USER MANUAL Wearable Health Monitoring System (MODEL : S-PATCH3) Document No. : S-UM-01 (Rev. 0.2) Samsung Electronics Co., Ltd.
Revision History Revision Number Issue Date Rev.0.0 2016.12.28 Rev.0.1 2017.1.5 5.1 Label Update Rev.0.2 2017.2.9 5.1 Label Update Rev.0.2 2017.2.9 4.2.
Contents 1. 2. 3. Product Introduction .................................................................................................................................... 5 1.1 Introducing S-PATCH3 ......................................................................................................................... 5 1.2 Indication for Use .................................................................................................................................... 5 Cautions ...............
5. 4.3.2 Abnormal signal detect .................................................................................................................. 26 4.3.3 Low Battery mode .......................................................................................................................... 27 4.3.4 Low Remaining Storage ................................................................................................................ 28 Labels and Packaging .........................................
1. Product Introduction 1.1 Introducing S-PATCH3 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 body signal sensing module, ECG electrodes and mobile app viewer to monitor the signals.
) 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. 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.
2.4 Usage and Storage Conditions 2.4.1 Conditions for Usage 1) Temperature: 0℃-45℃(32℉ to 113℉) 2) Relative humidity: 10%-95%(non-condensing) 3) Atmospheric pressure: 700hPa-1060hPa 2.4.2 Conditions for Storage 1) Temperature: −20℃-70℃(-4℉ to 158℉) 2) Relative humidity: 10%-95%( non-condensing) 3) Atmospheric pressure: 400hPa-1500hPa 4) Keep the device in the case when it doesn't use. 2.4.
3. Components and Installation of S-PATCH3 3.
3.2 Accessory Components 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. DC 3V Coin Battery.
3.
A. STATUS Bar A.1. Elapsed Time: The elapsed time from the first signal receiving time A.2. Device ID: Connected S-PATCH Device’s ID 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.
서식 있음: 글꼴: (영어) Times New Roman, (한글) 바탕체 In the case of the ratio is lower than 10%, “Change Device’s Battery!” Notification will appear. 서식 있음: 글꼴: (영어) Times New Roman, (한글) 바탕체 B. C. D. ECG View Double Tapping on ECG View will toggle MONITORING and PAUSE mode. In PAUSE mode, it’s enabled that Scrolling by swipe gesture on ECG Graph. Scaling (magnification ratio changing 50 ~ 150%, by 10%) by zooming gestures is able for both modes. B.1. Measured ECG Signal: Measured ECG signals B.2.
D.4. ECG View’s Background: BLACK: black background, green signal PAPER: ECG Paper background, black signal D.5. Import from file: read signal data from stored file. S-PATCH format(*.sp) and MIT 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.
D.6. Export to file: Received Signal data automatically stored to device’s storage as formatted .sp (S-PATCH format). This button makes MIT BIH format file. The file name is automatically generated by based on the 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.
E. HRV View: shows HRV information E.1. Time Domain HRV E.1.1. AVNN: mean of all the intervals in ms E.1.2. SDNN: standard deviation all RRIs over the complete test duration in ms E.1.3. SDANN: standard deviation of the 5 min means in ms E.1.4. ASDNN: mean of the 5 min standard deviation in ms E.1.5. NN50: the number of RRI difference of successive RRIs greater than 50ms E.1.6. PNN50: NN50 as a percentage of all allowed RRIs E.1.7. RMSSD: root mean square of successive differences in ms E.1.8.
F. Device Select View: scanning S-PATCH devices nearby and show IDs. F.1. Devices: Scanned S-PATCH devices are shown. One of them is selected then connection will be tried. The number in bracket after S-PATCH name is the Device ID. RSSI is Received signal strength indication in a wireless environment, in arbitrary units. 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.
G. H. Signal Viewer G.1. File Name: Loaded File Name G.2. Total Time Range: Stored total signal’s range G.3. Left-side time of signal: Signal Viewer’s left side time G.4. Right-side time of signal: Signal Viewer’s right side time G.5. Near Signal Navigation: This shows signals of larger range than Signal Viewer. Swipe gesture will scroll the time range. G.6. Small Time Range Navigation: This supports specific time selection in small time range by touch.
The app shows as Landscape orientation as following as device’s orientation. 3.4 How to Install S-PATCH3 3.4.1 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. 4) Connect Electrodes to electrode connect hole in each side of S-PATCH3. 3.5 Precautions 1) The electrodes and coin battery are disposable.
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.
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. 4) Confirm that the LED is ON and OFF 3 times.
< ON > < OFF > 5) Put the Bluetooth mode to “ON” mode of user’s mobile device. 6) Please execute S-PATCH App. 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.
If the app has not yet proper permission to access the host device’s BLE, permission requesting messages will be shown like below. S-PATCH app uses BLE and storage of the host device. And BLE needs Location Permission, so, BLE, Location and Storage permissions are requested. If it’s denied one of them, the app could not receive and store signal data. 10) Select the device to be connected.
Received signal data is automatically stored to the host device’s storage as file under /SPATCH folder. The file and folder name is generated by S-PATCH device number and connection time. Above example means S-PATCH (3105) device’s signals are received since 2015 year January 1st 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.
12) Select “N/A” to finish recording on Device Selection 13) To load a stored signal, select “IMPORT” button through Menu-Button and choose the file. Then it will be loaded like below. 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.
“BACK” button of Menu Buttons will back. 14) To finish S-PATCH app, push “BACK” button of Android device. To prevent unintended finish, below message is shown. 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.
4.3 Error Message and Alarm 4.3.1 Device Disconnection If the BLE is disconnected on receiving signal, BLE connection indicator is updated. 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.
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.
In the case of the ratio is lower than 25%, “Battery is too low” Notification will appear. 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.
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.
5. Labels and Packaging 5.1 Labels 5.1.1 Label for Packaging 5.1.
- 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 Temperature limitation 5.2 Packaging 5.2.
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.
6. Information on EMC 6.1 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 Group 1 The EUT uses RF energy only for its internal function.
Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11 Power frequency (50/60Hz) magnetic field IEC 61000-4-8 <5% Uт (>95% dip in Uт) for 0.5cycle 40% Uт (60% dip in Uт ) for 5 cycle 70% Uт (30% dip in Uт) for 25 cycle <5% Uт (<95% dip in Uт ) for 5 s 3 A/m <5% Uт (>95% dip in Uт) for 0.
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 a survey, should be less than the compliance level in b each frequency range. Interference may occur in the vicinity of equipment marked with the following symbol : NOTE 1) At 80MHz and 800MHz, the higher frequency range applies.
Separation distance according to frequency of transmitter [m] Rated maximum output power of transmitter [W] 150kHz to 80MHz 800MHz to 2.5GHz 80MHz to 800MHz E1=3V/m E1=3V/m V1=3Vrms 0.01 0.116 0.1166 0.1 0.368 0.3687 1 1.166 1.1660 10 3.687 3.6872 100 11.660 11.6600 0.2333 0.7378 2.3333 7.3785 23.
6.6 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.
7. 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.
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.
