Samsung S-Patch3 Manual de usuario
Samsung Confidential
[1]
USER MANUAL
Wearable Health Monitoring System
(MODEL : S-PATCH3)
Document No. : S-UM-01 (Rev. 0.2)
Samsung Electronics Co., Ltd.
1-1, Samsungjeonja-ro, Hwaseong-si, Gyeonggi-do, South Korea
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Revision History
Revision
Number
Issue Date
Contents of revision
Rev.0.0
2016.12.28
Established by Manufacturer’s User Manual Policy
Rev.0.1
2017.1.5
5.1 Label Update
Rev.0.2
2017.2.9
5.1 Label Update
Rev.0.2
2017.2.9
4.2.1 Spec Update
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Contents
1. Product Introduction....................................................................................................................................5
1.1 Introducing S-PATCH3.........................................................................................................................5
1.2 Indication for Use ....................................................................................................................................5
2. Cautions .............................................................................................................................................................5
2.1 General........................................................................................................................................................5
2.2 Safety............................................................................................................................................................5
2.3 Contra-Indication....................................................................................................................................6
2.4 Usage and Storage Conditions.............................................................................................................7
2.4.1 Conditions for Usage........................................................................................................................7
2.4.2 Conditions for Storage......................................................................................................................7
2.4.3 Cleaning Condition ...........................................................................................................................7
3. Components and Installation of S-PATCH3..........................................................................................8
3.1 Main Device Components .....................................................................................................................8
3.2 Accessory Components ..........................................................................................................................9
3.3 Display viewer........................................................................................................................................ 10
3.4 How to Install S-PATCH3.................................................................................................................. 18
3.4.1 Installing S-PATCH....................................................................................................................... 18
3.5 Precautions.............................................................................................................................................. 18
4. Using and Operating S-PATCH3............................................................................................................ 20
4.1 How to Use S-PATCH3....................................................................................................................... 20
4.2 Specifications.......................................................................................................................................... 25
4.2.1 S-PATCH3 Specifications............................................................................................................ 25
4.3 Error Message and Alarm................................................................................................................. 26
4.3.1 Device Disconnection.................................................................................................................... 26
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4.3.2 Abnormal signal detect.................................................................................................................. 26
4.3.3 Low Battery mode.......................................................................................................................... 27
4.3.4 Low Remaining Storage................................................................................................................ 28
5. Labels and Packaging................................................................................................................................. 30
5.1 Labels........................................................................................................................................................ 30
5.1.1 Label for Packaging ....................................................................................................................... 30
5.1.2 Label for module............................................................................................................................. 30
5.2 Packaging................................................................................................................................................. 31
5.2.1 Package List..................................................................................................................................... 31
5.2.2 Package Units.................................................................................................................................. 32
6. Information on EMC ................................................................................................................................... 33
6.1 Guidance and Manufacturer’s Declaration – Electromagnetic Emissions........................ 33
6.2 Guidance and Manufacturer’s Declaration – Electromagnetic Immunity........................ 33
6.3 Guidance and Manufacturer’s Declaration – Electromagnetic Immunity........................ 34
6.4 Recommended separation distances between portable and mobile RF communications
equipment and the EUT.................................................................................................................................. 35
6.5 Immunity and Compliance Level.................................................................................................... 36
6.6 Guidance and Manufacturer’s Declaration – Electromagnetic Immunity........................ 37
7. FCC Compliance Statement..................................................................................................................... 38
8. Product Life time and Warranty ............................................................................................................ 38
8.1 Product Life time.................................................................................................................................. 38
8.2 Product Warranty................................................................................................................................ 38
9. Company Introduction............................................................................................................................... 39
9.1 Company Name and Address ........................................................................................................... 39
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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.
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6) DO NOT drop or bump with excessive force.
7) DO keep components out of reach of children.
8) DO NOT swallow the device or wind the cable around the neck.
2.3 Contra-Indication
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.
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2.4 Usage and Storage Conditions
2.4.1 Conditions for Usage
1) Temperature: 0℃-45℃(32℉to 113℉)
2) Relative humidity: 10%-95%(non-condensing)
3) Atmospheric pressure: 700hPa-1060hPa
2.4.2 Conditions for Storage
1) Temperature: −20℃-70℃(-4℉to 158℉)
2) Relative humidity: 10%-95%( non-condensing)
3) Atmospheric pressure: 400hPa-1500hPa
4) Keep the device in the case when it doesn't use.
2.4.3 Cleaning Condition
1) Clean the device with soft, dry cloth
2) Equipment failure may occur due to dust and debris during long-term use of the
equipment.
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3. Components and Installation of S-PATCH3
3.1 Main Device Components
<S-PATCH3>
Label
Name
Description
1
Main Body1
Coin battery inset module
2
Main Body2
Main PCB module
3
Connect Cable
Cable between two main bodies
4
Power Button
Power On/Off button
5
LED
LED Lamp to indicate the states
6
Electrode connect hole
Holes for ECG electrodes connecting
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3.2 Accessory Components
<Electrode>
<Battery>
Label
Name
Description
1
Electrode
Multi-purpose monitoring electrodes with sticky gel
feature (high performance adhesive and foam backing)
Note: Use the FDAregistered Electrode.
2
Battery
Power supply for S-PATCH3. DC 3V Coin Battery.
TheApplied Parts are main device and electrode
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3.3 Display viewer
1) Main Display of S-PATCH3 App
서식 있음: 글꼴: (영어) 바탕, (한글)
바탕, 11 pt
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