TytoCare TytoPro User manual

TytoPro
Tyto Basal Thermometer
User Guide
Document Version 3.2
December 2018
Document Number: 760-00046 B01

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TytoPro Tyto Basal Thermometer 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.
© 2018 TytoCare Ltd. All rights reserved.

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TytoPro Tyto Basal Thermometer User Guide
Table of Contents
General Safety Messages/Product Overview 4
General Safety Messages 4
Product Overview 4
Technical Specifications 5
Before the Exam 6
User Role: Performing Guided and Unguided Exams 6
Operation Environment 6
What is Basal Body Temperature 6
Manual Calibration 7
Guided Exam 8
Select the TEMP Exam 8
Video Tutorial and Animation 8
Before You Start How to Conduct the Exam 9
Position the Device 9
Perform the Exam 10
Temperature Display 10
Unguided Exam 12
Select the TEMP Exam 12
Take Temperature Reading from the Forehead 12

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TytoPro Tyto Basal Thermometer User Guide
General Safety Messages/Product Overview
General Safety Messages/Product Overview
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.
Intended Use / Indications for Use
The Tyto Basal Thermometer is an electronic thermometer that enables measuring basal body
temperature (BBT) as an aid in ovulation prediction to aid in conception (not to be used for
contraception).
In addition, the Tyto Basal Thermometer enables storage and transmitting the temperature
measurement to a clinician 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 Basal Thermometer is indicated for use by both adult lay users and clinicians. It can be
used both at home and in clinic environments.
Product Overview
The Tyto Basal Thermometer™ is a user-friendly, electronic thermometer that measures basal
body temperature.
The Tyto Basal Thermometer connects to the Tyto App on your mobile device (iPhone, iPad or iPad
Mini) to facilitate the process of communicating data with clinicians. Recorded results may be
forwarded for review by a clinician in a different location, who should interpret the variations in
basal body temperature to aid in ovulation prediction.

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TytoPro Tyto Basal Thermometer User Guide
General Safety Messages/Product Overview
The Tyto Basal Thermometer is designed for a clinical or home environment, for use in several
scenarios:
●By an individual clinician/healthcare professional
●By a clinician/healthcare professional, who forwards exam data to another
clinician/healthcare professional for later diagnosis
●By a clinician/healthcare professional, who collaborates online with another clinician during
or after the examinations.
●By an adult lay user at home
This infrared thermometer meets requirements established in ASTM Standard (E1965-98). Full
responsibility for the conformance of this product to the standard is assumed by TytoCare Inc.
Technical Specifications
Operating Environment:
(Ambient) Temperature and
Humidity
60.8 - 104°F (16 - 40°C)
15-70% (non-condensing)
Temperature range 94.0° – 108.0°F (34.4°–42.2°C)
Laboratory Accuracy 0.4°F (0.2°C) accuracy for 100.4°F - 105.8°F (38°C - 41°C)
range
0.3°C (0.5°F) accuracy outside the above range.
Complies with ASTM E1965-98 (2009)
Resolution 0.01°F (0.01°C)

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TytoPro Tyto Basal Thermometer User Guide
Before the Exam
Before the Exam
Warning: The Tyto Basal Thermometer should not to be used for contraception
Note: The Tyto Basal Thermometer has been clinically tested and proven to be safe and
accurate when used in accordance to the operation instruction manual. Please note that using
the thermometer not according to the operation, storage and cleaning instructions may lead
to inaccurate temperature measurement.
For cleaning please follow the cleaning instructions described in Section - Cleaning Instructionsof
the General Operation User Guide.
User Role: Performing Guided and Unguided Exams
Two methods can be used for examinations conducted with the TytoProTM system.
Guided exams are intended for any person who is not a healthcare professional, 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.
Unguided exams are intended for healthcare professionals, who have medical knowledge, and are
experienced in measuring temperature. Unguided exams provide a streamlined approach allowing
more flexible recording and faster operation, with minimal instructions for use.
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.
The measurement has to be taken on dry skin. Sweaty skin could impact the results.
Operation Environment
Tyto Basal Thermometer should be operated only in room temperatures of 60.8 - 104 °F / 16 – 40
°C, and humidity of 15 - 70% (non-condensing)
For best accuracy, the Tyto device and patient should remain in the same environment and room
temperature for 30 minutes before performing the measurement.
What is Basal Body Temperature
Basal body temperature is the lowest normal body temperature of a person immediately upon
awakening in the morning. To obtain an accurate basal temperature, you must take your
temperature when you first awake in the morning. For best results, this waking temperature

