Vivosonic V50 VIVOLINK User Manual USER S MANUAL

Vivosonic, Inc. VIVOLINK USER S MANUAL

Contents

USERS MANUAL 2

Chapter 5 User's Manual Integrity General Operating Procedures Preparing for a test 11049 Rev.2 73 Recommended electrode placement NOTE The patient’s skin must be prepared before the snap electrode pads can be attached. The following electrode placement configurations are recommended for the Amplitrode®, which is optimized for a single-channel recording (Figure 61). [Hall, 1990], [Hall, 1997], [Stapells, 2001] Figure 61 Typical electrode placement diagram - front view Figure 62 Typical electrode placement diagram - left lateral view The recommended electrode sites are: • Non-inverting electrode (active or positive): High forehead (Fz).
General Operating Procedures User's Manual Integrity Chapter 5 74 11049 Rev.2 Preparing for a test • Inverting electrode (reference or negative): Left mastoid (M1), right mastoid (M2), left earlobe (A1), right earlobe (A2); or nape (Oz). • Amplitrode® (ground): low forehead (Fpz); nasion (N); opposite ear lope; or opposite ear canal. ATTENTION To ensure reliable waveforms, the electrode clips must be connected securely to the snap electrode pads. Figure 63 Amplitrode® and Electrode Clips Placement (shown on an infant) Preparing the Patient Skin preparation The patient’s skin must be clear and free of damage, malformations, or disease before starting the test. CAUTION Patients may incur additional skin damage. If the patient’s skin has wounds, scratches, bruises, or any other signs of damage, malformation, or disease do not proceed with the skin preparation or the placement of the electrodes. 1. Visually inspect the area of skin where the electrodes will be placed. If the skin is damaged, do not proceed with the test. 2. Carefully remove oil, dead skin particles, or foreign matter from the skin areas that will be in contact with the snap electrode pads. 3. Remove excessive moisture with a dry cotton ball or gauze pad. 4. Apply abrasive skin preparation cream or jelly on the cleaned skin surface, following the manufacturer’s instructions for use. 5. Remove excessive abrasion cream or jelly with a cotton ball or gauze pad.
Chapter 5 User's Manual Integrity General Operating Procedures Preparing for a test 11049 Rev.2 75 Application of the electrodes Vivosonic recommends starting by connecting the Amplitrode® to the ground electrode connection. Once secure, connect the electrode clips to the snap electrode pads. The non-inverting (+) and inverting (-) electrodes are distinguishable by the “+” and “-” symbols located on the clips’ upper surface. 6. Visually inspect the pouch with single-use electrode pads and check the expiration date indicated on the back of the pouch in the following format “YYYY – MM” (year – month), for example “2005 – 05). 7. Remove the single-use snap electrode pads from the plastic base and paste them on the prepared areas of the patient’s skin. Refer to Figure 61 for details on the recommended locations of the electrodes. 8. Hold the electrode clip with two fingers so that the index finger is in the Holding Groove and the thumb depresses the Electrode Release Button. 9. Snap the Amplitrode® and the two electrode clips onto the electrode pads. When the electrode release button is let go, the electrode will be securely clipped to the electrode pad. 10. Check that the electrode is securely seated on the electrode pad. Figure 64 Amplitrode® (1 – Electrode Release Button 2 – Electrode Clip 3 – Holding Groove) Checking electrode contact quality A unique feature of the Integrity™ system is its ability to monitor the contact quality during ABR data collection. It checks the electrodes continuously to monitor for any changes of quality of its connection to the patient during the test procedure. Contact quality monitoring start when the electrodes are attached to the patient. There are two places to monitor the contact quality, on the VivoLink™ and on the Test screen. Contact Quality on the VivoLink The easiest way of checking the contact quality is to monitor the VivoLink™ contact quality mismatch LED. It is located on the front panel of the VivoLink™ (Figure 5). This LED indicates a poor connection between the electrode and the patient from either the inverting or non-inverting electrodes. When the LED is not lit there is no problem indicated. An Amber lit LED indicates the inverting (-) electrode has poor contact with the patient. A Green lit LED indicates the non-inverting (+) electrode has poor contact with the patient.
General Operating Procedures User's Manual Integrity Chapter 5 76 11049 Rev.2 Preparing for a test Contact Quality from the Test screen The LED indicators represent the quality of the contact between the inverting or non-inverting electrode and the patient’s skin. When the centre LED is lit, shown lit in Figure 28, there is no problem indicated. This is the optimal display representing a good contact quality. When the left (amber) LED indicator is lit this indicates a problem between the connection of the inverting (-) electrode and the patient. When the right (green) LED indicator is lit this indicates a problem between the connection of the non-inverting (+) electrode and the patient. Refer to Figure 29. Correcting poor contact quality A poor connection will affect the results. When the contact quality of one active electrode is poor, follow these steps: 1. Wait for a couple of minutes – the contact quality will often decrease to an acceptable level on its own. 2. If the levels do not change, disconnect the non-functioning electrode (left LED’s for inverting (-), right LED’s for non-inverting (+)). Remove the electrode clip from the snap electrode pad and repeat the skin preparation procedure. 3. Apply a new snap electrode pad and reconnect the electrode clip. 4. Repeat contact quality checking. ATTENTION Identifying poor contact quality for two electrodes If both electrodes have poor contact quality the LED may show only one electrode as being poor or the LED may erratically indicate one electrode and then the other electrode as poor. If after fixing one electrode there is still a problem it is recommended to fix the other electrode before assuming a problem with the Amplitrode®. Choose a transducer To perform an Air-conduction Test, use the ER-3A Earphones. To perform a Bone-conduction Test, select the B-71 Bone Conductor.
Chapter 5 User's Manual Integrity General Operating Procedures Preparing for a test 11049 Rev.2 77 ATTENTION To perform an ABR test with ER-3A earphones the protocol selected must be configured to use the ER-3A Transducer Type. If it is not the stimuli will not be transmitted through the earphones. To perform ABR test with B-71 Bone Conductor the protocol selected must be configured to use the B-71 Transducer Type. If it is not the stimuli will not be transmitted through the bone conductor. ER-3A Earphones To perform ABR or data collection via air conduction, insert ER-3A earphones (Figure 65). Figure 65 ER-3A earphones (a) and their foam ear tip dimensions (b) 1 – Foam ear tip 2 – silicone air-conducting tube inside the foam ear tip If earphones are chosen for testing do the following: 6. Inspect the patient’s ear canal, preferably with an otoscope (not included) for obstructions. If there is an excessive deposit of earwax, have an authorized health-care professional remove the earwax, as defined by local health-care regulations. 7. Observe the patient’s ear canal and evaluate its size. Select an ear tip that would fit tightly yet comfortably in the patient’s ear canal. 8. Install the ear tip onto the earphone as follows: • Choose the ear tip to be installed. • Gently place the ear tip into the earphone tube until there is a full stop. 9. Hold the ear tip with two fingers and compress it. 10. Insert the ear tip into the ear canal: the red transducer into the right ear, and blue into the left ear. Insert the ear tip slowly. Make sure the ear tip is inserted tightly in the cartilaginous part of the ear canal, not in the bony part, which would occlude the ear canal.
General Operating Procedures User's Manual Integrity Chapter 5 78 11049 Rev.2 Preparing for a test CAUTION Do not insert the ear tip in the ear canal too quickly. This may cause excessive positive air pressure in the ear canal being occluded by the ear tip and may hurt the eardrum of the patient. There is a pressure release vent in the transducer, but it may not be sufficient to release excessive air pressure if the ear tip is inserted too quickly. ATTENTION Do not exceed hand force when inserting the ear tip. Make sure the silicone tube inside the ear tip is not bent or pressed. A misaligned tube would result in a change to the acoustic properties and may compromise the calibration or cause potential misdiagnosis. B-71 Bone Conductor To perform data collection using bone conduction, connect the B-71 Bone Conductor to either the left or right mastoid, or the forehead. Secure the headband supplied with the B-71 Bone Conductor. Ensure that the entire circular surface of the Bone Conductor is in full contact with the skin. WARNING Patient may be injured. The Bone Conductor headband is a steel spring designed to hold the bone conductor in place using no more than hand-tightened force. The headband is strong enough to injure the patient if it is released before full contact with the skin. When placing the bone conductor on the patient’s head, do not release the headband until both the bone conductor and the opposite cushioned pad are in full contact with the skin. WARNING Strangulation may occur. Do not put the B-71 Bone Conductor cable around the patient’s neck. Do not leave a patient unattended while preparing and conducting the bone-conduction test!
Chapter 5 User's Manual Integrity General Operating Procedures Protocol Parameters 11049 Rev.2 79 Preparation of the system To prepare for a test, perform the following operations: 1. To ensure there is no visible mechanical damage, inspect the VivoLink™, Amplitrode®, Amplitrode® clips, Amplitrode® connectors, and Amplitrode® cable; ER-3A Insert Earphones and their connectors, cables, and silicone tubes; the B-71 Bone Conductor and its cable and connector. 2. Visually inspect the Amplitrode® and its clips to ensure they are clean of any debris. 3. Place the Amplitrode® and its clips on the parking snaps located on the front panel of the VivoLink™ (Figure 5). CAUTION Do not conduct any AEP test if by visual inspection you discover any visible mechanical damage. Report the problem to Vivosonic’s local service representative or Vivosonic Customer Support. Do not try to repair the device yourself. Do not conduct any AEP test if the Amplitrode® or its clips are congested with any debris which may cause improper electrical contact with the electrode-pad snaps and improper testing. 4. Switch on the computer. 5. Read the two Caution statements (Figure 10 and Figure 11), and choose Agree. Pressing Agree will open the software to the Patients screen (Figure 35). Pressing EXIT will shut down the computer. 6. To be able to perform tests select at least one patient’s name from the list of existing patient or add a new patient name and select it for testing. 7. Switch On the VivoLink™ and monitor the power indicator (Figure 4). The power indicator which is located on the front panel (Figure 5) will turn on green if the batteries in the VivoLink™ are in good working condition. If the battery power is low the indicator will turn amber. Replace the batteries before starting. 8. Check the Bluetooth® connection of the VivoLink™ with the system computer. If connection has been established the VivoLink™ Bluetooth® indicator light ( Figure 20) turns blue. When the connection has been lost the Bluetooth® LED indicator will appear not lit. Protocol Parameters The protocol parameters are entered using ABR Stimulus and Test Settings controls [Hall, 1990], [Hall, 1997], [Stapells, 2002], [Stevens, 2001, (Click)], [Stevens, 2001 (Tone Pip)]. To create a new protocol select an existing protocol and modify it. The parameters, which can be preset in this protocol, are divided into two categories: Stimulus Settings and Test Settings (Figure 53).
General Operating Procedures User's Manual Integrity Chapter 5 80 11049 Rev.2 Protocol Parameters Figure 66 Protocol Stimulus and Test Settings Controls The Stimulus Settings are used to select the stimulation parameters such as stimulus type, stimulus level, maximum number of stimuli, stimulus rate, stimulus window, waveform ramp setting, and the transducer type. The Test Settings control the acquisition conditions of the waveform recording, such as high-pass and low-pass filter settings, high-pass and low-pass filter Rolloff, the amplifier gain, recording window duration, and the artifact rejection threshold (relevant only when using the averaging algorithm). Some test settings can only be modified on the Test screen. (Refer to Protocol Test Settings on page 31 for more details). Stimulus Settings Stimulus Type The following stimulus types can be selected from the drop-down menu: click or tone bursts frequencies of 500 Hz, 1 kHz, 2 kHz, 3 kHz, and 4 kHz. Transducer Type Two transducer types are available from the drop-down menu: the ER-3A earphone and the B-71 Bone Conductor. Stimulus Rate (Stimuli/s) The Stimulus Rate can be set for click and tone-burst stimuli. Select the number of stimuli to produce per second from the range of 7.1 to 99.0 (in 0.1 increments). Changing the Stimulus Rate will result in a change in the wave latency delay and in the early wave’s amplitude. A parameter value can be set by dragging the control bar, and entering the number in it.
