Samsung SDS SPATCH3 Wearable Health Monitoring System User Manual

Samsung SDS Co., Ltd. Wearable Health Monitoring System

User Manual

     [1]       USER MANUAL  Wearable Health Monitoring System    (MODEL: S-PATCH3-Cardio)          Caution: Federal law restricts this device to sale by or on the order of a physician.   Document No: SDS-UM-01 (Rev. 0)   Samsung SDS Co., Ltd.  125, Olympic-ro 35-gil, Songpa-gu, Seoul, Republic of Korea
     [2] Revision History  Revision Number Issue Date Contents of revision Rev.0.0 2017.07.12 Established by Manufacturer’s User Manual Policy
     [3] Contents  1. Product Introduction .................................................................................................................................... 5 1.1 Introducing S-PATCH3-CARDIO ......................................................................................................... 5 1.2 Indication for Use ...................................................................................................................................... 5 2. Cautions ............................................................................................................................................................. 5 2.1 General ......................................................................................................................................................... 5 2.2 Safety ............................................................................................................................................................ 5 2.3 Contra-Indication ....................................................................................................................................... 6 2.4 Usage and Storage Conditions ................................................................................................................ 7 2.4.1 Conditions for Usage ........................................................................................................................ 7 2.4.2 Conditions for Storage ...................................................................................................................... 7 2.4.3 Cleaning Condition ........................................................................................................................... 7 3. Components and Installation of S-PATCH3-CARDIO ............................................................................ 8 3.1 Main Device Components ........................................................................................................................ 8 3.2 Accessory Components ............................................................................................................................ 9 3.3 How to Install S-PATCH3-CARDIO ................................................................................................. 10 3.3.1 Installing S-PATCH ....................................................................................................................... 10 3.4 Precautions ............................................................................................................................................... 11 4. Using and Operating S-PATCH3-CARDIO ............................................................................................. 12 4.1 How to Use S-PATCH3-CARDIO ..................................................................................................... 12 4.2 Specifications ........................................................................................................................................... 17 4.2.1 S-PATCH3-CARDIO Specifications ......................................................................................... 17 4.3 Error Message .......................................................................................................................................... 18 4.4 Maintenance ............................................................................................................................................. 18 4.5 Specification of External Device connection .................................................................................... 18 5. Heart Rate Algorithm .................................................................................................................................... 19 5.1 HR calculation per beat .................................................................................................................... 19 5.2 Average HR calculation of a section .......................................................................................... 19
     [4] 6. Labels and Packaging .................................................................................................................................... 20 6.1 Labels ......................................................................................................................................................... 20 6.1.1 Label for Packaging ....................................................................................................................... 20 6.1.2 Label for module ............................................................................................................................. 20 6.2 Packaging .................................................................................................................................................. 21 6.2.1 Package List ..................................................................................................................................... 21 6.2.2 Package Units .................................................................................................................................. 21 6.    Information on EMC ....................................................................................................................................... 22 6.1 Guidance and Manufacturer’s Declaration – Electromagnetic Emissions ................................. 22 6.2 Guidance and Manufacturer’s Declaration – Electromagnetic Immunity .................................. 22 6.3 Guidance and Manufacturer’s Declaration – Electromagnetic Immunity .................................. 23 6.4 Recommended separation distances between portable and mobile RF communications equipment and the EUT ..................................................................................................................................... 24 6.5 Immunity and Compliance Level ........................................................................................................ 25 6.6 Guidance and Manufacturer’s Declaration – Electromagnetic Immunity .................................. 26 7. FCC Compliance Statement ......................................................................................................................... 27 8. Expected Service Life time and Warranty ................................................................................................ 27 8.1 Expected Service Life Time ................................................................................................................. 27 8.2 Product Warranty .................................................................................................................................... 27 9. Company Introduction ................................................................................................................................... 28 9.1 Company Name and Address ............................................................................................................... 28
     [5] 1. Product Introduction 1.1 Introducing S-PATCH3-CARDIO This product is intended to measure, transfer and record electrocardiogram signal.  The viewer on mobile device may display ECG wave form, Heart Rate, Respiration Rate, Heart Rate Variability and other information.    The product consists of S-PATCH3-CARDIO body signal sensing module, ECG electrodes and mobile app viewer to monitor the signals. • Product Name– Wearable health Monitoring System • Model Name– S-PATCH3-CARDIO   • Manufacturer–SAMSUNG SDS Co., Ltd.  1.2 Indication for Use This product is intended to measure, transfer and record electrocardiogram signal. The viewer on mobile device may display ECG wave form, Heart Rate and other information. The product consists of  S-PATCH3-CARDIO  body  signal  sensing  module,  mobile  application  and  web  portal  of electrocardiogram analysis for physician. The S-PATCH3-CARDIO signal sensing module transmits data through wireless communication to mobile device. The S-PATCH3-CARDIO wearable health monitoring system monitors and displays: - Heart Rate - ECG signal - The  connection  between  S-PATCH3-CARDIO  and  mobile  device  is  using  Bluetooth communication.    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.  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.
