Affinity Instructions for Use Part 2 Nov 2014

2

Affinity Instrucções para a utilização - PT

Page 36

Technical Specifications of the AC440 Software Medical CE-mark:

Audiometer Standards: Transducers & Calibration:

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. Tone: IEC60645-1/ANSI S3.6 Type 1 Speech: IEC60645-2/ANSI S3.6 Type A or A-E 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 10N 0.5N

HDA280

PTB report 2004

Headband Static Force 5N 0.5N

E.A.R Tone 3A/5A

ISO 389-2 1994, ANSI S3.6-2010

CIR 33

ISO 389-2

Bone Conduction

Placemenet: Mastoid

B71

ISO 389-3 1994, ANSI S3.6-2010

Free Field

ISO 389-7 2005, ANSI S3.6-2010

High Freqency

ISO 389-5 2004, ANSI S3.6-2010

Effective masking

ISO 389-4 1994, ANSI S3.6-2010

Headband Static Force 5.4N 0.5N

Patient Response switch:

Hand held push button.

Patient communication:

Talk Forward and Talk Back.

Monitor:

Output through external earphone or speaker.

Stimuli:

Tom puro, Tom oscilante, NB, SN, WN, Ruído TEN

Warble Tone

125-20000Hz separated in two ranges 125-8000Hz and 8000-20000Hz. Resolution 1/2-1/24 octave. 1-10 Hz sine +/- 5% modulation

Wave file

44100Hz sampling, 16 bits, 2 channels

Masking

White noise:

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

Speech Noise.

IEC 60645-2:1993 125-6000Hz falling 12dB/octave above 1KHz +/-5dB

Presentation

Manual or Reverse. Single or multiple pulses. pulse time adjustable from 200mS-5000mS in 50mS steps. Simultaneous or alternating.

Intensity

Check the accompanying Appendix for maximum output levels

Steps

Available Intensity Steps is 1, 2 or 5dB

Accuracy

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.

Tone

Narrow band noise:

Extended range function Frequency Distortion (THD) Signal Indicator(VU)

Storing capability:

Compatible Software:

Range: 125Hz to 8kHz (Optional High Freqency: 8 kHz to 20 kHz) Accuracy: Better than ± 1 % Sound pressure levels: below 1.5 % Vibration force levels: below 3 %. 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) Audiograma de tom: dB HL, MCL, UCL, Tinnitus, R+L Audiograma de discurso (fala): WR1, WR2, WR3, MCL, UCL, Assistido, Não assistido, Binauricular, R+L. Noah4, Noah 3.7, OtoAccessTM and XML compatible

2.0

Affinity

Kasutusjuhend - ET

4. Valige „Install the software automatically (Recommended)“ (Installi tarkvara automaatselt (soovitatav)).

5. Klõpsake „Next“ (Edasi) ja oodake tarkvara installimist.

Page 19

5.1 Survey of reference and max hearing level Tone Audiometer. ANSI TDH39 Coupler: ANSI S3.7-1995 (NBS-9A) / IEC 60318-3 1998 (6ccm) Tone Audiometer Tone Narrow Band Noise ANSI S3.6-2010 ANSI S3.6-2010 Frequency RETSPL MaxHL RETSPL MaxHL 125 45.0 90 49.0 75 160¹ 37.5 95 41.5 85 200¹ 31.5 100 35.5 90 250 25.5 110 29.5 95 315¹ 20.0 115 24.0 100 400¹ 15.0 120 19.0 105 500 11.5 120 15.5 110 630¹ 8.5 120 13.5 110 750 8.0 120 13.0 110 800¹ 7.0 120 12.0 110 1000 7.0 120 13.0 110 1250¹ 6.5 120 12.5 110 1500 6.5 120 12.5 110 1600¹ 7.0 120 13.0 110 2000 9.0 120 15.0 110 2500¹ 9.5 120 15.5 110 3000 10.0 120 16.0 110 3150¹ 10.0 120 16.0 110 4000 9.5 120 14.5 110 5000¹ 13.0 120 18.0 110 6000 15.5 120 20.5 110 6300¹ 15.0 120 20.0 110 8000 13.0 110 18.0 100 WhiteNoise 0.0 120 TenNoise 25.0 110 ¹ The RETSPL is copy from ISO389-1 1998

ANSI HDA 280 Coupler ANSI S3.7-1995 (NBS-9A) / IEC 60318-3 1998 (6ccm) Tone Audiometer Tone Narrow Band Noise PTB PTB Frequency RETSPL MaxHL RETSPL MaxHL 125 38.5 105 42.5 75 160¹ 33.5 110 37.5 80 200¹ 29.5 115 33.5 85 250 25.0 120 29.0 90 315¹ 21.0 120 25.0 95 400¹ 17.0 120 21.0 95 500 13.0 120 17.0 100 630¹ 10.5 120 15.5 100 750 9.0 120 14.0 105 800¹ 8.5 120 13.5 105 1000 7.5 120 13.5 105 1250¹ 8.5 120 14.5 105 1500 9.5 120 15.5 105 1600¹ 9.0 120 15.0 105 2000 8.0 120 14.0 105 2500¹ 7.0 120 13.0 105 3000 6.5 120 12.5 105 3150¹ 7.0 120 13.0 105 4000 9.5 120 14.5 105 5000¹ 12.0 120 17.0 105 6000 19.0 115 24.0 95 6300¹ 19.0 115 24.0 95 8000 18.0 105 23.0 90 WhiteNoise 0.0 120 ¹ This value is interpolated on Interacoustics

IEC TDH39 Coupler: IEC 60318-3 1998 (6ccm)

Frequency 125 160 200 250 315 400 500 630 750 800 1000 1250 1500 1600 2000 2500 3000 3150 4000 5000 6000 6300 8000 WhiteNoise TenNoise

Tone Audiometer Tone Narrow Band Noise ISO 389-1 1998 ISO 389-4 1994 RETSPL MaxHL RETSPL MaxHL 45.0 90 49.0 75 37.5 95 41.5 85 31.5 100 35.5 90 25.5 110 29.5 95 20.0 115 24.0 100 15.0 120 19.0 105 11.5 120 15.5 110 8.5 120 13.5 110 7.5 120 12.5 110 7.0 120 12.0 110 7.0 120 13.0 110 6.5 120 12.5 110 6.5 120 12.5 110 7.0 120 13.0 110 9.0 120 15.0 110 9.5 120 15.5 110 10.0 120 16.0 110 10.0 120 16.0 110 9.5 120 14.5 110 13.0 120 18.0 110 15.5 120 20.5 110 15.0 120 20.0 110 13.0 110 18.0 100 0.0 120 25.0 110

