1. Manuals
  2. Brands
  3. Madsen Manuals
  4. Test Equipment
  5. zodiac
  6. User manual

Madsen Zodiac User Manual

Diagnostic & clinical stand-alone auditory impedance tester
Hide thumbs Also See for Zodiac:
Table of Contents

Advertisement

Quick Links

See also: Reference Manual
MADSEN Zodiac
Diagnostic & Clinical
Stand-alone
User Guide
Doc. No.7-50-1700-EN/03
Part No.7-50-17000-EN

Advertisement

Table of Contents
loading

Related Manuals for Madsen Zodiac

Summary of Contents for Madsen Zodiac

  • Page 1 MADSEN Zodiac Diagnostic & Clinical Stand-alone User Guide Doc. No.7-50-1700-EN/03 Part No.7-50-17000-EN...
  • Page 2 Copyrightnotice The manufacturer authorizes GN Otometrics A/S to publish manuals approved and released by the manufacturer. © 2016, 2016 GN Otometrics A/S. All rights reserved.® Otometrics, the Otometrics Icon, AURICAL, MADSEN, ICS and HORTMANN are registered trademarks of GN Otometrics A/Sin the U.S.A. and/or other countries. Versionrelease date...

  • Page 3: Table Of Contents

    The Zodiac probes The Diagnostic and Clinical front panel The Zodiac menu Special tests Testing with Zodiac Diagnostic or Clinical - Stand-alone 10 Managing test results in MADSEN Zodiac 11 Printing and data transfer from Zodiac 12 Troubleshooting 13 Service, cleaning and calibration 14 Technical specifications 15 Standards and warnings...

  • Page 4: Overview

    Operating MADSEN Zodiac You can operate Zodiac as a stand-alone unit using the built-in keypad and display, or, if you are using the OTOsuite Immit- tance software module, you can operate Zodiac using the PC’s keyboard and mouse with the OTOsuite Immittance module acting as the display.

  • Page 5: Intended Use

    Printing test results Some versions of MADSEN Zodiac have a built-in thermal printer for printing test results. When MADSEN Zodiac is used in connection with the OTOsuite Immittance software module, test results can be transferred to OTOsuite for printing as OTOsuite reports.

  • Page 6: Unpacking

    3. Check with the packing list to make sure that you have received all necessary parts and accessories. If your package is incomplete, contact your local distributor. Installation To ensure safe performance of the device, make sure that MADSEN Zodiac is correctly installed and that the requirements listed as warning notes are complied with. Warning notes ► 51...
  • Page 7 You can mount the probe home on the wall, using the optional probe home wall-mount kit. Powering Powering the device ► 7 • Powering the device Zodiac is powered through an external power supply connected directly to the mains outlet. Caution Use only the power supply specified in Technical specifications ► 40 •...
  • Page 8 Connecting to the PC To connect Zodiac to the PC, you must install OTOsuite on the PC. For instructions on installing OTOsuite, see the OTOsuite Installation Manual, which you can find on the OTOsuite install- ation medium (disk or memory stick).
  • Page 9 Otometrics watermark. 6. Tear off the part of the paper where glue has held the roll together. 7. Make sure that the loose end of the paper roll emerges through the paper slot. Otometrics - MADSEN Zodiac...

  • Page 10: The Zodiac Probes

    Always use clean eartips. • To prevent cross-infection, use new eartips when you test the next client. The Quick Check probe If applicable, Zodiac is delivered with the Quick Check probe already connected. A. Probe body button – Press this button to switch test ears C.
  • Page 11 You can stop the test by removing the probe from the test ear. The diagnostic probes Depending on the configuration of the device, Zodiac Diagnostic and Zodiac Clinical are delivered with a diagnostic probe already connected. The diagnostic probe is available in two versions.
  • Page 12 A. Shoulder strap B. Hole for hanging shoulder strap C. Diagnostic probe D. Control pad Contralateral phone Probe cable connections Otometrics - MADSEN Zodiac...
  • Page 13 If the probe you wish to use is not activated, press any one of the buttons on the probe to activate it. The contralateral phone If you wish to test for the contralateral reflex, use the contralateral phone to present the stimulus to the non-probe ear. Otometrics - MADSEN Zodiac...
  • Page 14 Insert the eartip in the patient's ear until the outer surface of the eartip is flush with the ear canal entrance. The eartip will expand in the ear canal within a few seconds. Otometrics - MADSEN Zodiac...

