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Samsung Confidential

[1]

USER MANUAL

Wearable Health Recording System

(MODEL: S-PATCH)

Caution: Federal law restricts this device to sale by or on the order of a physician.

Document No.: S-UM-01 (Rev. 0.3)

Samsung Electronics Co., Ltd.

1-1, Samsungjeonja-ro, Hwaseong-si, Gyeonggi-do, South Korea

Содержание S-PATCH

Страница 1: ...rable Health Recording System MODEL S PATCH Caution Federal law restricts this device to sale by or on the order of a physician Document No S UM 01 Rev 0 3 Samsung Electronics Co Ltd 1 1 Samsungjeonja ro Hwaseong si Gyeonggi do South Korea ...

Страница 2: ...020 01 20 Established by Manufacturer s User Manual Policy Rev 0 1 2020 01 28 Section 5 6 Updated specification of external device connection Rev 0 2 2020 02 07 Section 4 2 Deleted applied part description Section 5 3 Updated BLE specification Rev 0 3 2020 02 14 Section 8 Added FCC SDoC information ...

Страница 3: ... 15 5 1 How to Use S PATCH 15 5 1 1 Attachment to the patient body and Power On 15 5 1 2 Connection to the Mobile app 16 5 1 3 Completion of recording 19 5 1 Daily Usage 19 5 2 Data download and management 19 5 2 1 ECG Data Download and Display 19 5 2 2 ECG Data Import and Export 20 5 3 Specifications 21 5 4 Error Message 22 5 4 1 Device Disconnection 22 5 4 2 Abnormal Signal Detect 22 5 4 3 Low B...

Страница 4: ...Electromagnetic Immunity 28 7 4 Recommended separation distances between portable and mobile RF communications equipment and the S PATCH 29 7 5 Immunity and Compliance Level 29 8 FCC Compliance Statement 30 9 Expected Service Life time and Warranty 31 9 1 Expected Service Life Time 31 9 2 Product Warranty 31 10 Company Name and Address 31 ...

Страница 5: ...phone Product Name Wearable Health Recording System Model Name S PATCH Manufacturer SAMSUNG ELECTRONICS Co Ltd 1 1 Samsungjeonja ro Hwaseong si Gyeonggi do 18448 Korea 1 2 Indications for Use Intended Use The S PATCH Wearable health recording system is indicated for use on adult patients prescribed by physicians as an ECG data recorder for cardiac rhythm interpretation The S PATCH Wearable health ...

Страница 6: ... storage memory or the coin cell battery drains the Sensor device will not continue to collect your data 2 2 Safety 1 Before use the doctor must explain cautions to the patient 2 Operate the product in the correct order as described in this manual 3 Use this device under doctor s prescription 4 Beware of the polarity of the Coin battery when exchange and insert the battery and the battery certifie...

Страница 7: ...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 3 Warning MR unsafe Do not expose the device to a magnetic resonance MR environment 1 The device may present a risk of projectile injury due to the presence of ferromagnetic materials that can be attracted by the MR magnet core 2 Thermal injury and burns may occur due t...

Страница 8: ...hole Holes for ECG electrodes connecting Product code Product Serial Number QR code Cradle connection pins 10 pins for connecting to Cradle 4 1 2 Cradle Label Name Description Module connection pins 10 pogo pins for connecting to S Patch module Push button Locking door open button Locking door Locking door to fasten S Patch module to the Cradle USB cable Micro type B USB Cable LED LED Lamp to indi...

Страница 9: ...ic Interference problem 4 1 3 PC software 1 Login display 2 Main display Label Name Description Menu File Device View About File Information Recording Start Time DD MM YYYY hh mm Duration hh mm ss Serial number 8byte Sampling Frequency 256Hz Symptom Marking Input abnormal symptom time recorded by the ...

Страница 10: ... app Device connection on Device connected Label Name Description QR code scanning QR code scanning to connect Bluetooth Recording Time Recording time among the total recordable time Battery Remaining battery level Memory Storage memory usage level Lead on off Indication of module attachment on the patient body Setting Device disconnection Alarm per each display item 4 2 Accessory Components ...

Страница 11: ...Coin Battery Note Use the certified battery by IEC 60086 4 or UL1642 4 3 How to Start S PATCH 4 3 1 Required Environment o Windows 10 installed PC 200MB free disk space or greater Minimum High Speed USB 2 0 o PC software Installation file USB flash drive o Sensor device o Cradle and USB cable 4 3 2 System Initialization 1 PC software installation o Install setup file S Patch PC software setup exe ...

Страница 12: ...g the Sensor device into the Cradle o Open the sliding door on the bottom of the Sensing module to connect the Cradle o Attach the Sensing module to the Cradle Then the LED of the Cradle will turn green color 4 Execute S PATCH management S PATCH exe in the Desktop or PC software installed folder 5 Create User account ...

Страница 13: ...e lower case letter and at least one special case characters 6 Login with new ID Password 7 Click Device Connect in the Menu 8 Device Initialize will be activated in the Menu and Click Initialize o Enter Serial number printed in Packing box or Sensor device s bottom side o Setup the maximum recording time default time is 72 hours o Setup the Start time default time is set by current time in user P...

Страница 14: ... and insert the battery Lastly close the case and lock the screw 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 The battery certified to IEC 60086 4 or UL1642 should be used 2 Connect Electrodes to electrode connect hole in each side of ...

