Madsen OTOflex 100 User Manual
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Madsen OTOflex 100 User Manual

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User Manual
Part No. 7-50-00000
Doc. No. 7-50-0000/U2

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  • Page 1 User Manual Part No. 7-50-00000 Doc. No. 7-50-0000/U2...
  • Page 2 Copyright notice No part of this User Manual or program may be reproduced, stored in a retrieval system, or trans- mitted, in any form or by any means, electronic, mechanical, photocopying, recording, or other- wise, without the prior written consent of GN Otometrics A/S. ©...

  • Page 3: Table Of Contents

    2.5.2 Powering the OTOflex 100 ................... 16 2.5.3 The charger........................17 2.5.4 Connecting the OTOflex 100 probe and insert phone ..........18 Display & keypad ........................21 2.6.1 Keys, terms, functions ....................21 2.6.2 Entering and editing data and settings............... 21 Device setup..........................
  • Page 4 Hygienic precautions..................... 23 Preparing the probe ........................23 3.2.1 Preparing for screening ....................23 3.2.2 Preparing for diagnostic and clinical testing............... 25 Preparing the OTOflex 100 ....................... 26 3.3.1 Probe test........................26 3.3.2 Fitting the eartip on the probe ..................27 3.3.3 Selecting a patient ......................
  • Page 5 Cleaning and disinfecting the probe tip..............58 8.3.4 Cleaning and disinfecting the test cavity ..............61 8.3.5 Changing the acoustic filter ..................61 8.3.6 Cleaning the OTOflex 100 .................... 62 8.3.7 Eartips ..........................63 8.3.8 Disposal of disposable articles..................63 8.3.9 Batteries and charger....................
  • Page 6 OTOflex 100 - User Manual 11.1.1 Compliance measuring system ..................73 11.1.2 Acoustic Reflex ......................73 11.1.2.1 Contra lateral Stimulation................73 11.1.2.2 Ipsilateral Stimulation ................74 11.1.3 Air pressure system ....................... 74 11.1.4 Data interface........................ 74 11.1.5 Type identification ......................75 11.1.6 Power supply .........................

  • Page 7: Introduction

    This makes it ideal for use with children and adults. The OTOflex 100 can be configured for a wide variety of tests, and it can be operated entirely manually or programmed for the user’s own combination of manual and automatic operation.

  • Page 8: The Otodiagnostic Suite Pc Software

    10.2, ‘Warning notes” on page Training It is recommended that you read this manual before you start oper- ating the OTOflex 100 so that you become familiar with the device before testing on a patient. Maintenance and cleaning For instructions on how and when to clean the OTOflex 100, please Chapter 8, “Service and Maintenance”...

  • Page 9: Typographical Conventions

    Typographical conventions 1.4.1 The use of WARNING, CAUTION and NOTE For safety reasons and appropriate use of the OTOflex 100, the man- ual contains WARNINGS, CAUTIONS and NOTES, which you should read carefully. The use of these is defined as follows:...
  • Page 10 User Manual OTOflex 100 GN Otometrics A/S...

  • Page 11: When You Receive The Otoflex 100

    If your package is incomplete, contact your supplier. Storing the OTOflex 100 If you need to store the OTOflex 100 before you put it into operation, follow the guidelines below: • Store the OTOflex 100 and accessories in the box provided to protect the equipment from damage.

  • Page 12: Views Of The Otoflex 100

    User Manual OTOflex 100 Views of the OTOflex 100 This section provides you with views of the OTOflex 100 and its charger from various angles. You will find a description of the keypad, and how to navigate and enter data in the OTOflex 100 in Section 2.6, ‘Display &...

  • Page 13: Bottom View

    OTOflex 100 User Manual 2.3.3 Bottom view Battery casing with cover Charger cavity 2.3.4 Reverse side view Probe mounted with short cable Track for probe cable Label Label GN Otometrics A/S...

  • Page 14: The Charger

    User Manual OTOflex 100 2.3.5 The charger Front view Charger tab for the device Charging diode Probe test cavity Base Rear view Mains socket GN Otometrics A/S...

  • Page 15: Probe

    Chapter 11, “Technical Specifications” on page 73 must be complied with. The OTOflex 100 can be used as a handheld device with no specific requirements to location. However, keep the OTOflex 100 away from all liquids and sources of heat (for detailed specifications, see Section 11.4, ‘Operating environment”...

  • Page 16: Powering The Otoflex 100

    The first time you insert the batteries, take out the battery cover from the bottom of the OTOflex 100: To do so, hold the device in one hand and pull on the slip attached to the battery cover.

