Newborn Hearing Screening System Product Specifications Intended Use AurixTM Newborn Hearing Screening System is intended to aid in detecting hearing loss in newborns and infants from 34 weeks gestational age to 6 months by TM screening with automated auditory brainstem response. Aurix is a prescription device with labelling, instructions and user operations designed for trained personnel. System Summary Main Hardware Components: Computer Interface Portable laptop computer with Windows 7 and Aurix software or 8”/ 10” Tablet computer with Windows 8 and Aurix software. See configurations below Link Wireless interface module (#11001) Amplifier 3 tabs that check the electrodes and clips (#11003) electrode leads 16” (40cm) cable with clips (#100001) AEP Transducers ER-3A insert earphones with 59” (150 cm) cable (#ER3-AAUX) Sound Stimulator circumaural earphones with 59” (150) cm cable (#11002) AEP Transducers Option 1: Sound Stimulator Circumaural earphones specially designed to fit infants. Builtin microphone detects a loose or improper fit. Use with disposable EarDomes™ that are anthropometrically designed for newborns. Option2: ER3 Insert Earphone Set Paired and factory-calibrated set with cable and connector. Use the immittance tip adapter with your choice of disposable OAE Ear Tips Transport & Storage Environmental conditions for transport and storage: Ambient temperature of -40C to +70C. Relative humidity of 10% to 100%. Atmospheric pressure range of 500 hPa to 1060 hPa. Disposables / Consumables: Electrodes Vivosonic tab electrodes (#100001) Ear tips GRS-VIVO 94A TM EarDomes Aurix-ED / EL non-latex (#100004) Warranty One year warranty on most new parts and labor (excluding mishandling or misuse). Battery packs – 120 days. Output from Software (labels): Customizable labels, file export Quality System Meets the requirements of ISO 13485, FDA 21 CFR Part 820, Medical Devices Directive 93/42/EEC (CE marking approval). . ABR Specifications Stimulus Stimulus type: Stimulus rate: Stimulus intensity: Frequency characteristics of the modulation and the effective radiated power of transmission: Amplification Amplifier filters: Gain: Easy to use, intuitive interface; Full color Screen or Graphics; Fully compatible with OZ Systems and HiTrack databases; XML export allows for database conversion to a number of Popular formats including excel and text Alternating click 37.7 stimulations per second. Selectable between 30 and 35 dB nHL. Modulation Type: IQ Modulation Frequency Characteristic, where center frequency F0=2F1F2: Average delta F1 Modulation = 165 kHz (+10/-25 kHz) Maximum delta F2 Modulation = 125 kHz Effective Radiated Power: +1 dBm ( 3 dB) 30 10 Hz to 3 kHz 300 Hz Slope: 12 dB/octave 10 x 103 Hardware Specifications Computer Dual-core laptop with built-in Bluetooth adapter, minimum 1 USB port, 15”, 1024x768 resolution; or equivalent. Optional: touchscreen, tablet Link Sampling rate: A/D & D/A resolution: Built-in: Patient isolation: RF transmission: Dimensions: Weight: Batteries: Amplifier Nominal gain: Frequency band: Input impedance: Noise level: Common mode rejection ratio: Electrode Leads 3 leads: 3 clips: Regulatory Compliance Brazil: ANVISA, INMETRO, ANATEL. Canada: Health Canada Medical Device Licence 67609. ETL Listed 3087966. Industry Canada IC 6273A-V50. China: CFDA European Union: CE Registration DE/CA09/0170/1207 to 1212, ETSI EN 300 328 V1.6.1 (2004-07). Japan: Ministry of Health, Labour and Welfare. Korea KFDA, KCC Mexico: COFEPRIS United States: FDA 510(k) K080060. ETL Listed 3087966. FCC Part 15, FCC ID TVZ-V50. Other countries: Please enquire. Configurations All configurations include: Aurix Laptop: VivoLink, Amplifier, battery pack charging kit, carrying case, starter kit of disposables and consumables, Aurix User’s Manual (PDF), Aurix Quick Reference, Dymo Writer (Printer) Option A: Laptop with Windows 7, Aurix software and Sound Stimulator Option B: Laptop with Windows 7, Aurix software and ER3A Insert Earphones Aurix tablet: Option C: 8” or 10” Tablet computer with Windows 8, Aurix software and ER3-A Insert Earphones 38,400 samples per second (sps) 24 bit power switch and LCD Radio-frequency, spread-spectrum wireless hopping, 2,402 to 2,480 MHz, emitted power <1.02 mW, connection range 30 feet (10 meters) L 7.1” (18cm) x W 3.6” (9.1cm) x H 1.2” (3.2cm) 0.8 lb (363g) with battery pack Vivosonic rechargeable battery pack 1,000 30-3000 Hz 1.5 MΩ at 60Hz 8 nV/root (Hz) at 100 Hz >120 dB at 60 & 50 Hz (>135 dB typical) 16” (40cm) cable with clips (#100001) labeled with location at which the electrodes are to be applied on you patient. Alligator clips North America: 1.877.255.7685 Intl: 1.416.231.9997 Fax: 416.231.2289 E-mail: [email protected] 120-5525 Eglinton Ave. W. Toronto, ON M9C 5K5 Integrity™, SOAP™, Amplitrode™, VivoLink™ and Aurix™ are all trademarks of Vivosonic Inc. U.S. Patent Nos. 6,778,955, 7,206,625, 7,286,983, 7,548,774 . Other patents pending in the U.S. and other countries. FDA, FCC Cleared, Health Canada Licensed, CE Marked. Document No. D-11418-ENG Rev1, 3-December-2013.