natus Madsen Zodiac User Manual
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natus Madsen Zodiac User Manual

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Madsen Zodiac
Diagnostic & Clinical
Stand-alone
User Guide
Doc. No.7-50-1700-EN/08
Part No.7-50-17000-EN

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Summary of Contents for natus Madsen Zodiac

  • Page 1 Madsen Zodiac Diagnostic & Clinical Stand-alone User Guide Doc. No.7-50-1700-EN/08 Part No.7-50-17000-EN...
  • Page 2 Copyright notice © 2016, 2020, 2021 Natus Medical Denmark ApS. All rights reserved. ® Otometrics, the Otometrics 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.

  • Page 3: Table Of Contents

    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...

  • Page 4: Overview

    Use Zodiac as a stand-alone unit with the built-in keypad and display, or, if you are using the Otosuite Immittance software module, you can use Zodiac with the PC’s keyboard and mouse with the Otosuite Immittance module acting as the display. If you are controlling Zodiac from Otosuite, see the Madsen Zodiac Diagnostic & Clinical PC-based User Guide. Probes Madsen Zodiac supports the following probes: •...

  • Page 5: Intended Use

    Printing test results Some versions of Madsen Zodiac have a built-in thermal printer for printing test results. When testing with Madsen Zodiac in connection with the Otosuite Immittance software module, you can transfer test results to Otosuite for printing as Otosuite reports.
  • Page 6 Note Indicates that you should take special notice. • To obtain a free printed copy of the user documentation, contact Natus Medical Denmark ApS (www.natus.com). Madsen Zodiac...

  • Page 7: Unpacking

    2. Visually inspect the equipment for any damage. If the device is damaged, do not use it. Contact the Natus representative for assistance. 3. Verify the package contents. If the package is incomplete, contact the Natus representative.
  • Page 8 When you start the device, you can set the time manually or connect to Otosuite where the time is set automatically. Switching Madsen Zodiac on and off On/Off 1. To switch on Zodiac, press the button, located on the lower right side.
  • Page 9 Loading a new paper roll Caution • Be careful when opening the paper compartment to avoid injury from the cutter blades. Note Use only Natus replacement printer paper. • 1. Open the printer cover. 2. Remove the empty paper roll.

  • Page 10: The Zodiac Probes

    Health precautions • Follow established infection control procedures for the setting in which you are working. • Always use clean eartips. • To prevent cross-infection, use new eartips when you test every patient. Madsen Zodiac...
  • Page 11 Fitting the eartip on the probe ► • Cleaning the probe and probe tip Caution • Always fit an eartip on the probe before inserting it into the ear of the patient. Holding the probe • Underhand grip • Overhand grip Madsen Zodiac...
  • Page 12 The diagnostic probe and shoulder strap Using the probe ► • Using two probes with the device ► • Fitting the eartip on the probe ► • Fitting the probe in the patient's ear ► • Cleaning the probe and probe tip Madsen Zodiac...
  • Page 13 The diagnostic probe connection The diagnostic probe is permanently connected to the control pad. Connection cable The connection cable connects the diagnostic probe to Zodiac. Connection socket for the contralateral phone When needed, connect the contralateral phone to this socket. Madsen Zodiac...
  • Page 14 Push the plug firmly into the socket until it locks into the socket. Disconnecting the contralateral phone • To disconnect the contralateral phone, hold the reinforced sleeve of the plug and pull firmly until the plug is disconnected. Madsen Zodiac...
  • Page 15 Fit the supra-aural phone on the patient's head so that the center of the phone points toward the opening of the ear canal. Caution • If an ear canal collapses and prevents the stimulus from entering the ear, use the insert phone or follow local recommendations. Madsen Zodiac...

