MRS4300102720 : R26M-ME Diagnostic full automatic middle ear analyzer

MRS4300102720 : R26M-ME Diagnostic full automatic middle ear analyzer


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