SYSTEM (3).pdf · ASSIGN AND APPLY SENSORS Using the Investigator Application, the researcher can...
Transcript of SYSTEM (3).pdf · ASSIGN AND APPLY SENSORS Using the Investigator Application, the researcher can...
TABLE OF CONTENTS
What Is the BioStampRC System? ............................................ 1
Is the BioStampRC System Right for My Study? .................... 4
How Does Incorporating the BioStampRC
System Influence the Study Process? ...................................... 6
Where Has the BioStampRC System Been Used? ................. 9
What Are the BioStampRC System Specifications? .............. 10
What If I Still Have Questions ..................................................... 11
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The BioStampRC System is an end-to-end research tool designed for targeted,
accurate, and seamless physiological data collection from across the human body.
Skin-worn BioStampRC Sensors collect raw movement and biopotential data.
This data is securely stored online for convenient analysis and download.
WHAT IS THE
SYSTEM
System Components
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Memory for on-board data storage between sync sessions
3-axis accelerometer and gyroscope to capture 6 degrees of freedom inertial sensing
Rechargeable battery to provide up to 3 days of sensing with each charge.
Skin-friendly 24-hour-adhesives designed for easy subject application and secure wear
Electrode pair for biopotential measurements
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BioStampRC SENSORS
BioStampRC Sensors can be placed on numerous
body locations for targeted data collection, and
their close coupling to the skin allows for improved
data capture from areas of the body not currently
accessible from strap-worn devices.
The Sensors are flexible, discreet, and conform
to the contours of the human body. They allow
study subjects to move comfortably through
regular activities in clinical or remote settings
while reducing observation error and improving
data capture.
BioStampRC Sensors provide raw kinematic
(motion) data from the 6-axis inertial measurement
unit (IMU) —an accelerometer and gyroscope—as
well as surface biopotentials—Static and Dynamic
Surface Electromyography (sEMG) and/or cardiac
activity—from the electrodes.
Each BioStampRC Sensor logs data directly to the
on-board memory until data is synchronized through
Bluetooth® to the cloud. BioStampRC Sensors are
rechargeable, with a recommended 24 hours of
wear before cleaning and recharge*.
*Sensor chargers, skin adhesives, and electrode contact gel are included with the purchase of a BioStampRC Kit.
INVESTIGATOR PORTAL
INVESTIGATOR APPLICATION
The BioStampRC Investigator Portal is a web-based tool
where researchers create studies, define study parameters,
and view and download data. The Investigator Portal
allows researchers and collaborators to review study
setup, progress, and data from anywhere, anytime.
MC10 provides cloud-based
storage and backup of study data
through the portal, which is accessible only through valid account credentials.
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The Investigator Application is run on an
MC10-provided Android TM tablet to execute
studies and can:
• Communicate with BioStampRC Sensors
• Add time-stamped annotations to recordings
• View live streaming data to verify signal quality
Researchers use the Investigator Application to
assign Sensors to subject body locations, power
them on and off, and start and stop recordings.The
application allows researchers and subjects to move
freely when collecting data, untethered by cables or
desktop devices.
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IS THE
SYSTEM RIGHT FOR MY STUDY?
The BioStampRC System was
designed to help researchers
capture data from multiple areas
across the body, unrestrained by
wrist or strap worn wearables and
bulky in-clinic devices.
MC10 has validated the following body locations for accurate data capture:
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One of the benefits of the small and flexible form-factor of BioStampRC Sensors is the ability to place
multiple Sensors on the body at once.* There’s no limit to the number of BioStampRC Sensors that
can collect data simultaneously. Each Sensor can be configured to record a different measurement
(accelerometer, gyroscope, biopotential, or a combination) at a different sample rate and range.
*MC10 is always adding newly validated regions, so if there is a region of the body you’re interested in testing that isn’t included on the BioStampRC body map, contact us.
MC10 has validated the following body locations for accurate data capture:
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HOW DOES INCORPORATING THE
SYSTEM INFLUENCE THE STUDY PROCESS?
The BioStampRC System
was built to integrate with the
research workflow and simplify
the data collection process for
both subjects and investigators.
DESIGN A STUDYTo start using the BioStampRC System,
the researcher logs in to the Investigator
Portal to create a new study. Next, the
researcher defines study parameters
by setting:
• The number of Sensors each subject will wear
• The location of the Sensors on the body
• The recording modes (Accelerometer, Gyroscope, Biopotential)
• Sample rate
• Range of each Sensor
The researcher can also add Surveys
for subjects to answer and Activities
for subjects to complete, which will
both appear as time-stamped
annotations in the data.
THE PROCESS
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CREATE SUBJECT PROFILESSubjects can be inputted into the BioStampRC System directly from the Investigator Portal
or in the Investigator Application run on the provided tablet.
To input subjects, the researcher provides a unique subject ID as well as answers
to additional fields as necessary.
ASSIGN AND APPLY SENSORSUsing the Investigator Application, the researcher can
assign BioStampRC Sensors to each body location
included in the study protocol.
Once Sensors have been assigned to a subject’s body
locations, the researcher applies the Sensors with the
provided adhesives and contact gel (if necessary).
COLLECT DATAWhen Sensors have been assigned and applied, the Investigator Application will display a
temporary data stream to help the researcher verify Sensor placement and signal quality.
