User Manual for Vantage ABI
Contents
1. RIGHT Brachial 120 mmHg Ankle 141 mmHg 1 12 Index 1 1 U E EE DTA K L AOR ec Bind L E L L 1 4 Rd Kei Interpretation Normal ABI Results MANO030 DFU e Rev Ae 2 13 38 Patient Sex M Patient ID 1234567890 Current Symptoms XJ Intermittent Claudication Numbness Tingling in Feet C Buttocks L Ulcerations Vascular Clinic 123 Main St Ft Collins CO 80123 Age 70 Exam Date 11 09 10 14 52 29 ABI Severity of Disease Location gt 1 3 Non compressible 1 0 1 29 Normal 0 91 0 99 Borderline 0 41 0 90 Moderate to Mild 0 00 0 40 Severe LI Thigh C Calf XX Feet Referring Physician Dr Fred Jones LEFT Brachial 125 mmHg Ankle 139 mmHg 1 11 Index iD 15 20 25 30 35 40 Seconds Wallach Surgical Devices TitleLine1 TitleLine2 PatientName PatientID Comments Location Right Location Left BrachialRight BrachialLeft Location2Right Location2Left Location2PressureRight Location2PressureLeft IndexRight IndexLeft WaveformScaleRight WaveformScaleLeft WaveformTimeStampRight WaveformTimeStampLeft PatientAge Date FacilityName FacilityAddr Interpretation InterpretingPhysician ReferringPhysician PatientDOB PatientSex MANO030 DFU e Rev Ae 2 13 Example of data from a comma delimited file Lower Extremity Physiologic Study Single Level ABI Exam Mr John Smith 1234567890 Exam performed by Sheila Brachial Brachial2. are trademarks of CooperSurgical Inc Clorox is a registered trademark of The Clorox Company Microsoft Word Excel and Windows are registered trademarks of the Microsoft Corporation of the United States and other countries Adobe is a registered trademark of Adobe Systems Incorporated Glass Plus is a registered trademark of Reckitt Benckiser LLC Klear Screen is a trademark of Meridrew Enterprises 2013 Wallach Surgical Devices MANO0030 DFU e Rev Ae 2 13 41 Wallach Surgical Devices WAILACH SURGICAL DEVICES 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 MANO030 DFU e Rev Ae 2 13 Wallach Surgical Devices
3. 90 Clinical Specificity gt 92 See page 16 for information on selecting alternate inflate deflate limits Specified time is typical for measuring four limb pressures between 50 and 170 mmHg Doppler ABI and PPG TBI were the references for determining Sensitivity and Specificity MANO030 DFU e Rev Ae 2 13 25 Wallach Surgical Devices MECHANICAL Main Unit Dimensions 6 4 x 11 x 7 3 16 25 x 27 9 x 18 5 cm HxWxD Weight 4 6 Ibs 2 1 kg Mounting Self supported rubber feet or stand mounted optional Portability 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 If interference occurs attempt to eliminate the source of the interference or increase the distance between the Vantage ABI and the source of the interference WARNING e The Vantage ABI and its External Power Supply are a medical system Connect the Vantage ABI only to equipment that meets the appropriate standards Classification Internally Powered when battery powered o Class II when powered by external supply Degree of Protection Against Electric Shock b Type B Applied Part POWER Battery 7 2V NiMH custom pack with thermal and over current protection Replacement Part B200 Replacement Interval 1 year External Power Adaptor Medical Grade Power Supply Input 100 240 VAC 50 60 Hz 1 2 Amp Output 7VDC 5A
4. VANOOOS7 ABI 2KB ABI File 12 27 C4 ANOOO8S ABI 2KB ABI File 12 27 Select All Select None PEE vano0089 ABI 2KB ARI ple 12 27 ANOO091 ABI 2KB ABI File 12 27 e VANOO092 ABI 2KB ABI File 12 28 95 vano0093 AB1 2KB ABI Fie 222 If more than one exam is contained in the abi My Computer i x i E file this window will appear Select the exam Fiename E or click on Select All to open all of the exams My Network Files of type Vantage Data Files abi lt Cancel Places sr PT e Exporting a Report File There are three file export types that are supported two for Adobe PDF and Comma Delimited files csv PLEASE NOTE The saved files will default directly into the folder initially created in the File Path menu to store the Vantage Report software File Preferences Windows About Open Save ort Reportsample Report Supine yan Close SAVE 45 Import Sura avglormms Export and Launch Acrobat Export Report File Only Export Adobe Acrobat t pdf Print Comma Delimited csv Print Preview Printer Select Exit t Name PE Date of Bith Adobe PDF 2 Options 1 Select File gt Export gt Adobe Acrobat pdf gt Export and Launch Acrobat to immediately view the PDF file on your computer screen 2 Select File gt Export gt Adobe Acrobat pdf gt Export Report File Only to save store the file to view at a later time MANO030 DF
5. 0 99 Borderline Bs delete the text line right click the text line To add a 0 41 0 90 Moderate to Mild l P l 00 040 Severe new line click on New Line and left click and drag to anew location Press OK when editing a line of To edit text line Double click text line to edit the text text To delete text line Right click text line and select Delete To add a new line Click on New Line box below Lett click and drag to new location Edit Text This screen will appear next Click OK when complete MANO030 DFU e Rev Ae 2 13 35 Wallach Surgical Devices 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 Select Vantage Data File 03 07 10 15 31 15 09 07 10 15 35 59 09 07 10 15 41 53 09 07 10 15 46 57 09 07 10 15 48 49 OK Cancel 09 07 10 15 49 04 09 07 10 15 49 28 09 07 10 15 49 44 09 07 1015 49 59 Look in e lse Ee HUG 2319 le Name Size Type Date VANOOOBO ABI 2KB ABI File 12 27 uae eal vaNooos1 ABI 2KB ABI File 12 27 pi VANOOO82 ABI 2KB ABI File 12 27 a VANOOO83 ABI 2KB ABI File 12 27 er BL 2KB ARI ple 12 27 7 l B VANOOO8S ABI 2KB ABI File 12 27 Indicates that the exam was previously exported from the Vantage ABI E
6. 120 125 Ankle Ankle 141 139 112 111 PVR X1 PVR X1 11 9 2010 14 51 11 9 2010 14 51 70 11 9 2010 14 52 Vascular Clinic 123 Main St Ft Collins CO 80123 Normal ABI Results Dr Steve E Meyers Sr Dr Fred Jones 3 10 1940 M 39 Wallach Surgical Devices 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 The customer is responsible for providing adequate packaging materials and shipping costs to Wallach Surgical Devices Products shall be repaired or replaced in a reasonable amount of time Wallach Surgical Devices liability for any claim is limited to materials and labor associated with repair or replacement In no event shall Wallach Surgical Devices be liable for incidental or consequential losses or damages in connection with the purchase of this product 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 of shipments to Wallach
