Subscribe to Our Youtube Channel
Related Manuals for Wellysis S-Patch Ex
Summary of Contents for Wellysis S-Patch Ex
- Page 1 Solution Version: v.1.5.1 Last Updated: 2022.05.13 USER MANUAL Wearable ECG Patch (MODEL: S-Patch Ex) Document No: WSE-UM-01 (Rev. 0.5) Wellysis Corp. 8F, 425 Teheran-ro, Gangnam-gu, Seoul, Republic of Korea...
-
Page 2: Table Of Contents
Compatible Software ....................12 5.2.1 S-Patch Ex Mobile Application ................12 5.2.2 3rd-Party Cloud-Based ECG Viewing Platform ............. 12 S-Patch Ex Operating Instructions (for healthcare professional) ..........13 Preparation ........................ 13 6.1.1 Inserting the battery..................13 6.1.2 Patient skin preparation ..................13 6.1.3... - Page 3 10.2.2 Information transmission .................. 28 10.3 Security Controls ......................28 10.4 End of support ......................30 10.5 Manufacturer’s Disclosure Statement for Medical Device Security ........31 11 Symbols ..........................36 12 Expected Service Life and Warranty ..................37 12.1 Expected Service Life ....................37 12.2 Warranty........................
-
Page 4: Product Introduction
The S-Patch Ex is intended to be used by medical professionals in accordance with the user manual. The S-Patch Ex can be worn by patient in either a healthcare setting or at home. Certain actions (such as replacement of battery or electrode) can be performed by a patient at directions from a medical professional and in accordance with the user manual. -
Page 5: Indications For Use
The device is intended for use on general care patients who are 18 years of age or older for ECG and HR data collection purposes only. The data recorded by the S-Patch Ex wearable ECG patch can be uploaded wirelessly via a wellness app to a compatible 3 party cloud-based ECG viewing platform for further analysis and interpretation by qualified clinicians. -
Page 6: Safety Information
6) Do not drop or bump with excessive force. 7) After completing the testing, peel the S-Patch Ex off the skin. Prolonged use of electrodes may cause skin irritation. Discontinue use and consult your healthcare provider if skin irritation occurs. -
Page 7: Emc
3.3.3 1) DO NOT expose the device to strong electromagnetic fields. 2) Use of S-Patch Ex adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this device and the other equipment should be observed to verify that they are operating normally. -
Page 8: Patch Ex Components
S-Patch Ex Components 4.1 Components list < Front of S-Patch Ex > < Rear of S-Patch Ex > Name Description Battery Unit Containing a compartment for a coin battery Power Unit Containing main PCB, power button and LED Cable Cable between two Battery and Power Units... - Page 9 < Outer Carrying Case > < Inner Carrying Case > Name Description Carrying Case Keep the S-Patch Ex when it is not being used...
-
Page 10: Components Dimensions
1) Temperature: −25℃ - 70℃ (-13°F to 158°F) 2) Relative humidity: 10% - 95% (non-condensing) 3) Atmospheric pressure: 700hPa - 1060hPa NOTE 1) Keep the S-Patch Ex in the carrying case when it is not being used. 2) Store electrodes according to electrode manufacturer’s recommendations. -
Page 11: Product Interoperability
Product Interoperability The S-Patch Ex wearable ECG patch works with S-Patch Ex Mobile App, compatible 3rd-party ECG electrodes, lithium coin battery and a cloud-based ECG viewing platform. These compatible accessories and software are not part of the S-Patch Ex wearable ECG patch. -
Page 12: Compatible Software
No. WSE-UM-02) 5.2.2 3rd-Party Cloud-Based ECG Viewing Platform A 3rd-Party Cloud-Based ECG Viewing Platform is used to display ECG and HR data generated by the S-Patch Ex and transmitted via the Mobile App for further analysis and interpretation by qualified clinicians. -
Page 13: Patch Ex Operating Instructions (For Healthcare Professional)
