ICS Chartr 200 VG40 Video Goggle User Manual Rev 02 Sept 2011

Copyright notice No part of this Manual 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 GN Otometrics A/S. Copyright© 2011, GN Otometrics A/S Printed in Denmark by GN Otometrics A/S, Denmark All information, illustrations, and specifications in this manual are based on the latest product information available at the time of publication. GN Otometrics A/S reserves the right to make changes at any time without notice. Version release date 6. September 2011 Technical support Please contact your supplier.

FM template version: 01-02-2010

Table of Contents VG40 Video Goggle User Manual 1

General Notes and Connecting the Device... 5 1.1 Introduction... 5 1.2 Intended Use... 5 1.3 Safety Notices... 5 1.3.1 Manufacturer... 5 1.4 Packaging, Transport, Storage... 6 1.5 Disposal and Recycling... 6 1.6 Connecting the Video Goggle to the Video Eye Analyser System... 6 1.7 Symbols... 6 1.8 Repairs... 7 1.9 Service... 7 1.9.1 Service address... 7

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Using the VG40 Video Goggle... 9 2.1 How the Video Goggle functions... 9 2.2 Putting the Video Goggle On... 10 2.3 Adjusting the Video Goggle... 10 2.3.1 Horizontal Eye Position (Symbol H)... 11 2.3.2 Vertical Eye Position (Symbol V)... 11 2.3.3 Focus (Symbol F)... 11 2.4 Video Goggle with Visor Open... 11 2.5 Video Goggle with Visor Closed... 12 2.6 Cleaning and disinfection... 13 2.6.1 Cleaning the Goggle and the Infrared Mirrors... 13 2.6.2 Disinfecting the Face Cushion... 13 2.7 Replacing the Face Cushion... 13 2.8 Replacing the Head Band... 13

3

Troubleshooting... 15

4

Technical Data... 17 4.1 4.2 4.3 4.4 4.5 4.6 4.7 4.8

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Definition of types... 17 Mechanical Construction... 17 Patient Interface... 17 Measurement Resolution... 17 Video Camera... 17 Power Supply... 18 Laser/LED... 18 Equipment Label... 18

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Table of Contents VG40 Video Goggle • User Manual

4.9 Environmental Conditions... 19 4.10 Standards... 19

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1

General Notes and Connecting the Device

1.1

Introduction Before using the device, please take a few moments to read this User Manual, paying particular attention to the safety notices.

1.2

Intended Use The video goggle is designed to monitor the eye movements. Two infrared cameras record video images of a single eye (monocular recording) or of both eyes (binocular recording). For further evaluation, the video signals are transmitted to a computer system which analyses the eye movements.

1.3

Safety Notices The safety notices are designed for the safety of not only the patient and user, but also for the safety of the device. For greater visibility, the safety notices are framed and accompanied by the word Warning! or Caution! Warning · Denotes a possible danger that could result in injury to the user or patient. Caution · Denotes the possibility of damage to the device or of a faulty measurement resulting from improper use. 1.3.1

Manufacturer

GN Otometrics A/S 9 Hoerskaetten, DK-2630 Taastrup, Denmark T: +45 45 75 55 55, F: +45 45 75 55 59 www.otometrics.com

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General Notes and Connecting the Device

1.4

Packaging, Transport, Storage The video goggle is securely packaged in a box with inserts to protect the unit during transport. Save the packing material for storage and transport of the Goggle. In most cases, the product will be delivered to you by one of our sales staff. Otherwise it will be shipped by post or through a forwarding agent. Note · Upon receipt, please check the package for visible external damage. If you find any, please notify the shipper immediately! If you intend to store or temporarily store the unit on your premises, please ensure that it is stored in a dry room and is not subjected to temperatures outside the range -10°C - 45°C (15°F - 120°F).

1.5

Disposal and Recycling The Video Goggle Type 1047 may be disposed of as normal electronic waste according to local regulations.

1.6

Connecting the Video Goggle to the Video Eye Analyser System The VG40 Video Goggle is designed to be connected to a video eye analyser system. Please see the video eye analyser system User Manual for your system for connection instructions.

1.7

Symbols This symbol indicates that the VG40 Video Goggle complies with Type BF of EN 60601-1.

The VG40 device is CE-marked according to the Medical Devices Directive 93 / 42 / EEC. xxxx

The instrument is marked with this symbol to indicate that it is electronic equipment covered by the Directive 2002/96/EC on waste electrical and electronic equipment (WEEE).

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General Notes and Connecting the Device

This symbol indicates that the user should refer to the associated warnings in this manual. This symbol indicates that the VG40 Video Goggle meets standards of insulation equivalent to Class II in accordance with EN60601-1. This symbol indicates that the VG40 Video Goggle is suited for direct current only.

1.8

Repairs Only authorised, qualified staff may make repairs to the device. This excludes replacement of the face cushion or headband.

