TytoCare TytoPro User manual

TytoPro
General Operation
User Guide
Software version 5.2
August 2021
Document Number: 760-00058 D03

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TytoPro General Operation 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.
© 2021 TytoCare Ltd. All rights reserved.
Manufacturer Information
TytoCare Ltd.
14 Beni Gaon Street,
Netanya, Israel 4250803
Tel: [phone]
Fax: [phone]
Email: [email protected]
Website: www.tytocare.com

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TytoPro General Operation User Guide
Table of Contents
General Safety Messages 8
Product Overview 16
Intended Use 16
Contraindications 16
What’s in the Box 17
How the System works 19
Downloading the TytoApp 20
Downloading TytoApp 20
Getting Help 20
First Time Setup 21
What do I need to start working with the Device? 21
Pairing the Device and TytoApp 21
Pairing Procedure 23
Pairing Procedure on First-Time Use 24
Manual Pairing Procedure 31
Using the Device Options Menu to Pair or Shut Down the Device 35
Pairing 35
Identifying the Device Model 35
Pairing External Connected Devices 36
Shutting Down the Device 38
Starting a visit 39
Performing an Identified Visit 41
Logging in 41
Identifying the patient 41
Choosing the the Type of Visit 43
Starting the Visit and Selecting Exams 44
Performing Exams 45
User Role Performing Unguided and Guided Exams 45

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TytoPro General Operation User Guide
Exams and Add-On User Guides 45
Reviewing Recorded Exams 46
Completing the Visit 47
Adding External Exams or Data 47
Using Connected External Devices 49
Sharing the Recorded Visit with a Clinician 51
Viewing the Confirmation screen after Saving a Visit 52
Reviewing and Editing Exams 52
Viewing or Deleting an Exam’s Video 53
Performing an Unidentified Visit 54
User Login (Optional) and Start Unidentified Visit 54
Performing Exams 55
Performing an Online Visit 56
Starting an Online Visit 56
Selecting a Physician 56
Describing the Symptoms 58
Receiving Confirmation and Waiting for the Clinician 58
Joining an Online Visit when the Request is Accepted 58
Using the Phone Stand 59
Clinician Begins Exam 60
Using a Connected External Medical Device 60
Performing the Exam with Poor Network Conditions 60
Completing the Online Visit 61
Viewing the Inbox 61
Viewing the User Settings 62
System Labels and Symbols 63
Explanation of Symbols 63
Technical Specifications 64
Appendix A. Forgot Password 67
Appendix B. Wireless Network Requirements 68

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Appendix C. Frequently Asked Questions and Troubleshooting Tips 69
Appendix D. Electromagnetic Compatibility (EMC) Information 71

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TytoPro General Operation User Guide
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 TytoCare Ltd. (TytoCare).
The safety, reliability, and performance of this Device can only be assured under the following
conditions:
lThe Device has been used for its indicated use and according to the operating instructions in this
User Manual.
lAll fittings, extensions, readjustments, changes, or repairs have been carried out by a TytoCare
authorized representative.
This product is protected by the following US patents: US 10143373, US 8953837, US 10226217
and other pending US patents.
The Device complies with IEC/EN 60601-1 general requirements for safety of medical electrical
equipment and with IEC/EN 60601-1-11 requirements for medical electrical equipment and
medical electrical systems used in the home healthcare environment. The Device complies with
IEC 60601-1-2 Class B requirements for the basic safety and essential performance of medical
electrical equipment and Medical Electrical systems in the presence of electromagnetic
disturbances and to electromagnetic disturbances emitted by medical electrical equipment and
medical electrical systems.
TytoCare reserves the right to change or improve its products and accompanying technical
literature without specific notice of changes or improvements. No part of this publication may be
reproduced, stored in a retrieval system or transmitted in any form by any means, electronic,
mechanical, photo reproductive, recording or otherwise without the express prior written
permission of TytoCare.
TytoCare Support may be contacted at:
For US and Canada: +1 (866) 971-TYTO (8986)
For other countries: [phone]
or [email protected]
Copyright 2016 - 2021 by TytoCare Ltd.

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TytoPro General Operation User Guide
PLEASE READ THIS USER MANUAL BEFORE OPERATING THE SYSTEM.
This first part of the user manual includes all the instructions which are general and common to all
TytoPro Devices. The user manual continues in the followings documents, according to the specific
TytoPro Device that you are using:
●Tyto Otoscope - Document 760-00044
●Tyto Exam Camera - Document 760-00045
●Tyto Thermometer - Document 760-00263
●Tyto Stethoscope - Document 760-00047
PLEASE READ ALL THE ABOVE DOCUMENTS AFTER READING THIS DOCUMENT AND BEFORE
OPERATING THE SYSTEM.

