Chartr200 VNG-ENG - Installation Guide (EN)

ICS Chartr 200 VNG/ENGInstallation and Startup Guide

Doc. No. 7-26-3000-EN/12Part No. 7-26-30000-EN

Copyright notice© 2015, 2020 Natus Medical Denmark ApS. All rights reserved. ® Otometrics, the Otometrics Icon, AURICAL,MADSEN,HI-PRO 2,Otoscan, ICS and HORTMANN are registered trademarks of Natus Medical Denmark ApS in the U.S.A. and/or other countries.

Version release date2020-01-27 (215921)

Technical supportPlease contact your supplier.

Otometrics - ICS Chartr 200 VNG/ENG2

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

3Otometrics - ICS Chartr 200 VNG/ENG

1 IntroductionICS Chartr 200 VNG/ENG is indicated for videonystagmography and/or electronystagmography testing for patients with acomplaint 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 withstep-by-step instructions for setting up records, preparing the patient, collecting data, reviewing and analyzing data, andpreparing 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 200VNG/ENG system.

1.1 Intended UseThe ICS Chartr 200 VNG/ENG is a nystagmograph that is intended to measure, record, and display involuntary movement(nystagmus) of the eyeball.

Intended user profileUsers of Type 1068 and Type 1086: To be used only by qualified healthcare personnel with prior knowledge of the medicaland scientific facts underlying the procedure.

Otometrics - ICS Chartr 200 VNG/ENG 5

1 Introduction

2 Prepare System for Data Collection

2.1 Step 1 System StartupA. 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 onthe Taskbar. Select Programs >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


2.2 Step 2 Start a New Patient RecordA. Complete the patient information.

Patient Information Dialog Box, Patient Information Tab

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 Num-ber, etc.)

5. Click theq and select the Operator. If your nameis not on the list go to Step 5 Add an Operator10.

Note •Click New Patient to create anotherpatient record while an existing patient record isopen.

B. Go to Step 3 Select a Referring Physician and Facility 8



2.3 Step 3 Select a Referring Physician and FacilityA referring physician can be associated with a patient record. This association is called a Physician Order.

A. Select a Referring Physician and Referring Facility.

Patient Information Dialog Box, Physician’s Order Tab

1. Click the Physician’s Order tab

2. Click theq and select the Referring Physician.If not listed, click Info and go to Step 8 Add aReferring Physician 13.

3. Click theq and select a Referring Facility. If notlisted, click Info and go to Step 9 Add a ReferringFacility 13

4. (optional) Type information about the referral(Referring Notes). This information will appear inthe patient report.

Note • If this patient was tested previously, clickNew Order to start a new physician order for thepatient.

B. Go to Step 4 Answer Clinical Information Questions 9.



2.4 Step 4 Answer Clinical Information QuestionsThe clinical information questions seek information about the patient’s general condition, and eye and ear examinationfindings. This information can be included in the patient report.

A. Click the Clinical Information tab.

B. Click on a button and answer the questions.

Patient Information Dialog Box, Clinical InformationTab

1. Click the Clinical Information tab.

2. Click General and select an option. Click Next tosee another question.

3. Click Eye Movement Examination and select anoption. Click Next to see another question.

4. Click Ear Examination and select an option. ClickNext to see another question.

5. Click the Patient 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 modifyoperator options, and Step 7 Modify the Test Battery 12 to modify the test battery. Go to Step 36 Peak Fre-quency/GDT Interface 50 to modify the German interface.

E. Go to Step 10 Study the Main Window 14.



2.5 Step 5 Add an OperatorA. Select Edit > Operator Info.

B. Complete the operator information.

Edit Operators

1. Click New

2. Type your:



– Address

– City

– State, Zip Code (postal code), Country

– Telephone Number

– Identification (such as a work ID, etc.)

3. Click OK

C. Go to Step 2 Start a New Patient Record 7 or click F2 New Patient.



2.6 Step 6 Modify Operator OptionsEach operator may establish collection, review, and report settings. These settings will be in effect each time the oper-ator’s name is selected.

A. Select Edit > System Options. Select the Operator Settings/Test Battery tab.

B. Customize the Collection, Review, and Report Settings.

System Options, Operator Settings/Test Battery Tab

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. 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 Report4. Select the Operator Specific Settings:

– Require Calibration Before Collection

– Center Tracings Every [x] secs (exceptgaze, saccade, tracking)

– Footswitch/Irrigator Buttons – Centerwaveform during collection

– Display Lightbar Center Fixation Light

– Lightbar Brightness [Low, Medium, High]

– Enable Distance Ranger

– Show Averaged Saccade and Tracking Val-ues

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.



2.7 Step 7 Modify the Test BatteryIn addition to establishing collection, review, and report settings, each operator may create a customized test battery (test-ing 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 hard-ware is not turned on, the Test Battery Lists will be empty because the available protocols are hardware dependent.

System Options, Operator Settings/Test Battery Tab

1. Click the Operator Settings / Test Battery tab.

2. Select an operator. If your name is not on the list, goto Step 5 Add an Operator 10

3. Click on a + to show the protocols listed under a pro-cedure.

4. Click on a protocol or procedure to highlight it.

5. Click the Insert >> button to move the highlightedprotocol to the selected test protocols (test battery)box.

Click the <<Remove removebutton to delete a high-lighted protocol or procedure from the test battery.

Click the Remove All button to delete all of the pro-tocols and procedures from the test battery.

Click the Default Battery button to use the ICSdefault 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 firstinstall the system, you set up a facility default operator test battery. Then add all other operators, and they will inherit thedefault 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.



2.8 Step 8 Add a Referring PhysicianReferring physician records are available to all operators. If the referring physician’s name is not on the list, create a newrecord.

A. Click New to start a new record and type the requested information.

Referring Physician Information Dialog Box

1. Click New.

2. Type the physician’s:



– Address

– City

– Zip Code (postal code)

– Country

– Identification (work ID, etc.)

– Telephone number (up to 5)

– Fax number

– Email address

3. Click OK.

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 FacilityReferring 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 Person3. Click OK.

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 A4 Referring Notes).

