Instructions for Use
97 Pages
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Instructions for Use Titan
8100759 - ver. 04/2013
Table of contents 1. Introduction……………………………………………………………………...……….1 1.1 1.2 1.3 1.4
About this Manual ... 1 Intended Use ... 1 Product Description ... 1 Warnings ... 4
2. Unpacking & Installation………..……………..……………………………...……….5 2.1 2.2 2.3 2.4 2.5 2.6 2.7 2.8 2.9 2.10 2.11
Unpaking and Inspection ... 5 Marking ... 6 Hardware installation ... 7 Installing the cradle ... 8 Mounting a Cradle on the wall ... 10 Cradle Indication Lights ... 11 Calibration Cavities and Issues ... 11 Installing the Thermal Printer ... 12 Installing Paper in the Thermal Printer ... 12 Installing Bluetooth for direct printing with HP Officejet 100 Mobile Printer or a thermal printer ... 13 Installing Titan and its battery ... 13 2.11.1 2.11.2
2.12 2.13 2.14 2.15 2.16 2.17 2.18 2.19 2.20 2.21 2.22 2.23 2.24 2.25
Charging the Battery ... 14 Battery Lifetime and Charging Time ... 14
Changing Probes and Extension Cords on the Titan ... 15 Connecting transducers to the shoulder box and PreAmp ... 16 Placing and using the Shoulder Box or PreAmplifier ... 16 Placing the Montage-Indication Stickers on the PreAmplifier... 17 Use of the EARTone ABR Transducer with Ear tips, Foam Inserts or EarCups (ABRIS440 only) ... 18 Safety Precautions to take when connecting the Titan. ... 19 Software Installation ... 25 Installation of the Driver ... 27 Installation of NOAH Toolbar shortcut ... 28 Standalone Installation of Titan Suite ... 29 License... 29 Creating a Bluetooth connection for PC controlled measurements ... 29 Bluetooth Installation Quick Guide (Win 7) ... 29 Bluetooth Installation Quick Guide (Win XP) ... 31
3. Operating Instruction ……………………………………………………...………….35 3.1 3.2 3.3 3.4 3.5
Handling and selection of ear tips ... 36 Switching the Titan on and off ... 36 Probe Status ... 36 Titan Handheld Operation Panel ... 37 Operating Titan in Handheld Mode ... 37 3.5.1 3.5.2 3.5.3 3.5.4 3.5.5 3.5.6 3.5.7 3.5.8 3.5.9 3.5.10 3.5.11 3.5.12
Startup ... 37 Battery ... 37 Test Screen... 37 Done Screen ... 40 Select Client & Save ... 41 Edit New Screen ... 41 View Clients Screen ... 41 View Details Screen ... 42 Edit Details Screen ... 42 View Sessions Screen ... 42 View Session Screen ... 43 Select Protocol Screen ... 43
3.5.13 3.5.14 3.5.15 3.5.16 3.5.17 3.5.18 3.5.19 3.5.20
3.6
Operating in PC Controlled Mode ... 47 3.6.1 3.6.2
3.7 3.8 3.9 3.10 3.11 3.13 3.14 3.15
Setup Screen ... 44 Language Screen... 44 Date & Time Screen... 44 Titan Screen... 45 Printer Screen ... 45 Clinic Info Screen ... 45 License Screen ... 45 About Screen ... 46 Starting from OtoAccess™ ... 47 Starting from Noah ... 47
PC Controlled Operation via Bluetooth ... 48 Using the Main Tab... 49 Using the IMP module ... 54 Using the 3D Tympanometry and Absorbance test ... 59 Using the ABRIS module ... 63 Using the DPOAE module ... 67 Using the TEOAE tab ... 73 Using the Print Wizard ... 79
4. Maintenance…………………………………………………………………...…….….81 4.1 4.2 4.3 4.4 4.5
General Maintenance Procedures ... 81 How to clean Interacoustics Products ... 81 Cleaning the Probe Tip ... 82 Concerning Repair ... 83 Warranty ... 84
5. Technical Specifications …………………………………………………...…….….85
Titan Instruction for Use - GB
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1 Introduction 1.1 About this Manual This manual is valid for the Titan version 3.0. These products are manufactured by: Interacoustics A/S Drejervænget 8 DK 5610 Assens Denmark Tel.: +45 6371 3555 Fax: +45 6371 3522 E-mail: [email protected] Web: www.interacoustics.com
