Essential performance
The device has no essential performance as defined by IEC 60601-1:2005+AMD1:2012.
Classification: Group 1, class A IEC 60601-1-2:2007
Type of protection against electric shock: Class II equipment
Degree of protection against electric shock: Type B applied part
Degree of protection against liquid penetration: IPXO
Mode of operation: Continuous operation
Tympanometer
Test frequency: 226 Hz
Frequency accuracy: ± 1%
Test level: 85 dB SPL in 2 ml ± 3 dB. Level may be altered in smaller or larger ear canals.
Pressure: -300 to +200 daPa
THD: < 1% in 2 ml
Measurement range: 0.1 to 6.0 ml
Rate of pressure change: 350 daPa/s in 2 ml
Tympanometry accuracy description
Min. TW, 5% error: 38 daPa
Min. TW, 10% error: 31 daPa
Min. SA, 5% error: 31 daPa
Min. SA, 10% error: 23 daPa
Reflex measurements
Pure tone signals: 500 Hz, 1 kHz, 2kHz, 3kHz, 4kHz ± 2%
Test method: Ipsilateral and contralateral (contralateral: T840 only)
Probe level range: 80 dB HL to 110 dB HL in 2 ml ± 3 dB. No artifacts should be expected at any
level.
THD: < 2.5% in 2 ml for TDH-39 and < 5% in 2 ml for insert phones
Step size: 5 dB
Temporal characteristics
Rise/fall time: 50 ms
Stimulus On time: 460 ms
Stimulus Off time: 860 ms
On-Off ratio: 70 dB (for stimulus level > 95 dB HL)
A weighted SPL in Off: < 25 dB
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User Guide
Inmedico A/S - T830/T840