Interacoustics AD629 Instructions For Use Manual Download Page 47

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D-0133833-A – 2022/09
AD629 - Instructions for Use - EN

Page 44

General technical specifications

5.1 AD629 technical specification

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)

Calibration

Calibration information and instructions is located in the AD629 Service

manual

Air

Conduction

DD45:

PTB/DTU report 2009

TDH39:

ISO 389-1 1998, ANSI S3.6-2010

HDA300:

PTB report PTB 1.61 – 4064893/13

HDA280

PTB report 2004

DD65 v2 PTB 1.61-4091606 2018

& AAU 2018

E.A.R Tone 3A/5A:

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

IP 30:

ISO 389-2 1994, ANSI S3.6-2010 DES-2361

Bone

Conduction

B71:

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

Placement: Mastoid

Free Field

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

High

Frequency

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

Effective

masking

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

Transducers

DD45

Headband Static Force 4.5N

0.5N

TDH39

Headband Static Force 4.5N

0.5N

HDA300

Headband Static Force 4.5N

0.5N

HDA280

Headband Static Force 5N

0.5N

DD450 Headband Static Force 10N

0.5N

DD65 v2 Headband Static Force 10N

0.5N

B71 Bone

Headband Static Force 5.4N

0.5N

E.A.R Tone 3A/5A:

IP30

Patient Response switch

One hand held push button.

Patient communication

Talk Forward (TF) and Talk Back (TB).

Monitor

Output through built-in speaker or through external earphone or speaker.

Summary of Contents for AD629

Page 1: ...Instructions for Use EN AD629 Science made smarter D 0133833 A 2022 09 ...

Page 2: ...reens and function key descriptions 14 Tone test 15 Stenger test 15 ABLB Fowler test 16 Tone in noise test Langenbeck test 16 Weber 17 Speech test 17 Speech CH2On 20 Speech in noise 20 3 6 Setup 26 AD629 setup 27 Common settings 27 Tone settings 29 Speech settings 30 Auto settings 31 Sessions and clients 31 Save session 32 Clients 32 3 7 Printing 33 3 8 AD629 stand alone unit print logo update 33 ...

Page 3: ...NERAL TECHNICAL SPECIFICATIONS 44 5 1 AD629 technical specification 44 5 2 Survey of reference and max hearing level tone audiometer 48 5 3 AD629 pin assignments 59 5 4 Electromagnetic compatibility EMC 60 ...

Page 4: ... of diagnostic audiometer depends on the interaction with the patient However for patients not responding well possibilities of various tests allow the tester to have at least some evaluative result Thus a normal hearing result should not allow for ignoring other contra indications in this case A full audiologic evaluation should be administered if concerns about hearing sensitivity persist The AD...

Page 5: ...vigilance requirements Interacoustics shall handle all the product complaints and adverse events as per the internal procedure 1 Applied parts according to IEC60601 1 Included parts DD45 Audiometric headset1 B71 Bone conductor1 APS3 Patient response button1 Goose neck microphone Power cable Operation manual CD Multilingual Instructions for Use Optional parts Diagnostic Suite software OtoAccess dat...

Page 6: ...ny need for return or service Reporting and returning procedure Any missing part or malfunction or any damaged components due to shipment should be reported immediately to the supplier local distributor along with the invoice serial number and a detailed report of the issue For any on site service related information please contact your local distributor If the system components are to be returned...

Page 7: ...l indicates that when the end user wishes to discard this product it must be sent to separate collection facilities for recovery and recycling 0123 The CE mark indicates that Interacoustics A S meets the requirements of Annex II of the Medical Device Directive 93 42 EEC TÜV Product Service Identification No 0123 has approved the quality system Year of manufacture Manufacturer Medical Device ETL li...

Page 8: ...ive If the AD629 is connected to a PC IT equipment forming a system ensure not to touch the patient while operating the PC A Separation Device isolation device is needed to isolate the equipment located outside the patient environment from the equipment located inside the patient environment In particular such a Separation Device is required when a network connection is made The requirement for th...

