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6 Introduction

1.3 Intended use

Name:

ATMOS

Audio Cube 31

Main function:

Quantitative and qualitative electro-acoustics hearing test

Medical indications / application:

Test and determination of the hearing ability

Specification of the main function:

Determination of the hearing ability (tone and

speech audiometry, suitable for the diagnostic and clinical application).

Application organ:

Ear

Application time:

For the short-term application on patients (max. 60 minutes).

Application site:

In clinics and practices for ENT doctors. The examination may only be

performed by healthcare professionals.

Contraindications:

None

The product is:

active

Sterility:

Not necessary

Single-use product / reprocessing:

No single use product

1.4 Function

Principle:

Audiometry is the subjective examination of the hearing ability, for which

there are several different methods. Unlike objective audiometry (tympanography/OAE/

BERA) the active cooperation of the person to be examined is required. The audiometric

tests are performed in a soundproof room.

Measuring method:

The ATMOS

Audio Cube 31 applies the tone and speech audiome-

try by means of air and bone conduction as well as in the free field.

Tone audiometry:

The auditory threshold is determined with a tone audiogram. The

patient is presented with tones of different frequencies. The volume of the tone is grad-

ually increased until the patient can perceive the tone, the so-called threshold. Initially

this test is performed by means of air and then by bone conduction. Together the result

is the tone audiogram.
Now it can be determined whether there is a conductive hearing loss (hearing defect in

the middle ear) or a sensorineural hearing loss (hearing defect in the inner ear) or if it is

a combination of both. If there is a difference in hearing between both sides, masking is

required for the non-test ear.
All the important supra-threshold tests are integrated in the ATMOS

Audio Cube 31,

they indicate in which part of the acoustic organ of the inner ear damage exists.

Speech audiometry:

Speech audiometry is not only the hearing of tones but also the

perception of complex acoustic information e.g. words, numbers or sentences which the

patient must then repeat.
Country-specific speech tests can be used via a CD or hard disk.

Significance:

From the combination of sound and speech audiometry, the doctor knows

in which frequency ranges the patient has hearing problems and what therapeutic

approaches have to follow from them.
The measurement of the tone and speech audiometry together with the measurement

of the otoacoustic emissions (OAE) and the derivation of acoustically evoked potentials

(BERA) as well as the tympanometry with a stapedius reflex measurement allow a

precise clarification of the hearing. With the help of these tests it is possible to elicit the

location, type and extent of a hearing loss.
The measurement results can be saved in a patient related database, be printed or

integrated into a doctor's practice software system respectively into a hospital informa-

tion system (HIS).

Содержание Audio Cube 31

Страница 1: ...Operating Instructions ATMOS Audio Cube 31 English 0483 GA1GB 140201 0 2017 12 Index 02 ...

Страница 2: ...ting room 16 3 9 Installation of the ATMOS Audio Cube 31 software 16 4 Operation 18 4 1 Ambient conditions during operation 18 4 2 Switching on the device 18 4 3 Switching off the device 18 4 4 Patient management with the ATMOS PatSoft 31 18 4 4 1 Starting the ATMOS PatSoft 31 18 4 4 2 Exit the ATMOS PatSoft 31 18 4 4 3 Recommended procedure at workplaces 18 4 4 4 Go to a section 18 4 4 5 Create a...

Страница 3: ...unction check 36 6 3 Weekly function check 37 6 4 Metrological check electrical safety 38 6 5 Parts replacement 39 6 5 1 Sennheiser HDA280 headphone cushions 39 6 5 2 Sennheiser HDA280 headphone bow cushion 39 6 5 3 Head bow of the bone vibrator B71 39 6 5 4 Bone vibrator cable B71 40 6 5 5 Mains fuses 40 6 6 Sending in the device 40 7 Troubleshooting 41 8 Accessories 42 9 Spare parts and consumab...

Страница 4: ...oduct To carry out these measures the person must have the necessary test devices and original spare parts Peruse chapter 2 Hints for your safety on page 8 before using the device for the first time This helps you avoid potentially dangerous situations The product ATMOS Audio Cube 31 bears CE marking CE 0483 accord ing to the EC Directive of the council for medical products 93 42 EEC and meets the...

