User Guide
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MADSEN Itera II User Guide Doc. No. 7-50-1520-EN/02 Part No. 7-50-15200-EN
Copyrightnotice No part of this documentation orprogram may be reproduced, stored in a retrieval system, ortransmitted, in any form orby any means, electronic, mechanical, photocopying, recording,or otherwise,without the prior written consent of GN Otometrics A/S. Copyright© 2015, GN Otometrics A/S Published in Denmark byGN Otometrics A/S, Denmark All information, illustrations, and specifications in this manual are based on the latest productinformation available at the time of publication. GN Otometrics A/Sreserves the right to make changes at any time without notice. Registered trademarks and Trademarks MADSEN Itera II,MADSEN OTOflex 100, OTOsuite,AURICAL FreeFit, AURICAL Visible Speech, MADSEN Astera², MADSEN Xeta, ICS Chartr 200 VNG/ENG, ICS Chartr EP, OTOcam 300, MADSEN AccuScreen, MADSEN AccuLink,ICS AirCal, AURICAL Aud, AURICAL HIT, ICS Impulse, OTObase and MADSEN Capella² are either registered trademarks ortrademarks of GN Otometrics A/S. Versionrelease date 2015-09-30 (117479) Technicalsupport Please contact your supplier.
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Table of Contents 1
Device description
4
2
Intended use
4
3
Unpacking
5
4
Installation
5
5
Powering the device
6
6
Connecting MADSEN Itera II to OTOsuite
7
7
Connecting accessories to MADSEN Itera II
7
8
Toolbar icons in the Audiometry Module
9
9
Proper transducer placement
11
10 Performing tone audiometry
11
11 Performing speech audiometry
12
12 Service, cleaning and calibration
13
13 Other references
15
14 Technical specifications
15
15 Definition of symbols
22
16 Warning notes
23
17 Manufacturer
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1 Device description
1
Device description MADSEN Itera II is an audiometer for testing a person's hearing. With MADSEN Itera II you can perform all standard audiometric tests, tone and speech audiometry and special tests. Depending on the configuration, various special tests such as SISI, Stenger, ABLB (Fowler), and HIS are available. •
MADSEN Itera II can be used in connection with the OTOsuite Audiometry Module software for online monitoring of test results, data export and storage, printing, and NOAH compatibility. Test intensities and frequencies as well as the current test settings and other information are shown on the PC monitor.
•
MADSEN Itera II can be used as a portable instrument or as a desktop unit (fixed installation).
Operation The front panel buttons have indicator lights, which clearly show the device's current settings. Sound level, frequency and other information are shown clearly on the device display.
Transferring data to OTOsuite The test results are stored in the device and the results can be transferred to the OTOsuite PC software.
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Intended use MADSEN Itera II and the Audiometry module Users: audiologists, ENTs and other health care professionals in testing the hearing of their patients. Use: diagnostic and clinical audiometric testing.
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 precautionary statements as follows:
Warning • Indicates that there is a risk of death or serious injury to the user or patient.
Caution • Indicates that there is a risk of injury to the user or patient or risk of damage to data or the device.
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3 Unpacking
Note • Indicates that you should take special notice.
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 during 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. Check the Test Report (Calibration Certificate), make sure that the transducers (headphones and bone oscillator) are the correct ones, and that they comply with the ordered calibration standards.
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Installation Install OTOsuite on the PC before you connect to MADSEN Itera II from the PC. For instructions on installing OTOsuite, see the OTOsuite Installation Guide, which you can find on the OTOsuite installation medium (disk or memory stick). MADSEN Itera II is fully assembled on delivery, and you simply have to connect cables.
Caution • To connect MADSEN Itera II to the PC, use the supplied USB cable. The cable length must not exceed 3 m (approx. 10 feet).
