Ambient Conditions:

Power supply:

230 Volt ± 10%

Power frequency:

50 Hz ± 5 %

Temperature range:

+15 ºC to +35 ºC ; 59 ºF to 95 ºF

Temperatures over 40 ºC (104 ºF) may damage the system.

Relative humidity:

30% bis 90%

Warm-up period:

1 minute

Magnetic fields:

Maximum 60 A/m

High-frequency fields:

Maximum 10 V/m 100 kHz bis 500 mHz

Maximum  1 V/m 500 mHz bis 1 gHz

When exposed to strong electromagnetic fields, it may cause an impairment of handling or even a complete malfunction of ACAM.

Physical dimensions:

Control unit:

360 x 365 x 140 mm (L x B x H)

Open test box, small:    

200 x 200 x 120 mm (L x B x H)

Closed test box, large:

400 x 330 x 300 mm (L x B x H)

Weight:

Control unit:

Open test box, small: 

Closed test box, large:

Input sensivity:

Microphone input, test box:        

10 kOhm at 1kHz

Microphone input, in-situ:

1 kOhm at 1kHz

Microphone sensitivity (Test box and Insitu):

1 mV/bar 10 mV/Pa +/- 2,5 dB

Battery tester:

> 1 mOhm

External inputs 1 to 4:

10 kOhm at 1kHz

Microphone talk-forward and talk-back:

10 kOhm at 1 kHz

Output Impedances:

Headphones:

6 ohm

Bone conduction:

4 ohm

Loudspeakers:

4 ohm

Open headphones (K1000):

120 ohm

Insert headphones:

10 ohm

General data:

The audiometer meets EN 60645 – 1:2002  and EN 60645 – 2:1997; ANSI S3.6. Procedures and processes according to DIN ISO 8253 – 1:1992 , DIN ISO 8253 – 2:1994, and DIN ISO 8253 – 3:1998 are applicable or integrated.

The loudness scaling meets DIN ISO 16832:2003.

Measurements with the test box meets DIN EN 60118-0:1994 (with connected ear simulator), DIN EN 118-1:1999, DIN EN 118-2:1998, DIN EN 60118-7:2006, DIN EN 60118-15:2009, and ANSI S3.22.

The insitu measurement meet the DIN EN 61669:2002. Procedures, designations and processes meet DIN ISO 12124:2002 and ANSI S3.46.

The system fulfils the Medical Device Rule RL 93/42/EEC type IIb. A Quality system following the standard EN 13485 is implemented and approved with the CE sign and notified boy with the number 0482.

The safety rules of EN 60601-1 Class 1, type B, 60601-1-1, and 60601-1-2 are fulfilled.

What is with:  USA UL 2601-1, CAN/CSA-C22.2 No. 601.1-M90,

Audiometer class:

Class 2 Type AE (Level: class 1) according to EN 60645-1, EN 60645-2, and ANSI S3.6.

Maintenance and Calibration:

According to EN 8253-1.

Step A: After 80 startup routines, or after 30 days.

Step B: Once a year.

Headphones:

Beyer Dynamik, type: DT 48 A        Required pressure force: 4,5 N ± 0,5 N

Bone conduction oscillator:

Radioear type: B 71.                  Required pressure force: 5,4 N ± 0,5 N

Loudspeaker:

Tannoy, type: i5 AW.

Insertion headphones:

Etymotic Research, type: ER 3 A.

Open headphone:

AKG, type: K1000

Test box:

Input level range:

20 dB - 100 dB (Ref. 20 µPa).

Accuracy of input level:

Better than 1.5dB up to 2kHz and better than 2.5dB from 2 kHz – 5 kHz.

Frequency range:

100 Hz - 10000 Hz.

Measurement range:

<30 dB - >140 dB (Ref. 20 µPa).

Accuracy of measurement:

1 dB up to 2 kHz ; 1.5dB from 2 kHz – 5 kHz

Induction:

Field intensity < 0.1 mA/m bis >1 A/m.

Operating current:

0.01mA bis 20mA +/- 0.01mA

Betriebsspannung:

0.6 Volt to 3 Volt in steps of 0.01Volt, Accuracy: 0.01Volt

Battery test:

Measurement range: 0 Volt to 1.5 Volt. Accuracy 0.01 Volt.

Load resistances electively from 100 Ohm to 2 kOhm (Accuracy 10%)

Kuppler:

2ccm according. to IEC 126.

Ear simulator according. to IEC 711 retrofittable.

SES (simulated ear simulator) retrofittable.

Calibration:

See Calibration chapter

Measuring signals:

Sinusoidal tone with 226 Frequency (including frequencies according to ISO 266), third, white noise, pink noise, speech simulating noise, ICRA, burst, CHIRP, speech, ISTS, natural sounds, and external supply.

Analysis:

RMS (time weighting 1 ms to >1 Min), FFT, Percentile analysis (according to IEC 118-15), Group delay time, static and dynamic CR, waterfall display, sonogram, spectra,         level progress, level distribution, envelope array, roughness, acuity, loudness, reverberation time.

Real Ear Measurement:

Input level range:

30 dB - 100 dB (Ref. 20 µPa).

Accuracy of input level:

Better than 1.5 dB up to 2kHz better then 2.5 dB from 2 kHz – 5 kHz*.

Frequency range:

100 Hz – 10,000 Hz.

Measurement range:                

<30 dB - >140 dB (Ref. 20 µPa).

