Summary of Contents for MJN NEURO MJN-SERAS Epilepsy
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Page 1: Document Update
USER MANUAL Ver. 18 February 2021 MJN Neuroserveis S.L. Av. Juan Carlos I, 184 bajos derecha 17300 Blanes (Girona) Spain Phone: +34 972 966 175 | info@mjn.cat | www.mjn.cat F-029_20_00018 – 15/02/2021... - Page 2 USER MANUAL 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.
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Page 3: Table Of Contents
USER MANUAL 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: ................................ - Page 4 USER MANUAL 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 ...........................
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Page 5: General Information
USER MANUAL 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. - Page 6 USER MANUAL to the manufacturer: info@mjn.cat. The manufacturer will proceed accordingly. 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 usage, notify it as soon as possible to the manufacturer: info@mjn.cat.
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Page 7: 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... -
Page 8: Classification Une-En 60601-1: Electro-Medical Equipment
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. -
Page 9: Previous Considerations
USER MANUAL 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. -
Page 10: Features And Technical Specifications
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... -
Page 11: Bluetooth / Communication
USER MANUAL 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 ▪... -
Page 12: Electromagnetic Compatibility (Emc)
USER MANUAL Part Raw material DLP mould Resine RC rubber + axis Axis + rear case + cover 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. - Page 13 USER MANUAL 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 Compliance level Electromagnetic environment –...
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Page 14: How To Use
USER MANUAL 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: •... -
Page 15: First Steps
USER MANUAL 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. -
Page 16: Switching Off The Device
USER MANUAL 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. - Page 17 USER MANUAL 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.
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Page 18: Unpairing The Device
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 F-029_21_00018 –... - Page 19 “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 •...
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Page 20: Usage Of The Application
USER MANUAL 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. -
Page 21: User Warnings
USER MANUAL User warnings This module will perform correctly after the “device activation” done by the technicians from MJN. The alerts will be displayed when the risk level of the user is high and a seizure is likely to appear. The seizure alert will appear as a dialog to confirm the last seizure or to classify it as a false positive. - Page 22 USER MANUAL In case of connection loss with the device, the application will activate a vibration and a sound warning. It will be possible to cancel it by pressing “OK” and the phone will try to pair with the device again This can happen due to an excessive communication distance or due to disconnection.
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Page 23: Activation
USER MANUAL ACTIVATION This procedure is performed by the technicians of MJN in collaboration with the user. Once the device has been received, it is ready to be used and record the user’s electrical activity. To customize the algorithm effectively it is necessary to use the device daily and record a minimum number of 5 seizures. -
Page 24: Care And Conservation
USER MANUAL CARE AND CONSERVATION Keep the device protected from hits and excessive pressure. Keep the device safe while not using it. Do not leave it exposed to the weather, the internal circuits could get wet. Do not leave it exposed to the sun, it could overheat. Cleaning Clean the earpiece regularly and the electrodes with a wet wipe. -
Page 25: Anomaly/Cause/Solution
Check the state of the charger cable. Try another charger cable. Check the 220V supply or the USB port. Check the connection to the MJN-SERAS Epilepsy port. Don´t use the device if it can´t be charged. Take care of the charger and the connector. -
Page 26: Application
If it doesn´t work, search manually the application “MJN-SERAS_Epilepsy” at the Play Google Store. Verify that the operating system version is compatible with MJN-SERAS Epilepsy. Update the operating system. In case of having compatibility issues after installing the last version, try with another mobile device or phone. -
Page 27: Operation
OPERATION The application can’t collect EEG data Check that the distance of MJN-SERAS Epilepsy to your device is within the 5-meters range. Verify the connection of the Bluetooth communications in the mobile device. Verify that the memory of the device isn’t full. - Page 28 USER MANUAL F-029_21_00018 – 15/02/2021 User_manual Pag. 28...
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Page 29: Mobile Device Or Phone
USER MANUAL The application doesn´t produce any kind of alarm. Verify that the MJN-SERAS Epilepsy device is connected. Check the state of the electrodes, clean if necessary. Verify the correct update of the personal information. Verify the correct update of the personal configuration.
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