R16M-D Diagnostic Portable Middle Ear Analyzer
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DIAGNOSTIC PORTABLE MIDDLE EAR ANALYZER PRODUCT SPECIFICATIONS GENERAL SPECIFICATIONS OPERATING ENVIRONMENT • L x W x H: 180x135x41 mm • Net weight: 570 g. • Body material: self-extinguishing ABS UL 94 V0 • Tympanometry, Reflexes, Decay with non acoustic monitor, nr.1 Quick Test with editable protocols, ETF for intact membrane and patulous ET,High Frequency Tympanometry • 7” TFT Resistive touch screen display • 800 by 480 resolution at 133 pixels per inch (ppi) 262K colors USER INTERFACE • Intuitive icon system • Internal patient database • 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 Hz for Admittance (Y) curve tympanometry • 1000 Hz for Admittance (Y) curve tympanometry with added Susceptance (B) and Conductance (G) curves. • The probe is supplied in handheld mode • Data transfer to PC with Resonance Management Data Suite installed • Dedicated report template • 226 Hz: 85dB SPL ± 2dB • 1000 Hz: 75dB SPL ± 2dB • Frequency Accuracy: ± 0,5% • Harmonic Distortion (THD): Less then 1% ADMITTANCE MEASUREMENTS • Nr.1 USB host type A (pen drive connection for software upgrade) • Nr.1 mini USB slave • Compliance range at 226Hz: 0,05 up to 7ml • Sensitivity scale: Auto Scales to appropriate range, available scale at 226Hz 1, 2, 5 and 7ml • 1000 Hz: 0 to +25 mmho • Sensitivity scale: Auto Scales to appropriate range, available scales 5, 10, 15, 20, 25 mmho WINDOWS® COMPATIBLE SOFTWARE • Resonance MDS Management Data Suite MAIN SYSTEM COMPONENTS • Operative system: Microsoft® Windows® Embedded Compact • CPU: TEGRA® 2 dual core @ 1Ghz POWER POWER SUPPLY • Built-in 3,6V/3,1 Ah rechargeable lithium-ion battery • External Medical power supply/charger: Input 100-240Vac / 0,3A - 50/60Hz; Output +5Vdc / 2A CONSUMPTION (WITH RECHARGEABLE BATTERY) • Up to 2 hours of continuous testing. • Charge time with external medical power supply: up to 80% in 2 hours • Control: Automatic • Range: two selections available: +100/-200 daPa or +200/-400 daPa • Pressure accuracy: ±10 daPa or ±10% • Sweep rate: automatic adaptive speed control or fast (200 daPa/sec) • Indicator: Measured value is displayed • Safety limitations: -750 up to +550 daPa EUSTACHIAN TUBE FUNCTION • ETF test for use with intact eardrums and patulous ET ACOUSTIC REFLEX TESTS • Reflex test method: Threshold and Fixed level • Stimulus duration: 0,5 or 1 sec. • User selectable protocols for all test methods • Ipsi or Contralateral stimulation for all reflex test • Automated peak search functions available for Quick Test • Reflex Decay: Manual • Stimulus duration: 10 or 20 sec. Please contact Resonance should you have any questions: support@resonance-audiology.com FREQUENCIES AND INTENSITY RANGES • Ipsilateral: - Pure tone level range (dBHL) from 50 to 100 • Frequency: 500, 1000, 2000, 4000 Hz • Accuracy: ±1% • Harmonic distortion (THD): less than 3% • Contralateral: - Pure tone level range (dBHL) from 50 to 115 • Frequency: 500, 1000, 2000, 4000 • Accuracy: ±1% • Calibration accuracy ±3 dB • Level steps: 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 marks. 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 edition, Class II Type BF • EMC: IEC 60601-1-2 • Impedance: IEC 60645-5 and ANSI S 3.39 STANDARD ACCESSORIES • Probe HF • Insert for Contra • Kit of assorted ear tips; size from 6 mm up to 15 mm • Calibration cavity • Resonance® MDS Software • Medical Power supply (100Vac – 240Vac) • Carrying bag • Charging Cradle • Pen Drive (with Multilingual Quick user’s handbook) • Touch screen pen OPTIONALS • Headband with DD45 for Contra • Insert phones for Contra • External USB Keyboard • USB Videotoscope • Wallmount kit The information, pictures and specifications found in this datasheet are intended as a general guideline for customers seeking information about supplies for Resonance equipment. Resonance makes no warranty, nor assumes any legal liability or responsibility for the accuracy, typing errors