CLINICAL MULTIFREQUENCY GENERAL SPECIFICATIONS DIMENSIONS AND WEIGHT • L x W x H: 370x290x180 mm • Net weight: 3.5 kg • Body material: Bayblend® self-extinguishing TEST TYPES Tympanometry, Acoustic Reflex, Reflex Decay, nr. 3 Quick Test, Acoustic Reflex Latency Test (ARLT), ETF (Intact, Perforated and Patulous), Special tests (Growht-DLI and Non acoustic), Multifrequency Tympanometry USER INTERFACE • Multilingual • Built-in fast thermal printer with paper width: 112 mm supplied as standard part • Printed on thermal printer • .pdf report create directly from the device and stored on USB Pen drive with possibility to add patient data and tests comments via the USB Keyboard (optional) • Data transfer to PC using Resonance Management Data Suite “CHILDREN” FEATURE • To help keep the child distracted while running screening “Quick Check” or “Tympanometry HF”, a series of animated images appears on the color display DATA TRANSFER TO PC • Via cable trough USB port COMMUNICATION PORT • Nr.1 USB host type A • Nr.1 USB slave type B WINDOWS® COMPATIBLE SOFTWARE • Resonance MDS Management Data Suite POWER POWER SUPPLY • Max current: 0,15A • Power consumption: 40VA ENVIRONMENTAL OPERATING ENVIRONMENT • Storage: -20° C up to +50° C • Operating: +15° C up to +35° C • Humidity: up to 90%, (non condensing) • Ambient pressure: from 700hPa up to 1060hPa TYMPANOMETRY OPERATING SPECIFICATIONS PROBE TONE • 226, 678, 800 and 1000 Hz • Measured components: Admittance (Y), Susceptance (B) and Conductance (G) • 226 Hz: 85dB SPL ± 2dB • 678, 800 and 1000 Hz: 75dB SPL ± 2dB • Frequency Accuracy: ± 0,5% • Harmonic distortion: Less then 1% ADMITTANCE MEASUREMENTS • Compliance range at 226Hz: 0,05 up to 7ml • 678, 800 and 1000 Hz: 0 to +25 mmho • Sensitivity scale: Autoscale to appropriate range; available scale at 226Hz: 1.5, 2, 5ml or 7ml • Sensitivity scale HF: Autoscale to appropriate range, available scales at 678, 800 and 1000Hz: 5, 10, 15, 20, 25 mmho • Control: Automatic and Manual • Range: from +400 up to -600 daPa adjustable in 50 daPa steps • Pressure accuracy: ±10 daPa or ±10% • Sweep rate: 50, 100, 200,300 daPa/sec and automatic • Indicator: Measured value is displayed • Safety limitations: -800 up to +600 daPa EUSTACHIAN TUBE FUNCTION • ETF test for use with both intact and perforated eardrums • Available also test for patulous tympanic membrane ACOUSTIC REFLEX TESTS • Reflex test method: Threshold , Automatic, Manual • Stimulus duration: 0,5 , 1 or 2 sec. • User selectable protocols for all test methods • Ipsi or Contralateral stimulation for all reflex test • Automated peak search functions available for all test methods • Manual Reflex: Pump manual control of all stimuli • Reflex Decay: Threshold , Automatic, Manual • Stimulus duration: 10 or 20 sec. • ARLT: Threshold , Automatic, Manual • Stimulus duration: 1 sec. fixed • Non Acoustic: 10/20 sec. FREQUENCIES AND INTENSITY RANGES • Ipsilateral: - Pure tone level range (dBHL) from 50 to 110 - Noise level range (dBSPL) from 50 to 100 • Frequency: 500, 1000, 2000, 3000, 4000 Hz, BBN,HP or LP noise • Accuracy: ±1% • Harmonic distortion (THD): less than 3% Please contact Resonance should you have any questions: [email protected] • Contralateral: - Pure tone level range (dBHL) from 50 to 120 - Noise level range (dBSPL) from 50 to 115 • Frequency: 250, 500, 1000, 2000, 3000, 4000, 6000, 8000 Hz, BBN,HP or LP noise • Accuracy: ±1% • Calibration accuracy ±3 dB • Level steps: 1 , 2, 5 or 10 dB • On/Off ratio: 70 dB minimum QUALITY SYSTEM Manufactured, designed, developed and marketed under an ISO 13485, ISO 9001 certified quality system. Medical CE mark and FDA approval. COMPLIANCE/REGULATORY STANDARDS Designed, tested and manufactured to meet the European and International Standards: • MDD 93/42/EEC and update 2007/47/CEE: Class IIa (as referred to in Annex IX, rule 10 of said MDD 93/42 EEC ) • Safety: IEC 60601-1, 3rd and 2nd edition, Class 1 Type B • EMC: IEC 60601-1-2 • Impedance: IEC 60645-5/ANSI S.3.39 Type 1 STANDARD ACCESSORIES • Headband Probe 226 Hz • Headband Probe HF • Probe cleaning tool kit • DD45 for Contra • Insert for Contra • Kit of assorted ear tips; size from 6 mm up to 15 mm • Calibration cavity with probe holder • Built-in fast thermal printer • Thermal paper roll • Device dust cover • Multilingual Quick user’s handbook • Pen Drive • Resonance® MDS software with NOAH® module included (demo version) • Power supply cable (110 – 220V) • Spare fuse OPTIONALS • Kit of assorted silicone ear tips “MS” shape size from 8 mm up to 16 mm • External USB Keyboard • Carrying bag • Foot switch Resonance makes no warranty, nor assumes any legal liability or responsibility for the accuracy, typing errors or mistakes, correctness o