EyeSeeCam vHIT Instructions for Use Part 1 March 2019

Table of Contents 1

2

3

Introduction ... 1 1.1

About this manual ... 1

1.2

Intended use ... 1

1.3

Included parts ... 0

1.4

Notes on safety ... 0

Unpacking and installation ... 1 2.1

Unpacking and inspection ... 1

2.2

Markings ... 2

2.3

General warnings and precautions ... 2

Getting started and system setup ... 5 3.1 3.2

3.3

Hardware requirements ... 5 Power ... 5 3.2.1

Maximizing the power supply ... 5

3.2.2

Entering BIOS ... 5

3.2.3

Changing BIOS setting ... 5

3.2.4

Windows Power Setting Setup ... 6

3.2.5

USB mode ... 7

Hardware setup ... 7 3.3.1

Goggle setup ... 7

3.3.2

IR illumination ... 8

3.3.3

Focus adjustment... 9

3.3.4

Calibration laser Adjustment ... 9

3.4

Servicing and maintenance ... 10

3.5

Software setup ... 10 3.5.1

4

Installing EyeSeeCam software ... 10

3.5.2

Uninstalling the EyeSeeCam vHIT software - ... 10

3.5.3

Starting EyeSeeCam from OtoAccess® 1.5 ... 10

3.5.4

Starting EyeSeeCam from OtoAccess® 2.0 ... 11

3.5.5

Backing up files in OtoAccess® ... 11

Test procedures ... 13 4.1

Opening Screen ... 13

4.2

Eye calibrations ... 13

4.3

4.2.1

Prepare the patient ... 13

4.2.2

Adjust the eye/camera ... 14

4.2.3

Calibrate the patient ... 15

Head calibrations ... 17 4.3.1

Prepare Patient ... 17

4.3.2

Start Head calibration ... 17

4.3.3

Calibration report – Head ... 18

4.3.4 4.4

Lateral impulses ... 20 4.4.1

4.5

5

Edit and Default Calibrations ... 19 Training guide ... 20

4.4.2

3D Head Modeling ... 21

4.4.3

Display laser during HIT... 22

4.4.4

Reject Noisy Eye Velocity ... 23

4.4.5

Auto-Stop ... 23

4.4.6

Peak Head Velocity Limits ... 23

4.4.7

Set Normative Threshold Ranges ... 24

4.4.8

Default Settings ... 26

4.4.9

Prepare to test ... 27

4.4.10

Start test ... 28

4.4.11

Impulse counter ... 28

Vertical impulses- RALP/LARP ... 30 4.5.1

Background ... 30

4.5.2

Eye Orientation ... 31

4.5.3

Head Orientation ... 32

4.5.4

Prepare ... 33

4.5.5

Direction/plane guide ... 33

4.5.6

Start test ... 34

4.5.7

Stop ... 34

4.6

Suppression Head Impulse Test (SHIMP) ... 35

4.7

Nystagmus test ... 36

Reports... 37 5.1

5.2

5.3

Report Menu Options ... 37 5.1.1

Select and Edit Traces ... 37

5.1.2

Saccade Numerical Data Tables ... 39

5.1.3

Edit Saccades ... 40

5.1.4

3D wave ... 43

5.1.5

Display ... 44

5.1.6

Maximum time... 45

5.1.7

Mirrored ... 46

5.1.8

Denoise ... 47

Generate reports ... 48 5.2.1

Individual Test Reports ... 48

5.2.2

EyeSeeSix report ... 48

Printing Reports ... 51 5.3.1

De-identify Patient Information ... 51

5.3.2

Print to external printer or PDF ... 51

5.4

Export completed session data ... 52

5.5

Video Recording ... 53

6

7

8

Licensing ... 55 6.1

New Systems ... 55

6.2

Upgrade existing systems ... 55

Maintenance ... 57 7.1

General maintenance procedures ... 57

7.2

How to clean Interacoustics Products ... 57

7.3

Concerning repair ... 57

7.4

Warranty ... 58

Technical information... 59 8.1

Appendix A: Electromagnetic compatibility (EMC) ... 60

1 Introduction About this manual

