MADSEN Zodiac

MADSEN Zodiac

Service Manual

Doc. No.7-50-1620-EN/02

Copyright notice

© 2016, 2016 GN Otometrics A/S. All rights reserved. ® Otometrics, the Otometrics Icon, AURICAL, MADSEN, ICS and HORTMANN are registered trademarks of GN Otometrics A/S in the U.S.A. and/or other countries.

Version release date

2016-10-06 (143849)

Technical support

Please contact your supplier.

2 Otometrics - MADSEN Zodiac

Table of Contents

1

Introduction to MADSEN Zodiac

1.1

The purpose of this Service Manual

1.2

Installation and Assembly

1.3

Power-on test

1.4

Safety

1.5

Equipment failure

2

Troubleshooting

2.1

Powering problems

2.2

Communication problems

2.3

Probe-fit related problems

2.4

Printer-related problems

3

System description

3.1

Main board

3.2

Pump assembly

3.3

Keypad controller

3.4

Display

3.5

Printer controller

4

Calibration/adjustment

4.1

Calibration tools

4.2

Probe check

4.3

Probe admittance calibration

4.4

Accessing the calibration application

4.5

The calibration application

4.5.1 The Information tab

4.5.2 The Pressure tab

4.5.3 The Levels tab

4.5.4 The Admittance tab

4.5.5 The Certificate tab

5

Updating the device firmware

6

Service and repair

6.1

Service plans

6.2

Service parts

Otometrics - MADSEN Zodiac

10

10

10

10

10

10

8

9

8

8

9

5

6

7

7

7

7

14

15

16

16

11

12

13

17

18

19

19

20

21

21

22

3

7

Technical specifications

8

Accessories

9

Notes on EMC (Electromagnetic Compatibility)

10 Standards and symbols used

11 Warning notes

12 Manufacturer

12.1 Responsibility of the manufacturer

Index

31

34

35

37

37

38

23

30


1 Introduction to MADSEN Zodiac

This section introduces you to MADSEN Zodiac as well as to this Service Manual.

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).

Configurations

MADSEN Zodiac is available as

• a user-operated immittance device, or

• as a PC-based device.

MADSEN Zodiac can be placed on the desk top, or, if the optional kit is used, it can be mounted on the wall.

MADSEN Zodiac Quick Check - Stand-Alone

MADSEN Zodiac Diagnostic and Clinical - Stand-

Alone

MADSEN Zodiac Quick Check - PC-based

MADSEN Zodiac Diagnostic and Clinical - PC-based

Operating MADSEN Zodiac

• Stand-alone Zodiac

You can operate 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 operate Zodiac using 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.

• 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

Depending on the configuration, MADSEN Zodiac supports the following probes:

• The Quick Check probe can be used with MADSEN Zodiac Quick Check, and with MADSEN Zodiac Diagnostic and Clinical.

Otometrics - MADSEN Zodiac 5


1.1

• The two diagnostic probe types, Classic and Comfort, can be used with MADSEN Zodiac Diagnostic and MADSEN

Zodiac Clinical.

• A contralateral insert phone or TDH-39.

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.

Hardware and firmware

Besides the hardware, MADSEN Zodiac contains firmware, device serial number and a calibration.

The purpose of this Service Manual

This Service Manual describes service parts that are approved as replaceable. See

Service plans ► 21

.

MADSEN Zodiac contains no parts that can be repaired or replaced on a component level. In practice this means that servicing the device is limited to replacement of the approved service parts on a modular basis.

The section

Troubleshooting ► 8

describes issues that may relate to the performance of the device, and suggests actions for solving them.

This Service Manual also describes calibration of MADSEN Zodiac and probes, and is intended as a help for skilled service technicians in calibrating and verifying the performance of MADSEN Zodiac.

Caution • The manufacturer reserves the right to disclaim all responsibility for the operating safety, reliability and performance of equipment service or repaired by other parties. Following repair, a qualified electronics engineer should verify the safety of all equipment

Warning • For safety and in order not to void the warranty, the MADSEN Zodiac cabinet should only be opened, service and repaired by authorized service personnel at authorized workshops.

Warning • In case of any defects, please make a detailed description of the defect(s) and contact your local distributor.

Warning • Never use a defective device!



1.2

1.3

1.4

1.5

Installation and Assembly

Warning • MADSEN Zodiac and OTOsuite must always be installed in accordance with the instructions in the

MADSEN Zodiac Reference Manual/User Guide and the OTOsuite Reference Manual/User Guide.

The MADSEN Zodiac Reference Manual and User Guide contain instructions on how to unpack and assemble the device.

For instructions on installing the OTOsuite software, see the OTOsuite Installation Manual.

A few recommendations regarding handling and installation of the device are listed below:

• Make sure that the device is protected from repeated hard shocks and vibrations.

• Avoid sharp bends in the cables near plugs, buttons, sound transducers etc.

• Background noise and atmospheric pressure can affect the measuring accuracy of the device.

Power-on test

During power-on, the system carries out a range of power-on tests, mainly regarding the main board, the pump, calibration, and, depending on the configuration, the keyboard.

• If the test is successful, the connected probe will light up in one of the ear selection colors. If two probes are connected, the Quick Check probe will indicate the status of the test.

• If the probe lights up in green, this indicates that the probe has not been recognized.

If an error message appears, this indicates that there is a failure in the system. This will lock the device from being used.

Safety

This manual contains information and warnings which must be followed to ensure the safe performance of MADSEN Zodiac.

Warning • Local government rules and regulations, if applicable, should be followed at all times.

Safety information is stated where it is relevant, and general safety aspects are described in the MADSEN Zodiac Reference

Manual and User Guide.

Equipment failure

If you believe that the correct function or operating safety of the device is impaired in any way, disconnect it from the power supply and secure it against further use.


8

2 Troubleshooting

2

2.1

2.2

Troubleshooting

Powering problems

Problem

An error message appears during power-on.

MADSEN Zodiac does not power on even though I press the on/off button.

Possible cause

• No probe is connected.

• No connected probe lights up in an ear selection color, or lights up in green.

• There may be an error in the main board, the pump, calibration, or, depending on the configuration, the keyboard.