Installation sequence 1. Install OTOsuite on your PC. 2. Assemble and set up MADSEN Itera II. –
See Powering the device ► 6
3. Switch on MADSEN Itera II. 4. Run the Configuration Wizard in OTOsuite to connect to and set up communication with MADSEN Itera II. –
See Connecting MADSEN Itera II to OTOsuite ► 7.
Connection panel - MADSEN Itera II For a detailed description of the connection panel, see the MADSEN Itera II Reference Manual. The connections are located at the back of MADSEN Itera II. All four cables for connecting accessories are joined in a bundle and color-coded for easy connection:
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5 Powering the device
•
Yellow: Operator desktop microphone
•
Green: Operator monitor headset, headphones
•
Pink: Operator monitor headset, boom microphone
•
Gray: Operator monitor speaker
A. B. C. D.
SF (AC), right and left AC BC CD/Tape
External microphone/Monitor headset F. Monitor G. Talk back E.
H. I. J. K.
Digital aux. Patient response DC power out RS232 interface
Caution • When you connect other electrical equipment to MADSEN Itera II, remember that equipment that does not comply with the same safety standards as MADSEN Itera II can lead to a general reduction in the system's safety level.
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Powering the device 1. Plug the power cord into the power socket of MADSEN Itera II. See Installation ► 5. 2. Plug the other end of the power cord directly into an AC mains power outlet with a three-wire protective ground.
Switching MADSEN Itera II on and off A. The on/off switch is located on the right side of MADSEN Itera II.
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6 Connecting MADSEN Itera II to OTOsuite
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Connecting MADSEN Itera II to OTOsuite Launching OTOsuite When you use MADSEN Itera II for the first time, run the Configuration Wizard to set up the connection between MADSEN Itera II and OTOsuite. After you have configured OTOsuite for the first time, if MADSEN Itera II is turned on when you open the Control Panel in OTOsuite, then MADSEN Itera II will connect to OTOsuite automatically. Otherwise, you can connect MADSEN Itera II 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.
Connecting to OTOsuite •
Run the OTOsuite Configuration Wizard to connect to and set up communication with MADSEN Itera II: Select Tools >
Configuration Wizard... Click the Configure button next to Audiometry and connect to the device as described in the OTOsuite User Guide.
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Connecting accessories to MADSEN Itera II 1. When selecting accessories connected to the RS232 socket and DC output of 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 Medical Electrical Systems in IEC 60601-1 3.1 edition: 2012, ANSI/AAMI ES60601-1 (2005) + AMD 1 (2012) and CAN/CSA-C22.2 No. 60601-1 (2014).
See General warning notes ► 23. See also Installation ► 5. For a detailed description of the connection panel, see the MADSEN Itera II Reference Manual.
7.1
Air conduction See Installation ► 5 for an overview of the connection panel.
Headphones •
Connect the right and left cables (red and blue) from the transducers to the right and left AC sockets in the rear panel of MADSEN Itera II.
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7 Connecting accessories to MADSEN Itera II
Insert phones •
Connect the Insert phones to the right and left AC socket in the rear panel of MADSEN Itera II. They must be connected according to calibration.
Alternatively, connect them to the right and left SF socket. •
7.2
To verify the calibration, press [AC]/[SF] and the display will show the transducer calibrated for that output.
Bone conduction See Installation ► 5 for an overview of the connection panel. •
7.3
Connect the bone conduction transducer plug into the BC socket located in the rear panel of MADSEN Itera II.
External microphone See Installation ► 5 for an overview of the connection panel. In speech testing and patient communication there are two possible external microphone solutions: •
Gooseneck, or
•
Boom microphone on the monitor headset.
Connect the chosen microphone solution to the “EXTERNAL MIC/MONITOR HEADSET” socket. Connecting one of these disables the internal talk-over microphone.
Gooseneck
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8 Toolbar icons in the Audiometry Module
Monitor headset with boom microphone
7.4
Free Field See Installation ► 5 for an overview of the connection panel.
