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Senso BioPot3 Instructions For Use Manual

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BioPot3 Device
Instructions For Use
Sensomedical Labs
LTD
Manufacturer:
Sensomedical Labs LTD.
Nazareth Industrial Park, Mount Precipice
Nazareth 1612102, Israel
+972 (0)4 6800668

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Summary of Contents for Senso BioPot3

  • Page 1 BioPot3 Device Instructions For Use Sensomedical Labs Manufacturer: Sensomedical Labs LTD. Nazareth Industrial Park, Mount Precipice Nazareth 1612102, Israel +972 (0)4 6800668...

  • Page 2: Table Of Contents

    Contents 1. BIOPOT3 Kit .............................5 1.1 BIOPOT VERSIONS, PRODUCT FAMILY DESCRIPTION ............5 1.2 KIT ...............................5 1.3 BIOPOT: ..............................6 1.3 Charging .............................. 6 1.4 Powering ..............................7 1.5 Reference and ground switch ......................7 1.6 BIOPOT CAP ............................8 1.7 BIOPOT Name Description .........................8 1.8 BIOPOT LEDs mode ...........................9...
  • Page 3 4. Requirements ............................42 5.1. Temperature and Humidity: ......................42 5.2. The BIOPOT3 V2 shall withstand during operation the following conditions: Temp: 0°C – 40°C and Humidity: 20 -90 % .......................... 42 5.3. The BIOPOT3 V2 shall withstand during storage the following conditions: Temp: -10°C – 50°C and Humidity: 20 -90 % ..........................
  • Page 4 6.11. Technical Description: ........................45 7. General information ..........................45 7.1. Manufacturer: Senso Medical LTD ....................45 7.2. Costumer: Senso Medical Labs Ltd....................45 7.3. Costumer's Address: ......................... 45 7.4. Equipment Model No.: BP-30-08-00061 ..................45 7.5. Equipment Serial No.: 61 ......................... 45 7.6.

  • Page 5: Biopot3 Kit

    1. BIOPOT3 Kit 1.1 BIOPOT VERSIONS, PRODUCT FAMILY DESCRIPTION 1.2 KIT KIT includes BIOPOT3 device, docking charging station, and USB-C charging cable:...

  • Page 6: Biopot

    1.3 BIOPOT: 1.3 Charging You need to enter the docking station as picture bellow connected to USB cable: When power cable is connected the yellow LED should turn on and docking station green LED...

  • Page 7: Powering

    1.4 Powering  Short press on power button turns BIOPOT ON, BIOPOT green LED should start blinking.  Long press on power button turns BIOPOT OFF (close to 1.5 seconds). 1.5 Reference and ground switch  If switch to the right side that means reference and ground are shorted. ...

  • Page 8: Biopot Cap

    1.6 BIOPOT CAP 1.7 BIOPOT Name Description Index Description Values “SML BIO” [8 chars] Unchangeable 10-11 Channels number [2 chars] 08/16/19 X- without accelerometer Accelerometer [1 char] A-with accelerometer X- without bioimpedance Bio-impedance [1 char] I-with bioimpedance Serial number. 14-19 Serial number [4 chars] Value from 0 to 65535 Example: SML BIO 08AX00005: This means, that the EEG device is having 8channels with...

  • Page 9: Biopot Leds Mode

    In order to install android application, follow these steps:  Download APK file that you get from SensoMedical Labs.  If you already have BIOPOT3 application on your device, you need to uninstall it.  Move APK file to your phone or tablet.
  • Page 10  Location APK file and press on it press “install” and follow installation process till installation done.  After installation done, BIOPOT3 application should appear on your home screen:...

  • Page 11: Launch Application & Set Permissions

    2.3 Launch application & set permissions Press on BIOPOT3 icon to open application, on first application launch you need to allow android permission in order:...

  • Page 12: Patient, Session & User Details

    NOTE: make sure that location is Enabled on your android device. 2.4 Patient, Session & user details Note: this part can be skipped, press “Skip all” and default parameters will be set ( as shown below). This is Patient Details screen:...
  • Page 13 you can Scan patient barcode or enter patient code: Note: Next button will be disabled if patient code not filled.
  • Page 14 Press “Next” to set Session details:...
  • Page 15 Here you can set BIOPOT recording file location and files name. Based on example above, recording application files will be on: phone internal storage >> Biopot data files. Files name start with BioPot followed by time, date and number of file same as shown in Example.
  • Page 16 Here you can set user details: Name, ID, Role and Email. This information will be shown on recording files. NOTE: this information will be saved on recording text files only. Press “Done” to “Connect to BIOPOT”.

