Samsung Confidential
[5]
1.
Product Introduction
1.1.
Introduction
The S-PATCH Wearable health recording system is an electrocardiogram(ECG) recording system
designed to record, transfer and display ECG data collected from devices worn on adult patient’s
body. The system consists of a Sensor device, a Cradle, PC software, a Mobile app and associated
accessories (electrodes, coin battery, USB cable, installation USB flash drive). The Sensor device
records the ECG signals continuously from the patients. The recorded data is then transferred to
the physician’s Windows PC via the Cradle for cardiac rhythm interpretation. The patients can
monitor the Sensor device status via the Mobile app installed on their smartphone.
Product Name - Wearable Health Recording System
Model Name - S-PATCH
Manufacturer - SAMSUNG ELECTRONICS Co., Ltd.
1-1, Samsungjeonja-ro, Hwaseong-si, Gyeonggi-do, 18448 Korea
1.2.
Indications for Use & Intended Use
The S-PATCH Wearable health recording system is indicated for use on adult patients prescribed
by physicians as an ECG data recorder for cardiac rhythm interpretation.
The S-PATCH Wearable health recording system is intended to record, transfer and display the
single-channel electrocardiogram (ECG) data including heart rate and ECG signals. It allows
physicians to analyze the cardiac rhythm. The system is not intended for pediatric use.
1.3.
Contraindication
1)
Patients with artificial cardiac pacemaker, cardioverter defibrillator, or other
implantable electric devices.
2)
Pregnant or breast-feeding mothers
3)
A current sign or medical history of skin cancer, rash, skin disorder, keloid, and/or any
injury.
