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11

Standards and Safety

This manual contains information, which must be followed to ensure the safe performance of the devices and software
covered by this manual. Local government rules and regulations, if applicable, should also be followed at all times.

See

and

Warnings, cautions, and notes

11.1

Madsen A450

Symbol

Standards

Reference

Standard Title of Symbol

Symbol Title as

per Referenced

Standard

Explanation

EU Medical
Device Regu-
lations
2017/745

REGULATION (EU) 2017/745
OF THE EUROPEAN
PARLIAMENT AND OF THE
COUNCIL of 5 April 2017 on
medical devices, amending Dir-
ective 2001/83/ EC, Regu-
lation (EC) No 178/2002 and
Regulation (EC) No 1223/2009
and repealing Council Dir-
ectives 90/385/ EEC and
93/42/EEC

CE marking

(43) ‘CE marking of con-
formity’ or ‘CE marking’
means a marking by which
a manufacturer indicates
that a device is in con-
formity with the applic-
able requirements set out
in this Regulation and
other applicable Union
harmonisation legislation
providing for its affixing

ISO 15223-
1:2016 Refer-
ence no.
5.1.1 (ISO
7000-3082)

Medical devices — Symbols to
be used with medical device
labels, labelling and inform-
ation to be supplied.

Manufacturer

Indicates the medical
device manufacturer.

ISO 15223-
1:2016 Refer-
ence no.
5.1.3. (ISO
7000-2497)

Medical devices — Symbols to
be used with medical device
labels, labelling and inform-
ation to be supplied – Part 1:
General requirements.

Date of man-
ufacture

Indicates the date when
the medical device was
manufactured.

ISO 15223-
1:2016 Refer-
ence no.
5.1.4. (ISO
7000-2607)

Medical devices — Symbols to
be used with medical device
labels, labeling, and inform-
ation to be supplied – Part 1:
General requirements.

Use-by date

Indicates the date after
which the medical device
is not to be used.

ISO 15223-1
Reference
no. 5.1.5

Medical devices — Symbols to
be used with medical device
labels, labelling and inform-
ation to be supplied.

Batch or Lot code

Indicates the man-
ufacturer's batch code so
that the batch or lot can
be identified.

Madsen A450

85

11 Standards and Safety

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Содержание Madsen A450

Страница 1: ...Madsen A450 Reference Manual Doc No 7 50 1840 EN 05 Part No 7 50 18400 EN...

Страница 2: ...Natus the Natus Icon Aurical Madsen HI PRO 2 Otoscan ICS and HORTMANN are registered trademarks of Natus Medical Denmark ApS in the U S A and or other countries Version release date 2021 06 10 221278...

Страница 3: ...7 3 1 Selecting a symbol or curve 28 2 7 4 Compare audiograms 29 2 7 5 Tone feature boxes 29 2 7 6 Tone editing options 31 2 8 Work flow related features 32 2 8 1 Selecting orientation 32 2 8 2 Automa...

Страница 4: ...le loudness level MCL 64 5 1 3 Assessing pure tone or speech uncomfortable loudness level UCL 64 5 1 4 Assessing speech reception threshold SRT using the Hughson Westlake procedure 65 5 1 5 Assessing...

Страница 5: ...ing 84 10 1 Powering 84 10 2 Software device communication 84 11 Standards and Safety 85 11 1 Madsen A450 85 11 2 Warnings cautions and notes 89 11 2 1 Connector warnings 89 11 2 2 General warnings 90...

Страница 6: ...a microphone Outputs Madsen A450 supports the following types of output Headphones Insert phones Bone conductor Sound field loudspeakers The speakers can use either the power amplifier built into Mad...

Страница 7: ...nting Viewing and printing test results Viewing the progression of a range of tests online Viewing historic audiometry results from NOAH or XML format Viewing online audiometry results during testing...

Страница 8: ...relevant and general safety aspects are described in Standards and Safety 85 Training It is recommended that you read this manual and try out test scenarios before you start operating Madsen A450 so t...

