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The Protektor32 channel system, composed of both hardware and software, is intended to be used for intracperative neurological monitoring. The instrument uses Electroencephalogical by (EEG), Evoked Potentials (EP), Electromyography (EMG) and Transcranial Motor Evoked Potential (TcMEP ) stimulation techniques to provide the healthcare professionals with information to help assess a patient's neurological status during surgery. The TcMEP mode is intended for intraoperative diagnosis of acute dysfunction in corticospinal axonal conduction brought about by mechanical trauma (traction, shearing, lornrovin, or compression) or vascular insufficiency. The EPWorks software, an integral part of the system, is intended to allow a medical professional to manually configure stimulation and acquisition parameters and to manually create EEG, EP, EMG and TcMEP protocols according to their own requirements. The intended use for each of the software's outputs is as follows: - The EEG, EP, and EMG waveforms are intended to help the user assess a patient's . neurological status during surgery. - Simple waveform parameters (e.g., amplitude, latency), and user-defined Fast Fourier . transform (FFT) displays (compressed spectral array or CSA, density spectral array or DSA) are intended to help the user analyze the EEG and EP waveforms. This device is intended to be used by qualified medical practitioners, trained in EEG, EP and EMG who will exercise professional judgment when using the information.

The Protektor32 channel system, composed of both hardware and software.

The Olympic Brainz Monitor (OBM) is a three channel electroencephalograph (EEG) acquisition system intended to be used in a hospital environment to record, collect, display and facilitate manual marking of aEEG recordings. - . The signals acquired from P3-P4, C3-P3 and C4-P4 channels are intended for use only with neonatal patients (defined as from birth to 28 days post delivery, and corresponding to a postconceptual age of 24 to 46 weeks) to display aEEG for monitoring the state of the brain. - The signals acquired from P3-P4 channel is intended to assist in the prediction of and severity . of Hypoxic-Ischemic Encephalopathy and long-term outcome in full term neonates (postconceptual age of 37-46 weeks) who have suffered a hypoxic-ischemic event. The Olympic Brainz Monitor does not provide any diagnostic conclusion about the patient's condition.

a three channel electroencephalograph (EEG) acquisition system intended to be used in a hospital environment to record, collect, display and facilitate manual marking of aEEG recordings.

The Neuroworks is EEG software that displays physiological signals. The intended user of this product is a qualified medical practitioner trained in Electroencephalography. This device is intended to be used by qualified medical practitioners who will exercise professional judgment in using the information. - The Neuroworks EEG software allows acquisition, display, archive, review and analysis . of physiological signals. - The Seizure Detection component of Neuroworks is intended to mark previously . acquired sections of the adult (greater than or equal to 18 years) EEG recordings that may correspond to electrographic seizures, in order to assist qualified clinical practitioners in the assessment of EEG traces. EEG recordings should be obtained with full scalp montage according to the standard 10/20 system. - The Spike Detection component of Neuroworks is intended to mark previously acquired l sections of the adult (greater than or equal to 18 years) EEG recordings that may correspond to electrographic spikes, in order to assist qualified clinical practitioners in the assessment of EEG traces. EEG recordings should be obtained with full scalp nontage according to the standard 10/20 system. - The aEEG functionality included in Neuroworks is intended to monitor the state of the 포 brain. The automated event marking function of Neuroworks is not applicable to aFEG. - Neuroworks also includes the display of a quantitative EEG plot, Compressed Spectrum 1 Array (CSA), which is intended to help the user to monitor and analyze the EEG waveform. The automated event marking function of Neuroworks is not applicalle to CSA. This device does not provide any diagnostic conclusion about the patient's condition to the user.

The Neuroworks is EEG software that displays physiological signals.

The ENoG Protocol is a feature of the Navigator Pro with AEP Software Evoked Response System and is intended to record evoked responses upon presentation of sensory stimuli to the facial nerve. The product is indicated for use as an assessment tool to supplement the case history information, physical examination, imaging studies, and/or other sensory evaluations conducted by or on the order of the physician.

