Samsung S-PATCH User manual

Samsung Confidential [1]
USER MANUAL
Wearable Health Recording System
(MODEL: S-PATCH)
Caution: Federal law restricts this device to sale by or on the order of a physician.
Document No.: S-UM-01 (Rev. 0.3)
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
2020.01.20
Established by Manufacturer’s User Manual Policy
Rev.0.1
2020.01.28
Section 5.6, Updated specification of external device
connection
Rev.0.2
2020.02.07
Section 4.2, Deleted applied part description
Section 5.3, Updated BLE specification
Rev.0.3
2020.02.14
Section 8, Added FCC SDoC information

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Table of Contents
1. Product Introduction .....................................................................................................................................................5
1.1. Introduction...........................................................................................................................................................5
1.2. Indications for Use & Intended Use...........................................................................................................5
1.3. Contraindication..................................................................................................................................................5
2. Cautions ................................................................................................................................................................................6
2.1. General .....................................................................................................................................................................6
2.2. Safety.........................................................................................................................................................................6
2.3. Usage and Storage Conditions......................................................................................................................7
2.3.1. Conditions for Usage...........................................................................................................................7
2.3.2. Conditions for Storage........................................................................................................................7
2.3.3. Cleaning Condition...............................................................................................................................7
3. Warning.................................................................................................................................................................................7
4. Components and Installation of S-PATCH ...........................................................................................................7
4.1. Main Device Components...............................................................................................................................7
4.1.1. Sensor device..........................................................................................................................................7
4.1.2. Cradle..........................................................................................................................................................8
4.1.3. PC software ..............................................................................................................................................9
4.1.4. Mobile app.............................................................................................................................................10
4.2. Accessory Components.................................................................................................................................10
4.3. How to Start S-PATCH....................................................................................................................................11
4.3.1. Required Environment....................................................................................................................11
4.3.2. System Initialization.........................................................................................................................11
4.3.3. Sensor device Setup..........................................................................................................................14
4.4. Precautions .........................................................................................................................................................15
5. Using and Operating S-PATCH................................................................................................................................15
5.1. How to Use S-PATCH ......................................................................................................................................15
5.1.1. Attachment to the patient body and Power On..................................................................15
5.1.2. Connection to the Mobile app......................................................................................................16
5.1.3. Completion of recording ................................................................................................................19
5.1. Daily Usage..........................................................................................................................................................19
5.2. Data download and management............................................................................................................19
5.2.1. ECG Data Download and Display ...............................................................................................19
5.2.2. ECG Data Import and Export........................................................................................................20
5.3. Specifications.....................................................................................................................................................21
5.4. Error Message....................................................................................................................................................22
5.4.1. Device Disconnection.......................................................................................................................22
5.4.2. Abnormal Signal Detect..................................................................................................................22
5.4.3. Low Battery Mode.............................................................................................................................22
5.4.4. Low Remaining Recording Time................................................................................................22
5.5. Maintenance.......................................................................................................................................................23
5.6. Specification of External Device connection......................................................................................23
5.7. Heart Rate Algorithm.....................................................................................................................................24
6. Labels and Packaging..................................................................................................................................................25
6.1. Labels.....................................................................................................................................................................25
6.1.1. Label for Packaging...........................................................................................................................25
6.1.2. Label for the Sensor device...........................................................................................................25
6.1.3. Label for the Cradle...........................................................................................................................25
6.1.4. Descriptions of the visual symbols of the label..................................................................26
6.2. Packaging.............................................................................................................................................................26
7. Electromagnetic Environment ...............................................................................................................................27
7.1. Guidance and Manufacturer’s Declaration – Electromagnetic Emissions..........................27

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7.2. Guidance and Manufacturer’s Declaration – Electromagnetic Immunity ..........................27
7.3. Guidance and Manufacturer’s Declaration – Electromagnetic Immunity ..........................28
7.4. Recommended separation distances between portable and mobile RF
communications equipment and the S-PATCH..............................................................................................29
7.5. Immunity and Compliance Level.............................................................................................................29
8. FCC Compliance Statement......................................................................................................................................30
9. Expected Service Life time and Warranty ........................................................................................................31
9.1. Expected Service Life Time.........................................................................................................................31
9.2. Product Warranty............................................................................................................................................31
10. Company Name and Address..................................................................................................................................31

