MJN NEURO MJN-SERAS Epilepsy User manual
USER MANUAL
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Document update:
Ver. 1
02-07-18
Structure and content of the manual
Ver. 2
02-03-18
Manual structure
Ver. 3
23-04-18
Revision of the features and How to Use
Ver. 4
06-07-18
Extension of the working conditions and regulations
Ver. 5
24-08-18
Images and mobile application (APP)
Ver. 6
30-08-18
Symbols and warnings updates
Ver. 7
20-09-18
Warnings and technical specifications update
Ver. 8
27-09-18
Technical specifications update
Ver. 9
10-10-18
Specification of Previous considerations
Ver. 10
05-11-18
Modification of “Previous considerations” & addition of the contact details of MJN
Neuroserveis, device manufacturer.
Ver. 11
22-11-2018
Update of Alerts & warnings. Addition of UNE-EN 60601 classification.
Warning that this is a device that uses high frequency radiation, compatible with Wi-Fi
bands.
Ver. 12
24-06-2019
It is added the CE marking at this User manual and updates the NB’s number.
Ver. 13
20-09-2019
Alerts and warnings are added in compliance with EN / UNE EN 60601-1-2:2015.
Ver. 14
03-02-2020
It has specified that any serious incident should be report to National Competent
Authority of the country too.
It is corrected class BF device symbol.
It is added warnings and side-effect due to discomfort feeling.
Ver. 15
24-03-2020
Screenshots have been updated; previously some were in other languages.
It has been removed the “Seizure reports” chapter.
Old blue LED has been substituted by current green.
New chapter “Checking if the device is operating”.
Chapter “Switching off the device” has been updated.
Chapter named “Assessing the seizure risk level” has a new screenshots.
Ver. 16
16-09-2020
“Contraindications” clause is updated, including contraindications previously
documented as a warning.
It has been specified the indispensable need to use the medical device together with the
user's smartphone in "Essential Operation", as well as, it has been included quantitative
clinical data related to the operation and efficacy of the medical device.
The warning related to possible discomfort feeling during first days is replaced.
It is included the applicable regulation as medical device, in the chapter "General
information".
It is added new instruction for Anomaly/Cause/Solution.
Ver. 17
07-10-2020
It is correctly specified the intended use to improve the understanding. It is added new
warning related with individual use of the device.
Ver. 18
15-02-2021
It is added a warning related with the need of turn-off of the APP when device is been
switched-off.
Created by
Name: Xavier Raurich
Charge: COO
Signature:
Date:
Revised by
Name: Fernando Atienza
Charge: Technical Manager
Signature:
Date:
Approved by
Name: David Blánquez
Charge: Manager
Signature:
Date:
USER MANUAL
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Content
Document update:...................................................................................................................................... 1
Content ....................................................................................................................................................... 3
GENERAL INFORMATION ............................................................................................................................ 5
ALERTS AND WARNINGS ........................................................................................................................................5
CONTRA-INDICATIONS............................................................................................................................................7
ESSENTIAL PERFORMANCE.....................................................................................................................................7
CLASSIFICATION UNE-EN 60601-1: Electro-medical equipment............................................................................8
INTENTED USE ........................................................................................................................................................8
PREVIOUS CONSIDERATIONS..................................................................................................................................9
FEATURES AND TECHNICAL SPECIFICATIONS: .......................................................................................... 10
General:............................................................................................................................................................... 10
Sensor technology............................................................................................................................................... 10
EEG sensor........................................................................................................................................................... 10
Accelerometer..................................................................................................................................................... 10
Bluetooth / Communication................................................................................................................................ 11
Battery................................................................................................................................................................. 11
Compatibility ....................................................................................................................................................... 11
App software ....................................................................................................................................................... 11
Bio-compatibility ................................................................................................................................................. 11
Electromagnetic compatibility (EMC).................................................................................................................. 12
HOW TO USE............................................................................................................................................. 14
CONTENT ............................................................................................................................................................. 14
FIRST STEPS.......................................................................................................................................................... 15
Charging........................................................................................................................................................... 15