This manual is valid for the EyeSeeCam system (revision 1.3). The product is manufactured by: Interacoustics A/S Audiometer Allé 1 5500 Middelfart Denmark Tel.: +45 6371 3555 Fax: +45 6371 3522 E-mail: [email protected] It is the purpose of this manual to provide users of the Interacoustics EyeSeeCam module with all the information required to carry out safe and reliable measurements. Dizziness is a frequent symptom in ENT, Neurology, and General Medicine. Part of the clinical examination of dizzy patients is based on the head impulse test (HIT) of the vestibulo-ocular reflex (VOR). Head impulses are movements with small positional amplitude (10-20 degrees) but high acceleration (3.000-6.000 degrees/s2) and high velocity (150-300 degrees/s). When performed clinically with no quantitative analysis, the test only detects the presence of a corrective saccade as an indirect sign of a VOR deficit. The HIT can easily be conducted at the bedside, but it has only a moderate sensitivity (63% in experts and 72% in non-experts). Its specificity is 78% in experts and 64% in non-experts. Sensitivity, however, can be improved to up to 100% when quantitative data of the VOR are obtained during the head impulse. In patients with an acute unilateral vestibular deficit the quantitative HIT is as reliable as the caloric irrigation test. Chronic patients, however, show a pathological caloric result in only 64% of the cases but they were reliably identified by quantitative HIT. Hence, in the acute phase of a vestibular deficit either of these tests is sufficient, but in the chronic phase, which is typical for a vertigo and dizziness outpatient unit, the quantitative HIT is better. EyeSeeCam with its lightweight goggles and the integrated inertial measurement unit (IMU) provides a measurement device for an objective and quantifiable HIT. The mobile setup with a battery-driven laptop ensures that the HIT can be applied at the patient’s bedside and in the emergency room. With it, a doctor can objectively and reliably assess peripheral vestibular function in a few minutes and differentiate peripheral from central vertigo. This video-based HIT is a novel, time-saving and low-cost tool that can be readily applied in all clinical setups, such as in vertigo outpatient units or in emergency rooms.

Intended use

The EyeSeeCam vHIT is used to present information on the performance of the balance system by providing objective measures of eye-velocity response to head-velocity stimulus, showing the VOR gain in the plane of rotation of the head The system is to be used by trained personnel only such as audiologists, ENT surgeons, neurologists, hearing healthcare professionals or personnel with a similar level of education.

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The EyeSeeCam is intended for patient from 5 years and up. The patient must be physically sound as the procedures include some physical stimulation/movement. Patient must be able the see the target without the use of spectacles. Contra indications • • • • • • •

Blindness Broken nose or other face/head trauma Problems with the cervical spine, e.g., neck trauma, acute cervical disc herniation Recent eye surgery Ptosis Excessive eye blinks Excessive eye make up

Included parts

EyeSeeCam – vHIT camera and goggle 1 USB cable EyeSeeCam vHIT Software and manuals CD OtoAccess® Database software CD Tape measure

Notes on safety

Our instruction manuals contain safety notes which follow the ANSI recommendations (American National Standards Institute) for safety notes.

WARNING indicates a hazardous situation which, if not avoided, could result in death or serious injury. CAUTION, used with the safety alert symbol, indicates a hazardous situation which, if not avoided, could result in minor or moderate injury.

NOTICE

NOTICE is used to address practices not related to personal injury.

