9
< Outer Carrying Case >
< Inner Carrying Case >
No.
Name
Description
1
Carrying Case
Keep the S-Patch Ex when it is not being used
Page 1: ...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: ...trodes 14 6 4 Applying S Patch Ex to Patient Body 15 6 5 Connecting to Mobile App 15 6 6 Preparing Returned S Patch Ex for Next Patient 16 6 7 Cleaning S Patch Ex 17 7 S Patch Ex Operating Instructions for patient 18 7 1 Operate S Patch Ex 18 7 1 1 Optional Logging symptoms 18 7 1 2 Optional Removing and Reapplying S Patch Ex 18 7 2 Test Completion 18 7 2 1 Auto Completion 18 7 2 2 Removing S Patc...
Page 3: ...ntrols 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 37 13 Contact information 38 Appendix I Acronyms 39 ...
Page 4: ...nterpretation by qualified clinicians 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 Product Name ...
Page 5: ... the ECG and HR data at home and in healthcare settings 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 3rd party cloud based ECG viewing platform for further analysis and interpretation by qualifi...
Page 6: ...be used for each use 5 Do not place the device on top of excessive body hair Excessive body hair may cause noise in the recording Body hair should be removed prior to placement of the device 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 prov...
Page 7: ...y 3 Use of accessories other than those specified or provided in Section 5 could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation 4 Portable RF communications equipment including peripherals such as antenna cables and external antennas should be used no closer than 30 cm 12 inches to any part of the S Patch Ex in...
Page 8: ... Unit Containing a compartment for a coin battery 2 Power Unit Containing main PCB power button and LED 3 Cable Cable between two Battery and Power Units 4 Power Button Power On Off button 5 LED LED light to indicate device states 6 Electrode connection ports Connection ports for attaching compatible ECG electrodes ...
Page 9: ...9 Outer Carrying Case Inner Carrying Case No Name Description 1 Carrying Case Keep the S Patch Ex when it is not being used ...
Page 10: ... 1Conditions for Usage 1 Temperature 5 45 41 to 113 2 Relative humidity 10 95 non condensing 3 Atmospheric pressure 700hPa 1060hPa 4 3 2Conditions for Storage Transport 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 ma...
Page 11: ...e compatible ECG electrodes and batteries are not included in the package of the S Patch EX They need to be purchased separately Followings are an example of compatible accessories Electrode Battery No Name Description 1 ECG Electrode single use Multi purpose monitoring electrodes with sticky gel feature high performance adhesive and foam backing Model name HR OP42 Dimension 43Ø Material PE foam A...
Page 12: ... Patch Ex ECG patch and transfer the data to any compatible 3rd party cloud based ECG data viewing platform Please find the detailed description in the S Patch Ex Application user manual Doc No WSE UM 02 5 2 23rd 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 f...
Page 13: ...ronmental conditions i e extremely high temperature high pressure high humidity etc 6 1 2Patient skin preparation 1 Optional If excessive body hair is present on the target location for wearing the patch shave the area CAUTION Do not place the device on top of excessive body hair Excessive body hair may cause noise in the recording Body hair should be removed prior to placement of the device 2 Cle...
Page 14: ...se 3 Safety Information 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 6 3 Connecting Electrodes 1 Prepare two electrodes and connect each electrode to an electrode connection...
Page 15: ...pple line but below the clavicle are acceptable Battery Unit As shown in blue shaded area in the figure above Target and acceptable placement is defined as Electrode shall be placed on the left side of the midsternal line Target diagonal to Power Unit any horizontal position to the left of the midsternal line is acceptable Electrode vertical position can be placed below the Power Unit Target below...
Page 16: ...perform this step if the battery has been removed by the previous patient 1 Power off the S Patch device by pressing and holding the power button for 10 seconds 2 With the power off press and hold the power button for 10 seconds after 10 seconds LED will flash in blue and the device will restart When the LED turns red release the button 3 When S Patch powers back on it is reset and ready for use b...
Page 17: ...ch and follow the instructions below when cleaning the S Patch Ex Use a disinfecting wipe such as Super Sani Cloth to clean all S Patch Ex surfaces thoroughly Do not get excess liquid in any hole or opening on the device NOTE Please use the EPA registered disinfecting wipes When all surfaces are dry store the S Patch Ex in the carrying case Follow local laws and facility guidelines for the disposa...
Page 18: ...d 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 7 2 Test Completion 7 2 1Auto Completion The ECG test automatically completes once it reaches the end of the prescribed duration The patient receives Test Ended notification on the Mobile App and the ECG and HR data for...
Page 19: ...e replace the battery for the S Patch Ex then try to power on again by pressing and holding the power button for 3 seconds When I press the power button to turn on the power the LED light shows the red color Please reset the ECG patch following instructions below and try again if the connection fails 3 times the device will power off 1 First power off the S Patch device by pressing and holding the...
Page 20: ...ery CR2032 Battery Life 100 Hour replaceable Hardware Software CPU S1SBP6A Cortex M4F microprocessor BLE Nordic nRF52833 ARM Cortex M4 IMU ICM 42605 Memory W25 256MB OS Android iOS 8 and above 12 and above Physical Characteristics Weight Exc Battery 9g Dimension Power Unit Battery Unit 30mm x 6mm 30mm x 6mm Diameter x Height Dimension Cable 110 5 mm Technical Characteristics Heart Rate Range 30 24...
