natus Otometrics ICS Chartr 200 VNG/ENG Installation And Startup Manual

ICS Chartr 200 VNG/ENG

Installation and Startup Guide

Doc. No. 7-26-3000-EN/11

Part No. 7-26-30000-EN

Copyrightnotice

© 2015,2019Natus MedicalDenmark ApS.All rights reserved. ® Otometrics, the OtometricsIcon, AURICAL,MADSEN, Otoscan,
ICSand HORTMANN are registered trademarks of Natus MedicalDenmark ApS in the U.S.A.and/or other countries.

Version release date

2019-05-15 (213483)

Technical support

Please contact your supplier.

2

Otometrics - ICS Chartr 200 VNG/ENG

Table of Contents

1 Introduction

2 Prepare System for Data Collection

3 Prepare Patient for Testing

4 Collect Patient Data

5 Review and Analyze Collected Data

6 Print a Patient Report

7 System Options and Settings

8 Maintenance and Troubleshooting

9 Safety

10 Manufacturer

11 Technical Specifications

12 Installation

5

6

15

18

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48

51

55

58

59

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Otometrics - ICS Chartr 200 VNG/ENG

3

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 Introduction

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.

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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 >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

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2.2 Step 2 Start a New Patient Record

A. Complete the patient information.

2 Prepare System for Data Collection

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 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

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

Note• Click New Patient to create another

patient record while an existing patient record is
open.

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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.

3. Click the q and select a Referring Facility. If not

4. (optional) Type information about the referral

Note• If this patient was tested previously, click

New Order to start a new physician order for the
patient.

Patient Information Dialog Box, Physician’s Order Tab

If not listed, click Info and go to Step 8 Add a

Referring Physician ► 13.

listed, click Info and go to Step 9 Add a Referring

Facility ► 13

(Referring Notes). This information will appear in
the patient report.

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

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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.

2 Prepare System for Data Collection

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 Fre-

quency/GDT Interface ► 50 to modify the German interface.

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

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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.

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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.

System Options, Operator Settings/Test Battery Tab

2 Prepare System for Data Collection

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 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 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.

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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.

Click the Default Battery button to use the ICS

System Options, Operator Settings/Test Battery Tab

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.

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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.

2 Prepare System for Data Collection

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

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

3. Click OK.

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.

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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

B. ENG: go to Step 11 ENG – Apply Electrodes ► 15.

VNG: go to Step 13 VNG – Place Goggles on Patient ► 17.

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

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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.

3 Prepare Patient for Testing

Channel Electrode cable

Connections

red – blue

Horizontal both (HB)

Vertical right (VR) orange – white

Vertical left (VL) orange – white

Horizontal right (HR) red – black

Horizontal left (HL) blue – black

Normal Electrode Placement (4 channels)

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.

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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.

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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.

3 Prepare Patient for Testing

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.

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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 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 looks

straight ahead.

18 Otometrics - ICS Chartr 200 VNG/ENG

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.

4 Collect Patient Data

Video Adjustments Dialog Box, One Eye

F. Go to Step 15 VNG – Fine Tune the Video Image ► 20.

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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.

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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 Dialog Box

4 Collect Patient Data

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.

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

E. Go to Step 17 Select a Protocol ► 22.

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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.

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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 cur-

rently selected eye.

4 Collect Patient Data

1. Click F9 Switch Eye to change

the selected eye.

2. View selected protocol and selec-

ted 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.

Calibration Waveforms

Otometrics - ICS Chartr 200 VNG/ENG

Accept Calibration Marker (A)

VNG Note: The Video Eye Display dialog

will display

23

4 Collect Patient Data

F. Click F12 Stop.

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

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.

• 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.

24 Otometrics - ICS Chartr 200 VNG/ENG

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 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.

4 Collect Patient Data

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.

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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

Video Recording Control Dialog Box, One Eye

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.

2. Note available recording time (B).

26 Otometrics - ICS Chartr 200 VNG/ENG

D. Monitor video collection activity.

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.

4 Collect Patient Data

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 button to stop

recording video.

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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

5.2 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.

5 Review and Analyze Collected Data

C. Make sure the protocol is now bold text. Repeat A and B, if needed.

D. Go to Step 23 Reposition Waveforms ► 30.

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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.

Waveform Display Area

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:

H Horizontal

V Vertical

ST Stimulus

HR Horizontal Right

HL Horizontal Left

VR Vertical Right

VL 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

5.4 Step 24 Review a Calibration

A. Click on a test on the Review tab.

B. Press F8 Review Calib.

Saved Calibration

5 Review and Analyze Collected Data

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.

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

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.

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.

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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 Close Analysis

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.

Move to previous saccade.

Move to next saccade.

Save analysis and return to Review mode.