2.10 Step 10 Study the Main WindowThe 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 MainWindow.

VNG/ENG Main Window with Patient Data

A. Title barB. Menu barC. ToolbarD. Waveform Display Area

E. Eye image areaF. Function keysG. Status barH. New Test & Review tabs

I. New Test/Review areaJ. Information areaK. Text comments

B. ENG: go to Step 11 ENG – Apply Electrodes 15.VNG: go to Step 13 VNG – Place Goggles on Patient 17.



3 Prepare Patient for Testing

3.1 Step 11 ENG – Apply ElectrodesThe ENG system records 2 or 4 channels of eye movement information. Channel designations relate to electrode place-ment 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 Electrode cableConnections

Normal Electrode Placement (4 channels)

Horizontal both (HB)red – blue

Vertical right (VR) orange – white

Vertical left (VL) orange – white

Horizontal right (HR) red – black

Horizontal left (HL) blue – black

Note •For 2 channel recordings, use the green and brown openings on the patient cable for the vertical chan-nel. 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.



3.2 Step 12 ENG – Check ElectrodesImpedance is measured at each skin-electrode interface. A question mark (?) indicates an unacceptable electrode con-nection.

A. Select a protocol in the New Test tab, then click F7 Electrode Test .

B. Read the status of each active electrode and channel.

Electrode Test Dialog Box

1. Check each electrode connection.

2. Check mV or K Ohm values.

3. Click OK.

C. Reapply electrodes or leads as needed.

D. Click OK to close the dialog.

E. Go to Step 16 Check the Range 21.



3.3 Step 13 VNG – Place Goggles on PatientThe video goggles contain video camera lenses and mirrors. The video image displays on the monitor. For more inform-ation 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 UserManual 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 ofthe skull.) Replace worn head straps. See the User Manual.

VNG Video Goggles

A. Fine focus adjustment knob. Turn this knobto fine tune (focus) the eye images in theVideo Adjustments dialog box. Focus adjust-ment may be needed if the patient has deep-set or protruding eyes.

B. Horizontal positioning knob. Turn knob toadjust the horizontal position of the eyes.Adjustment may be needed if the patient haswide-set or close-set eyes.

C. Vertical positioning knob. Turn knob to adjustthe vertical position of the eyes.

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.



4 Collect Patient Data

4.1 Step 14 VNG – Center and Focus the Video ImageA. 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 centeras possible.

3. Tighten the back head strap until the goggles are snug. The goggles should fit securely so they will not move dur-ing positional testing.

4. Straighten and tighten the top head strap to assist in positioning the goggles on the patient’s face and positioningthe pupils in the box.

Video Adjustments Dialog Box, Both Eyes

5. Use the goggle horizontaland vertical positioningknobs to center each pupilimage.

6. Use the goggle focus knobsto focus each image.

7. Repeat as needed to centerthe pupils and focus the eyeimages.

Note •For monocular testing, only the selected eye will be visible. If testing both eyes, make sure both eye images dis-play, 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 looksstraight ahead.



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.



4.2 Step 15 VNG – Fine Tune the Video ImageA. 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., eye-lashes). 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 ofthe tracking.

Video Adjustments Dialog Box

1. Drag the Threshold (A) sliderslightly up or down until thepupil tracks properly.

2. Select Adjust Both Eyes tochange brightness and con-trast for both eyes at thesame time

3. Drag the Brightness (B) andContrast (C) sliders until theimage is clear and goodtracking is obtained.

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.



4.3 Step 16 Check the RangeA range sensor provides a continuous display of patient-to-light bar distance. The acceptable range during testing is 3 feet 8inches 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 dis-plays 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 Dialog Box

Range:

• Distance – in feet / inches and centimeters

• Over Range

• Under Range

During a test, range status updates every 3 seconds and dis-plays in the Information Area of the Main Window.

D. Click OK to close the dialog and exit the Interpretation Assistant.

E. Go to Step 17 Select a Protocol 22.



4.4 Step 17 Select a ProtocolA. Click the New Test tab on the left side of the Main Window.

New Test Tab

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.

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.



4.5 Step 18 Calibrate the PatientThe horizontal channel should always be calibrated if possible. The vertical channel is more difficult for patients, and it isacceptable 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 withoutmoving 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 cur-rently selected eye.

Main Window, Calibration Mode, Monocular VNG

1. Click F9 Switch Eye to changethe selected eye.

2. View selected protocol and selec-ted eye (A).

E. Click F12 Start. The system automatically adjusts the gain and offset of the eye signal to match the target. When thetwo tracings match (in size), press F12 Accept and allow 2 to 3 more cycles to run to verify the accuracy of the cal-ibration.

Calibration Waveforms

Accept Calibration Marker (A)

VNG Note: The Video Eye Display dialogwill display



F. Click F12 Stop.

Note •The system accepts the calibration or displays this error message:

• Click OK to calibrate the systembefore running the selected test.Then press F4 Resume and repeatD through F.

• Click Use Default Calibration tocalibrate the system using thedefault calibration (applies only tothis test). Then press F4 Resumeand 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 willincrease the size of the waveform, and Shrink will reduce it. These adjustments will apply only to this test. Press F3Original 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.



4.6 Step 19 Start Data CollectionThe operator may start and stop data collection at any time. A test may be repeated and saved. The first test is designatedas primary, the others are secondary. Primary test results will be included in the patient report (see Step 32 Print theReport 46) and the primary designation may be reassigned during a review (see Step 22 Reassign Primary Test Status29).

The suggestedminimum collection time is 1 minute 30 seconds for Saccade and Tracking tests and approximately 2minutes for Caloric tests. Other tests should be run for 20 seconds or longer, if needed.

If your system uses a Otometrics caloric stimulator, you may use the caloric handset or footswitch to start a test. Selectinga 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 Place an Event (E) marker on the tracing.

F3 Eyes Open Place an Eyes Open (EO) marker on the tracing.

F4 Vision Denied Place a Vision Denied (VD) marker on the tracing.

F5 Center Move the tracing to the center of the waveform area.

F7 Hide Wave Display the selected wave.

F8 Show Wave Do not display the selected wave.

F9 Cancel Test Stop data collection without saving test results.

F10 OverlapWaves Stack (overlap) tracings in the waveform area.

F11 SpreadWaves Spread all tracings evenly in the waveform area.

F12 Stop/Save 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.



4.7 Step 20 VNG – Record Video ImageICS Chartr 200 VNG/ENG records up to 2 minutes of eye movement video for each test and saves the recording with thepatient record. A small camera icon next to a patient name in the Patient Selection dialog or protocol in the Reviewtab 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 Controldialog.

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.

Video Recording Control Dialog Box, Both Eyes

1. Click the Record button (A).

Note •The system puts anevent marker (V) on the tracingat the point video recordingbegins.