7. ABI will inflate the cuff at the site selected to 65 mmHg The system will display the PVR waveform on the screen Touch the SCALE option to change the size of the waveform to be as large as possible without clipping at the top After viewing for 4 to 5 seconds touch SAVE to record the PVR ankle waveform A checkmark will appear in the main screen as shown on the next page at the site to indicate that the waveform was obtained MAN0030 DFU Rev Ae 2 13 16 Wallach Surgical Devices SAMPLE OF THE DISPLAY SCREEN ABI MAIN SCREEN AFTER COMPLETING EXAM ania LOS PUR P nns L Z U Kals 69 85 2616 09 31 39 MENU 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 To view an ankle waveform touch the checkmark next to the PVR site and the ankle waveform obtained will appear Touch DONE to return to the previous screen MANO030 DFU e Rev Ae 2 13 17 Wallach Surgical Devices 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
8. 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 To enable the site touch ENABLE and then touch DONE to return to the ABI main screen The X is no longer displayed at that site indicating that a pressure or waveform can be obtained Obtaining the Pressures and Ankle Waveforms CAUTION e Hoses must be connected to the proper limb as indicated previously Correct connection is essential for accurate ABI determination After the cuffs have been wrapped you are ready to start the exam On the ABI main screen touch START and the Vantage ABI will begin to inflate the ankle cuff on the patient s right side to obtain the PVR waveform Again it is important that the patient remain still during the exam so the system can record good PVR waveforms and accurate systolic pressures Wait a few seconds and the cuff will stop inflating once the pressure limits are met and a checkmark will appear at the PVR site on the screen NOTE If obtaining PVR waveforms in manual mode by selecting MAN for WAVEFORMSS under the SYSTEM SETTINGS menu the clinician manually controls pumping the cuffs changing the scale saving the waveform and selecting DONE to mov
9. appear Select Next to continue the installation WARNING This program is protected by copyright law and international treaties cea e Gre ie YantageReport InstallShield Wizard Ready to Install the Program The wizard is ready to begin installation If you want to review or change any of your installation settings click Back Click Cancel to pees 2 Select Install to load to the Vantage Report software program to your computer Destination Folder C Program Files Summit Doppler antageReport User Information Name Neil D Company Summit Doppler Systems InstallShield Cae Ce Cae ie YantageReport InstallShield Wizard Installing antageReport The program features you selected are being installed m re 3 This screen appears as the installation is in process aj ee ee Wizard installs VantageReport This may Status Writing system registry values InstallShield a gt const ie YantageReport InstallShield Wizard InstallShield Wizard Completed The InstallShield Wizard has successfully installed 4 Select Finish to complete the installation process O a CO l a MAN0030 DFU Rev Ae 2 13 30 Wallach Surgical Devices 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 sof
10. data USB disk not supported message Data previously written to the USB drive interferes with export process From a PC delete files from the USB drive and start Vantage export process again MANO030 DFU e Rev Ae 2 13 2 Wallach Surgical Devices 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 Sohygmomanometry 2001 Daigle RJ Techniques in Noninvasive Vascular Diagnosis an Encyclopedia of Vascular Testing Littleton CO Summer Publishing 2002 137 153 Gerlock AJ Giyanani VL Krebs C Applications of Noninvasive Vascular Techniques Philadelphia W B Saunders 1988 299 332 413 434 Hirsch AT Haskal ZJ Hertzer NR Bakal CW Creager MA Halperin JL Hiratzka LF Murphy WRC Olin JW Puschett JB Rosenfield KA Sacks D Stanley JC Taylor LM Jr White CJ White J White RA ACC AHA Guidelines for the Management of Patients with Peripheral Arterial Disease Lower Extremity Renal Mesenteric and Abdominal Aortic A Collaborative Report from the American Association for Vascular Surgery Society for Vascular Surgery Society for Cardiovascular Angiography and Interventions Society of Interventional Radiology
11. date of previous CV event Other Previous CY Event Previous Vascular Surgery MANO030 DFU e Rev Ae 2 13 31 Wallach Surgical Devices Current Symptoms Current Symptoms WER l l T popstar Check appropriate boxes to enter the patient s RIS r Buttocks P A D symptoms and the location of the F Ulcerations l Thigh S T Rest Pain T Calf symptoms The Other section can be used for ara z angrene Feet extra details such as when or how often Bee symptoms occur Comments Examiner Comments Interpretation General comments and interpretation sections are provided for extended comments from the interpreting clinician or from the examiner Pressures Waveforms and ABI Values Pressures Waveforms Tab The ankle and brachial pressures download from the Vantage ABI are included in the Pressure ABI Tab A reference table is also displayed for ABI clinically accepted values as an aid for the clinician in determining a diagnosis ABI Exam C WantageReport Reports Sample Report Supine van Patient Info Pressure Waveforms j Patient Name Mr John Smith Lower Extremity Physiologic Study Single Level ABI Exam l Arm and Ankle Pressures Right Left gt 14 se ae Brachial 0 Brachial Reference ABI Table 91 039 Borderine 120 ae 125 1 U loderate to Mil mmHg L C mmHg Ankle l Ankle 141 139 mmHg k A mmHg 1 12 l 1 11 Index fo Index ABI Value PVR Waveforms 1109 10 14 51 55 11 09 10 14 51
12. 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 NOTE To complete the exam it is recommended that the clinician check the cuffs ensure the patient is still and retake the pressure at the indicated site one more time but not repeat multiple times Evaluate the waveforms and take the ABI using an alternate means if required Exam site Not Analyzable due to low signal auality or low heart rate Press the HELP button on the risht side of disrlay or refer to user manual Abnormal Results Message The symbol AR indicates that the device has captured an abnormal blood pressure waveform and PAD cannot be excluded NOTE To complete the exam it is not recommended that the pressure site be repeated in this case Evaluate the waveforms and take the ABI using an alternate means if required Abnormal Results were detected PAD can not be excluded Press the HELP button on the risaht side of display or refer to user manual MANO030 DFU e Rev Ae 2 13 13 Wallach Surgical Devices 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
