MRS4300102705 : R26M-ME Diagnostic middle ear analyzer

MRS4300102705 : R26M-ME Diagnostic middle ear analyzer


full automatic, 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 R16M

  • Tympanometry, Reflexes, nr.1 Quick Test with editable protocols, High Frequency Tympanometry

DISPLAY

  • 7” TFT Resistive touch screen display

  • 800 by 480 resolution at 133 pixels per inch (ppi) 262K colors

USER INTERFACE

  • Intuitive icon system

  • Internal patient database

REPORTS

  • Data transfer to PC with Resonance Management Data Suite installed

  • Dedicated report template

DATA TRANSFER TO PC

  • Bluetooth 2.1

USB PORT

  • Nr.1 USB host type A (pen drive connection for software upgrade)

  • Nr.1 mini USB slave

WINDOWS® COMPATIBLE SOFTWARE

  • Resonance MDS Management Data Suite

MAIN SYSTEM COMPONENTS

  • Operative system: Microsoft® Windows® Embedded Compact

  • CPU: TEGRA® 2 dual core @ 1Ghz

POWER

POWER SUPPLY

  • Built-in 3,6V/3,1 Ah rechargeable lithium-ion battery

  • External Medical power supply/charger: Input 100-240Vac / 0,3A - 50/60Hz; Output +5Vdc / 2A

CONSUMPTION (WITH RECHARGEABLE BATTERY)

  • Up to 2 hours of continuous testing.

  • Charge time with external medical power supply: up to 80% in 2 hours

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 Admittance (Y) curve tympanometry

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

  • The probe is supplied in handheld mode

INTENSITY

  • 226 Hz: 85dB SPL ± 2dB

  • 1000 Hz: 75dB SPL ± 2dB

  • Frequency Accuracy: ± 0,5%

  • Harmonic Distortion (THD): 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, 2, 5 and 7ml

  • 1000 Hz: 0 to +25 mmho

  • Sensitivity scale: Auto Scales to appropriate range, available scales 5, 10, 15, 20, 25 mmho

AIR PRESSURE

  • Control: Automatic

  • Range: two selections available: +100/-200 daPa or +200/-400 daPa

  • Pressure accuracy: ±10 daPa or ±10%

  • Sweep rate: automatic adaptive speed control or fast (200 daPa/sec)

  • Indicator: Measured value is displayed

  • Safety limitations: -750 up to +550 daPa

ACOUSTIC REFLEX TESTS

  • Reflex test method: Threshold and Fixed level

  • Stimulus duration: 0,5 or 1 sec.

  • User selectable protocols for all test methods

  • Ipsi or Contralateral stimulation for all reflex test

  • Automated peak search functions available for Quick Test

FREQUENCIES AND INTENSITY RANGES

  • Ipsilateral: - Pure tone level range (dBHL) from 50 to 100

  • Frequency: 500, 1000, 2000, 4000 Hz

  • Accuracy: ±1%

  • Harmonic distortion (THD): less than 3%

  • Contralateral: - Pure tone level range (dBHL) from 50 to 115

  • Frequency: 500, 1000, 2000, 4000

  • Accuracy: ±1%

  • Calibration accuracy ±3 dB

  • Level steps: 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.

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 edition, Class II Type BF

  • EMC: IEC 60601-1-2

  • Impedance: IEC 60645-5 and ANSI S 3.39

STANDARD ACCESSORIES

  • Probe HF

  • Insert for Contra

  • Kit of assorted ear tips; size from 6 mm up to 15 mm

  • Calibration cavity

  • Resonance® MDS Software

  • Medical Power supply (100Vac – 240Vac)

  • Carrying bag

  • Charging Cradle

  • Pen Drive (with Multilingual Quick user’s handbook)

  • Touch screen pen

OPTIONALS

  • Headband with DD45 for Contra

  • Insert phones for Contra

  • External USB Keyboard

  • USB Videotoscope

  • Wallmount kit