Vantage™ ABI user manual
Contents
1. Emea POF Trpin Ditor Sy jC Warlageiepom UF DICOH Espos Dicia Eep DICOM F aciity Indo ABI Savery Chat This screen allows the user to enter physician names to be used for referring or interpreting physician on the patient information tab Select Add to enter a new name Please Enter Hame a Enter the information in the fields and click Ok retin or Given Steve Middle E Family M epers Suffis E Uk Cancel Vantage ABI User Manual Page 38 The screen allows a user to customize the severity table shown in the report The default is Simcoe from the ACC AHA guidelines To customize ft A S0 Mocha ko bk select Custom 00 040 Geo sess ruti w AGI Severity Modification Form ABI Severity of Disease 1 3 Non compressible 1 0 1 29 Normal 0 91 0 99 Borderline 0 41 0 90 Moderate to Mild i i en a a To edit the text line double click the text line To delete the text line right click the text line To edit text line e e e aedihelai To add a new line click on New Line and left To delete text line click and drag to a new location Press Ok Right click text line and select Delete when editing a line of text To add a new line Click on Mew Line box below Left click and drag to new location Edit Text The screen to the left will appear Click ok when Cancel complete Vantage ABI User Manual Page 39 Importi2. 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 Vantage ABI User Manual Page 32 Section 15 Vantage Report Report Generation Software The Vantage Report software allows a 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 WARNING 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 WARNING The Vantage ABI shall not be connected to the user supplied external hardware during an examination WARNING The Vantage ABI and Vantage Report software shall be operated by trained personnel who have read all manufacturer supplied labeling WARNING The Vantage Report software does not provide an interpretation of th
3. by selecting MAN for WAVEFORMS under the System Settings menu the clinician manually controls pumping the cuffs changing the scale saving the waveform and selecting DONE to move to the next site to be completed See Section 7 of this manual 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 Vantage ABI User Manual Page 14 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 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 a
4. o 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 o Touch the box of the exam that you would like to select o Touch VIEW to view the exam selected o Touch 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 o 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 EXAM MANAGEMENT CED IMMM WIEW 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 O O O O 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 Vantage ABI User Manual Page 10 o 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 o Touch CLEAR or BACK to make a correction DONE when finished or CA
5. I i I I I i aren a Dolor saad iy I I i I I J I I I I i I a ee here ae I i I I I i bF 4 F I I i I I I Li I 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 Vantage ABI User Manual Page 23 Section 10 Maintenance and Cleaning Cleaning Precautions WARNING 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 Use only the recommended spray or wipe cleaners and disinfectants see Cleaning and Disinfection below WARNING The Vantage ABI is not designed for sterilization processes such as autoclaving or irradiation WARNING 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 by warm water or with pre saturated isopropyl alcohol wipes or spray such as Transeptic from Parker Laboratories Inc Be sure to clean carefully along any
6. NOTE Most products contain 1 3 Isopropyl Alcohol by volume which is within acceptable limits for Resistive Touch Panel cleaning use 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 of this manual Maintenance CAUTION If the Vantage ABI is to be stored for longer than 90 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 Summit Doppler Systems for calibration if needed See Section 12 of this manual 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
7. 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 In 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 Vantage ABI User Manual Page 16 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 of this manual for preparing the patient On the main screen touch t
8. 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 CONNECTORS PORTS COLOR CODED a 5 R SummitDpppler BATTERY CHARGE CONNECTOR PORT Vv Vantage ABI User Manual Page 7 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 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 MENU OPTIONS F SYSTEM SETTINGS Ba FILE MANAGEMENT 3a SAVE EXAM GB E exan Ci RESTORE BACKUP Vantage ABI User Manual Page 8 By selecting SYSTEM SETTINGS the System Settings menu appears that allows for customizing the system Touch BAC
