ICS Chartr 200 VNG/ENG

ICS Chartr 200 VNG/ENG Installation and Startup Guide Doc. No. 7-26-3000-EN/10 Part No. 7-26-30000-EN

Copyrightnotice The manufacturerauthorizes GNOtometrics A/Sto publish manuals approved and released by the manufacturer. 2015, 2016 GN Otometrics A/S. All rights reserved. Otometrics, the Otometrics Icon, AURICAL, MADSEN, ICSand HORTMANN are registered trademarks of GN Otometrics A/Sin the U.S.A. and/or other countries. Versionrelease date 2016-08-09 (139055) Technicalsupport Please contact your supplier. 2 Otometrics - ICS Chartr 200 VNG/ENG

Table of Contents 1 Introduction 5 2 Prepare System for Data Collection 6 3 Prepare Patient for Testing 15 4 Collect Patient Data 18 5 Review and Analyze Collected Data 28 6 Print a Patient Report 43 7 System Options and Settings 48 8 Maintenance and Troubleshooting 51 9 Safety 55 10 Manufacturer 58 11 Technical Specifications 59 12 Installation 68 Otometrics - ICS Chartr 200 VNG/ENG 3

1 Introduction 1 Introduction ICS Chartr 200 VNG/ENG is indicated for videonystagmography and/or electronystagmography testing for patients with a complaint of dizziness or imbalance. The ICS Chartr 200 VNG/ENG Installation and Startup Guide is intended for first time users of the system. It begins with step-by-step instructions for setting up records, preparing the patient, collecting data, reviewing and analyzing data, and preparing reports. The Installation Reference section provides information on setting up the hardware. This guide is organized as follows: Prepare System for Data Collection Prepare Patient for Testing Collect Patient Data Review and Analyze Collected Data Print a Patient Report System Options and Settings Maintenance and Troubleshooting Safety Technical Specifications Installation Once you are comfortable with the basics, take the time to explore the extensive capabilities of the ICS Chartr 200 VNG/ENG system. 1.1 Intended Use The ICS Chartr 200 VNG/ENG is a nystagmograph that is intended to measure, record, and display involuntary movements (nystagmus) of the eyeball. Otometrics - ICS Chartr 200 VNG/ENG 5

2 Prepare System for Data Collection 2 Prepare System for Data Collection 2.1 Step 1 System Startup A. Press the Power button on the PC and wait for the Windows Desktop to display. B. Double-click (ICS VNG or ENG icon) to display the Patient Selection dialog. Alternate: Click the Start button on the Taskbar. Select Programs >GN Otometrics > Chartr 200 VNG/ENG for Windows. C. Click New to prepare the system for a new patient record. Patient Selection Dialog Box Note To comply with HIPAA regulations, the ICS Chartr 200 system relies on Windows password protection. D. Go to Step 2 Start a New Patient Record 7 6 Otometrics - ICS Chartr 200 VNG/ENG

2 Prepare System for Data Collection 2.2 Step 2 Start a New Patient Record A. Complete the patient information. 1. Select the Patient Information tab. 2. Type the patient s Last Name [required] First Name [required] Birth information [required] 3. Select the Gender [required] 4. Type the patient s Address City State, Zip Code (postal code), Country Telephone Number Identification (such as a Medical Record Number, etc.) 5. Click the q and select the Operator. If your name is not on the list go to Step 5 Add an Operator 10. Patient Information Dialog Box, Patient Information Tab Note Click New Patient to create another patient record while an existing patient record is open. B. Go to Step 3 Select a Referring Physician and Facility 8 Otometrics - ICS Chartr 200 VNG/ENG 7

2 Prepare System for Data Collection 2.3 Step 3 Select a Referring Physician and Facility A referring physician can be associated with a patient record. This association is called a Physician Order. A. Select a Referring Physician and Referring Facility. 1. Click the Physician s Order tab 2. Click the q and select the Referring Physician. If not listed, click Info and go to Step 8 Add a Referring Physician 13. 3. Click the q and select a Referring Facility. If not listed, click Info and go to Step 9 Add a Referring Facility 13 4. (optional) Type information about the referral (Referring Notes). This information will appear in the patient report. Patient Information Dialog Box, Physician s Order Tab Note If this patient was tested previously, click New Order to start a new physician order for the patient. B. Go to Step 4 Answer Clinical Information Questions 9. 8 Otometrics - ICS Chartr 200 VNG/ENG

2 Prepare System for Data Collection 2.4 Step 4 Answer Clinical Information Questions The clinical information questions seek information about the patient s general condition, and eye and ear examination findings. This information can be included in the patient report. A. Click the Clinical Information tab. B. Click on a button and answer the questions. 1. Click the Clinical Information tab. 2. Click General and select an option. Click Next to see another question. 3. Click Eye Movement Examination and select an option. Click Next to see another question. 4. Click Ear Examination and select an option. Click Next to see another question. 5. Click the Patient Information tab. Patient Information Dialog Box, Clinical Information Tab C. Click Patient Information tab and click OK. D. Go to Step 5 Add an Operator 10 to modify operator information, Step 6 Modify Operator Options 11 to modify operator options, and Step 7 Modify the Test Battery 12 to modify the test battery. Go to Step 36 Peak Frequency/GDT Interface 50 to modify the German interface. E. Go to Step 10 Study the Main Window 14. Otometrics - ICS Chartr 200 VNG/ENG 9

2 Prepare System for Data Collection 2.5 Step 5 Add an Operator A. Select Edit > Operator Info. B. Complete the operator information. 1. Click New 2. Type your: Last Name [required] First Name [required] Address City State, Zip Code (postal code), Country Telephone Number Identification (such as a work ID, etc.) 3. Click OK Edit Operators C. Go to Step 2 Start a New Patient Record 7 or click F2 New Patient. 10 Otometrics - ICS Chartr 200 VNG/ENG

