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Legal & Safety Information (Byteflies Kit)

CE mark

Table of contents
  1. Introduction
    1. Intended Use
    2. Intended Users
    3. Clinical Indications
  2. Safety Information
    1. Warnings
    2. Package and Device Symbols
  3. Regulatory Information
    1. Declaration of Conformity
    2. Byteflies Kit Compliant Regulatory Standards

LAST UPDATED: October 14, 2020

Introduction

The Byteflies Kit (Model 1) is a wearable CE Class I medical device for continuous recording of non-invasive physiological and behavioral signals in healthcare and home settings. The Byteflies Kit instructions for use (IFU) contains all the information required for safe and correct use of the Byteflies Kit. This page summarizes relevant safety and regulatory information.

Byteflies Kit
The collective name for all components of the medical device.
Sensor Dot
A 2-channel biopotential and tri-axial inertial measurement device, indicated for recording electroencephalography (EEG), electrocardiography (ECG), heart rate (HR), respiratory rate (RR), electromyography (EMG), electrooculography (EOG), acceleration (ACC), angular velocity (GYR), and activity index (AI).
Sensor Patch
An interface between a Sensor Dot and the body. A Byteflies Kit comes with a specific Sensor Patch: the 4-wire Cradle (see the IFU(/docs/hcp/kit/) for more information).
Docking Station
A component that can charge up to 5 Sensor Dots and provide a secure communication gateway to the Byteflies Cloud to upload recorded data.
Byteflies Cloud
A secure data storage and processing system for data recorded by Sensor Dots.

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 Users that need continuous monitoring.

Intended Users

Trained Operator
A healthcare professional trained in the usage of Byteflies Kits and its accessories.
User
A patient or subject with a clinical need for biopotential and/or motion monitoring and/or their caregiver.

The Byteflies Kit and its accessories are intended to be used by Trained Operators who configure the Byteflies Kit and its accessories in a medical environment (e.g. hospital). Users are wearers of the Sensor Dot, not operators of the Byteflies Kit, and are 4 years of age or older. Once the correct set up is configured, the User can take the Byteflies Kit and applicable accessories home to continue recording data as instructed by the Trained Operator. The User may be required to return to the medical environment for removal or reconfiguration of Byteflies Kit components and accessories by the Trained Operator.

Clinical Indications

The Byteflies Kit and its accessories are intended for prescription use in the home, healthcare facility, or clinical research environment to acquire, record, and transmit physiological and behavioral signals from Users. It acquires, records and transmits electroencephalogram (EEG), electrocardiogram (ECG), heart rate (HR), respiratory rate (RR), electromyogram (EMG), and/or electrooculogram (EOG) signals, with optional accelerometer (ACC), gyroscope (GYR), and activity index (AI) signals. It only acquires these signals, no diagnostic claims are made about the User’s condition.

The Byteflies Kit and its accessories should not be used on Users that:

  • Have been diagnosed with or are suspected to have life-threatening conditions that could result in immediate danger;
  • Need to undergo an MRI scan or cardiac defibrillation;
  • Have an active implanted device such as a pacemaker, defibrillator, or vagal nerve stimulator;
  • Are between 0 and 3 years of age.

Safety Information

The following is important information for using the Byteflies Kit properly and safely. Carefully read this section before operating any component. The Byteflies Kit is a biopotential and motion recording device comprised of hardware and software that has been tested to assess its safety and effectiveness, and to establish substantial equivalence with predicate devices.

  • The Byteflies Kit cannot provide diagnoses. It only records physiological and behavioral signals as configured by and under the authority of the Trained Operator.
  • The Sensor Dot LED patterns only reflect battery status and operation mode. The LED does not reflect physiological status in any way and should never be interpreted as an indication of patient health.
  • The Byteflies Kit is designed to be operated by a Trained Operator. The User should always receive proper instructions from a Trained Operator before using any component of the Byteflies Kit.
  • The Sensor Dot, Sensor Patch, and Docking Station are only intended to be used by the User as instructed by the Trained Operator and the User cannot configure any component of the Byteflies Kit.
  • The data recorded by a Sensor Dot can only be used to asses heart, brain, muscle, or motion-related diseases when reviewed by a properly trained healthcare professional (e.g. a cardiologist, pulmonologist, neurologist, physiologist …).
  • Sensor Dots interface with the human body via Sensor Patches. Sensor Patches for monitoring of biopotential (ExG) signals are compatible with certain commercial ExG electrodes. These are not supplied as part of the Byteflies Kit. The use of any skin adhesives may cause mild skin irritation, such as redness, itching, or contact dermatitis in some Users. Consult the manufacturer of the ExG electrodes for more information.

