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Related Manuals for Wellysis S-Patch Ex
Summary of Contents for Wellysis S-Patch Ex
- Page 1 USER MANUAL Wearable Health Monitoring System (MODEL: S-Patch Ex) Document No: WS-UM-01 (Rev. 0.1) Wellysis Corp. 1111ho, 311, Gangnam-daero, Seocho-gu, Seoul, Republic of Korea...
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Page 2: Product Introduction
ECG and HR signals, and streams the digitized signals to a mobile gateway device equipped with S-Patch Ex App. At the end of each ECG recording session, patients can upload their data to a secure cloud portal via their mobile device connection. After the data upload takes place, physicians can access and review their patients’... -
Page 3: Non-Ionizing Radiation
WEEE Mark Keep Dry Temperature limit Humidity limitation Authorized European Representative address 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. Non-ionizing radiation MR unsafe 1.4 Target treatment group and diseases Contents Description... - Page 4 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.
- Page 5 2) Remove the battery if the device is not likely to be used for an extended period of time. 3) Please ensure hands are clean and dry when handling the S-Patch Ex 4) Excessive body hair may cause noise in the recording.
- Page 6 Changes or modifications to this equipment may cause harmful interference unless the modifications are expressly approved in the instruction manual. This user could lose the authority to operate this equipment if an unauthorized change or modifications is made. Components and Installation of S-Patch Ex 3.1 Main Device Components...
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Page 7: Accessory Components
< Front of S-Patch Ex > < Rear of S-Patch Ex > 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 8 (high performance adhesive and foam backing) Electrode(single use) Material: PE foam, Ag/AgCl sensor, Nickel plated brass, Solid hydro gel Power supply for S-Patch Ex. DC 3V Coin Battery. Battery Battery is replaceable. The S-Patch Ex Web is a cloud-based server which...
- Page 9 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 S- Patch Ex mobile app download link (https://play.google.com/store/apps/details?id=com.wellysis.spatchcardio.app& hl=en_US&gl=US https://apps.apple.com/kr/app/s-patch- cardio/id1496099268?l=en). The device must support Bluetooth Low Energy.
- Page 10 2) Confirm that the LED blinks ON 1 time and OFF for 5 seconds. 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.
- Page 11 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. Select Region and entering Organization Code and Device S/N...
- Page 12 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.
- Page 13 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.
- Page 14 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. [14]...
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Page 15: Specifications
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 4.3.1 S-Patch Ex Specifications Classification Name Description Type CF-Type Performance Channel Single channel Communication with... -
Page 16: Error Message
* Contact email : spatch.cardio@ wellysis.com When no data has been recorded because No data to there is an error with time of gateway Reinstall App send device and the test ends as soon as it has... - Page 17 network status [17]...
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Page 18: Maintenance
4.5 Maintenance For cleaning, gently wipe the S-Patch Ex with medical grade disinfectant. DO NOT immerse the S- Patch Ex in liquid. The S-Patch Ex is water resistant, but should be kept dry. This device does not have user serviceable components. - Page 19 (Size: 100 x 55 mm) 5.1.2 Label for module (Size: Φ26mm) <Rear-side Label> 5.2 Packaging 5.2.1 Package List Classifications Components Quantity S-Patch Ex module Main Box Electrodes (4 Electrodes are in the 1 plastic bag) Quick Manual [19]...
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Page 20: Information On Emc
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. - Page 21 Electromagnetic environment - Guidance Test level level Portable and mobile RF communications equipment should be used no closer to any part of the S-Patch Ex, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.
- Page 22 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. 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.
- Page 23 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.
- Page 24 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. IEC 60601 Compliance Electromagnetic environment - Immunity test...
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Page 25: Manufacturer Information
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. 1111ho, 311, Gangnam-daero, Seocho-gu, Seoul, Republic of Korea (Zip code: 06628) Tel: +8218002830 Fax: +8225201590 Emergo Europe B.V.
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