2) Clean skin in target area with soap and water, or with an alcohol wipe. 3) Dry skin completely. NOTE Do not apply anything to skin prior to applying the S-Patch Ex, such as lotions, oils, and sprays. Caution Do not apply S-Patch Ex over open wounds, lesions, infected or... -
Page 14: Instruction For Patient
Clause 7. ‘S-Patch Ex Operating Instructions (for patient)’ 6.2 Turning On S-Patch Ex 1) On the Power Unit of the S-Patch Ex, press and hold the power button for 3 seconds. 2) When the device is turned on, the LED light (i.e., the arrow) blinks 3 times in blue color and then stays off. -
Page 15: Applying S-Patch Ex To Patient Body
6.4 Applying S-Patch Ex to Patient Body 1) Apply S-Patch Ex with electrodes to patient’s chest per instructions below: Target and acceptance locations for placement of the S-Patch EX electrodes: Power Unit (with Power Button and LED Light): As shown in green shaded area in the figure above. -
Page 16: Preparing Returned S-Patch Ex For Next Patient
NOTE Patient can be sent home wearing the S-Patch EX after the healthcare provider explains the proper use of the device. 6.6 Preparing Returned S-Patch Ex for Next Patient NOTE User may need to insert a battery to perform this step if the battery has been removed by the previous patient. -
Page 17: Cleaning S-Patch Ex
6.7 Cleaning S-Patch Ex The S-Patch Ex is a reusable device and requires cleaning after each use. For best results, the following cleaning procedures are recommended. Confirm the used battery and electrodes were removed from the patch, and follow the instructions below when cleaning the S-Patch Ex. -
Page 18: Patch Ex Operating Instructions (For Patient)
Following instructions in Section 7.2.2 to remove the S-Patch Ex. Following instructions in Section 6.1.2 (Skin Preparation), Section 6.3 (Connecting Electrodes) and Section 6.4 (Applying S-Patch Ex) to reapplying S-Patch Ex with new electrodes back to chest. See the Mobile App user manual (Doc. No. WSE-UM-02) Section 5.2 for resuming the S-Patch Ex. -
Page 19: Returning S-Patch Ex
7.3 Returning S-Patch Ex Wipe clean the S-Patch Ex (i.e., Power Unit, Battery Unit and cable) patch with a soft, dry cloth, using the carrying case to return it to the clinic. Troubleshooting Circumstances Recommended Action I cannot connect Bluetooth Please check if Bluetooth is enabled on the smartphone. -
Page 20: Specifications
Specifications 9.1 S-Patch Ex Specifications Specification Description Type CF-Type Performance Channel Single channel Communication Above BLE 4.2 with Mobile device DC Offset +/- 300mV Tolerance Circuitry ADC Resolution 12 bits ADC Sampling 256 Samples/Second Rate Input Impedance >100 MΩ Power Supply... -
Page 21: Fcc Compliance (Fcc Id: 2Aydns-Patch)
- These device & its accessories must accept any interference received, including interference that may cause undesired operation. This equipment generate radio frequency energy. No modification of the S-Patch Ex is allowed. This user could lose the authority to operate this equipment if an unauthorized change or modifications is made. -
Page 22: Guidance And Manufacturer's Declaration - Electromagnetic Emissions
EUT should assure that it is used in such an environment. Immunity test Compliance Electromagnetic environment - Guidance The S-Patch Ex uses RF energy only for its internal RF Emissions function. Therefore, its RF emissions are very low Group 1... -
Page 23: Guidance And Manufacturer's Declaration - Electromagnetic Immunity
9.4 Guidance and Manufacturer’s Declaration – Electromagnetic Immunity The S-Patch Ex is intended for use in the electromagnetic environment specified below. The users of the S-Patch Ex should assure that it is used in such an environment. IEC 60601 Compliance... - Page 24 IEC 60601 Compliance Electromagnetic environment - Immunity test Test level level Guidance Power Power frequency magnetic fields frequency should be at levels characteristic of (50/60 Hz) 30 A/m 30 A/m a typical location in a typical magnetic field commercial or hospital environment IEC 61000-4-8 NOTE 1) At 80MHz and 800MHz, the higher frequency range applies.
