natus Madsen Zodiac User manual

Madsen Zodiac
Quick Check
Stand-alone
User Guide
Doc. No.7-50-1600-EN/09
Part No.7-50-16000-EN

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Madsen Zodiac
Copyright notice
© 2016, 2019, 2021, 2022 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.
Version release date
2022-10-25
Technical support
Please contact your supplier.

Madsen Zodiac
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User Guide
Table of Contents
1Overview 4
2Intended use 5
3Unpacking 6
4Installation 7
5Zodiac probes12
6The Quick Check front panel 15
7The Zodiac menu 17
8Testing with Zodiac Quick Check - Stand-alone 18
9Managing test results in Madsen Zodiac 25
10 Printing and data transfer from Zodiac 26
11 Troubleshooting 26
12 Service, cleaning and calibration 27
13 Technical specifications 40
14 Standards and warnings 54
15 Other references 59
16 Manufacturer 59
17 Disposal 60

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Madsen Zodiac
1Overview
Madsen Zodiac Quick Check - Stand-alone
Madsen Zodiac isa compact device for immittance testing.
Operating Madsen Zodiac
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
Hand-held Quick Check probe Gen 1
Hand-held Quick Check probe Gen 2
Supported tests
Dependingon the configuration, Zodiac supports the following tests and functionalities:
•Tympanometry
•Reflex Screening
Madsen Zodiac - Otosuite interfacing
Madsen Zodiac operates with the Otosuite Immittance module. From the Otosuite Immittance module, which is NOAH
compatible, you can perform tests, monitor test results, create User Tests, store and export data, and print reports.
Noah
The Noah System isa HIMSA product for managing clients/patients, launching hearing test applicationsand fitting software,
and storing audiological test results. Madsen Zodiac test results can be stored in the Noah database via Otosuite.
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.

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2Intended use
Madsen Zodiac is an auditory impedance tester intended to change the air pressure in the external auditory canal and
measure and graph the mobility characteristics of the tympanic membrane to evaluate the functional condition of the
middle ear. This device measures the acoustic reflex threshold and decay testing and Eustachian tube function testing for
intact and perforated tympanic membranes.
Users: audiologists, ENTs and other health care professionals in testing the hearing of infants, children and adults.
Use: clinical, diagnostic and screening tympanometry and reflex measurements.
Madsen Zodiac uses technologies that are highly effective for clinical and screening purposes. Tympanometry and acoustic
reflex measurements measure the mechanical response of the middle ear and form a basis for evaluating whether the
related physiological structures are functioning correctly or not.
Clinical Benefit: Madsen Zodiac is used to conduct diagnostic and clinical objective testing used to evaluate the condition
of the middle ear eardrum (tympanic membrane) and the conduction bones by creating variations of air pressure in the
ear canal.
2.1 Contraindications
Caution • If a patient shows discomfort during the test, stop the test. Any measured results are stored.
Caution • Look into the ear canal. Perform an otoscopy to assess the status of the outer ear before you insert the
probe. If the ear canal is blocked, this may affect the result of the test. Clean the ear canal if needed. Make sure
that there is no residual fluid in the patient's ear after cleaning or wax removal.
Caution • Do not perform testing on patients displaying the following symptoms without the approval of a
medical doctor:
•If there is discharge in the ear
•If the patient recently has undergone middle ear surgery
•If the ear canal is occluded
•If the patient suffers from acute trauma
•If the patient experiences severe discomfort
•If the patient displays symptoms of tinnitus or hyperacusis. Do not use excessively loud acoustic stimuli for
acoustic reflex measurements.

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2.2 Tympanometry testing on infants
Use the 1000 Hz probe tone for infant tympanometry up to 4 - 6 months of age to avoid the very low resonance
frequency that is normal for infant ears.
Development through the first few months of life significantly alter the acoustic response properties of the infant's middle
ear, and influence tympanometry, e.g.
•size increase of the external ear, middle ear cavity and mastoid
•a change in the orientation of the tympanic membrane
•fusion of the tympanic ring
•a decrease in the overall mass of the middle ear due to changes in bone density
•loss of mesenchyme (connective tissue of the embryo)
•tightening of the ossicular joints
•closer coupling of the stapes to the annular ligament
•the formation of the bony ear canal wall
The infant ear anatomy differs from the adult ear. Due to these differences, use a higher frequency probe tone to collect
tympanograms to identify middle ear effusion. Infants younger than four (4) months may show abnormal 226 Hz
tympanogram even with confirmed middle ear effusion. It is also possible to obtain what appears to be abnormal 226 Hz
tympanograms in normal ears. The 1000 Hz probe tone is the best choice for immittance measurements in infants.
2.3 Typographical conventions
The use of Warning, Caution and Note
To draw your attention to information regarding safe and appropriate use of the device or software, the manual uses pre-
cautionary statements as follows:
To obtain a free printed copy of the user documentation, contact Natus Medical Denmark ApS (www.natus.com).
3Unpacking
1. Unpack the device carefully.
When you unpack the device and accessories, retain the packing material. If you need to send the device in for service,
the original packing material will protect against damage during transport.
2. Visually inspect the equipment for any damage.
If the device is damaged, do not use it. Contact the Natus representative.
3. Verify package contents. If your package is incomplete, contact the Natus representative.
Warning • Indicates that there is a possibility of injury, death, or other serious adverse reactions associated with
the use or misuse of the device.
Caution • Indicates that there is a possibility of a problem with the device associated with its use or misuse. Such
problems include device malfunction, device failure, damage to the device, or damage to other property.
Note • Indicates that you should take special notice.

