Vascular Diagnostic System User Manual Newman Medical 5350 Vivian Street, Unit C Arvada. CO 80002 1-800-267-5549 info@newman-medical.com www.newman-medical.
COMMON TERMINOLOGY ABI – Ankle Brachial Index – the ratio of the ankle systolic blood pressure divided by the brachial (arm) systolic blood pressure. DP – (or DPA) -- Dorsalis Pedis Artery --- the artery on top of the foot. Used in the ABI exam. MHz – Megahertz – Millions of cycles per second --the frequency of the sound transmitted by a vascular probe is measured in megahertz - 8 million cycles per second, for example.
Contents Chapter 1 – About simpleABI ........................................................2 Chapter 2 – Safety .........................................................................2 Chapter 3 – Setting up your simpleABI .........................................3 Chapter 4 – simpleABI Reporting Software ...................................5 Chapter 5 – Performing Exams ......................................................6 Chapter 6 - Detailed Description...............................................
Chapter 1 – About simpleABI Congratulations on your purchase of a simpleABI System from Newman Medical. The simpleABI was designed to be the easiest and most intuitive system on the market for initial vascular assessment. We hope you find that to be the case. If not, please do not hesitate to call us and let us know how we can improve the product for you.
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: No independently confirmed adverse effects caused by exposure from present diagnostic ultrasound instruments have been reported in human patients in the absence of contrast agents.
Windows XP (32 or 64 bit) Windows 7 (32 or 64 bit) Do not install on any other operating systems prior to contacting Newman Medical Technical Support for information. WARNING: Use of other applications (word processing, games, internet) is not an appropriate use of a medical device and must be avoided to ensure proper operation of the simpleABI system. Software Installation Directions 1. Plug in included USB Flash Drive into PC 2. Copy *.msi to C:\ purchased) (.
18. Click ‘Install this driver software anyway’ on the Windows security window. This will begin the install for the driver for the PVR box. 19. Driver should be properly installed and can be checked by opening simpleABI Reporting Software and clicking on either PVR button on an opened ABI Report. If installed properly, pop-up window will display ‘Left/Right PVR Device Connected’ a.
Chapter 5 – Performing Exams ABI EXAMINATION Overview: The ABI has become the best known and standardized test for PAD. Fundamentally it is simply the systolic blood pressure taken with the cuff at the ankle divided by the systolic pressure with the cuff on the upper arm. Recent reviews1 and reimbursement criteria require that the measurements be done with a Doppler using both the DP and PT arteries at the foot. A PVR waveform is also required for reimbursement.
• Wrap appropriate cuffs at each site. Attach the hoses from the Cuff Link Control Box to each cuff as shown above. The green connectors go to the arm cuffs and yellow to the ankles. Brachial Pressure: Use the computer cursor and click on the site you would like to begin with, usually the right brachial. Place the Doppler probe at an angle to the skin over the radial artery. *HINT* Hold the probe close to the end. It also helps to rest your hand on the patient to keep the probe in place.
Press and hold Inflate on the Cuff Link remote and inflate the cuff until you no longer hear the signal, and continue for an additional 20 mmHg. Release the Inflate button and the cuff will automatically start to slowly deflate. When you hear the Doppler signal return press the Pressure button and it will be stored on the screen. Press the Dump button. Leg Pressures and waveforms: Press Next on the remote and the system will move to the Dorsalis Pedis (DP) site.
The Doppler probe and Cheater on the DP. The Doppler probe on the PT artery. Page 9 of 21 Draft 1.
To obtain a PVR waveform at the ankle cuff, press the button with the waveform image on it on the remote. The cuff will inflate to the proper pressure and hold that while the waveform is obtained. The patient should remain still during the measurement; the waveform will appear about ten seconds after the cuff is inflated. Press Dump after the waveform is obtained. Repeat the sequence for the other leg – press Next and the system will move to the left brachial location. When finished, save the report.
Interpretation of PVR waveforms Pulse Volume Recording (PVR) is used to measure the change in pressure in the cuff caused by the small changes in volume that occur with each pulse. The analysis of the waveform is based on the shape of the waveform rather than the amplitude. PVRs are not affected by calcified arterial walls and are relatively easy to perform.
