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DESCRIPTION
CorX –
The CorX is a class IIa medical device that satisfies the electrical safety requirements required by
international standards.
The CorX is designed to perform exams with one derivation ECG, with a particularly fast procedure, which
uses a graphical interface controllable tablet or smartphone.
This procedure records and collects all the information from while performs the data entry with personal
data of the patient.
The CorX is a lightweight, portable health monitor for use in the home by lay-users. Instead of a customary
box type unit, the CorX has been design as a wearable device in the form of a watch that can be used as a
normal smartwatch (including social media notification, email notification, message notification) for
measuring, displaying, reviewing and storing of multiple physiological parameters including ECG, heart rate,
pulse oxygen saturation (SpO2), pulse rate, and monitor the physical activity by a pedometer and motion
sensor. The proposed device, CorX, used is for spot checking of ECG, HR, SpO2, and PR in adult patients.
This device is not intended to substitute for a hospital diagnostic ECG device or hospital pulse oxygen
saturation.
The device is intended to be used in a home setting that is worn on the wrist as a watch that connects to an
“app” on a smartdevice that can provide further functionality. The CorX is a watch that can display multiple
physiological parameters including:
•
ECG recording including QRS detection, VEB detection, and heart rate
•
Functional pulse oxygen saturation (SpO2) by percent of saturation including pulse rate
Sensors and electrodes are contained in the housing of the watch that converts the information to
electronic signals that are processed by the software to display different parameters. Measurement and
recording of these parameters are stored in the watch that can be synced with the “app” on a smartdevice
such as the user’s phone. Information can then be reviewed as recorded by the watch and may also be
transmitted through a “portal” for accessing information over the internet. This information can be viewed
by a healthcare professional to see current or historical health information for a patient allowing more
interaction to occur with the healthcare professional and patient.
Functionality of the device is integrated firmware and PCB contained in a housing that is slightly larger than
a conventional watch with an adjustable band. The Saluber CorX is made from flexible plastic material that
are common in other household and wearable products to provide comfort and flexibility to the user, e.g.
similar to a Fitbit™ or Garmin® wearable device. A rechargeable lithium battery is contained in the device
that can be charged through a standard USB 2.0/3.0 port. The smartwatch must not be charged while
being worn; when the smartwatch is charging it goes into a particular state that is not available for use.
The charge for continuous use is over many hours compared to intermittent use can be maintained for
many days as the power consumption depends on use of physiological parameter monitoring.
The device does not contain alarms and is not to be used in emergency situations. Notifications and user
programmable settings can be made which are indicated for personal health information. The device is not
intended to be life-supporting or life-sustaining. The device is reusable by the patient and is non-sterile.
