Opti-Amp USB - Intelligent Hearing Systems
Contents
1. 1 00 USBez Enigtibute L Figure 3 Opti Amp with Two Channels Opti Amp USB System Manual 6 2 D E z 0 EEG Channels Each EEG channel will be labeled as such be the channel designation marker as shown in Figure 4 EEG channels contain settings for the Gain High Pass filter and Low Pass filter The Line Filter can be turned ON and OFF using the checkbox on the lower right hand corner The built in line filter will be set to 50 or 60 Hz depending on the electrical supply In your area EEG Channel Designation Channel 1 EEG 3ain High Pass Low Pass hm 1 ma Line Filter 50 60Hz Activator Figure 4 EEG Channel Layout EEG Channels Gain The Opti Amp USB provides eight 8 EEG Gain settings 30k 50k 75K 100k 150k 200k 250k 300k gt WD Listed Gains are the standard gains normally included in the device actual values may vary if your system was special ordered Refer to the drop down gain menus for actual again values that apply to your system Gain settings may be custom made to any eight values between 5k and 500k EEG Channels Filters The Opti Amp USB contains eight 8 Low Pass and eight 8 High Pass filter settings The filter settings indicate the 6 dB amplitude frequency for a single pole RC filter LOW PASS HIGH PASS 1 30 1 1 2 100 2 10 3 300 3 30 4 500 4 50 5 1000 5 100 6 1500 6 152. ta WARNING Read and follow the instructions the Hardware Installation manual when installing or transferring the system Dispose properly of batteries follow the rules and regulations of your area or institution for proper disposal Do not clean ear canal unless you are a certified audiologist or physician trained in this procedure Irreversible injury may result to patient if an unqualified person cleans the ear canal CAUTION Do not operate with damaged cords or plugs Inspect all connection cords periodically for fraying or other damage The power supply provided with the Universal Smart Box is intended for use with that unit only do not attempt to use this power supply with other equipment When connecting all cables do not force the connection damage to the hardware may occur Read and follow the instructions provided in the user manual to ensure safe and proper use of the equipment Ensure that the patient electrode leads are correctly attached and connected to the appropriate plug Inverting the electrode connections may cause incorrect results and misdiagnosis Non medical equipment that will be connected to all IHS devices must comply with the necessary standards for you area Turn off and disconnect all equipment all parts of the equipment when performing maintenance and cleaning Opti Amp USB System Manual 2 E p l 2 m wi Table of Contents
3. Sateby NSA Table of Contents oo decise ne nd se roast nce EU Deor let lii ee QR T TNT 1 FO UOS ie teet mede 1 Product Installation 1 Customer Responsibility 1 WARRANTY baad te edente 2 ER 3 I Parts 3 Hardware Connections esses 3 5 Opti Amp Transmitter 5 E SOLI vos ctas sentirte tta Mc m Site ea D 6 Program 6 EEG Channels 7 a EEG Channels Gaarden 7 EEG Channels 7 OAECheelSo e eret tipo rs 8 Channels Gain eee 8 TA ESSI EOS reet chiesa NNN 8 Program SellBs sanis 9 EEG Electrode Configurations 10 Electrode 10 Programing 15 External CONOS an 15 Available Instructions eee 15 Programming PR 16 Opti Amp USB System Manual lil Introduction Welcome to the Intelligent Hearing Systems family of customers Please be sure to read all the enclose documentation Doing so will allow you to use the equipment safely It will also allow you to maximize the benefits from this great investment Product Features Opti Amp USB is an accessible optical bio amplifier system Some of its features are e Upto eight programmable EEG or OAE channels e
4. WARNING Connect the power cable ONLY when the power switch is in the OFF position failure to do so may damage the equipment Power cables shall be connected to electrical outlets approved by international standard IEC 60601 This is necessary for grounding reliability and proper isolation Connect all cables and verify all connections before turning on the power The System must be tested for leakage current by the biomedical engineering department of your institution The biomedical department of your institution must make sure that the leakage current test results comply with the requirements of your region The system must be tested thoroughly before connecting any patients Computers connected to a network need to be tested for leakage current while connected to the network a network connection may affect total leakage current The System is not explosion proof and must not be used in presence flammable gases or substances The system is not protected against defibrillators Remove patient connections before defibrillation If defibrillation occurs retest the system for leakage current to ensure safety Hazardous electrical output may occur This equipment is for use by qualified personnel only The operator must not touch any of the electrical cables and the patient at the same time Patient connections are not intended for direct cardiac contact although they are electrically isolated E