9. of the interference or increase the distance between the Vantage ABI and the source of the interference WARNING 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 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 240VAC 50 60Hz 1 2 Amp Output 7VDC 5A Use only the following external supplies Globtek model GTM 21097 4509 2 0 SL Power Ault model MW160A703F01 These supplies are available as Summit PSA0004 Recharge Time 3 Hours A Consult Accompanying Documents ENVIRONMENTAL Operating conditions Temp 10 30 C Humidity 30 75 non condensing Transport amp Storage Conditions Temp 20 to 50 C Humidity 5 90 non condensing Vantage ABI User Manual Page 29 Section 13 Troubleshooting Service and Warranty Troubleshooting WARNING Use alternate equipment in case of unit failure Call Summit Doppler Systems Service Department if the unit or probes malfunction WARNING Risk of Electric Shock the Vantage ABI contains no user serviceable components Only qualified personnel should at
10. 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 Vantage ABI User Manual Page 19 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 The exam screen will appear to begin the new exam Exam Restore Backup To restore an exam that you were performing prior to power down 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 ch
11. 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 become more pronounced during vasoconstriction SAMPLES OF NORMAL PVR WAVEFORMS ABI of 1 15 I TLE TLE TLE I i l I I E EI I E F I ML ML E Pe oe Peake VP ll Ie che ly ell I ABI of 1 24 SAMPLE OF A BORDERLINE PVR WAVEFORM ABI of 96 Vantage ABI User Manual Page 22 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 lt I I I _ ABI of 82 i I I i I I I EER Ee EE I I I i I I F 4 F i I I I i I pa ep a
12. ARNING This device is not intended for use with HF surgical equipment General Warnings WARNING 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 WARNING The Vantage ABI is for use by qualified personnel only Read the User Manual before use WARNING Carefully route all cables and tubing to reduce the possibility of patient entanglement or strangulation WARNING Do not allow the patient to operate any portion of the equipment WARNING Do not place the equipment in any position that would allow it to roll fall or collide with a user or patient WARNING 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 WARNING Do not connect Luer fittings from Summit Doppler equipment into any other equipment WARNING Confirm the setting of the real time clock prior to saving the patient data General Cautions CAUTION Federal law restricts this device for sale by or on the order of a licensed practitioner CAUTION Patient movement including a cough sneeze and or talking may interfere with proper operation Patient must remain quiet during measurement CAUTION Read the Maintenance and Cleaning Section of this manual Section 11 before cleaning CAUTION The Vantage ABI may not measure syst
13. K to return to the ABI main screen SET CLOCK SET CONTRAST AUTO POWERDOWN AUTO INFLATION Z WAVEFORMS AUTO Under System Settings o 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 o Touch SET CONTRAST to adjust the display contrast Continue touching tapping until the contrast is optimum o 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 o 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 both the arm and the ankle cuffs on one side of the patient will be inflated simultaneously Vantage ABI User Manual Page 9 o 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 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
14. NCEL to exit without changes o 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 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 o 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 o Touch CLEAR or BACK to make a correction or DONE when finished o 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 The last option under Menu Options is RESTORE BACKUP Touch this option to return to the exam you were performing prior to system power down appears o Touch the RESTORE BACKUP in the event that the system powers off prior to saving the exam The previous exam will appear on the screen Vantage ABI User Manual Page 11 Meaning of Symbols on Display Screen ABI Main Screen SITE DISABLED SITE COMPLETE L INCREASE THE PRESSURE LIMIT 180 IS THE DEFAULT amp 280 IS OPTIONAL L DECREASE THE PRESSURE LIMIT 60 IS THE DEFAULT amp 35 IS OPTIONAL CUFFS INFLATING CUFFS DEFLATING SYSTEM IS CALCULATING NA ERRATIC WAVEFORM DETECTED NOT ANALYZABLE AR ABNORMAL RESULTS DETECTED V
15. NE Similarly if the pressure limit is to be decreased an LW will appear at the site and the pop up warning will also appear Touch the limit option on the screen to change the pressure limit and then touch LIMIT There are two options for decreasing the pressure limit 60 is the standard and 35 is the optional limit Touch a selection and then touch BACK to return to the previous screen To return to the ABI main screen touch DONE Obtaining an Ankle Waveform Manually 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 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 Vantage ABI User Manual Page 18 SAMPLE OF THE DISPLAY SCREEN ABI MAIN SCREEN AFTER COMPLETING EXAM R js di 66 i i anhs LOS l SI ants PUR AHE mmHa 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