The power supply cables are not connected properly.

The On/Off light indicator is not lit.

There is no power supply to the device.

There is no power supply to the device.

The display does not light up when I power on the device.

Solution

• Switch off the device, connect the probe, and switch on the device again.

• The probe was not recognized by the system during power-on. Check the probe, probe cables and probe connection.

• An error code will indicate the type of error. Remedy the error.

Make sure that the cables of the power supply are firmly connected to the device and the mains outlet socket.

Make sure that the mains supply is switched on, if applicable.

Make sure that the mains supply is switched on, if applicable.

Communication problems

Problem Possible cause Solution

During installation, the installation process may be interrupted. Various error messages may occur

When OTOsuite is launched, one or more error messages may appear regarding XML errors.

The PC's virus scan is active and prevents the installation process from progressing.

An earlier version of OTOsuite was installed. An extended version of data sets has been installed with the new version of

OTOsuite.

Deactivate the PC virus scan until the installation process is completed.

Accept the error message. This message only appears the first time the new version of OTOsuite is launched.


2 Troubleshooting

2.3

2.4

Problem

There is no connection to the device.

The connection to the device is sometimes lost.

Air hose/cable connection problems.

Possible cause

The USB cable connecting the device to the PC was connected prior to installing OTOsuite. This results in a Windows default driver being allocated.

The USB cable is defective or longer than 3 meters.

Solution

1. Select the Windows Device Manager followed by Universal Serial Bus controllers.

The faulty connection will be marked by a yellow question mark in the list.

2. Uninstall the driver.

3. Make sure that OTOsuite is installed and relaunch OTOsuite.

Use a new cable. Using a powered USB hub can serve to extend the cable length.

Make sure that the cable from the device to the probe has not been damaged.

Make sure that the cable has not been pulled out of its connector on the bottom of the device.

Probe-fit related problems

Problem

Leakage

Possible cause Solution

Leakage can be caused by a number of factors,.

• Pneumatic plug or probe plug not inserted properly

• Wrong eartip size (either too small or too large)

• Ear canal debris blocks for good eartip seal.

See the User Guide or the Reference Manual for a description of probe status and leakage.

Printer-related problems

Problem Possible cause

The quality of the print-out is poor.

• An incorrect paper quality is being used.

• There is paper dust in the paper compartment .

• The print head or platen is dirty.

The printer does not print.

The paper roll is not correctly placed in the printer compartment.

Recommended action

Make sure that you are using the paper quality listed in

Accessories ► 30 .

Clean the paper compartment. Cleaning is described in the MADSEN

Zodiac Reference Manual.

Make sure that the paper roll is correctly placed in the printer compartment.


3 System description

3.4

3.5

3

3.1

3.2

3.3

System description

Main board

The main board contains the MCU (MicroController Unit) that handles all signal processing and controls the CODEC

(ADC/DAC converters), pump, USB interface, and, depending on the configuration, display, keypad controller, printer/printer controller, etc.

Pump assembly

The pump assembly contains the stepper motor, the pump, an acoustic silencer, two valves, a position sensor and a pressure sensor.

The stepper motor is controlled from the main board. The position sensor is located on a separate PCB on the pump unit.

The pressure sensor is located on a second, separate PCB.

The pump provides the air pressure used during the measurements.

Keypad controller

The Stand-Alone configuration of Zodiac has a front panel with a number of test control buttons, and, depending on the configuration, a dial. For a description, see the relevant User Guide. The keypad controller controls the test control buttons and LEDs, and is connected to the main board with a single cable.

Display

A 7 inch, 15:9 WVGA, 800 x 480 pixel display interfaces with the main board through two cables.

Printer controller

The printer controller, which is located on a separate circuit board below the printer mechanism, controls the mechanical printer unit. It is connected to the main unit with two cables, and to the printer mechanism with two cables.


4

4 Calibration/adjustment

Calibration/adjustment

This section will guide you through probe check and calibration of MADSEN Zodiac, the Zodiac immittance probes, and the contralateral insert phone and supra-aural phone.

The device and the probes are delivered fully calibrated.

• The device is calibrated from the factory in dB SPL or dB HL using the stated reference equivalent thresholds. dB HL are related to sound pressure levels, dB SPL = dB re 20

µ

Pa.

• The probe calibration values are saved in the probe assembly and follows the probe. The probe can be plugged to any

MADSEN Zodiac and used right away. This also applies to the contra insert phone.

The immittance probes and contralateral transducer(s)

Note • When you calibrate a transducer, you must complete the procedure before new data is saved.

The immittance probes and contralateral transducers have a built-in calibration chip, and can be connected to the device without calibration as long as the pressure system in the device is within the annual recalibration period.

When should you perform a probe check?

A probe check can be performed by all users. We recommend that you perform a probe check:

• before you use the device and probe(s) the first time

• if there is a change in the barometric pressure.

• if you are using the device at an altitude different from where the last probe check was carried out

When should you perform an admittance calibration of Zodiac and probes?

An admittance calibration can be performed by all users. We recommend that you perform an admittance calibration of

Zodiac and probes:

• when first you install the device

• if you replace a probe

• as part of the annual calibration

• if the probe check result does not show a value of 1.9 - 2.1 mmho/cc/ml at 226 Hz.

Procedures

1. The recommended sequence of selections from the Calibration menu is:

–

–

–

Probe check ► 13

Probe admittance calibration ► 14

The calibration application ► 16

Annual calibration

The immittance device, probes, and contralateral phones must be calibrated once a year by an authorized service department.

Calibration environment

Calibration should always be performed in a low-noise environment.



4.1

Calibration tools

Tools for probe check and admittance calibration

• 2 cc cavity for probe check

• Multi-frequency cavity kit (0.5 cc, 2.0 cc, 5.0 cc, HF)

Standard calibration equipment


• Pressure sensor

• Sound level meter with calibrated microphone

• IEC 60126/ANSI S3.7 2 cc coupler

Zodiac immittance probe calibration

• Standard calibration equipment


• HA-1 adapter

• Plastic adapter for 2 cc coupler

(part no. 1-21-542)

• Eartip for mounting on probe to fit in the adapter (part no. 8-68-

31507)

Insert phone calibration



• HA-2 adapter

• Plastic connection tube for 2 cc coupler

TDH-39 contralateral phone calibration


• GRAS 1" microphone and preamplifier and ear

• 303/9A coupler or

• IEC 318 coupler



4.2

Probe check

Standard equipment

• 2 cc cavity or

• 2 cc cavity in the multi-frequency cavity kit

Procedure

To make sure that the probe is functioning correctly, it is recommended that you perform a probe check at the start of each day.

