Intended Use - Cardiac Science Burdick 8500 Product Safety Manual

Intended use

Under the supervision of a qualified physician trained in ECG
interpretation the Burdick 8300 electrocardiograph and Burdick
8500 electrocardiograph can be used to record the electrical
activity of the heart for the purpose of correlating the resultant
waveforms with the health of the heart muscle tissue structures.
This equipment produces a resting 12-lead electrocardiogram
which can be used as a first step for assessment of patients with
cardiac arrhythmias, intraventricular conduction block, pre-
excitation syndrome and ischemic heart disease. Records stored
and used during the life of the patient can assist physicians in the
diagnosis and natural history of heart related illnesses (such as
coronary artery disease).
This equipment is not designed to produce a definitive
interpretation nor exhaustive evaluation of the patient's heart but
rather provide an effective beginning for evaluation of patients
with heart abnormalities.
WARNING! Follow all instructions
You are responsible for the safety of your device. Please follow all
safety instructions.
70-01047-01 B
Intended use
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