1 Applied part including the USB cable as according ti IEC 60601-1:2005

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2 Unpacking and installation Unpacking and inspection Check box and contents for damage When the instrument is received please check the shipping box for rough handling and damage. If the box is damaged it should be kept until the contents of the shipment have been checked mechanically and electrically. If the instrument is faulty please contact your local distributor. Keep the shipping material for the carrier’s inspection and insurance claim. Keep carton for future shipment The EyeSeeCam comes in its own shipping carton, which is specially designed for the EyeSeeCam. Please keep this carton. It will be needed if the instrument has to be returned for service. If service is required please contact your local distributor. Inspect before connection Prior to connecting the product it should once more be inspected for damage. All of the cabinet and the accessories should be checked visually for scratches and missing parts. Report immediately any faults Any missing part or malfunction should be reported immediately to the supplier of the instrument together with the invoice, serial number, and a detailed report of the problem. In the back of this manual you will find a "Return Report" where you can describe the problem. Please use "Return Report" Please realize that if the service engineer does not know what problem to look for he may not find it, so using the Return Report will be of great help to us and is your best guarantee that the correction of the problem will be to your satisfaction.

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Markings

The following markings can be found on the instrument: Symbol

Explanation Type B applied parts. Patient applied parts that are not conductive and can be immediately released from the patient. Follow instructions for use

WEEE (EU-directive). This symbol indicates that when the end-user wishes to discard this product, it must be sent to separate collection facilities for recovery and recycling. Failing to do so may endanger the environment. The CE-mark indicates that Interacoustics A/S meets the requirements of Annex II of the Medical Device Directive 93/42/EEC. TÜV Product Service, Identification No. 0123, has approved the quality system. 0123 Year of manufacture.

This product is laser class 1. This means the maximum permissible exposure (MPE) cannot be exceeded when viewing a laser with the naked eye.

General warnings and precautions

This equipment is intended to be connected to other equipment thus forming a Medical Electrical System. External equipment intended for connection to signal input, signal output or other connectors shall comply with the relevant product standard e.g. IEC 60950-1 for IT equipment and the IEC 60601-series for medical electrical equipment. In addition, all such combinations – Medical Electrical Systems – shall comply with the safety requirements stated the general standard IEC 60601-1, edition 3, clause 16. Any equipment not complying with the leakage current requirements in IEC 60601-1 shall be kept outside the patient environment i.e. at least 1.5 m from the patient support or shall be supplied via a separation transformer to reduce the leakage currents. Any person who connects external equipment to signal input, signal output or other connectors has formed a Medical Electrical System and is therefore responsible for the system to comply with the requirements. If in doubt, contact qualified medical technician or your local representative. A Separation Device (isolation device) is needed to isolate the equipment located outside the patient environment from the equipment located inside the patient environment. In particular such a Separation Device is required when a network connection is made. The requirement for the Separation Device is defined in IEC 60601-1, edition 3, clause 16.

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•

The EyeSeeCam in not intended for operation in oxygen rich environment, flammable anesthetics, flammable agents or similar

•

The goggle should not be worn by patients with strong defective vision and abnormal rare blink. Please consult a specialist in such circumstances before using the mask on these types of patients.

•

The system must be switched off before cleaning

•

When used for longer time in environments temperatures above 30 °C the surface temperature of the camera unit can exceed 43 °C (max 44 °C). If this feels uncomfortable for the patient turn off the equipment for a while.

•

The EyeSeeCam system must be serviced at least once a year. The service must include a safety test. No parts can be serviced while in use with the patient.

•

Do not use the equipment if the enclosure is not intact, but have the equipment serviced.

•

Only personnel with proper training (skilled personnel) should operate the system.

•

Proper use of this device depends on careful reading of this manual and all additional instructions and labels

•

Let the system obtain room temperature before turning it on. Extra time for obtaining room temperature may be needed to avoid condensation if the system has been moved from a very cold location to a warmer one. The patients or test persons should not wear any optical utilities such as glasses or contact lenses.

