Home

User Manual for Vista ABI

1. POLL Data Download On the Vista ABI OPTIONS menu select FILE and DOWNLOAD to transfer data that is currently active The AVS Report software will briefly indicate Upload Success to verify that the data was accepted 12 26 2006 2 05 PM Connected Upload Success MANO024 DFU Rev A 5 13 47 Wallach Surgical Devices If a transmission error occurs the report software screen will indicate that the data verification failed Check to ensure the USB cable is securely connected on both ends and download the file again Contact Wallach Surgical Devices if the error continues to occur AYSReport Data Verification Failed Please try uploading again Report data is segmented into 4 Sections of the software and separated by tabs at the top of the application Select the appropriate tab to access or enter information 4 CASummitDoppler Reports ISTA AVS avs Patient Info Pressures Waveforms CPT ICDS Codes 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 Vista ABI downloaded file CPT ICD9 Codes User editable billing information to appear on the report Patient Information Patient Info Tab Patient Name or ID will be transferred from the Vista ABI instrument and are shown in the Patient Info Tab Other information can be annotated at this time such as P
2. Rev A 5 13 32 Wallach Surgical Devices Preferences Menu Allows the user to enter facility information that will be included in the report such as facility name and address This information will be stored in the application and used on each subsequent report that is generated until the information is changed The File Paths menu allows the user to select a default directory for each file format to save exams Preferences Preterences Facility inia Facility fos Fady Hare Vascular ine IEEE AWS Pepo Directoy E Wantageneport A epoets Factity Addi Leoni yere Vantage Import Denrtony T 3ManSE aa pegar Ft Cala LO GUIZI z ManiageFinpor apais CoV Fnit Darcinay IE aniageB epos LEV PDF Expos Directong EW anayen eat PDF DILLIM Export Decoy E Mantagefienon DICTI The above screen allows the user to enter facility information that will be included in the report such as the facility name and address This information will be stored in the application and used on each subsequent report that is generated until the information is changed The File Paths menu allows the user to select a default directory for each file format to save exams Preferences Please Enter Mame Facdiyinio File Pals Physician Lint ABI Sooty Chart Di dese Soils Dr Fred Jones Frefix Dr Given Steve Middle E Family Meyers Suffix The above screen allows the user to enter Enter the information in the fields and
3. 51 Se Po Seconds 2g Becinds 25 Seconds 93923 Non invasive physiologic studies of upper or lower extremity arteries multiple level bilateral ICD 9 Code 440 23 Atherosclerosis of native arteries of the extremities with ulceration Wallach Surgical Devices Example of data from a comma delimited file SubTitle Ankle Brachial Index Assessment Form PatientName John Smith PatientlD 123 45 6789 Severity ABI Severity Severity 1 0 90 1 30 Normal Severity2 0 70 0 89 Mild Severity3 0 40 0 69 Moderate Severity4 0 0 0 39 Severe Results ABI Results Comments Right side P A D Spoke to patient re life style modifications Recommend further evaluation CPTCode 93922 Non invasive physiologic studies of upper or lower extremity arteries single level bilateral ICD9Code 440 21 Atherosclerosis of native arteries of the extremities with intermittent claudication RightSite PT LeftSite PT RightProbe 8 MHZ LeftProbe 8 MHZ ABIRightArm 154 ABILeftArm 148 ABIRightToeAnkle Right Ankle ABIRightTA 96 ABILeftToeAnkle Left Ankle ABILeftTA 158 LeftTAP Left Ankle Pressure RightTAP Right Ankle Pressure LeftT APVal 158 RightTAPVal 96 HAPValue1 154 HAPValue2 154 LeftABlValue 1 02 RightABlValue 0 62 PatientAge 67 Date 12 27 06 10 02 54 RiskOther 2 pack per day smoker oymptomOther Max walking distance 1 block HospitalName ot Joseph HospitalAddr 1234 Main Golden SummitAddr 4680 Tabl
4. File Annotation The File Management SAVE function can use either alpha or numeric characters for saving a patient filename To configure the system to the desired function l 2 5 4 Press the ENTER MENU key to open the OPTIONS menu Press the number 2 key to select the SYSTEM SETTINGS Press the number 4 key to toggle between NAME or NUMBER modes To enter a filename use the alphanumeric keys on the hand held controller Use the DOWN key to backspace and the UP key to move between different letters on the same button Press the SAVE key to save the filename and begin the exam MANO024 DFU Rev A 5 13 13 Wallach Surgical Devices Selecting a Modality for Obtaining Pressures Choose between the Doppler probe or if purchased separately the photoplethysmography PPG probe to obtain pressure values for ankle brachial index ABI exams toe brachial index TBI exams or segmental studies 1 Press the ENTER MENU key to open the OPTIONS menu 2 Press the number 2 key to select the SYSTEM SETTINGS 3 Press the number 6 key to toggle between DOPPLER and PPG The selected pressure modality is indicated in the lower right corner of the display DOP or PPG will appear depending on which is selected as shown below Wa ee ee eee R45 28121141 site amp obtain waveform signal Press and hold PUN P to in L t Or enter Pressure from ke Modality Doppler probe VISTA TIP e Ifyou re trying to obtain press
5. the UP or DOWN keys will scroll the waveform Press SAVE to store the waveform and then use the UP key to adjust the site label PT DP TOE BRA Press SITE or SAVE again to store these values and move to the R ANK right ankle location MANO024 DFU Rev A 5 13 19 Wallach Surgical Devices OBTAINING PVR WAVEFORMS VISTA TIP e Ifyou pump over 75 mmHg pressure the unit will automatically deflate to 65 mmHg Note that the audio will be off or muted while in the PVR mode e You may want to consider setting the scale to PVR x 2 to view the waveform This is done by pressing SCALE on the hand held controller to change the view of the display To obtain the PVR waveform from the ankle wrap the proper size cuff see the beginning of this section Preparing the Patient for proper cuff selection around the ankle Move the cursor to the Right WAV site and use the PUMP control to inflate the ankle cuff to 65 mmHg or slightly higher It will take several seconds for the position of the waveform to settle out and return to the center of the display After the waveform stabilizes press the FREEZE key Here you have two options if the waveform is acceptable press SAVE to record it Or you can use the UP or DOWN key to scroll to the optimum waveform Press SITE or SAVE again to move to the R ANK right ankle location xd PVR Waveform em z3 pm ce m LL m a a E E E un uc T peo Location Ri
6. A significantly reduced ankle pressure results in a low 0 9 ABI value which indicates P A D Systolic ankle pressures are obtained with a pressure cuff and audio Doppler probe ABI measurements are discussed in detail in Section 6 A single level lower extremity arterial exam CPT 93922 includes the ABI pressures calculated index and arterial physiologic waveforms Two types of waveform modalities are provided on the Vista ABI continuous wave CW bi directional Doppler and PVR Both of these waveform modalities meet the requirements of CPT 93922 Although both modalities have significant clinical utility it is generally not necessary to include both PVR and Doppler waveforms in reimbursement documentation for CPT 93922 either one 1s sufficient Waveform analysis is discussed in Section 10 The Doppler waveform is a graph with a vertical axis Doppler frequency shift or pitch proportional to the velocity of arterial blood flow Flow toward the probe is indicated above the baseline Flow away from the probe is indicated below the baseline The 8 MHz bi directional probe is best for superficial vessels and all around use The optional 5 MHz bi directional probe is used for deeper vessels and with some obese patients Pulse Volume Recording PVR is a form of plethysmography which is an indirect method of limb volume measurement A pressure cuff 1s applied to the limb and inflated to 65 mmHg to detect the minute fluctuations in limb
7. a File To save an exam press the ENTER MENU key to open the OPTIONS screen Press the number 3 key to select FILE MANAGEMENT Press the number 1 key to save the current exam There are 10 storage locations that retain data if all power is lost Select the number of an unused file storage location this location will be highlighted Use the alphanumeric keys on the hand held controller to enter a patient filename Use the DOWN key to backspace Use the UP key to move between different letters on the same button Press SAVE to save the file After saving the system returns to the main screen If the system was powered down prior to saving data the FILE RESTORE message will appear on the display upon power up see image below Pressing the ENTER MENU key will remove the message and allow the user to start a new exam or recall the previous unsaved patient data by accessing Restore Data Powering down a second time will not repeat the message even if the restored file 1s still stored gt Use the Pil aP the cuff at the selected tain waveform signal hold PUMP to inflate Pressure from keypad NOTE When saving an exam the SAVE and ENTER MENU keys perform the same function Either key can be pressed to save an exam file If the user saves an exam under FILE MANAGEMENT by entering a patient name or ID and turns off the power before pressing the SAVE or ENTER MENU key the system will automatically complete the save function befor
8. and safety requirements of the Vista ABI prior to use Please note that while operating the Vista ABI step by step instructions are shown on the display to assist you through the examination Wallach Surgical Devices provides general reimbursement information related to the diagnosis of peripheral arterial disease as an overview for our customers It is important to understand that reimbursement is a complex process and requirements are subject to change without notice It is the responsibility of the healthcare provider to determine and submit appropriate codes charges and modifiers for services that are rendered Prior to filing any claims customers are advised to contact their third party payers for specific coverage coding and payment information Wallach Surgical Devices makes no promise or guarantee of reimbursement by Medicare or any other third party payer EMERGO EUROPE Molenstraat 15 Coo 86 S a U S Patent Pending The Netherlands Package Contents The Vista ABI unit includes the following User Manual 2 cm Cuffs 2 Training Video ABI Chart Printer Paper 8 MHz Bi Directional Probe Hand Controller Hose Set Stand with Basket amp Knobs L450VA only Ultrasound Gel ABI Report Forms Tape Measure 10 cm Cuffs 2 USB Cable Power Supply 7 VDC amp Cable The following are optional and sold separately from the Vista ABI 5 MHz Bi Directional Probe PPG Probe Carrying case AVS R