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4Installation
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.
See Warning notes ►38.
Location
Perform immittance testing in a quiet room. A sound cabin or sound treated room is not necessary.
Probe
At delivery, the probe is connected to Madsen Zodiac.
Warning • Do not store the device at temperatures below -20°C (-4°F) or above +60°C (95°F).
Do not operate the device at temperatures below +15°C (+59°F) or above +35°C (95°F).
Note • Perform a probe check daily or whenever the test environment changes to verify that the system measures
correctly.
Caution • If the probe check result does not show a value of 1.9 - 2.1 mmho/cc/cm3/ml at 226 Hz, perform an
admittance calibration. See the Zodiac Reference Manual.

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Madsen Zodiac
4.1 Powering the device
Zodiac is powered through an external power supply connected directly to the mains outlet.
Connecting the external power supply to Zodiac
1. Connect the plug end of the external power supply cable to the external power supply socket on the
back of the device.
Connecting the external power supply to the mains supply
1. Connect the mains plug of the external power supply directly to an AC mains outlet with a three-wire
protective ground.
2. If applicable, switch on the mains supply.
The first time you switch on the device
The first time you switch on the device, or if the device has been without power off for more than two weeks, the internal
clock runs out of power. When you start the device, you can set the time manually or connect to Otosuite where the time
is set automatically.
Warning • Use only the power supply specified in Technical specifications ►27.
Note • The first time you power on the device, leave it turned on for at least one hour to let the internal clock battery
charge.

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Switching Madsen Zodiac on and off
1. To switch on Zodiac, press the On/Off button on the lower right side.
– In the stand-alone versions of the device, the display
and some function buttons light up.
2. To switch off Zodiac, press the On/Off button.
If needed, switch off the mains supply and disconnect the
power supply from the mains outlet.
4.2 Connecting to the PC
To connect Zodiac to the PC, you must install Otosuite on the PC.
For Otosuite installation instructions, see the Otosuite Installation Guide, on the Otosuite installation medium.
Connect the USB cable from the USB socket on the back of the device to a USB socket on the PC.
The Otosuite Immittance software module automatically detects the device.
Warning • Use only the USB cable supplied with Zodiac

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Madsen Zodiac
4.3 The built-in printer
The optional built-in printer is located and controlled from the back of the Zodiac device.
1. To open the printer cover, press the printer cover button.
2. To close the printer cover, press the printer cover into place until the lockclicks shut.
Loading a new paper roll
1. Open the printer cover.
2. Remove the empty paper roll.
Caution • Be careful when opening the paper compartment to avoid injury from the cutter blades.
Note • Use only Natus replacement printer paper.

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3. Loosen the paper end edge from the new paper roll.
4. Make sure that the paper compartment is clean.
5. Place the paper roll in the compartment with the loose end opening toward the back of the
compartment and upward from the bottom of the compartment. When you pull the paper upward
before closing the cover, you will see the 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.
8. To close the printer cover, press the printer cover into place until the lock
clicks shut.

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Madsen Zodiac
5Zodiac probes
Health precautions
•Follow established infection control procedures for the setting in which you are working.
•To prevent cross-infection, use new eartips when you test every patient.
Quick Check Probe Gen 2
If applicable, Zodiac arrives with the Quick Check probe Gen 2 already connected.
A. Probe body
B. Ear button
– Press this button to switch test ears
C. Light indicator showing the color of the selected test
ear and leakage status
Using the probe
•Fitting the eartip on the probe ►15
•Cleaning the probe and probe tip ►22
Caution • Inspect the patient's ear. Look into the ear canal. Perform an otoscopy to assess the status of the outer
ear before you insert the probe. If the ear canal is blocked, this may affect the result of the test. Clean the ear canal
if needed. Make sure that there is no residual fluid in the patient's ear after cleaning or ear wax removal.
Caution • An eartip can be used for both ears. If you suspect infection in one ear, use a new eartip and clean
probe tip and probe ring before you continue testing on the other ear.
Caution • Always fit an eartip on the probe before inserting it into the ear of the patient.

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Holding the probe
•Underhand grip
•Overhand grip

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Madsen Zodiac
Quick Check Probe Gen 1
Zodiac is delivered with the Quick Check probe already connected.
A. Probe body
B. Ear button
– Press this button to switch test ears
C. Light indicator showing the color of the selected test
ear and leakage status
Using the probe
•Fitting the eartip on the probe ►15
•Cleaning the probe and probe tip ►22
Holding the probe
•Underhand grip
•Overhand grip
Starting the test
Once you press the screening eartip gently into the ear canal and the seal forms, the test starts automatically.
Stopping the test
You can stop the test by removing the probe from the test ear.
Caution • Always fit an eartip on the probe before inserting it into the ear of the patient.