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TytoPro General Operation User Guide
General Safety Messages
General Safety Messages
Warning: A warning indicates precautions to avoid the possibility of personal injury or
death.
lIf the Device packaging, the Device itself or any of its accessories are damaged or not intact -
do not use the Device.
lDo not immerse the Device or any of its accessories in water or in any other liquid. Do not
use a wet Device. If the Device becomes wet, wipe off all moisture and allow at least 48
hours to dry before operating.
lThe system contains no user-serviceable components. Do not disassemble, service or repair
this product or any of its parts.
lDisposal of this Device should be performed in accordance with local regulations.
lIf Device is not working as expected, discontinue use. Refer servicing to qualified service
personnel.
lUse the equipment only for the purpose described, as explained in this user manual.
lDo not use accessories which are not supplied or recommended by the manufacturer.
lDo not remove the covers of the Device components.
lOnly perform maintenance procedures specifically described in this user manual.
lDo not use Device during defibrillator use.
lDo not use the Device on an open wound or on infected skin.
lKeep these instructions for use.

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General Safety Messages
Caution: A caution indicates a condition that may lead to damage to equipment, or a lower
quality of treatment.
lConnect only authorized accessories to the Device.
lIf the LCD screen is broken or cracked, or the image quality is poor, please contact TytoCare
Support.
lIf the LCD screen is dirty, clean the screen with a dry cloth or towel.
lIf the Device does not turn on or initialize properly, or the Splash screen does not appear as
shown , or it cannot be turned off, contact TytoCare Support.
lIf the audible speaker does not sound briefly or the LED does not turn on during system
initialization, contact TytoCare Support.
lIf the LED does not turn on during Throat, Skin or Ears exam, contact TytoCare Support.
lIf you see static artifacts on videos or images, or if the image quality is insufficient, contact
TytoCare Support.
lThe Restore to Factory Defaults action from the menu will erase all Device settings and data
and will restore the Device to its initial as-new state.
lExaminations cannot be done while the Device is charging.
lUse only the charging cable provided with the Device. If the Device does not charge, contact
TytoCare Support.
lUse only a secured Wi-Fi network such as WPA2 wireless encryption.
lIf data or instructions are not displayed on the mobile device during an examination, view
the Device screen.

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General Safety Messages
Note: A note provides other important information.
lIf for any reason you cannot perform the connection between the Device and the TytoCare
App, contact TytoCare Support.
lWhen performing a measurement, a date and time stamp is automatically included with the
recording. If you do not see the date and time of the recording, contact TytoCare Support.
lThe Device connection screen in the TytoCare App should only be used to connect to
another Device or to disconnect from an existing Device.
lOperating conditions: 5° to 40° Celsius (41° to 104° Fahrenheit) / 15% to 70% humidity (non-
condensing).
lFor Tyto Thermometer: 16° - 40° Celsius (60.8° - 104° Fahrenheit).
lStorage conditions: -20° to 60° Celsius / -4° to 140° Fahrenheit / 15% to 70% humidity (non-
condensing).
lWhen charging, the activity LED will be orange for G1 Devices, or purple for G2 Devices.
When charging is complete, it will turn green for G1 Devices, or blue for G2 Devices.
To identify your model (G1 or G2), see Section - Identifying the Device Model.
lThe Device complies with wireless standard IEEE 802.11 g/n (2.4GHz, 5GHz for G2 Devices).
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.
Make sure the tongue depressor holder and otoscope tip are disinfected before each use, using
wipes or cloth moistened with 70% isopropyl alcohol or with pads impregnated with 70% ethyl
alcohol. Thoroughly wipe the tongue depressor holder and otoscope tip and allow it to air dry for
at least two minutes. Discard the disposable tongue depressor blade after use.
Note: As the Tyto Stethoscope is placed directly on the skin, please use wipes or cloth
moistened with 70% isopropyl Alcohol wipes or with pads impregnated with 70% ethyl Alcohol
to disinfect the membrane of the Tyto Stethoscope (black surface touching the skin) before
each use. Thoroughly wipe the membrane of the Tyto Stethoscope and allow it for air dry for
at least two minutes.