Page 21: ...installation If this equipment does cause harmful interference or television reception which can be determined by turning the equipment off and on the user is encouraged to try to correct the interference by one or more of the following measures Reorient or relocate the receiving antenna Increase the separation between the equipment and receiver Consult the dealer or an experienced radio TV techni...
Page 22: ...energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF Emissions CISPR 11 Class B The S Patch Ex is suitable for use in all establishments including domestic establishments and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purpose...
Page 23: ...t 30 Radiated RF IEC 61000 4 3 10 V m 80 MHz 2 7 GHz 80 AM at 1 kHz 10 V m 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 Recommended separation distance where P is the maximum output power rating of the transm...
Page 24: ...ld 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 If the measured field strength in the location in w...
Page 25: ...on distance according to frequency of transmitter m 150kHz to 80MHz 80MHz to 800MHz 800MHz to 2 5GHz V1 3Vrms E1 10V m E1 10V m 0 01 N A 0 04 0 07 0 1 N A 0 11 0 22 1 N A 0 35 0 7 10 N A 1 11 2 21 100 N A 3 5 7 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 tr...
Page 26: ...ation between the components in terms of the overall device architecture is described in the figure below 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 The ECG data will be transfer to the BLE processor based on UART protocol then i...
Page 27: ...27 ...
Page 28: ...de 1 and level 4 for secure pairing of mobile applications and the S Patch Ex device Use just works BLE secure pairing with strong key pairing and with ECDSA authentication SC003 Dynamic MAC address To prevent tracking of device by changing the MAC address dynamically SC004 Complex credentials PIN Use complex credentials PIN to avoid MITM attack between the mobile applications and the S Patch Ex d...
Page 29: ...ure pairing attempts SC022 Sequence number packet Packet should have sequence number to avoid replay attack SC023 Dual bank update Support dual bank update so that firmware can recovery to previous version if error occurs during updating SC024 Version checking Enable version checking so that only accept firmware with the same or higher version SC025 Hiding firmware version Do not expose firmware v...
Page 30: ...no longer supported The below points were considered when decommissioning the S Patch Ex device Notifying customers the end of life or end of support date as soon as possible with the reason so that customers can take any necessary action including removal of network connectivity transition to a supported product and implementation of compensating controls Customer data and information stored in S...
Page 31: ...c e g photo radiograph test results or physiologic data with identifying characteristics No B 4 Open unstructured text entered by device user operator No B 5 Biometric data No B 6 Personal financial information No C Maintaining private data Can the device C 1 Maintain private data temporarily in volatile memory i e until cleared by power off or reset Yes 2 C 2 Store private data persistently on lo...
Page 32: ...rk connection No 2 2 5 1 Remote service activity No 2 2 6 Other events describe in the notes section No 2 3 Indicate what information is used to identify individual events recorded in the audit log 2 3 1 User ID No 2 3 2 Date time No AUDT notes 3 AUTHORIZATION AUTH The ability of the device to determine the authorization of users 3 1 Can the device prevent access to unauthorized users through user...
Page 33: ...1 IGAU notes 1 AES CCM SHA256 authenticated encryption algorithm is applied Refer to Section 2 3 2 of HIMSS NEMA HN 1 2013 standard for the proper interpretation of information requested in this form Yes No N A or See Note Note 10 MALWARE DETECTION PROTECTION MLDP The ability of the device to effectively prevent detect and remove malicious software malware 10 1 Does the device support the use of a...
Page 34: ...separately purchased and or delivered operating system s including version number s No 14 2 Is a list of other third party applications provided by the manufacturer available Yes 1 RDMP notes 1 Soft device S113_7 0 2 nRF5 SDK 17 0 2 and nRF connect 2 0 3 15 SYSTEM AND APPLICATION HARDENING SAHD The device s resistance to cyber attacks and malware 15 1 Does the device employ any hardening measures ...
Page 35: ... 17 1 Can the device encrypt data at rest Yes 1 STCF notes 1 Encrypted ECG data will be stored in external memory when device is at rest 18 TRANSMISSION CONFIDENTIALITY TXCF The ability of the device to ensure the confidentiality of transmitted private data 18 1 Can private data be transmitted only via a point to point dedicated cable No 18 2 Is private data encrypted prior to transmission via a n...
Page 36: ...fies the object 3 Date of manufacture 4 Manufacturer 5 Prohibition 6 Warning 7 Caution 8 Instruction for User Manual 9 CF applied part 10 Prescription only 11 WEEE Mark 12 Keep Dry 13 Temperature limit 14 Humidity limitation 15 Non ionizing radiation 16 MR unsafe 17 Medical Device 18 Bluetooth symbol 19 FCC Symbol ...
Page 37: ...ce with the manufacturer s instructions This warranty will not apply If damage or malfunction results from negligence or improper use including but not limited to improper storage improper usage water submersion that does not meet the instructions of the manufacturer or physical abuse such as dropping or otherwise If damage or malfunction results from changes or modifications made to the S Patch E...
Page 38: ...sed out wheeled bin symbol indicates that waste electrical and electronic products WEEE should be disposed of separately from the municipal waste stream Wellysis Corp 8F 425 Teheran ro Gangnam gu Seoul Republic of Korea Tel 82 1800 2830 ...
Page 39: ...39 Appendix I Acronyms Acronym Full Text ECG Electrocardiograph HR Heart Rate HRV Heart Rate Variability ...
