otometrics Madsen Zodiac User manual

MADSEN Zodiac
Quick Check
Stand-alone
User Guide
Doc. No.7-50-1600-EN/05
Part No.7-50-16000-EN

Copyright notice
The manufacturer authorizes GN OtometricsA/S to publish manuals approved and released by the manufacturer.
© 2016,2018GN OtometricsA/S. All rights reserved. ® Otometrics, the OtometricsIcon, AURICAL, MADSEN, Otoscan, ICS and
HORTMANN are registered trademarks of GN OtometricsA/S in the U.S.A. and/or other countries.
Version release date
2018-12-06 (204106)
Technical support
Please contact your supplier.
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Table of Contents
1 Overview 4
2 Intended use 5
3 Unpacking 6
4 Installation 6
5 The Quick Check probe 9
6 The Quick Check front panel 11
7 The Zodiac menu 13
8 Testing with ZodiacQuick Check - Stand-alone 14
9 Managing test results in MADSEN Zodiac 19
10 Printing and data transfer from Zodiac 20
11 Troubleshooting 20
12 Service, cleaning and calibration 20
13 Technical specifications 26
14 Standards and warnings 37
15 Other references 40
16 Manufacturer 40
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1 Overview
MADSEN Zodiac is a compact device for immittance testing.
MADSEN ZodiacQuick Check - Stand-alone
See Testing with ZodiacQuick Check - Stand-alone ►
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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.
Note •If you are controlling Zodiacfrom OTOsuite, see theMADSEN ZodiacDiagnostic & ClinicalPC-basedUser
Guide.
Probes
• The hand-held Quick Check probe
Supported tests
Depending on the configuration, Zodiac supports the following tests and functionalities:
• Tympanometry
• Reflex Screening
MADSEN Zodiac - OTOsuite interfacing
MADSEN Zodiac is designed to operate 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 is a HIMSA product for managing clients/patients, launching hearing test applications and 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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2 Intended use
MADSEN Zodiac is an auditory impedance tester that is 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 is also used to measure the acoustic reflex threshold and decay testing as well as 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 which are highly effective for clinical and screening purposes. Tympanometry and acous-
tic 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.
Contraindications
Warning •If the patient is troubled by the test, stop the test. The test is interrupted immediately. Already measured
results are kept.
Warning •Look into the ear canal. It is strongly recommended that you 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.
Warning •Testing should not be performed 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, in which case using excessively loud acoustic stimuli
for acoustic reflex measurements should be avoided.
2.1 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:
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Warning •Indicates that there is a risk of death or serious injury to the user or patient.
Caution •Indicates that there is a risk of injury to the user or patient or risk of damage to data or the device.
Note •Indicates that you should take special notice.
To obtain a free printed copy of the user documentation, contact Otometrics (www.otometrics.com).
3 Unpacking
1. Unpack the device carefully.
When you unpack the device and accessories, it is a good idea to keep the packing material in which they were
delivered. If you need to send the device in for service, the original packing material will protect against damage dur-
ing transport, etc.
2. Visually inspect the equipment for possible damage.
If damage has occurred, do not put the device into operation. Contact your local distributor for assistance.
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.
4 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.
See Warning notes ►38.
Location
Caution •Operation at temperatures exceeding -20°C (-4°F) or +60°C (140°F) may cause permanent damage to the
device.
Immittance testing is facilitated by a moderately quiet room. A sound cabin or sound treated room is not necessary.
Probe
At delivery, the probe is already connected to MADSEN Zodiac.
We recommend that you carry out a probe check daily to verify that the system measures correctly.
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Note •If the probe check result does not show a value of 1.9 - 2.1 mmho/cc/cm3/ml at 226 Hz, we recommend that
you make an admittance calibration. See the Zodiac Reference Manual.
Probe home
You can mount the probe home on the wall, using the optional probe home wall-mount kit.
Powering
• See Powering the device ►7.
4.1 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 ►26.
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
Note •The first time you switch on the device, leave it turned on for at least an hour to let the internal clock battery
charge.
The first time you switch on the device, or if the device has been switched off for more than two weeks, the internal clock
runs out of power. When you start up the device, you will be prompted to set the time manually.
• Set the date and time as required on the device.
• Alternatively, you can connect to OTOsuite where it will be done automatically.
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Switching MADSEN Zodiac on and off
1. To switch on Zodiac, press the On/Off button.
– 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.
