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LED PHOTIC System is an accessory indicated for photic activation of brain during the electroencephalographic (EEG) studies. It always has to be used in combination with an EEG system, in order to evaluate particular anomalies of the brain activity due to the intermittent photic stimulation. The product must be used only by qualified personnel (physicians or technicians of neurophysiopathology) for the execution of EEG exams in a professional environment.

LED PHOTIC System is an accessory indicated for photic activation of brain during the electroencephalographic(EEG) studies. It is to be used in combination with an EEG system, in order to evaluate particular anomalies of the brain activity due to the intermittent photic stimulation. The LED PHOTIC Systemis managed by the EEG system software for setting some parameters, IC, and the power supply called LED PHOTIC IC POWER is an integral part of the LED PHOTIC System.

The SD LTM STIM is a low power, constant current, bi-phasic stimulator intended for cortical stimulation during electroencephalography examinations (i.e. stereoEEG). The stimulation is applied to the brain using third-party stimulation cortical or intracranial electrodes) and the resulting cortical or deep brain potentials themselves are recorded using third-party cortical or intracranial electrodes. The SD LTM STIM itself is an accessory to the SD LTM 64 EXPRESS Signal Acquisition System and SystemPlus EVOLUTION software. The stimulation parameters, the election and the activation of the stimulation current are all set-up and controlled from these devices. The SD LTM STIM can operate only when so connected and with the SystemPlus EVOLUTION software; it cannot serve as a stand-alone cortical stimulator.

The SD LTM is a low power, constant current, bi-phasic stimulator intended for cortical stimulation during electroencephalography examinations (i.e. stereoEEG). The stimulation is applied to the brain using third-party stimulation probes (including cortical or intraccanial electrodes) and the resulting cortical or deep brain potentials third-party cortical or intracranial electrodes. The use of these types of recordings can be related to the diagnosis/study of nervous system diseases.

The devices are intended to acquire and store physiological signals for EEG and Sleep Studies, and to transfer the data to separate polysomnographic analysis software. The devices are intended for use by physicians, technicians, or other medical professionals that are trained in EEG and/or PSG.

The device function is the acquisition of bloelectric signals, as is typical for EEG amplifiers and holter recorders. The device receives and amplifies patient input signals, converts them to digital format, packs them by a programmable logic and sends them to an internal microcontroller. The microcontroller stores them in a RAM buffer, from where they are written at defined time to the Compact Flash memory. The data can be viewed directly on the display or downloaded by using elther specific interface modules (BQUSB towards the USB port of the PC or BQNET towards an Ethernet link) or the built-in Bluetooth® link. Data can also be read directly from the Compact Flash card via a memory card reader. In PC a typical polysomnographic analysis software application manages the storage and the on-line or off-line display of the data. In the main version, the device is provided with 32 input channels: - 24 channels for EEG (BW: 0.15-220 Hz) . - DC channels (0-330 Hz) . - 2 channels for the built-in flow sensors . - 2 channels for external inductive belts (respiratory effort sensors) . - 1 channel for a built-in body position sensor . - 1 channel for digital data from the oximeter (SpO2, heart rate and plethysmographic signal) The device is enclosed in a (2.5 -> 3.5) h x 7.5 x 11.4 cm plastic case and weighs 200g. It is powered by 2 AA 1,5V alkaline batteries, by the BQUSB interface (via the connected PC) or the BQNET module (via separate AC mains adapter). The device has a LCD allowing the menu to be display gives information on the recording mode, acquisition time, remaining memory, impedance measure and allows the rough display of the acquired traces both on-line and after the recording. The user interface includes 4 membrane keys enclosed in the label below the display. The device has no patient contacting parts. Input signals are collected by commercially available accessories like EEG electrodes, oximeter sensors, cannulae and respiratory effort sensors (elastic band). The patient and operator can eventually touch the plastic external enclosure but the device is usually worn above the clothes in a synthetic fabric bag. The manufacturer does not intend to limit the utility of this device by listing a finite set of commercially available sensors. The device is only a recorder that receives and records input form sensors and subsequently downloads those recordings to a PC resident polysomnological application software for clinical analysis: it is very versatile in the range of input sensors that can be used in various sleep study dinical settings. The sensors, kits and application software are not intended in this application for dearance. For connection with the sensors and the PC, the devices are provided with: - touch proof connectors for patient electrodes (EEG channels) - touch proof (BRAIN SPY PLUS) or 3-pin connector (MORPHEUS/TITANIUM) connectors for DC channels - 1 screw-lock and 2 hose barb connectors for flow sensor cannulae (MORPHEUS/TTTANIUM version) - 2 connector for the resplratory effort elastic band (MORPHEUS/TTTANIUM version) - 3-pin (MORPHEUS/TITANIUM) or 4-pin (BRAIN SPY PLUS) connectors for the oximeter - 4 pin push-pull connector for the connection to the BQUSB or BQNET module. The communication lines with the BQUSB or BQNET module are optically isolated. In the PC data coming from either USB, Ethernet or Bluetooth® ports are then acquired by an acquisition software. The submitted device is supported by PC based application software such as Embla's Somnologica Studio (version 5.1), or Micromed's System Plus (version 1.03). The application software is not intended to be included in this application for clearance. Battery power is provided to make the device safer, ergonomic and able to acquire good signals even in electromagnetically nolsy environment. Low power consumption allows 24 hours of consecutive recording with a pair of standard alkaline battery. Maximum power consumption is 80-100 mA, plus 30 mA in wireless transmission mode. In stand-by, the power consumption is less than 100µA. When voltage and communication signals are present on the cable connection, the device is powered by the USB interface modules through a DC/DC converter. The device can also be connected to the PC through a radio (Bluetooth®) link using the RADIOEEG. built-in module. The microcontroller communicates with the radio module through Its serial port and transmits the data to a Bluetooth® receiver on the PC. The Compact Flash storage memory capacty determines the duration of the recording to the number of the channels used. The commercially available (1 GB) allow more than 24 hours recording of 32 channels at 128 Hz sampling rate, without data compression. If data compression algorithm Is used, recording time can be increased by 25-30%. The device family is composed of two basic models all sharing the same case, internal hardware and firmware. The BRAIN SPY PLUS model is obtained by a MORPHEJS model without the internal sensors and with a different input panel (less and different connectors). The Embla TITANIUM model Is identical to MORPHEUS, differing only in labeling (distributor brand and device name).