Caution • Always clean and disinfect the probe tip before you insert it into a test cavity.

Note • If the test environment changes, for instance if there is an increase in humidity or if you are going to test at a different altitude, make a probe check to verify that the system measures correctly.

Note • If the probe check result does not show a value of 1.9 - 2.1 mmho/cc/ml at 226 Hz, we recommend that you make an admittance calibration. See

Probe admittance calibration ► 14

.

1. Use a new probe tip, or 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 does not influence the probe test, and that the test cavity is not contaminated.

2. Insert the probe tip without eartip in the 2 cc test cavity.

3. Select the probe check function:

From Zodiac Quick Check - Stand-alone:

– Press the Probe Check button.

You may have to support the probe in the test cavity.

From Zodiac Diagnostic and Clinical - Stand-alone:

– Press the Special button and select Probe check .

From OTOsuite:

– Click the Probe check icon on the toolbar.



4.3

The probe check starts automatically. If it does not, press the Start button to start the check. If it does not, click the Start button to start the check.

The probe is checked for occlusion and leakage. If the probe check result shows a value of 1.9 - 2.1 mmho/cc/ml at 226 Hz, the probe is OK. If not, we recommend that you make an admittance calibration.

Additional probe admittance checks can be performed. See the MADSEN

Zodiac Reference Manual.

If there is a probe error

In case of a probe error, the probe may be occluded or faulty.

• If the probe is occluded, clean or replace the probe tip.

• If the probe is faulty, contact an authorized service department for repair.

Probe admittance calibration

We recommend that you carry out this type of calibration at least once a year.


You can calibrate Zodiac from the device or from OTOsuite.

Standard equipment


Performing Probe Admittance Calibration from Zodiac

1. Use a new probe tip, or 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 does not influence the probe test, and that the test cavity is not contaminated.

2. To access Probe Admittance Calibration from

MADSEN Zodiac, switch on the device and select Special > Calibration > Probe Admittance .

3. Select the probe type you wish to calibrate:Quick Check or Diagnostic.

4. When the probe light indicator shows that the probe is active, place the probe in the 0.5 cc test cavity of the multi-frequency cavity kit.

The calibration starts automatically.



4.4

5. A progress bar shows when the first calibration is done, and the probe light indicator turns green.

6. Remove the probe from the cavity and wait until the probe light indicator shows that the probe is active.

7. Repeat the procedure with the 2.0 cc and the

5.0 cc cavities.

If you are calibrating a Quick Check probe, do not calibrate the probe in the HF cavity.

When the probe has been measured in all four cavities, the admittance has been calibrated for the applicable frequencies.

If there is a probe error

In case of a probe error, check the probe status for possible causes.

If the probe is faulty, contact an authorized service department for repair.

Accessing the calibration application

Note • The calibration routine is available in English only.

Important • If you leave the Calibration application before saving the calibration, all new calibration data will be lost. Calibration can only be saved by using the Calibration application.

The calibration application can be accessed only from OTOsuite.

Accessing the Calibration application

1. To access the Calibration application, launch OTOsuite and select Tools > System > Service and Calibration. You will be prompted to enter a password.

2. Enter the password and click OK .

The default password is zodiac.

The first time you access the Calibration application you will be prompted to enter a new password. Change the password. The password must consist of one to eight characters.

Note • Remember to make a note of the new password for future reference.

3. The Calibration application is launched.



4.5

The calibration application


The immittance probes and contralateral transducer(s)

Note • When you calibrate a transducer, you must complete the procedure before new data is saved.

The impedance probes and contralateral transducers have a built-in calibration chip, and can be connected to the device without calibration as long as the pressure system in the device is within the annual recalibration period.

Procedure

1. Set up the device with the calibration tools listed in

Calibration tools ► 12 .

2. Launch the Calibration application as described in

Accessing the calibration application ► 15

.

4.5.1

3. If you are calibrating a Zodiac Diagnostic or Clinical, and the device is fitted with both a Quick Check probe and a diagnostic probe, select the probe type you wish to calibrate.

The Information tab

The Information screen displays a table with information about the current calibration of the device and probes.

The Probe saving status panel

The Probe saving status panel on the left-hand side of the screen shows the saved calibration status of the probe or contralateral transducer.



4.5.2

When all fields display a green check-mark, you have made a full calibration of the system. Elements that are not applicable in the configuration are grayed out.

Calibration ID used when saving

• Enter your calibration ID in the top field on the screen for use when you save calibration in the device and probes.

Saved Settings

The settings used in the calibration are saved in OTOsuite.

• You can export these settings to another installation of OTOsuite: Click Export and the settings will be saved to a file.

In the other installation of OTOsuite, click Import and import the file.

• You can reset to factory settings: Click Reset .

The Pressure tab

1. Click the Pressure tab.

Sensor Calibration

1. When you select the Pressure tab, the Sensor calibration tab is active.

2. Insert the probe in the pressure gauge.

3. Select the probe type you wish to calibrate in the Probe saving status panel.

4. Click Start in the Sensor Calibration screen.

5. In the right-most table column on the screen, enter the value shown on the pressure gauge display and press Enter or click Next/Enter .

6. You will be prompted to enter the next values. If needed, use the arrow keys to change the values and press Enter or click Next/Enter .

7. When you have entered a value in the last field in the column, press Enter or click Finish .

8. Click Save to save the calibration data in the probe and the device.

Manual Test

The manual test is intended for service and verification of the pump and pressure system in the device.

1. Click the Manual test tab.

2. Set the desired pressure on the sliding scale.

3. Click Start .

4. The pressure is shown on the screen.

Safety valve test

This test is for checking that the pressure in the probe does not exceed -800 daPa and +600 daPa.

