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Ad528 Technical Specifications

The document provides technical specifications for the AD528 audiometric instrument, including included and optional parts, general technical specifications, and audiometry measurement systems. It outlines safety standards, operational environments, and various features such as frequency range and internal storage capacity. Additionally, it details the specifications for different audiometric components and their performance metrics.

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0% found this document useful (0 votes)
3 views5 pages

Ad528 Technical Specifications

The document provides technical specifications for the AD528 audiometric instrument, including included and optional parts, general technical specifications, and audiometry measurement systems. It outlines safety standards, operational environments, and various features such as frequency range and internal storage capacity. Additionally, it details the specifications for different audiometric components and their performance metrics.

Uploaded by

johnhuynh1410
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Download as PDF, TXT or read online on Scribd
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Technical Specifications

AD528

D-0121288-B – 2020/05

D-0121388-B – 2020/05
AD528 – Technical Specifications Page 0
Included and optional parts
Included parts
AD528 instrument
Power supply UES24LCP-120200SPA
Audiometric headset DD45 1/IP301
Bone conductor B711
Patient response APS31
Instructions for use Multilingual

Optional parts
Audiometric headset DD4501/IP301/DD451/DD65v21
Insert masking transducer IP30 single1
Monitor headset MTH400m
Talk back EM400 Electret Microphone/EMS400 Electret Microphone
Free field speakers SP90 w. amplifier/SP90A
Printer HM-E300 printer/A4 printer (HP PLC 3/HP PLC3GUI)
Diagnostic Suite software/ ADI Sync
OtoAccess® database Patient database

11 Applied part according to IEC60601-1

D-0121388-B – 2020/05
AD528 – Technical Specifications Page 1
General technical specifications
General
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 no0123
Standards: Safety: IEC 60601-1 2005/EN 60601-1 2006 and A1 2012
ANSI/AAMI ES60601-1:2005/(R)2012
CAN/CSA-C22.2 No. 60601-1:14
Class II, Type B applied parts
EMC: IEC 60601-1-2 (2014)
Audiometer: Tone Audiometer: IEC 60645 -1 (2017), ANSI S3.6 (2010),
Type 2
Speech Audiometer: IEC 60645-1 (2017)/ANSI S3.6 (2010)
type B or B-E.
Auto threshold tests: ISO 8253-1 (2010)
Operation Temperature: 15-35 °C
environment: Relative humidity: 30-90%
Ambient pressure: 98kPa – 104kPa
Warm-up time: 1 minute
Transport & Storage temperature: 0°C-50°C
storage: Transport temperature: -20-50 °C
Rel. humidity: 10-95%
Internal battery CR2032 3V, 230mAh, Li
PC control: USB: Input/output for computer communication.
Diagnostic Suite, OtoAccess®, NOAH, Audiometric data
interface (ADI).
Printer Thermal HM-E300
(optional): Direct print Printer language: HP PCL 3/HP PCL3 GUI
Use only specified power supply unit type
Power supply UES24LCP-120200SPA Input: 100-240VAC 50/60 Hz, 500mA
Output: 12.0 VDC 2.0A
Dimensions HxWxL 11 x 28 x 36 cm
4.3 x 11 x 14 inches
AD528 weight 1.5 kg / 3.3 lb
Display 5 inch high resolution color display 480x272