     [6] 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) Conductive parts of electrodes and associated connectors for type CF applied parts, should not contact other conductive parts including earth;  2.3 Contra-Indication 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.
     [7] 2.4 Usage and Storage Conditions  2.4.1 Conditions for Usage 1) Temperature: 5℃- 40℃(41℉ to 104℉) 2) Relative humidity: 10%-95%(non-condensing) 3) Atmospheric pressure: 700hPa-1060hPa  2.4.2 Conditions for Storage 1) Temperature: −25℃- 70℃ (-13°F to 158°F) 2) Relative humidity: 10%-95%( non-condensing) 3) Atmospheric pressure: 700hPa-1060hPa 4) Keep the device in the case when it doesn't use.  2.4.3 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.
     [8] 3. Components and Installation of S-PATCH3-CARDIO  3.1 Main Device Components   <S-PATCH3-CARDIO> Label Name Description 1 Main Body1 Coin battery inset module 2 Main Body2 Main PCB module 3 Connect Cable Cable between two main bodies 4 Power Button Power On/Off button 5 LED LED Lamp to indicate the states 6 Electrode  connect hole Holes for ECG electrodes connecting      S-PATCH3-CARDIO 6 6 5 4 2 1 3 S-PATCH3-CARDIO
     [9] 3.2 Accessory Components   <Electrode>  <Battery>                Label Name Description 1 Electrode Multi-purpose  monitoring  electrodes  with  sticky  gel feature (high performance adhesive and foam backing) Note: Use the FDA registered Electrode. 2 Battery Power  supply  for  S-PATCH3-CARDIO.  DC  3V  Coin Battery.  The Applied Parts are main device and electrode
     [10]    3.3 How to Install S-PATCH3-CARDIO  3.3.1 Installing S-PATCH 1) Download  the  S-PATCH  App  from  Google  Play  Store (Android  KitKat  or  later).  The device must support Bluetooth Low Energy.  2) Install the downloaded file on user’s mobile device.  3) Insert battery to main body 1 of S-PATCH3-CARDIO.   First, release the screw on main body1 using screw driver. Second, open the upper case of main body1 and insert the battery.   Lastly, close the case and lock the screw.   Caution ;       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.  4) Connect Electrodes to electrode connect hole in each side of S-PATCH3-CARDIO.         S-PATCH3-CARDIO
     [11] 3.4 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 S-PATCH3-CARDIO is not likely to be used for some time. 3) Please ensure user’s hands are clean and dry when handle the S-PATCH3-CARDIO 4) The  body  hair  possibly  causes  contact  problem  which  results  a  fault  detection  of physiological data. 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 the shop where you purchased the product.
     [12] 4. Using and Operating S-PATCH3-CARDIO  4.1 How to Use S-PATCH3-CARDIO 1) After connect the electrodes with S-PATCH3-CARDIO, peel the plastic on the backside of the electrodes. 2) Attach the S-PATCH3-CARDIO on recommended position as drawn.             3) Push the power button longer than 3 seconds.  4) Confirm that the LED is ON and OFF 3 times. S-PATCH3-CARDIO
     [13]   < ON >        < OFF >   5) Put the Bluetooth mode to “ON” mode of user’s mobile device.  6) Please execute S-PATCH App  6-1) Open the App to see following sequence of screens:    6-2) Press “Connect S-Patch” button on lower center of screen.  6-3) Wait while the app searches for device.  6-4) Select device to connect.  6-5)  Press “Connect”  after  confirming  test  sequence(test ID)  and  patient name  (patient ID).
