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MC10 BioStamp nPoint Instructions For Use Manual

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Summary of Contents for MC10 BioStamp nPoint

  • Page 1 Instructions for Use...
  • Page 2 BioStamp nPoint User Manual...
  • Page 3 BioStamp nPoint User Manual Only...

  • Page 4: Table Of Contents

    Precautions....................9 Storage and Handling................9 Device and Packaging Symbols and Markings......10 Regulatory Information..................13 Applicable Standards................13 FCC Compliance Notification............13 BioStamp nPoint Platform Components............14 BioStamp nPoint Component Assembly and Function Overview..15 Link Hub....................15 Tablet......................16 Sync Phone....................16 Link Phone....................17 BioStamp Sensors.................18 Adhesives....................20 Maintenance......................24...
  • Page 5 BioStamp nPoint User Manual Link Hub and BioStamp Sensor Frequency and Transmission Specifications..............48 Hardware LED Status Indicator Table..........48 EMC Declaration and Guidance................49 Guidance and Manufacturer’s Declaration – Electromagnetic Emissions...............49 Guidance and Manufacturer’s Declaration – Electromagnetic Immunity...............50 Appendix B..........................53 Portable Emissions Measurement System (PEMS) connection to an IT-Network........................54...

  • Page 6: Introduction, Safety, And Component Overview

    Introduction, Safety, and Component Overview...

  • Page 7: System Description

    Investigator Portal. For laboratory or clinic (“Supervised”) settings, BioStamp nPoint includes a Tablet Investigator Application (“Investigator App”) to be used for the set-up and configuration of the sensors. When BioStamp nPoint is used in the home or outside of the clinic (“Remote”) setting, study subjects interact with the system through a Mobile Phone Application called the “Link App.

  • Page 8: Important Safety Information

    The device is intended for use on general care patients who are 18 years of age or older as a general patient monitor to provide physiological information. The data from the BioStamp nPoint system is intended for use by researchers and healthcare professionals for research applications or, at the discretion of a qualified healthcare professional, as an aid to diagnosis and treatment.

  • Page 9: Precautions

    Return all components of the BioStamp nPoint system to your health care provider and/or study staff at the conclusion of your prescribed period of use. • Dispose of the BioStamp nPoint system per local laws, care facility laws or hospital laws for routine/non-hazardous electronic waster. Storage and Handling •...

  • Page 10: Device And Packaging Symbols And Markings

    BioStamp nPoint User Manual Device and Packaging Symbols and Markings Meaning Symbol Description To identify the location where the operator’s manual is stored or to identify information that relates to the operating instructions. To indicate Instructions for Use that the operating instructions should...
  • Page 11 BioStamp nPoint User Manual Meaning Symbol Description To identify the manufacturer’s serial number, for example on a medical Serial Number device or its packaging. The serial number shall be placed adjacent to the symbol. Choking Warning Keep out of reach of children; choking Symbol hazard for children ages 0-3 years.
  • Page 12 BioStamp nPoint User Manual Meaning Symbol Description To identify the minimum temperature Lower Temperature limit. The temperature value may be Limitation shown adjacent to the symbol. To indicate on the rating plate that the equipment is suitable for direct Direct Current current only;...

  • Page 13: Regulatory Information

    Usability Engineering for Medical Devices FCC Compliance Notification The BioStamp nPoint System was verified for RF exposure and found to com- ply with Council Recommendation 1999/519/EC and FCC OET-65 RF exposure requirements. This equipment complies with FCC radiation exposure limits set forth for an uncontrolled environment.

  • Page 14: Biostamp Npoint Platform Components

    Supervised Components Mobile Phone with Sync Application Remote Components Mobile Phone with Link Application Remote components of BioStamp nPoint are intended for Note operational use by the patient. Supervised components of BioStamp nPoint are intended for operational use by investigators.