Страница 9: ...are able to respond to the stimuli User Environment Professional healthcare facility environment The system is intended for use in a quiet environment within normal office temperature humidity pressu...

Страница 10: ...ry module main window The basic Otosuite functions are described in the Otosuite User Guide Audiometry elements A Menu bar See the Otosuite User Guide B Audiometry toolbar Toolbar icons and menus 11 C...

Страница 11: ...rs in a single audiogram com bined audiogram or both a left and a right audiogram on your screen Combined View Click to view both ears in a single audiogram Split View Click to view separate audiogram...

Страница 12: ...have selected it in the transducer section of the Control Panel or with device controls if applicable and data points are entered on the audiogram 2 2 3 View menu Menu item Tone Icon Description Selec...

Страница 13: ...to toggle between viewing both ears in a single audiogram com bined audiogram or both a left and a right audiogram on your screen Audiogram Legend Click to enable or disable the display of the audiog...

Страница 14: ...e sensitivity and the output level in dB HL to the patient When enabled the monitor speaker will be disabled When the Allow stimulation checkbox is checked you can present stimuli while leaving Talk F...

Страница 15: ...at the patient is pressing the Patient Responder 2 4 The Masking Assistant If the Masking Assistant is enabled it will at all times check for frequencies that may require testing with masking This als...

Страница 16: ...y stored thresholds measured without masking are checked Levels which did not evoke a response are excluded from the check This means that as soon as a masked threshold has been stored the flashing st...

Страница 17: ...J W III Mueller G H III Munro Agnew BJA 1999 8000 42 Katz J Munro Agnew BJA 1999 Min IA insert phone Hz dB 125 60 N A traditional value 250 72 Munro Agnew BJA 1999 500 64 Munro Agnew BJA 1999 750 60...

Страница 18: ...e the Test Selector to quick select the relevant user test Right click on the buttons in the control panel to view the right click menu Click to enable or disable selections of your choice Right click...

Страница 19: ...selection Tone Warble FRESH noise Pulsed Test type selection AUD audiogram threshold curve SRT Speech Recognition Threshold WRS Word Recognition Score MCL Most Comfortable Loudness level UCL Uncomfor...

Страница 20: ...d dialog Enables communicating with the patient in the sound booth This will display the Talk Forward dialog box where you can control the talk forward microphone sensitivity and the output level in d...

Страница 21: ...ternal medium connected to the PC Speech Material Stim Lock presents stimulus and masker simultaneously Tracking increases stimulus and masker intensity by the same number of dB 1 dB Step 5 dB Step Cu...

Страница 22: ...y F Stimulus bar color G Routing indicator H Masking on Intensity Indicated by the dB level above the channel status bars Masking is denoted by square brackets around the level calibrated in effective...

Страница 23: ...left decreases the stimulus frequency Arrow right increases the stimulus frequency Stimulate button Present Tone Presents stimulus If Continuous On is enabled activating the button interrupts the stim...

Страница 24: ...ue in the center of the stimulus bar 2 6 3 The Speech stimulus bar A VU meter B Speech score C Word count During online testing the stimulus bar shows Speech Score Word Count Displays the percentage c...

Страница 25: ...B Audiometry toolbar C Stimulus bar D Control panel E Work area F Feature boxes 2 7 1 The work area in the Tone screen The Tone test work area consists of a range of elements for viewing and selectin...

Страница 26: ...cates where you place the mouse The color indicates the routing Blue left Red right Black binaural Audiogram Intensity is shown to the left of the audiogram in dB HL Octave frequencies are shown below...

Страница 27: ...cor respond to your viewing preference 1 Select Tools Options Tone Misc Dual Graph View or in the menu bar under View A Stimulus marker ear color B Masking level indicator Viewing masking levels Mask...

Страница 28: ...ed Condition The current symbols and line style are shown 3 Double click on the symbol you wish to change The Symbols selection dialog box is shown 4 Double click on the symbol you wish to use 5 To ch...

Страница 29: ...nhance the compare view by enabling the Difference view This is done by checking the Difference option in the fea ture box The Difference view highlights any difference between the most recent and any...