13. 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 The exam screen will appear to begin the new exam Exam Restore Backup To restore an exam that you were performing prior to powerdown touch MENU on the main screen to open MENU OPTIONS then touch RESTORE BACKUP A pop up warning will appear asking you to select RECALL and the exam will appear on the screen where you left off To exit the option select CANCEL Saving a File Touch MENU on the main screen to open MENU OPTIONS then touch SAVE EXAM 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 DONE when finished or CANCEL to exit without changes The ABI main screen will then appear to begin the exam Viewing a File To recall and view a previously saved exam touch MENU to open MENU OPTIONS then touch EXAM MANAGEMENT All saved exams will be listed under EXAM MANAGEMENT Touch the up arrow to scroll up through the list Touch the down arrow to scroll down through the list Touch BACK to return to the exam screen Touch the exam that you would like to select and then touch VIEW to view the exam selected Viewed exams have both export and delete options on t
14. to that exam indicating that it has been previously exported to a USB NOTE BE SURE THE USB MEMORY STICK IS PLUGGED INTO THE SYSTEM PRIOR TO DOWNLOADING 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 BACK to return to the ABI main screen Exporting a File from USB Stick to a Personal Computer PC After exporting the data to the USB Memory Stick remove it from the Vantage ABI and insert it into a PC Open the Vantage Report software to download files for viewing on a PC MANO0030 DFU Rev Ae 2 13 19 Wallach Surgical Devices 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 gt 1 30 Additionally PVR can be used to monitor limb perfusion after revascularization Normal plethysmography waveforms resemble the arterial pressure pulse The normal PVR waveform shown below has a sharp systolic upstroke and a somewhat narrow peak After peaking the waveform drops quickly during diastole with its slope bowing in toward the baseline Normal waveforms usually have a dicrotic notch between the peak and baseline However the dicrotic notch may become less noticeable with vasodilation or may
15. 0 days without use remove the battery pack prior to storage Replace the battery pack annually or when its capacity is noticeably diminished A qualified technician must verify the accuracy of the pressure readout annually Return the Vantage ABI to Wallach Surgical Devices for calibration if needed See Section 12 for applicable pressure specifications Periodically not less than annually inspect the main unit and accessories for signs of cracks or breakage Inspect cables tubing and connectors for signs of wear or failure Inspect labels for damage including hose identification labels The user should discontinue use of the main unit or accessories if any loss of housing integrity is detected Check the tightness of the bolt that attaches the mounting bracket to the optional roll stand s pole at least annually 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 MANO0030 DFU Rev Ae 2 13 23 Wallach Surgical Devices 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 con
16. 34 MANO030 DFU e Rev Ae 2 13 32 Wallach Surgical Devices Managing a Report File Menu Preferences Windows About Open Open Save artiReportsam Allows the user to open a previously Close saved report Save as 3 Import urew avetormns Export E Print Save Save As Allows the user to select the report name and location for later recovery and backup Print Preview Printer Select Exit 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 Print Allows the user to print the report on the selected printer Print Preview 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 MAN0030 DFU Rev Ae 2 13 33 Wallach Surgical Devices Preferences Menu Preferences Facility Info File Paths ABI Severity Chart ini This screen allows the user to enter facility oe information that will be included in the report such Feeble Eo s as facility name and address This information will be stored in the application and used on each subsequent report that is generated until the informat
17. CANCEL to exit without changes ENTER CLOCK CAHCEU 181088925 e Touch SET CONTRAST to adjust the display contrast Continue touching tapping until the contrast is optimum e Touch AUTO POWERDOWN to ON which enables the system to turn itself off after 20 minutes of inactivity to save battery power when not in use or to OFF which disables the automatic power down The system default is set to ON e Touch AUTO INFLATION to change the option from a number 1 to a number 2 When number 1 is selected one limb pressure will be acquired at a time When number 2 is selected the arm and the ankle cuffs on one side of the patient will be inflated simultaneously e Touch WAVEFORMS to ON for automatic PVR waveform acquisition MAN for manual control of PVR waveforms or OFF to disable the waveform option The system default is set to ON MANO030 DFU e Rev Ae 2 13 6 Wallach Surgical Devices 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 onthe 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 Touch the box of the exam that you would like to select Touch VIEW to view the exam selected T
18. ONNECTORS PORTS COLOR CODED SummitDpppler BATTERY CHARGE CONNECTOR PORT AA MAN0030 DFU Rev A s 2 13 4 Wallach Surgical Devices 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 e Printer components become hot during printing Do not touch the metal pieces inside the paper holder immediately after printing After loading paper press the ON OFF button to begin using the instrument Navigating the System MENU OPTIONS From the ABI main screen touch MENU to make selections found in MENU OPTIONS a osYSltEM SETTINGS A FILE MANAGEMENT 9 SAVE EXAM m HEW EXAM RESTORE BACKUP MANO030 DFU e Rev Ae 2 13 5 Wallach Surgical Devices By selecting SYSTEM SETTINGS the SYSTEM SETTINGS menu appears that allows for customizing the system Touch BACK to return to the ABI main screen SYSTEM SETTINGS SET CLOCK SET CONTRAST AUTO POWERDOWN AUTO INFLATION WAVEFORMS Under SYSTEM SETTINGS e Touch SET CLOCK to change the clock calendar using the numeric keypad Touch CLEAR to make a correction DONE when finished or
