TytoCare TytoPro User manual

Document Number 760-00047 Rev. 04
Tyto Stethoscope
TytoProTM
For Heart, Lungs and Heart Rate Exams
User Guide
Version 3.0

Page 2
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
2.2. User Role: Performing Guided and Unguided Exams......................................................................................4
3. Exam Menu..................................................................................................................................................................4
4. Guided Exams ..............................................................................................................................................................6
4.1. Heart Exam and Lungs Exam ...........................................................................................................................6
4.2. Using the Tyto Stethoscope for Heart and Lungs............................................................................................6
4.3. Move on to the Next Examination Point.........................................................................................................7
4.4. Redoing an Examination Point ........................................................................................................................8
4.5. Heart Rate Exam..............................................................................................................................................8
4.6. Completing the Exam ......................................................................................................................................8
4.7. Completing the Visit ........................................................................................................................................8
5. Unguided Exams ..........................................................................................................................................................9
5.1. Connecting headphones to the device............................................................................................................9
5.2. Lungs exam......................................................................................................................................................9
5.3. Heart Exam ................................................................................................................................................... 11
5.4. Heart Rate exam........................................................................................................................................... 12
5.5. General Audio exam..................................................................................................................................... 12
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)

Page 3
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 medical professional in another location.
The stethoscope device connects to your Apple (iOS) devices to facilitate the process of communicating data
and video with the clinician. Computer software manages the process on the clinician’s end.
This Tyto Stethoscope is designed for use either in a home environment or at a clinic. It can be used in a
number of scenarios and on any person:
•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.
•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;
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.

Page 4
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: As 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.
2.2.
User Role: Performing Guided and Unguided Exams
Two methods can be used for examinations conducted with the TytoProTM system.
Guided exams are intended for use by any person who is not a healthcare professional, or a healthcare
professional who is not qualified to perform auscultation and/or a physical exam, and who requires a more
detailed, step-by-step approach to the exam. Guided exams lead the user through the process of performing
and viewing exams. See Section 4. GUIDED EXAMS for more information.
Unguided exams are intended for healthcare professionals, who have medical knowledge, and are proficient
in heart and lungs auscultation. Unguided exams provide a streamlined approach allowing more flexible
recording and faster operation, with minimal instructions for use. See Section 5. Unguided Exams for more
information.
The type of user role, guided or unguided, is defined by the System Administrator when your user was
created.
Contact the System Administrator of your TytoCare system to determine whether your user is defined as
Guided or Unguided, or in case you wish to change your user role.
3.
Exam Menu
Note: Refer to the TytoProTM 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:

Page 5
Tyto Stethoscope User Guide
Tyto Device
App
The Stethoscope tip is used to perform the following four 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
•The General Audio Exam enables general body auscultation, such as bowel sounds, carotid blood flow etc.
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:

Page 6
Tyto Stethoscope User Guide
«GUIDED Exams»
4.
GUIDED 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 in positioning the stethoscope
correctly on the correct points:
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.
Tyto Device
Tyto App
When the stethoscope is positioned on the desired point, press START on the device to begin the recording.
4.2.
Using the Tyto Stethoscope for Heart and Lungs
When using and 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: In order to achieve a high quality and clear recording of the lungs sound, 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.

Page 7
Tyto Stethoscope User Guide
«GUIDED Exams»
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]

Page 8
Tyto Stethoscope User Guide
«GUIDED Exams»
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 identified the recording was in a 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 exam 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, refer to Section 8.8 Completing the Exam, and Section 8.9. Sending the Store-and-
Forward Data to the Clinician,in the Tyto Device User Guide.

Page 9
Tyto Stethoscope User Guide
«UNGUIDED Exams»
5.
Unguided Exams
5.1.
Connecting headphones to the device
To listen to the auscultation sounds directly, connect headphones to the Tyto device audio jack, which is
located at the bottom of the device, usually covered by a rubber band, as shown in the images below. Prior to
entering the exam (heart, heart rate or lungs) a notification will be shown until the headphones are connected.
Once connected, the exam will continue.
Please make sure you insert the headphones into the correct socket, as the charger socket is located next to
the headphones jack.
Please note that you can also insert the headphones into the audio jack, located on the stethoscope tip itself.
Connect headphones to the
Tyto device
Headphones connected
5.2.
Lungs exam
Press on Lungs to begin the examination.
The device will immediately begin to record lungs auscultations. The red blinking dot, located at the upper-
right corner of the device, as well as in the App, indicates that sound recording is activated.
Device
App
Note: The headphones must meet the following specifications:
•Impedance minimum: 16 ohm, typical 32 ohm
•Frequency response: minimum 20 –10,000Hz
•Plug jack: 3.5mm stereo