32 Otometrics - ICS Chartr 200 VNG/ENG

Saccade Analysis, Raw and Averaged Values

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 velo-

city reached in a saccadic move­ment.

Latency – time between stimulus

movement and the first eye move­ment

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 Close Analysis

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.

Move to previous cycle.

Move to next cycle.

Save analysis and return to Review mode.

34 Otometrics - ICS Chartr 200 VNG/ENG

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.

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.

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

F6 Set Peak

F7 Delete

F8 Insert

F9 Close Close Analysis

F10 Previous Beat

F11 Next Beat

F12 Save

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.

Computes the average of the highest SPVs in the 10­second window at the current cursor location.

Delete the SPV beat measurement.

Accept a new SPV value for the beat.

Move to previous beat.

Move to next beat.

Save analysis and return to Review mode.

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

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.

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.

Measuring SPV

SPV Analysis with Peak Selected

Caloric Peak values are rep­resented as:

RC = Right Cool

LC = Left Cool

RW = Right Warm

LW = Left Warm

FI = Fixation Index

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.

Pods view – displays a plot of indi-

vidual 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 velo-

city

– Horizontal axis = percent of cal-

oric 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

Caloric Test Results, Pods and Butterfly Views

response is an intersection point within
the “normal” box (A).

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

Caloric test results, Pods View

Otometrics - ICS Chartr 200 VNG/ENG

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.

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

E. Go to Step 29 Interpretation Assistant ► 41.

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.

40 Otometrics - ICS Chartr 200 VNG/ENG

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.

5 Review and Analyze Collected Data

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

Caloric Test Interpretation Dialog; results outside of normal values

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.

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.

Static Position Test Interpretation Dialog; results within normal values

1. Select Horizontal or Ver-

tical Nystagmus to gen-

erate results for the
selected channel.

2. Click Paste to Report to

copy the results into the
patient report.

3. Click OK to close the dia-

log 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.

1. Select Horizontal or Ver-

tical Nystagmus to gen-

erate results for the
selected channel.

2. If no technical errors are

found, click Paste To

Report to copy the res-

ults into the patient
report.

3. Click OK to close the dia-

log and exit the Inter­pretation Assistant.

42 Otometrics - ICS Chartr 200 VNG/ENG

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.

6 Print a Patient Report

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

C. Select the location on the page for each protocol in the report.

6 Print a Patient 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 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 Aver-
aged 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

6.4 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.

6 Print a Patient Report

Selected waveform displays here
(A).

1. Click on a Display Area to

select it (B).

2. Click Paste to copy the wave-

form 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

2. Type the requested information:

3. Report Header. Type the inform-

4. Click OK

Tab

– Practice Name

– Street Address

– City

– State, Zip Code (postal code),

Country

– Phone number

– Fax number

– Email address

ation that will appear at the top of
the report.

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

7.2 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

7 System Options and Settings

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 by

Test Date/Time.

6. Select Video Settings :

– Goggle Model ( See goggle

label for #)

– Fixation Light : Left Eye /Right

Eye

– Type the maximum video record-

ing 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 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.

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

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.

8 Maintenance and Troubleshooting

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

8.2 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.

8 Maintenance and Troubleshooting

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 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 Utility

A Database Repair utility provided by 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.

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 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 sup-

plier.

54 Otometrics - ICS Chartr 200 VNG/ENG

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.

9 Safety

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.

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55

9 Safety

9.2 Warning Notes

ICS Chartr 200 VNG/ENG Warning 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: 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.

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 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.

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 and

electronystagmography 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 the

type 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 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

9 Safety

Note 11: Connection to network or modem components may compromise the safety or effectiveness of this

system. 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 specified

by 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 supply

should be connected to the isolation station. Do not connect any other device to the isolation sta­tion. Connecting other devices to the isolation station can overdrive the isolation station resulting in
a 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 electrical
shock.

Note 18: Otometrics ICS Chartr products are not designed to be used in conjunction with any devices not

approved by Otometrics. Summation of combined unapproved parts could result in increased elec­trical 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 equip­ment.) 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 con­figures a medical system, and is therefore, responsible that the system complies with the require­ments of the system standard IEC 60601-1-1. If in doubt, consult the technical service department or
your local representative.

Note 20: The ICS Chartr 200 needs to be installed and put into service according to the EMC information

provided in this manual. Portable and mobile RF communications equipment can affect medical elec­trical equipment. The ICS Chartr 200 may be interfered with by other equipment with CISPR emis­sion requirements.

Note 21: The use of accessories and cables other than those specified in the Accessories list of this manual

may result in increased emissions or decreased immunity of the ICS Chartr 200.

