USER MANUAL Wearable Health Monitoring System (MODEL: S-Patch Ex) Document No: WS-UM-01 (Rev. 0.1) Wellysis Corp.
1 Product Introduction 1.1 Introducing S-Patch Ex The S-Patch Ex is a light-weight electrocardiogram (ECG) and heart rate (HR) monitoring device with accompanying software. The S-Patch Ex operates wirelessly, and due to its compact size it is unobtrusive during daily activity. The S-Patch Ex continuously measures ECG and HR signals, and streams the digitized signals to a mobile gateway device equipped with S-Patch Ex App.
8 WEEE Mark 9 Keep Dry 10 Temperature limit 11 Humidity limitation 12 Authorized European Representative address 13 The CE symbol indicates that this product complies with the European Directive for Medical Devices 93/42/EEC as amended by 2007/47/EC as a class IIa device. 14 Non-ionizing radiation 15 MR unsafe 1.
2 Cautions 2.1 General 1) Store in climate controlled environments (parameters specified in section 1.4) 2) Since this product is a medical device, instructions are required to properly dispose of it. Contact the distributor or manufacturer for such instructions 3) Contact the manufacturer if there are any problems with product functionality. 4) Reuse of the electrodes is prohibited in any circumstances due to the risk of infection. 5) Prolonged use of electrodes may cause skin irritation.
2.4.2 Conditions for Storage 1) Temperature: −25℃- 70℃ (-13°F to 158°F) 2) Relative humidity: 10%-95% (non-condensing) 3) Atmospheric pressure: 700hPa-1060hPa 4) Keep the device in the case when it doesn't use. 2.4.3 Conditions for Cleaning 1) Disinfect by wiping with standard hospital disinfectant 2) DO NOT immerse device in liquid 2.4.4 Conditions for Usage and Storage of Electrode 1) Temperature: −10℃- 40℃ (14°F to 104°F) 2.5 Use of Device 1) The electrodes and coin battery are disposable.
2.7.1 MR-unsafe! Do not expose the device to a magnetic resonance (MR) environment. 1) The device may present a risk of projectile injury due to the presence of ferromagnetic materials that can be attracted by the MR magnet core. 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 2.7.
< Front of S-Patch Ex > < Rear of S-Patch Ex > Label Name Description 1 Main Body1 Coin battery inset module 2 Main Body2 Main PCB module 3 Connect Cable Cable between two main bodies 4 Power Button Power On/Off button 5 LED LED Lamp to indicate the states 6 Electrode connect Holes for ECG electrodes connecting hole 3.
Labe l 1 Name Description Electrode(single use) Model name: HR-OP42 Dimension: 43Ø Multi-purpose monitoring electrodes with sticky gel feature (high performance adhesive and foam backing) Material: PE foam, Ag/AgCl sensor, Nickel plated brass, Solid hydro gel 2 Battery 3 S-Patch Ex Web Power supply for S-Patch Ex. DC 3V Coin Battery. Battery is replaceable. The S-Patch Ex Web is a cloud-based server which stores the encrypted ECG data 3.3 Material No.
3.4 How to Install S-Patch Ex 3.4.1 Installing S-Patch Ex 1) Download the S-Patch Ex App (Android 8 and above /iOS 12 and above) from SPatch Ex mobile app download link (https://play.google.com/store/apps/details?id=com.wellysis.spatchcardio.app& hl=en_US&gl=US or https://apps.apple.com/kr/app/s-patchcardio/id1496099268?l=en). The device must support Bluetooth Low Energy. 2) Install the downloaded file on user’s mobile device.
4 Using and Operating S-Patch Ex 4.1 Turning S-Patch Ex on and Positioning it on Body 1) Push and hold the power button for 3 second. 2) Confirm that the LED blinks ON 1 time and OFF for 5 seconds. On Off 3) Make sure Bluetooth is enabled on the mobile device. 4) After connecting the electrodes with S-Patch Ex, peel off the plastic covers from the backside of the electrodes. 5) Attach the S-Patch Ex according to the recommended position as shown below.
4.2 S-Patch Ex ECG Test with Smart Phone 1) Connecting S-Patch Ex Device to the App. 1-1) Start S-Patch Ex App from the mobile device. 1-2) Enter the Organization Code as shown below to connect S-Patch Ex to the mobile device. a.
b. Connecting S-Patch Ex Device Note: Contact the system administrator if the Organization Code is unknown Note: S-Patch device number is printed on the back of the device 1-3) Verify that User’s ECG graph, HR and HRV can be viewed on the screen.
2) Logging Symptoms 2-1) Click on ADD SYMPTOM button to log symptoms into Patient Diary. 2-2) Entering Patient Diary (1) Click on Add new diary button to create a new Patient Diary. (2) Enter start and end date of the diary event. (3) Enter start date/time of the diary event. (4) Enter end date/time of the diary event. (5) Click on “Add symptom” button to choose a symptom from the list. (6) Click on “Select activity” button to specify what activity was being performed when the symptom occurred.
3) Pausing and Resuming Test 3-1) Click on the “Pause Test” button in my status page to temporarily pause the test. 3-2) Click “Restart Test” to resume. 4) Completing Test Click on the “End Test” button in my status page to complete the test.
5) Sending Data For analysis of the test the ECG data needs to be sent to S-Patch Ex Web. 5-1) Click Send Data button. 4.3 Specifications 4.3.
Physical Characteristics IMU Memory App(Android/iOS) Language ICM-42605 W25M02GVZEIG ( 256MB ) 8 and above / 12 and above English, Korean iPhone - 6, 6Plus, 6s, 6sPlus, 7, 7Plus, 8, 8Plus, XR, SE, SE2, 11, 11Pro, 12, 12Pro Optimized mobile devices Samsung – Galaxy A7, A9, A9Pro, A30, A50, A21, A31, A51, A90-5G, Note9, Note10, Note10Plus, Note20, Note20Ultra, S9, S9Plus, S10, S10Plus, S20, S20Plus, S20Ultra Weight(Exc.
network status [17]
4.5 Maintenance For cleaning, gently wipe the S-Patch Ex with medical grade disinfectant. DO NOT immerse the SPatch Ex in liquid. The S-Patch Ex is water resistant, but should be kept dry. This device does not have user serviceable components. Do not disassemble, crush, puncture, short external contacts or circuits, dispose of in fire or water. 4.6 Specification of External Device Connection The S-Patch Ex connects to an application running on a mobile device A.
5 Labels and Packaging 5.1 Labels 5.1.1 Main Label (location: under the back of the box) (Size: 100 x 55 mm) 5.1.2 Label for module (Size: Φ26mm) 5.2 Packaging 5.2.
5.2.2 Package Units 1) S-Patch Ex module Main module. 2) Electrodes 4 Electrodes are in the 1 plastic bag. 3) Manual Korean or English ** If users request, the wellysis can provide the user manual in the requested language 5. Information on EMC 5.1 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.
5.3 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.
symbol : 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. 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.
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. NOTE 1) At 80MHz and 800MHz, the separation distance for the higher frequency range applies. NOTE 2) These guidelines may not apply in all situations.
5.6 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.
6. Expected Service Life time and Warranty 6.1 Product Warranty - The product is guaranteed to be free of manufacturing defects and has a limited warranty for 1 year from the date of purchase. Damage or malfunction of the device to the following conditions are excluded from the warranty: Normal wear and tear of the product from normal daily usage Product damage due to improper storage Product damage due to improper usage 7. Manufacturer Information Wellysis Corp.