  • Page 15: Biostamp Npoint Component Assembly And Function Overview

    BioStamp nPoint User Manual BioStamp nPoint Component Assembly and Function Overview Ensure system components are fully charged before each use. Note Link Hub BioStamp nPoint includes a charging platform, called the Link Hub that holds and charges the Link Phone (for Remote Studies),...

  • Page 16: Tablet

    Investigator App. For full functionality, the tablet must be connected to a Wi-Fi network and have Bluetooth turned on. You can log in to the Investigator App using your BioStamp nPoint credentials and log out through the Investigator App settings. Turn off the tablet by holding down the power button and selecting the “power off”...

  • Page 17: Link Phone

    (Wi-Fi, mobile, etc) and have Bluetooth turned on. You must be an investigator to log in to the Sync App using your BioStamp nPoint cre- dentials. To sign out press the “sign out” button in the Sync App. Turn off the Sync Phone by holding down the power button and selecting the “power off”...

  • Page 18: Biostamp Sensors

    BioStamp nPoint User Manual BioStamp Sensors The BioStamp Sensor is an extremely thin, body-worn system designed to measure and record biometric signals. The Sensor is optimized for small size and low power operation. BioStamp Sensors can collect biopotential (surface electromyography) and accelerometry (limb and body movement) data.
  • Page 19 BioStamp nPoint User Manual Power Sensors On and Off To power Sensors on, simply place the Sensors in the sensor pockets on the Link Hub. BioStamp Sensors are shipped in a powered-off state. The LED light in the upper right corner of the Sensor will be solid blue when charging and solid green when ready.

  • Page 20: Adhesives

    24-hour wear duration. The Dorsal Foot and Dorsal Hand locations are particularly prone to adhesion issues due to the movement and body morphology of these specific areas. MC10 recommends providing an additional method of securing the Sensors to these body locations and for use during certain activities.
  • Page 21 BioStamp nPoint User Manual Place the adhesive applicator guide on a flat surface. Fit the Sensor, electrode side up, in the applicator sensor pocket. Remove the labeled sensor-side liner from the adhesive sticker. Align the two semi-circular cutouts on the bottom side...
  • Page 22 BioStamp nPoint User Manual Applying Sensors to Body During Remote Studies, the subject may refer to the Link App and the Subject Instructions for Use for Sensor application and removal instructions. Skin Preparation Proper skin preparation improves Sensor adhesion and signal quality.
  • Page 23 BioStamp nPoint User Manual Remove Sensor To remove a Sensor, simply grab the hold tab on the thicker end of the Sensor and peel the Sensor and adhe- sive off the skin. The Sensor and adhesive should peel off cleanly. Any adhesive residue on the skin can be removed with baby oil or alcohol-based solvents.

  • Page 24: Maintenance

    BioStamp nPoint User Manual Maintenance Upgrading System Components In the event that an upgrade is needed for any component of BioStamp nPoint (BioStamp Sensor, Link Hub, Link App, Sync App, Investigator App) contact MC10, Inc. When new software versions are available the mobile applications will instruct you or the subject through the upgrade process.
  • Page 25 BioStamp nPoint User Manual Investigator In addition to the subject cleaning the Sensors with soap and water, the Investigator should clean all Sensors and all Medical Electrical equipment and certain accessories between each subject. To clean, simply wipe down each component (BioStamp Sensor, Link Hub, Power...

  • Page 26: Executing A Study

    Executing a Study...

  • Page 27: Investigator Portal Study Design

    BioStamp nPoint User Manual Investigator Portal Study Design The Investigator Portal will be used by the investigator and sanctioned users to design a study, view, and export data collected from study subjects. Computers used to access the Web Portal should be appropri-...
  • Page 28 BioStamp nPoint User Manual Add Prescribed Activites and Surveys Design Remote Programs to Guide Subjects Through Study Tasks Add Subjects and Subject Fields...
  • Page 29 BioStamp nPoint User Manual Remote Study Analytics In the Remote environment, you can also add Analytics for daily reports of subject activity, posture, sleep and heart rate. When analytics are activated, two pre-configured Sensors (anterior thigh with accel, Lead II with electrodes + accel) will be added to the Sensors field.