1.2 Intended Use The Titan with IMP440 Impedance System is an electroacoustic test instrument that produces controlled levels of test tones and signals intended for use in conduction diagnostic hearing evaluations and assisting in the diagnosis of possible otologic disorders, It features tympanometry and acoustics reflex. It also measures various acoustic properties of the ear, namely power reflectance, power absorption, transmittance, reflectance group delay, complex acoustic impedance and admittance, and equivalent ear canal volume. These measures allow the evaluation of the functional condition of the middle and outer ear. The target population for Titan with IMP440 includes all ages. The Titan with DPOAE440 is intended for use in the audiologic evaluation and documentation of ear disorders using Distortion Product Otoacoustic Emissions. The target population for Titan with DPOAE440 includes all ages. The Titan with ABRIS440 is intended for use in the audiologic evaluation and documentation of ear and nerve disorders using auditory evoked potentials from the inner ear, the auditory nerve and the brainstem. The target population for Titan with ABRIS440 is newborns. The Titan with TEOAE440 is intended for use in the audiological evaluation and documentation of ear disorders using Transient Evoked Otoacoustic Emissions. The target population for Titan with TEOAE440 includes all ages. The Titan System is to be used by trained personnel only such as audiologists, ENT surgeons, doctors, hearing healthcare professionals or personnel with a similar level of education. The device should not be used without the necessary knowledge and training to understand its use and how results should be interpreted.
1.3 Product Description The Titan is a multifunctional screening and/or diagnostic device that interfaces with integrated audiologic software modules on a PC or can be operated as a standalone handheld device. Depending on the installed software modules, it can perform:
Impedance and Wide Band Tympanometry (IMP440) Distortion Product Otoacoustic Emissions (DPOAE440) Automated Auditory Brainstem Responses (ABRIS440) Transient Evoked Otoacoustic Emissions (TEOAE440)
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The system consists of the following included and options parts: IMP440 Included parts: Titan handheld unit with basic probe Power supply (with converter) BET55 Ear tips and box Lithium Battery 4 cavities (0.2, 0.5, 2 and 5cc) Titan PC suite with IMP440 Instructions for Use TCB Carrying Bag Included parts with diagnostic & clinical versions: Cradle Clinical probe extension CIR55 contra insert headset OtoAccess™ database
Optional parts: Short probe extension Thermal printer AB1310/AB1310 Bluetooth DD45C contra cup headset EARtone 3A insert headset for contra Cradle Clinical probe extension OtoAccess™ database WBT calibration kit
DPOAE440 Included parts: Titan handheld unit with basic probe Cradle Power supply (with converter) Clinical probe extension BET55 Ear tips and box Lithium Battery 4 cavities (0.2, 0.5, 2 and 5cc) Titan PC suite with DPOAE440 OtoAccess™ database USB cable, USB adaptor Instructions for Use TCB Carrying Bag Included parts with screener version: Eartip 3-5mm flanged (25 pcs.) Eartip 4-7mm flanged (25 pcs.) Eartip 5-8mm flanged (25 pcs.)
Optional parts: Short probe extension Thermal printer AB1310/AB1310 Bluetooth
ABRIS440 Included parts: Titan handheld unit with basic probe Cradle Power supply (with converter) PreAmplifier w/clothing clip & neckstrap Montage stickers Short extension cable ETSE tab surface electrode cables Pinch style electrode cables Sanibel tab surface electrodes (36 pcs.) Sanibel snap surface electrodes (36 pcs.) SPG15 preparation gel Alcohol pads, Gauze swabs USB cable, USB adaptor BET55 Ear tips and box Eartip 3-5mm flanged (25 pcs.) Eartip 4-7mm flanged (25 pcs.) Eartip 5-8mm flanged (25 pcs.) Lithium Battery 4 cavities (0.2, 0.5, 2 and 5cc) Titan PC suite with ABRIS440 OtoAccess™ database Instructions for Use TCB Carrying Bag Optional parts: EARtone ABR stereo ID earphones EarTone EarCup stereo ID transducer Thermal printer AB1310/AB1310 Bluetooth TDH39 Stereo ID headset DD45 stereo ID headset
TEOAE440 Included parts: Titan handheld unit with basic probe Cradle Power supply (with converter) Clinical probe extension BET55 Ear tips and box Lithium Battery 4 cavities (0.2, 0.5, 2 and 5cc) Titan PC suite with DPOAE440 OtoAccess™ database USB cable, USB adaptor Instructions for Use TCB Carrying Bag Included parts with screener version: Eartip 3-5mm flanged (25 pcs.) Eartip 4-7mm flanged (25 pcs.) Eartip 5-8mm flanged (25 pcs.)
