i
Intended Use and Precautions
Intended Use
Precautions
Medical Wearable Platform SDK-01 is intended to record, store and transfer electrocardiogram (ECG) and accelerometer
data. The platform has the capability to provide Heart Rate, Respiratory Rate and R-R Interval using the ECG rhythm. The ECG recorder patch is an
ambulatory, continuous recording patch, intended for at-home or hospital, by clinicians or health professionals who intend to monitor their patient's
physiological and health conditions for an extended period of time. The device is not intended for patients under 18 years old and it is meant for a
single patient use
This Instructions for Use is only limited to the use of the hardware and the Software Development Kit (SDK). It does not include any information about
the mobile application or user interfacing device as that is outside the scope of the system.
5.
6. Do not use the patch with a cardiac pacemaker, defibrillators,
or other implanted electronic devices.
1. Any form of modification to this device is forbidden.
2. Do not use this device if it cannot stay in contact with the
skin and do not use on wounded or irritated skin.
3. This device is non-sterile.
4. The Continuous ECG Recorder is to be worn on chest.
2
Do not submerge the Patch in water. Patch may be removed
and be reapplied after showering or bathing
