Otometrics ICS Impulse USB Manual de usuario

ICS Impulse USB

User Guide

Doc no.7-50-1490-EN/01

Part no. 7-50-14900-EN

0 4 5 9

Copyrightnotice

No part of this documentation or program may be reproduced, stored in a retrieval system, or transmitted, in any form or

by any means, electronic, mechanical, photocopying, recording, or otherwise, without the prior written consent of Natus

Medical Denmark ApS.

Published in Denmark by Natus Medical Denmark ApS

All information, illustrations, and specifications in this manual are based on the latest productinformation available atthe

time of publication. Natus Medical Denmark ApS reserves the right to make changes at any time without notice.

Versionrelease date

2019-04-29

Technicalsupport

Please contact your supplier.

2 Otometrics - ICS Impulse USB

Table of Contents

1 Your New ICS Impulse System 4

2 Intended use 4

3 Typographical conventions 4

4 System startup and logging in 5

5 Patient data entry/lists 5

6 Preparing for testing 8

7 Adding remarks/adding video recording 17

8 Collecting Head Impulse data 17

9 Monitoring eye and head movement 19

10 Analyzing data for a single test 20

11 Analyzing data for multiple-tests 32

12 Working with reports 34

13 How to record and play back video 38

14 System settings 43

15 Installation and Setup 45

16 Accessories 52

17 Service, cleaning, and maintenance 53

18 Other references 54

19 Standards 54

20 Manufacturer 56

21 Warning notes 56

22 Definition of symbols 58

23 Notes on EMC (Electromagnetic Compatibility) 59

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User Guide

1 Your New ICS Impulse System

Congratulations! You are now the owner of a sophisticated new ICS Impulse system developed in collaboration with Drs.

Ian Curthoys, Michael Halmagyi and others at University of Sydney.

To assist you in getting the most out of the ICS Impulse system, we have included a user guide, online reference manual

and a training video. We hope you find it easy to use and that your use of the incorporated tips and information results in

improved data collection accuracy as it relates to your assessment of vestibular-related disorders, test results, reporting,

and patient information retrieval.

1.1 Device description

ICS Impulse is a monocular video goggle with built-in gyroscopes that allow for the measurement of eye and head move-

ment. The ICS Impulse is operated from the OTOsuiteVestibular software.

• With ICS Impulse you can perform the head impulse test

• With ICS Impulse you can assess the anterior, posterior and lateral semicircular canals

• With ICS Impulse you can video record the eye and the room (using the synchronized room video) and play back the

videos synchronously

2 Intended use

Users: to be used only by qualified medical personnel with prior knowledge of the medical and scientific facts underlying

the procedure.

Use: used in the assessment of patients with complaints of dizziness, disequilibrium, and vertigo. The assessment of the ves-

tibular-ocular reflex (VOR) is performed by measuring, recording, displaying, and analyzing eye and head movements.

3 Typographical conventions

The use of Warning, Caution and Note

For safety reasons and appropriate use of the device and/or software, the manual contains Warnings,Cautions and Notes.

These headings are used as follows:

Warning•Indicates that there is risk of death or serious injury to the user or patient.

Caution•Indicates that there is a risk of injury to the user or patient or risk of damage to data or the device.

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User Guide

Note •Indicates that you should take special notice.

4 System startup and logging in

1. Switch on the computer.

2. Double-click the OTOsuiteVestibular icon.

Note •An Administrator user name and password are provided with a new installation of OTOsuiteVestibular. DO

NOT delete the user name or password from the login screen until at least one new user name with password has been

added. Ensure that at least one user has administrator privileges. For information on how to add new users, refer

toSet up a new user ►43.

At the login screen

Note •Both user name and password are case sensitive.

1. Enter your user name.

2. Enter your password and click OK.

For additional information about the OTOsuiteVestibular screen, entering test remarks, report findings, working with

patients lists, and logging out refer to the Reference Manual.

5 Patient data entry/lists

The Current Patient group provides information about the patient currently open.

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User Guide

• Last name

• First name

• Patient ID

• Date of Birth

• Click Edit to modify patient information

• Click Close to close the current patient and start a new temporary patient

If no patient is open, a temporary patient is available. The temporary patient allows testing to start without entering

patient data. The patient is given a unique number based on the date and time the patient record was created (yyyym-

mddhhmmss where yyyy=year, mm=month, hh=hour, dd-day, mm=minute, and ss=second).

Once data is saved, you will be prompted to edit the temporary patient information. For information about editing existing

patient information, refer to page ►7.

Patients group

This group allows you to create a new patient or view a list of existing patients.

To enter information for a new patient, click New Patient and add patient information in the form:

• Entries that cannot be left blank are marked with an asterisk (*).

• For all entries the maximum number of characters is 45.

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User Guide

• Patient ID can be numeric, alphabetical or a combination of numbers and letters.

• To set the gender, click the down arrow and select the appropriate entry.

• The date of birth format is determined by the computer setup and will display as mm/dd/yyyy or dd/mm/yyyy where

mm=month, dd=day, and yyyy=year. Only numeric characters are allowed (alpha characters can not be used).