Chapter 5 User's Manual Integrity General Operating Procedures Protocol Parameters 11049 Rev.2 81 Maximum Number of Stimuli The Maximum Number of Stimuli depends on the selected Stimulus Rate. For the lowest Stimulus Rate of 7.1 stimuli/s the Maximum Number of Stimuli is 5964. For the highest Stimulus Rate of 99 stimuli/s the Maximum Number of Stimuli is 83160. The smallest value this parameter can be set to is zero (0). The Maximum Number of Stimuli can be selected several different ways: by dragging the control bar, entering the number in the control window, or clicking on the up arrow (to increase the number of stimuli) or down arrow (to decrease the number of stimuli). Window This setting is applicable to the tone-burst stimulation type only. The window defines the shape of the tone-burst waveform, which follows the rise, plateau, and fall portions of the stimulus.The tone-burst signal can be Rectangular, Linear, or Blackman waveform. The Blackman gated window is most commonly used. Ramp This setting is applicable to the tone-burst stimulation type only. The number of sinusoidal waves in the raise, plateau, and fall portions of the tone burst’s waveform is controlled by this parameter. The selections available from the drop-down menu are 2-1-2 or 2-0-2 options. NOTE If Click is selected as the Stimulus Type both the Window and Ramp settings will be unavailable. Stimulus Levels The Stimulus Level defines either multi-level or single-level stimulation. To select a range for multiple level tests, press and hold the Ctrl key on the keyboard and highlight the required levels. TIP During the test session, while viewing the Test screen, it is possible to change the stimulus level using the Level (dB pe SPL) sliding bar (Figure 25). The slider indicates the value of the bottom level of the stimuli selected. When the slider is moved, only the lower end of the selected level range is changed. If only one stimulus level was selected the slider will indicate that value. If the slider is moved it changes the value of the single level. The Stimulus Levels can be selected from a range of values. B-71 50 to 125 dB pe FL, -10 to 65 (1 dB increment) ER-3A 0 to 125 dB pe SPL, -30 to 95 (1 dB increment) For the ABR protocols created for testing using the Insert earphones, levels of stimulation could be expressed in dB nHL or in dB pe SPL depending on the selection made through the System screen.
General Operating Procedures User's Manual Integrity Chapter 5 82 11049 Rev.2 Protocol Parameters The levels of stimulation for testing with Insert Earphones can be selected in a range from -30 to 95 dB nHL or from 0 to 125 in dB pe SPL. For the ABR protocols created for testing using the B-71 Bone Conductor levels of stimulation could be expressed in dB pe FL or dB nHL. Levels of stimulation for testing with bone conduction can be selected in a range from -10 to 50 or 60 dB nHL or from 50 to 110 or 120 in dB FL. Bone vibrator stimulation range depends on the Stimulus Type preset through the Protocol screen. NOTE Air-conducted stimuli are displayed in units of dB nHL or dB pe SPL. The bone-conducted stimuli are displayed in units of dB nHL or dB pe FL. These units are defined in the System screen.(Refer to Selecting the calibration units on page 67 for more details). Test Settings The Test Settings control the acquisition parameters of the ABR recording, such as high-pass filter (HZ), low-pass filter (HZ), high-pass rolloff, low-pass rolloff, amplifier gain, recording window (ms), artifact rejection, and artifact rejection thresholds. High-Pass filter (Hz) The digital high-pass filter is used to filter out low frequency noise. The filter can be set to a value in the range of 30 Hz to 300 Hz. Low-Pass filter (Hz) The digital low-pass filter is used to filter out high frequency noise. The filter can be set to a value in the range of 1000 – 3000 Hz. High-Pass Rolloff and Low-Pass Rolloff Rolloff is defined as the rate of attenuation of a filter, expressed in dB per octave. The High-Pass Rolloff filters the low frequencies and the Low-Pass Rolloff filters the high frequencies. Select the High Pass Rolloff to filter either 6dB/octave or 12dB/octave and the Low Pass Rolloff to filter either 12 dB/octave or 24 dB/octave. Amplifier Gain (dB) This control regulates the post Amplitrode® gain. The available values are 0 (system default), 10, 20, and 40. Recording Window (ms) The Recording Window is a time period after the stimulus is presented to the patient, during which the response is averaged and analyzed. The recording windows can be from 0 ms up to 30 ms. The maximum Recording Window length depends on the Stimulus Rate. From 7.1 to 33.3 Stimuli/s the maximum window is 30 ms, at 33.4 Stimuli/s the maximum window is 29.9 ms and at 99 Stimuli/s the maximum window is 10.1 ms. Artifact Rejection This selection box is used to switch on and off the Artifact Rejection Thresholds. When this control box is selected the Artifact Rejection Thresholds field becomes active. If the control box is not selected the Artifact Rejection Thresholds field is unavailable.
Chapter 5 User's Manual Integrity General Operating Procedures Performing an ABR Test 11049 Rev.2 83 Artifact Rejection Threshold The Artifact Rejection Threshold is used to exclude certain noise levels from the averaging calculations. The value selected (10, 15, 20, or 25 µV) defines the lowest level of the incoming electrophysiological activity which contains excessive electric noise. This field is only accessible when the Artifact Rejection control box is selected. Performing an ABR Test To conduct a measurement, perform the following steps. Place the VivoLink™ on the patient: This procedure includes preparing the skin and connecting the electrodes. Begin with the VivoLink™ Off and the Amplitrode® and electrode clips connected to the parking snaps. Adult patient or an older child: 1. Connect the lanyard clips to the D-rings on the VivoLink™. 2. Disconnect the breakaway of the lanyard and place the longer part of the lanyard around the patient’s neck. 3. Connect the breakaway of the lanyard to the VivoLink™. The patient may then be placed in a chair or on a couch, whichever is more comfortable for the patient and the operator. (Refer to Figure 7.) Infant patient: 1. Place the VivoLink™ next to the infant on a flat surface, close enough for the Amplitrode®, ER-3A, and B-71 Bone Conductor cables to reach the infant. Alternatively, if the infant is held by a caregiver, the caregiver may hold the VivoLink™ in the hands along with the infant. CAUTION Injury to an infant may occur. Do not hold the VivoLink™ or any transducers over the infant’s body or head. If any of the components are accidentally dropped, the infant may be injured. 1. Switch On the VivoLink™. Check the status of the VivoLink™ batteries and Bluetooth® connection. 2. Check that the Impedance Mismatch LED on the VivoLink™ is off (not luminous) while the Amplitrode® and its clips are snapped on the designated parking snaps on the VivoLink™.
General Operating Procedures User's Manual Integrity Chapter 5 84 11049 Rev.2 Performing an ABR Test ATTENTION When the contact quality mismatch LED on the VivoLink™ is On (luminous) it indicates a poor contact between the electrodes and the patient’s skin and may lead to incorrect measurements or misdiagnoses. No light – means that the contact quality is good. Amber light – means that the inverting (-) electrode does not have good contact with the patient’s skin. Check the inverting electrode and if necessary, re-position the electrode, replace the snap electrode pad and prepare the skin again. Green light – means that non-inverting (+) electrode does not have good contact with the patient’s skin. Check the non-inverting electrode and if necessary, re-position the electrode, replace the snap electrode pad and prepare the skin again. 3. Prepare the patient’s skin as described in Skin preparation on page 74. 4. Place the electrode pads on the skin and connect the Amplitrode® and electrode clips as described in Preparing the Patient on page 74. CAUTION Do not use electrodes if their expiration date has passed. 5. To prepare for an air-conduction test, install the ear tip into the testing ear as directed for the ATTENTION To perform an ABR test with ER-3A earphones the protocol selected must be configured to use the ER-3A Transducer Type. If it is not the stimuli will not be transmitted through the earphones. To perform ABR test with B-71 Bone Conductor the protocol selected must be configured to use the B-71 Transducer Type. If it is not the stimuli will not be transmitted through the bone conductor. 6. ER-3A Earphones on page 77.
Chapter 5 User's Manual Integrity General Operating Procedures Performing an ABR Test 11049 Rev.2 85 ATTENTION To ensure proper fit on the transducer and proper operation, use only ear tips supplied by Vivosonic. 7. To prepare for a bone-conduction test, place the B-71 Bone Conductor on the patient’s head. Refer to Application of the electrodes on page 75 for placement details. 8. In the Test Screen, select the type of test to be performed. (Currently only ABR is available.) 9. Select an appropriate protocol in the Applied Protocol drop-down menu. CAUTION Improper configuration of test protocols may result in poor quality test results. Use clinically validated protocols for screening and assessment. 10. Press either the Right Ear or Left Ear button. 11. Press Start. The Start button will change to a Stop button. 12. Monitor the EEG Window (Figure 28) and visually estimate the amplitude of the EEG signal.
General Operating Procedures User's Manual Integrity Chapter 5 86 11049 Rev.2 Performing an ABR Test TIP The noise floor in ABR tests depends on the number of sweeps and the recorded EEG noise. For example, to achieve a 0.1 μV noise floor in an ABR test, you will need to observe the ongoing EEG amplitude within the following limits: For 1,000 sweeps – within approximately ± 2-3 μV, For 2,000 sweeps – within approximately ± 4-5 μV, For 10,000 sweeps – within approximately ± 10 μV, For 1,000,000 sweeps – within approximately ± 100 μV. When excessive noise is found in an AEP test, do the following: • Check the Contact Quality Mismatch LED status and ensure it is Off (not luminous). If it On (luminous) and is amber, check the inverting (-) electrode and replace the electrode or re-prepare the skin area if necessary. If it is On and green, check the non-inverting (+) electrode and replace the electrode or re-prepare the skin if necessary. • Remove the Amplitrode® and its clips from the patient and snap them on the parking snaps of the VivoLink™. • If the noise is still excessively high, relocate the electrodes. • When the noise is reduced, reconnect the Amplitrode® and its clips to the patient and continue patient testing. 13. The instrument performs a test automatically. Pause the test temporarily by pressing Pause. Press Continue or the Stop button to proceed. 14. Whether the data collection is paused or stopped, all the data collected before pressing Pause can be saved by pressing Save. Refer to Test Control Buttons on page 26 for more information about Start/Stop, Pause/Continue, and Save features. TIP Every Start and Stop will create a new record. Save each record to have it displayed on the Test Waveform Window graph while the next test is taking place. If the record is not saved, it will not show on the graph when the next test is started. 15. Press Discard/Clear Graph to clear the Test Waveform Window graph before or after saving the results. If the graph is cleared before the results are saved, the data will be deleted. 16. Press PRINT to print the test results. 17. Repeat the above procedure to test the other ear. 18. Remove the ear tip from the ear. Pull the ear tip from the ear canal slowly. While removing the ear tip, slightly push it to the side to open a gap between the ear tip and the wall of the ear canal. This will allow air to enter the ear canal occluded by the ear tip.
Chapter 5 User's Manual Integrity General Operating Procedures Performing an ABR Test 11049 Rev.2 87 CAUTION Injury to the eardrum may occur. Removing the ear tip from the ear canal too quickly may cause a negative air pressure in the occluded ear canal and result in injury to the eardrum. 19. Dispose of the used ear tip(s). WARNING Choking hazard! To avoid accidental swallowing or inhalation of an ear tip, do not leave the used ear tip(s) within reach of a child. Patients should be attended during preparation or testing. ATTENTION If there is no AEP response for either ear, check that the ER-3A Earphone is producing a sound. Listen to the earphone using a reasonably audible stimulus setting such as 50 dB nHL. 20. Remove the B-71 Bone Conductor from the patient’s head. 21. Carefully remove the electrode pads form the patient’s skin to avoid pain. CAUTION The ear tips and electrode pads are single-use only and should be disposed of immediately after use. To avoid transfer of disease, do not re-use the ear tips or the electrode pads on other patients. 22. Disinfect the Amplitrode® and its clips using disinfecting wipes (included with the Integrity™ system.
General Operating Procedures User's Manual Integrity Chapter 5 88 11049 Rev.2 Performing an ABR Test CAUTION To avoid transfer of disease do not reuse the Amplitrode® and its clips without first disinfecting them. Reviewing results The results can be reviewed from the Database screen or a report of the results can be printed. To review test data: 1. Select the Database tab. 2. Select the patient required. 3. Review the data in the waveform window. 4. Select Expand to view the waveforms full screen. 5. Press Report to add a description of the test. 6. Press Print and Storing the Integrity™ system 1. Press Exit in the top right corner of the Test screen. A dialog box with the following message will appear: “Are you sure you want to exit the instrument?” 2. Press YES to shut down the computer. The screen will turn black. 3. Close the computer lid (recommended to protect the screen and keyboard from collecting excessive dust). 4. Turn the power switch for the computer Off. 5. Turn the optional printer Off. (Refer to the computer and printer manufacturer’s User’s Guide for details.) 6. Unplug the computer power cord from the wall outlet. 7. Pack the VivoLink™ and accessories and place them back into their storage cases.
Chapter 6 User's Manual Integrity Integrity™ System Care Recharging Batteries 11049 Rev.2 89 Chapter 6 Integrity™ System Care Recharging Batteries VivoLink™ Refer to the recharger manufacturer’s User Manual for details on rechargeable Nickel-Metal Hydride batteries. Computer When the computer is running on battery power only, it can typically provide over an hour of testing without re-charging. Refer to the printer manufacturer’s User Manual for instructions on how to monitor the status of the battery, and how to recharge the battery. Replacing Batteries VivoLink™ To replace the batteries: Press lightly on the battery compartment cover and pull the cover in the direction of the arrow on the compartment. Remove the old batteries and dispose of them according to local regulations. Insert four new AA batteries, Ensure that the polarity is correct by aligning the “+” signs on the batteries with the “+” signs on the bottom of each of the four battery compartment cells (Figure 67). Figure 67 Battery compartment of the VivoLink™
Integrity™ System Care User's Manual Integrity Chapter 6 90 11049 Rev.2 Replacing Batteries CAUTION Injury to the patient or operator and damage to the VivoLink™ may occur. If any of the four batteries are installed backwards, the reversed polarity may cause excessive current through this battery. The excessive current can accelerate discharge and leakage of the battery acid, which can burn skin and may permanently damage the device. If the Integrity™ is not going to be used for some time, remove the batteries from the VivoLink™ and store them in a cool, safe place. If the batteries are left in the VivoLink™ for a prolonged period of time they may discharge and leak the battery acid into the battery compartment, which can burn skin and may permanently damage the device. Computer See the computer manufacturer’s User Manual.
