Product Manual

Page 2 of 21
Draft 1.1
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.
What’s new in the simpleABI System
Simple and intuitive PC based interface
Direct to Computer reporting software for ease of reimbursement
Chapter 2 – Safety
Intended Use
The simpleABI System was designed to aid in the diagnosis of peripheral arterial disease (PAD)
through diagnostic exams including Ankle Brachial Index (ABI).
Caution: Federal law restricts this device to sale by or on the order of a physician or other licensed
practitioner.
Contraindications
Contraindications: Do not perform the ABI exam on someone suspected of having acute deep
venous thrombosis, and do not take an arm pressure in an arm with a shunt or dialysis graft.
Warning: The device is not to be used on or near the eyes.
Warning: The device is for use only on intact skin.
Warning: The device is not to be plugged into a telephone or modem system.
Safety of the Blood pressure cuffs
Inspect the cuffs for damage periodically. Do not leave a cuff inflated at high pressures for an
extended period of time when on a patient. Do not inflate a cuff when it is not on a patient. Cuff
covers may be washed by removing the bladders. Any open lesion with the potential for
contamination should be covered with an impermeable dressing.
Safety of Dopplers
The simpleABI was designed according to National and International consensus safety standards.
Throughout design of this product, safety was the paramount concern. In view of that, this
product was designed according to the principle of ALARA (As Low As Reasonably Achievable).
AIUM Statements
As Low As Reasonably Achievable (ALARA) Principle
Approved March 16, 2008
The potential benefits and risks of each examination should be considered. The ALARA (As Low As
Reasonably Achievable) Principle should be observed when adjusting controls that affect the
acoustical output and by considering transducer dwell times. Further details on ALARA may be
found in the AIUM publication "Medical Ultrasound Safety."
Prudent Use and Clinical Safety
Approved March 19, 2007