  • Page 30: Run A Supervised Study

    BioStamp nPoint User Manual Run a Supervised Study Investigators can design and run Supervised Studies to leverage BioStamp nPoint in more traditional clinical settings. Supervised Studies utilize the following components: Add Additional Subjects and Assign Sensors with Investigator Application Activate Bluetooth and connect to Wi-Fi on the provided tablet.
  • Page 31 BioStamp nPoint User Manual Open the Investigator App to run studies in the clinic or lab. Using the app, you can add additional subjects to the study and assign BioStamp Sensors to subjects. Apply Sensors to Subjects Once Sensors have been assigned to study subjects, follow the BioStamp Sensor application instructions (page 20) to adhere adhesives and secure Sensor placement on the body.
  • Page 32 The subject does not need to continue contracting the targeted muscle. Before beginning recording, you will need to review the Note BioStamp nPoint Terms and Conditions of Use and Privacy Policy with the patient and receive Subject Acknowledgement.
  • Page 33 Synchronize data from the Sensors by first placing the Sensors on the Link Hub. Place the Sync Phone in the Link Hub dock. Then log in to the Sync App with your BioStamp nPoint credentials to begin syncing Sensor data to the Investigator Portal.
  • Page 34 BioStamp nPoint User Manual Unassign and Power Off Sensors Once data has been synced, you may unassign and power off Sensors (for battery life preservation) in the Sensors tab on the Investigator App.

  • Page 35: Run A Remote Study

    Run a Remote Study Investigators can design and run Remote Studies to col- lect data outside of the clinic or lab. The BioStamp nPoint Remote Kit contains all the tools necessary to gather insights from a subject’s daily life or home environment.
  • Page 36 BioStamp nPoint User Manual Input this code into the subject’s Link App to associate the app with the subject’s study program and assign the Link Phone to the subject. This code will also be provided to the subject for logging in and out of the Link App.
  • Page 37 BioStamp nPoint User Manual Train the Subject and Send Them Home with BioStamp nPoint Remote Kit Remote Kit components are designed for Remote operational use by the subject. Train the subject on system use prior to sending the subject home with their Remote Kit and Subject IFU to initiate the study program.

  • Page 38: Subject Assessment And Data Analysis

    BioStamp nPoint User Manual Subject Assessment and Data Analysis Assess Subject Progress Open the Investigator Portal and click on the Subjects page to find the list of subjects that have been enrolled and their Gender (if entered), Age (if entered), Tasks Completed (%), and Data (linked to Raw Data and Analytics, if applicable).
  • Page 39 BioStamp nPoint User Manual Under the Data section of the subject’s profile, each recording is listed by Sensor. Click on the date and time of the recording for a raw signal visualization. Plots of raw data versus time can be visualized on the dashboard for each sensor signal and can be navigated to a specific timestamp, activity, survey, or annotation.
  • Page 40 BioStamp nPoint User Manual Access the Analytics Dashboard (Remote Studies Only) For a Remote study, you can click on the Analytics Icon in the subject profile to view the analytics reports for that subject. The Analytics icon brings you to a...
  • Page 41 Access the API for Specific Downloads Investigators can access the MC10 API through the API Docs link on the footer of the Investigator Portal or https:// mc10cloud.com/apidoc/. This is an interactive API tool that enables efficient data queries through the REST API.

  • Page 42: Troubleshooting And Manufacturer

    Troubleshooting and Manufacturer...

  • Page 43: Troubleshooting

    Bluetooth and Wi-Fi are connected. If both are connected, turn each of them off and on again. If the errors persist, force quit the MC10 application and restart the device. Contact the responsible organization if issues continue to occur.
  • Page 44 Appendix A...

  • Page 45: Biostamp Npoint Platform Components

    BioStamp nPoint User Manual BioStamp nPoint Platform Components BioStamp nPoint includes the following components: Instructions for Use Documentation Subject Instructions for Use for Re- mote Studies Link Hub and Power Supply BRSD01; BSPS01 (SL Power Electronics Model ME- 20A0900B02) Core Components...