5. Programmable Gain High Pass Filters and Low Pass Filters e Built in electrical noise notch filter customized for your power supply Opti Amp USB works under the Windows 98SE ME 2000 and XP operating systems This manual assumes that you are familiar with the basic operation of these operating systems and their capabilities Please refer to the operating system manuals when necessary Product Installation To install the Opti Amp USB follow these steps E U T il Insert the installation CD into the computer s CD Drive 2 The Installation program will start automatically 9 oelect the folder where you want the application installed and press the Start Button to proceed 4 Once the software is installed connect the hardware to the computer Refer to page 3 for specific instruction on hardware connections 9 Turn the power switch ON The Switch can be found in the back of the box next to the power plug 6 The computer will automatically detect the device and look for the device driver If the operating system does not find the driver automatically select the IHSUSBAO INF file from the software installation directory The system Is now ready to use Customer Responsibility The equipment its components and included software shall perform reliably as long as It is operated and maintained in accordance with the instructions contained in the manuals associated labels and inserts defective component must not be u
6. USB box 4 and the square end D to the matching output of the Opti Amp transmitter box In two channel systems Red corresponds to the Right channel and Blue corresponds to the Left channel If the system has channels connect the probe s to the corresponding channel input 3 Connect all other necessary cables to the channel outputs 4 for your particular implementation 2 3 4 Figure 1 Opti Amp Connectors and Cables Opti Amp USB Cables 1 Power Input USB Cable Square Connector 2 Power Switch B USB Cable Flat Connector 3 OAE Probe Connector C Fiber Optic Receiver End 4 Fiber Optic Receiver D Fiber Optic Transmitter End 5 BNC Output E Power Cord Connector 6 USB Port F Power Cord Plug Opti Amp USB System Manual Opti Amp Transmitter Box The Opti Amp transmitter box houses the receptacles for the electrodes Transmitters come in single or dual configurations The transmitter converts Bio Electrical Potential signals to light pulses to be transmitted via the optical cable s to the receiver board for optimal isolation and minimal electrical noise The single channel transmitter has an additional switch that allows the user to reverse the electrodes hence selecting the electrodes from which data is to be collected Batteries The Opti Amp transmitter uses two 2 1 5 volt AA size alkaline batteries Be sure not to use rechargeable NiCADs or NiMH batteries these batteries are of a lower voltage level and
7. polarity The polarity is indicated on the battery container After replacing the batteries retest the batteries as previously described For extended battery life always make sure that the rotary switch on the transmitter unit is in the OFF position while not being used Specifications e Frequency Response 1 Hz 5 000 Hz 6 dB e 60 Hz Notch Filter On Off 12 dB e Input Impedance 5 M Ohms e Noise 0 6 Microvolt RMS 1 3 000 Hz e Output single Ended Maximum Swing of 10 volts e Common Mode Rejection gt 113 dB at 1 kHz 105 dB at 60 Hz with notch filter off Size 19cmx 10 cm x 4 cm 7 5 x 4 0 x 1 6 e Weight lt 450 g lt 16 oz Opti Amp USB System Manual 5 Software If the software is not already installed in your computer follow the steps on page 1 The software is accessible from the Windows start menu under the programs gt OptiAmp folder You may also access the program by browsing to the installation directory Program Layout Opti Amp is a multipurpose Bio Electrical Potentials EEG EMG or OAE amplifier system that can be interfaced to any data acquisition hardware A maximum of 8 channels may be added to the USB box assembly The Opti Amp software allows for easy setup of gain and filter settings for each channel independently The program layout will change depending on the number of channels purchased with the Opti Amp as seen on the following figures
8. to copy the text to the Clipboard You should see the appropriate value change on the Opti Amp dialog window Now if you press Control V you will see the confirmation statement i e OK Instruction appear on the Notepad Programming Tips It is important not to lock out the Windows Clipboard by continuously reading or writing to the Clipboard This will not allow other applications to write or read from the Clipboard A delay or interrupt method may be used in order to allow the Opti Amp application time to read and write to the Clipboard It is also important to read the format of the data currently on the clipboard If another application places graphical data on the clipboard reading it as a text may cause your application to crash The Opti Amp program allows you to save the current settings as defaults The next time you run the Opti Amp program all the default settings will be loaded and the Opti Amp hardware programmed accordingly The only way to make sure that all the settings are set as your application desires is to program all the settings each time you run your application If someone changes the settings and saves them as the default settings your application will not know if those values have been changed or not Unless you are sure that no one can modify your settings you should not assume that the loaded default values are the ones you want to use For additional information about controlling Opti Amp from
