Samsung S-Patch3 User manual

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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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A. STATUS Bar
A.1. Elapsed Time: The elapsed time from the first signal receiving time
A.2. Device ID: Connected S-PATCH Device’s ID
A.3. BLE Connection Indicator: Bluetooth Low Energy Connection State
A.4. Device Battery Indicator: Remained battery state of the connected device
In the case of the ratio is lower than 25%, “Battery is too low”Notification will appear.

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In the case of the ratio is lower than 10%, “Change Device’s Battery!”Notification will
appear.
B. ECG View
Double Tapping on ECG View will toggle MONITORING and PAUSE mode.
In PAUSE mode, it’s enabled that Scrolling by swipe gesture on ECG Graph. Scaling
(magnification ratio changing 50 ~ 150%, by 10%) by zooming gestures is able for both
modes.
B.1. Measured ECG Signal: Measured ECG signals
B.2. ECG Paper Scale: Scale of ECG Paper. It’s same as actual size in case of the
magnification ratio is 100%
B.3. Heart Rate: Current Measured Heart Rate and Maximum/Minimum HR
B.4. Respiratory Rate: Measured Respiratory Rate. The unit of the respiratory rate is BrPM
(Breath per minute). Actual range of the respiratory rate is from 9 BrPM to 30 BrPM. The
resolution is 0.96 BrPM.
** During measure the Respiratory Rate, minimize move.
B.5. PAUSE Indicator: PAUSE mode indicator. Even in PAUSE mode, received signal will
be stored.
B.6. Left-side Time: The elapsed time of the left-side signal
B.7. Right-side Time: The elapsed time of the right-side signal
B.8. Magnification Ratio: The magnification ratio of the ECG signal and ECG Paper. It’s
invisible in case of the ratio is 100%
C. Heart Rate Trend View: Heart rate trend graph for 1 Hour.
D. Menu Button: It’s translucent. Touching the button makes it opaque and show menu buttons.
Nothing selected until 3 seconds then it backs to translucent and menu buttons will be
disappeared.
D.1. Change Device: Device Select View will appear
D.2. Set MARK: add User event mark
D.3. Show/Hide STATUS Bar: show/hide STATUS Bar
서식 있음: 글꼴: (영어) Times New
Roman, (한글) 바탕체
서식 있음: 글꼴: (영어) Times New
Roman, (한글) 바탕체

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D.4. ECG View’s Background:
BLACK: black background, green signal
PAPER: ECG Paper background, black signal
D.5. Import from file: read signal data from stored file. S-PATCH format(*.sp) and MIT
BIH format(.hea/.dat, 16 format - only for exported by this app) can be loaded.
If there is no folder stored signal files, check your system options like below. In case of
Android OS, Internal Storage would be hidden.

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D.6. Export to file: Received Signal data automatically stored to device’s storage as
formatted .sp (S-PATCH format). This button makes MIT BIH format file. The file name is
automatically generated by based on the Device Number and the first connection time.
D.7. Show HRV View: shows HRV information view
D.8. Show/Hide HR Trend View: show/hide HR Trend View
HR Trend View shows HR trend and minimum/maximum HR for 1 Hour.

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E. HRV View: shows HRV information
E.1. Time Domain HRV
E.1.1. AVNN: mean of all the intervals in ms
E.1.2. SDNN: standard deviation all RRIs over the complete test duration in ms
E.1.3. SDANN: standard deviation of the 5 min means in ms
E.1.4. ASDNN: mean of the 5 min standard deviation in ms
E.1.5. NN50: the number of RRI difference of successive RRIs greater than 50ms
E.1.6. PNN50: NN50 as a percentage of all allowed RRIs
E.1.7. RMSSD: root mean square of successive differences in ms
E.1.8. TINN: triangular index interval is the baseline width of the distribution measured as
a base of a triangle approximating the RRI distribution
E.2. Frequency Domain HRV
E.2.1. VLF: very low frequency power (0.00333 Hz to 0.040 Hz)
E.2.2. LF: low frequency power (0.040 Hz to 0.150 Hz)
E.2.3. HF: high frequency power (0.150 Hz to 0.400 Hz)
** During measure the HRV, minimize move.

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F. Device Select View: scanning S-PATCH devices nearby and show IDs.
F.1. Devices: Scanned S-PATCH devices are shown. One of them is selected then
connection will be tried. The number in bracket after S-PATCH name is the
Device ID. RSSI is Received signal strength indication in a wireless environment,
in arbitrary units. It could be used to calculate distance of the S-PATCH and the
host device.
F.2. Nothing available: This will disconnect connected device and stay without any
connection
F.3. Cancel: This will back without any changes
F.4. App version: This shows App’s version

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G. Signal Viewer
G.1. File Name: Loaded File Name
G.2. Total Time Range: Stored total signal’s range
G.3. Left-side time of signal: Signal Viewer’s left side time
G.4. Right-side time of signal: Signal Viewer’s right side time
G.5. Near Signal Navigation: This shows signals of larger range than Signal Viewer. Swipe
gesture will scroll the time range.
G.6. Small Time Range Navigation: This supports specific time selection in small time
range by touch. If total time range is too small, this will disappear.
G.7. Total Time Range Navigation: This supports the selection of the Small Time Range
Navigation’s range on the total time range.
H. Viewer Menu Button
“BACK”button supports return of previous window as like as Android Device’s Cancel
button.
Other buttons are same as S-PATCH real-time signal display state.

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The app shows as Landscape orientation as following as device’s orientation.
3.4 How to Install S-PATCH3
3.4.1 Installing S-PATCH
1) Download the S-PATCH App from Google Play Store (Android KitKat or later). The
device must support Bluetooth Low Energy.
2) Install the downloaded file on user’s mobile device.
3) Insert battery to main body 1 of S-PATCH3.
4) Connect Electrodes to electrode connect hole in each side of S-PATCH3.
3.5 Precautions
1) The electrodes and coin battery are disposable. Please observe local laws for disposal of
electrodes and coin battery.
2) Please ensure user’s hands are clean and dry when handle the S-PATCH3
3) The body hair possibly causes contact problem which results a fault detection of
physiological data.
4) After using the device, wipe dust and other foreign substances using a dry cloth.
5) This product must not be disposed of with your other household waste. Instead, it is
your responsibility to dispose of your waste equipment by handing it over to a
designated collection point for the recycling of waste electrical and electronic

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equipment. The separate collection and recycling of your waste equipment at the
time of disposal will help to conserve natural resources and ensure that it is recycled
in a manner that protects human health and the environment. For more information
about where you can drop off your waste equipment for recycling, please contact
your local city office, your household waste disposal service or the shop where you
purchased the product.

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4. Using and Operating S-PATCH3
4.1 How to Use S-PATCH3
1) After connect the electrodes with S-PATCH3, peel the plastic on the backside of the
electrodes.
2) Attach the S-PATCH3 on recommended position as drawn.
3) Push the power button longer than 3 seconds.
4) Confirm that the LED is ON and OFF 3 times.