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Document Title:
Document No.: DS101-SDUS01-01303
Product Name: Electronic Stethoscope DS101
510(k) File Name: 003_Electronic Stethoscope DS101 User Manual
4. Intended Use
The Electronic Stethoscope DS101 is intended for the detection, amplification
and recording of sounds from the heart, lungs, anterior and posterior chest,
abdomen, neck, limbs, arteries, veins and other internal organs with selective
frequency ranges. And the stethoscope chest-piece is designed for use with
child, adolescent and adult patients. It is used for any subject undergoing a
physical examination and intended only for medical diagnostic purposes in
clinic or hospital.
5. Operator Profile
The Electronic Stethoscope DS101 is designed to be used by anyone who
wishes to listen to the sounds as described in the Intended Use section above.
The user manual provides complete information on how to operate the
Electronic Stethoscope DS101. Additional operating training is not proposed.
6. Patient Privacy
The privacy of patient health information may be protected by state, federal,
or international/foreign laws that regulate how such information can be used,
stored, transmitted, and disclosed. This system employs security features that
are compliant with HIPAA policies. Third party access may be prohibited to
such information without obtaining written authorization from the patient.
The user is fully responsible for understanding and following all laws that
regulate storage, transmission, and disclosure of any electronic patient data
through the use of software. If the user becomes unable to comply with a law
or restriction that applies to use and disclosure of such data, the user should
not proceed to collect or save such information.
This application may require entry of individually identifiable health
information in order to function. Records are stored and recalled through the
Electronic Stethoscope DS101 User Manual
Page:
9 of 50
Ver.:
A1
Date:
2017/8/26
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