• •

The patients or test persons should not wear makeup around the eyes

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3 Getting started and system setup Hardware requirements

System requirements USB EyeSeeCam systems: Laptop PC: One USB 2 port available Desktop PC: One USB 2 port available Furthermore, Microsoft .Net 2.0 Framework and Windows Installer 3.x should be available. If these programs are not installed on your computer, you will be prompted to install them when running the EyeSeeCam installation. Just click yes when the installer asks you, and they will be installed automatically. Operating System Requirements: Windows®7 (32 & 64 bit). Windows® 8 (32 & 64 bit). Windows® 10 (32 & 64 bit).

Power Maximizing the power supply Eye images in the vHIT user interface can become flickering and unstable if the power supplied to the camera is not maximized. These problems mainly occur in PC systems using chipset technology from INTEL. To maximize the power supply, CPU power saving features must be disabled either in the bios setup or via the software as described below. It is recommended to control the CPU power saving features in the computer’s BIOS rather than via software.

Entering BIOS BIOS setup can be entered by following the instruction on the screen shortly after the system is switched on.

Changing BIOS setting CPU power saving features need to be changed to have maximum power / performance by disabling Speed Step and other power controlling features. See example below - changes into ‘Disabled’ must be applied to the functions inside the red boxes.

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Figure 3.2.3-1 Bios settings

Windows Power Setting Setup It is also necessary to disable Windows’ own power saving features: In control panel -> Power options properties, power manager, set power schemes to maximum performance as shown below:

Figure 3.2.4-1 Power Option properties

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USB mode The EyeSeeCam vHIT camera must only be connected to a USB 2.0 port. If the computer only has USB 3.0 ports the USB 3.0 controller must be disabled so that the ports will work in USB 2.0 mode. To downgrade from USB 3.0 to USB 2.0 please go to the BIOS/Config menu and select “USB”. Set the USB 3.0 controller mode to “Disabled” and press F10 to Save and Exit the BIOS Config menu.

Figure 3.2.5-1 Bios Menu

• • • • •

Hardware setup

Connect the USB cable to the computer Connect the other end of the USB cable to the EyeSeeCam camera Mount the camera on the goggle using the spherical ball-and-socket joint Mount the calibration laser on the bridge of the goggle Connect the computer power supply to a wall outlet, then connect to computer Goggle setup

The vHIT goggle generally has one camera (monocular) fixed at the top side(s) of the mask. The

camera is held in place mechanically with a spherical ball-and-socket joint. The vHIT goggle has two spherical sockets: one for the left and one for the right eye. The spherical joint allows the camera to be moved from the mask and plugged into the spherical socket of the other side. This allows for examining either the left or the right eye, depending on which eye is better suited for examination. This feature is particularly useful in patients with either a glass eye or with a ptosis.

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Figure 3.3.1-1vHIT goggle and ball and socket joint for camera. Calibration laser is placed on the bridge of the goggle.

The vHIT goggle suppports the USB camera that is used to record the eye images. This constitutes the major component of your USB vHIT system. The USB camera uses infrared light (IR), which is not visible to the naked eye. The IR illumination enables sessions to be performed in complete darkness. Although it seems to be dark, the eye images will be displayed as clear and visible images due to the IR-illumination. The USB vHIT goggle functions as free field of view only.

Before using the USB vHIT goggle please consider the following: • • •

The goggle and camera contain sensitive electronic and optical devices. Do not expose the goggle or cameras to mechanical shock Do not expose the goggle to moisture (IPX 0 according to IEC 529) USB vHIT goggle is not to be used around explosive gas.

In addition to the camera, there is a calibration laser in the center providing the visual fixation targets for calibration. The laser projects a luminous dot pattern in front of the head, for example, onto the wall, if the tested subject is sitting in front of the wall, or onto the ceiling, if the tested subject is lying. Just like the camera, this calibration laser can also be removed together with the camera. The calibration laser is connected to the camera by means of a flexible wire.

IR illumination Light Emitting Diodes (LEDs) are positioned at the side of the camera objective lens. The lateral LEDs emit infrared light (IR).