Otometrics - ICS Chartr 200 VNG/ENG

57

10 Manufacturer

10 Manufacturer

Natus MedicalDenmark ApS
Hoerskaetten 9, 2630 Taastrup
Denmark

[phone]

www.natus.com

10.1 Responsibility of the Manufacturer

The manufacturer is to be considered responsible for effects on safety, reliability, and performance of the equipment only
if:

• All assembly operations, extensions, re-adjustments, modifications or repairs are carried out by the equipment man­ufacturer 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 of
equipment serviced or repaired by other parties.

58 Otometrics - ICS Chartr 200 VNG/ENG

11 Technical Specifications

11.1 ICS Chartr ENG

CMR Ratio

>100 dB at 50/60 Hz

Channel Frequency Response

12 dB/octave low-pass filter with a cutoff frequency of 35 Hz

Input Impedance

Channel 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 isolated

ground, which lowers its input impedance.

11 Technical Specifications

Input Sensitivity

A measurement of eye movement as small as 10 µV can be observed on the PC display. Typical voltage measurement from
a human eye is typically between 100 and 400 µV. A gain of 500 is used to amplify the input signal. Hence, the eye move­ment 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 / 700-350

mA

Output 15V DC / 2A

Otometrics - ICS Chartr 200 VNG/ENG

59

11 Technical Specifications

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 Signals

Coupling DC Response

Resolution 0.1° Typical (Horizontal and Vertical)

Linearity 1% Full Scale Horizontal; 1.2% Full Scale

Sampling Rate Full 60 Hz for All Tests

Eye Tracking ± 30° Horizontal; ± 25° Vertical

Software Windows Graphical User Interface; High Performance Analysis Software; Data-

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

Video Camera Number of cameras 2

from Both Eyes)

Vertical

base Storage of Test Data; Sophisticated Patient and Test Data Management

ness

Outgoing signal Monochrome NTSC

Operation mode Frame synchronized

Image sensor size 1/4" (3.3 x 2.5 mm2active 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 procedures

other than those specified herein may result in hazardous radiation expos­ure

60 Otometrics - ICS Chartr 200 VNG/ENG

11 Technical Specifications

Optimal Stimulus

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

Sensing

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)

Operating Mode

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")

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61

11 Technical Specifications

Patient Interface

Distance pupil to pupil 60 ±8mm

Distance eye to forehead 22 ±3mm

Nose width 30 ±10mm

Horizontal range of viewing angle (visor
open)

Vertical range of viewing angle (visor
open)

Calibration

None Required

Standards

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

±55°

±30°

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 sup­plied in starter kit)

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

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

Snap disposable electrodes, qty 20 8-64-21602

VNG optical cleaning cloth 7590527

AudioWipes 8-62-43002

7590030-3

7590318-24-5

7590318-24-7

62 Otometrics - ICS Chartr 200 VNG/ENG

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

11 Technical Specifications

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

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11 Technical Specifications

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 func­tioning of ICS Chartr 200 VNG/ENG.

Guidance and manufacturer'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 Chartr
200 VNG/ENG should ensure that it is used in such an environment.

Emissions test Compliance Electromagnetic environment - guidance

RF emissions
CISPR 11

RF emissions
CISPR 11

Harmonic emissions
IEC 61000-3-2

Voltage fluc­tuations/flicker
emissions IEC
61000-3-3

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 interference
in nearby electronic equipment.

Class B ICS Chartr 200 VNG/ENG is suitable for use in all environments, including

domestic environments and those directly connected to the public low-

Class A

Complies

voltage power supply network that supplies buildings used for domestic pur­poses.

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11 Technical Specifications

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

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

Immunity test IEC 60601

test level

Electrostatic discharge
(ESD)
IEC 61000-4-2

Electrical fast tran­sient/burst IEC 61000-4­4

Surge IEC 61000-4-5 +/- 1 kV line(s) to line(s)

Voltage dips, short inter­ruptions and voltage
variations on power sup­ply input lines IEC
61000-4-11

Power frequency
(50/60 Hz) magnetic
field
IEC 61000-4-8

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

+/- 2 kV for power supply
lines
+/- 1 kV for input/output
lines

+/- 2 kV line(s) to earth

<5 % UT(>95 % dip in UT)
for 0.5 cycle
40 % UT (60 % dip in UT)
for 5 cycles
70 % UT(30 % dip in UT)
for 25 cycles
<5 % UT(>95 % dip in UT)
for 5 s

3 A/m Swept Magnetic Fields

Compliance level Electromagnetic environment -

guidance

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

+/- 2 kV for power supply
lines
+/- 1 kV for input/output
lines

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

<5 % UT(>95 % dip in UT)
for 0.5 cycle
40 % UT (60 % dip in UT)
for 5 cycles
70 % UT(30 % dip in UT)
for 25 cycles
<5 % UT(>95 % dip in UT)
for 5 s

per AAMI

Floors should be wood, concrete or
ceramic tile. If floors are covered with
synthetic material, the relative humidity
should be at least 30 %.

