Byteflies Byteflies Kit 1 User manual

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Borsbeeksebrug 22, 6th floor 1177 6th Avenue, 7th floor
2600 Berchem New York, 10036 NY
Belgium USA
Instructions for use
And technical documentation

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Device information

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Device information 2!
1.!Introduction 5!
1.1 Intended use 5!
1.2 Intended users 5!
1.3 Clinical indications 5!
1.4 Contra-indications 6!
2.!Safety information 6!
2.2 Warnings 6!
3.!Device description 8!
3.1 Included components 8!
3.2 Suggested Accessories 10!
3.3 Device LED light Notifications 10!
3.3.1 LED behavior Sensor Dot in the Docking Station 10!
3.3.2 LED behavior Sensor Dot outside the Docking Station 11!
3.4 Package and device symbols 11!
4.!Information for use for Healthcare Professionals 14!
4.1 Adhesives and Electrodes 14!
4.1.1 Applying adhesive electrodes to the body 14!
The optimal locations to place electrodes for EEG, ECG and EMG recordings. 16!
4.2 Using the Kit (Model 1.X.X) 16!
4.2.1 Software/Interface Operations 16!
4.2.2 Mechanical Operations 18!
4.5 Re-usability and Cleaning procedures 19!
4.6 Troubleshooting 21!
5.!Information for use for Patients 22!
5.1 Attention points for Patients 23!
6.!Maintenance, Storage and Disposal 23!

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6.1 Maintenance 24!
6.2 Transport and storage 24!
6.3 Service life 24!
6.4 Disposal 24!
7.!Technical and Regulatory information 25!
7.1 Technical specification of the Sensor Dot 25!
7.2 Regulatory information 26!
7.3 Declaration of conformity 36!

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1. Introduction
This is the manual for the Byteflies Kit (Model 1.X.X), a wearable Class IIa (EU) and Class II
(FDA) medical device for continuous recording of non-invasive physiological and behavioral
signals in healthcare and home settings. The Kit (Model 1.X.X) (referred to as platform further
on) consists of 3 main components: The Sensor Dot, the Docking Station, and the Sensor
Patch. The multisensor Sensor Dot can measure electroencephalography (EEG). Additionally,
the biopotential channels can be used to measure electrocardiography (ECG),
electromyography (EMG) and electrooculography (EOG) data. The Sensor Dot also records
motion data by means of an Inertial Measurement Unit (IMU) consisting of a triaxial
accelerometer and gyroscope. One Sensor Dot can be used for up to 24 hours and data is
uploaded to the Docking Station. The Sensor Dot is placed in the Sensor Patch, that is carried
around by the patient and connected to approved, commercial non-invasive electrodes that
are attached to the head in a partial 10-20 gold standard EEG configuration to measure
electrical brain activity; on the torso (ECG) or on a muscle (EMG), usually a limb, to measure
electrical activity of a subject’s heart or skeletal muscles respectively. This manual contains
all the information required for safe and correct use of the platform.
1.1 Intended use
The Byteflies Kit is a multisensor device intended to collect non-invasive physiological and
behavioral signals to be used in the clinic and/or home for subjects that need constant
monitoring.
1.2 Intended users
The platform is intended to be used by trained operators who configure the electrodes, the
Sensor Dot, the Sensor Patch and the Docking Station in a medical setting environment (e.g.
hospital).
Patients are regarded as wearers of the Sensor Dot, not users or operators of the platform.
The patient/subject will therefore be required to return to the medical setting for Sensor Dot
and Patch(es) removal by a trained operator. Therefore, all information in this manual is
intended for the operator (the healthcare professional).
1.3 Clinical indications
The Byteflies Kit is intended for prescription use in the home, healthcare facility, or clinical
research environment to acquire, record, and transmit physiological and behavioral signals
from patients. It acquires, records and transmits electroencephalogram (EEG),

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electrooculogram (EOG), electrocardiogram (ECG) and/or electromyogram (EMG) signals,
with optional accelerometer and gyroscope signals. It only acquires these signals; no
diagnostic claims are made about the patient’s condition.
1.4 Contra-indications
The platform should not be used for patients that have been diagnosed with, or are
suspected to have, life-threatening conditions that could result in immediate danger. The
Sensor Dot should not be used on patients that need to undergo an MRI scan or defibrillation
or have an active implanted device such as a pacemaker or defibrillator.
2. Safety information
The following is important information for using the platform properly and safely. Carefully
read this section before operating any component of the platform. The Sensor Dot is an
biopotential and motion device comprised of hardware that has been tested to assess the
safety and effectiveness and to establish substantial equivalence with the predicate devices.
● The platform contains no biopotential or IMU analysis capabilities and cannot
provide diagnoses.
● The Sensor Dot LED light patterns only reflect battery status and operation mode.
The lights do not reflect physiological status in any way and should never be
interpreted as an indication of patient health.
● The platform is designed to be operable by a healthcare professional. The patient
should always be walked through all required instructions before wearing the
Sensor Dot (see chapter 5).
● The Sensor Dot is only intended to be worn but not operated by the patient.
● The data recorded by the Sensor Dot can only be used in research of heart, brain or
muscle-related diseases when reviewed by a properly trained healthcare
professional ( e.g. a cardiologist, neurologist, physiologist).
● Biopotential electrodes (not supplied by Byteflies) may cause mild skin irritation,
redness or contact dermatitis in some patients. Consult information provided by the
electrode manufacturer for more information.
2.2 Warnings
Do not use the Sensor Dot before reading this manual and a relevant manual for EEG, ECG
and EMG electrodes.
● Do not use the Sensor Dot if any component is damaged.

