MRS4300102825 : R36M-PT Impédancemètre clinique
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