Chapter 7 User's Manual Integrity Troubleshooting Problems, Causes and Solutions 11049 Rev.2 91 Chapter 7 Troubleshooting Problems, Causes and Solutions ATTENTION Do not attempt to repair the instrument; this may cause it to function improperly. The Integrity™ System is not a field-repairable instrument. Call your distributor of Vivosonic Customer Support for all repairs. Table 3 Troubleshooting Problems, Causes and Solutions Problem Observed Possible Causes Possible Solutions The computer does not boot. The battery is dead and the computer is not plugged in. The power outlet is not working. The computer is not turned on. • Charge the battery. • Try plugging the computer into a power outlet that is known to work. • Switch the computer ON The ON switch is located in the center of the right side of the computer or check your computer’s user manual. The system starts and operates, but displays error messages. Printer drivers (or other non-Integrity™ system peripheral drivers) installed on the system by the operator may not be compatible with the Integrity™ system. • Please contact Customer support. • Only printer drivers that have been tested and validated by Vivosonic to work with the Integrity™ System may be used. There is no signal from the transducer (ER-3A or B-71). The wrong ear has been chosen. The earphone is not inserted properly. • Verify that the appropriate ear tip is chosen. • Verify that the foam earphone has been placed in the ear canal properly. • Verify the B-71 is affixed properly to the patient. The Bluetooth® wireless connection fails. The VivoLink™ has not been turned on. The VivoLink™ batteries are low or dead. The VivoLink™ is out of range. The software is out of sync. • Make sure that VivoLink™ is switched on. • Check the battery voltage (Figure 18) to make sure that VivoLink™ batteries
Troubleshooting User's Manual Integrity Chapter 7 92 11049 Rev.2 Problems, Causes and Solutions are charged. • Make sure that distance between VivoLink™ and the computer has not exceed 30 ft (10 m). • Press RETRY CONNECTION button. • Switch the VivoLink™ off and on. • Restart the Integrity™. • Refer to the Bluetooth® Troubleshooting section of Appendix J. The EEG signal is above ±40 µV and is not coming down. The electrodes may be poorly placed. • Readjust the electrodes and start again. Cannot change the password The old password is being typed incorrectly. • Check the Num Lock is set if using the number pad. • Check that the Caps Lock is not set. • Verify the password has not been changed already. • Contact customer support. There is no AEP response for either ear while testing with the ER-3A The ear is not getting the stimulus sent from the VivoLink™ • Check that the ER-3A earphone is producing a sound. Listen to the earphone using a reasonably audible stimulus setting such as 50 dB nHL. • Change the ER-3A transducers. • If there is still no sound, call Customer Support to determine if the problem is the connection on the VivoLink™
Chapter 7 User's Manual Integrity Troubleshooting Problems, Causes and Solutions 11049 Rev.2 93 CAUTION Do not install printer drivers and do not use office printers that are not tested and validated to work with the system, and supplied by Vivosonic. This may cause improper instrument functioning, failure to print, and error messages.
Appendix A User's Manual Integrity Technical Specifications 94 11049 Rev.2 Chapter 8 Appendices Appendix A Technical Specifications Intended use Hearing screening and clinical assessment in newborns, infants, children, and adults. Digital Signal Processing (DSP) method The Kalman Weighted method, a patented method using a Linear Minimum Mean-Square Error Filter, also called the Kalman Filter (US Patents 6,463,411 and 6,778,955), is used to estimate ABR signals recording and a time-averaging method. [Li 2002] Test procedure Non-invasive. Patient participation/response Not required – ABR is objective. Diagnostic environment VivoLink™ will perform in a variety of environments (hospital, ambulatory, or home). A sound-proof room is typically not required. Compliant Transducers and cables Compliant with the requirements of EN60601-1-2:2001 Sections 36.201, 36.202 − ER-3A earphones attached to 55.5 ± 2.5 cm cable − B-71 Bone Conductor attached to 72” cable − OAE probe attached to 80 cm cable Compliant Accessories Compliant with the requirements of EN60601-1-2:2001 Sections 36.201, 36.202 Amplitrode® cables length: − between VivoLink™ and ground clip – 1 Meter − between ground clip and “+” clip” – 25 cm − between ground clip and “-“ clip – 40 cm VivoLink™ - wireless interface module Electrode type Single-use Ambu® Neuroline 720-00-S snap electrodes or equivalent. Amplitrode® filters For ABR: 30 – 3000 Hz. Slope: 12 dB/octave. Frequency bands and bandwidth of reception The receiver operates in 79 bands separated by 1MHz, centered at 2402 MHz through 2480 MHz with a bandwidth of +/- 20 parts per million Frequency characteristics of the modulation and the effective radiated power of transmission For all frequencies: Modulation Type: IQ Modulation Frequency Characteristics (where centre frequency F0 = 2F1-F2): Average delta F1 Modulation = 165 kHz (+10/-25 kHz) Maximum delta F2 Modulation = 125 kHz Effective Radiated Power: +1 dBm (+/- 3dB) ABR Numeric Latencies Peak Accuracy of Labeled Peaks Peaks I, II, III, IV, and V, within an accuracy of 0.026 ms. Amplitrode® gain For ABR: 15000, VivoLink™ gain Selectable: 0 dB, 10 dB, 20 dB, and 40 dB. VivoLink™ filters Selectable notch filter settings: 50 Hz, 60 Hz, and “no filter”.
Technical Specifications User's Manual Integrity Appendix A 11049 Rev.2 95 VivoLink™ resolution Analog-to-digital (A/D) conversion (in recording channels): 24 bit. Digital-to-analog (D/A) conversion (in stimulation channels): 16 bit. Automatic pre-testing procedures The measurement of the electrode contact quality. Ear tips Type: Disposable, foam or PVC for AEP testing. Power source The VivoLink™ is powered by four AA batteries. The system ships with eight Nickel-Metal Hydride (NiMH) rechargeable batteries, a charger and 4 AA Alkaline batteries. Electrical path to the patient In ABR test: from the VivoLink™ through the Amplitrode® and Electrodes. There is no electrical hazard to the patient, as the VivoLink™ is battery-operated. The products gained the following regulatory clearances and approvals: • USA: FDA clearance under 510(k) K043396. • Canada: Health Canada Medical Device License No. 67609. • European Union: CE Registration No. DE/CA09/0170/1207 to 1212. • CB Test Certificate CA/023/ITS (testing to standards for safety of electrical equipment) Safety standards compliance Independent testing and audits verified that the products adheres to the following standards: • CB Scheme certificate (Compliance to national deviations for 67 countries) • CSA C22.2 NO 601.1 (R2001) (Medical electrical equipment – general requirements for safety) • EN 980:2003 (Graphical symbols for use in the labeling of medical devices) • EN 55011:1998 (Limits and methods of measurement of Radio disturbance Characteristics of Industrial, Scientific and Medical Radio- Frequency equipment) • EN 60601-1-1 (2001) (Collateral standard: safety requirements for medical electrical systems (Part 1)) • EN 60601-1-2:2003 (Collateral standard. Electromagnetic compatibility requirements and tests) • EN 60601-2-40 (Medical electrical equipment- Particular requirements for the safety of electromyographs and evoked response equipment (IEC 60601-2-40:1998)) • FCC Part 15 (Title 47 CFR Part 15, Radio frequency devices) • IEC 60601-1-4:2000 (General requirements for safety – collateral standard for Programmable electrical medical systems) • ISO 13485:2003 (Medical devices - Quality management systems) • ISO 14971:2000 (Medical devices - Risk management for medical devices) • UL 60601-1:2003 UL (Standard for safety - Medical electrical equipment) Environmental Conditions for Transport and Storage • Ambient temperature of -40C to +70C, • Relative humidity of 10% to 100%, • Atmospheric pressure range of 500hPa to 1060hPa. Potential Electromagnetic or other interference There are no special measures that need to be taken to protect the instrument from interference. However the instrument may be interfered with other equipment, even if this equipment complies with
Appendix A User's Manual Integrity Technical Specifications 96 11049 Rev.2 CISPR emissions requirements. Minimum Computer Requirements • Microsoft® Windows XP® Home or Professional. • Service Pack 1 or above • CPU clock speed >= 1GHz • RAM = 256 Mbytes • Available free hard drive space after installation of operating system = 500 Mbytes • Display resolution = 1024 pixels x 768 pixels • Computer mouse • CD-ROM drive • At least 3 USB ports. Radio frequency related specifications RF Output Power rating: 4 dB mW maximum Operating frequency range: 2.400 – 2.4835 GHz Modulation Types: GFSK Software Integrity™ control software. Printers (optional) Any printer connected to the network shared by the Integrity™ System or any computer configured to run from the Integrity System..
