About the BioStamp nPoint System:
nPoint System Questions
Since our system provides raw data, the most appropriate validation is to compare the raw signals to known inputs (accelerations, rotations, voltages).
|Sensor||Precision (minimum detectable change)||Absolute Accuracy|
|Accelerometer||0.006 G||0.03 G|
|Gyroscope||0.18 deg/sec||3.5 deg/sec|
|Analog Front-End for Electrodes||Noise Floor of 100 uV RMS|
The sensor is IPX7 water resistant. The sensor communicates over Bluetooth LE over the 2.4 GHz ISM band. It shares radio frequency space with microwaves, cordless phones, Wi-Fi, other Bluetooth devices and potentially other radio transmitter. Be sure your equipment is away from any other radio transmitters to avoid interference.
The wearable sensor should be removed prior to external defibrillation or an MRI scan and should not be used in the presence of strong electromagnetic fields.
When starting a recording session, the Link App will select a sensor from the available on-dock sensors and prompt the user on where to place it. Subjects do not manually decide, and cannot influence, sensor placement.
At the end of a recording session a subject will remove their sensors, wash and dry them, and return them to the Link Hub, at which time charging and data synchronization will happen automatically. When the Link App has internet connectivity via Wi-Fi or cellular data, it will transfer the data from the Link Hub to the MC10 Cloud.
Sensors indicate their readiness to be used with their green status light once they are fully charged and have all their data synchronized to the dock. What each lED means:
- Solid green indicates the Sensor is on-dock, fully charged, empty of recordings and ready for use in a recording session
- Solid blue indicates the Sensor is charging or synchronizing data
- Flashing blue rapidly indicates which Sensor to be applied on the body
- Flashing blue and green indicates the Sensor's built in self-test detecting a hardware problem, please contact MC10 support for assistance.
- Flashing green every few seconds indicates the Sensor is off-dock, fully charged, empty of recordings and ready for use in a recording session
In the Remote Mode portion of a Study, Tasks are scheduled in a Remote Program for Subjects to perform. The scheduling can be coarse-grained (morning, afternoon, evening) or hourly (1pm, 2pm, etc). Each day of the Subject’s participation, the Remote Program’s schedule of Tasks will be presented to them in the Link App. The Subject may complete or skip any of that day’s Tasks at any time and in any order. There will be a general notification displayed on the phone on days that there are Tasks to be performed. There are no specific alerts or alarms for individual Tasks.
Subjects can be enrolled at any point before or after a Study has been Started until the Study has been Completed. They can be enrolled in the Investigator Web Portal or via the Investigator App.
MC10 ships Android tablets and phones that have been tested to work correctly as integrated parts of its products. Qualification factors include (but are not limited to): Bluetooth capabilities, screen resolution, and form factor. While you are free to install MC10 applications on any Android device you would like, MC10 does not encourage the use of third-party devices nor does it provide support for issues arising from their use. Potential issues with other devices include: differing aspect ratios (which may cause user interface issues), differing Bluetooth implementations (which may cause connectivity issues), or subject confusion. MC10 does not provide software that is compatible with iOS devices (iPhones, iPads).
You can use the Investigator App simultaneously on multiple tablets. It is important to be sure that all your tablets are logged in as users on the same account. Users on separate accounts will not be able to synchronize recordings started from other accounts.
Each sensor contains a real-time clock, backed by a quartz oscillator, that is set at the beginning of a recording session. MC10 calibrates the sensors to be accurate within 1 second over a 24-hour period. Raw data samples are time stamped as they are created and stored in the Sensors flash memory. Timestamps are stored in UTC as a count of microseconds since the UNIX epoch (January 1, 1970).
The real-time clocks contained in BioStamp Sensors are calibrated to 1 second over a 24-hour period. If a tighter synchronization of raw data is desired, a Subject can be instructed to perform a physical action such as a heel strike, body blow, or strong hand clap. These actions are intended to produce an acceleration signal spike that will show in all sensor recordings. A linear interpolation can be used to align raw data signals. We recommend that this be performed during a "time sync" Activity so that you can find that acceleration signal spike easily, via annotated markers in your raw data stream.
The BioStamp system supports live streaming of raw data to the Investigator App for signal validation and verification purposes. Live streaming is not available for any other purposes because of its impact on battery endurance and because radio interference can cause missed samples or data corruption.
A Sensor's real-time clock (RTC) is set at the start of a recording. Sensors do not communicate with each other or any other device during the recording to synchronize their clocks or for any other purpose.
MC10 does not provide support for the use of our apps on third party devices, and we do not distribute the Link, Sync or Investigator Apps on the Google Play Store, or any other app store. MC10 Apps come preloaded on the provided mobile devices. If you have a need to use an MC10 App on a third-party device, please contact MC10 Support. The use of MC10 software in this manner require you to test and qualify the Apps and their future updates.
In the Supervised portion of a Study, using the Investigator App, assign the Sensor to any location on any Subject in any Study. Close the data-preview view. On the Sensor-information page, open the "three-dots" menu in the upper right, and choose "Erase Sensor". Unassign the Sensor from the location.
In the Remote portion of a Study, MC10 intervention is required to delete any data from Sensors or Link Hub, please contact MC10 Support in this event.
A Sensor with a fully drained battery can take up to 2.5 hours to charge. All Sensors on the Link Hub will charge simultaneously.
A Sensor with a filled memory will take between 15 and 20 minutes to transfer its data to the Link Hub. Each Sensor on the Link Hub with transfer its data one at a time.
A Study can be “Supervised”, “Remote”, or comprise both. Raw data can be captured in all cases.
