MC10 BioStamp nPoint User manual

Instructions for Use

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BioStamp nPoint User Manual

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BioStamp nPoint User Manual
Only

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BioStamp nPoint User ManualBioStamp nPoint User Manual
Table of Contents
Introduction, Safety, and Component Overview.....................................................6
System Description..................................................................................................7
Important Safety Information..............................................................................8
Indications for Use..................................................................................8
Contraindications....................................................................................8
Warnings....................................................................................................8
Precautions................................................................................................9
Storage and Handling............................................................................9
Device and Packaging Symbols and Markings..........................10
RegulatoryInformation........................................................................................13
Applicable Standards..........................................................................13
FCC Compliance Notication...........................................................13
BioStamp nPoint Platform Components.......................................................14
BioStamp nPoint Component Assembly and Function Overview.......15
Link Hub.................................................................................................. 15
Tablet.........................................................................................................16
SyncPhone..............................................................................................16
LinkPhone...............................................................................................17
BioStamp Sensors.................................................................................18
Adhesives.................................................................................................20
Maintenance.............................................................................................................24
Upgrading System Components.....................................................24
Cleaning and Disinfection.................................................................24
Executing a Study.................................................................................................................26
Investigator Portal Study Design......................................................................27
Run a Supervised Study.......................................................................................30
Run a Remote Study..............................................................................................35
Subject Assessment and Data Analysis..........................................................38
Troubleshooting and Manufacturer............................................................................42
Troubleshooting.....................................................................................................43
Manufacturer...........................................................................................................43
Appendix A..............................................................................................................................44
BioStamp nPoint Platform Components.......................................................45
BioStamp nPoint Component Service Life..................................45
Technical Specications.......................................................................................46
BioStamp Technical Specications.................................................46
BioStamp Recording Modes.............................................................47
Adhesive Technical Specications..................................................47

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BioStamp nPoint User Manual
Link Hub and BioStamp Sensor Frequency and
Transmission Specications..............................................................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
Implemented Protocols ......................................................................................54
Information Flow ..................................................................................................54
Hazardous Situations............................................................................................55

Introduction,
Safety, and
Component
Overview

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BioStamp nPoint User Manual
BioStamp nPoint is a wireless remote monitoring platform intended for use
by healthcare professionals and researchers for the continuous collection
of physiological data in healthcare and home settings. BioStamp nPoint is
designed to capture objective, real-world data from study subjects
participating in clinical or academic studies, and may be used wherever
collection of relevant data is needed.
BioStamp nPoint centers on body-worn BioStamp Sensors that can be worn
for up to 24 hours at a time in both laboratory (clinic) and home settings.
Investigators (either researchers or physicians) design studies and the data to
be collected using a web-based study conguration tool, called the
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 conguration 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.”The recharging and data transmission hub (“Link Hub”) is used to
recharge the sensors and synchronize data from the Sensors. BioStamp nPoint
includes an algorithm package that delivers a dashboard presentation of
processed metrics on general activity (including step count and activity
classication), heart rate, heart rate variability, posture (body position relative
to gravity), sleep, and respiration during sleep. The system is also capable
of surface electromyography and monitoring limb and body movements
during daily living and sleep. Data are transmitted wirelessly from the Sensors
through the Link Hub to the MC10 Cloud for storage, processing, and analysis.
System Description

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BioStamp nPoint User Manual
Important Safety Information
Indications for Use
The BioStamp nPoint system is a wireless remote monitoring system intended
for use by researchers and healthcare professionals for continuous collection
of physiological data in home and healthcare settings. These physiological
data include heart rate, heart rate variability, respiration rate, activity
(including step count and activity classication), and posture (body position
relative to gravity). The system is also intended for measurement of surface
electromyography and to monitor limb or body movements during daily
living and sleep. Data is transmitted wirelessly from the Sensors for storage
and analysis.
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 qualied healthcare professional, as an aid to diagnosis and
treatment. The device is not intended for use on critical care patients.
Contraindications
The device is not intended for use on:
• patients who have implanted pacemakers or debrillators
• patients with known allergies or hypersensitivities to adhesives or
hydrogel
Warnings
• The wearable sensor may cause mild discomfort, skin irritation, redness,
itching, rash or contact dermatitis in some individuals. The device should
be removed if any pain or discomfort occurs.
• Histories of skin irritations should be considered prior to placing the
wearable sensor on a patient
• The wearable sensor should not be applied to broken, damaged, or
• irritated skin.
• The wearable sensor should be removed prior to external debrillation or
an MRI scan and should not be used in the presence of strong
• electromagnetic elds.
• Keep Link Hub components, tablet, and mobile devices away from water
and other liquids.
• No modication of this equipment is allowed.
• Clinical validation has not been performed on children or on patients
who are pregnant or breastfeeding.