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Focus adjustment The lens of the camera module allows you to focus the image. As eye sockets vary in physical dimension from patient to patient, absolute focus requires adjustment to provide focused images – and focused images are a precondition for stable eye tracking and noise-free data. The eye is in focus if details of the individual patterns in the iris (iral signature) are well visible.

Figure 3.3.3-1 Focus adjustment for camera

Calibration laser Adjustment The calibration laser, in the center of the goggle, has a knob that allows you to align the dots on the wall by slightly rotating the knob until the 5 laser dots are aligned horizontally and vertically. Do not adjust the calibration laser unduly. Adjust only if the dots have gone out of horizontal/vertical alignment.

Figure 3.3.4-1 Calibration laser adjustment

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Servicing and maintenance

The vHIT system must be serviced at least once a year. The service must include a safety test.

Software setup

Installation of OtoAccess® – Please refer to the OtoAccess® manual and documentation. Installation of EyeSeeCam vHIT software - Please refer to the EyeSeeCam installation CD and instruction.

Installing EyeSeeCam software Follow the prompts on the screen to step through the software installation.

Figure 3.5.1-1 Set up Wizard for EyeSeeCam

Uninstalling the EyeSeeCam vHIT software Please refer to the EyeSeeCam installation CD and instruction.

Starting EyeSeeCam from OtoAccess® 1.5 To start EyeSeeCam: 1.

Double Click the OtoAccess® icon on the desktop which will open the OtoAccess® program

2.

Select the instrument (in this example, EyeSeeCam) by double-clicking EyeSeeCam in the Select Instrument box. EyeSeeCam will open in a new window.

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Figure 3.5.3-1 OtoAccess® 1.5 Opening Screen

.

Note See the OtoAccess® Online Manual for more information about the user interface.

Starting EyeSeeCam from OtoAccess® 2.0 Open OtoAccess® and select the tab for EyeSeeCam. Select the instrument module (in this example, EyeSeeCam) by clicking the EyeSeeCam icon in the upper left-hand corner. EyeSeeCam will open in a new window.

Figure 3.5.4-1 OtoAccess® 2.0 Opening Screen

Backing up files in OtoAccess® Please refer to your OtoAccess® manual for the procedures on how to back up your patient files.

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4 Test procedures Opening Screen

The opening screen displays the image of the eye in the upper left hand corner and a Recording menu that allows you to select which test you want to perform.

Figure 3.5.5-1 vHIT User Interface

Eye calibrations

Place the goggle on the patient and select Calibration - Standard. Fasten the goggle strap. This is essential to avoid the artifact “slippage”, e.g. a delayed recording of the eye movement in relation to the head movement. Position the camera cable centered in the back of the head. This is important to avoid touching it during head impulses.

Prepare the patient A click on the Prepare button will display the calibration screen and turn on the red calibration laser dots. In prepare mode you can instruct the patient and use the real-time tracings to monitor eye and head movements and check for noise or artifact before beginning the calibration. Ask the participant if all five appearing laser points are clearly visible. If not, special lenses can be applied to the goggles for short sight correction.

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Figure 4.2.1-1 Calibration Preparation Screen

Adjust the eye/camera Instruct the patient to fixate on the center luminous dot. Optimize pupil detection by focusing and adjusting the camera. The pupil should be centered. To avoid partial occlusion by receding eyelids, participants can be told to open their eyes wide, the eyelids can be torn gently under the rim of the goggles. Align the camera by rotating it in its ball-and-socket joint such that the eye is finally centered in the image. The camera can be rotated in three directions: yaw, pitch, and roll. At one time, however, rotate the camera only in one of these three possible directions. After the eye is centered in one direction, e.g., in the horizontal direction, choose the next rotation direction, e.g., the vertical direction. A possible alignment sequence to center the eye is shown below.

Figure 4.2.2-1 Centering the pupil in the image with a sequence of three camera rotations. Immediately after the goggles are placed on the patient, the eye can assume a position as in the upper left image. From this starting position, the camera first needs to be rotated such that the pupil is centered horizontally.

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