LifeDop ABI Handheld Vascular System User Manual Rev A April 2013

Thank you for choosing Summit Doppler products. We believe you have purchased the finest handheld Doppler and portable printer on the market. Your total satisfaction is our highest priority as we strive to continually improve our products and services. Please contact us with any suggestions. We look forward to enjoying a long-term relationship with you! Wallach Surgical Devices 95 Corporate Drive Trumbull, CT 06611 USA

Year of manufacture located on the device.

Here’s how you can reach us Phone: 1-800-243-2463 (203) 799-2000 Fax: (203) 799-2002 e-mail us at: [email protected] visit our website at: www.wallachsurgical.com Table of Contents: Page Intended use/Contraindications/Warnings ...1 Description of Product ...2 Operation and Installation ...3 ABI Diagnostic Examination Procedure ...5 Obtaining Doppler Signals and Printer Operation ...9 Connecting the Printer ...9 Printing a Waveform ...10 Report Generation ...11 Diagnostic Monitoring ...12 Accessories ...12 Maintenance and Cleaning ...12 Replacing LifeDop Batteries ...13 Recharging Printer Batteries ...14 Troubleshooting ...14 Clinical References ...15 Specifications ...16 ABI Glossary Guide ...18 Sample Completed Forms ...21 Warranty ...23 Explanation of Symbols ...24 Please read the manual carefully and become familiar with the operation, features and maintenance of your Doppler prior to using the device or accessories.

(This mark excludes the PSS® Model: 1153)

MAN0007-DFU • Rev. A • 4/13

i

Wallach Surgical Devices

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.

Intended Use This product will be used to detect blood flow in veins and arteries for assisting in the detection of peripheral vascular disease. Caution • U.S. Federal law restricts this device to sale by or on the order of a licensed practitioner.

Contraindications Warnings • The vascular probes are not for fetal use. • The ultrasound probes are not to be used on or near the eyes. • The device is for use only on intact skin. • Do not plug any part of this device into a telephone or modem. • This device is not intended for use with HF surgical equipment. If there are questions or concerns regarding these warnings or contraindications, please do not hesitate to contact Wallach Surgical Devices for further clarification.

In order to preserve, protect and improve the quality of the environment, protect human health and utilize natural resources prudently and rationally – do not dispose of waste electrical or electronic equipment (WEEE) as unsorted municipal waste. Contact local WEEE disposal sites. Safety of Ultrasound The Doppler un it was designed with physician and patient safety in mind. In early design phases all potential hazards were eliminated or reduced to As Low As Reasonably Achievable (ALARA) by adhering to good design practices and industry wide safety standards. Ultrasound procedures should be performed with the ALARA principle in mind when delivering ultrasound energy into the body. The following official statements from the American Institute of Ultrasound Medicine (AIUM) are provided for your general information regarding the safe use of ultrasound. Clinical Safety Approved 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 indicate that the benefits to patients of the prudent use of diagnostic ultrasound outweigh the risks, if any, that may be present. MAN0007-DFU • Rev. A • 4/13

1

Wallach Surgical Devices

Safety in Training and Research Approved 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.

Description of Product ®

The Summit LifeDop ABI System is factory configured to include many features and product enhancements. Along with interchangeable ultrasound transducers, the Summit Doppler device is well suited to meet your specific needs. Main Unit The main handheld unit is ergonomically designed to fit the palm of your hand with comfort and allow easy access to each control feature. Each unit is individually tested and inspected to ensure the highest quality standards. Printer Download – The LifeDop buffers 4 seconds of waveform data and waits until the printer is ready to print out a record of the examination. LCD Display – The LCD display allows you to view information in large easy to read digits including probe ID, battery life, signal strength indicators, and multiple diagnostic indicators that ensure your unit is functioning at peak performance levels. SSQ – Superior Sound Quality. LifeDop ABI is designed with a state-of-the-art sound system that produces excellent sound quality and long-term reliability. Probe Summit Doppler ultrasound transducers were designed to meet your specific application need. Each probe has been ergonomically designed for comfort while providing excellent maneuverability for locating the vascular target. Every probe is carefully measured and tested to ensure it meets exacting performance standards. 8 MHz Bi-Directional Probe – This standard “pencil” style probe is an excellent vascular tool for locating specific shallow vessels in the peripheral vascular system. The narrow grip and small face of the probe make it ideal for maneuvering for maximizing the signal in both flow directions. 5 MHz Bi-Directional Probe (optional) – This “pencil” style probe, with wide beam and deep penetration, is designed for locating deep vessels in the peripheral vascular system. The narrow grip is easy to maneuver.