Without Power Amplifier •
Plug the Free Field transducer cables directly into the R-SF and L-SF sockets located in the rear panel of MADSEN Itera II. The sound is then routed out through sound field speakers.
•
With Power Amplifier •
Plug the Power Amplifier cables into the two center sockets in the rear panel of MADSEN Itera II.
A. Free Field cables
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B.
Power Amplifier cables
Toolbar icons in the Audiometry Module The icons available in the toolbar depend on the test function that you have selected.
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8 Toolbar icons in the Audiometry Module
Audiometry icons Tone audiometry
Speech audiometry
Menu item
Combined Audiogram
Icon
Description Click to toggle between viewing both ears in a single audiogram (combined audiogram) or both a left and a right audiogram on your screen.
Combined View •
Click to view both ears in a single audiogram.
Split View •
Masking Assistant
Click to view separate audiograms for each ear.
Enable or disable the Masking Assistant. The Masking Assistant causes an unmasked threshold to flash repeatedly if masking is recommended.
Standard / All / High frequencies
The graph shows up to 20,000 Hz. MADSEN Itera II presents stimulus up to 12,500 Hz. •
Click to choose between viewing:
Standard Frequencies Displays the audiogram from 125 to 8000 Hz.
All Frequencies Displays the audiogram from 125 to 20,000 Hz.
High Frequencies Displays the audiogram from 8000 to 20,000 Hz.
New Audiogram
Select new audiogram. You will be prompted to save or cancel current data.
Select Orientation
Click to select the perspective of the patient's ears as presented on the screen for graph and table views. You can also select the location of the stimulus control.
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9 Proper transducer placement
9
Proper transducer placement Headphones 1. Loosen the headband and place both the left and right side of the headphones simultaneously.
Note • If the headphones are not placed properly, there is risk of causing the ear canal to collapse which will result in elevated thresholds.
2. Aim the center of the headphones towards the patient's ear canals and gently place them against the ears. 3. Tighten the headband while holding the headphones in place with your thumbs. 4. Examine the placement of the headphones to make sure they are level, and properly positioned.
Insert Earphones Young children tolerate insert earphones better than headphones. 1. Select the largest foam eartip that will fit into the patient's ear. If the eartip is too small the sound will leak out and the dB level will not be accurate at the eardrum. Insert earphones have greater attenuation between ears especially at the low frequencies; this reduces the need for masking. 2. It is best to clip the insert earphone transducers behind the child or on the back of their clothing and then fit the foam eartip into the child's ears.
Bone Oscillator
Note • For unmasked bone thresholds, you can store binaural data by selecting Binaural bone in the routing section of the control panel.
Mastoid placement 1. Move any hair covering the mastoid out of the way and place the flat round part of the bone oscillator securely on the boniest portion of the mastoid without any part of the transducer touching the external ear. 2. Make sure the bone oscillator is tight on the mastoid but still comfortable. 3. If you are going to perform masking with earphones, position the other end of the bone oscillator headband over the patient's temple on the opposite side of the head so that the headband of the earphones and bone oscillator fit on the patient's head.
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Performing tone audiometry For detailed examples of audiometric testing, see the MADSEN Itera II Reference Manual. During online testing, the screen reflects the test done by the audiometer as it progresses.
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11 Performing speech audiometry
A. Stimulus bar B. Work area C. Legend box
1. If needed, select TONE on MADSEN Itera II. 2. Prepare the patient. If you wish to instruct the patient after you have placed the transducers on the head of the patient, you can use the TALK OVER button. You can talk to the patient to adjust the patient communication levels when TALK OVER is active. 3. Select test conditions for ear, transducer, unmasked/masked, and test type on MADSEN Itera II. 4. Select the test frequency with the FREQUENCY knob. 5. Select the stimulus level with the LEVEL knobs. 6. Present the tone with the stimulus presentation button INT.. 7. Use the STORE button to store the data point and proceed to the next frequency. 8. Repeat steps 4 to 8 until all the measurements you need have been completed. If needed, did you test: –
Both ears
–
Air conduction
–
Bone conduction
–
Masking
–
Threshold, MCL and UCL
9. Save the audiogram.
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Performing speech audiometry For detailed examples of audiometric testing, see the MADSEN Itera II Reference Manual.