1.9

Service Even the best electronic device can fail. Our service departments are there to provide you with speedy assistance in such an eventuality. 1.9.1

Service address

If there is a defect, please consult our service departments directly at our branch offices or at our main office at the address and numbers listed below: GN Otometrics A/S 9 Hoerskaetten, DK-2630 Taastrup, Denmark T: +45 45 75 55 55, F: +45 45 75 55 59 www.otometrics.com

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General Notes and Connecting the Device

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2

Using the VG40 Video Goggle

2.1

How the Video Goggle functions The video goggle contains two infrared cameras. These are located to the left and right, above each eye. Two infrared LEDs below the eyes, one on each side, and 6 LEDs above the eyes ensure proper lighting of each eye. See the positions below.

The infrared light makes video recording possible in complete darkness, even when the visor of the video goggle is closed. Through a process of deflection by the infrared mirror, the video cameras record the eyes and transmit the video images to the video analyser system for further processing.

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Using the VG40 Video Goggle

2.2

Putting the Video Goggle On Hold the goggle in one hand, taking the head band at the back in your other hand. Now take care to place the goggle on the patient's nose in such a way that he/she is able to breathe easily through the nose. Only then should you pull the head band around the back of the patient's head. Warning · Risk of injury! The infrared mirror may be damaged if the video goggle is dropped. If the mirror in the goggle is cracked or broken, do not use the goggle. Please contact our service department.

2.3

Adjusting the Video Goggle Once the video goggle has been placed comfortably on the patient's face, take a look at the video image of the right or left eye before beginning the test. In general, the following applies: if the whole eye is visible on the video analyser monitor, no adjustment will be necessary. If the pupil is too far off-centre, the video analyser may not be able to make a reliable and stable detection of the pupil location. In that case, make a horizontal or vertical adjustment to move the pupil more towards the centre of the video image (see the following section).

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Using the VG40 Video Goggle

2.3.1

Horizontal Eye Position (Symbol H)

Turning knob H on the right side of the goggle (where the right eye is located) allows you to move the video cameras horizontally and thus centre the video image of both eyes.

Focus Horizontal

Vertical

2.3.2

Vertical Eye Position (Symbol V)

The vertical position of the video cameras is adjusted by turning knob V under the left eye. 2.3.3

Focus (Symbol F)

The Focus knob F on the upper left side of the goggle (above the left eye) allows you to adjust the focus of the video image. The adjustment affects the left and right camera and thus the video image of the left and right eye simultaneously.

2.4

Video Goggle with Visor Open For vestibular tests in which the patient needs to see clearly, as in calibration and optokinetic testing, simply lift the visor until it snaps in lock at fully open position.

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Using the VG40 Video Goggle

2.5

Video Goggle with Visor Closed For all vestibular tests in which the patient has to be prevented from fixing his/her gaze, the visor must remain closed.

Caution · Prevent gaze fixation! To prevent the patient from fixing his/her gaze, it is essential to make sure that the visor is closed completely.

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Using the VG40 Video Goggle

2.6

Cleaning and disinfection Caution · Avoid damage to the video cameras! Jolting or dropping the goggle can damage the sensitive optics of the camera. 2.6.1

Cleaning the Goggle and the Infrared Mirrors

To clean the body of the goggle, use a slightly dampened cloth and conventional household plastic cleaner. The infrared mirrors may be cleaned with conventional eyeglass cleaner only. Should the goggle fog up, use a demisting solution, which can be obtained from your GN Otometrics dealer (see also 3 Troubleshooting X 15). Note · The black IR-filters covering the central infrared LEDs and the side infrared LEDs must not be moistened. Use only a dry cloth to clean the IR-filters. 2.6.2

Disinfecting the Face Cushion

Use alcohol pads (saturated with 70 % isopropyl alcohol, for example) to clean and disinfect the mask, particularly the face cushion.

2.7

Replacing the Face Cushion If the face cushion should need replacing after long use, you can order replacements at one of our branch offices. To remove the pad, simply nudge it inwards (away from the casing) with your thumb. After you have done this at several points, you can simply lift out the padding. When inserting the new cushion, make sure that the inner and outer seams of the pad fit completely into the grooves on the outside and inside of the casing.

2.8

Replacing the Head Band The head band has a Velcro closure. Open this to pull the band out of the eyelets on top of the goggle and at the earpieces. Reverse the process to insert the new head band.

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Using the VG40 Video Goggle

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Troubleshooting Problem: Possible cause: Solution:

Problem:

No video signal on the video monitor

• Missing or unreliable cable connection between video analyser and goggle. Check the cable connections. Power connection can be checked by turning on the fixation LED and looking into the goggle from the outside. A faint green glow should appear from the small holes right below the round black windows. Video image on monitor hazy, dark or noisy

Possible cause: Solution:

• Cameras may be out of focus. Adjust the focus with the focus adjustment knob until the image is sharp. Ensure that the headstrap is neither too tight nor too loose, since this could result in the correct focus position being outside the adjustment range.