Страница 15: ...te 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 that it is recycled in a manner that protects human health and the environment For more information about where you can drop off your w...

Страница 16: ...hold the power button until LED is Off 5 1 2 Connection to the Mobile app 1 Copy the Mobile app S PATCH mobile app apk from the USB flash drive to the patient s smart phone 2 Install the Mobile app S PATCH mobile app apk on the smart phone Sensing module Battery module ...

Страница 17: ...3 Execute the Mobile app 4 QR code scanning on the packing box for Bluetooth paring If lose the box refer to the QR code in the Sensor device bottom side 5 After completing paring S Patch Device Monitoring display will appear ...

Страница 18: ...ding Time Battery Memory Lead states will be monitoring in Home screen If the connection is interrupted due to an abnormal condition Mobile app will display S Patch is disconnected and S Patch is not working S PATCH Mobile app uses BLE and storage of the host device And BLE needs Location ...

Страница 19: ...craft Undergoing an MRI 1 To finish the Mobile app press BACK button on the Android device or touch Multi tasking button on the Android device and close the app 2 Remove the Sensor device from the chest 3 When you are ready to put the Sensor device back on attach the Sensor device on the recommended position Turn on the Mobile app and resume monitoring the Sensor device status 5 2 Data download an...

Страница 20: ...imit area X axis 1sec Y axis 2mV Zoom out limit area X axis Full recorded time Y axis 100mV Cursor Create Cursor Menu View Cursor Cursor1 2 and difference will be displayed Marker Place the mouse pointer over the graph and right click Symptom Marking Add Create Marker entering Marker time name and time Created Markers will be displayed Symptom Marking window 5 2 2 ECG Data Import and Export 1 Expo...

Страница 21: ... Impedance 100 MΩ Power Requirements Power Supply 3Vd c Lithium coin battery Battery Life Up to 72 Hr Software F W version V1 00 CPU S1SBP6A Cortex M4F microprocessor BLE Dialog DA14583 ARM Cortex M0 App Android Android version 9 or later Physical Characteristics Weight Exc Battery 8g Dimension Battery module 2 29 5 5 mm 29 4 4 mm D H Dimension Connect Cable 110 10 mm Communication Bluetooth Max 1...

Страница 22: ...f the pop up After valid signal is detected it s changed to LEAD ON state 5 4 3 Low Battery Mode If the battery level is less than 10 you will get a notification that Battery is too low Figure 3 Press OK to turn off notifications When the battery runs out you will get a notification that Change the Battery Figure 4 Press OK to turn off notifications And then you need to change the battery 5 4 4 Lo...

Страница 23: ...ransmitted to the application from the device A The required specification of the interface and IT Network that combines PEMS 1 Sensor device Mobile App interface Data format Bluetooth Mobile Application Application on based Android Device status information Device information Bringing information when connecting to BLE Battery information Receiving information periodically B Technical specificati...

Страница 24: ...e IT Network update of equipment connected to the IT Network and upgrade of equipment connected to the IT Network 5 7 Heart Rate Algorithm The ECG signals converted to the digital values after the analog front end blocks The digital signals are filtered to reduce the noise such as electrical motion AC power noise 50 60 Hz and motion artifacts After enhancing the quality of the ECG signals the R pe...

Страница 25: ... Diameter x Height Serial Number Sensor device Dimension Connect cable 110 10 mm Serial Number Cradle Dimension Cradle 44 5 x 19 4 mm Diameter x Height Date of manufacture CAUTION Electric shock To avoid electrical shock do no disassemble the device Please read the user s manual carefully before use CF Type Prescription only Keep Dry Manufacturer Samsung Electronics Co Ltd 1 1 Samsungjeonja ro Hwa...

Страница 26: ... 2 Date of manufacture 3 Manufacturer 4 Caution Warning 5 Instruction for User Manual 6 Type CF applied part 7 Prescription only 8 WEEE Mark 9 Keep Dry 10 Non ionizing radiation 11 MR unsafe 6 2 Packaging Identification Components Quantity Main Box Sensor device 1 Electrodes 4 Battery 1 Quick guide 1 Sub Box Cradle 1 USB cable 1 USB flash drive 1 ...

Страница 27: ...lass B The S PATCH 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 S PATCH is intended for use in the electromagnetic environment specified below The customer or the user o...

Страница 28: ...ulated from the equation applicable to the frequency of the transmitter Recommended separation distance d 1 166 𝑝 150kHz to 80MHz d 1 166 𝑝 80MHz to 800MHz d 2 333 𝑝 800MHz to 2 5GHz where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in meters m Field strengths from fixed RF transmitters as...

Страница 29: ...e customer or the user of the S PATCH can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the S PATCH as recommended below according to the maximum output power of the communications equipment Rated maximum output power of transmitter W Separation distance according to frequency of transmitter m 15...

Страница 30: ...rference will not occur in a particular installation If this equipment does cause harmful interference to radio or television reception which can be determined by turning the equipment on and off the user is 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 receive...

Страница 31: ... S PATCH is guaranteed to last for a minimum of two years 9 2 Product Warranty The warranty covers a year However the conditions excluded by the warranty are as follows Natural aging of the product from daily usage Product damage due to improper storage Product damage due to improper usage 10 Company Name and Address Company name Samsung Electronics Co Ltd Address 1 1 Samsungjeonja ro Hwaseong si ...

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