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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TytoPro General Operation User Guide
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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TytoPro General Operation User Guide
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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TytoPro General Operation User Guide
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.