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TytoPro Tyto Basal Thermometer User Guide
Before the Exam
should be taken at the same time each morning. Since any activity may tend to raise your
temperature, do not get out of bed until you have taken your basal temperature. Postpone going
to the bathroom, eating, smoking or drinking until after taking your basal temperature. Hot drinks,
smoking and exercise cause higher readings. Using an electric blanket or heating pad can affect
your basal temperature. If you use one, it should be kept at the same setting each night
throughout the time you are taking your basal temperature.
The use of charting basal temperature will indicate the slight body changes taking place during the
menstrual cycle (the interval between the beginning of one period and the onset of the next
period). A pattern of temperature fluctuation in the monthly cycle will develop and be noticed. The
slight increase in basal temperature indicates ovulation or fertility by which a pattern of activity to
achieve conception.
Although, the generally accepted “normal” temperature of a healthy person is 98.6°F (37.0°C), the
basal body temperature in the first part of a cycle is usually in a range between 96.5°F (35.8°C)
and 98.0°F (36.7°C). In approximately the last two weeks of the cycle, the basal temperature is
typically 0.5°F (0.3°C) higher.
Note: The shift from the lower to the higher temperature occurs at around the time of ovu-
lation. Since ovulation (the release of an egg (ovum) from the ovary) ordinarily happens only
once during each menstrual cycle, charting basal temperature can be helpful in determining if
and when ovulation occurs. If intercourse takes place at or near this time, during the interval
of the transition between low and high temperature level, conception can take place.
Manual Calibration
The Tyto Basal Thermometer also measures the room temperature to accurately measure your
basal body temperature. The Tyto Basal Thermometer features a self-calibration mechanism,
activated automatically when turned on. Sometimes the device may require a manual calibration,
to verify the room’s ambient temperature to achieve the highest accuracy. In such cases, you’ll be
prompted by the Tyto device to run a short one-step calibration process.
When prompted, you’ll need to aim the
thermometer towards the plastic tray or
towards an inner wall, with some distance,
and then press Start to start the calibration
process, and measure the room
temperature.

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TytoPro Tyto Basal Thermometer User Guide
Guided Exam
Guided Exam
Note: Refer to the TytoProTM General Operation User Guide (Document number: 760-
00046) for preliminary instructions on logging in to the system and viewing the Exam menu.
Select the TEMP Exam
Tap the TEMP (temperature) exam from
the Device screen, and click SUBMIT.
Video Tutorial and Animation
The first time you do the exam, a video tutorial will display. It is always available by clicking the
(question mark) on the top-right of the TytoCare App screen.
Every time you perform a temperature
exam, a short animation displays to remind
you of the key points needed to perform a
successful exam.

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TytoPro Tyto Basal Thermometer User Guide
Guided Exam
Before You Start How to Conduct the Exam
Note: When measuring Basal Body Temperature, measure the temperature immediately
after rising in the morning, before any physical activity, while lying down on the back. It’s
important to measure at the same time every morning for accurate tracking of temperature.
Note: The Infrared temperature sensor is located at the
front of the device:
Position the Device
When you are ready to begin taking the temperature, aim the Tyto Basal Thermometer at the
center of the forehead, just between and above the eyebrows, with a distance of no more than 2
inches (5 cm).
Place The Tyto Basal Thermometer close to
the skin, not exceeding 2 inches (5 cm)
from forehead.
Note: Make sure the forehead is exposed, without hair interfering and not sweat on fore-
head. Also, the patient should be in a relaxed state. Remove any excess perspiration from the
patient’s forehead.

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TytoPro Tyto Basal Thermometer User Guide
Perform the Exam
Perform the Exam
1. Tap START when you are ready to begin
the exam.
2. Hold Tyto steady on the forehead during
one timing circle (3 seconds), until you
hear a beep.
Figure 1-1. Device screen showing correct location on forehead and Start button
Temperature Display
The Tyto Basal Thermometer and the Tyto App show the measured temperature value:
Tap Repeat (in picture here Add) to
measure the temperature again, or
(DONE) when you have finished measuring
the temperature.
Figure 1-2. Measured temperature
Please refer to Section - After the Exam in the General Operation User Guide for further
instructions.
Note: The temperature displayed reflects the basal body temperature, and was adjusted to
be the same as when taken orally.

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TytoPro Tyto Basal Thermometer User Guide
Perform the Exam
Note: The temperature units can be displayed either in Fahrenheit or Celsius units. To
change the temperature units, open the menu on the app (through the upper-left icon on the
Choose Patient screen) and choose Settings. Select the desired units displayed under the Tem-
perature units. To apply the change, you’ll need to log out and log in again.

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TytoPro Tyto Basal Thermometer User Guide
Unguided Exam
Unguided Exam
Note: Refer to the TytoProTM General Operation User Guide for instructions to log in to the
system and view the Exam menu.
Select the TEMP Exam
Tap the TEMP (temperature) exam from
the Device screen. The measurement will
start immediately.
Take Temperature Reading from the Forehead
Note: Make sure the forehead is exposed, without hair interfering. The patient should be in
a relaxed state. Remove any excess perspiration from the patient’s forehead.
Note: The infrared temperature sensor is located
at the front of the device:

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TytoPro Tyto Basal Thermometer User Guide
Unguided Exam
1. Immediately upon tapping TEMP, place the
Thermometer on the patient’s forehead.
2. Aim The Tyto Basal Thermometer at the
center of the forehead, just between and
above the eyebrows, with a distance of no
more than 2 inches (5 cm).
3. A timer will display on the Tyto Basal
Thermometer and the Tyto App.
4. During the six-second timer period, hold
the thermometer over the center of the
forehead. Keep the thermometer close to
the skin, no more than 2 inches (5 cm)
from the skin of the forehead. After 3
seconds, you’ll hear a beep and the
temperature will display.
5. When you have finished taking the
temperature, tap (DONE).
Note: The temperature displayed reflects the basal body temperature, and was adjusted to
be the same as when taken orally.
Note: The temperature units can be displayed either in Fahrenheit or Celsius units. To
change the temperature units, open the menu on the app (through the upper-left icon on the
Choose Patient screen) and choose Settings. Select the desired units displayed under the Tem-
perature units. To apply the change, you’ll need to log out and log in again.
Please refer to Section - After the Exam in the General Operation User Guide for further
instructions on how to complete the exam and send it to a clinician.