The ENoG Protocol is a feature of the Navigator Pro with AEP Software Evoked Response System; a Windows® based software application for use with the Navigator Pro hardware platform for the recording of evoked responses (i.e., electrical potentials) upon the presentation of sensory stimuli. The ENoG Protocol works on the basis of a repeating stimulus-response cycle. It is a convenience feature developed for the user to quickly set up testing for Electroneuronography evaluation of the facial nerves. The protocol utilizes the existing technology of the evoked response somatosensory function of the software. The evoked response from the patient is recorded through the use stimulus electrodes positioned near the mastoid, a cathode behind the earlobe, and an anode in front of the earlobe with the forehead as the ground.

The ALGO 5 Newborn Hearing Screener is a mobile, noninvasive instrument used to screen infants for hearing loss. The screener uses AABR® technology. The screener is intended for babies between the ages of 34 weeks (gestation age) and 6 months. Babies should be well enough to be ready for discharge from the hospital, and should be asleep or in a quiet state at the time of screening.

The ALGO 5 detects the auditory brainstem response (ABR) to a series of stimulus clicks ('clicks'), which screens the entire hearing pathway from the outer ear to the brainstem. The ABR is not affected by the status of the middle ear, and evaluation of middle ear status is not required prior to ABR detection. The ALGO 5 generates soft clicks at 35 dB nHL or at 40 dB nHL ('normal hearing level' scale) which are delivered to the infant's ears through an Acoustic Transducer Assembly cable (ATA) to disposable earphones (Flexicouplers™ Disposable Earphones). Each click evokes a series of identifiable brain waves from the auditory brainstem area of the infant's brain. Sensors (Jelly Tab™ Sensors) applied to the infant's skin pick up the brain wave response and transmit the signals to the screener via the Patient Cable Attachment (PCA) and Preamplifier (Preamp) assemblies. The ALGO 5 uses advanced signal processing technology to separate the ABR from background noise and from other brain activity. The ALGO 5 uses a statistical algorithm to determine if there is a response to the stimulus, and if a response is detected, whether the response is consistent with a template of ABRs derived from normal hearing infants (automated auditory brainstem response technology, AABR).

The neoBLUE cozy phototherapy light is intended for the treatment for neonatal hyperbilirubinemia. It is designed to provide phototherapy treatment from underneath the baby. The neoBLUE cozy system must be used within a patient enclosure, such as a bassinet, an open crib, a warming table or an incubator. The neoBLUE cozy system can be used in a clinical setting or in the home.

The neoBLUE cozy system is a portable phototherapy light that delivers a narrow band of high-intensity blue light via blue light emitting diodes (LEDs) to provide treatment for neonatal hyperbilirubinemia. The neoBLUE cozy system is designed to vrovide phototherapy treatment from underneath the baby. The neoBLUE cozy system must be used within a patient enclosure, such as a bassinett, an open crib, a warming tat hlast or incubator. Blue LEDs emit light in the range of 400 -- 550 nm (peak wavelength 450-470 nm). This range corresponds to the spectral absorption of light by bilirubin, and is thus considered to be the most effective for the degradation of bilirubin. Blue LEDs do not emit significant energy in the ultraviolet (UV) region of the spectrum, so there is no concern about UV exposure to the infant. As with all phototherapy lights, protective eyeshades must be used to protect the infant's eyes from excessive light exposure. LEDs have minimal light output degradation over their lifetime with proper use. Nevertheless, the biomedical engineer can adjust the output of the LEDs using the potentiometer located behind the filter cover at the flat end of the light enclosure. The system is expected to operate at intensities above 30 uW/cm2/nm for approximately 3.000 hours. The neoBLUE cozy system consists of five components: the neoBLUE cozy light source (light), the mattress, the disposable mattress cover, the bumper accessory, and the power supply.

The ALGO® 3i Newborn Hearing Screener is a portable, noninvasive instrument used to screen infants for hearing loss. The screener uses Natus AABR® technology. The screener is intended for babies between the ages of 34 weeks (gestational age) and 6 months. Babies should be well enough to be ready for discharge from the hospital, and should be asleep or in a quiet state at the time of screening.

The ALGO® 3i Newborn Hearing Screener is a portable, noninvasive instrument used to screen infants for hearing loss. The screener uses Natus AABR® technology. The ALGO 3i Newborn Hearing Screener is a modification of the ALGO 3 Newborn Hearing Screener. The ALGO 3i and the ALGO 3 Newborn Hearing Screeners have the same intended use and use the same operating principle. The new device performs and is specified within all performance parameters of the predicate device.