  • Page 17: The Charger

    The next time you change batteries, press the cover inwards and upwards until it is released and snaps out of place. Battery status When the OTOflex 100 is powered on, it shows the current status of 100% 60% the battery in the top right corner of the display.

  • Page 18: Connecting The Otoflex 100 Probe And Insert Phone

    (see below) and plug the other end into the power outlet. The OTOflex 100 can be used immediately when you place it in the charger. When the OTOflex 100 is placed in the charger, you can follow the status of the charging process on the charging diode on the charger front.
  • Page 19 OTOflex 100 User Manual Plug the probe and/or insert phone plugs into the sockets on top of the OTOflex 100 (see the illustration below). Do not use force when you insert the plug. The Ipsi probe The plug of the Ipsi probe goes into the probe socket. Make sure that you insert the pin for the pneumatic pump into the pneumatic connection.
  • Page 20 If required, remove the probe from the probe fixture. Remove the probe fixture from the OTOflex 100. To do so, press the wings of the probe fixture gently towards each other, and ease the fixture out of its groove.

  • Page 21: Display & Keypad

    User Manual Display & keypad 2.6.1 Keys, terms, functions To operate the OTOflex 100, hold it with one hand (left or right). Use your thumb to press the buttons on the keypad and turn the scroll wheel. Soft keys The current functions of the two softkeys are displayed at the bottom of the display.

  • Page 22: Device Setup

    Section 5.1.1, ‘Chang- ing measurement settings” on page Device setup When you have installed the OTOflex 100, there are a number of de- vice settings you can customise to accomodate your use of the de- vice. To do so see Section 5.2, ‘Device settings”...

  • Page 23: Preparing For Testing

    For instructions on how to plug in the probe cable in the OTOflex 100, see Section 2.5.4, ‘Connecting the OTOflex 100 probe and insert phone” on page 3.2.1 Preparing for screening The probe with the short cable is best suited for screening purposes.
  • Page 24 OTOflex 100 Probe fitted on the OTOflex 100 cap You can fit the probe directly on the cap of the OTOflex 100, where the cable is folded into the cable track on the back of the OTOflex 100. Probe and OTOflex 100 with handgrip You can use the probe with the handgrip fitted on the OTOflex 100.

  • Page 25: Preparing For Diagnostic And Clinical Testing

    The probe with the long cable is best suited for diagnostic and clini- cal test purposes. The probe is connected directly to the OTOflex 100 via the cable. This allows for placing the OTOflex 100 near the patient, or for using it wall-mounted in a fixed position.

  • Page 26: Preparing The Otoflex 100

    Preparing the OTOflex 100 Press the On/Off key on the keypad to switch on the OTOflex 100. Wen you switch on the OTOflex 100, the test screen you have selected in “Default test” in Section 5.3, ‘Sequence setup” on page 51 will appear.

  • Page 27: Fitting The Eartip On The Probe

    OTOflex 100 User Manual Insert the probe tip in the test cavity on the charger. Probe test cavity Press Start to start the test. The probe is then tested, and a message will appear to state whether the probe is OK.

  • Page 28: Selecting A Patient

    If the patient does not appear on the list, you can enter the patient manually or identify the patient with a voice note (see ‘‘Adding a new patient” on page 29). Stand-alone If you are using the OTOflex 100 as a stand-alone device, the list GN Otometrics A/S...

  • Page 29: Selecting The User

    When you have entered the appropriate data, press Save. 3.3.4 Selecting the user If several users are using the OTOflex 100, you can select the appro- priate user for the session. • Scroll to the User icon on the main screen and press Select. A list of users appears.

  • Page 30: Selecting The Test Type

    3.3.5 Selecting the test type Note: The tests available depend on the configuration of your OTOflex 100. Scroll to select the Test icon on the Main Menu and press Scroll to the appropriate test type and press Select. Preparing the patient Position the patient so that you can easily access the ear to be tested.

  • Page 31: Selecting The Ear And Fitting The Probe With Eartip In The Ear Canal

    If you have not already done so, select the Patient icon on the OTOflex 100. A list of patients appears. Select the appropri- ate patient. Toggle the Ear selection key on the keypad until the Ear icon on the display shows the correct ear.
  • Page 32 User Manual OTOflex 100 GN Otometrics A/S...

  • Page 33: Tests

    OTOflex 100 User Manual Tests With the OTOflex 100 you can perform a range of middle ear tests, which are divided into the following major categories: Tympanometry • Section 4.2.1, ‘Tympanometric sweep” on page Reflex Testing • Section 4.3.1, ‘Acoustic Reflex Threshold” on page •...

