TytoCare TytoHome User manual

Document Number 760-00051 Rev. 04
Tyto Stethoscope
TytoHomeTM
For Heart, Lungs and Heart Rate Exams
User Guide
Version 3.0

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Tyto Stethoscope User Guide
Contents
1. General Safety Messages/Product Overview..............................................................................................................3
1.1. General Safety Messages.................................................................................................................................3
1.2. Product Overview............................................................................................................................................3
1.3. Intended use and indications for use ..............................................................................................................3
2. Before the exam ..........................................................................................................................................................4
2.1. Connect the Stethoscope tip...........................................................................................................................4
3. Exam Menu..................................................................................................................................................................4
4. Performing the Exams .................................................................................................................................................5
4.1. Heart Exam and Lungs Exam ...........................................................................................................................5
4.2. Using the Tyto Stethoscope for Heart and Lungs............................................................................................5
4.3. Move on to the Next Examination Point.........................................................................................................6
4.4. Redoing an Examination Point ........................................................................................................................7
4.5. Heart Rate Exam..............................................................................................................................................7
4.6. Completing the Exam ......................................................................................................................................7
4.7. Completing the Visit ........................................................................................................................................7
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 Stethoscope User Guide
1.
General Safety Messages/Product Overview
1.1.
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.
Note: The Tyto Stethoscope is a class II device intended for use under prescription.
1.2.
Product Overview
The Tyto Stethoscope™ is a user-friendly, electronic stethoscope that digitally records heart, lung and other
internal auscultation, and transmits this sound data to a healthcare professional in another location.
The stethoscope device connects to your mobile devices to facilitate the process of communicating data and
video with the clinician.
The Tyto Stethoscope 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.
Warning: Users must have a basic understanding of smartphone operation to ensure proper use of
the product.
Warning: Users must have sufficient vision and hearing to follow the prompts on the product to
ensure proper use.
1.3.
Intended use and indications for use
The Tyto Stethoscope is an electronic stethoscope that enables transmission of auscultation sound data,
whereby a clinician at one location on an IP network can listen to the auscultation sounds 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. The Tyto stethoscope is intended for use by professional users in a clinical
environment or in conjunction with patients or lay users in a non-clinical environment.
Rx Only
Caution: Federal law (USA) restricts this device to sale by or on the order of a licensed practitioner.

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Tyto Stethoscope User Guide
2.
Before the exam
2.1.
Connect the Stethoscope tip
Before you start an exam, connect the stethoscope tip to the Tyto device using the blue dot guiding marks:
Connecting the stethoscope tip to the Tyto Device
Note: Since the stethoscope is placed directly on the skin, please use alcohol wipes to disinfect the
membrane of the stethoscope (black surface touching the skin) before each use.
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 one of the stethoscope exams, please select the relevant exam from the exams selection screen in
the Tyto device, as shown below:
Tyto Device
The Stethoscope tip is used to perform the following three types of exams:
•The Lungs exam enables lungs auscultation, listening to both the front and the back of the body
•The Heart exam enables heart auscultation
•The Heart Rate exam measures heart rate
Note: Make sure the stethoscope tip is connected prior to starting the exam. If it’s not, you’ll see a
message asking you to connect it:

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Tyto Stethoscope User Guide
4.
Performing the Exams
4.1.
Heart Exam and Lungs Exam
To avoid confusion between left and right sides, in the Heart exam and the Lungs exam you will first be
asked to confirm which is the patient’s right arm. This will help you to position the stethoscope correctly.
Then click NEXT on the device. You will see a picture with the first measurement point highlighted on the
screens of both the Tyto device and the Tyto App (in this example, a lung exam).
Tyto Device
Tyto App
When the stethoscope is positioned on the desired point, as guided by the device and app, press START on
the device to begin the recording.
4.2.
Using the Tyto Stethoscope for Heart and Lungs
When placing the device on the body, please take special care to note the placement positioning —the
left or right side —as indicated by the software.
When performing a lung exam on another person, you first perform the exam on the front of the
patient’s body and only afterwards on the back, as guided by the software. During the lung exam, the
person being examined should breathe in and out deeply and slowly.
•Place the Tyto Stethoscope firmly on the patient’s body at the indicated position. Place the device
directly on the skin, if possible. Otherwise it may be used over thin clothing (e.g. a shirt).
•Place the device in full contact with the patient’s body or clothing. Hold the stethoscope steady
during recording, and don’t move the device until the countdown completes. Try to remain as quiet
as possible, eliminating external sounds.
Note: To achieve a high quality and clear recording of the lungs, please make sure the patient
breathes deeply and slowly, through the mouth, and sits in an upright position. In addition, please
make as little noise as possible during the exam, to prevent ambient noise from disturbing the lungs
sound recording.
Note: Please make sure that the surface of the stethoscope is parallel to the patient's skin, and the
entire membrane touches the patient's skin. This is necessary to achieve strong signal strength.

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Tyto Stethoscope User Guide
Note: The instructions written below, regarding correct placement location on the body and the
signal strength feedback, are also displayed on the Tyto app. Use the Tyto app when doing a self-
exam to assist you in doing the exam correctly.
4.2.1.
Signal Strength
As the Tyto Stethoscope counts down during the recording process, you’ll see a signal strength bar indicating
the recording signal strength. The bar is not related to, nor indicative of, the patient’s health.
None means that the stethoscope is not
receiving any signal (not on body, etc.).
Noisy means you are either moving the
stethoscope on the body, pressing too
strongly, or there are strong external
sounds interfering.
Low means that you are using the
stethoscope correctly, but for some reason
the signal received is not strong enough.
The system may prompt you to redo the
exam to capture better data.
Strong means that you should keep doing
what you are doing.
4.3.
Move on to the Next Examination Point
Once the countdown is over and the point recording is complete, Tyto device
labels the point with a green label, and the exam moves automatically to the
next measurement point in the sequence.
Continue until you complete all measurement points. There are four
measurement points for the heart exam, and eight for the lungs exam: four
on the front and four on the back.
Note: The small body icon, located at the bottom-left corner of the lungs exam,
is used to switch between back and front.
Heart Exam [4 points]
Front Body Lungs Exam [4 points]
Back Body Lungs Exam [4 points]

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Tyto Stethoscope User Guide
4.4.
Redoing an Examination Point
If you are not satisfied with a recording for a specific point, you can click on the points to zoom in, pick the
point to redo, and redo the recording by pressing START.
If Tyto Stethoscope determined that the recording was of low quality, the device
will instruct you to redo the recording. Press RETRY and redo the same point.
4.5.
Heart Rate Exam
In the Heart Rate exam, place the Tyto Stethoscope on the middle of the chest (on the sternum), as
indicated on the device and App. Press START on the device to begin the exam.
Please conduct the exam silently, as speaking or other external noise may
cause the measurement to fail.
During the 20-second exam, you will see an indication of the signal quality received by the system:
Poor signal quality
Good signal quality
4.6.
Completing the Exam
Once you have collected data from all measurement points, press DONE to complete the exam.
The Exams screen will show the completed exams in blue (Heart and Heart Rate exams in this example), to
indicate that data was collected. At this point, you can choose to collect data for additional exams.
4.7.
Completing the Visit
To complete the visit, please refer to the General Operation User Guide, beginning in Section 7.7.2 Recorded
Exams,for further instructions.