450CL Advanced- Single Level + Exercise Vascular System

THE advanced vascular system.

ABI-450CL Advanced Single Level + Exercise

Automated System for single level, multi-level, and single level with exercise studies.

Newman Medical’s PC based simpleABI systems are designed to quickly and easily produce the results you need for the diagnosis of lower extremity peripheral artery disease. These systems not only save time in the exam but their simplicity reduces staff training and re-training time. They produce accurate full page reports with the documentation needed for reimbursement.

simpleABI systems lead you through the exam by observing the report coming together on the large computer screen – no need to memorize complex menus or protocols. Since the report is created on the computer, no secondary downloading steps are necessary for storing, printing, or sharing the results.

Cuff-Link Main Control

The Cuff-Link main control unit is, quite simply, an integrated speed machine. The simpleABI 450CL integrates:

• An 4-port cuff selector (8-port shown)
• Interchangeable Doppler probes
• Pressure sensors
• A pump
• Control software

All of that integration makes exams easier and faster to perform while also reducing costly errors.

Cuff-link Remote

The Cuff-link remote allows the user to step through the exam with remote push-button simplicity.

• Easily move between sites
• Large, easy to read display of the current cuff pressure.
• Push button inflation
• Automated cuff deflation insures accurate pressures.
• One button waveform creation

Software

Powerful yet simpleABI 450CL software saves you time and is what sets the simpleABI systems apart. The software is an integrated part of the system; no separate downloading of the data is needed.

• Automatic index calculations, avoiding potential errors
• Automatically stores each exam with time stamp
• Your logo and contact information can be shown on the report
• Your physicians, operators and interpreters can be on drop-down editable menus
• Drop down ICD-10 codes
• Suggested CPT codes and interpretation of results are shown
• Multiple and selectable formats to store the reports: PDF, TIFF, CSV, BMP, JPG
• DICOM software is available as an option

Reports

The 450CL software provides a complete set of tests and reports for lower extremity arterial evaluation. The tests that can be done with the simpleABI 450CL include:

• Single Level Exams – Single level exams for diagnosing obstruction. Can be done using Doppler or PPG as pressure sensor. Meets equipment requirements for CPT code 93922.
  • ABI (Ankle Brachial Index) – with dual ankle Doppler pressures and PVR waveforms. This is the fundamental PAD exam.
  • ABI with Toe (Ankle Brachial Index + Toe or TBI) – with dual ankle Doppler pressures and PVR waveforms. PPG or Doppler can be used on toes. Typically used if the patient has calcified vessels the ABI cannot be obtained.
• ABI Exercise Exams – Vascular exercise exams. Useful for pseudo claudication if the patient has PAD symptoms but the resting ABI is normal or questionable.
  • ABI with Exercise – Single level exam performed pre and post exercise. Can be done with provocative maneuvers or treadmill protocol. Meets requirements for CPT code 93923.
  • ABI Stress with Treadmill – Single level exam performed pre and post exercise. When used with the specified treadmill protocol meets equipment requirements for CPT code 93924.

Doppler

The Cuff-link includes a built-in Doppler using Newman Medical’s sensitive, interchangeable probes. Cuff-link Dopplers have the sensitivity and audio response to allow you to hear the blood flow sounds quickly and clearly.

Our unique magnetic probe holder won’t crack or break and gently cradles the probe when not being used. The open design avoids gathering dirt, gel and germs.

The Cuff-link speaker is a powerful high fidelity speaker that has an extraordinarily smooth and rich response over the whole range of Doppler sounds.

Vascular sensors

All Cuff-link vascular probes provide the sensitivity and reliability you need. All probes will work on all Cuff-links for maximum versatility.   Our 5 and 8 MHz vascular probes have a smooth contour design that is comfortable to hold, comfortable for the patient, and easy to clean.