  • Page 34: Tympanometry

    User Manual OTOflex 100 Section 5.1.3, ‘Tympanometric settings” on page Section 5.1.4, ‘Reflex Threshold settings” on page Section 5.1.5, ‘Reflex Decay settings” on page If you do not want to change the basic default settings, go to Section 4.2.1, ‘Tympanometric sweep” on page Section 4.3.1, ‘Acoustic Reflex Threshold”...
  • Page 35 OTOflex 100 User Manual the current test, and are not stored in the measurement settings set- To access these settings press Select, and scroll to the bottom of the Menu list, where these settings and functions are listed. With this test you can change the pump pressure and volume set- tings during the test.

  • Page 36: Reflex Testing

    With the OTOflex 100 you can make a range of measurements of a patient’s reflexes. This...

  • Page 37: Acoustic Reflex Threshold

    OTOflex 100 User Manual Ear Pressure is close to atmospheric pressure, do a tympanometric test first. Threshold testing tests the function of the Stapedius muscle. A weak Stapedius muscle cannot sustain tension in the eardrum during pro- longed presentation of a sound, which is loud enough to provoke Reflex.

  • Page 38: Acoustic Reflex Decay

    User Manual OTOflex 100 applied to the ear currently being tested, press the Pressure release button. The pump pressure is relieved immediately. The test as it progresses is shown on the display. When the test is completed, a deflection curve is displayed.
  • Page 39 OTOflex 100 User Manual Reflex. This test measures a reflex , and can be used to record the de- cay caused by a weakening Stapedius muscle. If you have not already done so, do as described in Chapter 3, “Pre- paring for testing”...
  • Page 40 User Manual OTOflex 100 You can make 3 separate tests for each specific test type per patient. If you make more than 3 tests, the first test will be replaced by the new one. Changing this setting is described in Section 5.1.4, ‘Reflex Threshold settings”...

  • Page 41: Eustachian Tube Function - Perforated (Etf-P)

    OTOflex 100 User Manual 4.3.3 Eustachian Tube Function - Perforated (ETF-P) If required, press Select, scroll to A: ETF-P and press Select. The ETF-P screen appears. If required, press the Select Ear key or toggle the Ear icon to select the ear on which you wish to start the test.
  • Page 42 User Manual OTOflex 100 GN Otometrics A/S...

  • Page 43: Setup

    Measurement settings When you are going to do a test, and you have selected the specific test screen in the OTOflex 100, you can change a number of test spe- cific settings. These settings you can either download from the OtoDiagnostics Suite, or you can change them directly in the OTOflex 100.

  • Page 44: Uploading Measurement Settings To The Otodiagnostics Suite

    User Manual OTOflex 100 5.1.2 Uploading measurement settings to the OtoDiagnostics Suite Press Select. Scroll to Upload data, and press Select again. The test spe- cific settings menu is shown. 5.1.3 Tympanometric settings Probe tone Default: 226 Hz If you select 226 Hz, you can set admittance to be shown in mmho or in ml in the field Y unit listed below.
  • Page 45 OTOflex 100 User Manual Stop on data Default: On The measurement stops automatically when data is available for tympanometric peak pressure (TPP) and tympanometric width (TW) and Gradient (TG). Auto classify Default: On This setting relates to the setting in “Normal area” below.

  • Page 46: Reflex Threshold Settings

    User Manual OTOflex 100 Smooth crv [curve] Default: Off Base line Default: On • • If you select a probe tone frequency other than 226 Hz, the base line setting is automatically set to “Off”. 5.1.4 Reflex Threshold settings Man[ual] timing...
  • Page 47 OTOflex 100 User Manual Reflex activator signals (stimuli) Stim[ulus] 0.5 kHz Default: On Stim[ulus] 1 kHz Default: On Stim[ulus] 2 kHz Default: On Stim[ulus] 3 kHz Default: On Stim[ulus] 4 kHz Default: On Stim[ulus] WB Noise Default: Off Stim[ulus] LB Noise...
  • Page 48 User Manual OTOflex 100 Verification Default: None • None • Rpeat Repeats the same level by doing one more stimulus at the same sound level. • DoNxt Does the next stimulus at the next sound level for verification of reflex growth.

  • Page 49: Reflex Decay Settings

    OTOflex 100 User Manual 5.1.5 Reflex Decay settings Probe tone Default: 226 Hz. If you select 226 Hz, you can set admittance to be shown in mmho or in ml in the field Y unit listed below. If you select frequencies other than 226 Hz, admittance is shown only in mmho.

