DizzyDoctor DDS40401 Manuale utente

Getting Started Guide

Thank you for purchasing the Vertigo Recording Goggles for use with the DizzyDoctor

System. Please carefully read these instructions to ensure safe and proper operation.

Product Description

The DizzyDoctor system consists of the Vertigo Recording Goggles version 1.0 (VRG), the

DizzyDoctor iPhone app, and the DizzyDoctor website. It enables users to properly perform

and track eye movement recordings as they are experiencing episodes of disequilibrium

or vertigo when remote from their treating Health Care Practitioner. The username and

password protected eye-movement videos automatically upload to the DizzyDoctor website.

Videos may then be processed for a small fee*, so that the raw video eye movements as well

as the eye tracking data and head stability data are presentable to a healthcare practitioner

at the next user follow-up. All these data sets are available in the healthcare practitioner

website portal after the user securely logs in with their healthcare practitioner. The user may

also view their personal processed videos in their user portal for their own education. All the

information provided in the healthcare practitioner portal at www.DizzyDoctor.com website

is helpful to the user’s healthcare practitioner in helping create a more accurate differential

diagnosis regarding why the user is episodically dizzy or vertiginous.

*Please note each time you select PROCESS VIDEO it will cost you 1 credit. Credits may be purchased on

the DizzyDoctor App or at www.DizzyDoctor.com for approximately $19.99/credit

The DizzyDoctor system uses the following components:

1. A specially designed iPhone 5/5s/6/6s/6plus/7/7plus goggle recording set

named “Vertigo Recording Goggles” or VRG.

2. A magnetic box and a soft optics bag for storage of the Vertigo Recording

Goggles.

A user-supplied Apple iPhone 5/5s/6/6s/6plus/7/7plus operating with iOS 8.0 or

later. NOTE: the iPhone 5/5s/6/6s/6plus/7/7plus must be purchased separately.

4. The DizzyDoctor iOS app (available on the Apple App Store) that is used to

record, view, and upload encrypted video and gyroscopic head positional

data to the secure DizzyDoctor web server.

Our secure web server is enabled to review and process unlocked

videos recorded on the mobile application. Access the user portal at

www.dizzydoctor.com

NOTE: the DizzyDoctor web app is supported on the

following web browsers: Google Chrome, Internet Explorer 8, Firefox and Safari.

Package Contents

• DizzyDoctor Vertigo Recording

Goggle compatible with either iPhone

5/5s/6/6s/6plus/7/7plus. ( NOTE: The

User must purchase the proper Vertigo

Recording Goggle for their model iPhone)

• Soft storage optics bag

• Quick Start Guide

• Getting Started Guide

IOS Download Information

Download the DizzyDoctor mobile IOS application

from the Apple App Store. To nd, search for

“DizzyDoctor” under the search option in the App

Store. Follow the steps within the app to create

a user account or visit www.dizzydoctor.com

to create a user account. Contact DizzyDoctor

support on the website with any questions.

Indications For Use

The DizzyDoctor System is intended to provide information used to assist in the identication

of balance disorders such as benign paroxysmal positional vertigo (BPPV) and detect

nystagmus in positional maneuvers such as Dix-Hallpike and supine positional tests, by

recording, tracking, measuring, storing, and displaying vertical, horizontal, and torsional eye

movements. The DizzyDoctor System is intended for use by users during an episode of vertigo

remote from their treating healthcare practitioner’s clinic. However, it may also be used by the

healthcare practitioner in their clinic to evaluate the patient. This device does not provide any

medical diagnosis and is intended to be part of a larger balance assessment battery used by

the healthcare practitioner to help provide a more accurate diagnosis regarding their patient’s

vertiginous complaints.

Storage and Handling

Store the device in the provided soft container when not in use. Store at a temperature

between -20° and 45° C (-4° and 113°F) and humidity between 5% and 80%. Do not store in

damp area as this may cause damage to the device.

The full user manual is available online at

ww.dizzydoctor.com/user_manual.pdf .

Please be sure to read the full manual before use.