19. P A D The ABI compares the systolic blood pressure at the ankles with the systolic blood pressure at the brachial arteries The system will estimate the systolic blood pressure for each limb using volume plethysmography A significantly reduced ankle pressure results in a low lt 0 9 ABI value indicating P A D ABI measurements are discussed in Sections 6 and 7 The system has a convenient user friendly touch screen and four cuffs for obtaining the pressures and ankle waveforms After wrapping the cuffs and allowing the patient to rest the entire ABI exam takes just 3 minutes using the new Vantage ABI A blood pressure cuff is applied to the limb and inflated to 65 mmHg to detect the minute fluctuations in limb volume that occur with each heart beat The PVR waveform s contour is a qualitative indicator of presence or absence of peripheral arterial disease Further waveform analysis is discussed in Section 9 The Vantage ABI includes everything that is needed to conduct fast and accurate ABI examinations including a graphic display with convenient touch screen to navigate the system a built in printer with adhesive backed label paper stand with storage basket a USB memory stick for data transfer and storage and four blood pressure cuffs The device operates from either its internal battery pack or from an external medical grade power supply at 100 240 VAC Controls and Indicators Main Unit PRINTER PAPER RELEASE ON OFF Turns th
20. Rev Ae 2 13 15 Wallach Surgical Devices Changing the Limit If the system requires that a pressure limit be changed an inflation increase Lh or a deflation decrease LW 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 The inflation increase default can be user adjusted by touching the SET INFLATION DEFAULT to 160 180 200 220 or 240 mmHg The factory set inflation override option is 280 mmHg When the selection is complete touch BACK to return to the previous screen and PUMP to inflate the cuff and restart the pressure NOTE The override options 280 mmHg for inflation and 35 mmHg for deflation are only valid for the current exam and will remain set until a new exam is started or the system is powered off Once a new exam is started the default pressure limits resume for normal operation the Set Inflate Default for inflation and 60 mmHg for deflation PARAMETERS a LIMIT OVERRIDE L d DEFAULT a LIMIT OVERRIDE 1 DEFAULT m SEE INFLATE DEFAULT Obtaining an Ankle Waveform Manuall Begin by touching an ankle waveform site either the right or the left on the ABI main screen and a list of options will appear Touch PUMP and the Vantage
21. Society for Vascular Medicine and Biology and the American College of Cardiology American Heart Association Task Force on Practice Guidelines 2005 Olin JW Clinical Evaluation and Office Based Detection of Peripheral Arterial Disease Contained in Hirsch AT Ed Primary Care Series Peripheral Arterial Disease and Intermittant Claudication Hillsborough NJ Excerpta Medica Inc A Reed Elsevier Co Bok Y Lee The Correlation of Ankle Oscillometric Blood Pressure and Segmental Pulse Volumes to Doppler Systolic Pressure in Arterial Occlusive Disease JVS 1 96 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 MANO0030 DFU Rev Ae 2 13 28 Wallach Surgical Devices Section 15 Vantage Report 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 e 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 e The Vantage ABI shall not be connected to the user supplied external hardware during an examination e The Vantage ABI and Vantage Report software shall be
22. SummitD ppler a WALLACH gal aa brand User Manual for Vantage ABI VantageABI Oe E LOW RAT CHARGE ove el u b S 4D Right Arm kn n ummitbeppler m B va a EE x REF VANABI VANMAX WALACH SURGICAL DEVICES MANO030 DFU e Rev Ae 2 13 Wallach Surgical Devices Vantage ABI User Manual Table of Contents Page SCCCON Le Tal gaes lere ON TT 1 Section 2 Setna Onen E N N 2 Section 3 Description of Product and Controls sese sees sese 3 Section A Preparing the System for US Eosin ienaa A NA 4 Section 5 Menu Configuration and Set Up sse sees eee eee eee eee 5 Section 6 Performing the ABI Examination sese eee eee eee eee 10 Section 7 Obtaining Pressures and Waveforms Manuallly cscccccssseccccsseceeceeseccceaeseceeeeneces 15 SECTION 8 Exam Manadgeme TTT 18 Section 9 Pulse Volume Recording PVR Waveform Interpretation sse eee eee eee eee eee eee 20 Section 10 gt Maintenance and be eT 22 Section 11 Battery Recharging and Replacement sss sees eee eee eee 24 SECON SPC CICA OMS cerca tias tact N a eet nce nana ieee ees eae saree iarasemecsea cee 25 Secom 13 gt Troubleshooting eps T 27 Section E Clinical RETEKENC S sini cssiviccsasaludconssadcvas nenacvenasidcranntonsasatenneogalwocgas bevveengancauens NENI 28 Section 15 Vantage Report Report Generation SOftWALeC ccccccccesecccseeceeeeseeeeeceteneseeenees 29 SECTION To WAL ela RTT 40 S ction 17 E
23. Surgical Devices improper maintenance or cleaning as described in the user manual misuse abuse alteration of the equipment from its original specifications or dismantling the unit other than by Wallach Surgical Devices approved service technicians If you need to return the Vantage ABI or one of its components or accessories for repair 1 Call Wallach Surgical Devices to obtain a Return Authorization RA and any final instructions prior to shipping 2 Clean the product prior to shipping 3 Ensure the product is well packaged and suitable for shipment Note The customer is responsible for any damage incurred during return shipment associated with improper packaging Send the product to Repair Department Wallach Surgical Devices 95 Corporate Drive Trumbull CT 06611 USA For customer service technical service cleaning maintenance or shipping questions please call 203 799 2000 or 1 800 243 2463 MANO0030 DFU Rev Ae 2 13 40 Wallach Surgical Devices Section 17 Explanation of Symbols 44 L q 6 d REF Reorder Number Rn Keep Dry Serial Number AN Type B Applied Part Latex Free Class Il Equipment See instructions for use Manufacturer A ATTENTION Date of Manufacture lt 4 Symbol indicates that the device should be sent to the special agencies according to local regulations for separate collection after its useful life Sa Vantage ABI Vantage Report Summit Doppler and Wallach
