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Samsung SDS S-PATCH3-Cardio User Manual

Wearable health monitoring system
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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
[1]

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Summary of Contents for Samsung SDS S-PATCH3-Cardio

  • Page 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...
  • Page 2 Revision History Revision Issue Date Contents of revision Number Rev.0.0 2017.07.12 Established by Manufacturer’s User Manual Policy...

  • Page 3: Table Of Contents

    Conditions for Usage ........................7 2.4.1 Conditions for Storage ........................7 2.4.2 Cleaning Condition ........................... 7 2.4.3 Components and Installation of S-PATCH3-CARDIO ................8 Main Device Components ........................8 Accessory Components ..........................9 How to Install S-PATCH3-CARDIO ....................10 Installing S-PATCH ........................10 3.3.1 Precautions ...............................
  • Page 4 Labels and Packaging ............................ 20 Labels ................................. 20 Label for Packaging ........................20 6.1.1 Label for module ..........................20 6.1.2 Packaging ..............................21 Package List ............................. 21 6.2.1 Package Units ..........................21 6.2.2 6. Information on EMC ............................22 Guidance and Manufacturer’s Declaration – Electromagnetic Emissions ......... 22 Guidance and Manufacturer’s Declaration –...

  • Page 5: Product Introduction

    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.

  • Page 6: Contra-Indication

    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;...

  • Page 7: Usage And Storage Conditions

    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 −25℃- 70℃ (-13°F to 158°F) 1) Temperature: 2) Relative humidity: 10%-95%( non-condensing) 3) Atmospheric pressure: 700hPa-1060hPa 4) Keep the device in the case when it doesn't use.

  • Page 8: Components And Installation Of S-Patch3-Cardio

    3. Components and Installation of S-PATCH3-CARDIO 3.1 Main Device Components S-PATCH3-CARDIO <S-PATCH3-CARDIO> Labe Name Description Main Body1 Coin battery inset module Main Body2 Main PCB module Connect Cable Cable between two main bodies Power Button Power On/Off button LED Lamp to indicate the states...

  • Page 9: Accessory Components

    Label Name Description Multi-purpose monitoring electrodes with sticky gel Electrode feature (high performance adhesive and foam backing) Note: Use the FDA registered Electrode. Power supply for S-PATCH3-CARDIO. DC 3V Coin Battery Battery. The Applied Parts are main device and electrode...

  • Page 10: How To Install S-Patch3-Cardio

    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 [10]...

  • Page 11: 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.

  • Page 12: Using And Operating S-Patch3-Cardio

    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. S-PATCH3-CARDIO 3) Push the power button longer than 3 seconds.
  • Page 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.
  • Page 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”...
  • Page 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. [15]...
  • Page 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”...

  • Page 17: Specifications

    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...

  • Page 18: Error Message

    4.3 Error Message Error Situation Solution Message The server When an error has occurred at server and the Contact service desk and encountered mobile request cannot be executed enquire. an error No data to When no data has been recorded because there send is an error with time of gateway device and the Reinstall App...

  • Page 19: Heart Rate Algorithm

    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”...

  • Page 20: Labels And Packaging

    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 [20]...

  • Page 21: Packaging

    Components Quantity S-PATCH3-CARDIO module Electrodes Main Box Battery Manual 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 [21]...

  • Page 22: Information On Emc

    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...

  • Page 23: Guidance And Manufacturer's Declaration - Electromagnetic Immunity

    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. IEC 60601 Test Compliance Immunity test Electromagnetic environment - Guidance...

  • Page 24: Recommended Separation Distances Between Portable And Mobile Rf Communications Equipment And The Eut

    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. 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.

  • Page 25: Immunity And Compliance Level

    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.

  • Page 26: Guidance And Manufacturer's Declaration - Electromagnetic Immunity

    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. IEC 60601 Compliance Immunity test Electromagnetic environment - Guidance...

  • Page 27: Fcc Compliance Statement

    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.

  • Page 28: Company Introduction

     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.

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