Accessories Required

Apple 5/5s/6/6s/6plus/7/or 7plus with iOS 8.0 or

later (Available for purchase from Apple Retailers).

For more info on purchasing an iPhone visit

www.Apple.com/buy/

Please note these are not supplied by

DizzyDoctor System

Full User Manual

Maintenance/Cleaning

The Vertigo Recording Goggles should be

cleaned with a standard home cleaning

solution and a clean cloth. Care should be

taken not to scratch the lens on the Vertigo

Recording Goggle.

Do not submerge in

water

. Cleaning the goggles ensures a clear

recording.

To clean use clean disinfectant wipes and

wipe around the interior pad. Then continue

to wipe the rest of the goggle set. Do not

wipe the lenses with the disinfectant wipe!

Only wipe the lenses with a clean microber

cloth.

Set Up Instructions

1. Clip your smartphone in the holder with the iPhone touch screen pointed away from the

holder and the camera on the iPhone placed directly over the clear magnication lens. Make

sure that it securely ts. Different holders are available for the iPhone 5/5s, iPhone 6/6s,

IPhone 6 plus, iPhone 7/7 plus.

Note: You must remove your personal iPhone holder/protector before you can place your

iPhone into the goggle holder.

2. Put the goggles over your head and make sure to adjust the head-strap so that they TIGHTLY

t on your face

3. Make sure the iPhone is securely clipped in and that the goggles are nice and snug so that

they will not move during testing.

4. Now remove the goggles and proceed to DizzyDoctor Mobile App Operating Instructions on

the next page.

DizzyDoctor Mobile App Operating Instructions

1. Log in or sign up. To sign up, follow the instructions to create a

username and password. Once you are signed up and logged in,

you are ready to record your eye movement videos.

2. Get a friend or family member to aid in your recordings to ensure

your safety if you experience vertigo while testing with the VRG.

3. VERY IMPORTANT: You must start the eye movement recording

by sitting on a table/bed with your feet and body positioned as

shown to the right. Your nose should be directly in front of you

and in a neutral position (i.e. not pitched up or down).

4. Press the green button on the top of the VRG to turn on the goggle

lighting. Then click on STEP BY STEP on the iPhone screen to

start the standard recording session.

5. Follow the set up instructions shown on the IPhone App to properly

perform the Dix-Hallpike and supine positional test.

6. Follow the on screen pictorial and verbal instructions

Step-By-Step

Starting Position: Step 1: Step 2: Step 3:

7. Once the recording is complete take the goggles off of your

head, and turn off the VRG light.

8. Review the videos from the recording session in the video

player area of the app. If the videos show your eye in the

center of the recording screen and they appear in focus then click the

process video button (this will cost you one credit). This process saves the

video on the www.DizzyDoctor.com website and provides the opportunity

to play the eye movement videos simultaneous with the eye tracking

Nystagmograms and head stability data.

Step4: Step 5: Step 6: Step 7:

ADVANCED TESTING ADVANCED TESTING ADVANCED TESTING

9. Go to your Health Care Practitioner and present your data

for review in the Healthcare practitioner portal area. You will

be asked to enter your secure log in and password on the

DizzyDoctor Website while in your physician’s oce

For more information, please visit www.DizzyDoctor.com

to access the complete instruction manual.

FAQ’s

For answers to Frequently Asked Questions and Troubleshooting

Tips visit www.dizzydoctor.com/FAQ.html

Contraindications

This device may only be used for the recording of eye movements in

the 4-7 pre-determined positions. Do not use for any other purpose

to avoid injury to the user or damage to the device.

General Safety Precautions

CAUTION: This device is not designed or intended to provide an

independent diagnosis of any vestibular disorder or any other

eye or ear ailments. This device should not be used as a basis for

starting or modifying treatment without independent conrmation by

medical examination from a healthcare practitioner. Do not attempt

self-diagnosis or self-treatment based on the recording results and

analysis. Self-diagnosis or self-treatment may lead to deterioration

of your health or death.

