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The IceCaps (IceCap 2, IceCap 2 Small, IceCap Neonate (Sizes XS, S, & M)) are medical devices used as EEG electrodes. They are used by Healthcare Professionals on a patient in case of neurological disorders with a short or long-term EEG record (up to 72 hours). IceCap 2 shall be placed on patients weighing at least 10 kg (22.05 lbs) and having a head circumference above 43 cm (16.93 inches). IceCap Neonate shall be placed on the head of babies, newborns and premature babies.

The IceCaps (IceCap 2, IceCap 2 Small, IceCap Neonate (Sizes XS, S, & M)) are medical devices used as EEG electrodes. The IceCaps are a single use cap which connects to the marketed EEG recorders using an IceAdapter or Touchproof adapter. The electrodes placement in IceCap Product line is done accordingly to the 10/20 system. The conductive tracks of the Flexible Printed Circuit are used to conduct EEG signals from the electrodes to the connectors. IceCap 2 shall be placed on patients weighing at least 10 kg (22.05 lbs) and having a head circumference above 43 cm (16.93 inches). IceCap Neonate (M,S,XS) shall be placed on the head of babies, newborns and premature babies.

The Neuronaute Plus is a system intended to acquire, store, archive, and periodically transmit physiological signals from the brain using a full montage array to enable review at a physician's office, hospital, or other remote locations. It allows remote access by users via the BioSerenity Cloud. The Neuronaute Plus and its associated software are intended to assist in the diagnosis of neurological disorders. The Neuronaute Plus and its components do not provide any diagnostic conclusions or automated alerts of an adverse clinical event about a patient's clinical condition. The Neuronaute Plus is intended to be used by trained healthcare professionals, technicians or patients above 15 years old. In case of a patient below 15 years old, Neuronaute Plus is intended to be used by a care giver. Adequate training is recommended for proper use of the device. Neuronaute IceCap 2 electrodes are able to be used on patients weighing at least 10 kg and having a head circumference above 43 cm. Neuronaute is not intended to replace direct communication with healthcare providers. The system data should not be used alone, but should be used along with all other clinical data and exams to come to a diagnosis. The BioSerenity Cloud allows the display of signals in the diagnosis of physiological disorders through the data collected by recording. The BioSerenity Cloud should allow the analysis and filtering of data in order to aid doctors in diagnosing neurological disorders.

The Neuronaute Plus is a non-invasive medical device which enables the acquisition, recording, storage and transmission of electrophysiological signals in order to analyze potential neurological disorders. The system is composed of the pieces of equipment listed below, and the Neuronaute Plus components are connected through Bluetooth and Wi-Fi. - -Neuronaute Plus (Core module): is a signal acquisition system: an electronical amplifier that records EEG, ECG, EMG, EOG and breathing signals via a connection to EEG caps which transmits the data to the Neuronaute mobile application and Cloud system. - -Neuronaute Plus IceCap extender : is a removable interface to connect the signal acquisition system to the IceCap and IceCap2 & 2 Small. - -Neuronaute Plus DB25 Extender : is a removable interface that can connect the signal acquisition system to any DB25-compatible EEG cap. - -Holding band : is a wearable textile band which allows the patient to place the Neuronaute Plus close around his chest over clothes. the use of the holding band is optional. - -Neuronaute IceCap: is a single use 21 electrode headset that connects to the Neuronaute Head Module via the IceAdapter, the DB25 cable and the Neuronaute BioAdapter, or Neuronaute Plus with its IceCap Extender. Recently, the Neuronaute Touchproof Adapter was developed to connect the IceCap electrode to Neuronaute Head module via a touchproof channel. - Neuronaute IceCap 2 & 2 Small: recently cleared version of the IceCap dedicated to adults and pediatric patients. It connects similarly to Neuronaute and Neuronaute Plus. - Neuronaute Mobile APP: is compatible with iOS systems. The mobile application enables the healthcare professionals to access and manage the prescribed recording sessions. - -Bioserenity CLOUD: is a web-based information system that receives the EEG signals from the recorder through a paired Wi-Fi connection. The cloud platform enables long-term storage and display of the recorded signals. The physician, who prescribes the use of this device, should monitor its use and confirm the proper functioning of signal recording through the Neuronaute Cloud. - -VEEG pack: it is composed of the Neuronaute N-DEO and Neuronaute N-WAY. The Neuronaute N- DEO camera enables the visualization of the patient during a recording. The IP camera provides HD resolution video sequence at 1080p, with advanced night mode and WDR technology. The Neuronaute N- WAY enables wireless connectivity (4G) for remote monitoring and data transmission to the cloud platform.

