R37A-HF 2 Channel Tone and Speech Testing Clinical High Frequency Audiometer
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2 CHANNEL TONE AND SPEECH TESTING CLINICAL HIGH FREQUENCY 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, DLI, SISI, Bekesy, Tone Decay, MLB, Multifrequency, GAP, DLF (Difference Limen for Frequency), High frequency up to 20 KHz USER INTERFACE • Multilingual AUDIOMETRY OPERATING SPECIFICATIONS COMPLIANCE/REGULATORY STANDARDS Designed, tested and manufactured to meet the European and International Standards: • Frequency < 0,5% • Distortion < 1% • Attenuator linearity 1dB per 5dB step, max 3dB whole range • Range stimuli level -10 up to 120 dB HL • 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 • Pure tone: sine wave 125 to 8KHz signal (to 12,5KHz for HDA280 phones; to 20KHz for HDA300) • 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 • Master Hearing Aid: 1KHz 6, 12, 18 ,24dB High pass filters • On/Off rise – fall time: 40msec OUTPUT TRANSDUCERS • Built-in fast thermal printer with paper width: 112 mm supplied as standard part • 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 • ACR, ACL up to 8 KHz: 10 ohm DD45 matched pair earphone, (alternatively Insert earphones) • ACR, ACL up to 12,5 KHz: HDA280 Sennheiser • ACR, ACL up to 20 KHz: HDA300 Sennheiser • BC: B71-W Radioear; B81 (optional) • INSERT: Button receiver • Free field output: 600 ohm impedance • Monitor Phone: headset with boom microphone 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 and MLB - 0,5, 1 and 2 Hz) • DLI increment levels: 0,1 in steps of 0,1dB up to 1.0dB; 1,5-2-3.4.5 dB • DLI increment recurrence rates: 0.5Hz, 1Hz, 2Hz • SISI increment recurrence rates: 0.2Hz, 0.5Hz, random. Time on 300ms • 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 30sec and 60sec. • 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 1A (R37A) STANDARD ACCESSORIES • DD45 or HDA280 headset for audiometry testing • HDA300 headset for high frequency test • 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 – 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 • Carrying bag • TDH39 headset • Pediatric Headset (AC or BC) • ADC Audiocups Noise reducing headset enclosures • Various Insert earphones models • B81 High Output Bone Conductor • Pediatric Headset (AC or BC) • MDS software licence • Quick-SIN test licence • HF type 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 the