Items tracked in the Integrity Database User's Manual Integrity Appendix B 11049 Rev.2 97 Appendix B Items tracked in the Integrity Database The following items can be entered by the user and tracked by the database. 1. Patient family name 2. Patient give name 3. Hospital ID number 4. Insurance number 5. Mother's family name 6. Mother's given name 7. Gender 8. Ear (Right, Left) 9. Ethnicity 10. Address 11. State/Province 12. Zip/Postal code 13. Country 14. Telephone number 15. Date of birth 16. Time of birth 17. Age (calculated at time of test) 18. Birth Weight (Grams or Pounds:Ounces) 19. High risk registry 20. Patient comment 1 21. Patient comment 2 22. Referring Physician 23. Location of test 24. Mother’s family and give names 25. Mother’s ID number 26. Examiner 27. Date of test. 28. Time of test 29. Protocol name 30. Stimulus parameters (Types of stimuli and levels) 31. Stimulus parameters (Tone frequencies and levels) 32. Stimulus parameters (Modulated frequencies and levels) 33. Number of ABR collected response (calculated) 34. ABR stimulus polarity 35. Transducer type 36. Electrode placement 37. DPOAE levels at test frequencies 38. Noise Floor levels at test frequencies 39. TEOAE response waveform
Appendix B User's Manual Integrity Items tracked in the Integrity Database 98 11049 Rev.2 40. TEOAE levels in user-defined frequency bands 41. TEOAE noise floor in user-defined frequency bands 42. ABR response waveforms 43. Latency values of the ABR peaks 44. I peak latency (positive peak) 45. I’ peak latency (negative peak) 46. II peak latency 47. III peak latency 48. IV peak latency 49. V peak latency (positive) 50. V’ peak latency (negative) 51. I - III inter-peak latency 52. III - V inter-peak latency 53. I – I’ peak-to-peak amplitude 54. V – V’ peak to peak amplitude 55. ABR wave V Input/Output function 56. Type of test(ABR) 57. Test comment 1 58. Test comment 2
ABR Preset Protocols User's Manual Integrity Appendix C 11049 Rev.2 99 Appendix C ABR Preset Protocols ABR air-conducted click threshold protocol Protocol screen settings Stimulus Type Click Transducer Type ER-3A insert earphones Stimulus Rate 27.7 /sec Window Disabled Ramp Disabled High Pass Filter 30 Hz Low pass Filter 1500 Hz High Pass Rolloff 12 dB/oct Low Pass Rolloff 12 dB/oct Amplifier Gain 0 Recoding Window 20 ms Artifact Rejection Disabled Artifact Rejection Threshold Disabled Test screen Algorithm Kalman Polarity Condensation Masker Disabled Masking Level Disabled Noniverting Fz Inverting A1, A2, M1, M2 Recording Side Ipsilateral Notch Filter Disabled Level dB nHL Defined by an Audiologist Neurologic test protocol Protocol screen Stimulus Type Click Transducer Type ER-3A insert earphones Stimulus Rate 17.7 /sec Window Disabled Ramp Disabled High Pass Filter 30 Hz Low pass Filter 3000 Hz High Pass Rolloff 12 dB/oct Low Pass Rolloff 12 dB/oct Amplifier Gain 0 Recoding Window 15 ms Artifact Rejection Disabled
Appendix C User's Manual Integrity ABR Preset Protocols 100 11049 Rev.2 Artifact Rejection Threshold Disabled Test screen Algorithm Kalman Polarity Alternating split Masker Disabled Masking Level Disabled Noniverting Fz Inverting A1, A2, M1, M2 Recording Side Ipsilateral Notch Filter Disabled Level dB nHL 80 dB nHL ABR air-conducted 500 Hz tone-burst threshold protocol Protocol screen Stimulus Type 500 Hz Transducer Type ER-3A insert earphones Stimulus Rate 27.7 /sec Window Blackman Ramp 2-0-2 High Pass Filter 30 Hz Low pass Filter 1500 Hz High Pass Rolloff 12 dB/oct Low Pass Rolloff 12 dB/oct Amplifier Gain 0 Recoding Window 25 ms Artifact Rejection Disabled Artifact Rejection Threshold Disabled Test screen Algorithm Kalman Polarity Condensation Masker Disabled Masking Level Disabled Noniverting Fz Inverting A1, A2, M1, M2 Recording Side Ipsilateral Notch Filter Disabled Level dB nHL Defined by an Audiologist ABR air-conducted 1000 Hz tone-burst threshold protocol Protocol screen
ABR Preset Protocols User's Manual Integrity Appendix C 11049 Rev.2 101 Stimulus Type 1000 Hz Transducer Type ER-3A insert earphones Stimulus Rate 27.7 /sec Window Blackman Ramp 2-0-2 High Pass Filter 30 Hz Low pass Filter 1500 Hz High Pass Rolloff 12 dB/oct Low Pass Rolloff 12 dB/oct Amplifier Gain 0 Recoding Window 25 ms Artifact Rejection Disabled Artifact Rejection Threshold Disabled Test screen Algorithm Kalman Polarity Condensation Masker Disabled Masking Level Disabled Noniverting Fz Inverting A1, A2, M1, M2 Recording Side Ipsilateral Notch Filter Disabled Level dB nHL Defined by an Audiologist ABR air-conducted 2000 Hz tone-burst threshold protocol Protocol screen Stimulus Type 4000 Hz Transducer Type ER-3A insert earphones Stimulus Rate 27.7 /sec Window Blackman Ramp 2-0-2 High Pass Filter 30 Hz Low pass Filter 1500 Hz High Pass Rolloff 12 dB/oct Low Pass Rolloff 12 dB/oct Amplifier Gain 0 Recoding Window 25 ms Artifact Rejection Disabled Artifact Rejection Threshold Disabled Test screen Algorithm Kalman Polarity Condensation
Appendix C User's Manual Integrity ABR Preset Protocols 102 11049 Rev.2 Masker Disabled Masking Level Disabled Noniverting Fz Inverting A1, A2, M1, M2 Recording Side Ipsilateral Notch Filter Disabled Level dB nHL Defined by an Audiologist ABR air-conducted 3000 Hz tone-burst threshold protocol Protocol screen Stimulus Type 3000 Hz Transducer Type ER-3A insert earphones Stimulus Rate 27.7 /sec Window Blackman Ramp 2-0-2 High Pass Filter 30 Hz Low pass Filter 1500 Hz High Pass Rolloff 12 dB/oct Low Pass Rolloff 12 dB/oct Amplifier Gain 0 Recoding Window 25 ms Artifact Rejection Disabled Artifact Rejection Threshold Disabled Test screen Algorithm Kalman Polarity Condensation Masker Disabled Masking Level Disabled Noniverting Fz Inverting A1, A2, M1, M2 Recording Side Ipsilateral Notch Filter Disabled Level dB nHL Defined by an Audiologist ABR air-conducted 4000 Hz tone-burst threshold protocol Protocol screen Stimulus Type 4000 Hz Transducer Type ER-3A insert earphones Stimulus Rate 27.7 /sec
ABR Preset Protocols User's Manual Integrity Appendix C 11049 Rev.2 103 Window Blackman Ramp 2-0-2 High Pass Filter 30 Hz Low pass Filter 1500 Hz High Pass Rolloff 12 dB/oct Low Pass Rolloff 12 dB/oct Amplifier Gain 0 Recoding Window 25 ms Artifact Rejection Disabled Artifact Rejection Threshold Disabled Test screen Algorithm Kalman Polarity Condensation Masker Disabled Masking Level Disabled Noniverting Fz Inverting A1, A2, M1, M2 Recording Side Ipsilateral Notch Filter Disabled Level dB nHL Defined by an Audiologist ABR bone conducted test protocol for click Protocol screen Stimulus Type Click Transducer Type B-71 Stimulus Rate 7.1 /sec Window Disabled Ramp Disabled High Pass Filter 30 Hz Low pass Filter 3000 Hz High Pass Rolloff 12 dB/oct Low Pass Rolloff 12 dB/oct Amplifier Gain 0 Recoding Window 25 ms Artifact Rejection Disabled Artifact Rejection Threshold Disabled Test screen Algorithm Kalman Polarity Alternating split Masker Disabled Masking Level Disabled Noniverting Fz Inverting A1, A2, M1, M2
Appendix C User's Manual Integrity ABR Preset Protocols 104 11049 Rev.2 Recording Side Ipsilateral Notch Filter Disabled Level dB nHL Defined by an Audiologist ABR bone conducted 500 Hz tone-burst threshold protocol Protocol screen Stimulus Type 500 Hz Transducer Type B-71 Stimulus Rate 7.1 /sec Window Blackman Ramp 2-0-2 High Pass Filter 30 Hz Low pass Filter 3000 Hz High Pass Rolloff 12 dB/oct Low Pass Rolloff 12 dB/oct Amplifier Gain 0 Recoding Window 25 ms Artifact Rejection Disabled Artifact Rejection Threshold Disabled Test screen Algorithm Kalman Polarity Alternating split Masker Disabled Masking Level Disabled Noniverting Fz Inverting A1, A2, M1, M2 Recording Side Ipsilateral Notch Filter Disabled Level dB nHL Defined by an Audiologist ABR bone conducted 1000 Hz tone-burst threshold protocol Protocol screen Stimulus Type 1000 Hz Transducer Type B-71 Stimulus Rate 7.1 /sec Window Blackman Ramp 2-0-2 High Pass Filter 30 Hz
ABR Preset Protocols User's Manual Integrity Appendix C 11049 Rev.2 105 Low pass Filter 3000 Hz High Pass Rolloff 12 dB/oct Low Pass Rolloff 12 dB/oct Amplifier Gain 0 Recoding Window 25 ms Artifact Rejection Disabled Artifact Rejection Threshold Disabled Test screen Algorithm Kalman Polarity Alternating split Masker Disabled Masking Level Disabled Noniverting Fz Inverting A1, A2, M1, M2 Recording Side Ipsilateral Notch Filter Disabled Level dB nHL Defined by an Audiologist ABR bone conducted 2000 Hz tone-burst threshold protocol Protocol screen Stimulus Type 2000 Hz Transducer Type B-71 Stimulus Rate 7.1 /sec Window Blackman Ramp 2-0-2 High Pass Filter 30 Hz Low pass Filter 3000 Hz High Pass Rolloff 12 dB/oct Low Pass Rolloff 12 dB/oct Amplifier Gain 0 Recoding Window 25 ms Artifact Rejection Disabled Artifact Rejection Threshold Disabled Test screen Algorithm Kalman Polarity Alternating split Masker Disabled Masking Level Disabled Noniverting Fz Inverting A1, A2, M1, M2 Recording Side Ipsilateral Notch Filter Disabled
Appendix C User's Manual Integrity ABR Preset Protocols 106 11049 Rev.2 Level dB nHL Defined by an Audiologist ABR bone conducted 3000 Hz tone-burst threshold protocol Protocol screen Stimulus Type 3000 Hz Transducer Type B-71 Stimulus Rate 7.1 /sec Window Blackman Ramp 2-0-2 High Pass Filter 30 Hz Low pass Filter 3000 Hz High Pass Rolloff 12 dB/oct Low Pass Rolloff 12 dB/oct Amplifier Gain 0 Recoding Window 25 ms Artifact Rejection Disabled Artifact Rejection Threshold Disabled Test screen Algorithm Kalman Polarity Alternating split Masker Disabled Masking Level Disabled Noniverting Fz Inverting Ai, A2 Recording Side Ipsilateral Notch Filter Disabled Level dB nHL Defined by an Audiologist ABR bone conducted 4000 Hz tone-burst threshold protocol Protocol screen Stimulus Type 4000 Hz Transducer Type B-71 Stimulus Rate 7.1 /sec Window Blackman Ramp 2-0-2 High Pass Filter 30 Hz Low pass Filter 3000 Hz High Pass Rolloff 12 dB/oct Low Pass Rolloff 12 dB/oct
ABR Preset Protocols User's Manual Integrity Appendix C 11049 Rev.2 107 Amplifier Gain 0 Recoding Window 25 ms Artifact Rejection Disabled Artifact Rejection Threshold Disabled Test screen Algorithm Kalman Polarity Alternating split Masker Disabled Masking Level Disabled Non-inverting Fz Inverting A1, A2, M1, M2 Recording Side Ipsilateral Notch Filter Disabled Level dB nHL Defined by an Audiologist
Appendix D User's Manual Integrity Guidance and Manufacturer’s Declaration 108 11049 Rev.2 Appendix D Guidance and Manufacturer’s Declaration Emissions All Equipment and Systems The Integrity™ is intended for use in the electromagnetic environment specified below. The customer or user of the Integrity™ should ensure that it is used in such an environment. Emission Test Compliance Electromagnetic Environment – Guidance RF Emissions CISPR 11 Group 1 The Integrity™ 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 Class B Harmonics IEC 61000-3-2 Class N/A Flicker IEC 61000-3-3 N/A The Integrity™ is suitable for use in all establishments, including domestic, and those directly connected to the public low-voltage power supply network that supplies buildings used for used for domestic purpose. Equipment and Systems that are NOT life-supporting The Integrity™ is intended for use in the electromagnetic environment specified below. The customer or user of the Integrity™ should ensure that it is used in such an environment. Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic Environment- Guidance Portable and mobile communications equipment should be separated from the Integrity™ by no less than the distances calculates/listed below: Conducted RF IEC 61000-4-6 3 Vrms 150 kHz to 80 MHz V1=3 Vrms D=(3.5/V1)(Sqrt P) Radiated RF IEC 61000-4-3 3 V/m 80 MHz to 2.5 MHz E1=3 V/m D=(3.5/V1)(Sqrt P) 80 to 800 MHz D=(7/E1)(Sqrt P) 800 MHz to 2.5 GHz Where P is the max. power (watts) and D is the recommended separation distance (meters). Field strength from fixed transmitters, as determined by an electromagnetic site survey, should be less than the compliance levels (V1 and E1). Interference may occur in the vicinity of equipment containing a transmitter.
Guidance and Manufacturer’s Declaration User's Manual Integrity Appendix D 11049 Rev.2 109 Immunity All Equipment and Systems The Integrity™ is intended for use in the electromagnetic environment specified below. The customer or user of the Integrity™ should ensure that it is used in such an environment Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic Environment Guidance ESD IEC 61000-4-2 ±6kV Contact ±8kV Air ±6kV Contact ±8kV Air Floors should be wood, concrete or ceramic tile. If floors are synthetic, the r/h should be at least 30% EFT IEC 61000-4-4 ±2kV Mains ±1kV I/Os N/A Battery Operated Device N/A Surge IEC 61000-4-5 ±1kV Differential ±2kV Common N/A Battery Operated Device N/A Voltage Dips/Dropout IEC 61000-4-11 >95% Dip for 0.5 Cycle 60% Dip for 5 cycles 30% Dip for 25 Cycles >95% Dip for 5 Seconds N/A Battery Operated Device N/A Power Frequency 50/60 Hz Magnetic Field IEC 61000-4-8 3A/m 3A/m Power frequency magnetic fields should be that of a typical commercial or hospital environment Note: ESD compliance is dependent on a single layer of heat shrink being installed on the insert earphone connector. If this is not installed, the connector shell should not be touched during operation.
Appendix D User's Manual Integrity Guidance and Manufacturer’s Declaration 110 11049 Rev.2 Radio Transmissions 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 instruction manual, 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 of more of the following measures: · Reorient or relocate the receiving antenna · 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. Warning: Changes or modifications not expressly approved by Vivosonic, Inc. could void the user’s authority to operate the equipment This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) this device may not cause harmful interference and (2) this device must accept any interference received, including interference that may cause undesired operation.