IEC HDA 280 Coupler IEC 60318-3 1998 (6ccm) Tone Audiometer Tone Narrow Band Noise PTB ISO 389-4 1994 Frequency RETSPL MaxHL RETSPL MaxHL 125 38.5 105 42.5 75 160¹ 33.5 110 37.5 80 200¹ 29.5 115 33.5 85 250 25.0 120 29.0 90 315¹ 21.0 120 25.0 95 400¹ 17.0 120 21.0 95 500 13.0 120 17.0 100 630¹ 10.5 120 15.5 100 750 9.0 120 14.0 105 800¹ 8.5 120 13.5 105 1000 7.5 120 13.5 105 1250¹ 8.5 120 14.5 105 1500 9.5 120 15.5 105 1600¹ 9.0 120 15.0 105 2000 8.0 120 14.0 105 2500¹ 7.0 120 13.0 105 3000 6.5 120 12.5 105 3150¹ 7.0 120 13.0 105 4000 9.5 120 14.5 105 5000¹ 12.0 120 17.0 105 6000 19.0 115 24.0 95 6300¹ 19.0 115 24.0 95 8000 18.0 105 23.0 90 WhiteNoise 0.0 120 ¹ This value is interpolated on Interacoustics

ANSI HDA 200 Coupler: IEC60318-2 with type 1 adaptor Tone Audiometer Tone Narrow Band Noise ANSI S3.6-2010 ANSI S3.6-2010 Frequency RETSPL MaxHL RETSPL 1/3 MaxHL 125 30.5 100 34.5 75 160¹ 26.0 105 30.0 80 200¹ 22.0 105 26.0 80 250 18.0 110 22.0 85 315¹ 15.5 115 19.5 90 400¹ 13.5 115 17.5 95 500 11.0 115 15.0 95 630¹ 8.0 120 13.0 95 750 6.0 120 11.0 100 800¹ 6.0 120 11.0 100 1000 5.5 120 11.5 100 1250¹ 6.0 110 12.0 95 1500 5.5 115 11.5 100 1600¹ 5.5 115 11.5 100 2000 4.5 115 10.5 100 2500¹ 3.0 115 9.0 100 3000 2.5 115 8.5 100 3150¹ 4.0 115 10.0 100 4000 9.5 115 14.5 100 5000¹ 14.0 105 19.0 95 6000 17.0 105 22.0 90 6300¹ 17.5 105 22.5 90 8000 17.5 105 22.5 90 9000 19.0 100 24.0 85 10000 22.0 100 27.0 85 11200 23.0 95 28.0 80 12500 27.5 90 32.5 75 14000 35.0 80 40.0 70 16000 56.0 60 61.0 50 18000² 72.0 40 77.0 25 20000² 86.0 25 91.0 10 WhiteNoise 0.0 115 ¹ The RETSPL is copy from ISO389-8 2001. ² 18-20 kHz is estimated of Interacoustics.

ANSI EAR 3A Coupler: ANSI S3.7-1995 (HA-2 with 5mm rigid Tube) Tone Audiometer Narrow Band Tone Noise ANSI S3.6-2010 ANSI S3.6-2010 Frequency RETSPL MaxHL RETSPL MaxHL 125 26.0 90 30.0 90 160 22.0 95 26.0 95 200 18.0 100 22.0 100 250 14.0 105 18.0 105 315 12.0 105 16.0 105 400 9.0 110 13.0 105 500 5.5 110 9.5 110 630 4.0 115 9.0 110 750 2.0 115 7.0 110 800 1.5 115 6.5 110 1000 0.0 120 6.0 110 1250 2.0 120 8.0 110 1500 2.0 120 8.0 110 1600 2.0 120 8.0 110 2000 3.0 120 9.0 110 2500 5.0 120 11.0 110 3000 3.5 120 9.5 110 3150 4.0 120 10.0 110 4000 5.5 115 10.5 110 5000 5.0 105 10.0 105 6000 2.0 100 7.0 100 6300 2.0 100 7.0 100 8000 0.0 95 5.0 95 WhiteNoise 0.0 110

IEC HDA 200 Coupler: IEC60318-1 with type 1 adaptor Tone Audiometer Tone Narrow Band Noise ISO 389-8 2004 ISO 389-4 1994 Frequency RETSPL MaxHL RETSPL 1/3 MaxHL 125 30.5 100 34.5 75 160 26.0 105 30.0 80 200 22.0 105 26.0 80 250 18.0 110 22.0 85 315 15.5 115 19.5 90 400 13.5 115 17.5 95 500 11.0 115 15.0 95 630 8.0 120 13.0 95 750 6.0 120 11.0 100 800 6.0 120 11.0 100 1000 5.5 120 11.5 100 1250 6.0 110 12.0 95 1500 5.5 115 11.5 100 1600 5.5 115 11.5 100 2000 4.5 115 10.5 100 2500 3.0 115 9.0 100 3000 2.5 115 8.5 100 3150 4.0 115 10.0 100 4000 9.5 115 14.5 100 5000 14.0 105 19.0 95 6000 17.0 105 22.0 95 6300 17.5 105 22.5 95 8000 17.5 105 22.5 90 ISO 389-5 2006 ISO 389-5 2006 + 5 dB 8000 17.5 105 22.5 90 9000 19.0 100 24.0 85 10000 22.0 100 27.0 85 11200 23.0 95 28.0 80 12500 27.5 90 32.5 75 14000 35.0 80 40.0 70 16000 56.0 60 61.0 50 18000² 72.0 40 77.0 25 20000² 86.0 25 91.0 10 WhiteNoise 0.0 115 ² 18-20 kHz is estimated of Interacoustics.

Frequency

WhiteNoise

IEC EAR 3A Coupler: IEC 60318-5 2006 2ccm Tone Audiometer Tone Narrow Band Noise ISO 389-2 1994 ISO 389-4 1994 RETSP L MaxHL RETSPL MaxHL 125 26.0 90 30.0 90 160 22.0 95 26.0 95 200 18.0 100 22.0 100 250 14.0 105 18.0 105 315 12.0 105 16.0 105 400 9.0 110 13.0 105 500 5.5 110 9.5 110 630 4.0 115 9.0 110 750 2.0 115 7.0 110 800 1.5 115 6.5 110 1000 0.0 120 6.0 110 1250 2.0 120 8.0 110 1500 2.0 120 8.0 110 1600 2.0 120 8.0 110 2000 3.0 120 9.0 110 2500 5.0 120 11.0 110 3000 3.5 120 9.5 110 3150 4.0 120 10.0 110 4000 5.5 115 10.5 110 5000 5.0 105 10.0 105 6000 2.0 100 7.0 100 6300 2.0 100 7.0 100 8000 0.0 95 5.0 95 0.0 110