9. configuring a medical system and the user is responsible for ensuring the overall system compliance Connected equipment must be certified to the applicable IEC standard 1 e IEC 950 for data processing equipment IEC 60601 1 for medical equipment Contact the technical service department for more information MANO024 DFU Rev A 5 13 2 Wallach Surgical Devices General Cautions CAUTIONS Do not plug the probe cables into a telephone system computer or any equipment other than the Vista ABI Read the Maintenance and Cleaning Section Section 11 before cleaning e U S Federal law restricts this device to sale by or on the order of a licensed practitioner Do not drop or mishandle the Vista ABI main unit probes hand controller or other accessories Damage may occur Limitations of Noninvasive Vascular Tests In Current Noninvasive Vascular Diagnosis Chapter 13 Page 208 Ali F AbuRahma and Edward B Diethrich note the following limitations of arterial leg Doppler examinations Falsely high segmental pressure readings in areas with calcified arteries e Artificially elevated high thigh pressure in very large or obese patients Difficult interpretation of segmental pressures in patients with multilevel occlusive disease e Difficulty in interpretation of high thigh readings False negative results in patients with mild vascular occlusive disease who have normal resting ankle pressures Safety of Ultrasound Th
10. or from the examiner Pressures Waveforms and ABI Values Pressures Waveforms Tab The ankle and brachial pressures download from the Vista ABI are included in the Pressure ABI Tab along with the modality used to take the pressures Doppler or PPG A reference table is also displayed for either ABI or TBI clinically accepted values as an aid for the clinician in determining a diagnosis MANO024 DFU Rev A 5 13 49 Wallach Surgical Devices ABI Exam Pater Hime Map Jono Lower Extremity Physiologic Study Single Level ABI Exam Arm and Ankle Pressures E 1 Nan cormpneible Rig ht Left 10 1 29 Konrad Brachial Brachial Reference ABI Table iie js eps m DO 040 Severe mmHa is FT FT 1 09 135 138 12 Index mmHg mmHg Index DP DP 1 07 132 143 1 16 Isid mmHg mmg Index 1 09 Higher ABI 116 q ABI Value Modality Index a Index PVR Trier no rs Po hg PR IZ str DD ea 1 e i j l i l A i Seated ABI Exam Pater Hane AB PYA SEATED Lower Extremity Physiologic Study Single Level Seated ABI Exam Delete Right Left Arm and Ankle Pressures Reference ABI Table 9 Merten c E Brachial Brachial 8 ear 120 124 zie mre hry mmHg PT PT Absnlute 1 70 1 85 Absolute immune bry mmHg Conectad 132 147 comosa Hydrostatic Correction mmHg mmHg Corm chad 1 06 Cull Height 1 18 Conmectad Indas Hil em Index Modality PRA 01 04 10 10 20 57 PRA 01 04 10
11. rolls K180 Gel Ultrasound Gel 250 g G155 Ultrasound Gel 60 g G150 Probes serial numbers required Bi Directional Probe 8 MHz for Vista product line SD8V Bi Directional Probe 5 MHz for Vista product line SD5V PPG Probe SPPG Battery Pack Battery Vista ABI 7 2 V B200 Rolling Cart Roll stand with Basket K270 Carrying Case 16 x 12 x 4 For the Vista ABI only not for the pole roll stand and basket K280 MANO024 DFU Rev A 5 13 41 Wallach Surgical Devices SECTION 15 Troubleshooting Guide Troubleshooting 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 Vista ABI contains no user serviceable components Only qualified personnel should attempt to service the unit CAUTION Do not drop or mishandle the Vista ABI probes Damage may occur Vista ABI Troubleshooting Guide Symptom Check for Doppler is not audible when user rubs Doppler mode is not selected see pg 14 for selecting modalities probe tip Mute is selected Probe cable is not plugged into the main unit or plugged into an incorrect part USB cable is connected to PC Cannot obtain PPG signal at toe TBI mode is not selected PPG PKG IS OPTIONAL Probe cable is not plugged into main unit Verify PPG signal can be obtained on a finger if yes try warming the foot Unit will not print Prin
12. site to listen to the blood flow While holding the probe steady on the artery press and hold the PUMP key to about 20 mmHg above the occlusion pressure Release the PUMP key and the cuff will automatically start to deflate MANO024 DFU Rev A 5 13 25 Wallach Surgical Devices Press the SAVE key when you hear the first pulsation return If you were late pressing the SAVE key you can adjust the pressure reading by using the UP or DOWN key You will then press the SAVE key again to record the systolic pressure and the marker will move to the next protocol location Move the hose from the arm cuff to the ankle cuff to obtain the ankle waveform using PVR Press and hold the PUMP key to inflate the cuff to 75 mmHg and release the key when the inflation automatically stops Pressure will deflate to 65 mmHg for optimum PVR Wait for the cuff deflating message on the display to disappear If needed use the SCALE key to optimize the waveform After the waveform stabilizes press the FREEZE key and if the waveform is acceptable press the SAVE key to record Or use the UP or DOWN key to scroll to the optimum waveform and press the SAVE key to record it Press the SAVE key again to move to the next protocol location Now obtain the ankle pressure The hose should be connected to the ankle cuff Apply gel to either the dorsalis pedis artery or the posterior tibia artery and use the Doppler probe to listen to the blood flow While holding the pr
13. the number 5 key to download the current exam Current patient data will be transferred automatically or press the ENTER MENU key to cancel See Section 17 for more information about the AVS Report software VISTA TIP e When downloading data the current exam screen is transferred to the PC e Downloading is only possible if the USB cable is connected between the Vista ABI and the PC e AVS Report software must be installed on the PC in order to transfer data Downloading Exam from File current exam has been saved To download patient data to a PC open the OPTIONS screen using the ENTER MENU key Press the number 3 key to select FILE MANAGEMENT Press the number 4 key to download an exam that has been previously saved Using the numeric keypad select the number of the file to recall and download Saved patient data will be transferred automatically or press the ENTER MENU key to cancel You may also download all of the saved exams at once by using the UP or DOWN arrow keys to select DOWNLOAD ALL and pressing the ENTER MENU key VISTA TIP e This mode is useful to help expedite downloads of saved files by eliminating the need to recall the file first MANO024 DFU Rev A 5 13 20 Wallach Surgical Devices SECTION 10 Peripheral Arterial Waveform Interpretation Bi Directional Waveform Interpretation Continuous wave bi directional Doppler waveforms are useful for assessment of lower extremity P A D severity and progressi
14. will be either the higher or the lower value depending on the user setting VISTA TIP e When conducting the ABI exam on an amputee use the SITE key to select the appropriate pressure waveform locations Left Ankle Waveform Repeat the procedure described previously for the right ankle waveform When the left ankle waveform is stored in the L WAV site the site cursor moves to L ANK left ankle pressure site Left Ankle Pressure Move the cuff hose to the left ankle cuff and repeat the procedure described for the right ankle on the left ankle When the left ankle pressure is stored in the L ANK site the site cursor moves to L BRA left brachial pressure site MANO024 DFU Rev A 5 13 2 Wallach Surgical Devices Left Brachial Pressure Move the cuff hose to the left arm cuff and repeat the procedure described for the right brachial on the left brachial The greater of the two arm pressures will be used to calculate the ABI A difference of 20 mmHg or more between the two brachial pressures is a possible indication of upper extremity stenosis In this case the arm pressures should be repeated and if the result still indicates a difference of 20 mmHg or more upper extremity testing should be considered After the left brachial pressure is stored in the L BRA site the site cursor moves to R BRA right brachial pressure site At this point the exam data 1s ready for saving printing and or downloading Assessment of the Ankle B
15. 10 220 h J i 1 i i eae e eee CCNSCAS EZA dh J MX i LA J U L H Y ia Me i Wy J n i ur uu p 3 i ae E as 22m au us EZ 5 5 l ai ET zu as MANO024 DFU Rev A 5 13 50 Wallach Surgical Devices Segmental Study Arm and Lower Extremity Index Values Modality CPT ICD 9 Codes CPT ICD 9 Codes Tab Lower Extermity Physiologic Study Multiple Level Segmental Exam Right Left Brachial 120 122 mantig mmHg 0613 00 12 1554 Thigh Arm and Lower Extremity 7 Pressures 120 1221 02 A e P 1 00 Index 0723 90 12 17 20 1 03 ladax EE a 0730 12 18 2 127 mml tg 1 04 leder 128 mantig 1 04 Index 100 mmHg 0 81 ledex A 126 mml ig 126 mmHg 1 03 Index Blo Knee 129 mmlig 1 05 Index 06 1348 122203 135 mmHg 1 10 Index 136 mmHg 1 11 ledex 06 13 08 12 24 3 105 mmHg 0 86 ledex amp 4 Time and Date The CPT and ICD 9 Codes Tab allows the user to select a billing option to be displayed on the report Select the tabs at the bottom of the page to choose either CPT or ICD 9 Select the appropriate code on each screen or type a code in the Other section if the desired code is not available Only one selection can be valid on any given report Patient Info Pressures Waveforms CPT ICD3 Codes CPT Codes C 93922 Non invasive physiologi
16. ANO024 DFU Rev A 5 13 43 Wallach Surgical Devices SECTION 17 AVS Report Report Generation Software NOTE If the software is not purchased with the Vista ABI model L450V A 5 trial downloads will be included so you can try it out prior to purchase The AVS Report software allows the clinician to download examination results from the Vista 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 AVS Report software should conform to recognized standards for safety such as IEC601 1 IEC60065 UL2601 1 or UL544 The Vista ABI shall not be connected to the user supplied external hardware during an examination The Vista ABI and AVS Report software shall be operated by trained personnel who have read all manufacturer supplied documentation The AVS Report software does not provide an interpretation of the examination results Results should be verified prior to performing additional procedures on the patient CAUTIONS Inthe event of AVS Report software transmission error the data is invalid and shall be re transmitted To ensure integrity of data on the user supplied external hardware the equipment should be backed up frequently To ensure proper operation of the user supplied external hardware the equipment should run virus checking software and system diagnostics frequently e Whe
17. AVSReport InstallShield Wizard Ready to Install the Program The wizard is ready to begin installation If you want B review or change any of your installation settings click Back Click Cancel to 3 S elect i Install to lo ad to the AV S Rep ort exit the wizard Current Settings software program to your computer Setup Type Typical Destination Folder C Program Files Summit DopplerAVSReportl User Information Name Neil D Company Summit Doppler MANO024 DFU Rev A 5 13 45 Wallach Surgical Devices i AVSReport InstallShield Wizard Installing A SReport The program Features you selected are being installed Please wait while the InstallShield Wizard installs AVSReport This may take several minutes 4 This screen will appear as the installation Status is in process BRRRRRRRRRRRRERAMN Cancel ts OCMMBDCUME TWEEH 1A TVLOCALS TATempleke ZHOTWDPInst Monsig axa l2 bit k detected 1 CURE IHEM JA LOCALS i Tempe ke PSDP ne tite exe netalling driver 5 This screen will be displayed briefly just before the Installshield Wizard is complete ie AVSReport InstallShield Wizard InstallShield Wizard Completed The InstallShield Wizard has successfully installed AvSReport 6 When this screen appear S the AVS Report Click Finish to exit the wizard software has been successfully installed Select Finish to complete the installation process Conn
