Main technical specifications
Dimensions
•
L x W x H: 370x290x180 mm Weight: 3.5 kg net
Power Supply
•
110-240 V AC 50/60 Hz 40 VA Fuses: 2 x T 1 A L 250 V
Reference 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: to IEC 60601-1:2005 + AMD1:2012 Class 1 Type B
•
EMC: to IEC 60601-1-2 (2012)
•
Middle ear analyzer (Instruments for the measurement of aural acoustic impedance/admittance):
to EN 60645-5; ANSI S3.39 Type 1
•
Manufacturer quality system: to EN ISO 9001:2015 and UNI EN ISO 13485:2016 (Notified certification
body: IMQ)
Tests
•
Tympanometry (manual and automatic, absolute and compensated)
•
Multifrequency Tympanometry (probe tones 678 Hz, 800 Hz, 1000 Hz. Y-B-G track visualization)
"Children" function available with 1000 Hz probe tone
•
Quick test options (two quick reflex and one quick decay test preceded by tympanometry, designed
with rapid screening settings). "Children" function available for Quick Check Test.
•
Special tests (Growth-DLI and Non acoustic)
•
Reflex, Decay, ARLT (manual, automatic and threshold mode options with peak detection or at 0daPa)
•
ETF (three test options: Eustachian tube functionality for both intact, perforated and patolous
tympanic membrane)
Tympanometry
•
Probe tone frequency: 226 Hz, 678 Hz, 800 Hz, 1000 Hz accuracy ±1%
•
Probe tone intensity: 85 dB spl ±2 dB (226 Hz); 75 dB spl ±2 dB (678 Hz, 800 Hz, 1000 Hz)
•
Pressure range: +400 daPa / –600 daPa adjustable in 50 daPa steps
•
Pressure accuracy: ±10 daPa or ±10%
•
Pressure generation speed (pump speed): 50, 100, 200, 300 daPa/s and Automatic
•
Compliance range: 0.05 ml – 7 ml
•
Compliance accuracy: ±0.1 ml or ±5%
Reflex, Decay and ARLT test max frequencies and max levels
freq.
IPSI (Probe)
(Hz)
250
----
500
100
1000
105
2000
110
3000
105
4000
100
6000
----
8000
----
BBN
100
LPN
100
HPN
100
46
Tone (dB HL) - Noise (dB SPL)
CONTRA
IPSI (Probe HF)
(DD45-TDH39)
----
100
105
110
105
100
----
----
100
100
100
CONTRA (Insert)
100
90
120
110
120
110
120
110
120
110
120
110
115
105
100
90
115
105
115
105
115
105