Callisto Technical Specifications Page 1. Technical Specifications. Callisto Portable Audiometry, REM & HIT

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Transcription:

Callisto Technical Specifications Page 1 Technical Specifications Callisto Portable Audiometry, REM & HIT D-0105960-C 11/2015

Callisto Technical Specifications Page 2 Included and Optional Parts for the Callisto TM AC440 software Standard Parts for the Callisto Unit: Callisto TM Unit Callisto TM Suite DVD, incl. Instructions for use and Quick Guides. Callisto Carrying Bag Callisto Foam Insert (standard bag) Standard USB Cable (2m) Mouse Pad Optional Parts for the Callisto Unit Wheeled Carrying Case Callisto Foam Insert (optional bag with wheels) OtoAccess V1.01 Database CD, Complete AC440 REM440 HIT440 AC440 Standard Parts REM440 Standard Parts HIT440 Standard Parts: DD45 or TDH 39 Audiometric IHM60 In-situ Headset (kit) TBS10 Test Box Headset Probe Tubes 36 pcs 2cc coupler with MTH400 Monitor Headset Edifier Loudspeaker + Wire microphone and adaptors B71 Bone Conductor for ITE, BTE and Body Style APS3 Patient response button HA Coupler seal wax Reference microphone AC440 Optional Parts TDH39 Audiometric Headset REM440 Optional Parts HIT 440 Optional parts: HDA300 Audiometric Headset 30 Extra Edifier Loudspeaker + Wire Couplers 1.2CC and 0.6CC: plugs Callisto Coupler Base Kit which ITE, BTE, Ear simulator Eartone 3A Insert earphones 1) includes: Calibration adaptor Eartone 5A Insert earphones 1)) o Coupler Base IP30 Insert earphones o Coupler Box B71 Bone Conductor o Reference Microphone B81 Bone Conductor o 2cc Coupler Talk Back Microphone o ½ Microphone o BTE Adaptor with O Edifier Loudspeaker + wire o ITE Adaptor with O SP85A Loudspeaker o Body Adaptor with O SP90A Loudspeaker o BTE Tubing 26,5mm for BTE adaptor o SPL60 In-situ Probe Tip-set + Coupler Adaptor 1) Special Tests: o Coupler Seal Wax Optional special tests: High Frequency audiometry (HF440) Multi Frequency module (MF440) Speech from hard-drive (SFH440) SISI test Master Hearing Aid (MHA440), Hearing Loss Simulator (HLS440) Loudness Scaling (LS440) QuickSIN TEN test 1) Note patient contact parts for single use.

Callisto Technical Specifications Page 3 General Technical Specifications Callisto General Technical Specifications Medical CE-mark: The CE-mark indicates that Interacoustics A/S meets the requirements of Annex II of the Medical Device Directive 93/42/EEC. Approval of the quality system is made by TÜV identification no. 0123. Standards: Safety: IEC/ES 60601-1, 2005 CAN/CSA-C22.2 No. 601.1-M90 IEC 60601-1 1988.A1:1991, A2:1995 UL 60601-1:2003 Class I, Type B IEC 60601-1-1 2000 EMC: IEC 60601-1-2 :2007 Audiometer Tone: IEC 60645-1 2001/ANSI S3.6-2010, Type 1 Tone audiometer IEC 60645-4 1994/ANSI S3.6-2010, High frequency audiometer Audiometer Speech: IEC 60645-2 1997/ANSI S3.6-2010 Type A or A-E, STAF- 1996, Norway. Speech audiometer Audiometer AC: DD45 PTB/DTU report 2009 Calibration: TDH39: ISO 389-1 1998, ANSI S3.6-2010 HDA200: ISO 389-5 2006, ANSI S3.6-2010 E.A.R Tone 3A/5A: ISO 389-2 1994, ANSI S3.6-2010 BC: B71: ISO 389-3 1994, ANSI S3.6-2010 FF: ISO 389-7 2005, ANSI S3.6-2010 HF: ISO 389-8 2004, ANSI S3.6-2010 Effective masking: ISO 389-4 1994, ANSI S3.6-2010 Hearing Aid Analyzer: Real ear measurement: Specifications Callisto Hardware: PC requirements: Supported Systems: Available modules: Database: Computer Communication: Construction: Power: IEC 60118-0 1983, IEC60118-1 1998, IEC 60118-7 2005, ANSI S3.22-2003. IEC61669 2001, ISO12124 2001, ANSI S3.46-1997 1.6 GHz Dual core CPU or better (Intel recommended) 1GB RAM or more. (Windows 8: 1GB 32-bit; 2GB 64-bit) Hard drive with min 20 GB of free space. Minimum display resolution of 1024x768 pixels (1280x1024 or higher recommended) DirectX 9 graphics with WDDM 1.0 or higher. (Intel/Nvidia recommended) One or more USB ports, version 1.1 or higher. DVD-Rom drive. Windows XP (SP2 or later and compatible), Windows VISTA Windows 7 (32 and 64 bit) Window 8 (32 and 64 bit) Callisto Suite AUD, REM. OtoAccess and Noah-compatible office systems or later releases USB interface, compatible with USB1.1 or later. Plastic cabinet. USB-powered with an internal power boost rechargeable battery and load balancer.

