natus Madsen Zodiac User manual

Madsen Zodiac
Reference Manual
Doc. No.7-50-1610-EN/08A
Part No.7-50-16100-EN

2
Madsen Zodiac
Copyright notice
© 2016, 2020, 2021 Natus Medical Denmark ApS. All rights reserved. ® Otometrics, the Otometrics Icon, Aurical, Madsen, HI-PRO 2,
Oto- scan, ICS and HORTMANN are registered trademarks of Natus Medical Denmark ApS in the U.S.A. and/or other countries.
Version release date
2021-11-30
Technical support
Please contact your supplier.

3
Madsen Zodiac
Table of Contents
Table of Contents ..............................................................................................................................................................3
1Introduction to Madsen Zodiac ...................................................................................................................................6
1.1 The Otosuite Immittance module............................................................................................................................... 7
1.2 Intended use.............................................................................................................................................................. 8
1.2.1 Contraindications ............................................................................................................................................ 8
1.3 About this manual ..................................................................................................................................................... 9
1.4 Typographical conventions........................................................................................................................................ 9
1.5 Navigating this manual............................................................................................................................................. 10
2Unpacking and installation........................................................................................................................................10
2.1 Unpacking ............................................................................................................................................................... 10
2.2 Storing..................................................................................................................................................................... 10
2.3 Installing Zodiac....................................................................................................................................................... 10
2.3.1 Powering the device ...................................................................................................................................... 11
2.3.2 Switching the Madsen Zodiac on and off ...................................................................................................... 11
2.3.3 Connecting to the PC..................................................................................................................................... 12
2.3.4 Reconnecting to the device............................................................................................................................ 12
2.3.5 Configuring the device .................................................................................................................................. 12
2.4 Communication between Otosuite and Zodiac ........................................................................................................ 13
2.4.1 Configuring the Immittance module ............................................................................................................. 13
2.4.2 Test device information ................................................................................................................................. 14
3The built-in printer....................................................................................................................................................15
4Views of Zodiac .........................................................................................................................................................17
4.1 Front view ............................................................................................................................................................... 17
4.2 Bottom view............................................................................................................................................................. 18
5The Zodiac probes.....................................................................................................................................................19
5.1 The Quick Check probe ........................................................................................................................................... 19
5.2 The diagnostic probes.............................................................................................................................................. 21
5.2.1 The diagnostic probe and shoulder strap ...................................................................................................... 21
5.2.2 Using two probes with the device ................................................................................................................. 23
5.2.3 The contralateral phone ................................................................................................................................ 23
6Madsen Zodiac test controls......................................................................................................................................25
6.1 The Quick Check front panel.................................................................................................................................... 25
6.2 The Diagnostic and Clinical front panel.................................................................................................................... 27
6.3 The Zodiac menu ..................................................................................................................................................... 30
6.4 Special tests............................................................................................................................................................. 31
7Preparing for testing..................................................................................................................................................32
7.1 Preparing the test environment............................................................................................................................... 32
7.2 Health precautions .................................................................................................................................................. 32
7.3 Probe check............................................................................................................................................................. 32
7.4 Creating a new session ............................................................................................................................................ 33
7.5 Using a test setup ..................................................................................................................................................... 33
7.6 Inspecting the patient’s ear....................................................................................................................................... 34
7.7 Fitting the eartip on the probe ................................................................................................................................ 34
7.8 Fitting the probe in the patient’s ear ....................................................................................................................... 35
8Testing with Zodiac Quick Check - Stand-Alone..........................................................................................................38
8.1 Starting a measurement .......................................................................................................................................... 38
8.2 The Quick Check measurement screen .................................................................................................................... 40