Page 9: ...ntatives may result in increased emission or decreased immunity of the equipment For a list of accessories transducers and cables that fulfil the requirements please also refer to the appendix regarding EMC NOTICE To prevent system faults take appropriate precautions to avoid PC viruses and similar Using operating systems where Microsoft have discontinued software and security support will increas...

Page 10: ...eck microphone can be plugged into the top part of the AD629 just above the Talk Forward button This can be used for talk forward When not plugged in the goose neck microphone can be placed underneath the display Please refer to the section about patient communication for more details The upper right side of the AD629 holds the on off switch of the AD629 Make sure that the audiometer is placed so ...

Page 11: ...LAN connection is currently not used for any application only internally in production Mic 2 Please refer to the section about Patient Communication Talk Forward and Talk Back CD input It is required that any attached CD player has a linear frequency response in order to comply with the requirements of IEC 60645 2 USB connections is used for PC connection to Diagnostic Suite the large USB connecto...

Page 12: ...level the clinician would adjust the HL dB dial 41 to the appropriate level To adjust the Intensity level the dial in channel 2 43 would be used Talk back The operator may use Talk Back 28 in one of the following ways If no headphone is connected to the Talk Back left side connector the voice is wired through the Talk Back speakers next to the display 2 If a headphone headset is connected to the A...

Page 13: ...st cabin 2 Talk back Speaker For speech feedback from the patient in the test cabin 3 Color Display Screen For displaying the different test screens Will be further explained in the sections describing the individual tests 4 Tone and Response Indicator Indication light seen when a tone is presented to the patient Indication light seen when the patient activates the patient signal using the patient...

Page 14: ...fault for the next session press Shift 15 and then 14 Choose between the different settings using the right rotary wheel 43 Change the individual settings using the left rotary wheel 41 18 Delete del curve Delete points during testing delete Delete the entire test curve of a graph by holding Shift 15 together with this button 19 Save Session New Session Saving a session after testing or alternativ...

Page 15: ...ent from e g CD can be heard through the built in monitor of the AD629 or monitor headset in both channel 1 and 2 Adjust the gain by holding down the button for one second 28 Talk Back Talk back when active allows the clinician to hear comments or responses from the patient through the AD629 or monitor headset Adjust the gain by holding down the button for one second 29 Right Insert For selecting ...

Page 16: ... has shown no response to stimuli 39 Down Incorrect Used to decrease the frequency level The AD629 has an incorporated automatic speech score counter Therefore as a second function you can use this button as an Incorrect button when performing speech tests For automatic speech score counting while testing speech push this button after each word not heard correctly by the patient 40 Up Correct Used...

Page 17: ...beck Weber Speech Auto Hughson Westlake Auto Békésy QuickSIN Quick speech in noise SISI Short increment sensitivity index MHA Master Hearing Aid HLS Hearing Loss Simulator The optional HF High Frequency HFz High Frequency Zoom test features are activated from the Tone Screen i e as extensions to the Tone audiogram test screen Please note that the tests available in this list depend on the test lic...

Page 18: ...g type by using one of the rotary wheels 41 43 12 Not used in this test screen 13 Switch between magnified top bar and normal sized top bar 14 View the masking levels dual audiogram mode only 15 Multi frequency optional MF license 16 High Frequency optional HF license 17 High Frequency Zoom optional HF license Stenger test The Stenger test is a test when a patient is suspected of feigning faking a...

Page 19: ...ears The intensity is fixed in the impaired ear 20 dB above pure tone threshold The task of the patient is to adjust the level of the better ear until the signal in the two ears is of equal intensity Note however that the test may also be performed by fixing the intensity in the normal hearing ear and having the patient set the tone for the impaired ear Please refer to the Tone Test section above ...

