SYSTEM (3).pdf · ASSIGN AND APPLY SENSORS Using the Investigator Application, the researcher can...

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AN INTRODUCTORY GUIDE TO THE SYSTEM Reshaping Research ®

Transcript of SYSTEM (3).pdf · ASSIGN AND APPLY SENSORS Using the Investigator Application, the researcher can...

Page 1: SYSTEM (3).pdf · ASSIGN AND APPLY SENSORS Using the Investigator Application, the researcher can assign BioStampRC Sensors to each body location included in the study protocol. ...

AN INTRODUCTORY GUIDE TO THE

S Y S T E M

Reshaping Research

®

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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

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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.

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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.

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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%

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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.

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®

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.

The Bluetooth® word mark and logos are registered trademarks owned by Bluetooth

SIG, Inc. Other trademarks and trade names are those of their respective owners.

Contact us to learn more at

[email protected]