2. Note available recording time(B).

Video Recording Control Dialog Box, One Eye

1. Click the Record button (A).

Note •The system puts an eventmarker (V) on the tracing at thepoint video recording begins.

2. Note available recording time (B).



D. Monitor video collection activity.

Video Recording Control Dialog Box (Recording)

1. Monitor right and left eye move-ment (A).

2. Monitor remaining time (B).

Click Restart button to discardany recorded video and to beginvideo recording.

Click Stop button to stoprecording video.

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.



5 Review and Analyze Collected Data

5.1 Step 21 Display Collected DataA. Click the Review tab.

B. Select a Physician Order date and Session.

Review Tab

1. Click theq 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 (res-ults will be included in the patientreport). To change the status, go toStep 22 Reassign Primary Test Status 29.

C. Go to Step 23 Reposition Waveforms 30.



5.2 Step 22 Reassign Primary Test StatusWhen a test is run more than once during a test session, the system assigns primary status to the first test run and sec-ondary status to the others. Only primary test results are included in the patient report and only the four bolded calorictests 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.



5.3 Step 23 Reposition WaveformsDuring review, you may view and manipulate collected waveforms.

A. Select and move a waveform.

Waveform Display Area

1. Use the scroll bar to view the entirewaveform (A).

2. Click on a waveform handle (B).

3. Click and drag (or press theäã keys)to move selected waveforms up ordown.

The letter on Waveform Handle indicatesthe channel:

H Horizontal

V Vertical

ST Stimulus

HR Horizontal Right

HL Horizontal Left

VR Vertical Right

VL Vertical Left

A gray handle indicates data was collectedfor the channel but not displayed.

Information Area During Collection

Displayed Time indicates the time forthe section of waveform displayed onthe screen (A).

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.



5.4 Step 24 Review a CalibrationA. Click on a test on the Review tab.

B. Press F8 Review Calib.

Saved Calibration

The calibration data is saved with a testand can be reviewed. Each calibrationrecord contains the last 10 seconds of thecalibration. The age (calculated from theend of the calibration to the beginning ofthe test) displays in the Main WindowInformation Area (ENG only).

(A) Indicates when operator accepted thecalibration.

C. Use the function keys to work with the calibration waveforms.

Function Keys, Calibration Review

F3 Original Calib. Return to the original calibration.

F5 Enlarge Increase the gain of the waveform.

F6 Shrink Reduce the gain of the waveform.

F7 Up Move selected wave up.

F8 Down Move selected wave down.

F9 Close Close any adjustments.

F12 Save Save calibration and return to test data.

D. Go toStep 25 Analyze Saccade Test Results 32,Step 26 Analyze Sinusoidal Tracking 34,Step 27 Analyze Slow Phase Velocity (SPV) Measurements 36 orStep 28 Analyze Caloric Test Results (Pod and Butterfly Views) 39.



5.5 Step 25 Analyze Saccade Test ResultsA. 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.

Analysis Menu

1. Click an option to select it (A).

D. Use the function keys to work with the results.

Function Keys, during Saccade Review and Analysis

F2 Reanalyze Discard the current results.

F3 Delete Analysis Remove the outlined saccade.

F5 Enlarge Increase the gain of a tracing in relation to the target.

F6 Shrink Reduce the gain of a tracing in relation to the target.



F9 Close Close Analysis

F10 Previous Saccade Move to previous saccade.

F11 Next Saccade Move to next saccade.

F12 Save Save analysis and return to Review mode.



Saccade Analysis, Raw and Averaged Values

Click on a data point (A) to movethe tracing (B) to correspond withthe analysis result.

Amplitude – eye movement (indegrees) between the initial pos-ition and the first stop.

Accuracy– amplitude of a saccadedivided by the amplitude of targetmovement; expressed as a per-cent.

Peak Velocity – maximum velo-city reached in a saccadic move-ment.

Latency – time between stimulusmovement and the first eye move-ment

The shaded area is the abnormalarea.

Notes:• The saccade being examined corresponds with the outlined data point ( ) in the Velocity, Accuracy, and Latency win-

dows.

• 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 tocompare 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 orStep 28 Analyze Caloric Test Results (Pod and Butterfly Views) 39.



5.6 Step 26 Analyze Sinusoidal TrackingA. Click the Review tab and select a Tracking test.


C. Select Analysis > Averaged, Raw, or Averaged & Raw to see different views of the data.

Analysis Menu

Click an option to select it (A).

D. Use the function key options to work with the results:

Function Keys during Tracking Review and Analysis

F2 Reanalyze Discard the current results.

F3 Delete Analysis Remove the outlined cycle.

F5 Enlarge Increase the gain of a tracing in relation to the target

F6 Shrink Reduce the gain of a tracing in relation to the target.




F10 Previous Cycle Move to previous cycle.

F11 Next Cycle Move to next cycle.




Sinusoidal Tracking Analysis, Raw and Averaged Values

1. Click on a data point (A) to movethe tracing (B) to correspond withthe analysis result.

The shaded area on the Tracking Gainchart represents normative data. Usethis information to compare the aver-aged responses.

The shaded area is the abnormal area.

E. Click F12 Save.

F. Go to Step 28 Analyze Caloric Test Results (Pod and Butterfly Views) 39.



5.7 Step 27 Analyze Slow Phase Velocity (SPV) MeasurementsA. 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 displaysin the Information area.

C. Use the function keys to work with the results:

Function Keys, during SPV Analysis

F2 Reanalyze Clear previous analysis and begin a new analysis.

F4 Pods - Butterfly Display pod (summary) and butterfly view of caloric ana-lysis.

F5 Locate Peak Identifies the second in time with the fastest averagevalue.

F6 Set Peak Computes the average of the highest SPVs in the 10-second window at the current cursor location.

F7 Delete Delete the SPV beat measurement.

F8 Insert Accept a new SPV value for the beat.


F10 Previous Beat Move to previous beat.

F11 Next Beat Move to next beat.


D. (Optional) Measure the slope of a beat manually.

SPV Analysis

1. Select a beat (A):

– Click and drag the scroll bar orpress theáâarrow keys tomove through the tracing (B).

– Click F10 Previous Beat andF11 Next Beat to movethrough the tracing.

– Click on a beat in the lowerchart or click in the upper chartto move to that section on thetracing.

2. Click F7 Delete to delete artifactualbeats



Note •The vertical cursor represents the same point in time as the vertical cursor in the lower chart and exactlybisects the slow phase of the nystagmus being measured.