Page 20: ...their relatives report that they have trouble hearing speech Speech audiometry has the advantage of other speech signals and is used to quantify the patient s ability to understand everyday communication It examines the patient s processing ability in relation to their degree and type of hearing loss which can vary greatly between patients with the same hearing loss configuration Speech audiometry...

Page 21: ...e until you reach an average of approximately 0 dB VU on the VU meter NOTICE If the speech and calibration signal are not the same level it must be manually corrected The speech screen set up in table mode using wave files 23 under Setup 16 Function key Description 10 Only available if High Frequency is available optional license on the AD629 Selects the HF phone connected to the separate HF conne...

Page 22: ... recording mode if the protocol has been set to continue timeout after the word has been played the word will be grey colored waiting for the operator s input The input can either be Correct 40 Incorrect 39 on the keyboard or by using the Phoneme score on the F buttons The tested can be paused on the play pause button If the recording mode has been set to manual the words can be selected one by on...

Page 23: ...ise the speech material and speech in noise is presented in the same ear Hughson Westlake test Hughson Westlake is an automatic pure tone test procedure The threshold of hearing is defined as 2 out of 3 or 3 out of 5 correct responses at a certain level in a 5dB increase and a 10dB decrease test procedure Function key Description 10 Show traces 11 Select other 20y 12 Test high frequencies 15 Singl...

Page 24: ...al when responses to continuous and pulsed tones are compared The Békésy test is a fixed frequency test Pure tone or narrow band noise can be selected As a standard a continuous tone is selected for the Békésy test if pulsing tones are preferred this can be changed by pressing Settings 16 and changing continuous to pulse Please refer to the HW Test section above for key function descriptions for F...

Page 25: ...resented in four talker babble noise The sentences are presented at pre recorded signal to noise ratios which decrease in 5 dB steps from 25 very easy to 0 extremely difficult The SNRs used are 25 20 15 10 5 and 0 encompassing normal to severely impaired performance in noise For more information please refer to Etymotic Research s QuickSINTM Speech in Noise Test manual version 1 3 Function key Des...

Page 26: ...ncy It can be used to differentiate between cochlear and retro cochlear disorders as a patient with a cochlear disorder will be able to perceive the increments of 1 dB as where a patient with a retro cochlear disorder will not Function key Description 10 Only available if High Frequency is available optional license on the AD629 Selects the HF phone connected to the separate HF connectors 11 Ampli...

Page 27: ...el master hearing aid Function key Description 10 Only available if High Frequency is available optional license on the AD629 Selects the HF phone connected to the separate HF connectors 11 Filter channel 1 12 Filter channel 2 15 If MHA HIS wave file is installed they can be selected here 16 Start MHA test 17 Stop MHA test MHA HIS wave files can be installed the following way 1 Zip the selected wa...

Page 28: ... what the hearing loss actually sounds like gives an impression of what the hearing impaired goes through every day Function key Description 10 Only available if High Frequency is available optional license on the AD629 Selects the HF phone connected to the separate HF connectors 11 Right channel on 12 Left channel on 13 Select which audiogram data to use for the HLS test 15 If MHA HIS wave file i...

Page 29: ...o enter other settings menus hold the Setup button and use on of the rotary wheels 41 43 to select To save the settings use Save all settings as To use another user setting protocol profile use Load user settings name of user setting Inside a settings menu choose between the different settings using the right rotary wheel 43 Change the individual settings using the left rotary wheel 41 Here an exa...

Page 30: ...D 0133833 A 2022 09 AD629 Instructions for Use EN Page 27 AD629 setup The screen shot below shows the AD629 settings menu Common settings The screen shot below shows the common settings menu ...

Page 31: ...ey Description 10 Select client list 11 Install new firmware or wave files from USB stick Uninstall items Use shift to activate this 16 Go back 17 Save user setting protocol New audiometric symbol schemes are installed via the Diagnostic Suite under General Setup The same applies to the clinic logo shown on the direct printout ...