MAN0007-DFU • Rev. A • 4/13

2

Wallach Surgical Devices

Operation and Installation

SPEAKER GRILL

ON/OFF BUTTON

PROBE CLIP

PROBE CONNECTOR

HEADPHONE CONNECTOR PRINTER CONNECTOR

PRINT BUTTON

Side Panel Controls

MAN0007-DFU • Rev. A • 4/13

3

Wallach Surgical Devices

(NOT USED)

(NOT USED)

(NOT USED)

LCD Display

(NOT USED)

Printer

MAN0007-DFU • Rev. A • 4/13

4

(NOT USED)

Wallach Surgical Devices

A comprehensive In-Service Training Video (disk) is provided with your handheld doppler.

Turning Unit On/Off Turn the LifeDop on by pressing the On/Off button. LCD indicators show power status. The LifeDop automatically shuts itself off after 5 minutes if it is not being used. Turn the Printer on by pressing and holding the On/Off button until the green LED comes on (approximately 3 seconds). Printer automatically shuts itself off after 30 minutes.

Volume Slider The audio level can be adjusted using the Volume Slider. Moving the slider up will increase the volume, while moving it down will decrease it. The volume slider does not affect the headphone output.

ABI Diagnostic Examination Procedure Setup 1. In a warm room, have the patient take off shoes and socks and rest in a supine position for approximately 5 minutes prior to taking pressures. Patient should wear thin, loose fitting clothing. Avoid rolling up sleeves or pant cuffs in such a manner that it obstructs blood flow [1]. Bulky items such as sweaters should be removed. 2. Wrap the cuffs snuggly around the arms and ankles as shown below (Figures 1 and 2). 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 [1].

Figure 2

Figure 1

While applying the cuffs, it may be a good time to explain the examination to the patient and answer any questions they may have during this period. Brachial Pressures 3. Apply a small amount of gel to the brachial artery site and place the Doppler probe at approximately 45 degrees, pointing in the direction toward the shoulder as shown in Figure 3. Slide the probe laterally across the right arm to find the brachial artery and obtain the best signal possible. 4. Find a stable and comfortable position to brace the probe hand while quickly inflating the cuff 20 mmHg above the occlusion pressure; at this point Doppler sounds are no longer heard. Be sure that the Doppler probe stays on the artery during inflation [2].

Figure 3

5. Deflate the cuff at approximately 2 mmHg per second by gently squeezing the pressure release trigger on the inflator. Listen for the blood flow sounds to return. When the flow sounds return, this is the systolic pressure. Once this pressure is obtained, rapidly deflate the remaining pressure in the cuff [2].

MAN0007-DFU • Rev. A • 4/13

5

Wallach Surgical Devices

6. Repeat this process for the left arm and record the results on the ABI Assessment Chart as shown in Figure 4.

Figure 4

7. The greater of the two pressures will be used to calculate the ABI. A pressure difference of 20 mmHg or more between the two brachial sites is an indication of upper extremity stenosis. The pressures should be re-confirmed and further testing should be considered if repeatable [2]. Right Ankle PT Pressures and Printout 8. Before the right ankle systolic pressures are determined a waveform is required. Acquire the Doppler signal at the PT as shown in Figure 5. Apply a small amount of gel to the site and angle the Doppler probe at approximately 45 degrees, pointing the probe tip in the direction toward the calf and knee. Slide the probe slowly across the site until the best signal is obtained. Ideally, strong tri-phasic flow can be heard, however, in cases of restricted flow, the best signal may only be bi-phasic or mono-phasic. It is helpful to monitor the signal bars on the display to observe the directionality of the waveform prior to storing and printing. (Cuff inflation is not used for obtaining waveforms.)

Figure 5

To print the waveform: Maintain the best signal possible for a minimum of 4 seconds and press the red button on the side of the LifeDop to buffer the waveform for printing. Turn on the printer and connect the cable. Once the printer communication with the LifeDop is established, the waveform will begin to print. 9. Apply the printed Doppler waveform to the ABI Assessment form by folding the printout in half lengthwise and peeling the protective paper from the label as shown in Figure 6. For more details, refer to the “Printing a Waveform” section. Then check the appropriate boxes on the form to indicate the vessel location and complete the form by filling in the patient risk factors and symptoms.

