Samsung Confidential
[5]
1.
Product Introduction
1.1
Introducing S-PATCH3
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 body signal sensing module, ECG electrodes
and mobile app viewer to monitor the signals.
•
Product Type–
Ambulatory electrocardiographic systems
•
Name– S-PATCH3 Wearable Health Monitoring System
•
Serial Number– SP3-1612-0041
•
Manufacturer–
SAMSUNG ELECTRONICS Co., Ltd.
1-1, Samsungjeonja-ro, Hwaseong-si, Gyeonggi-do, 18448 Korea
1.2
Indication for Use
The S-PATCH3 Wearable Health Monitoring System is intended to record, transfer and store single
channel electrocardiogram signals. The S-PATCH3 signal sensing module transmits data through
wireless communication to mobile device. The product is not intended for pediatric use.
The S-PATCH3 wearable health monitoring system monitors and displays:
•
Heart Rate
•
ECG signal
•
Heart Rate Variability
•
Respiration Rate
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.
2.2
Safety
1)
Before treatment, 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.
5)
DO NOT use during magnetic resonance imaging (MRI) or external defibrillation
procedures.