18. Ankle Waveform Verify that the protocol marker is on R WAV VISTA TIP e Asingle level lower extremity arterial examination normally consists of the ABI value and either bi directional Doppler waveforms or PVR waveforms The following shows how to set the waveform mode See Section 10 for information on waveform interpretation Note that arterial tests documented with PPG waveforms are not reimbursable as opposed to Doppler or PVR waveforms The Vista ABI can acquire bi directional Doppler waveforms pulse volume recording PVR waveforms and photoplethysmography PPG waveforms if the PPG probe is purchased separately with the PPG Package See Section 5 for configuring the desired waveform mode OBTAINING DOPPLER WAVEFORMS Apply a small amount of coupling gel over the site of the artery either the PT or DP artery Place the probe over the artery at an angle of approximately 45 degrees pointing the probe tip in the direction toward the calf and knee Slide the probe slowly across the artery until the best signal 1s obtained Once the waveform is optimized press the SCALE button one or more times as needed to adjust the vertical scaling to obtain a waveform as large as possible without clipping at the top If the probe is pointed in the correct direction approximately 45 degrees upstream the majority of the waveform will be above the baseline Press PRINT to print the waveform or FREEZE to freeze or pause the waveform When frozen
19. R Waveform 2 ABI with Doppler Waveform 3 TBI with PVR Waveform 4 TBI with Doppler Waveform NOTE Options 5 and 6 are not 5 Segmental with PVR Waveform available for use with the Vista 6 Segmental with Doppler Waveform ABI system MANO024 DFU Rev A 5 13 1 Wallach Surgical Devices VISTA TIP e The current configuration mode will be displayed at the bottom of the waveform upon returning to the main screen Setting the Date and Time EN Press ENTER MENU to open the OPTIONS menu 2 Press the number 2 key to select SYSTEM SETTINGS 3 Press the number 1 key to set the clock 4 The clock setting format is MM DD YY HH MM SS Month Day Year Hours Minutes Seconds 5 Use the UP key to move the cursor over the field that needs to be changed 6 Use the numerals on the hand held controller to set the date and time 7 Press ENTER MENU or move the cursor to the end to exit the CLOCK menu 8 Press the ENTER MENU key to exit the OPTIONS menu Contrast Adjust To modify the contrast level on the Vista ABI screen 1 Press the ENTER MENU key to open the menu 2 Press the number 2 key to select the SYSTEM SETTINGS 3 Press the number 2 key to increase CONTRAST ADJUST LEVEL one level 4 Continue to press the number 2 key until desired level is reached VISTA TIP e If there is flickering or shadowing on the text the contrast is adjusted too high Readjust contrast level by pressing the number 2 key
20. SummitDpppler a WALLACH eal i brand User Manual for Vista ABI L450VA with Stand and Basket L450VANS Stand and Basket not included WALACH SURGICAL DEVICES C oos6 MANO0024 DFU Rev A 5 13 Wallach Surgical Devices TABLE OF CONTENTS Vista ABI Section ilit 1 Section 2 Safety DI foEnidtloli wesevsceccsscscieeeniscevecscesvensaiececcnccssseneaiancsnesceseesesaeecdecesese 2 Section 3 Description of Product and Controls eere 5 Section d Preparation for US ciceccccsscecicdeccessecesetescdsvecsscccsceeicdevetssedeseteredevecssecceoess 9 Section 5 Menu Configuration and Set Up c ceeeee ecce eese eee eee eene nue 11 Section 6 The Ankle Brachial Index ABI Examination 16 Section 7 The Toe Brachial Index TBI Examination 23 Section 8 The Seated ABI Examination eere eee eee ee eee eee eee e aeos ss ssaus 25 pection 9 File Management eei eese ione oae o coco c s rep iaa Depos coord soa deu eoe 21 Section 10 Peripheral Arterial Waveform Interpretation 30 Section 11 Maintenance and Cleaning eee ee rece eee ee eee eee eene e eene enn onne 33 Section 12 Battery Recharging and Replacement eee 35 Secuon LS SpDOCHICAU S es cyseccsccgcveseess eS eene Perd neeee et
21. Supply Voltage 100 240 VAC 50 60 Hz 1 2 A Output 7 V 5A Battery Type 6 cell NiMH pack Rating 7 2 V 2000 mAH Replacement Part No B200 Battery Life 3 hours continuous use or minimum of 12 ABI Exams Replacement Interval year Charge Time 3 hours Mechanical and Environmental Dimensions 10 Hx 12 W x 3 6 D Weight 4 75 lbs Stand height 47 Operating Conditions Temp 10 to 30 C Humidity 30 to 75 non condensing Transport amp Storage Conditions Temp 20 to 50 C Humidity 5 to 90 non condensing Safety Degree of protection against electric shock Type B Applied part Classification u Class II Equipment when externally connected Internally Powered Equipment when not externally connected battery powered Degree of protection against ingress of water Ordinary not rated Designed and tested to meet IECO601 1 IEC60601 1 2 IEC60601 1 4 IEC60601 2 37 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 Vista ABI and the source of the interference WARNING Connect the Vista ABI only to equipment that meets the appropriate standards The Vista ABI and its External Power Supply are a medical system The External Power Supply must meet IEC60601 1 construction requirements for Reinforced Insulation at minimum in order fo
22. a Phillips head screwdriver to attach the Vista ABI mounting bracket to the end of the rolling stand s pole Be sure to fit the pole s alignment pin through the alignment hole on the bracket 5 Use the two stand mounting knobs to attach the mounting bracket to the Vista ABI 6 Review the unit and locate each of the controls and connectors see Section 3 and information on the next page 7 Plug the external power supply into the 7 VDC Power connector VISTA TIP For first time use allow the unit to charge for at least one hour before operating the Vista ABI from its battery MANO024 DFU Rev A 5 13 9 Wallach Surgical Devices 8 Plug the power cord into the external power supply and then into a properly grounded wall outlet 9 Plug the Doppler cable into the Doppler probe 10 Plug the Doppler cable into the Doppler connector Blue port 11 Plug the PPG probe if applicable into the PPG connector Black port VISTA TIP e The Doppler and PPG connectors are color coded and physically interchangeable If you fail to connect the proper probe no damage will occur 12 Attach a cuff to the Luer style hose fitting 13 Plug the hose quick connect style fitting into the CUFF connector on the connector panel 14 Plug the hand held controller into the HAND CONTROLLER connector VISTA TIP To maintain patient safety it is not possible to conduct an examination while the Vista ABI is connected to a PC vi
23. a the USB port Connectors 5 Doppler PPG Hand USB 7VDC Power Cuff Controller MANO024 DFU Rev A 5 13 10 Wallach Surgical Devices SECTION 5 Menu Configuration and Set Up Loading Paper The Vista ABl 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 paper door and push firmly enough to latch the door into position Press the FEED button to ensure proper paper alignment i o SS 4 192952 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 switch to begin using the instrument Configuring the Examination The Vista ABl can be configured to perform P A D testing in four different automated modes Pressure can be obtained using either the Doppler at the ankle for typical ABI testing described in Section 6 or using a PPG at the toes for TBI testing described in Section 7 Additionally waveforms used to complete the physiologic study can be performed with either a Doppler or the Pulse Volume Recording PVR mode 1 Press the ENTER MENU key to open the OPTIONS menu 2 Press the number 1 key to select the CONFIGURE EXAMINATION 3 Select the desired configuration for the examination by pressing the appropriate number 1 ABI with PV
24. am Date 01 04 10 10 29 50 eae ae E L Intermittent Claudication Location LJ Diabetes XX Hyperlipidemia L Numbness Tingling in Feet Buttocks gt 1 3 Non compressible C Heart Disease L Stroke TIA Ulcerations C Thigh 1 0 1 29 Normal Previous CV Event Li Prev Vascular Surgery DX Rest Pain L Calf 10 91 0 99 Borderline High blood cholesterol L Gangrene L Feet 10 41 0 90 Moderate to Mild Pain when resting at home 10 00 0 40 Severe interpreting Physician Dr Jones Referring Physician Dr Smith Comments Patient unable to get onto bed for exam Use seated position for exam Tobacco Use L Hypertension Risk Factors Current Symptoms ABI Severity of Disease RIGHT _ LEFT Brachial gt Brachial 120 124 mmHg mmHg PT Fl PT Absolute 170 N i SOY 185 Absolute mmHg A mmHg Corrected 1 32 j 1 47 Corrected mmHg morn dd mmHg Corrected 1 06 1 1 8 Corrected Index Cuff Height 50 cm 01 04 40 10 28 57 PVRX4 01 0440 10 29 38 interpretation No PAD present CPT Code 93922 Non invasive physiologic studies of upper or lower extremity arteries single level bilateral ICD 9 Code 440 22 Atherosclerosis of native arteries of the extremities with rest pain MANO024 DFU Rev A 5 13 57 Wallach Surgical Devices Completed Sample Segmental Study Report in PDF File Format Lower Extr
25. atient Name Date of Birth e Patient Name Date of Birth Age Sex I D Number Date Time Age Mr John Smith 03 10 1940 m Mw 1234567690 11 09 10 14 52 29 _ Interpreting Physician Referring Physician N b Dr Fred Jones DrJoe Smith WU INUMDECT Date Time m Interpreting Physician p Interpreting Physician Referrin g Physici an Urn Assigned n Assigned Or Joe Smith Or Fred Jones MANO024 DFU Rev A 5 13 48 Wallach Surgical Devices Patient Name or Patient ID will be downloaded directly from the Vista ABI file information if it was saved on the device Risk Factors Risk Factors Check the appropriate boxes to enter the M Tobacco Use Hypertension patient s P A D risk factors The Other E z Boas section can be used for extra details such M Previous CV Event Previous Vascular Surgery as pack years of smoking or date of Other previous CV event T Current symptoms Current Symptoms Intermittent Claudicatian Location Check appropriate boxes to enter the Numbness tingling in feet M Buttocks patient s P A D symptoms and the ELI E Rest Pain Calf location of the symptoms The Other Wo Feet section can be used for extra details such Other as when or how often symptoms occur Comments Examiner Comments Interpretation General comments and interpretation sections are provided for extended comments from the interpreting clinician
26. ation by Sphygmomanometry 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 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 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 M
