MRS4300102305 : R25C Diagnostic combine audiometer and middle ear analyzer

MRS4300102305 : R25C Diagnostic combine audiometer and middle ear analyzer


configuration DD45


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