Recommended Separation Distance User's Manual Integrity Appendix E 11049 Rev.2 111 Appendix E Recommended Separation Distance This appendix covers the recommended separation distance between portable and mobile radio frequency devices and the Integrity™ system. Equipment and Systems that are NOT life-supporting. The Integrity™ is intended for use in the electromagnetic environment in which radiate disturbances are controlled. The customer or user of the Integrity™ can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile Radio Frequency Communication Equipment and the Integrity™ as recommended below, according to the maximum output power of the communication equipment. Max Output Power (Watts) Separation (m) 150kHz to 80 MHz D= 1.1667(Sqrt P) Separation (m) 80 to 800MNz D=1.1667(Sqrt P) Separation (m) 800MHz to 2.5GHz D=2.3333(Sqrt p) 0.01 0.11667 0.11667 0.23333 0.1 0.36894 0.36894 0.73785 1 1.1667 1.1667 2.3333 10 3.6894 3.6894 7.3785 100 11.667 11.667 23.333
Appendix F User's Manual Integrity Symbols Used on the Instrument 112 11049 Rev.2 Appendix F Symbols Used on the Instrument Label Symbol Description Read accompanying documentation On (power) Off (power) Wireless communication established Standby Impedance REF: Reference or Model Number SN: Serial Number Date of Manufacture Type BF equipment 0120 CE Mark with notified body number 7644CSA 601.1EN 60601-1UL 2601® Entela certification. Input voltage Cell (battery) AA Cell size Alkaline Alkaline battery NiMH Nickel Metal Hydride battery (NiMH) Connector for Amplitrode®. Connector for OAE Probe (not implemented) Connectors for ER-3A earphones (red – the right ear, blue – the left ear)
Symbols Used on the Instrument User's Manual Integrity Appendix F 11049 Rev.2 113 Connector for B-71 Bone Conductor Probe Holder. Parking Snaps for the Amplitrode® and its clips on the VivoLink™. Caution. Fragile. Sensitive to mechanical shock. Made in Canada. FCC mark
Appendix G User's Manual Integrity Overview of Clinical Applications 114 11049 Rev.2 Appendix G Overview of Clinical Applications This is a brief overview of the clinical applications for AEP procedures. Refer to Appendix I for references regarding this information. General Information on ABR What is ABR? Auditory brainstem response (ABR) is an objective electrophysiological test of the function and integrity of the auditory system from the inner ear to the brainstem. ABR is an electrical response starting in the inner ear that travels through the auditory nerve and balance nerve, to the brain stem. What are the clinical applications of ABR? • Hearing screening in newborns. • Estimating hearing levels in difficult to test patients, i.e., mentally disabled, autistic, developmentally delayed, infants and small children. • Evaluating patients with suspected retro-cochlear pathology. • Evaluating patients with Meniere's disease or similar disorders. • Diagnostics of Auditory Neuropathy/Dissynchrony. • Intra-operative monitoring of the function of the Cochlea and the 8th cranial nerve.
ABR Latency Normative Data User's Manual Integrity Appendix H 11049 Rev.2 115 Appendix H ABR Latency Normative Data UCLA School of Medicine Norms for Infants Wave V Mean Latency as Function of Click Table 4 UCLA School of Medicine norms for infants Age in weeks 25 dB 35 dB 45 dB 55 dB 65 dB 75 dB Mean 8.92 8.53 8.05 7.76 7.50 7.24 Newborn SD 0.58 0.68 0.63 0.51 0.50 0.47 Mean 8.50 8.05 7.70 7.37 7.10 6.89 2 wk SD 0.51 0.42 0.40 0.34 0.37 0.36 Mean 8.41 7.98 7.60 7.32 7.07 6.87 4 wk SD 0.45 0.38 0.35 0.35 0.35 0.35 Mean 8.25 7.80 7.46 7.18 6.93 6.73 6 wk SD 0.32 0.32 0.30 0.31 0.28 0.28 Mean 8.13 7.69 7.32 7.04 6.78 6.61 9 wk SD 0.40 0.34 0.32 0.31 0.28 0.26 Mean 8.04 7.63 7.24 6.96 6.76 6.59 12 wk SD 0.36 0.30 0.29 0.29 0.26 0.24 Mean 7.80 7.44 7.10 6.83 6.58 6.38 26 wk SD 0.37 0.46 0.42 0.38 0.31 0.29 Mean 7.32 6.82 6.46 6.10 5.89 5.75 Adult SD 0.40 0.30 0.25 0.23 0.23 0.23 Data collected for a click rate of 33.3 clicks/s. Infants were categorized by chronologic age (weeks after birth). Source: Zimmerman, M.C., Morgan, D.E., Dubno J.R. (1987). Auditory Brain Stem Evoked Response Characteristics in Developing Infants. Annals of Otology, Rhinology, Laryngology, 96, 291-299. Used with permission from the publisher.
Appendix H User's Manual Integrity ABR Latency Normative Data 116 11049 Rev.2 Boys Town Norms for Newborns ABR Latency and Amplitude Values as a Function of Intensity Level in Newborns Table 5 Boys Town norms for newborns Wave V latency (msec) Conception age in weeks 20 dB 40 dB 60 dB 80 dBMean 9.72 8.48 7.62 7.05 33 – 34 SD 0.56 0.49 0.41 0.39 Mean 9.61 8.42 7.58 7.02 35 – 36 SD 0.67 0.54 0.43 0.38 Mean 9.57 8.29 7.45 6.94 37 – 38 SD 0.74 0.51 0.44 0.42 Mean 9.36 8.11 7.30 6.82 39 – 40 SD 0.57 0.49 0.40 0.38 Mean 9.31 8.08 7.20 6.69 41 – 42 SD 0.54 0.35 0.29 0.29 Mean 9.16 7.94 7.08 6.53 43 – 44 SD 0.53 0.51 0.33 0.32 Data collected under the following measurement parameters: stimulus – click, 0.1 msec, 13/sec, monaural, Beyer DT48 earphones; acquisition – filters, 100 – 3000 Hz; amplification, 100,000; sweeps, 1,024; analysis time, 15 msec; electrodes, Cz-Mi. Infants were categorized by Conceptional age in weeks (gestational age at birth plus number of weeks since birth). Source: Gorga, M.P., Reiland, J.K., Beauchaine, K.A., Worthington, D.W, Jesteadt, W. (1987) Auditory brainstem responses from graduates of an intensive care nursery: normal patterns of response. Journal of Speech and Hearing Research, 30, 311-318. Used with permission from ASHA and M. Gorga.
ABR Latency Normative Data User's Manual Integrity Appendix H 11049 Rev.2 117 Boys Town Norms for Infants ABR Latency Values as a Function of Intensity Level in Children Ages 3 Months to 3 Years Table 6 Boys Town norms for infants Latency (msec) Wave V Wave I Age in months 20 dB 40 dB 60 dB 80 dB Mean 8.72 7.43 6.73 6.25 1.59 3 – 6 SD 0.53 0.36 0.33 0.32 0.17 Mean 8.59 7.28 6.56 6.10 1.59 6 – 9 SD 0.61 0.38 0.29 0.26 0.16 Mean 8.31 7.05 6.31 5.90 1.59 9 -12 SD 0.54 0.37 0.29 0.27 0.18 Mean 8.28 7.10 6.30 5.91 1.59 12 – 15 SD 0.60 0.45 0.33 0.27 0.17 Mean 8.33 7.00 6.24 5.84 1.58 15 – 18 SD 0.61 0.38 0.24 0.27 0.14 Mean 8.22 6.95 6.19 5.74 1.55 18 – 21 SD 0.62 0.36 0.18 0.19 0.12 Mean 8.05 6.79 6.14 5.71 1.57 21 – 24 SD 0.58 0.33 0.29 0.26 0.17 Mean 8.30 6.89 6.09 5.71 1.53 24 – 27 SD 0.46 0.29 0.22 0.19 0.14 Mean 7.98 6.75 6.08 5.60 1.59 27 – 30 SD 0.42 0.33 0.28 0.22 0.19 Mean 8.12 6.79 6.07 5.68 1.56 30 – 33 SD 0.53 0.32 0.31 0.27 0.16 Mean 8.10 6.82 6.06 5.68 1.56 33 – 36 SD 0.68 0.38 0.31 0.27 0.15 Data collected under the following measurement parameters: stimulus – click, 0.1 msec, 13/sec, monaural, Beyer DT48 earphones, 0 dB = 30 dB peSPL; acquisition – filters, 100 – 3000 Hz; amplification, 100,000; sweeps, 1,024; analysis time, 15 msec; electrodes, Cz-Mi. Gorga, M.P., Kaminski, J.R., Beauchaine, K.L., Jesteadt, W., Neely, S.T. (1989). Auditory brainstem responses from children three months to three years of age: normal patterns of response. Journal of Speech and Hearing Research, 32, 281-288. Used with permission from ASHA and M. Gorga.
Appendix H User's Manual Integrity ABR Latency Normative Data 118 11049 Rev.2 Absolute and Interwave Latency Values These latency values for the primary components of the ABR Table 7 Absolute and interwave latency values Stimulus Intensity dB nHL I II III IV V I – III III – V I - V Mean 1.53 2.53 3.58 4.56 5.37 2.05 1.79 3.84 90 SD 0.11 0.09 0.09 0.17 0.12 0.14 0.14 0.16 Mean 1.62 2.68 3.68 4.68 5.47 2.06 1.79 3.85 80 SD 0.12 0.11 0.08 0.22 0.12 0.11 0.09 0.14 Mean 1.82 2.79 3.85 4.92 5.64 2.03 1.79 3.82 70 SD 0.17 0.12 0.13 0.24 0.16 0.11 0.12 0.11 Mean 2.04 2.98 4.06 5.11 5.88 2.02 1.72 3.75 60 SD 0.20 0.15 0.21 0.31 0.25 0.12 0.10 0.11 Mean 2.43 3.69 4.60 5.43 6.19 2.02 1.56 3.64 50 SD 0.17 0.10 0.23 0.25 0.32 0.19 0.18 0.19 Mean 3.01 4.05 4.94 5.65 6.65 1.85 1.71 3.60 40 SD 0.25 0.18 0.25 0.49 0.32 1.85 1.71 3.60 Mean - - 5.45 - 7.24 - 1.74 - 30 SD - - 0.30 - 0.42 - 0.26 - Mean - - 5.56 - 7.52 - 1.88 - 20 SD - - 0.57 - 0.63 - 0.23 - Source: Linda J. Hood. Clinical Applications of the Auditory Brainstem Response. Singular Publishing Group, Inc. 1998, San Diego, 285 pages. Used with permission from publisher.
References User's Manual Integrity Appendix I 11049 Rev.2 119 Appendix I References This appendix contains references for The ABR latency and amplitude values, terms, abbreviations, the definitions for the Glossary of Terms, and a summary of clinical applications of ABR found in Appendix G. Gorga, M.P., Reiland, J.K., Beauchaine, K.A., Worthington, D.W, Jesteadt, W. (1987) Auditory brainstem responses from graduates of an intensive care nursery: normal patterns of response. Journal of Speech and Hearing Research, 30, 311-318. Gorga, M.P., Kaminski, J.R., Beauchaine, K.L., Jesteadt, W.,, Neely, S.T. (1989) Auditory brainstem responses from children three months to three years of age: normal patterns of response. Journal of Speech and Hearing Research, 32, 281-288. Hall, J.W., III. Handbook of Auditory Evoked Responses. Allyn and Bacon, 1990, ISBN: 0-205-13566-8. Hall, J., Mueller, G. Audiologists’ Desk Reference: Diagnostic Audiology Principles and Procedures. Singular: San Diego, 1997. ISBN: 1-56593-269-2 Hood, L. Clinical Applications of the Auditory Brainstem Response. Singular: San Diego, 1998. ISBN: 1-56593-200-5. Li, X., Sokolov, Y., Kunov, H. System and method for processing low signal-to-noise ratio signals. US Patent 6,463,411. Oct. 8, 2002. Stevens, Ed. J., Neonatal Hearing Screening and Assessment. Click Auditory Brainstem Response Testing in Babies. A recommended test protocol. 26 November 2001. Source: www.unhs.org.uk Stevens, Ed. J., Neonatal Hearing Screening and Assessment. Auditory Brainstem Response Testing in Babies Using Tone Pip Stimulation. A recommended test protocol. 26 November 2001.. Source: www.unhs.org.uk ASHA, Short Latency Auditory Evoked Potentials. Audiologic Evaluation Working Group on Auditory Evoked Potentials. 1987. Stach, B.A. Comprehensive Dictionary of Audiology. Williams & Wilkins: Baltimore, 1997. ISBN: 0-683-18075-4. Stapells, D. Frequency-Specific Evoked Potential Audiometry in Infants. In: R. Seewald, ed. A Sound Foundation Through Early Amplification 2001. Proceedings of the Second International Conference. Basel, Switzerland, Phonak AG, 2002, pp. 13-31. Zimmerman, M.C., Morgan, D.E., Dubno J.R. (1987). Auditory Brain Stem Evoked Response Characteristics in Developing Infants. Annals of Otology, Rhinology, Laryngology, 96, 291-299. Merriam-Webster Medical Dictionary, (2005). Source: http://www2.merriam-webster.com/cgi-bin/mwmednlm?book=Medical
Appendix I User's Manual Integrity References 120 11049 Rev.2 Glossary of Terms The following definitions are used in this manual and can also be found in the Integrity ™ software instrument screens. The terms shown here where defined using the information referenced in Appendix I. Acoustic coupler Cavity of predetermined shape, volume, and acoustic impedance such as Occluded Ear Simulator (Zwislocki Coupler) that couples the Probe and a measuring microphone of the sound level meter and is used for calibration of stimuli. Air conduction A mode of presenting auditory stimuli via earphones placed over the ear or within the ear canal. Algorithm The algorithm field allows selection of the signal processing algorithm used to combine successive ABR responses. The Integrity(tm) system offers the standard Averaging method and the Kalman Weighted averaging method. Alternating Stimulus Polarity Alternating presentation of rarefaction and condensation polarity stimuli. Amplitrode® An integrated pre-amplifier and electrode into a combined unit for attaching or affixing to a subject. Artifact Unwanted signal that may interfere with the measurement of desired signals. Artifact Rejection Threshold (ART) The sound pressure level in µV above which the detected acoustic signal is considered an artifact.. Auditory Brainstem Response (ABR) Auditory evoked potential originating from the cranial nerve VIII and auditory brainstem structures. Averaging ABR processing algorithm, which uses a standard time averaging technique when equivalent weighting is given to each ABR collected response. Weights assigned to each collected ABR response are based on the noise in that response. Sweeps contaminated with artifacts above a certain artifact-rejection threshold (ART) are excluded from the averaging. Bone vibrator A transducer that is used to present sounds to the skull that reached the Cochlea through the head tissues and bones, i.e. bypassing the middle ear. Channel A single set of inputs into an Auditory Evoked Potential system (e.g., from one pair of electrodes) or a single output from a stimulus generator (e.g., to the right earphone). Click Short-duration, broadband sound produced by applying a short electric pulse to the receiver of the probe, typically around 100 μsec. Click Bandwidth The frequency range of the click spectrum within 6 dB from its maximum. Click Duration (CD) Duration of an electric pulse driving the receiver to elicit a click, in microseconds (μs). Component A peak or wave in the response waveform. Common Mode Rejection (CMR) A noise reduction technique implemented by the differential amplifier where an identical (common) noise at two electrodes is subtracted from the electrophysiologic response. Condensation (Positive) Stimulus Polarity The initial displacement of the stimulus, produced with a positive-voltage electrical signal and an outward movement of the acoustic transducer. Customizable Settings that can be changed by the User. Database An organized collection of data. dB HL A decibel scale referenced to acceptable standards for normal hearing (0 dB is averaged normal hearing for each audiometric test frequency).