  • Page 16: The Diagnostic And Clinical Front Panel

    Press this button to select the Tympanometry test. (tympanometry) Ipsi (Ipsi) (ipsilateral) Press to select the presentation side for reflex testing (the probe ear). Contra (Contra) (contralateral) Press to select the presentation side for reflex testing (the non-probe ear). Madsen Zodiac...
  • Page 17 You can adjust any settings related to the tests included in the sequence. Diagnostic sequence Set- Tympanometry + Reflex Threshold (+ Reflex Decay, if selected from the tings menu). Screening sequence Tympanometry + Reflex Screening. Madsen Zodiac...
  • Page 18 This function becomes enabled when you activate the Menu function. • Press this button until you highlight the desired area on the screen. Dial In addition to the various measurement functions, use the dial to scroll between menu items on the screen. Madsen Zodiac...

  • Page 19: The Zodiac Menu

    To save the changed protocol settings permanently, select the left column, scroll to (Save to Save [Protocol name]), and press the (Save) soft button. Canceling changed test settings Reload • To cancel any changed settings, select the protocol and press the (Reload) soft button. Madsen Zodiac...

  • Page 20: Special Tests

    Press the (Special) button to exit the special test. Zodiac returns to Tympanometry mode. Exiting the Special Tests menu Cancel Special Tests • Press the (Cancel) soft button to exit the (Special Tests) menu. Zodiac returns to Tympanometry mode. Madsen Zodiac...

  • Page 21: Testing With Zodiac Diagnostic Or Clinical - Stand-Alone

    Perform these measurements manually, automatically or in a sequence of tests with a multiple probe tone option. See the Madsen Zodiac Reference Manual for more features. Zodiac has two probe connections to make it possible to choose between using a Quick Check probe for fast tympanometry, and a diagnostic probe for more detailed measurements.
  • Page 22 The eartip can be used for both ears. If you suspect infection in one ear, use a clean eartip and probe tip before you continue testing on the other ear. Caution • Always use a suitably sized eartip. Using a probe with an unsuitably sized eartip or applying excessive force may cause unnecessary discomfort to the patient. Madsen Zodiac...
  • Page 23 The light indicators Light indicators light up in color in the probe to indicate different states. The control pad on the shoulder strap shows the selected ear color at all times, if you are using the diagnostic probe. Madsen Zodiac...
  • Page 24 • screen. If there is a probe leak during testing, this icon appears 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 25 If the probe is not activated (the probe light is not lighted), activate the probe: • The diagnostic probe: Press the (Ear) button on Zodiac or the Start/Stop (Start/Stop) button on the control pad. • The Quick Check probe: Press the (Ear) button on the probe. Madsen Zodiac...
  • Page 26 Making additional tympanograms Start/Stop 1. To make a new sweep, press the (Start/Stop) button. Previous Curve Next Curve To overwrite a tympanogram, use the dial or the soft-buttons (Previous Curve) or (Next Curve) to select the curve to overwrite. Madsen Zodiac...
  • Page 27 Deflection curves show when a reflex is detected. No Response If a reflex is not detected, the highest stimulus is displayed together with a (No Response) indication. Not Tested If the system cannot automatically analyze a reflex measurement, a (Not Tested) indication is appears. Madsen Zodiac...
  • Page 28 To replace a single measurement, delete a curve and adjust the measurement selections to redo the single measurement. ETF-I (Eustachian Tube Function - Intact) testing This test is available only if Madsen Zodiac supports diagnostic testing. Procedure All three result rows in the Tympanometry results table will be used for this test.
  • Page 29 User Guide Acoustic reflex testing With Madsen Zodiac, automatic testing determines acoustic reflexes automatically using different stimulus levels. Perform a tympanometric test before making any acoustic reflex measurement and determine the acoustic reflex threshold before making a reflex decay measurement.
  • Page 30 (Start/Stop) button on the device or the (Start/Stop) button on the probe control pad on the shoulder strap. The test will stop and the pump pressure is relieved immediately. Already measured results are stored when a test stops. Madsen Zodiac...
  • Page 31 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 Madsen Zodiac...
  • Page 32 (Start/Stop) button to start the test for the preset stimulus. If needed, repeat these steps until you have collected the desired measurements. Caution • If the patient shows discomfort during the test, stop the test. The test will stop immediately. Already measured results are stored. Madsen Zodiac...
  • Page 33 Reflex Decay graph Reflex Decay results table 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 Madsen Zodiac...