INTERPRETING LINE TRACINGS AND EYE MOVEMENTS IS DIFFICULT

AND SHOULD ONLY BE DONE BY A MEDICAL PROFESSIONAL. DO NOT

RELY ON YOUR OWN INTERPRETATIONS TO SELF DIAGNOSE!!

CAUTION: Proper care and handling is essential for satisfactory

performance for the DizzyDoctor device. Examine the device

thoroughly before and after use. If any damage or irregularities are

found, do not use the device.

Safety Precautions

• Do not use under the inuence of drugs or alcohol.

• Users should always consult their healthcare practitioner if

they notice changes in their health.

• Do not reuse the goggles without disinfecting it prior to use.

See Cleaning Instructions.

• Do not use the device with any objects plugged into the

iPhone’s ports (i.e. headphone jack, lightning connector, 30-

pin connector).

• Store out of reach of infants, small children, or anyone

incapable of using the device properly.

• Do not use the device anywhere that the usage of the iPhone

is not permitted.

• Do not use the device in conjunction with water, or in a wet

environment.

CAUTION:

Do not use if you are pregnant. Do not use if you have a

preexisting heart condition. Do not use if you have a serious neck/

spine or back condition or have had previous spine surgery.

WARNING: CHOKING HAZARD

– Small parts not for children under

3 years or any individuals who have a tendency to place inedible

objects in their mouths.

TYPE BF APPLIED PART

– The DizzyDoctor Vertigo Recording

Goggles is a type BF applied part.

RECYCLE RESPONSIBLY

– Do not throw in the wastebasket. Please

recycle your plastics and battery responsibly.

Warranty

DizzyDoctor provides a limited warranty

for the Vertigo Recording Goggle product.

Please visit www.dizzydoctor.com for a

full description of the warranty.

Information

If any injury or adverse event occurs call 911 right away or report it to a healthcare practitioner

immediately. For general or product related comments, questions, concerns or experiences, please

DizzyDoctor Systems LLC

7625 Mesa College Dr Suite 200

San Diego, CA 92111

support@dizzydoctor.com

1-619-578-2425

• DizzyDoctor is a registered trademark owned by Ian Purcell, MD, Ph.D. Other Parties’

trademarks or registered trademarks are the property of their respective owners and should

be treated as such. U.S. patent information is available via request.

#DDS40401

• iPhone 4 Vertigo Recording Goggles

Dimensions: Height: 4.54in., Width:

2.31in., Depth: 0.37in.

Weight: 4.8oz.

#DDS40501

• iPhone 5 Vertigo Recording Goggles

Dimensions: Height: 4.87in., Width:

2.31in., Depth: 0.30in

Weight: 3.95oz.

#DDS405S01

• iPhone 5s Vertigo Recording Goggles

Dimensions: Height: 4.87in., Width:

2.31in., Depth: 0.30in.

Weight: 3.95oz.

#DDS40601

• iPhone 6 Vertigo Recording Goggles

Dimensions: Height: 5.44in., Width:

2.64in., Depth: 0.27in

Weight: 4.55oz.

#DDS406P01

•

iPhone 6 Plus Vertigo Recording Goggles

Dimensions: Height: 6.22in., Width:

3.06in., Depth: 0.28in.

Weight: 6.07oz.

#DDS406S01

• iPhone 6s Vertigo Recording Goggles

Dimensions: Height: 5.44in., Width:

2.64in., Depth: 0.28in.

Weight: 5.04oz.

#DDS406SP01

•

iPhone 6s Plus Vertigo Recording Goggles

Dimensions: Height: 6.22in., Width:

3.06in., Depth: 0.28in.

Weight: 6.07oz.

#DDS40701

• iPhone 7 Vertigo Recording Goggles

Dimensions: Height: 5.44in., Width:

2.64in., Depth: 0.28in.

Weight: 4.87oz.

#DDS407P01

•

iPhone 7 Plus Vertigo Recording Goggles

Dimensions: Height: 6.23in., Width:

3.07in., Depth: 0.29in.

Weight: 6.63oz.

Technical Description DizzyDoctor Vertigo Recording Goggle model number:

Visit us online at: Website: www.dizzydoctor.com | Facebook: facebook.com/dizzydoctor

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