otometrics MADSEN OTOflex 100 User manual

MADSEN OTOflex 100 &
OTOsuite Immittance Module
User Guide
Doc. No.7-50-1590-EN/03
Part No.7-50-15900-EN

Copyright notice
© 2015,2019Natus MedicalDenmark ApS. All rights reserved. ® Otometrics, the OtometricsIcon, AURICAL, MADSEN, Otoscan,
ICS and HORTMANN are registered trademarks of Natus MedicalDenmark ApS in the U.S.A. and/or other countries.
Version release date
2019-06-18 (214183)
Technical support
Please contact your supplier.
Otometrics - MADSEN OTOflex 100
2

Table of Contents
1 Description 4
2 Intended use 4
3 Unpacking 5
4 Installation 5
5 Handling and switching MADSEN OTOflex 100 on and off 11
6 OTOsuite toolbar icons and test controls 11
7 The MADSEN OTOflex 100 keypad 13
8 The MADSEN OTOflex 100 menu 14
9 The MADSEN OTOflex 100 text editor 15
10 Preparing for testing 17
11 Fast routine testing 22
12 Sequence testing 22
13 Screening 23
14 Diagnostic Tympanometry 24
15 Acoustic Reflex testing 26
16 Managing test results in MADSEN OTOflex 100 33
17 Other references 35
18 Service, cleaning and calibration 35
19 Technical specifications 40
20 Definition of symbols 47
21 Warning notes 50
22 Manufacturer 52
Otometrics - MADSEN OTOflex 100 3

1 Description
MADSEN OTOflex 100
MADSEN OTOflex 100 is a compact and portable wireless immittance test device.
• You can operate MADSEN OTOflex 100 from the PC’s
keyboard/mouse with the OTOsuite Immittance mod-
ule acting as the display, or operate the device itself as
a stand-alone unit.
• From the OTOsuite Immittance module, which is NOAH
compatible, you can monitor test results, create User
Tests, store and export data, and print reports.
Bluetooth
MADSEN OTOflex 100 connects with OTOsuite via BluetoothTM, which provides wireless connection between MADSEN
OTOflex 100 and OTOsuite up to a range of approximately 10 metres (approx. 33 ft).
2 Intended use
MADSEN OTOflex 100 and the Immittance module
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 OTOflex 100 uses technologies which 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.
The MADSEN OTOflex 100 probe is extremely lightweight (only 4.5 grams), and comes with comfortable, easy to insert ear-
tips. This makes it ideal for use with children and adults.
MADSEN OTOflex 100 can be configured for a wide variety of tests, and it can be operated entirely manually or pro-
grammed for the user’s own combination of manual and automatic operation. In user-programmable tests the user can
select the default parameters of a particular test, and combine tests to form a sequence of preset tests.
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:
Warning •Indicates that there is a risk of death or serious injury to the user or patient.
4 Otometrics - MADSEN OTOflex 100
1 Description

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 Natus MedicalDenmark ApS (www.natus.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
Install OTOsuite on the PC before you connect to MADSEN OTOflex 100 from the PC.
For OTOsuite installation instructions, see the OTOsuiteInstallation Guide, on the OTOsuite installation medium.
•Desktop installation ►7
•Desktop installation ►7.
Otometrics - MADSEN OTOflex 100 5
3 Unpacking

4.1 Wall mount installation
1. Drill 2 x 6 mm diameter holes 130mm (5.12") apart.
2. Insert rawl plugs.
3. Insert the screws with the washers mounted, through
the backplates of the wall mount.
A. 2 screws
B. 2 washers
C. 2 rawl plugs
D. washer
E. wall mount backplate
F. plastic shelf
6 Otometrics - MADSEN OTOflex 100
4 Installation

4.2 Desktop installation
Mount the charger on the charger base
as shown below.
1. Use the hexagonal key to screw the
hexagonal screws into place.
2. Tighten the screws well so that the
charger is stable when you place
MADSEN OTOflex 100 in the char-
ger.
A. Charger body
B. Charger base
C. Hexagonal screws
D. Hexagonal key
A. Base
B. Hexagonal key
4.3 Powering the device
MADSEN OTOflex 100 is powered by batteries.
• Rechargeable NiMH batteries
The device is delivered with rechargeable NiMH batteries.
• Alkaline batteries
If needed, the device can be powered by non-chargeable Alkaline batteries.
Otometrics - MADSEN OTOflex 100 7
4 Installation