Device initialization ......................................................................................................................................... 15
Checking if the device is operating.................................................................................................................. 15
Switching off the device .................................................................................................................................. 16
IMPORTANT: whenever we remove the headset we must turn off the mjn-SERAS app. Otherwise the system
will believe that what it records is user's brain activity data, and will prevent the algorithm from correctly
assessing the risk of seizure. ........................................................................................................................... 16
Starting the recording...................................................................................................................................... 16
Stopping the recording.................................................................................................................................... 16
PAIRING WITH THE DEVICE.................................................................................................................................. 16
UNPAIRING THE DEVICE ...................................................................................................................................... 18
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USAGE OF THE APPLICATION............................................................................................................................... 20
Assessing the seizure risk level........................................................................................................................ 20
User warnings.................................................................................................................................................. 21
ACTIVATION......................................................................................................................................................... 23
USE OF DATA ....................................................................................................................................................... 23
MANTEINANCE .................................................................................................................................................... 23
CARE AND CONSERVATION ................................................................................................................................. 24
Cleaning........................................................................................................................................................... 24
TRANSPORTATION AND STORAGE CONDITIONS...................................................................................... 24
SALES CONDITIONS ................................................................................................................................... 24
ANOMALY/CAUSE/SOLUTION................................................................................................................... 25
DEVICE ................................................................................................................................................................. 25
APPLICATION ....................................................................................................................................................... 26
OPERATION.......................................................................................................................................................... 27
MOBILE DEVICE OR PHONE................................................................................................................................. 29
USER MANUAL
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GENERAL INFORMATION
MJN-SERAS Epilepsy is a medical device, classified as class IIa, which has obtained the CE conformity
certification by the notified body nº 2797, in application of European Directive 93/42/EEC and Spanish
Royal Decree RD 1591/2009.
ALERTS AND WARNINGS
Consult the usage instructions
This manual is supplied with a new and unused product. You can request them via
Neuroserveis.
Non-sterile product
Fragile, handle with care.
Avoid falls and hits on the product.
Do not use if the package is damaged
If you receive the product with a damaged label or packaging, please notify the
manufacturer immediately and wait to use the device until indicated by MJN
Neuroserveis.
Keep dry
Don’t expose the device to humidity, and do not dip it into water or other liquids.
Temperature limits between 0 a 50°C
Do not expose it to extreme temperatures.
Protect the device from the sun when not in use.
Humidity limit, in absence of condensation, 0 to 90%
To ensure the safety of use of the device, observe the conditions of CARE AND
CONSERVATION and the CONDITIONS OF STORAGE in this manual.
Do not try to open or repair the device or its components. The works on the device
will be only performed by qualified staff from MJN Neuroserveis.
Avoid bending the device in excess or making inadequate movements in order to
avoid damages.
Clean regularly the earpiece with a wet towel, do not apply other liquids.
Every time you wear it, ensure that the communications with the Smartphone are
correct (see PAIRING WITH THE DEVICE).
The device is safe to use by pregnant women and children over twelve.
Avoid exposure to electromagnetic fields or electrical voltages.
In case of observing an incorrect operation of the device, notify it as soon as possible
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In this way, any serious incident should be report to MJN Neuroserveis and National
Competent Authority of the country.
In case of excessive heating up of the device during electrical charging or during
manufacturer will proceed accordingly.
At the end of its lifetime, recycle it according to the electronic device procedures,
placing it a recycling center in your city or handing it to a certified electronic waste
manager.
Keep MJN-SERAS APP updated to the last available version. Don’t postpone its update
without a justified cause. The unjustified delay could be the cause of failures in the
operation of the device.
Do not subject the equipment to electromagnetic interference outside the admissible
range, in which case could appear communication failures, which could cause the
device malfunction, altering its ability to comply with the provisions of its intended
purpose.