Measuring SPV

Vertical cursor (A).

3. Adjust the slope of thevelocity measuring line tomeasure the slow phase ofa beat:

– Press theãäarrowkeys to raise and lowerthe line

– Press Ctrl +á andCtrl +â to change theangle of the line.

– Press F8 Insert toenter the new SPVvalue.

SPV Analysis with Peak Selected

Caloric Peak values are rep-resented as:

RC = Right Cool

LC = Left Cool

RW = Right Warm

LW = Left Warm

FI = Fixation Index



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.



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 resultsare shown in “Pods” and “Butterfly” views.

A. Click the Review tab and select a Caloric test.


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 indi-vidual beats (SPV (degrees/second) /time (seconds)). Caloric weakness andgain asymmetry data display in theInformation Area. Gain asymmetry isshown if the option is selected in theOperator Settings/Test Battery tab.

Butterfly view – two intersecting linesrepresent cool and warm stimulations.

– Vertical axis = slow phase velo-city

– Horizontal axis = percent of cal-oric weakness

The lines are connections between thevalues of the peak responses from rightear caloric stimulations plotted on theleft edge and the left ear responses plot-ted on the right edge. A normalresponse is an intersection point withinthe “normal” box (A).

D. Adjust the baseline in the Pods view, if needed.

Caloric test results, Pods View

1. Press F5 Move BaselineUp and F6 Move BaselineDown to move thebaseline on the tracing.

2. Press F7 Set Baseline Shiftto set a new baseline.



Function Keys during Pods review

F1 Help

F3 Interpret Tests Run Interpretation Assistant.

F4 SPV Graph Go to SPV Analysis view

F5 Move Baseline Up Move the green baseline up on the tracing.

F6 Move Baseline Down Move the green baseline down on the tracing

F7 Set Baseline Accept the new baseline position

F9 Close Close this analysis.

F12 Done Save changes.

E. Go to Step 29 Interpretation Assistant 41.



5.9 Step 29 Interpretation AssistantThe Interpretation Assistant, a software tool provided with some systems, provides suggestions as to the validity and clin-ical 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.

Caloric Test Interpretation Dialog; results within normal range

1. Click Paste to Report to copythe results into the patientreport.

2. Click OK to close the dialogand exit the InterpretationAssistant.

Caloric Test Interpretation Dialog; results outside of normal values

1. Review results and resolveany technical errors.

2. If no technical errors arefound, click Paste To Reportto copy the results into thepatient report.

3. Click OK to close the dialogand exit the InterpretationAssistant.



D. For static positions tests, click F3 Interpret Tests to view the analysis.

1. Select Horizontal or Ver-tical Nystagmus to gen-erate results for theselected channel.

2. Click Paste to Report tocopy the results into thepatient report.

3. Click OK to close the dia-log and exit the Inter-pretation Assistant.

Static Position Test Interpretation Dialog; results within normal values

1. Select Horizontal or Ver-tical Nystagmus to gen-erate results for theselected channel.

2. If no technical errors arefound, click Paste ToReport to copy the res-ults into the patientreport.

3. Click OK to close the dia-log and exit the Inter-pretation Assistant.

Static Position Test Interpretation Dialog; results outside of normal values

E. Go to Step 30 Prepare the Patient Report 43.



6 Print a Patient Report

6.1 Step 30 Prepare the Patient ReportPatient reports consist of patient information and graphic representations of test results. The operator selects test resultsthat 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.

Patient Report in the Word Processor

1. Place the cursor in the reportand make changes as needed.

2. Click File and select Save tosave the changes and returnto the Main Window.

The system places the Facility andReport Header information in thepatient report. See Step 33 PrintWaveforms 47.

C. Select File > Save on the Menu bar.

D. Go to Step 31 Set Report Options 44.



6.2 Step 31 Set Report OptionsEach operator should plan and designate how the test results (waveforms) will appear in a printed report. The report “tem-plate” 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.

Report Setup Dialog Box

1. Click on a procedure

2. Click Edit.

Saccade, Tracking, and Caloric test result printoutsare fixed and cannot be modified by the operator.

B. Click Edit to display the Report Page Setup dialog.



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 high-lighted box.

Deselect – remove protocol from high-lighted box.

New Page – add a new page to thereport.

Clear Page – remove all protocols fromthis page.

Defaults – load the system suggested pagelayout 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.



6.3 Step 32 Print the ReportSelect the items (patient data, test results, and/or clinical information) you want to include in the printed report. Reportsprint 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 inthe report (A).

A ü or means an option isselected.

2. Select to print Raw,Averaged, or Raw and Aver-aged views of Saccade andTracking analysis data in thereport.

3. Select to include data fromthis session or all sessions forthis patient in the report (B).

4. Select Print Page numbers onthe report.

5. Click Print.

Click Preview to view the reportonline.

C. Click Print to send the report to the printer.



6.4 Step 33 Print WaveformsWhen reviewing or analyzing results, an individual waveform may be printed or several waveforms may be formed into atemporary 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.

Custom Page Dialog Box

Selected waveform displays here(A).

1. Click on a Display Area toselect it (B).

2. Click Paste to copy the wave-form to the selected displayarea.

3. Click Done.

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.



7 System Options and Settings

7.1 Step 34 Set Up or Edit the Test Site Facility InformationAdd the test site facility information to the database. The name of the practice or clinic and the title of the report areincluded on the word processor report page.

A. Select Edit > System Options /Workstation Settings Tab.

B. Type the test site facility information.

System Options, Workstation Settings Tab / Facility Information

1. Select the Workstation SettingsTab

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 inform-ation that will appear at the top ofthe report.

4. Click OK

C. Click OK to save the information.

D. Go to Step 30 Prepare the Patient Report 43.



7.2 Step 35 Modify Workstation and Goggle SettingsUse 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 Warn-ing at Startup option.

5. Select Order Tests in Review Tab byTest Date/Time.

6. Select Video Settings :

– Goggle Model ( See gogglelabel for #)

– Fixation Light : Left Eye /RightEye

– Type the maximum video record-ing time in seconds (from 10 to300 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.



7.3 Step 36 Peak Frequency/GDT InterfaceA. Select the Peak Frequency/GDT Interface Tab if you are using an International version of VNG/ENG.