Caution •Use only the battery types listed in Technical specifications ►40.
Inserting batteries
1. The batteries and the battery cover are delivered in a small bag.
Note •Do not insert the battery cover in the battery compartment if the battery compartment is empty. If you do, the
cover will lock in place inside the device.
2. Insert the batteries as shown. If you are in
doubt, look inside the battery com-
partment where you will see small red plus
signs indicating which way the batteries fit.
3. To put the battery cover back in place,
insert the cover with the curved edge
facing upwards in the opening. Press the
cover inwards and downwards until it clicks
into place.
4. The next time you change batteries, press
the cover inwards and upwards until it is
released and snaps out of place.
Set the battery type in the device
The device is delivered preset for rechargeable NiMH batteries.
Warning •If you use the device with Alkaline batteries, always switch off the mains power supply to the charger. Fail-
ure to do so may cause the Alkaline batteries to leak and cause damage to the device.
1. If you are in doubt of the setting, or if you are using Alkaline batteries, check the battery type and the setting in the
device: When MADSEN OTOflex 100 is ready for use, switch it on: Press and hold the On/Off key on the keypad.
2. Press Select to access the Menu followed by Advanced.. >Device Settings.. and scroll to Battery type.
3. Press Select to toggle to the correct battery type. You can choose between NiMH (rechargeable) and Alka(line).
4. Press the left softkey to exit.
8 Otometrics - MADSEN OTOflex 100
4 Installation

5. If needed, press and hold the On/Off key on the keypad to switch off the device.
Power indicator
An icon in the the top right corner of MADSEN OTOflex 100 shows the type of powering used.
MADSEN OTOflex 100 receives power from the charger.
MADSEN OTOflex 100 is powered by batteries.
4.4 Powering the charger
Connecting the charger to the mains power outlet
Warning •Operating at the wrong voltage may blow the fuses!See the label on the charger for input voltage.
1. Before you connect the power cable to the charger, make sure that the
voltage from the electrical power outlet matches the voltage shown on
the identification label on the charger.
2. Connect the charger to the mains power outlet. The device is
delivered preset for rechargeable NiMH batteries.
3. When you are not using the device, leave it in the charger so that it is
always ready for testing.
Warning •If you use the device with Alkaline batteries, always switch
off the mains power supply to the charger. Failure to do so may cause
the Alkaline batteries to leak and cause damage to the device.
A. Power socket
Charging the device
See Powering the device ►7.
1. Insert rechargeable NiMH batteries in the device.
1. Place the device in the charger.
2. Leave the device to charge for at least 14 hours, and preferably
overnight, before putting it into use.
The batteries will reach full capacity when they have been recharged a
couple of times.
A. Charger tab for charging the device
B. Charging indicator
C. Probe test cavity
D. The charger base
Otometrics - MADSEN OTOflex 100 9
4 Installation

Charging status
When the device is charging, the charging indicator on the front of the charger indicates the following:
Green, steady: The device is not charging. Charging is resumed when the device is reinserted into the char-
ger or the device is turned on.
Amber, steady: The device is charging. Charging is discontinued automatically based on a timer to ensure
that batteries are not over-charged.
Amber, flashing: The charger is faulty. Contact your supplier.
Device status
Powered by charger When the device is charging, a small power plug icon is shown in the top
right corner of the screen.
Powered by batteries
only
When the device is powered by batteries only, i.e. when it is not placed in
the charger or when Alkaline batteries are used, it shows the approximate
remaining capacity of the batteries in the top right corner of the screen.
4.5 Connecting MADSEN OTOflex 100 to OTOsuite
When you use MADSEN OTOflex 100 for the first time, run the Configuration Wizard to set up the connection between
MADSEN OTOflex 100 and OTOsuite. After you have configured OTOsuite for the first time, if MADSEN OTOflex 100 is
turned on when you open the Control Panel in OTOsuite, then MADSEN OTOflex 100 will connect to OTOsuite auto-
matically. Otherwise, you can connect MADSEN OTOflex 100 as follows:
1. Switch on the device.
2. Launch OTOsuite.
3. In the OTOsuite toolbar, click Control Panel.
4. In the Control Panel, click Connect.
10 Otometrics - MADSEN OTOflex 100
4 Installation