Page 32: ...09 AD629 Instructions for Use EN Page 29 Tone settings The screen shot below shows settings for pure tone testing Function key Description 10 Show settings for the speech banana 16 Go back 17 Save user setting protocol ...

Page 33: ... Instructions for Use EN Page 30 Speech settings The screen shot below shows settings for Speech testing Function key Description 10 Phoneme norm curve settings 11 FF norm curve setting 16 Go back 17 Save user setting protocol ...

Page 34: ... 16 Go back 17 Save user setting protocol Sessions and clients Save a session 19 after testing or alternatively create a new session by holding Shift 15 and pressing the Save Session button In the Save Session 19 menu it is possible to save sessions delete and create clients and edit client names ...

Page 35: ...tion 10 Delete the selected client 11 Edit the selected client 12 Create new client 16 Return to the session 17 Save session under the selected client Clients Function key Description 10 Delete the selected client 16 Return to the session 17 Access the sessions saves under the selected client ...

Page 36: ... combined printouts e g together with the AT235 or Titan Middle Ear Analysers 3 8 AD629 stand alone unit print logo update 1 Open up the Paint program 2 Open up Image Properties by pushing the Ctrl E keys 3 Set the Width to 945 and the Height to 190 as shown Click on OK 4 Edit the Image and the Company data to fit inside the set area 5 Save the created file as PrintLogo bmp 6 Zip the PrintLogo bmp...

Page 37: ...ormatted thumb drive 12 It is very important that this file and only this file is present on the USB thumb drive 13 With the audiometer turned off insert the thumb drive into any available USB port 14 Turn on the AD629 and push the Temp Setup button from the Tone test screen 15 Enter Common Settings using the Setup Tests button 16 For the question Do you want to install press the Yes button 17 Aft...

Page 38: ... chapter for audiometric data transfer Important Please be sure to select the AD629 version 2 and not AD629 which refers to the old version PC controlled AD629 Unselect this if you want to run the AD629 as a standalone audiometer i e not as a hybrid audiometer but still being connected to the Diagnostic Suite When pressing Save Session on the AD629 the session will automatically be transferred to ...

Page 39: ...sferred to the Diagnostic Suite as follows When pressing Save Session on the AD629 the session will automatically be transferred to the Diagnostic Suite Start the suite with device connected The SYNC tab If several sessions are stored on the AD629 under one or more patients the Sync tab must be used The screen shot below shows the Diagnostic Suite with the SYNC tab open underneath the AUD and IMP ...

Page 40: ...teria Use the Add button to transfer upload the client from the database to the internal AD629 memory The internal AD629 memory can hold up to 1000 clients and 50 000 sessions audiogram data On the right side the clients currently stored on the internal AD629 memory hardware is down It is possible to remove all clients for individual clients using the Remove all or Remove buttons Session download ...

Page 41: ...D 0133833 A 2022 09 AD629 Instructions for Use EN Page 38 When pressing the icon the functionality of the Session download screen is described ...

Page 42: ...audiometer Operate the unit via a PC and Operate the PC via the unit The AC440 operational manual explains in more detail how the AUD module works when running it in hybrid mode Please note that the AC440 manual is covering the full clinical AC440 module for the Equinox and Affinity PC based audiometers so some features will not be present in the AD629 Diagnostic Suite AUD module The protocol sett...

Page 43: ...se keys and check your Suite Firmware and Build Versions Also in this window you will find the Checksum section which is a feature designed to help you identify the integrity of the software It works by checking the file and folder content of your software version This is using an SHA 256 algorithm On opening the checksum you will see a string of characters and numbers you can copy this by double ...

Page 44: ...rry out any setting up adjustments as specified On battery powered equipment check battery state 4 Check that earphone and bone vibrator serial numbers are correct for use with the audiometer 5 Check that audiometer output is approximately correct on both air and bone conduction by conducting a simplified audiogram on a known test subject with known hearing check for any change 6 Check at high lev...