Neuronaute with IceCap 2 & IceCap 2 Small is a system intended to acquire, display, store, archive, and periodically transmit EEG signals from the brain using a full montage array to enable review at a physician's office, hospital, or other remote locations. It allows remote access by users via the Neuronaute N-CLOUD which receives EEG signals from Neuronaute Head Module which sends transmissions to the cloud. Neuronaute and its associated software are intended to assist in the diagnosis of neurological disorders. Neuronaute and its components do not provide any diagnostics conclusions or automated alerts of an adverse clinical event about a patient's clinical condition. The device is for use by trained medical professionals for patients under medical supervision. The device is intended for use on adults and pediatrics. Neuronaute is not intended to replace direct communication with healthcare providers. The system data should not be used alone but should be used along with all other clinical data and exams to come to a diagnosis.

Neuronaute with IceCap 2 & IceCap 2 Small is a system intended to acquire, display, store, archive, and periodically transmit EEG signals from the brain using a full montage array. The system includes the Neuronaute Head Module, IceCap 2 & IceCap 2 Small electrodes, battery, Bioadapter with the IceAdapter, mobile app, and the Neuronaute N-CLOUD. The IceCap 2 and IceCap 2 Small are single-piece flexible printed circuit headsets with 21 EEG sensors (19 EEG channels, 1 reference and 1 ground), 4 skin adhesive areas and 2 connectors. The electrodes are made of Ag/AgCl sensors connected via conductive silver ink and insulated with dielectric ink. The system allows remote access by users via the Neuronaute N-CLOUD. An optional video system composed by N-way and N-Deo is available.

Neuronaute is a system intended to acquire, display, store, archive, and periodically transmit EEG signals from the brain using a full montage array to enable review at a physician's office, hospital, or other remote locations. It allows remote access by users via the Neuronaute N-CLOUD which receives EEG signals from Neuronaute Head Module which sends transmissions to the cloud. Neuronaute and its associated software are intended to assist in the diagnosis of neurological disorders. Neuronaute and its components do not provide any diagnostics conclusions or automated alerts of an adverse clinical event about a patient's clinical condition. The device is for use by trained medical professionals for patients under medical supervision. The device is intended for use on adults (ages 18 and above). Neuronaute is not intended to replace direct communication with healthcare providers. The system data should not be used alone, but should be used along with all other clinical data and exams to come to a diagnosis.

Neuronaute allows up to 24 channels EEG monitoring. It includes the following components: Neuronaute Head Module, Neuronaute High Capacity Battery Module, Neuronaute BioAdapter, Neuronaute Mobile App, Neuronaute N-CLOUD, Neuronaute N-DEO, Neuronaute N-WAY, Neuronaute IceCap.

Cardioskin is intended to aid the diagnostic evaluation for cardiac disorders by recording patient's ECG signals allowing to condition and monitor these signals. ECG data is stored, transferred and displayed for a review by a physician. Cardioskin is designed to be used by a patient to transmit multiple-lead ECG signal to enable review at a physician's office, hospital or other remote locations under medical supervision. Cardioskin target population is adults.

Cardioskin is a wireless and wearable medical device. It enables acquisition, recording, storage, transmission and display of 3-12 leads electrocardiogram (ECG) to analyze potential cardiac pathological abnormalities from adult patients in healthcare facility, at home or clinical research environment. It is intended to be used by trained patients and healthcare professionals only. Cardioskin is composed of a garment, Cardioskin Textile, which is a T-Shirt where textilebased electrodes made of silver yarns are knitted and only functions on Cardioskin Battery and in association with a Cardioskin Recorder. Cardioskin functioning is coupled with a smartphone/tablet compatible with an iOS or Android system, and a mobile application, the Cardioskin App. A web-based information system, the Cardioskin Cloud, receives the ECG signals from the Cardioskin Recorder through a paired Wi-Fi connection for its long-term storage and display the signals in the web interface. The medical expert specialist, who prescribes the use of this device, should monitor its use and confirm the proper functioning of signal recording thanks to Cardioskin Cloud.

The Neuronaute is a medical, wireless and mobile equipment, which allows acquisition, record, storage, transmission and displaying of electroencephalogram (EEG) from adult patients. It can be used with patients in health care facility (data acquisition and reporting) or clinical research environment. The Neuronaute requires operation by a trained healthcare professional. The Neuronaute only acquires and displays physiological signals, no claims are being made for analysis of the acquired signals with respect to the accuracy, precision and reliability.

The Neuronaute is a wearable and wireless equipment, which allows acquisition, recording, storage, transmission and displaying of electroencephalogram (EEG). The Neuronaute is composed of a textile cap where twenty-one titanium dry electrodes are attached. An electronic box is attached to the cap (EEG recording) associated to batteries. The system operates on battery power only. The system is connected to a device (i.e. smart phone or a digital tablet) loaded with a separate stand-alone software program ("app"). The app works with a cloud backend service, which allows the user management and authentication, the data storage for application recordings and access to this data via a web-based interface, the devices management and authentication, the recording scheduling, the download of the latest firmware version. The acquired signals are saved in a universal data format (European Data Format, EDF) that is intended to be visualized by a Physician through the web-based interface.