Caution •Use only the USB cable supplied with Zodiac.
Connect the USB cable from the USB socket on the back of the device to a USB socket on the PC. The OTO-
suite Immittance software module automatically detects the device.
4.3 The built-in printer
The built-in printer, which is optional, is placed on the back of Zodiac.
The printer is controlled from the front panel of the 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 lock
clicks shut.
Loading a new paper roll
Warning •When you open the paper compartment, be careful not to injure your hands on the cutter blades.
Caution •Use only the paper type listed in the Accessories list. Other qualities of paper may damage the printer.
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1. Open the printer cover.
2. Remove the spool of the used paper roll.
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 towards
the back of the compartment and upwards from the bottom of the com-
partment. When you pull the paper upwards 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.
5 The Quick Check probe
Zodiac is delivered with the Quick Check probe already connected.
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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
Warning •Always fit an eartip on the probe before inserting it into the ear of the patient.
Warning •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.
Holding the probe
• Underhand grip
• Overhand grip
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Starting the test
The test starts automatically when you press the screening eartip gently into the ear canal and seal is obtained.
Stopping the test
You can stop the test by removing the probe from the test ear.
6 The Quick Check front panel
A. Starting and ending a session
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.
Report The function of this button depends on 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.
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Reflex (Reflex Screening) Press this button to select the Reflex Screening test.
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 as a 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.
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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 you wish to go to.
• 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 func-
tions for service and calibration.
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.
7 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.
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.
• The left-hand column shows a list of predefined test protocols.
• The center column shows the test settings.
• The right-hand column 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.
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• Press the soft-button below the next column to select this column, and scroll to any setting you wish to view or
change.
How to change test settings
1. Start by selecting a protocol.
2. Select the center column.
3. Scroll to the setting you wish to view or change.
4. Select the right-hand column to change the setting.
5. Scroll to the value you wish to use and press the Select soft-button.
6. Repeat steps 2 to 5 to change other settings, if needed.
Using test settings temporarily
• If you only wish to use the changed protocol settings temporarily, select the left-hand column, scroll to Apply Tem-
porarily 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 Set-
tings, and set to Allowed. If you switch off Zodiac after changing and saving the test settings, the protocol will be locked
again.
• If you wish to save the changed protocol settings permanently, select the left-hand column, scroll to Save to [Protocol
name], and press the Save soft-button.
Canceling changed test settings
• If you wish to cancel the settings you have changed, select the protocol and press the Reload soft-button.
8 Testing with ZodiacQuick Check - Stand-alone
Note •The safety intensity level cannot be exceeded in screening mode.
MADSEN ZodiacQuick Check performs automatic 226 Hz tym-
panometry 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 her-
metic seal is achieved.
8.1 Creating a new session
When you wish to test a new patient, create a new session. This will clear the device memory of old data.
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When Zodiac is not connected to OTOsuite
• When you have finished testing a patient and wish to 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.
8.3 Fitting the eartip on the probe
The Quick Check probe
• We recommend that you use an oversized eartip with the Quick Check probe.
Fitting the eartip on the probe
1. 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.
8.4 Starting a measurement
1. Look into the ear canal. It is strongly recommended that you perform an otoscopy to assess the status of the outer ear
before you insert the probe.
2. If the ear canal is blocked, this may affect the result of the test. Clean the ear canal if needed.
Caution •The probe can be damaged if fluids enter the probe.
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Warning •Always fit the probe with a new eartip when you place the probe in the ear canal of a new patient.
Warning •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 •Avoid excessive force when you place the ear tip against the ear canal opening of the patient as this may
cause unnecessary discomfort, particularly if the eartip is small enough to enter the ear canal.
Fit the probe in the ear
1. With a hand-held probe you can use a slightly over-
sized eartip in order to achieve a seal when used
with a wider range of ear canal sizes.
The oversized eartip is not intended to enter the
ear canal.
2. Fit the eartip on the probe.
3. Ask the patient to sit very still and quiet during
the test, without moving head or jaw.
4. Press the probe against the patient's ear canal so
that a hermetic seal is achieved. The meas-
urement starts automatically.
5. To stabilize the probe and to avoid blocking the
probe against the ear canal of the patient, grasp
the pinna and gently pull the pinna back and
slightly away from the patient's head.
– For adults: pull the pinna upwards and back.
– For infants and children: pull the pinna down-
wards and back.
