FCC ID: A3LSPATCH Wearable health recording system

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 Samsung Confidential

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Revision History Revision Number Rev.0.0 Issue Date 2020.01.20 Rev.0.1 2020.01.28 Rev.0.2 Rev.0.3 2020.02.07 2020.02.14 Contents of Revision Established by Manufacturers User Manual Policy Section 5.6, Updated specification of external device connection Section 4.2, Deleted applied part description Section 5.3, Updated BLE specification Section 8, Added FCC SDoC information Samsung Confidential

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Table of Contents 1. Product Introduction ..................................................................................................................................................... 5 Introduction........................................................................................................................................................... 5 1.1. 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 Manufacturers Declaration Electromagnetic Emissions .......................... 27 Samsung Confidential

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7.2. Guidance and Manufacturers Declaration Electromagnetic Immunity .......................... 27 7.3. Guidance and Manufacturers Declaration Electromagnetic Immunity .......................... 28 7.4. Recommended separation distances between portable and mobile RF communications equipment and the S-PATCH .............................................................................................. 29 Immunity and Compliance Level ............................................................................................................. 29 7.5. 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 Samsung Confidential

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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 patients 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 physicians 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. Samsung Confidential

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2. Cautions 2.1. General action. 2.2. Safety 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 manufacturers 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 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. 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 doctors 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 patients skin to react with irritation or reddening. Samsung Confidential

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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 (-13F to 158F) 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 equipment 3. Warning 1) Clean the device with soft, dry cloth 2) Equipment failure may occur due to dust and debris during long-term use of the 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>

Samsung Confidential

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4.1.2. Cradle

<BOTTOM>

Label Name Description Battery module Sensing module Connect Cable Power Button LED Coin battery inset module ECG Sensing module Connection between Battery module and Body2 Power On/Off button 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 Label Name Description Module connection pins 10 pogo pins for connecting to S-Patch module Push button Locking door USB cable LED Ferrite core Locking door open button Locking door to fasten S-Patch module to the Cradle Micro type B USB Cable LED Lamp to indicate the cradle state Electromagnetic Interference blocking material Samsung Confidential

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Do not remove Ferrite 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 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 Samsung Confidential

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ECG signal Graph Patient ECG signal graph chart display

- Zoom In/Out, Cursor, Marker Analysis Heart Rate Table Heart Rate Graph Heart rate graph chart display 4.1.4. Mobile app

[Device connection on]

[Device connected]

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 4.2. Accessory Components Samsung Confidential

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<Electrode>

<Battery>

Label Name Description Electrode Battery Multi-purpose recording electrodes with sticky gel feature

(high performance adhesive and foam backing) Note: Use the FDA registered Electrode. 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 Install setup file (S-Patch PC software setup.exe) on the USB flash drive o o Open the Spatch Management.exe Samsung Confidential

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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 Samsung Confidential

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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 devices 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 Samsung Confidential

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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 Samsung Confidential

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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 users 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. Samsung Confidential

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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 patients smart phone. 2) Install the Mobile app (S-PATCH mobile app.apk) on the smart phone. Samsung Confidential

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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 Samsung Confidential

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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 Samsung Confidential

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Permission, so, BLE, Location and Storage permissions are requested. If its 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 patients 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:

- Traveling on aircraft

- Undergoing an MRI Showering, bathing, or swimming 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 Samsung Confidential

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o ECG Graph Preview Navigation Button: Move recorded data along X-axis of time o ECG Graph Zoom Cursor Marker Add

- 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

- Zoom in limit area: X axis 1sec / Y axis 2mV

- Zoom out limit area: X axis Full recorded time / Y axis 100mV Shift + mouse left click area selection: selected area zoom in/out

- Create Cursor: Menu-View-Cursor

- Cursor1, 2 and difference will be displayed

- Place the mouse pointer over the graph and right click Symptom Marking

- 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 Samsung Confidential

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5.3. Specifications S-PATCH Specifications Classification Performance Name Description CF-Type Single channel Type Channel Communication with mobile device Bluetooth

+/- 300mV DC Offset Tolerance 12 bits ADC Resolution ADC Sampling Rate 256 Samples/Second