16. Symptoms ABI Severity of Disease I Tobacco Use C Hypertension I Intermittent Claudication 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 C Diabetes C Hyperlipidemia L Numbness Tingling in Feet C Buttocks I Heart Disease LI Stroke TIA L Ulcerations LI Thigh C Previous CV Event J Prev Vascular Surgery LJ Rest Pain CL Calf L Gangrene I Feet Interpreting Physician Dr Steve E Meyers Sr Referring Physician Dr Fred Jones Comments Exam performed by Sheila RIGHT LEFT Brachial Brachial 120 125 mmHg mmHg Ankle Ankle 141 139 mmHg mmHg 1 11 Index 1 12 Index oo os 10 15 20 25 30 35 40 oo Os iD 15 20 25 30 35 40 Seconds Seconds Interpretation Normal ABI Results Vantage ABI User Manual Page 42 Example of data from a comma delimited file TitleLine1 Lower Extremity Physiologic Study TitleLine2 Single Level ABI Exam PatientName Mr John Smith PatientID 1234567890 Comments Exam performed by Sheila Location Right Brachial Location Left Brachial BrachialRight 120 BrachialLeft 125 Location2Right Ankle Location2Left Ankle Location2PressureRight 141 Location2PressureLeft 139 IndexRight tke IndexLeft gs WaveformScaleRight PVR X1 WaveformScaleLeft PVR X1 WaveformTimeStampRight 11 9 2010 14 51 WaveformTimeStampLeft 11 9 2010 14 51 PatientAge 70 Date 11 9 2010 14 52 FacilityName Vasc
17. VANTAGE ABI USER MANUAL Summit Doppler Systems Inc 4680 Table Mountain Drive 150 Golden CO 80403 800 554 5090 or 303 423 7572 Fax 303 940 7165 www summitdoppler com Vantage ABI User Manual Table of Contents Section 1 Section 2 Section 3 Section 4 Section 5 Section 6 Section 7 Section 8 Section 9 Section 10 Section 11 Section 12 Section 13 Section 14 Section 15 Introduction Safety Information Description of Product and Controls Preparing the System for Use Menu Configuration and Set Up Performing the ABI Exam Obtaining Pressures and Waveforms Manually Exam Management Pulse Volume Recording PVR Waveform Interpretation Maintenance and Cleaning Battery Recharging and Replacement Specifications Troubleshooting Service and Warranty Clinical References Vantage Report Software Vantage ABI User Manual Page 2 Section 1 Introduction Thank you for choosing the Vantage ABI from Summit Doppler Systems Inc 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 Summit Doppler Systems Inc 4680 Table Mountain Dr 150 Golden CO 80403 USA Phone 1 800 554 5090 or 1 303 423 7572 Fax 1 303 940 7165 Em
18. ail sales summitdoppler com Visit our website at www summitdoppler 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 2011 Summit Doppler Systems Inc All rights reserved No one is permitted to copy or reproduce in any form all or any portion of this manual without the permission of Summit Doppler Systems Inc Vantage ABI Vantage Report and Listening to Life are trademarks of Summit Doppler Systems Inc Transeptic is a registered trademark or Parker Laboratories Inc Precise is a registered trademark of Caltech Laboratories Inc 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 C E 0470 Authorized Representative NOVAMEDICA Ign Tsakalidis S A U S Patents Pending 6 kim Thermi Charilaou Str Thessaloniki GREECE MANOO030A Vantage ABI User Manual Page 3 Section 2 Safety 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 WARNING This device is for use only on or near intact skin WARNING This device is not intended for pediatric or fetal use W
19. antage ABI User Manual Page 12 Section 6 Performing the ABI Exam Preparing the Patient In a warm room have the patient take off their 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 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 Proper cuff size and placement are necessary to insure 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 remain 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 Vantage ABI User Manual Pa
20. aracter 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 exam 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 the 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 print 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 Vantage ABI User Manual Page 20 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
21. 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 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 Vantage ABI User Manual Page 21 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
22. e examination results Results should be verified prior to performing additional procedures on the patient CAUTION To ensure integrity of data on the user supplied external hardware the equipment should be backed up frequently CAUTION To ensure proper operation of the user supplied external hardware the equipment should run virus checking software and system diagnostics frequently CAUTION 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 can onl 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 and a 32 bit Windows Vista Home Premium or better Installation instructions Insert Vantage Report installing disk into CD ROM Drive Installation will start automatically and the following screen will appear Vantage ABI User Manual Page 33 ie YantageReport InstallShield Wizard Welcome to the InstallShield Wizard for YantageReport The InstallShield R Wizard will install YantageReport on your computer To continue click Next 1 When you begin to install the Vantage Report software this screen will appear Select Next to continue the installation WARNING This program is protected by copyright law and interna
