TytoCare TytoHome Otoscope User manual

Document Number 760-00048 A04
Tyto Otoscope
TytoHomeTM
For Ears Exam
User Guide
Version 3.0

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Tyto Otoscope User Guide
Contents
1. General Safety Messages/Product Overview............................................................................................................3
1.1. General Safety Messages.....................................................................................................................................3
1.2. Product Overview ................................................................................................................................................3
2. Before the Exam........................................................................................................................................................3
2.1. Cleaning Instructions ...........................................................................................................................................3
2.2. Connect Otoscope Tip and Disposable Speculum ...............................................................................................4
3. Exam Menu ...............................................................................................................................................................4
4. Performing the Exam ................................................................................................................................................4
4.1. Select Which Ear to Exam....................................................................................................................................4
4.2. Video Tutorial and Animation .............................................................................................................................5
4.3. Preparing the Patient Before the Exam...............................................................................................................5
4.4. Before You Start: How to Conduct the Exam ......................................................................................................5
4.5. Guidelines for Recording .....................................................................................................................................6
4.6. Start Recording....................................................................................................................................................6
4.7. Stop Recording ....................................................................................................................................................7
4.8. After Recording the First Ear… ............................................................................................................................7
4.9. Review the Ears Screen.......................................................................................................................................8
4.10. Finishing the Ear Exam.......................................................................................................................................8
Important
This User Guide is subject to periodic review, update and revision.
The user of this product has sole responsibility for any malfunction that results from improper use,
faulty maintenance, improper repair, unauthorized service, damage, or alteration by anyone other than
Tyto Care Ltd. (TytoCare).
The safety, reliability, and performance of this device can only be assured under the following
conditions:
•The device has been used for its indicated use and according to the operating instructions in this
User Guide.
•All fittings, extensions, readjustments, changes, or repairs have been carried out by a TytoCare
authorized representative.
Tyto support may be contacted at +1-866-971-TYTO, [email protected]
PLEASE REVIEW THE GENERAL OPERATION USER GUIDE BEFORE READING THIS USER GUIDE
Distributed by:
TytoCare Inc.
106 W. 32nd street
New York, NY, 10001, USA
Tel: + 1 (866)-971-TYTO (8986)

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Tyto Otoscope User Guide
1.
General Safety Messages/Product Overview
1.1.
General Safety Messages
Warnings: A warning indicates precautions to avoid the possibility of personal injury or death.
Cautions: Acaution indicates a condition that may lead to damage to equipment, or a lower quality
of treatment.
Notes: Anote 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.
1.2.
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:
•By an adult at home, to perform an examination on themselves or others, with the results
submitted for subsequent review by a clinician
•By an adult at home, to initiate a live virtual visit with a clinician and enable examination during the
video conference
•By a clinician/healthcare professional from a remote location, via live video conference
•By a clinician/healthcare professional, with the patient physically present in the clinic.
2.
Before the Exam
2.1.
Cleaning Instructions
Clean the device before use. The cleaning should be done using 70% isopropyl alcohol wipes or
cloth/swabs (e.g. q-tips) dipped in 70% alcohol. Clean the outer surface by swabbing or wiping the
surface with the alcohol wipes. Use the q-tip swab, dipped in 70% alcohol, on narrow and less accessible
surfaces, such as the otoscope lens, located at the front of the otoscope.
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.

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Tyto Otoscope User Guide
2.2.
Connect Otoscope Tip and Disposable Speculum
Before you start using the device, it is important to connect the otoscope tip correctly. Connect the
otoscope to the Tyto device using the blue dot guiding marks:
Tyto Device
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.
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
otoscope and update the clinician if you’re using it during an online visit.
3.
Exam 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, select EARS from the examination selection screen, as shown below:
4.
Performing the Exam
4.1.
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. 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.
Select Right or Left ear
In this example, we press RIGHT EAR.
Note: Make sure the Otoscope tip is connected.
If it is not connected, a message will display:

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Tyto Otoscope User Guide
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.
4.2.
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 pressing the question mark symbol on top of
the TytoCare 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, press Start.
Device screen showing the Start button. Press Start when you are ready to begin the ear exam (see
below, Section 4.4. Before You Start: How to Conduct the Exam).
4.3.
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.
4.4.
Before You Start: How to Conduct the Exam
Before starting the exam, please take few moments to review the basic steps of 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 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 otoscope.
3. Example of an eardrum
Warning: Stop once you get a
view of the eardrum. Do not
push the otoscope any
further! 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.