Warnings

Do not use any component of the Byteflies Kit before reading these warnings, the IFU and -if applicable- a manual for the ExG electrodes or Byteflies accessories:

  • Do not use the Byteflies Kit if any component is damaged.
  • The Byteflies Kit is provided non-sterile.
  • Please verify the LED status indicators to avoid misuse.
  • If the Trained Operator or User experience any adverse events while using a Byteflies Kit, discontinue the use and contact Byteflies immediately.
  • Skin adhesives (either provided by Byteflies as an accessory or from a compatible 3rd party provider) should be replaced if they no longer stick firmly to the skin or as indicated in their respective manuals.
  • Similar devices may cause signal interference during data transmission. Avoid operating the Byteflies Kit near interfering devices.
  • Keep the Byteflies Kit away from children and pets. The Sensor Dot and Sensor Patch may present a choking hazard, never place or let anyone place a component of the device in their mouth.
  • If any component of the Byteflies Kit fails to operate after attempting all suggested troubleshooting steps, contact support as soon as possible.
  • The battery used in a Sensor Dot may present a risk of fire, explosion, or chemical burn if mistreated. Do not expose Sensor Dots 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 a Sensor Dot appears to be leaking, discolored, deformed, or in any way abnormal.
  • All components of a Byteflies Kit should be returned to the healthcare provider or study staff at the conclusion of the prescribed period of use.
  • Do not use a Sensor Dot on a User without first cleaning it according to the instructions.
  • Do not use a Byteflies Kit without first charging the Sensor Dot(s) and completing proper set up as described in the IFU.
  • Do not use a Sensor Dots on Users undergoing an MRI scan.
  • Do not use a Sensor Dots on Users undergoing defibrillation.
  • Do not use a Sensor Dots on Users with an active implanted device, such as a pacemaker, defibrillator, or vagal nerve stimulator.
  • Do not expose a Sensor Dot to strong sources of static electricity.
  • Do not expose a Sensor Dot to strong electromagnetic fields.
  • Do not leave a Sensor Dot on top of or next to other electrical equipment.
  • Do not submerge any component of a Byteflies Kit in liquid.
  • Do not clean a Sensor Dot with agents other than those listed in the cleaning instructions.
  • Do not damage any component of the Byteflies Kit through drops, violent shaking or crushing.
  • Do not allow Sensor Dots to come into contact with conductive materials, except when following instructions on how to recharge the battery.
  • Sensor Dot is not a toy. Usage on children older than 3 years of age should be under strict supervision of an adult.
  • Do not alter any component of the Byteflies Kit. Any modification 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 700 hPa or greater than 1080 hPa.
  • Do not use a Docking Station with a charger and charging cable other than the one supplied with the Byteflies Kit.

Package and Device Symbols

Symbol Description
Manufacturer
Date of manufacture
Catalog number
Serial number
CE marking of conformity
Waste Electrical and Electronic Equipment (WEEE) compliance
Warning
Consult accompanying user guides for detailed instructions.
User should consult the instructions for use.
Type BF Equipment (IEC 60601-1). Type BF is suitable for intentional external and internal application to the patient, excluding direct cardiac application. Type BF equipment has an F-type applied part. The applied part of the Byteflies Kit is the Sensor Dot component.
For prescription use only
Class II insulation
Keep the device dry; the presence of liquids may compromise the safety of the device.
The maximum and minimum temperature limits to which the device or accessory should be exposed during use.
The maximum and minimum humidity limits to which the device or accessory should be exposed during use.
The maximum and minimum atmospheric pressure limits to which the device or accessory should be exposed during use.
Protected against solid objects over 12.5 mm, and protected against dripping water when tilted up to 15 degrees from its normal position.
Includes RF transmitter; may cause RF interference.
Keep out of direct sunlight.
The device is MRI unsafe; do not use the device in a magnetic resonance (MR) environment.
Choking hazard for children ages 0-3 years.