Existing patient

A complete description of patient list operations is provided inthe Reference Manual.

From the Patients group, click Patient List. The window that displays provides access to existing patients.

Each row has patient information separated into columns according to the type of information: Patient name, ID#, etc. The

HI (Head Impulse) and Video columns are blank or have check marks to indicate the following:

•HI - head impulse data is saved

•Video - video data is saved

Note •The symbol indicates the user has chosen to mark one or more tests or videos for a specific purpose (for

example, it may refer to abnormal results, results to be used for a study, etc.)

To select a patient, click the patient name.

• Click Open (or double-click) to open the patient to view test results

• Click Edit to make changes to the existing patient information

Modify patient information in this form:

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User Guide

6 Preparing for testing

6.1 The patient is prepared

Warning•A head impulse should not be performed on patients with a neck injury, or on patients who have been told

by their physicians to limit or avoid neck movement activity.

Prior to testing, provide the patient with these general recommendations:

• If in doubt, consult with a physician about the possible side effects of stopping a particular medication.

• Stop tranquilizers, sedatives, or vestibular suppressants for at least 48 hours before the test.

• Continue medications that are vital, such as insulin, heart medications, seizure medications, and possibly anti-

depressants.

• No alcohol for 48 hours before testing.

• Do not wear make-up around the eyes.

• Wear comfortable clothing.

6.2 The goggles are prepared

Observe the recommended guidelines regarding cleaning and maintenance for the goggles as described in Service, clean-

ing, and maintenance ►53.

Note •The single-use, disposable face cushion should be replaced for each new patient.

1. To remove the face cushion, slightly flex the goggles out at the side opposite of the camera side and snap out the face

cushion. Release the face cushion from the other side.

2. Properly dispose of the used face cushion.

3. Obtain a new face cushion.

4. Align the tab of the face cushion with the hole on the camera side of the goggles.

5. Ensure the face cushion is inside the nose piece.

6. Slightly flex the goggles at the opposite side, align the tab of the face cushion with the hole on this side of the goggles.

7. Double check both sides are fully inserted by pressing in at each side.

6.3 Set up a proper test environment

The environment where the patient is tested can vary but must allow you to position the patient at least one meter from

the wall (or other solid surface that can be used as a projection surface.).

1. Choose a wall that allows you to position the patient at least one meter in front of the fixation dot.

2. Apply one of the fixation dots supplied with the system to the wall in a location that allows you to position the patient

directly in front of the fixation dot.

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6.4 Place goggles on patient

When goggles are placed properly they sit comfortably on the bridge of the nose and will not slip during the test. Poor

goggle fit resulting in slippage can result in gain values being inaccurate.

Note •You can find more information in the ICS Impulse training video or at www.icsimpulse.com.

Caution•Goggle Fit is Important. Improper goggle fit can result in inaccurate data collection. Goggle slippage often

results in inaccurate gain values (too high).

After placing the goggle on the patient and tightening the strap, look at how the goggle fits on the person's face. If there

are gaps between the goggle and the patient's face the goggle may slip.

Improper goggle fit

1. Before putting the goggles on the patient ensure

– the goggles have a new unused face cushion. Refer to The goggles are prepared ►8.

– the mirror is clean. Refer to Service, cleaning, and maintenance ►53.

Note •The single-use, disposable face cushion must be replaced for each new patient.

Caution•Improper cleaning may scratch the mirror surfaces.

2. If required, replace the strap. Refer to Service, cleaning, and maintenance ►53.

3. Position the goggles on the patient’s face over the bridge of the nose.

4. Bring the strap above the patient’s ears and around to the back of head.

5. Tighten the strap tight enough to ensure that goggles will not shift during testing.

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User Guide

6. Allowing some flexibility in the cables for head movement during testing, clip the cable clip to the patient’s clothing

at the top of the shoulder.

7. Ensure the eyes are wide open with eyelids positioned to not interfere with pupil detection. If required, adjust the

skin around the eye:

Tilt the bottom of the goggles out and away from the face, pulling the skin below the eye down and repositioning the

goggles to hold the skin in place. Tilt the top of the goggles out and away from the face, pulling the skin above the eye

up and repositioning the goggles to hold the skin in place.

8. Visually inspect goggle fit.

Proper goggle fit

6.5 Adjust system for correct pupil detection and tracking

6.5.1 Lateral test

1. Choose the Impulse Type:Lateral.

2. For patients with spontaneous nystagmus or gaze-evoked nystagmus (evoked by gaze position during head impulse),

select the check box Spontaneous Nystagmus. By selecting this check box for a patient who has spontaneous nys-

tagmus or gaze-evoked nystagmus, it prevents good impulses from being rejected inappropriately.

3. Position the patient at least one meter in front the wall (refer to Preparing for testing ►8for information).

Note •The Center button is disabled when Lateral is the selected Impulse Type.

10 Otometrics - ICS Impulse USB

User Guide

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