2 Prepare System for Data Collection 2.6 Step 6 Modify Operator Options Each operator may establish collection, review, and report settings. These settings will be in effect each time the operator s name is selected. A. Select Edit > System Options. Select the Operator Settings/Test Battery tab. B. Customize the Collection, Review, and Report Settings. 1. Click the Operator Settings / Test Battery tab 2. Select an operator. If your name is not on the list, go to Step 5 Add an Operator 10. System Options, Operator Settings/Test Battery Tab 3. Select the Settings Shared by All Operators: Beats Averaged in Peak SPV Calc [x] Automatic Save Caloric Countdown Timer [x secs] Automatic Analysis Automatic Analysis Display Automatic Waveform Filtering Maximum Saccade Latency [x] Omit GN Logo from Printed Report 4. Select the Operator Specific Settings: Require Calibration Before Collection Center Tracings Every [x] secs (except gaze, saccade, tracking) Footswitch/Irrigator Buttons Center waveform during collection Display Lightbar Center Fixation Light Lightbar Brightness [Low, Medium, High] Enable Distance Ranger Show Averaged Saccade and Tracking Values 5. Select Caloric Test Only Settings: Automatic Fixation Light On [x] /Off [x] (secs) Show Directional Preponderance Show Right Ear Data in Red C. Click OK and go to Step 7 Modify the Test Battery 12. Otometrics - ICS Chartr 200 VNG/ENG 11

2 Prepare System for Data Collection 2.7 Step 7 Modify the Test Battery In addition to establishing collection, review, and report settings, each operator may create a customized test battery (testing sequence). A. Select Edit > System Options. Select the Operator Settings/Test Battery tab. B. Arrange the test protocols in the sequence you want to conduct the tests. The Available test protocols (on the left) lists all possible tests. The Selected test protocols (on the right) lists the operator s test sequence. Note: if the hardware is not turned on, the Test Battery Lists will be empty because the available protocols are hardware dependent. 1. Click the Operator Settings / Test Battery tab. 2. Select an operator. If your name is not on the list, go to Step 5 Add an Operator 10 3. Click on a + to show the protocols listed under a procedure. 4. Click on a protocol or procedure to highlight it. 5. Click the Insert >> button to move the highlighted protocol to the selected test protocols (test battery) box. Click the <<Remove removebutton to delete a highlighted protocol or procedure from the test battery. Click the Remove All button to delete all of the protocols and procedures from the test battery. System Options, Operator Settings/Test Battery Tab Click the Default Battery button to use the ICS default test battery. Installation Note: If your facility has a different protocol than what is set up in the default test battery, it is recommended that when you first install the system, you set up a facility default operator test battery. Then add all other operators, and they will inherit the default test battery. If desired, each operator s test battery can be further customized. C. Click OK and go to Step 10 Study the Main Window 14. 12 Otometrics - ICS Chartr 200 VNG/ENG

2 Prepare System for Data Collection 2.8 Step 8 Add a Referring Physician Referring physician records are available to all operators. If the referring physician s name is not on the list, create a new record. A. Click New to start a new record and type the requested information. 1. Click New. 2. Type the physician s: Last Name [required] First Name [required] Address City Zip Code (postal code) Country Identification (work ID, etc.) Telephone number (up to 5) Fax number Email address 3. Click OK. Referring Physician Information Dialog Box B. Click OK to save the record and return to the Patient Information dialog. C. Go to Step 3 Select a Referring Physician and Facility 8 (item A3 Referring Facility). 2.9 Step 9 Add a Referring Facility Referring facility records are available to all operators. If the referring facility s name is not on the list, create a new record. A. Click New to start a new record and type the requested information. Referring Facility Information Dialog Box 1. Click New. 2. Type the facility information: Name [required] Address City State Zip Code (postal code) Country Phone Number Contact Person 3. Click OK. B. Click OK to save the record and return to the Patient Information dialog. Otometrics - ICS Chartr 200 VNG/ENG 13

2 Prepare System for Data Collection C. Go to Step 3 Select a Referring Physician and Facility 8 (item A4 Referring Notes). 2.10 Step 10 Study the Main Window The Main Window is the primary workspace. When a patient record is open, it contains patient test and analysis data. A. Study each area of the Main Window. VNG/ENG Main Window with Patient Data A. Title bar B. Menu bar C. Toolbar D. Waveform Display Area E. Eye image area F. Function keys G. Status bar H. New Test & Review tabs I. New Test/Review area J. Information area K. Text comments B. ENG: go to Step 11 ENG Apply Electrodes 15. VNG: go to Step 13 VNG Place Goggles on Patient 17. 14 Otometrics - ICS Chartr 200 VNG/ENG

3 Prepare Patient for Testing 3 Prepare Patient for Testing 3.1 Step 11 ENG Apply Electrodes The ENG system records 2 or 4 channels of eye movement information. Channel designations relate to electrode placement both on the face and in the electrode patient cable. A. Place electrodes on the patient as needed for 2 or 4 channel collection. Channel Horizontal both (HB) Electrode cable Connections red blue Vertical right (VR) orange white Vertical left (VL) orange white Horizontal right (HR) red black Normal Electrode Placement (4 channels) Horizontal left (HL) blue black Note For 2 channel recordings, use the green and brown openings on the patient cable for the vertical channel. The green and brown electrodes can be placed above and below the right or left eye. B. Connect the electrode leads to the designated color on the patient cable. C. Go to Step 12 ENG Check Electrodes 16. Otometrics - ICS Chartr 200 VNG/ENG 15

3 Prepare Patient for Testing 3.2 Step 12 ENG Check Electrodes Impedance is measured at each skin-electrode interface. A question mark (?) indicates an unacceptable electrode connection. A. Select a protocol in the New Test tab, then click F7 Electrode Test. B. Read the status of each active electrode and channel. 1. Check each electrode connection. 2. Check mv or K Ohm values. 3. Click OK. Electrode Test Dialog Box C. Reapply electrodes or leads as needed. D. Click OK to close the dialog. E. Go to Step 16 Check the Range 21. 16 Otometrics - ICS Chartr 200 VNG/ENG