The device houses an internal battery for powering of the equipment. A type B Micro-
USB type charger with constant voltage and electric current is required for charging.
- Nominal voltage: 5.0 ± 0.05 Vdc.
- Initial charge current: 30 ÷ 60 mA.
Do not wet device, its degree of protection is IP22
The device will always be charged at times when the device is not used.
ATTENTION!!, the charge of the battery is incompatible with the use of the
device.
Device emits high frequency wireless signal, Bluetooth BLE, compatible with ISM
bands.
Do not use device if you have an infection in the ear canal
Do not use device if you have a skin lesion near the device influence area
During first days of using, it is possible to feel discomfort due to the presence of the
earpiece inside the ear canal. It is expected to disappear with the days.
Device for individual use, is not possible to share with other people.
Unwanted side effects
The appearance of unwanted side effects is not expected, in case of evidence of
adverse effects, or suspicion of this, please contact immediately with MJN
Neuroserveis by any means provided.
IMPORTANT: whenever we remove the headset we must turn off the mjn-SERAS app.
Otherwise the system will believe that what it records is user's brain activity data, and
will prevent the algorithm from correctly assessing the risk of seizure.
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CONTRA-INDICATIONS
It is not possible to use the device if you have an ear canal infection nor if you have a skin lesion near
the device.
MJN-SERAS Epilepsy is a device designed and indicated for patients diagnosed with epilepsy who meet
specific requirements in relation to the manifestation form of epilepsy in his/her own case. For users
who do not meet these requirements, the feasibility of using the device can be analyzed by the
technical team of MJN NEUROSERVEIS, establishing in such case, the additional necessary
considerations.
ESSENTIAL PERFORMANCE
The medical device MJN-SERAS Epilepsy require for its working, the user smartphone support (with
Android OS, according to chapter Compatibility) and the specific APP MJN-SERAS, as monitoring tool
and warning transmission.
According to results of the clinical investigation developed for medical device validation, it is possible
to expect a device total sensibility around of 96% (nº of detected seizures by the medical device in
relation with the clinically confirmed by Gold-standard, Video-EEG) and a specificity of 94% (it is a
measurement of the true negatives -real seizures absence- in time-windows of 15 minutes, in relation
with the clinically confirmed ones, through video-EEG).
The device has been developed to detect an epileptic seizure risk and warn when there is an elevated
risk of suffering a seizure in previously diagnosed patients.
However, a false warning when the patient is not suffering a seizure is not considered a risk for the
patient/user.
Keep in mind that severe electromagnetic disturbances could prevent the device from detecting an
epileptic seizure, affecting its Essential Performance. The user will have to take appropriate measures
to avoid this type of interference.
To guarantee or improve RF communications (Bluetooth), keep always a distance equal to or greater
than 30 cm with the source of disturbances.
It is not foreseeable the additional maintenance need to preserve the Basic safety and essential
performance properties in relation to the electromagnetic disturbances of the device, during the
device expected service life, in addition to the observation and compliance with the warnings
contained in this document and absence of damage at the structure and housings of the device.
USER MANUAL
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CLASSIFICATION UNE-EN 60601-1: Electro-medical equipment
Device protected against electric shock, in accordance with UNE EN 60601-1, with
classification type BF.
Protected applicable part: metallic sensors installed in the device for the measurement of the
electrical activity of the brain.
Power supply of the device: internal powering.
Watertight device that prevents the accidental entry of liquids inside the equipment (IP22).
Installation and use of the device: portable equipment for continuous operation installed in the user’s
ear canal by herself/himself, does not require the intervention of specialized personnel or previous
experience. Simply accommodate in the ear canal fitting with ergonomics (the mold has been custom-
made), according to the indications contained in this document.
INTENTED USE
The intended use of the MJN-SERAS Epilepsy product is the continuous assessment of seizure risk and
warning when there is an elevated risk of suffering an epileptic seizure in previously diagnosed
patients. This risk is shown in the application, displaying three risk levels. Low risk, medium risk and
high risk. The high risk warning is activated in a short period of time before its own apparition.
