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R17A-AC_W Portable Audiometer


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R17A-AC_W Portable Audiometer - 1

SCREENING PORTABLE TOUCH SCREEN AUDIOMETER PRODUCT SPECIFICATIONS GENERAL SPECIFICATIONS QUALITY SYSTEM OPERATING ENVIRONMENT Manufactured, designed, developed and marketed under an ISO 13485, ISO 9001 certified quality system. Medical CE marks and FDA approval. • L x W x H: 180x135x41 mm • Net weight: 450 g. • Body material: self-extinguishing ABS TEST TYPES • Pure Tone test, Speech Test (performed with on-board recorded speech material), Resonance Play Audiometry (optional) • 7” TFT Resistive touch screen display • 800 by 480 resolution at 133 pixels per inch (ppi) 262K colors USER INTERFACE • Intuitive icon system • Data transfer to PC with Resonance Management Data Suite installed DATA TRANSFER TO PC • Bluetooth 2.1 • Nr.1 USB host type A (pen drive connection for software upgrade) • Nr.1 mini USB slave (for patient response connection) WINDOWS® COMPATIBLE SOFTWARE • Resonance MDS Management Data Suite MAIN SYSTEM COMPONENTS • Operative system: Microsoft® Windows® Embedded Compact • CPU: ARM® core @ 312Mhz Low power (0,8W typ.) • 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 AUDIOMETRY OPERATING SPECIFICATIONS RANGE • Frequency < 0,5% • Distortion < 1% • Crosstalk >70dB • Attenuator linearity 1dB per 5dB step, max 3dB whole range • Range stimuli level -10 up to 110 dB HL • Pure tone: sine wave 125 to 8Khz signal • Warble: +/- 5% frequency sine wave modulated, modulation: sine wave 5 Hz • Narrow band noise: 24dB/oct filtered noise • Speech noise: 1khz 12dB/oct filtered noise • White noise • Speech material recorded on internal SD-card • On/Off rise – fall time: 40msec 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 • Audiometer: IEC 60645-1and ANSI S3.6: Type 4 (R17A-AC) IEC 60645-2 (only for the functions regarding the speech test; the device is not an A or B model) STANDARD ACCESSORIES • DD45 headphones • Built in talk over microphone for patient communication • Multilingual Quick user’s handbook • Resonance® MDS software • Medical Power supply (100Vac – 240Vac) • Carrying bag • Charging Cradle • Pen Drive (with Multilingual Quick user’s handbook) • Touch screen pen OUTPUT TRANSDUCERS • ACR, ACL: 10 ohm DD45 matched pair earphone (alternatively HDA280, IP30, ER3A/5A) STIMULUS PRESENTATION MODALITY • Presentation: Normal • Modality: Steady, Pulsed (rate 2 Hz) • dB step variation: 1dB, 2dB, 5dB. 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 3 hours of testing working on speech test modality. • Charge time with external medical power supply: up to 80% in 2 hours Please contact Resonance should you have any questions: OPTIONALS • External USB Keyboard • EAR3-A/5C, IP30 Insert headphones • Pediatric Headset • RE-Play Play Audiometry for childrens • VTMR Audiometry test for adults • Wallmount kit • Patient response pushbutton • Telemonitoring • Web service data transfer 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 or mistakes, correctness or completen

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