DIAGNOSTIC MIDDLE EAR ANALYZER PRODUCT SPECIFICATIONS 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, Quick Test, Quick Screening 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” 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 Please contact Resonance should you have any questions: [email protected] TYMPANOMETRY OPERATING QUALITY SYSTEM SPECIFICATIONS PROBE TONE • 226 Hz for traditional Y-curve tympanometry • 226 Hz: 85dB SPL ± 2dB • Frequency Accuracy: ± 0,5% • Harmonic distortion: Less then 1% ADMITTANCE MEASUREMENTS • Compliance range at 226Hz: 0,05 up to 7ml • Sensitivity scale: Auto Scales to appropriate range, available scale at 226Hz 1.5, 2, 5 and 7ml • Control: Automatic • Range: from +200 up to -400 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 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 stimulation for all reflexes 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. 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% • Calibration accuracy ±3 dB • Level steps: 1, 2, 5 or 10 dB • On/Off ratio: 70 dB minimum Manufactured, designed, developed and marketed under an ISO 13485, ISO 9001 certified quality system. Medical CE marks 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 2 STANDARD ACCESSORIES • Handheld Probe 226 Hz • Probe cleaning tool kit • 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 • MDS software licence 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 Resonance makes no warranty, nor assumes any legal liability or responsibility for the accuracy, typing errors or mistakes, correctness or completeness of any information in this datasheet. The infor