MRS4300102825 : R36M-PT Clinical middle ear analyzer

MRS4300102825 : R36M-PT Clinical middle ear analyzer


GENERAL SPECIFICATIONS

DIMENSIONS AND WEIGHT

  • L x W x H: 370 x 290 x 180 mm

  • Net weight: 3.5 kg

TEST TYPES

Tympanometry, Acoustic Reflex, Reflex Decay, nr. 3 Quick Tests, Acoustic Reflex Latency Test (ARLT), ETF (Intact, Perforated and Patulous), Special tests (Growth-DLI and Non-acoustic), Multifrequency Tympanometry

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 created 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 involved while running screening “Quick Check” or “Tympanometry HF”, a series of animated images appears on the color display

DATA TRANSFER TO PC

  • Via cable through USB port

COMMUNICATION PORT

  • Nr.1 USB host type A

  • Nr.1 USB slave type B

WINDOWS® COMPATIBLE SOFTWARE

  • Resonance MDS Management Data Suite

TYMPANOMETRY OPERATING SPECIFICATIONS

PROBE TONE

  • 226 Hz for Admittance (Y) curve tympanometry

  • 1000 Hz for Admittance (Y) curve tympanometry with added Susceptance (B) and Conductance (G) curves

INTENSITY

  • 226 Hz: 85 dB SPL ± 2dB

  • 678, 800 and 1000 Hz: 75 dB SPL ± 2 dB

  • Frequency Accuracy: ± 0.5%

  • Harmonic distortion: Less than 1%

ADMITTANCE MEASUREMENTS

  • Compliance range at 226 Hz: 0.05 up to 7 ml

  • Sensitivity scale: Autoscale to appropriate range; available scale at 226 Hz: 1.5, 2, 5 or 7 ml

  • Compliance range at 678, 800 and 1000 Hz: 0 to +25 mmho

  • Sensitivity scale HF: Autoscale to appropriate range, available scales at 678, 800 and 1000 Hz: 5, 10, 15, 20, 25 mmho

AIR PRESSURE

  • Control: Automatic and Manual

  • Range: from +400 up to -600 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

EUSTACHIAN TUBE FUNCTION

  • ETF test for use with both intact and perforated eardrums

  • Available also test for patulous tympanic membrane

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.

  • ARLT: Threshold, Automatic, Manual

  • Stimulus duration: 1 sec. fixed

  • Non-Acoustic: 10/20 sec.

FREQUENCIES AND INTENSITY RANGES

Ipsilateral:

  • Pure tone level range (dB HL) from 50 to 110

  • Noise level range (dB SPL) from 50 to 100

  • Frequency: 500, 1000, 2000, 3000, 4000 Hz

  • Noise: BBN, HP or LP

  • Frequency accuracy: ±1%

  • Harmonic distortion (THD): less than 3%

Contralateral:

  • Pure tone level range (dB HL) from 50 to 120

  • Noise level range (dB SPL) from 50 to 115

  • Frequency: 250, 500, 1000, 2000, 3000, 4000, 6000, 8000 Hz

  • Noise: BBN, HP or LP

  • Frequency accuracy: ±1%

  • 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 mark and FDA approval.

COMPLIANCE/REGULATORY STANDARDS

Designed, tested and manufactured to meet the European and International Standards:

  • MDD 93/42/EEC and its revised versions: Class IIa (as referred to in Annex IX, rule 10 of said MDD 93/42 EEC)

  • Safety: IEC 60601-1, 3rd edition, Class 1 Type B

  • EMC: IEC 60601-1-2

  • Impedance: IEC 60645-5/ANSI S.3.39 Type 1

STANDARD ACCESSORIES

  • Probe HF

  • Headband and probe handle

  • Probe cleaning tool kit

  • DD45 for Contra

  • Insert 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 – 220 V)

  • Spare fuse

OPTIONALS

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

  • External USB Keyboard

  • TDH39 for Contra

  • Carrying bag

  • MDS software license