Possible cause:

• The infrared mirrors of the video goggle are steamed up because the patient has perspired under the mask. Clean the infrared mirrors with an eyeglass cleaner, spray them with a demisting spray and then wipe dry in a circular motion with a soft cloth.

Solution:

Caution · Avoid damage to the mirror and mirror mount! Take great care not to apply excessive force when cleaning the mirror. This may result in damage to the mirror coating or to the mirror mounts. Possible cause Solution:

• One or more of the infrared LEDs are blocked, reducing the illumination of the eye. Clean the surface of the central and side LEDs. If the problem persists, the LEDs may be defective. Contact your local GN Otometrics dealer for service. Caution · Do not moisten the IR-filters! Use a dry cloth only.

Problem: Possible cause Solution:

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The video image is clear and crisp, but the video analyser cannot reliably detect the position of the pupil

• The eye position is too far outside the optimal area. Adjust the eye position by turning the knobs on the outside of the goggle.

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Troubleshooting

Possible cause Solution:

16

• If there is mascara on the eyelashes, the video analyser position markers can get "stuck" on the eyelashes. Remove the eye makeup. If possible, patients should be asked to come without makeup on.

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Technical Data

4.1

Definition of types VG40 corresponds to GN Otometrics A/S Type 1047.

4.2

4.3

4.4

4.5

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Mechanical Construction Weight:

320 g

Size (h x w x d):

12 x 18 x 12 cm

Patient Interface Distance pupil to pupil:

60 ± 8 mm

Distance eye to forehead:

22 ± 3 mm

Nose width:

30 ± 10 mm

Horizontal range of viewing angle (visor open):

± 55°

Vertical range of viewing angle (visor open):

± 30°

Measurement Resolution Horizontal measurement resolution:

0.4°

Vertical measurement resolution:

0.4°

Video Camera Number of cameras:

2

Outgoing signal:

Monochrome NTSC

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Technical Data

4.6

4.7

Operation mode:

Frame synchronised

Image sensor size:

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

Horizontal resolution:

320 pixels

Vertical resolution:

240 pixels

Frame rate:

60 Hz

Power Supply Supply voltage:

12 V DC ± 10 %, in accordance with EN 60601-1

Power consumption:

2.5 W ± 10 %

Laser/LED Laser/LED product:

CLASS 1 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.

4.8

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Equipment Label

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Technical Data

4.9

4.10

Environmental Conditions Operation ambient temperature:

+10 to + 40 °C, 30 - 105 °F

Storage ambient temperature:

-10 to + 45 °C, 15 - 120 °F

Transport ambient temperature:

-10 to + 45 °C, 15 - 120 °F

Relative ambient humidity:

30 to 75 %

Safety:

EN 60601-1, Class II, Type BF, IPX0

Electromagnetic compatibility:

EN 60601-1-2

Systems:

EN 60601-1-1

Standards

Notes on EMC (Electromagnetic Compatibility) • The VG40 Video Goggle 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 the User Manual of the Video Analyser and in this document should be followed closely. • Portable and mobile high-frequency communication devices, such as mobile phones, may interfere with the functioning of the video goggle.

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Technical Data

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

The video goggle 1047, VG40 is intended for use in the electromagnetic environment specified below. The customer or the user of the video goggle 1047, VG40 should assure that it is used in such an environment. Emissions test

Compliance

RF emissions CISPR 11

Group 1

RF emissions CISPR 11

Class B

Harmonic emissions IEC 61000-3-2

Class A

Voltage fluctuations/flicker emissions IEC 61000-3-3

Complies

Electromagnetic environment-guidance

The VG40 video goggle 1047 uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment. The VG40 video goggle 1047 is suitable for use in all environments, including domestic environments and those directly connected to public lowvoltage power supply networks that supplies buildings used for domestic purposes

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

The video goggle 1047, VG40 is intended for use in the electromagnetic environment specified below. The customer or user of the video goggle 1047, VG40 should assure that it is used in such an environment. Immunity test

IEC 60601 test level

Compliance level

Electromagnetic environment guidance

Electrostatic discharge (ESD)

+/- 6 kV contact

+/- 6 kV contact

IEC 61000-4-2

+/- 8 kV air

+/- 8 kV air

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

Electrical fast transient/burst

+/- 2 kV for power supply lines

+/- 2 kV for power supply lines

IEC 61000-4-4

+/- 1 kV for input/output lines

+/- 1 kV for input/output lines

Surge

+/- 1 kV differential mode

+/- 1 kV differential mode

+/- 2 kV common mode

+/- 2 kV common mode

IEC 61000-4-5

20

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.

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