ANSI Ear 5A Coupler ANSI S3.7-1995 (HA-2 with 5mm rigid Tube) Tone Audiometer Tone Narrow Band Noise ANSI S3.6-2010 ANSI S3.6-2010 Frequency RETSPL MaxHL RETSPL MaxHL 125 26.0 95 30.0 85 160 22.0 95 26.0 90 200 18.0 100 22.0 95 250 14.0 100 18.0 100 315 12.0 105 16.0 100 400 9.0 105 13.0 105 500 5.5 110 9.5 110 630 4.0 115 9.0 110 750 2.0 120 7.0 110 800 1.5 120 6.5 110 1000 0.0 120 6.0 110 1250 2.0 120 8.0 110 1500 2.0 120 8.0 110 1600 2.0 120 8.0 110 2000 3.0 120 9.0 110 2500 5.0 120 11.0 110 3000 3.5 120 9.5 110 3150 4.0 120 10.0 110 4000 5.5 120 10.5 110 5000 5.0 110 10.0 110 6000 2.0 105 7.0 105 6300 2.0 105 7.0 105 8000 0.0 100 5.0 100 WhiteNoise 0.0 110

IEC Ear 5A Coupler IEC 60318-5 2006 2ccm Tone Audiometer Tone Narrow Band Noise ISO 389-2 1994 ISO 389-4 1994 Frequency RETSPL MaxHL RETSPL MaxHL 125 26.0 95 30.0 85 160 22.0 95 26.0 90 200 18.0 100 22.0 95 250 14.0 100 18.0 100 315 12.0 105 16.0 100 400 9.0 105 13.0 105 500 5.5 110 9.5 110 630 4.0 115 9.0 110 750 2.0 120 7.0 110 800 1.5 120 6.5 110 1000 0.0 120 6.0 110 1250 2.0 120 8.0 110 1500 2.0 120 8.0 110 1600 2.0 120 8.0 110 2000 3.0 120 9.0 110 2500 5.0 120 11.0 110 3000 3.5 120 9.5 110 3150 4.0 120 10.0 110 4000 5.5 120 10.5 110 5000 5.0 110 10.0 110 6000 2.0 105 7.0 105 6300 2.0 105 7.0 105 8000 0.0 100 5.0 100 WhiteNoise 0.0 110

ANSI CIR 22/CIR 33 Coupler ANSI S3.7-1995 (HA-2) Tone Audiometer Tone Narrow Band Noise ANSI S3.6-2010 ANSI S3.6-2010 Frequency RETSPL MaxHL RETSPL MaxHL 125 26.0 90 30.0 90 160 22.0 95 26.0 95 200 18.0 100 22.0 100 250 14.0 105 18.0 105 315 12.0 105 16.0 105 400 9.0 110 13.0 105 500 5.5 110 9.5 110 630 4.0 115 9.0 110 750 2.0 115 7.0 110 800 1.5 115 6.5 110 1000 0.0 120 6.0 110 1250 2.0 120 8.0 110 1500 2.0 120 8.0 110 1600 2.0 120 8.0 110 2000 3.0 120 9.0 110 2500 5.0 120 11.0 110 3000 3.5 120 9.5 110 3150 4.0 120 10.0 110 4000 5.5 115 10.5 105 5000 5.0 105 10.0 95 6000 2.0 100 7.0 95 6300 2.0 100 7.0 95 8000 0.0 90 5.0 90 WhiteNoise 0.0 110

IEC CIR 22/CIR 33 Coupler IEC 60318-5 2006 2ccm Tone Audiometer Tone Narrow Band Noise ISO 389-2 1994 ISO 389-4 1994 Frequency RETSPL MaxHL RETSPL MaxHL 125 26.0 90 30.0 90 160 22.0 95 26.0 95 200 18.0 100 22.0 100 250 14.0 105 18.0 105 315 12.0 105 16.0 105 400 9.0 110 13.0 105 500 5.5 110 9.5 110 630 4.0 115 9.0 110 750 2.0 115 7.0 110 800 1.5 115 6.5 110 1000 0.0 120 6.0 110 1250 2.0 120 8.0 110 1500 2.0 120 8.0 110 1600 2.0 120 8.0 110 2000 3.0 120 9.0 110 2500 5.0 120 11.0 110 3000 3.5 120 9.5 110 3150 4.0 120 10.0 110 4000 5.5 115 10.5 105 5000 5.0 105 10.0 95 6000 2.0 100 7.0 95 6300 2.0 100 7.0 95 8000 0.0 90 5.0 90 WhiteNoise 0.0 110

ANSI B71

Frequency 125 160 200 250 315 400 500 630 750 800 1000 1250 1500 1600 2000 2500 3000 3150 4000 5000 6000 6300 8000 WhiteNoise

Coupler ANSI S3.13 Tone Audiometer Tone Narrow Band Noise ANSI S3.6 -2010 ANSI S3.6 - 2010 RETSPL MaxHL RETSPL MaxHL 67.0 45 71.0 35 64.0 50 68.0 40 61.0 65 65.0 55 58.0 65 62.0 55 52.5 70 57.5 60 48.5 70 53.5 60 47.0 70 52.0 60 42.5 70 48.5 60 39.0 70 45.0 60 36.5 70 42.5 60 35.5 70 41.5 60 31.0 75 37.0 65 29.5 80 35.5 70 30.0 80 36.0 70 31.0 80 37.0 70 35.5 80 40.5 70 40.0 60 45.0 50 40.0 50 45.0 45 40.0 50 45.0 40 40.0 50 45.0 40 42.5 70

Frequency 125 160 200 250 315 400 500 630 750 800 1000 1250 1500 1600 2000 2500 3000 3150 4000 5000 6000 6300 8000 WhiteNoise

IEC B71 Coupler 60318-6 2007 Tone Audiometer Tone Narrow Band Noise ISO 389-3 1994 ISO 389-4 1994 RETSPL MaxHL RETSPL MaxHL 67.0 45 71.0 35 64.0 50 68.0 40 61.0 65 65.0 55 58.0 65 62.0 55 52.5 70 57.5 60 48.5 70 53.5 60 47.0 70 52.0 60 42.5 70 48.5 60 39.0 70 45.0 60 36.5 70 42.5 60 35.5 70 41.5 60 31.0 75 37.0 65 29.5 80 35.5 70 30.0 80 36.0 70 31.0 80 37.0 70 35.5 80 40.5 70 40.0 60 45.0 50 40.0 50 45.0 45 40.0 50 45.0 40 40.0 50 45.0 40 42.5 70

