Samsung S-PATCH User guide

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.

Samsung Electronics Co., Ltd.

Document No.: S-UM-01 (Rev. 0.3)

1-1, Samsungjeonja-ro, Hwaseong-si, Gyeonggi-do, South Korea

Samsung Confidential [1]

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

Samsung Confidential [2]

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

<TOP>

①

②

③

⑤

④

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

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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

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

4.1.2. Cradle

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②

;

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

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

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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

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

①

②

③

④

⑤

⑥

4.1.4. Mobile app

[Device connection on] [Device connected]

4.2. Accessory Components

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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

o Windows 10 installed PC

- 200MB free disk space or greater

- Minimum High Speed USB 2.0

o PC software

- Installation file (USB flash drive)

o Sensor device
o Cradle and USB cable

4.3.2. System Initialization

1) PC software installation

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

o Open the sliding door on the bottom of the Sensing module to connect the Cradle

o Attach 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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o User name: Admin
o Password: (Password provided separately in the packing box)
o The 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’

o Enter Serial number printed in Packing box or Sensor device’s bottom side
o Setup the maximum recording time (default time is 72 hours)
o Setup the Start time (default time is set by current time in user PC)
o After 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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Sensing module

Battery module

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.

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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 “Multi­tasking” 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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o ECG Graph Preview

 Navigation Button: Move recorded data along X-axis of time

o 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

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

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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

5.3. Specifications

S-PATCH Specifications

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5.4. Error Message

Figure 1

Figure 2

5.4.1. Device Disconnection

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

5.4.2. 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.

5.4.3. 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.

5.4.4. 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.

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Figure 3

Figure 4

Figure 5

5.5. 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.

5.6. 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.

A. The required specification of the interface and IT -Network that combines PEMS

1) 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)

B. Technical specification about network connection of PEMS including security

features.

1) 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.

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2) Specification of Network connection

601

avg

RRI

HR

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.

C. 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.

5.7. 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.

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.

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6. Labels and Packaging

PRODUCT NAME

MODEL NAME

RATED VOLTAGE 3.0 V d.c. (Lithium coin battery) FCC ID A3LSPATCH

Dimension (Sensing module) 29 x 5.25 mm [Diameter x Height] IP Grade IP22

Dimension (Battery module) 29 x 5.8 mm [Diameter x Height] Serial Number (Sensor device)

Dimension (Connect cable)

110 ± 10 mm Serial Number (Cradle)

Dimension (Cradle) 44.5 x 19.4 mm [Diameter x Height] Date of manufacture

CAUTION - Electric shock
" To avoid electrical shock, do no disassemble the device "

Please read the user's manual carefully before use CF Type Prescription only Keep Dry

Manufacturer : Samsung Electronics Co., Ltd.
1-1, Samsungj eonja-ro, Hwaseong-si,
Gye onggi-do, 18448 Korea
Tel) [phone]
E-mai l) [e-mail]

WEEE
MADE IN KOREA

Wearable Health Recording System

S-PATCH

6.1. Labels

6.1.1. Label for Packaging

6.1.2. Label for the Sensor device

6.1.3. Label for the Cradle

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6.1.4. Descriptions of the visual symbols of the label

No.

Symbol

Description

1

The serial number that identifies the object.

2

Date of manufacture

3

Manufacturer

4

Caution / Warning

5

Instruction for User Manual

6

Type CF applied part

7

Prescription only

8

WEEE Mark

9

Keep Dry

10

Non-ionizing radiation

11

MR unsafe

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

6.2. Packaging

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7. Electromagnetic 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

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%.

7.1. 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.

7.2. 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.

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7.3. Guidance and Manufacturer’s Declaration – Electromagnetic Immunity

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 :

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.

- 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.

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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.

7.4. Recommended separation distances between portable and mobile RF

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.

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.

7.5. Immunity and Compliance Level

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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

8. FCC Compliance Statement

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

(1) This device may not cause harmful interference, and

(2) 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.

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Supplier's Declaration of Conformity

47 CFR § 2.1077 Compliance Information

Unique Identifier: RD28

–

Responsible Party

Company: Samsung Semiconductor Inc.

Street Address : 3655 N 1st St

City, State : San Jose, CA

Zip Code : 95134

U.S. Contact Information

Contact information : Kevin Lee / email :

[e-mail] / phone : [phone]

9. Expected Service Life time and Warranty

9.1. Expected Service Life Time

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

9.2. 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

10. 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: [e-mail]

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