TytoCare TytoHome Tyto Otoscope User manual

TytoHome
Tyto Otoscope
User Guide
August 2019
Document Number: 760-00048 C01

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TytoHome Tyto Otoscope User Guide
Important Notice
All information included in this document, such as text, graphics, photos, logos and images, is the
exclusive property of TytoCare Ltd. and protected by United States and international copyright
laws. Permission is granted to view and photocopy (or print) materials from this document for
personal, non-commercial use only. Any other copying, distribution, retransmission or modification
of the information in this document, whether in electronic or hard copy form, without the express
prior written permission of TytoCare Ltd., is strictly prohibited. In the event of any permitted
copying, redistribution or publication of copyrighted material, no changes in, or deletion of, author
attribution, trademark legend or copyright notice shall be made.
© 2019 TytoCare Ltd. All rights reserved.
Manufacturer Information
TytoCare Ltd.
14 Beni Gaon Street,
Netanya, Israel 4250803
Tel: [phone]
Fax: [phone]
Email: [e-mail]
Website: www.tytocare.com

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TytoHome Tyto Otoscope User Guide
Table of Contents
General Safety Messages/Product Overview 4
General Safety Messages 4
Product Overview 4
Before the Exam 6
Cleaning and Disinfection instructions 6
Before taking a measurement 6
Connect Otoscope Tip and Disposable Speculum 6
Exams Menu 9
Performing the Exam 10
Select Which Ear to Exam 10
Video Tutorial and Animation 11
Preparing the Patient Before the Exam 11
Before You Start: How to Conduct the Exam 11
Guidelines for Recording 13
Start Recording 14
Changing the Illumination Strength of the Otoscope 15
Stop Recording 15
After Recording the First Ear 16
Review or Delete the Recording 16
Take Another Recording of the Same Ear 16
Exam the Other Ear 17
Review the Ears Screen 17
Finishing the Ear Exam 18

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TytoHome Tyto Otoscope User Guide
General Safety Messages/Product Overview
General Safety Messages/Product Overview
General Safety Messages
Warning: A warning indicates precautions to avoid the possibility of personal injury or
death.
Caution: A caution indicates a condition that may lead to damage to equipment, or a lower
quality of treatment.
Note: A note provides other important information.
Disclaimer
Information provided by TytoCare is believed to be accurate and reliable. However, TytoCare
assumes no responsibility for the use of such information, nor for any infringements of patents or
other rights of third parties, that may result from its use.
Intended use
The Tyto Otoscope is an electronic otoscope that enables capturing andtransmission of video and
still images of the external ear canal and tympanic membrane, whereby a clinician at one location
on an IP network can view images and videos of a patient on site or at a different location on the
IP network with the signal carried on an IP connection between the two locations.
Product Overview
The Tyto Otoscope™ is a user-friendly, electronic otoscope that digitally records video imaging of
the ear canal and eardrum.
The otoscope tip connects to your Tyto Device to facilitate the process of communicating data and
video with other clinicians or healthcare professionals. Recorded data may be forwarded for
diagnosis by another clinician in a different location.
The Tyto Otoscope is designed for use in a clinical or home environment. It can be used in a
number of scenarios:
lBy an adult at home, to perform an examination on themselves or others, with the results sub-
mitted for subsequent review by a clinician.
lBy an adult at home, to initiate a live virtual visit with a clinician and enable examination during
the video conference.

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General Safety Messages/Product Overview
lBy a clinician/healthcare professional from a remote location, via live video conference.
lBy a clinician/healthcare professional, with the patient physically present in the clinic.

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TytoHome Tyto Otoscope User Guide
Before the Exam
Before the Exam
Cleaning and Disinfection instructions
The Tyto Device should be low level disinfected in between uses. Make sure that the Tyto Device is
turned off and thoroughly wipe the device’s exterior with 70% isopropyl Alcohol wipes or with pads
impregnated with 70% ethyl Alcohol. Allow the Tyto Device for air dry for at least two minutes.
Before taking a measurement
Use the Q-tip swab, dipped in 70% isopropyl/ethyl alcohol, on narrow and less accessible surfaces,
such as the otoscope lens. Make sure the lens, located at the front of the camera, is clean.
Note: Do not use any other cleaning materials or chemicals to use the otoscope.
Do not use a brush to clean the otoscope’s lens, as it might scratch it.
Connect Otoscope Tip and Disposable Speculum
Before you start using the device, it is important to connect the otoscope tip correctly. Connect the
otoscope tip to the Tyto Device using the blue dot guiding marks:
Tyto Device

