Operating Instructions - Jaken Medical...
Operating Instructions - Jaken Medical...
Operating Instructions - Jaken Medical...
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Intended Use<br />
WARNING: The Eclipse should not be connected to nonmedical<br />
equipment unless the non-medical equipment complies<br />
with IEC 601-1. In addition, the enclosure leakage current of<br />
non-medical equipment connected to the Eclipse should not be<br />
allowed to exceed 500µA in fault condition. To maintain a<br />
proper enclosure leakage current, provide additional protective<br />
earth grounding, use an additional isolating transformer or use<br />
a ßoating power supply.<br />
WARNING: The Eclipse and any non-medical equipment that<br />
it is connected to should not be allowed within the patientÕs<br />
vicinity, which extends 6 feet (1.83 m) beyond the perimeter of<br />
the bed, table or chair, and 7 1/2 feet (2.29 m) above the ßoor.<br />
WARNING: NEVER create a direct connection between an<br />
Eclipse and a PYRAMIS computer if the Eclipse is already<br />
connected to a patient.<br />
Under the supervision of a qualiÞed physician trained in the subject of ECG<br />
interpretation, the Eclipse 850 and Eclipse Plus can be used to record the<br />
electrical activity of the heart for the purpose of correlating the resultant<br />
waveforms with the health of the heart muscle tissue structures.<br />
This equipment produces a 12 lead (view) electrocardiogram which can be<br />
used as a Þrst step for assessment of patients with cardiac arrythmias,<br />
intraventricular conduction block, pre-excitation syndrome and ischemic heart<br />
disease. Records stored and used during the life of the patient can assist<br />
physicians in the diagnosis and natural history of heart related illnesses (such<br />
as coronary artery disease).<br />
With appropriate support equipment, the Eclipse 850 can also be used in the<br />
evaluation of exercise induced ischemia of the heart typically referred to as an<br />
exercise stress test. The resultant electrical activity of the heart can be recorded<br />
as a 12 lead and further analyzed for ischemic episodes.<br />
This equipment is not designed to produce a deÞnitive interpretation nor an<br />
exhaustive evaluation of the patientÕs heart but rather provide an effective<br />
beginning for evaluation of patients with heart abnormalities.<br />
Eclipse <strong>Operating</strong> <strong>Instructions</strong><br />
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