ANSI DD45 Coupler: IEC 60318-3 1998 (6ccm)

IEC DD45 Coupler: IEC 60318-3 1998 (6ccm)

Tone Audiometer Tone Narrow Band Noise PTB – DTU 2010 ISO 389-4 1994 Frequency RETSPL MaxHL RETSPL MaxHL 125 47.5 90 51.5 75 160¹ 40.5 95 44.5 85 200¹ 33.5 100 37.5 90 250 27.0 110 31.0 95 315¹ 22.5 115 26.5 100 400¹ 17.5 120 21.5 105 500 13.0 120 17.0 110 630¹ 9.0 120 14.0 110 750 6.5 120 11.5 110 800¹ 6.5 120 11.5 110 1000 6.0 120 12.0 110 1250¹ 7.0 120 13.0 110 1500 8.0 120 14.0 110 1600¹ 8.0 120 14.0 110 2000 8.0 120 14.0 110 2500¹ 8.0 120 14.0 110 3000 8.0 120 14.0 110 3150¹ 8.0 120 14.0 110 4000 9.0 120 14.0 110 5000² 10.0 120 15.0 110 6000 20.5 115 25.5 105 6300¹ 19.0 115 24.0 105 8000 12.0 110 17.0 100 WhiteNoise 0 120 ¹ This value is interpolated on Interacoustics ² Only PTB value

Tone Audiometer Tone Narrow Band Noise PTB – DTU 2010 ISO 389-4 1994 Frequency RETSPL MaxHL RETSPL MaxHL 125 47.5 90 51.5 75 160¹ 40.5 95 44.5 85 200¹ 33.5 100 37.5 90 250 27.0 110 31.0 95 315¹ 22.5 115 26.5 100 400¹ 17.5 120 21.5 105 500 13.0 120 17.0 110 630¹ 9.0 120 14.0 110 750 6.5 120 11.5 110 800¹ 6.5 120 11.5 110 1000 6.0 120 12.0 110 1250¹ 7.0 120 13.0 110 1500 8.0 120 14.0 110 1600¹ 8.0 120 14.0 110 2000 8.0 120 14.0 110 2500¹ 8.0 120 14.0 110 3000 8.0 120 14.0 110 3150¹ 8.0 120 14.0 110 4000 9.0 120 14.0 110 5000² 10.0 120 15.0 110 6000 20.5 115 25.5 105 6300¹ 19.0 115 24.0 105 8000 12.0 110 17.0 100 WhiteNoise 0 120 ¹ This value is interpolated on Interacoustics ² Only PTB value

Frequency 8000 9000 10000 11200 12500 14000 16000 18000 20000 White Noise

ANSI KOSS R80 Coupler: IEC 60318-1 1998

IEC KOSS R80 Coupler: IEC 60318-1 1998

HF Tone Audiometer Tone Narrow Band Noise IA - value ISO 389-4 1994 RETSPL MaxHL RETSPL MaxHL 18.5 100 23.5 90 20.5 90 25.5 85 24.5 95 29.5 80 22.0 95 27.0 80 27.0 80 32.0 75 37.0 75 42.0 60 52.5 60 57.5 45 70.0 40 75.0 20 84.0 15 89.0 10 0 110

HF Tone Audiometer Tone Narrow Band Noise IA - value ISO 389-4 1994 RETSPL MaxHL RETSPL MaxHL 18.5 100 23.5 90 20.5 90 25.5 85 24.5 95 29.5 80 22.0 95 27.0 80 27.0 80 32.0 75 37.0 75 42.0 60 52.5 60 57.5 45 70.0 40 75.0 20 84.0 15 89.0 10 0 110

Frequency 8000 9000 10000 11200 12500 14000 16000 18000 20000 White Noise

ANSI

Frequency 125 160 200 250 315 400 500 630 750 800 1000 1250 1500 1600 2000 2500 3000 3150 4000 5000 6000 6300 8000 WhiteNoise

IEC

ANSI Free Field

0° RETSPL 22.0 18.0 14.5 11.5 8.5 6.0 4.5 3.0 2.5 2.0 2.5 3.5 2.5 1.5 -1.5 -4.0 -6.0 -6.0 -5.5 -1.5 4.5 6.0 12.5 0.0

ANSI S3.6-2010 Binaural Monaural 45° 90° 0° 45° 90° RETSPL RETSPL RETSPL RETSPL RETSPL 21.5 21.0 24.0 23.5 23.0 17.0 16.5 20.0 19.0 18.5 13.5 13.0 16.5 15.5 15.0 10.5 9.5 13.5 12.5 11.5 7.0 6.0 10.5 9.0 8.0 3.5 2.5 8.0 5.5 4.5 1.5 0.0 6.5 3.5 2.0 -0.5 -2.0 5.0 1.5 0.0 -1.0 -2.5 4.5 1.0 -0.5 -1.5 -3.0 4.0 0.5 -1.0 -1.5 -3.0 4.5 0.5 -1.0 -0.5 -2.5 5.5 1.5 -0.5 -1.0 -2.5 4.5 1.0 -0.5 -2.0 -3.0 3.5 0.0 -1.0 -4.5 -3.5 0.5 -2.5 -1.5 -7.5 -6.0 -2.0 -5.5 -4.0 -11.0 -8.5 -4.0 -9.0 -6.5 -11.0 -8.0 -4.0 -9.0 -6.0 -9.5 -5.0 -3.5 -7.5 -3.0 -7.5 -5.5 0.5 -5.5 -3.5 -3.0 -5.0 6.5 -1.0 -3.0 -1.5 -4.0 8.0 0.5 -2.0 7.0 4.0 14.5 9.0 6.0 0.0 0.0 0.0 0.0 0.0

IEC

Free Field max SPL Free Field max HL is found by subtracting the selected RETSPL value Free Field Power Free Field Line Free Field Speaker Tone NB Tone NB Tone NB Max SPL Max SPL Max SPL Max SPL Max SPL Max SPL 95 85 100 95 80 70 95 85 100 95 80 70 95 85 105 100 85 75 95 85 105 100 85 75 95 85 105 100 85 75 95 85 105 100 90 80 95 85 105 100 90 80 95 85 105 100 90 80 95 85 105 100 90 80 95 85 105 100 90 80 95 85 105 100 90 80 95 85 105 100 90 80 95 85 105 100 90 80 95 85 105 100 90 80 95 85 105 100 90 80 95 85 100 95 90 80 95 85 105 95 90 80 95 85 105 95 90 80 95 85 105 100 90 80 95 85 110 100 90 80 95 85 105 100 90 80 95 85 105 95 90 80 90 75 95 90 90 80 90 100 85

