L x W x H: 19.7 cm x 10.2 cm x 4.5 cm
Shipping Weight: 0.57 Kg
Test Types: Distortion Product Otoacoustic Emissions, Transient Evoked Otoacoustic Emissions and Auditory Brainstem Response
Screening Methods: Presence/Absence (DPOAE & ABR), Level (DPOAE & TEOAE), or Latency (ABR)
Display: Pass/Refer/Noise or Graphical
Reports: Simple or Detailed
ABR tests: Using Comfort Cups or Probe – protocols included
Storage: Up to 300 patients
Data Transfer: Infrared to computer or printer
DPOAE OPERATING SPECIFICATIONS
Frequency Range: 2,000 Hz to 6,000 Hz, ±2%
Frequency Resolution: 50Hz
Level Measurement Accuracy: ± 1 dBSPL
Dynamic Range: 96 dB
Test Time: Varies dependent on parameters selected
Automated pass criteria:
DPOAE SNR and/or DPOAE Level
TEOAE OPERATING SPECIFICATIONS
Frequency Range: 250 Hz to 5,250 Hz, ±2%
Frequency Resolution: 50Hz
Level Measurement Accuracy: ± 1 dBSPL
Dynamic Range: 96 dB
Test Time: Varies dependent on parameters selected
Automated pass criteria:
TEOAE SNR and TEOAE Reproducibility
ABR OPERATING SPECIFICATIONS
Stimulus types: Click 100 _sec width, Blackman
window tone pips (500Hz, 1KHz, 2KHz,4KHz)
Stimulus Polarity: Rarefaction, Condensation, Alternating Stimulus Rate: 32 to 62 per second
Stimulus Intensity: 0 to 100dB in 5dB steps
Level Measurement Accuracy: ± 1 dBSPL
Input Frequency Range: 30Hz to 3,000Hz
Waveform latency Delay: ±0.2 msec
Common mode Rejection: 108 dB
Gain: 43 dB
Automated Impedance Testing
Automated Pass criteria:
ABR Fsp
POWER
Power AC Adaptor: 100-240VAC
Line Frequency Range: 50 to 60 Hz
BATTERY
NiMH 2150 mAh
Operating life: Approximately 24hrs
Recharge time: Approximately 2hrs
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SYSTEM CONFIGURATION
Each AUDIOscreener™ comes with AUDIOtrac™, a Windows based patient database software package.
SYSTEM REQUIREMENTS FOR AUDIOtrac
Windows Operating system (95, 98, 2000, ME, XP, or NT)
CD-ROM Drive
5 Mb or more available space on Hard drive
3.5”, 1.44 Mb floppy disk drive
An Infrared port (IrDA) set to COM 1.
For systems that do not have an IrDA as standard a special IrDA is provided.
Screen resolution 800x600 or larger
ENVIRONMENTAL
Temperature:
Storage: 0°C to 50°C
Operating: 10°C to 40°C
Humidity: up to 95%, (non-condensing)
ALARMS
Low Battery, Dead Battery
Database Error
Internal Circuit Error
QUALITY SYSTEM
Manufactured, designed, developed and marketed by VIASYS Healthcare Inc. NeuroCare Group under ISO 13485, ISO 9001 certified quality system.
COMPLIANCE / REGULATORY STANDARDS
Designed, tested and manufactured to meet the
following domestic (USA), Canadian, European and International Standards:
UL 2601-1 Standard for Safety Medical Equipment
IEC 601-1-2 Medical Electrical Equipment CISPR 11
(EN55011)
IEC 1000-4-2, IEC 1000-4-3, IEC 1000-4-4, IEC
1000-4-5 EN 61000-4-11 IEC 10000-4-8
ANSI S3.6-1996 IEC 60601-2-26 IEC 60601-2-40 IEC 60645-3
CSA C22.2, No. 601-1
CE 0344 – the CE mark on this product indicates that it conforms with the 93/42/EEC Medical Device Directive.
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