Approximately, one minute.
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PREVIOUS CONSIDERATIONS
For the usage of MJN-SERAS Epilepsy it is necessary a mobile device or a smartphone (with Android OS)
that has Bluetooth communications with low energy consumption (BLE) and access to the Internet, via
mobile data or Wi-Fi. In addition to the necessary use of a specific APP MJN-SERAS.
The user of MJN-SERAS Epilepsy should be a person between 12 and 65 years-old, both sexes, with
confirmed refractory epilepsy diagnosis according to international standards. The Epileptic seizures
must have a duration of more than 5 seconds and present some clinical manifestation clearly
observable in the patient (Criteria according to clinical trial accomplished in hospital conditions).
For the correct operation of the MJN-SERAS Epilepsy device, it is necessary to record epilepsy seizures,
a minimum of 5, to be able to do a personalized training of the risk level assessment algorithms for
each user. This procedure generates patterns for the subsequent evaluation that are stored in a
personal configuration file.
The MJN-SERAS Epilepsy device generates warnings for the user through a mobile device or
smartphone, these alerts are an indication about the seizure risk likelihood, compared with the
previous trained patterns in the algorithm . Depending on the quantity and quality of the recording of
the first seizures, the device quality of the assessment could improve or worsen.
These seizure assessment patterns can be updated with the recording of more seizures by the user.
The lifetime of this device is expected to last 3 years.
Device has been development to be used at Home healthcare environment, if you want to use in other
special environment must consult to MJN Neuroserveis using any of the available means of contact.
USER MANUAL
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FEATURES AND TECHNICAL SPECIFICATIONS:
General:
▪Size: H 50 x W 55 x D 25 mm
▪Weight: 9.5 grams (± 2 grams depending on size)
▪Working temperature: 0 to 50 ° C
▪Charging temperature: 0 to 45 ° C
▪Certificates: Bluetooth Smart (4.0), CE (pending)
▪Warranty: 2 years
▪Material: Thermoplastics, DLP
▪Scope of delivery: 1 x MJN-SERAS Epilepsy, 1x USB charging cable USB A to MicroUSB
▪Waterproof: No
▪Light warning: Yes
▪Degree of protection: IP22
Protection against medium solid bodies
Protection against dripping vertically inclined
water
Protection against contact between the fingers
and the moving interior parts. Protection against
the entry of solid objects with a diameter greater
than 12.5mm.
Dropping water droplets up to an angle of 15°
from the vertical and any direction should not
cause damage.
Sensor technology
▪Sensor types: 3 x electrodes, 1 x 3-axis accelerometer
▪Vital parameters: 2 x EEG channels
▪Sample Rate: 125 Hz
▪Wireless technology: Bluetooth Low Energy (4.0)
EEG sensor
▪Sensor Type: Ag/AgCl electrodes
▪Measurement method: Silver chloride electrode for electrochemical measurements, the
electrode is in contact with the skin, the principle is the conversion of ion current at the surface of
human tissues to electron current in the electrode
▪Measurement Accuracy: ± 2 µV
▪Measurement range: 0 to 2000 µV
Accelerometer
▪Sensor type: 3-axis linear accelerometer
▪Measurement Accuracy: ± 0.1962 m / s2
▪Scope: -39.24 to +39.24 m / s2
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Bluetooth / Communication
▪Version: Bluetooth Low Energy version 4.0 (BLE 4.0)
▪Frequency: ISM band 2.4 - 2.485 GHz
▪Transmission power: 4 dBm
▪Signal range: approx. 10 m
▪Connected number of devices: 1 device
▪Data rate: 50 Hz
▪Supported profiles: Battery Service, Device Information Service, EEG monitor Service
▪Cloud storage of EEG data: Safety protocol Https using ASCII files, protecting them by User &
Password
Battery
▪Type: 1x internal Lithium-ion battery cell
▪Runtime: about 18 hours
▪Charging time: about 1 hour
▪Standby time: up to 24 hours
▪Battery charger: 5VDC USB-based battery charger
▪Connector type: microUSB type B connector
Compatibility
▪Samsung Galaxy A3 (2017) - Android 8.0.0
▪Samsung Galaxy Core LTE Prime - Android 5.0.2
▪LG K10 –Android 8.1.0
App software
▪Acoustic warning: Yes
▪Visual warning: Yes
▪Data storage: Yes
▪Cloud synchronization: Pending
Bio-compatibility
▪All plastic materials in direct contact with the user skin are made of biocompatible material, on
accordance to UNE-EN ISO 10993-1.
