MRS4300102720 : R26M-ME Diagnostic full automatic middle ear analyzer

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    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

    Tympanometry, Acoustic Reflex, Reflex Decay, Quick Test, Quick Screening

    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 pressure: from 700hPa up to 1060hPa

    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 stimulation for all reflexes 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%

    Calibration accuracy ±3 dB

    Level steps: 1, 2, 5 or 10 dB

    On/Off ratio: 70 dB minimum

    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 S.3.39 Type 2

    STANDARD ACCESSORIES

    • Handheld Probe 226 Hz

    • Probe cleaning tool kit

    • 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

    OPTIONALS

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

    External USB Keyboard

    Carrying bag

    Foot switch

    MDS software licence


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