  • Page 34: Managing Test Results In Madsen Zodiac

    The results table updates with the selected value. Managing test results in Madsen Zodiac The following directions apply to managing test results in Madsen Zodiac. To perform these actions in Otosuite, see the Otosuite User Guide or Otosuite Reference Manual.

  • Page 35: Printing And Data Transfer From Zodiac

    Hairs in the ear canal get between the eartip and the wall of the ear canal • The probe tip is occluded by debris or fluid • Perform a probe check to rule out malfunction of the probe Madsen Zodiac...

  • Page 36: Service, Cleaning And Calibration

    User Guide Service, cleaning and calibration Warning Do not disassemble Madsen Zodiac. Any service or repair should only be performed by an authorized • service personnel at authorized repair centers. 13.1 Service Service and repair of electro-medical equipment should be performed only by the equipment manufacturer or by service personnel at authorized repair centers.
  • Page 37 Check the channels of the probe tip every time you use the probe. Even small amounts of cerumen or vernix can block the probe channels. Caution • Fit a new probe tip on the probe if you have been testing on an infected ear canal. Cleaning the probe ring may also be necessary. Madsen Zodiac...
  • Page 38 If the probe tip is only slightly blocked, use the probe tip flossing thread to clean the probe tip channels. Note Make sure that you comply with local infection control regulations. • Probe body Probe ring Probe tip Madsen Zodiac...
  • Page 39 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. Caution • Be careful when opening the paper compartment to avoid injury from the cutter blades. Warning When you clean the paper compartment, never use metal objects or liquids.
  • Page 40 ► Check the probe daily See Probe check Additional probe admittance checks can be performed. See the Madsen Zodiac Reference Manual. Annual calibration Note The device and probe(s) must be calibrated once a year by an authorized service department, or after any potential •...

  • Page 41: Technical Specifications

    If the probe is faulty, contact an authorized service department for repair. Technical specifications Type identification Madsen Zodiac is type 1096 from Natus Medical Denmark ApS Compliance measuring system Probe tone: 226 Hz at 85 dB SPL ± 3 dB 678 Hz at 72 dB SPL ±...
  • Page 42 BBN at 50 to 90 dB SPL * ±3 dB (* measured in calibration coupler) Step size dB: 1, 2, 5, 10 dB Decay range: 50 to 100 dB HL* (* artifacts may start to occur at levels above 95 dB HL in 0.5 Madsen Zodiac...
  • Page 43 Stimulus Off time: 64 ms Rise/fall time: 5.5 ms Stimulus presentation control On-Off ratio: 70 dB (for stimulus level > 95 dB HL) A weighted SPL in Off: Contra supra-aural TDH 39: 33 dB Contra insert phone: 23 dB Madsen Zodiac...
  • Page 44 Band limit: 1600 Hz (nominal -3 dB point) Slope: The slope is between +12 and +18 dB/octave below 1600 Hz, with an additional ±6 dB tolerance. Level: Overall noise level is indicated in dB HL. Tolerance ±5 dB. Madsen Zodiac...
  • Page 45 12.5 14.5 Notes: 1. From ANSI/ASA S3.6-2010, Table 5. 2. From ANSI/ASA S3.6-2010, Table 7. 3. Based on Natus internal data. Air pressure system Range: Normal +200 to -400 daPa/s. Extended +400 to -600 daPa/s Pressure sweep rate: 50, 100, 200, 400, 600 daPa/s ± 20% in 20% to 80% of the total pressure range Pressure accuracy: ±...
  • Page 46 Air pressure: 50 kPa to 106 kPa Dimensions (HxWxD) Stand-alone version: 190 mm x 248 mm x 261 mm (7.5” x 9.8” x 10.3”) PC-based version: 100 mm x 240 mm x 240 mm (3.9” x 9.4” x 9.4”) Madsen Zodiac...
  • Page 47 2 cc coupler Calibration 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 Standards section. Standards Safety: IEC 60601-1:2005+AMD1:2012...
  • Page 48 1096 Zodiac Power cord, US (UL approved) with Ferrite Bead 8-71-96100 1096 Zodiac Power Cord, DK with Ferrite Bead Cable 8-62-45900 USB Cable, 3m with 2 Ferrite 8-35-47800 1096 Cavity, 2cc, Integrated (SA only) Cavity 8-35-47900 1096 Cavities, Multi-Frequency Kit Madsen Zodiac...
  • Page 49 IEC 60601-1-2:2014 and EN 60601-1-2:2015 Guidance and manufacturer's declaration - electromagnetic emissions for all equipment and systems Madsen Zodiac is intended for use in the electromagnetic environment specified below. The Madsen Zodiac user should ensure that it is used in such an environment.
  • Page 50 Guidance and manufacturer's declaration - electromagnetic immunity - for equipment and systems within Professional Healthcare use environment Madsen Zodiac is intended for use in the electromagnetic environment specified below. MADSEN Zodiac users should ensure that it is used in this environment.
  • Page 51 IEC 61000-3-3 Guidance and manufacturer's declaration - electromagnetic immunity for all equipment and systems Madsen Zodiac is intended for use in the electromagnetic environment specified below. The Madsen Zodiac user should ensure that it is used in such an environment.
  • Page 52 Guidance and manufacturer's declaration - electromagnetic immunity - for equipment and systems that are NOT life-supporting Madsen Zodiac is intended for use in the electromagnetic environment specified below. The Madsen Zodiac user should ensure that it is used in such an environment.
  • Page 53 TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which MADSEN Zodiac is used exceeds the applicable RF compliance level above, the Madsen Zodiac should be observed to verify normal operation.