System Options, Peak Frequency / GDT Interface Tab

1. Select the Peak Frequency/GDT Inter-face Tab

2. Select Program Language

3. Select Peak Frequency Calculation:

– Peak Frequency Calculation

– Caloric Frequency Butterfly

4. Select the German GDT Interface Set-tings

5. Select the GDT Local File Transfer Dir-ectories for Incoming and Outgoing Mes-sages.

6. Click OK

A ü or a • means an option is selected.

Go to Step 10 Study the Main Window 14.



8 Maintenance and TroubleshootingThe maintenance and troubleshooting information in this section includes:

• Cleaning andMaintenance

• Diagnostic System Test

• Database Repair UtilityA 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 rep-resentatives. The manufacturer reserves the right to disclaim all responsibility for the operating, safety, reliability, and per-formance of equipment serviced or repaired by other parties.

8.1 Cleaning and MaintenanceAlthough ICS Chartr 200 VNG/ENG equipment does not require preventive maintenance, please observe these guidelines:

• Detachable articles (such as electrodes or VNG face cushions) should be disposed of according to local regulations. Theelectrodes supplied for Chartr ENG are intended for single use. This is in order to prevent cross infection betweenpatients.

• Proper care and maintenance of the video goggles involves disinfecting the goggle parts that make contact with thepatient’s skin and cleaning the goggle components. Cleaning and disinfecting should be done before placing thegoggles on the patient.

Note •Follow all of the cleaning procedures in this section to avoid damaging the goggles.

• Face cushionClean 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 orcloth 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 surfacesImproper 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.


8 Maintenance and Troubleshooting

• Video camera lensesThe camera lenses rarely require cleaning since they are protected within the goggle housing. Never dry-wipe anoptical surface as the coating can be easily scratched if improperly cleaned.

To clean:

1. Place a drop of lens cleaning solution on a cotton swab. Avoid using excessive amounts of the solution; it can getbetween 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 housingThe housing is made of molded PVC material. Never spray or immerse the goggles components with the cleaning solu-tions. 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.



8.2 Diagnostic System TestThis 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 intothe 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.

System Test

Spread the waveforms to makesure both signals are dis-played. Contact your supplierif the target and signal wave-forms do not mirror eachother.

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 ConnectionsThis error message displays if there is a video equipment problem (i.e., loose cable connection between the goggles or thePC).

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.



D. Power up the computer and double-click the ICS VNG/ENG icon on the Windows desktop to restart the applic-ation.

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 UtilityA Database Repair utility provided by Otometrics can be used to attempt to fix a corrupt database. Use this utility only if amessage prompt, indicating the database is corrupt, displays when an operator is trying to access or save information.

Otometrics recommends running the Windows ScanDisk utility before using the Database repair utility. Close all open pro-grams, then click Start on Taskbar and select Accessories > System Tools > Disk Cleanup . If this does not solve theproblem, 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 thedatabase. 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 Otometrics > Database Repair to display this prompt.

Database Repair Utility Prompt

Click Yes to repair the database.

The utility will close automatically when the process isdone.

If you click No, the utility will not start.

C. Double-click an ICS VNG/ENG icon to restart the application. If database problems continue, contact your sup-plier.



9 SafetyThis Installation and Startup Guidecontains information and warnings, which must be followed to ensure the safe per-formance of ICS Chartr 200 VNG/ENG. Local government rules and regulations, if applicable, should also be followed at alltimes.

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 safetystandard EN 60601-1.

ICS Chartr 200 VNG/ENG is marked with this symbol when it is important that the user refers to asso-ciated information given in this manual.

The switch alternates between On and Stand-by mode. Green – the switch is On (pushed in) and theUSB connection unit is ready. Blue – the switch is in Stand-by mode (pushed in) with no USB con-nection. Clear – the switch is Off (pushed out).

The instrument is marked with this symbol to indicate that it is electronic equipment covered by theDirective 2002/96/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 200Back Panel on ICSChartr 200 Back Panel 68.

ICS Chartr 200 Accessories Symbols

ISO 15223-1Symbol5.4.2

Do not reuse.Indicates a medical device that is intended for one use, or for use on a single patient during a singleprocedure.


9 Safety

9.2 Warning Notes

ICS Chartr 200 VNG/ENGWarning Notes

Equipment connected to the displayed connectors must be certified to relevantEN/IEC safety standards, e.g., EN/IEC 60950. Mains connected equipment –except EN/IEC 60601-1 certified equipment – must be powered from the Power-tronix Isolation Station (X1ATWFHNOC1).

Equipment connected to the displayed connectors must be certified to relevantEN/IEC safety standards, e.g., EN/IEC 60950. Mains connected equipment –except EN/IEC 60601-1 certified equipment – must be powered from the Power-tronix Isolation Station (X1ATWFHNOC1).

The ICS Chartr 200 should only be connected to power adapter typeFW7362M/15 from Friwo. For continued protection against fire hazard, replacefuse with the same type and rating only.

Note 1: There are no user-serviceable parts inside the ICS Chartr 200 cabinet. For the sake of safety, and inorder not to void the warranty, the cabinets should only be opened and serviced by authorized ser-vice personnel. In case of defects, please make a detailed description of the defect(s) and contactyour supplier. Do not use a defective instrument.

Note 2: Keep ICS Chartr 200 VNG/ENG away from liquids. Do not allow moisture inside the instrument.

Note 3: Do not use the instrument in the presence of flammable anesthetics (gases).

Note 4: Unwanted noise may occur if ICS Chartr 200 VNG/ENG is exposed to a strong radio field. Such noisemay 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 inthe vicinity of ICS Chartr 200 VNG/ENG is restricted as much as possible.

Note 5: It is recommended to install the unit in an environment that minimizes the amount of static elec-tricity. For example, anti-static carpeting is recommended.

Note 6: No parts may be eaten, burnt, or in any way used for purposes other than videonystagmography andelectronystagmography testing.

Note 7: ICS Chartr VNG/ENG can be disposed of as normal electronic waste, according to local regulations.

Note 8: For safety reasons, accessories connected to the equipment's outlet fittings must be identical to thetype supplied with the system.

Note 9: To comply with EN 60601-1-1, the computer, printer, etc. must be connected to the isolation trans-former.

Note 10: Conductive parts with patient connection must not be in contact with other conductive parts at anytime. No defibrillators or HF surgical equipment should be applied to the patient when connectedto ICS Chartr 200 VNG/ENG at any time.


9 Safety

Note 11: Connection to network or modem components may compromise the safety or effectiveness of thissystem. Use fiber-optic network connections to install the computer on a network.