>100 M Input Impedance 3Vd.c. (Lithium coin battery) Power Supply Up to 72 Hr. Battery Life F/W version V1.00 S1SBP6A (Cortex-M4F microprocessor) CPU Dialog DA14583 (ARM Cortex-M0) BLE App(Android) Android version 9 or later 8g Weight (Exc. Battery) 29*5.5 (mm), 29*4.4 (mm) [D*H]

Dimension (Battery module,2) Dimension (Connect Cable) 110 10 (mm) Max. 10 Meters Bluetooth GFSK Radio Modulation Radio Frequency 2,402 MHz ~ 2,480 MHz 0 dBm Max. RF Output Power Circuitry Power Requirements Software Physical Characteristics Communication Samsung Confidential

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5.4. Error Message 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, its changed to LEAD ON state. Figure 1 Figure 2 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. Samsung Confidential

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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. Samsung Confidential

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2) 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. 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. Samsung Confidential

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HR 60 1 RRI avg 6. Labels and Packaging 6.1. Labels 6.1.1. Label for Packaging 6.1.2. Label for the Sensor device 6.1.3. Label for the Cradle Samsung Confidential

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PRODUCT NAME Wearable Health Recording System MODEL NAME S-PATCH RATED VOLTAGE 3.0 V d.c. (Lithium coin battery) FCC ID Dimension (Sensing module) 29 x 5.25 mm [Diameter x Height]

IP Grade A3LSPATCH 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 Please read the user's manual carefully before use CF Type Prescription only Keep Dry CAUTION - Electric shock

" To avoid electrical shock, do no disassemble the device "

Manufacturer : Samsung Electronics Co., Ltd. 1-1, Samsungjeonja-ro, Hwaseong-si, Gyeonggi-do, 18448 Korea Tel) +82-31-8096-7012 E-mail) s.patch@samsung.com WEEE MADE IN KOREA 6.1.4. Descriptions of the visual symbols of the label No. Symbol Description The serial number that identifies the object. 1 2 3 4 5 6 7 8 9 10 11 Date of manufacture Manufacturer Caution / Warning Instruction for User Manual Type CF applied part Prescription only WEEE Mark Keep Dry Non-ionizing radiation MR unsafe 6.2. Packaging Identification Main Box Sub Box Components Sensor device Electrodes Battery Quick guide Cradle USB cable USB flash drive Quantity 1 4 1 1 1 1 1 Samsung Confidential

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7. Electromagnetic Environment 7.1. Guidance and Manufacturers 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 RF Emissions CISPR 11 Class B 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 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 7.2. Guidance and Manufacturers 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 Compliance level IEC 60601 Test 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%. Samsung Confidential

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7.3. Guidance and Manufacturers 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 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 Electromagnetic environment - Guidance 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 150kHz to 80MHz d = 1.166 80MHz to 800MHz d = 2.333 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. Samsung Confidential

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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 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]

0.01 0.1 1 10 100 Separation distance according to frequency of transmitter [m]

150kHz to 80MHz 80MHz to 800MHz 800MHz to 2.5GHz V1=3Vrms 0.116 0.368 1.166 3.687 11.660 E1=3V/m 0.1166 0.3687 1.1660 3.6872 11.6600 E1=3V/m 0.2333 0.7378 2.3333 7.3785 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. 7.5. Immunity and Compliance Level Samsung Confidential

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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 users authority to operate the equipment. Samsung Confidential

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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 City, State : San Jose, CA Zip Code : 95134 Contact information : Kevin Lee / email : lee.kevinj@samsung.com / phone : +1-408-544-4000 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: s.patch@samsung.com Samsung Confidential

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FCC ID : A3LSPATCH Certification LABEL location The Label shown shall be permanently affixed at a conspicuous location on the device and be readily visible to the user at the time of purchase 1. Sensor device 2. Cradle

- The device is small that it is not practicable to place the statement specified under 15.19 statement request, the information required by this paragraph shall be placed in a prominent location in the user's manual.

SAMSUNG Electronics CO., Ltd.