USER MANUAL
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Part
Raw material
DLP mould
Resine
RC rubber + axis
TPE
Axis + rear case +
cover
PC
Electromagnetic compatibility (EMC)
The device maintains basic safety and essential performance when used in the electromagnetic
environment specified below. The customer or the user of the device should assure that it is used in
such an environment.
Emissions test
Compliance level
Electromagnetic environment –guidance
RF emissions CISPR 11
Group 1
The device uses RF energy only for its internal
function. Therefore, its RF emissions are very
low and are not likely to cause any
interference in nearby electronic equipment.
RF emissions CISPR 11
Class B
The device is suitable for use in all
establishments, including domestic
establishments and those directly connected
to the public low-voltage power supply
network that supplies buildings used for
domestic purposes.
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The device maintains basic safety and essential performance when used in the electromagnetic environment specified
below. The customer or the user of the device should assure that it is used in such an environment.
Immunity test
IEC 60601 test
level
Compliance level
Electromagnetic environment –guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2
±8 kV contact
±15 kV air
±2 kV, ±4 kV, ±6 kV, ±8
kV indirect contact
±2 kV, ±4 kV, ±6 kV, ±8
kV contact
±2 kV, ±4 kV, ±8 kV, ±15
kV air
Floors should be wood, concrete or ceramic tile. If
floors are covered with synthetic material, the
relative humidity should be at least 30 %.
Power frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
30 A/m
30 A/m
Power frequency magnetic fields should be at levels
characteristic of a typical location in a typical
commercial or hospital environment.
Radiated RF IEC
61000-4-3
&
Immunity to
proximity fields
(EN 60601-1-2
table 9)
10 V/m
80 MHz to 2.7
GHz AM
Modulation
&
9–28 V/m
385 MHz to
5.785 GHz
FM Modulation
Pulse
Modulation
10 V/m
80 MHz to 2.7 GHz AM
Modulation
&
3 V/m
1 GHz to 6 GHz AM
Modulation
&
9–28 V/m
385 MHz to 5.785 GHz
FM & Pulse Modulation
Portable and mobile RF communications equipment
should be used no closer to any part of the device,
including cables, than the recommended separation
distance calculated from the equation applicable to
the frequency of the transmitter.
Recommended separation distance
d = 1.2 √𝑃
d = 1.2 √𝑃80 MHz to 800 MHz
d = 2.3 √𝑃800 MHz to 2.7 GHz,
where P is the maximum output power rating of the
transmitter in watts (W) according to the transmitter
manufacturer and d is the recommended separation
distance in meters (m).
Field strengths from fixed RF transmitters, as
determined by an electromagnetic site survey A,
should be less than the compliance level in each
frequency range B.
Interference may occur in the vicinity of equipment
marked with the following symbol:
NOTE: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and
reflection from structures, objects and people.
A) Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile
radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To
assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be
considered. If the measured field strength in the location in which the device is used exceeds the applicable RF
compliance level above, the device should be observed to verify normal operation. If abnormal performance is
observed, additional measures may be necessary, such as re-orienting or relocating the device.
