MRS4300102640 : R37A Clinical 2-channel audiometer, HDA280 configuration

MRS4300102640 : R37A Clinical 2-channel audiometer, HDA280 configuration


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 - 12500 Hz

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