Страница 5: ...ation on the handling of the device 1 Action Go step by step Numeration Result of an action On device and type plate Application part type B This product complies with the relevant requirements of EU Directives SN Serial number Observe operating instructions REF Order number Manufacturing date Professional disposal Manufacturer 1 WARNING Danger of fatal injury from electric current Please observe ...

Страница 6: ...old Initially this test is performed by means of air and then by bone conduction Together the result is the tone audiogram Now it can be determined whether there is a conductive hearing loss hearing defect in the middle ear or a sensorineural hearing loss hearing defect in the inner ear or if it is a combination of both If there is a difference in hearing between both sides masking is required for...

Страница 7: ... and Storage Transport at low temperatures can damage the device 1 Prior to start up the unit must acclimatize for up to 6 hours at room temperature Transport the device only in a shipping carton which is padded and offers suﬃcient protection If damage occurs during transport 1 Document and report the damage to ATMOS 2 Fill in the form QD 434 customer complaint return shipment This is enclosed to ...

Страница 8: ... remove the transducer from the patient or examiner Plug out the transducer before you repair it First remove the transducer cable from the audiometer before you loosen the cable from the transducer itself Do not operate the device if it has been dropped In this case clean the device and send it in to ATMOS for repair Only connect the device to a power supply with a correctly installed protective ...

Страница 9: ...ontact ATMOS Please pay attention to the period tests in chapter 6 1 Period tests on page 35 Only use original accessories and original spare parts from ATMOS Assembly new settings modifications extensions and repairs may only be carried out by persons who are authorized by ATMOS Only a fully functional product meets the safety requirements of users patients and third parties Therefore read the fo...

Страница 10: ... 3 4 Connection diagram on page 12 3 2 System requirements Inappropriate hardware The patient cannot be examined and treated Observe the minimum requirements for the hardware Operating system Windows Vista 7 8 Free hard drive capacity min 50 GB CPU performance min 2 GHz Available RAM min 4 GB RAM Graphic resolution min 1600 x 900 Connections min 1 USB connection further USB interfaces for printer ...

Страница 11: ...Never place the device in direct sunlight beside radiators in poorly ventilated rooms or in damp rooms 3 3 1 Audiometer with free field loudspeaker Please observe the following standards DIN EN ISO 8253 2 July 2010 Acoustics Audiometric test methods Part 2 Sound field audiometry with pure tone and narrow band test signals DIN EN ISO 8253 3 August 2012 Acoustics Audiometric test methods Part 3 Spee...

Страница 12: ...icro phone Headset Stereo Red connector The microphone in the front panel is automatically switched off as soon as a headset is plugged in 10 Monitor ear phone stereo Headset Stereo Green connector If the monitor earphone Mono is simultaneously plugged in the left side of the head set does not function 11 Monitor ear phone mono Control earphones Mono The left side of the head set is switched off 1...

Страница 13: ...ply with IEC 60601 1 observe the following The devices must be powered via an isolation transformer or power supply unit which complies with IEC 60601 1 The devices must comply with EMC standards Connecting the system 1 Observe the notes in this chapter 2 Connect the device 3 Ensure that it does not present a tripping hazard e g cables multiple socket etc 4 Protect the connecting cables between th...

Страница 14: ...dministratOr 4 If you are requested enter your administrator login details The software starts 5 Set the following Language Installation path Software to be installed Depending on the software the programme automatically selects the necessary software components driver 6 Click on the button installieren install The software will be installed The current status is displayed at the bottom left As so...

Страница 15: ...start window After opening the PatSoft 31 you can select which section should be displayed 1 Go to the section OptiOns 2 Click on the tab general 3 Select in this section the requested start screen under start sCreen Depending on the workplace situation ATMOS recommends you to select the following start window Reception table all patients Treatment room Waiting rOOm ...

Страница 16: ...er how many hours the patient data in the section waiting room should be highlighted in yellow Maximum amount of patient data 1 Select in the text field maximum patients in Waiting rOOm the maximum amount of patient data which should be in the section waiting room 3 9 Installation of the ATMOS Audio Cube 31 software User and practice data 1 Click the button OptiOns The window Options is opened 2 1...

