MRS4300102605 : R37A Audiomètre clinique 2 canaux, configuration DD45

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    MRS4300102605 : R37A Clinical 2-channel audiometer, DD45 configuration


    Terms and Conditions

    GENERAL 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)

    DISPLAY

    • 7” TFT Color display

    USER INTERFACE

    • Multilingual

    PRINTER

    • Built-in fast thermal printer with paper width: 112 mm supplied as standard part

    REPORTS

    • 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

    • 110-240V AC 50/60Hz 40VA

    • Fuses: 2 x T 1 A L 250V

    CONSUMPTION

    • 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

    AUDIOMETRY OPERATING SPECIFICATIONS

    RANGE

    • Frequency range:

    125 - 8000 Hz (with DD45)

    125 - 12500 Hz (with HDA280)

    250 - 8000 Hz (with B71-W)

    ACCURACY

    • Frequency < 0,5%

    • Distortion < 1%

    • Attenuator linearity 1dB per 5dB step, max 3dB whole range

    • Range stimuli level -10 up to 120 dB HL

    TYPE OF SIGNALS

    • 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

    • Master Hearing Aid: 1KHz 6, 12, 18 ,24dB High pass filters

    • 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

    • 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.

    QUALITY SYSTEM

    Manufactured, designed, developed and marketed under an ISO 13485, ISO 9001 certified quality system. Medical CE marks and FDA approval

    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 1A (R37A)

    STANDARD ACCESSORIES

    • DD45 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 – 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

    • Silent cabin cables

    • Free field loudspeaker

    • Additional patient response pushbutton


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