23. e 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 Vantage ABI User Manual Page 40 Entera 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 Vantage ABI User Manual Page 41 Completed Sample ABI Report in PDF File Format Lower Extremity Physiologic Study Vascular Clinic Single Level ABI Exam 123 Main St Ft Collins CO 80123 Patient Name Mr John Smith Patient DOB 03 10 1940 Patient Sex M PatientID 1234567890 Age 70 Exam Date 11 09 10 14 52 29 Risk Factors Current
24. ely 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 0 C 32 F Replacing the Battery Tool required Philips head screwdriver To replace the battery use a Philips 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 alo BATTERY REPLACEMENT USE ONLY SUMMIT DOPPLER TYPE B200 i US PATENTS PENDING Vantage ABI User Manual Page 26 CAUTION Use only replacement battery packs as specified by Summit Doppler Systems Inc The battery pack contains a temperature measurement component that is matched to the cell type and to the product requirements CAUTION Unauthorized battery substitutions will void the warranty and may cause overheating CAUTION Used NiMH batteries must be recycled or disposed of properly Do no incinerate CAUTION Use only an external power adaptor as specified b
25. em 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 of this manual 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 240VAC Controls and Indicators Main Unit ON OFF Turns the unit on or off with momentary actuation FEED D FEED Printer feeds paper while pressed PRIN PRINT Prints out the labels for the current exam Vantage ABI User Manual Page 5 LOW BATT CHARGING On Charging Flashing Charging complete trickle charging chance E while flashing LOW BATT Flashing Low battery PRINTER PAPER RELEASE Gray bu
26. ge 13 Color Coded Hose Connectors Right Ankle Left Ankle Right Arm SummitDoppler 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 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 Hoses must be connected to the proper limb as indicated in Preparing the Patient 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
27. he 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 Vantage ABI User Manual Page 17 If the system requires that a pressure limit be increased an L will appear as well as a pop up warning as show below Select the Pressur and touch LIMIT to adjust the Pressure uF or down In this instance touch the limit option on the screen to change the pressure limit and then touch LIMIT There are two options for increasing the pressure limit 180 is the standard and 280 is the optional limit Touch a selection and then touch BACK to return to the previous screen To return to the ABI main screen touch DO
28. l be repaired or replaced in a reasonable amount of time Summit Doppler Systems liability for any claim is limited to materials and labor associated with repair or replacement In no event shall Summit Doppler Systems be liable for incidental or consequential losses or damages in connection with the purchase of this product Summit Doppler Systems disclaims all expressed or implied warranties agreements or arrangements other than issued in this warranty unless specified in writing and signed by the President of Summit Doppler Systems Summit Doppler Systems is not responsible for damages to the device that occur as a result of the inadequate shipping to Summit Doppler Systems 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 Summit Doppler Systems approved service technicians If you need to return the Vantage ABI or one of its components or accessories for repair 1 Call Summit Doppler Systems at 1 800 554 5090 to obtain a Return Authorization RA and any special instructions prior to shipping 2 Clean the product before 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 After contacting Summit Doppler send the product to Service Department Summit Dopple
29. moking or date of previous CV event Other Vantage ABI User Manual Page 35 Current Symptoms Current Symptoms yp D Intermittent Claudication Location Check appropriate boxes to enter the I Numbness tingling in teet Buttocks patient s P A D symptoms and the locatior Uicerations E u z Rest Fain Calf of the symptoms The Other section can r Gangrene Feet be used for extra details such as when or Other how often symptoms occur Comments Examiner Comments p 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 Citas pate Fipa anpii Pagari Tujiem past Pitertinds Pitruretalaeioen Baleni Pla ih Loh whi Lower Extremity Physiologic Study Single Level ABI Exam ok Arm and Ankle Pressures pea Brachi i Brachial Reference ABI Table eielon t Ee a s D urea i D SY mmbtig ji a Ankle 139 mmHg 1 11 ABI Value PVR Waveforms Haaai HA 5 ThA 1 St Vantage ABI User Manual Page 36 Managing a Report File Menu Preferences Windows About Oper Open Save ort Repor