Страница 30: ...s well as the articulation index AI The AI is calculated according to the Count the dot method To configure PTA calculation select Tools Options General Miscellaneous PTA Method Selecting Average Sele...

Страница 31: ...lick on the main screen in Tone mode the following options appear Tone editing options Selected Point e g Left AC threshold 1kHz If more than one symbol is at the same intensity frequency select the d...

Страница 32: ...lick to select the way you view the patient in relation to your mon itor Control Click to select the position of the stimulus channel on the screen 2 8 2 Automatic frequency level shift when storing W...

Страница 33: ...ncy it goes to 1000 Hz and automatically selects the next lower frequency When it reaches the lowest frequency it automatically goes to 1000 Hz The direction depends on whether the previous data point...

Страница 34: ...on the fly use the control panel to select The predefined tests are incorporated as rows in the speech table To select a predefined test simply click the button in the Test column This will load all...

Страница 35: ...the table to a user test When you have pinned the new test rows to the speech table you must save it to a user test or to your start up settings Open the Tools Options dialog and click to save as a u...

Страница 36: ...scoring This means that you can click the scorable items directly in the speech list Scorable items can be either individual phonemes in phoneme scoring or individual words in sentence scoring You can...

Страница 37: ...is incorrect unless you manually score it as correct External speech material The percentage is calculated based on the total number of words you have defined in advance Tools Options Audiometry Spee...

Страница 38: ...without pausing External speech material Does not apply to external sound source speech material Phoneme Sentence scoring The word list is presented exactly as the original recording without pausing...

Страница 39: ...erial Autoscore Autoscore Word scoring When you score words Autoscore is defined by the combinations of the settings in the columns Counting and Playing If a word is not manually scored before Time ou...

Страница 40: ...section of the right click menu Combining Recorded Source A and Recorded Source B as Input sources in the control panel right click menu will replace the audi ometer speech masking with a recorded in...

Страница 41: ...rol Panel and browse to the folder where your recordings are stored CD material You can use any type of CD sound recordings of your choice Select Int CD in the Control Panel and browse to the drive yo...

Страница 42: ...test Scoring You can always click on any word to change the score The word that has just been played is also shown above the list so that you can easily score it Specific scoring Click on the word to...

Страница 43: ...ore the word scores See Storing speech data 35 2 9 5 Scoring words using external sound source Note Using an external sound source includes the use of all types of sound sources such as CDs MP3 player...

Страница 44: ...rect phonemes 0 1 phoneme correct 1 2 phonemes correct 2 All 3 phonemes correct 3 B Play Pause C Stop D Reset Counter scoring and Player E Previous next list F Speech material selection G File track l...

Страница 45: ...st You can also see the word currently being played back for monitoring purposes The number of correct phonemes repeated is marked with the corresponding number to the left of the word in the list The...

Страница 46: ...ine In is selected In the Speech Player Panel example shown above the Number of phonemes setting in the Scoring and Playing dialog box is set to 3 Setting up for Scoring and Playing To set up for scor...

Страница 47: ...Browse to the folder containing the WAVE wav file or files you wish to adjust to a specific level 2 Play the calibration file from the Speech player 3 Use the dials in the Monitor and Level section o...

Страница 48: ...time Sorting by ear is sometimes preferred when you compare the ears when analyzing the complete results To sort data by their sequential number click the number field in the table header marked with...

Страница 49: ...g Automatic is useful when you mix speech and noise from the two audiometer channels 2 9 11 Speech feature boxes You can access a number of speech display options directly from the Speech main screen...

Страница 50: ...ax time 79 9 NA 80 82 16 h 82 1 85 8 h 85 1 88 4 h 88 1 91 2 h 91 1 94 1 h 94 1 97 30 min 97 1 100 15 min 100 1 103 7 5 min 103 1 106 3 75 min 106 1 109 1 875 min 109 1 112 56 25 sec 112 1 115 28 13 s...

Страница 51: ...metry module Contact your local supplier for further information 2 10 2 SISI Short Increment Sensitivity Index The SISI Test was developed by Jerger and co workers Jerger Shedd and Harford 1959 and wa...