Optional parts: Short probe extension Thermal printer AB1310/AB1310 Bluetooth
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Titan operates with different transducers. The table below shows which transducers are available for use with the Titan. Module
Available transducers
Impedance
Titan probe
Contra phone (acoustic reflexes only) Connects to Shoulderbox: CIR55 (insert) EARTone3A (single insert) (US only) TDH39 (single headphone) DD45 (single headphone) Connects to PreAmp: CIR55 ID transducer (insert) EarTone3A (single insert) ID transducer TDH39 (single headphone) ID transducer DD45 (single headphone) ID transducer
DPOAE
Titan probe
-
TEOAE
Titan probe
-
ABRIS
Titan probe ID EARTone ABR 50Ohm (binaural inserts or ear tips) ID TDH39 (binaural headphones) ID DD45 (binaural headphones) ID EARTone EarCup 50Ohm (binaural EarCups)
-
The shoulder box (used with IMP440/DPOAE440/TEOAE440) contains calibration data for only one contra phone. The specific contra phone is calibrated with the shoulder box and cannot be swapped over to another transducer without changing the calibration data in the shoulder box. The PreAmp (used with IMP440/DPOAE440/TEOAE440/ABRIS440) detects which ID transducer is connected to it and will automatically read the calibration data from the ID transducer. The PreAmp allows you to change from one ID transducer to another at any time as they use the special Omnetics plug. Note: If you want to run contralateral reflex measurements via the PreAmp, you will need a contra phone ID transducer using the Omnetics plug. The contra phone that connects to the (IMP/OAE) shoulder box uses a different plug and is not compatible with the PreAmp. Please contact your dealer if you require a PreAmp compatible contralateral headset (ID transducer).
Titan Instruction for Use - GB
1.4 Warnings Throughout this manual the following mean of warnings, cautions and notices are used: WARNING indicates a hazardous situation which, if not avoided, could result in death or serious injury. CAUTION, used with the safety alert symbol, indicates a hazardous situation which, if not avoided, could result in minor or moderate injury.
NOTICE is used to address practices not related to personal injury.
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Titan Instruction for Use - English
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2 Unpacking and Installation 2.1 Unpaking and Inspection Check box and contents for damage When the instrument is received please check the shipping box for rough handling and damage. If the box is damaged it should be kept until the contents of the shipment have been checked mechanically and electrically. If the instrument is faulty please contact your local distributor. Keep the shipping material for the carrier’s inspection and insurance claim. Keep carton for future shipment Titan comes in its own shipping carton, which is specially designed for the Titan. Please keep this carton. It will be needed if the instrument has to be returned for service. If service is required please contact your local distributor. Reporting Imperfections Inspect before connection Prior to connecting the product it should once more be inspected for damage. All of the cabinet and the accessories should be checked visually for scratches and missing parts. Report immediately any faults Any missing part or malfunction should be reported immediately to the supplier of the instrument together with the invoice, serial number, and a detailed report of the problem. In the back of this manual you will find a "Return Report" where you can describe the problem. Please use "Return Report" Please realize that if the service engineer does not know what problem to look for he may not find it, so using the Return Report will be of great help to us and is your best guarantee that the correction of the problem will be to your satisfaction.
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Marking The following marking can be found on the instrument: Symbol
Explanation Type B applied parts. Patient applied parts that are not conductive and can be immediately released from the patient. Refer to instruction manual
or WEEE (EU-directive) This symbol indicates that when the end-user wishes to discard this product, it must be sent to separate collection facilities for recovery and recycling. Failing to do so may endanger the environment.