Callisto Technical Specifications Page 4 Battery : Battery working voltage : Operation environment: Rel. Humidity: Temperature: Ambient Pressure: NP120 3.7V 1700 mah battery lithium ion 53x35.2x11. 3.2 to 4.2V 30 90% 15-35 98 kpa 104 kpa Transport temperature: -20-50 C Storage temperature: 0-50 C Humidity transportation & storage: 10% to 95% RH. Non condensing Dimensions: Weight: 212 x 121 x 44 mm / 8.3 x 4.8 x 1.7 inches 1.25 lbs (822g / 1.81 lbs with cradle)

Callisto Technical Specifications Page 5 Technical Specifications of the AC440 Software Medical CE-mark: The CE-mark indicates that Interacoustics A/S meets the requirements of Annex II of the Medical Device Directive 93/42/EEC. Approval of the quality system is made by TÜV identification no. 0123. Audiometer Standards: Tone: IEC60645-1/ANSI S3.6 Type 1 Speech: IEC60645-2/ANSI S3.6 Type A or A-E Transducers & Calibration: Calibration information and instructions are located in the Service manual. Check the accompanying Appendix for RETSPL levels for transducers Air Conduction DD45 PTB/DTU report 2009 Headband Static Force 4.5N 0.5N TDH39 ISO 389-1 1998, ANSI S3.6-2010 Headband Static Force 4.5N 0.5N HDA300 ISO 389-8 2006, ANSI S3.6-2010 Headband Static Force 8,8N 0.5N HDA280 PTB report 2004 Headband Static Force 5N 0.5N E.A.R Tone 3A/5A IP30 CIR 33 ISO 389-2 Bone Conduction B71 B81 Free Field High Freqency Effective masking Patient Response switch: Patient communication: Monitor: Stimuli: Tone Warble Tone Wave file Masking Narrow band noise: White noise: Speech Noise. Presentation Intensity Steps Accuracy Extended range function ISO 389-2 1994, ANSI S3.6-2010 ISO 389-2 1994, ANSI S3.6-2010 DES-2361 Placemenet: Mastoid ISO 389-3 1994, ANSI S3.6-2010 ISO 389-3 1994, ANSI S3.6-2010 ISO 389-7 2005, ANSI S3.6-2010 ISO 389-5 2004, ANSI S3.6-2010 ISO 389-4 1994, ANSI S3.6-2010 Hand held push button. Talk Forward and Talk Back. Output through external earphone or speaker. Pure tone, Wable tone,nb, SN, WN, TEN noise Headband Static Force 5.4N 0.5N Headband Static Force 5.4N 0.5N 125-20000Hz separated in two ranges 125-8000Hz and 8000-20000Hz. 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 for speech presentation. IEC 60645-1:2001, 5/12 Octave filter with the same centre frequency resolution as pure Tone. 80-20000Hz measured with constant bandwidth IEC 60645-2:1993 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 for maximum output levels Available Intensity Steps is 1, 2 or 5dB Sound pressure levels: ± 2 db. Vibration force levels: ± 5 db. If not activated, the Air Conduction output will be limited to 20 db below maximum output. Frequency Range: 125Hz to 8kHz (Optional High Freqency: 8 khz to 20 khz) Accuracy: Better than ± 1 % Distortion (THD) Sound pressure levels: below 1.5 % Vibration force levels: below 3 %. Signal Indicator(VU) Time weighting: 350mS Dynamic range: -20dB to +3dB Rectifier characteristics: RMS Selectable inputs are provide with an attunuator by which the level can be adjusted to the indicator reference position(0db) Storing capability: Tone audiogram: db HL, MCL, UCL, Tinnitus, R+L Speech Audiogram: WR1, WR2, WR3, MCL, UCL, Aided, Unaided, Binaural, R+L. Compatible Software: Noah 4, Noah 3.7, OtoAccess TM and XML compatible