Страница 17: ...starting up 4 If required select the praxis logo in the format bmp or jpg 3 5 Enter the practice address 4 The practice information appears on the printout 6 Click the button OK The entries are saved The window is closed ...

Страница 18: ...t the PatSoft 31 over an icon on the desktop 1 Start the PatSoft 31 over the Windows menu start all programmes The PatSoft 31 is started 4 4 2 Exit the ATMOS PatSoft 31 1 Click on the button Exit above right red X The PatSoft 31 is closed 4 4 3 Recommended procedure at workplaces ATMOS recommends that at the workplace reception the patient data is imported created processed searched and stored in ...

Страница 19: ...he tab neW 3 Go to the section neW patient and enter the patient data 4 Save the data by clicking on the button save 4 4 6 Importing patient data manually 1 Go to the section table all patients or in the section edit patient data 2 Click the button impOrt The patient data will be updated ...

Страница 20: ...n edit patient data In the section EDIT PATIENT DATA 1 Go to the section edit patient data 2 Go to the tab searCh 3 Enter in the section searCh the patient data which you are searching for As soon as you enter the first character a corresponding hit will be highlighted in the chart If you want to edit the patient data click on the button edit patient data 4 4 8 Editing patient data 1 Go to the sec...

Страница 21: ...tton abOrt 4 4 9 Place the patient data in the section WAITING ROOM 1 Go to the section table all patients or in the section edit patient data 2 Find for the patient data in the section searCh 3 Double click on the desired patient data 4 Click on the button add tO Waiting rOOm The patient data is available in the section Waiting rOOm ...

Страница 22: ...rent patient 3 Click on the relevant diagnostic software button which you would like to use The diagnostic software starts The patient data is automatically adopted 4 4 11 Remove the patient data from the waiting room 1 Double click on the desired patient data 2 Click on the button remOve FrOm the Waiting rOOm The patient data is deleted from the section Waiting rOOm 4 5 ATMOS Audio Cube software ...

Страница 23: ... for measuring Transducer which is used for the test Settings for mask ing Tone audiometry Speech audiometry Speaking to the patient High tone measurement Level increment Tone audiometry Set the type of signal Speech audiometry Select speech test Activate additional tests 6 Operation New measurement Save measurement as a PDF Diagnosis enter the findings from the measurement Start patient managemen...

Страница 24: ...rements you may create standardized selection texts 1 Click the button Options The window Options is opened 2 Select the tab Diagnosis 3 Enter the available texts for diagnosis and findings 4 Click the button OK The entries are saved The window Options is closed Software representation measurement settings 1 Click the button Options The window Options is opened 2 Select the tab Representation Furt...

Страница 25: ...subject to data security evidence for the health insurance If the audiometer software is not integrated in a practice software then the patient data must be managed via the audiometer software If the audiometer software is integrated in a practice software then the patient manage ment of the audiometer software is blocked Selecting a patient 1 Click on the button patient in the main window to open...

Страница 26: ... The patient data appears in the top of the main window Changing or deleting a patient The patient number cannot be changed 1 Click on the button patient in the main window to open the patient management 2 Select the patient 3 Click on the tab change 4 Change the patient data 5 Click on the button save to save the changes 6 If you want to delete the patient data Click on the button delete 4 5 4 Pr...

Страница 27: ...ight ear 2 Press the arrow key to the right or left to adjust the first frequency The arrow key is either on the keyboard or on the centre of the display The software displays the current set frequency 3 Change the level by pressing the arrow key up down The arrow key is either on the keyboard or on the top left of the display Increase the level gradually 4 As soon as the patient activates the pat...

Страница 28: ...The arrow key is either on the keyboard or on the top left of the display Increase the level gradually 4 As soon as the patient repeats the text press Correct or Incorrect The software marks the comprehensibility quote at each level 5 By doing so you can check all the desired texts 6 Continue with the left ear Please note Please note you can change the level with the key piCture and piCture 4 5 7 ...