     [14] 6-6) User’s ECG graph can be viewed from screen.   Clicking on the live ECG graph will pull up vertical screen for full screen view of ECG.  6-7)  Press  “Add  Symptom”  button  to  record  any  symptoms  instantly.  This  button  will save a “not specified” symptom on diary tab to which user can add details at a later time.    After  button  is  pressed  “Symptom  has  been  saved”  message  appears  momentarily  at bottom of screen.
     [15]   6-8) Press “+ New Diary” to create a new diary entry.  6-9) Enter start date and time of symptom.  6-10) Enter end date and time of symptom.    6-11) Press “Select Symptom” and select a symptom from list.
     [16]  6-12) Press “Select Activity” and select an activity from list.  6-13) Press “Confirm” to save the new diary entry.  6-14) When the duration of test is over, test will automatically upload  to cloud, but in case user desires to end the test early press the menu button on upper left of screen.    6-15) Press “End Test” on the bottom of menu options.  6-16) An “End test” message will appear and user can press “End” to end the test.  6-17) When manually ending the test, the test data also requires manual sending. After the test is ended, screen will change to send data screen.
     [17]   6-18) Press “Send Data” button on lower center of screen (requires internet connection).  6-19) Wait for app to finish transmitting data.  6-20) Click “Reset Application” to prepare the app for next S-Patch test.   4.2 Specifications  4.2.1 S-PATCH3-CARDIO 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 1000 Samples/Second Input Impedance >100 MΩ Power Requirements Power Supply 3 Vd.c. (Lithium coin battery) Battery Life 120 Hr. Software F/W version V1.00 CPU S1SBP6A (Cortex-M4F microprocessor) BLE Dialog DA14583(ARM Cortex-M0) App(Android) Kitkat(API19) or later Physical Characteristics Weight (Exc. Battery) 8g Dimension(Main Body1,2) 29*5.5(mm),  29*4.4(mm)  [Diameter* Height] Dimension(Connect Cable) 110  ± 10 (mm)
     [18] 4.3 Error Message Error Message Situation Solution The server encountered an error When an error has occurred at server and the mobile request cannot be executed Contact service desk and enquire. No data to send When no data has been recorded because there is an error with time of gateway device and the test ends as soon as it has been started Reinstall App Failed to connect to service When mobile device cannot access server due to network error Re-try  after  moving  to area  with  LTE  or  Wifi connection 4.4 Maintenance  For cleaning, gently wipe with a soft dry cloth after using the S-PATCH 3. Please attempt to keep S-PATCH3-CARDIO dust free. S-PATCH is waterproof. 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.  4.5   Specification of External Device connection The  S-Patch3  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) Main 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)                     Data to Device – Data Channel                         Transmits the data to the device  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. 2) Specification of Network connection Communication  protocol:  the  protocol  between  the  main  unit  and  the  mobile  app  is  a  BLE central (Mobile) – peripheral (main unit) 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.
     [19] 5. Heart Rate Algorithm   5.1 HR calculation per beat When  calculating  HR  of  each beat,  9  beats  including  previous 4  beats and  following 4  beats are required.  Number of effective sections / (( time of B9 – time of B1 ) / 60 )  Definition of “section” is the interval between consecutive beats such as B1 and B2, and in case 1 of the 2 beats is A ( Artifact ) , exclude it from effective section. If there are less than 5 effective sections, no calculation.  As the above picture, if beats S A N N V N N N N are within a section of 5 seconds and the excluded section is 1 second, the V beat in the center will have HR value of 6 / ((5-1) / 60) = 91 bpm.  5.2 Average HR calculation of a section Average HR of a section is calculated with the beats included in the section.   If the above data is within a 20 second frame, the average HR is calculated as follows:   Number of effective sections / (( Total length of effective sections ) / 60 )  At this time, “section” refers to the interval between consecutive beats such as B1 and B2, and in case 1 of the 2 consecutive beats is A ( Artifact ) , exclude it from effective section before calculation. Therefore, there are 12 effective sections, and if the total length of invalid sections is 2 seconds , the average is calculated as follows:  12 / ((20-2) / 60) = 40 bpm
     [20] 6. Labels and Packaging 6.1 Labels 6.1.1 Label for Packaging  6.1.2 Label for module          Front- side 2 Labels                   Rear-side 2 Labels
     [21] - Descriptions on the visual symbols of the label Label 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 of applied part 7  Prescription only 8  WEEE Mark 9  Keep Dry   6.2 Packaging  6.2.1 Package List Classifications Components Quantity Main Box S-PATCH3-CARDIO module 1 Electrodes 4 Battery 1 Manual 1  6.2.2 Package Units 1) S-PATCH3-CARDIO module Main module. 2) Electrodes 4 Electrodes are in the 1 plastic bag. 3) Battery 1 Coin Cell battery is shipped at package. 4) Manual
     [22]  7.    Information on EMC  7.1 Guidance and Manufacturer’s Declaration – Electromagnetic Emissions - The EUT is intended for use in the electromagnetic environment specified below. The customer or the user of the EUT should assure that it is used in such an environment. Immunity test Compliance Electromagnetic environment - Guidance RF Emissions CISPR 11 Group 1 The S-PATCH3 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-PATCH3 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 Manufacturer’s Declaration – Electromagnetic Immunity - The EUT is intended for use in the electromagnetic environment specified below. The customer or the user of the EUT 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%.