Check box portion of the form

Figure 6

MAN0007-DFU • Rev. A • 4/13

6

Wallach Surgical Devices

10.

For right ankle systolic pressures, use the Posterior Tibial (PT) artery. Refer to Figure 5. Find a stable and comfortable position to brace the probe hand while quickly inflating the cuff 20 mmHg above the occlusion pressure when Doppler sounds are no longer heard. Be sure that the Doppler probe stays on the artery during inflation [2].

11.

Deflate the cuff at 2 mm Hg/sec by gently squeezing the pressure release trigger on the inflator. Listen for the blood flow sounds to return - this is the systolic pressure. Once blood flow returns, rapidly deflate the remaining pressure in the cuff [2]. Note:

If the ankle pressure is significantly greater than the higher of the two brachial pressures, the artery may be calcified and non-compressible. The pressures should be re-confirmed and further testing should be considered if repeatable[3].

Right Ankle DP Pressures 12. For right ankle systolic pressures, use the Dorsalis Pedis (DP) artery. Refer to Figure 7. Find a stable and comfortable position to brace the probe hand while quickly inflating the cuff 20 mmHg above the occlusion pressure when Doppler sounds are no longer heard. Be sure that the Doppler probe stays on the artery during inflation [2]. 13.

14.

Deflate the cuff at 2 mm Hg/sec by gently squeezing the pressure release trigger on the inflator. Listen for the blood flow sounds to return - this is the systolic pressure. Once blood flow returns, rapidly deflate the remaining pressure in the cuff [2].

Figure 7

Repeat this process for the left ankle and record the systolic pressure results on the ABI Assessment Chart. Note:

If the ankle pressure is significantly greater than the higher of the two brachial pressures, the artery may be calcified and non-compressible. The pressures should be re-confirmed and further testing should be considered if repeatable[3].

Calculate the ABI and Complete the Form 15. For the left side ABI, divide the left ankle pressure by the higher of the two brachial pressures and record the result. This can be done with a calculator or by using the provided ABI Calculator Chart. Repeat this step for calculating the right side ABI, again using the higher of the two brachial pressures [3].

MAN0007-DFU • Rev. A • 4/13

7

Wallach Surgical Devices

16.

Figure 8 shows a sample completed form. Other examples of completed forms are located in the rear of this document.

Figure 8

References: [1]

Human Blood Pressure Determination by Sphygmomanometery: American Heart Association (AHA), 2001

[2]

Techniques in Noninvasive Vascular Diagnosis – an Encyclopedia of Vascular Testing; Daigle RJ, Summer Publishing, 2002: 137-148

[3]

Olin JW. Clinical Evaluation and Office-Based Detection of Peripheral Arterial Disease, contained in Primary Care Series: Peripheral Arterial Disease and Intermittent Claudication; Hirsch AT (Ed), Excerpta Medica, Inc., 2001

MAN0007-DFU • Rev. A • 4/13

8

Wallach Surgical Devices

Obtaining Doppler Signals and Printer Operation Caution • Doppler examinations should be performed only by trained individuals. For any Doppler examination, it is essential that an adequate supply of coupling gel be used to transmit the ultrasound energy from the probe to the surface of the skin. Re-apply more gel if it starts to dry out or spread so thinly that an air gap occurs between the probe and the skin. It is not necessary to cover the entire surface of the probe, only the probe face. Applying too much gel makes the unit difficult to clean and does not aid in the performance of the probe. For the best results, angle the probe approximately 45 degrees from the skin surface over the general location of the vessel. Slowly move the probe side to side and vary the angle of the probe until the vascular sounds are heard. Changing the angle of the probe has an effect on the frequency of the sound. The steeper the probe angle, the higher the frequency of the sound.

Signal Quality Indicator Once flow sounds are found, the signal strength indicators give the user a visual display of the flow direction and relative strength of the signal. Four bars of the left indicate flow toward the probe, while the four bars to the right indicate flow away from the probe. Vary the probe position and angle as described above while viewing the indicators to obtain the best results.

Buffering a Waveform Once the desired flow is found, press the red “PRINT” button on the side of the unit to buffer the PREVIOUS four seconds of flow. When the waveform is buffered, as indicated by “STR” on the display, the probe is temporarily shut off and can be removed from the patient. The printer need not be connected to buffer the waveform - the LifeDop waits until the printer is ready. Note: Only one waveform can be buffered at a time and the LifeDop must remain ON in order to retain the waveform.