Callisto Technical Specifications Page 6 Medical CE-mark: Real Ear Measurement Standards: Stimuli: Frequency range: Technical Specifications - REM440 Software Frequency Less than ± 1 % accuracy: Distortion: Less than 2% Intensity range: The CE-mark indicates that Interacoustics A/S meets the requirements of Annex II of the Medical Device Directive 93/42/EEC. Approval of the quality system is made by TÜV identification no. 0123. IEC 61669, ISO 12124, ANSI S3.46. Warble Tone, Pure Tone, Random noise, Pseudo random noise, Band limited white noise, Chirp, ICRA, Real Speech, any other sound file (automatic calibration available). 100Hz 10kHz 40 90 db Intensity accuracy: Less than ± 1.5 % Measurement Intensity Range: Frequency Resolution: Probe microphone: Reference microphone: Intensity Accuracy: Cross talk Available tests: Compatible Software: Probe microphone 40-140 db SPL ± 2 db. 1/3, 1/6, 1/12, 1/24 octave or 1024 point FFT. Intensity: 40 140 db Intensity: 40 100 db Less than ± 1.5 db Cross talk in the probe and probe tube will alter the obtained results with less than 1 db at all frequencies. REUR REOR REIG REOG RECD REUG REAR Input Output REAG Noah 4, Noah 3.7, OtoAccess TM and XML compatible

Callisto Technical Specifications Page 7 Medical CE-mark: Hearing Aid Analyzer Standards: Frequency Range: Frequency Resolution: HIT440 Software - Technical Specifications The CE-mark indicates that Interacoustics A/S meets the requirements of Annex II of the Medical Device Directive 93/42/EEC. Approval of the quality system is made by TÜV identification no. 0123. IEC 60118-0, IEC 60118-7, ANSI S3.22. 100-10000Hz. Frequency Accuracy: Less than ± 1 % Stimulus Signal: Sweep Speed: FFT: Stimulation Intensity Range: Intensity Accuracy: Measurement Intensity Range: Stimulus Distortion: Available tests: Pre-Programmed Protocols: Compatible Software: 1/3, 1/6, 1/12 and 1/24 octave or 1024 point FFT. Warble Tone, Pure Tone, Random noise, Pseudo random noise, Band limited white noise, Chirp, ICRA, Real Speech, any other sound file (automatic calibration available). 1,5 12 sec. Resolution 1024 points. Averaging: 10 500. 40-100 db SPL in 1 db step. Less than ± 1.5 db Probe microphone 40-145 db SPL ± 2 db. Less than 1 % THD. Additional tests can be designed by user OSPL90 Full On Gain Input/Output Attack/Recovery Time Reference Test Gain Frequency Response Equivalent Input Noise Harmonic Distortion Intermodulation Distortion Microphone Directionality HIT440 software comes with a set of Test Protocols loaded. Additional Test Protocols can be designed by user, or easily imported into the system. Noah 3.7, Noah 4,, OtoAccess TM and XML compatible