Note 12: Installation of any third party software (applications, programs, or utilities) other than those specifiedby Otometrics can compromise the safety or effectiveness of this system.

Note 13: The device is disconnected from the mains by pulling the plug from the wall outlet.

Note 14: Avoid accidental contact between connected but unapplied parts (VG-40 video goggle and elec-trodes including connections) and other conductive parts.

Note 15: The Isolation station should be plugged into an outlet. Extension cords or power strips (MSPO)should not be used in combination with the isolation station.

Note 16: Only the ICS Chartr 200 power supply, laptop/computer power supply, and printer power supplyshould be connected to the isolation station. Do not connect any other device to the isolation sta-tion. Connecting other devices to the isolation station can overdrive the isolation station resulting ina blown fuse or damaging the isolation station beyond repair.

Note 17: Do not connect the ICS Chartr 200 system directly to the wall outlets. By not using the isolation sta-tion supplied, you put the patient and operator at risk to be exposed to power surges or electricalshock.

Note 18: Otometrics ICS Chartr products are not designed to be used in conjunction with any devices notapproved by Otometrics. Summation of combined unapproved parts could result in increased elec-trical leakage. All parts of the ICS Chartr 200 are suitable for use within the patient environment.

Note 19: Accessory equipment connected to the analog and digital interfaces must be certified to the respect-ive IEC standards (i.e., IEC 950 for data processing equipment and IEC 60601-1 for medical equip-ment.) Furthermore all configurations shall comply with the system standard IEC 60601-1-1.Everybody who connects additional equipment to the signal input part or signal output part con-figures a medical system, and is therefore, responsible that the system complies with the require-ments of the system standard IEC 60601-1-1. If in doubt, consult the technical service department oryour local representative.

Note 20: The ICS Chartr 200 needs to be installed and put into service according to the EMC informationprovided in this manual. Portable and mobile RF communications equipment can affect medical elec-trical equipment. The ICS Chartr 200 may be interfered with by other equipment with CISPR emis-sion requirements.

Note 21: Do not use a multiple USB hub for connection between the device and the PC.

Note 22: The use of accessories and cables other than those specified in the Accessories list of this manualmay result in increased emissions or decreased immunity of the ICS Chartr 200.


9 Safety

10 ManufacturerNatus Medical Denmark ApSHoerskaetten 9, 2630 TaastrupDenmark

+45 45 75 55 55www.natus.com

10.1 Responsibility of the ManufacturerThe manufacturer is to be considered responsible for effects on safety, reliability, and performance of the equipment onlyif:

• All assembly operations, extensions, re-adjustments, modifications or repairs are carried out by the equipment man-ufacturer or personnel authorized by the manufacturer.

• The electrical installation to which the equipment is connected complies with EN/IEC requirements.

• The equipment is used in accordance with the instructions for use.

The manufacturer reserves the right to disclaim all responsibility for the operating safety, reliability and performance ofequipment serviced or repaired by other parties.


10 Manufacturer

11 Technical Specifications

11.1 ICS Chartr ENG

CMR Ratio>100 dB at 50/60 Hz

Channel Frequency Response12 dB/octave low-pass filter with a cutoff frequency of 35 Hz

Input ImpedanceChannel 1:> 5.5 MΩ

Channel 2, 3, 4:> 8.0 MΩ

Note •Channel 1 electrode input is actually shared between two of the channels and has a reference to isolatedground, which lowers its input impedance.

Input SensitivityA measurement of eye movement as small as 10 µV can be observed on the PC display. Typical voltage measurement froma human eye is typically between 100 and 400 µV. A gain of 500 is used to amplify the input signal. Hence, the eye move-ment seen on the PC screen is usually between 40 mV and 200 mV.

11.2 ICS Chartr 200

Interface

USB 2.0 or 3.0 to PC

Type Identification

ICS Chartr 200 is Type 1068 from Natus Medical Denmark ApS

Power Supply

AC/DC Adapter Type FW7362M/15 from Friwo

Input 100-240 VAC / 50-60 Hz / 700-350mA

Output 15V DC / 2A



Isolation Transformer

Powertronix Isolation Station from Natus Medical Denmark ApS.

AC/DC Adapter

Input Voltage 115 (120) / 230 (240) VAC – 50/60Hz

Input Current 2.7A / 1.35A

Leakage Current < 100-A

Output Voltage 115 (120) / 230 (240) VAC

Output Current 2.6A / 1.3A

System Capabilities

Inputs 2 Eyes/4 Channels; Full Binocular Testing (Simultaneous Collection of Signalsfrom Both Eyes)

Coupling DC Response

Resolution 0.1° Typical (Horizontal and Vertical)

Linearity 1% Full Scale Horizontal; 1.2% Full ScaleVertical

Sampling Rate Full 60 Hz for All Tests

Eye Tracking ± 30° Horizontal; ± 25° Vertical

Software Windows Graphical User Interface; High Performance Analysis Software; Data-base Storage of Test Data; Sophisticated Patient and Test Data Management

Additional Capabilities See-through for External Targets; Vision-denied for Testing in Complete Dark-ness

Video Camera Number of cameras 2

Outgoing signal Monochrome NTSC

Operation mode Frame synchronized

Image sensor size 1/4" (3.3 x 2.5 mm2 active area)

Horizontal resolution 320 pixels

Vertical resolution 240 pixels

Frame rate 60 Hz

Laser/LED Laser/LED product Laser/LED product

Maximum measured LED output 470 μW

Classification standard IEC 60825-1, edition 1.2: 2001

Infrared light wavelength 950nm

Caution•Use of controls or adjustments or performance of proceduresother than those specified herein may result in hazardous radiation expos-ure



Optimal Stimulus

(Including Light Bar) Patient-To-Bar Distance 4 feet (1.2 m) Ultrasonic RangeSensing

Target Position Gaze Targets ± 30°

Pursuit and Saccades ± 16° Computer Controlled

Target Size Less than 1/2° of Arc

Brightness Software Controlled

Optokinetic 6 Targets

Rotation 90° (Horizontal or Vertical)

Other stimulators Designed for connection to caloric stim-ulators.

Weight

ICS Chartr 200 unit 2.7 kg (5 lbs 7 oz)

Lightbar 2.4 kg (5 lbs 3 oz)

Binocular goggles 0.4 kg (14.5 oz)

OperatingMode

Warm-up time: <2 min

Mode of operation: Continuous

Operating Environment

Temperature: +15° C to +35° C (59° F to +95° F)

Rel. Humidity: 30 to 90%, non-condensing

Air Pressure: 600 hPa to 1060 hPa

Operations at temperatures below –20° C (-4° F) or above +60° C (140° F) may cause permanent damage.