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HOW TO USE
CONTENT
1 Device MJN-SERAS Epilepsy
1 USB charger cable USB A to MicroUSB
1 Quick instruction manual
1 User card, model and codes
Packaging contents a sticker as quality seal, it is used to evidence:
•Passing of the quality controls.
•Product release.
•Product authenticity certification.
Do not use the device if the seal is not intact or in good condition.
Do not use other cable than the supplied one with the device, it could be a source of
malfunction.
Earpiece
Connector micro_USB
LED light
Adaptable connection
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FIRST STEPS
Charging
Connect the micro USB cable inside the lower connector to fully charge
the battery.
Insert the opposite end of the charger cable in a USB port in a phone
charger or computer.
The LED of the device will emit a red light.
The charge will be complete when the red light is switched off.
The charger cable can be disconnected.
Device initialization
Invert the position of the device, the micro-USB connector must be
facing upwards.
Tap the connector twice, consecutively.
The LED will emit a green light once, for three seconds.
The device has been correctly switched on.
Checking if the device is operating
Invert the position of the device, the micro-USB connector must be
facing upwards.
If the device is working normally the green led turns on, while the
device stays in that position.
x2
Invert
Invert
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Switching off the device
The device must be switched off using the application MJN-SERAS Epilepsy in the associated phone.
Consult the section “Unpairing the device”
The LED will blink a green light three times.
The device has been correctly switched off.
IMPORTANT: whenever we remove the headset we must turn off the mjn-SERAS app.
Otherwise the system will believe that what it records is user's brain activity data, and will
prevent the algorithm from correctly assessing the risk of seizure.
Starting the recording
Switch on the device
Bring the device to the selected ear, left or right, according to the instructions card in
the original packaging.
Insert the A part inside the ear-channel.
Insert the helix, B part of the earpiece, inside external fold of the auditory
pavilion.
Place the plastic case behind the ear.
Stopping the recording
Bring the plastic case to the front part of the ear.
Remove carefully the earpiece, firstly the B part, the helix, and finally, with a slight turn to the rear
part, the rest of the earpiece from the ear channel.
The device can now be switched off.
PAIRING WITH THE DEVICE
Check the compatibility of the operating system and Bluetooth communication module of your mobile
device or phone
Download in your mobile device or phone the MJN-SERAS Epilepsy application (Free). It will be
available for Android. Can be found in Google Play.
Connect the device MJN-SERAS Epilepsy and place it correctly in the ear channel, as indicated
previously.
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Start the application MJN-SERAS Epilepsy in your mobile device of phone.
The first time, you will have to log in to pair your phone, inserting the device number as “UDI” (user
name) and the “Code” (password), as provided by MJN.
Press the “Log in” button.
The mobile app will start searching for the
specified device.
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Check that the pairing has been completed successfully and that both channels, 1 and 2, appear as
green or red.
Wait the first minute, until the system has calibrated itself.
If no MJN-SERAS Epilepsy devices are found, check the connection and the
battery of the device. Start a new search by pressing the “OK” button.
UNPAIRING THE DEVICE
Select the settings button .
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Press the button “Power off” and accept.
You can also disconnect the device by logging out of the current session. In this case, the next time you
want to start it up, you will have to enter the “UDI” (username) and the “Code” (password) again.
Select the information button .
This screen shows de following information:
•Version of the MJN-SERAS Epilepsy app installed
•UDI of the paired device
•MJN-SERAS Epilepsy firmware version
•CE Notified Body
Press the button “Log out and exit” and accept.
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USAGE OF THE APPLICATION
Assessing the seizure risk level
The risk level assessment is evaluated using an artificial intelligence algorithm, applied to the personal
configuration of the user. This module will perform correctly after the “device activation” done by the
technicians from MJN.
The mobile app can indicate three possible states:
Low risk: The risk level is lower than a certain threshold, low enough to allow certain activities to the
user.
Medium risk: There is no significant risk.
High risk: Level above a threshold sensitive enough to detect all the seizures.
Table of contents