30. n Touch DONE to return to the ABI main screen and then touch PUMP to retake the pressure Vantage ABI User Manual Page 15 The symbol NA means the signal is not analyzable NA may be due to patient and or cuff movement during deflation In this case a new pressure should be taken 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 NOTE To retake any measurement select the site and touch PUMP The symbol AR means abnormal results were detected and the pressure cannot be determined In this case verify that the cuff is the correct width for the limb and that the cuff is wrapped sufficiently tight 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 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
31. ng a Report File To import a file from a USB insert a USB disk and select Import for 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 Sclioct Vantage Dala File Select Exams 09 07 10 15 35 59 09 07 10 15 41 53 09 07 10 15 46 57 09 07 10 15 48 49 09 07 10 15 49 04 09 07 10 15 49 28 09 07 10 15 49 44 09 07 1015 49 59 Indicates that the exam was previously exported from the Vantage ABI Select All Select None Fiet of type arias Chak Fikes ta FF Open as maori i 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 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 lorthReports ample Report Supine van Close SAVE a5 Import eure avelorms Export and Launch Acrobat Adobe Acrobat pdf Export Print Print Preview Export Report File Only Printer Select Ex Fame _ Date of Birth Adobe PDF 2 Options 1 Select File gt Export gt Adobe Acrobat pdf gt Export and Launch Acrobat to immediately view the PDF fil
32. olic pressures effectively on patients who are experiencing tremors seizures or have moderate to severe arrhythmia CAUTION Federal law restricts this device for sale by or on the order of a licensed practitioner CAUTION Do not drop or mishandle the Vantage ABI main unit or accessories Damage may occur CAUTION Use only the cuff type supplied by Summit Doppler Systems Inc Use of other cuff typed will result in loss of accuracy Note The Vantage ABI and accessories do not contain latex Vantage ABI User Manual Page 4 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 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 of this manual The syst
33. plication Select the appropriate tab to access or enter information C WantapeReport Reports Sample Report Supine van Patient Info PressureWavetorms 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 are shown in the Patient Info Tab Other information can be annotated at this time such as Patient Name i Patient Name Date of Birth Age Sex I D Number Date Time Date of Birth Age Mr John Smith 03 10 1940 70 M 1234567890 11 09 10 14 52 29 Interpreting Physician Referring Physician Sex Dr Fred Jones Dr Joe Smith v I D Number Date Time Referring Physician Interpreting Physician Interpreting Physician HU n Assigned Un Assigned Or doe Smith Or 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 M Tobacco Use Hypertension Diabetes Hyperlipidemia Check the appropriate boxes to enter the w ae Poo patient s P A D risk factors The Other M Previous CW Event 7 Previous Vascular Surgery section can be used for extra details such as pack years of s
34. r Systems Inc 4680 Table Mountain Dr Unit 150 Golden CO 80403 Vantage ABI User Manual Page 31 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 Society for Vascular Medicine and Biology and the American College of Cardiology American Heart Association Task Force on Practice Guidelines 2005
35. 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 such as Precise QTB from Caltech Industries Inc Follow the instructions provided with the disinfectant and be sure to wipe the unit dry when finished Touch Screen Cleaning Information e Use a soft lint free cloth e The cloth may be used dry or lightly dampened with a mild cleaner or Ethanol e Be sure the cloth is only lightly dampened not wet Never apply cleaner directly to touch panel surface if cleaner is spilled onto touch panel soak it up immediately with absorbent cloth e Cleaner must be neither acid nor alkali neutral pH e Wipe the surface gently if there is a directional surface texture wipe in the same direction as the texture e Never use acidic or alkaline cleaners or organic chemicals such as paint thinner acetone tolulene xylene propyl or isopropyl alchohol or kerosene e 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 made by Reckitt Benckiser e Use of incorrect cleaners can result in optical impairment of touch panel and or damage to functionality Vantage ABI User Manual Page 24
36. t 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 Exam 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 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 The symbol Lf indicates that the initial inflation was not high enough to capture the signal To raise the inflation limit and take another pressure touch the site on the screen and then touch LIMIT Touch a selection to make the pressure limit adjustment After changing the upper limit touch BACK to return to the previous screen Touch DONE to return to the ABI main screen and then touch PUMP to retake the pressure The symbol LW indicates that the initial deflation was not low enough to capture the signal To lower the 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 After changing the lower limit touch BACK to return to the previous scree
