Samsung S-PATCH Wearable Health Recording System User Manual

  • Post last modified:April 30, 2023
  • Post category:Samsung

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Samsung S-PATCH Wearable Health Recording System User Manual

Samsung S-Patch featured img

Caution: Federal law restricts this device to sale by or on the order of a physician.

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

Product Introduction

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.,

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.

Contraindication:

  1. Patients with artificial cardiac pacemaker, cardioverter defibrillator, or other implantable electric
  2. Pregnant or breast-feeding mothers
  3. A current sign or medical history of skin cancer, rash, skin disorder, keloid, and/or any

Cautions

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 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.

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 ECG electrodes not FDA cleared may cause a patient’s skin to react with irritation or reddening.

Usage and Storage Conditions

  • Conditions for Usage
  1. Temperature: 5℃- 40℃(41℉ to 104℉)
  2. Relative humidity: 10%-95% (non-condensing)
  3. Atmospheric pressure: 700hPa-1060hPa
  • 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.

 

  • 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

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.

Components and Installation of S-PATCH

Main Device Components:

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

    Do not remove ⑥Ferrite core from the USB cable. It may cause EMI(Electromagnetic Interference) problem.

  • PC software:
  1. Login display: Samsung S-Patch img 4
  2. Main display: Samsung S-Patch img 5
    Label Name Description
    Menu File / Device / View / About
     

     

    File Information

    Recording Start Time : DD MM YYYY hh:mm Duration : hh:mm:ss

    Serial number : 8byte Sampling Frequency : 256Hz

    Symptom Marking Input abnormal symptom time recorded by the
      Patient
    ECG signal Graph ECG signal graph chart display

    – Zoom In/Out, Cursor, Marker

    Analysis Heart Rate Table
    Heart Rate Graph Heart rate graph chart display
  • Mobile app:

Samsung S-Patch img 6

Label Name Description
QR code scanning QR code scanning to connect Bluetooth
Recording Time Recording time among the total recordable time
Battery Remaining battery level
Memory Storage memory usage level
Lead on/off Indication of module attachment on the patient body
Setting Device disconnection, Alarm per each display item

 

Accessory Components:

Samsung S-Patch img 7

Label Name Description
 

 

Electrode

Multi-purpose recording electrodes with sticky gel feature (high performance adhesive and foam backing)

Note: Use the FDA registered Electrode.

 

 

Battery

Power supply for S-PATCH. DC 3V Coin Battery. Note: Use the certified battery by IEC 60086-4 or UL1642

 

How to Start S-PATCH:

Required Environment

  • Windows 10 installed PC

– 200MB free disk space or greater

– Minimum High Speed USB 2.0

  • PC software

– Installation file (USB flash drive)

  • Sensor device
  • Cradle and USB cable

System Initialization

  • PC software installation

– Install setup file (S-Patch PC software exe) on the USB flash drive

– Open the Spatch Management.exe

  • Connect the Cradle to the PC USB Then the LED of the Cradle will turn red color Samsung S-Patch img 8
  • Plug the Sensor device into the Cradle

– Open the sliding door on the bottom of the Sensing module to connect the Cradle Samsung S-Patch img 9

– Attach the Sensing module to the Cradle. Then the LED of the Cradle will turn green color Samsung S-Patch img 10

  • Execute S-PATCH management (S-PATCH.exe) in the Desktop or PC software installed folder
  • Create User account

– User name: Admin

– Password: (Password provided separately in the packing box)

– The following menu will 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. Samsung S-Patch img 11

  • Login with new ID & Password Samsung S-Patch img 12
  • Click ‘Device-Connect’ in the Menu 
  • Device-Initialize will be activated in the Menu and Click ‘Initialize’

– Enter Serial number printed in Packing box or Sensor device’s bottom side

– Setup the maximum recording time (default time is 72 hours)

– Setup the Start time (default time is set by current time in user PC)

– After completing initial setting, click ‘Save”

  • Click ‘Device-Disconnect’ in the Menu Samsung S-Patch img 13

Sensor device Setup

  • 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. Samsung S-Patch img 14

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.