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1. Product Introduction
1.1. Introduction
The S-PATCH Wearable health recording system is an electrocardiogram(ECG) recording system
designed to record, transfer and display ECG data collected from devices worn on adult patient’s
body. The system consists of a Sensor device, a Cradle, PC software, a Mobile app and associated
accessories (electrodes, coin battery, USB cable, installation USB flash drive). The Sensor device
records the ECG signals continuously from the patients. The recorded data is then transferred to
the physician’s Windows PC via the Cradle for cardiac rhythm interpretation. The patients can
monitor the Sensor device status via the Mobile app installed on their smartphone.
Product Name - Wearable Health Recording System
Model Name - S-PATCH
Manufacturer - SAMSUNG ELECTRONICS Co., Ltd.
1-1, Samsungjeonja-ro, Hwaseong-si, Gyeonggi-do, 18448 Korea
1.2. Indications for Use & Intended Use
The S-PATCH Wearable health recording system is indicated for use on adult patients prescribed
by physicians as an ECG data recorder for cardiac rhythm interpretation.
The S-PATCH Wearable health recording system is intended to record, transfer and display the
single-channel electrocardiogram (ECG) data including heart rate and ECG signals. It allows
physicians to analyze the cardiac rhythm. The system is not intended for pediatric use.
1.3. Contraindication
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. 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.
11) the Keep the smart phone with you to check the Sensor device status.
If the S-PATCH has no remaining storage memory or the coin cell battery drains, the
Sensor device will not continue to collect your data.
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, and the
battery certified to IEC 60086-4 or UL1642 should be used.
5) DO NOT use during magnetic resonance imaging (MRI) or external defibrillation
procedures.
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.
9) Do NOT allow the cable to twist or bend.
10) Make sure that all electrodes are connected to the patient correctly before operation.
11) Conductive parts of electrodes and associated connectors for type CF applied parts,
should not contact other conductive parts including earth;
12) Do not wear device over excessive body hair in the torso area. Excessive body hair
should be removed several hours before use.
13) Do not use any lotions, oils, or powders on your chest area before or during use.
14) S-PATCH is intended to be used with FDA cleared silver/silver chloride (Ag/AgCl) ECG
electrodes supplied to a patient by a physician or recording center. ECG electrodes not
FDA cleared may cause a patient’s skin to react with irritation or reddening.

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①
2.3. Usage and Storage Conditions
2.3.1. Conditions for Usage
1) Temperature: 5℃- 40℃(41℉to 104℉)
2) Relative humidity: 10%-95% (non-condensing)
3) Atmospheric pressure: 700hPa-1060hPa
2.3.2. Conditions for Storage
1) Temperature: −25℃- 70℃(-13°F to 158°F)
2) Relative humidity: 10% to 95% (non-condensing)
3) Atmospheric pressure: 700hPa-1060hPa
4) Keep the device in the case when it doesn't use.
2.3.3. 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
3. Warning
MR-unsafe!
Do not expose the device to a magnetic resonance (MR) environment.
1) The device may present a risk of projectile injury due to the presence of ferromagnetic
materials that can be attracted by the MR magnet core.
2) Thermal injury and burns may occur due to the metal components of the device that
can heat during MR scanning.
3) The device may generate artifacts in the MR image.
4. Components and Installation of S-PATCH
4.1. Main Device Components
4.1.1. Sensor device
<TOP>
①
②
③
⑤
④