D-0121388-B – 2020/05
AD528 – Technical Specifications Page 2
Audiometry measure system
Air Conduction DD45: ANSI S3.6 2018 / ISO 389-1 2017 Headband Static Force 4.5N ±0.5N
DD450: ANSI S3.6 - 2018 Headband Static Force 10N ±0.5N
DD65v2: ANSI S3.6 - 2018 Headband Static Force 10N ±0.5N
IP 30: ISO 389-2 1994, ANSI S3.6-2018
Bone Conduction B71: ISO 389-3 1994, ANSI S3.6-2010 Headband Static Force 5.4N ±0.5N
Placement: Mastoid
Free Field ISO 389-7 2005, ANSI S3.6-2010
Effective masking ISO 389-4 1994, ANSI S3.6-2010
Patient response One handheld push button
Patient Talk forward (TF) and Talk back (TB)
communication
Monitor Output through built-in speaker, monitor headset or speaker
Special tests/test SISI, ABLB, Stenger, Tone in noise (Langenbeck), Speech Ch2,
battery Auto threshold tests: Available time for patient to respond 1 or 2 s: Same as tone
presentation, increment 5 dB.
Warble 1-10 Hz sine +/- 5% modulation
Wave file 44100 Hz sampling, 16 bits, 2 channels
Masking Automatic selection of narrow band noise (or white noise) for tone presentation and
speech noise for speech presentation.
Narrow band noise: IEC 60645-1:2017, 5/12 Octave filter with the same center
frequency resolution as pure Tone.
White noise:80-8000 Hz measured with constant bandwidth
Speech Noise: IEC 60645-1:2017 125-6000 Hz falling 12 dB/octave above 1 KHz +/-5
dB
Presentation Manual or reverse. Single or multiple pulses.
Auto testing: duration 1-2 s adjusted in 0.1 s intervals
Intensity Check the accompanying Appendix.
Available Intensity Steps is 1, 2 or 5 dB
Extended range function: If not activated, the Air Conduction output will be limited to 20
dB below maximum output.
Frequency range 125 Hz to 8 kHz
Speech Frequency response Frequency Linear FFequv.
(Hz) (dB) (dB)
Ext sign Int. Sign Ext sign Int. Sign
DD45 125-250 +0/-2 +1/-0 +0/- +0/-7
(IEC 60318-3 Coupler) 250-4000 +1/-1 +1/-1 +2/-2 +2/-3
4000-6300 +0/-2 +0/-2 +1/-1 +1/-1
DD450 125-250 +0/-2 +1/-0 +0/- +0/-7
(IEC 60318-1 Coupler) 250-4000 +1/-1 +1/-1 +2/-2 +2/-3
4000-6300 +0/-2 +0/-2 +1/-1 +1/-1
DD65v2 125-250 +0/-2 +1/-0 +0/- +0/-7
(IEC 60645-1 Coupler) 250-4000 +1/-1 +1/-1 +2/-2 +2/-3
4000-6300 +0/-2 +0/-2 +1/-1 +1/-1
IP 30 250-4000 +2/-3 +4/-1 (Non-linear)
(IEC 60318-5 Coupler)
B71 Conductor 250-4000 +12/-12 +12/-12 (Non-linear)
(IEC 60318-6 Coupler)
2% THD at 1000 Hz max output +9 dB (increasing at lower frequency)
Level range: -10 to 50 dB HL, overall THD <6%

1. Ext. sign: CD input 2. Int. sign: Wave files

External signal Speech replaying equipment connected to the aux input must have a signal-to-noise
ratio of 45 dB or higher.
The speech material used must include a calibration signal suitable for adjusting the
input to 0 dB VU.
Microphone The microphone of the MTH400m is used for live speech. Microphone gain must be
(Live speech) adjusted to 0 VU prior to use.

D-0121388-B – 2020/05
AD528 – Technical Specifications Page 3
Free field Power amplifier and loudspeakers
With an input of 7 Vrms - Amplifier and loudspeakers must be able to create a Sound
Pressure Level of 100 dB in a distance of 1 meter - and meet the following
requirements:
Frequency Response Total Harmonic Distortion
125-250 Hz +0/-10 80 dB SPL < 3%
dB
250-4000 ±3 dB 100 dB SPL < 10%
Hz
4000-6300 ±5 dB
Hz
Internal storage 50.000 sessions (500 clients, 100 sessions/client)
Signal Indicator Time weighting: 300 mS
(VU) Dynamic range: 23 dB
Rectifier characteristics: RMS
Selectable inputs are provide with an attenuator by which the level can be adjusted to
the indicator reference position (0 dB).

D-0121388-B – 2020/05
AD528 – Technical Specifications Page 4

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