  • Connect Electrodes to electrode connect hole in each side of the Sensor device: Samsung S-Patch img 15

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.

Using and Operating S-PATCH

How to Use S-PATCH:
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.

    Warning: Make sure that all electrodes are connected to the patient correctly before operation. Samsung S-Patch img 16

  3. When press the power button, LED is On. And hold the power button until LED is off.Samsung S-Patch img 17

Connection to the Mobile app:

  • Copy the Mobile app (S-PATCH mobile app.apk) from the USB flash drive to the patient’s smart phone.
  • Install the Mobile app (S-PATCH mobile app.apk) on the smart phone.
  • Execute the Mobile app. Samsung S-Patch img 18
  • 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.) Samsung S-Patch img 19
  • After completing paring, S-Patch Device Monitoring display will appear Samsung S-Patch img 20
  • If adding S-PATCH widget in Home screen of mobile device, Recording Time / Battery / Memory / Lead states will be monitoring in Home screen. Samsung S-Patch img 21If 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 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.

  • Completion of recording: When the recording time is over, remove the Sensor device from the patient’s chest and dispose of the used electrodes

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 theapp.
  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.

Data download and management:

  • 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 Samsung S-Patch img 22
  4. After reading data, ECG graph will appear in ECG signal graph window Samsung S-Patch img 23
  • ECG Graph Preview
    • Navigation Button: Move recorded data along X-axis of time
  • ECG 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 Samsung S-Patch img 24

ECG Data Import and Export:

  1. Export: To save a loaded ECG data including Markers. Following Samsung S-Patch img 26
  2. Import: To load a stored EDF file and display ECG graph Samsung S-Patch img 27

Specifications:

Classification Name Description
Performance Type CF-Type
Channel Single channel
 

 

Circuitry

Communication with mobile device Bluetooth
DC Offset Tolerance +/- 300mV
ADC Resolution 12 bits
ADC Sampling Rate 256 Samples/Second
Input Impedance >100 MΩ
Power Requirements Power Supply 3Vd.c. (Lithium coin battery)
Battery Life Up to 72 Hr.
 

Software

F/W version V1.00
CPU S1SBP6A (Cortex-M4F microprocessor)
BLE Dialog DA14583 (ARM Cortex-M0)
App(Android) Android version 9 or later
Physical Characteristics Weight (Exc. Battery) 8g
Dimension (Battery module,2) 29*5.5 (mm), 29*4.4 (mm) [D*H]
Dimension (Connect Cable) 110 ± 10 (mm)
 

Communication

Bluetooth Max. 10 Meters
Radio Modulation GFSK
Radio Frequency 2,402 MHz ~ 2,480 MHz
Max. RF Output Power 0 dBm

Error Message:

      • Device Disconnection:

If the BLE is disconnected on the mobile device, Mobile app will display “S-Patch is disconnected” message, Figure 1

      • Abnormal Signal Detect:

In case of Mobile app detects an invalid signal, assume LEAD OFF state and an error notification pop-up will appear, as shown below in Figure 2. Press “OK” to turn off the pop-up. After valid signal is detected, it’s changed to LEAD ON state.Samsung S-Patch img 28

  • Low Battery Mode:

If the battery level is less than 10%, you will get a notification that “Battery is too low”, Figure 3. Press OK to turn off notifications.

When the battery runs out, you will get a notification that “Change the Battery!”, Figure 4. Press OK to turn off notifications. And then you need to change the battery.

  • Low Remaining Recording Time:

When the recording time is finished, “Recording time is over, visit the hospital” notification will appear, as shown below in Figure 5. Samsung S-Patch img 29

Maintenance 

For cleaning, gently wipe with a soft dry cloth after using the Sensor device. Please attempt to keep the Sensor device dust free. The Sensor device is water resist. But it should be kept dry. This device does not have serviceable components. Do not disassemble, crush, puncture, short external contacts or circuits, dispose of in fire or water.

Specification of External Device connection

The Sensor device is connected to the Android Application. The data indicating the status of the device is transmitted to the application from the device.