9. unl Electrode Placement Left Mastoid Right Mastoid RED Test Ear Negative Electrode BLUE Forehead Positive Electrode BLACK Other Ear or Forehead Ground Electrode CAUTION CONNECT TO PATIENT S RIGHT AND LEFT MASTOIDS OPPOSITE FROM YOUR RIGHT amp LEFT WHEN LOOKING AT PATIENT FACE TO FACE Figure 4 Programming External Controls The Opti Amp parameters can also be controlled from another application using the Windows Clipboard to send and receive information To enable this option select the Enable External Program Control check box on the lower right side of the Opti Amp dialog box If you wish this option activated the next time you run the Opti Amp software save the current settings as the Default settings E Opti mp 1 10 USBer Channel 1 EEG Channel 5 EEG Gain High Pass Low Pass tm High Pass Low Pass 5 5 NNNM ale eee Channel 2 FEG Channel 6 EEG Gain High Pass Low Pass nin High Paes Low Pass 30 1 30 i 30 n 30 Channel 3 EEG Channel 7 OAF Gain High Pass Low Pass Gain 30 1 100 Channel 4 EEG Channel Gain High Pass Low Pass High Pass 30 rit 30 Notch aa s gt 30 Motch Settings Load cave Save as Defaults Help Enable External Program Control Figure 6 Opti Amp Main Screen Available Instructions ESNE CHX GAIN n TUNES Channel x Gain to
10. will not let the transmitter box work correctly Note if you will not be using the Opti Amp for a long time take the batteries out of the Opti Amp box place them somewhere else cold and dry As with any other battery powered device leaving the batteries inside for extended periods without use may cause the batteries to leak and damage the transmitter box To take out the batteries turn off the Opti Amp by turning the rotary switch to the off position Open the back of the Opti Amp and take the batteries out from the batteries holder How to Test the Batteries Test the batteries prior to and after patient data acquisition by rotating the switch to the ON position or one of the electrode impedance positions When the switch 1 at the ON position a beeping sound will indicate that the batteries need to be changed When the switch is at one of the electrode impedance positions the Battery Check light will not be lit or will be very dim and the batteries are to be replaced before another patient can be tested If the batteries are still charged the battery check LED Light Emitting Diode will light up and stay bright when the rotary switch is set to any impedance checking position Battery Replacement Instructions When replacing the Opti Amp transmitter batteries open the slot on the transmitter unit Carefully remove both used batteries and replace with two new batteries Make sure the batteries are connected with the correct
11. 0 i 3000 T 300 8 5000 8 500 Opti Amp USB System Manual 7 Listed filters are the standard filters normally included in the device actual filter values may vary if your system was special ordered Refer to the drop down filter menus for actual filter values that apply to your system Filter settings may be custom made to any 16 values between 0 5 Hz and 10 kHz OAE Channels Each channel will be labeled as such be the channel designation marker as shown in Figure 4 OAE channels contain settings for the Gains The TrOAE Filter can be turned ON and OFF using the checkbox on the lower right hand corner OAE Channel Designation Channel 5 OAE Gain 300 p TrOAE TrOAE Filter Activator Figure 5 OAE Channel Layout OAE Channels Gain The Opti Amp USB provides eight 8 OAE Gain settings 100 300 500 1000 2000 4000 8000 10000 Listed Gains are the standard gains normally included in the device actual gain values may vary if your system was special ordered Refer to the drop down gain menus for actual again values that apply to your system Gain settings may be custom made to any eight values up to 10000 TrOAE Filters The use of filters detriments the acquisition of DPOAE data however active filters are necessary for the acquisition of TrOAE data Checking the TrOAE Filter activator will bring online the active filters The active filter has a range of 450 Hz to 5 kHz Make sure you
12. Opti Amp USB Optical Bio Amplifier System Manual Version 1 0 INTELLIGENT REARING HMB OG Intelligent Hearing Systems 6860 SW 81 St Miami Florida 33143 Telephone 305 668 6102 Fax 305 668 6103 Toll Free 1 800 IHSYSTEMS 1 800 447 9783 E mail ins ihsys com Web http www ihsys com Safety Instructions Complying with the following warnings and caution statements will ensure safe operation of the equipment as well as the safety of the users and patients The following labels identify dangerous conditions and their possible effect These symbols are used throughout the manuals WARNING This symbol identifies conditions or practices that may present danger to the patient and or user CAUTION This symbol identifies conditions or practices that could result in damage to the equipment or in incorrect results WARNING When testing human subjects an Isolation Transformer must be used Due to safety considerations the system must be plugged into an Isolation Transformer in order to avoid the risk of electrical shock The computer and printer used with the system must be connected to the same Isolation Transformer Equipment that is not a part of the system and was not provided or approved by IHS must not be connected to the Isolation Transformer The Isolation Transformer must not be placed on the floor to prevent the accidental ingress of fluids Opti Amp USB System Manual