3 Prepare Patient for Testing 3.3 Step 13 VNG Place Goggles on Patient The video goggles contain video camera lenses and mirrors. The video image displays on the monitor. For more information about how the goggles function, refer to the User Manual. A. Place the VNG video goggles on the patient. Proper placement of the goggles is very important. Refer to the User Manual for detailed instructions. 1. Make sure the mirror is clean. Avoid touching the mirror while placing the goggles on the patient. 2. Place the goggles on the bridge of the patient s nose. 3. Make sure the back head strap is over the back of the patient s head below the inion (bump on the lower part of the skull.) Replace worn head straps. See the User Manual. A. Fine focus adjustment knob. Turn this knob to fine tune (focus) the eye images in the Video Adjustments dialog box. Focus adjustment may be needed if the patient has deepset or protruding eyes. B. Horizontal positioning knob. Turn knob to adjust the horizontal position of the eyes. Adjustment may be needed if the patient has wide-set or close-set eyes. C. Vertical positioning knob. Turn knob to adjust the vertical position of the eyes. VNG Video Goggles B. VNG: Go to Step 14 VNG Center and Focus the Video Image 18 to adjust the video image. C. Go to Step 17 Select a Protocol 22. Otometrics - ICS Chartr 200 VNG/ENG 17

4 Collect Patient Data 4 Collect Patient Data 4.1 Step 14 VNG Center and Focus the Video Image A. Click the New Test tab on the Main Window and choose the eye(s) to be tested. B. Click F7 Video Adjust to display the Video Adjustments dialog. C. Adjust the eye image. 1. Ask the patient to look straight ahead. 2. Move the goggles to center and level the pupils. Make sure the pupils are inside the boxes, as close to the center as possible. 3. Tighten the back head strap until the goggles are snug. The goggles should fit securely so they will not move during positional testing. 4. Straighten and tighten the top head strap to assist in positioning the goggles on the patient s face and positioning the pupils in the box. 5. Use the goggle horizontal and vertical positioning knobs to center each pupil image. 6. Use the goggle focus knobs to focus each image. 7. Repeat as needed to center the pupils and focus the eye images. Video Adjustments Dialog Box, Both Eyes Note For monocular testing, only the selected eye will be visible. If testing both eyes, make sure both eye images display, both pupils are centered, and both eye images are in focus. D. Use the goggle controls (knobs) if needed to align the patient s eyes and focus the image while the patient looks straight ahead. 18 Otometrics - ICS Chartr 200 VNG/ENG

4 Collect Patient Data Caution Do not over tighten the knobs as this may damage the adjustment pieces that hold the mirror. E. Click the Auto Adjust button to move the slides automatically until the pupils begin tracking. Video Adjustments Dialog Box, One Eye F. Go to Step 15 VNG Fine Tune the Video Image 20. Otometrics - ICS Chartr 200 VNG/ENG 19

4 Collect Patient Data 4.2 Step 15 VNG Fine Tune the Video Image A. Use the software controls to fine tune the video image for each eye, if needed. 1. Only the pupil should be blue. There should be none or a minimal amount of blue surrounding the eye (i.e., eyelashes). The crosshair will automatically go where the blue resides, and this should only be the pupil. 2. If the room is very light, close the goggle cover during these adjustments. 3. If needed, move the sliders to manually adjust the threshold, brightness, and contrast to improve the quality of the tracking. 1. Drag the Threshold (A) slider slightly up or down until the pupil tracks properly. 2. Select Adjust Both Eyes to change brightness and contrast for both eyes at the same time 3. Drag the Brightness (B) and Contrast (C) sliders until the image is clear and good tracking is obtained. Video Adjustments Dialog Box B. Ask the patient to look left, right, up, and down. Verify that the crosshairs track both eyes. C. Click OK to accept the video image settings. D. Go to Step 17 Select a Protocol 22. 20 Otometrics - ICS Chartr 200 VNG/ENG

4 Collect Patient Data 4.3 Step 16 Check the Range A range sensor provides a continuous display of patient-to-light bar distance. The acceptable range during testing is 3 feet 8 inches to 4 feet 4 inches (111.8 cm to 132.1 cm). If a patient is out of range for more than 10% of a test, a message displays at the end of the test. A. Click the New Test tab on the Main Window and select a protocol. B. Position the patient in front of the light bar. C. Click F6 Range to activate the range sensor. Range: Distance in feet / inches and centimeters Over Range Under Range During a test, range status updates every 3 seconds and displays in the Information Area of the Main Window. Range Dialog Box D. Click OK to close the dialog and exit the Interpretation Assistant. E. Go to Step 17 Select a Protocol 22. Otometrics - ICS Chartr 200 VNG/ENG 21

4 Collect Patient Data 4.4 Step 17 Select a Protocol A. Click the New Test tab on the left side of the Main Window. New Test tab (A) Procedure (B) Protocol (C) Click on a + sign to show the hidden protocols. Click on a sign to show only the procedure name. New Test Tab B. Choose the eye(s) and the protocol prior to calibrating. 1. Choose the eye(s) to be tested on the toolbar. Eye Buttons on Toolbar 2. Click on a protocol to select it. C. Go to Step 18 Calibrate the Patient 23. 22 Otometrics - ICS Chartr 200 VNG/ENG

4 Collect Patient Data 4.5 Step 18 Calibrate the Patient The horizontal channel should always be calibrated if possible. The vertical channel is more difficult for patients, and it is acceptable to use F3 Default Calibration. To perform an individual eyes calibration, select an individual eyes protocol. A. Make sure the light bar is positioned properly (horizontally or vertically) and the patient is 4 feet (1.2 m) from the bar. B. Select a protocol on the New Test tab on the Main Menu. C. Click F5 Calibrate to access the calibration mode. (Ask the patient to follow the dot of light on the light bar without moving his/her head.) The targets are ±10. They do not extend to the end of the light bar. D. If using Monocular VNG, click F9 Switch Eye to select the eye to be tested. The eye that is grayed out is the currently selected eye. 1. Click F9 Switch Eye to change the selected eye. 2. View selected protocol and selected eye (A). Main Window, Calibration Mode, Monocular VNG E. Click F12 Start. The system automatically adjusts the gain and offset of the eye signal to match the target. When the two tracings match (in size), press F12 Accept and allow 2 to 3 more cycles to run to verify the accuracy of the calibration. Accept Calibration Marker (A) VNG Note: The Video Eye Display dialog will display Calibration Waveforms Otometrics - ICS Chartr 200 VNG/ENG 23