Free Field

ISO 389-7 2005 Free Field Power Free Field Power Tone Tone Tone Tone Tone Tone Frequency RETSPL RETSPL RETSPL RETSPL RETSPL RETSPL 125 22.0 21.5 21.0 24.0 23.5 23.0 160 18.0 17.0 16.5 20.0 19.0 18.5 200 14.5 13.5 13.0 16.5 15.5 15.0 250 11.5 10.5 9.5 13.5 12.5 11.5 315 8.5 7.0 6.0 10.5 9.0 8.0 400 6.0 3.5 2.5 8.0 5.5 4.5 500 4.5 1.5 0.0 6.5 3.5 2.0 630 3.0 -0.5 -2.0 5.0 1.5 0.0 750 2.5 -1.0 -2.5 4.5 1.0 -0.5 800 2.0 -1.5 -3.0 4.0 0.5 -1.0 1000 2.5 -1.5 -3.0 4.5 0.5 -1.0 1250 3.5 -0.5 -2.5 5.5 1.5 -0.5 1500 2.5 -1.0 -2.5 4.5 1.0 -0.5 1600 1.5 -2.0 -3.0 3.5 0.0 -1.0 2000 -1.5 -4.5 -3.5 0.5 -2.5 -1.5 2500 -4.0 -7.5 -6.0 -2.0 -5.5 -4.0 3000 -6.0 -11.0 -8.5 -4.0 -9.0 -6.5 3150 -6.0 -11.0 -8.0 -4.0 -9.0 -6.0 4000 -5.5 -9.5 -5.0 -3.5 -7.5 -3.0 5000 -1.5 -7.5 -5.5 0.5 -5.5 -3.5 6000 4.5 -3.0 -5.0 6.5 -1.0 -3.0 6300 6.0 -1.5 -4.0 8.0 0.5 -2.0 8000 12.5 7.0 4.0 14.5 9.0 6.0 WhiteNoise 0.0 0.0 0.0 0.0 0.0 0.0 ¹The Binaural to Monaural correction on +2dB come from ANSI S3.6 -2004 The difference between 0° - 45° - 90° come from ISO 8253-2 1998.

Free Field max SPL Free Field max HL is found by subtracting the selected RETSPL value Free Field Power Free Field Power Free Field Power Tone NB Tone NB Tone NB Max SPL Max SPL Max SPL Max SPL Max SPL Max SPL 95 85 100 95 80 70 95 85 100 95 80 70 95 85 105 100 85 75 95 85 105 100 85 75 95 85 105 100 85 75 95 85 105 100 90 80 95 85 105 100 90 80 95 85 105 100 90 80 95 85 105 100 90 80 95 85 105 100 90 80 95 85 105 100 90 80 95 85 105 100 90 80 95 85 105 100 90 80 95 85 105 100 90 80 95 85 105 100 90 80 95 85 100 95 90 80 95 85 105 95 90 80 95 85 105 95 90 80 95 85 105 100 90 80 95 85 110 100 90 80 95 85 105 100 90 80 95 85 105 95 90 80 90 75 95 90 90 80 90 100 85

Survey of reference and max hearing level Speech Audiometer. ANSI Speech. ANSI TDH39 Coupler: ANSI S3.7-1995 (NBS-9A) / IEC 60318-3 1998 (6ccm) Speech Audiometer Speech Speech Noise ANSI S3.6-2010 ANSI S3.6-2010 RETSPL MaxHL RETSPL MaxHL Linear Type A 19.5 110 19.5 100 Equ. FF Type A-E 15.5 105 15.5 100 Not Linear¹ 7.0 120 7.0 115 ILTASS 19.5 105

¹ This value come from pure tone 1kHz RETSPL value. (Not linear describe there is no equalizing of the signal flat electrical response)

ANSI Ear 3A Coupler: ANSI S3.7-1995 (HA-2 with 5mm rigid Tube) Speech Audiometer Speech Speech Noise ANSI S3.6-2010 ANSI S3.6-2010 RETSPL MaxHL RETSPL MaxHL Speech 12.5 110 12.5 100 ILTASS 12.5 100

ANSI HDA 280 Coupler: ANSI S3.7-1995 (NBS-9A) / IEC 60318-3 1998 (6ccm) Speech Audiometer Speech Speech Noise

Linear Type A Equ. FF Type A-E Not Linear¹ ILTASS

RETSPL 20.0 21.5 7.5

MaxHL 100 95 120

RETSPL 20.0 21.5 7.5 20.0

MaxHL 95 90 120 100

ANSI HDA 200 Coupler: IEC60318-2 with type 1 adaptor Speech Audiometer Speech Speech Noise ANSI S3.6-2010 ANSI S3.6-2010 Frequency RETSPL MaxHL RETSPL MaxHL Linear Type A 19.0 90 19.0 85 Equ. FF Type A-E 18.5 85 18.5 80 Not Linear¹ 5.5 110 5.5 105 ILTASS 19.0 90 ANSI DD45 Coupler: ANSI S3.7-1995 (NBS-9A) / IEC 60318-3 1998 (6ccm) Speech Audiometer Speech Speech Noise ANSI S3.6-2010 ANSI S3.6-2010 RETSPL MaxHL RETSPL MaxHL Linear Type A 18.5 110 18.5 100 Equ. FF Type A-E 18.5 100 18.5 100 Not Linear¹ 6.0 120 6.0 115 ILTASS 18.5 105

ANSI

Speech Speech Noise ILTASS

Speech ILTASS

ANSI Ear 5A Coupler: IEC 60318-5 2006 Speech Audiometer Speech Speech Noise ANSI S3.6-2010 ANSI S3.6-2010 RETSPL MaxHL RETSPL MaxHL 12.5 110 12.5 100 12.5 100

ANSI CIR 22/CIR 33 Coupler: ANSI S3.7-1995 (HA-2) Speech Audiometer Speech Speech Noise ANSI S3.6-2010 ANSI S3.6-2010 RETSPL MaxHL RETSPL MaxHL Speech 12.5 110 12.5 100 ILTASS 12.5 100

ANSI B71 Coupler: ANSI S3.13-1987 (R2002) Speech Audiometer Speech Speech Noise ANSI S3.6-2010 ANSI S3.6-2010 RETSPL MaxHL RETSPL MaxHL Speech 55.0 50 55.0 50 ILTASS 55.0 50

Free Field

ANSI S3.6-2010 Binaural Monaural 0° 45° 90° 0° 45° 90° RETSPL RETSPL RETSPL RETSPL RETSPL RETSPL 15.0 11.0 9.5 17.0 13.0 11.5 15.0 11.0 9.5 17.0 13.0 11.5 15.0 11.0 9.5 17.0 13.0 11.5