  • Page 15: The Diagnostic And Clinical Front Panel

    B. Measurement selections C. Running tests D. On-screen selections Depending on the configuration of the stand-alone version of Zodiac, the front panel has a range of function buttons, a dial, and three soft-buttons. Starting and ending a session New Session Press this button to create a new session.
  • Page 16 Keep the button depressed and use the dial to select the desired pressure. The function of this button is described in-depth in the Reference Manual. Special (special tests) Press this button to select special tests. Otometrics - MADSEN Zodiac...
  • Page 17 This button is located both on the device and on the probes. Press this button to toggle the ear selection associated with the current measurement.The button lights up in the color of the selected ear. Delete Press this button to delete the selected measurement curve. Otometrics - MADSEN Zodiac...

  • Page 18: The Zodiac Menu

    The Zodiac menu If you use a stand-alone version of Zodiac, you can use the function-specific buttons to activate the most commonly used functions for testing, changing test settings, and managing test results.

  • Page 19: Special Tests

    > tings Allowed , and set to . If you switch off Zodiac after changing and saving the test settings, the protocol will be locked again. Save to [Protocol • If you wish to save the changed protocol settings permanently, select the left-hand column, scroll to...

  • Page 20: Testing With Zodiac Diagnostic Or Clinical - Stand-Alone

    2. Scroll to select the special test you wish to use. 3. Press the soft-button. Exiting a special test Special Press the button to exit the special test. Zodiac returns to Tympanometry mode. Exiting the Special Tests menu Cancel Special Tests • Press the soft-button to exit the menu.
  • Page 21 In Zodiac Every time you create a new session in Zodiac, shortcuts to your favorite test setups will be shown on the screen. Use the soft-buttons to select the test setup you prefer. These test setup short-cuts are shown until you start the measurements.
  • Page 22 A measurement will not autostart if the ear canal volume reading is less than 0.1. 7. Any leakage will interrupt the test. The probe will indicate if there is a leak. Otometrics - MADSEN Zodiac...
  • Page 23 Probe leakage If there is a probe leak during testing, this will be shown on the MADSEN Zodiac and OTOsuite screens. If you are using the Quick Check probe, the leakage indication will remain until you remove the probe from the ear and try again.
  • Page 24 User Guide MADSEN Zodiac Zodiac will always perform the most recently selected sequence, either as settings loaded from start-up, as a user test, or as selected on the buttons on the device. Activating sequence mode 1. Press the Seq. button.
  • Page 25 User Guide Start/Stop • The diagnostic probe: Press the button on Zodiac or the button on the control pad. • The Quick Check probe: Press the button on the probe. The probe lights up in the ear color to indicate that it is activated.
  • Page 26 Deflection curves are shown when a reflex has been detected. No Response If a reflex is not detected, the highest stimulus is displayed together with a indication. If the system cannot automatically analyze a reflex measurement, a Not Tested indication is shown. Otometrics - MADSEN Zodiac...
  • Page 27 You can also use Manual Tympanometry for ETF-I. In Manual Tympanometry you can facilitate the equal- • ization maneuvers by keeping the pressure between measurements. Acoustic reflex testing With MADSEN Zodiac, automatic testing determines acoustic reflexes automatically using different stimulus levels. Otometrics - MADSEN Zodiac...
  • Page 28 In the following you will find the description for performing reflex threshold testing as a single test. This means that the sequence function is not enabled. Note • It is recommended that you perform a tympanometric test before making any acoustic reflex measurement, and determine the acoustic reflex threshold before making a reflex decay measurement. Otometrics - MADSEN Zodiac...
  • Page 29 Start/Stop button on the probe control pad on the shoulder strap. The test is interrupted and the pump pressure is relieved imme- diately. Already measured results are kept when a measurement is stopped. Otometrics - MADSEN Zodiac...
  • Page 30 Use the buttons in the Reflex section on the front panel to navigate between the measurements. Your selection is high- lighted in the Reflex results table. The results table shows the results related to the currently selected curve: • Stimulus side • Stimulus frequency • Threshold levels Otometrics - MADSEN Zodiac...
  • Page 31 8. If needed, repeat these steps until you have collected the desired meas- urements. Warning If the patient is troubled by the test, stop the test. The test is • interrupted immediately. Already measured results are kept. Otometrics - MADSEN Zodiac...
  • Page 32 C. Reflex Decay results table D. On-screen selections On-line values The on-line values show the current settings and status. • Probe tone in Hz • Stimulus side • Stimulus frequency • Stimulus level • Current pressure and admittance scales Otometrics - MADSEN Zodiac...