24. U e Rev Ae 2 13 36 Wallach Surgical Devices 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 Ifthe 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 Comma Delimited Files Select File gt Export gt Comma Delimited csv Enter a file name and save it to convert the current file to a delimited format that can be read using any software application for viewing text files such as Microsoft Word Microsoft Excel and Notepad These applications do not automatically open once the file has been saved This file can be used to configure data into EMR systems Special programming may be required by the system administrator MANO030 DFU e Rev Ae 2 13 37 Wallach Surgical Devices Completed Sample ABI Report in PDF File Format Lower Extremity Physiologic Study Single Level ABI Exam Patient Name Mr John Smith Patient DOB 03 10 1940 Risk Factors N Tobacco Use E Hypertension Diabetes C Hyperlipidemia I Heart Disease C Stroke TIA Rest Pain LJ Gangrene C Previous CV Event LJ Prev Vascular Surgery Interpreting Physician Dr Steve E Meyers Sr Comments Exam performed by Sheila
25. Use only the following external supplies Globtek model GTM 21097 4509 2 0 SL Power Ault model MW160A703F01 These supplies are available under part number PSA0004 Recharge Time 3 Hours A Consult Accompanying Documents MANO0030 DFU Rev Ae 2 13 26 Wallach Surgical Devices ENVIRONMENTAL Operating conditions Temperature 10 30 C Humidity 30 75 non condensing Transport amp Storage Conditions Temperature 20 to 50 C Humidity 5 90 non condensing Section 13 Troubleshooting Guide WARNINGS e Use alternate equipment in case of unit failure Call Wallach Surgical Devices Service Department if the unit or probes malfunction e Risk of Electric Shock the Vantage ABI contains no user serviceable components Only qualified personnel should attempt to service the unit CAUTION e Do not drop or mishandle the Vantage ABI and accessories Damage may occur Vantage ABI Troubleshooting Guide Check for Unit will not print Printer out of paper Paper coming off roll too loosely tighten roll Incorrect paper type Paper roll inserted improperly Unit will not pump Ensure that the hose connection is secure Vantage ABI and the cuff Verify that host PC is running Vantage Report Software and the flash drive is connected Unit shuts off POWERDOWN is set to ON or battery is low Printed waveform differs from The printed waveform always includes two additional seconds of displayed waveform waveform
26. XAM MANAGEMENT under the filename that you entered or modified prior to beginning the exam see Section 8 for information about Exam Management From the storage location the exam can be viewed deleted printed or exported to a personal computer Exam Results Checkmark A checkmark at a PVR site indicates that a waveform is complete A checkmark at an ankle pressure site indicates that data acquisition is complete but that a valid brachial pressure is needed before the pressure calculation can be completed Pressure Limit Message The symbol Lh indicates that the initial inflation was not high enough to capture the signal The symbol LW indicates that the initial deflation was not low enough to capture the signal To raise or lower the inflation deflation limit and take another pressure touch the site on the screen and then touch LIMIT Touch a selection to make the pressure limit adjustment See Section 7 Obtaining Pressures and Waveforms Manually for more information NOTE To complete the exam adjust the pressure limit and retake the pressure at the indicated site MANO0030 DFU Rev Ae 2 13 12 Wallach Surgical Devices At least one exam site reauires a change to the Pressure default limits Press the HELP button on the risht side of disrlay or refer to user manual OK Not Analyzable Message The symbol NA means the signal is not analyzable NA may be due to heart arrhythmias limb tremors the patient moving
27. antage ABI main unit is optional and sold separately U S Patents Pending MANO030 DFU e Rev Ae 2 13 l Wallach Surgical Devices 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 e This device is for use only on or near intact skin e This device is not intended for pediatric or fetal use e This device is not intended for use with HF surgical equipment General Warnings WARNINGS e If there is any indication of a malfunction press the ON OFF gray circular button to turn off the unit disconnect all hoses from the unit and remove cuffs from the patient e The Vantage ABI is for use by qualified personnel only Read the User Manual before use e Carefully route all cables and tubing to reduce the possibility of patient entanglement or strangulation e Do not allow the patient to operate any portion of the equipment e Do not place the equipment in any position that would allow it to roll fall or collide with a user or patient e Do not use equipment that is damaged or malfunctioning Seek appropriate service when needed Inspect equipment regularly for signs of damage Use alternate equipment if needed e Do not connect Luer fittings from Summit Doppler equipment into a
28. become more pronounced during vasoconstriction SAMPLES OF NORMAL PVR WAVEFORMS ABI of 1 15 I I I I I r I 4 I I I I 4 L I I I 1 I L I I I I I I I I all 1 I I I a 7 LOR 2 52 4 I L I I I et G ee I Se ee UW L bok ob Feb bk bob pete pt eee ptt te ptt tt yt ABLoF1 24 ABI of 96 MANO030 DFU e Rev Ae 2 13 20 Wallach Surgical Devices 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 I I I l I I I ABI of 82 AR Abnormal Results Again note that the waveform contour may be altered during vasodilation or vasoconstriction Improper cuff size over or under inflation low cardiac stroke volume and improper cuff application may affect the waveform contour PVR waveforms are given a Recommendation of Class Ilb in the ACC AHA P A D Guidelines Hirsch 2005 MAN0030 DFU Rev Ae 2 13 21 Wallach Surgical Devices Section 10 Maintenance and Cleaning Cleaning Precautions WARNINGS e The Vantage ABI is not designed for liquid immersion Do not soak or drop the main unit or any of its ac