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12 Service, cleaning and calibration
A. Stimulus bar B. Work area, tabular view C. Audiogram
During online testing, the screen reflects the test done by the audiometer as it progresses. 1. Select SPEECH on MADSEN Itera II. 2. If needed, click the Scoring and Playing icon to set up word or phoneme scoring.
3. Prepare the patient. If you wish to instruct the patient after you have placed the transducers on the head of the patient, you can use the TALK OVER button. You can talk to the patient to adjust the patient communication levels when TALK OVER is active. 4. Select test conditions for ear, transducer, unmasked/masked, and test type on MADSEN Itera II. 5. Select the stimulus level with the LEVEL knobs. 6. Select speech input signals: Press the MIC. or CD button on MADSEN Itera II for either microphone input or pre-recorded input sources. 7. Use the PASS and FAIL buttons on MADSEN Itera II to score words. 8. Store the current data as the result by pressing STORE on MADSEN Itera II. 9. Repeat until all the measurements you need have been completed.
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Service, cleaning and calibration Warning • Under no circumstances disassemble MADSEN Itera II. Contact your supplier. Parts inside MADSEN Itera II must only be checked or serviced by authorized personnel.
Otometrics - MADSEN Itera II
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12 Service, cleaning and calibration
12.1
Service 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.
12.2
Cleaning The device •
Remove dust using a soft brush.
•
Use a soft, slightly damp cloth with a small amount of mild detergent or approved non-caustic medical grade disinfectant wipes to clean the unit according to local infection control regulations. 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.
Accessories These parts are in constant contact with your patients and should therefore be kept clean. •
Headphones Use a non-alcohol based wipe (e.g. Audiowipe) to clean the headphones between patients.
•
Eartips for Insert Earphones The eartips are disposable and therefore should not be cleaned or re-used.
•
Bone oscillator Clean the bone oscillator between patients, e.g. with a non-alcohol based antibacterial wipe, such as Audiowipes.
Disposal There are no special requirements for the disposal of eartips, i.e. they can be discarded according to local regulations.
12.3
Calibration Annual calibration The audiometer, headphones, bone oscillators, and sound field speakers must be calibrated once a year by your authorized service department.
Caution • 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.
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13 Other references
13
Other references For more information, see the online Help in OTOsuite, which contains detailed reference information about MADSEN Itera II and the OTOsuite modules. For instructions on installing OTOsuite, see the OTOsuite Installation Guide, which you can find on the OTOsuite installation medium (disk or memory stick).
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Technical specifications
14.1
MADSEN Itera II Type identification MADSEN Itera II is type 1004 from GN Otometrics A/S.
Channels 2 separate and identical channels
Pure tone frequencies AC and SF:
12 standard 125 - 8000 and 12500 Hz
BC:
250 - 8000 Hz standard frequencies
Insert phones
125 - 6000 Hz standard frequencies
Accuracy:
Better than 1 %.