4 Collect Patient Data F. Click F12 Stop. Note The system accepts the calibration or displays this error message: Click OK to calibrate the system before running the selected test. Then press F4 Resume and repeat D through F. Click Use Default Calibration to calibrate the system using the default calibration (applies only to this test). Then press F4 Resume and repeat D through F. Technical Comment G. Use F5 Enlarge and F6 Shrink to adjust the calibration if you are unable to recalibrate or recollect data. Enlarge will increase the size of the waveform, and Shrink will reduce it. These adjustments will apply only to this test. Press F3 Original Calibration to remove the adjustments. H. Click F12 Save to save the calibration. I. Click F10 Next Channel or F11 Previous Channel to calibrate a different channel. J. Click F9 Done to return to the test mode. K. Go to Step 19 Start Data Collection 25. 24 Otometrics - ICS Chartr 200 VNG/ENG

4 Collect Patient Data 4.6 Step 19 Start Data Collection The operator may start and stop data collection at any time. A test may be repeated and saved. The first test is designated as primary, the others are secondary. Primary test results will be included in the patient report (see Step 32 Print the Report 46) and the primary designation may be reassigned during a review (see Step 22 Reassign Primary Test Status 29). The suggested minimum collection time is 1 minute 30 seconds for Saccade and Tracking tests and approximately 2 minutes for Caloric tests. Other tests should be run for 20 seconds or longer, if needed. If your system uses a GN Otometrics caloric stimulator, you may use the caloric handset or footswitch to start a test. Selecting a caloric test on the New Test tab automatically selects the cool or warm temperature on the stimulator. ENG Note: After a test is started, press the handset or footswitch to remotely center a tracing. VNG Note: After a test is started, press the handset or footswitch to remotely start or restart the video recording. A. Click on a protocol on the New Test tab. B. Click F12 Start to begin data collection. C. Use the function keys during data collection. Function Keys, During Data Collection F2 Event F3 Eyes Open F4 Vision Denied F5 Center F7 Hide Wave F8 Show Wave F9 Cancel Test F10 Overlap Waves F11 Spread Waves F12 Stop/Save Place an Event (E) marker on the tracing. Place an Eyes Open (EO) marker on the tracing. Place a Vision Denied (VD) marker on the tracing. Move the tracing to the center of the waveform area. Display the selected wave. Do not display the selected wave. Stop data collection without saving test results. Stack (overlap) tracings in the waveform area. Spread all tracings evenly in the waveform area. Stop the test./stop data collection and save the results. VNG Note: Go to Step 20 VNG Record Video Image 26 to record eye images during data collection. D. Press F12 Stop. E. Press F12 Save to save the collected data and advance to the next protocol. F. Repeat A through E for each protocol. G. VNG: go to Step 20 VNG Record Video Image 26. ENG: go to Step 21 Display Collected Data 28. Otometrics - ICS Chartr 200 VNG/ENG 25

4 Collect Patient Data 4.7 Step 20 VNG Record Video Image ICS Chartr 200 VNG/ENG records up to 2 minutes of eye movement video for each test and saves the recording with the patient record. A small camera icon next to a patient name in the Patient Selection dialog or protocol in the Review tab indicates the existence of a video recording. Video recording may be started at any time during data collection. The video controls are in the Video Recording Control dialog. A. Click the New Test tab and select a protocol. B. Click F12 Start to begin data collection and display the Video Recording Control dialog. C. Click the Record button to start the video recording. Note You may also use the optional footswitch to start or restart a video recording. 1. Click the Record button (A). Note The system puts an event marker (V) on the tracing at the point video recording begins. Video Recording Control Dialog Box, Both Eyes 2. Note available recording time (B). 1. Click the Record button (A). Note The system puts an event marker (V) on the tracing at the point video recording begins. Video Recording Control Dialog Box, One Eye 2. Note available recording time (B). 26 Otometrics - ICS Chartr 200 VNG/ENG

4 Collect Patient Data D. Monitor video collection activity. 1. Monitor right and left eye movement (A). 2. Monitor remaining time (B). Click Restart button to discard any recorded video and to begin video recording. Click Stop recording video. button to stop Video Recording Control Dialog Box (Recording) E. Click the Stop button. F. Click F12 Save to save the collected data and video recording. G. Go to Step 21 Display Collected Data 28. Otometrics - ICS Chartr 200 VNG/ENG 27

5 Review and Analyze Collected Data 5 Review and Analyze Collected Data 5.1 Step 21 Display Collected Data A. Click the Review tab. B. Select a Physician Order date and Session. 1. Click the q and select a date. 2. Expand a session (A). 3. Click on a protocol to select it (B). Click a + sign to expand a list. Click a sign to collapse a list. Bold text indicates primary status (results will be included in the patient report). To change the status, go to Step 22 Reassign Primary Test Status 29. Review Tab C. Go to Step 23 Reposition Waveforms 30. 28 Otometrics - ICS Chartr 200 VNG/ENG

5 Review and Analyze Collected Data 5.2 Step 22 Reassign Primary Test Status When a test is run more than once during a test session, the system assigns primary status to the first test run and secondary status to the others. Only primary test results are included in the patient report and only the four bolded caloric tests are included in the caloric summary display and the calculations. A. Select the Review tab and click on a secondary (not bold) protocol. B. Select Test > Assign Primary from the Menu bar. C. Make sure the protocol is now bold text. Repeat A and B, if needed. D. Go to Step 23 Reposition Waveforms 30. Otometrics - ICS Chartr 200 VNG/ENG 29

5 Review and Analyze Collected Data 5.3 Step 23 Reposition Waveforms During review, you may view and manipulate collected waveforms. A. Select and move a waveform. 1. Use the scroll bar to view the entire waveform (A). 2. Click on a waveform handle (B). 3. Click and drag (or press the äã keys) to move selected waveforms up or down. The letter on Waveform Handle indicates the channel: Waveform Display Area H V ST HR HL VR VL Horizontal Vertical Stimulus Horizontal Right Horizontal Left Vertical Right Vertical Left A gray handle indicates data was collected for the channel but not displayed. Displayed Time indicates the time for the section of waveform displayed on the screen (A). Information Area During Collection B. Go to Step 32 Print the Report 46 to print a waveform or group of waveforms. C. Go to Step 24 Review a Calibration 31. 30 Otometrics - ICS Chartr 200 VNG/ENG

