of paper, press the printer release button. Remove any remaining paper from the old roll and drop in the new roll as shown below. Close the printer door and push firmly enough to latch the door into position. Press the FEED button to ensure proper paper alignment. See image below for proper loading. WARNING • Printer components become hot during printing.
By selecting SYSTEM SETTINGS, the SYSTEM SETTINGS menu appears that allows for customizing the system. Touch BACK to return to the ABI main screen. Under SYSTEM SETTINGS... • Touch SET CLOCK to change the clock/calendar using the numeric keypad. Touch CLEAR to make a correction, DONE when finished or CANCEL to exit without changes. • Touch SET CONTRAST to adjust the display contrast. Continue touching/tapping until the contrast is optimum.
By selecting EXAM MANAGEMENT under MENU OPTIONS, the EXAM MANAGEMENT menu will appear allowing for saving, viewing, deleting and exporting patient exams. There are 20 exam storage locations on the system. After all 20 storage locations are filled, delete or export the saved exams in order to begin storing more. • • • • • • • • • Touch MENU and then touch EXAM MANAGEMENT under MENU OPTIONS to view a listing of saved exams – if no exams have been saved, the screen will be empty.
To begin a new exam, touch NEW EXAM from MENU OPTIONS and the alpha‐numeric keypad will appear for entering a filename or patient identification. • • • Touch NEW EXAM when you want to enter a filename for an exam prior to starting. Use the alpha‐numeric keypad on the screen to enter a filename. Touch CLEAR or BACK to make a correction or DONE when finished. After touching DONE, the ABI main screen will appear to begin the exam.
Meaning of Symbols on Display Screen/ABI Main Screen SITE DISABLED SITE COMPLETE INCREASE THE PRESSURE LIMIT (180 IS THE DEFAULT PRESSURE & 280 IS THE OPTIONAL PRESSURE) DECREASE THE PRESSURE LIMIT (60 IS THE DEFAULT PRESSURE & 35 IS THE OPTIONAL PRESSURE) CUFFS INFLATING CUFFS DEFLATING SYSTEM IS CALCULATING ERRATIC WAVEFORM DETECTED – NOT ANALYZABLE ABNORMAL RESULTS DETECTED PAD cannot be excluded MAN0030‐DFU • Rev.
Section 6: Performing the ABI Examination Preparing the Patient In a warm room, have the patient take off his/her shoes and socks and rest in a supine position for approximately 5 minutes prior to taking pressures. The patient should wear thin, loose fitting clothing. Avoid rolling up sleeves or pant cuffs in such a manner that it obstructs blood flow. Bulky items such as sweaters should be removed. Wrap the cuffs snuggly around arms and ankles as shown below.
Color‐Coded Hose Connectors BLACK = Right Ankle BLUE = Left Ankle WHITE = Right Arm GREEN = Left Arm To disable any site (limb pressure or PVR waveform), select the location by touching the site on the screen. A listing of options will appear along the right column of the screen. Touch OFF to disable the site and then touch DONE to return to the ABI main screen. An X will be displayed at the site indicating that it has been disabled.
As soon as the Vantage ABI obtains and records the PVR waveforms and systolic pressures on the patient’s right‐side, the system begins the same process on the patient’s left‐side to complete the exam. When the Vantage ABI is configured and the patient is prepared, an ABI exam can be completed in just 3 minutes! NOTE: The exam can be stopped at any time by touching DONE on the screen or by turning the system off by pressing the gray, circular ON/OFF button.
Not Analyzable Message The symbol NA means the signal is not analyzable. NA may be due to heart arrhythmias, limb tremors, the patient moving or talking, loosely wrapped cuffs and heart rates above 120 or below 43. If NA is due to tremors or moderate‐to‐severe arrhythmia, repeating may not help. In many cases, the cause of an NA result may be determined by observing the PVR signal. See Section 7: Obtaining Pressures and Waveforms Manually for more information.
Assessment of the ABI The Vantage ABI automatically calculates the ankle brachial index (ABI) for both sides. The right and left ABI are both calculated using the higher of the two brachial pressures. ABI Assessment* Above 1.30 1.00 to 1.29 0.91 to 0.99 0.41 to 0.90 0.00 to 0.40 Noncompressible Artery Normal Borderline (equivocal) Moderate Disease Severe Disease * ACC/AHA Guidelines for Management of Patients With Peripheral Arterial Disease, 2005.
Section 7: Obtaining Pressures and Waveforms Manually Getting Started To manually obtain waveforms using the Vantage ABI, touch MENU on the main screen and then touch SYSTEM SETTINGS from MENU OPTIONS. Touch WAVEFORMS to set to MAN and then touch BACK to return to the ABI main menu. Now, the Vantage ABI is set so the clinician can manually obtain PVR ankle waveforms. Properly wrap the blood pressure cuffs around the patient’s arms and ankles. Refer to Section 6 for preparing the patient.