     [23]  7.3 Guidance and Manufacturer’s Declaration – Electromagnetic Immunity - The EUT is intended for use in the electromagnetic environment specified below. The customer or the user of the EUT should assure that it is used in such an environment. Immunity test   IEC 60601 Test level   Compliance   level   Electromagnetic environment - Guidance Conducted RF   IEC 61000-4-6               Radiated RF   IEC 61000-4-3   3 V   0,15 MHz – 80 MHz 6 V in ISM and amateur radio bands between 0,15 MHz and 80 MHz 80 % AM at 1 kHz    10 V/m   80 MHz – 2,7 GHz   80 % AM at 1 kHz   3 V   0,15 MHz – 80 MHz 6 V in ISM and amateur radio bands between 0,15 MHz and 80 MHz 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-PATCH3, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.     Recommended separation distance        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 :
     [24] 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 EUT is used exceeds the applicable RF compliance level above, the EUT should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the EUT. 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 EUT   - There is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the EUT can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the EUT 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
     [25] 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 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
     [26] 7.6 Guidance and Manufacturer’s Declaration – Electromagnetic Immunity - The EUT is intended for use in the electromagnetic environment specified below. The customer or the user of the EUT should assure that it is used in such an environment. Immunity test IEC 60601 test level Compliance level Electromagnetic environment - Guidance Conducted RF   IEC 61000-4-6        Radiated RF   IEC 61000-4-3   3 V   0,15 MHz – 80 MHz 6 V in ISM and amateur radio bands between 0,15 MHz and 80 MHz 80 % AM at 1 kHz    10 V/m   80 MHz – 2,7 GHz   80 % AM at 1 kHz   3 V   0,15 MHz – 80 MHz 6 V in ISM and amateur radio bands between 0,15 MHz and 80 MHz 80 % AM at 1 kHz    10 V/m   80 MHz – 2,7 GHz   80 % AM at 1 kHz   The EUT must be used only in a shielded location with a minimum RF shielding effectiveness and, for each cable that enters the shielded location with a minimum RF shielding effectiveness and, for each cable that enters the shielded location     Field strengths outside the shielded location from fixed RF transmitters, as determined by an   electromagnetic site survey, should be less than 3V/m.a     Interference may occur in the vicinity of equipment marked with the following symbol:    NOTE 1) These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.  NOTE 2) It is essential that the actual shielding effectiveness and filter attenuation of the shielded location be verified to assure that they meet the minimum specification.   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 outside the shielded location in which the EUT is used exceeds 3V/m, the EUT should be observed to verify normal operation.   If abnormal performance is observed, additional measures may be necessary, such as relocating the EUT or using a shielded location with a higher RF shielding effectiveness and filter attenuation.
     [27]  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.    9 Expected Service Life time and Warranty  9.1 Expected Service Life Time - S-PATCH3-CARDIO 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
     [28]  Product damage due to improper storage  Product damage due to improper usage  10 Company Introduction  10.1 Company Name and Address Company name:    Samsung SDS Co., Ltd. Address: 125, Olympic-ro 35-gil, Songpa-gu, Seoul, Republic of Korea Tel: +82-2-6155-3114  10.2 EC Representative   Name: Samsung SDS Europe Address: KT13 0NY, 1st Fl. No. 5, The Heights, Brooklands Weybridge                   Surrey, United Kingdom Contacts:  Phone: +44-7825-035-687  Fax: N/A

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