Storing and Handling

Temperature: -20° C to +60° C (-4° F to +140° F)

Rel. Humidity: <90%, non-condensing

Air Pressure: 500 hPa to 1060 hPa

Dimensions

ICS Chartr 200 (HxWxD) 4.9 cm x 34.2 cm x 28.7 cm (2" x 13.6" x 11.3")

Lightbar (with ends closed) 11.8 cm x 90.8 cm x 12.1 cm (4.63" x 35.75" x 4.75")



Patient Interface

Distance pupil to pupil 60 ±8mm

Distance eye to forehead 22 ±3mm

Nose width 30 ±10mm

Horizontal range of viewing angle (visoropen)

±55°

Vertical range of viewing angle (visoropen)

±30°

CalibrationNone Required

Standards

Safety: EN 60601-1, UL60601-1, CAN/CSA-C22.2 NO 601.1-M90

ICS Chartr 200: EN 60601-1, Class II, Type BF,IPXO

Power Supply: EN 60601-1, Class II, IPXO

System: EN 60601-1-1

EMC: EN 60601-1-2

Accessories and Cables

Chartr 200 Starter Kit:

Nuprep, 4 oz tubes, pkg/3 (1 tube sup-plied in starter kit)

7590030-3

Five-snap lead package, 24” length (2 chENG)

7590318-24-5

Seven-snap lead package, 24” length (4 chENG)

7590318-24-7

Snap disposable electrodes, qty 20. Singleuse

8-64-21602

VNG optical cleaning cloth 7590527

AudioWipes 8-62-43002



Cables:

Cable, ICS Chartr Lightbar 7-08-10200

ICS Cable, USB type A-B, 3 meters 8-71-79100

Assy, CBL, ICS foot switch 8-35-26400

Power cord, US w/plug (UL approved) 7-08-017

Power cord. CH w/plug 7-08-027

Power cord, EU (straight) 7-08-07500

Power cord, UK (straight) 7-08-07501

Power cord, US (straight) 7-08-07502

Power cord, AUS (straight) 7-08-07503

CD Mains Cord HO5VV, CHI 7-08-07504

Power cable, standard w/ "Schuko" plug 8-71-240

Power cord, DK w/plug 8-71-290

Power cord, UK w/plug 8-71-80200

Power cord, AUS w/plug 8-71-82700

Power cord, CHI w/plug 8-71-86400

Mains Adaptor Cables, EU 7-08-10500

Mains Adaptor Cables, UK 7-08-10501

Mains Adaptor Cables, US 7-08-10502

Mains Adaptor Cables, AUS/CHI 7-08-10503

Mains Adaptor Cables, SWISS 7-08-10505

Mains Adaptor Cables, DK 7-08-10506



11.3 Guidance and manufacturer’s declaration tables• ICS Chartr 200 VNG/ENG is part of a medical electrical system and is thus subject to special safety precautions. For this

reason, the installation and operating instructions provided in this document should be followed closely.

• Portable and mobile high-frequency communication devices, such as mobile phones, may interfere with the func-tioning of ICS Chartr 200 VNG/ENG.

Guidance andmanufacturer's declaration - electromagnetic emissions for all equipment and systems

ICS Chartr 200 VNG/ENG is intended for use in the electromagnetic environment specified below. The user of ICS Chartr200 VNG/ENG should ensure that it is used in such an environment.

Emissions test Compliance Electromagnetic environment - guidance

RF emissionsCISPR11

Group 1 ICS Chartr 200 VNG/ENG uses RF energy only for its internal function. There-fore, its RF emissions are very low and are not likely to cause any interferencein nearby electronic equipment.

RF emissionsCISPR11

Class B ICS Chartr 200 VNG/ENG is suitable for use in all environments, includingdomestic environments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic pur-poses.

Harmonic emissionsIEC 61000-3-2

Class A

Voltage fluc-tuations/flickeremissions IEC61000-3-3

Complies



Guidance andmanufacturer's declaration - electromagnetic immunity for all equipment and systems


Immunity test IEC 60601test level

Compliance level Electromagnetic environment -guidance

Electrostatic discharge(ESD)IEC 61000-4-2

+/- 6 kV contact+/- 8 kV air

+/- 6 kV contact+/- 8 kV air

Floors should be wood, concrete orceramic tile. If floors are covered with syn-thetic material, the relative humidityshould be at least 30 %.

Electrical fast tran-sient/burstIEC 61000-4-4

+/- 2 kV for power supplylines+/- 1 kV for input/outputlines

+/- 2 kV for power supplylines+/- 1 kV for input/outputlines

Mains power quality should be that of atypical commercial or hospital envir-onment.

SurgeIEC 61000-4-5

+/- 1 kV line(s) to line(s)+/- 2 kV line(s) to earth

+/- 1 kV line(s) to line(s)+/- 2 kV line(s) to earth

Mains power quality should be that of atypical commercial or hospital envir-onment.

Voltage dips, shortinterruptions andvoltage variations onpower supply inputlinesIEC 61000-4-11

<5 % UT (>95 % dip in UT)for 0.5 cycle40 % UT (60 % dip in UT)for 5 cycles70 % UT (30 % dip in UT)for 25 cycles<5 % UT (>95 % dip in UT)for 5 s

<5 % UT (>95 % dip in UT)for 0.5 cycle40 % UT (60 % dip in UT)for 5 cycles70 % UT (30 % dip in UT)for 25 cycles<5 % UT (>95 % dip in UT)for 5 s

Mains power quality should be that of atypical commercial or hospital envir-onment.If the user of the ICS Chartr 200 VNG/ENGrequires continued operation during verylong power mains interruptions, it isrecommended that the ICS Chartr 200VNG/ENGbe powered from an unin-terruptible power supply or battery.

Power frequency(50/60 Hz) magneticfieldIEC 61000-4-8

3 A/m Swept Magnetic Fieldsper AAMI

Power frequency magnetic fields shouldbe at levels characteristic of a typical loc-ation in a typical commercial or hospitalenvironment.