1. Click the Safety valve test tab.

2. Select the probe type you wish to calibrate in the Probe saving status panel, and insert the probe in the 2 cc cavity.

3. Click the Test Negative Pressure Safety button to test the negative pressure, and then the Test Positive Pressure

Safety button to test the positive pressure.

4. The results are shown on the screen.



4.5.3

The Levels tab

1. Click the Levels tab.

2. Set up the probe for sound level calibration with the relevant coupler connected to the sound level meter (SLM).

–

–

Use final level reading

If this field is enabled, the final reading will be included in the Calibration Certificate.

Use frequency reading

If this field is enabled, the frequency reading will be included in the Calibration Certificate.

Probe tone

1. When you select the Levels tab, the Probe Tone tab is active.

Insert the probe into the HA-1 (2 cc) coupler with the sound level meter (SLM) connected.

2. Click Start .

3. Calibrate the probe tones by changing the applied correction, if needed.

To include the final reading from the SLM, click in the Final reading field and adjust.

Important • Keep the probe in the 2 cc coupler during the entire Probe Tone calibration.

4. Click Next to calibrate the subsequent probe tones. Repeat for the applicable frequencies.

5. Click Stop . If all probe tones have been played, the Save button is enabled and you can save the calibration.

6. Leave the probe in the coupler so that it is ready for the Ipsi Reflex Stimulus calibration.

Ipsi Reflex Stimulus

1. Click the Ipsi Reflex Stimulus tab.

2. Click to choose between SPL at 100 dB SPL, or HL at 95 dB HL.

3. Click Start .

4. Calibrate the 500 Hz, 1000 Hz, 2000 Hz, 3000 Hz, 4000 Hz, BBN, LBN, and HBN stimuli by changing the applied correction, if needed.


5. Click Next to calibrate the subsequent stimuli. Repeat for all signals.

6. Click Stop . If all signals have been played, the Save button is enabled and you can save the calibration.

Contra Reflex Stimulus

If you wish to calibrate a contralateral phone, do the following:

1. Click the Contra Reflex Stimulus tab.

2. Click to choose between SPL at 100 dB SPL, or HL at 95 dB HL.

3. Click to select the coupler you wish to use:

– For the contra insert phone you can choose between the HA-1 and the HA-2 coupler.

– For the supra-aural contra phone you can choose between the ANSI NBS 9A/IEC 60318-3 and the IEC 60318-1 EAS coupler.

4. Insert the phone into the desired coupler with the sound level meter (SLM) connected.

5. Click Start .



4.5.4

4.5.5

6. Calibrate the 500 Hz, 1000 Hz, 2000 Hz, 3000 Hz, 4000 Hz, BBN, LBN, and HBN stimuli by changing the applied correction, if needed.


7. Click Next to calibrate the subsequent stimuli. Repeat for all signals.

8. Click Stop . If all signals have been played, the Save button is enabled and you can save the calibration.

Note • Saving the calibration in the contralateral phone takes up to 30 seconds.

SLM microphone corrections

If you wish to use microphone corrections for your sound level meter, you can define them in this screen:

1. Click the SLM microphone corrections tab.

You can import or export a microphone correction file (.acm) for use by an Otometrics audiometer (AURICAL Aud or

MADSEN Astera² calibration application).

2. Click to enable the Use microphone correction function for probe tone, ipsi reflex and insert contra, as well as Supraaural contra phone. Values entered in this screen will be reflected in the Probe Tone tab, where the correction is shown as an SLM microphone correction column.

3. If needed, enter the desired values in the Properties fields.

4. If needed, enter the desired values in the Corrections fields.

The Admittance tab

1. Click the Admittance tab.

2. Select the probe type you wish to calibrate in the Probe saving status panel.

3. Insert the probe in the 0.5 cc cavity and click Start . Wait until the measurement is complete.



6. Insert the probe in the H.F. cavity and click Start . Wait until the measurement is complete.

7. Click Save to save the calibration in the probe.

The Certificate tab

1. Click the Certificate tab.

2. Click to select the elements you wish to include in the certificate: All , Device , Quick Check probe , Diagnostic probe , and Contra insert phone .

3. Enter values in the Technician , Environment , and Comments fields.

4.

5.

6.

If you export the settings file (in the Information tab) to another installation of OTOsuite, these values will be exported as well, and must be reviewed for possible adjustments.

Company logo :

You can enter a company logo image of your choice to be shown on the certificate. Browse to select the file.

View :

Click View to preview the certificate.

Save to PDF :

Click Save to PDF and save in a folder of your choice.


5 Updating the device firmware

5 Updating the device firmware

If the OTOsuite version contains a more recent firmware for your MADSEN Zodiac, a firmware update dialog is shown automatically when you connect MADSEN Zodiac to OTOsuite.

1. Follow the on-screen instructions.


6 Service and repair

6

6.1

Service and repair

Warning • For the sake of safety and in order not to void the warranty, service and repair of electro-medical equipment should be carried out only by the equipment manufacturer or by service personnel at authorized workshops. In case of any defects, make a detailed description of the defect(s) and contact your supplier. Do not use a defective device.

The manufacturer reserves the right to disclaim all responsibility for the operating safety, reliability and performance of equipment serviced or repaired by other parties. Following repair, the equipment should be tested by suitably qualified personnel.

The overall strategy

The strategy is to let the customers replace accessories themselves. More complicated repairs and replacements should be handled at a service setup either at the supplier or at the manufacturer.

Service is split into three categories:

• Customer self-service

This applies to accessories that can be replaced by the customer at the customer's location.

•

•

Service by supplier's technician

This applies to accessories and minor repair that can be performed by an authorized technician at either the customer's or the supplier's location.

Service by manufacturer technicians

This applies to accessories, and minor and major repair tasks that need to be performed at the manufacturer.

Service plans

This section lists references on how to replace the approved service parts which contain mechanical parts and a printed circuit board.

The overall service plan

The service plan covers the three main types of 1096 devices:

• MADSEN Zodiac PC-based (Quick Check and Diagnostic/Clinical)

• MADSEN Zodiac Stand-Alone Quick Check

• MADSEN Zodiac Stand-Alone Diagnostic/Clinical

The service plan also covers associated parts:

• Probes

• Contra phones

• Probe homes

• Cleaning kit

• Eartips

• Cavities

• Power supply


6 Service and repair

6.2

Service parts

Caution • Service and repair on any parts of the main unit and accessories must be performed only by authorized service technicians.