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<BOTTOM>
Label
Name
Description
①
Battery module
Coin battery inset module
②
Sensing module
ECG Sensing module
③
Connect Cable
Connection between Battery module and Body2
④
Power Button
Power On/Off button
⑤
LED
LED Lamp to indicate the device states
⑥
Electrode connect hole
Holes for ECG electrodes connecting
⑦
Product code
Product Serial Number & QR code
⑧
Cradle connection pins
10-pins for connecting to Cradle
4.1.2. Cradle
Label
Name
Description
①
Module connection pins
10 pogo pins for connecting to S-Patch module
②
Push button
Locking door open button
③
Locking door
Locking door to fasten S-Patch module to the Cradle
④
USB cable
Micro type B USB Cable
⑤
LED
LED Lamp to indicate the cradle state
⑥
Ferrite core
Electromagnetic Interference blocking material
⑦
⑥
⑧
①
②
④
③
⑤
⑥

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②
;
Do not remove ⑥Ferrite core from the USB cable. It may cause EMI(Electromagnetic
Interference) problem
4.1.3. PC software
1) Login display
2) Main display
Label
Name
Description
①
Menu
File / Device / View / About
②
File Information
Recording Start Time : DD MM YYYY hh:mm
Duration : hh:mm:ss
Serial number : 8byte
Sampling Frequency : 256Hz
③
Symptom Marking
Input abnormal symptom time recorded by the
①
②
③
⑤
④
⑥

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Patient
④
ECG signal Graph
ECG signal graph chart display
- Zoom In/Out, Cursor, Marker
⑤
Analysis
Heart Rate Table
⑥
Heart Rate Graph
Heart rate graph chart display
4.1.4. Mobile app
[Device connection on] [Device connected]
Label
Name
Description
①
QR code scanning
QR code scanning to connect Bluetooth
②
Recording Time
Recording time among the total recordable time
③
Battery
Remaining battery level
④
Memory
Storage memory usage level
⑤
Lead on/off
Indication of module attachment on the patient body
⑥
Setting
Device disconnection, Alarm per each display item
4.2. Accessory Components
①
②
③
④
⑤
⑥

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<Electrode>
<Battery>
Label
Name
Description
①
Electrode
Multi-purpose recording electrodes with sticky gel feature
(high performance adhesive and foam backing)
Note: Use the FDA registered Electrode.
②
Battery
Power supply for S-PATCH. DC 3V Coin Battery.
Note: Use the certified battery by IEC 60086-4 or
UL1642
4.3. How to Start S-PATCH
4.3.1. Required Environment
oWindows 10 installed PC
-200MB free disk space or greater
-Minimum High Speed USB 2.0
oPC software
-Installation file (USB flash drive)
oSensor device
oCradle and USB cable
4.3.2. System Initialization
1) PC software installation
oInstall setup file (S-Patch PC software setup.exe) on the USB flash drive
oOpen the Spatch Management.exe

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2) Connect the Cradle to the PC USB Port. Then the LED of the Cradle will turn red color
3) Plug the Sensor device into the Cradle
oOpen the sliding door on the bottom of the Sensing module to connect the Cradle
oAttach the Sensing module to the Cradle. Then the LED of the Cradle will turn green
color
4) Execute S-PATCH management (S-PATCH.exe) in the Desktop or PC software installed folder
5) Create User account

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oUser name: Admin
oPassword: (Password provided separately in the packing box)
oThe following menu will appear. Create new account and click ‘Add’ and close
window. Make sure that password should contain 8 to 15 characters, at least one
upper case letter, at least one lower case letter and at least one special case
characters.
6) Login with new ID & Password
7) Click ‘Device-Connect’ in the Menu
8) Device-Initialize will be activated in the Menu and Click ‘Initialize’
oEnter Serial number printed in Packing box or Sensor device’s bottom side
oSetup the maximum recording time (default time is 72 hours)
oSetup the Start time (default time is set by current time in user PC)
oAfter completing initial setting, click ‘Save”
9) Click ‘Device-Disconnect’ in the Menu

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4.3.3. Sensor device Setup
1) Insert battery to the battery module of Sensor device
First, release the screw on the battery module using screw driver.
Second, open the upper case of battery module and insert the battery.
Lastly, close the case and lock the screw.
;
Do not replace the battery at extreme environment condition (Extremely high
temperature, high pressure, high humidity and Etc...).
Please contact to the manufacturer, if you need more information
to replace the battery.
The battery certified to IEC 60086-4 or UL1642 should be used.
2) Connect Electrodes to electrode connect hole in each side of the Sensor device

