Samsung SDS S-PATCH3-Cardio, User Manual

Page 1: ...th Monitoring System MODEL S PATCH3 Cardio Caution Federal law restricts this device to sale by or on the order of a physician Document No SDS UM 01 Rev 0 Samsung SDS Co Ltd 125 Olympic ro 35 gil Songpa gu Seoul Republic of Korea ...

Page 2: ... 2 Revision History Revision Number Issue Date Contents of revision Rev 0 0 2017 07 12 Established by Manufacturer s User Manual Policy ...

Page 3: ...nstallation of S PATCH3 CARDIO 8 3 1 Main Device Components 8 3 2 Accessory Components 9 3 3 How to Install S PATCH3 CARDIO 10 3 3 1 Installing S PATCH 10 3 4 Precautions 11 4 Using and Operating S PATCH3 CARDIO 12 4 1 How to Use S PATCH3 CARDIO 12 4 2 Specifications 17 4 2 1 S PATCH3 CARDIO Specifications 17 4 3 Error Message 18 4 4 Maintenance 18 4 5 Specification of External Device connection 1...

Page 4: ...ectromagnetic Immunity 22 6 3 Guidance and Manufacturer s Declaration Electromagnetic Immunity 23 6 4 Recommended separation distances between portable and mobile RF communications equipment and the EUT 24 6 5 Immunity and Compliance Level 25 6 6 Guidance and Manufacturer s Declaration Electromagnetic Immunity 26 7 FCC Compliance Statement 27 8 Expected Service Life time and Warranty 27 8 1 Expect...

Page 5: ...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 w...

Page 6: ...le around the neck 9 Conductive parts of electrodes and associated connectors for type CF applied parts should not contact other conductive parts including earth 2 3 Contra Indication 1 Patients with artificial cardiac pacemaker cardioverter defibrillator or other implantable electric devices 2 Pregnant or breast feeding mothers 3 A current sign or medical history of skin cancer rash skin disorder...

Page 7: ...0hPa 1060hPa 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 Cleaning Condition 1 Clean the device with soft dry cloth 2 Equipment failure may occur due to dust and debris during long term use of the equipment ...

Page 8: ...e 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 hole Holes for ECG electrodes connecting S PATCH3 CARDIO 6 6 5 4 2 1 3 S PATCH3 CARDIO ...

Page 9: ...ion 1 Electrode Multi purpose monitoring electrodes with sticky gel feature high performance adhesive and foam backing Note Use the FDA registered Electrode 2 Battery Power supply for S PATCH3 CARDIO DC 3V Coin Battery The Applied Parts are main device and electrode ...

Page 10: ... CARDIO First release the screw on main body1 using screw driver Second open the upper case of main body1 and insert the battery Lastly close the case and lock the screw Caution 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 Connect El...

Page 11: ... cloth 6 This product must not be disposed of with your other household waste Instead it is your responsibility to dispose of your waste equipment by handing it over to a designated collection point for the recycling of waste electrical and electronic equipment The separate collection and recycling of your waste equipment at the time of disposal will help to conserve natural resources and ensure t...

Page 12: ...O 1 After connect the electrodes with S PATCH3 CARDIO peel the plastic on the backside of the electrodes 2 Attach the S PATCH3 CARDIO on recommended position as drawn 3 Push the power button longer than 3 seconds 4 Confirm that the LED is ON and OFF 3 times S PATCH3 CARDIO ...

Page 13: ...ute S PATCH App 6 1 Open the App to see following sequence of screens 6 2 Press Connect S Patch button on lower center of screen 6 3 Wait while the app searches for device 6 4 Select device to connect 6 5 Press Connect after confirming test sequence test ID and patient name patient ID ...

Page 14: ...ical screen for full screen view of ECG 6 7 Press Add Symptom button to record any symptoms instantly This button will save a not specified symptom on diary tab to which user can add details at a later time After button is pressed Symptom has been saved message appears momentarily at bottom of screen ...

Page 15: ... 15 6 8 Press New Diary to create a new diary entry 6 9 Enter start date and time of symptom 6 10 Enter end date and time of symptom 6 11 Press Select Symptom and select a symptom from list ...