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Before the Exam
Otoscope Tip
Otoscope Tip and Tyto Device connected
After connecting the otoscope tip, place a
disposable speculum on the tip and lock it
in place by rotating it:

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Before the Exam
Note: Choose the correct size of disposable specula: for adults use the shorter specula with
wider opening (4.0mm), which enables a wider Field of View; for small children use the longer
specula with the narrower opening (3.0mm).
Note: Do not use an otoscope disposable speculum that has cracks or contains sharp
objects.
Note: Discard the disposable speculum after use.
Note: In case you feel pain or discomfort during the ears exam, stop the exam, retract the
Tyto Otoscope and update the clinician if you’re using it during an online visit.

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Exams Menu
Exams Menu
Note: Refer to the TytoHomeTM General Operation User Guide for preliminary instructions
on logging in to the system and viewing the Exam menu.
To start an ear exam, tap EARS from the examination selection screen, as shown below:
Tyto Device

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Performing the Exam
Performing the Exam
Select Which Ear to Exam
The Ears selection screen allows you to select the ear you are about to exam, and shows which
ears have been examined. Initially, the display indicates that no recordings have been made.
Note: Make sure the Tyto Otoscope tip
is connected. If it is not connected, a
message will display:
When performing the exam, you can start
with either the right or left ear. It is highly
recommended to always examine both
ears, even if only one ear aches.
Tap Right or Left ear.
In the example below, we tap RIGHT EAR.
Warning: it is important to select the correct ear (left or right), and to correctly identify the
side that you are recording. Note that patient’s sides are mirrored. Mixing between sides
could mislead the diagnosing clinician.

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Performing the Exam
Video Tutorial and Animation
The first time you do the exam, a video tutorial will be displayed on the App, guiding you in
performing an ears examination. This tutorial is required when you do your first ear exam. It is
always available when performing later exams, and can be viewed by clicking the (question
mark) on top of the Tyto App screen.
Every time you perform an ear exam, a short animation displays, reminding you of the key
considerations that should be taken into account during the ear examination. As only the video
tutorial has the detailed instructions, it is recommended to always watch the tutorial before use.
Once you are ready to perform the ear exam and start video recording, tap Start.
Figure 1-1. Device screen showing the Start button. Tap Start when you are ready to begin
the ear exam (see below Section - Before You Start: How to Conduct the Exam).
Preparing the Patient Before the Exam
Before starting the exam, the patient should sit comfortably, and be encouraged to not move their
head during the exam.
For small children under the age of three, another adult can hold the child’s head to prevent
sudden movement during the exam. For babies, it’s advisable to lay the baby on its back and move
the head to one side, while the other adult holds the baby and prevents head movement.
Distracting the child’s attention during the exam, using a TV show or toy, can also be helpful.
Before You Start: How to Conduct the Exam
Before starting the exam, please take few moments to review the basic steps of the exam.

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Performing the Exam
1. Pull back gently on ear to straighten ear
canal. For small children, pulling the ear
back and down can be more effective.
2. Insert the Tyto Otoscope into the ear canal.
Warning: Be Careful NOT TO TOUCH EARDRUM. In case the canal is blocked or obstructed
by wax / cerumen, stop the examination and pull back the Tyto Otoscope.

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Performing the Exam
3. Example of an eardrum:
Warning: Stop once you get a view of the eardrum. Do not push the Tyto Otoscope any fur-
ther! You can use the yellow dotted circle as a guide to know when you are too close to the
eardrum. During an online visit, update the clinician when you see the eardrum.
Guidelines for Recording
The video must be recorded continuously, from before the Tyto Otoscope enters the ear canal,
until after it is withdrawn. DO NOT start or stop the exam when the Tyto Otoscope tip is inside the
ear.
Observe the video carefully. Aim the Tyto Otoscope tip towards the darker area, which indicates a
deeper part of the ear canal, and follow this direction until the eardrum becomes visible.
Inserting the otoscope tip deeper into the ear canal should be performed gently,slowly and
gradually.
Warning: DO NOT let the tip of the Tyto Otoscope get too close to the eardrum. It must NOT
touch the eardrum.
If the image is blurred, it’s probably because wax is attached to the camera lens (usually seen as a
yellow area on the camera). In that case, pull the Tyto Otoscope tip out of the ear canal. Clean the
lens (located at the front of the Tyto Otoscope) carefully using alcohol wipes, until the image is
clear again.
DO NOT insert the Tyto Otoscope tip further if the ear canal is blocked with wax, if you detect a
foreign body in the ear canal, the image is blurred, the patient feels pain or discomfort, the quality