Modulation FM (Warble):
1 - 20 Hz in 1 Hz steps. Mod. width 1% - 25% in 1% steps
AM for SISI:
5, 4, 3, 1, 0.75, 0.50, 0.25 dB HL steps
Attenuator 1 dB HL / 2.5 dB HL / 5 dB HL step resolution over the entire range
Attenuator accuracy In whole range:
better than 3 dB HL
Between two consecutive attenuator positions: 5 dB HL step:
better than 1 dB HL
2.5 dB HL step:
better than 0.75 dB HL
1 dB HL step:
better than 0.3 dB HL
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14 Technical specifications
HL Range Maximum output will be limited by the transducer. AC:
-10 to 120 dB HL at mid-frequencies
BC:
-10 to 70 dB HL at mid-frequencies
HIS function Low pass frequencies:
250 Hz, 500 Hz, 1 kHz or 2 kHz
High pass frequencies:
1 kHz, 2 kHz, 3 kHz or 4 kHz
Amplification options:
0, 5, 10, 15, 20, 25 dB SPL
Max. output:
130 dB SPL (for TDH39)
Max. gain:
50 dB SPL
Masking Narrow band noise, Speech noise and White noise (Wide band noise)
Total harmonic distortion Air < 2.5 % Bone < 5 %
Selectable transducers AC:
TDH39, ME-70, and Otometrics insert phones
BC:
NB-71, B-71 (Mastoid / Forehead)
SF:
TDH39, ME-70, Otometrics insert phones , Free-Field amplifier/loudspeaker
Transducer options depend on how MADSEN Itera II is calibrated.
Outputs AC:
2 x mono jack, 1/4 "
BC:
1 x mono jack, 1/4 "
SF:
2 x mono jack, 1/4 "
External inputs CD/Tape:
0.2 to 2.0 Vrms, 10 k 2 x RCA phone
Microphone:
0.002 to 0.02 Vrms, 2 x 8-pole DIN
Talk Back:
0.002 to 0.02 Vrms, 5-pole DIN for all microphones
DC bias for electric Mic. Optional input resistance between: 10 k and 600Ω.
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14 Technical specifications
Interrupter Normal:
The signal is presented when the INT button is pressed.
Reverse:
The signal ceases when the INT button is pressed.
Pulse:
The signal is pulsed The pulse frequency can be adjusted in the range 0.25 to 2.5 Hz in 0.25 Hz steps.
Impulse:
The signal is presented for a preset period of time: 0.25 to 2.5 sec., in steps of 0.25 sec.
Operator output Two stereo monitor sockets (8-pole DIN horseshoe) for headphones. One socket is fitted with a Talk Over Mic. Input option. The monitor signal follows the test signal, although the volume can be adjusted individually for each channel. The Talk Back signal from patient to operator is mixed with the monitor signal.
Static force of transducer headbands TDH 39:
4.5 N ± 0.5 N
B-71:
5.4 N ± 0.5 N
RS232 interface Format:
8 data bit, 1 stop bit
Parity:
Equal
Baud rate:
9600, 19200, 38400, 57600 Baud
Protocol:
XON/XOFF
Transport and storage Temperature:
-40°C to + 70°C (-40°F to + 158°F)
Air humidity:
10% to 90%, non-condensing
Air pressure
500 hPa to 1060 hPa
Operating environment Mode of operation:
Continuous
Temperature:
+10°C to +35°C (50°F to +95°F)
Air humidity:
30% to 90%, non-condensing
Air pressure
860 hPa to 1060 hPa.
(Operation in temperatures exceeding -20°C (-4°F) or +60°C (140°F) may cause permanent damage.)
Warm-up time < 10 min.
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14 Technical specifications
Disposal MADSEN Itera II can be disposed of as normal electronic waste, according to WEEE and local regulations.
Dimensions Approx. 450 x 290 x 85 mm, 17.7 x 11.4 x 3.3 inches
Weight Approx. 4.5 kg, 9.9 lb.
Power supply Internal, 100 - 120 V AC, 200 - 240 V AC, 50/60 Hz
Power consumption < 60 VA
Fuses T 1 A H/250 V
Standards Audiometer:
EN60645-1, EN60645-2, EN60645-4, and ANSI S3.6
Patient Safety:
Complies with IEC 60601-1 3.1 edition:2012, Class I, Type B; IEC 60601-1-6:2010; IEC 62366:2007; CAN/CSA-C22.2 NO 60601-1:2014; ANSI/AAMI ES60601-1 (2005) + AMD 1 (2012)
EMC:
IEC 60601-1-2:2007
Miscellaneous Internal power supply to CD player: 1.5 - 10 V, 0.5 V steps Software-adjustable contrast/brightness on display and LEDs Integral Talk Over microphone Digital Aux: 5-pole DIN
14.2
Accessories Standard accessories and optional accessories may vary from country to country - please consult your local distributor.