After verification, the researcher starts recording from the Sensors. When the data collection
period is complete, the recording session can be stopped using the Investigator Application.
PREVIEW AND DOWNLOAD DATAThe researcher can log into the
Investigator Portal to preview the
raw data and download a CSV
data file for analysis.
SYNCHRONIZE DATAWhen a data synchronization session has been initiated, data will move through a Bluetooth®
connection from the Sensors to the tablet and be transmitted to the cloud via WiFi.
REMOVE AND RECHARGEOnce Sensors are removed from subjects,
the Sensors can be cleaned and placed on
the charger prior to data synchronization.
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WHERE HAS THE
SYSTEM BEEN USED?
The BioStampRC System has
been employed as a key tool in
several studies—from explorations
in capturing range of motion to
developing machine learning models.*
Two peer-reviewed papers featuring the BioStampRC System were accepted to the IEEE Engineering in
Medicine and Biology Conference in 2016:
McGinnis, R., Patel S., Silvaro, I., Mahadevan, N., DiCristofaro, S., Jortberg, E., Ceruolo, M., and Aranyosi, A. J. (2016)
Skin Mounted Accelerometer System for Measuring Knee Range of Motion. IEEE EMBC.
This study demonstrates how inertial sensors can be used to automate measurements of knee range-
of-motion, with performance similar to that of trained operators. This development enables long-term
monitoring of knee motion outside of clinical environments without the need for trained personnel or
identification of anatomical landmarks.
Patel, S., McGinnis, R., Silva, I., DiCristofaro, S., Mahadevan, N., Jortberg, E., Franco, J., Martin, A., Lust, J., Raj, M., McGrane, B.,
Petrillo, P., Aranyosi, A. J., Ceruolo, M., Pindado, J., Ghaffari, R. (2016) A Wearable Computing Platform for Developing Cloud-
based Machine Learning Models for Health Monitoring Applications. IEEE EMBC.
This study examines a new paradigm for continuous training of machine learning models to improve their
performance in diverse settings. Models trained on data from constrained settings (e.g. in-clinic) typically do
not generalize to real-world environments. The paper demonstrates how continuous training can be used to
improve model performance in unconstrained settings.
The BioStampRC System was also highlighted in a Science Advances Publication:
Liu, Y., Norton, J., Qazi, R., Zou, Z., Ammann, K. R., Liu, H., Yan, L., Tran, P. L., Jang, K., Lee, J. W., Zhang, D., Kilian, K. A., Jung, S.
H., Bretl, T., Xiao, J., Slepian, M. J., Huang, Y., Jeong, J., Rogers, J. A. (2016) Epidermal mechano-acoustic sensing electronics for
cardiovascular diagnostics and human-machine interfaces. SCIENCE ADVANCES 16 NOV 2016 : E1601185
This study examines an epidermal wearable for mechano-acoustic heart monitoring. In a discussion of
existing biometric sensors, BioStampRC is described as one of “the most advanced commercial
skinmounted devices.”
*Refer to the resources page on the MC10 website for an updated list of publications featuring the BioStampRC System.
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WHAT ARE THE
SYSTEM SPECIFICATIONS?
Technical Specifications
ELECTRODES (1-CHANNEL)
Range ................................. ±200 mV
Resolution ......................... 0.006 mV
Sample Rate ..................... 125, 250, 500, 1000 Hz +10%
POWER • Lithium polymer, rechargeable battery (15mAh)
• Wireless recharging using 13.56 MHz power transfer
• <120 Minute Recharge Time
WIRELESS COMMUNICATION • Bluetooth® Smart (BLE) enabled communication
MEMORY • 256Mbit (32MB) Memory Capacity
SENSOR WATER RESISTANCE • IPX7 compliant
CERTIFICATIONS • UL/CSA 60950-1
• Sensor: FCC Part 15 Subpart C
• Charger: FCC Part 18 Declaration of Conformity
SYNCHRONIZATION • Clock drift of <1 second over 24 hours
OPERATING TEMPERATURE • Sensor: 0-40° C, Charger 20-40° C
SIZE Dimensions ....................... 6.6 x 3.4 x 0.45cm (LxWxH)
Weight ................................ 7 grams
Material.............................. Low durometer medicalgrade silicone
SENSORS ACCELEROMETER
Range ................................. ±16g
Resolution ......................... 5 mg
Sample Rate ..................... 15.625, 31.25, 62.5, 125,250 Hz ±10%
GYROSCOPE
Range ................................. ±2000 °/s
Resolution ......................... 0.2 °/s
Sample Rate ..................... 15.625, 31.25, 62.5, 125,250 Hz ±10%
WHAT IF I STILL HAVE QUESTIONS ABOUT THE
SYSTEM
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Contact us at [email protected]
We can arrange a phone call or system demonstration to answer any questions
about the BioStampRC System components and study process.
®
10 Maguire Road, Building 3, First Floor, Lexington, MA 02421
www.mc10inc.com
MC10, Inc. reserves the right to make changes in specifications at any time without notice or
obligation and will not be liable for any consequences resulting from the use of this publication.
The BioStampRC System is not intended to prevent, treat, diagnose or cure any disease.
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