Accuracy of measurement:

1 dB up to 2 kHz*; 1,5dB from 2 kHz – 5 kHz*.

Equalization:

With adjustable FIR fIlter .

Calibration:

See Calibration Chapter.

Measuring signals:

Sinusoidal tone with 226 Frequency (including frequencies according to ISO 266),

white noise, ICRA noise, CHIRP, speech, ISTS, natural sounds, external supply.

Analysis:

RMS, FFT, percentile analysis (according to IEC 118-15).

*These values depend on the ambient conditions. The values stated above were determined under ideal conditions.

Tone audiometer:

Calibrations:

Air condition:

EN 389-1 with coupler according to EN 60318-1.

Bone condition:

EN 389-3 with coupler according to DIN IEC 373. Calibration applies for attachment on mastoid.

Loudspeaker:

EN 389-7 with sound level meter class 1 in 1 m distance.

Insertion earphones:

EN 389-2 with coupler according. to 60218-5.

Masking noise:

EN 389-4 with coupler according to EN 60318-1 and sound level meter class 1.

Specifications:

Masking noise:

Narrowband noise 1/3 octave with > 24 dB/octave.

Type of modulation of pure tone:

Frequency modulation (FM).

Type of modulation (FM):

Sinusoidal (distortion <1%).

Modulation frequency (FM):

1.1 Hz to 66 Hz +/- 10 %.

Modulation stroke (FM):

0.1 % to 100 % +/- 1%.

Chart 1  : Sound reduction factor of the used headphones.

Chart 2 : Adjustable maximum levels of headphones.

Chart 3 : Adjustable maximum levels of headphones, whereby a distortion factor of 2.5% is not exceeded.

Chart 4 : Adjustable maximum levels of bone conduction oscillator.

Chart 5: Adjustable maximum levels of bone conduction oscilattor,whereby a distortion factor of 5.5% is not exceeded.

Chart 6: Effective bandwidth of masking noises.

When measuring via bone conduction, the bone conductor also emits airborne sound. This may falsify the measurement.

Chart 7 : Part of airborne sound of the bone conductor.

Speech audiometer:

General data:

Headphones, bone conduction oscillator, insertion earphones, and open headphones are free-field equalized. All level values refer to free-field according to nach EN 60645-2.

Masking noise:        

According to EN 60645-2.

Allowed speech test material: 

According to EN 8253-3.

Maximum level:

Headphones:

130dB; Distortion: 0.81% at 120dB, 0.89%.

Free-field:

100dB; Distortion:14.9% at 90dB, 6.0%.

Bone conduction earphones:

80 dB; Distortion: 11.2% at 70dB, 3.0%.

Insertion earphones:        

130dB; Distortion: 2.35% at 120dB, 0.6%.

Open headphones:

100 dB; Distortion:1.67% at 90dB, 0.95%.

Calibration:

Level adjustment for speech signal:

In dB SPL (Ref. 20 µPa).

Level adjustment for noise:

In dB SPL (Ref. 20 µPa).

Only use speech test material with calibration noises. This ensures a correct reproduction of sound levels and the comparability stated in the standards. See also: CD Playback – Calibration.

Chart 8: Difference between the free-field sensitivity level and the coupler sensitivity level for the used headphones at coupler according to IEC 60318-3 for third octave band noise (Free-field equalization of headphone).

Chart 9: Difference between the free-field sensitivity level and the coupler sensitivity level for the used bone-conduction oscillator at coupler according to IEC 373 for third octave band noise (Free-field equalization of bone-conduction oscillator).

Loudnes Scaling:

Level range:

0-100 dB via open headphone.

0-90 dB via loudspeakers.

40-140 dB via insertion earphones.

Calibration:

In dB SPL (Ref. 20 µPa).

Free-field equalization:

Yes.

Level increment: 

1 dB (according to EN 60645-1).

Signals:

Third-octave noise (1/3 Oktave) >48 dB /Octave slew.

Response input:

Manually via mouse or touch screen.

Reference curve:

According to mass screening of ProfessorHeller „Lorenz Function.“

Error correction:

Yes (based on a mathematic function).

Generation of individual function:

Lorenz Function.

Status:

Normally there is nothing to plugin. This plugin is used to monitoring the supply voltages and the internal bus system.

On the left side of the plugin are connectors to measure the voltages of the system. They are used only for service.

Interrupter:

The interrupter plugin is a part of the audiometer.

Audiometer:

The audiometer plugin is a part of the audiometer.

Amplifier 3

Amplifier no 3 to be used for several loudspeakers.

To ansure that the loudspeakers are simular to the software we strongy recommend to conect the speakers as shown inthe table below (from the perspective of the patient).

Amplifier 2

Amplifier no 2 to be used for several loudspeakers.

To ansure that the loudspeakers are simular to the software we strongy recommend to conect the speakers as shown inthe table below (from the perspective of the patient).

Amplifier 1

Amplifier no 1 to be used for several loudspeakers.

To ansure that the loudspeakers are simular to the software we strongy recommend to conect the speakers as shown inthe table below (from the perspective of the patient).

Codec 2

This plugin holds the codec (several intelligent AD and DA vonverter) number 2 and the needed input electronic.

Codec 1

This plugin holds the codec (several intelligent AD and DA vonverter) number 1 and the needed input electronic.

Controller

This plug in holds the processors.