  • Page 46: Technical Specifications

    BioStamp nPoint User Manual Technical Specifications BioStamp Technical Specifications Size Dimensions 7.1 x 3.4 x 0.5 cm (LxWxH max) Weight 8.7 grams Material Low durometer silicone Sensors Accelerometer Range ±2-16g0 ± 10% Bit Depth 16 Precision 0.6 mg Sample Rate 15.625-250 Hz ± 15% Zero-g Output ±60 mg...

  • Page 47: Biostamp Recording Modes

    BioStamp nPoint User Manual BioStamp Recording Modes Sample Rates Dynamic Ranges Sensor Available Available 15,625, 31.25, 62.5 125, +/- 2G, +/- 4G, +/- 8G, Accelerometer 250 Hz +/- 16G Gyroscope Range +/- 250°/s, +/- 500°/s, +/- 1000°/s, +/- 2000°/s Gyroscope + Acceler- 15,625, 31.25, 62.5 125,...

  • Page 48: Link Hub And Biostamp Sensor Frequency And Transmission Specifications

    BioStamp nPoint User Manual Link Hub and BioStamp Sensor Frequency and Transmission Specifications Frequency band of reception 2400-2500 MHz Bandwidth of reception 1 MHz Frequency band of transmission 2400-2500 MHz IEEE 802.15.1 direct sequence spread Transmission type spectrum (BLE), 0.015 mW EIRP No recurring testing is needed during the expected service life.

  • Page 49: Emc Declaration And Guidance

    EMC Declaration and Guidance Guidance and Manufacturer’s Declaration – Electromagnetic Emissions The BioStamp nPoint system is intended for use in the electromagnetic environment specified below. The customer or the user of the BioStamp nPoint system should assure that it is used in such an environment.

  • Page 50: Guidance And Manufacturer's Declaration - Electromagnetic Immunity

    BioStamp nPoint User Manual Guidance and Manufacturer’s Declaration – Electromagnetic Immunity The BioStamp nPoint system is intended for use in the electromagnetic environment specified below. The customer or the user of the BioStamp nPoint system should assure that it is used in such an environment.
  • Page 51 BioStamp nPoint User Manual Immunity Test IEC 60601 Test Compliance Electromagnetic Envi- Level Level ronment - Guidance Power frequency magnetic fields should be at levels characteristic of a typical location in a typical domestic environment. Electrical machinery Power Frequen- should be used no...
  • Page 52 BioStamp nPoint User Manual BioStamp nPoint User Manual Immunity Test IEC 60601 Test Compliance Electromagnetic Envi- Level Level ronment - Guidance 0%, 0.5 Cycles Voltage Dips, Short Inter- 0%, 1 Cycle ruptions and Mains power should Voltage Varia- 70%, 25/30 <70%...
  • Page 53 BioStamp nPoint User Manual Appendix B...

  • Page 54: It-Network

    BioStamp nPoint User Manual Programmable Electrical Medical System (PEMS) connection to an IT-Network Data is transferred continuously among components during normal system operation. Raw (unprocessed) sensor data is transferred wirelessly from the patch to the mobile through Bluetooth LE. When network connectivity is available, sensor data is transferred from the mobile to the cloud.

  • Page 55: Hazardous Situations

    (firewalls, VPC, access restrictions, and automated configuration management). Access to the data is restricted at multiple levels and is protected by MC10’s Access Control Lists (ACLs) framework. ACLs restrict resource availability to approved users and groups. Each user belongs to at least one group and is assigned one or more roles within their respective group.
  • Page 56 • Erroneous data transfer between Investigator Portal, Investigator App, and/or Link App and MC10 Cloud; • Data corruption on MC10 Cloud due to foreseeable misuse (i.e. hacking); • Investigator App or Link App can’t configure/control BioStamp Sensor; • Link Hub cannot control/download BioStamp Sensor;...

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