Page 16: ...upload to cloud but in case user desires to end the test early press the menu button on upper left of screen 6 15 Press End Test on the bottom of menu options 6 16 An End test message will appear and user can press End to end the test 6 17 When manually ending the test the test data also requires manual sending After the test is ended screen will change to send data screen ...

Page 17: ...ngle channel Circuitry Communication with Mobile device Bluetooth DC Offset Tolerance 300mV ADC Resolution 12 bits ADC Sampling Rate 1000 Samples Second Input Impedance 100 MΩ Power Requirements Power Supply 3 Vd c Lithium coin battery Battery Life 120 Hr Software F W version V1 00 CPU S1SBP6A Cortex M4F microprocessor BLE Dialog DA14583 ARM Cortex M0 App Android Kitkat API19 or later Physical Cha...

Page 18: ...evice status information Device information Bringing information when connecting to BLE Battery information Receiving information periodically Data to Device Data Channel Transmits the data to the device B Technical specification about network connection of PEMS including security features 1 Mobile Application is designed to not affect by an external virus infiltration But if infected with virus O...

Page 19: ... the excluded section is 1 second the V beat in the center will have HR value of 6 5 1 60 91 bpm 5 2 Average HR calculation of a section Average HR of a section is calculated with the beats included in the section If the above data is within a 20 second frame the average HR is calculated as follows Number of effective sections Total length of effective sections 60 At this time section refers to th...

Page 20: ... 20 6 Labels and Packaging 6 1 Labels 6 1 1 Label for Packaging 6 1 2 Label for module Front side 2 Labels Rear side 2 Labels ...

Page 21: ...tion for User Manual 6 Type of applied part 7 Prescription only 8 WEEE Mark 9 Keep Dry 6 2 Packaging 6 2 1 Package List Classifications Components Quantity Main Box S PATCH3 CARDIO module 1 Electrodes 4 Battery 1 Manual 1 6 2 2 Package Units 1 S PATCH3 CARDIO module Main module 2 Electrodes 4 Electrodes are in the 1 plastic bag 3 Battery 1 Coin Cell battery is shipped at package 4 Manual ...

Page 22: ...ATCH3 is suitable for use in ail establishments including domestic establishments and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes 7 2 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 ...

Page 23: ...ands between 0 15 MHz and 80 MHz 80 AM at 1 kHz 10 V m 80 MHz 2 7 GHz 80 AM at 1 kHz Portable and mobile RF communications equipment should be used no closer to any part of the S PATCH3 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 th...

Page 24: ...e is observed additional measures may be necessary such as re orienting or relocating the EUT b Over the frequency range 150kHz to 80MHz field strengths should be less than V1 V m 7 4 Recommended separation distances between portable and mobile RF communications equipment and the EUT There is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The cu...

Page 25: ... 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 Electromagnetic propagation is affected by absorption and reflection from structures objects and people 7 5 Immunity and Compliance Level Immunity test IEC 60601 Test Level Actual Immunity Level Compliance Lev...

Page 26: ... by an electromagnetic site survey should be less than 3V m a Interference may occur in the vicinity of equipment marked with the following symbol NOTE 1 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people NOTE 2 It is essential that the actual shielding effectiveness and filter attenuation of the ...

Page 27: ...orrect the interference by one or more of the following measures Reorient or relocate the receiving antennae Increase the separation between the equipment and the receiver Connect the equipment into an outlet on a circuit different from that to which the receiver is connected Consult the dealer or an experienced radio TV technician for help FCC RF Exposure Statement This equipment complies with FC...

Page 28: ... Company Name and Address Company name Samsung SDS Co Ltd Address 125 Olympic ro 35 gil Songpa gu Seoul Republic of Korea Tel 82 2 6155 3114 10 2 EC Representative Name Samsung SDS Europe Address KT13 0NY 1st Fl No 5 The Heights Brooklands Weybridge Surrey United Kingdom Contacts Phone 44 7825 035 687 Fax N A ...