Страница 29: ...Chapter Comments on page 29 If you have loaded several measurements you cannot comment on them Therefore load the measurements individually 1 Click on the button Comment The comment window is opened 2 Enter the diagnosis and or findings 3 Click the button OK The comments are saved Storage Measuring data can only be stored when it is assigned to a patient 1 Click on the button Save The measurement ...

Страница 30: ...rements simultaneously if you keep the STRG key pressed and click on the measurement 5 Click the button OK The measurement is displayed in the main window Delete 1 Select a patient 2 Click the button Load The Load window is opened Only measurements regarding the selected patient will be displayed 3 Navigate with 4 Select the measurement by clicking on it 5 Click on the button Minus 6 Confirm the q...

Страница 31: ...31 Operation Export 1 Click the button PDF The PDF is opened 2 Save the PDF Print 1 Click the button Print The printer dialogue is opened 2 Select printer settings 3 Print the document ...

Страница 32: ...ted the device it may no longer be operated In this case clean the device and send it in to ATMOS for repair Observe the operating instructions of the disinfectant manufacturers Note in particular the information on the concentration and material compatibility Only use disinfectants which are recommended by ATMOS chapter 5 3 Recom mended disinfectants on page 33 The use of other disinfectants may ...

Страница 33: ...nts If you are using aldehyde and amine containing disinfectants on the same object this may cause discolouration Housing damage due to unsuitable detergents Corrosion damage and stress cracks are possible Only use the recommended disinfectant or disinfectant solutions with the same ingredients Do not use disinfectants containing alcohol Do not use disinfectants containing organic and inorganic ac...

Страница 34: ...derstedt Terralin Protect Application concen trate Benzyl C12 16 alkyldimethyl chloride 22 g Schülke Mayr Norderstedt 2 phenoxyethanol 17 g aminoalkylglycine 0 9 g non ionic surfactants perfumes Mikrobac forte Application concen trate benzyl C12 18 alkyldimethyl ammonium chlorides 19 9 g Bode Chemie Hamburg N 3 aminopropyl N dodecylpropane 1 3 di amine 5 g ...

Страница 35: ... shock Cardiac arrhythmia is possible Incorrect measurement results Patients hearing can be damaged Please observe the deadlines in this chapter If you notice any errors or defects on the audiometer Please contact ATMOS Mandatory test Period Tester Daily function check Daily prior to use User Weekly function check Every week When the device is rarely used prior to each use User Metrological check ...

Страница 36: ...vice 3 Wait for at least 5 minutes The device must warm up Checking tone audiometry 4 Check subjectively the hearing threshold via air conduction and bone conduction The hearing threshold is within normal limits 5 Test the following conditions of the air conduction and bone conduction No disturbing noises no signal from other channels no difference in the tone quality when the masking noise is swi...

Страница 37: ...dB splitter without mechanical and electrical noises Tone switch mute button mechanically silent The emitted noise from the audiometer cannot be heard by the test person 5 Test the following condition at 60 dB HL air conduction and 40 dB HL bone conduc tion Proper function on both sides of the headphone free field speakers and bone vibrator by all frequencies and settings distortion free no switch...

Страница 38: ...ill be tested within the metrological check Visual check wear parts will be replaced Function check Patient probe and patient communication test Disturbing noise cross talk distortion test Pressing force of the headphones Frequency accuracy of the test tone Total harmonic distortion THD of the air conduction Tone level attenuation Deviation of the sound pressure level tone and noise masking per se...

Страница 39: ...remove from the ear piece 3 Replace with new cushions 6 5 2 Sennheiser HDA280 headphone bow cushion 1 Switch off the device 2 Open the fastener on the cushion and remove from the bow 3 Replace the cushion onto the bow with the opening turned upwards 4 Pull both fastener sides together until they overlap 5 Press them together 6 5 3 Head bow of the bone vibrator B71 1 Switch off the device 2 Unclip ...

Страница 40: ...e 3 Loosen the top and bottom of the fuse holder with a screwdriver 4 Remove the fuse holder 5 Replace both glass tube fuses 6 Reattach the fuse holder Press until it audibly locks 6 6 Sending in the device 1 Remove and properly dispose of consumables 2 Clean and disinfect the product and accessories according to the operating instruc tions 3 Place used accessories with the product 4 Fill in the f...