References User's Manual Integrity Appendix I 11049 Rev.2 121 dB nHL A decibel scale used in auditory brainstem response measurement referenced to average behavioral thresholds for click or tone burst stimuli collected on a small group of normal hearing patients. dB SPL The logarithmic ratio of the RMS sound pressure of an acoustic signal, Prms to the reference sound pressure, P0 = 20 μPa = 2 * 10-5 Pa, calculated as: SPL (dB) = 20 * log (Prms/P0). dB peSPL The decibel level of a 1000 Hz tone at an amplitude equivalent to the peak of a transient signal such as a click. Eartip A part of the ER-3A earphone, typically made of soft plastic, that is inserted onto the ear canal and used to test for acoustic isolation of the ear canal from the environment. Earphone A device for presenting a sound stimulus to the ear, consisting of an acoustic transducer for converting an electrical signal into sound and a cushion that couples the transducer to the ear. Electroence-phalograph (EEG) An instrument used to study and record brain activity. Envelope (Window) The shape of the overall waveform of an acoustic stimulus that follows the rise, plateau, and fall portions of the stimulus. Epoch A time period, such as the analysis time in evoked response measurement. Fall time The time from the maximum amplitude of the stimulus, or the end of the plateau, to some measure of baseline (zero voltage). Filter An electronic device for eliminating electrical energy in a specific frequency region while allowing other frequencies to pass. Gain Increase in amplitude or energy of an electrical signal amplification. Gain is the difference between the input signal and the output signal. Ground A connection from a piece of electronic equipment, or a person, to the actual ground or a relatively large metal structure that will provide an electrical ground. The ground electrode from a person is connected to the grounding circuit on an evoked response system. A good ground connection reduces electrical interference in evoked response recording. GUI Graphic User Interface High Pass Filter A filter that passes electrical energy above a specific cutoff frequency to eliminate (filters out) energy below that frequency. In situ In the natural position or place on the patient. In situ pre-amplification Pre-amplifies the AEP signal at its scalp with the Amplitrode®, which is positioned on the ground electrode. Inter-peak Latency The difference in milliseconds between two peaks of ABR waveform, such as the difference between the latencies of ABR Wave I and III. Inverting electrode An electrode that is attached to the negative voltage input (inverts the input by 180º) of a differential amplifier. This electrode is typically placed on the earlobe, mastoid, or nape of the neck in ABR recording. Kalman Weighted This signal processing algorithm combines successive ABR responses through the assignment of weights to each response. A higher weight is assigned to "better" responses (i.e. those with less noise contamination). The weights are optimally selected through the use of the Kalman filter, which acts as a linear minimum mean-square error filter. As such, Kalman Weighted signal processing (a) gives less weight to the noise-contaminated responses and (b) emphasizes less noisy responses. In addition, this method processes signals in real time without rejecting any time segments (even those containing significant artifacts). Latency A time interval between two events (e.g. the stimulus and response). Low pass filter A filter that passes electrical energy below a specific cutoff frequency and
Appendix I User's Manual Integrity References 122 11049 Rev.2 eliminates (filters out) energy above the frequency. Masking (Masker) The constant level of the background noise presented to the non-tested ear in an audiometric procedure or ABR measurement. Mastoid A portion of the temporal bone located behind the external ear. Microvolt (μV) One millionth of a Volt. Microsecond (μs) One millionth of a second. Millisecond (ms) One thousandth of a second. nHL Normalized hearing level. The decibel level of sound that lacks a standardized reference, as opposed to standardized pure-tone audiometry levels. It is referred to behaviorally determined normative levels, obtained from a group of normally hearing listeners and expressed in dB nHL. Non-inverting electrode The electrode that is attached to the positive voltage (non-inverting) input of a differential amplifier. This electrode is typically placed on the high forehead in ABR recording. Notch filter A type of filter used in Evoked Response measurement, designated to reduce interference from power line noise – 50 Hz or 60 Hz depending on the region of the world. Notch filter may introduce filter distortion in AEP, and is recommended to be switched off in most tests unless a strong electrical interference is present. Occluded Ear Simulator Occluded ear simulator for the measurement of earphones coupled to the ear with ear inserts, as per IEC 711-1981, ANSI S3.25-1979 (R 1986), for example Brüel & Kjær Ear Simulator Type 4157. Peak A component of an evoked response waveform, or the extreme amplitude for the component; often used to describe-voltage components. Peak equivalent force level (peFL) The numeric value of the sound pressure vibratory force level of a long duration sinusoidal signal which, when fed to the same transducer under the same test conditions has the same peak-to-peak sound pressure of a vibratory force amplitude as the transient signal (click). Peak equivalent sound pressure level (peSPL) The decibel level of a 1000 Hz tone at an amplitude equivalent to the peak of a transient signal such as a click. Polarity The voltage characteristic of the stimulus or waveform response. Response polarity depends on the location of the electrode plugged into the positive input versus the electrode plugged into the negative voltage input of the differential physiological amplifier relative to the neural generator. Preamplifier An electronic device that receives an electric signal, such as an evoked potential, directly from the electrodes, and increases the amplitude of the signal before it is sent on for further processing such as amplification, filtering, and averaging. Protocol A set of parameters, typically user-defined, that instructs the system how to automatically perform a test. It covers stimulus settings, DSP settings, etc. Rarefaction (negative) Stimulus Polarity The initial displacement of the stimulus, produced with a negative-voltage electrical signal and inward movement of the acoustic transducer Rate The number of stimulus repetitions per unit of time, usually 1 second. Repetitions (Sweeps) The number of single reoccurring events, such as a waveform, that are presented in a set period of time. Sound level Sound pressure level indicated by a sound level meter, with dynamic response and weighting characteristics conforming to the requirements of IEC 651 or ANSI S.1.4. When not otherwise qualified, the term denotes a weighted sound level. Stimulus Sound energy presented to the patients through the transducer. Stimulus rate Number of stimuli presented per second. Stimulus level The sound level of an acoustic stimuli as measured in an acoustic coupler, usually an Occluded Ear Simulator (Zwislocki Coupler). In DPOAE tests, the
References User's Manual Integrity Appendix I 11049 Rev.2 123 levels of primaries, are typically presented in the L1/L2format, for example 65/55 dB SPL. Test A complete sequence of stimuli presentation and response recording performed according to a protocol within one test session. Test Type The type of tests measurements performed by a device Tone burst A brief pure tone stimulus having a rapid rise and fall time with a duration sufficient enough to be perceived as having tonality (usually less then 1 sec). Transducer An electroacoustic devise for converting one form of energy into another. VivoLink™ The world’s first wireless interface module used in auditory electrophysiology. It is a universal platform: It can perform ABR, ASSR, DPOAE, and TEOAE tests, and has the potential to add other testing modalities on the same platform. (Note - not all modalities are released yet, only ABR is currently available) It is operated by a microprocessor, controlled from a remote computer through Bluetooth®, and powered by batteries. Wave The rise and fall of a voltage. A wave component is usually attributed to neural activity (action potential or dendritic activity) of a generator or several generators of a response. Wave reproducibility The degree to which a recorded waveform can be reproduced in another similar recording event. Waveform A form or shape of a wave, represented graphically as magnitude in a function of time.
Appendix J User's Manual Integrity Bluetooth® Troubleshooting 124 11049 Rev.2 Appendix J Bluetooth® Troubleshooting Introduction This document has been written to describe the process of troubleshooting the Bluetooth installation. Please read the instructions in their entirety and following the suggestions before calling for technical support. I connect my dongle to my computer and nothing happens If no activity takes place after inserting the Bluetooth dongle to the computer it is because the Bluetooth driver has not been installed. Please follow the Bluetooth driver installation instructions from page - 3 - to page - 18 - of the Installation Instructions to install the drivers and configure the services and security for Bluetooth. I insert the dongle to the back of the computer and the Bluetooth icon in the system tray remains off. If your Bluetooth icon ( ), which is found in the system tray, in the lower right corner of the screen is turned off it could be for the following reasons: 1. The Bluetooth Driver is not properly installed Action - Re-install the Bluetooth driver and ensure that the settings have been configured correctly. 2. the Bluetooth dongle is not plugged in into the proper USB connection. Ensure that the Bluetooth driver is installed and that the dongle is connected to the same port as it was during the driver installation. 3. The Bluetooth dongle may not be connected properly. To ensure that the dongle is properly connected check that the LED on the dongle is lit. If the LED is NOT lit, remove the dongle and then connect it again. I have installed the Bluetooth driver and made the proper connection to the VivoLink but the connection is not recognized after a system shutdown. This problem is usually caused by incorrectly configured Windows® Bluetooth settings. If the Bluetooth driver does not recognize the previous settings do the following: 1. Please follow the installation instructions for the Bluetooth Drivers and Services from page - 3 - to page - 12 -of the Installation Instructions found at the back of this User’s Manual binder.