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TytoPro General Operation User Guide
General Safety Messages
Use the Q-tip swab, dipped in 70% isopropyl/ethyl alcohol, on narrow and less accessible surfaces,
such as the otoscope lens, or the tongue depressor. Make sure the lens, located at the front of the
camera, is clean.
For professional and hospital use, when using bleach-based and ammonium-based products,
follow the manufacturer’s instructions on the label of the specific disinfectant being used.
Caution: Never use abrasive disinfecting agents, and never soak the Device in water or
other disinfecting liquids.
The instructions provided above have been validated by TytoCare Ltd. as being capable of
preparing the Device and adaptors for reuse.
Repair Policy
When under warranty, repair and service must be performed by TytoCare. When the TytoCare
warranty is expired, repairs may be made by TytoCare or authorized representatives, on a parts
and labor basis.
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.
Warranty
TytoProTM Device Two (2) Years Limited Warranty.
TytoCare warrants the TytoProTM branded product, which includes the base unit, its software and
ancillary parts (the “Product”), to be free from defects in materials and workmanship when used
normally in accordance with TytoCare’s published guidelines for a period of TWO (2) YEARS from
the date of original purchase (“Warranty Period”). Warranty for battery is for one (1) year.
TytoCare’s published guidelines include information contained in this User Manual, the
instructions available on the TytoApp, and in the Product’s technical specifications.
TytoCare does not warrant that the operation of the TytoProTM will be uninterrupted or error-
free. If the Product is determined by TytoCare to be defective during the Warranty Period,
TytoCare shall, at its option, repair or replace the Product free of charge to the original purchaser.
In the event TytoCare cannot repair or replace a product determined to be defective during the
Warranty Period, TytoCare will refund the amount of the original purchase price upon receipt of
proof of purchase. To receive warranty repair or replacement, a warranty claim must be made
during the Warranty Period and within ten (10) days following the discovery of the defect.
For any warranty question please contact TytoCare Support.
lThis warranty is valid only if the sticker at the bottom of the Product is present indicating the
serial number and manufacturing details.

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TytoPro General Operation User Guide
General Safety Messages
lTytoCare is not responsible for damage arising from failure to follow instructions relating to the
use of the Product.
lThe user shall be responsible for proper maintenance and handling of the Product.
lNo warranty is extended if the Product has been altered or modified in any way.
lNo warranty is extended to any Product that has been misused or damaged.
lThis warranty is extended only to the original purchaser of the Product.
lThis warranty does not include problems or product malfunctions caused by the user’s acts (or
failure to act), the acts of others, or events beyond TytoCare’s reasonable control.

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General Safety Messages
NO OTHER WARRANTY
This limited warranty is the only warranty made by TytoCare for the Product. TytoCare MAKES NO
OTHER WARRANTIES, EXPRESS OR IMPLIED, WITH RESPECT TO THE PRODUCT AND EXPRESSLY
DISCLAIMS ALL OTHER WARRANTIES AND CONDITIONS, INCLUDING ANY IMPLIED WARRANTIES OF
MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE, AND TytoCare DOES NOT
REPRESENT THAT THE PRODUCT WILL MEET THE PURCHASER’S OR USER’S REQUIREMENTS.
TytoCare’s sole liability under this warranty will be, at its option, to either repair or replace the
defective Product or to refund or credit the purchase price to the original purchaser. IN NO EVENT
SHALL TytoCare BE LIABLE FOR ANY DAMAGES, INCLUDING BUT NOT LIMITED TO, ANY INDIRECT,
INCIDENTAL, CONSEQUENTIAL, PUNITIVE OR EXEMPLARY DAMAGES, OR DAMAGES FOR
ECONOMIC LOSSES, LOST PROFITS, BUSINESS INTERRUPTION, OR LOST INFORMATION, ARISING
OUR OF YOUR USE OF THE PRODUCT, EVEN IF TytoCare HAS BEEN ADVISED OF THE POSSIBILITY OF
SUCH DAMAGES, WHETHER ARISING OUT OF WARRANTY OR CONTRACT, NEGLIGENCE, STRICT
LIABILITY, OR OTHER TORT. THE USER AGREES THAT UNDER NO CIRCUMSTANCES WILL TytoCare’s
LIABILITY RELATING TO THIS PRODUCT EXCEED THE PURCHASE PRICE PAID FOR THE PRODUCT.

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TytoPro General Operation User Guide
General Safety Messages
FCC Radio frequency interference statement
This equipment has been tested and found to comply with the limits for a Class B digital Device,
pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection
against harmful interference in a residential installation. This equipment generates, uses and can
radiate radio frequency energy and, if not installed and used in accordance with these instructions,
may cause harmful interference to radio communications. However, there is no guarantee that
interference will not occur in a particular installation. If this equipment does cause harmful
interference to radio or television reception, which can be determined by turning the equipment
off and on, the user is encouraged to try to correct the interference by one or more of the
following measures:
lReorient or relocate the receiving antenna.
lIncrease the separation between the equipment and receiver.
lConnect the equipment into an outlet on a circuit different from that to which the receiver is
connected.
lConsult the dealer or an experienced radio/TV technician for help.
TytoCare is not responsible for any radio or communication interference caused by using other
than specified or recommended cables and battery or by unauthorized changes or modifications
to this equipment. Changes or modifications not expressly approved by the manufacturer could
void the user’s authority to operate the equipment.
This Device complies with part 15 of the FCC Rules. Operation is subject to the following two
conditions:
1. This Device may not cause harmful interference, and
2. This Device must accept any interference received, including interference that may cause
undesired operation.
lFCC ID: 2AHKN-K160401 (G1 model)
lFCC ID: 2AHKN-5G2 (G2 model)
To identify your model (G1 or G2), see Section - Identifying the Device Model.

