Search Results

The Falcon HST is an EEG and respiratory signal recorder. The device is intended for use by adult patients in the home or clinical environment, under the direction of a qualified healthcare practitioner, to aid in the diagnosis of sleep disorders.

The Falcon HST comprises hardware and software which provide separate parameters for recording, review, and analysis of collected and stored physiological parameters, including EEG, EOG, ECG and respiratory signals, which are then used as an aid in the diagnosis of respiratory and/or cardiac related sleep disorders by qualified physicians. The Falcon system consists of the main unit and the charging cradle. The main unit is a small device that is worn on the patient's chest over clothing. It is equipped with a touch-screen LCD and contains various channel inputs such as for the inductive plethysmography bands, and electrodes. The Falcon charging cradle is used to charge the device, as well as provide a USB interface for transferring study data to the PC.

The Somfit system is a non-invasive prescription device for home use with patients suspected to have sleep-related breathing disorders. The Somfit is a diagnostic aid for the detection of sleep-related breathing disorders, sleep staging (REM, N1, N2, N3, Wake), and snoring level. The Somfit system acquires electrical data from three frontal electrodes, triaxial accelerometer data, acoustic and plethysmographic data. The Somfit calculates and reports to clinicians EEG/EOG channels, Sleep Stages, SpO2, Peripheral Arterial Tonometry (PAT) signal, pulse rate, and snoring level. The Somfit calculates and reports to clinicians derived parameters such as PAT-derived Apnea Hypopnea Index, Obstructive Desaturation Index; and hypnogram-derived indices such as time in each sleep stage. Somfit data is not intended to be used as the sole or primary basis for diagnosing any sleep-related breathing disorder, prescribing treatment, or determining whether additional diagnostic assessment is warranted. The Somfit is not intended for use as life support equipment, for example vital signs monitoring in intensive care unit. The Somfit is a prescription device indicated for adult patients aged 21 years and over.

The Somfit is a home-based sleep monitoring device which records signals from the patient's forehead and surrounding environment. Somfit is a wearable, low voltage, battery operated device which is attached to subject forehead via a self-adhesive and disposable skin electrode patch. The electrodes are placed on the anterior Prefrontal cortex (PFC) at the Fp1 and Fp2 positions according to the 10/20 EEG system. The device allows for recording of two frontal EEG signals, pulse rate, SPO2, Peripheral Arterial Tonometry (PAT), PPG, motion, and snore. Somfit uses a mobile phone application to acquire data wirelessly via Bluetooth LE technology, then transfer into a secure cloud, for management, storage and postprocessing. The software reports measured parameters in a format compatible with AASM guidelines, including sleep time, pAHI and conventional graphical displays such as a hypnogram.

The Okti System is intended for use in the recording, displaying, analysis, printing and storage of human biological parameters such as heart and muscle activity, eye movement, breathing and body movements to assist in the diagnosis of various neurological disorders. The Okti is designed for use in a hospital or other clinical environment. The Okti is only to be used under the direction of a physician.

The Okti is a physiological data acquisition device intended for conducting EEG studies. It is used in conjunction with a PC running Compumedics Profusion EEG software. Power is provided by either an internal Lithium-Ion battery or a POE 100BASE-TX network connection. Physically, the Okti comprises a base unit housing the battery and digital electronic circuits. A changeable module connects to the base unit and houses the analogue circuity and electrode connectors providing options for 32, 64 or 128 referential, or single ended, channels primarily intended for EEG. Each module includes several differential inputs for electrode-based signals such as ECG, EMG or EOG. All these inputs are class CF for patient safety. Patient physiological data is digitised using multiple 24-bit ADCs and filtered using fixed point FIR filters implemented internally to an FPGA located in the analogue module. The data is transferred to a generalpurpose processor in the base unit over a synchronous serial link. From there the patient data may be saved to a device internal SD card or sent to a remote PC over an Ethernet or Wi-Fi LAN connection. A Bluetooth interface is also included for connection to external devices such as an oximeter. The Okti system is available in Okti32, Okti64, or Okti128. These differ only in channel number.

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.

The GRAEL SYSTEM is intended for use in the recording, displaying, analysis, printing and storage of human biological parameters such as heart and muscle activity, eye movement, breathing and body movements to assist in the diagnosis of various sleep disorders or neurological disorders. The Grael is designed for use in a hospital or other clinical environment. The Grael is only to be used under the direction of a physician.

Grael and Grael EEG are standalone units, which together with sensors and a PC running Compumedics PSG Online and Profusion PSG software for sleep studies and/or Profusion EEG for EEG studies, can record, review and analyze a number of physiological parameters, including EEG, EOG, EOG and respiratory signals. These are then used as an aid in the diagnosis of respiratory and/or neurological related sleep disorders or other neurological conditions by qualified physicians. The system is comprised of hardware and software which, depending on the model type, provides up to 60 separate parameters for recording, review and analysis.

The Somté PSG is intended for use in the recording, displaying, analysis, printing and storage of human biological parameters such as heart and muscle activity, eye movement, breathing and body movements to assist in the diagnosis of various sleep disorders or sleep related respiratory or cardiac disorders. The Somté PSG is designed for ambulatory and mobile operation and can be used in either the patient's home, the hospital or other environments, thus enabling patients to be investigated under as realistic conditions as possible. The Somté PSG is only to be used under the direction of a physician.

The Somté PSG System comprises hardware and software which provides up to 27 separate parameters for recording, review and analysis of collected and stored physiological parameters, including EEG, EOG, ECG and respiratory signals, which are then used as an aid in the diagnosis of respiratory and/or cardiac related sleep disorders by qualified physicians. The Somté PSG device consists of two components permanently connected by a cable: the Patient Input Box (PIB) and the Recorder. The Somté PSG device is powered by 2 AA Batteries - Alkaline or NiMh.

The Somté System is a multi-functional ambulatory recording device intended to be used to collect and store signals related to sleep disorders, including respiratory signals, ECG signals and limb movement signals, to aid in the diagnosis of respiratory and/or cardiac related sleep disorders. The Somté System is not intended for use as life support equipment such as vital signs monitoring in intensive care units. The Somté System is only to be used under the direction and supervision of a physician, technologist or clinician. It will not prevent or restore the interruption or loss of any physiological system.

The Compumedics Somté Patient Recording System is a multi-functional, ambulatory recording device. The Somté is used to collect and store a patient's ECG and respiratory signals, which are then used as an aid in the diagnosis of cardiac and/or respiratory related sleep disorders by qualified physicians. The system is comprised of hardware and software, which provides up to 13 separate parameters for recording, review and analysis. The data are acquired from a combination of electrodes, sensors and transducers. Signal types can include electrocardiogram (ECG), pressure, airflow, snore, respiratory effort, body position, limb movement, oxygen saturation, pulse rate and pulse waveform. The electrodes and sensors used to acquire patient data are connected between the patient and the Somté System Recorder. Patient Studies are recorded using the Compumedics Somté Software which allows the user to view, print, summarise, analyse and create Patient Study reports. The Somté Patient Recording Unit has a built in Compact Flash Disk interface for storage and convenient transfer to review workstations. There is no proprietary hardware required to transfer the study data.