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THIS DEVICE IS INTENDED FOR USE IN LONG-TERM RECORDING OF VOLT AGES PRODUCED BY THE BRAIN AND MEASURED ON THE SCALP (EEG) FOR SUBSEQUENT DIAGNOSTIC REVIEW WITH I II DIGITAL WORK - STATION SUPPLIED BY THE MANUFACTURER (TELEFACTOR BEEKEEPER) OR A DIGITAL WORLE DEVICE. AN INTEGRATED PULSE OXIMETER PROVIDES SUPPLEMENTAL DIAGNOSTIC DATA IN THE FORM OF BLOOD OXYGEN SATURATION (SPO2 PERCENT).

H2O receives signals from an EEG Amplifier, formats, and transmits them via a cable to a data collection and review workstation. The device can function either as a self-contained, battery-powered recorder or as an externally powered cable telemetry device. The "tethered option" which is the subject of this application is identical to the original H2O in every respect except that the battery pack is replaced with an isolating dc to dc converter power supply and a 115 kbaud optical isolator link for data communication. The function of this communication link is to replace the rotating wearable disk. Both the dc to dc converter and the optical isolator maintain a 4000 volt insulation barrier between the patient all external wire and cables. Power is supplied in the form of Svolts dc at one half ampere maximum current. This power is most commonly supplied through the keyboard adapter of a host computer, but when long communication distances are required may be supplied by a small local medical-grade 5 volt supply. The dc to dc converter operates at about 25 kHz and is of the resonant variety so that no measurable interference is produced by its switching action. To provide an added sensor modality useful in sleep recordings, the H2O incorporates a NONIN pulse oximeter board (NONIN OEM2 Pulse Oximeter Module), with a DB9 Female connector for one of the compatible NONIN finger probes. This option is retained in the tethered mode.

The DEEG-LITE-OXY is intended for use in long-term recording of voltages produced by the brain and measured on the scalp (EEG) for subsequent diagnostic review with a digital workstation supplied by the manufacturer (Telefactor Beekeeper) or similar compatible device. An integrated pulse oximeter provides supplemental diagnostic data in the form of blood oxygen saturation (SpO2 percent).

The DEEG-LITE-OXY system consists of (a) a laptop computer with liquid crystal display, (b) a MicroCoder which consists of State) Signa components such as: a mgil resolution Analog to Digital converter, a DSP (Digital Signal processor a safe low voltage includes supply and (d) a wearable, 32 channel EEG amplifier/recorder, and (e) an internal pulse ossimeter module supplied by Neilcor(model Mr 205). The DDLG De De oximeter module, all of the foregoing power supply. With the exception of the pulse oximeter modules income DEEC I ITE power supply. With the excopiton of unded in the predicate device DEEG-LITE.

THIS DEVICE IS INTENDED FOR USE IN LONG-TERN RECORDING OF VOLTAGES PRODUCED BY THE BRAIN AND MEASURED ON THE SCALP (EEG) FOR SUBSEQUENT DIAGNOSTIC REVIEW WITH A DIGITAL WORK-STATION SUPPLIED BY THE MANUFACTURER (TELEFACTOR BEEKEEPER) OR SIMILAR COMPATIBLE DEVICE. AN INTEGRATED PULSE OXIMETER PROVIDES SUPPLEMENTAL DIAGNOSTIC DATA IN THE FORM OF BLOOD OXYGEN SATURATION (SpO2 percent).

The H2O system is battery powered, wearable, 32 channel EEG amplifies/recorder. The H2O system operates on a pack of eight Alkaline batteries for twelve hours or a pack of two lithium batteries for 24 hours. Unlike DEEG-LITE, the H2O recorder never operates from mains power, but only from batteries. Like DEEG-LITE, a binary, optically isolated output data stream is utilized by a notebook or desktop computer for initial setup. Unlike DEEG-LITE, all data recording in H2O is performed internally in the wearable device in a Flash-RAM for short recordings, or on an internal rotating disk for long recordings. The DEEG-LITE utilizes DSPs (Digital Signal Processors) for data manipulation and preparation. It uses a Intel-486 or Pentium processor in a notebook computer for data recording and display. H2O uses a single internal INTEL 186 processor for data manipulation and recording and an external notebook or desktop computer only for initial setup and electrode application to verify good EEG waveform at the beginning of the data recording session. To provide an added sensor modality useful in sleep recordings, the H2O incorporates a NONIN pulse oximeter board (NONIN OEM2 Pulse Oximeter Module), with a DB9 Female connector for one of the compatible NONIN finger probes.

this device is intended for use in rong-term digital recording of voltages produced by the brain and measured on the scalp (EEG) for subsequent diagnostic review with a digital workstation supplied by the manufacturer (Telefactor Beekeeper) or similar compatible device.

The DEEG-LITE system consists of (a) a laptop computer with liquid crystal display, (b) a MicroCoder which consists on as: a high resolution Analog to Digital converter, a DSP (Digital Signal Processor) and programmable logic devices, (c) a power supply and (d) a weatable, 32 chamel EEG amplifier/recorder identical to that used with the current Telefactor BEEHIVE system (510(k) #884937). The DEEG-LITE system operates on a safe low voltage power supply, as does the BEEHIVE system which is based on a standard desk-top personal computer.