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Brand Name or Equal Worksheet ( Salient Characteristics ) Brand Name Item: Natus Embla NDx Amplifier System Essential/significant physical, functional, or performance characteristics. The Natus Embla ... Brand Name or Equal Worksheet ( Salient Characteristics ) Brand Name Item: Natus Embla NDx Amplifier System Essential/significant physical, functional, or performance characteristics. The Natus Embla NDX system can provide 64 AC and 16 DC channels for advanced polysomnographic sleep studies. The system can support and integrate our current home sleep studies. The NeuroWorks/SleepWorks software supporting our current Natus home sleep study equipment. Supplies such as respiratory effort belts can be shared between the NDX amplifier and home sleep studies. Efficient, Reliable, Safety and Healthy Compatibility Compatible software and some leads with our current Natus MPR units Dimensions Base Unit - 29 x 26.5 x 5cm (11.4 x 10.4 x 2 in) Headbox - 19 x 11.4 x 3.2 cm (7.5 x 4.5 x 1.25 in) Weight Base Unit - 2300 g (5.1 lb) Headbox - 460 g (1 lb) Industry Standard Conforms. Natus and incorporated sleep study equipment (i.e. Sandman) are part of the industry standard for in-lab full polysomnography. Purpose Provide Veterans with full polysomnography to improve the diagnosis and intervention for sleep disorders Integrate current home sleep testing equipment with polysomnography capacity to provide a more comprehensive sleep care system Maximize previous training and provider/staff experience to expedite the effective utilization of new systems. Governing Body or Organization International Electrotechnical Commission Applicable model/make/catalog number: Natus Embla NDx Amplifier Manufacturer name Natus Brand Name Item: Natus Ambulatory Amplifier/TrexHD Essential/significant physical, functional, or performance characteristics. The Natus Ambulatory Amplifier is small, lightweight sleep study equipment able to provide extended leads compared to the standard home sleep study. In total the ambulatory amplifier can provide up to 24 AC leads and 4 DC leads. Device operates off two AA batteries. Internal recording which can be combined with NeuroWorks/Sleepworks. Efficient, Reliable, Safety and Healthy Compatibility Compatible with NeuroWorks/SleepWorks which can integrate the home sleep testing and in-lab sleep testing systems Dimensions 3.94 x 6.1 x 0.98 (10 cm x 15.5 cm x 2.5 cm) Weight 0.56 lb (255 g) Industry Standard Conforms to the industry standards for level II sleep testing. Purpose Provide extended lead home sleep testing with special attention to non-invasive carbon dioxide measure Integrate information with other sleep testing systems Governing Body or Organization International Electrotechnical Commission Applicable model/make/catalog number: Natus Ambulatory Amplifier/TrexHD - AMB-AMP-PP Manufacturer name Natus Brand Name Item: Natus Embletta MPR PG Sleep System Essential/significant physical, functional, or performance characteristics. The Natus Embletta MPR PG sleep study is a home sleep testing recording device designed to provide easy access to 12 channels. Unusual for home sleep testing equipment, the Embletta MPR PG specifically allows multiple effort leads and the combination of nasal pressure with thermistor for airflow. Devices can be programmed for schedule recording to simplify distribution and return of the units in an outpatient practice. Efficient, Reliable, Safety and Healthy We have had significant experience at the VAPAHCS with the Natus Embletta MPR units. The units have proven to be efficient and reliable. Compatibility Embletta MPR PG units are compatible with current home sleep testing equipment and protocols. Dimensions 4.2 x 3.1 x 0.75 (107 mm x 79 mm x 19 mm) Weight 5.4 oz (153 g) Industry Standard Complies with the industry standards. Device excels over most home devices in offering the combination of both thermistor and nasal pressure airflow which follows guidelines for respiratory event scoring. Purpose Expand home sleep testing opportunities for Veterans Integrate additional equipment with previous systems, training and expertise Continue to provide Veterans with high quality testing Applicable model/make/catalog number: Embletta MPR PG Manufacturer name Natus Brand Name Item: Natus Xltek Trex HD with Video Essential/significant physical, functional, or performance characteristics. The Natus Xltek Trex HD with Video is a full channel, small lightweight system that can provide level II sleep recording including HD. Internal recording so no need to have a computer attached. 24 AC leads and 4 DC leads. Operates off AA batteries. Efficient, Reliable, Safety and Healthy- The VAPAHCS has significant experience with Natus products including multiple generations of home sleep testing. Compatibility Through SleepWorks/Neuroworks, the Trex HD system can be integrated with the current VAPAHCS home sleep testing equipment Dimensions 3.94 x 6.1 x 0.98 (10 cm x 15.5 cm x 2.5 cm) Weight 0.56 lb (255 g) Industry Standard Conforms to the industry standards for level II sleep testing. Purpose Permit full unattended polysomnography (level II) testing for Palo Alto based inpatients Integrate with other sleep systems including current home sleep testing equipment Data security no dependent on lap tap or computer during recording Governing Body or Organization The U.S. Food and Drug Administration (FDA) develops and administers regulations under authority granted by laws passed by Congress that apply to food, drugs, cosmetics, biologics, radiation-emitting electronic products, and medical devices. Applicable model/make/catalog number: Xltex Trex HD with Video - 010753 Manufacturer name Natus Brand Name Item: NeuroWorks/SleepWorks Software Essential/significant physical, functional, or performance characteristics. NeuroWorks/Sleepworks is a flexible software designed for the review, analysis and reporting of sleep studies. Sleep reporting templates use Microsoft Word to summarize scoring/analysis. Microsoft SQL-based SleepWorks database allows simplifies management of integrated sleep testing center. Efficient, Reliable, Safety and Healthy- NeuroWorks/SleepWorks is an integration of multiple previous software designs to maximize the efficiency and user interface. Compatibility SleepWorks/Neuroworks will allow the integration of home sleep testing and more advanced testing modalities. Dimensions N/A Weight N/A Industry Standard Conforms to the industry standards. Incorporates many previous sleep study software that were considered the industry standards (i.e. REMbrandt and Sandman) Purpose Updated software to improve management capability, scoring efficiency and reporting Updated software required to coordinate different types of testing to improve management Data server license required to provide data storage on the VA server location to ensure information security Governing Body or Organization The U.S. Food and Drug Administration (FDA) develops and administers regulations under authority granted by laws passed by Congress that apply to food, drugs, cosmetics, biologics, radiation-emitting electronic products, and medical devices. Applicable model/make/catalog number: NeuroWorks/Sleepworks Software Manufacturer name Natus