R37A
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2 CHANNEL TONE AND SPEECH TESTING CLINICAL AUDIOMETER PRODUCT SPECIFICATIONS DIMENSIONS AND WEIGHT • L x W x H: 370 x 290 x 180 mm • Net weight: 3.5 kg AUDIOMETRY OPERATING SPECIFICATIONS COMPLIANCE/REGULATORY STANDARDS Designed, tested and manufactured to meet the European and International Standards: Pure Tone test, Autothreshold, ABLB, Speech Test, Stenger, DLI, SISI, Bekesy, Tone Decay, MLB, Multifrequency, GAP, DLF (Difference Limen for Frequency) • Frequency range: 125 - 8000 Hz (with DD45) 125 - 12500 Hz (with HDA280) 250 - 8000 Hz (with B71W) • Range stimuli level -10 up to 120 dB HL TEST TYPES • Frequency < 0.5% • Distortion < 1% • Attenuator linearity 1 dB per 5 dB step, max 3 dB whole range USER INTERFACE • Via cable through USB port • Pure tone: sine wave 125 to 8 KHz signal (to 12.5 KHz for HDA280 phones) • Warble: ± 5% frequency sine wave modulated, modulation: sine wave 5 Hz • Narrow band noise: 24 dB/oct filtered noise • Speech noise: 1 kHz 12 dB/oct filtered noise • White noise • External signal • External mike • Speech material recorded on SD card • Master Hearing Aid: 1 KHz 6, 12, 18 , 24 dB High pass filters • On/Off rise – fall time: 40msec COMMUNICATION PORT OUTPUT TRANSDUCERS • Built-in fast thermal printer with paper width: 112 mm supplied as standard part • Printed on thermal printer • .pdf report created 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 • 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: 0.15 A • Power consumption: 40 VA 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 700 hPa up to 1060 hPa • ACR, ACL: 10 ohm DD45 matched pair earphone, alternatively HDA280 Sennheiser. IP30 Insert earphones (optional) • BC: B71W Radioear; B81 (optional) • INSERT: Insert transducer • Free field output: 600 ohm impedance STIMULUS PRESENTATION MODALITY • Presentation: Normal, Reverse, Extended (present tone for 1 second from 20 dB below the maximum level) • Modality: Continuous, Pulsed (rate 0.5, 1 and 2 Hz), Alternated (ABLB and MLB 0.5, 1 and 2 Hz) • DLI increment levels: 0.1 in steps of 0.1dB up to 1.0 dB; 1.5, 2, 3, 4, 5 dB • DLI increment recurrence rates: 0.5 Hz, 1 Hz, 2 Hz • SISI increment recurrence rates: 0.2Hz, 0.5Hz, random. Time on 300 ms • SISI increment level: 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5 dB • Bekesy: mode sweep and fixed; Continuous, Pulsed and LOT; exam duration 30 sec and 60 sec. • MDD 93/42/EEC and its revised versions: Class IIa (as referred to in Annex IX, rule 10 of said MDD 93/42 EEC) • Safety: IEC 60601-1, 3rd edition, Class 1 Type B • EMC: IEC 60601-1-2 • Audiometer: to IEC 60645-1; IEC 60645-2 and ANSI S3.6 Type 1A STANDARD ACCESSORIES • DD45, ADC or HDA280 headset for audiometry testing • B71W bone conductor • Insert-Transducer (for bone conductor masking) • Operator headset with microphone and speaker (talk over and monitor) • Patient microphone (talk back) • Internal speaker as monitor use • Patient response pushbutton • Built-in fast thermal printer • 1 roll of thermal paper • Power supply cable (110 – 220 V) • 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) • Spare fuse OPTIONALS • USB external keyboard • Goose-neck microphone • Carrying bag • TDH39 headset • Pediatric Headset (AC or BC) • ADC Audiocups Noise reducing headset enclosures • IP30 insert earphones • B81 High Output Bone Conductor • MDS software license • Quick-SIN test license • Silent cabin cables • Free field loudspeaker • Additional patient response pushbutton QUALITY SYSTEM Manufactured, designed, developed and marketed under an ISO 13485, ISO 9001 certified quality system. Medical CE marks and FDA approval. 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 th