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BioStamp nPoint User Manual
Precautions
• The wearable sensor should be removed prior to external debrillation or
an MRI scan.
• Sensors and Adhesive Stickers are non-sterile. Adhesives are single use
only on a single patient.
• Do not apply the wearable sensor if it appears damaged
• Similar devices may cause signal interference during data transmission. If
you experience this aect, avoid operating near interfering devices.
• Do not wear the device over regions of the body with excessive body hair.
Excessive body hair should be removed prior to wear.
• No creams or lotions should be applied to the skin immediately prior to
application of the wearable sensor
• Keep the device away from children and pets. The device may be a
• choking hazard, and may be harmful if swallowed.
• If any component of the BioStamp nPoint system fails to operate after
attempting all suggested troubleshooting methods, contact your health
care provider and/or study sta immediately.
• The battery used in this device may present a risk of re, explosion or
chemical burn if mistreated. Do not expose to excessive heat or re. Do
not crush, puncture, or incinerate as doing so can result in re, explosion,
or the release of toxic gases. Do not use or charge if unit appears to be
leaking, discolored, deformed, or in any way abnormal.
• Return all components of the BioStamp nPoint system to your health care
provider and/or study sta 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
• Storage temperature range: 15 – 30°C
• Storage relative humidity range: 40 – 60% RH
• Ensure your hands are clean and dry before handling any system
• components. Gloves are recommended for healthcare professionals
when handling the wearable sensor.
Changes or modications made to this equipment not express-
ly approved by the party responsible for compliance could void
the user’s authority to operate the equipment. Note

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BioStamp nPoint User Manual
Device and Packaging Symbols and Markings
Meaning Symbol Description
Instructions for Use
To identify the location where the
operator’s manual is stored or to
identify information that relates to
the operating instructions. To indicate
that the operating instructions should
be considered when operating the
device or control close to where the
symbol is placed.
Manufacturer
To identify the manufacturer of a
product. This symbol shall be used
lled in all applications to dierentiate
it from ISO 7000-2497.
Use by Date
To indicate that the device should not
be used after the date accompanying
the symbol, for example on a medical
device or its packaging.
Ingress Protection
Rating
This symbol indicates the ingress
protection rating of the Link Hub
Catalogue Number
To identify the manufacturer’s
catalogue number, for example on a
medical device or the corresponding
packaging. The catalogue number
shall be placed adjacent to the
symbol.
Batch Code
To identify the manufacturer’s batch
or lot code, for example on a medical
device or the corresponding
packaging. The code shall be placed
adjacent to the symbol.
IP24

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BioStamp nPoint User Manual
Meaning Symbol Description
Serial Number
To identify the manufacturer’s serial
number, for example on a medical
device or its packaging. The serial
number shall be placed adjacent to
the symbol.
Choking Warning
Symbol
Keep out of reach of children; choking
hazard for children ages 0-3 years.
Electrical Safety
Classication
To identify a type BF applied part
complying with IEC 60601-1. The
BioStamp Sensor is a Type BF Applied
Part.
ON/OFF Symbol
To indicate connection to or
disconnection from the mains, at least
for mains switches or their positions,
and all those cases where safety is
involved. Each position, “ON” or “OFF”,
is a stable position.
For Indoor Use Only To identify electrical equipment
designed primarily for indoor use.
Follow Operating
Instructions
To signify that the instruction manual/
booklet must be read.
Temperature
Limitations
To indicate the maximum and
minimum temperature limits at which
the item shall be stored, transported
or used.
Upper Temperature
Limitation
To identify the maximum temperature
limit. The temperature value may be
shown adjacent to the symbol.

