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.
Revision History Revision Number Rev.0.0 2020.01.20 Rev.0.1 2020.01.28 Rev.0.2 2020.02.07 Rev.0.3 2020.02.14 Issue Date Samsung Confidential Contents of Revision Established by Manufacturer’s User Manual Policy Section 5.6, Updated specification of external device connection Section 4.2, Deleted applied part description Section 5.
Table of Contents 1. 2. 3. 4. 5. 6. 7. Product Introduction ..................................................................................................................................................... 5 1.1. Introduction........................................................................................................................................................... 5 1.2. Indications for Use & Intended Use ...............................................................................
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 .................................................................
1. Product Introduction 1.1. Introduction The S-PATCH Wearable health recording system is an electrocardiogram(ECG) recording system designed to record, transfer and display ECG data collected from devices worn on adult patient’s body. The system consists of a Sensor device, a Cradle, PC software, a Mobile app and associated accessories (electrodes, coin battery, USB cable, installation USB flash drive). The Sensor device records the ECG signals continuously from the patients.
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.
2.3. Usage and Storage Conditions 2.3.1. 1) 2) 3) Conditions for Usage Temperature: 5℃- 40℃(41℉ to 104℉) Relative humidity: 10%-95% (non-condensing) Atmospheric pressure: 700hPa-1060hPa 2.3.2. 1) 2) 3) 4) Conditions for Storage Temperature: −25℃- 70℃ (-13°F to 158°F) Relative humidity: 10% to 95% (non-condensing) Atmospheric pressure: 700hPa-1060hPa Keep the device in the case when it doesn't use. 2.3.3.
⑥ ⑦ Label ⑧ Name Description ① Battery module Coin battery inset module ② Sensing module ECG Sensing module ③ Connect Cable Connection between Battery module and Body2 ④ Power Button Power On/Off button ⑤ LED LED Lamp to indicate the device states ⑥ Electrode connect hole Holes for ECG electrodes connecting ⑦ Product code Product Serial Number & QR code ⑧ Cradle connection pins 10-pins for connecting to Cradle 4.1.2.
; Do not remove ⑥Ferrite core from the USB cable. It may cause EMI(Electromagnetic Interference) problem 4.1.3.
Patient ④ ECG signal Graph ECG signal graph chart display - Zoom In/Out, Cursor, Marker ⑤ Analysis Heart Rate Table ⑥ Heart Rate Graph Heart rate graph chart display 4.1.4.
Label Name ① Electrode ② Battery Description Multi-purpose recording electrodes with sticky gel feature (high performance adhesive and foam backing) Note: Use the FDA registered Electrode. Power supply for S-PATCH. DC 3V Coin Battery. Note: Use the certified battery by IEC 60086-4 or UL1642 4.3. How to Start S-PATCH 4.3.1. Required Environment o o o o Windows 10 installed PC - 200MB free disk space or greater - Minimum High Speed USB 2.
2) Connect the Cradle to the PC USB Port. Then the LED of the Cradle will turn red color 3) Plug the Sensor device into the Cradle o Open the sliding door on the bottom of the Sensing module to connect the Cradle o Attach the Sensing module to the Cradle. Then the LED of the Cradle will turn green color 4) Execute S-PATCH management (S-PATCH.
o o o User name: Admin Password: (Password provided separately in the packing box) The following menu will appear. Create new account and click ‘Add’ and close window. Make sure that password should contain 8 to 15 characters, at least one upper case letter, at least one lower case letter and at least one special case characters.
4.3.3. Sensor device Setup 1) Insert battery to the battery module of Sensor device First, release the screw on the battery module using screw driver. Second, open the upper case of battery module and insert the battery. Lastly, close the case and lock the screw. ; 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.
4.4. 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 Sensor device is not likely to be used for long time. 3) Please ensure user’s hands are clean and dry when handle the Sensor device 4) The body hair possibly causes contact problem which results a fault detection of physiological data. Excessive body hair should be removed several hours before use.
Sensing module Battery module 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. 2) Install the Mobile app (S-PATCH mobile app.apk) on the smart phone.
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.
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” and “S-Patch is not working” S-PATCH Mobile app uses BLE and storage of the host device.
Permission, so, BLE, Location and Storage permissions are requested. If it’s denied one of them, the Mobile app could not receive the status data. 5.1.3. 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.
o ECG Graph Preview Navigation Button: Move recorded data along X-axis of time o ECG Graph Zoom - Mouse scroll: X/Y axis simultaneous zoom in/out - Alt + mouse scroll: Y axis zoom in/out - Ctrl + mouse scroll: X axis zoom in/out - Shift + mouse left click area selection: selected area zoom in/out - Zoom in limit area: X axis – 1sec / Y axis – 2mV - Zoom out limit area: X axis – Full recorded time / Y axis – 100mV Cursor - Create Cursor: Menu-View-Cursor - Cursor1, 2 and difference will be displayed
5.3. Specifications S-PATCH Specifications Classification Name Type Performance Channel Communication with mobile device DC Offset Tolerance Circuitry ADC Resolution ADC Sampling Rate Input Impedance Power Power Supply Requirements Battery Life F/W version CPU Software BLE App(Android) Weight (Exc. Battery) Physical Dimension (Battery module,2) Characteristics Dimension (Connect Cable) Bluetooth Radio Modulation Communication Radio Frequency Max.
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. Press “OK” to turn off the pop-up. After valid signal is detected, it’s changed to LEAD ON state. Figure 1 Figure 2 5.4.3.
Figure 3 Figure 4 Figure 5 5.5. Maintenance For cleaning, gently wipe with a soft dry cloth after using the Sensor device. Please attempt to keep the Sensor device dust free. The Sensor device is water resist. 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. 5.6. Specification of External Device connection The Sensor device is connected to the Android Application.
2) Specification of Network connection Communication protocol: the protocol between the Sensor device and the Mobile app is a BLE central (Mobile) – peripheral (Sensor device) communications and they communication with security requirements defined in the BLE Protocol Stack. C.
6. Labels and Packaging 6.1. Labels 6.1.1. Label for Packaging PRODUCT NAME Wearable Health Recording System MODEL NAME S-PATCH RATED VOLTAGE 3.0 V d.c. (Lithium coin battery) FCC ID A3LSPATCH Dimension (Sensing module) 29 x 5.25 mm [Diameter x Height] IP Grade IP22 Dimension (Battery module) 29 x 5.8 mm [Diameter x Height] Serial Number (Sensor device) Dimension (Connect cable) 110 ± 10 mm Serial Number (Cradle) Dimension (Cradle) 44.5 x 19.
6.1.4. Descriptions of the visual symbols of the label No. 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 CF applied part 7 Prescription only 8 WEEE Mark 9 Keep Dry 10 Non-ionizing radiation 11 MR unsafe 6.2.
7. 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 RF Emissions CISPR 11 RF Emissions CISPR 11 Compliance Electromagnetic environment - Guidance Group 1 The S-PATCH uses RF energy only for its internal function.
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.
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.
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 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.
Supplier's Declaration of Conformity 47 CFR § 2.1077 Compliance Information Unique Identifier: RD28 Responsible Party – U.S. Contact Information Company: Samsung Semiconductor Inc. Street Address : 3655 N 1st St City, State : San Jose, CA Zip Code : 95134 Contact information : Kevin Lee / email : lee.kevinj@samsung.com / 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.