Страница 52: ...the tone automatically using the play button Options are 1 dB 2 dB and 5 dB Natus recommends using a step size of 1 dB for testing SISI Stimulus Bar A Intensity B Stimulus indicator C Transducer indic...

Страница 53: ...w right button increases the stimulus frequency Store Stores the data point Scoring Level Intensity Change Recognition Click the button each time the patient acknowledges that a change in intensity wa...

Страница 54: ...rise time of 50 milliseconds a dur ation at full strength of 200 milliseconds and a decay time of 50 milliseconds The size of the increment can be varied from 0 to 5 dB in 1 dB steps selected on scree...

Страница 55: ...nes Phone Presents the stimulus through the headphones High Frequency Presents the stimulus through the high frequency headphones Routing Left Left transducer is considered the ABLB test ear Right Rig...

Страница 56: ...the routing for each channel Test controls Test controls provide a means of operating the audiometer if you use the mouse and on screen options to perform tests To enable test controls select Tools Op...

Страница 57: ...sented to this ear until equal loudness with the reference ear is determined ABLB editing options Editing options Selected point Select the point that you would like to delete the selected measurement...

Страница 58: ...2 11 Test controls keyboard mouse 2 11 1 PC keyboard controls You can open an overview of PC keyboard shortcuts from the Otosuite Manuals file Otosuite Manuals was installed on your PC when you instal...

Страница 59: ...d This reduces the likelihood that the client patient can anticipate when the stimulus will be presented For pediatric testing consider using a highchair which is a familiar environment for most child...

Страница 60: ...nabled See Configuring the Audiometry Module 79 3 3 Listening check Perform listening checks routinely to make sure that the equipment is functioning properly Use a person who has auditory thresholds...

Страница 61: ...d right side Note If the headphones are not placed properly there is risk of causing the ear canal to collapse which will result in elevated thresholds 3 Ask the patient if the headphones are comforta...

Страница 62: ...t ear differ by 45 dB or more masking is needed Mastoid placement 1 Move any hair covering the mastoid out of the way and place the flat round part of the bone conductor securely on the boniest portio...

Страница 63: ...ansducer and desired routing sound level and frequency Make sure that threshold test THR is selected 9 Begin the test in the ear reported as the better hearing ear Tell the patient in which ear the te...

Страница 64: ...erlay options can be used for counseling the patient 24 Click in the Reliability box to report the reliability of the patient s responses during testing Good Fair or Poor 5 1 2 Assessing pure tone or...

Страница 65: ...Inform the patient in which ear the test will begin 5 Start presenting words at a level that should be clearly audible to the patient to confirm that the instructions for responding were understood 6...

Страница 66: ...g the buttons Typically 25 or 50 words are presented in a list Once all the words on the list have been presented you have a percentage correct This is the WRS Once the WRS is obtained store the respo...

Страница 67: ...te software is set to the correct transducer and desired routing fre quency and sound level Choose any frequency Set the level for the better ear at 10 dB above recorded threshold and set the level in...

Страница 68: ...right or both ears 3 Select Weber in the Test Selector Make sure that the control panel of the Otosuite software is set to the correct transducer and desired routing sound level and frequency 4 Make...

Страница 69: ...a change I will ask you if the test tone is softer than louder than or equal to the reference tone in the opposite ear 4 Choose the ABLB tab or select ABLB in the Test Selector Make sure that the con...

Страница 70: ...l combo box 3 If Int File is chosen select Sound File Selection in the Options dialog or browse for a folder containing sound files in the Player Panel This will list all sound files contained in the...

Страница 71: ...tton click will start to play back the word list from the current index to the end 4 If you like to change index during playback just change index in the Word list control and it will keep on playing...

Страница 72: ...ly installed and the requirements listed in Standards and Safety 85 and Technical specifications 93 must be complied with Caution The power supply should be kept away from the client area Warning Keep...

Страница 73: ...during transport 2 Visually inspect the equipment for possible damage If damage has occurred do not put the device into operation Contact your local distributor for assistance 3 Check with the packing...