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General Safety Messages
Warning: Canada ISED interference statement
This Device complies with ISED licence-exempt RSS standard(s). Operation is subject to two
conditions:
1. This Device may not cause harmful interference.
2. This Device must accept any interference that may be received or that may cause
undesired operation.
G2: IC: 26056-5G2
Radio Equipment Directive 2014/53/EU
This Device complies with The Radio Equipment Directive 2014/53/EU (RED).

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TytoPro General Operation User Guide
Product Overview
Product Overview
The Tyto Device is a user-friendly electronic device that allows you to perform examinations, and
to optionally transmit the sound, video or image data to a medical professional in another
location.
Tyto Device is used with additional add-on units to perform the following types of examinations:
lLungs
lHeart
lHeart Rate
lEars
lThroat
lBody Temperature
lSkin
lGeneral audio auscultation
Tyto Device connects to the TytoApp on your mobile device (iPhone, iPad, iPad mini, iPod touch or
Android) to facilitate the process of communicating examination data and performing an online
visit with the clinician.
This Device is designed for use by a healthcare professional in a clinical or home environment. It
can be used in a number of scenarios:
lBy an individual clinician/healthcare professional at his clinic
lBy a clinician/healthcare professional, who forwards exam data to another healthcare
professional for later analysis
lBy a clinician/healthcare professional, who collaborates online with another healthcare
professional during or after the exams.
Intended Use
Refer to the relevant user manual for the intended use of Tyto Stethoscope (760-00058), Tyto
Exam Camera (760-00045), Tyto Otoscope (760-00044) and Tyto Thermometer (760-00263).
Contraindications
None known.

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TytoPro General Operation User Guide
What’s in the Box
What’s in the Box
1. Tyto Device Includes an LCD touch screen, main processing unit, rechargeable
battery, camera, illumination, sensors and connector which is
used to mount the add-on devices (see Section - Exams and Add-
On User Guides), and which is held when taking an exam.
2. Otoscope Add-on for ears exam.
3. Stethoscope Add-on for heart and lungs auscultations and measurement of
heart rate.
4. Tongue Depressor Optional tool for throat exam, including a re-usable holder
and disposable blades. There are 2 sizes for the blades:
l10 adult tongue disposable blades.
l10 child tongue disposable blades.
5. Tray Holder for Device and add-ons. To be used during examinations.

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TytoPro General Operation User Guide
What’s in the Box
6. Carrying Case Stores and keeps the entire TytoProTM product, including the Tyto
Device, add-ons, disposables. Note there is a designated place on
the case top to be used as a mobile stand, to hold a mobile device
during examination and online virtual visit.
7. Disposable Ear Specula l10 adult disposable ear specula.
l10 child disposable ear specula.
8. Charging Cable
G1:
G2:
Charging port
Used to charge the Tyto Device, using the UL-certified wall charger
included with your Tyto Device.
Note: The charging cable connector matches your Device
model as follows:
lG1: Proprietary plug.
lG2: USB-C.
To identify your model (G1 or G2), see Section - Identifying the
Device Model.
Note: The Device comes pre-charged. If it does not power on,
connect the charging cable to the Tyto Device to charge it.
Remove the rubber band and connect the charging cable to the
charging port.
Note: For a G1 Device, make sure to connect the charging
cable to the charging port (see picture), not into the nearby
headphones port, which is larger.
Note: You cannot perform exams during the charging process.
It is recommended to fully charge the battery before use.
Note: A LED indicates the charging status as follows:
G1:
oOrange - charging
oGreen - charged
G2:
oPurple - charging
oBlue - charged
Note: Store the Device charged, and re-charge it once every 3
months. Storing the Device when battery is drained may shorten
the battery life.

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TytoPro General Operation User Guide
How the System works
How the System works
The components of the TytoCare system work together to help you communicate with clinicians:

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Downloading the TytoApp
Downloading the TytoApp
Downloading TytoApp
Open the Application store (App Store or Google Play) on your mobile device. Search for TytoCare
and download the free App.
The TytoCare App enables you to perform exams, share the recorded exams with clinicians,
perform online virtual visits with live video conference with the clinician, and obtain exam results
from clinicians. After downloading and installing the TytoCare App on your mobile device, you can
run it from the Apps menu.
Getting Help
You can access the user manual at any time, either before login through the About link, at the top-
left corner of the login screen, or after login, through the menu, accessed through the top-left
corner icon.
You can access the tutorial videos at any time by tapping the help icon on the App.