  • Page 33: Managing Test Results In Madsen Zodiac

    The results table is updated with the selected value. Managing test results in MADSEN Zodiac The following applies to managing test results in MADSEN Zodiac. If you wish to perform these actions in OTOsuite, see the OTOsuite User Guide or OTOsuite Reference Manual.

  • Page 34: Printing And Data Transfer From Zodiac

    2. Press the Delete button. Printing and data transfer from Zodiac Report You can print out test results directly from Zodiac, if it is equipped with a built-in printer. Printing from the built-in printer Report • If the device is configured to print directly from the built-in printer, press the button to print out the test res- ults.

  • Page 35: Service, Cleaning And Calibration

    • Recommended cleaning agents ► 36 Frequency We recommend that you set up a schedule for cleaning Zodiac and accessories such as probes and/or earphones. Prerequisites • Before cleaning, switch off MADSEN Zodiac and disconnect it from any external power source.
  • Page 36 Although the probes are designed to be easily cleaned, care should be taken to make sure that they last a long time. Note Check the sound channels in the probe tip every time you have used the probe.Even small amounts of cerumen • or vernix can block the sound channels. Clean the sound channels if needed. Otometrics - MADSEN Zodiac...
  • Page 37 User Guide Note Accurate testing is only guaranteed if you use the eartips approved specifically for MADSEN Zodiac by Oto- • metrics. Ear canal debris blocking the probe tubes can lead to abnormally large ear canal volume readings, leak messages, and other odd results.
  • Page 38 Check the paper compartment regularly to make sure that it is free from paper dust and that the thermal paper head is clean. Prerequisites • Before cleaning, switch off MADSEN Zodiac and disconnect it from any external power source. Otometrics - MADSEN Zodiac...

  • Page 39: Probe Check

    Probe check The probe should be checked daily. Probe check ► 39 Additional probe admittance checks can be performed. See the MADSEN Zodiac Reference Manual. Note • If the test environment changes, for instance if there is an increase in humidity or if you are going to test at a different altitude, make a probe check to verify that the system measures correctly.