ESD precautions

Pay special attention to ESD during any service performed on an open instrument.

Note • MADSEN Zodiac contains parts that are sensitive to ESD (ElectroStatic Discharge). Any replacement should be performed in accordance with the existing ESD precautions.


7

7 Technical specifications

Technical specifications

Type identification

MADSEN Zodiac is type 1096 from GN Otometrics A/S

Compliance measuring system

Probe tone:

Dynamic probe tone level:

THD:

Frequency accuracy:

Range:

226 Hz at 85 dB SPL ± 3 dB


800 Hz at 70.5 dB SPL ± 3 dB


The probe tone level will be compensated to accommodate varying ear canal volumes.

The output level will be decreased in volumes < 1.7 ml

The output level will be increased in volumes > 2.3 ml

< 1% in 2 cc

± 0.5%

0.2 ml to 5.0 ml ± 5% or 0.05 ml whichever is greater *

5.0 ml to 8.0 ml ± 15% *

* The accuracy stated requires that calibration has been performed at the altitude where the device is to be put into operation

Acoustic reflex

Sensitivity

Reflex Threshold and Reflex Decay:

Reflex Screening:

Step size dB:

0.01, 0.02, 0.03, 0.04 or 0.05 mmho

0.04 mmho

Quick Check: 10 dB

Diagnostic: 5, 10 dB Clinical: 1, 2, 5, 10 dB

Contralateral Stimulation

Pure tones:

Frequency accuracy:

Range:

Range:

500 Hz, 1000 Hz, 2000 Hz, 4000 Hz

± 0.5%

BBN, LPN, HPN at 50 to 110 dB SPL * ±3 dB

* measured in the respective couplers

Contralateral insert phone:

500 Hz at 50 to 115 dB HL ± 3 dB

1000 Hz at 50 to 120 dB HL ± 3 dB

2000 Hz at 50 to 120 dB HL ± 3 dB

4000 Hz at 50 to 120 dB HL ± 3 dB

Contralateral TDH-39 phone:

500 Hz at 50 to 115 dB HL ± 3 dB

1000 Hz at 50 to 120 dB HL ± 3 dB

2000 Hz at 50 to 115 dB HL ± 3 dB

4000 Hz at 50 to 115 dB HL ± 3 dB



THD: < 5% for levels below 110 dB HL

< 10% for levels above 110 dB HL

< 2.5 % for levels below 110 dB HL

< 5 % for levels above 110 dB HL

Ipsilateral Stimulation

Tone:

Frequency accuracy:

Threshold range:

Screening range:

THD:

Range:

Screening range:

Step size dB:

Decay range:

500 Hz, 1000 Hz, 2000 Hz, 4000 Hz

± 0.5%

500 Hz at 50 to 105 dB HL ± 3 dB

1000 Hz at 50 to 110 dB HL ± 3 dB

2000 Hz at 50 to 110 dB HL ± 3 dB *

4000 Hz at 50 to 100 dB HL ± 3 dB

* For probe tones above 226 Hz, artifacts may start to occur at levels above

105 dB HL

500 Hz at 70 to 100 dB HL ± 3 dB

1000 Hz at 70 to 105 dB HL ± 3 dB

2000 Hz at 70 to 105 dB HL ± 3 dB *

4000 Hz at 70 to 105 dB HL ± 3 dB

* For probe tones above 226 Hz, artifacts may start to occur at levels above

105 dB HL

< 5% for levels below 110 dB HL

< 10% for levels above 110 dB HL

BBN, LPN, HPN at 50 to 110 dB SPL * ±3 dB (* measured in calibration coupler)

BBN at 50 to 90 dB SPL * ±3 dB (* measured in calibration coupler)

1, 2, 5, 10 dB

50 to 100 dB HL* (* artifacts may start to occur at levels above 95 dB HL in 0.5

cc)

Temporal characteristics

Initial/terminal latency:

Reflex Decay, Contralateral

Reflex Threshold and

Screening

0 ms

Rise/fall time: 250 ms

Ipsilateral Reflex Threshold and Screening

0 ms

[1]

250 ms

[1]

Overshoot/Undershoot: 0 % 0%

Contralateral stimulation -

Probe tone > 226 Hz

0 ms

100 ms

0%

Notes:

1. Tolerance +120/-0 ms



Characteristics for pulsed stimuli (ipsilateral)

Pulsed stimuli are used for ipsilateral Reflex Screening and Reflex Threshold testing.

Period:

Stimulus On time:

Stimulus Off time:

Rise/fall time:

120 ms

56 ms

64 ms

5.5 ms

On-Off ratio:

A weighted SPL in Off:

Stimulus presentation control

70 dB (for stimulus level > 95 dB HL)

Contra supra-aural TDH 39: 33 dB

Contra insert phone: 23 dB

Broadband noise

Contralateral TDH-39 headphone

Bandwidth:

Slope:

Level:

250 - 6000 Hz. Tolerance ±5 dB re. 1 kHz level.

Spectrum level drops between 6000 and 9500 Hz and remains below -23 dB re. 1 kHz level for frequencies above 9500 Hz.

Noise level is indicated in dB HL. Tolerance ±5 dB.

Contralateral insert earphone and ipsilateral probe

Bandwidth:

Slope:

400 - 4000 Hz. Tolerance ±5 dB re. 1 kHz level.

Spectrum level drops between 4000 and 7000 Hz and remains below -23 dB re. 1 kHz level for frequencies above 7000 Hz.

Level: Noise level is indicated in dB HL. Tolerance ±5 dB.

Lowpass noise


Band limit:

Slope:

Level:

1600 Hz (nominal -3 dB point)

The slope is between -12 and -18 dB/octave above 1600 Hz, with an additional

±6 dB tolerance. Above 8500 Hz, the spectrum level remains below -34 dB re.

1600 Hz level.

Noise level is indicated in dB HL. Tolerance ±5 dB.


