Vista AVS User Manual Rev A May 2013

TABLE OF CONTENTS (Vista AVS) Section 1:

Introduction... 1

Section 2:

Safety Information ... 2

Section 3:

Description of Product and Controls ... 5

Section 4:

Preparation for Use... 9

Section 5:

Menu Configuration and Set Up ... 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 ... 25

Section 9:

Segmental Studies ... 27

Section 10: Individual Site Mode... 29 Section 11: File Management... 30 Section 12: Peripheral Arterial Waveform Interpretation... 33 Section 13: Maintenance and Cleaning... 36 Section 14: Battery Recharging and Replacement ... 38 Section 15: Specifications ... 40 Section 16: Accessories ... 45 Section 17: Troubleshooting Guide... 46 Section 18: Clinical References... 47 Section 19: AVS ReportTM Software... 48 Section 20: Warranty ... 64 Section 21: Explanation of Symbols... 65

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SECTION 1: Introduction

Thank you for choosing the Vista AVS from Wallach Surgical Devices. We believe you have purchased the finest arterial examination system 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 longterm relationship with you! Wallach Surgical Devices 95 Corporate Drive Trumbull, CT 06611 USA

Year of manufacture located on the device.

Here’s how you can reach us... Phone: 1-800-243-2463 (203) 799-2000 Fax: (203) 799-2002 Email us at: [email protected] Visit our website at www.wallachsurgical.com Important: Please read this manual carefully and become familiar with the features, operation, care, and safety requirements of the Vista AVS prior to use. Please note that while operating the Vista AVS, 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.

U.S. Patent Pending

Package Contents The Vista AVS unit includes the following: - User Manual - 17 cm Cuffs (2) - Quick Guides - Printer Paper - ABI Chart - Tape Measure - Hand Controller - Hose Set - Digit Cuff - ABI Report Forms - 10 cm Cuffs (2) - PPG Probe - 12 cm Cuffs (4) - Training Video

- Ultrasound Gel - Stand with Basket & Knobs (L500VA only) - 8 MHz Bi-Directional Probe - AVS Report Software - USB Cable - Power Supply (+7 VDC) & cable

The following are optional and sold separately from the Vista AVS. - 5 MHz Bi-Directional Probe - Carrying case MAN0014-DFU • Rev. A • 5/13

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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 is not intended for fetal use. General Warnings: WARNINGS • The Vista AVS 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 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 (i.e. IEC 950 for data processing equipment, IEC 60601-1 for medical equipment). Contact the technical service department for more information.

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General Cautions: CAUTIONS • Do not plug the probe cables into a telephone system, computer, or any equipment other than the Vista AVS. • Read the Maintenance and Cleaning Section (Section 13) before cleaning. • 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 AVS 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 Artificially elevated high-thigh pressure in very large or obese patients Difficult interpretation of segmental pressures in patients with multilevel occlusive disease 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: The Vista AVS 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.

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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 has 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.

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SECTION 3: Description of Product and Controls Description of Unit The Vista AVS 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, arterial photoplethysmograph (PPG), and a pressure system that provides inflation, controlled deflation, and pulse volume recording (PVR) capabilities. The Vista AVS 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. 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 AVS: 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 is sufficient. Waveform analysis is discussed in Section 12. The Vista AVS is designed to perform segmental studies to compare three or more lower limb pressures to the brachial pressures. This procedure is reimbursable under CPT code 93923 as a non-invasive, physiologic study of upper or lower extremity arteries, multiple levels or with provocative functional maneuvers, complete bilateral study. 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 is applied to the limb and inflated to 65 mmHg to detect the minute fluctuations in limb volume that occur with each heart beat. The PVR waveform’s contour is a qualitative indicator of presence or absence of peripheral arterial disease. 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 is received by a detector and converted to an electrical signal. Since blood attenuates IR light at a higher level than the surrounding tissue, the signal’s pulse contours are determined by the arterial blood supply.

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This type of PPG system is primarily for arterial pulse detection. 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 > 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 AVS is configured for PPG, the system automatically calculates the toe brachial index (TBI). A low TBI (<0.65) indicates an arterial obstruction. The TBI is discussed in Section 7. The Vista AVS includes everything that is needed to conduct fast, efficient peripheral arterial examinations including display, printer, Doppler probes, PPG probe, pressure hose, limb pressure cuffs, and a digit cuff. 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

FEED - Printer feeds paper while pressed

CHARGING - On: Charging - Flashing: Charging complete (trickle charging while flashing) LOW BATT - Flashing: Low battery

PAPER RELEASE - Blue button under paper dispenser: Opens printer cover

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Display Screen - Protocol Location and Markers Pressure Gauge (mmHg) Right & Left ABI Right & Left Brachial Sites Waveform Sites (Right & Left PT or DP) Right & Left Ankle Sites (PT or DP) (Toe Sites when in PPG Mode) Date and Time Step-By-Step ABI Instructions