  • Page 40: Technical Specifications

    1.9 - 2.1 mmho/cc/ml at 226 Hz, the probe is OK. If not, we recom- mend that you make an admittance calibration. Additional probe admittance checks can be performed. See the MADSEN Zodiac Reference Manual.  If there is a probe error In case of a probe error, the probe may be occluded or faulty.
  • Page 41 < 2.5 % for levels below 110 dB HL < 10% for levels above 110 dB HL < 5 % for levels above 110 dB HL Ipsilateral Stimulation Tone: 500 Hz, 1000 Hz, 2000 Hz, 4000 Hz Frequency accuracy: ± 0.5% Otometrics - MADSEN Zodiac...
  • Page 42 1. Tolerance +120/-0 ms Characteristics for pulsed stimuli (ipsilateral) Pulsed stimuli are used for ipsilateral Reflex Screening and Reflex Threshold testing. Period: 120 ms Stimulus On time: 56 ms Stimulus Off time: 64 ms Rise/fall time: 5.5 ms Otometrics - MADSEN Zodiac...
  • Page 43 1600 Hz (nominal -3 dB point) Slope: The slope is between +12 and +18 dB/octave below 1600 Hz, with an addi- tional ±6 dB tolerance. Level: Overall noise level is indicated in dB HL. Tolerance ±5 dB. Otometrics - MADSEN Zodiac...
  • Page 44 Pump measure direction: Positive to negative or negative to positive Safety: Separate safety +530 daPa and -730 daPa ±70 daPa Graph units Unit of admittance graph Y-axis: ml, cc, mmho, µl Unit of graph X-axis: daPa, sec Otometrics - MADSEN Zodiac...
  • Page 45 The admittance of a cavity depends on the atmospheric pressure. This means that when the atmospheric pressure changes, the relation between mmho and ml changes. The following table can be used to calculate the difference. Altitude (m) Increase in mmho (%) 1000 1500 2000 2500 3000 Otometrics - MADSEN Zodiac...
  • Page 46 Equipment should be calibrated regularly according to EN 60645-5 and ANSI S3.39 Essential performance MADSEN Zodiac has no essential performance and accordingly, the applicable requirements are as stated in the following: 1. Impedance/admittance as defined by EN 61027 Type 1, ANSI S3.39 Type 1.
  • Page 47 Notes on EMC (Electromagnetic Compatibility) • MADSEN Zodiac is part of a medical electrical system and is thus subject to special safety precautions. For this reason, the installation and operating instructions provided in this document should be followed closely. •...
  • Page 48 User Guide MADSEN Zodiac isintended for use in the electromagnetic environment specified below. The user of MADSEN Zodiac should ensure that it isused in such an environment. Emissionstest Compliance Electromagnetic environment - guidance RF emissions Group 1 MADSEN Zodiac uses RF energy only for its internal function. Therefore, its RF emissions are very CISPR 11 low and are not likely to cause any interference in nearby electronic equipment.
  • Page 49 Recommended separation distances between portable and mobile RF communications equipment and MADSEN Zodiac The MADSEN Zodiac is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the MADSEN Zodiac can help prevent electromagnetic interference by maintaining aminimum distance between portable and mobile RF communications equip- ment (transmitters) and the MADSEN Zodiacas recommended below, according to the maximum output power of the communications equipment.

  • Page 50: Standards And Warnings

    Consult user manual for warnings and cautions. Consult user manual for warnings and cautions. Complies with Type BF requirements of IEC60601-1. Complies with Medical Devices Directive 93/42/EEC and RoHS Directive (2011/65/EC). Complies with the Radio Equipment and Telecommunications Terminal Equipment Directive 1999/5/EC. Otometrics - MADSEN Zodiac...
  • Page 51 1. This class of equipment is allowed in domestic establishments when used under the jurisdiction of a health care pro- fessional. 2. MADSEN Zodiac is intended for diagnostic and clinical use by audiologists and other trained health care professionals in testing the hearing of their patients.
  • Page 52 Proof that connected equipment has been tested in accordance with IEC 60601-1 (3rd), AAMI ES60601-1 and CAN/CSA-C22.2 NO. 60601-1-08-CAN/CSA. Do not touch the output DC plug of the power supply or connectors of the device or connected devices and the patient at the same time. Otometrics - MADSEN Zodiac...

  • Page 53: Other References

    Consult the dealer or an experienced radio/TV technician for help. Other references For more information, see the online Help in OTOsuite, which contains detailed reference information about MADSEN Zodiac and the OTOsuite modules. For instructions on installing OTOsuite, see the OTOsuite Installation Manual, which you can find on the OTOsuite install- ation medium (disk or memory stick).
  • Page 54 User Guide The manufacturer reserves the right to disclaim all responsibility for the operating safety, reliability and performance of equipment serviced or repaired by other parties. Otometrics - MADSEN Zodiac...

Table of Contents