Free Field max SPL Free Field max HL is found by subtracting the selected RETSPL value Free Field Power Free Field Line Free Field Speaker 0° - 45° - 90° 0° - 45° - 90° 0° - 45° - 90° Max SPL Max SPL Max SPL 90 100 80 85 100 75 90 100 75

IEC Speech Calibration IEC TDH39 Coupler IEC 60318-3 1998 (6ccm) Speech Audiometer Speech Speech Noise IEC60645-2 1997 IEC60645-2 1997 RETSPL MaxHL RETSPL MaxHL Linear Type A 20.0 110 20.0 100 Equ. FF Type A-E 0.5 120 0.5 115 Not Linear¹ 7.0 120 7.0 115 ILTASS 20.0 105

IEC HDA 280 Coupler IEC 60318-3 1998 (6ccm) Speech Audiometer Speech Speech Noise IEC60645-2 1997 IEC60645-2 1997 RETSPL MaxHL RETSPL MaxHL Linear Type A 20.0 100 20.0 95 Equ. FF Type A-E 6.5 110 6.5 105 Not Linear¹ 7.5 120 7.5 120 ILTASS 20.0 100

IEC HDA 200 Coupler IEC60318-1 with type 1 adaptor Speech Audiometer Speech Speech Noise IEC60645-2 1997 IEC60645-2 1997 Frequency RETSPL MaxHL RETSPL MaxHL Linear Type A 20.0 90 20.0 85 Equ. FF Type A-E 3.5 100 3.5 95 Not Linear¹ 5.5 110 5.5 105 ILTASS 20.0 90 IEC DD45 Coupler IEC 60318-3 1998 (6ccm) Speech Audiometer Speech Speech Noise IEC60645-2 1997 IEC60645-2 1997 RETSPL MaxHL RETSPL MaxHL Linear Type A 20.0 110 20.0 100 Equ. FF Type A-E 3.5 115 3.5 115 Not Linear¹ 6.0 120 6.0 115 ILTASS 20.0 105

¹ This value come from pure tone 1kHz RETSPL value. (Not linear describe there is no equalizing of the signal flat electrical response)

Speech ILTASS

IEC Ear 3A Coupler IEC 60318-5 2006 Speech Audiometer Speech Speech Noise IEC60645-2 1997 IEC60645-2 1997 RETSPL MaxHL RETSPL MaxHL 20.0 100 20.0 90 20.0 90

Speech ILTASS

IEC Ear 5A Coupler IEC 60318-5 2006 Speech Audiometer Speech Speech Noise IEC60645-2 1997 IEC60645-2 1997 RETSPL MaxHL RETSPL MaxHL 20.0 100 20.0 90 20.0 90

Speech ILTASS

IEC CIR 22/CIR 33 Coupler IEC 60318-5 2006 Speech Audiometer Speech Speech Noise IEC60645-2 1997 IEC60645-2 1997 RETSPL MaxHL RETSPL MaxHL 20.0 90 20.0 90 20.0 90

Speech ILTASS

IEC B71 Coupler 60318-6 2007 Speech Audiometer Speech Speech Noise IEC60645-2 1997 IEC60645-2 1997 RETSPL MaxHL RETSPL MaxHL 55.0 50 55.0 50 55.0 50

IEC Free Field

Speech Speech Noise ILTASS

0° RETSPL 0.0 0.0 0.0

ISO 389-7 2005 Binaural Monaural 45° 90° 0° 45° 90° RETSPL RETSPL RETSPL RETSPL RETSPL 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0

Free Field max SPL Free Field max HL is found by subtracting the selected RETSPL value Free Field Power Free Field Line Free Field Speaker 0° - 45° - 90° 0° - 45° - 90° 0° - 45° - 90° Max SPL Max SPL Max SPL 90 100 80 85 100 75 90 100 75

Sweden speech calibration SWEDEN TDH39 Coupler IEC 60318-3 1998 (6ccm) Speech Audiometer Speech Speech Noise STAF 1996 STAF 1996 RETSPL MaxHL RETSPL MaxHL Linear Type A 22.0 105 27.0 90 Equ. FF Type A-E 0.5 120 0.5 115 Not Linear 22.0 105 27.0 90 ILTASS 27.0 90 SWEDEN HDA 280 Coupler IEC 60318-3 1998 (6ccm) Speech Audiometer Speech Speech Noise IEC60645-2 1997 IEC60645-2 1997 RETSPL MaxHL RETSPL MaxHL Linear Type A 20.0 100 20.0 95 Equ. FF Type A-E 6.5 110 6.5 105 Not Linear 7.5 120 7.5 120 ILTASS 20.0 100 SWEDEN HDA 200 Coupler IEC60318-1 with type 1 adaptor Speech Audiometer Speech Speech Noise IEC60645-2 1997 IEC60645-2 1997 Frequency RETSPL MaxHL RETSPL MaxHL Linear Type A 20.0 90 20.0 85 Equ. FF Type A-E 3.5 100 3.5 95 Not Linear 5.5 110 5.5 105 ILTASS 20.0 90 SWEDEN DD45 Coupler IEC 60318-3 1998 (6ccm) Speech Audiometer Speech Speech Noise STAF 1996 STAF 1996 RETSPL MaxHL RETSPL MaxHL Linear Type A 22.0 105 27.0 90 Equ. FF Type A-E 3.5 115 3.5 115 Not Linear 22.0 105 27.0 90 ILTASS 27.0 90

Speech ILTASS

SWEDEN EAR 3A Coupler IEC 60318-5 2006 Speech Audiometer Speech Speech Noise STAF 1996 STAF 1996 RETSPL MaxHL RETSPL MaxHL 21.0 100 26.0 85 26.0 85

Speech ILTASS

SWEDEN EAR 5A Coupler IEC 60318-5 2006 Speech Audiometer Speech Speech Noise STAF 1996 STAF 1996 RETSPL MaxHL RETSPL MaxHL 21.0 100 26.0 85 26.0 85

Speech ILTASS

SWEDEN CIR 22/CIR 33 Coupler IEC 60318-5 2006 Speech Audiometer Speech Speech Noise STAF 1996 STAF 1996 RETSPL MaxHL RETSPL MaxHL 21.0 90 26.0 85 26.0 85

Speech ILTASS

SWEDEN B71 Coupler 60318-6 2007 Speech Audiometer Speech Speech Noise IEC60645-2 1997 IEC60645-2 1997 RETSPL MaxHL RETSPL MaxHL 55.0 50 55.0 50 55.0 50

Sweden Free Field

Speech Speech Noise ILTASS

0° RETSPL 0.0 0.0 0.0

ISO 389-7 2005 Binaural Monaural 45° 90° 0° 45° 90° RETSPL RETSPL RETSPL RETSPL RETSPL 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0