(Maetan-dong) 129, Samsung-ro, Yeongtong-gu, Suwon-si, Gyeonggi-do, Republic of Korea Model Number : S-PATCH FCC ID: A3LSPATCH To whom it may it concern:

I hereby appoint JONG-BIN KIM to sign letters and applications for any filings with regulatory agencies on our behalf, and to receive and exchange data between our company, the agents company and the agency in connection with certification for any products that our company owns or manufactures. Sincerely,

Jenni, Chun / General Manager Samsung Electronics America, Inc. Address: 19 Chapin Rd., Building D Pine Brook, NJ 07058 Tel: 1-973-808-6375 Date: Feb, 13, 2020

SAMSUNG ELECTRONICS 1-1, Samsungjeonja-ro, Hwaseong-si, Gyeonggi-do 18448 Korea Date: DEC 30, 2019 UL Verification Services Inc. 47173 Benicia Street Fremont, CA 94538, USA To whom it may concern:

I, the undersigned, hereby authorize UL Verification Services Inc. to act on our behalf in all manners relating to application for equipment authorization, including signing of all documents relating to these matters. Any and all acts carried out by UL Verification Services Inc. on our behalf shall have the same effect as acts of our own. I, the undersigned, hereby certify that we are not subject to a denial of federal benefits, that includes FCC benefits, pursuant to Section 5301 of the Anti-Drug Abuse Act of 1988, 21 U.S.C. 853(a). In authorizing UL Verification Services Inc. as our representative, we still recognize that we are responsible to:

a) b) c) d) e) f) comply with the relevant provisions of the certification program;

make all necessary arrangements for the conduct of the evaluation, including provision for examining documentation and access to all areas, records (including internal audit reports) and personnel for the purposes of evaluation (e.g. testing, inspection, assessment, surveillance, reassessment) and resolution of complaints;

make claims regarding certification only in respect of the scope for which certification has been granted;

do not use our product certification in such a manner as to bring the Certification Division into disrepute and not make any statement regarding our product certification which the Certification Division may consider misleading or unauthorized;

upon suspension or cancellation of certification, discontinue use of all advertising matter that contains any reference thereto and return any certification documents as required by the Certification Division;

use certification only to indicate the products are certified as being in conformity with specified standards;

g) h) i) j) endeavor to ensure that no certificate or report nor any part thereof is used in a misleading manner;

ensure that any reference to our product certification in communication media such as documents, brochures or advertising, complies with the requirements of the Certification Division;

keep a record of all complaints made known to the us relating to the products compliance with requirements of the relevant standard and to make these records available to the when requested;

take appropriate action with respect to such complaints and any deficiencies found in products or services that affect compliance with the requirements for certification;

k) document the actions taken. This authorization is valid until further written notice from the applicant. Sincerely Yours, Jongbin Kim / Staff engineer Samsung Electronics Co., Ltd. REMARK:

1. This authorization letter will be sent along with your application when filing with UL Verification Services Inc. Please follow the format and type it on company letterhead and send original to us. Authorized signature must be in agreement with grantee code contact in FCC database and Industry Canada contact information. 2. 3.

SAMSUNG ELECTRONICS 1-1, Samsungjeonja-ro, Hwaseong-si, Gyeonggi-do 18448 Korea Federal Communications Commission 7435 Oakland Mills Road Columbia MD 21046 Subject:

Request for Confidentiality FCC ID:

A3LSPATCH To Whom It May Concern:

Pursuant to the provisions of Sections 0.457 and 0.459 of the Commissions rules (47 CFR 0.457, 0.459), we are requesting the Commission to withhold the following attachments as confidential document from public disclosure indefinitely. Schematic Diagram Block Diagram Operation description Antenna Specification Part Location External Photos Internal Photos Test Setup Photos User Manual Above mentioned document contains detailed system and equipment description are considered as proprietary information in operation of the equipment. The public disclosure of above documents might be harmful to our company and would give competitor an unfair advantage in the market. In additional to above mentioned documents, pursuant to Public Notice DA 04-1705 of the Commissions policy, in order to comply with the marketing regulations in 47 CFR 2.803 and the importation rules in 47 CFR 2.1204, while ensuring that business sensitive information remains confidential until the actual marketing of newly authorized devices. We are requesting the commission to grant short-term confidentiality request on the following attachments until It is our understanding that all measurement test reports, FCC ID label format and correspondent during certification review process cannot be granted as confidential documents and those information will be available for public review once the grant of equipment authorization is issued. Best Regards Jongbin Kim / Staff engineer Samsung Electronics Co., Ltd. Dec 30, 2019