Страница 41: ...ble cause Remedy Measurement does not start No USB connection between PC and audiom eter 1 Check whether the PC is connect ed to the device 2 If necessary connect the PC and ATMOS Audio Cube 31 with the USB cable The software does not respond Patient management window is still open in the background 1 Keep the Alt and Tab keys pressed and select the patient manage ment with the arrow 2 Close the p...

Страница 42: ...In this case please contact ATMOS Free field loudspeakers must always be calibrated on site In this case please contact ATMOS Accessories REF Patient microphone 512 2118 0 Cable harness acoustic booth 512 2114 0 Loudspeaker active 512 2115 0 Loudspeaker cable 2m 512 2116 0 Loudspeaker cable 3m 512 2117 0 Option high tone audiometry incl headphones HDA 300 512 2120 0 Free field loudspeakers must al...

Страница 43: ...280 headphone cushions 512 2123 0 Sennheiser HDA 300 headphone cushions 512 2124 0 Sennheiser HDA 280 HDA 300 headphone bow cushion 512 2122 0 Replacement headband Sennheiser HDA 280 512 2125 0 Head bow bone vibrator B71 512 2121 0 Patient response button 512 2112 0 Headset Stereo 512 2113 0 ...

Страница 44: ...spose of the device professionally Disposal within the EC 1 Clean and disinfect the device 2 The product may not be disposed of over the domestic waste EC Directive WEEE and RoHS 3 Dispose of the device professionally and according to country specific regulations Disposal in countries which do not belong to the European Union 1 Clean and disinfect the device 2 Please note the country specific regu...

Страница 45: ...Headphone audiometer headphone Bone vibrator Free field 2 loudspeakers active or passive External further headphones or earphones or 2 other loudspeakers Monitor Mono monaural listener Monitor Stereo binaural listener Signal inputs Left and right external signal source Microphone external Headset electret or dynamic Microphone patient Patient microphone electret or dynamic Data interface RS 232 Pr...

Страница 46: ...test any connectable signal source Supra threshold tests SISI FOWLER Lüscher Langenbeck Stenger and Tinnitus Output level max 120 dB HL Bone vibrator B 71 Pressing force 5 4 N Coupling type IEC 373 Headphone Sennheiser HDA 280 Pressing force 5 0 N Coupling type IEC 303 Protection class I Applied part Type B Operation mode Continuous operation Type of protection IPX0 Classification according to App...

Страница 47: ...ron ment specified below The customer or user of the audiometer should ensure that it is used in such an environment Emissions Test Compliance Electromagnetic Environment Guidance RF Emissions acc to CISPR 11 Group 1 The audiometer uses RF energy only for its internal function Therefore its HF emissions are very low and it is unlikely that nearby electronic devices will be affected RF Emissions ac...

Страница 48: ...ent Surges IEC 61000 4 5 1 kV differen tial mode 2 kV com mon mode 1 kV differen tial mode 2 kV com mon mode The quality of the supply voltage should correspond to a typical commercial or hospital environ ment Voltage Dips Dropout IEC 61000 4 11 5 UT 95 Dip of the UT for Cycle complies The quality of the supply voltage should correspond to a typical commercial or hospital environ ment If the user ...

Страница 49: ... cases The emanation of electromagnetic waves is affected by absorption and reflection of buildings objects and people a The field strength of stationary transmitters such as base stations of cellular phones and mobile terrain radio equipment amateur radio transmitters cbm broadcast and TV stations cannot be predestined exactly To determine the electromagnetic environment in regard to stationary t...

Страница 50: ... For transmitters for which the maximum nominal output is not indicated in the above table the recommended safety distance d in meters m can be determined using the equation belonging to the respective column whereas P is the maximum nominal output of the transmitter in watts W acc to manufacturer s specification NOTE 1 With 80 MHz and 800 MHz the higher frequency range applies NOTE 2 These guidel...

Страница 51: ...51 For your notes 13 For your notes ...

Страница 52: ...ATMOS MedizinTechnik GmbH Co KG Ludwig Kegel Straße 16 79853 Lenzkirch Germany Phone 49 7653 689 0 atmos atmosmed de www atmosmed com ...

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