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Samsung S-PATCH User Manual

Wearable health recording system
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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
[1]

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Summary of Contents for Samsung S-PATCH

  • Page 1 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...
  • Page 2 2020.01.20 Established by Manufacturer’s User Manual Policy Section 5.6, Updated specification of external device Rev.0.1 2020.01.28 connection Section 4.2, Deleted applied part description Rev.0.2 2020.02.07 Section 5.3, Updated BLE specification Rev.0.3 2020.02.14 Section 8, Added FCC SDoC information Samsung Confidential...

  • Page 3: Table Of Contents

    2.3.1. Conditions for Usage ........................... 7 2.3.2. Conditions for Storage ........................7 2.3.3. Cleaning Condition ..........................7 Warning ....................................7 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.
  • Page 4 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 FCC Compliance Statement ............................30 Expected Service Life time and Warranty ......................

  • Page 5: Product Introduction

    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.

  • Page 6: Cautions

    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.

  • Page 7: Usage And Storage Conditions

    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.

  • Page 8: Cradle

    10 pogo pins for connecting to S-Patch module ① Push button Locking door open button ② Locking door Locking door to fasten S-Patch module to the Cradle ③ USB cable Micro type B USB Cable ④ LED Lamp to indicate the cradle state ⑤...

  • Page 9: Pc Software

    File / Device / View / About ① Recording Start Time : DD MM YYYY hh:mm Duration : hh:mm:ss File Information ② Serial number : 8byte Sampling Frequency : 256Hz Symptom Marking Input abnormal symptom time recorded by the ③ Samsung Confidential...

  • Page 10: Mobile App

    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 4.2. Accessory Components Samsung Confidential [10]...

  • Page 11: How To Start S-Patch

    Minimum High Speed USB 2.0 PC software Installation file (USB flash drive) Sensor device 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 Open the Spatch Management.exe Samsung Confidential [11]...
  • Page 12 Open the sliding door on the bottom of the Sensing module to connect the Cradle 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...
  • Page 13 Enter Serial number printed in Packing box or Sensor device’s bottom side Setup the maximum recording time (default time is 72 hours) Setup the Start time (default time is set by current time in user PC) After completing initial setting, click ‘Save” 9) Click ‘Device-Disconnect’ in the Menu Samsung Confidential [13]...

  • Page 14: Sensor Device Setup

    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 [14]...

  • Page 15: Precautions

    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.

  • Page 16: Connection To The Mobile App

    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.
  • Page 17 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 [17]...
  • Page 18 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”...

  • Page 19: 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...

  • Page 20: Ecg Data Import And Export

    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 [20]...

  • Page 21: Specifications

    5.3. Specifications S-PATCH Specifications Classification Name Description Type CF-Type Performance Channel Single channel Communication with mobile device Bluetooth DC Offset Tolerance +/- 300mV Circuitry ADC Resolution 12 bits ADC Sampling Rate 256 Samples/Second Input Impedance >100 MΩ Power Power Supply 3Vd.c.

  • Page 22: Error Message

    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.

  • Page 23: Maintenance

    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 [23]...

  • Page 24: Heart Rate Algorithm

    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 [24]...

  • Page 25: Labels And Packaging

    " 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, Samsungjeonja-ro, Hwaseong-si, Gyeonggi-do, 18448 Korea WEEE Tel) +82-31-8096-7012 MADE IN KOREA E-mail) s.patch@samsung.com...

  • Page 26: Descriptions Of The Visual Symbols Of The Label

    Instruction for User Manual Type CF applied part Prescription only WEEE Mark Keep Dry Non-ionizing radiation MR unsafe 6.2. Packaging Identification Components Quantity Main Box Sensor device Electrodes Battery Quick guide Sub Box Cradle USB cable USB flash drive Samsung Confidential [26]...

  • Page 27: Electromagnetic Environment

    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. Immunity test...

  • Page 28: Guidance And Manufacturer's Declaration - Electromagnetic Immunity

    7.3. 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. IEC 60601 Test...

  • Page 29: Recommended Separation Distances Between Portable And Mobile Rf Communications Equipment And The S-Patch

    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.

  • Page 30: Fcc Compliance Statement

    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. Samsung Confidential [30]...

  • Page 31: Expected Service Life Time And Warranty

    / 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.

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