27. ble with mute MANO024 DFU Rev A 5 13 37 Wallach Surgical Devices Photoplethysmography PPG Optional feature Wavelength 940 nm Artifact Rejection Synchronous demodulation AC coupled output Operating Frequency 1 kHz Cable length 6 5 ft Pressure Range 0 265 mmHg Accuracy 0 200 mmHg 3 mmHg above 200mmHg 2 Safety Pressure released if greater than 280 mmHg Pressure released if held above 100 mmHg beyond 3 minutes Pressure released if held between 30 100 mmHg beyond 5 minutes Operator may over ride for exam purposes Redundant Control Bleed Rate 2 5 mmHg sec nominal PVR 0 16 to 12 5 Hz bandwidth AC Coupled Display Size 5 7 V4 VGA 320 x 240 dot Backlight LED Backlight Type Transflective Monochrome Printer Type High Speed Thermal Array Paper Width 58 mm Print Width 48 mm Resolution 8 dots mm Paper Type Thermal Product Number K 180 Adhesive Backed Label or Thermal Archival 58 mm CAUTION e Use only the specified paper supplied by Wallach Surgical Devices Use of improper paper may damage the print mechanism Data Storage and Transfer Storage 10 storage locations 16 numeric or 24 alpha character length filenames Type USB 2 0 Connector Peripheral Output Optional AVS Report Software model L450SF Adobe PDF or comma delimited files MANO024 DFU Rev A 5 13 38 Wallach Surgical Devices Power External Suppl Type Medical Grade Supply Rated Mains
28. bout 20 mmHg above the occlusion pressure After the pump stops the Vista ABI automatically bleeds the cuff at the correct rate Press the SAVE key at the moment flow returns This will store the brachial pressure value in the R BRA protocol location This is the systolic pressure In general the audible Doppler signal is a slightly more sensitive indicator of the systolic pressure than the Doppler waveform display MANO024 DFU Rev A 5 13 17 Wallach Surgical Devices FROZEM Doppler Waveform During Acquisition of Systolic Pressure Je SAVE ir Pressure or enter Press on EE ee ee a ee The cuff deflates automatically when SAVE is pressed If needed press PUMP again to repeat the measurement or use the arrow keys or numeric keypad to adjust the pressure value before confirming the value by pressing the SAVE or SITE key Press SITE or SAVE again to confirm the right brachial pressure and move to the next protocol location VISTA TIP Once a satisfactory pressure has been obtained pressing SAVE or SITE will confirm the stored value and move to the next protocol location e During deflation pressing PUMP again will re inflate the cuff and allow a new pressure to be taken OBTAINING PRESSURES USING THE PPG PROBE Please note the PPG probe is sold separately which includes a digit cuff for obtaining toe pressures In the supine position ABI pressures can also be obtained using the PPG probe For obtaining pre
29. c studies of upper or lower extremity arteries single level bilateral C 93923 Non invasive physiologic studies of upper or lower extremity arteries multiple level bilateral No CPT Code Other ICD 9 Codes N E EJ 2S E E XN X E 250 70 Diabetes Mellitus with Peripheral Circulatory Disorders Type Il or unspecified type not stated as uncontrolled 250 71 Diabetes Mellitus with Peripheral Circulatory Disorders Type not stated as uncontrolled 250 72 Diabetes Mellitus with Peripheral Circulatory Disorders Type Il or unspecified type uncontrolled 250 73 Diabetes Mellitus with Peripheral Circulatory Disorders Type uncontrolled 440 20 Atherosclerosis of native arteries of the extremities unspecified 440 21 Atherosclerosis of native arteries of the extremities with intermittent claudication 440 22 Atherosclerosis of native arteries of the extremities with rest pain 440 23 Atherosclerosis of native arteries of the extremities with ulceration 440 24 Atherosclerosis of native arteries of the extremities with gangrene 440 23 Atherosclerosis of native arteries of the extremities other 440 30 Atherosclerosis of bypass graft of the extremities 440 32 Atherosclerosis of nonautologous bilogical bypass graft of the extremities AA RS OE AREE EXE 443 89 Other specified peripheral vascular diseases 443 90 Peripheral vascular disease unspecified 707 06 Decubitus Ulcer Ankle 707 07 Decubitus Ulcer Heel 707 10 Ulcer of lower limb
30. cians prefer to leave the patient s socks on until they are ready to take the toe pressures Brachial Pressures Brachial pressures are conducted in the manner described in Section 6 for the ABI examination Ankle Waveforms Either Doppler or PVR waveforms may be used accurately on patients with noncompressible arteries In some cases calcification may result in reduced ultrasound penetration and weak Doppler signals Refer to Section 5 for details on switching to Doppler or PVR waveforms Obtaining ankle waveforms is described in Section 6 Toe Pressures Refer to Section 5 for details on configuring the system for TBI using PPG Wrap the great toe with a 2 5 cm or 1 9 cm digit cuff and attach the pressure hose The cuff should be 40 of the toe circumference Place the cuff at the base of the toe and attach the PPG probe to the distal phalanx with the blue side of the probe against the skin as shown in the photos below NOTE The ankle cuff is not used while taking toe pressures MANO024 DFU Rev A 5 13 23 Wallach Surgical Devices Wait a few seconds for the PPG waveform to stabilize after applying the probe Once a stable PPG waveform is obtained press the PUMP key to inflate the digit cuff Continue to inflate to a pressure approximately 20 mmHg above the pressure where the PPG pulsations disappear The digit cuff will begin to deflate automatically once the pump stops To get a better view of the waveform on the display press
31. click OR physician names to be used for referring or interpreting physician on the patient information tab Select Add to enter a new name MANO024 DFU Rev A 5 13 53 Wallach Surgical Devices ABI Severity nf Disease 1 3Non comprestibie 70 hormal TO 123 OF 0 70 Borderie qom 0 060 Borderina QUOD Qu64 Abnormal 1G 0 00 Medermin jo bit auno 0 40 berera ABI Severity of Disease 1 3 Non compressible 1 0 1 28 Normal 0 91 0 99 Borderline 0 41 0 90 Moderate to Mild 0 00 0 40 Severe To edit text line Double click text line to edit the text To delete text line Right click text line and select Delete Ta add a new line Click on New Line box below Left click and drag to new location Edit Text Exporting a Report This screen allows a user to customize the severity table shown in the report The default is from the ACC AHA guidelines To customize select Custom To edit the text line double click the text line To delete the text line right click the text line and select Delete To add a new line click on New Line left click and drag to a new location Press OK when finished editing a line af tevt This screen will appear next Click OK when complete There are three file export types that are supported Adobe PDF DICOM and Comma Delimited files csv NOTE The saved files will default directly into the folder init
32. d with PPG meet reimbursement criteria if accompanied by either Doppler or PVR waveforms For these reasons Wallach Surgical Devices recommends using PVR and Doppler modes for waveform analysis MANO024 DFU Rev A 5 13 32 Wallach Surgical Devices SECTION 11 Maintenance and Cleaning Cleaning Precautions WARNINGS The Vista ABI is not designed for liquid immersion Do not soak or drop the probes or main unit in liquids Do not use solvent cleaners Do not use products containing bleach Use only the recommended spray or wipe cleaners and disinfectants see Cleaning and Disinfection below The Vista ABl is not designed for sterilization processes such as autoclaving irradiation or hydrogen gas The Vista ABI is not intended for use on open skin If there is evidence of open wound contamination disinfect the probes before using again as described below Cleaning and Disinfection Excess gel should be wiped off the ultrasound probes after every examination Probes and main unit should be cleaned with a cloth dampened with 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 speaker grill 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 1s the only disinfectant t
33. e The PRINT key prints the patient data in the exam screen Use the RECALL function described above to recall a saved file 1f needed When only one waveform has been saved the saved pressures ABIs and one waveform will print If no waveform has been saved only the pressures and ABIs will print The printout will show 4 seconds of recorded waveform data although the display only shows 3 seconds NOTE It is not possible to print directly from the FILE menu MANO024 DFU Rev A 5 13 28 Wallach Surgical Devices Deleting a File To delete an exam press the ENTER MENU key to open the OPTIONS screen Press the number 3 key to select FILE MANAGEMENT Press the number 2 key to delete an exam from a file storage location Select the file number on the numeric keypad to delete the file which will be highlighted Press that number again to confirm or press any other key to cancel To return to the exam screen press the ENTER MENU key to exit To delete all files use the UP or DOWN keys to navigate to DELETE ALL and press ENTER MENU Press the ENTER MENU key again to confirm deletion or press any other key to cancel Downloading a File to a PC current exam has NOT been saved Please note that the AVS Report software model LASOSF sold separately is needed to download files to a personal computer PC To download patient data to a PC open the OPTIONS screen using the ENTER MENU key Press the number 3 key to select FILE MANAGEMENT Press
34. e Mountain Drive 150 Golden CO 80403 Phone 303 423 7572 Fax 303 940 7165 Toll Free 800 554 5090 Examiner Kathy C RVT Modality Pressures Doppler MANO024 DFU Rev A 5 13 50 Wallach Surgical Devices SECTION 18 Warranty The Vista ABI is warranted against defects in material and workmanship for 12 months from the original sale of the device Product life 1s 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 on return shipments to Wallach Surgical Devices improper maintenance or cleaning as d
35. e Vista ABI Doppler probes were designed to be safe and effective However the risk from some hazards cannot be eliminated completely Instead they are reduced to a level that is As Low As Reasonably Achievable ALARA Prudent use of this device in accordance with the principle of ALARA includes minimizing the duration of the patient s exposure to ultrasound to the extent practical Clinical Safety Approved by the American Institute of Ultrasound March 1997 October 1982 Diagnostic ultrasound has been in use since the late 1950s Given its known benefits and recognized efficacy for medical diagnosis including use during human pregnancy the American Institute of Ultrasound in Medicine herein addresses the clinical safety of such use There are no confirmed biological effects on patients or instrument operators caused by exposures from present diagnostic ultrasound instruments Although the possibility exists that such biological effects may be identified in the future current data indicates that the benefits to patients of the prudent use of diagnostic ultrasound outweigh the risks if any that may be present MANO024 DFU Rev A 5 13 3 Wallach Surgical Devices Safety in Training and Research Approved by the American Institute of Ultrasound March 1997 March 1983 Diagnostic ultrasound has been in use since the late 1950s There are no confirmed adverse biological effects on patients resulting from this usage Although no hazard ha