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● The Sensor Dot is non-sterile. Electrodes are single use.
● Adhesive electrodes should be replaced if they no longer stick firmly to the skin.
● Similar devices may cause signal interference during data transmission. Avoid
operating near interfering devices.
● Do not place the electrodes on locations with excessive body hair. If needed shave
the location before placing electrodes.
● No creams or lotions should be applied to the skin prior to application of the
sensor.
● Keep the Sensor Dot away from children and pets. The Sensor Dot may be a
choking hazard and should not be swallowed.
● If any component in the platform fails to operate after attempting all suggested
troubleshooting methods, contact your healthcare provider and/or study staff
immediately.
● The battery used in the Sensor Dot may present the risk of fire, explosion or
chemical burn if mistreated. Do not expose to excessive heat or fire. Do not crush,
puncture, or incinerate as doing so can result in fire, explosion or the release of
toxic gasses. Do not use or charge if the Sensor Dot appears to be leaking,
discolored, deformed, or in any way abnormal.
● All components of the platform should be returned to the healthcare provider
and/or study staff at the conclusion of the prescribed period of use.
● Do not use the Sensor Dot on a patient without first cleaning it according to the
instructions (see section 4.5).
● Do not use the Sensor Dot without charging and proper setup of the platform as
described in this document.
● Do not use Sensor Dots during MRI scans.
● Do not use Sensor Dots with a defibrillator.
● Do not use Sensor Dots on patients with an implanted pacemaker or defibrillator.
● Do not expose the Sensor Dot to strong sources of static electricity.
● Do not expose the Sensor Dot to strong electromagnetic fields.
● Do not leave the Sensor Dot on top of or next to other electrical equipment.
● Do not submerge the Sensor Dot in liquid.
● Do not clean the Sensor Dot with agents other than those listed in the cleaning
instructions in this manual (see section 4.5).
● Do not damage the Sensor Dot through drops, violent shaking or crushing.

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● Do not allow the Sensor Dot to come into contact with conductive materials, except
when following instructions on how to charge.
● The Sensor Dot is not a toy. Usage on children should be under strict supervision of
adults.
● Do not put the Sensor Dot into the mouth under any circumstances.
● Do not alter the platform. Any modification of the platform is strictly prohibited.
● Do not use at temperatures lower than 15°C or greater than 35°C.
● Do not use where air humidity is lower than 10% or higher than 90%.
● Do not use in environments subjected to pressure lower than 700hPa or greater
than 1080hPa.
● Do not use a Docking Station with a charger and charging cable other than the one
supplied as part of the platform
3. Device description
3.1 Included components
The Kit (Model 1.X.X) or platform consists of the following 5 main components which are
provided together with the Instructions for Use and Technical Documentation (this
document):
● The Sensor Dot (Fig. 1) constitutes the main wearable sensor device. They can
continuously record 2 biopotential leads (ExG) and IMU. The Sensor Dot can
operate completely standalone by storing data on the onboard memory for 24
hours on a single battery charge. The Sensor Dot Includes LED indicators for
assurance of proper operation and other user interface elements (see 3.3). The
Sensor Dot provides clinically relevant and long-term signal acquisition capabilities
in a small and user-friendly form factor. The Sensor Dot is intended for use on
subjects who are 4 years of age or older as a general patient monitor and stores
physiological signals for later analysis by a qualified healthcare professional after
transfer of the data via the Docking Station’s Management Interface.
● The Docking Station (Fig. 2) with micro-USB Cable and included power supply (Fig. 5),
is used for reading out the memory of up to 5 Sensor Dots simultaneously and
charging the batteries. Sensor Dots attach magnetically to the Docking Station. The
acquired signals are digitized and can be downloaded from the Docking Station’s
Management Interface for storage and further review.
● The Sensor Patch (Fig. 3) is the interface between the Sensor Dot and the
electrodes. It attaches magnetically to the Sensor Dot and has 4 connectors that

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meet the requirements of DIN 42-802. During recordings, the Sensor Dot and Patch
can be held in the disposable Carrying Case supplied with the Kit (Fig. 4). The wires
protruding from the case are attached to the electrodes.

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3.2 Suggested Accessories
Commercially available electrodes (not supplied by Byteflies) can be connected to the
electrode interface of the Sensor Dot, as long as they are compatible with DIN 42-802
connectors, such as:
● Disposable EEG cup electrodes with compatible DIN connector (K032278)
● Disposable pediatric ECG adhesive electrodes (solid gel) with compatible DIN
connector (K090180)
● Disposable adhesive EEG/EMG electrodes with compatible DIN connector (K142159)
3.3 Device LED light Notifications
3.3.1 LED behavior Sensor Dot in the Docking Station
The Sensor Dot contains 3 LEDs (green, yellow, red) to notify the user about normal
operation, warnings, or errors, as shown below:
When the LED turns red in case of a critical error, please contact Byteflies by email at
[email protected] or call [phone].