Guidance andmanufacturer's declaration - electromagnetic immunity - for equipment and systemsthat are NOT life-supporting


Immunity test IEC 60601test level

Compliance level Electromagnetic environment -guidance

Conducted RFIEC 61000-4-6Radiated RFIEC 61000-4-3

3 Vrms 150 kHz to 80MHz3 V/m 80 MHz to 2,5 GHz

3 Vrms Portable and mobile RF com-munications equipment should beused no closer to any part of ICS Chartr200 VNG/ENG, including cables, thanthe recommended separation distancecalculated from the equation applic-able to the frequency of the trans-mitter.Recommended separation distance:d = 1.17

d = .5 (80 MHz to 800 MHz)d = 1 (80 MHz to 2.5 GHz)

where P is the maximum output powerrating of the transmitter in watts (W)according to the transmitter man-ufacturer and d is the recommendedseparation distance in metres (m).Field strengths from fixed RF trans-mitters, as determined by an elec-tromagnetic site survey, a should beless than the compliance level in eachfrequency range. b

Interference may occur in the vicinityof equipment marked with this symbol:

Note 1: At 80 MHz and 800 MHz the separation distance for the higher frequency range applies.Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflec-tion from structures, objects and people. Over the frequency range 150 kHz to 80 MHz, field strengths should be lessthan 3 V/m.The compliance levels in the ISM frequency bands between 150 kHz and 80 MHz and in the frequency range80 MHz to 2.5 GHz are intended to decrease the likelihood that mobile/portable communications equipment couldcause interference if it is inadvertently brought into patient areas. For this reason, an additional factor of 10/3 is used incalculating the recommended separation distance for transmitters in these frequency ranges.



Recommended separation distances between portable andmobile RF communications equipmentand ICS Chartr 200 VNG/ENG

The ICS Chartr 200VNG/ENG is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user

of the ICS Chartr 200VNG/ENGcan help prevent electromagnetic interference by maintaining aminimum distance between portable and mobile RF com-

munications equipment (transmitters) and the ICS Chartr 200VNG/ENGas recommended below, according to themaximum output power of the com-

munications equipment.

Separation distance according to frequency of transmitterm

Ratedmaximum outputpower of transmitterW

150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz

Rated maximum outputpower of transmitterW

150 kHz to 80 MHzd = 1.17

(V1=3)

80 MHz to 800 MHzd = 1.17

(E1=7)

800 MHz to 2.5 GHzd = 1

(E1=7)

0.01 0.117 0.050 0.10

0.1 0.369 0.158 .316

1 1.167 0.50 1.00

10 3.689 1.58 3.16

100 11.667 5.00 10.00

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters(m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum outputpower rating of the transmitter in watts (W) according to the transmitter manufacturer.

Note 1: At 80 MHz and 800 MHz the separation distance for the higher frequency range applies.

Note 2: The ISM (industrial, scientific and medical) bands between 150 kHz and 80 MHz are 6.765 MHz to 6.795 MHz;13.553 MHz to 13.567 MHz; 26.957 MHz to 27.283 MHz; and 40.66 MHz to 40.70 MHz.

Note 3: An additional factor of 10/3 has been incorporated into the formula used in calculating the recommended sep-aration distance for transmitters in the ISM frequency bands between 150 kHz and 80 MHz and in the frequency range80 MHz to 2.5 GHz to decrease the likelihood that mobile/portable communications equipment could cause inter-ference if it is inadvertently brought into patient areas.

Note 4: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption andreflection from structures, objects and people.



12 InstallationThe Installation section provides equipment setup information for checking the cable connections for the ICS Chartr 200VNG/ENG system.

Note •When ICS Chartr 200 VNG/ENG starts the first time, a Workstation name dialog box displays. Type a namethat identifies the workstation and click OK.

If you need additional information or are experiencing problems, refer to the Maintenance and Troubleshooting 51 sec-tion in this guide.

Warning•Connection of parts other than those supplied for this instrument by Otometrics can degrade the per-formance and safety of the system.

12.1 ICS Chartr 200 Back PanelThe components on theICS Chartr 200 VNG/ENG back panel are shown on the following diagram.

ICS Chartr 200 VNG/ENG Back Panel

1 Audio input 8 PC (laptop)

2 Audio output 9 USB

3 Video output, left 10 Light bar

4 Video output, right 11 Patient cable

5 Video goggles 12 Loopback test fixture

6 Caloric stimulator 13 Power input fuse

7 USB 14 DC power input


12 Installation

12.2 Set Up the ICS Chartr 200 VNG/ENG HardwareThe ICS Chartr 200 VNG/ENG hardware cable connections are shown on this diagram.

ICS Chartr 200 VNG/ENG System Connections

1. Cable to microphone (optional)2. Cable to speaker (optional)3. Monitor cable to left video mon-

itor (optional)4. Monitor cable to right video

monitor (optional)5. Video goggle cable to video

goggles6. Otometrics caloric stimulator

cable to ICS Chartr 200 or foot-switch

7. USB cable to ICS Chartr 2008. Light bar cable to port on Chartr

200

9. Patient cable10. Cable to loopback test fixture11. ICS Chartr 200 power cord to DC

power supply (AC/DC converter)12. DC power supply (Friwo FW7362M/15

) cable to hospital grade outlet13. Powertronix isolation station

(X1ATWFHNOC1) cable to hospitalgrade outlet

14. Caloric stimulator power cable to hos-pital grade outlet

15. Footswitch cable to remoteconnector on caloric stim-ulator

16. Printer cable to printer porton laptop

17. Printer power cable toPowertronix isolation station

18. Laptop power cable toPowertronix isolation station

19. Video monitor power cableto Powertronix isolation sta-tion

20. Video monitor power cableto Powertronix isolation sta-tion


12 Installation

12.3 ICS Chartr 200 Remote ControlThe wireless remote control consists of a transmitter and a keypad. The keypad allows the operator to remotely operatemany of the VNG/ENG data collection and video recording activities without using the software function keys.

Remote Control Keypad

Description / Function

1 Stop video recording

2 Start / restart video recording

3 Turn fixation light on or off

4 Start data collection

5 Save the results

6 Center / calibrate

7 Accept results

8 Stop data collection

9 OK

10 New Test tab / Review tab

11 Next test

12 Previous test

13 Electrode impedance / video adjust / auto adjust

14 Event marker

15 Eyes open marker

16 Vision denied marker

Note •Refer to the User Manual for more information on using the remote control.

Step1Dummy numberused for steps in otherprojects









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12 Installation

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Documents

Chartr200 VNG-ENG - Installation Guide (EN)