36. e the power is turned off NOTE Powering off by unplugging the system will not activate this feature MANO024 DFU Rev A 5 13 21 Wallach Surgical Devices Recalling a File To recall an exam press the ENTER MENU key to open the OPTIONS screen Press the number 3 key to select FILE MANAGEMENT Press the number 3 key to recall an exam from a file storage location Select the number of the file to be recalled using the numeric keypad To return to the existing file without recalling one of the saved files press the ENTER MENU key to exit FILE MANAGEMENT The Vista ABI automatically stores a backup copy of patient data in the Restore Data each time a new name pressure or waveform is saved The exam stored in the Restore Data is purged upon entering patient data name pressure or waveform for a new exam In other words once new patient data is entered for a new exam the previous exam in the Restore Data is deleted and the new exam is stored in the Restore Data Itis important to note that the power down and clear exam functions do not erase the previously stored exam in the Restore Data To access the exam stored in the Restore Data press the ENTER MENU key to open the OPTIONS screen Press the number 3 key to open FILE MANAGEMENT and press the number 3 key again to open RECALL EXAM FROM FILE Next press the UP key to highlight RESTORE DATA and press the ENTER MENU key to open the exam RECRLL Printing a Fil
37. ecting to Vista ABI Using the USB cable provided connect the equipment end of the cable to the Vista ABI and the computer end of the cable to an unused USB Port on the PC Once the cable is connected to both devices turn on the Vista ABI When the computer successfully recognizes the device the following message will appear Found New Hardware USB Serial Converter MANO024 DFU Rev A 5 13 46 Wallach Surgical Devices Starting AVS 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 Generating a Report USB Communication When the Vista ABI is on and connected to the computer while the AVS Report software is running the bottom of the screen will indicate Connected The Read Success indicates that the communication channel is open and operating properly 12 26 2006 1 35 PM Connected Head Success If the indication 1s Disconnected then the software was started without the Vista ABI connected PLEASE NOTE The software can be operated without the device connected for opening previously generated files printing or importing as described below 12 26 2006 1 37 PM Disconnected If the indication is Write Call Failed then the AVS Report has lost communication with the Vista ABI Check to ensure the cables are connected at both ends and ensure the unit is on 12 26 2006 1 36 PM Wie Call Failed
38. ed 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 Dicrotic notch is missing bows away from the baseline XB Cu Lt Cr zx ab a E E t3 a m k Location 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 Hb in the ACC AHA P A D Guidelines Hirsch 2005 NOTE Although Doppler waveforms are given a higher recommendation than PYR waveforms PVR waveforms may be easier to obtain PPG Waveforms By using the optional PPG probe PPG waveforms are made available on the Vista ABI PPG waveforms are similar to the interpretation of PVR waveforms However because the PPG waveform is obtained at a digit distortion of the PPG contour due to vasoconstriction or vasodilation is more common PPG waveforms are not acceptable for meeting reimbursement criteria for the lower extremity arterial exam however PPG 1s useful for obtaining pressures as described in Section 7 Toe pressures obtaine
39. emity Physiologic Study Multiple Level Segmental Exam Patient Name Richard Smith Patient DOB 02 31 1948 Risk Factors DX Tobacco Use 2 Diabetes Heart Disease C Previous CV Event 3 Pack per Day Smoker Diabetes not well controlled Patient Sex ut Hypertension L Hyperlipidemia L Stroke TIA Prev Vascular Surgery donum p Vascular Facility 123 Main St Ft Collins CO 80655 Patient ID 1233356 Age 78 Exam Date 06 13 08 12 54 39 Current Symptoms intermittent Claudication Numbness Tingling in Feet BY Ulcerations i Rest Pain Gangrene 1cm non healing wound on calf Location L Buttocks L Thigh lt Calf 1 0 1 interpreting Physician Dr Baum Comments Exam performed by Sheila Smith RIGHT Brachial 120 Thigh 123 mmHg i Er 1 e oy a T 1 i index 06 1 208 12 25 37 Abv Knee 126 mmHg J 4 05 Index Calf 129 mmHg 1 07 Index PT 132 mmHg 1 10 index Toe 98 mmHg 0 81 Index Sernin interpretation no PAD CPT Code MAN0024 DFU Rev A 5 13 Referring Physician Patient has normal waveform and pressure 58 Brachial Dr Rich ABI Severity of Disease index for Ankies Only gt 1 3 Non compressible 29 Normal Feet 0 91 0 99 Borderline 0 41 0 20 Moderate to Mild 0 00 0 40 Severe LEFT 951308 de
40. eport Software Digit Cuff MANO024 DFU Rev A 5 13 1 Wallach Surgical Devices SECTION 2 Safety Information Intended Use This device is intended for detection of blood flow in veins and arteries and as an aid for the diagnosis of peripheral vascular disease Contraindications WARNINGS The ultrasound probes are not to be used on or near the eyes This device is for use only on intact skin This device is not intended for use with HF surgical equipment This device 1s not intended for fetal use General Warnings WARNINGS The Vista ABl is for use by qualified personnel only Read the User Manual before use Carefully route all cables and tubing to reduce the possibility of patient entanglement or strangulation Do not allow the patient to operate any portion of the equipment including the hand held controller Do not place the equipment in any position that would allow it to roll fall or collide with the user or patient 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 Do not connect Luer fittings from Summit Doppler equipment into any other equipment Confirm the setting of the real time clock prior to saving patient data Any equipment connected to the USB data port must be configured to comply with IEC 60601 1 By connecting additional equipment to the USB data port the user is
41. escribed 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 Vista 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 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 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 MANO024 DFU Rev A 5 13 60 Wallach Surgical Devices SECTION 19 Explanation of Symbols 4 q 4 Reorder Number Keep Dry o serial Number 4 Type B Applied Part Ici Class II Equipment ATTENTION See instructions for use Manufacturer Date of Manufacture Symbol indicates that the device should be sent to the special agencies according to local regulations for separate collection after its useful life e Latex Free A ud A C Coos6 Product conforms to the Medical Device Directive 93 42 EEC Ec nee Authorized Representative in the European Communi
42. g for the effects of gravity on the lower extremity pressures based on the vertical distance between the arm and ankle cuffs To begin the exam have the patient sit erect in a chair with knees at a 90 degree angle The feet should rest flat on the floor or on an elevated platform feet should not be dangling Wrap the cuffs around the arms and ankles To determine the difference in height between the two cuffs using a tape measure or yardstick measure the distance in centimeters between the middle of the arm cuff to the floor and the middle of the ankle cuff to the floor as shown below Next subtract the ankle distance from the arm distance to get the vertical distance to be entered for the hydrostatic correction Press the ENTER MENU key on the hand held controller to open the OPTIONS menu Press the number 1 key to CONFIGURE EXAMINATION You will press the number 1 key to select ABI with PVR Waveform Press the ENTER MENU key to open the OPTIONS menu again and press number 2 key for SYSTEM SETTINGS Press the number 6 key to use the Doppler probe for obtaining pressures Press the ENTER MENU key to exit Press the ENTER MENU key again to open the OPTIONS menu You will then press the number 7 key for HY DROSTATIC CORRECTION and using the keypad enter the vertical height between the cuffs in centimeters Press the SAVE key when finished Start at the right brachial by applying the gel and placing the Doppler probe over the artery
43. ght Right Ankle Pressure Verify that the protocol marker is on the R ANK location VISTA TIP e The system can be configured for exam protocols that use either one or two DP and PT ankle pressure measurements See Section 5 for information on how to set the Ankle Protocol Ensure that the pressure hose is connected to the fitting on the right ankle cuff Position the Doppler probe over the PT or DP artery Be sure to use ample gel Obtain an adequate signal then press and hold the PUMP key to inflate the cuff Release the key once the pressure reaches about 20 mmHg above the occlusion pressure After releasing the PUMP key the Vista ABI automatically deflates or bleeds the cuff at the correct rate Press the SAVE key at the moment flow returns to store ankle pressure value in the R ANK location MANO024 DFU Rev A 5 13 20 Wallach Surgical Devices The cuff fully deflates automatically when the pressure is saved If needed press PUMP again to repeat the measurement or use the UP or DOWN keys or numeric keypad to adjust the pressure value before confirming the value by pressing the SAVE or SITE key Protocol for Two Ankle Pressures If the protocol configuration is set to HIGH or LOW press SAVE while deflating to the PT pressure Press SAVE again to confirm this pressure 03 04 2010 09 1 The site will change to DP Press PUMP to repeat the pressure cycle Both pressures will be stored and displayed The displayed ABI
44. hat is Wallach Surgical Devices approved for use with the Vista products Follow the instructions provided with the disinfectant and be sure to wipe the unit dry when finished Vista ABI users should wash hands and change gloves after every exam Refer to local and hospital policies regarding cleaning and disinfection Store the unit in a clean area free of dust and debris Follow the temperature and humidity storage requirements as specified in Section 13 Maintenance CAUTION e If the unit 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 1s noticeably diminished A qualified technician must verify the accuracy of the pressure readout annually Return the unit to Wallach Surgical Devices for calibration if needed See Section 13 for applicable pressure specifications MANO024 DFU Rev A 5 13 33 Wallach Surgical Devices Periodically not less than annually inspect the main unit and probes for signs of cracks or breakage Inspect cables tubing and connectors for signs of wear or failure Inspect labels for damage The user should discontinue use of the unit or probes if any loss of housing integrity is detected Check the tightness of the screw that attaches the mounting bracket to the rolling stand s pole 1f applicable at least annually protect human health and utilize natural resources prudently and rationally do