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BioStamp nPoint User Manual
Meaning Symbol Description
Lower Temperature
Limitation
To identify the minimum temperature
limit. The temperature value may be
shown adjacent to the symbol.
Direct Current
To indicate on the rating plate that
the equipment is suitable for direct
current only; to identify relevant
terminals.
Do Not Re-Use
To indicate that the item is for single
use only and must not be used more
than once, for example on packages
of medical disposables.
Humidity Limitation
To indicate the acceptable upper and
lower limits of relative humidity for
transport and storage.
Atmospheric Pressure
Limitation
To indicate the acceptable upper and
lower limits of atmospheric pressure
for transport and storage.

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BioStamp nPoint User Manual
Regulatory Information
Applicable Standards
Standard Description
IEC 60601-1 Labeling Requirements; Safety Testing
IEC 62366 Usability Engineering for Medical Devices
FCC Compliance Notication
The BioStamp nPoint System was veried 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.
This equipment has been tested and found to comply with the limits for a
Class B digital device, pursuant to part 15 of the FCC Rules. These limits are
designed to provide reasonable protection against harmful interference in
a residential installation. This equipment generates, uses and can radiate
radio frequency energy and, if not installed and used in accordance with
the instructions, may cause harmful interference to radio communications.
However, there is no guarantee that interference will not occur in a particular
installation. If this equipment does cause harmful interference to radio or tele-
vision reception, which can be determined by turning the equipment o and
on, the user is encouraged to try to correct the interference by one or more of
the following measures:
• Reorient or relocate the receiving antenna;
• Increase the separation between the equipment and receiver;
• Connect the equipment into an outlet on a circuit dierent from that to
which the receiver is connected;
• Consult the dealer or an experienced radio/TV technician for help.
The BioStamp Sensors comply with Part 15 of the FCC Rules. The included
Link Hub complies with Part 15 and Part 18 of the FCC Rules. Operation of
each device is subject to the following two conditions: (1) this device may not
cause harmful interference, and (2) this device must accept any interference
received, including interference that may cause undesired operation.

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BioStamp nPoint User Manual
Documentation Instructions for Use
Subject Instructions for Use for Remote Studies
Core Components
and Accessories
Link Hub and Power Supply
BioStamp Sensors
Adhesive Stickers
Adhesive Applicator
Investigator Web Portal (MDDS or MC10 Cloud)
Supervised Components
Tablet with Investigator Application and Tablet
Charger
Mobile Phone with Sync Application
Remote Components Mobile Phone with Link Application
BioStamp nPoint Platform Components
Remote components of BioStamp nPoint are intended for
operational use by the patient. Supervised components of
BioStamp nPoint are intended for operational use by
investigators.
Note
BioStamp nPoint includes the following components:

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BioStamp nPoint User Manual
BioStamp nPoint Component Assembly
and Function Overview
Link Hub
The Link Hub stores captured data from each Sensor on an internal SD
memory card. When the Link or Sync Phone is connected to the Link Hub,
data from the Sensors can be transferred via a cellular or Wi-Fi connection to
the MC10 Cloud.
To assemble the Link Hub with power supply, set the Link Hub on a at, stable
surface. Do not position the Link Hub so that it is dicult to unplug the power
supply cord. Plug the provided Link Hub power supply into the back of the
Link Hub, and insert the wall adapter plug end into a nearby outlet. To power
down, unplug the power supply cord from the Link Hub.
Ensure system components are fully charged before each use. Note
BioStamp nPoint includes a
charging platform, called the Link
Hub that holds and charges the
Link Phone (for Remote Studies),
Sync Phone (for Supervised
Studies) and the BioStamp
Sensors. The Link Hub also
synchronizes data from three
Sensors and the Phone
simultaneously.

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BioStamp nPoint User Manual
Tablet
The tablet is congured with the Android operating system (do not exchange
or alter) and the Investigator Application. The Investigator App is synchro-
nized to the study parameters set by the investigator in the Investigator Portal
any time a study is accessed. For Supervised Studies, the investigator uses the
Investigator App to assign Sensors to subjects and to initiate recordings.
Subject information in the form of activity tags and survey entries can be
entered using the 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 o the tablet by
holding down the power button and selecting the “power o” option.
Sync Phone
For Supervised Studies, BioStamp
nPoint comes with a Samsung
Galaxy Tab A tablet (and charger)
for running the Investigator App,
a tool used to communicate with
Sensors and run studies in the
clinic or lab.
For Supervised Studies, BioStamp nPoint
comes with a Samsung Galaxy J3
smartphone for running the Sync App,
used to upload study data collected in
the clinic or lab.