18
•
TDH 39 headphones
•
ME-70 headphones
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14 Technical specifications
14.3
•
Otometrics insert phones
•
Bone oscillators: NB-71, B-71
•
Sound field loudspeakers
•
Monitor headphones with boom microphone
•
Gooseneck talk-over microphones (one right and one left microphone) for speech audiometry and Hearing Instrument Simulation
•
Talkback microphone
•
Patient Responder(s)
•
Mains cable
•
Power supply cable from MADSEN Itera II to CD player
•
PA 210 power amplifier for free-field testing
•
Wall mount kit for amplifier
•
Connection cables
•
Audiogram pad
•
MADSEN Itera II Reference Manual
•
MADSEN Itera II User Guide
Notes on EMC (Electromagnetic Compatibility •
MADSEN Itera II 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 Itera II. Guidanceand manufacturer's declaration - electromagnetic emissions for all equipment and systems MADSEN Itera II is intended for use in the electromagnetic environment specified below. The user of MADSEN Itera II should ensure that it is used in such an environment. Emissionstest
Compliance
Electromagnetic environment - guidance
RF emissions
Group 1
MADSEN Itera II uses RF energy only for its internal function. There-
CISPR 11
fore, its RF emissionsare very low and are not likely to cause any interference in nearby electronic equipment.
RF emissions CISPR 11
Class A
MADSEN Itera II is suitable for use in all establishments other than domestic and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.
Note: The emissions characteristics of this equipment make it suitable for use in industrial areas and hospitals(CISPR 11class A). If it is used in aresidential environment (for which CISPR 11 class B isnormally required) this equipment might not offer adequate protection to radio-frequency communication services. The user might need to take mitigation measures, such asrelocating or re-orienting the equipment.
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14 Technical specifications
Guidanceand manufacturer's declaration - electromagnetic immunity for all equipment and systems MADSEN Itera II is intended for use in the electromagnetic environment specified below. The user of MADSEN Itera II should ensure that it is used in such an environment. Immunitytest
IEC 60601
Compliancelevel
Electromagnetic environment - guidance
+/- 6 kV contact
+/- 6 kV contact
Floors should bewood, concrete or ceramic tile. If floors are covered with syn-
+/- 8 kV air
+/- 8 kV air
thetic material, the relative humidity should be at least 30%.
3A/m
3A/m
Power frequency magnetic fields should be at levels characteristic of a typical loc-
test level
Electrostatic discharge (ESD) IEC 61000-4-2 Power frequency (50/60 Hz) magnetic
ation in a typical commercial or hospital environment.
field IEC 61000-4-8 UT is the AC mains voltage prior to application of the test level.
Guidanceand manufacturer's declaration - electromagnetic immunity - for equipment and systems that are NOT life-supporting MADSEN Itera II is intended for use in the electromagnetic environment specified below. The user of MADSEN Itera II should ensure that it is used in such an environment. Immunitytest
IEC 60601
Compliancelevel
Electromagnetic environment - guidance
3V/m
Portableand mobile RF communications equip-
test level Radiated RF IEC 61000-4-3
150 kHzto 80 MHzoutside ISM
ment should be used no closer to any part of
bands a
MADSEN Itera II, including cables, than the recom-
3V/m 80MHz to 2.5 GHz
mended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance: d = 1.2 d = 1.2
for 80MHz to 800 MHz
d = 2.3
for 80MHz 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 strengthsfrom fixed RF transmitters, as determined by an electromagnetic site survey, a should beless than the compliance level in each frequency range. b Interference may occur in the vicinity of equipment marked with this symbol:
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