Page 45: ... ear tips are single use components Ensure isopropyl alcohol does not come into contact with any screens on the AD629 Recommended cleaning and disinfection solutions Warm water with mild nonabrasive cleaning solution soap 70 isopropyl alcohol Procedure Clean the AD629 by wiping outer case with a lint free cloth lightly dampened in cleaning solution Clean cushions and patient hand switch and other ...

Page 46: ...eracoustics product This shall apply solely to the original purchaser This warranty shall not apply to any subsequent owner or holder of the product Furthermore this warranty shall not apply to and Interacoustics shall not be responsible for any loss arising in connection with the purchase or use of any Interacoustics product that has been repaired by anyone other than an authorized Interacoustics...

Page 47: ...manual Air Conduction DD45 PTB DTU report 2009 TDH39 ISO 389 1 1998 ANSI S3 6 2010 HDA300 PTB report PTB 1 61 4064893 13 HDA280 PTB report 2004 DD65 v2 PTB 1 61 4091606 2018 AAU 2018 E A R Tone 3A 5A ISO 389 2 1994 ANSI S3 6 2010 IP 30 ISO 389 2 1994 ANSI S3 6 2010 DES 2361 Bone Conduction B71 ISO 389 3 1994 ANSI S3 6 2010 Placement Mastoid Free Field ISO 389 7 2005 ANSI S3 6 2010 High Frequency I...

Page 48: ...ion Wave file 44100Hz 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 2001 5 12 Octave filter with the same centre frequency resolution as pure Tone White noise 80 20000Hz measured with constant bandwidth Speech Noise IEC 60645 2 1993 125 6000Hz falling 12dB octa...

Page 49: ... linear 2 THD at 1000 Hz max output 9 dB increasing at lower frequency Level range 10 to 50 dB HL 1 Ext sign CD input 2 Int sign Wave files External signal Speech replaying equipment connected to the CD 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 dBVU Free Field Power amplifier and louds...

Page 50: ...0uVrms at max gain for 0dB reading Input impedance 3 2KOhm TF front panel 100uVrms at max gain for 0dB reading Input impedance 3 2KOhm Wave files Plays wave file from hard disk drive Output Specifications FF1 2 7Vrms at min 2KOhm load 60 20000Hz 3dB Left Right 7Vrms at 10 Ohms load 60 20000Hz 3dB Ins Left Right 7Vrms at 10 Ohms load 60 20000Hz 3dB Bone 7Vrms at 10 Ohms load 60 10000Hz 3dB Ins Mask...

Page 51: ...oupler 6ccm 6ccm 6ccm Artificial ear Artificial ear Artificial ear Artificial ear 2ccm 2ccm 2ccm Mastoid Mastoid RETSPL RETSPL RETSPL RETSPL RETSPL RETSPL RETSPL RETSPL RETSPL RETSPL RETFL RETFL Tone 125 Hz 47 5 45 38 5 30 5 27 30 5 30 5 26 26 26 Tone 160 Hz 40 5 37 5 33 5 26 24 5 25 5 26 22 22 22 Tone 200 Hz 33 5 31 5 29 5 22 22 5 21 2 22 18 18 18 Tone 250 Hz 27 25 5 25 18 20 17 18 14 14 14 67 67...

Page 52: ...5 Tone 750 Hz 120 120 120 120 120 115 120 115 115 120 70 75 Tone 800 Hz 120 120 120 120 120 115 120 115 115 120 70 75 Tone 1000 Hz 120 120 120 120 120 115 120 120 120 120 70 85 Tone 1250 Hz 120 120 120 110 120 115 110 120 120 120 70 90 Tone 1500 Hz 120 120 120 115 120 115 115 120 120 120 70 90 Tone 1600 Hz 120 120 120 115 120 115 115 120 120 120 70 90 Tone 2000 Hz 120 120 120 115 120 115 115 120 1...