29. cessories 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 e The Vantage ABI is not designed for sterilization processes such as autoclaving irradiation or hydrogen gas e The Vantage ABI is not intended for use on open skin If there is evidence of open wound contamination disinfect the main unit and accessories before using again as described below Cleaning and Disinfection of Main Unit The Vantage ABI main unit and accessories should be cleaned with a cloth dampened using warm water or with pre saturated isopropyl alcohol wipes Be sure to clean carefully along any seams but do not allow liquids to enter the unit through connectors or other openings To disinfect the unit use commercially available spray or wipe disinfectants that are registered with the 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 Vantage products Follow the instructions provided with the disinfectant and be sure to wipe the unit dry when finished Touch Screen Cleaning Information Use a soft lint free cloth The cloth may be used dry or lightly dampened with a mild cleaner or Ethanol Be sure the cloth is only lightly dampened not wet Never apply cleaner directly to touch panel s
30. 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 B K ai BATTERY REPLACEMENT K USE ONLY SUMMIT _ DOPPLER TYPE B200 gaas na VANTAGE ABI S PATENTS PENDING CAUTIONS e Use only replacement battery packs as specified by Wallach Surgical Devices The battery pack contains a temperature measurement component that is matched to the cell type and to the product requirements e Unauthorized battery substitutions will void the warranty and may cause overheating e Used NiMH batteries must be recycled or disposed of properly Do not incinerate e Use only an external power adaptor as specified by Wallach Surgical Devices Section 12 Specifications CLINICAL Cuff Pressure Range O to 280 mmHg Pressure Gage Accuracy 0 200 mmHg 3 mmHg above 200 mmHg 2 Deflation Rate 2 5 mmHg second nominal Inflation Pressure 180 mmHg Default 280 mmHg User selected Deflation Pressure 60 mmHg Default 35 mmHg User selected Pulse Rate Range 43 to 120 BPM ABI Determination Time 3 minutes Determination Pulse Volume Oscillometry Patent Pending Waveform Type Pnuematic Plethysmography Pulse Volume Recording PVR Patient Connections 4 Vascular Cuffs 6 foot hose length ea Clinical Sensitivity gt
31. e to the next site to be completed See Section 7 for manually obtaining pressures and waveforms using the Vantage ABI Once the Vantage ABI obtains the PVR ankle waveform the systolic pressures will be obtained If two cuff sites were selected to be taken simultaneously AUTO INFLATIONS is set to 2 under SYSTEM SETTINGS both the arm and ankle cuffs will inflate to the set pressure limits Wait a few seconds while the Vantage ABI obtains the systolic pressures of both the arm and ankle When complete the pressures will appear in the appropriate sites ARM for brachial pressure or ANK for ankle pressure on the screen If only one cuff site was selected AUTO INFLATIONS is set to 1 under SYSTEM SETTINGS the Vantage ABI will first inflate the arm cuff to obtain and record the pressure and then inflate the ankle cuff to obtain and record the pressure MANO0030 DFU Rev Ae 2 13 11 Wallach Surgical Devices 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 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 Now that the exam is complete it can be saved in the system s exam storage or E
32. e unit on or off with Gray button on left panel momentary actuation opens up the printer door FEED Printer feeds paper while pressed PRINT PRINT Prints out the labels for the current exam Lowsart G LOW BATT Flashing Low battery CHARGE On Charging CHARGE gt iy Flashing Charging complete trickle charging while flashing MANO030 DFU e Rev Ae 2 13 3 Wallach Surgical Devices DISPLAY SCREEN ABI MAIN SCREEN Right ABI Touch to Begin Exam eft ABI Right Arm Pressure Value eft Arm Pressure Value Right Ankle Waveform eft Ankle Waveform Right Ankle Pressure Value eft Ankle Pressure Value Time Date Stamp Touch for Help Options Touch for Menu Options 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 Plugin each of the hoses to the appropriate hose connectors which are labeled to ensure the proper hose to arterial cuff site connections 5 If your system includes the stand and storage basket refer to the Stand Assembly instructions found within the package contents for proper assembly Connectors CUFF HOSE C
33. h Surgical Devices 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 On the main screen touch the site either an arm or ankle from which to obtain a pressure and a list of options will appear along the right side of the screen as shown in the example to the left Obtaining a Pressure Manually Touch PUMP and Vantage ABI will inflate the cuff of the site you selected until the blood flow is occluded As the cuff deflates the system will record the systolic pressure value The value will appear at the site on the ABI main screen To change or re enter a pressure value touch the site to be changed and then touch ENTER Touch CLEAR to make a correction DONE when finished or CANCEL to exit without changes To skip or disable a particular site such as in the case of an amputee touch the site to be skipped and then touch OFF An X will appear at that site indicating it is to be skipped To reset that site touch ENABLE and the X will disappear so a pressure value can be obtained MANO030 DFU e
34. he screen Printing a File To print pressures and waveforms of the current exam simply press the PRINT button on the front of the main unit To print 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 or touch the exam to be printed and then touch VIEW After the saved exam appears on the screen press the PRINT button on the front of the main unit to print the pressures and waveforms Touch BACK to return to the ABI main screen MANO0030 DFU Rev Ae 2 13 18 Wallach Surgical Devices 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 Make a selection to discontinue with the deletion and the selected exam will be removed from the list Touch BACK to return to the ABI main screen Exporting a File to USB Stick To export patient exam s select an exam and then touch EXPORT to export it to a USB flash drive for viewing on a personal computer PC An E will appear next
