[5]
1.
Product Introduction
1.1
Introducing S-PATCH3-CARDIO
This product is intended to measure, transfer and record electrocardiogram signal. The viewer on
mobile device may display ECG wave form, Heart Rate, Respiration Rate, Heart Rate Variability and
other information. The product consists of S-PATCH3-CARDIO body signal sensing module, ECG
electrodes and mobile app viewer to monitor the signals.
•
Product Name–
Wearable health Monitoring System
•
Model Name– S-PATCH3-CARDIO
•
Manufacturer–
SAMSUNG SDS Co., Ltd.
1.2
Indication for Use
This product is intended to measure, transfer and record electrocardiogram signal. The viewer on
mobile device may display ECG wave form, Heart Rate and other information. The product consists
of S-PATCH3-CARDIO body signal sensing module, mobile application and web portal of
electrocardiogram analysis for physician.
The S-PATCH3-CARDIO signal sensing module transmits data through wireless communication to
mobile device.
The S-PATCH3-CARDIO wearable health monitoring system monitors and displays:
-
Heart Rate
-
ECG signal
-
The connection between S-PATCH3-CARDIO and mobile device is using Bluetooth
communication.
2.
Cautions
2.1
General
1)
DO NOT store in extremely hot, cold, humid, or wet conditions.
2)
Since this product is a medical device, instructions are required to properly dispose
of it. Contact the deputy or manufacturer for such instructions. Improper disposing of
this device can lead to legal consequences.
3)
Contact the manufacturer if the product functions abnormally, problematically, or not
at all. Any attempt to repair without the manufacturer’s guide is not recommended.
4)
Reuse of the electrodes is prohibited in any circumstances due to the infection.
5)
Use of electrodes sticker may cause a skin irritation or reaction.
6)
DO NOT expose to strong electromagnetic fields.
7)
Too much body hair may cause an unsuccessful recording.
8)
DO NOT use to diagnose heart related conditions.
9)
No warranty for any data or information that is collected erroneously by the device,
or misuse or malfunction as a result of abuse, accidents, alteration, misuse, neglect,
or failure to maintain the products as instructed.
10)
If there is a change in the performance of a medical device, contact the manufacturer
for action.
2.2
Safety
1)
Before use, the doctor must explain cautions to the patient.
2)
Operate the product in the correct order as described in this manual.
3)
Use this device under doctor’s prescription.
4)
Beware of the polarity of the Coin battery when exchange and insert the battery.