Connecting the Printer Ensure that the printer is loaded with paper and connect the cable to the printer and LifeDop as shown, with connector tabs down as labeled “THIS SIDE UP”. Turn the printer on by HOLDING the power button down (approx. 3 seconds) until the LED comes on. If the printer is functioning properly and ready to print, the LED will flash green twice every second. Warning • Forcing the cable upside down will cause damage to the connector pins on the LifeDop, cable and printer. Note label “THIS SIDE UP”. MAN0007-DFU • Rev. A • 4/13

Printer Connections 9

Wallach Surgical Devices

Note:

When turning the printer on or off, it is important to remember to hold the button down, approximately 3 seconds, before the printer will respond.

Warnings • Install the paper roll in the printer so the external side (heat sensitive side) of the rolled paper is against the print head (down). • Do not use printer paper other than the type specified and supplied with the Summit Doppler. Other paper types could result in damage or degraded print quality and may void the warranty.

Loading Paper

Printing a Waveform

Warnings • The print head becomes hot during printing. Do not touch the print head after printing. • Turn off the printer and check that the head is fully cooled before attempting to fix a paper jam, replacing paper, or removing the print roller for any reason. Once the printer is operational and the cables are in place, the LifeDop will automatically download the waveform and printing will begin. If the PRINT button is pressed while the printer is connected and ready, printing will start immediately. Waveforms are automatically scaled to a maximum frequency of 1 kHz, 2 kHz or 4 kHz for optimal waveform height. Markings on the vertical axis are provided every 1 kHz. Printer calibration is not required.

Auto-Scaling – 1 kHz, 2 kHz and 4 kHz

Sample Printout Blood flow in the direction toward the probe is shown above the baseline. Flow away from the probe is shown below the baseline. These two traces are provided so that flow in both directions can be displayed simultaneously.

MAN0007-DFU • Rev. A • 4/13

10

Wallach Surgical Devices

Report Generation Report generation is made very simple with adhesive-backed printer paper provided by Wallach Surgical Devices eliminating the need to cut and tape the strip of paper. The label paper backing is precut down the center – fold the paper down the middle and peel from the center. Attach the waveform to the pre-printed ABI Assessment Form.

ABI Assessment Form with one waveform strip in place

MAN0007-DFU • Rev. A • 4/13

11

Wallach Surgical Devices

Diagnostic Monitoring All LifeDop Doppler units perform continuous diagnostic monitoring and give a visual indication of battery level. The LifeDop uses a multiple level battery shaped icon that indicates the voltage level of the battery. The battery outline will flash when the battery level is very low, indicating that the user should change the batteries soon after the current examination is complete. Once the unit is on, the LifeDop performs a series of diagnostic checks. The unit first checks and displays the frequency of the probe that is being used. This display will not change unless the probe is changed or the power is cycled, in which case the display will again temporarily confirm the frequency of probe that is connected. The unit then checks for proper internal operating temperature, battery voltage, reference voltage and power supply voltage levels. If any of these characteristics are out of range, the display will show the ERROR indicator and a failure code associated with the diagnostic error. Diagnostic functions are periodically checked while the unit is on to ensure the Doppler is operating at peak performance. Refer to the table below for failure codes. Diagnostic Codes – Contact Wallach Surgical Devices Service Department 1 – Temperature too low 6 – 5 Volt Supply too high 2 – Temperature too high 7 – Battery Voltage too low 3 – Reference Voltage too low 8 – Battery Voltage too high 4 – Reference Voltage too high 9 – Printer miscommunication 5 – 5 Volt Supply too low The printer will perform a self-test print by turning the printer on while the feed button is being held down. A checkered test pattern will print in addition to the printer configuration and loaded fonts.

Accessories To order accessories [gel, batteries, rechargers, printer paper (labels), cables], contact Wallach Service at 1-800-243-2463 or (203) 799-2000 to order by phone, or order on-line on our website www.wallachsurgical.com

Maintenance and Cleaning Warnings • The LifeDop is not designed for liquid immersion. Do not soak the Doppler main unit or probes in liquids. Use only spray or wipe cleaners and disinfectants. Do not use products containing bleach. • The LifeDop is not designed for sterilization processes such as autoclaving, gamma radiation, or hydrogen gas. • The LifeDop is not intended to be used on open skin. If there is evidence of open wound contamination, disinfect the probe before using again as described below.