  • Page 17: Connect To Biopot

    2.5 Connect to BIOPOT Application locating BIOPOT devices: If application couldn’t find BIOPOT devices, you shall see this screen:...
  • Page 18 You need to press “Try again” to start location BIOPOT devices again, till you find your BIOPOT device:...

  • Page 19: Main Screen

    If you have more than one device, select the BIOPOT needed to connect and press “Start” Button. 2.6 Main screen If application succeeds to connect to BIOPOT you should see channels main screen:...

  • Page 20: Biopot Information

    Main screen divided to several sections: 2.6.1. BIOPOT information: BIOPOT information located on the top left on main screen: Here you can find the BIOPOT name, EEG/EMG channels number, accelerometer status and Bio-impedance status. If you press on icon, application navigate to connection screen. 2.6.2.
  • Page 21 Omega icon navigate to impedance measurement screen. Flash icon navigates to samples per second’s graph: Folder icon navigates to saved recording files. Setting icon navigate to:...

  • Page 22: Eeg/Emg Channels

    Here you can set the number of channels you need to see on main screen on each channels types: EEG/EMG, Bio-impedance or Accelerometer. Additional setting label navigates to additional setting screen. This label navigate to Patient, Session & user details screen that set before. 2.6.3.

  • Page 23: Accelerometer Channels

    Using , you can change charts period value. Pressing will reset amplitude to default value 300 micro volt / 10 seconds. 2.6.4. Accelerometer channels On Accelerometer section you should see BIOPOT accelerometer X, Y, and Z accelerometer axis’s if the accelerometer enabled in BIOPOT device. 2.6.5.
  • Page 24 You can switch between channels using “Next” and “Prev” buttons and channels types: All channels referenced to same referrance/ground, in order to montage channels you need to change referance to wanted channel on the buttom of the zoom channel screen: After choosing wanted montage channel press “Apply”...
  • Page 25 When choosing “montage channel”, channel label will change based to chosen montage channel: From that’s mean that 5 is montaged by channel 1.

  • Page 26: Impedance Measurement

    2.8 Impedance measurement From main screen, omega icon navigate to impedance screen: Based on impedance colors and “impedance” you can tell the impedance value/interval. Based on “channels mapping” you can recognize channel number of impedance measurement. 2.9 Additional settings, filters and device readout To enter “Additional setting”...
  • Page 27 Here you can set/change the BIOPOT parameters. Hardware low pass filter, hardware high pass filter and sampling rate parameters for A2D chip. Software low pass filter – this filter process after the A2D HW LPF and HPF. Notch filter – this filter process for removing noise on application channel and not applied on recording data.

  • Page 28: Recording Data

    Here you can see BIOPOT battery percentage and BIOPOT temperature 2.10 Recording data To start recording data, press on from main screen, recording button should change and timer for recording period should appears next to it If you need to stop recording, press on button.
  • Page 29 Extract saved recording files from android device based on “session details” (by default, files saved on: internal Storage >Biopot data files) to:...

  • Page 30: Recording Data Types

    2.10.1. Recording data types 2.10.1.1. EDF/BDF files Based on BIOPOT version, data recording files type changes, BIOPOTs 16bits in EDF and BIOPOTs 24bits in BDF format. EDF and BDF files can be opened on any EEDF and BDF readers like EEEGLAB and BDF 2.10.1.2.
  • Page 31 12[acc] 4 [TS] + 19*6*2 4 [TS] + Activated 19*6*2+ 12[acc] 4 [TS] + Activated 15*7*2+ Activated on 4 12[acc]+ channels 4[bio] 4 [TS] + 8*10*3 4 [TS] + 8*9*3+ Activated 12[acc] Example of type 5 from table above: Start index Low/high index...
  • Page 32 high Point 2 high high Example of type 7 from table above: Timestamps high high high high high Sample 1 of 19 channels high high … CH19 high Sample 2 of 19 channels Sample 3 of 19 channels Sample 4 of 19channels same …...
  • Page 33 high Example of type 11 from table above: Start index Low/high index index Timestamps high high high high high Sample 1 of 9 channels high high high high Sample 2 of 9 channels …. Same … … … Sample 9 of 9 channels high Point 1 high...
  • Page 34 Data start with 4 bytes of timestamps followed by A2d data sample by sample for all channels based on number of samples followed by accelerometer data if accelerometer is enable. NOTES: all data saved in little endian format (low to high). ...