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Tyto Otoscope User Guide
4.5.
Guidelines for Recording
The video must be recorded continuously, from before the otoscope enters the ear canal, until after it is
withdrawn. DO NOT start or stop the exam when the otoscope tip is inside the ear.
Observe the video carefully. Aim the 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.
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 otoscope tip out of the ear canal. Clean the lens
(located at the front of the ostoscope) carefully using alcohol wipes, until the image is clear again.
DO NOT insert the 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 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 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
press the App “ACTIVATE VIDEO” button to resume the Otoscope video playback.
If video is not displayed, either in the App or on the device, remove the otoscope from the ear.
If you do not succeed in reaching the eardrum, it may help to rotate the otoscope tip, to achieve a
better viewing angle of the eardrum.
Please note that the otoscope tip may become warm after long period of continous 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 otoscope tip
out, stop the recording, and wait a few minutes for the tip to cool down.
4.6.
Start Recording
Once you’re ready to begin the ear exam, press Start on the device. The device will immediately begin
recording video for the ear exam. Then, position the otoscope as shown in Section 4.4. Before You
Start: How to Conduct the Exam above.
Press Start on the Device to begin recording video for the Ear exam.
4.6.1.
Changing the illumination strength of the otoscope
The 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.
Warning: DO NOT let the tip of the otoscope get too close to the eardrum. It must NOT touch the
eardrum.

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Tyto Otoscope User Guide
4.7.
Stop Recording
Press Stop on the device after the tip is completely removed from the ear canal, and the desired video
of the eardrum has been captured. The Device will display a confirmation message.
Press STOP to stop recording Confirmation the video was recorded
4.8.
After Recording the First Ear…
After you record the first ear, you have several choices:
•Review the recording, and delete it if desired through the Tyto App
•Take another recording of the same ear using the Repeat button on the device
•Take a recording of the other ear using the Next Ear button on the device
•View the Ears screen and end the exam by pressing the Back arrow on the device
4.8.1.
Review or Delete the Recording
From the App, you can view or delete the recording.
4.8.2.
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.
4.8.3.
Exam the Other Ear
From the Device, you can examine the other ear.
Note: It is recommended to always record exams for both ears.
Note: After 45 seconds the video recording stops automatically, to prevent unduly long video
recording and subsequent over heating of the otoscope. If this happens, pull the otoscope tip out
of the ear canal, and retake the exam. It is suggested to wait a minute between ear exams.
Press Play on the App to view the recording
Press Delete on the App to delete the recording
Press Repeat (here in picture Add) on the Device to
record an additional video of the same ear.
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.

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Tyto Otoscope User Guide
4.9.
Review the Ears Screen
From the Device screen, press the back arrow to see the Ears screen:
You now have two options:
Press on the Right or Left Ear icons to record or re-record an exam
Press the back arrow to return to the Exam Selection screen.
4.10.
Finishing the Ear Exam
When you have completed the necessary video recordings, press Done on the device. This will stop
the video recording and exit the Ears exam.
When you press DONE, if you have not recorded videos for both ears, a warning screen appears.
The device will indicate with a blue 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, press
the Trash Can icon to delete the selected video.
Please refer to the General Operation User Guide, beginning in Section 7.7.2 Recorded Exams,for further
instructions.
Press Exit to end the exam anyway.
Press the button on the right to record a video for the ear that was not recorded.
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 blue background under LEFT EAR indicates
that no recording was made for that ear.
Press Right Ear (in this example) on the Device to
record the next ear.