The Natus® Blue Light Phototherapy Unit is a floor-stand, mobile, phototherapy light intended for the treatment of neonatal hyperbilirubinemia. The device can be used for infants in a bassinet, incubator, open bed, or radiant warmer. It emits a narrow band of blue light considered to be the most effective in the degradation of bilirubin.

The Natus Blue Light Phototherapy Unit is a floor-standing, mobile phototherapy device that delivers a narrow band of high-intensity blue light via blue light emitting diodes (LEDs) to provide treatment for neonatal hyperbilirubinemia. The device consists of a lightweight plastic light enclosure that can be tilted and adjusted both horizontally and vertically on a rollstand assembly. The light enclosure can be tilted to a maximum of approximately 40° up from horizontal (the resting position). The light enclosure height can be adjusted vertically along the rollstand post, as well as horizontally out from the rollstand post (proximity adjustment) to aid in positioning the device. A red target light can be briefly illuminated by the user, using a rocker switch on the front panel, to help position the device over the infant. The device can be used for infants in a bassinet, incubator, open bed, or radiant warmer. There are two intensity settings, high and low. The user selects the desired setting using a rocker switch on the front panel of the device. The light output is optimized to provide an average intensity of 35 uW/cm-/nm at the high setting and 15 uW/cm-/nm at the low setting at 30 cm (12 inches) distance from the baby. A diffuser panel provides a more uniform illumination pattern from the multiple LED light sources, and protects the user from viewing a single point source of light. The diffuser panel also protects the device from incidental debris or fluid exposure. Blue LEDs emit light in the range of 400 - 550 nm (peak wavelength 450-475 nm). This range corresponds to the spectral absorption of light by bilirubin. and is thus considered to be the most effective for the degradation of bilirubin. Blue LEDs do not emit significant energy in the ultraviolet (UV) region of the spectrum, so there is no concern about UV exposure to the infant. In addition, blue LEDs do not emit significant energy in the infrared (IR) region of the spectrum, so there is no concern about IR exposure and excessive warming of the infant. As with all phototherapy devices, protective eye shades should be used to protect the infant's eyes from excessive light exposure. LEDs have minimal light output degradation over their lifetime with proper use. Nevertheless, the user can adjust the output of the LEDs using two potentiometers located on the side of the light enclosure. Instructions for adjusting the output are included in the User Manual (see Appendix A). A drawing of the location of the location of the potentiometers is included in Appendix C. In normal operating conditions the device is expected to operate as specified approximately 10,000 hours at the low setting, and approximately 3,000 hours at the high setting. No pre-aging of the LEDs is required; the LEDs are 'burned in' at the factory. The Natus Blue Light device is mains-power operated. The power cord plugs into a receptacle at the power inlet at the back of the light enclosure. There are no single-use components or accessories for the Natus Blue Light Phototherapy device.

The ALGO® 3 Newborn Hearing Screener is a mobile, noninvasive instrument used to screen infants for hearing loss. The screener uses AABR® technology. The screener is intended for babies between the ages of 34 weeks (gestational age) and 6 months. Babies should be well enough to be ready for discharge from the hospital, and should be asleep or in a quiet state at the time of screening.