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BioStamp nPoint User Manual
The Sync Phone is congured with the Android operating system (do not
exchange or alter) and the Sync Application. To charge the Sync Phone, place
it in the phone dock on the Link Hub. Once an investigator is logged into the
Sync App, the app is congured to upload Sensor data from the Link Hub to
the MC10 Cloud. For full functionality, the Sync Phone must be connected to a
data network (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 o the
Sync Phone by holding down the power button and selecting the “power o”
option.
Link Phone
The Link Phone is congured with the Android operating system (do not
exchange or alter) and the Link Application. To charge the Link Phone, place
it in the phone dock on the Link Hub. Once a study subject is logged into the
Link App, the application is congured to the study parameters set by the
investigator in the Investigator Portal. The Link App displays a daily sched-
ule for the subject to complete including Sensor placement, survey entries,
prescribed activities, and Sensor removal. The Link App is also used to upload
Sensor data from the Link Hub to the MC10 Cloud. For full functionality, the
Link Phone must be connected to a data network (Wi-Fi, mobile, etc) and have
Bluetooth turned on.
You can generate a unique subject passcode on the Investigator Portal to use
to log in to the Link App. You can then provision a Remote Kit (Link Phone,
Link Hub, and Sensors) to a specic subject and track hardware status. Once
the subject has completed the prescribed program, you can reset the
hardware by following the reset instructions in the Link App settings menu.
For Remote Studies, BioStamp nPoint
comes with a Samsung Galaxy J3
smartphone for running the Link App,
used to guide subjects through study
activities and upload study data.

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BioStamp nPoint User Manual
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.
Sensor Coordinate System Sensor Back View
The Sensor can be placed in numerous orientations in various locations, and
multiple Sensors can be placed on a single person. Once activated using the
Investigator App or Link App, each Sensor operates independently, storing
data in its local memory. The data can then be transferred wirelessly for
display and subsequent analysis. The Sensor is designed for use cases
involving up to 24 hours of continuous wear.
BioStamp Sensors
The BioStamp Sensor is an extremely thin,
body-worn system designed to measure
and record biometric signals.
Inspect Sensors
Inspect all Sensors for damage prior to use.
Damage includes cracked, split, or broken encapsulation; exposed
electronics other than the electrodes; tears or splits in the device; or any
other deviation from the manufactured state that might impair
functionality. Do not use Sensors that have visible damage.

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BioStamp nPoint User Manual
Power Sensors On and O
To power Sensors on, simply place the
Sensors in the sensor pockets on the
Link Hub.
BioStamp Sensors are shipped in a powered-o state. The LED light in
the upper right corner of the Sensor will be solid blue when charging
and solid green when ready.
For long-term storage, Sensors should be powered o. Sensors can be
powered o using the Investigator App on the tablet. Remove the
Sensor from the Link Hub before powering o. Sensors will
automatically turn o 3 hours after being removed from the Link Hub if
they are idle/ready for use and not set to record or if they are not ready
for use.
Sensor Status Indications
Sensors are equipped with a rechargeable battery. Before the Sensors
can be used, the user must ensure they are fully charged.
Charge Sensors
Charge Sensors by placing them in the sensor pockets on the Link Hub.

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BioStamp nPoint User Manual
The adhesives are intended to adhere the Sensors to the body for up to 24
hours.
Under certain conditions the provided adhesive might not be sucient (e.g.
prolonged swimming, very intense exercise) to adhere the Sensors to the
body for the full 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 specic areas. MC10 recommends providing an
additional method of securing the Sensors to these body locations and for
use during certain activities.
Apply the Adhesive Stickers
to Sensors
Each adhesive will be pack-
aged individually in a sealed
foil pouch. Do not open the
adhesive pouch until you are
ready to apply the adhesive to
the Sensor.
Adhesives
BioStamp Sensors are applied to the body using disposable adhesives for
attachment that also contain hydrogel to optimize electrode contact to the
skin. These double-sided adhesives have a sensor-side and a skin-side and
should be applied to the Sensor using the provided applicator as a guide.
For locations outside of the required analytics sensor locations
(see Investigator Portal Study Design), extra means to secure
the sensors to the body are recommended (e.g. TegadermTM,
CobanTM wrap).
Note