Page 53: ...62 NB 630 Hz 14 13 5 15 5 13 11 13 9 9 9 57 5 57 5 NB 750 Hz 11 5 12 5 14 11 9 5 11 7 7 7 53 5 53 5 NB 800 Hz 11 5 12 13 5 11 9 11 6 5 6 5 6 5 52 52 NB 1000 Hz 12 13 13 5 11 5 8 11 5 6 6 6 48 5 48 5 NB 1250 Hz 13 12 5 14 5 12 8 5 12 8 8 8 45 45 NB 1500 Hz 14 12 5 15 5 11 5 9 11 5 8 8 8 42 5 42 5 NB 1600 Hz 14 13 15 11 5 8 5 11 5 8 8 8 41 5 41 5 NB 2000 Hz 14 15 14 10 5 6 10 5 9 9 9 37 37 NB 2500 H...

Page 54: ... 100 110 110 110 60 65 NB 800 Hz 110 110 105 100 105 105 100 110 110 110 60 65 NB 1000 Hz 110 110 105 100 105 105 100 110 110 110 60 70 NB 1250 Hz 110 110 105 95 105 105 95 110 110 110 60 75 NB 1500 Hz 110 110 105 100 105 105 100 110 110 110 60 75 NB 1600 Hz 110 110 105 100 105 105 100 110 110 110 60 75 NB 2000 Hz 110 110 105 100 105 105 100 110 110 110 65 70 NB 2500 Hz 110 110 105 100 110 105 100...

Page 55: ...Max HL Max HL Max HL Max HL Max HL Max HL Max HL Max HL Max HL Max HL Speech 110 110 100 90 100 100 90 Speech Equ FF 100 105 95 85 95 95 85 Speech Non linear 120 120 120 110 120 110 110 110 110 110 60 60 Speech noise 100 100 95 85 95 95 85 Speech noise Equ FF 100 100 90 80 95 90 80 Speech noise Non linear 115 115 120 105 120 105 105 110 110 100 50 50 White noise in speech 95 95 95 90 100 95 90 95 ...

Page 56: ... HL Max HL Max HL Max HL Max HL Max HL Speech 110 110 100 90 95 95 90 Speech Equ FF 115 120 110 100 110 110 100 Speech Non linear 120 120 120 110 120 110 110 100 100 100 60 60 Speech noise 100 100 95 85 90 90 85 Speech noise Equ FF 115 115 105 95 110 100 95 Speech noise Non linear 115 115 120 105 120 105 105 90 90 90 50 50 White noise in speech 95 95 95 90 95 95 90 85 85 85 55 60 IEC speech RETSPL...

Page 57: ...report 2013 DD450 GF GC ANSI S3 6 2018 and ISO 389 8 2004 Sweden Speech level STAF 1996 and IEC60645 2 1997 acoustical linear weighting Sweden Speech Equivalent free field level GF GC from IEC60645 2 1997 acoustical equivalent sensitivity weighting Sweden Speech Not linear level 1 kHz RETSPL DD45 TDH39 HDA200 HDA300 and EAR 3A IP30 CIR22 33 B71 B81 STAF 1996 and IEC60645 2 1997 no weighting Sweden...

Page 58: ... 8 2004 HDA300 GF GC PTB report 2013 DD450 GF GC ANSI S3 6 2018 and ISO 389 8 2004 Norway Speech level IEC60645 2 1997 20dB acoustical linear weighting Norway Speech Equivalent free field level GF GC from IEC60645 2 1997 acoustical equivalent sensitivity weighting Norway Speech Not linear level 1 kHz RETSPL DD45 TDH39 HDA200 HDA300 and EAR 3A IP30 CIR22 33 B71 B81 IEC60645 2 1997 20dB no weighting...