Free Field max SPL Free Field max HL is found by subtracting the selected RETSPL value Free Field Power Free Field Line Free Field Speaker 0° - 45° - 90° 0° - 45° - 90° 0° - 45° - 90° Max SPL Max SPL Max SPL 90 100 80 85 100 75 90 100 75

Norway speech Calibration Norway TDH39 Coupler IEC 60318-3 1998 (6ccm) Speech Audiometer Speech Speech Noise Norway Norway RETSPL MaxHL RETSPL MaxHL Linear Type A 40.0 90 40.0 80 Equ. FF Type A-E 0.5 120 0.5 115 Not Linear 7.0 120 7.0 115 ILTASS 40.0 85 Norway HDA 280 Coupler IEC 60318-3 1998 (6ccm) Speech Audiometer Speech Speech Noise Norway Norway RETSPL MaxHL RETSPL MaxHL Linear Type A 40.0 80 40.0 75 Equ. FF Type A-E 6.5 110 6.5 105 Not Linear 7.5 120 7.5 120 ILTASS 40.0 80 Norway HDA 200 Coupler IEC60318-1 with type 1 adaptor Speech Audiometer Speech Speech Noise Norway Norway Frequency RETSPL MaxHL RETSPL MaxHL Linear Type A 40.0 70 40.0 65 Equ. FF Type A-E 3.5 100 3.5 95 Not Linear 5.5 110 5.5 105 ILTASS 40.0 70 Norway DD45 Coupler IEC 60318-3 1998 (6ccm) Speech Audiometer Speech Speech Noise Norway Norway RETSPL MaxHL RETSPL MaxHL Linear Type A 40.0 90 40.0 80 Equ. FF Type A-E 3.5 115 3.5 115 Not Linear 6.0 120 6.0 115 ILTASS 40.0 85

Speech ILTASS

Norway EAR 3A Coupler IEC 60318-5 2006 Speech Audiometer Speech Speech Noise Norway Norway RETSPL MaxHL RETSPL MaxHL 40.0 80 40.0 70 40.0 70

Speech ILTASS

Norway EAR 5A Coupler IEC 60318-5 2006 Speech Audiometer Speech Speech Noise Norway Norway RETSPL MaxHL RETSPL MaxHL 40.0 80 40.0 70 40.0 70

Speech ILTASS

Norway CIR 22/CIR 33 Coupler IEC 60318-5 2006 Speech Audiometer Speech Speech Noise Norway Norway RETSPL MaxHL RETSPL MaxHL 40.0 70 40.0 70 40.0 70

Speech ILTASS

Norway B71 Coupler 60318-6 2007 Speech Audiometer Speech Speech Noise Norway Norway RETSPL MaxHL RETSPL MaxHL 75.0 30 75.0 30 75.0 30

Norway Free Field

Speech Speech Noise ILTASS

0° RETSPL 0.0 0.0 0.0

ISO 389-7 2005 Binaural Monaural 45° 90° 0° 45° 90° RETSPL RETSPL RETSPL RETSPL RETSPL 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0

Free Field max SPL Free Field max HL is found by subtracting the selected RETSPL value Free Field Power Free Field Line Free Field Speaker 0° - 45° - 90° 0° - 45° - 90° 0° - 45° - 90° Max SPL Max SPL Max SPL 90 100 80 85 100 75 90 100 75

Equivalent free field Equivalent Free Field

Frequency 125 160 200 250 315 400 500 630 750 800 1000 1250 1500 1600 2000 2500 3000 3150 4000 5000 6000 6300 8000

Speech Audiometer HDA200 HDA280

TDH39 IEC60645-2 1997 ANSI S3.6-2010 IEC60318-3 1998 GF-GC -17,5 -14,5 -12,0 -9,5 -6,5 -3,5 -5,0 0,0

ISO389-8 2004 IEC60318-1 GF-GC -5,0 -4,5 -4,5 -4,5 -5,0 -5,5 -2,5 -2,5

-0,5 -0,5 -1,0

-3,0 -3,5 -2,0

-4,0 -6,0 -7,0

-5,5 -5,0 -6,0

-10,5 -10,5 -11,0

-7,0 -13,0 -14,5

-10,5 +1,5

-11,0 -8,5

PTB IEC60318-3 1998 GF-GC -15,0 -14,0 -12,5 -11,5 -10,0 -9,0 -8,0 -8,5 -5,0 -4,5 -6,5 -11,5 -12,5 -12,5 -9,5 -7 -10,5 -10,0 -14,5 -12,5 -14,5 -15,5 -9,0

DD45 PTB – DTU 2010 GF-GC -21.5 -17.5 -14.5 -12.0 -9.5 -7.0 -7.0 -6.5 -4.0 -3.5 -3.5 -7.0 -7.0 -9.5 -12.0 -8.0 -8.5 -9.0 -1.5

General properties for earphones Frequency

[Hz] 125 160 200 250 315 400 500 630 750 800 1000 1250 1500 1600 2000 2500 3000 3150 4000 5000 6000 6300 8000

Sound attenuation values for earphones Attenuation TDH39/DD45 with MX41/ EAR-Tone 3A HDA200 AR or PN 51 cushion EAR-Tone 5A [dB] [dB] [dB] 3 4 5 5 5 6 7 9 11 15 18 21 26 28 31 32 29 26 24

33,5

14,5

34,5

16

34,5

22,5

35,0

28,5

33,0

32

39,5

45,5

43,5

44

5.2 Affinity / Equinox Pin assignments Socket

Connector

Mains

Pin 1

Pin 2

Pin 3

Live

Neutral

Earth

Black Loudspeaker Signal Negative

Red Loudspeaker Signal Positive

-

Ground

Signal

IEC C13

FF1 / FF2 Terminal Block Left, Right Ins. Left, Ins. Right Bone Ins. Mask.

-

TB Ref.

Ground

Monitor, Ass. Mon. TB Lsp.

6.3mm Mono

HF/HLS

Signal & DC bias

Signal Negative

Signal Positive

Loudspeaker Signal Negative

Loudspeaker Signal Positive

Ground

Right

Left

Ground

DC bias

Signal

Vbat-

Sense

Vbat+

-

Return

Signal

Ground

DC bias

Signal

Vbat-

Sense

Vbat+

-

Ground

Signal & DC bias

Ground

Signal

Ground

DC

Talk Back Mic. 1/TF & Mic. 2 Inp. Aux. 1 & 2 TB Coupler Batt. Sim. TB Loop, FF Loop Pat. Resp. L & R

6.3mm Stereo

TB Coupler - internal TB (Affinity2.0 only) Batt. Sim. - Internal TB (Affinity2.0 only)

3.5mm Stereo

TB Ref – internal TB (Affinity2.0 only)

-

Binder Series 719 3 pole FF1 & FF2 Sp 1, Sp 2, Sp 3, Sp 4 CD1 & CD2

-

RCA

DC DC Supply

-

Sp. 1-4 Power Out

Sub-D 9 pole

Insitu L & R

1.