5 Review and Analyze Collected Data 5.4 Step 24 Review a Calibration A. Click on a test on the Review tab. B. Press F8 Review Calib. The calibration data is saved with a test and can be reviewed. Each calibration record contains the last 10 seconds of the calibration. The age (calculated from the end of the calibration to the beginning of the test) displays in the Main Window Information Area (ENG only). (A) Indicates when operator accepted the calibration. Saved Calibration C. Use the function keys to work with the calibration waveforms. Function Keys, Calibration Review F3 Original Calib. F5 Enlarge F6 Shrink F7 Up F8 Down F9 Close F12 Save Return to the original calibration. Increase the gain of the waveform. Reduce the gain of the waveform. Move selected wave up. Move selected wave down. Close any adjustments. Save calibration and return to test data. D. Go to Step 25 Analyze Saccade Test Results 32, Step 26 Analyze Sinusoidal Tracking 34, Step 27 Analyze Slow Phase Velocity (SPV) Measurements 36 or Step 28 Analyze Caloric Test Results (Pod and Butterfly Views) 39. Otometrics - ICS Chartr 200 VNG/ENG 31

5 Review and Analyze Collected Data 5.5 Step 25 Analyze Saccade Test Results A. Click the Review tab and select a Saccade test. B. Click F12 Analysis. C. Select Analysis > Averaged, Raw, or Averaged & Raw to see different views of the data. 1. Click an option to select it (A). Analysis Menu D. Use the function keys to work with the results. Function Keys, during Saccade Review and Analysis F2 Reanalyze F3 Delete Analysis F5 Enlarge F6 Shrink F7 Up F8 Down F9 Close F10 Previous Saccade F11 Next Saccade F12 Save Discard the current results. Remove the outlined saccade. Increase the gain of a tracing in relation to the target. Reduce the gain of a tracing in relation to the target. Move selected wave up. Move selected wave down. Close Analysis Move to previous saccade. Move to next saccade. Save analysis and return to Review mode. 32 Otometrics - ICS Chartr 200 VNG/ENG

5 Review and Analyze Collected Data Click on a data point (A) to move the tracing (B) to correspond with the analysis result. Amplitude eye movement (in degrees) between the initial position and the first stop. Accuracy amplitude of a saccade divided by the amplitude of target movement; expressed as a percent. Peak Velocity maximum velocity reached in a saccadic movement. Latency time between stimulus movement and the first eye movement Saccade Analysis, Raw and Averaged Values The shaded area is the abnormal area. Notes: The saccade being examined corresponds with the outlined data point ( ) in the Velocity, Accuracy, and Latency windows. Use the waveform handle on the Amplitude chart to move the waveform up or down. The shaded areas on the Peak Velocity, Accuracy, and Latency charts represent normative data. Use this information to compare the averaged responses. E. Click F12 Save to save the analysis. F. Go to Step 26 Analyze Sinusoidal Tracking 34, Step 27 Analyze Slow Phase Velocity (SPV) Measurements 36 or Step 28 Analyze Caloric Test Results (Pod and Butterfly Views) 39. Otometrics - ICS Chartr 200 VNG/ENG 33

5 Review and Analyze Collected Data 5.6 Step 26 Analyze Sinusoidal Tracking A. Click the Review tab and select a Tracking test. B. Click F12 Analysis. C. Select Analysis > Averaged, Raw, or Averaged & Raw to see different views of the data. Click an option to select it (A). Analysis Menu D. Use the function key options to work with the results: Function Keys during Tracking Review and Analysis F2 Reanalyze F3 Delete Analysis F5 Enlarge F6 Shrink F7 Up F8 Down F9 Close F10 Previous Cycle F11 Next Cycle F12 Save Discard the current results. Remove the outlined cycle. Increase the gain of a tracing in relation to the target Reduce the gain of a tracing in relation to the target. Move selected wave up. Move selected wave down. Close Analysis Move to previous cycle. Move to next cycle. Save analysis and return to Review mode. 34 Otometrics - ICS Chartr 200 VNG/ENG

5 Review and Analyze Collected Data 1. Click on a data point (A) to move the tracing (B) to correspond with the analysis result. The shaded area on the Tracking Gain chart represents normative data. Use this information to compare the averaged responses. The shaded area is the abnormal area. Sinusoidal Tracking Analysis, Raw and Averaged Values E. Click F12 Save. F. Go to Step 28 Analyze Caloric Test Results (Pod and Butterfly Views) 39. Otometrics - ICS Chartr 200 VNG/ENG 35

5 Review and Analyze Collected Data 5.7 Step 27 Analyze Slow Phase Velocity (SPV) Measurements A. Click the Review tab and select a Caloric or other test to analyze nystagmus. B. Press F12 Begin to measure the slow phases and plot them on the lower chart. The number of beats analyzed displays in the Information area. C. Use the function keys to work with the results: Function Keys, during SPV Analysis F2 Reanalyze F4 Pods - Butterfly F5 Locate Peak Clear previous analysis and begin a new analysis. Display pod (summary) and butterfly view of caloric analysis. Identifies the second in time with the fastest average value. F6 Set Peak Computes the average of the highest SPVs in the 10- second window at the current cursor location. F7 Delete F8 Insert F9 Close F10 Previous Beat F11 Next Beat F12 Save D. (Optional) Measure the slope of a beat manually. Delete the SPV beat measurement. Accept a new SPV value for the beat. Close Analysis Move to previous beat. Move to next beat. Save analysis and return to Review mode. SPV Analysis 1. Select a beat (A): Click and drag the scroll bar or press the áâarrow keys to move through the tracing (B). Click F10 Previous Beat and F11 Next Beat to move through the tracing. Click on a beat in the lower chart or click in the upper chart to move to that section on the tracing. 2. Click F7 Delete to delete artifactual beats 36 Otometrics - ICS Chartr 200 VNG/ENG

5 Review and Analyze Collected Data Note The vertical cursor represents the same point in time as the vertical cursor in the lower chart and exactly bisects the slow phase of the nystagmus being measured. Measuring SPV Vertical cursor (A). 3. Adjust the slope of the velocity measuring line to measure the slow phase of a beat: Press the ãäarrow keys to raise and lower the line Press Ctrl +á and Ctrl +â to change the angle of the line. Press F8 Insert to enter the new SPV value. Caloric Peak values are represented as: RC = Right Cool LC = Left Cool RW = Right Warm LW = Left Warm FI = Fixation Index SPV Analysis with Peak Selected Otometrics - ICS Chartr 200 VNG/ENG 37