5 Handling and switching MADSEN OTOflex 100 on and
off
A. Probe
B. Probe plug
C. Screen
D. Keypad
Handling
To operate MADSEN OTOflex 100, hold it with one hand (left or right). Use your
thumb to press the keys on the keypad and turn the scroll wheel.
Switching on MADSEN OTOflex 100
Press and hold the On/Off key on the keypad until the start-up screen
appears.
Switching off MADSEN OTOflex 100
Press and hold the On/Off key on the keypad until the message “Power Off”
appears.
6 OTOsuite toolbar icons and test controls
Immittance module toolbar
The icons available in the toolbar depend on the test function that you have selected.
General Immittance icons
Get Test Results from device (Ctrl + G)
Opens the dialog box for uploading patient folders from the test device.
Select Device
Opens the dialog box for selecting a specific test device.
Otometrics - MADSEN OTOflex 100 11
5 Handling and switching MADSEN OTOflex 100 on and off

Tympanometry toolbar
Show Previous Curves/Show Next Curves
Toggles between specific curves on the tympanogram.
Admittance is selected - change to Conductance/Susceptance
Conductance/Susceptance is selected - change to Admittance
Toggle to see the admittance components conductance and susceptance, or admittance data.
Auto Scale (tympanogram)
Click to select/deselect autoscaling of a tympanogram in order to display the entire
curve.When you change the ear or the patient, the scale will revert to the default scale.
Reflex toolbar
Show Previous Curves/Show Next Curves
Toggles between the visible reflex curves.
Test controls
Starts/pauses a sequence.
Starts a test.
Starts a fully automatic reflex test.
Starts a semi-automatic reflex test.
Starts stimulus to present a single stimulus intensity.
Stops the test immediately.
Pauses the progress of a sequence. When this button flashes, click again to resume testing.
Skips the ongoing measurement and continues with the next.
Controls pressure in ETF-P.
12 Otometrics - MADSEN OTOflex 100
6 OTOsuite toolbar icons and test controls

7 The MADSEN OTOflex 100 keypad
MADSEN OTOflex 100 has 1 scroll wheel and 5 keys.
•Scroll wheel
– Turn the scroll wheel to the right or left to highlight areas on the screen.
•Keys
– Press and release the keys to activate most functions.
– Press and hold the keys for instance to turn the device on or off, or to run a full test
sequence.
Key Function
•On/Off
– Press and hold this key to turn the device on or off.
•Select test screen
– Press this key to toggle between the test screens Tympanometry, Reflex Screening, Reflex
Threshold, Reflex Decay, and ETF-P
•Select ear
– Press this key to select the ear to be tested, or the ear to be reviewed (when you view data ).
•Pressure release during testing
– If the patient is troubled during testing, press this key to stop the test.
•Select a menu item
– Selects an item from the menu
– Activates the scroll function
– Toggles between test screens and menu screens.
•Enter the menu
– Activates the menu from the Tymp or ETF screens. Scroll to move between choices, and then press
this key to select. Press the right softkey to return to the Tymp or ETF screen.
•View tympanometry data
– In the Tymp screen, press and hold this key to select tympanometry data view.
Press and hold this key to return to the Tymp screen.
– Press and hold this key to activate the scroll wheel in the Tymp Data and Tymp test screens.
Selects a test screen and deactivates the scroll wheel.
Otometrics - MADSEN OTOflex 100 13
7 The MADSEN OTOflex 100 keypad

Key Function
•Softkeys
Press these keys to select whatever is shown on the screen directly above the key.
–Example:
If is shown above the left key, press this key to toggle between curves 1, 2, or 3.
– Press the left-hand key to return to the previous screen when is displayed.
– Press the right-hand key to go directly to the testing screen when is displayed.
– Press and hold the left-hand key to view patient, user, and device information.
– Press and hold the right-hand key to start an entire test sequence.
•Scroll wheel
– Scroll to highlight the Menu icon ( ) and press the Select key to select.
– Scroll to highlight menu items or test options. Press the Select key to select.
– Scroll to move between tests within a sequence.
– Highlight an item you wish to select within a Reflex screen, e.g a single frequency, and press the
Select key to scroll through presentation levels.
– Scroll to increase or decrease a selected value.
8 The MADSEN OTOflex 100 menu
Main menu Function
Start Sequence For starting a sequence of tests.
Test Selector For selecting the test you wish to perform. See Using a test setup ►20.
Print/Printers.. For selecting direct printout.
Patient & User For entering patient and user information. See The MADSEN OTOflex 100 text editor ►15.
My Settings.. For loading settings or saving current settings.
Done! For selecting the Done! prompt. This prompt appears whenever a step in the test procedure
has been done, and takes you to the next step. See Test flow setup ►20.
Probe Check For selecting the probe check, which should be carried out daily. See Daily probe check ►
18.
14 Otometrics - MADSEN OTOflex 100
8 The MADSEN OTOflex 100 menu