13. acing repairing or issuing credit adjusted to reflect age and use of the product for a system or portion thereof provided that a IHS is notified in writing within 30 days following the discovery of a defect by the buyer b the defective device is returned to IHS and c IHS s examination of the device shall disclose to its satisfaction that i the device has not been repaired or altered by anyone ii any defect has not been caused by misuse neglect or accident and iii the device has not been used for other than normal use 5 I THIS WARRANTY IS EXPRESSLY LIEU OF ALL OTHER WARRANTIES EXPRESS OR IMPLIED WHETHER STATUTORY OR OTHERWISE INCLUDING AN IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE IN NO EVENT SHALL INTELLIGENT HEARING SYSTEMS CORP BE LIABLE FOR ANY INCIDENTAL OR CONSEQUENTIAL DAMAGES RESULTING FROM THE USE OF THIS PRODUCT OR CAUSED BY ANY DEFECT FAILURE OR MALFUNCTION OF THE PRODUCT WHETHER A CLAIM FOR SUCH DAMAGE IS BASED UPON WARRANTY CONTRACT NEGLIGENCE OR OTHERWISE Opti Amp USB System Manual 2 Hardware Parts and Accessories The Opti Amp optical bio amplifier system includes the parts as outlined in the following list If a part is damaged or missing please contact Intelligent Hearing Systems immediately Actual contents of the system depend on the configuration ordered Systems with a single EEG channel will have a single channel transmitter box and a single
14. another application contact Intelligent Hearing Systems Opti Amp USB System Manual 16
15. channel fiber optic cable systems with more than one EEG channels will have one transmitter box for every two EEG channels Systems with one or more OAE channels will include an OAE Probe per channel ordered Pictured Items are not to scale Opti Amp USB Box Opti Amp Transmitter OAE Probe e Bri 4 09 f TE de hr HH USB Cable Medical Power Cord Cus Hardware These items are optional and depend on product configuration see the packing list for actual included items Hardware Connections The Hardware must be properly connected before you are able to use the system Follow these instructions and refer to Figure 1 to connect the system 1 Make sure that the Opti Amp USB box power switch is in the OFF position 2 Connect the Medical Power cord E to the power receptacle found on the back of the box next to the power switch 1 3 Connect the medical power cord plug F to the electrical outlet that you wish to use An Isolation transformer is required for safety purposes specially when testing human subjects Opti Amp USB System Manual 3 Connect the square end of the USB Cable A to the back of the USB connector of the Opti Amp USB 6 Connect the Flat end B to an available USB Port from the target computer If the system has EEG Channels connect the round end of the fiber optic cable to the corresponding connector inputs of the Opti Amp
16. deactivate this option when acquiring DPOAE recordings Opti Amp USB System Manual 8 Program Settings All settings of the program may be saved to file and retrieved for a later use They may also be set as default settings so that those settings are loaded upon start up e Save current settings use the Save button e Load previously saved settings using the Load button e Make the settings default with the Save as Default button Opti Amp settings files have the SET file extension and should preferably be saved to the Settings OptiAmp directory from the installation directory Opti Amp USB System Manual 9 Electrode Configurations Before acquiring data make sure that the optical cable s are properly connected to the receiver and transmitter units and all electrodes are properly connected to the transmitter unit Also make sure the output of the Opti Amp USB Box for the corresponding channel is properly connected to your averaging system Check to see that the power switch on the transmitter box is set to the ON position Example of Electrode Placement ABR The electrodes should be placed according to the following diagrams once in place impedance check is necessary for proper for testing electrode leads are connected to the electrode plugs located on the top cover of the transmitter box Electrodes should ONLY be connected to the Transmitter Box Do not connect electrodes to any other plug or alter the c
