MRS4300102605 : R37A Clinical 2-channel audiometer, DD45 configuration

MRS4300102605 : R37A Clinical 2-channel audiometer, DD45 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 - 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