Regulatory Information

Declaration of Conformity

The Byteflies Kit (Model 1) is in conformity with the essential requirements and provisions of the EU Medical Device Directive (MDD), Council Directive 93/42/EEC of 14 June 1993 concerning medical devices.

Byteflies Kit Compliant Regulatory Standards

C
The Byteflies Kit is compliant with this standard.
R
The Byteflies Kit references this standard ("in the spirit of").
Standard Implementation Title Remarks
93/42/EEC (MDD) (1993) C Council directive concerning medical devices  
2017/745 EU MDR (2017) R EU Medical Device Regulation  
2014/53/EU (2014) C Radio Equipment Directive  
EN ISO 13485:2016 C Medical Devices - Quality Management Systems - Requirements For Regulatory Purposes Harmonized version
FDA 21 CFR, part 820 C Quality system regulation for medical device, federal register  
EN ISO 14971:2012 C Application of risk management to medical devices Harmonized version
IEC 60601-1:2005 + A1:2012 (Ed.3.1) C Medical electrical equipment - Part 1: General requirements for safety EN 60601-1:2006/A1:2013 (Harmonized version)
ANSI AAMI ES60601-1:2005/(R)2012 And A1:2012 C Medical electrical equipment - Part 1: General requirements for safety IEC 60601-1 (Ed.3.1) Consensus version
IEC 60601-1-2:2014 (Ed. 4.0) C Medical electrical equipment - part 1-2: General requirements for basic safety and essential performance - collateral standard: electromagnetic compatibility - requirements and tests EN 60601-1-2:2015 (Harmonized version)
ANSI AAMI 60601-1-2:2014 (Ed. 4.0) C Medical electrical equipment - part 1-2: General requirements for basic safety and essential performance - collateral standard: electromagnetic compatibility - requirements and tests IEC 60601-1-2:2014 (Ed. 4.0) Consensus version
IEC 60601-1-11:2015 C Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment EN 60601-1-11:2010 (Harmonized version)
ANSI AAMI HA60601-1-11:2015 C Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment IEC 60601-1-11:2015 Consensus version
IEC 60601-1-6:2010 + A1:2013 C Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability EN 60601-1-6:2010 (Harmonized version)
IEC 60601-1-8:2006 + A1:2012 R Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems EN 60601-1-8:2007/ A11: 2017 (Harmonized version)
IEC 60601-2-26:2012 C Medical electrical equipment - Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalographs EN 60601-2-26:2003 (Harmonized version) IEC 80601-2-26:2019 is the state of the art version (publication date 05/2019)
IEC 60529:1989+ AMD1:1999+ AMD2:2013 R Degrees of protection provided by enclosures (IP code)  
IEC 62366-1:2015 C Medical devices - Part 1: Application of usability engineering to medical devices  
EN 62366:2008 C Medical devices - application of usability engineering to medical devices Harmonized version
EN 62304:2006/ AC:2008 C Medical device software - Software life cycle processes Harmonized version
IEC 62304:2006 C Medical device software - Software life cycle processes  
IEC 62304:2006/ Amd 1:2015 C Medical device software - Software life cycle processes Amendment 1  
EN 1041:2008 C Information supplied by the manufacturer of medical devices Harmonized version
EN ISO 15223-1: 2016 C Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements Harmonized version (Corrected version 2017-03)
EN ISO 14155:2011 C Clinical investigation of medical devices for human subjects – Good clinical practice EN ISO 14155:2011/ AC:2011 (Harmonized version)
ISO 10993-1:2018 C Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process EN ISO 10993-1:2009/ AC:2010 (Harmonized version)
ISO 10993-5:2009 C Biological evaluation of medical devices - Part 5: Test for in vitro cytotoxicity  
ISO 10993-10:2010 C Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization  
MEDDEV 2.7/1 Rev. 4 (2016) C Clinical Evaluation: Guide for manufacturers and notified bodies  
MEDDEV 2.12/1 rev 8 (2013) C Medical Devices Vigilance System  
MEDDEV 2.12/2 rev 2 (2012) C Clinical Evaluation - Post Market Clinical Follow-up  
MEDDEV 2.7/4 rev 12 (2010) C Guidelines on Clinical Investigation: A guide for manufacturers and notified bodies  
MEDDEV 2.7/3 rev 5 (2015) C Clinical investigations: serious adverse event reporting  