Bandwidth:

Slope:


The slope is between -12 and -18 dB/octave above 1600 Hz, with an additional

±6 dB tolerance. Above 8500 Hz, the spectrum level remains below -34 dB re.

1600 Hz level.




Highpass noise


Band limit:

Slope:

Level:


The slope is between +12 and +18 dB/octave below 1600 Hz, with an additional ±6 dB tolerance.

Overall noise level is indicated in dB HL. Tolerance ±5 dB.


Bandwidth:

Slope:


The slope is between +12 and +18 dB/octave above 1600 Hz, with an additional ±6 dB tolerance.


ANSI & IEC reflex stimulus RETSPL values

Frequencies

(Hz)

Ipsilateral probe

HA-1

[2]

Insert phone

HA-1

[2]

Insert phone

HA-2

[2]

500

1000

2000

4000

BBN

[3]

LBN

[3]

HBN

[3]

6.5

7.5

4.0

6.0

0.0

2.5

0.0

6.0

9.5

5.0

6.0

0.0

2.5

0.0

8.0

8.5

7.5

5.5

0.0

3.0

5.5

7.0

9.0

9.5

12.0

10.5

12.5

Supra-aural phone

IEC 60318-

3/NBS 9A

[1]

11.5

Supra-aural phone

IEC 60318-1

[1]

13.5

7.5

9.0

12.0

13.5

11.5

14.5

Notes:

1. From ANSI/ASA S3.6-2010, Table 5.

2. From ANSI/ASA S3.6-2010, Table 7.

3. Based on Otometrics internal study

Air pressure system

Range:

Pressure sweep rate:

Normal +200 to -400 daPa/s. Extended +400 to -600 daPa/s

50, 100, 200, 400, 600 daPa/s ± 20% in 20% to 80% of the total pressure range



Pressure accuracy:

Pump measure direction:

Safety:

Graph units

Unit of admittance graph Y-axis:

Unit of graph X-axis:

Device display

Display:

Resolution:

USB port connector

Type:

± 10% or ± 10 daPa, whichever is greatest

For probe tones above 226 Hz and volumes below 0.7 cc, additional ± 10 daPa can occur.

Positive to negative or negative to positive

Separate safety +530 daPa and -730 daPa ±70 daPa ml, cc, mmho, µl daPa, sec

7 inch, 15:9 WVGA

800 x 480 pixel

USB device port

Power supply

External power supply

Output:

Input:

Power consumption

Power consumption:

XP Power, type AFM60US24

24 V, 2.5 A

100-240 V AC, 50-60 Hz, 1.5 A

< 70 VA

Operating environment

Temperature:

Air humidity:

Air pressure:

Warm-up time:

+15°C to +35°C (59°F to +95°F)

10 to 90%, non-condensing

600 hPa to 1060 hPa

< 10 min. If stored in conditions not within specified operating environment conditions, the device must warm up for 24 hour before being put into operation.

Altitude correction

The admittance of a cavity depends on the atmospheric pressure. This means that when the atmospheric pressure changes, the relation between mmho and ml changes. The following table can be used to calculate the difference.

Altitude (m) Increase in mmho (%)



28

0

500

1000

1500

2000

2500

3000

27

36

45

0

6

13

20

Storing and handling

Temperature:

Relative humidity:

Air pressure:

Dimensions (HxWxD)

Stand-alone version:

PC-based version:

Probe dimensions (HxWxD)

Quick Check probe:

Diagnostic probe:

-20°C to +60°C (-4°F to +140°F)

< 90 %, non-condensing

500 hPa to 1060 hPa

190 mm x 248 mm x 261 mm (7.5” x 9.8” x 10.3”)

100 mm x 240 mm x 240 mm (3.9” x 9.4” x 9.4”)

28 mm x 22 mm x 100 mm (1.1” x 0.9” x 3.9”)

10 mm x 10 mm x 25 mm (0.4” x 0.4” x 1.0”)

Weight

Stand-alone version:

PC-based version:

Optional features (Stand-alone)

Printer:

2 cc coupler

2.65 kg/5.85 lb

1.65 kg/3.64 lb

Built-in printer. Prints 832 dot line/s on 112 mm paper width

Calibration

Equipment should be calibrated regularly according to EN 60645-5 and ANSI S3.39

Essential performance

MADSEN Zodiac has no essential performance and accordingly, the applicable requirements are as stated in the following:

1. Impedance/admittance as defined by EN 61027 Type 1, ANSI S3.39 Type 1.

2. Basic safety as defined by IEC 60601-1.

All information required by IEC 60601-1-2:2007, #5.2.2.1-#5.2.2.10 is available in the MADSEN Zodiac User Guide.



Standards

Safety:

EMC:

Impedance/Admittance:

Power supply:

IEC 60601-1, UL 2601-1, CAN/CSA - C22.2 NO 601.1-90

ANSI/AAMI ES60601-1 + AMD 1, CAN/CSA-C22.2 No. 60601-1

MADSEN Zodiac: EN 60601-1, Class II, externally powered, Type BF, IPX0

EN 60601-1-2

Clinical/Diagnostic: EN 60645-5 Type 1, ANSI S3.39 Type 1

Quick Check: EN 60645-5 Type 2, ANSI S3.39 Type 2

Class I externally powered supply

Disposal

MADSEN Zodiac can be disposed of as normal electronic waste, according to WEEE and local regulations.


8 Accessories

8 Accessories

• Diagnostic probe, Classic

• Diagnostic probe, Comfort

• Quick Check probe

• Eartips

• Eartip box

• Otometrics insert phone, contralateral

• Contralateral phone, TDH-39

• Inserts for contralateral phones

• Shoulder strap hook

• Probe home for Quick Check probe, wall-mounted or device-mounted

• 2 cc cavity for probe check

• Multi-frequency cavity kit

• OTOsuite SW installation disk

• Power cord

• MADSEN Zodiac User Guide

• MADSEN Zodiac Reference Manual

• USB connection cable

• Power supply unit

• Paper roll for built-in printer

• Probe tips

• Wall-mount kit for PC-based device

• Probe cleaning kit


9

9 Notes on EMC (Electromagnetic Compatibility)

Notes on EMC (Electromagnetic Compatibility)

• MADSEN Zodiac is part of a medical electrical system and is thus subject to special safety precautions. For this reason, the installation and operating instructions provided in this document should be followed closely.