Quick Check probe placement
6. A flat tympanogram together with an abnormally
small ear canal volume (ECV) indicates that the
probe is blocked
7. Any leakage will interrupt the test. The probe will
indicate if there is a leak.
When you get a leak detection signal, you must
briefly remove the probe from the ear before try-
ing again.
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Probe status and leakage
The light indicators
Light indicators light up in color in the probe to indicate different states.
Probe color Status
Red • The right test ear has been selected
• The device is in idle mode
Blue • The left test ear has been selected
• The device is in idle mode
Green • The test is running
Yellow • Leak
OTOsuite indications
Color Status
Green • During measurements, OTOsuite shows a green background to the online
values.
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.
Probe blocked
If the probe is blocked during testing, this will be shown on the MADSEN Zodiac and OTOsuite screens.
If you are using the Quick Check probe, the blocked probe indication will remain until you remove the
probe from the ear and try again.
8.5 The Quick Check measurement screen
When the measurement starts, you will see the measurement being performed real-time on the screen.
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A. On-line values
B. Tympanometry graph
C. Reflex Screening results
D. Tympanometry results
E. On-screen selections
A. On-line values
The on-line values show the current settings and status.
• Probe tone in Hz
• Pump speed
• Sweep direction
• Current equivalent volume/admittance (678, 800, 1000 Hz probe tone)
B. Tympanometry graph
The graph area shows the tympanometric curves and can rescale automatically to fit the curves.
• Tympanometric curves
• Pressure and admittance scales
• Ear canal volume bar. The ear canal volume is shown to the right of the graph.
•Norm area
C. Reflex Screening results
The detected reflex is shown in the results area.
• Stimulus type level
• Progress indicator during measurements
• Deflection curves are shown when a reflex has been detected.
If a reflex is not detected, the highest stimulus is displayed together with a No Response indication.
If the system cannot automatically analyze a reflex measurement, a Not Tested indication is shown.
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D. Tympanometry results
The results table shows the results related to the currently selected curve:
•Probe (the probe tone in Hz)
•TPP (Tympanometric Peak Pressure)
•ECV (Equivalent Ear Canal Volume)
•SA (Static Peak Admittance), or SC (Static Peak Compliance) when volume equivalent units are used
•TW/Ratio (Tympanometric Width/Tympanometric Ratio). Describes the steepness of the curve.
•Type (Jerger types A, As, Ad, B, C, D and E denote the shape of the 226 Hz curve). You can set the type to be
determined automatically, and you can subsequently change it manually, if necessary.
E. On-screen selections
Curve selection Press the Previous Curve or Next Curve softbutton to select the desired curve in
the Reflex Screening and Tympanometry result tables.
Manually adjusting the TPP Press the Edit TPP softbutton, use the dial to move the marker to the desired
TPP, and press the Done softbutton.
Changing tympanogram curve type Press the Edit TPP softbutton. Press the Change Type softbutton until the
desired type is shown, and press the Done softbutton.
Deleting a curve Select the curve you wish to delete, and press the Delete button.
To replace a single measurement, delete a curve and adjust the measurement
selections to redo the single measurement.
9 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.
Swapping ear results
If you have tested a patient with the wrong ear selected, you can swap the ear results both during a session and after a ses-
sion so that the results are assigned to the other ear. Swapping applies to all tests made on that patient.
Deleting measurements
1. You can delete a single measurement curve by using the soft-button functions Previous Curve or Next Curve to select
the curve you wish to delete.
2. Press the Delete button.
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10 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
• If the device is configured to print directly from the built-in printer, press the Report button to print out the test res-
ults.
Remember to write the patient's name on the print-out.
Transferring data to OTOsuite
If you need to change the patient in OTOsuite, while you are working with OTOsuite you can fetch the patient's test
results from Zodiac.
11 Troubleshooting
11.1 Probe problems - possible causes
Testing may be complicated by a number of factors which can result in leakage or probe problems.
• The eartip does not fit well
• The eartip is not inserted properly in the ear canal
• The probe tip opening is blocked by the wall of the ear canal
• The eartip may be old or hardened
• The probe tip has not been attached properly to the probe body
• 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.
12 Service, cleaning and calibration
Warning •Under no circumstances disassemble MADSEN Zodiac. Contact your supplier. Parts inside MADSEN Zodiac
must only be checked or serviced by authorized personnel.
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