Moderately Abnormal: Waveform starts to broaden and no reflected wave. (The first pulse may be an artifact but also may be an arrhythmia.) Moderate Abnormal Abnormal: No reflected wave, slow rise. The cuff must have been slowly losing pressure as well because of the downward slope. Page 12 of 21 Draft 1.
Abnormal: Slow rise, little reflected wave – quite a bit of tremor “noise” Determining site of occlusion with PVR waveforms:3 A normal waveform at a site indicates that there is not likely any occlusive disease above that cuff. Abnormal at thigh: Probably aorto-iliac disease Normal thigh but abnormal calf (below knee): occlusive disease in superficial femoral and/or popliteal segments.
Segmental Examination Purpose: A segmental exam of the leg is an extension of the ABI exam. In this test, you can attempt to localize the site of an occlusion by taking the pressures and waveforms at more locations on the leg. By observing the difference in pressure between adjacent sites on the leg you can tell if there is an occlusion between those sites. A greater than 20mmHg difference between sites is considered positive for a significant stenosis in the artery between or under the cuff.
Now press Next and place the Doppler probe on the posterior tibial (PT) artery behind the inside ankle bone. Obtain the pressure by again pressing Inflate, then Pressure when the sound returns, and then Dump. To obtain a PVR waveform at the ankle cuff, press the button with the waveform image on it on the remote. The cuff will inflate to the proper pressure and hold that while the waveform is obtained.
Pressures Place the PPG sensor on the index finger with the sensor on the fleshy part of the finger. Wait until you get consistent beeps from the system. (Double beats will not affect the measurement.) Select the brachial pressure box on the screen with the computer cursor. Press and hold Inflate on the Cuff Link remote and inflate the cuff until you no longer hear the signal, and continue for an additional 20 mmHg. Release the Inflate button and the cuff will automatically start to slowly deflate.
The DigiDop periodically checks the status of the batteries. When the power button LED flashes, the battery level is low and batteries should be charged immediately. Volume The DigiDop has multiple volume levels. These are adjusted by sliding the volume slider on the left hand side of the main unit. Recharge The simpleABI comes with a rechargeable DigiDop. Simply plug the AC adapter into the charging jack at the bottom of the DigiDop to begin charging unit.
Excess gel should be wiped off after each examination. Unit should be cleaned with a damp water or alcohol based wipe. Mild soap or detergent can be used. In particular pay attention to any surface openings on the unit including, but not limited to, the speaker grill, the battery compartment, the audio output, and the parting line between the front and back shell. Practitioners should wash hands and change gloves after every exam. hospital guidelines for cleaning and disinfection policies.
Transport/Storage Humidity Battery Voltage, type Battery Life 5%-90%, non-condensing 3 x 1.2 volts, AA NiMH 500, 1-minute exams PVR Box Dimensions-imperial (h x w x d) Weight Interface 2.75” x 2.0” x 0.8” 200 grams (8 ounces) USB, Type B Acoustic Properties (DigiDop) System: Transducer Model: DigiDop 5MHz Operating Mode: Continuous Wave (CW) Application(s): Peripheral Vascular Acoustic Output Global Maximum Value pr.
MI Mechanical Index. The value of MI at the position of ISPPA.3, (MI@ISPPA.3) may be reported instead of MI (global maximum value) if ISPPA.3 is ≤ 190W/cm2 . pr.3 derated peak rarefactional pressure (megapascals) associated with the transmit pattern giving rise to the value reported under MI. Wo ultrasonic power (milliwatts). For the operating condition giving rise to ISPTA.3, Wo is the total time-average power; for the operating condition subject to reporting under ISPPA.
Chapter 10 – Resources, Service, & Support The simpleABI System and components are guaranteed to be free from defects in material and workmanship for 2 years from the original sale of the device. This guarantee includes all parts and labor required to repair or replace the unit, including shipping the unit back to the customer. Customer is responsible for the adequate packaging and return of the unit for servicing.