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Performing the Exam
of the video in the App is low, or when you cannot identify the path in the ear canal towards the
eardrum. In the event of pain or discomfort, pull the Tyto Otoscope slowly backwards.
Warning: When performing an online exam while the clinician experiences poor network
conditions, the App might stop displaying the video. In case of self-examination it is important
to tap ACTIVATE VIDEO to resume the Otoscope video playback.
Note: If you wish to examine your own ears while the App does not show the Otoscope
video, please ask someone else to hold the Tyto Device and perform the exam, so he could see
the device’s screen, which is required to perform the ears exam successfully and safely.
If video is not displayed, either in the App or on the device, remove the Tyto Otoscope from the
ear.
If you do not succeed in reaching the eardrum, it may help to rotate the Tyto Otoscope tip, to
achieve a better viewing angle of the eardrum.
Please note that the Tyto Otoscope tip may become warm after long period of continuous
recording (above 30 seconds). In case the environment (ambient) temperature exceeds 95°F (35°C)
during operation, the otoscope may get heated even faster. If the patient feels discomfort in their
ear, pull the Tyto Otoscope tip out, stop the recording, and wait a few minutes for the tip to cool
down.
Start Recording
Once you’re ready to begin the ear exam, tap Start on the device. The device will immediately
begin recording video for the ear exam. Then, position the Tyto Otoscope as shown in Section -
Before You Start: How to Conduct the Examabove.
Tap Start on the Device to begin recording
video for the Ear exam.

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Performing the Exam
Changing the Illumination Strength of the Otoscope
The Tyto Otoscope tip includes built-in illumination. You can adjust the strength of the illumination
by swiping down on the device screen during the video recording, and then increasing or
decreasing the strength using the bottom slider. This illumination level will be kept for future ear
examinations.
Stop Recording
1. Tap Done on the device after the tip is com-
pletely removed from the ear canal, and
the desired video of the eardrum has been
captured.
2. The Device will display a confirmation mes-
sage.
Note: After 45 seconds the video recording stops automatically, to prevent unduly long
video recording and subsequent over heating of the Tyto Otoscope. If this happens, pull the oto-
scope tip out of the ear canal, and retake the exam. It is suggested to wait a minute between
ear exams.

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Performing the Exam
After Recording the First Ear
After you record the first ear, you have several choices:
lReview the recording, and delete it if desired through the Tyto App
lTake another recording of the same ear using the Repeat button on the device
lTake a recording of the other ear using the Next Ear button on the device
lView the Ears screen and end the exam by pressing the Back arrow on the device
Review or Delete the Recording
From the Tyto App, you can view or delete the recording:
lTap Play on the App to view the recording.
lTap (Delete) on the App to delete the recording.
Note: After the video is captured, it will be displayed in the App. Please review the video in
the App, and verify that the image is clear and sharp.
Take Another Recording of the Same Ear
From the Device, you can take another video of the same ear. You can have several videos of each
ear.
Tap Redot (in picture here Add) on the
Device to record an additional video.

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Performing the Exam
Exam the Other Ear
From the Tyto Device, you can examine the other ear.
Note: It is recommended to always record exams for both ears.
Tap Right Ear (in this example) on the
Device to record the next ear.
Review the Ears Screen
From the Device screen, tap the back arrow to see the Ears screen:
In this example, the green background and
check mark next to RIGHT EAR indicates
that at least one recording was made for
the right ear. The purple background under
LEFT EAR indicates that no recording was
made for that ear.
You now have two options:
lTap the Right or Left Ear icons to record or re-record an exam.
lTap the back arrow to return to the Exam Selection screen.

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Performing the Exam
Finishing the Ear Exam
When you have completed the necessary video recordings, tap (DONE) on the device. This will
stop the video recording and exit the Ears exam.
When you tap DONE, if you have not recorded videos for both ears, a warning screen appears.
lTap Exit to end the exam anyway.
OR
lTap the button on the right to record a video for the ear that was not recorded
The device will indicate with a green check mark that the ear exam was recorded:
If you review the recorded video in the app,
and decide that you do not want to share it
or keep it, tap the Trash Can icon to delete
the selected video.
Please refer to Section - After the Exam in
the General Operation User Guide for
further instructions.