Mains power quality should be that of a
typical commercial or hospital envir­onment.

Mains power quality should be that of a
typical commercial or hospital envir­onment.

Mains power quality should be that of a
typical commercial or hospital envir­onment.
If the user of the ICS Chartr 200
VNG/ENG requires continued operation
during very long power mains inter­ruptions, it is recommended that the ICS
Chartr 200 VNG/ENGbe powered from an
uninterruptible power supply or battery.

Power frequency magnetic fields should
be at levels characteristic of a typical loc­ation in a typical commercial or hospital
environment.

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65

11 Technical Specifications

Guidance and manufacturer's declaration - electromagnetic immunity - for equipment and systems
that are NOT life-supporting

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

Immunity test IEC 60601

test level

Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3

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

Compliance level Electromagnetic environment -

guidance

3 Vrms Portable and mobile RF com-

munications equipment should be
used no closer to any part of ICS Chartr
200 VNG/ENG, including cables, than
the recommended separation distance
calculated from the equation applic­able to the frequency of the trans­mitter.
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 power
rating of the transmitter in watts (W)
according to the transmitter man­ufacturer and d is the recommended
separation distance in metres (m).

Field strengths from fixed RF trans­mitters, as determined by an elec­tromagnetic site survey,ashould be
less than the compliance level in each
frequency range.
Interference may occur in the vicinity
of equipment marked with this symbol:

b

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

Note 1
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 less
than 3 V/m.The compliance levels in the ISM frequency bands between 150 kHz and 80 MHz and in the frequency range
80 MHz to 2.5 GHz are intended to decrease the likelihood that mobile/portable communications equipment could
cause interference if it is inadvertently brought into patient areas. For this reason, an additional factor of 10/3 is used in
calculating the recommended separation distance for transmitters in these frequency ranges.

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11 Technical Specifications

Recommended separation distances between portable and mobile RF communications equipment
and ICS Chartr 200 VNG/ENG

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

of the ICS Chartr 200VNG/ENG can help prevent electromagnetic interference b y maintaining a minimu m distance between po rtable and mo bile RF com-

munications equipment (transmitters) and the ICS Chartr 200VNG/ENG as recommended below, acco rding to th e maximum output power o f the com-

munications equipment.

Separation distance according to frequency of transmitter
m

Rated maximum output

150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz
power of transmitter
W

Rated maximum output
power of transmitter
W

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 output
power 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 range
80 MHz to 2.5 GHz to decrease the likelihood that mobile/portable communications equipment could cause inter­ference if it is inadvertently brought into patient areas.

Note 4: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and

reflection from structures, objects and people.

150 kHz to 80 MHz

d = 1.17

(V1=3)

80 MHz to 800 MHz
d = 1.17

(E1=7)

800 MHz to 2.5 GHz
d = 1

(E1=7)

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67

12 Installation

12 Installation

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

Note• When ICS Chartr 200 VNG/ENG starts the first time, a Workstation name dialog box displays. Type a name

that identifies the workstation and click OK.

If you need additional information or are experiencing problems, refer to the Maintenance and Troubleshooting ► 51 sec­tion 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 Panel

The 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

68 Otometrics - ICS Chartr 200 VNG/ENG

12.2 Set Up the ICS Chartr 200 VNG/ENG Hardware

The ICS Chartr 200 VNG/ENG hardware cable connections are shown on this diagram.

12 Installation

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

goggles

6. Otometrics caloric stimulator

cable to ICS Chartr 200 or foot­switch

7. USB cable to ICS Chartr 200

8. Light bar cable to port on Chartr

200

Otometrics - ICS Chartr 200 VNG/ENG

9. Patient cable

10. Cable to loopback test fixture

11. ICS Chartr 200 power cord to DC

power supply (AC/DC converter)

12. DC power supply (Friwo FW7362M/15

) cable to hospital grade outlet

13. Powertronix isolation station

(X1ATWFHNOC1) cable to hospital
grade outlet

14. Caloric stimulator power cable to hos-

pital grade outlet

15. Footswitch cable to remote

connector on caloric stim­ulator

16. Printer cable to printer port

on laptop

17. Printer power cable to

Powertronix isolation station

18. Laptop power cable to

Powertronix isolation station

19. Video monitor power cable

to Powertronix isolation sta­tion

20. Video monitor power cable

to Powertronix isolation sta­tion

69

12 Installation

12.3 ICS Chartr 200 Remote Control

The wireless remote control consists of a transmitter and a keypad. The keypad allows the operator to remotely operate
many of the VNG/ENG data collection and video recording activities without using the software function keys.

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

Remote Control Keypad

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.

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12 Installation

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12 Installation

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