MRS4300102405 : R35C Audiomètre et impédancemètre clinique combiné, configuration DD45
MRS4300102405 : R35C Clinical combined audiometer and middle ear analyzer, DD45 configuration
GENERAL SPECIFICATION
DIMENSIONS AND WEIGHT
L x W x H: 370x290x180 mm
Net weight: 3.5 kg
TEST TYPES
Tympanometry: Automatic 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)
Audiometry: Pure Tone test, Autothreshold, ABLB, Speech Test, Stenger DLL, SISI, Bekesy Tone Decay, MLB, Multifrequency, GAP, DLF
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 700 hPa up to 1060 hPa
TYMPANOMETRY OPERATING SPECIFICATIONS
PROBE TONE
226 Hz for 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 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 (all version)
Noise level range (dB SPL) from 50 to 115 (all version)
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
AUDIOMETRY OPERATING SPECIFICATIONS
RANGE
Frequency range:
125 - 8000 Hz (with DD45)
125 - 12500 Hz (with HDA280)
250 - 8000 Hz (with B71-W)
Range stimuli level -10 up to 120 dB HL
ACCURACY
Frequency < 0,5%
Distortion < 1%
Attenuator linearity 1dB per 5dB step, max 3dB whole range
TYPE OF SIGNALS
Pure tone: sine wave 125 to 8Khz signal
Warble: +/- 5% frequency sine wave modulated, modulation: sine wave 5 Hz
Narrow band noise: 24dB/oct filtered noise
Speech noise: 1khz 12dB/oct filtered noise
White noise
External signal
External mike
Speech material recorded on SD card
Master Hearing Aid: 1 KHz 6, 12, 18 ,24 dB High pass filters
On/Off rise – fall time: 40msec
OUTPUT TRANSDUCERS
ACR, ACL: 10 ohm DD45 matched pair earphone, alternatively HDA280 Sennheiser. IP30 Insert earphones (optional)
BC: B71-W Radioear; B81 (optional)
INSERT: Insert transducer
Free field output: 600 ohm impedance
STIMULUS PRESENTATION MODALITY
Presentation: Normal, Reverse, Extended (present tone for 1 second from 20 dB below the maximum level)
Modality: Continuous, Pulsed (rate 0.5, 1 and 2 Hz), Alternated (ABLB and MLB 0.5, 1 and 2 Hz)
DLI increment levels: 0.1 in steps of 0.1dB up to 1.0 dB; 1.5, 2, 3, 4, 5 dB
DLI increment recurrence rates: 0.5 Hz, 1 Hz, 2 Hz
SISI increment recurrence rates: 0.2 Hz, 0.5 Hz, random. Time on 300 ms
SISI increment level: 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5 dB
Bekesy: mode sweep and fixed; Continuous, Pulsed and LOT; exam duration 30 sec and 60 sec.
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 1
Audiometer: to IEC 60645-1; IEC 60645-2 and ANSI S3.6, Type 1A
STANDARD ACCESSORIES
Probe 226 Hz
Headband and probe handle
Probe cleaning tool kit
DD45 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 – 220V)
Spare fuse
DD45, ADC or HDA280 headset for audiometry testing
B71W bone conductor
Patient microphone (talk back)
Patient response pushbutton
SD-card with Multilanguage speech material
Insert-Transducer (for bone conductor masking and contralateral reflex)
Operator headset with microphone and speaker (talk over and monitor)
OPTIONALS
Kit of assorted silicone ear tips “MS” shape size from 8 mm up to 16 mm
External USB Keyboard
Carrying bag
TDH39 for Contra
TDH39 headset
Pediatric Headset (AC or BC)
ADC Audiocups Noise reducing headset enclosures
Goose-neck microphone
IP30 Insert earphones
B81 High Output Bone Conductor
Silent cabin cables
Free field loudspeaker
Additional patient response pushbutton
MDS software license
Quick-SIN test