0123
The CE-mark indicates that Interacoustics A/S meets the requirements of Annex II of the Medical Device Directive 93/42/EEC. TÜV Product Service, Identification No. 0123, has approved the quality system. Year of manufacture
Do not re-use Parts like ear-tips and similar are for single use only
2.3 Hardware installation When connecting the Titan to the mains supply and to a computer, the following warnings must be observed:
1. External equipment intended for connection to signal input, signal output or other connector, shall comply with the relevant IEC standard (e.g. IEC 60950 for IT equipment and the IEC 60601 series for medical electrical equipment). In addition, all such combinations - systems - shall comply with the standard 60601-1-1, Safety requirements for medical electrical systems. Equipment not complying with IEC 60601 shall be kept outside the patient environment, as defined in the standard (at least 1.5 m from the patient). 2. Any person who connects external equipment to signal input, signal output or other connectors has created a system and is therefore responsible for the system complying with the requirements of IEC 60601-1-1. If in doubt, contact your service technician or local representative for help. 3. In order to comply with IEC 60601, use of the direct power adapter to mains for the thermal printer when it is connected to the cradle is not permitted. The cradle connection provides power for the thermal printer.
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4. In order to maintain a high level of safety it is necessary to have the instrument and its power supply checked according to the medical electrical safety standard IEC 60601-1 on a yearly basis by a qualified service technician.
1. DO NOT connect the Titan hardware to the computer before the software has been installed! 2. Storage in temperatures below 0C /32F and above 50C /122F may cause permanent damage to the instrument and its accessories. 3. Although the instrument fulfils the relevant EMC requirements, precautions should be taken to avoid unnecessary exposure to electromagnetic fields, e.g. from mobile phones etc. If the device is used adjacent to other equipment, caution must be taken to observe that no mutual disturbance appears. 4. The temperature of the battery pack in the thermal printer will rise if it is powered through both the printer’s power supply and through the RJ12 cable to the cradle. Use either one or the other power connections, but never both, as this may severely reduce the lifetime of the battery. 5. The connectors marked with the symbol shown below should not be touched without taking necessary ESD (electrostatic discharge) precautions. 6. The best way to protect the Titan from ESD is to avoid the build-up of electrostatic charges through the use of conductive footwear and floor coverings. Humidification of the air is also an effective preventive means. Failing to comply with these measures can cause the build-up of voltage levels of several thousand volts. If the Titan is subjected to such an ESD pulse, it may be necessary to remove the battery for a few seconds and then restart the instrument. The precautionary symbol:
Within the European Union it is illegal to dispose of electrical and electronic waste as unsorted municipal waste. Electrical and electronic waste may contain hazardous substances and therefore have to be disposed of separately. Such products will be marked with the crossed-out wheelie-bin image shown to the left. User cooperation is important in order to ensure a high level of reuse and recycling of electrical and electronic waste. Failure to recycle such waste products in an appropriate way may endanger the environment and consequently the health of human beings.
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2.4 Installing the cradle Slide off the back plate of the cradle
1
2 3
4
Connect the printer cable to the rear of the cradle (1), power supply (2) and USB cable (4) or optical USB cable (3 and 4). Attach the other end of the USB cable to your PC.
Slide the back plate onto the cradle again.
Place the cradle upright on your desk
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Place the steel cable holder into the holes provided on the back of the cradle.
Mount the spare battery inside the cradle.
Now the cradle is ready to be used with the Titan placed in it.
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2.5 Mounting a Cradle on the wall In order to mount the cradle to the wall you will need the following tools: a drill and a screwdriver. You may need to find out which plugs and screws are best to use depending on the material of the wall. Use the retaining plate of the cradle and a pencil to draw the exact position of the 3 screw holes on the wall. Make sure that the height is chosen in a way that you can still read the Titan display when it is placed in its cradle. Drill the holes and insert the plugs provided. Use three screws to mount the retaining plate to the wall.
Put the power cable, printer cable and USB cable behind the retaining plate. Attach these to the cradle before sliding the cradle onto the retaining plate.
Now the spare battery and Titan can be placed in the cradle.
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2.6 Cradle Indication Lights The LEDs on the cradle indicate the following:
1
2
3
LED 1 will show a solid green light when the Titan is placed inside the cradle and its battery is fully charged. LED 1 will flash green while the battery is charging. LED 2 will show a solid green light when the spare battery is placed inside the cradle and is fully charged. LED 2 will flash green while the battery is charging. LED 3 will show a solid green light when the cradle is attached to the mains power.