• 5 MHz probes provide excellent deep penetration for deeper arteries like the femoral, popliteal and brachial, and for deep veins
• 8 MHz probes are especially sensitive for vessels near the surface like the radial, posterior tibial, and dorsalis pedis arteries.
• Audio PPG probe. The DigiDop family of vascular probes also includes a unique PPG probe that generates audible sounds with each pulse. It is an excellent addition for obtaining pulses in the digits to assist in toe-brachial index or penile index measurements.
• The simpleABI 450CL comes with 8 MHz and PPG probes; the 5 MHz is optional.

Cuffs

The simpleABI 450CL system comes with a complete set of specialized vascular cuffs. They are a washable soft material over a non-latex bladder. The cuffs are long enough to completely encircle the limb. The set includes:

• 2 x 10cm
• 2 x 12cm
• 1 x 1.9cm digit cuff

Made in the USA

Our products are designed and manufactured near Denver Colorado, a long-time center for diagnostic ultrasound products. Each product, including each probe, is individually inspected and tested to assure quality and durability. We have a very experienced team that has been in the vascular business for many years.

The 450CL software provides a complete set of tests and reports for lower extremity arterial evaluation. The tests that can be done with the simpleABI 450CL include:

• Single Level Exams – Single level exams for diagnosing obstruction. Can be done using Doppler or PPG as pressure sensor. Meets equipment requirements for CPT code 93922.
  • ABI (Ankle Brachial Index) – with dual ankle Doppler pressures and PVR waveforms. This is the fundamental PAD exam.
  • ABI with Toe (Ankle Brachial Index + Toe or TBI) – with dual ankle Doppler pressures and PVR waveforms. PPG or Doppler can be used on toes. Typically used if the patient has calcified vessels the ABI cannot be obtained.
• ABI Exercise Exams – Vascular exercise exams. Useful for pseudo claudication if the patient has PAD symptoms but the resting ABI is normal or questionable.
  • ABI with Exercise – Single level exam performed pre and post exercise. Can be done with provocative maneuvers or treadmill protocol. Meets requirements for CPT code 93923.
  • ABI Stress with Treadmill – Single level exam performed pre and post exercise. When used with the specified treadmill protocol meets equipment requirements for CPT code 93924.

The simpleABI 450CL system comes with a complete set of specialized vascular cuffs. They are a washable soft material over a non-latex bladder. The cuffs are long enough to completely encircle the limb. The set includes:

• 2 x 10cm
• 2 x 12cm
• 1 x 1.9cm digit cuff

Industry Leading Two Year Warranty

All simpleABI Systems come with a 2 year warranty. The warranty includes both parts and labor and covers the Cuff-link box, the probes and cords. We can offer this outstanding warranty because our design and materials reduce the number and cost of warranty issues.

Computer (optional)

The computer currently supplied as an optional component of the simpleABI system is a robust netbook computer.

• Operating system: Windows 10
• 11.6 inch diagonal screen
• 4 GB memory
• 500 GB HDD
• Wireless/Bluetooth capability
• 6 to 8 hour battery

These specifications are subject to change as computers change rapidly.

The Newman Medical software will already be loaded on the computer.

Stand (optional – pictured with equipment)

The optional sturdy steel rolling stand for the simpleABI systems includes:

• A wide five legged anti-tip base
• A mounting plate for the computer and Cuff-link
• Hooks on the mounting plate for storing the hoses
• A basket for storing cuffs, gel, etc.

Literature:

 simpleABI Systems Brochure

 ABI-450CL Fact Sheet

 Reimbursement Information

Sample Reports:

 simpleABI sample ABI Report

 simpleABI sample ABI with Toe Report

 simpleABI sample ABI Stress Report

Quick Guides:

 Cuff-link ABI Exam Procedure

 Cuff-link TBI Exam Procedure

Level of Protection against electrical shock

Type B Applied Part; Class II Equipment

Designed to meet the following standards:

IEC60601-1, IEC60601-2, IEC60601-2-37