Main menu Function
----
----
For selecting frequently used settings for the displayed test type.
More settings.. For selecting additional settings for the displayed test type.
Manage Test Res(ults) For loading a previously tested patient, deleting tests, etc. See Managing test results in
MADSEN OTOflex 100 ►33.
Procedure options.. For setting up routine testing.
Advanced.. For selecting advanced features.
9 The MADSEN OTOflex 100 text editor
If you are testing using MADSEN OTOflex 100 as a stand-alone device, use the text editor to enter patient data in MADSEN
OTOflex 100.
Entering data
In some screens you can enter text and numeric values.
Keypad Function
Left softkey Cancel
• Do not use the edited text
Right softkey OK
• Accept the edited text
Select
• Press to access field
• Press to enter character
• Press and hold to enter character selection mode
Scroll wheel
• Scroll to highlight field
• Scroll to select character
1. Scroll to the field where you wish to enter data.
2. Press Select to access the field. The field displays a small highlighted square.
3. Turn the Scroll Wheel until the desired digit or letter is displayed and press Select.
4. Continue until you have entered the data.
5. Press OK to confirm.
6. Turn the Scroll Wheel to go to the next field, and press Select to access the field.
Otometrics - MADSEN OTOflex 100 15
9 The MADSEN OTOflex 100 text editor

7. If you need to move the cursor to insert or delete letters/digits in the data field, see below for editing entered data.
Editing data
You can edit data in the Patient & User screen.
Keypad Function
Left softkey DEL (Delete)
• Press to delete character
Right softkey INS (Insert)
• Press to insert space for a character
Character selection enabled
Select
• Press to return to character entry mode
Scroll wheel
• Scroll to highlight character
• Scroll to select character
1. Scroll to the field you wish to edit and press Select to access the field.
2. Press and hold Select to access character selection mode. The bottom of the screen shows double arrows to
indicate that you can scroll to the desired position in the field.
Editing characters
1. Scroll to the desired position.
2. Press Select and scroll to change the character as needed.
Deleting characters
1. To delete a character, scroll to the character to be deleted.
2. Press the DEL (Delete) softkey.
Editing settings
1. Scroll to the setting you wish to change.
There are two main methods of editing data such as measurement settings:
–Settings with two value options
Press Select to toggle the value in the settings field.
–Settings with several value options
Press Select to access the settings field, and use the Scroll Wheel to scroll to the desired setting.
16 Otometrics - MADSEN OTOflex 100
9 The MADSEN OTOflex 100 text editor

10 Preparing for testing
To prepare for testing:
• If this is the first test of the day, make a probe check.
• Connect the probe, and, if needed, the insert phone.
• Prepare MADSEN OTOflex 100 and the Immittance module: select the patient and test setup. See the OTOsuiteUser
Guide.
• Prepare the patient.
• Prepare probe and eartip.
10.1 Preparing the probe
Connecting the probe
1. The probe
A. Probe body
B. Threaded ring
C. Probe tip
2. The probe plug
D. Air connector
E. Transducer connector
Top of device
A. Contralateral socket
B. Pneumatic connection
C. Probe socket
Otometrics - MADSEN OTOflex 100 17
10 Preparing for testing