-
Page 25: Recommended Separation Distances Between Portable And Mobile Rf Communications Equipment And The S-Patch Ex
9.5 Recommended separation distances between portable and mobile RF communications equipment and the S-Patch Ex The S-Patch Ex is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The users of the S-Patch Ex can help prevent... -
Page 26: Security Information
10.1.2 Data flow The S-Patch Ex device is used to collect ECG and HR data of the user via the bio- processor. Besides, it is also equied an IMU sensor to collect tho motion data which is used for the R&D purpose only. -
Page 28: Sensitive Information Stored And Transmitted
Implementation applications and S-Patch Ex device. Use mode 1 and level 4 for secure pairing of mobile BLE secure pairing applications and the S-Patch Ex device. Use just works SC002 mode "BLE secure pairing" with strong key pairing and with ECDSA authentication. - Page 29 Flash encrypted Measurement and device ID data should be encrypted SC019 storage block in flash storage of the S-Patch Ex device. SC020 Secure boot Implement Nordic secure boot mechanism on device. Brute-force Device connection module and broadcasting should be...
-
Page 30: End Of Support
10.4 End of support The S-Patch Ex system patient and customer support includes a call center, vendor web portals, and service support personnel. The information that flows through this support infrastructure will be processed and analyzed for security concerns at the legal manufacturer. -
Page 31: Manufacturer's Disclosure Statement For Medical Device Security
Manufacturer Document ID Document Release Date Medical Electrical Equipment Wellysis Corp. WSE-UM-01 2022-08-23 Device Model Software Revision Software Release Date S-Patch Ex 1.5.1 2020-12-10 Manufacturer Company Name Manufacturer Contact Information Representative Wellysis Corp. 8F, 425 Teheran-ro, Gangnam-gu, Seoul Contact Representative Name/Position Information info@wellysis.com... - Page 32 Manufacturer Disclosure Statement for Medical Device Security – MDS SECURITY CAPABILITIES Yes, No, Refer to Section 2.3.2 of HIMSS/NEMA HN 1-2013 standard for the proper interpretation of N/A, or information requested in this form. See Note AUTOMATIC LOGOFF (ALOF) The device's ability to prevent access and misuse by unauthorized users if device is left idle for a period of time.
- Page 33 Manufacturer Disclosure Statement for Medical Device Security – MDS CSUP 1. It is possible to update firmware of device by nRF connect application on mobile phone notes: HEALTH DATA DE-IDENTIFICATION (DIDT) The ability of the device to directly remove information that allows identification of a person. Does the device provide an integral capability to de-identify private data? ..........
- Page 34 Manufacturer Disclosure Statement for Medical Device Security – MDS 12-1 Does the device support user/operator-specific username(s) and password(s) for at least one user? 12-1.1 Does the device support unique user/operator-specific IDs and passwords for multiple users? ..............................12-2 Can the device be configured to authenticate users through an external authentication service (e.g., MS Active Directory, NDS, LDAP, etc.)? ....................
- Page 35 Manufacturer Disclosure Statement for Medical Device Security – MDS 15-11 Can software or hardware not authorized by the device manufacturer be installed on the device without the use of tools? 1. Standard names: FIPS 197, FIPS 140-3, FIPS 180-4, FIPS 186-4, FIPS 180-3 and SEC 2 SAHD 2.
-
Page 36: Symbols
11 Symbols Label Symbol Description The serial number that identifies the object. The lot number that identifies the object. Date of manufacture Manufacturer Prohibition Warning Caution Instruction for User Manual CF applied part Prescription only WEEE Mark Keep Dry Temperature limit Humidity limitation Non-ionizing radiation MR unsafe... -
Page 37: Expected Service Life And Warranty
The product is guaranteed to be free of manufacturing defects with a limited warranty for 1 year from the date of purchase. This warranty is valid only if the S-Patch Ex is used in accordance with the manufacturer’s instructions. This warranty will not apply: If damage or malfunction results from negligence or improper use, including but ... -
Page 38: Contact Information
13 Contact information Wellysis Corp. 8F, 425 Teheran-ro, Gangnam-gu, Seoul, Republic of Korea Tel) +82-1800-2830 This crossed-out wheeled bin symbol indicates that waste electrical and electronic products (WEEE) should be disposed of separately from the municipal waste stream. -
Page 39: Appendix I. Acronyms
Appendix I. Acronyms Acronym Full Text Electrocardiograph Heart Rate Heart Rate Variability...
Need help?
Do you have a question about the S-Patch Ex and is the answer not in the manual?
Questions and answers