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4.4. Precautions
1) The electrodes and coin battery are disposable. Please observe local laws for
disposal of electrodes and coin battery.
2) To remove the battery if the Sensor device is not likely to be used for long time.
3) Please ensure user’s hands are clean and dry when handle the Sensor device
4) The body hair possibly causes contact problem which results a fault detection of
physiological data. Excessive body hair should be removed several hours before
use.
5) After using the device, wipe dust and other foreign substances using a dry cloth.
6) 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
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
where you purchased the product.
5. Using and Operating S-PATCH
5.1. How to Use S-PATCH
5.1.1. Attachment to the patient body and Power On
1) After connecting the electrodes with the Sensor device, peel the plastic on the backside
of the electrodes.
2) Attach the Sensor device on recommended position as drawn.
;
Make sure that all electrodes are connected to the patient correctly before operation.

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3) When press the power button, LED is On. And hold the power button until LED is Off.
5.1.2. Connection to the Mobile app
1) Copy the Mobile app (S-PATCH mobile app.apk) from the USB flash drive to the patient’s
smart phone.
2) Install the Mobile app (S-PATCH mobile app.apk) on the smart phone.
Sensing module
Battery module

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3) Execute the Mobile app.
4) QR code scanning on the packing box for Bluetooth paring
(If lose the box, refer to the QR code in the Sensor device bottom side.)
5) After completing paring, S-Patch Device Monitoring display will appear

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6) If adding S-PATCH widget in Home screen of mobile device, Recording Time / Battery /
Memory / Lead states will be monitoring in Home screen.
If the connection is interrupted due to an abnormal condition, Mobile app will display
“S-Patch is disconnected” and “S-Patch is not working”
S-PATCH Mobile app uses BLE and storage of the host device. And BLE needs Location

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Permission, so, BLE, Location and Storage permissions are requested. If it’s denied one
of them, the Mobile app could not receive the status data.
5.1.3. Completion of recording
When the recording time is over, remove the Sensor device from the patient’s chest and dispose
of the used electrodes
5.1. Daily Usage
Wear this S-PATCH as you go about your normal daily activities, as well as at night while you
sleep. However, you need to remove the Sensor device when:
-Showering, bathing, or swimming
-Traveling on aircraft
-Undergoing an MRI
1) To finish the Mobile app, press “BACK” button on the Android device or touch “Multi-
tasking” button on the Android device and close the app.
2) Remove the Sensor device from the chest.
3) When you are ready to put the Sensor device back on, attach the Sensor device on the
recommended position. Turn on the Mobile app and resume monitoring the Sensor
device status.
5.2. Data download and management
5.2.1. ECG Data Download and Display
1) Connect the Sensor device and Cradle to the Personal Computer
2) Open the PC software and Login with User name & Password created in the System
initialization step
3) Device connect and Read data in Menu bar
4) After reading data, ECG graph will appear in ECG signal graph window

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oECG Graph Preview
Navigation Button: Move recorded data along X-axis of time
oECG Graph
Zoom
-Mouse scroll: X/Y axis simultaneous zoom in/out
-Alt + mouse scroll: Y axis zoom in/out
-Ctrl + mouse scroll: X axis zoom in/out
-Shift + mouse left click area selection: selected area zoom in/out
-Zoom in limit area: X axis –1sec / Y axis –2mV
-Zoom out limit area: X axis –Full recorded time / Y axis –100mV
Cursor
-Create Cursor: Menu-View-Cursor
-Cursor1, 2 and difference will be displayed
Marker
-Place the mouse pointer over the graph and right click →‘Symptom Marking
Add’
-Create Marker entering Marker time name and time
-Created Markers will be displayed Symptom Marking window
5.2.2. ECG Data Import and Export
1) Export: To save a loaded ECG data including Markers. Following
2) Import: To load a stored EDF file and display ECG graph