ASTM D999 (2015) C Test Methods for Vibration Testing of Shipping Containers  
ASTM D4728 (2017) C Standard Test Method for Random Vibration Testing of Shipping Containers  
ASTM D5276 (2017) C Standard Test Method for Drop Test of Loaded Containers by Free Fall  
ASTM D4169 (2016) C Standard Practice for Performance Testing of Shipping Containers and Systems  
ASTM D4332 (2014) C Standard Practice for Conditioning Containers, Packages or Packaging Components for Testing  
ASTM F2213 (2017) R Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment  
EN 300-328 V2.1.1 (2016) C Electromagnetic Compatibility and radio spectrum matters (ERM) - Wideband Transmission Systems - Data transmission equipment operating In The 2.4 GHz ISM band and using wide band modulation techniques V2.2.0 is on approval (DRAFT was published on 2017-11)
ISO/TR 21730 (2007) R Health informatics - use of mobile wireless communication and computing technology in healthcare facilities - recommendations for the electromagnetic compatibility (management of unintentional electromagnetic interference) with medical device  
IEC 62133-2 (2017) C Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary lithium cells, and for batteries made from them, for use in portable applications - Part 2: Lithium systems  
IEC 62281 (2016) C Safety of primary and secondary lithium cells and batteries during transport IEC 62281:2019 (Ed. 4.0) is the state-of-the-art version
UN DOT 38.3 C Safety of primary and secondary lithium cells and batteries during transport  
HIPAA (1996) R Health Insurance Probability and Accountability Act  
GDPR 2016/679 (2016) C General Data Protection Regulation  
RoHS recast Directive 2011/65/EU (2011) C Restricting the use of hazardous substances in electrical and electronic equipment Including amendment of Directive (EU) 2017/2102
WEEE Directive 2012/19/EU C Waste Electrical & Electronic Equipment (WEEE) Directive  
ISO/IEC 27001:2013 R Information technology - security techniques - information security management systems - requirements  
ISO 27799:2016 R Health informatics — Information security management in health using ISO/IEC 27002  
FDA Guidance (2002) R General Principles of Software Validation; Final Guidance for Industry and FDA Staff  
FDA Guidance (2016) R Applying Human Factors and Usability Engineering to Medical Devices  
FDA Guidance (2005) R Guidance for the Content of Pre-Market Submissions for Software Contained in Medical Devices  
FDA Guidance (2017) R Deciding When to Submit a 510(k) for a Change to an Existing Device  
FDA Guidance (2016) R Use of International Standard ISO 10993-1, “Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process”  
FDA Guidance (2019) R Safety and Performance Based Pathway  
FDA Guidance (2013) R Radio Frequency Wireless Technology in Medical Devices  
FDA Guidance (2018) R Content of Premarket Submissions for Management of Cybersecurity in Medical Devices (DRAFT)  
FDA Guidance (2016) R Postmarket Management of Cybersecurity in Medical Devices  
FDA Guidance (2016) R Unique Device Identification System: Form and Content of the Unique Device Identifier (UDI)  
FDA Guidance (2017) R Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling  
AAMI TIR 12 (2010) R Designing, testing, and labeling reusable medical devices for reprocessing in health care facilities: A guide for medical device manufacturers  
AAMI TIR 30 (2011 /(R)2016) R A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices  
AAMI TIR 69 (2017) R Risk Management of Radio-frequency Wireless Coexistence for Medical Devices and Systems  
FCC part 15 Subpart C C FCC: Rules and regulations for Title 47 (Telecommunications) Required for FDA only
EN 301489-1/17 C EMC Testing  
FCC Part 15 Subpart B C EMC Testing Required for FDA only
AIM 7351731 C Medical Electrical Equipment & System Electromagnetic Immunity Test for RFID Readers Required for FDA only
NBOG (2014) C Consensus paper for the Interpretation and Application of Annexes Z in EN ISO 14971 2012  
NBOG BPG 2014-3 (2014) C Guidance for manufacturers and Notified Bodies on reporting of Design Changes and Changes of the Quality System  

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