Страница 74: ...tes 89 When you have connected the accessories configure your system setup To do so see Configuring the Audiometry Module 79 1 PC USB connection 2 External power supply 3 Sound field speakers power ou...

Страница 75: ...ll the mains plug out of the wall mains See Technical specifications 93 for details 1 Plug the external power supply into the Power socket in the connection panel 2 Plug the mains plug of the external...

Страница 76: ...ing a boom microphone with the operator monitor headset plug the boom microphone on the monitor headset into this socket The jack is marked with this symbol L Counseling and Simulations headphones Con...

Страница 77: ...50 and the PC Note Connection cables for accessories connected to Madsen A450 are not shown See Madsen A450 connection panel 74 Wall mount installation It is recommended that you connect the external...

Страница 78: ...et To disconnect Madsen A450 from the mains supply pull the mains plug out of the wall mains outlet Do not position the unit so that it is difficult to pull the mains plug out of the wall mains 1 Plug...

Страница 79: ...you have purchased additional Otosuite functions you will be prompted to enter the relevant license keys Test Type Show test type Click to enable viewing any of these test types as a test tab selecti...

Страница 80: ...Designation You can define how SRT data is stored in NOAH by selecting the appropriate type of speech material designation This enables proper viewing in NOAH AUD 80 Madsen A450 7 Configuring the Aud...

Страница 81: ...ecting to the device If communication with Madsen A450 is interrupted a message appears stating that there is no longer connection to the device The system will automatically try to reconnect If autom...

Страница 82: ...nnel at authorized workshops In case of any defects make a detailed description of the defect s and contact your supplier Do not use a defective device Note There are no user serviceable parts inside...

Страница 83: ...cer to your audiometer 2 Connect the audiometer to your Otosuite PC 3 Insert the USB memory stick in an empty slot on your PC 4 Call your Natus technical support team They will use the application Tea...

Страница 84: ...e was installed An extended version of data sets has been installed with the new version of Otosuite Accept the error message This message only appears the first time the new version of Oto suite is l...

Страница 85: ...Regulation and other applicable Union harmonisation legislation providing for its affixing ISO 15223 1 2016 Refer ence no 5 1 1 ISO 7000 3082 Medical devices Symbols to be used with medical device la...

Страница 86: ...rm ation to be supplied Part 1 General requirements Keep dry Keep away from rain Indicates a medical device that needs protection from moisture ISO 15223 Keep dry ISO 7000 Keep away from rain ISO 1522...

Страница 87: ...use Oper ator s manual operating instruc tions Indicates the need for the user to consult the instruc tions for use ISO 15223 1 Clause 5 4 4 ISO 60601 1 Table D 1 symbol 10 Medical devices Symbols to...

Страница 88: ...3 Medical electrical equipment Part 1 General require ments for basic safety and essential performance Type BF Applied Part To identify a type BF applied part complying with IEC 60601 1 EC 60601 1 Ref...

Страница 89: ...h ANSI AAMI ES60601 1 2005 R 2012 IEC 60601 1 6 CAN CSA C22 2 No 60601 1 14 CAN CSA C22 2 No 60601 1 6 INMETRO in conjunction with the Mark of the National Institute of Met rology Standardization and...

Страница 90: ...emperatures and humidity exceeding those stated in the Tech nical Specifications Transport and Storage and Operating Environments Warning Make sure that the total length of the USB cable used does not...

Страница 91: ...inter must be placed out of reach of the patient i e not closer than approx 1 5 meters 5 ft Warning Any PC connected to the device must comply with the requirements of IEC 62368 1 2020 Warning The use...

Страница 92: ...Do not use the device if the packaging is damaged 11 2 4 General notes Note It is recommended to install the device in an environment that minimizes the amount of static electricity For example anti...

Страница 93: ...range for SF 125 8000 Hz Accuracy 0 3 Narrow Band Noise masking Available for each stimulus frequency Frequency resolution 125 to 8000 Hz at standard frequencies Stimulus types Tone Warble Pulsed tone...