45. ially created in the File Path menu to store the AVS Report software mim Preferences Windows About Open waveforms CPT ICD9 Codes Save Close Save as Export Print Print Preview Printer Select Exit MAN0024 DFU Rev A 5 13 Adobe Acrobat pdr Comma Delimited csv d X Export and Launch Acrobat Export Report File Only Wallach Surgical Devices Adobe PDE 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 Export Report File Only to save store the file to view at a later time Enter a file name and save it to convert the current file to this format and the Adobe application if it 1s currently loaded on the PC will automatically start If the application is not loaded a free reader version can be downloaded from the website www adobe com Once the file has been converted and opened into the Adobe application all features and functions of that application are supported The file can be saved printed e mailed etc Comma Delimited Files Select File Export 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 automatical
46. layed waveform Frozen waveform Starts new waveform acquisition Moves the protocol marker to the next location Saves data before leaving old protocol location Changes the waveform scaling o O O 9 O O O O O SummitDeppler Wallach Surgical Devices MUTE Enables disables Doppler speaker output MUTE PRINT Prints out the waveform on adhesive backed label paper PRINT ENTER MENU Enters the displayed value or makes a menu Selection ENTER MENU Also used to open the OPTIONS screen UP Navigates through the menu in the up direction amp Moves the caliper tool to adjust the pressure values DOWN Navigates through the menu in the down direction amp Moves the caliper tool to adjust the pressure values Numeral Mode Character Mode Numeral 1 Numeral 2 A B C Numeral 3 D E F Numeral 4 G H I Numeral 5 J K L Numeral 6 M N O Numeral 7 P Q R Numeral 8 S T U Numeral 9 V W X Numeral 0 XA Space Space SPACE Hyphen Hyphen See Section 5 for information on how to change between character and numeral modes MAN0024 DFU Rev A 5 13 8 Wallach Surgical Devices SECTION 4 Preparation for Use Tools required Phillips head screwdriver 1 Unpack the Vista ABI and inspect the unit for external damage 2 Verify that you have received each of the contents listed on the packing list 3 Assemble the rolling stand if applicable using the instructions provided 4 Use
47. llach Surgical Devices SECTION 6 The Ankle Brachial Index ABI Examination Preparing the Patient In a warm room have the patient take off his her shoes and socks and rest in a supine position for approximately 5 minutes prior to taking pressures The patient should wear thin loose fitting clothing Avoid rolling up sleeves or pant cuffs in such a manner that it obstructs blood flow Bulky items such as sweaters should be removed Wrap the cuffs snuggly around the arms and ankles as shown below The edge of the cuff should be placed approximately 1 to 2 inches above the site of examination Select the proper cuff width equivalent to 40 of the patient s limb circumference In general average sized adults use 10 cm cuffs while larger adults use 12 cm cuffs The most efficient way to conduct the exam is to wrap all four limbs prior to taking any pressures 3 Arm Cuff Leg 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 very important that the patient remain still and in a supine position for the duration of the exam VISTA TIP The Vista ABI performs the ABI exam in the following order Right Brachial Pressure R BRA Right Ankle Waveform R WAV Right Ankle Pressure R ANK Left Ankle Waveform L WAV Left Ankle Pressure L ANK and Left Brachial Pressure L BRA You may override this order by using the SITE key to move between protoc
48. ly 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 DICOM Digital Imaging and Communications in Medicine Select File gt Export gt DICOM dcm Enter a file name and save it to convert the current file to a DICOM format that can be connected to a DICOM system 1 e PACS A DICOM viewer must be used to open and review these files AVS Report DICOM Conformance Statement The DICOM portions of the AVS Report application were developed using software tools supplied by Lead Technologies Inc a leading supplier of industrial medical imaging applications DICOM files created by AVS Report use the Secondary Capture Image Storage SOP Class These files have been evaluated using the conformance test supplied by Lead Technologies and meet all applicable criteria of this SOP Class Additionally AVS Report files have been successfully evaluated using several independent DICOM viewing applications As these standards are constantly evolving all efforts have been made to verify the DICOM files and data elements conform to the latest published DICOM standards for this SOP Class MANO024 DFU Rev A 5 13 55 Wallach Surgical Devices Completed Sample ABI Report in PDF File Format Lower Extremity Physiologic Study XYZ Diagnostics Inc Single Level ABI Exam 225 Wireless Blvd Anywhere NY 11788 Patient Name Mary Johnson 1 888 95 TESTS Patien
49. n the AVS Report application is running the Windows Standby and Hibernate functions are disabled 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 MANO024 DFU Rev A 5 13 44 Wallach Surgical Devices Installation instructions Insert the AVS Report installing disk into the CD ROM Drive Installation will start automatically and the following screen will appear NOTE The standard installation does not include DICOM formatted file option If you need the DICOM feature contact Wallach Surgical Devices to obtain the new software disk at 203 799 2000 or 1 800 243 2465 To install the DICOM feature contact Wallach Surgical Devices AVSReport InstallShield Wizard in Preparing to Install AVSReport Setup is preparing the InstallShield Wizard which 1 When you begin to install the AVS will quide you through the program setup process Please Report software this screen will appear wait Extracting 4 SReport msi Cancel 13 AVSReport InstallShield Wizard Welcome to the InstallShield Wizard for AVMSReport The InstallShield R Wizard will install AVSReport on your 2 Select Next to continue the installation computer To continue click Next WARNING This program is protected by copyright law and international treaties i ie
50. nduct fast efficient ABI examinations including display printer Doppler probe pressure hose and limb pressure cuffs The instrument operates from either its internal battery pack or from an external medical grade power supply at 100 240 VAC Controls and Indicators Main Unit ON OFF Turns the unit on or off with momentary actuation ec FEED Printer feeds paper while pressed c CHARGING CHARGING On Charging Flashing Charging complete trickle charging while flashing c VW BA LOW BATT Flashing Low battery PAPER RELEASE Blue button under paper dispenser Opens printer cover MAN0024 DFU Rev A 5 13 6 Wallach Surgical Devices Display Screen Protocol Location and Markers Hand Held Controller PUMP PUMP SAVE SAVE FREEZE FREEZE SITE SITE SCALE SCALE MANDO024 DFU Rev A 5 13 Right amp Left ABI Date and Time Pressure Gauge mmHg Right amp Left Brachial Sites Waveform Sites Right amp Left PT or DP _ 4 4 Right amp Left Ankle Sites PT or DP Toe Sites when in PPG Mode SS o Step By Step ABI Instructions Pump runs while pressed During deflation Stores current cuff pressure and deflates Active waveform Stores waveform data Frozen waveform Stores the frozen waveform 2 button press Confirms the stored pressure or waveform Active waveform Freezes the disp
51. not dispose of waste electrical or electronic equipment WEEE as unsorted municipal waste Contact local WEEE disposal sites WO In order to preserve protect and improve the quality of the environment MANO024 DFU Rev A 5 13 34 Wallach Surgical Devices SECTION 12 Battery Recharging and Replacement The external power supply Product Number B200 becomes the power source when the Vista ABI is operated while the supply is connected When the external power supply is connected while Vista 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 trickle charge The CHARGING indicator will turn off when charging is complete The Vista ABI uses a 7 2 V six cell Nickel Metal Hydride NiMH battery pack This battery pack has sufficient capacity to allow the product to be used for 12 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 1s 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 Vista ABI will not print when the battery is low to ensu
52. not incinerate MANO024 DFU Rev A 5 13 36 Wallach Surgical Devices SECTION 13 Specifications Note Unless otherwise indicated all specifications are subject to change without notice System Functionality Ankle Brachial Index e Ankle and Arm Systolic Pressures e Automatic ABI Calculation e Automatic Selection of Arm Pressure higher of the two e Configurable for one or two Ankle Pressures Toe Brachial Index Note that the PPG Package model LA5OPG is needed to obtain toe pressures e Arm and Toe Systolic Pressures e Automatic TBI Calculation e Automatic Selection of Arm Pressure higher of the two Seated ABI e Ankle and Arm Systolic Pressures e Automatic Hydrostatic Correction and ABI Calculation e Automatic Selection of Arm Pressure higher of the two e Configurable for one or two Ankle Pressures Waveforms e Bi Directional Doppler e Pulse Volume Recording PVR e Photoplethysmography PPG Reporting e Index and Waveform Printing on Label Paper e Optional Download Capability to PC e Ten patient examination storage locations Doppler Doppler Type Bi Directional Continuous Wave CW Audio Bandwidth gt 4 KHz Waveform Display Digital Mean Frequency Estimator Separate Forward and Reverse Flow Waveforms Available Probe Frequencies 8 43 MHz 5 5 MHz Displayed Waveform Amplitude Accuracy 10 Speaker Output gt 0 25 W Speaker Type 2 5 W Cable length 6 5 ft Volume Control Continuously varia
53. obe steady on the artery press and hold the PUMP key to about 20 mmHg above the occlusion pressure Release the PUMP key and the cuff will automatically start to deflate Press the SAVE key when you hear the first pulsation return If you were late pressing the SAVE key adjust the pressure reading by using the UP or DOWN key Press the SAVE key again to record the systolic pressure and the marker will move to the next protocol location Continue these steps for the remaining sites to complete the exam The Vista ABI makes the hydrostatic correction based on the vertical distance entered prior to obtaining pressures The corrected pressure values will be displayed VISTA TIP e If the calculation for the hydrostatic correction factor results in an ankle pressure that is equal to or less than zero the result is displayed as and the associated Seated Index ST is 0 0 e The PPG probe is not suitable for obtaining pressures in the seated position The Doppler probe is available and recommended e The two pressure modes high or low are not available while performing the Seated ABI MANO024 DFU Rev A 5 13 26 Wallach Surgical Devices SECTION 9 File Management VISTA TIP e Exam reports can be configured for either numeric or alpha character filenames To change the filename configuration use the SYSTEM SETTINGS option see Section 5 for details e tis not possible to alter exam data after a file is saved Saving