17. ircuit to connect electrodes directly to another position One Channel Opti Amp Figure 2 Right mastoid electrode connects to RED plug on Transmitter Box Left mastoid electrode connects to BLUE plug on Transmitter Box High forehead electrode connects to BLACK plug on Transmitter Box NOTE Remember to set the left right switch to the appropriate ear Two Channel Opti Amp testing right left ear only Figures 3A and 3B Test ear mastoid electrode connects to RED plug on Transmitter Box Other ear mastoid electrode connects to BLACK plug on Transmitter Box High forehead electrode connects to BLUE plug on Transmitter Box NOTE Remember to connect electrode leads to the appropriate site on the Opti Amp transmitter box Side A when testing right ear Figure 3A Side B when testing left ear Figure 3B Two Channel Opti Amp testing both ears Figure 4 Test ear mastoid electrode connects to RED plug side A on Transmitter Box Other ear mastoid electrode connects to RED plug side B on Transmitter Box Low forehead electrode connects to BLACK plug on Transmitter Box High forehead electrode connects to BLUE plugs via Y adaptor on Transmitter c iE o W 3 TI Opti Amp USB System Manual 10 Electrode Configuration for 1 Channel Differential Opti Amp Transmitter Black J Channel A Optical Cable Blue TRANSMITTER Electrode Placement tr cx setear switch according to ea
18. option n OPTIAMP CHx HP n Programs Channel x to High Pass option n OPTIAMP CHx LP n Programs Channel x to Low Pass option n Programs Channel x Line Filter On EEG or TrOAE Filter On OAE Programs Channel x Line Filter Off EEG or TrOAE Filter Off OAE OPTIAMP SAVE Saves the current settings as default OPTIAMP CLOSE Closes the Opti Application Example Program The exact syntax may vary depending on the language you are using WinExec OptiAmp Exe Use this or similar instruction to run the Opti Amp software ClipBoard AsText OPTIAMP CH1 GAIN 3 Sets Channel 1 gain to 3 option Delay 1000 Use a delay to wait for OptiAmp to respond to your instruction TempsStr ClipBoard As Text Read the confirmation from OptiAmp If TempStr OK OP TIAMP CH1 GAIN 2 then ShowMessage OK Opti Amp USB System Manual 15 ci 3 p 2 An OK statement followed by the instruction sent indicates that the Opti Amp Software accepted and programmed the instruction An ERROR statement indicates that the Opti Amp software did not understand portion of your instruction The simplest way to test the communications module 1 to run Notepad and type in some instructions Position the Opti Amp software and the Notepad window in such way that you can see both program windows at the same time on your computer screen Type an Opti Amp instruction in Notepad highlight the instruction and press Control
19. r being tested Foreheac Right Left Mastoid Mastoid RED Right Ear Negative when testing right ear Ground when left ear BLUE LeftEar Negative when testing left ear Ground when right ear BLACK Forehead Positive electrode CAUTION CONNECT TO PATIENT S RIGHT AND LEFT MASTOIDS OPPOSITE FROM YOUR RIGHT amp LEFT WHEN LOOKING AT PATIENT FACE TO FACE Figure 2 Electrode Configuration for 2 Channel Differential Opti Amp Transmitter Testing Right Ear Only TRANSMITTER _ Electrode Placement Right Left Mastoid Mastoid RED Test Ear Negative Electrode BLUE Forehead Positive Electrode BLACK Other Ear or Forehead Ground Electrode CAUTION CONNECT TO PATIENT S RIGHT AND LEFT MASTOIDS OPPOSITE FROM YOUR RIGHT amp LEFT WHEN LOOKING AT PATIENT FACE TO FACE Figure 3 A Electrode Configuration for 2 Channel Differential Opti Amp Transmitter Testing Left Ear Only Wi Channel B Optical Cable Blue Red 7 Front View Right Left Mastoid Mastoid TRANSMITTER Electrode Placement RED Test Ear Negative Electrode BLUE Forehead Positive Electrode BLACK Other Ear or Forehead Ground Electrode CAUTION CONNECT TO PATIENT S RIGHT AND LEFT MASTOIDS OPPOSITE FROM YOUR RIGHT amp LEFT WHEN LOOKING AT PATIENT FACE TO FACE Figure 3 B Electrode Configuration for 2 Channel Differential Opti Amp Transmitter Testing Both Ears TRANSMITTER eng
20. sed New IHS manufactured parts should promptly replace broken missing or worn parts If you suspect a part of the equipment to be defective or if you need additional information please contact IHS The responsibility of IHS is limited by the warranty as stated in the technical reference manual Should the repair or replacement of the product become necessary after the end of the warranty period the user must consult IHS before such repair or Opti Amp USB System Manual 1 replacement If the product is in need of repair do not use it until all repairs are completed the unit is functioning properly and is appropriately tested The owner of this product has sole responsibility for the following e Any malfunction resulting from improper use e Maintenance or repairs done by other than IHS e Any malfunction caused by parts that are damaged or modified by anyone other than IHS authorized personnel WARRANTY Opti Amp is manufactured by Intelligent Hearing Systems Corp IHS Miami FL and is sold under the warranty herein set forth The warranty is extended only to the buyer purchasing the device from IHS or an authorized dealer representative IHS warrants this product to be free from defects in workmanship and material under normal use and service and shall conform to its original specifications for a period of one 1 year from the date of delivery The liability of IHS under this warranty is limited at its sole discretion to repl
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