  • Page 35: Connection To Biopot Was Lost

    2.12.1. Connection to BIOPOT was lost...

  • Page 36: Ble Protocol

    This message appears when BIOPOT disconnected, application stuck in “locating connection” screen in order to locate same BIOPOT and automatically connect it. In order to exit this screen, press the back button on the left/right bottom device bar. BLE Protocol BLE data protocol: 4.1 Characteristics 1 - [Read &...
  • Page 37 BIOPOT data size Else -16 bits 1 – Sync Enabled (in the test device when this byte is Sync Enable written as 1 a sync simulation will Not implemented start after 3 seconds) 0 – Sync disabled Serial number BIOPOT3 serial number...

  • Page 38: Characteristics 2 - [Read & Write]

    4.2 Characteristics 2 - [Read & Write] Index 0 – Turn data acquisition off 1 - Turn data acquisition on BIOPOT data acquisition 2- Read external Memory 3- Erase External Memory 4.3 Characteristics 3 - [Read & Write] Index 0.off 1.On Impedance measurement 2.Offset Calibration...

  • Page 39: Characteristics 4 [Notify]

    4.4 Characteristics 4 [Notify] There 7 types of characteristics 4 buffer data, which depends on the number of channels, number of samples per channels, accelerometer and bio impedance, explained in the table below: Data Samples Buffer Buffer Channel Bio- Type BioPot size Accelerometer bytes...

  • Page 40: Characteristics 5 [Read & Write]

    4.5 Characteristics 5 [Read & Write] Index Bit [32,31, 30…...25] 16bits: Bit [24,23, 22…...17] Channels off/on. 24bits Bit [16,15, 14…...9] Not used Bit [8,7,6,5, 4...…1] Not used Index. Cutoff [Hz] Index. Cutoff [Hz] No HPF 0.25 24bits: SW High pass filter sampling rate 500[default]/1000/2000 Not used...
  • Page 41 4.6 Characteristics 6 [Notify] Reserved Reserved Reserved Reserved Reserved Reserved Read Percentage 0-100 Read Finished Sector Number being erased 0-2048 Read Page Number 0-32768 Write Page Number 0-32768 Reserved Reserved Battery level value 0-100 Temperature value Current Device temperature 0. Battery is charging Battery charging 1.
  • Page 42 Requirements 5.1. Temperature and Humidity: 5.2. The BIOPOT3 V2 shall withstand during operation the following conditions: Temp: 0°C – 40°C and Humidity: 20 -90 % 5.3. The BIOPOT3 V2 shall withstand during storage the following conditions: Temp: -10°C – 50°C and Humidity: 20 -90 % 5.4.
  • Page 43 6. Instructions for use 6.1. The device may be used by a researcher/professional in a specialized lab for data acquisition. It can also be used by a home user together with a mobile device or PC for data acquisition. 6.2. The device is used by a researcher/professional in a specialized clinical lab for data acquisition.
  • Page 44 6.9.2. Use by unskilled/untrained personnel may lead to wrong usage and wrong results that may pose a risk to the patient’s life or Harm to the device. 6.9.3. Inadequate warning of hazards likely with re-use of single use medical devices. Like the electrode sticker.

  • Page 45: General Information

    6.11.4. All necessary instructions for maintaining basic safety and essential performance with regard to electromagnetic disturbances for the expected service life. 7. General information 7.1. Manufacturer: Senso Medical LTD 7.2. Costumer: Senso Medical Labs Ltd. 7.3. Costumer's Address: P.O. Box: 2653 Industrial Park Building, Mount St.\ Industrial Zone...

  • Page 46: Immunity Test

    9. Declaration – electromagnetic emissions Declaration – electromagnetic emissions Emissions test Compliance Electromagnetic environment – guidance RF emissions CISPR 11 Group1 Class A The BioPot SYSTEM uses RF 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.
  • Page 47 0° 0% UT; 250/300 cycle Power frequency 30 (A/m) 30 (A/m) Power frequency magnetic fields (50/60 Hz) should be at levels characteristic of a magnetic field typical location in a typical IEC 61000-4-8 commercial or hospital environment. NOTE UT is the a.c. mains voltage prior to application of the test level.
  • Page 48 11.Recommended separation distances between portable and mobile RF communications equipment and the BioPot SYSTEM Recommended separation distances between BioPot SYSTEM portable and mobile RF communications equipment and the Rated maximum Separation distance according to frequency of transmitter output power of transmitter 150 kHz to 80 MHz 150 kHz to 80 MHz 80 MHz to 800 MHz...

  • Page 49: Fcc Warning

    1720 1 700 GSM 1800; Pulse – CDMA 1900; modulati 1 990 GSM 1900; 1845 DECT; 217 Hz LTE Band 1, 1970 4, 25; UMTS 2450 2 400 Bluetooth, Pulse – WLAN, modulati 2 570 802.11 b/g/n, RFID 2450, 217 Hz LTE Band 7 5240 5 100...

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