54. ol locations Notice that the patient s right hand side is shown on the left side of the Vista ABI s screen in order to match what you see when you face the patient MANO024 DFU Rev A 5 13 16 Wallach Surgical Devices Getting Started Press the ENTER MENU key to open the OPTIONS menu Press the number 6 key to start a new exam You may enter a filename at this time by using the keypad Refer to Section 5 for File Annotation instructions VISTA TIP To start a new study on the current patient press the number 5 key to clear the data except for brachial pressures This is useful when it is determined a TBI will be required following an ABI with noncompressible arteries Obtaining the Right Brachial Pressure Connect the pressure hose to the fitting on the right brachial cuff Apply a small amount of gel over the right brachial artery and place the Doppler probe at approximately 45 degrees pointing in the direction toward the shoulder as shown below Slide the probe laterally across the arm to find the brachial artery and obtain the best signal possible Adjust the volume knob to acquire a proper audio level Once the best signal is obtained brace the hand holding the probe against the patient s arm to ensure a stable position Be careful not to apply too much pressure against the skin Excessive pressure could occlude the artery Next press and hold the PUMP key to inflate the cuff Release the key once the pressure reaches a
55. on and are a valuable addition to the ABI particularly for patients with noncompressible arteries The normal Doppler signal is pulsatile and multi phasic Below is a normal waveform from the PT artery The systolic acceleration and deceleration are rapid These waveforms are tri phasic with two diastolic components Transducer Type 8 MHz Bi Dir Lacation Right The waveform s rise and fall times lengthen as disease progresses A long deceleration is a sensitive indicator of P A D As disease progresses the diastolic components are lost and the waveform becomes mono phasic In addition the weak signals associated with diminished flow produce waveforms that are often more Jagged in appearance e i a i z e Ei E p L ar ad a Tl yI E m E Location Right Above 1s a waveform with the characteristics of abnormal PT flow The acceleration and deceleration times are slow the diastolic components are absent and the waveforms have a somewhat diminished height These waveforms are typical of a patient with mild to moderate arterial disease MANO024 DFU Rev A 5 13 30 Wallach Surgical Devices The characteristics of waveforms acquired at the DP are similar Below is an example of normal DP waveforms This is a bi phasic waveform from a normal patient The signal is pulsatile with a pronounced diastolic component The absence of the second diastolic component without additional evidence is not an indication of disea
56. r the system to comply with the appropriate safety standards A Attention Consult Accompanying Documents MANO024 DFU Rev A 5 13 39 Wallach Surgical Devices Transducer Model LifeDop 5 MHz Bi Dir Operating Mode Continuous Wave cw Application s Peripheral Vascular pcousricoureur_ fom foams sh Global Maximum Value Maximum Value Associated Acoustic Parameter EBD Transducer Model LifeDop 8 MHz Bi Dir Operating Mode Continuous Wave cw Application s Peripheral Vascular Associated Acoustic Parameter Beam Dimensions Ispra3 the derated spatial peak temporal average intensity mwatts per cm Isppa3 the derated spatial peak pulse average intensity watts per cm MI the Mechanical Index P 3 the peak rarefactional pressure megapascals associated with the transmit pattern giving rise to the value reported for MI W the total time average ultrasonic power mwatts f the probe center frequency MHz Zsp the axial distance at which the reported parameter is measured cm X 6 6 are the 6dB beam dim in the x y plane where z is found cm EBD the entrance beam dimensions cm These dimensions are the same as the dimensions of the transmit crystal Measurement Uncertainties Power 34 42 Pressure 11 16 Intensity Ispta 23 26 Frequency 5 Acoustic Output Parameters are measured in water Derated values denoted by the subscript 3 take into account a conserva
57. ra eov Eats eire febri neret acean 37 viser EAS PACCOSSOVICS RE EIL 41 Section 15 Troubleshooting Guide eere e eee eee eee eee eee ee eene eee sssaus 42 Section 16 Clinical References uero eie hoi ope EIS Yo Eoo eia abor eee edes ei eoxu eris ve desee 43 Section 17 AVS Report Software cccccsccsscsssccsscsscsssccscsssssscsssssscsscesssesseess 44 Sec on 18 Warranty aieo eeter ier ios iori PEEL Festes Lieb Donee prie d 60 Section 19 Explanation of Symbols e eere eee eee ee eee eene eene eese s aaaas 61 MANO0024 DFU Rev A 5 13 1 Wallach Surgical Devices SECTION 1 Introduction Thank you for choosing the Vista 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 Year of manufacture located on the device d ad Wallach Surgical Devices 95 Corporate Drive Trumbull CT 06611 USA Here s how you can reach us Phone 1 800 243 2463 203 799 2000 Fax 203 799 2002 email us at customerservice wallachsurgical com visit our website at www wallachsurgical com Important Please read this manual carefully and become familiar with the features operation care
58. rachial Index ABI The Vista 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 Normal 0 91 to 0 99 Borderline equivocal 0 41 to 0 90 0 00 to 0 40 See Section 9 for File Management information including saving printing recalling patient data and for information on how to reset for new patient data MANO024 DFU Rev A 5 13 22 Wallach Surgical Devices SECTION 7 The Toe Brachial Index TBI Examination Please note that an arterial PPG probe and digit cuff sold separately in the PPG package model LAS50PG are needed to perform TBI exams Toe pressures are useful in the assessment of diabetic patients with noncompressible arteries ABI 1 30 and patients with Raynaud s syndrome or with advanced peripheral arterial occlusive disease including the smaller distal vessels Most clinicians do not perform toe pressures on patients with normal ABI results Preparing the Patient Patient preparation for the TBI exam is similar to preparation for the ABI exam however the need to obtain PPG signals from the toes requires consideration of patient temperature It may be more difficult to obtain PPG waveforms if the patient is cold If needed consider laying a blanket over the patient or wrapping a warm towel around the patient s foot Some clini
59. re that there is no loss of data VISTA TIP e Once the LOW BATT indicator begins to flash the battery may become depleted rapidly if a mode that requires additional power is selected such as PUMP Plug in the external power supply as soon as possible once the LOW BATT indicator begins to flash When operating from the external power supply the Vista ABI will switch over to battery power automatically if there 1s a power outage NOTE Charging will not begin if the battery temperature is less than 0 C 32 F NOTE It is important not to unplug the Vista ABI from the wall during an exam This may result in system reset MANO024 DFU Rev A 5 13 35 Wallach Surgical Devices Replacing the battery Tool required Phillips head screwdriver To replace the battery use a Phillips head screwdriver to remove the battery compartment screw Press the latch on the side of the battery connector and unplug the old battery Plug in the new battery and close the battery door Tighten the screw firmly but do not over tighten Charge the new battery for 2 hours before use CAUTIONS e The battery pack contains a temperature measurement component that is matched to the cell type and to the product requirements Use only replacement battery packs as specified by Wallach Surgical Devices e Unauthorized battery substitutions will void the warranty and may cause overheating Used NiMH batteries must be recycled or disposed of properly Do
60. s except decubitus 707 11 Ulcer of thigh 707 12 Ulcer of calf 707 13 Ulcer of ankle 707 14 Ulcer of heel and midfoot 707 15 Ulcer of other part of foot 707 19 Ulcer of other part of lower limb 707 80 Chronic ulcer of other specified sites MANDO024 DFU Rev A 5 13 51 707 80 Chronic ulcer of other specified sites C 710 1 Systemic Sclerosis C 72835 Pain in Limb C 785 40 Gangrene C 997 2 Peripheral Vascular complications not elsewhere classified NolCD 3 Code Dther Wallach Surgical Devices Managing a Report Preferences Windows About File Menu Open cforms CPT IED3 Codes Save Open Close All h Save a5 ows the user to open a previously Export saved report Print Print Preview Printer Select Save Save As Exit Allows the user to select the report name and location for later recovery and backup Close Allows the user to close out of the currently opened file Export Allows the user to generate an Adobe PDF file DICOM 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 MANO024 DFU
61. s been identified that would preclude the prudent and conservative use of diagnostic ultrasound in education and research experience from normal diagnostic practice may or may not be relevant to extended exposure times and altered exposure conditions It is therefore considered appropriate to make the following recommendation In those special situations in which examinations are to be carried out for purposes other than direct medical benefit to the individual being examined the subject should be informed of the anticipated exposure conditions and of how these compare with conditions for normal diagnostic practice MANO024 DFU Rev A 5 13 4 Wallach Surgical Devices SECTION 3 Description of Product and Controls Description of Unit The Vista ABI is a physiologic exam system designed to aid the clinician in the diagnosis of peripheral arterial disease P A D The unit includes a sensitive bi directional Doppler system and a pressure system that provides inflation controlled deflation and pulse volume recording PVR capabilities A PPG package model L450PG for obtaining both toe and limb pressures is available separately This package includes an arterial photoplethysmograph PPG and a digit cuff The Vista ABI is well suited for the ankle brachial index ABI examination the gold standard for the diagnosis of P A D The ABI compares the systolic blood pressure at the ankles with the systolic pressure at the brachial arteries
62. se c V pea sa Pal al Ps E n E Tm t1 i ui e m a i a T iem Lx T a d hd t a aul Continuous wave Doppler waveforms are often considered to be the most useful type of physiological waveform for detecting P A D Doppler waveforms are given a Recommendation of Class I in the ACC AHA P A D Guidelines Hirsch 2005 Pulse Volume Recording PVR Waveform Interpretation PVR serves as a qualitative aid in the assessment of peripheral hemodynamics The waveform contour is useful to confirm the results of the ABI and is a valuable diagnostic tool for patients with noncompressible vessels ABI 1 30 Additionally the PVR can be used to monitor limb perfusion after revascularization Normal plethysmographic 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 xd PVR Cuff UD Am oco En 2 d Cu m Eu ea SS is Ur eu c E C mu l e MANO024 DFU Rev A 5 13 31 Wallach Surgical Devices Distal to an arterial occlusion the waveform becomes more round