35. ion is changed Cancel Preferences Facility Info Physician List ABI Severity Chart AVS Report Directory The File Paths menu allows the user to selecta C WantageReport Reports Select default directory for each file format to save a n exams CSV Export Directory Ic WantageReport CS Select PDF Export Directory Ic VantageReport PDF Select DICOM Export Directory Ic WantageReport DICOM Select OK Cancel Preferences Facility Info File Paths This screen allows the user to enter physician Dr Joe Smith Dr Fred Jones names to be used for referring or interpreting physician on the patient information tab Select Add to enter a new name OK Cancel Please Enter Hame T oe Enter the information in the fields and click OK retin Droo Given Steve Middle 7 Family Meyers Suffis sr UL Lancel MANO030 DFU e Rev Ae 2 13 34 Wallach Surgical Devices Preferences Facility Info File Paths This screen allows a user to customize the severity bap miea table shown in the report The default is from the 1 0 1 29 Normal S ACC AHA guidelines To customize select Custom 0 00 0 40 Severe Custom Default OK Cancel w ABI Severity Modification Form maf ABI Severity of Disease OK 1 3 Mon compressible To edit the text line double click the text line To 1 0 41 29 Normal Cancel 0 91
36. nected 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 The CHARGING indicator will turn off when charging is complete The Vantage ABI uses a 7 2 six cell Nickel Medal Hydride NiMH battery pack This battery pack has sufficient capacity to allow the product to be used for approximately 30 ABI exams The system charges a fully depleted battery in 3 hours After the charging is completed a maintenance charge sometimes called a trickle charge is applied When the remaining battery life is less than 15 minutes the yellow LOW BATT indicator on the front panel will flash When the battery life is severely depleted the flashing rate will increase At this point plug in the external power supply immediately to avoid losing any unsaved exam data NOTE The Vantage ABI will not print when the battery is low to ensure that there is no loss of data When operating from the external power supply the Vantage ABI will switch over to battery power automatically if there is a power outage NOTE Charging will not begin if the battery temperature is less than O C 32 F MANO0030 DFU Rev Ae 2 13 24 Wallach Surgical Devices Replacing the Battery Tool required Phillips head screwdriver To replace the battery use a Phillips head screwdriver to remove the battery
37. ntering a filename or patient identification e 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 e Touch CLEAR or BACK to make a correction or DONE when finished e After touching DONE the ABI main screen will appear to begin the exam NOTE During the exam data that is not saved will be lost when a new exam is started NEW ENTER NAME ID The last option under MENU OPTIONS is RESTORE BACKUP Touch this option to return to the exam you were performing prior to appearance of SYSTEM POWERDOWN e Touch RESTORE BACKUP in the event that the system powers off prior to saving the exam The previous exam will appear on the screen MANO030 DFU e Rev Ae 2 13 8 Wallach Surgical Devices Meaning of Symbols on Display Screen ABI Main Screen SITE DISABLED SITE COMPLETE Lf INCREASE THE PRESSURE LIMIT 180 IS THE DEFAULT PRESSURE amp 280 IS THE OPTIONAL PRESSURE L DECREASE THE PRESSURE LIMIT 60 IS THE DEFAULT PRESSURE amp 35 IS THE OPTIONAL PRESSURE t CUFFS INFLATING CUFFS DEFLATING SYSTEM IS CALCULATING NA ERRATIC WAVEFORM DETECTED NOT ANALYZABLE AR ABNORMAL RESULTS DETECTED PAD cannot be excluded MANO030 DFU e Rev Ae 2 13 9 Wallach Surgical Devices 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 s
38. ny other equipment e Confirm the setting of the real time clock prior to saving the patient data General Cautions CAUTIONS e U S Federal law restricts this device to sale by or on the order of a licensed practitioner e Patient movement including a cough sneeze and or talking may interfere with proper operation Patient must remain quiet during measurement e Read the Maintenance and Cleaning Section Section 11 before cleaning e The Vantage ABI may not measure systolic pressures effectively on patients who are experiencing tremors seizures or have moderate to severe arrhythmia e Do not drop or mishandle the Vantage ABI main unit or accessories Damage may occur e Use only the cuff type supplied by Wallach Surgical Devices Use of other cuff types will result in loss of accuracy NOTE The Vantage ABI and accessories do not contain latex MANO030 DFU e Rev Ae 2 13 2 Wallach Surgical Devices 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 The ABI is the standard exam used to assist in the diagnosis of
39. of the two brachial pressures ABI Assessment Above 1 30 Noncompressible Artery 1 00 to 1 29 0 91 to 0 99 Borderline equivocal 0 41 to 0 90 0 00 to 0 40 Severe Disease ACC AHA Guidelines for Management of Patients With Peripheral Arterial Disease 2005 Printing a File To print waveforms and pressures of the current exam simply press the PRINT button on the front of the main unit To print 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 or touch the exam you want to print and then touch VIEW After the selected exam appears on the screen press the PRINT button on the front of the main unit to print the waveforms and pressures Exporting a File to USB Stick To download patient data exam s select an exam and then touch EXPORT to export it to a USB flash drive for viewing on a personal computer PC An E will appear next to that exam indicating that it has been previously exported to the USB NOTE BE SURE THE USB MEMORY STICK IS PLUGGED INTO THE SYSTEM PRIOR TO DOWNLOADING ln EXAM MANAGEMENT touch the up arrow to scroll up through the list of saved exams Touch the down arrow to scroll down through the list Touch ALL to select all of the exams in the list Touch BACK to return to the ABI main screen MANO0030 DFU Rev Ae 2 13 14 Wallac
40. operated by trained personnel who have read all manufacturer supplied documentation e The Vantage Report software does not provide an interpretation of the examination results Results should be verified prior to performing additional procedures on the patient CAUTIONS e To ensure integrity of data on the user supplied external hardware the equipment should be backed up frequently e To ensure proper operation of the user supplied external hardware the equipment should run virus checking software and system diagnostics frequently e When the Vantage Report application is running the Windows Standby and Hibernate functions are disabled NOTE For security purposes and HIPAA guidelines data downloaded onto a USB flash drive memory stick can only be read using the Vantage Report application Getting Started Minimum Requirements Operating system supported only with a 64 or 32 bit Windows 7 Home Premium or better a 32 bit Windows XP Professional or a 32 bit Windows Vista Home Premium or better MANO0030 DFU Rev Ae 2 13 29 Wallach Surgical Devices Installation instructions Insert Vantage Report installing disk into CD ROM Drive Installation will start automatically and the following screen will appear ie YantageReport InstallShield Wizard Welcome to the InstallShield Wizard for YantageReport je tease Weed a VantageReport on your 1 When you be E in to install the Vanta ge Report software this screen will