Страница 94: ...0 6000 8000 9000 10000 11200 12500 Offset dB N A 53 37 32 31 29 30 29 27 31 27 26 26 25 25 This table indicates the number Offset to be added to the displayed masking level in order to calculate the s...

Страница 95: ...conductor output is not corrected to obtain a free field equivalent sound force level uncorrected output meas ured by an artificial mastoid IEC 60318 6 is produced Calibration of speech signals is per...

Страница 96: ...lowed THD 125 250 75 65 2 5 315 400 90 80 2 5 500 5000 110 100 2 5 Specification of allowable distortion levels for bone conducted sound test level and distortion Frequency Hz Test level for bone vibr...

Страница 97: ...shall be applied HB8 is in compliance with ISO 389 For children and below normal skull size HB7 shall be applied HB7 provides a greater force required to accommodate smaller skull size For audiometri...

Страница 98: ...2 x 1 6 Vrms External inputs CD Analog line in 0 2 to 2 0 Vrms 10 k 1 stereo 3 5 mm 1 8 inch jack Talk Back microphone Electret microphone Input voltage 0 002 to 0 02 Vrms Input resistance 2 21 k 3 5...

Страница 99: ...imum output may be set lower than the physically available output level installation option As the maximum available output level will result in significant distortion from the bone conductor the spec...

Страница 100: ...0 C to 60 C 22 F to 140 F Air humidity 10 to 90 non condensing Air pressure 50 kPa to 106 kPa Operating environment Mode of operation Continuous Temperature 15 C to 35 C 59 F to 95 F Air humidity 20 t...

Страница 101: ...EN 60601 1 2 2007 IEC 60601 1 2 2014 and EN 60601 1 2 2015 12 1 Accessories Standard accessories and optional accessories may vary from country to country please consult your local distributor Madsen...

Страница 102: ...terial CD US Speech Material 8 49 89200 1066 Speech Material CD CN Speech Material 8 49 88200 1066 Speech Material CD UK Speech Material 8 49 88300 1066 Speech Material DVD DE Speech Material 8 49 884...

Страница 103: ...00917 International Matrix Test Italian Speech Material 22600918 International Matrix Test French Speech Material 22600919 International Matrix Test Hebrew Speech Material 22600920 International Matri...

Страница 104: ...estic purposes Harmonic emissions IEC 61000 3 2 Not applicable Voltage fluctuations flicker emissions IEC 61000 3 3 Not applicable Guidance and manufacturer sdeclaration electromagnetic immunity for a...

Страница 105: ...t and systemswithin Professional Healthcare use environment Madsen A450 is intended for use in the electromagnetic environment specified below The user of Madsen A450 should ensure that it is used in...

Страница 106: ...t 8 kV air Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humid ity should be at least 30 Electrical fast transient burst IEC 61000 4 4 2 kV...

Страница 107: ...he higher frequency range applies Note 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people a Fiel...

Страница 108: ...nded separation distance d in meters m can be estimated using the equa tion applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W acco...

Страница 109: ...s or repairs are carried out by the equipment man ufacturer or personnel authorized by the manufacturer The electrical installation to which the equipment is connected complies with the requirements s...

Страница 110: ...13 Manufacturer 110 Madsen A450...

Страница 111: ...ons bone oscillator 75 CD tape 76 Counseling and Simulations head phones 76 external power supply 75 headphones 75 insert earphone 75 operator boom microphone 76 operator headphone 76 patient responde...

Страница 112: ...Navigating in Audiometry 63 O On screen controls 23 Operator boom microphone con nection 76 Operator headphone connection 76 OTOsuite main window 10 menu bar 11 the user interface 10 Overlays feature...

Страница 113: ...93 Test devices connecting 81 information about 81 views 73 Test devices Audiometry firmware update 81 Tests Speech screen 34 Tone screen Audiogram Module 25 Timer feature box Feature box Timer 30 Ton...

Страница 114: ...Views of the device 73 W Warning notes 89 Weber 68 feature box Feature box Weber 30 114 Madsen A450 Index...

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