Summary of Contents for Samsung S-Patch3
- Page 1 USER MANUAL Wearable Health Monitoring System (MODEL : S-PATCH3) Document No. : S-UM-01 (Rev. 0.2) Samsung Electronics Co., Ltd. 1-1, Samsungjeonja-ro, Hwaseong-si, Gyeonggi-do, South Korea Samsung Confidential...
- Page 2 Revision History Revision Issue Date Contents of revision Number Rev.0.0 2016.12.28 Established by Manufacturer’s User Manual Policy Rev.0.1 2017.1.5 5.1 Label Update Rev.0.2 2017.2.9 5.1 Label Update 서식 있음: 양쪽 Rev.0.2 2017.2.9 4.2.1 Spec Update Samsung Confidential...
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Page 3: Table Of Contents
2.4.1 Conditions for Storage ........................7 2.4.2 Cleaning Condition ........................... 7 2.4.3 Components and Installation of S-PATCH3 ..................8 Main Device Components ........................8 Accessory Components .......................... 9 Display viewer ............................10 How to Install S-PATCH3 ........................18 Installing S-PATCH ........................18 3.4.1... - Page 4 Guidance and Manufacturer’s Declaration – Electromagnetic Immunity ......37 FCC Compliance Statement ........................38 Product Life time and Warranty ......................38 Product Life time ..........................38 Product Warranty ..........................38 Company Introduction ..........................39 Company Name and Address ......................39 Samsung Confidential...
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Page 5: Product Introduction
1-1, Samsungjeonja-ro, Hwaseong-si, Gyeonggi-do, 18448 Korea 1.2 Indication for Use The S-PATCH3 Wearable Health Monitoring System is intended to record, transfer and store single channel electrocardiogram signals. The S-PATCH3 signal sensing module transmits data through wireless communication to mobile device. The product is not intended for pediatric use. -
Page 6: Contra-Indication
8) DO NOT swallow the device or wind the cable around the neck. 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. Samsung Confidential... -
Page 7: Usage And Storage Conditions
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. Samsung Confidential... -
Page 8: Components And Installation Of S-Patch3
3. Components and Installation of S-PATCH3 3.1 Main Device Components <S-PATCH3> Label 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
Description Multi-purpose monitoring electrodes with sticky gel Electrode feature (high performance adhesive and foam backing) Note: Use the FDA registered Electrode. Battery Power supply for S-PATCH3. DC 3V Coin Battery. The Applied Parts are main device and electrode Samsung Confidential... -
Page 10: Display Viewer
3.3 Display viewer 1) Main Display of S-PATCH3 App 서식 있음: 글꼴: (영어) 바탕, (한글) 바탕, 11 pt Samsung Confidential [10]... - Page 11 A.3. BLE Connection Indicator: Bluetooth Low Energy Connection State A.4. Device Battery Indicator: Remained battery state of the connected device In the case of the ratio is lower than 25%, “Battery is too low” Notification will appear. Samsung Confidential [11]...
- Page 12 Nothing selected until 3 seconds then it backs to translucent and menu buttons will be disappeared. D.1. Change Device: Device Select View will appear D.2. Set MARK: add User event mark D.3. Show/Hide STATUS Bar: show/hide STATUS Bar Samsung Confidential [12]...
- Page 13 BIH format(.hea/.dat, 16 format - only for exported by this app) can be loaded. If there is no folder stored signal files, check your system options like below. In case of Android OS, Internal Storage would be hidden. Samsung Confidential [13]...
- Page 14 Device Number and the first connection time. D.7. Show HRV View: shows HRV information view D.8. Show/Hide HR Trend View: show/hide HR Trend View HR Trend View shows HR trend and minimum/maximum HR for 1 Hour. Samsung Confidential [14]...
- Page 15 E.2.1. VLF: very low frequency power (0.00333 Hz to 0.040 Hz) E.2.2. LF: low frequency power (0.040 Hz to 0.150 Hz) E.2.3. HF: high frequency power (0.150 Hz to 0.400 Hz) ** During measure the HRV, minimize move. Samsung Confidential [15]...
- Page 16 It could be used to calculate distance of the S-PATCH and the host device. F.2. Nothing available: This will disconnect connected device and stay without any connection F.3. Cancel: This will back without any changes F.4. App version: This shows App’s version Samsung Confidential [16]...
- Page 17 G.7. Total Time Range Navigation: This supports the selection of the Small Time Range Navigation’s range on the total time range. H. Viewer Menu Button “BACK” button supports return of previous window as like as Android Device’s Cancel button. Other buttons are same as S-PATCH real-time signal display state. Samsung Confidential [17]...
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Page 18: How To Install S-Patch3
1) The electrodes and coin battery are disposable. Please observe local laws for disposal of electrodes and coin battery. 2) Please ensure user’s hands are clean and dry when handle the S-PATCH3 3) The body hair possibly causes contact problem which results a fault detection of physiological data. - Page 19 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. Samsung Confidential [19]...