Speaker 1 -

1.

Ground

2.

Speaker 2 -

2.

Speaker signal

3.

Speaker 3 -

3.

Ground

4.

Speaker 4 -

4.

-

5.

-

5.

DC bias – Probe mic.

6.

Speaker 1 +

6.

Signal & DC bias – Ref. mic.

7.

Speaker 2 +

7.

Ground

8.

Speaker 3 +

8.

Signal - Probe mic.

9.

Speaker 4 +

DIN 7 pole

USB

Housing. Ground

USB/PC

1.

+5 VDC

1.

+5 VDC

2.

Data -

2.

Data -

3.

Data +

3.

Data +

4.

Ground

4.

Ground

Keyb.

DIN 9 pole

1.

Keyboard Power +5 VDC (limited)

2.

Keyboard attached / Chip select.

3.

Master Transmit Slave Receive

4.

Key Interrupt

5.

Master Receive Slave Transmit

6.

Serial Clock

7.

TF–signal (Talk Forward mic.)

8.

Ground

9.

Ground

Housing. Ground

5.3 Electromagnetic Compatibility (EMC)

Portable and mobile RF communications equipment can affect the Affinity. Install and operate the Affinity according to the EMC information presented in this chapter. The Affinity has been tested for EMC emissions and immunity as a standalone instrument. Do not use the Affinity adjacent to or stacked with other electronic equipment. If adjacent or stacked use is necessary, the user should verify normal operation in the configuration. The use of accessories, transducers and cables other than those specified, with the exception of servicing parts sold by Interacoustics as replacement parts for internal components, may result in increased EMISSIONS or decreased IMMUNITY of the device. Anyone connecting additional equipment is responsible for making sure the system complies with the IEC 60601-1-2 standard. Guidance and manufacturer’s declaration - electromagnetic emissions The Affinity is intended for use in the electromagnetic environment specified below. The customer or the user of the Affinity should assure that it is used in such an environment. Emissions Test Compliance Electromagnetic environment - guidance RF emissions Group 1 The Affinity uses RF energy only for its internal function. CISPR 11 Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment. RF emissions Class B Limits The Affinity is suitable for use in all commercial, industrial, business, CISPR 11 and residential environments. Harmonic emissions Complies IEC 61000-3-2 Class A Category Voltage fluctuations / Complies flicker emissions IEC 61000-3-3 Recommended separation distances between portable and mobile RF communications equipment and the Affinity. The Affinity is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Affinity can help prevent electromagnetic interferences by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Affinity as recommended below, according to the maximum output power of the communications equipment. Rated Maximum output Separation distance according to frequency of transmitter power of transmitter [m] [W] 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz d = 1.17 d = 1.17 d = 2.23 0.01

0.12

0.12

0.23

0.1

0.37

0.37

0.74

1

1.17

1.17

2.33

10 3.70 3.70 7.37 100 11.70 11.70 23.30 For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. Note 1 At 80 MHz and 800 MHZ, the higher frequency range applies. Note 2 These guidelines may not apply to all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. Guidance and Manufacturer’s Declaration - Electromagnetic Immunity The Affinity is intended for use in the electromagnetic environment specified below. The customer or the user of the Affinity should assure that it is used in such an environment. Immunity Test IEC 60601 Test Compliance Electromagnetic level Environment-Guidance Electrostatic Discharge (ESD)

+6 kV contact

+6 kV contact

Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be greater than 30%. Mains power quality should be that of a typical commercial or residential environment.

IEC 61000-4-2

+8 kV air

+8 kV air

Electrical fast transient/burst

+2 kV for power supply lines

+2 kV for power supply lines

IEC61000-4-4

+1 kV for input/output lines

+1 kV for input/output lines

Surge

+1 kV differential mode

+1 kV differential mode

IEC 61000-4-5

+2 kV common mode

+2 kV common mode

Mains power quality should be that of a typical commercial or residential environment.

Voltage dips, short

< 5% UT (>95% dip in UT)

< 5% UT (>95% dip in UT)

(>95% dip in UT)

interruptions and voltage variations on power supply lines

for 0.5 cycle

for 0.5 cycle

40% UT (60% dip in UT) for 5 cycles

40% UT (60% dip in UT) for 5 cycles

70% UT (30% dip in UT) for 25 cycles

70% UT (30% dip in UT) for 25 cycles

<5% UT (>95% dip in UT) for 5 sec

<5% UT

3 A/m

3 A/m

IEC 61000-4-11

Power frequency (50/60 Hz) IEC 61000-4-8

Note: UT is the A.C. mains voltage prior to application of the test level.

for 5 sec Mains power quality should be that of a typical commercial or residential environment. If the user of the Affinity requires continued operation during power mains interruptions, it is recommended that the Affinity be powered from an uninterruptable power supply or its battery. Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or residential environment.

Return Report – Form 001 Opr. dato:

2008-10-03

af:

EC

Rev. dato:

af:

HNI

Rev. nr.:

4 Address Drejervaenget 8 5610 Assens Denmark

Company: Address:

Phone (+45) 63713555 Fax (+45) 63713522

Phone:

E-mail [email protected]

Fax or e-mail: Contact person:

Date :

Following item is reported to be: returned to INTERACOUSTICS for:

repair,

exchange,

other:

defective as described below with request of assistance repaired locally as described below showing general problems as described below Item:

Type:

Quantity:

Serial No.:

Supplied by:

Included parts: Important! - Accessories used together with the item must be included if returned (e.g. external power supply, headsets, transducers and couplers). Description of problem or the performed local repair:

Returned according to agreement with: Date :

Interacoustics,

Other : Person :

Please provide e-mail address or fax No. to whom Interacoustics may confirm reception of the returned goods: The above mentioned item is reported to be dangerous to patient or user

1

In order to ensure instant and effective treatment of returned goods, it is important that this form is filled in and placed together with the item. Please note that the goods must be carefully packed, preferably in original packing, in order to avoid damage during transport. (Packing material may be ordered from Interacoustics)

1

EC Medical Device Directive rules require immediate report to be sent, if the device by malfunction deterioration of performance or characteristics and/or by inadequacy in labelling or instructions for use, has caused or could have caused death or serious deterioration of health to patient or user. Page 1 of 1