A Remote Study makes use of the Link App to interface with and easily guide subjects through Sensor application, daily Remote Program execution, and Sensor removal with a kit that is specifically provisioned to their unique Subject ID within a Study. When designing a Remote Study you can activate Analytics which utilize MC10 algorithms to provide Subject daily metrics (available for Remote Studies only).
A Supervised Study makes use of the Sync App and Link Hub to synchronize Sensor data to the MC10 Cloud recorded from any Subject in any Study in an Account. The Tablet’s Investigator App allows the Investigator to independently assign Sensors to body locations and start and stop individual Sensor recordings. Supervised equipment is not provisioned to any one Subject and can be used in the clinic or lab for data collection across multiple Subjects. Analytics cannot be activated in a Supervised Study.
In a Remote Study a Posture Check is automatically initiated after Sensor application. Since the Posture Check allows the algorithms to understand the orientation of the Sensors on the Subject relative to gravity, it is required every time Sensors are placed or replaced on a Subject. This means if a Sensor falls off all Sensors being worn must be removed, placed on the Link Hub for syncing and charging, and when “ready”, reapplied through the regular application process ending in a Posture Check.
On the device side, the BioStamp Adhesive can hold 56 oz/in which is 1.4x stronger than our previous generation product (BioStampRC).
On the skin side, the BioStamp Adhesive can hold 140 oz/in which is 4.1x stronger than our previous generation product (BioStampRC).
Automatic updates are not enabled and the Instructions for Use indicate that the operator should not change the OS.
The MC10 software automatically prompts the users to upgrade when updated versions are available; the user must accept those upgrades.
Data is collected locally on the Sensor. Once the Sensors are removed and placed on the Link Hub, raw data recordings are transferred and stored to the Link Hub's internal SD card in an encrypted format. Data is then uploaded to the MC10 cloud through internet connectivity (Wi-Fi or cellular). That data is deleted from the Link Hub and Sensors once the MC10 Cloud confirms completeness and correctness of the data upload.
Subject Survey and Activity responses, start / stop times, and other data related to Subject use is stored on the phone / tablet while it awaits uploading to the MC10 Cloud. That data is deleted from the device once the MC10 Cloud confirms its completeness and correctness.
The phone / tablet software has an "offline" mode where data is temporarily stored on the device if there is no internet connectivity. Data is transmitted and deleted once connectivity is restored.
As provided by MC10, GPS location services are not disabled, however they are not required for the operation of MC10 software.
The use of MC10 software requires the Bluetooth protocol to be enabled for the system to function correctly.
The phones / tablets provided by MC10 are standard Android devices. As provided by MC10, they are not locked down or restricted in any way, and they come with a few standard Android, Samsung, and AT&T applications. Those applications are not required for the use of MC10 software and you may remove, disable, or lock them out if desired.
Our API: Via TCP port 80 and port 443, MC10cloud.com, www.MC10cloud.com, prod.MC10cloud.com
Our CDN: Via TCP port 80 and port 443, cdn.MC10cloud.com
Network Time Protocol: Via UDP port 123, 0.north-america.pool.ntp.org
MC10 software does not make use of a VPN.
Data remains stored in the MC10 Cloud indefinitely.
Yes, they are IPX7. They can be immersed in water up to 1m deep for up to 30 minutes. This means a Subject can shower, swim, and sweat while wearing the Sensors.
Passwords can be reset at any time by using the forgot password link on the sign in page (https://mc10cloud.com/biostampnpoint).
The memory card in the Link Hub is 32 GB. It will store the transferred Sensor data until it is synchronized to the MC10 Cloud. A typical Link Hub can hold over 500 fully utilized Sensor recordings.
Each site will need to have enough physical inventory of BioStamp nPoint Remote kits to support their anticipated subject enrollment.To assign a kit to a subject, study staff will interact with the Investigator Web Portal to enroll a subject into the nPoint system.Once the Subject is enrolled the Investigator Web Portal will provide a unique passcode that can be used to log the Subject into the Link App (subject-facing mobile app).Once the passcode is entered into the Link App, the Subject will be associated with that Remote kit and can begin to use it.
When creating a new subject profile in the Investigator Web Portal, there are default Subject metadata fields, and the Investigator can choose to add additional fields. The default fields do not have to be filled in for the system to operate. PII and PHI should NOT be used for ANY subject fields. These default metadata fields are:
- Subject ID (field will accept any alphanumeric ID)
MC10 currently does not offer normative data as a service.
The dashboard will typically display 24 hours of data for a day starting at midnight through to midnight. If a subject wears their Sensors during sleep overnight (past midnight), the dashboard will display the entire night’s sleep metrics on the subsequent day. This means that the following day’s display will start at the time the subject fell asleep the night before.
The system can be configured to collect EMG. There is no filtering or other transformation of raw EMG data as it is recorded directly from the sensor’s electrode via the integral analog to digital converter.The Sensor captures biopotential signals at the user-specified sample rate. Similarly, the MC10 Cloud raw data is visualized and presented for download with no filtering or transformation. EMG raw data is only filtered during use of the table Investigator App to confirm proper operation and placement of the sensor.
BioStamp nPoint is an FDA cleared medical device with clinically validated Analytics that produce (among other outputs) Heart Rate and Heart Rate Variability metrics from cardiac biopotential data. It is not indicated for ECG and therefore does not have a user-selectable ECG configuration or visualization mode.The raw biopotential data collected from the Lead II chest sensor may be downloaded for secondary analysis.
The BioStamp nPoint data collected and sent to the MC10 cloud is de-identified and does not include any personally identifiable information or personal health information as defined by HIPAA. MC10 maintains this data in the MC10 Cloud indefinitely.