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Samsung Confidential

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5.

Labels and Packaging

5.1

Labels

5.1.1

Label for Packaging

5.1.2

Label for module

Front- side 2 Labels

Rear-side 2 Labels

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Summary of Contents for S-Patch3

Page 1: ...Samsung Confidential 1 USER MANUAL Wearable Health Monitoring System MODEL S PATCH3 Document No S UM 01 Rev 0 2 Samsung Electronics Co Ltd 1 1 Samsungjeonja ro Hwaseong si Gyeonggi do South Korea ...

Page 2: ...istory Revision Number Issue Date Contents of revision Rev 0 0 2016 12 28 Established by Manufacturer s User Manual Policy Rev 0 1 2017 1 5 5 1 Label Update Rev 0 2 2017 2 9 5 1 Label Update Rev 0 2 2017 2 9 4 2 1 Spec Update 서식 있음 양쪽 ...

Page 3: ...7 2 4 2 Conditions for Storage 7 2 4 3 Cleaning Condition 7 3 Components and Installation of S PATCH3 8 3 1 Main Device Components 8 3 2 Accessory Components 9 3 3 Display viewer 10 3 4 How to Install S PATCH3 18 3 4 1 Installing S PATCH 18 3 5 Precautions 18 4 Using and Operating S PATCH3 20 4 1 How to Use S PATCH3 20 4 2 Specifications 25 4 2 1 S PATCH3 Specifications 25 4 3 Error Message and Al...

Page 4: ...tic Emissions 33 6 2 Guidance and Manufacturer s Declaration Electromagnetic Immunity 33 6 3 Guidance and Manufacturer s Declaration Electromagnetic Immunity 34 6 4 Recommended separation distances between portable and mobile RF communications equipment and the EUT 35 6 5 Immunity and Compliance Level 36 6 6 Guidance and Manufacturer s Declaration Electromagnetic Immunity 37 7 FCC Compliance State...

Page 5: ...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 without the manufacturer s guide is n...

Page 6: ...OT swallow the device or wind the cable around the neck 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 keloid and or any injury ...

Page 7: ...c pressure 700hPa 1060hPa 2 4 2 Conditions for Storage 1 Temperature 20 70 4 to 158 2 Relative humidity 10 95 non condensing 3 Atmospheric pressure 400hPa 1500hPa 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: ...onents S PATCH3 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 hole Holes for ECG electrodes connecting ...

Page 9: ... Name Description 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 DC 3V Coin Battery The Applied Parts are main device and electrode ...

Page 10: ...Samsung Confidential 10 3 3 Display viewer 1 Main Display of S PATCH3 App 서식 있음 글꼴 영어 바탕 한글 바탕 11 pt ...

Page 11: ...nal receiving time A 2 Device ID Connected S PATCH Device s ID A 3 BLE Connection Indicator Bluetooth Low Energy Connection State A 4 Device Battery Indicator Remained battery state of the connected device In the case of the ratio is lower than 25 Battery is too low Notification will appear ...

Page 12: ...respiratory rate is from 9 BrPM to 30 BrPM The resolution is 0 96 BrPM During measure the Respiratory Rate minimize move B 5 PAUSE Indicator PAUSE mode indicator Even in PAUSE mode received signal will be stored B 6 Left side Time The elapsed time of the left side signal B 7 Right side Time The elapsed time of the right side signal B 8 Magnification Ratio The magnification ratio of the ECG signal ...

Page 13: ...ground black signal D 5 Import from file read signal data from stored file S PATCH format sp and MIT BIH format hea dat 16 format only for exported by this app can be loaded If there is no folder stored signal files check your system options like below In case of Android OS Internal Storage would be hidden ...

Page 14: ...d sp S PATCH format This button makes MIT BIH format file The file name is automatically generated by based on the Device Number and the first connection time D 7 Show HRV View shows HRV information view D 8 Show Hide HR Trend View show hide HR Trend View HR Trend View shows HR trend and minimum maximum HR for 1 Hour ...

Page 15: ... RRI difference of successive RRIs greater than 50ms E 1 6 PNN50 NN50 as a percentage of all allowed RRIs E 1 7 RMSSD root mean square of successive differences in ms E 1 8 TINN triangular index interval is the baseline width of the distribution measured as a base of a triangle approximating the RRI distribution E 2 Frequency Domain HRV E 2 1 VLF very low frequency power 0 00333 Hz to 0 040 Hz E 2...

Page 16: ...number in bracket after S PATCH name is the Device ID RSSI is Received signal strength indication in a wireless environment in arbitrary units It could be used to calculate distance of the S PATCH and the host device F 2 Nothing available This will disconnect connected device and stay without any connection F 3 Cancel This will back without any changes F 4 App version This shows App s version ...

Page 17: ... Signal Viewer Swipe gesture will scroll the time range G 6 Small Time Range Navigation This supports specific time selection in small time range by touch If total time range is too small this will disappear G 7 Total Time Range Navigation This supports the selection of the Small Time Range Navigation s range on the total time range H Viewer Menu Button BACK button supports return of previous wind...

