Important Information
Read the important information in this Instructions for use before using this device. Follow the
instructions for use for your safety and keep it for future reference.
Intended Purpose
This device is a non-invasive automatic blood pressure monitor. The intended purpose of this device is
described in this section.
This device is intended to measure brachial blood pressures (systole and diastole) and pulse
rate.
This device is intended to indicate the presence of irregular heartbeat (IHB) when detected
during a measurement.
The device is intended to be reusable: single patient multiple use or multiple patient multiple
use depending on the specific variant.
Intended User, Patient, and Use Environment
This device is only intended to be used by user on patients in environments described in this section.
The device is intended to be used by patients (self-measurement) or on a third person in a
home healthcare environment (such as general household use).
The device is intended to be operated by adult users with the vision and motor functions as well
as the literacy and basic educations capable of understanding the content of this instructions for
use and operating general household electrical appliances.
The intended patients are normotensive and hypertensive adults and adolescents (aged 12
years or older) of the general population.
Indication & Clinical Benefits
This device is suitable for use for the following conditions and clinical benefits described in this
section.
The device is intended to measure human brachial blood pressure non-invasively for monitoring
of the systolic and diastolic pressures, to support the diagnosis medical conditions or diseases
related to blood pressure, including:
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