Index User's Manual Integrity 11049 Rev.2 125 Index % Rejected .................................... 38 AB data ......................................... 38 display....................................... 43 ABR ................................................ 1 ABR test........................................ 84 Access data............................................ 54 Activate protocol ..................................... 64 software..................................... 68 AEP................................................. 2 Algorithms..................................... 4 Alternating .................................... 34 Alternating split ............................ 34 Amplifier Gain.............................. 83 Amplitrode®................................. 19 damage prevention.................... 20 electrodes .................................. 35 Applications................................ 114 Apply electrode.................................... 76 Archive data............................................ 60 Artifact Rejection.......................... 83 Artifact Rejection Threshold......... 84 Audible levels discomfort ................................... 8 Averaging...................................... 34 B-71 stimulation level........................ 37 B-71 Bone Conductor ................... 79 Backup records....................................... 70 Batteries recharging ................................. 90 replacing.................................... 90 Battery compartment ....................... 18, 32 indicator .............................. 12, 32 birth weight units........................................... 68 Blockage ......................................... 7 Bluetooth............................ 3, 11, 15 LED..................................... 26, 32 troubleshoot............................. 124 Calibration....................................... 8 units........................................... 68 Clear window.....................................See Click ............................................. 38 ABR ............................................ 1 Clinic information......................... 72 Clinical Applications .................. 114 Clinical benefits ............................ 20 Components................................... 9 Condensation................................. 34 Configuration.................................. 9 Configure system ....................................... 67 Connection failed ......................................... 33 Connectors accessory................................... 16 Contact quality correcting problem.................... 77 poor ........................................... 40 Test screen ................................ 77 VivoLink LED .......................... 76 Contact Quality............................. 30 LED........................................... 85 Contact Quality mismatcch........... 40 contraindication............................... 7 Contralateral ............................... 36 Correlation Coefficient ................. 38 Create protocol ..................................... 64 Current Day/Time Display...................................... 31
Index User's Manual Integrity 126 11049 Rev.2 Data AB buffered .............................. 38 archive....................................... 60 backing up................................. 70 customize .................................. 56 Discard...................................... 29 export ........................................ 59 lost............................................. 30 merge......................................... 71 Pause ......................................... 28 report......................................... 57 results........................................ 56 save ..................................... 29, 71 select results.............................. 55 view..................................... 26, 53 waveforms................................. 41 Database.......................................... 5 access ........................................ 54 tracked items............................. 98 waveform window .................... 56 Database screen....................... 26, 53 define password ...... 53, 54, 63, 69 expanded view .......................... 60 latency vs intesity graph............ 61 patient list.................................. 54 query ......................................... 56 Date display....................................... 31 incorrect .................................... 32 Date of Birth ................................. 48 Deactivate protocol ..................................... 64 Define battery information.................... 68 birth weight units ...................... 68 password ................. 53, 54, 63, 69 transducer.................................. 68 Delete protocol ..................................... 66 records....................................... 60 test from planner................. 26, 52 waveform .................................. 44 Diagnositc audiometry .................................. 1 Discard data...................................... 29, 46 Display AB............................................. 43 dongle.......................................... 124 Driver Bluetooth................................. 124 DSP ............................................... 95 Ear discharge ..................................... 7 right and left button................... 30 Ear tips................................... 10, 34 Earlobe placement......................... 75 EEG Window................................ 41 Electrode application................................. 76 brand ......................................... 36 contact quality mismatch .......... 40 inverting (-)............................... 35 non-inverting (+)....................... 35 placement............................ 35, 73 Electromagnetic Compatibility....... 6 EMC................................................ 6 Emissions.................................... 109 Environment.................................... 5 ER-3A stimulation level........................ 37 ER-3A Earphones ......................... 78 ERA.............................................. 20 Error measurment................................. 8 Examiner....................................... 52 Expanded view.............................. 60 Export............................................ 59 Filter high and low pass...................... 83 notch.................................... 36, 41 Rolloff....................................... 83 Filters ............................................ 20 Graph Latency vs Intensity............ 38, 61 Y-axis scale............................... 44 Ground placement......................... 75 High-Pass filter ............................. 83 Horizontal.................................... 36 Immunity..................................... 110
Index User's Manual Integrity 11049 Rev.2 127 Impedance indicator .................................... 14 Indications....................................... 6 Inflammation................................... 7 Installation separation distance.................. 111 Integrity Intended use ................................ 1 Integrity system features........................................ 4 setup.......................................... 21 unpackaging.............................. 21 Integrity™ system General Configuration ................ 9 Interference notch filter................................. 36 Ipsilateral..................................... 35 Kalman filter................................. 33 Label peaks ................................... 43, 44 Lanyard ......................................... 16 Latency labels ................................... 43, 44 normative data......................... 115 norms......................................... 44 peak-to-peak data...................... 45 Latency intensity........................... 38 Latency norms............................... 44 international standards .............. 44 LED indicator................................ 11 Level ............................................. 36 List patient........................................ 51 protocol ..................................... 64 Low-Pass filter.............................. 83 Masker........................................... 34 Masking level................................ 34 Mastoid placement........................ 75 Medial........................................... 36 Merge records....................................... 71 Nape placement............................. 75 NeuroLine ..................................... 11 Noise artifacts...................................... 20 Contact Quality......................... 30 masker....................................... 34 masking level............................ 34 Source of..................................... 2 Noise floor .................................... 87 Notch Filter................................... 36 Num of Stim.................................. 38 Number of Stimuli ........................ 38 Operation general procedures .................... 73 Operator .......................................... 5 Password define....................... 53, 54, 63, 69 Patient date/time of birth....................... 48 enter information................. 47, 48 infant ......................................... 12 preparation ................................ 75 print........................................... 31 selecting .............................. 26, 49 status ......................................... 34 Patient screen layout......................................... 63 Patients contraindications......................... 7 indications for ............................. 6 selectable................................... 27 sorting ....................................... 48 Patients screen......................... 26, 47 customizing look....................... 48 Pause and Resume......................... 28 Planner enter information....................... 51 selecting tests ............................ 52 Planner screen............................... 50 Polarity.......................................... 34 Poor contact quality.................... 40 Power ............................................ 13 low battery .......................... 12, 32 Print waveform .................................. 30 Printer setup.......................................... 69
Index User's Manual Integrity 128 11049 Rev.2 Protocol applied....................................... 28 define......................................... 65 parameters................................. 80 preset....................................... 100 settings ...................................... 80 Protocol screen...... 26, 33, 37, 63, 81 define password ...... 53, 54, 63, 69 Query database entries......................... 56 protocol ..................................... 65 Range ............................................ 12 Rarefaction.................................... 34 Recording Window....................... 83 Records archive....................................... 60 delete......................................... 60 References................................... 119 Report............................................ 57 Restore database..................................... 70 Review data............................................ 53 Save data............................................ 29 records....................................... 71 Screens General...................................... 26 Test screen ................................ 26 Select data............................................ 55 printer........................................ 69 Separation Distance .................... 111 Shipping.......................................... 8 Signal Information ........................ 37 Skin damage.................................... 7 Sort database information................. 55 Start/stop....................................... 28 Stimulation polarity...................................... 34 Stimulation level........................... 36 Stimulus Settings................... 80, 81 Stimulus Type............................... 38 Storing........................................... 89 Symbols....................................... 112 System care............................................ 90 preparation ................................ 80 storage....................................... 89 System screen.................... 26, 37, 67 Test plan...................................... 27, 50 type............................................ 28 Test conditions.............................. 51 Test Parameters define............................. 26, 37, 63 Test screen % rejected.................................. 38 algorithm................................... 33 averaging................................... 34 clear........................................... 29 contact quality..................... 30, 40 correlation coefficient............... 38 current day/time ........................ 31 Discard...................................... 29 ear tips....................................... 34 EEG........................................... 41 Kalman filter............................. 34 latency intensity ........................ 38 leave.......................................... 46 level........................................... 36 masker....................................... 34 masking level............................ 34 number of stimuli...................... 38 Patients...................................... 27 pause ......................................... 28 polarity...................................... 34 print........................................... 30 recording side............................ 35 Resume...................................... 28 right ear and left ear................. 30 Save........................................... 29 Start/stop................................... 28 status ......................................... 34 Stimulus type ............................ 38 test plans.................................... 27 Test type.................................... 28 Y-axis scale............................... 44 Test Settings........................... 80, 83 Tone-burst..................................... 38
Index User's Manual Integrity 11049 Rev.2 129 Transducer define......................................... 68 selection .................................... 77 Transducer Type ........................... 38 Troubleshooting............................ 92 Bluetooth................................. 124 Unit ID .......................................... 69 Units birth weight............................... 68 calibration ................................. 68 Values latency....................................... 38 View data...................................... 26, 53 VivoLink Contact Quality......................... 85 VivoLink™ .................................. 11 connector panel......................... 14 front panel................................. 13 placement.................................. 12 Waveform Clear.......................................... 29 data............................................ 45 delete......................................... 44 expanded view .......................... 60 functions of ............................... 56 handles ...................................... 42 label..................................... 43, 44 markup ...................................... 45 Pause ......................................... 28 window...................................... 41 Y-axis scale............................... 44 Waves I and V............................... 44 Wireless connection...................... 33 Y-axis scale................................... 44
INSTALLATION INSTRUCTIONS Installation Instructions, Document 11049 Revision 2 as addendum to User’s Manual
Installation Instructions 11049 Rev.2 - 2 - Table of Figures INSTALLATION SCREEN CAPTURE 1 BLUETOOTH INTRODUCTION ........................................................... - 3 - INSTALLATION SCREEN CAPTURE 2 BLUETOOTH INSTALLATION WELCOME.............................................. - 4 - INSTALLATION SCREEN CAPTURE 3 DESTINATION................................................................................ - 4 - INSTALLATION SCREEN CAPTURE 4 DESTINATION FOLDER ................................................................... - 5 - INSTALLATION SCREEN CAPTURE 5 INSTALLING WIDCOMM ............................................................... - 5 - INSTALLATION SCREEN CAPTURE 6 DRIVER SIGNATURE NOTICE .......................................................... - 6 - INSTALLATION SCREEN CAPTURE 7 WARNING - WINDOWS LOGO TESTING............................................. - 6 - CONFIGURATION SCREEN CAPTURE 1 START | RUN MENU ................................................................... - 7 - CONFIGURATION SCREEN CAPTURE 2 RUN WINDOWS® INF DIRECTORY .............................................. - 7 - CONFIGURATION SCREEN CAPTURE 3 WINDOWS® INF DIRECTORY ...................................................... - 8 - CONFIGURATION SCREEN CAPTURE 4 RUN DEVICE MANAGER ............................................................. - 8 - CONFIGURATION SCREEN CAPTURE 5 DEVICE MANGER ...................................................................... - 9 - CONFIGURATION SCREEN CAPTURE 6 OPTIONS WINDOW ..................................................................... - 9 - CONFIGURATION SCREEN CAPTURE 7 NEW HARDWARE WINDOW....................................................... - 10 - CONFIGURATION SCREEN CAPTURE 8 INSTALL FROM SPECIFIC LOCATION............................................ - 11 - CONFIGURATION SCREEN CAPTURE 9 DEVICE LIST ........................................................................... - 12 - CONFIGURATION SCREEN CAPTURE 10 CONTROL PANEL - CATEGORY VIEW ....................................... - 13 - CONFIGURATION SCREEN CAPTURE 11 CONTROL PANEL - CLASSIC VIEW........................................... - 13 - CONFIGURATION SCREEN CAPTURE 12 INITIAL BLUETOOTH CONFIGURATION WIZARD .......................... - 14 - CONFIGURATION SCREEN CAPTURE 13 BLUETOOTH GENERAL INFORMATION ....................................... - 14 - CONFIGURATION SCREEN CAPTURE 14 SERVICES AVAILABLE............................................................. - 15 - CONFIGURATION SCREEN CAPTURE 15 CONFIGURE SERVICES........................................................... - 15 - CONFIGURATION SCREEN CAPTURE 16 CONGRATULATIONS............................................................... - 16 - CONFIGURATION SCREEN CAPTURE 17 CONFIGURATION - LOCAL SERVICES ........................................ - 16 - CONFIGURATION SCREEN CAPTURE 18 LOCAL SERVICES PROPERTIES DIALOG .................................... - 17 - CONFIGURATION SCREEN CAPTURE 19 CONFIGURATION - CLIENT SERVICES........................................ - 17 - CONFIGURATION SCREEN CAPTURE 20 CLIENT SERVICES PROPERTIES DIALOG.................................... - 18 - CONFIGURATION SCREEN CAPTURE 21 FILES ON INTEGRITY CD ........................................................ - 18 - CONFIGURATION SCREEN CAPTURE 22 CONFIRM REQUIRED SOFTWARE ............................................. - 19 - CONFIGURATION SCREEN CAPTURE 23 BLUETOOTH CONFIGURATION FILES......................................... - 19 - CONFIGURATION SCREEN CAPTURE 24 MSDE INSTALL START........................................................... - 20 - CONFIGURATION SCREEN CAPTURE 25 MSDE INITIALIZATION ........................................................... - 20 - CONFIGURATION SCREEN CAPTURE 26 INTEGRITY INITIALIZATION....................................................... - 21 - CONFIGURATION SCREEN CAPTURE 27 VIVOSONIC WELCOME............................................................ - 21 - CONFIGURATION SCREEN CAPTURE 28 CLOSE SQL SERVER ............................................................ - 22 - CONFIGURATION SCREEN CAPTURE 29 MSDE INSTALLATION ............................................................ - 22 - CONFIGURATION SCREEN CAPTURE 30 VIVOSONIC INSTALLSHIELD WIZARD COMPLETE ........................ - 22 - CONFIGURATION SCREEN CAPTURE 31 BLUETOOTH ICON.................................................................. - 23 - CONFIGURATION SCREEN CAPTURE 32 BLUETOOTH PLACES.............................................................. - 23 - CONFIGURATION SCREEN CAPTURE 33 BLUETOOTH OPTIONS ............................................................ - 23 - CONFIGURATION SCREEN CAPTURE 34 VIVOLINK DEVICE FOUND ....................................................... - 24 - CONFIGURATION SCREEN CAPTURE 35 VIVOLINK DIRECTORY ............................................................ - 24 - CONFIGURATION SCREEN CAPTURE 36 CONNECTING WINDOW AND TASKBAR ...................................... - 25 - CONFIGURATION SCREEN CAPTURE 37 PIN CODE REQUEST .............................................................. - 25 - CONFIGURATION SCREEN CAPTURE 38 COM1................................................................................. - 25 - CONFIGURATION SCREEN CAPTURE 39 CONNECTED......................................................................... - 25 - Installation Instructions Introduction This document will provide step-by-step instructions to install the Integrity™ software. Installation Requirements To properly install Integrity on your system you will need the following:
Installation Instructions 11049 Rev.2 - 3 - • Integrity Install Disk • Bluetooth Dongle • Bluetooth Driver Disk • VivoLink™ • Amplitrode® • Computer with the following system requirements: • 1GHZ Processor • Microsoft® Windows XP® Professional or Home Edition • 256MB of RAM • At least 500MB of available hard-disk space Bluetooth Drivers and Services Before installing Integrity on the system it is important to install and configure the Bluetooth drivers and services. Installing Bluetooth Drivers IMPORTANT Before inserting the Bluetooth Driver CD please ensure that the Bluetooth Dongle is properly connected to the computer. 1. Connect the Bluetooth Dongle to the computer. 2. Insert the disk labeled Bluetooth. Once the disk is in it will automatically start up and the following screen should be displayed. Installation Screen Capture 1 Bluetooth introduction
Installation Instructions 11049 Rev.2 - 4 - 3. Press Dongle BTW 1.4.10. The Bluetooth installation welcome screen will be displayed. 4. Press Next to begin the Bluetooth driver installation. Installation Screen Capture 2 Bluetooth installation welcome NOTE If you have not already installed your Bluetooth Dongle it is important to do so now. 5. Click Next, the license agreement will appear. Read the agreement. 6. Press I accept the terms in the license agreement. The next window that appears is the Destination Folder window. This window will allow you to choose the folder on your computer where the driver files will be installed. Installation Screen Capture 3 Destination
Installation Instructions 11049 Rev.2 - 5 - 7. Press Next to accept the current folder or press Change to change the destination folder of the Bluetooth driver to a different folder. 8. Press Next. The next window that will appear is the installation review window. Installation Screen Capture 4 Destination Folder 9. Press Install to begin the installation of your Bluetooth Driver. Installation window will appear once the installation has begun. Installation Screen Capture 5 Installing WIDCOMM
Installation Instructions 11049 Rev.2 - 6 - 10. When the files are being installed a Drive Signature Notice will be displayed. Press Cancel to continue with the installation. Installation Screen Capture 6 Driver Signature Notice 11. During the installation a warning window will appear stating “The software you are installing has not passed Windows® Logo testing…” The Integrity™ software requires this warning to be bypassed. Please press Continue Anyway. Installation Screen Capture 7 Warning - Windows® Logo Testing NOTE Vivosonic Inc. has verified the compatibility of the Integrity™ software with Windows XP®. 12. The InstallShield Wizard Complete window will be displayed once the driver is completely installed. Press Finish to resume the Bluetooth configuration. Rename a Windows® Bluetooth file. The Bluetooth driver must be configured to be able to properly function with the Integrity™ system.