MAN0007-DFU • Rev. A • 4/13

12

Wallach Surgical Devices

The LifeDop Doppler requires very little maintenance. However, it is important to continuing function of the unit and the health of the patients that the unit is cleaned and examined regularly per the following guideline: After every examination: Excess gel should be wiped off prior to docking the probe. Probes and main unit should be cleaned with a damp cloth using warm water or presaturated isopropyl alcohol wipes. In particular, pay close attention to clean the seams along the plastic lines at the probe face but do not allow water or spray to enter through the connectors or speaker grill. To disinfect unit, use commercially available spray or wipe disinfectants registered with the EPA. Clorox® Broad Spectrum Quaternary Disinfectant is the only disinfectant that is Wallach Surgical Devices approved for use with the L250 ABI product. Follow the manufacturer’s instructions and wipe unit until it is dry of solutions. Examiners should wash hands and change gloves after every exam. Refer to local and hospital policies for cleaning and disinfection policies. Store the unit in a clean area free from dust and debris. Follow temperature and humidity guidelines as specified at the end of this manual. Warning • If the unit is to be stored for longer than 90 days without use, remove the batteries prior to storage. Periodically (at least annually): Inspect the main unit and probes for signs of cracks or breaks in the mechanical housing. Inspect cables and connectors for signs of wear or failure. The user should discontinue use of the unit with any sign of loss of housing integrity. Contact Wallach Surgical Devices for service. It is recommended that rechargeable batteries be replaced annually.

Replacing LifeDop Batteries Warning • Replace batteries only with batteries supplied by Wallach Surgical Devices. The battery compartment only accepts AA size batteries. See the Accessories section for reordering of parts information. Open the battery compartment by depressing the tab and pulling outward on the battery door. Remove the existing drained batteries by pushing on the end of the battery that compresses the battery contact spring and lift upwards. It is acceptable to use a small tool or pen to assist in this step.

Replace the batteries by paying close attention to the polarity indicators on the battery and the polarity indicators on the battery holder in the compartment. Positive (+) aligns with positive (button) and negative (-) aligns with negative (spring). Insert the battery such that the spring contacts are loaded first and then press the battery firmly into place. Warning • If the batteries have been inserted incorrectly, the unit will not function but the LifeDop will not be damaged.

MAN0007-DFU • Rev. A • 4/13

13

Wallach Surgical Devices

Recharging Printer Batteries Warnings • Use only the battery and AC adapter supplied with the printer. Use of any other battery and/or AC adapter is hazardous and may cause damage to the equipment. • Do not connect the printer to the Doppler while the printer is charging.

It is recommended that the printer be recharged prior to first use. Turn the printer off. Lift the rubber flap on the left side of the printer and plug in the connector of the recharge adaptor. Make sure recharger is plugged into a standard 120VAC outlet. When properly connected, the LED will be red. Upon completion of charging the LED will turn off. Remove the recharger and replace the rubber flap.

Printer Recharger

Troubleshooting Warnings • Use alternate equipment in case of unit failure. Call the Wallach Surgical Devices Service Department if the probe or main unit malfunctions. • Do not drop or mishandle the LifeDop, probes or accessories. Damage to sensitive electrical components, speakers, cables, transducers or plastic is likely to occur. Poor sound quality Inadequate gel use Try to relocate the probe for a better signal Improper choice of probe Frequency Interference from other equipment Probe coiled cable or battery contacts may be intermittent Debris in the speaker may cause poor sound Device damage from dropping the LifeDop, probes or accessories Battery indicator flashing – Error 5 or Error 7 Consult the Diagnostic Monitoring Section; replace batteries as described in Replacing Batteries. Probe frequency does not match the connected probe Check probe that is attached to ensure it is the correct one, or no probe attached. If the correct probe is being used, contact Wallach Surgical Devices’ Service Department. Radio Frequency Interference The LifeDop was tested for immunity to electromagnetic interference at a level of 3 V/meter. Interference during normal operation may occur in the presence of fields stronger than 3 V/meter. If this occurs, try to increase the distance between the LifeDop and the source of interference. Contact Wallach Surgical Devices for more information.

