MRS4300102745 : R26M-PT Diagnostic mutifrequency probe tone 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