2.7 Calibration Cavities and Issues The Titan cradle has a built-in 2cc cavity which can be used for a quick validity check of the probe calibration. You can use the 0.2 ml, 0.5 ml, 2.0 ml and 5.0 ml cylinder cavities for more thorough checks. To perform a calibration check, select a protocol that measures a tympanogram. Do not use an ear tip! Place the probe tip completely into the cavity. Perform the measurement. Check the volume that was measured. The allowed tolerance in the volume measurement is ± 0.1 ml for cavities up to 2 ml and ± 5% for larger cavities. These tolerances are applicable for all probe tone frequencies. We strongly recommended calibrating each probe and contra phone at least once a year. If a probe is handled roughly (e.g. dropped onto a hard surface) it might need to be calibrated again. Calibration values of the probe are stored in the probe itself. Therefore probes can be exchanged at all times. The contra phone is, however, calibrated together with the shoulder box. You should not exchange contra phones from one shoulder box to another without calibrating.
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2.8 Installing the Thermal Printer To charge the printer battery, attach either the printer power adapter to the back of the printer (1), or use the cable which connects the printer to the cradle (2). If Bluetooth is not available on your printer you should charge by using the cable that attaches to the cradle (2).
1
2
The temperature of the battery pack in the thermal printer will increase if it is powered through both the printer’s power supply and through the RJ12 cable to the cradle. Use either one power connection or the other, but never both, as this may severely reduce the lifetime of the battery.
If you want to print out measured results on a Bluetooth connected thermal printer it is recommended to switch on the printer before doing the measurements. This will allow the printer enough time to connect and be ready for printing when measurements are completed.
2.9 Installing Paper in the Thermal Printer
1 2
To open the paper holder press down the button (1).
Place the paper roll in the paper holder with its unfastened end to the front of the printer (as per the image to the left). Close the lid of the paper holder.
After you switch on the printer with button 2, the printer is ready for printing. If you want to switch off or reset the printer: open the paper holder and then press button 2 twice. The printer will automatically shut off when it remains unused for 4 minutes.
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2.10 Installing Bluetooth for direct printing with HP Officejet 100 Mobile Printer or a thermal printer When the Titan is used as a hand held unit it can use Bluetooth to directly print to either a thermal printer or to most Bluetooth PC printers. However, functionality with Bluetooth printers is only guaranteed for the HP Officejet 100 Mobile Printer and other printers compatible for use with the HP Bt500 Bluetooth dongle. In order to use Bluetooth for printing, the Titan print option needs to be setup for connecting to a printer (and not to a PC). Find this setting by switching on Titan and pressing Protocol | My Titan | Titan… Item Bluetooth Connection should be set to “printer”. Change the option by pressing the R or L key on the handheld unit. To install the printer connection you switch on the Titan and press Protocol | My Titan | Printer | Search. When the search is completed, select the serial number and/or type of printer and press Select. Note that most HP printers, according to their manuals, allow direct printing through a USB connection. Connecting the Titan directly through USB will NOT allow you to print. Note that the HP printers allow the use of a pin code for the use of Bluetooth. Titan will NOT be able to print to your printer if this function is used.
2.11 Installing Titan and its battery The battery compartment is opened by gently pressing the indentation and sliding the cover downwards.
Place the battery inside the compartment. Make sure the battery contacts line up with the contacts inside the Titan.
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Replace the cover on the Titan and push it upwards to close the battery compartment. If not in operation for long periods, it is recommended to remove the battery from the Titan.
2.11.1 Charging the Battery Please observe the following precautions:
Keep the battery fully charged. Do not place the battery in a fire or apply heat to the battery. Do not damage the battery or use a damaged battery. Do not expose the battery to water. Do not short circuit the battery or reverse the polarity. Use only the charger provided with the Titan Please see the following section for estimated charging times.