  • Page 54: Standards And Warnings

    User Guide Standards and warnings 15.1 Definition of symbols Madsen Zodiac and Otosuite Immittance module Symbol Title Standard as per Symbol Standard Title of Symbol Explanation Reference Referenced Standard Medical An indication of This product is a medical Device Medical Device device.
  • Page 55 Indicates that the medical 1:2016 be used with medical device package device should not be used if Reference no. labels, labeling, and is damaged the package has been 5.2.8. (ISO information to be supplied. damaged or opened. 7000-2606) Madsen Zodiac...
  • Page 56 5.3.1. (ISO shall be handled with care. 7000-0621) ISO 7000 / IEC Graphical symbols for use on Non-ionizing Indicates generally 60417 equipment electromagnetic elevated, potentially radiation hazardous, levels of non- Symbol 5140 ionizing radiation. Madsen Zodiac...
  • Page 57 The following conditions or practices might present possible risk of death or serious injury to the user or patient: • Use Madsen Zodiac equipment only in a hospital or clinic under the guidance of a health care professional. • Any PC connected to Madsen Zodiac must comply with IEC-62368-1.
  • Page 58 Make sure that there are no contraindications for performing the Reflex Decay Test. • Do not use Madsen Zodiac for purposes other than the applications defined in the intended use. • Use new ear tips for each patient to prevent cross-infection.
  • Page 59 • A test stops if a probe leak is detected or the probe is removed from the ear. The probe light shows yellow and the leak status icon appears on the Madsen Zodiac or Otosuite screen. • If the probe tip is blocked, check and clean the probe tip channels.

  • Page 60: Other References

    Madsen Zodiac and the Otosuite modules. For Otosuite installation instructions, see the Otosuite Installation Guide, on the Otosuite installation medium. You can find in-depth information about using Madsen Zodiac in the Madsen Zodiac Reference Manual. The Madsen Zodiac Reference Manual contains troubleshooting examples.

  • Page 61: Disposal Instructions

    WEEE is reused or recycled safely. In line with that commitment Natus Medical Incorporated may pass along the obligation for take back and recycling to the end user, unless other arrangements have been made.
  • Page 62 Madsen Zodiac...

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