• Portable and mobile high-frequency communication devices, such as mobile phones, may interfere with the functioning of MADSEN Zodiac.

Guidance and manufacturer's declaration - electromagnetic emissions for all equipment and systems

MADSEN Zodiac is intended for use in the electromagnetic environment specified below. The user of MADSEN Zodiac should ensure that it is used in such an environment.

Emissions test Electromagnetic environment - guidance

RF emissions

CISPR 11

Compliance

Group 1 MADSEN Zodiac uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.

RF emissions

CISPR 11

Harmonic emissions IEC

61000-3-2

Class B

Not applicable

MADSEN Zodiac is suitable for use in all environments, including domestic environments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.

Voltage fluctuations/flicker emissions IEC 61000-3-3

Not applicable

Guidance and manufacturer's declaration - electromagnetic immunity for all equipment and systems


Immunity test IEC 60601 test level

Compliance level Electromagnetic environment - guidance

Electrostatic discharge (ESD)

IEC 61000-4-2

+/- 6 kV contact

+/- 8 kV air

+/- 6 kV contact

+/- 8 kV air

Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30 %.

Electrical fast transient/burst

IEC 61000-4-4

Surge IEC 61000-4-5

+/- 2 kV for power supply lines

+/- 1 kV for input/output lines

+/- 1 kV line(s) to line(s)

+/- 2 kV line(s) to earth

+/- 2 kV for power supply lines

+/- 1 kV for input/output lines

+/- 1 kV line(s) to line(s)

+/- 2 kV line(s) to earth

Mains power quality should be that of a typical commercial or hospital environment.

Mains power quality should be that of a typical commercial or hospital environment.

Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11

<5 % U

T

(>95 % dip in U

T

) for 0.5

cycle

40 % UT (60 % dip in U

T

) for 5 cycles

70 % U

T

(30 % dip in U

T

) for 25 cycles

<5 % U

T

(>95 % dip in U

T

) for 5 s

<5 % U

T

(>95 % dip in U

T

) for 0.5

cycle

40 % UT (60 % dip in U

T

) for 5 cycles

70 % U

T

(30 % dip in U

T

) for 25 cycles

<5 % U

T

(>95 % dip in U

T

) for 5 s

Mains power quality should be that of a typical commercial or hospital environment. If the user of the

MADSEN Zodiac requires continued operation during power mains interruptions, it is recommended that the

MADSEN Zodiac be powered from an uninterruptible power supply or a battery.



Power frequency

(50/60 Hz) magnetic field

IEC 61000-4-8

3 A/m

U

T is the AC mains voltage prior to application of the test level.

3 A/m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.

Guidance and manufacturer's declaration - electromagnetic immunity - for equipment and systems that are NOT life-supporting


Emissions test IEC 60601 test level

Compliance level Electromagnetic environment - guidance

Conducted RF

IEC 61000-4-6

3 Vrms

150 kHz to 80 MHz

3 Vrms

150 kHz to 80 MHz

Radiated RF

IEC 61000-4-3

3 V/m

80 MHz to 2.5 GHz

3 V/m

80 MHz to 2.5 GHz

Portable and mobile RF communications equipment should be used no closer to any part of MADSEN Zodiac, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.

Recommended separation distance: d = 1.2

d = 1.2

d = 2.3

for 80 MHz to 800 MHz for 80 MHz to 2.5 GHz, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in metres (m).

Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, a should be less than the compliance level in each frequency range.

b

Interference may occur in the vicinity of equipment marked with this symbol:

Note 1 : At 80 MHz and 800 MHz the separation distance for the higher frequency range applies.

Note 2 : These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

a. Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which MADSEN Zodiac is used exceeds the applicable RF compliance level above, the MADSEN Zodiac should be observed to verify normal operation. If abnormal performance is observed, additional measures might be necessary, such as reorienting or relocating MADSEN Zodiac.

b. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

Recommended separation distances between portable and mobile RF communications equipment and MADSEN Zodiac



The MADSEN Zodiac is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the

MADSEN Zodiac can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the MADSEN Zodiacas recommended below, according to the maximum output power of the communications equipment.

Rated maximum output power of transmitter

W

Separation distance according to frequency of transmitter m

150 kHz to 80 MHz d = 1.2

80 MHz to 800 MHz d = 1.2

800 MHz to 2.5 GHz d = 2.3

0.01

0.1

0.12

0.38

0.12

0.38

0.23

0.73

1

10

100

1.2

3.8

12

1.2

3.8

12

2.3

7.3

23

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.

Note 1 : At 80 MHz and 800 MHz the separation distance for the higher frequency range applies.

Note 2 : These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.




MADSEN Zodiac

Electronic equipment covered by the Directive 2002/96/EC on waste electrical and electronic equipment

(WEEE).

All electrical and electronic products, batteries, and accumulators must be taken to separate collection at the end of their working life. This requirement applies in the European Union. Do not dispose of these products as unsorted municipal waste.

You can return your device and accessories to Otometrics, or to any Otometrics supplier. You can also contact your local authorities for advice on disposal.

Consult user manual for warnings and cautions.

Consult user manual for warnings and cautions.

Complies with Type BF requirements of IEC60601-1.

Complies with Medical Devices Directive 93/42/EEC and RoHS Directive (2011/65/EC).

Complies with the Radio Equipment and Telecommunications Terminal Equipment Directive 1999/5/EC.

MEDICAL - General Medical Equipment as to electrical shock, fire and mechanical hazards only in accordance with UL 60601-1, first edition, 2003 CAN/CSA-22.2 No. 601.1-M90.

OR

MEDICAL - General Medical Equipment as to electrical shock, fire and mechanical hazards only in accordance with ANSI/AAMI ES60601-1 (2005) + AMD 1 (2012), IEC 60601-1-6, CAN/CSA-C22.2 No. 60601-1

(2014) and CAN/CSA-C22.2 No. 60601-1-6 (2011).

In France, it is only permitted to use the device indoors.

This device complies with part 15 of the FCC rules. Operation is subject to the following two conditions:

• This device must not cause harmful interference.