Like the predicate device, the ALGO 3 detects the auditory brainstem response (ABR) to a series of stimulus clicks ('clicks'), which screens the entire hearing pathway from the outer ear to the brainstem. The ABR is not affected by the status of the middle ear, and evaluation of middle ear status is not required prior to ABR detection. The ALGO 3 generates soft clicks at 35 dB nHL ('normal hearing level' scale) which are delivered to the infant's ears through an Acoustic Transducer Assembly cable (ATA) to disposable earphones (Flexicouplers™ Disposable Earphones); a 35 dB nHL stimulus will detect a 30 dB nHL hearing loss. Each click evokes a series of identifiable brain waves from the auditory brainstem area of the infant's brain. Sensors (Jelly Tab™ Sensors) applied to the infant's skin pick up the brain wave response and transmit the signals to the screener via the Patient Cable Attachment (PCA) and Preamplifier (Preamp) assemblies. The screener uses advanced signal processing technology to separate the ABR from background noise and from other brain activity. The ALGO 3 automatically compares the baby's ABR to a template of ABRs derived from normal hearing infants (automated auditory brainstem response technology), and prints a "PASS" or "REFER" result. A "PASS" result is printed if the ALGO 3 can detect, with sufficient statistical confidence, that an ABR is present and consistent with its template. A "REFER" result is printed if the ALGO 3 cannot detect an ABR response with sufficient statistical confidence or one that is consistent with the template. A built-in printer prints the result on a self-adhesive label, which can be affixed directly to the infant's medical chart. The ALGO 3 is also capable of screening using clicks at 40 dB nHL. Some newborn hearing programs (international programs, for example), and some programs prefer to set the screening threshold at 40 dB nHL rather than at 35. The incorporation of a 40 dB screening application in the ALGO 3 device makes the device more useful to more users. The ALGO 3 device is easy enough for trained volunteers and other trained non-medical personnel to use. Interpretation of screening results is not required, as the screener automatically determines if the response is consistent with a template and automatically generates a "PASS" or "REFER" result, as previously discussed. In addition, training is minimal because of the easy-to-navigate graphical user interface, HELP topics in software, and a user tutorial in the ALGO 3 software. Screening results can be tracked using the integrated ALGO DataBook® NHS Data Tracking System software. The DataBook utility retrieves and displays patient and screening data stored in ALGO 3 software. Data can be viewed on the ALGO 3's display; can be saved as an ASCII file on diskette for data management and reporting purposes; and can be exported to other databases for data management and reporting purposes. There are no user-adjustable parameters, so that each screen is performed under exactly the same conditions. Click rate, click intensity, impedance threshold, and noise rejection thresholds are all pre-programmed into the device software, and users cannot change these screening parameters. The ALGO 3 is composed of the following components, as is the Predicate Device: - Screening module, with laptop computer - Printer module, with label printer - Cable assemblies (ATA, PCA, Preamp) - Cart for transport and component storage - Screening and accessory supplies Accessories available for use with the ALGO 3 include single-use, disposable FlexiCouplers Disposable Earphones, and single-use, disposable Jelly Tab Sensors.

The Natus Breath Analyzer is intended for non-invasive, quantitative measurement of respiratory rate, end tidal carbon dioxide concentration, and end tidal carbon monoxide (corrected for background carbon monoxide) concentration in the breath. The analyzer is intended for use with neonates, children, and adults breathing spontaneously. The analyzer measures the carbon monoxide concentration in end tidal breath, as an indicator of the blood level of COHb. The level of COHb (and consequently the concentration of carbon monoxide in the end tidal breath) can be affected by endogenous sources (for example the rate of hemolysis), exogenous sources (for example, combustion engine exhaust), or in some cases both. The COHb level, elevated or normal, can be used in the diagnosis of medical conditions in which the rate of hemolysis may be relevant, and in the monitoring of patient populations affected by the rate of hemolyzer is also indicated for use in respiratory status evaluation, whenever measurements of respiratory rate and end tidal carbon dioxide concentration are desired. The analyzer is intended for use under the direction of a physician in hospitals and a variety of health care settings.

The Natus Breath Analyzer system is a point-of-care test that consists of the instrument and a single-use patient sampler. The patient sampler incorporates a flexible nasal catheter with a filter cartridge that attaches to the device. An integral adhesive strip on the catheter aids in proper placement in the nostril. The computer-controlled instrument contains two gas analysis sensors: an infra-red carbon dioxide sensor and an electrochemical carbon monoxide sensor. The signal produced by the carbon dioxide sensor is analyzed to determine the end tidal carbon dioxide concentration and the respiratory rate. The signal produced by the carbon monoxide sensor is analyzed to determine the average carbon monoxide concentration. The end tidal carbon monoxide concentration is calculated by an algorithm using carbon monoxide and carbon dioxide concentrations. During the automated test procedure the device displays appropriate prompts. The user operates the instrument by selecting menu options from the display screen. During sampling, a small volume of the patient's breath is continuously drawn into the instrument for a short time. Results are displayed and printed at the end of the test. The Natus Breath Analyzer utilizes the same respiratory gas concentration measurement technology as the predicate devices.