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The Orion LifeSpan™ MEG non-invasively measures the magnetoencephalographic (MEG) (and, optionally, electroencephalographic (EEG) signals) produced by electrically active tissue of the brain. These signals are recorded by a computerized data acquisition system, displayed, and may then be interpreted by trained physicians to help localize these active areas. The locations may then be correlated with anatomical information of the brain. MEG is routinely used to identify the locations of visual, auditory, and somatosensory in the brain when used in conjunction with evoked response averaging devices. MEG is also used to non-invasively locate regions of epileptic activity within the brain. The localization information provided by the device may be used, in conjunction with other diagnostic data, as an aid in neurosurgical planning. It is assumed that the users of the Orion LifeSpan™ MEG are physicians or neurology laboratory technicians who have received training in the following areas: • Hospital procedures • Physiological monitoring of patients • Training relevant to the specific discipline or disorder under investigation Note: This indication for use specifically excludes use of the Orion LifeSpan™ MEG as life support equipment, for example vital signs monitoring in intensive care units.

The Orion LifeSpan™ MEG is a magnetoencephalograph (MEG) which records magnetic signals from the human brain. The Orion LifeSpan™ MEG uses the CURRY software platform (K001781) to acquire, process and display these signals. Optionally EEG can be recorded simultaneously with the MEG using an integrated SynAmps2 (K023771) hardware system. The Orion LifeSpan™ MEG can optionally be provided with adult, child or both sized helmets. The Orion LifeSpan™ MEG is used by skilled operators or physicians trained in the acquisition and interpretation of such signals. It is used as an adjunct as part of a range of measurements performed, such as imaging and other studies, to form a more complete picture of the patient's pathology alongside a standard clinical workup.

Use of the Mag View Biomagnetometer is indicated for the patient whose physician believes that information about the magnetic fields produced by that patient's brain and information about the sources of those magnetic fields could contribute to diagnosis or therapy planning. The intended patient populations are neonates and those children with head circumferences of 50 cm or less.

The Tristan Technologies MagView Biomagnetometer (hereinafter referred to as the "MagView") utilizes superconducting signal pickup coils and Superconducting Quantum Interference Devices (SQUIDs) to detect and amplify magnetic fields produced by electrical activity in brain. The MagView consists of a sensor unit, an electronics subsystem for preliminary amplification, filtering, and analog to digital conversion of the signals from each SOUID, an electronics rack containing power supplies to power the electronics subsystem, a computer to control the operation of the electronic subsystem and the SQUIDs and to acquire and store the signal values collected by the system.

Use of the Artemis 123 Biomagnetometer is indicated for the patient whose physician believes that information about the magnetic fields produced by that patient's brain and information about the location of the sources of those magnetic fields could contribute to diagnosis or therapy planning.

The Tristan Technologies Artemis 123 Biomagnetometer (hereinafter referred to as the "Artemis 123") utilizes superconducting signal pickup coils and Superconducting Quantum Interference Devices (SQUIDs) to detect and amplify magnetic fields produced by electrical activity in brain. The Artemis 123 consists of a sensor unit, an electronics subsystem for preliminary amplification, filtering, and analog to digital conversion of the signals from each SQUID, an electronics rack containing power supplies to power the electronics subsystem, a computer to control the operation of the electronic subsystem and the SQUIDs and to acquire and store the signal values collected by the system, and a patient table which accommodates and facilitates the optimal positioning of the head of a human being adjacent to the sensor unit.

Use of the Magnes 2500 WH is indicated for the patient whose physician believes that information about the magnetic fields produced by that patient's brain and information about the location of the sources of those magnetic fields could contribute to diagnosis or therapy planning.

The Magnes 2500 WH biomagnetometer (hereafter "Magnes 2500 WH") comprises a magnetic sensor for detecting and measuring the magnetic fields produced by the human brain, along with the auxiliary equipment required to perform the measurements in a conventional medical facility environment and to display the results of the measurements to physicians in a variety of ways. The sensor utilizes an array of superconducting magnetic field pickup coils arranged in such a manner as to sense the magnetic fields over the portion of the skull enclosing the brain. For each such coil, a superconducting quantum interference device (SQUID) is used to detect the current induced in that coil by the brain magnetic field and produce a voltage proportional to the magnetic flux change. Conventional electronic and computer circuitry is used to amplify, filter, digitize, store and display the result of the measurement. The sensor includes an insulated reservoir of liquid helium as a refrigerant for cooling the superconducting components - pickup coils, SQUIDs, and interconnecting leads - to temperatures below their superconducting transition temperature. Heat is conducted from these superconducting elements along thermally conductive pathways into the helium reservoir. Provided as part of the Magnes 2500 WH biomagnetometer are the following ancillary items: Magnetically shielded room, comprised primarily of nickel-rich alloy and aluminum sheeting, to provide shielding from environmental sources of magnetic or ff noise. Manually operated non-magnetic gantry to place the sensor over the head of the patient in either a seated or supine position. Non-magnetic patient table with hydraulic elevation, to support the patient securely in either seated or supine position. Non-magnetic patient monitoring and communication devices, including video monitor, intercom, and head motion detector. Head shape and head position measurement system, to provide head shape and location relative to the sensor for data modeling and display. Computer workstation, operator console, and software to control system operation, data acquisition and storage, and data analysis and display. Sensory stimulus systems, to provide stimulation of the patient's somatosensory, auditory, y sumulus systems, to pro for magnetic measurement of evoked response.

The Neuromag-122 system is intended for use as a magneto encephalographic (MEG) device which non-invasively detects and displays biomagnetic signals produced by electrically active nerve tissue in the brain. When interpreted by a trained clinician, the data enhances the diagnostic capability by providing useful information about the location relative to brain anatomy of active nerve tissue responsible for critical brain functions.

This device integrates 122 SQUID planar gradiometers with medical super-computers and data intracelly long in order to measure the differences in the magnetic signals generated by the intracellular dendritic currents. These detectors are positioned in a helmet shaped array which gives the user the ability to record the electrical activity of the entire surface of the brain simultaneously without having to move the position of the probe.