(1) The required specification of the interface and IT -Network that combines PEMS

  • Sensor device / Mobile App interface
    • Data format: Bluetooth
    • Mobile Application: Application on based Android
    • Device status information
      • Device information (Bringing information when connecting to BLE)
      • Battery information (Receiving information periodically)

(2) Technical specification about network connection of PEMS including security features.

  • Mobile Application is designed to not-affect by an external virus infiltration. But if infected with virus, Operating System may be a loss of storage data. Therefore, in the case of virus infection it should be operated by an antivirus program.
  • Specification of Network connection: Communication protocol: the protocol between the Sensor device and the Mobile app is a BLE central (Mobile) – peripheral (Sensor device) communications and they communication with security requirements defined in the BLE Protocol Stack.

(3) Responsibility Organization

    • Connection of the PEMS to an IT-Network that includes other equipment could result in previously unidentified risks to patients, operators or third parties;
    • The responsible organization should identify, analyze, evaluate and control these risks;
    • Subsequent changes to the IT-Network could introduce new risks and require additional analysis; and
    • Changes to the IT-Network include:
      • changes in the IT-Network configuration;
      • connection of additional items to the IT-Network;
      • disconnecting items from the IT-Network;
      • update of equipment connected to the IT-Network; and
      • upgrade of equipment connected to the IT-Network.

Heart Rate Algorithm 

The ECG signals converted to the digital values after the analog front-end blocks. The digital signals are filtered to reduce the noise such as electrical motion, AC power noise (50/60 Hz), and motion artifacts. After enhancing the quality of the ECG signals, the R peaks in the QRS complex are detected and the interval (henceforth referred to as RRI) between every R peak is calculated in the Sensor device. The data are transmitted to the smart phone via BLE. In the host mobile application of the smart phone, the HR and HRV algorithms are estimated on data received from the Sensor devices. Samsung S-Patch img 30

The “RRI Estimation” block calculates differences between each pair of QRS indexes. Ectopic beats results in a sharp transient of R-R interval. The “Ectopic Beat Removal” block detects these abnormal beats and the values are replaced by the average value of adjacent R-R intervals.

Labels and Packaging

Labels:

Label for Packaging:Samsung S-Patch img 31

Label for the Sensor device: Samsung S-Patch img 32

Label for the Cradle: Samsung S-Patch img 33

Descriptions of the visual symbols of the label: Samsung S-Patch img 34

Packaging:

Identification

Components

Quantity

Main Box

Sensor device

1

Electrodes

4

Battery

1

Quick guide

1

Sub Box

Cradle

1

USB cable

1

USB flash drive

1

 

Electromagnetic Environment

Guidance and Manufacturer’s Declaration – Electromagnetic Emissions

– The S-PATCH is intended for use in the electromagnetic environment specified below. The customer or the user of the S-PATCH should assure that it is used in such an environment.

Immunity test

Compliance

Electromagnetic environment – Guidance

RF Emissions CISPR 11

Group 1

The S-PATCH uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.

RF Emissions CISPR 11

Class B

The S-PATCH is suitable for use in ail establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.

Guidance and Manufacturer’s Declaration – Electromagnetic Immunity

– The S-PATCH is intended for use in the electromagnetic environment specified below. The customer or the user of the S-PATCH should assure that it is used in such an environment.

Immunity test

IEC 60601 Test level

Compliance level

Electromagnetic environment – Guidance

Electrostatic discharge (ESD) IEC 61000-4-2

±8kV Contact

±2,4,8,15 kV air

±8kV Contact

±2,4,8,15 kV air

Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.

Guidance and Manufacturer’s Declaration – Electromagnetic Immunity

– The S-PATCH is intended for use in the electromagnetic environment specified below. The customer or the user of the S-PATCH should assure that it is used in such an environment.

Immunity test

IEC 60601 Test level

Compliance level

Electromagnetic environment – Guidance

Radiated RF IEC 61000-4-3

10 V/m

80 MHz – 2,7

GHz

80 % AM at 1

kHz

10 V/m

80 MHz – 2,7

GHz

80 % AM at 1

kHz

Portable and mobile RF communications equipment should be used no closer to any part of the S-PATCH, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.