37. tempt to service the unit CAUTION Do not drop or mishandle the Vantage ABI and accessories Damage may occur Vista AVS 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 flash is connected Unit shuts off Power Down is set to ON or battery is low Printed waveform differs from The printed waveform always includes two additional seconds of displayed waveform waveform 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 Vantage ABI User Manual Page 30 Warranty and Service Information Summit Doppler Systems Inc is pleased to offer our customers with a 30 day no hassle evaluation return policy in the event that you are not satisfied with our product The Vantage ABI is warranted against defects in material and workmanship for 12 months from the original sale of the device 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 Summit Doppler Systems Products shal
38. tional treaties iw 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 exit the wizard Current Settings Setup Type Typical 2 Select Install to load to the Vantage Report Destination Folder C Program Files Summit Doppler VantageReport S oftw are program to your compu ter User Information Name Neil D Company Summit Doppler Systems InstallShield iw YantageReport InstallShield Wizard Installing antageReport The program Features you selected are being installed 3 This screen appears as the installation is in process Please wait while the InstallShield Wizard installs VantageReport This may take several minutes Status Writing system registry values InstallShield ie YantageReport InstallShield Wizard InstallShield Wizard Completed 4 Select Finish to complete the installation process The InstallShield Wizard has successfully installed _ VantageReport Click Finish to exit the wizard Cancel Vantage ABI User Manual Page 34 Starting Vantage Report If the installation was completed properly an application icon is already on 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 ap
39. to the optional roll stand s pole at least annually In order to preserve protect and improve the quality of the environment protect human m 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 or Summit Doppler Systems to dispose of equipment Vantage ABI User Manual Page 25 Section 11 Battery Recharging and Replacement The external power supply Summit Doppler catalog B200 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 7 VDC POWER connector The green CHARGING indicator is held 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 sometime 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 sever
40. tsam Allows the user to open a previously Close saved report Save as Import sure Waveforms Export Print Save Save As 3 Print Preview Allows the user to select the report name 3 Printer Select and location for later recovery and backup Exit Name 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 below 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 Vantage ABI User Manual Page 37 Preferences Menu ABI Seventy Chat ides This screen allows the user to enter facility reste adi information that will be included in the report Pare Coen 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 AHI Seventy heat ee The File Paths menu allows the user to ee a select a default directory for each file Vania Imperl ersoy D Ck format to save exams CIW Epot Dieto
41. tton on left panel opens up the printer door 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 Valu Time Date Stamp Touch for Help Options MENU Touch for Menu Options Vantage ABI Package Contents Model VANMAX Manual Power Supply 7VDC amp Cable ABI Chart 5 Caster Roll Stand with Storage Basket 10cm Cuffs 2 Built In Printer 12cm Cuffs 2 4Hoses ABI Report Forms PC Download Software Training Video USB Memory Stick Roll Stand with Storage Basket Model VANABI 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 Vantage ABI main unit is optional and sold separately Vantage ABI User Manual Page 6 Section 4 Preparing the System for Use 1 Review the unit and locate each of the controls and connectors see Section 3 of this manual 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
42. ular Clinic FacilityAddr 123 Main St Ft Collins CO 80123 Interpretation Normal ABI Results InterpretingPhysician Dr Steve E Meyers Sr ReferringPhysician Dr Fred Jones PatientDOB 3 10 1940 PatientSex M Vantage ABI User Manual Page 43
43. y Summit Doppler Systems Inc Vantage ABI User Manual Page 27 Section 12 Specifications CLINICAL Cuff Pressure Range 0 to 280 mmHg Pressure Gage Accuracy 3 mmHg 0 200 mmHg 2 gt 200 mmHg 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 90 Clinical Specificity gt 92 1 See page 18 for information on selecting alternate inflate deflate limits 2 Specified time is typical for measuring four limb pressures between 50 and 170 mmHg 3 Doppler ABI and PPG TBI were the references for determining Sensitivity and Specificity MECHANICAL Main Unit Dimensions 6 4 inch x 11 inch x 7 3inch 16 25x27 9x18 5 cm HxWxD Main Unit Weight 4 6 Ibs 2 1 Kg Mounting Self supported rubber feet or stand mounted optional Portability Built in carry handle Vantage ABI User Manual Page 28 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
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