Hand-Held Controller PUMP

- Pump runs while pressed

SAVE

- During deflation- Stores current cuff pressure and deflates - Active waveform- Stores waveform data - Frozen waveform- Stores the frozen waveform - 2nd button press- Confirms the stored pressure or waveform

FREEZE

- Active waveform- Freezes the displayed waveform - Frozen waveform- Starts new waveform acquisition

SITE

- Moves the protocol marker to the next location - Saves data before leaving old protocol location

SCALE

- Changes the waveform scaling

PUMP

SAVE

FREEZE

SITE

SCALE

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MUTE

- Enables/disables Doppler speaker output

PRINT

- Prints out the waveform on adhesive-backed label paper

ENTER/MENU

- Enters the displayed value or makes a menu selection - Also used to open the OPTIONS screen

UP

- Navigates through the menu in the up direction & moves the caliper tool to adjust the pressure values

DOWN

- Navigates through the menu in the down direction & moves the caliper tool to adjust the pressure values

MUTE

PRINT

ENTER/MENU

UP

DOWN

Numeral Mode

Character Mode

1

Numeral 1

2

Numeral 2

A, B, C

3

Numeral 3

D, E, F

4

Numeral 4

G, H, I

5

Numeral 5

J, K, L

6

Numeral 6

M, N, O

7

Numeral 7

P, Q, R

8

Numeral 8

S, T, U

9

Numeral 9

V, W, X

0

Numeral 0

Y, Z

Space

Space

Hyphen

Hyphen

SPACE

See Section 5 for information on how to change between Character and Numeral Modes.

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SECTION 4: Preparation for Use Tools required: Phillips head screwdriver

1. Unpack the Vista AVS 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 a Phillips head screwdriver to attach the Vista AVS 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 AVS.

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.

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VISTA TIPTM: • For first time use, allow the unit to charge for at least one hour before operating the Vista AVS from its battery.

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 into the PPG connector. (Black port) VISTA TIP: • 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 AVS is connected to a PC via the USB port. Connectors

Doppler

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Hand Controller

USB

10

+ 7 VDC (Power)

Cuff

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SECTION 5: Menu Configuration and Set Up Loading Paper:

The Vista AVS 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.

WARNING • Printer components become hot during printing. Do not touch the metal pieces inside the paper holder immediately after printing. After loading paper, press the ON/OFF switch to begin using the instrument. Configuring the Examination

The Vista AVS 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 PVR Waveform 2 – ABI with Doppler Waveform 3 – TBI with PVR Waveform 4 – TBI with Doppler Waveform 5 – Segmental with PVR Waveform 6 – Segmental with Doppler Waveform

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VISTA TIP: • The current configuration mode will be displayed at the bottom of the waveform upon returning to the main screen. Setting the Date and Time

1. 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 AVS 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: • If there is flickering or shadowing on the text, the contrast is adjusted too high. Readjust contrast level by pressing the number 2 key until contrast level starts over at 1 and slowly increase the contrast level.

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Setting the Power Down Status

The Vista AVS 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. 1. Press ENTER/MENU to open the OPTIONS menu. 2. Press the number 2 key to select SYSTEM SETTINGS. 3. Press the number 3 key to toggle the power down value to ON and OFF. 4. After setting the desired value, press ENTER/MENU to exit the OPTIONS menu. Setting the Ankle Protocol

The Vista AVS 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. 1. Press ENTER/MENU to open the OPTIONS menu. 2. Press the number 2 key to select SYSTEM SETTINGS. 3. Press the number 5 key to toggle the ankle value between OFF, HIGH or LOW. 4. After setting the desired value, press ENTER/MENU to exit the OPTIONS menu. 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: 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 4 key to toggle between NAME or NUMBER modes. 4. 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. 5. Press the SAVE key to save the filename and begin the exam.

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Selecting a Modality for Obtaining Pressures

Choose between the Doppler probe and 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.

Modality – Doppler probe

VISTA TIP: • If you’re trying to obtain pressures 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.

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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 is 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 in Section 11.

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.

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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.

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 AVS 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 protocol locations. • Notice that the patient’s right hand side is shown on the left side of the Vista AVS's screen in order to match what you see when you face the patient.

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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 about 20 mmHg above the occlusion pressure. After the pump stops the Vista AVS 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.

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Doppler Waveform During Acquisition of Systolic Pressure

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. • During deflation, pressing PUMP again will re-inflate the cuff and allow a new pressure to be taken. OBTAINING PRESSURES USING THE PPG PROBE:

In the supine position, ABI pressures can also be obtained using the PPG probe. For obtaining pressures, 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.

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