Recommended separation distance

d = 1.166√𝑝  150kHz to 80MHz d = 1.166√𝑝 80MHz to 800MHz d = 2.333√𝑝  800MHz to 2.5GHz

where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m).

Field strengths from fixed RF transmitters, as deter-mined by an electromagnetic site survey, a

should be less than the compliance level in each frequency range. b

Interference may occur in the vicinity of equipment marked with the following symbol : Samsung S-Patch img 35

NOTE 1) At 80MHz and 800MHz, the higher frequency range applies.

NOTE 2) These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the S-PATCH is used exceeds the applicable RF compliance level above, the S-PATCH should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the S-PATCH.

b Over the frequency range 150kHz to 80MHz, field strengths should be less than [V1] V/m.

Recommended separation distances between portable and mobile RF communications equipment and the S-PATCH

– There is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the S-PATCH can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the S-PATCH as recommended below, according to the maximum output power of the communications equipment.

 

Rated maximum output power of transmitter [W]

Separation distance according to frequency of transmitter [m]

150kHz to 80MHz 80MHz to 800MHz 800MHz to 2.5GHz
V1=3Vrms E1=3V/m E1=3V/m
0.01 0.116 0.1166 0.2333
0.1 0.368 0.3687 0.7378
1 1.166 1.1660 2.3333
10 3.687 3.6872 7.3785
100 11.660 11.6600 23.333
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where p is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.

NOTE 1) At 80MHz and 800MHz, the separation distance for the higher frequency range applies.

NOTE 2) These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

 

Immunity and Compliance Level

Immunity test

IEC 60601 Test Level

Actual Immunity Level

Compliance Level

Radiated RF IEC 61000-4-3

10V/m

80MHz – 2.7GHz

80 % AM at 1 kHz

 

10V/m

 

10V/m

FCC Compliance Statement

 This device complies with part 15 of the FCC rules. Operation is subject to the following two conditions:

  • This device may not cause harmful interference, and
  • This device must accept any interference received, including interference that may cause undesired operation.

This equipment has been tested and found to comply with the limits for a Class B digital device pursuant to part 15 of the FCC rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment on and off, the user is encouraged to try to correct the interference by one or more of the following measures:

  • Reorient or relocate the receiving antennae
  • Increase the separation between the equipment and the receiver
  • Connect the equipment into an outlet on a circuit different from that to which the receiver is connected.
  • Consult the dealer or an experienced radio/TV technician for help.

FCC RF Exposure Statement:

This equipment complies with FCC radiation exposure limits set forth for an uncontrolled environment. End users must follow the specific operating instructions for satisfying RF exposure compliance. The antenna used for this transmitter must not transmit simultaneously with any other antenna or transmitter, except in accordance with FCC multi-transmitter product procedures.

FCC Caution:

Any changes or modifications to the equipment not expressly approved by the party responsible for compliance could void user’s authority to operate the equipment.

Supplier’s Declaration of Conformity

 47 CFR  §  2.1077 Compliance Information

 Unique Identifier: RD28

 Responsible Party  –  U.S. Contact Information

 Company: Samsung Semiconductor Inc.

Street Address : 3655 N 1st St San Jose, CA

Zip Code : 95134

Contact information : Kevin Lee / email : lee.kevinj@samsung.com

phone : +1-408-544-4000

Expected Service Life time and Warranty

 Expected Service Life Time

–  S-PATCH is guaranteed to last for a minimum of two years.

Product Warranty

The warranty covers a year. However, the conditions excluded by the warranty are as follows.

– Natural aging of the product from daily usage

– Product damage due to improper storage

– Product damage due to improper usage

Company Name and Address 

Company name: Samsung Electronics Co., Ltd.

Address: 1-1, Samsungjeonja-ro, Hwaseong-si, Gyeonggi-do, 18448 Korea

Tel : +(82) 31-8096-7012

e-mail: s.patch@samsung.com

Samsung-Logo

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