  • Page 50: Device Settings

    Default: Off Curve Smooth Default: 75 Device settings There are a number of settings relating directly to the OTOflex 100. To access these settings: Press Select, scroll to Device Settings, and press Select again. The Device Settings menu is shown. Scroll and press Select to access the menu items.

  • Page 51: Sequence Setup

    5.3.1 Procedure options In the menu item Procedure Opts, you can set the sequence of ac- tions you want the OTOflex 100 to perform, when you switch on the device. Auto start Default: On GN Otometrics A/S...
  • Page 52 User Manual OTOflex 100 Autonew cl[ient] Default: On Auto cl[ient] id Default: On Patient sel[ection] Default: Before Start ear Default: Right Default test Default: Tymp Auto print D Default: Off Auto print E Default: OFF Audible seal Default: On Audible test...

  • Page 53: Viewing Results

    OTOflex 100 User Manual Viewing results Viewing all results Press the Select button to access the Main Menu. Scroll to View all results and press Select. The screen Test Results is shown. The results are sorted according to the individual patients. For...
  • Page 54 User Manual OTOflex 100 GN Otometrics A/S...

  • Page 55: Printing Results

    OTOflex 100 User Manual Printing results Printing a single-page report Press the Select button to access the Main Menu. Scroll to Print report and press Select. The screen Test Results is shown. The results are sorted according to the individual patients. For...
  • Page 56 User Manual OTOflex 100 GN Otometrics A/S...

  • Page 57: Service And Maintenance

    Parts inside the OTOflex 100 must only be checked or serv- iced by authorized personnel. WARNING: Do not disassemble the OTOflex 100 charger, as there is a risk of elec- tric shock. For the sake of safety and in order not to void the warranty, service...

  • Page 58: Maintenance

    8.3.1 Calibration The OTOflex 100 is delivered fully calibrated. The instrument is cal- ibrated in dB SPL or dB HL using the stated reference equivalent thresholds. dB HL are related to sound pressure levels, dB SPL = dB re 20 µPA.
  • Page 59 OTOflex 100 User Manual To remove the probe tip, hold the probe by the probe body and unscrew the threaded ring. Take out the probe tip. Probe body Threaded ring Probe tip Threaded ring Probe tip Check to see if the sound channels of the probe tip are blocked.
  • Page 60 User Manual OTOflex 100 disinfect the brush as well. See Section , ‘Cleaning and disin- fecting procedures for the probe tip” on page Cleaning wire Caution: Even the slightest amount of moisture may dissolve any residual cerumen and thus contaminate the sensitive parts in the body of the probe.

  • Page 61: Cleaning And Disinfecting The Test Cavity

    OTOflex 100 User Manual • Immersion of the probe tip in a Sodium Hypochlorite solution at high concentrations and extended contact time (considered a cold sterilant). When you have cleaned the probe tip, rinse it thoroughly in regular water. Autoclaving...

  • Page 62: Cleaning The Otoflex 100

    • Dismount the probe from the OTOflex 100. Regular cleaning • Clean the OTOflex 100 with a damp cloth - if required, use a surface disinfectant. Note: Never use liquids. Note: Always make sure that no moisture enters the probe or the sockets (charger insert and probe sockets).

  • Page 63: Eartips

    It is therefore recommended that you use only disposable ear tips. The OTOflex 100 eartips and foam eartips for the E-A-RTONE 3A in- sert phone are disposable, and should not be cleaned or re-used. Al- ways throw away disposable eartips after use on a patient.

  • Page 64: Safety Information

    • Do not open, alter or dismantle the charger. 8.3.11 Environmental protection • The OTOflex 100 can be disposed of as normal electronic waste, according to local regulations. • Dispose of batteries according to local regulations. GN Otometrics A/S...

  • Page 65: Troubleshooting

    OTOflex 100 User Manual Troubleshooting The following table supplies solutions to possible issues you may experience with your OTOflex 100: Problem Possible cause Solution OTOflex 100 does not • The batteries are inserted • Insert the batteries correctly. power on even though I incorrectly.
  • Page 66 User Manual OTOflex 100 GN Otometrics A/S...

  • Page 67: Safety

    OTOflex 100 User Manual Safety This User Manual contains information and warnings, which must be followed to ensure the safe performance of the OTOflex 100. Local government rules and regulations, if applicable, should also be fol- lowed at all times. 10.1 Symbols used 10.1.1...

  • Page 68: Charger Unit Symbols

    The term”IC”: before the certification/registration number only signifies that the Industry Canada tech- nical specifications were met. Symbols on buttons to operate Otoflex 100, see Sec- tion 2.6, ‘Display & keypad” on page 10.1.2 Charger unit symbols...