Changing the Limit If the system requires that a pressure limit be changed, an inflation increase L↑ or a deflation decrease L↓ symbol will appear as well as a pop‐up message. To change the limits touch the pressure site on the screen and then touch LIMIT on the right side of the display. To override the default setting for the current exam, touch the appropriate LIMIT OVERRIDE button. The deflation default is factory set to 60 mmHg and the override option is 35 mmHg.
SAMPLE OF THE DISPLAY SCREEN/ABI MAIN SCREEN AFTER COMPLETING EXAM To skip or disable an ankle waveform site, touch the waveform site to be skipped and then touch OFF. Touch DONE to return to the ABI main screen and an X will appear at the site, indicating it is to be skipped. To reset that site, touch the site on the ABI main screen, touch ENABLE and the touch DONE to return to the main screen. The X will disappear so an ankle waveform can be obtained.
Section 8: Exam Management NOTE: Exam reports can be configured for either numeric or alpha character filenames. New Exam Touch MENU on the main screen to open MENU OPTIONS, then touch NEW EXAM. NOTE: A pop‐up warning will appear to notify the user that any unsaved data will be lost. Use the alpha‐numeric keypad to enter the filename or patient identification. Touch SPACE to insert a space. Touch BACK to move back one character. Touch CLEAR to make a correction or DONE when finished.
Deleting a File To delete a saved exam, touch MENU to open MENU OPTIONS, then touch EXAM MANAGEMENT. Touch the up arrow to scroll up through the list. Touch the down arrow to scroll down through the list. Touch ALL to select all of the exams in the list. Touch the exam you want to delete to select it and then touch DEL to delete the exam selected. NOTE: A POP‐UP WARNING WILL APPEAR TO ASK IF YOU ARE SURE THAT YOU WANT TO PERMANENTLY DELETE THE EXAM.
Section 9: Pulse Volume Recording (PVR) Waveform Interpretation PVR waveform serves as a qualitative aid in the assessment of peripheral hemodynamics. The waveform contour is useful to confirm the results of the ABI and is a valuable diagnostic tool for patients with noncompressible vessels (ABI > 1.30). Additionally, PVR can be used to monitor limb perfusion after revascularization. Normal plethysmography waveforms resemble the arterial pressure pulse.
Distal to an arterial occlusion, the waveform becomes more rounded with a more gradual up slope, and the down slope may bow away from the baseline. Amplitude of the abnormal waveform (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. SAMPLES OF ABNORMAL PVR WAVEFORMS ABI of .
Section 10: Maintenance and Cleaning Cleaning Precautions WARNINGS • The Vantage ABI is not designed for liquid immersion. Do not soak or drop the main unit or any of its accessories in liquids. Do not use solvent cleaners. Do not use products containing bleach. Use only the recommended spray or wipe cleaners and disinfectants (see the Cleaning and Disinfection subsection below). • The Vantage ABI is not designed for sterilization processes such as autoclaving, irradiation or hydrogen gas.
CAUTION • Many products contain Ammonia, Phosphates, and/or Ethylene Glycol, which are NOT ACCEPTABLE; check product content label carefully. Vantage ABI users should wash hands and change gloves after every exam. Refer to local and hospital policies regarding cleaning and disinfection. Store the Vantage ABI in a clean area free of dust and debris. Follow the temperature and humidity storage requirements as specified in Section 12.
Section 11: Battery Recharging and Replacement The external power supply, Product Number B200, supplied by Wallach Surgical Devices, becomes the power source when the Vantage ABI is operated while the supply is connected. When the external power supply is connected while the Vantage ABI is off, the supply provides power for recharging. Plug the supply into the +7VDC (POWER) connector. The green CHARGING indicator stays on during charging. The indicator flashes during the trickle charge.
Replacing the Battery Tool required: Phillips head screwdriver To replace the battery, use a Phillips head screwdriver to remove the battery compartment screw. Press the latch on the side of the battery connector and unplug the old battery. Plug in the new battery and close the battery door. Tighten the screw firmly but do not over tighten. Charge the new battery for 2 hours prior to use. CAUTIONS • Use only replacement battery packs as specified by Wallach Surgical Devices.
MECHANICAL Main Unit Dimensions: Weight: 6.4" x 11" x 7.3" (16.25 x 27.9 x 18.5 cm) H x W x D 4.6 lbs (2.1 kg) Mounting: Portability: Self‐supported (rubber feet) or stand mounted (optional) Built‐in carry handle SAFETY Standards: IEC60601‐1, IEC60601‐1‐2 EMC Classification: Class A This equipment was tested to applicable standards for electromagnetic interference.
ENVIRONMENTAL Operating conditions: Temperature: Humidity: 10 – 30 °C 30 – 75% non‐condensing Transport & Storage Conditions: Temperature: ‐20 to 50 °C Humidity: 5 – 90% non‐condensing Section 13: Troubleshooting Guide 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 Vantage ABI contains no user serviceable components. Only qualified personnel should attempt to service the unit.
