R27A 2 Channel Tone and Speech Testing Diagnostic Audiomter
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2 CHANNEL TONE AND SPEECH TESTING DIAGNOSTIC AUDIOMETER PRODUCT SPECIFICATIONS DIMENSIONS AND WEIGHT • L x W x H: 370x290x180 mm • Net weight: 3.5 kg • Body material: Bayblend® self-extinguishing TEST TYPES • Pure Tone test, Autothreshold, ABLB, Speech Test, Stenger, GAP, DLF (Difference Limen for Frequency) AUDIOMETRY OPERATING SPECIFICATIONS 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 • Audiometer: to IEC 60645-1; IEC 60645-2 and ANSI S3.6, Type 2A • Frequency < 0,5% • Distortion < 1% • Attenuator linearity 1dB per 5dB step, max 3dB whole range • Range stimuli level -10 up to 120 dB HL USER INTERFACE • 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 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 • Pure tone: sine wave 125 to 8KHz signal (to 12,5KHz for HDA280 phones) • 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 • External signal • External mike • Speech material recorded on SD card • On/Off rise – fall time: 40msec OUTPUT TRANSDUCERS • ACR, ACL: 10 ohm DD45 matched pair earphone, (alternatively HDA280 Sennheiser, Insert earphones) • BC: B71-W Radioear; B81 (optional) • INSERT: Button receiver (optional) • Free field output: 600 ohm impedance • Operator headset: with boom microphone (optional) STIMULUS PRESENTATION MODALITY • Presentation: Normal, Reverse, Extended (present tone for 1 second from 20dB below the maximum level) • Modality: Continuous, Pulsed (rate 0,5; 1 and 2 Hz) Alternated (ABLB - 0,5, 1 and 2 Hz) QUALITY SYSTEM Manufactured, designed, developed and marketed under an ISO 13485, ISO 9001 certified quality system. Medical CE mark and FDA approval. STANDARD ACCESSORIES • DD45 or HDA280 headset for audiometry testing • B71W bone conductor • Patient microphone (talk back) • Internal speaker as monitor use • Built-in talk forward microphone • Patient response pushbutton • Built-in fast thermal printer • 1 roll of thermal paper • Power supply cable (110 – 220V) • Device dust cover • Multilingual Quick User’s Handbook • Pen-drive • SD-card with Multilanguage speech material • Resonance® MDS software with NoAH® module included (demo version) OPTIONALS • USB external keyboard • Goose-neck microphone • Insert-Transducer (for bone conductor masking) • TDH39 headset • Pediatric Headset (AC or BC) • ADC Audiocups Noise reducing headset enclosures • Various Insert earphones models • B81 High Output Bone Conductor • Carrying bag • MDS software licence • Quick-SIN test licence • Silent cabin cables • Free field loudspeaker • Operator headset with microphone and speaker (talk over and monitor) • Additional patient response pushbutton 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 information in this datasheet was correct to the best of our knowle