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Page 20: Using And Operating S-Patch3
4. Using and Operating S-PATCH3 4.1 How to Use S-PATCH3 1) After connect the electrodes with S-PATCH3, peel the plastic on the backside of the electrodes. 2) Attach the S-PATCH3 on recommended position as drawn. 3) Push the power button longer than 3 seconds. - Page 21 7) Please touch the Menu Button located right bottom side like as below. 8) Menu Buttons will appear then touch “DEVICE” button Buttons will disappear if there is no selection for 3 seconds. 9) Connectable S-PATCH Devices will be added to the list. Samsung Confidential [21]...
- Page 22 Select the device to be connected. After pairing S-PATCH device, top-right side’s connection indicator will be updated, and ECG Signals will be shown as following as BLE transmission. Samsung Confidential [22]...
- Page 23 Above example means S-PATCH (3105) device’s signals are received since 2015 year January 1 day PM 1:30:47. Same name’s folder has detail data. Algorithm Result (Heart rate, Respiratory Rate and Heart rate variability) will be updated after valid signals are received for required time range for each algorithm. Samsung Confidential [23]...
- Page 24 Bottom navigation and swiping on signal graphs are able to move on the showing time. And HR, RR and HRV values are updated as following as the time. If the S-PATCH device is connected, received signal will be stored in background. Samsung Confidential [24]...
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Page 25: Specifications
If “BACK” button is pressed again during 1 second, one more confirmation is required. “YES” will terminate the app. “NO” will not. In case of using iOS, just push “HOME” button. 4.2 Specifications 4.2.1 S-PATCH3 Specifications Classification Name Description Performance... -
Page 26: Error Message And Alarm
And notification will appear with alarm or vibration as user ’s setting. (Mute setting woulddoes not make any alarm sound and vibration) 4.3.2 Abnormal signal detect In case of algorithm detects invalid signal, assume LEAD OFF state and show below. Samsung Confidential [26]... -
Page 27: Low Battery Mode
And alarm like below. All algorithms are not available. After valid signal is detected, it’s changed to LEAD ON state and algorithms are restarted. 4.3.3 Low Battery mode Battery state is updated on top-right of the STATUS bar. Battery Icon’s meaning is like below. Samsung Confidential [27]... -
Page 28: Low Remaining Storage
In the case of the ratio is lower than 10%, “Change Device’s Battery!” Notification will appear. 4.3.4 Low Remaining Storage If the remaining storage is under 10MB, caution will appear. Then make some more remaining storage. If not, signal would be lost. Samsung Confidential [28]... - Page 29 4.4 Maintenance For cleaning, gently wipe with a soft dry cloth after using the S-PATCH 3. Please attempt to keep S-PATCH3 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.
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Page 30: Labels And Packaging
5. Labels and Packaging 5.1 Labels 5.1.1 Label for Packaging 5.1.2 Label for module Front- side 2 Labels Rear-side 2 Labels Samsung Confidential [30]... -
Page 31: Packaging
The serial number that identifies the object. Date of manufacture Manufacturer Caution / Warning Instruction for User Manual Type of applied part Prescription only WEEE Mark Temperature limitation 5.2 Packaging 5.2.1 Package List Classifications Components Quantity S-PATCH3 module Electrodes Main Box Battery Manual Samsung Confidential [31]... -
Page 32: Package Units
5.2.2 Package Units 1) S-PATCH3 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 Samsung Confidential [32]... -
Page 33: Information On Emc
± 1kV for IEC 61000-4-4 hospital environment. input/output lines input/output lines ±1kV differential ±1kV differential Mains power quality should be Surge mode mode that of a typical commercial or IEC 61000-4-5 ±2kV common ±2kV common hospital environment. mode mode Samsung Confidential [33]... -
Page 34: Guidance And Manufacturer's Declaration - Electromagnetic Immunity
3 Vrms 3 Vrms frequency of the transmitter. 150 kHz to 150 kHz to Conducted RF 80MHz 80MHz IEC 61000-4-6 Recommended separation distance Radiated RF 3 V/m 3 V/m IEC 61000-4-3 80 MHz to 80MHz to 2.5GHz 2.5GHz Samsung Confidential [34]... -
Page 35: Recommended Separation Distances Between Portable And Mobile Rf Communications Equipment And The Eut
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. Samsung Confidential [35]... -
Page 36: Immunity And Compliance Level
6.5 Immunity and Compliance Level Immunity test IEC 60601 Test Level Actual Immunity Level Compliance Level Conducted RF 3Vrms 3Vrms 3Vrms IEC 61000-4-6 150kHz to 80MHz Radiated RF 3Vrms 3V/m 3V/m IEC 61000-4-3 80MHz to 2.5GHz Samsung Confidential [36]... -
Page 37: Guidance And Manufacturer's Declaration - Electromagnetic Immunity
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. Samsung Confidential [37]... -
Page 38: Fcc Compliance Statement
8. Product Life time and Warranty 8.1 Product Life time - S-PATCH3 is guaranteed to last for a minimum of two years. 8.2 Product Warranty - The warranty covers a year. -
Page 39: Company Introduction
Product damage due to improper storage Product damage due to improper usage 9. Company Introduction 9.1 Company Name and Address Company name: Samsung Electronics Co., Ltd. Address: 1-1, Samsungjeonja-ro, Hwaseong-si, Gyeonggi-do, 18448 Korea Tel : +(82) 31-8037-3533 e-mail: s.patch@samsung.com...