Section 14: Clinical References Clinical References: Aburahma AF, Diethrich, EB (eds): Current Noninvasive Vascular Diagnosis. Littleton MA, PSG Publishing, 1988. American Diabetes Association: Peripheral Arterial Disease in People with Diabetes (Consensus Statement). Diabetes Care 26:3333‐3341, 2003. American Heart Association: Human Blood Pressure Determination by Sphygmomanometry, 2001. Daigle RJ: Techniques in Noninvasive Vascular Diagnosis – an Encyclopedia of Vascular Testing.
Section 15: Vantage ReportTM – Report Generation Software The Vantage Report software allows the clinician to download examination results from the Vantage ABI and annotate patient data, add clinician interpretation and comments, store and print a patient examination report. WARNINGS • User supplied external hardware used to operate the Vantage Report software should conform to recognized standards for safety such as IEC601‐1, IEC60065, UL2601‐1 or UL544.
Installation instructions: Insert Vantage Report installing disk into CD ROM Drive. Installation will start automatically and the following screen will appear: 1. When you begin to install the Vantage Report software, this screen will appear. Select “Next” to continue the installation. 2. Select “Install” to load to the Vantage Report software program to your computer. 3. This screen appears as the installation is in process. 4. Select “Finish” to complete the installation process. MAN0030‐DFU • Rev.
Starting Vantage Report: If the installation was completed properly, an application icon is added to your computer desktop. Double click on the icon to start the software. Report data is segmented into 2 sections of the software and separated by tabs at the top of the application. Select the appropriate tab to access or enter information. Patient Info – User editable information regarding the patient, general comments and the examiner identification.
Current Symptoms – Check appropriate boxes to enter the patient’s P.A.D. symptoms and the location of the symptoms. The “Other” section can be used for extra details such as when or how often symptoms occur. Examiner Comments – General comments and interpretation sections are provided for extended comments from the interpreting clinician or from the examiner.
Managing a Report: File Menu: Open: Allows the user to open a previously saved report. Save/Save As: Allows the user to select the report name and location for later recovery and backup. Close: Allows the user to close out of the currently opened file. Import: Allows the user to import a file from USB memory stick. Export: Allows the user to generate an Adobe® PDF file or Comma Delimited file for export. See page 36 for further explanation on exporting files.
Preferences Menu: . This screen allows the user to enter facility information that will be included in the report, such as facility name and address. This information will be stored in the application and used on each subsequent report that is generated until the information is changed. The File Paths menu allows the user to select a default directory for each file format to save exams.
This screen allows a user to customize the severity table shown in the report. The default is from the ACC/AHA guidelines. To customize, select “Custom”. To edit the text line, double‐click the text line. To delete the text line, right‐click the text line. To add a new line, click on “New Line” and left‐click and drag to a new location. Press “OK” when editing a line of text. This screen will appear next. Click “OK” when complete. MAN0030‐DFU • Rev.
Importing a Report/File To import a file from a USB, insert a USB memory stick and select “Import” from the file menu on the main screen. Select the USB drive at the top of the window. Select ABI file and click “Open” to open the file. If more than one exam is contained in the .abi file, this window will appear. Select the exam or click on “Select All” to open all of the exams. Exporting a Report/File: There are three file export types that are supported: two for Adobe PDF and Comma Delimited files (.
- Enter a file name and save it to convert the current file to this format and the Adobe application (if it is currently loaded on the PC) will automatically start. - If the application is not loaded, a free reader version can be downloaded from the website: www.adobe.com - Once the file has been converted and opened into the Adobe application, all features and functions of that application are supported. The file can be saved, printed, e‐mailed, etc.
Completed Sample ABI Report in PDF File Format MAN0030‐DFU • Rev.
Example of data from a comma‐delimited file: MAN0030‐DFU • Rev.
Section 16: Warranty The Vantage ABI is warranted against defects in material and workmanship for 12 months from the original sale of the device. Product life is specified to be 5 years from manufacture, though the device may be repairable beyond this timeframe. This includes all parts and labor required to repair or replace the unit to original specifications and shipping costs associated with sending the product back to the customer.
Section 17: Explanation of Symbols REF Reorder Number SN Serial Number Keep Dry Type B Applied Part Latex Free Class II Equipment ATTENTION: See instructions for use. Manufacturer Date of Manufacture Symbol indicates that the device should be sent to the special agencies according to local regulations for separate collection after its useful life. Vantage ABITM, Vantage ReportTM, Summit DopplerTM and Wallach® are trademarks of CooperSurgical, Inc.
95 Corporate Drive Trumbull, CT 06611 USA Phone: (203) 799-2000 Fax: (203) 799-2002 customerservice@wallachsurgical.com www.wallachsurgical.com Made in the USA MAN0030‐DFU • Rev.
