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