2.11.2 Battery Lifetime and Charging Time When fully charged, the Titan battery will last for a full day of testing under normal test conditions when the default power save and power off is enabled. Typically, the Titan can perform the following number of continuous tests for the various modules: The figures below have been calculated taking into consideration an average test time of 1 minute per test for IMP, DPOAE and TEOAE. A test time of 3 minutes has been used to calculate the number of tests that can be performed in ABRIS. Module
Test (average test times explained above)
Number of tests
IMP440
Tymp, + Reflexes ipsi and contra
200+
DPOAE440
DP-Gram Detailed
200+
ABRIS440
ABR infant screening
75
TEOAE440
TEOAE test
200+
The Titan battery automatically starts charging when placed in the cradle if this is connected to mains power. Keeping the spare battery in the cradle charging compartment means you will always have fully charged spare battery.
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Interacoustics provides a medically approved mains power supply to be used for charging the Titan. A DC USB adaptor can be used to connect the Titan to the medically approved mains power supply when the cradle is not in use. Then the battery in Titan is charged within the same time frame as if it was placed in the cradle. The Titan battery can also be charged via connection to a PC with a USB cable provided. Testing can be performed while the Titan battery is charging. The following table gives an estimate of the charging time (ct) in hours for the battery. Be aware that negative numbers mean that the battery is discharging. Charge times for the spare battery in the cradle and the battery in the Titan while placed in the cradle are the same.
ct through cradle ct through USB up to 80% (PC) up to 80%
ct through cradle up to 100%
ct through USB (PC) up to 100%
Off
1,5
3,8
2,3
5,7
On (not testing)
2,8
-32
4,1
-47
2.12 Changing Probes and Extension Cords on the Titan The Titan probe can be connected in four ways to the device: 1) directly to the Titan 2) using the short extension cord 3) using the long extension cord with the shoulder box (small – for OAE & IMP) 4) using the long extension cord with the PreAmp (large – for OAE/IMP & ABRIS) Note that the length of the tubing influences the pump speed. When the probe is directly connected to the Titan, pump speeds are about 60% higher than when it is connected via the long extension cable with either the shoulder box or PreAmp. For the most accurate measurements it is recommended to use probe while connected via the shoulder box or PreAmp. To release the probe or the extension cable from the Titan, press the button at the back of the Titan and pull the probe or extension cord out while holding onto the base of the probe or extension cable. Do not pull directly on the cord of the extension cable as this can damage the tubing connections! Do not pull directly on the probe tip as this may cause it to break!
Connect the extension cord or probe to the Titan by lining up the red triangles and pushing the probe or extension cable into the connection plate.
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The probe can be attached to the extension cable by lining it up correctly and clicking the probe onto the end.
2.13 Connecting transducers to the shoulder box and PreAmp You can only perform contralateral stimulation during impedance reflex measurements when the shoulder box or PreAmp is connected to the Titan.
When using the shoulder box (for IMP/OAE), plug the jack of the contralateral headphone, insert phone or CIR55 into the shoulder box where it is labeled “Phones Contra”.
1
2
When using the PreAmp, all transducers (contra headphones, TDH39, Insert EarTone 3A etc), except for the probe, are connected via the Omnetics port (1) beside the probe connection plate (2).
2.14 Placing and using the Shoulder Box or PreAmplifier The extension cord with the small shoulder box can be used for impedance and OAE measurements. The PreAmp is required for ABRIS testing and can also be used with all other modules. Use the clip on the back of the shoulder box to attach it to the clothing of the patient. For most patients it may be suitable to attach the shoulder box to the collar of their shirt/blouse. For the PreAmp it may be more suitable to attach it to the strap which can then be placed around the neck of the parent who is holding the patient.
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The shoulder box button (1) can be used for operating the Titan during and in between testing. During PC controlled mode testing, the shoulder box button (1) can be used to START or STOP testing when a seal is maintained in the ear. In between testing, when the probe is out of the ear, pressing the button will change the selected ear from right to left and vice versa.
2 The button (2) on the PreAmp can be used to START or STOP a test.
2.15 Placing the Montage-Indication Stickers on the PreAmplifier A sheet containing Montage-Indication stickers has been enclosed to provide assistance to the user for correct placement of the electrodes and cables. Each sheet contains two stickers; the top one showing the mastoid montage setup and the bottom one showing the nape montage setup.
Remove the required sticker from the sheet and attach to the back of the PreAmplifier.
Ensure that that the safety icon is not covered during sticker placement.