5 Review and Analyze Collected Data Caloric peak values in Information Area E. Press F12 Save to save the analysis. F. Go to Step 28 Analyze Caloric Test Results (Pod and Butterfly Views) 39. 38 Otometrics - ICS Chartr 200 VNG/ENG

5 Review and Analyze Collected Data 5.8 Step 28 Analyze Caloric Test Results (Pod and Butterfly Views) When analyzing caloric test results, the system calculates the caloric unilateral weakness and gain asymmetry. The results are shown in Pods and Butterfly views. A. Click the Review tab and select a Caloric test. B. Click F12 Analysis. C. Click F4 PODS - Butterfly to display the Pods and Butterfly views. Caloric Test Results, Pods and Butterfly Views Pods view displays a plot of individual beats (SPV (degrees/second) / time (seconds)). Caloric weakness and gain asymmetry data display in the Information Area. Gain asymmetry is shown if the option is selected in the Operator Settings/Test Battery tab. Butterfly view two intersecting lines represent cool and warm stimulations. Vertical axis = slow phase velocity Horizontal axis = percent of caloric weakness The lines are connections between the values of the peak responses from right ear caloric stimulations plotted on the left edge and the left ear responses plotted on the right edge. A normal response is an intersection point within the normal box (A). D. Adjust the baseline in the Pods view, if needed. 1. Press F5 Move Baseline Up and F6 Move Baseline Down to move the baseline on the tracing. 2. Press F7 Set Baseline Shift to set a new baseline. Caloric test results, Pods View Otometrics - ICS Chartr 200 VNG/ENG 39

5 Review and Analyze Collected Data Function Keys during Pods review F1 Help F3 Interpret Tests F4 SPV Graph F5 Move Baseline Up F6 Move Baseline Down F7 Set Baseline F9 Close F12 Done Run Interpretation Assistant. Go to SPV Analysis view Move the green baseline up on the tracing. Move the green baseline down on the tracing Accept the new baseline position Close this analysis. Save changes. E. Go to Step 29 Interpretation Assistant 41. 40 Otometrics - ICS Chartr 200 VNG/ENG

5 Review and Analyze Collected Data 5.9 Step 29 Interpretation Assistant The Interpretation Assistant, a software tool provided with some systems, provides suggestions as to the validity and clinical significance of VNG/ENG test results. Currently, this tool works with the results from caloric and static position tests. A. Perform four caloric tests or one or more static position test. B. Select the Review tab and analyze each test. Save the results. C. For caloric tests, click F4 PODS - Butterfly, then click F3 Interpret Tests to view the analysis. 1. Click Paste to Report to copy the results into the patient report. 2. Click OK to close the dialog and exit the Interpretation Assistant. Caloric Test Interpretation Dialog; results within normal range 1. Review results and resolve any technical errors. 2. If no technical errors are found, click Paste To Report to copy the results into the patient report. 3. Click OK to close the dialog and exit the Interpretation Assistant. Caloric Test Interpretation Dialog; results outside of normal values Otometrics - ICS Chartr 200 VNG/ENG 41

5 Review and Analyze Collected Data D. For static positions tests, click F3 Interpret Tests to view the analysis. 1. Select Horizontal or Vertical Nystagmus to generate results for the selected channel. 2. Click Paste to Report to copy the results into the patient report. 3. Click OK to close the dialog and exit the Interpretation Assistant. Static Position Test Interpretation Dialog; results within normal values 1. Select Horizontal or Vertical Nystagmus to generate results for the selected channel. 2. If no technical errors are found, click Paste To Report to copy the results into the patient report. 3. Click OK to close the dialog and exit the Interpretation Assistant. Static Position Test Interpretation Dialog; results outside of normal values E. Go to Step 30 Prepare the Patient Report 43. 42 Otometrics - ICS Chartr 200 VNG/ENG

6 Print a Patient Report 6 Print a Patient Report 6.1 Step 30 Prepare the Patient Report Patient reports consist of patient information and graphic representations of test results. The operator selects test results that will be included in the printed report and may enter his/her impression of the results in the word processor. A. Click F6 Report to open the word processor. B. Review the patient report and complete the results section. 1. Place the cursor in the report and make changes as needed. 2. Click File and select Save to save the changes and return to the Main Window. The system places the Facility and Report Header information in the patient report. See Step 33 Print Waveforms 47. Patient Report in the Word Processor C. Select File > Save on the Menu bar. D. Go to Step 31 Set Report Options 44. Otometrics - ICS Chartr 200 VNG/ENG 43

6 Print a Patient Report 6.2 Step 31 Set Report Options Each operator should plan and designate how the test results (waveforms) will appear in a printed report. The report template is saved with the operator information and used each time the operator prints a report. A. Select Setup > Report from the Main Window to display the Report Setup dialog. 1. Click on a procedure 2. Click Edit. Saccade, Tracking, and Caloric test result printouts are fixed and cannot be modified by the operator. Report Setup Dialog Box B. Click Edit to display the Report Page Setup dialog. 44 Otometrics - ICS Chartr 200 VNG/ENG

6 Print a Patient Report C. Select the location on the page for each protocol in the report. Highlight indicates selected position (A). 1. Select a protocol. 2. Click a button. 3. Click OK. Select move selected protocol to highlighted box. Deselect remove protocol from highlighted box. New Page add a new page to the report. Clear Page remove all protocols from this page. Defaults load the system suggested page layout for this procedure. Move from one report page to another (B). Report Page Setup Dialog Box D. Click OK to save the report page setup. E. Go to Step 32 Print the Report 46. Otometrics - ICS Chartr 200 VNG/ENG 45