• This device must accept any interference received, including interference that may cause undesired operation.

The term”IC” before the certification/registration number signifies that the Industry Canada technical specifications were met.

OTOsuite Immittance module

Complies with Medical Devices Directive 93/42/EEC and RoHS Directive (2011/65/EC).

Used in error message dialogs if software program fails. See the detailed information in the dialog box.




This manual contains information and warnings, which must be followed to ensure the safe performance of the devices and software covered by this manual. Local government rules and regulations, if applicable, should also be followed at all times.

1. This class of equipment is allowed in domestic establishments when used under the jurisdiction of a health care professional.

2. MADSEN Zodiac is intended for diagnostic and clinical use by audiologists and other trained health care professionals in testing the hearing of their patients.

3. If you suspect infection in one ear, exchange the eartip and use a clean probe tip before you continue testing on the other ear.

4. To prevent cross-infection, use new eartips when you test the next client.

5. Accidental damage and incorrect handling can have a negative effect on the functionality of the device. Contact your supplier for advice.

6. For the sake of safety and in order not to void the warranty, service and repair of electro-medical equipment should be carried out only by the equipment manufacturer or by service personnel at authorized workshops. In case of any defects, make a detailed description of the defect(s) and contact your supplier. Do not use a defective device.

7. It is recommended to install the unit in an environment that minimizes the amount of static electricity. For example, anti-static carpeting is recommended.

8. We recommend that the device should not be stacked with other equipment or placed in a poorly ventilated space as this may affect the performance of the device. If it is stacked or placed adjacent to other equipment, make sure that the operation of the device is not affected.

9. Do not store or operate the device at temperatures and humidity exceeding those stated in the Technical Specifications, Transport and storage.

10. Keep the unit away from liquids. Do not allow moisture inside the unit. Moisture inside the unit can damage the instrument and it may result in a risk of electrical shock to the user or patient.

11. Do not use the instrument in the presence of flammable agents (gases) or in an oxygen-rich environment.

12. No parts may be eaten, burnt, or in any way used for purposes other than the applications defined in the Intended Use section of this manual.

13. Choking hazard! Do not leave eartips unsupervised within the reach of children.

14. The device and any device to be connected which has its own power supply should be turned off before any connections are established.

To disconnect the device from the mains supply, pull the mains plug out of the wall mains outlet. Do not position the unit so that it is difficult to pull the mains plug out of the wall mains.

15. For safety reasons and due to effects on EMC, accessories connected to the equipment's outlet fittings must be identical to the type supplied with the system.

16. It is recommended that an annual calibration be performed on accessories containing transducers. Furthermore, it is recommended that calibration be performed if the equipment has suffered any potential damage (e.g. headphones, contraphones, probes dropped on the floor).

Note that calibration has been performed only on the transducers supplied! If you wish to use any other transducer for testing with the device, please contact your local distributor first.

17. Disposable accessories, such as eartips, should not be reused and must be replaced between patients to prevent crossinfection.



18. Unwanted noise may occur if the instrument is exposed to a strong radio field. Such noise may interfere with the process of recording correct measurements. Many types of electrical devices, e.g. mobile telephones, may generate radio fields. We recommend that the use of such devices in the vicinity of this instrument be restricted as much as possible.

Likewise, we recommend that the instrument is not used in the vicinity of devices sensitive to electromagnetic fields.

19. Changes or modifications not expressly approved by the manufacturer could void the user's authority to operate the equipment.

20. The device and power supply can be disposed of as normal electronic waste, according to local regulations.

21. Use only the specified power supply.

See Technical Specifications, Power supply.

When assembling an electro-medical system, the person carrying out the assembly must take into account that other connected equipment which does not comply with the same safety requirements as this product

(e.g. PC and/or printer) may lead to a reduction in the overall safety level of the system. The equipment must comply with UL/IEC 60950.

When selecting accessories connected to the device, the following points must be considered:

• Use of connected equipment in a patient environment.

• Proof that connected equipment has been tested in accordance with IEC 60601-1 (3rd), AAMI ES60601-1 and CAN/CSA-C22.2 NO. 60601-1-08-CAN/CSA.

Do not touch the output DC plug of the power supply or connectors of the device or connected devices and the patient at the same time.

22. To comply with IEC 60601-1(3rd) computer and printer must be placed out of reach of the client, i.e. not closer than approx. 1.5 meters/5 ft.

23. This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures:

– Increase the separation between the equipment and receiver.

– Connect the equipment into an outlet on a circuit different from that to which the receiver is connected.

– Consult the dealer or an experienced radio/TV technician for help.


12 Manufacturer

12 Manufacturer

GN Otometrics A/S

Hoerskaetten 9, 2630 Taastrup

Denmark

( +45 45 75 55 55

7 +45 45 75 55 59 www.otometrics.com

12.1

Responsibility of the manufacturer

The manufacturer is to be considered responsible for effects on safety, reliability, and performance of the equipment only if:

• All assembly operations, extensions, re-adjustments, modifications or repairs are carried out by the equipment manufacturer or personnel authorized by the manufacturer.

• The electrical installation to which the equipment is connected complies with EN/IEC requirements.

• The equipment is used in accordance with the instructions for use.

The manufacturer reserves the right to disclaim all responsibility for the operating safety, reliability and performance of equipment serviced or repaired by other parties.


Index

Index

A

Annual calibration 16

C

Calibration 11

accessing calibration menu 15

annual 16

calibration certificate 19

levels 18

pressure 17

probe admittance 19

probe contra stimulus 18 probe ipsi stimulus 18

SLM microphone corrections 19

tools 12

transducer information 16

Calibration certificate 19

E

ESD precautions 22

F

Firmware update, test devices (Imm.) 20

L

Levels

calibration 18

P

Pressure

calibration 17

Printer

troubleshooting 9

Probe

admittance calibration 19

calibration 18 calibration contra stimulus 18

calibration information 16

calibration ipsi stimulus 18

SLM microphone corrections 19


S

Service

ESD precautions 22

System description 7, 10

T

Test devices (Immittance)

firmware update 20

Transducers

calibration information 16

Troubleshooting

printer 9

Index


Index


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