41. ouch DELETE 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 SELECT YES OR NO TO CONTINUE Touch EXPORT to export the exam to use a USB flash drive for viewing on a personal computer PC NOTE BE SURE THE USB MEMORY STICK IS PLUGGED INTO THE SYSTEM PRIOR TO DOWNLOADING MANAGEMENT k 4 PAGE DOWN 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 BACK to return to the exam To save an exam touch SAVE EXAM from MENU OPTIONS and the alpha numeric keypad will appear for entering a filename or patient identification NOTE An exam will not be saved without assigning it a filename using the keypad Also an exam will not be saved if all 20 storage locations are currently full Touch SAVE EXAM under MENU OPTIONS to store the current exam in EXAM MANAGEMENT Use the alpha numeric keypad on the screen to enter a filename for the exam Touch CLEAR or BACK to make a correction DONE when finished or CANCEL to exit without changes After touching DONE the ABI main screen appears and the exam was saved under EXAM MANAGEMENT NOTE Any data not saved will be lost when a new exam is started MANO030 DFU e Rev Ae 2 13 7 Wallach Surgical Devices To begin a new exam touch NEW EXAM from MENU OPTIONS and the alpha numeric keypad will appear for e
42. tware and separated by tabs at the top of the application Select the appropriate tab to access or enter information C WantageReport Reports Sample Report Supine van Patient Into Pressure aveo Patient Info User editable information regarding the patient general comments and the examiner identification Pressures Waveforms Non editable pressure waveform and ABI information from the Vantage ABI downloaded file Patient Information Patient Info Tab Patient Name or ID will be transferred from the Vantage ABI file information and is shown in the Patient Info Tab Other information can be annotated at this time such as Patient Name Date of Birth Patient Name Date of Birth Age Sex LD Number Date Time Age Mr John Smith 03 10 1940 70 M 1234567890 11 09 10 14 52 29 Sex Interpreting Physician Referring Physician Dr Fred Jones Dr Joe Smith lt I D Number Date Time Interpreting Physician Interpreting Physician Referring Physician Unassigned Or Joe Smith Dr Fred Jones Patient Name or Patient ID will be exported directly from the Vantage ABI file information if it was saved on the device Risk Factors Risk Factors Tobacco Use Hypertension Check the appropriate boxes to enter the Diabetes Hyperlipidemia Hear Disease T Stroke TIA patient s P A D risk factors The Other section can be used for extra details such as pack years of smoking or
43. upine 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 Select the proper cuff width equivalent to 40 of the patient s limb circumference For most patients use the 10 cm cuff at the ankles and the 12 cm cuff at the arms CAUTION e Proper cuff size and placement are necessary to ensure accuracy of the ABI determination If the ankle cuff is too wide for the limb the ankle pressure measurement may cause Abnormal Results AR Proper placement of ankle cuffs Proper placement of the left arm cuff While applying the cuffs it may be a good time to explain the examination to the patient and answer any questions NOTE It is important that the patient remains still and supine for the duration of the exam Getting Started After the cuffs are wrapped around the patient s limbs turn on the Vantage ABI by pressing the ON OFF gray circular button on the main unit Connect each hose to its corresponding color coded port and connect the other end of the hose to the cuff as labeled MANO030 DFU s Rev Ae 2 13 10 Wallach Surgical Devices Color Coded Hose Connectors Right Ankle Left Ankle Right Arm SummitDpppler BLACK Right Ankle BLUE Left Ankle WHITE Right Arm
44. urface if cleaner is spilled onto touch panel soak it up immediately with absorbent cloth Cleaner must be neither acid nor alkali neutral pH Wipe the surface gently if there is a directional surface texture wipe in the same direction as the texture Never use acidic or alkaline cleaners or organic chemicals such as paint thinner acetone toluene xylene propyl or isopropyl alcohol or kerosene Suitable cleaning products are commercially available pre packaged for use one example of such a product is Klear Screen or commercially available off the shelf retail brands such as Glass Plus glass and surface cleaner Use of incorrect cleaners can result in optical impairment of touch panel and or damage to functionality NOTE Most products contain 1 3 Isopropyl Alcohol by volume which is within acceptable limits for Resistive Touch Panel cleaning use MANO0030 DFU Rev Ae 2 13 22 Wallach Surgical Devices CAUTION e 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 Maintenance CAUTION e If the Vantage ABI is to be stored for longer than 9
45. xplanation Of SVMDOIS TTT 41 MANO030 DFU e Rev Ae 2 13 i Wallach Surgical Devices Section 1 Introduction 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 sal Here s how you can reach us Phone 1 800 243 2463 203 799 2000 Fax 203 799 2002 e mail us at customerservice wallachsurgical com visit our website at www wallachsurgical com Important Please read this manual carefully and become familiar with the features operations care and safety requirements of the Vantage ABI prior to use Vantage ABI Package Contents Model VANMAX User Manual 5 Caster Roll Stand with Storage Basket ABI Chart Power Supply 7VDC amp Cable 10cm Cuffs 2 Built In Printer 12cm Cuffs 2 4Hoses ABI Report Forms PC Download Software Training Video USB Memory Stick Model VANABI User Manual Power Supply 7VDC amp Cable ABI Chart Training Video 10cm Cuffs 2 4Hoses 12cm Cuffs 2 USB Memory Stick PC Download Software A carrying case for the V
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