MRS4300102305 : R25C Audiomètre et impédancemètre de diagnostic combiné, configuration DD45

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    MRS4300102305 : R25C Diagnostic combined audiometer and middle ear analyzer, DD45 configuration


    Terms and Conditions

    GENERAL SPECIFICATION

    DIMENSIONS AND WEIGHT

    • L x W x H: 370x290x180 mm

    • Net weight: 3.5 kg

    • Body material: Bayblend® self-extinguishing

    TEST TYPES

    Tympanometry, Acoustic Reflex, Reflex Decay, Quick Check, Quick Screening, Pure Tone test, Autothreshold, ABLB, Speech Test, Stenger, GAP, DLF

    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

    “CHILDREN” FEATURE

    • To help keep the child distracted while running screening “Quick Check” a series of animated images appears on the color display

    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

    TYMPANOMETRY OPERATING SPECIFICATIONS

    PROBE TONE

    • 226 Hz for traditional Y-curve tympanometry

    INTENSITY

    • 226 Hz: 85dB SPL ± 2dB

    • Frequency Accuracy: ± 0,5%

    • Harmonic distortion: Less then 1%

    ADMITTANCE MEASUREMENTS

    • Compliance range at 226Hz: 0,05 up to 7ml

    • Sensitivity scale: Auto Scales to appropriate range, available scale at 226Hz 1.5, 2, 5 and 7ml

    AIR PRESSURE

    • Control: Automatic

    • Range: from +200 up to -400 daPa adjustable in 50 daPa steps

    • Pressure accuracy: +/- 10 daPa or +/- 10%

    • Sweep rate: 50, 100, 200,300 daPa/sec and automatic

    • Indicator: Measured value is displayed

    • Safety limitations: -800 up to +600 daPa

    ACOUSTIC REFLEX TESTS

    • Reflex test method: Threshold , Automatic, Manual

    • Stimulus duration: 0,5 , 1 or 2 sec.

    • User selectable protocols for all test methods

    • Ipsi or Contralateral stimulation for all reflex test

    • Automated peak search functions available for all test methods

    • Manual Reflex: Pump manual control of all stimuli

    • Reflex Decay: Threshold , Automatic, Manual

    • Stimulus duration: 10 or 20 sec.

    FREQUENCIES AND INTENSITY RANGES

    • Ipsilateral:

    - Pure tone level range (dBHL) from 50 to 110 

    - Noise level range (dBSPL) from 50 to 100

    • Frequency: 500, 1000, 2000, 3000, 4000 Hz, BBN,HP or LP noise

    • Accuracy: ±1%

    • Harmonic distortion (THD): less than 3%


    • Contralateral:

    - Pure tone level range (dBHL) from 50 to 120

    - Noise level range (dBSPL) from 50 to 115

    • Frequency: 250, 500, 1000, 2000, 3000, 4000, 6000, 8000 Hz, BBN,HP or LP noise

    • Accuracy: ±1%

    • Calibration accuracy ±3 dB

    • Level steps: 1 , 2, 5 or 10 dB

    • On/Off ratio: 70 dB minimum

    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

    • 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 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

    • Impedance: IEC 60645-5/ANSI S3.39 Type 2

    • Audiometer: to IEC 60645-1; IEC 60645-2 and ANSI S3.6, Type 2A

    STANDARD ACCESSORIES

    • Headband Probe 226 Hz)

    • Probe cleaning tool kit

    • DD45 for Contra

    • Kit of assorted ear tips; size from 6 mm up to 15 mm

    • Calibration cavity with probe holder

    • Built-in fast thermal printer

    • Thermal paper roll

    • Device dust cover

    • Multilingual Quick user’s handbook

    • Pen Drive

    • Resonance® MDS software with NOAH® module included (demo version)

    • Power supply cable (110 – 220V)

    • Spare fuse

    • DD45 or HDA280 headset for audiometry testing

    • B71W bone conductor

    • Patient microphone (talk back)

    • Patient response pushbutton

    • SD-card with Multilanguage speech material

    OPTIONALS

    • Kit of assorted silicone ear tips “MS” shape size from 8 mm up to 16 mm

    • External USB Keyboard

    • Carrying bag

    • Foot switch

    • Insert for Contra and bone conductor masking

    • TDH39 for Contra

    • TDH39 headset

    • Pediatric Headset (AC or BC)

    • ADC Audiocups Noise reducing headset enclosures

    • Goose-neck microphone

    • Various Insert earphones models

    • B81 High Output Bone Conductor

    • Silent cabin cables

    • Free field loudspeaker

    • Operator headset with microphone and speaker (talk over and monitor)

    • Additional patient response pushbutton

    • MDS software licence

    • Quick-SIN test


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