MAN0007-DFU • Rev. A • 4/13

14

Wallach Surgical Devices

Printer LED Red or Orange Green Orange LED LED Flash 2x

Red LED Flash

Flash 1x Flash 2x Flash 3x Flash 4x

Error

Solution

No Error Low Battery Out of Paper Open Cover Thermal Failure Voltage Failure

Normal Recharge Reload Paper Close Cover Call Wallach Call Wallach

Printer DIP switches are preset at the factory. The printer will not function properly if they are moved from these set positions. Printer Not Printing (Error 9) The LifeDop and printer have lost communication. This may be due to a printer jam, paper empty, low printer battery or any of the above printer error codes. To clear the error, lift the paper cover lever, reseat the paper roll and close the cover. If printer communication is re-established, the LifeDop will automatically print the buffered waveform. If Error 9 persists, turn off both printer and LifeDop and re-start waveform buffer. Waveform appears to be the same above and below the base line This anomaly normally occurs when the probe is close to perpendicular to the vessel. Reacquire the Doppler signal with the probe angle at 45 degrees as described in Obtaining Doppler Signals. Faint signal is audible, but waveform is not obtained on printout The LifeDop main unit is designed to reject noise and certain artifacts. Even a valid signal must reach a threshold before it can be printed; therefore it is normal for some very weak signals to be rejected. Printer Switches not set in proper location The printer switches have been preset at the factory to the proper location; however if they have been changed the printer will not function. Orient the printer and set the DIP switches to match the following: 1 – Up 2 – Down 3 – Down 4 – Down

Reference materials for Peripheral Vascular testing: Noninvasive Diag of Peripheral Vascular Disease; W. Robert Felix, Jr., 1988 Current Noninvasive Vascular Diagnosis; Ali F. Aburahma, Edward B. Diethrich, 1988 Vascular Disease Foundation; www.vdf.org American Heart Association; www.americanheart.org American Diabetes Association; www.diabetes.org

MAN0007-DFU • Rev. A • 4/13

15

Wallach Surgical Devices

Specifications Degree of protection against electric shock: Type B Applied part Class II Equipment Degree of protection against ingress of water: IPX4 – extending 2.5 cm from tip IPX1 – entire probe 2.5 cm from tip, excluding connector Designed and tested to meet: IEC601-1, IEC60601-1-2, IEC60601-1-4, IEC60601-2-37, EN5011-A Connect the LifeDop only to equipment that meets the appropriate standards. Dimensions (h x w x l): Weight:

LifeDop 140 x 70 x 35 mm 320 grams

Printer 136 x 84 x 43 mm 280 grams

Operating temperature: 10 to 40 °C 0 to 40 °C Operating humidity: 30 to 75 % 20 to 85 % Transport/Storage temp: –20 to 50 °C –20 to 60 °C Transport/Storage humidity: 5 to 90%, non-condensing for both units (beyond 30 days, battery to be stored between –20 and 30 °C) Battery life: Battery type and voltage:

LifeDop 100, 4-minute exams AA Alkaline 1.5V x3

Printer 500 prints Lithium-ion 3.7V

Audio bandwidth and power: Audio cable pin out:

245 Hz – 4 kHz, 0.33 W 3.5 mm stereo plug Tip - toward, Ring - away, Shaft – common Note: Common is not a ground connection

Printer Paper Type/Size (max): Printer Speed: Printer Resolution: Printer Impact Resistance: Printer Communication:

Thermal, 58 mm wide, 33 mm diameter 35 mm/sec, 8 seconds for standard printout 48 mm wide, 8 dots/mm, 384 dots/line 1.5 meter on linoleum floor RS232, 8 data bits, 1 stop bit, no parity, 115.2 Kbaud Input – 100-120 VAC, 29 VA, 50/60 Hz Output – 5 VDC, 2.3 A, center positive Auto scaled to max 4 kHz, 2 kHz and 1 kHz 25 mm/sec, 100 mm length w/ 4 sec of data 175 mm total with header

Printer Recharger: Waveform Frequency Scale: Waveform Time Scale: Printout Length:

Attention: Consult Accompanying Documents

MAN0007-DFU • Rev. A • 4/13

16

Wallach Surgical Devices

Transducer Model: LifeDop 5 MHz Bi-Dir Operating Mode: Continuous-Wave (cw) Application(s): Peripheral Vascular ACOUSTIC OUTPUT Global Maximum Value Pr.3 wo Associated fC Acoustic zsp Parameter Beam Dimensions EBD