6 Print a Patient Report 6.3 Step 32 Print the Report Select the items (patient data, test results, and/or clinical information) you want to include in the printed report. Reports print on Letter or A4 size paper. A. Select File > Print Report to display the Print Report dialog. B. Select the items to include in the report. Print Report Dialog Box 1. Select options to include in the report (A). A ü or means an option is selected. 2. Select to print Raw, Averaged, or Raw and Averaged views of Saccade and Tracking analysis data in the report. 3. Select to include data from this session or all sessions for this patient in the report (B). 4. Select Print Page numbers on the report. 5. Click Print. Click Preview to view the report online. C. Click Print to send the report to the printer. 46 Otometrics - ICS Chartr 200 VNG/ENG

6 Print a Patient Report 6.4 Step 33 Print Waveforms When reviewing or analyzing results, an individual waveform may be printed or several waveforms may be formed into a temporary report and printed. Note This report will not be saved with the patient record. To print a selected waveform, select File > Print Waveform or File > Print Analysis on the menu bar. To create and print a temporary waveform report: A. Click the Review tab, select a protocol, then select a waveform. B. Click F9 Copy Waveform to display the Custom Page dialog. Selected waveform displays here (A). 1. Click on a Display Area to select it (B). 2. Click Paste to copy the waveform to the selected display area. 3. Click Done. Custom Page Dialog Box C. Repeat B to include additional waveforms. D. Click Print to print the waveforms, then click Done to close the dialog. E. Go to Step 23 Reposition Waveforms 30. Otometrics - ICS Chartr 200 VNG/ENG 47

7 System Options and Settings 7 System Options and Settings 7.1 Step 34 Set Up or Edit the Test Site Facility Information Add the test site facility information to the database. The name of the practice or clinic and the title of the report are included on the word processor report page. A. Select Edit > System Options / Workstation Settings Tab. B. Type the test site facility information. 1. Select the Workstation Settings Tab 2. Type the requested information: Practice Name Street Address City State, Zip Code (postal code), Country Phone number Fax number Email address 3. Report Header. Type the information that will appear at the top of the report. 4. Click OK System Options, Workstation Settings Tab / Facility Information C. Click OK to save the information. D. Go to Step 30 Prepare the Patient Report 43. 48 Otometrics - ICS Chartr 200 VNG/ENG

7 System Options and Settings 7.2 Step 35 Modify Workstation and Goggle Settings Use this procedure to modify workstation settings or change the goggle settings. These changes are not operator specific. A. Select Edit > System Options / Workstation Settings Tab. B. Select the Workstation Settings. System Options, Workstation Settings Tab 1. Select the Workstation Settings Tab 2. Type the Workstation Name. 3. Select the Window Size. 4. Select Show Database Size Warning at Startup option. 5. Select Order Tests in Review Tab by Test Date/Time. 6. Select Video Settings : Goggle Model ( See goggle label for #) Fixation Light : Left Eye /Right Eye Type the maximum video recording time in seconds (from 10 to 300 seconds) 7. Select Startup and Warning Options: Normal Suppress Diagnostic Mode 8. Click OK. A means an option is selected. C. Go to Step 36 Peak Frequency/GDT Interface 50 to select Peak Frequency/GDT Interface. Go to Step 10 Study the Main Window 14. Otometrics - ICS Chartr 200 VNG/ENG 49

7 System Options and Settings 7.3 Step 36 Peak Frequency/GDT Interface A. Select the Peak Frequency/GDT Interface Tab if you are using an International version of VNG/ENG. 1. Select the Peak Frequency/GDT Interface Tab 2. Select Program Language 3. Select Peak Frequency Calculation: Peak Frequency Calculation Caloric Frequency Butterfly 4. Select the German GDT Interface Settings 5. Select the GDT Local File Transfer Directories for Incoming and Outgoing Messages. 6. Click OK A ü or a means an option is selected. System Options, Peak Frequency / GDT Interface Tab Go to Step 10 Study the Main Window 14. 50 Otometrics - ICS Chartr 200 VNG/ENG

8 Maintenance and Troubleshooting 8 Maintenance and Troubleshooting The maintenance and troubleshooting information in this section includes: Cleaning and Maintenance Diagnostic System Test Database Repair Utility A method for attempting to fix a corrupt database. Special Notice: Service and repair of electro-medical equipment should be done by the equipment manufacturer or authorized representatives. The manufacturer reserves the right to disclaim all responsibility for the operating, safety, reliability, and performance of equipment serviced or repaired by other parties. 8.1 Cleaning and Maintenance Although ICS Chartr 200 VNG/ENG equipment does not require preventive maintenance, please observe these guidelines: Disposable articles (such as electrodes) should be disposed of according to local regulations. Proper care and maintenance of the video goggles involves disinfecting the goggle parts that make contact with the patient s skin and cleaning the goggle components. Cleaning and disinfecting should be done before placing the goggles on the patient. Note Follow all of the cleaning procedures in this section to avoid damaging the goggles. Face cushion Clean before placing the goggles on the next patient. To clean: 1. Use a pre-moistened non-alcohol based pad (e.g., AudioWipes) or apply the solution to a soft cloth. 2. Wipe the face cushion, and all areas of the goggles that come in contact with the patient, gently with the pad or cloth until clean. This is done to remove dirt and disinfect the goggles. 3. Dispose of the pad or cloth properly after each use. Dichroic mirror surfaces Improper cleaning may scratch the mirror surfaces. To clean: 1. Wipe the surface gently with the cloth provided with the goggles using a rotary motion until the surface is clean. 2. Repeat step 1 for the other side of the mirror. Video camera lenses The camera lenses rarely require cleaning since they are protected within the goggle housing. Never dry-wipe an optical surface as the coating can be easily scratched if improperly cleaned. To clean: Otometrics - ICS Chartr 200 VNG/ENG 51

8 Maintenance and Troubleshooting 1. Place a drop of lens cleaning solution on a cotton swab. Avoid using excessive amounts of the solution; it can get between the lens components. 2. Wipe the surface gently with the cotton swab using a rotary motion until the surface is clean. Note Lens cleaning solution is available at camera/photography stores. Goggles housing The housing is made of molded PVC material. Never spray or immerse the goggles components with the cleaning solutions. This could contaminate the electronics and/or optics. To clean: 1. Moisten a cloth with a mild detergent and water solution until damp. 2. Wipe the soiled surfaces gently with the damp cloth until clean. 3. Wipe the goggles with a clean damp cloth moistened with plain water. 4. Dry the goggles using a dry cloth. 52 Otometrics - ICS Chartr 200 VNG/ENG