Installation Instructions 11049 Rev.2 - 7 - Once the initial driver has been installed a specific Windows® Bluetooth file bust be renamed. 13. From the Windows® Start menu select Run. Configuration Screen Capture 1 Start | Run menu 14. Enter %WINDIR%/INF Configuration Screen Capture 2 Run Windows® INF directory 15. Press OK. The Windows® INF directory will open.
Installation Instructions 11049 Rev.2 - 8 - Configuration Screen Capture 3 Windows® INF directory 16. Find the file called Bth.inf. NOTE The file Bth.inf may also be displayed as BTH if your system does not display file extensions. 17. Right-click the file Bth.inf. 18. Select Rename. Rename this file Bth.bak. 19. Press Enter. 20. Close the window by selecting File | Close from the main menu on the top right side of the window. Update the Bluetooth driver 1. From the Windows® Start menu select Run. Refer to Configuration Screen Capture 1. 2. This time type devmgmt.msc in the text field. Configuration Screen Capture 4 Run Device Manager 3. Press OK. A directory listing the different device will display
Installation Instructions 11049 Rev.2 - 9 - Configuration Screen Capture 5 Device Manger 4. Click the sign beside Bluetooth Devices to expand the list of options for Bluetooth. 5. Right-click the first option under Bluetooth Devices, an options window will open. Configuration Screen Capture 6 Options window 6. Select Update Driver… from the options. The Found New Hardware window will open.
Installation Instructions 11049 Rev.2 - 10 - Configuration Screen Capture 7 New Hardware Window 7. Select Yes, this time only. 8. Press Next. The hardware wizard will continue the update. NOTE Windows® may choose the proper CSR USB Bluetooth driver to install the files automatically when Next is pressed. If Windows® did install your drivers automatically proceed to Bluetooth Services Configure the Bluetooth Settings on page - 12 -
Installation Instructions 11049 Rev.2 - 11 - Configuration Screen Capture 8 Install from specific location 9. Select Install from … a specific location (advanced). 10. Press Next. The next window will appear. 11. Select Don’t search. I will choose the driver to install and press Next. Windows® will then scan for all compatible drivers for your Bluetooth device. Once the scan is complete you will be given a list to choose from which may consist of one or more drivers.
Installation Instructions 11049 Rev.2 - 12 - Configuration Screen Capture 9 Device list 12. Select CSR USB Bluetooth Device and press Next. The system will then begin to download all of the appropriate files for the new Bluetooth Driver. Once the download and installation is complete, the Completing the Found New Hardware Wizard window will be displayed. 13. Press Finished. The Bluetooth device drivers are now installed. Bluetooth Services Configure the Bluetooth Settings Once the Bluetooth driver has been installed it is important to properly configure the setting. 1. From the Start menu select Control Panel. Refer to Configuration Screen Capture 1 on page - 7 - 2. Once in Control Panel ensure that it is in Classic View (refer to Configuration Screen Capture 11). If not then select Switch to classic view from the left of the screen of the Category View (Refer to Configuration Screen Capture 10).
Installation Instructions 11049 Rev.2 - 13 - Configuration Screen Capture 10 Control Panel - Category View Configuration Screen Capture 11 Control Panel - Classic View 3. Select Bluetooth Configuration from the list in Control Panel (shown with a circle in the figure above). The Initial Bluetooth Configuration Wizard will open.
Installation Instructions 11049 Rev.2 - 14 - Configuration Screen Capture 12 Initial Bluetooth Configuration Wizard 4. Ensure all the boxes are checked. 5. Press Next. The Bluetooth general information will be displayed. Configuration Screen Capture 13 Bluetooth general information 6. Ensure that the Computer name field contains the name of your computer and that Computer type is properly selected (Windows XP® based computer). 7. Once your computer name is entered the Next button will become selectable. 8. Press Next. 9. The next step is to configure the services available for the Bluetooth. Press Next on the service introduction page to display the services available.
Installation Instructions 11049 Rev.2 - 15 - Configuration Screen Capture 14 Services available 10. The only service Integrity will require is the Bluetooth Serial Port. Ensure the Bluetooth Serial Port service is selected with a check and that all of the other services (including the ones not shown in the figure above) are not selected by clearing their respective checkboxes. 11. Press Next. Windows® will now continue setting the options for Bluetooth. This may take several minutes. Once the settings have been changed the following window will appear. Configuration Screen Capture 15 Configure services 12. Press Skip to continue.
Installation Instructions 11049 Rev.2 - 16 - Configuration Screen Capture 16 Congratulations 13. When the screen reads “Congratulations” the configuration of the Bluetooth driver and setting is complete. 14. Press Finish to close the Bluetooth Configuration Wizard. Bluetooth Security Settings 1. From the Start menu select Control Panel. Refer to Configuration Screen Capture 1 on page - 7 - 2. Select Bluetooth Configuration from the list in Control Panel (shown with a circle in the Configuration Screen Capture 11). This time the Bluetooth Configuration window will open. 3. Select the Local Services tab. Configuration Screen Capture 17 Configuration - local services 4. Highlight Bluetooth Serial Port and press the Properties button on the lower left-hand side of the window. The Bluetooth Properties dialog window will open.
Installation Instructions 11049 Rev.2 - 17 - Configuration Screen Capture 18 Local Services properties dialog 5. Ensure the: Startup Automatically is checked and that the Secure Connection checkbox is not selected. 6. Press Apply and then press OK. This will close the properties dialog and return the Bluetooth Configuration window. Configuration Screen Capture 19 Configuration - client services 7. Select the Client Applications tab. 8. Highlight Bluetooth Serial Port and press the Properties. The properties dialog window will open.
Installation Instructions 11049 Rev.2 - 18 - Configuration Screen Capture 20 Client services properties dialog 9. Ensure that Secure Connection checkbox is not selected. 10. Press Apply and then press OK. This will close the properties dialog and return the Bluetooth Configuration window. Refer to Configuration Screen Capture 19. 11. Press OK to close the Bluetooth Configuration window. This completes the Bluetooth hardware and software configuration for Integrity. Integrity This section of the installation will deal with installing the Integrity system software on the computer. 1. Remove the CD labeled Integrity from its sleeve and place it in the CD tray in the computer. 2. Wait a few seconds for the CD to auto load. If it does not automatically load select Start | My Computer from the bottom left corner of Windows®. Double-click on the CD drive and this will open the directory containing the following files. Configuration Screen Capture 21 Files on Integrity CD
Installation Instructions 11049 Rev.2 - 19 - 3. Double-click Setup.exe to open the InstallShield Wizard and begin the installation. 4. Before the InstallShield starts installing Integrity it first confirms that two required files are on the computer. Refer to Configuration Screen Capture 22. Configuration Screen Capture 22 Confirm required software 5. Press OK. The InstallShield will begin installing the two required files. The first install is the Bluetooth Configuration files which will add certain files to your system used by Integrity’s main install. Configuration Screen Capture 23 Bluetooth configuration files Once the files have been installed the InstallShield prompt for the Microsoft SQL Server 2000 Desktop Engine (MSDE) install to start.
Installation Instructions 11049 Rev.2 - 20 - Configuration Screen Capture 24 MSDE install start 6. Press OK. Configuration Screen Capture 25 MSDE initialization 7. Once MSDE has initialized, it will begin to install onto your machine. 8. When the installation is complete the computer will reboot. 9. Once the computer has finished rebooting, Integrity will initialize for its installation.
Installation Instructions 11049 Rev.2 - 21 - Configuration Screen Capture 26 Integrity initialization 10. When the initialization is complete the Vivosonic welcome screen will be displayed. Configuration Screen Capture 27 Vivosonic welcome 11. Press Install. 12. When the installation is almost complete the SQL Server Service Manager will launch. The SQL Server window can be closed using the at the top-right corner of the window.
Installation Instructions 11049 Rev.2 - 22 - Configuration Screen Capture 28 Close SQL Server 13. When SQL Server Service Manager has been launched a second application (Jet to MSDE) will quickly install and close. Configuration Screen Capture 29 MSDE installation Once the Microsoft SQL Server Desktop Engine has finished running Vivosonic InstallShield Wizard Complete screen will be displayed. Integrity is now installed on the computer. Configuration Screen Capture 30 Vivosonic InstallShield wizard complete Establishing a Connection The wireless connection between VivoLink and the Integrity system must be established.
Installation Instructions 11049 Rev.2 - 23 - 1. Turn on the VivoLink. 2. Double-click the Bluetooth icon on your Windows® taskbar. Configuration Screen Capture 31 Bluetooth icon 3. The Bluetooth Places window will open. Configuration Screen Capture 32 Bluetooth places 4. Select Bluetooth from the main menu. A drop-down list of options will be displayed. 5. Select Search for Devices. Configuration Screen Capture 33 Bluetooth options
Installation Instructions 11049 Rev.2 - 24 - 6. Windows® will begin to look for all Bluetooth Devices. Once Windows® has finished checking for all Bluetooth devices, the VivoLink device should appear. If it does not appear, ensure that the VivoLink is turned on and has sufficient battery power. Configuration Screen Capture 34 VivoLink device found 7. VivoLink should appear with the following name: Vivo SN#XXXX where XXXX is the serial number. 8. Double-click the VivoLink icon. The VivoLink directory will open. Configuration Screen Capture 35 VivoLink directory 9. Double-click the icon labeled COM1 on Vivo SN#XXXX. The system will attempt to connect to the VivoLink. A Connecting message will be displayed at the bottom left-hand corner of the screen. In the Windows® taskbar (bottom right corner) a bubble will appear on the Bluetooth icon.
Installation Instructions 11049 Rev.2 - 25 - Configuration Screen Capture 36 Connecting window and taskbar 10. Double-click the Bluetooth icon in the taskbar. The Bluetooth PIN Code Request window will open. Configuration Screen Capture 37 PIN code request 11. Enter the Bluetooth PIN code - 5150. 12. Press OK. The COM1 window will open. Configuration Screen Capture 38 COM1 13. Press OK. The connecting window will show the message “Connected”. Configuration Screen Capture 39 Connected 14. Close this window using the red X ( ). The Integrity system is ready to be used.
Installation Instructions 11049 Rev.2 - 26 - Calibration Files Installation Instructions Requirements The Integrity system installation instruction must be completed first. If the Integrity system cannot connect to the VivoLink because Integrity has not been installed, please go back and complete this process first. Refer to page - 2 - CAUTION: Possible loss of calibration files This procedure will overwrite calibration files that already exist on the Integrity V500 system. Before beginning this installation it is recommended that the current file directory is backed up. Make a copy of the following file directory: C:\Integrity V1.0\Calibration Data\” Instructions 1. Make sure that the Integrity V500 software is not currently running. 2. Place the Calibration CD into the CD ROM. 3. Copy ALL files from the Calibration CD to the following directory on the Integrity V500 computer: C:\Integrity V1.0\Calibration Data\ 4. Restart the computer. The new calibration files will not be used until the computer is restarted.

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