  • Page 69: Warning Notes

    Such noise may interfere with the process of recording cor- rect measurements. Many types of electrical devices, e.g. mobile telephones, may generate radio fields. We recommend that the use of such devices in the vicinity of OTOflex 100 is restricted as much as possible. Note 5: Changes or modifications not expressly approved by the manufac- turer could void the user's authority to operate the equipment.
  • Page 70 (e.g. transducers dropped on the floor). Note that calibra- tion has been performed only on the transducers supplied! If you wish to use any other transducer for testing with the OTOflex 100, please contact your local supplier. Note 12 Choking hazard! Do not leave eartips unsupervised within the reach of children.

  • Page 71: Charger Unit Warning Notes

    OTOflex 100 User Manual 10.2.2 Charger unit warning notes In order to disconnect the charger unit from mains the power cable must be detached from the power source. Note 1: There are no user-serviceable parts inside the charger unit cabinet.
  • Page 72 User Manual OTOflex 100 GN Otometrics A/S...

  • Page 73: Technical Specifications

    OTOflex 100 User Manual Technical Specifications 11.1 Otoflex 100 11.1.1 Compliance measuring system Probe tone: 226Hz @ 85dBspl ± 1.5dB 1000Hz @ 75dBspl ± 1.5dB THD: < 3% in 2 cc Frequency Accuracy: +/-0.5% Range: 0.1 ml to 8.0 ml ± 5% or 0.1 ml whichever is greater 11.1.2...

  • Page 74: Ipsilateral Stimulation

    User Manual OTOflex 100 Probe: Normal range: 50-100 dB HL ± 3 dB Extended range: 500 Hz, 1000 Hz, 2000 Hz, 4000 Hz 50 to 110 dB HL ± 3 dB THD: < 3% in 2 cc 11.1.2.2 Ipsilateral Stimulation...

  • Page 75: Type Identification

    OTOflex 100 User Manual 11.1.5 Type identification Otoflex 100 is type 1012 from GN Otometrics A/S 11.1.6 Power supply Battery types: Rechargeable (Ni-MH type) AA (R6) 1.2V, 4 pcs. (4.8V) Use only rechargeable batteries supplied by GN Otomet- rics A/S Alkaline AA (R6) 1.5V, 4 pcs.

  • Page 76: Dimensions And Weight

    User Manual OTOflex 100 11.2.3 Dimensions and weight Dimensions, without base plate:H: 17.9 mm 7.7 mm 4.8 mm Weight: Charger without base plate: 230 g Charger base plate: 366 g 11.3 Operating mode Mode of operation: Continuous Warm-up time: < 2 min.

  • Page 77: Standards

    User Manual 11.7 Standards Safety: EN 60601-1, UL 2601-1, CAN/CSA -C22.2 NO 601.1-90 Otoflex 100: EN 60601-1, Class II, Internal Powered, Type BF, IPX0 Charger unit: EN 60601-1, Class II, IPX0 EMC: EN 60601-1-2, EN 300 328-2, EN 301 489-17 Impedance/Admittance: EN 61027 Type 1, ANSI S3.39 Type 1...
  • Page 78 User Manual OTOflex 100 GN Otometrics A/S...

  • Page 79: Glossary

    OTOflex 100 User Manual Glossary 12.1 Clinical Terminology Air Conduction (AC) Sound transmitted through air. Acoustic Reflex (AR) Reflexive concentration of the intra-aural muscles in response to loud sound, dominated by the stapedius muscle in humans Acoustic reflex decay Perstimulatory reduction in the magnitude of the acoustic reflex, considered abnormal if it is reduced by over 50% of initial amplitude within 10 seconds of stimulus onset.
  • Page 80 User Manual OTOflex 100 dB HL (hearing level) Decibel scale referenced to accepted standards for normal hearing (0 dB is average normal hearing for each audiometric test frequen- cy). dB nHL (normalized hearing level) Decibel scale used in auditory brain stem response measurement referenced to average behavioral threshold for the click or tone burst stimulus of a small group of normal hearing subjects.
  • Page 81 OTOflex 100 User Manual Intensity Amount of sound energy per unit area. Normative data Statistical information on normal characteristics of data, such as AER latency, amplitude values, or expected threshold intensity level for the response. Immittance audiometry Battery of immittance measurements, including static immittance, tympanometry, and acoustic reflex threshold determination, de- signed to assess middle ear function.
  • Page 82 User Manual OTOflex 100 sive high-frequency electrical activity and may facilitate identifica- tion of major wave components. Sound Level Meter Device for measuring the intensity level of sound waves in air; the unit of measurement is in decibels sound pressure level (SPL dB).

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