Page 59: ...03 5 98 5 2500 4 7 5 6 2 101 96 3000 6 11 8 5 2 104 94 3150 6 11 8 2 104 94 4000 5 5 9 5 5 2 104 5 99 5 5000 1 5 7 5 5 5 2 108 5 98 5 6000 4 5 3 5 2 104 5 99 5 6300 6 1 5 4 2 106 96 8000 12 5 7 4 2 92 5 87 5 WhiteNoise 0 4 5 5 2 100 ANSI free field ANSI S3 6 2010 Free Field max SPL Free Field max HL is found by subtracting the selected RETSPL value Binaural Binaural to Monaural Free Field Line 0 4...

Page 60: ...peech Noise 0 4 5 5 5 2 2 100 Speech WN 2 5 1 5 3 2 5 0 5 2 97 5 Equivalent free field Speech Audiometer TDH39 DD45 HDA280 HDA200 HDA300 IEC60645 2 1997 PTB DTU 2010 PTB ISO389 8 2004 PTB 2013 ANSI S3 6 2010 Coupler IEC60318 3 IEC60318 3 IEC60318 3 IEC60318 1 IEC60318 1 Frequency GF GC GF GC GF GC GF GC GF GC 125 17 5 21 5 15 0 5 0 12 0 160 14 5 17 5 14 0 4 5 11 5 200 12 0 14 5 12 5 4 5 11 5 250 9...

Page 61: ...R 3A IP30 EAR 5A HDA200 HDA300 Hz dB dB dB dB 125 3 33 15 12 5 160 4 34 15 200 5 35 16 250 5 36 16 12 7 315 5 37 18 400 6 37 20 500 7 38 23 9 4 630 9 37 25 750 800 11 37 27 1000 15 37 29 12 8 1250 18 35 30 1500 1600 21 34 31 2000 26 33 32 15 1 2500 28 35 37 3000 3150 31 37 41 4000 32 40 46 28 8 5000 29 41 45 6000 6300 26 42 45 8000 24 43 44 26 2 ISO 8253 1 2010 ...

Page 62: ...nt panel Pat Resp CD 3 5mm Stereo Ground CD2 CD1 TF side panel Ground DC bias Signal Monitor side panel Ground Right Left FF1 FF2 RCA Ground Signal 5 3 AD629 pin assignments USB A 4 x Host USB B Device 1 5 VDC 1 5 VDC 2 Data 2 Data 3 Data 3 Data 4 Ground 4 Ground LAN Ethernet RJ45 Socket RJ45 Cable Plug 1 TX Transmit Data 1 TX Transmit Data 2 RX Receive Data 3 Not connected 4 Not connected 5 RX Re...

Page 63: ...and cables can be found in this section Portable RF communications equipment including peripherals such as antenna cables and external antennas should be used no closer than 30 cm 12 inches to any part of this equipment including cables specified by the manufacturer Otherwise degradation of the performance of this equipment could result in improper operation This equipment complies with IEC60601 1...

Page 64: ...onment in which radiated RF disturbances are controlled The customer or the user of the AD629 can help prevent electromagnetic interferences by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the AD629 as recommended below according to the maximum output power of the communications equipment Rated Maximum output power of transmitter W Separat...

Page 65: ...t Surge IEC 61000 4 5 1 kV differential mode 2 kV common mode 1 kV differential mode 2 kV common mode Mains power quality should be that of a typical commercial or residential environment Voltage dips short interruptions and voltage variations on power supply lines IEC 61000 4 11 5 UT 95 dip in UT for 0 5 cycle 40 UT 60 dip in UT for 5 cycles 70 UT 30 dip in UT for 25 cycles 5 UT 95 dip in UT for ...

Page 66: ... Field strengths from fixed RF transmitters as determined by an electromagnetic site survey a should be less than the compliance level in each frequency range b Interference may occur in the vicinity of equipment marked with the following symbol NOTE1 At 80 MHz and 800 MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affe...

Page 67: ... Returned according to agreement with Interacoustics Other Date 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 P...

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