8 Maintenance and Troubleshooting 8.2 Diagnostic System Test This diagnostic test verifies the status of system components. A. Place the electrode lead input end of the patient electrode cable into the test fixture. Plug the test fixture cable into the loopback test fixture port ( ) at the back of the ICS Chartr 200. B. Open a patient record, select a protocol, and press F5 Calibrate. C. Press F12 Start. Target and signal waveforms should overlap. Spread the waveforms to make sure both signals are displayed. Contact your supplier if the target and signal waveforms do not mirror each other. System Test D. Repeat for each channel. E. Press F9 Cancel to exit the calibration mode and end the test. Note If the self-test passes, the problem may reside with the electrodes, the leads, or the patient-electrode junction. 8.3 VNG Check Video Equipment Connections This error message displays if there is a video equipment problem (i.e., loose cable connection between the goggles or the PC). Video Connection Error Messagexw A. Click File > Exit. B. Close all open applications. C. Click the Start button, select the Shut Down option, and click OK. Otometrics - ICS Chartr 200 VNG/ENG 53

8 Maintenance and Troubleshooting D. Power up the computer and double-click the ICS VNG/ENG icon on the Windows desktop to restart the application. E. Make sure cable connections between the goggles and video goggles port on the Chartr 200 box are firmly in place. See the diagrams in the Installation Reference section. F. Contact your supplier if problems persist. 8.4 Database Repair Utility A Database Repair utility provided by GN Otometrics can be used to attempt to fix a corrupt database. Use this utility only if a message prompt, indicating the database is corrupt, displays when an operator is trying to access or save information. GN Otometrics recommends running the Windows ScanDisk utility before using the Database repair utility. Close all open programs, then click Start on Taskbar and select Accessories > System Tools > Disk Cleanup. If this does not solve the problem, it may be necessary to use the Database Repair Utility. Warning Running the Database Repair utility on a database that is not experiencing problems may damage the database. Do not use this utility unless necessary. A. Make sure ICS Chartr 200 VNG/ENG is closed. B. Click Start on the Taskbar and select GN Otometrics > Database Repair to display this prompt. Click Yes to repair the database. The utility will close automatically when the process is done. If you click No, the utility will not start. Database Repair Utility Prompt C. Double-click an ICS VNG/ENG icon to restart the application. If database problems continue, contact your supplier. 54 Otometrics - ICS Chartr 200 VNG/ENG

9 Safety 9 Safety This Installation and Startup Guidecontains information and warnings, which must be followed to ensure the safe performance of ICS Chartr 200 VNG/ENG. Local government rules and regulations, if applicable, should also be followed at all times. 9.1 Symbols Used ICS Chartr 200 Symbols ICS Chartr 200 VNG/ENG is marked with this symbol to indicate compliance with Type BF of the safety standard EN 60601-1. ICS Chartr 200 VNG/ENG is marked with this symbol when it is important that the user refers to associated information given in this manual. ICS Chartr 200 VNG/ENG is CE-marked according to the Medical Devices Directive 93/42/EEC. The switch alternates between On and Stand-by mode. Green the switch is On (pushed in) and the USB connection unit is ready. Blue the switch is in Stand-by mode (pushed in) with no USB connection. Clear the switch is Off (pushed out). The instrument is marked with this symbol to indicate that it is electronic equipment covered by the Directive 200296/EC on waste electrical and electronic equipment (WEEE). ICS Chartr 200 VNG/ENG is marked with this symbol to indicate it is suitable for direct current. Symbols on the ICS Chartr 200 VNG/ENG back panel, see section ICS Chartr 200 Back Panel on ICS Chartr 200 Back Panel 68. Otometrics - ICS Chartr 200 VNG/ENG 55

9 Safety 9.2 Warning Notes ICS Chartr 200 VNG/ENGWarning Notes Equipment connected to the displayed connectors must be certified to relevant EN/IEC safety standards, e.g., EN/IEC 60950. Mains connected equipment except EN/IEC 60601-1 certified equipment must be powered from the Powertronix Isolation Station (X1ATWFHNOC1). Equipment connected to the displayed connectors must be certified to relevant EN/IEC safety standards, e.g., EN/IEC 60950. Mains connected equipment except EN/IEC 60601-1 certified equipment must be powered from the Powertronix Isolation Station (X1ATWFHNOC1). The ICS Chartr 200 should only be connected to power adapter type FW7362M/15 from Friwo. For continued protection against fire hazard, replace fuse with the same type and rating only. Note 1: Note 2: Note 3: Note 4: Note 5: Note 6: Note 7: Note 8: Note 9: Note 10: There are no user-serviceable parts inside the ICS Chartr 200 cabinet. For the sake of safety, and in order not to void the warranty, the cabinets should only be opened and serviced by authorized service personnel. In case of defects, please make a detailed description of the defect(s) and contact your supplier. Do not use a defective instrument. Keep ICS Chartr 200 VNG/ENG away from liquids. Do not allow moisture inside the instrument. Do not use the instrument in the presence of flammable anesthetics (gases). Unwanted noise may occur if ICS Chartr 200 VNG/ENG is exposed to a strong radio field. Such noise may interfere with the process of recording correct measurements. Many types of electrical devices, e.g., mobile telephones, may generate radio fields. We recommend that the use of such devices in the vicinity of ICS Chartr 200 VNG/ENG is restricted as much as possible. It is recommended to install the unit in an environment that minimizes the amount of static electricity. For example, anti-static carpeting is recommended. No parts may be eaten, burnt, or in any way used for purposes other than videonystagmography and electronystagmography testing. ICS Chartr VNG/ENG can be disposed of as normal electronic waste, according to local regulations. For safety reasons, accessories connected to the equipment's outlet fittings must be identical to the type supplied with the system. To comply with EN 60601-1-1, the computer, printer, etc. must be connected to the isolation transformer. Conductive parts with patient connection must not be in contact with other conductive parts at any time. No defibrillators or HF surgical equipment should be applied to the patient when connected to ICS Chartr 200 VNG/ENG at any time. 56 Otometrics - ICS Chartr 200 VNG/ENG