Intended Use/Indications for Use
5-2
Specifications and Regulatory
Intended Use/Indications for Use
The Model 3810A is intended to be used upon prescription of a licensed
physician or authorized healthcare provider by patients as a means to
automatically collect and transmit medical information, such as weight,
blood pressure, and non-diagnostic ECG, over normal residential
telephone lines, between a patient, typically at home, and a healthcare
professional at the authorized provider.
Indications
for Use
The M3810A is indicated for patients at home, who are capable and
willing to self-administrate this device, upon prescription of their
healthcare provider, to collect and transmit medical information, such as
weight, blood pressure (including pulse rate) and non-diagnostic ECG
rhythm strip to the healthcare provider at another location. The patient
takes these measurements, typically once per day, and the information is
transmitted automatically via normal telephone time to the healthcare
provider. The device does not send any real-time alarms. Clinical
judgement and experiences are required to check and interpret the
information delivered.
Contra-
indications
The device is not intended as a substitute for medical care. The device is
contra indicated for patients with uncompensated heart failure, patients
at high risk of life threatening arrhythmias, patients with recent
myocardial infarctions, or patients requiring direct medical supervision
or emergency interventions.
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