4
Madsen Zodiac
9Testing with Zodiac Diagnostic or Clinical -Stand-Alone .............................................................................................43
9.1 Quick Check testing ................................................................................................................................................. 43
9.1.1 Starting a measurement ................................................................................................................................ 43
9.1.2 The Quick Check measurement screen........................................................................................................... 46
9.2 Sequence testing ...................................................................................................................................................... 48
9.2.1 Selecting a test sequence .............................................................................................................................. 48
9.2.2 Running a test sequence................................................................................................................................ 48
9.3 Tympanometry testing............................................................................................................................................. 49
9.3.1 The Tympanometry screen............................................................................................................................. 51
9.4 ETF-I (Eustachian Tube Function - Intact) testing ..................................................................................................... 53
9.5 Acoustic reflex testing.............................................................................................................................................. 54
9.6 Reflex Threshold testing .......................................................................................................................................... 54
9.6.1 The Reflex Threshold screen .......................................................................................................................... 56
9.7 Reflex Decay testing................................................................................................................................................. 58
9.7.1 The Reflex Decay screen................................................................................................................................. 60
9.8 Manual Tympanometry ............................................................................................................................................ 61
9.8.1 The Manual Tympanometry screen................................................................................................................ 62
9.9 Admittance (Y) Recorder.......................................................................................................................................... 63
9.9.1 The Admittance (Y) Recorder screen.............................................................................................................. 65
9.10 ETF-P 66
9.10.1 The ETF-P screen ............................................................................................................................................ 67
10 The Otosuite Immittance module .............................................................................................................................69
10.1 Otosuite toolbar icons and control panels ............................................................................................................... 69
10.2 Shortcut keys ........................................................................................................................................................... 74
10.3 Leakage and other probe problems ......................................................................................................................... 76
11 Testing with Zodiac Quick Check - PC-based...............................................................................................................78
11.1 Starting a measurement .......................................................................................................................................... 78
11.2 The Quick Check measurement screen .................................................................................................................... 80
12 Testing with Zodiac Diagnostic or Clinical - PC-based..................................................................................................82
12.1 Sequence testing...................................................................................................................................................... 82
12.1.1 Setting up a sequence ................................................................................................................................... 82
12.1.2 Running a test sequence................................................................................................................................ 83
12.2 Quick Check testing ................................................................................................................................................. 83
12.3 Tympanometry testing.............................................................................................................................................. 84
12.3.1 The Tympanometry screen............................................................................................................................. 86
12.4 ETF-I (Eustachian Tube Function - Intact) testing...................................................................................................... 87
12.6 Reflex Threshold testing .......................................................................................................................................... 89
12.6.1 Manual Reflex Threshold testing................................................................................................................... 89
12.6.2 Automated Reflex Threshold testing.............................................................................................................. 91
12.6.3 The Reflex Threshold screen .......................................................................................................................... 92
12.7 Reflex Decay testing................................................................................................................................................. 94
12.7.1 The Reflex Decay screen ................................................................................................................................ 95
12.8 Manual Tympanometry ............................................................................................................................................ 97
12.8.1 The Manual Tympanometry screen................................................................................................................ 98
12.9 Admittance (Y) Recorder.......................................................................................................................................... 99
12.9.1 The Admittance (Y) Recorder screen ............................................................................................................ 100
12.10 ETF-P 102
12.10.1 The ETF-P screen..................................................................................................................................... 103
12.11 Tympanogram History............................................................................................................................................ 104
12.11.1 The Tymp History screen....................................................................................................................... 105
13 Managing test results in Madsen Zodiac ..................................................................................................................107
14 Printing from Zodiac ................................................................................................................................................108
15 Transferring data to Otosuite..................................................................................................................................109