Page 18: ...CH3 3 5 Precautions 1 The electrodes and coin battery are disposable Please observe local laws for disposal of electrodes and coin battery 2 Please ensure user s hands are clean and dry when handle the S PATCH3 3 The body hair possibly causes contact problem which results a fault detection of physiological data 4 After using the device wipe dust and other foreign substances using a dry cloth 5 Thi...

Page 19: ...elp to conserve natural resources and ensure that it is recycled in a manner that protects human health and the environment For more information about where you can drop off your waste equipment for recycling please contact your local city office your household waste disposal service or the shop where you purchased the product ...

Page 20: ...How to Use S PATCH3 1 After connect the electrodes with S PATCH3 peel the plastic on the backside of the electrodes 2 Attach the S PATCH3 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 ...

Page 21: ...bile device 6 Please execute S PATCH App 7 Please touch the Menu Button located right bottom side like as below 8 Menu Buttons will appear then touch DEVICE button Buttons will disappear if there is no selection for 3 seconds 9 Connectable S PATCH Devices will be added to the list ...

Page 22: ...d storage of the host device And BLE needs Location Permission so BLE Location and Storage permissions are requested If it s denied one of them the app could not receive and store signal data 10 Select the device to be connected 11 After pairing S PATCH device top right side s connection indicator will be updated and ECG Signals will be shown as following as BLE transmission ...

Page 23: ...nerated by S PATCH device number and connection time Above example means S PATCH 3105 device s signals are received since 2015 year January 1st day PM 1 30 47 Same name s folder has detail data Algorithm Result Heart rate Respiratory Rate and Heart rate variability will be updated after valid signals are received for required time range for each algorithm ...

Page 24: ...IMPORT button through Menu Button and choose the file Then it will be loaded like below Bottom navigation and swiping on signal graphs are able to move on the showing time And HR RR and HRV values are updated as following as the time If the S PATCH device is connected received signal will be stored in background ...

Page 25: ...ns Classification Name Description Performance Type CF Type Channel Single 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 DC 3V Coin Battery CR2032 Battery Life 48 Hr Software F W version V1 00 CPU S1SBP6A Cortex M4F microprocessor BLE Dialog D...

Page 26: ...cted on receiving signal BLE connection indicator is updated And notification will appear with alarm or vibration as user s setting Mute setting woulddoes not make any alarm sound and vibration 4 3 2 Abnormal signal detect In case of algorithm detects invalid signal assume LEAD OFF state and show below ...

Page 27: ...low All algorithms are not available After valid signal is detected it s changed to LEAD ON state and algorithms are restarted 4 3 3 Low Battery mode Battery state is updated on top right of the STATUS bar Battery Icon s meaning is like below ...

Page 28: ... too low Notification will appear In the case of the ratio is lower than 10 Change Device s Battery Notification will appear 4 3 4 Low Remaining Storage If the remaining storage is under 10MB caution will appear Then make some more remaining storage If not signal would be lost ...

Page 29: ...ft dry cloth after using the S PATCH 3 Please attempt to keep S PATCH3 dust free S PATCH is waterproof But it should be kept dry This device does not have serviceable components Do not disassemble crush puncture short external contacts or circuits dispose of in fire or water ...

Page 30: ...Samsung Confidential 30 5 Labels and Packaging 5 1 Labels 5 1 1 Label for Packaging 5 1 2 Label for module Front side 2 Labels Rear side 2 Labels ...

Page 31: ...that identifies the object 2 Date of manufacture 3 Manufacturer 4 Caution Warning 5 Instruction for User Manual 6 Type of applied part 7 Prescription only 8 WEEE Mark 9 Temperature limitation 5 2 Packaging 5 2 1 Package List Classifications Components Quantity Main Box S PATCH3 module 1 Electrodes 4 Battery 1 Manual 1 ...

Page 32: ...Samsung Confidential 32 5 2 2 Package Units 1 S PATCH3 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 33: ... A Voltage fluctuations Flicker emissions IEC 61000 3 3 Complies 6 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 assure that it is used in such an environment Immunity test IEC 60601 Test level Compliance level Electromagnetic environment Guidance Electrost...

Page 34: ...equency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment NOTE Uт is the A C Mains voltage prior to application of the test level 6 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 t...

Page 35: ...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 which the EUT is used exceeds the applicable RF compliance level above the EUT should be observed to verify normal operation If abnormal performance is observed additional measure...

Page 36: ...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 Electromagnetic propagation is affected by absorption and reflection from...

Page 37: ...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 shielded location be verified to assure that they meet the minimum specificatio...

Page 38: ...encouraged to try to correct 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 equi...

Page 39: ...per storage Product damage due to improper usage 9 Company Introduction 9 1 Company Name and Address Company name Samsung Electronics Co Ltd Address 1 1 Samsungjeonja ro Hwaseong si Gyeonggi do 18448 Korea Tel 82 31 8037 3533 e mail s patch samsung com ...

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