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HINGMED ABP-03 - Hingmed ABPM Device Overview; Hingmed ABPM Scope of Application; Chapter 2 Safety Requirements; Device Intended Use

HINGMED ABP-03
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6
1.2 Brief Introduction of Hingmed ABPM
Blood Pressure Monitor with Body Position Information
Hingmed ambulatory blood pressure monitor has an outstanding feature that it could
provide the user's body position when taking blood pressure measurement, which is of
significance in clinical research. Some symptoms of hypertensive patients, such as
dizziness, nausea, brain death, are caused under dynamic environment of working or
other life. Therefore, monitoring patient’s blood pressure could not be confined to a quiet
condition. It is the best that patients who are wearing ambulatory blood pressure monitor
live a daily life and work. The data would reflect the actual daily blood pressure. That is
helpful to clinical judgments.
Different postures have a great influence on blood pressure. 24-hour monitoring shows
the blood pressure is fluctuant at distinct time. If a monitor can reflect the user's position
at the same time, it would be helpful for doctors to find the causes of the blood pressure
fluctuations, and then distinguish effectively natural change, fluctuation or fluctuation
caused by position changing and moving.
In addition, blood pressure data with position information can help doctors to make a
good judgment on orthostatic hypertension. Position hypertension is that the pressure is
high at standing or sitting posture, but normal at lying flat. Orthostatic hypertension
accounts for 4.2% in domestic hypertension patients and 10% in abroad report.
Orthostatic hypertension is characterized by that there is not hypertension in normal and
just being found occasionally or in physical examination. Diastolic pressure rising-up and
large fluctuation would represent in orthostatic hypertension and the individual could be
accompanied by serious palpitation, tiredness, sleep quickly etc. In blood examination,
the plasma rennin activity in orthostatic hypertension is higher than that of normal people,
even than that of general hypertension patient.
Scope of application
Hingmed Ambulatory blood pressure monitor is designed to assist in diagnosis. Doctor
could give advice to use this medical device by his or her judgment if patient is:
Hypertension;
Hypotension;
Borderline hypertensive (BH), renal inadequacy;
Control and evaluate the anti-hypertension efficacy, etc.
Chapter 2 Safety Requirements
2.1 Intended use
Blood pressure monitor of ABP-03 is mainly used to measure blood pressures, which
include systolic pressure, diastolic pressure and pulse rate, of patients in different setting
intervals within 24 hours (not applicable to children under 3 years), and the measurement
data can be transmitted by USB data wire for medical personnel’s reference and analysis
in hospital, It is for use on the order of a physician only.

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