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6The Quick Check front panel
A. Starting and ending a session
B. Measurement selections
C. Running tests
D. On-screen selections
Dependingon 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.
Report The function of this button dependson the configuration of the system.
•Zodiac with a built-in printer:
Press this button to print all test results for the current patient.
Measurement selections
Tymp
(tympanometry)
Press this button to select the Tympanometry test.
Reflex (Reflex Screening) Press this button to select the Reflex Screening test.

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Madsen Zodiac
Stimulus frequencies (Hz) Press these buttons to select the desired pure tone frequency for the reflex
measurement.
You can choose between the following frequencies:
•0.5 kHz
•1 kHz
•2 kHz
•4 kHz
Noise (stimulus) Press this button to select Broadband noise asa reflex stimulus.
Ear This button is placed 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 individual measurements.
Probe check
Probe check Place the probe in the probe check cavity and press this button to carry out
a probe check.
On-screen selections
Soft button Press this button to select the current function of the soft-button as shown
on the screen just above the soft-button.
•Menu:
Press the soft button below the column.
•Tympanometry:
Press to toggle between tympanometric curves and to change curve
type.
Menu Press this button to display the menu where you can select test setups,
change test settings, create user tests, select print output, and select
functions for service and calibration.
On-screen selections
Arrow Up This function is enabled when you activate the Menu function
•Press this button until you highlight the desired area on the screen.
Arrow Down This function is enabled when you activate the Menu function.
•Press this button until you highlight the desired area on the screen.

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7The 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.
If you need to make further changes to a test setup, or other more specific functions, press Menu or Special for more
choices.
The menu system
Press the Menu button to enter the menu system. You will see
three columns of menu items.
•Left. Shows a list of predefined test protocols.
•Center. Shows the test settings.
•Right. Shows the values.
How to use the menu system
When you press the Menu button, the menu system is shown. The first column is selected: it is shown in gray, and the
selected test protocol is marked up in blue.
•Use the arrow buttons to scroll up or down to select another test protocol, if needed.
•Press the soft button below the next column to select this column and scroll to select any setting to view or
change.
How to change test settings
1. Select a protocol from the left column.
2. Select the center column.
3. Scroll to the setting to view or change.
4. Select the right column to change the setting.
5. Scroll to the value to use and press the Select soft button.
6. Repeat steps 2 to 5 to change other settings, if needed.
Using test settings temporarily
•To change protocol settings temporarily, select the left column, scroll to Apply Temporarily and press the OK soft
button. This will exit the menu system.
Saving test settings in the protocol
Before you can save test settings in the protocol, you must unlock the protocol: Select Device Settings > Protocol
Settings and set to Allowed. If you switch off Zodiac after changing and saving the test settings, the protocol locks again.
•To save the changed protocol settings permanently, select the left column, scroll to Save to [Protocol name], and press
the Save soft button.
Canceling changed test settings
•To cancel any saved settings, select the protocol and press the Reload soft button.

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Madsen Zodiac
8Testing with Zodiac Quick Check - Stand-alone
Madsen Zodiac Quick Check performs automatic 226 Hz
tympanometry which can be combined with Ipsi Reflex testing.
All tests are performed in one single sequence.
Madsen Zodiac is used in combination with the hand-held
Quick Check probe fitted with an eartip.
The measurements are performed automatically when the
probe is pressed gently against the patient's ear canal and
hermetic seal is achieved.
The safety intensity level cannot be exceeded in screening
mode.
8.1 Creating a new session
To test a new patient, create a new session. This will clear the device memory of old data.
When Zodiac is not connected to Otosuite
•When you have finished testing a patient and start testing a new patient, press the New Session
button.
8.2 Using a test setup
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.
Selecting a different test setup during a measurement
You can select a test setup different from the one currently selected.
1. Press the Menu button.
2. Use the arrow buttons to navigate to the desired test setup.
3. Press the Menu button to exit the menu. The selected test setup
will be used for testing.
Caution • The user will see a warning message about high stimulus intensity level if the warning limit is reached.

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8.3 Fitting the eartip on the probes
Gen 2 Probe
Fitting the eartip on the probe
Note that the color and shape of the eartip may vary.
Firmly push and twist the eartip onto the probe tip, until it rests firmly against the base of the probe tip.
Removing the eartip
To remove the eartip, grasp the stem of the eartip and pull the eartip straight off the probe tip.
Fitting the eartip on the probe
Fit the eartip on the probe. Note that the color and shape of the eartip may vary. When removing the eartip,
use your index finger to steady the probe and secure the tube cover housing (see image below).
Note • Use an oversized eartip with the Quick Check probe.

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Gen 1 Probe
Fitting the eartip on the probe
Firmly push and twist the eartip onto the probe tip, until it rests firmly against the base of the probe tip.
Removing the eartip
To remove the eartip, grasp the stem of the eartip and pull the eartip straight off the probe tip.
Note • Use an oversized eartip with the Quick Check probe.