Page 10
Tyto Stethoscope User Guide
«UNGUIDED Exams»
5.2.1.
Lung Lobes Tagging
To indicate where on the chest or back you are placing
the stethoscope (which lung lobe you are currently
listening to), press on the appropriate tag (LUL, RUL,
etc.) to indicate the area of auscultation. This tagging is
essential to allow the diagnosing physician, who will
listen to the recorded sound remotely, to know which
lobe he is listening to at a given moment. Every time
you move the stethoscope to a different area, make sure you accompany this action by pressing the relevant
lobe in the device.
This tagging information will be displayed to the clinician when he listens to the recorded exam.
Note that the selected lobe, the area being recorded, will be marked in blue. A green tag indicates an area that
has already been examined at least once. Press on SWITCH SIDE to toggle between back and front.
Note: In order to achieve a high quality and clear recording of the lungs sound, please make sure the
patient breathes deeply and slowly, using his mouth, and sits in an upright position. In addition, please
minimize noise during the exam, to prevent ambient sounds from affecting the recording.
Note: Please make sure the surface of the stethoscope is parallel to the patient's skin, and that the
entire membrane touches the patient's skin. This is necessary to achieve strong signal strength.
5.2.2.
Volume and Sound Filters
To access the Advanced Clinician options of the device Settings menu, swipe down on the device. These
settings can be used to change the default audio filters. The default audio filter for heart / heart rate exam is
Bell and for lungs exam is Diaphragm.
Other optional filters for lungs sounds are Wide for amplification of a wider range of frequencies, or Enhanced
Diaphragm, which amplifies the lungs sound frequencies and lowers other frequencies, such as the heart
sounds.
In addition, you have a Boost option, which amplifies the sound acquisition. The Boost is helpful in cases of
shallow breathing or low breathing sounds. The Boost option is enabled by default for the Lungs exam. If you
wish to reduce the sound amplification, turn off the Boost option.
Additionally, the volume of sound heard via the headphones can also be controlled by swiping down the device
screen anytime during the recording, and moving the volume slider at the bottom to the right or left
5.2.3.
Completing the Lungs Exam
When you have performed the necessary auscultations, and have recorded all necessary locations on
back and front, press Done on the device. This will stop the sound recording and exit the Lungs exam.
The device will indicate with a blue check mark that the lungs exam was recorded.
The App displays the recorded lungs exam, and enables listening to the exam. Please note that the back and
front sides will be displayed as separate recordings/lines.
Select ‘Advanced Clinician’
Select Audio Filter and Adjust Volume
Example of an exam
where LUL was
examined at least once,
and LLL is being
examined now

Page 11
Tyto Stethoscope User Guide
«UNGUIDED Exams»
Device
App
Please refer to Section 8.6 After the Exam in the Tyto Device General Operation User Guide for further
instructions.
5.3.
Heart Exam
Press on Heart to begin the examination:
The device will immediately begin to record heart auscultations. The red blinking dot, located at the upper-
right corner of the device, as well as in the App, indicates that sound recording is activated:
5.3.1.
Heart Auscultation Areas Tagging
To indicate on which heart auscultation area (heart valve) you place the stethoscope, press on the appropriate
tag (Aortic, Pulmonary, Tricuspid or Mitral). This tagging is essential to allow the diagnosing physician, who
will listen to the recorded sound remotely, to know which auscultation area he is listening to at a given
moment. When you move the stethoscope to a different area, make sure you press the relevant valve area in
the device. This tagging information will be displayed to the clinician when he listens to the recorded exam.
The area being recorded is marked blue. A green tag indicates an area that has been examined at least once.
LEOPOLD GORANNASKY
Tyto Device
Tyto App

Page 12
Tyto Stethoscope User Guide
«UNGUIDED Exams»
5.3.2.
Volume and Sound Filters
Swipe down on the device to access the Advanced Clinician options, to change the default audio filters. The
volume can also be controlled by moving the bottom slider to the left or right. This screen displays if you swipe
down the device screen during recording.
5.3.3.
Finishing the Heart Exam
When you have completed the necessary heart auscultations, and have recorded all necessary locations,
press Done on the device. This will stop the recording and exit the Heart exam.
Tyto Device
Tyto App
5.4.
Heart Rate exam
Please refer to Section 4.5. Heart Rate Exam for instructions on performing this examination.
5.5.
General Audio exam
The general Audio exam enables general body auscultation, such as for bowel sounds, carotid blood flow
(bruit) sounds, etc. The Audio exam is accessed using the second screen of the exam selection in the device
(next to the Skin exam). Swipe right to navigate to the second screen, and then press the Audio icon.
Please insert the stethoscope before starting the exam, as in heart and lungs exams. Then, place the
stethoscope on the required position, depending on the clinical need. Press Start to begin audio recording, and
Done when finished.
LEOPOLD GORANNASKY
Example of an exam where Aortic area was examined at
least once, and Pulmonary area is being examined now
The device indicates with a blue check
mark that the heart and lungs exams
were recorded.
The App displays the recorded heart
exam, and enables listening to the
exam, if necessary, or deleting it if the
recording was not as desired.
Select ‘Advanced Clinician’
Select Audio Filter and Adjust Volume