5
Madsen Zodiac
16 Printing test results from Otosuite ...........................................................................................................................110
17 Service and maintenance........................................................................................................................................111
17.1 Equipment failure .................................................................................................................................................. 111
17.2 Service and repair.................................................................................................................................................. 111
17.3 Maintenance ......................................................................................................................................................... 112
17.3.1 Calibration................................................................................................................................................... 112
17.3.2 Probe admittance calibration ...................................................................................................................... 112
17.4 Cleaning Madsen Zodiac ........................................................................................................................................ 114
17.4.1 Recommended cleaning agents.................................................................................................................... 115
17.4.2 Cleaning the shoulder strap......................................................................................................................... 115
17.4.3 Cleaning the probe and probe tip................................................................................................................ 115
17.4.4 Fitting a new probe tip................................................................................................................................ 117
17.4.5 Cleaning the test cavities............................................................................................................................. 118
17.4.6 Cleaning the printer..................................................................................................................................... 118
17.4.7 Disposable accessories................................................................................................................................. 119
18 Standards and warnings .........................................................................................................................................120
18.1 Definition of symbols ............................................................................................................................................ 120
18.2 Warning notes ....................................................................................................................................................... 123
18.3 Caution notes ........................................................................................................................................................ 124
18.4 Notes .................................................................................................................................................................... 125
18.5 Other references ................................................................................................................................................... 126
18.6 Manufacturer ........................................................................................................................................................ 126
18.7 Responsibility of the manufacturer........................................................................................................................ 126
19 Disposal instructions ...............................................................................................................................................126
20 Technical specifications...........................................................................................................................................127
21 Accessories .............................................................................................................................................................134
22 Notes on EMC (Electromagnetic Compatibility)........................................................................................................135
App. 1 Madsen Zodiac immittance methodology andfeatures..................................................................................140
App. 1.1 An introduction to immittance .................................................................................................................... 140
App. 1.1.1 Immittance testing ........................................................................................................................... 140
App. 1.2 Tympanometry............................................................................................................................................ 141
App. 1.2.1 Tympanometry testing on infants .................................................................................................... 141
App. 1.2.2 Tympanometric features................................................................................................................... 141
App. 1.2.3 ETF-I (Eustachian Tube Function - Intact).......................................................................................... 143
App. 1.2.4 Valsalva’s Maneuver......................................................................................................................... 143
App. 1.2.5 Toynbee’s Maneuver ........................................................................................................................ 143
App. 1.3 Acoustic Reflex testing................................................................................................................................. 144
App. 1.3.1 Acoustic reflex quick check............................................................................................................... 144
App. 1.3.2 Acoustic reflex threshold.................................................................................................................. 145
App. 1.3.3 Acoustic reflex decay........................................................................................................................ 145
App. 1.3.4 Admittance Recording ...................................................................................................................... 145
App. 1.4 ETF-P (Eustachian Tube Function - Perforated)............................................................................................ 145
App. 1.5 Susceptance and Conductance, B/G............................................................................................................. 146
App. 1.5.1 Susceptance, B ................................................................................................................................. 146
App. 1.5.2 Conductance, G ................................................................................................................................ 147
App. 1.5.3 B/G viewing of tympanograms ......................................................................................................... 147
App. 1.5.4 Component compensation ............................................................................................................... 148

6
Madsen Zodiac
1Introduction to Madsen Zodiac
Madsen Zodiac is a compact device for immittance testing.
Madsen Zodiac is available both as a Quick Check device and as a diagnostic testing device. Both types can be operated
either directly from the device (Stand-alone), and/or from the Otosuite Immittance module software (PC-based).
Madsen Zodiac Quick Check - Stand-Alone Madsen Zodiac Diagnostic and Clinical - Stand-Alone
See Testing with Zodiac Quick Check -
Stand-Alone 38
See Testing with Zodiac Diagnostic or Clinical -Stand-
Alone 43
Madsen Zodiac Quick Check - PC-based Madsen Zodiac Diagnostic and Clinical - PC-based
See Testing with Zodiac Quick Check - PC-based 78 See Testing with Zodiac Diagnostic or Clinical - PC-based 82
Supported tests
Depending on the configuration, Zodiac supports the following tests and functionalities:
•Tympanometry (Quick Check, Diagnostic, Clinical)
•Reflex Screening (Quick Check, Diagnostic, Clinical)
•Reflex Threshold (Diagnostic, Clinical)
•Reflex Decay (Diagnostic, Clinical)
•ETF-I (Eustachian Tube Function - Intact) (Diagnostic, Clinical)
•ETF-P (Eustachian Tube Function - Perforated) (Clinical)
•Admittance Recording (multiple uses, e.g., patulous Eustachian Tube evaluation, acoustic reflexes with external
stimulus) (Diagnostic, Clinical)
•Manual Tympanometry (Diagnostic, Clinical)
•Viewing tympanogram history (Diagnostic, Clinical)
Operating Madsen Zodiac
•Stand-alone Zodiac
Use Zodiac as a stand-alone unit using 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.