63. ssures apply the PPG probe to an index finger for brachial pressures or the great toe for ankle pressures It is important the patient is still and the fingers and toes are reasonably warm To obtain brachial pressures wrap the cuffs around the arms at the brachial artery site Place the PPG on the index finger with the blue side of the probe against the skin It should be snug to ensure contact but not too tight to occlude blood flow as shown below It will take a few seconds for the waveform to stabilize on the display after applying the probe You may want to consider changing the scale of the display to get a better view of the waveform by pressing the SCALE key Once the waveform is stable press the PUMP key to inflate the cuff to a pressure approximately 20 mmHg above the pressure until the PPG pulsations disappear The arm cuff will begin to deflate automatically once the pump stops MANO024 DFU Rev A 5 13 18 Wallach Surgical Devices After the first consistent pulsation returns press the FREEZE key to freeze the waveform on the display Use the caliper tool by pressing the UP or DOWN arrow keys to adjust the pressure reading Move the caliper to the beginning of the first upward slope at the start of the pulsation as shown below This is the systolic pressure Press the SAVE key to save the pressure and move to the next site to be measured Refer to Section 7 for instructions for using the PPG probe to obtain toe pressures Right
64. t DOB 03 311842 Patient Sex F PatlentID 1234567890 Age 68 Exam Date 03 0440 08 31 06 Risk Factors Current Symptoms ABI Severity of Disease D Tobacco Use O Hypertension O Intermittent Claudication Location gt 1 3 Mon compressible Diabetes O Hyperlipidemia L Numbness Tingling in Feet C Buttocks 1 0 1 29N I O Heart Disease O Stroke TIA O Ulcerations C Thigh ae eee C Previous CV Event L Prev Vascular Surgery Dd Rest Pain L calf 0 91 0 99 Borderline 1 pack per smoker D Gangrene Ed Feet 0 41 0 90 Moderate to Mild Resting pain at night 0 00 0 40 Severe Interpreting Physician Or John M Smith Referring Physician Or John M Smith Comments No evidence of PAD RIGHT da LEFT Brachial Brachial 123 120 mmHg mmHg PT PT 135 138 1 12 mmHg mmHg Index DP DP 132 J O 143 1 16 mmHg mmHg Index Higher ABI 1 16 Index 03 0140 08 28 57 PVRX2 03 010 03 31 06 Interpretation CPT Code 93922 Non invasive physiologic studies of upper or lower extremity arteries single level bilateral ICD 8 Code 440 22 Atherosclerosis of native arteries of the extremities with rest pain MANO024 DFU Rev A 5 13 56 Wallach Surgical Devices Completed Sample Seated ABI Report in PDF File Format Lower Extremity Physiologic Study Vascular Facility Single Level Seated ABI Exam 123 Main St Ft Collins CO 80655 Patient Name Ann Johnson Patient DOB 12 12 1957 Patient Sex F Patient ID 12345 Age 67 Ex
65. ter out of paper Paper coming off roll too loosely tighten roll Incorrect paper type Paper roll inserted improperly Unit will not pump Verify that the site cursor is ata BRA or ANK position or at WAV with PVR i e not in Doppler waveform mode also ensure that the hose connection is secure Verify that both ends of the cuff hose are plugged in correctly to the Vista ABI and the cuff Unit will not download Verify that Host PC is running AVS Report Software Software key has been entered properly USB cable is connected There is normally a slight noise threshold that must be overcome waveform is not displayed prior to a waveform being displayed Printed waveform differs from The printed waveform always includes two additional seconds of displayed waveform waveform data Doppler Audio cuts out when Verify proper exam configuration attempting to take an ankle pressure or waveform Unit pumps too slowly PPG using digit cuffs automatically inflate slowly switch to a PPG PKG IS OPTIONAL digit cuff MANO024 DFU Rev A 5 13 42 Wallach Surgical Devices SECTION 16 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 Determin
66. the SCALE key After the first pulsation returns press the FREEZE key to freeze the waveform on the display Use the caliper tool by pressing the UP or DOWN arrow keys to adjust the pressure reading Move the caliper to the beginning of the first upward slope at the start of the pulsation as shown below This is the toe systolic pressure Press the SAVE key to save the pressure and move to the next site to be measured 2d 40 54 Systolic Pulse Reappearance NOTE A substantial shift in the baseline may occur when blood flow returns This is a useful indicator of pulse reappearance Press SAVE or SITE to confirm the value and move to the next exam location Assessment of the Toe Brachial Index The Vista ABI automatically calculates the toe brachial index TBI for both sides The right and left TBI are both calculated using the higher of the two brachial pressures TBI Assessment Above 0 70 0 64 0 70 Below 0 64 MANO024 DFU Rev A 5 13 24 Wallach Surgical Devices SECTION 8 The Seated ABI Examination Performing the ABI in the seated position makes it possible to assess patients who are not able to lie in the supine position for ABI determination These patients may be physically disabled or wheel chair bound patients with degenerative disease of the spine or severe back pain patients with advanced cardiopulmonary disease and orthopnea The Vista ABI is able to calculate ABI values for seated patients by compensatin
67. tive level of attenuation that would be encountered in the human body The derated intensity values I5 are obtained from water values of intensity Iwy at a depth of z calculated by I5 exp 0 23 0 3 f z IL where f is the probe frequency in MHz and z is the depth in centimeters The derated peak rarefactional pressure is calculated from the value of measure water pr by P 5 exp 0 115 0 3 f z p where pressure is given in megapascals Additional Output Reporting Information for IEC 61157 8 MHz I lt 112 mW cm Note that parameter z in the probe reporting tables is the same parameter as I in IEC 61157 Operating Conditions There are no user controls which affect the ultrasound output MANO024 DFU Rev A 5 13 40 Wallach Surgical Devices SECTION 14 Accessories The following accessories and replacement items are available from Wallach Surgical Devices Contact us at 1 800 243 2463 or 203 799 2000 or order on line at www wallachsurgical com Packages PPG Package includes PPG probe amp digit cuff L450PG AVS Software Package PC download capability L450SF MKTO211 software without DICOM and CBL0024 USB cable Cuffs and Tubing Cuff 10 cm CUF0002 Cuff 12 cm CUFO003 Cuff 1 9 cm CUF0004 Cuff 2 5 cm CUFO0005 Hose Set AS YO0OOS Software AVS Report Software with DICOM install by Special Order only MKT0210 Cable USB 6 ft CBLO0024A Printer Paper ABI Printer Label Paper Box of 5
68. ty LifeDop Vista ABI VISTA TIP AVS Report Summit Doppler and Wallach are trademarks of CooperSurgical Inc CPT isa registered trademark of the American Medical Association Clorox is a registered trademark of The Clorox Company Microsoft Word Excel and Windows are registered trademarks of Microsoft Corporation in the United States and other countries Adobe is a registered trademark of Adobe Systems Incorporated O 2013 Wallach Surgical Devices MANO024 DFU Rev A 5 13 61 Wallach Surgical Devices WAILACH SURGICAL DEVICES 95 Corporate Drive Trumbull CT 06611 USA Phone 800 243 2463 203 799 2000 Fax 203 799 2002 customerservice wallachsurgical com www wallachsurgical com Made in the USA MANO0024 DFU Rev A 5 13 Wallach Surgical Devices
69. until contrast level starts over at I and slowly increase the contrast level MANO024 DFU Rev A 5 13 12 Wallach Surgical Devices Setting the Power Down Status The Vista ABI can be set to turn off automatically to save battery power If the automatic power down is set to ON the unit will turn off after 20 minutes automatically after the last key press If the automatic power down is set to OFF the unit will not turn off until either the user presses the ON OFF button or the battery becomes low i 2 3 4 Press ENTER MENU to open the OPTIONS menu Press the number 2 key to select SYSTEM SETTINGS Press the number 3 key to toggle the power down value to ON and OFF After setting the desired value press ENTER MENU to exit the OPTIONS menu Setting the Ankle Protocol The Vista ABI can be set to accommodate protocols that use either one pressure measurement or two pressure measurements from each ankle The DUAL ANKLE PRESSURE mode will be set to OFF for a single ankle pressure For protocols that use measurements from both the dorsalis pedis DP and the posterior tibia PT arteries select HIGH or LOW to select the desired protocol with second ankle pressure l 2 3 4 Press ENTER MENU to open the OPTIONS menu Press the number 2 key to select SYSTEM SETTINGS Press the number 5 key to toggle the ankle value between OFF HIGH or LOW After setting the desired value press ENTER MENU to exit the OPTIONS menu
70. ures or waveforms using the Doppler probe but it is not audible when rubbing the probe tip the system is probably set in PPG mode To change the setting go to the System Settings menu and select Doppler for obtaining pressures and waveforms MANO024 DFU Rev A 5 13 14 Wallach Surgical Devices Entering a Filename Prior to Beginning an Exam If beginning a new exam by pressing the number 6 key for NEW EXAM CLEAR ALL under the OPTIONS screen the system will display the ENTER FILENAME message This message ensures that the user 1s aware that the patient data will not be automatically saved After completing the exam the user can save the data by following the instructions provided in the Saving a File paragraph of Section 9 ENTER FILE NAME Enterins the pile DART at this time does D cat data at end of After ex am the dat File Managen Save functio Oe7 29 Z009 14 62 store the Patient Name or ID ress ENT TER _to Cancel or Press nu other eu oO Proceed If a current exam is not saved and the user selects either NEW EXAM CLEAR ALL or NEW EXAM KEEP BRACHIALS under the OPTIONS screen the system will display the UNSAVED DATA message below to let the user know that the previous data was not saved Press the ENTER MENU key to ignore this message and start a new exam the ENTER FILENAME will appear or press the SAVE key to save the data and the SAVE FILE menu will appear MANO024 DFU Rev A 5 13 15 Wa
71. volume that occur with each heart beat The PVR waveform s contour is a qualitative indicator of presence or absence of peripheral arterial disease This type of PVR does not permit calibration by injection of a known air volume and is used for arterial waveform analysis Photoplethysmography PPG is an optoelectronic technique for detecting the small changes of blood volume that occur in the capillary bed Infrared IR light is emitted by the PPG probe into the skin Light reflected from the underlying tissue 1s received by a detector and converted to an electrical signal Since blood attenuates IR light at a higher level than the surrounding tissue the signal s pulse contours are determined by the arterial blood supply This type of PPG system is primarily for arterial pulse detection MANO024 DFU Rev A 5 13 5 Wallach Surgical Devices In conjunction with a digit cuff arterial PPG is quite useful for toe pressure measurement which is an additional diagnostic tool when the arteries at the ankle are noncompressible ABI gt 1 30 due to calcification Calcified arteries are prevalent among patients with diabetes or kidney disease but the small arteries of the toes seldom become calcified When the Vista ABI is configured for PPG the system automatically calculates the toe brachial index TBI A low TBI lt 0 65 indicates an arterial obstruction The TBI is discussed in Section 7 The Vista ABI includes everything that is needed to co

User Manual for Vista ABI

Contents

Download Pdf Manuals

Related Search

Related Contents