User's Manual

User Manual
Document No.
UM-C-002-EN
Date of Revision
2020.10.30
Revision No.
0
Page 5 / 123
1. Product Introduction
It is a device that attaches electrodes to certain parts of the potential difference that occurs when myocardial
activity is transmitted to the body surface, which detects signals and uses radio signals to display this ECG
data. If you connect the App after turning on the power of the device, you can see the ECG signal through
the App. While device is running for 14 days, ECG records are stored in the device. After the use of the
device is completed for14 days, the record in the device is transmitted to the PC software through a
dedicated cable, and the final report is documented and printed through the analysis program of the PC
software.
1) Common Name: AT-Patch ECG Analysis System
2) Product Name (Model Name): AT-Patch ECG Analysis System (ATP-C130)
3) Manufacturer: ATsens Co.,Ltd.
4) Address: No.806, Point Town, 11 Gumi-ro, Bundang-gu, Seongnam-si, Gyeonggi-do, Korea
5) Contact: Tel. [phone] / Fax. [phone]
6) U.S Representative
A. Name: Mtech Group
B. Address: 7707 Fannin St. Ste 200 Houston, TX 77054
C. The person in charge: Dave Kim
D. E-mail: [e-mail]
1.1 Intended Purpose
This device is intended to measure, analyze, and report continuous electrocardiogram (ECG) information for
long-term monitoring (up to 14 days) by attaching to the skin surface. While continuously recording patient
ECG, ECG records are saved in the device. It is indicated for use on patients 18 years or older who may be
asymptomatic or who may suffer from transient symptoms such as palpitations, shortness of breath,
dizziness, light-headedness, fatigue, or anxiety. The final report is offered to clinicians or doctors on an
advisory basis only. Used by patients as prescribed by physician or medical personnel.
1.1.1 Target Treatment group
Patients 18 years or older who may be asymptomatic or who may suffer from transient symptoms such as
palpitations, shortness of breath, dizziness, light-headedness, fatigue, or anxiety.
1.1.2 Target User
physician or qualified medical personnel (ex. a doctor, clinical pathologist, etc.)