2 Unpacking and installation
7
Madsen Zodiac
•PC-based Zodiac
You can operate the PC-based version of Zodiac using the PC’s keyboard and mouse with the Otosuite Immittance
module acting as the display.
Probes
Madsen Zodiac supports the following probes:
•The hand-held Quick Check probe: Madsen Zodiac Quick Check, and Madsen Zodiac Diagnostic and Clinical
•The two diagnostic probe types, Classic and Comfort: Madsen Zodiac Diagnostic and Madsen Zodiac Clinical
•A contralateral insert phone or TDH-39 supra-aural phone: Madsen Zodiac Diagnostic and Madsen Zodiac Clinical
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.
1.1 The Otosuite Immittance module
The Otosuite Immittance module offers real time presentation of test results and full test control of MADSEN Zodiac
directly from a PC. Stand-alone versions of Zodiac, which have integrated user interfaces, can be operated independently
of the Immittance module, although additional features and diagnostic value are offered by the Immittance module's
comprehensive userinterface and NOAH compatibility.
When used for testing, the Otosuite Immittance module adapts to the connected test device. The test functionalities of
the Otosuite Immittance module depend on the connected device, as does the selection of test parameters and remote
control.
The Immittance module functions are described in Testing with Zodiac Diagnostic or Clinical - PC-based 82.The
Otosuite Immittance module lets you work with NOAH or save and view results via XML files.
Supported tests
Depending on the Zodiac connected to Otosuite, the Otosuite Immittance module supports the following tests and
functionalities:
•Tympanometry (Quick Check, Diagnostic, Clinical)
•Reflex Screening (Quick Check, Diagnostic, Clinical)
•Reflex Threshold (Diagnostic, Clinical)
•Reflex Decay (Diagnostic, Clinical)
•ETF-I (Eustachian Tube Function - Intact) (Diagnostic, Clinical)
•ETF-P (Eustachian Tube Function - Perforated) (Clinical)
•Admittance Recording (multiple uses, e.g., patulous Eustachian Tube evaluation, acoustic reflexes with
external stimulus) (Diagnostic, Clinical)
•Manual Tympanometry (Diagnostic, Clinical)
•Viewing tympanogram history (Diagnostic, Clinical)
Madsen Zodiac - Otosuite interfacing
Madsen Zodiac operates with the Otosuite Immittance module. Use the Noah compatible Otosuite Immittance module
to perform tests, monitor test results, create User Tests, store and export data, and print reports.

2 Unpacking and installation
8
Madsen Zodiac
General features
Depending on the configuration of Madsen Zodiac and the Immittance module, you can:
•perform a range of immittance tests
•view the progression of the tests online
•view and print test results
•view historic tympanometry results
•upload test results from tests performed while Zodiac was offline
1.2 Intended 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.
1.2.1 Contraindications
2
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.

2 Unpacking and installation
9
Madsen Zodiac
Warning • Local government rules and regulations, if applicable, should be always followed.
1.3 About this manual
This guide is about Madsen Zodiac and the Otosuite Immittance module. It introduces the key features with working
scenarios for performing tests and viewing and printing test results.
Read this manual and become familiar with Madsen Zodiac and how it operates with Otosuite before testing on a client.
If you are using Otosuite with Noah, we recommend that you are familiar with the screens and functions provided in Noah.
Safety
This manual contains information and warnings which must be followed to ensure the safe performance of Madsen Zodiac.
Safety information is stated where it is relevant, and general safety aspects are described in Standards and warnings 120.
Installation
•To install the new system, see Installing Zodiac 10.
•To install Otosuite, see the Otosuite User Guide.
Configuring the Otosuite Immittance module
•See Configuring the Immittance module 13.
Basic Otosuite functions
Basic Otosuite functions are described in the Otosuite User Guide.
Operating Zodiac
•Testing with Zodiac Quick Check - Stand-Alone 38
•Testing with Zodiac Diagnostic or Clinical -Stand-Alone 43
•Testing with Zodiac Quick Check - PC-based 78
•Testing with Zodiac Diagnostic or Clinical - PC-based 82
1.4 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:
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.

2 Unpacking and installation
10
Madsen Zodiac
1.5 Navigating this manual
Menus, icons and functions to select are shown in bold type, as for instance in:
•Click the Set options icon on the toolbar or select Tools > Options
2Unpacking and installation
To install and get started with Madsen Zodiac and the Otosuite Immittance module, follow the sequence below:
•Unpack Madsen Zodiac (see Unpacking 10).
•Install Otosuite on the PC. See the Otosuite Installation Manual on the Otosuite Installation disk.
•Install Madsen Zodiac (see Installing Zodiac 10).
•Run the Otosuite Configuration Wizard to connect to and set up communication with Madsen Zodiac. (See
Configuring the Immittance module 13).
2.1 Unpacking
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 possible damage.
If the device is damaged, do not use it. Contact the Natus representative for assistance.
3. Verify the contents. If the package is incomplete, contact the Natus representative.
2.2 Storing
If you need to store Madsen Zodiac before use:
•Store Madsen Zodiac and accessories in the boxes provided to protect the equipment from damage.
•Store Madsen Zodiac and accessories in a dry environment.
2.3 Installing Zodiac
To ensure safe performance of the device, follow the Warning notes for installation.
See Warning notes 123.
Location
Perform immittance testing in a quiet room. A sound cabin or sound treated room is not necessary.
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).
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).