D-0101246-Q – 2022/05
Callisto™ Instructions for Use - US Page 32
3.2.4 Technical specifications of the AC440 software
The CE-mark in combination with MD symbol indicates that
Interacoustics A/S meets the requirements of the Medical Device
Regulation (EU) 2017/745 Annex I
Approval of the quality system is made by TÜV – identification no. 0123.
Tone: IEC60645-1 2017/ANSI S3.6 2018 Typ e 1 EHF
Speech: IEC60645-1 2017 /ANSI S3.6 2018 Type A or A-E
Transducers & Calibration:
Calibration inf ormation and instructions are in the Service Manual.
Check the accompanying Appendix f or RETSPL levels for transducers
ISO 389-1 2017, ANSI S3.6 2018 Headband Static Force 4.5N ±0.5N
ISO 389-1 2017, ANSI S3.6 2018 Headband Static Force 4.5N ±0.5N
PTB 1.61-4091606/18, AAU 2018 Headband Static Force 11.5N±0.5N
PTB report 1.61.4066893/13 Headband Static Force 8,8N ±0.5N
ISO 389-8 2004, ANSI S3.6 2018 Headband Static Force 10N ±0.5N
ISO 389-2 1998, ANSI S3.6 2018
ISO 389-2 1998, ANSI S3.6 2018
B81
ISO 389-3 2016, ANSI S3.6 2018 Headband Static Force 5.4N ±0.5N
ISO 389-3 2016, ANSI S3.6 2018 Headband Static Force 5.4N ±0.5N
ISO 389-7 2005, ANSI S3.6 2018
ISO 389-5 2004, ANSI S3.6 2018
ISO 389-4 1994, ANSI S3.6 2018
Talk Forward and Talk Back.
Output through external earphone or speaker.
Pure tone, Warble tone, NB, SN, WN, TEN noise, Wave files.
125-16000Hz separated in two ranges 125-8000Hz and 8000-16000Hz.
Resolution 1/2-1/24 octave.
1-10 Hz sine +/- 5% modulation
44100Hz sampling, 16 bits, 2 channels
Automatic selection of narrow band noise (or white noise) for tone
presentation and speech noise f or speech presentation.
IEC 60645-1:2001, 5/12 Octave f ilter with the same center f requency
resolution as pure Tone.
80-16000Hz measured with constant bandwidth
IEC 60645-1 2017 & ANSI S3.6 2018: 125-6000Hz falling 12dB/octave
above 1KHz +/-5dB
Manual or Reverse. Single or multiple pulses. pulse time adjustable from
200ms-5000ms in 50mS steps. Simultaneous or alternating.
Check the accompanying Appendix f or maximum output levels
Available Intensity Steps is 1, 2 and 5dB
Sound pressure levels: ± 2 dB
Vibration f orce levels: ± 5 dB
If not activated, the Air Conduction output will be limited to 20 dB below
maximum output.
Range: 125Hz to 8kHz (Optional High Frequency: 8 kHz to 16 kHz)
Accuracy: Better than ± 1 %
Sound pressure levels: below 1.5 %