Connecting probe and insert phone
The MADSEN OTOflex 100 probe • Plug the probe into the probe socket.Make sure that
you insert the pin for the pneumatic pump into the
pneumatic connection.
The E-A-RTONE® 3A insert phone • If needed, plug the E-A-RTONE® 3A insert phone into
the contralateral socket.
Disconnecting probe and insert phone
The probe plug and the contralateral plug are equipped with a locking mechanism: When you disconnect the probe, do
not pull the plug by the cable. Grip the probe by the sleeve of the plug and free it by gently pulling it out of the socket.
10.2 Daily probe check
To make sure that the probe is functioning correctly, it is recommended that you perform a probe check at the start of
each day.
Note •If your test environment changes, for instance if there is an increase in humidity, or if you are going to test at
an altitude different from the one set in MADSEN OTOflex 100, adjust the altitude setting and make another probe
check.
1. Make sure that the probe tip has been cleaned
and disinfected before you place it in the test
cavity. This is to make sure that the probe tip
and filter do not influence the probe test, and
that the test cavity is not contaminated.
2. Select Menu >Probe Check.
3. Insert the probe tip without eartip in the test
cavity in the charger. The probe check starts
automatically. The probe is checked for occlu-
sion and leakage. If the probe is OK, the probe
is automatically calibrated to 2cc.
If there is a probe error
In case of a probe error, check the following:
• Make sure that the threaded ring holding the probe tip in place is firmly tightened.
• Make sure that the sound channels in the probe tip are clear and that the probe is connected.
• Make sure that the probe tip goes into the cavity at a 90° angle.
If the probe is faulty, contact an authorized service department for repair.
18 Otometrics - MADSEN OTOflex 100
10 Preparing for testing

10.3 Fitting the eartip on the probe
Warning •Choking hazard! Do not leave eartips unsupervised within the reach of children.
Note •Accurate testing is only guaranteed if you use the eartips approved specifically for MADSEN OTOflex 100 by
Otometrics.
Note •Check the sound channels in the probe tip every time you have used the probe.Even small amounts of cerumen
or vernix can block the sound channels. Clean the sound channels if needed.
Warning •The eartip can be used for both ears. If you suspect infection in one ear, exchange the eartip and clean the
probe tip before you continue testing on the other ear.
1. Select an eartip that fits the patient’s ear canal.
2. Gently push and twist the eartip clockwise onto the probe tip, until it rests firmly against the base of the probe.
Make sure that the eartip covers the collar (C) of the probe tip.
10.4 Fitting the probe in the patient's ear
Warning •The eartip can be used for both ears. If you suspect infection in one ear, exchange the eartip and clean the
probe tip before you continue testing on the other ear.
1. Fit the eartip on the probe.
2. 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 downwards and back.
3. Insert the probe in the patient's ear canal, twisting the eartip slightly as you insert it.
4. Make sure that the eartip fits well. Any leakage may interrupt the test.
Otometrics - MADSEN OTOflex 100 19
10 Preparing for testing

Caution •Never insert the probe without a suitably sized eartip. Using a probe with an unsuitably sized eartip or
applying excessive force may irritate the ear canal.
Warning •Be careful not to insert the probe too far into the ear canal of premature babies and newborns.
To compensate for spontaneous movements of the patient’s
head:
– Place the probe cable behind the patient’s neck.
– To keep the cable in place, place a weighted shoulder
harness over the cable, from front to back of the patient,
across the shoulder opposite the ear being tested.
– Make sure that the cable is not drawn tight, as this may
result in the probe being pulled out of position.
During testing, MADSEN OTOflex 100 and the Immittance module will show a probe icon indicating leakage, if any.
10.5 Test flow setup
1. When you switch on the device, a new patient folder is created automatically.
2. The Patient & User screen is shown. Enter the patient and user data .
3. Set up MADSEN OTOflex 100 to facilitate the process of testing, handling patient data, and continuing with the next
patient:
– Select Menu >Procedure options.. >
– Set the following settings to On, if needed:
Setting What happens if On is enabled?
Done? prompt The Done? prompt will appear when you have performed the same number of tests
on both ears. of the patient.
Print when done? The results will be printed if you press Yes in response to the prompt.
When printing is done, the Done? prompt reappears. Select Yes to continue.
A new patient folder is created.
Patient The Patient & User screen appears for creating a new patient folder.
Settings prompt When you have entered patient data, the Load Settings screen appears if any cus-
tomized setups are available.
Select the test setup of your choice, and continue with testing.
4. If needed, press the On/Off key one or more times to select another test type.
10.6 Using a test setup
If you want to use a test setup different from the one currently selected, do one of the following:
20 Otometrics - MADSEN OTOflex 100
10 Preparing for testing