MI (Mpa) (mW) (MHz) (cm) x-6 (cm) y-6 (cm) Az (cm) Ele. (cm)

0.05 0.12

ISPTA.3 (mW/cm2) 500

ISPPA.3 (W/cm2) 0.5

32.7 5.50 0.85 0.4 0.6 0.4 0.8

0.32.7 5.50 0.85 0.4 0.6

5.50 0.85

Transducer Model: LifeDop 8 MHz Bi-Dir Operating Mode: Continuous-Wave (cw) Application(s): Peripheral Vascular ACOUSTIC OUTPUT Global Maximum Value Pr.3 wo Associated fc Acoustic zsp Parameter Beam Dimensions EBD ISPTA.3 ISPPA.3 MI Pr.3 Wo fc zsp x-6, y-6 EBD

MI (Mpa) (mW) (MHz) (cm) x-6 (cm) y-6 (cm) Az (cm) Ele. (cm)

2

0.04 0.116

2

ISPTA.3 (mW/cm ) 365

ISPPA.3 (W/cm ) 0.37

15.7 8.43 0.63 0.42 0.14 0.6 0.3

15.7 8.43 0.63 0.42 0.14

8.43 0.63

the derated spatial-peak temporal-average intensity (mwatts per cm2). the derated spatial-peak pulse-average intensity (watts per cm2). the Mechanical Index. the peak rarefactional pressure (megapascals) associated with the transmit pattern giving rise to the value reported for MI. the total time-average ultrasonic power (mwatts). the probe center frequency (MHz). the axial distance at which the reported parameter is measured (cm). are the –6dB beam dim. in the x-y plane where zsp is found (cm). the entrance beam dimensions (cm). These dimensions are the same as the dimensions of the transmit crystal.

Measurement Uncertainties:

Power: Pressure: Intensity (Ispta): Frequency:

+34, -42% +11, -16% +23, -26% ± 5%

Acoustic Output Parameters are measured in water. Derated values, denoted by the subscript “.3”, take into account a conservative level of attenuation that would be encountered in the human body. The derated intensity values (I.3) are obtained from water values of intensity (Iw) at a depth of z calculated by: I.3 = exp(-0.23*0.3*f*z)*Iw (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: Pr.3 = exp(-0.115*0.3*f*z)*pr (where pressure is given in megapascals) Additional Output Reporting Information for IEC 61157 8 MHz: Iob < 112 mW/cm2

Note that parameter Zsp in the probe reporting tables is the same parameter as Ip in IEC 61157. Operating Conditions: There are no user controls which affect the ultrasound output.

MAN0007-DFU • Rev. A • 4/13

17

Wallach Surgical Devices

ABI Glossary Guide ABI Index – (Ankle-Brachial Index) A vascular test used to assess lower extremity circulation. It is the ratio of ankle pressure to the highest of bilateral brachial pressures providing a guide to severity of PAD. 0.90 – 1.30 0.70 – 0.89 0.40 – 0.69 < 0.40

Normal Mild Moderate Severe [1]

Aneroid – An actuating pressure device, used for inflating cuffs for obtaining blood pressures in vascular studies. Arterial – Pertaining to arteries, or vessels that carry blood from the heart to tissues throughout the body. Atherosclerosis – A thickening, hardening, and loss of elasticity of the walls of blood vessels, especially arteries due to accumulation of lipid materials. Bi-Directional – Directional, pertaining to the ability to sense or move in two directions. In the case of Doppler probes, it is the ability to distinguish blood flow both toward and away from the transducer. Brachial Artery – Main artery of the arm, continuation of the axillary artery on the inside of the arm [2]. The brachial branches into two primary arteries of the forearm, namely the radial and ulna arteries.

Brachial Artery

Radial Artery

Ulna Artery

Calcification – Deposits of lime salts in the walls of arteries. Claudication – A severe pain in calf muscles occurring during walking but which subsides with rest, resulting from inadequate blood supply due to atherosclerosis or occlusion. Diastolic – Pertaining to diastole, the part of the heart cycle in which the heart is in a period of relaxation. Corresponding to minimum blood pressure. Hypertension – A condition in which the patient has a higher blood pressure than that judged to be normal. Hyperlipidemia – An elevation of lipids, or fats, in the bloodstream including cholesterol, phospholipids and triglycerides.

MAN0007-DFU • Rev. A • 4/13

18

Wallach Surgical Devices